%0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e67186 %T A Robust Cross-Platform Solution With the Sense2Quit System to Enhance Smoking Gesture Recognition: Model Development and Validation Study %A Das,Anarghya %A Feng,Juntao %A Brin,Maeve %A Cioe,Patricia %A Schnall,Rebecca %A Huang,Ming-Chun %A Xu,Wenyao %+ Department of Data and Computational Science, Duke Kunshan University, No. 8 Duke Avenue, Kunshan, Jiangsu, 215316, China, 86 51257779988, mingchun.huang@dukekunshan.edu.cn %K smoking cessation %K confounding gestures %K mobile health %K wearable technology %K real-time monitoring %K people living with HIV %K smoking gestures %K smartwatch %K mobile application %K convolutional neural networks %K vaping %K e-cigarette %K mobile phone %D 2025 %7 20.5.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Smoking is a leading cause of preventable death, and people with HIV have higher smoking rates and are more likely to experience smoking-related health issues. The Sense2Quit study introduces innovative advancements in smoking cessation technology by developing a comprehensive mobile app that integrates with smartwatches to provide real-time interventions for people with HIV attempting to quit smoking. Objective: We aim to develop an accurate smoking cessation app that uses everyday smartwatches and an artificial intelligence model to enhance the recognition of smoking gestures by effectively addressing confounding hand gestures that mimic smoking, thereby reducing false positives. The app ensures seamless usability across Android (Open Handset Alliance [led by Google]) and iOS platforms, with optimized communication and synchronization between devices for real-time monitoring. Methods: This study introduces the confounding resilient smoking model, specifically trained to distinguish smoking gestures from similar hand-to-mouth activities used by the Sense2Quit system. By incorporating confounding gestures into the model’s training process, the system achieves high accuracy while maintaining efficiency on mobile devices. To validate the model, 30 participants, all people with HIV who smoked cigarettes, were recruited. Participants wore smartwatches on their wrists and performed various hand-to-mouth activities, including smoking and other gestures such as eating and drinking. Each participant spent 15 to 30 minutes completing the tasks, with each gesture lasting 5 seconds. The app was developed using the Flutter framework to ensure seamless functionality across Android and iOS platforms, with robust synchronization between the smartwatch and smartphone for real-time monitoring. Results: The confounding resilient smoking model achieved an impressive F1-score of 97.52% in detecting smoking gestures, outperforming state-of-the-art models by distinguishing smoking from 15 other daily hand-to-mouth activities, including eating, drinking, and yawning. Its robustness and adaptability were further confirmed through leave-one-subject-out evaluation, demonstrating consistent reliability and generalizability across diverse individuals. The cross-platform app, developed using Flutter (Google), demonstrated consistent performance across Android and iOS devices, with only a 0.02-point difference in user experience ratings between the platforms (iOS 4.52 and Android 4.5). The app’s continuous synchronization ensures accurate, real-time tracking of smoking behaviors, enhancing the system’s overall utility for smoking cessation. Conclusions: Sense2Quit represents a significant advancement in smoking cessation technology. It delivers timely, just-in-time interventions through innovations in cross-platform communication optimization and the effective recognition of confounding hand gestures. These improvements enhance the accuracy and accessibility of real-time smoking detection, making Sense2Quit a valuable tool for supporting long-term cessation efforts among people with HIV trying to quit smoking. International Registered Report Identifier (IRRID): RR2-10.2196/49558 %R 10.2196/67186 %U https://www.jmir.org/2025/1/e67186 %U https://doi.org/10.2196/67186 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 8 %N %P e67267 %T Online Group–Based Dual-Task Training to Improve Cognitive Function of Community-Dwelling Older Adults: Randomized Controlled Feasibility Study %A Chau,Pui Hing %A Cheung,Denise Shuk Ting %A Kwok,Jojo Yan Yan %A Chan,Wai Chi %A Yu,Doris Sau Fung %+ School of Nursing, The University of Hong Kong, 5/F, 3 Sassoon Road, Pokfulam, Hong Kong, China (Hong Kong), 852 39176626, phchau@graduate.hku.hk %K cognitive training %K dual-task %K co-design %K online %K older adults %K Hong Kong %D 2025 %7 16.5.2025 %9 Original Paper %J JMIR Aging %G English %X Background: Cognitive training for older adults is crucial before cognitive impairment emerges. During periods of social distancing like the COVID-19 pandemic, cognitive stimuli are lacking. Online dual-task training is proposed as a solution to address these needs. Objective: We aimed to explore the feasibility, acceptance, and potential effects of online group-based dual-task training as an intervention for enhancing cognitive function among community-dwelling older adults. Methods: A randomized controlled feasibility study was conducted with 76 participants in Hong Kong, randomly assigned to the intervention and attention control groups in a ratio of 2:1 (n=50, 66% and n=26, 34%, respectively). The intervention group underwent 60-minute online dual-task training sessions twice a week for 12 weeks, incorporating cognitive components (upper limb and finger movement, arithmetic operation, and verbal fluency) and physical components (chair-based exercises) developed through a co-design approach. The attention control group received online health talks. Outcomes related to feasibility and acceptance included class attendance and self-reported satisfaction. Main outcomes related to potential effects included the Memory Inventory in Chinese and the Montreal Cognitive Assessment 5 Minutes (Hong Kong Version) at baseline, 6 weeks (midintervention), 12 weeks (postintervention) and 18 weeks (follow-up). Descriptive statistics and linear mixed effects models were used. Effect size was described with Cohen d. Qualitative feedback was collected from 12 informants and analyzed by thematic analysis. Results: About 72% (36/50) of the participants in the intervention group and 62% (16/26) in the control group attended over 75% of the classes. In total, 44 (88%) participants from the intervention group provided acceptance feedback; 82% (36/44) were satisfied and 84% (37/44) would recommend the training to others. Improvement in the Memory Inventory in Chinese score in the intervention group was observed at midintervention, postintervention, and follow-up, with a medium-to-large effect size (d=0.65, 0.43 and 0.85, respectively). Adjusting for baseline values, the between-group differences in the Montreal Cognitive Assessment 5 Minutes (Hong Kong Version) score attained a small-to-medium effect size at midintervention (d=0.34) and postintervention (d=0.23). Qualitative feedback highlighted the timesaving and convenient aspects of online dual-task training, with participants finding the sessions challenging and enjoyable, and reporting benefits across cognitive, physical, and psychosocial domains. However, a preference for traditional in-person training was noted among the older adults despite the advantages of online training. Conclusions: Online dual-task training is a feasible intervention accepted by the older adults, with potential benefits in cognitive abilities. Online training may complement in-person sessions. Further investigation in a full-scale randomized controlled trial is warranted to comprehensively explore its effects and address areas for improvement. Trial Registration: ClinicalTrials.gov NCT05573646; https://clinicaltrials.gov/study/NCT05573646 %M 40378407 %R 10.2196/67267 %U https://aging.jmir.org/2025/1/e67267 %U https://doi.org/10.2196/67267 %U http://www.ncbi.nlm.nih.gov/pubmed/40378407 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e65309 %T Effect of Gamification on Improved Adherence to Inhaled Medications in Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial %A Huang,Xiting %A Jiang,Zhili %A Dai,Yifan %A Liu,Yang %A Dai,Ziying %A Wang,Jing %A Chen,Liping %A Wang,Zhiqian %A Wu,Wenxiao %A Huang,Lihua %+ Department of Nursing, The First Affiliated Hospital Zhejiang University School of Medicine, Building 17, 3rd Floor, 79 Qingchun Road, Hangzhou, 310003, China, 86 13867129329, lihuahuang818@zju.edu.cn %K chronic obstructive pulmonary disease %K COPD %K inhaled medication %K medication adherence %K gamification %K Fogg Behavior Model %K randomized controlled trial %D 2025 %7 14.5.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Inhaled medication is the preferred route of administration for patients with chronic obstructive pulmonary disease (COPD). The compliance rate of inhaled medication in patients with COPD is <50%, which increases the risk of acute exacerbations. Considering the complex steps of inhaled medication, improving inhaled medication compliance not only requires consistent medication frequency and medical advice but also an evaluation of whether the patient has mastered the inhaler technique to achieve the correct dose. Objective: This study aimed to explore the effectiveness of an inhaled medication education program (Inhaling-Health website) based on the Fogg Behavior Model and gamification design on inhaled medication compliance and other health-related outcomes in patients with COPD. Methods: In a randomized, 2-arm, concurrent parallel design, we enrolled 102 patients with COPD from respiratory medicine clinics at 2 hospitals in Zhejiang Province, China, between April and May 2023. Participants were randomly assigned to either the control group (51/102, 50%) or the experimental group (51/102, 50%). All participants completed the intervention, with 94 participants completing 6 months of follow-up. Two independent-sample 2-tailed t tests and the Mann-Whitney U test were used to analyze group differences, and generalized estimating equations were used to analyze repeated measurements. Results: After the intervention, all outcome measures improved compared to baseline. The generalized estimating equation showed that, compared to the control group, the Inhaling-Health website led to a gradual improvement in total adherence-to-inhaler scores starting from 2 months after the intervention (median 51.00, IQR 49.00-52.25 vs median 50.00, IQR 47.00-51.00; Z=–2.014; P=.04). It had a separate positive effect on inhaler technique. In addition, the website was more effective in reducing the modified Medical Research Council score than routine inhaled medication education, starting from 4 months after intervention (median 1.00, IQR 1.00-2.00 vs median 1.00, IQR 0.00-2.00; Z=–2.260; P=.02). The website was also more effective than the conventional intervention in improving Chronic Obstructive Pulmonary Disease Knowledge Questionnaire scores, beginning at the end of the intervention (mean 6.14, SD 1.83 vs mean 7.06, SD 1.82; t1=–2.551; P=.01). Conclusions: The gamified inhaled medication education program based on the Fogg Behavior Model can improve inhaled medication adherence, inhaler technique accuracy, health literacy, lung function, and health-related quality of life; help reduce the severity of dyspnea and COPD physical symptoms; and reduce the risk of acute exacerbations in patients with COPD. This study can provide a reference for inhaled medication education in patients with COPD. Trial Registration: China Clinical Trials Registry (ChiCTR) ChiCTR2300070213; https://www.chictr.org.cn/showprojEN.html?proj=194829 %M 40367505 %R 10.2196/65309 %U https://www.jmir.org/2025/1/e65309 %U https://doi.org/10.2196/65309 %U http://www.ncbi.nlm.nih.gov/pubmed/40367505 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e69351 %T Combining Artificial Intelligence and Human Support in Mental Health: Digital Intervention With Comparable Effectiveness to Human-Delivered Care %A Palmer,Clare E %A Marshall,Emily %A Millgate,Edward %A Warren,Graham %A Ewbank,Michael %A Cooper,Elisa %A Lawes,Samantha %A Smith,Alastair %A Hutchins-Joss,Chris %A Young,Jessica %A Bouazzaoui,Malika %A Margoum,Morad %A Healey,Sandra %A Marshall,Louise %A Mehew,Shaun %A Cummins,Ronan %A Tablan,Valentin %A Catarino,Ana %A Welchman,Andrew E %A Blackwell,Andrew D %+ , ieso Digital Health Ltd, The Jeffreys Building, Cowley Road, Cambridge, CB4 0DS, United Kingdom, 44 0800 074 5560, c.palmer@iesohealth.com %K mental health %K anxiety %K external control %K synthetic control %K digital intervention %K smartphone %K human-in-loop %K AI %D 2025 %7 13.5.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Escalating mental health demand exceeds existing clinical capacity, necessitating scalable digital solutions. However, engagement remains challenging. Conversational agents can enhance engagement by making digital programs more interactive and personalized, but they have not been widely adopted. This study evaluated a digital program for anxiety in comparison to external comparators. The program used an artificial intelligence (AI)–driven conversational agent to deliver clinician-written content via machine learning, with clinician oversight and user support. Objective: This study aims to evaluate the engagement, effectiveness, and safety of this structured, evidence-based digital program with human support for mild, moderate, and severe generalized anxiety. Statistical analyses sought to determine whether the program reduced anxiety more than a propensity-matched waiting control and was statistically noninferior to real-world, propensity-matched face-to-face and typed cognitive behavioral therapy (CBT). Methods: Prospective participants (N=299) were recruited from the National Health Service (NHS) or social media in the United Kingdom and given access to the digital program for up to 9 weeks (study conducted from October 2023 to May 2024). End points were collected before, during, and after the digital program, as well as at a 1-month follow-up. External comparator groups were created through propensity matching of the digital program sample with NHS Talking Therapies (NHS TT) data from ieso Digital Health (typed CBT) and Dorset HealthCare (DHC) University NHS Foundation Trust (face-to-face CBT). Superiority and noninferiority analyses were conducted to compare anxiety symptom reduction (change on the 7-item Generalized Anxiety Disorder Scale [GAD-7]) between the digital program group and the external comparator groups. The program included human support, and clinician time spent per participant was calculated. Results: Participants used the program for a median of 6 hours over 53 days, with 232 of the 299 (77.6%) engaged (ie, completing a median of 2 hours over 14 days). There was a large, clinically meaningful reduction in anxiety symptoms for the digital program group (per-protocol [PP; n=169]: mean GAD-7 change –7.4, d=1.6; intention-to-treat [ITT; n= 99]: mean GAD-7 change –5.4, d=1.1). The PP effect was statistically superior to the waiting control (d=1.3) and noninferior to the face-to-face CBT group (P<.001) and the typed CBT group (P<.001). Similarly, for the ITT sample, the digital program showed superiority to waiting control (d=0.8) and noninferiority to face-to-face CBT (P=.002), with noninferiority to typed CBT approaching significance (P=.06). Effects were sustained at the 1-month follow-up. Clinicians overseeing the digital program spent a mean of 1.6 hours (range 31-200 minutes) of clinician time in sessions per participant. Conclusions: By combining AI and human support, the digital program achieved clinical outcomes comparable to human-delivered care, while significantly reducing the required clinician time by up to 8 times compared with global care estimates. These findings highlight the potential of technology to scale evidence-based mental health care, address unmet needs, and ultimately impact quality of life and reduce the economic burden globally. Trial Registration: ISRCTN Registry ISRCTN52546704; http://www.isrctn.com/ISRCTN52546704 %M 40152000 %R 10.2196/69351 %U https://www.jmir.org/2025/1/e69351 %U https://doi.org/10.2196/69351 %U http://www.ncbi.nlm.nih.gov/pubmed/40152000 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e72925 %T Examining the Effects of the Protection Motivation Theory–Based Online Intervention on Improving the Cognitive Behavioral Outcomes of Caregivers of Children With Atopic Diseases: Quasi-Experimental Study %A Shen,Dequan %A Zhang,Qinzhun %A Tang,Jiayu %A Wu,Jiahui %A Huang,Hui %A Xu,Yuchang %A He,Yinan %A He,Jialu %A Ye,Chengyin %+ Department of Health Management, School of Public Health, Hangzhou Normal University, Room 210, Building 7, Shenyuan, NO.2318, Yuhangtang Rd, Yuhang District, Hangzhou, 311121, China, 86 13588745477, yechengyin@hznu.edu.cn %K cognitive behavioral therapy %K internet-based intervention %K protective motivation theory %K caregivers %K child %K hypersensitivity %K allergy and immunology %K prevention and control %D 2025 %7 13.5.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: The increasing prevalence of pediatric atopic diseases in China poses substantial risks to children’s physical health, mental well-being, and quality of life. Cognitive behavioral interventions for caregivers are effective in managing pediatric atopic diseases. Existing interventions are typically siloed and lack integration across the comorbidities of the atopic march. The protection motivation theory (PMT) could provide an integrated cognitive behavioral intervention framework for addressing shared pathophysiological mechanisms and unifying management strategies across atopic diseases, while online interventions offer advantages in accessibility, cost-effectiveness, and scalability, particularly for caregiver-mediated pediatric care. Objective: This study aimed to develop and evaluate a PMT-based cognitive behavioral online (PMT-CBO) intervention for caregivers of children with atopic diseases, assessing its effects on caregivers’ protective motivation, behavioral intentions, preventive practices, and children’s atopic disease outcomes. Methods: A quasi-experimental design was conducted in 3 health care institutions in Hangzhou, China, where 2 health care institutions were assigned to the PMT-CBO group (127/243, 52.3%) and 1 health care institution was assigned to the control group (116/243, 47.7%). Caregivers in the PMT-CBO group received a 4-week structured course comprising 16 online modules delivered via a WeChat mini-program, whereas controls received routine care with verbal education. Primary outcomes included caregivers’ PMT dimensions (threat appraisal and coping appraisal), behavioral intentions, and preventive behaviors, and secondary outcomes involved children’s symptom severity and medication adherence. The primary outcome scales or questionnaires were designed by the research team, while the secondary outcome scales were derived from established studies. All scales demonstrated good reliability and validity. Intention-to-treat analysis was used. Results: Compared to the control group, the PMT-CBO group demonstrated significant improvements in overall PMT scores (Z=–6.289; P<.001) and most subdimensions (response efficacy, self-efficacy, threat severity, and response cost, with P<.05), except susceptibility (Z=–1.321; P=.19) and reward appraisals (Z=–0.989; P=.32). In the intervention group, caregivers exhibited stronger intentions and partial behavioral optimization (eg, environmental allergen control, with Z=–3.025; P=.002) and children showed improved medication adherence (Z=–4.457; P<.001) and alleviated eczema (Z=–3.112; P=.002) and allergic rhinitis symptoms (Z=–3.277; P<.001), although no significant differences emerged in asthma control (Z=–.830; P=.41) or food allergy–related caregiver burden (Z=–1.693; P=.09). Conclusions: The PMT-CBO intervention enhanced caregivers’ motivation and intentions and children’s medication adherence and eczema and rhinitis outcomes, with a 91.3% (116/127) completion rate via WeChat’s scalable platform. Limited improvements in asthma control and food allergy management implied the future need for additional condition-specific plug-ins, beyond the core PMT-CBO modules. Moreover, merging this PMT-CBO intervention with implementation techniques or ecological frameworks could help address intention-behavior gaps and external barriers, thereby promoting equitable and precision-based allergy care. %M 40358058 %R 10.2196/72925 %U https://www.jmir.org/2025/1/e72925 %U https://doi.org/10.2196/72925 %U http://www.ncbi.nlm.nih.gov/pubmed/40358058 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e64477 %T The Healing Through Ongoing Psychological Empowerment Telehealth Intervention With Two Spirit, Transgender, and Nonbinary Clients of Color in the United States: Open Clinical Trial Feasibility and Implementation Analysis %A Budge,Stephanie Lynne %A Tebbe,Elliot Aaron %A Lee,Joonwoo %A Domínguez Jr,Sergio %A Matsuno,Em %A Lindley,Louis %K Black, Indigenous, people of color %K transgender %K nonbinary %K radical healing %K internalized transnegativity %K open clinical trial %K psychotherapeutic %K lack of competence %K cultural %K humility %K psychotherapy %K therapist %K HOPE %K Healing Through Ongoing Psychological Empowerment %K gender identity %K intervention %K content analysis %K treatment %K medication %K mental health %D 2025 %7 12.5.2025 %9 %J JMIR Form Res %G English %X Background: There is a notable lack of psychotherapeutic services tailored to the needs of Two Spirit, transgender, and nonbinary (2STNB) people of color; research indicates that 2STNB clients who are people of color report a lack of competence and cultural humility on the part of their therapists. Objective: The purpose of this study was to report the feasibility and acceptability of the Healing Through Ongoing Psychological Empowerment (HOPE) teletherapy intervention using deductive content analysis. Methods: We used an open clinical trial design (testing one intervention without a comparison group) to test the feasibility and acceptability of the HOPE intervention. At baseline, 51 clients were enrolled in the open clinical trial, with 49 2STNB clients who are people of color starting and completing the HOPE intervention. Clients were recruited primarily from social media and therapist waitlists. Clients completed up to 15 free face-to-face telehealth psychotherapy sessions that were provided by nine 2STNB therapists who are people of color. Feasibility and acceptability interviews were conducted prior to the intervention, immediately following the intervention, and at 6 months after completing the intervention. Results: The HOPE intervention demonstrated high feasibility and acceptability, specifically regarding data collection, psychometric adequacy, interventionist recruitment or training or retention, delivery of the intervention, acceptability of the intervention to clients, and client engagement with the intervention. Conclusions: These findings propose HOPE as a potentially feasible, culturally specific therapeutic approach for the 2STNB community who are people of color. Future randomized controlled trials comparing HOPE to existing evidence-based treatments are needed. Trial Registration: ClinicalTrials.gov NCT05140174; https://clinicaltrials.gov/study/NCT05140174 %R 10.2196/64477 %U https://formative.jmir.org/2025/1/e64477 %U https://doi.org/10.2196/64477 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e69657 %T Effects of Digital Sleep Interventions on Sleep Among College Students and Young Adults: Systematic Review and Meta-Analysis %A Lu,Yi-An %A Lin,Hui-Chen %A Tsai,Pei-Shan %+ School of Nursing, College of Nursing, Taipei Medical University, No.250, Wuxing Street, Xinyi District, Taipei, 110, Taiwan, 886 2 27361661 ext 6321, ptsai@tmu.edu.tw %K emerging adults %K insomnia %K sleep quality %K technology-assisted sleep interventions %K undergraduate students %D 2025 %7 12.5.2025 %9 Review %J J Med Internet Res %G English %X Background: College students and young adults (18-25 years) frequently experience poor sleep quality, with insomnia being particularly prevalent among this population. Given the widespread use of digital devices in the modern world, electronic device–based sleep interventions present a promising solution for improving sleep outcomes. However, their effects in this population remain underexplored. Objective: We aimed to synthesize current evidence on the effectiveness of electronic device–based sleep interventions in enhancing sleep outcomes among college students and young adults. Methods: In total, 5 electronic databases (PubMed, CINAHL, Cochrane Library, Embase, and Web of Science) were searched to identify randomized controlled trials on digital sleep interventions. Sleep interventions, including cognitive behavioral therapy for insomnia, mindfulness, and sleep education programs delivered via web-based platforms or mobile apps, were evaluated for their effects on sleep quality, sleep parameters, and insomnia severity. Pooled estimates of postintervention and follow-up effects were calculated using Hedges g and 95% CIs under a random-effects model. Heterogeneity was assessed with I2 statistics, and moderator and meta-regression analyses were performed to explore sources of heterogeneity. Evidence quality was evaluated using the Grading of Recommendations Assessment, Development, and Evaluations framework. Results: This study included 13 studies involving 5251 participants. Digital sleep interventions significantly improved sleep quality (Hedges g=−1.25, 95% CI −1.83 to −0.66; I2=97%), sleep efficiency (Hedges g=0.62, 95% CI 0.18-1.05; I2=60%), insomnia severity (Hedges g=−4.08, 95% CI −5.14 to −3.02; I2=99%), dysfunctional beliefs and attitudes about sleep (Hedges g=−1.54, 95% CI −3.33 to −0.99; I2=85%), sleep hygiene (Hedges g=−0.19, 95% CI −0.34 to −0.03; I2=0%), and sleep knowledge (Hedges g=−0.27, 95% CI 0.09-0.45; I2=0%). The follow-up effects were significant for sleep quality (Hedges g=−0.53, 95% CI −0.96 to −0.11; I2=78%) and insomnia severity (Hedges g=−2.65, 95% CI −3.89 to −1.41; I2=99%). Moderator analyses revealed several significant sources of heterogeneity in the meta-analysis examining the effects of digital sleep interventions on sleep outcomes. Variability in sleep quality was influenced by the sleep assessment tool (P<.001), intervention type and duration (P=.001), therapist guidance (P<.001), delivery mode (P=.002), history of insomnia (P<.001), and the use of intention-to-treat analysis (P=.001). Heterogeneity in insomnia severity was primarily attributed to differences in the sleep assessment tool (P<.001), while the effect size on sleep efficiency varied based on intervention duration (P=.02). The evidence quality ranged from moderate to very low certainty across measured outcomes. Conclusions: Digital sleep interventions are effective in improving sleep quality and reducing insomnia severity, with moderate effects on dysfunctional beliefs and attitudes about sleep, sleep hygiene, and sleep knowledge. These interventions offer a viable approach to managing sleep problems in college students and young adults. Trial Registration: PROSPERO CRD42024595126; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024595126 %M 40354636 %R 10.2196/69657 %U https://www.jmir.org/2025/1/e69657 %U https://doi.org/10.2196/69657 %U http://www.ncbi.nlm.nih.gov/pubmed/40354636 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e72892 %T Digital Mental Health Interventions for Young People Aged 16-25 Years: Scoping Review %A Potts,Courtney %A Kealy,Carmen %A McNulty,Jamie M %A Madrid-Cagigal,Alba %A Wilson,Thomas %A Mulvenna,Maurice D %A O'Neill,Siobhan %A Donohoe,Gary %A Barry,Margaret M %+ School of Psychology, Ulster University, Cromore Road, Coleraine, BT52 1SA, United Kingdom, 44 28953675, c.potts@ulster.ac.uk %K digital mental health %K youth %K mHealth %K mobile health %K digital intervention %K mental health promotion %K mental health treatment %K well-being %K scoping review %K PRISMA %D 2025 %7 9.5.2025 %9 Review %J J Med Internet Res %G English %X Background: Digital mental health interventions for young people offer a promising avenue for promoting mental well-being and addressing mental health issues in this population. Objective: This scoping review aims to explore the range of digital mental health interventions available for young people aged 16-25 years, with a particular focus on digital tool types, modalities, delivery formats, target populations, and study retention rates. Methods: The scoping review was conducted in 6 databases (PubMed, Web of Science, Scopus, MEDLINE, Cochrane Library, and PsychInfo). Studies were included if they were published from 2019 to 2024 in English, reported on a population of young people aged 16-25 years, and included validated mental health or well-being outcome measures. All types of digital interventions from promotion and prevention to treatment of mental health were included. Results: After screening 13,306 articles, 145 articles were included in the final review. The findings reveal a diverse landscape of studies, equally focusing on the prevention and promotion of mental health and the treatment of mental ill health, most commonly using cognitive behavioral therapy (63/145, 43.4%). The most common digital tools were apps (51/135, 37.8%), web-based resources (45/135, 33.3%), and websites (19/135, 14.1%). The results highlight the over emphasis on convenience sampling (140/145, 96.6%), with participants mainly recruited from universities or colleges, and a lack of representation from marginalized groups, including lesbian, gay, bisexual, transgender, and queer youth; those from socioeconomically deprived backgrounds; and those who are neurodivergent. Moreover, the focus on anxiety and depression leaves other mental health conditions underrepresented. Retention rates ranged from 16% to 100% and averaged 66% across all studies. Conclusions: There is a need for more research on mental health promotion and prevention measures among those aged younger than 25 years as young people are at increased risk of mental health issues. This includes exploring different intervention approaches and modalities beyond cognitive behavioral therapy and ensuring inclusivity in study populations. Standardizing intervention durations and incorporating long-term follow-up data could provide valuable insights into the efficacy and effectiveness of digital interventions. Future studies should aim for greater inclusivity, ensuring representation from marginalized groups to address the diverse mental health needs of young people effectively. By adopting these approaches, digital mental health interventions can become more accessible, engaging, and impactful for young people worldwide. %M 40344661 %R 10.2196/72892 %U https://www.jmir.org/2025/1/e72892 %U https://doi.org/10.2196/72892 %U http://www.ncbi.nlm.nih.gov/pubmed/40344661 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e73190 %T Development of a 5-Year Risk Prediction Model for Transition From Prediabetes to Diabetes Using Machine Learning: Retrospective Cohort Study %A Zhang,Yongsheng %A Zhang,Hongyu %A Wang,Dawei %A Li,Na %A Lv,Haoyue %A Zhang,Guang %+ Department of Health Management, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, 16766 Jingshi Road, Jinan, 250014, China, 86 19353116378, zgpap2015@126.com %K Chinese population %K CatBoost %K SHAP %K risk factors %K clinical decision support %D 2025 %7 9.5.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Diabetes has emerged as a critical global public health crisis. Prediabetes, as the transitional phase with 5%-10% annual progression to diabetes, offers a critical window for intervention. The lack of a 5-year risk prediction model for diabetes progression among Chinese individuals with prediabetes limits clinical decision-making support. Objective: This study aimed to develop and validate a machine learning–based 5-year risk prediction model of progression from prediabetes to diabetes for the Chinese population and establish an interactive web-based platform to facilitate high-risk patients identifying and early targeted interventions, ultimately reducing diabetes incidence and health care burdens. Methods: A retrospective cohort study was conducted on 2 prediabetes cohorts from 2 Chinese medical centers (primary cohort: n=6578 and external validation cohort: n=2333) tracking from 2019 to 2024. Participants meeting the American Diabetes Association (ADA) criteria (prediabetes: hemoglobin A1c [HbA1c] level of 5.7%-6.4%; diabetes: HbA1c level of ≥6.5%) were identified. A total of 42 variables (demographics, physical measures, and hematologic biomarkers) were collected using standardized protocols. Patients were split into the training (70%) and test (30%) sets randomly in the primary cohort. Significant predictors were selected on the training set using recursive feature elimination methods, followed by prediction model development using 7 machine learning algorithms (logistic regression, random forest, support vector machine, multilayer perceptron, extreme gradient boosting machine, light gradient boosting machine, and categorical boosting machine [CatBoost]), optimized through grid search and 5-fold cross-validation. Model performance was assessed using the receiver operating characteristic curve, the precision-recall curves, accuracy, sensitivity, and specificity as well as multiple other metrics on both the test set and the external test set. Results: During the follow-up of 5 years, 2610 (41.6%) participants and 760 (35.2%) participants progressed from prediabetes to diabetes, with mean annual progression rates of 8.34% and 7.04% in the primary cohort and the external cohort, respectively. Using 14 features selected using the recursive feature elimination-logistic algorithm, the CatBoost model achieved optimal performance in the test set and the external test set with an area under the receiver operating characteristic curve of 0.819 and 0.807, respectively. It also showed the best discrimination performance on the accuracy, negative predictive value (NPV), and F1-scores as well as the calibration performances in both the test set and the external test set. Then the Shapley Additive Explanations (SHAP) analysis highlighted the top 6 predictors (FBG, HDL, ALT/AST, BMI, age, and MONO), enabling targeted modification of these risk factors to reduce diabetes incidence. Conclusions: We developed a 5-year risk prediction model of progression from prediabetes to diabetes for the Chinese population, with the CatBoost model showing the best predictive performance, which could effectively identify individuals at high risk of diabetes. %M 40344663 %R 10.2196/73190 %U https://www.jmir.org/2025/1/e73190 %U https://doi.org/10.2196/73190 %U http://www.ncbi.nlm.nih.gov/pubmed/40344663 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e60889 %T Effectiveness of Mobile Health Interventions for Reducing Sitting Time in Older Adults: Systematic Review and Meta-Analysis %A Chen,Siqing %A Wang,Chenchen %A Ko,Albert %A Garber,Carol Ewing %A Giovannucci,Edward %A Yang,Yuting %A Stults-Kolehmainen,Matthew %A Yang,Lili %+ Department of Nursing, School of Medicine, Sir Run Run Shaw Hospital, Zhejiang University, No. 3 Qingchun East Road, Hangzhou, Zhejiang Province, 310016, China, 86 13429168765, 3200006@zju.edu.cn %K older adults %K sedentary behavior %K health behavior %K community %K systematic review %K meta-analysis %D 2025 %7 8.5.2025 %9 Review %J J Med Internet Res %G English %X Background: Mobile health (mHealth) provides health information through electronic devices, even at home. The escalating prevalence of sedentary behaviors among older adults, which leads to increased adverse health outcomes, underscores the pressing need for a comprehensive understanding of the effectiveness of mHealth interventions. Objective: This study aims to examine the effectiveness of mHealth interventions in the sitting time of older adults (age 55 years). Methods: A systematic review and meta-analysis of randomized controlled trials was conducted to evaluate the effects of mHealth interventions on total sitting time during waking hours, excluding sleep. A literature search was conducted using multiple databases, including PubMed, Embase, Web of Science, and Cochrane, covering articles published from the inception of each database through October 2023. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were explicitly applied to structure this report. Methodological quality was assessed using the Cochrane Risk of Bias (ROB 2) tool for randomized controlled trials and the Methodological Index for Non-Randomized Studies (MINORS) tool for nonrandomized studies. Two independent reviewers screened the studies, extracted data, and assessed methodological quality using established criteria. Meta-analyses were performed using Review Manager (version 5.4; Cochrane Collaboration). Results: Ten studies were identified, of which 3 were included in the meta-analysis, while the remaining 7 were assessed exclusively in the systematic review. The interventions predominantly took place in community settings (n=3) and home-based settings (n=3). Three studies aimed to decrease sedentary behavior and 7 aimed to increase physical activity. The interventions were primarily conducted once daily (n=7) via mobile devices such as smartphones (n=7) and typically involved a single intervention delivered at different time intervals, such as every 15, 20, or 30 minutes (n=4). The interventions typically lasted 12 weeks (n=4) and used objective assessment tools, such as the ActiGraph GT3X+ (n=8). The included studies applied the habit formation theory (n=1), the self-efficacy theory (n=1), the social cognitive theory (n=1), and the social-ecological theory (n=1) as frameworks. Additionally, behavior change techniques, including “goal setting,” “problem-solving,” “action planning,” and “review behavior goal(s)” (n=6), were used. Meta-analysis of the 3 studies included showed a significant decrease in sedentary behavior with mHealth interventions compared with conventional or no interventions (weighted mean difference [WMD]=59.1 min/d, 95% CI 99.1 to 20.2; P=.003). Conclusions: mHealth interventions effectively reduce sitting time in older adults. Strategies using interventions with specific frequencies and durations, dedicated mobile monitoring devices, and behavior change techniques showed the potential to reduce sedentary behavior among older adults. These results also underscore the potential of mHealth as a key tool for promoting the well-being of older adults through technology-driven public health efforts. Trial Registration: PROSPERO CRD42023443926; https://www.crd.york.ac.uk/PROSPERO/view/CRD42023443926 %M 40340833 %R 10.2196/60889 %U https://www.jmir.org/2025/1/e60889 %U https://doi.org/10.2196/60889 %U http://www.ncbi.nlm.nih.gov/pubmed/40340833 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e58024 %T Efficacy of a Self-Guided Internet Intervention With Optional On-Demand Feedback Versus Digital Psychoeducation on Sleep Hygiene for University Students With Insomnia: Randomized Controlled Trial %A Zarski,Anna-Carlotta %A Bernstein,Karina %A Baumeister,Harald %A Lehr,Dirk %A Wernicke,Stella %A Küchler,Ann-Marie %A Kählke,Fanny %A Spiegelhalder,Kai %A Ebert,David Daniel %+ Division of eHealth in Clinical Psychology, Department of Clinical Psychology, Philipps University of Marburg, Schulstraße 12, Marburg, 35032, Germany, 49 6421 28 23314, zarski@staff.uni-marburg.de %K internet intervention %K insomnia %K university students %K randomized controlled trial %K active control group %K cognitive behavioral therapy for insomnia %K CBT-I %D 2025 %7 8.5.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-based cognitive behavioral therapy for insomnia (iCBT-I) provides flexibility but requires significant time and includes potentially challenging components such as sleep restriction therapy. This raises questions about its incremental effectiveness compared to less demanding minimal interventions such as sleep hygiene psychoeducation. Objective: This study aimed to assess the incremental efficacy of self-guided iCBT-I with optional on-demand feedback for university students with insomnia compared to a single session of digital psychoeducation on sleep hygiene. Methods: In a randomized controlled trial, 90 students with insomnia (Insomnia Severity Index ≥10) were randomly allocated to self-help–based iCBT-I (45/90, 50%) or one session of digital sleep hygiene psychoeducation with stimulus control instructions (active control group [aCG]: 45/90, 50%). The self-help–based iCBT-I consisted of 6 sessions on psychoeducation, sleep restriction, and stimulus control, including written feedback on demand from an eCoach. Assessments occurred at baseline (T1), 8 weeks after treatment (T2), and at a 6-month follow-up (T3) via web-based self-assessment and diagnostic telephone interviews. The primary outcome was insomnia severity at T2. Analyses of covariance were conducted in an intention-to-treat sample. Secondary outcomes included diagnoses of insomnia and major depression, sleep quality, sleep efficiency, worrying, recovery experiences, recovery activities, presenteeism, procrastination, cognitive irritation, and recuperation in sleep. Results: There was no difference in insomnia severity at T2 between the iCBT-I group (mean 11.27, SD 5.21) and aCG group (mean 12.36, SD 4.16; F1,989.03=1.12; P=.29; d=–0.26; 95% CI 0.68 to 0.17). A significant difference emerged at T3 (iCBT-I: mean 9.43, SD 5.36; aCG: mean 12.44, SD 5.39; F1,426.15=4.72; P=.03), favoring iCBT-I with a medium effect (d=–0.57; 95% CI 1.07 to –0.06). Most secondary outcomes revealed no significant differences between the groups. In total, 51% (23/45) of participants in the iCBT-I group completed all 6 sessions, and 69% (31/45) completed the 4 core sessions. Conclusions: In the short term, students might benefit from low-intensity, easily accessible digital sleep hygiene psychoeducation or iCBT-I. However, it appears that iCBT-I offers superiority over sleep hygiene psychoeducation in the long term. Trial Registration: German Clinical Trials Register DRKS00017737; https://drks.de/search/de/trial/DRKS00017737 %M 40341194 %R 10.2196/58024 %U https://www.jmir.org/2025/1/e58024 %U https://doi.org/10.2196/58024 %U http://www.ncbi.nlm.nih.gov/pubmed/40341194 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e65368 %T Real-World Effectiveness of Glucose-Guided Eating Using the Data-Driven Fasting App Among Adults Interested in Weight and Glucose Management: Observational Study %A Jospe,Michelle R %A Kendall,Martin %A Schembre,Susan M %A Roy,Melyssa %K precision health %K digital health %K metabolic health %K personalized nutrition %K blood glucose self-monitoring %K biological feedback %K glucose %K blood glucose %K monitoring %K self monitoring %K dietary intervention %K diet %K app engagement %K glucose monitoring %D 2025 %7 8.5.2025 %9 %J JMIR Form Res %G English %X Background: The Data-Driven Fasting (DDF) app implements glucose-guided eating (GGE), an innovative dietary intervention that encourages individuals to eat when their glucose level, measured via glucometer or continuous glucose monitor, falls below a personalized threshold to improve metabolic health. Clinical trials using GGE, facilitated by paper logging of glucose and hunger symptoms, have shown promising results. Objective: This study aimed to describe user demographics, app engagement, adherence to glucose monitoring, and the resulting impact on weight and glucose levels. Methods: Data from 6197 users who logged at least 2 days of preprandial glucose readings were analyzed over their first 30 days of app use. App engagement and changes in body weight and fasting glucose levels by baseline weight and diabetes status were examined. Users rated their preprandial hunger on a 5-point scale. Results: Participants used the app for a median of 19 (IQR 9-28) days, with a median of 7 (IQR 3-13) weight entries and 52 (IQR 25-82) glucose entries. On days when the app was used, it was used a median of 1.8 (IQR 1.4-2.1) times. A significant inverse association was observed between perceived hunger and preprandial glucose concentrations, with hunger decreasing by 0.22 units for every 1 mmol/L increase in glucose (95% CI −0.23 to −0.21; P<.001). Last observation carried forward analysis resulted in weight loss of 0.7 (95% CI −0.8 to −0.6) kg in the normal weight category, 1 (95% CI −1.1 to −0.9) kg in the overweight category, and 1.2 (95% CI −1.3 to −1.1) kg in the obese category. All weight changes nearly doubled when analyzed using a per-protocol (completers) analysis. Fasting glucose levels increased by 0.11 (95% CI 0.09-0.12) mmol/L in the normal range and decreased by 0.14 (95% CI −0.16 to −0.12) mmol/L in the prediabetes range and by 0.5 (95% CI −0.58 to −0.42) mmol/L in the diabetes range. Per-protocol analysis showed fasting glucose reductions of 0.26 (SD 4.7) mg/dL in the prediabetes range and 0.94 (16.9) mg/dL in the diabetes range. Conclusions: The implementation of GGE through the DDF app in a real-world setting led to consistent weight loss across all weight categories and significant improvements in fasting glucose levels for users with prediabetes and diabetes. This study underscores the potential of the GGE to facilitate improved metabolic health. %R 10.2196/65368 %U https://formative.jmir.org/2025/1/e65368 %U https://doi.org/10.2196/65368 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e68846 %T Exploring Therapists’ Approaches to Treating Eating Disorders to Inform User-Centric App Design: Web-Based Interview Study %A Thomas,Pamela Carien %A Bark,Pippa %A Rowe,Sarah %+ Epidemiology and Applied Clinical Research Department, University College London, 4th Floor, Wings A and B, Maple House, 149 Tottenham Court Road, London, W1T 7NF, United Kingdom, 44 0207 679 9000, pamela.thomas.18@ucl.ac.uk %K eating disorders %K binge eating %K bulimia %K anorexia %K qualitative research %K mental health %K smartphone apps %K digital interventions %K eHealth %K mobile health %K artificial intelligence %D 2025 %7 6.5.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: The potential for digital interventions in self-management and treatment of mild to moderate eating disorders (EDs) has already been established. However, apps are infrequently recommended by ED therapists to their clients. Those that are recommended often have poor engagement and user satisfaction, leading to unsatisfactory outcomes. Barriers to recommendation include patient safety, data privacy, and a perception that they may not be effective. Many existing interventions have limited functionality or do not differ much from manual cognitive behavioral therapy (CBT) or self-help books, which may not adequately support the therapeutic process or sustain user engagement. Objective: This study aims to explore the perspectives of therapists who support people with mild to moderate EDs in the community, exploring their existing treatment approach and how an ED app might fit in the treatment pathway alongside treatment. Methods: Semistructured web-based interviews were completed with ED therapists in the United Kingdom. Participants were recruited from First Steps ED, a specialist community-based ED service, and Thrive Mental Wellbeing, a workplace mental health provider. Five main themes were covered: (1) therapists’ treatment approach, (2) how therapy was implemented in practice, (3) strategies for engaging and motivating clients, (4) perspectives on a potential ED app, and (5) suggestions for app content and design. A structured thematic analysis was validated by 2 researchers. Results: Overall, 12 ED and mental health therapists (mean age 28.7, SD 7.3 y; female therapists: n=7, 58%; male therapists: n=5, 42%) participated. Therapists dealing with complex ED issues went beyond traditional CBT using additional therapeutic techniques and a flexible, person-centered approach to treatment. This included engagement and motivational strategies to support the client, elements of which could be mirrored in an app. Therapists identified the therapeutic relationship as key to success, which might have been hard to replicate in an app. They saw the potential for evidence-based apps across all stages of the treatment pathway. The need to address safeguarding, data privacy, and the potential for triggering content within the app was vital. Conclusions: This study advanced our understanding of how to design and develop clinically safe, evidence-based ED apps that can complement therapy by extending the continuity of care and the self-management and psychoeducation of clients. It emphasized integrative, adaptive CBT that incorporated other therapeutic approaches based on individuals’ needs, which could be replicated in an app, as could the strategies to support engagement and motivation. It gave a cautious yet optimistic perspective on the potential integration of apps into ED treatment across all stages of the treatment pathway, from pretreatment maintenance to posttreatment maintenance. It highlighted various concerns that could be addressed and potential limitations, such as the therapeutic relationship, while recognizing the growing potential of apps with rapid technology and artificial intelligence advancements. %M 40327855 %R 10.2196/68846 %U https://formative.jmir.org/2025/1/e68846 %U https://doi.org/10.2196/68846 %U http://www.ncbi.nlm.nih.gov/pubmed/40327855 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e66887 %T The Role of Mobile Apps in Obesity Management: Systematic Review and Meta-Analysis %A Pujia,Carmelo %A Ferro,Yvelise %A Mazza,Elisa %A Maurotti,Samantha %A Montalcini,Tiziana %A Pujia,Arturo %+ Department of Clinical and Experimental Medicine, University Magna Græcia, Viale Europa, Catanzaro, 88100, Italy, 39 09613697565, tmontalcini@unicz.it %K smartphone apps %K weight loss %K weight management %K body composition %K obesity %K meta-analysis %K mHealth %K mobile health %K digital health %K smartphone %K telehealth %K telemedicine %K systematic review %K public health %K overweight %K comorbidity %K BMI %D 2025 %7 6.5.2025 %9 Review %J J Med Internet Res %G English %X Background: Obesity is a growing public health concern worldwide, significantly contributing to premature mortality and noncommunicable diseases. Weight reduction through lifestyle interventions, including diet and physical activity, is the primary approach to combating obesity, with studies showing that a 5% to 10% reduction in body weight can notably reduce obesity-related complications. Recently, smartphone apps have emerged as popular tools to aid in weight loss. However, the effectiveness of smartphone-only apps for weight management in people with overweight or obesity without comorbidities remains unclear. Objective: This meta-analysis aims to evaluate the efficacy of these apps in supporting weight loss and improving body composition in such populations. Methods: A systematic review and meta-analysis were conducted following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, with a search across databases including PubMed, Scopus, Cochrane Library, and others. The inclusion criteria were randomized controlled trials involving adults (aged ≥18 years) with overweight or obesity (BMI≥25 kg/m2) and assessing the use of smartphone-only apps for weight loss. Studies using additional devices or involving participants with comorbidities were excluded. Data extraction focused on weight loss, BMI, waist circumference, and body fat percentage, and the risk of bias was assessed using the Revised Cochrane Risk-of-Bias tool. Results: A total of 11 randomized controlled trials with 1717 participants were included in the meta-analysis. The interventions, lasting between 60 days and 12 months, involved diet and exercise monitoring via smartphone apps. At 4-6 months of follow-up, app-based interventions significantly reduced body weight (standardized mean difference –0.33, 95% CI –0.48 to –0.17; P<.001; I2=49%) and BMI (mean difference [MD] –0.76, 95% CI –1.42 to –0.10; P=.02). Reductions in body fat percentage were also observed at 3 months (MD –0.79, 95% CI –1.38 to –0.20; P=.009) and between 4 and 6 months (MD –0.46, 95% CI –0.71 to –0.20; P<.001). However, no significant effects on waist circumference were noted (P=.07). Conclusions: Smartphone apps demonstrate a modest but statistically significant effect on weight loss and BMI reduction over a 4- to 6-month period in individuals with overweight or obesity. The effectiveness of these interventions appears limited beyond 6 months, with a tendency for weight regain. Many apps lack the personalized support necessary to sustain long-term weight loss, contributing to high dropout rates. Future development of weight loss apps should focus on enhanced customization to improve user adherence and long-term outcomes. Trial Registration: PROSPERO CRD42024570999; https://tinyurl.com/2xw6j4fy %M 40327853 %R 10.2196/66887 %U https://www.jmir.org/2025/1/e66887 %U https://doi.org/10.2196/66887 %U http://www.ncbi.nlm.nih.gov/pubmed/40327853 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 13 %N %P e70473 %T Effectiveness and Implementation Outcomes of an mHealth App Aimed at Promoting Physical Activity and Improving Psychological Distress in the Workplace Setting: Cluster-Level Nonrandomized Controlled Trial %A Watanabe,Kazuhiro %A Sato,Mitsuhiro %A Okusa,Shoichi %A Tsutsumi,Akizumi %K eHealth %K behavioral change %K mobile phone %K smartphone %K workplace %K depression %K anxiety %D 2025 %7 6.5.2025 %9 %J JMIR Mhealth Uhealth %G English %X Background: Encouraging physical activity improves mental health and is recommended in workplace mental health guidelines. Although mobile health (mHealth) interventions are promising for physical activity promotion, their impact on mental health outcomes is inconsistent. Furthermore, poor user retention rates of mHealth apps pose a major challenge. Objective: This study aimed to examine the effectiveness and implementation outcomes of the smartphone app ASHARE in Japanese workplace settings, leveraging a deep learning model to monitor depression and anxiety through physical activity. Methods: This hybrid effectiveness-implementation trial was a 3-month nonrandomized controlled trial conducted from October 2023 to September 2024. Work units and employees were recruited and allocated to the intervention or active control group based on preference. The intervention group installed the ASHARE app, whereas the control group participated in an existing multicomponent workplace program promoting physical activity. Changes in physical activity and psychological distress levels were compared between the groups. User retention rates, participation rates, acceptability, appropriateness, feasibility, satisfaction, and potential harm were also assessed. Results: A total of 84 employees from 7 work units participated (67 from 5 units in the intervention group and 17 from 2 units in the control group). In total, 78 employees completed the 3-month follow-up survey (follow-up rate: 93%). Both groups showed increased physical activity, and the intervention group showed reduced psychological distress; however, the differences between groups were not statistically significant (P=.20; P=.36). In a sensitivity analysis of protocol-compliant employees (n=21), psychological distress levels were significantly reduced in the intervention group compared with the control group (coefficient=−3.68, SE 1.65; P=.03). The app’s 3-month user retention rate was 20% (12/61), which was lower than the participation rate in each component of the control programs. Implementation outcomes evaluated by employees were less favorable in the intervention group than in the control group, whereas health promotion managers found them to be similar. Conclusions: The ASHARE app did not show superior effectiveness compared with an existing multicomponent workplace program for promoting physical activity. An implementation gap may exist between health promotion managers and employees, possibly contributing to the app’s low user retention rate. Future research should focus on examining the effectiveness of strategies to get engagement from managers and from segments of employees with favorable responses in the workplace at an early stage. Trial Registration: UMIN-CTR UMIN000052374; https://tinyurl.com/4x4dxfv6 %R 10.2196/70473 %U https://mhealth.jmir.org/2025/1/e70473 %U https://doi.org/10.2196/70473 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e54727 %T Impact of a Digital Decision Aid When Choosing Between Face-to-Face and Guided Internet-Based Psychological Interventions for Depression Among Chinese-Speaking Participants in Hong Kong: Randomized Controlled Trial %A Auyeung,Larry %A Mak,Winnie WS %A Tsang,Ella Zoe %A Yang,Philo Liu %+ School of Arts and Humanities, Tung Wah College, 136A, Nathan Road, Kowloon, 999077, China (Hong Kong), 852 31906792, larryauyeung@twc.edu.hk %K decision aid %K shared decision-making %K guided internet-based psychological interventions %K ICBT %K depression %D 2025 %7 6.5.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: The expansion of e-mental health services offers diverse treatment options. As the variety of available interventions grows, helping individuals navigate these options effectively becomes essential. Objective: This study evaluates the effects of a decision aid for users when choosing between guided internet-based psychological interventions and in-person psychotherapy. Methods: A web-based, randomized controlled trial was conducted with 148 Chinese-speaking adult participants from Hong Kong with Patient Health Questionnaire-9 (PHQ-9) scores ≥10 (indicating clinical depression). Participants were recruited by electronic direct mail, social media, university mass mail, and online advertising then randomly assigned to either the decision aid intervention group or the attention control group. The study’s assessments were conducted online through self-administered questionnaires before and after the intervention, while the intervention was delivered via Zoom. The decision aid group underwent a brief interactive, self-directed, web-based decision aid. The decision aid included psychoeducation on depression and treatments, a comparison between internet-based interventions and face-to-face therapy, and personalized reports for value clarification. The attention control involved an unguided web search on mental health information. Primary outcome measures included decision conflict (measured using the SURE tool and Decision Conflict Scale), while secondary outcomes included stage of decision-making, satisfaction with decision, perceived benefits and risks, and likelihood of service utilization. Results: Time-by-intervention interactions in ANOVA were found, which indicated that the reduction in decisional conflict was more significant in the decision aid group than in the control group, as measured using the brief SURE tool (F1,145=6.47, P=.01; partial η2 = 0.043; 95% CI 0.002-0.122) and decision conflict scale (F1,136=9.56, P=.002; 95% CI 0.0086-0.16). Specifically, interaction effects were observed for 3 of the 5 decision conflict subscales: The decision aid group reported feeling more “informed,” experiencing greater “support,” and being better able to make “effective decisions.” Participants in the decision aid group also reported more advanced stages of decision-making; however, a significant difference between groups was not found for satisfaction with the decision. Although there was no significant change in perceived benefit, participants in the decision aid group had significantly greater reductions in their perceived risks associated with a guided internet-based psychological intervention. In addition, participants who used the decision aid were 2.26 times more likely to prefer (odds ratio [OR] 2.26, 95% CI 1.11-4.60; P=.02) and 2.53 times more likely to use (OR 2.53, 95% CI 1.13-4.92; P=.006) a guided internet-based psychological intervention than participants who searched for mental health information on the web by themselves. Conclusions: This study demonstrates the extent of the utility and value of a decision aid for assisting individuals with depressive symptoms make informed choices related to e-mental health. Decision aids may facilitate the uptake of digital mental health services. Future research should explore the behavioral and long-term impact and generalizability of decision aids in applied settings. Trial Registration: Chinese Clinical Trial Register ChiCTR2300077323; https://tinyurl.com/2n34ea69; ClinicalTrials.gov NCT05477420; https://clinicaltrials.gov/study/NCT05477420 %M 40327376 %R 10.2196/54727 %U https://www.jmir.org/2025/1/e54727 %U https://doi.org/10.2196/54727 %U http://www.ncbi.nlm.nih.gov/pubmed/40327376 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 13 %N %P e70228 %T The Impact of Technology-Enabled Medical Nutrition Therapy on Weight Loss in Adults With Overweight and Obesity: Retrospective Observational Study %A Hu,Emily A %A Kelley,Tommy %A Haryani,Ajay %+ Nourish, Floor 15, 853 Broadway, New York, NY, 10003, United States, 1 929 460 8273, emily.hu@usenourish.com %K medical nutrition therapy %K mHealth %K obesity %K overweight %K registered dietitian %K smartphone application %K telehealth %K virtual %K weight loss %D 2025 %7 6.5.2025 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Obesity represents a major public health crisis in the United States, imposing substantial health risks and economic costs. Medical nutrition therapy (MNT) is an evidence-based treatment where a registered dietitian provides personalized nutrition and lifestyle guidance to patients. MNT has been demonstrated to be effective for weight loss and managing chronic diseases in patients with obesity. With the rise of telehealth, MNT has gained popularity as an accessible alternative to traditional in-person care. While a nationwide program integrating MNT with a companion mobile app offers a comprehensive weight management solution, data supporting its clinical effectiveness is limited. Objective: This study aimed to evaluate the effectiveness of an MNT program with a companion mobile app on weight loss among adults with overweight and obesity. Methods: This retrospective cohort study included users of Nourish, an MNT program with a companion mobile app, who attended at least 1 appointment between August 2023 and October 2024 and had a baseline BMI≥30 kg/m² or a BMI between 27-30 kg/m² with diabetes or prediabetes. The primary outcome was the proportion of participants who achieved at least 5% weight loss; secondary outcomes included mean weight change, mean percent weight change, and the proportion of participants who achieved at least 3% weight loss. Statistical significance of weight change was determined using 2-tailed t tests. Subgroup analyses were performed by sex, BMI, follow-up time between weights, number of appointments completed, and levels of engagement according to appointment frequency and app usage. Results: In total, 3951 participants were included in the analysis. The mean age was 38 (SD 10) years, and 78% (3082/3951) of participants were female. Weight loss was reported as a program goal by 70% (2748/3951) of participants, while 31% (1204/3951) and 24% (939/3951) reported diabetes or prediabetes and a cardiovascular condition, respectively. Over a median follow-up of 2.2 months, 17% (689/3951) of participants achieved at least 5% weight loss. The mean weight change was –4.5 (SD 8.9) pounds, corresponding to a mean percent weight change of –2% (SD 3.9; P<.001). Males and participants aged 60 years or older were more likely to experience at least 5% weight loss. Longer follow-up time between weights and a higher number of completed appointments (≥5 appointments) were significantly associated with a significantly higher likelihood of achieving at least 5% weight loss (P<.001 for both). In addition, participants who were most engaged, based on appointment frequency and app usage, were more likely to achieve at least 5% weight loss compared with those who were less engaged (P<.001). Conclusions: Engagement with an MNT program and companion mobile app is associated with significant weight loss for adults with overweight and obesity and may serve as an effective, scalable weight management solution. %M 40327381 %R 10.2196/70228 %U https://mhealth.jmir.org/2025/1/e70228 %U https://doi.org/10.2196/70228 %U http://www.ncbi.nlm.nih.gov/pubmed/40327381 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 11 %N %P e65960 %T Comparison of Electronic Surveillance With Routine Monitoring for Patients With Lymphoma at High Risk of Relapse: Prospective Randomized Controlled Phase 3 Trial (Sentinel Lymphoma) %A Le Dû,Katell %A Chauchet,Adrien %A Sadot-Lebouvier,Sophie %A Fitoussi,Olivier %A Fontanet,Bijou %A Saint-Lezer,Arnaud %A Maloisel,Frédéric %A Rossi,Cédric %A Carras,Sylvain %A Parcelier,Anne %A Balavoine,Magali %A Septans,Anne-Lise %K patient-reported outcome measures %K lymphoma %K risk of relapse %K relapse %K randomized trial %K web-based %K quality of life %K survival %K detection %K progression %K T-cell lymphoma %K Hodgkin lymphoma %D 2025 %7 6.5.2025 %9 %J JMIR Cancer %G English %X Background: Relapse is a major event in patients with lymphoma. Therefore, early detection may have an impact on quality of life and overall survival. Patient-reported outcome measures have demonstrated clinical benefits for patients with lung cancer; however, evidence is lacking in patients with lymphoma. We evaluated the effect of a web-mediated follow-up application for patients with lymphoma at high risk of relapse. Objective: This study aims to demonstrate that monitoring patients via a web application enables the detection of at least 30% more significant events occurring between 2 systematic follow-up consultations with the specialist using an electronic questionnaire. Methods: We conducted a prospective, randomized phase 3 trial comparing the impact of web-based follow-up (experimental arm) with a standard follow-up (control arm). The trial was based on a 2-step triangular test and was designed to have a power of 90% to detect a 30% improvement in the detection of significant events. A significant event was defined as a relapse, progression, or a serious adverse event. The study covered the follow-up period after completion of first-line treatment or relapse (24 months). Eligible patients were aged 18 years and older and had lymphoma at a high risk of relapse. In the experimental arm, patients received a 16-symptom questionnaire by email every 2 weeks. An email alert was sent to the medical team based on a predefined algorithm. The primary objective was assessed after the inclusion of the 40th patient. The study was continued for the duration of the analysis. Results: A total of 52 patients were included between July 12, 2017, and April 7, 2020, at 11 centers in France, with 27 in the experimental arm and 25 in the control arm. The median follow-up was 21.3 (range 1.3‐25.6) months, and 121 events were reported during the study period. Most events occurred in the experimental arm (83/119, 69.7%) compared with 30.2% (36/119) in the control arm. A median number of 3.5 (range 1-8) events per patient occurred in the experimental arm, and 1.8 (range 1-6) occurred in the control arm (P=.01). Progression and infection were the most frequently reported events. Further, 19 patients relapsed during follow-up: 6 in the experimental arm and 13 in the control arm (P<.001), with a median follow-up of 7.7 (range 2.8‐20.6) months and 6.7 (range 1.9‐16.4) months (P=.94), respectively. Statistical analysis was conducted after including the 40th patient, which showed no superiority of the experimental arm over the control arm. The study was therefore stopped after the 52nd patient was enrolled. Conclusions: The primary objective was not reached; however, patient-reported outcome measures remain essential for detecting adverse events in patients with cancer, and the electronic monitoring method needs to demonstrate its effectiveness and comply with international safety guidelines. Trial Registration: ClinicalTrials.gov NCT03154710; https://clinicaltrials.gov/ct2/show/NCT03154710 %R 10.2196/65960 %U https://cancer.jmir.org/2025/1/e65960 %U https://doi.org/10.2196/65960 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e65970 %T Cognitive Behavioral Immersion for Depression: Protocol for a Three-Arm Randomized Controlled Trial of Peer-Based Coaching in the Metaverse %A Robinson,Noah %A Ramos,Francisco N %A Hollon,Steven D %A Han,Gloria T %A Ezawa,Iony D %+ Department of Psychology, University of Southern California, 3620 S McClintock Avenue, Los Angeles, CA, 90089, United States, 1 2137402203, ezawa@usc.edu %K cognitive behavioral immersion %K virtual reality %K anxiety %K mental health %K depression %K stress %K protocol %K randomized controlled trial %K RCT %K coaching %K metaverse %K behavioral therapy %K skills training intervention %D 2025 %7 6.5.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Depression and anxiety are among the most common mental health concerns globally. Efficacious treatments such as cognitive behavioral therapy exist but remain difficult to access and scale. Cognitive behavioral immersion (CBI)—a cognitive behavioral skills training intervention delivered by peer coaches in the metaverse—has been developed to address these barriers. CBI can be used through a virtual reality headset or via flat-screen devices such as phones, tablets, or computers. Pilot data have established its usability among participants with clinical levels of depression and anxiety. However, more research is needed to determine whether CBI causes decreases in these symptoms and how delivery via virtual reality compares to flat-screen devices. Objective: This protocol aims to conduct a randomized controlled trial evaluating the efficacy of immersive CBI accessed via a virtual reality headset (CBI-VR) as compared to a less immersive (but more accessible) CBI condition accessed via a flat-screen device (CBI-FS) and each to a delayed access control (DAC). Methods: A total of 306 adults experiencing clinical levels of depressive symptoms are being recruited nationally to participate in this web-based trial. Participants will be randomized according to a 1:1:1 ratio to one of three conditions: (1) CBI-VR, (2) CBI-FS, and (3) DAC. The CBI program consists of eight weekly 60-minute group sessions led by trained peer coaches who teach cognitive behavioral skills. The acute period of each condition will last 8 weeks with a follow-up period of 6 months. The primary outcome is depressive symptoms; secondary outcomes are anxiety symptoms and quality of life. Outcomes will be assessed once at baseline, weekly during the course of the intervention, and monthly during follow-ups. We will use hierarchical linear models to assess differences in the rate of symptom change among conditions. We will also explore potential prognostic (demographics and immersion) and prescriptive (cognitive behavioral skills, group alliance, and program engagement) predictors, as well as potential mechanisms (cognitive change and social support) of response. Results: We hypothesize that participants randomized to either CBI group will experience greater symptom improvement than those in DAC and that CBI-VR participants will improve more than CBI-FS participants. This study was funded in September 2023. Data collection began in February 2024. As of January 2025, all 306 participants have been enrolled. Data collection should conclude by September 2025. Data have not yet been analyzed. Expected results to be submitted for publication in the winter of 2025. Conclusions: This trial will determine if CBI via either device is efficacious as compared to DAC and whether virtual reality enhances outcomes. Findings will contribute to the literature on using the metaverse and virtual reality to facilitate effective accessible mental health interventions, particularly for depression. Trial Registration: ClinicalTrials.gov NCT06418997; https://clinicaltrials.gov/study/NCT06418997 International Registered Report Identifier (IRRID): DERR1-10.2196/65970 %M 40327374 %R 10.2196/65970 %U https://www.researchprotocols.org/2025/1/e65970 %U https://doi.org/10.2196/65970 %U http://www.ncbi.nlm.nih.gov/pubmed/40327374 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e68084 %T Effectiveness and Mechanisms of a Digital Mindfulness–Based Intervention for Subthreshold to Clinical Insomnia Symptoms in Pregnant Women: Randomized Controlled Trial %A Wang,Juan %A Yang,Qiuhong %A Cui,Naixue %A Wu,Liuliu %A Zhang,Xuan %A Sun,Yaoyao %A Huang,Yongqi %A Cao,Fenglin %+ School of Nursing and Rehabilitation, Cheeloo College of Medicine, Shandong University, 44 Wenhua Xi Road, Jinan, 250012, China, 86 53188382291, caofenglin2008@126.com %K digital interventions %K mindfulness-based interventions %K pregnant women %K prenatal insomnia %K sleep during pregnancy %K randomized controlled trial %K mechanisms of change %D 2025 %7 5.5.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Prenatal insomnia symptoms are prevalent, debilitating, and largely untreated; yet, there is a lack of empirically supported and accessible interventions. Mindfulness-based interventions have been theoretically hypothesized to alleviate insomnia symptoms by counteracting adverse sleep-related cognitive and behavioral processes, although few studies have tested them. Objective: This study aimed to examine the effectiveness and potential mechanisms of a digital mindfulness-based intervention targeted at prenatal insomnia (dMBI-PI) in reducing insomnia symptoms. Methods: A single-blind randomized controlled trial was conducted from October 2021 to February 2023. A total of 160 eligible pregnant women (mean age 30.54, SD 3.86 years) with subthreshold to clinical insomnia symptoms (corresponding to a score of ≥8 on the Insomnia Severity Index) were recruited from obstetrics clinics and then randomized 1:1 into the intervention group (the 6-week dMBI-PI plus standardized care) or the control group (standardized care). The primary outcome was the insomnia symptoms assessed at baseline, immediately after the intervention, 2 months after the intervention (approximately the third trimester), and 42 days post partum. The secondary outcomes included insomnia remission rates and reliable change rates, sleep onset latency, wake after sleep onset, total sleep time, sleep efficiency, sleep quality, fatigue symptoms, daytime sleepiness, anxiety, and depressive symptoms. The hypothesized mediators included sleep-specific rumination, sleep-specific worry, presleep arousal, sleep-related attentional bias, and maladaptive behaviors. All outcomes were self-assessed through web-based questionnaires. Linear mixed model analysis was conducted to examine the dMBI-PI’s effects. Results: Compared with the control group, the intervention group had significantly greater improvements in insomnia symptoms from baseline to the end of the intervention (mean between-group difference –2.02, 95% CI –3.42 to –0.62; P=.005; Cohen d=0.46, 95% CI 0.01-0.92) and from baseline to the third trimester (mean between-group difference –2.02, 95% CI –3.42 to –0.61; P=.005; Cohen d=0.46, 95% CI 0.01-0.92), but a beneficial effect was not observed post partum. The intervention group had a significantly increased likelihood of achieving insomnia remission or reliable change at the third trimester; however, we did not observe significant between-group differences in the changes in most secondary outcomes. The changes in adverse cognitive and behavioral processes (mainly sleep-specific worry and presleep arousal) significantly mediated the dMBI-PI’s effect on prenatal insomnia symptoms. Conclusions: The dMBIs showed significant short-term benefits for prenatal insomnia symptoms by mitigating sleep-specific worry and presleep arousal and may therefore hold promise as a first-step, pragmatic, and accessible option for pregnant women at risk of insomnia. Trial Registration: Chinese Clinical Trial Register (ChiCTR) ChiCTR2100052269; https://tinyurl.com/4bb8f7ah %M 40324172 %R 10.2196/68084 %U https://www.jmir.org/2025/1/e68084 %U https://doi.org/10.2196/68084 %U http://www.ncbi.nlm.nih.gov/pubmed/40324172 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e66463 %T Effectiveness of Self-Training With a Web-Based Digital Health Application Versus Physiotherapy in the Treatment of Disorders of the Patella: Randomized Controlled Trial %A Mayer,Tobias A %A Koska,Daniel %A Harsch,Ann-Kathrin %A Maiwald,Christian %+ Department of Research Methodology and Data Analysis in Biomechanics, Institute of Human Movement Science and Health, Chemnitz University of Technology, Thüringer Weg 11, Chemnitz, 09126, Germany, 49 371 531 36030, tobias.mayer@hsw.tu-chemnitz.de %K M22 %K disorders of the patella %K randomized controlled trial %K RCT %K DiGA %K physiotherapy %K digital health application %D 2025 %7 5.5.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Disorders of the patella are among the most prevalent knee injuries. While exercise therapy is widely accepted as an effective treatment strategy, the positive effects of conventional exercise therapy under the guidance of a physiotherapist may be offset by inherent limitations, such as difficulties in scheduling appointments or statutory policies restricting the number of training sessions. Home-based exercise interventions using digital health applications (DHAs) may help address some of these limitations. Objective: This study aimed to assess the efficacy of a 12-week exercise intervention using a web-based DHA for improving knee function and reducing pain in patients with disorders of the patella (International Classification of Diseases code M22). Methods: The outcomes of the DHA intervention group (IG) were compared to a control group (CG) that received conventional physiotherapy covered by statutory health insurance in Germany (SHI-PT). A total of 259 patients with diagnosed disorders of the patella were included in the trial and randomly allocated to IG DHA (n=136, 52.5%) and CG SHI-PT (n=123, 47.5%). Two primary end points were examined: “knee function” (Knee Injury and Osteoarthritis Outcome Score—Activities of Daily Living [KOOSADL] subscale, range 0-100 points) and “knee pain” (visual analog scale [VAS], range 0-100 points). Participants were asked to complete 2 surveys: one before the first therapy session (PRE) and one after completing the treatment period of 12 weeks (POST). Results: Training with the DHA resulted in a 4.5-fold greater improvement in “knee function” (PRE–POST differences in KOOSADL score; IG DHA: 15.7 points, 95% CI 13.7-17.6 vs CG SHI-PT: 3.5 points, 95% CI 1.5-5.5) and a 3.5-fold greater reduction in “knee pain” (PRE–POST differences in VAS pain score; IG DHA: –22.5 points, 95% CI –25.2 to –19.9 vs CG SHI-PT: –6.5 points, 95% CI –8.7 to –4.4) compared to SHI-PT. The improvements in IG DHA exceeded the limits of clinical relevance. The differences between the treatment groups (KOOSADL score –10.1 points, 95% CI –infinity to -8.0; VAS pain score 14.3 points 95% CI 11.7-infinity) were statistically significant (P<.001) for both end points in favor of IG DHA. No effect was found for age or sex. The reported use of pain medication decreased substantially in IG DHA, and showed almost no change in CG SHI-PT. Conclusions: Our findings indicated that the investigated DHA is superior to SHI-PT for treating disorders of the patella. Therefore, DHA has been approved by the German Federal Institute for Drugs and Medical Devices for treating disorders of the patella in persons of all sexes aged ≥12 years. Trial Registration: German Clinical Trials Register (DRKS) DRKS00023454; https://drks.de/search/en/trial/DRKS00023454 %M 40323642 %R 10.2196/66463 %U https://www.jmir.org/2025/1/e66463 %U https://doi.org/10.2196/66463 %U http://www.ncbi.nlm.nih.gov/pubmed/40323642 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e63162 %T Assessing a Digital Tool to Screen and Educate Survivors of Domestic Violence on Affordable Housing Programs in New York City: Protocol for a Mixed Methods Feasibility Study %A Tan,Jennifer K %A Kaufman,Michelle R %+ Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, 2213 McElderry Street, Suite 441, Baltimore, MD, 21205, United States, 1 667 306 9747, MichelleKaufman@jhu.edu %K domestic violence %K intimate partner violence %K homelessness %K housing %K feasibility study %K digital intervention %K digital solution %D 2025 %7 2.5.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Extant research has long documented the association between domestic violence and homelessness. Yet, there appear to be few interventions to address the housing needs of survivors of domestic violence, and none on a digital platform. Objective: Our primary objective is to determine the feasibility of a full-scale intervention trial of a web-based tool that screens and educates survivors of domestic violence on affordable housing programs in New York City. Our secondary objectives are to assess the perceived usability and acceptability of the tool. Methods: The study will take place in a community-based domestic violence center in New York City. Treatment will consist of study participants not using (SC) or using (SC+) the tool, in or outside of private meetings with a case manager to discuss housing and other benefits. The frequency of the meetings will vary depending on the participant’s needs. The study will measure changes in housing knowledge, housing self-efficacy, and staff trust through two electronic surveys, administered at times 0 and 2 weeks. Following a historical cohort control group design, we will sequentially recruit participants, starting with SC and followed by SC+. After data collection for SC+ ends, we will invite staff from the partner site to individual, web-based interviews to share their experiences of and recommendations for implementing the tool. Results: Recruitment for the SC arm commenced in March 2022 and was completed in April 2023. After a year, 23 participants completed the study: 75 were screened, 44 were deemed eligible, 35 enrolled, and in the end, 23 participants completed baseline and follow-up surveys. Given the length of time it took to recruit for SC and the limited time overall that we had for the study, the study team decided to follow an expedited recruitment timeline for SC+. Recruitment for SC+ commenced in January 2024 and is anticipated to end by May 2024. Recruitment for the staff interviews will take place in June 2024. We expect to complete the study and be ready to compile the results by the end of June 2024. Conclusions: The protocol describes a feasibility study that can inform future research on housing or digital tools for a similar study population. Data from the study will also be used to inform revisions to the tool. International Registered Report Identifier (IRRID): DERR1-10.2196/63162 %M 40315453 %R 10.2196/63162 %U https://www.researchprotocols.org/2025/1/e63162 %U https://doi.org/10.2196/63162 %U http://www.ncbi.nlm.nih.gov/pubmed/40315453 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 13 %N %P e67151 %T Clinical Impact of Personalized Physician’s Education and Remote Feedback Via a Digital Platform on Glycemic Control: Pilot Randomized Controlled Trial %A Yu,Jin %A Lee,Joonyub %A Yang,Yeoree %A Lee,Eun Young %A Lee,Seung-Hwan %A Cho,Jae-Hyoung %+ Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Banpodaero 222, Seoul, 06591, Republic of Korea, 82 222586007, drhopper@ikoob.com %K type 2 diabetes mellitus %K digital health %K education, distance %K remote patient monitoring %K distance counseling %D 2025 %7 1.5.2025 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The digital education platform Doctorvice (iKooB Inc.) offers face-to-face physician-patient education during outpatient clinic visits, remote glucose monitoring, and the delivery of educational messages, and is expected to be effective for personalized diabetes care. Objective: This study aims to evaluate the effectiveness of the digital education platform for diabetes care by comparing cases that included both face-to-face education and remote monitoring with those that included only face-to-face education. Methods: This was a randomized clinical study conducted at the Diabetes Center of Seoul St. Mary’s Hospital. Participants were aged ≥19 years and had glycated hemoglobin (HbA1c) levels between 7.5% and 9.5%. In the intervention group, physicians used the digital education platform to provide face-to-face education at enrollment and at the 3- and 6-month visits, along with remote monitoring during the first 3 months of the 6-month study period. The control group received conventional outpatient education. Both groups completed questionnaires—assessing satisfaction with diabetes treatment, diabetes-related stress, and adherence to diabetes medication—at the beginning and end of the study. The primary endpoint was the change in HbA1c levels. Results: A total of 66 participants were enrolled between August 1, 2022, and August 31, 2023. Of these, 26 in the intervention group and 30 in the control group were analyzed, excluding 10 participants who dropped out of the study. The mean baseline HbA1c levels were 8.3% (SD 0.6%) in the intervention group and 8.0% (SD 0.5%) in the control group. At the 3-month follow-up, mean HbA1c decreased by 0.5%-7.8% (SD 0.9%; P=.01) in the intervention group and by 0.2%-7.8% (SD 0.7%) in the control group. HbA1c levels substantially improved during the first 3 months with both face-to-face education and remote glucose monitoring. However, HbA1c tended to increase during the 3- to 6-month follow-up in the intervention group without the remote monitoring service. Satisfaction with diabetes treatment significantly improved at the end of the study compared with baseline in the intervention group (mean change +3.6 points; P=.006). Medication adherence improved in both groups, with no significant difference at 6 months (P=.59), although the intervention group showed a greater increase from baseline. Subgroup analysis indicated that the reduction in HbA1c was greater for patients with baseline HbA1c levels ≥8.0%, those aged ≥65 years, smokers, drinkers, and those with obesity in the intervention group. Conclusions: The digital education platform for personalized diabetes management may be beneficial for glycemic control in type 2 diabetes mellitus. Its effectiveness appears to be enhanced when physicians provide personalized face-to-face education combined with remote feedback. Trial Registration: Clinical Research Information Service (CRiS) of Republic of Korea KCT0007953; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=23507&search_page=L %M 40310669 %R 10.2196/67151 %U https://mhealth.jmir.org/2025/1/e67151 %U https://doi.org/10.2196/67151 %U http://www.ncbi.nlm.nih.gov/pubmed/40310669 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e64735 %T Improving Diet Quality of People Living With Obesity by Building Effective Dietetic Service Delivery Using Technology in a Primary Health Care Setting: Protocol for a Randomized Controlled Trial %A Kerr,Deborah A %A Collins,Clare E %A Begley,Andrea %A Mullan,Barbara %A Dhaliwal,Satvinder S %A Pulker,Claire E %A Zhu,Fengqing %A Fialkowski,Marie %A Prince,Richard L %A Norman,Richard %A James,Anthony P %A Aveyard,Paul %A Mitchell,Helen %A Garton-Smith,Jacquie %A Rollo,Megan E %A Maxwell-Smith,Chloe %A Hassan,Amira %A Breare,Hayley %A Butcher,Lucy M %A Pollard,Christina M %+ Curtin School of Population Health, Curtin University, Kent Street, Bentley, 6102, Australia, 61 892664122, d.kerr@curtin.edu.au %K obesity %K diet %K diet quality %K digital behavioral interventions %K health behavior change %K mHealth %K mobile health %K eHealth %K mobile food record %K telemedicine %K weight management %K obese %K RCT %K randomized controlled trial %K Australia %K adult %K nutrition %K dietitians %K access %K dietary management %K intervention %K digital health %D 2025 %7 30.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Almost a third of Australian adults are living with obesity, yet most cannot access medical nutrition therapy from dietitians, that is, the health professionals trained in dietary weight management services. Across the health system, primary care doctors readily identify people who may benefit from weight management services, but there are limited referral options in the community. Dietitians are trained to provide evidence-informed dietary treatment of overweight and obesity but are underutilized and underresourced. The chat2 (Connecting Health and Technology 2) trial will test combining new technologies for dietary assessment with behavior change techniques to improve outcomes for people living with obesity. Objective: This study aimed to compare the effectiveness of a 1-year digital dietary intervention, with standard care on body weight reduction and improved diet quality, in adults living with obesity delivered by dietitians in a primary care setting. Methods: This randomized controlled trial will compare a 1-year, digitally tailored, feedback dietary intervention with a control group in 430 adults living with obesity (BMI≥30 to ≤45 kg/m2). Participants will be recruited by letters sent to individuals randomly selected from the electoral roll and supplemented by hospital site posters, newsletters, and unaddressed mailbox delivery postcards sent to residential street points. The primary outcome is change in body weight, measured face-to-face at a baseline, 6 months, and 12 months. A 4-day, image-based dietary assessment tool (mobile Food Record) will be used to measure diet quality score. Secondary outcomes include diet quality score; dual-energy absorptiometry body composition; and total cholesterol, triglyceride, low-density lipoprotein, high-density lipoprotein, glycated hemoglobin, and fasting glucose levels. The intervention group will receive 8 video counseling sessions with a trained dietitian delivered over 12 months to support dietary behavior change and relapse prevention. The trial is unblinded. Both groups will receive feedback on their clinical chemistry and dual-energy absorptiometry scans at each time point. Results: Participant recruitment commenced in July 2023 and ended in August 2024. Data analysis will commence in 2025, with the anticipated publication of results in 2026. Conclusions: If found to be effective, the results of this randomized controlled trial will support the delivery of effective, evidence-based weight management advice using new technologies. Improving community access to high-quality dietetic services will ensure more effective use of the dietetic workforce to improve outcomes for people living with obesity. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12622000803796; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383838 International Registered Report Identifier (IRRID): DERR1-10.2196/64735 %M 40306629 %R 10.2196/64735 %U https://www.researchprotocols.org/2025/1/e64735 %U https://doi.org/10.2196/64735 %U http://www.ncbi.nlm.nih.gov/pubmed/40306629 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e46113 %T Low Earth Orbit Communication Satellites: A Positively Disruptive Technology That Could Change the Delivery of Health Care in Rural and Northern Canada %A Hamilton,Douglas %A Kohli,Sandeep (Sonny) S %A McBeth,Paul %A Moore,Randy %A Hamilton,Keltie %A Kirkpatrick,Andrew W %+ General Internal Medicine, Faculty of Medicine, University of Calgary, 1403 29 St NW, Foothills Hospital, Calgary, AB, T2N 2T9, Canada, 1 403 969 6095, doctorhami@gmail.com %K telemedicine %K telementored medicine %K space medicine %K virtual medicine %K medical informatics %K low earth orbit satellites %K rural %K Canada %K remote %K stress %K virtual care %K medical care %K utility %K COVID-19 %K patient %K availability %K satellite %K mobile phone %D 2025 %7 30.4.2025 %9 Viewpoint %J J Med Internet Res %G English %X Canada is a progressive nation that endeavors to provide comprehensive, universal, and portable health care to all its citizens. This is a challenge for a country with a population of 40 million living within a land expanse of 10 million km2 and where 18% live in rural or highly remote locations. The combined population of Yukon, Northwest Territories, and Nunavut is only 128,959 (0.32% of the population), living within 3.92 million km2, and many of these citizens live in isolated communities with unique health needs and social issues. The current solution to providing health care in the most remote locations has been to transport the patient to the health care provider or vice versa, which incurs considerable financial strain on our health care system and personal stress to the patient and provider. The recent global deployment of low Earth orbit communication satellites (LEO-ComSats) will change the practice and availability of online medicine everywhere, especially in northern Canada. The deployment of LEO-ComSats could result in disruptive but positive changes in medical care for underserved communities in remote geographic locations across Canada. LEO-ComSats can be used to demonstrate online medical encounters between a patient and a doctor in Canada, separated by thousands of kilometers. Most certainly, the academic medical centers in lower Canada could perform online telementored medical care to our northern communities like the remote care provided to many Canadians during the COVID-19 pandemic. An online health care model requires effective design, testing, and validation of the policies, standards, requirements, procedures, and protocols. Although the COVID-19 pandemic was the initial prime mover across all of Canada in the use of online medical encounters and creating rapidly devised reimbursement models, it was nonetheless created reactively, using real-time managerial fiat and poorly defined procedures based on minimal pedagogical experience, which made it “difficult to prove it was universally safe.” It is essential to proactively derive the medical policies, standards, and procedures for telementored medicine and “prove it is safe” before LEO-ComSat technology is ubiquitously deployed in northern Canada. This viewpoint was written by subject matter experts who have researched online and internet-based medicine for many years, sometimes 3 decades. In many cases, a literature review was not necessary since they already had the articles in the bibliography or knowledge in their possession. In many cases, internet search engines (ie, Google or PubMed) and Canadian government documents were used to provide corroborating evidence. %M 40306625 %R 10.2196/46113 %U https://www.jmir.org/2025/1/e46113 %U https://doi.org/10.2196/46113 %U http://www.ncbi.nlm.nih.gov/pubmed/40306625 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e66889 %T Effect of a Digital Health Exercise Program on the Intention for Spinal Surgery in Adult Spinal Deformity: Exploratory Cross-Sectional Survey %A Brown,Marsalis Christian %A Lin,Christopher Quincy %A Jin,Christopher %A Rohde,Matthew %A Rocos,Brett %A Belding,Jonathan %A Woods,Barrett I %A Ackerman,Stacey J %K adult spinal deformity %K scoliosis %K nonoperative management %K spinal realignment therapy %K digital health %K program evaluation %D 2025 %7 29.4.2025 %9 %J JMIR Form Res %G English %X Background: Adult spinal deformity (ASD) is a prevalent condition estimated at 38%. Symptomatic ASD is associated with substantial health care costs. The role of nonoperative interventions in the management of ASD remains elusive. The National Scoliosis Clinic’s (NSC) scoliosis realignment therapy (SRT) is a personalized digital health exercise program for the nonoperative management of ASD. Objective: This exploratory study had two objectives: (1) to evaluate the effect of the SRT program on users’ intention of having spinal fusion; and (2) from a US payer perspective, to estimate the annual cost savings per 100,000 beneficiaries by averting spinal surgery. Methods: Individuals were enrolled in the SRT study from October 1, 2023 to September 1, 2024. Participants completed a web-based, cross-sectional survey about their history of prior scoliosis surgery and intent of having surgery before and after use of SRT (on a 4-point Likert scale, where 1 = “No Intent for Surgery” and 4 = “High Intent for Surgery”). Intent for surgery before and after participation in SRT was compared using a nonparametric Wilcoxon signed-rank test for paired data. Annual cost savings per 100,000 beneficiaries by averting spinal fusions were estimated separately for commercial payers and Medicare using published literature and public data sources. Payer expenditures were inflation-adjusted to 2024 US dollars using the Hospital Services component of the Consumer Price Index. Results: A total of 62 NSC members (38.8%) responded to the survey and were enrolled in the SRT program for an average (SD) of 17 (12) weeks. The mean (SD) age was 65.3 (13.5) years, and the majority were female (47/48, 98%) and White (45/46, 98%). Among the SRT users who did not have prior scoliosis surgery (n=56), 14% (8/56) reported a decrease in intent for surgery (that is, a lower Likert score) with the use of SRT. The mean (SD) intent for surgery scores before compared to after SRT were 1.29 (0.53) and 1.14 (0.35), respectively (mean difference 0.15 [P=.006]). Participants with “No Intent for Surgery” pre- versus postuse of SRT (42/56 versus 48/56, respectively) corresponded to an absolute risk reduction of 11% and a number needed to treat of 9 to avert one spinal fusion. Among the 6 participants who transitioned to “No Intent” for spinal surgery with the use of SRT, 3 were aged <65 years and 3 were ≥65 years of age. The annual cost savings from averted spinal surgeries were estimated at US $415,000 per 100,000 commercially-insured beneficiaries and US $617,000 per 100,000 Medicare beneficiaries. Conclusions: SRT is a personalized, scoliosis-specific digital health exercise program with the potential for averting 1 spinal surgery for every 9 participants, resulting in a substantial reduction in payer expenditures while improving the quality of care for commercial payers and Medicare beneficiaries. %R 10.2196/66889 %U https://formative.jmir.org/2025/1/e66889 %U https://doi.org/10.2196/66889 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e56855 %T Impact of the Kidney Score Platform on Communication About and Patients’ Engagement With Chronic Kidney Disease Health: Pre–Post Intervention Study %A Tuot,Delphine %A Crowley,Susan %A Katz,Lois %A Leung,Joseph %A Alcantara-Cadillo,Delly %A Ruser,Christopher %A Talbot-Montgomery,Elizabeth %A Vassalotti,Joseph %K chronic kidney disease %K CKD %K CKD communication %K CKD knowledge %K patient activation %K kidney %K kidney score platform %K kidney health %K United States %K US %K adult %K aging %K clinical practice %K awareness campaign %K health information %K clinician %K primary care %K longitudinal intervention %K web-based %K mobile health %K mHealth %D 2025 %7 29.4.2025 %9 %J JMIR Form Res %G English %X Background: Chronic kidney disease (CKD) affects 14% of the US adult population, yet patient knowledge about kidney disease and engagement in their kidney health is low despite many CKD education programs, awareness campaigns, and clinical practice guidelines. Objective: We aimed to examine the impact of the Kidney Score Platform (a patient-facing, risk-based online tool that provides interactive health information tailored to an individual’s CKD risk plus an accompanying clinician-facing Clinical Practice Toolkit) on individual engagement with CKD health and CKD communication between clinicians and patients. Methods: We conducted a pre-post intervention study in which English-speaking veterans at risk for CKD in two primary care settings interacted with the Kidney Score platform’s educational modules and their primary care clinicians were encouraged to review the Clinical Practice Toolkit. The impact of the Kidney Score on the Patient Activation Measure (the primary outcome), knowledge about CKD, and communication with their clinician about kidney health was determined with paired t tests. Multivariable linear and logistic models were used to determine whether changes in outcomes after versus before intervention were influenced by age, race or ethnicity, sex, and diabetes status, accounting for baseline values. Results: The study population (n=76) had a mean (SD) age of 64.4 (8.2) years, 88% (67/76) was male, and 30.3% (23/76) self-identified as African-American. Approximately 93% (71/76) had hypertension, 36% (27/76) had diabetes, and 9.2% (7/76) had CKD according to the laboratory criteria but without an ICD-10 (International Classification of Diseases, 10th Edition) diagnosis. Patient interaction with the Kidney Score did not change the mean Patient Activation Measure (preintervention: 40.7%, postintervention: 40.2%, P=.23) but increased the mean CKD knowledge score (preintervention: 40.0%, postintervention 51.1%, P<.01), and changed the percentage of veterans who discussed CKD with their clinician (preintervention: 12.3%, postintervention: 31.5%, P<.01). Changes did not differ by age, sex, race, or diabetes status. Results were limited by the small sample size due to low recruitment and minimal clinician engagement with the Clinical Practice Toolkit during the COVID-19 pandemic. Conclusions: One-time web-based tailored education for patients can increase CKD knowledge and encourage conversations about kidney health. Increasing patient activation for CKD management may require multilevel, longitudinal interventions that facilitate ongoing conversations about kidney health between patients and clinician teams. %R 10.2196/56855 %U https://formative.jmir.org/2025/1/e56855 %U https://doi.org/10.2196/56855 %0 Journal Article %@ 2817-092X %I JMIR Publications %V 4 %N %P e70589 %T Effectiveness of Artificial Intelligence–Based Platform in Administering Therapies for Children With Autism Spectrum Disorder: 12-Month Observational Study %A Atturu,Harini %A Naraganti,Somasekhar %A Rao,Bugatha Rajvir %K autism spectrum disorder %K neurodevelopmental disorders %K applied behavior analysis %K software %K artificial intelligence %D 2025 %7 28.4.2025 %9 %J JMIR Neurotech %G English %X Background: A 12-month longitudinal observational study was conducted on 43 children aged 2‐18 years to evaluate the effectiveness of the CognitiveBotics artificial intelligence (AI)–based platform in conjunction with continuous therapy in improving therapeutic outcomes for children with autism spectrum disorder (ASD). Objective: This study evaluates the CognitiveBotics software’s effectiveness in supporting children with ASD through structured, technology-assisted learning. The primary objectives include assessing user engagement, tracking progress, and measuring efficacy using standardized clinical assessments. Methods: A 12-month observational study was conducted on children diagnosed with ASD using the CognitiveBotics AI-based platform. Standardized assessments, include the Childhood Autism Rating Scale (CARS), Vineland Social Maturity Scale, Developmental Screening Test, and Receptive Expressive Emergent Language Test (REEL), were conducted at baseline (T1) and at the endpoint (T2). All participants meeting the inclusion criteria were provided access to the platform and received standard therapy. Participants who consistently adhered to platform use as per the study protocol were classified as the intervention group, while those who did not maintain continuous platform use were designated as the control group. Additionally, caregivers received structured training, including web-based parent teaching sessions, reinforcement strategy training, and home-based activity guidance. Results: Participants in the intervention group demonstrated statistically significant improvements across multiple scales. CARS scores reduced from 33.41 (SD 1.89) at T1 to 28.34 (SD 3.80) at T2 (P<.001). Social age increased from 22.80 (SD 7.33) to 35.76 (SD 9.09; mean change: 12.96, 56.84% increase; P<.001). Social quotient increased from 53.26 (SD 11.84) to 64.75 (SD 16.12; mean change: 11.49, 21.57% increase; P<.001). Developmental age showed an improvement from 30.93 (SD 9.91) to 45.31 (SD 11.20; mean change: 14.38, 46.49% increase; P<.001), while developmental quotient increased from 70.94 (SD 10.95) to 81.33 (SD 16.85; mean change: 10.39, 14.65% increase; P<.001). REEL scores showed substantial improvements, with receptive language increasing by 56.22% (P<.001) and expressive language by 59.93% (P<.001). In the control group, while most psychometric parameters showed some improvements, they were not statistically significant. CARS scores decreased by 10.62% (P=.06), social age increased by 52.27% (P=.06), social quotient increased by 19.62% (P=.12), developmental age increased by 44.88% (P=.06), and developmental quotient increased by 11.23% (P=.19). REEL receptive and expressive language increased by 34.69% (P=.10) and 40.48% (P=.054), respectively. Conclusions: Overall, the platform was an effective supplement in enhancing therapeutic outcomes for children with ASD. This platform holds promise as a valuable tool for augmenting ASD therapies across cognitive, social, and developmental domains. Future development should prioritize expanding the product’s accessibility across various languages, ensuring cultural sensitivity and enhancing user-friendliness. %R 10.2196/70589 %U https://neuro.jmir.org/2025/1/e70589 %U https://doi.org/10.2196/70589 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e64010 %T Mobile Health–Based Motivational Interviewing to Promote SARS-CoV-2 Vaccination in Rural Adults: Protocol for a Pilot Randomized Controlled Trial %A Braun,Ashlea %A Corcoran,Sarah %A Tu Doan,Khue %A Jernigan,Cameron %A Moriasi,Cate %A Businelle,Michael %A Bui,Thanh %+ Health Promotion Sciences, Hudson College of Public Health, University of Oklahoma Health Sciences, 4502 E 41st Street, Tulsa, OK, 74135, United States, 1 5672401582, ashlea-braun@ouhsc.edu %K motivational interviewing %K vaccination hesitancy %K community-based participatory research %K rural health %K mobile health %K mHealth %D 2025 %7 28.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite documented effectiveness, the public health impact of vaccinations is severely limited by misperceptions, hesitancy, and poor acceptance. Messaging from health care providers has not yet been optimized to overcome these barriers and has not been tailored to groups that face health disparities, such as rural Americans. Because vaccines have become controversial, as illustrated by the public response to the SARS-CoV-2 vaccines, traditional approaches that use persuasive education or advice to change perspectives are unlikely to have long-term effects and may even be counterproductive. Alternatively, motivational interviewing (MI) is a conversational approach to address modifiable behavior and its empathic nature can be useful when navigating challenging topics. Although MI has been found to be efficacious in improving vaccination rates among children and adolescents, it is unknown whether MI can reduce vaccine hesitancy and health disparities among underserved rural adults. Further, the ideal mode of delivery for MI is unknown, especially “dose,” “intensity,” and integration with mobile health (mHealth). Therefore, it is essential to investigate the efficacy of MI in promoting vaccine uptake in rural populations to reduce health disparities. Objective: This study aims to develop and evaluate the feasibility, acceptability, and preliminary efficacy of our mHealth-based MI intervention to diminish SARS-CoV-2 vaccine hesitancy (MOTIVACC). Methods: This pilot study uses mixed methods. A 2-phase study will be conducted: convening a community advisory panel to understand barriers and facilitators to vaccination and mHealth uptake among adults (phase 1, n=16-20), and a pilot 3-group single-blind randomized controlled trial (RCT) for 8 weeks (phase 2, N=60). In the RCT, we recruit adults who have received no previous dose of the COVID-19 vaccine and randomize them into one of three arms: standard MI (SMI; n=20), intensive MI (IMI; n=20), or mHealth-based MOTIVACC (n=20). The primary RCT outcomes are positive change in vaccine hesitancy and intention to obtain the vaccines, measured on Likert scales. The secondary RCT outcome is the actual vaccine receipt. Results: Phase 1 of this study was approved by the ethics committees of both the University of Oklahoma and Oklahoma State University in July 2022, and was completed in June 2023. Phase 2 of this study was approved by the ethics committee at the University of Oklahoma in April 2024. Conclusions: This randomized trial will evaluate the preliminary efficacy of MI for targeting SARS-CoV-2 vaccine hesitancy, as well as compare traditional MI versus mHealth-based MI. This will provide pivotal data on scalable strategies to assist in navigating vaccine hesitancy, including in rural populations. Trial Registration: ClinicalTrials.gov NCT05977192; https://clinicaltrials.gov/study/NCT05977192 International Registered Report Identifier (IRRID): DERR1-10.2196/64010 %M 40294409 %R 10.2196/64010 %U https://www.researchprotocols.org/2025/1/e64010 %U https://doi.org/10.2196/64010 %U http://www.ncbi.nlm.nih.gov/pubmed/40294409 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 11 %N %P e59519 %T Use of Behavior Change Techniques in Digital HIV Prevention Programs for Adolescents and Young People: Systematic Review %A Mo,Phoenix Kit-han %A Xie,Luyao %A Lee,Tsz Ching %A Li,Angela Yuen Chun %+ Center for Health Behaviours Research, JC School of Public Health and Primary Care, Chinese University of Hong Kong, No. 30-32 Ngan Shing Street, Hong Kong, China (Hong Kong), 852 22528765, phoenix.mo@cuhk.edu.hk %K HIV %K prevention %K adolescent %K young adult %K behavior change techniques %D 2025 %7 28.4.2025 %9 Review %J JMIR Public Health Surveill %G English %X Background: HIV infections have caused severe public health and economic burdens to the world. Adolescents and young people continue to constitute a large proportion of newly diagnosed HIV cases. Digital health interventions have been increasingly used to prevent the rising HIV epidemic. Behavior change techniques (BCTs) are intervention components designed to modify the underlying processes that regulate behavior. The BCT taxonomy offers a systematic approach to identifying, extracting, and coding these components, providing valuable insights into effective intervention strategies. However, few reviews have comprehensively identified the use of BCTs in digital HIV interventions among adolescents and young people. Objective: This study aimed to synthesize existing evidence on the commonly used BCTs in effective digital HIV prevention programs targeting adolescents and young people. Methods: In total, 4 databases (PubMed, Embase, Cochrane Library, and APA PsycINFO) were searched, and studies from January 2008 to November 2024 were screened. Reference lists of relevant review studies were reviewed to identify any additional sources. Eligible randomized controlled trials with 1 of 3 HIV prevention outcomes (ie, HIV knowledge, condom-use self-efficacy, and condom use) were included. Basic study characteristics, intervention strategies, and study results were extracted and compared for data analysis. For the included interventions, BCTs were identified according to the BCT taxonomy proposed by Abraham and Michie in 2008, and the frequencies of BCTs used in these interventions were counted. Results: Searches yielded 383 studies after duplicates were removed, with 34 (8.9%) publications finally included in this review. The most frequently used BCTs included prompting intention formation (34/34, 100%), providing information about behavior-health link (33/34, 97%), providing information on consequences (33/34, 97%), and providing instruction (33/34, 97%). Interventions with significant improvements in HIV knowledge (11/34, 32%) more frequently used BCTs with a provision nature, such as providing information about behavior-health link (11/11, 100%), information on consequences (11/11, 100%), encouragement (10/11, 91%), and instruction (10/11, 91%). Those with significant increases in condom-use self-efficacy (7/34, 20%) used BCTs toward initiating actions, such as prompts for intention formation (7/7, 100%), barrier identification (7/7, 100%), and practice (5/7, 71%). In addition, studies showing significant improvements in condom use (14/34, 41%) included BCTs focused not only on provision and initiation but also on behavioral management and maintenance, such as use follow-up prompts (5/14, 36%), relapse prevention (4/14, 29%), prompt self-monitoring of behavior (3/14, 21%), and prompt review of behavioral goals (3/14, 21%). Conclusions: This is the first systematic review that examined the use of BCTs in digital HIV prevention interventions for adolescents and young adults. The identified BCTs offer important reference for developing more effective digital interventions, with implications for enhancing their HIV knowledge, condom-use self-efficacy, and condom use in youth. %M 40293783 %R 10.2196/59519 %U https://publichealth.jmir.org/2025/1/e59519 %U https://doi.org/10.2196/59519 %U http://www.ncbi.nlm.nih.gov/pubmed/40293783 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e63111 %T Technology-Based HIV Prevention Interventions for Men Who Have Sex With Men: Systematic Review and Meta-Analysis %A Huang,Wenting %A Stegmueller,Daniel %A Ong,Jason J %A Wirtz,Susan Schlueter %A Ning,Kunru %A Wang,Yuqing %A Mi,Guodong %A Yu,Fei %A Hong,Chenglin %A Sales,Jessica M %A Liu,Yufen %A Baral,Stefan D %A Sullivan,Patrick S %A Siegler,Aaron J %+ Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, 1518 Clifton Rd, Atlanta, GA, 30322, United States, 1 4048199070, wenting.huang@emory.edu %K HIV %K men who have sex with men %K telemedicine %K systematic review %K Bayesian %K meta-analysis %D 2025 %7 28.4.2025 %9 Review %J J Med Internet Res %G English %X Background: There remain unmet HIV prevention needs in China, particularly among gay, bisexual, and other men who have sex with men. Technology-based interventions are increasingly used in HIV prevention worldwide. Objective: We aimed to conduct a systematic review and meta-analysis of studies to assess the effectiveness of technology-based HIV prevention interventions to improve HIV testing and consistent condom use in China. Methods: We searched English-language (PubMed and MEDLINE, Embase, and Web of Science) and Chinese-language (Wanfang, WEIPU, and China National Knowledge Infrastructure) databases for technology-based HIV prevention intervention studies published between January 1, 2004, and September 30, 2021. Eligible studies were technology-based HIV prevention intervention studies with outcomes of HIV testing or condom use among men who have sex with men or transgender women using randomized controlled or nonrandomized pretest-posttest designs in China. The intervention technologies identified were apps, web pages, and other types of electronic communications (eg, email, SMS text messages, and video messages). A Bayesian meta-analysis was conducted to estimate the pooled effect size and 95% credible interval (CrI). We added study and intervention features as covariates to explore their associations with the study effects. Study quality was assessed using the integrated quality criteria for review of multiple study designs. Publication bias was assessed using funnel plots and robust Bayesian meta-analyses. Results: We identified 1214 and 1691 records from English-language and Chinese-language databases, respectively. A total of 141 records entered full-text screening, and 24 (17%) studies were eligible for the review. Approximately half (14/24, 58%) of the interventions were delivered through social media platforms, predominantly using message-based communication. The remaining studies used email and web-based platforms. The pooled effect sizes estimated were an absolute increase of 20% (95% CrI 10%-30%) in HIV testing uptake and an absolute increase of 15% (95% CrI 5%-26%) in consistent condom use. The pooled point estimate of the effect of randomized controlled trials was smaller than that of nonrandomized studies for HIV testing uptake (16% vs 23%) and consistent condom use (10% vs 19%), but their CrIs largely overlapped. Interventions lasting >6 months were associated with a 35% greater uptake of HIV testing (95% CrI 19%-51%) compared to those lasting 6 months. Conclusions: Technology-based HIV prevention interventions are promising strategies to improve HIV testing uptake and consistent condom use among men who have sex with men in China, with significant effects found across a broad array of studies and study designs. However, many studies in this review did not include randomized designs or a control group. More rigorous study designs, such as randomized controlled trials, are needed, with outcome measurements that address the limitation of self-report outcomes to inform the development and implementation of future intervention programs. Trial Registration: PROSPERO CRD42021270856; https://www.crd.york.ac.uk/PROSPERO/view/CRD42021270856 %M 40293786 %R 10.2196/63111 %U https://www.jmir.org/2025/1/e63111 %U https://doi.org/10.2196/63111 %U http://www.ncbi.nlm.nih.gov/pubmed/40293786 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e67507 %T Digital Health Interventions to Prevent Type 2 Diabetes Mellitus: Systematic Review %A Duong,Tuan %A Olsen,Quita %A Menon,Anish %A Woods,Leanna %A Wang,Wenyong %A Varnfield,Marlien %A Jiang,Lee %A Sullivan,Clair %+ Queensland Digital Health Centre, Faculty of Medicine, The University of Queensland, Level 5, UQ Health Sciences Building, Herston Campus Royal Brisbane and Women's Hospital, Brisbane, 4122, Australia, 61 423971469, tuan.duong@uq.edu.au %K digital health %K type 2 diabetes %K prediabetes %K prevent %K digital health intervention %K PRISMA %D 2025 %7 25.4.2025 %9 Review %J J Med Internet Res %G English %X Background: Digital health interventions (DHIs) have rapidly evolved and significantly revolutionized the health care system. The quadruple aims of health care (improving population health, enhancing consumer experience, enhancing health care provider [HCP] experience, and decreasing health costs) serve as a strategic guiding framework for DHIs. It is unknown how DHIs can impact the burden of type 2 diabetes mellitus (T2DM), as measured by the quadruple aims. Objective: This study aimed to systematically review the effects of DHIs on improving the burden of T2DM, as measured by the quadruple aims. Methods: PubMed, Embase, CINAHL, and Web of Science were searched for studies published from January 2014 to March 2024. Primary outcomes were the development of T2DM, hemoglobin A1c (HbA1c) change, and blood glucose change (dysglycemia changes). Secondary outcomes were consumer experience, HCP experience, and health care costs. Outcomes were mapped to the quadruple aims. DHIs were categorized using the World Health Organization’s DHI classification. For each study, DHI categories were assessed for their effects on each outcome, categorizing the effects as positive, negative, or neutral. The overall effects of each DHI category were determined by synthesizing all reported positive, neutral, or negative effects regardless of the number of studies supporting each effect. The Cochrane risk-of-bias version 2 (RoB 2) tool for randomized trials was used to assess the quality of randomized controlled trials (RCTs), while the ROBINS-I (risk of bias in nonrandomized studies of interventions) tool was applied for nonrandomized studies. Results: In total, 53 papers were included. For the T2DM development outcome, the effects of DHIs were positive in 1 (1.9%) study and neutral in 9 (17%) studies, and there were insufficient data to assess in 4 (7.5%) studies. For the dysglycemia outcome, the effects were positive in 23 (43.4%) studies and neutral in 24 (45.3%) studies, and there were insufficient data in 6 (11.3%) studies. There were mixed effects on consumer experience (n=13, 24.5%) and a lack of studies reporting HCP experience (n=1, 1.9%) and health care costs (n=3, 5.7%). All studies that reported positive population health outcomes used a minimum of 2 distinct categories of DHIs. Among these successful studies, the one that reported delaying the development of T2DM and 16 (69.6%) of those reporting improvements in dysglycemia involved HCP interaction. Targeted communication with persons (TCP), personal health tracking (PHT), and telemedicine (TM) showed some evidence as a potentially useful tool for T2DM prevention and dysglycemia. Conclusions: The effects of DHIs on T2DM prevention, as measured by the quadruple aims, have not been comprehensively assessed, with proven benefits for population health, mixed results for consumer experience, and insufficient studies on HCP experience and health care costs. To maximize their effectiveness in preventing T2DM and managing dysglycemia, DHIs should be used in combination and strategically integrated with in-person or remote HCP interaction. Trial Registration: PROSPERO CRD42024512690; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024512690 %M 40280555 %R 10.2196/67507 %U https://www.jmir.org/2025/1/e67507 %U https://doi.org/10.2196/67507 %U http://www.ncbi.nlm.nih.gov/pubmed/40280555 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e65431 %T Exploring the Dynamics of Dietary Self-Monitoring Adherence Among Participants in a Digital Behavioral Weight Loss Program: Model Development Study %A Lin,Hui %A Yang,Min %A Zhou,Zhiheng %A Zhang,Yu %A Deng,Ning %+ Ministry of Education Key Laboratory of Biomedical Engineering, College of Biomedical Engineering and Instrument Science, Zhejiang University, Road 38 West Lake District, Yuquan Campus, Hangzhou, 310000, China, 86 13515816864, zju.dengning@gmail.com %K self-monitoring of dietary behavior %K ACT-R architecture %K digital health interventions %K adherence dynamics %K goal pursuit %K habit formation %K tailored feedback interventions %K weight loss program %K computational behavioral science %D 2025 %7 25.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Self-monitoring of dietary behaviors is typically a central component of behavioral weight loss programs, and it is widely recognized for its effectiveness in promoting healthy behavior changes and improving health outcomes. However, understanding the adherence dynamics of self-monitoring of dietary behaviors remains a challenge. Objective: We aimed to develop a prognostic model for adherence to self-monitoring of dietary behaviors using the Adaptive Control of Thought-Rational (ACT-R) cognitive architecture and to qualitatively investigate adherence dynamics and the impact of various interventions through model-based analyses. Methods: The modeling data were derived from a digital behavioral weight loss program targeting adults who expressed a willingness to improve their lifestyle. Participants were assigned to 1 of 3 intervention groups: self-management, tailored feedback, and intensive support. ACT-R, a cognitive architecture simulating human cognitive processes, was used to model adherence to self-monitoring of dietary behaviors over 21 days, focusing on the mechanisms of goal pursuit and habit formation. Predictor and outcome variables were defined as adjacent elements in the sequence of self-monitoring of dietary behaviors. Model performance was evaluated using mean square error, root mean square error (RMSE), and goodness of fit. Mechanistic contributions were visualized to analyze adherence patterns and the impacts of different interventions. Results: The total sample size for modeling was 97, with 49 in the self-management group, 23 in the tailored feedback group, and 25 in the intensive support group. The ACT-R model effectively captured the adherence trends of self-monitoring of dietary behaviors, with RMSE values of 0.099 for the self-management group, 0.084 for the tailored feedback group, and 0.091 for the intensive support group. The visualized results revealed that, across all groups, the goal pursuit mechanism remained dominant throughout the intervention, whereas the influence of the habit formation mechanism diminished in the later stages. Notably, the presence of tailored feedback and the higher levels of social support were associated with greater goal pursuit and more sustained behavioral practice. Conclusions: This study highlights the potential of ACT-R modeling for dynamic analysis of self-monitoring behaviors in digital interventions. The findings indicate that tailored feedback combined with intensive support may significantly improve adherence. Future studies should (1) extend the intervention duration to explore sustained adherence mechanisms, (2) integrate social cognitive factors to capture behavioral compliance insights, and (3) adapt dynamic models to inform just-in-time adaptive interventions for broader applications. %M 40279647 %R 10.2196/65431 %U https://www.jmir.org/2025/1/e65431 %U https://doi.org/10.2196/65431 %U http://www.ncbi.nlm.nih.gov/pubmed/40279647 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e59085 %T Impact of Computer-Mediated Versus Face-to-Face Motivational-Type Interviews on Participants’ Language and Subsequent Cannabis Use: Randomized Controlled Trial %A Llanes,Karla D %A Amastae,Jon %A Amrhein,Paul C %A Lisha,Nadra %A Arteaga,Katherina %A Lopez,Eugene %A Moran,Roberto A %A Cohn,Lawrence D %+ Center for Tobacco Control Research and Education, University of California San Francisco, 530 Parnassus Ave., Suite 366, San Francisco, CA, 94143, United States, 1 415 476 0140, Karla.llanes@ucsf.edu %K motivational interviews %K computer-mediated %K commitment language %K change talk %K sustain talk %K marijuana use %K cannabis use %K behavior change %K randomized study %K young adults %K marijuana users %K substance use %D 2025 %7 25.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Motivational interviewing (MI) is frequently used to facilitate behavior change. The use of change talk during motivational interviews can predict subsequent behavior change. However, no studies have compared the information obtained from traditional face-to-face motivational interviews and computer-mediated motivational interviews or resulted in the same amount of behavior change. Objective: This study aimed to investigate if face-to-face motivational-type interviews (MTIs) and computer-mediated MTIs elicit the same amount of “change talk” and behavior change when young adults discuss their ambivalence about using marijuana. Methods: A total of 150 users, including frequent marijuana users, occasional marijuana users, and non–marijuana users, participated in the study. All participants reported being at least moderately ambivalent about their current level of marijuana use. Participants were randomly assigned to complete a brief MTI using either the standard face-to-face format or a computer-mediated format. Amrhein’s manual for assessing the presence of “change talk” and “sustain talk” was used to code the language produced by respondents in each interview format. A reduction in marijuana use was assessed at a 2-month follow-up. Results: The word count was significantly higher in face-to-face MTIs compared with computer-mediated MTIs (P<.001). After controlling for verbosity, face-to-face MTIs, and computer-mediated MTIs did not differ statistically in the overall amount of change talk (P=.47) and sustain talk (P=.05). Face-to-face MTIs elicited significantly more reasons for reducing future marijuana use (ie, change talk; P=.02) and readiness toward not using marijuana (ie, change talk; P=.009), even after controlling for verbosity. However, these differences were not statistically significant after using a conservative Bonferroni correction (P<.004). After controlling for marijuana use at Time 1, the relationship between the strength of commitment language at Time 1 and marijuana use at Time 2 was not statistically significant (semipartial correlation r=0.03, P=.57). The association between Time 1 change talk and Time 2 marijuana use depended on the type of motivational interview that participants experienced: face-to-face MTI versus computer-mediated MTI (B=0.45, P=.01). A negative binomial regression with a log link function was used to probe this relationship after controlling for 2 covariates: gender and Time 1 (baseline assessment) marijuana use. Among participants in the face-to-face MTI condition, Time 2 (follow-up) marijuana use decreased as the strength of Time 1 change talk increased, although this finding was not significant (B=–0.21, P=.08). However, among participants in the computer-mediated MTI condition, Time 2 marijuana use was not significantly related to the strength of Time 1 change talk (B=0.13, P=.16). Conclusions: Computer-mediated MTIs and face-to-face MTIs elicit both change talk and sustain talk, which suggests that motivational interviews could potentially be adapted for delivery via text-based computer platforms. However, further research is needed to enhance the predictive validity of the type of language obtained via computer-delivered MI. Trial Registration: ClinicalTrials.gov NCT06945471; https://clinicaltrials.gov/study/NCT06945471 %M 40279644 %R 10.2196/59085 %U https://www.jmir.org/2025/1/e59085 %U https://doi.org/10.2196/59085 %U http://www.ncbi.nlm.nih.gov/pubmed/40279644 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e66037 %T Effect of Digital Exercise Therapy on the Pain and Physical Function of Patients With Osteoarthritis: Systematic Review and Meta-Analysis %A Long,Jing %A You,Jikai %A Yang,Yanan %+ School of Physical Education, Jiangxi Normal University, No. 99 Ziyang Avenue, Nanchang, 330022, China, 86 15201739275, yangyanan_sus@163.com %K exercise program %K telerehabilitation %K rehabilitation %K digital care %K physical activity %K health app %K physical therapy %K systematic review %K meta-analysis %D 2025 %7 25.4.2025 %9 Review %J J Med Internet Res %G English %X Background: Osteoarthritis (OA) is a chronic degenerative bone and joint disease that significantly impacts patients’ quality of life and mental health, while also imposing a substantial economic burden on society. However, access to rehabilitation for patients with OA is challenging upon hospital discharge. Digital exercise therapy represents a promising telemedicine strategy for enhancing the management of OA, but its effect on OA is not yet clear. Objective: This study aimed to systematically evaluate the therapeutic effects of digital exercise therapy on pain and physical function in patients with OA. Methods: Databases including PubMed, Embase, Cochrane Library, Web of Science, and SPORTDiscus were searched for randomized controlled trials on using digital exercise therapy for OA until October 25, 2023. The primary outcomes included the measures of pain scores or physical function scores immediately after the intervention and at full follow-up. The risk of bias was evaluated using the Physiotherapy Evidence Database scale. Relevant data were extracted, and a meta-analysis was performed using RevMan5.3 software (Cochrane Collaboration). Results: A total of 9 studies with 1604 patients were included in the final meta-analysis. Compared with the conventional treatment group, digital exercise therapy significantly reduced numerical rating scale pain scores (mean difference [MD]=–1.07, 95% CI –1.35 to –0.78; P<.001) and Western Ontario and McMaster Universities Osteoarthritis Index physical function scores (MD=–2.39, 95% CI –3.68 to –1.10; P<.001) in patients with OA immediately after the intervention. However, follow-up results revealed no statistically significant difference in numerical rating scale pain scores (MD=–0.20, 95% CI –0.59 to 0.20; P=.34), while Western Ontario and McMaster Universities Osteoarthritis Index physical function scores showed a significant improvement in the digital exercise therapy group compared with the control group (MD=–1.89, 95% CI –3.52 to –0.26; P=.02). These findings suggest that digital exercise therapy provides immediate benefits for both pain and physical function in patients with OA, with sustained improvements in physical function observed during follow-up, though pain relief may not persist long term. Conclusions: Digital exercise therapy can alleviate the pain and improve the physical function in patients with OA and can be used as an auxiliary means in the rehabilitation treatment of OA. It provides great convenience for patients with OA who need long-term treatment, allowing them to exercise at home for rehabilitation training. Trial Registration: PROSPERO CRD42023484819; https://www.crd.york.ac.uk/PROSPERO/view/CRD42023484819 %M 40279572 %R 10.2196/66037 %U https://www.jmir.org/2025/1/e66037 %U https://doi.org/10.2196/66037 %U http://www.ncbi.nlm.nih.gov/pubmed/40279572 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e60676 %T Cardiac Self-Efficacy Improvement in a Digital Heart Health Program: Secondary Analysis From a Feasibility and Acceptability Pilot Study %A Lockwood,Kimberly G %A Kulkarni,Priya R %A Branch,OraLee H %A Graham,Sarah A %K digital health %K self-efficacy %K behavior change %K prevention %K cardiovascular health %K digital heart health %K lifestyle %K heart health %K health coaching %K mobile phone %D 2025 %7 24.4.2025 %9 %J JMIR Form Res %G English %X Background: Lifestyle modification programs play a critical role in preventing and managing cardiovascular disease (CVD). A key aim of many programs is improving patients’ self-efficacy. In-person lifestyle modification programs can enhance self-efficacy in managing CVD risk, also known as cardiac self-efficacy (CSE). However, such programs are typically staffing and resource intensive. Digital lifestyle modification programs may offer a scalable and accessible way to improve CSE, but this has not been shown in prior research. Objective: This study examined changes in CSE among individuals using a digital lifestyle modification program for cardiovascular health. Evaluation of improvement in CSE was a secondary goal of a feasibility and acceptability pilot study of a digital program for Heart Health. Methods: Participants were individuals with elevated risk for CVD who enrolled in a 90-day pilot study that involved mobile app–based, artificial intelligence–powered health coaching and educational lessons focused on behaviors that promote cardiovascular health. Participants completed the 9-item CSE Scale at baseline and in month 2. Changes in confidence in participants’ ability to manage their cardiovascular health were assessed. Results: The sample included 273 (n=207, 61.2% female; mean age 59.3, SD 10.1 years) participants who submitted a complete CSE Scale at baseline and in month 2. The total CSE Scale score increased by 12.9% (P<.001) from baseline to month 2. Additionally, there were significant increases in mean score on each of the 9 individual CSE Scale items (all P<.001), with the largest increases in confidence “in knowing when to call or visit the doctor for your heart disease” (17% increase; P<.001), “in knowing how much physical activity is good for you” (16.3% increase; P<.001), and “that you can get regular aerobic exercise” (19% increase; P<.001). Conclusions: The present analyses indicate that participants in a digital lifestyle modification program for cardiovascular health showed significant improvements in CSE within 2 months. This work adds to the growing literature examining ways to improve health-related self-efficacy and scalable access to programs for prevention and management of CVD. %R 10.2196/60676 %U https://formative.jmir.org/2025/1/e60676 %U https://doi.org/10.2196/60676 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e60957 %T Blended Mobile-Based Interventions With Integrated Virtual Reality Exposure Therapy for Anxiety Disorders: Thematic Analysis of Patient Perspectives %A Planert,Jari %A Hildebrand,Anne-Sophie %A Machulska,Alla %A Roesmann,Kati %A Neubert,Marie %A Pilgramm,Sebastian %A Pilgramm,Juliane %A Klucken,Tim %+ Department of Psychology, Clinical Psychology and Psychotherapy, University of Siegen, Obergraben 21, Siegen, 57072, Germany, 49 271 740 ext 3887, jari.planert@uni-siegen.de %K virtual reality exposure therapy %K anxiety disorders %K internet- and mobile-based interventions %K blended therapy %K eHealth %D 2025 %7 24.4.2025 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Guided mobile-based interventions may mitigate symptoms of anxiety disorders such as panic disorder, agoraphobia, or social anxiety disorder. With exposure therapy being efficacious in traditional treatments for these disorders, recent advancements have introduced 360° videos to deliver virtual reality exposure therapy (VRET) within mobile-based interventions. Objective: Despite ongoing trials evaluating the treatment’s efficacy, research examining patient perceptions of this innovative approach is still scarce. Therefore, this study aimed to explore patient opinions on specific treatment aspects of mobile-based interventions using mobile VRET and psychotherapeutic guidance for anxiety disorders. Methods: A total of 11 patients diagnosed with panic disorder, agoraphobia, or social anxiety disorder who had previously taken part in the experimental conditions of 2 randomized controlled trials for a mobile intervention including mobile VRET participated in cross-sectional, retrospective interviews. Using a semistructured interview format, patients were asked to reflect on their treatment experiences; personal changes; helpful and hindering aspects; their motivation levels; and their encounters with the mobile-based intervention, manualized treatment sessions, and the mobile VRET. Results: Thematic analysis led to the formation of 14 themes in four superordinate categories: (1) perceived treatment outcomes, (2) aspects of the mobile intervention, (3) experiences with mobile VRET, and (4) contextual considerations. Patients offered their insights into factors contributing to treatment success or failure, delineated perceived treatment outcomes, and highlighted favorable aspects of the treatment while pointing out shortcomings and suggesting potential enhancements. Most strikingly, while using a blended app-based intervention, patients highlighted the role of psychotherapeutic guidance as a central contributing factor to their symptom improvement. Conclusions: The findings of the thematic analysis and its diverse patient perspectives hold the potential to guide future research to improve mobile-based treatment options for anxiety disorders. Insights from these patient experiences can contribute to refining mobile-based interventions and optimizing the integration of VRET in accordance with patients’ preferences, needs, and expectations. %M 40273440 %R 10.2196/60957 %U https://humanfactors.jmir.org/2025/1/e60957 %U https://doi.org/10.2196/60957 %U http://www.ncbi.nlm.nih.gov/pubmed/40273440 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e71867 %T Feasibility Testing a Meditation App for Professionals Working With Youth in the Legal System: Protocol for a Hybrid Type 2 Effectiveness-Implementation Pilot Randomized Controlled Trial %A Kendall,Ashley D %A Pela,Emily %A Amonica,Danielle %A Jaworski,Erin %A Floyd,Brenikki %A , %+ Center for Dissemination and Implementation Science, Department of Medicine, University of Illinois Chicago, 818 S. Wolcott Ave., SRH 6th Floor, Chicago, IL, 60612, United States, 1 3123551836, akendall@uic.edu %K mobile app %K mHealth %K digital mental health %K meditation %K mindfulness %K juvenile legal system %K officers %K workplace %K ecological momentary assessment (EMA) %K emotion regulation %D 2025 %7 24.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Probation officers and other professionals who work with youth in the legal system often experience high chronic workplace stress, which can contribute over time to elevations in anxiety, depression, and workplace burnout. Emotion dysregulation appears to function as a common mechanism underlying these elevations, and growing evidence suggests it can be improved with mindfulness meditation. Implemented successfully, app-based meditation programs could provide professionals with real-time tools for mitigating the effects of chronic workplace stress. Objective: This paper describes the protocol for a hybrid type 2 effectiveness-implementation pilot randomized controlled trial (RCT) of Bodhi AIM+, a meditation app adapted with and for professionals who work with youth in the legal system. The adaptation process and implementation plan, as well as the pilot RCT design, were guided by theoretically driven implementation science frameworks. The primary outcome of the pilot RCT is app adherence (ie, ongoing app usage per objective analytics data). Methods: The RCT will be fully remote. Officers and other professionals who work with youth in the legal system (N=50) will be individually randomized to use the meditation app or an active control app matched for time and structure. All participants will be asked to follow a 30-day path of brief audio- or video-guided content and invited to use additional app features as desired. In-app analytics will capture the objective usage of each feature. An adaptive engagement design will be employed to engage nonusers of both apps, whereby analytics data indicating nonuse will trigger additional support (eg, text messages promoting engagement). Mental health outcomes and potential moderators and covariates will be self-reported at baseline, posttest, and 6 months. Participants will also complete 1-week bursts of ecological momentary assessment (EMA) at baseline and over the last week of the intervention to capture the mechanistic target (ie, emotion regulation) in real time. All participants will be invited to complete qualitative posttest interviews. Descriptive statistics will be calculated for quantitative data. Qualitative data will be analyzed using a combined deductive-inductive approach. The quantitative and qualitative data will be incorporated into a mixed methods triangulation design, allowing for the evaluation of app adherence and other implementation outcomes as well as related barriers and facilitators to implementation. Results: Enrollment into the trial started in December 2024 and is currently underway. Study results are anticipated to be available in 2026. Conclusions: Completion of this pilot trial will inform a future, fully powered RCT to formally evaluate the effectiveness and implementation of Bodhi AIM+. Its use of implementation science methods, coupled with digital technology, positions the present study not only to help make meditation tools available to an important workforce at scale but also to inform broader efforts at implementing and evaluating health apps within workplace settings. Trial Registration: ClincialTrials.gov NCT06555172; https://clinicaltrials.gov/study/NCT06555172 International Registered Report Identifier (IRRID): DERR1-10.2196/71867 %M 40273446 %R 10.2196/71867 %U https://www.researchprotocols.org/2025/1/e71867 %U https://doi.org/10.2196/71867 %U http://www.ncbi.nlm.nih.gov/pubmed/40273446 %0 Journal Article %@ 2369-3762 %I JMIR Publications %V 11 %N %P e45912 %T Effectiveness of an Interactive Web-Based Clinical Practice Monitoring System on Enhancing Motivation in Clinical Learning Among Undergraduate Nursing Students: Longitudinal Quasi-Experimental Study in Tanzania %A Herman,Patricia %A M Kibusi,Stephen %A C Millanzi,Walter %+ Department of Nursing, College of Health and Allied Sciences, Ruaha Catholic University, Box 774, Iringa, United Republic of Tanzania, 255 788315184, patriciaz1006@gmail.com %K clinical monitoring system %K clinical practice %K motivation in clinical learning %K nursing students %K smartphone %K mobile phone %K Ruaha Catholic University %K web-based teaching %D 2025 %7 23.4.2025 %9 Original Paper %J JMIR Med Educ %G English %X Background: Nursing students’ motivation in clinical learning is very important not only for their academic and professional achievement but also for making timely, informed, and appropriate decisions in providing quality and cost-effective care to people. However, the increased number of students and the scarcity of medical supplies, equipment, and patients, just to mention a few, have posed a challenge to educators in identifying and navigating the best approaches to motivate nursing students to learn during their clinical placements. Objective: This study primarily used descriptive and analytical methods to examine undergraduate nursing students’ desire for clinical learning both before and after participating in the program. Methods: An uncontrolled longitudinal quasi-experimental study in a quantitative research approach was conducted from February to March 2021 among 589 undergraduate nursing students in Tanzania. Following a baseline evaluation, nursing students were enrolled in an interactive web-based clinical practice monitoring system by their program, institution, names, registration numbers, and emails via unique codes created by the lead investigator and trainers. The system recorded and generated feedback on attendance, clinical placement unit, selected or performed clinical nursing procedures, and in-between and end-of-shift feedback. The linear regression was used to assess the effect of the intervention (interactive web-based clinical practice monitoring system) controlled for other correlated factors on motivation in clinical learning (outcome) among nursing students. Nursing students’ sociodemographic characteristics and levels of motivation in clinical learning were analyzed descriptively while a 2-tailed paired sample t test established a comparative mean difference in motivation in clinical learning between the pretest and the posttest. The association between variables was determined using regression analysis set at a 95% CI and 5% statistical significance. Results: The mean age of study participants (N=589) was 23 (SD 2.69) years of which 383 (65.0%) were male. The estimated effect (β) of a 3-week intervention to improve nursing students’ motivation in clinical learning was 3.041 (P=.03, 95% CI 1.022-7.732) when controlled for other co-related factors. The mean score for motivation in clinical learning increased significantly from the baseline (mean 9.31, SD 2.315) to the postintervention (mean 20.87, SD 5.504), and this improvement presented a large effect size of 2.743 (P<.001, 95% CI 1.011-4.107). Conclusions: Findings suggest that an interactive web-based clinical practice monitoring system is viable and has the potential to improve undergraduate nursing students’ motivation for clinical learning. One alternative clinical pedagogy that educators in nursing education can use to facilitate clinical learning activities and develop motivated undergraduate nursing students is the integration of such technology throughout nursing curricula. %M 40267464 %R 10.2196/45912 %U https://mededu.jmir.org/2025/1/e45912 %U https://doi.org/10.2196/45912 %U http://www.ncbi.nlm.nih.gov/pubmed/40267464 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 13 %N %P e68665 %T Assessment of an App-Based Sleep Program to Improve Sleep Outcomes in a Clinical Insomnia Population: Randomized Controlled Trial %A Staiano,Walter %A Callahan,Christine %A Davis,Michelle %A Tanner,Leah %A Coe,Chelsea %A Kunkle,Sarah %A Kirk,Ulrich %+ Department of Psychology, University of Southern Denmark, Campusvej 55, Odense, 5230, Denmark, 45 65502695, ukirk@health.sdu.dk %K cognitive behavioral therapy for insomnia %K mindfulness %K randomized controlled trial %K RCT %K therapy %K insomnia %K behavioral %K app based %K app %D 2025 %7 23.4.2025 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Insomnia is the most commonly reported sleep disturbance and significantly impacts mental health and quality of life. Traditional treatments for insomnia include pharmacological interventions or cognitive behavioral therapy for insomnia (CBT-I), but these options may not be accessible to everyone who needs treatment. Objective: This study aims to assess the effectiveness of the app-based Headspace Sleep Program in adults with clinical insomnia on sleep disturbance and mental health outcomes, compared with a waitlist control group. Methods: This randomized controlled trial included 132 adults with clinical insomnia who were assigned to either the Headspace Sleep Program (an 18-session self-guided, in-app program utilizing CBT-I techniques augmented by mindfulness) or a waitlist control group. Sleep disturbance outcomes were assessed by changes in insomnia symptoms (measured using the Insomnia Severity Index) and sleep efficiency (measured via sleep diary and actigraphy). Mental health outcomes included perceived stress (measured by the 10-item Perceived Stress Scale), depressive symptoms (measured by the 8-item Patient Health Questionnaire), sleep quality (measured by the Pittsburgh Sleep Quality Index), anxiety symptoms (measured by the 7-item Generalized Anxiety Disorder Scale), and mindfulness (measured by the Mindful Attention Awareness Scale). Changes from baseline to postintervention and follow-up were assessed for each outcome. Results: Participants had a mean (SD) age of 37.2 (10.6) years, with 69 out of 132 (52.3%) identifying as female. Those randomized to the Headspace Sleep Program group experienced significantly greater improvements in insomnia symptoms from baseline to postintervention and follow-up compared with participants in the waitlist control group (P<.001, η²p=0.107). Improvements from baseline to postintervention and follow-up were also observed in the Headspace Sleep Program group for sleep efficiency, as measured by both sleep diary (P=.01, η²p=.03) and actigraphy outcomes (P=.01, η²p=.03). Participants in the Headspace Sleep Program group showed greater improvements in insomnia remission rates (8/66, 12%, at postintervention and 9/66, 14%, at follow-up) and treatment response (11/66, 17%, at postintervention and 15/66, 23%, at follow-up) compared with the control group (remission rate 2/66, 3%, at postintervention and 0/66, 0%, at follow-up; treatment response 3/66, 5%, at postintervention and 1/66, 2%, at follow-up). The results suggest significant improvements in depressive symptoms (P=.01, η²p=.04), anxiety symptoms (P=.02, η²p=.02), and mindfulness (P=.01, η²p=.03) in the Headspace Sleep Program group. Conclusions: The Headspace Sleep Program is an effective intervention for improving sleep disturbances in adults with clinical insomnia. Trial Registration: ClinicalTrials.gov NCT05872672; https://clinicaltrials.gov/ct2/show/NCT05872672 %M 40267472 %R 10.2196/68665 %U https://mhealth.jmir.org/2025/1/e68665 %U https://doi.org/10.2196/68665 %U http://www.ncbi.nlm.nih.gov/pubmed/40267472 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 10 %N %P e56934 %T mHealth Social Support Versus Standard Support for Diabetes Management in Safety-Net Emergency Department Patients: Randomized Phase-III Trial %A Burner,Elizabeth %A Hazime,Danielle %A Menchine,Michael %A Mack,Wendy %A Mercado,Janisse %A Aleman,Adriana %A Hernandez Saenz,Antonio %A Arora,Sanjay %A Wu,Shinyi %+ Department of Emergency Medicine, Keck School of Medicine, University of Southern California, 1200 North State St, Department of Emergency Medicine, Room 1011, Los Angeles, CA, 92124, United States, 1 3234096667, eburner@usc.edu %K social support %K mobile health %K mHealth %K SMS text messaging %K diabetes self-management %D 2025 %7 23.4.2025 %9 Original Paper %J JMIR Diabetes %G English %X Background: Mobile health (mHealth) is a low-cost method to improve health for patients with diabetes seeking care in safety-net emergency departments, resulting in improved medication adherence and self-management. Additions of social support to mHealth interventions could further enhance diabetes self-management by increasing the gains and the postintervention maintenance. Objective: We assessed outcomes of an unblinded, parallel, equal-allocation randomized phase-III trial that tested a social support mHealth intervention to improve emergency department patients’ diabetes self-management. Methods: Patients with glycated hemoglobin (HbA1c) levels of ≥8.5% mg/dL and a text-capable phone were recruited during their emergency department visit for any reason (diabetes related or not) at a US public hospital along with a friend or family member as a supporter. Patients received 6 months of the Trial to Examine Text Messaging in Emergency Department Patients With Diabetes self-management mHealth program. Supporters were randomized to receive either (1) an mHealth social support program (Family and Friends Network Support)—daily SMS text messages guiding supporters to provide diabetes-related social support—or (2) a non-mHealth social support program as an active control—pamphlet-augmented social support with Family and Friends Network Support content. Point-of-care HbA1c level, self-reported diabetes self-care activities, medication adherence, and safety events were collected. Mixed-effects linear regression models analyzed group differences at the end of the intervention (6 months) and the postintervention phase (12 months) for HbA1c level and behavioral outcomes. Results: A total of 166 patients were randomized. In total, 8.4% (n=14) reported type 1 diabetes, 66.9% (n=111) reported type 2 diabetes, and 24.7% (n=41) did not know their diabetes type; 50% (n=83) reported using insulin for diabetes management. Trial follow-up was completed with 58.4% (n=97) of the patients at 6 months and 63.9% (n=106) of the patients at 12 months. Both groups showed significant HbA1c level improvements (combined group change=1.36%, SD 2.42% mg/dL; 95% CI 0.87-1.83; P<.001), with no group difference (group mean difference=0.14%, SD 4.88% mg/dL; 95% CI −1.11 to 0.83; P=.87) at 6 months. At 12 months, both groups maintained their improved HbA1c levels, with a combined mean change from 6 months of 0.06% (SD 1.89% mg/dL; 95% CI −0.34 to 0.47; P=.76) and no clinically meaningful difference between groups. No differences were observed in safety events. In subgroup analyses, patients recently diagnosed with diabetes in the mHealth social support group improved their glycemic control compared to the standard social support group (between-group difference of 1.96%, SD 9.59% mg/dL; 95% CI −3.81 to −0.125; P=.04). Conclusions: A 6-month change in HbA1c level did not differ by mode of social support in persons using an existing patient-focused mHealth diabetes self-management program, but both groups improved in self-management and glycemic control. Newly diagnosed patients with diabetes benefited most from mHealth-augmented social support. Trial Registration: ClinicalTrials.gov NCT03178773; https://clinicaltrials.gov/study/NCT03178773 International Registered Report Identifier (IRRID): RR2-10.1016/j.cct.2019.03.003 %M 40266665 %R 10.2196/56934 %U https://diabetes.jmir.org/2025/1/e56934 %U https://doi.org/10.2196/56934 %U http://www.ncbi.nlm.nih.gov/pubmed/40266665 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e69425 %T Effectiveness of a Mobile Phone-Delivered Multiple Health Behavior Change Intervention (LIFE4YOUth) in Adolescents: Randomized Controlled Trial %A Seiterö,Anna %A Henriksson,Pontus %A Thomas,Kristin %A Henriksson,Hanna %A Löf,Marie %A Bendtsen,Marcus %A Müssener,Ulrika %+ Department of Health, Medicine and Caring Sciences, Linköping University, Campus US, Linköping, SE-58183, Sweden, 46 700895376, anna.seitero@liu.se %K mHealth %K multiple behavior %K high school students %K digital behavior change intervention %K public health %K telemedicine %K randomized controlled trial %D 2025 %7 22.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Although mobile health (mHealth) interventions have demonstrated effectiveness in modifying 1 or 2 health-risk behaviors at a time, there is a knowledge gap regarding the effects of stand-alone mHealth interventions on multiple health risk behaviors. Objective: This study aimed to estimate the 2- and 4-month effectiveness of an mHealth intervention (LIFE4YOUth) targeting alcohol consumption, diet, physical activity, and smoking among Swedish high school students, compared with a waiting-list control condition. Methods: A 2-arm parallel group, single-blind randomized controlled trial (1:1) was conducted from September 2020 to June 2023. Eligibility criteria included nonadherence to guidelines related to the primary outcomes, such as weekly alcohol consumption (standard drinks), monthly frequency of heavy episodic drinking (ie, ≥4 standard drinks), daily intake of fruit and vegetables (100-g portions), weekly consumption of sugary drinks (33-cL servings), weekly duration of moderate to vigorous physical activity (minutes), and 4-week point prevalence of smoking abstinence. The intervention group had 16 weeks of access to LIFE4YOUth, a fully automated intervention including recurring screening, text message services, and a web-based dashboard. Intention-to-treat analysis was conducted on available and imputed 2- and 4-month self-reported data from participants at risk for each outcome respectively, at baseline. Effects were estimated using multilevel models with adaptive intercepts (per individual) and time by group interactions, adjusted for baseline age, sex, household economy, and self-perceived importance, confidence, and know-how to change behaviors. Bayesian inference with standard (half-)normal priors and null-hypothesis testing was used to estimate the parameters of statistical models. Results: In total, 756 students (aged 15-20, mean 17.1, SD 1.2 years; 69%, 520/756 females; 31%, 236/756 males) from high schools across Sweden participated in the trial. Follow-up surveys were completed by 71% (539/756) of participants at 2 months and 57% (431/756) of participants at 4 months. Most participants in the intervention group (219/377, 58%) engaged with the intervention at least once. At 2 months, results indicated positive effects in the intervention group, with complete case data indicating median between-group differences in fruit and vegetable consumption (0.32 portions per day, 95% CI 0.13-0.52), physical activity (50 minutes per week, 95% CI –0.2 to 99.7), and incidence rate ratio for heavy episodic drinking (0.77, 95% CI 0.55-1.07). The odds ratio for smoking abstinence (1.09, 95% CI 0.34-3.64), incidence rate ratio for weekly alcohol consumption (0.69, 95% CI 0.27-1.83), and the number of sugary drinks consumed weekly (0.89, 95% CI 0.73-1.1) indicated inconclusive evidence for effects due to uncertainty in the estimates. At 4 months, a remaining effect was observed on physical activity only. Conclusions: Although underpowered, our findings suggest modest short-term effects of the LIFE4YOUth intervention, primarily on physical activity and fruit and vegetable consumption. Our results provide inconclusive evidence regarding weekly alcohol consumption and smoking abstinence. Trial Registration: ISRCTN Registry ISRCTN34468623; https://doi.org/10.1186/ISRCTN34468623 %M 40262133 %R 10.2196/69425 %U https://www.jmir.org/2025/1/e69425 %U https://doi.org/10.2196/69425 %U http://www.ncbi.nlm.nih.gov/pubmed/40262133 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e71684 %T Effectiveness of an Innovative Mobile-Based Perioperative Care Program for Women Undergoing Breast Cancer Surgery (iCareBreast): Randomized Controlled Trial %A Pang,Yan %A He,Honggu %A Ng,Ruey-Pyng %A Lee,Nicole Kim Luan %A Htein,Me Me Win %A Zhao,Xiao-Xin %A Li,Ying-Hong %A Chan,Elizabeth Jiahui %A Zhu,Lixia %A Liu,Guang Yu %A Pikkarainen,Minna %A Lim,Swee-Ho %+ Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 5, Centre for Translational Medicine, Block MD6, 14 Medical Drive, Singapore, 117599, Singapore, 65 65167448, nurhhg@nus.edu.sg %K breast cancer %K digital health %K mHealth %K mobile health %K psychosocial %K randomized controlled trial %K self-efficacy %K mobile phone %D 2025 %7 21.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Breast cancer is one of the most prevalent cancers among women and significantly impacts psychological well-being and health-related quality of life (HR-QoL) during the perioperative period. Mobile health interventions offer a promising approach to providing education and psychosocial support, yet their effectiveness in this context remains underexplored. Objective: This study aimed to develop and evaluate the effectiveness of an innovative, mobile-based, perioperative care program for women undergoing breast cancer surgery (iCareBreast). The assessment focused on perioperative self-efficacy, anxiety, depression, fatigue, HR-QoL, and perioperative care satisfaction. Methods: A two-group randomized control trial was conducted at a tertiary hospital in Singapore. The intervention group used the iCareBreast app, offering four main resources: perioperative care guidance, breast cancer and surgery education, psychological support, and social support. The control group received standard hospital care. Participants in the intervention group engaged with the fully automated app daily for 29 days (two weeks before surgery, on the day of surgery, and two weeks after surgery). Data were collected face-to-face or on the web at three time points: baseline, immediately after the intervention (T1; two weeks after surgery), and at a 2.5-month follow-up (T2; three months after surgery). The primary outcome was perioperative care self-efficacy, while secondary outcomes included anxiety, depression, fatigue, HR-QoL, and perioperative care satisfaction. Results: A total of 123 patients with early-stage breast cancer scheduled for breast surgery were enrolled in the study, with 62 patients assigned to the iCareBreast group and 61 patients to the control group. The results showed no significant differences between the groups in the primary outcome—perioperative self-efficacy—at any time point. Baseline scores were similar (P=.80), and while the iCareBreast group showed slightly lower scores at T1 (mean difference [MD] –1.63, 95% CI –3.43 to 0.18; P=.08) and T2 (MD –1.90, 95% CI –4.06 to 0.26; P=.09), the differences were not statistically significant. Similarly, secondary outcomes, including anxiety, depression, fatigue, HR-QoL, and perioperative care satisfaction, showed no significant changes between groups (all P>.05). However, the iCareBreast group reported higher perioperative care satisfaction during the postintervention assessment. Satisfaction scores were comparable at T1 (P=.68), while at T2, the iCareBreast group showed a slight increase compared to the control group (MD 0.35, 95% CI 0.04-0.73; P=.08), though the difference was not statistically significant. Conclusions: The mobile-based psychosocial intervention, although satisfied by users, did not demonstrate significant benefits compared to standard care. This highlights the need to refine the iCareBreast app in future iterations to enhance its effectiveness in addressing the targeted health outcomes. Future mobile health research should prioritize optimizing user engagement strategies and incorporating personalized approaches to better address the perioperative care needs of patients with breast cancer. Trial Registration: ClinicalTrials.gov NCT04172350; https://clinicaltrials.gov/study/NCT04172350 %M 40258266 %R 10.2196/71684 %U https://www.jmir.org/2025/1/e71684 %U https://doi.org/10.2196/71684 %U http://www.ncbi.nlm.nih.gov/pubmed/40258266 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e60681 %T A WeChat-Based Decision Aid Intervention to Promote Informed Decision-Making for Family Members Regarding the Genetic Testing of Patients With Colorectal Cancer: Randomized Controlled Trial %A Li,Huanhuan %A Zhao,Yanjie %A Li,Wei %A Wang,Wenxia %A Zhi,Shengze %A Wu,Yifan %A Zhong,Qiqing %A Wang,Rui %A Sun,Jiao %+ , School of Nursing, Jilin University, Number 965, Xinjiang Street, Changchun, Jilin, 130021, China, 86 13844879177, sunjiao@jlu.edu.cn %K decision aid %K genetic testing %K hereditary colorectal cancer %K informed decision-making %K RCT %K WeChat based %D 2025 %7 21.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Identifying patients with inherited colorectal cancer (CRC) syndromes offers many potential benefits. However, individuals often experience decisional conflict regarding genetic testing for CRC, and the uptake rate remains low. Given the growing popularity of genetic testing and the increasing demands on genetic service providers, strategies are needed to promote informed decision-making, increase genetic testing uptake among at-risk individuals, and ensure the rational use of genetic service resources. Objective: This study aims to determine whether a decision aid (DA) tool could promote informed decision-making among family members regarding the genetic testing of a patient with CRC. Methods: A single-center, parallel-group, randomized controlled trial was conducted. We randomized 82 family members of patients with CRC, who were involved in major medical decision-making for the patient, to either a DA intervention or usual care. The primary outcome was informed decision-making, assessed through measures of knowledge, decisional conflict, decision self-efficacy, and preparation for decision-making. Secondary outcomes included patients’ uptake of genetic counseling and testing, participants’ CRC screening behavior, healthy lifestyle scores, anxiety and depression levels, quality of life, and satisfaction with the intervention. Data were collected at baseline (T0), after the intervention (T1), and 3 months after the baseline survey (T2). The DA intervention and outcome assessments at T1 and T2 were delivered via WeChat. The effects of the intervention were analyzed using generalized estimating equation models. Results: Statistically significant improvements were observed in knowledge (T1: β=2.049, P<.001; T2: β=3.317, P<.001), decisional conflict (T1: β=–11.660, P<.001; T2: β=–17.587, P<.001), and decision self-efficacy (T1: β=15.353, P<.001; T2: β=22.337, P<.001) in the DA group compared with the usual care group at both T1 and T2. Additionally, the DA group showed significantly greater improvement in processed and red meat intake (β=–1.494, P<.001) at T1 and in healthy lifestyle scores (β=1.073, P=.03) at T2. No differences were found between the groups for other outcomes. Conclusions: A DA tool may be a safe, effective, and resource-efficient approach to facilitate informed decision-making about genetic testing. However, the current DA tool requires optimization and further evaluation—for example, by leveraging more advanced technology than WeChat to develop a simpler and more intelligent DA system. Trial Registration: Chinese Clinical Trial Registry ChiCTR2100048051; https://www.chictr.org.cn/showproj.html?proj=129054 %M 40258273 %R 10.2196/60681 %U https://www.jmir.org/2025/1/e60681 %U https://doi.org/10.2196/60681 %U http://www.ncbi.nlm.nih.gov/pubmed/40258273 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 10 %N %P e53854 %T Exploring Psychosocial Burdens of Diabetes in Pregnancy and the Feasibility of Technology-Based Support: Qualitative Study %A Roytman,Maya V %A Lu,Layna %A Soyemi,Elizabeth %A Leziak,Karolina %A Niznik,Charlotte M %A Yee,Lynn M %+ Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, 250 E. Superior Street, Chicago, IL, 60611, United States, 1 312 472 4685, lynn.yee@northwestern.edu %K digital health %K mHealth %K pregnancy %K psychosocial %K social determinants %K technology %K diabetes %K burdens %K qualitative analysis %K mobile apps %K feasibility %D 2025 %7 21.4.2025 %9 Original Paper %J JMIR Diabetes %G English %X Background: Gestational diabetes mellitus and type 2 diabetes mellitus impose psychosocial burdens on pregnant individuals. As there is less evidence about the experience and management of psychosocial burdens of diabetes mellitus during pregnancy, we sought to identify these psychosocial burdens and understand how a novel smartphone app may alleviate them. The app was designed to provide supportive, educational, motivational, and logistical support content, delivered through interactive messages. Objective: The study aimed to analyze the qualitative data generated in a feasibility randomized controlled trial of a novel mobile app designed to promote self-management skills, motivate healthy behaviors, and inform low-income pregnant individuals with diabetes. Methods: Individuals receiving routine clinical care at a single, large academic medical center in Chicago, Illinois were randomized to use of the SweetMama app (n=30) or usual care (n=10) from diagnosis of diabetes until 6 weeks post partum. All individuals completed exit interviews at delivery about their experience of having diabetes during pregnancy. Interviews were guided by a semistructured interview guide and were conducted by a single interviewer extensively trained in empathic, culturally sensitive qualitative interviewing of pregnant and postpartum people. SweetMama users were also queried about their perspectives on the app. Interview data were audio-recorded and professionally transcribed. Data were analyzed by 2 researchers independently using grounded theory constant comparative techniques. Results: Of the 40 participants, the majority had gestational diabetes mellitus (n=25, 63%), publicly funded prenatal care (n=33, 83%), and identified as non-Hispanic Black (n=25, 63%) or Hispanic (n=14, 35%). Participants identified multiple psychosocial burdens, including challenges taking action, negative affectivity regarding diagnosis, diet guilt, difficulties managing other responsibilities, and reluctance to use insulin. External factors, such as taking care of children or navigating the COVID-19 pandemic, affected participant self-perception and motivation to adhere to clinical recommendations. SweetMama participants largely agreed that the use of the app helped mitigate these burdens by enhancing self-efficacy, capitalizing on external motivation, validating efforts, maintaining medical nutrition therapy, extending clinical care, and building a sense of community. Participants expressed that SweetMama supported the goals they established with their clinical team and helped them harness motivating factors for self-care. Conclusions: Psychosocial burdens of diabetes during pregnancy present challenges with diabetes self-management. Mobile health support may be an effective tool to provide motivation, behavioral cues, and access to educational and social network resources to alleviate psychosocial burdens during pregnancy. Future incorporation of machine learning and language processing models in the app may provide further personalization of recommendations and education for individuals with DM during pregnancy. Trial Registration: ClinicalTrials.gov NCT03240874; https://clinicaltrials.gov/study/NCT03240874 %M 40258264 %R 10.2196/53854 %U https://diabetes.jmir.org/2025/1/e53854 %U https://doi.org/10.2196/53854 %U http://www.ncbi.nlm.nih.gov/pubmed/40258264 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e67950 %T Efficacy of an Intelligent and Integrated Older Adult Care Model on Quality of Life Among Home-Dwelling Older Adults: Randomized Controlled Trial %A Guo,Rongrong %A Zhang,Jiwen %A Yang,Fangyu %A Wu,Ying %+ School of Nursing, Capital Medical University, 10 You-an-men Wai Xi-tou-tiao, Feng-tai District, Beijing, 100069, China, 86 13910789837, helenywu@vip.163.com %K efficacy %K home care %K integrated care %K intelligent %K elderly people %K quality of life %K mobile phone %D 2025 %7 21.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Integrated care models enhanced by the clinical decision support system offer innovative approaches to managing the growing global burden of older adult care. However, their efficacy remains uncertain. Objective: This study aimed to evaluate the efficacy of an intelligent and integrated older adult care model, termed the SMART (Sensors and scales [receptor], a Mobile phone autonomous response system [central nervous system in the spinal cord], a Remote cloud management center [central nervous system in the brain], and a Total care system [effector]) system, in improving the quality of life (QOL) for home-dwelling older adults. Methods: In this stratified randomized controlled trial, we consecutively recruited older adults aged 65 years or older from November 1, 2020, to December 31, 2020. Eligible participants were randomly allocated 1:1 to either the SMART group, receiving routine discharge instructions and personalized integrated care interventions across 11 domains (decreased or lost self-care ability, falls, delirium, dysphagia, incontinence, constipation, urinary retention, cognitive decline, depression, impaired skin integrity, and common diseases) generated by the SMART system, or the usual care group, receiving only routine discharge instructions. The intervention lasted for 3 months. The primary end point was the percent change in QOL from baseline to the 3-month follow-up, assessed using the World Health Organization Quality of Life Instrument - Older Adults Module. Secondary end points included functional status at the 3-month follow-up and percent changes in health self-management ability, social support, and confidence in avoiding falling from baseline to the 3-month follow-up. Data were analyzed following the intention-to-treat principle, using covariance or logistic regression models, as appropriate. Subgroup and sensitivity analyses were conducted to assess result consistency and robustness. Results: In total, 94 participants were recruited, with 48 assigned to the SMART group. The personalized and integrated care by the SMART system significantly improved the QOL among the older adults, with an estimated intervention difference of 11.97% (95% CI 7.2%-16.74%, P<.001), and social support and health self-management ability as well, with estimated intervention differences of 6.75% (95% CI 3.19%-10.3%, P<.001) and 4.95% (95% CI 0.11%-10%, P=.003), respectively, while insignificantly improving in the Modified Falls Efficacy Scale score. Similarly, the SMART system had a 66% reduction in instrumental activities of daily living disability (odds ratio [OR] 0.34, 95% CI 0.11-0.83, P=.02). However, the SMART system did not significantly affect activities of daily living disability or the Modified Falls Efficacy Scale score. The subgroup and sensitivity analyses confirmed the robustness of the findings. Conclusions: The personalized and integrated older adult care by the SMART system demonstrated significant efficacy in improving QOL, health self-management ability, and social support, while reducing instrumental activities of daily living disability among home-dwelling older adults. Trial Registration: Chinese Clinical Trial Registry ChiCTR-IOR-17010368; https://tinyurl.com/2zax24xr %M 40258267 %R 10.2196/67950 %U https://www.jmir.org/2025/1/e67950 %U https://doi.org/10.2196/67950 %U http://www.ncbi.nlm.nih.gov/pubmed/40258267 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e71057 %T Effects of an e-Learning Program (Physiotherapy Exercise and Physical Activity for Knee Osteoarthritis [PEAK]) on Chinese Physical Therapists’ Confidence and Knowledge: Randomized Controlled Trial %A Wang,Zi-Ru %A Wang,Yunqi %A Duan,Shuning %A Chen,Xier %A Ni,Guoxin %+ Department of Rehabilitation Medicine, School of Medicine, Xiamen University, First Affiliated Hospital of Xiamen University, No. 55 Zhenhai Road, Siming District, Xiamen, 361003, China, 86 5922137084, nigx@xmu.edu.cn %K osteoarthritis %K telehealth %K exercise therapy %K e-learning %K physiotherapist %K Knee Osteoarthritis Knowledge Scale %D 2025 %7 18.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Knee osteoarthritis (OA) presents a significant burden in China due to its high prevalence, aging population, and rising obesity rates. Despite clinical guidelines recommending evidence-based care, limited practitioner training and inadequate telehealth integration hinder effective OA management. Objective: The aim of this study was to evaluate the effectiveness of an e-learning program in improving the confidence and knowledge of Chinese physical therapists in managing knee OA and to explore their perceptions of the program. Methods: This was a randomized controlled trial with 2 parallel arms involving 81 rehabilitation practitioners from 18 Chinese provinces. The intervention group completed a 4-week web-based training program (Physiotherapy Exercise and Physical Activity for Knee Osteoarthritis [PEAK]-Chinese), while the control group received no training. The primary outcome was self-reported confidence in OA management (11-point scale). Secondary outcomes included knowledge (Chinese Knee Osteoarthritis Knowledge Scale [KOAKS]) and likelihood of clinical application of core OA treatments. Process measures and semistructured interviews captured participants’ training perceptions. Quantitative data were analyzed using regression models, 2-sided t tests, and descriptive statistics, while thematic analysis was performed on the interview data of 10 participants. Results: A total of 80 participants completed the outcome measures at 4 weeks. The intervention group demonstrated significant improvements in confidence compared to the control group, including managing OA with exercise-based programs (adjusted mean difference=3.27, 95% CI 2.72-3.81), prescribing exercise (adjusted mean difference=3.13, 95% CI 2.55-3.72), and delivering telehealth (adjusted mean difference=4.41, 95% CI 3.77-5.05). KOAKS scores also improved significantly (mean change=9.46); however, certain belief bias related to OA concepts and the use of scans remained unchanged (25/41, 61% and 27/41, 66%, respectively). Approximately 73% (30/41) of the intervention participants rated the course as extremely useful. Interviews emphasized the need for cultural adaptation and practical telehealth training with real-life scenarios to enhance program applicability. Conclusions: The PEAK program improved Chinese practitioners’ confidence and knowledge in managing knee OA, underscoring e-learning’s potential to support evidence-based OA care in China. To optimize future implementations, further research strategies could include enhancing cultural relevance, addressing misconceptions, and incorporating practical, real-world training. Trial Registration: Chinese Clinical Trial Register ChiCTR2400091007; https://www.chictr.org.cn/showproj.html?proj=239680 %M 40249943 %R 10.2196/71057 %U https://www.jmir.org/2025/1/e71057 %U https://doi.org/10.2196/71057 %U http://www.ncbi.nlm.nih.gov/pubmed/40249943 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e66791 %T User Experience of and Adherence to a Smartphone App to Maintain Behavior Change and Self-Management in Patients With Work-Related Skin Diseases: Multistep, Single-Arm Feasibility Study %A Ristow,Nele %A Wilke,Annika %A Skudlik,Christoph %A John,Swen Malte %A Ludewig,Michaela %+ Department of Dermatology, Environmental Medicine and Health Theory, Institute for Health Research and Education, Osnabrück University, Am Finkenhügel 7a, Osnabrück, 49076, Germany, 49 541 969 7410, neristow@uos.de %K user experience %K mobile health %K mHealth %K app %K smartphone %K complex intervention %K Template for Intervention Description and Replication %K behavior change techniques %K behavior change %K skin diseases %K occupational dermatology %K artificial intelligence %D 2025 %7 18.4.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Smartphone apps are a growing field supporting the prevention of chronic diseases. The user experience (UX) is an important predictor of app use and should be considered in mobile health research. Long-term skin protection behavior is important for those with work-related skin diseases. However, altering health behavior is complex and requires a high level of self-management. We developed a maintenance program consisting of the Mein Hautschutz im Alltag (MiA; “My skin protection in everyday life”) app combined with an individual face-to-face goal-setting interview to support patients in the implementation of skin protection behavior after inpatient rehabilitation. Objective: The objectives of this paper are to (1) describe the intervention in a standardized manner; (2) evaluate the UX, subjective quality, and perceived impact of the MiA app; and (3) evaluate the adherence to the MiA app. Methods: We followed a user-centered and multistage iterative process in 2 steps that combined qualitative and quantitative data. The maintenance program was tested over 12 weeks after discharge from rehabilitation. The UX, subjective quality, and perceived impact were evaluated formatively based on the user version of the Mobile Application Rating Scale after 12 weeks (T2). Adherence was measured using the frequency of interactions with the app. Results: In total, 42 patients took part (with a dropout rate of n=18, 43% at T2). The average age was 49.5 (SD 13.1) years, and 57% (24/42) were male. We found high ratings for the UX, with an average score of 80.18 (SD 8.94) out of a theoretical maximum of 100, but there were a few exceptions in the usability and interaction with the app. The app was most frequently rated with 4 out of 5 stars (15/24, 65%), which indicates a high subjective quality. Furthermore, the app seemed to influence important determinants to implement skin protection behavior. Adherence to skin protection tracking was higher over the study period than adherence to skin documentation and goal assessment. The number of adherent participants to skin protection tracking was higher in the skin care and skin cleansing categories (28/42, 67% each) compared to the skin protection category (13/42, 31%) on day 1 and decreased until day 84 in all dimensions (12/42, 29% each for skin care and skin cleansing; 9/42, 21% for skin protection). Conclusions: The results in terms of adherence met the expectations and were consistent with those of other studies evaluating the use of apps for chronic diseases. Interaction with the app could be increased using artificial intelligence to determine eczema severity via photos. It should be investigated which subgroups have difficulties with usability to individualize the support to a greater degree during onboarding. There is a need for further research regarding the effectiveness of the MiA app on skin protection behavior, quality of life, and eczema severity. %M 40249942 %R 10.2196/66791 %U https://formative.jmir.org/2025/1/e66791 %U https://doi.org/10.2196/66791 %U http://www.ncbi.nlm.nih.gov/pubmed/40249942 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 8 %N %P e63500 %T Effects of Web-Based Single-Session Growth Mindset Interventions for Reducing Adolescent Anxiety: Four-Armed Randomized Controlled Trial %A Zhu,Shimin %A Hu,Yuxi %A Qi,Di %A Tse,Samson %A Chan,Ko Ling %A Sun,Jessica %A Lee,Paul %+ Department of Applied Social Sciences, The Hong Kong Polytechnic University, GH348, 11 Yuk Choi Rd, Hung Hom, Hong Kong, China (Hong Kong), 852 2766 5787, jasmine.zhu@polyu.edu.hk %K belief-in-change %K growth mindset %K mental health %K secondary school students %K brief intervention %K randomized controlled trial %D 2025 %7 18.4.2025 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Anxiety disorders are the most common mental health conditions worldwide, yet 65% of those affected do not access services. The high prevalence of anxiety and the low rate of intervention uptake highlight the urgent need to develop timely, scalable, and effective interventions suitable for adolescents. This study adapted existing single-session interventions (SSIs) to further develop an SSI focused on a growth mindset regarding negative emotions for adolescent mental health. Objective: The study aims to compare the effectiveness of 4 SSIs, SSI of a growth mindset for anxiety (SIGMA), SIGMA with boosters (SIGMA-Booster), SSI of a growth mindset of personality (SSIGP), and an active control group (support therapy [ST]), in reducing adolescent anxiety. Methods: Classes from each secondary school were randomized to 1 of 4 intervention conditions: SIGMA, SIGMA-Booster, SSIGP, or ST. Each intervention took approximately 45 minutes online. Participants reported on anxiety symptoms (primary outcome), depressive symptoms, suicidal/self-harming thoughts, perceived control, hopelessness, attitude toward help-seeking, and psychological well-being (secondary outcomes) at preintervention, 2-week follow-up, and 8-week follow-up. Participants also completed a feedback scale postintervention. Generalized estimating equations were used to examine the effectiveness of the SSIs. Results: A total of 731 adolescents from 7 secondary schools were randomized. The intent-to-treat analysis found a significant decrease in anxiety symptoms. The mean and 95% CI at baseline were 6.8 (6.0-7.6) for SIGMA-Booster, 6.5 (5.8-7.3) for SIGMA, 7.0 (6.2-7.7) for SSIGP, and 6.9 (6.1-7.7) for ST. At the 2-week follow-up, the mean and 95% CI were 5.9 (5.1-6.7) for SIGMA-Booster, 5.7 (4.9-6.5) for SIGMA, 5.4 (4.6-6.2) for SSIGP, and 5.7 (4.9-6.4) for ST. At the 8-week follow-up, the mean and 95% CI were 5.9 (5.1-6.7) for SIGMA-Booster, 5.3 (4.5-6.0) for SIGMA, 5.6 (4.8-6.4) for SSIGP, and 5.8 (5.1-6.6) for ST. These reductions were observed across all 4 groups. Moderation analysis found that participants with higher motivation for change, higher baseline anxiety scores, and fixed mindsets showed greater improvements in anxiety symptoms. Most participants (459/731, 62.8%) viewed the feasibility and acceptability of the SSIs positively. Conclusions: The SSI for all 4 groups was effective in reducing anxiety and depression among adolescents over 8 weeks. Our data suggest the potential benefits of brief web-based interventions for adolescents, which could serve as scalable, destigmatized, and cost-effective alternatives to school-based programs. The intervention effects may have been underestimated, as this study did not exclude adolescents with minimal or no anxiety symptoms. Future studies should focus on the specific effects of interventions for adolescents with varying levels of anxiety symptoms. Trial Registration: ClinicalTrials.gov NCT05027880; https://clinicaltrials.gov/ct2/show/NCT05027880 %M 40249649 %R 10.2196/63500 %U https://pediatrics.jmir.org/2025/1/e63500 %U https://doi.org/10.2196/63500 %U http://www.ncbi.nlm.nih.gov/pubmed/40249649 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e68204 %T Consumer-Grade Neurofeedback With Mindfulness Meditation: Meta-Analysis %A Treves,Isaac %A Bajwa,Zia %A Greene,Keara D %A Bloom,Paul A %A Kim,Nayoung %A Wool,Emma %A Goldberg,Simon B %A Whitfield-Gabrieli,Susan %A Auerbach,Randy P %+ McGovern Institute for Brain Research, Massachusetts Institute of Technology, Building 46-4037, 550 Memorial Dr, Cambridge, MA, 02139, United States, 1 (646) 774 5745, Isaac.Treves@nyspi.columbia.edu %K neurofeedback %K mindfulness %K device %K neurotechnology %K meditation %K stress %K cognition %K Muse %K consumer grade %K meta-analyses %K neuroscientific technology %K neurotechnologies %K randomized %D 2025 %7 17.4.2025 %9 Review %J J Med Internet Res %G English %X Background: There is burgeoning interest in the application of neuroscientific technology to facilitate meditation and lead to beneficial psychological outcomes. One popular approach is using consumer-grade neurofeedback devices to deliver feedback on brain targets during meditation (mindfulness-based neurofeedback). It is hypothesized that optimizing brain targets like alpha and theta band activity may allow meditators to experience deeper mindfulness and thus beneficial outcomes. Objective: This study aimed to systematically review and meta-analyze the impacts of consumer-grade mindfulness-based neurofeedback compared with control conditions. Included studies involved mindfulness practice operationalized as open monitoring or focused attention meditation. This study was preregistered. Methods: A total of 16 randomized controlled training trials, as well as 5 randomized within-participant designs were included, encompassing 763 and 167 unique participants, respectively. Effects were categorized outcomes (ie, psychological distress, cognitive function, and physiological health) and process variables (ie, state mindfulness and brain measures). Study risk of bias, reporting bias, and publication bias were assessed. Results: Samples were typically small (n=30-50), and the majority of studies used mindfulness apps as controls. To deliver neurofeedback, most studies used the Muse device (11/16 randomized controlled trials [RCTs]). There was a modest effect for decreases in psychological distress compared with controls (k=11, g=–0.16, P=.03), and heterogeneity was low (I2< 0.25). However, there was no evidence for improvements in cognition (k=7, g=0.07, P=.48), mindfulness (k=9, g=0.02, P=.83), and physiological health (k=7, g=0.11, P=.57) compared to controls. Mechanistic modulation of brain targets was not found in RCTs or within-participant designs. Sex (male or female), age, clinical status, study quality, active or passive controls, sample size, and neurofeedback duration did not moderate effects. There was some evidence for reporting bias, but no evidence of publication bias. Adverse effects were not assessed in 19 out of 21 studies and not found in the 2 studies that assessed them. Conclusions: Assertions that consumer-grade devices can allow participants to modulate their brains and deepen their meditations are not currently supported. It is possible that neurofeedback effects may rely on “neurosuggestion” (placebo effects of neurotechnology). Future research should examine more extensive calibration and individualization of devices, larger sample sizes, and gold-standard sham-controlled RCTs. %M 40246295 %R 10.2196/68204 %U https://www.jmir.org/2025/1/e68204 %U https://doi.org/10.2196/68204 %U http://www.ncbi.nlm.nih.gov/pubmed/40246295 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e66846 %T Interactive Computer-Adaptive Chronic Kidney Disease (I-C-CKD) Education for Hospitalized African American Patients: Protocol for a Randomized Controlled Trial %A King,Akilah %A Omoniyi,Tayo %A Zasadzinski,Lindsay %A Gaspard,Cynthia %A Gorman,Denesha %A Saunders,Milda %+ Section of General Internal Medicine, Department of Medicine, University of Chicago, 5841 S. Maryland Ave. MC 2007, Chicago, IL, 60637, United States, 1 7737023962, asking@uchicago.edu %K chronic kidney disease %K computerized adaptive education %K end-stage kidney disease %K end-stage renal disease %K glomerular filtration rate %K kidney failure %K usual hospital care %K inpatient %D 2025 %7 17.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: End-stage kidney disease (ESKD) or kidney failure is a condition where the kidneys lose the ability to function. African American individuals are 4 times as likely to develop ESKD compared to White American individuals. In addition, African American patients are less likely to have an optimal dialysis start and to choose renal replacement therapy modalities that align with their goals and values. Our prior work shows that culturally tailored, in-person education improves patient outcomes. This is the foundation for our innovative intervention using an African American virtual patient educator as an option for hospitalized patients with chronic kidney disease (CKD). Objective: The Interactive Computer-Adaptive Chronic Kidney Disease (I-C-CKD) study will determine whether the computerized adaptive education and usual hospital care impact the health literacy of African American patients with kidney disease. It will also assess how patients’ lifestyle and commitment to health goals are impacted by the method of health literacy education. Methods: We will screen, recruit, and enroll hospitalized patients who self-identify as African American and have advanced CKD based on their estimated glomerular filtration rate. Eligible patients who verbally consented will be randomly assigned into either the computerized adaptive education intervention group or the control group (usual hospital care). Patients in the intervention group will receive a culturally tailored, adaptive education module. To analyze pretest, posttest, and follow-up survey results on patient CKD knowledge, ESKD treatment options, and health goals, we will use a paired, 2-tailed t test with a Bonferroni adjustment for multiple comparisons. Results: Recruitment for the I-C-CKD study began on May 2, 2023. We are currently recruiting and have enrolled 96 patients who completed both pretest and posttest surveys as of December 2024. This includes 50 patients in the control group and 46 patients in the intervention group. Data analysis has not occurred. Conclusions: African American individuals often receive less patient education about self-care and treatment options for CKD. We hope this study provides a solution to increase hospitalized African American patients’ knowledge of CKD and motivation for CKD self-care through computerized adaptive education, reduce disparities, and improve patient outcomes. Trial Registration: ClinicalTrials.gov NCT06364358; https://clinicaltrials.gov/study/NCT06364358 International Registered Report Identifier (IRRID): DERR1-10.2196/66846 %M 40245387 %R 10.2196/66846 %U https://www.researchprotocols.org/2025/1/e66846 %U https://doi.org/10.2196/66846 %U http://www.ncbi.nlm.nih.gov/pubmed/40245387 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e72321 %T Optimization of Internet-Delivered Cognitive Behavioral Therapy for Canadian Leaders Within Public Safety: Qualitative Study %A Price,Jill AB %A McCall,Hugh C %A Demyen,Sam A %A Spencer,Shaylee M %A Katz,Benjamin MW %A Clairmont,Alyssa P %A Hadjistavropoulos,Heather D %+ , Canadian Institute for Public Safety Research and Treatment, 3737 Wascana Parkway, Regina, SK, S4S0A2, Canada, 1 3063373418, jill.price@uregina.ca %K first responders %K public safety personnel %K leadership %K mental health %K digital mental health interventions %K internet-delivered cognitive behavioral therapy %D 2025 %7 17.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Canadian public safety personnel (PSP) report high rates of mental health concerns and barriers to treatment. PSPNET is a clinical research unit that offers internet-delivered cognitive behavioral therapy (ICBT) that is free, confidential, and developed with and for PSP. Treatment outcomes are promising with clinically significant symptom improvement (eg, anxiety, depression, and posttraumatic stress) and favorable treatment satisfaction. While these results are promising, research has yet to explore ways to optimize therapist-guided ICBT for leaders within public safety. Optimizing ICBT for leaders is particularly important given their widespread organizational impact. Objective: This study aims to investigate (1) the perceived mental health stressors of Canadian leaders within public safety, (2) the degree to which leaders perceived existing therapist-guided ICBT courses tailored for PSP (ie, PSP Wellbeing Course and PSP PTSD Course) as suitable for their needs, and (3) ways to further optimize therapist-guided ICBT for public safety leaders. Methods: This study included 10 clients who self-identified as being in a supervisory or leadership position within their public safety organization and completed either the therapist-guided PSP Wellbeing Course or PSP PTSD Course. We used descriptive statistics to analyze demographics, mental health symptoms, treatment engagement, and treatment satisfaction. We also used a reflexive thematic analysis of semistructured interview transcripts to assess leaders’ course perceptions and feedback. Results: Canadian leaders within public safety reported occupational and nonoccupational stressors and enrolled in ICBT to support their own or colleagues’ mental health. Most clients enrolled in the PSP Wellbeing Course, accessed 4 of 5 lessons (n=7, 70%), engaged with therapist support (n=7, 70%), and identified as employed (n=8, 80%), White (n=8, 80%), and men (n=7, 70%) with an average age of 45 years. At pretreatment, 80% of clients endorsed clinically significant symptoms of one or more disorders; most often depression (n=7, 70%) and anger (n=6, 60%). Clients reported favorable attitudes toward the ICBT courses with most reporting that they were satisfied with the course (n=9, 90%). Feedback to further optimize ICBT content for leaders included the development of a leader case story (n=6, 60%) and new resources to help leaders apply skills learned in ICBT within the context of their leadership roles (n=4, 40%). Leaders also recommended optimizing ICBT delivery by improving the platform technology and incorporating more multimedia. Conclusions: Canadian leaders within public safety perceived therapist-guided ICBT developed with and for PSP as a suitable treatment option for their needs and identified ways to further optimize its content and delivery. Future research should investigate the impacts of these efforts and explore optimizing ICBT for other groups of clients. Trial Registration: ClinicalTrials.gov NCT04127032, https://www.clinicaltrials.gov/study/NCT04127032; ClinicalTrials.gov NCT04335487, https://clinicaltrials.gov/study/NCT04335487 %M 40245389 %R 10.2196/72321 %U https://www.jmir.org/2025/1/e72321 %U https://doi.org/10.2196/72321 %U http://www.ncbi.nlm.nih.gov/pubmed/40245389 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e64882 %T A Mobile App–Based Intervention (Parentbot–a Digital Healthcare Assistant) for Parents: Secondary Analysis of a Randomized Controlled Trial %A Chua,Joelle Yan Xin %A Choolani,Mahesh %A Chee,Cornelia Yin Ing %A Yi,Huso %A Lalor,Joan Gabrielle %A Chong,Yap Seng %A Shorey,Shefaly %+ Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, 14 Medical Drive, Block MD6, Level 5, Centre for Translational Medicine, Singapore, 117599, Singapore, 65 66011294, nurssh@nus.edu.sg %K perinatal %K mobile app %K app use %K survey response %K parents %K randomized controlled trial %K artificial intelligence %K AI %D 2025 %7 17.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Mobile app–based interventions are viable methods of delivering perinatal care support to parents. A mobile app–based intervention entitled Parentbot–a Digital Healthcare Assistant (PDA) was developed and evaluated via a randomized controlled trial. PDA aimed to provide informational, socioemotional, and psychological support to parents across the perinatal period. As developing such interventions is resource intensive, it is important to evaluate participants’ use and the components that are appreciated by them. Objective: This study aims to examine the (1) relationship between participants’ characteristics and PDA use, (2) relationship between PDA use and parenting outcomes, and (3) relationship between participants’ characteristics and the time taken to respond to the surveys (survey response timing). Methods: This study is the secondary analysis of a randomized controlled trial. A convenient sample of 118 heterosexual couples (236 participants: n=118, 50% mothers and n=118, 50% fathers) from a public tertiary hospital in Singapore were recruited. Data were collected from November 2022 to August 2023. Descriptive statistics were used to summarize the parents’ characteristics and study variables. Linear mixed models were used to examine the effect of (1) participants’ sociodemographic characteristics on PDA use metrics, (2) use metrics on parenting outcomes, and (3) participants’ sociodemographic characteristics on the survey response timing. The Pearson correlation was also used to examine the linear relationships between the PDA use metrics and parenting outcomes. Results: The following parental characteristics were found to be associated with PDA use: antenatal course attendance, gender, religion, ethnicity, and the number of children. After adjusting for baseline values and sociodemographic covariates, only the viewing of educational materials was statistically significantly associated with improvements in parents’ anxiety (β=–0.48, 95% CI –0.94 to –0.009; P=.046), parent-child bonding (β=–0.10, 95% CI –0.19 to –0.01; P=.03), social support (β=0.31, 95% CI 0.08-0.54; P=.01), and parenting satisfaction (β=0.57, 95% CI 0.07-1.07; P=.03) at 1 month post partum. Moreover, parents’ age, ethnicity, grouping, and number of children were found to be related to the survey response timing. Conclusions: As the viewing of PDA’s educational materials was linked to improvements in parents’ perinatal well-being, the provision of educational resources should be prioritized in future app-based parenting interventions. Because the use of other PDA features, such as poster activities, forum posts, and reflection and gratitude exercises, had a limited effect in improving parents’ well-being, future interventions could explore alternative activities to better engage parents. Future mobile app–based parenting interventions could conduct similar evaluations on app use and the effectiveness of specific features to validate the findings of this study. %M 40245395 %R 10.2196/64882 %U https://www.jmir.org/2025/1/e64882 %U https://doi.org/10.2196/64882 %U http://www.ncbi.nlm.nih.gov/pubmed/40245395 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e65185 %T Creating a Usable and Effective Digital Intervention to Support Men to Test for HIV and Link to Care in A Resource-Constrained Setting: Iterative Design Based on A Person-Based Approach and Human Computer Interaction Methods %A Zeitlin,Anya %A Mathenjwa,Thulile %A Zuma,Thembelihle %A Wyke,Sally %A Matthews,Philippa %A McGrath,Nuala %A Seeley,Janet %A Shahmanesh,Maryam %A Blandford,Ann %+ , Africa Health Research Institute, Krith Building, 3rd floor, 719 Umbilo Rd, Durban, 4001, South Africa, 27 315210455, thulile.mathenjwa@ahri.org %K person-based approach %K HIV %K resource-constrained settings %K digital intervention %K user-centered design %K behavior change techniques %K digital health %D 2025 %7 17.4.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: It is challenging to design usable and effective digital health interventions (DHIs). The person-based approach (PBA) has been proposed to incorporate users’ perspectives for the design of DHIs. However, it does not explicitly describe the iterative stages of design and evaluation that are essential in moving from early planning to deployment. For this, we draw on methods from human computer interaction (HCI) that have been developed for various situations. Objective: This study aimed to reflect on the adaptation and synthesis of PBA and HCI approaches to developing DHIs. We present a case study applying both approaches to develop Empowering People through Informed Choices for HIV (EPIC-HIV1), a DHI designed for men living in rural KwaZulu-Natal, South Africa, intended to support them in making an informed choice about whether to take an HIV test and, if necessary, engage in care. Methods: We conducted a retrospective analysis of the documentation generated during the development of EPIC-HIV1 including findings about requirements, design representations, and the results of iterative rounds of testing. We developed an account of the process, the outcomes, and the strengths and limitations of the design and evaluation techniques applied. We also present the design of EPIC-HIV1 and summarize considerations when designing for hard-to-reach people in such settings. Results: The PBA was applied to deliver a first prototype. This helped identify key messages to convey and how to manage issues such as user privacy, but the resulting prototype was judged by the team not to be engaging for potential users, and it was unclear whether the design was inclusive of people with low digital or health literacy. We therefore introduced methods from HCI to iteratively test and refine the app. Working with local community representatives, we conducted four refinement cycles with 29 participants, adapting and retesting the app until no further changes were needed. Key changes included making it clearer what the consequences of selecting options in the app were and changing wording to minimize misconceptions (eg, that the app would test for HIV) while addressing common concerns about testing and emphasizing long-term benefits of engaging with care, if needed. Conclusions: Techniques for developing DHIs need to be situationally appropriate. The PBA enabled us to establish both empirical data and theory to design the content of EPIC-HIV1, but it did not directly inform interaction design to make the app usable and effective for the intended users; HCI techniques tailored to the setting enabled us to refine the app to be easy for men with little familiarity with digital technologies to use within the constraints of the setting. Iterative testing ensured the app was easy to use and that the intended clinical messages were communicated effectively. %M 40244652 %R 10.2196/65185 %U https://formative.jmir.org/2025/1/e65185 %U https://doi.org/10.2196/65185 %U http://www.ncbi.nlm.nih.gov/pubmed/40244652 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e67885 %T Using the Healthy Native Youth Implementation Toolbox to Provide Web-Based Adolescent Health Promotion Decision Support to American Indian and Alaska Native Communities: Implementation Study %A Sidhu,Amrita %A Shegog,Ross %A Craig-Rushing,Stephanie %A Trevino,Nicole %A Singer,Michelle %A Jessen,Cornelia %A Gorman,Gwenda %A Simpson,Sean %A Peskin,Melissa %A Hernandez,Belinda %A Markham,Christine %K implementation %K culturally relevant program %K evidence-based health promotion %K user engagement %K reach %K decision support system %K American Indian %K Alaska %K native communities %K youth %K adolescent %K decision support %K Alaska native %K health inequities %K sexual %K reproductive %K mental health %K AI/AN %K Tribal organization %K Google Analytics %K toolbox %D 2025 %7 16.4.2025 %9 %J JMIR Form Res %G English %X Background: American Indian and Alaska Native (AI/AN) youth experience numerous health inequities, including those in sexual, reproductive, and mental health. Implementation of culturally relevant, age-appropriate evidence-based programs may mitigate these inequities. However, numerous barriers limit the adoption and implementation of evidence-based adolescent health promotion programs in AI/AN communities. Objective: This study examines user reach and engagement from 2022 to 2024 of web-based decision support (the Healthy Native Youth [HNY] website and the embedded HNY Implementation Toolbox), designed to increase the implementation of evidence-based adolescent health promotion programming in AI/AN communities. Methods: Promotional strategies were designed for optimal geographic reach to Tribal organizations, opinion leaders, federal decision makers, and funders. Promotional channels included grassroots, community, and professional networks. We used Google Analytics to examine the uptake of the HNY website and HNY Implementation Toolbox from January 2022 to January 2024. The Toolbox provides culturally relevant tools and templates to help users navigate through 5 phases of program adoption and implementation: Gather, Choose, Prepare, Implement, and Grow. User reach was estimated by demographic characteristics and geographic location; user engagement was estimated by visit frequency and duration, bounce rates, and frequency of page and tool access. Results: Over the study period, page views of the HNY website and HNY Toolbox increased 10-fold and 27-fold, respectively. Over the 2-year evaluation period since the Toolbox “go live” date, approximately 1 in 8 users of the HNY website visited the Toolbox. The majority of HNY website users were located in Washington (n=1515), California (n=1290), and Oregon (n=1019) and were aged between 18 and 24 (n=1559, 21.7%) and 25‐34 (n=1676, 23.29%) years. Toolbox users were primarily located in California (n=1238), Washington (n=1142), and Oregon (n=986), mostly aged between 35 and 44 years (n=444, 35%). Both website and Toolbox users were primarily female, who accessed the site and Toolbox via desktop computers. The most frequently accessed phase pages within the Implementation Toolbox were Gather, Choose, Implement, and Prepare, as supported by bounce rates and average time on page. The most viewed phase was the “Gather” phase, with 3278 views. The most frequently downloaded tools within the Toolbox were Gather: Community Needs and Resource Assessment, with 136 downloads. The phases and tools accessed may have differed based on the user’s goal or stage of implementation. Conclusions: Findings indicate positive initial reach and engagement of the HNY website and HNY Implementation Toolbox among AI/AN educators that has consistently increased over the 2 years. The provision of web-based decision support that guides AI/AN users through the adoption, implementation, and maintenance of culturally relevant, age-appropriate, evidence-based adolescent health promotion programs in their communities may help increase the implementation of effective adolescent health promotion programs to ultimately increase health equity among AI/AN youth. %R 10.2196/67885 %U https://formative.jmir.org/2025/1/e67885 %U https://doi.org/10.2196/67885 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e68757 %T How to Refine and Prioritize Key Performance Indicators for Digital Health Interventions: Tutorial on Using Consensus Methodology to Enable Meaningful Evaluation of Novel Digital Health Interventions %A McCabe,Catherine %A Connolly,Leona %A Quintana,Yuri %A Weir,Arielle %A Moen,Anne %A Ingvar,Martin %A McCann,Margaret %A Doyle,Carmel %A Hughes,Mary %A Brenner,Maria %+ School of Nursing and Midwifery, Trinity College Dublin, 24 D`Olier At, Dublin 2, Dublin, D02 T283, Ireland, 353 1 8933019, camccabe@tcd.ie %K digital health interventions %K key performance indicators %K Delphi technique %K consensus methodology %K drug-related side effects and adverse reactions %K referral %K consultation %D 2025 %7 16.4.2025 %9 Tutorial %J J Med Internet Res %G English %X Digital health interventions (DHIs) have the potential to improve health care and health promotion. However, there is a lack of guidance in the literature for the development, refinement, and prioritization of key performance indicators (KPIs) for the evaluation of DHIs. This paper presents a 4-stage process used in the Gravitate Health project based on stakeholder consultation and consensus for this purpose. The Gravitate Health consortium, which comprises private and public partners from across Europe and the United States, is developing innovative digital health solutions in the form of Federated Open-Source Platform and G-lens to present users with individualized digital information about their medicines. The first stage of this was the consultative process for the development of KPIs involving stakeholder (Gravitate Health project leads) consultations at the planning stages of the project. This resulted in the formation of an extensive list of KPIs organized into 7 categories. The second stage was conducting a scoping review, which confirmed the need for extensive stakeholder consultation in all stages of the KPI development, refinement, and prioritization process. The third stage was a period of further consultation with all consortium members, which resulted in the elimination of 1 category of KPIs. The fourth stage involved using the Delphi technique for refining and prioritizing the remaining 6 categories of KPIs. It is unusual to use this methodology in a nonresearch exercise, but it provided a clear consultative framework and structure that facilitated the achievement of consensus within a large consortium of 250 members on a substantial list of KPIs for the project. Consortium members ranked the relevance and importance of each KPI. The final list of KPIs provides substantial indicators sensitive to the needs of a broad group of stakeholders that are being used to capture real-world data in developing and evaluating DHIs. %M 40239207 %R 10.2196/68757 %U https://www.jmir.org/2025/1/e68757 %U https://doi.org/10.2196/68757 %U http://www.ncbi.nlm.nih.gov/pubmed/40239207 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e63693 %T Testing a Machine Learning–Based Adaptive Motivational System for Socioeconomically Disadvantaged Smokers (Adapt2Quit): Protocol for a Randomized Controlled Trial %A Kamberi,Ariana %A Weitz,Benjamin %A Flahive,Julie %A Eve,Julianna %A Najjar,Reem %A Liaghat,Tara %A Ford,Daniel %A Lindenauer,Peter %A Person,Sharina %A Houston,Thomas K %A Gauvey-Kern,Megan E %A Lobien,Jackie %A Sadasivam,Rajani S %+ Division of Health Informatics and Implementation Science, Department of Population and Quantitative Health Sciences, UMass Chan Medical School, 55 Lake Ave North, Worcester, MA, 01655, United States, 1 774 317 1539, Ariana.Kamberi@umassmed.edu %K smoking cessation %K mHealth %K socioeconomically disadvantaged, biochemical verification %K machine learning %D 2025 %7 16.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Individuals who are socioeconomically disadvantaged have high smoking rates and face barriers to participating in smoking cessation interventions. Computer-tailored health communication, which is focused on finding the most relevant messages for an individual, has been shown to promote behavior change. We developed a machine learning approach (the Adapt2Quit recommender system), and our pilot work demonstrated the potential to increase message relevance and smoking cessation effectiveness among individuals who are socioeconomically disadvantaged. Objective: This study protocol describes our randomized controlled trial to test whether the Adapt2Quit recommender system will increase smoking cessation among individuals from socioeconomically disadvantaged backgrounds who smoke. Methods: Individuals from socioeconomically disadvantaged backgrounds who smoke were identified based on insurance tied to low income or from clinical settings (eg, community health centers) that provide care for low-income patients. They received text messages from the Adapt2Quit recommender system for 6 months. Participants received daily text messages for the first 30 days and every 14 days until the end of the study. Intervention participants also received biweekly texting facilitation messages, that is, text messages asking participants to respond (yes or no) if they were interested in being referred to the quitline. Interested participants were then actively referred to the quitline by study staff. Intervention participants also received biweekly text messages assessing their current smoking status. Control participants did not receive the recommender messages but received the biweekly texting facilitation and smoking status assessment messages. Our primary outcome is the 7-day point-prevalence smoking cessation at 6 months, verified by carbon monoxide testing. We will use an inverse probability weighting approach to test our primary outcome. This involves using a logistic regression model to predict nonmissingness, calculating the inverse probability of nonmissingness, and using it as a weight in a logistic regression model to compare cessation rates between the two groups. Results: The Adapt2Quit study was funded in April 2020 and is still ongoing. We have completed the recruitment of individuals (N=757 participants). The 6-month follow-up of all participants was completed in November 2024. The sample consists of 64% (486/757) female participants, 35% (265/757) Black or African American individuals, 51.1% (387/757) White individuals, and 16% (121/757) Hispanic or Latino individuals. In total, 52.6% (398/757) of participants reported having a high school education or being a high school graduate; 70% (529/757) smoked their first cigarette within 30 minutes of waking, and half (379/757, 50%) had stopped smoking for at least one day in the past year. Moreover, 16.6% (126/757) had called the quitline before study participation. Conclusions: We have recruited a diverse sample of individuals who are socioeconomically disadvantaged and designed a rigorous protocol to evaluate the Adapt2Quit recommender system. Future papers will present our main analysis of the trial. Trial Registration: ClinicalTrials.gov NCT04720625; https://clinicaltrials.gov/study/NCT04720625 International Registered Report Identifier (IRRID): DERR1-10.2196/63693 %M 40239194 %R 10.2196/63693 %U https://www.researchprotocols.org/2025/1/e63693 %U https://doi.org/10.2196/63693 %U http://www.ncbi.nlm.nih.gov/pubmed/40239194 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e56586 %T A Digital Photo Activity Intervention for Nursing Home Residents With Dementia and Their Carers: Mixed Methods Process Evaluation %A Tan,Josephine Rose Orejana %A Neal,David P %A Vilmen,Maria %A Boersma,Petra %A Ettema,Teake P %A Gobbens,Robbert J J %A Sikkes,Sietske A M %A Dröes,Rose-Marie %+ Department of Psychiatry, Amsterdam Public Health Research Institute, Amsterdam UMC, location Vrije Universiteit, Oldenaller 1, Amsterdam, 1081 HJ, The Netherlands, 31 3316459170, j.r.tan@amsterdamumc.nl %K dementia %K psychosocial interventions %K nursing home %K process evaluation %K social interaction %K photos %K art %D 2025 %7 16.4.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Within the framework of a randomized controlled trial investigating the impact of a digital, psychosocial photo activity intervention for residents living with dementia in nursing homes and their informal and formal carers, a process evaluation was conducted to determine factors that affected the implementation of the intervention and potentially influenced the intervention outcomes. Objective: By tracing facilitators and barriers to implementation, the study also aimed to inform future implementation of the photo activity intervention. Methods: Following Medical Research Council guidance, mixed methods were used to investigate context, implementation, and mechanism-of-impact factors during the photo activity intervention via the Fotoscope web application versus a general conversation activity (control). Google Analytics was set up to gain insight into how the Fotoscope web application was used in practice. For quantitative data, descriptive statistics were calculated and differences between groups tested. For qualitative data, thematic analysis was performed. Results: In total, 163 semistructured interviews were conducted with residents (photo activity group: n=29, 17.8%; control: n=29, 17.8%), formal carers (photo activity group: n=23, 14.1%; control: n=27, 16.6%), and informal carers (photo activity group: n=28, 17.2%; control: n=27, 16.6%). Regarding contextual factors, a minority of formal carers in both groups (photo activity group: 4/18, 22%; control: 9/24, 38%) mentioned time and workload as barriers to implementing the intervention. Regarding implementation, 86% (25/29) of the residents in the intervention group felt that the digital photo activity worked well on a tablet. Informal carers from both groups wanted more intervention updates from formal carers. The majority of formal carers from both groups were satisfied with how the training and activities were implemented. Regarding the mechanisms of impact, residents in the photo activity group (27/29, 93%) felt significantly more positive about the conversations with their carer (U=533.0, z=2.865, r=0.39; P=.004). Formal carers in the photo activity group (20/23, 87%) got to know the resident better (U=390.5, z=2.114, r=0.302; P=.04) compared to the formal carers in the control group (21/27, 78%). Formal carers in the photo activity group (23/50, 46%) gave a significantly higher rating to the digital photo activity as a way of getting to know the resident living with dementia better (median 9.00, IQR 7-9; U=419.0, z=2.169, r=0.307; P=.03) compared to formal carers in the control group (27/50, 54%; median 8.00, IQR 6-8). Finally, the majority of formal carers in the photo activity group (14/18, 78%) agreed that the Fotoscope app can be used as part of care activities in the nursing home. Conclusions: The work invested by formal carers in implementing the photo activity did not seem to differ greatly compared to implementing a general conversation activity, suggesting that the digital photo activity, as an easy-to-implement and enjoyable intervention, could be widely implemented and disseminated in nursing homes. International Registered Report Identifier (IRRID): RR2-https://doi.org/10.1186/s12877-021-02632-w %M 40239200 %R 10.2196/56586 %U https://formative.jmir.org/2025/1/e56586 %U https://doi.org/10.2196/56586 %U http://www.ncbi.nlm.nih.gov/pubmed/40239200 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e59997 %T User Perceptions of E-Cigarette Cessation Apps: Content Analysis of App Reviews %A Rodberg,Danielle %A Nawara,Roula %A Taylor,Mischa %A Struik,Laura %+ School of Nursing, University of British Columbia, 1147 Research Road, Kelowna, BC, Canada, 1 4039928122, danielle.rodberg@ubc.ca %K qualitative research %K vaping %K e-cigarette %K mobile phone %K mHealth %K smartphone app %K cessation %K nicotine %K consumer %K perception %K user %K content analysis %K Canada %K experiences %D 2025 %7 15.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Vaping rates in Canada are continuing to increase. In 2019, 4.7% of Canadians used an electronic cigarette (e-cigarette) in the past 30 days, which rose to 5.8% in 2022. In the same year, young adults aged 20-24 years demonstrated the highest use among Canadians, at 19.7%. Given this, existing interventions are not resulting in the desired outcomes, and smartphone apps have the potential to address this gap. Although limited, current evidence highlights that apps can be an effective cessation support; however, a gap persists in understanding the user experience of vaping cessation apps. Objective: The purpose of this study was to explore the user experience of vaping cessation apps through an analysis of app reviews. More specifically, this study aimed to identify positive and negative experiences of app users, as well as highlight recommendations from app users to improve the quality of these apps. Methods: Vaping cessation apps were identified through searches on the Canadian and US versions of Apple App Store and Android Google Play Store in August 2022. Searches revealed a total of 11 vaping cessation apps with app reviews, which resulted in a total of 310 reviews for analysis. Review material was analyzed using a deductive content analysis approach and divided into the following primary categories: content, functionality, aesthetic, cost, and other. These were further divided into 3 secondary categories (praise, criticism, and recommendations) and various tertiary categories. Results: The most discussed primary categories were content, functionality and cost. Comments regarding content tended to be positive (n=103, 33.2%), praising features, such as hypnosis audio sessions (n=29, 28.2%) and tracking features. In contrast, comments tended to criticize functionality (n=58, 18.7%), indicating issues with the functioning of an app that either made the whole app unusable (n=29, 50%) or a specific feature unusable (n=28, 48.3%). Reviews regarding cost were mixed, with 27 (8.7%) positive comments, the majority of these encompassing reviewers satisfied with their purchase (n=17, 63%), and 38 (12.3%) negative comments, including individuals both unsatisfied with their purchase (n=15, 39.5%) and unsatisfied with the free version (n=12, 31.6%). Conclusions: This study is the first of its kind to evaluate the user experience with vaping cessation apps via an analysis of app reviews. App developers may benefit from reading our findings to identify areas to focus on when developing and updating apps. Our study forms a basis for the development of future vaping interventions, as well as future studies. Future research should be conducted on vaping cessation interventions with an emphasis on the user experience because there is limited research available for comparison with the promising results from this study. %M 40233344 %R 10.2196/59997 %U https://www.jmir.org/2025/1/e59997 %U https://doi.org/10.2196/59997 %U http://www.ncbi.nlm.nih.gov/pubmed/40233344 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e68855 %T Feasibility, Acceptability, and Effectiveness of a Smartphone App to Increase Pretransplant Vaccine Rates: Usability Study %A Feldman,Amy G %A Beaty,Brenda L %A Moore,Susan L %A Bull,Sheana %A Wilson,Kumanan %A Atkinson,Katherine M %A Bell,Cameron %A Denize,Kathryn M %A Kempe,Allison %K mobile app %K vaccines %K immunizations %K transplantation %K children %K beta test %K mobile health %K mHealth %D 2025 %7 15.4.2025 %9 %J JMIR Form Res %G English %X Background: Vaccine-preventable infections result in significant morbidity, mortality, and costs in pediatric transplant recipients. Despite intensive medical care in the pretransplant period, less than 20% of children are up to date for age-appropriate vaccines at the time of transplant. Mobile health apps have the potential to improve pretransplant vaccine rates. Objective: This paper aimed to perform phase 2 beta testing of the smartphone app, Immunize PediatricTransplant, to determine (1) if it was effective in achieving up-to-date vaccine status by the time of transplant in a cohort of children awaiting transplants and (2) if the app was feasible and acceptable to parent and transplant provider users. Methods: We recruited 25 dyads of parents and providers of a child awaiting a liver, kidney, or heart transplant at Children’s Hospital Colorado, Ann and Robert H. Lurie Children’s Hospital, and the Children’s Hospital of Philadelphia. Parents and providers filled out an entry questionnaire before app use to gather baseline information. A research team member entered the child’s vaccine records into the app. The parent and provider downloaded and used the app until the transplant to view vaccine records, read vaccine education, communicate with team members, and receive overdue vaccine reminders. After the transplant (or on April 1, 2024, the conclusion of the study), the parent and provider filled out an exit questionnaire to explore feasibility and acceptability of the app. The child’s vaccine records were reviewed to determine if the child was up to date on vaccines at the time of transplant. Results: Twenty-five parent and provider dyads were enrolled; 56% (14/25) had a child awaiting a liver transplant, 28% (7/25) had a child awaiting a kidney transplant, and 16% (4/25) had a child awaiting a heart transplant. At the conclusion of the study, 96% (24/25) of the children were up to date on vaccines. Of the 36 parents and providers who filled out an exit questionnaire, 97% (n=35) agreed or strongly agreed that they felt knowledgeable about pretransplant vaccine use and 86% (n=31) agreed or strongly agreed that communication around vaccines was good after using the app. Further, 91% (20/22) of parents and 79% (11/14) of providers recommended the app to future parents and providers of transplant candidates. Parents and providers suggested that in the future the app should connect directly to the electronic medical record or state vaccine registries to obtain vaccine data. Conclusions: The overwhelming majority of children whose parents and providers used the Immunize PediatricTransplant app were up to date on vaccines at the time of transplant. The majority of app users felt the app was feasible and acceptable. In future iterations of the app and subsequent clinical trials, we will explore whether application programming interfaces might be used to extract vaccine data from the electronic medical record. If implemented broadly, this app has the potential to improve pretransplant vaccine rates, resulting in fewer posttransplant infections and improved posttransplant outcomes. %R 10.2196/68855 %U https://formative.jmir.org/2025/1/e68855 %U https://doi.org/10.2196/68855 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e66335 %T Resource-Oriented Case Management to Implement Recommendations for Patients With Chronic Pain and Frequent Use of Analgesics in General Practices (Project RELIEF): Protocol for a Single-Arm Exploratory Feasibility Study %A Poß-Doering,Regina %A Brinkmöller,Sabrina %A Balzer,Alexandra %A Wurmbach,Viktoria Sophie %A Paul,Cinara %A Stolz,Regina %A Zugaj,Marco Richard %A Tesarz,Jonas %A Wensing,Michel %A Straßner,Cornelia %+ Department of Primary Care and Health Services Research, Medical Faculty, Heidelberg University, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, Heidelberg, 69120, Germany, 49 622156 ext 38643, regina.poss-doering@med.uni-heidelberg.de %K chronic noncancer pain %K case management %K primary care %K general practice resource-oriented %K chronic pain %K analgesics %K pharmacological treatment %K pain medications %K holistic approach %K feasibility %K single-arm %K exploratory %K pilot study %K screening %K questionnaire %K survey %K protocol %D 2025 %7 15.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic noncancer pain (CNCP) is a frequent reason for counseling in general practice. Current German guidelines emphasize its biopsychosocial etiology and the importance of self-care and nonpharmacological treatment strategies such as education, physical and social activity, and psychological approaches. Comprehensive assessments are necessary to individualize treatment maximally and monitor appropriate use of pain medication. General practitioners face many challenges in implementing holistic pain management, which considers biological, psychological, and social aspects. In project RELIEF (resource-oriented case management to implement recommendations for patients with chronic pain and frequent use of analgesics in general practices), a case management program was developed to facilitate implementation of guideline recommendations on pain management regarding medical assessment and monitoring, patient and practice team education, promotion of self-care strategies, and rational pharmacotherapy. Objective: We evaluated the feasibility of the intervention and study procedures before applying them in a larger cluster randomized controlled trial. Our secondary objective is to estimate potential effects of the complex intervention. Methods: A single-arm trial with general practices and patients with CNCP and analgesics use will be conducted, accompanied by a mixed methods process evaluation. The intervention comprises 5 components, including software-supported medical pain history, 3 scheduled structured appointments, e-learning on CNCP for general practitioners and medical assistants, educational material for patients, toolbox with information on (regional) resources for patients and practice teams. Participating practices will be located in the federal state of Baden-Württemberg, Germany, and will recruit eligible patients (adults with CNCP for more than 3 months, with at least moderate pain-related disability, permanent or on-demand use of analgesics or co-analgesics in the previous 4 weeks, and practice team assessed ability to participate actively in the trial). A questionnaire given to the first 150 adult patients entering the practice in February 2025 will help screen eligible patients. The primary objective will be measured by a set of predefined indicators. The key secondary outcome is pain-related disability measured by the Pain Disability Index German version. All participants will be asked to participate in the process evaluation. Outcome evaluation data will be gathered by paper-based and digitally provided questionnaires to be completed by participants. Process evaluation data will be gathered in surveys and a qualitative study. Descriptive analyses will be performed. Results: Recruitment occurred between October and December 2024. Targeted sample size was 6 practices and 50 patients. The intervention period will be February-June 2025. It is expected that eligible patients will benefit from the intervention and that improved medication management and intensified use of nonpharmacological treatment strategies will reduce pain-related disabilities and other patient-reported outcomes. Conclusions: This study will provide valuable information regarding feasibility and potential effects before testing the intervention in a confirmatory cluster randomized controlled trial. Trial Registration: German Clinical Trials Register DRKS00034831; https://www.drks.de/search/de/trial/DRKS00034831 International Registered Report Identifier (IRRID): PRR1-10.2196/66335 %M 40233357 %R 10.2196/66335 %U https://www.researchprotocols.org/2025/1/e66335 %U https://doi.org/10.2196/66335 %U http://www.ncbi.nlm.nih.gov/pubmed/40233357 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e66301 %T Evaluating User Engagement With a Real-Time, Text-Based Digital Mental Health Support App: Cross-Sectional, Retrospective Study %A Coffield,Edward %A Kausar,Khadeja %+ , Department of Population Health, Hofstra University, 255 Hofstra University, 101 Oak Street Center, Room 100A, Hempstead, NY, 11549, United States, 1 516 463 7019, edward.coffield@hofstra.edu %K mental health support %K text %K app %K utilization %K mobile %K on demand %K scheduled %K mHealth %K mobile health %K app %K student %K university %K college %K mental health %K employee %K job %K work %K occupational health %K counselor %K counseling %K usage %K engagement %K self-reported %D 2025 %7 14.4.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Approximately 20% of US adults identify as having a mental illness. Structural and other barriers prevent many people from receiving mental health services. Digital mental health apps that provide 24-hour, real-time access to human support may improve access to mental health services. However, information is needed regarding how and why people engage with licensed counselors through a digital, real-time, text-based mental health support app in nonexperimental settings. Objective: This study aimed to evaluate how people engage with Counslr, a 24-hour, digital, mental health support app where users communicate in real time with human counselors through text messaging. Specifically, access patterns (eg, day of the week and time of session) and reasons for accessing the platform were examined. Furthermore, whether differences existed between session types (on-demand or scheduled) and membership types (education or noneducation) in regard to access patterns and why people accessed the platform were evaluated. Methods: The study population (users) consisted of students whose schools, universities, or colleges partnered with Counslr and employees whose organizations also partnered with Counslr. Users participated in text-based mental health support sessions. In these sessions, users engaged with licensed counselors through digital, text-based messaging in real time. Users could initiate an on-demand session or schedule a session 24 hours a day. User engagement patterns were evaluated through session length, session day, session time, and self-reported reasons for initiating the session. The data were stratified by membership type (education [students] or noneducation [employees]) and session type (on-demand or scheduled) to evaluate whether differences existed in usage patterns and self-reported reasons for initiating sessions by membership and session types. Results: Most students (178/283, 62.9%) and employees (28/44, 63.6%) accessed Counslr through on-demand sessions. The average and median session times were 40 (SD 15.3) and 45 minutes. On-demand sessions (37.9 minutes) were shorter (P=.001) than scheduled sessions (43.5 minutes). Most users (262/327, 80.1%) accessed Counslr between 7 PM and 5 AM. The hours that users accessed Counslr did not statistically differ by membership type (P=.19) or session type (P=.10). Primary self-reported reasons for accessing Counslr were relationship reasons, depression, and anxiety; however, users initiated sessions for a variety of reasons. Statistically significant differences existed between membership and session types (P<.05) for some of the reasons why people initiated sessions. Conclusions: The novel findings of this study illustrate that real-time, digital mental health support apps, which offer people the opportunity to engage with licensed counselors outside of standard office hours for a variety of mental health conditions, may help address structural barriers to accessing mental health support services. Additional research is needed to evaluate the effectiveness of human-based apps such as Counslr and whether such apps can also address disparities in access to mental health support services among different demographic groups. %M 40228290 %R 10.2196/66301 %U https://formative.jmir.org/2025/1/e66301 %U https://doi.org/10.2196/66301 %U http://www.ncbi.nlm.nih.gov/pubmed/40228290 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e65357 %T The EmpkinS-EKSpression Reappraisal Training Augmented With Kinesthesia in Depression: One-Armed Feasibility Study %A Keinert,Marie %A Schindler-Gmelch,Lena %A Rupp,Lydia Helene %A Sadeghi,Misha %A Richer,Robert %A Capito,Klara %A Eskofier,Bjoern M %A Berking,Matthias %+ Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Nägelsbachstraße 25a, Erlangen, 91052, Germany, 49 9131 8567563, marie.keinert@fau.de %K depression %K cognitive reappraisal %K facial expression %K kinesthesia %K smartphone-based intervention %K mobile phone %D 2025 %7 14.4.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Harboring dysfunctional depressogenic cognitions contributes to the development and maintenance of depression. A central goal of cognitive behavioral therapy (CBT) for depression is to invalidate such cognitions via cognitive reappraisal (CR). However, relatively low remission rates and high dropout rates in CBT demonstrate the need for further improvement. Potentially, the effects of CBT could be enhanced by addressing not only dysfunctional depressogenic cognitions but also body states associated with depression. This may be done, for example, by systematically pairing the invalidation of depressogenic cognitions with the performance of antidepressive kinesthesia. Objective: This study aimed to examine the feasibility and clinical potential of a smartphone-based cognitive restructuring task that required users to deliberately perform antidepressive kinesthesia in conjunction with the rejection of depressogenic statements and the affirmation of antidepressive statements. This feasibility study was conducted as a precursor to a large-scale randomized controlled trial. Methods: In total, 10 healthy participants engaged in a single 90-120-minute session of smartphone-based CR training. During the training, they completed 2 phases in which they were required to reject 20 depressogenic and affirm 20 antidepressive statements, respectively. Diagnostic assessments were conducted 1 week (T1) before and directly prior (T2) to the training, and again directly posttraining (T3) and at a 2-week follow-up posttraining (T4). Feasibility outcomes assessed at T3 included intervention safety recorded by study therapists, compliance, technical feasibility, usability assessed using the Short Version of the User Experience Questionnaire (UEQ-S), and acceptability assessed using the UEQ-S and self-developed items. Preliminary clinical potential was evaluated via single-item ratings of current depressed and positive mood assessed continuously during the training. Feasibility outcomes were analyzed descriptively, and clinical potential was examined using paired-sample t tests of pre and post ratings of mood at each training phase. Results: Overall, the results indicated that the training was safe, feasible, and usable (UEQ-S pragmatic quality scale: mean 1.45, SD 0.71). However, acceptance was limited (UEQ-S hedonic quality scale: mean 1.05, SD 0.79). While 80% (8/10) of the participants were generally satisfied with the training, 80% (8/10) would recommend it to a friend, 90% (9/10) found it interesting, and 80% (8/10) rated it as “leading edge,” 40% (4/10) to 70% (7/10) did not consider it particularly helpful and 50% (5/10) found it repetitive. Preliminary results regarding clinical potential were promising, with significant increases in positive mood (rejection: Hedges g=0.63; affirmation: Hedges g=0.25), whereas changes in depressed mood were not significant. Conclusions: This study evaluated the feasibility and acceptability of a smartphone-based CR training augmented with validating and invalidating kinesthesia. This provided valuable insights for further optimizing the intervention for the subsequent randomized controlled trial, but also potential similar interventions. If future studies confirm their clinical potential, such interventions offer a promising approach to enhancing CBT for depression. Trial Registration: OSF Registries pw6ma; https://osf.io/pw6ma/ %R 10.2196/65357 %U https://formative.jmir.org/2025/1/e65357 %U https://doi.org/10.2196/65357 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 13 %N %P e55433 %T Exploring the Potential of a Digital Intervention to Enhance Couple Relationships (the Paired App): Mixed Methods Evaluation %A Aicken,Catherine %A Gabb,Jacqui %A Di Martino,Salvatore %A Witney,Tom %A Lucassen,Mathijs %+ Faculty of Arts & Social Sciences, The Open University, Walton Hall, Milton Keynes, MK7 6BJ, United Kingdom, jacqui.gabb@open.ac.uk %K digital intervention %K couple relationships %K romantic relationships %K relationship quality %K app %K digital technology %K couples %K internet-based intervention %K evaluation research %K mobile phone %D 2025 %7 14.4.2025 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Despite the effects of poor relationship quality on individuals’, couples’, and families’ well-being, help seeking often does not occur until problems arise. Digital interventions may lower barriers to engagement with preventive relationship care. The Paired app, launched in October 2020, aims to strengthen and enhance couple relationships. It provides daily questions, quizzes, tips, and detailed content and facilitates in-app sharing of question and quiz responses and tagged content between partners. Objective: To explore the potential of mobile health to benefit couple relationships and how it may do this, we examined (1) Paired’s impact on relationship quality and (2) its mechanisms of action. Methods: This mixed methods evaluation invited Paired subscribers to complete (1) brief longitudinal surveys over 3 months (n=440), (2) a 30-item web-based survey (n=745), and (3) in-depth interviews (n=20). For objective 1, survey results were triangulated to determine associations between relationship quality measures and the duration and frequency of Paired use, and qualitative data were integrated to provide explanatory depth. For objective 2, mechanisms of action were explored using a dominant qualitative approach. Results: Relationship quality improved with increasing duration and frequency of Paired use. Web-based survey data indicate that the Multidimensional Quality of Relationship Scale score (representing relationship quality on a 0-10 scale) was 35.5% higher (95% CI 31.1%-43.7%; P=.002), at 7.03, among people who had used Paired for >3 months compared to 5.19 among new users (≤1 wk use of Paired), a trend supported by the longitudinal data. Of those who had used Paired for >1 month, 64.3% (330/513) agreed that their relationship felt stronger since using the app (95% CI 60.2%-68.4%), with no or minimal demographic differences. Regarding the app’s mechanisms of action, interview accounts demonstrated how it prompted and habituated meaningful communication between partners, both within and outside the app. Couples made regular times in their day to discuss the topics Paired raised. Daily questions were sometimes lighthearted and sometimes concerned topics that couples might find challenging to discuss (eg, money management). Interviewees valued the combination of fun and seriousness. It was easier to discuss challenging topics when they were raised by the “neutral” app, rather than during stressful circumstances or when broached by 1 partner. Engagement seemed to be enhanced by users’ experience of relationship benefits and by the app’s design. Conclusions: This study demonstrates proof of concept, showing that Paired may have the potential to improve relationship quality over a relatively short time frame. Positive relationship practices became embedded within couples’ daily routines, suggesting that relationship quality improvements might be sustained. Digital interventions can play an important role in the relationship care ecosystem. The mixed methods design enabled triangulation and integration, strengthening our findings. However, app users were self-selecting, and methodological choices impact our findings’ generalizability. %R 10.2196/55433 %U https://mhealth.jmir.org/2025/1/e55433 %U https://doi.org/10.2196/55433 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e64023 %T Efficacy of a Personalized Mobile Health Intervention (BedTime) to Increase Sleep Duration Among Short-Sleeping Patients With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial %A Ban,Yuki %A Waki,Kayo %A Nakada,Ryohei %A Isogawa,Akihiro %A Miyoshi,Kengo %A Waki,Hironori %A Kato,Shunsuke %A Sawaki,Hideaki %A Murata,Takashi %A Hirota,Yushi %A Saito,Shuichiro %A Nishikage,Seiji %A Tone,Atsuhito %A Seno,Mayumi %A Toyoda,Masao %A Kajino,Shinichi %A Yokota,Kazuki %A Tsurutani,Yuya %A Yamauchi,Toshimasa %A Nangaku,Masaomi %A Ohe,Kazuhiko %+ Department of Biomedical Informatics, Graduate School of Medicine, The University of Tokyo, 7 Chome-3-1 Hongo, Bunkyo City, Tokyo, 113-8654, Japan, 81 358009129, kwaki-tky@m.u-tokyo.ac.jp %K digital therapeutics %K behavior change %K Theory of Planned Behavior %K sleep duration %K type 2 diabetes %K randomized controlled trial %D 2025 %7 14.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: A strong association exists between sleep duration and glycemic control in patients with type 2 diabetes (T2D), yet convincing evidence of a causal link remains lacking. Improving sleep is increasingly emphasized in clinical T2D treatment guidance, highlighting the need for effective, scalable sleep interventions that can affordably serve large populations through mobile health (mHealth). Objective: This study aims to pilot an intervention that extends sleep duration by modifying bedtime behavior, assessing its efficacy among short-sleeping (≤6 hours per night) patients with T2D, and establishing robust evidence that extending sleep improves glycemic control. Methods: This randomized, single-blinded, multicenter study targets 70 patients with T2D from 9 institutions in Japan over a 12-week intervention period. The sleep extension intervention, BedTime, is developed using the Theory of Planned Behavior (TPB) and focuses on TPB’s constructs of perceived and actual behavioral control (ABC). The pilot intervention combines wearable actigraphy devices with SMS text messaging managed by human operators. Both the intervention and control groups will use an actigraphy device to record bedtime, sleep duration, and step count, while time in bed (TIB) will be assessed via sleep diaries. In addition, the intervention group will receive weekly bedtime goals, daily feedback on their bedtime performance relative to those goals, identify personal barriers to an earlier bedtime, and select strategies to overcome these barriers. The 12-week intervention period will be followed by a 12-week observational period to assess the sustainability of the intervention’s effects. The primary outcome is the between-group difference in the change in hemoglobin A1c (HbA1c) at 12 weeks. Secondary outcomes include other health measures, sleep metrics (bedtime, TIB, sleep duration, total sleep time, and sleep quality), behavioral changes, and assessments of the intervention’s usability. The trial commenced on February 8, 2024, and is expected to conclude in February 2025. Results: Patient recruitment ended on August 29, 2024, with 70 participants enrolled. The intervention period concluded on December 6, 2024, and the observation period ended on February 26, 2025, with 70 participants completing the observation period. The data analysis is currently underway, and results are expected to be published in July 2025. Conclusions: This trial will provide important evidence on the causal link between increased sleep duration and improved glycemic control in short-sleeping patients with T2D. It will also evaluate the efficacy of our bedtime behavior change intervention in extending sleep duration, initially piloted with human operators, with the goal of future implementation via an mHealth smartphone app. If proven effective, this intervention could be a key step toward integrating sleep-focused mHealth into the standard treatment for patients with T2D in Japan. Trial Registration: Japan Registry of Clinical Trials jRCT1030230650; https://jrct.niph.go.jp/latest-detail/jRCT1030230650 International Registered Report Identifier (IRRID): DERR1-10.2196/64023 %M 40228289 %R 10.2196/64023 %U https://www.researchprotocols.org/2025/1/e64023 %U https://doi.org/10.2196/64023 %U http://www.ncbi.nlm.nih.gov/pubmed/40228289 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e63928 %T Assessment of Gait Parameters Using Wearable Sensors and Their Association With Muscle Mass, Strength, and Physical Performance in Korean Older Adults: Cross-Sectional Study %A Shin,Jinyoung %A Kweon,Hyuk Jung %A Choi,Jaekyung %K gait analysis %K sarcopenia %K wearable electronic devices %K muscle mass %K physical performance %K older adults %K geriatric %K cross-sectional study %K outpatient clinic %K Korea %K mHealth %K mobile health %D 2025 %7 10.4.2025 %9 %J JMIR Form Res %G English %X Background: Gait speed indicates the onset or decline of physical performance in sarcopenia. However, real-time measurements of other gait parameters, such as step length, stride length, step width, and support time, are limited. The advent of wearable technology has facilitated the measurement of these parameters, necessitating further investigation into their potential applications. Objective: This study aimed to investigate the relationship between gait parameters measured using wearable sensors and muscle mass, strength, and physical performance in community-dwelling older adults. Methods: In a cross-sectional study of 91 participants aged ≥65 years, gait parameters, such as step count, step length, cadence, single and double support times, vertical oscillation, and instantaneous vertical loading rate (IVLR), measured using a wireless earbud device, were analyzed on the basis of the appendicular skeletal muscle mass index (SMI), calf circumference, handgrip strength, 5-time chair stand test, short physical performance battery (SPPB), and the SARC-F (strength, assistance with walking, rise from a chair, climb stairs and fall frequency) questionnaire. This study was conducted from July 10 to November 1, 2023, at an outpatient clinic of a university hospital in Seoul, Korea. Multiple regression analysis was performed to investigate independent associations after adjusting for age, sex, BMI, and comorbidities. Results: Among 91 participants (45 men and 46 women; mean age 74.1 years for men and 73.6 years for women), gait speed and vertical oscillation showed negative associations with their performance in the 5-time chair stand test (P<.001) and SARC-F and positive associations with their performance in the SPPB (P<.001). Vertical oscillations were also associated with grip strength (P=.003). Single and double support times were associated with performance in the 5-time chair stand test and SPPB (P<.001). In addition, double support time was associated with SARC-F scores (P<.001). Gait speed, support time, vertical oscillation, and IVLR showed independent associations with performance in the 5-time chair stand test and SPPB (P<.001), both related to muscle strength or physical performance. Gait speed, double support time, and vertical oscillation all had significant associations with SARC-F scores. Conclusions: This study demonstrated a significant association between gait monitoring using wearable sensors and quantitative assessments of muscle strength and physical performance in older people. Furthermore, this study substantiated the extensive applicability of diverse gait parameters in predicting sarcopenia. %R 10.2196/63928 %U https://formative.jmir.org/2025/1/e63928 %U https://doi.org/10.2196/63928 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e69873 %T A Novel Just-in-Time Intervention for Promoting Safer Drinking Among College Students: App Testing Across 2 Independent Pre-Post Trials %A Chow,Philip I %A Smith,Jessica %A Saini,Ravjot %A Frederick,Christina %A Clark,Connie %A Ritterband,Maxwell %A Halbert,Jennifer P %A Cheney,Kathryn %A Daniel,Katharine E %A Ingersoll,Karen S %K alcohol %K college students %K smartphone intervention %K binge drinking %K safe drinking %D 2025 %7 10.4.2025 %9 %J JMIR Hum Factors %G English %X Background: Binge drinking, which is linked to various immediate and long-term negative outcomes, is highly prevalent among US college students. Behavioral interventions delivered via mobile phones have a strong potential to help decrease the hazardous effects of binge drinking by promoting safer drinking behaviors. Objective: This study aims to evaluate the preliminary efficacy of bhoos, a novel smartphone app designed to promote safer drinking behaviors among US college students. The app offers on-demand educational content about safer alcohol use, provides dynamic feedback as users log their alcohol consumption, and includes an interactive drink tracker that estimates blood alcohol content in real time. Methods: The bhoos app was tested in 2 independent pre-post studies each lasting 4 weeks, among US college students aged 18‐35 years. The primary outcome in both trials was students’ self-reported confidence in using protective behavioral strategies related to drinking, with self-reported frequency of alcohol consumption over the past month examined as a secondary outcome. Results: In study 1, bhoos was associated with increased confidence in using protective behavioral strategies. Students also endorsed the high usability of the app and reported acceptable levels of engagement. Study 2 replicated findings of increased confidence in using protective behavioral strategies, and demonstrated a reduction in the self-reported frequency of alcohol consumption. Conclusions: Bhoos is a personalized, accessible, and highly scalable digital intervention with a strong potential to effectively address alcohol-related behaviors on college campuses. %R 10.2196/69873 %U https://humanfactors.jmir.org/2025/1/e69873 %U https://doi.org/10.2196/69873 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e60758 %T Efficacy of a Digital Educational Intervention for Patients With Type 2 Diabetes Mellitus: Multicenter, Randomized, Prospective, 6-Month Follow-Up Study %A Caballero Mateos,Irene %A Morales Portillo,Cristóbal %A Lainez López,María %A Vilches-Arenas,Ángel %+ , Endocrinology and Nutrition Department, Vithas Hospital, Avda Plácido Fernández Viagas s/n. 3ª floor, Castilleja de la Cuesta, Sevilla, 41009, Spain, 34 955 00 80 00, irenecaballerom@hotmail.com %K body composition %K type 2 diabetes mellitus %K digital %K metabolic control %K social networks %K satisfaction %K telemedicine %D 2025 %7 10.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Adherence to therapies and metabolic control among patients with type 2 diabetes mellitus (T2DM) remain challenging. The use of new technologies, such as telemedicine, digitalized systems, and social networks, could improve self-management and disease control. Objective: We evaluated the efficacy of a digital educational intervention for patients with T2DM, expressed as changes in glycated hemoglobin (HbA1c) and body composition and evaluation of the response using validated questionnaires of satisfaction with health care professionals (Instrument for Evaluation of the Experience of Chronic Patients), Diabetes Knowledge Scale (ECODI), and adherence to treatment over 6 months of follow-up (Morisky, Green, Levine Medication Assessment Questionnaire). Methods: This multicenter, randomized, prospective study included adults with T2DM with poor metabolic control who started treatment with glucagon-like peptide-1 receptor agonists. Patients were randomized to digital intervention or usual care. The intervention group received education through social networks and digital tools in a structured program of healthy lifestyle changes. This was provided by a “Digital Coach” for weekly and on-demand advice and individualized support. Baseline and follow-up demographic, clinical parameter, adherence, and quality of life data were collected. Results: We included 85 patients (control: n=41; intervention: n=44). Both groups were matched regarding demographics, physical examination, insulin, and biochemical parameters. We observed a reduction in body weight (intervention: –8.7, SD 6.1 kg vs control: –4.9, SD 5.0 kg; t83=–3.13; P=.002), BMI (intervention: –3.0, SD 2.1 kg/m2 vs control: –1.8, SD 1.8 kg/m2; t83=–2.82; P=.006), and fast mass in both groups but greater in the intervention group. There were greater reductions in fasting plasma glucose (intervention: 122.6, SD 81.5 mg/dL vs control: 70.5, SD 72.9 mg/dL; t83=3.10; P=.004) and HbA1c (intervention: 3.7%, SD 1.9% vs control: 2.6%, SD 2.1%; t83=2.54; P=.006) in the intervention group. Although there was no significant change in the Spanish version of the Diabetes Quality of Life Questionnaire (EsDQOL) satisfaction score in the control group after 6 months of follow-up (0.7, SD 19.8), there was a marked reduction in EsDQOL satisfaction score in the intervention group (–13.7, SD 23.1; t83=–3.08; P=.02). According to the ECODI scale, knowledge about diabetes increased more in the intervention group (intervention: 0.3, SD 1.8 vs control: 1.5, SD 1.5; t83=–3.33; P=.001). Although the medication adherence score worsened in the control group after 6 months, it significantly improved with the intervention (control: –8% vs intervention: 13.8%; χ21=0.35; P=.01). Patients’ health care experiences improved with the intervention but not with the control. Conclusions: The digital educational intervention was effective at improving glycemic control, body composition, adherence, and patient satisfaction compared with usual care in patients with T2DM. The implementation of digital tools and social media could highly improve the multidisciplinary approach to the management of this population. Trial Registration: ClinicalTrials.gov NCT06850129; https://clinicaltrials.gov/study/NCT06850129 %M 40209213 %R 10.2196/60758 %U https://www.jmir.org/2025/1/e60758 %U https://doi.org/10.2196/60758 %U http://www.ncbi.nlm.nih.gov/pubmed/40209213 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e68936 %T Digital Health Intervention on Awareness of Vaccination Against Influenza Among Adults With Diabetes: Pragmatic Randomized Follow-Up Study %A Fundoiano-Hershcovitz,Yifat %A Lee,Felix %A Stanger,Catherine %A Breuer Asher,Inbar %A Horwitz,David L %A Manejwala,Omar %A Liska,Jan %A Kerr,David %+ Dario Health, Ofek 8, 5 Tarshish St, Caesarea, 3079821, Israel, 972 0525296979, yifat@dariohealth.com %K digital health %K diabetes management %K influenza vaccination %K flu vaccination awareness %K mobile health %D 2025 %7 10.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Diabetes mellitus significantly increases the risk of severe complications from influenza, necessitating targeted vaccination efforts. Despite vaccination being the most effective preventive measure, coverage remains below the World Health Organization’s targets, partly due to limited awareness among patients. This study evaluated a digital health intervention aimed at improving influenza vaccination rates among adults with diabetes. Objective: This study aimed to demonstrate the effectiveness of digital health platforms in increasing vaccination rates among people with diabetes and to emphasize the impact of tailored messaging frequency on patient engagement and health behavior change. We hypothesized that digital tools providing empirical evidence of increased health risk awareness can effectively drive preventive actions. Methods: The study leveraged the Dario (Dario Health Corp) digital health platform to retrospectively analyze data from 64,904 users with diabetes assigned by the platform into three groups: (1) Group A received previously studied monthly flu nudge messages; (2) Group B received an adapted intervention with 2-3 monthly messages; (3) Group C served as the control with no intervention. Surveys were conducted at baseline, 3 months, and 6 months to assess vaccination status, awareness of influenza risks, and recollection of educational content. Statistical analyses, including logistic regression, chi-square tests, and t tests, were used to evaluate differences between groups. Results: Out of 64,904 users, 8431 completed the surveys. Vaccination rates were 71.0% in group A, 71.9% in group B, and 70.5% in group C. Group B showed significantly higher awareness of influenza risks compared with the control group odds ratio (OR; OR 1.35, 95% CI 1.12-1.63; P=.001), while group A did not (OR 1.10, 95% CI 0.92-1.32; P=.27). Recollection of educational content was also higher in groups A (OR 1.29, 95% CI 1.07-1.56; P=.008) and B (OR 1.92, 95% CI 1.59-2.33; P<.001) compared with the control. In addition, a significant correlation between awareness and vaccination rates was found only in group B (χ2(df=1)=6.12, P=.01). Conclusions: The adapted digital intervention (group B) effectively increased awareness of influenza risks and recollection of educational content, which correlated with the higher trend in vaccination rates. This study demonstrates the potential of digital health tools to enhance influenza vaccination among people with diabetes by improving risk awareness and education. Further research should focus on optimizing these interventions to achieve significant improvements in vaccination uptake and overall public health outcomes. Trial Registration: ClinicalTrials.gov NCT06840236; https://clinicaltrials.gov/study/NCT06840236 %M 40209214 %R 10.2196/68936 %U https://www.jmir.org/2025/1/e68936 %U https://doi.org/10.2196/68936 %U http://www.ncbi.nlm.nih.gov/pubmed/40209214 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e64138 %T Safety and Efficacy of Modular Digital Psychotherapy for Social Anxiety: Randomized Controlled Trial %A Garvert,Mona M %A McFadyen,Jessica %A Linke,Stuart %A McCloud,Tayla %A Meyer,Sofie S %A Sobanska,Sandra %A Sharp,Paul B %A Long,Alex %A Huys,Quentin J M %A Ahmadi,Mandana %+ Alena, 25 Wilton Rd, Pimlico, London, SW1V 1LW, United Kingdom, 44 09313185834, mona.garvert@gmail.com %K social anxiety disorder %K randomized controlled trial %K digital mental health %K cognitive behavioral therapy %K internet-delivered CBT %D 2025 %7 10.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Social anxiety disorder is a common mental health condition characterized by an intense fear of social situations that can lead to significant impairment in daily life. Cognitive behavioral therapy (CBT) has been recognized as an effective treatment; however, access to therapists is limited, and the fear of interacting with therapists can delay treatment seeking. Furthermore, not all individuals respond. Tailoring modular treatments to individual cognitive profiles may improve efficacy. We developed a novel digital adaptation of CBT for social anxiety that is both modular and fully digital without a therapist in the loop and implemented it in the smartphone app Alena. Objective: This study aimed to evaluate the safety, acceptability, and efficacy of the new treatment in online participants with symptoms of social anxiety. Methods: In total, 2 web-based randomized controlled trials (RCTs) comparing individuals with access to the treatment through the app to a waitlist control group were conducted. Participants were recruited on the web and reported Social Phobia Inventory (SPIN) total scores of ≥30. Primary outcomes were safety and efficacy over 6 weeks in 102 women aged 18 to 35 years (RCT 1) and symptom reduction (SPIN scores) after 8 weeks in 248 men and women aged 18 to 75 years (RCT 2). Results: In RCT 1, active and control arm adverse event frequency and severity were not distinguishable (intervention: 7/52, 13%; waitlist control: 8/50, 16%; χ21=0.007; P=.93). App acceptability was high, with a median completion rate of 90.91% (IQR 54.55%-100%). Secondary outcomes suggested greater symptom reduction in the active arm (mean SPIN score reduction −9.83, SD 12.80) than in the control arm (mean SPIN score reduction −4.13, SD 11.59; t90=−2.23; false discovery rate P=.04; Cohen d=0.47). RCT 2 replicated these findings. Adverse event frequency was comparable across the 2 groups (intervention: 20/124, 16.1%; waitlist control: 21/124, 16.8%; χ21<0.001; P>.99). Despite a longer treatment program, median completion remained high (84.85%, IQR 51.52%-96.97%). SPIN score reduction was greater in the active arm (mean −12.89, SD 13.87) than in the control arm (mean −7.48, SD 12.24; t227=−3.13; false discovery rate P=.008; Cohen d=0.42). Conclusions: The web-only, modular social anxiety CBT program appeared safe, acceptable, and efficacious in 2 independent RCTs on online patient groups with self-reported symptoms of social anxiety. Trial Registration: ClinicalTrials.gov NCT05858294; https://clinicaltrials.gov/study/NCT05858294 (RCT 1) and ClinicalTrials.gov NCT05987969; https://clinicaltrials.gov/study/NCT05987969 (RCT 2) %M 40208666 %R 10.2196/64138 %U https://www.jmir.org/2025/1/e64138 %U https://doi.org/10.2196/64138 %U http://www.ncbi.nlm.nih.gov/pubmed/40208666 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e67166 %T Efficacy of a Personalized mHealth App in Improving Micronutrient Supplement Use Among Pregnant Women in Karachi, Pakistan: Parallel-Group Randomized Controlled Trial %A Vadsaria,Khadija %A Nuruddin,Rozina %A Mohammed,Nuruddin %A Azam,Iqbal %A Sayani,Saleem %+ Department of Community Health Sciences, Aga Khan University, Stadium Road, PO Box 3500, Karachi, 74800, Pakistan, 92 34930051 ext 4833, rozina.nuruddin@aku.edu %K calcium %K folic acid %K iron %K mobile health intervention %K micronutrient deficiencies %K Pakistan %K pregnancy %K supplement use %K vitamin D %K artificial intelligence %D 2025 %7 9.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Micronutrient deficiencies in folate, ferritin, calcium, and vitamin D are common during pregnancy in low- and middle-income countries, often due to inadequate diets. Micronutrient supplementation can address this need, whereas innovative awareness strategies in antenatal practices could enhance supplement use compliance. Objective: We evaluated the efficacy of a personalized mobile health (mHealth) intervention, hypothesizing a 30% improvement in supplement use in the intervention group compared to a conventional face-to-face counseling group. Methods: In an unblinded randomized controlled trial, we enrolled 306 first-trimester pregnant women from Aga Khan University Hospital between January 2020 and September 2021 who owned smartphones with internet connection. Women on regular medications or with dietary restrictions or critical illnesses were excluded. The intervention group received personalized micronutrient supplement use coaching through an mHealth app (PurUmeed Aaghaz) as thrice-a-week push messages and tailored recommendations over a 24-week period. The comparison group received standard face-to-face counseling at 6, 12, 18, and 24 weeks after enrollment. Baseline sociodemographic, obstetrics, anthropometric, dietary, and lifestyle data were collected through face-to-face interviews. At each follow-up, participants reported their weekly use of folic acid, iron, calcium, and vitamin D supplements, scored as 0 (daily), 1.5 (4-6 times weekly), and 3 (≤3 times weekly). Scores were summed to calculate the cumulative supplement use score (CSUS; 0-12), with higher scores indicating greater inadequacy. Every fourth woman was invited for biochemical micronutrient assessment. Data were analyzed using Stata (version 14), with random-effects linear and logistic panel regression to compare CSUS and supplement use between the 2 groups from baseline to endline. Results: Of 153 participants per group, 107 (69.9%) in the intervention and 125 (81.7%) in the nonintervention group completed the study. After 24 weeks, the intervention group showed a greater but insignificant reduction in mean CSUS compared to the nonintervention group (β=–.27, 95% CI −0.65 to 0.12; P=.17). Daily supplement use improved by 20% versus 22.4% for folic acid, 11.2 times versus 2.1 times for iron, 1.2 times versus 14.2 times for calcium, and 3 times versus 1.3 times for vitamin D in the intervention versus nonintervention group, respectively. Multivariable analysis showed higher, though insignificant, odds of sufficient folic acid (adjusted odds ratio [aOR] 1.26, 95% CI 0.68-2.36; P=.46) and iron (aOR 1.31, 95% CI 0.95-1.81; P=.10) use in the intervention group, whereas vitamin D use was significantly higher (aOR 1.88, 95% CI 1.43-2.47; P<.001). Calcium intake improved in the nonintervention group (aOR 0.59, 95% CI 0.44-0.79; P<.001). Anemia decreased in the intervention group, whereas ferritin, calcium, and vitamin D deficiencies persisted or worsened, particularly in the nonintervention group. Conclusions: An appropriately implemented mHealth intervention can improve antenatal vitamin D supplementation. Affordable, accessible, and personalized counseling through mHealth could ameliorate micronutrient status during pregnancy. Trial Registration: ClinicalTrials.gov NCT04216446; https://clinicaltrials.gov/study/NCT04216446 %M 40203301 %R 10.2196/67166 %U https://www.jmir.org/2025/1/e67166 %U https://doi.org/10.2196/67166 %U http://www.ncbi.nlm.nih.gov/pubmed/40203301 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e65889 %T Co-Designing a Web-Based and Tablet App to Evaluate Clinical Outcomes of Early Psychosis Service Users in a Learning Health Care Network: User-Centered Design Workshop and Pilot Study %A Burch,Kathleen E %A Tryon,Valerie L %A Pierce,Katherine M %A Tully,Laura M %A Ereshefsky,Sabrina %A Savill,Mark %A Smith,Leigh %A Wilcox,Adam B %A Hakusui,Christopher Komei %A Padilla,Viviana E %A McNamara,Amanda P %A Kado-Walton,Merissa %A Padovani,Andrew J %A Miller,Chelyah %A Miles,Madison J %A Sharma,Nitasha %A Nguyen,Khanh Linh H %A Zhang,Yi %A Niendam,Tara A %+ Department of Psychiatry & Behavioral Sciences, University of California-Davis, 4701 X St, Sacramento, CA, 95817, United States, 1 916 699 5193, knye@ucdavis.edu %K eHealth %K user-centered design %K learning health system %K psychosis %K early psychosis %K user-driven development %K web-based %K data visualization %K surveys and questionnaires %K measurement-based care %D 2025 %7 9.4.2025 %9 Original Paper %J JMIR Hum Factors %G English %X Background: The Early Psychosis Intervention Network of California project, a learning health care network of California early psychosis intervention (EPI) programs, prioritized incorporation of community partner feedback while designing its eHealth app, Beehive. Though eHealth apps can support learning health care network data collection aims, low user acceptance or adoption can pose barriers to successful implementation. Adopting user-centered design (UCD) approaches, such as incorporation of user feedback, prototyping, iterative design, and continuous evaluation, can mitigate these potential barriers. Objective: We aimed to use UCD during development of a data collection and data visualization web-based and tablet app, Beehive, to promote engagement with Beehive as part of standard EPI care across a diverse user-base. Methods: Our UCD approach included incorporation of user feedback, prototyping, iterative design, and continuous evaluation. This started with user journey mapping to create storyboards, which were then presented in UCD workshops with service users, their support persons, and EPI providers. We incorporated feedback from these workshops into the alpha version of Beehive, which was also presented in a UCD workshop. Feedback was again incorporated into the beta version of Beehive. We provided Beehive training to 4 EPI programs who then piloted Beehive’s beta version. During piloting, service users, their support persons, and EPI program providers completed Beehive surveys at enrollment and every 6 months after treatment initiation. To examine preliminary user acceptance and adoption during the piloting phase, we assessed rates of participant enrollment and survey completion, with a particular focus on completion of a prioritized survey: the Modified Colorado Symptom Index. Results: UCD workshop feedback resulted in the creation of new workflows and interface changes in Beehive to improve the user experience. During piloting, 48 service users, 42 support persons, and 72 EPI program providers enrolled in Beehive. Data were available for 88% (n=42) of service users, including self-reported data for 79% (n=38), collateral-reported data for 42% (n=20), and clinician-entered data for 17% (n=8). The Modified Colorado Symptom Index was completed by 54% (n=26) of service users (total score: mean 24.16, SD 16.81). In addition, 35 service users had a support person who could complete the Modified Colorado Symptom Index, and 56% (n=19) of support persons completed it (mean 26.71, SD 14.43). Conclusions: Implementing UCD principles while developing the Beehive app resulted in early workflow changes and produced an app that was acceptable and feasible for collection of self-reported clinical outcomes data from service users. Additional support is needed to increase collateral-reported and clinician-entered data. %M 40203298 %R 10.2196/65889 %U https://humanfactors.jmir.org/2025/1/e65889 %U https://doi.org/10.2196/65889 %U http://www.ncbi.nlm.nih.gov/pubmed/40203298 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e60531 %T Centering Youth Voice in the Adaptation of an mHealth Intervention for Young Adults With HIV in South Texas, United States: Human-Centered Design Approach %A Ho,Nhat Minh %A Johnson,Catherine %A Chidester,Autumn %A Viera Corral,Ruby %A Ramos,Jacundo %A Garcia,Miguel %A Gonuguntla,Rishi %A Cote,Cyrena %A Chandramohan,Divya %A Lin,Hueylie %A Taranova,Anna %A Nijhawan,Ank E %A Kools,Susan %A Ingersoll,Karen %A Dillingham,Rebecca %A Taylor,Barbara S %K HIV %K implementation science %K youth %K mHealth %K adherence %K young %K mobile health %K mobile health intervention %K AIDS %K US %K adult %K self-efficacy %K willingness %K health outcomes %K mHealth intervention %K interview %K human-centered design %K acceptability %K usability %K mobile phone %D 2025 %7 8.4.2025 %9 %J JMIR Form Res %G English %X Background: Young adults living with HIV are less likely to engage in care and achieve viral suppression, compared to other age groups. Young adults living with HIV also have a high degree of self-efficacy and willingness to adopt novel care modalities, including mobile health (mHealth) interventions. Interventions to increase care engagement could aid young adults living with HIV in overcoming structural and social barriers and leveraging youth assets to improve their health outcomes. Objective: The objective of the paper was to use an assets-based framework, positive youth development, and human-centered design principles to adapt an existing mHealth intervention, PositiveLinks (PL), to support care engagement for 18‐ to 29-year-olds with HIV. Methods: We conducted a formative evaluation including semistructured interviews with 14 young adults with HIV and focus groups with 26 stakeholders (providers, nurses, case managers, and clinic staff). Interviews covered barriers to care, provider communication, and concerns or suggestions about mHealth interventions. The research team used thematic analysis to review interview transcripts. In the second phase, human-centered design processes informed adaptation of the existing PL platform using data from real-time use suggestions of 3 young adults with HIV. Throughout the formative evaluation and adaptation, a Youth Advisory Board (YAB) provided input. Results: Young adults with HIV and stakeholders identified common elements of an mHealth intervention that would support care engagement including: the convenience of addressing needs through the app, online support groups to support interconnection, short videos or live chats with other young adults with HIV or providers, appointment and medication reminders, and medical information from a trustworthy source. Stakeholders also mentioned the need for youth empowerment. Concerns included worries about confidentiality, unintentional disclosures of status, urgent content in an unmoderated forum, and the impersonality of online platforms. Design suggestions from young adults with HIV included suggestions on appearance, new formatting for usability of the online support group, and prioritization of local content. Based on the feedback received, iterative changes were made to transform PL into Positive Links for Youth (PL4Y). Final votes on adaptations were made by the YAB. The overall appearance of the platform was changed, including logo, color, and font. The online support group was divided into 3 channels which support hashtags and content searches. The “Resources” and “Frequently Asked Questions” sections were condensed and revised to prioritize South Texas–specific content. Conclusions: Our assets-based framework supported young adults with HIV and stakeholder input in the transformation of an mHealth intervention to meet the needs of 18- to 29-year-olds in South Texas. The human-centered design approach allowed young adults with HIV to suggest specific changes to the intervention’s design to support usability and acceptability. This adapted version, PL4Y, is now ready for pilot testing in the final phase of this implementation science project. %R 10.2196/60531 %U https://formative.jmir.org/2025/1/e60531 %U https://doi.org/10.2196/60531 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e72469 %T Chatbot to Support the Mental Health Needs of Pregnant and Postpartum Women (Moment for Parents): Design and Pilot Study %A McAlister,Kelsey %A Baez,Lara %A Huberty,Jennifer %A Kerppola,Marianna %K perinatal support %K human-centered design %K digital health %K maternal health %K chatbot %K digital tool %D 2025 %7 8.4.2025 %9 %J JMIR Form Res %G English %X Background: Maternal mental health disorders are prevalent, yet many individuals do not receive adequate support due to stigma, financial constraints, and limited access to care. Digital interventions, particularly chatbots, have the potential to provide scalable, low-cost support, but few are tailored specifically to the needs of perinatal individuals. Objective: This study aimed to (1) design and develop Moment for Parents, a tailored chatbot for perinatal mental health education and support, and (2) assess usability through engagement, usage patterns, and user experience. Methods: This study used a human-centered design to develop Moment for Parents, a rules-based chatbot to support pregnant and postpartum individuals. In phase 1, ethnographic interviews (n=43) explored user needs to inform chatbot development. In phase 2, a total of 108 pregnant and postpartum individuals were recruited to participate in a pilot test and had unrestricted access to the chatbot. Engagement was tracked over 8 months to assess usage patterns and re-engagement rates. After 1 month, participants completed a usability, relevance, and satisfaction survey, providing key insights for refining the chatbot. Results: Key themes that came from the ethnographic interviews in phase 1 included the need for trusted resources, emotional support, and better mental health guidance. These insights informed chatbot content, including mood-based exercises and coping strategies. Re-engagement was high (69/108, 63.9%), meaning users who had stopped interacting for at least 1 week returned to the chatbot at least once. A large proportion (28/69, 40.6%) re-engaged 3 or more times. Overall, 28/30 (93.3%) found the chatbot relevant for them, though some noted repetitive content and limited response options. Conclusions: The Moment for Parents chatbot successfully engaged pregnant and postpartum individuals with higher-than-typical retention and re-engagement patterns. The findings underscore the importance of flexible, mood-based digital support tailored to perinatal needs. Future research should examine how intermittent chatbot use influences mental health outcomes and refine content delivery to enhance long-term engagement and effectiveness. %R 10.2196/72469 %U https://formative.jmir.org/2025/1/e72469 %U https://doi.org/10.2196/72469 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 11 %N %P e67108 %T Digital Health Intervention to Reduce Malnutrition Among Individuals With Gastrointestinal Cancer Receiving Cytoreductive Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy: Feasibility, Acceptability, and Usability Trial %A Lin,Yu Chen %A Hagen,Ryan %A Powers,Benjamin D %A Dineen,Sean P %A Milano,Jeanine %A Hume,Emma %A Sprow,Olivia %A Diaz-Carraway,Sophia %A Permuth,Jennifer B %A Deneve,Jeremiah %A Alishahi Tabriz,Amir %A Turner,Kea %K gastrointestinal cancer %K peritoneal disease %K cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy %K digital health intervention %K nutrition %K feasibility %D 2025 %7 7.4.2025 %9 %J JMIR Cancer %G English %X Background: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) can improve survival outcomes for individuals with gastrointestinal (GI) cancer and peritoneal disease (PD). Individuals with GI cancer and PD receiving CRS-HIPEC are at increased risk for malnutrition. Despite the increased risk for malnutrition, there has been limited study of nutritional interventions for individuals receiving CRS-HIPEC. Objective: We aimed to test the feasibility, acceptability, and usability of Support Through Remote Observation and Nutrition Guidance (STRONG), a multilevel digital health intervention to improve nutritional management among individuals with GI cancer and PD receiving CRS-HIPEC. We also assessed patient-reported outcomes, including malnutrition risk, health-related quality of life, and weight-related measures. Methods: STRONG is a 12-week digital intervention in which participants received biweekly nutritional counseling with a dietitian, logged food intake using a Fitbit tracker, and reported nutrition-related outcomes. Dietitians received access to a web-based dashboard and remotely monitored patients’ reported food intake and nutrition-impact symptoms. Implementation outcomes were assessed against prespecified benchmarks consistent with benchmarks used in prior studies. Changes in patient-reported outcomes at baseline and follow-up were assessed using linear and ordered logistic regressions. Results: Participants (N=10) had a median age of 57.5 (IQR 54-69) years. Feasibility benchmarks were achieved for recruitment (10/17, 59% vs benchmark: 50%), study assessment completion (9/10, 90% vs benchmark: 60%), dietitian appointment attendance (7/10, 70% vs benchmark: 60%), daily food intake logging adherence (6/10, 60% vs benchmark: 60%), and participant retention (10/10, 100% vs benchmark: 60%). Most participants rated the intervention as acceptable (8/10, 80% vs benchmark: 70%) and reported a high level of usability for dietitian services (10/10, 100%). The benchmark usability for the Fitbit tracker to log food intake was not met. Compared to baseline, participants saw on average a 6.0 point reduction in malnutrition risk score (P=.01), a 20.5 point improvement in general health-related quality of life score (P=.002), and a 5.6 percentage point increase in 1-month weight change (P=.04) at the end of the study. Conclusions: The STRONG intervention demonstrated to be feasible, acceptable, and usable among individuals with GI cancer and PD receiving CRS-HIPEC. A fully powered randomized controlled trial is needed to test the effectiveness of STRONG for reducing malnutrition and improving patient outcomes. Trial Registration: ClinicalTrials.gov NCT05649969; https://clinicaltrials.gov/study/NCT05649969 %R 10.2196/67108 %U https://cancer.jmir.org/2025/1/e67108 %U https://doi.org/10.2196/67108 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 8 %N %P e59942 %T Identifying Unmet Needs of Informal Dementia Caregivers in Clinical Practice: User-Centered Development of a Digital Assessment Tool %A Biernetzky,Olga A %A Thyrian,Jochen René %A Boekholt,Melanie %A Berndt,Matthias %A Hoffmann,Wolfgang %A Teipel,Stefan J %A Kilimann,Ingo %K unmet needs %K assessment development %K family caregivers of people with dementia %K dementia %K need %K Alzheimer %K self-guided %K self-reported %K caregiver %K informal care %K spousal care %K interview %K qualitative %K thematic %K usability %K mHealth %K tablet %K self-completed %K aging %K patient care %K health interventions %K care giver %K digital health %K ehealth %K digital assessment %K memory %D 2025 %7 7.4.2025 %9 %J JMIR Aging %G English %X Background: Despite the increasing interventions to support family caregivers of people with dementia, service planning and delivery is still not effective. Objective: Our study aimed to develop a digitally-supported needs assessment tool for family caregivers of people with dementia that is feasible, time-efficient, understood by users, and can be self-completed in the primary care setting. Methods: The development of the unmet needs assessment tool was part of a cluster-randomized controlled trial examining the effectiveness of a digitally supported care management programme to reduce unmet needs of family caregivers of people with dementia (GAIN [Gesund Angehörige Pflegen]) and was conducted in 3 phases. Using an iterative participatory approach with informal caregivers, health care professionals including general practitioners, neurologists, psychologists, psychiatrists, nurses, and Alzheimer Society representatives, we developed a digital self-completion unmet needs assessment tool focusing on informal caregivers’ biopsychosocial health und quality of life in connection to their caregiver responsibilities. Data were collected through group discussions, written feedback, protocols, think-aloud protocols, and interviews, and analyzed thematically. Results: Data from 27 caregivers, including caregivers of people with dementia (n=18), health care professionals (n=7), and Alzheimer Society representatives (n=2) were collected. Thematic analysis identified 2 main themes: content of the assessment tool and usability and handling of the digital tablet-based assessment tool. The feedback provided by the stakeholders led to new aspects and changes to make the tool comprehensive, easy to read, and easy to handle. The overall mean completion time was reduced from the initial 37 minutes to 18 minutes, which renders the assessment tool fit to be self-completed in waiting rooms of primary care practices or other settings. Conclusions: The input of the 3 stakeholder groups has supported the development of the assessment tool ensuring that all aspects considered important were covered and understood and the completion of the assessment procedure was time-efficient and practically feasible. Further validation of the assessment tool will be performed with the data generated as part of the GAIN trial. Trial Registration: ClinicalTrials.gov NCT04037501; https://clinicaltrials.gov/study/NCT04037501 %R 10.2196/59942 %U https://aging.jmir.org/2025/1/e59942 %U https://doi.org/10.2196/59942 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e57368 %T Psychological eHealth Interventions for Patients With Cardiovascular Diseases: Systematic Review and Meta-Analysis %A Su,Jing Jing %A Lin,Rose %A Batalik,Ladislav %A Wong,Arkers Kwan Ching %A Grace,Sherry L %+ Elaine C. Hubbard Center for Nursing Research on Aging, School of Nursing, University of Rochester, 255 Crittenden Blvd, Rochester, NY, 14642, United States, 1 (585) 276 6833, sinyirose_lin@urmc.rochester.edu %K cardiovascular diseases %K eHealth %K digital health %K iCBT %K mental health %K psychological intervention %K cognitive behavioral therapy %K CBT %K depression %K heart %K cardiology %K psychological %K anxiety %K high-risk %K systematic review %K meta-analysis %K CVD %K evidence-based %K psychosocial %K GRADE approach %K Cochrane Risk of Bias Tool %K internet-based %K psychological therapy %K psychotherapy %D 2025 %7 7.4.2025 %9 Review %J J Med Internet Res %G English %X Background: Psychological distress is recognized as an independent risk factor for cardiovascular diseases (CVDs), contributing to increased morbidity and mortality. While eHealth is increasingly used to deliver psychological interventions, their effectiveness for patients with CVDs remains unclear. Objective: This meta-analysis aimed to evaluate the effects of eHealth psychological interventions for patients with CVDs. Methods: Eligible studies were retrieved from 5 databases (Embase, Medline, PubMed, CINAHL, and Cochrane Library), covering the period from database inception to December 2024. Randomized controlled trials (RCTs) investigating the effect of evidence-based psychological eHealth interventions to improve psychosocial well-being and cardiovascular outcomes for people with CVDs were included. The Cochrane Risk of Bias tool (version 2) was used to judge the methodological quality of reviewed studies. RevMan (version 5.3) was used for meta-analysis. Results: A total of 12 RCTs, comprising 2319 participants from 10 countries, were included in the review. The results demonstrated significant alleviation of depressive symptoms for patients receiving psychological eHealth intervention compared to controls (number of paper included in that particular analysis, n=7; standardized mean difference=–0.30, 95% CI –0.47 to –0.14; I2=57%; P<.001). More specifically, in 6 trials where internet-based cognitive behavioral therapy was delivered, a significant alleviation of depressive symptoms was achieved (standardized mean difference=–0.39, 95% CI –0.56 to –0.21; I2=53%; P<.001). There was no significant change in anxiety or quality of life. Synthesis without meta-analysis regarding stress, adverse events, and cardiovascular events showed inconclusive findings. Conclusions: Psychological eHealth interventions, particularly internet-based cognitive behavioral therapy, can significantly reduce depressive symptoms among patients with CVDs. A multidisciplinary approach is crucial for comprehensively improving psychological and cardiovascular outcomes. Future studies should explore integrating persuasive design features into eHealth and involving mental health professionals for intervention delivery. Trial Registration: PROSPERO CRD42023452276; https://www.crd.york.ac.uk/PROSPERO/view/CRD42023452276 %M 40194269 %R 10.2196/57368 %U https://www.jmir.org/2025/1/e57368 %U https://doi.org/10.2196/57368 %U http://www.ncbi.nlm.nih.gov/pubmed/40194269 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 8 %N %P e63609 %T Development of a Predictive Dashboard With Prescriptive Decision Support for Falls Prevention in Residential Aged Care: User-Centered Design Approach %A Silva,S Sandun Malpriya %A Wabe,Nasir %A Nguyen,Amy D %A Seaman,Karla %A Huang,Guogui %A Dodds,Laura %A Meulenbroeks,Isabelle %A Mercado,Crisostomo Ibarra %A Westbrook,Johanna I %+ Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, 75 Talavera Road, North Ryde, NSW, 2113, Australia, 61 29850 4045, sandunmalpriya.silva@mq.edu.au %K falls prevention %K dashboard architecture %K predictive %K sustainability %K challenges %K decision support %K falls %K aged care %K geriatric %K older adults %K economic burden %K prevention %K electronic health record %K EHR %K intervention %K decision-making %K patient safety %K risks %K older people %K monitoring %D 2025 %7 7.4.2025 %9 Original Paper %J JMIR Aging %G English %X Background: Falls are a prevalent and serious health condition among older people in residential aged care facilities, causing significant health and economic burdens. However, the likelihood of future falls can be predicted, and thus, falls can be prevented if appropriate prevention programs are implemented. Current fall prevention programs in residential aged care facilities rely on risk screening tools with suboptimal predictive performance, leading to significant concerns regarding resident safety. Objective: This study aimed to develop a predictive, dynamic dashboard to identify residents at risk of falls with associated decision support. This paper provides an overview of the technical process, including the challenges faced and the strategies used to overcome them during the development of the dashboard. Methods: A predictive dashboard was co-designed with a major residential aged care partner in New South Wales, Australia. Data from resident profiles, daily medications, fall incidents, and fall risk assessments were used. A dynamic fall risk prediction model and personalized rule-based fall prevention recommendations were embedded in the dashboard. The data ingestion process into the dashboard was designed to mitigate the impact of underlying data system changes. This approach aims to ensure resilience against alterations in the data systems. Results: The dashboard was developed using Microsoft Power BI and advanced R programming by linking data silos. It includes dashboard views for those managing facilities and for those caring for residents. Data drill-through functionality was used to navigate through different dashboard views. Resident-level change in daily risk of falling and risk factors and timely evidence-based recommendations were output to prevent falls and enhance prescriptive decision support. Conclusions: This study emphasizes the significance of a sustainable dashboard architecture and how to overcome the challenges faced when developing a dashboard amid underlying data system changes. The development process used an iterative dashboard co-design process, ensuring the successful implementation of knowledge into practice. Future research will focus on the implementation and evaluation of the dashboard’s impact on health processes and economic outcomes. International Registered Report Identifier (IRRID): RR2-https://doi.org/10.1136/bmjopen-2021-048657 %M 40193194 %R 10.2196/63609 %U https://aging.jmir.org/2025/1/e63609 %U https://doi.org/10.2196/63609 %U http://www.ncbi.nlm.nih.gov/pubmed/40193194 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e59507 %T Wearable Activity Tracker–Based Interventions for Physical Activity, Body Composition, and Physical Function Among Community-Dwelling Older Adults: Systematic Review and Meta-Analysis of Randomized Controlled Trials %A Li,Ran %A Li,Yangan %A Wang,Lu %A Li,Lijuan %A Fu,Chenying %A Hu,Danrong %A Wei,Quan %+ Department of Rehabilitation Medicine Center and Institute of Rehabilitation Medicine, West China Hospital, Sichuan University, No.37 Guo Xue Xiang, Chengdu, Sichuan, 610041, China, 86 18980606730, weiquan@scu.edu.cn %K wearable activity tracker %K physical activity %K older adult %K systematic review %K meta-analysis %D 2025 %7 3.4.2025 %9 Review %J J Med Internet Res %G English %X Background: The global aging population faces great challenges. Wearable activity trackers have emerged as tools to promote physical activity among older adults, potentially improving health outcomes. However, the effectiveness of such interventions on physical activity, body composition, and physical function among community-dwelling older adults remains debated. Objective: This study conducted a systematic review and meta-analysis to evaluate the impact of wearable activity tracker–based interventions on physical activity, body composition, and physical function among community-dwelling older adults. Methods: We searched the PubMed, Embase, Web of Science, and CENTRAL databases from inception until January 2025 to identify related randomized controlled trials. The outcomes were focused on physical activity (physical activity time, daily step count, and daily sedentary time); body composition (BMI and body fat); and physical function (timed up and go test and chair stand test). Subgroup analysis by different controls (usual care or conventional interventions) and different follow-ups (immediate or short term) were performed. Results: In total 23 trials with 4566 participants were eligible for analysis. Compared to usual care, there was lo- to moderate-certainty evidence that the wearable activity tracker–based interventions significantly increased physical activity time (standardized mean difference [SMD]=0.28, 95% CI 0.10-0.47; P=.003) and daily step counts (SMD=0.58, 95% CI 0.33-0.83; P<.001) immediately after intervention, while no significant improvements were observed in daily sedentary time (mean difference [MD]=−1.56, 95% CI −10.88 to 7.76; I2=0%; P=.74). These interventions were at least as effective as conventional interventions but did not show superiority. Compared with usual care, the interventions using wearable activity trackers only demonstrated a notable increase in daily step count over short-term follow-up (SMD=0.23, 95% CI 0.11-0.36; P<.001). As for body composition and physical function, there was low- to moderate-certainty evidence that the wearable activity tracker–based interventions did not have a greater impact on BMI (MD=0.40, 95% CI −0.08 to 0.89; P=.11), body fat (MD=0.67, 95% CI −0.54 to 1.87; P=.28), the timed up and go test (MD=0.14, 95% CI −0.87 to 1.16; P=.78), or the chair stand test (SMD=−0.31, 95% CI −0.62 to 0; P=.05). Conclusions: This systematic review and meta-analysis indicate that wearable activity tracker–based interventions were effective in enhancing physical activity with low to moderate certainty, but did not significantly impact body composition or physical function, with low to moderate certainty, among community-dwelling older adults, particularly immediately after intervention. This intervention showed a more pronounced impact when compared to usual care, rather than to conventional interventions, with low to moderate certainty. It is important to note that this intervention showed moderate-certainty evidence toward improving daily step count, supporting its sustained impact during short-term follow-up. Trial Registration: PROSPERO CRD42024516900; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024516900 %M 40179387 %R 10.2196/59507 %U https://www.jmir.org/2025/1/e59507 %U https://doi.org/10.2196/59507 %U http://www.ncbi.nlm.nih.gov/pubmed/40179387 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 8 %N %P e66473 %T Older Adults’ Perspectives on Participating in a Synchronous Online Exercise Program: Qualitative Study %A Coletta,Giulia %A Noguchi,Kenneth S %A Beaudoin,Kayla %A McQuarrie,Angelica %A Tang,Ada %A Ganann,Rebecca %A Phillips,Stuart M %A Griffin,Meridith %K exercise %K older adults %K qualitative study %K qualitative %K experience %K attitude %K opinion %K perception %K perspective %K interview %K internet %K kinesiology %K physiotherapy %K synchronous %K online %K home-based %K gerontology %K geriatric %K older %K aging %K physical activity %D 2025 %7 3.4.2025 %9 %J JMIR Aging %G English %X Background: Older adults face several barriers to exercise participation, including transportation, lack of access, and poor weather conditions. Such barriers may influence whether older adults meet the Canadian 24-Hour Movement Guidelines. Recently, older adults have adopted technology for health care and are increasingly using digital health technologies to improve their access to care. Therefore, technology may be a valuable tool to reduce barriers to exercise and increase exercise participation rates within this population. Objective: This study aimed to explore older adults’ perceptions and experiences of exercise, in general, and specifically related to our synchronous online exercise program for community-dwelling older adults. Methods: A total of 3 registered kinesiologists and 1 physiotherapist with experience working with older adults delivered an 8-week, thrice-weekly synchronous online group-based exercise program for older adults in 3 cohorts. The program focused on strength, balance, and aerobic activity. Following the program, a qualitative study with interpretive descriptive design was conducted to explore participants’ perceptions and experiences. Participants were invited to take part in a 30-minute, one-on-one semistructured interview via Zoom with a research team member. Interview data were thematically analyzed to identify common themes. Results: A total of 22 older adults (16 women, 6 men; mean age 70, SD 4 years) participated in interviews. Three themes were identified as follows: (1) health, exercise, and aging beliefs; (2) the pandemic interruption and impacts; and (3) synchronous online exercise programs attenuate barriers to exercise. Participants discussed their exercise beliefs and behaviors and their desire to safely and correctly participate in exercise. Older adults found that their physical activity was curtailed, routines disrupted, and access to in-person exercise programs revoked due to the pandemic. However, many suggested that our synchronous online exercise program was motivational and attenuated commonly reported environmental barriers to participation, such as transportation concerns (eg, time spent traveling, driving, and parking), accessibility and convenience by participating at a location of their choice, and removing travel-related concerns during poor weather conditions. Conclusions: Given these reported experiences, we posit that synchronous online exercise programs may help motivate and maintain adherence to exercise programs for older adults. These findings may be leveraged to improve health outcomes in community-dwelling older adults. Trial Registration: ClinicalTrials.gov NCT04627493; https://clinicaltrials.gov/study/NCT04627493 %R 10.2196/66473 %U https://aging.jmir.org/2025/1/e66473 %U https://doi.org/10.2196/66473 %0 Journal Article %@ 2564-1891 %I JMIR Publications %V 5 %N %P e55248 %T Appropriateness of Web-Based Resources for Home Blood Pressure Measurement and Their Alignment With Guideline Recommendations, Readability, and End User Involvement: Environmental Scan of Web-Based Resources %A Clapham,Eleanor %A Picone,Dean %A Carmichael,Samuel %A Bonner,Carissa %A Chapman,Niamh %+ School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Susan Wakil Health Building, University of Sydney, Western Avenue, Camperdown, Sydney, 2050, Australia, 61 473464291, niamh.chapman@sydney.edu.au %K readability %K online resources %K blood pressure guidelines %K end user %K home blood pressure measurement %K patient education %K educational resource %K self-education %K hypertension %D 2025 %7 3.4.2025 %9 Original Paper %J JMIR Infodemiology %G English %X Background: High blood pressure (≥140/90 mm Hg) is the most prominent mortality risk factor worldwide. Home blood pressure measurement (HBPM) is recommended for blood pressure (BP) management. HBPM is most effective to improve BP management when delivered with patient education. It is unknown whether web-based resources are appropriate for patient education for HBPM. Patient education should provide accurate, evidence-based information, communicate at an eighth grade reading level, and involve end users in development to meet the needs of adults of all health literacy levels. Using these criteria, this study aimed to determine the appropriateness of web-based HBPM resources. Objective: This study aimed to determine whether web-based resources are appropriate for HBPM education based on three research questions: (1) Do web-based resources provide evidence-based information that aligns with guideline recommendations? (2) Do they communicate at an appropriate reading level? (3) Do they involve end users in their development? Methods: An environmental scan of web-based resources for HBPM was conducted on Google (October 2022) using search terms developed with consumers (n=6). Resources were included if they were identified on the first page of the search findings, not paywalled, and in English. Resource appropriateness was appraised based on three criteria: (1) alignment of resource content to 23 recommendations for HBPM from 6 international guidelines, (2) being at an appropriate grade reading level as determined by a health literacy assessment software, and (3) having evidence of end user involvement in resource development. Results: None of the identified resources (n=24) aligned with all 23 of the guideline recommendations. All resources aligned with the recommendation to measure BP when seated, while few aligned with the recommendation to use a validated BP device (n=9, 38%). All resources exceeded the recommended eighth grade reading level (mean 11.8, range 8.8-17.0) and none reported evidence of patient end user involvement in development. Conclusions: None of the web-based resources met the criteria for appropriate education to support adults to measure BP at home. Resources should be developed with end users using health literacy tools and multimodal communication methods to ensure they are appropriate to meet the needs of patients. %M 40179388 %R 10.2196/55248 %U https://infodemiology.jmir.org/2025/1/e55248 %U https://doi.org/10.2196/55248 %U http://www.ncbi.nlm.nih.gov/pubmed/40179388 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e67997 %T A Remote Intervention Based on mHealth and Community Health Workers for Antiretroviral Therapy Adherence in People With HIV: Pilot Randomized Controlled Trial %A Shourya,Shivesh %A Liu,Jianfang %A McInerney,Sophia %A Casimir,Trinity %A Kenniff,James %A Kershaw,Trace %A Batey,David %A Schnall,Rebecca %+ Department of Social and Behavioral Sciences, Yale School of Public Health, 60 College Street, New Haven, CT, 06510, United States, 1 6503346176, shivesh.shourya@yale.edu %K HIV %K antiretroviral therapy adherence %K ART %K ART adherence %K mobile health technology %K mHealth technology %K community health workers %K CHWs %K smart pill bottle %K feasibility evaluation %K mobile health technology acceptance model %D 2025 %7 2.4.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Despite the availability of antiretroviral therapy (ART), only 66% of people with HIV in the United States achieve viral suppression, largely due to suboptimal ART adherence. Barriers such as limited access to care and forgetfulness impact adherence rates, which must be maintained at ≥95% to prevent viral load rebound. Combination interventions leveraging community health worker (CHW) support and mobile health (mHealth) technologies have the potential to overcome previously identified barriers and provide cost-effective support for improving adherence and viral suppression outcomes in people with HIV. Objective: This pilot study aimed to evaluate the feasibility, acceptability, and preliminary efficacy of remote delivery of the Community Health Worker and mHealth to Improve Viral Suppression (CHAMPS) intervention, combining the WiseApp, CHW support, and the CleverCap smart pill bottle. A secondary aim was to gather participants’ feedback on the usability of the app and pill bottle as well as to better understand their experiences with remote study procedures. Methods: This mixed methods pilot study involved 40 participants with HIV, who were randomly assigned to a control group (n=20, 50%) or the CHAMPS intervention (n=20, 50%) over 3 months. The intervention group participated in up to 12 sessions with CHWs and used the WiseApp, paired with a CleverCap smart pill bottle, to support ART adherence. Remote baseline and follow-up visits were conducted via Zoom and included surveys measuring adherence, self-efficacy, and usability (measured by Health Information Technology Usability Evaluation Scale [Health-ITUES] and Poststudy System Usability Questionnaire [PSSUQ]). Semistructured interviews explored participants’ experiences with the intervention. Thematic analysis was used to identify key facilitators and barriers based on the Mobile Health Technology Acceptance Model. Results: Remote delivery of the CHAMPS intervention was feasible, with high usability ratings for both the WiseApp and CleverCap (overall scores on Health-ITUES: mean 4.35, SD 0.58 and PSSUQ: mean 2.04, SD 1.03). In the intervention group, there were nonsignificant improvements in self-reported adherence scores (P=.29) and in self-efficacy scores (P=.07). The adjusted odds ratio for achieving undetectable viral load in the intervention group compared to the control group was 3.01 (95% CI –1.59 to 4.12), indicating a medium effect size in favor of the intervention. Overall study retention was 75% (30/40), with higher retention in the control group. Participants valued the flexibility of remote study procedures, particularly Zoom-based study visits and mailed blood sample kits. Qualitative feedback highlighted the intervention’s acceptability and ability to overcome logistical barriers. Conclusions: The remote CHAMPS pilot study demonstrated the feasibility and acceptability of combining mHealth tools with CHW support to promote medication adherence among people with HIV. While further optimization is needed to enhance its impact, this intervention shows potential for improving health outcomes in diverse underserved populations. Trial Registration: ClinicalTrials.gov NCT05938413; https://clinicaltrials.gov/study/NCT05938413 %M 40173448 %R 10.2196/67997 %U https://formative.jmir.org/2025/1/e67997 %U https://doi.org/10.2196/67997 %U http://www.ncbi.nlm.nih.gov/pubmed/40173448 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 8 %N %P e62841 %T Impact of a 6-Week Postpartum Text Messaging Program (Essential Coaching for Every Mother) at 6 Months: Follow-Up Study to a Randomized Controlled Trial %A Dol,Justine %A Campbell-Yeo,Marsha %A Aston,Megan %A McMillan,Douglas %A Grant,Amy K %K mHealth %K mobile health %K SMS text message %K text messages %K messaging %K self-efficacy %K postpartum depression %K postpartum anxiety %K social support %K intervention %K postpartum %K postnatal %K mental health %K parenting %K mother %K depression %K anxiety %K RCT %K randomized controlled trial %D 2025 %7 2.4.2025 %9 %J JMIR Pediatr Parent %G English %X Background: Essential Coaching for Every Mother is an SMS text messaging program that positively improved parenting self-efficacy and reduced postpartum anxiety when measured immediately after intervention at 6 weeks postpartum. However, the impact of a short-term postpartum intervention over time is unknown. Objective: This study aims to compare parenting self-efficacy, postpartum anxiety symptoms, postpartum depression symptoms, and perceived social support at 6 months postpartum for mothers in the Essential Coaching for Every Mother trial. Methods: Participants (n=150) were randomized to Essential Coaching for Every Mother or control (usual care). Data were collected on parenting self-efficacy (primary outcome, Karitane Parenting Confidence Scale), postpartum anxiety symptoms (Postpartum Specific Anxiety Scale), postpartum depressive symptoms (Edinburgh Postnatal Depression Scale), and perceived social support (Multidimensional Scale of Perceived Social Support) at enrollment and 6-months postpartum. Data were analyzed using analyses of covariance and chi-square analysis. Results: A total of 139 women completed the primary outcome at 6 months and 136 completed secondary outcomes. At 6 months, there were no statistically significant differences between mothers in the intervention group and mothers in the control group on any of the outcomes. More mothers in the intervention group had higher postpartum anxiety scores (31/68, 45.6%) than mothers in the control group (16/68, 23.5%; P=.007). Conclusions: At 6 months postpartum, all mothers had similar scores on parenting self-efficacy, postpartum anxiety symptoms, postpartum depression symptoms, and social support. Thus, Essential Coaching for Every Mother improved parenting self-efficacy and reduced postpartum anxiety at 6 weeks, with all mothers having similar scores at 6 months postpartum. Trial Registration: ClincialTrials.gov NCT04730570; https://clinicaltrials.gov/study/NCT04730570 International Registered Report Identifier (IRRID): RR2-10.2196/27138 %R 10.2196/62841 %U https://pediatrics.jmir.org/2025/1/e62841 %U https://doi.org/10.2196/62841 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e62822 %T Effect of the Yon PD App on the Management of Self-Care in People With Parkinson Disease: Randomized Controlled Trial %A Lee,JuHee %A Yoo,Subin %A Kim,Yielin %A Kim,Eunyoung %A Park,Hyeran %A Sohn,Young H %A Kim,Yun Joong %A Chung,Seok Jong %A Baik,Kyoungwon %A Kim,Kiyeon %A Yoo,Jee-Hye %+ College of Nursing, CHA University, 120 Haeryong-ro, Pocheon-si, 11160, Republic of Korea, 82 31 850 9335, jhyoo2@cha.ac.kr %K Parkinson disease %K mHealth %K mobile health %K app %K neurodegenerative disease %K geriatric %K quality of life %K bradykinesia %K nonmotor symptoms %K self-care %K motor symptoms %K cognitive impairment %K autonomic %K monitoring %K management %K randomized controlled trial %D 2025 %7 2.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: As the percentage of the older population increases, it is accompanied by an increase in the prevalence of Parkinson disease (PD). People with PD experience a range of nonmotor symptoms, including pain, constipation, dysphagia, sleep disturbances, and fatigue. Improving self-care is necessary for people with PD because it is a chronic disease that requires lifelong management. In our previous study, we developed a mobile app (Yon PD app) to monitor nonmotor symptoms of PD. In this study, we investigated the long-term effects of the app in a larger group of people. Objective: This study aimed to examine the effectiveness of a mobile app on the management of self-care in people with PD. Methods: This was a randomized controlled trial. People with PD aged ≥50 years and able to use a smartphone were recruited from the neurology outpatient clinic of a tertiary hospital in South Korea. In total, 102 participants were enrolled in this study. The intervention group was requested to record 5 nonmotor symptoms (pain, constipation, dysphagia, sleep disturbances, and fatigue) for 12 weeks using the mobile app. The control group was requested to record these 5 nonmotor symptoms on a paper questionnaire. General characteristics including age, sex, level of education, disease severity, and comorbidities were examined at baseline. The degree of self-care was examined using the Self-Care of Chronic Illness Inventory at baseline, 6 weeks, and 12 weeks. At 12 weeks, satisfaction with the app was also examined. General characteristics and satisfaction with the app were analyzed using descriptive statistics. The effect of the app on self-care was analyzed using the repeated-measures ANOVA with an α level of .05. Results: In total, 93 participants were included in the analysis. There were 41 and 52 participants in the intervention and control groups, respectively. The general characteristics of the 2 groups were comparable. Monitoring nonmotor symptoms with the app effectively increased self-care maintenance (F2182=4.087; P=.02) and prevented a decrease in self-care monitoring (F2182=3.155; P=.045). However, using the app was ineffective in improving self-care management (F2182=1.348; P=.26). Self-care management gradually decreased over the 12-week period in both groups. The intervention (n=41) adherence rate reached 60.84% at 6 weeks but decreased to 41.87% by 12 weeks. Conclusions: Participants were able to improve the degree of self-care by monitoring their nonmotor symptoms using the app. However, additional strategies that increase motivation and enjoyment are required to improve adherence. Trial Registration: Clinical Research Information Service KCT0006433; https://tinyurl.com/3vmf435m %M 40173440 %R 10.2196/62822 %U https://www.jmir.org/2025/1/e62822 %U https://doi.org/10.2196/62822 %U http://www.ncbi.nlm.nih.gov/pubmed/40173440 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e54062 %T Evaluation of an Online-Based Self-Help Program for Patients With Panic Disorder: Randomized Controlled Trial %A Lalk,Christopher %A Väth,Teresa %A Hanraths,Sofie %A Pruessner,Luise %A Timm,Christina %A Hartmann,Steffen %A Barnow,Sven %A Rubel,Julian %+ Clinical Psychology and Psychotherapy of Adulthood, Institute of Psychology, University Osnabrück, Lise-Meitner-Straße 3, Osnabrück, 49076, Germany, 49 541 969 76, christopher.lalk@uni-osnabrueck.de %K internet-based CBT %K agoraphobia %K well-being %K iCBT %K internet-based intervention %K panic disorder with and without agoraphobia %K panic disorder %K self-help %K quality of life %K effectiveness %K online %K self-help intervention %K panic symptoms %K well-being %K daily functioning %D 2025 %7 2.4.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Panic disorder is an anxiety disorder marked by severe fear of panic attacks in the absence of causes. Agoraphobia is a related anxiety disorder, which involves fear and avoidance of specific situations in which escape or help may be difficult. Both can be debilitating and impair well-being. One treatment option may be internet-based cognitive behavioral therapy (iCBT), which allows large-scale application and may overcome treatment barriers for some individuals. Objective: This study aimed to evaluated the effectiveness of a novel online self-help intervention for panic disorder with or without agoraphobia. As our primary hypotheses, we expected the intervention to improve panic and agoraphobia symptoms and well-being. Our secondary hypotheses entailed improvements in daily functioning, mental health literacy, working ability, and health care use in the intervention group. Methods: German-speaking patients (N=156) aged 18-65 years with internet access and a diagnosis of panic disorder with or without agoraphobia were recruited for this randomized controlled trial. The intervention group (n=82) received access to a 12-week online self-help program entailing psychoeducation, cognitive restructuring, exposure, and mindfulness elements. The control group (n=72) received care as usual during the study period and was offered the prospect of using the program after 12 weeks. The primary outcomes were assessed via the Panic and Agoraphobia Scale (PAS) and the WHO (World Health Organization)-5 Well-Being Index (WHO-5). Mixed effect models were computed using multivariate imputation by chained equation for the analysis of intervention effects. Results: In the intervention group, participants completed on average 7.3 out of 12 (60.8%) modules, and 27 out of 82 (32.1%) participants finished the whole course. Changes in PAS revealed a significant effect in favor of the intervention group (t110.1=–2.22, Padj=.03) with a small to moderate effect size (d=–0.37, 95% CI –0.70 to –0.04). No significant effect was found for the second primary outcome WHO-5 (t149.8=1.35, Padj=.09) or the secondary outcomes. Improvements were observed in anxiety (t206.8=–4.12; P<.001; Cohen d=–0.60, 95% CI –0.089 to –0.32) and depression (t257.4=–3.20; P<.001; Cohen d=–0.41 95% CI –0.66 to –0.16). No negative effects were associated with the intervention (t125=–1.14, P=.26). Conclusions: The presented online intervention can help reduce the core symptomatology of panic disorder and agoraphobia, as well as anxiety symptoms and associated depression. No effects were found for well-being and secondary outcomes. This may be due to higher illness burden in the intervention group and possibly the COVID pandemic, which caused unique challenges to patients suffering from panic disorder. Therefore, further research and intervention adaptations may be warranted to improve these outcomes. Trial Registration: German Clinical Trials Register DRKS00023800; https://drks.de/search/en/trial/DRKS00023800 %M 40173444 %R 10.2196/54062 %U https://www.jmir.org/2025/1/e54062 %U https://doi.org/10.2196/54062 %U http://www.ncbi.nlm.nih.gov/pubmed/40173444 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e73174 %T Authors’ Reply: Balancing Challenges and Opportunities When Evaluating Remote Rehabilitation for Sarcopenia in Older Adults %A Zhang,Lu %A Ge,Ying %A Zhao,Wowa %A Shu,Xuan %A Kang,Lin %A Wang,Qiumei %A Liu,Ying %+ Department of Rehabilitation Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 1, Shuai Fu Yuan Hutong, Dongcheng District, Beijing, 100730, China, 86 18612671468, pumch9887@163.com %K telerehabilitation %K elderly %K sarcopenia %K resistance exercise %K rehabilitation %K gerontology %K aging %K randomized controlled trial %K rehabilitation training %K body composition %K strength %K balance %K cardiorespiratory endurance %K self-care %K physical therapy %D 2025 %7 1.4.2025 %9 Authors' Reply %J J Med Internet Res %G English %X %M 40168657 %R 10.2196/73174 %U https://www.jmir.org/2025/1/e73174 %U https://doi.org/10.2196/73174 %U http://www.ncbi.nlm.nih.gov/pubmed/40168657 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e71845 %T Balancing Challenges and Opportunities When Evaluating Remote Rehabilitation for Sarcopenia in Older Adults %A Zhang,Hao %A Liu,Xiangjie %+ Department of Geriatrics, Liyuan Hospital, Tongji Medical College, Huazhong University of Science and Technology, liuxiangjie1968@126.com, Wuhan, 430077, China, 86 15207461880, liuxiangjie1968@126.com %K telerehabilitation %K elderly %K sarcopenia %K resistance exercise %K rehabilitation %K gerontology %K aging %K randomized controlled trial %K rehabilitation training %K body composition %K strength %K balance %K cardiorespiratory endurance %K self-care %K physical therapy %D 2025 %7 1.4.2025 %9 Letter to the Editor %J J Med Internet Res %G English %X %M 40168660 %R 10.2196/71845 %U https://www.jmir.org/2025/1/e71845 %U https://doi.org/10.2196/71845 %U http://www.ncbi.nlm.nih.gov/pubmed/40168660 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 12 %N %P e65356 %T Psychotherapy Access Barriers and Interest in Digital Mental Health Interventions Among Adults With Treatment Needs: Survey Study %A Starvaggi,Isabella %A Lorenzo-Luaces,Lorenzo %+ , Indiana University Bloomington, 1101 E 10th St, Bloomington, IN, 47405, United States, 1 (812) 855 2012, irstarva@iu.edu %K psychotherapy %K internet-based cognitive behavior therapy %K internet-based interventions %K guided self-help %K public health %K treatment access barriers %K digital mental health %K treatment attitudes %D 2025 %7 1.4.2025 %9 Original Paper %J JMIR Ment Health %G English %X Background: Digital mental health interventions (DMHIs) are a promising approach to reducing the public health burden of mental illness. DMHIs are efficacious, can provide evidence-based treatment with few resources, and are highly scalable relative to one-on-one face-to-face psychotherapy. There is potential for DMHIs to substantially reduce unmet treatment needs by circumventing structural barriers to treatment access (eg, cost, geography, and time). However, epidemiological research on perceived barriers to mental health care use demonstrates that attitudinal barriers, such as the lack of perceived need for treatment, are the most common self-reported reasons for not accessing care. Thus, the most important barriers to accessing traditional psychotherapy may also be barriers to accessing DMHIs. Objective: This study aimed to explore whether attitudinal barriers to traditional psychotherapy access might also serve as barriers to DMHI uptake. We explored the relationships between individuals’ structural versus attitudinal barriers to accessing psychotherapy and their indicators of potential use of internet-delivered guided self-help (GSH). Methods: We collected survey data from 971 US adults who were recruited online via Prolific and screened for the presence of psychological distress. Participants provided information about demographic characteristics, current symptoms, and the use of psychotherapy in the past year. Those without past-year psychotherapy use (640/971, 65.9%) answered questions about perceived barriers to psychotherapy access, selecting all contributing barriers to not using psychotherapy and a primary barrier. Participants also read detailed information about a GSH intervention. Primary outcomes were participants’ self-reported interest in the GSH intervention and self-reported likelihood of using the intervention if offered to them. Results: Individuals who had used psychotherapy in the past year reported greater interest in GSH than those who had not (odds ratio [OR] 2.38, 95% CI 1.86-3.06; P<.001) and greater self-reported likelihood of using GSH (OR 2.25, 95% CI 1.71-2.96; P<.001). Attitudinal primary barriers (eg, lack of perceived need; 336/640, 52.5%) were more common than structural primary barriers (eg, money or insurance; 244/640, 38.1%). Relative to endorsing a structural primary barrier, endorsing an attitudinal primary barrier was associated with lower interest in GSH (OR 0.44, 95% CI 0.32-0.6; across all 3 barrier types, P<.001) and lower self-reported likelihood of using GSH (OR 0.61, 95% CI 0.43-0.87; P=.045). We found no statistically significant differences in primary study outcomes by race or ethnicity or by income, but income had a statistically significant relationship with primary barrier type (ORs 0.27-3.71; P=.045). Conclusions: Our findings suggest that attitudinal barriers to traditional psychotherapy use may also serve as barriers to DMHI use, suggesting that disregarding the role of attitudinal barriers may limit the reach of DMHIs. Future research should seek to further understand the relationship between general treatment-seeking attitudes and attitudes about DMHIs to inform the design and marketing of DMHIs. %M 40168039 %R 10.2196/65356 %U https://mental.jmir.org/2025/1/e65356 %U https://doi.org/10.2196/65356 %U http://www.ncbi.nlm.nih.gov/pubmed/40168039 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 13 %N %P e64098 %T Digital Health Resilience and Well-Being Interventions for Military Members, Veterans, and Public Safety Personnel: Environmental Scan and Quality Review %A Allen,Rashell R %A Malik,Myrah A %A Aquin,Carley %A Herceg,Lucijana %A Brémault-Phillips,Suzette %A Sevigny,Phillip R %+ School and Clinical Child Psychology, Faculty of Education, University of Alberta, 1121-87 Avenue, Edmonton, AB, T6G2G5, Canada, 1 7804920415, wozniak@ualberta.ca %K public safety personnel %K veteran %K military member %K web-based program %K resources %K resilience %K mobile app %K quality review %K well-being %K military %K environmental %K review %D 2025 %7 1.4.2025 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Accessible mental health care, delivered via mobile apps or web-based services, may be essential for military members, public safety personnel (PSP), and veterans, as they report numerous barriers to seeking in-person care and are at an increased risk for a number of psychological disorders. Objective: We aimed to identify, describe, and evaluate apps, resource banks (RBs), and web-based programs (WBPs), referred to as digital mental health interventions (DMHIs), recommended for military members, PSP, and veterans. A multidimensional and multisystemic view of resilience and well-being were maintained throughout this environmental scan. Methods: Information was gathered from a comprehensive review of peer-reviewed literature, a Google search, and a targeted search of websites relevant to the study populations. DMHIs aimed at supporting resilience or well-being were included in the review, including those published in peer-reviewed articles, and those offered to these populations without research or literature backing their use. Results: In total, 69 DMHIs were identified in this study, including 42 apps, 19 RBs, and 8 WBPs, and were described based on 3 questions related to purpose, strategies, and evidence from the adapted Mobile App Rating Scale and the Mobile App Rating Scale. Each WBP and RB was then reviewed via the adapted Mobile App Rating Scale and each app via the Alberta Rating Index for Apps (ARIA). Overall, 24 (35%) of the DMHIs were recommended for military members, 20 (29%) for PSP, and 41 (59%) for veterans. The most common aim across apps, RBs, and WBPs was to increase happiness and well-being, and the most common strategies were advice, tips, and skills training. In total, 2 apps recommended for military members—PTSD Coach and Virtual Hope Box—received a high rating on the ARIA subscales and have also been trialed in pilot randomized control trial (RCT) and RCT evaluations, respectively, with positive initial results. Similarly, 2 apps recommended for PSP—PeerConnect and R2MR—have been trialed in non-RCT studies, with partially positive outcomes or little to no contradictory evidence and received a high rating on the ARIA. Finally, 2 apps recommended for veteran populations—PTSD Coach and VetChange—received high ratings on the ARIA and have been trialed via pilot-RCT and RCT studies, respectively, with positive outcomes. Conclusions: In conclusion, there is a need for efficacy and effectiveness trials for DMHIs for military members, PSP, and veterans to ensure that they are effectively meeting the population’s needs. While there appears to be many promising DMHIs, further research is needed before these interventions continue to be promoted as effective and widely distributed. %M 40168068 %R 10.2196/64098 %U https://mhealth.jmir.org/2025/1/e64098 %U https://doi.org/10.2196/64098 %U http://www.ncbi.nlm.nih.gov/pubmed/40168068 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e69466 %T Impact of Digital Engagement on Weight Loss Outcomes in Obesity Management Among Individuals Using GLP-1 and Dual GLP-1/GIP Receptor Agonist Therapy: Retrospective Cohort Service Evaluation Study %A Johnson,Hans %A Huang,David %A Liu,Vivian %A Ammouri,Mahmoud Al %A Jacobs,Christopher %A El-Osta,Austen %+ Menwell Ltd (t/a Voy), 1st Level, Bronze Building, 105 Sumner Street, London, SE1 9HZ, United Kingdom, 44 07916948134, hj14789@bristol.ac.uk %K obesity %K weight loss %K semaglutide %K tirzepatide %K digital health %K engagement %K behavior %K coaching %K retrospective study %K service evaluation %D 2025 %7 31.3.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Obesity is a global public health challenge. Pharmacological interventions, such as glucagon-like peptide-1 (GLP-1) receptor agonists (eg, semaglutide) and dual GLP-1/gastric inhibitory polypeptide receptor agonists (eg, tirzepatide), have led to significant weight loss among users. Digital health platforms offering behavioral support may enhance the effectiveness of these medications. Objective: This retrospective service evaluation investigated the impact of engagement with an app-based digital weight loss program on weight loss outcomes among individuals using GLP-1 receptor agonists (semaglutide) and dual GLP-1/gastric inhibitory polypeptide receptor agonists (tirzepatide) in the United Kingdom over 5 months. Methods: Data were collected from the Voy weight loss digital health platform between February 2023 and August 2024. Participants were adults aged 18-75 years with a BMI ≥30 or ≥27.5 kg/m2 with the presence of obesity-related comorbidities who initiated a weight management program involving semaglutide or tirzepatide. Engagement was defined based on attendance at coaching sessions, frequency of app use, and regular weight tracking. Participants were categorized as “engaged” or “nonengaged” accordingly. Weight loss outcomes were assessed over a period of up to 5 months. Statistical analyses included chi-square tests, independent t tests, Kaplan-Meier survival analysis, and calculations of Cohen d for effect sizes. Results: A total of 57,975 participants were included in the analysis, with 31,407 (54.2%) classified as engaged and 26,568 (45.8%) as nonengaged. Engaged participants achieved significantly greater weight loss at each time point. At month 3, engaged participants had a mean weight loss of 9% (95% CI 9% to 9.1%) compared with 5.9% (95% CI 5.9% to 6%) in nonengaged participants (P<.001), representing a mean difference of 3.1 percentage points (95% CI 3.1% to 3.1%). A Cohen d effect size of 0.89 indicated a large effect. At month 5, engaged participants had a mean weight loss of 11.53% (95% CI 11.5% to 11.6%) compared with 8% (95% CI 7.9% to 8%) in the nonengaged participants (P<.001). A Cohen d effect size of 0.56 indicated a moderate effect. Participants using tirzepatide achieved more significant weight loss than those using semaglutide at month 5 (13.9%, 95% CI 13.5% to 14.3% vs 9.5%, 95% CI 9.2% to 9.7%; P<.001). The proportion of engaged participants achieving ≥5%, ≥10%, and ≥15% weight loss was significantly higher than the nonengaged group at corresponding time points from months 3 to 5 respectively (P<.001). Conclusions: Engagement with a digital weight management platform significantly enhances weight loss outcomes among individuals using GLP-1 receptor agonists. The combination of pharmacotherapy and digital behavioral support offers a promising strategy to promote the supported self-care journey of individuals seeking clinically effective obesity management interventions. %M 40164173 %R 10.2196/69466 %U https://www.jmir.org/2025/1/e69466 %U https://doi.org/10.2196/69466 %U http://www.ncbi.nlm.nih.gov/pubmed/40164173 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e67539 %T Effectiveness of the Safe Step Digital Exercise Program to Prevent Falls in Older Community-Dwelling Adults: Randomized Controlled Trial %A Pettersson,Beatrice %A Lundin-Olsson,Lillemor %A Skelton,Dawn A %A Liv,Per %A Zingmark,Magnus %A Rosendahl,Erik %A Sandlund,Marlene %+ , Department of Community Medicine and Rehabilitation, Umeå University, Universitetstorget 4, Umeå, 90187, Sweden, 46 907865224, beatrice.pettersson@umu.se %K geriatric medicine %K aging %K accidental falls %K independent living %K exercise therapy %K fall prevention %K electronic health %K mobile health %K preventive medicine %K self-management %K effectiveness %K randomized controlled trial %K older adults %K digital technology %D 2025 %7 31.3.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Falls among older adults are a significant public health issue due to their high incidence, severe consequences, and substantial economic impact. Exercise programs incorporating balance and functional exercises have been shown to reduce fall rates, but adherence and scaling up the interventions remain challenges. Digital technology offers a promising avenue to deliver this type of exercise, potentially improving exercise adherence and enabling self-management of exercise in the aging population. Objective: This study aims to assess the effectiveness of the Safe Step app, a self-managed, unsupervised, home-based digital exercise program, in reducing fall rates or fall risk in community-dwelling older adults. Additional aims were to describe fall-related injuries in both the exercise and control groups, study attrition, and adherence to the Safe Step exercise program. Methods: Community-dwelling individuals, aged 70 years or older, who had experienced falls or a decline in balance in the past year were randomized to either an exercise group using the Safe Step app combined with educational videos, or a control group receiving educational videos alone. Both interventions lasted for 1 year. Information regarding fall events was self-reported monthly through questionnaires. Exercise adherence was monitored through questionnaires every third month. Negative binomial and logistic regression estimated the incidence rate ratio of fall rate and the risk ratio (RR) of experiencing falls, respectively. Fall-related injuries, study attrition, and exercise adherence were reported descriptively. Results: In total, 1628 people were enrolled in the study, 79% were women, and the mean age was 75.8 (SD 4.4) years (range 70-94 years). The intention-to-treat analysis showed no significant difference in fall rates between the exercise and control groups after 12 months (2.21 falls per person-year in the exercise group and 2.41 in the control group; incidence rate ratio 0.92, 95% CI 0.76-1.11; P=.37). The risk of experiencing at least 1 fall was significantly lower (11%) in the exercise group compared to the control group (53% vs 59.6%; RR 0.89, 95% CI 0.80-0.99; P=.03). No differences were observed regarding the risk of 2 or more falls (34.1% in the exercise group, 37.1% in the control group; RR 0.92, 95% CI 0.79-1.06; P=.23). Injurious fall rates were similar between the exercise and control group. During the trial, 161 (20%) participants from the exercise group and 63 (8%) from the control group formally withdrew. The proportion of exercise group participants meeting the 90-minute weekly exercise goal was 12.7%, 13.4%, 8.6%, and 9.1% at 3, 6, 9, and 12 months, respectively. Conclusions: Access to a self-managed unsupervised digital exercise program can be an effective component of a primary fall prevention strategy for community-dwelling older adults. Further research is needed to explore the mediating factors that influence the outcomes and develop strategies that enhance adherence for optimal impact in this population. Trial Registration: ClinicalTrials.gov NCT03963570; https://clinicaltrials.gov/study/NCT03963570 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2019-036194 %M 40163860 %R 10.2196/67539 %U https://www.jmir.org/2025/1/e67539 %U https://doi.org/10.2196/67539 %U http://www.ncbi.nlm.nih.gov/pubmed/40163860 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e63168 %T Digital Health Intervention Effect on Older Adults With Chronic Diseases Living Alone: Systematic Review and Meta-Analysis of Randomized Controlled Trials %A Park,Yoonseo %A Kim,Eun-Ji %A Park,Sewon %A Lee,Munjae %+ Department of Medical Science, School of Medicine, Ajou University, 206, World cup-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16499, Republic of Korea, 82 031 219 5289, emunjae@ajou.ac.kr %K digital health %K chronic diseases %K older adults %K independent living %K aging %K chronic disease %K living alone %K self-management %K medical cost %K cost management %K health promotion %K effectiveness %K quality of life %K physical activity %K health care %K health informatics %K systematic review %K meta-analysis %K PRISMA %D 2025 %7 31.3.2025 %9 Review %J J Med Internet Res %G English %X Background: The incidence of chronic diseases is increasing owing to the aging population; in particular, older adults living alone struggle with self-management and medical expenses. Digital health can contribute to medical cost management and health promotion, but its effectiveness for older adults living alone remains unclear. In a rapidly aging society, it is important to demonstrate the effect of digital health on improving the lives of older adults living alone and reducing the burden of chronic diseases. Objective: This study aims to examine the intervention effects of digital health on self-management, quality of life, and medical factors for older adults living alone with common chronic diseases such as cardiovascular disease, respiratory disease, and musculoskeletal disorders through a systematic literature review and meta-analysis. Methods: We searched the literature using 3 databases, including PubMed, CINAHL, and Cochrane CENTRAL, for literature published in overseas academic journals up to October 2024. The final 11 papers were used for analysis based on selection and exclusion criteria. Meta-analysis was used to calculate the mean difference and standardized mean difference (SMD) for the selected literature using RevMan (version 5.4; Cochrane). The effect size and heterogeneity were calculated through 95% CI. Results: As a result of conducting a meta-analysis of 8 of 11 documents, there was a significant effect of self-management factors on moderate-to-vigorous physical activity (SMD=0.08; z=2.07; P=.04). However, among self-management factors, low-density lipoprotein cholesterol (SMD=–0.04; z=0.91; P=.36) did not show statistically significant results. Among the medical factors, general quality of life (SMD=0.11; z=0.93; P=.35), depression (SMD=–3.95; z=1.59; P=.11), and hospital days (SMD=–1.57; z=0.91; P=.36) also did not show statistically significant results. However, it was confirmed that they improved after a digital health intervention. Conclusions: This study demonstrated that digital health interventions are effective in improving physical activity in older adults with chronic diseases living alone. However, owing to the characteristics of older adults living alone, there is a need to further expand digital health to combine care services that can manage diseases at home. %M 40163849 %R 10.2196/63168 %U https://www.jmir.org/2025/1/e63168 %U https://doi.org/10.2196/63168 %U http://www.ncbi.nlm.nih.gov/pubmed/40163849 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 9 %N %P e58124 %T Acceptability of a Web-Based Health App (PortfolioDiet.app) to Translate a Nutrition Therapy for Cardiovascular Disease in High-Risk Adults: Mixed Methods Randomized Ancillary Pilot Study %A Kavanagh,Meaghan E %A Chiavaroli,Laura %A Quibrantar,Selina M %A Viscardi,Gabrielle %A Ramboanga,Kimberly %A Amlin,Natalie %A Paquette,Melanie %A Sahye-Pudaruth,Sandhya %A Patel,Darshna %A Grant,Shannan M %A Glenn,Andrea J %A Ayoub-Charette,Sabrina %A Zurbau,Andreea %A Josse,Robert G %A Malik,Vasanti S %A Kendall,Cyril W C %A Jenkins,David J A %A Sievenpiper,John L %+ Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, C. David Naylor Building, Room 201, 6 Queen’s Park Crescent, Toronto, ON, M5S 3H2, Canada, 1 416 867 3732, john.sievenpiper@utoronto.ca %K diet %K apps %K dietary app %K Portfolio Diet %K dietary portfolio %K cholesterol reduction %K cardiovascular disease %K eHealth %K usability %K acceptability %D 2025 %7 28.3.2025 %9 Original Paper %J JMIR Cardio %G English %X Background: The Portfolio Diet is a dietary pattern for cardiovascular disease (CVD) risk reduction with 5 key categories including nuts and seeds; plant protein from specific food sources; viscous fiber sources; plant sterols; and plant-derived monounsaturated fatty acid sources. To enhance implementation of the Portfolio Diet, we developed the PortfolioDiet.app, an automated, web-based, multicomponent, patient-facing health app that was developed with psychological theory. Objective: We aimed to evaluate the effect of the PortfolioDiet.app on dietary adherence and its acceptability among adults with a high risk of CVD over 12 weeks. Methods: Potential participants with evidence of atherosclerosis and a minimum of one additional CVD risk factor in an ongoing trial were invited to participate in a remote web-based ancillary study by email. Eligible participants were randomized in a 1:1 ratio using a concealed computer-generated allocation sequence to the PortfolioDiet.app group or a control group for 12 weeks. Adherence to the Portfolio Diet was assessed by weighed 7-day diet records at baseline and 12 weeks using the clinical Portfolio Diet Score, ranging from 0 to 25. Acceptability of the app was evaluated using a multifaceted approach, including usability through the System Usability Scale ranging from 0 to 100, with a score >70 being considered acceptable, and a qualitative analysis of open-ended questions using NVivo 12. Results: In total, 41 participants were invited from the main trial to join the ancillary study by email, of which 15 agreed, and 14 were randomized (8 in the intervention group and 6 in the control group) and completed the ancillary study. At baseline, adherence to the Portfolio Diet was high in both groups with a mean clinical Portfolio Diet Score of 13.2 (SD 3.7; 13.2/25, 53%) and 13.7 (SD 5.8; 13.7/25, 55%) in the app and control groups, respectively. After the 12 weeks, there was a tendency for a mean increase in adherence to the Portfolio Diet by 1.25 (SD 2.8; 1.25/25, 5%) and 0.19 (SD 4.4; 0.19/25, 0.8%) points in the app and control group, respectively, with no difference between groups (P=.62). Participants used the app on average for 18 (SD 14) days per month and rated the app as usable (System Usability Scale of mean 80.9, SD 17.3). Qualitative analyses identified 4 main themes (user engagement, usability, external factors, and added components), which complemented the quantitative data obtained. Conclusions: Although adherence was higher for the PortfolioDiet.app group, no difference in adherence was found between the groups in this small ancillary study. However, this study demonstrates that the PortfolioDiet.app is considered usable by high-risk adults and may reinforce dietitian advice to follow the Portfolio Diet when it is a part of a trial for CVD management. Trial Registration: ClinicalTrials.gov NCT02481466; https://clinicaltrials.gov/study/NCT02481466 %M 40152922 %R 10.2196/58124 %U https://cardio.jmir.org/2025/1/e58124 %U https://doi.org/10.2196/58124 %U http://www.ncbi.nlm.nih.gov/pubmed/40152922 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e67234 %T Efficacy of a Web-Based Integrated Growth Mindset Intervention on Reducing Anxiety Among Social Work and Counseling Practicum Trainees: Protocol for a 2-Arm Randomized Controlled Trial %A Wang,Yongyi %A Xi,An %A Wong,Stella S K %A Yam,Kong %A Leung,Janet Tsin Yee %A Zhu,Shimin %+ Department of Applied Social Sciences, The Hong Kong Polytechnic University, Room GH348, 11 Yuk Choi Road, Hung Hom, Kowloon, Hong Kong, 999077, China (Hong Kong), 852 27665787, jasmine.zhu@polyu.edu.hk %K implicit theory %K growth mindset %K social work students %K counselling students %K practicum %K anxiety %D 2025 %7 27.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Practicum is indispensable for the development of professional practitioners; yet, trainees may encounter psychological distress, especially anxiety, brought on by new challenges. Research stated that a positive mindset promotes better learning and mental status. Well-designed interventions have been shown to relieve anxiety and help trainees thrive in their practicums and professions. The proposed study adapted an integrated intervention, We-SMILE (Web-Based Single-Session Intervention of Mindset on Intelligence, Failure, and Emotion), for improving prepracticum anxiety and coping. We-SMILE has the potential to be a low-intensity self-help prepracticum intervention to support students in adjusting their mindsets and overcoming the challenges in practicum. Objective: Using a 2-arm randomized controlled trial, this study aims to examine the efficacy of We-SMILE on reducing anxiety (primary outcome) and enhancing psychological status, psychological well-being, learning orientation, academic self-efficacy, and confidence (secondary outcomes). Methods: A total of 117 students will be recruited from the social work and counseling programs and randomly assigned to existing prepracticum training (training as usual [TAU]) or that plus the We-SMILE. Participants will be assessed repeatedly at 3 time points: baseline, 2 weeks post intervention, and 8 weeks post intervention. The outcomes will be measured by validated items and scales on anxiety, mindsets, psychological well-being, and the Failure Mindset Scale. Recruitment for the pilot study was initiated in May 2024 during social work and counseling prepracticum briefing sessions. Participants were randomly assigned to the intervention or TAU group. The intention-to-treat (ITT) analysis principle and linear regression–based maximum likelihood multilevel models will be used for data analysis. Results: This study has received research ethics approval in May 2024. Participant recruitment started at the end of May 2024, and enrollment was ongoing as of when this protocol was submitted. Data collection and analyses are expected to be complete in 2025. Conclusions: The randomized controlled trial will compare the efficacy of the We-SMILE intervention group and the TAU group. The results of this study will benefit practicum students, fieldwork supervisors, and social work and counseling programs. Trial Registration: ClinicalTrials.gov NCT06509802; https://tinyurl.com/36vkwd63 International Registered Report Identifier (IRRID): DERR1-10.2196/67234 %M 40146991 %R 10.2196/67234 %U https://www.researchprotocols.org/2025/1/e67234 %U https://doi.org/10.2196/67234 %U http://www.ncbi.nlm.nih.gov/pubmed/40146991 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 14 %N %P e65863 %T Interactive Effects of Weight Recording Frequency and the Volume of Chat Communication With Health Care Professionals on Weight Loss in mHealth Interventions for Noncommunicable Diseases: Retrospective Observational Study %A Hagiwara,Yuta %A Adachi,Takuji %A Kanai,Masashi %A Shimizu,Kotoe %A Ishida,Shinpei %A Miki,Takahiro %K weight change %K behavior modification %K health care communication %K weight recording %K chat communication %K text communication %K health care professionals %K weight loss %K mHealth %K mobile health %K app %K digital health %K smartphone %K mobile health intervention %K noncommunicable disease %K NCD %K weight loss outcome %K obesity %K overweight %K retrospective study %K observational study %K cerebrovascular disease %K cardiovascular disease %K lifestyle modification %K mobile phone %D 2025 %7 27.3.2025 %9 %J Interact J Med Res %G English %X Background: Mobile health (mHealth) apps are increasingly used for health promotion, particularly for managing noncommunicable diseases (NCDs) through behavior modification. Understanding the factors associated with successful weight loss in such interventions can improve program effectiveness. Objective: This study examined factors influencing weight change and the relationship between weight recording frequency and chat volume with health care professionals on weight loss in individuals with obesity and NCDs. Methods: The participants had obesity (BMI ≥25 kg/m²) and were diagnosed with NCDs (eg, hypertension, diabetes, dyslipidemia). The program included 12 telephone consultations with health care professionals. Only participants who completed the full 6-month program, including all 12 telephone consultations, and provided an end-of-study weight were included in the analysis. The primary outcome was the rate of weight change, defined as the percentage change in weight from the initial period (first 14 days) to the final period (2 weeks before the last consultation), relative to the initial weight. The key independent variables were proportion of days with weight recording and chat communication volume (total messages exchanged). An interaction term between these variables was included to assess moderation effects in the regression analysis. The volume of communication was measured as the total number of messages exchanged, with each message, regardless of who sent it, being counted as 1 interaction. Health care staffs were instructed to send a single scheduled chat message per week following each biweekly phone consultation. These scheduled messages primarily included personalized feedback, reminders, and motivational support. In addition, providers responded to participant-initiated messages at any time during the program. Furthermore, 1 professional responded to each participant. Hierarchical multiple regression and simple slope analyses were conducted to identify relationships and interactions among these variables. Results: The final analysis of this study included 2423 participants. Significant negative associations were found between the rate of weight change and baseline BMI (β=−.10; P<.001), proportion of days with weight recording (β=−.017; P<.001), and communication volume (β=−.193; P<.001). The interaction between proportion of days with weight recording and chat frequency also showed a significantly negative effect on weight change (β=−.01; P<.001). Simple slope analysis showed that when the proportion of days with weight recording was +1 SD above the mean, frequent chats were associated with greater weight reduction (slope=−0.60; P<.001), whereas no significant effect was observed at −1 SD (slope=−0.01; P=.94) Conclusions: The findings suggest that both the proportion of days with weight recording and communication volume independently and interactively influence weight change in individuals with obesity and NCDs. %R 10.2196/65863 %U https://www.i-jmr.org/2025/1/e65863 %U https://doi.org/10.2196/65863 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 14 %N %P e63079 %T Glucagon-Like Peptide-1 Receptor Agonists Combined With Personalized Digital Health Care for the Treatment of Metabolic Syndrome in Adults With Obesity: Retrospective Observational Study %A Zakaria,Hala %A Jabri,Hadoun %A Alshehhi,Sheikha %A Caccelli,Milena %A Debs,Joelle %A Said,Yousef %A Kattan,Joudy %A Almarzooqi,Noah %A Hashemi,Ali %A Almarzooqi,Ihsan %K metabolic syndrome %K obesity %K GLP-1 medications %K hybrid model of care %K digital health %K effectiveness %K digital engagement %K hybrid care %K adult %K cardiovascular disease %K type 2 diabetes %K insulin resistance %K efficacy %K behavioral change %K obese %K zone health %K weight loss %K monitoring %K tirzepatide %K semaglutide %K treatment %K medication %K telehealth %K health informatics %K glucagon-like peptide-1 %D 2025 %7 27.3.2025 %9 %J Interact J Med Res %G English %X Background: Metabolic syndrome (MetS) represents a complex and multifaceted health condition characterized by a clustering of interconnected metabolic abnormalities, including central obesity, insulin resistance, dyslipidemia, and hypertension. Effective management of MetS is crucial for reducing the risk of cardiovascular diseases and type 2 diabetes. Objective: This study aimed to assess the effectiveness of combining glucagon-like peptide-1 (GLP-1) and dual gastric inhibitory polypeptide (GIP)/GLP-1 agonists with a continuous, digitally delivered behavioral change model by an integrated care team, in treating MetS among individuals with obesity. Methods: The 6-month Zone.Health (meta[bolic]) weight loss program involved 51 participants (mean age 45, SD 10 years; mean BMI 35, SD 5 kg/m²), categorized by gender, and treated with either tirzepatide or semaglutide. Participants received continuous support via a digital health platform, which facilitated real time monitoring and personalized feedback from an integrated care team. Engagement levels with the digital platform, measured by the frequency of inbound interactions, were tracked and analyzed in relation to health outcomes. Results: Tirzepatide reduced waist circumference (WC) by −18.08 cm, compared with −13.04 cm with semaglutide (P<.001). Triglycerides decreased significantly with both drugs, with tirzepatide showing a reduction of −64.42 mg/dL and semaglutide −70.70 mg/dL (P<.001). Tirzepatide generally showed more pronounced improvements in fasting glucose, blood pressure (BP), low-density lipoprotein, and total cholesterol compared with semaglutide. Higher engagement with the digital health platform showed significant difference among the 3 groups; the group with the highest level of app-based interactions (≥25 interactions) had the greatest WC reduction (mean −19.04, SD 7.40 cm) compared with those with ≤15 interactions (mean −9.60, SD 5.10 cm; P=.002). Similarly, triglycerides showed the greatest reduction in the group with ≥25 interactions (mean −108.56, SD 77.06 mg/dL) compared with those with ≤15 interactions (mean −44.49, SD 50.85 mg/dL; P=.02). This group also exhibited the largest reduction in diastolic BP (mean −10.33, SD 7.40 mm Hg) compared with those with ≤15 interactions (mean −0.83, SD 7.83 mm Hg; P=.004), and the most substantial decrease in fasting glucose levels (mean −18.60, SD 10.82 mg/dL) compared with those with ≤15 interactions (mean −2.49, SD 27.54 mg/dL; P=.02). Participants in the highest quartile of digital engagement had a 60% greater likelihood of MetS reversal compared with those in the lowest quartile. Conclusions: This study shows that combining GLP-1 and dual GIP/GLP-1 agonists with a digital behavioral change model significantly improves MetS markers in individuals with obesity. Tirzepatide proved more effective than semaglutide, leading to greater reductions in WC and triglyceride levels, along with better improvements in fasting glucose, BP, and lipid profiles. Higher app-based engagement was linked to better health outcomes, with participants in the highest engagement group having a 60% greater likelihood of treating MetS compared with those with the lowest engagement. %R 10.2196/63079 %U https://www.i-jmr.org/2025/1/e63079 %U https://doi.org/10.2196/63079 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e60092 %T Effectiveness of an mHealth- and School-Based Health Education Program for Salt Reduction (EduSaltS) in China: Cluster Randomized Controlled Trial Within Scale-Up %A Wang,Naibo %A Wang,Chen %A Zhang,Puhong %A Li,Yinghua %A He,Feng J %A Li,Li %A Li,Yuan %A Luo,Rong %A Wan,Dezhi %A Xu,Lewei %A Deng,Lifang %A Wu,Lei %+ School of Public Health, Jiangxi Provincial Key Laboratory of Disease Prevention and Public Health, Jiangxi Medical College, Nanchang University, No. 461 Ba Yi Avenue, Donghu District, Jiangxi Province, Nanchang, 330006, China, 86 18970813850, leiwu@ncu.edu.cn %K school-based health education %K EduSaltS %K mobile health %K salt reduction %K cluster randomized trial %D 2025 %7 27.3.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Globally, cardiovascular diseases are leading causes of mortality and disability, with hypertension being a major risk factor. Reducing salt intake and blood pressure are among the most cost-effective health promotion strategies. While mobile health (mHealth)– and school-based salt reduction interventions have proven effective in trials, their impact when scaled up in real-world contexts remains uncertain. Objective: We evaluated the effectiveness of the real-world implementation of an mHealth- and school-based health education scale-up program to reduce salt intake (EduSaltS [mHealth and school-based education program to reduce salt intake scaling up in China]). Methods: A parallel cluster randomized controlled trial was conducted from April 2022 to July 2023 across 20 schools in 2 districts and 2 counties within Ganzhou City, Jiangxi Province, China. Schools were randomized 1:1 to intervention or control groups within each district or county. One third-grade class per school and 26 students per class were randomly sampled. One parent, or alternative family member (aged 18-75 years, residing with the student), of each student was invited to join. The EduSaltS intervention, spanning over 1 academic year, incorporated both app-based health education courses and offline salt reduction activities, with participation monitored through the backend management system. The intervention’s effectiveness was assessed by comparing changes in salt intake and blood pressure between groups from baseline to 1-year follow-up using surveys, physical examination, and 24-hour urine tests. Results: Of 524 children (boys: n=288, 54.96%; age: mean 9.16, SD 0.35 years) and 524 adults (men: n=194, 37.02%; age: mean 40.99, SD 11.04 years) who completed the baseline assessments in 10 intervention and 10 control schools, 13 (2.48%) children and 47 (8.97%) adults were lost to follow-up. All schools and participants showed satisfactory intervention adherence. Measured differences in schoolchildren’s salt intake, systolic blood pressure, and diastolic blood pressure, between the intervention and control schools, were –0.24 g/day (95% CI –0.82 to 0.33), –0.68 mm Hg (95% CI –2.32 to 0.95), and –1.37 mm Hg (95% CI –2.79 to 0.06), respectively. For adults, the intervention group’s salt intake decreased from 9.0 (SE 0.2) g/day to 8.3 (SE 0.2) g/day post intervention. Adjusted changes in the intervention (vs control) group in salt intake, systolic blood pressure, and diastolic blood pressure were –1.06 g/day (95% CI –1.81 to –0.30), –2.26 mm Hg (95% CI –4.26 to –0.26), and –2.33 mm Hg (95% CI –3.84 to –0.82), respectively. Conclusions: The EduSaltS program, delivered through primary schools with a child-to-parent approach, was effective in reducing salt intake and controlling blood pressure in adults, but its effects on children were not significant. While promising for nationwide scaling, further improvements are needed to ensure its effectiveness in reducing salt intake among schoolchildren. Trial Registration: Chinese Clinical Trial Registry ChiCTR2400079893; https://tinyurl.com/4maz7dyv (retrospectively registered); Chinese Clinical Trial Registry ChiCTR2000039767; https://tinyurl.com/5n6hc4s2 %M 40017342 %R 10.2196/60092 %U https://www.jmir.org/2025/1/e60092 %U https://doi.org/10.2196/60092 %U http://www.ncbi.nlm.nih.gov/pubmed/40017342 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e66975 %T Stress and Hypertension Among African American Female Family Caregivers of Persons Living With Alzheimer Disease and Related Dementias: Protocol for a Pilot Internet-Based Randomized Controlled Trial %A Wright,Kathy D %A Richards Adams,Ingrid K %A Helsabeck,Nathan P %A Rose,Karen M %A Moss,Karen O %A Nemati,Donya %A Palmer,Navia %A Kim,Bohyun %A Pokhrel Bhattarai,Sunita %A Nguyen,Christopher %A Addison,Daniel %A Klatt,Maryanna D %+ The Ohio State University College of Nursing, 1577 Neil Avenue, Columbus, OH, 43210, United States, 1 6142920309, wright.2104@osu.edu %K African American women %K high blood pressure %K stress reactivity and resilience %K caregiving %K hypertension %K stress %K Alzheimer disease %K dementia %K lifestyle and healthy self-care behaviors %D 2025 %7 27.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Caregivers of persons with Alzheimer disease and related dementias (ADRD) neglect their health, including by ignoring stress levels. African American women are vulnerable and susceptible to hypertension. Chronic caregiving stress and hypertension place them at high risk for cardiovascular disease. Addressing stress reactivity or resilience is vital in lessening their caregiving stress, enhancing their quality of life (QOL), and fostering healthy blood pressure (BP) self-care behaviors. Objective: This pilot study aims to investigate the feasibility and acceptability of implementing the Mindfulness in Motion (MIM) plus the Dietary Approaches to Stop Hypertension (DASH) intervention in this population and to evaluate its effect on ADRD caregivers’ stress and QOL. Additionally, it explores the mediation of stress reactivity or resilience between interventions and self-care behaviors. Methods: A small randomized controlled trial pilot study will recruit 28 African American or Black female caregivers aged 40 years diagnosed with hypertension and on an antihypertensive medication. Participants will be randomly assigned to either the MIM DASH or the Alzheimer’s Association caregiver training group (attention control). Trained facilitators will deliver both interventions over 8 weeks through 1-hour, group, internet-based sessions, via video or telephone. After completion, both groups will receive coaching calls over 9 months, beginning with 8 weekly calls followed by 4 monthly calls to encourage use of the educational materials. Primary outcome measures include feasibility (recruitment and retention) and acceptability (attendance). Secondary measures assess caregiver stress (Perceived Stress Scale), QOL, and self-care behaviors (Food Frequency Questionnaire and self-reported physical activity). Data collection occurs at baseline, 3 months, and 9 months. Quantitative data will be analyzed using descriptive statistics, CIs, and mediation models. Results: This study was approved by the institutional review board in April 2022 and funded in May 2022. The first data were collected in January 2023, and the last data were collected in September 2024. The completion of all aims’ data analysis is anticipated in spring 2025. The participants’ mean age was 62.4 (SD 7.98) years, with a mean baseline systolic BP of 128 (SD 19) mm Hg and diastolic BP of 79 (SD 10) mm Hg. Participants reported that MIM DASH was acceptable (at a mean score of 59.08, SD 7.38, compared to 60.83, SD 5.56 for caregiver training). Regarding feasibility, as reflected in attendance, MIM DASH participants had a mean attendance of 6.3 (SD 2.3) sessions, and the caregiver training group had 4.9 (SD 2.9) sessions. Conclusions: This study’s findings demonstrate the feasibility of conducting an internet-based intervention (MIM DASH) for African American women with hypertension who also care for families living with ADRD. These results will inform the design of a larger randomized controlled trial to evaluate the intervention’s efficacy and scalability further. Trial Registration: ClinicalTrials.gov NCT05721482; https://clinicaltrials.gov/study/NCT05721482 International Registered Report Identifier (IRRID): DERR1-10.2196/66975 %M 40146982 %R 10.2196/66975 %U https://www.researchprotocols.org/2025/1/e66975 %U https://doi.org/10.2196/66975 %U http://www.ncbi.nlm.nih.gov/pubmed/40146982 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e63822 %T Engaging End Users to Inform the Design and Social Marketing Strategy for a Web-Based Sexually Transmitted Infection/Blood-Borne Virus (STI/BBV) Testing Service for Young People in Victoria, Australia: Qualitative Study %A Cardwell,Ethan T %A Ludwick,Teralynn %A Chang,Shanton %A Walsh,Olivia %A Lim,Megan %A Podbury,Rachel %A Evans,David %A Fairley,Christopher K %A Kong,Fabian Y S %A Hocking,Jane S %+ Melbourne School of Population and Global Health, Centre for Epidemiology and Biostatistics, The University of Melbourne, 207 Bouverie Street, Level 3, Parkville, Australia, 61 3 9035 3039, t.cardwell@unimelb.edu.au %K web-based STI/HIV testing %K social marketing %K sexual health %K participatory design %K codesign %K sexually transmitted infections %K STI %K HIV %K Australia %K social media %K survey %K blood-borne viruses %D 2025 %7 27.3.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: The rates of sexually transmitted infections (STIs) continue to rise across Australia among 16- to 29-year-olds. Timely testing is needed to reduce transmission, but sexual health clinics are at capacity. This demand, coupled with barriers to getting tested faced by young people, has led to web-based services as a pragmatic solution. However, for young people to use these services, they must be acceptable, attractive, and usable. Social marketing principles combined with end user engagement can be used to guide the development of a web-based service and create a marketing strategy to attract them to the service. Objective: Working closely with end users and guided by social marketing, this project explored messaging, design elements (imagery), and promotional strategies that will support high usage of a web-based STI/blood-borne virus (BBV) testing service for young people in Victoria, Australia. Methods: Young people were recruited to participate in half-day workshops via youth organizations and targeted Meta (Facebook/Instagram) advertisements. An initial web-based survey was deployed to inform workshop content. Workshops were held in metropolitan, outer metropolitan, and regional Victoria. Young people were presented with a range of “image territories” developed by a social marketing firm and social marketing messages that were informed by the literature on communicating health messages. Participants discussed the feelings and reactions evoked by the content. Data collected through mixed methods (transcribed notes, audio recording, and physical outputs) were thematically analyzed to understand features of messaging and imagery that would attract young people to use the service. Results: A total of 45 people completed the initial survey with 17 participating in focus group workshops (metropolitan: n=8, outer metropolitan: n=6, and regional: n=3). Young people preferred messages that highlight the functional benefits (confidential, affordable, and accessible) of a web-based service and include professional imagery and logos that elicit trust. Young people indicated that the service should be promoted through digital communications (eg, dating apps and social media), with endorsement from government or other recognized institutions, and via word-of-mouth communications. Conclusions: This study has highlighted the value of applying social marketing theory with end user engagement in developing a web-based STI/BBV testing service. Through the voices of young people, we have established the foundations to inform the design and marketing for Victoria’s first publicly funded web-based STI/BBV testing clinic. Future research will measure the reach and efficacy of social marketing, and how this service complements existing services in increasing STI/BBV testing uptake among young Victorians. %M 40146201 %R 10.2196/63822 %U https://www.jmir.org/2025/1/e63822 %U https://doi.org/10.2196/63822 %U http://www.ncbi.nlm.nih.gov/pubmed/40146201 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e65847 %T Theory-Based Social Media Intervention for Nonmedical Use of Prescription Opioids in Young Adults: Protocol for a Randomized Controlled Trial %A Tam,Cheuk Chi %A Young,Sean D %A Harrison,Sayward %A Li,Xiaoming %A Litwin,Alain H %+ Arnold School of Public Health, University of South Carolina, 921 Assembly Street, Columbia, SC, 29208, United States, 1 8037776883, ctam@mailbox.sc.edu %K nonmedical use of prescription opioids %K opioid misuse %K young adults %K social media %K psychosocial intervention %K randomized controlled trial %K mixed methods %D 2025 %7 26.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: The nonmedical use of prescription opioids (NMUPO) in young adults in the United States is concerning and is robustly influenced by many psychosocial factors. Given the advantages of flexibility, wide coverage, and real-time responses and assessment, using social media appears to be a promising and innovative approach to delivering psychosocial intervention to young adults. However, few theory-based social media interventions are available for NMUPO targeting this at-risk population. Objective: Guided by the information-motivation-behavioral skills model, the proposed research aims to address critical gaps by theoretically exploring psychosocial content associated with NMUPO among young adults via formative assessment. These findings will then be used to develop and evaluate the feasibility and preliminary efficacy of a peer-led social media intervention to reduce NMUPO among young adults. Methods: The proposed study will comprise serial research activities. First, formative research will be conducted through semistructured interviews among 30 young adults engaged in NMUPO. Qualitative data will be synthesized using a pragmatic approach for identifying psychosocial content associated with NMUPO. Second, qualitative findings will be used for developing a peer-led social media intervention to reduce NMUPO among young adults by integrating promising psychotherapy principles and incorporating them with well-trained recovery coaches. Third, the social media intervention will be evaluated through a 12-week randomized controlled trial among 70 young adults (n=35, 50% in the intervention group and control group) engaged in NMUPO via mixed methods, including pre- and postintervention surveys, social media paradata (eg, time-series reactions to posts) collection, and ecological momentary assessment during the intervention. The control group will not receive an intervention but will complete the pre- and postintervention surveys. The primary outcomes will be feasibility, usability, and acceptability, while the secondary outcomes will be psychosocial and behavioral measures, such as past–3-month NMUPO, intention, psychological distress, self-efficacy, resilience, and coping strategies. Results: The proposed study was funded in May 2024. Social media campaigns have received responses from a total of 379 individuals, with 24 (6.3%) identified as eligible. As of February 10, 2025, we have completed formative interviews with 8 eligible participants. Conclusions: The proposed study will be one of the first efforts to develop and deliver a theory-based peer-led intervention on social media, incorporating empirical findings on the psychosocial mechanism of NMUPO. The findings of the proposed study will provide valuable insights into opioid risk reduction for young adults through an innovative approach. If the tested trial is found to be feasible, the proposed study will contribute to future scaled-up and fully powered psychosocial interventions among young adults and other key populations at risk for NMUPO. Trial Registration: ClincialTrials.gov NCT06469749; https://clinicaltrials.gov/study/NCT06469749 International Registered Report Identifier (IRRID): DERR1-10.2196/65847 %M 40139213 %R 10.2196/65847 %U https://www.researchprotocols.org/2025/1/e65847 %U https://doi.org/10.2196/65847 %U http://www.ncbi.nlm.nih.gov/pubmed/40139213 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e55475 %T Feasibility, Acceptability, and Potential Effects of a Digital Oral Anticancer Agent Intervention: Protocol for a Pilot Randomized Controlled Trial %A Ahmed,Saima %A Maheu,Christine %A Gotlieb,Walter %A Batist,Gerald %A Loiselle,Carmen G %+ Segal Cancer Centre, Centre intégré universitaire de santé et de services sociaux du Centre-Ouest-de l’Île-de Montréal, 680 Sherbrooke Street West, Office: 1812, Montreal, QC, H3A 2M7, Canada, 1 514 340 8222 ext 23940, Carmen.loiselle1@mcgill.ca %K oral anticancer agent %K supportive intervention %K medication adherence %K cancer %K oncology %K feasibility %K acceptability %K digital health %K anticancer %K adherence %K compliance %K RCT %K randomized controlled trial %K drug %K pharmacy %K pharmacology %K pharmacotherapy %K pharmaceutic %K pharmaceutical %K medication %K mobile phone %D 2025 %7 26.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Individuals taking oral anticancer agents (OAAs) often face important challenges, requiring more timely informational support, ongoing monitoring, and side effect management. Objective: This study, guided by the Self-Efficacy Theory, aims to assess the feasibility, acceptability, and potential effects of a comprehensive, digital OAA intervention. Methods: A 2-arm, mixed methods, pilot randomized controlled trial took place at a large university-affiliated cancer center in Montreal, Quebec, Canada. Participants (N=52) completed baseline self-report e-questionnaires and subsequently were randomly assigned to the experimental group (intervention plus usual care, n=26) or control group (usual care only, n=26). The study intervention, designed to increase medication adherence via medication adherence self-efficacy and decreased symptom distress, included (1) OAA informational videos, (2) OAA-related e-handouts and other supportive resources, (3) nurse-led follow-up calls, and (4) e-reminders to take OAAs. The e-questionnaires were completed once a week for the first month and every 2 weeks for the subsequent 4 months, or until OAA treatment was completed. A subset from both groups (n=20) participated in semistructured interviews once they completed the study requirements. Study feasibility is assessed using recruitment, retention, and response rates, as well as intervention uptake. Through e-questionnaires and exit interviews, intervention acceptability is to be assessed prospectively at baseline and retrospectively upon study completion. Potential effects are then assessed via medication adherence self-efficacy, medication adherence self-report, and symptom distress. Results: Data collection was completed by December 2023 with a final sample size of 41. Results are expected to be published in 2025. Conclusions: This study relies on a theoretically based, OAA digital intervention with modalities tailored to the needs and preferences of participants. The use of quantitative and qualitative methods enriches our understanding of the potential contributions of the intervention. In addition, following participants over the course of treatment captures potential changes in oral treatment–related processes and outcomes. Trial Registration: ClinicalTrials.gov NCT04984850; https://www.clinicaltrials.gov/study/nct04984850 International Registered Report Identifier (IRRID): DERR1-10.2196/55475 %M 40138678 %R 10.2196/55475 %U https://www.researchprotocols.org/2025/1/e55475 %U https://doi.org/10.2196/55475 %U http://www.ncbi.nlm.nih.gov/pubmed/40138678 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e58393 %T Effect of Clinic-Based and Asynchronous Video-Based Exercise on Clinic and Psychosocial Outcomes in Patients With Knee Osteoarthritis: Quasi-Experimental Study %A Mbada,Chidozie E %A Awosika,Henry Akintunji %A Sonuga,Oluwatobi Ademola %A Akande,Micheal %A Gebrye,Tadesse %A Woolf,Richard %A Fatoye,Francis %+ Department of Health Professions, Faculty of Health and Education, Manchester Metropolitan University, 53 Bonsall Street, Manchester, M15 6GX, United Kingdom, 44 161 247 2963, c.mbada@mmu.ac.uk %K knee osteoarthritis %K video %K physiotherapy %K exercise %K mobile phone %K telehealth %K telemedicine %K randomized %K controlled trial %K asynchronous %K rehabilitation %K knees %K joints %K osteoarthritis %K musculoskeletal %K rheumatology %K physical therapy %D 2025 %7 26.3.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Telerehabilitation is promising for improving knee osteoarthritis, but the effect of different telerehabilitation strategies on knee osteoarthritis is unclear. Objective: This study aimed to examine the effect of a clinic-based strengthening exercise (CbSE) and asynchronous video-based strengthening exercise (AVbSE) on pain, range of motion, muscle strength, quality of life, and physical function among patients with knee osteoarthritis. Methods: A total of 52 consenting patients participated in this 8-week experimental study; they were assigned to the CbSE or AVbSE group at 2 different study sites. CbSE is a circuit exercise module comprising knee flexion and extension warm-up in sitting, quadriceps isometric setting, quadriceps strengthening exercise, hamstring clenches, wall squat, and a cooldown of knee flexion and extension. The AVbSE is an asynchronous video-based version of the CbSE. Results: This study spanned from March 31, 2021, to November 26, 2021. Eight out of 62 participants discontinued participation. Data collection and analysis have been completed. Significant differences were only observed in the mental health (t50=–3, P=.004), pain (t39.4=–3.6, P<.001), social support (t50=–2.7, P=.009), and social activities (t50=2.2, P=.03) domains of the Osteoarthritis Knee and Hip Quality of Life (OAKHQoL) questionnaire with higher scores in the AVbSE group at the end of week 4. At the end of week 8, significant differences were observed in mental health (t50=–2.1, P=.04) and pain (t37.3=–2.8, P=.008) measures with higher scores in AVbSE; however, a significantly higher score was observed in the CbSE group for the Quadruple Visual Analog Scale. No significant main effect of time was observed in this study, except in the muscle strength (F2100=1.5, P=.24), social support (F2100=2.5, P=.09), and social activity (F2100=0.7, P=.48) domains of the OAKHQoL questionnaire and activity limitation (F2100=0.1, P=.90), and performance restriction (F2100=1.3, P=.27) domains of the Ibadan Knee and Hip Osteoarthritis Outcome Measure (IKHOAM) questionnaire. There was no significant difference between groups in all OAKHQoL domains except social activities (mean 17.6, SD 1.2 vs 22.8, SD 1.2; P=.003) and average pain (2.8, SD 1.6 vs 2.3, SD 1.6; P=.03) with higher AVbSE mean scores. However, a higher score was observed for the CbSE group in the Quadruple Visual Analog Scale’s least pain domain (1.2, SD 0.2 vs 0.7, SD 0.2; P=.04). Also, interaction effects showed that AVbSE scores were significantly higher for the OAKHQoL questionnaire’s physical activity and mental health domains at all time points. However, the CbSE score was higher for the physical performance domain of the IKHOAM questionnaire in the eighth week. Conclusions: CbSE circuit training and its AVbSE variant effectively improve treatment outcomes and increase the quality of life of patients. While AVbSE was associated with higher improvement in most health-related quality of life domains, CbSE led to higher improvement in average pain. Trial Registration: Pan African Clinical Trial Registry PACTR202208515182119, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=23943 %M 40138680 %R 10.2196/58393 %U https://www.jmir.org/2025/1/e58393 %U https://doi.org/10.2196/58393 %U http://www.ncbi.nlm.nih.gov/pubmed/40138680 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e67246 %T Efficacy of eHealth Interventions for Hemodialysis Patients: Systematic Review and Meta-Analysis %A Zhou,Xu-Hua %A Chen,Hui %A Yang,Weiwei %A Wang,Li %A Chen,Lin %A Zhu,Ying %A Zhang,Yingjun %A Shi,Mei %A Zhang,Qin %+ Hemodialysis Center, Department of Nephrology, West China Hospital, Sichuan University, 37 Guo-xue-xiang Lane, Wuhou district, Chengdu, Sichuan, PR China, Chengdu, 610041, China, 86 18980601205, clhxxuetou@163.com %K hemodialysis %K eHealth interventions %K quality of life %K treatment adherence %K anxiety %K depression %K meta-analysis %K kidney %K systematic review %K kidney diseases %K kidney function %K chronic diseases %D 2025 %7 26.3.2025 %9 Review %J J Med Internet Res %G English %X Background: Within hemodialysis patient populations, eHealth interventions have been considered as an alternative and complementary option to routine care services. However, the efficacy of eHealth interventions for hemodialysis patients remains poorly understood owing to a lack of rigorous quantitative evidence synthesis. Objective: This meta-analysis aimed to evaluate the efficacy of eHealth interventions in improving quality of life, treatment adherence, and psychological outcomes (anxiety and depression) among hemodialysis patients. In addition, the study sought to identify specific intervention components and methodological quality associated with enhanced quality of life and health outcomes in this population. Methods: A comprehensive search was performed across PubMed, Web of Science, Embase, CINAHL, Cochrane Library, PsycINFO, China National Knowledge Infrastructure, WanFang, China Science and Technology Journal Database, and China BioMedical Literature Database databases from their inception to September 7, 2024. Randomized controlled trials on eHealth interventions for hemodialysis patients published in English or Chinese were included. Critical appraisal was carried out independently by 2 reviewers to assess the bias risk of the studies included. Quantitative synthesis of the outcomes of interest was conducted using a random-effects model. The quality of evidence for the outcomes was evaluated following the Grading of Recommendations, Assessment, Development, and Evaluation approach. Results: A total of 17 randomized controlled trials involving 1728 participants were included in this meta-analysis out of 5741 articles identified in the initial database search and additional search references. In the 17 studies, 8 kinds of eHealth intervention delivery formats were used, including text messages, telephone sessions, video, network platforms, social media, computers, websites, and mobile apps. The majority of research studies used a single form of eHealth intervention, and 7 studies adopted a combined approach of 2 or more eHealth technologies. The duration of eHealth interventions demonstrated substantial variability across studies, spanning from 4 weeks to 12 months, of which 3 months was the most common. A total of 14 (82%) studies were considered to have “some concern” about selection bias. In addition, 15 (88%) trials were classified as having a “high risk” of performance and detection bias, and all trials were judged to be at “low risk” of attrition and reporting bias. The pooled results revealed a significant difference between the eHealth interventions and control groups on quality of life (standardized mean difference [SMD]=0.87, 95 % CI 0.38 to 1.37, low certainty evidence), treatment adherence (SMD=1.11, 95 % CI 0.30 to 1.91, moderate certainty evidence), anxiety (SMD=–2.11, 95 % CI –3.25 to –0.97, moderate certainty evidence), and depression (SMD=–2.46, 95 % CI –3.68 to –1.25, moderate certainty evidence). Conclusions: eHealth interventions could be a beneficial approach for improving quality of life and treatment adherence and reducing anxiety and depression among hemodialysis patients. However, future high-quality randomized controlled trials are essential to draw more reliable conclusions. Trial Registration: PROSPERO CRD42024589799; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024589799 %R 10.2196/67246 %U https://www.jmir.org/2025/1/e67246 %U https://doi.org/10.2196/67246 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e52121 %T Tailoring a Skills-Based Serostatus Disclosure Intervention for Transgender Women in South Africa: Protocol for a Usability and Feasibility Study %A Daniels,Joseph %A van der Merwe,Leonashia Leigh-Ann %A Portle,Sarah %A Bongo,Cikizwa %A Nadkarni,Shiv %A Petrus Peters,Remco %+ Edson College of Nursing and Health Innovation, Arizona State University, 500 N 3rd Street, Phoenix, AZ, 85004, United States, daniels.joseph@gmail.com %K transgender women %K intervention development %K relationships %K HIV treatment %K South Africa %K mobile phones, smartphones %K skills-based %K serostatus disclosure %K HIV %K HIV prevention %K transgender %K treatment outcomes %K transmission %K HIV-discordant partnerships %K behavioral intervention %K safe sex %K human-centered design %K viral suppression %K Speaking Out and Allying Relationships %K LGBTQ2S %K LGBTQ %K 2SILGBTQ %D 2025 %7 26.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Transgender women have few interventions to support their HIV prevention and treatment outcomes in South Africa. Further, increased focus should be on intervention development that will reduce HIV transmission within HIV-discordant partnerships, especially for transgender women who navigate gender, sexuality, and relationship stigma. The Speaking Out and Allying Relationships (SOAR) intervention has been developed for sexual minority men to address these outcomes in South Africa. It is a behavioral intervention that is delivered in groups via videoconference to develop coping skills to manage HIV-related stress, assist with disclosure to partners, and establish and maintain safer sex practices with partners. Tailoring SOAR may be feasible for transgender women to support their HIV care while reducing transmission within their relationships. Objective: This study aims to (1) adapt SOAR for transgender women and test its usability, then (2) assess its feasibility. Methods: To achieve aim 1, we will use a human-centered design approach to tailor the existing SOAR intervention for transgender women. Interviews and a survey will be administered to transgender women (N=15) to assess intervention preferences. Findings will be used to tailor content like roleplays, scenarios, and media to align with transgender women’s lived experiences navigating HIV and relationships. Afterward, we will conduct a usability test with 7 (47%) of the 15 participants to determine intervention understanding and satisfaction. Participants will be transgender women living with HIV and in a relationship with a man who has unknown HIV status or is HIV-negative. All participants will be recruited using community-based approaches. In aim 2, we will examine SOAR feasibility using a 1-arm pilot study. Transgender women (N=20) will be recruited using aim 1 methods and eligibility criteria, with participants completing feasibility surveys and interviews, as well as behavioral and biomedical assessments. Results: Intervention adaptation began in May 2023 with interviews. Feasibility pilot testing was conducted with 14 transgender women, with study completion in January 2025. Conclusions: Transgender women need more intervention options that engage their relationships since these can present barriers to HIV treatment outcomes like hindering viral suppression in South Africa. Delivering an existing yet tailored intervention via videoconference expands its reach to transgender women and allows them to engage with others and learn new skills in a secure setting like their homes. SOAR has the potential to improve relationship dynamics and reduce violence, which will in turn enhance HIV treatment and prevention engagement. International Registered Report Identifier (IRRID): PRR1-10.2196/52121 %M 40138676 %R 10.2196/52121 %U https://www.researchprotocols.org/2025/1/e52121 %U https://doi.org/10.2196/52121 %U http://www.ncbi.nlm.nih.gov/pubmed/40138676 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e69828 %T Evaluating a Digital Health Tool Designed to Improve Low Sexual Desire in Women: Mixed-Methods Implementation Science Study %A Brotto,Lori A %A Stephenson,Kyle R %A Marshall,Nisha %A Balvan,Mariia %A Okara,Yaroslava %A Mahar,Elizabeth A %+ Department of Obstetrics and Gynaecology, University of British Columbia, 2775 Laurel Street, Department of Gynaecology, Vancouver, BC, V5Z1M9, Canada, 1 6048754111 ext 68898, lori.brotto@ubc.ca %K implementation science %K sexual interest/arousal disorder (SIAD) %K sexuality %K internet interventions %K online therapy %K telehealth %K online interventions %K web-based therapeutic programs/interventions %K online CBT/MBT treatment %K female sexual dysfunction %K eHealth %D 2025 %7 25.3.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Sexual health difficulties affect up to 30% of women, with desire and arousal problems being the most prevalent. While cognitive behavioral therapy and mindfulness-based therapy are effective treatments, access is limited by barriers such as specialist shortages, cost, and embarrassment. Web-based interventions offer a potential solution by providing self-paced, cost-effective treatments. eSense, a digital health program, offers cognitive behavioral therapy and mindfulness-based therapy skills targeted to women with low sexual desire, and previous trials find eSense to be highly feasible and efficacious. Objective: The goal of the present implementation science study was to use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance of Implementation) framework to assess the integration of eSense into several sexual health clinics. We chose the RE-AIM framework because it addresses both dissemination (eg, reach) and implementation of an intervention. Methods: A total of 14 specialty clinics participated, and we report on the reported experiences of those clinics in implementing eSense. We also examined responses from 12 women on waitlists to receive sex therapy or sexual medicine care. Results: Per clinic outcomes, all aspects of implementation (reach, effectiveness, adoption, implementation, and maintenance) were in the moderate to high range for clinics, reporting that offering eSense helped them overcome negative feelings associated with their long clinic waitlists. The majority expressed a need for eSense and could see how it overcame the limitations of traditional therapy. Nearly all expressed a wish to continue offering eSense to patients after the implementation study was complete. One caveat was that half of the clinics noted cost as a key issue for future implementation, and one-third noted that the administrative burden of implementing eSense as a standard of care may be challenging. For individual users, the majority expressed an interest in knowing more about eSense and a desire to use eSense, though most of these did not complete the program in its entirety. Users experienced a significant improvement in sex-related distress with no clinically meaningful change in other outcomes and a high level of satisfaction with eSense. Most also reported doing things differently in their sexual lives after participating in eSense. Conclusions: We found that eSense demonstrates potential as a digital intervention for sexual difficulties for women, particularly concerning its moderate implementation outcomes and also because of its ability to reduce sexual distress. Future studies should address the barriers identified for broader adoption of eSense in clinical settings. Trial Registration: ClinicalTrials.gov NCT05168371; https://clinicaltrials.gov/study/NCT05168371 %M 40132194 %R 10.2196/69828 %U https://www.jmir.org/2025/1/e69828 %U https://doi.org/10.2196/69828 %U http://www.ncbi.nlm.nih.gov/pubmed/40132194 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 12 %N %P e68165 %T Effectiveness of General Practitioner Referral Versus Self-Referral Pathways to Guided Internet-Delivered Cognitive Behavioral Therapy for Depression, Panic Disorder, and Social Anxiety Disorder: Naturalistic Study %A Bjarke,Jill %A Gjestad,Rolf %A Nordgreen,Tine %K referral pathway %K GP-referral %K self-referral %K guided internet-delivered cognitive behavioral therapy %K ICBT %K routine care clinic %K depression %K panic disorder %K social anxiety disorder %K psychological therapy %K referrals %K cognitive %K behavioral therapy %K anxiety %K SAD %K treatment effectiveness %K mental health %K pathways %D 2025 %7 25.3.2025 %9 %J JMIR Ment Health %G English %X Background: Therapist-guided, internet-delivered cognitive behavioral therapy (guided ICBT) appears to be efficacious for depression, panic disorder (PD), and social anxiety disorder (SAD) in routine care clinical settings. However, implementation of guided ICBT in specialist mental health services is limited partly due to low referral rates from general practitioners (GP), which may stem from lack of awareness, limited knowledge of its effectiveness, or negative attitudes toward the treatment format. In response, self-referral systems were introduced in mental health care about a decade ago to improve access to care, yet little is known about how referral pathways may affect treatment outcomes in guided ICBT. Objective: This study aims to compare the overall treatment effectiveness of GP referral and self-referral to guided ICBT for patients with depression, PD, or SAD in a specialized routine care clinic. This study also explores if the treatment effectiveness varies between referral pathways and the respective diagnoses. Methods: This naturalistic open effectiveness study compares treatment outcomes from pretreatment to posttreatment and from pretreatment to 6-month follow-up across 2 referral pathways. All patients underwent module-based guided ICBT lasting up to 14 weeks. The modules covered psychoeducation, working with negative or automatic thoughts, exposure training, and relapse prevention. Patients received weekly therapist guidance through asynchronous messaging, with therapists spending an average of 10‐30 minutes per patient per week. Patients self-reported symptoms before, during, immediately after, and 6 months posttreatment. Level and change in symptom severity were measured across all diagnoses. Results: In total, 460 patients met the inclusion criteria, of which 305 were GP-referred (“GP” group) and 155 were self-referred (“self” group). Across the total sample, about 60% were female, and patients had a mean age of 32 years and average duration of disorder of 10 years. We found no significant differences in pretreatment symptom levels between referral pathways and across the diagnoses. Estimated effect sizes based on linear mixed modeling showed large improvements from pretreatment to posttreatment and from pretreatment to follow-up across all diagnoses, with statistically significant differences between referral pathways (GP: 0.97‐1.22 vs self: 1.34‐1.58, P<.001-.002) and for the diagnoses separately: depression (GP: 0.86‐1.26, self: 1.97‐2.07, P<.001-.02), PD (GP: 1.32‐1.60 vs self: 1.64‐2.08, P=.06-.02) and SAD (GP: 0.80‐0.99 vs self: 0.99‐1.19, P=.18-.22). Conclusions: Self-referral to guided ICBT for depression and PD appears to yield greater treatment outcomes compared to GP referrals. We found no difference in outcome between referral pathway for SAD. This study underscores the potential of self-referral pathways to enhance access to evidence-based psychological treatment, improve treatment outcomes, and promote sustained engagement in specialist mental health services. Future studies should examine the effect of the self-referral pathway when it is implemented on a larger scale. %R 10.2196/68165 %U https://mental.jmir.org/2025/1/e68165 %U https://doi.org/10.2196/68165 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e66393 %T Exploring the Discontinuous Usage Behavior of Digital Cognitive Training Among Older Adults With Mild Cognitive Impairment and Their Family Members: Qualitative Study Using the Extended Model of IT Continuance %A Zhang,Shangyang %A Wu,Min %A Sun,Ruini %A Cui,Changjie %A Zhang,Ziqing %A Liao,Jing %A Gong,Ni %+ School of Nursing, Jinan University, No. 601, Huangpu Avenue West, Tianhe District, Guangzhou, 510632, China, 1 15013217344, gongni_1025@163.com %K digital cognitive training %K discontinuous usage behavior %K acceptance %K mild cognitive impairment %K qualitative study %D 2025 %7 25.3.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital cognitive training (DCT) has been found to be more effective than traditional paper-and-pencil training in enhancing overall cognitive function. However, a significant barrier to its long-term implementation is that older adults with mild cognitive impairment (MCI) do not continue to use it or even show a dropoff in usage after the initial engagement. Such short-term engagement may limit the potential benefits of DCT, as sustained use is required to achieve more pronounced cognitive improvements. Exploring the reasons for the shift in discontinuous usage behavior is crucial for promoting successful DCT implementation and maximizing its positive effects. Objective: This study aimed to explore the intrinsic reasons for the transition from initial acceptance to discontinuous usage behavior among older adults with MCI throughout the DCT process, by employing the extended model of IT continuance (ECM-ITC). Methods: We employed a qualitative research methodology and conducted 38 semistructured interviews before and after the use of DCT (3 times per week over 1 month, with each session lasting 30 minutes) with 19 older adults with MCI (aged 60 years or older) and 4 family members between January and March 2024. Thematic analysis and deductive framework analysis were used to identify the reasons for the discontinuous usage of DCT, with mapping to the ECM-ITC. Results: Most participants failed to complete the standard dosage of DCT. Data analysis revealed the reasons for the shift to discontinuous usage. Despite their need to improve cognitive function, participants found the cognitive training confusing and discovered that DCT did not align with their preferred method of training upon actual use. The disparity between their vague expectations and reality, combined with the contradiction between the “delayed gratification” of DCT and their desire for “immediate gratification,” made it difficult for them to discern the usefulness of DCT. Participants also viewed DCT as an additional financial burden and tended to avoid training under family pressure. They relied on motivational measures, which further weakened their intention to continue DCT, ultimately leading to the inability to develop continuous usage behavior. Conclusions: Continuous usage behavior differs from initial acceptance as it evolves dynamically with user experience over time. To encourage older adults with MCI to persistently engage with DCT, it is essential to not only thoroughly consider their genuine preferences and the potential disruptions DCT may bring to their lives but also bridge the gap between expectations and actual experiences. While ensuring that older adults receive appropriate external incentives and encouragement, it is equally important to foster their intrinsic motivation, thereby gradually cultivating the habit of sustained DCT usage. %M 40132189 %R 10.2196/66393 %U https://www.jmir.org/2025/1/e66393 %U https://doi.org/10.2196/66393 %U http://www.ncbi.nlm.nih.gov/pubmed/40132189 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e67219 %T Examining the Efficacy of the Telehealth Assessment and Skill-Building Kit (TASK III) Intervention for Stroke Caregivers: Protocol for a Randomized Controlled Clinical Trial %A Bakas,Tamilyn %A Miller,Elaine %A Sucharew,Heidi %A Kreitzer,Natalie %A Israel,Jahmeel %A Rota,Matthew %A Harnett,Brett %A Dunning,Kari %A Jones,Holly %A McCarthy,Michael %A Brehm,Bonnie %A Austin,Joan K %A Mitchell,Pamela H %+ Department of Population Health, College of Nursing, University of Cincinnati, 3110 Vine Street, PO Box 210038, Cincinnati, OH, 45221, United States, 1 513 558 2254, bakastn@ucmail.uc.edu %K stroke %K family caregivers %K depressive symptoms %K health-related quality of life %K clinical trial %K intervention study %K protocol %K nursing %D 2025 %7 25.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Stroke is a leading cause of serious, long-term disability and has a sudden onset. Upon discharge to the home setting, families are thrust into providing care, often without sufficient training from health care providers. Aligned with current patient and caregiver guidelines, the Telehealth Assessment and Skill-Building Kit (TASK III) is a nurse-led intervention designed to empower caregivers to address their own needs and those of the survivor using innovative skill-building strategies. Objective: This study aims to test the short-term (immediately after the intervention at 8 wk) and long-term (12, 24, and 52 wk) efficacy of the TASK III intervention, compared with an information, support, and referral (ISR) group, to improve caregiver life changes (ie, changes in physical health, physical functioning, emotional well-being, and general health) as a result of providing care. Methods: A randomized controlled clinical trial design will be used with baseline data collection from 296 family caregivers by telephone after the stroke survivor is discharged home. Caregivers randomly assigned to the ISR group (n=148, 50%) will receive information from the American Heart Association about stroke family caregiving. Caregivers randomly assigned to the TASK III group (n=148, 50%) will receive a TASK III resource guide and information from the American Heart Association. Both groups will receive 8 weekly calls from a nurse, with a booster call a month later. Outcomes will be assessed by blinded data collectors at 8, 12, 24, and 52 weeks. The primary outcome (at 8 wk) is caregiver life changes measured by the Bakas Caregiving Outcomes Scale. Secondary outcomes are depressive symptoms; other symptoms (eg, stress, fatigue, sleep, pain, and shortness of breath); unhealthy days; diet; exercise; and self-reported health care use. Mediators are task difficulty, threat appraisal, and self-efficacy. Program evaluation outcomes (satisfaction and technology ratings) will also be analyzed. Results: The trial was registered on March 10, 2022. Enrollment and random assignment of the first participant was on November 30, 2022, with an anticipated completion of recruitment by November 30, 2025. Completion of the primary end point data analysis is anticipated by August 31, 2026, with results expected to be reported on ClinicalTrials.gov by April 1, 2027. As of October 9, 2024, a total of 198 (66.9% of the proposed total sample of 296) family caregivers have been enrolled and randomly assigned to the TASK III group (n=98, 49.5%) or the ISR group (n=100, 50.5%). The last update was performed on January 25, 2024. Conclusions: If the TASK III intervention is shown to be efficacious in the proposed randomized controlled clinical trial, our next goal will be to translate TASK III into ongoing stroke systems of care, providing a tremendous public health impact. Trial Registration: ClinicalTrials.gov NCT05304078; https://clinicaltrials.gov/study/NCT05304078 International Registered Report Identifier (IRRID): DERR1-10.2196/67219 %M 39937971 %R 10.2196/67219 %U https://www.researchprotocols.org/2025/1/e67219 %U https://doi.org/10.2196/67219 %U http://www.ncbi.nlm.nih.gov/pubmed/39937971 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 13 %N %P e56296 %T Application of Behavior Change Techniques and Rated Quality of Smoking Cessation Apps in China: Content Analysis %A Hong,Qiumian %A Wei,Shuochi %A Duoliken,Hazizi %A Jin,Lefan %A Zhang,Ning %K smoking cessation %K behavior change techniques %K mobile application %K content analysis %K China %D 2025 %7 24.3.2025 %9 %J JMIR Mhealth Uhealth %G English %X Background: Smoking cessation apps are increasingly being used to help smokers quit smoking. In China, whether behavioral science–based techniques are being incorporated into smoking cessation apps remains unknown. Objectives: This study aims to describe the usage of behavior change techniques (BCTs) among smoking cessation apps available in China and to evaluate the relationship between BCT utilization and the quality of available smoking cessation apps. Methods: We searched eligible smoking cessation apps twice on September 12 and October 4, 2022. We coded them with BCTs and assessed their quality by the Mobile App Rating Scale (MARS) and rating score in the App Store. We described the quality of each app (ie, engagement, function, esthetic, and information) and the BCTs used within it, as well as the amount and proportion of all BCTs used. Correlation analysis and linear regression analysis were used to assess the association between the number of BCTs used and the quality of apps. Results: Nine apps were included in the final analyses. The average number of BCTs being used was 11.44 (SD 2.57), ranging from 5 to 29. Only 1 app used more than 20 BCTs. The most frequently used BCTs were providing feedback on current smoking behavior (9/9, 100%), prompting review of goals (8/9, 88.89%), prompting self-monitoring of one’s smoking behavior (7/9, 77.78%), and assessing current and past smoking behavior (7/9, 77.78%). The most commonly used BCTS specifically focus on behavior, including BM (B refers to behavior change, M focuses on addressing motivation; 4.44/11, 40.36%) and BS (B refers to behavior change, S refers to maximizing self-regulatory capacity or skills; 3.78/11, 34.36%). The average score of MARS for the apps was 3.88 (SD 0.38), ranging from 3.29 to 4.46, which was positively correlated with the number of BCTs used (r=0.79; P=.01). Specifically, more usage of BCTs was associated with higher engagement score (β=.74; P=.02; R2=0.52) and higher information score (β=.76; P=.02; R2=0.52). Conclusions: The quality of smoking cessation apps assessed by MARS was correlated with the number of BCTs used. However, overall, the usage of BCTs was insufficient and imbalanced, and the apps demonstrated low quality of engagement and information dimensions. Coordinated efforts from policy makers, technology companies, health behavior professionals, and health care providers should be made to reduce tobacco consumption and to develop high-quality, widely accessible, and effective smoking cessation apps to help smokers quit smoking. %R 10.2196/56296 %U https://mhealth.jmir.org/2025/1/e56296 %U https://doi.org/10.2196/56296 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e57537 %T Acceptability and Effectiveness of a Fully Web-Based Nutrition and Exercise Program for Individuals With Chronic Disease During COVID-19: Randomized Controlled Trial %A Tandon,Puneeta %A Ismond,Kathleen P %A Purdy,Graeme %A Cruz,Christofer %A Etruw,Evelyn %A Suderman,Kirsten %A Hyde,Ashley %A Stickland,Michael %A Spence,John C %A Lien,Dale C %A Bhanji,Rahima %A Prado,Carla M %A Miguel-Cruz,Antonio %A Joy,Anil A %A Yaskina,Maryna %A McNeely,Margaret L %+ Department of Medicine, Faculty of Medicine & Dentistry, University of Alberta, 8540 112 Street, Edmonton, AB, T6G2X8, Canada, 1 7804929844, ptandon@ualberta.ca %K eHealth %K patient-centered care %K adults %K geriatrics %K self-management %K web-based %K nutrition %K exercise rehabilitation %K wearable %K activity tracker %K quality of life %K physical health %K 2-minute step test %K patients with cancer %K chronic diseases %K COVID-19 %K randomized controlled trial %K acceptability %K effectiveness %K intervention %D 2025 %7 24.3.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: In-person nutrition and exercise interventions improve physical function in chronic diseases, yet the acceptability and effectiveness of web-based delivery, especially with different levels of personnel support, require further investigation. Objective: This study aims to evaluate a web-based nutrition and exercise intervention delivered entirely digitally from recruitment to trial completion. Methods: A randomized controlled trial was conducted using the Heal-Me version 1 platform across 2 levels of personnel support (Light and Intensive). Eligible adults with a history of cancer, chronic lung disease, or liver or lung transplant; internet access; and prior participation in a rehabilitation program were enrolled in a fully web-based program to minimize barriers to exercise participation. Participants were randomly assigned (1:1:1) to 1 of 3 study groups. The control group received a detailed, self-directed digital nutrition and exercise guide. The Heal-Me Light group received the web-based intervention alongside dietitian and exercise specialist–led group classes. The Heal-Me Intensive group received web-based intervention, group classes, and one-to-one sessions with the dietitians and exercise specialists. All participants received a wearable activity tracker. The primary acceptability outcome was adherence to the intervention based on a priori targets. The primary effectiveness outcome was the change in Lower Extremity Functional Scale (LEFS) score. Secondary outcomes included physical function tests, which were performed and measured by videoconference. Questionnaires were used to assess well-being, quality of life, and food intake. Analyses adhered to the intention-to-treat principle. Results: Of 216 participants, 202 (93.5%) completed the intervention (mean 61, SD 11 years; female: 130/202, 64.4%; cancer: 126/202, 62.4%). Adherence exceeded a priori targets, with 82% (105/128) attending >75% of the program elements including postintervention tests. Participants rated the program as “quite a bit” or “very” useful, with similar ratings between Heal-Me Light (56/64, 88%) and Heal-Me Intensive (51/58, 88%) groups (P=.69). No significant differences were found for changes in LEFS scores (control: mean 0.8, SD 7.7; Heal-Me: mean 0.3, SD 6.6; P=.53). Significant benefits were found in favor of the combined Heal-Me intervention groups versus controls for change in the 2-minute step test, World Health Organization-5 Well-Being Index, Short-Form-36 general, physical health role, energy or fatigue scales, and protein intake. While the change in physical function was similar between the 2 intervention arms, the more intensive one-to-one interaction (Heal-Me Intensive) led to greater improvements in perceived nutrition self-management. No serious adverse events occurred. Conclusions: The demonstrated satisfaction, adherence, and effectiveness highlight the high acceptability of a web-based, semisupervised nutrition and exercise intervention delivered entirely digitally in individuals with chronic disease. Future studies may benefit from having a baseline physical function inclusion threshold, the use of a more sensitive primary physical function measure, and a higher intensity digital exercise intervention in exercise-experienced participants. Trial Registration: Clinicaltrials.gov NCT04666558; https://clinicaltrials.gov/study/NCT04666558 International Registered Report Identifier (IRRID): RR2-10.1016/j.cct.2022.106791 %M 40126542 %R 10.2196/57537 %U https://www.jmir.org/2025/1/e57537 %U https://doi.org/10.2196/57537 %U http://www.ncbi.nlm.nih.gov/pubmed/40126542 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 8 %N %P e65826 %T Digital Interventions for Patients With Juvenile Idiopathic Arthritis: Systematic Review and Meta-Analysis %A Ren,Zihan %A Chen,Yawen %A Li,Yufeng %A Fan,Panyu %A Liu,Zhao %A Shen,Biyu %K juvenile idiopathic arthritis %K digital intervention %K application %K children health care %K pediatrics %D 2025 %7 21.3.2025 %9 %J JMIR Pediatr Parent %G English %X Background: Juvenile idiopathic arthritis (JIA) is a chronic rheumatic condition requiring long-term, multidisciplinary treatment, which consumes significant health care resources and family energy. This study aims to analyze the effectiveness of digital interventions on patient outcomes in individuals with JIA. Objective: This meta-analysis aimed to evaluate the impact of digital interventions on alleviating symptoms and improving overall well-being in children and adolescents with JIA. Methods: A systematic search of 5 databases identified randomized controlled trials assessing the impact of digital interventions on physiological and psychological outcomes in adolescents and children (average age ≤19 y). Outcomes included pain, physical activity, health-related quality of life, self-efficacy, and disease-related issues. A total of 2 reviewers independently screened papers and extracted data on intervention functionalities and outcomes, assessing the risk of bias. A meta-analysis using a random-effects model synthesized the results. Results: The review included 11 studies involving 885 patients with JIA. Digital interventions included educational (eg, self-management training), therapeutic (eg, pain management), and behavioral (eg, promoting physical activity) approaches. These were delivered through websites, telephone consultations, video conferences, apps, and interactive games, with durations ranging from 8 to 24 weeks and no clear link observed between intervention length and outcomes. Compared with conventional control groups, digital interventions were significantly effective in alleviating pain (standardized mean difference [SMD] −0.19, 95% CI −0.35 to −0.04) and enhancing physical activity levels (SMD 0.37, 95% CI 0.06-0.69). Marginal improvements in health-related quality of life, self-efficacy, and disease-related issues were observed, but these did not reach statistical significance (SMD −0.04, 95% CI −0.19 to 0.11; SMD 0.05, 95% CI −0.11 to 0.20; and SMD 0.09, 95% CI −0.11 to 0.29, respectively). The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach rated the quality of evidence for pain, health-related quality of life, self-efficacy, and disease-related issues as moderate, while the evidence quality for physical activity was assessed as low. Conclusions: Digital interventions can alleviate pain and enhance physical activity in patients with JIA. However, given the limited sample size and high risk of bias in some studies, further high-quality research is needed to improve the treatment and management of JIA. Trial Registration: PROSPERO CRD42023471223; https://www.crd.york.ac.uk/PROSPERO/view/CRD42023471223 %R 10.2196/65826 %U https://pediatrics.jmir.org/2025/1/e65826 %U https://doi.org/10.2196/65826 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e68085 %T Multilevel Intervention to Support Tailored and Responsive HIV Pre-Exposure Prophylaxis Care in Rural North Carolina: Protocol for a Randomized Controlled Trial %A Rutstein,Sarah E %A Ferguson,Ella %A Mansour,Odai %A Brown,Nicole %A Stocks,Jacob B %A Washington,Anja %A Mobley,Victoria %A Dowler,Shannon %A Edwards,Jessie %A Hightow-Weidman,Lisa B %A Hurt,Christopher B %A Pence,Brian %A Muessig,Kathryn E %+ Department of Medicine, University of North Carolina at Chapel Hill, 130 Mason Farm Rd, Chapel Hill, NC, 27514, United States, 1 919 843 5859, srutstein@unc.edu %K pre-exposure prophylaxis navigation %K PrEP navigation %K digital health app %K mobile health %K mHealth %K telehealth %K public health %K sexually transmitted infection %K HIV prevention %K mobile phone %D 2025 %7 21.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: While access to pre-exposure prophylaxis (PrEP) is an important tool for reducing HIV incidence in the United States, disparities in uptake by race, sex, socioeconomic status, and geography persist. In 2018, the US South accounted for more than half of all new HIV diagnoses but only one-third of PrEP users. PrEP use in North Carolina (NC) similarly lags, with uptake being the lowest among young, sexual and gender minority populations, who account for nearly two-thirds of the state’s incident infections. The PrEP-to-need ratio, a metric of PrEP equity that measures PrEP uptake relative to new HIV diagnoses, highlights disparities in PrEP uptake among specific demographic groups such as women and Black, Hispanic, and Southern people, indicating that these groups are underserved relative to their epidemic need. Despite behavioral risk overlap of incident sexually transmitted infections (STIs) and HIV, in NC, PrEP is only offered at a few primarily urban health department–affiliated STI clinics. The lack of robust health care infrastructure in these areas presents challenges for HIV prevention services. Objective: This protocol describes a randomized controlled trial of a multilevel PrEP intervention recruiting from rural and periurban STI clinics. Methods: This trial aims to enroll up to 336 participants and randomly assign them 1:1 to either the intervention or control group. The intervention consists of access to a digital health app, linkage to a remote PrEP navigator, and the option of referral to telehealth-based PrEP services. Persons randomly assigned to the control condition will receive an enhanced standard of care, including access to a limited version of the digital health app. All participants will be followed up on quarterly for at least 3 months. The primary outcome is the initiation of PrEP within 3 months of an index STI clinic visit; secondary outcomes evaluate PrEP care engagement and adherence, incident HIV and bacterial STI infections, PrEP stigma, and cost-effectiveness. Binary outcome analyses will estimate the proportion of participants achieving an event (eg, PrEP uptake) in each arm and a probability difference and the corresponding 95% CI to compare the intervention versus control arm at each time point. Continuous end points will use nonparametric Wilcoxon rank sum tests comparing the intervention and control groups. Results: Enrollment opened on August 31, 2023, at 15 health departments in NC and subsequently expanded to 21 facilities in 20 counties by July 2024. Completion of the enrollment and data collection phases is expected by May 2025. Results will be published thereafter. Conclusions: This study directly addresses multiple barriers to PrEP use in rural and periurban areas of the Southeastern United States and can inform policy and programming that seek to expand PrEP access and promote use in underserved communities. Trial Registration: ClinicalTrials.gov NCT05984030; https://clinicaltrials.gov/study/NCT05984030 International Registered Report Identifier (IRRID): DERR1-10.2196/68085 %M 40117579 %R 10.2196/68085 %U https://www.researchprotocols.org/2025/1/e68085 %U https://doi.org/10.2196/68085 %U http://www.ncbi.nlm.nih.gov/pubmed/40117579 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e60647 %T Exploring Laypersons’ Experiences With a Mobile Symptom Checker App as an Interface Between eHealth Literacy, Health Literacy, and Health-Related Behavior: Qualitative Interview Study %A Koch,Roland %A Steffen,Marie-Theres %A Wetzel,Anna-Jasmin %A Preiser,Christine %A Klemmt,Malte %A Ehni,Hans-Jörg %A Mueller,Regina %A Joos,Stefanie %+ Institute for General Practice and Interprofessional Care, Tübingen University Hospital, Tübingen, Germany, 49 1758065961, roland.koch@med.uni-tuebingen.de %K symptom checker apps %K health literacy %K eHealth literacy %K qualitative research %K interview study %K artificial intelligence %K AI %D 2025 %7 21.3.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Symptom checkers aim to help users recognize medical symptoms and recommend actions. However, they are not yet reliable for self-triage or diagnostics. Health literacy plays a role in their use, but the process from symptom recognition to health care consultation remains unclear. Objective: This qualitative observatory study explored how laypersons use symptom checkers, focusing on the process of use, entry points and outcomes, and the role of health literacy. Laypersons are defined as individuals who are neither medical professionals nor developers of such apps. Three research questions were addressed: (1) How do such users describe the process of using symptom checkers? (2) What are entry points and possible outcomes of symptom checker app use? (3) How are health literacy and eHealth literacy expressed during the use of symptom checker apps? Methods: As part of the Ethical, Legal, and Social Implications of Symptom Checker Apps in Primary Health Care project, 15 laypersons (n=9, 60% female and n=6, 40% male; mean age 30.7, SD 13.6 years) were interviewed about their experiences with the symptom checker Ada. The interviews were analyzed using an integrative approach combining social positioning, agency, and the Rubicon model as a heuristic framework. Results: App use follows a cyclic process comprising 4 steps: motivation (influenced by biography and context), intention formation (assigning a purpose), intention implementation (recruiting resources), and evaluation (transforming interactions into health-related insights). Biographical, social, and contextual factors shape process initiation. Users use symptom checkers for 3 main purposes: understanding their condition, receiving recommendations for action, and documenting or communicating health-related information. Each purpose requires specific planning and integration into health-related behaviors drawing on personal, social, and technological resources. Evaluation depends on contextual factors, app outputs, and the outcomes of users’ health-related actions. Users assess whether the app aligns with their expectations, condition severity, and previous experiences, with health literacy playing a critical role in validation processes. Conclusions: Symptom checker use is a complex, cyclic process shaped by context, biography, and health literacy. Users are motivated by health concerns influenced by personal, social, and contextual factors, with trust and attitudes impacting initial engagement. Intention formation reflects a balance between user skills and context, where app outputs inform decisions but may not always lead to action, especially in ambiguous situations. Users rely on personal resources and social networks to integrate app use into health-related behaviors, highlighting the limitations of symptom checkers in providing social or empathetic support. Symptom checkers have the potential to serve as an interface between users and health care, but future development must address the complexity of their use to unlock this potential. International Registered Report Identifier (IRRID): RR2-10.2196/34026 %M 40117573 %R 10.2196/60647 %U https://formative.jmir.org/2025/1/e60647 %U https://doi.org/10.2196/60647 %U http://www.ncbi.nlm.nih.gov/pubmed/40117573 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e59209 %T Embedding a Choice Experiment in an Online Decision Aid or Tool: Scoping Review %A Wickramasekera,Nyantara %A Shackley,Phil %A Rowen,Donna %+ , Sheffield Centre for Health and Related Research (SCHARR), The University of Sheffield, 30 Regent St, Sheffield, S14DA, United Kingdom, 44 01142224348, N.Wickramasekera@sheffield.ac.uk %K decision aid %K decision tool %K discrete choice experiment %K conjoint analysis %K value clarification %K scoping review %K choice experiment %K database %K study %K article %K data charting %K narrative synthesis %D 2025 %7 21.3.2025 %9 Review %J J Med Internet Res %G English %X Background: Decision aids empower patients to understand how treatment options match their preferences. Choice experiments, a method to clarify values used within decision aids, present patients with hypothetical scenarios to reveal their preferences for treatment characteristics. Given the rise in research embedding choice experiments in decision tools and the emergence of novel developments in embedding methodology, a scoping review is warranted. Objective: This scoping review examines how choice experiments are embedded into decision tools and how these tools are evaluated, to identify best practices. Methods: This scoping review followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Searches were conducted on MEDLINE, PsycInfo, and Web of Science. The methodology, development and evaluation details of decision aids were extracted and summarized using narrative synthesis. Results: Overall, 33 papers reporting 22 tools were included in the scoping review. These tools were developed for various health conditions, including musculoskeletal (7/22, 32%), oncological (8/22, 36%), and chronic conditions (7/22, 32%). Most decision tools (17/22, 77%) were developed in the United States, with the remaining tools originating in the Netherlands, United Kingdom, Canada, and Australia. The number of publications increased, with 73% (16/22) published since 2015, peaking at 4 publications in 2019. The primary purpose of these tools (20/22, 91%) was to help patients compare or choose treatments. Adaptive conjoint analysis was the most frequently used design type (10/22, 45%), followed by conjoint analysis and discrete choice experiments (DCEs; both 4/22, 18%), modified adaptive conjoint analysis (3/22, 14%), and adaptive best-worst conjoint analysis (1/22, 5%). The number of tasks varied depending on the design (6-12 for DCEs and adaptive conjoint vs 16-20 for conjoint analysis designs). Sawtooth software was commonly used (14/22, 64%) to embed choice tasks. Four proof-of-concept embedding methods were identified: scenario analysis, known preference phenotypes, Bayesian collaborative filtering, and penalized multinomial logit model. After completing the choice tasks patients received tailored information, 73% (16/22) of tools provided attribute importance scores, and 23% (5/22) presented a “best match” treatment ranking. To convey probabilistic attributes, most tools (13/22, 59%) used a combination of approaches, including percentages, natural frequencies, icon arrays, narratives, and videos. The tools were evaluated across diverse study designs (randomized controlled trials, mixed methods, and cohort studies), with sample sizes ranging from 23 to 743 participants. Over 40 different outcomes were included in the evaluations, with the decisional conflict scale being the most frequently used in 6 tools. Conclusions: This scoping review provides an overview of how choice experiments are embedded into decision tools. It highlights the lack of established best practices for embedding methods, with only 4 proof-of-concept methods identified. Furthermore, the review reveals a lack of consensus on outcome measures, emphasizing the need for standardized outcome selection for future evaluations. %M 40117570 %R 10.2196/59209 %U https://www.jmir.org/2025/1/e59209 %U https://doi.org/10.2196/59209 %U http://www.ncbi.nlm.nih.gov/pubmed/40117570 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e56975 %T Effectiveness of Digital Lifestyle Interventions on Depression, Anxiety, Stress, and Well-Being: Systematic Review and Meta-Analysis %A Brinsley,Jacinta %A O'Connor,Edward J %A Singh,Ben %A McKeon,Grace %A Curtis,Rachel %A Ferguson,Ty %A Gosse,Georgia %A Willems,Iris %A Marent,Pieter-Jan %A Szeto,Kimberley %A Firth,Joseph %A Maher,Carol %+ Alliance for Research in Exercise, Nutrition and Activity, University of South Australia, 108 North Terrace, Adelaide, 5000, Australia, 61 8 8302 6558, jacinta.brinsley@unisa.edu.au %K depression %K anxiety %K stress %K well-being %K mental health %K lifestyle intervention %K physical activity %K sleep %K diet %K digital health %K mobile phone %D 2025 %7 20.3.2025 %9 Review %J J Med Internet Res %G English %X Background: There is a growing body of robust evidence to show that lifestyle behaviors influence mental health outcomes. Technology offers an accessible and cost-effective implementation method for interventions, yet the study of the effectiveness of interventions to date has been specific to the mode of delivery, population, or behavior. Objective: The primary aim of this review was to comprehensively evaluate the effectiveness of digital lifestyle interventions for improving symptoms of depression, anxiety, stress, and well-being as coprimary outcomes in adults. The secondary aim was to explore the technological, methodological, intervention-specific, and population-specific characteristics that were associated with major changes in mental health outcomes. Methods: A systematic search was conducted across the MEDLINE, CINAHL, Embase, Emcare, PsycINFO, and Scopus databases to identify studies published between January 2013 and January 2023. Randomized controlled trials of lifestyle interventions (physical activity, sleep, and diet) that were delivered digitally; reported changes in symptoms of depression, anxiety, stress, or well-being in adults (aged ≥18 years); and were published in English were included. Multiple authors independently extracted data, which was evaluated using the 2011 Levels of Evidence from the Oxford Centre for Evidence-Based Medicine. Inverse-variance random-effects meta-analyses were used for data analysis. The primary outcome was the change in symptoms of depression, anxiety, stress, and well-being as measured by validated self-report of clinician-administered outcomes from pre- to postintervention. Subgroup analyses were conducted to determine whether results differed based on the target lifestyle behavior, delivery method, digital features, design features, or population characteristics. Results: Of the 14,356 studies identified, 61 (0.42%) were included. Digital lifestyle interventions had a significant small-to-medium effect on depression (standardized mean difference [SMD] −0.37; P<.001), a small effect on anxiety (SMD −0.29; P<.001) and stress (SMD −0.17; P=.04), and no effect on well-being (SMD 0.14; P=.15). Subgroup analyses generally suggested that effects were similar regardless of the delivery method or features used, the duration and frequency of the intervention, the population, or the lifestyle behavior targeted. Conclusions: Overall, these results indicate that delivering lifestyle interventions via a range of digital methods can have significant positive effects on depression (P<.001), anxiety (P<.001), and stress (P=.04) for a broad range of populations, while effects on well-being are inconclusive. Future research should explore how these interventions can be effectively implemented and embedded within health care with a concerted focus on addressing digital health equity. Trial Registration: PROSPERO CRD42023428908; https://www.crd.york.ac.uk/PROSPERO/view/CRD42023428908 %M 40112295 %R 10.2196/56975 %U https://www.jmir.org/2025/1/e56975 %U https://doi.org/10.2196/56975 %U http://www.ncbi.nlm.nih.gov/pubmed/40112295 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 13 %N %P e55379 %T Proximal Effects of a Just-in-Time Adaptive Intervention for Smoking Cessation With Wearable Sensors: Microrandomized Trial %A Vinci,Christine %A Sutton,Steve K %A Yang,Min-Jeong %A Jones,Sarah R %A Kumar,Santosh %A Wetter,David W %+ , Moffitt Cancer Center, 12902 Magnolia Dr., Tampa, FL, 33612, United States, 1 813 745 5421, Christine.vinci@moffitt.org %K smoking cessation %K mindfulness %K ecological momentary assessment %K micro-randomized trial %K Just-in-Time Adaptive Intervention %K JITAI %K EMA %K ecological momentary %K smoking %K smokers %K quitting %K cessation %K meditation %K mind body %K sensors %K motivational %K tobacco %K nicotine %K NRT %K counseling %K wearables %K abstinence %K stress %K craving %K adaptive intervention %K mobile phone %D 2025 %7 19.3.2025 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Tobacco use remains the leading preventable cause of morbidity and mortality in the United States. Novel interventions are needed to improve smoking cessation rates. Mindfulness-based interventions (MBIs) for cessation address tobacco use by increasing awareness of the automatic nature of smoking and related behaviors (eg, reactivity to triggers for smoking) from a nonjudgmental stance. Delivering MBIs for smoking cessation via innovative technologies allows for flexibility in the timing of intervention delivery, which has the potential to improve the efficacy of cessation interventions. Research shows MBIs target key mechanisms in the smoking cessation process and can be used to minimize drivers of smoking lapse. Objective: This single-arm study investigated the impact of mindfulness-based strategies and motivational messages on proximal outcomes, collected via ecological momentary assessment (EMA), relevant to tobacco abstinence via a microrandomized trial. This approach allows for the evaluation of intervention content on proximal outcomes (eg, reduced negative affect) that are thought to impact positive distal outcomes (eg, smoking abstinence). Methods: All participants were motivated to quit smoking, and the intervention they received included nicotine replacement therapy, brief individual counseling, and a 2-week Just-in-Time Adaptive Intervention (JITAI) with wearable sensors. Throughout the JITAI period, a single strategy was randomly pushed (vs not) multiple times per day through the smartphone application. An EMA next assessed negative affect, positive affect, mindfulness, abstinence self-efficacy, motivation to quit, craving, and smoking motives. The primary analyses evaluated differences in EMA outcomes (proximal) for when a strategy was pushed versus not pushed. Additional analyses evaluated changes in similar outcomes collected from surveys at the baseline and end-of-treatment visits. Results: Participants (N=38) were 63% (24/38) female, 18% (7/38) Hispanic or Latino, and 29% (11/38) African American. They had an average age of 49 years and smoked an average of 15 (SD 7.9) cigarettes per day. Results indicated that receiving the JITAI significantly reduced proximal negative affect in the second (and final) week of the intervention. Self-reports provided at baseline and end of treatment showed significant decreases in perceived stress, automaticity of smoking and craving, and a significant increase in abstinence self-efficacy. Increases in abstinence self-efficacy significantly predicted abstinence. Conclusions: To our knowledge, this is the first study to test the proximal impact of a mindfulness-based JITAI on key variables associated with smoking cessation. Our primary finding was that negative affect was lower following the completion of a strategy (vs when no strategy was delivered) in the final week of the JITAI. Among a larger sample size, future research should extend the length of the intervention to further evaluate the impact of the JITAI, as well as include a comparison condition to further evaluate how each component of the intervention uniquely impacts outcomes. Trial Registration: ClinicalTrials.gov NCT03404596; https://clinicaltrials.gov/study/NCT03404596 %M 40106803 %R 10.2196/55379 %U https://mhealth.jmir.org/2025/1/e55379 %U https://doi.org/10.2196/55379 %U http://www.ncbi.nlm.nih.gov/pubmed/40106803 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e65025 %T Evaluating Perceptions of the CANreduce 2.0 eHealth Intervention for Cannabis Use: Focus Group Study %A Folch-Sanchez,Daniel %A Pellicer-Roca,Maria %A Sestelo,María Agustina %A Zuluaga,Paola %A Arias,Francisco %A Guzmán Cortez,Pablo %A Amechat,Salma %A Gil-Berrozpe,Gustavo %A Lopez Montes,Estefania %A Mercadé,Clara %A Fonseca,Francina %A Miquel,Laia %A Mestre-Pintó,Joan I %+ Health and Addictions Research Group, Addictions Unit, Psychiatry and Psychology Service, Institut Clínic de Neurociències (ICN), Hospital Clinic Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), c villarroel 170, Barcelona, Spain, 34 932275400 ext 1719, miquel@clinic.cat %K addiction %K cannabis %K drug use disorder %K eHealth %K digital health intervention %K qualitative research %K focus groups %K user-centered design %K user-centered intervention %D 2025 %7 19.3.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Cannabis is the most widely used illicit drug, and admissions for cannabis use disorders (CUDs) are increasing globally, posing a significant public health challenge. Despite its negative consequences, a substantial proportion of individuals with problematic use do not seek treatment. In recent years, digital health interventions (DHIs) have emerged as accessible and cost-effective solutions, empowering users to manage their health care. CANreduce is one such eHealth intervention that has demonstrated effectiveness in reducing cannabis use (CU); however, its suboptimal adherence rates underscore the need for strategies to enhance user engagement and motivation. Objective: This study aims to improve the effectiveness, adherence, and user experience of the Spanish version of CANreduce 2.0 by employing focus groups (FGs) within a user-centered design approach that actively involves both users and professionals. Methods: Separate FGs were conducted for users and professionals, involving a total of 10 participants. Users were recruited from individuals registered on the CANreduce 2.0 platform and active cannabis users, while professionals comprised addiction specialists familiar with the platform. Each session was held remotely and moderated by 2 interviewers following a semistructured script. Qualitative analysis of the transcripts was performed using MAXQDA software and content analysis methodology to identify key themes related to the acceptability, usability, and utility of CANreduce 2.0. Results: The qualitative analysis identified 3 main themes, encompassing 15 subcodes. Within the “motivation and awareness” theme, both users (n=6, mean age 31.8 years, SD 4.1 years) and professionals (n=4, mean age 37.25 years, SD 1.71 years) frequently discussed the importance of “motivation” and “problem awareness” as crucial for the success of CANreduce 2.0. In the “guidance and use” theme, the subcode “complement to face-to-face therapy” was the most emphasized. Professionals supported CANreduce 2.0 as a valuable adjunct to in-person therapy, serving as both an educational and monitoring tool, with no objections raised by either group. Lastly, within the “content and design” theme, “information,” “small achievements,” and “personalized content” emerged as key areas for improvement, highlighting the need to enhance motivation and adherence through gamification and tailored content. Conclusions: Personalization, robust motivational strategies, and an engaging, interactive design are essential for the success of DHIs, particularly in addiction treatment. Collaboration among technology developers, health care professionals, and users should be central to the development process, fostering the cocreation of practical and effective solutions that are responsive to the needs of those seeking treatment. This approach ensures that DHIs are not only functional but also widely accepted and impactful. Insights from this study will inform the ongoing refinement of CANreduce 2.0, enhancing its relevance and effectiveness in addressing CU. %M 40106809 %R 10.2196/65025 %U https://www.jmir.org/2025/1/e65025 %U https://doi.org/10.2196/65025 %U http://www.ncbi.nlm.nih.gov/pubmed/40106809 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e56227 %T Behavioral Therapy–Based Digital Interventions for Treating Osteoarthritis: Systematic Review and Meta-Analysis %A Zhu,Beiyao %A Zhu,Dian %A Xue,Xiao'ao %A Yang,Hongyi %A Zhang,Shurong %+ Department of Sports Medicine, Huashan Hospital, Fudan University, No 12 Urumqi Middle Road, Jing'an District, Shanghai, 200040, China, 86 18901626266, zhangshurong@huashan.org.cn %K osteoarthritis %K digital intervention %K behavioral therapy %K treatment %K systematic review %K meta-analysis %K pain %K impairment %K quality of life %K socioeconomic burden %K psychotherapy-based digital intervention %K patient %K pain reduction %D 2025 %7 19.3.2025 %9 Review %J J Med Internet Res %G English %X Background: Osteoarthritis (OA) is characterized by pain, functional impairments, muscle weakness, and joint stiffness. Since OA heightens reliance on heath care resources and exacerbates socioeconomic burden, remote OA rehabilitation using digital technologies is rapidly evolving. Objective: The aim of this study was to analyze the efficacy of behavioral therapy–based digital interventions for patients with OA. Methods: This study is a systematic review of randomized controlled trials (RCTs) that assessed the effects of behavioral therapy–based digital intervention tools for OA. These RCTs were searched from inception to June 2023 in the Web of Science, Embase, Cochrane Library, Ovid, and PubMed databases. Results: Ten eligible RCTs comprising 1895 patients with OA were included. Digital tools based on either cognitive behavioral therapy (CBT) or behavior change technique (BCT) were investigated. All studies demonstrated low-to-moderate effects on pain reduction in the short term (standardized mean difference [SMD] –0.20, 95% CI –0.35 to –0.05). Six studies reported improvement in physical function (SMD –0.20, 95% CI –0.41 to 0.00), and 5 confirmed increased pain self-efficacy (SMD 0.22, 95% CI 0.02-0.42). In subgroup analysis, compared with CBT, BCT-based digital interventions demonstrated their effects on pain reduction (SMD –0.25, 95% CI –0.49 to 0.00) and physical function (SMD –0.26, 95% CI –0.54 to –0.01) in the short term. In addition, physiotherapist involvement in treatment had a positive effect on pain control (SMD –0.14, 95% CI –0.27 to –0.02). Furthermore, web-based digital tools improved physical function in the short term (SMD –0.28, 95% CI –0.54 to –0.01). Conclusions: Moderate- and low-quality evidence supported that behavioral therapy–based digital tools improved pain intensity, physical function, and self-efficacy in the short term. However, affective interactions between patients and professionals may affect the clinical outcomes. Trial Registration: PROSPERO CRD42023430716; https://tinyurl.com/yc49vzyy %M 40106814 %R 10.2196/56227 %U https://www.jmir.org/2025/1/e56227 %U https://doi.org/10.2196/56227 %U http://www.ncbi.nlm.nih.gov/pubmed/40106814 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e67049 %T Integration of a Patient-Centered mHealth Intervention (Support-Moms) Into Routine Antenatal Care to Improve Maternal Health Among Pregnant Women in Southwestern Uganda: Protocol for a Randomized Controlled Trial %A Atukunda,Esther Cathyln %A Mugyenyi,Godfrey Rwambuka %A Haberer,Jessica E %A Siedner,Mark J %A Musiimenta,Angella %A Najjuma,Josephine N %A Obua,Celestino %A Matthews,Lynn T %+ Mbarara University of Science and Technology, P.O Box 1410, Mbarara, Uganda, 256 702949832, eatukunda@must.ac.ug %K social support %K intervention development %K maternal health %K antenatal care attendance %K skilled births %K Uganda %D 2025 %7 19.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Mobile health (mHealth) interventions that leverage social support (SS) can improve partner involvement and pregnancy experiences and promote antenatal care (ANC) attendance and skilled births. In our previous studies, we used behavioral frameworks to develop a user-centered mHealth-based, audio SMS text messaging app to support pregnant individuals to use maternity care services in rural Uganda (Support-Moms app). In our pilot study, we observed high intervention uptake, acceptability, and feasibility, as well as increased ANC attendance and skilled births. Objective: With the promising pilot data, we propose a type 1 hybrid implementation-effectiveness trial to test if this novel patient-centered automated and customized mHealth-based SS intervention is effective and cost-effective enough to warrant future large-scale implementation into Uganda’s routine maternity care. Methods: We will physically recruit 824 pregnant women at <20 weeks of gestation living in Mbarara and Mitooma districts, southwestern Uganda, and randomize them (1:1) to receive standard of care or the Support-Moms app, with at least 2 of their identified social supporters. Our primary outcome will be the proportion of skilled births. Secondary outcomes will include number of ANC visits, institution-based delivery, mode of infant delivery, preterm birth, birth weight, SS, obstetric complications, and deaths (maternal, fetal, and newborn). We will assess other implementation, service, and client outcomes through study records, the mHealth platform, and questionnaires with all women in the intervention, their social supporters, health care providers (HCPs), and managers from participating facilities. We will conduct face-to-face in-depth exit interviews with 30 purposively selected intervention participants and 15 facility HCPs and managers to explore implementation strategies for scale-up. Annual maternity resource allocations, costs, number of ANC visits, and deliveries will be assessed from facility records up to 36 months after implementation. We will estimate incremental cost-effectiveness ratios concerning cost per additional HCP-led delivery, per death averted, and per quality-adjusted life year gained as cost-effectiveness measures. Results: This study was funded in September 2023. Ethics approval was obtained in February 2024, and actual data collection started in March 2024. As of January 2025, 75% (618/824) of all projected study participants provided consent and were recruited into the study. Participants are expected to be followed up until delivery, and 15% (124/824) have so far exited. Data analysis for the trial is expected to start as soon as the last participant exits from the study. The qualitative interviews will start in April 2025, and data will be analyzed and published as soon as data collection is done, which is expected in March 2027. Conclusions: We are testing the feasibility, acceptability, and cost-effectiveness of implementing Support-Moms into routine maternity care from individual and facility perspectives. We hypothesize that Support-Moms will be an effective and cost-effective strategy to improve maternity service use for women in rural Uganda and similar settings. Trial Registration: ClinicalTrials.gov NCT05940831; https://clinicaltrials.gov/study/NCT05940831 International Registered Report Identifier (IRRID): DERR1-10.2196/67049 %M 40105879 %R 10.2196/67049 %U https://www.researchprotocols.org/2025/1/e67049 %U https://doi.org/10.2196/67049 %U http://www.ncbi.nlm.nih.gov/pubmed/40105879 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e69264 %T Evaluation of a Smartphone-Based Weight Loss Intervention with Telephone Support for Merchant Women With Obesity in Côte d'Ivoire: Protocol for a Randomized Controlled Trial %A Usui,Rui %A Aomori,Maki %A Kanamori,Shogo %A Watabe,Setsuko %A Sehi,Bi Tra Jamal %A Kawano,Kei %A Kanoya,Yuka %+ Department of Nursing, Shonan University of Medical Science, 27, Yamatecho, Naka-ku, Yokohama, Kanagawa, 231-0862, Japan, 81 45 222 0810, usuir@yokohama-cu.ac.jp %K West Africa %K sub-Saharan Africa %K obesity %K noncommunicable diseases %K mHealth %K mobile health %K eHealth %K randomized controlled trial %K Côte d'Ivoire %K weight loss program %D 2025 %7 18.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: The obesity rate among women in Côte d'Ivoire is rising, particularly in urban areas. Merchantry is the leading occupation for women in the country, and merchant women face a high risk of obesity owing to their sedentary lifestyle. A previous survey indicated that the obesity rate among merchant women was 30%, double the national average. Furthermore, 82.2% of merchant women with obesity were unaware of their condition, and 40.1% expressed no interest in losing weight. While most weight loss programs target individuals ready to lose weight, community interventions should also address those with minimal readiness. Additionally, low-cost weight-loss interventions that do not require health professionals are needed in countries with limited medical resources. Smartphones could offer a cost-effective solution as they enable self-monitoring and remote communication. Objective: This study will evaluate a low-cost smartphone-based intervention that targets individuals who are not ready to lose weight without the involvement of health professionals. Methods: The intervention will run for 6 months, and its efficacy will be assessed in an unblinded, parallel-group, randomized controlled trial with 108 participants per group. All direct interventions for participants in this study will be carried out by staff without medical qualifications. The intervention group will receive weighing scales and be encouraged to record their weight with a smartphone app. Health education will be provided via weekly group messages and monthly phone calls. The evaluation will be conducted face-to-face. The primary outcome will be the weight change, and the secondary outcome will be differences in body fat percentage, abdominal circumference, and stage of behavioral change in weight loss behaviors from baseline to 3, 6, and 12 months. Results: In accordance with this protocol, the recruitment of participants started on August 26, 2024. A total of 216 participants were allocated, with 108 in the intervention group and 108 in the control group. The baseline survey began on November 15, 2024, and is currently ongoing as of the end of November 2024. Conclusions: This study will be the first in sub-Saharan African countries to implement a smartphone app-based weight loss program in sub-Saharan Africa that does not require direct intervention by health care professionals but specifically targets communities. Furthermore, if the effectiveness of this program is confirmed, it has the potential to serve as a low-cost sustainable weight loss model at the policy level. International Registered Report Identifier (IRRID): DERR1-10.2196/69264 %M 40101743 %R 10.2196/69264 %U https://www.researchprotocols.org/2025/1/e69264 %U https://doi.org/10.2196/69264 %U http://www.ncbi.nlm.nih.gov/pubmed/40101743 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e69100 %T Patients’ Experiences of Digital Health Interventions for the Self-Management of Chronic Pain: Systematic Review and Thematic Synthesis %A Main,Ashleigh %A McCartney,Haruno %A Ibrar,Maryam %A Muirhead,Fiona %A Mavroeidi,Alexandra %A Rai,Harleen Kaur %A Maguire,Roma %+ Department of Computer and Information Sciences, University of Strathclyde, Livingston Tower, 26 Richmond Street, Glasgow, G1 1XH, United Kingdom, 44 0141 552 4400, ashleigh.main@strath.ac.uk %K chronic pain %K digital health %K digital tool %K digital health intervention %K mobile health %K mHealth %K eHealth %K self-management %K pain management %K person-centered %K patient experiences %K systematic review %K thematic synthesis %D 2025 %7 18.3.2025 %9 Review %J J Med Internet Res %G English %X Background: Research regarding the effectiveness of digital health interventions (DHIs) for people living with chronic pain is widely documented, although it is often measured against changes in clinical outcomes. To gain a comprehensive understanding of the full impact of DHIs, it is vital to understand the experience of individuals who are using them. An exploration of qualitative data regarding the experience of people living with chronic pain engaging with DHIs could provide a more in-depth account of how individuals interact and engage with such tools, uncovering the overall impact DHIs can have on the lives of people living with chronic pain. Objective: This qualitative systematic review and thematic synthesis aimed to appraise and synthesize relevant qualitative evidence on patients’ experiences of engaging with DHIs for the self-management of chronic pain symptoms. Methods: A systematic literature search of qualitative and mixed methods studies published between 2013 and 2023 was conducted across 6 databases: MEDLINE, PubMed, Embase, CINAHL, PsycINFO, and Scopus. Eligible studies included adult patients aged ≥18 years with a chronic pain diagnosis (ie, >12 weeks) reporting on the experience of engaging in a DHI for the self-management of chronic pain. The Critical Appraisal Skills Program checklist for qualitative research was used to appraise each study. Following a 3-step inductive thematic synthesis approach, the researcher performed line-by-line coding of each eligible article to identify descriptive themes. Through iterative evaluation of the descriptive themes, analytical themes that facilitated a deeper understanding of the data were derived. Results: In total, 37 qualitative and mixed methods studies were included in the review. Thematic synthesis revealed three overarching themes encompassing five subthemes: (1) personal growth, with 2 subthemes (gaining new insights and renewed mindset); (2) active involvement, with 3 subthemes (motivation, improved access, and health care decision-making); and (3) connectedness and support. Conclusions: A positive experience with DHIs among people living with chronic pain is achieved through an improved understanding of their condition, greater self-awareness of how symptoms impact their lives, and an increase in motivation to play an active role in their health care. DHIs promote the confidence and independence of people living with chronic pain, as well as facilitate a sense of ongoing support between routine appointments. However, DHIs may disempower people living with chronic pain by placing too much focus on their pain and should be used as an adjunct to existing care as opposed to replacing in-person appointments. To appropriately meet the needs of people living with chronic pain, the content and features of DHIs should be personalized. Development of future DHIs should use a co-design approach involving key stakeholders to ensure the needs of people living with chronic pain are met. Trial Registration: PROSPERO CRD42023445100; https://www.crd.york.ac.uk/PROSPERO/view/CRD42023445100 International Registered Report Identifier (IRRID): RR2-10.2196/52469 %M 40101209 %R 10.2196/69100 %U https://www.jmir.org/2025/1/e69100 %U https://doi.org/10.2196/69100 %U http://www.ncbi.nlm.nih.gov/pubmed/40101209 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e66294 %T Digital Physical Activity and Sedentary Behavior Interventions for Community-Living Adults: Umbrella Review %A Russell,Eilidh %A Kirk,Alison %A Dunlop,Mark D %A Hodgson,William %A Patience,Mhairi %A Egan,Kieren %+ , Department of Computer and Information Sciences, University of Strathclyde, 26 Richmond Street, Glasgow, G1 1XH, United Kingdom, 44 01415524400, eilidh.russell.2017@uni.strath.ac.uk %K physical activity %K sedentary behavior %K digital health interventions %K behavior change %K theoretical frameworks %K umbrella review %K mobile phone %K community-living adults %D 2025 %7 18.3.2025 %9 Review %J J Med Internet Res %G English %X Background: Digital interventions hold significant potential for improving physical activity (PA) and reducing sedentary behavior (SB) in adults. Despite increasing interest, there remain surprising gaps in the current knowledge of how best to deliver these interventions, including incorporating appropriate theoretical frameworks and behavior change techniques. Following numerous systematic reviews, there is now significant potential for umbrella reviews to provide an overview of the current evidence. Objective: This umbrella review aimed to explore digital PA and SB interventions for community-living adults across effectiveness, key components, and methodological quality. Methods: This review followed the Joanna Briggs Institute framework for umbrella reviews. Key search terms were developed iteratively, incorporating physical and sedentary activity alongside digital interventions. We searched 7 online databases (Web of Science Core Collection, CINAHL, APA PsycINFO, Inspec, the Cochrane Library, MEDLINE [Ovid], and PROSPERO) alongside gray literature databases. Information was extracted and tabulated from each included article on intervention effectiveness, key components, and content acknowledging both the digital and human elements. The study quality was appraised using A Measurement Tool to Assess systematic Reviews 2 (AMSTAR 2). The corrected covered area method was used to assess the overlap of primary studies included in the systematic reviews. All relevant research findings were extracted and reported. Results: Search terms identified 330 articles, of which 5 (1.5%) met the inclusion criteria. The most common PA outcomes identified were daily steps, moderate-to-vigorous PA, total PA, and PA change. Reviews with meta-analysis reported that digital interventions improved multiple PA outcomes (daily steps, moderate-to-vigorous PA time, and total PA time). However, findings from the remaining systematic reviews were mixed. Similarly, the findings for SB were contrasting. Regarding intervention components, monitor- and sensor-only intervention delivery methods were most frequently implemented. Eleven theoretical frameworks were identified, with social cognitive theory being the most prominent theory. In total, 28 different behavior change techniques were reported, with goal setting, self-monitoring, feedback, and social support being the most frequently used. All 5 systematic reviews were of low or critically low quality, each incorporating unique primary studies (corrected covered area=0%). Conclusions: This umbrella review highlights the potential of digital interventions to increase PA and reduce SB among community-living adults. However, the disparate nature of current academic knowledge means potentially efficacious research may not realistically translate to real work impact. Our review identified a lack of consensus around outcomes and components at both individual (eg, difficult to collate and compare findings) and multiple study (poor reported quality of systematic reviews) levels. Collective, concerted action is required to standardize outcomes and improve systematic review reporting to optimize future learning around digital interventions to increase PA and reduce SB in community-living adults, including traditionally overlooked populations, like informal carers. Trial Registration: PROSPERO CRD42023450773; https://www.crd.york.ac.uk/PROSPERO/view/CRD42023450773 %M 40100250 %R 10.2196/66294 %U https://www.jmir.org/2025/1/e66294 %U https://doi.org/10.2196/66294 %U http://www.ncbi.nlm.nih.gov/pubmed/40100250 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e69204 %T Enhancing Digital Health Interventions for Medication Adherence: Considerations for Broader Applicability and Long-Term Impact %A Du,ShanShan %A Zhao,Yining %+ Renhe Rehabilitation Hospital, Renhe Street, Hubei, China, 86 15767853433, 1547838432@qq.com %K mobile apps %K digital health %K atrial fibrillation %K anticoagulants %K medication adherence %K mobile phone %D 2025 %7 14.3.2025 %9 Letter to the Editor %J J Med Internet Res %G English %X %R 10.2196/69204 %U https://www.jmir.org/2025/1/e69204 %U https://doi.org/10.2196/69204 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e50178 %T Examining Challenges to Co-Design Digital Health Interventions With End Users: Systematic Review %A Duffy,Anthony %A Boroumandzad,Nazanin %A Sherman,Alfredo Lopez %A Christie,Gregory %A Riadi,Indira %A Moreno,Sylvain %+ School of Interactive Arts & Technology, Simon Fraser University, 13450 102 Ave #250, Surrey, BC, V3T 0A3, Canada, 1 (778) 782 9742, sylvain_moreno@sfu.ca %K digital health %K end users %K user experience %K health behavior %K intervention %K co-design %K mobile health %K mHealth %K digital health citizen %D 2025 %7 14.3.2025 %9 Review %J J Med Internet Res %G English %X Background: Digital health interventions (DHIs) are changing the dynamic of health care by providing personalized, private, and instantaneous solutions to end users. However, the explosion of digital health has been fraught with challenges. The approach to co-design with end users varies across a diverse domain of stakeholders, often resulting in siloed approaches with no clear consensus. The concept of validating user experiences contrasts greatly between digital stakeholders (ie, user experience and retention) and health stakeholders (ie, safety and efficacy). Several methodologies and frameworks are being implemented to address this challenge to varying degrees of success. Objective: We aimed to broadly examine the advancements and challenges to co-design DHIs with end users over the last decade. This task was undertaken to identify the key problem areas at the domain level, with the ultimate goal of creating recommendations for better approaches to co-design DHIs with end users. Methods: We conducted a systematic search of key databases for co-design studies involving end users in DHIs. Searches were divided into 3 relevant streams: health behavior, user experience, and digital methodologies and frameworks. The eligibility criteria were guided by the PerSPEcTiF framework and the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) checklist. In line with this framework, studies were included in this review that (1) address research on DHIs; (2) focus on interaction and co-design with end users; (3) explain results such that uptake, effectiveness, satisfaction, and health outcomes are discernible, positively or negatively; and (4) describe actionable procedures for better DHI design. The search was conducted in a diverse group of 6 bibliographical databases from January 2015 to May 2024: PsycINFO, PubMed (MEDLINE), Web of Science, CINAHL, Institute of Electrical and Electronics Engineers Xplore, and Scopus. From the 13,961 studies initially screened for titles and abstracts, 489 (3.6%) were eligible for a full-text screening, of which 171 (1.2%) studies matched the inclusion criteria and were included in a qualitative synthesis. Results: Of the 171 studies analyzed across 52 journals, we found 5 different research approaches, spanning 8 different digital health solution types and 5 different design methodologies. These studies identified several core themes when co-designing with end users: advancements, which included participatory co-design; challenges, which included participatory co-design, environment and context, testing, and cost and scale; and gaps, which included a pragmatic hybridized framework and industry implementability. Conclusions: This research supports a pragmatic shift toward using mixed methods approaches at scale, methods that are primed to take advantage of the emerging big data era of digital health co-design. This organic outlook should blend the vision of digital health co-designers with the pragmatism of Agile design methodology and the rigor of health care metrics. Trial Registration: PROSPERO CRD42021238164; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021238164 International Registered Report Identifier (IRRID): RR2-10.2196/28083 %M 40085834 %R 10.2196/50178 %U https://www.jmir.org/2025/1/e50178 %U https://doi.org/10.2196/50178 %U http://www.ncbi.nlm.nih.gov/pubmed/40085834 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 13 %N %P e59570 %T The Role of Environmental Factors in Technology-Assisted Physical Activity Intervention Studies Among Older Adults: Scoping Review %A Jansen,Carl-Philipp %A Nijland,Désirée %A Oppert,Jean-Michel %A Alcan,Veysel %A Keskinen,Kirsi E %A Matikainen-Tervola,Emmi %A Pajalic,Zada %A Rantakokko,Merja %A Tomsone,Signe %A Tuomola,Essi-Mari %A Portegijs,Erja %A Timmermans,Erik J %+ Geriatric Center, Medical Faculty Heidelberg, Heidelberg University, Rohrbacherstrasse 149, Heidelberg, 69126, Germany, 49 6221 319 1760, Carl-Philipp.Jansen@med.uni-heidelberg.de %K environmental factors %K intervention %K older adults %K physical activity %K technology %K PRISMA %D 2025 %7 13.3.2025 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: The rapidly emerging integration of both technological applications and environmental factors in physical activity (PA) interventions among older adults highlights the need for an overarching investigation. Objective: This scoping review compiled the current literature and aimed to provide an overview of the role of physical, social, socioeconomic, and systemic environmental factors in technology-assisted PA interventions for older adults. Methods: We systematically searched 6 common databases up to September 16, 2024, for original longitudinal studies (with at least one preintervention measurement and one postintervention measurement) that reported on the role of environmental factors in technology-assisted PA interventions for independently living, community-dwelling older adults. In a stepwise process, data on study characteristics (step 1), environmental factors and their role in the included studies (step 2), and intervention outcomes and effects by type of environmental factor (step 3) were summarized. Results: A total of 8020 articles were screened, and 25 (0.31%) were included. Most studies were conducted in Europe (11/25, 44%), followed by North America (5/25, 20%), Asia (5/25, 20%), and Oceania (4/25, 16%). Social environmental factors were most often considered (19/25, 76%), followed by factors from the physical (8/25, 32%), socioeconomic (1/25, 4%), and systemic environment (1/25, 4%). Environmental factors were used as the outcome (8/25, 32%), setting variable (7/25, 28%), moderator or facilitator (8/25, 32%), and intervention component (3/25, 12%). In most studies (19/25, 76%), the intervention had a beneficial effect on the outcome of interest, and the included environmental factor played a supportive role in achieving this effect. In some studies, no effect (3/25, 12%), mixed effects (2/25, 8%), or adverse effects (1/25, 4%) of the interventions were reported. Conclusions: This is the first comprehensive description of how environmental factors interact with technology-assisted interventions to increase or optimize PA in older adults. It was found that the investigation of environmental factors in this field is at an early stage. Environmental factors were found to play a supportive role in achieving beneficial effects of technology-assisted PA interventions, but the findings were based on a heterogeneous empirical platform. Still, certain aspects such as the application of virtual reality environments and social (or peer) comparison have shown significant potential that remains to be leveraged. A better understanding of intervention results and support in tailoring intervention programs can be provided through the inclusion of environmental aspects in technology-assisted PA interventions for older adults. %M 40080814 %R 10.2196/59570 %U https://mhealth.jmir.org/2025/1/e59570 %U https://doi.org/10.2196/59570 %U http://www.ncbi.nlm.nih.gov/pubmed/40080814 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e65391 %T BePresent Universal Internet-Based Parenting Intervention: Single-Arm Pre-Post Intervention Study %A Mishina,Kaisa %A Baumel,Amit %A Kinnunen,Malin %A Ristkari,Terja %A Heinonen,Emmi %A Hinkka-Yli-Salomäki,Susanna %A Sourander,Andre %+ Research Centre for Child Psychiatry, Faculty of Medicine, University of Turku, Lemminkäisenkatu 3, Turku, 20014, Finland, 358 50 310 135, kaemka@utu.fi %K parent training %K universal intervention %K online intervention %K irritability %K conduct problems %K hyperactivity %K preschool %K mental health %K strongest families %K positive parenting %K parenting skills %K parent-child relationships %K parent satisfaction %K BePresent %K feasibility study %K single-arm pre-post intervention study %D 2025 %7 13.3.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-based parenting programs have great potential to promote positive parent-child relationships as well as to reach and engage parents. Objective: This study aimed to assess the universal internet-based BePresent parenting intervention for families with 3-year-old children and how it influences the child’s behavior and daily-life situations assessed by parents. The first aim of the study was to assess the change from baseline to follow-up in child hyperactivity and conduct problems, affective reactivity, and daily activities. The second aim was to assess intervention completion rates. The third aim was to evaluate parent satisfaction with the intervention. The fourth aim was to assess all outcomes by comparing those who completed the intervention and those who did not. Methods: We conducted a single-arm pre- and postintervention study. Parents attending their child’s 3-year health check-up were recruited from children’s health clinics. The intervention was an unguided internet-based parenting program consisting of 5 modules. Self-reported measures were collected at baseline and at an 8-week follow-up. Linear mixed-effects models were used to analyze the changes from baseline to follow-up. Results: Altogether, 752 parents registered, and 515 started the intervention. Of those, 36% (n=183) completed the intervention. Parents reported high satisfaction with the intervention: the majority (68.8%–84.9%) were satisfied with various aspects of the program, and 89.9% said the intervention provided information about positive parenting skills. The findings show significant decreases with small effect sizes in parents’ ratings of child hyperactivity (P=.03; d=0.12) and conduct problems (P=.001; d=0.20) between baseline and the 8-week follow-up. A similar finding was observed in the parent ratings of child irritability (P≤.001; d=0.27) using the Affective Reactivity Index. Parents reported improvement in the daily functioning of their child when it was measured with a questionnaire adapted from the Barkley Home Situations Questionnaire (P=.01; d=0.14). Conclusions: Universal digital interventions have the potential to be implemented widely in community settings to improve knowledge and positive parenting skills. However, there is a need to assess the efficacy of digital universal interventions using randomized controlled designs and to examine additional ways to increase adherence to universal programs. %M 40080811 %R 10.2196/65391 %U https://www.jmir.org/2025/1/e65391 %U https://doi.org/10.2196/65391 %U http://www.ncbi.nlm.nih.gov/pubmed/40080811 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e57470 %T Effect of SMS Ward Round Notifications on Inpatient Experience in Acute Medical Settings: Retrospective Cohort Study %A Lee,Jongchan %A Ahn,Soyeon %A Ohn,Jung Hun %A Kim,Eun Sun %A Lim,Yejee %A Kim,Hye Won %A Park,Hee-Sun %A Cho,Jae Ho %A Kim,Sun-wook %A Ryu,Jiwon %A Kim,Jihye %A Jang,Hak Chul %A Kim,Nak-Hyun %K rounds %K round-time notification %K text messaging %K patient experience assessment %K patient experiences %K patient-centeredness %K patient participation %D 2025 %7 12.3.2025 %9 %J JMIR Hum Factors %G English %X Background: Ward rounds are an essential component of inpatient care. Patient participation in rounds is increasingly encouraged, despite the occasional complicated circumstances, especially in acute care settings. Objective: This study aimed to evaluate the effect of real-time ward round notifications using SMS text messaging on the satisfaction of inpatients in an acute medical ward. Methods: Since January 2021, a service implementing real-time ward round notifications via text messaging (WR-SMS) has been operational at a tertiary-care medical center in Korea. To assess its impact, we conducted a retrospective cohort study of patients admitted to the acute medical unit who participated in a patient experience survey. Patient satisfaction was compared between patients admitted in 2020 (pre–WR-SMS group) and 2021 (post–WR-SMS group). Results: From January 2020 to December 2021, a total of 100 patients were enrolled (53 patients in the pre–WR-SMS group and 47 patients in the post–WR-SMS group). Compared with the pre–WR-SMS group, the post–WR-SMS group showed significantly greater satisfaction about being informed about round schedules (mean 3.43, SD 0.910 vs mean 3.89, SD 0.375; P<.001) and felt more emotionally supported during admission (mean 3.49, SD 0.800 vs mean 3.87, SD 0.397; P<.001). Regarding other questionnaire scores, the post–WR-SMS group showed an overall, although statistically insignificant, improvement compared with the pre–WR-SMS group. Conclusions: Real-time round notifications using a user-friendly SMS may improve inpatient satisfaction effectively. %R 10.2196/57470 %U https://humanfactors.jmir.org/2025/1/e57470 %U https://doi.org/10.2196/57470 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e60436 %T Coach-Assisted eHealth With Group or Individual Support for Employees With Obesity: Randomized Controlled Trial on Weight, Body Composition, and Health Metrics %A Männistö,Siniriikka A %A Pietiläinen,Kirsi H %A Muotka,Joona %A Suojanen,Laura-Unnukka %A Lappalainen,Raimo %A Korpela,Riitta %+ HealthyWeightHub, Endocrinology, Abdominal Center, Helsinki University Hospital and University of Helsinki, Tukholmankatu 8F, Helsinki, 00290, Finland, 358 442351020, siniriikka.mannisto@helsinki.fi %K eHealth %K weight loss %K acceptance and commitment therapy %K weight-neutral %K Healthy Weight Coaching %K occupational health %K digital health %K body composition %K obesity %K psychobehavioral %K intervention %K health care %K metabolic health %K physiological change %D 2025 %7 12.3.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Acceptance and commitment therapy provides a psychobehavioral framework feasible for digital and hybrid weight loss interventions. In face-to-face studies, group-based interventions yield more favorable outcomes than individual interventions, but the effect of the intervention form has not been studied in combination with eHealth. Objective: This study investigated whether a minimal, 3-session group or individual enhancement could provide additional benefits compared to an eHealth-only intervention when assessing weight, body composition, and laboratory metrics in a sample of occupational health patients with obesity. Methods: This study was a randomized controlled trial with a 12-month intervention, followed by a 12-month follow-up period without additional support (March 2021 to March 2023). Recruited from occupational health care for Finnish municipal employees, 111 working-age adults with a BMI of 30-40 kg/m2 were randomized to 1 of the 3 treatment arms: eHealth, eHealth+group, or eHealth+individual. All treatment arms received a web-administrated, coach-assisted eHealth program based on acceptance and commitment therapy, and additionally, the eHealth+group and eHealth+individual arms received 3 remotely facilitated group or individual meetings with their designated coach. The participants were assessed for weight, body composition, blood pressure, and laboratory measurements at 0-, 6-, 12-, and 24-month time points. Applying estimated means to decrease bias caused by dropouts, generalized estimating equations were used to study the differences between the 3 groups over time. Results: There were no between-group differences in primary measurements of weight change or categorical weight change. Secondary outcomes also did not show changes attributable to the intervention arm. Across the entire sample, the total weight loss was 1.5% during the intervention, with 18% (20/111) of the participants attaining a ≥5% weight loss. Sustained at follow-up, waist circumference decreased, and high-density lipoprotein cholesterol increased slightly. The participants completed, on average, 58.6% of the eHealth program. Conclusions: There were no differences in weight or other somatic health variables between the eHealth arm and intervention combining eHealth with minimal group or individual enhancement. Despite a modest overall weight loss, the intervention shows promise in improving body composition and metabolic health. Moving forward, further research is needed to determine if there is a threshold where face-to-face meetings provide additional benefits in hybrid interventions. Moreover, there is a need to explore for whom and under what conditions eHealth and hybrid models may be most effective. Trial Registration: ClinicalTrials.gov NCT04785586; https://clinicaltrials.gov/study/NCT04785586 %M 40073400 %R 10.2196/60436 %U https://www.jmir.org/2025/1/e60436 %U https://doi.org/10.2196/60436 %U http://www.ncbi.nlm.nih.gov/pubmed/40073400 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e67051 %T Novel Smartphone App and Supportive Accountability for the Treatment of Childhood Disruptive Behavior Problems: Protocol for a Randomized Controlled Trial %A Lindhiem,Oliver %A Tomlinson,Claire S %A Kolko,David J %A Silk,Jennifer S %A Hafeman,Danella %A Wallace,Meredith %A Setiawan,I Made Agus %A Parmanto,Bambang %+ , University of Pittsburgh, 3811 O'Hara St., Pittsburgh, PA, 15213, United States, 1 412 246 5909, lindhiemoj@upmc.edu %K mobile health %K disruptive behaviors %K parent management training %K randomized controlled trial %K externalizing behavior %D 2025 %7 11.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Although evidence-based treatments have been developed for childhood behavior problems, many families encounter barriers to treatment access and completion (eg, local availability of services, transportation, cost, and perceived stigma). Smartphone apps offer a cost-efficient method to deliver content to families. Objective: The aim of this study is to evaluate the effectiveness of the UseIt! mobile health system as both stand-alone and coach-assisted interventions via a randomized controlled trial. The UseIt! System is designed to reduce disruptive behaviors in young children. Methods: A nationwide sample of parents of children aged 5 years to 8 years with disruptive behaviors (N=324 dyads) are randomly assigned to the stand-alone app (UseIt!; n=108), the coach-assisted app (UseIt! plus supportive accountability; n=108), or the control app (mindfulness app; n=108). The UseIt! App provides parents with tools and troubleshooting to address disruptive behaviors, along with a behavior diary to track behaviors and strategies over time. The coach-assisted condition includes a bachelor’s level paraprofessional who provides weekly phone calls to promote engagement with the app. The control condition is composed of a mindfulness app. The web-based, self-assessed outcome measures (post treatment and 6-month follow-up) include measures of app usage, parenting knowledge (eg, knowledge of parent management training and cognitive behavioral therapy skills), and strategies (use of evidence-based parenting strategies), symptom reduction (eg, behavior problems), and parent mental health (eg, anxiety, stress, and depression). We hypothesize that both intervention conditions will show greater parent knowledge and use of skills along with greater symptom reduction relative to the control condition. Further, we hypothesize that those assigned to the coach assisted condition will report greater knowledge, skill use, and symptom reduction than the stand-alone app. We will use intent-to-treat analyses to regress outcomes on study conditions to evaluate for differences across conditions. Results: Recruitment of study participants began in December of 2022 and is ongoing. We have recruited over half of our intended sample of 324 parent-child dyads (n=214) as of December 2024. These dyads have been randomly allocated to each of the intervention conditions, with 71 assigned to the coach-assisted condition, 72 assigned to the stand-alone app, and 71 assigned to the control app condition. Data collection is projected to be completed by late 2026. Conclusions: The current study aims to address a gap in the literature regarding the feasibility, effectiveness, and utility of a smartphone app that includes a coach-assisted arm. Digital therapeutics have the potential to enhance the reach and scalability of skills-based psychosocial interventions. Findings from this study will advance scientific knowledge and have implications for clinical practice. Trial Registration: ClinicalTrials.gov NCT05647772; https://clinicaltrials.gov/study/NCT05647772 International Registered Report Identifier (IRRID): DERR1-10.2196/67051 %M 40068698 %R 10.2196/67051 %U https://www.researchprotocols.org/2025/1/e67051 %U https://doi.org/10.2196/67051 %U http://www.ncbi.nlm.nih.gov/pubmed/40068698 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e57649 %T The State of the Art of eHealth Self-Management Interventions for People With Chronic Obstructive Pulmonary Disease: Scoping Review %A te Braake,Eline %A Vaseur,Roswita %A Grünloh,Christiane %A Tabak,Monique %+ Roessingh Research and Development, Roessinghbleekseweg 33b, Enschede, 7522 AH, The Netherlands, 31 0880875734, e.tebraake@rrd.nl %K eHealth %K self-management %K interventions %K chronic obstructive pulmonary disease %K COPD %K review %D 2025 %7 10.3.2025 %9 Review %J J Med Internet Res %G English %X Background: Chronic obstructive pulmonary disease (COPD) is a common chronic incurable disease. Treatment of COPD often focuses on symptom management and progression prevention using pharmacological and nonpharmacological therapies (eg, medication, inhaler use, and smoking cessation). Self-management is an important aspect of managing COPD. Self-management interventions are increasingly delivered through eHealth, which may help people with COPD engage in self-management. However, little is known about the actual content of these eHealth interventions. Objective: This literature review aimed to investigate the state-of-the-art eHealth self-management technologies for COPD. More specifically, we aimed to investigate the functionality, modality, technology readiness level, underlying theories of the technology, the positive health dimensions addressed, the target population characteristics (ie, the intended population, the included population, and the actual population), the self-management processes, and behavior change techniques. Methods: A scoping review was performed to answer the proposed research questions. The databases PubMed, Scopus, PsycINFO (via EBSCO), and Wiley were searched for relevant articles. We identified articles published between January 1, 2012, and June 1, 2022, that described eHealth self-management interventions for COPD. Identified articles were screened for eligibility using the web-based software Rayyan.ai. Eligible articles were identified, assessed, and categorized by the reviewers, either directly or through a combination of methods, using Atlas.ti version 9.1.7.0. Thereafter, data were charted accordingly and presented with the purpose of giving an overview of currently available literature while highlighting existing gaps. Results: A total of 101 eligible articles were included. This review found that most eHealth technologies (91/101, 90.1%) enable patients to self-monitor their symptoms using (smart) measuring devices (39/91, 43%), smartphones (27/91, 30%), or tablets (25/91, 27%). The self-management process of “taking ownership of health needs” (94/101, 93.1%), the behavior change technique of “feedback and monitoring” (88/101, 87%), and the positive health dimension of “bodily functioning” (101/101, 100%) were most often addressed. The inclusion criteria of studies and the actual populations reached show that a subset of people with COPD participate in eHealth studies. Conclusions: The current body of literature related to eHealth interventions has a strong tendency toward managing the physical aspect of COPD self-management. The necessity to specify inclusion criteria to control variables, combined with the practical challenges of recruiting diverse participants, leads to people with COPD being included in eHealth studies that only represent a subgroup of the whole population. Therefore, future research should be aware of this unintentional blind spot, make efforts to reach the underrepresented population, and address multiple dimensions of the positive health paradigm. %M 40063949 %R 10.2196/57649 %U https://www.jmir.org/2025/1/e57649 %U https://doi.org/10.2196/57649 %U http://www.ncbi.nlm.nih.gov/pubmed/40063949 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e55844 %T Effects of a Mobile Health Intervention Based on Behavioral Integrated Model on Cognitive and Behavioral Changes in Gestational Weight Management: Randomized Controlled Trial %A Zhou,Meng %A Wang,Li %A Deng,Ying %A Ge,Jinjin %A Zhao,Shiqi %A You,Hua %+ Department of Social Medicine and Health Education, School of Public Health, Nanjing Medical University, 101 Longmian Avenue, Jiangning District, Nanjing, 211166, China, 86 13382772548, youhua98@163.com %K cognition %K health behavior %K information-motivation-behavioral skills model %K mobile health %K psychological models %K pregnant woman %K randomized controlled trial %K mobile phone %D 2025 %7 10.3.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: The key to gestational weight management intervention involves health-related behaviors, including dietary and exercise management. Behavioral theory-based interventions are effective in improving health-related behaviors. However, evidence for mobile health interventions based on specific behavioral theories is insufficient and their effects have not been fully elucidated. Objective: This study aimed to examine the effects of a gestational mobile health intervention on psychological cognition and behavior for gestational weight management, using an integrated behavioral model as the theoretical framework. Methods: This study was conducted in a tertiary maternity hospital and conducted as a single-blind randomized controlled trial (RCT) in Changzhou, Jiangsu Province, China. Using the behavioral model, integrated with the protection motivation theory and information–motivation–behavioral skills model (PMT-IMB model), the intervention group received a mobile health intervention using a self-developed app from 14 to 37 gestational weeks, whereas the control group received routine guidance through the application. Psychological cognition and behaviors related to weight management during pregnancy were the main outcomes, which were measured at baseline, and at the second and third trimesters of pregnancy using a self-designed questionnaire. Generalized estimation and regression equations were used to compare the outcome differences between the intervention and control groups. Results: In total, 302 (302/360, 83.9%) participants underwent all measurements at 3 time points (intervention group: n=150; control group: n=152). Compared with the control group, the intervention group had significantly higher scores for information, perceived vulnerability, response cost, and exercise management in the second trimester, while their scores for perceived vulnerability, response cost, and diet management were significantly higher in the third trimester. The results of repeated measures analysis revealed that, in psychological cognition, the information dimension exhibited both the time effects (T3 β=3.235, 95% CI 2.859-3.611; P<.001) and the group effects (β=0.597, 95% CI 0.035-1.158; P=.04). Similarly, response costs demonstrated both the time effects (T3 β=0.745, 95% CI 0.199-1.291; P=.008) and the group effects (β=1.034, 95% CI 0.367-1.700; P=.002). In contrast, perceived vulnerability solely exhibited the group effects (β=0.669, 95% CI 0.050-1.288; P=.03). Regarding weight management behaviors, both time (T3 β=6, 95% CI 4.527-7.473; P<.001) and group (β=2.685, 95% CI 0.323-5.047; P=.03) had statistically significant impacts on the total points. Furthermore, the exercise management dimension also demonstrated both the time effects (T3 β=3.791, 95% CI 2.999-4.584; P<.001) and the group effects (β=1.501, 95% CI 0.232-2.771; P=.02). Conclusions: The intervention program was effective in increasing psychological cognitions in terms of information, perceived vulnerability, and response costs, as well as promoting healthy behaviors among Chinese pregnant women. This study provides new evidence supporting the effectiveness of mobile intervention based on behavioral science theory in gestational weight management. Trial Registration: Chinese Clinical Trial Registry ChiCTR2100043231; https://www.chictr.org.cn/showproj.html?proj=121736 %M 40063942 %R 10.2196/55844 %U https://www.jmir.org/2025/1/e55844 %U https://doi.org/10.2196/55844 %U http://www.ncbi.nlm.nih.gov/pubmed/40063942 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e60435 %T Generative AI–Enabled Therapy Support Tool for Improved Clinical Outcomes and Patient Engagement in Group Therapy: Real-World Observational Study %A Habicht,Johanna %A Dina,Larisa-Maria %A McFadyen,Jessica %A Stylianou,Mona %A Harper,Ross %A Hauser,Tobias U %A Rollwage,Max %+ Limbic Ltd, Kemp House, 128 City Road, London, EC1V 2NX, United Kingdom, 44 020 3818 3240, max@limbic.ai %K artificial intelligence %K National Health Service %K NHS Talking Therapies %K mental health %K therapy support tool %K cognitive behavioral therapy %K CBT %K chatbot %K conversational agent %K clinical %K patient engagement %K therapist %K treatment %K medication %K depression %K anxiety disorder %K exercise %K observational study %K control group %K patient adherence %D 2025 %7 10.3.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Cognitive behavioral therapy (CBT) is a highly effective treatment for depression and anxiety disorders. Nonetheless, a substantial proportion of patients do not respond to treatment. The lack of engagement with therapeutic materials and exercises between sessions, a necessary component of CBT, is a key determinant of unsuccessful treatment. Objective: The objective of this study was to test whether the deployment of a generative artificial intelligence (AI)–enabled therapy support tool, which helps patients to engage with therapeutic materials and exercises in between sessions, leads to improved treatment success and patient treatment adherence compared with the standard delivery of CBT exercises through static workbooks. Methods: We conducted a real-world observational study of 244 patients receiving group-based CBT in 5 of the United Kingdom’s National Health Service Talking Therapies services, comparing 150 (61.5%) patients who used the AI-enabled therapy support tool to 94 (38.5%) patients who used the standard delivery of CBT exercises. The groups were equivalent with respect to the content of the CBT materials and the human-led therapy sessions; however, the intervention group received support from the AI-enabled therapy support tool in conducting CBT exercises. Results: Patients using the AI-enabled therapy support tool exhibited greater attendance at therapy sessions and fewer dropouts from treatment. Furthermore, these patients demonstrated higher reliable improvement, recovery, and reliable recovery rates when compared to the control group, which was related to the degree of use of the AI-enabled therapy support tool. Moreover, we found that engagement with AI-supported CBT interventions, relative to psychoeducational materials, predicted better treatment adherence and treatment success, highlighting the role of personalization in the intervention’s effectiveness. To investigate the mechanisms of these effects further, we conducted a separate qualitative experiment in a nonclinical sample of users (n=113). Results indicated that users perceived the AI-enabled therapy support tool as most useful for discussing their problems to gain awareness and clarity of their situation as well as learning how to apply coping skills and CBT techniques in their daily lives. Conclusions: Our results show that an AI-enabled, personalized therapy support tool in combination with human-led group therapy is a promising avenue to improve the efficacy of and adherence to mental health care. %M 40063074 %R 10.2196/60435 %U https://www.jmir.org/2025/1/e60435 %U https://doi.org/10.2196/60435 %U http://www.ncbi.nlm.nih.gov/pubmed/40063074 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e60102 %T Optimizing Engagement With a Smartphone App to Prevent Violence Against Adolescents: Results From a Cluster Randomized Factorial Trial in Tanzania %A Janowski,Roselinde %A Cluver,Lucie D %A Shenderovich,Yulia %A Wamoyi,Joyce %A Wambura,Mwita %A Stern,David %A Clements,Lily %A Melendez-Torres,G J %A Baerecke,Lauren %A Ornellas,Abigail %A Chetty,Angelique Nicole %A Klapwijk,Jonathan %A Christine,Laetitia %A Mukabana,Ateamate %A Te Winkel,Esmee %A Booij,Anna %A Mbosoli,Gervas %A Lachman,Jamie M %+ Department of Social Policy and Intervention, University of Oxford, Barnett House, 32-37 Wellington Square, Oxford, OX1 2ER, United Kingdom, 44 01865270325, roselinde.janowski@spi.ox.ac.uk %K digital health %K engagement %K parenting %K adolescents %K low- and middle-income country %K violence against children %K Multiphase Optimization Strategy %K randomized factorial experiment %K mobile phone %D 2025 %7 10.3.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Violence and abuse exert extensive health, social, and economic burdens on adolescents in low- and middle-income countries. Digital parenting interventions are promising for mitigating risks at scale. However, their potential for public health impact hinges on meaningful engagement with the digital platform. Objective: The objective of this study was to evaluate the impact of 3 intervention design and implementation factors aimed at increasing engagement with a noncommercialized, offline-first smartphone app for caregivers of adolescents in Tanzania, in partnership with the United Nations Children’s Fund, the World Health Organization, and the Tanzanian national government. Methods: Following Multiphase Optimization Strategy (MOST) principles, we conducted a 2×2×2 cluster randomized factorial trial involving caregivers of adolescents aged 10 to 17 years. Caregivers were recruited by community representatives from 16 urban and periurban communities (ie, clusters) in the Mwanza region of Tanzania. Each cluster was randomized to 1 of 2 levels of each factor: guidance (self-guided or guided via facilitator-moderated WhatsApp groups), app design (structured or unstructured), and preprogram digital support (basic or enhanced). Primary outcomes were automatically tracked measures of engagement (app launches, modules completed, and home practice activities reviewed), with secondary outcomes including modules started, time spent in the app, and positive behaviors logged. Generalized linear mixed-effects models assessed the impact of experimental factors on engagement. Results: Automatically tracked engagement data from 614 caregivers were analyzed, of which 205 (33.4%) were men. Compared to self-guided participants, receiving guidance alongside the app led to significantly more app launches (mean ratio [MR] 2.93, 95% CI 1.84-4.68; P<.001), modules completed (MR 1.29, 95% CI 1.05-1.58; P=.02), modules started (MR 1.20, 95% CI 1.02-1.42; P=.03), time spent in the app (MR 1.45, 95% CI 1.39-1.51; P<.001), and positive behavior logs (MR 2.73, 95% CI 2.07-3.60; P<.001). Compared to the structured design, unstructured design use resulted in significantly more modules completed (MR 1.49, 95% CI 1.26-1.76; P<.001), home practice activity reviews (MR 7.49, 95% CI 5.19-10.82; P<.001), modules started (MR 1.27, 95% CI 1.06-1.52; P=.01), time spent in the app (MR 1.84, 95% CI 1.70-1.99; P<.001), and positive behavior logs (MR 55.68, 95% CI 16.48-188.14; P<.001). While analyses did not detect an effect of enhanced digital support on directly observed engagement, the combination of enhanced digital support and guidance positively influenced engagement across a range of outcomes. Conclusions: This study is the first to systematically optimize engagement with a digital parenting intervention in a low- and middle-income country. Our findings offer important learnings for developing evidence-based, scalable digital interventions in resource-constrained settings. Trial Registration: Pan-African Clinical Trial Registry PACTR202210657553944; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=24051 International Registered Report Identifier (IRRID): RR2-10.1186/s12889-023-15989-x %M 40063069 %R 10.2196/60102 %U https://www.jmir.org/2025/1/e60102 %U https://doi.org/10.2196/60102 %U http://www.ncbi.nlm.nih.gov/pubmed/40063069 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e59913 %T Using the Community Resilience Model and Project ECHO to Build Resiliency in Direct Support Professionals: Protocol for a Longitudinal Survey %A Lenker,Kristina Puzino %A Felix,Laura L %A Cichy,Sarah %A Lehman,Erik %A Logan,Jeanne M %A Murray,Michael %A Kraschnewski,Jennifer L %+ , Department of Internal Medicine, Penn State College of Medicine, 500 University Drive, Hershey, PA, 17033, United States, 1 7175310003, lfelix1@pennstatehealth.psu.edu %K neurodiversity %K community resilience model %K Project ECHO %K direct support professionals %K autism %K telementoring %K methods and feasibility %K resiliency %K intellectual disabilities %K ASD %K autism spectrum disorder %K DSP %K supportive care %K community resilience %K burnout %K resilience %K neurodivergent client %K neurodevelopmental disorders %K evidence-based knowledge %D 2025 %7 6.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Individuals with intellectual disabilities or autism spectrum disorder (ID/A) sometimes require supportive services from direct support professionals (DSPs). The supportive care provided to individuals with ID/A by DSPs can vary from assistance with daily living activities to navigating society. The COVID-19 pandemic not only exacerbated poor outcomes for individuals with ID/A but also for DSPs, who report experiencing burnout in the aftermath of the pandemic. DSPs are critical to providing much-needed support to individuals with ID/A. Objective: The goal of this study is to evaluate the impact of the community resilience model on DSP burnout and neurodivergent client outcomes using the Project ECHO (Extension for Community Healthcare Outcomes) telementoring platform as a dissemination tool. Methods: This protocol leverages community resilience theory and telementoring through the Project ECHO model to foster resilience in DSPs and their neurodiverse client population. ECHO participants’ resilience behaviors will be evaluated via surveys including the Connor Davison Resilience Scale and the WHO-5 Well-Being Index. These surveys will be administered preprogram, at the end of the 8-week ECHO program, and 90 days after the ECHO program’s completion. Pre-post relationships will be assessed using generalized estimating equations. The main outcomes will be self-reported changes in knowledge, self-efficacy, and resilience. Results: All ECHO program cohorts and follow-up data collection have concluded, with 131 survey participants. The project team is currently analyzing and interpreting the data. We anticipate having all data analyzed and interpreted by February 2025. Conclusions: DSPs provide critical services to individuals with ID/A. By providing skills in resiliency via the ECHO model, participants will be able to apply resiliency to their own professional lives while fostering resilience within their neurodiverse client base, leading to increased positive outcomes for both groups. International Registered Report Identifier (IRRID): DERR1-10.2196/59913 %M 40053792 %R 10.2196/59913 %U https://www.researchprotocols.org/2025/1/e59913 %U https://doi.org/10.2196/59913 %U http://www.ncbi.nlm.nih.gov/pubmed/40053792 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e58867 %T Patient Adoption of Digital Use Cases in Family Medicine and a Nuanced Implementation Approach for Family Doctors: Quantitative Web-Based Survey Study %A Beerbaum,Julian %A Robens,Sibylle %A Fehring,Leonard %A Mortsiefer,Achim %A Meister,Sven %+ Health Care Informatics, Faculty of Health, School of Medicine, Witten/Herdecke University, Pferdebachstr. 11, Witten, 58448, Germany, 49 230292678629, sven.meister@uni-wh.de %K technology acceptance %K UTAUT %K family doctor %K digital health %K eHealth %K video consultation %K electronic health records %K digital anamnesis %K online appointment scheduling %D 2025 %7 5.3.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital use cases describe the application of technology to achieve specific outcomes. Several studies in health care have examined patients’ overall attitudes toward digitalization and specific use cases. However, these studies have failed to provide a comparison of patient acceptance criteria between inherently different digital use cases in family medicine. Objective: To address this research gap, this paper aimed to assist family doctors in selecting digital use cases by comparing the underlying patient adoption factors and in driving usage of these use cases by presenting a differentiated implementation approach. Methods: Adapting an established Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire to 4 digital use cases in family medicine, we surveyed a large cross-sectional sample of adults living in Germany. The results of the web-based survey were then analyzed via descriptive statistics, ANOVA, and hierarchical regression models to compare the effects of sociodemographic and technology acceptance factors on the intention to use a specific use case. Results: Our web-based survey included 1880 participants. Of these 1880 participants, only 304 (16.2%) agreed that the degree of digitalization is important when selecting a family practice. However, more digitally literate participants attributed greater importance to this criterion (B=0.226, SE 0.023; β=.223; P<.001), and digital literacy was found to be dependent on age (Welch F3,968.29=53.441; P<.001). Regarding sociodemographic characteristics, only digital literacy demonstrated a significant effect on the intention to use for all use cases, particularly scheduling doctor appointments online (B=0.322, SE 0.033; β=.408; P<.001). Furthermore, performance expectancy was the strongest predictor of the intention to use for all use cases, while further effects of technology acceptance factors depended on the use case (receiving medical consultations via video: B=0.603, SE 0.049; β=.527; P<.001; scheduling doctor appointments online: B=0.566, SE 0.043; β=.513; P<.001; storing personal medical information via electronic health records: B=0.405, SE 0.047; β=.348; P<.001; and providing personal information before consultation digitally [digital anamnesis]: B=0.434, SE 0.048; β=.410; P<.001). To illustrate, perceived privacy and security had an effect on the intention to use electronic health records (B=0.284, SE 0.040; β=.243; P<.001) but no effect on the intention to use video consultations (B=0.068, SE 0.042; β=.053; P=.10). Conclusions: In the selection and implementation of digital use cases, family doctors should always prioritize the perceived value of the digital use case for the patient, and further criteria might depend on the digital use case. Practice owners should therefore always harmonize the introduction of digital use cases with their own patient care strategies. Not every digital innovation fits every strategy and therefore every practice. %M 40053731 %R 10.2196/58867 %U https://formative.jmir.org/2025/1/e58867 %U https://doi.org/10.2196/58867 %U http://www.ncbi.nlm.nih.gov/pubmed/40053731 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e67386 %T Internet-Based Cognitive Behavioral Therapy for Preventing Postpartum Depressive Symptoms Among Pregnant Individuals With Depression: Multicenter Randomized Controlled Trial in China %A Duan,Chen-Chi %A Zhang,Chen %A Xu,Hua-Lin %A Tao,Jing %A Yu,Jia-Le %A Zhang,Dan %A Wu,Shan %A Zeng,Xiu %A Zeng,Wan-Ting %A Zhang,Zhi-Yin %A Dennis,Cindy-Lee %A Liu,Han %A Wu,Jia-Ying %A Mol,Ben Willem J %A Huang,He-Feng %A Wu,Yan-Ting %+ Obstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan University, No.419, Fangxie Rd, Shanghai, 200000, China, 86 17321218018, yanting_wu@163.com %K antenatal depression %K postpartum depression %K internet-based cognitive behavioral therapy %K randomized controlled trial %D 2025 %7 4.3.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Women are particularly vulnerable to depression during pregnancy, which is one of the strongest risk factors for developing postpartum depression (PPD). Addressing antenatal depressive symptoms in these women is crucial for preventing PPD. However, little is known about the effectiveness of internet-based cognitive behavioral therapy (ICBT) in preventing PPD in this high-risk group. Objective: This study aims to evaluate the short- and long-term effects of ICBT in preventing PPD among women with antenatal depressive symptoms. Methods: Participants were screened for antenatal depressive symptoms using the Edinburgh Postnatal Depression Scale (EPDS) and randomly allocated (1:1) to either the ICBT group (receiving weekly online modules starting antenatally and continuing into early postpartum) or the control group (observed without treatment). Follow-up assessments were conducted up to 12 months postpartum, and data were analyzed using generalized estimating equations. The primary outcome was the prevalence of depressive symptoms at 6 weeks postpartum. A subgroup analysis based on the severity of antenatal depressive symptoms was also performed. The secondary outcomes included the long-term effects of ICBT on maternal depression, as well as its impact on anxiety, sleep quality, social support, parenting stress, co-parenting relationships, and infant development. Results: Between August 2020 and September 2021, 300 pregnant individuals were recruited from 5 centers across China. No significant differences were observed in depressive symptoms at 6 weeks postpartum (P=.18) or at any longer-term follow-up time points (P=.18). However, a post hoc subgroup analysis showed that participants with antenatal EPDS scores of 10-12 in the ICBT group had a lower risk of developing depression during the first year postpartum (odds ratio 0.534, 95% CI 0.313-0.912; P=.02), but this was not observed for participants with more severe depression. Additionally, this subgroup demonstrated higher levels of co-parenting relationships (P=.02). Conclusions: Among individuals with antenatal depression, ICBT did not prevent the development of PPD. However, ICBT may be a preferable option for those with mild to moderate antenatal depressive symptoms. Future research is needed to explore modifications to ICBT to address more severe depressive symptoms. Trial Registration: Chinese Clinical Trial Registry ChiCTR2000033433; https://www.chictr.org.cn/showproj.html?proj=54482 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-022-06728-5 %M 40053801 %R 10.2196/67386 %U https://www.jmir.org/2025/1/e67386 %U https://doi.org/10.2196/67386 %U http://www.ncbi.nlm.nih.gov/pubmed/40053801 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 8 %N %P e49507 %T Implementation of a Web-Based Program for Advance Care Planning and Evaluation of its Complexity With the Nonadoption, Abandonment, Scale-Up, Spread, And Sustainability (NASSS) Framework: Qualitative Evaluation Study %A van der Smissen,Doris %A Schreijer,Maud A %A van Gemert-Pijnen,Lisette J E W C %A Verdaasdonk,Rudolf M %A van der Heide,Agnes %A Korfage,Ida J %A Rietjens,Judith A C %+ Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Dr. Molewaterplein 40, Rotterdam, 3015 GD, The Netherlands, 31 107038460, i.korfage@erasmusmc.nl %K eHealth %K web-based intervention %K implementation %K sustainability %K advance care planning %K NASSS framework %K nonadoption, abandonment, scale-up, spread, and sustainability framework %K health communication %K patient education %K patient-centered care %D 2025 %7 4.3.2025 %9 Original Paper %J JMIR Aging %G English %X Background: The implementation of eHealth applications often fails. The NASSS (nonadoption, abandonment, scale-up, spread, and sustainability) framework aims to identify complexities in eHealth applications; the more complex, the more risk of implementation failure. Objective: This study aimed to analyze the implementation of the web-based advance care planning (ACP) program “Explore Your Preferences for Treatment and Care” using the NASSS framework. Methods: The NASSS framework enables a systematic approach to improve the implementation of eHealth tools. It is aimed at generating a rich and situated analysis of complexities in multiple domains, based on thematic analysis of existing and newly collected data. It also aims at supporting individuals and organizations to handle these complexities. We used 6 of 7 domains of the NASSS framework (ie, condition, technology, value proposition, adopters, external context, and embedding and adaptation over time) leaving out “organization,” and analyzed the multimodal dataset of a web-based ACP program, its development and evaluation, including peer-reviewed publications, notes of stakeholder group meetings, and interviews with stakeholders. Results: This study showed that the web-based ACP program uses straightforward technology, is embedded in a well-established web-based health platform, and in general appears to generate a positive value for stakeholders. A complexity is the rather broad target population of the program. A potential complexity considers the limited insight into the extent to which health care professionals adopt the program. Awareness of the relevance of the web-based ACP program may still be improved among target populations of ACP and among health care professionals. Furthermore, the program may especially appeal to those who value individual autonomy, self-management, and an explicit and direct communicative approach. Conclusions: Relatively few complexities were identified considering the implementation of the web-based ACP program “Explore Your Preferences for Treatment and Care.” The program is evidence-based, freestanding, and well-maintained, with straightforward, well-understood technology. The program is expected to generate a positive value for different stakeholders. Complexities include the broad target population of the program and sociocultural factors. People with limited digital literacy may need support to use the program. Its uptake might be improved by increasing awareness of ACP and the program among a wider population of potential users and among health care professionals. Addressing these issues may guide future use and sustainability of the program. %M 40053753 %R 10.2196/49507 %U https://aging.jmir.org/2025/1/e49507 %U https://doi.org/10.2196/49507 %U http://www.ncbi.nlm.nih.gov/pubmed/40053753 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e55592 %T Utilization and Experiences of Using Quit Now, a Nicotine and Tobacco Smoking Cessation Website: Thematic Analysis %A Salaheddin,Tala %A Sharma,Ramona H %A Fajardo,Marcela %A Panter,Cameron %A De Souza,Lauren %A Matano,Sheila Kanyevu %A Struik,Laura %+ Doctor of Medicine Program, Faculty of Medicine, University of British Columbia, 2329 West Mall, Vancouver, BC, V6T 1Z4, Canada, 1 6048222211, talasala@student.ubc.ca %K smoking cessation %K user experiences %K nicotine %K vaping %K web-based %K Google Analytics %K thematic analysis %K digital health %K nicotine replacement therapy %K quit attempts %K tobacco %K British Columbia %K behavioral support %K pharmacotherapy %K qualitative interview %K cessation support %K QuitNow %K mobile health %K mHealth %K intervention %D 2025 %7 4.3.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: British Columbia residents have access to a program called QuitNow that provides behavioral support and information about pharmacotherapy to nicotine and tobacco users. Web- or computer-based smoking cessation programs have been shown to yield an abstinence rate about 1.5 times higher when compared to a control. Although quantitative evidence reveals significant promise for web-based services like QuitNow, there is very little qualitative evidence available. Understanding website utilization and the experiences of end users is key to contextualizing the effectiveness of web-based cessation services and providing directions for enhancing these services. Objective: This qualitative interview study aims to delve into users’ utilization and experiences of QuitNow, which is supplemented by Google Analytics data. Methods: We interviewed 10 QuitNow users using semistructured interviews to understand what they liked the most and the least about QuitNow. We transcribed these interviews and conducted an inductive thematic analysis using NVivo (QSR International) software to extract common themes about user experiences. We also gathered utilization metrics via Google Analytics (n=13,856 users) to understand which aspects of QuitNow were used the most and which were used the least during the study period. Results: Thematic analysis yielded four major themes: (1) barriers to information access reduce opportunities to take action, (2) lack of clarity around pharmacological options is discouraging, (3) hearing from others is an important part of the journey, and (4) recognizing own agency throughout the quit process. These themes provided context and support for the Google Analytics data, which showed that end user activity, measured by indicators such as page views and average time spent on each page, was highest on pages about how to quit (10,393 page views), pharmacology information (1999 page views), and the community forum (11,560 page views). Conclusions: Results of this study point to several important implications for improving the website, as well as directions for enhancing cessation support services in general. %M 40053769 %R 10.2196/55592 %U https://www.jmir.org/2025/1/e55592 %U https://doi.org/10.2196/55592 %U http://www.ncbi.nlm.nih.gov/pubmed/40053769 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e63110 %T Evidence on Digital HIV Self-Testing From Accuracy to Impact: Updated Systematic Review %A Beecroft,Ashlyn %A Vaikla,Olivia %A Engel,Nora %A Duchaine,Thomas %A Liang,Chen %A Pant Pai,Nitika %+ Research Institute of the McGill University Health Centre, 5252 boul de Maisonneuve W., Montreal, QC, H4A 3S5, Canada, 1 514 934 1934 ext 44729, nitika.pai@mcgill.ca %K digital HIV self-testing %K impact %K linkage %K outcomes %K HIV %K HIV infection %K HIV self-testing %K self-testing %K digital innovation %K systematic review %K accuracy %K patient-centered %K middle- to high-income countries %K digital health %K mHealth %K health education %K sexually transmitted diseases %K sexual behavior %D 2025 %7 4.3.2025 %9 Review %J J Med Internet Res %G English %X Background: HIV self-testing has gained momentum following the approval of self-testing methods and novel technological advancements. Digital HIV self-testing involves completing an oral or blood-based HIV self-test with support from a digital innovation. Objective: We conducted a systematic review on the existing data analyzing digital HIV self-testing accuracy while updating research on digital HIV self-test acceptability, preference, feasibility, and impact. Methods: We searched Embase and PubMed for records on HIV self-testing with digital support. Included studies significantly incorporated a form of digital innovation throughout the HIV self-test process and reported quantitative data. For accuracy measures, the search spanned January 1, 2013, to October 15, 2024; for patient-centered and impact outcomes, we updated existing literature (June 16, 2021, to October 15, 2024) reported in a previous systematic review. Studies’ quality was assessed using the QUADAS 2 Tool, Newcastle-Ottawa Scale, and Cochrane Risk of Bias Tool 2. Results: Fifty-five studies (samples ranging 120-21,035, median 1267 participants) were summarized from 19 middle- to high-income countries. Seven studies reported on the accuracy of HIV self-testing with innovations from >5000 participants. Diagnostic performance metrics, including point estimates of specificity, sensitivity, positive predictive value, and negative predictive value were measured (n=3), and ranged from: 96.8% to 99.9%, 92.9% to 100.0%, 76.5% to 99.2%, and 99.2% to 100.0%, respectively. The percentage of invalid test results for oral and blood-based self-tests ranged from 0.2% to 12.7% (n=4). Fifty-one studies reported data on metrics beyond accuracy, including acceptability, preference, feasibility, and impact outcomes from >30,000 participants. Majority (38/51, 74.5%) were observational studies, while 25.5% (13/51) reported data from randomized controlled trials. Acceptability and preference outcomes varied from 64.5% to 99.0% (14/51) and 4.6% to 99.3% (8/51), respectively. Feasibility outcomes included test uptake (30.9% to 98.2%; 28/51), response rate (26.0% to 94.8%; 7/51), and visits to web-based providers (43.0% to 70.7%; n=4). Impact outcomes assessed new infections (0.0% to 25.8%; 31/51), first-time testers (2.0% to 53.0%; 26/51), result return proportions (22.1% to 100.0%; 24/51), linkage to care as both connections to confirmatory testing and counseling (53.0% to 100.0%; 16/51), and referrals for treatment initiation (44.4% to 98.1%; 8/51). The quality of studies varied, though they generally demonstrated low risk of bias. Conclusions: Digital innovations improved the accuracy of HIV self-test results, and were well-accepted and preferred by participants. Operationally, they were found to be feasible and reported impacting the HIV self-testing process. These findings are in favor of the use of digital HIV self-test innovations as a promising support tool and suggest that digital HIV self-tests’ service delivery models hold promise in not only facilitating HIV testing but also impacting operational outcomes that are crucial to reaching Joint United Nations Program on HIV/AIDS targets in middle- to high-income countries. Trial Registration: PROSPERO CRD42020205025; https://www.crd.york.ac.uk/prospero/CRD42020205025 %M 40053740 %R 10.2196/63110 %U https://www.jmir.org/2025/1/e63110 %U https://doi.org/10.2196/63110 %U http://www.ncbi.nlm.nih.gov/pubmed/40053740 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e48370 %T Development and Testing of the Kids Hurt App, a Web-Based, Pain Self-Report App for First Nations Youths: Mixed Methods Study %A Francis,Karlee %A Francis,Julie %A Latimer,Margot %A Gould,Hayley %A Blackmore,Shante %A MacLeod,Emily %K app %K eHealth %K pain %K Indigenous %K First Nations %K children %K youths %K mobile phone %D 2025 %7 3.3.2025 %9 %J JMIR Hum Factors %G English %X Background: First Nations children and youths may have unique ways to convey their health needs that have not been recognized by health providers. This may contribute to the disparity between high rates of mental health and physical pain and low rates of treatment for the conditions they experience. Evidence suggests that a colonial history has resulted in poor experiences with the health care system, lack of trust with health providers, and miscommunication between clinicians and patients. Contemporary ways, using both Indigenous and Western knowledge, are needed to bridge the gap in communicating pain. Objective: The aim of this qualitative study was to test the usability and clinical feasibility of the Kids Hurt App with First Nations youths and clinicians working with youths. Methods: Using a Two-Eyed Seeing approach, the Kids Hurt App was developed using concepts from validated mood and pain assessment apps combined with community-based research that gathered First Nations youths and clinicians perspectives on quality, intensity, and location of pain and hurt. The Kids Hurt App contains 16 screens accessible on any web-based device. Results: In total, 3 rounds of low-fidelity testing (n=19), 2 rounds of high-fidelity testing (n=20), and 2 rounds of clinical feasibility testing (n=10) were conducted with First Nations youths (10‐19 years) to determine the relevance, validity, and usability of the Kids Hurt App. High-fidelity testing was also conducted with 15 clinicians after completing the high-fidelity youth sessions. Youths had constructive suggestions that were used to improve the app in subsequent rounds of version testing. There was one main discrepancy between youths and clinicians related to preference for how best to visually convey pain. The youth’s preference was maintained in the app. Conclusions: All youths in all rounds of testing indicated that they would use the Kids Hurt App if it was available to them in a health care setting, with most clinicians noting that the app would be useful in practice. %R 10.2196/48370 %U https://humanfactors.jmir.org/2025/1/e48370 %U https://doi.org/10.2196/48370 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 8 %N %P e64661 %T Identifying Food Preferences and Malnutrition in Older Adults in Care Homes: Co-Design Study of a Digital Nutrition Assessment Tool %A Connelly,Jenni %A Swingler,Kevin %A Rodriguez-Sanchez,Nidia %A Whittaker,Anna C %+ Faculty of Health Sciences and Sport, University of Stirling, 3a74a Cottrell Building, Stirling, FK9 4LA, United Kingdom, 44 1786 466399, jenni.connelly1@stir.ac.uk %K ageing %K digital technology %K dietary measurement %K care homes %K co-design %K dietary intake %K food diary %D 2025 %7 3.3.2025 %9 Original Paper %J JMIR Aging %G English %X Background: Malnutrition is a challenge among older adults and can result in serious health consequences. However, the dietary intake monitoring needed to identify malnutrition for early intervention is affected by issues such as difficulty remembering or needing a dietitian to interpret the results. Objective: This study aims to co-design a tool using automated food classification to monitor dietary intake and food preferences, as well as food-related symptoms and mood and hunger ratings, for use in care homes. Methods: Participants were 2 separate advisory groups and 2 separate sets of prototype testers. The testers for the first prototype were 10 community-dwelling older adults based in the Stirlingshire area in Scotland who noted their feedback on the tool over 2 weeks in a food diary. The second set of testers consisted of 14 individuals (staff: n=8, 57%; and residents: n=6, 43%) based in 4 care homes in Scotland who provided feedback via interview after testing the tool for a minimum of 3 days. In addition, 130 care home staff across the United Kingdom completed the web-based survey on the tool’s needs and potential routes to pay for it; 2 care home managers took part in follow-up interviews. Data were collected through food diaries, a web-based survey, audio recordings and transcriptions of focus groups and interviews, and research notes. Systematic text condensation was used to describe themes across the different types of data. Results: Key features identified included ratings of hunger, mood, and gastrointestinal symptoms that could be associated with eating specific foods, as well as a traffic light system to indicate risk. Issues included staff time, Wi-Fi connectivity, and the accurate recognition of pureed food and fortified meals. Different models for potential use and commercialization were identified, including peer support among residents to assist those considered less able, staff-only use of the tool, care home–personalized database menus for easy meal photo selection, and targeted monitoring of residents considered to be at the highest risk using the traffic light system. Conclusions: The tool was deemed useful for monitoring dietary habits and associated symptoms, but necessary design improvements were identified. These should be incorporated before formal evaluation of the tool as an intervention in this setting. Co-design was vital to help make the tool fit for the intended setting and users. %M 40053797 %R 10.2196/64661 %U https://aging.jmir.org/2025/1/e64661 %U https://doi.org/10.2196/64661 %U http://www.ncbi.nlm.nih.gov/pubmed/40053797 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e58262 %T A Digital Program for Daily Life Management With Endometriosis: Pilot Cohort Study on Symptoms and Quality of Life Among Participants %A Breton,Zélia %A Stern,Emilie %A Pinault,Mathilde %A Lhuillery,Delphine %A Petit,Erick %A Panel,Pierre %A Alexaline,Maïa %+ Lyv Healthcare, 6 rue Edouard Nignon, Nantes, 44300, France, 33 650208680, maia@lyv.app %K digital program %K endometriosis %K integrative therapies %K quality of life %K nonpharmacological intervention %K daily life %K adenomyosis %K lesions %K women %K digital %K France %K case control %K digital health %K pilot study %K control group %K global symptom %K burden %K depression %K neuropathic pain %K chronic %K multidisciplinary %K web based %K mobile health %K mHealth %K intervention %D 2025 %7 28.2.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: After experiencing symptoms for an average of 7 years before diagnosis, patients with endometriosis are usually left with more questions than answers about managing their symptoms in the absence of a cure. To help women with endometriosis after their diagnosis, we developed a digital program combining user research, evidence-based medicine, and clinical expertise. Structured around cognitive behavioral therapy and the quality of life metrics from the Endometriosis Health Profile score, the program was designed to guide participants for 3 months. Objective: This cohort study was designed to measure the impact of a digital health program on the symptoms and quality of life levels of women with endometriosis. Methods: In total, 63% (92/146) of the participants were included in the pilot study, recruited either free of charge through employer health insurance or via individual direct access. A control group of 404 women with endometriosis who did not follow the program, recruited through social media and mailing campaigns, was sampled (n=149, 36.9%) according to initial pain levels to ensure a similar pain profile to participants. Questionnaires assessing quality of life and symptom levels were emailed to both groups at baseline and 3 months. Descriptive statistics and statistical tests were used to analyze intragroup and intergroup differences, with Cohen d measuring effect sizes for significant results. Results: Over 3 months, participants showed substantial improvements in global symptom burden, general pain level, anxiety, depression, dysmenorrhea, dysuria, chronic fatigue, neuropathic pain, and endo belly. These improvements were significantly different from the control group for global symptom burden (participants: mean –0.7, SD 1.6; controls: mean –0.3, SD 1.3; P=.048; small effect size), anxiety (participants: mean –1.1, SD 2.8; controls: mean 0.2, SD 2.5; P<.001; medium effect size), depression (participants: mean –0.9, SD 2.5; controls: mean 0.0, SD 3.1; P=.04; small effect size), neuropathic pain (participants: mean –1.0, SD 2.7; controls: mean –0.1, SD 2.6; P=.004; small effect size), and endo belly (participants: mean –0.9, SD 2.5; controls: mean –0.3, SD 2.4; P=.03; small effect size). Participants’ quality of life improved between baseline and 3 months and significantly differed from that of the control group for the core part of the Endometriosis Health Profile-5 (participants: mean –5.9, SD 21.0; controls: mean 1.0, SD 14.8; P=.03; small effect size) and the EQ-5D (participants: mean 0.1, SD 0.1; controls: mean –0.0, SD 0.1; P=.001; medium effect size). Perceived knowledge of endometriosis was significantly greater at 3 months among participants compared to the control group (P<.001). Conclusions: This study’s results suggest that a digital health program providing medical and scientific information about endometriosis and multidisciplinary self-management tools may be useful to reduce global symptom burden, anxiety, depression, neuropathic pain, and endo belly while improving knowledge on endometriosis and quality of life among participants. %M 39791286 %R 10.2196/58262 %U https://formative.jmir.org/2025/1/e58262 %U https://doi.org/10.2196/58262 %U http://www.ncbi.nlm.nih.gov/pubmed/39791286 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e55603 %T Evaluation of the Clear Fear Smartphone App for Young People Experiencing Anxiety: Uncontrolled Pre– and Post–Follow-Up Study %A Samele,Chiara %A Urquia,Norman %A Edwards,Rachel %A Donnell,Katie %A Krause,Nihara %+ , stem4, Connect House, 133-137 Alexandra Road, Wimbledon, London, SW19 7JY, United Kingdom, 44 7956396375, dr.nihara.krause@stem4.org.uk %K mental health %K anxiety %K depression %K emotional and behavioral difficulties %K mobile phone app %K cognitive behavioral therapy %K digital tool %K young people %K mobile phone %D 2025 %7 28.2.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Mobile health apps are proving to be an important tool for increasing access to psychological therapies early on, particularly with rising rates of anxiety and depression in young people. Objective: We aimed to assess the usability, acceptability, safety, and effectiveness of a new app, Clear Fear, developed to help young people manage symptoms of anxiety using the principles of cognitive behavioral therapy. Methods: The Clear Fear app was developed to provide cognitive behavioral strategies to suit anxiety disorders. An uncontrolled pre– and post–follow-up design over a 9-week period was used to assess the app and its effects. This study comprised 3 phases: baseline (stage 1), post–app familiarization phase (stage 2), and follow-up (stage 3). Eligible participants were aged between 16 and 25 years with mild to moderate anxiety but not currently receiving treatment or in contact with specialist mental health services or using other interventions or apps to help monitor or manage their mental health. A community sample was recruited via advertisements, relevant websites, and social media networks. Eligible participants completed standardized self-report tools and questionnaires at each study stage. These measured probable symptoms of anxiety (7-item Generalized Anxiety Disorder scale) and depression (Mood and Feelings Questionnaire); emotional and behavioral difficulties (Strengths and Difficulties Questionnaire); and feedback on the usability, accessibility, and safety of the app. Mean scores at baseline and follow-up were compared using paired 2-tailed t tests or Wilcoxon signed rank tests. Qualitative data derived from open-ended questions were coded and entered into NVivo (version 10) for analysis. Results: A total of 48 young people entered the study at baseline, with 37 (77%) completing all outcome measures at follow-up. The sample was mostly female (37/48, 77%). The mean age was 20.1 (SD 2.1) years. In total, 48% (23/48) of the participants reached the threshold for probable anxiety disorder, 56% (27/48) had positive scores for probable depression, and 75% (36/48) obtained a total score of “very high” on the Strengths and Difficulties Questionnaire for emotional and behavioral difficulties. The app was well received, offering reassurance, practical and immediate help to manage symptoms, and encouragement to seek help, and was generally found easy to use. A small minority (3/48, 6%) found the app difficult to navigate. The Clear Fear app resulted in statistically significant reductions in probable symptoms of anxiety (t36=2.6, 95% CI 0.41-3.53; P=.01) and depression (z=2.3; P=.02) and behavioral and emotional difficulties (t47=4.5, 95% CI 3.67-9.65; P<.001), representing mostly medium to large standardized effect sizes. Conclusions: The Clear Fear app was found to be usable, acceptable, safe, and effective in helping manage symptoms of anxiety and depression and emotional and behavioral difficulties. %M 40053764 %R 10.2196/55603 %U https://formative.jmir.org/2025/1/e55603 %U https://doi.org/10.2196/55603 %U http://www.ncbi.nlm.nih.gov/pubmed/40053764 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e58341 %T Web-Based Application for Reducing Methamphetamine Use Among Aboriginal and Torres Strait Islander People: Randomized Waitlist Controlled Trial %A Reilly,Rachel %A McKetin,Rebecca %A Barzi,Federica %A Degan,Tayla %A Ezard,Nadine %A Conigrave,Katherine %A Butt,Julia %A Roe,Yvette %A Wand,Handan %A Quinn,Brendan %A Longbottom,Wade %A Treloar,Carla %A Dunlop,Adrian %A Ward,James %+ School of Psychology, University of Adelaide, North Terrace, Adelaide, 5005, Australia, 61 881284216, rachel.reilly@sahmri.com %K methamphetamine %K Aboriginal and Torres Strait Islander Health %K web-based intervention %K randomised controlled trial %K therapeutic program %K methamphetamine use %K substance use %K digital interventions %K treatment %K psychosocial wellbeing %K effectiveness %K app %K psychosocial distress %K mobile phone %D 2025 %7 28.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital interventions can help to overcome barriers to care, including stigma, geographical distance, and a lack of culturally appropriate treatment options. “We Can Do This” is a web-based app that was designed with input from cultural advisors and end users to support Aboriginal and Torres Strait Islander people seeking to stop or reduce their use of methamphetamine and increase psychosocial well-being. Objective: This study aimed to evaluate the effectiveness of the “We Can Do This” web-based app as a psychosocial treatment for Aboriginal and Torres Strait Islander people who use methamphetamine. Methods: The web app was evaluated using a randomized waitlist controlled parallel group trial. Participants were Aboriginal and Torres Strait Islander people aged 16 years or older who self-identified as having used methamphetamine at least weekly for the past 3 months. Participants were randomized on a 1:1 ratio to receive either access to the web-based app for 6 weeks or a waitlist control group. Both groups received access to a website with harm minimization information. The primary outcome was days of methamphetamine use in the past 4 weeks assessed at 1, 2, and 3 months post randomization. Secondary outcomes included severity of methamphetamine dependence (Severity of Dependence Scale [SDS]), psychological distress (Kessler 10 [K10]), help-seeking behavior, and days spent out of role due to methamphetamine use. Results: Participants (N=210) were randomized to receive either access to the web-based app (n=115) or the waitlist control condition (n=95). Follow-up was 63% at 1 month, 57% at 2 months, and 54% at 3 months. There were no significant group differences in days of methamphetamine use in the past 4 weeks at 1 the month (mean difference 0.2 days, 95% CI –1.5 to –2), 2 months (mean difference 0.6 days, 95% CI –1 to 2.4 days) or 3 months (mean difference 1.4 days, 95% CI –0.3 to 3.3 days) follow-up. There were no significant group differences in K10 scores, SDS scores, days out of role, or help-seeking at any of the 3 follow-up timepoints. There was poor adherence to the web-based app, only 20% of participants in the intervention group returned to the web-based app after their initial log-in. Participants cited personal issues and forgetting about the web-based app as the most common reasons for nonadherence. Conclusions: We found poor engagement with this web-based app. The web-based app had no significant effects on methamphetamine use or psychosocial well-being. Poor adherence and low follow-up hindered our ability to accurately evaluate the effectiveness of the web-based app. Future web-based apps for this population need to consider methods to increase participant engagement. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619000134123p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376088 International Registered Report Identifier (IRRID): RR2-10.2196/14084 %M 40053754 %R 10.2196/58341 %U https://www.jmir.org/2025/1/e58341 %U https://doi.org/10.2196/58341 %U http://www.ncbi.nlm.nih.gov/pubmed/40053754 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 12 %N %P e56066 %T A Narrative Review to Identify Promising Approaches for Digital Health Interventions to Support Emotion Regulation for Adolescents With Attention-Deficit/Hyperactivity Disorder %A Murray,Aja Louise %A Thye,Melissa %A Obsuth,Ingrid %A Cai,Shufang %A Lui,Michael %A Orr,Corina %A Saravanan,Anusha %+ Department of Psychology, University of Edinburgh, 7 George Square, Edinburgh, EH8 9JZ, United Kingdom, 44 0131 650 3455, aja.murray@ed.ac.uk %K attention-deficit/hyperactivity disorder %K ADHD %K digital health intervention %K adolescence %K emotion regulation %K emotion dysregulation %K mobile phone %K emotion %K teens %K youths %K narrative review %K support %K development %K design %K regulation %K young people %K evaluation %K neurodiversity %K neurodivergent %K attention deficit %K neurodiverse %K neuroscience %K mental health %K digital mental health %D 2025 %7 27.2.2025 %9 Viewpoint %J JMIR Ment Health %G English %X Emotion regulation difficulties affect many adolescents with attention-deficit/hyperactivity disorder (ADHD), and previous research has highlighted a need for accessible interventions to support them in this domain, especially in real-life contexts. Digital health interventions (DHIs) can be embedded in adolescents’ daily lives and thus offer considerable promise for meeting this need. However, there is a lack of information to guide the development of suitable emotion regulation DHIs for this population. The goal of this study is, therefore, to identify recommendations to guide the development of emotion regulation DHIs for adolescents with ADHD. This narrative review synthesizes diverse relevant evidence to inform their development, including promising therapeutic approaches and components and relevant design and development considerations. We find that there is very little direct evidence of “what works” for emotion regulation DHIs and emotion regulation interventions more generally for adolescents with ADHD; however, we identify promising therapeutic approaches for new DHIs. We also recommend following a co-design or coproduction approach with adolescents with ADHD, including exploring elements designed to motivate and engage young people to support sustained adherence. We conclude that DHIs are a promising approach for emotion regulation interventions for adolescents with ADHD, could draw on a range of existing therapeutic approaches, and should be co-designed with users themselves. %M 40053767 %R 10.2196/56066 %U https://mental.jmir.org/2025/1/e56066 %U https://doi.org/10.2196/56066 %U http://www.ncbi.nlm.nih.gov/pubmed/40053767 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e69602 %T Automated Digital Safety Planning Interventions for Young Adults: Qualitative Study Using Online Co-design Methods %A Meyerhoff,Jonah %A Popowski,Sarah A %A Lakhtakia,Tanvi %A Tack,Emily %A Kornfield,Rachel %A Kruzan,Kaylee P %A Krause,Charles J %A Nguyen,Theresa %A Rushton,Kevin %A Pisani,Anthony R %A Reddy,Madhu %A Van Orden,Kimberly A %A Mohr,David C %+ Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, 750 North Lake Shore Drive, Chicago, IL, 60611, United States, 1 3125031232, jonah.meyerhoff@northwestern.edu %K mental health services %K technology %K therapy %K computer assisted %K SMS text messaging %D 2025 %7 26.2.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Young adults in the United States are experiencing accelerating rates of suicidal thoughts and behaviors but have the lowest rates of formal mental health care. Digital suicide prevention interventions have the potential to increase access to suicide prevention care by circumventing attitudinal and structural barriers that prevent access to formal mental health care. These tools should be designed in collaboration with young adults who have lived experience of suicide-related thoughts and behaviors to optimize acceptability and use. Objective: This study aims to identify the needs, preferences, and features for an automated SMS text messaging–based safety planning service to support the self-management of suicide-related thoughts and behaviors among young adults. Methods: We enrolled 30 young adults (age 18-24 years) with recent suicide-related thoughts and behaviors to participate in asynchronous remote focus groups via an online private forum. Participants responded to researcher-posted prompts and were encouraged to reply to fellow participants—creating a threaded digital conversation. Researcher-posted prompts centered on participants’ experiences with suicide-related thought and behavior-related coping, safety planning, and technologies for suicide-related thought and behavior self-management. Focus group transcripts were analyzed using thematic analysis to extract key needs, preferences, and feature considerations for an automated SMS text messaging–based safety planning tool. Results: Young adult participants indicated that an automated digital SMS text message–based safety planning intervention must meet their needs in 2 ways. First, by empowering them to manage their symptoms on their own and support acquiring and using effective coping skills. Second, by leveraging young adults’ existing social connections. Young adult participants also shared 3 key technological needs of an automated intervention: (1) transparency about how the intervention functions, the kinds of actions it does and does not take, the limits of confidentiality, and the role of human oversight within the program; (2) strong privacy practices—data security around how content within the intervention and how private data created by the intervention would be maintained and used was extremely important to young adult participants given the sensitive nature of suicide-related data; and (3) usability, convenience, and accessibility were particularly important to participants—this includes having an approachable and engaging message tone, customizable message delivery options (eg, length, number, content focus), and straightforward menu navigation. Young adult participants also highlighted specific features that could support core coping skill acquisition (eg, self-tracking, coping skill idea generation, reminders). Conclusions: Engaging young adults in the design process of a digital suicide prevention tool revealed critical considerations that must be addressed if the tool is to effectively expand access to evidence-based care to reach young people at risk for suicide-related thoughts and behaviors. Specifically, automated digital safety planning interventions must support building skillfulness to cope effectively with suicidal crises, deepening interpersonal connections, system transparency, and data privacy. %M 40009840 %R 10.2196/69602 %U https://formative.jmir.org/2025/1/e69602 %U https://doi.org/10.2196/69602 %U http://www.ncbi.nlm.nih.gov/pubmed/40009840 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e59829 %T Formative Evaluation of Suicide Prevention Websites for Men: Qualitative Study with Men at Risk of Suicide and with Potential Gatekeepers %A Reifegerste,Doreen %A Wagner,Anna J M %A Huber,Lisa %A Fastuca,Manuel %+ School of Public Health, Bielefeld University, Universitaetsstrasse 25, Bielefeld, 33615, Germany, 49 521 10667 ext 807, doreen.reifegerste@uni-bielefeld.de %K mental health %K suicide prevention %K men’s health %K evaluation %K website %K gatekeeper %K suicide %K male %K suicide risk %K digital communication %K intervention %K suicidal behavior %K digital intervention %K digital media %D 2025 %7 26.2.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: The suicide rate among men exceeds that of women worldwide. One important measure in suicide prevention for men is digital communication interventions, as they enable easy and anonymous access to information resources. This is especially important for men who might not be reached by traditional, in-person prevention methods. Thus, as part of an interdisciplinary project on suicide prevention for men, two specific digital communication prevention measures were developed: (1) a website to inform men at risk about suicide prevention, and (2) a website to educate potential gatekeepers who are in contact with men at risk of suicide about appropriate life-saving measures. Both websites needed evaluation to explore how they are perceived by (1) men and by (2) potential gatekeepers of men at risk of suicide. This is crucial, as existing research lacks formative evaluation that informs the development of intervention communication materials. Objective: This study aimed to analyze whether these websites were perceived as (1) comprehensible and engaging, (2) authentic and trustworthy, as well as (3) useful by (potential) users. Furthermore, we examined (4) additional ideas for effective communication about suicide prevention. Methods: We conducted (1) individual videoconference interviews with 24 men to evaluate the website and (2) four focus groups with 8 gatekeepers in each group (32 participants) to evaluate the online education program. The focus group sample was equally distributed regarding gender and age. Recruitment was conducted together with a field research partner who posted adverts on Facebook and Instagram (Meta) to reach as many potential participants as possible in an efficient way. All participants were asked to evaluate the intervention materials using a fictitious scenario of a man experiencing a mental health crisis before the interviews or focus groups took place. Results: The videos were perceived as (1) catchy, comprehensible, and empathetic, but too long for a short introduction. A balanced mix of emotional and informative content was considered appropriate and helpful. The health information provided was perceived as (2) serious and trustworthy due to citing scientific institutions and video material of men who had experienced suicidal ideation. (3) The intervention’s applicability for men experiencing acute crisis was critiqued, but it was regarded as very useful for comprehensive information. (4) Further communication channels and addressing other male subgroups or gender identities were presented as possible extensions of the program. Conclusions: Effective suicide prevention research should address both the groups at risk and their support network. Digital communication interventions can provide low-threshold access. Videos with personalized examples are important to give men someone to identify with, which validates their emotional responses and supports their self-esteem, while videos with experts provide relevant and credible information. %M 40009838 %R 10.2196/59829 %U https://formative.jmir.org/2025/1/e59829 %U https://doi.org/10.2196/59829 %U http://www.ncbi.nlm.nih.gov/pubmed/40009838 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 8 %N %P e68957 %T Building Strong Foundations: Nonrandomized Interventional Study of a Novel, Digitally Delivered Fall Prevention Program for Older Adults %A Wing,David %A Nichols,Jeanne F %A Barkai,Hava Shoshana %A Culbert,Olivia %A Moreno,Daniel %A Higgins,Michael %A O'Brien,Anna %A Perez,Mariana %A Davey,Hope %A Moran,Ryan %+ , Exercise and Physical Activity Resource Center, University of California, San Diego, 9500 Gilman Drive #0811, CALIT2/Atkinson Hall Room 3504, San Diego, CA, 92093, United States, 1 858 534 9315, dwing@eng.ucsd.edu %K exercise %K older adults %K digital intervention %K Zoom %K balance %K posture %K strength %K fall prevention %D 2025 %7 26.2.2025 %9 Original Paper %J JMIR Aging %G English %X Background: Injuries from falls are a major concern among older adults. Targeted exercise has been shown to improve fall risk, and recommendations for identifying and referring older adults for exercise-based interventions exist. However, even when very inexpensive or free, many do not use available fall prevention programs, citing barriers related to convenience and safety. These issues are even greater among older adults residing in rural areas where facilities are less abundant. These realities highlight the need for different approaches to reducing falls in novel ways that increase reach and are safe and effective. Web-based delivery of exercise interventions offers some exciting and enticing prospects. Objective: Our objective was to assess the efficacy of the Strong Foundations exercise program to change markers of physical function, posture, balance, strength, and fall risk. Methods: Strong Foundations is a once weekly (60 minutes), 12-week iterative program with 3 core components: postural alignment and control, balance and mobility, and muscular strength and power. We used a quasi-experimental design to determine changes in physical function specific to balance, postural control, and muscular strength among older adults at low or moderate risk of falling. Results: A total of 55 low-risk and 37 moderate-risk participants were recruited. Participants significantly improved on the 30-second Chair Stand (mean change of 1, SD 3.3 repetitions; P=.006) and Timed Up and Go (mean change of 0.2, SD 0.7 seconds; P=.004), with the moderate-risk group generally improving to a greater degree than the low-risk group. Additionally, Short Physical Performance Battery performance improved significantly in the moderate-risk category (P=.02). The majority of postural measures showed statistically significant improvement for both groups (P<.05). Measures of “relaxed” posture showed improvements between 6% and 27%. When an “as tall as possible” posture was adopted, improvements were ~36%. Conclusions: In this 12-week, iterative, web-based program, we found older adults experienced improvement not only in measures used in clinical contexts, such as the 30-second Chair Stand and Timed Up and Go, but also contextualized gains by providing deeper phenotypical measurement related to posture, strength, and balance. Further, many of the physical improvements were attenuated by baseline fall risk level, with those with the highest level of risk having the greater gains, and, thus, the most benefit from such interventions. %M 40009847 %R 10.2196/68957 %U https://aging.jmir.org/2025/1/e68957 %U https://doi.org/10.2196/68957 %U http://www.ncbi.nlm.nih.gov/pubmed/40009847 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e58543 %T Features of Structured, One-to-One Videoconference Interventions That Actively Engage People in the Management of Their Chronic Conditions: Scoping Review %A Chen,Yu-Ting %A Lehman,Michelle %A Van Denend,Toni %A Kish,Jacqueline %A Wu,Yue %A Preissner,Katharine %A Plow,Matthew %A Packer,Tanya L %+ School of Health Administration, Faculty of Health, Dalhousie University, Sir Charles Tupper Medical Building, 2nd Floor, 5850 College St., PO Box 15000, Halifax, NS, B3H 4R2, Canada, 1 902 494 7097, tanya.packer@dal.ca %K videoconference %K chronic disease management %K active participation %K intervention program %K self-management %K scoping review %K Taxonomy of Every Day Self-Management Strategies %K TEDSS %K Behavior Change Technique Taxonomy version 1 %K BCTTv1 %K behavior change %K mobile phone %D 2025 %7 26.2.2025 %9 Review %J J Med Internet Res %G English %X Background: A dramatic increase in the use of videoconferencing occurred as a response to the COVID-19 pandemic, including delivery of chronic disease management programs. With this increase, clients’ openness to and confidence in receiving any type of telehealth care has dramatically improved. However, the rapidity of the response was accomplished with little time to learn from existing knowledge and research. Objective: The purpose of this scoping review was to identify features, barriers, and facilitators of synchronous videoconference interventions that actively engage clients in the management of chronic conditions. Methods: Using scoping review methodology, MEDLINE, CINAHL, and 6 other databases were searched from 2003 onward. The included studies reported on structured, one-on-one, synchronous videoconferencing interventions that actively engaged adults in the management of their chronic conditions at home. Studies reporting assessment or routine care were excluded. Extracted text data were analyzed using thematic analysis and published taxonomies. Results: The 33 included articles reported on 25 distinct programs. Most programs targeted people with neurological conditions (10/25, 40%) or cancer (7/25, 28%). Analysis using the Taxonomy of Every Day Self-Management Strategies and the Behavior Change Technique Taxonomy version 1 identified common program content and behavior change strategies. However, distinct differences were evident based on whether program objectives were to improve physical activity or function (7/25, 28%) or mental health (7/25, 28%). Incorporating healthy behaviors was addressed in all programs designed to improve physical activity or function, whereas only 14% (1/7) of the programs targeting mental health covered content about healthy lifestyles. Managing emotional distress and social interaction were commonly discussed in programs with objectives of improving mental health (6/25, 24% and 4/25, 16%, respectively) but not in programs aiming at physical function (2/25, 8% and 0%, respectively). In total, 13 types of behavior change strategies were identified in the 25 programs. The top 3 types of strategies applied in programs intent on improving physical activity or function were feedback and monitoring, goals and planning, and social support, in contrast to shaping knowledge, regulation, and identity in programs with the goal of improving mental health. The findings suggest that chronic condition interventions continue to neglect evidence that exercise and strong relationships improve both physical and mental health. Videoconference interventions were seen as feasible and acceptable to clients. Challenges were mostly technology related: clients’ comfort, technology literacy, access to hardware and the internet, and technical breakdowns and issues. Only 15% (5/33) of the studies explicitly described compliance with health information or privacy protection regulations. Conclusions: Videoconferencing is a feasible and acceptable delivery format to engage clients in managing their conditions at home. Future program development could reduce siloed approaches by adding less used content and behavior change strategies. Addressing client privacy and technology issues should be priorities. %M 40009439 %R 10.2196/58543 %U https://www.jmir.org/2025/1/e58543 %U https://doi.org/10.2196/58543 %U http://www.ncbi.nlm.nih.gov/pubmed/40009439 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e68462 %T Impact of In-Person and Mobile Exercise Coaching on Psychosocial Factors Affecting Exercise Adherence in Inactive Women With Obesity: 20-Week Randomized Controlled Trial %A Gjestvang,Christina %A Kalhovde,John Magne %A Mauseth Tangen,Elene %A Clemm,Hege %A Haakstad,Lene Annette Hagen %+ Department of Sports Medicine, Norwegian School of Sport Sciences, P.O Box 4014, Ullevål Stadion, Oslo, 0806, Norway, 47 23262119, christina.gjestvang@nih.no %K barriers %K exercise behavior %K exercise coaching %K health-related quality of life %K motivation %K obesity %K psychosocial factors %K self-efficacy %K social support %D 2025 %7 25.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Regular exercise may counteract obesity-related health risks, but adherence is low among individuals with obesity. Personal trainers may positively influence exercise behavior by providing motivational support. Individuals who receive regular exercise coaching are more likely to adhere to their exercise routine, compared with those who exercise individually. However, investing in personalized exercise guidance, such as a personal trainer, can be expensive for the individual. Thus, integrating web-based coaching could be a more economically sustainable option, offering both flexibility and reduced costs compared with in-person coaching only. Yet, research is needed to assess the effect of hybrid models in improving psychosocial factors among women with obesity. Objective: This 20-week, pragmatic randomized controlled trial aimed to investigate the effect of weekly in-person coaching compared with 2 combinations of in-person and web-based coaching on 5 psychosocial factors in women with obesity (BMI ≥30 kg/m2). Methods: Participants were invited through Facebook and Instagram advertisements posted by various fitness clubs across rural and urban locations in Norway (7 different counties and 12 different municipalities). Women with low activity (n=188; <150 minutes of moderate-intensity physical activity/week; 42.7, SD 10.5 years; mean BMI of 35.1, SD 6.9 kg/m2) were allocated into 3 groups of in-person coaching—weekly (n=47), twice weekly (n=47), and once monthly (n=47)—and as controls (n=47). Those with twice weekly and once monthly in-person coaching received web-based coaching of 15 minutes during weeks without in-person coaching. Data included background variables, motivation (Behavioral Regulation in Exercise Questionnaire-2), barriers, self-efficacy (The Self-Efficacy Survey), social support (Social Support Questionnaire), and health-related quality of life (36-Item Short Form Health Survey [SF-36]). Results: A total of 120 (64%) out of 188 participants completed baseline and postintervention assessments. A minor difference was observed in one item of the SF-36, where all intervention groups reported a greater “change in health last year” than the control group (mean difference: 14.2-17.1, 95% CI 2.04-29.5; g=0.79-1.14; P≤.01). No other effects were found on the selected psychosocial factors. It should be noted that controls reported higher intrinsic motivational regulation at baseline than intervention groups (mean difference: 0.43-0.93; P≤.05). All intervention arms exercised more frequently than controls (mean difference: 1.1-1.5; P≤.001), with no differences in weekly exercise frequency between the 3 intervention arms (P=.30). Conclusions: We found no effects on motivation, barriers, self-efficacy, perceived social support, or other health domains compared with controls. All intervention groups reported a slight improvement in self-perceived health in 1 of the 8 subscales of the SF-36. Combined in-person and web-based coaching may give a minor improvement in self-perceived health in women with obesity. However, the lack of impact on motivation, barriers, and self-efficacy warrants further research. Trial Registration: ClinicalTrials.gov NCT05792657; https://clinicaltrials.gov/study/NCT05792657 %M 39999434 %R 10.2196/68462 %U https://www.jmir.org/2025/1/e68462 %U https://doi.org/10.2196/68462 %U http://www.ncbi.nlm.nih.gov/pubmed/39999434 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e64303 %T Culturally Adapted Guided Internet-Based Cognitive Behavioral Therapy for Hong Kong People With Depressive Symptoms: Randomized Controlled Trial %A Pan,Jia-Yan %A Rafi,Jonas %+ Department of Social Work, Hong Kong Baptist University, AAB1026, 10/F, Academic and Administration Building, 15 Baptist University Road, Baptist University Road Campus, Hong Kong Baptist University, Kowloon Tong, KLN, Hong Kong, China (Hong Kong), 852 34116415, jiayan@hkbu.edu.hk %K Internet-based cognitive behavioral therapy %K depression %K Chinese %K Hong Kong, culturally adapted internet intervention %D 2025 %7 25.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: A significant number of individuals with depression in Hong Kong remain undiagnosed and untreated through traditional face-to-face psychotherapy. Internet-based cognitive behavioral therapy (iCBT) has emerged as a tool to improve access to mental health services. However, iCBT remains underdeveloped in Chinese communities, particularly in Hong Kong. Objective: This study aims to (1) develop and evaluate the effectiveness of a culturally and linguistically appropriate guided iCBT program for Hong Kong Chinese with depressive symptoms, and (2) explore their treatment adherence. Methods: An 11-week guided iCBT program, “Confront and Navigate Depression Online” (CANDO), consisting of 8 online modules, was developed and implemented for Hong Kong residents. The program was accessible via either an online platform (web-based iCBT) or a smartphone app (app-based iCBT). A 3-arm randomized controlled trial was conducted, with participants recruited through open recruitment and referrals from 2 local non-governmental organizations. A total of 402 eligible participants with mild to moderate depressive symptoms were randomly allocated into 3 groups: (1) web-based iCBT (n=139); (2) app-based iCBT (n=131); and (3) waitlist control (WLC) group (n=132), who transitioned to the web-based iCBT group after waiting for 11 weeks. Therapist support was provided by a clinical psychologist through 3 counseling sessions and weekly assignment feedback. The primary outcomes were the Beck Depression Inventory-II (BDI-II) and the 9-item Patient Health Questionnaire (PHQ-9), while the secondary outcome measures included the 12-item General Health Questionnaire (GHQ-12), the Chinese Automatic Thoughts Questionnaire (CATQ), and the Chinese Affect Scale (CAS). These scales were administered at preintervention, postintervention, and at 3-month and 6-month follow-up assessments. Data analysis was conducted using linear mixed effects modeling, adhering to the intent-to-treat principle. Results: Participants in both the web- and app-based iCBT groups reported significant improvements compared with the WLC group on all primary (P<.001) and secondary measures (P<.001 and P=.009) at posttreatment. Large between-group effect sizes were observed in the reduction of depressive symptoms, with Cohen's d value of 1.07 (95% CI 0.81-1.34) for the web-based group and 1.15 (95% CI 0.88-1.43) for the app-based group on the BDI-II. Additionally, the web- and app-based groups showed effect sizes of 0.78 (95% CI 0.52-1.04) and 0.95 (95% CI 0.63-1.27) on PHQ-9, respectively. Medium to large effect sizes were observed for secondary outcomes at posttreatment. These positive effects were maintained at both the 3- and 6-month follow-ups, with medium to large within-group effect sizes. The adherence rate in the 2 iCBT groups was 154 out of 270 (57.0%) for completing all 8 online modules and 152 out of 270 (56.3%) for attending all 4 counseling sessions (including an intake interview). The recovery rate, as measured by the BDI-II at posttreatment, was 35 out of 90 (39%) for the web-based group and 36 out of 91 (40%) for the app-based group, compared with 3 out of 112 (3%) in the WLC group. Conclusions: Culturally and linguistically adapted iCBT is an effective and feasible treatment for Hong Kong Chinese with mild to moderate depressive symptoms, demonstrating a satisfactory recovery rate and treatment adherence. ICBT offers an accessible and viable alternative to face-to-face interventions in Hong Kong. The Hong Kong government should allocate more resources and support the use of iCBT as a tool to treat people with depressive symptoms. Trial Registration: ClinicalTrials.gov (NCT04388800); https://clinicaltrials.gov/study/NCT04388800 %M 39998865 %R 10.2196/64303 %U https://www.jmir.org/2025/1/e64303 %U https://doi.org/10.2196/64303 %U http://www.ncbi.nlm.nih.gov/pubmed/39998865 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 12 %N %P e63497 %T Patterns of Skills Review in Smartphone Cognitive Behavioral Therapy for Depression: Observational Study of Intervention Content Use %A Bernstein,Emily E %A Daniel,Katharine E %A Miyares,Peyton E %A Hoeppner,Susanne S %A Bentley,Kate H %A Snorrason,Ivar %A Fisher,Lauren B %A Greenberg,Jennifer L %A Weingarden,Hilary %A Harrison,Oliver %A Wilhelm,Sabine %+ University of Virginia, 560 Ray C Hunt Drive, Charlottesville, 22903, United States, 1 434 924 2495, ked4fd@virginia.edu %K smartphone %K cognitive behavioral therapy %K engagement %K depression %K mental health %K Mindset %K mHealth %K mobile health %K app %K digital health %K mobile phone %D 2025 %7 24.2.2025 %9 Original Paper %J JMIR Ment Health %G English %X Background: Smartphones could enhance access to effective cognitive behavioral therapy (CBT). Users may frequently and flexibly access bite-size CBT content on personal devices, review and practice skills, and thereby achieve better outcomes. Objective: We explored the distribution of actual interactions participants had with therapeutic content in a trial of smartphone CBT for depression and whether interactions were within assigned treatment modules or revisits to prior module content (ie, between-module interactions). Methods: We examined the association between the number of within- and between-module interactions and baseline and end-of-treatment symptom severity during an 8-week, single-arm open trial of a therapist-guided CBT for depression mobile health app. Results: Interactions were more frequent early in treatment and modestly declined in later stages. Within modules, most participants consistently made more interactions than required to progress to the next module and tended to return to all types of content rather than focus on 1 skill. By contrast, only 15 of 26 participants ever revisited prior module content (median number of revisits=1, mode=0, IQR 0-4). More revisits were associated with more severe end-of-treatment symptom severity after controlling for pretreatment symptom severity (P<.05). Conclusions: The results suggest that the frequency of use is an insufficient metric of engagement, lacking the nuance of what users are engaging with and when during treatment. This lens is essential for developing personalized recommendations and yielding better treatment outcomes. Trial Registration: ClinicalTrials.gov NCT05386329; https://clinicaltrials.gov/study/NCT05386329?term=NCT05386329 %M 39993308 %R 10.2196/63497 %U https://mental.jmir.org/2025/1/e63497 %U https://doi.org/10.2196/63497 %U http://www.ncbi.nlm.nih.gov/pubmed/39993308 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e56230 %T Improving Maternal Mental Health and Weight Control With a Mindfulness Blended Care Approach: Insights From a Randomized Controlled Trial %A Hassdenteufel,Kathrin %A Müller,Mitho %A Abele,Harald %A Brucker,Sara Yvonne %A Graf,Johanna %A Zipfel,Stephan %A Bauer,Armin %A Jakubowski,Peter %A Pauluschke-Fröhlich,Jan %A Wallwiener,Markus %A Wallwiener,Stephanie %+ Department of Obstetrics and Gynecology, University Hospital Heidelberg, Im Neuenheimer Feld 440, 69120 Heidelberg, Heidelberg, 69120, Germany, 49 15238492062, Kathrin.hassdenteufel@med.uni-heidelberg.de %K peripartum mental health %K digital intervention %K depression %K anxiety %K personal coaching %K ehealth %K pregnancy %K maternal mental health %K weight gain %K mindfulness-based intervention %K coaching %K randomized controlled clinical trial %K postpartum %K treatment %K electronic %K effectiveness %K women %K digital intervention %D 2025 %7 24.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Perinatal maternal mental health problems, such as depression and anxiety, are highly prevalent during pregnancy and post partum. Electronic mindfulness-based interventions (eMBIs) are a promising treatment option, which can be provided in a low-threshold, cost-effective manner. However, research underscores the fact that face-to-face coaching sessions are more effective than solely digital methods. A blended care approach (eMBI with direct face-to-face coaching) could amplify the therapeutic impact on maternal mental health and weight gain during the perinatal period. Objective: We investigated whether combining an eMBI intervention with face-to-face personal support significantly improves maternal mental health, and whether the intervention can influence weight gain in affected women during pregnancy. Methods: A community-based sample of 460 pregnant women with a singleton pregnancy who screened positive for depression was enrolled in a multicenter randomized controlled trial (RCT) including the University Hospitals of Heidelberg and Tübingen as well as more than 200 gynecological practices within the state of Baden-Württemberg in Germany between February 2019 and October 2020. Participating women were randomized 1:1 to the control group (CG) or intervention group (IG) that received access to an 8-week pregnancy-adapted eMBI between the 29th and 36th gestational week. In a subanalysis, we grouped participants in those receiving only the initial face-to-face coaching session at recruitment (no personal coaching) and those with ≥2 personal coaching sessions. Primary outcome measures were severity of depressive symptoms using the Edinburgh Postnatal Depression Scale, anxiety using the State-Trait Anxiety Inventory, the Pregnancy-Related Anxiety Questionnaire, the Freiburg Mindfulness Inventory, and the Patient Health Questionnaire; secondary outcome measure, BMI. Results: In the final sample, 137 CG women and 102 IG women received only one coaching session, whereas 37 CG women and 40 IG women received at least 2 (mean 2.3, SD 0.7) coaching sessions. The analyses were adjusted for significant confounders. The IG’s mindfulness scores increased significantly (F1.873,344.619=4.560, P=.01, η²=0.024, ω²=0.012) regardless of coaching frequency. Both general anxiety (F12,129=2.361, P=.01, η²=0.0180, ω²=0.100) and depression symptoms (F4.758, 699.423=3.033, P=.01, η²=0.020, ω²=0.009) were significantly lower in the group that received ≥2 coaching sessions than in the no-personal-coaching group. In the group receiving ≥2 coaching sessions, BMI generally was lower in the IG than in the CG (F3.555,444.416=4.732, P=.002, η²=0.036, ω²=0.013). Conclusions: Adding a minimal amount of PC to the digital eMBI increased mindfulness and decreased birth-related anxiety, symptoms of depression, and anxiety in at-risk pregnant women. Favorable effects on gestational weight gain were found in the respective IGs, the strongest effect being within the PC group. This blended digital health approach amplifies the effectiveness of the digital intervention. Trial Registration: German Clinical Trials Register DRKS00017210; https://www.drks.de/search/de/trial/DRKS00017210 %M 39992700 %R 10.2196/56230 %U https://www.jmir.org/2025/1/e56230 %U https://doi.org/10.2196/56230 %U http://www.ncbi.nlm.nih.gov/pubmed/39992700 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e69621 %T Digital Health Interventions to Improve Mental Health in Patients With Cancer: Umbrella Review %A Zhong,Chuhan %A Luo,Xian %A Tan,Miaoqin %A Chi,Jing %A Guo,Bingqian %A Tang,Jianyao %A Guo,Zihan %A Deng,Shisi %A Zhang,Yujie %A Wu,Yanni %+ Nanfang Hospital, Southern Medical University, No 1838 Guangzhou Avenue North, Baiyun District, Guangdong Province, Guangzhou, 510515, China, 86 18818860076, yanniwuSMU@126.com %K digital health care services %K mental health care %K oncology %K digital delivery modality %K umbrella review %K PRISMA %D 2025 %7 21.2.2025 %9 Review %J J Med Internet Res %G English %X Background: Mental health plays a key role across the cancer care continuum, from prognosis and active treatment to survivorship and palliative care. Digital health technologies offer an appealing, cost-effective tool to address psychological needs. Objective: This umbrella review aims to summarize and evaluate the available evidence on the efficacy of digital health interventions for improving mental health and psychosocial outcomes for populations with cancer. Methods: Literature searches were conducted in Embase, PsycINFO, PubMed, CINAHL, the Cochrane Library, and Web of Science from their inception to February 4, 2024. Systematic reviews (with or without meta-analysis) investigating the efficacy of digital health interventions for psychosocial variables in patients with cancer were included. Quality was assessed using the Assessing the Methodological Quality of Systematic Reviews-2 tool. Results: In total, 78 systematic reviews were included in this review. Among diverse delivery modalities and types of digital interventions, websites and smartphone apps were the most commonly used. Depression was the most frequently addressed, followed by quality of life, anxiety, fatigue, and distress. The qualities of the reviews ranged from critically low to high. Generally, despite great heterogeneity in the strength and credibility of the evidence, digital health interventions were shown to be effective for mental health in patients with cancer. Conclusions: Taken together, digital health interventions show benefits for patients with cancer in improving mental health. Various gaps were identified, such as little research specifically focusing on older adult patients with cancer, a scarcity of reporting high-precision emotion management, and insufficient attention to other certain mood indicators. Further exploration of studies with standardized and rigorous approaches is required to inform practice. Trial Registration: PROSPERO CRD42024565084; https://tinyurl.com/4cbxjeh9 %M 39984165 %R 10.2196/69621 %U https://www.jmir.org/2025/1/e69621 %U https://doi.org/10.2196/69621 %U http://www.ncbi.nlm.nih.gov/pubmed/39984165 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e67962 %T Usability Testing of a Bystander Bullying Intervention for Rural Middle Schools: Mixed Methods Study %A Midgett,Aida %A Doumas,Diana M %A Peralta,Claudia %A Peck,Matt %A Reilly,Blaine %A Buller,Mary K %+ Boise State University, 301 University Drive, Boise, ID, 83706, United States, 1 426 1214, AidaMidgett@boisestate.edu %K technology-based bullying intervention %K STAC-T %K usability testing %K middle school %K rural %D 2025 %7 21.2.2025 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Targets of bullying are at high risk of negative socioemotional outcomes. Bullying programming in rural schools is important as bullying is more prevalent in those schools compared to urban schools. Comprehensive, school-wide bullying programs require resources that create significant barriers to implementation for rural schools. Because technology-based programs can reduce implementation barriers, the development of a technology-based program increases access to bullying prevention in rural settings. Objective: We aimed to conduct usability testing of a bystander bullying intervention (STAC-T). We assessed usability and acceptability of the STAC-T application and differences in usability between school personnel and students. We were also interested in qualitative feedback about usability, program features, and feasibility. Methods: A sample of 21 participants (n=10, 48% school personnel; n=11, 52% students) recruited from 2 rural middle schools in 2 states completed usability testing and a qualitative interview. We used descriptive statistics and 2-tailed independent-sample t tests to assess usability and program satisfaction. We used consensual qualitative research as a framework to extract themes about usefulness, relevance, needs, barriers, and feedback for intervention development. Results: Usability testing indicated that the application was easy to use, acceptable, and feasible. School personnel (mean score 96.0, SD 3.9) and students (mean score 88.6, SD 9.5) rated the application well above the standard cutoff score for above-average usability (68.0). School personnel (mean score 6.10, SD 0.32) and students (mean score 6.09, SD 0.30) gave the application high user-friendliness ratings (0-7 scale; 7 indicates highest user-friendliness). All 10 school personnel stated they would recommend the program to others, and 90% (9/10) rated the program with 4 or 5 stars. Among students, 91% (10/11) stated they would recommend the program to others, and 100% (11/11) rated the program with 4 or 5 stars. There were no statistically significant differences in ratings between school personnel and students. Qualitative data revealed school personnel and students found the application useful, relevant, and appropriate while providing feedback about the importance of text narration and the need for teacher and parent training to accompany the student program. The data showed that school personnel and students found a tracker to report different types of bullying witnessed and strategies used to intervene by students a useful addition to STAC-T. School personnel reported perceiving the program to be practical and very likely to be adopted by schools, with time, cost, and accessibility being potential barriers. Overall, findings suggest that the STAC-T application has the potential to increase access to bullying prevention for students in rural communities. Conclusions: The results demonstrate high usability and acceptability of STAC-T and provide support for implementing a full-scale randomized controlled trial to test the efficacy of the application. %M 39984169 %R 10.2196/67962 %U https://humanfactors.jmir.org/2025/1/e67962 %U https://doi.org/10.2196/67962 %U http://www.ncbi.nlm.nih.gov/pubmed/39984169 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e64178 %T Examining the Implementation of the Italian Version of the Teen Online Problem-Solving Program Coupled With Remote Psychological Support: Protocol for a Randomized Controlled Trial %A Corti,Claudia %A Papini,Marta %A Strazzer,Sandra %A Borgatti,Renato %A Romaniello,Romina %A Poggi,Geraldina %A Storm,Fabio Alexander %A Urgesi,Cosimo %A Jansari,Ashok %A Wade,Shari L %A Bardoni,Alessandra %+ , Scientific Institute, IRCCS E. Medea, Via Don Luigi Monza, 20, Bosisio Parini, 23842, Italy, 39 031 877111, claudia.corti@lanostrafamiglia.it %K telerehabilitation %K acquired brain injury %K executive functioning %K pediatric %K problem-solving %K computer %D 2025 %7 21.2.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Pediatric acquired brain injury (ABI) is frequently associated with cognitive and socioemotional alterations. Therefore, targeted rehabilitation to improve everyday functioning, particularly executive functioning (EF), is needed to limit the possible deterioration of cognitive abilities and behavior over time and the associated social and psychological costs. Objective: In this paper, we present the protocol for a phase-2 randomized controlled trial (RCT) aimed at examining the feasibility and efficacy of a web-based intervention (ie, the Italian version of the Teen Online Problem-Solving [I-TOPS] intervention) to improve problem-solving abilities versus an active-control, web-based intervention (ie, wellness intervention) providing health and wellness content. Methods: A double-blinded, phase-2 RCT will be conducted to guarantee controls on data quality and findings. In total, 42 adolescents will be recruited from a rehabilitation institute and individually randomly assigned in a 1:1 ratio to receive the I-TOPS intervention or the web-based wellness intervention. Both interventions will include 10 core sessions and will be delivered remotely using a web-based platform. Participants allocated to both interventions and their caregivers will independently complete the learning modules in an everyday setting using their computer. The I-TOPS intervention’s core sessions will target the EF domain (eg, planning, emotion regulation, and social skills), while all the contents of the wellness intervention will be aimed at providing psychoeducation on ABI sequelae and supporting health and wellness. Participants assigned to the I-TOPS intervention will also receive bimonthly direct training in problem-solving coupled with remote support from a psychologist. Feasibility data and efficacy outcomes on both adolescents’ and parents’ functioning will be assessed. Cognitive abilities in the EF domain and behavioral and psychological functioning (ie, internalizing and externalizing symptoms) of the adolescents will be evaluated via performance-based measures, administered remotely using the Google Meet platform, and paper-and-pencil questionnaires; parents’ well-being will be assessed through paper-and-pencil questionnaires. Efficacy will be evaluated immediately after training and at 6-month follow-up. Results: This study started on February 26, 2021, and ended on February 28, 2023. A total of 42 adolescents were enrolled and randomly assigned to the 2 study groups, 34 (81%) completed the intervention and posttreatment evaluation (I-TOPS: n=19 and wellness intervention: n=15) and 31 performed follow-up evaluation (I-TOPS: n=18 and wellness intervention: n=13). Data analysis on feasibility and efficacy will be performed after protocol publication, and the results will be published in the form of a paper in a relevant journal in 2025. Conclusions: This double-blinded, phase-2 RCT could extend knowledge on the best rehabilitation practices to adopt with the survivors of pediatric ABI by providing evidence-based data currently lacking for the Italian context. If this study yields positive results, a larger, multicenter, phase-3 RCT could be planned and delivered to examine program cost-effectiveness in a larger sample. Trial Registration: ClinicalTrials.gov NCT05169788; https://clinicaltrials.gov/study/NCT05169788 International Registered Report Identifier (IRRID): DERR1-10.2196/64178 %M 39984161 %R 10.2196/64178 %U https://www.researchprotocols.org/2025/1/e64178 %U https://doi.org/10.2196/64178 %U http://www.ncbi.nlm.nih.gov/pubmed/39984161 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e63898 %T Digital Interventions for Older People Experiencing Homelessness: Systematic Scoping Review %A Adams,Emily %A Donaghy,Eddie %A Sanders,Caroline %A Wolters,Maria Klara %A Ng,Lauren %A St-Jean,Christa %A Galan,Ryan %A Mercer,Stewart William %+ Advanced Care Research Centre, Usher Institute, University of Edinburgh, BioQuarter (Gate, 5-7), 3 Little France Rd, Edinburgh, EH16 4U, United Kingdom, 44 0131 651 7869, stewart.mercer@ed.ac.uk %K homeless %K technology %K digital exclusion %K elderly %K rough sleeping %K digital intervention %K older people %K homelessness %K systematic scoping review %K aging %K premature mortality %K indicators %K scoping review %K databases %K thematic analysis %K telehealth %K mhealth %K ehealth %D 2025 %7 21.2.2025 %9 Review %J J Med Internet Res %G English %X Background: older people experiencing homelessness can have mental and physical indicators of aging several decades earlier than the general population and experience premature mortality due to age-related chronic conditions. Digital interventions could positively impact the health and well-being of homeless people. However, increased reliance on digital delivery may also perpetuate digital inequalities for socially excluded groups. The potential triple disadvantage of being older, homeless, and digitally excluded creates a uniquely problematic situation warranting further research. Few studies have synthesized available literature on digital interventions for older people experiencing homelessness. Objective: This scoping review examined the use, range, and nature of digital interventions available to older people experiencing homelessness and organizations supporting them. Methods: The scoping review followed Arksey and O’Malley’s proposed methodology, PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines, and recent Joanna Briggs Institute guidelines. We searched 14 databases. Gray literature sources were searched to supplement the electronic database search. A narrative synthesis approach was conducted on the included articles, and common themes were identified inductively through thematic analysis. Results: A total of 19,915 records were identified through database and gray literature searching. We identified 10 articles reporting on digital interventions that had a clearly defined a participant age group of >50 years or a mean participant age of >50 years. A total of 9 of 10 studies were published in the United States. The study design included descriptive studies, uncontrolled pilot studies, and pilot randomized controlled trials. No studies aimed to deliver an intervention exclusively to older people experiencing homelessness or organizations that supported them. Four types of intervention were identified: telecare for people experiencing homelessness, distributing technology to enable digital inclusion, text message reminders, and interventions delivered digitally. Interventions delivered digitally included smoking cessation support, vocational training, physical activity promotion, and cognitive behavioral therapy. Overall, the included studies demonstrated evidence for the acceptability and feasibility of digital interventions for older people experiencing homelessness, and all 10 studies reported some improvements in digital inclusion or enhanced engagement among participants. However, several barriers to digital interventions were identified, particularly aspects related to digital inclusion, such as infrastructure, digital literacy, and age. Proposed facilitators for digital interventions included organizational and peer support. Conclusions: Our findings highlight a paucity of evaluated digital interventions targeted at older people experiencing homelessness. However, the included studies demonstrated evidence of the acceptability and feasibility of digital interventions for older people experiencing homelessness. Further research on digital interventions that provide services and support older people experiencing homelessness is required. Future interventions must address the barriers older people experiencing homelessness face when accessing digital technology with the input of those with lived experience of homelessness. Trial Registration: OSF Registries OSF.IO/7QGTY; https://doi.org/10.17605/OSF.IO/7QGTY %M 39984162 %R 10.2196/63898 %U https://www.jmir.org/2025/1/e63898 %U https://doi.org/10.2196/63898 %U http://www.ncbi.nlm.nih.gov/pubmed/39984162 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e60527 %T Enhancing Text Message Support With Media Literacy and Financial Incentives for Vaping Cessation in Young Adults: Protocol for a Pilot Randomized Controlled Trial %A Michaud,Tzeyu %A Puga,Troy %A Archer,Rex %A Theye,Elijah %A Zagurski,Cleo %A Estabrooks,Paul %A Dai,Hongying Daisy %+ Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, 986075 Nebraska Medical Center, Omaha, NE, 68198, United States, 1 4028369195, tzeyu.michaud@unmc.edu %K contingency management %K e-cigarettes %K social support %K youth %K electronic health record %K opt-in %K recruitment %K tobacco marketing %K cessation %K peer support %K young adult %K feasibility %K public health %D 2025 %7 21.2.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: The persistent high prevalence of e-cigarette use among young adults remains a significant public health concern, with limited evidence and guidance on effective vaping cessation programs targeting this population. Objective: This study aims to outline the study design and protocol of a pilot randomized controlled trial aimed at investigating feasibility and assessing whether media literacy education or financial incentives enhance the effectiveness of evidence-based text message support in promoting vaping abstinence among young adult e-cigarette users. Methods: The pilot study uses a 4-arm (1:1:1:1) randomized controlled trial design to assess the potential impact of different combinations of media literacy education, financial incentives, and text message support on vaping abstinence over a 3-month period. The first month serves as a preparatory phase for quitting, followed by 2 months focused on abstinence. A total of 80 individuals, aged 19-29 years, who have used e-cigarettes within the past 30 days, have internet access, and express interest in quitting vaping within the next 30 days, will be enrolled. Eligible individuals will be randomized into one of the four study groups: (1) Text Message, (2) Media Literacy, (3) Financial Incentive, and (4) Combined. All participants, regardless of group assignment, will receive text message support. Participants will be followed for 12 weeks, with abstinence status assessed at week 12, as well as during remote check-ins at weeks 6, 8, and 10. Feasibility measures include recruitment rate, reach, engagement, and retention. Other outcomes of interest include self-reported 7-day abstinence and changes in nicotine dependence and media literacy scores. Exit interviews will be conducted with those who complete the study to explore facilitators of and barriers to participation and engagement in vaping cessation, which will inform future program refinement and uptake. Results: Recruitment for the study commenced in December 2023 and concluded in August 2024. A total of 40 participants were randomized into these groups: 9 for Text Message, 11 for Media Literacy, 10 for Financial Incentive, and 10 for the Combined group. The final assessment was completed in November 2024, and analyses are currently ongoing. Conclusions: The findings from this trial could provide valuable insights into the design and uptake of vaping cessation strategies among the young adult population. Trial Registration: ClinicalTrials.gov NCT05586308; https://clinicaltrials.gov/study/NCT05586308 International Registered Report Identifier (IRRID): DERR1-10.2196/60527 %M 39983103 %R 10.2196/60527 %U https://www.researchprotocols.org/2025/1/e60527 %U https://doi.org/10.2196/60527 %U http://www.ncbi.nlm.nih.gov/pubmed/39983103 %0 Journal Article %@ 2564-1891 %I JMIR Publications %V 5 %N %P e56831 %T Transformer-Based Tool for Automated Fact-Checking of Online Health Information: Development Study %A Bayani,Azadeh %A Ayotte,Alexandre %A Nikiema,Jean Noel %+ , Laboratoire Transformation Numérique en Santé, LabTNS, 7101 Av. du Parc, Montréal,, Montreal, QC, H3N 1X9, Canada, 1 4389980241, azadeh.bayani@umontreal.ca %K fact-checking automation %K transformers %K infodemic %K credible health information %K machine learning %K automated %K online health information %K misinformation %K natural language processing %K epidemiology %K health domain %D 2025 %7 21.2.2025 %9 Original Paper %J JMIR Infodemiology %G English %X Background: Many people seek health-related information online. The significance of reliable information became particularly evident due to the potential dangers of misinformation. Therefore, discerning true and reliable information from false information has become increasingly challenging. Objective: This study aimed to present a pilot study in which we introduced a novel approach to automate the fact-checking process, leveraging PubMed resources as a source of truth using natural language processing transformer models to enhance the process. Methods: A total of 538 health-related web pages, covering 7 different disease subjects, were manually selected by Factually Health Company. The process included the following steps: (1) using transformer models of bidirectional encoder representations from transformers (BERT), BioBERT, and SciBERT, and traditional models of random forests and support vector machines, to classify the contents of web pages into 3 thematic categories (semiology, epidemiology, and management), (2) for each category in the web pages, a PubMed query was automatically produced using a combination of the “WellcomeBertMesh” and “KeyBERT” models, (3) top 20 related literatures were automatically extracted from PubMed, and finally, (4) the similarity checking techniques of cosine similarity and Jaccard distance were applied to compare the content of extracted literature and web pages. Results: The BERT model for the categorization of web page contents had good performance, with F1-scores and recall of 93% and 94% for semiology and epidemiology, respectively, and 96% for both the recall and F1-score for management. For each of the 3 categories in a web page, 1 PubMed query was generated and with each query, the 20 most related, open access articles within the category of systematic reviews and meta-analyses were extracted. Less than 10% of the extracted literature was irrelevant; those were deleted. For each web page, an average of 23% of the sentences were found to be very similar to the literature. Moreover, during the evaluation, it was found that cosine similarity outperformed the Jaccard distance measure when comparing the similarity between sentences from web pages and academic papers vectorized by BERT. However, there was a significant issue with false positives in the retrieved sentences when compared with accurate similarities, as some sentences had a similarity score exceeding 80%, but they could not be considered similar sentences. Conclusions: In this pilot study, we have proposed an approach to automate the fact-checking of health-related online information. Incorporating content from PubMed or other scientific article databases as trustworthy resources can automate the discovery of similarly credible information in the health domain. %M 39812653 %R 10.2196/56831 %U https://infodemiology.jmir.org/2025/1/e56831 %U https://doi.org/10.2196/56831 %U http://www.ncbi.nlm.nih.gov/pubmed/39812653 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e65214 %T Behavior Change Support Systems for Self-Treating Procrastination: Systematic Search in App Stores and Analysis of Motivational Design Archetypes %A Kirchner-Krath,Jeanine %A Schmidt-Kraepelin,Manuel %A Schmähl,Katharina %A Schütz,Christoph %A Morschheuser,Benedikt %A Sunyaev,Ali %+ Department of Economics and Management, Karlsruhe Institute of Technology, Kaiserstraße 89, Karlsruhe, D-76133, Germany, 49 72160844062, manuel.schmidt-kraepelin@kit.edu %K procrastination %K mobile apps %K cluster analysis %K motivational design %K persuasive technology %K behavior change support systems %K behavior change techniques %K mobile health %K mHealth %K mobile phone %K artificial intelligence %K AI %D 2025 %7 20.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: The phenomenon of procrastination refers to an individual’s conscious decision to postpone the completion of tasks despite being aware of its adverse consequences in the future. Extant research in this field shows that procrastination is associated with increased levels of anxiety and stress and the likelihood of developing depression and calls for the development of suitable interventions that support individuals in making lasting positive changes to their procrastination behaviors. In parallel, practice has produced a plethora of behavior change support systems (BCSSs) that aim to provide a low-threshold, accessible alternative to in-person therapeutic approaches. Most of these BCSSs can be considered motivational BCSSs that combine functional, utilitarian components with hedonic and eudaimonic design elements to empower self-treatment. Although early studies have suggested the potential benefits of such BCSSs, research on understanding their specific design characteristics and support of individuals in self-treating procrastination is still in its infancy. Objective: In response to this gap between practice and research, we aimed to analyze and systemize the multitude of practical design efforts in motivational BCSSs for the self-treatment of procrastination and identify the main design archetypes that have emerged. Methods: We conducted a 3-step research approach. First, we identified 127 behavior change support apps for procrastination through a systematic screening process in the German and US Apple App Store and Google Play Store. Second, we systematically coded the identified apps in terms of the behavior change techniques targeted by their functional design and hedonic or eudaimonic design elements. Third, we conducted a 2-step cluster analysis to identify archetypes of motivational design in behavior change support apps to combat procrastination. Results: A variety of motivational designs have been developed and implemented in practice, and our analysis identified five main archetypes: (1) structured progress monitor, (2) self-improvement guide, (3) productivity adventure, (4) emotional wellness coach, and (5) social focus companion. The identified archetypes target different psychological determinants of procrastination and successfully use a variety of hedonic and eudaimonic design elements that extend beyond the current state of research. Conclusions: The results of our study provide a foundation for future research endeavors that aim to examine the comparative effects of motivational design archetypes and develop more effective interventions tailored to individual needs. For practitioners, the findings reveal the contemporary design space of motivational BCSSs to support the self-treatment of procrastination and may serve as blueprints that can guide the design of future systems. For individuals seeking support and health professionals treating procrastination, our study systemizes the landscape of apps, thereby facilitating the selection of one that best aligns with the patient’s individual needs. %M 39977017 %R 10.2196/65214 %U https://www.jmir.org/2025/1/e65214 %U https://doi.org/10.2196/65214 %U http://www.ncbi.nlm.nih.gov/pubmed/39977017 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e53087 %T Evaluation of the Quality of Delirium Website Content for Patient and Family Education: Cross-Sectional Study %A Krewulak,Karla %A Strayer,Kathryn %A Jaworska,Natalia %A Spence,Krista %A Foster,Nadine %A Kupsch,Scotty %A Sauro,Khara %A Fiest,Kirsten M %+ , Department of Critical Care Medicine, University of Calgary, MT 04111, 3260 Hospital Drive NW, Calgary, AB, , Canada, 1 9448768, kmfiest@ucalgary.ca %K education %K health information %K internet %K delirium %K patient %K caregiver %K brain lesions %K confusion %K inattentiveness %K disorientation %K family education %K information seeking %K readability %K high-quality websites %K accessibility %D 2025 %7 20.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Patients and families who have experienced delirium may seek information about delirium online, but the quality and reliability of online delirium-related websites are unknown. Objective: This study aimed to identify and evaluate online delirium-related websites that could be used for patient and family education. Methods: We searched Microsoft Bing, Google, and Yahoo using the keywords “delirium” and the misspelled “delerium” to identify delirium-related websites created to inform patients, families, and members of the public about delirium. The quality of identified delirium-related website content was evaluated by 2 authors using the validated DISCERN tool and the JAMA (Journal of the American Medical Association) benchmark criteria. Readability was assessed with the Simple Measure of Gobbledygook, the Flesch Reading Ease score, and the Flesch Kincaid grade level. Each piece of website content was assessed for its delirium-related information using a checklist of items co-designed by a working group, which included patients, families, researchers, and clinicians. Results: We identified 106 websites targeted toward patients and families, with most hospital-affiliated (21/106, 20%) from commercial websites (20/106, 19%), government-affiliated organizations (19/106, 18%), or from a foundation or advocacy group (16/106, 15%). The median time since the last content update was 3 (IQR 2-5) years. Most websites’ content (101/106, 95%) was written at a reading level higher than the recommended grade 6 level. The median DISCERN total score was 42 (IQR 33-50), with scores ranging from 20 (very poor quality) to 78 (excellent quality). The median delirium-related content score was 8 (IQR 6-9), with scores ranging from 1 to 12. Many websites lacked information on the short- and long-term outcomes of delirium as well as how common it is. The median JAMA benchmark score was 1 (IQR 1-3), indicating the quality of the websites’ content had poor transparency. Conclusions: We identified high-quality websites that could be used to educate patients, families, or the public about delirium. While most delirium-related website content generally meets quality standards based on DISCERN and JAMA benchmark criteria, high scores do not always ensure patient and family-friendliness. Many of the top-rated delirium content were text-heavy and complex in layout, which could be overwhelming for users seeking clear, concise information. Future efforts should prioritize the development of websites with patients and families, considering usability, accessibility, and cultural relevance to ensure they are truly effective for delirium education. %M 39977019 %R 10.2196/53087 %U https://www.jmir.org/2025/1/e53087 %U https://doi.org/10.2196/53087 %U http://www.ncbi.nlm.nih.gov/pubmed/39977019 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 8 %N %P e60315 %T Simulation of Contraceptive Access for Adolescents and Young Adults Using a Pharmacist-Staffed e-Platform: Development, Usability, and Pilot Testing Study %A Knowles,Kayla %A Lee,Susan %A Yapalater,Sophia %A Taylor,Maria %A Akers,Aletha Y %A Wood,Sarah %A Dowshen,Nadia %+ PolicyLab, Children's Hospital of Philadelphia, 3401 Civic Center Blvd, Philadelphia, PA, 19104, United States, 1 267 425 1449, knowlesk1@chop.edu %K adolescent %K contraception %K telemedicine %K user-centered design %K young adult %K reproductive %K design %K usability %K experience %K mHealth %K mobile health %K app %K youth %K teenager %K drug %K pharmacology %K pharmacotherapy %K pharmaceutics %K medication %K pharmacy %K digital health %K platform %K access %D 2025 %7 19.2.2025 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Offering contraceptive methods at pharmacies without a prescription is an innovative solution to reduce the incidence of unintended pregnancies among adolescents and young adults (AYA). Pharmacy-prescribed contraception may increase the convenience, simplicity, and affordability of contraceptives. Objective: The aim of this study was to develop, pilot test, and evaluate the acceptability and feasibility of a telemedicine electronic platform app simulating pharmacist prescribing of contraceptives to AYA as well as assess agreement between pharmacist-simulated contraceptive approvals and contraception as prescribed in routine clinic visits. Methods: This study was conducted in two phases: (1) development and usability testing of a prototype app to simulate pharmacists prescribing contraceptives to AYA and (2) pilot testing the app in a simulation for AYA requesting contraception from a pharmacist with pharmacist review and request approval or rejection. Eligibility criteria in both phases included the following: assigned female sex at birth, age 15-21 years, seeking contraceptive services at an academic adolescent medicine clinic, prior history of or intention to have penile-vaginal intercourse in the next 12 months, smartphone ownership, and English language proficiency. Phase 1 (usability) involved a video-recorded “think aloud” interview to share feedback and technical issues while using the app prototype on a smartphone and the completion of sociodemographic, sexual history, and perception of the prototype surveys to further develop the app. Phase 2 (pilot) participants completed phase 1 surveys, tested the updated app in a simulation, and shared their experiences in an audio-recorded interview. Descriptive analyses were conducted for quantitative survey data, and thematic analyses were used for interview transcripts. Results: Of the 22 participants, 10 completed usability testing, with a mean age of 16.9 (SD 1.97) years, and 12 completed pilot testing, with a mean age of 18.25 (SD 1.48) years. Three issues with the prototype were identified during “think aloud” interviews: challenges in comprehension of medical language, prototype glitches, and graphic design suggestions for engagement. Usability testing guided the frontend and backend creation of the platform. Overall, participants agreed or strongly agreed that using an app to receive contraceptives would make it easier for teens to access (n=19, 86%) and make contraceptive use less stigmatizing (n=19, 86%). In addition, participants agreed that receiving contraception prescriptions from a pharmacist without a clinic visit would be safe (n=18, 82%), convenient (n=19, 86%), acceptable (n=18, 82%), and easy (n=18, 82%). Pharmacists and medical providers had 100% agreement on the prescribed contraceptive method for pilot participants. Conclusions: AYA found contraceptive prescription by a pharmacist via an app to be highly acceptable and provided critical feedback to improve the design and delivery of the app. Additionally, pharmacist contraceptive approvals and contraception as prescribed in routine clinic visits were identical. %M 39970429 %R 10.2196/60315 %U https://pediatrics.jmir.org/2025/1/e60315 %U https://doi.org/10.2196/60315 %U http://www.ncbi.nlm.nih.gov/pubmed/39970429 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e67567 %T Cost Utility Analysis of Internet-Based Cognitive Behavioral Therapy for Major Depressive Disorder: Randomized Controlled Trial %A Zhou,Wenjing %A Chen,Yan %A Wu,Herui %A Zhao,Hao %A Li,Yanzhi %A Shi,Guangduoji %A Wang,Wanxin %A Liu,Yifeng %A Liao,Yuhua %A Zhang,Huimin %A Gao,Caihong %A Hao,Jiejing %A Le,Gia Han %A McIntyre,Roger S %A Han,Xue %A Lu,Ciyong %+ Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, No.74 Zhongshan Road 2, Guangzhou, 510080, China, 86 13610355985, luciyong@mail.sysu.edu.cn %K cost utility analysis %K CUA %K cost-effectiveness %K economic evaluation %K costs %K quality of life %K internet-based cognitive behavioral therapy %K ICBT %K digital psychiatry %K major depressive disorder %K depression %K China %D 2025 %7 19.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Unguided internet-based cognitive behavioral therapy (ICBT) has been proven effective for major depressive disorder (MDD). However, few studies have examined its cost-effectiveness in low-resource countries and under nonspecialist routine care. Objective: This study aimed to evaluate the short- and long-term cost utility of unguided ICBT compared to a waitlist control for persons with MDD from the perspectives of society and the health care system. Methods: This analysis was implemented alongside an 8-week 2-arm randomized controlled trial with a 12-month follow-up period conducted in Shenzhen, China. Outcomes including cost and health utility were collected at the pretreatment and posttreatment time points and 3, 6, and 12 months after the intervention. Direct medical costs and indirect costs were prospectively collected using the hospital information system and the Sheehan Disability Scale. Health outcomes were measured using the Chinese version of the Short-Form Six-Dimension health index. The primary outcome was incremental cost utility ratio (ICUR) expressed as the difference in costs between 2 therapies by the difference in quality-adjusted life years (QALYs). The seemingly unrelated regression model and the bootstrap method were performed to estimate adjusted ICURs. Cost-effectiveness planes and cost-effectiveness acceptability curves were used to demonstrate uncertainty. A series of scenario analyses were conducted to verify the robustness of base-case results. Results: In total, 244 participants with MDD were randomly allocated to the ICBT (n=122, 50%) or waitlist control (n=122, 50%) groups. At the pretreatment time point, no statistically significant difference was observed in direct medical cost (P=.41), indirect cost (P=.10), or health utility (P=.11) between the 2 groups. In the base-case analysis, the ICBT group reported higher direct medical costs and better quality of life but lower total costs at the posttreatment time point. The adjusted ICURs at the posttreatment time point were CN ¥–194,720.38 (US $–26,551.50; 95% CI CN ¥–198,766.78 to CN ¥–190,673.98 [US $–27,103.20 to US $–25,999.70]) and CN ¥49,700.33 (US $6776.99; 95% CI CN ¥46,626.34-CN ¥52,774.31 [US $6357.83-$7196.15]) per QALY from the societal and health care system perspectives, respectively, with a probability of unguided ICBT being cost-effective of 75.93% and 54.4%, respectively, if the willingness to pay was set at 1 time the per-capita gross domestic product. In the scenario analyses, the probabilities increased to 76.85% and 77.61%, respectively, indicating the potential of ICBT to be cost-effective over the long term. Conclusions: Unguided ICBT is a cost-effective treatment for MDD. This intervention not only helps patients with MDD improve clinically but also generates societal savings. These findings provide health economic evidence for a potential scalable MDD treatment method in low- and middle-income countries. Trial Registration: Chinese Clinical Trial Registry (ChiCTR) ChiCTR2100046425; https://tinyurl.com/bdcrj4zv %M 39970426 %R 10.2196/67567 %U https://www.jmir.org/2025/1/e67567 %U https://doi.org/10.2196/67567 %U http://www.ncbi.nlm.nih.gov/pubmed/39970426 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e69109 %T Evaluating the Clinical Efficacy of an Exergame-Based Training Program for Enhancing Physical and Cognitive Functions in Older Adults With Mild Cognitive Impairment and Dementia Residing in Rural Long-Term Care Facilities: Randomized Controlled Trial %A Li,Aoyu %A Qiang,Wei %A Li,Jingwen %A Geng,Yan %A Qiang,Yan %A Zhao,Juanjuan %+ School of Software, Taiyuan University of Technology, No. 319, University Street, Yuji District, Jingzhong, 030600, China, 86 18636664123, zhaojuanjuan@tyut.edu.cn %K exergame %K mild cognitive impairment %K dementia %K long-term care facilities %K multicomponent training %D 2025 %7 19.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Cognitive impairment is an important public health challenge among older adults, particularly in long-term care facilities (LTCFs), where prevalence is higher due to staffing shortages, limited resources, and difficulty maintaining structured exercise programs. Furthermore, older adults often lose interest in repetitive interventions. The exergame “WarioWare: Move It!” (Nintendo) offers a novel solution by combining aerobic exercise, motor coordination, balance training, and cognitive engagement into an immersive experience. Objective: This study aimed to assess the clinical efficacy of an exergame-based training program delivered via “WarioWare: Move It!” in improving physical flexibility, joint range of motion, motor coordination, hand dexterity, and cognitive function in older adults living in LTCFs. Methods: The training program was conducted across multiple rural LTCFs in Shanxi Province, China. Participants were randomly assigned to the intervention or control group. The intervention protocol encompassed two 60-minute sessions per week over 12 weeks, using motion-sensing exercises such as waving, jumping, arm swinging, rotational movements, and object-mimicking postures with Joy-Con controllers. Primary outcome measures were derived through clinical tests, including the sit and reach test, shoulder flexibility test, trunk rotation flexibility test, shoulder and elbow range of motion, figure-of-8 walk test, standing balance test, hand dexterity test, and cognitive function tests. Statistical analysis was performed using mixed ANOVA, with time as the within-participant factor and intervention group as the between-participant factor, to assess the training effects on the various outcome measures. Results: A total of 232 participants were recruited, including 32 (13.8%) patients with mild dementia, 18 (7.8%) with moderate dementia, and 182 (78.4%) with mild cognitive impairment, all of whom completed the study. The mixed ANOVA revealed significant group × time interactions across multiple physical flexibility assessments, including the remaining distance between the hands and toes during the forward bend (F2,156=8.484; P<.001; η²=0.098), the distance between the hands clasped behind the back (F2,156=3.666; P=.04; η²=0.045), and the angle formed by trunk rotation to the left and right (F2,156=17.353; P<.001; η²=0.182). Significant group × time interactions also emerged for shoulder joint forward flexion (F2,156=17.655; P<.001; η²=0.185), abduction (F2,156=6.281; P=.004; η²=0.075), and elbow flexion (F2,156=3.298; P=.049; η²=0.041). In addition, the time to complete the figure-of-8 walk test (F2,156=11.846; P<.001; η²=0.132) and the number of blocks moved within 1 minute (F2,156=4.016; P=.02; η²=0.049) showed significant interactions. Finally, all scale-based measures exhibited statistically significant group × time interactions (all P values <.001). Conclusions: The “WarioWare: Move It!” intervention significantly improved physical flexibility, joint range of motion, motor coordination, hand dexterity, and cognitive function among older adults with mild cognitive impairment or dementia residing in rural LTCFs. The intervention offers an innovative and feasible approach for promoting the health of older adults in resource-limited settings, demonstrating its potential for widespread application in diverse low-resource environments. Trial Registration: ClinicalTrials.gov NCT06717971; https://clinicaltrials.gov/study/NCT06717971 %M 39969990 %R 10.2196/69109 %U https://www.jmir.org/2025/1/e69109 %U https://doi.org/10.2196/69109 %U http://www.ncbi.nlm.nih.gov/pubmed/39969990 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e65302 %T Digital Solution to Support Medication Adherence and Self-Management in Patients with Cancer (SAMSON): Pilot Randomized Controlled Trial %A Dang,Thu Ha %A Wickramasinghe,Nilmini %A Jayaraman,Prem Prakash %A Burbury,Kate %A Alexander,Marliese %A Whitechurch,Ashley %A Dyer,Mitchell %A Quinn,Stephen %A Forkan,Abdur Rahim Mohammad %A Schofield,Penelope %+ Department of Psychological Sciences, School of Health Sciences, Swinburne University of Technology, John Street, Hawthorn, Melbourne, 3122, Australia, 61 422703347, thuhadang@swin.edu.au %K home-based cancer treatment %K smartphone app %K oral chemotherapy %K patient safety %K SAMSON %K mobile phone %K digital solution %K medication adherence %K self-management %K cancer %K randomized controlled trial %K RCT %K pilot study %K oncology %K mobile health %K mHealth %K quality of life %K eHealth %D 2025 %7 19.2.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Medication nonadherence is a serious problem in cancer, potentially impacts patients’ health outcomes and health care costs. Although technology-based medication adherence (MA) interventions have emerged, evidence supporting their quality and effectiveness remains limited. Objective: This study tested the acceptability, feasibility, and potential effects of Safety and Adherence to Medications and Self-care Advice in Oncology (SAMSON), a digital solution designed to support MA and self-management in cancer. Methods: A 12-week, 2-arm, unblinded, pragmatic pilot randomized controlled trial was conducted. Adults with hematological malignancies who started oral cancer medicines within the last 12 months were recruited from a metropolitan specialized hospital and randomized 1:1 to SAMSON or control (usual care). The SAMSON solution included a smartphone app with tailored alerts and real-time self-care advice, a web-based dashboard for health care professionals (HCPs) to monitor patients’ adherence and symptoms, and motivational interviewing (MI) teleconsultations delivered by oncology nurses and pharmacists at baseline and weeks 1, 4, 8, and 12. Primary outcomes were the patients’ acceptance of SAMSON, measured by the Unified Theory of Acceptance and Use of Technology at 12 weeks, and study feasibility, measured by predefined rates of recruitment, randomization, retention, intervention adherence, and outcome assessment completion. Secondary outcomes were comparison of MA and clinical self-assessments through online questionnaires, including adherence, toxicity self-management, anxiety and depression symptoms, and quality of life, measured at baseline and 12 weeks between the 2 arms. Data retrieved from the SAMSON app (Swinburne University of Technology) was analysed for task completion. Results: A total of 33 patients (79% of those who were approached) consented to participate in the trial. Of those, 31/33 (94%) completed baseline surveys and were randomized to SAMSON (15/31) and control arms (16/31). Of 31 patients, 28 (90%) completed the 12-week surveys (12 SAMSON and 16 control). Overall, patients rated the SAMSON solution as highly acceptable (13/15, 87% app usage; 14/15, 93% MI teleconsultation delivery). They reported that SAMSON was easy to use (10/12, 83%) and helpful in improving their MA (6/12, 50%). All study HCPs reported the SAMSON solution was helpful in supporting patients’ MA. Patients completed an average of 99 tasks over the 12-week study period (71% of scheduled tasks). Most patients (10/12, 83%) completed all 5 scheduled consultations. All study feasibility measures were higher than the predefined upper thresholds, except the rate of patients’ responses to medication reminders. Conclusions: The results demonstrated that the SAMSON solution is acceptable, usable, and useful for oncology HCPs and patients with cancer. The SAMSON solution is feasible in real-life oncology settings. Our next steps involve refining the SAMSON solution based on participants’ feedback, conducting a large-scale randomized controlled trial to evaluate its clinical and economic effectiveness, and exploring potential commercialization. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12623000472673; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385728 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2023-079122 %M 39969972 %R 10.2196/65302 %U https://formative.jmir.org/2025/1/e65302 %U https://doi.org/10.2196/65302 %U http://www.ncbi.nlm.nih.gov/pubmed/39969972 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e59575 %T Continuous Improvement of Chronic Tinnitus Through a 9-Month Smartphone-Based Cognitive Behavioral Therapy: Randomized Controlled Trial %A Walter,Uso %A Pennig,Stefan %A Bleckmann,Lothar %A Röschmann-Doose,Kristina %A Wittig,Thomas %A Thomsen,Jörn %A Schlee,Winfried %+ G Pohl-Boskamp GmbH & Co KG, Kieler Straße 11, Hohenlockstedt, 25551, Germany, 49 4826 59 457, j.thomsen@pohl-boskamp.de %K tinnitus %K chronic tinnitus %K mobile health app %K mHealth %K mobile app %K application %K smartphone %K digital health %K digital technology %K digital intervention %K cognitive behavioral therapy %K randomized controlled trial %K statistical analysis %D 2025 %7 18.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Tinnitus is the perception of sound without an external auditive stimulus and can be a severe burden for affected patients. Medical guidelines recommend cognitive behavioral therapy (CBT) for tinnitus treatment, which effectively improves tinnitus-related distress and anxiety. Objective: This study investigates the outcome of a 9-month smartphone-based CBT for patients with tinnitus. Methods: The randomized controlled clinical trial in this study investigates the efficacy of a smartphone-based CBT for 187 patients with chronic tinnitus over a 9-month treatment period. In the initial 3 months, a waiting list design was applied, and in the subsequent study phase, the data of both treatment groups were collectively analyzed. The scores on the Tinnitus Questionnaire (TQ); 9-item Patient Health Questionnaire (PHQ-9); 9-item Self-Efficacy, Optimism, Pessimism (SWOP-K9) questionnaire; and 20-item Perceived Stress Questionnaire (PSQ-20) were assessed as endpoints after 3 and 9 months of treatment. Results: We observed a statistically significant reduction in the tinnitus burden in patients who received the smartphone-based CBT intervention. Although no changes were observed initially in the TQ sum scores in the waiting control group (baseline mean, 37.8, SD 4.7; 3 months mean 37.5, SD 4.8; analysis of covariance [ANCOVA] P=.52), the scores significantly decreased once the app-based CBT had commenced. Data pooled from both groups revealed significant reduction in the TQ sum score by 12.49 (SD 1.44) (ANCOVA, P<.001) and 18.48 (SD 1.85) (ANCOVA, P<.001) points after 3 and 9 months, respectively, which was also clinically important. The calculated Cohen d was 1.38. Similarly, the scores on PSQ-20 (–9.14 points; ANCOVA, P<.001), PHQ-9 (–2.47 points; ANCOVA, P<.001), and SWOP-K9 (0.17 points; ANCOVA, P<.001) were significantly improved at the end of the therapy, with corresponding intermediate effect sizes after 9 months. Conclusions: The data in our study provide evidence of statistically significant, clinically relevant, and continuous benefits of an app-based CBT intervention in patients with chronic tinnitus. Trial Registration: Deutsches Register Klinischer Studien DRKS00022973; https://drks.de/search/de/trial/DRKS00022973 %M 39965780 %R 10.2196/59575 %U https://www.jmir.org/2025/1/e59575 %U https://doi.org/10.2196/59575 %U http://www.ncbi.nlm.nih.gov/pubmed/39965780 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e64017 %T Mental Health Changes in US Transgender Adults Beginning Hormone Therapy Via Telehealth: Longitudinal Cohort Study %A Corman,Jae Downing %A Hughto,Jaclyn M W %A Shireman,Theresa I %A Baker,Kellan %A Steinle,Kate %A Forcier,Michelle %+ FOLX Health, 1 Boston Pl, Ste 2600, Boston, MA, 02108, United States, 1 617 792 6855, jae@folxhealth.com %K transgender %K LGBT persons %K telehealth %K depression %K anxiety %K suicide %K mental health %K adult %K virtual care %K longitudinal cohort study %K gender-affirming hormone therapy %K United States %K observational study %K adolescent %K mobile health %D 2025 %7 14.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Gender-affirming hormone therapy (GAHT) has shown potential for improving mental health outcomes among transgender and gender-diverse adults. How clinical outcomes change among adults receiving GAHT via telehealth across the United States is not well known. Objective: This study evaluated the relationship between initiating GAHT via a telehealth clinic and changes in depression, anxiety, and suicide ideation over a 3-month period. Methods: This cohort study evaluated the relationship between initiating GAHT via a telehealth clinic and changes in mental health over a 3-month period. Data were collected at baseline and 3 months later among adults who had their first GAHT visit between August and November 2023. The study included adults aged 18 years and older initiating GAHT for the first time, with a final sample of 342 adults across 43 states (192 initiated estrogen and 150 initiated testosterone therapy). The primary outcomes were depression symptoms using the Patient Health Questionnaire-9 (PHQ-9), anxiety symptoms using the General Anxiety Disorder-7 (GAD-7), and suicide ideation in the past 2 weeks. Results: Before GAHT initiation, 40% (136/342) of participants reported depression (PHQ-9 ≥10), 36% (120/342) reported anxiety (GAD-7 ≥8), and 25% (91/342) reported suicidal ideation. By follow-up, significant reductions were observed in PHQ-9 (−2.4, 95% CI −3.0 to −1.8) and GAD-7 scores (−1.5, 95% CI −2.0 to −1.0). Among those with elevated symptoms, 40% (48/120) to 42% (56/133) achieved a clinically meaningful response (≥50% reduction in baseline scores), and 27% (36/133) to 28% (33/120) achieved remission (PHQ-9 or GAD-7 score <5). Of those with suicide ideation at baseline, 60% (50/83) had none at follow-up. Conclusions: This study highlights the important relationship between telehealth-delivered GAHT and mental health, emphasizing the importance of accessible and timely care. %M 39951700 %R 10.2196/64017 %U https://www.jmir.org/2025/1/e64017 %U https://doi.org/10.2196/64017 %U http://www.ncbi.nlm.nih.gov/pubmed/39951700 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e63209 %T Assessing the Effectiveness of Digital Health Behavior Strategies on Type 2 Diabetes Management: Systematic Review and Network Meta-Analysis %A Li,Min %A Liu,Shiyu %A Yu,Binyang %A Li,Ning %A Lyu,Aili %A Yang,Haiyan %A He,Haiyan %A Zhang,Na %A Ma,Jingru %A Sun,Meichen %A Du,Hong %A Gao,Rui %+ School of Nursing, Health Science Center, Xi 'an Jiaotong University, 74 Yanta West Road, Xi 'an, 710061, China, 86 18966606582, gaorui@xjtu.edu.cn %K T2DM %K type 2 diabetes mellitus %K digital health interventions %K behavior strategy %K strategy combinations %K effectiveness %K network meta-analysis %D 2025 %7 14.2.2025 %9 Review %J J Med Internet Res %G English %X Background: Various mobile technologies and digital health interventions (DHIs) have been developed for type 2 diabetes mellitus (T2DM) management. Strategies are crucial for ensuring the effectiveness of DHIs. However, there is currently a lack of categorization and summarization of the strategies used in DHIs for T2DM. Objective: This study aims to (1) identify and categorize the strategies used in DHIs for T2DM management; (2) assess the effectiveness of these DHI strategies; and (3) compare and rank the efficacy of different strategy combinations on glycated hemoglobin A1c (HbA1c) levels, fasting blood glucose (FBG) levels, BMI, and weight loss. Methods: Relevant randomized controlled trials (RCTs) were extracted from PubMed, Web of Science, and Scopus databases. Three rounds of screening and selection were conducted. The strategies were identified and categorized based on the principles of behavior change techniques and behavior strategies. The synthesis framework for the assessment of health IT was used to structure the evaluation of the DHI strategies qualitatively. A network meta-analysis was performed to compare the efficacy of different strategy combinations. The data quality was assessed using the Cochrane Risk of Bias tool. Results: A total of 52 RCTs were included, identifying 63 strategies categorized into 19 strategy themes. The most commonly used strategies were guide, monitor, management, and engagement. Most studies reported positive or mixed outcomes for most indicators based on the synthesis framework for the assessment of health IT. Research involving a medium or high number of strategies was found to be more effective than research involving a low number of strategies. Of 52 RCTs, 27 (52%) were included in the network meta-analysis. The strategy combination of communication, engagement, guide, and management was most effective in reducing HbA1c levels (mean difference [MD] –1.04, 95% CI –1.55 to –0.54), while the strategy combination of guide, management, and monitor was effective in reducing FBG levels (MD –0.96, 95% CI –1.86 to –0.06). The strategy combination of communication, engagement, goal setting, management, and support was most effective for BMI (MD –2.30, 95% CI –3.16 to –1.44) and weight management (MD –6.50, 95% CI –8.82 to –4.18). Conclusions: Several DHI strategy combinations were effective in reducing HbA1c levels, FBG levels, BMI, and weight in T2DM management. Health care professionals should be encouraged to apply these promising strategy combinations in DHIs during clinical care. Future research should further explore and optimize the design and implementation of strategies. Trial Registration: PROSPERO CRD42024544629; https://tinyurl.com/3zp2znxt %M 39951722 %R 10.2196/63209 %U https://www.jmir.org/2025/1/e63209 %U https://doi.org/10.2196/63209 %U http://www.ncbi.nlm.nih.gov/pubmed/39951722 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 12 %N %P e68251 %T Telehealth-Based vs In-Person Aerobic Exercise in Individuals With Schizophrenia: Comparative Analysis of Feasibility, Safety, and Efficacy %A Kimhy,David %A Ospina,Luz H %A Wall,Melanie %A Alschuler,Daniel M %A Jarskog,Lars F %A Ballon,Jacob S %A McEvoy,Joseph %A Bartels,Matthew N %A Buchsbaum,Richard %A Goodman,Marianne %A Miller,Sloane A %A Stroup,T Scott %K schizophrenia %K psychosis %K exercise %K aerobic fitness %K VO2max %K telehealth %K telemedicine %K COVID-19 %K clinical trial %K safety %K maximum oxygen consumption %D 2025 %7 14.2.2025 %9 %J JMIR Ment Health %G English %X Background: Aerobic exercise (AE) training has been shown to enhance aerobic fitness in people with schizophrenia. Traditionally, such training has been administered in person at gyms or other communal exercise spaces. However, following the advent of the COVID-19 pandemic, many clinics transitioned their services to telehealth-based delivery. Yet, at present, there is scarce information about the feasibility, safety, and efficacy of telehealth-based AE in this population. Objective: To examine the feasibility, safety, and efficacy of trainer-led, at-home, telehealth-based AE in individuals with schizophrenia. Methods: We analyzed data from the AE arm (n=37) of a single-blind, randomized clinical trial examining the impact of a 12-week AE intervention in people with schizophrenia. Following the onset of the COVID-19 pandemic, the AE trial intervention transitioned from in-person to at-home, telehealth-based delivery of AE, with the training frequency and duration remaining identical. We compared the feasibility, safety, and efficacy of the delivery of trainer-led AE training among participants undergoing in-person (pre–COVID-19; n=23) versus at-home telehealth AE (post–COVID-19; n=14). Results: The telehealth and in-person participants attended a similar number of exercise sessions across the 12-week interventions (26.8, SD 10.2 vs 26.1, SD 9.7, respectively; P=.84) and had similar number of weeks with at least 1 exercise session (10.4, SD 3.4 vs 10.6, SD 3.1, respectively; P=.79). The telehealth-based AE was associated with a significantly lower drop-out rate (telehealth: 0/14, 0%; in-person: 7/23, 30.4%; P=.04). There were no significant group differences in total time spent exercising (telehealth: 1246, SD 686 min; in-person: 1494, SD 580 min; P=.28); however, over the 12-week intervention, the telehealth group had a significantly lower proportion of session-time exercising at or above target intensity (telehealth: 33.3%, SD 21.4%; in-person: 63.5%, SD 16.3%; P<.001). There were no AE-related serious adverse events associated with either AE delivery format. Similarly, there were no significant differences in the percentage of participants experiencing minor or moderate adverse events, such as muscle soreness, joint pain, blisters, or dyspnea (telehealth: 3/14, 21%; in-person: 5/19, 26%; P>.99) or in the percentage of weeks per participant with at least 1 exercise-related adverse event (telehealth: 31%, SD 33%; in-person: 40%, SD 33%; P=.44). There were no significant differences between the telehealth versus in-person groups regarding changes in aerobic fitness as indexed by maximum oxygen consumption (VO2max; P=.27). Conclusions: Our findings provide preliminary support for the delivery of telehealth-based AE for individuals with schizophrenia. Our results indicate that in-home telehealth-based AE is feasible and safe in this population, although when available, in-person AE appears preferable given the opportunity for social interactions and the higher intensity of exercises. We discuss the findings’ clinical implications, specifically within the context of the COVID-19 pandemic, as well as review potential challenges for the implementation of telehealth-based AE among people with schizophrenia. %R 10.2196/68251 %U https://mental.jmir.org/2025/1/e68251 %U https://doi.org/10.2196/68251 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e60256 %T Effects of Individualized Follow-Up With an App Postcardiac Rehabilitation: Five-Year Follow-Up of a Randomized Controlled Trial %A Lunde,Pernille %A Bye,Asta %A Grimsmo,Jostein %A Pripp,Are Hugo %A Ritschel,Vibeke %A Jarstad,Even %A Nilsson,Birgitta Blakstad %+ Department of Rehabilitation Science and Health Technology, Faculty of Health Sciences, OsloMet – Oslo Metropolitan University, PB 4, St. Olavs plass, Oslo, 0130, Norway, 47 48063537, plunde@oslomet.no %K mHealth %K cardiac rehabilitation %K mobile phone app %K smartphone %K lifestyle %D 2025 %7 13.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Adherence to healthy behaviors initiated or adapted during cardiac rehabilitation (CR) remains a significant challenge, with few patients meeting guideline standards for secondary prevention. The use of mobile health (mHealth) interventions has been proposed as a potential solution to improve adherence to healthy behaviors after CR. In particular, app-based interventions have shown promise due to their ability to provide monitoring and feedback anytime and anywhere. Growing evidence supports the use of apps in post-CR settings to enhance adherence. In 2020, we demonstrated that individualized follow-up via an app increased adherence to healthy behaviors 1 year after CR. However, it remains uncertain whether these effects persist once the follow-up is discontinued. Objective: This study aims to evaluate the long-term effects of individualized follow-up using an app, assessed 4 years after the intervention. Methods: A single-blinded multicenter randomized controlled trial was conducted. Patients were recruited from 2 CR centers in eastern Norway. The intervention group (IG) received individualized follow-up through an app for 1 year, while the control group (CG) received usual care. After the 1-year follow-up, the app-based follow-up was discontinued for the IG, and both groups were encouraged to maintain or improve their healthy behaviors based on their individual risk profiles. The primary outcome was the difference in peak oxygen uptake (VO2peak). The secondary outcomes included exercise performance, body weight, blood pressure, lipid profile, exercise habits, health-related quality of life, health status, cardiac events, and physical activity. Linear mixed models for repeated measurements were used to analyze differences between groups. All tests were 2-sided, and P values ≤0.05 were considered statistically significant. Results: At the 5-year follow-up, 101 out of the initial 113 randomized participants were reassessed. Intention-to-treat analyses, using a mixed model for repeated measurements, revealed a statistically significant difference (P=.04) in exercise habits in favor of the IG, with a mean difference of 0.67 (95% CI 0.04-1.29) exercise sessions per week. Statistically significant differences were also observed in triglycerides (mean difference 0.40, 95% CI 0.00-0.79 mmol/l, P=.048) and walking (P=.03), but these were in favor of the CG. No differences were found between the groups for other evaluated outcomes. Conclusions: Most of the benefits derived from the app-based follow-up diminished by 4 years after the intervention. Although the IG reported statistically significantly higher levels of exercise, this did not translate into improved VO2peak or exercise performance. Our study highlights the need for follow-up from health care providers to enhance adherence to healthy behaviors in the long term following CR. Trial Registration: ClinicalTrials.gov NCT03174106; https://clinicaltrials.gov/ct2/show/NCT03174106 (original study protocol) and NCT05697120; https://clinicaltrials.gov/ct2/show/NCT05697120 (updated study protocol) %M 39946716 %R 10.2196/60256 %U https://www.jmir.org/2025/1/e60256 %U https://doi.org/10.2196/60256 %U http://www.ncbi.nlm.nih.gov/pubmed/39946716 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e55583 %T Effectiveness of an Internet-Based, Self-Guided, Short-Term Mindfulness Training (ISSMT) Program for Relieving Depressive Symptoms in the Adult Population in China: Single-Blind, Randomized Controlled Trial %A Zhu,Tingfei %A Zhang,Liuyi %A Weng,Wenqi %A Gan,Ruochen %A Sun,Limin %A Wei,Yanping %A Zhu,Yueping %A Yu,Hongyan %A Xue,Jiang %A Chen,Shulin %+ Department of Psychology and Behavioral Sciences, Zhejiang University, No.148 Tianmushan Road, Hangzhou, China, 86 18958001648, chenshulin@zju.edu.cn %K internet-based %K self-guided %K short-term %K mindfulness %K depression %K randomized controlled trial %D 2025 %7 13.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression is a significant global public health issue, and in China, access to mental health services remains limited despite high demand. Research has shown that mindfulness can effectively alleviate depressive symptoms and that telehealth solutions offer a promising avenue for addressing this service gap. Despite this potential, there are currently few studies in China focusing on short-term online mindfulness training. Most existing online mindfulness studies relied on traditional 8-week programs, which can be challenging for participant adherence due to limited accessibility and high dropout rates. Additionally, limited research exists on short-term online mindfulness interventions, and findings remain inconsistent. Objective: This study aimed to develop and evaluate an internet-based, self-guided, short-term mindfulness training (ISSMT) program based on the Monitor and Acceptance Theory (MAT) to reduce depression symptoms. Methods: The ISSMT program was delivered via an online platform, “Hi Emotion,” and was accessible to the general public. Interested individuals aged 18 years and older were randomized into either the ISSMT group or a wait-list control group. Participants in the ISSMT group received daily reminders to participate in a 15- to 20-minute session over a 14-day training period. Measurements, including mindfulness and depressive symptoms, were collected at baseline and weekly for the subsequent 3 weeks. Results: A total of 205 adults participated in the 14-day online intervention. Linear mixed models were used to analyze both per-protocol (PP) and intention-to-treat (ITT) samples. Compared with the wait-list control group, participants in the ISSMT group showed significant improvements in mindfulness (Cohen d=0.44 for ITT; Cohen d=0.55 for PP) and reductions in depressive symptoms (Cohen d=0.50 for ITT; Cohen d=0.53 for PP). Furthermore, participants expressed high acceptance of this training format with a relatively low dropout rate (<40%). Conclusions: The ISSMT program based on the MAT effectively enhanced mindfulness and alleviated depressive symptoms. This intervention could be considered for integration into psychosocial service systems to improve mental health outcomes and help bridge the gap between limited resources and the high demand for services in China. Future research should focus on personalizing these programs and incorporating advanced technologies to enhance their effectiveness and user engagement. Trial Registration: Open Science Framework; https://doi.org/10.17605/OSF.IO/8P4V6 %M 39946708 %R 10.2196/55583 %U https://www.jmir.org/2025/1/e55583 %U https://doi.org/10.2196/55583 %U http://www.ncbi.nlm.nih.gov/pubmed/39946708 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e63166 %T Smartphone Application–Based Voice and Speech Training Program for Parkinson Disease: Feasibility and Satisfaction Study With a Preliminary Rater-Blinded Single-Arm Pretest and Posttest Design %A Lee,Sol-Hee %A Kim,Jiae %A Kim,Han-Joon %+ Department of Neurology, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea, 82 10 7279 7883, movement@snu.ac.kr %K Parkinson disease %K speech therapy %K mHealth %K home-based training %K self-delivered %K digital health care %K app %K feasibility %K voice therapy %K mobile phone %K satisfaction %K effectiveness %K smartphone %K apps %K single-arm study %K mobility %K mobile health %K acoustic analysis %K self-training %D 2025 %7 13.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Up to 75% of patients with Parkinson disease (PD) experience voice and speech impairments, such as breathy phonation and low speech volume, which worsen over time and negatively impact the quality of life. However, given their increasingly limited mobility, face-to-face speech therapy is often inaccessible. Mobile health (mHealth) apps offer accessible and cost-effective alternatives; yet, their application in PD-specific, self-delivered voice therapy remains underexplored. Objective: This study aimed to evaluate the feasibility, adherence, and satisfaction of a self-delivered smartphone app for voice therapy in patients with PD, designed to minimize speech-language pathologist involvement while promoting patient independence. In addition, it seeks to assess the preliminary therapeutic effectiveness of the app in addressing voice and speech problems in this population. Methods: A single-arm, rater-blinded, and pretest and posttest study was conducted between September to November 2023. Patients with PD with voice and speech problems who have no problem with using Android (Google) smartphones were recruited. Participants downloaded the researcher-developed mHealth app on their smartphone and participated in a patient-tailored 5-week home-based speech training program. Each session included 5 stages: breathing, oral motor exercises, loudness, prosody, and functional speaking. The training program consisted of 20 sessions, with participants completing 1 session per day, 4 days per week. Each session lasted approximately 20-30 minutes. Adherence was monitored through app logs, satisfaction was assessed through a phone survey, and therapeutic effectiveness was evaluated using acoustic analysis and auditory-perceptual assessments. Results: Out of 30 patients were initially recruited, but 2 of them withdrew. Out of 25 participants completed all the training sessions while 3 dropped out. The adherence was above 90% in 20 participants (80%, 20/25), 70% to 90% in 4 (16%, 4/25), and below 70% in 4 (16%, 4/25). Satisfaction was 75% (18/24) among the 24 people who participated in the survey. Significant improvements were observed in all acoustic measures: the maximum phonation time increased from 11.15 (SD 5.38) seconds to 14.01 (SD 5.64) seconds (P=.003), and vocal intensity increased from 71.59 (SD 4.39) dB to 73.81 (SD 3.48) dB (P<.001) across both sustained phonation and reading tasks. Voice quality scores on the GRBAS (grade, roughness, breathiness, asthenia, and strain) scale improved significantly (all components P<.001). Furthermore, 58.3% (14/24) of participants reported subjective improvements in their voice. Conclusions: This study demonstrates that home-based, self-training speech therapy delivered through a mHealth app is a feasible solution for patients with PD, suggesting that mHealth apps can serve as a convenient and effective alternative to face-to-face therapy by enhancing accessibility and empowering patients to actively manage their condition. %M 39946689 %R 10.2196/63166 %U https://www.jmir.org/2025/1/e63166 %U https://doi.org/10.2196/63166 %U http://www.ncbi.nlm.nih.gov/pubmed/39946689 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 11 %N %P e60158 %T Challenges of Cross-Sectoral Video Consultation in Cancer Care on Patients’ Perceived Coordination: Randomized Controlled Trial %A Baygi,Fereshteh %A Bitz Trabjerg,Theis %A Jensen,Lars Henrik %A Munch Storsveen,Maria %A Wehberg,Sonja %A Sisler,Jeffrey James %A Søndergaard,Jens %A Gilså Hansen,Dorte %K randomized controlled trials %K video consultations %K outcome assessment %K patients’ satisfaction %K patients’ care coordination %K interprofessional relations %K cancer %D 2025 %7 11.2.2025 %9 %J JMIR Cancer %G English %X Background: Patients with cancer need coordinated care for both treatment and concurrent health conditions. This requires collaboration among specialists when using telemedicine services, emphasizing the importance of care continuity. Objective: This study aimed to explore the effects of cross-sectorial video consultation involving oncologists, general practitioners, and patients with cancer on patients’ perceived coordination of care, compared with usual care. Methods: This study describes the primary outcomes from a 7-month follow-up of patients in the Partnership Project, a randomized clinical trial. Patients in the intervention group were randomized to receive a “partnership consultation,” a shared video consultation with an oncologist, general practitioners, and the patient, in addition to their usual care. Questionnaires were completed for both groups at baseline and 7 months to assess the primary outcome, “global assessment of inter-sectorial cooperation,” from the Danish questionnaire “Patients’ attitude to the health care service.” The questionnaire also included 2 single items and 5 index scales, examining patients’ attitude toward cooperation in the health care system. Change in perceived global coordination from baseline to 7 months was compared between intention-to-treat groups using generalized estimating equations in a linear regression model. Results: A total of 278 participants were randomized with 1:1 allocation, with 80 patients receiving the intervention. Further, 210 patients completed the questionnaire at baseline, while 118 responded at 7-month follow-up. The estimated difference in the primary outcome between usual care (−0.13, 95% CI −0.38 to 0.12) and intervention (0.11, 95% CI −0.11 to 0.34) was 0.24 (95% CI −0.09 to 0.58) and not statistically significant (P=.15). Conclusions: Low rates of intervention completion and high levels of missing data compromised the interpretability of our study. While we observed a high level of global assessment of coordination, the estimated intervention effect was smaller than anticipated, with no significant difference in perceived coordination between control and intervention groups. Future studies should explore strategies like patient incentives to increase response rate and improve the evaluation of this innovative health care model. Trial Registration: ClinicalTrials.gov NCT02716168; https://clinicaltrials.gov/study/NCT02716168 International Registered Report Identifier (IRRID): RR2-10.1186/s12875-019-0978-8 %R 10.2196/60158 %U https://cancer.jmir.org/2025/1/e60158 %U https://doi.org/10.2196/60158 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e59656 %T Interventions for Digital Addiction: Umbrella Review of Meta-Analyses %A Lu,Peng %A Qiu,Jiamin %A Huang,Shiqi %A Wang,Xinman %A Han,Shasha %A Zhu,Sui %A Ning,Youjing %A Zeng,Fang-fang %A Yuan,Yuan %+ Department of Chinese International Education, Chinese Language and Culture College, Huaqiao University, No 8 Jiageng Road, Xiamen, 361021, China, 86 6068002, yuanyuan361021@163.com %K digital addiction %K interventions %K umbrella reviews %K systematic review %K internet addiction %K loneliness %K quality of life %K well-being %K internet %K psychological %K pharmacological treatment %K cognitive behavioral therapy %D 2025 %7 11.2.2025 %9 Review %J J Med Internet Res %G English %X Background: Numerous studies have explored interventions to reduce digital addiction outcomes, but inconclusive evidence makes it difficult for decision-makers, managers, and clinicians to become familiar with all available literature and find appropriate interventions. Objective: This study aims to summarize and assess the certainty of evidence of interventions proposed to decrease digital addiction from published meta-analyses. Methods: An umbrella review of published meta-analyses was performed. We searched PubMed, Cochrane Library, Web of Science, and Embase for meta-analyses published up to February 2024. Eligible studies evaluated interventions using randomized controlled trials, nonrandomized controlled trials, or quasi-experimental studies and were assessed for methodological quality using Assessment of Multiple Systematic Reviews version 2. A random effects model was used to analyze data, considering heterogeneity and publication bias. Grading of Recommendations, Assessment, Development, and Evaluations was applied to assess evidence with certainty. Results: A total of 5 studies assessing 21 associations were included in the umbrella review, of which 4 (80%) were high-quality meta-analyses. Weak evidence was observed in 19 associations, whereas null associations appeared in the remaining 2 associations. These associations pertained to 8 interventions (group counseling, integrated internet addiction [IA] prevention programs, psychosocial interventions, reality therapy, self-control training programs, cognitive behavioral therapy, interventions to reduce screen time in children, and exercise) and 9 outcomes (self-control, self-esteem, internet gaming disorder symptoms, time spent gaming, IA scores, screen use time, interpersonal sensitivity longlines, anxiety, and depression). Cognitive behavioral therapy reduces anxiety (standardized mean difference [SMD] 0.939, 95% CI 0.311 to 1.586), internet gaming disorder symptoms (SMD 1.394, 95% CI 0.664 to 2.214), time spent gaming (SMD 1.259, 95% CI, 0.311 to 2.206), and IA scores (SMD –2.097, 95% CI –2.814 to –1.381). Group counseling had a large effect on improving self-control (SMD 1.296, 95% CI 0.269 to 2.322) and reducing IA levels (SMD –1.417, 95% CI –1.836 to –0.997). Exercise intervention reduced IA scores (SMD –2.322, 95% CI –3.212 to –1.431), depression scores (SMD –1.421, 95% CI –2.046 to –797), and interpersonal sensitivity scores (SMD –1.433, 95% CI –2.239 to –0.627). Conclusions: The evidence indicates that current interventions to reduce digital addiction are weak. Data from more and better-designed studies with larger sample sizes are needed to establish robust evidence. Trial Registration: PROSPERO CRD42024528173; crd.york.ac.uk/PROSPERO/display_record.php?RecordID=528173 %M 39933164 %R 10.2196/59656 %U https://www.jmir.org/2025/1/e59656 %U https://doi.org/10.2196/59656 %U http://www.ncbi.nlm.nih.gov/pubmed/39933164 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 13 %N %P e60755 %T Evaluating the Efficacy of a Serious Game to Deliver Health Education About Invasive Meningococcal Disease: Clustered Randomized Controlled Equivalence Trial %A Bloomfield,Lauren %A Boston,Julie %A Masek,Martin %A Andrew,Lesley %A Barwood,Donna %A Devine,Amanda %+ Edith Cowan University, 270 Joondalup Drive, Joondalup, 6027, Australia, 61 0863045702, julie.boston@ecu.edu.au %K serious games %K meningococcal disease %K immersive digital applications %K health promotion %K gaming %K meningitis %K infection %K bacteria %K contagious %K infectious %K immersive %K education %K mHealth %K mobile health %K applications %K youth %K adolescents %D 2025 %7 11.2.2025 %9 Original Paper %J JMIR Serious Games %G English %X Background: Invasive meningococcal disease (IMD) is a serious, vaccine-preventable infectious disease that can be life-threatening. Teaching adolescents about the early detection and prevention of IMD can be challenging in a school environment, with educators reporting they lack confidence or expertise to cover this in the classroom environment. Professional guest educators are an alternative to cover specialist topics such as IMD; however, time and resourcing constraints can mean that these educators are not always available. Serious games may be an alternative to face-to-face education, where complex health information may be delivered via self-directed gameplay. Objective: This study aims to develop a serious game that can replace a face-to-face educator in a classroom setting to educate adolescents aged 12 years to 15 years. This study evaluates the efficacy of the Meningococcal Immunisation Awareness, Prevention and Protection app (MIApp), a serious game designed to replicate the information provided in a 30-minute face-to-face presentation provided by a trained educator. Methods: This clustered, randomized controlled equivalence trial involved students (Years 7-10) from 6 secondary schools across metropolitan Western Australia who completed pre- and postintervention questionnaires with a follow-up at 3 months postintervention to measure the primary outcome of IMD knowledge acquisition following this self-guided intervention. The findings were compared with changes in an active control (comparison) group who received an in-class educational presentation about IMD transmission and protection. A questionnaire was developed to assess 9 key areas of knowledge. Median scores for knowledge pre- and postintervention were collected from a self-administered assessment of this questionnaire and, at 3 months postintervention, were compared between groups. A knowledge score of +/–2/16 was determined a priori to meet the criteria for equivalence. Participants who used MIApp were also asked a series of questions to assess the enjoyment of and engagement with the game. Results: Of the 788 participating students, the median postintervention correct score in both the MIApp and control cohorts was 14/16 (87.5% correct responses), compared with the median pre-intervention correct score of 6/16 (37.5% correct responses), representing a significant (P<.001) increase in IMD knowledge in both groups. Improvements were retained in both groups 3 months after the initial intervention (median correct score: 11/16 in the intervention group; 12/16 in the control group; P=.86), demonstrating the efficacy of MIApp to deliver health education about IMD transmission and protection, although response rates in the follow-up cohort were low (255/788, 32.4%). Conclusions: MIApp met the predetermined threshold for equivalence, demonstrating similar improvements in knowledge posttrial and at the 3-month follow-up. Participating adolescents considered the MIApp game more enjoyable than a presentation, with equivalent improvements in knowledge. Serious games could represent a constructive tool to help teachers impart specialized health education. %M 39932769 %R 10.2196/60755 %U https://games.jmir.org/2025/1/e60755 %U https://doi.org/10.2196/60755 %U http://www.ncbi.nlm.nih.gov/pubmed/39932769 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 12 %N %P e63149 %T Harnessing Internet Search Data as a Potential Tool for Medical Diagnosis: Literature Review %A Downing,Gregory J %A Tramontozzi,Lucas M %A Garcia,Jackson %A Villanueva,Emma %+ Innovation Horizons, Inc, 2819 27th Street, NW, Washington, DC, 20008, United States, 1 (301) 675 1346, gregory.downing@innovationhorizons.net %K health %K informatics %K internet search data %K early diagnosis %K web search %K information technology %K internet %K machine learning %K medical records %K diagnosis %K health care %K self-diagnosis %K detection %K intervention %K patient education %K internet search %K health-seeking behavior %K artificial intelligence %K AI %D 2025 %7 11.2.2025 %9 Review %J JMIR Ment Health %G English %X Background: The integration of information technology into health care has created opportunities to address diagnostic challenges. Internet searches, representing a vast source of health-related data, hold promise for improving early disease detection. Studies suggest that patterns in search behavior can reveal symptoms before clinical diagnosis, offering potential for innovative diagnostic tools. Leveraging advancements in machine learning, researchers have explored linking search data with health records to enhance screening and outcomes. However, challenges like privacy, bias, and scalability remain critical to its widespread adoption. Objective: We aimed to explore the potential and challenges of using internet search data in medical diagnosis, with a specific focus on diseases and conditions such as cancer, cardiovascular disease, mental and behavioral health, neurodegenerative disorders, and nutritional and metabolic diseases. We examined ethical, technical, and policy considerations while assessing the current state of research, identifying gaps and limitations, and proposing future research directions to advance this emerging field. Methods: We conducted a comprehensive analysis of peer-reviewed literature and informational interviews with subject matter experts to examine the landscape of internet search data use in medical research. We searched for published peer-reviewed literature on the PubMed database between October and December 2023. Results: Systematic selection based on predefined criteria included 40 articles from the 2499 identified articles. The analysis revealed a nascent domain of internet search data research in medical diagnosis, marked by advancements in analytics and data integration. Despite challenges such as bias, privacy, and infrastructure limitations, emerging initiatives could reshape data collection and privacy safeguards. Conclusions: We identified signals correlating with diagnostic considerations in certain diseases and conditions, indicating the potential for such data to enhance clinical diagnostic capabilities. However, leveraging internet search data for improved early diagnosis and health care outcomes requires effectively addressing ethical, technical, and policy challenges. By fostering interdisciplinary collaboration, advancing infrastructure development, and prioritizing patient engagement and consent, researchers can unlock the transformative potential of internet search data in medical diagnosis to ultimately enhance patient care and advance health care practice and policy. %M 39813106 %R 10.2196/63149 %U https://mental.jmir.org/2025/1/e63149 %U https://doi.org/10.2196/63149 %U http://www.ncbi.nlm.nih.gov/pubmed/39813106 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e60495 %T mHealth App to Promote Healthy Lifestyles for Diverse Families Living in Rural Areas: Usability Study %A Perez Ramirez,Alejandra %A Ortega,Adrian %A Stephenson,Natalie %A Muñoz Osorio,Angel %A Kazak,Anne %A Phan,Thao-Ly %+ Center For Healthcare Delivery Science, Nemours Children's Health, 1600 Rockland Road, Wilmington, DE, 19803, United States, 1 302 358 5968, alejandra.perezramirez@nemours.org %K obesity %K user testing %K mHealth %K mobile health %K Spanish %K child %K rural population %D 2025 %7 11.2.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Mobile Integrated Care for Childhood Obesity is a multicomponent intervention for caregivers of young children with obesity from rural communities that was developed in collaboration with community, parent, and health care partners. It includes community programming to promote healthy lifestyles and address social needs and health care visits with an interdisciplinary team. A digital mobile health platform—the Healthy Lifestyle (Nemours Children’s Health) dashboard—was designed as a self-management tool for caregivers to use as part of Mobile Integrated Care for Childhood Obesity. Objective: This study aimed to improve the usability of the English and Spanish language versions of the Healthy Lifestyle dashboard. Methods: During a 3-phased approach, usability testing was conducted with a diverse group of parents. In total, 7 mothers of children with obesity from rural communities (average age 39, SD 4.9 years; 4 Spanish-speaking and 3 English-speaking) provided feedback on a prototype of the dashboard. Participants verbalized their thoughts while using the prototype to complete 4 tasks. Preferences on the dashboard icon and resource page layout were also collected. Testing was done until feedback reached saturation and no additional substantive changes were suggested. Qualitative and quantitative data regarding usability, acceptability, and understandability were analyzed. Results: The dashboard was noted to be acceptable by 100% (N=7) of the participants. Overall, participants found the dashboard easy to navigate and found the resources, notifications, and ability to communicate with the health care team to be especially helpful. However, all (N=4) of the Spanish-speaking participants identified challenges related to numeracy (eg, difficulty interpreting the growth chart) and literacy (eg, features not fully available in Spanish), which informed iterative refinements to make the dashboard clearer and more literacy-sensitive. All 7 participants (100%) selected the same dashboard icon and 71% (5/7) preferred the final resource page layout. Conclusions: Conducting usability testing with key demographic populations, especially Spanish-speaking populations, was important to developing a mobile health intervention that is user-friendly, culturally relevant, and literacy-sensitive. %M 39932772 %R 10.2196/60495 %U https://formative.jmir.org/2025/1/e60495 %U https://doi.org/10.2196/60495 %U http://www.ncbi.nlm.nih.gov/pubmed/39932772 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e58917 %T Just-In-Time Adaptive Interventions to Promote Behavioral Health: Protocol for a Systematic Review %A Henry,Lauren M %A Blay-Tofey,Morkeh %A Haeffner,Clara E %A Raymond,Cassandra N %A Tandilashvili,Elizabeth %A Terry,Nancy %A Kiderman,Miryam %A Metcalf,Olivia %A Brotman,Melissa A %A Lopez-Guzman,Silvia %+ Emotion and Development Branch, National Institute of Mental Health, 9000 Rockville Pike, Building 15K, Bethesda, MD, 20892, United States, 1 301 480 3895, lauren.henry@nih.gov %K just-in-time adaptive interventions %K JITAI %K behavioral health %K systematic review %K behavior change %K health outcomes %K accessibility %K digital treatment delivery %K mobile phone %D 2025 %7 11.2.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: The goal of just-in-time adaptive interventions (JITAIs) is to use mobile, digital tools to provide individuals with personalized interventions at the optimal time and in the optimal context. Accordingly, JITAIs are promising for advancing accessible, equitable, and evidence-based treatment for behavioral health. To guide future inquiry in this space, a review of the literature is needed to describe the state of research on JITAIs for behavioral health. Objective: This study aims to systematically review the literature to describe the landscape of existing JITAIs for behavioral health at any stage of intervention development. In addition, conditional upon a sufficiently homogeneous literature, we will conduct meta-analyses to investigate the effectiveness of JITAIs for promoting distal outcomes (here, aspects of behavioral health) and proximal outcomes (eg, emotion regulation). Methods: This systematic review is being conducted in accordance with the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols). We developed our search strategy and executed the literature search in collaboration with biomedical librarians; 5 databases (PubMed, Embase, Cochrane Library, Web of Science: Core Collection, and APA PsycINFO) were searched, and results were managed using EndNote 20 (Clarivate). We are screening (title, abstract, and full text) all records in duplicate in Covidence according to eligibility criteria. Data items will be extracted, and risk of bias will be assessed in duplicate from the included articles in Covidence. We will summarize JITAI characteristics in tables and text. We will conduct meta-analyses for the distal and proximal outcomes conditional upon sufficient homogeneity in subgroups. Moderation (conditional upon sufficient heterogeneity of outcomes) and mediation (ie, whether changes in proximal outcomes mediate the relation between JITAIs and distal outcomes) will be conducted as appropriate. We will investigate publication bias and use the Grading of Recommendations Assessment, Development and Evaluation to characterize the quality of evidence of our estimates. Results: The search strategy was developed between July 2023 and November 2023. The literature search was executed between November 2023 and December 2023. Title and abstract screening began in December 2023, and full-text screening began in May 2024. Data extraction and analyses have not begun. Conclusions: Here, we propose a systematic review to assess the state of the literature on JITAIs for behavioral health. The insights derived from this study will describe the literature on JITAIs in promoting behavioral health, reinforce JITAI definitions, clarify JITAI elements, and inform the next steps in JITAI research. International Registered Report Identifier (IRRID): PRR1-10.2196/58917 %M 39932763 %R 10.2196/58917 %U https://www.researchprotocols.org/2025/1/e58917 %U https://doi.org/10.2196/58917 %U http://www.ncbi.nlm.nih.gov/pubmed/39932763 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 11 %N %P e64747 %T An App-Based Intervention With Behavioral Support to Promote Brisk Walking in People Diagnosed With Breast, Prostate, or Colorectal Cancer (APPROACH): Process Evaluation Study %A Kennedy,Fiona %A Smith,Susan %A Beeken,Rebecca J %A Buck,Caroline %A Williams,Sarah %A Martin,Charlene %A Lally,Phillippa %A Fisher,Abi %+ Department of Behavioural Science and Health, University College London, 1-19 Torrington Place, London, WC1E7HB, United Kingdom, 44 2076791722, abigail.fisher@ucl.ac.uk %K cancer %K physical activity %K process evaluation %K randomized controlled trial %K intervention %K app %K habit %D 2025 %7 10.2.2025 %9 Original Paper %J JMIR Cancer %G English %X Background: The APPROACH pilot study explored the feasibility and acceptability of an app (NHS Active 10) with brief, habit-based, behavioral support calls and print materials intended to increase brisk walking in people diagnosed with cancer. Objective: Following UK Medical Research Council guidelines, this study assessed the implementation of the intervention, examined the mechanisms of impact, and identified contextual factors influencing engagement. Methods: Adults (aged ≥18 y) with breast, prostate, or colorectal cancer who reported not meeting the UK guidelines for moderate-to-vigorous physical activity (≥150 min/wk) were recruited from a single hospital site in Yorkshire, United Kingdom. They were randomly assigned to the intervention or control (usual care) arm and assessed via quantitative surveys at baseline (time point 0 [T0]) and 3-month follow-up (time point 1 [T1]) and qualitative exit interviews (36/44, 82%) at T1. The process evaluation included intervention participants only (n=44). Implementation was assessed using data from the T1 questionnaire exploring the use of the intervention components. The perceived usefulness of the app, leaflet, and behavioral support call was rated from 0 to 5. Behavioral support calls were recorded, and the fidelity of delivery of 25 planned behavior change techniques was rated from 0 to 5 using an adapted Dreyfus scale. Mechanisms of impact were identified by examining T0 and T1 scores on the Self-Reported Behavioural Automaticity Index and feedback on the leaflet, app, call, and planner in the T1 questionnaire and qualitative interviews. Contextual factors influencing engagement were identified through qualitative interviews. Results: The implementation of the intervention was successful: 98% (43/44) of the participants received a behavioral support call, 78% (32/41) reported reading the leaflet, 95% (39/41) reported downloading the app, and 83% (34/41) reported using the planners. The mean perceived usefulness of the app was 4.3 (SD 0.8) in participants still using the app at T1 (n=33). Participants rated the leaflet (mean 3.9, SD 0.6) and the behavioral support call (mean 4.1, SD 1) as useful. The intended behavior change techniques in the behavioral support calls were proficiently delivered (overall mean 4.2, SD 1.2). Mechanisms of impact included habit formation, behavioral monitoring, and support and reassurance from the intervention facilitator. Contextual factors impacting engagement included barriers, such as the impact of cancer and its treatment, and facilitators, such as social support. Conclusions: The APPROACH intervention was successfully implemented and shows promise for increasing brisk walking, potentially through promoting habit formation and enabling self-monitoring. Contextual factors will be important to consider when interpreting outcomes in the larger APPROACH randomized controlled trial. International Registered Report Identifier (IRRID): RR2-10.1186/s40814-022-01028-w %M 39928926 %R 10.2196/64747 %U https://cancer.jmir.org/2025/1/e64747 %U https://doi.org/10.2196/64747 %U http://www.ncbi.nlm.nih.gov/pubmed/39928926 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e56203 %T Efficacy of a Blended Low-Intensity Internet-Delivered Psychological Program in Patients With Multimorbidity in Primary Care: Randomized Controlled Trial %A Monreal-Bartolomé,Alicia %A Castro,Adoración %A Pérez-Ara,M Ángeles %A Gili,Margalida %A Mayoral,Fermín %A Hurtado,María Magdalena %A Varela Moreno,Esperanza %A Botella,Cristina %A García-Palacios,Azucena %A Baños,Rosa M %A López-Del-Hoyo,Yolanda %A García-Campayo,Javier %A Montero-Marin,Jesus %+ Aragon Institute for Health Research, IIS Aragon, C. de Pedro Cerbuna, 12, Zaragoza, 50009, Spain, 34 686 673 302, jgarcamp@gmail.com %K multimorbidity %K depression %K type 2 diabetes %K low back pain %K primary care %K blended %K internet %K randomized controlled trial %K RCT %D 2025 %7 10.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Multimorbidity is a highly prevalent phenomenon whose presence causes a profound physical, psychological, and economic impact. It hinders help seeking, diagnosis, quality of care, and adherence to treatment, and it poses a significant dilemma for present-day health care systems. Objective: This study aimed to assess the effectiveness of improved treatment as usual (iTAU) combined with a blended low-intensity psychological intervention delivered using information and communication technologies for the treatment of multimorbidity (depression and type 2 diabetes or low back pain) in primary care settings. Methods: A 2-armed, parallel-group, superiority randomized controlled trial was designed for this study. Participants diagnosed with depression and either type 2 diabetes or low back pain (n=183) were randomized to “intervention + iTAU” (combining a face-to-face intervention with a supporting web-based program) or “iTAU” alone. The main outcome consisted of a standardized composite score to consider (1) severity of depressive symptoms and (2a) diabetes control or (2b) pain intensity and physical disability 3 months after the end of treatment as the primary end point. Differences between the groups were estimated using mixed effects linear regression models, and mediation evaluations were conducted using path analyses to evaluate the potential mechanistic role of positive and negative affectivity and openness to the future. Results: At 3-month follow-up, the intervention + iTAU group (vs iTAU) exhibited greater reductions in composite multimorbidity score (B=–0.34, 95% CI –0.64 to –0.04; Hedges g=0.39) as well as in depression and negative affect and improvements in perceived health, positive affect, and openness to the future. Similar positive effects were observed after the intervention, including improvements in physical disability. No significant differences were found in glycosylated hemoglobin, pain intensity, or disability at 3-month follow-up (P=.60; P=.79; and P=.43, respectively). Path analyses revealed that the intervention had a significant impact on the primary outcome, mediated by both positive and negative affect (positive affect: indirect effect=–0.15, bootstrapped 95% CI –0.28 to –0.03; negative affect: indirect effect=–0.14, bootstrapped 95% CI –0.28 to –0.02). Conclusions: This study supports the efficacy of a low-intensity psychological intervention applied in a blended format on multimorbidity in primary care. It justifies the exploration of the conceptualization of depression in type 2 diabetes as well as the analysis of the implementation of such interventions in routine clinical practice. Trial Registration: ClinicalTrials.gov NCT03426709; https://clinicaltrials.gov/study/NCT03426709 International Registered Report Identifier (IRRID): RR2-10.1186/S12888-019-2037-3 %M 39928931 %R 10.2196/56203 %U https://www.jmir.org/2025/1/e56203 %U https://doi.org/10.2196/56203 %U http://www.ncbi.nlm.nih.gov/pubmed/39928931 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e63819 %T A Web-Based Resource Informed by Cognitive Behavioral Therapy and Positive Psychology to Address Stress, Negative Affect, and Problematic Alcohol Use: A Usability and Descriptive Study %A Serck-Hanssen,Ingrid %A Solheim-Witt,Marit %A Anker,Justin J %A Sugarman,Dawn E %K alcohol misuse %K stress %K drinking to cope %K DTC %K negative affect %K positive psychology intervention %K PPI %K cognitive behavior therapy %K CBT %K alcohol use %K drinking %K usability %K descriptive study %K behavior %K emotion %K coping skill %K positive psychology %K psychology %K online resource %K mobile phone %D 2025 %7 10.2.2025 %9 %J JMIR Form Res %G English %X Background: Research documents that drinking to cope behavior can be disrupted by enhancing emotion regulation and coping skills related to the experience of stress and negative affect. The Alpha Element Self-Coaching Plan incorporates principles of positive psychology and cognitive behavioral therapy to redirect negative thinking and emotions and, therefore, has the potential to benefit individuals who use alcohol to cope with stress. Objective: This study aimed to evaluate satisfaction and usability of the web-based Alpha Element Self-Coaching Plan in order to inform the development of an expanded digital platform based on the Alpha Element framework. Methods: Participants enrolled in the web-based program as part of their clinical care were eligible to participate. A total of 20 individuals (14 women and 6 men) between ages 30 and 79 (mean 54.5, SD 14.14) years completed web-based questionnaires to assess product performance in areas such as ease of technology use, quality of videos and handouts, and the value of the activities. Participants also completed the System Usability Scale (SUS) and provided background and demographic information, including alcohol use. Results: Only 1 participant reported no alcohol use in the past year; 55% (11/20) of participants drank alcohol 2‐4 times per month or less and 45% (9/20) reported drinking alcohol 2‐3 times per week or more. The average SUS score of 76.38 (SD 17.85) was well above the commonly accepted threshold of 68, indicating high system usability. A majority of the sample (16/19, 84%) agreed or strongly agreed that the activities in the program inspired behavioral changes; and most agreed or strongly agreed that the program was engaging (16/20, 80%), well-organized (18/20, 90%), and easy to follow (17/20, 85%). Only 2 participants endorsed experiencing difficulty using the program on a smartphone. Suggestions for program improvements included expanding the platform, updating the web format, adding user interactivity, and enhancing navigation. Conclusions: These data suggest that participants were generally satisfied with the web-based Alpha Element Self-Coaching Plan, and rated usability of the program as favorable. Importantly, a significant portion of participants reported that the program inspired behavioral changes. More research is needed with a larger sample to obtain specific data about alcohol consumption and investigate associations between alcohol use and program components, as well as examine gender differences. Data collected from this study will be used to expand the platform and improve user experience. %R 10.2196/63819 %U https://formative.jmir.org/2025/1/e63819 %U https://doi.org/10.2196/63819 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e68914 %T Web-Based, Algorithm-Guided Insulin Titration in Insulin-Treated Type 2 Diabetes: Pre-Post Intervention Study %A Thiagarajan,Nishanth %A Tan,Hong Chang %A Rama Chandran,Suresh %A Lee,Phong Ching %A Chin,Yun Ann %A Zeng,Wanling %A Ho,Emily Tse Lin %A Carmody,David %A Goh,Su-Yen %A Bee,Yong Mong %K diabetes %K insulin %K monitoring %K technology %K mobile %K app %K intervention %D 2025 %7 7.2.2025 %9 %J JMIR Form Res %G English %X Background: Self-monitoring of blood glucose (SMBG) using web-based diabetes management platforms has demonstrated promise in managing type 2 diabetes (T2D). However, the effectiveness of such systems incorporating algorithm-guided insulin titration has not been extensively studied in Asian populations. Objective: This study evaluates the efficacy and safety of the ALRT telehealth solution—a US Food and Drug Administration–cleared, web-based platform that integrates SMBG with algorithm-driven insulin dose adjustments—in improving glycemia in insulin-treated T2D. Methods: This 24-week, pre-post intervention study enrolled 25 adults with T2D (mean age 58.9, SD 7.0 y; n=14, 56% male) on twice-daily premixed insulin. Inclusion criteria included a baseline hemoglobin A1c (HbA1c) level between 7.5% to 9.9% (58‐86 mmol/mol), a BMI ≤40 kg/m², and experience with SMBG. Participants uploaded twice-daily SMBG data weekly via a mobile app, which generated insulin titration recommendations based on a predefined algorithm. Physicians reviewed and approved the recommendations, which were then communicated back to participants via the app. The primary outcome was the change in HbA1c level from baseline to 24 weeks. Secondary outcomes included changes in fasting plasma glucose, insulin dose, hypoglycemia incidence, and SMBG adherence. Results: Participants achieved significant reductions in HbA1c level from 8.6% (70 mmol/mol) at baseline to 7.4% (57 mmol/mol) at 24 weeks (P<.001), with reductions of 0.8% and 0.4% in the first and second 12 weeks, respectively. Fasting plasma glucose decreased from 8.7 (SD 2.0) mmol/L to 7.1 (SD 1.4) mmol/L (P<.001). Mean total daily insulin dose increased modestly from 0.73 (SD 0.31) units/kg/day to 0.79 (SD 0.34) units/kg/day (P=.007). Participants demonstrated high adherence, completing 97.3% (327/336) of prescribed SMBG measurements. During the study, 48% (12/25) of participants experienced at least 1 hypoglycemia episode, predominantly mild hypoglycemia (85/96, 88.5%; glucose 3.0‐3.9 mmol/L). Hypoglycemia episodes increased from 24 during weeks 0‐12 to 72 during weeks 13‐24. There were no episodes of severe hypoglycemia requiring external assistance. BMI increased slightly from 29.0 (SD 3.6) kg/m² to 29.5 (SD 3.6) kg/m² (P=.03), reflecting a modest weight gain associated with improved glycemia. Conclusions: In conclusion, patients with insulin-treated T2D initiated on a web-based glucose monitoring system with algorithm-guided dosing recommendations showed significant improvement in glycemic control compared to baseline. High adherence rates underscore the feasibility of integrating algorithm-guided insulin titration into routine care. While hypoglycemia incidence rose slightly, episodes were predominantly mild, and no severe events occurred. This intervention shows promise for broader adoption in T2D management, particularly in resource-constrained settings. %R 10.2196/68914 %U https://formative.jmir.org/2025/1/e68914 %U https://doi.org/10.2196/68914 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e65140 %T Improving the Utility, Safety, and Ethical Use of a Passive Mood-Tracking App for People With Bipolar Disorder Using Coproduction: Qualitative Focus Group Study %A Astill Wright,Laurence %A Moore,Matthew %A Reeves,Stuart %A Vallejos,Elvira Perez %A Morriss,Richard %+ Institute of Mental Health, University of Nottingham, Jubilee Campus, Triumph Road, Nottingham, NG7 2TU, United Kingdom, 44 115 823 1294, laurence.astillwright@nottingham.ac.uk %K mood monitoring %K ecological momentary assessment %K EMA %K passive ecological momentary assessment %K passive EMA %K bipolar disorder %K implementation %K qualitative %K mobile phone %D 2025 %7 7.2.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Coproduction with users of new digital technology, such as passive mood monitoring, is likely to improve its utility, safety, and successful implementation via improved design and consideration of how such technology fits with their daily lives. Mood-monitoring interventions are commonly used by people with bipolar disorder (BD) and have promising potential for digitization using novel technological methods. Objective: This study aims to explore how a passive behavioral monitoring platform, Remote Assessment of Disease and Relapse, would meet the needs of people with BD by specifically considering purpose and function, diversity of need, personal preference, essential components and potential risks, and harms and mitigation strategies through an iterative coproduction process. Methods: A total of 17 people with BD were recruited via national charities. We conducted 3 web-based focus groups as a part of an iterative coproduction process in line with responsible research and innovation principles and with consideration of clinical challenges associated with BD. Data were analyzed thematically. Results were cross-checked by someone with lived experience of BD. Results: Focus groups were transcribed and analyzed using thematic analysis. Six themes were identified as follows: (1) the purpose of using the app, (2) desired features, (3) when to use the app, (4) risks of using the app, (5) sharing with family and friends, and (6) sharing with health care professionals. Conclusions: People with BD who are interested in using passive technology to monitor their mood wish to do so for a wide variety of purposes, identifying several preferences and potential risks. Principally, people with BD wished to use this novel technology to aid them in self-managing their BD with greater insight and a better understanding of potential triggers. We discuss key features that may aid this functionality and purpose, including crisis plans and sharing with others. Future development of passive mood-monitoring technologies should not assume that the involvement of formal mental health services is desired. %M 39918865 %R 10.2196/65140 %U https://formative.jmir.org/2025/1/e65140 %U https://doi.org/10.2196/65140 %U http://www.ncbi.nlm.nih.gov/pubmed/39918865 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e53566 %T Adapting a Mobile Health App for Smoking Cessation in Black Adults With Anxiety Through an Analysis of the Mobile Anxiety Sensitivity Program Proof-of-Concept Trial: Qualitative Study %A Cheney,Marshall K %A Alexander,Adam C %A Garey,Lorra %A Gallagher,Matthew W %A Hébert,Emily T %A Vujanovic,Anka A %A Kezbers,Krista M %A Matoska,Cameron T %A Zvolensky,Michael J %A Businelle,Michael S %+ Department of Health and Exercise Science, University of Oklahoma, 1401 Asp Ave, Norman, OK, 73019, United States, 1 4053255211, marshall@ou.edu %K cultural tailoring %K tailoring %K African American %K black %K smoking cessation %K mHealth %K smartphone application %K just in time adaptive intervention %K qualitative %K formative evaluation %K app %K application %K anxiety %K adult %K qualitative analysis %K smoking %K mobile phone %K tobacco %D 2025 %7 7.2.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: At least half of smokers make a serious quit attempt each year, but Black adults who smoke are less likely than White adults who smoke to quit smoking successfully. Black adults who smoke and have high anxiety sensitivity (an individual difference factor implicated in smoking relapse and culturally relevant to Black adults) are even less successful. The Mobile Anxiety Sensitivity Program for Smoking (MASP) is a smoking cessation smartphone app culturally tailored to Black adults who smoke to increase smoking cessation rates by targeting anxiety sensitivity. Objective: This study examined the acceptability and feasibility of the MASP smartphone app following a 6-week pilot test through postintervention qualitative interviews. Methods: The MASP smoking cessation app was adapted from an evidence-based app by adding culturally tailored narration and images specific to the Black community, educational content on tobacco use in the Black community and the role of menthol, culturally tailored messages, and addressing tobacco use and racial discrimination. The MASP app was piloted with 24 adults with high anxiety sensitivity who identified as Black, smoked daily, and were not currently using medications or psychotherapy for smoking cessation. At the end of the 6-week pilot test, 21/24 participants (67% female; 95.2% non-Hispanic; mean age=47.3 years; 43% college educated; 86% single or separated) completed an audio-recorded semistructured interview assessing the acceptability and utility of the app, individual experiences, barriers to use, the cultural fit for Black adults who wanted to quit smoking, and identified areas for improvement. Transcribed interviews were coded using NVivo (Lumivero), and then analyzed for themes using an inductive, use-focused process. Results: Most participants (17/21, 81%) had smoked for more than 20 years and 29% (6/21) of them smoked more than 20 cigarettes daily. Participants felt the MASP app was helpful in quitting smoking (20/21, 95%) and made them more aware of smoking thoughts, feelings, and behaviors (16/19, 84%). Half of the participants (11/21, 52%) thought the combination of medication and smartphone app gave them the best chance of quitting smoking. Themes related to participant experiences using the app included establishing trust and credibility through the recruitment experience, providing personally tailored content linked to evidence-based stress reduction techniques, and self-reflection through daily surveys. The culturally tailored material increased app relevance, engagement, and acceptability. Suggested improvements included opportunities to engage with other participants, more control over app functions, and additional self-monitoring functions. Conclusions: Adding culturally tailored material to an evidence-based mobile health (mHealth) intervention could increase the use of smoking cessation interventions among Black adults who want to quit smoking. Qualitative interviews provide mHealth app developers important insights into how apps can be improved before full study implementation and emphasize the importance of getting feedback from the target population throughout the development process of mHealth interventions. Trial Registration: ClinicalTrials.gov NCT04838236; https://clinicaltrials.gov/ct2/show/NCT04838236 %M 39918847 %R 10.2196/53566 %U https://formative.jmir.org/2025/1/e53566 %U https://doi.org/10.2196/53566 %U http://www.ncbi.nlm.nih.gov/pubmed/39918847 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e55541 %T Smartphone-Based Intervention Targeting Norms and Risk Perception Among University Students with Unhealthy Alcohol Use: Secondary Mediation Analysis of a Randomized Controlled Trial %A Studer,Joseph %A Cunningham,John A %A Schmutz,Elodie %A Gaume,Jacques %A Adam,Angéline %A Daeppen,Jean-Bernard %A Bertholet,Nicolas %+ Addiction Medicine, Department of Psychiatry, Lausanne University Hospital and University of Lausanne, Rue du Bugnon 23A, Lausanne, 1011, Switzerland, 41 213149033, joseph.studer@chuv.ch %K brief intervention %K alcohol use %K mechanism of action %K mediation analysis %K personalized feedback %K smartphone app %K students %K Switzerland %K mobile phone %K mediation %K feedback %K student %K health risk %K drinking %K drinker %K support %K feedback intervention %D 2025 %7 6.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Many digital interventions for unhealthy alcohol use are based on personalized normative feedback (PNF) and personalized feedback on risks for health (PFR). The hypothesis is that PNF and PFR affect drinkers’ perceptions of drinking norms and risks, resulting in changes in drinking behaviors. This study is a follow-up mediation analysis of the primary and secondary outcomes of a randomized controlled trial testing the effect of a smartphone-based intervention to reduce alcohol use. Objective: This study aimed to investigate whether perceptions of drinking norms and risks mediated the effects of a smartphone-based intervention to reduce alcohol use. Methods: A total of 1770 students from 4 higher education institutions in Switzerland (mean age 22.35, SD 3.07 years) who screened positive for unhealthy alcohol use were randomized to receive access to a smartphone app or to the no-intervention control condition. The smartphone app provided PNF and PFR. Outcomes were drinking volume (DV) in standard drinks per week and the number of heavy drinking days (HDDs) assessed at baseline and 6 months. Mediators were perceived drinking norms and perceived risks for health measured at baseline and 3 months. Parallel mediation analyses and moderated mediation analyses were conducted to test whether (1) the intervention effect was indirectly related to lower DV and HDDs at 6 months (adjusting for baseline values) through perceived drinking norms and perceived risks for health at 3 months (adjusting for baseline values) and (2) the indirect effects through perceived drinking norms differed between participants who overestimated or who did not overestimate other people’s drinking at baseline. Results: The intervention’s total effects were significant (DV: b=–0.85, 95% bootstrap CI –1.49 to –0.25; HDD: b=–0.44, 95% bootstrap CI –0.72 to –0.16), indicating less drinking at 6 months in the intervention group than in the control group. The direct effects (ie, controlling for mediators) were significant though smaller (DV: b=–0.73, 95% bootstrap CI –1.33 to –0.16; HDD: b=–0.39, 95% bootstrap CI –0.66 to –0.12). For DV, the indirect effect was significant through perceived drinking norms (b=–0.12, 95% bootstrap CI –0.25 to –0.03). The indirect effects through perceived risk (for DV and HDD) and perceived drinking norms (for HDD) were not significant. Results of moderated mediation analyses showed that the indirect effects through perceived drinking norms were significant among participants overestimating other people’s drinking (DV: b=–0.17, 95% bootstrap CI –0.32 to –0.05; HDD: b=–0.08, 95% bootstrap CI –0.15 to –0.01) but not significant among those not overestimating. Conclusions: Perceived drinking norms, but not perceived risks, partially mediated the intervention’s effect on alcohol use, confirming one of its hypothesized mechanisms of action. These findings lend support to using normative feedback interventions to discourage unhealthy alcohol use. Trial Registration: ISRCTN Registry 10007691; https://doi.org/10.1186/ISRCTN10007691 %M 39914807 %R 10.2196/55541 %U https://www.jmir.org/2025/1/e55541 %U https://doi.org/10.2196/55541 %U http://www.ncbi.nlm.nih.gov/pubmed/39914807 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e64097 %T Barriers and Facilitators to User Engagement and Moderation for Web-Based Peer Support Among Young People: Qualitative Study Using the Behavior Change Wheel Framework %A Ananya,Ananya %A Tuuli,Janina %A Perowne,Rachel %A Gutman,Leslie Morrison %+ Department of Clinical, Educational and Health Psychology, Faculty of Brain Sciences, University College London, 1-19 Torrington Place, London, WC1E 7HB, United Kingdom, 44 8059 0939, l.gutman@ucl.ac.uk %K internet %K moderation %K engagement %K youth %K teenager %K adolescent %K peer support %K web-based group %K user engagement %K support group %K barrier %K facilitator %K Theoretical Domains Framework %K Behavior Change Wheel %K qualitative %K interview %K behavior change technique %K thematic analysis %D 2025 %7 5.2.2025 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Peer support groups or web-based chats for young people offer anonymous peer support in judgment-free spaces, where users may share their thoughts and feelings with others who may have experienced similar situations. User engagement is crucial for effective web-based peer support; however, levels of engagement vary. While moderation of peer support groups can have a positive impact on the engagement of young people, effective moderation can be challenging to implement. Objective: This study aimed to identify barriers and facilitators to user engagement with, and moderation of, web-based peer support groups among young people aged 16 to 25 years and to provide recommendations for enhancing this service. Methods: Drawing upon the Theoretical Domains Framework (TDF) and the Behavior Change Wheel (BCW), this study conducted qualitative interviews and gathered open-ended questionnaires from service users and moderators of The Mix, the United Kingdom’s leading web-based mental health platform providing peer support groups for young people. Semistructured interviews were conducted with 2 service users and 8 moderators, and open-ended questionnaires were completed by 7 service users. Themes were coded using the Capability, Opportunity, Motivation, and Behavior (COM-B) model and the TDF. The BCW tools were then used to identify relevant behavior change techniques to improve user engagement in, and moderation of, the service. Results: Thematic analysis revealed a total of 20 inductive themes within 10 TDF domains—9 (45%) for engagement and 11 (55%) for moderation. Of these 20 themes, 3 (15%) were facilitators of engagement, 7 (35%) were facilitators of moderation, 4 (20%) were barriers to moderation, and 6 (30%) barriers to engagement. Results suggest that skills, knowledge, beliefs about consequences, intentions, emotions, and the social and physical environment are important factors influencing service users and moderators of group chats. In particular, supporting the improvement of memory, attention, and decision-making skills of those involved; adapting the physical environment to facilitate effective interactions; and reducing negative emotions are suggested to optimize the value and effectiveness of peer support groups for young people’s mental health for both the service users and moderators of these services. Conclusions: The study demonstrates the effectiveness of the BCW approach and the use of the TDF and COM-B model to understand the influences on behavior in a systematic manner, especially for mental health and well-being interventions. The findings can be applied to design structured interventions to change behaviors related to the engagement with, and moderation of, web-based peer support groups and, in turn, improve mental health outcomes for young people. %M 39908551 %R 10.2196/64097 %U https://humanfactors.jmir.org/2025/1/e64097 %U https://doi.org/10.2196/64097 %U http://www.ncbi.nlm.nih.gov/pubmed/39908551 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 11 %N %P e50662 %T The Effect of Nutritional Mobile Apps on Populations With Cancer: Systematic Review %A Ng,Krystal Lu Shin %A Munisamy,Murallitharan %A Lim,Joanne Bee Yin %A Alshagga,Mustafa %+ Division of Biomedical Sciences, Faculty of Science and Engineering, University of Nottingham Malaysia Campus, Jalan Broga, Semenyih, 43500, Malaysia, 60 172306490, krystal_1224@hotmail.com %K cancer %K mobile app %K nutrition %K body composition %K quality of life %K mobile health %K mHealth %K diet %K intervention %K mobile phone %K PRISMA %D 2025 %7 5.2.2025 %9 Review %J JMIR Cancer %G English %X Background: Limited access to nutrition support among populations with cancer is a major barrier to sustainable and quality cancer care. Increasing use of mobile health in health care has raised concerns about its validity and health impacts. Objective: This systematic review aimed to determine the effectiveness of commercial or cancer-specific nutritional mobile apps among people living with cancer. Methods: A systematic search of the CENTRAL, Embase, PubMed (MEDLINE), and Scopus databases was carried out in May 2024. All types of intervention studies were included, except observational studies, gray literature, and reference lists of key systematic reviews. Studies were eligible for inclusion if they involved (1) patients with or survivors of cancer and (2) nutrition-related mobile apps. Studies were excluded if the nutrition intervention was not delivered via mobile app or the app intervention was accompanied by dietary counseling. The review process was conducted based on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The Risk of Bias 2 and Risk of Bias in Nonrandomized Studies tools were used to assess the study quality. The Cochrane Review Manager (version 5.4) software was used to synthesize the results of the bias assessment. Results: A total of 13 interventions were included, comprising 783 adults or teenagers with cancer. Most studies focused on breast cancer (6/13, 46%), overweight (6/13, 46%), and survivors (9/13, 69%). Data on anthropometry and body composition (7/13, 54%; 387 participants), nutritional status (3/13, 23%; 249 participants), dietary intake (7/13, 54%; 352 participants), and quality of life (6/13, 46%; 384 participants) were gathered. Experimental groups were more likely to report significant improvements in body weight or composition, dietary compliance, nutritional status, and quality of life than control groups. Conclusions: Although mobile app platforms are used to deliver nutrition interventions, the evidence for long-term efficacy, particularly in populations with cancer, remains elusive. More robust randomized controlled trials with larger sample sizes, as well as more homogeneous population characteristics and outcome measures, are warranted. Trial Registration: PROSPERO CRD42023330575; https://tinyurl.com/55v56yaj %M 39908548 %R 10.2196/50662 %U https://cancer.jmir.org/2025/1/e50662 %U https://doi.org/10.2196/50662 %U http://www.ncbi.nlm.nih.gov/pubmed/39908548 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e67263 %T Development of a Web-Based Intervention for Middle Managers to Enhance Resilience at the Individual, Team, and Organizational Levels in Health Care Systems: Multiphase Study %A Gil-Hernández,Eva %A Carrillo,Irene %A Martin-Delgado,Jimmy %A García-Torres,Daniel %A Mira,José Joaquín %+ Health Psychology Department, Universidad Miguel Hernández, Avinguda de la Universitat d'Elx, Elche, 03202, Spain, 34 966658984, jose.mira@umh.es %K resilience %K health care professionals %K web-based intervention %K middle management %K well-being %K patient safety %D 2025 %7 5.2.2025 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Health care institutions face high systemic risk due to the inherent uncertainty and complexity of their operations. This often leads to stressful incidents impacting the well-being of health care professionals, which can compromise the effectiveness of health care systems. Enhancing resilience among health care professionals is essential for maintaining high-quality care and ensuring patient safety. The role of middle managers is essential to ensure the response capacity of individuals and teams. Objective: This study aims to develop a web-based intervention aimed at middle management to enhance individual, team, and organizational resilience. Methods: An observational study was conducted in 3 phases: design, validation, and pilot study. The study was initiated in February 2022 and concluded in June 2023. Phase 1 involved designing the content for the web-based tool based on a comprehensive review of critical elements around resilience. Phase 2 included validation by an international panel of experts who reviewed the tool and rated it according to a structured grid. They were also encouraged to highlight strengths and areas for improvement. Phase 3 involved piloting the tool with health care professionals in Ecuador to refine the platform and assess its effectiveness. A total of 458 people were invited to participate through the Institutional Course on Continuous Improvement in Health Care Quality and Safety offered by the Ministry of Public Health of Ecuador. Results: The tool, eResiliencia, was structured into 2 main blocks: individual and team resilience and organizational resilience. It included videos, images, PDFs, and links to dynamic graphics and additional texts. Furthermore, 13 (65%) of the 20 experts validated the tool, rating content clarity at an average of 4.5 (SD 0.7) and utility at an average of 4.7 (SD 0.5) out of 5. The average overall satisfaction was 9.3 (SD 0.6) out of 10 points, and feedback on improvements was implemented. A total of 362 health care professionals began the intervention, of which 218 (60.2%) completed preintervention and postintervention questionnaires, with significant knowledge increases (P<.001). Of the 362 health care professionals, 146 (40.3%) completed the satisfaction questionnaire, where overall satisfaction was rated at an average of 9.4 (SD 1.1) out of 10 points. Conclusions: The eResiliencia web-based platform provides middle managers with resources to enhance resilience among their teams and their components, promoting better well-being and performance, even under highly stressful events. Future research should focus on long-term impacts and practical applications in diverse clinical settings. %M 39908547 %R 10.2196/67263 %U https://humanfactors.jmir.org/2025/1/e67263 %U https://doi.org/10.2196/67263 %U http://www.ncbi.nlm.nih.gov/pubmed/39908547 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 11 %N %P e63428 %T The Effects of MyChoices and LYNX Mobile Apps on HIV Testing and Pre-Exposure Prophylaxis Use by Young US Sexual Minority Men: Results From a National Randomized Controlled Trial %A Biello,Katie B %A Mayer,Kenneth H %A Scott,Hyman %A Valente,Pablo K %A Hill-Rorie,Jonathan %A Buchbinder,Susan %A Ackah-Toffey,Lucinda %A Sullivan,Patrick S %A Hightow-Weidman,Lisa %A Liu,Albert Y %+ Department of Epidemiology, School of Public Health, Brown University, 121 South Main Street, Box G-S121-2, Providence, RI, 02912, United States, 1 4018633082, katie_biello@brown.edu %K HIV testing %K adolescents %K sexual minority men %K mobile apps %K pre-exposure prophylaxis %K youths %K randomized controlled trial %K sexual minority %K United States %K efficacy %K LYNX %K MyChoices %K sociodemographic %K behavioral health %K HIV prevention %K HIV infection %K HIV care %K transmission %K public health %K mHealth %K mobile phones %D 2025 %7 5.2.2025 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: Young sexual minority men have among the highest rates of HIV in the United States; yet, the use of evidence-based prevention strategies, including routine HIV testing and pre-exposure prophylaxis (PrEP), remains low. Mobile apps have enormous potential to increase HIV testing and PrEP use among young sexual minority men. Objective: This study aims to assess the efficacy of 2 theory- and community-informed mobile apps—LYNX (APT Mobility) and MyChoices (Keymind)—to improve HIV testing and PrEP initiation among young sexual minority men. Methods: Between October 2019 and May 2022, we implemented a 3-arm, parallel randomized controlled trial in 9 US cities to test the efficacy of the LYNX and MyChoices apps against standard of care (SOC) among young sexual minority men (aged 15-29 years) reporting anal sex with cisgender male or transgender female in the last 12 months. Randomization was 1:1:1 and was stratified by site and participant age; there was no masking. The co-primary outcomes were self-reported HIV testing and PrEP initiation over 6 months of follow-up. Results: A total of 381 young sexual minority men were randomized. The mean age was 22 (SD 3.2) years. Nearly one-fifth were Black, non-Hispanic (n=67, 18%), Hispanic or Latino men (n=67, 18%), and 60% identified as gay (n=228). In total, 200 (53%) participants resided in the Southern United States. At baseline, participants self-reported the following: 29% (n=110) had never had an HIV test and 85% (n=324) had never used PrEP. Sociodemographic and behavioral characteristics did not differ by study arm. Compared to SOC (n=72, 59%), participants randomized to MyChoices (n=87, 74%; P=.01) were more likely to have received at least 1 HIV test over 6 months of follow-up; those randomized to LYNX also had a higher proportion of testing (n=80, 70%) but it did not reach the a priori threshold for statistical significance (P=.08). Participants in both MyChoices (n=23, 21%) and LYNX (n=21, 20%) arms had higher rates of starting PrEP compared to SOC (n=19, 16%), yet these differences were not statistically significant (P=.52). Conclusions: In addition to facilitating earlier treatment among those who become aware of their HIV status, given the ubiquity of mobile apps and modest resources required to scale this intervention, a 25% relative increase in HIV testing among young sexual minority men, as seen in this study, could meaningfully reduce HIV incidence in the United States. Trial Registration: ClinicalTrials.gov NCT03965221; https://clinicaltrials.gov/study/NCT03965221 %M 39908084 %R 10.2196/63428 %U https://publichealth.jmir.org/2025/1/e63428 %U https://doi.org/10.2196/63428 %U http://www.ncbi.nlm.nih.gov/pubmed/39908084 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 8 %N %P e55023 %T Digital Health Program to Support Family Caregivers of Children Undergoing Growth Hormone Therapy: Qualitative Feasibility Study %A Jiménez-Díaz,Alba %A Pierantonelli,Maitena %A Morte Coscolín,Patricia %A Salinas-Uhalte,Amaia %A Quer-Palomas,Silvia %A Rivera-Romero,Octavio %A Herrero,Rocío %A Fernández-Luque,Luis %A Baños,Rosa %A Berrios,Ricardo C %A de Arriba,Antonio %+ Unidad de Endocrinología Pediátrica, Hospital Universitario Miguel Servet, Paseo Isabel la Católica, 1, Zaragoza, 50009, Spain, 34 976765500, adearriba@salud.aragon.es %K growth hormone deficiency %K mobile based solutions %K caregivers %K technology acceptance %K digital health %K children %K therapy %K feasibility study %K health condition %K psychological burden %K quality of life %K wellbeing %K pediatric %K mobile Health %K mHealth %K behavioral change %K parent-child relationship %D 2025 %7 5.2.2025 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Caregivers of children with growth hormone deficiency often face emotional challenges (eg, stress) associated with their children’s health conditions. This psychological burden might affect children’s adherence to treatment and hinder their health-related quality of life (HrQoL). This assumption is leading to seriously considering multidimensional clinical approaches to pediatric health conditions where the emotional well-being of caregivers should be accounted for to optimize children’s health outcomes. Novel mobile health (mHealth) solutions based on emotional and behavioral change techniques can play a promising role because they are increasingly used within different health areas to support adaptive psychological functioning. However, whether and how mHealth solutions of this type of emotional well-being support caregivers of children with growth-related problems is an issue that needs to be clarified. Objective: This study aimed to gather qualitative information to better understand individualized experiences of caregiving of children undergoing growth hormone therapy (GHt) and perceived barriers or facilitators for the adoption of an mHealth solution called Adhera Caring Digital Program (ACDP). Methods: A total of 10 family caregivers were recruited at Miguel Servet Children’s Hospital, and they engaged with the ACDP for 1 month. The ACDP is a mobile-based digital intervention focused on promoting the overall well-being of family caregivers which provides access to personalized education, motivational mobile-based messages, and mental well-being exercises such as mindfulness or respiratory exercises. Subsequently, an individual semistructured interview was performed to gather qualitative user experience information. Results: The digital intervention was well-received. The ACDP was found to be useful, easy to use, and understandable, addressing all the difficulties expressed by caregivers. It was also noted to be particularly helpful at the beginning of the treatment and, for some families, became a natural tool that strengthened the parent-child relationship. Conclusions: The ACDP is a promising and well-accepted tool that enhances the experience of patients and caregivers. It improves the management of growth hormone deficiency and promotes the overall well-being of family caregivers. Trial Registration: ClinicalTrials NCT04812665; https://clinicaltrials.gov/study/NCT04812665 International Registered Report Identifier (IRRID): RR2-10.1186/s12911-022-01935-1 %M 39908086 %R 10.2196/55023 %U https://pediatrics.jmir.org/2025/1/e55023 %U https://doi.org/10.2196/55023 %U http://www.ncbi.nlm.nih.gov/pubmed/39908086 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e58026 %T Effect of an Internet-Based Pilates Telerehabilitation Intervention in People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial %A Tacchino,Andrea %A Ponzio,Michela %A Confalonieri,Paolo %A Leocani,Letizia %A Inglese,Matilde %A Centonze,Diego %A Cocco,Eleonora %A Gallo,Paolo %A Paolicelli,Damiano %A Rovaris,Marco %A Sabattini,Loredana %A Tedeschi,Gioacchino %A Prosperini,Luca %A Patti,Francesco %A Sessa,Edoardo %A Pedrazzoli,Elisabetta %A Battaglia,Mario Alberto %A Brichetto,Giampaolo %+ Scientific Research Area, Italian Multiple Sclerosis Foundation, Via Operai 40, Genoa, 16149, Italy, 39 0102713812, andrea.tacchino@aism.it %K exergame %K MS-FIT %K Pilates %K Kinect %K multiple sclerosis %K exercise %K physical activity %K leisure time physical activity %K Timed Up and Go %D 2025 %7 3.2.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Physical activity (PA) has been recommended in multiple sclerosis (MS) to maintain good physical fitness and mental health, reduce the severity of symptoms and risk of relapse, and improve quality of life. Pilates has been suggested as an ideal PA to manage physical, cognitive, and psychological symptoms of MS and a useful method to maintain and improve balance and gait. Objective: This paper presents the protocol for a study that aims to evaluate the efficacy on the physical domain (specifically balance and gait) of a home-based, self-managed PA intervention delivered through the MS-FIT exergame (HELAGLOBE Società a responsabilità limitata). In addition, measures of cognitive performance, quality of life, and well-being will be considered. Methods: This is a 2-arm, multicenter, randomized controlled trial with 3 assessment points (baseline, 12 weeks postintervention, and 6 weeks follow-up). People with MS with mild disability, low risk of falling, preserved cognitive functions, and low anxiety and depression are potential eligible participants. The experimental group (MS-FIT) will self-administer the MS-FIT exergame at home in addition to their leisure-time physical activities. MS-FIT is an internet- and Pilates-based tool that uses the Microsoft Kinect Sensor V2. Participants in the control group will only have access to their leisure-time physical activities. Participants in the MS-FIT group will train at home with MS-FIT for 12 weeks and will be required to perform the exercises for a total of 30 minutes/day for at least 3 days/week. The primary outcome is the Timed Up and Go, a test designed to assess walking. We will also administer additional tests for motor function (visual analog scale 0-10, Timed 25-Foot Walk, Ambulation Index, 2-minute walk test, Twelve Item Multiple Sclerosis Walking Scale, Nine-Hole Peg Test), cognition (Brief International Cognitive Assessment for Multiple Sclerosis), fatigue (Modified Fatigue Impact Scale), quality of life (Multiple Sclerosis Quality of Life-54), well-being (Psychological Well-Being Scales), and PA (International Physical Activity Questionnaire and Minnesota Leisure Time Physical Activity Questionnaire). Acceptance and satisfaction with the intervention received (Client Satisfaction Questionnaire and an adapted version of the Tele-healthcare Satisfaction Questionnaire – Wearable Technology) and subjective impressions of changes in performance (Patients’ Global Impression of Change) will also be assessed. Results: Recruitment for the trial started on March 16, 2022, and the first participant was randomized the same day. Data analysis and results are expected to be published in 2025. Conclusions: Pilates has proven beneficial in several neurological diseases such as MS. With this study, we will provide evidence for the use in clinical practice of a digital tool for self-administered Pilates exercises at home as a complement to rehabilitation and for the continuity of care in MS. Trial Registration: ClinicalTrials.gov NCT04011579; https://tinyurl.com/2p9n4d2t International Registered Report Identifier (IRRID): DERR1-10.2196/58026 %M 39899835 %R 10.2196/58026 %U https://www.researchprotocols.org/2025/1/e58026 %U https://doi.org/10.2196/58026 %U http://www.ncbi.nlm.nih.gov/pubmed/39899835 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e63139 %T Effectiveness of Cognitive Behavioral Therapy Provided Through a Web Application for Subthreshold Depression, Subthreshold Insomnia, and Subthreshold Panic: Open-Labeled 6-Arm Randomized Clinical Trial Pilot Study %A Taguchi,Kayoko %A Miyoshi,Mirai %A Seki,Yoichi %A Baba,Shiori %A Shimizu,Eiji %+ Research Center for Child Mental Development, Chiba University, chuo-ku, Inohana 1-8-1, Chiba, 260-8670, Japan, 81 43 226 2027, k.taguchi@chiba-u.jp %K minimally important change %K nonguided cognitive behavioral therapy %K subthreshold depression %K subthreshold insomnia %K subthreshold panic %K cognitive behavioral therapy %K CBT %K psychiatric disease %K primary care %K interventions %K depression %K anxiety %K insomnia %K psychological therapy %D 2025 %7 3.2.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: A common definition of “subthreshold” is that the diagnostic threshold is not met but the individuals are not asymptomatic. Some symptoms are present, causing significant difficulty in functioning and negatively impacting quality of life. Despite the attention given to subthreshold symptoms and the interventions for subthreshold symptoms being efficient in preventing the transition to psychiatric disease in primary care, reports on specific interventions are insufficient. Objective: This study aimed to verify the effectiveness of internet-delivered cognitive behavioral therapy (ICBT) for subthreshold depression (SD), subthreshold insomnia (SI), and subthreshold panic (SP). Additionally, this study aimed to explore the minimally important change (MIC) of each subthreshold group’s effectiveness outcome. Methods: Participants aged 18-70 years from internet research monitors were categorized into SD, SI, and SP groups based on screening assessment. They were randomly assigned to intervention or control groups within each subthreshold symptom. The intervention groups worked on 4 weeks of nonguided ICBT (“Mentre”), while the control groups worked on a sham app. The primary outcome was the score change from screening (T1) to 4-week follow-up (T4) using the Center for Epidemiologic Studies Depression Scale (CESD) in the SD group, the Pittsburgh Sleep Quality Index (PSQI) in the SI group, and the Panic and Agoraphobia Scale (PAS) in the SP group. Secondary outcomes were score changes in the Generalized Anxiety Disorder-7 (GAD-7) scale, the Patient Health Questionnaire 9 (PHQ-9), the CESD, the PSQI, and the PAS, except the primary outcome in each group. Secondary outcomes were analyzed using complete-case analysis and repeated-measures ANOVA. Additionally, the MIC in the primary endpoint for each group was also calculated as an exploratory outcome. Results: The SD, SP, and SI groups contained 846, 597, and 1106 participants, respectively. In the SD group, the difference in the CESD score change from baseline to follow-up between the intervention and control groups was significant (difference=0.52, 95% CI 1.29-4.66, P<.001). In the SI group, the difference in the PSQI score change was also significant (difference=0.53, 95% CI 0.11-0.94, P=.01). However, in the SP group, the difference in the PAS score change was not significant (difference=0.07, 95% CI –2.00 to 2.15, P=.94). Conclusions: Our ICBT program Mentre contributes to the improvement of SI and SD. This suggests that nonguided ICBT may be effective in preventing SI and SD from progressing to the full threshold. However, appropriate definitions of subthreshold symptoms are necessary. In particular, it is difficult to define SP, and further research that considers the specific factors of each subthreshold symptom is necessary to accumulate evidence. Trial Registration: University Hospital Medical Information Network (UMIN) UMIN000051280; https://tinyurl.com/2wyahhe3 %M 39899369 %R 10.2196/63139 %U https://formative.jmir.org/2025/1/e63139 %U https://doi.org/10.2196/63139 %U http://www.ncbi.nlm.nih.gov/pubmed/39899369 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e59653 %T Effectiveness of a Web-Based Self-Guided Intervention (MINDxYOU) for Reducing Stress and Promoting Mental Health Among Health Professionals: Results From a Stepped-Wedge Cluster Randomized Trial %A López-del-Hoyo,Yolanda %A Fernández-Martínez,Selene %A Perez-Aranda,Adrian %A Monreal-Bartolomé,Alicia %A Barceló-Soler,Alberto %A Camarero-Grados,Loreto %A Armas-Landaeta,Carilene %A Guzmán-Parra,José %A Carbonell,Vera %A Campos,Daniel %A Chen,Xinyuan %A García-Campayo,Javier %+ Department of Clinical and Health Psychology, Universitat Autònoma de Barcelona, Carrer de la Fortuna, s/n, Bellaterra, Barcelona, 08193, Spain, 34 935 81 18 55, adrian.peara@gmail.com %K eHealth %K health professionals %K stress %K mental health %K stress reduction %K web-based intervention %K stepped-wedge design %K randomized controlled trial %D 2025 %7 3.2.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: The high levels of sustained stress that health professionals often experience are a significant risk factor for developing mental health problems, such as anxiety, depression, and somatic symptoms, that not only affect their well-being but also have major social and organizational consequences. Different interventions, including those based on third-wave psychotherapy principles (ie, mindfulness, compassion, and acceptance), have proven to be effective in reducing stress in this population. Among them, those delivered on the web constitute a promising alternative with notable advantages in accessibility and flexibility, but some adherence inconveniences may limit their efficacy. Objective: This study aimed to evaluate the effectiveness of the MINDxYOU program, a web-based self-guided intervention based on third-wave psychotherapy principles, to reduce perceived stress and promote mental health in a sample of health professionals. Methods: In a stepped-wedge cluster randomized design, 357 health professionals from health centers in Aragon and Málaga, Spain, were recruited. They were divided into 6 clusters—3 per region—and randomly assigned to 1 of the 3 sequences, each starting with a control phase and then transitioning to the intervention phase (the MINDxYOU program) after 8, 16, or 24 weeks. This self-guided, web-based program, designed to be completed over 8 weeks, included weekly contact (via WhatsApp, call, or email) from the research team to promote adherence. Participants were assessed on the web every 8 weeks for 5 assessments. Perceived stress was the study’s primary outcome, with additional measures of clinical factors (anxiety, depression, and somatization) and process variables (resilience, mindfulness, compassion, and acceptance). Results: The program was initiated by 229 participants, 112 (48.9%) of whom were completers (ie, completed at least 3 of the 4 modules). Perceived stress demonstrated a significant reduction both when considering the entire sample (β=–1.08, SE 0.51; P=.03) and the sample of completers (β=–1.84, SE 0.62; P=.003). The proportion of participants reflecting “low stress” increased after the treatment (n=90, 46.6% vs n=100, 28.8% at baseline). Intracluster analysis revealed that pre- versus postintervention moderate effects were present in 2 clusters (Cohen d=0.46 and 0.62), and these were maintained in subsequent assessments. The linear mixed-effects models also showed that depression, anxiety, and somatization, as well as resilience, self-compassion, and some mindfulness facets, experienced significant improvements (P<.05) when comparing the intervention and control phases. Conclusions: The MINDxYOU program was effective in reducing perceived stress and promoting mental health, as well as increasing resilience, mindfulness facets, and self-compassion. These effects suggest that participants experienced a tangible improvement that could potentially enhance their well-being. Adherence to the intervention was moderate, while program use was notable compared to similar interventions. Finding ways to promote adherence to the intervention would contribute to increasing the effectiveness of this program. Trial Registration: ClinicalTrials.gov NCT05436717; https://clinicaltrials.gov/study/NCT05436717 International Registered Report Identifier (IRRID): RR2-10.1186/s12912-022-01089-5 %M 39899345 %R 10.2196/59653 %U https://www.jmir.org/2025/1/e59653 %U https://doi.org/10.2196/59653 %U http://www.ncbi.nlm.nih.gov/pubmed/39899345 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e69311 %T Evaluating the Impact of Pharmacotherapy in Augmenting Quit Rates Among Hispanic Adults in an App-Delivered Smoking Cessation Intervention: Secondary Analysis of a Randomized Controlled Trial %A Santiago-Torres,Margarita %A Mull,Kristin E %A Sullivan,Brianna M %A Cupertino,Ana Paula %A Salloum,Ramzi G %A Triplette,Matthew %A Zvolensky,Michael J %A Bricker,Jonathan B %+ Division of Public Health Sciences, Fred Hutchinson Cancer Center, 1100 Fairview Avenue North, Seattle, WA, 98109, United States, 1 206 667 4780, msantiag@fredhutch.org %K acceptance and commitment therapy %K Hispanic or Latino %K iCanQuit %K QuitGuide %K smartphone apps %K smoking cessation %K mobile phone %D 2025 %7 31.1.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Hispanic adults receive less advice to quit smoking and use fewer evidence-based smoking cessation treatments compared to their non-Hispanic counterparts. Digital smoking cessation interventions, such as those delivered via smartphone apps, provide a feasible and within-reach treatment option for Hispanic adults who smoke and want to quit smoking. While the combination of pharmacotherapy and behavioral interventions are considered best practices for smoking cessation, its efficacy among Hispanic adults, especially alongside smartphone app–based interventions, is uncertain. Objective: This secondary analysis used data from a randomized controlled trial that compared the efficacy of 2 smoking cessation apps, iCanQuit (based on acceptance and commitment therapy) and QuitGuide (following US clinical practice guidelines), to explore the association between pharmacotherapy use and smoking cessation outcomes among the subsample of 173 Hispanic participants who reported on pharmacotherapy use. Given the randomized design, we first tested the potential interaction of pharmacotherapy use and intervention arm on 12-month cigarette smoking abstinence. We then examined whether the use of any pharmacotherapy (ie, nicotine replacement therapy [NRT], varenicline, or bupropion) and NRT alone augmented each app-based intervention efficacy. Methods: Participants reported using pharmacotherapy on their own during the 3-month follow-up and cigarette smoking abstinence at the 12-month follow-up via web-based surveys. These data were used (1) to test the interaction effect of using pharmacotherapy to aid smoking cessation and intervention arm (iCanQuit vs QuitGuide) on smoking cessation at 12 months and (2) to test whether the use of pharmacotherapy to aid smoking cessation augmented the efficacy of each intervention arm to help participants successfully quit smoking. Results: The subsample of Hispanic participants was recruited from 30 US states. They were on average 34.5 (SD 9.3) years of age, 50.9% (88/173) were female, and 56.1% (97/173) reported smoking at least 10 cigarettes daily. Approximately 22% (38/173) of participants reported using pharmacotherapy to aid smoking cessation at the 3-month follow-up, including NRT, varenicline, or bupropion, with no difference between intervention arms. There was an interaction between pharmacotherapy use and intervention arm that marginally influenced 12-month quit rates at 12 months (P for interaction=.053). In the iCanQuit arm, 12-month missing-as-smoking quit rates were 43.8% (7/16) for pharmacotherapy users versus 28.8% (19/16) for nonusers (odds ratio 2.21, 95% CI 0.66-7.48; P=.20). In the QuitGuide arm, quit rates were 9.1% (2/22) for pharmacotherapy users versus 21.7% (15/69) for nonusers (odds ratio 0.36, 95% CI 0.07-1.72; P=.20). Results were similar for the use of NRT only. Conclusions: Combining pharmacotherapy to aid smoking cessation with a smartphone app–based behavioral intervention that teaches acceptance of cravings to smoke (iCanQuit) shows promise in improving quit rates among Hispanic adults. However, this combined approach was not effective with the US clinical guideline–based app (QuitGuide). Trial Registration: ClinicalTrials.gov NCT02724462; https://clinicaltrials.gov/study/NCT02724462 International Registered Report Identifier (IRRID): RR2-10.1001/jamainternmed.2020.4055 %R 10.2196/69311 %U https://formative.jmir.org/2025/1/e69311 %U https://doi.org/10.2196/69311 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e69771 %T An mHealth Intervention With Financial Incentives to Promote Smoking Cessation and Physical Activity Among Black Adults: Protocol for a Feasibility Randomized Controlled Trial %A Alexander,Adam %A Businelle,Michael %A Cheney,Marshall %A Cohn,Amy %A McNeill,Lorna %A Short,Kevin %A Frank-Pearce,Summer %A Bradley,David %A Estrada,Kimberly %A Flores,Iván %A Fronheiser,Jack %A Kendzor,Darla %+ University of Oklahoma Health Sciences Center, 655 Research Parkway, Suite 400, Oklahoma City, OK, 73104, United States, 1 (405) 965 05, Adam-Alexander@ouhsc.edu %K African American %K Black %K mobile health %K mHealth %K smartphone app %K smoking cessation %K physical activity, mobile phone %D 2025 %7 31.1.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Black adults in the United States experience disproportionately high rates of tobacco- and obesity-related diseases, driven in part by disparities in smoking cessation and physical activity. Smartphone-based interventions with financial incentives offer a scalable solution to address these health disparities. Objective: This study aims to assess the feasibility and preliminary efficacy of a mobile health intervention that provides financial incentives for smoking cessation and physical activity among Black adults. Methods: A total of 60 Black adults who smoke (≥5 cigarettes/d) and are insufficiently physically active (engaging in <150 min of weekly moderate-intensity physical activity) will be randomly assigned to either HealthyCells intervention (incentives for smoking abstinence only) or HealthyCells+ intervention (incentives for both smoking abstinence and daily step counts). Participants will use study-provided smartphones, smartwatches, and carbon monoxide monitors for 9 weeks (1 wk prequit date through 8 wk postquit date). Feasibility will be evaluated based on recruitment rates, retention, and engagement. The primary outcomes include carbon monoxide–verified, 7-day smoking abstinence at 8 weeks postquit date and changes in average daily step count. Feasibility benchmarks include a recruitment rate of ≥5 participants per month, a retention rate of ≥75%, and a smoking abstinence rate of ≥20% at 8 weeks postquit date. Expected increases in physical activity include a net gain of 500 to 1500 steps per day compared to baseline. Results: Recruitment is expected to begin in February 2025 and conclude by September 2025, with data analysis completed by October 2025. Conclusions: This study will evaluate the feasibility of a culturally tailored mobile health intervention combining financial incentives for smoking cessation and physical activity promotion. Findings will inform the design of larger-scale trials to address health disparities through scalable, technology-based approaches. Trial Registration: ClinicalTrials.gov NCT05188287; https://clinicaltrials.gov/ct2/show/NCT05188287 International Registered Report Identifier (IRRID): PRR1-10.2196/69771 %M 39888657 %R 10.2196/69771 %U https://www.researchprotocols.org/2025/1/e69771 %U https://doi.org/10.2196/69771 %U http://www.ncbi.nlm.nih.gov/pubmed/39888657 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e66045 %T Exploring the Users’ Perspective of the Nationwide Self-Exclusion Service for Gambling Disorder, “Spelpaus”: Qualitative Interview Study %A Tjernberg,Johanna %A Helgesson,Sara %A Håkansson,Anders %A Hansson,Helena %+ Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Psychiatry, Baravägen 1, Lund, 221 00, Sweden, 46 703135677, anders_c.hakansson@med.lu.se %K gambling disorder %K gambling addiction %K behavioral addiction %K harm reduction %K self-exclusion %K voluntary self-exclusion %K Spelpaus %K lived experience %K human factors %K usability %K qualitative study %D 2025 %7 31.1.2025 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Problem gambling and gambling disorder cause severe social, psychiatric, and financial consequences, and voluntary self-exclusion is a common harm reduction tool used by individuals with gambling problems. Objective: The aim of this study was to explore users’ experience of a novel nationwide, multioperator gambling self-exclusion service, “Spelpaus,” in Sweden and to inform stakeholders and policy makers in order to improve harm reduction tools against gambling problems. Methods: Semistructured interviews were conducted with 15 individuals who reported self-perceived gambling problems and who had experience of having used the self-exclusion service Spelpaus in Sweden. Interviews were transcribed and analyzed through qualitative content analysis. Results: We identified 3 categories and 8 subcategories. The categories were (1) reasons for the decision to self-exclude, (2) positive experiences, and (3) suggestions for improvement. The subcategories identified a number of reasons for self-exclusion, such as financial reasons and family reasons, and positive experiences described as a relief from gambling; in addition, important suggestions for improvement were cited, such as a more gradual return to gambling post–self-exclusion, better ways to address loopholes in the system, and transfer from self-exclusion to treatment. Conclusions: Voluntary self-exclusion from gambling, using a nationwide multioperator service, remains an appreciated harm-reducing tool. However, transfer from self-exclusion to treatment should be facilitated by policy making, and loopholes allowing for breaching of the self-exclusion need to be counteracted. %M 39888656 %R 10.2196/66045 %U https://humanfactors.jmir.org/2025/1/e66045 %U https://doi.org/10.2196/66045 %U http://www.ncbi.nlm.nih.gov/pubmed/39888656 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e65967 %T Examining Health Care Provider Experiences With Patient Portal Implementation: Mixed Methods Study %A Taneja,Shipra %A Kalia,Kamini %A Tang,Terence %A Wodchis,Walter P %A Vanderhout,Shelley %+ Trillium Health Partners, Institute for Better Health, 2085 Hurontario St, Mississauga, ON, L5B 1B8, Canada, 1 647 330 7192, shelley.vanderhout@thp.ca %K patient portal %K mixed methods %K implementation %K healthcare provider %K health system %K patient care %K online questionnaire %K Canada %K descriptive statistics %K thematic analysis %D 2025 %7 31.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Health systems are increasingly offering patient portals as tools for patients to access their health information with the goal of improving engagement in care. However, understanding health care providers’ perspectives on patient portal implementation is crucial. Objective: This study aimed to understand health care providers’ experiences of implementing the MyChart patient portal, perspectives about its impact on patient care, clinical practice, and workload, and opportunities for improvement. Methods: Using an explanatory sequential mixed methods approach, we conducted a web-based questionnaire and semistructured individual interviews with health care providers at a large Canadian community hospital, 6 months after MyChart was first offered to patients. We explored perspectives about the impact of MyChart on clinical practice, workload, and patient care. Data were analyzed using descriptive statistics and thematic analysis. Results: In total, 261 health care providers completed the web-based questionnaire, and 15 also participated in interviews. Participants agreed that patients should have access to their health information through MyChart and identified its benefits such as patients gaining a greater understanding of their own health, which could improve patient safety (160/255, 62%). While many health care providers agreed that MyChart supported better patient care (108/258, 42%), there was limited understanding of features available to patients and expectations for integrating MyChart into clinical routines. Concerns were raised about the potential negative impacts of MyChart on patient-provider relationships because sensitive notes or results could be inappropriately interpreted (109/251, 43%), and a potential increase in workload if additional portal features were introduced. Suggested opportunities for improvement included support for both patients and health care providers to learn about MyChart and establishing guidelines for health care providers on how to communicate information available in MyChart to patients. Conclusions: While health care providers acknowledged that MyChart improved patients’ access to health information, its implementation introduced some friction and concerns. To reduce the risk of these challenges, health systems can benefit from engaging health care providers early to identify effective patient portal implementation strategies. %M 39888658 %R 10.2196/65967 %U https://www.jmir.org/2025/1/e65967 %U https://doi.org/10.2196/65967 %U http://www.ncbi.nlm.nih.gov/pubmed/39888658 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e58164 %T Investigating the Efficacy of the Web-Based Common Elements Toolbox (COMET) Single-Session Interventions in Improving UK University Student Well-Being: Randomized Controlled Trial %A Lambert,Jeffrey %A Loades,Maria %A Marshall,Noah %A Higson-Sweeney,Nina %A Chan,Stella %A Mahmud,Arif %A Pile,Victoria %A Maity,Ananya %A Adam,Helena %A Sung,Beatrice %A Luximon,Melanie %A MacLennan,Keren %A Berry,Clio %A Chadwick,Paul %+ Department of Psychology, University of Bath, Claverton Down, Bath, BA2 7AY, United Kingdom, 44 1225 385249, m.e.loades@bath.ac.uk %K Common Elements Toolbox %K mental well-being %K online interventions %K single-session interventions %K university students %D 2025 %7 31.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Mental health problems in university students are associated with many negative outcomes, yet there is a gap between need and timely access to help. Single-session interventions (SSIs) are designed to be scalable and accessible, delivering core evidence-based intervention components within a one-off encounter. Objective: COMET (Common Elements Toolbox) is an online self-help SSI that includes behavioral activation, cognitive restructuring, gratitude, and self-compassion. COMET has previously been evaluated in India, Kenya, and the United States with promising results. This study tests the acceptability, appropriateness, perceived utility, and efficacy of COMET among UK university students during the peripandemic period. Methods: We conducted a randomized controlled trial evaluating the efficacy of COMET compared with a control group, with 2- and 4-week follow-ups. Outcome variables were subjective well-being, depression severity, anxiety severity, positive affect, negative affect, and perceived stress. We also measured intervention satisfaction immediately after completion of COMET. All UK university students with access to the internet were eligible to participate and were informed of the study online. The data were analyzed using linear mixed models and reported in accordance with the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online Telehealth) checklist. Results: Of the 831 people screened, 468 participants were randomized to a condition, 407 completed the postintervention survey, 147 returned the 2-week follow-up survey, 118 returned the 4-week follow-up survey, and 89 returned both. Of the 239 randomized, 212 completed COMET. Significant between-group differences in favor of the COMET intervention were observed at 2-week follow-ups for subjective well-being (Warwick-Edinburgh Mental Well-Being Scale; mean difference [MD] 1.39, 95% CI 0.19-2.61; P=.03), depression severity (9-item Patient Health Questionnaire; MD –1.31, 95% CI –2.51 to –0.12; P=.03), and perceived stress (4-item Perceived Stress Scale; MD –1.33, 95% CI –2.10 to –0.57; P<.001). Overall, participants were satisfied with COMET, with the majority endorsing the intervention and its modules as acceptable, appropriate, and exhibiting high utility. The self-compassion module was most often reported as the participants’ favorite module and the behavioral activation module was their least favorite. Qualitative analysis revealed that participants found COMET generally accessible, but too long, and experienced immediate and long-term beneficial effects. Conclusions: This study demonstrated high engagement with the COMET intervention, along with preliminary short-term efficacy. Almost all participants completed the intervention, but study attrition was high. Participant feedback indicated a high level of overall satisfaction with the intervention, with perceived accessibility, immediate benefits, and potential long-term impact being notable findings. These findings support the potential value of COMET as a mental health intervention and highlight important areas for further improvement. Trial Registration: ClinicalTrials.gov NCT05718141; https://clinicaltrials.gov/ct2/show/NCT05718141 %M 39888663 %R 10.2196/58164 %U https://www.jmir.org/2025/1/e58164 %U https://doi.org/10.2196/58164 %U http://www.ncbi.nlm.nih.gov/pubmed/39888663 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e64745 %T Increasing Access to Mental Health Supports for 18- to 25-Year-Old Indigenous Youth With the JoyPop Mobile Mental Health App: Study Protocol for a Randomized Controlled Trial %A MacIsaac,Angela %A Neufeld,Teagan %A Malik,Ishaq %A Toombs,Elaine %A Olthuis,Janine V %A Schmidt,Fred %A Dunning,Crystal %A Stasiuk,Kristine %A Bobinski,Tina %A Ohinmaa,Arto %A Stewart,Sherry H %A Newton,Amanda S %A Mushquash,Aislin R %+ Department of Psychology, Lakehead University, 955 Oliver Road, Thunder Bay, ON, P7B5E1, Canada, 1 8073438010 ext 8771, aislin.mushquash@lakeheadu.ca %K mental health %K youth %K Indigenous %K First Nations %K eHealth %K mHealth %K JoyPop %K protocol %K mobile mental health app %K mobile app %K Canada %K mobile health %K emotion regulation %D 2025 %7 30.1.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Transitional-aged youth have a high burden of mental health difficulties in Canada, with Indigenous youth, in particular, experiencing additional circumstances that challenge their well-being. Mobile health (mHealth) approaches hold promise for supporting individuals in areas with less access to services such as Northern Ontario. Objective: The primary objective of this study is to evaluate the effectiveness of the JoyPop app in increasing emotion regulation skills for Indigenous transitional-aged youth (aged 18-25 years) on a waitlist for mental health services when compared with usual practice (UP). The secondary objectives are to (1) evaluate the impact of the app on general mental health symptoms and treatment readiness and (2) evaluate whether using the app is associated with a reduction in the use (and therefore cost) of other services while one is waiting for mental health services. Methods: The study is a pragmatic, parallel-arm randomized controlled superiority trial design spanning a 4-week period. All participants will receive UP, which involves waitlist monitoring practices at the study site, which includes regular check-in phone calls to obtain any updates regarding functioning. Participants will be allocated to the intervention (JoyPop+UP) or control (UP) condition in a 1:1 ratio using stratified block randomization. Participants will complete self-report measures of emotion regulation (primary outcome), mental health, treatment readiness, and service use during 3 assessments (baseline, second [after 2 weeks], and third [after 4 weeks]). Descriptive statistics pertaining to baseline variables and app usage will be reported. Linear mixed modeling will be used to analyze change in outcomes over time as a function of condition assignment, while a cost-consequence analysis will be used to evaluate the association between app use and service use. Results: Recruitment began September 1, 2023, and is ongoing. In total, 2 participants have completed the study. Conclusions: This study will assess whether the JoyPop app is effective for Indigenous transitional-aged youth on a waitlist for mental health services. Positive findings may support the integration of the app into mental health services as a waitlist management tool. Trial Registration: ClinicalTrials.gov NCT05991154; https://clinicaltrials.gov/study/NCT05991154 International Registered Report Identifier (IRRID): DERR1-10.2196/64745 %M 39883939 %R 10.2196/64745 %U https://www.researchprotocols.org/2025/1/e64745 %U https://doi.org/10.2196/64745 %U http://www.ncbi.nlm.nih.gov/pubmed/39883939 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e58774 %T Families’ Experiences With Family-Focused Web-Based Interventions for Improving Health: Qualitative Systematic Literature Review %A Zhu,Diana %A Dordevic,Aimee L %A Davidson,Zoe E %A Gibson,Simone %+ Department of Nutrition Dietetics and Food, Monash University, 264 Ferntree Gully Rd, Level 1, Melbourne, 3168, Australia, 61 3 9902 4270, diana.zhu@monash.edu %K eHealth %K family based %K qualitative %K pediatric health %K internet %K mobile phone %D 2025 %7 30.1.2025 %9 Review %J J Med Internet Res %G English %X Background: eHealth interventions can favorably impact health outcomes and encourage health-promoting behaviors in children. More insight is needed from the perspective of children and their families regarding eHealth interventions, including features influencing program effectiveness. Objective: This review aimed to explore families’ experiences with family-focused web-based interventions for improving health. Methods: Five databases were searched on October 26, 2022—updated on October 24, 2023—for studies reporting qualitative data on participating children or their caregivers’ experiences with web-based programs. Study identification was performed in duplicate and studies were independently appraised for quality. Thematic synthesis was undertaken on qualitative data extracted from the results section of each included article. Results: Of 5524 articles identified, 28 articles were included. The studies examined the experiences of school-aged children (aged 5-18 years) and their caregivers (mostly mothers) with 26 web-based interventions that were developed to manage 17 different health conditions or influence health-supporting behaviors. Six themes were identified on families’ experiences: connecting with others, agency of learning, program reputability or credibility, program flexibility, meeting participants’ needs regarding program content or delivery, and impact on lifestyle. Conclusions: Families positively perceived family-focused web-based interventions, finding value in quality connections and experiencing social support; intervention features aligned with behavioral and self-management principles. Key considerations were highlighted for program developers and health care professionals on ways to adapt eHealth elements to meet families’ health-related needs. Continued research examining families’ experiences with eHealth interventions is needed, including the experiences of families from diverse populations and distinguishing the perspectives of children, their caregivers, and other family members, to inform the expansion of family-focused eHealth interventions in health care systems. Trial Registration: PROSPERO CRD42022363874; https://tinyurl.com/3xxa8enz %M 39883928 %R 10.2196/58774 %U https://www.jmir.org/2025/1/e58774 %U https://doi.org/10.2196/58774 %U http://www.ncbi.nlm.nih.gov/pubmed/39883928 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e57208 %T Co-Designing a Digital Brief Intervention to Reduce the Risk of Prescription Opioid–Related Harm Among People With Chronic Noncancer Pain: Qualitative Analysis of Patient Lived Experiences %A Elphinston,Rachel A %A Pager,Sue %A Brown,Kelly %A Sterling,Michele %A Fatehi,Farhad %A Gray,Paul %A Hipper,Linda %A Cahill,Lauren %A Connor,Jason P. %+ RECOVER Injury Research Centre, The University of Queensland, Level 7, 296 Herston Road, Herston, 4006, Australia, 61 412662084, rachelel@uq.edu.au %K chronic noncancer pain %K prescription opioid use %K brief intervention %K co-design %K patient partners %K lived experience %K qualitative %K digital health %D 2025 %7 30.1.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Opioid medications are important for pain management, but many patients progress to unsafe medication use. With few personalized and accessible behavioral treatment options to reduce potential opioid-related harm, new and innovative patient-centered approaches are urgently needed to fill this gap. Objective: This study involved the first phase of co-designing a digital brief intervention to reduce the risk of opioid-related harm by investigating the lived experience of chronic noncancer pain (CNCP) in treatment-seeking patients, with a particular focus on opioid therapy experiences. Methods: Eligible patients were those aged between 18 and 70 years with CNCP at a clinically significant level of intensity (a score of ≥4 of 10). Purposive sampling was used to engage patients on public hospital waitlists via mail or through the treating medical specialist. Participants (N=18; n=10 women; mean age 49.5 years, SD 11.50) completed semistructured telephone interviews. Interviews were transcribed verbatim, thematically analyzed using grounded theory, and member checked by patients. Results: Eight overarching themes were found, listed in the order of their prominence from most to least prominent: limited treatment collaboration and partnership; limited biopsychosocial understanding of pain; continued opioid use when benefits do not outweigh harms; a trial-and-error approach to opioid use; cycles of hopefulness and hopelessness; diagnostic uncertainty; significant negative impacts tied to loss; and complexity of pain and opioid use journeys. Conclusions: The findings of this study advance progress in co-designing digital brief interventions by actively engaging patient partners in their lived experiences of chronic pain and use of prescription opioid medications. The key recommendations proposed should guide the development of personalized solutions to address the complex care needs of patients with CNCP. %M 39883931 %R 10.2196/57208 %U https://formative.jmir.org/2025/1/e57208 %U https://doi.org/10.2196/57208 %U http://www.ncbi.nlm.nih.gov/pubmed/39883931 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e54392 %T Web-Based Exercise and Nutrition Intervention to Improve Leg Muscle Strength and Physical Functioning in Older Adults: Pre-Post Pilot Study %A Dorhout,Berber Gijsbertha %A Wezenbeek,Nick %A de Groot,Lisette C P G M %A Grootswagers,Pol %K web-based lifestyle intervention %K resistance exercise %K protein intake %K muscle strength %K muscle mass %K older adults %K web-based exercise %K nutrition %K exercise %K resistance training %K sarcopenia %D 2025 %7 30.1.2025 %9 %J JMIR Form Res %G English %X Background: The lifestyle intervention ProMuscle, which combines resistance exercise and an increased protein intake, was effective in improving muscle strength, muscle mass, and physical functioning in older adults. However, due to a growing shortage of health care professionals, the rapidly growing aging population cannot be personally guided in the future. Therefore, Uni2Move, a scalable web-based variant of ProMuscle, was designed to reach larger groups of older adults without putting additional burden on health care professionals. Objective: The current study investigated the effects of a web-based lifestyle intervention on muscle strength, protein intake, and physical functioning in healthy older adults. In addition, we conducted a qualitative study to gather key insights of the participants involved, as little is known about older adults’ perceptions of web-based lifestyle interventions. Methods: A pre-post pilot study was conducted in the Netherlands. In the 24-week intervention, 19 healthy adults aged >55 years were included. They performed resistance training at home twice a week for 24 weeks via web-based workout videos. Videos (45‐60 minutes) were recorded by the fitness trainer and mainly focused on training leg muscles. In addition, older adults were advised on increasing protein intake via two web-based consultations by a dietitian in the first 12 weeks and via an e-learning course in the second 12 weeks. Intervention adherence and acceptance was measured in week 25. The 1 repetition maximum knee extension strength, repeated chair rise test, and protein intake were measured at baseline, week 13, and week 25. Linear mixed models were used to test differences over time. Semistructured interviews were used to gather experiences of participants. Atlas.ti version 22 was used to analyze the interviews. Results: The mean age of participants (n=19) at baseline was 69 (SD 7) years. The 1 repetition maximum knee extension strength and repeated chair rise test improved significantly during the 24-week intervention with a mean difference of 7.0 kg (95% CI 4.8-9.3; P<.001) and −1.2 seconds (95% CI −1.7 to −0.6; P<.001), respectively. Total protein intake per day did not change, whereas protein intake during breakfast had increased significantly after 13 weeks with a mean difference of 6.9 g (95% CI 1.1-12.7; P=.01). Qualitative research revealed that advantages of the program included no need to travel and exercising in their own environment. Disadvantages were the lack of physical interaction and no corrections by the trainer. Conclusions: The results of the web-based exercise and nutrition intervention Uni2Move indicate potential improvements of muscle strength and physical functioning in healthy middle-aged and older adults. Providing such lifestyle interventions on the internet could reach an increased number of older adults, providing the opportunity to contribute to the health and independence of the rapidly growing aging population. %R 10.2196/54392 %U https://formative.jmir.org/2025/1/e54392 %U https://doi.org/10.2196/54392 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e63975 %T Effectiveness of Different Intervention Modes in Lifestyle Intervention for the Prevention of Type 2 Diabetes and the Reversion to Normoglycemia in Adults With Prediabetes: Systematic Review and Meta-Analysis of Randomized Controlled Trials %A Wang,Yachen %A Chai,Xin %A Wang,Yueqing %A Yin,Xuejun %A Huang,Xinying %A Gong,Qiuhong %A Zhang,Juan %A Shao,Ruitai %A Li,Guangwei %+ School of Population Medicine and Public Health, Chinese Academy of Medical Sciences & Peking Union Medical College, 31 Yard, Beijige Santiao, Dongcheng District, Beijing, China, Beijing, 100730, China, 86 13911644595, shaoruitai@sph.pumc.edu.cn %K mobile phone %K prediabetic state %K digital health intervention %K intervention mode %K lifestyle intervention %K type 2 diabetes mellitus %K meta-analysis %K systematic review %K review %D 2025 %7 29.1.2025 %9 Review %J J Med Internet Res %G English %X Background: Lifestyle interventions have been acknowledged as effective strategies for preventing type 2 diabetes mellitus (T2DM). However, the accessibility of conventional face-to-face interventions is often limited. Digital health intervention has been suggested as a potential solution to overcome the limitation. Despite this, there remains a significant gap in understanding the effectiveness of digital health for individuals with prediabetes, particularly in reducing T2DM incidence and reverting to normoglycemia. Objective: This study aimed to assess the effectiveness of different intervention modes of digital health, face-to-face, and blended interventions, particularly the benefits of digital health intervention, in reducing T2DM incidence and facilitating the reversion to normoglycemia in adults with prediabetes compared to the usual care. Methods: We conducted a comprehensive search in 9 electronic databases, namely MEDLINE, Embase, ACP Journal Club, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Cochrane Clinical Answers, Cochrane Methodology Register, Health Technology Assessment, and NHS Economic Evaluation Database through Ovid, from the inception to October 2024. This review included randomized controlled trials (RCTs) that studied the effectiveness of lifestyle interventions in adults with prediabetes. The overall intervention effect was synthesized using a random-effects model. The I² statistic was used to assess heterogeneity across the RCTs. We performed a subgroup analysis to explore the effectiveness of digital health, face-to-face, and blended interventions compared with the control group, which received usual care. Results: From an initial 7868 records retrieved from 9 databases, we identified 54 articles from 31 RCTs. Our analysis showed that face-to-face interventions demonstrated a significant 46% risk reduction in T2DM incidence (risk ratio [RR] 0.54, 95% CI 0.47-0.63; I²=43%; P<.001), and a 46% increase in the reversion to normoglycemia (RR 1.46, 95% CI 1.11-1.91; I²=82%; P=.006), when compared with the control group. On the other hand, digital health interventions, compared with the control group, were associated with a 12% risk reduction in T2DM incidence (RR 0.88, 95% CI 0.77-1.01; I²=0.6%; P=.06). Moreover, the blended interventions combining digital and face-to-face interventions suggested a 37% risk reduction in T2DM incidence (RR 0.63, 95% CI 0.49-0.81;I²<0.01%; P<.001) and an 87% increase in the reversion to normoglycemia (RR 1.87, 95% CI 1.30-2.69; I²=23%; P=.001). However, no significant effect on the reversal of prediabetes to normoglycemia was observed from the digital health interventions. Conclusions: Face-to-face interventions have consistently demonstrated promising effectiveness in both reductions in T2DM incidence and reversion to normoglycemia in adults with prediabetes. However, the effectiveness of digital health interventions in these areas has not been sufficiently proven. Given these results, further research is required to provide more definitive evidence of digital health and blended interventions in T2DM prevention in the future. Trial Registration: PROSPERO CRD42023414313; https://tinyurl.com/55ac4j4n %M 39879607 %R 10.2196/63975 %U https://www.jmir.org/2025/1/e63975 %U https://doi.org/10.2196/63975 %U http://www.ncbi.nlm.nih.gov/pubmed/39879607 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 12 %N %P e65222 %T Testing the Feasibility, Acceptability, and Potential Efficacy of an Innovative Digital Mental Health Care Delivery Model Designed to Increase Access to Care: Open Trial of the Digital Clinic %A Macrynikola,Natalia %A Chen,Kelly %A Lane,Erlend %A Nguyen,Nic %A Pinto,Jennifer %A Yen,Shirley %A Torous,John %+ Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States, 1 617 667 4735, jtorous@bidmc.harvard.edu %K digital interventions %K transdiagnostic treatment %K evidence-based treatment %K digital navigator %K access to care %K mobile phone %D 2025 %7 29.1.2025 %9 Original Paper %J JMIR Ment Health %G English %X Background: Mental health concerns have become increasingly prevalent; however, care remains inaccessible to many. While digital mental health interventions offer a promising solution, self-help and even coached apps have not fully addressed the challenge. There is now a growing interest in hybrid, or blended, care approaches that use apps as tools to augment, rather than to entirely guide, care. The Digital Clinic is one such model, designed to increase access to high-quality mental health services. Objective: To assess the feasibility, acceptability, and potential efficacy of the Digital Clinic model, this study aims to conduct a nonrandomized open trial with participants experiencing depression, anxiety, or both, at various levels of clinical severity. Methods: Clinicians were trained in conducting brief transdiagnostic evidence-based treatment augmented by a mental health app (mindLAMP); digital navigators were trained in supporting participants’ app engagement and digital literacy while also sharing app data with both patients and clinicians. Feasibility and acceptability of this 8-week program were assessed against a range of benchmarks. Potential efficacy was assessed by calculating pre-post change in symptoms of depression (Patient Health Questionnaire-9; PHQ-9), anxiety (7-item Generalized Anxiety Disorder; GAD-7), and comorbid depression and anxiety (Patient Health Questionnaire Anxiety and Depression Scale; PHQ-ADS), as well as rates of clinically meaningful improvement and remission. Secondary outcomes included change in functional impairment, self-efficacy in managing emotions, and flourishing. Results: Of the 258 enrolled participants, 215 (83.3%) completed the 8-week program. Most were White (n=151, 70.2%) and identified as cisgender women (n=136, 63.3%), with a mean age of 41 (SD 14) years. Feasibility and acceptability were good to excellent across a range of domains. The program demonstrated potential efficacy: the average PHQ-9 score was moderate to moderately severe at baseline (mean 13.39, SD 4.53) and decreased to subclinical (mean 7.79, SD 4.61) by the end of the intervention (t126=12.50, P<.001, Cohen d=1.11). Similarly, the average GAD-7 score decreased from moderate at baseline (mean 12.93, SD 3.67) to subclinical (mean 7.35, SD 4.19) by the end of the intervention (t113=13, P<.001, Cohen d=1.22). Participation in the program was also associated with high rates of clinically significant improvement and remission. Conclusions: Results suggest that the Digital Clinic model is feasible, acceptable, and potentially efficacious, warranting a future randomized controlled trial to establish the efficacy of this innovative model of care. %M 39879612 %R 10.2196/65222 %U https://mental.jmir.org/2025/1/e65222 %U https://doi.org/10.2196/65222 %U http://www.ncbi.nlm.nih.gov/pubmed/39879612 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e67171 %T Engagement With an Internet-Administered, Guided, Low-Intensity Cognitive Behavioral Therapy Intervention for Parents of Children Treated for Cancer: Analysis of Log-Data From the ENGAGE Feasibility Trial %A Reuther,Christina %A von Essen,Louise %A Mustafa,Mudassir Imran %A Saarijärvi,Markus %A Woodford,Joanne %+ CIRCLE - Complex Intervention Research in Health and Care, Department of Women's and Children's Health, Uppsala University, Dag Hammarskjölds 14B, Uppsala, 75237, Sweden, 46 70 425 07 14, louise-von.essen@uu.se %K childhood cancer survivor %K cognitive behavioral therapy %K engagement %K internet-administered intervention %K log-data %K parents %D 2025 %7 28.1.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Parents of children treated for cancer may experience psychological difficulties including depression, anxiety, and posttraumatic stress. Digital interventions, such as internet-administered cognitive behavioral therapy, offer an accessible and flexible means to support parents. However, engagement with and adherence to digital interventions remain a significant challenge, potentially limiting efficacy. Understanding factors influencing user engagement and adherence is crucial for enhancing the acceptability, feasibility, and efficacy of these interventions. We developed an internet-administered, guided, low-intensity cognitive behavioral therapy (LICBT)–based self-help intervention for parents of children treated for cancer, (EJDeR [internetbaserad självhjälp för föräldrar till barn som avslutat en behandling mot cancer or internet-based self-help for parents of children who have completed cancer treatment]). EJDeR included 2 LICBT techniques—behavioral activation and worry management. Subsequently, we conducted the ENGAGE feasibility trial and EJDeR was found to be acceptable and feasible. However, intervention adherence rates were marginally under progression criteria. Objective: This study aimed to (1) describe user engagement with the EJDeR intervention and examine whether (2) sociodemographic characteristics differed between adherers and nonadherers, (3) depression and anxiety scores differed between adherers and nonadherers at baseline, (4) user engagement differed between adherers and nonadherers, and (5) user engagement differed between fathers and mothers. Methods: We performed a secondary analysis of ENGAGE data, including 71 participants. User engagement data were collected through log-data tracking, for example, communication with e-therapists, homework submissions, log-ins, minutes working with EJDeR, and modules completed. Chi-square tests examined differences between adherers and nonadherers and fathers and mothers concerning categorical data. Independent-samples t tests examined differences regarding continuous variables. Results: Module completion rates were higher among those who worked with behavioral activation as their first LICBT module versus worry management. Of the 20 nonadherers who opened the first LICBT module allocated, 30% (n=6) opened behavioral activation and 70% (n=14) opened worry management. No significant differences in sociodemographic characteristics were found. Nonadherers who opened behavioral activation as the first LICBT module allocated had a significantly higher level of depression symptoms at baseline than adherers. No other differences in depression and anxiety scores between adherers and nonadherers were found. Minutes working with EJDeR, number of log-ins, days using EJDeR, number of written messages sent to e-therapists, number of written messages sent to participants, and total number of homework exercises submitted were significantly higher among adherers than among nonadherers. There were no significant differences between fathers and mothers regarding user engagement variables. Conclusions: Straightforward techniques, such as behavioral activation, may be well-suited for digital delivery, and more complex techniques, such as worry management, may require modifications to improve user engagement. User engagement was measured behaviorally, for example, through log-data tracking, and future research should measure emotional and cognitive components of engagement. Trial Registration: ISRCTN Registry 57233429; https://doi.org/10.1186/ISRCTN57233429 %M 39874575 %R 10.2196/67171 %U https://formative.jmir.org/2025/1/e67171 %U https://doi.org/10.2196/67171 %U http://www.ncbi.nlm.nih.gov/pubmed/39874575 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e59461 %T Feasibility of a Mobile App–Based Cognitive-Behavioral Perinatal Skills Program: Protocol for Nonrandomized Pilot Trial %A Temkin-Yu,Andrea B %A Ayaz,Aliza %A Blicker,Ella %A Liu,Michael X %A Oh,Ace %A Siegel,Isabelle E %A Seewald,Meredith J %A Hermann,Alison D %A Givrad,Soudebah %A Baez,Lara M %A Osborne,Lauren M %A Green,Cori M %A Schier,Maddy M %A Davis,Alexandra M %A Zhu,Shasha %A Falk,Avital %A Bennett,Shannon M %+ Psychiatry Department, Weill Cornell Medicine, 525 E 68th Street, New York, NY, 10065, United States, 1 6402038301, andreabtemkin@gmail.com %K perinatal mood and anxiety disorders %K apps %K smartphones %K digital intervention %K cognitive behavioral therapy %K feasibility %K pilot trial %K mobile phones %D 2025 %7 28.1.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Mental illness is one of the top causes of preventable pregnancy-related deaths in the United States. There are many barriers that interfere with the ability of perinatal individuals to access traditional mental health care. Digital health interventions, including app-based programs, have the potential to increase access to useful tools for these individuals. Although numerous mental health apps exist, there is little research on developing programs to address the unique needs of perinatal individuals. In an effort to fill this gap, a multidisciplinary team of experts in psychology, psychiatry, obstetrics, and pediatric primary care collaborated to develop the novel Perinatal Skills Program within Maya, a flexible and customizable cognitive-behavioral skills app. Maya-Perinatal Skills Program (M-PSP) uses evidence-based strategies to help individuals manage their mood and anxiety symptoms during pregnancy and post partum. Objective: This pilot study aims to assess the feasibility, acceptability, and usability of M-PSP and explore links between program use and symptoms of anxiety and low mood. Methods: This single-arm trial will recruit 50 pregnant or postpartum individuals with mild-to-moderate anxiety or mood symptoms. Participants will be recruited from a variety of public and private insurance-based psychiatry, obstetrics, and primary care clinics at a large academic medical center located in New York City. Participants will complete all sessions of M-PSP and provide feedback. Outcome measures will include qualitative and quantitative assessments of feasibility, acceptability, and usability, passively collected program usage data, and symptom measures assessing mood, anxiety, and trauma. Planned data analysis includes the use of the grounded theory approach to identify common themes in qualitative feedback, as well as an exploration of possible associations between quantitative data regarding program use and symptoms. Results: The recruitment began on August 2023. As of October 2024, a total of 32 participants have been enrolled. The recruitment will continue until 50 participants have been enrolled. Conclusions: Digital health interventions, like M-PSP, have the potential to create new pathways to reach individuals struggling with their mental health. The results of this study will be the groundwork for future iterations of M-PSP in the hopes of providing an accessible and helpful tool for pregnant and postpartum individuals. Trial Registration: ClinicalTrials.gov NCT05897619; https://classic.clinicaltrials.gov/ct2/show/NCT05897619 International Registered Report Identifier (IRRID): PRR1-10.2196/59461 %M 39874578 %R 10.2196/59461 %U https://www.researchprotocols.org/2025/1/e59461 %U https://doi.org/10.2196/59461 %U http://www.ncbi.nlm.nih.gov/pubmed/39874578 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e54790 %T Rehabilomics Strategies Enabled by Cloud-Based Rehabilitation: Scoping Review %A Oh,Sejun %A Lee,SangHeon %+ Department of Physical Medicine and Rehabilitation, Korea University Anam Hospital, 145, Anam-Ro, Seongbuk-Gu, Seoul, 02841, Republic of Korea, 82 2286 1419, rmlsh@korea.ac.kr %K cloud-based %K health %K rehabilitation %K rehabilomics %K strategies %D 2025 %7 28.1.2025 %9 Review %J J Med Internet Res %G English %X Background: Rehabilomics, or the integration of rehabilitation with genomics, proteomics, metabolomics, and other “-omics” fields, aims to promote personalized approaches to rehabilitation care. Cloud-based rehabilitation offers streamlined patient data management and sharing and could potentially play a significant role in advancing rehabilomics research. This study explored the current status and potential benefits of implementing rehabilomics strategies through cloud-based rehabilitation. Objective: This scoping review aimed to investigate the implementation of rehabilomics strategies through cloud-based rehabilitation and summarize the current state of knowledge within the research domain. This analysis aims to understand the impact of cloud platforms on the field of rehabilomics and provide insights into future research directions. Methods: In this scoping review, we systematically searched major academic databases, including CINAHL, Embase, Google Scholar, PubMed, MEDLINE, ScienceDirect, Scopus, and Web of Science to identify relevant studies and apply predefined inclusion criteria to select appropriate studies. Subsequently, we analyzed 28 selected papers to identify trends and insights regarding cloud-based rehabilitation and rehabilomics within this study’s landscape. Results: This study reports the various applications and outcomes of implementing rehabilomics strategies through cloud-based rehabilitation. In particular, a comprehensive analysis was conducted on 28 studies, including 16 (57%) focused on personalized rehabilitation and 12 (43%) on data security and privacy. The distribution of articles among the 28 studies based on specific keywords included 3 (11%) on the cloud, 4 (14%) on platforms, 4 (14%) on hospitals and rehabilitation centers, 5 (18%) on telehealth, 5 (18%) on home and community, and 7 (25%) on disease and disability. Cloud platforms offer new possibilities for data sharing and collaboration in rehabilomics research, underpinning a patient-centered approach and enhancing the development of personalized therapeutic strategies. Conclusions: This scoping review highlights the potential significance of cloud-based rehabilomics strategies in the field of rehabilitation. The use of cloud platforms is expected to strengthen patient-centered data management and collaboration, contributing to the advancement of innovative strategies and therapeutic developments in rehabilomics. %M 39874565 %R 10.2196/54790 %U https://www.jmir.org/2025/1/e54790 %U https://doi.org/10.2196/54790 %U http://www.ncbi.nlm.nih.gov/pubmed/39874565 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e59414 %T A Digital Tool (Technology-Assisted Problem Management Plus) for Lay Health Workers to Address Common Mental Health Disorders: Co-production and Usability Study in Pakistan %A Saleem,Maham %A Zafar,Shamsa %A Klein,Thomas %A Koesters,Markus %A Bashir,Adnan %A Fuhr,Daniela C %A Sikander,Siham %A Zeeb,Hajo %+ Leibniz Institute for Prevention Research and Epidemiology – BIPS, Achterstraße 30, Bremen, 28359, Germany, 49 421 218 ext 56760, saleem@leibniz-bips.de %K digital mental health %K digital technology %K digital intervention %K Problem Management Plus %K lay health worker programme %K common mental health disorders %K low- and middle-income countries %K co-production %D 2025 %7 28.1.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Mental health remains among the top 10 leading causes of disease burden globally, and there is a significant treatment gap due to limited resources, stigma, limited accessibility, and low perceived need for treatment. Problem Management Plus, a World Health Organization–endorsed brief psychological intervention for mental health disorders, has been shown to be effective and cost-effective in various countries globally but faces implementation challenges, such as quality control in training, supervision, and delivery. While digital technologies to foster mental health care have the potential to close treatment gaps and address the issues of quality control, their development requires context-specific, interdisciplinary, and participatory approaches to enhance impact and acceptance. Objective: We aimed to co-produce Technology-Assisted Problem Management Plus (TA-PM+) for "lady health workers" (LHWs; this is the terminology used by the Lady Health Worker Programme for lay health workers) to efficiently deliver sessions to women with symptoms of common mental health disorders within the community settings of Pakistan and conducted usability testing in community settings. Methods: A 3-stage framework was used for co-producing and prototyping the intervention. Stage 1 (evidence review and stakeholder consultation) included 3 focus group discussions with 32 LHWs and 7 in-depth interviews with key stakeholders working in the health system or at the health policy level. Thematic analyses using the Capability, Opportunity, and Motivation for Behavioral Change (COM-B) model were conducted. Stage 2 included over eight online workshops, and a multidisciplinary intervention development group co-produced TA-PM+. Stage 3 (prototyping) involved 2 usability testing rounds. In round 1 conducted in laboratory settings, 6 LHWs participated in role plays and completed the 15-item mHealth Usability App Questionnaire (MUAQ) (score range 0-7). In round 2 conducted in community settings, trained LHWs delivered the intervention to 6 participants screened for depression and anxiety. Data were collected using the MUAQ completed by LHWs and the Patient Satisfaction Questionnaire (PSQ) (score range 0-46) completed by participants. Results: Qualitative analysis indicated that a lack of digital skills among LHWs, high workload, resource scarcity for digitization (specifically internet bandwidth in the community), and need for comprehensive training were barriers for TA-PM+ implementation in the community through LHWs. Training, professional support, user guidance, an easy and automated interface, offline functionalities, incentives, and strong credibility among communities were perceived to enhance the capability, opportunity, and motivation of LHWs to implement TA-PM+. TA-PM+ was co-produced with features like an automated interface, a personal dashboard, guidance videos, and a connected supervisory panel. The mean MUAQ score was 5.62 in round 1 of usability testing and improved to 5.96 after incorporating LHW feedback in round 2. The mean PSQ score for TA-PM+ was 40 in round 2. Conclusions: Co-production of TA-PM+ for LHWs balanced context and evidence. The 3-stage iterative development approach resulted in high usability and acceptability of TA-PM+ for LHWs and participants. %M 39874072 %R 10.2196/59414 %U https://formative.jmir.org/2025/1/e59414 %U https://doi.org/10.2196/59414 %U http://www.ncbi.nlm.nih.gov/pubmed/39874072 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e64718 %T Internet-Based Dementia Prevention Intervention (DementiaRisk): Protocol for a Randomized Controlled Trial and Knowledge Translation %A Levinson,Anthony J %A Ayers,Stephanie %A Clark,Sandra %A Woodburn,Rebekah %A Dobbins,Maureen %A Duarte,Dante %A Grad,Roland %A Kates,Nick %A Marr,Sharon %A Oliver,Doug %A Papaioannou,Alexandra %A Saperson,Karen %A Siu,Henry %A Strudwick,Gillian %A Sztramko,Richard %A Neil-Sztramko,Sarah %+ McMaster University, 1280 Main Street West, Hamilton, ON, L8S4L8, Canada, 1 905 525 9140, levinsa@mcmaster.ca %K web-based intervention %K internet %K eHealth %K dementia risk %K dementia prevention %K Alzheimer disease %K education and training %K clinical trial %K knowledge translation %K public health %K health literacy %K e-learning %D 2025 %7 27.1.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Research has shown that engaging in a range of healthy lifestyles or behavioral factors can help reduce the risk of developing dementia. Improved knowledge of modifiable risk factors for dementia may help engage people to reduce their risk, with beneficial impacts on individual and public health. Moreover, many guidelines emphasize the importance of providing education and web-based resources for dementia prevention. Internet-based interventions may be effective, but few have been studied rigorously or widely disseminated. We created DementiaRisk, an award-winning, web- and email-based education platform for the public focused on modifiable risk factors, featuring multimedia e-learning and email “microlearning” content, to help raise awareness and improve knowledge of actions to reduce dementia risk. Objective: This protocol describes a randomized controlled trial to (1) evaluate whether exposure to DementiaRisk changes knowledge of dementia risk factors, intention to engage in risk reduction activities, and health behaviors related to dementia risk reduction and to (2) explore qualitative aspects including participants’ engagement and satisfaction with the intervention and barriers and facilitators to use. Methods: Using a sequential explanatory mixed methods design, this study conducts a quantitative analysis followed by a qualitative inquiry to evaluate outcomes and feasibility. In total, 485 participants will be recruited on the web and randomly assigned to 2 groups: one accessing DementiaRisk and the other receiving alternative e-learning on mild cognitive impairment. Assessments will be delivered on the web at baseline (T1), at 4 weeks (T2), and at 2 months after the intervention (T3). Knowledge will be assessed using items from the Dementia Knowledge Assessment Scale, intentions to engage in risk reduction activities will be assessed using items in line with current evidence, and health behaviors related to dementia risk reduction will be assessed using items from the Godin-Shephard Leisure Time Physical Activity Questionnaire along with additional questions related to a range of health status domains. Outcomes and feasibility will be assessed using the Information Assessment Method for patients and consumers. A linear mixed effects model will be used to examine the relationship between each outcome score by group and time point. Results: This study was approved by the Hamilton Integrated Research Ethics Board on August 24, 2022 (project ID 14886) and received funding in February 2023. Recruitment took place from March 28, 2023, to April 28, 2023, with the final participants completing the intervention by August 18, 2023. Analyses and interpretation of data are ongoing. Conclusions: DementiaRisk is a readily scalable, technology-enhanced solution for dementia prevention education. It has been designed using evidence-based principles of multimedia learning. It has the potential to scale and spread widely using the open internet, so it may be able to reach a wider audience than traditional in-person educational interventions. Trial Registration: ClinicalTrials.gov NCT05383118; https://clinicaltrials.gov/study/NCT05383118 International Registered Report Identifier (IRRID): DERR1-10.2196/64718 %M 39869903 %R 10.2196/64718 %U https://www.researchprotocols.org/2025/1/e64718 %U https://doi.org/10.2196/64718 %U http://www.ncbi.nlm.nih.gov/pubmed/39869903 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e63564 %T LoVE4MUM Mobile App to Prevent Postpartum Depression: Protocol for a Pilot Randomized Controlled Trial %A Kamarudin,Siti Sabrina %A Idris,Idayu Badilla %A Sharip,Shalisah %A Ahmad,Norfazilah %+ Department of Public Health Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak, Cheras, 56000, Malaysia, 60 91455887 ext 5888, idayubadilla.idris@ukm.edu.my %K postpartum depression %K mHealth intervention %K mobile phone %K prevention %K self-guided %K virtual engagement %K engagement %K maternal %K protocol %K randomized controlled trial %K postpartum %K depression %K maternal %K well-being %K mobile health %K preventive care %K mobile app %K mental health literacy %K postpartum care %D 2025 %7 27.1.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Postpartum depression remains a significant concern, posing substantial challenges to maternal well-being, infant health, and the mother-infant bond, particularly in the face of barriers to traditional support and interventions. Previous studies have shown that mobile health (mHealth) interventions offer an accessible means to facilitate early detection and management of mental health issues while at the same time promoting preventive care. Objective: This study aims to evaluate the effectiveness of the Leveraging on Virtual Engagement for Maternal Understanding & Mood-enhancement (LoVE4MUM) mobile app, which was developed based on the principles of cognitive behavioral therapy and psychoeducation and serves as an intervention to prevent postpartum depression. Methods: This single-blinded, pilot randomized controlled trial includes 64 mothers recruited from the postnatal ward and randomized using a 1:1 ratio to receive either postpartum care (treatment as usual) or postpartum care (treatment as usual) plus the self-guided LoVE4MUM mobile app. The primary outcome is the effectiveness of the mobile app at improving postpartum depression. Secondary outcomes are changes in the mental health literacy score and negative automatic thoughts, which are collected using a self-reported questionnaire. Results: Patient recruitment began on September 1, 2024. As of January 1, 2025, recruitment was successfully completed, with a total of 72 participants enrolled: 36 in the intervention group and 36 in the control group . The final results are anticipated to be available by March 2025, and publication is expected by the end of 2025. Conclusions: By examining the LoVE4MUM app alongside standard postpartum care, this pilot randomized controlled trial seeks to offer preliminary evidence on the potential of mHealth tools to improve maternal mental health as well as to reduce postpartum depression symptoms. The findings are expected to contribute to the future development of effective, accessible, and scalable interventions for mothers. Trial Registration: ClinicalTrials.gov NCT06366035; https://clinicaltrials.gov/study/NCT06366035 International Registered Report Identifier (IRRID): PRR1-10.2196/63564 %M 39869891 %R 10.2196/63564 %U https://www.researchprotocols.org/2025/1/e63564 %U https://doi.org/10.2196/63564 %U http://www.ncbi.nlm.nih.gov/pubmed/39869891 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e66715 %T Effectiveness of Video Teletherapy in Treating Obsessive-Compulsive Disorder in Children and Adolescents With Exposure and Response Prevention: Retrospective Longitudinal Observational Study %A Feusner,Jamie D %A Farrell,Nicholas R %A Nunez,Mia %A Lume,Nicholas %A MacDonald,Catherine W %A McGrath,Patrick B %A Trusky,Larry %A Smith,Stephen %A Rhode,Andreas %+ NOCD, Inc, 225 N Michigan Ave Suite 1430, Chicago, IL, 60601, United States, jamie@nocdhelp.com %K digital behavioral health %K youth %K cognitive-behavioral therapy %K exposure and response prevention %K CBT %K ERP %K OCD %K psychiatry %K clinical trial %K psychology %K video therapy %K teletherapy %K e-therapy %K e-counseling %K cyber-counseling %K adolescents %K adolescence %K obsessive-compulsive disorder %K retrospective study %K longitudinal study %K observational study %K ERP therapy %D 2025 %7 27.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: An effective primary treatment for obsessive-compulsive disorder (OCD) in children and adolescents as well as adults is exposure and response prevention (ERP), a form of intervention in the context of cognitive-behavioral therapy. Despite strong evidence supporting the efficacy and effectiveness of ERP from studies in research and real-world settings, its clinical use remains limited. This underuse is often attributed to access barriers such as the scarcity of properly trained therapists, geographical constraints, and costs. Some of these barriers may be addressed with virtual behavioral health, providing ERP for OCD through video teletherapy and supplemented by app-based therapeutic tools and messaging support between sessions. Studies of teletherapy ERP in adults with OCD have shown benefits in research and real-world settings in both small and large samples. However, studies of teletherapy ERP in children and adolescents thus far have been in small samples and limited to research rather than real-world settings. Objective: This study reports on the real-world effectiveness of teletherapy ERP for OCD in the largest sample (N=2173) of child and adolescent patients to date. Methods: Children and adolescents with OCD were treated with live, face-to-face video teletherapy sessions, with parent or caregiver involvement, using ERP. Assessments were conducted at baseline, after 7-11 weeks, and after 13-17 weeks. Additionally, longitudinal assessments of OCD symptoms were performed at weeks 18-30, 31-42, and 43-54. We analyzed longitudinal outcomes of OCD symptoms, depression, anxiety, and stress using linear mixed models. Results: Treatment resulted in a median 38.46% (IQR 12.50%-64.00%) decrease in OCD symptoms at 13-17 weeks, and 53.4% of youth met full response criteria at this point. Improvements were observed in all categories of starting symptom severity: mild (median 40.3%, IQR 8.5%-79.8%), moderate (median 38.4%, IQR 13.3%-63.6%), and severe (median 34.1%, IQR 6.6%-58.5%). In addition, there were significant reductions in the severity of depression, anxiety, and stress symptoms. The median amount of therapist involvement was 13 (IQR 10.0-16.0) appointments and 11.5 (IQR 9.0-15.0) hours. Further, symptom improvements were maintained or improved upon in the longitudinal assessment periods of weeks 18-30, 31-42, and 43-54. Conclusions: These results show that remote ERP treatment, assisted by technology, can effectively improve both core OCD and related depression, anxiety, and stress symptoms in children and adolescents with OCD in a real-world setting. Notable outcomes were achieved in a relatively small amount of therapist time, demonstrating its efficiency. Demonstrating the usefulness of a delivery format that overcomes several traditional barriers to treatment, these findings have implications for widespread dissemination of accessible, evidence-based care for children and adolescents with OCD. %M 39869894 %R 10.2196/66715 %U https://www.jmir.org/2025/1/e66715 %U https://doi.org/10.2196/66715 %U http://www.ncbi.nlm.nih.gov/pubmed/39869894 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e67846 %T A 4-Week Mobile App–Based Telerehabilitation Program vs Conventional In-Person Rehabilitation in Older Adults With Sarcopenia: Randomized Controlled Trial %A Zhang,Lu %A Ge,Ying %A Zhao,Wowa %A Shu,Xuan %A Kang,Lin %A Wang,Qiumei %A Liu,Ying %+ Department of Rehabilitation Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 1, Shuai Fu Yuan Hutong, Dongcheng District, Beijing, 100730, China, 86 18612671468, pumch9887@163.com %K telerehabilitation %K elderly %K sarcopenia %K resistance exercise %K rehabilitation %K gerontology %K aging %K randomized controlled trial %K rehabilitation training %K body composition %K strength %K balance %K cardiorespiratory endurance %K self-care %K physical therapy %D 2025 %7 24.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Sarcopenia is closely associated with a poor quality of life and mortality, and its prevention and treatment represent a critical area of research. Resistance training is an effective treatment for older adults with sarcopenia. However, they often face challenges when receiving traditional rehabilitation treatments at hospitals. Objective: We aimed to compare the effects of a digital rehabilitation program with those of traditional therapist-supervised rehabilitation training on older adults with sarcopenia. Methods: In total, 58 older adults with sarcopenia were recruited offline and randomized (1:1) into 2 groups: the telerehabilitation group (TRG, n=29, 50%) and the in-person rehabilitation group (IRG, n=29, 50%). Both groups underwent 4-week resistance training targeting 6 major muscle groups. The TRG received exercise guidance via a mobile app, while the IRG received in-person training from a therapist. Offline assessments of body composition, grip strength, and balance using the 30-Second Arm Curl Test (30SACT), 30-Second Sitting-to-Rising Test (30SSRT), quadriceps femoris extension peak torque (EPT) and extension total power (ETP), Berg Balance Scale (BBS), Timed Up-and-Go Test (TUGT), 6-Minute Walk Test (6MWT), and Instrumental Activities of Daily Living (IADL) scale, were conducted before and after the intervention. Results: Of the 58 patients, 51 (88%; TRG: n=24, 47%; IRG: n=27, 53%) completed the trial. After 4 weeks of intervention, the mean grip strength increased from 18.10 (SD 5.56) to 19.92 (SD 5.90) kg in the TRG (P=.02) and from 18.59 (SD 5.95) to 19.59 (SD 6.11) kg in the IRG (P=.01). The 30SACT and 30SSRT scores increased from 12.48 (SD 2.68) to 14.94 (SD 3.68) times (P=.01) and from 15.16 (SD 7.23) to 16.58 (SD 8.42) times (P=.045), respectively, in the TRG and from 12.25 (SD 4.19) to 14.68 (SD 4.36) times (P=.003) and from 14.31 (SD 4.04) to 16.25 (SD 4.91) times (P=.01), respectively, in the IRG. The quadriceps femoris EPT increased from 26.19 (SD 10.26) to 35.00 (SD 13.74) Nm (P=.004) in the TRG and from 26.95 (SD 11.81) to 32.74 (SD 12.33) Nm (P=.003) in the IRG. The BBS scores significantly improved in both groups (P<.001), with the mean TRG score increasing by 3.19 (SD 2.86) points and the mean IRG score by 3.06 (SD 2.44) points. Neither group exhibited significant within-group changes on the TUGT or the 6MWT. Both groups reported significant improvements in the IADL (TRG: P=.04; IRG: P=.02). Between-group comparisons revealed no significant differences in changes in all indicators. Conclusions: A 4-week remote resistance training program is effective in improving strength, balance, and the IADL in older adults with sarcopenia, with effects comparable to rehabilitation supervised by a physical therapist. Telerehabilitation may be a convenient and effective alternative for older adults with sarcopenia who have limited access to rehabilitation resources. Trial Registration: ChiCTR 2300071648; https://www.chictr.org.cn/showprojEN.html?proj=196313 %M 39854716 %R 10.2196/67846 %U https://www.jmir.org/2025/1/e67846 %U https://doi.org/10.2196/67846 %U http://www.ncbi.nlm.nih.gov/pubmed/39854716 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 12 %N %P e67785 %T Effectiveness of Digital Mental Health Interventions in the Workplace: Umbrella Review of Systematic Reviews %A Cameron,Gillian %A Mulvenna,Maurice %A Ennis,Edel %A O'Neill,Siobhan %A Bond,Raymond %A Cameron,David %A Bunting,Alex %+ School of Computing, Ulster University, 2-24 York Street, Belfast, BT15 1AP, United Kingdom, 44 7753 430736, cameron-g2@ulster.ac.uk %K digital interventions for mental health %K workplace wellbeing %K stress %K anxiety %K depression %K burnout %K CBT %K umbrella review %K digital mental health %K evaluation %K psychological %K databases %K Pubmed %K Web of Science %K Medline %K Cochrane Library %K PRISMA %D 2025 %7 24.1.2025 %9 Review %J JMIR Ment Health %G English %X Background: There is potential for digital mental health interventions to provide affordable, efficient, and scalable support to individuals. Digital interventions, including cognitive behavioral therapy, stress management, and mindfulness programs, have shown promise when applied in workplace settings. Objective: The aim of this study is to conduct an umbrella review of systematic reviews in order to critically evaluate, synthesize, and summarize evidence of various digital mental health interventions available within a workplace setting. Methods: A systematic search was conducted to identify systematic reviews relating to digital interventions for the workplace, using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis). The review protocol was registered in the Open Science Framework. The following databases were searched: PubMed, Web of Science, MEDLINE, PsycINFO, and Cochrane Library. Data were extracted using a predefined extraction table. To assess the methodological quality of a study, the AMSTAR-2 tool was used to critically appraise systematic reviews of health care interventions. Results: The literature search resulted in 11,875 records, which was reduced to 14 full-text systematic literature reviews with the use of Covidence to remove duplicates and screen titles and abstracts. The 14 included reviews were published between 2014 and 2023, comprising 9 systematic reviews and 5 systematic reviews and meta-analyses. AMSTAR-2 was used to complete a quality assessment of the reviews, and the results were critically low for 7 literature reviews and low for the other 7 literature reviews. The most common types of digital intervention studied were cognitive behavioral therapy, mindfulness/meditation, and stress management followed by other self-help interventions. Effectiveness of digital interventions was found for many mental health symptoms and conditions in employee populations, such as stress, anxiety, depression, burnout, and psychological well-being. Factors such as type of technology, guidance, recruitment, tailoring, and demographics were found to impact effectiveness. Conclusions: This umbrella review aimed to critically evaluate, synthesize, and summarize evidence of various digital mental health interventions available within a workplace setting. Despite the low quality of the reviews, best practice guidelines can be derived from factors that impact the effectiveness of digital interventions in the workplace. Trial Registration: OSF Registries osf.io/rc6ds; https://doi.org/10.17605/OSF.IO/RC6DS %M 39854722 %R 10.2196/67785 %U https://mental.jmir.org/2025/1/e67785 %U https://doi.org/10.2196/67785 %U http://www.ncbi.nlm.nih.gov/pubmed/39854722 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e63197 %T Digital Mindfulness Training for Burnout Reduction in Physicians: Clinician-Driven Approach %A Antico,Lia %A Brewer,Judson %+ Brown University, Department of Behavioral and Social Sciences, 121 S Main St, Providence, RI, 02903, United States, 1 401 328 0763, lia_antico@brown.edu %K burnout %K anxiety %K empathy fatigue %K physician %K mindfulness %K digital therapeutics %K app %K smartphone %K podcast %K compassion %K health care provider %K training %K physician burnout %K cynicism %K efficacy %K treatment %K meditation %K chronic %K workplace stress %K digital health %K mHealth %K mobile phone %D 2025 %7 24.1.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Physician burnout is widespread in health care systems, with harmful consequences on physicians, patients, and health care organizations. Mindfulness training (MT) has proven effective in reducing burnout; however, its time-consuming requirements often pose challenges for physicians who are already struggling with their busy schedules. Objective: This study aimed to design a short and pragmatic digital MT program with input from clinicians specifically to address burnout and to test its efficacy in physicians. Methods: Two separate nonrandomized pilot studies were conducted. In the first study, 27 physicians received the digital MT in a podcast format, while in the second study, 29 physicians and nurse practitioners accessed the same training through a free app-based platform. The main outcome measure was cynicism, one dimension of burnout. The secondary outcome measures were emotional exhaustion (the second dimension of burnout), anxiety, depression, intolerance of uncertainty, empathy (personal distress, perspective taking, and empathic concern subscales), self-compassion, and mindfulness (nonreactivity and nonjudgment subscales). In the second study, worry, sleep disturbances, and difficulties in emotion regulation were also measured. Changes in outcomes were assessed using self-report questionnaires administered before and after the treatment and 1 month later as follow-up. Results: Both studies showed that MT decreased cynicism (posttreatment: 33% reduction; P≤.04; r≥0.41 and follow-up: 33% reduction; P≤.04; r≥0.45), while improvements in emotional exhaustion were observed solely in the first study (25% reduction, P=.02, r=.50 at posttreatment; 25% reduction, P=.008, r=.62 at follow-up). There were also significant reductions in anxiety (P≤.01, r≥0.49 at posttreatment; P≤.01, r≥0.54 at follow-up), intolerance of uncertainty (P≤.03, r≥.57 at posttreatment; P<.001, r≥0.66 at follow-up), and personal distress (P=.03, r=0.43 at posttreatment; P=.03, r=0.46 at follow-up), while increases in self-compassion (P≤.02, r≥0.50 at posttreatment; P≤.006, r≥0.59 at follow-up) and mindfulness (nonreactivity: P≤.001, r≥0.69 at posttreatment; P≤.004, r≥0.58 at follow-up; nonjudgment: P≤.009, r≥0.50 at posttreatment; P≤.03, r≥0.60 at follow-up). In addition, the second study reported significant decreases in worry (P=.04, r=0.40 at posttreatment; P=.006, r=0.58 at follow-up), sleep disturbances (P=.04, r=0.42 at posttreatment; P=.01, r=0.53 at follow-up), and difficulties in emotion regulation (P=.005, r=0.54 at posttreatment; P<.001, r=0.70 at follow-up). However, no changes were observed over time for depression or perspective taking and empathic concern. Finally, both studies revealed significant positive correlations between burnout and anxiety (cynicism: r≥0.38; P≤.04; emotional exhaustion: r≥0.58; P≤.001). Conclusions: To our knowledge, this research is the first where clinicians were involved in designing an intervention targeting burnout. These findings suggest that this digital MT serves as a viable and effective tool for alleviating burnout and anxiety among physicians. Trial Registration: ClinicalTrials.gov NCT06145425; https://clinicaltrials.gov/study/NCT06145425 %M 39854701 %R 10.2196/63197 %U https://formative.jmir.org/2025/1/e63197 %U https://doi.org/10.2196/63197 %U http://www.ncbi.nlm.nih.gov/pubmed/39854701 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e55932 %T Exploring Web-Based Support for Suicidal Ideation in the Scottish Population: Usability Study %A McClelland,Heather %A O'Connor,Rory C %A Gibson,Laura %A MacIntyre,Donald J %+ School of Health and Wellbeing, University of Glasgow, 90 Byres Road, Clarice Pears Building, Glasgow, G12 8TB, United Kingdom, 44 141 330 3299, heather.mcclelland@glasgow.ac.uk %K suicide prevention %K Scotland %K suicidal thoughts %K digital intervention %K internet %K self-help %K crisis intervention %D 2025 %7 24.1.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Suicide is a global health concern. In the United Kingdom, Scotland has the highest suicide rate. Lived experience and suicide prevention stakeholders in Scotland have identified a key gap in suicide prevention activities: the lack of 24-hour peer-driven web-based support for people who are suicidal. Objective: This usability study aimed to evaluate the feasibility, acceptability, utility, and reach of a suicide prevention website (Surviving Suicidal Thoughts) specifically designed to support residents in Scotland who are experiencing suicidal thoughts themselves or suspect or know someone who is experiencing suicidal thoughts. Intended support was delivered through the provision of personal testimony videos of individuals with lived experience. Methods: A peer-driven website was developed specifically to support residents of Scotland experiencing suicidal thoughts. The website included resources (eg, videos from lived experience and written guidance about how to respond to someone who may be experiencing suicidal thoughts) to help reduce distress, normalize experiences, and challenge distressing thoughts. The website was promoted via leading web-based social media channels and Google Ads. Evaluation of the website was based on website engagement, marketing strategy, and direct web user feedback via a cross-sectional survey. Results: Data were collected for 41 weeks (June 2022 to February 2023) spanning the launch of the website and the conclusion of the second marketing campaign. On average, the website received 99.9 visitors per day. A total of 56% (n=14,439) of visitors were female, ages ranged from younger than 18 years to older than 70 years (commonly between 25 and 34 years) and originated from all regions of Scotland. According to Google Search terms of Scottish residents, of the individuals indicated to be experiencing suicidal thoughts but not looking for help, 5.3% (n=920) engaged with the website compared to 10.5% (n=2898) who were indicated to be looking for help for themselves. Based on participant responses to the evaluation survey (n=101), the website was associated with a significant reduction in suicidal thoughts (P=.03). Reasons for visiting the website varied. Marketing data implied that people were more likely to engage with advertisements, which they felt were more personal, and visitors to the website were more likely to engage with videos, which corresponded to their age. Conclusions: A peer-led website may help residents of Scotland who are experiencing suicidal thoughts. Web-based interventions may have considerable reach in Scotland both in terms of age and geographic area. Engagement with the website was similar to other self-help websites for suicidal ideation; however, more nuanced methods of analyzing website engagement for help-seeking behavior are recommended. Future work would benefit from exploring the effectiveness of this website based on a larger participant sample with website modifications guided by the principles of social learning theory. %M 39854713 %R 10.2196/55932 %U https://formative.jmir.org/2025/1/e55932 %U https://doi.org/10.2196/55932 %U http://www.ncbi.nlm.nih.gov/pubmed/39854713 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 13 %N %P e64410 %T Effectiveness of Mobile Health–Based Gamification Interventions for Improving Physical Activity in Individuals With Cardiovascular Diseases: Systematic Review and Meta-Analysis of Randomized Controlled Trials %A Yu,Tianzhuo %A Parry,Monica %A Yu,Tianyue %A Xu,Linqi %A Wu,Yuejin %A Zeng,Ting %A Leng,Xin %A Tong,Qian %A Li,Feng %+ School of Nursing, Jilin University, School of Nursing Office Building, 4th Fl., 965 Xinjiang St, Changchun, 130021, China, 86 0431 85619377, fli@jlu.edu.cn %K cardiovascular diseases %K digital health %K mobile health %K gamification %K exercise %K physical activity %K systematic review %K meta-analysis %D 2025 %7 24.1.2025 %9 Review %J JMIR Serious Games %G English %X Background: Gamification refers to using game design elements in nongame contexts. Promoting physical activity (PA) through gamification is a novel and promising avenue for improving lifestyles and mitigating the advancement of cardiovascular diseases (CVDs). However, evidence of its effectiveness remains mixed. Objective: This systematic review and meta-analysis aimed to evaluate the efficacy of gamification interventions in promoting PA during short-term and follow-up periods in individuals with CVDs and to explore the most effective game design elements. Methods: A comprehensive search of 7 electronic databases was conducted for randomized controlled trials published in English from January 1, 2010, to February 3, 2024. Eligible studies used mobile health–based gamification interventions to promote PA or reduce sedentary behavior in individuals with CVDs. In total, 2 independent reviewers screened the retrieved records, extracted data, and evaluated the risk of bias using the RoB 2 tool. Discrepancies were resolved by a third reviewer. Meta-analyses were performed using a random-effects model with the Sidik-Jonkman method adjusted by the Knapp-Hartung method. Sensitivity analysis and influence analysis examined the robustness of results, while prediction intervals indicated heterogeneity. A meta-regression using a multimodel inference approach explored the most important game design elements. Statistical analyses were conducted using R (version 4.3.2; R Foundation for Statistical Computing). Results: In total, 6 randomized controlled trials were included. Meta-analysis of 5 studies revealed a small effect of gamification interventions on short-term PA (after sensitivity analysis: Hedges g=0.32, 95% CI 0.19-0.45, 95% prediction interval [PI] 0.02-0.62). Meta-analysis of 3 studies found the maintenance effect (measured with follow-up averaging 2.5 months after the end of the intervention) was small (Hedges g=0.20, 95% CI 0.12-0.29, 95% PI –0.01 to 0.41). A meta-analysis of 3 studies found participants taking 696.96 more steps per day than the control group (95% CI 327.80 to 1066.12, 95% PI –121.39 to 1515.31). “Feedback” was the most important game design element, followed by “Avatar.” Conclusions: This meta-analysis demonstrates that gamification interventions effectively promote PA in individuals with CVD, with effects persisting beyond the intervention period, indicating they are not merely novel effects caused by the game nature of gamification. The 95% PI suggests that implementing gamification interventions in similar populations in the future will lead to actual effects in promoting PA in the vast majority of cases. However, the limited number of included studies underscores the urgent need for more high-quality research in this emerging field. Trial Registration: PROSPERO CRD42024518795; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=518795 %M 39854099 %R 10.2196/64410 %U https://games.jmir.org/2025/1/e64410 %U https://doi.org/10.2196/64410 %U http://www.ncbi.nlm.nih.gov/pubmed/39854099 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e66353 %T Patient Experiences and Perspectives When MyChart is Introduced in a Large Community Hospital: Mixed Methods Study %A Vanderhout,Shelley %A Taneja,Shipra %A Kalia,Kamini %A Wodchis,Walter P %A Tang,Terence %+ Institute for Better Health, Trillium Health Partners, 2085 Hurontario Street, Mississauga, ON, L5A 4G1, Canada, 1 6473307192, shelley.vanderhout@thp.ca %K patient portal %K implementation %K mixed methods %K patient experiences %K patient perspectives %K learning health systems %K LHS %K mixed methods study %K electronic medical records %K health information %K caregiver experience %K Canada %K user satisfaction %K descriptive statistics %K thematic analysis %D 2025 %7 23.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Patient portals, or secure websites linked to electronic medical records, have emerged as tools to provide patients with timely access to their health information. To support the potential benefits of patient portals such as improved engagement in health care, it is essential to understand how patients and caregivers experience these portals. Objective: This study aimed to explore patient and caregiver experiences, facilitators, and barriers to accessing and using a patient portal called MyChart during the initial stages of its implementation. Methods: We applied explanatory sequential mixed methods to conduct a web-based questionnaire and semistructured interviews with MyChart users and nonusers at a large community hospital in Ontario, Canada. Among users, we explored user satisfaction with MyChart, its impact on care, and areas for improvement. For nonusers, we explored barriers to MyChart access and willingness to use it in the future. Descriptive statistics and thematic analysis were used for data analysis. Results: A total of 5651 patients and caregivers completed the web-based questionnaire and 18 (12 users and 6 nonusers) participated in interviews. MyChart users primarily learned about the portal through email (n=1288, 39%), after-visit summaries (n=953, 29%), and hospital staff (n=408, 12%). Nonusers cited lack of awareness (n=1291, 59%) and registration difficulties (n=707, 32%) as some barriers to activation and adoption, but the majority would consider activating and using MyChart if they could learn more about it (n=1126, 54%). Users valued MyChart for preparing for health care encounters but expressed dissatisfaction with limited features and access to medical history and test results, whereas nonusers tended to be unsure about the benefits of using MyChart, especially if they were infrequent health care users. Conclusions: Patient portals offer benefits, but barriers to access and limited functionality can hinder widespread use. To enhance the adoption and potential benefits of patient portals, targeted outreach and comprehensive access to health information are essential to promote positive and seamlessly integrated health care experiences. %M 39847431 %R 10.2196/66353 %U https://www.jmir.org/2025/1/e66353 %U https://doi.org/10.2196/66353 %U http://www.ncbi.nlm.nih.gov/pubmed/39847431 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e64981 %T Digital Health Solutions for Cardiovascular Disease Prevention: Systematic Review %A Qi,Yihan %A Mohamad,Emma %A Azlan,Arina Anis %A Zhang,Chenglin %A Ma,Yilian %A Wu,Anqi %+ Centre for Research in Media and Communication, Faculty of Social Sciences and Humanities, Universiti Kebangsaan Malaysia, UKM, Selangor, 43600, Malaysia, 60 389215457, emmamohamad@ukm.edu.my %K cardiovascular disease prevention %K cardiovascular outcomes %K digital technologies %K remote care %K mobile phone %D 2025 %7 23.1.2025 %9 Review %J J Med Internet Res %G English %X Background: Cardiovascular disease (CVD) is a major global health issue, with approximately 70% of cases linked to modifiable risk factors. Digital health solutions offer potential for CVD prevention; yet, their effectiveness in covering the full range of prevention strategies is uncertain. Objective: This study aimed to synthesize current literature on digital solutions for CVD prevention, identify the key components of effective digital interventions, and highlight critical research gaps to inform the development of sustainable strategies for CVD prevention. Methods: Following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we conducted a comprehensive search in Web of Science, Scopus, and PubMed to identify original English-language studies published between January 2000 and May 2024 that examined primary or secondary CVD prevention through digital solutions. The exclusion criteria included: telephone-only interventions, abstract-only publications, methodology-focused studies without primary data, studies without participants or specific groups, and studies with no follow-up period. The literature search used the string with terms like “digital health,” “mHealth,” “mobile health,” “text message,” “short message service,” “SMS,” “prevention,” “prevent,” “cardiovascular disease,” “CVD,” etc. Study bias was assessed using the RoB 2 (Cochrane Collaboration) and the ROBINS-I tool (Cochrane Collaboration). Data on prevention components, prevention types, study design, population, intervention, follow-up duration, personnel, and delivery settings were extracted. Results: A total of 2871 studies were identified through the search. After excluding ineligible studies, 30 studies remained, including 24 randomized controlled trials. The reviewed digital solutions for CVD prevention focused on baseline assessment (29/30, 97%), physical activity counseling (18/30, 60%), tobacco cessation (14/30, 47%), blood pressure management (13/30, 43%), and medication adherence (10/30, 33%). The technologies used were categorized into 3 types, smartphones and wearables (16/30, 53%), email and SMS communications (12/30, 40%), and websites or web portals (3/30, 10%). The majority of the study outcomes addressed blood pressure (14/30, 47%), exercise capacity (12/30, 40%), weight (12/30, 40%), and lipid profile (11/30, 37%), while fewer focused on nicotine dependence (9/30, 30%), medication use (8/30, 27%), quality of life (7/30, 23%), dietary habits (5/30, 17%), intervention adherence (4/30, 13%), waist circumference (4/30, 13%), and blood glucose levels (2/30, 7%). Conclusions: Digital solutions can address challenges in traditional CVD prevention by improving preventive behaviors and monitoring health indicators. However, most evaluated interventions have focused on medication use, quality of life, dietary habits, adherence, and waist circumference. Further studies are needed to assess the long-term impact of more comprehensive interventions on key cardiovascular outcomes. %M 39847411 %R 10.2196/64981 %U https://www.jmir.org/2025/1/e64981 %U https://doi.org/10.2196/64981 %U http://www.ncbi.nlm.nih.gov/pubmed/39847411 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e64483 %T Identifying the Minimal Clinically Important Difference in Emotion Regulation Among Youth Using the JoyPop App: Survey Study %A Charlton,Jaidyn %A Malik,Ishaq %A Ashley,Angela M %A Newton,Amanda %A Toombs,Elaine %A Schmidt,Fred %A Olthuis,Janine V %A Stasiuk,Kristine %A Bobinski,Tina %A Mushquash,Aislin %+ Department of Psychology, Lakehead University, 955 Oliver Road, Thunder Bay, ON, Canada, 1 8073438010 ext 8771, aislin.mushquash@lakeheadu.ca %K mHealth %K mobile health %K app %K psychometrics %K emotion regulation %K Indigenous mental health %K Indigenous youth %K mental health interventions %K resilience %K clinical psychology %K adolescent mental health %K mental health %K JoyPop %K pediatrics %K mobile phone %D 2025 %7 23.1.2025 %9 Short Paper %J JMIR Form Res %G English %X Background: The minimal clinically important difference (MCID) is an important threshold to consider when evaluating the meaningfulness of improvement following an intervention. The JoyPop app is an evidence-based smartphone app designed to improve resilience and emotion regulation. Information is needed regarding the JoyPop app’s MCID among culturally diverse youth. Objective: This study aims to calculate the MCID for youth using the JoyPop app and to explore how the MCID may differ for a subset of Indigenous youth. Methods: Youth (N=36; aged 12-18 years) were recruited to use the JoyPop app for up to 4 weeks as part of a larger pilot evaluation. Results were based on measures completed after 2 weeks of app use. The MCID was calculated using emotion regulation change scores (Difficulties in Emotion Regulation–Short Form [DERS-SF]) and subjective ratings on the Global Rating of Change Scale (GRCS). This MCID calculation was completed for youth overall and separately for Indigenous youth only. Results: A significant correlation between GRCS scores and change scores on the DERS-SF supported face validity (r=–0.37; P=.04). The MCID in emotion regulation following the use of the JoyPop app for youth overall was 2.80 on the DERS-SF. The MCID for Indigenous youth was 4.29 on the DERS-SF. In addition, most youth reported improved emotion regulation after using the JoyPop app. Conclusions: These MCID findings provide a meaningful threshold for improvement in emotion regulation for the JoyPop app. They provide potential effect sizes and can aid in sample size estimations for future research with the JoyPop app or e-mental health technologies in general. The difference between overall youth and Indigenous youth MCID values also highlights the importance of patient-oriented ratings of symptom improvement as well as cultural considerations when conducting intervention research and monitoring new interventions in clinical practice. %M 39847426 %R 10.2196/64483 %U https://formative.jmir.org/2025/1/e64483 %U https://doi.org/10.2196/64483 %U http://www.ncbi.nlm.nih.gov/pubmed/39847426 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e60868 %T Use of Go-Beyond as a Self-Directed Internet-Based Program Supporting Veterans’ Transition to Civilian Life: Preliminary Usability Study %A Alichniewicz,Karolina Katarzyna %A Hampton,Sarah %A Romaniuk,Madeline %A Bennett,Darcy %A Guindalini,Camila %+ Greenslopes Private Hospital, Gallipoli Medical Research, Newdegate Street, Greenslopes, Brisbane, QLD 4120, Australia, 61 7 33947613, alichniewiczkarolina@gallipoliresearch.org.au %K military transition %K web-based interventions %K military-civilian adjustment %K Go-Beyond %K internet-based program %K civilian %K military service %K veteran %K premilitary life %K mental health issues %K physical injuries %K adoption %K quantitative analysis %K survey %K family %K support %K digital technology %K user engagement %K effectiveness %K assessment %D 2025 %7 23.1.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: The transition from military service to civilian life presents a variety of challenges for veterans, influenced by individual factors such as premilitary life, length of service, and deployment history. Mental health issues, physical injuries, difficulties in relationships, and identity loss compound the reintegration process. To address these challenges, various face-to-face and internet-based programs are available yet underused. This paper presents the preliminary evaluation of “Go-Beyond, Navigating Life Beyond Service,” an internet-based psychoeducational program for veterans. Objective: The study aims to identify the reach, adoption, and engagement with the program and to generate future recommendations to enhance its overall impact. Methods: This study exclusively used data that were automatically and routinely collected from the start of the Go-Beyond program’s launch on May 24, 2021, until May 7, 2023. When accessing the Go-Beyond website, veterans were asked to complete the Military-Civilian Adjustment and Reintegration Measure (M-CARM) questionnaire, which produces a unique M-CARM profile of results specifying potential areas of need on the 5 domains of the measure. Users were then automatically allocated to Go-Beyond modules that aligned with their M-CARM profile. Additionally, quantitative and qualitative data were collected from a survey on aesthetics, interactivity, user journey, and user experience, which was optional for users to complete at the end of each module. Results: Results show a conversion rate of 28.5% (273/959) from the M-CARM survey to the Go-Beyond program. This rate is notably higher compared with similar internet-based self-help programs, such as VetChange (1033/22,087, 4.7%) and resources for gambling behavior (5652/8083, 14%), but lower than the MoodGYM program (82,159/194,840, 42.2%). However, these comparisons should be interpreted with caution due to the limited availability of published conversion rates and varying definitions of uptake and adoption across studies. Additionally, individuals were 1.64 (95% CI 1.17-2.28) more likely to enroll when they express a need in Purpose and Connection, and they were 1.50 (95% CI 1.06-2.18) times more likely to enroll when they express the need Beliefs About Civilians, compared with those without these needs. The overall completion rate for the program was 31% (85/273) and modules’ individual completion rates varied from 8.4% (17/203) to 20% (41/206). Feedback survey revealed high overall user satisfaction with Go-Beyond, emphasizing its engaging content and user-friendly modules. Notably, 94% (88/94) of survey respondents indicated they would recommend the program to other veterans, family, or friends. Conclusions: The Go-Beyond program may offer promising support for veterans transitioning to civilian life through digital technology. Our study reveals insights on user engagement and adoption, emphasizing the need for ongoing evaluation to further address the diverse needs of military personnel. Future research should explore predictors of engagement, the addition of peer or facilitator support, and the use of outcome measures for effectiveness assessment. %M 39847427 %R 10.2196/60868 %U https://formative.jmir.org/2025/1/e60868 %U https://doi.org/10.2196/60868 %U http://www.ncbi.nlm.nih.gov/pubmed/39847427 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e58177 %T A Novel Artificial Intelligence–Enhanced Digital Network for Prehospital Emergency Support: Community Intervention Study %A Kim,Ji Hoon %A Kim,Min Joung %A Kim,Hyeon Chang %A Kim,Ha Yan %A Sung,Ji Min %A Chang,Hyuk-Jae %+ Department of Cardiology, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea, 82 2 2228 2460, hjchang@yuhs.ac %K emergency patient transport %K transport time %K artificial intelligence %K smartphone %K mobile phone %D 2025 %7 23.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Efficient emergency patient transport systems, which are crucial for delivering timely medical care to individuals in critical situations, face certain challenges. To address this, CONNECT-AI (CONnected Network for EMS Comprehensive Technical-Support using Artificial Intelligence), a novel digital platform, was introduced. This artificial intelligence (AI)–based network provides comprehensive technical support for the real-time sharing of medical information at the prehospital stage. Objective: This study aimed to evaluate the effectiveness of this system in reducing patient transport delays. Methods: The CONNECT-AI system provided 3 key AI services to prehospital care providers by collecting real-time patient data from the scene and hospital resource information, such as bed occupancy and the availability of emergency surgeries or procedures, using 5G communication technology and internet of things devices. These services included guidance on first aid, prediction of critically ill patients, and recommendation of the optimal transfer hospital. In addition, the platform offered emergency department medical staff real-time clinical information, including live video of patients during transport to the hospital. This community-based, nonrandomized controlled intervention study was designed to evaluate the effectiveness of the CONNECT-AI system in 2 regions of South Korea, each of which operated an intervention and a control period, each lasting 16 weeks. The impact of the system was assessed based on the proportion of patients experiencing transfer delays. Results: A total of 14,853 patients transported by public ambulance were finally selected for analysis. Overall, the median transport time was 10 (IQR 7-14) minutes in the intervention group and 9 (IQR 6-13) minutes in the control group. When comparing the incidence of transport time outliers (>75%), which was the primary outcome of this study, the rate was higher in the intervention group in region 1, but significantly reduced in region 2, with the overall outlier rate being higher in the intervention group (27.5%-29.7%, P=.04). However, for patients with fever or respiratory symptoms, the group using the system showed a statistically significant reduction in outlier cases (36.5%-30.1%, P=.01). For patients who received real-time acceptance signals from the hospital, the reduction in the percentage of 75% outliers was statistically significant compared with those without the system (27.5%-19.6%, P=.02). As a result of emergency department treatment, 1.5% of patients in the control group and 1.1% in the intervention group died (P=.14). In the system-guided optimal hospital transfer group, the mortality rate was significantly lower than in the control group (1.54%-0.64%, P=.01). Conclusions: The present digital emergency medical system platform offers a novel approach to enhancing emergency patient transport by leveraging AI, real-time information sharing, and decision support. While the system demonstrated improvements for certain patient groups facing transfer challenges, further research and modifications are necessary to fully realize its benefits in diverse health care contexts. Trial Registration: ClinicalTrials.gov NCT04829279; https://clinicaltrials.gov/study/NCT04829279 %M 39847421 %R 10.2196/58177 %U https://www.jmir.org/2025/1/e58177 %U https://doi.org/10.2196/58177 %U http://www.ncbi.nlm.nih.gov/pubmed/39847421 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e58985 %T Adaptive Just-in-Time Intervention to Reduce Everyday Stress Responses: Protocol for a Randomized Controlled Trial %A Johnson,Jillian A %A Zawadzki,Matthew J %A Sliwinski,Martin J %A Almeida,David M %A Buxton,Orfeu M %A Conroy,David E %A Marcusson-Clavertz,David %A Kim,Jinhyuk %A Stawski,Robert S %A Scott,Stacey B %A Sciamanna,Christopher N %A Green,Paige A %A Repka,Emily M %A Toledo,Meynard John L %A Sturges,Nicole L %A Smyth,Joshua M %+ Department of Psychology, The Ohio State University, 133 Psychology Building, Columbus, OH, 43210, United States, 1 8148638402, smyth.88@osu.edu %K stress %K stress responses %K stress management %K just-in-time adaptive intervention %K sleep %K physical activity %K behavior change %K experimental medicine approach %D 2025 %7 22.1.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Personalized approaches to behavior change to improve mental and physical health outcomes are needed. Reducing the intensity, duration, and frequency of stress responses is a mechanism for interventions to improve health behaviors. We developed an ambulatory, dynamic stress measurement approach that can identify personalized stress responses in the moments and contexts in which they occur; we propose that intervening in these stress responses as they arise (ie, just in time; JIT) will result in positive impacts on health behaviors. Objective: This study aims to (1) use an experimental medicine approach to evaluate the impact of a smartphone-delivered JIT stress management intervention on the frequency and intensity of person-specific stress responses (ie, stress reactivity, nonrecovery, and pileup); (2) evaluate the impact of the JIT intervention on the enactment of health behaviors in everyday life (physical activity and sleep); and (3) explore whether changes in stress responses mediate the interventions’ effects on health behaviors. Methods: In a 2-arm phase 2 clinical trial, we will enroll 210 adults in either a JIT stress management intervention or an active control condition. For 4 weeks, participants will complete 8 brief smartphone surveys each day and wear devices to assess sleep and physical activity. After a 1-week run-in period, participants will be randomized into the JIT intervention or an active control condition for 2 weeks. Participants in the JIT intervention will receive very brief stress management activities when reporting greater than typical stress responses, whereas control participants will receive no personalized stress management activities. Participants enrolled in both conditions will engage in self-monitoring for the entire study period and have access to a general stress management education module. Self-report outcomes will be assessed again 1 month after the intervention. We will use mixed-effects models to evaluate differences in person-specific stress responses between the intervention and control groups. We will conduct parallel analyses to evaluate whether the intervention is associated with improvement in health behavior enactment (ie, sleep and physical activity). The Pennsylvania State University Institutional Review Board approved all study procedures (STUDY00012740). Results: Initial participant recruitment for the trial was initiated on August 15, 2022, and enrollment was completed on June 9, 2023. A total of 213 participants were enrolled in this period. Data are currently being processed; analyses have not yet begun. Conclusions: We anticipate that this research will contribute to advancing stress measurement, thereby enhancing understanding of health behavior change mechanisms and, more broadly, providing a conceptual roadmap to advance JIT interventions aimed at improving stress management and health behaviors. Trial Registration: Clinicaltrials.gov NCT05502575; https://clinicaltrials.gov/study/NCT05502575 International Registered Report Identifier (IRRID): DERR1-10.2196/58985 %M 39842791 %R 10.2196/58985 %U https://www.researchprotocols.org/2025/1/e58985 %U https://doi.org/10.2196/58985 %U http://www.ncbi.nlm.nih.gov/pubmed/39842791 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e54148 %T Effectiveness of a Web-Based Medication Education Course on Pregnant Women’s Medication Information Literacy and Decision Self-Efficacy: Randomized Controlled Trial %A Li,Suya %A Chen,Hui-Jun %A Zhou,Jie %A Zhouchen,Yi-Bei %A Wang,Rong %A Guo,Jinyi %A Redding,Sharon R %A Ouyang,Yan-Qiong %+ Wuhan University, 115 Donghu Road, Wuchang District, Wuhan, 430071, China, 86 02768758747, ouyangyq@whu.edu.cn %K decision self-efficacy %K self-efficacy %K decision efficacy %K medication information literacy %K information literacy %K web-based medication education %K medication education %K web-based platforms %K pregnant women %K pregnancy %K RCT %K randomized controlled trial %D 2025 %7 22.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Medication-related adverse events are common in pregnant women, and most are due to misunderstanding medication information. The identification of appropriate medication information sources requires adequate medical information literacy (MIL). It is important for pregnant women to comprehensively evaluate the risk of medication treatment, self-monitor their medication response, and actively participate in decision-making to reduce medication-related adverse events. Objective: This study aims to examine the effectiveness of a medication education course on a web-based platform in improving pregnant women’s MIL and decision self-efficacy. Methods: A randomized controlled trial was conducted. Pregnant women were recruited from January to June 2021 in the Department of Obstetrics and Gynecology of a large hospital in a major city in central China. A total of 108 participants were randomly divided into a control group (CG), which received routine prenatal care from nurses and physicians, and an intervention group (IG), which received an additional 3-week web-based medication education course based on the theory of planned behavior as part of routine prenatal care. Participants completed a Medication Information Literacy Scale and a decision self-efficacy questionnaire at baseline, upon completion of the intervention, and at a 4-week follow-up. Generalized estimation equations (GEE) were used to analyze the main effect (time and grouping) and interaction effect (grouping×time) of the 2 outcomes. The CONSORT-EHEALTH (V 1.6.1) checklist was used to guide the reporting of this randomized controlled trial. Results: A total of 91 pregnant women (48 in the IG and 43 in the CG) completed the questionnaires at the 3 time points. The results of GEE indicated that there was no statistically significant difference in time×group interactions of MIL between the 2 groups (F2=3.12; P=.21). The results of the main effect analysis showed that there were statistically significant differences in MIL between the 2 groups at T1 and T2 (F1=17.79; P<.001). Moreover, the results of GEE indicated that there was a significant difference in decision self-efficacy regarding the time factor, grouping factor, and time×group interactions (F2=21.98; P<.001). The results of the simple effect analysis indicated a statistically significant difference in decision self-efficacy between the 2 groups at T1 (F1=36.29; P<.001) and T2 (F1=36.27; P<.001) compared to T0. Results showed that MIL and decision self-efficacy in the IG were found to be significantly higher than those in the CG (d=0.81; P<.001 and d=1.26; P<.001, respectively), and they remained significantly improved at the 4-week follow-up (d=0.59; P<.001 and d=1.27; P<.001, respectively). Conclusions: Web-based medication education courses based on the theory of planned behavior can effectively improve pregnant women’s MIL and decision self-efficacy, and they can be used as supplementary education during routine prenatal care. Trial Registration: Chinese Clinical Trial Registry ChiCTR2100041817; https://www.chictr.org.cn/showproj.html?proj=66685 %M 39841986 %R 10.2196/54148 %U https://www.jmir.org/2025/1/e54148 %U https://doi.org/10.2196/54148 %U http://www.ncbi.nlm.nih.gov/pubmed/39841986 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 12 %N %P e57405 %T Integrating Videoconferencing Therapist Guidance Into Stepped Care Internet-Delivered Cognitive Behavioral Therapy for Child and Adolescent Anxiety: Noninferiority Randomized Controlled Trial %A March,Sonja %A Spence,Susan H %A Myers,Larry %A Ford,Martelle %A Smith,Genevieve %A Donovan,Caroline L %+ Centre for Health Research & School of Psychology and Wellbeing, University of Southern Queensland Education City, 37 Sinnathamby Blvd, Springfield Central, 4300, Australia, 61 7 3470 4434, sonja.march@unisq.edu.au %K internet-delivered cognitive behavioral therapy %K ICBT %K anxiety %K child %K adolescent %K stepped care %K videoconferencing %D 2025 %7 22.1.2025 %9 Original Paper %J JMIR Ment Health %G English %X Background: Self-guided internet-delivered cognitive behavioral therapy (ICBT) achieves greater reach than ICBT delivered with therapist guidance, but demonstrates poorer engagement and fewer clinical benefits. Alternative models of care are required that promote engagement and are effective, accessible, and scalable. Objective: This randomized trial evaluated whether a stepped care approach to ICBT using therapist guidance via videoconferencing for the step-up component (ICBT-SC[VC]) is noninferior to ICBT with full therapist delivery by videoconferencing (ICBT-TG[VC]) for child and adolescent anxiety. Methods: Participants included 137 Australian children and adolescents aged 7 to 17 years (male: n=61, 44.5%) with a primary anxiety disorder who were recruited from participants presenting to the BRAVE Online website. This noninferiority randomized trial compared ICBT-SC[VC] to an ICBT-TG[VC] program, with assessments conducted at baseline, 12 weeks, and 9 months after treatment commencement. All ICBT-TG[VC] participants received therapist guidance (videoconferencing) after each session for all 10 sessions. All ICBT-SC[VC] participants completed the first 5 sessions online without therapist guidance. If they demonstrated response to treatment after 5 sessions (defined as reductions in anxiety symptoms to the nonclinical range), they continued sessions without therapist guidance. If they did not respond, participants were stepped up to receive supplemental therapist guidance (videoconferencing) for the remaining sessions. The measures included a clinical diagnostic interview (Anxiety Disorders Interview Schedule) with clinician-rated severity rating as the primary outcome and parent- and child-reported web-based surveys assessing anxiety and anxiety-related interference (secondary outcomes). Results: Although there were no substantial differences between the treatment conditions on primary and most secondary outcome measures, the noninferiority of ICBT-SC[VC] compared to ICBT-TG[VC] could not be determined. Significant clinical benefits were evident for participants in both treatments, although this was significantly higher for the ICBT-TG[VC] participants. Of the 89 participants (38 in ICBT-SC[VC] and 51 in ICBT-TG[VC]) who remained in the study, 26 (68%) in ICBT-SC[VC] and 45 (88%) in ICBT-TG[VC] were free of their primary anxiety diagnosis by the 9-month follow-up. For the intention-to-treat sample (N=137), 41% (27/66) ICBT-SC[VC], and 69% (49/71) ICBT-TG[VC] participants were free of their primary anxiety diagnosis. Therapy compliance was lower for the ICBT-SC[VC] participants (mean 7.39, SD 3.44 sessions) than for the ICBT-TG[VC] participants (mean 8.73, SD 3.08 sessions), although treatment satisfaction was moderate to high in both conditions. Conclusions: This study provided further support for the benefits of low-intensity ICBT for children and adolescents with a primary anxiety disorder and highlighted the excellent treatment outcomes that can be achieved through therapist-guided ICBT delivered via videoconferencing. Although noninferiority of the stepped care adaptive approach could not be determined, it was acceptable to families, produced good outcomes, and could assist in increasing access to evidence-based care. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618001418268; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001418268 %M 39841993 %R 10.2196/57405 %U https://mental.jmir.org/2025/1/e57405 %U https://doi.org/10.2196/57405 %U http://www.ncbi.nlm.nih.gov/pubmed/39841993 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e58319 %T Efficacy of a Mobile Health–Based Behavioral Treatment for Lifestyle Modification in Type 2 Diabetes Self-Management: Greenhabit Randomized Controlled Trial %A Ruiz-Leon,Ana Maria %A Casas,Rosa %A Castro-Barquero,Sara %A Alfaro-González,Sofia %A Radeva,Petia %A Sacanella,Emilio %A Casanovas-Garriga,Francesc %A Pérez-Gesalí,Ainhoa %A Estruch,Ramon %+ Department of Internal Medicine, Hospital Clinic, Institut d’Investigacio Biomèdica August Pi i Sunyer, Villarroel, 170, Barcelona, 08036, Spain, 34 932275745, rcasas1@recerca.clinic.cat %K type 2 diabetes %K cardiovascular health %K lifestyle intervention %K mHealth %K artificial intelligence %K mobile health %K mobile application %K diabetes %K DM %K self-management %K randomized controlled trial %K RCT %K health care %K self-care %K Greenhabit %K behavioral health %K treatment %K medication %K analysis of covariance %K intervention %K work-life balance %K cardiovascular %K cardiovascular risk %D 2025 %7 22.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Enhancing self-management in health care through digital tools is a promising strategy to empower patients with type 2 diabetes (T2D) to improve self-care. Objective: This study evaluates whether the Greenhabit (mobile health [mHealth]) behavioral treatment enhances T2D outcomes compared with standard care. Methods: A 12-week, parallel, single-blind randomized controlled trial was conducted with 123 participants (62/123, 50%, female; mean age 58.25 years, SD 9.46 years) recently diagnosed with T2D. Participants were recruited face-to-face from primary care centers in Barcelona, Spain, between July 2021 and March 2022. They were randomly assigned to 1 of 2 groups: (1) an intervention group (n=61) instructed to use the Greenhabit mobile app alongside standard care, or (2) a control group (n=62) who received advice on maintaining a healthy diet and followed standard care. The Greenhabit app incorporates serious gaming technology. Participants received daily messages and challenges focused on promoting a healthy lifestyle, including nutrition, exercise, relaxation, a positive mindset, and a supportive social environment. The app encouraged participants to set weekly goals and awarded points for completing challenges. Data on nutrition, anthropometrics, and blood and urine samples were collected at baseline, 6 weeks, and 12 weeks. Questionnaires assessing quality of life, work-life balance, and social environment were administered at baseline and during the final visit. The primary outcomes were HbA1c and fasting plasma glucose (FPG). Repeated-measures analysis of variance was used to compare changes over time (baseline to 6 weeks and baseline to 12 weeks) between the 2 intervention groups. Analysis of covariance was performed to evaluate changes at 6 and 12 weeks, adjusted for baseline levels of each variable. Multiple contrasts were corrected using a Bonferroni post hoc test. Results: Both groups showed significant reductions in HbA1c after 6 and 12 weeks (mean change in the intervention group [n=50] –0.4%, P<.001 vs –0.3% in the control group [n=53], P=.001) and in FPG after 6 weeks (mean change in the intervention group –5.3 mg/dL, P=.01 vs control group –5.8 mg/dL, P=.01). At 12 weeks, the intervention group also showed significant reductions in systolic and diastolic blood pressures (mean change –4.5, P=.049 and –2.4 mmHg, P=.03, respectively), body weight (mean change –0.8 kg, P=.03), BMI (mean change –0.3 kg/m2, P=.03), waist circumference (mean change –1.0 cm, P=.046), and triglyceride concentration (mean change –20.0 mg/dL, P=.03). There was also a significant increase in high-density lipoprotein-cholesterol concentrations (mean change 2 mg/dL, P=.049). Finally, improvements were noted in 3 out of the 5 elements of balance: positivity, social environment, and work-life balance. Conclusions: The 12-week intervention with the Greenhabit behavioral treatment mHealth app showed beneficial effects on T2D outcomes and reduced the burden of cardiovascular risk factors. Although larger studies are warranted, these results suggest that mHealth apps can be a promising tool for improving T2D self-management. Trial Registration: ISRCTN Registry ISRCTN13456652; http://www.isrctn.com/ISRCTN13456652 %M 39841995 %R 10.2196/58319 %U https://www.jmir.org/2025/1/e58319 %U https://doi.org/10.2196/58319 %U http://www.ncbi.nlm.nih.gov/pubmed/39841995 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e52159 %T Improving Outcomes and Quality of Life for Patients With Hand and Foot Eczema: Randomized Study of a Patient-Centered Monitoring App %A Bruch,Aimee %A Weigandt,Wanja %A Schardt,Yannic %A Herr,Raphael %A Benecke,Johannes %A Schmieder,Astrid %+ Department of Dermatology, Venereology and Allergology, University Hospital Würzburg, Josef-Schneider-Strasse 2, Würzburg, 97080, Germany, 49 +4993120126234, schmieder_a@ukw.de %K hand and foot eczema %K eHealth %K mHealth %K teledermatology %K telemedicine %K disease management %K smartphone application %K mental health %K eczema %K clinical outcome %K quality of life %K dermatology %K pain %K motor skills %K educational %K support %K mobile phone %D 2025 %7 21.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Hand and foot eczema is a frequent chronic dermatological condition. The persistent itching, pain, and blistering can impair hand and foot function, leading to difficulties in performing tasks requiring fine motor skills. In addition, the impact on the quality of life for affected patients is significant, as the symptoms can be extremely uncomfortable and disruptive to daily activities. By incorporating digital health apps and educational programs into the management of hand and foot eczema, patients may receive ongoing support, optimize their clinical outcomes, and ultimately enhance their overall quality of life. Objective: The purpose of this study was to evaluate the effect of a smartphone app combined with educational training on the clinical outcomes and mental health of patients with chronic hand and foot eczema during a 60-week study period. Methods: Patients in the intervention group participated in an educational program focused on chronic hand and foot eczema at baseline and had in-person visits at weeks 0, 12, 24, 36, and 60, as well as access to our study smartphone app. The app allowed patients to upload pictures of their hands and feet and answer questions about pain severity, itching, mood, and quality of life. A chat function was also available for patients to contact their dermatologist. The control group received only the in-person study visits described above. Results: A total of 87 patients were included in the study and randomized to the intervention (n=43) or control (n=44) groups. In total, 23 patients from the intervention group and 34 patients from the control group completed the study. Throughout the 60-week study period, a significant reduction in Hand Eczema Severity Index (HECSI) was consistently observed in all patients (week 60: linear regression coefficient [Coef]=–1.108; P≤.001). A trend toward a greater improvement of the HECSI in the intervention group compared to the control group was noticed (week 60: Coef=0.597; P=.05). Subgroup analysis revealed that patients who used the app with a usage frequency of less than 20% demonstrated a significant reduction in the HECSI from week 0 to week 60 (week 60: Coef=–1.275; P=.04) and a significant reduction in the Dermatology Life Quality Index (week 60: Coef=–1.246; P=.04) compared to the control group. We were able to demonstrate a significant correlation between the HECSI calculated based on pictures uploaded by patients through the app and the HECSI assessed during personal visits (ρ=0.885; P<.001), despite the potentially lower image quality of the pictures uploaded through the app. Conclusions: This study provides further evidence that digital health apps can provide valuable support in improving patient clinical outcomes and management, especially as the app-based assessment of hand and feed images appears to be reliable. Trial Registration: Deutsches Register Klinischer Studien DRKS00020963; https://drks.de/search/de/trial/DRKS00020963 %M 39836950 %R 10.2196/52159 %U https://www.jmir.org/2025/1/e52159 %U https://doi.org/10.2196/52159 %U http://www.ncbi.nlm.nih.gov/pubmed/39836950 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e63567 %T Development of an eHealth Intervention Including Self-Management for Reducing Sedentary Time in the Transition to Retirement: Participatory Design Study %A Hultman,Lisa %A Eklund,Caroline %A von Heideken Wågert,Petra %A Söderlund,Anne %A Lindén,Maria %A Elfström,Magnus L %+ Division of Physiotherapy, School of Health, Care and Social Welfare, Mälardalen University, Box 883, Västerås/Eskilstuna, 721 23, Sweden, 46 21 48 06 901, lisa.hultman@mdu.se %K behavior change intervention %K adherence %K integrated behavior change model %K autonomous motivation %K affective determinants %D 2025 %7 20.1.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Having a great amount of sedentary time is common among older adults and increases with age. There is a strong need for tools to reduce sedentary time and promote adherence to reduced sedentary time, for which eHealth interventions have the potential to be useful. Interventions for reducing sedentary time in older adults have been found to be more effective when elements of self-management are included. When creating new eHealth interventions, accessibility and effectiveness can be increased by including end users as co-designers in the development process. Objective: The aim was to explore the desired features of an eHealth intervention including self-management for reducing sedentary time and promoting adherence to reduced sedentary time in older adults transitioning from working life to retirement. Further, the aim was to develop a digital prototype of such an eHealth intervention. Methods: The study used the participatory design approach to include end users, researchers, and a web designer as equal partners. Three workshops were conducted with 6 older adults transitioning to retirement, 2 researchers, and 1 web designer. Thematic analysis was used to analyze the data from the workshops. Results: Participants expressed a desire for an easy-to-use eHealth intervention, which could be accessed from mobile phones, tablets, and computers, and could be individualized to the user. The most important features for reducing sedentary time were those involving finding joyful activities, setting goals, and getting information regarding reduced sedentary time. Participants expressed that the eHealth intervention would need to first provide the user with knowledge regarding sedentary time, then offer features for measuring sedentary time and for setting goals, and lastly provide support in finding joyful activities to perform in order to avoid being sedentary. According to the participants, an eHealth intervention including self-management for reducing sedentary time in older adults in the transition to retirement should be concise, accessible, and enjoyable. A digital prototype of such an eHealth intervention was developed. Conclusions: The developed eHealth intervention including self-management for reducing sedentary time in older adults transitioning to retirement is intended to facilitate behavior change by encouraging the user to participate in autonomously motivated activities. It uses several behavior change techniques, such as goal setting and action planning through mental contrasting and implementation intention, as well as shaping knowledge. Its active components for reducing sedentary time can be explained using the integrated behavior change model. Further research is needed to evaluate the feasibility and effectiveness of the eHealth intervention. %M 39832361 %R 10.2196/63567 %U https://formative.jmir.org/2025/1/e63567 %U https://doi.org/10.2196/63567 %U http://www.ncbi.nlm.nih.gov/pubmed/39832361 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e53737 %T Completeness of Telehealth Interventions Reporting in Randomized Controlled Trials for Caregivers of People With Dementia: Systematic Review %A Zhu,Ling %A Xing,Yurong %A Xu,Wenhui %A Jia,Hongfei %A Wang,Xiaoxiao %A Liu,Shiqing %A Ding,Yaping %+ Department of Basic and Community Nursing, School of Nursing, Nanjing Medical University, 101 Longmian Avenue, Jiangning District, NanJing, 211166, China, 86 13851646554, dingyp@njmu.edu.cn %K telehealth %K intervention reporting %K dementia %K caregivers %K Template for Intervention Description and Replication %K TIDieR-Telehealth checklist %D 2025 %7 20.1.2025 %9 Review %J J Med Internet Res %G English %X Background: Telehealth interventions can effectively support caregivers of people with dementia by providing care and improving their health outcomes. However, to successfully translate research into clinical practice, the content and details of the interventions must be sufficiently reported in published papers. Objective: This study aims to evaluate the completeness of a telehealth intervention reporting in randomized controlled trials (RCTs) conducted for caregivers of people with dementia. Methods: A systematic search of relevant papers was conducted on July 26, 2023, in 9 electronic databases. RCTs of telehealth interventions for caregivers of people with dementia were included. Two independent researchers extracted the descriptive information and assessed the methodological quality (Cochrane risk of bias tool) and the completeness of reporting of the intervention by using the Template for Intervention Description and Replication (TIDieR)-Telehealth checklist, which consists of 12 items. Results: Thirty-eight eligible RCTs were included finally, and the overall quality of the studies was assessed as moderate. None of the studies completely reported all the TIDieR-Telehealth items. The most frequently reported items were the brief trial name (35/38, 92%), rationale (38/38, 100%), materials and procedures (35/38, 92%), and the modes of delivery (34/38, 90%). The least reported items were the type of location (0/38, 0%), modifications (4/38, 11%), and assessment and improvement of fidelity (9/38, 24%). Conclusions: Many details of the telehealth interventions in RCTs are reported incompletely. Greater adherence to the TIDieR-Telehealth checklist is essential for improving the reporting quality and for facilitating replicability, which has substantial implications for translation into clinical practice. %M 39832360 %R 10.2196/53737 %U https://www.jmir.org/2025/1/e53737 %U https://doi.org/10.2196/53737 %U http://www.ncbi.nlm.nih.gov/pubmed/39832360 %0 Journal Article %@ 2152-7202 %I JMIR Publications %V 17 %N %P e49941 %T Using Community Engagement to Create a Telecoaching Intervention to Improve Self-Management in Adolescents and Young Adults With Cystic Fibrosis: Qualitative Study %A Duncan,Christina L %A Muther,Emily F %A Lindwall,Jennifer J %A Durkin,Kristine %A Ruvalcaba,Elizabeth %A Williamson,Eliza %A Ahrabi-Nejad,Corrine %A Bord,Evelyn %A Green,Angela %A Harrison,Megan L %A Polineni,Deepika %+ Department of Psychology, Oklahoma State University, 406 Psychology Building, Stillwater, OK, 74078, United States, 1 4057447495, Christina.Duncan12@okstate.edu %K cystic fibrosis %K telecoaching %K self-management %K community engagement %K community partner %K intervention development %D 2025 %7 20.1.2025 %9 Original Paper %J J Particip Med %G English %X Background: Adolescents and young adults (AYA) with cystic fibrosis (CF) are at risk for deviating from their daily treatment regimen due to significant time burden, complicated daily therapies, and life stressors. Developing patient-centric, effective, engaging, and practical behavioral interventions is vital to help sustain therapeutically meaningful self-management. Objective: This study aimed to devise and refine a patient-centered telecoaching intervention to foster self-management in AYA with CF using a combination of intervention development approaches, including an evidence- and theory-based approach (ie, applying existing theories and research evidence for behavior change) and a target population–centered approach (ie, intervention refinement based on the perspectives and actions of those individuals who will use it). Methods: AYA with CF, their caregivers, and health professionals from their CF care teams were recruited to take part in focus groups (or individual qualitative interviews) through a video call interface to (1) obtain perspectives on the overall structure and logistics of the intervention (ie, Step 1) and (2) refine the overall framework of the intervention and obtain feedback on feasibility, content, materials, and coach training (ie, Step 2). Qualitative data were analyzed using a reflexive thematic analysis process. Results were used to create and then modify the intervention structure and content in response to community partner input. Results: For Step 1, a total of 31 AYA and 20 clinicians took part in focus groups or interviews, resulting in 2 broad themes: (1) video call experience and (2) logistics and content of intervention. For Step 2, a total of 22 AYA, 18 clinicians, and 11 caregivers completed focus groups or interviews, yielding 3 major themes: (1) intervention structure, (2) intervention materials, and (3) session-specific feedback. Our Step 1 qualitative findings helped inform the structure (eg, telecoaching session frequency and duration) and approach of the telecoaching intervention. Step 2 qualitative results generally suggested that community partners perceived the feasibility and practicality of the proposed telecoaching intervention in promoting self-management in the face of complex treatment regimens. Extensive specific feedback was used to refine our telecoaching intervention before its efficacy testing in subsequent research. The diverse community partner input was critical in optimizing and tailoring our telecoaching intervention. Conclusions: This study documents the methods and results for engaging key community partners in creating an evidence-based behavioral intervention to promote self-management in AYA with CF. Incorporating the lived experiences and perspectives of community partners is essential when devising tailored and patient-centered interventions. %M 39832355 %R 10.2196/49941 %U https://jopm.jmir.org/2025/1/e49941 %U https://doi.org/10.2196/49941 %U http://www.ncbi.nlm.nih.gov/pubmed/39832355 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e56523 %T Public Understanding and Expectations of Digital Health Evidence Generation: Focus Group Study %A Bondaronek,Paulina %A Li,Jingfeng %A Potts,Henry W W %K mobile apps %K digital health %K public expectations %K evidence of effectiveness %K health risk perception %K effectiveness %K health risk %K health app %K public health %K well-being %K public trust %K diagnostic tools %K safety %K mobile phone %D 2025 %7 20.1.2025 %9 %J JMIR Form Res %G English %X Background: The rapid proliferation of health apps has not been matched by a comparable growth in scientific evaluations of their effectiveness, particularly for apps available to the public. This gap has prompted ongoing debate about the types of evidence necessary to validate health apps, especially as the perceived risk level varies from wellness tools to diagnostic aids. The perspectives of the general public, who are direct stakeholders, are notably underrepresented in discussions on digital health evidence generation. Objective: This study aimed to explore public understanding and expectations regarding the evidence required to demonstrate health apps’ effectiveness, including at varying levels of health risk. Methods: A total of 4 focus group discussions were held with UK residents aged 18 years and older, recruited through targeted advertisements to ensure demographic diversity. Participants discussed their views on evidence requirements for 5 hypothetical health apps, ranging from low-risk wellness apps to high-risk diagnostic tools. Focus groups were moderated using a structured guide, and data were analyzed using reflexive thematic analysis to extract common themes. Results: A total of 5 key themes were established: personal needs, app functionality, social approval, expectations of testing, and authority. Participants relied on personal experiences and social endorsements when judging the effectiveness of low-risk digital health interventions, while making minimal reference to traditional scientific evidence. However, as the perceived risk of an app increased, there was a noticeable shift toward preferring evidence from authoritative sources, such as government or National Health Service endorsements. Conclusions: The public have a preference for evidence that resonates on a personal level, but also show a heightened demand for authoritative guidance as the potential risk of digital health interventions increases. These perspectives should guide developers, regulators, and policy makers as they balance how to achieve innovation, safety, and public trust in the digital health landscape. Engaging the public in evidence-generation processes and ensuring transparency in app functionality and testing can bridge the gap between public expectations and regulatory standards, fostering trust in digital health technologies. %R 10.2196/56523 %U https://formative.jmir.org/2025/1/e56523 %U https://doi.org/10.2196/56523 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 14 %N %P e55835 %T The Effect of Combining mHealth and Health Professional–Led Intervention for Improving Health-Related Outcomes in Chronic Diseases: Systematic Review and Meta-Analysis %A Kanai,Masashi %A Miki,Takahiro %A Sakoda,Toshiya %A Hagiwara,Yuta %+ PREVENT Inc, IKKO Shinsakae Building 9F, 1 Aoi, Higashi-ku, Aichi, 461-0004, Japan, 81 527157955, miki.takahiro@prevent.co.jp %K mHealth %K systematic reviews %K meta-analysis %K chronic diseases %K global health %K technology %K health care %K interventions %K chronic conditions %K health care professionals %K World Health Organization %K physical activity %K web-based %D 2025 %7 20.1.2025 %9 Review %J Interact J Med Res %G English %X Background: Chronic diseases such as diabetes and cardiovascular disease are global health challenges, affecting millions of people worldwide. Traditional health care often falls short in chronic disease management. This has led to the exploration of innovative solutions, such as mobile health (mHealth) technologies. mHealth, which leverages mobile and wireless technologies, has the potential to transform health care delivery by providing continuous, accessible, and personalized care. However, the effectiveness of mHealth, particularly when integrated with traditional health care interventions delivered by professionals, warrants comprehensive investigation. Understanding the combined impact of mHealth and professional-led interventions is critical to maximizing the potential of mHealth to improve patient outcomes and adherence. Objective: This study aims to investigate the effectiveness of combining mHealth and health professional–led intervention for improving health-related outcomes in chronic diseases Methods: This systematic review and meta-analysis focused on randomized controlled trials. We searched Web of Science, CENTRAL, MEDLINE, and CINAHL through July 17, 2023. The study targeted patients aged 18 years and older, experiencing at least 1 chronic condition. The interventions were a combination of mHealth and the use of a health care professional. The comparison groups consisted of participants receiving either general care and follow-up or those using mHealth devices without any health care professional involvement. The outcomes measured in this review included hemoglobin A1c (HbA1c), quality of life (QoL), and physical activity. Results: The study included 26 research papers, encompassing 7360 individuals. Meta-analysis was conducted for HbA1c, QoL, and physical activity. For HbA1c, short-term improvement was significant (standardized mean difference [SMD] –0.43; 95% CI –0.64 to –0.21; I2=69%) and medium term (SMD –0.49; 95% CI –0.49 to –0.09; I2=21%). However, in the long term, the improvement was not significant (SMD –0.23; 95% CI –0.49 to 0.03; I2=88%). For QoL, significant improvements were observed in the short term (SMD –0.23; 95% CI –0.42 to –0.05; I2=62%), and in the medium term (SMD –0.16; 95% CI –0.24 to –0.07; I2=0%). In the long term, however, the improvement was not significant (SMD –0.12; 95% CI –0.41 to 0.16; I2=71%). For physical activity, both subjective (questionnaire) and objective (number of steps) outcomes were analyzed. In the short term, subjective outcomes showed significant improvement (SMD 0.31; 95% CI 0.12-0.50; I2=0%), while objective outcomes did not (SMD 0.11; 95% CI –0.05 to 0.27; I2=0%). Medium- and long-term subjective outcomes showed no significant improvement. Meta-analysis for objective outcomes in the medium and long term was not possible due to insufficient studies. Conclusions: This study confirmed short- and medium-term benefits of mHealth combined with professional interventions for HbA1c, QoL, and short-term physical activity, supporting effective chronic disease management. %M 39832160 %R 10.2196/55835 %U https://www.i-jmr.org/2025/1/e55835 %U https://doi.org/10.2196/55835 %U http://www.ncbi.nlm.nih.gov/pubmed/39832160 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e53231 %T Reflections of Foster Youth Engaging in the Co-Design of Digital Mental Health Technology: Duoethnography Study %A Ezimora,Ifunanya %A Lundberg,Tylia %A Miars,Dylan %A Trujeque,Jeruel %A Papias,Ashley %A Del Cid,Margareth V %A Folk,Johanna B %A Tolou-Shams,Marina %+ Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, 1001 Potrero Avenue, San Francisco, CA, 94110, United States, 1 4156029521, johanna.folk@ucsf.edu %K foster youth %K digital health technology %K co-design %K app development %K mental health %K adolescent %K young adult %K mobile health %K mHealth %K foster care %K duoethnography %D 2025 %7 20.1.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Current research on digital applications to support the mental health and well-being of foster youth is limited to theoretical applications for transition-aged foster youth and support platforms developed without intentional input from foster youth themselves. Centering the lived expertise of foster youth in digital solutions is crucial to dismantling barriers to care, leading to an increase in service access and improving mental health outcomes. Co-design centers the intended end users during the design process, creating a direct relationship between potential users and developers. This methodology holds promise for creating tools centered on foster youth, yet little is known about the co-design experience for foster youth. Understanding foster youth’s experience with co-design is crucial to identifying best practices, knowledge of which is currently limited. Objective: The aim of this paper is to reflect on the experiences of 4 foster youth involved in the co-design of FostrSpace, a mobile app designed through a collaboration among foster youth in the San Francisco Bay Area; clinicians and academics from the Juvenile Justice Behavioral Health research team at the University of California, San Francisco; and Chorus Innovations, a rapid technology development platform specializing in participatory design practices. Key recommendations for co-designing with foster youth were generated with reference to these reflections. Methods: A duoethnography study was conducted over a 1-month period with the 4 transition-aged former foster youth co-designers of FostrSpace via written reflections and a single in-person roundtable discussion. Reflections were coded and analyzed via reflexive thematic analysis. Results: In total, 4 main themes were identified from coding of the duoethnography reflections: power and control, resource navigation, building community and safe spaces, and identity. Themes of power and control and resource navigation highlighted the challenges FostrSpace co-designers experienced trying to access basic needs, support from caregivers, and mental health resources as foster youth and former foster youth. Discussions pertaining to building community and safe spaces highlighted the positive effect of foster youth communities on co-designers, and discussions related to identity revealed the complexities associated with understanding and embracing foster youth identity. Conclusions: This duoethnography study highlights the importance of centering the lived expertise of co-designers throughout the app development process. As the digital health field increasingly shifts toward using co-design methods to develop digital mental health technologies for underserved youth populations, we offer recommendations for researchers seeking to ethically and effectively engage youth co-designers. Actively reflecting throughout the co-design process, finding creative ways to engage in power-sharing practices to build community, and ensuring mutual benefit among co-designers are some of the recommended core components to address when co-designing behavioral health technologies for youth. %M 39832159 %R 10.2196/53231 %U https://formative.jmir.org/2025/1/e53231 %U https://doi.org/10.2196/53231 %U http://www.ncbi.nlm.nih.gov/pubmed/39832159 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e58265 %T A Mindfulness-Based App Intervention for Pregnant Women: Qualitative Evaluation of a Prototype Using Multiple Case Studies %A Rizzi,Silvia %A Pavesi,Maria Chiara %A Moser,Alessia %A Paolazzi,Francesca %A Marchesoni,Michele %A Poggianella,Stefania %A Gadotti,Erik %A Forti,Stefano %+ Digital Health Research, Centre for Digital Health & Wellbeing, Fondazione Bruno Kessler, Via Sommarive 18, Trento, 38123, Italy, 39 0461312415, srizzi@fbk.eu %K mindfulness %K promoting well-being %K pregnancy %K eHealth %K mHealth %K mobile apps %K development %K usability %K user-centered design %K well-being %K maternal health %K digital health %K intervention %K design %K preliminary testing %K technology-based %K interview %K multidisciplinary approach %K mother %K women %K WhatsApp %K email %K midwife %D 2025 %7 17.1.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Pregnancy is a complex period characterized by significant transformations. How a woman adapts to these changes can affect her quality of life and psychological well-being. Recently developed digital solutions have assumed a crucial role in supporting the psychological well-being of pregnant women. However, these tools have mainly been developed for women who already present clinically relevant psychological symptoms or mental disorders. Objective: This study aimed to develop a mindfulness-based well-being intervention for all pregnant women that can be delivered electronically and guided by an online assistant with wide reach and dissemination. This paper aimed to describe a prototype technology-based mindfulness intervention’s design and development process for pregnant women, including the exploration phase, intervention content development, and iterative software development (including design, development, and formative evaluation of paper and low-fidelity prototypes). Methods: Design and development processes were iterative and performed in close collaboration with key stakeholders (N=15), domain experts including mindfulness experts (n=2), communication experts (n=2), and psychologists (n=3), and target users including pregnant women (n=2), mothers with young children (n=2), and midwives (n=4). User-centered and service design methods, such as interviews and usability testing, were included to ensure user involvement in each phase. Domain experts evaluated a paper prototype, while target users evaluated a low-fidelity prototype. Intervention content was developed by psychologists and mindfulness experts based on the Mindfulness-Based Childbirth and Parenting program and adjusted to an electronic format through multiple iterations with stakeholders. Results: An 8-session intervention in a prototype electronic format using text, audio, video, and images was designed. In general, the prototypes were evaluated positively by the users involved. The questionnaires showed that domain experts, for instance, positively evaluated chatbot-related aspects such as empathy and comprehensibility of the terms used and rated the mindfulness traces present as supportive and functional. The target users found the content interesting and clear. However, both parties regarded the listening as not fully active. In addition, the interviews made it possible to pick up useful suggestions in order to refine the intervention. Domain experts suggested incorporating auditory components alongside textual content or substituting text entirely with auditory or audiovisual formats. Debate surrounded the inclusion of background music in mindfulness exercises, with opinions divided on its potential to either distract or aid in engagement. The target users proposed to supplement the app with some face-to-face meetings at crucial moments of the course, such as the beginning and the end. Conclusions: This study illustrates how user-centered and service designs can be applied to identify and incorporate essential stakeholder aspects in the design and development process. Combined with evidence-based concepts, this process facilitated the development of a mindfulness intervention designed for the end users, in this case, pregnant women. %M 39625414 %R 10.2196/58265 %U https://formative.jmir.org/2025/1/e58265 %U https://doi.org/10.2196/58265 %U http://www.ncbi.nlm.nih.gov/pubmed/39625414 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e56601 %T Development and Evaluation of a Mindfulness-Based Mobile Intervention for Perinatal Mental Health: Randomized Controlled Trial %A Park,Sehwan %A Cho,Hee Young %A Park,Jin Young %A Chung,Kyungmi %A Jhung,Kyungun %+ Department of Psychiatry, Catholic Kwandong University International St. Mary’s Hospital, Catholic Kwandong University College of Medicine, 25, Simgok-ro 100 Beon-gil, Incheon, 22711, Republic of Korea, 82 1090563807, kyungun12@gmail.com %K anxiety %K perinatal mental health %K depression %K mobile health care %K mindfulness %K mobile phone %D 2025 %7 17.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Perinatal mental health problems, such as anxiety, stress, and depression, warrant particularly close monitoring and intervention, but they are often unaddressed in both obstetric and psychiatric clinics, with limited accessibility and treatment resources. Mobile health interventions may provide an effective and more accessible solution for addressing perinatal mental health. Development and evaluation of a mobile mental health intervention specifically for pregnant women are warranted. Objective: This study aimed to evaluate the effectiveness of a 4-week, self-administered mobile mindfulness intervention in reducing anxiety, depression, and stress, and improving emotional well-being, maternal-fetal attachment, and mindfulness skills in a general population of pregnant women. Methods: Pregnant women were recruited and randomized to an intervention or a wait-list control group. The intervention group participated in a self-administered 4-week smartphone-based mindfulness program. Anxiety, depression, and stress were assessed as primary outcomes at baseline and postintervention. Secondary outcomes were mental health well-being, maternal-fetal attachment, and skills of mindfulness. The usability of the mobile intervention was also evaluated. Results: A total of 133 pregnant women were randomly assigned to the intervention (n=66) or the control group (n=67). The overall dropout rate was 30% (39/133). Anxiety scores of the intervention group significantly decreased from baseline to postintervention (P=.03, Wilcoxon Signed-Rank test), whereas no significant changes were observed in the control group. Depression and stress scores showed no significant changes. Emotional well-being significantly improved in the intervention group (P=.01). Improvements were observed in maternal-fetal attachment, particularly in attributing characteristics to the fetus (P=.003) and in differentiating the self from the fetus (P=.006). Mindfulness awareness also showed significant improvement (P=.008). Significant between-group effects were identified for mindfulness awareness (P=.006) and attributing characteristics to the fetus (P=.002). After applying the false discovery rate corrections, within-group improvements in emotional well-being, maternal-fetal attachment, and mindfulness awareness remained significant, while between-group differences for emotional well-being and differentiation were not significant. Conclusions: A mobile mindfulness program effectively reduced anxiety and improved emotional well-being, maternal-fetal attachment, and mindfulness awareness in the general population of pregnant women. Mobile interventions may offer a cost-effective and feasible method for promoting perinatal mental health. Trial Registration: Clinical Research Information Service KCT0007166; https://tinyurl.com/458vfc4r %M 39823585 %R 10.2196/56601 %U https://www.jmir.org/2025/1/e56601 %U https://doi.org/10.2196/56601 %U http://www.ncbi.nlm.nih.gov/pubmed/39823585 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e66442 %T Early Intervention for Children With Developmental Disabilities and Their Families via Telehealth: Systematic Review %A Shin,Yoomi %A Park,Eun Ju %A Lee,Anna %+ Mo-Im Kim Nursing Research Institute, College of Nursing, Yonsei University, 50-1, Yonsei-Ro, Seodaemun-gu, Seoul, 03722, Republic of Korea, 82 2 2228 3284, annalee@yuhs.ac %K developmental disabilities %K developmental delay %K early intervention %K telehealth %K digital intervention %K autistic spectrum disorder %K cerebral palsy %K family-centered care %K multidisciplinary care %K systematic review %D 2025 %7 17.1.2025 %9 Review %J J Med Internet Res %G English %X Background: Early intervention during the first 3 years of life is crucial for children with developmental disabilities to optimize developmental outcomes. However, access to such services is often limited by geographical distance and resource constraints. Telehealth can be part of a solution for overcoming these barriers, enabling the delivery of early intervention services. However, a comprehensive understanding of the efficacy and implementation of telehealth in early interventions remains elusive, particularly for children aged 0-3 years. Objective: This systematic review aims to synthesize existing research on the effectiveness and implementation of telehealth interventions in infants and toddlers (aged 0–3 years) who are at risk of or diagnosed with developmental disabilities. The primary objective of the study is to evaluate the ways that telehealth compares to conventional in-person interventions in improving developmental outcomes for children and supporting family well-being. Methods: A systematic search was conducted of 4 electronic databases (PubMed, Embase, CINAHL, and Web of Science), focusing on studies published between 2010 and 2024. The inclusion criteria were studies involving telehealth interventions for children aged 0-3 years who were at high risk or had developmental disabilities, which involved active interactions between the providers and the families. Study quality was assessed using the mixed methods appraisal tool, and a narrative synthesis was used to analyze the data. Results: Eighteen studies met the inclusion criteria: 12 single-case designs, 4 randomized controlled trials, and 2 nonequivalent control group designs. All studies involved caregiver-child dyads, with child ages ranging from 5 to 37 months and having or at risk of autistic spectrum disorder (n=10, 56%), cerebral palsy (n=4, 22%), and other conditions (n=4, 22%). Synchronous videoconferencing was the primary modality for caregiver training and coaching (n=17, 94%) while 1 intervention used an Internet of Things system. Outcomes were identified in child communication (n=9, 50%), physical (n=6, 33%), social or emotional (n=6, 33%), and adaptive behavior (n=4, 22%), as well as caregiver implementation (n=12, 66%). Telehealth demonstrated comparable or superior effectiveness to traditional in-person methods in 2 studies. However, the focus on specific conditions and limited research on cognitive development were notable gaps. Conclusions: Telehealth can be a viable alternative to traditional in-person early interventions for young children who have developmental disabilities and their families. It enhances accessibility and interactions between families and providers at a distance while promoting family-centered care. Challenges exist, including those of technological literacy, and the lack of research on cognitive outcomes must be addressed. Future work should explore more comprehensive interventions, including multidisciplinary approaches and expanded family outcomes, to solidify the role that telehealth plays in early intervention. Trial Registration: PROSPERO CRD42024551286; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=551286 %M 39819975 %R 10.2196/66442 %U https://www.jmir.org/2025/1/e66442 %U https://doi.org/10.2196/66442 %U http://www.ncbi.nlm.nih.gov/pubmed/39819975 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 11 %N %P e59464 %T Developing and Assessing a Scalable Digital Health Tool for Pretest Genetic Education in Patients With Early-Onset Colorectal Cancer: Mixed Methods Design %A Rivera Rivera,Jessica N %A Snir,Moran %A Simmons,Emilie %A Schmidlen,Tara %A Sholeh,Misha %A Maconi,Melinda Leigh %A Geiss,Carley %A Fulton,Hayden %A Barton,Laura %A Gonzalez,Brian D %A Permuth,Jennifer %A Vadaparampil,Susan %+ Healthcare Delivery Research Network, MedStar Health Research Institute, 100 Irving Street NW, Washington, DC, 20010, United States, 1 443 692 1138, jessica.n.riverarivera@medstar.net %K genetic education %K genetic testing %K genetic counseling %K digital health %K early-onset colorectal cancer %D 2025 %7 17.1.2025 %9 Original Paper %J JMIR Cancer %G English %X Background: National guidelines recommend germline genetic testing (GT) for all patients with early-onset colorectal cancer. With recent advances in targeted therapies and GT, these guidelines are expected to expand to include broader groups of patients with colorectal cancer. However, there is a shortage of genetic professionals to provide the necessary education and support for informed consent. As such, there is a pressing need to identify alternative approaches to facilitate and expedite access to GT. Objective: This study describes the development of a pretest education intervention, Nest-CRC, to facilitate the uptake of germline GT among patients with early-onset colorectal cancer. Patients with early-onset colorectal cancer and health care providers reviewed Nest-CRC, and their reactions and recommendations were captured using a nested mixed methods approach. Methods: Using the learner verification approach, we conducted 2 sequential phases of surveys and interviews with English- and Spanish-speaking patients with early-onset colorectal cancer and health care providers. The surveys assessed participants’ experiences with genetic services and provided immediate feedback on the Nest-CRC genetic education modules. Semistructured interviews evaluated participants’ perceptions of self-efficacy, attraction, comprehension, cultural acceptability, and usability of Nest-CRC. Survey data were analyzed using descriptive statistics (mean, median, and proportions), while interview data were analyzed through line-by-line coding of the transcribed interviews. After each phase, Nest-CRC was refined based on participants’ recommendations. Results: A total of 52 participants, including 39 patients with early-onset colorectal cancer and 13 providers, participated in the study. Of these, 19 patients and 6 providers participated in phase 1 (N=25), and 20 patients and 7 providers participated in phase 2 (N=27). Most participants (phase 1: 23/25, 92%, to 25/25, 100%; phase 2: 24/27, 89%, to 27/27, 100%) agreed that each of the 5 education modules was easy to understand and helpful; 13 patients reported no history of GT, with 11 (85%) expressing interest in GT and 2 (15%) remaining unsure after completing Nest-CRC. Participants reported that Nest-CRC provided sufficient information to help them decide about GT. The tool was deemed acceptable by individuals from diverse backgrounds, and participants found it visually attractive, easy to comprehend, and user-friendly. Conclusions: The findings revealed that Nest-CRC is a promising strategy for facilitating pretest education and promoting GT. Nest-CRC has been refined based on participant recommendations and will be re-evaluated. %M 39819811 %R 10.2196/59464 %U https://cancer.jmir.org/2025/1/e59464 %U https://doi.org/10.2196/59464 %U http://www.ncbi.nlm.nih.gov/pubmed/39819811 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 11 %N %P e54154 %T Benefits of Remote-Based Mindfulness on Physical Symptom Outcomes in Cancer Survivors: Systematic Review and Meta-Analysis %A Komariah,Maria %A Maulana,Sidik %A Amirah,Shakira %A Platini,Hesti %A Rahayuwati,Laili %A Yusuf,Ah %A Firdaus,Mohd Khairul Zul Hasymi %K cancer %K physical symptoms %K mindfulness %K remote-based intervention %K quality of life %D 2025 %7 16.1.2025 %9 %J JMIR Cancer %G English %X Background: Many cancer survivors experience a wide range of symptoms closely linked to psychological problems, highlighting the need for psychological treatment, one of the most popular being mindfulness. The use of the internet has greatly increased in the last decade, and has encouraged the use of remote-based interventions to help people living with cancer access treatment remotely via devices. Objective: The primary aim of this study was to explore the efficacy of internet-based mindfulness interventions on the physical symptoms of people living with cancer, where physical symptoms are defined as distressing somatic experiences (eg fatigue, insomnia, and pain) regardless of the underlying cause. The secondary aim was to investigate interventions for the quality of life (QoL). Methods: This study followed the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines. Relevant articles were systematically searched using electronic databases, namely Scopus, Medline through PubMed, Cumulated Index in Nursing and Allied Health Literature (CINAHL) through EBSCOhost, and Cochrane Central Database. Randomized controlled and pilot trials involving adults and/or older adults with cancer and using remote-based mindfulness interventions compared to usual care were included. The quality of the trials included in this study was assessed using the revised Cochrane risk of bias, version 2.0. This study estimated the standardized mean difference (SMD) and mean difference (MD) with 95% CI. The I2 test was used to identify potential causes of heterogeneity. Publication bias was assessed using contour-enhanced funnel plots and the Egger linear regression test to reveal a small study effect. Results: The initial search yielded 1985 records, of which 13 studies were ultimately included. After treatment, remote-based mindfulness significantly reduced fatigue (SMD −0.94; 95% CI: −1.56 to −0.33; P=.002), sleep disturbance (SMD −0.36; 95% CI: −0.60 to −0.12; P=.004), and improved physical function (SMD .25; 95% CI: 0.09 to 0.41; P=.002) compared to that observed before treatment. However, compared with usual care, remote-based mindfulness showed a statistically significant reduction only in sleep disturbance (SMD: −0.37; 95% CI: −0.58 to −0.16; P=.0006) after treatment. Moreover, remote-based mindfulness was not statistically significant in reducing pain both within and between groups. Conclusions: Remote-based mindfulness shows promise in reducing sleep disturbances; however, its impact on fatigue, pain, and physical function may be limited. %R 10.2196/54154 %U https://cancer.jmir.org/2025/1/e54154 %U https://doi.org/10.2196/54154 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 13 %N %P e50635 %T Gamified Web-Delivered Attentional Bias Modification Training for Adults With Chronic Pain: Randomized, Double-Blind, Placebo-Controlled Trial %A Vermeir,Julie F %A White,Melanie J %A Johnson,Daniel %A Crombez,Geert %A Van Ryckeghem,Dimitri M L %+ School of Psychology and Counselling, Faculty of Health, Queensland University of Technology (QUT), 170 Victoria Park Road., Brisbane, 4059, Australia, 61 731384714, julie.vermeir@hdr.qut.edu.au %K chronic pain %K cognition %K attentional bias %K gamification %K motivation %K randomized controlled trial %K web-based intervention %K pain management %K digital intervention %K digital health %D 2025 %7 16.1.2025 %9 Original Paper %J JMIR Serious Games %G English %X Background: Attentional bias to pain-related information has been implicated in pain chronicity. To date, research investigating attentional bias modification training (ABMT) procedures in people with chronic pain has found variable success, perhaps because training paradigms are typically repetitive and monotonous, which could negatively affect engagement and adherence. Increasing engagement through the gamification (ie, the use of game elements) of ABMT may provide the opportunity to overcome some of these barriers. However, ABMT studies applied to the chronic pain field have not yet incorporated gamification elements. Objective: This study aimed to investigate the effects of a gamified web-delivered ABMT intervention in a sample of adults with chronic pain via a randomized, double-blind, placebo-controlled trial. Methods: A final sample of 129 adults with chronic musculoskeletal pain, recruited from clinical (hospital outpatient waiting list) and nonclinical (wider community) settings, were included in this randomized, double-blind, placebo-controlled, 3-arm trial. Participants were randomly assigned to complete 6 web-based sessions of nongamified standard ABMT (n=43), gamified ABMT (n=41), or a control condition (nongamified sham ABMT; n=45) over a period of 3 weeks. Active ABMT conditions trained attention away from pain-related words. The gamified task included a combination of 5 game elements. Participant outcomes were assessed before training, during training, immediately after training, and at 1-month follow-up. Primary outcomes included self-reported and behavioral engagement, pain intensity, and pain interference. Secondary outcomes included anxiety, depression, cognitive biases, and perceived improvement. Results: Results of the linear mixed model analyses suggest that across all conditions, there was an overall small to medium decline in self-reported task-related engagement between sessions 1 and 2 (P<.001; Cohen d=0.257; 95% CI 0.13-0.39), sessions 1 and 3 (P<.001; Cohen d=0.368; 95% CI 0.23-0.50), sessions 1 and 4 (P<.001; Cohen d=0.473; 95% CI 0.34-0.61), sessions 1 and 5 (P<.001; Cohen d=0.488; 95% CI 0.35-0.63), and sessions 1 and 6 (P<.001; Cohen d=0.596; 95% CI 0.46-0.73). There was also an overall small decrease in depressive symptoms from baseline to posttraining assessment (P=.007; Cohen d=0.180; 95% CI 0.05-0.31) and in pain intensity (P=.008; Cohen d=0.180; 95% CI 0.05-0.31) and pain interference (P<.001; Cohen d=0.237; 95% CI 0.10-0.37) from baseline to follow-up assessment. However, no differential effects were observed over time between the 3 conditions on measures of engagement, pain intensity, pain interference, attentional bias, anxiety, depression, interpretation bias, or perceived improvement (all P values>.05). Conclusions: These findings suggest that gamification, in this context, was not effective at enhancing engagement, and they do not support the widespread clinical use of web-delivered ABMT in treating individuals with chronic musculoskeletal pain. The implications of these findings are discussed, and future directions for research are suggested. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000803998; https://anzctr.org.au/ACTRN12620000803998.aspx International Registered Report Identifier (IRRID): RR2-10.2196/32359 %M 39819575 %R 10.2196/50635 %U https://games.jmir.org/2025/1/e50635 %U https://doi.org/10.2196/50635 %U http://www.ncbi.nlm.nih.gov/pubmed/39819575 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e63737 %T Mobile Phone App to Promote Lifestyle Change in People at Risk of Type 2 Diabetes: Feasibility 3-Arm Randomized Controlled Trial %A Skoglund,Gyri %A Hilde,Gunvor %A Lunde,Pernille %A Cruz Naceno,Venessa Vera %A Fromholt Olsen,Cecilie %A Blakstad Nilsson,Birgitta %K prevention %K risk of type 2 diabetes %K lifestyle change %K feasibility %K app adherence %K mobile health %K mHealth %K mobile phone %D 2025 %7 15.1.2025 %9 %J JMIR Form Res %G English %X Background: The use of mobile health interventions, such as apps, are proposed to meet the challenges faced by preventive health care services due to the increasing prevalence of type 2 diabetes (T2D). Thus, we developed and conducted initial feasibility testing of the Plunde app for promoting and monitoring individual goals related to lifestyle change for people at risk of T2D. Objective: The primary aim of this study was to assess the feasibility of an app for promoting lifestyle change in people at risk of T2D. The secondary aim was to assess recruitment rate, resource requirements, and change in potential outcomes for a full scale randomized controlled trial (RCT) study . Methods: A 3-arm feasibility RCT lasting 12 weeks was designed. Participants were recruited from 9 general practitioners in Norway. Eligible participants were randomized to either (1) app follow-up; (2) app follow-up and referral to care as usual in Healthy Life Centers; or (3) referral to care as usual in a Healthy Life Center, only. The primary outcome was feasibility and was measured by app adherence (actual usage of the app), the System Usability Scale, and app motivation score gained from a questionnaire designed for this study. Criteria for success were preset based on these measures. Secondary outcomes included recruitment rate, resource requirements, and potential primary outcomes of a full-scale RCT. This included change in body weight, waist circumference, and self-evaluated functional health status, assessed with the Dartmouth Primary Care Cooperative Research Network/World Organization of Family Doctors (COOP/WONCA) functional health assessment chart. Results: Within 8 months, 9 general practitioners recruited a total of 54 participants, of which 45 were eligble for participation in the study. Mean age was 61 (SD 13) years and 53% (n=24) were female. App adherence was 86%, the mean System Usability Scale score was 87.3 (SD 11.9), and the mean app motivation score was 74.8 (SD 30.3). Throughout the intervention period, health care professionals spent on average 3.0 (SD 1.0) minutes per participant per week providing follow-up. Statistically significant reduction in body weight and waist circumference was shown in group 1 and 3. Conclusions: Based on the preset criteria for success, the Plunde app is feasible in providing support for lifestyle change. The Plunde app had excellent user satisfaction. The amount of time spent on monitoring and promoting lifestyle change through the app was low; however, the recruitment was slow. Results from this study will guide the development of further research within this field. Trial Registration: ClinicalTrials.gov NCT06117098; https://clinicaltrials.gov/study/NCT06117098 %R 10.2196/63737 %U https://formative.jmir.org/2025/1/e63737 %U https://doi.org/10.2196/63737 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 13 %N %P e53971 %T Smoking Cessation Smartphone App for Nondaily Smoking With Telephone Onboarding: Proof-of-Concept Randomized Controlled Trial %A Hoeppner,Bettina B %A Siegel,Kaitlyn R %A Futter,Allison E %A Finley-Abboud,Diadora %A Williamson,Alivia C %A Kahler,Christopher W %A Park,Elyse R %A Hoeppner,Susanne S %+ Health through Flourishing (HtF) program, Department of Psychiatry, Massachusetts General Hospital, 125 Nashua St, 4th Fl., Boston, MA, 02114, United States, 1 617 643 198, bhoeppner@mgh.harvard.edu %K mobile health %K mHealth %K smoking cessation %K nondaily smoking %K smartphone %K smoking %K positive psychology %K mobile phone %D 2025 %7 15.1.2025 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Nondaily smoking is a widespread and increasingly prevalent pattern of use. To date, no effective treatment approach for nondaily smoking has been identified. Objective: This study aimed to conduct an unblinded randomized controlled trial to evaluate proof-of-concept markers of the Smiling instead of Smoking (SiS) app, a smartphone app for smoking cessation, designed specifically for people who smoke less than daily, within the framework of positive psychology. Methods: Overall, 226 adults who smoke less than daily were recruited on the web and asked to undertake a quit attempt while using assigned smoking cessation support materials. Participants were randomly assigned to 1 of 3 materials: the SiS smartphone app, the National Cancer Institute’s smartphone app QuitGuide (QG), or the National Cancer Institute’s smoking cessation brochure, “Clearing the Air” (CtA). All participants engaged in a 15-minute scripted onboarding phone call and were introduced to their support materials to use for the next 7 weeks. Follow-up self-assessment web surveys were sent 2, 6, 12, and 24 weeks after participants’ initially chosen quit date (ie, 1 week after onboarding). The primary outcome for this study was self-efficacy to remain abstinent from smoking at treatment end. Secondary outcomes assessed treatment acceptability, treatment feasibility (eg, number of days of app use, time spent using app, and use of smoking cessation strategies), and secondary proof-of-concept efficacy outcomes (eg, positive affect, craving, and attitudes toward smoking). Smoking outcomes (ie, 30-day point prevalence abstinence and smoking reduction) were also assessed. Results: Results indicated a significant effect of treatment on the primary outcome, where SiS participants (n=80) reported higher self-efficacy to abstain from smoking at the end of treatment than the 2 control groups (QG: n=75; P=.02; Cohen d=0.40 and CtA: n=71; P=.007; Cohen d=0.50). This effect was also significant on both self-efficacy subscales (ie, internal cues and external cues) with effect sizes ranging from Cohen d=0.34 to 0.50 across the pairwise comparisons. The SiS app group also reported lower craving (QG: P=.005; Cohen d=–0.57 and CtA: P=.005; Cohen d=–0.57) and higher positive affect than QG (QG: P=.01; Cohen d=0.44 and CtA: P=.05; Cohen d=0.38); attitudes toward smoking were largely similar across groups. Treatment acceptability was comparable across groups (P values for all groups >.05; Cohen d range 0.06-0.23). Treatment feasibility measures indicated that participants used the SiS app on 33 out of 49 days, for 35 to 40 minutes per week, resulting in greater use of smoking cessation strategies than QG (QG: P=.04; Cohen d=0.38 and CtA: P=.16; Cohen d=0.24). Conclusions: These findings provide strong evidence for the conceptual underpinnings of the SiS app, and thereby provide compelling justification for conducting a large-scale randomized controlled trial that can test the effectiveness of the SiS app on smoking cessation. Trial Registration: ClinicalTrials.gov NCT04672239; https://clinicaltrials.gov/study/NCT04672239 International Registered Report Identifier (IRRID): RR2-10.2196/40867 %M 39814363 %R 10.2196/53971 %U https://mhealth.jmir.org/2025/1/e53971 %U https://doi.org/10.2196/53971 %U http://www.ncbi.nlm.nih.gov/pubmed/39814363 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e65122 %T Weight Loss Patterns and Outcomes Over 12 Months on a Commercial Weight Management Program (CSIRO Total Wellbeing Diet Online): Large-Community Cohort Evaluation Study %A Hendrie,Gilly A %A Baird,Danielle L %A James-Martin,Genevieve %A Brindal,Emily %A Brooker,Paige G %+ Commonwealth Scientific and Industrial Research Organisation, PO Box 10041, Adelaide, 5000, Australia, 61 883050662, gilly.hendrie@csiro.au %K obesity %K obesity management %K weight loss %K internet-based intervention, weight management %D 2025 %7 15.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: A greater understanding of the effectiveness of digital self-management programs and their ability to support longer-term weight loss is needed. Objective: This study aimed to explore the total weight loss and patterns of weight loss of CSIRO (Commonwealth Scientific and Industrial Research Organisation) Total Wellbeing Diet Online members during their first 12 months of membership and examine the patterns of platform use associated with greater weight loss. Methods: Participants were Australian adults who joined the program between October 2014 and June 2022 and were classified as longer-term members, meaning they completed at least 12 weeks of the program, had baseline and 12-week weight data, and had a paid membership of ≥1 year (N=24,035). Weight loss and percentage of starting body weight loss were calculated at 3, 6, 9, and 12 months using 3 statistical approaches: (1) multiple imputations method, (2) all available data, and (3) complete data only. Among members with complete data (6602/24,035, 27.5%), patterns of weight loss and gain were examined, and how this related to total weight loss and platform use was explored. Results: Members were mostly female (19,972/24,035, 83.09%), aged 31 to 50 years (9986/24,035, 41.5%) or 51 to 70 years (12,033/24,035, 50.06%), and most members were classified as overweight or obese (23,050/24,035, 95.9%). Using multiple imputations, the average estimated weight loss was 5.9 (SE 0.0245) kg at 12 weeks, 6.7 (SE 0.0348) kg at 6 months, 6.2 (SE 0.0400) kg at 9 months, and 5.5 (SE 0.0421) kg at 12 months. At 12 months, more than half the members (12,573/24,035, 52.3%) were at least 5% below their starting body weight and 1 in 4 (5865/24,035, 24.4%) were at least 10% below their starting body weight. In the subsample with complete data, the average weight loss at 12 months was 7.8 kg. The most common (961/6602, 14.56% members) weight loss pattern over the first 12 months was 6 months of weight loss, followed by 6 months of weight maintenance. This group had an average weight loss of 10.6 kg at 12 months (11.9% of their starting body weight). In a subgroup of participants who consistently lost weight over the 12-month period (284/6602, 4.3% of the sample), weight loss reached up to 22.3 kg (21.7% of their starting body weight). Weekly platform use was positively associated with total weight loss (r=0.287; P<.001). Members who used the platform >30 times per week (approximately >4 times/d) were more likely to lose weight in the first 6 months of the program. Conclusions: This commercial weight loss program was shown to be effective, with 1 in 2 members achieving clinically significant results after 1 year. Greater engagement with the platform was associated with consecutive periods of weight loss and greater weight loss success overall. %R 10.2196/65122 %U https://www.jmir.org/2025/1/e65122 %U https://doi.org/10.2196/65122 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e55586 %T Patient-Centered mHealth Intervention to Improve Self-Care in Patients With Chronic Heart Failure: Phase 1 Randomized Controlled Trial %A Kitsiou,Spyros %A Gerber,Ben S %A Buchholz,Susan W %A Kansal,Mayank M %A Sun,Jiehuan %A Pressler,Susan J %+ University of Illinois Chicago, 1919 W Taylor Street, MC 530, Chicago, IL, 60612, United States, 1 312 355 3519, skitsiou@uic.edu %K mHealth %K app %K digital health %K telehealth %K text messaging %K smartphone %K wearable electronic devices %K heart failure %K self-care %K self-management %K randomized controlled trial %K cardiology %K SMS %D 2025 %7 15.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Heart failure (HF) is one of the most common causes of hospital readmission in the United States. These hospitalizations are often driven by insufficient self-care. Commercial mobile health (mHealth) technologies, such as consumer-grade apps and wearable devices, offer opportunities for improving HF self-care, but their efficacy remains largely underexplored. Objective: The objective of this study was to examine the feasibility, acceptability, safety, and preliminary efficacy of a patient-centered mHealth intervention (iCardia4HF) that integrates 3 consumer mHealth apps and devices (Heart Failure Health Storylines, Fitbit, and Withings) with a program of individually tailored SMS text messages to improve HF self-care. Methods: We conducted a phase 1 randomized controlled trial. Eligible patients had stage C HF, were aged ≥40 years, and had New York Heart Association (NYHA) class I, II, or III HF. Patients were randomly assigned to either iCardia4HF plus usual care or to usual care only and were observed for 8 weeks. Key feasibility measures were recruitment and retention rates. The primary efficacy outcome was change in HF self-care subscale scores (maintenance, symptom perception, and self-care management) at 8 weeks, assessed with the Self-Care Heart Failure Index (SCHFI; version 7.2). Key secondary outcomes were modifiable behaviors targeted by the intervention (health beliefs, self-efficacy, and HF knowledge), health status, and adherence to daily self-monitoring of 2 core vital signs (body weight and blood pressure). Results: A total of 27 patients were enrolled in the study and randomly assigned to iCardia4HF (n=13, 48%) or usual care (n=14, 52%). Of these 27 patients, 11 (41%) in the intervention group (iCardia4HF) and 14 (52%) in the usual care group started their assigned care and were included in the full analysis. Patients’ mean age was 56 (SD 8.3) years, 44% (11/25) were female, 92% (23/25) self-reported race as Black, 76% (19/25) had NYHA class II or III HF, and 60% (15/25) had HF with reduced left ventricular ejection fraction. Participant retention, completion of study visits, and adherence to using the mHealth apps and devices for daily self-monitoring were high (>80%). At 8 weeks, the mean group differences in changes in the SCHFI subscale scores favored the intervention over the control group: maintenance (Cohen d=0.19, 95% CI –0.65 to 1.02), symptom perception (Cohen d=0.33, 95% CI –0.51 to 1.17), and self-care management (Cohen d=0.25, 95% CI –0.55 to 1.04). The greatest improvements in terms of effect size were observed in self-efficacy (Cohen d=0.68) and health beliefs about medication adherence (Cohen d=0.63) and self-monitoring adherence (Cohen d=0.94). There were no adverse events due to the intervention. Conclusions: iCardia4HF was found to be feasible, acceptable, and safe. A larger trial with a longer follow-up duration is warranted to examine its efficacy among patients with HF. Trial Registration: ClinicalTrials.gov NCT03642275; https://clinicaltrials.gov/study/NCT03642275 %M 39813671 %R 10.2196/55586 %U https://www.jmir.org/2025/1/e55586 %U https://doi.org/10.2196/55586 %U http://www.ncbi.nlm.nih.gov/pubmed/39813671 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 12 %N %P e51022 %T Determinants of Dropout From a Virtual Agent–Based App for Insomnia Management in a Self-Selected Sample of Users With Insomnia Symptoms: Longitudinal Study %A Sanchez Ortuño,María Montserrat %A Pecune,Florian %A Coelho,Julien %A Micoulaud-Franchi,Jean Arthur %A Salles,Nathalie %A Auriacombe,Marc %A Serre,Fuschia %A Levavasseur,Yannick %A De Sevin,Etienne %A Sagaspe,Patricia %A Philip,Pierre %K insomnia %K digital behavioral therapy %K mobile health %K dropout %K virtual agent–based app %K virtual agent %K user %K digital intervention %K smartphone %K mental health %K implementation %K cognitive behavioral therapy %K CBT %D 2025 %7 15.1.2025 %9 %J JMIR Ment Health %G English %X Background: Fully automated digital interventions delivered via smartphone apps have proven efficacious for a wide variety of mental health outcomes. An important aspect is that they are accessible at a low cost, thereby increasing their potential public impact and reducing disparities. However, a major challenge to their successful implementation is the phenomenon of users dropping out early. Objective: The purpose of this study was to pinpoint the factors influencing early dropout in a sample of self-selected users of a virtual agent (VA)–based behavioral intervention for managing insomnia, named KANOPEE, which is freely available in France. Methods: From January 2021 to December 2022, of the 9657 individuals, aged 18 years or older, who downloaded and completed the KANOPEE screening interview and had either subclinical or clinical insomnia symptoms, 4295 (44.5%) dropped out (ie, did not return to the app to continue filling in subsequent assessments). The primary outcome was a binary variable: having dropped out after completing the screening assessment (early dropout) or having completed all the treatment phases (n=551). Multivariable logistic regression analysis was used to identify predictors of dropout among a set of sociodemographic, clinical, and sleep diary variables, and users’ perceptions of the treatment program, collected during the screening interview. Results: The users’ mean age was 47.95 (SD 15.21) years. Of those who dropped out early and those who completed the treatment, 65.1% (3153/4846) were women and 34.9% (1693/4846) were men. Younger age (adjusted odds ratio [AOR] 0.98, 95% CI 0.97‐0.99), lower education level (compared to middle school; high school: AOR 0.56, 95% CI 0.35‐0.90; bachelor’s degree: AOR 0.35, 95% CI 0.23‐0.52; master’s degree or higher: AOR 0.35, 95% CI 0.22‐0.55), poorer nocturnal sleep (sleep efficiency: AOR 0.64, 95% CI 0.42‐0.96; number of nocturnal awakenings: AOR 1.13, 95% CI 1.04‐1.23), and more severe depression symptoms (AOR 1.12, 95% CI 1.04‐1.21) were significant predictors of dropping out. When measures of perceptions of the app were included in the model, perceived benevolence and credibility of the VA decreased the odds of dropout (AOR 0.91, 95% CI 0.85‐0.97). Conclusions: As in traditional face-to-face cognitive behavioral therapy for insomnia, the presence of significant depression symptoms plays an important role in treatment dropout. This variable represents an important target to address to increase early engagement with fully automated insomnia management programs. Furthermore, our results support the contention that a VA can provide relevant user stimulation that will eventually pay out in terms of user engagement. Trial Registration: ClinicalTrials.gov NCT05074901; https://clinicaltrials.gov/study/NCT05074901?a=1 %R 10.2196/51022 %U https://mental.jmir.org/2025/1/e51022 %U https://doi.org/10.2196/51022 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e59154 %T Considering Comorbidities and Individual Differences in Testing a Gaming Behavioral Activation App for Perinatal Depression and Anxiety: Open Trial Pilot Intervention Study %A Hamlett,Gabriella E %A Schrader,Chloe %A Ferguson,Craig %A Kobylski,Lauren A %A Picard,Rosalind %A Locascio,Joseph J %A McNally,Richard J %A Cohen,Lee S %A Vanderkruik,Rachel %K perinatal anxiety %K perinatal depression %K behavioral activation %K digital mental health %K mobile phone %D 2025 %7 14.1.2025 %9 %J JMIR Form Res %G English %X Background: There is increasing interest in the development of scalable digital mental health interventions for perinatal populations to increase accessibility. Mobile behavioral activation (BA) is efficacious for the treatment of perinatal depression; however, the effect of comorbid anxiety and depression (CAD) on symptom trajectories remains underexplored. This is important given that at least 10% of women in the perinatal period experience CAD. Objective: We assessed whether there were differences in symptom trajectories in pregnant participants with CAD as compared to those with depression only (ie, major depressive disorder [MDD]) during intervention with a BA mobile gaming app. Methods: Pregnant adults with either CAD (n=10) or MDD (n=7) used a BA app for 10 weeks and completed biweekly symptom severity questionnaires for depression and anxiety. We assessed whether baseline diagnoses were associated with differential symptom trajectories across the study with mixed effects longitudinal models. Results: When controlling for baseline symptoms, results revealed a significant interaction between baseline diagnosis and the quadratic component of study week on anxiety (β=.18, SE 0.07; t62=2.61; P=.01), revealing a tendency for anxiety in the CAD group to increase initially and then decrease at an accelerated rate, whereas MDD symptoms were relatively stable across time. There was a significant effect of linear time on depression (β=−.39, SE 0.11; t68=−3.51; P=.001), showing that depression declined steadily across time for both groups. There was a significant effect of baseline diagnosis on depression (β=−8.53, SE 3.93; t13=−2.17; P=.05), suggesting that those with MDD had higher follow-up depression compared to those with CAD when holding other predictors constant. Conclusions: The app was beneficial in reducing depression symptoms in perinatal individuals with different comorbidity profiles. With respect to anxiety symptom trajectories, however, there was more variability. The app may be especially effective for the treatment of anxiety symptoms among individuals with CAD, as it encourages in-the-moment ecologically relevant exposure to anxiety-provoking stimuli. Despite no significant group difference in baseline anxiety symptoms, the MDD group did not have a significant reduction in their anxiety symptoms across the study period, and some individuals had an increase in anxiety. Findings may point to opportunities for the augmentation of BA gaming apps for those with MDD to more effectively target anxiety symptoms. Overall, findings suggest there may be value in considering comorbidities and individual variations in participants when developing scalable mobile interventions for perinatal populations. %R 10.2196/59154 %U https://formative.jmir.org/2025/1/e59154 %U https://doi.org/10.2196/59154 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e66181 %T Acceptance, Safety, and Effect Sizes in Online Dialectical Behavior Therapy for Borderline Personality Disorder: Interventional Pilot Study %A Vonderlin,Ruben %A Boritz,Tali %A Claus,Carola %A Senyüz,Büsra %A Mahalingam,Saskia %A Tennenhouse,Rachel %A Lis,Stefanie %A Schmahl,Christian %A Margraf,Jürgen %A Teismann,Tobias %A Kleindienst,Nikolaus %A McMain,Shelley %A Bohus,Martin %+ Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, J5, Mannheim, 68159, Germany, 49 621 1703 4445, ruben.vonderlin@zi-mannheim.de %K dialectical behavior therapy %K borderline personality disorder %K online psychotherapy %K virtual psychotherapy %K telehealth %K personality disorders %K mental %K psychotherapy %K online %K internet %K telemedicine %K psychiatry %K psychiatric %K acceptance %D 2025 %7 14.1.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: The potential of telehealth psychotherapy (ie, the online delivery of treatment via a video web-based platform) is gaining increased attention. However, there is skepticism about its acceptance, safety, and efficacy for patients with high emotional and behavioral dysregulation. Objective: This study aims to provide initial effect size estimates of symptom change from pre- to post treatment, and the acceptance and safety of telehealth dialectical behavior therapy (DBT) for individuals diagnosed with borderline personality disorder (BPD). Methods: A total of 39 individuals meeting the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders [Fifth Edition]) criteria for BPD received 1 year of outpatient telehealth DBT at 3 sites in Germany and Canada. Effect size estimates were assessed using pre-post measures of BPD symptoms, dissociation, and quality of life. Safety was evaluated by analyzing suicide attempts and self-harm. Additionally, acceptance and feasibility, satisfaction with treatment, useability of the telehealth format, and the quality of the therapeutic alliance were assessed from both therapists’ and patients’ perspectives. All analyses were conducted on both the intention-to-treat (ITT) and according-to-protocol (ATP) samples. Results: Analyses showed significant and large pre-post effect sizes for BPD symptoms (d=1.13 in the ITT sample and d=1.44 in the ATP sample; P<.001) and for quality of life (d=0.65 in the ITT sample and d=1.24 in the ATP sample). Dissociative symptoms showed small to nonsignificant reductions. Self-harm behaviors decreased significantly from 80% to 28% of all patients showing at least 1 self-harm behavior in the last 10 weeks (risk ratio 0.35). A high dropout rate of 38% was observed. One low-lethality suicide attempt was reported. Acceptance, feasibility, and satisfaction measures were high, although therapists reported only moderate useability of the telehealth format. Conclusions: Telehealth DBT for BPD showed large pre-post effect sizes for BPD symptoms and quality of life. While the telehealth format appeared feasible and well-accepted, the dropout rate was relatively high. Future research should compare the efficacy of telehealth DBT with in-person formats in randomized controlled trials. Overall, telehealth DBT might offer a potentially effective alternative treatment option, enhancing treatment accessibility. However, strategies for decreasing drop-out should be considered. Trial Registration: German Clinical Trials Register DRKS00027824; https://drks.de/search/en/trial/DRKS00027824 %M 39808784 %R 10.2196/66181 %U https://formative.jmir.org/2025/1/e66181 %U https://doi.org/10.2196/66181 %U http://www.ncbi.nlm.nih.gov/pubmed/39808784 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e37083 %T Eliciting Preferences for the Uptake of Smoking Cessation Apps: Discrete Choice Experiment %A Szinay,Dorothy %A Cameron,Rory A %A Jones,Andy %A Whitty,Jennifer A %A Chadborn,Tim %A Brown,Jamie %A Naughton,Felix %+ Behavioural and Implementation Science Group, School of Health Sciences, University of East Anglia, Research Park, Norwich, NR4 7TJ, United Kingdom, 44 01603456161, dorothy.szinay@uea.ac.uk %K discrete choice experiment %K uptake, engagement %K mHealth %K smartphone app %K smoking cessation %K health app %K behavior change %K TDF %K theoretical domains framework %K mobile phone %D 2025 %7 14.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: If the most evidence-based and effective smoking cessation apps are not selected by smokers wanting to quit, their potential to support cessation is limited. Objective: This study sought to determine the attributes that influence smoking cessation app uptake and understand their relative importance to support future efforts to present evidence-based apps more effectively to maximize uptake. Methods: Adult smokers from the United Kingdom were invited to participate in a discrete choice experiment. Participants made 12 choices between two hypothetical smoking cessation app alternatives, with five predefined attributes reflecting domains from the theoretical domains framework: (1) monthly price of the app (environmental resources), (2) credible source as app developer (social influence), (3) social proof as star rating (social influence), (4) app description type (beliefs about consequences), and (5) images shown (beliefs about consequences); or opting out (choosing neither app). Preferences and the relative importance of attributes were estimated using mixed logit modeling. Willingness to pay and predicted uptake of the most and least preferred app were also calculated. Results: A total of 337 adult smokers completed the survey (n=168, 49.8% female; mean age 35, SD 11 years). Participants selected a smoking cessation app rather than opting out for 90% of the choices. Relative to other attributes, a 4.8-star user rating, representing social proof, was the strongest driver of app selection (mean preference parameter 2.27, SD 1.55; 95% CI 1.95-2.59). Participants preferred an app developed by health care–orientated trusted organization (credible source) over a hypothetical company (mean preference parameter 0.93, SD 1.23; 95% CI 0.72-1.15), with a logo and screenshots over logo only (mean preference parameter 0.39, SD 0.96; 95% CI 0.19-0.59), and with a lower monthly cost (mean preference parameter –0.38, SD 0.33; 95% CI –0.44 to –0.32). App description did not influence preferences. The uptake estimate for the best hypothetical app was 93% and for the worst, 3%. Participants were willing to pay a single payment of up to an additional US $6.96 (UK £5.49) for 4.8-star ratings, US $3.58 (UK £2.82) for 4-star ratings, and US $2.61(UK £2.06) for an app developed by a trusted organization. Conclusions: On average, social proof appeared to be the most influential factor in app uptake, followed by credible source, one perceived as most likely to provide evidence-based apps. These attributes may support the selection of evidence-based apps. %M 39808479 %R 10.2196/37083 %U https://www.jmir.org/2025/1/e37083 %U https://doi.org/10.2196/37083 %U http://www.ncbi.nlm.nih.gov/pubmed/39808479 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e59871 %T Effectiveness of the User-Centered “Healthcare CEO” App for Patients With Type 1 Diabetes Transitioning From Adolescence to Early Adulthood: Protocol for a Randomized Controlled Trial %A Chiang,Yueh-Tao %A Yu,Hsing-Yi %A Tsay,Pei-Kwei %A Chen,Chi-Wen %A Chang,Chi-Wen %A Hsu,Chien-Lung %A Lo,Fu-Sung %A Moons,Philip %+ School of Nursing, College of Medicine, Chang-Gung University, No.259, Wenhua 1st Rd, Guishan Dist., City , Taiwan (R.O.C.), Taoyuan, 33302, Taiwan, 886 32118800 ext 3866, lisachiang@mail.cgu.edu.tw %K type 1 diabetes %K transition %K mobile health %K treatment fidelity %K diabetes %K user-centered %K adolescence %K teenager %K app %K adolescent patients %K early adulthood %D 2025 %7 13.1.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Young patients aged 16 to 25 years with type 1 diabetes (T1D) often encounter challenges related to deteriorating disease control and accelerated complications. Mobile apps have shown promise in enhancing self-care among youth with diabetes. However, inconsistent findings suggest that further evidence is necessary to confirm the effectiveness of app-based interventions. Objective: This study aims to evaluate the effectiveness of the Healthcare CEO app in patients with T1D transitioning from adolescence to early adulthood. Methods: A 2 arms, double-blind, randomized controlled trial will be conducted over a 9-month period, with strategies designed to enhance treatment fidelity. The study expects to enroll 96 patients with T1D, aged 16 to 25 years. Participants will be randomly assigned to either the experimental or control group through central randomization. The intervention will be implemented using the Healthcare CEO app, which consists of 11 interfaces. The research will compare differences in disease control outcomes, confidence in self-management, self-care behaviors, emotional distress, quality of life, and specific diabetes-related knowledge between the 2 groups at baseline and 3, 6, and 9 months after intervention. Additionally, changes within the experimental group will be analyzed before and after the intervention. Results: The study was funded in August 2020. It was originally scheduled from August 2020 to July 2022 but was interrupted by the COVID-19 pandemic after enrolling 38 participants, with preliminary results anticipated for publication by November 2024. Recruitment resumed in August 2023, with findings expected to be finalized by July 2025. Conclusions: The Healthcare CEO app is a comprehensive solution tailored specifically for individuals with T1D transitioning from adolescence to early adulthood. This innovative app has the potential to improve the quality of care for adolescents with T1D during this critical stage and may serve as valuable evidence in support of app-based intervention strategies. Trial Registration: ClinicalTrials.gov NCT05022875; https://www.clinicaltrials.gov/study/NCT05022875 International Registered Report Identifier (IRRID): DERR1-10.2196/59871 %M 39805107 %R 10.2196/59871 %U https://www.researchprotocols.org/2025/1/e59871 %U https://doi.org/10.2196/59871 %U http://www.ncbi.nlm.nih.gov/pubmed/39805107 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e57363 %T Enhancing HIV Cognitive Abilities and Self-Management Through Information Technology–Assisted Interventions: Scoping Review %A Huang,Hao %A Xie,MeiLian %A Yang,Zhen %A Wang,AiPing %+ First Hospital of China Medical University, The First Affiliated Hospital of China Medical University, No.155, Nanjing North Street, Heping District, Shenyang, 110001, China, 86 1399889 0800, apwang@cmu.edu.cn %K digital media %K self-management %K HIV %K AIDS %K scoping review %K technology-assisted interventions %K information technology %K behaviors %K patient %K electronic database %K information systems %K smartphone %K app %K SMS text messaging %K effectiveness %K mobile phone %D 2025 %7 13.1.2025 %9 Review %J J Med Internet Res %G English %X Background: HIV/AIDS remains a significant global challenge, and with the rapid advancement of technology, there has been an increasing number of interventions aimed at improving HIV/AIDS cognition and self-management behaviors among patients. However, there is still a lack of detailed literature integrating relevant evidence. Objective: This study aims to comprehensively review existing research on interventions using modern information methods to improve HIV/AIDS cognition and enhance self-management behaviors among patients. It systematically reports the theoretical frameworks and specific intervention strategies used in current research, providing a comprehensive overview of the development status of relevant studies. We aim to compile existing evidence through this scoping review to identify potential avenues for future research. Methods: We followed the scoping review framework proposed by the Joanna Briggs Institute for the synthesis and reporting of evidence. Relevant literature was searched using electronic databases, including PubMed, Web of Science, Embase, CINAHL, and Cochrane Library. The time frame for inclusion was from 2018 to December 1, 2023. Inclusion criteria were (1) interventions using modern information technology or new digital media, (2) studies focusing on improving HIV awareness or self-management behaviors among people living with HIV, (3) intervention studies or evaluations of intervention effects, and (4) studies published within the last five years. Two reviewers (HH and MX) independently assessed each study at both the title and abstract screening stage and the full-text review stage, resolving any disagreements through discussion. Results: A total of 55 studies that met the inclusion criteria were included. The Information-Motivation-Behavioral Skills model, Social Cognitive Theory, Health Belief Model, Theory of Planned Behavior, and Information Systems Research Framework are among the most commonly used theoretical frameworks. Modern information technology interventions are mainly constructed using smartphone apps, SMS text messaging, internet-based platforms, audiovisual materials, and digital health education platforms, with smartphone apps and SMS text messaging being the most widely used intervention media. Conclusions: Modern information technology is becoming an important tool for health interventions among people living with HIV/AIDS. However, future research should focus on integrating theoretical framework guidance with intervention design, further exploring the diversity of intervention implementations, the applicability of different technological methods, their long-term effects, and how to more effectively combine traditional intervention strategies to maximize intervention outcomes. %M 39805101 %R 10.2196/57363 %U https://www.jmir.org/2025/1/e57363 %U https://doi.org/10.2196/57363 %U http://www.ncbi.nlm.nih.gov/pubmed/39805101 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e67554 %T Effectiveness and Safety of the TRIO Optimal Health Management Program in Patients With Type 2 Diabetes Mellitus Initiating Basal Insulin Therapy: Prospective Observational Real-World Study %A Li,Chenxi %A Guo,Lixin %A Shi,Lixin %A Chen,Li %A Chen,Liming %A Xue,Yaoming %A Li,Hong %A Liang,Yuzhen %A Yang,Jing %A Wang,Weimin %A Zhu,Dalong %+ Department of Endocrinology, Endocrine and Metabolic Disease Medical Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing Medical School, 321 Zhongshan Road, Nanjing, 210095, China, 86 13805150781, zhudalong@nju.edu.cn %K type 2 diabetes %K TRIO optimal health management program %K initiating basal insulin therapy %K glycemic control %K real-world study %D 2025 %7 13.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Diabetes, a chronic disease necessitating long-term treatment and self-management, presents significant challenges for patients who spend most of their treatment time outside of hospitals. The potential of digital therapeutics for diabetes has garnered recognition from different organizations. Although some prior studies have demonstrated successful reductions in patients’ blood glucose levels and body weight through digital diabetes programs, many studies were limited by including patients with prediabetes, including patients treated with mostly premixed insulin, or evaluating user engagement outcomes rather than clinical outcomes. Consequently, limited evidence remains regarding the effectiveness of health management mobile apps specifically designed for patients with type 2 diabetes mellitus (T2DM) initiating basal insulin (BI). Based on this, a data-based and artificial intelligence management system named “TRIO” was developed to provide patients with more personalized intervention methods in stages, in groups, and around the clock. TRIO assists doctors and nurses in achieving better blood glucose controls, truly carries out standardized management around patients, and allows them to have a higher quality of life. TRIO represents the 3 essential pillars in comprehensive diabetes management: physician, nurse, and patient. Objective: This prospective observational study evaluated the effectiveness and safety of the TRIO optimal health management program for patients with T2DM initiating BI therapy in a real-world setting. Methods: Patients aged 18-85 years with inadequate glycemic control (baseline hemoglobin A1c [HbA1c] ≥7%) starting BI therapy were enrolled in outpatient and inpatient settings. The study lasted 3 months, with health education and phone-based follow-up assessments. Data collected included patient characteristics, medical history, baseline diabetes conditions, treatment compliance, glycemic control, and safety indicators. Results: A total of 199,431 patients were included, and 118,134 patients completed the 3-month follow-up between December 1, 2019, and December 31, 2021, involving 574 hospitals in China. The mean baseline HbA1c was 9.2%, the mean duration of diabetes was 7.3 years, and 80.4% (1,59,930/1,98,969) of patients were using BI with oral antihyperglycemic drugs. After the intervention, mean HbA1c decreased by –2.59% from baseline, with 55.6% (28,858/51,912) achieving the target HbA1c level of <7%. Patients who set lower fasting plasma glucose goals (<6.1 mmol/L) showed more significant HbA1c reductions (P<.001) and higher target achievement than those with fasting plasma glucose goals of ≥6.1 mmol/L. Factors such as complications, diabetes duration, and baseline HbA1c levels influenced the magnitude of HbA1c reduction. The presence of complications, shorter diabetes duration, and higher baseline HbA1c were significantly associated with increased hypoglycemia incidence risk (all P<.05). Conclusions: The TRIO optimal health management program effectively improved glycemic control in patients with T2DM initiating BI therapy. Individualized treatment approaches considering patient characteristics and glycemic goals are vital for optimal outcomes. %M 39694849 %R 10.2196/67554 %U https://www.jmir.org/2025/1/e67554 %U https://doi.org/10.2196/67554 %U http://www.ncbi.nlm.nih.gov/pubmed/39694849 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e57619 %T Studying the Digital Intervention Engagement–Mediated Relationship Between Intrapersonal Measures and Pre-Exposure Prophylaxis Adherence in Sexual and Gender Minority Youth: Secondary Analysis of a Randomized Controlled Trial %A Williams,Michael P %A Manjourides,Justin %A Smith,Louisa H %A Rainer,Crissi B %A Hightow-Weidman,Lisa B %A Haley,Danielle F %+ Bouve College of Health Sciences, Northeastern University, 30 Leon St, Boston, MA, 02115, United States, 1 617 373 3323, mpw144@gmail.com %K engagement %K pre-exposure prophylaxis %K PrEP %K digital health intervention %K adherence %K men who have sex with men %K sexual orientation %K gender minority %K youth %K adolescent %K teenager %K HIV %K randomized controlled trial %K mental health %K sociodemographic %K logistic regression %K health information %K health behavior %K sexual health %D 2025 %7 13.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Improving adherence to pre-exposure prophylaxis (PrEP) via digital health interventions (DHIs) for young sexual and gender minority men who have sex with men (YSGMMSM) is promising for reducing the HIV burden. Measuring and achieving effective engagement (sufficient to solicit PrEP adherence) in YSGMMSM is challenging. Objective: This study is a secondary analysis of the primary efficacy randomized controlled trial (RCT) of Prepared, Protected, Empowered (P3), a digital PrEP adherence intervention that used causal mediation to quantify whether and to what extent intrapersonal behavioral, mental health, and sociodemographic measures were related to effective engagement for PrEP adherence in YSGMMSM. Methods: In May 2019, 264 YSGMMSM were recruited for the primary RCT via social media, community sites, and clinics from 9 study sites across the United States. For this secondary analysis, 140 participants were eligible (retained at follow-up, received DHI condition in primary RCT, and completed trial data). Participants earned US currency for daily use of P3 and lost US currency for nonuse. Dollars accrued at the 3-month follow-up were used to measure engagement. PrEP nonadherence was defined as blood serum concentrations of tenofovir-diphosphate and emtricitabine-triphosphate that correlated with ≤4 doses weekly at the 3-month follow-up. Logistic regression was used to estimate the total effect of baseline intrapersonal measures on PrEP nonadherence, represented as odds ratios (ORs) with a null value of 1. The total OR for each intrapersonal measure was decomposed into direct and indirect effects. Results: For every US $1 earned above the mean (US $96, SD US $35.1), participants had 2% (OR 0.98, 95% CI 0.97-0.99) lower odds of PrEP nonadherence. Frequently using phone apps to track health information was associated with a 71% (OR 0.29, 95% CI 0.06-0.96) lower odds of PrEP nonadherence. This was overwhelmingly a direct effect, not mediated by engagement, with a percentage mediated (PM) of 1%. Non-Hispanic White participants had 83% lower odds of PrEP nonadherence (OR 0.17, 95% CI 0.05-0.48) and had a direct effect (PM=4%). Participants with depressive symptoms and anxiety symptoms had 3.4 (OR 3.42, 95% CI 0.95-12) and 3.5 (OR 3.51, 95% CI 1.06-11.55) times higher odds of PrEP nonadherence, respectively. Anxious symptoms largely operated through P3 engagement (PM=51%). Conclusions: P3 engagement (dollars accrued) was strongly related to lower odds of PrEP nonadherence. Intrapersonal measures operating through P3 engagement (indirect effect, eg, anxious symptoms) suggest possible pathways to improve PrEP adherence DHI efficacy in YSGMMSM via effective engagement. Conversely, the direct effects observed in this study may reflect existing structural disparity (eg, race and ethnicity) or behavioral dispositions toward technology (eg, tracking health via phone apps). Evaluating effective engagement in DHIs with causal mediation approaches provides a clarifying and mechanistic view of how DHIs impact health behavior. Trial Registration: ClinicalTrials.gov; NCT03320512; https://clinicaltrials.gov/study/NCT03320512 %M 39804696 %R 10.2196/57619 %U https://www.jmir.org/2025/1/e57619 %U https://doi.org/10.2196/57619 %U http://www.ncbi.nlm.nih.gov/pubmed/39804696 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e59027 %T Mapping the Landscape of Digital Health Intervention Strategies: 25-Year Synthesis %A Liu,Shiyu %A Ma,Jingru %A Sun,Meichen %A Zhang,Chao %A Gao,Yujing %A Xu,Jinghong %+ , School of Journalism and Communication, Beijing Normal University, No 19, Xinjiekouwai St, Haidian District, Beijing, China, Beijing, 100875, China, 86 15810320711, 123abctg@163.com %K digital health interventions %K intervention strategies %K behavior change %K mHealth %K eHealth %K randomized controlled trial %D 2025 %7 13.1.2025 %9 Review %J J Med Internet Res %G English %X Background: Digital health interventions have emerged as promising tools to promote health behavior change and improve health outcomes. However, a comprehensive synthesis of strategies contributing to these interventions is lacking. Objective: This study aims to (1) identify and categorize the strategies used in digital health interventions over the past 25 years; (2) explore the differences and changes in these strategies across time periods, countries, populations, delivery methods, and senders; and (3) serve as a valuable reference for future researchers and practitioners to improve the effectiveness of digital health interventions. Methods: This study followed a systematic review approach, complemented by close reading and text coding. A comprehensive search for published English academic papers from PubMed, Web of Science, and Scopus was conducted. The search employed a combination of digital health and intervention-related terms, along with database-specific subject headings and filters. The time span covered 25 years, from January 1, 1999, to March 10, 2024. Sample papers were selected based on study design, intervention details, and strategies. The strategies were identified and categorized based on the principles of Behavior Change Techniques and Behavior Strategies. Results: A total of 885 papers involving 954,847 participants met the eligibility criteria. We identified 173 unique strategies used in digital health interventions, categorized into 19 themes. The 3 most frequently used strategies in the sample papers were “guide” (n=492, 55.6%), “monitor” (n=490, 55.4%), and “communication” (n=392, 44.3%). The number of strategies employed in each paper ranged from 1 to 32. Most interventions targeted clients (n=844, 95.4%) and were carried out in hospitals (n=268, 30.3%). High-income countries demonstrated a substantially higher number and diversity of identified strategies than low- and middle-income countries, and the number of studies targeting the public (n=647, 73.1%) far exceeded those focusing on vulnerable groups (n=238, 26.9%). Conclusions: Digital health interventions and strategies have undergone considerable development over the past 25 years. They have evolved from simple approaches to sophisticated, personalized techniques and are trending toward multifaceted interventions, leveraging advanced technologies for real-time monitoring and feedback. Future studies should focus on rigorous evaluations, long-term effectiveness, and tailored approaches for diverse populations, and more attention should be given to vulnerable groups. %M 39804697 %R 10.2196/59027 %U https://www.jmir.org/2025/1/e59027 %U https://doi.org/10.2196/59027 %U http://www.ncbi.nlm.nih.gov/pubmed/39804697 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 11 %N %P e59478 %T A Novel Telehealth Exercise Program Designed for Rural Survivors of Cancer With Cancer-Related Fatigue: Single-Arm Feasibility Trial %A Marker,Ryan J %A Kittelson,Andrew J %A Scorsone,Jared J %A Moran,Ian A %A Quindry,John C %A Leach,Heather J %+ Department of Physical Medicine and Rehabilitation, University of Colorado Anschutz Medical Campus, 12348 E Montview Boulevard, Aurora, CO, 80045, United States, 1 13037240819, ryan.marker@cuanschutz.edu %K cancer-related fatigue %K telehealth %K physical activity %K survivorship %K digital health %K lifestyle intervention %K videoconference %K symptom burden %K symptom monitoring %K geographic disparities %K mHealth %D 2025 %7 10.1.2025 %9 Original Paper %J JMIR Cancer %G English %X Background: Exercise interventions are among the best-known interventions for cancer-related fatigue (CRF). Rural survivors of cancer, however, report specific barriers to engaging in exercise programs and lack overall access to effective programs. Objective: The purpose of this investigation was to assess the feasibility of a novel telehealth exercise program designed specifically for rural survivors of cancer with CRF. Methods: A single-arm clinical trial of the BfitBwell Telehealth Program was performed. Based on an established clinical program, this adapted 12-week program addressed barriers previously reported by rural survivors by providing synchronous videoconference exercise sessions (2 per program), asynchronous exercise sessions using a personal training smartphone or internet app (3-5 per week), and regular symptom (CRF) monitoring using automated emailed surveys (every 2 weeks). Personalized exercise prescriptions containing aerobic and resistance activities were implemented by cancer exercise specialists. Symptom-triggered synchronous sessions were initiated for participants failing to improve in CRF, as identified by a reference chart of CRF improvements observed during a supervised exercise program. Eligible participants were adult survivors of any cancer diagnosis who had completed treatment with curative intent in the past 12 months or had no planned changes in treatment for the duration of the study, lived in a rural area, and were currently experiencing CRF. Feasibility was assessed by objective measures of recruitment, data collection, intervention acceptability and suitability, and preliminary evaluations of participant responses. CRF was the primary clinical outcome (assessed using the Functional Assessment of Chronic Illness Therapy—Fatigue Scale [FACIT-Fatigue]) and was measured before, after, and 6 months after program completion. Results: In total, 19 participants enrolled in the study, 16 initiated the exercise program, and 15 completed the program. A total of 14 participants were recruited through internet advertisements, and the total recruitment rate peaked at 5 participants per month. Participants completed 100% of initial and final assessments (30 assessments across all participants) and 93% (70/75 possible surveys across all participants) of emailed surveys and attended 97% (29/30 possible sessions across all participants) of synchronous exercise sessions. In total, 6 participants initiated symptom-triggered sessions, with 6 of 7 initiated sessions attended. The mean FACIT-Fatigue scores significantly improved (P=.001) by 11.2 (SD 6.8) points following the completion of the program. A total of 13 participants demonstrated at least a minimal clinically important difference in FACIT-Fatigue scores (≥ +3 points) at this time. FACIT-Fatigue scores did not significantly change from program completion to 6-month follow-up (n=13; mean change –1.1, SD 3.4 points; P=.29). Conclusions: Results from this investigation support the feasibility of the BfitBwell Telehealth Program and a subsequent efficacy trial. Novel program components also provide potential models for improving exercise program efficacy and efficiency through asynchronous exercise prescription and symptom monitoring. Trial Registration: ClinicalTrials.gov NCT04533165; https://clinicaltrials.gov/study/NCT04533165 %M 39793972 %R 10.2196/59478 %U https://cancer.jmir.org/2025/1/e59478 %U https://doi.org/10.2196/59478 %U http://www.ncbi.nlm.nih.gov/pubmed/39793972 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 10 %N %P e67636 %T “Now I can see it works!” Perspectives on Using a Nutrition-Focused Approach When Initiating Continuous Glucose Monitoring in People with Type 2 Diabetes: Qualitative Interview Study %A Willis,Holly J %A Henderson,Maren S G %A Zibley,Laura J %A JaKa,Meghan M %+ International Diabetes Center, HealthPartners Institute, 3800 Park Nicollet Blvd, Minneapolis, MN, 55416, United States, 1 9529933219, holly.willis@parknicollet.com %K diabetic %K diabetes mellitus %K DM %K type 2 diabetes %K T2D %K endocrinology %K nutrition %K diet %K continuous glucose monitoring %K glucose monitor %K glucose %K glycemic control %K time in range %K self-care %K education %K mHealth %D 2025 %7 10.1.2025 %9 Original Paper %J JMIR Diabetes %G English %X Background: Food choices play a significant role in achieving glycemic goals and optimizing overall health for people with type 2 diabetes (T2D). Continuous glucose monitoring (CGM) can provide a comprehensive look at the impact of foods and other behaviors on glucose in real time and over the course of time. The impact of using a nutrition-focused approach (NFA) when initiating CGM in people with T2D is unknown. Objective: This study aims to understand the perspectives and behaviors of people with T2D who participated in an NFA during CGM initiation. Methods: Semistructured qualitative interviews were conducted with UNITE (Using Nutrition to Improve Time in Range) study participants. UNITE was a 2-session intervention designed to introduce and initiate CGM using an NFA in people with T2D who do not use insulin. The intervention included CGM initiation materials that emphasized the continuous glucose monitor as a tool to guide evidence-based food choices. The materials were designed to support conversation between the CGM user and diabetes care provider conducting the sessions. A rapid matrix analysis approach was designed to answer two main questions: (1) How do people who participate in an NFA during CGM initiation describe this experience? and (2) How do people who participate in an NFA during CGM initiation use CGM data to make food-related decisions, and what food-related changes do they make? Results: Overall, 15 people completed interviews after completion of the UNITE study intervention: 87% (n=13) identified as White, 60% (n=9) identified as male, mean age of 64 (SD 7.4) years, mean T2D duration of 7.5 (SD 3.8) years, and mean hemoglobin A1c level of 7.5% (SD 0.4%). Participants fluently discussed glycemic metrics such as time in range (percent time with glucose 70-180 mg/dL) and reported regularly using real-time and retrospective CGM data. Participants liked the simplicity of the intervention materials (eg, images and messaging), which demonstrated how to use CGM data to learn the glycemic impact of food choices and suggested how to adjust food choices for improved glycemia. Participants reported that CGM data impacted how they thought about food, and most participants made changes because of seeing these data. Many of the reported changes aligned with evidence-based guidance for a healthy lifestyle, including prioritizing nonstarchy vegetables, reducing foods with added sugar, or walking more; however, some people reported behavior changes, such as skipping or delaying meals to stay in the target glucose range. A few participants reported that the CGM amplified negative feelings about food or eating. Conclusions: Participants agreed that pairing nutrition information with CGM initiation instructions was helpful for their diabetes care. In general, the NFA during CGM initiation was well received and led to positive changes in food choices and behaviors during a 2-month intervention. %M 39793006 %R 10.2196/67636 %U https://diabetes.jmir.org/2025/1/e67636 %U https://doi.org/10.2196/67636 %U http://www.ncbi.nlm.nih.gov/pubmed/39793006 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e67627 %T Trends in Mental Health Outcomes of College Students Amid the Pandemic (Roadmap mHealth App): Longitudinal Observational Study %A Jayaraj,Gautham %A Cao,Xiao %A Horwitz,Adam %A Rozwadowski,Michelle %A Shea,Skyla %A Hanauer,Shira N %A Hanauer,David A %A Tewari,Muneesh %A Shedden,Kerby %A Choi,Sung Won %+ Department of Pediatrics, Medical School, University of Michigan, 1200 E Hospital Dr, Medical Professional Building D4115, Ann Arbor, MI, 48109, United States, 1 734 615 5707, sungchoi@med.umich.edu %K mHealth %K college %K student %K mental health %K positive psychology %K flourishing %K COVID-19 %K wellbeing %K mobile phone %K SARS-CoV-2 %K coronavirus %K pandemic %K COVID %K app %K digital health %K smartphone %K eHealth %K telehealth %K telemedicine %K longitudinal %K higher education %K depression %K anxiety %K loneliness %D 2025 %7 9.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: The mental health crisis among college students intensified amid the COVID-19 pandemic, suggesting an urgent need for innovative solutions to support them. Previous efforts to address mental health concerns have been constrained, often due to the underuse or shortage of services. Mobile health (mHealth) technology holds significant potential for providing resilience-building support and enhancing access to mental health care. Objective: This study aimed to examine the trends in mental health and well-being outcomes over 3 years among college students, with an exploratory aim to assess the potential impact of the Roadmap mHealth app on these outcomes. Methods: A fully automated longitudinal observational study was conducted remotely from a large public academic institution in the Midwestern United States, evaluating mental health and well-being outcomes among college students using the Roadmap mHealth app over 3 fall semesters from 2020 to 2022. The study enrolled 2164 college students in Year I, with 1128 and 1033 students returning in Years II and III, respectively. Participants completed various self-reported measures, including the Patient Health Questionnaire-9 for depression, Generalized Anxiety Disorder-7 for anxiety, and additional metrics for coping, flourishing, and loneliness. Results: The findings indicated an evolving trajectory in students’ mental health. In Year I, depression and anxiety levels were higher compared with levels reported between 2014 and 2019, remaining stable into Year II. However, significant decreases were noted by Year III for both depression (Year I mean 7.78, SD 5.65 vs Year III mean 6.21, SD 4.68; t108=–2.90; P=.01) and anxiety (Year I mean 6.61, SD 4.91 vs Year III mean 5.62, SD 4.58; t116=–2.02; P=.046). Problem-focused coping decreased initially from Year I (mean 2.46, SD 0.58) to Year II (mean 2.36, SD 0.60; t1073=–5.87; P<.001), then increased by Year III (mean 2.40, SD 0.63; t706=2.26; P=.02). Emotion-focused (Year I mean 2.33, SD 0.41 vs Year III mean 2.22, SD 0.47; t994=–7.47; P<.001) and avoidant coping (Year I mean 1.76, SD 0.37 vs Year III mean 1.65, SD 0.38; t997=–8.53; P=.02) consistently decreased. Loneliness significantly decreased from Year I (mean 5.79, SD 1.74) to Year III (mean 5.17, SD 1.78; t1013=–10.74; P<.001), accompanied by an increase in flourishing from Year I (mean 63.78, SD 14.76) to Year III (mean 66.98, SD 15.06; t994=7.22; P<.001). Analysis of app usage indicated that the positive piggy bank and gratitude journal were the favored activities. Greater engagement with the app was positively correlated with enhanced flourishing, even after adjusting for demographic and sociobehavioral factors (β=.04, SE .016; t3974=2.17; P=.03). Conclusions: In this study, students’ mental health and well-being improved, with notable reductions in depression, anxiety, and loneliness, associated with an increase in flourishing. The app did not appear to worsen students’ mental health. Based on the usage pattern, it is possible the app enhanced positive psychology-based practices. Future research should explore the efficacy of mHealth interventions through randomized controlled trials to further understand their impact on college students’ mental health outcomes. Trial Registration: ClinicalTrials.gov NCT04766788; https://clinicaltrials.gov/ct2/show/NCT04766788 International Registered Report Identifier (IRRID): RR2-10.2196/29561 %M 39787592 %R 10.2196/67627 %U https://www.jmir.org/2025/1/e67627 %U https://doi.org/10.2196/67627 %U http://www.ncbi.nlm.nih.gov/pubmed/39787592 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e68072 %T Assessing the Effectiveness of Interactive Robot-Assisted Virtual Health Coaching for Health Literacy and Disease Knowledge of Patients with Chronic Kidney Disease: Quasiexperimental Study %A Chen,Nai-Jung %A Chang,Ching-Hao %A Huang,Chiu-Mieh %A Lin,Fen-He %A Lu,Li-Ting %A Liu,Kuan-Yi %A Lai,Chih-Lin %A Lin,Chin-Yao %A Hou,Yi-Chou %A Guo,Jong-Long %+ Department of Health Promotion and Health Education, College of Education, National Taiwan Normal University, 162, Section 1, Heping E Rd, Da'an District, Taipei, 10610, Taiwan, 886 7749 1728, jonglong@ntnu.edu.tw %K chronic kidney disease %K disease knowledge %K eHealth %K health coaching %K health education %K health literacy %K interactive robot %D 2025 %7 9.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic kidney disease (CKD) imposes a significant global health and economic burden, impacting millions globally. Despite its high prevalence, public awareness and understanding of CKD remain limited, leading to delayed diagnosis and suboptimal management. Traditional patient education methods, such as 1-on-1 verbal instruction or printed brochures, are often insufficient, especially considering the shortage of nursing staff. Technology-assisted education presents a promising and standardized solution, emphasizing the need for innovative and scalable approaches to improve CKD-specific knowledge and health literacy. Objective: This study aimed to develop and evaluate the effectiveness of an innovative 12-unit virtual health coaching program delivered through interactive robots that is intended to enhance disease knowledge and health literacy among patients with CKD. Methods: A quasiexperimental design was used, and 60 participants were evenly assigned to experimental and comparison groups. However, due to attrition, 14 participants in the experimental group and 16 participants in the comparison group completed the study. The intervention involved a 12-unit program, with each unit lasting approximately 20 minutes to 30 minutes and delivered across 3 to 4 learning sessions, and participants completed 3 to 4 units per session. The program addressed key aspects of CKD-specific health literacy including functional, communicative, and critical literacy and CKD-specific knowledge including basic knowledge, prevention, lifestyle, dietary intake, and medication. Data were collected through validated pre and postintervention questionnaires. All 30 participants completed the program and subsequent evaluations, with outcome measures assessing changes in CKD-specific knowledge and health literacy. Results: Postintervention analysis using generalized estimating equations, adjusted for age, revealed that the experimental group (n=14) had significantly greater improvements in health literacy (coefficient=2.51, Wald χ²1=5.89; P=.02) and disease knowledge (coefficient=1.66, Wald χ²1=11.75; P=.001) than the comparison group (n=16). Postintervention t tests revealed significant improvements in CKD-specific health literacy and disease knowledge (P<.001) between the experimental and comparison groups. Additional analyses identified significant group × time interactions, indicating improvements in communicative literacy (P=.01) and critical literacy (P=.02), while no significant changes were observed in functional literacy. Regarding disease knowledge, the experimental group demonstrated a significant improvement in medication (P<.001), whereas changes in basic knowledge, prevention, lifestyle, and dietary intake were not significant. Conclusions: This study demonstrated that interactive robot-assisted eHealth coaching effectively enhanced CKD-specific disease knowledge and health literacy. Despite the challenges posed by the COVID-19 pandemic, which constrained sample sizes, the findings indicate that this program is a promising patient education tool in clinical nephrology. Future research should involve larger sample sizes to enhance generalizability and examine additional factors influencing effectiveness. %M 39787589 %R 10.2196/68072 %U https://www.jmir.org/2025/1/e68072 %U https://doi.org/10.2196/68072 %U http://www.ncbi.nlm.nih.gov/pubmed/39787589 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 9 %N %P e65981 %T Efficacy of Unsupervised YouTube Dance Exercise for Patients With Hypertension: Randomized Controlled Trial %A Sakairi,Mizuki %A Miyagami,Taiju %A Tabata,Hiroki %A Yanagisawa,Naotake %A Saita,Mizue %A Suzuki,Mai %A Fujibayashi,Kazutoshi %A Fukuda,Hiroshi %A Naito,Toshio %+ Department of General Medicine, Faculty of Medicine, Juntendo University, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan, 81 338133111, tmiyaga@juntendo.ac.jp %K dance %K video %K exercise therapy %K hypertension %K blood pressure therapy %K YouTube %K mHealth %D 2025 %7 9.1.2025 %9 Original Paper %J JMIR Cardio %G English %X Background: High blood pressure (BP) is linked to unhealthy lifestyles, and its treatment includes medications and exercise therapy. Many previous studies have evaluated the effects of exercise on BP improvement; however, exercise requires securing a location, time, and staff, which can be challenging in clinical settings. The antihypertensive effects of dance exercise for patients with hypertension have already been verified, and it has been found that adherence and dropout rates are better compared to other forms of exercise. If the burden of providing dance instruction is reduced, dance exercise will become a highly useful intervention for hypertension treatment. Objective: This study aims to investigate the effects of regular exercise therapy using dance videos on the BP of patients with hypertension, with the goal of providing a reference for prescribing exercise therapy that is highly feasible in clinical settings. Methods: This nonblind, double-arm, randomized controlled trial was conducted at Juntendo University, Tokyo, from April to December 2023. A total of 40 patients with hypertension were randomly assigned to either an intervention group (dance) or a control group (self-selected exercise), with each group comprising 20 participants. The intervention group performed daily dance exercises using street dance videos (10 min per video) uploaded to YouTube. The control group was instructed to choose any exercise other than dance and perform it for 10 minutes each day. The activity levels of the participants were monitored using a triaxial accelerometer. BP and body composition were measured on the day of participation and after 2 months. During the intervention period, we did not provide exercise instruction or supervise participants’ activities. Results: A total of 34 patients were included in the study (16 in the intervention group and 18 in the control group). The exclusion criteria were the absence of BP data, medication changes, or withdrawal from the study. The mean age was 56 (SD 9.8) years, and 18 (53%) of the patients were female. The mean BMI was 28.0 (SD 6.3) m/kg2, and systolic blood pressure (SBP) and diastolic blood pressure (DBP) were 139.5 (SD 17.1) mm Hg and 85.8 (SD 9.1) mm Hg, respectively. The basic characteristics did not differ between the two groups. In the multivariate analysis, SBP and DBP improved significantly in the intervention group compared to the control group (mean SBP –12.8, SD 6.1 mm Hg; P=.047; mean DBP –9.7, SD 3.3 mm Hg; P=.006). Conclusions: This study evaluated the effects of dance exercise on patients with hypertension, as previously verified, under the additional condition of using dance videos without direct staff instruction or supervision. The results showed that dance videos were more effective in lowering BP than conventional exercise prescriptions. Trial Registration: University Hospital Medical Information Network UMIN 000051251; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058446 %M 39787590 %R 10.2196/65981 %U https://cardio.jmir.org/2025/1/e65981 %U https://doi.org/10.2196/65981 %U http://www.ncbi.nlm.nih.gov/pubmed/39787590 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e59605 %T Effect of a Narrative-Based Online Course Aimed at Reducing Stigma Toward Transgender Children and Adolescents: Longitudinal Observational Study %A Greuel,Merlin %A Nguyen,Van Kinh %A Amsalem,Doron %A Adam,Maya %A Bärnighausen,Till %+ Heidelberg Institute of Global Health, Heidelberg University, Im Neuenheimer Feld 130/3, Heidelberg, 69120, Germany, 49 6221565344, greuel@stud.uni-heidelberg.de %K stigma %K transgender %K children %K adolescents %K mental health %K online course evaluation %K entertainment-education %K narratives %D 2025 %7 9.1.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Stigma toward transgender children and adolescents negatively impacts their health and educational outcomes. Contact with members of stigmatized groups can dismantle stereotypes and reduce stigma by facilitating exposure to the unique cognitive and emotional perspectives of individuals within the group. Recent evidence suggests that video-based contact interventions can be as effective as face-to-face encounters, but challenges lie in protecting the identities of transgender youth, since many of them live in stealth. Objective: This study aims to evaluate the impact of an animated online course, rooted in authentic, personal narratives, on course participants’ stigma toward transgender youth. Methods: The online course was offered free of charge on Coursera and contained 19 teaching videos (3-7 minutes each), intermittent practice quizzes, and discussion prompts. Using real voice recordings of transgender children and their caregivers, the videos were designed to elicit empathy and transmit knowledge. All videos conveying the narratives of transgender youth were animated to protect their identities. A total of 447 course participants, distributed around the globe, completed pre- and postcourse surveys. While the course primarily targeted parents and caregivers of transgender youth, it was open to anyone with a Coursera account. The survey was based on the Transgender Attitudes and Beliefs Scale but modified to reflect the context of parents and caregivers. Using a 5-point Likert scale, it contained 5 questions that captured participants’ levels of transgender stigma. Results of the pre- and postcourse surveys were then compared. Results: The results were obtained in January 2023. Baseline levels of stigma were relatively low (18/25 across all questions, with 25 representing the lowest possible levels of stigma) and decreased further after completion of the course (to 19/25 across all questions, P<.001). A multivariate ordinal probit regression showed that, depending on the question, participants were 7%-34% more likely to endorse statements that indicated the lowest levels of stigma after completing the course. The course was equally effective across all demographics represented in our participant population. Conclusions: Our findings document a significant reduction in stigma toward transgender youth in participants who chose to enroll in the first animated, open online gender health course, rooted in the authentic narratives of transgender youth. Stigma levels decreased significantly after taking the course, even among participants whose baseline levels of stigma were low. Future interventions should include participants with more variable baseline levels of stigma, ideally in the setting of a randomized controlled trial. Despite its limitations, this evaluation adds to the existing evidence that digital, contact-based antistigma interventions, animated to protect the identity of the narrators, can effectively reduce stigma toward transgender youth. %M 39786893 %R 10.2196/59605 %U https://formative.jmir.org/2025/1/e59605 %U https://doi.org/10.2196/59605 %U http://www.ncbi.nlm.nih.gov/pubmed/39786893 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e54524 %T Use of mHealth Technology for Improving Exercise Adherence in Patients With Heart Failure: Systematic Review %A Deka,Pallav %A Salahshurian,Erin %A Ng,Teresa %A Buchholz,Susan W %A Klompstra,Leonie %A Alonso,Windy %+ College of Nursing, Michigan State University, 1355 Bogue Street, C247, East Lansing, MI, 48824, United States, 1 5174328309, pdeka@msu.edu %K adherence %K activity monitors %K exercise %K heart failure %K mHealth %K mobile health %K smartphone %K videoconferencing %K heart %K mHealth technology %K exercise programs %K age %K sex %K race %K telehealth technology %K software apps %K feasibility %K mobile phone %D 2025 %7 9.1.2025 %9 Review %J J Med Internet Res %G English %X Background: The known and established benefits of exercise in patients with heart failure (HF) are often hampered by low exercise adherence. Mobile health (mHealth) technology provides opportunities to overcome barriers to exercise adherence in this population. Objective: This systematic review builds on prior research to (1) describe study characteristics of mHealth interventions for exercise adherence in HF including details of sample demographics, sample sizes, exercise programs, and theoretical frameworks; (2) summarize types of mHealth technology used to improve exercise adherence in patients with HF; (3) highlight how the term “adherence” was defined and how it was measured across mHealth studies and adherence achieved; and (4) highlight the effect of age, sex, race, New York Heart Association (NYHA) functional classification, and HF etiology (systolic vs diastolic) on exercise adherence. Methods: We searched for papers in PubMed, MEDLINE, and CINAHL databases and included studies published between January 1, 2015, and June 30, 2022. The risk of bias was analyzed. Results: In total, 8 studies (4 randomized controlled trials and 4 quasi-experimental trials) met our inclusion and exclusion criteria. A moderate to high risk of bias was noted in the studies. All studies included patients with HF in NYHA classification I-III, with sample sizes ranging from 12 to 81 and study durations lasting 4 to 26 weeks. Six studies had an equal distribution of male and female participants whose ages ranged between 53 and 73 years. Videoconferencing was used in 4 studies, while 4 studies used smartphone apps. Three studies using videoconferencing included an intervention that engaged participants in a group setting. A total of 1 study used a yoga program, 1 study used a walking program, 1 study combined jogging with walking, 1 study used a cycle ergometer, 2 studies combined walking with cycle ergometry, and 1 study used a stepper. Two studies incorporated resistance exercises in their program. Exercise programs varied, ranging between 3 and 5 days of exercise per week, with exercise sessions ranging from 30 to 60 minutes. The Borg rating of perceived exertion scale was mostly used to regulate exercise intensity, with 3 studies using heart rate monitoring using a Fitbit. Only 1 study implicitly mentions developing their intervention using a theoretical framework. Adherence was reported to the investigator-developed exercise programs. All studies were mostly feasibility or pilot studies, and the effect of age, sex, race, and NYHA classification on exercise adherence with the use of mHealth was not reported. Conclusions: The results show some preliminary evidence of the feasibility of using mHealth technology for building exercise adherence in patients with HF; however, theoretically sound and fully powered studies, including studies on minoritized communities, are lacking. In addition, the sustainability of adherence beyond the intervention period is unknown. %M 39786850 %R 10.2196/54524 %U https://www.jmir.org/2025/1/e54524 %U https://doi.org/10.2196/54524 %U http://www.ncbi.nlm.nih.gov/pubmed/39786850 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e63653 %T Satisfaction and Usability of a Commercially Available Medication Adherence App (Medisafe) Among Medically Underserved Patients With Chronic Illnesses: Survey Study %A Hartch,Christa %A Dietrich,Mary S %A Lancaster,B Jeanette %A Mulvaney,Shelagh A %A Stolldorf,Deonni P %+ School of Nursing and Health Sciences, Manhattanville University, 2900 Purchase Street, Purchase, NY, 10577, United States, 1 914 323 5365, christa.hartch@mville.edu %K medication adherence %K mHealth %K mobile phone %K app %K medically underserved %K chronic disease %K satisfaction %K usage %K health disparities %D 2025 %7 7.1.2025 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Research supports the use of mobile phone apps to promote medication adherence, but the use of and satisfaction with these apps among medically underserved patients with chronic illnesses remain unclear. Objective: This study reports on the overall use of and satisfaction with a medication adherence app (Medisafe) in a medically underserved population. Methods: Medically underserved adults who received care for one or more chronic illnesses at a federally qualified health center (FQHC) were randomized to an intervention group in a larger randomized controlled trial and used the app for 1 month (n=30), after which they completed a web-based survey. Objective data on app usage were provided as secondary data by the app company. Results: The participants were very satisfied with the app, with all participants (30/30, 100%) somewhat or strongly agreeing that they would recommend the app to family and friends. Participants strongly agreed (28/30, 93%) that the reminders helped them remember to take their medications at the correct time each day, and they (28/30, 93%) found the app easy to use. Additional features accessed by some included educational features and the adherence report. Participants noted the helpfulness of having a medication list on their phones, and some used it during medication reconciliation at doctor visits. Use of the Medfriend feature, which alerts a social support person if a medication is missed, was low (n=2), but those who used it were very positive about the feature. Conclusions: A commercially available medication adherence app was found to be useful by participants, and they were satisfied with the app and the additional features provided. The use of medication adherence mobile phone apps has the potential to positively influence chronic disease management in a medically underserved population on a large scale. Trial Registration: ClinicalTrials.gov NCT05098743; https://clinicaltrials.gov/study/NCT05098743 %M 39773694 %R 10.2196/63653 %U https://humanfactors.jmir.org/2025/1/e63653 %U https://doi.org/10.2196/63653 %U http://www.ncbi.nlm.nih.gov/pubmed/39773694 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e58563 %T Trajectories of Change, Illness Understanding, and Parental Worries in Children and Adolescents Undergoing Internet-Delivered Cognitive-Behavioral Therapy for Functional Abdominal Pain Disorders: Protocol for a Single-Case Design and Explorative Pilot Study %A Skovslund Nielsen,Eva %A Kallesøe,Karen %A Bennedsen Gehrt,Tine %A Bjerre-Nielsen,Ellen %A Lalouni,Maria %A Frostholm,Lisbeth %A Bonnert,Marianne %A Rask,Charlotte Ulrikka %+ Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Palle Juul-Jensens Boulevard 172,, Aarhus N, 8200, Denmark, 45 23882426, eniels@rm.dk %K functional abdominal pain disorders %K abdominal pain %K internet-based intervention %K cognitive behavioral therapy %K interoception %K attentional bias %K parental distress %K single case study %K children %K adolescents %K youth %K study protocol %K quality of life %K treatment %K medication %K psychological treatment %K psychology %D 2025 %7 7.1.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Functional abdominal pain disorders (FAPDs) are common in young people and are characterized by persistent or recurrent abdominal symptoms without apparent structural or biochemical abnormalities. FAPDs are associated with diminished quality of life, school absence, increased health care use, and comorbid anxiety and depression. Exposure-based internet-delivered cognitive behavioral therapy (ICBT) has demonstrated efficacy in alleviating abdominal symptoms and improving quality of life. However, a deeper understanding of effect mechanisms and identification of possible additional treatment targets could refine treatment. Objective: This protocol paper aims to describe a study focusing on children and adolescents undergoing ICBT for FAPDs, aiming to further investigate the underlying mechanisms of effect. Methods: Children (8-12 years), adolescents (13-17 years) with FAPDs, and their respective parents will be included for 10 weeks for ICBT. First, detailed trajectories of effect are examined through a randomized single-case design study involving 6 children and 6 adolescents (substudy 1). Following this, an open-ended explorative pilot study with 30 children and 30 adolescents explores potential illness-related cognitive biases and interoceptive accuracy before and after treatment (substudy 2). Finally, spanning across these 2 substudies, including all parents from substudies 1 and 2, we will assess parental distress and illness worries before and after treatment, and how these factors impact the treatment adherence and outcomes of the child or adolescent (substudy 3). Results: Recruitment of participants began in June 2022 and is finalized for substudy 1 and ongoing for substudies 2 and 3. Recruitment is expected to be completed by January 2025, with final data collection during April 2025. Conclusions: The findings have the potential to contribute to the ongoing improvement of specialized psychological treatment for FAPDs in young people. Trial Registration: ClinicalTrials.gov NCT05237882; https://clinicaltrials.gov/study/NCT05237882; ClinicalTrials.gov NCT05486585; https://clinicaltrials.gov/study/NCT05486585; OSF Registries osf.io/c49k7; https://osf.io/c49k7 International Registered Report Identifier (IRRID): DERR1-10.2196/58563 %M 39773759 %R 10.2196/58563 %U https://www.researchprotocols.org/2025/1/e58563 %U https://doi.org/10.2196/58563 %U http://www.ncbi.nlm.nih.gov/pubmed/39773759 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e65065 %T Association Between Intergenerational Support, Technology Perception and Trust, and Intention to Seek Medical Care on the Internet Among Chinese Older Adults: Cross-Sectional Questionnaire Study %A Jin,Hengjiang %A Qu,Ying %+ School of Journalism, Chongqing University, Number 174, Shazheng Street, Shapingba District, Chongqing, China, 86 15523596050, jinhj@cqu.edu.cn %K intergenerational support %K older adults %K internet medical intentions %K perceived technology %K trust %D 2025 %7 6.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Avoiding technological innovation does not simplify life. In fact, using internet-based medical services can enhance the quality of life for older adults. In the context of an aging population and the growing integration of information technology, the demand for internet-based medical services among older adults is gaining increased attention. While scholars have highlighted the important role of intergenerational support in promoting digital inclusion for older adults, research on the relationship between intergenerational support and older adults’ intentions to seek online care remains limited. Objective: This study aims (1) to explore the association between intergenerational support, online medical information, and older adults’ intention to seek medical care online, and (2) to examine the mediating role of technology perception and trust, as well as the moderating role of eHealth literacy. Methods: A cross-sectional survey was conducted in China, collecting 958 valid responses from older adults aged 60 years and above. A vast majority of participants were between the ages of 60 and 75 years (771/958, 80.5%). Of the 958 participants, 559 (58.4%) resided in rural areas, while 399 (41.6%) lived in urban areas. The survey included questions on intergenerational support, perceived usefulness, perceived ease of use, trust, online medical information, eHealth literacy, and the intention to seek medical care online. Structural equation modeling and linear regression analysis were applied to explore the relationship between intergenerational support and the intention to seek medical care on the internet. Results: Intergenerational support was positively associated with perceived ease of use (β=.292, P<.001), perceived usefulness (β=.437, P<.001), trust (β=.322, P<.001), and the intention to seek medical care online (β=.354, P<.001). Online medical information also positively affected the intention to seek medical care online among older adults (β=.109, P<.001). Perceived ease of use (β=.029, 95% CI 0.009-0.054), perceived usefulness (β=.089, 95% CI 0.050-0.130), and trust (β=.063, 95% CI 0.036-0.099) partially mediated the association between intergenerational support and the intention to seek medical care online. Further analysis found that perceived ease of use, perceived usefulness, and trust played a chain mediating role between intergenerational support and the intention to seek medical care online (β=.015, 95% CI 0.008-0.027; β=.022, 95% CI 0.012-0.036). Additionally, eHealth literacy played a moderating role in the relationship between intergenerational support and perceived ease of use (β=.177, P<.001), perceived usefulness (β=.073, P<.05), trust (β=.090, P<.01), and the intention to seek medical care online (β=.124, P<.001). Conclusions: An integrated model of health communication effects was constructed and validated, providing empirical support for the intention to seek medical care online and for the impact of health communication. This model also helps promote the role of technology in empowering the lives of seniors. %M 39761564 %R 10.2196/65065 %U https://www.jmir.org/2025/1/e65065 %U https://doi.org/10.2196/65065 %U http://www.ncbi.nlm.nih.gov/pubmed/39761564 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 8 %N %P e62795 %T Developing an Evidence- and Theory-Informed Mother-Daughter mHealth Intervention Prototype Targeting Physical Activity in Preteen Girls of Low Socioeconomic Position: Multiphase Co-Design Study %A Brennan,Carol %A ODonoghue,Grainne %A Keogh,Alison %A Rhodes,Ryan E %A Matthews,James %+ School of Public Health, Physiotherapy and Sports Science, University College Dublin, Belfield, Dublin 4, DO4C7X2, Ireland, 353 1 716 3449, carol.brennan1@ucdconnect.ie %K physical activity %K preteen girls %K socioeconomic position %K maternal support %K mHealth %K intervention %K co-design %K pediatric %K daughter %K design %K development %K behavior change technique %K Behaviour Change Wheel %K sedentary %K inactivity %D 2025 %7 6.1.2025 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Preteen girls of lower socioeconomic position are at increased risk of physical inactivity. Parental support, particularly from mothers, is positively correlated with girls’ physical activity levels. Consequently, family-based interventions are recognized as a promising approach to improve young people’s physical activity. However, the effects of these interventions on girls’ physical activity are often inconsistent, with calls for more rigorous, theory-informed, and co-designed family-based interventions to promote physical activity in this cohort. Objective: This study aimed to use co-design methods to develop an evidence- and theory-informed mother-daughter mobile health intervention prototype targeting physical activity in preteen girls. Methods: The intervention prototype was developed in accordance with the United Kingdom Medical Research Council framework, the Behaviour Change Wheel, the Theoretical Domains Framework, and the Behaviour Change Techniques Ontology. The Behaviour Change Intervention Ontology was also used to annotate the intervention characteristics. The co-design process incorporated three phases: (1) behavioral analysis, (2) the selection of intervention components, and (3) refinement of the intervention prototype. Throughout these phases, workshops were conducted with preteen girls (n=10), mothers of preteen girls (n=9), and primary school teachers (n=6), with additional input from an academic advisory panel. Results: This 3-phase co-design process resulted in the development of a theory-informed intervention that targeted two behaviors: (1) mothers’ engagement in a range of supportive behaviors for their daughters’ physical activity and (2) daughters’ physical activity behavior. Formative research identified 11 theoretical domains to be targeted as part of the intervention (eg, knowledge, skills, and beliefs about capabilities). These were to be targeted by 6 intervention functions (eg, education, persuasion, and modeling) and 27 behavior change techniques (eg, goal setting and self-monitoring). The co-design process resulted in a mobile app being chosen as the mode of delivery for the intervention. Conclusions: This paper offers a comprehensive description and analysis of using co-design methods to develop a mother-daughter mobile health intervention prototype that is ready for feasibility and acceptability testing. The Behaviour Change Wheel, Theoretical Domains Framework, and Behaviour Change Techniques Ontology provided a systematic and transparent theoretical foundation for developing the prototype by enabling the identification of potential pathways for behavior change. Annotating the Behaviour Change Intervention Ontology entities represents the intervention characteristics in a detailed and structured way that supports improved communication, replication, and implementation of interventions. %M 39761561 %R 10.2196/62795 %U https://pediatrics.jmir.org/2025/1/e62795 %U https://doi.org/10.2196/62795 %U http://www.ncbi.nlm.nih.gov/pubmed/39761561 %0 Journal Article %@ 2369-3762 %I JMIR Publications %V 11 %N %P e51101 %T Resilience Training Web App for National Health Service Keyworkers: Pilot Usability Study %A Burrell,Joanna %A Baker,Felicity %A Bennion,Matthew Russell %K resilience %K workplace stress %K National Health Service %K NHS keyworker %K digital learning %K digital health %K usability %K feasibility %K mental health %K pilot study %K learning %K training %K exercise %K primary care provider %K health care professional %K occupational health %K worker %K hospital %K emergency %K survey %K questionnaire %K mobile phone %D 2025 %7 6.1.2025 %9 %J JMIR Med Educ %G English %X Background: It is well established that frontline health care staff are particularly at risk of stress. Resilience is important to help staff to manage daily challenges and to protect against burnout. Objective: This study aimed to assess the usability and user perceptions of a resilience training web app developed to support health care keyworkers in understanding their own stress response and to help them put into place strategies to manage stress and to build resilience. Methods: Nurses (n=7) and other keyworkers (n=1), the target users for the resilience training web app, participated in the usability evaluation. Participants completed a pretraining questionnaire capturing basic demographic information and then used the training before completing a posttraining feedback questionnaire exploring the impact and usability of the web app. Results: From a sample of 8 keyworkers, 6 (75%) rated their current role as “sometimes” stressful. All 8 (100%) keyworkers found the training easy to understand, and 5 of 7 (71%) agreed that the training increased their understanding of both stress and resilience. Further, 6 of 8 (75%) agreed that the resilience model had helped them to understand what resilience is. Many of the keyworkers (6/8, 75%) agreed that the content was relevant to them. Furthermore, 6 of 8 (75%) agreed that they were likely to act to develop their resilience following completion of the training. Conclusions: This study tested the usability of a web app for resilience training specifically targeting National Health Service keyworkers. This work preceded a larger scale usability study, and it is hoped this study will help guide other studies to develop similar programs in clinical settings. %R 10.2196/51101 %U https://mededu.jmir.org/2025/1/e51101 %U https://doi.org/10.2196/51101 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e54241 %T Social Media Potential and Impact on Changing Behaviors and Actions in Skin Health Promotion: Systematic Review %A Brzozowska,Justyna Martyna %A Gotlib,Joanna %+ School of Medical & Health Sciences, University of Economics and Human Sciences in Warsaw, 59 Okopowa Street, Warsaw, 01-043, Poland, 48 604441820, justyna@kardas.pl %K skin %K social media %K prevention %K behavioral intervention %K skin cancer %K sun protection %K acne %D 2025 %7 6.1.2025 %9 Review %J J Med Internet Res %G English %X Background: Social media is used as a tool for information exchange, entertainment, education, and intervention. Intervention efforts attempt to engage users in skin health. Objective: This review aimed to collect and summarize research assessing the impact of social media on skin health promotion activities undertaken by social media users. Methods: In accordance with the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines, the following scientific databases were searched: Scopus, Web of Science, PubMed, Academic Search Ultimate (via EBSCO), Academic Research Source eJournals (via EBSCO), ERIC (via EBSCO), Health Source: Consumer Edition (via EBSCO), and Health Source: Nursing/Academic Edition (via EBSCO). Using ProQuest Dissertations and Theses, OpenGrey, Grey Literature Report, and MedNar, the search was supplemented with gray literature. Articles on skin care, skin health, skin diseases, skin protection, and educational activities promoting healthy skin on social media were selected for review (search date: February 6, 2023). The following qualification criteria were used: original research; research conducted on social media; and research topics regarding educational activities in skin health promotion, skin care, skin health, skin diseases, and skin protection. To assess the risk of bias, the following tools were used: the Cochrane Collaboration tool for risk-of-bias assessment (randomized controlled trials and quasi-experimental studies) and the Centre for Evidence-Based Medicine checklist (cross-sectional studies). Results: Altogether, 1558 works were considered, of which 23 (1.48%) qualified, with 3 (13%) studies on acne and 20 (87%) on skin cancer, sunscreen, and tanning. Social media interventions were dealt with in 65% (15/23) of the studies. The review made it possible to investigate cognitive and cognitive-behavioral interventions. In both observational and interventional studies, the most frequently discussed topics were skin exposure and protection against UV radiation and skin cancer. The analyzed research showed that social media is a source of information. Visualization has a strong impact on users. The involvement of social media users is measured through the amount of content shared and contributes to changing attitudes and behaviors regarding skin health. Conclusions: This review outlined the impact of social media, despite its heterogeneity, on users’ skin health behaviors, attitudes, and actions. It identified strategies for digital interventions to promote skin health. In health sciences, a standardized tool is needed to assess the quality of social media digital interventions. This review has several limitations: only articles written in English were considered; ongoing studies were omitted; and there was a small number of interventional studies on acne and a lack of research on daily skin care, education, and antiaging activities on social media. Another limitation, resulting from the topic being too broad, was a failure to perform quantitative data analysis, resulting in the studies that qualified for the review being heterogeneous. %M 39761100 %R 10.2196/54241 %U https://www.jmir.org/2025/1/e54241 %U https://doi.org/10.2196/54241 %U http://www.ncbi.nlm.nih.gov/pubmed/39761100 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e58611 %T A Digital Parenting Intervention With Intimate Partner Violence Prevention Content: Quantitative Pre-Post Pilot Study %A Schafer,Moa %A Lachman,Jamie %A Zinser,Paula %A Calderón Alfaro,Francisco Antonio %A Han,Qing %A Facciola,Chiara %A Clements,Lily %A Gardner,Frances %A Haupt Ronnie,Genevieve %A Sheil,Ross %+ Centre for Evidence Based Intervention, Department of Social Policy and Intervention, University of Oxford, Barnett House, 32-37 Wellington Square, Oxford, OX1 2ER, United Kingdom, 44 01865 2703, moa.schafer@spi.ox.ac.uk %K intimate partner violence %K SMS text messaging %K chatbot %K user engagement %K parenting %K violence %K mobile phone %D 2025 %7 3.1.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: Intimate partner violence (IPV) and violence against children are global issues with severe consequences. Intersections shared by the 2 forms of violence have led to calls for joint programming efforts to prevent both IPV and violence against children. Parenting programs have been identified as a key entry point for addressing multiple forms of family violence. Building on the IPV prevention material that has been integrated into the parenting program ParentText, a digital parenting chatbot, this pilot study seeks to explore parents’ engagement with the IPV prevention content in ParentText and explore preliminary changes in IPV. Objective: This study aimed to assess parents’ and caregivers’ level of engagement with the IPV prevention material in the ParentText chatbot and explore preliminary changes in experiences and perpetration of IPV, attitudes toward IPV, and gender-equitable behaviors following the intervention. Methods: Caregivers of children aged between 0 and 18 years were recruited through convenience sampling by research assistants in Cape Town, South Africa, and by UNICEF (United Nations Children's Fund) Jamaica staff in 3 parishes of Jamaica. Quantitative data from women in Jamaica (n=28) and South Africa (n=19) and men in South Africa (n=21) were collected electronically via weblinks sent to caregivers’ phones using Open Data Kit. The primary outcome was IPV experience (women) and perpetration (men), with secondary outcomes including gender-equitable behaviors and attitudes toward IPV. Descriptive statistics were used to report sociodemographic characteristics and engagement outcomes. Chi-square tests and 2-tailed paired dependent-sample t tests were used to investigate potential changes in IPV outcomes between pretest and posttest. Results: The average daily interaction rate with the program was 0.57 and 0.59 interactions per day for women and men in South Africa, and 0.21 for women in Jamaica. The rate of completion of at least 1 IPV prevention topic was 25% (5/20) for women and 5% (1/20) for men in South Africa, and 21% (6/28) for women in Jamaica. Exploratory analyses indicated significant pre-post reductions in overall IPV experience among women in South Africa (P=.01) and Jamaica (P=.01) and in men’s overall harmful IPV attitudes (P=.01) and increases in men’s overall gender-equitable behaviors (P=.02) in South Africa. Conclusions: To the best of our knowledge, this is the first pilot study to investigate user engagement with and indicative outcomes of a digital parenting intervention with integrated IPV prevention content. Study findings provide valuable insights into user interactions with the chatbot and shed light on challenges related to low levels of chatbot engagement. Indicative results suggest promising yet modest reductions in IPV and improvements in attitudes after the program. Further research using a randomized controlled trial is warranted to establish causality. %M 39753219 %R 10.2196/58611 %U https://formative.jmir.org/2025/1/e58611 %U https://doi.org/10.2196/58611 %U http://www.ncbi.nlm.nih.gov/pubmed/39753219 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 12 %N %P e57795 %T User Experiences of and Preferences for Self-Guided Digital Interventions for the Treatment of Mild to Moderate Eating Disorders: Systematic Review and Metasynthesis %A Cheung,Lauryn Gar-Mun %A Thomas,Pamela Carien %A Brvar,Eva %A Rowe,Sarah %+ Division of Psychiatry, University College London, Maple House, 149 Tottenham Ct Rd, London, W1T 7NF, United Kingdom, 44 020 7679 2000, s.rowe@ucl.ac.uk %K eating disorders %K anorexia %K bulimia %K binge eating %K other specified feeding or eating disorder %K OSFED %K intervention %K digital intervention %K self-help %K systematic review %D 2025 %7 3.1.2025 %9 Review %J JMIR Ment Health %G English %X Background: Digital interventions typically involve using smartphones or PCs to access online or downloadable self-help and may offer a more accessible and convenient option than face-to-face interventions for some people with mild to moderate eating disorders. They have been shown to substantially reduce eating disorder symptoms, but treatment dropout rates are higher than for face-to-face interventions. We need to understand user experiences and preferences for digital interventions to support the design and development of user-centered digital interventions that are engaging and meet users’ needs. Objective: This study aims to understand user experiences and user preferences for digital interventions that aim to reduce mild to moderate eating disorder symptoms in adults. Methods: We conducted a metasynthesis of qualitative studies. We searched 6 databases for published and unpublished literature from 2013 to 2024. We searched for studies conducted in naturalistic or outpatient settings, using primarily unguided digital self-help interventions designed to reduce eating disorder symptoms in adults with mild to moderate eating disorders. We conducted a thematic synthesis using line-by-line coding of the results and findings from each study to generate themes. Results: A total of 8 studies were included after screening 3695 search results. Overall, 7 metathemes were identified. The identified metathemes included the appeal of digital interventions, role of digital interventions in treatment, value of support in treatment, communication at the right level, importance of engagement, shaping knowledge to improve eating disorder behaviors, and design of the digital intervention. Users had positive experiences with digital interventions and perceived them as helpful for self-reflection and mindfulness. Users found digital interventions to be convenient and flexible and that they fit with their lifestyle. Overall, users noticed reduced eating disorder thoughts and behaviors. However, digital interventions were not generally perceived as a sufficient treatment that could replace traditional face-to-face treatment. Users have individual needs, so an ideal intervention would offer personalized content and functions. Conclusions: Users found digital interventions for eating disorders practical and effective but stressed the need for interventions to address the full range of symptoms, severity, and individual needs. Future digital interventions should be cocreated with users and offer more personalization. Further research is needed to determine the appropriate balance of professional and peer support and whether these interventions should serve as the first step in the stepped care model. Trial Registration: PROSPERO CRD42023426932; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=426932 %M 39752210 %R 10.2196/57795 %U https://mental.jmir.org/2025/1/e57795 %U https://doi.org/10.2196/57795 %U http://www.ncbi.nlm.nih.gov/pubmed/39752210 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 8 %N %P e59489 %T The Impact of Parental Support on Adherence to Therapist-Assisted Internet-Delivered Acceptance and Commitment Therapy in Primary Care for Adolescents With Anxiety: Naturalistic 12-Month Follow-Up Study %A Larsson,Anna %A Weineland,Sandra %A Nissling,Linnea %A Lilja,Josefine L %+ Research, Education, Development & Innovation, Primary Health Care, Region Västra Götaland, FoU primär och nära vård Södra Älvsborg, Sven Eriksonsplatsen 4, Borås, 503 38, Sweden, 46 104359410, anna.caroline.larsson@vgregion.se %K adolescents %K parental support %K anxiety %K depression %K primary care %K mental health %K ACT %K acceptance and commitment therapy %K iACT %K internet-delivered acceptance and commitment therapy %D 2025 %7 3.1.2025 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Mental health problems among adolescents are increasing, and internet-delivered acceptance and commitment therapy (iACT) constitutes a possible way to improve access to care while reducing costs. Nevertheless, few studies have investigated iACT for adolescents in regular primary care nor the role of parental support. Objective: This is an exploratory evaluation investigating iACT, with or without parental support, for adolescents. The aims were to examine treatment adherence, symptoms of anxiety and depression, psychological flexibility, and overall functioning. Methods: Adolescents with anxiety were recruited within the regular primary care patient flow during the implementation phase of therapist-assisted iACT for adolescents. Assessment and inclusion were executed face-to-face. Due to organizational reasons, the assignment of treatment methods could not be randomized. Adherence was investigated by measuring the number of completed modules. Outcome measures were collected by self-assessment questionnaires including the Revised Children’s Anxiety and Depression Scale and Avoidance and Fusion Questionnaire for Youth, as well as interviews using the Children’s Global Assessment Scale. The analysis was performed as an exploratory evaluation using descriptive data for treatment adherence and nonparametric within-group analysis with the Wilcoxon signed rank test for related samples and treatment outcomes. This evaluation is naturalistic, and the results are preliminary and of a hypothesis-generating character and should be handled with caution. Results: The iACT group without parental support (n=9) exhibited a gradual dropout throughout the treatment period (n=5), whereas the iACT group with parental support (n=15) exhibited the lowest number of dropouts from treatment before completion (n=2), of which all occurred during the second half of treatment. The within-group, per-protocol analyses for the Revised Children’s Anxiety and Depression Scale indicated reduced symptoms of anxiety and depression at the 12-month follow-up (z score: –2.94; P=.003; r=–0.6). The within-group, per-protocol analyses for the Avoidance and Fusion Questionnaire for Youth indicated increased psychological flexibility at the 12-month follow-up (z score: –2.54; P=.01; r=0.55). Nevertheless, no differences in overall functioning measured by the Children’s Global Assessment Scale were found. Conclusions: The results indicate that parental support might play a role in treatment adherence in iACT for adolescents with anxiety. Moreover, the outcome measures suggest that iACT for adolescents in primary care could constitute an effective treatment for both anxiety and depression, as indicated by the symptom reduction and increased psychological flexibility, maintained at the 12-month follow-up. Nevertheless, due to a small and gender-biased sample size with a large proportion of dropouts and missing data, a nonrandomized assignment of intervention, and an analysis limited to within group, this study should be considered an explorative evaluation rather than an outcome study. %M 39752209 %R 10.2196/59489 %U https://pediatrics.jmir.org/2025/1/e59489 %U https://doi.org/10.2196/59489 %U http://www.ncbi.nlm.nih.gov/pubmed/39752209 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e53205 %T Association Between Digital Front Doors and Social Care Use for Community-Dwelling Adults in England: Cross-Sectional Study %A Zhang,Jinbao %A Prunty,Jonathan E %A Charles,Alison C %A Forder,Julien %+ Personal Social Services Research Unit, University of Kent, Cornwallis Central, Giles Ln, Canterbury, CT2 7NF, United Kingdom, 44 01227 823862, j.zhang@kent.ac.uk %K social care support %K long term care %K access %K front door %K easy-read %K self-assessment %K system navigation %K digital system %K digital technology %K internet %D 2025 %7 2.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Requests for public social care support can be made through an online portal. These digital “front doors” can help people navigate complex social care systems and access services. These systems can be set up in different ways, but there is little evidence about the impact of alternative arrangements. Digital front-door systems should help people better access services, particularly low-intensity services (high-intensity care is likely to require a full in-person assessment). Objective: This study aimed to investigate the association between 2 primary digital front door arrangements, easy-read information, and self-assessment tools provided on official websites, and the type of social care support that is offered: ongoing low-level support (OLLS), short-term care (STC) and long-term care (LTC). Methods: Information on front door arrangements was collected from the official websites of 152 English local authorities in 2021. We conducted a cross-sectional analysis using aggregated service use data from official government returns at the local authority level. The independent variables were derived from the policy information collected, specifically focusing on the availability of online digital easy-read information and self-assessment tools for adults and caregivers through official websites. The dependent variables were the rates of using social care support, including OLLS, STC, and LTC, across different age groups: the adult population (aged 18 and older), younger population (aged between 18 and 64 years), and older population (aged 65 and older). Multivariate regression analysis was used to examine the association between digital front door arrangements and access to social care support, controlling for population size, dependency level, and financial need factors. Results: Less than 20% (27/147) of local authorities provided an integrated digital easy-read format as part of their digital front door system with about 25% (37/147) adopting digital self-assessment within their system. We found that local authorities that offered an integrated digital easy-read information format showed higher rates of using OLLS (β coefficient=0.54; P=.03; but no statistically significant association with LTC and STC). The provision of an online self-assessment system was not associated with service use in the 1-year (2021) cross-sectional estimate, but when 2 years (2020 and 2021) of service-use data were analyzed, a significant positive association was found on OLLS rates (β coefficient=0.41; P=.21). Notably, these findings were consistent across different age groups. Conclusions: These findings are consistent with our hypothesis that digital systems with built-in easy-read and self-assessment may make access to (low-intensity) services easier for people. Adoption of these arrangements could potentially help increase the uptake of support among those who are eligible, with expected benefits for their care-related well-being. Given the limited adoption of the digital front door by local authorities in England, expanding their use could improve care-related outcomes and save social care costs. %M 39746193 %R 10.2196/53205 %U https://www.jmir.org/2025/1/e53205 %U https://doi.org/10.2196/53205 %U http://www.ncbi.nlm.nih.gov/pubmed/39746193 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e54438 %T Translation Effectiveness of Offset Heart Rate Biofeedback as a Mindless Intervention for Alcohol Craving Among Risky Drinkers: Controlled Experiment %A Zhao,Yiran %A Arora,Jatin %A Tao,Yujie %A Miller,Dave B %A Adams,Alexander T %A Choudhury,Tanzeem %+ Department of Information Science, Cornell University, 2 West Loop Rd, New York, NY, 10044, United States, 1 240 888 3213, yz2647@cornell.edu %K wearable device %K alcohol craving %K risky drinking %K digital intervention %K entrainment %K offset heart rate biofeedback %K mindless intervention %D 2024 %7 31.12.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital and wearable intervention systems promise to improve how people manage their behavioral health conditions by making interventions available when the user can best benefit from them. However, existing interventions are obtrusive because they require attention and motivation to engage in, limiting the effectiveness of such systems in demanding contexts, such as when the user experiences alcohol craving. Mindless interventions, developed by the human-computer interaction community, offer an opportunity to intervene unobtrusively. Offset heart rate biofeedback is an iconic type of mindless intervention powered by entrainment and can mitigate the physiological and psychological response to stressors. Objective: This work aimed to characterize the translational effectiveness of offset heart rate biofeedback on cue-elicit alcohol craving among risky drinkers. Methods: We conducted an out-of-lab, between-group, controlled experiment with 26 participants who performed harmful or hazardous drinking. The control group served as negative control and received no intervention, while the experimental group received offset heart rate biofeedback during alcohol exposure and recovery. We elicited alcohol cravings through a series of alcohol cues, including performing mental imagery, viewing alcohol images, and sniffing alcohol. We measured the physiological response to alcohol (ie, heart rate variability), self-reported craving, and self-reported anxiety. We constructed linear mixed-effects models to understand the effect of intervention during alcohol exposure and alcohol recovery after exposure. Following the linear mixed effect model, we conducted pair-wise comparisons for measures between the control and experimental groups. Results: We found that offset heart rate biofeedback significantly reduced the increase in heart rate variability (P=.01 and P=.052) and self-reported craving (P=.04 and P=.02) in response to alcohol cues. Participants’ anxiety was not affected by either the alcohol cues or the offset heart rate biofeedback. Conclusions: Offset heart rate biofeedback has the potential to immediately and unobtrusively mitigate cue-elicit alcohol craving among risky drinkers. The results of this study opened new opportunities for digital and wearable interventions to mitigate alcohol craving, either as wellness apps for risky drinkers or as digital prescriptions and integration with sensing systems for people with alcohol dependency. %M 39740221 %R 10.2196/54438 %U https://formative.jmir.org/2024/1/e54438 %U https://doi.org/10.2196/54438 %U http://www.ncbi.nlm.nih.gov/pubmed/39740221 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e57458 %T Use of Extrinsic Motivators to Improve the BMI of Obese or Overweight Adolescents: Systematic Review %A Gonçalves,Ana %A Simões,Pedro Augusto %A Sousa-Pinto,Bernardo %A Taveira-Gomes,Tiago %+ Faculty of Medicine, Universidade do Porto, Alameda Prof. Hernâni Monteiro, Porto, 4200-319, Portugal, 351 225513600, an.goncalves@ubi.pt %K adolescents %K obesity %K overweight %K extrinsic motivators %K body mass index %D 2024 %7 30.12.2024 %9 Review %J J Med Internet Res %G English %X Background: The prevalence of overweight and obesity is increasing at an alarming rate in children and adolescents worldwide. Given the dimensions of the problem, the treatment of childhood obesity is considered extremely important. Current evidence indicates that behavioral and cognitive behavioral strategies combined with diet and physical activity approaches may assist in reducing adolescent obesity. Objective: The purpose of this systematic review was to evaluate the use of extrinsic motivators for improving the BMI of obese or overweight adolescents.  Methods: The inclusion criteria were as follows: (1) overweight or obese adolescents, (2) intervention using extrinsic motivators, and (3) outcome variables related to weight status. The exclusion criterion was the presence of an associated chronic disease. The search process was conducted in PubMed and Web of Science (last searched on April 23, 2023). The risk of bias was evaluated independently by 2 authors using Cochrane tools (RoB2 [randomized controlled trials], ROBINS-I, and ROBINS-E). Results: From 3163 studies identified, 20 articles (corresponding to 18 studies) were included in the analysis. The studies differed in terms of study design, sample size, follow-up duration, outcomes reported, and extrinsic motivators used. Most of the studies had videogames or apps as interventions. Of the 18 studies, 9 (50%) reported a statistically significant decrease in BMI. The most used extrinsic motivators were “motivation” (n=13), “feedback” (n=10), and “rewards” (n=9). Among the motivators, “reminders” (100%) and “peer-support” (80%) appeared to have high impacts on BMI reduction.  Conclusions: The heterogeneity of the included studies made analysis difficult. No study evaluated extrinsic motivators in isolation. Most of the studies had a moderate or high risk of bias. The extrinsic motivators “reminders” and “peer-support” appeared to be useful. Further studies are needed, and these should include well-designed randomized controlled trials and studies involving homogeneity in BMI measures, consistent extrinsic motivator definitions, and longer durations to better understand the long-term impacts of extrinsic motivators on weight management success. %M 39576963 %R 10.2196/57458 %U https://www.jmir.org/2024/1/e57458 %U https://doi.org/10.2196/57458 %U http://www.ncbi.nlm.nih.gov/pubmed/39576963 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e55924 %T Characteristics and Outcomes of mHealth Interventions in Psychosis: Systematic Mapping Review %A Loh,Pei Yi %A Martinengo,Laura %A Heaukulani,Creighton %A Tan,Xin Yang %A Hng,Moses %A Cheah,Yong Yin %A Morris,Robert J T %A Tudor Car,Lorainne %A Lee,Jimmy %+ Institute of Mental Health, 10 Buangkok View, Singapore, 539747​, Singapore, 65 63892000, jimmy_lee@imh.com.sg %K mHealth %K digital health %K mobile applications %K psychosis %K schizophrenia %K schizophrenia spectrum %K psychotic disorders %K mapping review %D 2024 %7 23.12.2024 %9 Review %J J Med Internet Res %G English %X Background: Mobile health (mHealth) interventions have gained popularity in augmenting psychiatric care for adults with psychosis. Interest has grown in leveraging mHealth to empower individuals living with severe mental illness and extend continuity of care beyond the hospital to the community. However, reported outcomes have been mixed, likely attributed in part to the intervention and adopted outcomes, which affected between-study comparisons. Objective: This study aimed to critically review outcome measures used to evaluate mHealth interventions for adults with psychosis in relation to the characteristics of mHealth interventions. Methods: A systematic mapping review was conducted. We searched PubMed, CINAHL, Embase, PsycINFO, and Cochrane Libraries from 1973 to the present. Selection criteria included randomized controlled studies of mHealth interventions in adults diagnosed with schizophrenia spectrum disorders. Reviewers worked in pairs to screen and extract data from included studies independently using a standardized form; disagreements were resolved by consensus with an independent reviewer. We report our findings in line with PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Results: A total of 1703 citations were screened; 29 publications reporting on 23 studies were included in this review. mHealth interventions for psychosis span a wide range, with psychological therapy being the most-deployed intervention (12/23, 52%), followed by psychoeducation (8/23, 35%) and active self-monitoring (8/23, 35%). Several mHealth interventions for psychosis targeted multiple pillars of biopsychosocial well-being (10/23, 43%); the bulk of interventions (16/23, 70%) incorporated features promoting users’ self-management. The majority of mHealth interventions were delivered through applications (14/23, 61%) as the main medium and smartphones (17/23, 74%) as the main channel of delivery. Interventions were primarily administered in the outpatient and community settings (16/23, 70%); many were also blended with in-person sessions (11/23, 48%) or guided remotely (6/23, 26%) by persons, including health care providers or trained peer supporters. The severity of psychosis-related symptoms (21/23, 91%) was the most prevalent outcome, of which positive symptoms (13/23, 57%), mood and anxiety (10/23, 43%), and overall psychopathology severity (9/23, 39%) were most commonly measured. Patient-centric outcomes, including well-being (17/23, 74%)—particularly quality of life (10/23, 43%)—and user experience (15/23, 65%), including feasibility (7/23, 30%), acceptability (7/23, 30%), and engagement (7/23, 26%). Notably, outcome choices remained diverse despite stratification by type of mHealth intervention. Conclusions: mHealth interventions for psychosis encompass a wide range of modalities and use outcome measures that probe various social and behavioral determinants of health. These should be considered complex interventions, and a holistic evaluation approach combining clinical and patient-centric outcomes is recommended. %M 39714907 %R 10.2196/55924 %U https://www.jmir.org/2024/1/e55924 %U https://doi.org/10.2196/55924 %U http://www.ncbi.nlm.nih.gov/pubmed/39714907 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e54366 %T Investigating eHealth Lifestyle Interventions for Vulnerable Pregnant Women: Scoping Review of Facilitators and Barriers %A Smit,Ashley JP %A Al-Dhahir,Isra %A Schiphof-Godart,Lieke %A Breeman,Linda D %A Evers,Andrea WM %A Joosten,Koen FM %+ Department of Neonatal and Pediatric Intensive Care, Erasmus Medical Center, Sophia Children's Hospital, Dr. Molewaterplein 40, Rotterdam, 3015 GD, Netherlands, 31 10 704 0704, a.j.p.smit@erasmusmc.nl %K eHealth %K pregnancy %K vulnerability %K socioeconomic status %K lifestyle intervention %K intervention development %K barriers %K facilitators %K mobile phone %K PRISMA %D 2024 %7 20.12.2024 %9 Review %J J Med Internet Res %G English %X Background: The maintenance of a healthy lifestyle significantly influences pregnancy outcomes. Certain pregnant women are more at risk of engaging in unhealthy behaviors due to factors such as having a low socioeconomic position and low social capital. eHealth interventions tailored to pregnant women affected by these vulnerability factors can provide support and motivation for healthier choices. However, there is still a lack of insight into how interventions for this target group are best designed, used, and implemented and how vulnerable pregnant women are best reached. Objective: This review aimed to identify the strategies used in the design, reach, use, and implementation phases of eHealth lifestyle interventions for vulnerable pregnant women; assess whether these strategies acted as facilitators; and identify barriers that were encountered. Methods: We conducted a search on MEDLINE, Embase, Web of Science, CINAHL, and Google Scholar for studies that described an eHealth intervention for vulnerable pregnant women focusing on at least one lifestyle component (diet, physical activity, alcohol consumption, smoking, stress, or sleep) and provided information on the design, reach, use, or implementation of the intervention. Results: The literature search identified 3904 records, of which 29 (0.74%) met our inclusion criteria. These 29 articles described 20 eHealth lifestyle interventions, which were primarily delivered through apps and frequently targeted multiple lifestyle components simultaneously. Barriers identified in the design and use phases included financial aspects (eg, budgetary constraints) and technological challenges for the target group (eg, limited internet connectivity). In addition, barriers were encountered in reaching vulnerable pregnant women, including a lack of interest and time constraints among eligible participants and limited support from health care providers. Facilitators identified in the design and use phases included collaborating with the target group and other stakeholders (eg, health care providers), leveraging existing eHealth platforms for modifications or extensions, and adhering to clinical and best practice guidelines and behavior change frameworks. Furthermore, tailoring (eg, matching the content of the intervention to the target groups’ norms and values) and the use of incentives (eg, payments for abstaining from unhealthy behavior) were identified as potential facilitators to eHealth use. Facilitators in the interventions’ reach and implementation phases included stakeholder collaboration and a low workload for the intervention deliverers involved in these phases. Conclusions: This scoping review offers a comprehensive overview of strategies used in different phases of eHealth lifestyle interventions for vulnerable pregnant women, highlighting specific barriers and facilitators. Limited reporting on the impact of the strategies used and barriers encountered hinders a complete identification of facilitators and barriers. Nevertheless, this review sheds light on how to optimize the development of eHealth lifestyle interventions for vulnerable pregnant women, ultimately enhancing the health of both future mothers and their offspring. %M 39705692 %R 10.2196/54366 %U https://www.jmir.org/2024/1/e54366 %U https://doi.org/10.2196/54366 %U http://www.ncbi.nlm.nih.gov/pubmed/39705692 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e57774 %T mHealth Engagement for Antiretroviral Medication Adherence Among People With HIV and Substance Use Disorders: Observational Study %A Mi,Ranran Z %A Yang,Ellie Fan %A Tahk,Alexander %A Tarfa,Adati %A Cotter,Lynne M %A Lu,Linqi %A Yang,Sijia %A Gustafson Sr,David H %A Westergaard,Ryan %A Shah,Dhavan %+ School of Communication, Illinois State University, 4480 School Of Communication, FEL Fell Hall 434, Normal, IL, 61790, United States, 1 (309) 438 3671, fyang8@ilstu.edu %K information and communication technologies %K ICTs %K mHealth %K medication adherence %K HIV care %K antiretroviral therapy %K substance use %K social support %K patient management %K health disparities %K information technology %K communication technology %K mobile health %K app %K clinic %K United States %K participants %K mobile phone %D 2024 %7 20.12.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite the increasing popularity of mobile health (mHealth) technologies, little is known about which types of mHealth system engagement might affect the maintenance of antiretroviral therapy among people with HIV and substance use disorders. Objective: This study aimed to use longitudinal and detailed system logs and weekly survey data to test a mediation model, where mHealth engagement indicators were treated as predictors, substance use and confidence in HIV management were treated as joint mediators, and antiretroviral therapy adherence was treated as the outcome. We further distinguished the initiation and intensity of system engagement by mode (expression vs reception) and by communication levels (intraindividual vs dyadic vs network). Methods: Tailored for people with HIV living with substance use disorders, the mHealth app was distributed among 208 participants aged >18 years from 2 US health clinics. Supervised by medical professionals, participants received weekly surveys through the app to report their health status and medication adherence data. System use was passively collected through the app, operationalized as transformed click-level data, aggregated weekly, and connected to survey responses with a 7-day lagged window. Using the weekly check-in record provided by participants as the unit of analysis (N=681), linear regression and structure equation models with cluster-robust SEs were used for analyses, controlling within-person autocorrelation and group-level error correlations. Racial groups were examined as moderators in the structure equation models. Results: We found that (1) intensity, not initiation, of system use; (2) dyadic message expression and reception; and (3) network expression positively predicted medication adherence through joint mediators (substance use and confidence in HIV management). However, intraindividual reception (ie, rereading saved entries for personal motivation) negatively predicts medication adherence through joint mediators. We also found Black participants have distinct usage patterns, suggesting the need to tailor mHealth interventions for this subgroup. Conclusions: These findings highlight the importance of considering the intensity of system engagement, rather than initiation alone, when designing mHealth interventions for people with HIV and tailoring these systems to Black communities. %M 39705693 %R 10.2196/57774 %U https://www.jmir.org/2024/1/e57774 %U https://doi.org/10.2196/57774 %U http://www.ncbi.nlm.nih.gov/pubmed/39705693 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 10 %N %P e48627 %T Designing Positive Psychology Interventions for Social Media: Cross-Sectional Web-Based Experiment With Young Adults With Cancer %A Lazard,Allison J %A Vereen,Rhyan N %A Zhou,Jieni %A Nichols,Hazel B %A Pulido,Marlyn %A Swift,Catherine %A Dasgupta,Nabarun %A Fredrickson,Barbara L %K young adult %K cancer survivors %K social media %K positive psychology %K acceptability %K feasibility %K youth %K cancer %K psychosocial %K self-efficacy %K social connection %K positive emotion %K emotion %K social engagement %D 2024 %7 20.12.2024 %9 %J JMIR Cancer %G English %X Background: Young adults (ages 18‐39 years) with cancer face unique risks for negative psychosocial outcomes. These risks could be lessened with positive psychology interventions adapted for social media if intervention messages encourage intentions to do the activities and positive message reactions and if young adults with cancer perceive few downsides. Objective: This study aimed to assess whether social media messages from evidence-based positive psychology interventions encouraged intentions to do the intervention activities and intended positive message reactions, overall and among sociodemographic or cancer characteristic subgroups. We also aimed to identify perceived downsides of the activity that would negatively impact the interventions’ feasibility. Methods: Young adults (ages 18‐39 years, cancer diagnosis ages 15‐39 years) were randomized to a between-persons web-based experiment. Participants viewed a social media message with social context cues (vs not) for 1 of 2 types of intervention (acts of kindness vs social connectedness). Participants reported intentions to do the activity, along with their perceived social presence in the message (how much they felt the sense of others) and forecasted positivity resonance (whether they would experience socially connected positive emotions when doing the activity), with 5-point items. Participants also reported their self-efficacy (how certain they can do the intervention activity) with a 0‐100 item and potential downsides of the activity categorically. Results: More than 4 out of 5 young adults with cancer (N=396) reported they “somewhat” (coded as 3) to “extremely” (5) intended to do the intervention activity (336/396, 84.8%; mean ranged from 3.4‐3.6, SD 0.9-1.0), perceived social presence in the messages (350/396, 88.4%; mean 3.8, SD 0.7), and forecasted positivity resonance (349/396, 88.1%; mean 3.8‐3.9, SD 0.8). Participants reported having self-efficacy to complete the activity (mean 70.7% of possible 100%, SD 15.4%‐17.2%). Most (320/396, 80.8%) did not think of the downsides of the interventions. Messages with social context cues (vs not) and both intervention types were rated similarly (all P>.05). Black young adults reported lower intentions, perceived social presence, and forecasted positivity resonance than White young adults (all P<.001). Participants in active treatment (vs completed) reported greater intentions to do the activities (P<.001). Conclusions: Positive psychology intervention messages adapted for social media were perceived as acceptable and feasible among young adults with cancer. The social media–based messages encouraged increasing one’s social connectedness and performing acts of kindness. Young adults with cancer also predicted they would have feelings of positive social engagement (positivity resonance) when doing the interventions—the key ingredient for experiencing the health benefits of these activities. This study provides promising evidence for the development of age-appropriate, highly scalable interventions to improve psychosocial health among young adults with cancer. %R 10.2196/48627 %U https://cancer.jmir.org/2024/1/e48627 %U https://doi.org/10.2196/48627 %0 Journal Article %@ 2564-1891 %I JMIR Publications %V 4 %N %P e53424 %T Application of a Language Model Tool for COVID-19 Vaccine Adverse Event Monitoring Using Web and Social Media Content: Algorithm Development and Validation Study %A Daluwatte,Chathuri %A Khromava,Alena %A Chen,Yuning %A Serradell,Laurence %A Chabanon,Anne-Laure %A Chan-Ou-Teung,Anthony %A Molony,Cliona %A Juhaeri,Juhaeri %+ Epidemiology and Benefit-Risk Department, Sanofi, 1755 Steeles Ave West, Toronto, ON, M2R 3T4, Canada, 1 4166672753, alena.khromava@sanofi.com %K adverse event %K COVID-19 %K detection %K large language model %K mass vaccination %K natural language processing %K pharmacovigilance %K safety %K social media %K vaccine %D 2024 %7 20.12.2024 %9 Original Paper %J JMIR Infodemiology %G English %X Background: Spontaneous pharmacovigilance reporting systems are the main data source for signal detection for vaccines. However, there is a large time lag between the occurrence of an adverse event (AE) and the availability for analysis. With global mass COVID-19 vaccination campaigns, social media, and web content, there is an opportunity for real-time, faster monitoring of AEs potentially related to COVID-19 vaccine use. Our work aims to detect AEs from social media to augment those from spontaneous reporting systems. Objective: This study aims to monitor AEs shared in social media and online support groups using medical context-aware natural language processing language models. Methods: We developed a language model–based web app to analyze social media, patient blogs, and forums (from 190 countries in 61 languages) around COVID-19 vaccine–related keywords. Following machine translation to English, lay language safety terms (ie, AEs) were observed using the PubmedBERT-based named-entity recognition model (precision=0.76 and recall=0.82) and mapped to Medical Dictionary for Regulatory Activities (MedDRA) terms using knowledge graphs (MedDRA terminology is an internationally used set of terms relating to medical conditions, medicines, and medical devices that are developed and registered under the auspices of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use). Weekly and cumulative aggregated AE counts, proportions, and ratios were displayed via visual analytics, such as word clouds. Results: Most AEs were identified in 2021, with fewer in 2022. AEs observed using the web app were consistent with AEs communicated by health authorities shortly before or within the same period. Conclusions: Monitoring the web and social media provides opportunities to observe AEs that may be related to the use of COVID-19 vaccines. The presented analysis demonstrates the ability to use web content and social media as a data source that could contribute to the early observation of AEs and enhance postmarketing surveillance. It could help to adjust signal detection strategies and communication with external stakeholders, contributing to increased confidence in vaccine safety monitoring. %M 39705077 %R 10.2196/53424 %U https://infodemiology.jmir.org/2024/1/e53424 %U https://doi.org/10.2196/53424 %U http://www.ncbi.nlm.nih.gov/pubmed/39705077 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e51567 %T Early Attrition Prediction for Web-Based Interpretation Bias Modification to Reduce Anxious Thinking: A Machine Learning Study %A Baee,Sonia %A Eberle,Jeremy W %A Baglione,Anna N %A Spears,Tyler %A Lewis,Elijah %A Wang,Hongning %A Funk,Daniel H %A Teachman,Bethany %A E Barnes,Laura %+ Department of Systems and Information Engineering, University of Virginia, 151 Engineer’s Way, Charlottesville, VA, 22904, United States, 1 434 924 1723, lb3dp@virginia.edu %K digital mental health intervention %K attrition prediction %K user engagement %K cognitive bias modification %K CBM-I %K dropout rate %K personalization %D 2024 %7 20.12.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Digital mental health is a promising paradigm for individualized, patient-driven health care. For example, cognitive bias modification programs that target interpretation biases (cognitive bias modification for interpretation [CBM-I]) can provide practice thinking about ambiguous situations in less threatening ways on the web without requiring a therapist. However, digital mental health interventions, including CBM-I, are often plagued with lack of sustained engagement and high attrition rates. New attrition detection and mitigation strategies are needed to improve these interventions. Objective: This paper aims to identify participants at a high risk of dropout during the early stages of 3 web-based trials of multisession CBM-I and to investigate which self-reported and passively detected feature sets computed from the participants interacting with the intervention and assessments were most informative in making this prediction. Methods: The participants analyzed in this paper were community adults with traits such as anxiety or negative thinking about the future (Study 1: n=252, Study 2: n=326, Study 3: n=699) who had been assigned to CBM-I conditions in 3 efficacy-effectiveness trials on our team’s public research website. To identify participants at a high risk of dropout, we created 4 unique feature sets: self-reported baseline user characteristics (eg, demographics), self-reported user context and reactions to the program (eg, state affect), self-reported user clinical functioning (eg, mental health symptoms), and passively detected user behavior on the website (eg, time spent on a web page of CBM-I training exercises, time of day during which the exercises were completed, latency of completing the assessments, and type of device used). Then, we investigated the feature sets as potential predictors of which participants were at high risk of not starting the second training session of a given program using well-known machine learning algorithms. Results: The extreme gradient boosting algorithm performed the best and identified participants at high risk with macro–F1-scores of .832 (Study 1 with 146 features), .770 (Study 2 with 87 features), and .917 (Study 3 with 127 features). Features involving passive detection of user behavior contributed the most to the prediction relative to other features. The mean Gini importance scores for the passive features were as follows: .033 (95% CI .019-.047) in Study 1; .029 (95% CI .023-.035) in Study 2; and .045 (95% CI .039-.051) in Study 3. However, using all features extracted from a given study led to the best predictive performance. Conclusions: These results suggest that using passive indicators of user behavior, alongside self-reported measures, can improve the accuracy of prediction of participants at a high risk of dropout early during multisession CBM-I programs. Furthermore, our analyses highlight the challenge of generalizability in digital health intervention studies and the need for more personalized attrition prevention strategies. %M 39705068 %R 10.2196/51567 %U https://mental.jmir.org/2024/1/e51567 %U https://doi.org/10.2196/51567 %U http://www.ncbi.nlm.nih.gov/pubmed/39705068 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53187 %T Methodological Challenges in Randomized Controlled Trials of mHealth Interventions: Cross-Sectional Survey Study and Consensus-Based Recommendations %A Lopez-Alcalde,Jesus %A Wieland,L Susan %A Yan,Yuqian %A Barth,Jürgen %A Khami,Mohammad Reza %A Shivalli,Siddharudha %A Lokker,Cynthia %A Rai,Harleen Kaur %A Macharia,Paul %A Yun,Sergi %A Lang,Elvira %A Bwanika Naggirinya,Agnes %A Campos-Asensio,Concepción %A Ahmadian,Leila %A Witt,Claudia M %+ Institute for Complementary and Integrative Medicine, University Hospital Zurich, Sonneggstrasse 6, Zurich, CH-8091, Switzerland, 41 43 253 21 31, jesus.lopez@usz.ch %K digital health %K eHealth %K mobile health %K mHealth %K randomized controlled trial %K survey %K recommendations %K intervention integrity %K adherence %K consensus %K mobile phone %D 2024 %7 19.12.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Mobile health (mHealth) refers to using mobile communication devices such as smartphones to support health, health care, and public health. mHealth interventions have their own nature and characteristics that distinguish them from traditional health care interventions, including drug interventions. Thus, randomized controlled trials (RCTs) of mHealth interventions present specific methodological challenges. Identifying and overcoming those challenges is essential to determine whether mHealth interventions improve health outcomes. Objective: We aimed to identify specific methodological challenges in RCTs testing mHealth interventions’ effects and develop consensus-based recommendations to address selected challenges. Methods: A 2-phase participatory research project was conducted. First, we sent a web-based survey to authors of mHealth RCTs. Survey respondents rated on a 5-point scale how challenging they found 21 methodological aspects in mHealth RCTs compared to non-mHealth RCTs. Nonsystematic searches until June 2022 informed the selection of the methodological challenges listed in the survey. Second, a subset of survey respondents participated in an online workshop to discuss recommendations to address selected methodological aspects identified in the survey. Finally, consensus-based recommendations were developed based on the workshop discussion and email interaction. Results: We contacted 1535 authors of mHealth intervention RCTs, of whom 80 (5.21%) completed the survey. Most respondents (74/80, 92%) identified at least one methodological aspect as more or much more challenging in mHealth RCTs. The aspects most frequently reported as more or much more challenging were those related to mHealth intervention integrity, that is, the degree to which the study intervention was implemented as intended, in particular managing low adherence to the mHealth intervention (43/77, 56%), defining adherence (39/79, 49%), measuring adherence (33/78, 42%), and determining which mHealth intervention components are used or received by the participant (31/75, 41%). Other challenges were also frequent, such as analyzing passive data (eg, data collected from smartphone sensors; 24/58, 41%) and verifying the participants’ identity during recruitment (28/68, 41%). In total, 11 survey respondents participated in the subsequent workshop (n=8, 73% had been involved in at least 2 mHealth RCTs). We developed 17 consensus-based recommendations related to the following four categories: (1) how to measure adherence to the mHealth intervention (7 recommendations), (2) defining adequate adherence (2 recommendations), (3) dealing with low adherence rates (3 recommendations), and (4) addressing mHealth intervention components (5 recommendations). Conclusions: RCTs of mHealth interventions have specific methodological challenges compared to those of non-mHealth interventions, particularly those related to intervention integrity. Following our recommendations for addressing these challenges can lead to more reliable assessments of the effects of mHealth interventions on health outcomes. %M 39700488 %R 10.2196/53187 %U https://www.jmir.org/2024/1/e53187 %U https://doi.org/10.2196/53187 %U http://www.ncbi.nlm.nih.gov/pubmed/39700488 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e55450 %T Service Attributes and Acceptability of Digital and Nondigital Depression Management Methods Among Individuals With Depressive Symptoms: Survey Study %A Auyeung,Larry %A Mak,Winnie W S %A Tsang,Ella Zoe %+ Department of Psychology, The Chinese University of Hong Kong, Shatin, NT, Hong Kong SAR, China (Hong Kong), 852 31906792, larryauyeung@link.cuhk.edu.hk %K eHealth %K acceptability %K user preference %K diffusion of innovation %K mental health services %D 2024 %7 19.12.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Academic research on digital mental health tends to focus on its efficacy and effectiveness, with much less attention paid to user preferences and experiences in real-world settings. Objective: This study aims to analyze service characteristics that service users value and compare the extent to which various digital and nondigital mental health treatments and management methods fulfill users’ expectations. Methods: A total of 114 people with at least moderate levels of depressive symptoms (as measured by Patient Health Questionnaire–9 score ≥10) completed a web-based questionnaire measuring their awareness and adoption of digital mental health services and their valuation of 15 psychological service attributes, including effectiveness, credibility, waiting time, and more. They were also assessed on their expectations toward seven common mental health treatments and management methods, including (1) face-to-face psychological intervention, (2) medication, (3) guided internet-based psychological intervention, (4) face-to-face counseling service, (5) self-guided mental health apps for depression, (6) self-help bibliotherapy, and (7) psychological intervention via videoconferencing. Results: A Friedman test with a Dunn posttest showed the average importance rank of “effectiveness” was significantly higher than all other measured attributes. “Privacy,” “credibility,” and “cost” were ranked as equally important. Participants rated face-to-face psychological intervention the most effective management method, while other digital management methods were perceived as less effective. Medication was perceived as the least appealing method, while other methods were deemed equally appealing. Face-to-face psychological intervention, medication, and counseling were considered less satisfactory due to their higher costs and longer waiting times when compared to digital services. Repeated measures ANOVA showed some forms of management method were more likely to be adopted, including guided internet-based psychological intervention, psychological intervention via videoconferencing, face-to-face psychological intervention, and face-to-face counseling services provided by a counselor as compared to self-guided mobile apps, self-help bibliotherapy, and medication. Conclusions: The study highlights the importance of considering multiple service attributes beyond effectiveness in depression management methods, despite effectiveness being regarded as the most crucial factor using the rank method. Compared to nondigital services, digital services were identified as having specific strengths as perceived by users. Future dissemination and promotion efforts may focus on debunking myths of guided internet-based psychological intervention as a less effective option and promoting the particular service strengths of digital services. %M 39699956 %R 10.2196/55450 %U https://formative.jmir.org/2024/1/e55450 %U https://doi.org/10.2196/55450 %U http://www.ncbi.nlm.nih.gov/pubmed/39699956 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e60504 %T Improving Participant Recruitment in Clinical Trials: Comparative Analysis of Innovative Digital Platforms %A Bikou,Alexia Georgia %A Deligianni,Elena %A Dermiki-Gkana,Foteini %A Liappas,Nikolaos %A Teriús-Padrón,José Gabriel %A Beltrán Jaunsarás,Maria Eugenia %A Cabrera-Umpiérrez,Maria Fernanda %A Kontogiorgis,Christos %+ Department of Medicine, Democritus University of Thrace, 6th kilometer Dragana, Alexandroupolis, 68100, Greece, 30 2551030601, ckontogi@med.duth.gr %K clinical research %K e-recruitment %K patient matching %K clinical trials %K digital platforms %K enrollment %K electronic consent %D 2024 %7 18.12.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Pharmaceutical product development relies on thorough and costly clinical trials. Participant recruitment and monitoring can be challenging. The incorporation of cutting-edge technologies such as blockchain and artificial intelligence has revolutionized clinical research (particularly in the recruitment stage), enhanced secure data storage and analysis, and facilitated participant monitoring while protecting their personal information. Objective: This study aims to investigate the use of novel digital platforms and their features, such as e-recruitment, e-consent, and matching, aiming to optimize and expedite clinical research. Methods: A review with a systematic approach was conducted encompassing literature from January 2000 to October 2024. The MEDLINE, ScienceDirect, Scopus, and Google Scholar databases were examined thoroughly using a customized search string. Inclusion criteria focused on digital platforms involving clinical trial recruitment phases that were in English and had international presence, scientific validation, regulatory approval, and no geographic limitations. Literature reviews and unvalidated digital platforms were excluded. The selected studies underwent meticulous screening by the research team, ensuring a thorough analysis of novel digital platforms and their use and features for clinical trials. Results: A total of 24 digital platforms were identified that supported clinical trial recruitment phases. In general, most of them (n=22, 80%) are headquartered and operating in the United States, providing a range of functionalities including electronic consent (n=14, 60% of the platforms), participant matching, and monitoring of patients’ health status. These supplementary features enhance the overall effectiveness of the platforms in facilitating the recruitment process for clinical trials. The analysis and digital platform findings refer to a specific time frame when the investigation took place, and a notable surge was observed in the adoption of these novel digital tools, particularly following the COVID-19 outbreak. Conclusions: This study underscores the vital role of the identified digital platforms in clinical trials, aiding in recruitment, enhancing patient engagement, accelerating procedures, and personalizing vital sign monitoring. Despite their impact, challenges in accessibility, compatibility, and transparency require careful consideration. Addressing these challenges is crucial for optimizing digital tool integration into clinical research, allowing researchers to harness the benefits while managing the associated risks effectively. %M 39693619 %R 10.2196/60504 %U https://www.jmir.org/2024/1/e60504 %U https://doi.org/10.2196/60504 %U http://www.ncbi.nlm.nih.gov/pubmed/39693619 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e63680 %T Exploring Individuals’ Views and Feedback on a Nutritional Screening Mobile App: Qualitative Focus Group Study %A Jones,Debra %A Sowerbutts,Anne Marie %A Burden,Sorrel %+ School of Health Sciences, University of Manchester, Jean McFarlane Building, 5th Floor, Oxford Road, Manchester, M13 9PL, United Kingdom, 44 1613061508, debra.jones@manchester.ac.uk %K malnutrition %K malnutrition risk %K malnutrition screening %K MUST %K mobile application %K mHealth app %K malnutrition universal screening tool %D 2024 %7 18.12.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Malnutrition is a major global health challenge. Worldwide, approximately 390 million adults are underweight, while 2.5 billion are overweight. The Malnutrition Universal Screening Tool (MUST) has been implemented successfully in the United Kingdom to assess the nutritional status of patients in health care settings. Currently, MUST is available as a web-based tool or as a paper-based version, However, the paper tool can lead to calculation errors, and web-based tools require internet access, limiting use in some communities. The MUST app uses clear and simple navigation and processes information precisely, so could potentially improve the accuracy and accessibility of malnutrition screening for health care professionals (HCP) in all settings. Objective: This study aimed to explore the views of HCPs on the content, functionality, and usability of a newly developed mobile app for MUST. Methods: We performed a qualitative study using deductive and inductive framework analysis. A series of online focus groups (~1 hour each) were conducted, exploring potential users’ views on the app’s content design, functionality, and usefulness, which was set in demonstration mode and not available for direct use with patients. Each focus group used a semistructured approach and predefined topic guide. Participants were recruited consecutively and United Kingdom–wide using advertisements through emails, newsletters, and on social media across appropriate local and national networks. Participants had the opportunity to look at the app on their phones before giving feedback and an on-screen demonstration of the app was provided during the focus group. Data were analyzed using deductive and inductive framework analysis. Results: In total, 8 online focus groups were conducted between August 2022 and January 2023. Participants (n=32) were dietetic and nutrition HCPs or educators with experience in using MUST in clinical or community settings. Data analysis revealed three broad themes: (1) improving the app for better use in practice, (2) user experience of design, and (3) barriers and facilitators in different settings. Overall feedback for the app was positive with potential users considering it to be very useful for improving routine and accurate screening, particularly in the community, and mainly because of the automatic calculation feature, which may help with improving discrepancies. Participants generally considered the app to be for professional use only, stating that patients may find it too clinical or technical. Participants also made suggestions for app sustainability and improvements, such as incentives to complete the demographics section or the option to skip questions, and the addition of more subjective measures and instructions on measuring ulna length. Conclusions: The MUST app was positively evaluated by potential users, who reported it was user-friendly and an accessible way to screen for malnutrition risk, whilst improving the accuracy of screening and availability in community settings. %M 39693128 %R 10.2196/63680 %U https://formative.jmir.org/2024/1/e63680 %U https://doi.org/10.2196/63680 %U http://www.ncbi.nlm.nih.gov/pubmed/39693128 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e60879 %T A Digital Approach for Addressing Suicidal Ideation and Behaviors in Youth Mental Health Services: Observational Study %A Chong,Min K %A Hickie,Ian B %A Ottavio,Antonia %A Rogers,David %A Dimitropoulos,Gina %A LaMonica,Haley M %A Borgnolo,Luke J %A McKenna,Sarah %A Scott,Elizabeth M %A Iorfino,Frank %+ Brain and Mind Centre, The University of Sydney, 94 Mallett Street, Camperdown, 2050, Australia, 61 (02) 9114 2199, min.chong@sydney.edu.au %K mental health service %K youth mental health %K suicide management %K clinical decision support %K primary care %K personalization %K suicide %K suicidal %K youth %K mental health %K mental health care %K suicide prevention %K digital technology %K online assessment %K clinician %K digital health %K health informatics %K clinical information %D 2024 %7 18.12.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Long wait times for mental health treatments may cause delays in early detection and management of suicidal ideation and behaviors, which are crucial for effective mental health care and suicide prevention. The use of digital technology is a potential solution for prompt identification of youth with high suicidality. Objective: The primary aim of this study was to evaluate the use of a digital suicidality notification system designed to detect and respond to suicidal needs in youth mental health services. Second, the study aimed to characterize young people at different levels of suicidal ideation and behaviors. Methods: Young people aged between 16 and 25 years completed multidimensional assessments using a digital platform, collecting demographic, clinical, social, functional, and suicidality information. When the suicidality score exceeded a predetermined threshold, established based on clinical expertise and service policies, a rule-based algorithm configured within the platform immediately generated an alert for treating clinicians. Subsequent clinical actions and response times were analyzed. Results: A total of 2021 individuals participated, of whom 266 (11%) triggered one or more high suicidal ideation and behaviors notification. Of the 292 notifications generated, 76% (222/292) were resolved, with a median response time of 1.9 (range 0-50.8) days. Clinical actions initiated to address suicidality included creating safety plans (60%, 134/222), conducting safety checks (18%, 39/222), psychological therapy (8%, 17/222), transfer to another service (3%, 8/222), and scheduling of new appointments (2%, 4/222). Young people with high levels of suicidality were more likely to present with more severe and comorbid symptoms, including low engagement in work or education, heterogenous psychopathology, substance misuse, and recurrent illness. Conclusions: The digital suicidality notification system facilitated prompt clinical actions by alerting clinicians to high levels of suicidal ideation and behaviors detected among youth. Further, the multidimensional assessment revealed complex and comorbid symptoms exhibited in youth with high suicidality. By expediting and personalizing care for those displaying elevated suicidality, the digital notification system can play a pivotal role in preventing rapid symptom progression and its detrimental impacts on young people’s mental health. %M 39693140 %R 10.2196/60879 %U https://www.jmir.org/2024/1/e60879 %U https://doi.org/10.2196/60879 %U http://www.ncbi.nlm.nih.gov/pubmed/39693140 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e59093 %T Effectiveness of an Internet-Based Acceptance and Commitment Therapy Intervention for Reducing Psychological Distress in Health Care Professionals: Randomized Controlled Trial %A Zhang,Lin %A Huang,Shuang %A Liu,Sha %A Huang,Yuanxiu %A Chen,Shan %A Hu,Jinsong %A Xu,Mingzhong %+ Changsha Municipal Center for Disease Control and Prevention, 509 Wanjiali North Road, Changsha, 410004, China, 86 13873184830, cscdcbm@126.com %K acceptance and commitment therapy %K internet-based intervention %K stress %K anxiety %K depression %K burnout %K health care professionals %K randomized controlled trial %D 2024 %7 18.12.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Psychological distress is prevalent among health care professionals and can lead to poor-quality patient care. Internet-based acceptance and commitment therapy (iACT) is a promising intervention for improving mental health due to its low cost and easy access. However, there is limited evidence of its effectiveness in reducing health care professionals’ psychological distress. Objective: This study aims to examine the effects of iACT on psychological distress (stress, anxiety, and depression) among health care professionals in China. Methods: From October 2022 to February 2023, a total of 108 health care professionals were recruited via WeChat and randomized into a 6-week iACT intervention program with therapist support (n=54) or waitlist control group (n=54). The intervention included 21 self-guided sessions combining teaching videos, mindfulness practices, and journal writing, followed by 7 live conferences to share experiences and discuss questions, all conducted via WeChat. Primary outcomes (stress, anxiety, and depression) and secondary outcomes (burnout and psychological flexibility) were collected using the Sojump platform, the most popular web-based survey platform in China. Generalized estimating equations were used to compare the outcomes between groups and assess the effects of group, time, and group-by-time interaction. Subgroup and sensitive analyses were performed to test the robustness of our findings across various groups. Results: Among the 108 health care professionals, 68 (63%) completed the follow-up assessment at week 10, including 35 (64.8%) in the iACT group and 33 (61.1%) in the waitlist control group. Of the 54 participants in the iACT group, all attended at least 2 sessions, and 25 attended all 28 sessions. On average, participants attended 20 (71%) sessions. The iACT group showed significant improvement in the Depression Anxiety and Stress Scales-21 total score (d=0.82, 95% CI 0.39-1.26), and the effects were sustained for 4 weeks after the intervention (d=1.08, 95% CI 0.57-1.59). Compared to the control group, the iACT group showed significantly lower scores in burnout at week 6 (d=1.42, 95% CI 0.95-1.89) and week 10 (d=1.52, 95% CI 0.98-2.06). The iACT group showed significantly higher psychological flexibility at week 6 (d=1.23, 95% CI 0.77-1.69) and week 10 (d=1.15, 95% CI 0.64-1.66). Conclusions: The iACT effectively decreased health care professionals’ psychological distress and burnout and improved their psychological flexibility. Our findings provide implications and guidance for the development and broad implementation of iACT in health care settings to improve the mental health of health care professionals. Trial Registration: Chinese Clinical Trial Register ChiCTR2400093584; https://tinyurl.com/38werwsk %M 39693127 %R 10.2196/59093 %U https://www.jmir.org/2024/1/e59093 %U https://doi.org/10.2196/59093 %U http://www.ncbi.nlm.nih.gov/pubmed/39693127 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e51566 %T Effects of a Smartphone-Based Breastfeeding Coparenting Intervention Program on Breastfeeding-Related Outcomes in Couples During First Pregnancy: Randomized Controlled Trial %A Huang,Yi-Yan %A Wang,Rong %A Huang,Wei-Peng %A Wu,Tian %A Wang,Shi-Yun %A R. Redding,Sharon %A Ouyang,Yan-Qiong %+ School of Nursing, Wuhan University, 115 Donghu Rd, Wuchang District, Wuhan, 430072, China, 86 27 68759710, ouyangyq@whu.edu.cn %K breastfeeding %K co-parenting %K randomized controlled %K child %K efficacy %K depressive symptoms %D 2024 %7 17.12.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: A low breastfeeding rate causes an increased health care burden and negative health outcomes for individuals and society. Coparenting is an essential tactic for encouraging breastfeeding when raising a child. The efficacy of the coparenting interventions in enhancing breastfeeding-related outcomes is controversial. Objective: This study aimed to examine the effects of coparenting interventions on exclusive breastfeeding rates, exclusive breastfeeding duration, breastfeeding knowledge, parenting sense of competence, coparenting relationships, depressive symptoms in new couples at 1 and 6 months post partum, and the BMI of infants 42 days post partum. Methods: This was a randomized, single-blinded controlled clinical trial. Eligible couples in late pregnancy in a hospital in central China were randomly assigned to 2 groups. While couples in the control group received general care, couples in the intervention group had access to parenting classes, a fathers’ support group, and individual counseling. Data were collected at baseline (T0), 1 month post partum (T1), and 6 months post partum (T2). Data on exclusive breastfeeding rate and exclusive breastfeeding duration were analyzed using the chi-square, Fisher exact, or Mann-Whitney U tests; coparenting relationships and the infant’s BMI were analyzed using an independent samples t test; and breastfeeding knowledge, parenting sense of competence, and depressive symptoms were analyzed using a generalized estimation equation. Results: A total of 96 couples were recruited, and 79 couples completed the study. The intervention group exhibited significantly higher exclusive breastfeeding rates at T1 (90% vs 65%, P=.02) and T2 (43.6% vs 22.5%, P=.02), compared with the control group. Exclusive breastfeeding duration was extended in the intervention group than in the control group at T1 (30, range 30-30 days vs 30, range 26.5-30 days; P=.01) and T2 (108, range 60-180 days vs 89, range 28-149.3 days; P<.05). The intervention group exhibited greater improvements in maternal breastfeeding knowledge (β=.07, 95% CI 0.006-0.13; P=.03) and maternal parenting sense of competence (β=5.49, 95% CI 2.09-8.87; P<.01) at T1, enhanced coparenting relationships at T1 (P<.001) and T2 (P=.02), paternal breastfeeding knowledge at T2 (β=.25, 95% CI 0.15-0.35, P<.001), paternal parenting sense of competence at T1 (β=5.35, 95% CI 2.23-8.47, P<.01), and reduced paternal depressive symptoms at T2 (β=.25, 95% CI 0.15-0.35, P<.001), and there was a rise in infants’ BMI at 42 days post partum (β=.33, 95% CI 0.01-0.64, P=.04). Conclusions: An evidence-based breastfeeding coparenting intervention is effective in improving exclusive breastfeeding rate, prolonging exclusive breastfeeding duration within the initial 6 months post partum, enhancing parental breastfeeding knowledge, levels of parenting sense of competence and coparenting relationship, infant’s BMI, and reducing paternal depressive symptoms. Trial Registration: Chinese Clinical Trial Registry ChiCTR2300069648; https://tinyurl.com/2p8st2p8 %M 39689308 %R 10.2196/51566 %U https://www.jmir.org/2024/1/e51566 %U https://doi.org/10.2196/51566 %U http://www.ncbi.nlm.nih.gov/pubmed/39689308 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e55429 %T Personalized Mobile App–Based Program for Preparation and Recovery After Radical Prostatectomy: Initial Evidence for Improved Outcomes From a Prospective Nonrandomized Study %A Martini,Alberto %A Kesch,Claudia %A Touzani,Alae %A Calleris,Giorgio %A Buhas,Bogdan %A Abou-Zahr,Rawad %A Rahota,Razvan-George %A Pradère,Benjamin %A Tollon,Christophe %A Beauval,Jean-Baptiste %A Ploussard,Guillaume %+ Department of Urology, La Croix du Sud Hospital, 52 Chemin De Ribaute, Quint-Fonsegrives, 31130, France, 33 56340913241, a.martini.md@gmail.com %K prehabilitation %K radical prostatectomy %K robot, outcomes %K continence %K mobile app %K app %K electronic health %K eHealth %K surgical %K human resource %K health care %K single-surgeon %K implementation %K betty.care app %K cohort %K perioperative %K rehabilitation %K mobile health %K mHealth %D 2024 %7 13.12.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: eHealth can help replicate the benefits of conventional surgical prehabilitation programs and overcome organizational constraints related to human resources and health care–related costs. Objective: We aimed to assess the impact of an optimized perioperative program using a personalized mobile app designed for preparation and recovery after radical prostatectomy (RP). Methods: We report on a series of 122 consecutive robot-assisted RP before and after the implementation of the betty.care app (cohort A: standard of care, n=60; cohort B: optimized program, n=62). The primary end point was continence recovery, defined as “0 or 1 safety pad per day” at 6 weeks after surgery. Secondary end points were length of stay, same-day discharge, complications, readmissions, and number of days alive and out of hospital within 30 days from surgery. Results: Both cohorts were comparable in terms of age, prostate-specific antigen, prostate volume, and disease aggressiveness. Intraoperative parameters (lymph node dissection, operative time, and bilateral nerve-sparing surgery) were comparable in both groups, except for blood loss, which was significantly higher in cohort B (182 vs 125 cc; P=.008). The 6-week continence rate was improved in cohort B in both univariable and multivariable analyses (92% vs 75%; P=.01). There were trends favoring cohort B for all secondary end points with a minimal 30% benefit compared with cohort A. Grade 2 or more complications occurred less frequently in cohort B (13% vs 3.2%; P=.042). Same-day discharge and readmission rates were 35% and 53% (P=.043), and 3.3% and 1.6% (P=.54) in cohorts A and B, respectively. Mean length of stay was reduced by 0.2 days in cohort B (0.58 vs 0.78 days; P=.10). The main limitation was the absence of randomization. Conclusions: The implementation of a mobile app that provides a holistic approach to the perioperative period, integrating prehabilitation, rehabilitation, and remote monitoring, could lead to the improvement of important functional outcomes after RP and could replicate an on-site prehabilitation program. Multicenter validation is needed. %M 39671590 %R 10.2196/55429 %U https://www.jmir.org/2024/1/e55429 %U https://doi.org/10.2196/55429 %U http://www.ncbi.nlm.nih.gov/pubmed/39671590 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e58920 %T Exploring and Predicting HIV Preexposure Prophylaxis Adherence Patterns Among Men Who Have Sex With Men: Randomized Controlled Longitudinal Study of an mHealth Intervention in Western China %A Lin,Bing %A Li,Jiayan %A Liu,Jiaxiu %A He,Wei %A Pan,Haiying %A Zhong,Xiaoni %K preexposure prophylaxis %K adherence %K trajectory analysis %K men who have sex with men %K mHealth %K mobile health %K mHealth intervention %K decision tree %D 2024 %7 12.12.2024 %9 %J JMIR Mhealth Uhealth %G English %X Background: Preexposure prophylaxis (PrEP) is an effective strategy to reduce the risk of HIV infection. However, the efficacy of PrEP is highly dependent on adherence. Meanwhile, adherence changes over time, making it difficult to manage effectively. Objective: Our study aimed to explore and predict the patterns of change in PrEP adherence among men who have sex with men (MSM) and evaluate the impact of the WeChat-based reminder intervention on adherence, thus providing more information for PrEP implementation strategies. Methods: From November 2019 to June 2023, in a randomized controlled longitudinal study of the PrEP demonstration project in Western China (Chongqing, Sichuan, and Xinjiang) based on a mobile health (mHealth) reminder intervention, participants were randomly divided into reminder and no-reminder groups, with those in the reminder group receiving daily reminders based on the WeChat app. Participants were followed up and self-reported their medication adherence every 12 weeks for a total of 5 follow-up visits. We used the growth mixture model (GMM) to explore potential categories and longitudinal trajectories of adherence among MSM, and patterns of change in PrEP adherence were predicted and evaluated based on the decision tree. Results: A total of 446 MSM were included in the analysis. The GMM identified 3 trajectories of adherence: intermediate adherence group (n=34, 7.62%), low adherence ascending group (n=126, 28.25%), and high adherence decline group (n=286, 64.13%). We included 8 variables that were significant in the univariate analysis in the decision tree prediction model. We found 4 factors and 8 prediction rules, and the results showed that HIV knowledge score, education attainment, mHealth intervention, and HIV testing were key nodes in the patterns of change in adherence. After 10-fold cross-validation, the final prediction model had an accuracy of 75%, and the classification accuracy of low and intermediate adherence was 78.12%. Conclusions: The WeChat-based reminder intervention was beneficial for adherence. A short set of questions and prediction rules, which can be applied in future large-scale validation studies, aimed at developing and validating a short adherence assessment tool and implementing it in PrEP practices among MSM. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900026414; https://www.chictr.org.cn/showproj.html?proj=35077 %R 10.2196/58920 %U https://mhealth.jmir.org/2024/1/e58920 %U https://doi.org/10.2196/58920 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e52542 %T Factors Associated With Digital Intervention Engagement and Adherence in Patients With Cancer: Systematic Review %A Montalescot,Lucile %A Baussard,Louise %A Charbonnier,Elodie %+ Laboratoire de Psychopathologie et Processus de Santé, Université Paris-Cité, 71 avenue Edouard Vaillant, Boulogne-Billancourt, 92100, France, 33 1 76 53 29 81, lucile.montalescot@u-paris.fr %K adherence %K engagement %K eHealth %K mHealth %K cancer %K mobile health %K app %K eHealth interventions %K patient %K cancer care %K digital health %K health-related %K intervention-related %K sociodemographic %K behavior %K systematic review %D 2024 %7 11.12.2024 %9 Review %J J Med Internet Res %G English %X Background: Digital interventions offer vital support for patients with cancer through education, behavior change, and monitoring. Despite their potential, patient adherence to and engagement with these self-help interventions is challenging. Factors like user characteristics, technology, and intervention design influence adherence and engagement. Existing reviews have gaps in exploring diverse factors associated with adherence in cancer care. Objective: This systematic review aims to identify factors influencing adherence to and engagement with digital interventions with self-help components in cancer care. It examined sociodemographic, psychosocial, health-related, and intervention-related factors that affect patients’ adherence to and engagement with these digital health solutions. Methods: Following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, a search was conducted across PubMed, Embase, Cochrane Library, and PsycINFO to find studies published from January 2010 to September 2021. The studies included in this review focused on adult patients with cancer using digital interventions with self-help features. Data were extracted and synthesized using a standardized approach. Factors associated with adherence were synthesized according to their type—sociodemographic factors, psychosocial factors, health-related factors, technology-related factors, and intervention-related factors. Results: Among 9386 studies initially screened, 61 (0.6%) were eligible for analysis. These studies covered diverse eHealth intervention types, cancer types, and outcome measures. Investigating the determinants of adherence to and engagement with digital interventions was the main objective for 43% (26/61) of the included studies. Adherence and engagement were gauged using varied measures, such as dropout rates, log-ins, and self-reported measures. Results regarding factors associated with adherence and engagement were inconsistent across studies. Most sociodemographic (eg, age) and health-related factors (eg, cancer stage) yielded mixed outcomes. However, comorbidity consistently predicted lower adherence and engagement. Results regarding psychosocial factors were more stable across studies. Specifically, higher social support was associated with lower adherence and engagement. Finally, intervention-related factors like intervention type or human support showed conflicting results. Adopting an intersectional perspective revealed that specificities vary according to intervention goals and the operationalization of adherence versus engagement, with women being more adherent and engaged than men in interventions targeting distress. When focusing on adherence rather than engagement, older patients were more adherent than younger patients. Conclusions: This review highlights the complexity of adherence to and engagement with digital interventions in cancer care. While some factors, notably comorbidities and low social support, were consistently linked to adherence and engagement, others displayed mixed associations. The review underscores the need for standardizing measures, investigating specific intervention features, and enhancing study quality to optimize digital interventions for patients with cancer. Further research is crucial to better understand and improve adherence to digital health solutions in cancer care. Trial Registration: PROSPERO CRD42021281028; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=281028 %R 10.2196/52542 %U https://www.jmir.org/2024/1/e52542 %U https://doi.org/10.2196/52542 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e54636 %T Psychological Factors That Contribute to the Use of Video Consultations in Health Care: Systematic Review %A Haydon,Helen M %A Fowler,James A %A Taylor,Monica L %A Smith,Anthony C %A Caffery,Liam J %+ Centre for Online Health, The University of Queensland, Ground Floor, Building 33, Princess Alexandra Hospital, Woolloongabba, 4102, Australia, 61 7 3176 4462, h.haydon@uq.edu.au %K telehealth %K video consultations %K psychological factors %K health professionals %K health services research %K psychological %K video %K systematic review %K review %K barriers %K engagement %K health services %K cognitive %K consultations %K psychological barrier %D 2024 %7 11.12.2024 %9 Review %J J Med Internet Res %G English %X Background: There are numerous benefits to delivering care via video consultations (VCs). Yet, the willingness of health care professionals (HCPs) to use video as a modality of care is one of the greatest barriers to its adoption. Decisions regarding whether to use video may be based on assumptions and concerns that are not necessarily borne of evidence. To effectively address psychological barriers to VC, it is essential to gain a better understanding of specific factors (eg, attitudes, beliefs, and emotions) that influence HCPs’ VC use. Objective: This study’s aim was to conduct a systematic literature review of psychological factors in HCPs that impair or promote VC use. Methods: Databases were searched in February 2023 for peer-reviewed primary research papers on VCs that discussed psychological factors of health professionals affecting the use of video to deliver health services. A psychological factor was defined as an intraindividual influence related to, or in reaction to, VC use—in this case, the individual being an HCP. Search terms included variations on “telehealth,” “clinician,” and psychological factors (eg, attitude and beliefs) in combination. Peer-reviewed papers of all methodological approaches were included if they were in an Australian setting and the full text was available in English. Studies where the main intervention was another digital health modality (eg, remote monitoring and telephone) were excluded. Studies were also excluded if they only reported on extrinsic factors (eg, environmental or economic). Information extracted included author, year, medical specialty, psychological component mentioned, explanation as to why the psychological factor was related to VC use, and exemplar quotes from the paper that correspond to a psychological component. Each extracted psychological factor was classified as a positive, negative, ambivalent, or neutral perspective on VC, and a thematic analysis then generated the factors and themes. Theories of behavior were considered and discussed to help frame the interaction between themes. Results: From 4592 studies, data were extracted from 90 peer-reviewed papers. Cognitive and emotional motivators and inhibitors, such as emotional responses, self-efficacy, attitudes, and perceived impact on the clinician as a professional, all interact to influence HCP engagement in VCs. These factors were complex and impacted upon one another. A cyclical relationship between these factors and intention to engage in VCs and actual use of VCs was found. These findings were used to form the psychological attributes of VC engagement (PAVE) model. Evidence suggests that HCPs fall within 4 key user categories based on the amount of cognitive and practical effort needed to deliver VCs. Conclusions: Although further research is needed to validate the current findings, this study provides opportunity for more targeted interventions that address psychological factors impeding effective use of VCs. %M 39661977 %R 10.2196/54636 %U https://www.jmir.org/2024/1/e54636 %U https://doi.org/10.2196/54636 %U http://www.ncbi.nlm.nih.gov/pubmed/39661977 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e57960 %T Results of a Digital Multimodal Motivational and Educational Program as Follow-Up Care for Former Cardiac Rehabilitation Patients: Randomized Controlled Trial %A Bretschneider,Maxi Pia %A Mayer-Berger,Wolfgang %A Weine,Jens %A Roth,Lena %A Schwarz,Peter E H %A Petermann,Franz %K mHealth %K apps %K digital technology %K digital interventions %K coronary heart disease %K lifestyle intervention %K cardiac rehabilitation %K quality of life %K cardiac care %D 2024 %7 11.12.2024 %9 %J JMIR Cardio %G English %X Background: Digital interventions are promising additions for both usual care and rehabilitation. Evidence and studies for the latter, however, are still rare. Objective: The aim of the study was to examine the app/web-based patient education program called “mebix” (previously called “Vision 2 – Gesundes Herz”) regarding its effectiveness in relation to the parameters of disease-specific quality of life (HeartQoL), cardiovascular risk profile (Cardiovascular Risk Management [CARRISMA]), and prognostic estimation of early retirement (Screening instrument work and occupation [SIBAR]) in 190 participants from a cardiological rehabilitation clinic. Methods: To evaluate mebix, 354 patients from the Roderbirken Clinic of the German Pension Insurance Rhineland (Germany) with a coronary heart diesase were recruited and randomized either to the intervention group (using mebix postrehabiliation for up to 12 months) or the control group (receiving standard care). The data collection took place at the end of inpatient rehabilitation (t0), as well as 6 months (t1) and 12 months (t2) after the end of rehabilitation. Analyses of variance are used to assess the overall significance of difference in outcome parameters between groups and over time. Results: The primary endpoint of disease-related quality of life shows a significant improvement of 7.35 points over the course of the intervention that is also more pronounced in the intervention group. Similarly, the 10-year risk of cardiovascular death and myocardial infarction showed significant improvements in the cardiovascular risk profile over time and between groups, indicating better results in the intervention group (ie, a reduction of −1.59 and −5.03, respectively). Secondary outcomes like the body weight and cholesterol levels were significantly reduced in the intervention group, also in comparison with the control group. In addition, the SIBAR was significantly lower/better at the end of the observation period than at the beginning of the observation for both groups. Conclusions: Overall, the digital training program represents an effective follow-up offer after rehabilitation that could be incorporated into standard care to further improve disease-related quality of life and cardiovascular risk profiles. Trial Registration: German Clinical Trials Register DRKS00007569; https://drks.de/search/en/trial/DRKS00007569 %R 10.2196/57960 %U https://cardio.jmir.org/2024/1/e57960 %U https://doi.org/10.2196/57960 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e54678 %T Targeting Daily Positive Events to Improve Emotional and Functional Well-Being in Adults With Fibromyalgia: Insights From the LARKSPUR Randomized Controlled Trial %A Ong,Anthony %A Wilcox,Kenneth %A Reid,M Carrington %A Wethington,Elaine %A Cintron,Dakota %A Addington,Elizabeth %A Goktas,Selin %A Moskowitz,Judith %+ Department of Psychology, Cornell University, G421 Martha Van Rensselaer Hall, Cornell University, Ithaca, NY, 14850, United States, 1 6072294119, anthony.ong@cornell.edu %K positive affect %K chronic pain %K chronic condition %K long-term pain %K positive psychology %K positive events %K fibromyalgia %K mHealth %K app %K digital technology %K digital interventions %K gerontology %K geriatrics %K older adult %K aging %K well-being %D 2024 %7 10.12.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Fibromyalgia is a chronic pain condition characterized by widespread musculoskeletal pain, fatigue, and cognitive difficulties, affecting individuals across all age groups. Positive affect (PA) interventions have shown promise in enhancing emotional well-being and pain management in patients with diverse chronic pain conditions. However, the efficacy of internet-delivered PA interventions for individuals with fibromyalgia remains understudied. Objective: This randomized controlled trial investigated the efficacy of a web-based PA regulation intervention—Lessons in Affect Regulation to Keep Stress and Pain Under Control (LARKSPUR)—in enhancing emotional and functional well-being among adults with fibromyalgia syndrome. Methods: A total of 95 participants with fibromyalgia syndrome aged 50 years and older (89/95, 94% female) were randomized to one of two fully automated conditions: (1) LARKSPUR (n=49) or (2) emotion reporting/attention control (n=46). At the postintervention and 1-month follow-up time points, participants completed 7 consecutive, end-of-day, web-based reports capturing positive events (PE), pain, fatigue, PA, and negative affect. Results: Compared to control, LARKSPUR resulted in greater improvements in daily affective responsivity to PE at the postintervention time point, including greater reductions in negative affect (bL–bC=–0.06, 95% highest posterior density interval [HPD] –0.10 to –0.02) and increases in PA (bL–bC=0.10, 95% HPD 0.02-0.19). Furthermore, across the postintervention and 1-month follow-up time points, LARKSPUR led to greater reductions in pain (bL–bC=–0.20, 95% HPD –0.36 to –0.04) and fatigue (bL–bC=–0.24, 95% HPD –0.41 to –0.06) following PE. Conclusions: This randomized controlled trial provides initial evidence that a web-based PA skills intervention can enhance emotional well-being and reduce pain and fatigue in aging adults with fibromyalgia. Trial Registration: ClinicalTrials.gov NCT04869345; https://clinicaltrials.gov/study/NCT04869345 %M 39657168 %R 10.2196/54678 %U https://www.jmir.org/2024/1/e54678 %U https://doi.org/10.2196/54678 %U http://www.ncbi.nlm.nih.gov/pubmed/39657168 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e63078 %T Feasibility and Efficacy of a Novel Mindfulness App Used With Matcha Green Tea in Generally Healthy Adults: Randomized Controlled Trial %A Tanaka-Kanegae,Ryohei %A Yamada,Koji %A Cook,Chad M %A Blonquist,Traci M %A Taggart,Kristen D %A Hamada,Koichiro %+ Saga Nutraceuticals Research Institute, Otsuka Pharmaceutical Co Ltd, 5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho, Kanzaki-gun, Saga, 842-0195, Japan, 81 952521522, tanaka.ryohei@otsuka.jp %K mindfulness %K guided tea meditation %K meditation %K matcha %K green tea %K mobile app %K smartphone %K stress %K mood %K mHealth %K mobile health %K well-being %K wellness %D 2024 %7 10.12.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mindfulness practices, such as breathing meditation (BM), reduce stress and enhance mood. One such practice is mindful eating, where a practitioner focuses on the five senses while eating or drinking. A novel set of prototypes has been developed, incorporating principles of mindful eating. These prototypes include matcha green tea and a mobile app that provides audio guidance for meditation during the preparation and consumption of the beverage (hereafter referred to as guided tea meditation [GTM]). Objective: This study assessed the feasibility and efficacy of GTM, evaluating meditation time, frequency, and prototype acceptability over 8 weeks, alongside changes in stress and mood. Additionally, other benefits of GTM were explored. Methods: A comparator group was established in which participants performed traditional BM without an app or audio guide (active control). This unblinded randomized controlled trial involved 100 healthy American volunteers (n=49 GTM, n=51 BM). During the 8-week study period, participants were encouraged to perform either GTM or BM for 10 minutes daily. The meditation activity was self-reported the following day. Only the GTM group assessed the prototype acceptability. The Perceived Stress Scale-10 was used to measure stress levels, while the Two-Dimensional Mood Scale was used to evaluate mood changes. Other meditation benefits were explored using a questionnaire. All questionnaires were presented and completed via an app. An intention-to-treat analysis was performed. Results: No significant between-group differences were found in total meditation time (P=.15) or frequency (P=.36). However, the weekly time and frequency of the GTM group remained above 50 minutes per week and 4 days per week, respectively. Over half of the GTM participants (≥28/49, ≥57%) accepted the prototype. The GTM group exhibited significant stress reductions at weeks 4 and 8 (both P<.001), similar to the BM group. Improvements in mood metrics were observed after a single GTM session on days 1 and 56, similar to the BM group. Moreover, increases in premeditation scores for relaxed and calm from day 1 to day 56 were significantly higher for the GTM group (P=.04 and .048, respectively). The majority of participants (≥25/49, ≥51%) assigned to GTM experienced positive changes in happiness, time management, quality of life, relationships, sleep, and work performance as they continued meditating. However, no significant between-group differences were found in these exploratory outcomes (P>.08). Conclusions: We believe that GTM exhibits good feasibility. Meanwhile, GTM reduced stress, improved mood, and let the practitioners feel other benefits, similar to BM. Long-term practitioners of GTM may even feel more relaxed and calmer in the state of premeditation than those who practice BM. Trial Registration: ClinicalTrials.gov NCT05832645; https://clinicaltrials.gov/study/NCT05832645 %M 39657179 %R 10.2196/63078 %U https://mhealth.jmir.org/2024/1/e63078 %U https://doi.org/10.2196/63078 %U http://www.ncbi.nlm.nih.gov/pubmed/39657179 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e50041 %T Tracked Physical Activity Levels Before and After a Change in Incentive Strategy Among UK Adults Using a Rewards App: Retrospective Quasi-Experimental Study %A McCarthy,Hannah %A Potts,Henry W W %A Fisher,Abigail %+ University College London, Gower Street, London, WC1E 6BT, United Kingdom, 44 20 7679 2000, h.potts@ucl.ac.uk %K mHealth %K rewards %K incentives %K physical activity %K smartphone %K apps %K mobile apps %K app-based intervention %K behavior change %K exercise %D 2024 %7 10.12.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Financial incentives delivered via apps appear to be effective in encouraging physical activity. However, the literature on different incentive strategies is limited, and the question remains whether financial incentives offer a cost-effective intervention that could be funded at the population level. Objective: This study aimed to explore patterns of tracked physical activity by users of an incentive-based app before and after a change in incentive strategy. A business decision to alter the incentives in a commercially available app offered a natural experiment to explore GPS-tracked data in a retrospective, quasi-experimental study. The purpose of this exploratory analysis was to inform the design of future controlled trials of incentives delivered via an app to optimize their usability and cost-effectiveness. Methods: Weekly minutes of tracked physical activity were explored among a sample of 1666 participants. A Friedman test was used to determine differences in physical activity before and after the change in incentive strategies. Post hoc Wilcoxon tests were used to assess minutes of physical activity in the 2 weeks before and after the change. A secondary analysis explored longitudinal patterns of physical activity by plotting the mean and median minutes of physical activity from 17 weeks before and 13 weeks after the change in incentive strategy. CIs were calculated using bias-corrected bootstraps. Demographics were also explored in this way. Results: There were significant differences in the weekly minutes of activity before and after the change in incentive strategy (Friedman χ22=42, P<.001). However, a longitudinal view of the data showed a more complex and marked variation in activity over time that undermined the conclusions of the before/after analysis. Conclusions: Short-term before-and-after observational studies of app-tracked physical activity may result in misleading conclusions about the effectiveness of incentive strategies. Longitudinal views of the data show that important fluctuations are occurring over time. Future studies of app-tracked physical activity should explore such variations by using longitudinal analyses and accounting for possible moderating variables to better understand what an effective incentive might be, for whom, and at what cost. %M 39657165 %R 10.2196/50041 %U https://formative.jmir.org/2024/1/e50041 %U https://doi.org/10.2196/50041 %U http://www.ncbi.nlm.nih.gov/pubmed/39657165 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e55243 %T Effects of 10 Weeks of Walking With Mobile Step-Tracking Apps on Body Composition, Fitness, and Psychological State in Adolescents Who Are Overweight and Obese: Randomized Controlled Trial %A Mateo-Orcajada,Adrián %A Ponce-Ramírez,Cristina M %A Abenza-Cano,Lucía %A Vaquero-Cristóbal,Raquel %+ Facultad de Deporte, Universidad Católica de Murcia (UCAM), Avenida de los Jerónimos, Murcia, 30107, Spain, 34 968 278 824, labenza@ucam.edu %K adolescents %K obesity %K physical activity %K overweight %K mobile app %K physical education %D 2024 %7 10.12.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: In recent decades, physical activity intervention programs have been developed to reduce overweight and obesity in adolescents. However, this population is considered hard to reach in physical activity programs due to lack of adherence and poor results. Interventions with mobile phones in the adolescent population with normal weight have shown benefits, so this line of research may provide benefits in adolescents with overweight or obesity, although it has not yet been explored in the scientific literature. Objective: This study aims to determine the changes produced by a 10-week intervention promoted during school lessons on physical education using step tracker mobile apps in out-of-school hours on physical activity, adherence to the Mediterranean diet, body composition, and the physical condition of adolescents who are overweight and obese, and to analyze the changes achieved by the 10-week intervention on the psychological state of adolescents who are overweight and obese. Methods: The study was based on a randomized controlled trial with an initial sample of 50 adolescents aged between 12 and 16 years (from the first to the fourth years of compulsory secondary education), whose body composition, physical activity level, physical condition, and psychological state were measured. Participants were divided into an experimental group (EG) and a control group (CG), where the EG performed a series of walking steps with a mobile app in their free time outside physical education classes. Adolescents in the CG continued to perform their physical activities as normal but did not use any mobile apps. Inclusion in the EG and CG was randomized, and the researchers were blinded. Results: An increase was found in the EG in corrected arm girth (mean difference –0.46; P=.05), curl-up repetitions (mean difference –6.35; P=.02) and push-up repetitions (mean difference –2.27; P=.04) after the intervention. In the CG, there was a significant increase in hip girth (mean difference –1.37; P=.05), corrected thigh girth (mean difference –1.28; P=.04), and muscle mass (mean difference –0.87; P=.04), as well as a significant decrease in competence (mean difference 3.08; P=.03). The covariates gender and age showed an effect on corrected arm girth (gender: P=.04), curl-up repetitions (gender: P=.04) and push-up repetitions (gender: P=.04) in the EG; while in the CG it affected corrected thigh girth (gender: P=.04), adherence to the Mediterranean diet (gender: P=.04 and age: P=.047) competence (gender: P=.04 and age: P=.04) and relatedness (gender: P=.05 and age: P=.04). No significant differences were found when comparing changes in the CG and EG. Conclusions: A 10-week program of mobile app use by adolescents who are overweight and obese for physical activity outside of school hours does not appear effective in producing improvements in body composition, physical fitness, or adequate psychological state as it does not appear to significantly increase physical activity. Trial Registration: ClinicalTrials.gov NCT06089876; http://clinicaltrials.gov/ct2/show/NCT06089876 %M 39656510 %R 10.2196/55243 %U https://www.jmir.org/2024/1/e55243 %U https://doi.org/10.2196/55243 %U http://www.ncbi.nlm.nih.gov/pubmed/39656510 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e64547 %T A Web-Based Mind-Body Intervention to Improve Resilience Among Patients With Nontraumatic Painful Upper-Extremity Conditions and Comorbid Risky Substance Use: Protocol for a Mixed Methods Study %A Levey,Nadine %A Chen,Neal %A Ditre,Joseph %A Sylvia,Louisa %A Mudgal,Chaitanya %A Bhashyam,Abhiram %A Garg,Rohit %A Ring,David %A Vranceanu,Ana-Maria %A Bakhshaie,Jafar %+ Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, 1 Bowdoin Square, 1st Floor, Suite 100, Boston, MA, 02114, United States, 1 8325388333, jbakhshaie@mgh.harvard.edu %K chronic pain %K upper-extremity conditions %K psychiatry %K mindfulness %K mind-body %K substance use %K web-based intervention development %D 2024 %7 9.12.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Nontraumatic painful upper-extremity conditions (NPUCs) are largely age-related degenerations that affect the majority of adults. Most patients with NPUCs do not seek medical care and adjust on their own. Among those who do seek care, approximately 20% report risky substance use, defined as a consumption pattern that increases the risk of harm to physical or psychosocial health. In the context of NPUC, risky substance use is associated with more intense pain, emotional distress, disability, and opioid or other substance misuse (ie, cross-tolerance). Consequently, risky substance use is a significant modifiable risk factor for the progression and maintenance of chronic pain-related disability and comorbid psychopathology among patients with NPUCs. Objective: This study aims to develop, adapt, and test the feasibility of the Web-Based Toolkit for Resilient Life Beyond Pain and Substance Use (Web-TIRELESS), a novel, asynchronous, and web-based mind-body intervention aimed at modifying maladaptive pain-coping behaviors in patients with NPUC and comorbid risky substance use. This study illustrates the proposed study design, methodology, and intervention content. Methods: In aim 1, we will conduct live video qualitative interviews (n=20) with care-seeking adult patients with NPUC and comorbid risky substance use to inform the development and refinement of Web-TIRELESS and study procedures. In aim 2, we propose an open pilot study (n=12) of Web-TIRELESS with exit interviews and pre- and postintervention assessments to evaluate the feasibility, credibility, and acceptability of Web-TIRELESS and refine study procedures. Aim 3 consists of a pilot feasibility randomized controlled trial of Web-TIRELESS versus minimally enhanced usual care (n=50), both of which follow a web-based modality, to demonstrate the feasibility of recruitment procedures and data collection, as well as the feasibility, credibility, and acceptability of Web-TIRELESS and the control condition (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. Results: Patient interviews (aim 1) concluded in May 2024 and qualitative analysis is expected to be completed in September 2024. Completion of aim 2 (data collection and analysis) is expected by June 2025. The completion of aim 3 and other study-related operations is anticipated by June 2027. Conclusions: We will develop and test Web-TIRELESS, the first asynchronous mind-body intervention specifically adapted to enhance resilience in response to chronic pain among individuals with NPUCs and comorbid risky substance use. Results from this 3-aim study (feasibility, acceptability, and satisfaction of Web-TIRELESS) will be leveraged to inform a future efficacy randomized controlled trial of Web-TIRELESS versus the minimally enhanced usual care. Trial Registration: ClinicalTrials.gov NCT06366633; https://clinicaltrials.gov/study/NCT06366633 International Registered Report Identifier (IRRID): DERR1-10.2196/64547 %M 39652859 %R 10.2196/64547 %U https://www.researchprotocols.org/2024/1/e64547 %U https://doi.org/10.2196/64547 %U http://www.ncbi.nlm.nih.gov/pubmed/39652859 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e52032 %T Rapid, Tailored Dietary and Health Education Through A Social Media Chatbot Microintervention: Development and Usability Study With Practical Recommendations %A Ali,Shahmir H %A Rahman,Fardin %A Kuwar,Aakanksha %A Khanna,Twesha %A Nayak,Anika %A Sharma,Priyanshi %A Dasraj,Sarika %A Auer,Sian %A Rouf,Rejowana %A Patel,Tanvi %A Dhar,Biswadeep %+ Saw Swee Hock School of Public Health, National University of Singapore, Tahir Foundation Building, 12 Science Drive 2, #10-01, Singapore, 117549, Singapore, 65 87918862, sali@nus.edu.sg %K social media %K chatbot %K conversational agent %K intervention %K diet %K health education %K feasibility %K microintervention %K innovation %K dietary education %K social media chatbot %K public health professional %K young adult %K Asian %K curriculum %D 2024 %7 9.12.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: There is an urgent need to innovate methods of health education, which can often be resource- and time-intensive. Microinterventions have shown promise as a platform for rapid, tailored resource dissemination yet have been underexplored as a method of standardized health or dietary education; social media chatbots display unique potential as a modality for accessible, efficient, and affordable educational microinterventions. Objective: This study aims to provide public health professionals with practical recommendations on the use of social media chatbots for health education by (1) documenting the development of a novel social media chatbot intervention aimed at improving dietary attitudes and self-efficacy among South Asian American young adults and (2) describing the applied experiences of implementing the chatbot, along with user experience and engagement data. Methods: In 2023, the “Roti” chatbot was developed on Facebook and Instagram to administer a 4-lesson tailored dietary health curriculum, informed by formative research and the Theory of Planned Behavior, to 18- to 29-year-old South Asian American participants (recruited through social media from across the United States). Each lesson (10-15 minutes) consisted of 40-50 prescripted interactive texts with the chatbot (including multiple-choice and open-response questions). A preintervention survey determined which lesson(s) were suggested to participants based on their unique needs, followed by a postintervention survey informed by the Theory of Planned Behavior to assess changes in attitudes, self-efficacy, and user experiences (User Experience Questionnaire). This study uses a cross-sectional design to examine postintervention user experiences, engagement, challenges encountered, and solutions developed during the chatbot implementation. Results: Data from 168 participants of the intervention (n=92, 54.8% Facebook; n=76, 45.2% Instagram) were analyzed (mean age 24.5, SD 3.1 years; n=129, 76.8% female). Participants completed an average of 2.6 lessons (13.9 minutes per lesson) and answered an average of 75% of questions asked by the chatbot. Most reported a positive chatbot experience (User Experience Questionnaire: 1.34; 81/116, 69.8% positive), with pragmatic quality (ease of use) being higher than hedonic quality (how interesting it felt; 88/116, 75.9% vs 64/116, 55.2% positive evaluation); younger participants reported greater hedonic quality (P=.04). On a scale out of 10 (highest agreement), participants reported that the chatbot was relevant (8.53), that they learned something new (8.24), and that the chatbot was helpful (8.28). Qualitative data revealed an appreciation for the cheerful, interactive messaging of the chatbot and outlined areas of improvement for the length, timing, and scope of text content. Quick replies, checkpoints, online forums, and self-administered troubleshooting were some solutions developed to meet the challenges experienced. Conclusions: The implementation of a standardized, tailored health education curriculum through an interactive social media chatbot displayed strong feasibility. Lessons learned from challenges encountered and user input provide a tangible roadmap for future exploration of such chatbots for accessible, engaging health interventions. %M 39652870 %R 10.2196/52032 %U https://formative.jmir.org/2024/1/e52032 %U https://doi.org/10.2196/52032 %U http://www.ncbi.nlm.nih.gov/pubmed/39652870 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e56959 %T Brief Video-Delivered Intervention to Reduce Anxiety and Improve Functioning in Older Veterans: Pilot Randomized Controlled Trial %A Gould,Christine E %A Carlson,Chalise %A Wetherell,Julie L %A Goldstein,Mary K %A Anker,Lauren %A Beaudreau,Sherry A %+ Geriatric Research, Education and Clinical Center, VA Palo Alto Health Care System, 3801 Miranda Ave, Palo Alto, CA, 94304, United States, 1 650 493 5000 ext 68899, Christine.Gould@va.gov %K guided self-management %K internet %K progressive relaxation %K technology %K anxiety %K telehealth %K veterans %K older adults %D 2024 %7 9.12.2024 %9 Original Paper %J JMIR Aging %G English %X Background: Older veterans with anxiety disorders encounter multiple barriers to receiving mental health services, including transportation difficulties, physical limitations, and limited access to providers trained to work with older persons. To address both accessibility and the shortage of available providers, evidence-based treatments that can be delivered via guided self-management modalities are a potential solution. Objective: This study aims to determine the feasibility and acceptability of a randomized controlled trial of 2 guided self-management interventions. This study compared the treatment effects of these 2 interventions (relaxation and health psychoeducation) on anxiety symptom severity and functioning in older veterans with anxiety disorders. Our exploratory aims examined factors related to home practices and treatment engagement and perceptions of the practices. Methods: Participants were randomized to one of two video-delivered interventions: (1) Breathing, Relaxation, and Education for Anxiety Treatment in the Home Environment (BREATHE)—breathing and progressive relaxation or (2) Healthy Living for Reduced Anxiety—psychoeducation about lifestyle changes. Telephone coaching calls were conducted weekly. Measures of anxiety, depression, and functioning were obtained at baseline, week 4 (end of treatment), week 8, and week 12. Participants completed a semistructured interview at week 12. Analyses included descriptive statistics to summarize measures of intervention engagement; mixed-effects models to characterize symptom change, and qualitative analyses. Results: Overall, 56 participants (n=48, 86% men; n=23, 41% from ethnic or racial minority groups; mean age 71.36, SD 6.19 y) were randomized. No difference in retention between study arms was found. The Healthy Living group (29/56, 52%) completed significantly more lessons (mean 3.68, SD 0.86) than the BREATHE group (27/56, 48%; mean 2.85, SD 1.43; t53=2.60; P=.01) but did not differ in completion of coaching calls. In the BREATHE group, greater baseline anxiety scores (r=–0.41; P=.03) and greater severity of medical comorbidity (r=–0.50; P=.009) were associated with fewer completed practices. There was no effect of intervention on change in total anxiety scores or functioning. For specific anxiety subtypes, Healthy Living produced a greater decline in somatic anxiety compared with BREATHE. Qualitative analyses found barriers to practicing, including difficulty setting time aside to practice, forgetting, or having other activities that interfered with BREATHE practices. Some participants described adapting their practice routine to fit their daily lives; some also used relaxation skills in everyday situations. Conclusions: These findings suggest that a larger randomized controlled trial of guided self-management approaches to treating late-life anxiety is feasible; however, BREATHE was not effective in reducing anxiety compared with Healthy Living. Possible contributing factors may have been the reliance on a single technique. Progressive relaxation was reported to be enjoyable for most participants, but maintaining home practices was challenging. Those with milder anxiety severity and fewer health problems were better able to adhere to practices. Trial Registration: ClinicalTrials.gov NCT02400723; https://clinicaltrials.gov/study/NCT02400723 %M 39652863 %R 10.2196/56959 %U https://aging.jmir.org/2024/1/e56959 %U https://doi.org/10.2196/56959 %U http://www.ncbi.nlm.nih.gov/pubmed/39652863 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e59588 %T An eHealth Intervention to Improve Quality of Life, Socioemotional, and Health-Related Measures Among Older Adults With Multiple Chronic Conditions: Randomized Controlled Trial %A Gustafson Sr,David H %A Mares,Marie-Louise %A Johnston,Darcie %A Vjorn,Olivia J %A Curtin,John J %A Landucci,Gina %A Pe-Romashko,Klaren %A Gustafson Jr,David H %A Shah,Dhavan V %+ Center for Health Enhancement Systems Studies, University of Wisconsin–Madison, 4111 Mechanical Engineering, 1513 University Ave, Madison, WI, 53706, United States, 1 608 890 1440, gina.landucci@wisc.edu %K eHealth %K telemedicine %K aged %K geriatrics %K multiple chronic conditions %K social support %K quality of life %K primary care %K mobile phone %K smartphone %D 2024 %7 6.12.2024 %9 Original Paper %J JMIR Aging %G English %X Background: In the United States, over 60% of adults aged 65 years or older have multiple chronic health conditions, with consequences that include reduced quality of life, increasingly complex but less person-centered treatment, and higher health care costs. A previous trial of ElderTree, an eHealth intervention for older adults, found socioemotional benefits for those with high rates of primary care use. Objective: This study tested the effectiveness of an ElderTree intervention designed specifically for older patients with multiple chronic conditions to determine whether combining it with primary care improved socioemotional and physical outcomes. Methods: In a nonblinded randomized controlled trial, 346 participants recruited from primary care clinics were assigned 1:1 to the ElderTree intervention or an attention control and were followed for 12 months. All participants were aged 65 years or older and had electronic health record diagnoses of at least three of 11 chronic conditions. Primary outcomes were mental and physical quality of life, psychological well-being (feelings of competence, connectedness, meaningfulness, and optimism), and loneliness. Tested mediators of the effects of the study arm (ElderTree vs active control) on changes in primary outcomes over time were 6-month changes in health coping, motivation, feelings of relatedness, depression, and anxiety. Tested moderators were sex, scheduled health care use, and number of chronic conditions. Data sources were surveys at baseline and 6 and 12 months comprising validated scales, and continuously collected ElderTree usage. Results: At 12 months, 76.1% (134/176) of ElderTree participants were still using the intervention. There was a significant effect of ElderTree (vs control) on improvements over 12 months in mental quality of life (arm × timepoint interaction: b=0.76, 95% CI 0.14-1.37; P=.02; 12-month ∆d=0.15) but no such effect on the other primary outcomes of physical quality of life, psychological well-being, or loneliness. Sex moderated the effects of the study arm over time on mental quality of life (b=1.33, 95% CI 0.09-2.58; P=.04) and psychological well-being (b=1.13, 95% CI 0.13-2.12; P=.03), with stronger effects for women than men. The effect of the study arm on mental quality of life was mediated by 6-month improvements in relatedness (α=1.25, P=.04; b=0.31, P<.001). Analyses of secondary and exploratory outcomes showed minimal effects of ElderTree. Conclusions: Consistent with the previous iteration of ElderTree, the current iteration designed for older patients with multiple chronic conditions showed signs of improving socioemotional outcomes but no impact on physical outcomes. This may reflect the choice of chronic conditions for inclusion, which need not have impinged on patients’ physical quality of life. Two ongoing trials are testing more specific versions of ElderTree targeting older patients coping with (1) chronic pain and (2) greater debilitation owing to at least 5 chronic conditions. Trial Registration: ClinicalTrials.gov NCT03387735; https://clinicaltrials.gov/study/NCT03387735 International Registered Report Identifier (IRRID): RR2-10.2196/25175 %M 39642938 %R 10.2196/59588 %U https://aging.jmir.org/2024/1/e59588 %U https://doi.org/10.2196/59588 %U http://www.ncbi.nlm.nih.gov/pubmed/39642938 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e53280 %T The Use of a Digital Well-Being App (Stay Strong App) With Indigenous People in Prison: Randomized Controlled Trial %A Perdacher,Elke %A Kavanagh,David %A Sheffield,Jeanie %A Dale,Penny %A Heffernan,Edward %+ Queensland Forensic Mental Health Service, Level 5, 270 Roma Street, Brisbane, Queensland, 4000, Australia, 61 7 3837 5820, elke.perdacher@health.qld.gov.au %K First Nations %K Indigenous %K digital mental health %K e-mental health %K mental health %K social and emotional well-being %K SEWB %K prisoner %K prison %D 2024 %7 6.12.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Indigenous Australians in custody experience much greater rates of poor mental health and well-being than those of the general community, and these problems are not adequately addressed. Digital mental health strategies offer innovative opportunities to address the problems, but little is known about their feasibility in or impact on this population. Objective: This study aims to conduct a pilot trial evaluating the impact of adding the Stay Strong app to mental health and well-being services for Indigenous women and men in custody. The trial compared immediate and 3-month delayed use of the app by the health service, assessing its effects on well-being, empowerment, and psychological distress at 3 and 6 months after the baseline. Methods: Indigenous participants were recruited from 3 high-security Australian prisons from January 2017 to September 2019. The outcome measures assessed well-being (Warwick-Edinburgh Mental Wellbeing Scale), empowerment (Growth and Empowerment Measure [GEM]—giving total, 14-item Emotional Empowerment Scale, and 12 Scenarios scores), and psychological distress (Kessler Psychological Distress Scale). Intention-to-treat effects on these outcomes were analyzed using linear mixed models. Results: Substantial challenges in obtaining ethical and institutional approval for the trial were encountered, as were difficulties in timely recruitment and retention due to staff shortages and the release of participants from prison before follow-up assessments and an inability to follow up with participants after release. A total of 132 prisoners (age: mean 33, SD 8 y) were randomized into either an immediate (n=82) or a delayed treatment (n=52) group. However, only 56 (42.4%) could be assessed at 3 months and 37 (28%) at 6 months, raising questions concerning the representativeness of the results. Linear improvements over time were seen in all outcomes (GEM total: Cohen d=0.99; GEM 14-item Emotional Empowerment Scale: Cohen d=0.94; GEM 12 Scenarios: Cohen d=0.87; Warwick-Edinburgh Mental Wellbeing Scale: Cohen d=0.76; Kessler Psychological Distress Scale: Cohen d=0.49), but no differential effects for group or the addition of the Stay Strong app were found. Conclusions: We believe this to be Australia’s first evaluation of a digital mental health app in prison and the first among Indigenous people in custody. While the study demonstrated that the use of a well-being app within a prison was feasible, staff shortages led to delayed recruitment and a consequent low retention, and significant beneficial effects of the app’s use within a forensic mental health service were not seen. Additional staff resources and a longer intervention may be needed to allow a demonstration of satisfactory retention and impact in future research. Trial Registration: ANZCTR ACTRN12624001261505; https://www.anzctr.org.au/ACTRN12624001261505.aspx %M 39642362 %R 10.2196/53280 %U https://mental.jmir.org/2024/1/e53280 %U https://doi.org/10.2196/53280 %U http://www.ncbi.nlm.nih.gov/pubmed/39642362 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53829 %T An Automated Conversational Agent Self-Help Program: Randomized Controlled Trial %A Foran,Heather M %A Kubb,Christian %A Mueller,Janina %A Poff,Spencer %A Ung,Megan %A Li,Margaret %A Smith,Eric Michael %A Akinyemi,Akinniyi %A Kambadur,Melanie %A Waller,Franziska %A Graf,Mario %A Boureau,Y-Lan %+ Department of Health Psychology, University of Klagenfurt, Universitaetstrasse 65067, Klagenfurt, 9020, Austria, 43 46327001641, Heather.Foran@aau.at %K well-being %K chatbot %K randomized controlled trial %K prevention %K flourishing %D 2024 %7 6.12.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Health promotion and growth-based interventions can effectively improve individual well-being; however, significant gaps in access and utilization still exist. Objective: This study aims to develop and test the effectiveness and implementation of a new, widely targeted conversational agent prevention program (Zenny) designed to enhance well-being. Methods: A total of 1345 individuals in the United States were recruited online and randomly assigned to either (1) a self-help program intervention delivered via an automated conversational agent on WhatsApp or (2) an active control group that had access to evidence-based wellness resources available online. The primary outcomes were well-being (measured using the 5-item World Health Organization Well-being Scale), psychosocial flourishing (assessed with the Flourishing Scale), and positive psychological health (evaluated with the Mental Health Continuum-Short Form). Outcome measures were collected at baseline and again 1 month postassessment. All analyses were conducted using an intention-to-treat approach. Results: Both groups showed significant improvements in well-being (self-help program intervention group effect size: Cohen d=0.26, P<.001; active control group effect size: d=0.24, P<.001), psychosocial flourishing (intervention: d=0.19, P<.001; active control: d=0.18, P<.001), and positive psychological health (intervention: d=0.17, P=.001; active control: d=0.24, P<.001) at postassessment. However, there were no significant differences in effectiveness between the 2 groups (P ranged from .56 to .92). As hypothesized a priori, a greater number of days spent actively engaging with the conversational agent was associated with larger improvements in well-being at postassessment among participants in the intervention group (β=.109, P=.04). Conclusions: The findings from this study suggest that the free conversational agent wellness self-help program was as effective as evidence-based web resources. Further research should explore strategies to increase participant engagement over time, as only a portion of participants were actively involved, and higher engagement was linked to greater improvements in well-being. Long-term follow-up studies are also necessary to assess whether these effects remain stable over time. Trial Registration: ClinicalTrials.gov NCT06208566; https://clinicaltrials.gov/ct2/show/NCT06208566; OSF Registries osf.io/ahe2r; https://doi.org/10.17605/osf.io/ahe2r %M 39641985 %R 10.2196/53829 %U https://www.jmir.org/2024/1/e53829 %U https://doi.org/10.2196/53829 %U http://www.ncbi.nlm.nih.gov/pubmed/39641985 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e56796 %T Exploring How Older Adults Experience semAPP, a 360° Media–Based Tool for Memory Assessment: Qualitative Study %A Bruni,Francesca %A Mancuso,Valentina %A Panigada,Jonathan %A Stramba-Badiale,Marco %A Cipresso,Pietro %A Pedroli,Elisa %+ Department of Theoretical and Applied Sciences, eCampus University, Via Isimbardi 10, Novedrate, 22060, Italy, 39 3460066231, v.mancuso95@gmail.com %K assessment %K virtual reality %K 360-degree videos %K user experience %K memory %K aging %K psycho gerontology %D 2024 %7 5.12.2024 %9 Original Paper %J JMIR Aging %G English %X Background: Technology is already a part of our daily lives, and its influence is growing rapidly. This evolution has not spared the health care field. Nowadays, a crucial challenge is considering aspects such as design, development, and implementation, highlighting their functionality, ease of use, compatibility, performance, and safety when a new technological tool is developed. As noted in many works, the abandonment rate is usually higher when a user has a terrible experience with these instruments. It would be appropriate to incorporate the final users—whether they are patients, health care professionals, or both—in the stages of instrument design to understand their needs and preferences. Since most apps that fail did not include end users and health care professionals in the development phase, their involvement at all stages of app development may increase their commitment and improve integration, self-management, and health outcomes. Objective: This study aims (1) to develop semAPP (spatial and episodic memory assessment application), a 360° media–based tool, to assess memory in aging by simulating a real-life situation and (2) to test the usability of the app and the connected experience in an end-user population. Methods: A total of 34 older adults participated in the study: 16 (47%) healthy individuals and 18 (53%) patients with mild cognitive impairment. They used semAPP and completed qualitative and quantitative measures. The app includes 2 parts: object recognition and spatial memory tasks. During the first task, users have to navigate in an apartment freely and visit rooms, and then they must recognize the right map of the house. In the second task, users are immersed in a living room, and they have to encode and then recall some target objects, simulating a relocation. We deployed this app on an 11.2-inch iPad, and we tested its usability and the experience of users interacting with the app. We conducted descriptive analyses for both the entire sample and each subgroup; we also conducted parametric and correlation analyses to compare groups and to examine the relationship between task execution and the virtual experience, as well as the acceptance of technology. Results: Both groups judged the app as an easy-to-use tool, and they were willing to use it. Moreover, the results match the idea that usability might be influenced by different factors depending on instrument and personal features, such as presentation, functionality, system performance, interactive behavior, attitudes, skills, and personality. Conclusions: The findings support the possibility of using semAPP in older patients, as well as the importance of designing and evaluating new technological tools, considering not only the general population but also the specific target ones. %M 39637375 %R 10.2196/56796 %U https://aging.jmir.org/2024/1/e56796 %U https://doi.org/10.2196/56796 %U http://www.ncbi.nlm.nih.gov/pubmed/39637375 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e60193 %T Impact of Providing a Personalized Data Dashboard on Ecological Momentary Assessment Compliance Among College Students Who Use Substances: Pilot Microrandomized Trial %A Linden-Carmichael,Ashley %A Stull,Samuel W %A Wang,Danny %A Bhandari,Sandesh %A Lanza,Stephanie T %+ The Edna Bennett Pierce Prevention Research Center, The Pennsylvania State University, 320E Biobehavioral Health Building, University Park, PA, 16802, United States, 1 541 346 1978, AshleyLC@uoregon.edu %K ecological momentary assessment %K data dashboard %K study compliance %K substance use %K substance use behavior %K college student %K alcohol %K cannabis %K cannabis use %K personalized data dashboard %K EMA protocol %K EMA %K health behaviors %K survey %K compliance %K self-reported %D 2024 %7 5.12.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: The landscape of substance use behavior among young adults has observed rapid changes over time. Intensive longitudinal designs are ideal for examining and intervening in substance use behavior in real time but rely on high participant compliance in the study protocol, representing a significant challenge for researchers. Objective: This study aimed to evaluate the effect of including a personalized data dashboard (DD) in a text-based survey prompt on study compliance outcomes among college students participating in a 21-day ecological momentary assessment (EMA) study. Methods: Participants (N=91; 61/91, 67% female and 84/91, 92% White) were college students who engaged in recent alcohol and cannabis use. Participants were randomized to either complete a 21-day EMA protocol with 4 prompts/d (EMA Group) or complete the same EMA protocol with 1 personalized message and a DD indicating multiple metrics of progress in the study, delivered at 1 randomly selected prompt/d (EMA+DD Group) via a microrandomized design. Study compliance, completion time, self-reported protocol experiences, and qualitative responses were assessed for both groups. Results: Levels of compliance were similar across groups. Participants in the EMA+DD Group had overall faster completion times, with significant week-level differences in weeks 2 and 3 of the study (P=.047 and P=.03, respectively). Although nonsignificant, small-to-medium effect sizes were observed when comparing the groups in terms of compensation level (P=.08; Cohen w=0.19) and perceived burden (P=.09; Cohen d=-0.36). Qualitative findings revealed that EMA+DD participants perceived that seeing their progress facilitated engagement. Within the EMA+DD Group, providing a DD at the moment level did not significantly impact participants’ likelihood of completing the EMA or completion time at that particular prompt (all P>.05), with the exception of the first prompt of the day (P=.01 and P<.001). Conclusions: Providing a DD may be useful to increase engagement, particularly for researchers aiming to assess health behaviors shortly after a survey prompt is deployed to participants’ mobile devices. International Registered Report Identifier (IRRID): RR2-10.2196/57664 %M 39637378 %R 10.2196/60193 %U https://formative.jmir.org/2024/1/e60193 %U https://doi.org/10.2196/60193 %U http://www.ncbi.nlm.nih.gov/pubmed/39637378 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e59610 %T Influencing Factors and Implementation Pathways of Adherence Behavior in Intelligent Personalized Exercise Prescription: Qualitative Study %A Xu,Xuejie %A Zhang,Guoli %A Xia,Yuxin %A Xie,Hui %A Ding,Zenghui %A Wang,Hongyu %A Ma,Zuchang %A Sun,Ting %+ School of Nursing, Bengbu Medical University, Number 2600, Donghai Avenue, Bengbu, 233030, China, 86 18005529759, cangwuge21@163.com %K exercise prescription %K adherence behavior %K qualitative %K influence factors %K Transtheoretical Model %K multiple motivations of behavior %D 2024 %7 5.12.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Personalized intelligent exercise prescriptions have demonstrated significant benefits in increasing physical activity and improving individual health. However, the health benefits of these prescriptions depend on long-term adherence. Therefore, it is essential to analyze the factors influencing adherence to personalized intelligent exercise prescriptions and explore the intrinsic relationship between individual behavioral motivation and adherence. This understanding can help improve adherence and maximize the effectiveness of such prescriptions. Objective: This study aims to identify the factors influencing adherence behavior among middle-aged and older community residents who have been prescribed personalized exercise regimens through an electronic health promotion system. It also explores how these factors affect the initiation and maintenance of adherence behavior. Methods: We used purposive sampling to conduct individual, face-to-face semistructured interviews based on the Transtheoretical Model (TTM) with 12 middle-aged and older community residents who had been following personalized exercise regimens for 8 months. These residents had received detailed exercise health education and guidance from staff. The interviews were recorded, transcribed verbatim, and analyzed using NVivo software through grounded theory. We then applied the TTM and multibehavioral motivation theory to analyze the factors influencing adherence. Additionally, the relationship between behavioral motivations and adherence was explored. Results: Using the behavior change stages of the TTM, open coding yielded 21 initial categories, which were then organized into 8 main categories through axial coding: intrinsic motivation, extrinsic motivation, benefit motivation, pleasure motivation, achievement motivation, perceived barriers, self-regulation, and optimization strategies. Selective coding further condensed these 8 main categories into 3 core categories: “multitheory motivation,” “obstacle factors,” and “solution strategies.” Using the coding results, a 3-level model of factors influencing adherence to intelligent personalized exercise prescriptions was developed. Based on this, an implementation path for promoting adherence to intelligent personalized exercise prescriptions was proposed by integrating the model with the TTM. Conclusions: Adherence to personalized exercise prescriptions is influenced by both facilitating factors (eg, multibehavioral motivation, optimization strategies) and obstructive factors (eg, perceived barriers). Achieving and maintaining adherence is a gradual process, shaped by a range of motivations and factors. Personalized solutions, long-term support, feedback mechanisms, and social support networks are essential for promoting adherence. Future efforts should focus on enhancing adherence by strengthening multibehavioral motivation, optimizing solutions, and addressing barriers to improve overall adherence. %M 39636668 %R 10.2196/59610 %U https://mhealth.jmir.org/2024/1/e59610 %U https://doi.org/10.2196/59610 %U http://www.ncbi.nlm.nih.gov/pubmed/39636668 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 10 %N %P e58014 %T Delivering a Group-Based Quality of Life Intervention to Young Adult Cancer Survivors via a Web Platform: Feasibility Trial %A Fox,Rina S %A Torres,Tara K %A Badger,Terry A %A Katsanis,Emmanuel %A Yang,DerShung %A Sanford,Stacy D %A Victorson,David E %A Yanez,Betina %A Penedo,Frank J %A Antoni,Michael H %A Oswald,Laura B %K cancer survivors %K survivorship %K clinical trials %K psychosocial intervention %K usability testing %K digital therapeutics %K young adults %K nonrandomized %D 2024 %7 4.12.2024 %9 %J JMIR Cancer %G English %X Background: Young adult (YA) cancer survivors frequently report unmet health information and peer support needs, as well as poor health-related quality of life (HRQOL). YAs also have expressed a desire that behavioral interventions be convenient. In response to this, our team has developed a 10-week, group-based, supportive care intervention titled TOGETHER to improve YA cancer survivors’ HRQOL. TOGETHER is delivered via videoconference and has shown initial feasibility, acceptability, and promise for improving HRQOL among YA survivors. Objective: In an effort to increase convenience, the goal of this 2-part study was to design and test a website to host the TOGETHER intervention for YA cancer survivors aged 18‐39 years at the time of participation and aged 15‐39 years at the time of initial cancer diagnosis. Methods: In part 1, we leveraged an existing web-based platform and adapted it to meet the needs of TOGETHER. We conducted 3 iterative waves of usability testing with 3 YAs per wave to refine the website. In part 2, we conducted a single-group feasibility trial of TOGETHER using the website. Primary outcomes were feasibility (ie, recruitment, retention, and attendance) and acceptability (ie, satisfaction). Results: Usability testing participants (n=9) indicated that the TOGETHER website was easy to use (mean 5.9, SD 1.3) and easy to learn (mean 6.5, SD 0.9; possible ranges 1‐7). Qualitative feedback identified needed revisions to the aesthetics (eg, images), content (eg, session titles), function (eg, clarity of functionality), and structure (eg, expandable sections), which were implemented. In the feasibility trial, participants (n=7) were an average of 25 (SD 4.7) years old and mostly non-Hispanic White (n=4, 57%). Recruitment (58%) and retention (71%) rates and average session attendance (mean 7.1 , SD 4.2) supported feasibility. Participant agreement with positive statements about TOGETHER and average satisfaction ratings (mean 5.06, SD 1.64; possible range: 1‐7) demonstrated acceptability. Conclusions: Results supported the usability, feasibility, and acceptability of the TOGETHER program and website. By providing the content digitally, the program effectively addresses YAs’ expressed preference for convenience. Future studies are needed to increase TOGETHER’s efficiency and explore its efficacy for improving targeted outcomes. Trial Registration: NCT05597228, October 24, 2022; https://clinicaltrials.gov/study/NCT05597228 %R 10.2196/58014 %U https://cancer.jmir.org/2024/1/e58014 %U https://doi.org/10.2196/58014 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e50664 %T Effectiveness of an Internet-Based Self-Help Acceptance and Commitment Therapy Program on Medical Students’ Mental Well-Being: Follow-Up Randomized Controlled Trial %A Wang,Difan %A Lin,Bingyan %A Zhang,Shuangxi %A Xu,Wei %A Liu,Xinying %+ Faculty of Psychology, Beijing Normal University, 19 Xinjiekouwai Street Haidian District, Beijing, 100875, China, 86 010 66939114, livingxw@163.com %K internet-delivered self-help acceptance and commitment therapy %K depression %K anxiety %K stress %K psychological inflexibility %K obsessive-compulsive symptoms %K medical students %K iACT 2.0 program %D 2024 %7 4.12.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Psychological distress is a growing problem among medical students worldwide. This highlights the need for psychological interventions to focus on mental health and improve well-being in this population. Objective: This study developed an internet-based, self-help, acceptance and commitment therapy program (iACT 2.0), aiming to examine its effectiveness in reducing depression, anxiety, stress, psychological inflexibility (PI), and obsessive-compulsive symptoms (OCSs) among medical students. Methods: A total of 520 Chinese postgraduate medical students were randomly assigned to either an iACT 2.0 intervention group (n=260; six online lessons, once every 5 days) or a control condition (n=260; without intervention). Participants completed questionnaires including the 21-item Depression Anxiety Stress Scale, the revised Obsessive-Compulsive Inventory, and the Multidimensional Psychological Flexibility Inventory at the preintervention (T1), postintervention (T2), and 1-month follow-up time points (T3). No therapist support was provided during the 1-month iACT 2.0 intervention period. Data were collected via an online platform and analyzed using repeated-measures ANOVA. Results: Participants in the intervention group demonstrated a significant decrease in depression, anxiety, stress, PI, and OCSs compared to the control group after the intervention (F=22.9-672.04, all P<.001). Specifically, the intervention group showed significant reductions in all measured outcomes from the preintervention to postintervention time point and at the 1-month follow-up (all P<.001). In contrast, no significant changes were observed in the control group over the same period (all P>.05). The groups did not differ significantly at baseline (all P>.05). Significant differences were noted at both the postintervention and follow-up time points (all P<.001). Conclusions: This study demonstrated that the newly developed iACT 2.0 was effective in reducing depression, anxiety, stress, PI, and OCSs. Notably, the positive effects of the intervention persisted at the 1-month follow-up. This program can offer a useful addition to existing mental illness treatment and lead to improvements in clinical and psychotherapy planning while simultaneously reducing the burden on traditional counseling and services. Trial Registration: Chinese Clinical Trial Registry ChiCTR2300070725; https://tinyurl.com/2h75wx8n %M 39631061 %R 10.2196/50664 %U https://www.jmir.org/2024/1/e50664 %U https://doi.org/10.2196/50664 %U http://www.ncbi.nlm.nih.gov/pubmed/39631061 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53685 %T Technology-Based Interventions for Substance Use Treatment Among People Who Identify as African American or Black, Hispanic or Latino, and American Indian or Alaska Native: Scoping Review %A Moore,Sarah K %A Boggis,Jesse S %A Gauthier,Phoebe R %A Lambert-Harris,Chantal A %A Hichborn,Emily G %A Bell,Kathleen D %A Saunders,Elizabeth C %A Montgomery,LaTrice %A Murphy,Eilis I %A Turner,Avery M %A Agosti,Nico %A McLeman,Bethany M %A Marsch,Lisa A %+ Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, 46 Centerra Parkway, EverGreen Center, Suite 315, Lebanon, NH, 03766, United States, 1 19176789280, sarah.k.moore@dartmouth.edu %K technology-based interventions %K substance use %K treatment %K health equity %K underrepresented %K scoping review %K mobile phone %D 2024 %7 3.12.2024 %9 Review %J J Med Internet Res %G English %X Background: In the United States, racial and ethnic disparities in substance use treatment outcomes are persistent, especially among underrepresented minority (URM) populations. Technology-based interventions (TBIs) for substance use treatment show promise in reducing barriers to evidence-based treatment, yet no studies have described how TBIs may impact racial or ethnic health equity. Objective: This study explored whether TBIs in substance use treatment research promote health equity among people who identify as African American or Black, Hispanic or Latino, and American Indian or Alaska Native through their inclusion in research. We explored whether research that includes the aforementioned groups consciously considers race and/or ethnicity beyond including these populations as participants. Methods: We conducted a scoping review of 5 electronic databases to identify TBIs in substance use treatment studies published in English between January 2000 and March 2021. Studies were included if ≥50% of participants identified as African American or Black, Hispanic or Latino, or American Indian or Alaska Native when combined. Included studies were evaluated for conscious consideration of race and ethnicity in at least one manuscript section. Finally, we conducted a critical appraisal of each study’s potential to facilitate insights into the impact of a TBI for members of specific URM groups. Results: Of 6897 titles and abstracts screened and 1158 full-text articles assessed for eligibility, nearly half (532/1158, 45.9%) of the full-text articles were excluded due to the absence of data on race, ethnicity, or not meeting the aforementioned demographic eligibility criteria. Overall, 110 studies met the inclusion criteria. Study designs included 39.1% (43/110) randomized trials, and 35.5% (39/110) feasibility studies. In total, 47.3% (52/110) of studies used computer-based interventions, including electronic screening, brief interventions, and referrals to treatment, whereas 33.6% (37/110) used interactive voice response, ecological momentary assessment or interventions, or SMS text messaging via mobile phones. Studies focused on the following substances: alcohol or drugs (45/110, 40.9%), alcohol alone (26/110, 23.6%), opioids (8/110, 7.3%), cannabis (6/110, 5.5%), cocaine (4/110, 3.6%), and methamphetamines (3/110, 2.7%). Of the studies that consciously considered race or ethnicity (29/110, 26.4%), 6.4% (7/110) explicitly considered race or ethnicity in all manuscript sections. Overall, 28.2% (31/110) of the studies were critically appraised as having a high confidence in the interpretability of the findings for specific URM groups. Conclusions: While the prevalence of TBIs in substance use treatment has increased recently, studies that include and consciously consider URM groups are rare, especially for American Indian or Alaska Native and Hispanic or Latino groups. This review highlights the limited research on TBIs in substance use treatment that promotes racial and ethnic health equity and provides context, insights, and direction for researchers working to develop and evaluate digital technology substance use interventions while promoting health equity. %M 39626234 %R 10.2196/53685 %U https://www.jmir.org/2024/1/e53685 %U https://doi.org/10.2196/53685 %U http://www.ncbi.nlm.nih.gov/pubmed/39626234 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e57708 %T Effectiveness and Acceptability of Asynchronous Digital Health in Asthma Care: Mixed Methods Systematic Review %A Uzzaman,Nazim %A Hammersley,Victoria %A McClatchey,Kirstie %A Sheringham,Jessica %A Singh,Diksha %A Habib,GM Monsur %A Pinnock,Hilary %+ Usher Institute, The University of Edinburgh, 5-7 Little France Road, The Usher Building, Edinburgh, EH16 4UX, United Kingdom, 44 01316517869, hilary.pinnock@ed.ac.uk %K digital health %K asthma %K asynchronous %K asthma care %K effectiveness %K acceptability %K mixed-methods review %K systematic review %K barrier %K remote synchronous %K chronic respiratory disease %K self-management %K digital technology %K asynchronous consultation %K caregiver %K PRISMA %D 2024 %7 3.12.2024 %9 Review %J J Med Internet Res %G English %X Background: Asynchronous digital health (eg, web-based portal, text, and email communication) can overcome practical barriers associated with in-person and remote synchronous (real-time) consultations. However, little is known about the effectiveness and acceptability of asynchronous digital health to support care for individuals with asthma (eg, asthma reviews). Objective: We aimed to systematically review the qualitative and quantitative evidence on the role of asynchronous digital health for asthma care. Methods: Following Cochrane methodology, we searched 6 databases (January 2001-July 2022; search update: September 2023) for quantitative, qualitative, or mixed methods studies supporting asthma care using asynchronous digital health. Screening and data extraction were duplicated. We assessed the risk of bias in the clinical outcomes of randomized controlled trials included in the meta-analysis using the revised Cochrane risk of bias tool. For the remaining studies, we evaluated the methodological quality using the Downs and Black checklist, critical appraisal skills program, and mixed methods appraisal tool for quantitative, qualitative, and mixed methods studies, respectively. We determined the confidence in the evidence using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) criteria. We conducted a meta-analysis of trial data and a thematic analysis of qualitative data. Results: We included 30 studies (20 quantitative, 6 qualitative, and 4 mixed methods) conducted in 9 countries involving individuals with asthma, their caregivers, and health care professionals. Asynchronous digital consultations linked with other functionalities, compared to usual care, improved asthma control (standardized mean difference 0.32, 95% CI 0.02-0.63; P=.04) and reduced hospitalizations (risk ratio 0.36; 95% CI 0.14-0.94; P=.04). However, there were no significant differences in quality of life (standardized mean difference 0.16; 95% CI –0.12 to 0.43; P=.26) or emergency department visits (risk ratio 0.83; 95% CI 0.33-2.09; P=.69). Patients appreciated the convenience of asynchronous digital health, though health care professionals expressed concerns. Successful implementation necessitated an organizational approach. Integrative synthesis underscored the ease of asking questions, monitoring logs, and medication reminders as key digital functionalities. Conclusions: Despite low confidence in evidence, asynchronous consultation supported by digital functionalities is an effective and convenient option for nonemergency asthma care. This type of consultation, well accepted by individuals with asthma and their caregivers, offers opportunities for those facing challenges with traditional synchronous consultations due to lifestyle or geographic constraints. However, efficient organizational strategies are needed to manage the associated workload. Trial Registration: PROSPERO CRD42022344224; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=344224 International Registered Report Identifier (IRRID): RR2-10.1371/journal.pone.0281538 %M 39626243 %R 10.2196/57708 %U https://www.jmir.org/2024/1/e57708 %U https://doi.org/10.2196/57708 %U http://www.ncbi.nlm.nih.gov/pubmed/39626243 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e60353 %T Investigating the Best Practices for Engagement in Remote Participatory Design: Mixed Methods Analysis of 4 Remote Studies With Family Caregivers %A Jolliff,Anna %A Holden,Richard J %A Valdez,Rupa %A Coller,Ryan J %A Patel,Himalaya %A Zuraw,Matthew %A Linden,Anna %A Ganci,Aaron %A Elliott,Christian %A Werner,Nicole E %+ Department of Health & Wellness Design, School of Public Health - Bloomington, Indiana University Bloomington, 1025 E. 7th Street, Bloomington, IN, 47405, United States, 1 812 855 1561, annjoll@iu.edu %K user-centered design %K family caregivers %K mobile health %K digital health %K web-based intervention %K stakeholder engagement %K patient engagement %K community-based participatory action research %K community participation %K qualitative evaluation %D 2024 %7 3.12.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital health interventions are a promising method for delivering timely support to underresourced family caregivers. The uptake of digital health interventions among caregivers may be improved by engaging caregivers in participatory design (PD). In recent years, there has been a shift toward conducting PD remotely, which may enable participation by previously hard-to-reach groups. However, little is known regarding how best to facilitate engagement in remote PD among family caregivers. Objective: This study aims to (1) understand the context, quality, and outcomes of family caregivers’ engagement experiences in remote PD and (2) learn which aspects of the observed PD approach facilitated engagement or need to be improved. Methods: We analyzed qualitative and quantitative data from evaluation and reflection surveys and interviews completed by research and community partners (family caregivers) across 4 remote PD studies. Studies focused on building digital health interventions for family caregivers. For each study, community partners met with research partners for 4 to 5 design sessions across 6 months. After each session, partners completed an evaluation survey. In 1 of the 4 studies, research and community partners completed a reflection survey and interview. Descriptive statistics were used to summarize quantitative evaluation and reflection survey data, while reflexive thematic analysis was used to understand qualitative data. Results: In 62.9% (83/132) of evaluations across projects 1-3, participants described the session as “very effective.” In 74% (28/38) of evaluations for project 4, participants described feeling “extremely satisfied” with the session. Qualitative data relating to the engagement context identified that the identities of partners, the technological context of remote PD, and partners’ understanding of the project and their role all influenced engagement. Within the domain of engagement quality, relationship-building and co-learning; satisfaction with prework, design activities, time allotted, and the final prototype; and inclusivity and the distribution of influence contributed to partners’ experience of engagement. Outcomes of engagement included partners feeling an ongoing interest in the project after its conclusion, gratitude for participation, and a sense of meaning and self-esteem. Conclusions: These results indicate high satisfaction with remote PD processes and few losses specific to remote PD. The results also demonstrate specific ways in which processes can be changed to improve partner engagement and outcomes. Community partners should be involved from study inception in defining the problem to be solved, the approach used, and their roles within the project. Throughout the design process, online tools may be used to check partners’ satisfaction with design processes and perceptions of inclusivity and power-sharing. Emphasis should be placed on increasing the psychosocial benefits of engagement (eg, sense of community and purpose) and increasing opportunities to participate in disseminating findings and in future studies. %R 10.2196/60353 %U https://www.jmir.org/2024/1/e60353 %U https://doi.org/10.2196/60353 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53834 %T Patients’ and Clinicians’ Experiences Using a Real-Time Remote Monitoring System for Chemotherapy Symptom Management (ASyMS): Qualitative Study %A McCann,Lisa %A Lewis,Liane %A Oduntan,Olubukola %A Harris,Jenny %A Darley,Andrew %A Berg,Geir V %A Lubowitzki,Simone %A Cheevers,Katy %A Miller,Morven %A Armes,Jo %A Ream,Emma %A Fox,Patricia %A Furlong,Eileen Patricia %A Gaiger,Alexander %A Kotronoulas,Grigorios %A Patiraki,Elisabeth %A Katsaragakis,Stylianos %A McCrone,Paul %A Miaskowski,Christine %A Cardone,Antonella %A Orr,Dawn %A Flowerday,Adrian %A Skene,Simon %A Moore,Margaret %A De Souza,Nicosha %A Donnan,Peter %A Maguire,Roma %+ Digital Health and Wellness Group (DHaWG), Department of Computer and Information Sciences, University of Strathclyde, Livingstone Tower, 26 Richmond Street, Glasgow, G1 1XQ, United Kingdom, 44 +441415483587, lisa.mccann@strath.ac.uk %K cancer %K clinician experiences %K digital interventions %K patient experiences %K remote monitoring %K qualitative methods %D 2024 %7 3.12.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Patients receiving chemotherapy require ongoing symptom monitoring and management to optimize their outcomes. In recent years, digital remote monitoring interventions have emerged to provide enhanced cancer care delivery experiences to patients and clinicians. However, patient and clinician experiential evaluations of these technologies are rare. Therefore, we explored user experiences and perceptions of one such intervention—Advanced Symptom Management System (ASyMS)—after its scaled deployment in the context of the Electronic Symptom Management System Remote Technology (eSMART) trial. The eSMART trial was a large, multicenter randomized controlled trial to evaluate the efficacy of ASyMS in 12 clinical sites in 5 European countries. Objective: In this qualitative study, both patients’ and clinicians’ experiences of using ASyMS for up to 6 cycles of chemotherapy were explored to understand the impact of ASyMS on patients’ experiences, clinical practice, and supportive care delivery. Methods: For this analysis, individual, semistructured, one-to-one interviews with 29 patients with breast, colorectal, and hematological cancers and 18 clinicians from Austria, Greece, Ireland, Norway, and the United Kingdom were conducted. Interviews focused on patients’ and clinicians’ experiences of using ASyMS, care organization and changes in practice following the introduction of ASyMS, perceived changes in care associated with the use of ASyMS, and its potential for future integration into routine chemotherapy care pathways. Results: Thematic analysis identified several themes that describe patients’ and clinicians’ experiences using ASyMS. One central orienting theme—ASyMS as a facilitator of change—was supported by 5 key themes associated with human and technology monitoring: reassurance, enhanced communications and relationships, knowing what is “normal” and what is to be expected, enhancing cancer care experiences, and informing future cancer care. Conclusions: This study is the first to evaluate both patients’ and clinicians’ experiences of using a digital health intervention to remotely monitor chemotherapy symptoms across 5 countries. Experiences with ASyMS were positive from both patients’ and clinicians’ perspectives, although some improvements to support the wider-scale rollout and sustained implementation were identified. Overall, this study demonstrates that real-time remote monitoring systems can help patients feel more reassured during their chemotherapy treatments and can help clinicians provide the right care, at the right time, and in the right place. Trial Registration: ClinicalTrials.gov NCT02356081; https://clinicaltrials.gov/study/NCT02356081 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2016-015016 %M 39626227 %R 10.2196/53834 %U https://www.jmir.org/2024/1/e53834 %U https://doi.org/10.2196/53834 %U http://www.ncbi.nlm.nih.gov/pubmed/39626227 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e58682 %T An Image-Recognition Dietary Assessment App for Adolescents With Obesity: Pilot Randomized Controlled Trial %A Oei,Krista %A Choi,Elizabeth EY %A Bar-Dayan,Alisa %A Stinson,Jennifer N %A Palmert,Mark R %A Alfonsi,Jeffrey E %A Hamilton,Jill %+ Division of Endocrinology, The Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G1X8, Canada, 1 4168131500, krista.oei@sickkids.ca %K obesity %K weight management %K dietary assessment %K nutrition %K adolescent %K digital health app %K mHealth %K mobile health %K image recognition %K teens %K weight %K youth %K diet %K dietary %K dietary app %K usability %K feasibility %K pilot randomized controlled trial %K obesity management %K nutritional %K user %K patient engagement %K mobile phone %D 2024 %7 2.12.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Adolescence is a period of increased susceptibility to developing obesity-related health issues due to poor eating patterns and increased sedentary behaviors. Recommendations for pediatric obesity management include dietary assessments. However, adolescents often avoid food logging through traditional methods. The use of image-recognition dietary assessment apps in adolescents with obesity is not well studied. Eating for Wellness (E4W) is a mobile app that determines the nutritional content of meals from photos and incorporates nutritional goal setting. Nutritional data can be displayed for health care providers (HCPs) via the Clinician Portal, while the data are presented to the user in a manner that minimizes the focus on calorie counting. Objective: This study aims to evaluate the usability and feasibility of E4W, a mobile health app designed to improve dietary intake in adolescents with obesity attending an obesity clinic, using a phased approach. Methods: The overall study was conducted in 2 phases to refine and evaluate E4W. In Phase 1, usability was tested through 3 iterative cycles of patient interviews. A total of 14 patient participants, aged 12-18 years with a BMI≥97th percentile, were included. Participants performed standardized scenario-based tasks in E4W and provided feedback on the app. Two iterative cycles were conducted for HCPs (n=4). Refinements were made during each cycle based on issues encountered and feedback provided. In Phase 2, a pilot randomized controlled trial of 32 adolescents (16 adolescents enrolled in the experimental group for 1 month, and 16 controls enrolled for 1 month) was completed. Both groups met with their dietitian at baseline, midstudy, and 1 month following their baseline visit to discuss goals and eating patterns. The control group was instructed to take photos of all intake using their default phone camera, without access to E4W, while those in the experimental group received full access to E4W. The primary outcome was the feasibility of implementation. Secondary outcomes examined overall change in dietary intake and achievement of nutritional goals. Results: Usability testing demonstrated that E4W and the Clinician Portal were easy to use, efficient, and well-liked by patients and HCPs. Feasibility testing revealed high patient acceptability scores. However, significant technical challenges were encountered. Although the use of E4W did not significantly impact patient engagement (control: mean 0.9, SD 0.7; experimental: mean 1.7, SD 1.9; P=.14), there were outliers in the experimental group with very high engagement and improved self-reported efficacy. Overall, there was no improvement in dietary intake, although assessment was hindered by poor adherence to traditional methods of food logging. Conclusions: E4W and the Clinician Portal were well-received by patients and HCPs. Further research is warranted and planned to determine if E4W can improve dietary intake and achievement of nutritional goals in adolescents with obesity. Trial Registration: ClinicalTrials.gov NCT05548868; https://clinicaltrials.gov/study/NCT05548868 %M 39621405 %R 10.2196/58682 %U https://formative.jmir.org/2024/1/e58682 %U https://doi.org/10.2196/58682 %U http://www.ncbi.nlm.nih.gov/pubmed/39621405 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e59136 %T The Effectiveness of Therapeutic Exercise Interventions With Virtual Reality on Balance and Walking Among Persons With Chronic Stroke: Systematic Review, Meta-Analysis, and Meta-Regression of Randomized Controlled Trials %A Krohn,Maria %A Rintala,Aki %A Immonen,Jaakko %A Sjögren,Tuulikki %+ Faculty of Sport and Health Sciences, University of Jyväskylä, PL 35, Keskussairaalantie 4, Jyväskylä, FI-40014, Finland, 358 405493755, maria_krohn@icloud.com %K stroke %K chronic %K virtual reality %K physiotherapy %K therapeutic exercise %K balance %K walking %D 2024 %7 2.12.2024 %9 Review %J J Med Internet Res %G English %X Background: Well-targeted balance, walking, and weight-shift training can improve balance capabilities in the chronic phase of stroke. There is an urgent need for a long-term approach to rehabilitation that extends beyond the acute and subacute phases, supporting participation without increasing the demand for health care staff. Objective: This study aims to evaluate the effectiveness of therapeutic exercise interventions with virtual reality (VR) training on balance and walking at the activity and participation levels in individuals with chronic stroke, compared with control groups receiving no treatment, conventional physical therapy, specific training, similar treatment, or identical treatment without VR. Methods: Studies were searched across 6 databases. The inclusion criteria were as follows: Adults aged 18 years or older with a stroke diagnosis for at least 6 months (population). Therapeutic exercises within a VR environment, using VR glasses or interactive games (intervention). Control groups without the use of VR (including no treatment, conventional physical therapy, specific training, similar treatment without VR, or identical treatment without the additional use of VR; comparison). We evaluated the Berg Balance Scale score, Functional Reach Test performance, Activities-specific Balance Confidence Scale score, Six-minute Walk Test, Two-minute Walk Test, 10-meter Walk Test results, and cadence (outcome measures). We investigated randomized controlled trials (study design). A meta-analysis and a meta-regression analysis were conducted to evaluate whether the content of VR interventions or control groups, as well as the level of VR immersion used, was related to balance or walking outcomes. Results: A total of 43 randomized controlled trials involving 1136 participants were included in this review. The use of VR training in therapeutic exercise interventions had a large effect on balance (standardized mean difference 0.51, 95% CI 0.29-0.72; P<.001) and a moderate effect on walking (standardized mean difference 0.31, 95% CI 0.09-0.53; P=.006) in individuals with chronic stroke, compared with pooled control groups (no treatment, conventional physical therapy, specific training, similar treatment, or identical treatment without the use of VR). According to the meta-regression findings, the content of VR interventions (P=.52), the type of control groups (P=.79), and the level of VR immersion (P=.82) were not significantly related to the pooled balance or walking outcomes. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) was moderate for balance and low for walking. Conclusions: Therapeutic exercise training with VR had a positive, albeit moderate, effect on balance and a low impact on walking at the level of activity (capacity), even in the chronic phase of stroke, without serious side effects. The results are applicable to working-aged stroke rehabilitees who are able to walk without assistance. Further research is needed with defined VR methods and outcomes that assess performance at the level of real-life participation. %M 39621381 %R 10.2196/59136 %U https://www.jmir.org/2024/1/e59136 %U https://doi.org/10.2196/59136 %U http://www.ncbi.nlm.nih.gov/pubmed/39621381 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e54941 %T Digital Interventions for Symptoms of Borderline Personality Disorder: Systematic Review and Meta-Analysis %A Lindsay,Julia A B %A McGowan,Niall M %A Henning,Thomas %A Harriss,Eli %A Saunders,Kate E A %+ Department of Psychiatry, University of Oxford, Warneford Hospital, Warneford Ln, Oxford, OX3 7JX, United Kingdom, 44 01865613196, julia.lindsay@psych.ox.ac.uk %K borderline personality disorder %K BPD %K digital intervention %K digital health %K digital therapeutics %K persuasive system design %K systematic review %K meta-analysis %K suicidal ideation %K paranoia %K single symptom %K mental health %K behavior change %K treatment %K effectiveness %K symptom %K suicide %K mobile phone %D 2024 %7 29.11.2024 %9 Review %J J Med Internet Res %G English %X Background: Borderline personality disorder (BPD) is a mental health condition with insufficient care availability worldwide. Digital mental health interventions could reduce this treatment gap. Persuasive system design (PSD) is a conceptual framework outlining elements of digital interventions that support behavior change. Objective: This systematic review aims to characterize digital interventions targeting BPD symptoms, assess treatment efficacy, and identify its association with intervention features, including PSD elements. Methods: A systematic review of automated digital interventions targeting symptoms of BPD was conducted. Eligible studies recruited participants aged ≥18 years, based on a diagnosis of BPD or one of its common comorbidities, or as healthy volunteers. OVID Embase, OVID MEDLINE, OVID PsycINFO, and the Cochrane Central Register for Controlled Trials were searched on July 19, 2022, and February 28, 2023. Intervention characteristics were tabulated. A meta-analysis of randomized controlled trials (RCTs) determined treatment effects separately for each core symptom of BPD using Hedges g. Associations between the treatment effect and intervention features, including PSD elements, were assessed by subgroup analysis (Cochran Q test). Risk of bias was assessed using the Cochrane Risk of Bias 2 tool for RCTs and the National Institutes of Health Quality Assessment Tool for pre-post studies. Results: A total of 40 (0.47%) publications out of 8520 met the inclusion criteria of this review, representing 6611 participants. Studies comprised examinations of 38 unique interventions, of which 32 (84%) were RCTs. Synthesis found that included interventions had the following transdiagnostic treatment targets: severity of BPD symptoms (4/38, 11%), suicidal ideation (17/38, 45%), paranoia (5/38, 13%), nonsuicidal self-injury (5/38, 13%), emotion regulation (4/38, 11%), and anger (3/38, 8%). Common therapeutic approaches were based on dialectical behavioral therapy (8/38, 21%), cognitive behavioral therapy (6/38, 16%), or both (5/38, 13%). Meta-analysis found significant effects of digital intervention for both symptoms of paranoia (Hedges g=–0.52, 95% CI –0.86 to –0.18; P=.01) and suicidal ideation (Hedges g=–0.13, 95% CI –0.25 to –0.01; P=.03) but not overall BPD symptom severity (Hedges g=–0.17, 95% CI –0.42 to 0.10; P=.72). Subgroup analysis of suicidal ideation interventions found that evidence-based treatments such as cognitive behavioral therapy and dialectical behavior therapy were significantly more effective than alternative modalities (Cochran Q=4.87; P=.03). The degree of human support was not associated with the treatment effect. Interventions targeting suicidal ideation that used reminders, offered self-monitoring, and encouraged users to rehearse behaviors were associated with a greater reduction in ideation severity. Conclusions: Evidence suggests that digital interventions may reduce the symptoms of suicidal ideation and paranoia and that the design of digital interventions may impact the efficacy of treatments targeting suicidal ideation. These results support the use of transdiagnostic digital interventions for paranoia and suicidal ideation. Trial Registration: PROSPERO CRD42022358270; https://tinyurl.com/3mz7uc7k %R 10.2196/54941 %U https://www.jmir.org/2024/1/e54941 %U https://doi.org/10.2196/54941 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53157 %T A Smart Glass Telemedicine Application for Prehospital Communication: User-Centered Design Study %A Zhang,Zhan %A Bai,Enze %A Xu,Yincao %A Stepanian,Aram %A Kutzin,Jared M %A Adelgais,Kathleen %A Ozkaynak,Mustafa %+ School of Computer Science and Information Systems, Pace University, 1 Pace Plaza, New York, NY, 10038, United States, 1 3153992627, zzhang@pace.edu %K smart glass %K telemedicine %K participatory design %K emergency medical service %K health care %K prehospital care %K mobile health %K mHealth %K augmented reality %D 2024 %7 29.11.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Smart glasses have emerged as a promising solution for enhancing communication and care coordination among distributed medical teams. While prior research has explored the feasibility of using smart glasses to improve prehospital communication between emergency medical service (EMS) providers and remote physicians, a research gap remains in understanding the specific requirements and needs of EMS providers for smart glass implementation. Objective: This study aims to iteratively design and evaluate a smart glass application tailored for prehospital communication by actively involving prospective users in the system design process. Methods: Grounded in participatory design, the study consisted of 2 phases of design requirement gathering, rapid prototyping, usability testing, and prototype refinement. In total, 43 distinct EMS providers with diverse backgrounds participated in this 2-year long iterative design process. All qualitative data (eg, transcribed interviews and discussions) were iteratively coded and analyzed by at least 2 researchers using thematic analysis. Quantitative data, such as System Usability Scale (SUS) scores and feature ratings, were analyzed using statistical methods. Results: Our research identified challenges in 2 essential prehospital communication activities: contacting online medical control (OLMC) physicians for medical guidance and notifying receiving hospital teams of incoming patients. The iterative design process led to the identification of 5 key features that could potentially address the identified challenges: video call functionality with OLMC physicians, call priority indication for expedited OLMC contact, direct communication with receiving hospitals, multimedia patient information sharing, and touchless interaction methods for operating the smart glasses. The SUS score for our system design improved from a mean of 74.3 (SD 11.3) in the first phase (classified as good usability) to 80.3 (SD 13.1) in the second phase (classified as excellent usability). This improvement, along with consistently high ratings for other aspects (eg, willingness to use and feature design), demonstrated continuous enhancement of the system’s design across the 2 phases. Additionally, significant differences in SUS scores were observed between EMS providers in urban areas (median 85, IQR 76-94) and rural areas (median 72.5, IQR 66-83; Mann-Whitney U=43; P=.17), as well as between paramedics (median 72.5, IQR 70-80) and emergency medical technicians (median 85, IQR: 74-98; Mann-Whitney U=44.5; P=.13), suggesting that EMS providers in urban settings and those with less training in treating patients in critical conditions perceived the smart glass application as more useful and user-friendly. Finally, the study also identified several concerns regarding the adoption of the smart glass application, including technical limitations, environmental constraints, and potential barriers to workflow integration. Conclusions: Using a participatory design approach, this study provided insights into designing user-friendly smart glasses that address the current challenges EMS providers face in dynamic prehospital settings. %M 39612486 %R 10.2196/53157 %U https://www.jmir.org/2024/1/e53157 %U https://doi.org/10.2196/53157 %U http://www.ncbi.nlm.nih.gov/pubmed/39612486 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e55736 %T Biomarkers of Response to Internet-Based Psychological Interventions: Systematic Review %A Gotti,Giulia %A Gabelli,Chiara %A Russotto,Sophia %A Madeddu,Fabio %A Courtet,Philippe %A Lopez-Castroman,Jorge %A Zeppegno,Patrizia %A Gramaglia,Carla Maria %A Calati,Raffaella %+ Department of Psychology, University of Milan-Bicocca, Piazza dell'Ateneo Nuovo 1, U6 Building, Room 3129, Milan, 20126, Italy, 39 3477752087, raffaella.calati@unimib.it %K biomarker %K cognitive behavioral therapy %K internet-based intervention %K systematic review %K psychological intervention %K mental health intervention %K meta analysis %K psychiatric %K blood glucose %K mindfulness %K stress management %K immune response %K smoking %K cortisol %D 2024 %7 29.11.2024 %9 Review %J J Med Internet Res %G English %X Background: Internet-based psychological interventions provide accessible care to a wide range of users, overcoming some obstacles—such as distance, costs, and safety—that might discourage seeking help for mental issues. It is well known that psychological treatments and programs affect the body, as well as the mind, producing physiological changes that ought to be considered when assessing the efficacy of the intervention. However, the literature investigating changes in biomarkers specifically after internet-based psychological and mental health interventions has not yet extensively inquired into this topic. Objective: This systematic review aims to provide a synthesis of literature examining the effects of internet-based psychological interventions—targeting both clinical (mental and physical) and nonclinical conditions—on biomarkers. A secondary aim was to evaluate whether the biomarkers’ variations were related to a complementary modification of the psychological or physical symptoms or to a general improvement of the participants’ well-being. Methods: This review was conducted according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) statement. A literature search was performed through 3 databases (PubMed, PsycINFO, and Scopus). Studies examining changes in biomarkers before and after internet-based psychological interventions or programs targeting both clinical and nonclinical samples were included, with no exclusion criteria concerning mental or physical conditions. Results: A total of 24 studies fulfilled the inclusion criteria. These studies involved individuals with psychiatric or psychological problems (n=6, 25%), those with organic or medical diseases (n=10, 42%), and nonclinical populations (n=8, 33%). Concerning psychiatric or psychological problems, cognitive behavioral therapy (CBT) and CBT-informed interventions showed partial effectiveness in decreasing glycated hemoglobin blood glucose level (n=1) and chemokines (n=1) and in increasing connectivity between the default-mode network and the premotor or dorsolateral prefrontal cortex (n=1). Among individuals with organic or medical diseases, studies reported a significant change in cardiac or cardiovascular (n=3), inflammatory (n=2), cortisol (n=2), glycated hemoglobin (n=2), and immune response (n=1) biomarkers after CBT and CBT-informed interventions, and mindfulness and stress management interventions. Lastly, mindfulness, CBT and CBT-informed interventions, and music therapy succeeded in modifying immune response (n=2), cortisol (n=1), α amylase (n=1), posterior cingulate cortex reactivity to smoking cues (n=1), and carbon monoxide (n=1) levels in nonclinical populations. In some of the included studies (n=5), the psychological intervention or program also produced an improvement of the mental or physical condition of the participants or of their general well-being, alongside significant variations in biomarkers; CBT and CBT-informed interventions proved effective in reducing both psychological (n=2) and physical symptoms (n=2), while a mindfulness program successfully lowered cigarette consumption in a nonclinical sample (n=1). Conclusions: Although further evidence is required, we hope to raise awareness on the potential impact of internet-based interventions on biomarkers related to mental and physical health. %M 39612489 %R 10.2196/55736 %U https://www.jmir.org/2024/1/e55736 %U https://doi.org/10.2196/55736 %U http://www.ncbi.nlm.nih.gov/pubmed/39612489 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e57205 %T Messenger App–Based Information Provision for Promoting Social Participation to Enhance Well-Being Among Community-Dwelling Adults: Randomized Controlled Trial %A Nakagomi,Atsushi %A Abe,Noriyuki %A Chen,Yu-Ru %A Ide,Kazushige %A Kobayashi,Shuhei %A Hanazato,Masamichi %A Kondo,Katsunori %+ Center for Preventive Medical Sciences, Chiba University, 1-33 Yayoicho, Inage Ward, Chiba, 263-8522, Japan, 81 43 251 1111, anakagomi0211@gmail.com %K messenger app %K event information %K happiness %K social participation %K messenger %K app %K well-being %K adults %K aging %K randomized controlled trial %K RCT %K information technology %K social activity %K Japan %K urban community %K health information %K control group %K multivariable regression %K life satisfaction %K digital intervention %K community-dwelling %D 2024 %7 29.11.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Engaging in social activities, interacting with peers, and participating in community events may promote health and well-being. Recently, interventions leveraging information and communications technology have emerged as potent tools for promoting social connections and well-being. Particularly, messenger apps have become an integral part of our daily lives, facilitating communication, information dissemination, and social interaction. However, there remains a gap in the literature regarding the utilization of widely adopted messenger apps for this purpose. Objective: This study aimed to evaluate the impact of messenger app–based information provision aimed at promoting social participation on the enhancement of subjective well-being among Japanese community-dwelling adults. Methods: A 2-arm, parallel-group randomized controlled trial was conducted from October 2022 to January 2023 in the Kashiwa-no-ha campus area, Japan—an urban community with active local events. A total of 358 community-dwelling adults who use messenger apps daily were recruited for the study. Of these, 235 (65.6%) participants completed the follow-up survey. Participants were randomly assigned to either the intervention group, receiving the health benefits of social participation and information about local events or spots via a messenger app, or the control group, receiving general health information. The primary outcome was subjective happiness after the intervention, measured on an 11-point scale ranging from 0 (Unhappy) to 10 (Happy). Secondary outcomes included life satisfaction, meaning of life, purpose in life, and participation in local events. The outcomes were analyzed with t tests (2-tailed) and multivariable regression based on the intention-to-treat method. Results: After the intervention, the intervention group reported a mean happiness score of 7.7 (SD 1.7), while the control group reported a score of 7.5 (SD 2.0), with no statistically significant difference (P=.40). Multivariable linear regression analysis adjusted for baseline outcome values and covariates showed that the coefficient of the intervention for life satisfaction was 0.30 (95% CI –0.07 to 0.68; P=.12), while that for meaning of life was 0.33 (95% CI –0.03 to 0.70; P=.07). There was no significant difference in event participation rates between the 2 groups during the study period (P=.22). However, 82.2% (102/124) of the intervention group acknowledged the utility of the event information provided. Conclusions: Messenger app–based information provision did not yield a significant increase in subjective happiness, while there was a positive but not significant trend in life satisfaction. The findings underscore the need for more intensive intervention in future studies to harness the potential of digital interventions. Trial Registration: UMIN Clinical Trials Registry UMIN000049047; https://tinyurl.com/2zzrrae8 %M 39612209 %R 10.2196/57205 %U https://www.jmir.org/2024/1/e57205 %U https://doi.org/10.2196/57205 %U http://www.ncbi.nlm.nih.gov/pubmed/39612209 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e63743 %T Digital Health Interventions for Informal Family Caregivers of People With First-Episode Psychosis: Systematic Review on User Experience and Effectiveness %A Münchenberg,Pauline Sarah %A Yessimova,Dinara %A Panteli,Dimitra %A Kurth,Tobias %+ Institute of Public Health, Charité – Universitätsmedizin Berlin, Charitéplatz 1, Berlin, 10117, Germany, 49 30 450570872, pauline.muenchenberg@charite.de %K first-episode psychosis %K early psychosis %K digital health interventions %K telepsychiatry %K informal caregivers %K family caregivers %K telehealth %K severe mental disorders %K psychosis %K digital intervention %K digital health %K mental health %K psychoeducation %K mobile phone %D 2024 %7 28.11.2024 %9 Review %J JMIR Ment Health %G English %X Background: First-episode psychosis (FEP) imposes a substantial burden not only on the individual affected but also on their families. Given that FEP usually occurs during adolescence, families overtake a big part of informal care. Early family interventions, especially psychoeducation, are crucial for informal family caregivers to best support the recovery of their loved one with FEP and to reduce the risk of a psychotic relapse as much as possible, but also to avoid chronic stress within the family due to the burden of care. Digital health interventions offer the possibility to access help quicker, use less resources, and improve informal family caregiver outcomes, for example, by reducing stress and improving caregiver quality of life. Objective: This study aimed to systematically identify studies on digital health interventions for informal family caregivers of people with FEP and to describe and synthesize the available literature on user experience, as well as the effectiveness of such digital applications on the clinical outcomes, consisting of (1) perceived caregiver stress, (2) expressed emotion, and (3) parental self-efficacy. Methods: A systematic search was carried out across 4 electronic databases. In addition, reference lists of relevant studies were hand-searched. This review aimed to include only primary studies on informal family caregivers, who had to care for a person with FEP between 15 years and 40 years of age and a diagnosis of FEP with onset of observed symptoms within the past 5 years. All types of digital interventions were included. This systematic review is aligned with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) 2020 guidelines. Results: The search identified 7 studies that reported on user experience or effectiveness of digital health interventions on perceived caregiver stress, expressed emotion, and parental self-efficacy, including 377 informal family FEP caregivers across trials. Digital health interventions–web-based, videoconferences, and mHealth–were well accepted and perceived as relevant, easy to use, and helpful by informal family FEP caregivers. Psychoeducational content was rated as the most important across studies. Perceived caregiver stress, expressed emotion, and parental self-efficacy improved in all studies that reported on these clinical outcomes. Conclusions: The results of this review suggest that digital health interventions aimed at informal family caregivers of individuals with FEP can improve relevant clinical outcomes, with participants reporting a positive user experience. However, for some interventions reviewed, specialized in-person family care outperformed the digital intervention and partially led to better results in perceived caregiver stress and parental self-efficacy. Therefore, while digital interventions present a promising approach to alleviate the burden of care and improve informal family FEP caregiver outcomes, more studies with well-powered experimental designs are needed to further investigate the effectiveness of such applications in this population. Trial Registration: PROSPERO CRD42024536715; https://tinyurl.com/bdd3u7v9 %M 39607998 %R 10.2196/63743 %U https://mental.jmir.org/2024/1/e63743 %U https://doi.org/10.2196/63743 %U http://www.ncbi.nlm.nih.gov/pubmed/39607998 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e49305 %T Internet-Delivered Psychoeducation (SCOPE) for Transition-Aged Autistic Youth: Pragmatic Randomized Controlled Trial %A Backman,Anna %A Roll-Pettersson,Lise %A Mellblom,Are %A Norman-Claesson,Elisabet %A Sundqvist,Emma %A Zander,Eric %A Vigerland,Sarah %A Hirvikoski,Tatja %+ Socialstyrelsen, National Board of Health and Welfare, Rålambsvägen 3, Stockholm, SE 106 30, Sweden, 46 732445857, anna.n.backman@hotmail.com %K autism %K internet based %K young adult %K intervention %K digital communication %K life satisfaction %K codeveloped %K ASD %K autism spectrum disorder %K autistic %K RCT %K randomized controlled trial %K randomized %K psychoeducation %K patient education %D 2024 %7 28.11.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Psychoeducation is a recommended first-line intervention for transition-aged autistic youth, but it has not been previously evaluated in an internet-delivered format. SCOPE (Spectrum Computerized Psychoeducation) is an 8-week individual, internet-delivered, therapist-supported psychoeducative intervention. Objective: This study aimed to investigate the effectiveness of SCOPE through a 3-armed randomized controlled trial. The intervention aims to increase participants’ understanding of autism and, in doing so, increase their quality of life (QoL). Methods: SCOPE was codeveloped with clinicians and autistic young adults. It contains 8 autism-related modules, each with (1) text describing the module topic, (2) four video vignettes with recurring characters who describe their lives and perspectives on the module topic, (3) a list of neurotypical characteristics related to the module’s topic, and (4) self-reflection using 3 or 4 questions about the module topic, answered by multiple-choice bullets and voluntary open-ended written comments. Participants were randomized (2:1:1) to SCOPE, an active control (web-based self-study), or treatment as usual (TAU). The primary outcome was participants’ autism knowledge, assessed using the Autism Spectrum Disorder Quiz, and secondary outcomes included acceptance of diagnosis, QoL, and symptoms of mental health problems. All outcomes were assessed at the baseline, postintervention, and 3-month follow-up time points, using mixed-effects models to assess change in outcome measures across time points. Results: Between 2014 and 2020, a total of 141 participants were randomized to 1 of the 3 treatment arms. The SCOPE participants had significantly greater autism knowledge gains at the posttreatment time point compared to TAU participants with a moderate effect size (d=0.47; P=.05); gains were maintained at the 3-month follow-up (d=0.46; P=.05). The self-study participants also had increased knowledge gains compared to TAU participants at the posttreatment time point with a moderate effect size (d=0.60; P=.03) but did not maintain these gains at the 3-month follow-up, and their autism knowledge scores returned to baseline (mean change score: –0.13, 95% CI –1.20 to 0.94; P=.81). In addition, SCOPE participants reported improved QoL at the postintervention (d=0.37, P=.02) and 3-month follow-up time points (d=0.60; P=.001), compared to the combined controls. The gained autism knowledge was not mirrored by changes in symptoms of anxiety or depression. Conclusions: Effective internet-delivered interventions may facilitate first-line service access to individuals who are unable or unwilling to use traditional health care interventions or who live in geographically remote locations. Additionally, an intervention such as SCOPE could impart and sustain the knowledge gained through psychoeducation in transition-aged autistic youth. For future research, qualitative studies could further our understanding of the lived experiences of intervention participation and outcomes after internet-delivered psychoeducation. Trial Registration: ClinicalTrials.gov NCT03665363; https://clinicaltrials.gov/study/NCT03665363 %R 10.2196/49305 %U https://www.jmir.org/2024/1/e49305 %U https://doi.org/10.2196/49305 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e54248 %T Predicting Early Dropout in a Digital Tobacco Cessation Intervention: Replication and Extension Study %A Yu,Linda Q %A Amato,Michael S %A Papandonatos,George D %A Cha,Sarah %A Graham,Amanda L %+ Innovations Center, Truth Initiative, 900 G St NW Fourth Floor, Washington, DC, 20001, United States, 1 2024545938, agraham@truthinitiative.org %K digital interventions %K attrition %K engagement %K dropout %K tobacco %K smoking %K cessation %K mobile health %K internet %K mobile phone %D 2024 %7 27.11.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Detecting early dropout from digital interventions is crucial for developing strategies to enhance user retention and improve health-related behavioral outcomes. Bricker and colleagues proposed a single metric that accurately predicted early dropout from 4 digital tobacco cessation interventions based on log-in data in the initial week after registration. Generalization of this method to additional interventions and modalities would strengthen confidence in the approach and facilitate additional research drawing on it to increase user retention. Objective: This study had two research questions (RQ): RQ1—can the study by Bricker and colleagues be replicated using data from a large-scale observational, multimodal intervention to predict early dropout? and RQ2—can first-week engagement patterns identify users at the greatest risk for early dropout, to inform development of potential “rescue” interventions? Methods: Data from web users were drawn from EX, a freely available, multimodal digital intervention for tobacco cessation (N=70,265). First-week engagement was operationalized as any website page views or SMS text message responses within 1 week after registration. Early dropout was defined as having no subsequent engagement after that initial week through 1 year. First, a multivariate regression model was used to predict early dropout. Model predictors were dichotomous measures of engagement in each of the initial 6 days (days 2-7) following registration (day 1). Next, 6 univariate regression models were compared in terms of their discrimination ability to predict early dropout. The sole predictor of each model was a dichotomous measure of whether users had reengaged with the intervention by a particular day of the first week (calculated separately for each of 2-7 days). Results: For RQ1, the area under the receiver operating characteristic curve (AUC) of the multivariate model in predicting dropout after 1 week was 0.72 (95% CI 0.71-0.73), which was within the range of AUC metrics found in the study by Bricker and colleagues. For RQ2, the AUCs of the univariate models increased with each successive day until day 4 (0.66, 95% CI 0.65-0.67). The sensitivity of the models decreased (range 0.79-0.59) and the specificity increased (range 0.48-0.73) with each successive day. Conclusions: This study provides independent validation of the use of first-week engagement to predict early dropout, demonstrating that the method generalizes across intervention modalities and engagement metrics. As digital intervention researchers continue to address the challenges of low engagement and early dropout, these results suggest that first-week engagement is a useful construct with predictive validity that is robust across interventions and definitions. Future research should explore the applicability and efficiency of this model to develop interventions to increase retention and improve health behavioral outcomes. %M 39602788 %R 10.2196/54248 %U https://www.jmir.org/2024/1/e54248 %U https://doi.org/10.2196/54248 %U http://www.ncbi.nlm.nih.gov/pubmed/39602788 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e59684 %T The Digital Divide and Cognitive Disparities Among Older Adults: Community-Based Cohort Study in China %A Li,Yumeng %A Liu,Chen %A Sun,Jiaqing %A Zhang,Junying %A Li,Xin %A Zhang,Zhanjun %+ State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University, Xinjiekouwai Street No 19, Beijing, 100875, China, 86 010 58802882, lixin99@bnu.edu.cn %K digital divide %K internet use %K cognitive aging %K mild cognitive impairment %K socioeconomic status %K resource inequality %K cognitive disparities %K cognitive function %K elderly %K older adult %K aging %K community-based %K cohort study %K China %K ANCOVA %K mixed linear model %K Cox proportional hazards %K mental health %K internet %K digital health %K information and communication technologies %K ICT %K mHealth %D 2024 %7 27.11.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: The widespread adoption of information and communication technologies (ICTs) further deepens disparities in resource access, particularly among the aging population. However, the relationship between these factors and their resulting impact on cognitive abilities remains uncertain. Objective: This study aims to investigate the potential impact of the digital divide on individuals’ cognitive function and its association with the development and reversion of mild cognitive impairment (MCI). Methods: This cohort study used data from Beijing Aging Brain Rejuvenation (BABRI) study applying a multistage cluster sampling design between 2008 and 2020. The digital divide was quantified by the frequency of using ICTs. Analysis of covariance (ANCOVA), mixed linear models, and Cox proportional hazards models were used to model the association of digital divide and multidomain cognition. Results: Among the 10098 participants, nearly half (n=4941, 48.9%) faced the digital divide, which was associated with a worse performance in processing speed (F10096=10.67; P<.001; effect size r=0.42), rather than memory, executive function, and language. The model indicated that individuals’ physical and mental health, combined with their educational and occupational prestige, influenced the resources they attained, which ultimately caused the digital divide. Moreover, longitudinal data revealed that older adults who successfully crossed the digital divide during the tracking process and those who had already done so prior to tracking showed significantly slower rates of decline in processing speed (B=–1.98, P<.05; B=–2.62, P<.01) and general cognitive function (B=3.50, P<.001; B=3.13, P<.01). Additionally, overcoming the digital divide was also associated with a lower risk of developing MCI (hazard ratio [HR] 0.5, 95% CI 0.34-0.74; HR 0.43, 95% CI 0.29-0.62) and a greater probability of reversion from MCI to normal cognition (HR 6, 95% CI 3.77-9.56; HR 9.22, 95% CI 5.63-15.11). Conclusions: Overcoming the digital divide was significantly associated with improved cognitive function, a slower aging rate in cognitive performance, a reduced risk of developing MCI, and a higher likelihood of reverting from MCI to normal cognition. %M 39602795 %R 10.2196/59684 %U https://www.jmir.org/2024/1/e59684 %U https://doi.org/10.2196/59684 %U http://www.ncbi.nlm.nih.gov/pubmed/39602795 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e59145 %T Effects of a Digital Therapeutic Adjunct to Eating Disorder Treatment on Health Care Service Utilization and Clinical Outcomes: Retrospective Observational Study Using Electronic Health Records %A Palacios,Jorge E %A Erickson-Ridout,Kathryn K %A Paik Kim,Jane %A Buttlaire,Stuart %A Ridout,Samuel %A Argue,Stuart %A Tregarthen,Jenna %+ Bright Therapeutics, 304 Moultrie St, San Francisco, CA, 94110, United States, 1 6504047098, jorge.palacios@brighttherapeutics.com %K digital therapeutics %K app-augmented therapy %K eating disorders %K health care utilization %K costs %K real-world data %K depression %K emergency department %K outpatient care %K eating %K treatment %K therapy %K retrospective analysis %K electronic health record %K patient %K app %K outpatient %D 2024 %7 27.11.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: The need for scalable solutions facilitating access to eating disorder (ED) treatment services that are efficient, effective, and inclusive is a major public health priority. Remote access to synchronous and asynchronous support delivered via health apps has shown promise, but results are so far mixed, and there are limited data on whether apps can enhance health care utilization. Objective: This study aims to examine the effects of app-augmented treatment on clinical outcomes and health care utilization for patients receiving treatment for an ED in outpatient and intensive outpatient levels of care. Methods: Recovery Record was implemented in outpatient and intensive outpatient services in a California-based health maintenance organization. We examined outcomes for eligible patients with ED by comparing clinical and service utilization medical record data over a 6-month period after implementation with analogous data for the control group in the year prior. We used a logistic regression model and inverse-weighted estimates of the probability of treatment to adjust for treatment selection bias. Results: App-augmented treatment was associated with a significant decrease in emergency department visits (P<.001) and a significant increase in outpatient treatment utilization (P<.001). There was a significantly larger weight gain for patients in low-weight categories (ie, underweight, those with anorexia, or those with severe anorexia) with app-augmented treatment (treatment effect: 0.74, 0.25, and 0.35, respectively; P=.02), with a greater percentage of patients moving into a higher BMI class (P=.01). Conclusions: Integrating remote patient engagement apps into ED treatment plans can have beneficial effects on both clinical outcomes and service utilization. More research should be undertaken on long-term efficacy and cost-effectiveness to further explore the impact of digital health interventions in ED care. %M 39602804 %R 10.2196/59145 %U https://mental.jmir.org/2024/1/e59145 %U https://doi.org/10.2196/59145 %U http://www.ncbi.nlm.nih.gov/pubmed/39602804 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e63732 %T A Personalized, Transdiagnostic Smartphone App (Mello) Targeting Repetitive Negative Thinking for Depression and Anxiety: Qualitative Analysis of Young People’s Experience %A Valentine,Lee %A Arnold,Chelsea %A Nicholas,Jennifer %A Castagnini,Emily %A Malouf,Jessi %A Alvarez-Jimenez,Mario %A Bell,Imogen H %+ Orygen, 35 Poplar Rd, Melbourne, 3052, Australia, 61 9966 9100, lee.valentine@orygen.org.au %K repetitive negative thinking %K rumination %K anxiety %K depression %K mobile app %K just-in-time adaptive interventions %K youth mental health %K adolescent %K mobile phone %D 2024 %7 27.11.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: The increasing rates of mental health challenges among young people highlight an urgent need for accessible and effective treatment. However, current mental health systems face unprecedented demand, leaving most young people globally with unmet mental health needs. Smartphones present a promising solution to this issue by offering in-the-moment support through innovative just-in-time adaptive interventions, which provide support based on real-time data. Objective: This study explores young people’s experiences with Mello, a just-in-time adaptive intervention that focuses on the transdiagnostic mechanism of repetitive negative thinking (RNT), a significant factor contributing to youth depression and anxiety. Methods: Semistructured qualitative interviews were conducted with 15 participants aged 16 to 25 years, all of whom had previously participated in a pilot randomized controlled trial of Mello. Of the 15 participants, 9 (60%) identified as women, 4 (27%) as men (including 1 transgender man), and 2 (13%) as nonbinary. Interviews focused on participants’ experiences with the Mello app, factors influencing engagement, perceived benefits and limitations, and suggestions for future improvements. Thematic analysis was used to analyze the data. Results: The analysis identified three superordinate themes: Mello as a tool for intentional reflection; doing therapy your own way; and barriers to engagement during low mood, anxiety, and RNT. Theme 1 explored young people’s experiences of how the app facilitated active management of negative thoughts and supported the development of reflective habits, contrasting with their typical strategies of avoidance or resistance. Theme 2 highlighted the value of the app’s self-guided nature, with a particular focus on its flexibility and accessibility, particularly when compared to traditional face-to-face therapy. Finally, theme 3 addressed barriers to engagement, particularly during emotionally difficult times, with participants reporting feeling “stuck” in their negative thoughts. To mitigate these challenges, participants suggested incorporating gamification elements, such as progress-tracking visuals, to enhance motivation and increase engagement with the app. Conclusions: Our findings underscored the value of Mello in promoting intentional engagement and reflection with RNT, consistent with prior research that emphasizes the effectiveness of tailored interventions. Although some users valued the self-guided nature of the application, others encountered difficulties with motivation. Future research should explore strategies to enhance engagement for young people with low mood and motivation, such as co-design methodologies, advanced personalization features, and gamification techniques. %M 39602793 %R 10.2196/63732 %U https://www.jmir.org/2024/1/e63732 %U https://doi.org/10.2196/63732 %U http://www.ncbi.nlm.nih.gov/pubmed/39602793 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e63234 %T Effectiveness of a Novel Web-Based Intervention to Enhance Therapeutic Relationships and Treatment Outcomes in Adult Individual Psychotherapy: Randomized Controlled Trial and Analysis of Predictors of Dropouts %A Stefana,Alberto %A Fusar-Poli,Paolo %A Vieta,Eduard %A Youngstrom,Eric A %+ Department of Brain and Behavioral Sciences, University of Pavia, Via Forlanini 14, Pavia, 27100, Italy, 39 0382987537, alberto.stefana@gmail.com %K therapeutic relationship %K real relationship %K routine outcome monitoring %K measurement-based care %K patient-focused research %K psychotherapy process %K randomized controlled trial %K RCT %K psychotherapy %K assessment %K mental health %K digital mental health %K eHealth %K self monitoring %K outcomes research %K digital health %K health intervention %K therapy %D 2024 %7 27.11.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Routine process and outcome monitoring interventions added to psychotherapy are known to improve treatment outcomes, although they vary in format and effectiveness. Objective: This study aimed to evaluate whether a therapist-independent, internet-based routine process monitoring and feedback system could significantly reduce psychological distress and enhance the quality of the therapeutic relationship compared with a treatment-as-usual control group among individuals already engaged in individual psychotherapy. Methods: We randomized 475 participants into either the intervention group, which received access to an internet-based routine process monitoring and feedback system in addition to psychotherapy, or the control group, which received only psychotherapy. The trial lasted for 10 weeks. Follow-up assessments at 5 weeks and 10 weeks used the Clinical Outcomes in Routine Evaluation-Outcome Measure as the primary outcome, with the Working Alliance Inventory-Short Revised and the Real Relationship Inventory-Client form as secondary outcomes. Results: Per-protocol analyses (n=166) showed that psychological distress decreased in both groups, but there was no significant advantage for the intervention group. The intervention group experienced a decline in the genuineness dimension score of the real relationship, with an effect size of d=–0.27, compared with d=0.01 in the control group. In the intervention group (but not in the control group), dropouts showed significantly lower real relationship levels (P=.002), working alliance quality (P=.051), and emotional disclosure (P=.01) compared with those who completed the study. Additionally, logistic regression revealed distinct predictors of dropout within the control group and intervention group. Conclusions: The findings do not provide conclusive evidence for the efficacy of the new internet-based intervention in enhancing self-monitoring and prompting reflection on patients’ emotional responses to their therapists. However, the intervention appears to influence patients’ perceptions of the genuineness dimension in the therapeutic relationship, warranting further investigation. We hypothesize that this alteration in the genuineness dimension could be attributed to the intervention facilitating a more realistic and accurate perception of the therapeutic relationship among participants. Trial Registration: ClinicalTrials.gov NCT06038747; https://clinicaltrials.gov/study/NCT06038747 International Registered Report Identifier (IRRID): RR2-10.2196/55369 %M 39602203 %R 10.2196/63234 %U https://mental.jmir.org/2024/1/e63234 %U https://doi.org/10.2196/63234 %U http://www.ncbi.nlm.nih.gov/pubmed/39602203 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e57579 %T Feasibility of a Web-Based and Mobile-Supported Follow-Up Treatment Pathway for Adult Patients With Orthopedic Trauma in the Netherlands: Concurrent Mixed Methods Study %A Willinge,Gijs J A %A Spierings,Jelle F %A Romijnders,Kim A G J %A Mathijssen,Elke G E %A Twigt,Bas A %A Goslings,J Carel %A van Veen,Ruben N %K musculoskeletal extremity injury %K patient portal %K follow-up treatment %K healthcare utilization %K patient experience %K feasibility %K orthopedics %K trauma %K Netherlands %K mixed methods %K resource utilization %K electronic patient records %K thematic analysis %K qualitative data %K digital treatment %K mobile phone %D 2024 %7 26.11.2024 %9 %J JMIR Form Res %G English %X Background: Orthopedic trauma care encounters challenges in follow-up treatment due to limited patient information provision, treatment variation, and the chaotic settings in which it is provided. Additionally, pressure on health care resources is rising worldwide. In response, digital follow-up treatment pathways were implemented for patients with orthopedic trauma, aiming to optimize health care resource use and enhance patient experiences. Objective: We aim to assess digital follow-up treatment pathway feasibility from the patient’s perspective and its impact on health care resource use. Methods: A concurrent mixed methods study was conducted parallel to implementation of digital follow-up treatment pathways in an urban level-2 trauma center. Inclusion criteria were (1) minimum age of 18 years, (2) an active web-based patient portal account, (3) ability to read and write in Dutch, and (4) no cognitive or preexisting motor impairment. Data were collected via electronic patient records, and surveys at three time points: day 1‐3, 4‐6 weeks, and 10‐12 weeks after an initial emergency department visit. Semistructured interviews were performed at 10‐12 weeks post injury. Anonymous data from a pre-existing database were used to compare health care resource use between the digital treatment pathways and traditional treatment. Quantitative data were reported descriptively. A thematic analysis was used for qualitative data. All outcomes were categorized according to the Bowen feasibility parameters: acceptability, demand, implementation, integration, and limited efficacy. Results: Sixty-six patients were included for quantitative data collection. Survey response rates were 100% (66/66) at day 1‐3, 92% (61/66) at 4‐6 weeks, and 79% (52/66) at 10‐12 weeks. For qualitative data collection, 15 semistructured interviews were performed. Patients reported median satisfaction scores of 7 (IQR 6‐8) with digital treatment pathways and 8 (IQR 7‐9) for overall treatment, reflecting positive experiences regarding functionality, actual and intended use, and treatment safety. Digital treatment pathways reduced secondary health care use, with fewer follow-up appointments by phone (median 0, IQR 0‐0) versus the control group (median 1, IQR 0‐1; P<.001). Consequently, fewer physicians were involved in follow-up treatment for the intervention group (median 2, IQR 1‐2) than for the control group (median 2, IQR 1‐3; P<.001). Fewer radiographs were performed for the intervention group (median 1, IQR 0-1) than for the control group (P=.01). Qualitative data highlighted positive experiences with functionalities, intended use, and safety, but also identified areas for improvement, including managing patient expectations, platform usability, and protocol adherence. Conclusions: Use of digital follow-up treatment pathways is feasible, yielding satisfactory patient experiences and reducing health care resource use. Recommendations for improvement include early stakeholder involvement, integration of specialized digital tools within electronic health record systems, and hands-on training for health care professionals. These insights can guide clinicians and policy makers in effectively integrating similar tools into clinical practice. %R 10.2196/57579 %U https://formative.jmir.org/2024/1/e57579 %U https://doi.org/10.2196/57579 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e52266 %T Impact of an mHealth App (Kencom) on Patients With Untreated Hypertension Initiating Antihypertensive Medications: Real-World Cohort Study %A Matsumura,Koichiro %A Nakagomi,Atsushi %A Yagi,Eijiro %A Yamada,Nobuhiro %A Funauchi,Yohei %A Kakehi,Kazuyoshi %A Yoshida,Ayano %A Kawamura,Takayuki %A Ueno,Masafumi %A Nakazawa,Gaku %A Tabuchi,Takahiro %K untreated hypertension %K mobile health app %K antihypertensive medication %K cardiovascular disease %K mHealth %D 2024 %7 26.11.2024 %9 %J JMIR Cardio %G English %X Background: To prevent the further development of cardiovascular diseases, it is a growing global priority to detect untreated hypertension in patients and ensure adequate blood pressure control via drug therapy. However, few effective tools that facilitate the initiation of antihypertensive medications among such patients have been identified. Objective: We aimed to determine whether a mobile health (mHealth) app facilitates the initiation of antihypertensive medications among patients with untreated hypertension. Methods: We analyzed a large longitudinal integrated database mainly comprised of data from middle-aged, employed people and their families. The database contained data from health checkups, health insurance claims, and the mHealth app kencom. kencom is used to manage daily life logs (eg, weight, number of steps) and to provide health information tailored to customers. Patients with untreated hypertension were identified using the baseline health checkup data, and follow-up health checkups were conducted to identify the rate of initiation of antihypertensive medications between mHealth app users and nonusers. Antihypertensive medication status was confirmed via a questionnaire administered during the medical checkup as well as a review of the health insurance claims database. We conducted a modified Poisson regression analysis, weighted by inverse probability of treatment weighting, to examine the effect of mHealth app usage on the initiation of antihypertensive medications. Additionally, data from four lifestyle questionnaires from the baseline and follow-up health checkups were collected to evaluate lifestyle modifications that could be attributed to the mHealth app. Results: Data were collected from 50,803 eligible patients (mean age 49, SD 9 years; men n=39,412, 77.6%; women n=11,391, 22.4%) with a median follow-up period of 3.0 (IQR 2.3‐3.1) years. The rate of initiation of antihypertensive medications was significantly higher in the mHealth app user group than in the nonuser group: 23.4% (3482/14,879) versus 18.5% (6646/35,924; P<.001), respectively. The risk ratio of mHealth app usage for initiated antihypertensive medications was 1.28 (95% CI 1.23‐1.33). Among those who did not intend to improve their lifestyle habits such as exercise and diet at baseline, the rate of lifestyle improvement at follow-up was compared between mHealth app users and nonusers, using data from the questionnaires; mHealth app users demonstrated a significantly higher rate of lifestyle changes than nonusers. Conclusions: For patients with untreated hypertension, the use of the mHealth app kencom, which was not dedicated to hypertension treatment, was associated with a higher initiation of antihypertensive medications. %R 10.2196/52266 %U https://cardio.jmir.org/2024/1/e52266 %U https://doi.org/10.2196/52266 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e56556 %T Usability and Effectiveness of eHealth and mHealth Interventions That Support Self-Management and Health Care Transition in Adolescents and Young Adults With Chronic Disease: Systematic Review %A Li,ZhiRu %A Lu,FangYan %A Wu,JingYun %A Bao,RuiJie %A Rao,YuXin %A Yang,Yun %A Wang,Huafen %+ Nursing Department, The First Affiliated Hospital, Zhejiang University School of Medicine, 79 Qingchun Road, Hangzhou, 310000, China, 86 13516805833, 2185015@zju.edu.cn %K eHealth %K mHealth %K mobile health %K chronic disease %K healthcare transition %K self-management %K adolescents %K young adults %K chronic illness %K systematic review %K digital health %K health education %K social support %K symptom tracking %K monitoring %K effectiveness %D 2024 %7 26.11.2024 %9 Review %J J Med Internet Res %G English %X Background: With advances in medical technologies, more children with chronic diseases are now living on into adulthood. The development of proficient self-management skills is essential for adolescents and young adults to transition from pediatric to adult health care services. An innovative way to improve the current care model and foster self-management skills could be through eHealth or mHealth (mobile health) interventions, in particular, when considering the rising ownership of digital technology by adolescents and young adults. Objective: This systematic review aimed to evaluate the features, acceptability, usability, engagement, and intervention efficacy of eHealth and mHealth interventions that support self-management and health care transition in adolescents and young adults with chronic disease. Methods: This review followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) reporting guidelines (registration number CRD42023378355). We systematically searched the MEDLINE complete, Embase, Cochrane Library, CINAHL complete, and ProQuest Health & Medical complete. We considered only articles published in or since 2019, as we aimed to extend the data collected by 2 previous systematic reviews. Results: A total of 16,752 studies were screened. After removing duplicates, 14,507 studies were excluded based on the title and abstract. Ultimately, 22 studies were included. The interventions ranged from simple text messages to complex interventions involving web-based games and engagement of health care providers, which were summarized into 6 themes: medication monitoring and reminders, symptom tracking and monitoring, management goal setting, knowledge education and self-management skills training, incentives and reinforcement, and communication. Most adolescents and young adults felt the eHealth and mHealth interventions were feasible, as they were convenient, easy to use, and accessible in the context of helping manage their health. However, user engagement was variable and presented a gradual decline in youth engagement with these apps over time. Barriers that prevent user engagement are diverse, such as time-consuming video uploads, noncontinuous access to a phone, reading literacy levels, language, and false impressions. Moreover, adolescents and young adults had different preferred styles of message delivery and functions, especially the engaging elements, disease-specific information, and opportunities to communicate with peers, health care providers, and app teams. Conclusions: There remains limited data about the effectiveness of eHealth and mHealth interventions facilitating the self-management and health care transition of adolescents and young adults with chronic diseases. Based on the available evidence, they were receptive to and interested in receiving information and managing their health using mobile apps or websites. Considering adolescents and young adults had different preferred styles of message delivery and features, to improve user engagement and provide focused interventions, it would be better to involve them early in the design process to identify their specific needs, as well as collaborate with health care providers and app teams to obtain suggestions. %M 39589770 %R 10.2196/56556 %U https://www.jmir.org/2024/1/e56556 %U https://doi.org/10.2196/56556 %U http://www.ncbi.nlm.nih.gov/pubmed/39589770 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e62742 %T Assessing the Usability and Effectiveness of an AI-Powered Telehealth Platform: Mixed Methods Study on the Perspectives of Patients and Providers %A Jain,Ekta %A Gupta,Srishti %A Yadav,Vandana %A Kachnowski,Stan %+ Healthcare Innovation and Technology Lab, Lasker Hall, 3960 Broadway, Room 501, New York, NY, 10032, United States, 1 (212) 543 0100, vyadav@hitlab.org %K usability study %K telemedicine %K web platform %K patient-provider feedback %K artificial intelligence %K AI triage %D 2024 %7 25.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Telemedicine has revolutionized health care by significantly enhancing accessibility and convenience, yet barriers remain, such as providers’ challenges with technology use. With advancements in telemedicine technologies, understanding the viewpoints of patients and providers is crucial for an effective and acceptable telemedicine service. This study reports the findings on the usability and effectiveness of the HelixVM artificial intelligence powered platform, analyzing key aspetcs like asynchronous health care, access, time efficiency, productivity, data exchange, security, privacy, and quality of care from patient and provider perspectives. Objective: This study aims to assess the usability and effectiveness of the HelixVM marketplace platform. Methods: We recruited 102 patients and 12 providers in a mixed methods study design involving surveys and in-depth structured interviews with a subset of the providers. The survey questionnaires are a modified version of the Telehealth Usability Questionnaire. We analyzed patient data using descriptive statistics and exploratory factor analysis to identify latent demographic patterns. For provider data, we used a deductive thematic analysis approach to identify key themes from the interviews and interpreted overall sentiments of the providers as negative, neutral, or positive. We also calculated percentages of different provider responses from the survey and interviews, where applicable. Results: Overall, 86.3% (88/102) of the patients reported satisfaction with HelixVM, and 89.2% (91/102) indicated that they would use the services again. A total of 91.1% (93/102) of the patients agreed that HelixVM improves access to health care and is an acceptable way to receive health care, and 98% (100/102) agreed it saves time. Chi-square tests demonstrated statistical significance for all survey questions (P<.001). The results from factor analysis show a higher propensity of middle-aged women, who had a fast-track encounter type, who self-reported a medium level of technology savviness, and who are residing in the South region of the United States rating the platform more positively. With regard to the providers, the thematic analysis identified themes of asynchronous medicine in terms of the accessibility and quality of care, time and productivity, integration within the workflow, data exchange, and artificial intelligence triage. Certain challenges regarding incomplete data in patient charts and its impact on provider time were cited. Suggestions for improvements included options to ensure the completeness of patient charts and better screening to ensure that only asynchronous, qualified patients are able to reach the provider. Conclusions: Overall, our study findings indicate a positive experience for patients and providers. The use of fast-track prescription was considered favorable compared to traditional telemedicine. Some concerns on data completeness, gaps, and accuracy exist. Suggestions are provided for improvement. This study adds to the knowledge base of existing literature and provides a detailed analysis of the real-world implementation of a telemedicine market-place platform. %M 39418632 %R 10.2196/62742 %U https://formative.jmir.org/2024/1/e62742 %U https://doi.org/10.2196/62742 %U http://www.ncbi.nlm.nih.gov/pubmed/39418632 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e64994 %T Indigenous Parents’ Perspectives of Factors That Facilitate or Impede Engagement in Internet-Based Parenting Support Programs: Interpretive Description Study %A Butt,Michelle L %A Willett,Ysabella Jayne %A Miller,Vicky %A Jacobs,Brenda %A Ferron,Era Mae %A Wright,Amy L %+ Lawrence Bloomberg Faculty of Nursing, University of Toronto, 155 College St, Toronto, ON, M5T 1P8, Canada, 1 416 978 0695, amyl.wright@utoronto.ca %K child %K parenting %K qualitative %K Indigenous health %K support programs %D 2024 %7 22.11.2024 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Parenting support programs enhance parents’ health and their child’s development. The COVID-19 pandemic necessitated the delivery of these programs over the internet. After the pandemic, internet-based programs are still preferred by some. Objective: We aimed to understand Indigenous parents’ experiences engaging in internet-based parenting support programs; thus, an interpretive description study was conducted. Methods: A total of 20 Indigenous (female, male, and Two-Spirit) parents of children aged <5 years participated in semistructured interviews; data underwent collaborative thematic analysis with Indigenous community partners informed by the Two-Eyed Seeing framework and ethical space. Results: Parents’ experiences were classified into five themes: (1) Purpose: Program Delivery and Content, (2) Belonging: Building Relationships and Connections, (3) Hope: Cultural Connection, (4) Meaning: New or Improved Parenting Skills and Mental Wellness, and (5) Recommendations for Organizations. Conclusions: The study findings can inform internet-based parenting program delivery to enhance engagement for Indigenous families. %M 39576680 %R 10.2196/64994 %U https://pediatrics.jmir.org/2024/1/e64994 %U https://doi.org/10.2196/64994 %U http://www.ncbi.nlm.nih.gov/pubmed/39576680 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e55639 %T Embedding Technology-Assisted Parenting Interventions in Real-World Settings to Empower Parents of Children With Adverse Childhood Experiences: Co-Design Study %A Aldridge,Grace %A Wu,Ling %A Seguin,Joshua Paolo %A Robinson,Jennifer %A Battaglia,Elizabeth %A Olivier,Patrick %A Yap,Marie B H %+ Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Level 5, 18 Innovation Walk, Clayton Campus, Clayton, 3800, Australia, 61 3 9905 0723, marie.yap@monash.edu %K co-design %K service design %K intervention %K digital technology %K parenting %K children %K technology %K parenting program %K health care services %K adverse childhood experience %K ACE %K mental disorder %K innovate %K social services %K community health %K evidence-based %K parenting intervention %D 2024 %7 22.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Adverse childhood experiences are strongly associated with mental disorders in young people. Parenting interventions are available through community health settings and can intervene with adverse childhood experiences that are within a parent’s capacity to modify. Technology can minimize common barriers associated with engaging in face-to-face parenting interventions. However, families experiencing adversity face unique barriers to engaging with technology-assisted parenting interventions. Formative research using co-design methodology to provide a deep contextual understanding of these barriers can help overcome unique barriers and ensure these families can capitalize on the benefits of technology-assisted parenting interventions. Objective: This study aims to innovate the parenting support delivered by a community health and social service with technology by adapting an existing, evidence-based, technology-assisted parenting intervention. Methods: Staff (n=3) participated in dialogues (n=2) and co-design workshops (n=8) exploring needs and preferences for a technology-assisted parenting intervention and iteratively developing a prototype intervention (Parenting Resilient Kids [PaRK]-Lite). Parents (n=3) received PaRK-Lite and participated in qualitative interviews to provide feedback on their experience and PaRK-Lite’s design. Results: PaRK-Lite’s hybrid design leverages simple and familiar modes of technology (podcasts) to deliver intervention content and embeds reflective practice into service provision (microcoaching) to enhance parents’ empowerment and reduce service dependency. A training session, manuals, session plans, and templates were also developed to support the delivery of microcoaching. Feedback data from parents overall indicated that PaRK-Lite met their needs, suggesting that service providers can play a key role in the early phases of service innovation for parents. Conclusions: The co-designed technology-assisted parenting intervention aims to offer both parents and clinicians a novel and engaging resource for intervening with maladaptive parenting, contributing to efforts to respond to childhood adversity and improve child mental health. Future research in the field of human-computer interaction and health service design can consider our findings in creating engaging interventions that have a positive impact on the well-being of children and families. %M 39576676 %R 10.2196/55639 %U https://formative.jmir.org/2024/1/e55639 %U https://doi.org/10.2196/55639 %U http://www.ncbi.nlm.nih.gov/pubmed/39576676 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e50710 %T Health Perceptions and Practices of a Telewellness Fitness Program: Exploratory Case Study %A Ahumada-Newhart,Veronica %A Wood,Taffeta %A Satake,Noriko %A Marcin,James P %K telehealth %K telewellness %K online fitness %K health equity %K community health %K group exercise %K mobile phone %K mobile device %D 2024 %7 21.11.2024 %9 %J JMIR Form Res %G English %X Background: During the COVID-19 pandemic, many people lacked access to group fitness opportunities due to elevated risk of infection, lockdown, and closure of exercise facilities. Additionally, many people experienced higher than average rates of mental health burden (eg, anxiety and stress). To help address these needs, an existing in-person community exercise class, taught by a faculty member from an academic medical center, transitioned to an online synchronous (OS) physical fitness class via the Zoom (Zoom Video Communications) videoconferencing platform. As such, the instructor advertised the OS fitness classes through an existing email list of community members and university faculty, staff, students, or alumni email listservs. This telewellness intervention sought to create a sense of community, build social support, and promote physical and mental wellness during the COVID-19 pandemic. Objective: Our aim was to determine the perceived mental and physical health benefits of attending an OS fitness class for community members, including health care workers. We also assessed the use and functionality of related technologies necessary for delivering and attending the fitness classes. Methods: An online survey questionnaire was created and tested to collect quantitative and qualitative data for an exploratory study. Data were collected to evaluate the fitness class, motivation, perceived health benefits, and related technologies. A convenience sample of people who had participated in the OS fitness classes was recruited for this study via an emailed recruitment flyer. Results: A total of 51 participants accessed and completed the survey questionnaire. Survey participants consisted of 28 of 51 (55%) with a university affiliation, 17 of 51 (33%) with no university affiliation, and 6 of 51 (12%) who declined to state. The largest group of participants reporting full-time employment (18/51, 35%) also reported university affiliation with the academic medical center. In this group, 13 of 51 (25%) participants reported full-time employment, university affiliation, and doctoral degrees. High overall exercise class satisfaction was observed in the survey responses (mean 4.0, SD 1). Data analyses revealed significant perceived value of both mental and physical health benefits as motivating factors for participating in the OS fitness class. Challenges were identified as not being able to receive individual feedback from the instructor and the inability of some participants to see if they were in sync with the rest of the class. Conclusions: Results provide preliminary support for the use of online videoconferencing fitness platforms to promote wellness and facilitate group exercise in the community during times of high infection risk. Future studies should continue to explore perceived benefits, mental and physical wellness, best practices, and the design of related technologies. %R 10.2196/50710 %U https://formative.jmir.org/2024/1/e50710 %U https://doi.org/10.2196/50710 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e44553 %T Digital Homework Support Program for Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: Protocol for a Randomized Controlled Trial %A Gollier-Briant,Fanny %A Ollivier,Laurence %A Joalland,Pierre-Hugues %A Mouchabac,Stéphane %A Leray,Philippe %A Bonnot,Olivier %+ Barthélémy Durand Hospital, 2 Route de Longpont, Sainte Geneviere des Bois, 91700, France, 33 637702571, olivier.bonnot@gmail.com %K attention-deficit/hyperactivity disorder %K mobile app %K assisted homework session %K digital mental health %K e-health %K smartphone %K psychiatry %K neurodeveloppemental disorders %D 2024 %7 21.11.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Attention-deficit/hyperactivity disorder (ADHD) affects 4% to 5% of the general population. Homework sessions are frequent conflictual moments characterized by increased anxiety in children and stress in their parents, contributing to a lower family quality of life. Children with ADHD experience more severe homework problems than typically developing peers. Poor academic performance in individuals with ADHD is partly attributed to challenging homework. Psychoeducational and school-based approaches are time-consuming and not fully accessible to professionals. Digital tools, such as smartphone and tablet apps, might offer an interesting alternative. We present our digital homework support program for children and adolescents, known as “Programme d’Aide Numérique aux Devoirs pour Enfant avec TDA-H” (PANDAH), along with the study protocol of our ongoing randomized controlled trial. Objective: This study aims to test PANDAH’s efficacy in improving homework performance and family quality of life. Methods: Individuals aged 9-16 years with an ADHD diagnosis and no comorbid psychiatric disorders are included. This is a multicenter study involving 9 reference centers for ADHD in France. The study comprises (1) a 3-month period with a randomized controlled trial design, where participants are divided into 2 parallel groups (group 1: care as usual or waiting list; group 2: PANDAH app), followed by (2) an extension period of 3 months (months 3-6), during which all participants will have access to the app. This second phase serves as a crucial incentive for patients initially randomly assigned to group 1. Assessments will be conducted at baseline, month 3, and month 6 for each patient by trained psychologists. The primary end point will be the global Homework Performance Questionnaire (HPQ), Parent version score at 6 months. The main analysis will adhere to the “intent-to-treat principle” (all patient data will be analyzed according to their initial group determined by randomization). We expect (1) HPQ score improvement in individuals using the app during the first 3-month period compared to individuals not using the app; (2) greater HPQ score improvement for individuals using the app for 6 months compared to those using the app for 3 months only; and (3) adherence to the PANDAH program, measured with in-app metrics. Results: Recruitment began in January 2024, and the trial is ongoing. Conclusions: This study contributes to the digital transformation of health care. The use of smartphone apps in self-care and self-management is a societal phenomenon, and its implementation in the field of psychiatry is of particular interest. The app might serve as both valuable support for patients and an opportunity for parents to distance themselves from conflict-laden homework sessions. Since the market for smartphone apps in the health care and well-being sector is primarily industry driven, it is crucial to have an academic conception and evaluation of such digital tools. Trial Registration: ClinicalTrials.gov NCT04857788; https://clinicaltrials.gov/ct2/show/NCT04857788 International Registered Report Identifier (IRRID): PRR1-10.2196/44553 %M 39571155 %R 10.2196/44553 %U https://www.researchprotocols.org/2024/1/e44553 %U https://doi.org/10.2196/44553 %U http://www.ncbi.nlm.nih.gov/pubmed/39571155 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e52883 %T Web-Based Intervention Using Self-Compassionate Writing to Induce Positive Mood in Family Caregivers of Older Adults: Quantitative Study %A Wiita,Farah %A Ho,Aileen K %A Weinstein,Netta %+ School of Psychology and Clinical Language Sciences, University of Reading, Earley Gate, Berkshire, RG6 6AL, United Kingdom, 44 7951506136, f.l.wiita@pgr.reading.ac.uk %K self-compassion %K caregivers %K mindfulness %K intervention %K writing %K experimental %D 2024 %7 21.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Caregiver burden can impact the mental health of family caregivers, but self-compassion may help reduce this impact. Brief self-compassion interventions have been shown to be useful but have not been tested in family caregivers of older adults. Objective: This study aimed to test the effects of a brief self-compassion intervention and its components (self-kindness, common humanity, and mindfulness) on mental well-being and mood when reflecting on difficult family caregiving experiences. Methods: British caregivers were recruited through a web-based panel. Three experimental studies manipulated the self-compassion intervention. In study 1 (n=206) and study 2 (n=224), participants wrote about a difficult caregiving experience while focusing on 1 self-compassion component (self-kindness, common humanity, or mindfulness). In study 3 (n=222) participants focused on all components. Self-compassion, serenity, guilt, and sadness were measured. Results: In studies 1 and 2, condition effects showed mindfulness unexpectedly lowered mood. Inconsistent and modest benefits to affect were achieved by engagement in self-kindness and common humanity in study 1 (guilt [lowered]: P=.02 and sadness [lowered]: P=.04; serenity [nonsignificantly raised]: P=.20) and also in study 2 (sadness [nonsignificantly lowered]: P=.23 and guilt [nonsignificantly lowered]: P=.26; serenity [raised]: P=.33); significant benefits for self-compassion and mood were found in study 3 (serenity [raised]: P=.01, kindness [raised]: P=.003, and common humanity [raised]: P≤.001; guilt [lowered]: P<.001 and sadness [lowered]: P≤.001). More intensive efforts should be made to promote self-compassion in caregivers of older adults, with caution advised when relying primarily on mindfulness approaches. Conclusions: Self-compassionate writing may be beneficial for family caregivers, but more intensive interventions are needed. Further research is needed to determine the optimal dosage and content for achieving the greatest effects. %M 39571153 %R 10.2196/52883 %U https://formative.jmir.org/2024/1/e52883 %U https://doi.org/10.2196/52883 %U http://www.ncbi.nlm.nih.gov/pubmed/39571153 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e65010 %T Smartphone App for Improving Self-Awareness of Adherence to Edoxaban Treatment in Patients With Atrial Fibrillation (ADHERE-App Trial): Randomized Controlled Trial %A Yoon,Minjae %A Lee,Ji Hyun %A Kim,In-Cheol %A Lee,Ju-Hee %A Kim,Mi-Na %A Kim,Hack-Lyoung %A Lee,Sunki %A Kim,In Jai %A Choi,Seonghoon %A Park,Sung-Ji %A Hur,Taeho %A Hussain,Musarrat %A Lee,Sungyoung %A Choi,Dong-Ju %+ Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, 82, Gumi-ro 173 Beon-gil,, Bundang-gu, Seongnam, 13620, Republic of Korea, 82 31 787 7007, djchoi.snu@gmail.com %K mobile apps %K digital health %K atrial fibrillation %K anticoagulants %K medication adherence %K mobile phone %D 2024 %7 21.11.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Adherence to oral anticoagulant therapy is essential to prevent ischemic stroke in patients with atrial fibrillation (AF). Objective: This study aimed to evaluate whether smartphone app–based interventions improve medication adherence in patients with AF. Methods: This open-label, multicenter randomized controlled trial (ADHERE-App [Self-Awareness of Drug Adherence to Edoxaban Using an Automatic App Feedback System] study) enrolled patients with AF treated with edoxaban for stroke prevention. They were randomly assigned to app-conditioned feedback (intervention; n=248) and conventional treatment (control; n=250) groups. The intervention group received daily alerts via a smartphone app to take edoxaban and measure blood pressure and heart rate at specific times. The control group received only standard, guideline-recommended care. The primary end point was edoxaban adherence, measured by pill count at 3 or 6 months. Medication adherence and the proportion of adequate medication adherence, which was defined as ≥95% of continuous medication adherence, were evaluated. Results: Medication adherence at 3 or 6 months was not significantly different between the intervention and control groups (median 98%, IQR 95%-100% vs median 98%, IQR 91%-100% at 3 months, P=.06; median 98%, IQR 94.5%-100% vs median 97.5%, IQR 92.8%-100% at 6 months, P=.15). However, the proportion of adequate medication adherence (≥95%) was significantly higher in the intervention group at both time points (76.8% vs 64.7% at 3 months, P=.01; 73.9% vs 61% at 6 months, P=.007). Among patients aged >65 years, the intervention group showed a higher medication adherence value and a higher proportion of adequate medication adherence (≥95%) at 6 months. Conclusions: There was no difference in edoxaban adherence between the groups. However, the proportion of adequate medication adherence was higher in the intervention group, and the benefit of the smartphone app–based intervention on medication adherence was more pronounced among older patients than among younger patients. Given the low adherence to oral anticoagulants, especially among older adults, using a smartphone app may potentially improve medication adherence. Trial Registration: International Clinical Trials Registry Platform KCT0004754; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=28496&search_page=L International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2021-048777 %M 39570659 %R 10.2196/65010 %U https://www.jmir.org/2024/1/e65010 %U https://doi.org/10.2196/65010 %U http://www.ncbi.nlm.nih.gov/pubmed/39570659 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e57109 %T Engagement and Acceptability of Acceptance and Commitment Therapy in Daily Life in Early Psychosis: Secondary Findings From a Multicenter Randomized Controlled Trial %A van Aubel,Evelyne %A Vaessen,Thomas %A Uyttebroek,Lotte %A Steinhart,Henrietta %A Beijer-Klippel,Annelie %A Batink,Tim %A van Winkel,Ruud %A de Haan,Lieuwe %A van der Gaag,Mark %A van Amelsvoort,Thérèse %A Marcelis,Machteld %A Schirmbeck,Frederike %A Reininghaus,Ulrich %A Myin-Germeys,Inez %+ Center for Contextual Psychiatry, Psychiatry Research Group, Department of Neurosciences, KU Leuven, Herestraat 49, ON5B bus 1029, Leuven, 3000, Belgium, 32 16 37 31 74, lotte.uyttebroek@kuleuven.be %K acceptance and commitment therapy %K ACT %K first episode of psychosis %K FEP %K ultrahigh risk for psychosis %K UHR %K ecological momentary intervention %K EMI %K mobile health %K mHealth %K blended care %K mobile phone %D 2024 %7 21.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Acceptance and commitment therapy (ACT) is promising in the treatment of early psychosis. Augmenting face-to-face ACT with mobile health ecological momentary interventions may increase its treatment effects and empower clients to take treatment into their own hands. Objective: This study aimed to investigate and predict treatment engagement with and acceptability of acceptance and commitment therapy in daily life (ACT-DL), a novel ecological momentary intervention for people with an ultrahigh risk state and a first episode of psychosis. Methods: In the multicenter randomized controlled trial, 148 individuals with ultrahigh risk or first-episode psychosis aged 15-65 years were randomized to treatment as usual only (control) or to ACT-DL combined with treatment as usual (experimental), consisting of 8 face-to-face sessions augmented with an ACT-based smartphone app, delivering ACT skills and techniques in daily life. For individuals in the intervention arm, we collected data on treatment engagement with and acceptability of ACT-DL during and after the intervention. Predictors of treatment engagement and acceptability included baseline demographic, clinical, and functional outcomes. Results: Participants who received ACT-DL in addition to treatment as usual (n=71) completed a mean of 6 (SD 3) sessions, with 59% (n=42) of participants completing all sessions. App engagement data (n=58) shows that, on a weekly basis, participants used the app 13 times and were compliant with 6 of 24 (25%) notifications. Distribution plots of debriefing scores (n=46) show that 85%-96% of participants reported usefulness on all acceptability items to at least some extent (scores ≥2; 1=no usefulness) and that 91% (n=42) of participants reported perceived burden by number and length of notifications (scores ≥2; 1=no burden). Multiple linear regression models were fitted to predict treatment engagement and acceptability. Ethnic minority backgrounds predicted lower notification response compliance (B=–4.37; P=.01), yet higher app usefulness (B=1.25; P=.049). Negative (B=–0.26; P=.01) and affective (B=0.14; P=.04) symptom severity predicted lower and higher ACT training usefulness, respectively. Being female (B=–1.03; P=.005) predicted lower usefulness of the ACT metaphor images on the app. Conclusions: Our results corroborate good treatment engagement with and acceptability of ACT-DL in early psychosis. We provide recommendations for future intervention optimization. Trial Registration: OMON NL46439.068.13; https://onderzoekmetmensen.nl/en/trial/24803 %M 39570655 %R 10.2196/57109 %U https://formative.jmir.org/2024/1/e57109 %U https://doi.org/10.2196/57109 %U http://www.ncbi.nlm.nih.gov/pubmed/39570655 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e51714 %T Effectiveness of Digital Health Interventions in Promoting Physical Activity Among College Students: Systematic Review and Meta-Analysis %A Bi,Siyuan %A Yuan,Junfeng %A Wang,Yanling %A Zhang,Wenxin %A Zhang,Luqin %A Zhang,Yongjuan %A Zhu,Rui %A Luo,Lin %+ School of Physical Education, Guizhou Normal University, Huaxi District, University Town, Siya Road, Guiyang, 550025, China, 86 86751983, 460022831@gznu.edu.cn %K digital health intervention %K college students %K physical activity behavior %K steps %K light intensity physical activity %K moderate to vigorous physical activity %K sedentary behavior %K knowledge synthesis %K systematic review %K meta-analysis %K physical activity %K eHealth %K digital health %K mobile phone %D 2024 %7 20.11.2024 %9 Review %J J Med Internet Res %G English %X Background: Recent studies offer conflicting conclusions about the effectiveness of digital health interventions in changing physical activity behaviors. In addition, research focusing on digital health interventions for college students remains relatively scarce. Objective: This study aims to examine the impact of digital health interventions on physical activity behaviors among college students, using objective measures as outcome indicators. Methods: In accordance with the 2020 PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, a comprehensive literature search was conducted across several databases, including MEDLINE (PubMed), Web of Science, Cochrane Library, and EBSCO (CINAHL Plus with full text), to identify relevant intervention studies published up to June 6, 2023. The inclusion criteria specified studies that examined the quantitative relationships between digital health interventions and physical activity among adults aged 18 years to 29 years, focusing on light physical activity (LPA), moderate to vigorous physical activity (MVPA), sedentary time (ST), or steps. Non–randomized controlled trials were excluded. The quality of the studies was assessed using the Cochrane Risk of Bias tool. Results were synthesized both narratively and quantitatively, where applicable. When sufficient homogeneity was found among studies, a random-effects model was used for meta-analysis to account for variability. Results: In total, 8 studies, encompassing 569 participants, were included in the analysis. The primary outcomes measured were LPA, MVPA, ST, and steps. Among these studies, 3 reported on LPA, 5 on MVPA, 5 on ST, and 3 on steps. The meta-analysis revealed a significant increase in steps for the intervention group compared with the control group (standardized mean difference [SMD] 0.64, 95% CI 0.37-0.92; P<.001). However, no significant differences were observed between the intervention and control groups regarding LPA (SMD –0.08, 95% CI –0.32 to 0.16; P=.51), MVPA (SMD 0.02, 95% CI –0.19 to 0.22; P=.88), and ST (SMD 0.03, 95% CI –0.18 to 0.24; P=.78). Conclusions: Digital health interventions are effective in increasing steps among college students; however, their effects on LPA, MVPA, and sedentary behavior are limited. Trial Registration: PROSPERO CRD42024533180; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=533180 %M 39566049 %R 10.2196/51714 %U https://www.jmir.org/2024/1/e51714 %U https://doi.org/10.2196/51714 %U http://www.ncbi.nlm.nih.gov/pubmed/39566049 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53236 %T Investigating the Effectiveness of Technology-Based Distal Interventions for Postpartum Depression and Anxiety: Systematic Review and Meta-Analysis %A Brocklehurst,Sarah P %A Morse,Alyssa R %A Cruwys,Tegan %A Batterham,Philip J %A Leach,Liana %A Robertson,Alysia M %A Sahib,Aseel %A Burke,Colette T %A Nguyen,Jessica %A Calear,Alison L %+ Centre for Mental Health Research, The Australian National University, 63 Eggleston Road, Acton, Canberra, 2601, Australia, 61 2 6125 8406, alison.calear@anu.edu.au %K postpartum %K depression %K anxiety %K birth %K adoptive %K parents %K mobile phone %D 2024 %7 19.11.2024 %9 Review %J J Med Internet Res %G English %X Background: Postpartum anxiety and depression are common in new parents. While effective interventions exist, they are often delivered in person, which can be a barrier for some parents seeking help. One approach to overcoming these barriers is the delivery of evidence-based self-help interventions via websites, smartphone apps, and other digital media. Objective: This study aims to evaluate the effectiveness of technology-based distal interventions in reducing or preventing symptoms of postpartum depression or anxiety in male and female birth and adoptive parents, explore the effectiveness of technology-based distal interventions in increasing social ties, and determine the level of adherence to and satisfaction with technology-based distal interventions. Methods: A systematic review and series of meta-analyses were conducted. Three electronic bibliographic databases (PsycINFO, PubMed, and Cochrane Library) were searched for randomized controlled trials evaluating technology-based distal interventions for postpartum depression or anxiety in birth and adoptive parents. Searches were updated on August 1, 2023, before conducting the final meta-analyses. Data on trial characteristics, effectiveness, adherence, satisfaction, and quality were extracted. Screening and data extraction were conducted by 2 reviewers. Risk of bias was assessed using the Joanna Briggs Institute quality rating scale for randomized controlled trials. Studies were initially synthesized qualitatively. Where possible, studies were also quantitatively synthesized through 5 meta-analyses. Results: Overall, 18 articles met the inclusion criteria for the systematic review, with 14 (78%) providing sufficient data for a meta-analysis. A small significant between-group effect on depression favored the intervention conditions at the postintervention (Cohen d=–0.28, 95% CI –0.41 to –0.15; P<.001) and follow-up (Cohen d=–0.27, 95% CI –0.52 to –0.02; P=.03) time points. A small significant effect on anxiety also favored the intervention conditions at the postintervention time point (Cohen d=–0.29, 95% CI –0.48 to –0.10; P=.002), with a medium effect at follow-up (Cohen d=–0.47, 95% CI –0.88 to –0.05; P=.03). The effect on social ties was not significant at the postintervention time point (Cohen d=0.04, 95% CI –0.12 to 0.21; P=.61). Effective interventions tended to be web-based cognitive behavioral therapy programs with reminders. Adherence varied considerably between studies, whereas satisfaction tended to be high for most studies. Conclusions: Technology-based distal interventions are effective in reducing symptoms of postpartum depression and anxiety in birth mothers. Key limitations of the reviewed evidence include heterogeneity in outcome measures, studies being underpowered to detect modest effects, and the exclusion of key populations from the evidence base. More research needs to be conducted with birth fathers and adoptive parents to better ascertain the effectiveness of interventions in these populations, as well as to further assess the effect of technology-based distal interventions on social ties. Trial Registration: PROSPERO CRD42021290525; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=290525 %M 39561361 %R 10.2196/53236 %U https://www.jmir.org/2024/1/e53236 %U https://doi.org/10.2196/53236 %U http://www.ncbi.nlm.nih.gov/pubmed/39561361 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e62725 %T Assessing Digital Phenotyping for App Recommendations and Sustained Engagement: Cohort Study %A Dwyer,Bridget %A Flathers,Matthew %A Burns,James %A Mikkelson,Jane %A Perlmutter,Elana %A Chen,Kelly %A Ram,Nanik %A Torous,John %+ Division of Digital Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02115, United States, 1 6176676700, jtorous@bidmc.harvard.edu %K engagement %K mental health %K digital phenotype %K pilot study %K phenotyping %K smartphone sensors %K anxiety %K sleep %K fitness %K depression %K qualitative %K app recommendation %K app use %K mobile phone %D 2024 %7 19.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Low engagement with mental health apps continues to limit their impact. New approaches to help match patients to the right app may increase engagement by ensuring the app they are using is best suited to their mental health needs. Objective: This study aims to pilot how digital phenotyping, using data from smartphone sensors to infer symptom, behavioral, and functional outcomes, could be used to match people to mental health apps and potentially increase engagement Methods: After 1 week of collecting digital phenotyping data with the mindLAMP app (Beth Israel Deaconess Medical Center), participants were randomly assigned to the digital phenotyping arm, receiving feedback and recommendations based on those data to select 1 of 4 predetermined mental health apps (related to mood, anxiety, sleep, and fitness), or the control arm, selecting the same apps but without any feedback or recommendations. All participants used their selected app for 4 weeks with numerous metrics of engagement recorded, including objective screentime measures, self-reported engagement measures, and Digital Working Alliance Inventory scores. Results: A total of 82 participants enrolled in the study; 17 (21%) dropped out of the digital phenotyping arm and 18 (22%) dropped out from the control arm. Across both groups, few participants chose or were recommended the insomnia or fitness app. The majority (39/47, 83%) used a depression or anxiety app. Engagement as measured by objective screen time and Digital Working Alliance Inventory scores were higher in the digital phenotyping arm. There was no correlation between self-reported and objective metrics of app use. Qualitative results highlighted the importance of habit formation in sustained app use. Conclusions: The results suggest that digital phenotyping app recommendation is feasible and may increase engagement. This approach is generalizable to other apps beyond the 4 apps selected for use in this pilot, and practical for real-world use given that the study was conducted without any compensation or external incentives that may have biased results. Advances in digital phenotyping will likely make this method of app recommendation more personalized and thus of even greater interest. %M 39560976 %R 10.2196/62725 %U https://formative.jmir.org/2024/1/e62725 %U https://doi.org/10.2196/62725 %U http://www.ncbi.nlm.nih.gov/pubmed/39560976 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e57814 %T Telemedicine Integrated Care Versus In-Person Care Mode for Patients With Short Stature: Comprehensive Comparison of a Retrospective Cohort Study %A Wang,Yipei %A Zhang,Pei %A Xing,Yan %A Shi,Huifeng %A Cui,Yunpu %A Wei,Yuan %A Zhang,Ke %A Wu,Xinxia %A Ji,Hong %A Xu,Xuedong %A Dong,Yanhui %A Jin,Changxiao %+ Institute of Hospital Management, Peking University Third Hospital, North Huayuan Road 49, Beijing, 100191, China, 86 010 82266543, jinchangxiao2023@163.com %K telemedicine %K telemedicine integrated care mode %K short stature %K clinical outcomes %K health-seeking behaviors %K cost analysis %K in-person care %K mobile health %K mHealth %K telehealth %K eHealth %K video virtual visit %K access to care %K children %K pediatrics %K China %K accessibility %K temporal %K spatial constraints %K chronic disease %D 2024 %7 19.11.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Telemedicine has demonstrated efficacy as a supplement to traditional in-person care when treating certain diseases. Nevertheless, more investigation is needed to comprehensively assess its potential as an alternative to in-person care and its influence on access to care. The successful treatment of short stature relies on timely and regular intervention, particularly in rural and economically disadvantaged regions where the disease is more prevalent. Objective: This study evaluated the clinical outcomes, health-seeking behaviors, and cost of telemedicine integrated into care for children with short stature in China. Methods: Our study involved 1241 individuals diagnosed with short stature at the pediatric outpatient clinic of Peking University Third Hospital between 2012 and 2023. Patients were divided into in-person care (IPC; 1183 patients receiving only in-person care) and telemedicine integrated care (TIC; 58 patients receiving both in-person and virtual care) groups. For both groups, the initial 71.43% (average of 58 percentages, with each percentage representing the ratio of patients in the treatment group) of visits were categorized into the pretelemedicine phase. We used propensity score matching to select individuals with similar baseline conditions. We used 7 variables such as age, gender, and medical insurance for the 1:5 closest neighbor match. Eventually, 115 patients in the IPC group and 54 patients in the TIC group were selected. The primary clinical outcome was the change in the standard height percentage. Health-seeking behavior was described by visit intervals in the pre- and post-telemedicine phases. The cost analysis compared costs both between different groups and between different visit modalities of the TIC group in the post-telemedicine phase. Results: In terms of clinical effectiveness, we demonstrated that the increase in height among the TIC group (ΔzTIC=0.74) was more substantial than that for the IPC group (ΔzIPC=0.51, P=.01; paired t test), while no unfavorable changes in other endpoints such as BMI or insulin-like growth factor 1 (IGF-1) levels were observed. As for health-seeking behaviors, the results showed that, during the post-telemedicine phase, the IPC group had a visit interval of 71.08 (IQR 50.75-90.73) days, significantly longer than the prior period (51.25 [IQR 34.75-82.00] days, P<.001; U test), whereas the TIC group’s visit interval remained unchanged. As for the cost per visit, there was no difference in the average cost per visit between the 2 groups nor between the pre- and post-telemedicine phases. During the post-telemedicine phase, within the TIC group, in-person visits had a higher average total cost, elevated medical and labor expenses, and greater medical cost compared with virtual visits. Conclusions: We contend that the rise in medical visits facilitated by integrating telemedicine into care effectively restored the previously constrained number of medical visits to their usual levels, without increasing costs. Our research underscores that administering prompt treatment may enable physicians to seize a crucial treatment opportunity for children with short stature, thus attaining superior results. %M 39560983 %R 10.2196/57814 %U https://www.jmir.org/2024/1/e57814 %U https://doi.org/10.2196/57814 %U http://www.ncbi.nlm.nih.gov/pubmed/39560983 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e59283 %T An Online Resource for Monitoring 24-Hour Activity in Children and Adolescents: Observational Analysis %A Loo,Benny Kai Guo %A Toh,Siao Hui %A Fadzully,Fadzlynn %A Zainuddin,Mohammad Ashik %A Abu Bakar,Muhammad Alif %A Gao,Joanne Shumin %A Teo,Jing Chun %A Lim,Ethel Jie Kai %A Tan,Beron Wei Zhong %A Chia,Michael Yong Hwa %A Chua,Terence Buan Kiong %A Tan,Kok Hian %K online %K physical activity %K sedentary behaviour %K sleep %K diet %K 24-hour activity %K child %K adolescent %D 2024 %7 18.11.2024 %9 %J JMIR Pediatr Parent %G English %X Background: The Singapore integrated 24-hour activity guide for children and adolescents was introduced to promote healthy lifestyle behaviors, including physical activity, sedentary behavior, sleep, and diet, to enhance metabolic health and prevent noncommunicable diseases. To support the dissemination and implementation of these recommendations, a user-friendly online resource was created to help children and adolescents adopt these behaviors in Singapore. Objective: This study aimed to assess the acceptability of the online resource in the adoption of healthier lifestyle behaviors, and the change in the users’ behaviors with the use of this online resource. Methods: Participants aged 7-17 years were required to log their activity levels of the past 7 days at the beginning and at the end of a 3-month period using the browser-based online resource, including information on the duration and frequency of moderate- to vigorous-intensity physical activity (MVPA), length of sedentary behavior, duration and regularity of sleep, and food portions. User satisfaction, on the length, ease of use, and relevance of the online resource, was also recorded using a 10-point Likert scale. Descriptive statistics and statistical analyses, including the Wilcoxon signed rank test and McNemar test, were carried out at baseline and at the end of 3 months. Results: A total of 46 participants were included for analysis. For physical activity, the number of days of MVPA increased from a median of 3 (IQR 2‐5) days to 4 (IQR 2‐5) days (P=.01). For sedentary behavior, the median daily average screen time decreased from 106 (IQR 60‐142.5) minutes to 90 (IQR 60‐185) minutes. For sleep, 10% (5/46) more participants met the recommended duration, and the number of days with regular sleep increased from a median of 6 (IQR 5‐7) days to 7 (IQR 5‐7) days (P=.03). For diet, there was a decrease in the portion of carbohydrates consumed from a median of 42% (IQR 30‐50) to 40% (IQR 30‐48.5; P=.03), and the number of days of water and unsweetened beverage consumption remained stable at a median of 5 days but with a higher IQR of 4‐7 days (P=.04). About 90% (39-41/46) of the participants reported that the online resource was relevant and easy to use, and the rating for user satisfaction remained favorable at a median of 8 with a higher IQR of 7‐9 (P=.005). Conclusions: The findings support the development of a dedicated online resource to assist the implementation of healthy lifestyle behaviors based on the Singapore integrated 24-hour activity guide for children and adolescents. This resource received favorable ratings and its use showed the adoption of healthier behaviors, including increased physical activity and sleep, as well as decreased sedentary time and carbohydrate consumption, at the end of a 3-month period. %R 10.2196/59283 %U https://pediatrics.jmir.org/2024/1/e59283 %U https://doi.org/10.2196/59283 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e67749 %T Author's Reply: Expanding the Scope: Reflections on Digital Smoking Cessation Strategies for Diverse Age Groups %A Fahey,Margaret C %+ Department of Psychology, Middle Tennessee State University, Academic Classroom Building, Murfreesboro, TN, 37130, United States, 1 615 898 5949, mfahey@mtsu.edu %K digital smoking cessation %K age group comparisons %K behavioral health intervention %K older adult %K cigarette %K tobacco %K quitting %K telehealth %K behavioral health %K public health %D 2024 %7 18.11.2024 %9 Letter to the Editor %J J Med Internet Res %G English %X %R 10.2196/67749 %U https://www.jmir.org/2024/1/e67749 %U https://doi.org/10.2196/67749 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e65929 %T Expanding the Scope: Reflections on Digital Smoking Cessation Strategies for Diverse Age Groups %A Wei,Bin %A Hu,Xin %A Wu,XiaoRong %+ The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, No. 17, Yongwai Zhengjie, Donghu District, Nanchang, Jiangxi, 330000, China, 86 13617093259, wxr98021@126.com %K digital smoking cessation %K age group comparisons %K behavioral health interventions %K older adults %K digital cessation treatment %K cigarettes %K tobacco %K quit %K telehealth %K behavioral health %K public health %D 2024 %7 18.11.2024 %9 Letter to the Editor %J J Med Internet Res %G English %X %M 39556825 %R 10.2196/65929 %U https://www.jmir.org/2024/1/e65929 %U https://doi.org/10.2196/65929 %U http://www.ncbi.nlm.nih.gov/pubmed/39556825 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e52435 %T Effectiveness of the Support From Community Health Workers and Health Care Professionals on the Sustained Use of Wearable Monitoring Devices Among Community-Dwelling Older Adults: Feasibility Randomized Controlled Trial %A Wong,Arkers Kwan Ching %A Bayuo,Jonathan %A Su,Jing Jing %A Wong,Frances Kam Yuet %A Chow,Karen Kit Sum %A Wong,Bonnie Po %A Wong,Siu Man %A Hui,Vivian %+ School of Nursing, Hong Kong Polytechnic University, GH 502, Hung Hom, Hong Kong, China (Hong Kong), 852 34003805, arkers.wong@polyu.edu.hk %K wearable monitoring device %K lay worker %K smartwatch %K older adult %K nurse %K engagement %K attrition %K engagement %K wearable %K user experience %D 2024 %7 18.11.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: The wearable monitoring device (WMD) is emerging as a promising tool for community-dwelling older adults to monitor personal health, enhance awareness of their activities, and promote healthy behaviors. However, the sustained use of WMDs among this population remains a significant challenge. Objective: This study aims to implement an interventional program that promotes and motivates the continued use of WMDs among older adults through a peer and professional support approach. This program will facilitate the integration of WMDs into their daily lives. Methods: This feasibility trial examined the following: (1) the usability of the WMD from the users’ perspectives; (2) the feasibility of the Live With Wearable Monitoring Device program; and (3) the effectiveness of the Live With Wearable Monitoring Device program among community-dwelling older adults. The intervention, based on Self-Determination Theory, involved using the Live With Wearable Monitoring Device program over a 3-month period, with ongoing professional and peer support provided by community health workers, aided by a nurse and social workers. This support included 1 home visit and biweekly communication via WhatsApp. Data were collected at baseline and at 1, 3, and 6 months. Results: A total of 39 participants were enrolled in the intervention group, while 37 participants were in the control group. The recruitment rate was high (76/89, 85%), and the attrition rate was low (8/76, 11%), indicating that the program is feasible for older adults. Participants in the intervention group exhibited higher self-efficacy, lower anxiety levels, and used the smartwatch more frequently, in terms of both days and hours, compared with the control group. A between-group difference was observed in self-efficacy between the intervention and control groups (β=3.31, 95% CI 0.36-6.25, P=.03), with statistically significant higher mean values recorded at all 4 time points. Conclusions: It is clear that merely providing a WMD to older adults does not guarantee its usage, particularly for those unfamiliar with how to utilize its health-related functions in their daily routines. This study implemented a theory-based program aimed at enhancing the ongoing use of WMDs among older adults, suggesting that continuous professional and peer support may significantly influence WMD usage. Trial Registration: ClinicalTrials.gov NCT05269303; https://clinicaltrials.gov/ct2/show/NCT05269303 %M 39556810 %R 10.2196/52435 %U https://www.jmir.org/2024/1/e52435 %U https://doi.org/10.2196/52435 %U http://www.ncbi.nlm.nih.gov/pubmed/39556810 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e55562 %T Reducing the Number of Intrusive Memories of Work-Related Traumatic Events in Frontline Health Care Staff During the COVID-19 Pandemic: Case Series %A Kubickova,Veronika %A Steel,Craig %A Moulds,Michelle L %A Kanstrup,Marie %A Beer,Sally %A Darwent,Melanie %A Keating,Liza %A Holmes,Emily A %A Iyadurai,Lalitha %+ Oxford Institute of Clinical Psychology Training and Research, Oxford Health NHS Foundation Trust, Isis Education Centre, Warneford Hospital, Oxford, OX3 7JX, United Kingdom, 44 1865226366, craig.steel@hmc.ox.ac.uk %K intrusive memories %K digital intervention %K psychological trauma %K remote delivery %K health care staff %K COVID-19 %K case series %D 2024 %7 18.11.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Frontline health care staff are frequently exposed to traumatic events as part of their work. Although this study commenced before the emergence of COVID-19, levels of exposure were heightened by the pandemic. Many health care staff members report intrusive memories of such events, which can elicit distress, affect functioning, and be associated with posttraumatic stress disorder symptoms in the long term. We need evidence-based interventions that are brief, preventative, nonstigmatizing, suitable for the working lives of frontline health care staff, and effective for repeated trauma exposure. A brief, guided imagery-competing task intervention involving a trauma reminder cue and Tetris gameplay may hold promise in this regard, given evidence that it can prevent and reduce the number of intrusive memories following trauma across various settings. Objective: This case series aims to investigate the impact of a brief imagery-competing task intervention on the number of intrusive memories, general functioning, and symptoms of posttraumatic stress, anxiety, and depression, and examine the feasibility and acceptability of the intervention for UK National Health Service frontline health care staff. The intervention was delivered with guidance from a clinical psychologist. Methods: We recruited 12 clinical staff from the UK National Health Service, specifically from emergency departments, the intensive care unit, and the ambulance service. We evaluated the intervention using an AB single-case experimental design, where the baseline (A) was the monitoring-only phase and the postintervention (B) period was the time after the intervention was first administered. Methods were adapted once the COVID-19 pandemic began. Results: There was a decrease (59%) in the mean number of intrusive memories per day from baseline (mean 1.29, SD 0.94) to postintervention (mean 0.54, SD 0.51). There was a statistically significant reduction in the number of intrusive memories from baseline to postintervention, as shown by an aggregated omnibus analysis with a small effect size (τ-U=–0.38; P<.001). Depression, anxiety, and posttraumatic stress symptoms all significantly reduced from preintervention to postintervention. Participants also reported improvements in functioning based on both quantitative and qualitative measures. The intervention was feasible to deliver and rated as acceptable by participants. Conclusions: These preliminary findings suggest that this brief therapist-guided imagery-competing task intervention offers a potential approach to mitigating the impact of work-related traumatic events in frontline health care staff, both during a pandemic and beyond. Randomized controlled trials will be an important next step. %M 39556801 %R 10.2196/55562 %U https://humanfactors.jmir.org/2024/1/e55562 %U https://doi.org/10.2196/55562 %U http://www.ncbi.nlm.nih.gov/pubmed/39556801 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e60865 %T Understanding Patients’ Preferences for a Digital Intervention to Prevent Posttreatment Deterioration for Bulimia-Spectrum Eating Disorders: User-Centered Design Study %A Liu,Jianyi %A Giannone,Alyssa %A Wang,Hailing %A Wetherall,Lucy %A Juarascio,Adrienne %+ Department of Psychological and Brain Sciences, Drexel University, 3201 Chestnut Street, Philadelphia, PA, 19104, United States, 1 2158951895, jl4528@drexel.edu %K bulimia nervosa %K binge eating %K digital intervention %K deterioration prevention %K eating disorder %K bulimia %K digital health %K deterioration %K maintenance %K mHealth %K mobile health app %K interviews %K qualitative %K user-centered design %K psychotherapy %K CBT %K cognitive behavioral therapy %K needs %K preferences %K mobile phone %D 2024 %7 18.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Deterioration rates after enhanced cognitive behavioral therapy (CBT-E) for patients with bulimia-spectrum eating disorders (BN-EDs) remain high, and decreased posttreatment skill use might be a particularly relevant contributor. Digital interventions could be an ideal option to improve skill use after treatment ends but they have yet to be investigated for BN-EDs. Objective: This study used a user-centered design approach to explore patients’ interest in a digital intervention to prevent deterioration after CBT-E and their desired features. Methods: A total of 12 participants who previously received CBT-E for BN-EDs and experienced at least a partial response to treatment completed a qualitative interview asking about their interests and needs for an app designed to prevent deterioration after treatment ended. Participants were also presented with features commonly used in digital interventions for EDs and were asked to provide feedback. Results: All 12 participants expressed interest in using an app to prevent deterioration after treatment ended. In total, 11 participants thought the proposed feature of setting a goal focusing on skill use weekly would help improve self-accountability for skill use, and 6 participants supported the idea of setting goals related to specific triggers because they would know what skills to use in high-risk situations. A total of 10 participants supported the self-monitoring ED behaviors feature because it could increase their awareness levels. Participants also reported wanting to track mood (n=6) and food intake (n=5) besides the proposed tracking feature. A total of 10 participants reported wanting knowledge-based content in the app, including instructions on skill practice (n=6), general mental health strategies outside of EDs (n=4), guided mindfulness exercises (n=3), and nutrition recommendations (n=3). Eight participants reported a desire for the app to send targeted push notifications, including reminders of skill use (n=7) and inspirational quotes for encouragement (n=3). Finally, 8 participants reported wanting a human connection in the app, 6 participants wishing to interact with other users to support and learn from each other, and 4 participants wanting to connect with professionals as needed. Overall, participants thought that having an app targeting skill use could provide continued support and improve self-accountability, thus lowering the risk of decreased skill use after treatment ended. Conclusions: Insights from participants highlighted the perceived importance of continued support for continued skill use after treatment ended. This study also provided valuable design implications regarding potential features focusing on facilitating posttreatment skill use to include in digital deterioration prevention programs. Future research should examine the optimal approaches to deliver the core features identified in this study that could lead to higher continued skill use and a lower risk of deterioration in the long term. %M 39556809 %R 10.2196/60865 %U https://formative.jmir.org/2024/1/e60865 %U https://doi.org/10.2196/60865 %U http://www.ncbi.nlm.nih.gov/pubmed/39556809 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e56636 %T Digital Exclusion and Cognitive Function in Elderly Populations in Developing Countries: Insights Derived From 2 Longitudinal Cohort Studies %A Duan,Sainan %A Chen,Dongxu %A Wang,Jinping %A Paramboor,Mohammed Sharooq %A Xia,Zhen %A Xu,Wanting %A Han,Kun %A Zhu,Tao %A Jiang,Xiaoqin %+ Department of Anesthesiology, West China Second University Hospital, Sichuan University, No 20, Section 3, South Renmin Road, Chengdu, 610041, China, 86 18180609218, 1598862657jxq@scu.edu.cn %K digital exclusion %K cognition %K cohort study %K developing country %K China Health and Retirement Longitudinal Study %K CHARLS %K %K MHAS %K cognitive decline %D 2024 %7 15.11.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Cognition disorders not only lead to adverse health consequences but also contribute to a range of socioeconomic challenges and diminished capacity for performing routine daily activities. In the digital era, understanding the impact of digital exclusion on cognitive function is crucial, especially in developing countries. Objective: This study aimed to evaluate the association between digital exclusion and cognitive function among elderly populations in developing countries. Methods: Using data from CHARLS (China Health and Retirement Longitudinal Study) from 2011 to 2020 and MHAS (Mexican Health & Aging Study) from 2012 to 2021, we defined digital exclusion as self-reported absence from the internet. Cognitive function was assessed through 5 tests: orientation, immediate verbal recall, delayed verbal recall, serial 7s, and figure recall. Cognitive function was assessed in 2 categories: worse cognition (a categorical variable that classifies cognition as either better or worse compared to the entire cohort population) and cognitive scores (a continuous variable representing raw cognitive scores across multiple follow-up waves). Logistic regression analyses and generalized estimating equation (GEE) analyses were used to examine the relationship between cognitive function and digital exclusion, adjusting for potential confounders, including demographics, lifestyle factors, history of chronic diseases, basic activities of daily living (BADL) disability, instrumental activities of daily living (IADL) disability, and basic cognitive abilities. Results: After excluding participants with probable cognitive impairment at baseline and those who did not have a complete cognitive assessment in any given year (ie, all tests in the cognitive assessment must be completed in any follow-up wave), a total of 24,065 participants in CHARLS (n=11,505, 47.81%) and MHAS (n=12,560, 52.19%) were included. Of these, 96.78% (n=11,135) participants in CHARLS and 70.02% (n=8795) in MHAS experienced digital exclusion. Adjusted logistic regression analyses revealed that individuals with digital exclusion were more likely to exhibit worse cognitive performance in both CHARLS (odds ratio [OR] 2.04, 95% CI 1.42-2.99; P<.001) and MHAS (OR 1.40, 95% CI 1.26-1.55; P<.001). Gender and age did not significantly modify the relationship between digital exclusion and worse cognition (intervention P>.05). The fully adjusted mean differences in global cognitive scores between the 2 groups were 0.98 (95% CI 0.70-1.28; P<.001) in CHARLS and 0.50 (95% CI 0.40-0.59; P<.001) in MHAS. Conclusions: A substantial proportion of older adults, particularly in China, remain excluded from internet access. Our study examined longitudinal changes in cognitive scores and performed cross-sectional comparisons using Z-score standardization. The findings suggest that digital exclusion is linked to an increased risk of cognitive decline among older adults in developing countries. Promoting internet access may help mitigate this risk and support better cognitive health in these populations. %M 39546790 %R 10.2196/56636 %U https://www.jmir.org/2024/1/e56636 %U https://doi.org/10.2196/56636 %U http://www.ncbi.nlm.nih.gov/pubmed/39546790 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e53768 %T Use of Random Forest to Predict Adherence in an Online Intervention for Depression Using Baseline and Early Usage Data: Model Development and Validation on Retrospective Routine Care Log Data %A Wenger,Franziska %A Allenhof,Caroline %A Schreynemackers,Simon %A Hegerl,Ulrich %A Reich,Hanna %+ Clinic for Psychiatry, Psychosomatics and Psychotherapy, University Hospital, Goethe University Frankfurt, Heinrich-Hoffmann-Str. 10, Frankfurt am Main, 60528, Germany, 49 3412238744, franziska.wenger@deutsche-depressionshilfe.de %K depression %K adherence %K machine learning %K digital interventions %K random forest %K iFightDepression %K iFD %K online intervention %D 2024 %7 15.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Online interventions, such as the iFightDepression (iFD) tool, are increasingly recognized as effective alternatives to traditional face-to-face psychotherapy or pharmacotherapy for treating depression. However, particularly when used outside of study settings, low adherence rates and the resulting diminished benefits of the intervention can limit their effectiveness. Understanding the factors that predict adherence would allow for early, tailored interventions for individuals at risk of nonadherence, thereby enhancing user engagement and optimizing therapeutic outcomes. Objective: This study aims to develop and evaluate a random forest model that predicts adherence to the iFD tool to identify users at risk of noncompletion. The model was based on characteristics collected during baseline and the first week of the intervention in patients with depression. Methods: Log data from 4187 adult patients who registered for the iFD tool between October 1, 2016, and May 5, 2022, and provided informed consent were statistically analyzed. The resulting data set was divided into training (2932/4187, 70%) and test (1255/4187, 30%) sets using a randomly stratified split. The training data set was utilized to train a random forest model aimed at predicting each user’s adherence at baseline, based on the hypothesized predictors: age, self-reported gender, expectations of the intervention, current or previous depression treatments, confirmed diagnosis of depression, baseline 9-item Patient Health Questionnaire (PHQ-9) score, accompanying guide profession, and usage behavior within the first week. After training, the random forest model was evaluated on the test data set to assess its predictive performance. The importance of each variable in predicting adherence was analyzed using mean decrease accuracy, mean decrease Gini, and Shapley Additive Explanations values. Results: Of the 4187 patients evaluated, 1019 (24.34%) were classified as adherent based on our predefined definition. An initial random forest model that relied solely on sociodemographic and clinical predictors collected at baseline did not yield a statistically significant adherence prediction. However, after incorporating each patient’s usage behavior during the first week, we achieved a significant prediction of adherence (P<.001). Within this prediction, the model achieved an accuracy of 0.82 (95% CI 0.79-0.84), an F1-score of 0.53, an area under the curve of 0.83, and a specificity of 0.94 for predicting nonadherent users. The key predictors of adherence included logs, word count on the first workshop’s worksheet, and time spent on the tool, all measured during the first week. Conclusions: Our results highlight that early engagement, particularly usage behavior during the first week of the online intervention, is a far greater predictor of adherence than any sociodemographic or clinical factors. Therefore, analyzing usage behavior within the first week and identifying nonadherers through the algorithm could be beneficial for tailoring interventions aimed at improving user adherence. This could include follow-up calls or face-to-face discussions, optimizing resource utilization in the process. %M 39546342 %R 10.2196/53768 %U https://formative.jmir.org/2024/1/e53768 %U https://doi.org/10.2196/53768 %U http://www.ncbi.nlm.nih.gov/pubmed/39546342 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e60575 %T A Video-Based Communication Intervention for Fecal Ostomy Surgery (CI-oSurg): Protocol for Open Pilot Testing to Improve Intervention Acceptability and Feasibility %A Cauley,Christy Elaine %A Rubio,Atziri %A Brindle,Mary %A Cooper,Zara %A Vranceanu,Ana-Maria %A Ritchie,Christine S %+ Department of Surgery, Massachusetts General Hospital, Harvard Medical School, 55 Fruit St., Boston, MA, 02114, United States, 1 6177268129, ccauley@mgh.harvard.edu %K fecal ostomy %K distress %K open pilot %K fecal ostomy surgeryl CI-oSurg %K intervention acceptability %K biopsychosocial outcomes %K psychosocial support %K ostomy care %D 2024 %7 15.11.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Approximately 100,000 patients undergo fecal ostomy operations annually across the United States. This patient population experiences high surgical complication rates and poor biopsychosocial outcomes. Surgical teams are not trained to address the psychosocial needs that often arise during recovery after fecal ostomy surgery. Objective: This study aims to refine and establish the acceptability and usability of the Communication Intervention for fecal ostomy Surgery (CI-oSurg), a web-based communication intervention aimed at reducing distress among patients recovering from ostomy surgery. Methods: We describe the proposed study design, methodology, and training protocol. We will conduct an open pilot (n=24 patients and n=8 clinicians) of video-based training to first identify the level and types of distress patients are experiencing. Next, patients will view web videos that address frequent challenges faced by ostomy patients, considering practical management and emotional and adaptation concerns. Qualitative one-to-one semistructured interviews will be conducted with participants to explore the acceptability and feasibility of the program and refine the intervention and study procedures. Results: This study has been approved by the Mass General Brigham Institutional Review Board. Study funding has been obtained, and recruitment is planned for the fall of 2024. Conclusions: Through this study, we will refine CI-oSurg, a web-based communication intervention focused on reducing distress after ostomy surgery, to improve intervention acceptability and usability. These improvements will allow us to establish the usability and acceptability of the intervention before efficacy testing to determine the ability of this intervention to reduce distress after fecal ostomy surgery. Trial Registration: ClinicalTrials.gov NCT06320002; https://clinicaltrials.gov/study/NCT06320002 International Registered Report Identifier (IRRID): PRR1-10.2196/60575 %M 39546348 %R 10.2196/60575 %U https://www.researchprotocols.org/2024/1/e60575 %U https://doi.org/10.2196/60575 %U http://www.ncbi.nlm.nih.gov/pubmed/39546348 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e57967 %T The Impact of Comment Slant and Comment Tone on Digital Health Communication Among Polarized Publics: A Web-Based Survey Experiment %A Lu,Fangcao %A Tu,Caixie %+ School of Journalism and Communication, Shanghai University, Shanghai University, 149 Yanchang Road, Shanghai, 200072, China, 852 56207827, cxtu@shu.edu.cn %K comments slant %K incivility %K social media %K influence of presumed influence %K health compliance %K mask wearing %K web survey %D 2024 %7 15.11.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Public attitudes toward health issues are becoming increasingly polarized, as seen in social media comments, which vary from supportive to oppositional and frequently include uncivil language. The combined effects of comment slant and comment tone on health behavior among a polarized public need further examination. Objective: This study aims to examine how social media users’ prior attitudes toward mask wearing and their exposure to a mask-wearing–promoting post, synchronized with polarized and hostile discussions, affect their compliance with mask wearing. Methods: The study was a web-based survey experiment with participants recruited from Amazon Mechanical Turk. A total of 522 participants provided consent and completed the study. Participants were assigned to read a fictitious mask-wearing–promoting social media post with either civil anti–mask-wearing comments (130/522, 24.9%), civil pro–mask-wearing comments (129/522, 24.7%), uncivil anti–mask-wearing comments (131/522, 25.1%), or uncivil pro–mask-wearing comments (132/522, 25.3%). Following this, the participants were asked to complete self-assessed questionnaires. The PROCESS macro in SPSS (model 12; IBM Corp) was used to test the 3-way interaction effects between comment slant, comment tone, and prior attitudes on participants’ presumed influence from the post and their behavioral intention to comply with mask-wearing. Results: Anti–mask-wearing comments led social media users to presume less influence about others’ acceptance of masks (B=1.49; P<.001; 95% CI 0.98-2.00) and resulted in decreased mask-wearing intention (B=0.07; P=.03; 95% CI 0.01-0.13). Comment tone with incivility also reduced compliance with mask-wearing (B=–0.44; P=.02; 95% CI –0.81 to –0.07). Furthermore, polarized attitudes had a direct impact (B=0.86; P<.001; 95% CI 0.45-1.26) and also interacted with both the slant and tone of comments, influencing mask-wearing intention. Conclusions: Pro–mask-wearing comments enhanced presumed influence and compliance of mask-wearing, but incivility in the comments hindered this positive impact. Antimaskers showed increased compliance when they were unable to find civil support for their opinion in the social media environment. The findings suggest the need to correct and moderate uncivil language and misleading information in online comment sections while encouraging the posting of supportive and civil comments. In addition, information literacy programs are needed to prevent the public from being misled by polarized comments. %M 39546341 %R 10.2196/57967 %U https://www.jmir.org/2024/1/e57967 %U https://doi.org/10.2196/57967 %U http://www.ncbi.nlm.nih.gov/pubmed/39546341 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e50963 %T Effectiveness of the Offer of the Smoke Free Smartphone App Compared With No Intervention for Smoking Cessation: Pragmatic Randomized Controlled Trial %A Jackson,Sarah %A Kale,Dimitra %A Beard,Emma %A Perski,Olga %A West,Robert %A Brown,Jamie %+ Department of Behavioural Science and Health, University College London, 1-19 Torrington Place, London, WC1E 6BT, United Kingdom, 44 2076795634, s.e.jackson@ucl.ac.uk %K randomized controlled trial %K smartphone app %K smoking cessation %K digital intervention %K tobacco %K mobile phone %D 2024 %7 15.11.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital technologies offer the potential for low-cost, scalable delivery of interventions to promote smoking cessation. Objective: We aimed to evaluate the effectiveness of the offer of Smoke Free—an evidence-informed, widely used app—for smoking cessation versus no support. Methods: In this 2-arm randomized controlled trial, 3143 motivated adult smokers were recruited online between August 2020 and April 2021 and randomized to receive an offer of the Smoke Free app plus follow-up (intervention arm) versus follow-up only (comparator arm). Both groups were shown a brief message at the end of the baseline questionnaire encouraging them to make a quit attempt. The primary outcome was self-reported 6-month continuous abstinence assessed 7 months after randomization. Secondary outcomes included quit attempts in the first month post randomization, 3-month continuous abstinence assessed at 4 months, and 6-month continuous abstinence at 7 months among those who made a quit attempt. The primary analysis was performed on an intention-to-treat (ITT) analysis basis. Sensitivity analyses included (1) restricting the intervention group to those who took up the offer of the app, (2) using complete cases, and (3) using multiple imputation. Results: The effective follow-up rate for 7 months was 41.9%. The primary analysis showed no evidence of a benefit of the intervention on rates of 6-month continuous abstinence (intervention 6.8% vs comparator 7.0%; relative risk 0.97, 95% CI 0.75-1.26). Analyses of all secondary outcomes also showed no evidence of a benefit. Similar results were observed on complete cases and using multiple imputation. When the intervention group was restricted to those who took up the offer of the app (n=395, 25.3%), participants in the intervention group were 80% more likely to report 6-month continuous abstinence (12.7% vs 7.0%; relative risk 1.80, 95% CI 1.30-2.45). Equivalent subgroup analyses produced similar results on the secondary outcomes. These differences persisted after adjustment for key baseline characteristics. Conclusions: Among motivated smokers provided with very brief advice to quit, the offer of the Smoke Free app did not have a detectable benefit for cessation compared with follow-up only. However, the app increased quit rates when smokers randomized to receive the app downloaded it. Trial Registration: ISRCTN ISRCTN85785540; https://www.isrctn.com/ISRCTN85785540 International Registered Report Identifier (IRRID): RR2-https://onlinelibrary.wiley.com/doi/full/10.1111/add.14652 %M 39546331 %R 10.2196/50963 %U https://www.jmir.org/2024/1/e50963 %U https://doi.org/10.2196/50963 %U http://www.ncbi.nlm.nih.gov/pubmed/39546331 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e47774 %T Machine Learning Methods to Personalize Persuasive Strategies in mHealth Interventions That Promote Physical Activity: Scoping Review and Categorization Overview %A Brons,Annette %A Wang,Shihan %A Visser,Bart %A Kröse,Ben %A Bakkes,Sander %A Veltkamp,Remco %+ Department of Information and Computing Sciences, Utrecht University, Princetonplein 5, Utrecht, 3584 CC, Netherlands, 31 621156976, R.C.Veltkamp@uu.nl %K artificial intelligence %K exercise %K mobile app %K adaptive %K tailoring %K supervised learning %K reinforcement learning %K recommender system %D 2024 %7 15.11.2024 %9 Review %J J Med Internet Res %G English %X Background: Although physical activity (PA) has positive effects on health and well-being, physical inactivity is a worldwide problem. Mobile health interventions have been shown to be effective in promoting PA. Personalizing persuasive strategies improves intervention success and can be conducted using machine learning (ML). For PA, several studies have addressed personalized persuasive strategies without ML, whereas others have included personalization using ML without focusing on persuasive strategies. An overview of studies discussing ML to personalize persuasive strategies in PA-promoting interventions and corresponding categorizations could be helpful for such interventions to be designed in the future but is still missing. Objective: First, we aimed to provide an overview of implemented ML techniques to personalize persuasive strategies in mobile health interventions promoting PA. Moreover, we aimed to present a categorization overview as a starting point for applying ML techniques in this field. Methods: A scoping review was conducted based on the framework by Arksey and O’Malley and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) criteria. Scopus, Web of Science, and PubMed were searched for studies that included ML to personalize persuasive strategies in interventions promoting PA. Papers were screened using the ASReview software. From the included papers, categorized by the research project they belonged to, we extracted data regarding general study information, target group, PA intervention, implemented technology, and study details. On the basis of the analysis of these data, a categorization overview was given. Results: In total, 40 papers belonging to 27 different projects were included. These papers could be categorized in 4 groups based on their dimension of personalization. Then, for each dimension, 1 or 2 persuasive strategy categories were found together with a type of ML. The overview resulted in a categorization consisting of 3 levels: dimension of personalization, persuasive strategy, and type of ML. When personalizing the timing of the messages, most projects implemented reinforcement learning to personalize the timing of reminders and supervised learning (SL) to personalize the timing of feedback, monitoring, and goal-setting messages. Regarding the content of the messages, most projects implemented SL to personalize PA suggestions and feedback or educational messages. For personalizing PA suggestions, SL can be implemented either alone or combined with a recommender system. Finally, reinforcement learning was mostly used to personalize the type of feedback messages. Conclusions: The overview of all implemented persuasive strategies and their corresponding ML methods is insightful for this interdisciplinary field. Moreover, it led to a categorization overview that provides insights into the design and development of personalized persuasive strategies to promote PA. In future papers, the categorization overview might be expanded with additional layers to specify ML methods or additional dimensions of personalization and persuasive strategies. %M 39546334 %R 10.2196/47774 %U https://www.jmir.org/2024/1/e47774 %U https://doi.org/10.2196/47774 %U http://www.ncbi.nlm.nih.gov/pubmed/39546334 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e57390 %T The Feasibility of AgileNudge+ Software to Facilitate Positive Behavioral Change: Mixed Methods Design %A Shojaei,Fereshtehossadat %A Shojaei,Fatemehalsadat %A Desai,Archita P %A Long,Emily %A Mehta,Jade %A Fowler,Nicole R %A Holden,Richard J %A Orman,Eric S %A Boustani,Malaz %+ Luddy School of Informatics, Computing, and Engineering, Indiana University Bloomington, 700 N Woodlawn Ave, Bloomington, IN, 47408, United States, 1 8128565754, fshojaei@iu.edu %K AgileNudge+ %K agile %K nudge strategy %K nudging interventions %K agile implementation %K human behavior %K software design %K human-computer interaction %K user experience design %K usability testing %D 2024 %7 13.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: In today’s digital age, web-based apps have become integral to daily life, driving transformative shifts in human behavior. “AgileNudge+” (Indiana University Center for Health Innovation and Implementation Science) is a web-based solution to simplify the process of positive behavior change using nudging as an intervention. By integrating knowledge from behavioral economics with technology, AgileNudge+ organizes multiple steps, simplifies complex tasks, minimizes errors by enhancing user engagement, and provides resources for creating and testing nudge interventions. Objective: This paper aimed to outline the design process, methodologies, and usefulness of “AgileNudge+” for the development of evidence-based nudges. It used a mixed methods approach to evaluate the software’s interface usability and usefulness for creating and testing nudge interventions. Methods: AgileNudge+ was developed through iterative processes integrating principles from behavioral economics and user-centered design. The content of AgileNudge+ operationalizes an Agile science–based process to efficiently design, embed, and disseminate evidence-based nudges that encourage positive behavior change without limiting choice. Using a mixed methods approach, we tested AgileNudge+ software’s ability to organize and simplify the nudge intervention process, allowing a diverse range of scholars with limited knowledge of Agile science to use nudges. Usability testing assessed the tool’s usefulness and interface with a sample of 18 health care professionals, each asked to interact with the software and create a nudge intervention to solve a problem within their professional project’s sphere. Results: The study was funded in August 2022, with data collection occurring from June 2023 to July 2024. As of July 2024, we have enrolled 18 participants. Quantitative results found a mean usefulness rating of AgileNudge+ of 3.83 (95% CI 3.00-4.66). Qualitative results highlighted ways to modify the language used in AgileNudge+ to be more comprehensible to a diverse user base and promoted modifications to the software that facilitate real-time assistance and prioritize time efficiency in user interactions. Feedback further supported the positive impact of gamification on participant motivation when using the software. Conclusions: AgileNudge+ is an effective assistive tool for simplifying the positive behavior change process using nudge interventions, with tailored content and interactions to meet users’ needs and demands. Building onto the current design, future iterations of AgileNudge+ will use artificial intelligence to process large volumes of data while reducing the time and mental energy required to scan for existing cognitive biases and nudge prototypes. The software is also being upgraded to build on current gamification efforts, encouraging more sustained motivation by increasing the temporal resolution of the digital interface. These modifications stay true to the agility and user-centered aspects of AgileNudge+, emphasizing the novelty of the constantly evolving software design process. %M 39302134 %R 10.2196/57390 %U https://formative.jmir.org/2024/1/e57390 %U https://doi.org/10.2196/57390 %U http://www.ncbi.nlm.nih.gov/pubmed/39302134 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e57873 %T An Exercise-Based Precision Medicine Tool and Smartphone App for Managing Achilles Tendinopathy (the 'PhysViz' System): User-Centered Development Study %A Merry,Kohle %A MacPherson,Megan M %A Whittaker,Jackie L %A Napier,Christopher %A Holsti,Liisa %A Scott,Alex %+ Department of Physical Therapy, University of British Columbia, 212 Friedman Building, 2177 Wesbrook Mall, Vancouver, BC, V6T 1Z3, Canada, 1 (604) 822 8225, kohle.merry@hiphealth.ca %K exercise therapy %K physical therapy modalities %K rehabilitation %K tendons %K tendinopathy %K mobile health %K mHealth %K mobile phone %D 2024 %7 13.11.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: People with Achilles tendinopathy (AT) experience persistent pain that can limit engagement with daily occupations and negatively impact mental health. Current therapeutic exercise approaches vary in success, with many people experiencing reinjury, leading to a cycle of chronic tendinopathy often lasting years. High-magnitude precision loading may help people exit this feedback cycle, but applying these principles clinically is challenging. Objective: This user-centered design case study aims to provide an overview on how the PhysViz (a prototype for a novel remote rehabilitation intervention for AT management) was developed and evaluated following the development phase of the Framework for Accelerated and Systematic Technology-Based Intervention Development and Evaluation Research (FASTER). Methods: The development process engaged a multidisciplinary team comprising people with AT experiences, clinicians, and engineers. It followed the 5 stages within the FASTER development phase: empathize, define, ideate, prototype, and test. The PhysViz development and evaluation were informed by needs assessments, surveys, literature reviews, validation studies, case studies, roundtable discussions, and usability testing (some of which have been published previously). The FASTER systematically guided the integration of evidence-based features and behavior change theory. Results: By using the FASTER and ensuring that the PhysViz system was underpinned by diverse stakeholder needs, this work resulted in the development of a working prototype for both the PhysViz physical exercise tool and the accompanying PhysViz software package (mobile app and web application). A variety of study designs informed user-desired features that were integrated into the PhysViz prototype, including real-time biofeedback in the form of precision load monitoring, customizable exercise programs, and pain tracking. In addition, clinicians can visualize client data longitudinally and make changes to client exercise prescriptions remotely based on objective data. The identified areas for improvement, such as upgrading the user interface and user experience and expanding clinical applications, provide valuable insights for future PhysViz iterations. Further research is warranted to assess the long-term efficacy and feasibility of the PhysViz in diverse clinical settings and its potential to improve AT symptoms. Conclusions: Being one of the first technology development initiatives guided by the FASTER, this study exemplifies a systematic and multidisciplinary approach to creating a remote rehabilitation intervention. By incorporating stakeholder feedback and evidence-based features, the PhysViz addresses key challenges in AT rehabilitation, offering a novel solution for precision loading and therapeutic exercise engagement. Positive feedback from users and clinicians underscores the potential impact of the PhysViz in improving AT management outcomes. The PhysViz serves as a model for technology-based intervention development, with potential implications for other tendinopathies and remote rehabilitation strategies. %M 39536312 %R 10.2196/57873 %U https://humanfactors.jmir.org/2024/1/e57873 %U https://doi.org/10.2196/57873 %U http://www.ncbi.nlm.nih.gov/pubmed/39536312 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e59329 %T Collaborative Care to Improve Quality of Life for Anxiety and Depression in Posttraumatic Epilepsy (CoCarePTE): Protocol for a Randomized Hybrid Effectiveness-Implementation Trial %A Munger Clary,Heidi M %A Snively,Beverly M %A Cagle,Christian %A Kennerly,Richard %A Kimball,James N %A Alexander,Halley B %A Brenes,Gretchen A %A Moore,Justin B %A Hurley,Robin A %+ Department of Neurology, Wake Forest University School of Medicine, 1 Medical Center Blvd., Winston-Salem, NC, 27157, United States, 1 3367167110, hmungerc@wakehealth.edu %K integrated care %K mental health %K seizures %K psychiatric comorbidity %K neurology clinic %K epilepsy %D 2024 %7 13.11.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Anxiety and depression in people with epilepsy are common and associated with poor outcomes; yet, they often go untreated due to poor mental health specialist access. Collaborative care is an integrated care model with a strong evidence base in primary care and medical settings, but it has not been evaluated in neurology clinics. Evaluating implementation outcomes when translating evidence-based interventions to new clinical settings to inform future scaling and incorporation into real-world practice is important. Objective: The Collaborative Care for Posttraumatic Epilepsy (CoCarePTE) trial aims to evaluate the effectiveness (improvement in emotional quality of life) and implementation of a collaborative care intervention for people with anxiety or depressive symptoms and posttraumatic epilepsy. Methods: CoCarePTE is a 2-site, randomized, single-blind, hybrid type 1 effectiveness-implementation trial that will randomize 60 adults to receive either neurology-based collaborative care or usual care. Adults receiving neurological care at participating centers with anxiety or depressive symptoms and a history of at least mild traumatic brain injury before epilepsy onset will be enrolled. The collaborative care intervention is a 24-week stepped-care model with video or telephone calls every 2 weeks by a care manager for measurement-based anxiety and depression care, seizure care monitoring, and brief therapy intervention delivery. This is supplemented by antidepressant prescribing recommendations by psychiatrists for neurologists via case conferences and care manager–facilitated team communication. In step 2 of the intervention, individuals with <50% symptom reduction by 10 weeks will receive an added 8-session remote cognitive behavioral therapy program. The study is powered to detect a moderate improvement in emotional quality of life. As a hybrid type 1 trial, effectiveness is the primary focus, with the primary outcome being a change in emotional quality of life at 6 months in the intervention group compared to control. Secondary effectiveness outcomes are 6-month changes in depression, anxiety, and overall quality of life. Implementation outcomes, including fidelity, acceptability, feasibility, and appropriateness, are evaluated before implementation and at 3 months. The primary effectiveness analysis will compare changes in emotional quality of life scores from baseline to 6 months between the intervention and control arms using multiple linear regression modeling, adjusting for study site and using an intent-to-treat approach. Results: Enrollment commenced in 2023, with modifications in the inclusion and exclusion made after the first 6 enrollees due to slow recruitment. Enrollment is expected to continue at least into early 2025. Conclusions: The CoCarePTE trial is novel in its use of a hybrid effectiveness-implementation design to evaluate an evidence-based mental health intervention in epilepsy, and by incorporating seizure care into a collaborative care model. If a significant improvement in emotional quality of life is found in the intervention group compared to usual care, this would support next step scaling or clinical implementation. Trial Registration: ClinicalTrials.gov NCT05353452; https://www.clinicaltrials.gov/study/NCT05353452 International Registered Report Identifier (IRRID): DERR1-10.2196/59329 %M 39535875 %R 10.2196/59329 %U https://www.researchprotocols.org/2024/1/e59329 %U https://doi.org/10.2196/59329 %U http://www.ncbi.nlm.nih.gov/pubmed/39535875 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e55137 %T Leveraging Implementation Science at the Early-Stage Development of a Novel Telehealth-Delivered Fear of Exercise Program to Understand Intervention Feasibility and Implementation Potential: Feasibility Behavioral Intervention Study %A Duran,Andrea T %A Cumella,Robin M %A Mendieta,Miguel %A Keener-Denoia,Adrianna %A López Veneros,David %A Farris,Samantha G %A Moise,Nathalie %A Kronish,Ian M %+ Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center, 622 West 168th Street, New York, NY, 10032, United States, 1 212 342 4491, atd2127@cumc.columbia.edu %K behavioral intervention development %K implementation science %K acute coronary syndrome %K exercise sensitivity %K interoceptive exposure %K digital health %K mobile phone %D 2024 %7 12.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: To increase real-world adoption of effective telehealth-delivered behavioral health interventions among midlife and older adults with cardiovascular disease, incorporating implementation science (IS) methods at earlier stages of intervention development may be needed. Objective: This study aims to describe how IS can be incorporated into the design and interpretation of a study assessing the feasibility and implementation potential of a technology-delivered behavioral health intervention. Methods: We assessed the feasibility and implementation potential of a 2-session, remotely delivered, home-based behavioral intervention composed of psychoeducation, interoceptive exposure through low-to-moderate intensity walking, interoceptive counseling, and homework (Reducing Exercise Sensitivity with Exposure Training; RESET) among patients with recent acute coronary syndrome (ACS) and some fear of exercise. To assess intervention feasibility, we measured patient protocol adherence, intervention delivery fidelity, and completion of intervention outcome assessments using direct observations, fidelity checklists, surveys, and device-measured physical activity. To assess implementation potential, we measured implementation outcomes (feasibility, acceptability, and appropriateness) using 4-item measures, each rated from the patient perspective on a 1 to 5 Likert scale (1=completely disagree and 5=completely agree; criteria: ≥4=agree or completely agree), and patient-perceived implementation determinants and design feedback using survey and interview data. Interview data underwent thematic analysis to identify implementation determinant themes, which were then categorized into Consolidated Framework for Implementation Research (CFIR) domains and constructs. Results: Of 31 patients approached during recruitment, 3 (10%) were eligible, enrolled, and completed the study (mean age 46.3, SD 14.0 y; 2/3, 67% male; 1/3, 33% Black; and 1/3, 33% Asian). The intervention was delivered with fidelity for all participants, and all participants completed the entire intervention protocol and outcome assessments. On average, participants agreed that the RESET intervention was feasible and acceptable, while appropriateness ratings did not meet implementation criteria (feasibility: mean 4.2, SD 0.4; acceptability: mean 4.3, SD 0.7; and appropriateness: mean 3.7, SD 0.4). Key patient-perceived implementation determinants were related to constructs in the innovation (design, adaptability, and complexity), inner setting (available resources [physical space, funding, materials, and equipment] and access to knowledge and information), and innovation recipient characteristics (motivation, capability, opportunity, and need) domains of the CFIR, with key barriers related to innovation design. Design feedback indicated that the areas requiring the most revisions were the interoceptive exposure design and the virtual delivery modality, and reasons why included low dose and poor usability. Conclusions: The RESET intervention was feasible but not implementable in a small sample of patients with ACS. Our theory-informed, mixed methods approach aided our understanding of what, how, and why RESET was not perceived as implementable; this information will guide intervention refinement. This study demonstrated how integrating IS methods early in intervention development can guide decisions regarding readiness to advance interventions along the translational research pipeline. %M 39531636 %R 10.2196/55137 %U https://formative.jmir.org/2024/1/e55137 %U https://doi.org/10.2196/55137 %U http://www.ncbi.nlm.nih.gov/pubmed/39531636 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e58363 %T A Novel Web App for Dietary Weight Management: Development, Implementation, and Usability Study %A Oliveira,Ashleigh %A Wolff,John %A Alfouzan,Nouf %A Yu,Jin %A Yahya,Asma %A Lammy,Kayla %A Nakamura,Manabu T %+ Division of Nutritional Sciences, University of Illinois at Urbana Champaign, 905 S Goodwin Ave, Urbana, IL, 61801, United States, 1 217 333 1267, oliveira.ashleigh@gmail.com %K health application %K weight loss %K behavior change technique %K BCT %K online weight loss program %K weight monitoring %K meal planning %K sustainable weight loss %K dietary fiber %K mHealth %K mobile health %D 2024 %7 11.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Online weight loss programs have ambiguous efficacy. There is a growing body of evidence that weight loss programs when combined with apps have better outcomes; however, many apps lack an evidence-based approach to dietary changes for weight loss and do not rely on a theoretical framework for behavior change. Objective: This study aimed to describe the development and the preliminary usability and acceptability testing of a web app that uses behavior change techniques (BCTs) to support users of a comprehensive online weight loss program. Methods: The weight loss program intervention components were nutrient and weight tracking charts that needed a remotely accessible and online format. The app was designed by nutrition researchers and developers in a collaborative effort. A review of BCTs in weight loss and web apps was performed as well as an assessment of user needs to inform the initial prototype. A preliminary app prototype, version 1.0, was provided to participants of a weight loss trial (N=30) to assess for feasibility of its use. A full app prototype, version 2.0, was feasibility and acceptability tested by trial participants (n=11) with formal feedback by Likert-scale survey and open-ended questions. In the final round of testing, a user group of scientists and developers (n=11) was selected to provide a structured 3-month review through which the group met weekly for collective feedback sessions. Results: The process resulted in a fully developed web app, MealPlot, by the Applied Research Institute, for meal planning and weight tracking that can be used by weight loss users and health professionals to track their patients. MealPlot includes a weight chart, a protein-fiber chart, and a chat feature. In addition, MealPlot has 2 distinct platforms, 1 for weight loss users and 1 for health professionals. Selected BCTs for incorporation into the app were goal setting, feedback, problem-solving, self-monitoring, and social support. Version 1.0 was used successfully to provide a functioning, online weight chart over the course of a 1-year trial. Version 2.0 provided a functional weight chart and meal planning page, but 8 out of 11 participants indicated MealPlot was difficult to use. Version 3.0 was developed based on feedback and strategies provided from user group testing. Conclusions: The web app, MealPlot, was developed to improve outcomes and functionality of an online weight loss program by providing a remote method of tracking weight, food intake, and connecting users to health professionals for consistent guidance that is not otherwise available in a traditional in-person health care setting. The final version 3.0 of the web app will be refined based on findings of a review study gathering feedback from health professionals and from actual weight loss users who are part of a clinical weight loss trial. %M 39527795 %R 10.2196/58363 %U https://formative.jmir.org/2024/1/e58363 %U https://doi.org/10.2196/58363 %U http://www.ncbi.nlm.nih.gov/pubmed/39527795 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e57664 %T A Personalized Data Dashboard to Improve Compliance with Ecological Momentary Assessments in College Students: Protocol for a Microrandomized Trial %A Lanza,Stephanie T %A Linden-Carmichael,Ashley N %A Wang,Danny %A Bhandari,Sandesh %A Stull,Samuel W %+ Department of Biobehavioral Health, Pennsylvania State University, 129 Biobehavioral Health Building, University Park, PA, 16802, United States, 1 814 865 7095, SLanza@psu.edu %K ecological momentary assessments %K data dashboard %K study compliance %K microrandomized trial %K intensive longitudinal data %K EMA %K adolescents %K substance use %K wearables %D 2024 %7 11.11.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Ecological momentary assessments (EMA) are ideal for capturing the dynamic nature of young adult substance use behavior in daily life and identifying contextual risk factors that signal higher-risk episodes. These methods could provide a signal to trigger real-time intervention delivery. Study compliance and engagement are common barriers to participation but may be improved by personalizing messages. This study compares compliance outcomes between one group of young adults receiving standard (generic) prompts at each assessment and another group that received additional personalization and an updated data dashboard (DD) showing study progress to date at 1 randomly selected prompt per day. Objective: The primary objectives are to (1) develop a real-time DD for giving participants personalized updates on their progress in the study and (2) examine its preliminary overall effects on study compliance and experiences. Secondary objectives are to identify person-, day-, and moment-level characteristics associated with study compliance and person-level characteristics associated with perceived usefulness of the DD. Methods: This is a protocol for Project ENGAGE, a 2-arm randomized controlled trial. Arm 1 (EMA group) is engaged in a standard EMA protocol, and arm 2 (EMA+DD group) is engaged in the same study but with additional personalization and feedback. Inclusion criteria are (1) previous participation in a recent college student survey about health behavior and mental health who indicated willingness to participate in future research studies and (2) indicated past-month alcohol use; lifetime marijuana, hashish, or Delta-8-tetrahydrocannabinol (THC) use; or some combination of these on that survey. All participants in this study completed a baseline survey; EMA at 11 AM, 2 PM, 5 PM, and 8 PM each day for 21 days; and an exit survey. Participants in arm 2 engaged in a microrandomized trial, receiving a personalized DD at 1 randomly selected prompt per day. Primary outcomes include whether a survey was completed, time to complete a survey, and subjective experiences in the study. Primary analyses will compare groups on overall study compliance and, for arm 2, use marginal models to assess the momentary effect of receiving 1 updated DD per day. Results: Approval was granted by the university’s institutional review board on February 8, 2023. Recruitment via direct email occurred on March 30 and April 6, 2023; data collection was completed by April 29, 2023. A total of 91 individuals participated in the study. Results have been accepted for publication in JMIR Formative Research. Conclusions: Results from the evaluation of this study will indicate whether providing (at randomly selected prompts) real-time, personalized feedback on a participant’s progress in an EMA study improves study compliance. Overall, this study will inform whether a simple, automated DD presenting study compliance and incentives earned to date may improve young adults’ compliance and engagement in intensive longitudinal studies. International Registered Report Identifier (IRRID): DERR1-10.2196/57664 %M 39527809 %R 10.2196/57664 %U https://www.researchprotocols.org/2024/1/e57664 %U https://doi.org/10.2196/57664 %U http://www.ncbi.nlm.nih.gov/pubmed/39527809 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e51900 %T Participation in eHealth Communication Interventions Among Patients Undergoing Hemodialysis: Scoping Review %A Deinboll,Anne %A Moe,Cathrine Fredriksen %A Ludvigsen,Mette Spliid %+ Faculty of Nursing and Health Sciences, Nord University, Pb 614, Mo i Rana, 8607, Norway, 47 75129709, anne.deinboll@nord.no %K eHealth %K electronic health records %K hemodialysis %K patient participation %K renal dialysis %K renal insufficiency %K chronic %K mobile phone %D 2024 %7 11.11.2024 %9 Review %J J Med Internet Res %G English %X Background: eHealth communication interventions have been shown to offer individuals with chronic kidney disease the opportunity to embrace dialysis therapies with greater confidence, the potential to obtain better clinical outcomes, and an increased quality of life. eHealth is an emerging field that offers diverse, flexible designs and delivery options. However, existing evidence on eHealth communication among patients undergoing hemodialysis is sparse and scattered and lacks systematization. Objective: This scoping review aims to identify and map the current evidence on patient participation in eHealth communication interventions. We aimed to map the associations between interventions and electronic health records, the participative role of individuals living with chronic kidney disease and undergoing hemodialysis, and the barriers to and facilitators of patient involvement in eHealth communication with health care professionals. Methods: This study used the Joanna Briggs Institute methodology for conducting a scoping review. Studies eligible for inclusion were those that included adult patients (aged >18 y) undergoing all types of hemodialysis, including prescheduled in-center hemodialysis and conventional home-based hemodialysis. Systematic searches were completed in Ovid MEDLINE, Ovid Embase, EBSCOhost CINAHL with Full Text, Scopus, and ProQuest Dissertations and Theses. Extracted data from the included studies were presented in figures and tables along with descriptions that responded to the research questions. This review was reported according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Results: In total, 9 peer-reviewed studies were included. The main result was a low participative patient role and a vaguely described link to electronic health records. The key participative facilitators were availability of and access to the intervention; security, trust, and confidence; patient knowledge of their health situation and use of self-care; and patient preparedness for an uncertain future health situation and the ability to relate to family and friends about it. The key participative barriers were lack of availability of and access to information, mistrust and lack of safety, lack of knowledge of health situation and self-care, and relational issues. All barriers and facilitators were related to health literacy. Conclusions: This scoping review summarizes 4 specific and 3 nonspecific eHealth communication interventions developed and evaluated in various studies involving patients receiving hemodialysis. A knowledge gap exists between low levels of patient participation in eHealth communication and patients’ limited access to electronic health records. eHealth communication interventions should implement patient participation and focus on the fact that different modalities of eHealth communication can complement face-to-face communication. International Registered Report Identifier (IRRID): RR2-10.2196/38615 %M 39527788 %R 10.2196/51900 %U https://www.jmir.org/2024/1/e51900 %U https://doi.org/10.2196/51900 %U http://www.ncbi.nlm.nih.gov/pubmed/39527788 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e56795 %T Effectiveness and Feasibility of Digital Pulmonary Rehabilitation in Patients Undergoing Lung Cancer Surgery: Systematic Review and Meta-Analysis %A Lu,Taiping %A Deng,Ting %A Long,Yangyang %A Li,Jin %A Hu,Anmei %A Hu,Yufan %A Ouyang,Li %A Wang,Huiping %A Ma,Junliang %A Chen,Shaolin %A Hu,Jiale %+ Nursing Department, Affiliated Hospital of Zunyi Medical University, Number 149, Dalian Road, Huichuan District, Zunyi, 563000, China, 86 13762910513, 30363284@qq.com %K app-based %K digital rehabilitation %K internet-based intervention %K lung cancer %K perioperative pulmonary rehabilitation %K systematic review %K telerehabilitation %D 2024 %7 11.11.2024 %9 Review %J J Med Internet Res %G English %X Background: Pulmonary rehabilitation (PR) has been shown to effectively support postsurgical recovery in patients with lung cancer (LC) at various stages. While digital PR programs offer a potential solution to traditional challenges, such as time and space constraints, their efficacy and feasibility for patients undergoing LC surgery remain unclear. Objective: This systematic review aims to assess the feasibility and effectiveness of digital PR programs for individuals undergoing LC surgery. Methods: A systematic review was conducted, retrieving data from 6 English and 4 Chinese databases from their inception to January 1, 2024. References in related studies were also manually reviewed. The primary outcomes assessed were physical capacity, lung function, and the incidence of postoperative pulmonary complications (PPCs). The secondary outcomes were compliance, hospital stay, chest tube duration, anxiety, depression, and quality of life. Where applicable, recruitment and withdrawal rates were also evaluated. Meta-analysis and descriptive analysis were used to assess the outcomes. Results: A total of 5 randomized controlled trials and 6 quasi-experimental studies (n=1063) were included, with 4 studies being included in the meta-analyses. Our meta-analyses revealed that digital PR reduced the decline in 6-minute walk distance (6-MWD) by an average of 15 m compared with routine PR programs from admission to discharge, demonstrating a clinically significant improvement in physical capacity (mean difference –15.00, 95% CI –25.65 to –4.34, P=.006). Additionally, digital PR was associated with a reduction (26/58, 45%) in the likelihood of PPCs (risk ratio 0.45, 95% CI 0.30-0.66, P<.001) and a reduction of 1.53 days in chest tube duration (mean difference –1.53, 95% CI –2.95 to –0.12, P=.03), without a statistically significant effect on postoperative hospital stay (mean difference –1.42, 95% CI –3.45 to 0.62, P=.17). Descriptive analyses suggested that digital PR has the potential to improve knowledge, lung function, quality of life, and self-efficacy, while reducing depression and anxiety. Notably, digital PR was found to be a safe, feasible, and acceptable supplementary intervention. Despite challenges with low recruitment, digital PR enhanced exercise compliance, increased patient satisfaction, and lowered dropout rates. Conclusions: This systematic review is the first comprehensive analysis to suggest that digital PR is a safe, feasible, acceptable, and effective intervention for promoting recovery in patients with LC after surgery. Digital PR has the potential to be a valuable supplement, expanding access to traditional PR programs. Future research should prioritize the development of interactive and inclusive digital solutions tailored to diverse age groups and educational backgrounds. Rigorous studies, including large-scale, high-quality randomized controlled trials with detailed protocols and robust methodologies, are needed to assess the short-, medium-, and long-term efficacy of digital PR, ensuring reproducibility in future research. Trial Registration: PROSPERO CRD42023430271; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=430271 %M 39527799 %R 10.2196/56795 %U https://www.jmir.org/2024/1/e56795 %U https://doi.org/10.2196/56795 %U http://www.ncbi.nlm.nih.gov/pubmed/39527799 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e58641 %T Older Adults’ Perspectives and Experiences With Digital Health in Singapore: Qualitative Study %A Leong,Qiao Ying %A Lee,V Vien %A Ng,Wei Ying %A Vijayakumar,Smrithi %A Lau,Ni Yin %A Mauritzon,Ingela %A Blasiak,Agata %A Ho,Dean %+ The Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, National University of Singapore, Centre for Life Sciences, 28 Medical Drive, #05-COR, Singapore, 117456, Singapore, 65 6601 7515, biedh@nus.edu.sg %K digital health %K gerontology %K geriatrics %K elder %K aging %K Singapore %K qualitative %K mHealth %K mobile health %K experience %K technology use %K interview %K perspective %K acceptance %K technology adoption %D 2024 %7 11.11.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Technology use among older adults is increasingly common. Even though there is potential in leveraging technology to help them manage their health, only a small fraction of them use it for health-related purposes. Objective: This study seeks to understand the perspectives of and experiences with digital health (DH) among older adults in Singapore. Methods: A total of 16 participants (age range 60-80 years; n=11, 69% female) were interviewed for approximately an hour (range 27-64 minutes) about their health, DH use, and DH experiences. The interviews were recorded, transcribed verbatim, and thematically analyzed. Results: Five main themes emerged from the interview: support in developing DH literacy, credibility, cost and benefit considerations, intrinsic drive to be healthy, and telehealth. Older adults need support in familiarizing themselves with DH. When considering DH options, older adults often relied on credible sources and preferred DH to be free. Monetary incentives were brought up as motivators. The intrinsic drive to live longer and healthily was expressed to be a huge encouragement to use DH to help obtain health-related knowledge and achieve healthy living goals. The idea of telehealth was also appealing among older adults but was seen to be more suited for individuals who have issues accessing a physical clinic. Conclusions: Our findings offer insights into the various aspects that matter to older adults in the adoption of DH, which in turn can help reshape their health-seeking behavior and lifestyle. As such, policy makers and DH implementors are encouraged to take these into consideration and align their strategies accordingly. %M 39527787 %R 10.2196/58641 %U https://humanfactors.jmir.org/2024/1/e58641 %U https://doi.org/10.2196/58641 %U http://www.ncbi.nlm.nih.gov/pubmed/39527787 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54585 %T Scalable Technology for Adolescents and Youth to Reduce Stress in the Treatment of Common Mental Disorders in Jordan: Protocol for a Randomized Controlled Trial %A Akhtar,Aemal %A de Graaff,Anne Marijn %A Habashneh,Rand %A Keyan,Dharani %A Abualhaija,Adnan %A Fanatseh,Sarah %A Faroun,Muhannad %A Aqel,Ibrahim Said %A Dardas,Latefa %A Servili,Chiara %A van Ommeren,Mark %A Bryant,Richard %A Carswell,Kenneth %+ Department of Mental Health Brain health and Substance Use, World Health Organization, Avenue Appia 20, Geneva, 1211, Switzerland, 41 792493513, degraaffa@who.int %K mHealth %K psychosocial intervention %K youths %K depression %K anxiety %K minimally guided digital intervention %K low- and middle-income countries %K barriers %K access %K mental health %K digital self-help %K chatbots %K conversational agents %K effectiveness %K Scalable Technology for Adolescents and Youth to Reduce Stress %K randomized controlled trial %K Jordan %K psychological distress %K mental disorders %K disability %D 2024 %7 8.11.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Young people in low- and middle-income countries encounter significant barriers to accessing mental health support due to various factors, including a substantial treatment gap and limited health care budgets allocated to mental health. Using innovative strategies, such as scalable digital self-help psychological interventions, offers a potential solution for improving access to mental health support. However, digital mental health interventions come with their own set of challenges, including issues related to low user engagement. Chatbots, with their interactive and engaging nature, may present a promising avenue for the delivery of these interventions. Objective: This study aims to explore the effectiveness of a newly developed World Health Organization (WHO) digital mental health intervention, titled Scalable Technology for Adolescents and Youth to Reduce Stress (STARS). Methods: A single-blind, 2-arm randomized controlled trial will be conducted nationally across Jordan. Participants will include 344 young adults, aged 18-21 years, currently residing in Jordan. Inclusion criteria are heightened levels of psychological distress as determined through the 10-item Kessler Psychological Distress Scale (≥20). Assessment measures will be conducted at baseline, 1-week post intervention, and 3-month follow-up. Following baseline assessments, eligible participants will be randomized to receive STARS or enhanced usual care. The primary outcomes are the reduction of symptoms of depression and anxiety (Hopkins Symptom Checklist, 25 subscales) at 3-month follow-up. Secondary outcomes include general functioning (WHO Disability Assessment Schedule 2.0), well-being (WHO-5 Well-Being Index), personal problems (Psychological Outcomes Profile), and agency (State Hope Scale subscale). Results: The study was funded in January 2020 by the Research for Health in Humanitarian Crises Programme (Elhra) and recruitment for the trial started on July 16, 2023. As of November 15, 2023, we randomized 228 participants. Conclusions: This trial intends to contribute to the growing digital mental health evidence base by exploring technological solutions to address global public health challenges. Given the widespread use of technology globally, even in resource-constrained settings, and the high adoption rates among adolescents and young individuals, digital initiatives such as STARS present promising opportunities for the future of mental health care in low- and middle-income countries. Trial Registration: ISRCTN Registry ISRCTN10152961; https://www.isrctn.com/ISRCTN10152961 International Registered Report Identifier (IRRID): DERR1-10.2196/54585 %M 39514860 %R 10.2196/54585 %U https://www.researchprotocols.org/2024/1/e54585 %U https://doi.org/10.2196/54585 %U http://www.ncbi.nlm.nih.gov/pubmed/39514860 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e64540 %T Preliminary Feasibility of a Novel Mind-Body Program to Prevent Persistent Concussion Symptoms Among Young Adults With Anxiety: Nonrandomized Open Pilot Study %A Becker,Molly Elizabeth %A Stratton Levey,Nadine %A Yeh,Gloria Y %A Giacino,Joseph %A Iverson,Grant %A Silverberg,Noah %A Parker,Robert A %A McKinnon,Ellen %A Siravo,Caitlin %A Shah,Priyanca %A Vranceanu,Ana-Maria %A Greenberg,Jonathan %+ Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, 1 Bowdoin Square, Suite 648, Boston, MA, 02114, United States, 1 6176439402, jgreenberg5@mgh.harvard.edu %K concussions %K mind-body %K preventions %K young adults %K feasibility %K persistence %K open pilot %K mind-body program %K preliminary feasibility %K mild traumatic brain injuries %K United States %K adults %K psychological factors %K mind-body interventions %D 2024 %7 8.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Concussions are common, particularly among young adults, and often are associated with persistent, debilitating, and hard-to-treat symptoms. Anxiety and concussion symptoms often amplify each other, and growing evidence indicates that anxiety plays a key role in symptoms persistence after concussion. Targeting anxiety early after concussion may be a promising means of helping prevent persistent concussion symptoms in this population. We developed the Toolkit for Optimal Recovery after Concussion (TOR-C), the first mind-body program tailored for young adults with a recent concussion and anxiety, aiming to prevent persistent concussion symptoms. Objective: This study aims to conduct an open pilot of TOR-C to test preliminary feasibility, signal of change in measures, and treatment perceptions. Methods: Five young adults (aged 18-24 years) attended 4 weekly one-on-one live video sessions with a clinician. Participants completed questionnaires measuring treatment targets (ie, pain catastrophizing, mindfulness, fear avoidance, limiting behaviors, and all-or-nothing behaviors) and outcomes (ie, postconcussive symptoms, physical function, anxiety, depression, and pain) at baseline, immediately following the intervention, and 3 months after intervention completion. At the conclusion of the program, participants attended a qualitative interview and provided feedback about the program to help optimize study content and procedures. Results: Feasibility markers were excellent for credibility and expectancy (5/5, 100% of participants scored above the credibility and expectancy scale midpoint), client satisfaction (4/5, 80% of participants scored above the Client Satisfaction Questionnaire midpoint), therapist adherence (97% adherence), acceptability of treatment (5/5, 100% of participants attended 3 or more sessions), adherence to homework (87% home practice completion), and feasibility of assessments (no measures fully missing). The feasibility of recruitment was good (5/7, 71% of eligible participants agreed to participate). There were preliminary signals of improvements from pre-post comparisons in treatment targets (d=0.72-2.20) and outcomes (d=0.41-1.38), which were sustained after 3 months (d=0.38-2.74 and d=0.71-1.63 respectively). Exit interviews indicated overall positive perceptions of skills and highlighted barriers (eg, busyness) and facilitators (eg, accountability) to engagement. Conclusions: TOR-C shows preliminary feasibility, is associated with a signal of improvement in treatment targets and outcomes, and has the potential to support recovery from concussion. The quantitative findings along with the qualitative feedback obtained from the exit interviews will help optimize TOR-C in preparation for an upcoming randomized controlled trial of TOR-C versus an active control condition of health education for concussion recovery. International Registered Report Identifier (IRRID): RR2-10.2196/25746 %M 39514283 %R 10.2196/64540 %U https://formative.jmir.org/2024/1/e64540 %U https://doi.org/10.2196/64540 %U http://www.ncbi.nlm.nih.gov/pubmed/39514283 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e59158 %T A Web-Based Intervention to Support a Growth Mindset and Well-Being in Unemployed Young Adults: Development Study %A Straand,Ingjerd J %A Følstad,Asbjørn %A Wünsche,Burkhard C %+ Department of Social Work, University of Stavanger, Kjell Arholms hus, Kjell Arholms gate 41, Stavanger, 4021, Norway, 47 93222289, ingjerd.j.straand@uis.no %K web-based intervention %K positive psychology %K mental health %K user experience %K persuasive design %D 2024 %7 8.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Engaging young adults in the labor market is vital for economic growth and well-being. However, the path to employment often presents setbacks that impact motivation and psychological functioning. Research suggests exploring positive psychology interventions in job-seeking and scaling the delivery of these using technology. However, dropout rates are high for self-administered psychological interventions on digital platforms. This challenge needs to be addressed for such platforms to be effective conveyors of psychological interventions. This study addresses this challenge by exploring user-oriented methods and proposes persuasive features for the design and development of a new web-based intervention targeting young unemployed adults. Objective: This study aims to provide an overview of a new positive psychology wise intervention, including its theoretical underpinnings and human-centered design methodology, targeting young, unemployed adults. Methods: Researchers collaborated with designers, developers, and stakeholders to design a web-based positive psychology intervention that leverages evidence-based wise interventions. Key improvements and adaptations were explored through formative usability testing with 13 unemployed young adults aged between 18 and 25 years (the target population). Qualitative usability testing data were collected, analyzed, and integrated into the ongoing design process as iterative improvements. Results: The result of this study is a modular intervention web application named RØST, designed to align with the user needs and the preferences of the specific end-user group of unemployed young adults. During the project, this application evolved from early concept sketches and prototypes into a developed solution ready for further testing and use. Insights from both end-user feedback and rich user observation gained in the study were used to refine the content and the design. To increase targeted end users’ motivation, persuasive design features including praise, rewards, and reminders were added. The web application was designed primarily to be used on mobile phones using text messaging for reminders. The development process included technical and data protection considerations. Conclusions: This study offers valuable insights into developing psychological or behavioral interventions to support unemployed young adults by documenting the design process and the adaptation and combination of diverse theoretical and empirical foundations. Involving stakeholders and end users in the development enabled relatable content development and resolved potential usability problems. An essential implication is the finding that end-user feedback and insights are crucial in shaping interventions. However, we experienced tensions between the evidence-based interventions and the human-centered design approaches. These tensions were not resolved and highlighted a need for ongoing user motivation support through monetary rewards, which were incorporated into the final web app design. %M 39514255 %R 10.2196/59158 %U https://formative.jmir.org/2024/1/e59158 %U https://doi.org/10.2196/59158 %U http://www.ncbi.nlm.nih.gov/pubmed/39514255 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e56437 %T Virtual Coach–Guided Online Acceptance and Commitment Therapy for Chronic Pain: Pilot Feasibility Randomized Controlled Trial %A Reilly,Erin D %A Kelly,Megan M %A Grigorian,Hannah L %A Waring,Molly E %A Quigley,Karen S %A Hogan,Timothy P %A Heapy,Alicia A %A Drebing,Charles E %A Volonte,Matias %A Kathawalla,Ummul-Kiram %A Robins,Hannah E %A Bernice,Katarina %A Bickmore,Timothy %+ Mental Illness Research, Education, and Clinical Center, Veteran Affairs Bedford Healthcare System, Department of Veteran Affairs, 200 Springs Road, Bedford, MA, 01730, United States, 1 781 687 4191, erin.reilly@va.gov %K chronic pain %K randomized controlled trial %K usability %K acceptance and commitment therapy %K embodied conversational agent %K veterans %D 2024 %7 8.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Veterans are disproportionately affected by chronic pain, with high rates of pain diagnoses (47%-56%) and a 40% higher rate of prevalence of severe pain than nonveterans. This is often accompanied by negative functional outcomes and higher mortality. Combined with research suggesting medical treatments for chronic pain are often insufficient, there is an urgent need for nonmedical pain self-management programs. An interactive online platform to deliver an efficacious treatment for chronic pain such as acceptance and commitment therapy (ACT) could be a valuable option to assist veterans with pain care at home. Objective: This study aims to evaluate the virtual coach–guided Veteran ACT for Chronic Pain (VACT-CP) online program compared to a waitlist and treatment as usual (WL+TAU) control group through a small pilot feasibility randomized controlled trial. The primary aim was to evaluate the feasibility and acceptability of VACT-CP and study procedures, such as ease of recruitment, treatment receptivity, attrition and retention, sustained participation, system usability, and assessment of trial procedures. Secondary aims explored differences in the VACT-CP and WL+TAU groups on pre- and posttest (week 7) outcome measures for pain, mental health, functioning, and ACT processes. Methods: Veterans with chronic pain were recruited and randomized to either the VACT-CP (n=20) or the WL+TAU (n=22) group in a parallel group trial design. Self-report surveys were administered to participants at baseline (week 0), at the intervention midpoint (week 3), immediately after the intervention (week 7), and at the 1-month follow-up (week 11). We used Wilcoxon signed rank tests with the intention-to-treat sample to describe changes in secondary outcomes from pre- to postintervention within each group. Results: Study procedures showed good feasibility related to recruitment, enrollment, randomization, and study completion rates. Participants reported that VACT-CP was easy to use (System Usability Scale: mean 79.6, SD 12.8; median 82.5, IQR 70-87.5); they completed an average of 5 of the 7 total VACT-CP modules with high postintervention satisfaction rates. Qualitative feedback suggested a positive response to program usability, content tailoring, veteran centeredness, and perceived impact on pain management. Although the pilot feasibility trial was not powered to detect differences in clinical outcomes and significant findings should be interpreted with caution, the VACT-CP group experienced significant increases in chronic pain acceptance (P<.001) and decreases in depressive symptoms (P=.03). Conclusions: VACT-CP showed encouraging evidence of feasibility, usability, and acceptance, while also providing promising initial results in improving a key process in ACT for chronic pain—chronic pain acceptance—after online program use. A full-scale efficacy trial is needed to assess changes in clinical outcomes. Trial Registration: ClinicalTrials.gov NCT03655132; http://clinicaltrials.gov/ct2/show/NCT03655132 International Registered Report Identifier (IRRID): RR2-10.2196/45887 %M 39514264 %R 10.2196/56437 %U https://formative.jmir.org/2024/1/e56437 %U https://doi.org/10.2196/56437 %U http://www.ncbi.nlm.nih.gov/pubmed/39514264 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e51832 %T Exploring Psychotherapists’ Attitudes on Internet- and Mobile-Based Interventions in Germany: Thematic Analysis %A Hildebrand,Anne Sophie %A Planert,Jari %A Machulska,Alla %A Margraf,Lena Maria %A Roesmann,Kati %A Klucken,Tim %+ Department of Clinical Psychology and Psychotherapy, University of Siegen, Obergraben 23, Siegen, 57072, Germany, 49 271 740 3688, Anne.Hildebrand@uni-siegen.de %K eHealth %K psychotherapy %K psychotherapists’ perspectives %K thematic analysis %K internet- and mobile-based intervention %D 2024 %7 7.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: In recent years, internet- and mobile-based interventions (IMIs) have become increasingly relevant in mental health care and have sparked societal debates. Psychotherapists’ perspectives are essential for identifying potential opportunities for improvement, facilitating conditions, and barriers to the implementation of these interventions. Objective: This study aims to explore psychotherapists’ perspectives on opportunities for improvement, facilitating conditions, and barriers to using IMIs. Methods: The study used a qualitative research design, utilizing open-ended items in a cross-sectional survey. A total of 350 psychotherapists were asked to provide their written opinions on various aspects of IMIs. Thematic analysis was conducted to analyze the data and identify core themes. Results: The analysis revealed 11 core themes related to the use of IMIs, which were categorized into 4 superordinate categories: “Applicability,” “Treatment Resources,” “Technology,” and “Perceived Risks and Barriers.” While many psychotherapists viewed IMIs as a valuable support for conventional psychotherapy, they expressed skepticism about using IMIs as a substitute. Several factors were perceived as hindrances to the applicability of IMIs in clinical practice, including technological issues, subjective concerns about potential data protection risks, a lack of individualization due to the manualized nature of most IMIs, and the high time and financial costs for both psychotherapists and patients. They expressed a desire for easily accessible information on evidence and programs to reduce the time and effort required for training and advocated for this information to be integrated into the conceptualization of new IMIs. Conclusions: The findings of this study emphasize the importance of considering psychotherapists’ attitudes in the development, evaluation, and implementation of IMIs. This study revealed that psychotherapists recognized both the opportunities and risks associated with the use of IMIs, with most agreeing that IMIs serve as a tool to support traditional psychotherapy rather than as a substitute for it. Furthermore, it is essential to involve psychotherapists in discussions about IMIs specifically, as well as in the development of new methodologies in psychotherapy more broadly. Overall, this study can advance the use of IMIs in mental health care and contribute to the ongoing societal debate surrounding these interventions. %M 39510514 %R 10.2196/51832 %U https://formative.jmir.org/2024/1/e51832 %U https://doi.org/10.2196/51832 %U http://www.ncbi.nlm.nih.gov/pubmed/39510514 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e56201 %T Facilitating Thought Progression to Reduce Depressive Symptoms: Randomized Controlled Trial %A Yatziv,Shai-Lee %A Pedrelli,Paola %A Baror,Shira %A DeCaro,Sydney Ann %A Shachar,Noam %A Sofer,Bar %A Hull,Sunday %A Curtiss,Joshua %A Bar,Moshe %+ The Leslie and Susan Gonda Brain Science Center, Bar- Ilan University Building number 901, Ramat-Gan, 5290002, Israel, 972 35317795, moshe.bar@biu.ac.il %K depression %K cognitive neuroscience %K facilitating thought progression %K FTP %K mobile phone %K digital health %K gamification %K depression symptoms %K randomized controlled trial %K RCT %K app %K depressive disorder %K web-based platforms %K effectiveness %D 2024 %7 7.11.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: The constant rise in the prevalence of major depressive disorder calls for new, effective, and accessible interventions that can rapidly and effectively reach a wide range of audiences. Recent developments in the digital health domain suggest that dedicated online platforms may potentially address this gap. Focusing on targeting ruminative thought, a major symptomatic hallmark of depression, in this study we hypothesized that delivering a digital health–based intervention designed to systematically facilitate thought progression would substantially alleviate depression. Objective: The study aims to investigate the efficacy of a novel digital intervention on the reduction of depressive symptoms. This intervention was designed as an easy-to-use gamified app specifically aimed to facilitate thought progression through intense practicing of associative, semantically broad, fast, and creative thought patterns. Methods: A randomized clinical trial was conducted, comparing changes in depression symptoms between participants who used the app in the intervention group (n=74) and waitlist control group (n=27) over the course of 8 weeks. All participants filled out a battery of clinical questionnaires to assess the severity of depression at baseline and 4 and 8 weeks after starting the study. These primarily included the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Patient Health Questionnaire-9 as well as the Positive Affect Negative Affect Scale-Negative Affect Score, Ruminative Response Scale, and Symptoms of Depression Questionnaire. Additional questionnaires were implemented to assess anxiety, positive affect, anhedonia, and quality of life. Results: The results indicate that across multiple clinical measurements, participants in the intervention group who played the gamified app showed greater and faster improvement in depressive symptoms compared with their waitlist control counterparts. The difference between the groups in MADRS improvement was –7.01 points (95% CI –10.72 to –3.29; P<.001; Cohen d=0.67). Furthermore, the difference in improvement between groups persisted up to 4 weeks posttrial (MADRS differences at week 12: F49,2=6.62; P=.003; ηp2=0.21). At the end of the trial, participants who played the app showed high interest in continuing using the app. Conclusions: The results demonstrate that a gamified app designed to facilitate thought progression is associated with improvement in depressive symptoms. Given its innovative and accessibility features, this gamified method aiming to facilitate thought progression may successfully complement traditional treatments for depression in the future, providing a safe and impactful way to enhance the lives of individuals experiencing depression and anxiety. Trial Registration: ClinicalTrials.gov NCT05685758; https://clinicaltrials.gov/study/NCT05685758 %M 39350528 %R 10.2196/56201 %U https://www.jmir.org/2024/1/e56201 %U https://doi.org/10.2196/56201 %U http://www.ncbi.nlm.nih.gov/pubmed/39350528 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e48696 %T Predictors of Engagement in Multiple Modalities of Digital Mental Health Treatments: Longitudinal Study %A Nowels,Molly Aideen %A McDarby,Meghan %A Brody,Lilla %A Kleiman,Evan %A Sagui Henson,Sara %A Castro Sweet,Cynthia %A Kozlov,Elissa %+ Division of Geriatrics and Palliative Medicine, Weill Cornell Medicine, 525 E 68th St, New York, NY, 10065, United States, 1 212 746 4888, mon2007@med.cornell.edu %K digital health %K mental health %K health care benefit %K prediction %K technology %K digital mental health %K employer-based %K teletherapy %K coaching %K utilization %K mobile phone %D 2024 %7 7.11.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Technology-enhanced mental health platforms may serve as a pathway to accessible and scalable mental health care; specifically, those that leverage stepped care models have the potential to address many barriers to patient care, including low mental health literacy, mental health provider shortages, perceived acceptability of care, and equitable access to evidence-based treatment. Driving meaningful engagement in care through these platforms remains a challenge. Objective: This study aimed to examine predictors of engagement in self-directed digital mental health services offered as part of an employer-based mental health benefit that uses a technology-enabled care platform. Methods: Using a prospective, longitudinal design, we examined usage data from employees who had access to an employer-sponsored mental health care benefit. Participants had access to a digital library of mental health resources, which they could use at any time, including daily exercises, interactive programs, podcasts, and mindfulness exercises. Coaching and teletherapy were also available to. The outcome was engagement with the self-directed digital mental health resources, measured by the number of interactions. Poisson regression models included sociodemographic characteristics, patient activation, mental health literacy, well-being, PHQ-9 and GAD-7 scores at baseline, primary concern for engaging in treatment, and the use of coaching or teletherapy sessions. Results: In total 950 individuals enrolled in the study, with 38% using any self-directed digital mental health resources. Approximately 44% of the sample did not use the app during the study period. Those using both self-directed digital and 1:1 modalities made up about one-quarter of the sample (235/950, 24.7%). Those using only coaching or therapy (170/950, 17.9%) and those using only self-directed digital mental health resources (126/950, 13.3%) make up the rest. At baseline, these groups statistically significantly differed on age, PHQ-9, GAD-7, MHLS, and primary concern. Receipt of coaching and teletherapy was associated with the number of self-directed digital mental health resources interactions in adjusted Poisson regression modeling. Use of any coach visit was associated with 82% (rate ratio [RR] 1.82, 95% CI 1.63-2.03) more self-directed digital mental health resource interactions while use of any teletherapy session was associated with 80% (RR 1.80, 95% CI 1.55-2.07) more digital mental health resources interactions (both P<.001). Each additional year of age was associated with increased digital mental health resources interactions (RR 1.04, 95% CI (1.03-1.05), and women had 23% more self-directed digital resources interactions than men (RR 1.23, 95% CI 1.09-1.39). Conclusions: Our key finding was that the use of coaching or teletherapy was associated with increased self-directed digital mental health resource use. Higher self-directed digital resource engagement among those receiving coaching or therapy may be a result of provider encouragement. On the other hand, when a participant engages with 1 modality in the platform, they may be more likely to begin engaging with others, becoming “super users” of all resources. %R 10.2196/48696 %U https://www.jmir.org/2024/1/e48696 %U https://doi.org/10.2196/48696 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e59897 %T Exploring the Needs of People With Chronic Low Back Pain and Health Care Professionals for mHealth Devices to Support Self-Managed Physical Activity and Pain: User-Centered Design Approach %A Berger,Mathilde %A Deblock-Bellamy,Anne %A Chèze,Laurence %A Robert,Thomas %A Desrosiers,Julie J %A Christe,Guillaume %A Bertrand,Anne Martine %+ Department of Occupational Therapy, University of Applied Sciences and Arts Western Switzerland (HETSL | HES-SO), Chemin des Abeilles 14, Lausanne, 1010, Switzerland, 41 (0)216510330, mathilde.berger@hetsl.ch %K chronic low back pain %K needs %K self-management %K physical activity %K mobile health %K mHealth %K user-centered design %D 2024 %7 7.11.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Chronic low back pain (CLBP) is a major economic and social problem worldwide. Despite the variety of recommended treatments, long-term self-management of this condition is complex and requires the development of innovative interventions. Mobile health (mHealth) technologies hold great promise for the management of chronic pain, particularly to support physical activity. However, their implementation is challenged by a lack of user compliance and limited engagement, which may be due to insufficient consideration of the needs of potential users during development. Objective: This study aims to explore the needs of people with CLBP and health care professionals regarding mHealth technologies to support self-managed physical activity, and to delineate design recommendations based on identified needs. Methods: A participatory study was conducted using a 3-phase, user-centered design approach: needs investigation with a group of experts in a workshop (phase 1), needs exploration with end users in focus groups (phase 2), and validation of needs using Delphi questionnaires followed by the development of a set of recommendations (phase 3). Results: A total of 121 people with CLBP, expert patients, health care professionals, rehabilitation researchers, and biomechanical engineers participated in this study. The results indicated how technology could help people with CLBP overcome their difficulties with managing physical activity. Specific needs were formulated concerning device objectives, expected strategies, functionalities, technical features, conditions of use, and potential facilitators and barriers to use. These needs were validated by consensus from the potential end users and translated into design recommendations. Conclusions: This study provides design recommendations for the development of an mHealth device specifically adapted for people with CLBP. %M 39509701 %R 10.2196/59897 %U https://humanfactors.jmir.org/2024/1/e59897 %U https://doi.org/10.2196/59897 %U http://www.ncbi.nlm.nih.gov/pubmed/39509701 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e57165 %T Insights From the Development of a Dynamic Consent Platform for the Australians Together Health Initiative (ATHENA) Program: Interview and Survey Study %A Xiong,Eddy %A Bonner,Carissa %A King,Amanda %A Bourne,Zoltan Maxwell %A Morgan,Mark %A Tolosa,Ximena %A Stanton,Tony %A Greaves,Kim %+ The Australians Together Health Initiative Program (The ATHENA Program), Sunshine Coast University Hospital, Queensland Health, 6 Doherty Street, Birtinya, Queensland, 4575, Australia, 61 0427389900, kim.greaves@health.qld.gov.au %K dynamic consent %K research %K clinical trials %K consumer engagement %K digital consent %K development %K decision making %K decision %K feedback %K user platform %K users %K communication %D 2024 %7 6.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Dynamic consent has the potential to address many of the issues facing traditional paper-based or electronic consent, including enrolling informed and engaged participants in the decision-making process. The Australians Together Health Initiative (ATHENA) program aims to connect participants across Queensland, Australia, with new research opportunities. At its core is dynamic consent, an interactive and participant-centric digital platform that enables users to view ongoing research activities, update consent preferences, and have ongoing engagement with researchers. Objective: This study aimed to describe the development of the ATHENA dynamic consent platform within the framework of the ATHENA program, including how the platform was designed, its utilization by participants, and the insights gained. Methods: One-on-one interviews were undertaken with consumers, followed by a workshop with health care staff to gain insights into the dynamic consent concept. Five problem statements were developed, and solutions were posed, from which a dynamic consent platform was constructed, tested, and used for implementation in a clinical trial. Potential users were randomly recruited from a pre-existing pool of 615 participants in the ATHENA program. Feedback on user platform experience was gained from a survey hosted on the platform. Results: In the 13 consumer interviews undertaken, participants were positive about dynamic consent, valuing privacy, ease of use, and adequate communication. Motivators for registration were feedback on data usage and its broader community benefits. Problem statements were security, trust and governance, ease of use, communication, control, and need for a scalable platform. Using the newly constructed dynamic consent platform, 99 potential participants were selected, of whom 67 (68%) were successfully recontacted. Of these, 59 (88%) agreed to be sent the platform, 44 (74%) logged on (indicating use), and 22 (57%) registered for the clinical trial. Survey feedback was favorable, with an average positive rating of 78% across all questions, reflecting satisfaction with the clarity, brevity, and flexibility of the platform. Barriers to implementation included technological and health literacy. Conclusions: This study describes the successful development and testing of a dynamic consent platform that was well-accepted, with users recognizing its advantages over traditional methods of consent regarding flexibility, ease of communication, and participant satisfaction. This information may be useful to other researchers who plan to use dynamic consent in health care research. %M 39504120 %R 10.2196/57165 %U https://formative.jmir.org/2024/1/e57165 %U https://doi.org/10.2196/57165 %U http://www.ncbi.nlm.nih.gov/pubmed/39504120 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e50456 %T Codesigning a Digital Type 2 Diabetes Risk Communication Tool in Singapore: Qualitative Participatory Action Research Approach %A Hashim,Jumana %A Luna Puerta,Lidia %A Foong,Pin Sym %A Tai,E Shyong %A Yi,Huso %A Smith,Helen Elizabeth %+ Saw Swee Hock School of Public Health, National University of Singapore, 12 Science Drive 2, Tahir Foundation Building, Singapore, 117549, Singapore, 65 66012499, jhashim@nus.edu.sg %K type 2 diabetes %K risk perception %K co-design %K risk communication tool %K diabetes prevention %D 2024 %7 5.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Diabetes is a serious public health concern worldwide. Despite public health efforts encouraging early screening and improving knowledge of effective interventions for those at increased risk of type 2 diabetes (T2D), the incorporation of preventative behaviors into an individual’s daily life remains suboptimal. Successfully and accurately increasing risk perception has been demonstrated to increase behavioral intention. Objective: The study aims to codesign a T2D risk communication tool by engaging public participants to (1) identify key characteristics that contribute to an effective risk communication tool and (2) test and iterate to develop a culturally sensitive and meaningful risk communication tool that can motivate T2D preventative behaviors. Methods: We adopted a novel methodology, “Patient and Public Involvement (PPI) Hawkers,” where we approached patrons at hawker centers and public eateries frequented by all local residents to evaluate and test 3 prototypes for the tool. The three prototypes were (1) “Diabetes Onset”—estimated age of diabetes onset of T2D based on one’s risk factors, (2) “Relative Risk”—the relative risk of T2D is presented in a 1-10 scale indicating where one’s risk score lie in relation to others, and (3) “Metabolic Age”—the median age of the risk category based on one’s risk factors, presented to be compared against their chronological age. We gathered reactions and feedback through rapid testing and iteration to understand which risk result presentation would be received the best. All the collected data were revisited and analyzed using an inductive thematic analysis to identify the key characteristics contributing to an effective risk communication tool. Results: We engaged with 112 participants (female: n=59, 56%) across 6 hawker centers. The key characteristics that were important to participants emerged in four main themes: (1) appeal and user experience, in terms of format and readability; (2) trust and validity of the institution providing the tool and the accuracy of the risk result; (3) threat appraisal: salience of risk information, which influenced their risk perception; and (4) coping appraisal: facilitators for behavior change, which impacted their intention for implementing T2D preventative behaviors. The predictive nature of the prototype entitled “Diabetes Onset” was poorly received and removed after the first iteration. The Relative Risk prototype was valued for being straightforward but feared to be boring. The Metabolic Age prototype was anticipated to be more motivating for behavior change, but there were some concerns that the terminology may not be understood by everyone. Conclusions: Participants were divided on which of the 2 prototypes, “Metabolic Age” or “Relative Risk,” they would favor adopting. Further testing is now required to determine which prototype will be more effective in motivating behavior change. This study’s insights on the design process and valued characteristics of a risk communication tool will inform future development of such interventions. %M 39500495 %R 10.2196/50456 %U https://formative.jmir.org/2024/1/e50456 %U https://doi.org/10.2196/50456 %U http://www.ncbi.nlm.nih.gov/pubmed/39500495 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e59873 %T The CHALO! 2.0 mHealth-Based Multilevel Intervention to Promote HIV Testing and Linkage-to-Care Among Men Who Have Sex with Men in Mumbai, India: Protocol for a Randomized Controlled Trial %A Chaudary,Jatin %A Rawat,Shruta %A Dange,Alpana %A Golub,Sarit A %A Kim,Ryung S %A Chakrapani,Venkatesan %A Mayer,Kenneth H %A Arnsten,Julia %A Patel,Viraj V %+ Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine, Montefiore Health System, 111 E 210th Street, Bronx, NY, 10467, United States, 1 718 920 4321, viraj.patel@einsteinmed.edu %K Keywords: digital health %K HIV prevention %K social media %K stigma %K gay %K men who have sex with men %K MSM %D 2024 %7 5.11.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Current programs to engage marginalized populations such as gay and bisexual individuals and other men who have sex with men (MSM) in HIV prevention interventions do not often reach all MSM who may benefit from them. To reduce the global burden of HIV, far-reaching strategies are needed to engage MSM in HIV prevention and treatment. Globally, including low- and middle-income countries, MSM are now widely using internet-based social and mobile technologies (SMTs; eg, dating apps, social media, and WhatsApp [Meta]), which provides an unprecedented opportunity to engage unreached and underserved groups, such as MSM for HIV prevention and care. Objective: This study aimed to assess the effectiveness of a multilevel mobile health (mHealth)–based intervention to improve HIV testing uptake and status neutral linkage-to-care among sexually active MSM reached through internet-based platforms in Mumbai, India. Methods: In this randomized controlled trial, we will determine whether CHALO! 2.0 (a theory-based multilevel intervention delivered in part through WhatsApp) results in increased HIV testing and linkage-to-care (prevention or treatment). This study is being conducted among 1000 sexually active MSM who are unaware of their HIV status (never tested or tested >6 months ago) and are recruited through SMTs in Mumbai, India. We will conduct a 12-week, 3-arm randomized trial comparing CHALO! 2.0 to 2 control conditions—an attention-matched SMT-based control (also including a digital coupon for free HIV testing) and a digital coupon–only control. The primary outcomes will be HIV testing and status neutral linkage-to-care by 6 months post enrollment. Participants will be followed up for a total of 18 months to evaluate the long-term impact. Results: The study was funded in 2020, with recruitment having started in April 2022 due to delays from the COVID-19 pandemic. Baseline survey data collection began in April 2022, with follow-up surveys starting in July 2022. As of April 2022, we enrolled 1004 participants in the study. The completion of follow-up data collection is expected in January 2025, with results to be published thereafter. Conclusions: While global health agencies have called for internet-based interventions to engage populations vulnerable to HIV who are not being reached, few proven effective and scalable models exist and none is in India, which has one of the world’s largest HIV epidemics. This study will address this gap by testing a multicomponent mHealth intervention to reach and engage MSM at high priority for HIV interventions and link them to HIV testing and prevention or treatment. Trial Registration: ClinicalTrials.gov NCT04814654; https://clinicaltrials.gov/study/NCT04814654. Clinical Trial Registry of India CTRI/2021/03/032280 International Registered Report Identifier (IRRID): DERR1-10.2196/59873 %M 39499921 %R 10.2196/59873 %U https://www.researchprotocols.org/2024/1/e59873 %U https://doi.org/10.2196/59873 %U http://www.ncbi.nlm.nih.gov/pubmed/39499921 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e56475 %T Efficacy of a WeChat-Based, Multidisciplinary, Full-Course Nutritional Management Program on the Nutritional Status of Patients With Ovarian Cancer Undergoing Chemotherapy: Randomized Controlled Trial %A Tian,Xiaojuan %A Liu,Yan %A Zhang,Jiahua %A Yang,Lixiao %A Feng,Linyao %A Qi,Aidong %A Liu,Hanjiazi %A Liu,Pengju %A Li,Ying %K WeChat %K nutrition management %K ovarian cancer %K chemotherapy %K mobile health %D 2024 %7 4.11.2024 %9 %J JMIR Mhealth Uhealth %G English %X Background: As the most malignant type of cancer in the female reproductive system, ovarian cancer (OC) has become the second leading cause of death among Chinese women. Chemotherapy is the main treatment for patients with OC, and its numerous adverse effects can easily lead to malnutrition. It is difficult to centrally manage patients with OC in the intervals between chemotherapy. The use of WeChat, an effective mobile tool, in chronic disease management has been highlighted. Objective: This study aimed to implement a continuous follow-up strategy and health monitoring based on the WeChat platform for patients with OC undergoing chemotherapy to ensure that each phase of chemotherapy was delivered on schedule and to improve the survival rate of patients with OC. Methods: Participants were recruited and randomly assigned to either the WeChat-based nutrition intervention group or the usual care group. A self-administered general information questionnaire was used at enrollment to obtain basic information about the patients. The Patient-Generated Subjective Global Assessment (PG-SGA) Scale was used to investigate the nutritional status of the patients at 3 time points (T0=before the first admission to the hospital for chemotherapy, T1=2 weeks after the first chemotherapy, and T6=2 weeks after the sixth chemotherapy). The blood indices of patients were investigated through the inhospital health care system at 3 times(T0=before the first admission to the hospital for chemotherapy, T1=2 weeks after the first chemotherapy, and T6=2 weeks after the sixth chemotherapy). Patients in the intervention group were introduced to the nutrition applet, invited to join the nutrition management group chat, and allowed to consult on nutritional issues in private chats with nutrition management team members. Linear mixed models were used to analyze changes in each nutritional indicator in the 2 groups, with their baseline measurements as covariates; with group, time, and group-time interactions considered as fixed effects; and with patients considered as random effects. Results: A total of 96 patients with OC undergoing chemotherapy were recruited into the study. Distribution was based on a 1:1 ratio, with 48 patients each in the nutrition intervention group and the usual care group. The attrition rate after the first chemotherapy session was 18.75%. The mixed linear model revealed that the group-based effect and the group-time interaction effect on PG-SGA scores were significant (F38,38=4.763, P=.03; F37,37=6.368, P=.01), whereas the time-based effect on PG-SGA scores was not (F38,38=0.377; P=.54). The findings indicated that the group-based effect, the time-based effect, and the group-time interaction effect on nutrition-inflammation composite indices were significant (F38,38=7.653, P=.006; F38,38=13.309, P<.001; F37,37=92.304, P<.001; F37,38=110.675, P<.001; F38,38=10.379, P=.002; and F37,37=5.289, P=.02). Conclusions: This study provided evidence that a WeChat-based, multidisciplinary, full-course nutritional management program can significantly improve the nutritional status of patients with OC during chemotherapy. Trial Registration: ClinicalTrials.gov NCT06379191; https://clinicaltrials.gov/study/NCT06379191 %R 10.2196/56475 %U https://mhealth.jmir.org/2024/1/e56475 %U https://doi.org/10.2196/56475 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e54565 %T User Views on Online Sexual Health Symptom Checker Tool: Qualitative Research %A King,Alicia Jean %A Bilardi,Jade Elissa %A Towns,Janet Mary %A Maddaford,Kate %A Fairley,Christopher Kincaid %A Chow,Eric P F %A Phillips,Tiffany Renee %+ School of Translational Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, 580 Swanston Street, Carlton, Melbourne, 3053, Australia, 61 93416266, aking@mshc.org.au %K sexual health %K sexually transmitted diseases %K risk assessment %K risk factors %K smartphone apps %K help-seeking behavior %K health literacy %K information seeking behavior %D 2024 %7 4.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Delayed diagnosis and treatment of sexually transmitted infections (STIs) contributes to poorer health outcomes and onward transmission to sexual partners. Access to best-practice sexual health care may be limited by barriers such as cost, distance to care providers, sexual stigma, and trust in health care providers. Online assessments of risk offer a novel means of supporting access to evidence-based sexual health information, testing, and treatment by providing more individualized sexual health information based on user inputs. Objective: This developmental evaluation aims to find potential users’ views and experiences in relation to an online assessment of risk, called iSpySTI (Melbourne Sexual Health Center), including the likely impacts of use. Methods: Individuals presenting with urogenital symptoms to a specialist sexual health clinic were given the opportunity to trial a web-based, Bayesian-powered tool that provides a list of 2 to 4 potential causes of their symptoms based on inputs of known STI risk factors and symptoms. Those who tried the tool were invited to participate in a once-off, semistructured research interview. Descriptive, action, and emotion coding informed the comparative analysis of individual cases. Results: Findings from interviews with 14 people who had used the iSpySTI tool support the superiority of the online assessment of STI risk compared to existing sources of sexual health information (eg, internet search engines) in providing trusted and probabilistic information to users. Additionally, potential users reported benefits to their emotional well-being in the intervening period between noticing symptoms and being able to access care. Differences in current and imagined urgency of health care seeking and emotional impacts were found based on clinical diagnosis (eg, non-STI, curable and incurable but treatable STIs) and whether participants were born in Australia or elsewhere. Conclusions: Online assessments of risk provide users experiencing urogenital symptoms with more individualized and evidence-based health information that can improve their health care–seeking and provide reassurance in the period before they can access care. %R 10.2196/54565 %U https://formative.jmir.org/2024/1/e54565 %U https://doi.org/10.2196/54565 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e60165 %T Effectiveness of Computer-Based Psychoeducational Self-Help Platforms for Eating Disorders (With or Without an Associated App): Protocol for a Systematic Review %A Gentile,Alessandra %A Kristian,Yosua Yan %A Cini,Erica %+ Division of Medicine, University College London, Gower St, London, WC1E 6BT, United Kingdom, 44 020 7679 2000, yosua.kristian.23@ucl.ac.uk %K self-help %K online self-help %K eating disorders %K anorexia nervosa %K psychoeducational intervention %K psychoeducation %K binge eating %K anorexia %K bulimia %K access to care %K patient education %K patient self-help %D 2024 %7 4.11.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Access to psychological health care is extremely difficult, especially for individuals with severely stigmatized disorders such as eating disorders (EDs). There has been an increase in children, adolescents, and adults with ED symptoms and ED, especially following the COVID-19 pandemic. Computer-based self-help platforms (± associated apps) allow people to bridge the treatment gap and receive support when in-person treatment is unavailable or not preferred. Objective: The aim of this systematic review is to evaluate the effectiveness of computer-based self-help platforms for EDs, some of which may have associated apps. Methods: The proposed systematic review will follow the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. This review will report and evaluate the literature concerning the efficacy of self-help platforms for EDs. Articles were obtained from the Ovid MEDLINE, Embase, Global Health, and APA PsycInfo. The inclusion criteria included research with original data and gray literature; research evaluating the efficacy of web-based psychoeducational self-help platforms for EDs; people with an ED diagnosis, ED symptoms, at risk of developing EDs, or from the general population without ED-related behaviors; pre– and post–computer-based ± associated apps intervention clinical outcome of ED symptoms; pre– and post–computer-based ± associated apps intervention associated mental health difficulties; and literature in English. The exclusion criteria were solely guided self-help platforms, only in-person interventions with no computer-based ± associated apps comparison group, only in-person–delivered CBT, self-help platforms for conditions other than eating disorders, systematic reviews, meta-analyses, posters, leaflets, books, reviews, and research that only reported physical outcomes. Two independent authors used the search terms to conduct the initial search. The collated articles then were screened by their titles and abstracts, and finally, full-text screenings were conducted. The Cochrane Risk of Bias 2 tool will be used to assess the risks of bias in the included studies. Data extraction will be conducted, included studies will undergo narrative synthesis, and results will be presented in tables. The systematic review will be submitted to a peer-reviewed journal. Results: The authors conducted a database search for articles published by May 31, 2024. In total, 14 studies were included in the systematic review. Data charting, synthesis, and analysis were completed in Microsoft Excel by the end of July 2024. Results will be grouped based on the intervention stages. The results are expected to be published by the end of 2024. Overall, the systematic review found that computer-based self-help platforms are effective in reducing global ED psychopathology and ED-related behaviors. Conclusions: Self-help platforms are helpful first-stage resource in a tiered health care system. Trial Registration: PROSPERO CRD42024520866; https://tinyurl.com/5ys2unsw International Registered Report Identifier (IRRID): DERR1-10.2196/60165 %M 39495557 %R 10.2196/60165 %U https://www.researchprotocols.org/2024/1/e60165 %U https://doi.org/10.2196/60165 %U http://www.ncbi.nlm.nih.gov/pubmed/39495557 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e52557 %T Feasibility of Sexual Health and Contraceptive Web Services for Adolescents and Young Adults: Retrospective Study of a Pilot Program on Reunion Island %A Reynaud,Danielle %A Bouscaren,Nicolas %A Cartron,Emmanuelle %A Marimoutou,Catherine %K sexual health %K adolescent %K young adults %K web application %K contraception prescription %K contraception %K teleconsultation %K telemedicine %K youth %K usage %K e-consultation %K web based %D 2024 %7 1.11.2024 %9 %J JMIR Pediatr Parent %G English %X Background: Sexual health indicators for adolescents and young adults (AYAs) aged between 13 and 25 years are particularly poor on Reunion Island. Access to accurate information as well as sexual health and contraceptive services are vital to maintaining sexual well-being. Teleconsultations offer a promising approach to addressing the sexual health and contraceptive needs of AYAs who are more susceptible to engaging in unprotected sexual intercourse. However, the literature on digital sexual health services for this demographic group is limited. Objective: This study aims to describe the feasibility of a pilot sexual health and contraceptive teleconsultation web service used by AYAs on Reunion Island. Methods: A descriptive, retrospective study was conducted at the Reunion Island University Hospital Center using a convenient sample. Eligible participants were informed about the program through various communication channels, including seminars for health care professionals, radio broadcasts, posters, flyers, press articles, videos, and social media posts. AYAs accessed a web-based platform named SEXTUOZE from December 15, 2021, to September 30, 2022, that offered sexual health information and teleconsultations. Data collected included participant and teleconsultation characteristics, patient satisfaction, and the quality of completeness of medical records. Results: A total of 22 teleconsultations were scheduled and 7 were completed, all via synchronous video communication (duration: median 35 min). Overall, 4731 sessions were generated on the SEXTUOZE website. Reasons cited for accessing the web services were to seek sexual health advice (8/22, 36%), receive an initial birth control prescription (12/22, 55%), and inquire about condom prescriptions (2/22, 9%). Conclusions: While teleconsultation use for sexual health was initially low, it rose toward the end of the study period. Considering all elements of the implementation theory, future research should design interventions that not only are more operative and tailored but also ensure their adoption and sustainability in various health contexts. %R 10.2196/52557 %U https://pediatrics.jmir.org/2024/1/e52557 %U https://doi.org/10.2196/52557 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e52729 %T Understanding Users’ Engagement in a Provider-Created Mobile App for Training to Advance Hepatitis C Care: Knowledge Assessment Survey Study %A Wegener,Maximilian %A Sims,Katarzyna %A Brooks,Ralph %A Nichols,Lisa %A Sideleau,Robert %A McKay,Sharen %A Villanueva,Merceditas %+ Department of Internal Medicine, Section of Infectious Diseases, Yale School of Medicine, Yale University, 135 College Street, Suite 323, New Haven, CT, 06510, United States, 1 2037857026, maximilian.wegener@yale.edu %K HIV %K HCV %K hepatitis C virus %K interactive digital interventions (IDI) %K education %K mobile application %K user engagement %K training %K awareness %K treatment %K testing %D 2024 %7 1.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: The World Health Organization and the Centers for Disease Control and Prevention have set ambitious hepatitis C virus (HCV) elimination targets for 2030. Current estimates show that the United States is not on pace to meet elimination targets due to multiple patient, clinic, institutional, and societal level barriers that contribute to HCV testing and treatment gaps. Among these barriers are unawareness of testing and treatment needs, misinformation concerning adverse treatment reactions, need for substance use sobriety, and treatment efficacy. Strategies to improve viral hepatitis education are needed. Objective: We aim to provide a high-quality HCV educational app for patients and health care workers, particularly nonprescriber staff. The app was vetted by health care providers and designed to guide users through the HCV testing and treatment stages in a self-exploratory way to promote engagement and knowledge retention. The app is comprised of five learning modules: (1) Testing for Hep C (hepatitis C), (2) Tests for Hep C Positive Patients, (3) Treatments Available to You, (4) What to Expect During Treatment, and (5) What to Expect After Treatment. Methods: An HCV knowledge assessment survey was administered to providers and patients at the Yale School of Medicine and 11 Connecticut HIV clinics as part of a grant-funded activity. The survey findings and pilot testing feedback guided the app’s design and content development. Data on app usage from November 2019 to November 2022 were analyzed, focusing on user demographics, engagement metrics, and module usage patterns. Results: There were 561 app users; 216 (38.5%) accessed the training modules of which 151 (69.9%) used the app for up to 60 minutes. Of them, 65 (30.1%) users used it for >60 minutes with a median time spent of 5 (IQR 2-8) minutes; the median time between initial accession and last use was 39 (IQR 18-60) days. Users accessed one or more modules and followed a nonsequential pattern of use: module 1: 163 (75.4%) users; module 4: 82 (38%); module 5: 67 (31%); module 3: 49 (22.7%); module 2: 41 (19%). Conclusions: This app, created in an academic setting, is one of a few available in English and Spanish that provides content-vetted HCV education for patients and health care supportive staff. It offers the convenience of on-demand education, allowing users to access crucial information about HCV management and treatment in a self-directed fashion that acknowledges and promotes variable preferences in learning approaches. While app uptake was relatively limited, we propose that future efforts should focus on combined promotion efforts with marketing strategies experts aligned with academic experts. Incorporating ongoing user feedback and integrating personalized reminders and quizzes, will further enhance engagement, supporting the broader public health HCV elimination goals. %M 39486023 %R 10.2196/52729 %U https://formative.jmir.org/2024/1/e52729 %U https://doi.org/10.2196/52729 %U http://www.ncbi.nlm.nih.gov/pubmed/39486023 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e53744 %T Web-Based Intervention (SunnysideFlex) to Promote Resilience to Posttraumatic Stress Disorder Symptoms During Pregnancy: Development and Pilot Study %A Paltell,Katherine C %A Duffecy,Jennifer %A Maki,Pauline M %A Edalatian Zakeri,Shiva %A Vujanovic,Anka A %A Berenz,Erin C %+ Department of Psychology, University of Illinois at Chicago, 1007 W Harrison St, M/C 285, Chicago, IL, 60607, United States, 1 312 315 0808, kpaltell@uic.edu %K trauma %K posttraumatic stress disorder %K pregnancy %K perinatal %K web-based intervention %K stress %K postpartum %K depression %K child health %K treatment %K behavioral therapy %K SunnysideFlex %D 2024 %7 1.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Approximately 4% to 8% of pregnant individuals meet the criteria for current posttraumatic stress disorder (PTSD), a known risk factor for a multitude of adverse maternal and child health outcomes. However, PTSD is rarely detected or treated in obstetric settings. Moreover, available prenatal PTSD treatments require in-person services that are often inaccessible due to barriers to care. Thus, web-based interventions offer great potential in extending PTSD treatment to high-risk pregnant individuals by providing affordable, accessible care. However, there are currently no web-based interventions designed specifically for the treatment of PTSD symptoms during pregnancy. Objective: This study aims to develop and pilot a 6-week, web-based, cognitive behavioral therapy intervention for PTSD, SunnysideFlex, in a sample of 10 pregnant women with current probable PTSD. Consistent with established guidelines for developing and testing novel interventions, the focus of this pilot study was to evaluate the initial feasibility and acceptability of the SunnysideFlex intervention and preintervention to postintervention changes in PTSD and depression symptoms. This approach will allow for early refinement and optimization of the SunnysideFlex intervention to increase the odds of success in a larger-scale clinical trial. Methods: The SunnysideFlex intervention adapted an existing web-based platform for postpartum depression, Sunnyside for Moms, to include revised, trauma-focused content. A total of 10 pregnant women in weeks 16 to 28 of their pregnancy who reported lifetime interpersonal trauma exposure (ie, sexual or physical assault) and with current probable PTSD (scores ≥33 per the PTSD checklist for DSM-5) were enrolled in the SunnysideFlex intervention. Assessments took place at baseline and 6 weeks (postintervention). Results: All participants were retained through the postintervention assessment period. Engagement was high; participants on average accessed 90% of their lessons, logged on to the platform at least weekly, and reported a generally positive user experience. Moreover, 80% (8/10) of participants demonstrated clinically meaningful reductions in PTSD symptoms from baseline to postintervention, and 50% (5/10) of participants no longer screened positive for probable PTSD at postintervention. Most (6/10, 60%) of the participants maintained subclinical depression symptoms from baseline to postintervention. Conclusions: Findings from this small pilot study indicate that SunnysideFlex may be a feasible and acceptable mechanism for delivering PTSD intervention to high-risk, trauma-exposed pregnant women who might otherwise not have opportunities for services. Larger-scale trials of the intervention are necessary to better understand the impact of SunnysideFlex on PTSD symptoms during pregnancy and the postpartum period. %M 39485381 %R 10.2196/53744 %U https://formative.jmir.org/2024/1/e53744 %U https://doi.org/10.2196/53744 %U http://www.ncbi.nlm.nih.gov/pubmed/39485381 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e54171 %T Assessment of Acceptability, Usage, and Impact on Caregivers of Children With Autism’s Stress and Mindfulness: Multiple-Method Feasibility Study of the 5Minutes4Myself App’s Mindfulness Module %A Larson,Elizabeth %A Mattie,Rebecca L %A Riffkin,Sophia A %K autism %K caregiver %K activities %K mindfulness %K mobile application %K stress %K wellness %K app %K application %K usage %K children %K developmental disability %K usability %K acceptability %K meditation %K wellness application %D 2024 %7 31.10.2024 %9 %J JMIR Hum Factors %G English %X Background: Caregiver wellness programs need to be easily accessible to address caregivers’ constraints to participation. Objective: We aimed to assess the feasibility of 5Minutes4Myself app’s mindfulness module (usability, usage, and impact on caregivers’ levels of mindfulness and perceived stress). Methods: Before and after participation in the 5Minutes4Myself program, 15 participants were asked to complete the Perceived Stress Scale (PSS) and Five Facet Mindfulness Questionnaire (FFMQ). Data on the usage of app-delivered meditations were collected electronically via the app, and app usability was rated on the Modified System Usability Scale. Analyses assessed participants’ frequency of use of app-delivered meditations, app usability, and changes in participants’ stress and mindfulness post intervention. Results: Overall, participants completed 10.9 minutes of mindfulness meditations per week and rated the app 76.7, indicating above-average usability. Related samples t tests (2-tailed) found that group PSS (t10=1.20, P=.26) and FFMQ (t10=−1.57, P=.15) pre- or postintervention mean scores were not significantly different. However, a visualization of pre- and post-PSS and mindfulness scores suggested there was a group of responders who had decreased stress with increased mindfulness. This was confirmed via an individual change analysis. The effect size of the FFMQ scores (d=0.47) suggests there may be treatment effects with a larger sample. A hierarchical multiple regression analysis examined the degree mindfulness impacted perceived stress; 20% of the variance in participants’ perceived stress could be attributed to increases in self-rated mindfulness (P=.04) when controlling for preintervention stress levels. Conclusions: Caregivers found the app highly usable and on average used low-dose levels of mindfulness meditations (10 min/wk). For responders, increased mindfulness was related to stress reduction to population-based levels. Trial Registration: ClinicalTrials.gov NCT03771001; https://clinicaltrials.gov/study/NCT03771001 %R 10.2196/54171 %U https://humanfactors.jmir.org/2024/1/e54171 %U https://doi.org/10.2196/54171 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e59142 %T Effectiveness of King’s Theory of Goal Attainment in Blood Glucose Management for Newly Diagnosed Patients With Type 2 Diabetes: Randomized Controlled Trial %A Yan,Man %A Yu,Yingchun %A Li,Shuping %A Zhang,Peiling %A Yu,Jiaxiang %+ Department of Nursing and Rehabilitations, Faculty of Medicine and Health Sciences, University Putra Malaysia, Administrative building, 3rd Fl., Serdang, 43400, Malaysia, 60 0178736091, yuge1185@gmail.com %K King’s Theory of Goal Attainment %K online feedback approach %K newly diagnosed patients with type 2 diabetes mellitus %K blood glucose control %K type 2 diabetes %K diabetes mellitus %K blood glucose %D 2024 %7 31.10.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Diabetes poses a significant public health challenge in China and globally, with the number of patients expected to reach 592 million by 2035, notably in Asia. In China alone, an estimated 140 million individuals are living with diabetes, and a significant portion is nonadherent to medications, underscoring the urgency of effective management strategies. Recognizing the necessity of early and comprehensive management for newly diagnosed patients with type 2 diabetes, this study leverages an online teach-back method and “Internet + Nursing” platform based on King’s Theory of Goal Attainment. The approach aims to enhance glycemic control and reduce fear and misconceptions about the disease, addressing both the educational and emotional needs of the patients. Objective: The primary aim of this study was to assess the effectiveness of King’s Goal Attainment Theory in the management of newly diagnosed patients with type 2 diabetes. This research sought to develop a collaborative model for blood glucose management, integrating the expertise and roles of physicians, nurses, and patients. The model is designed to enhance the synergy in health care provision, ensuring a comprehensive approach to diabetes management. Methods: In this study conducted at Changzhou Traditional Chinese Medicine Hospital between January 2022 and February 2023, eligible patients were randomized into a control group or an online feedback group. The control group received standard care, while the online feedback group participated in a King’s Theory of Goal Attainment–based online teach-back program, enhanced by “Internet + Nursing” strategies. This included an interactive platform for goal planning, video content sharing, comprehension assessment, misconception correction, and patient-driven recaps of disease information. Health monitoring was facilitated through the “Internet + Nursing” platform. The study focused on comparing changes in glucose metabolism and emotional disorder symptoms between the groups to evaluate the intervention’s effectiveness. Results: Following a 24-week intervention, we observed significant differences in key metrics between the online feedback group and the control group, each comprising 60 participants. The online feedback group demonstrated significant reductions in fasting plasma glucose, 2-hour postprandial glucose, and hemoglobin A1c (P<.05). Additionally, there was a notable decrease in hypoglycemia-related anxiety and alexithymia within this group. Conversely, the control group maintained relatively higher values for these metrics at the same time point (P<.05). These findings underscore the efficacy of online feedback in managing glycemic control and reducing psychological distress associated with hypoglycemia. Conclusions: The online teaching-back method, guided by King’s Theory of Goal Attainment, effectively enhances glycemic control, reducing fasting plasma glucose, 2-hour postprandial glucose, and hemoglobin A1c levels in newly diagnosed patients with type 2 diabetes. Simultaneously, it alleviates hypoglycemia-related anxiety and mitigates alexithymia. This approach merits widespread promotion and implementation in clinical settings. Trial Registration: Chinese Clinical Trial Registry ChiCTR2400079547; https://www.chictr.org.cn/showproj.html?proj=208223 %M 39481094 %R 10.2196/59142 %U https://www.jmir.org/2024/1/e59142 %U https://doi.org/10.2196/59142 %U http://www.ncbi.nlm.nih.gov/pubmed/39481094 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e58591 %T Effects of HIV Self-Testing on Testing Promotion and Risk Behavior Reduction Among Transgender Women in China: Randomized Controlled Trial %A Zhu,Yan-Yan %A Ye,Ze-Hao %A Chu,Zhen-Xing %A Liu,Yingjie %A Wei,Jie %A Jia,Le %A Jiang,Yong-Jun %A Shang,Hong %A Hu,Qing-Hai %+ State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, NHC Key Laboratory of AIDS Prevention and Treatment, National Clinical Research Center for Laboratory Medicine, The First Hospital of China Medical University, China Medical University, 155 Nanjing North Street, Heping District, Shenyang, 110001, China, 86 024 83282192, qhhu@cmu.edu.cn %K HIV %K HIV self-testing %K testing behavior %K sexual behaviours %K transgender women %K sexual health %K mobile phone %D 2024 %7 29.10.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: To date, no randomized controlled trials have specifically addressed behavior changes after HIV self-testing (HIVST) among transgender women. Objective: This study aims to evaluate the effects of HIVST on changes in HIV testing behavior, frequency of condomless sex, and partner numbers among transgender women in China. Methods: Participants were recruited from 2 Chinese cities using both online and offline methods. Transgender women were randomly assigned to receive an HIVST intervention. Data from the previous 3 months were collected at baseline, 3 months, and 6 months. The primary outcome was the mean change in the number of HIV tests among transgender women during the 6-month follow-up. An intention-to-treat analysis was conducted. The statistical analysis used analysis of covariance and linear mixed-effects models. Results: From February to June 2021, and 255 transgender women were recruited, of which only 36.5% (93/255) had a steady job, and 27.1% (69/255) earned less than US $414.9 of income per month. They were randomly assigned to the intervention (n=127) and control (n=128) groups. At 6 months, the mean number of HIV tests was 2.14 (95% CI 1.80-2.48) in the intervention group and 1.19 (95% CI 0.99-1.40) in the control group (P<.001), with increases of 0.84 (95% CI 0.54-1.14) and 0.11 (95% CI –0.19-0.41) over 6 months, respectively. The net increase was 0.73 (95% CI 0.31-1.15; P<.001), with a similar adjusted result. No significant differences in the frequency of condomless sex or partner numbers were observed between the 2 groups. Conclusions: HIVST is an effective strategy for enhancing regular HIV testing behavior among transgender women in China. This strategy should be combined with measures to address the financial vulnerability of the transgender women community to reduce subsequent risk behaviors, including condomless sex. Trial Registration: Chinese Clinical Trial Registry ChiCTR2000039766; https://www.chictr.org.cn/showproj.html?proj=61402 %M 39471367 %R 10.2196/58591 %U https://www.jmir.org/2024/1/e58591 %U https://doi.org/10.2196/58591 %U http://www.ncbi.nlm.nih.gov/pubmed/39471367 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e59016 %T Development of the Happy Hands Self-Management App for People with Hand Osteoarthritis: Feasibility Study %A Tveter,Anne Therese %A Varsi,Cecilie %A Maarnes,Marit Kristin %A Pedersen,Stein Jarle %A Christensen,Barbara S %A Blanck,Thale Beate %A Nyheim,Sissel B %A Pelle,Tim %A Kjeken,Ingvild %+ Health Service Research and Innovation Unit, Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Diakonveien 12, Oslo, 0319, Norway, 47 22451500, a.t.tveter@medisin.uio.no %K Osteoarthritis %K hand exercises %K home exercise %K first-line treatment %K mHealth %K eHealth %K self-management %K app development %K design %K usefulness %K satisfaction %K activity performance %K social cognitive theory %K behavior change %D 2024 %7 29.10.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Patient education, hand exercises, and the use of assistive devices are recommended as first-line treatments for individuals with hand osteoarthritis (OA). However, the quality of care services for this patient group is suboptimal in primary care. Objective: The overarching goal was to develop and evaluate feasibility of an app-based self-management intervention for people with hand OA. This feasibility study aims to assess self-reported usability and satisfaction, change in outcomes and quality-of-care, exercise adherence and patients’ experiences using the app. Methods: The development and feasibility testing followed the first 2 phases of the Medical Research Council framework for the development and evaluation of complex interventions and were conducted in close collaboration with patient research partners (PRPs). A 3-month pre-post mixed methods design was used to evaluate feasibility. Men and women over 40 years of age diagnosed with painful, symptomatic hand OA were recruited. Usability was assessed using the System Usability Scale (0-100), while satisfaction, usefulness, pain, and stiffness were evaluated using a numeric rating scale (NRS score from 0 to 10). The activity performance of the hand was measured using the Measure of Activity Performance of the Hand (MAP-Hand) (1-4), grip strength was assessed with a Jamar dynamometer (kg), and self-reported quality of care was evaluated using the Osteoarthritis Quality Indicator questionnaire (0-100). Participants were deemed adherent if they completed at least 2 exercise sessions per week for a minimum of 8 weeks. Focus groups were conducted to explore participants’ experiences using the app. Changes were analyzed using a paired sample t test (mean change and 95% CI), with the significance level set at P<.05. Results: The first version of the Happy Hands app was developed based on the needs and requirements of the PRPs, evidence-based treatment recommendations, and the experiences of individuals living with hand OA. The app was designed to guide participants through a series of informational videos, exercise videos, questionnaires, quizzes, and customized feedback over a 3-month period. The feasibility study included 71 participants (mean age 64 years, SD 8; n=61, 86%, women), of whom 57 (80%) completed the assessment after 3 months. Usability (mean 91.5 points, SD 9.2 points), usefulness (median 8, IQR 7-10), and satisfaction (median 8, IQR 7-10) were high. Significant improvements were observed in self-reported quality of care (36.4 points, 95% CI 29.7-43.1, P<.001), grip strength (right: 2.9 kg, 95% CI 1.7-4.1; left: 3.2 kg, 95% CI 1.9-4.6, P<.001), activity performance (0.18 points, 95% CI 0.11-0.25, P<.001), pain (1.7 points, 95% CI 1.2-2.2, P<.001), and stiffness (1.9 points, 95% CI 1.3-2.4, P=.001) after 3 months. Of the 71 participants, 53 (75%) were adherent to the exercise program. The focus groups supported these results and led to the implementation of several enhancements in the second version of the app. Conclusions: The app-based self-management intervention was deemed highly usable and useful by patients. The results further indicated that the intervention may improve quality of care, grip strength, activity performance, pain, and stiffness. However, definitive conclusions need to be confirmed in a powered randomized controlled trial. Trial Registration: NCT05150171 %M 39470716 %R 10.2196/59016 %U https://formative.jmir.org/2024/1/e59016 %U https://doi.org/10.2196/59016 %U http://www.ncbi.nlm.nih.gov/pubmed/39470716 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e47104 %T Mobile-Based Platform With a Low-Calorie Dietary Intervention Involving Prepackaged Food for Weight Loss for People With Overweight and Obesity in China: Half-Year Follow-Up Results of a Randomized Controlled Trial %A Wang,Xi %A Wang,Suyuan %A Zhong,Lingyu %A Zhang,Chenghui %A Guo,Yanhong %A Li,Mingxia %A Zhao,Li %A Ji,Shuming %A Pan,Junjie %A Wu,Yunhong %K weight loss %K obesity %K body fat %K food replacement product %K meal replacement %K weight %K obese %K RCT %K randomized %K mHealth %K mobile health %K mobile app %K mobile application %K mobile phone %D 2024 %7 28.10.2024 %9 %J JMIR Mhealth Uhealth %G English %X Background: Obesity is a rapidly increasing health problem in China, causing massive economic and health losses annually. Many techniques have emerged to help people with obesity better adhere to intervention programs and achieve their weight loss goals, including food replacement and internet-delivered weight loss consultations. Most studies on weight loss interventions mainly focused on the change in body weight or BMI; however, body fat, especially visceral fat mass, is considered the main pathogenic factor in obesity. In China, more reliable evidence is required on this topic. Moreover, it is unclear whether an integrated weight loss program combining food replacement products, mobile app-based platforms, and daily body composition monitoring using a wireless scale is useful and practical in China. Objective: In this 2-arm, parallel-designed, randomized study, we explored the effectiveness and safety of the Metawell (Weijian Technologies Inc) weight loss program in China, which combines prepackaged biscuits, a wireless scale, and a mobile app. Methods: Participants in the intervention group were guided to use food replacement products and a scale for weight loss and monitoring, whereas participants in the control group received printed material with a sample diet and face-to-face education on weight loss at enrollment. The intervention lasted for 3 months, and follow-up visits were conducted at months 3 and 6 after enrollment. Dual-energy x-ray absorptiometry and quantitative computed tomography were used to assess body fat. A multilevel model for repeated measurements was used to compare differences between the 2 groups. Results: In total, 220 patients were randomly assigned to intervention (n=110) and control (n=110) groups. Participants in the intervention group had significantly greater decreases in BMI, total body fat, visceral adipose area, and subcutaneous adipose area (all P<.001) than those in the control group. However, the rate of change in lean mass was not significantly different between the 2 groups (P=.62). Further, 35 participants in the intervention group reported adverse events. Constipation was the most frequently reported adverse event (11/110), followed by dizziness (6/110), hypoglycemia (4/110), fatigue (3/110), and gastritis (3/35). Conclusions: The Metawell program was effective for weight loss. After the intervention, participants in the intervention group lost more body weight and body fat while retaining muscle mass than those in the control group. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900021630; https://www.chictr.org.cn/showproj.html?proj=36183 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2020-048106 %R 10.2196/47104 %U https://mhealth.jmir.org/2024/1/e47104 %U https://doi.org/10.2196/47104 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e57376 %T Outcomes of a Comprehensive Mobile Vaping Cessation Program in Adults Who Vape Daily: Cohort Study %A Marler,Jennifer D %A Fujii,Craig A %A Utley,MacKenzie T %A Balbierz,Daniel J %A Galanko,Joseph A %A Utley,David S %+ Pivot Health Technologies, Inc, 1010 Commercial St, Suite C, San Carlos, CA, 94070, United States, 1 4082145545, marler@pivot.co %K app %K digital health %K mobile health %K mHealth %K mobile apps %K smartphone %K vaping %K vaping cessation %K mobile phone %D 2024 %7 28.10.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: In the United States, e-cigarettes, or vapes, are the second most commonly used tobacco product. Despite abundant smartphone app–based cigarette cessation programs, there are few such programs for vaping and even fewer supporting data. Objective: This exploratory, prospective, single-arm, remote cohort study of the Pivot vaping cessation program assessed enrollment and questionnaire completion rates, participant engagement and retention, changes in attitudes toward quitting vaping, changes in vaping behavior, and participant feedback. We aimed to establish early data to inform program improvements and future study design. Methods: American adults aged ≥21 years who vaped daily, reported ≥5 vape sessions per day, and planned to quit vaping within 6 months were recruited on the web. Data were self-reported via app- and web-based questionnaires. Outcomes included engagement and retention (ie, weeks in the program, number of Pivot app openings, and number of messages sent to the coach), vaping attitudes (ie, success in quitting and difficulty staying quit), vaping behavior (ie, quit attempts, Penn State Electronic Cigarette Dependence Index, 7- and 30-day point-prevalence abstinence [PPA], and continuous abstinence [defined as ≥7-day PPA at 12 weeks+30-day PPA at 26 weeks+0 vaping sessions since 12 weeks]), and participant feedback. Results: In total, 73 participants onboarded (intention-to-treat sample); 68 (93%) completed the 12- and 26-week questionnaires (completer samples). On average, participants were active in Pivot for 13.8 (SD 7.3) weeks, had 87.3 (SD 99.9) app sessions, and sent 37.6 (SD 42.3) messages to their coach over 26 weeks. Mean success in quitting and difficulty staying quit (scale of 1-10) improved from baseline to 12 weeks—4.9 (SD 2.9) to 7.0 (SD 3.0) and 4.0 (SD 2.8) to 6.2 (SD 3.1), respectively (P<.001 in both cases). Most participants (64/73, 88%) made ≥1 quit attempt. At 26 weeks, intention-to-treat 7-day PPA, 30-day PPA, and continuous abstinence rates were 48% (35/73), 45% (33/73), and 30% (22/73), respectively. In total, 45% (33/73) of the participants did not achieve 7-day PPA at 26 weeks; their mean Penn State Electronic Cigarette Dependence Index score decreased from baseline (13.9, SD 3.1) to 26 weeks (10.8, SD 4.5; mean change –3.2, SD 3.9; P<.001); 48% (16/33) of these participants improved in the e-cigarette dependence category. At 2 weeks, 72% (51/71) of respondents reported that using Pivot increased their motivation to quit vaping; at 4 weeks, 79% (55/70) reported using Pivot decreased the amount they vaped per day. Conclusions: In this first evaluation of Pivot in adult daily vapers, questionnaire completion rates were >90%, average program engagement duration was approximately 14 weeks, and most participants reported increased motivation to quit vaping. These and early cessation outcomes herein suggest a role for Pivot in vaping cessation and will inform associated future study and program improvements. %M 39331522 %R 10.2196/57376 %U https://formative.jmir.org/2024/1/e57376 %U https://doi.org/10.2196/57376 %U http://www.ncbi.nlm.nih.gov/pubmed/39331522 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e52609 %T Acceptability of Digital Mental Health Interventions for Depression and Anxiety: Systematic Review %A Lau,Carrie K Y %A Saad,Anthony %A Camara,Bettina %A Rahman,Dia %A Bolea-Alamanac,Blanca %+ Department of Psychiatry, Women's College Hospital, 76 Grenville St, Toronto, ON, M5S 1B2, Canada, 1 647 331 2707, Blanca.BoleaAlamanac@wchospital.ca %K acceptability %K mental health %K depression %K anxiety %K mobile app %K internet %K mobile phone %K mobile health %K mHealth %K digital health %D 2024 %7 28.10.2024 %9 Review %J J Med Internet Res %G English %X Background: Depression and anxiety disorders are common, and treatment often includes psychological interventions. Digital health interventions, delivered through technologies such as web-based programs and mobile apps, are increasingly used in mental health treatment. Acceptability, the extent to which an intervention is viewed positively, has been identified as contributing to patient adherence and engagement with digital health interventions. Acceptability, therefore, impacts the benefit derived from using digital health interventions in treatment. Understanding the acceptability of digital mental health interventions among patients with depression or anxiety disorders is essential to maximize the effectiveness of their treatment. Objective: This review investigated the acceptability of technology-based interventions among patients with depression or anxiety disorders. Methods: A systematic review was performed based on PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and PROSPERO (International Prospective Register of Systematic Reviews) guidelines. We searched PubMed, Web of Science, and Ovid in May 2022. Studies were included if they evaluated digital interventions for the treatment of depression or anxiety disorders and investigated their acceptability among adult patients. Studies were excluded if they targeted only specific populations (eg, those with specific physical health conditions), investigated acceptability in healthy individuals or patients under the age of 18 years, involved no direct interaction between patients and technologies, used technology only as a platform for traditional care (eg, videoconferencing), had patients using technologies only in clinical or laboratory settings, or involved virtual reality technologies. Acceptability outcome data were narratively synthesized by the direction of acceptability using vote counting. Included studies were evaluated using levels of evidence from the Oxford Centre for Evidence-Based Medicine. The risk of bias was assessed using a tool designed for this review and GRADE (Grading of Recommendations, Assessment, Development, and Evaluation). Results: A total of 143 articles met the inclusion criteria, comprising 67 (47%) articles on interventions for depression, 65 (45%) articles on interventions for anxiety disorders, and 11 (8%) articles on interventions for both. Overall, 90 (63%) were randomized controlled trials, 50 (35%) were other quantitative studies, and 3 (2%) were qualitative studies. Interventions used web-based programs, mobile apps, and computer programs. Cognitive behavioral therapy was the basis of 71% (102/143) of the interventions. Digital mental health interventions were generally acceptable among patients with depression or anxiety disorders, with 88% (126/143) indicating positive acceptability, 8% (11/143) mixed results, and 4% (6/143) insufficient information to categorize the direction of acceptability. The available research evidence was of moderate quality. Conclusions: Digital mental health interventions seem to be acceptable to patients with depression or anxiety disorders. Consistent use of validated measures for acceptability would enhance the quality of evidence. Careful design of acceptability as an evaluation outcome can further improve the quality of evidence and reduce the risk of bias. Trial Registration: Open Science Framework Y7MJ4; https://doi.org/10.17605/OSF.IO/SPR8M %M 39466300 %R 10.2196/52609 %U https://www.jmir.org/2024/1/e52609 %U https://doi.org/10.2196/52609 %U http://www.ncbi.nlm.nih.gov/pubmed/39466300 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e52295 %T Mobile App–Assisted Parent Training Intervention for Behavioral Problems in Children With Autism Spectrum Disorder: Pilot Randomized Controlled Trial %A Lee,JooHyun %A Lim,JaeHyun %A Kang,Soyeon %A Kim,Sujin %A Jung,So Yoon %A Kim,Sujin %A Hong,Soon-Beom %A Park,Yu Rang %+ Department of Biomedical Systems Informatics, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea, 82 0222282493, yurangpark@yuhs.ac %K autism spectrum disorder %K parent training program %K parent education %K behavioral problems %K child behavior %K mobile app %K feasibility %K mHealth %K evidence-based parent training %D 2024 %7 28.10.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: In children with autism spectrum disorder (ASD), problem behaviors play a dysfunctional role, causing as much difficulty with daily living and adjustment as the core symptoms. If such behaviors are not effectively addressed, they can result in physical, economic, and psychological issues not only for the individual but also for family members. Objective: We aimed to develop and evaluate the feasibility of a mobile app–assisted parent training program for reducing problem behaviors in children with ASD. Methods: This open-label, single-center, randomized controlled trial was conducted among parents of children with ASD aged 36-84 months. Participants were recruited from the Department of Psychiatry at Seoul National University Hospital. Participants were randomly assigned (1:1) by a blinded researcher. Randomization was performed using a stratified block randomization (with a block size of 4). Parents in the intervention group completed the mobile app–assisted parent training program at home over a 12-week period. They continued to receive their usual nondrug treatment in addition to the mobile app–assisted parent training program. The control group continued to receive their usual nonpharmaceutical treatment for 12 weeks without receiving the parent training program intervention. The primary outcome measure was the median change in the Korean Child Behavior Checklist (K-CBCL) scores from before to after the intervention. Lower scores on the K-CBCL indicated a decrease in overall problem behavior. Results: Between November 9, 2022, and December 8, 2022, 64 participants were enrolled. Overall, 42 children (intervention group median age: 49, IQR 41-52.5 months; control group median age: 49, IQR 42-58 months) of the participants joined the program. The intervention group included 20 (48%) participants and the control group included 22 (52%) participants. In the intervention group, the K-CBCL total scores showed a decrease after the intervention, with a median difference of –0.5 (95% CI –4.5 to 3). Pervasive developmental disorder scores also showed a decrease, with a median difference of –2.1 (95% CI –8.5 to 2.5). However, there was no significant difference in Clinical Global Impression–Severity of Illness scores after the intervention for both the control and intervention groups. Scores on the Korean version of the Social Communication Questionnaire showed a further decrease after the intervention in the intervention group (median difference –2, 95% CI –4 to 1). Caregivers’ stress evaluated using the Korean Parenting Stress Index Fourth Edition–Short Form did not show any significant differences between the control and intervention groups. There were no adverse events related to study participation. Conclusions: The findings demonstrated the feasibility of using mobile devices for evidence-based parent training to reduce problem behaviors in children with ASD. Mobile devices’ accessibility and flexibility may provide a viable alternative for offering early intervention for problem behaviors in children with ASD. Trial Registration: CRIS KCT0007841; https://cris.nih.go.kr/cris/search/detailSearch.do?&seq=23112 %M 39466295 %R 10.2196/52295 %U https://humanfactors.jmir.org/2024/1/e52295 %U https://doi.org/10.2196/52295 %U http://www.ncbi.nlm.nih.gov/pubmed/39466295 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e64454 %T Client Perspectives of Case Stories in Internet-Delivered Cognitive Behavioral Therapy for Public Safety Personnel: Mixed Methods Study %A Price,Jill AB %A Gregory,Julia %A McCall,Hugh C %A Landry,Caeleigh A %A Beahm,Janine D %A Hadjistavropoulos,Heather D %+ Canadian Institute for Public Safety Research and Treatment, University of Regina, 3737 Wascana Parkway, Regina, SK, S4S0A2, Canada, 1 3063378418, jill.price@uregina.ca %K internet-delivered cognitive behavioral therapy %K case stories %K public safety personnel %K public safety %K mental health %K internet interventions %K digital mental health interventions %K first responders %D 2024 %7 25.10.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Internet-delivered cognitive behavioral therapy (ICBT) is an effective and convenient means of offering cognitive behavioral therapy to the general population. To increase access to ICBT among Canadian public safety personnel (PSP)—a group that experiences elevated rates of mental health concerns and barriers to mental health care—a clinical research unit called PSPNET has tailored ICBT to PSP, primarily through offering case stories and PSP-specific examples within an ICBT program. PSPNET’s first and most frequently used ICBT program, called the PSP Wellbeing Course, has been found to reduce symptoms of mental disorders (eg, anxiety, depression, and posttraumatic stress) among PSP. Little research, however, has investigated clients’ perceptions of the case stories in this course. Objective: This study was designed to expand the literature on the use and evaluation of case stories in ICBT among PSP. Specifically, this study investigated (1) PSP’s perceptions of the case stories using the theoretical model provided by Shaffer and Zikmund-Fisher and (2) PSP feedback on the case stories in the PSP Wellbeing Course. Methods: This study included 41 clients who completed the PSP Wellbeing Course. Of these, 27 clients completed a bespoke questionnaire called the Stories Questionnaire, 10 of whom also participated in a semistructured interview. Results: Findings show that perceptions of the case stories in the PSP Wellbeing Course were largely positive and that the case stories were generally successful in achieving the 5 purposes of case stories (ie, informing, comforting, modeling, engaging, and persuading) proposed by Shaffer and Zikmund-Fisher. Client feedback also identified 3 tangible areas for story improvement: characters, content, and delivery. Each area highlights the need for and potential benefits of story development. Not all PSP engaged with the case stories, though, so results must be interpreted with caution. Conclusions: Overall, this study adds to the growing body of research supporting the use of case stories in internet-delivered interventions among PSP. Trial Registration: ClinicalTrials.gov NCT04127032; https://www.clinicaltrials.gov/ct2/show/NCT04127032 %M 39453705 %R 10.2196/64454 %U https://formative.jmir.org/2024/1/e64454 %U https://doi.org/10.2196/64454 %U http://www.ncbi.nlm.nih.gov/pubmed/39453705 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56693 %T Brief Mobile App–Based Mindfulness Intervention for Indonesian Senior High School Teachers: Protocol for a Pilot Randomized Controlled Trial %A Dantes,Gede Rasben %A Asril,Nice Maylani %A Liem,Andrian %A Suwastini,Ni Komang Arie %A Keng,Shian-Ling %A Mahayanti,Ni Wayan Surya %+ Faculty of Education, Universitas Pendidikan Ganesha, Jalan Udayana No 11, Singaraja, Bali, 81116, Indonesia, 62 82145158155, nicemaylani.asril@undiksha.ac.id %K digital mental health %K telemedicine %K anxiety %K stress %K self-efficacy %K life satisfaction %K self-compassion %K mindfulness %K feasibility study %K mobile app %K mindfulness-based stress reduction %K stress management %D 2024 %7 23.10.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The COVID-19 pandemic has increased the level of anxiety among Indonesian senior high school teachers, who face challenges to treat their mental disorder symptoms that arise during their working hours, as mental health services in Indonesia are limited. Therefore, it is vital to equip schoolteachers in Indonesia with early interventions that are easily available, private, and affordable, and 1 feasible approach is to deploy a smartphone mobile app. Objective: The objectives of this study are (1) to evaluate the feasibility of a brief mindfulness–based mobile app (BM-MA) for Indonesian senior high school teachers experiencing anxiety and stress and (2) to examine the effects of using the BM-MA on anxiety, stress, life satisfaction, self-efficacy, trait mindfulness, self-compassion, and physical and social dysfunction among the participants. Methods: We followed the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement for this feasibility randomized controlled trial (RCT) protocol. A total of 60 Indonesian senior high school teachers were recruited for this study and randomly assigned to either the intervention group (BM-MA) or a wait-list control group (CG) in a 1:1 ratio. The BM-MA group was required to engage in mindfulness practices using the app for 10-20 minutes per day for 3 weeks. All participants were assessed with a battery of self-report measures at baseline, postintervention, and at 1-month follow-up. Validated scales used to measure the outcome variables of interest included the Satisfaction With Life Scale (SLS), the Teachers’ Sense of Efficacy Scale (TSES), the Self-Compassion Scale—Short Form (SCS-SF), Generalized Anxiety Disorder-7 (GAD-7), General Health Questionnaire-12 (GHQ-12), and the Five Facet Mindfulness Questionnaire (FFMQ). The practicality and acceptability of the app will be evaluated using the Client Satisfaction Questionnaire-8 (CSQ-8) and structured qualitative interviews. Data from the interviews will be analyzed with the deductive thematic analysis framework as a process of qualitative inquiry. Repeated measures ANOVA with groups (intervention vs control) as a between-subject factor and time as a within-subject factor (baseline, postintervention, and 1-month follow-up) will be used to examine the effects of the BM-MA on the outcome variables. The data will be analyzed using an intent-to-treat approach and published in accordance with CONSORT (Consolidated Standards of Reporting Trials) recommendations. Results: Participants were recruited in December 2023, and this pilot RCT was conducted from January through March 2024. Data analysis was conducted from March through May 2024. The results of this study are expected to be published in December 2024. The trial registration of this protocol was submitted to the Chinese Clinical Trial Registry. Conclusions: This study aims to determine the feasibility and efficacy of the BM-MA, a digital mental health intervention developed using an existing mindfulness-based app, and assess its potential for widespread use. Trial Registration: Chinese Clinical Trial Registry ChiCTR2300068085; https://tinyurl.com/2d2x4bxk International Registered Report Identifier (IRRID): DERR1-10.2196/56693 %M 39442169 %R 10.2196/56693 %U https://www.researchprotocols.org/2024/1/e56693 %U https://doi.org/10.2196/56693 %U http://www.ncbi.nlm.nih.gov/pubmed/39442169 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e51322 %T A Person-Based Web-Based Sleep Intervention Aimed at Adolescents (SleepWise): Randomized Controlled Feasibility Study %A Moghadam,Shokraneh %A Husted,Margaret %A Aznar,Ana %A Gray,Debra %+ Department of Psychology, University of Winchester, Sparkford Rd, Winchester, SO22 4NR, United Kingdom, 44 01392 72 5950, s.oftadeh-moghadam@exeter.ac.uk %K web-based health interventions %K sleep %K adolescence %K behavior change %K person-based approach %K sleep intervention %K detrimental health outcome %K SleepWise %D 2024 %7 23.10.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Adolescents are advised to sleep 8-10 hours per night; however, most do not sleep for this recommended amount. Poor adolescent sleep is associated with detrimental health outcomes, including reduced physical activity, risk-taking behaviors, and increased depression and anxiety levels, making this an important public health concern. Existing interventions targeting adolescent sleep are often unsuccessful or their effectiveness unclear, as they are frequently noninteractive, time-consuming, and lack a strong theoretical foundation; highlighting an urgent need for innovative interventions deemed acceptable by adolescents. Objective: The main objective of this study was to determine the acceptability, feasibility, and preliminary impact of a web-based person-based sleep intervention (SleepWise) on adolescent sleep quality. Participant incentivization was also explored to understand its impact on engagement, acceptability, and sleep quality. Methods: A feasibility trial was conducted to test the feasibility, acceptability, and preliminary impact of SleepWise on adolescent sleep quality, developed based on the person-based approach to intervention development. In total, 90 participants (aged 13-17 years) from further education institutions and secondary schools were recruited for two 2-arm randomized controlled trials. One trial (trial 1) was incentivized to understand the impact of incentivization. Acceptability and sleep quality were assessed via questionnaires, and a mixed methods process evaluation was undertaken to assess participant engagement and experience with SleepWise. Engagement was automatically tracked by SleepWise, which collected data on the date and time, pages viewed, and the number of goals and sleep logs completed per participant. Semistructured interviews were carried out to gain participant feedback. Results: Participants in both trials reported high levels of acceptability (trial 1: mean 21.00, SD 2.74; trial 2: mean 20.82, SD 2.48) and demonstrated similar levels of engagement with SleepWise. Participants in trial 1 viewed slightly more pages of the intervention, and those in trial 2 achieved their set goals more frequently. Improvements in sleep quality were found in both trials 1 and 2, with medium (trial 1) and large (trial 2) effect sizes. A larger effect size for improvement in sleep quality was found in the nonincentivized trial (d=0.87), suggesting that incentivization may not impact engagement or sleep quality. Both trials achieved acceptable recruitment (trial 1, N=48; trial 2, N=42), and retention at 5 weeks (trial 1: N=30; trial 2: N=30). Qualitative findings showed that adolescents lead busy lifestyles, which may hinder engagement; however, participants deemed SleepWise acceptable in length and content, and made attempts at behavior change. Conclusions: SleepWise is an acceptable and potentially efficacious web-based sleep intervention aimed at adolescents. Findings from this study showed that incentivization did not greatly impact engagement, acceptability, or sleep quality. Subject to a full trial, SleepWise has the potential to address the urgent need for innovative, personalized, and acceptable sleep interventions for adolescents. Trial Registration: OSF Registries osf.io/yanb2; https://osf.io/yanb2 %M 39442165 %R 10.2196/51322 %U https://formative.jmir.org/2024/1/e51322 %U https://doi.org/10.2196/51322 %U http://www.ncbi.nlm.nih.gov/pubmed/39442165 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e60962 %T Integrated Online-to-Offline Model of Care for HIV Prevention and Treatment Among Men Who Have Sex With Men in Malaysia: Protocol for an Intervention Development and a Multiphase Trial %A Khati,Antoine %A Wickersham,Jeffrey A %A Gautam,Kamal %A Paudel,Kiran %A Phiphatkhunarnon,Panyaphon %A Lim,Sin How %A Puniamurthy,Kirthana %A Altice,Frederick L %A Phanuphak,Nittaya %A Azwa,Iskandar %A Shrestha,Roman %+ Department of Allied Health Sciences, University of Connecticut, 2019 Hillside Road Unit, Storrs Mansfield, CT, 06269, United States, 1 860 486 2446, roman.shrestha@uconn.edu %K HIV %K HIV testing %K pre-exposure prophylaxis %K antiretroviral therapy %K CINTAI %K men who have sex with men %K online-to-offline model %K eHealth %D 2024 %7 23.10.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: HIV continues to have a disproportionate impact on specific populations in Malaysia, particularly men who have sex with men (MSM). HIV self-testing (HIVST) is a strategy that has been shown to scale up HIV testing rates. However, it faces shortcomings because of concerns about self-efficacy, result interpretation, and lack of counseling and linkage to care. This underscores the need for an innovative approach that integrates HIVST with timely counseling, expert guidance, and referrals to enhance engagement in relevant HIV prevention or treatment. Objective: This study aims to describe the protocol used in developing and testing a web-based platform (ie, CINTAI) providing an HIVST kit and real-time e-counseling to support online-to-offline linkage to HIV care services for MSM in Malaysia. Methods: The methods are reported according to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 guidelines. In phase I, we will adapt existing HIVST web-based platforms to create a new online-to-offline HIVST and counseling platform called “CINTAI” for Malaysian MSM. In phase II, we will use a type 1 hybrid implementation trial design to determine the feasibility, acceptability, and preliminary efficacy of “CINTAI” compared with treatment as usual among Malaysian MSM, with assessments conducted over 6 months. Multilevel implementation factors will also be collected to guide future adoption and scale-up. We will enroll 78 MSM in the pilot randomized controlled trial. Baseline characteristics will be tested for homogeneity between groups using appropriate statistical tests. A generalized linear mixed model with random subject effects will account for within-subject correlation. Treatment assignment, time, interaction, and confounders will be included. The proportion of MSM tested for HIV over 6 months and other outcomes (pre-exposure prophylaxis for HIV or antiretroviral therapy linkage, HIV risk behaviors, and chemsex harm reduction) will be compared using linear contrasts. Results: We completed phase I of the proposed study in April 2024 and started phase II in May 2024, with 15 participants recruited (7 in the CINTAI and 8 in the treatment-as-usual groups). On the basis of a series of formative works completed during phase I, we developed a fully functional, web-based platform that provides a digital platform for MSM in Malaysia to order HIVST kits for free and to receive HIV counseling, followed by offline linkage to HIV prevention services (if HIV negative) or HIV treatment services (if HIV positive). Conclusions: Despite being at high risk for HIV transmission, MSM in Malaysia have alarmingly low testing and linkage to HIV care services, prompting the need for innovative approaches to support HIV prevention efforts. If found to be feasible and acceptable, CINTAI can be easily adapted for a range of health outcomes and health care delivery services for MSM, including adaptation to other low- and middle-income countries. International Registered Report Identifier (IRRID): DERR1-10.2196/60962 %M 39441624 %R 10.2196/60962 %U https://www.researchprotocols.org/2024/1/e60962 %U https://doi.org/10.2196/60962 %U http://www.ncbi.nlm.nih.gov/pubmed/39441624 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e54978 %T Behavior Change Techniques Used in Self-Management Interventions Based on mHealth Apps for Adults With Hypertension: Systematic Review and Meta-Analysis of Randomized Controlled Trials %A Zhou,You %A Li,Si-Jia %A Huang,Ren-Qian %A Ma,Hao-Ming %A Wang,Ao-Qi %A Tang,Xing-Yi %A Pei,Run-Yuan %A Piao,Mei-Hua %+ School of Nursing, Chinese Academy of Medical Sciences, Peking Union Medical College, 33 Badachu Road, Shijignshan District, Beijing, 100144, China, 86 13522112889, piaomeihua@nursing.pumc.edu.cn %K hypertension %K mHealth %K app %K behavior change technique %K systematic review %K meta-analysis %K mobile phone %D 2024 %7 22.10.2024 %9 Review %J J Med Internet Res %G English %X Background: Hypertension has become an important global public health challenge. Mobile health (mHealth) intervention is a viable strategy to improve outcomes for patients with hypertension. However, evidence on the effect of mHealth app interventions on self-management in patients with hypertension is yet to be updated, and the active ingredients promoting behavior change in interventions remain unclear. Objective: We aimed to evaluate the effect of mHealth app self-management interventions on blood pressure (BP) management and investigate the use of behavior change techniques (BCTs) in mHealth app interventions. Methods: We conducted a literature search in 6 electronic databases from January 2009 to October 2023 for studies reporting the application of mHealth apps in self-management interventions. The Cochrane Risk of Bias (version 2) tool for randomized controlled trials was used to assess the quality of the studies. BCTs were coded according to the Taxonomy of BCTs (version 1). The extracted data were analyzed using RevMan5.4 software (Cochrane Collaboration). Results: We reviewed 20 studies, of which 16 were included in the meta-analysis. In total, 21 different BCTs (mean 8.7, SD 3.8 BCTs) from 12 BCT categories were reported in mHealth app interventions. The most common BCTs were self-monitoring of outcomes of behavior, feedback on outcomes of behavior, instruction on how to perform the behavior, and pharmacological support. The mHealth app interventions resulted in a –5.78 mm Hg (95% CI –7.97 mm Hg to –3.59 mm Hg; P<.001) reduction in systolic BP and a –3.28 mm Hg (95% CI –4.39 mm Hg to –2.17 mm Hg; P<.001) reduction in diastolic BP. The effect of interventions on BP reduction was associated with risk factors, such as hypertension, that were addressed by the mHealth app intervention (multiple risk factors vs a single risk factor: –6.50 mm Hg, 95% CI –9.00 mm Hg to –3.99 mm Hg vs –1.54 mm Hg, 95% CI –4.15 mm Hg to 1.06 mm Hg; P=.007); the presence of a theoretical foundation (with vs without behavior change theory: –10.06 mm Hg, 95% CI –16.42 mm Hg to –3.70 mm Hg vs –4.13 mm Hg, 95% CI –5.50 to –2.75 mm Hg; P=.07); intervention duration (3 vs ≥6 months: –8.87 mm Hg, 95% CI –10.90 mm Hg to –6.83 mm Hg vs –5.76 mm Hg, 95% CI –8.74 mm Hg to –2.77 mm Hg; P=.09); and the number of BCTs (≥11 vs <11 BCTs: –9.68 mm Hg, 95% CI –13.49 mm Hg to –5.87 mm Hg vs –2.88 mm Hg, 95% CI –3.90 mm Hg to –1.86 mm Hg; P<.001). Conclusions: The self-management interventions based on mHealth apps were effective strategies for lowering BP in patients with hypertension. The effect of interventions was influenced by factors related to the study’s intervention design and BCT. %M 39437388 %R 10.2196/54978 %U https://www.jmir.org/2024/1/e54978 %U https://doi.org/10.2196/54978 %U http://www.ncbi.nlm.nih.gov/pubmed/39437388 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e48481 %T A Universal Digital Stress Management Intervention for Employees: Randomized Controlled Trial with Health-Economic Evaluation %A Freund,Johanna %A Smit,Filip %A Lehr,Dirk %A Zarski,Anna-Carlotta %A Berking,Matthias %A Riper,Heleen %A Funk,Burkhardt %A Ebert,David Daniel %A Buntrock,Claudia %+ Department of Health Psychology and Applied Biological Psychology, Leuphana University of Lueneburg, Universitätsallee 1, Lueneburg, 21335, Germany, 49 4131 677 2720, lehr@leuphana.de %K economic evaluation %K cost-effectiveness %K cost-utility %K cost-benefit %K return-on-investment %K employees %K universal prevention %K internet-based %K stress management %D 2024 %7 22.10.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Stress is highly prevalent and known to be a risk factor for a wide range of physical and mental disorders. The effectiveness of digital stress management interventions has been confirmed; however, research on its economic merits is still limited. Objective: This study aims to assess the cost-effectiveness, cost-utility, and cost-benefit of a universal digital stress management intervention for employees compared with a waitlist control condition within a time horizon of 6 months. Methods: Recruitment was directed at the German working population. A sample of 396 employees was randomly assigned to the intervention group (n=198) or the waitlist control condition (WLC) group (n=198). The digital stress management intervention included 7 sessions plus 1 booster session, which was offered without therapeutic guidance. Health service use, patient and family expenditures, and productivity losses were self-assessed and used for costing from a societal and an employer’s perspective. Costs were related to symptom-free status (PSS-10 [Perceived Stress Scale] score 2 SDs below the study population baseline mean) and quality-adjusted life years (QALYs) gained. The sampling error was handled using nonparametric bootstrapping. Results: From a societal perspective, the digital intervention was likely to be dominant compared with WLC, with a 56% probability of being cost-effective at a willingness-to-pay (WTP) of €0 per symptom-free person gained. At the same WTP threshold, the digital intervention had a probability of 55% being cost-effective per QALY gained relative to the WLC. This probability increased to 80% at a societal WTP of €20,000 per QALY gained. Taking the employer’s perspective, the digital intervention showed a probability of a positive return on investment of 78%. Conclusions: Digital preventive stress management for employees appears to be cost-effective societally and provides a favorable return on investment for employers. Trial Registration: German Clinical Trials Register DRKS00005699; https://drks.de/search/en/trial/DRKS00005699 %M 39437382 %R 10.2196/48481 %U https://www.jmir.org/2024/1/e48481 %U https://doi.org/10.2196/48481 %U http://www.ncbi.nlm.nih.gov/pubmed/39437382 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e58312 %T Effects of Monitoring Frailty Through a Mobile/Web-Based Application and a Sensor Kit to Prevent Functional Decline in Frail and Prefrail Older Adults: FACET (Frailty Care and Well Function) Pilot Randomized Controlled Trial %A Valdés-Aragonés,Myriam %A Pérez-Rodríguez,Rodrigo %A Carnicero,José Antonio %A Moreno-Sánchez,Pedro A %A Oviedo-Briones,Myriam %A Villalba-Mora,Elena %A Abizanda-Soler,Pedro %A Rodríguez-Mañas,Leocadio %+ Intelligent Robotics Lab, Universidad Rey Juan Carlos, Camino del Molino 5, 28942, Fuenlabrada, Spain, 34 914888401, rodrigo.perez@urjc.es %K frailty %K functional status %K older adults %K new technologies %K sensor %K monitoring system %K information and communication technologies %K mobile app %K sensor kit %K sensors %K technological ecosystem %K clinical intervention %D 2024 %7 22.10.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Frailty represents a state of susceptibility to stressors and constitutes a dynamic process. Untreated, this state can progress to disability. Hence, timely detection of alterations in patients’ frailty status is imperative to institute prompt clinical interventions and impede frailty progression. With this aim, the FACET (Frailty Care and Well Function) technological ecosystem was developed to provide clinically gathered data from the home to a medical team for early intervention. Objective: The aim of this study was to assess whether the FACET technological ecosystem prevents frailty progression and improves frailty status, according to the frailty phenotype criteria and Frailty Trait Scale-5 items (FTS-5) at 3 and 6 months of follow-up. Methods: This randomized clinical trial involved 90 older adults aged ≥70 years meeting 2 or more Fried frailty phenotype criteria, having 4 or more comorbidities, and having supervision at home. This study was conducted between August 2018 and June 2019 at the geriatrics outpatient clinics in Getafe University Hospital and Albacete University Hospital. Participants were randomized into a control group receiving standard treatment and the intervention group receiving standard treatment along with the FACET home monitoring system. The system monitored functional tests at home (gait speed, chair stand test, frailty status, and weight). Outcomes were assessed using multivariate linear regression models for continuous response and multivariate logistic models for dichotomous response. P values less than .05 were considered statistically significant. Results: The mean age of the participants was 82.33 years, with 28% (25/90) being males. Participants allocated to the intervention group showed a 74% reduction in the risk of deterioration in the FTS-5 score (P=.04) and 92% lower likelihood of worsening by 1 point according to Fried frailty phenotype criteria compared to the control group (P=.02) at 6 months of follow-up. Frailty status, when assessed through FTS-5, improved in the intervention group at 3 months (P=.004) and 6 months (P=.047), while when the frailty phenotype criteria were used, benefits were shown at 3 months of follow-up (P=.03) but not at 6 months. Conclusions: The FACET technological ecosystem helps in the early identification of changes in the functional status of prefrail and frail older adults, facilitating prompt clinical interventions, thereby improving health outcomes in terms of frailty and functional status and potentially preventing disability and dependency. Trial Registration: ClinicalTrials.gov NCT03707145; https://clinicaltrials.gov/study/NCT03707145 %M 39436684 %R 10.2196/58312 %U https://www.jmir.org/2024/1/e58312 %U https://doi.org/10.2196/58312 %U http://www.ncbi.nlm.nih.gov/pubmed/39436684 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e59246 %T Feasibility and Acceptability of a Self-Guided Digital Family Skills Management Intervention for Children Newly Diagnosed With Type 1 Diabetes: Pilot Randomized Controlled Trial %A Hughes Lansing,Amy %A Cohen,Laura B %A Glaser,Nicole S %A Loomba,Lindsey A %+ Division of Endocrinology, Department of Pediatrics, University of California Davis Medical Center, 2516 Stockton Blvd, Suite 384, Sacramento, CA, 95817, United States, 1 916 734 7098, laalbrecht@ucdavis.edu %K type 1 diabetes %K children %K family support %K family dynamics %K web-based intervention %K feasibility %K acceptability %K self-guided %K intervention %K diabetes %K RCT %K randomized controlled trial %K psychosocial %K well-being %K caregiver %K communication %D 2024 %7 21.10.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Family dynamics play an important role in determining the glycemic outcomes of type 1 diabetes (T1D) in children. The time interval immediately following T1D diagnosis is particularly stressful for families, and interventions to support families in adjusting their family practices to support adjustment to and management of T1D in the months following diagnosis may improve glycemic outcomes. Self-guided digital interventions offer a sustainable model for interventions to support caregivers in learning evidence-based family management skills for adjustment to and management of T1D. Objective: We hypothesized that a self-guided, web-based, family skills management program (addressing caregiver social support as well as family problem-solving, communication, and supportive behavior change strategies) initiated at the time of T1D diagnosis would improve glycemic outcomes in children with T1D. In this study, we report on the feasibility and acceptability of this program. Methods: We prospectively evaluated a sample of 37 children newly diagnosed with T1D recruited from a pediatric endocrinology clinic. Parent participants were asked to complete web-based modules addressing social support, family problem-solving, communication, and supportive behavior change strategies. Module completion was analyzed for percentage completion, patterns of completion, and differences in completion rates by coparenting status. Qualitative open-ended feedback was collected at the completion of each module. Results: A total of 31 (84%) of the 37 participants initiated the web-based program. Of those 31 participants, 25 (81%) completed some content and 15 (48%) completed all 5 modules. Completion rates were higher when coparenting partners engaged in the intervention together (P=.04). Of the 18 participants given a choice about the spacing of content delivery, 15 (83%) chose to have all sessions delivered at once and 3 (17%) chose to space sessions out at 2-week intervals. Qualitative feedback supported the acceptability of the program for delivery soon after T1D diagnosis. Families reported on positive benefits, including requesting future access to the program and describing helpful changes in personal or family processes for managing T1D. Conclusions: In this study, we found that a self-guided digital family support intervention initiated at the time of a child’s T1D diagnosis was largely feasible and acceptable. Overall, rates of participation and module completion were similar to or higher than other self-guided digital prevention interventions for mental and physical health outcomes. Self-guided digital programs addressing family management skills may help prevent challenges common with T1D management and can decrease cost, increase access, and add flexibility compared to traditional interventions. Trial Registration: ClinicalTrials.gov NCT03720912; https://clinicaltrials.gov/study/NCT03720912 %M 39432892 %R 10.2196/59246 %U https://formative.jmir.org/2024/1/e59246 %U https://doi.org/10.2196/59246 %U http://www.ncbi.nlm.nih.gov/pubmed/39432892 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e55075 %T Feasibility, Preference, and Impact of a Rapid Multiplexed Point-of-Care Digital Innovation (AideSmart!) to Expedite Screening of Sexually Transmitted Blood-Borne Infections in At-Risk Populations in Canada: Cross-Sectional Study %A Karellis,Angela %A Webster,Duncan %A Boulanger,Jean %A Harland,Kate %A Feltmate,Paige %A Materniak,Stefanie %A Daunais-Laurin,Gabriel %A Mesa,Christine %A Vaikla,Olivia %A Kim,John %A Pant Pai,Nitika %+ Infectious Diseases and Immunity in Global Health, Research Institute of the McGill University Health Centre, 5252 boul de Maisonneuve Ouest, Montreal, QC, H4A3S5, Canada, 1 514 934 1934 ext 44729, nitika.pai@mcgill.ca %K sexually transmitted blood-borne infections %K rapid multiplexed biomarker-based screening %K digital strategy %K feasibility %K preference %K impact %D 2024 %7 18.10.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: With the need to expedite the detection of multiple sexually transmitted blood-borne infections (STBBIs), there is an increased demand for digital innovations and tests that improve the efficiency of point-of-care testing in outreach community settings. Multiplexed testing is being offered to at-risk populations by frontline health care professionals. Objective: With this in mind, we evaluated AideSmart! (for health aides or health care workers), an integrated app and platform solution that enables multiplexed STBBI screening at the point of care, for feasibility, preference, accuracy, and impact. With AideSmart!, we provided trained health care workers with the ability to perform rapid multiplexed tests; offer STBBI pre- or posttest counseling; maintain quality assurance of testing; facilitate linkages to care; and enhance health care provider–patient communication, data documentation, and patient engagement through the multiplexed STBBI screening and linkage process. We evaluated the performance of multiplexed tests. Methods: In a cross-sectional study conducted during the COVID-19 pandemic, we recruited at-risk populations in Canada from community-based organizations in Montreal, Quebec, and Saint John, New Brunswick, with unknown serostatus for HIV, hepatitis C virus (HCV), and syphilis. Following orientation and pretest counseling with AideSmart!, we performed multiplexed tests, simultaneously screening for HIV, HCV, and syphilis, using 2 rapid investigational multiplexed tests (Chembio for HIV and syphilis and MedMira for HIV, HCV, and syphilis) followed by confirmatory testing from local and national laboratories. Results: Of the 401 participants, all (100%) accepted the AideSmart! multiplexed strategy: 59.4% (148/249) preferred multiplexed rapid tests over laboratory tests, and 56.6% (141/249) preferred receiving same-day test results. Rapid test results were obtained in 15 minutes (vs laboratory tests at 4-24 days). A total of 29 new infections (n=27, 93% HCV; n=1, 3% syphilis; and n=1, 3% HIV) were identified and treated within a week. Feasibility of the strategy (completion of testing and linkages to care) was at 76.1% (305/401). Health care professionals provided positive feedback and emphasized the importance of knowing one’s negative or positive serostatus, especially during a pandemic. Multiplexed rapid tests’ specificity (against laboratory reference standards) exceeded 98% (98.7%-100%) for all pathogens and devices. An electronic reader, used by the Chembio rapid test, enhanced sensitivity (HIV: 100%, 95% CI 79.4%-100%; syphilis: 86.8%, 95% CI 71.9%-95.6% [Chembio] vs HIV: 100%, 95% CI 78.2%-100%; HCV: 90.3%, 95% CI 80.1%-96.4%; and syphilis: 57.9%, 95% CI 40.8%-73.7% [MedMira]). Conclusions: The AideSmart! digital multiplexed rapid screening strategy for health care workers facilitated STBBI testing for multiple STBBIs and arranged for pre- or posttest counseling and rapid linkages with high feasibility and acceptability. Electronic readers enhanced the diagnostic performance of multiplexed biomarker tests. This study generated data in support of digital multiplexed strategies in digitally enabled settings for at-risk populations nationally and worldwide. %R 10.2196/55075 %U https://www.jmir.org/2024/1/e55075 %U https://doi.org/10.2196/55075 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e52302 %T Technology-Supported Physical Activity and Its Potential as a Tool to Promote Young Women’s Physical Activity and Physical Literacy: Systematic Review %A Watson-Mackie,Kimberley %A Arundell,Lauren %A Lander,Natalie %A McKay,Fiona H %A Jerebine,Alethea %A Venetsanou,Fotini %A Barnett,Lisa M %+ School of Health and Social Development, Faculty of Health, Deakin University, 221 Burwood Highway, Burwood, 3125, Australia, kwatsonm@deakin.edu.au %K physical literacy %K young women %K girls %K adolescents %K technology %K mobile %K digital %K fitness %K exercise %K physical activity %K technology-supported %K systematic review %K digital health %K eHealth %K health informatics %K mobile phone %D 2024 %7 18.10.2024 %9 Review %J J Med Internet Res %G English %X Background: Despite the known benefits of physical activity (PA), rates of engagement in PA remain low globally. Low engagement in PA among young women can impact their health. Technology-supported PA may increase PA and physical literacy (PL; skills that can support PA) among young women. Objective: This systematic review aims to investigate the (1) associations between technology-supported PA and PA levels, (2) associations between technology-supported PA and PL levels, and (3) types of technology-supported PA that are associated with higher levels of PA engagement among young women aged 13 to 24 years. This age range was chosen as it includes two transitional periods characterized by decreases in PA. Methods: We searched 6 databases: Applied Science and Technology Source, Education Source, Embase, MEDLINE Complete, Global Health, and SPORTDiscus. Eligible studies were original research published in English between January 1, 2010, and April 24, 2024; focused on young women; and involving either technology-supported PA interventions or research exploring the correlation between technology and PA and PL. The findings of the review were presented descriptively. Study quality was assessed using the JBI Critical Appraisal tools. There were no deviations from the registered protocol. Results: In total, 23 (0.1%) studies (10,233 participants) from 23,609 records were included: randomized controlled trials (n=9, 39%), nonrandomized or retrospective observational studies (n=9, 39%), and cross-sectional studies (n=5, 22%). Of the 23 studies, 12 (52%) focused on young adults (aged ≥19 y), 9 (39%) involved adolescents (aged <19 y), and 2 (9%) focused on both groups. Nine studies (39%) were theory based. Common types of technology-supported PA were interactive websites or social media platforms (10/23, 43%), wearable fitness trackers (4/23, 17%), and mobile apps (4/23, 17%). PA or PL were predominantly self-reported (18/23, 78%). A total of 53 PA outcomes were measured: 36% (19/53) reported a positive impact on PA from mobile apps (9/15; 60% of analyses), interactive websites or social media platforms (8/27; 30% of analyses) and wearable fitness trackers (2/11; 18% of analyses). The impact on PL was weak (2/7; 29% of analyses). Eight studies (35%) were rated high, 7 (30%) medium, and 8 (35%) low in quality. Conclusions: There was limited evidence that technology-supported PA improved young women’s PA or PL. The evidence was limited by poor study quality and a lack of theoretical frameworks. In addition, little information was provided on the designs of the technology used. Future interventions seeking to improve young women’s PA and PL should focus on the development of mobile apps underpinned by behavior change theory and addressing whole domains of PL rather than specific elements. Given that technology continues to rapidly advance, further studies are needed to demonstrate the impact of technology-supported PA in improving PA and PL among young women. %M 39423006 %R 10.2196/52302 %U https://www.jmir.org/2024/1/e52302 %U https://doi.org/10.2196/52302 %U http://www.ncbi.nlm.nih.gov/pubmed/39423006 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e60502 %T Clinical Effects of Asynchronous Provider-Guided Practice Sessions During Blended Care Therapy for Anxiety and Depression: Pragmatic Retrospective Cohort Study %A Espel-Huynh,Hallie M %A Wang,Lu %A Lattie,Emily G %A Wickham,Robert E %A Varra,Alethea %A Chen,Connie E %A Lungu,Anita %A Lee,Jennifer L %+ Lyra Health, 270 East Lane, Burlingame, CA, 94010, United States, 1 (877) 505 7147, hespel-huynh@lyrahealth.com %K anxiety %K depression %K blended care therapy %K guided practice sessions %K mental health care %K digital mental health %K psychotherapy outcomes %D 2024 %7 18.10.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Blended care therapy models are intended to increase the efficiency and effectiveness of evidence-based psychotherapy by combining synchronous and asynchronous components of care. Objective: This retrospective cohort study evaluated the clinical effects of synchronous video therapy sessions and asynchronous guided practice session elements on anxiety and depression in a blended care therapy program, with a novel focus on asynchronous provider feedback messages. Methods: Participants were adults (N=33,492) with clinical symptoms of anxiety (Generalized Anxiety Disorder 7-item scale [GAD-7] score of ≥8) and depression (Patient Health Questionnaire 9-item scale [PHQ-9] score of ≥10) at intake. Symptom trajectories were evaluated via individual growth curve models. Time-varying covariates evaluated effects of synchronous video session attendance and the presence or absence of each asynchronous guided practice session element occurring within 7 days and 8-14 days prior to each clinical outcome assessment. Guided practice session elements included client digital lesson completion, client digital exercise completion, and feedback messages sent by providers. Results: Approximately 86.6% (29,012/33,492) of clients met criteria for clinical improvement by end of care (median 6, IQR 4-8 synchronous sessions). Synchronous video session attendance and client digital lesson completion in the past 7 days and in the past 8-14 days were each uniquely and significantly associated with lower GAD-7 scores (video session effects: bsession7=–0.82, bsession8-14=–0.58, P values<.001; digital lesson effects: blesson7=–0.18, blesson8-14=–0.26, P values <.001) and PHQ-9 scores (video session effects: bsession7=–0.89, bsession8-14=–0.67, P values <.001; digital lesson effects: blesson7=–0.12, blesson8-14=–0.30, P values <.001). Client digital exercise completion in the past 8-14 days was significantly associated with lower GAD-7 scores (bexercise8-14=–0.10; P<.001) but exercise completion in the 7 days prior to clinical outcome assessment was not (bexercise7=0.00; P=.89). Exercise completion in the past 7 days was significantly associated with lower PHQ-9 scores (bexercise7=–0.16; P<.001) but exercise completion in the past 8-14 days was not (bexercise8-14=–0.05; P=.09). Provider feedback messaging in the past 7 days and in the past 8-14 days was significantly associated with lower GAD-7 and PHQ-9 scores, respectively (GAD-7: bfeedback7=–0.12, P<.001; bfeedback8-14=–0.07, P=.004; PHQ-9: bfeedback7=–0.15, P<.001; bfeedback8-14=–0.08, P=.01). Conclusions: Provider feedback between synchronous therapy sessions provided significant benefit for symptom reduction, beyond the effects of client digital engagement and synchronous video sessions. When guided practice sessions are well integrated into care, blended care therapy provides meaningful improvements upon the traditional, synchronous session–only therapy model. Provider guidance and feedback for clients between synchronous sessions support more efficient and effective mental health care overall. %M 39422996 %R 10.2196/60502 %U https://www.jmir.org/2024/1/e60502 %U https://doi.org/10.2196/60502 %U http://www.ncbi.nlm.nih.gov/pubmed/39422996 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e57322 %T Outcomes of a Remotely Delivered Complementary and Integrative Health Partnered Intervention to Improve Chronic Pain and Posttraumatic Stress Disorder Symptoms: Randomized Controlled Trial %A Haun,Jolie N %A Fowler,Christopher A %A Venkatachalam,Hari H %A Alman,Amy C %A Ballistrea,Lisa M %A Schneider,Tali %A Benzinger,Rachel C %A Melillo,Christine %A Alexander,Neil B %A Klanchar,S Angel %A Lapcevic,William A %A Bair,Matthew J %A Taylor,Stephanie L %A Murphy,Jennifer L %A French,Dustin D %+ Research and Development Service, James A Haley Veterans' Hospital, 8900 Grand Oak Circle, Tampa, FL, 33637, United States, 1 813 558 7622, rachel.benzinger@VA.Gov %K posttraumatic stress disorder %K PTSD %K pain %K veteran %K attrition %K complementary and integrative health %K CIH %K randomized controlled trial %K chronic pain %K remote intervention %K dyad %K mobile health %D 2024 %7 18.10.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Nonpharmacological interventions for veterans are needed to help them manage chronic pain and posttraumatic stress disorder (PTSD) symptoms. Complementary and integrative health (CIH) interventions such as Mission Reconnect (MR) seek to provide veterans with the option of a partnered, self-directed intervention that teaches CIH skills remotely to support symptom management. Objective: The purpose of this study was to describe the physical, psychological, and social outcomes of a self-directed mobile- and web-based CIH intervention for veterans with comorbid chronic pain and PTSD and their partners and qualitatively examine their MR user experience. Methods: A sample of veteran-partner dyads (n=364) were recruited to participate in a mixed methods multisite waitlist control randomized controlled trial to measure physical, psychological, and social outcomes, with pain as the primary outcome and PTSD, depression, stress, sleep, quality of life, and relationships as secondary outcomes. Linear mixed models were constructed for primary and secondary patient-reported outcomes. The quantitative analysis was triangulated using qualitative interviews from a subsample of dyads (n=35) to examine participants’ perceptions of their program experience. Results: Dyads were randomized to 2 groups: intervention (MR; 140/364, 38.5%) and waitlist control (136/364, 37.4%). No significant change was observed in overall pain, sleep, PTSD, quality of life, relationship satisfaction, overall self-compassion, or compassion for others. A significant reduction in pain interference in mood (P=.008) and sleep (P=.008) was observed among the veteran MR group that was not observed in the waitlist control group. We also observed a positive effect of the MR intervention on a reduction in negative affect associated with pain (P=.049), but this effect did not exceed the adjusted significance threshold (P=.01). Significant improvements were also observed for partners in the affection (P=.007) and conflict (P=.001) subdomains of the consensus and satisfaction domains. In contrast to quantitative results, qualitative data indicated that intervention impacts included improved sleep and reduced pain, anxiety, and stress and, in contrast to the survey data, overall improvement in PTSD symptoms and social relationships. Participants’ overall impressions of MR highlight usability and navigation, perceptions on packaging and content, and barriers to and facilitators of MR use. Conclusions: Adjunctive CIH-based modalities can be delivered using web and mobile apps but should be developed and tailored using established best practices. MR may be beneficial for veterans with pain and PTSD and their partners. Further pragmatic trials and implementation efforts are warranted. Trial Registration: ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/study/NCT03593772 International Registered Report Identifier (IRRID): RR2-10.2196/13666 %M 39422992 %R 10.2196/57322 %U https://www.jmir.org/2024/1/e57322 %U https://doi.org/10.2196/57322 %U http://www.ncbi.nlm.nih.gov/pubmed/39422992 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e49802 %T Comparing a Digital Health Check With Traditional Nurse-Led Health Examinations Among Long-Term Unemployed Individuals: Comparison Study %A Raussi,Venla %A Kujala,Sari %A Hörhammer,Iiris %A Savolainen,Kaisa %A Autio,Reija %A Koskela,Tuomas %+ Faculty of Medicine and Health Technology, Tampere University, Arvo Ylpön katu 34, Tampere, 33520, Finland, 358 403564154, venla.raussi@tuni.fi %K chronic illnesses %K eHealth %K health care services %K lifestyle %K long-term unemployment %K digital health check %K primary prevention %K risk assessment %K risk factors %K prevention %K screening %D 2024 %7 16.10.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: A digital health check can be used to screen health behavior risks in the population, help health care professionals with standardized risk estimation for their patients, and motivate a patient to change unhealthy behaviors. Long-term unemployed individuals comprise a particular subgroup with an increased risk of lifestyle-related diseases. Objective: This study aims to investigate the clinical utility of a general digital health examination, the STAR Duodecim Health Check and Coaching Program (STAR), which was developed in Finland, in the targeted screening of long-term unemployed individuals. For this purpose, we compared health challenges identified by a digital health check with those identified by a nurse during a face-to-face health check for unemployed individuals. Methods: In this comparison study, 49 unemployed participants attending a health check were recruited from two Finnish primary health care centers. The participants used STAR and attended a nurse’s health check. Data were collected by surveys with multiple-choice and open-ended questions from the participants, nurses, and a study assistant who observed the session. The nurses were asked to name the three most significant health challenges for each participant. These health challenges were categorized into health challenges corresponding to STAR and these were compared with each other. Percentages of agreement between STAR and nurses were calculated. Sensitivity and specificity, as well as Cohen κ with P values and CIs, were computed for agreement. Results: STAR identified a total of 365 health challenges, an average of 7.4 (SD 2.5) health challenges per participant (n=49). The nurses named a total of 160 health challenges (n=47). In 53% (95% CI 38.1-67.9; n=25) of cases, STAR identified all categorized health challenges named by nurses. In 64% (95% CI 48.5-77.3; n=30) of cases, STAR identified at least 2/3 of the health challenges identified by nurses. Cohen κ was 0.877 (P<.001) for alcohol, indicating almost perfect agreement, and 0.440 (P<.001) for smoking and 0.457 (P=.001) for cholesterol, indicating moderate agreement. STAR left a total of 89 health challenges, an average of 1.8 (SD 1.1) per participant, uncategorized because STAR lacked an answer to the question or questions required for the classification of a certain health challenge. The participants did not always add information on their blood pressure (n=36, 74%), cholesterol (n=22, 45%), and waist circumference (n=15, 31%). Conclusions: In conclusion, STAR identified most of the health challenges identified by nurses but missed some essential ones. Participants did not have information on measurements, such as blood pressure and cholesterol values, which are pivotal to STAR in assessing cardiovascular risks. Using the tool for screening or as a part of a traditional health check with necessary measurements and dialog with health care professionals may improve the risk assessments and streamline the health checks of unemployed individuals. International Registered Report Identifier (IRRID): RR2-10.2196/27668 %M 39412874 %R 10.2196/49802 %U https://www.jmir.org/2024/1/e49802 %U https://doi.org/10.2196/49802 %U http://www.ncbi.nlm.nih.gov/pubmed/39412874 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e62762 %T WhatsApp Versus SMS for 2-Way, Text-Based Follow-Up After Voluntary Medical Male Circumcision in South Africa: Exploration of Messaging Platform Choice %A Fabens,Isabella %A Makhele,Calsile %A Igaba,Nelson Kibiribiri %A Hlongwane,Sizwe %A Phohole,Motshana %A Waweru,Evelyn %A Oni,Femi %A Khwepeya,Madalitso %A Sardini,Maria %A Moyo,Khumbulani %A Tweya,Hannock %A Wafula,Mourice Barasa %A Pienaar,Jacqueline %A Ndebele,Felex %A Setswe,Geoffrey %A Dong,Tracy Qi %A Feldacker,Caryl %+ International Training and Education Center for Health (I-TECH), Departments of Global Health and Medicine, University of Washington, 13th Floor, 908 Jefferson Street, Seattle, WA, 98104, United States, 1 206 221 4970, cfeld@uw.edu %K 2-way texting %K text messages %K WhatsApp %K digital health innovations %K male circumcision %K South Africa %K quality improvement %D 2024 %7 16.10.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Telehealth is growing, especially in areas where access to health facilities is difficult. We previously used 2-way texting (2wT) via SMS to improve the quality of postoperative care after voluntary medical male circumcision in South Africa. In this study, we offered males aged 15 years and older WhatsApp or SMS as their message delivery and interaction platform to explore user preferences and behaviors. Objective: The objectives of this process evaluation embedded within a larger 2wT expansion trial were to (1) explore 2wT client preferences, including client satisfaction, with WhatsApp or SMS; (2) examine response rates (participation) by SMS and WhatsApp; and (3) gather feedback from the 2wT implementation team on the WhatsApp approach. Methods: Males aged 15 years and older undergoing voluntary medical male circumcision in program sites could choose their follow-up approach, selecting 2wT via SMS or WhatsApp or routine care (in-person postoperative visits). The 2wT system provided 1-way educational messages and an open 2-way communication channel between providers and clients. We analyzed quantitative data from the 2wT database on message delivery platforms (WhatsApp vs SMS), response rates, and user behaviors using chi-square tests, z tests, and t tests. The team conducted short phone calls with WhatsApp and SMS clients about their perceptions of this 2wT platform using a short, structured interview guide. We consider informal reflections from the technical team members on the use of WhatsApp. We applied an implementation science lens using the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework to focus results on practice and policy improvement. Results: Over a 2-month period—from August to October, 2023—337 males enrolled in 2wT and were offered WhatsApp or SMS and were included in the analysis. For 2wT reach, 177 (53%) participants chose WhatsApp as their platform (P=.38). Mean client age was 30 years, and 253 (75%) participants chose English for automated messages. From quality assurance calls, almost all respondents (87/89, 98%) were happy with the way they were followed up. For effectiveness, on average for the days on which responses were requested, 58 (33%) WhatsApp clients and 44 (28%) SMS clients responded (P=.50). All 2wT team members believed WhatsApp limited the automated message content, language choices, and inclusivity as compared with the SMS-based 2wT approach. Conclusions: When presented with a choice of 2wT communication platform, clients appear evenly split between SMS and WhatsApp. However, WhatsApp requires a smartphone and data plan, potentially reducing reach at scale. Clients using both platforms responded to 2wT interactive prompts, demonstrating similar effectiveness in engaging clients in follow-up. For telehealth interventions, digital health designers should maintain an SMS-based platform and carefully consider adding WhatsApp as an option for clients, using an implementation science approach to present evidence that guides the best implementation approach for their setting. %M 39412842 %R 10.2196/62762 %U https://formative.jmir.org/2024/1/e62762 %U https://doi.org/10.2196/62762 %U http://www.ncbi.nlm.nih.gov/pubmed/39412842 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e57294 %T A French-Language Web-Based Intervention Targeting Prolonged Grief Symptoms in People Who Are Bereaved and Separated: Randomized Controlled Trial %A Debrot,Anik %A Efinger,Liliane %A Kheyar,Maya %A Pomini,Valentino %A Berthoud,Laurent %+ Institute of Psychology, Faculty of Social and Political Sciences, University of Lausanne, Géopolis, Rue de la Mouline 11, Lausanne, 1015, Switzerland, 41 216923239, anik.debrot@unil.ch %K web-based interventions %K randomized controlled trial %K grief %K bereavement %K separation %K guidance %D 2024 %7 16.10.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Losing a loved one, through death or separation, counts among the most stressful life events and is detrimental to health and well-being. About 15% of people show clinically significant difficulties coping with such an event. Web-based interventions (WBIs) are effective for a variety of mental health disorders, including prolonged grief. However, no validated WBI is available in French for treating prolonged grief symptoms. Objective: This study aimed to compare the efficacy and adherence rates of 2 WBIs for prolonged grief symptoms following the loss of a loved one through death or romantic separation. Methods: LIVIA 2.0 was developed relying on theoretical and empirical findings on bereavement processes and WBIs, and is compared with LIVIA 1, which has already demonstrated its efficacy. We conducted a randomized controlled trial and provided on-demand guidance to participants. Outcomes were assessed through web-based questionnaires before the intervention, after the intervention (12 weeks later), and at follow-up (24 weeks later). Primary outcomes were grief symptoms, depressive symptoms, and well-being. Secondary outcomes were anxiety symptoms, grief coping strategies, aspects related to self-identity, and program satisfaction. Results: In total, 62 participants were randomized (intent-to-treat [ITT] sample), 29 (47%) in LIVIA 2.0 (active arm) and 33 (53%) in LIVIA 1 (control arm). The dropout rate was 40% (37/62), and 10 participants were removed due to exclusion criteria, leading to a final per-protocol sample of 27 (44%) completers who differed from noncompleters only based on reporting fewer anxiety symptoms (t60=3.03; P=.004). Participants who are separated reported more grief symptoms (t60=2.22; P=.03) and attachment anxiety (t60=2.26; P=.03), compared to participants who are bereaved. There were pre-post within-group differences for both programs in the ITT sample, with significant reductions in grief (Cohen d=−0.90), depressive symptoms (Cohen d=−0.31), and centrality of the loss (Cohen d=−0.45). The same pattern was observed in the per-protocol sample, with the exception that anxiety symptoms also significantly diminished (Cohen d=−0.45). No difference was found in efficacy between the 2 programs (all P>.33). Participants (ITT sample) reported overall high levels of program satisfaction (mean 3.18, SD 0.54; over a maximum of 4). Effect stability was confirmed at the 6-month follow-up for all outcomes, with an improvement in self-concept clarity. Conclusions: The 2 grief-related WBIs were effective in reducing grief, depressive and anxiety symptoms for participants who are bereaved or separated. The analyses did not reveal any pre-post between-group differences, suggesting that the innovations brought to LIVIA 2.0 did not significantly affect the outcome. However, caution is warranted with the interpretation of the results given the limited power of the sample, which only allows the detection of medium effect sizes. Trial Registration: ClinicalTrials.gov NCT05219760; https://clinicaltrials.gov/study/NCT05219760 International Registered Report Identifier (IRRID): RR2-10.2196/39026 %M 39412869 %R 10.2196/57294 %U https://formative.jmir.org/2024/1/e57294 %U https://doi.org/10.2196/57294 %U http://www.ncbi.nlm.nih.gov/pubmed/39412869 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e48910 %T Perspectives of Children and Adolescents on Engaging With a Web-Based Mental Health Program: Focus Group Study %A Cahill,Christopher %A Connolly,Jennifer %A Appleton,Shelley %A White,Melanie Jade %K motivation %K demotivation %K external motivation %K internal motivation %K digital health interventions %K engagement %K internet interventions %K mental health %K eHealth %K youth %K children %K adolescents %D 2024 %7 15.10.2024 %9 %J JMIR Pediatr Parent %G English %X Background: Despite accessibility and clinical benefits, open access trials of self-guided digital health interventions (DHIs) for young people have been plagued by high drop-out rates, with some DHIs recording completion rates of less than 3%. Objective: The aim of this study was to explore how young people motivate themselves to complete an unpleasant task and to explore perceived motivators and demotivators for engaging with a DHI. Methods: In this qualitative research study, 30 children and adolescents aged between 7 and 17 years were recruited to participate in 7 focus groups conducted over a 3-month period. Focus group activities and discussions explored sources of motivation to complete tasks and engage in a hypothetical 6-week DHI for anxiety. Results: Children (aged 7-11 years) reported greater reliance on external motivators such as following parent instruction to complete unpleasant tasks, while adolescents (aged 12-17 years) reported greater internal motivation such as self-discipline. Program factors, such as engaging content, were the most commonly mentioned motivators for engaging with a DHI across both age groups. After that, internal sources of motivation were most commonly mentioned, such as perceived future benefits. External factors were the most commonly mentioned demotivators across all ages, with time commitment being the most frequently mentioned. Conclusions: The study’s findings have implications for enhancing adherence in future DHIs targeted to children and adolescents. Recommendations include the need for supportive parental involvement for children, while adolescents would likely benefit from mechanisms that promote autonomy, establish a supportive environment, and align with personal interests and values. Belief that a DHI will provide short-term benefits is important to both children and adolescents, as well as having confidence that future benefits will be realized. %R 10.2196/48910 %U https://pediatrics.jmir.org/2024/1/e48910 %U https://doi.org/10.2196/48910 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 9 %N %P e54370 %T Implementation of a Technology-Enabled Diabetes Self-Management Peer Coaching Intervention for Patients With Poorly Controlled Diabetes: Quasi-Experimental Case Study %A Arévalo Avalos,Marvyn R %A Patel,Ashwin %A Duru,Haci %A Shah,Sanjiv %A Rivera,Madeline %A Sorrentino,Eleanor %A Dy,Marika %A Sarkar,Urmimala %A Nguyen,Kim H %A Lyles,Courtney R %A Aguilera,Adrian %+ School of Social Welfare, University of California Berkeley, 205 Haviland Hall, #7400, Berkeley, CA, 94720, United States, 1 510 642 4341, aguila@berkeley.edu %K type 2 diabetes %K type 1 diabetes %K diabetes experiences %K eHealth %K mHealth %K peer coaching %K peer coach %K peer support %K self-management %K social determinants of health %K behavioral determinants of health %D 2024 %7 15.10.2024 %9 Original Paper %J JMIR Diabetes %G English %X Background: Patients with diabetes experience worse health outcomes and greater health care expenditure. Improving diabetes outcomes requires involved self-management. Peer coaching programs can help patients engage in self-management while addressing individual and structural barriers. These peer coaching programs can be scaled with digital platforms to efficiently connect patients with peer supporters who can help with diabetes self-management. Objective: This study aimed to evaluate the implementation of a technology-enabled peer coaching intervention to support diabetes self-management among patients with uncontrolled diabetes. Methods: MetroPlusHealth, a predominant Medicaid health maintenance organization based in New York City, partnered with Pyx Health to enroll 300 Medicaid patients with uncontrolled diabetes into its 6-month peer coaching intervention. Pyx Health peer coaches conduct at least 2 evidence-based and goal-oriented coaching sessions per month with their assigned patients. These sessions are focused on addressing both behavioral and social determinants of health (SDoH) with the goal of helping patients increase their diabetes self-management literacy, implement self-management behaviors, and reduce barriers to ongoing self-care. Data analyzed in this study included patient demographic data, clinical data (patient’s hemoglobin A1c [HbA1c]), and program implementation data including types of behavioral determinants of health and SDoH reported by patients and types of interventions used by peer coaches. Results: A total of 330 patients enrolled in the peer mentoring program and 2118 patients were considered to be on a waitlist group and used as a comparator. Patients who enrolled in the peer coaching program were older; more likely to be English speakers, female, and African American; and less likely to be White or Asian American or Pacific Islander than those in the waitlist condition, and had similar HbA1c laboratory results at baseline (intervention group 10.59 vs waitlist condition 10.62) Patients in the enrolled group had on average a –1.37 point reduction in the HbA1c score (n=70; pre: 10.99, post 9.62; P<.001), whereas patients in the waitlist group had a –0.16 reduction in the HbA1c score (n=207; pre 9.75, post 9.49; P<.001). Among a subsample of participants enrolled in the program with at least 2 HbA1c scores, we found that endorsement of emotional health issues (β=1.344; P=.04) and medication issues (β=1.36; P=.04) were significantly related to increases in HbA1c. Conclusions: This analysis of a technology-enabled 1-on-1 peer coaching program showed improved HbA1c levels for program participants relative to nonprogram participants. Results suggested participants with emotional stressors and medication management issues had worse outcomes and many preferred to connect through phone calls versus an app. These findings support the effectiveness of digital programs with multimodal approaches that include human support for improving diabetes self-management in a typically marginalized population with significant SDoH barriers. %M 39405529 %R 10.2196/54370 %U https://diabetes.jmir.org/2024/1/e54370 %U https://doi.org/10.2196/54370 %U http://www.ncbi.nlm.nih.gov/pubmed/39405529 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e57939 %T Feasibility and Acceptability of a Family-Based Telehealth Intervention for Families Impacted by the Child Welfare System: Formative Mixed Methods Evaluation %A Folk,Johanna B %A Valencia-Ayala,Cynthia %A Holloway,Evan D %A Anvar,Sarah %A Czopp,Alison %A Tolou-Shams,Marina %+ Department of Psychiatry and Behavioral Sciences, School of Medicine, University of California, San Francisco, 1001 Potrero Avenue, Building 5, 7M8, San Francisco, CA, 94110, United States, 1 4156029521, Johanna.folk@ucsf.edu %K family-based intervention %K affect management %K child welfare system %K telehealth %K formative evaluation %K trauma exposure %K substance misuse %K adverse childhood experiences %K trauma-informed care %K adolescent health %D 2024 %7 15.10.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Despite elevated rates of trauma exposure, substance misuse, mental health problems, and suicide, systems-impacted teens and their caregivers have limited access to empirically supported behavioral health services. Family-based interventions are the most effective for improving mental health, education, substance use, and delinquency outcomes, yet the familial and placement disruption that occurs during child welfare involvement can interfere with the delivery of family-based interventions. Objective: To address this gap in access to services, we adapted an in-person, empirically supported, family-based affect management intervention using a trauma-informed lens to be delivered via telehealth to families impacted by the child welfare system (Family Telehealth Project). We describe the intervention adaptation process and an open trial to evaluate its feasibility, acceptability, and impact. Methods: Adaptations to the in-person, family-based affect management intervention were conducted iteratively with input from youth, caregivers, and systems partners. Through focus groups and collaborative meetings with systems partners, a caregiver-only version of the intervention was also developed. An open trial of the intervention was conducted to assess family perspectives of its acceptability and feasibility and inform further refinements prior to a larger-scale evaluation. Participants included English-speaking families involved in the child welfare system in the past 12 months with teens (aged 12-18 years). Caregivers were eligible to participate either individually (caregivers of origin, kinship caregivers, or foster parents; n=7) or with their teen (caregiver of origin only; n=6 dyads). Participants completed session feedback forms and surveys at pretreatment, posttreatment, and 3-month posttreatment time points. Qualitative exit interviews were conducted with a subset of participants (12/19, 63%) to further understand their experiences with the intervention. Results: Session attendance was high, and both caregivers and teens reported high acceptability of clinicians and sessions on feedback forms. Families were comfortable with video technology, with very few (<5%) sessions having reported technology problems. Thematic analysis of exit interview transcripts indicated that families used effective communication and affect management skills taught during the intervention. Regarding challenges and barriers, some caregiver-only participants expressed a desire to have their teen also participate in the intervention. All interview participants reported that they would recommend the intervention to others and perceptions of the intervention were overwhelmingly positive. Quantitative surveys revealed differential responses to the intervention regarding affect management and communication. Conclusions: An open trial of the Family Telehealth Project, a skills-based telehealth intervention for families impacted by the child welfare system, suggests high levels of intervention feasibility and acceptability. Participants noted improvements in areas often hindered by the impacts of trauma and family separation: communication and affect management. Perceptions of the intervention were positive overall for both teens and caregivers. The Family Telehealth Project shows promise in addressing the gaps in behavioral health access for systems-impacted families. Trial Registration: ClinicalTrials.gov NCT04488523; https://clinicaltrials.gov/study/NCT04488523 %M 39405104 %R 10.2196/57939 %U https://formative.jmir.org/2024/1/e57939 %U https://doi.org/10.2196/57939 %U http://www.ncbi.nlm.nih.gov/pubmed/39405104 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e58356 %T Intervention for the Management of Neuropsychiatric Symptoms to Reduce Caregiver Stress: Protocol for the Mindful and Self-Compassion Care Intervention for Caregivers of Persons Living With Dementia %A Travis,Aniyah %A O’Donnell,Arden %A Giraldo-Santiago,Natalia %A Stone,Sarah M %A Torres,Daniel %A Adler,Shelley R %A Vranceanu,Ana-Maria %A Ritchie,Christine S %+ Harvard Medical School, 100 Cambridge Street, Suite 1600, Boston, MA, 02114, United States, 1 617 726 1382, csritchie@mgh.harvard.edu %K mindfulness %K caregiver %K self-compassion %K ADRD %K Alzheimer’s disease and related dementias %K mental health %D 2024 %7 11.10.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Stress related to Alzheimer disease and related dementias (ADRD) is common, particularly among those who care for persons with challenging behaviors and personality or mood changes. Mindfulness and self-compassion programs are efficacious for managing stress. The skills of mindfulness and self-compassion, however, must be integrated with behavioral management skills in order to effectively improve caregiver stress. Objective: In this study, we aimed to describe the development of the Mindful and Self-Compassionate Care (MASC) program, the first program that combines mindfulness and self-compassion with behavioral management skills to decrease caregiver stress, and its evaluation in the Supporting Our Caregivers in ADRD Learning (SOCIAL) study. Methods: Using the National Institutes of Health (NIH) stage model, we describe 3 phases of work encompassing NIH Stages 1A and 1B. In phase 1, we conducted 5 focus groups (N=28) of stressed individuals caring for persons with ADRD and challenging behaviors. Rapid data analysis informed the development of a 6-week online intervention. Phase 2 (NIH stage 1A) includes an open pilot (N>10) with optional exit interviews. Phase 3 (NIH stage 1B) is a feasibility randomized controlled trial of the intervention versus the Health Education Program control. Primary outcomes focus on feasibility with secondary outcomes encompassing acceptability, credibility, fidelity, and signals of preliminary efficacy. Phase 1 follows traditional recommendations for qualitative analyses (at the point of thematic saturation) which was achieved after 5 focus groups (N=28). For the phase 2 open pilot, up to 12 participants will be recruited. For the phase 3 feasibility study, recruitment of 80 caregivers will allow the assessment of feasibility benchmarks. Data for phase 1 included 5 focus groups. In phases 2 and 3, data collection will occur through REDCap (Research Electronic Data Capture; Vanderbilt University) surveys and an optional qualitative exit interview. Analyses will include hybrid inductive-deductive analyses for qualitative data and assessment of changes in our intervention targets and outcomes using t tests and correlation analyses. Results: In phase 1, caregivers reported interest in a brief, online stress management program. Participants held misconceptions about mindfulness and self-compassion, but after detailed explanation thoughts, these skills could be helpful when directly linked to implementation during caregiving routines. Phases 2 and 3 will be completed by the end of 2025. Conclusions: We describe the protocol for the Supporting Our Caregivers in ADRD Learning study, as well as the development and feasibility testing of the Mindful and Self-Compassionate Care intervention. Future work will include a fully powered efficacy-effectiveness randomized controlled trial. Trial Registration: ClinicalTrials NCT05847153; https://clinicaltrials.gov/study/NCT05847153; and ClinicalTrials.gov NCT06276023; https://clinicaltrials.gov/study/NCT06276023 International Registered Report Identifier (IRRID): DERR1-10.2196/58356 %M 39392675 %R 10.2196/58356 %U https://www.researchprotocols.org/2024/1/e58356 %U https://doi.org/10.2196/58356 %U http://www.ncbi.nlm.nih.gov/pubmed/39392675 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e51321 %T The Influence of Physical Activity and Diet Mobile Apps on Cardiovascular Disease Risk Factors: Meta-Review %A Bushey,Erica %A Wu,Yin %A Wright,Alexander %A Pescatello,Linda %+ University of Connecticut, 2098 Hillside Rd, Storrs, CT, United States, 1 860 486 0008, erica.bushey@uconn.edu %K physical activity %K diet %K mobile applications %K obesity %K hypertension %K dyslipidemia %K diabetes %K mobile phone %D 2024 %7 9.10.2024 %9 Review %J J Med Internet Res %G English %X Background: The literature on whether physical activity (PA) and PA and diet (PA+Diet) mobile apps improve cardiovascular disease (CVD) risk factors is promising. Objective: The aim of this meta-review is to provide an evidence synthesis of systematic reviews and meta-analyses examining the influence of PA and PA+Diet apps on the major CVD risk factors. Methods: We systematically searched 5 databases until January 12, 2022. Included systematic reviews and meta-analyses (1) reported the CVD risk factor outcomes of BMI, waist circumference, body weight, blood pressure (BP), hemoglobin A1c (HbA1c), fasting blood glucose, blood lipids, or PA; (2) enrolled healthy participants ≥18 years who may or may not have the metabolic syndrome, diabetes mellitus, or preexisting CVD risk factors; (3) reviewed PA or PA+Diet app interventions integrating behavioral change techniques (BCT) to deliver their information; and (4) had a nonapp control. Results: In total, 17 reviews (9 systematic reviews and 8 meta-analyses) published between 2012 and 2021 qualified. Participants were middle-aged, mostly women ranging in number from 10 to 62,219. Interventions lasted from 1 to 24 months, with the most common behavioral strategies being personalized feedback (n=8), self-monitoring (n=7), and goal setting (n=5). Of the PA app systematic reviews (N=4), the following CVD risk factors improved: body weight and BMI (n=2, 50%), BP (n=1, 25%), HbA1c (n=1, 25%), and blood lipids (n=1, 25%) decreased, while PA (n=4, 100%) increased. Of the PA+Diet app systematic reviews (N=5), the following CVD risk factors improved: body weight and BMI (n=3, 60%), BP (n=1, 20%), and HbA1c (n=3, 60%) decreased, while PA (n=3, 60%) increased. Of the PA app meta-analyses (N=1), the following CVD risk factors improved: body weight decreased (–0.73 kg, 95% CI –1.45 to –0.01; P=.05) and PA increased by 25 minutes/week (95% CI 0.58-1.68; P<.001), while BMI (–0.09 kg/m2, 95% CI –0.29 to 0.10; P=.35) and waist circumference (–1.92 cm, 95% CI –3.94 to 0.09; P=.06) tended to decrease. Of the PA+Diet app meta-analyses (n=4), the following CVD risk factors improved: body weight (n=4, 100%; from –1.79 kg 95% CI –3.17 to –0.41; P=.01 to –2.80 kg 95% CI –4.54 to –1.06, P=.002), BMI (n=1, 25%; –0.64 kg/m2, 95% CI –1.09 to –0.18; P=.01), waist circumference (n=1, 25%; –2.46 cm, 95% CI –4.56 to –0.36; P=.02), systolic/diastolic BP (n=1, 25%; –4.22/–2.87 mm Hg, 95% CI –6.54 to –1.91/ –4.44 to –1.29; P<.01), and HbA1c (n=1, 25%; –0.43%, 95% CI –0.68 to –0.19; P<.001) decreased. Conclusions: PA and PA+Diet apps appear to be most consistent in improving PA and anthropometric measures with favorable but less consistent effects on other CVD risk factors. Future studies are needed that directly compare and better quantify the effects of PA and PA+Diet apps on CVD risk factors. Trial Registration: PROSPERO CRD42023392359; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=392359 %M 39382958 %R 10.2196/51321 %U https://www.jmir.org/2024/1/e51321 %U https://doi.org/10.2196/51321 %U http://www.ncbi.nlm.nih.gov/pubmed/39382958 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e56480 %T A Behavioral Change–Based Mobile Intervention for Promoting Regular Physical Activity in Medical Rehabilitation Maintenance of Patients With Coronary Artery Disease: Controlled Trial %A Waranski,Melina %A Garbsch,René %A Kotewitsch,Mona %A Teschler,Marc %A Schmitz,Boris %A Mooren,Frank C %+ Department of Rehabilitation Sciences, Faculty of Health, University of Witten/Herdecke, Alfred-Herrhausen-Straße 50, Witten, 58455, Germany, 49 23339888156, boris.schmitz@uni-wh.de %K rehabilitation %K eHealth %K mobile health %K mHealth %K telemedicine %K cardiovascular disease %K behavioral change %K mobile phone %D 2024 %7 8.10.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Cardiac rehabilitation is known to reduce coronary artery disease (CAD) severity and symptoms, but adoption of a healthy postrehabilitation lifestyle remains challenging. Innovative eHealth solutions could help, but behavioral change–based eHealth maintenance programs for patients with CAD are scarce. RehaPlus+ aims to improve postrehabilitation outcomes with a personalized eHealth intervention built on behavioral change concepts emphasizing healthy lifestyle changes, especially regular physical activity (PA). Objective: This study aims to evaluate the effectiveness of the personalized eHealth program RehaPlus+ for promoting regular PA against usual care. Methods: A total of 169 patients with CAD who had undergone stent implantation or bypass surgery were recruited after completing center-based phase II rehabilitation. They were then divided, without blinding, into 2 groups using a quasi-experimental approach: a case manager–assisted 24-week eHealth program (RehaPlus+; n=84) and a conventional physician-assisted outpatient program (usual care; n=85). The study was designed as a noninferiority trial. RehaPlus+ participants received motivational messages twice weekly for 6 months, and the usual care group engaged in a 6-month outpatient program (twenty-four 90-minute strength and endurance training sessions). The primary outcomes, evaluated using the self-assessed Bewegungs- und Sportaktivität questionnaire, were regular PA (≥150 min/wk) and weekly activities of daily living (ADLs) 6 months after rehabilitation. Secondary outcomes involved PA during work and floors climbed weekly (measured by Bewegungs- und Sportaktivität questionnaire), psychological well-being (assessed by the 5-item World Health Organization Well-Being Index), cardiac self-efficacy, health-related quality of life (measured by the 36-Item Short Form Survey), and work ability (using the Work Ability Index). Results: Data of 105 patients (RehaPlus+: n=44, 41.9%; usual care: n=61, 58.1%; male patients: n=80, 76.2%; female patients: n=25, 23.8%; mean age 56.0, SD 7.3 years) were available at the 6-month follow-up. At 6 months after discharge from phase II cardiac rehabilitation, the RehaPlus+ group exhibited 182 (SD 208) minutes per week of PA and the usual care group exhibited 119 (SD 175) minutes per week of PA (P=.15), with no interaction effect (P=.12). The RehaPlus+ group showed an ADL level of 443 (SD 538) minutes per week compared to the usual care group with 308 (SD 412) minutes per week at the 6-month follow-up, with no interaction effect (P=.84). The differences observed in PA and ADL levels between the RehaPlus+ and usual care groups were within the predefined 1-sided noninferiority margin, indicating that the RehaPlus+ intervention is not inferior to usual care based on these outcomes. There were no differences between the groups for all secondary outcomes (P>.05). Conclusions: RehaPlus+ is not inferior to the usual care program, as both groups improved PA and ADLs to a similar extent. These findings emphasize the potential of eHealth interventions to assist in maintaining healthy lifestyles after rehabilitation. Trial Registration: ClinicalTrials.gov NCT06162793; https://clinicaltrials.gov/study/NCT06162793 %M 39378432 %R 10.2196/56480 %U https://www.jmir.org/2024/1/e56480 %U https://doi.org/10.2196/56480 %U http://www.ncbi.nlm.nih.gov/pubmed/39378432 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e56674 %T Comparison of Analgesia Methods Through a Web Platform in Patients Undergoing Thoracic Surgery: Pilot Design, Implementation, and Validation Study %A Trò,Rosella %A Orecchia,Angelica %A Disma,Nicola %A Uva,Paolo %A Cavanna,Roberto %A Zanardi,Nicolò %A Torre,Michele %A Fato,Marco Massimo %+ Department of Informatics, Bioengineering, Robotics and System Engineering, University of Genoa, Via all'Opera Pia 13, Genoa, 16145, Italy, 39 3408716911, rosella.tro@edu.unige.it %K pectus excavatum %K pain assessment %K web platform %K health care informatics %D 2024 %7 8.10.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Pain management is a vital and essential part of postoperative pectus excavatum (PE) care. Given the lack of an international consensus on guidelines for postoperative handling and evaluation, further research is necessary to compare the efficacy of existing pain management methods regarding pain relief, side effects, and long-term outcomes. In this context, the use of eHealth solutions for data mining can enhance data collection efficiency, reduce errors, and improve patient engagement. However, these digital health care frameworks are currently underused in the context of pain management for PE. Objective: This research is part of the broader Cryoanalgesia for Pain Management After Pectus Excavatum Repair (COPPER) study conducted by Giannina Gaslini Children’s Hospital to address postoperative pain and recovery in PE patients treated with either standard thoracic epidural analgesia or cryoanalgesia, which is considered its innovative alternative approach. Specifically, this work is aimed at introducing a valuable tool for a comprehensive and quantitative comparison of the 2 analgesia strategies. The tool is a web and mobile app designed to facilitate data collection, management, and analysis of clinical data for pain assessment. Methods: The adopted approach involves a careful design based on clinician input, resulting in an intuitive app structure with 3 main screens. Digital surveys are borrowed from paper surveys, including medical history and preoperative, postoperative, and follow-up evaluations. XTENS 2.0 was used to manage the data, and Ionic facilitated cross-platform app development, ensuring secure and adaptable data handling. Results: Preliminary analysis on a pilot cohort of 72 patients (36 treated with standard therapy and 36 treated with cryoanalgesia) indicated successful patient enrollment and balanced representation across treatment groups and genders. Notably, hospital stay was significantly shorter with cryoanalgesia than with standard therapy (Mann-Whitney-Wilcoxon 2-sided test with Bonferroni correction; P<.001; U statistic=287.5), validating its treatment efficacy. Conclusions: This work is a step toward modernizing health care through digital transformation and patient-centered models. The app shows promise in streamlined data collection and patient engagement, although improvements in multilingual support, data validation, and incentivization of questionnaire completion are warranted. Overall, this study highlights the potential of digital health solutions in revolutionizing health care practices, fostering patient involvement, and improving care quality. %M 39378419 %R 10.2196/56674 %U https://formative.jmir.org/2024/1/e56674 %U https://doi.org/10.2196/56674 %U http://www.ncbi.nlm.nih.gov/pubmed/39378419 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e60834 %T Effectiveness of a Digital Health Intervention Leveraging Reinforcement Learning: Results From the Diabetes and Mental Health Adaptive Notification Tracking and Evaluation (DIAMANTE) Randomized Clinical Trial %A Aguilera,Adrian %A Arévalo Avalos,Marvyn %A Xu,Jing %A Chakraborty,Bibhas %A Figueroa,Caroline %A Garcia,Faviola %A Rosales,Karina %A Hernandez-Ramos,Rosa %A Karr,Chris %A Williams,Joseph %A Ochoa-Frongia,Lisa %A Sarkar,Urmimala %A Yom-Tov,Elad %A Lyles,Courtney %+ School of Social Welfare, University of California Berkeley, 205 Haviland Hall, Berkeley, CA, 94709, United States, 1 510 642 8564, aguila@berkeley.edu %K digital health %K physical activity %K mobile phone %K text messages %K SMS %K steps %K walking %K diabetes %K depression %K reinforcement learning %K exercise %K machine learning %D 2024 %7 8.10.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital and mobile health interventions using personalization via reinforcement learning algorithms have the potential to reach large number of people to support physical activity and help manage diabetes and depression in daily life. Objective: The Diabetes and Mental Health Adaptive Notification and Tracking Evaluation (DIAMANTE) study tested whether a digital physical activity intervention using personalized text messaging via reinforcement learning algorithms could increase step counts in a diverse, multilingual sample of people with diabetes and depression symptoms. Methods: From January 2020 to June 2022, participants were recruited from 4 San Francisco, California–based public primary care clinics and through web-based platforms to participate in the 24-week randomized controlled trial. Eligibility criteria included English or Spanish language preference and a documented diagnosis of diabetes and elevated depression symptoms. The trial had 3 arms: a Control group receiving a weekly mood monitoring message, a Random messaging group receiving randomly selected feedback and motivational text messages daily, and an Adaptive messaging group receiving text messages selected by a reinforcement learning algorithm daily. Randomization was performed with a 1:1:1 allocation. The primary outcome, changes in daily step counts, was passively collected via a mobile app. The primary analysis assessed changes in daily step count using a linear mixed-effects model. An a priori subanalysis compared the primary step count outcome within recruitment samples. Results: In total, 168 participants were analyzed, including those with 24% (40/168) Spanish language preference and 37.5% (63/168) from clinic-based recruitment. The results of the linear mixed-effects model indicated that participants in the Adaptive arm cumulatively gained an average of 3.6 steps each day (95% CI 2.45-4.78; P<.001) over the 24-week intervention (average of 608 total steps), whereas both the Control and Random arm participants had significantly decreased rates of change. Postintervention estimates suggest that participants in the Adaptive messaging arm showed a significant step count increase of 19% (606/3197; P<.001), in contrast to 1.6% (59/3698) and 3.9% (136/3480) step count increase in the Random and Control arms, respectively. Intervention effectiveness differences were observed between participants recruited from the San Francisco clinics and those recruited via web-based platforms, with the significant step count trend persisting across both samples for participants in the Adaptive group. Conclusions: Our study supports the use of reinforcement learning algorithms for personalizing text messaging interventions to increase physical activity in a diverse sample of people with diabetes and depression. It is the first to test this approach in a large, diverse, and multilingual sample. Trial Registration: ClinicalTrials.gov NCT03490253; https://clinicaltrials.gov/study/NCT03490253 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2019-034723 %M 39378080 %R 10.2196/60834 %U https://www.jmir.org/2024/1/e60834 %U https://doi.org/10.2196/60834 %U http://www.ncbi.nlm.nih.gov/pubmed/39378080 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e55726 %T The Feasibility and Acceptability of Using a Digital Conversational Agent (Chatbot) for Delivering Parenting Interventions: Systematic Review %A Klapow,Max C %A Rosenblatt,Andrew %A Lachman,Jamie %A Gardner,Frances %+ Department of Experimental Psychology, University of Oxford, Anna Watts Building, Woodstock Road, Oxford, OX2 6GG, United Kingdom, 44 01865 271444, maxwell.klapow@psy.ox.ac.uk %K chatbot %K parenting intervention %K feasibility %K acceptability %K systematic review %K implementation %D 2024 %7 7.10.2024 %9 Review %J JMIR Pediatr Parent %G English %X Background: Parenting interventions are crucial for promoting family well-being, reducing violence against children, and improving child development outcomes; however, scaling these programs remains a challenge. Prior reviews have characterized the feasibility, acceptability, and effectiveness of other more robust forms of digital parenting interventions (eg, via the web, mobile apps, and videoconferencing). Recently, chatbot technology has emerged as a possible mode for adapting and delivering parenting programs to larger populations (eg, Parenting for Lifelong Health, Incredible Years, and Triple P Parenting). Objective: This study aims to review the evidence of using chatbots to deliver parenting interventions and assess the feasibility of implementation, acceptability of these interventions, and preliminary outcomes. Methods: This review conducted a comprehensive search of databases, including Web of Science, MEDLINE, Scopus, ProQuest, and Cochrane Central Register of Controlled Trials. Cochrane Handbook for Systematic Review of Interventions and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used to conduct the search. Eligible studies targeted parents of children aged 0 to 18 years; used chatbots via digital platforms, such as the internet, mobile apps, or SMS text messaging; and targeted improving family well-being through parenting. Implementation measures, acceptability, and any reported preliminary measures of effectiveness were included. Results: Of the 1766 initial results, 10 studies met the inclusion criteria. The included studies, primarily conducted in high-income countries (8/10, 80%), demonstrated a high mean retention rate (72.8%) and reported high acceptability (10/10, 100%). However, significant heterogeneity in interventions, measurement methods, and study quality necessitate cautious interpretation. Reporting bias, lack of clarity in the operationalization of engagement measures, and platform limitations were identified as limiting factors in interpreting findings. Conclusions: This is the first study to review the implementation feasibility and acceptability of chatbots for delivering parenting programs. While preliminary evidence suggests that chatbots can be used to deliver parenting programs, further research, standardization of reporting, and scaling up of effectiveness testing are critical to harness the full benefits of chatbots for promoting family well-being. %M 39374516 %R 10.2196/55726 %U https://pediatrics.jmir.org/2024/1/e55726 %U https://doi.org/10.2196/55726 %U http://www.ncbi.nlm.nih.gov/pubmed/39374516 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e49505 %T The Effectiveness of a Digital Mental Fitness Program (Positive Intelligence) on Perceived Stress, Self-Compassion, and Ruminative Thinking of Occupational Therapy Undergraduate Students: Longitudinal Study %A Puah,Shermain %A Pua,Ching Yee %A Shi,Jing %A Lim,Sok Mui %+ SIT Teaching and Learning Academy (STLA), Singapore Institute of Technology, 1 Punggol Coast Road, Singapore, 828608, Singapore, 65 6592 7637, shermain.puah@singaporetech.edu.sg %K mental health %K students %K digital wellness %K mobile health (mHealth) %K perceived stress %K self-compassion %K rumination %D 2024 %7 7.10.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Health care students often endure numerous stressors throughout their undergraduate education that can have lasting negative effects on their mental well-being. Positive Intelligence (PQ) is a digital mental fitness program designed to enhance self-mastery and help individuals reach their potential by strengthening various “mental muscles.” Objective: This study aims to evaluate the effectiveness of a 6-week app-delivered PQ program in reducing perceived stress, increasing self-compassion, and decreasing rumination tendencies among health care undergraduates. We hypothesized that students would show reductions in perceived stress, increases in self-compassion, and decreases in rumination tendencies by the end of the PQ program, compared with their preprogram scores. We adopted an exploratory approach for the 5-month follow-up due to the limited research consensus on the sustained effects of app-based programs over varying periods. Methods: The PQ program includes weekly hour-long videos, weekly group meetings, and daily 15-minute app-guided practices. Participants were first-year students from the occupational therapy program at a university in Singapore. Participants completed surveys measuring self-compassion, perceived stress, and rumination levels before and after the PQ program, and again at a 5-month follow-up. Data were analyzed using repeated measures ANOVA to assess differences across the pretest, immediate posttest, and follow-up posttest. Results: Out of 87 students enrolled in the study, the final sample consisted of 64 students (n=47, 73%, female; mean age 23 years, SD 5.06 years) with complete data. At the end of the 6 weeks, students exhibited significant increases in self-compassion (before the intervention: mean 3.07, SD 0.35; after the intervention: mean 3.34, SD 0.35; P<.001) and reductions in rumination tendencies (before the intervention: mean 3.57, SD 0.40; after the intervention: mean 3.27, SD 0.34; P<.001). However, no significant change in perceived stress levels was observed (before the intervention: 2.99, SD 0.14; after the intervention: mean 2.97, SD 0.16; P=.50). These effects were not influenced by the daily app-based practice of PQ exercises, and there were no sustained effects on self-compassion (mean 3.17, SD 0.27; P=.09) or rumination tendencies (mean 3.42, SD 0.38; P=.06) at the 5-month follow-up. Additionally, there was a significant increase in perceived stress at follow-up (mean 3.17, SD 0.21; P<.001) compared with pre- and postintervention levels. Conclusions: The PQ program did not directly alter stress perceptions but may have reframed students’ automatic negative thought processes, increased their awareness of self-sabotaging behaviors, and enhanced their self-compassion while reducing ruminative thinking. These findings highlight the importance of self-awareness for students’ well-being. Students can benefit from practices such as mindfulness and peer discussions to enhance self-compassion and reduce rumination. Educators trained in the PQ program can foster a supportive environment that encourages self-compassion, challenges negative self-talk, and helps students manage stress. %M 39374067 %R 10.2196/49505 %U https://www.jmir.org/2024/1/e49505 %U https://doi.org/10.2196/49505 %U http://www.ncbi.nlm.nih.gov/pubmed/39374067 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e63858 %T Supporting Weight Loss Among Parents of Children With a Disability: Lessons Learned From a Single-Arm Pilot Study %A Wisniewski,Payson %A Depuy,Julia %A Kim,Cassandra %A Garrison,Olivia %A Jerome,Gerald J %+ Department of Kinesiology, Towson University, 8000 York Road, Towson, MD, 21252, United States, 1 4107045283, gjerome@towson.edu %K weight loss %K obesity %K disability %K parent %K family %K child %K weight loss intervention %D 2024 %7 7.10.2024 %9 Research Letter %J JMIR Form Res %G English %X This study assessed weight change in the parents of children with disabilities following a 12-week, remotely delivered weight loss program focused on lifestyle modifications and found a significant median weight reduction of 3 kg from baseline to week 12. %M 39374058 %R 10.2196/63858 %U https://formative.jmir.org/2024/1/e63858 %U https://doi.org/10.2196/63858 %U http://www.ncbi.nlm.nih.gov/pubmed/39374058 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e50847 %T Internet-Based Supportive Interventions for Family Caregivers of People With Dementia: Randomized Controlled Trial %A Xie,Yanhong %A Shen,Shanshan %A Liu,Caixia %A Hong,Hong %A Guan,Huilan %A Zhang,Jingmei %A Yu,Wanqi %K dementia %K family caregiver %K web-based training %K care burden %K care ability %K caregivers %K carer %K caregiving %K informal care %K RCT %K controlled trial %K randomized %K gerontology %K geriatric %K older adult %K elder %K elderly %K older person %K older people %K ageing %K aging %K dementia care %K randomized controlled trial %K internet-based training %D 2024 %7 4.10.2024 %9 %J JMIR Aging %G English %X Background: As dementia progresses, patients exhibit various psychological and behavioral symptoms, imposing a significant burden on families and society, including behavioral and psychological symptoms of dementia. However, caregivers lack professional care knowledge and skills, making it difficult for them to effectively cope with the diverse challenges of caregiving. Therefore, it is necessary to provide caregivers with professional knowledge and skills guidance. Objective: This study aimed to analyze the impact of internet-based training on behavioral and psychological symptoms of dementia in patients, and explore how this training model affects the caregiving abilities and caregiving burden of the family caregivers of patients with dementia. Methods: Using a consecutive enrollment method, the Department of Geriatrics at Zhejiang Hospital (Zhejiang, China) recruited 72 informal caregivers of patients with dementia. These caregivers were randomly divided into an intervention group and a control group, with 36 participants in each group. The intervention group underwent caregiver skill training via a web-based platform, whereas the control group initially received face-to-face follow-up guidance and was subsequently offered web-based training after 6 months. To assess the effectiveness of the intervention program, we used the Neuropsychiatric Inventory Questionnaire (NPI-Q), the Chinese version of the Zarit Burden Interview (CZBI), and the Sense of Competence in Dementia Care Staff Scale (SCIDS) for evaluations conducted before the intervention, 3 months after the intervention, and 6 months after the intervention. Results: Between July 2019 and December 2020, a total of 66 patients successfully completed the intervention and follow-up. After 6 months of intervention, the NPI-Q score of the intervention group was 3.18 (SD 3.81), the CZBI score was 10.97 (SD 5.43), and the SCIDS score was 71.88 (SD 4.78). The NPI-Q score of the control group was 8.09 (SD 8.52), the CZBI score was 30.30 (SD 13.05), and the SCIDS score was 50.12 (SD 9.10). There were statistically significant differences in NPI-Q (P=.004), CZBI (P<.001), and SCIDS scores (P<.001) between the intervention group and the control group. Repeated measures analysis of variance showed that compared with before the intervention, there were statistically significant differences in CZBI (P<.001) and SCIDS (P<.001) scores 3 months after the intervention, while the difference in NPI-Q (P=.11) scores was not significant. The total scores of NPI-Q (P<.001), CZBI (P<.001), and SCIDS (P<.001) were significantly improved 6 months after the intervention. In addition, the results of the covariance analysis showed that after excluding the time effect, the web-based training intervention significantly reduced the NPI-Q score (−2.79, 95% CI −4.38 to −1.19; P<.001) of patients with dementia and the CZBI score (−13.52, 95% CI −15.87 to −11.16; P<.001) of caregivers, while increasing the SCIDS score (12.24, 95% CI 9.02-15.47; P<.001). Conclusions: Internet-based training could significantly reduce the level of behavioral symptoms in older patients with dementia and alleviate the burden on caregivers, enhancing their caregiving abilities. Our results confirmed the effectiveness and feasibility of web-based training, which was of great significance in providing caregiving knowledge training for informal caregivers of persons with dementia. Trial Registration: Chinese Clinical Trial Registry ChiCTR2200057858; https://www.chictr.org.cn/showproj.html?proj=136442 %R 10.2196/50847 %U https://aging.jmir.org/2024/1/e50847 %U https://doi.org/10.2196/50847 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e54405 %T Considering User Experience and Behavioral Approaches in the Design of mHealth Interventions for Atrial Fibrillation: Systematic Review %A Suresh Kumar,Sagar %A Connolly,Patricia %A Maier,Anja %+ Department of Design, Manufacturing and Engineering Management (DMEM), University of Strathclyde, James Weir Building, 75 Montrose Street, Glasgow, G1 1XJ, United Kingdom, 44 1415482091, sagar.suresh-kumar@strath.ac.uk %K atrial fibrillation %K wearable devices %K lifestyle modification %K user experience %K design for behavior change %K systems thinking %K cardiac disease %K stroke %K heart disease %K complication %K mobile health %K systematic review %K usability %K mHealth %K intervention %D 2024 %7 4.10.2024 %9 Review %J J Med Internet Res %G English %X Background: Atrial fibrillation (AF) is a leading chronic cardiac disease associated with an increased risk of stroke, cardiac complications, and general mortality. Mobile health (mHealth) interventions, including wearable devices and apps, can aid in the detection, screening, and management of AF to improve patient outcomes. The inclusion of approaches that consider user experiences and behavior in the design of health care interventions can increase the usability of mHealth interventions, and hence, hopefully, yield an increase in positive outcomes in the lives of users. Objective: This study aims to show how research has considered user experiences and behavioral approaches in designing mHealth interventions for AF detection, screening, and management; the phases of designing complex interventions from the UK Medical Research Council (MRC) were referenced: namely, identification, development, feasibility, evaluation, and implementation. Methods: Studies published until September 7, 2022, that examined user experiences and behavioral approaches associated with mHealth interventions in the context of AF were extracted from multiple databases. The PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines were used. Results: A total of 2219 records were extracted, with only 55 records reporting on usability, user experiences, or behavioral approaches more widely for designing mHealth interventions in the context of AF. When mapping the studies onto the phases of the UK MRC’s guidance for developing and evaluating complex interventions, the following was found: in the identification phase, there were significant differences between the needs of patients and health care workers. In the development phase, user perspectives guided the iterative development of apps, interfaces, and intervention protocols in 4 studies. Most studies (43/55, 78%) assessed the usability of interventions in the feasibility phase as an outcome, although the data collection tools were not designed together with users and stakeholders. Studies that examined the evaluation and implementation phase entailed reporting on challenges in user participation, acceptance, and workflows that could not be captured by studies in the previous phases. To realize the envisaged human behavior intended through treatment, review results highlight the scant inclusion of behavior change approaches for mHealth interventions across multiple levels of sociotechnical health care systems. While interventions at the level of the individual (micro) and the level of communities (meso) were found in the studies reviewed, no studies were found intervening at societal levels (macro). Studies also failed to consider the temporal variation of user goals and feedback in the design of long-term behavioral interventions. Conclusions: In this systematic review, we proposed 2 contributions: first, mapping studies to different phases of the MRC framework for developing and evaluating complex interventions, and second, mapping behavioral approaches to different levels of health care systems. Finally, we discuss the wider implications of our results in guiding future mHealth research. %M 39365991 %R 10.2196/54405 %U https://www.jmir.org/2024/1/e54405 %U https://doi.org/10.2196/54405 %U http://www.ncbi.nlm.nih.gov/pubmed/39365991 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e45461 %T Impact of a Self-Autonomous Evaluation Station and Personalized Training Algorithm on Quality of Life and Physical Capacities in Sedentary Adults: Randomized Controlled Trial %A Le Mat,Yann %A Casali,Corentin %A Le Mat,Franck %A Féasson,Léonard %A Foschia,Clément %A Géry,Mathias %A Rossi,Jérémy %A Millet,Guillaume Y %+ Université Jean Monnet Saint-Etienne, Lyon 1, Université Savoie Mont-Blanc, Laboratoire Interuniversitaire de Biologie de la Motricité, F-42023, 10 rue de Tréfilerie, Saint Etienne, 42100, France, 33 0477421875, yann.lemat@univ-st-etienne.fr %K physical activity %K sedentary behavior %K quality of life %K mobile health %K health-related interventions %K mobile app %K mobile phone %D 2024 %7 4.10.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Physical inactivity is a major risk factor for noncommunicable diseases and a leading cause of premature death. The World Health Organization (WHO) recommends at least 150 minutes of moderate intensity physical activity (PA) weekly, regardless of age, gender, or personal habits. However, in both sports performance and clinical settings, personalized training (PT) regimens have shown superior efficacy over general guidelines. Objective: We hypothesized that an automatic PT program, informed by initial physical evaluations, would increase overall quality of life, quality of sleep, and physical capabilities and reduce fatigue and depression compared with adherence to WHO recommendations. Methods: This 5-month, randomized, single-blinded controlled trial involved 112 sedentary or minimally active participants, divided randomly into PT and free training (FT) groups. Physical capabilities and subjective measures such as quality of life, sleep, depression, and fatigue were evaluated for both groups. After 1 month, both groups were asked to perform 150 minutes of PA per week for 4 months; the PT group could either follow a “virtual coach” on a mobile app to follow some personalized PA or do what they would like, while the FT group was to follow the general PA recommendations of the WHO. Results: We did not find any group×time interaction for PA duration or intensity, physical qualities, and subjective measures. However, considering both groups together, there was a significant pretest and posttest time effect for duration of PA (18.2 vs 24.5 min/d of PA; P<.001), intensity (2.36 vs 3.11; P<.001), and workload (46.8 vs 80.5; P<.001). Almost all physical qualities were increased pretest and posttest (ie, estimated VO2max 26.8 vs 29 mL min–1 kg–1; P<.001; flexibility 25.9 vs 26.9 cm; P=.049; lower limb isometric forces 328 vs 347 N m; P=.002; reaction time 0.680 vs 0.633 s; P<.001; power output on cyclo-ergometer 7.63 vs 7.82 W; P<.003; and balance for the left and right leg 215 vs 163 mm2; P<.003 and 186 vs 162 mm2; P=.048, respectively). Finally, still considering the PT and FT groups together, there were significant pretest to posttest improvements in the mental component of quality of life using the 12-item Short Form Health Survey (41.9 vs 46.0; P<.006), well-being using the Warwick-Edinburgh Mental Well-Being Scale (48.3 vs 51.7; P<.002), depression using the Center for Epidemiologic Studies Depression Scale (15.5 vs 11.5; P=.02), and fatigue using the Functional Assessment of Chronic Illness Therapy–Fatigue (37.1 vs 39.5; P=.048). Conclusions: The individualized training was not more effective than the general recommendations. A slight increase in PA (from 18 to 24 min/d) in sedentary or poorly active people is enough for a significant increase in physical capabilities and a significant improvement in quality of life, well-being, depression, and fatigue. Trial Registration: ClinicalTrials.gov NCT04998266; https://clinicaltrials.gov/study/NCT04998266 %M 39365990 %R 10.2196/45461 %U https://formative.jmir.org/2024/1/e45461 %U https://doi.org/10.2196/45461 %U http://www.ncbi.nlm.nih.gov/pubmed/39365990 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e58380 %T Enhancing Patient Safety Through an Integrated Internet of Things Patient Care System: Large Quasi-Experimental Study on Fall Prevention %A Wen,Ming-Huan %A Chen,Po-Yin %A Lin,Shirling %A Lien,Ching-Wen %A Tu,Sheng-Hsiang %A Chueh,Ching-Yi %A Wu,Ying-Fang %A Tan Cheng Kian,Kelvin %A Hsu,Yeh-Liang %A Bai,Dorothy %+ School of Gerontology and Long-Term Care, College of Nursing, Taipei Medical University, No.250, Wuxing Street, Xinyi District, Taipei, 110, Taiwan, 886 227361661 ext 6332, dbai@tmu.edu.tw %K patient safety %K falls %K fall prevention %K fall risk %K sensors %K Internet of Things %K bed-exit alert %K motion-sensing mattress system %K care quality %K quality improvement %K ubiquitous health %K mHealth %D 2024 %7 3.10.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: The challenge of preventing in-patient falls remains one of the most critical concerns in health care. Objective: This study aims to investigate the effect of an integrated Internet of Things (IoT) smart patient care system on fall prevention. Methods: A quasi-experimental study design is used. The smart patient care system is an integrated IoT system combining a motion-sensing mattress for bed-exit detection, specifying different types of patient calls, integrating a health care staff scheduling system, and allowing health care staff to receive and respond to alarms via mobile devices. Unadjusted and adjusted logistic regression models were used to investigate the relationship between the use of the IoT system and bedside falls compared with a traditional patient care system. Results: In total, 1300 patients were recruited from a medical center in Taiwan. The IoT patient care system detected an average of 13.5 potential falls per day without any false alarms, whereas the traditional system issued about 11 bed-exit alarms daily, with approximately 4 being false, effectively identifying 7 potential falls. The bedside fall incidence during hospitalization was 1.2% (n=8) in the traditional patient care system ward and 0.1% (n=1) in the smart ward. We found that the likelihood of bedside falls in wards with the IoT system was reduced by 88% (odds ratio 0.12, 95% CI 0.01-0.97; P=.047). Conclusions: The integrated IoT smart patient care system might prevent falls by assisting health care staff with efficient and resilient responses to bed-exit detection. Future product development and research are recommended to introduce IoT into patient care systems combining bed-exit alerts to prevent inpatient falls and address challenges in patient safety. %M 39361417 %R 10.2196/58380 %U https://www.jmir.org/2024/1/e58380 %U https://doi.org/10.2196/58380 %U http://www.ncbi.nlm.nih.gov/pubmed/39361417 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e53786 %T Predictors of Participation in a Perinatal Text Message Screening Protocol for Maternal Depression and Anxiety: Prospective Cohort Study %A Barnwell,Julia %A Hénault Robert,Cindy %A Nguyen,Tuong-Vi %A Davis,Kelsey P %A Gratton,Chloé %A Elgbeili,Guillaume %A Pham,Hung %A Meaney,Michael J %A Montreuil,Tina C %A O'Donnell,Kieran J %+ Yale Child Study Center, Yale School of Medicine, 230 South Frontage Road, New Haven, CT, 06520, United States, 1 203 785 2540, kieran.odonnell@yale.edu %K perinatal mental health %K digital screening %K maternal depression %K maternal anxiety %K text messaging %K mHealth %K mobile health %K pregnancy %K mobile phone %D 2024 %7 3.10.2024 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Universal screening for depression and anxiety in pregnancy has been recommended by several leading medical organizations, but the implementation of such screening protocols may overburden health care systems lacking relevant resources. Text message screening may provide a low-cost, accessible alternative to in-person screening assessments. However, it is critical to understand who is likely to participate in text message–based screening protocols before such approaches can be implemented at the population level. Objective: This study aimed to examine sources of selection bias in a texting–based screening protocol that assessed symptoms of depression and anxiety across pregnancy and into the postpartum period. Methods: Participants from the Montreal Antenatal Well-Being Study (n=1130) provided detailed sociodemographic information and completed questionnaires assessing symptoms of depression (Edinburgh Postnatal Depression Scale [EPDS]) and anxiety (State component of the State-Trait Anxiety Inventory [STAI-S]) at baseline between 8 and 20 weeks of gestation (mean 14.5, SD 3.8 weeks of gestation). Brief screening questionnaires, more suitable for delivery via text message, assessing depression (Whooley Questions) and anxiety symptoms (Generalized Anxiety Disorder 2-Item questionnaire) were also collected at baseline and then via text message at 14-day intervals. Two-tailed t tests and Fisher tests were used to identify maternal characteristics that differed between participants who responded to the text message screening questions and those who did not. Hurdle regression models were used to test if individuals with a greater burden of depression and anxiety at baseline responded to fewer text messages across the study period. Results: Participants who responded to the text messages (n=933) were more likely than nonrespondents (n=114) to self-identify as White (587/907, 64.7% vs 39/96, 40.6%; P<.001), report higher educational attainment (postgraduate: 268/909, 29.5% vs 15/94, 16%; P=.005), and report higher income levels (CAD $150,000 [a currency exchange rate of CAD $1=US $0.76 is applicable] or more: 176/832, 21.2% vs 10/84, 11.9%; P<.001). There were no significant differences in symptoms of depression and anxiety between the 2 groups at baseline or postpartum. However, baseline depression (EPDS) or anxiety (STAI-S) symptoms did predict the total number of text message time points answered by participants, corresponding to a decrease of 1% (eβ=0.99; P<.001) and 0.3% (eβ=0.997; P<.001) in the number of text message time points answered per point increase in EPDS or STAI-S score, respectively. Conclusions: Findings from this study highlight the feasibility of text message–based screening protocols with high participation rates. However, our findings also highlight how screening and service delivery via digital technology could exacerbate disparities in mental health between certain patient groups. %M 39361419 %R 10.2196/53786 %U https://pediatrics.jmir.org/2024/1/e53786 %U https://doi.org/10.2196/53786 %U http://www.ncbi.nlm.nih.gov/pubmed/39361419 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e55883 %T Efficacy of WeChat-Based Digital Intervention Versus Metformin in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial %A Dilimulati,Diliqingna %A Shao,Xiaowen %A Wang,Lihua %A Cai,Meili %A Zhang,Yuqin %A Lu,Jiayi %A Wang,Yao %A Liu,Hongying %A Kuang,Ming %A Chen,Haibing %A Zhang,Manna %A Qu,Shen %+ Department of Endocrinology and Metabolism, Shanghai Tenth People’s Hospital, Tongji University School of Medicine, No. 301 Middle Yanchang Road, Shanghai, 200072, China, 86 13774448495, mannazhang@126.com %K polycystic ovary syndrome %K insulin resistance %K digital intervention %K metformin %K women’s health %D 2024 %7 2.10.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: The first-line treatment for polycystic ovary syndrome (PCOS) is lifestyle modification. However, it is currently unknown whether digital medicine can assist patients with PCOS in maintaining a healthy lifestyle while alleviating PCOS symptoms. Objective: This study aims to evaluate the efficacy of WeChat-based digital intervention versus metformin treatment in women with PCOS and insulin resistance. Methods: A total of 80 women with PCOS and insulin resistance were recruited from an endocrinology clinic and randomly assigned to receive either a WeChat-based digital intervention (n=40, 50%) or metformin (n=40, 50%) for 12 weeks. The WeChat-based digital intervention consisted of 3 modules; a coach assisted the patients in using the intervention. The primary outcome was the change in a homeostatic model assessment for insulin resistance. At baseline and after the 12-week intervention, anthropometric parameters, menstruation frequency, sex hormone levels, metabolic factors, and body fat distribution were measured in the clinic. Furthermore, self-assessed web-based questionnaires on diet, exercise, sleep, anxiety, and depression were obtained. Results: A total of 72 participants completed the follow-up (for a 90% follow-up rate), including 35 of 40 (88%) participants from the digital intervention group and 37 of 40 (93%) participants from the metformin group. The homeostatic model assessment for insulin resistance in the digital intervention group was significantly improved after 12 weeks of treatment with a mean change of –0.93 (95% CI –1.64 to –0.23), but no statistical difference was observed between the groups (least squares mean difference –0.20; 95% CI –0.98 to 0.58; P=.62). Both digital intervention and metformin treatment significantly improved menstruation frequency (digital intervention: P<.001; metformin: P<.001) and reduced body weight (digital intervention: P<.001; metformin: P<.001) and total fat mass (digital intervention: P<.001; metformin: P<.001). Furthermore, the digital intervention had a significant advantage over metformin in improving waist circumference (least squares mean difference –1.84; 95% CI –3.44 to –0.24; P=.03), waist-to-hip ratio (least squares mean difference –0.02; 95% CI –0.03 to 0.00; P=.03), total fat mass (least squares mean difference –1.59; 95% CI –2.88 to –0.30; P=.02), and dehydroepiandrosterone sulfate (least squares mean difference –69.73; 95% CI –129.70 to –9.75; P=.02). In terms of safety, the main adverse events were sensations of hunger in the digital intervention group (2/40, 5%) and gastrointestinal adverse events in the metformin group (12/40, 30%). Conclusions: Our data suggest that digital intervention is an effective treatment option for patients with PCOS, with an efficacy comparable to that of metformin, and that it can also alleviate the negative effects of medications and make it easier and more efficient to adhere to lifestyle treatments. WeChat-based digital interventions have the potential to provide a new path for the improvement and health of women with PCOS in China. Trial Registration: ClinicalTrials.gov NCT05386706; https://clinicaltrials.gov/study/NCT05386706 %M 39357046 %R 10.2196/55883 %U https://www.jmir.org/2024/1/e55883 %U https://doi.org/10.2196/55883 %U http://www.ncbi.nlm.nih.gov/pubmed/39357046 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e59269 %T Shaping Adoption and Sustained Use Across the Maternal Journey: Qualitative Study on Perceived Usability and Credibility in Digital Health Tools %A Ng,Wei Ying %A Lau,Ni Yin %A Lee,V Vien %A Vijayakumar,Smrithi %A Leong,Qiao Ying %A Ooi,Shu Qin Delicia %A Su,Lin Lin %A Lee,Yung Seng %A Chan,Shiao-Yng %A Blasiak,Agata %A Ho,Dean %+ The N.1 Institute for Health, National University of Singapore, 28 Medical Drive, #05-COR, Singapore, 117456, Singapore, 65 66017766, biedh@nus.edu.sg %K maternal and child health %K conception %K pregnancy %K perinatal care %K postpartum %K maternal care %K obstetric care %K user engagement %K Unified Theory of Acceptance and Use of Technology %K femtech %D 2024 %7 1.10.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Maternal and child health outcomes are positively influenced by early intervention, and digital health (DH) tools provide the potential for a low-cost and scalable solution such as informational platforms or digital tracking tools. Despite the wide availability of DH tools out there for women from before to after pregnancy, user engagement remains low. Objective: This study aims to explore the factors that shape women’s DH adoption and sustained use across the maternal journey from preconception to postbirth, to improve user engagement with DH tools. Methods: One-hour semistructured qualitative interviews were conducted with 44 women from before to after pregnancy (age range 21-40 years) about their experiences with DH. This study is part of a larger study on women’s maternal experiences with health care and DH and focuses on the factors that affected women’s DH adoption and sustained use. Interviews were audio recorded, transcribed verbatim, and analyzed using inductive thematic analysis. Results: Five main themes and 10 subthemes were identified that affected women’s adoption and sustained use of DH tools. These included themes on their preexisting attitudes to DH, perceived ease of use, perceived usefulness, perceived credibility, and perceived value of the tool. Conclusions: The themes that emerged were fully or partially mapped according to the Unified Theory of Acceptance and Use of Technology 2 model. The applicability of the model and the need to consider specific cultural nuances in the Asian context (such as the importance of trust and social influence) are discussed. The interaction of the 5 themes with DH adoption and sustained use are explored with different themes being relevant at various points of the DH adoption journey. The insights gained serve to inform future DH design and implementation of tools for women to optimize their DH engagement and the benefits they derive from it. Trial Registration: ClinicalTrials.gov NCT05099900; https://clinicaltrials.gov/study/NCT05099900 %M 39352732 %R 10.2196/59269 %U https://humanfactors.jmir.org/2024/1/e59269 %U https://doi.org/10.2196/59269 %U http://www.ncbi.nlm.nih.gov/pubmed/39352732 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e53767 %T Evaluation and Future Challenges in a Self-Guided Web-Based Intervention With and Without Chat Support for Depression and Anxiety Symptoms During the COVID-19 Pandemic: Randomized Controlled Trial %A Dominguez-Rodriguez,Alejandro %A Sanz-Gomez,Sergio %A González Ramírez,Leivy Patricia %A Herdoiza-Arroyo,Paulina Erika %A Trevino Garcia,Lorena Edith %A de la Rosa-Gómez,Anabel %A González-Cantero,Joel Omar %A Macias-Aguinaga,Valeria %A Arenas Landgrave,Paulina %A Chávez-Valdez,Sarah Margarita %+ School of Medicine and Health Sciences, Tecnologico de Monterrey, Avenue Gral Ramón Corona #2514, Colonia Nuevo México, Zapopan, 45201, Mexico, 52 3336693000, leivy@tec.mx %K self-guided web-based intervention %K chat support %K depression %K anxiety %K COVID-19 %K opinion %K usability %K randomized control trial %D 2024 %7 30.9.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: The COVID-19 pandemic has had an impact on mental health worldwide. Low- and middle-income countries were largely affected by it. Mexico was one of the most affected countries. Extended periods of lockdowns, isolation, and social distancing, among other factors, highlighted the need to introduce web-based psychological interventions to the Mexican population. In this context, Mental Health COVID-19 emerged as a self-guided web-based intervention (SGWI) aimed at adults to improve mental health during the COVID-19 pandemic. Objective: This study aims to assess the efficacy of 2 modalities of a self-guided intervention (with and without chat support) in reducing depression symptoms, generalized anxiety, community posttraumatic stress, widespread fear, anxiety, sleep quality, physiological and affective coping, and suicide ideation. In addition, it aimed to compare the moderating role of coping strategies, acceptance, and satisfaction in participants’ symptom reduction. We hypothesize that the self-guided, chat-supported modality will show higher efficacy than the modality without chat support in achieving clinical change and better performance as a moderator of depression symptoms, generalized anxiety, community posttraumatic stress, widespread fear, anxiety, sleep quality, physiological and affective coping, and suicide ideation, as well as an increase in participants’ satisfaction and acceptability. Methods: A randomized controlled trial was conducted. Data were collected from May 2020 to June 2022. We performed intrasubject measures at 4 evaluation periods: pretest, posttest, and follow-up measurements at 3 and 6 months. Differences between intervention groups were assessed through the Mann-Whitney U test for continuous variables and the chi-square test for categorical variables. Changes due to intervention were analyzed using Wilcoxon W test. Moderated regression analysis was performed to test the hypothesized moderating role of coping strategies, usability, and opinion about treatment on clinical change. Results: A total of 36 participants completed the intervention; of these, 5 (14%) were part of the SGWI group, and 31 (86%) were on the SGWI plus chat support (SGWI+C) group, which included a chat service with therapists. The perceived high complexity of the system for the SGWI group had a moderating effect associated with a lack of efficacy of the intervention regarding depression, but not when controlled for sociodemographic variables. A perception of lower helpfulness of the intervention was associated with poorer outcomes. Coping strategies did not show moderating effects. Conclusions: Enhancing the utility of web-based interventions for reducing clinical symptoms by incorporating a support chat to boost treatment adherence seemed to improve the perception of the intervention’s usefulness. Web-based interventions face several challenges, such as eliminating complexities in platform use and increasing the users’ perceived utility of the intervention, among other issues identified in the study. Trial Registration: ClinicalTrials.gov NCT04468893; https://clinicaltrials.gov/study/NCT04468893?tab=results International Registered Report Identifier (IRRID): RR2-10.2196/23117 %M 39348893 %R 10.2196/53767 %U https://formative.jmir.org/2024/1/e53767 %U https://doi.org/10.2196/53767 %U http://www.ncbi.nlm.nih.gov/pubmed/39348893 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e55576 %T Effectiveness of Internet-Based Telehealth Programs in Patients With Hip or Knee Osteoarthritis: Systematic Review and Meta-Analysis %A Wang,Hao-Nan %A Luo,Pei %A Liu,Shuyue %A Liu,Yunyi %A Zhang,Xiao %A Li,Jian %+ Sports Medicine Center, West China Hospital, Sichuan University, No 37, Guoxue Lane, Wuhou District, Chengdu, 610041, China, 86 18980601388, lijian_sportsmed@163.com %K osteoarthritis %K knee %K hip %K telehealth %K telemedicine %K telerehabilitation %K eHealth %K exercise %K PRISMA %D 2024 %7 30.9.2024 %9 Review %J J Med Internet Res %G English %X Background: Osteoarthritis (OA) is a chronic musculoskeletal disease that causes pain, functional disability, and an economic burden. Nonpharmacological treatments are at the core of OA management. However, limited access to these services due to uneven regional local availability has been highlighted. Internet-based telehealth (IBTH) programs, providing digital access to abundant health care resources, offer advantages, such as convenience and cost-effectiveness. These characteristics make them promising strategies for the management of patients with OA. Objective: This study aimed to evaluate the effectiveness of IBTH programs in the management of patients with hip or knee OA. Methods: We systematically searched 6 electronic databases to identify trials comparing IBTH programs with conventional interventions for hip and knee OA. Studies were selected based on inclusion and exclusion criteria, focusing on outcomes related to function, pain, and self-efficacy. Standardized mean differences (SMDs) with 95% CIs were calculated to compare outcome measures. Heterogeneity was assessed using I² and χ² tests. The methodological quality of the selected studies and the quality of evidence were also evaluated. Results: A total of 21 studies with low-to-high risk of bias were included in this meta-analysis. The pooled results showed that IBTH has a superior effect on increasing function (SMD 0.30, 95% CI 0.23-0.37, P<.001), relieving pain (SMD –0.27, 95% CI –0.34 to –0.19, P<.001), and improving self-efficacy for pain (SMD 0.21, 95% CI 0.08-0.34, P<.001) compared to the conventional intervention group. Subgroup analysis revealed that IBTH with exercise can significantly alleviate pain and improve function and self-efficacy, but IBTH with cognitive-behavioral therapy only had the effect of reducing pain. Conclusions: The meta-analysis provides moderate-quality evidence that IBTH programs have a beneficial effect on improving function, relieving pain, and improving self-efficacy compared to conventional interventions in patients with hip or knee OA. Limited evidence suggests that the inclusion of exercise regimens in IBTH programs is recommended. Trial Registration: PROSPERO CRD42024541111; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=541111 %M 39348685 %R 10.2196/55576 %U https://www.jmir.org/2024/1/e55576 %U https://doi.org/10.2196/55576 %U http://www.ncbi.nlm.nih.gov/pubmed/39348685 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e55322 %T Development of a 12-Week Unsupervised Online Tai Chi Program for People With Hip and Knee Osteoarthritis: Mixed Methods Study %A Zhu,Shiyi Julia %A Bennell,Kim L %A Hinman,Rana S %A Harrison,Jenny %A Kimp,Alexander J %A Nelligan,Rachel K %+ Department of Physiotherapy, School of Health Sciences, Centre for Health, Exercise and Sports Medicine, University of Melbourne, 161 Barry Street, Parkville, Melbourne, 3010, Australia, 61 3 8344 0556, k.bennell@unimelb.edu.au %K intervention development %K osteoarthritis %K Tai Chi %K web-based intervention %K online %K telehealth %K unsupervised exercise %K exercise %K physical activity %K arthritis %K development %K web based %K hip %K knee %K gerontology %K geriatric %K older adult %K aging %K bone %K workout %K digital health %K eHealth %K literature review %K telemedicine %D 2024 %7 30.9.2024 %9 Original Paper %J JMIR Aging %G English %X Background: Osteoarthritis is a leading contributor to global disability. While evidence supports the effectiveness of Tai Chi in improving symptoms for people with hip/knee osteoarthritis, access to in-person Tai Chi classes may be difficult for many people. An unsupervised online Tai Chi intervention for people with osteoarthritis can help overcome accessibility barriers. The Approach to Human-Centered, Evidence-Driven Adaptive Design (AHEAD) framework provides a practical guide for co-designing such an intervention. Objective: This study aims to develop an unsupervised online Tai Chi program for people with hip/knee osteoarthritis. Methods: An iterative process was conducted using the AHEAD framework. Initially, a panel of Tai Chi instructors and people with osteoarthritis was assembled. A literature review was conducted to inform the content of a survey (survey 1), which was completed by the panel and additional Australian Tai Chi instructors to identify Tai Chi movements for potential inclusion. Selection of Tai Chi movements was based on 3 criteria: those that were appropriate (for people with hip/knee osteoarthritis aged 45+ years), safe (to be performed at home unsupervised), and practical (to be delivered online using prerecorded videos). Movements that met these criteria were then ranked in a second survey (survey 2; using conjoint analysis methodology). Survey findings were discussed in a focus group, and the Tai Chi movements for program use were identified. A draft of the online Tai Chi program was developed, and a final survey (survey 3) was conducted with the panel to rate the appropriateness and safety of the proposed program. The final program was developed, and usability testing (think-aloud protocol) was conducted with people with knee osteoarthritis. Results: The panel consisted of 10 Tai Chi instructors and 3 people with osteoarthritis. The literature review identified Yang Style 24 as a common and effective Tai Chi style used in hip/knee osteoarthritis studies. Surveys 1 (n=35) and 2 (n=27) produced a ranked list of 24 Tai Chi movements for potential inclusion. This list was refined and informed by a focus group, with 10 Tai Chi movements being selected for inclusion (known as the Yang Style 10 form). Survey 3 (n=13) found that 92% (n=12) of the panel members believed that the proposed draft Tai Chi program was appropriate and safe, resulting in its adoption. The final program was produced and hosted on a customized website, “My Joint Tai Chi,” which was further refined based on user feedback (n=5). “My Joint Tai Chi” is currently being evaluated in a randomized controlled trial. Conclusions: This study demonstrates the use of the AHEAD framework to develop an unsupervised online Tai Chi intervention (“My Joint Tai Chi”) for people with hip/knee osteoarthritis. This intervention is now being tested for effectiveness and safety in a randomized controlled trial. %M 39348676 %R 10.2196/55322 %U https://aging.jmir.org/2024/1/e55322 %U https://doi.org/10.2196/55322 %U http://www.ncbi.nlm.nih.gov/pubmed/39348676 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53819 %T A Web-Based Antiretroviral Therapy Adherence Intervention (Thrive With Me) in a Community-Recruited Sample of Sexual Minority Men Living With HIV: Results of a Randomized Controlled Study %A Horvath,Keith J %A Lammert,Sara %A Erickson,Darin %A Amico,K Rivet %A Talan,Ali J %A Shalhav,Ore %A Sun,Christina J %A Rendina,H Jonathon %+ Department of Psychology, San Diego State University, 6363 Alvarado Court, Suite 250, San Deigo, CA, 92120, United States, 1 6196943346, khorvath@sdsu.edu %K HIV %K antiretroviral therapy %K ART %K mobile health %K mHealth %K intervention %K men who have sex with men %D 2024 %7 30.9.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Most new HIV infections are attributed to male-to-male sexual contact in the United States. However, only two-thirds of sexual minority men living with HIV achieve an undetectable viral load (UVL). We tested a web-based antiretroviral therapy adherence intervention called Thrive with Me (TWM) with core features that included medication self-monitoring and feedback, HIV and antiretroviral therapy information, and a peer-to-peer exchange. Objective: We assessed the efficacy of TWM on HIV UVL among adult (aged ≥18 years) sexual minority men. Moreover, we assessed the impact of overall engagement and engagement with specific intervention features on HIV UVL. Methods: In total, 401 sexual minority men (mean age 39.1, SD 10.8 y; 230/384, 59.9% African American) in New York City were recruited between October 2016 and December 2019 and randomized to receive TWM (intervention) or a weekly email newsletter (control) for 5 months. Computerized assessments occurred at baseline and months 5, 11, and 17. The primary outcome was a dichotomous measure of HIV UVL (≤20 copies/μL). Generalized estimating equations with robust SEs were used to assess the effect of the TWM intervention on HIV UVL over the follow-up period in an unadjusted model and a model adjusted for baseline differences and then stratified by baseline recent drug use urinalysis. In secondary analyses, generalized linear models were used to estimate risk differences in the association of overall engagement with TWM (the sum of the number of days participants accessed ≥1 screen of the TWM intervention out of a possible 150 days) and engagement with specific TWM components on HIV UVL throughout the 17-month intervention period. Results: Participant retention was 88.5% (355/401; month 5), 81.8% (328/401; month 11), and 80.3% (322/401; month 17). No consistent differences in HIV UVL were found between those randomized to receive TWM or the control at the 5- (difference-in-differences [DD]=–7.8, 95% CI –21.1 to 5.5), 11- (DD=–13.9, 95% CI –27.7 to 0.04), or 17-month (DD=–8.2, 95% CI –22.0 to 5.7) time points, or when stratified by baseline recent drug use. However, those TWM-assigned participants with high overall levels of engagement (in the upper 25th percentile) were more likely to have an HIV UVL at the end of the 5-month active intervention period compared to those with low engagement (below the 75th percentile; risk difference=17.8, 95% CI 2.5-33.0) or no engagement (risk difference=19.4, 95% CI 3.3-35.5) in the intervention. Moreover, high engagement with the peer-to-peer exchange was associated with HIV UVL over time in unadjusted models. Conclusions: TWM did not have overall impacts on HIV UVL; however, it may assist some sexual minority men who are highly engaged with this web-based intervention in achieving HIV viral suppression. Trial Registration: ClinicalTrials.gov NCT02704208; https://clinicaltrials.gov/study/NCT02704208 %M 39348677 %R 10.2196/53819 %U https://www.jmir.org/2024/1/e53819 %U https://doi.org/10.2196/53819 %U http://www.ncbi.nlm.nih.gov/pubmed/39348677 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e55164 %T Usability, Engagement, and Report Usefulness of Chatbot-Based Family Health History Data Collection: Mixed Methods Analysis %A Nguyen,Michelle Hoang %A Sedoc,João %A Taylor,Casey Overby %+ Institute for Computational Medicine, Johns Hopkins University, Hackerman Hall, Baltimore, MD, 21218, United States, 1 (410) 516 4116, mnguye79@jhmi.edu %K family health history %K chatbots %K conversational agents %K digital health tools %K usability %K engagement %K report usefulness %K evaluation %K crowdsourcing %K mixed methods %D 2024 %7 30.9.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Family health history (FHx) is an important predictor of a person’s genetic risk but is not collected by many adults in the United States. Objective: This study aims to test and compare the usability, engagement, and report usefulness of 2 web-based methods to collect FHx. Methods: This mixed methods study compared FHx data collection using a flow-based chatbot (KIT; the curious interactive test) and a form-based method. KIT’s design was optimized to reduce user burden. We recruited and randomized individuals from 2 crowdsourced platforms to 1 of the 2 FHx methods. All participants were asked to complete a questionnaire to assess the method’s usability, the usefulness of a report summarizing their experience, user-desired chatbot enhancements, and general user experience. Engagement was studied using log data collected by the methods. We used qualitative findings from analyzing free-text comments to supplement the primary quantitative results. Results: Participants randomized to KIT reported higher usability than those randomized to the form, with a mean System Usability Scale score of 80.2 versus 61.9 (P<.001), respectively. The engagement analysis reflected design differences in the onboarding process. KIT users spent less time entering FHx information and reported more conditions than form users (mean 5.90 vs 7.97 min; P=.04; and mean 7.8 vs 10.1 conditions; P=.04). Both KIT and form users somewhat agreed that the report was useful (Likert scale ratings of 4.08 and 4.29, respectively). Among desired enhancements, personalization was the highest-rated feature (188/205, 91.7% rated medium- to high-priority). Qualitative analyses revealed positive and negative characteristics of both KIT and the form-based method. Among respondents randomized to KIT, most indicated it was easy to use and navigate and that they could respond to and understand user prompts. Negative comments addressed KIT’s personality, conversational pace, and ability to manage errors. For KIT and form respondents, qualitative results revealed common themes, including a desire for more information about conditions and a mutual appreciation for the multiple-choice button response format. Respondents also said they wanted to report health information beyond KIT’s prompts (eg, personal health history) and for KIT to provide more personalized responses. Conclusions: We showed that KIT provided a usable way to collect FHx. We also identified design considerations to improve chatbot-based FHx data collection: First, the final report summarizing the FHx collection experience should be enhanced to provide more value for patients. Second, the onboarding chatbot prompt may impact data quality and should be carefully considered. Finally, we highlighted several areas that could be improved by moving from a flow-based chatbot to a large language model implementation strategy. %M 39348188 %R 10.2196/55164 %U https://www.jmir.org/2024/1/e55164 %U https://doi.org/10.2196/55164 %U http://www.ncbi.nlm.nih.gov/pubmed/39348188 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e57150 %T Leveraging Personal Technologies in the Treatment of Schizophrenia Spectrum Disorders: Scoping Review %A D'Arcey,Jessica %A Torous,John %A Asuncion,Toni-Rose %A Tackaberry-Giddens,Leah %A Zahid,Aqsa %A Ishak,Mira %A Foussias,George %A Kidd,Sean %+ Schizophrenia Division, Centre for Addiction and Mental Health, 1025 Queen Street West, Toronto, ON, M6J 1H1, Canada, 1 647 385 2490, jessica.darcey@mail.utoronto.ca %K schizophrenia %K digital mental health %K personal technology %K access to specialized resources %K mental health %K scoping review %K mental health care %K feasibility %K efficacy %K clinical integration %K support %K specialized care %K care %K database %K schizophrenia spectrum disorder %K text messaging %K text %K user feedback %K usability %K acceptability %K satisfaction %K engagement %K digital health %K digital mental health %K technology %K health technology %K mood disorder %K mood disorders %K neurodevelopment %K eHealth %K mobile phone %D 2024 %7 30.9.2024 %9 Review %J JMIR Ment Health %G English %X Background: Digital mental health is a rapidly growing field with an increasing evidence base due to its potential scalability and impacts on access to mental health care. Further, within underfunded service systems, leveraging personal technologies to deliver or support specialized service delivery has garnered attention as a feasible and cost-effective means of improving access. Digital health relevance has also improved as technology ownership in individuals with schizophrenia has improved and is comparable to that of the general population. However, less digital health research has been conducted in groups with schizophrenia spectrum disorders compared to other mental health conditions, and overall feasibility, efficacy, and clinical integration remain largely unknown. Objective: This review aims to describe the available literature investigating the use of personal technologies (ie, phone, computer, tablet, and wearables) to deliver or support specialized care for schizophrenia and examine opportunities and barriers to integrating this technology into care. Methods: Given the size of this review, we used scoping review methods. We searched 3 major databases with search teams related to schizophrenia spectrum disorders, various personal technologies, and intervention outcomes related to recovery. We included studies from the full spectrum of methodologies, from development papers to implementation trials. Methods and reporting follow the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Results: This search resulted in 999 studies, which, through review by at least 2 reviewers, included 92 publications. Included studies were published from 2010 to 2023. Most studies examined multitechnology interventions (40/92, 43%) or smartphone apps (25/92, 27%), followed by SMS text messaging (16/92, 17%) and internet-based interventions (11/92, 12%). No studies used wearable technology on its own to deliver an intervention. Regarding the stage of research in the field, the largest number of publications were pilot studies (32/92, 35%), followed by randomized control trials (RCTs; 20/92, 22%), secondary analyses (16/92, 17%), RCT protocols (16/92, 17%), development papers (5/92, 5%), and nonrandomized or quasi-experimental trials (3/92, 3%). Most studies did not report on safety indices (55/92, 60%) or privacy precautions (64/92, 70%). Included studies tend to report consistent positive user feedback regarding the usability, acceptability, and satisfaction with technology; however, engagement metrics are highly variable and report mixed outcomes. Furthermore, efficacy at both the pilot and RCT levels report mixed findings on primary outcomes. Conclusions: Overall, the findings of this review highlight the discrepancy between the high levels of acceptability and usability of these digital interventions, mixed efficacy results, and difficulties with sustained engagement. The discussion highlights common patterns that may underscore this observation in the field; however, as this was a scoping review, a more in-depth systematic review or meta-analysis may be required to better understand the trends outlined in this review. %M 39348196 %R 10.2196/57150 %U https://mental.jmir.org/2024/1/e57150 %U https://doi.org/10.2196/57150 %U http://www.ncbi.nlm.nih.gov/pubmed/39348196 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e55500 %T Digital Psychotherapies for Adults Experiencing Depressive Symptoms: Systematic Review and Meta-Analysis %A Omylinska-Thurston,Joanna %A Aithal,Supritha %A Liverpool,Shaun %A Clark,Rebecca %A Moula,Zoe %A Wood,January %A Viliardos,Laura %A Rodríguez-Dorans,Edgar %A Farish-Edwards,Fleur %A Parsons,Ailsa %A Eisenstadt,Mia %A Bull,Marcus %A Dubrow-Marshall,Linda %A Thurston,Scott %A Karkou,Vicky %+ School of Health and Society, University of Salford, Frederick Road Campus, Broad Street, Manchester, M6 6PU, United Kingdom, 44 0161 295 0000, j.omylinska-thurston1@salford.ac.uk %K digital psychotherapies %K depression %K adults %K systematic review %K meta-analysis %K mobile phone %D 2024 %7 30.9.2024 %9 Review %J JMIR Ment Health %G English %X Background: Depression affects 5% of adults and it is a major cause of disability worldwide. Digital psychotherapies offer an accessible solution addressing this issue. This systematic review examines a spectrum of digital psychotherapies for depression, considering both their effectiveness and user perspectives. Objective: This review focuses on identifying (1) the most common types of digital psychotherapies, (2) clients’ and practitioners’ perspectives on helpful and unhelpful aspects, and (3) the effectiveness of digital psychotherapies for adults with depression. Methods: A mixed methods protocol was developed using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The search strategy used the Population, Intervention, Comparison, Outcomes, and Study Design (PICOS) framework covering 2010 to 2024 and 7 databases were searched. Overall, 13 authors extracted data, and all aspects of the review were checked by >1 reviewer to minimize biases. Quality appraisal was conducted for all studies. The clients’ and therapists’ perceptions on helpful and unhelpful factors were identified using qualitative narrative synthesis. Meta-analyses of depression outcomes were conducted using the standardized mean difference (calculated as Hedges g) of the postintervention change between digital psychotherapy and control groups. Results: Of 3303 initial records, 186 records (5.63%; 160 studies) were included in the review. Quantitative studies (131/160, 81.8%) with a randomized controlled trial design (88/160, 55%) were most common. The overall sample size included 70,720 participants (female: n=51,677, 73.07%; male: n=16,779, 23.73%). Digital interventions included “stand-alone” or non–human contact interventions (58/160, 36.2%), “human contact” interventions (11/160, 6.8%), and “blended” including stand-alone and human contact interventions (91/160, 56.8%). What clients and practitioners perceived as helpful in digital interventions included support with motivation and accessibility, explanation of task reminders, resources, and learning skills to manage symptoms. What was perceived as unhelpful included problems with usability and a lack of direction or explanation. A total of 80 studies with 16,072 participants were included in the meta-analysis, revealing a moderate to large effect in favor of digital psychotherapies for depression (Hedges g=–0.61, 95% CI –0.75 to –0.47; Z=–8.58; P<.001). Subgroup analyses of the studies with different intervention delivery formats and session frequency did not have a statistically significant effect on the results (P=.48 and P=.97, respectively). However, blended approaches revealed a large effect size (Hedges g=–0.793), while interventions involving human contact (Hedges g=–0.42) or no human contact (Hedges g=–0.40) had slightly smaller effect sizes. Conclusions: Digital interventions for depression were found to be effective regardless of format and frequency. Blended interventions have larger effect size than those involving human contact or no human contact. Digital interventions were helpful especially for diverse ethnic groups and young women. Future research should focus on understanding the sources of heterogeneity based on intervention and population characteristics. Trial Registration: PROSPERO CRD42021238462; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=238462 %M 39348177 %R 10.2196/55500 %U https://mental.jmir.org/2024/1/e55500 %U https://doi.org/10.2196/55500 %U http://www.ncbi.nlm.nih.gov/pubmed/39348177 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e54119 %T Just-in-Time Adaptive Interventions for Behavior Change in Physiological Health Outcomes and the Use Case for Knee Osteoarthritis: Systematic Review %A Fiedler,Janis %A Bergmann,Matteo Reiner %A Sell,Stefan %A Woll,Alexander %A Stetter,Bernd J %+ Institute of Sports and Sports Science, Karlsruhe Institute of Technology, Engler-Bunte-Ring 15, Karlsruhe, 76131, Germany, 49 721 608 46978, janis.fiedler@kit.edu %K eHealth %K application %K applications %K digital health %K digital technology %K digital intervention %K digital interventions %K physical activity %K sedentary behavior %K sedentary lifestyle %K pain %K physical function %K quality of life %K knee osteoarthritis %K osteopathy %K bone %K arthritis %K mobile phone %K individualization %D 2024 %7 27.9.2024 %9 Review %J J Med Internet Res %G English %X Background: The prevalence of knee osteoarthritis (KOA) in the adult population is high and patients profit from individualized therapy approaches. Just-in-time adaptive interventions (JITAIs) are upcoming digital interventions for behavior change. Objective: This systematic review summarizes the features and effectiveness of existing JITAIs regarding important physiological health outcomes and derives the most promising features for the use case of KOA. Methods: The electronic databases PubMed, Web of Science, Scopus, and EBSCO were searched using keywords related to JITAIs, physical activity (PA), sedentary behavior (SB), physical function, quality of life, pain, and stiffness. JITAIs for adults that focused on the effectiveness of at least 1 of the selected outcomes were included and synthesized qualitatively. Study quality was assessed with the Quality Assessment Tool Effective Public Health Practice Project. Results: A total of 45 studies with mainly weak overall quality were included in this review. The studies were mostly focused on PA and SB and no study examined stiffness. The design of JITAIs varied, with a frequency of decision points from a minute to a day, device-based measured and self-reported tailoring variables, intervention options including audible or vibration prompts and tailored feedback, and decision rules from simple if-then conditions based on 1 variable to more complex algorithms including contextual variables. Conclusions: The use of frequent decision points, device-based measured tailoring variables accompanied by user input, intervention options tailored to user preferences, and simple decision rules showed the most promising results in previous studies. This can be transferred to a JITAI for the use case of KOA by using target variables that include breaks in SB and an optimum of PA considering individual knee load for the health benefits of patients. %M 39331951 %R 10.2196/54119 %U https://www.jmir.org/2024/1/e54119 %U https://doi.org/10.2196/54119 %U http://www.ncbi.nlm.nih.gov/pubmed/39331951 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e56691 %T Long-Term Effects of Internet-Based Cognitive Behavioral Therapy on Depression Prevention Among University Students: Randomized Controlled Factorial Trial %A Nakagami,Yukako %A Uwatoko,Teruhisa %A Shimamoto,Tomonari %A Sakata,Masatsugu %A Toyomoto,Rie %A Yoshida,Kazufumi %A Luo,Yan %A Shiraishi,Nao %A Tajika,Aran %A Sahker,Ethan %A Horikoshi,Masaru %A Noma,Hisashi %A Iwami,Taku %A Furukawa,Toshi A %K iCBT %K depression prevention %K student mental health %K factorial randomized controlled trial %K mobile phone %D 2024 %7 24.9.2024 %9 %J JMIR Ment Health %G English %X Background: Internet-based cognitive behavioral therapy (iCBT) shows promise in the prevention of depression. However, the specific iCBT components that contribute to its effectiveness remain unclear. Objective: We aim to evaluate the effects of iCBT components in preventing depression among university students. Methods: Using a smartphone cognitive behavioral therapy (CBT) app, we randomly allocated university students to the presence or absence of 5 different iCBT components: self-monitoring, behavioral activation, cognitive restructuring, assertiveness training, and problem-solving. The active intervention lasted 8 weeks but the app remained accessible through the follow-up. The primary outcome was the onset of a major depressive episode (MDE) between baseline and the follow-up after 52 weeks, as assessed with the computerized World Health Organization Composite International Diagnostic Interview. Secondary outcomes included changes in the 9-item Patient Health Questionnaire, 7-item General Anxiety Disorder, and CBT Skills Scale. Results: During the 12-month follow-up, 133 of 1301 (10.22%) participants reported the onset of an MDE. There were no significant differences in the incidence of MDEs between the groups with or without each component (hazard ratios ranged from 0.85, 95% CI 0.60‐1.20, for assertiveness training to 1.26, 95% CI 0.88‐1.79, for self-monitoring). Furthermore, there were no significant differences in the changes on the 9-item Patient Health Questionnaire, 7-item General Anxiety Disorder, or for CBT Skills Scale between component allocation groups. However, significant reductions in depression and anxiety symptoms were observed among all participants at the 52-week follow-up. Conclusions: In this study, we could not identify any specific iCBT components that were effective in preventing depression or the acquisition of CBT skills over the 12-month follow-up period, but all participants with and without intervention of each iCBT component demonstrated significant improvements in depressive and anxiety symptoms. Further research is needed to explore the potential impact of frequency of psychological assessments, nonspecific intervention effects, natural change in the mental state, and the baseline depression level. Trial Registration: UMINCTR UMIN000031307; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035735 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-018-2719-z %R 10.2196/56691 %U https://mental.jmir.org/2024/1/e56691 %U https://doi.org/10.2196/56691 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e53759 %T Smartphone-Based Digital Peer Support for a Walking Intervention Among Public Officers in Kanagawa Prefecture: Single-Arm Pre- and Postintervention Evaluation %A Okamoto,Masumi %A Saito,Yoshinobu %A Nakamura,Sho %A Nagasawa,Makoto %A Shibuya,Megumi %A Nagasaka,Go %A Narimatsu,Hiroto %+ Graduate School of Health Innovation, Kanagawa University of Human Services, Research Gate Building Tonomachi 2-A, 3-25-10 Tonomachi, Kawasaki-ku, Kawasaki, 210-0821, Japan, 81 44 589 8100, hiroto-narimatsu@umin.org %K digital health %K mhealth %K ehealth %K smartphone app %K smartphone application %K peer support %K digital peer support %K social support %K group intervention %K physical activity %K health promotion %K behavior change %K apps %K step counting %K workplace health %D 2024 %7 24.9.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital peer support, defined as peer support delivered through technology such as smartphone apps, may be promising to promote activity in the form of step counts. Interactions among users have a positive impact on retention rates, and apps with social elements show significant improvements in daily step count. However, the feasibility of digital peer support in promoting physical activity (PA) is unknown; therefore, its effectiveness on step count and the clinical implications remain unconfirmed. Objective: This study aimed to assess the feasibility of digital peer support over a 3-month intervention period using the retention rate as the outcome. Moreover, changes in daily step count and physical measurements were compared between pre- and postintervention. Methods: The study design was a 3-month 1-arm intervention with participants from local government offices in Kanagawa, Japan. We used an available smartphone app, Minchalle, as the tool for the group intervention. Participants were required to report their daily step count to a maximum of 5 members composed exclusively of study participants. The primary outcome was the retention rate. Secondary outcomes included daily step count, the rate of achieving daily step goals, physical measurements, and lifestyle characteristics. Descriptive statistics and the Pearson coefficient were used to examine the relationship between goal achievement and step count, as well as changes in step count and various variables including physical measurements. Results: Of the 63 participants, 62 completed the intervention. The retention rate was 98% (62/63). The average daily step count during the intervention was 6993 (SD 2328) steps, an 1182-step increase compared with the count observed 1 week before the intervention began. The rate of achieving the daily step count during the intervention was 53.5% (SD 26.2%). There was a significant correlation (r=0.27, P=.05) between achieving daily step goals and increasing daily step count. Comparative analyses showed that changes in weight (68.56, SD 16.97 kg vs 67.30, SD 16.86 kg; P<.001), BMI (24.82, SD 4.80 kg/m2 vs 24.35, SD 4.73 kg/m2; P<.001), somatic fat rate (28.50%, SD 7.44% vs 26.58%, SD 7.90%; P=.005), systolic blood pressure (130.42, SD 17.92 mm Hg vs 122.00, SD 15.06 mm Hg; P<.001), and diastolic blood pressure (83.24, SD 13.27 mm Hg vs 77.92, SD 11.71 mm Hg; P=.002) were significantly different before and after the intervention. Similarly, the daily amount of PA significantly improved from 5.77 (SD 3.81) metabolic equivalent (MET)–hours per day to 9.85 (SD 7.84) MET-hours per day (P<.001). Conclusions: This study demonstrated that digital peer support is feasible for maintaining a high retention rate and can, therefore, effectively promote PA. It can be a promising tool to improve daily step count, subjective PA, and clinical outcomes, such as weight and somatic fat rate. Trial Registration: UMIN Clinical Trials Registry UMIN000042520; https://tinyurl.com/46c4nm8z %M 39316793 %R 10.2196/53759 %U https://formative.jmir.org/2024/1/e53759 %U https://doi.org/10.2196/53759 %U http://www.ncbi.nlm.nih.gov/pubmed/39316793 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e53034 %T Digital Intervention to Improve Health Services for Young People in Zimbabwe: Process Evaluation of ‘Zvatinoda!’ (What We Want) Using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) Framework %A Mackworth-Young,Constance Ruth Sina %A Charashika,Privillage %A , %A Larsson,Leyla %A Wilding-Davies,Olivia Jane %A Simpson,Nikita %A Kydd,Anna Sorrel %A Chinyanga,Theonevus Tinashe %A Ferrand,Rashida Abbas %A Mangombe,Aveneni %A Webb,Karen %A Doyle,Aoife Margaret %+ Department of Global Health and Development, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, United Kingdom, 44 20 7636 8636, constance.mackworth-young1@lshtm.ac.uk %K adolescents %K young people %K digital health %K mobile intervention %K HIV %K sexual and reproductive health %K Zimbabwe %D 2024 %7 24.9.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Youth in Southern Africa face a high burden of HIV and sexually transmitted infections, yet they exhibit low uptake of health care services. Objective: The Zvatinoda! intervention, co-designed with youth, aims to increase the demand for and utilization of health services among 18-24-year-olds in Chitungwiza, Zimbabwe. Methods: The intervention utilized mobile phone–based discussion groups, complemented by “ask the expert” sessions. Peer facilitators, supported by an “Auntie,” led youth in anonymous online chats on health topics prioritized by the participants. Feedback on youth needs was compiled and shared with health care providers. The intervention was tested in a 12-week feasibility study involving 4 groups of 7 youth each, totaling 28 participants (n=14, 50%, female participants), to evaluate feasibility and acceptability. Mixed methods process evaluation data included pre- and postintervention questionnaires (n=28), in-depth interviews with participants (n=15) and peer facilitators (n=4), content from discussion group chats and expert guest sessions (n=24), facilitators’ debrief meetings (n=12), and a log of technical challenges. Descriptive quantitative analysis and thematic qualitative analysis were conducted. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework was adapted to analyze and present findings on (1) reach, (2) potential efficacy, (3) adoption, (4) implementation, and (5) maintenance. Results: Mobile delivery facilitated engagement with diverse groups, even during COVID-19 lockdowns (reach). Health knowledge scores improved from pre- to postintervention across 9 measures. Preintervention scores varied from 14% (4/28) for contraception to 86% (24/28) for HIV knowledge. After the intervention, all knowledge scores reached 100% (28/28). Improvements were observed across 10 sexual and reproductive health (SRH) self-efficacy measures. The most notable changes were in the ability to start a conversation about SRH with older adults in the family, which increased from 50% (14/28) preintervention to 86% (24/28) postintervention. Similarly, the ability to use SRH services even if a partner does not agree rose from 57% (16/28) preintervention to 89% (25/28) postintervention. Self-reported attendance at a health center in the past 3 months improved from 32% (9/28) preintervention to 86% (24/28) postintervention (potential efficacy). Chat participation varied, largely due to network challenges and school/work commitments. The key factors facilitating peer learning were interaction with other youth, the support of an older, knowledgeable “Auntie,” and the anonymity of the platform. As a result of COVID-19 restrictions, regular feedback to providers was not feasible. Instead, youth conveyed their needs to stakeholders through summaries of key themes from chat groups and a music video presented at a final in-person workshop (adoption and implementation). Participation in discussions decreased over time. To maintain engagement, introducing an in-person element was suggested (maintenance). Conclusions: The Zvatinoda! intervention proved both acceptable and feasible, showing promise for enhancing young people’s knowledge and health-seeking behavior. Potential improvements include introducing in-person discussions once the virtual group has established rapport and enhancing feedback and dialog with service providers. %M 39316784 %R 10.2196/53034 %U https://formative.jmir.org/2024/1/e53034 %U https://doi.org/10.2196/53034 %U http://www.ncbi.nlm.nih.gov/pubmed/39316784 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e48020 %T mHealth Physical Activity and Patient-Reported Outcomes in Patients With Inflammatory Bowel Diseases: Cluster Analysis %A Griffin,Ashley C %A Mentch,Lucas %A Lin,Feng-Chang %A Chung,Arlene E %+ VA Palo Alto Health Care System, 795 Willow Road, Palo Alto, CA, 94025, United States, 1 6504935000, griffina@stanford.edu %K inflammatory bowel diseases %K patient-reported outcome measures %K cluster analysis %K wearable electronic devices %K medical informatics %K mHealth %K mobile health %K physical activity %K bowel disease %K psychosocial %K smartphone %K wearables %K mobile phone %D 2024 %7 24.9.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Regular physical activity is associated with improved quality of life in patients with inflammatory bowel diseases (IBDs), although much of the existing research is based on self-reported data. Wearable devices provide objective data on many rich physical activity dimensions including steps, duration, distance, and intensity. Little is known about how patients with IBDs engage in these varying dimensions of exercise and how it may influence their symptom and disease-specific patient-reported outcomes (PROs). Objective: This study aims to (1) cluster physical activity patterns from consumer-grade wearable devices and (2) assess the relationship between the clusters and PROs in patients with IBDs. Methods: We conducted a cross-sectional and longitudinal cohort study among adults with IBDs in the Crohn’s and Colitis Foundation IBD Partners cohort. Participants contribute physical activity data through smartphone apps or wearable devices in a bring-your-own-device model. Participants also complete biannual PRO questionnaires from the Patient-Reported Outcomes Measurement Information System short forms and IBD-specific questionnaires. K-means cluster analysis was used to generate physical activity clusters based on 3 key features: number of steps, duration of moderate to vigorous activity (minutes), and distance of activity (miles). Based on the clusters, we conducted a cross-sectional analysis to examine differences in mean questionnaire scores and participant characteristics using one-way ANOVA and chi-square tests. We also conducted a longitudinal analysis to examine individual cluster transitions among participants who completed multiple questionnaires, and mean differences in questionnaire scores were compared using 2-tailed paired sample t tests across 6-month periods. Results: Among 430 participants comprising 1255 six-week physical activity periods, we identified clusters of low (33.7%, n=423), moderate (46%, n=577), and high (20.3%, n=255) physical activity. Scores varied across clusters for depression (P=.004), pain interference (P<.001), fatigue (P<.001), sleep disturbance (P<.001), social satisfaction (P<.001), and short Crohn Disease Activity Index (P<.001), with those in the low activity cluster having the worst scores. Sociodemographic characteristics also differed, and those with low physical activity were older (P=.002), had higher BMIs (P<.001), and had longer disease durations (P=.02) compared to other clusters. Among 246 participants who completed at least 2 consecutive questionnaires consisting of 726 questionnaire periods, 67.8% (n=492) remained in the same cluster, and only 1.2% (n=9) moved to or from the furthest clusters of low and high activity across 6-month periods. Conclusions: For patients with IBDs, there were positive associations between physical activity and PROs related to disease activity and psychosocial domains. Physical activity patterns mostly did not fluctuate over time, suggesting little variation in exercise levels in the absence of an intervention. The use of real-world data to identify subgroups with similar lifestyle behaviors could be leveraged to develop targeted interventions that provide support for psychosocial symptoms and physical activity for personalized IBD care. %M 39316795 %R 10.2196/48020 %U https://www.jmir.org/2024/1/e48020 %U https://doi.org/10.2196/48020 %U http://www.ncbi.nlm.nih.gov/pubmed/39316795 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e52345 %T From Digital Inclusion to Digital Transformation in the Prevention of Drug-Related Deaths in Scotland: Qualitative Study %A Daneshvar,Hadi %A Carver,Hannah %A Strachan,Graeme %A Greenhalgh,Jessica %A Matheson,Catriona %+ School of Health and Social Care, Edinburgh Napier University, Sighthill Campus, 9 Sighthill Court, Edinburgh, EH11 4BN, United Kingdom, 44 (0)131455 2929, h.daneshvar@napier.ac.uk %K digital inclusion %K digital transformation %K digital health %K drug-related death %K digitalization %K drug overdose %K drug overdose death %K harm reduction %K mobile phone %K digital divide %D 2024 %7 24.9.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Globally, drug-related deaths (DRDs) are increasing, posing a significant challenge. Scotland has the highest DRD rate in Europe and one of the highest globally. The Scottish Government launched the Digital Lifelines Scotland (DLS) program to increase the provision of digital technology in harm reduction services and other support services. Digital technology responses to DRDs can include education through digital platforms, improved access to treatment and support via telehealth and mobile apps, analysis of data to identify risk factors, and the use of digital tools for naloxone distribution. However, digital technology should be integrated into a comprehensive approach that increases access to services and addresses underlying causes. Digital transformation could enhance harm reduction service and support, but challenges must be addressed for successful implementation. The DLS program aims to enhance digital inclusion and improve health outcomes for people who use or are affected by drug use to reduce the risk of DRDs. Objective: This study aims to explore the role of digital technology as an enabler and supporter in enhancing existing services and innovating new solutions, rather than being a stand-alone solution. Specifically focusing on individuals who use drugs, the research investigates the potential of digital inclusion and technology provision for preventing DRDs within the context of the DLS program. Methods: Semistructured interviews were conducted with 47 people: 21 (45%) service users, 14 (30%) service providers, and 12 (26%) program staff who were all involved in DLS. Interviews were audio recorded, transcribed, and then coded. Analysis was done in three phases: (1) thematic analysis of interview data to identify the benefits of digital technologies in this sector; (2) identification of the challenges and enablers of using digital technologies using the Technology, People, Organizations, and Macroenvironment conceptual framework; and (3) mapping digital technology provision to services offered to understand the extent of digital transformation of the field. Results: Participants identified increased connectivity, enhanced access to services, and improved well-being as key benefits. Digital devices facilitated social connections, alleviated loneliness, and fostered a sense of community. Devices enabled engagement with services and support workers, providing better access to resources. In addition, digital technology was perceived as a preventive measure to reduce harmful drug use. Lack of technical knowledge, organizational constraints, and usability challenges, including device preferences and security issues, were identified. Conclusions: The study found that digital inclusion through the provision of devices and connections has the potential to enhance support in the harm reduction sector. However, it highlighted the limitations of existing digital inclusion programs in achieving comprehensive digital transformation. To progress, there is a need for sustained engagement, cultural change, and economic considerations to overcome barriers. %M 39316786 %R 10.2196/52345 %U https://www.jmir.org/2024/1/e52345 %U https://doi.org/10.2196/52345 %U http://www.ncbi.nlm.nih.gov/pubmed/39316786 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e50508 %T User Engagement With mHealth Interventions to Promote Treatment Adherence and Self-Management in People With Chronic Health Conditions: Systematic Review %A Eaton,Cyd %A Vallejo,Natalie %A McDonald,Xiomara %A Wu,Jasmine %A Rodríguez,Rosa %A Muthusamy,Nishanth %A Mathioudakis,Nestoras %A Riekert,Kristin A %+ Johns Hopkins School of Medicine, 5200 Eastern Avenue, Baltimore, MD, 21224, United States, 1 6673066201, ceaton4@jhmi.edu %K mobile health %K mHealth %K digital health %K treatment adherence %K self-management %K user engagement %K chronic health conditions %K mobile phone %D 2024 %7 24.9.2024 %9 Review %J J Med Internet Res %G English %X Background: There are numerous mobile health (mHealth) interventions for treatment adherence and self-management; yet, little is known about user engagement or interaction with these technologies. Objective: This systematic review aimed to answer the following questions: (1) How is user engagement defined and measured in studies of mHealth interventions to promote adherence to prescribed medical or health regimens or self-management among people living with a health condition? (2) To what degree are patients engaging with these mHealth interventions? (3) What is the association between user engagement with mHealth interventions and adherence or self-management outcomes? (4) How often is user engagement a research end point? Methods: Scientific database (Ovid MEDLINE, Embase, Web of Science, PsycINFO, and CINAHL) search results (2016-2021) were screened for inclusion and exclusion criteria. Data were extracted in a standardized electronic form. No risk-of-bias assessment was conducted because this review aimed to characterize user engagement measurement rather than certainty in primary study results. The results were synthesized descriptively and thematically. Results: A total of 292 studies were included for data extraction. The median number of participants per study was 77 (IQR 34-164). Most of the mHealth interventions were evaluated in nonrandomized studies (157/292, 53.8%), involved people with diabetes (51/292, 17.5%), targeted medication adherence (98/292, 33.6%), and comprised apps (220/292, 75.3%). The principal findings were as follows: (1) >60 unique terms were used to define user engagement; “use” (102/292, 34.9%) and “engagement” (94/292, 32.2%) were the most common; (2) a total of 11 distinct user engagement measurement approaches were identified; the use of objective user log-in data from an app or web portal (160/292, 54.8%) was the most common; (3) although engagement was inconsistently evaluated, most of the studies (99/195, 50.8%) reported >1 level of engagement due to the use of multiple measurement methods or analyses, decreased engagement across time (76/99, 77%), and results and conclusions suggesting that higher engagement was associated with positive adherence or self-management (60/103, 58.3%); and (4) user engagement was a research end point in only 19.2% (56/292) of the studies. Conclusions: The results revealed major limitations in the literature reviewed, including significant variability in how user engagement is defined, a tendency to rely on user log-in data over other measurements, and critical gaps in how user engagement is evaluated (infrequently evaluated over time or in relation to adherence or self-management outcomes and rarely considered a research end point). Recommendations are outlined in response to our findings with the goal of improving research rigor in this area. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42022289693; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022289693 %M 39316431 %R 10.2196/50508 %U https://www.jmir.org/2024/1/e50508 %U https://doi.org/10.2196/50508 %U http://www.ncbi.nlm.nih.gov/pubmed/39316431 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e58636 %T Chatbot-Led Support Combined With Counselor-Led Support on Smoking Cessation in China: Protocol for a Pilot Randomized Controlled Trial %A Weng,Xue %A Yin,Hua %A Liu,Kefeng %A Song,Chuyu %A Xie,Jiali %A Guo,Ningyuan %A Wang,Man Ping %+ Institute of Advanced Studies in Humanities and Social Sciences, Beijing Normal University, No.18, Jinfeng Road, Tangjiawan, Zhuhai, 519087, China, 86 (0756)3621259, xueweng@bnu.edu.cn %K chatbot %K smoking cessation %K mHealth %K mobile phone %K campus %K China %D 2024 %7 23.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: China has a large population of smokers, with half of them dependent on tobacco and in need of cessation assistance, indicating the need for mobile health (mHealth) to provide cessation support. Objective: The study aims to assess the feasibility and preliminary effectiveness of combining chatbot-led support with counselor-led support for smoking cessation among community smokers in China. Methods: This is a 2-arm, parallel, assessor-blinded, pilot randomized controlled trial nested in a smoke-free campus campaign in Zhuhai, China. All participants will receive brief face-to-face cessation advice and group cessation support led by a chatbot embedded in WeChat. In addition, participants in the intervention group will receive personalized WeChat-based counseling from trained counselors. Follow-up will occur at 1, 3, and 6 months after treatment initiation. The primary smoking outcome is bioverified abstinence (exhaled carbon monoxide <4 parts per million or salivary cotinine <30 ng/mL) at 6 months. Secondary outcomes include self-reported 7-day point prevalence of abstinence, smoking reduction rate, and quit attempts. Feasibility outcomes include eligibility rate, consent rate, intervention engagement, and retention rate. An intention-to-treat approach and regression models will be used for primary analyses. Results: Participant recruitment began in March 2023, and the intervention began in April 2023. The data collection was completed in June 2024. The results of the study will be published in peer-reviewed journals and presented at international conferences. Conclusions: This study will provide novel insights into the feasibility and preliminary effectiveness of a chatbot-led intervention for smoking cessation in China. The findings of this study will inform the development and optimization of mHealth interventions for smoking cessation in China and other low- and middle-income countries. Trial Registration: ClinicalTrials.gov NCT05777005; https://clinicaltrials.gov/study/NCT05777005 International Registered Report Identifier (IRRID): DERR1-10.2196/58636 %M 39312291 %R 10.2196/58636 %U https://www.researchprotocols.org/2024/1/e58636 %U https://doi.org/10.2196/58636 %U http://www.ncbi.nlm.nih.gov/pubmed/39312291 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e60361 %T Neural Conversational Agent for Weight Loss Counseling: Protocol for an Implementation and Feasibility Study %A Kotov,Alexander %A Idalski Carcone,April %A Towner,Elizabeth %+ Department of Computer Science, College of Engineering, Wayne State University, Suite 14001.6, 5057 Woodward Ave, Detroit, MI, 48202, United States, 1 3135779307, kotov@wayne.edu %K conversational agents %K artificial intelligence %K behavior change %K weight loss %K obesity %K motivational interviewing %K web-based application %K deep learning %K transformers %K large language models %K feasibility study %D 2024 %7 20.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Obesity is a common, serious and costly chronic disease. Current clinical practice guidelines recommend that providers augment the longitudinal care of people living with obesity with consistent support for the development of self-efficacy and motivation to modify their lifestyle behaviors. Lifestyle behavior change aligns with the goals of motivational interviewing (MI), a client-centered yet directive counseling modality. However, training health care providers to be proficient in MI is expensive and time-consuming, resulting in a lack of trained counselors and limiting the widespread adoption of MI in clinical practice. Artificial intelligence (AI) counselors accessible via the internet can help circumvent these barriers. Objective: The primary objective is to explore the feasibility of conducting unscripted MI-consistent counseling using Neural Agent for Obesity Motivational Interviewing (NAOMI), a large language model (LLM)–based web app for weight loss counseling. The secondary objectives are to test the acceptability and usability of NAOMI’s counseling and examine its ability to shift motivational precursors in a sample of patients with overweight and obesity recruited from primary care clinics. Methods: NAOMI will be developed based on recent advances in deep learning in four stages. In stages 1 and 2, NAOMI will be implemented using an open-source foundation LLM and (1) few-shot learning based on a prompt with task-specific instructions and (2) domain adaptation strategy based on fine-tuning LLM using a large corpus of general psychotherapy and MI treatment transcripts. In stages 3 and 4, we will refine the best of these 2 approaches. Each NAOMI version will be evaluated using a mixed methods approach in which 10 adults (18-65 years) meeting the criteria for overweight or obesity (25.0≥BMI≤39.9) interact with NAOMI and provide feedback. NAOMI’s fidelity to the MI framework will be assessed using the Motivational Interviewing Treatment Integrity scale. Participants’ general perceptions of AI conversational agents and NAOMI specifically will be assessed via Pre- and Post-Interaction Questionnaires. Motivational precursors, such as participants’ confidence, importance, and readiness for changing lifestyle behaviors (eg, diet and activity), will be measured before and after the interaction, and 1 week later. A qualitative analysis of changes in the measures of perceptions of AI agents and counselors and motivational precursors will be performed. Participants will rate NAOMI’s usability and empathic skills post interaction via questionnaire-based assessments along with providing feedback about their experience with NAOMI via a qualitative interview. Results: NAOMI (version 1.0) has been developed. Participant recruitment will commence in September 2024. Data collection activities are expected to conclude in May 2025. Conclusions: If proven effective, LLM-based counseling agents can become a cost-effective approach for addressing the obesity epidemic at a public health level. They can also have a broad, transformative impact on the delivery of MI and other psychotherapeutic treatment modalities extending their reach and broadening access. International Registered Report Identifier (IRRID): PRR1-10.2196/60361 %M 39303273 %R 10.2196/60361 %U https://www.researchprotocols.org/2024/1/e60361 %U https://doi.org/10.2196/60361 %U http://www.ncbi.nlm.nih.gov/pubmed/39303273 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e50289 %T Effect of a Web-Based Nutritional and Physical Activity Intervention With Email Support (the EDDY Program) on Primary School Children’s BMI Z-Score During the COVID-19 Pandemic: Intervention Study %A Gansterer,Alina %A Moliterno,Paula %A Neidenbach,Rhoia %A Ollerieth,Caroline %A Czernin,Sarah %A Scharhag,Juergen %A Widhalm,Kurt %K childhood obesity %K BMI %K prevention intervention %K physical activity %K nutrition %K nutritional %K school-based %K web-based %K COVID-19 %K diet %K child %K childhood %K children %K pediatric %K pediatrics %K weight %K obesity %K obese %K exercise %K school %K student %K students %K youth %D 2024 %7 19.9.2024 %9 %J JMIR Pediatr Parent %G English %X Background: COVID-19 mitigation measures enhanced increases in children’s weight and BMI due to decreased physical activity and increased energy intake. Overweight and obesity were major worldwide problems before the pandemic, and COVID-19 increased their severity even more. High BMI directly correlates with health disadvantages including cardiovascular diseases, musculoskeletal disorders, and mental health diseases. Therefore, it is vitally important to develop counteracting interventions to maintain children’s health during exceptional situations like pandemics. However, worldwide data from such interventions are limited, and to our knowledge, no suitable study has been carried out during the pandemic in Austria. Objective: This study was conducted to examine a 15-week web-based intervention with email support, the EDDY (Effect of Sports and Diet Trainings to Prevent Obesity and Secondary Diseases and to Influence Young Children’s Lifestyle) program and the effect of nutritional education and physical activity on children’s BMI z-score during the COVID-19 pandemic in Vienna, Austria. Methods: The intervention consisted of 3 weekly videos—2 physical activity and 1 nutritional education video, respectively—and a biweekly email newsletter for the parents. This study was conducted in a Viennese primary school from February to June 2021 by a team of physicians, nutritionists, and sports scientists, including both professionals and students. The study population included an intervention group (who received web-based nutritional and physical activity training) and a control group (who received no intervention), comprising in total 125 children aged 8 to 11 years. Due to COVID-19 mitigation measures, the control group was a comparative group observed during the prior school year (2019-2020). Anthropometric measurements were obtained before and after the intervention in both groups. Results: Due to a high dropout rate (n=57, 45.6%) because of the mitigation measures, there were 41 children in the intervention group and 27 in the control group. At baseline, the BMI z-score was 1.0 (SD 1.1) in the intervention group and 0.6 (SD 1.2) in the control group (P=.17). After the study period, the BMI z-score decreased by 0.06 (SD 0.21) in the intervention group, whereas it increased by 0.17 (SD 0.34) in the control group (P<.001). Comparing the change in BMI z-scores within BMI categories in the intervention group and control group revealed a statistically significant difference in the normal-weight children (P=.006). Further results showed that the decrease in BMI z-score was significant in the intervention group among both boys (P=.004) and girls (P=.01). Conclusions: A web-based intervention with combined nutritional education and physical activity training might be an adequate tool to lessen the enhanced increase in body weight during a pandemic. Therefore, additional studies with greater sample sizes and different locations are needed. As the implementation of such intervention programs is essential, further studies need to be established rapidly. %R 10.2196/50289 %U https://pediatrics.jmir.org/2024/1/e50289 %U https://doi.org/10.2196/50289 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e51366 %T Engagement, Acceptability, and Effectiveness of the Self-Care and Coach-Supported Versions of the Vira Digital Behavior Change Platform Among Young Adults at Risk for Depression and Obesity: Pilot Randomized Controlled Trial %A Weiner,Lauren S %A Crowley,Ryann N %A Sheeber,Lisa B %A Koegler,Frank H %A Davis,Jon F %A Wells,Megan %A Funkhouser,Carter J %A Auerbach,Randy P %A Allen,Nicholas B %+ Ksana Health, 2288 Alder Street, Eugene, OR, 97405, United States, 1 541 912 2883, lauren.weiner@ksanahealth.com %K depression %K behavioral activation %K digital health %K mental health %K behavior change %K mobile sensing %K anxiety %K health coaching %K mobile phone %D 2024 %7 19.9.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Adolescence and early adulthood are pivotal stages for the onset of mental health disorders and the development of health behaviors. Digital behavioral activation interventions, with or without coaching support, hold promise for addressing risk factors for both mental and physical health problems by offering scalable approaches to expand access to evidence-based mental health support. Objective: This 2-arm pilot randomized controlled trial evaluated 2 versions of a digital behavioral health product, Vira (Ksana Health Inc), for their feasibility, acceptability, and preliminary effectiveness in improving mental health in young adults with depressive symptoms and obesity risk factors. Methods: A total of 73 participants recruited throughout the United States were randomly assigned to use Vira either as a self-guided product (Vira Self-Care) or with support from a health coach (Vira+Coaching) for 12 weeks. The Vira smartphone app used passive sensing of behavioral data related to mental health and obesity risk factors (ie, activity, sleep, mobility, and language patterns) and offered users personalized insights into patterns of behavior associated with their daily mood. Participants completed self-reported outcome measures at baseline and follow-up (12 weeks). All study procedures were completed via digital communications. Results: Both versions of Vira showed strong user engagement, acceptability, and evidence of effectiveness in improving mental health and stress. However, users receiving coaching exhibited more sustained engagement with the platform and reported greater reductions in depression (Cohen d=0.45, 95% CI 0.10-0.82) and anxiety (Cohen d=0.50, 95% CI 0.13-0.86) compared to self-care users. Both interventions also resulted in reduced stress (Vira+Coaching: Cohen d=–1.05, 95% CI –1.57 to –-0.50; Vira Self-Care: Cohen d=–0.78, 95% CI –1.33 to –0.23) and were perceived as useful and easy to use. Coached users also reported reductions in sleep-related impairment (Cohen d=–0.51, 95% CI –1.00 to –0.01). Moreover, participants increased their motivation for and confidence in making behavioral changes, with greater improvements in confidence among coached users. Conclusions: An app-based intervention using passive mobile sensing to track behavior and deliver personalized insights into behavior-mood associations demonstrated feasibility, acceptability, and preliminary effectiveness for reducing depressive symptoms and other mental health problems in young adults. Future directions include (1) optimizing the interventions, (2) conducting a fully powered trial that includes an active control condition, and (3) testing mediators and moderators of outcome effects. Trial Registration: ClinicalTrials.gov NCT05638516; https://clinicaltrials.gov/study/NCT05638516 %M 39298763 %R 10.2196/51366 %U https://mental.jmir.org/2024/1/e51366 %U https://doi.org/10.2196/51366 %U http://www.ncbi.nlm.nih.gov/pubmed/39298763 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e56816 %T Development and Delivery of an Integrated Digital Health Care Approach for Children With Juvenile Idiopathic Arthritis: Usability Study %A Butler,Sonia %A Sculley,Dean %A Santos,Derek %A Gironès,Xavier %A Singh-Grewal,Davinder %A Coda,Andrea %K phone app %K smart watch %K juvenile idiopathic arthritis %K pain %K medication adherence %K physical activity %K integrated care %K medication %K development %K usability study %K chronic inflammatory disorder %K children %K child %K usability %K survey %K thematic analysis %K gamification %K modules %K web-based platform %K support %D 2024 %7 17.9.2024 %9 %J JMIR Pediatr Parent %G English %X Background: Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disorder with no cure. Most children are prescribed several medications aimed at controlling disease activity, managing symptoms, and reducing pain. Physical activity is also encouraged to retain musculoskeletal function. The primary determinants of treatment success are maintaining long-term adherence, ongoing monitoring by a pediatric rheumatologist, and involvement of an interdisciplinary team. To support these goals, a new digital intervention was developed, InteractiveClinics, which aimed to prompt children to take their medications, report pain levels, and increase their physical activity. Objective: This study aims to evaluate the usability of InteractiveClinics among children with JIA. Methods: As part of this pediatric cross-sectional study, 12 children were asked to wear a smartwatch for 2 weeks, which was synchronized to the InteractiveClinics phone app and web-based platform. Personalized notifications were sent daily to the watch and phone, to prompt and record medication adherence and pain level assessment. Physical activity was automatically recorded by the watch. At the end of the study, all children and parents completed a postintervention survey. Written comments were also encouraged to gain further feedback. Descriptive statistics were used to summarize the survey results, and all qualitative data underwent thematic analysis. Results: Twelve children aged 10 to 18 years (mean 14.2, SD 3.1 years; female: n=8, 66.7%) and 1 parent for each child (n=12; female: n=8, 66.7%) were enrolled in the study. Based on the highest and lowest agreement areas of the survey, most children and parents liked the smartwatch and web-based platform; they found it easy to learn and simple to use. They were also satisfied with the pain and physical activity module. However, usability and acceptability barriers that hindered uptake were identified in the phone app and medication module. Children required a unique in-app experience, and their suggestive improvements included more personalization within the app; simplification by removing all links not relevant to antirheumatic medications; flexibility in response times; improved conferment through gamification; additional comment fields for the input of more data, such as medication side effects or pain-related symptoms; more detailed graphical illustrations of the physical activity module, including a breakdown of metrics; and importantly, interconnections between modules, because medication adherence, pain levels, and physical activity can each influence the other. They were, overall, improving usefulness for children and parents. Conclusions: The usability of InteractiveClinics was positive. Children and parents liked the watch and web-based platform and were satisfied with the pain and physical activity module. However, children wanted a unique in-app experience through more personalization, simplification, flexibility, conferment, comment fields, graphical illustrations, a breakdown of metrics, and interconnections. Certainly, inclusions are needed to promote user adoption and advancement of new validated digital health interventions in pediatric rheumatology, to support the delivery of integrated care. Trial Registration: ANZCTR ACTRN12616000665437; https://tinyurl.com/mwwfje8r %R 10.2196/56816 %U https://pediatrics.jmir.org/2024/1/e56816 %U https://doi.org/10.2196/56816 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e56939 %T Designing a Culturally Relevant Digital Skin Cancer Prevention Intervention for Hispanic Individuals: Qualitative Exploration %A Niu,Zhaomeng %A Rivera,Yonaira M %A Lozada,Carolina %A Hudson,Shawna V %A Penedo,Frank J %A Manne,Sharon L %A Heckman,Carolyn J %+ Department of Health Informatics, Rutgers School of Health Professions, 675 Hoes Lane West, 826F, Piscataway, NJ, 08854, United States, 1 5093393076, zhaomeng.niu@rutgers.edu %K skin cancer %K prevention %K Hispanic %K sun protection %K skin self-examination %K intervention %K qualitative %K interviews %K health care provider %K community leader %K mobile-based %D 2024 %7 12.9.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: In the past 2 decades, melanoma incidence among Hispanic individuals has risen by 20%. The mortality rate of Hispanic individuals is higher than that for non-Hispanic White individuals. Skin cancer can largely be prevented with regular sun protection, and skin cancer outcomes can be improved through early detection, for example, by skin self-examination. Alarmingly, Hispanic individuals are less aware of the symptoms and harms of skin cancers, tend to have misperceptions regarding the risks and benefits of skin cancer prevention behaviors, and engage in less sun protection behaviors than non-Hispanic White individuals. Objective: This study aimed to use a community-engaged approach and conduct both group and individual interviews among Hispanic individuals and relevant key stakeholders to explore the potential design of a mobile-based skin cancer prevention intervention for Hispanic individuals. Methods: This study used a qualitative design (focus groups and individual interviews). Participants were recruited from local community organizations’ social media, local events, and contact lists (eg, email). Zoom interviews were conducted to examine whether Hispanic individuals would be interested in a mobile-based skin cancer intervention and to explore their preferences and suggestions to inform skin cancer prevention intervention design. Results: Five focus groups (2 in Spanish and 3 in English) among self-identified Hispanic individuals (n=34) and 15 semistructured, in-depth individual interviews among key stakeholders (health care providers and community leaders; eg, dermatologist, nurse practitioner, licensed social worker, and church leader) were conducted. The main themes and subthemes emerging from the group discussions and individual interviews were organized into the following categories: intervention platform, delivery frequency and format, message design, engagement plan, and activities. WhatsApp and Facebook were identified as suitable platforms for the intervention. Messages including short videos, visuals (eg, images and photographs), and simple texts messages were preferred. Recommendations for message design included personalized messages, personal stories and narratives, culturally relevant design (eg, incorporating family values), and community-trusted sources. Potential engagement and retention recommendations were also discussed. Additional details and exemplar quotes of each theme and subtheme are described. Conclusions: This study provides important insights and directions for the design of a mobile, digital skin cancer intervention to modify Hispanic individuals’ sun protection and skin self-examination behaviors to help improve skin cancer outcomes. Insights gathered from community leaders and health care providers provided valuable additions to the community-derived data. Leveraging popular digital platforms among Hispanic individuals such as WhatsApp or Facebook could be a promising approach to skin cancer prevention. Recommendations from the community included the use of concise videos, illustrative images, clear text messages, tailored communications, narratives featuring personal experiences, designs that reflect cultural significance, and information from sources that are trusted by the community, which provided useful strategies for future intervention design among Hispanic individuals. %M 39265165 %R 10.2196/56939 %U https://formative.jmir.org/2024/1/e56939 %U https://doi.org/10.2196/56939 %U http://www.ncbi.nlm.nih.gov/pubmed/39265165 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53727 %T Physical Activity Mobile App (CareFit) for Informal Carers of People With Dementia: Protocol for a Feasibility and Adaptation Study %A Egan,Kieren %A Macdonald,Bradley %A Hodgson,William %A Kirk,Alison %A Fawcett,Barbara %A Dunlop,Mark D %A Maguire,Roma %A Flynn,Greg %A Stott,Joshua %A Windle,Gill %+ Digital Health and Wellness Research Group (DHAWG), University of Strathclyde, Livingstone Tower, 26 Richmond St, Glasgow, G1 1XQ, United Kingdom, 44 141 548 3189, kieren.egan@strath.ac.uk %K carers %K dementia %K physical activity %K sedentary %K cross platform app %K caregivers %K mobile phone %D 2024 %7 12.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Physical activity is a critical component of both well-being and preventative health, reducing the risk of both chronic mental and physical conditions and early death. Yet, there are numerous groups in society who are not able to undertake as much physical activity as they would like to. This includes informal (unpaid) carers, with the United Kingdom national survey data suggesting that 81% would like to do more physical activity on a regular basis. There is a clear need to develop innovations, including digital interventions that hold implementation potential to support regular physical activity in groups such as carers. Objective: This study aims to expand and personalize a cross-platform digital health app designed to support regular physical activity in carers of people with dementia for a period of 8 weeks and evaluate the potential for implementation. Methods: The CareFit for dementia carers study was a mixed methods co-design, development, and evaluation of a novel motivational smartphone app to support home-based regular physical activity for unpaid dementia carers. The study was planned to take place across 16 months in total (September 1, 2022, to December 31, 2023). The first phase included iterative design sprints to redesign an initial prototype for widespread use, supported through a bespoke content management system. The second phase included the release of the “CareFit” app across Scotland through invitations on the Apple and Google stores where we aimed to recruit 50 carers and up to 20 professionals to support the delivery in total. Partnerships for the work included a range of stakeholders across charities, health and social care partnerships, physical activity groups, and carers’ organizations. We explored the implementation of CareFit, guided by both Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and the Complex Intervention Frameworks. Results: Project processes and outcomes were evaluated using mixed methods. The barriers and enablers for professional staff to signpost and use CareFit with clients were assessed through interviews or focus groups and round stakeholder meetings. The usability of CareFit was explored through qualitative interviews with carers and a system usability scale. We examined how CareFit could add value to carers by examining “in-app” data, pre-post questionnaire responses, and qualitative work, including interviews and focus groups. We also explored how CareFit could add value to the landscape of other online resources for dementia carers. Conclusions: Results from this study will contribute new knowledge including identifying (1) suitable pathways to identify and support carers through digital innovations; (2) future design of definitive studies in carer populations; and (3) an improved understanding of the Reach, Effectiveness, Adoption, Implementation, and Maintenance across a range of key stakeholders. International Registered Report Identifier (IRRID): DERR1-10.2196/53727 %M 39265159 %R 10.2196/53727 %U https://www.researchprotocols.org/2024/1/e53727 %U https://doi.org/10.2196/53727 %U http://www.ncbi.nlm.nih.gov/pubmed/39265159 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e56502 %T A Voice-Activated Device Exercise and Social Engagement Program for Older Adult–Care Partner Dyads: Pilot Clinical Trial and Focus Group Study Evaluating the Feasibility, Use, and Estimated Functional Impact of EngAGE %A Huisingh-Scheetz,Megan %A Nicholson III,Roscoe F %A Shervani,Saira %A Smith,Chelsea %A Danilovich,Margaret %A Finch,Laura %A Montoya,Yadira %A Hawkley,Louise C %+ Department of Medicine, University of Chicago, 5841 South Maryland Ave., Suite W707, MC 6098, Chicago, IL, 60637, United States, 1 7737028311, megan.huisingh-scheetz@bsd.uchicago.edu %K voice-activated device %K voice-activated devices %K frailty %K frail %K weak %K weakness %K technology %K activity %K physical activity %K exercise %K exercising %K caregiver %K caregivers %K caregiving %K caretaker %K caretakers %K caretaking %K care-giver %K care-givers %K care-giving %K care-taker %K care-takers %K care-taking %K gerontology %K geriatric %K geriatrics %K older adult %K older adults %K elder %K elderly %K older person %K older people %K ageing %K aging %K voice activation %K digital health %K technology %K exercises %K online exercises %K participatory design %K new devices %K health devices %K technology development %K mobile phone %D 2024 %7 12.9.2024 %9 Original Paper %J JMIR Aging %G English %X Background: Maintaining exercise is essential for healthy aging but difficult to sustain. EngAGE is a socially motivated exercise program delivered over a voice-activated device that targets older adult–care partner dyads. Objective: This 10-week pilot study aimed to assess EngAGE feasibility and use, obtain user experience feedback, and estimate potential impact on function. Methods: In total, 10 older adults aged ≥65 years were recruited from an independent living residence together with their self-identified care partners. EngAGE delivered National Institute on Aging Go4Life exercises to older adults daily, while care partners received progress reports and prompts to send encouraging messages that were read aloud by the device to the older adult. Older adults’ use was tracked, and physical function was assessed at baseline and follow-up. Follow-up focus group data provided qualitative feedback. Results: On average, participants completed 393.7 individual exercises over the 10-week intervention period or 39.4 exercises/wk (range 48-492, median 431, IQR 384-481, SD 112.4) without injury and used EngAGE on an average of 41 of 70 days or 4.1 d/wk (range 7-66, median 51, IQR 23-56, and SD 21.2 days). Mean grip strength increased nonsignificantly by 1.3 kg (preintervention mean 26.3 kg, SD 11.0; postintervention mean 27.6 kg, SD 11.6; P=.34), and 4 of 10 participants improved by a minimal clinically important difference (MCID) of 2.5 kg. Further, the time for 5-repeated chair stands significantly reduced by 2.3 seconds (preintervention mean 12, SD 3.6 s; postintervention mean 9.7, SD 2.7 s; P=.02), and 3 of 9 participants improved by an MCID of –2.3 seconds. Furthermore, 3-meter usual walk performance was brisk at baseline (mean 2.1, SD 0.4 s) and decreased by 0.1 seconds (postintervention 2, SD 0.4 s; P=.13), although 5 of 9 participants improved by a MCID of 0.05 m/s. Qualitative results showed perceived benefits, favored program features, and areas for improvement. Conclusions: We present a pilot study of a new voice-activated device application customized to older adult users that may serve as a guide to other technology development for older adults. Our pilot study served to further refine the application and to inform a larger trial testing EngAGE’s impact on functional outcomes, a necessary step for developing evidence-based technology tools. %M 39265155 %R 10.2196/56502 %U https://aging.jmir.org/2024/1/e56502 %U https://doi.org/10.2196/56502 %U http://www.ncbi.nlm.nih.gov/pubmed/39265155 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e48974 %T Toward Tailoring Just-in-Time Adaptive Intervention Systems for Workplace Stress Reduction: Exploratory Analysis of Intervention Implementation %A Suh,Jina %A Howe,Esther %A Lewis,Robert %A Hernandez,Javier %A Saha,Koustuv %A Althoff,Tim %A Czerwinski,Mary %+ Microsoft Research, 1 Microsoft Way, Redmond, WA, 98052, United States, 1 4254211584, jinsuh@microsoft.com %K workplace stress %K just-in-time %K just-in-time adaptive intervention %K JITAI %K engagement %K microintervention %K stress reduction %K psychotherapy %D 2024 %7 12.9.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Integrating stress-reduction interventions into the workplace may improve the health and well-being of employees, and there is an opportunity to leverage ubiquitous everyday work technologies to understand dynamic work contexts and facilitate stress reduction wherever work happens. Sensing-powered just-in-time adaptive intervention (JITAI) systems have the potential to adapt and deliver tailored interventions, but such adaptation requires a comprehensive analysis of contextual and individual-level variables that may influence intervention outcomes and be leveraged to drive the system’s decision-making. Objective: This study aims to identify key tailoring variables that influence momentary engagement in digital stress reduction microinterventions to inform the design of similar JITAI systems. Methods: To inform the design of such dynamic adaptation, we analyzed data from the implementation and deployment of a system that incorporates passively sensed data across everyday work devices to send just-in-time stress reduction microinterventions in the workplace to 43 participants during a 4-week deployment. We evaluated 27 trait-based factors (ie, individual characteristics), state-based factors (ie, workplace contextual and behavioral signals and momentary stress), and intervention-related factors (ie, location and function) across 1585 system-initiated interventions. We built logistical regression models to identify the factors contributing to momentary engagement, the choice of interventions, the engagement given an intervention choice, the user rating of interventions engaged, and the stress reduction from the engagement. Results: We found that women (odds ratio [OR] 0.41, 95% CI 0.21-0.77; P=.03), those with higher neuroticism (OR 0.57, 95% CI 0.39-0.81; P=.01), those with higher cognitive reappraisal skills (OR 0.69, 95% CI 0.52-0.91; P=.04), and those that chose calm interventions (OR 0.43, 95% CI 0.23-0.78; P=.03) were significantly less likely to experience stress reduction, while those with higher agreeableness (OR 1.73, 95% CI 1.10-2.76; P=.06) and those that chose prompt-based (OR 6.65, 95% CI 1.53-36.45; P=.06) or video-based (OR 5.62, 95% CI 1.12-34.10; P=.12) interventions were substantially more likely to experience stress reduction. We also found that work-related contextual signals such as higher meeting counts (OR 0.62, 95% CI 0.49-0.78; P<.001) and higher engagement skewness (OR 0.64, 95% CI 0.51-0.79; P<.001) were associated with a lower likelihood of engagement, indicating that state-based contextual factors such as being in a meeting or the time of the day may matter more for engagement than efficacy. In addition, a just-in-time intervention that was explicitly rescheduled to a later time was more likely to be engaged with (OR 1.77, 95% CI 1.32-2.38; P<.001). Conclusions: JITAI systems have the potential to integrate timely support into the workplace. On the basis of our findings, we recommend that individual, contextual, and content-based factors be incorporated into the system for tailoring as well as for monitoring ineffective engagements across subgroups and contexts. %M 39264703 %R 10.2196/48974 %U https://mental.jmir.org/2024/1/e48974 %U https://doi.org/10.2196/48974 %U http://www.ncbi.nlm.nih.gov/pubmed/39264703 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e58344 %T Effectiveness of a Parent-Based eHealth Intervention for Physical Activity, Dietary Behavior, and Sleep Among Preschoolers: Protocol for a Randomized Controlled Trial %A Zhou,Peng %A Song,Huiqi %A Lau,Patrick W C %A Shi,Lei %A Wang,Jingjing %+ Department of Sport, Physical Education and Health, Faculty of Arts and Social Sciences, Hong Kong Baptist University, Room AAB 1103, 11/F, Academic and Administration Building, Baptist University Road Campus, Kowloon Tong, Hong Kong, China (Hong Kong), 852 93774078, wclau@hkbu.edu.hk %K physical activity %K dietary behavior %K sleep %K electronic health %K eHealth %K preschoolers %K parenting %D 2024 %7 12.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Preschoolers’ lifestyles have become physically inactive and sedentary, their eating habits have become unhealthy, and their sleep routines have become increasingly disturbed. Parent-based interventions have shown promise to improve physical activity (PA), improve dietary behavior (DB), and reduce sleep problems among preschoolers. However, because of the recognized obstacles of face-to-face approaches (eg, travel costs and time commitment), easy access and lower costs make eHealth interventions appealing. Previous studies that examined the effectiveness of parent-based eHealth for preschoolers’ PA, DB, and sleep have either emphasized 1 variable or failed to balance PA, DB, and sleep modules and consider the intervention sequence during the intervention period. There is an acknowledged gap in parent-based eHealth interventions that target preschoolers raised in Chinese cultural contexts. Objective: This study aims to investigate the effectiveness of a parent-based eHealth intervention for PA, DB, and sleep problems among Chinese preschoolers. Methods: This 2-arm, parallel, randomized controlled trial comprises a 12-week intervention with a 12-week follow-up. A total of 206 parent-child dyads will be randomized to either an eHealth intervention group or a control group. Participants allocated to the eHealth intervention group will receive 12 interactive modules on PA, DB, and sleep, with each module delivered on a weekly basis to reduce the sequence effect on variable outcomes. The intervention is grounded in social cognitive theory. It will be delivered through social media, where parents can obtain valid and updated educational information, have a social rapport, and interact with other group members and facilitators. Participants in the control group will receive weekly brochures on PA, DB, and sleep recommendations from kindergarten teachers, but they will not receive any interactive components. Data will be collected at baseline, 3 months, and 6 months. The primary outcome will be preschoolers’ PA. The secondary outcomes will be preschoolers’ DB, preschoolers’ sleep duration, preschoolers’ sleep problems, parents’ PA, parenting style, and parental feeding style. Results: Parent-child dyads were recruited in September 2023. Baseline and posttest data collection occurred from October 2023 to March 2024. The follow-up data will be obtained in June 2024. The results of the study are expected to be published in 2025. Conclusions: The parent-based eHealth intervention has the potential to overcome the barriers of face-to-face interventions and will offer a novel approach for promoting a healthy lifestyle among preschoolers. If this intervention is found to be efficacious, the prevalence of unhealthy lifestyles among preschoolers may be alleviated at a low cost, which not only has a positive influence on the health of individuals and the well-being of the family but also reduces the financial pressure on society to treat diseases caused by poor lifestyle habits. Trial Registration: ClinicalTrials.gov NCT06025019; https://clinicaltrials.gov/study/NCT06025019 International Registered Report Identifier (IRRID): DERR1-10.2196/58344 %M 39264108 %R 10.2196/58344 %U https://www.researchprotocols.org/2024/1/e58344 %U https://doi.org/10.2196/58344 %U http://www.ncbi.nlm.nih.gov/pubmed/39264108 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e60023 %T Long-Term Glycemic Control Improvement After the Home and Self-Care Program for Patients With Type 1 Diabetes: Real-World–Based Cohort Study %A Koo,Dae-Jeong %A Moon,Sun-Joon %A Moon,Suhyeon %A Park,Se Eun %A Rhee,Eun-Jung %A Lee,Won-Young %A Park,Cheol-Young %+ Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea, 82 02 2001 1869, cydoctor@skku.edu %K type 1 diabetes %K structured education %K home health care %K glycated hemoglobin %K continuous glucose monitoring %K mobile phone %D 2024 %7 11.9.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: The prevalence of type 1 diabetes (T1D) is increasing worldwide, with a much higher proportion of adult patients. However, achieving stable glycemic control is difficult in these patients. Objective: After periodic implementation of structured education for patients with T1D through the Home and Self-Care Program, a pilot home health care project promoted by the Korean government, we evaluated the program’s effects on glycemic control. Methods: This study was conducted from April 2020 to March 2023. We analyzed 119 participants with T1D aged >15 years. Nursing and nutrition education were provided separately up to 4 times per year, with physician consultation up to 6 times per year. A distinguishing feature of this study compared with previous ones was the provision of remote support using a general-purpose smartphone communication app offered up to 12 times annually on an as-needed basis to enhance the continuity of in-person education effects. Patients were followed up on at average intervals of 3 months for up to 24 months. The primary end point was the mean difference in glycated hemoglobin (HbA1c) at each follow-up visit from baseline. For continuous glucose monitoring (CGM) users, CGM metrics were also evaluated. Results: The mean HbA1c level of study participants was 8.6% at baseline (mean duration of T1D 10.02, SD 16.10 y). The HbA1c level reduction in participants who received at least 1 structured educational session went from 1.63% (SD 2.03%; P<.001; adjustment model=1.69%, 95% CI 1.24%-2.13% at the first follow-up visit) to 1.23% (SD 1.31%; P=.01; adjustment model=1.28%, 95% CI 0.78%-1.79% at the eighth follow-up visit). In the adjustment model, the actual mean HbA1c values were maintained between a minimum of 7.33% (95% CI 7.20%-7.46% at the first follow-up visit) and a maximum of 7.62% (95% CI 7.41%-7.82% at the sixth follow-up visit). Among CGM users, after at least 1 session, the mean time in the target range was maintained between 61.59% (adjusted model, 95% CI 58.14%-65.03% at the second follow-up visit) and 54.7% (95% CI 50.92%-58.48% at the eighth follow-up visit), consistently staying above 54.7% (corresponding to an HbA1c level of <7.6%). The mean time below the target range (TBR) also gradually improved to the recommended range (≤4% for TBR of <70 mg/dL and ≤1% for TBR of <54 mg/dL). Conclusions: The Home and Self-Care Program protocol for glycemic control in patients with T1D is effective, producing significant improvement immediately and long-term maintenance effects, including on CGM indexes. %M 39259960 %R 10.2196/60023 %U https://www.jmir.org/2024/1/e60023 %U https://doi.org/10.2196/60023 %U http://www.ncbi.nlm.nih.gov/pubmed/39259960 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e48453 %T Evaluating the Impact of a Dutch Sexual Health Intervention for Adolescents: Think-Aloud and Semistructured Interview Study %A Metz,Gido %A Thielmann,Rosa R L C %A Roosjen,Hanneke %A Crutzen,Rik %+ Department of Health Promotion, Care and Public Health Research Institute, Maastricht University, PO Box 616, Maastricht, 6200 MD, Netherlands, 31 433882435, g.metz@maastrichtuniversity.nl %K web-based intervention %K eHealth %K engagement %K potential impact %K mixed methods %K evaluation %K acyclic behavior change diagram %K web analytics %K think-aloud method %K web-based %K user %K chlamydia %K behavior change %D 2024 %7 11.9.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Engagement with and the potential impact of web-based interventions is often studied by tracking user behavior with web analytics. These metrics do provide insights into how users behave, but not why they behave as such. Objective: This paper demonstrates how a mixed methods approach consisting of (1) a theoretical analysis of intended use, (2) a subsequent analysis of actual use, and (3) an exploration of user perceptions can provide insights into engagement with and potential impact of web-based interventions. This paper focuses on the exploration of user perceptions, using the chlamydia page of the Dutch sexual health intervention, Sense.info, as a demonstration case. This prevention-focused platform serves as the main source of sexual and reproductive health information (and care if needed) for young people aged 12-25 years in the Netherlands. Methods: First, acyclic behavior change diagrams were used to theoretically analyze the intended use of the chlamydia page. Acyclic behavior change diagrams display how behavior change principles are applied in an intervention and which subbehaviors and target behaviors are (aimed to be) influenced. This analysis indicated that one of the main aims of the page is to motivate sexually transmitted infection (STI) testing. Second, the actual use of the chlamydia page was analyzed with the web analytics tool Matomo. Despite the page’s aim of promoting STI testing, a relatively small percentage (n=4948, 14%) of the 35,347 transfers from this page were to the STI testing page. Based on these two phases, preliminary assumptions about use and impact were formulated. Third, to further explore these assumptions, a study combining the think-aloud method and semistructured interviews was executed with 15 young individuals aged 16-25 (mean 20, SD 2.5) years. Template analysis was used to analyze interview transcripts. Results: Participants found the information on the Sense.info chlamydia page reliable and would visit it mostly for self-diagnosis purposes if they experienced potential STI symptoms. A perceived facilitator for STI testing was the possibility to learn about the symptoms and consequences of chlamydia through the page. Barriers included an easily overlooked link to the STI testing page and the use of language not meeting the needs of participants. Participants offered suggestions for lowering the threshold for STI testing. Conclusions: The mixed methods approach used provided detailed insights into the engagement with and potential impact of the Sense.info chlamydia page, as well as strategies to further engage end users and increase the potential impact of the page. We conclude that this approach, which triangulates findings from theoretical analysis with web analytics and a think-aloud study combined with semistructured interviews, may also have potential for the evaluation of web-based interventions in general. %M 39259573 %R 10.2196/48453 %U https://formative.jmir.org/2024/1/e48453 %U https://doi.org/10.2196/48453 %U http://www.ncbi.nlm.nih.gov/pubmed/39259573 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 10 %N %P e51061 %T A Smart Water Bottle and Companion App (HidrateSpark 3) to Improve Bladder-Filling Compliance in Patients With Prostate Cancer Receiving Radiotherapy: Nonrandomized Trial of Feasibility and Acceptability %A Jin,William %A Montoya,Christopher %A Rich,Benjamin James %A Taswell,Crystal Seldon %A Noy,Miguel %A Kwon,Deukwoo %A Spieler,Benjamin %A Mahal,Brandon %A Abramowitz,Matthew %A Yechieli,Raphael %A Pollack,Alan %A Dal Pra,Alan %+ Department of Radiation Oncology, Jackson Memorial Hospital, 1611 NW 12th Avenue, Miami, FL, 33136, United States, 1 3055851111, willhjin@gmail.com %K digital therapeutics %K behavioral intervention %K digital health %K prostate cancer %K radiation %K smart water bottle %K companion app %K oncology %K prostate %K privacy %K radiation therapy %K bladder %K compliance %K smartphone-based behavioral intervention %K mobile phone %D 2024 %7 10.9.2024 %9 Original Paper %J JMIR Cancer %G English %X Background: Patients with prostate cancer undergoing radiation therapy (RT) need comfortably full bladders to reduce toxicities during treatment. Poor compliance is common with standard of care written or verbal instructions, leading to wasted patient value (PV) and clinic resources via poor throughput efficiency (TE). Objective: Herein, we assessed the feasibility and acceptability of a smartphone-based behavioral intervention (SBI) to improve bladder-filling compliance and methods for quantifying PV and TE. Methods: In total, 36 patients with prostate cancer were enrolled in a single-institution, closed-access, nonrandomized feasibility trial. The SBI consists of a fully automated smart water bottle and smartphone app. Both pieces alert the patient to empty his bladder and drink a personalized volume goal, based on simulation bladder volume, 1.25 hours before his scheduled RT. Patients were trained to adjust their volume goal and notification times to achieve comfortably full bladders. The primary end point was met if qualitative (QLC) and quantitative compliance (QNC) were >80%. For QLC, patients were asked if they prepared their bladders before daily RT. QNC was met if bladder volumes on daily cone-beam tomography were >75% of the simulation’s volume. The Service User Technology Acceptability Questionnaire (SUTAQ) was given in person pre- and post-SBI. Additional acceptability and engagement end points were met if >3 out of 5 across 4 domains on the SUTAQ and >80% (15/18) of patients used the device >50% of the time, respectively. Finally, the impact of SBI on PV and TE was measured by time spent in a clinic and on the linear accelerator (linac), respectively, and contrasted with matched controls. Results: QLC was 100% in 375 out of 398 (94.2%) total treatments, while QNC was 88.9% in 341 out of 398 (85.7%) total treatments. Of a total score of 5, patients scored 4.33 on privacy concerns, 4 on belief in benefits, 4.56 on satisfaction, and 4.24 on usability via SUTAQ. Further, 83% (15/18) of patients used the SBI on >50% of treatments. Patients in the intervention arm spent less time in a clinic (53.24, SEM 1.71 minutes) compared to the control (75.01, SEM 2.26 minutes) group (P<.001). Similarly, the intervention arm spent less time on the linac (10.67, SEM 0.40 minutes) compared to the control (14.19, SEM 0.32 minutes) group (P<.001). Conclusions: This digital intervention trial showed high rates of bladder-filling compliance and engagement. High patient value and TE were feasibly quantified by shortened clinic times and linac usage, respectively. Future studies are needed to evaluate clinical outcomes, patient experience, and cost-benefit. Trial Registration: ClinicalTrials.gov NCT04946214; https://www.clinicaltrials.gov/study/NCT04946214 %M 39255484 %R 10.2196/51061 %U https://cancer.jmir.org/2024/1/e51061 %U https://doi.org/10.2196/51061 %U http://www.ncbi.nlm.nih.gov/pubmed/39255484 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e50356 %T Real-World Outcomes of a Digital Behavioral Coaching Intervention to Improve Employee Health Status: Retrospective Observational Study %A Abdul Aziz,Amani Fadzlina %A Ong,Tiffanie %+ Naluri Hidup Sdn Bhd, 22, Persiaran Damansara Endah, Bukit Damansara, Kuala Lumpur, 50490, Malaysia, 60 123072922, tiffanie@naluri.life %K digital behavioral coaching %K chronic disease management %K digital health %K mHealth %K workplace interventions %K mobile phone %D 2024 %7 10.9.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Chronic noncommunicable diseases (NCDs) account for major disability and premature mortality worldwide, with low- and middle-income countries being disproportionately burdened. Given the negative impact of NCDs on employee performance and work productivity, there is a rising need for stakeholders to identify effective workplace solutions that can improve employee health outcomes. As the workplace becomes more dispersed post pandemic, digital behavioral coaching offers a scalable, personalized, and cost-effective method of managing chronic disease risk factors among employees. Objective: This study aimed to retrospectively evaluate the impact of a digital behavioral coaching program on year-to-year changes in employee health status in a cohort of Indonesian employees. Methods: This retrospective real-world exploratory analysis of secondary health data followed 774 employees of an Indonesian company who completed company-sponsored health screenings between 2021 and 2022 and were given access to Naluri (Naluri Hidup Sdn Bhd), a holistic digital therapeutics platform offering digital behavioral health coaching and self-help tools. Participants were retrospectively classified as those who received active coaching (n=177), passive coaching (n=108), and no coaching (n=489). Linear mixed-effects models were used to evaluate the year-to-year changes in health outcomes across the 3 employee groups, with post hoc analyses evaluating within-group differences between the 2 time points and between-group differences at follow-up. Results: Significant time×group interaction effects were detected for body weight, BMI, hemoglobin A1c, low-density lipoprotein, total cholesterol, and systolic and diastolic blood pressure. Post hoc pairwise comparisons revealed significant improvements in hemoglobin A1c (mean difference [Mdiff]=–0.14, P=.008), high-density lipoprotein (Mdiff=+2.14, P<.001), and total cholesterol (Mdiff=–11.45, P<.001) for employees in the Active Coaching group between 2021 and 2022, with the other 2 groups reporting deteriorations in multiple health outcomes throughout the 2 time points. At follow-up, those who received active coaching between 2021 and 2022 reported significantly lower body weight (P<.001), BMI (P=.001), low-density lipoprotein (P=.045), and total cholesterol (P<.001) than the No Coaching group. Conclusions: This study demonstrates real-world outcomes and implications supporting the use of workplace digital behavioral coaching in improving employee health status. Given the rising burden of NCDs in the Southeast Asian region, our findings underscore the role that workplace digital health interventions can play in preventing and managing chronic disease risk factors. %M 39255013 %R 10.2196/50356 %U https://mhealth.jmir.org/2024/1/e50356 %U https://doi.org/10.2196/50356 %U http://www.ncbi.nlm.nih.gov/pubmed/39255013 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e49362 %T Comparing the Efficacy of 2 WeChat Mini Programs in Reducing Nonmarital Heterosexual Contact by Male Factory Workers: Randomized Controlled Trial %A Zhang,Kechun %A Cao,Bolin %A Fang,Yuan %A Liang,Xue %A Ye,Danhua %A Chen,Ya Qi %A Zhong,Ruilan %A Cao,He %A Hu,Tian %A Li,Ting %A Cai,Yong %A Zou,Huachun %A Wang,Zixin %+ Centre for Health Behaviours Research, The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Room 508, School of Public Health, Prince of Wales Hospital, 30-32 Ngan Shing Street, Hong Kong, China (Hong Kong), 852 22528740, wangzx@cuhk.edu.hk %K nonmarital heterosexual contacts %K male factory workers %K WeChat mini program %K randomized controlled trial %K China %K mobile phone %D 2024 %7 9.9.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Male factory workers in China are vulnerable to HIV transmission. Commercial and nonmarital noncommercial contacts are the driving forces of heterosexual HIV transmission among male factory workers in China. There is a lack of effective HIV interventions for male factory workers in China. Objective: The primary objective of this randomized controlled trial was to compare the efficacy of an enhanced versus the standard version of a WeChat mini program in reducing sexual intercourse with nonregular female sex partners and female sex workers among male factory workers in Shenzhen, China. Methods: A nonblinded 2-arm parallel randomized controlled trial was conducted between December 2021 and April 2023. Participants were adult male factory workers in Shenzhen who had access to a smartphone and WeChat. Those who had oral or anal sex with a man or self-reported as HIV positive were excluded. A total of 247 participants were randomly assigned to the intervention group (n=125, 50.6%) or the control group (n=122, 49.4%); 221 (89.5%) and 220 (89.1%) completed follow-up surveys at T1 (6 months after completion of the interventions) and T2 (6 months after T1). Participants in the control group had access to the standard WeChat mini program that provided basic HIV-related knowledge and information about local free HIV testing services. Participants in the intervention group had access to the enhanced WeChat mini program. The enhanced mini program covered all the information in the standard mini program. In addition, the enhanced mini program assessed users’ behaviors and invited users to watch different web-based videos on reducing nonmarital sexual contacts and promoting HIV testing based on their behavioral characteristics at months 0 and 1. The videos were developed based on in-depth interviews with male factory workers. Intention-to-treat analysis was used for outcome analyses. Multiple imputation was used to replace missing outcome values at T1 and T2. Results: At T1, fewer participants in the intervention group reported sexual intercourse with a nonregular female sex partner in the past 6 months compared with the control group (1/125, 0.8% vs 8/122, 6.6%; relative risk=0.12, 95% CI 0.02-0.96; P=.02). However, there were no between-group differences in sexual intercourse with a nonregular female sex partner at T2 (10/125, 8% vs 14/122, 11.5%; P=.36) or sexual intercourse with a female sex worker at T1 (2/125, 1.6% vs 2/122, 1.6%; P=.98) or T2 (8/125, 6.4% vs 8/122, 6.6%; P=.96). Conclusions: The enhanced WeChat mini program was more effective than the standard WeChat mini program in reducing sexual intercourse with nonregular female sex partners among male factory workers in the short term but not in the longer term. Improvements should be made to the WeChat mini program before implementation. Trial Registration: ClinicalTrials.gov NCT05811611; https://clinicaltrials.gov/study/NCT05811611 %M 39250213 %R 10.2196/49362 %U https://www.jmir.org/2024/1/e49362 %U https://doi.org/10.2196/49362 %U http://www.ncbi.nlm.nih.gov/pubmed/39250213 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e56580 %T The Physical and Psychological Effects of Telerehabilitation-Based Exercise for Patients With Nonspecific Low Back Pain: Prospective Randomized Controlled Trial %A Shi,Weihong %A Zhang,Yuhang %A Bian,Yanyan %A Chen,Lixia %A Yuan,Wangshu %A Zhang,Houqiang %A Feng,Qiyang %A Zhang,Huiling %A Liu,Diana %A Lin,Ye %K nonspecific low back pain %K telerehabilitation %K physical therapy %K low back pain %K back pain %K psychological %K exercise %K randomized controlled trial %K efficacy %K medical infrastructure %K pain intensity %K quality of life %K health survey %K therapeutic %K mobile phone %D 2024 %7 6.9.2024 %9 %J JMIR Mhealth Uhealth %G English %X Background: Physical therapy has demonstrated efficacy in managing nonspecific low back pain (NLBP) among patients. Nevertheless, the prevalence of NLBP poses a challenge, as the existing medical infrastructure may be insufficient to care for the large patient population, particularly in geographically remote regions. Telerehabilitation emerges as a promising method to address this concern by offering a method to deliver superior medical care to a greater number of patients with NLBP. Objective: The purpose of this study is to demonstrate the physical and psychological effectiveness of a user-centered telerehabilitation program, consisting of a smartphone app and integrated sensors, for patients with NLBP. Methods: This was a single-center, prospective, randomized controlled trial for individuals with NLBP for a duration exceeding 3 months. All participants were assigned randomly to either the telerehabilitation-based exercise group (TBEG) or the outpatient-based exercise group (OBEG). All participants completed a 30-minute regimen of strength and stretching exercises 3 times per week, for a total of 8 weeks, and were required to complete assessment questionnaires at 0, 2, 4, and 8 weeks. The TBEG completed home-based exercises and questionnaires using a telerehabilitation program, while the OBEG completed them in outpatient rehabilitation. The Oswestry Disability Index (ODI) served as the primary outcome measure, assessing physical disability. Secondary outcomes included the Numeric Pain Rating Scale, Fear-Avoidance Beliefs Questionnaire, and 36-item Short-Form Health Survey. Results: In total, 54 of 129 eligible patients were enrolled and randomly assigned to the study. The completion of all the interventions and assessments in the TBEG and OBEG was 89% (24/27) and 81% (22/27). The findings indicate that no statistical significance was found in the difference of ODI scores between the TBEG and the OBEG at 2 weeks (mean difference −0.91; odds ratio [OR] 0.78, 95% CI −5.96 to 4.14; P=.72), 4 weeks (mean difference −3.80; OR 1.33, 95% CI −9.86 to −2.25; P=.21), and 8 weeks (mean difference −3.24; OR 0.92, 95% CI −8.65 to 2.17; P=.24). The improvement of the ODI in the TBEG (mean −16.42, SD 7.30) and OBEG (mean −13.18, SD 8.48) was higher than 10 after an 8-week intervention. No statistically significant differences were observed between the 2 groups at the 8-week mark regarding the Fear-Avoidance Beliefs Questionnaire (mean difference 8.88; OR 1.04, 95% CI −2.29 to 20.06; P=.12) and Numeric Pain Rating Scale (mean difference −0.39; OR 0.44, 95% CI −2.10 to 1.31; P=.64). In the subgroup analysis, there was no statistically significant difference in outcomes between the 2 groups. Conclusions: Telerehabilitation interventions demonstrate comparable therapeutic efficacy for individuals with NLBP when compared to conventional outpatient-based physical therapy, yielding comparable outcomes in pain reduction and improvement in functional limitations. Trial Registration: Chinese Clinical Trial Registry ChiCTR2300068984; https://www.chictr.org.cn/showproj.html?proj=189852 %R 10.2196/56580 %U https://mhealth.jmir.org/2024/1/e56580 %U https://doi.org/10.2196/56580 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53512 %T Investigating Patient Perspectives on Using eHealth Technologies for the Self-Management of Inflammatory Bowel Disease: Mixed Methods Study %A Hermsen,Sander %A Tump,Danielle %A Wentink,Eva %A Duijvestein,Marjolijn %+ OnePlanet Research Centre, Precision Health and Nutrition Group, Bronland 10, Wageningen, 6708 WH, Netherlands, 31 317 791 009, sander.hermsen@imec.nl %K information and communication technology %K ICT %K self-management %K inflammatory bowel disease %K IBD %K smart toilet seat %K mobile phone %D 2024 %7 6.9.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Inflammatory bowel disease (IBD) poses significant challenges for patients, requiring continuous monitoring and self-management to improve quality of life. Objective: This study aims to investigate the viewpoints of individuals living with IBD on the use of information and communication technology (ICT) for the self-management of their condition, with a particular focus on the concept of a “smart” toilet seat as an example of ICT for IBD self-management. Methods: We conducted an analysis of questionnaire responses obtained from 724 participants. They were encouraged to share their use cases and identify any perceived barriers associated with ICT adoption for managing their condition. To assess their responses, we used descriptive quantitative analysis, summative content analysis, and thematic qualitative analysis. We combined these results in an epistemic network analysis to look for meaningful patterns in the responses. Results: Of the 724 participants, more than half (n=405, 55.9%) were already using various forms of ICT for IBD self-management. The primary factor influencing their use of ICT was their affinity for interacting with technology. Distinct differences emerged between individuals who were using ICT and those who were not, particularly regarding their perceived use cases and concerns. Conclusions: This study provides valuable insights into the perspectives of individuals with IBD on the use of ICT for self-management. To facilitate wider adoption, addressing privacy concerns, ensuring data security, and establishing reliable ICT integration will be critical. %M 39240663 %R 10.2196/53512 %U https://www.jmir.org/2024/1/e53512 %U https://doi.org/10.2196/53512 %U http://www.ncbi.nlm.nih.gov/pubmed/39240663 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e54909 %T Developing a Youth-Led Digital Hypertension Education Intervention for Adults With Hypertension: Qualitative Study on Refinement and Acceptability %A Heinert,Sara W %A Guzman-Baez,Kelvin %A Aamir,Affan %A Penugonda,Ananya %A Crabtree,Benjamin F %A Greene,Kathryn %A Heckman,Carolyn J %A Levy,Phillip %A Strickland,Pamela Ohman %A Hudson,Shawna V %+ Department of Emergency Medicine, Rutgers Robert Wood Johnson Medical School, One Robert Wood Johnson Place, New Brunswick, NJ, 08901, United States, 1 732 235 7872, sara.heinert@rutgers.edu %K hypertension %K adolescents %K adults %K emergency department %K digital health intervention %K dyad intervention %K intervention development %K qualitative research %K youth %K adolescent %K teen %K teens %K teenager %K teenagers %K adult %K youth-led %K digital health %K health education %K refinement %K acceptability %K USA %K United States %K care navigation %K effectiveness %K formative study %K prototype %K self-guided %K online module %K online modules %K engagement %K blood pressure %K health knowledge %K health promotion %K nutrition education %K support intervention %K support %K supports %D 2024 %7 6.9.2024 %9 Short Paper %J JMIR Form Res %G English %X Background: Hypertension affects one-third of adults in the United States and is the leading risk factor for death. Underserved populations are seen disproportionately in the emergency department (ED) and tend to have worse blood pressure (BP) control. For adults, a lack of hypertension knowledge is a common barrier to hypertension control, while social support is a strong facilitator, and providing information that is culturally sensitive and relevant is especially important in this context. The youth experience increased confidence when given the responsibility to provide health education and care navigation to others. As such, we planned a randomized controlled trial (RCT) for the effectiveness of a digital youth-led hypertension education intervention for adult patients in the ED with hypertension, focusing on change in BP and hypertension knowledge. Objective: In preparation for an RCT, we conducted a formative study to determine acceptable and easily comprehensible ways to present hypertension information to adults with hypertension and optimal ways to engage youth to support adults on how to achieve better hypertension control. Methods: After creating an intervention prototype with 6 weekly self-guided hypertension online modules, we recruited 12 youth (adolescents, aged 15-18 years) for 3 focus groups and 10 adult ED patients with hypertension for individual online interviews to garner feedback on the prototype. After completing a brief questionnaire, participants were asked about experiences with hypertension, preferences for a hypertension education intervention, and acceptability, feasibility, obstacles, and solutions for intervention implementation with youth and adults. The moderator described and showed participants the prototyped intervention process and materials and asked for feedback. Questionnaire data were descriptively summarized, and qualitative data were analyzed using the template organizing style of analysis by 3 study team members. Results: Participants showed great interest in the intervention prototype, thought their peers would find it acceptable, and appreciated its involvement of youth. Youth with family members with hypertension reported that their family members need more support for their hypertension. Youth suggested adding more nutrition education activities to the intervention, such as a sodium tracker and examples of high-sodium foods. Adults discussed the need for a hypertension support intervention for themselves and the expected benefits to youth. They mentioned the overwhelming amount of hypertension information available and appreciated the intervention’s concise content presentation. They suggested adding more mental health and smoking cessation resources, information about specific hypertension medications, and adding active links for health care information. Conclusions: Based on focus groups and interviews with participants, a youth-led digital hypertension intervention is an acceptable strategy to engage both adults with hypertension and youth. Incorporating participant suggestions into the intervention may improve its clarity, engagement, and impact when used in a subsequent RCT. %M 39240662 %R 10.2196/54909 %U https://formative.jmir.org/2024/1/e54909 %U https://doi.org/10.2196/54909 %U http://www.ncbi.nlm.nih.gov/pubmed/39240662 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e56396 %T Breaking Down Barriers to a Suicide Prevention Helpline: Web-Based Randomized Controlled Trial %A Van der Burgt,Margot C A %A Mérelle,Saskia %A Brinkman,Willem-Paul %A Beekman,Aartjan T F %A Gilissen,Renske %K barrier reduction intervention %K suicidal ideation %K self-help %K suicide prevention helpline %K randomized controlled trial %K help-seeking %K suicide %K RCT %K self-test %K effectiveness %K prevention %K middle-aged %K behavioral %K attitudinal %K website visitors %K website visitor %K website %K men %K suicide prevention %D 2024 %7 5.9.2024 %9 %J JMIR Ment Health %G English %X Background: Every month, around 3800 people complete an anonymous self-test for suicidal thoughts on the website of the Dutch suicide prevention helpline. Although 70% score high on the severity of suicidal thoughts, <10% navigate to the web page about contacting the helpline. Objective: This study aimed to test the effectiveness of a brief barrier reduction intervention (BRI) in motivating people with severe suicidal thoughts to contact the suicide prevention helpline, specifically in high-risk groups such as men and middle-aged people. Methods: We conducted a fully automated, web-based, randomized controlled trial. Respondents with severe suicidal thoughts and little motivation to contact the helpline were randomly allocated either to a brief BRI, in which they received a short, tailored message based on their self-reported barrier to the helpline (n=610), or a general advisory text (care as usual as the control group: n=612). Effectiveness was evaluated using both behavioral and attitudinal measurements. The primary outcome measure was the use of a direct link to contact the helpline after completing the intervention or control condition. Secondary outcomes were the self-reported likelihood of contacting the helpline and satisfaction with the received self-test. Results: In total, 2124 website visitors completed the Suicidal Ideation Attributes Scale and the demographic questions in the entry screening questionnaire. Among them, 1222 were randomized into the intervention or control group. Eventually, 772 respondents completed the randomized controlled trial (intervention group: n=369; control group: n=403). The most selected barrier in both groups was “I don’t think that my problems are serious enough.” At the end of the trial, 33.1% (n=122) of the respondents in the intervention group used the direct link to the helpline. This was not significantly different from the respondents in the control group (144/403, 35.7%; odds ratio 0.87, 95% CI 0.64‐1.18, P=.38). However, the respondents who received the BRI did score higher on their self-reported likelihood of contacting the helpline at a later point in time (B=0.22, 95% CI 0.12‐0.32, P≤.001) and on satisfaction with the self-test (B=0.27, 95% CI 0.01‐0.53, P=.04). For male and middle-aged respondents specifically, the results were comparable to that of the whole group. Conclusions: This trial was the first time the helpline was able to connect with high-risk website visitors who were hesitant to contact the helpline. Although the BRI could not ensure that those respondents immediately used the direct link to the helpline at the end of the trial, it is encouraging that respondents indicated that they were more likely to contact the helpline at a later point in time. In addition, this low-cost intervention provided greater insight into the perceived barriers to service. Follow-up research should be focused on identifying the added value of other components (eg, video or photo material) in the BRI and increasing its effectiveness, especially for men and middle-aged people. Trial Registration: ClinicalTrials.gov NCT05458830; https://clinicaltrials.gov/study/NCT05458830 International Registered Report Identifier (IRRID): RR2-10.2196/41078 %R 10.2196/56396 %U https://mental.jmir.org/2024/1/e56396 %U https://doi.org/10.2196/56396 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e59222 %T Digitizing Survivorship Care Plans Through the POST-Treatment Health Outcomes of Cancer Survivors (POSTHOC) Mobile App: Protocol for a Phase II Randomized Controlled Trial %A Chung,Kaitlin H %A Youngblood,Shari M %A Clingan,Carin L %A Deighton,Dana C %A Jump,Virginia A %A Manuweera,Thushini %A McGeorge,Nicolette M %A Renn,Cynthia L %A Rosenblatt,Paula Y %A Winder,Aaron T %A Zhu,Shijun %A Kleckner,Ian R %A Kleckner,Amber S %+ Department of Pain and Translational Symptom Science, University of Maryland School of Nursing, 655 W. Lombard Ave., Baltimore, MD, 21201, United States, 1 410 706 5961, amber.kleckner@umaryland.edu %K mobile health %K mHealth %K symptoms %K clinical trial %K posttreatment %K oncology %K mobile phone %D 2024 %7 5.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Survivorship care plans (SCPs) are provided at the completion of cancer treatment to aid in the transition from active treatment to long-term survivorship. They describe the details of a patient’s diagnosis and treatment and offer recommendations for follow-up appointments, referrals, and healthy behaviors. The plans are currently paper-based and become outdated as soon as a patient’s health status changes. There is a need to digitize these plans to improve their accessibility, modifiability, and longevity. With current technology, SCPs can be linked to mobile devices and activity trackers so that patients can track health behaviors and compare them to their clinical goals, taking charge of their own health. Objective: A mobile app, POSTHOC (POST-Treatment Health Outcomes of Cancer Survivors), that digitizes the SCP was developed, with goals of integrating it with wearable technologies and electronic medical records. Herein, we are conducting a randomized controlled trial that evaluates the POSTHOC app versus the traditional SCP on total symptom burden in the early posttreatment period. Methods: We will recruit 54 patients who have recently completed curative therapy for cancer (any type) in person and remotely. They will be randomized 2:1, POSTHOC:usual care (unblinded). Those randomized to the POSTHOC group will receive their SCP via the app and will choose to focus on nutrition or exercise for the duration of the study based on their individual plan and personal preferences. Those randomized to the control group will get a paper-based plan. At baseline, 6 weeks, and 12 weeks, we will evaluate patient-reported outcomes, including total symptom burden (web-based questionnaire), diet (24-hour Automated Self-Administered [ASA24]), and physical activity (Fitbit Charge 6 [Google LLC]). We will also collect quantitative and qualitative feedback on the usability of the app from those in the POSTHOC arm to improve the app for future implementation studies, with a specific focus on patient-provider communication. For feasibility, we will calculate the percentage of patients who used the POSTHOC app at least 3 times per week. We will use linear mixed models to evaluate the effects of the POSTHOC app versus those of usual care on other outcomes at weeks 6 and 12. Results: This trial is open to accrual in the University of Maryland Medical System as of March 2024, and as of July 3, 2024, a total of 20 participants have consented. Conclusions: This study is among the first to digitize the SCP in a mobile app and test the effects of a mobile health–delivered behavioral health intervention on symptom burden in cancer survivors. Our results will provide evidence about the effects of health self-management on symptoms. This knowledge will be integral to larger randomized controlled studies, integration with the electronic medical record, and nationwide implementation. Trial Registration: ClinicalTrials.gov NCT05499663; https://clinicaltrials.gov/ct2/show/NCT05499663 International Registered Report Identifier (IRRID): DERR1-10.2196/59222 %M 39235855 %R 10.2196/59222 %U https://www.researchprotocols.org/2024/1/e59222 %U https://doi.org/10.2196/59222 %U http://www.ncbi.nlm.nih.gov/pubmed/39235855 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e55079 %T Ecological Momentary Intervention to Replace Sedentary Time With Physical Activity to Improve Executive Function in Midlife and Older Latino Adults: Pilot Randomized Controlled Trial %A Bronas,Ulf G %A Marquez,David X %A Fritschi,Cynthia %A Petrarca,Katherine %A Kitsiou,Spyros %A Ajilore,Olu %A Tintle,Nathan %+ School of Nursing, Columbia University, 560 W 168th St, New York, NY, 10032, United States, 1 2123055756, ub2154@cumc.columbia.edu %K sedentary time %K physical activity %K cognition %K older adults %K Latinos %K mobile phone %D 2024 %7 5.9.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Exercise interventions often improve moderate to vigorous physical activity, but simultaneously increase sedentary time due to a compensatory resting response. A higher level of sedentary time is associated with a lower level of executive function, while increased moderate to vigorous physical activity is associated with improved global cognition and working memory among Latino adults. Latino adults are the fastest-growing minority group in the United States and are at high risk for cognitive decline, spend more time sedentary compared to non-Hispanic populations, and engage in low levels of physical activity. Interventions that are culturally appropriate for Latino adults to replace sedentary time with physical activity are critically needed. Objective: This study aims to develop and test the feasibility and acceptability of an ecological momentary intervention (EMI; delivered in real time) that is individually designed to replace sedentary time with physical activity in Latino adults. Methods: This pilot study randomized 39 (n=26, 67% female; mean age 61, SD 5.8 years) community-dwelling, Spanish-speaking Latino adults (1:1 allocation) to either a 6-week EMI program designed to replace sitting time with physical activity (20/39, 51%) or physical activity guidelines education (19/39, 49%). The program was conducted on the web and in Spanish. The intervention was individualized based on individual interview responses. The intervention included the use of a Fitbit activity monitor, weekly didactic phone meetings, interactive tools (SMS text messages), and coach-delivered feedback. Feasibility and acceptability were assessed via study satisfaction (Likert scales), motivation (ecological momentary assessment), retention, and compliance. Sedentary time and physical activity were assessed via 7-day actigraphy. Cognitive performance was assessed via the trail making test part A and B (part B=executive function) and via the National Institutes of Health Toolbox remote cognitive assessment. Statistical analysis included a linear model on change score from baseline, adjusting for age, sex, and education, emphasizing effect size. Results: Participant satisfaction with EMI was high (9.4/10), with a high degree of motivation to replace sitting time with physical activity (9.8/10). The intervention compliance rate was 79% with low difficulty using the Fitbit (1.7/10). Weekly step count increased in the intervention group by 5543 steps (group difference: d=0.54; P=.05) and sedentary time decreased by a mean 348 (SD 485) minutes (group difference: d=0.47; P=.24) compared to controls, with moderately strong effect sizes. The trail making test part B improved in the intervention group (mean –35.26, SD 60.35 seconds), compared to the control group (mean 7.19, SD 46 seconds; group difference: d=0.74; P=.01). No group differences were observed in other cognitive measures. Conclusions: An individualized EMI designed for midlife and older Latino adults has the potential to replace sitting time with physical activity and improve executive functioning. The intervention was feasible and well received with a high degree of satisfaction. Trial Registration: ClinicalTrials.gov NCT04507464; https://tinyurl.com/44c4thk5 %M 39235836 %R 10.2196/55079 %U https://www.jmir.org/2024/1/e55079 %U https://doi.org/10.2196/55079 %U http://www.ncbi.nlm.nih.gov/pubmed/39235836 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e54051 %T The Relationship Between Symptom Change and Use of a Web-Based Self-Help Intervention for Parents of Children With Externalizing Behavior Disorders: Exploratory Study %A Wähnke,Laura %A Dose,Christina %A Klemp,Marie-Theres %A Mühlenmeister,Judith %A Plück,Julia %A Döpfner,Manfred %+ School for Child and Adolescent Cognitive Behavior Therapy, Faculty of Medicine and University Hospital Cologne, The University of Cologne, Pohligstr 9, Cologne, 50969, Germany, 49 47887774, laura.waehnke@uni-koeln.de %K web-based self-help %K eHealth %K parent management training %K externalizing symptom %K ADHD %K attention-deficit hyperactivity disorder %K self-help %K use %K child %K children %K parent %K parents %K management %K management training %K symptom %K symptoms %K caregiver %K ODD %K oppositional defiant disorder %K treatment %K web-based %K caregivers %K longitudinal data %D 2024 %7 4.9.2024 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Web-based self-help (WASH) has been found to be effective in the treatment of child externalizing behavior disorders. However, research on the associations of caregivers’ use of WASH and symptom changes of child externalizing behaviors is lacking. Objective: This study examined the longitudinal and reciprocal associations between the use of WASH by caregivers of children with externalizing behavior disorders and their children’s externalizing behavior symptoms. Methods: Longitudinal data of 276 families from 2 intervention conditions of a randomized controlled trial (either unguided or supported by a therapist over the phone) were analyzed. Caregiver- and clinician-rated child externalizing behavior symptoms were assessed before (T1), in the middle (T2), and after the 6-month WASH intervention (T3). Additionally, 2 indicators of the caregivers’ use of the WASH intervention were considered: number of log-ins (frequency) and the percentage of completed material (intensity). Associations of caregivers’ use during early (T1-T2) and late (T2-T3) treatment with child externalizing behavior symptoms were analyzed using path analyses (structural equation modeling). Results: Frequency and intensity of use were higher during the first 3 months than during the next 3 months of the intervention period. The number of log-ins at early treatment was significantly but weakly associated with caregiver-reported child externalizing behavior symptoms in the long term (T3). Moreover, caregiver-reported child externalizing severity at T2 predicted the number of log-ins in the late treatment. The results were not replicated when considering the percentage of completed material as a measure of use or when considering clinician ratings of child externalizing behavior symptoms. Conclusions: The findings provide the first, albeit weak, evidence for longitudinal associations between caregivers’ use of WASH and improvements in caregiver-rated child externalizing behavior symptoms. However, as the associations were rather weak and could not be replicated across different rater perspectives and operationalizations of use, further research is needed to better understand these relations and their interplay with other putative influence factors (eg, quality of the implementation of the interventions, changes in parenting behaviors). Trial Registration: German Clinical Trials Register DRKS00013456; https://www.drks.de/DRKS00013456 International Registered Report Identifier (IRRID): RR2-10.1186/s12888-020-2481-0 %M 39231431 %R 10.2196/54051 %U https://pediatrics.jmir.org/2024/1/e54051 %U https://doi.org/10.2196/54051 %U http://www.ncbi.nlm.nih.gov/pubmed/39231431 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e58627 %T Best Practices for Designing and Testing Behavioral and Health Communication Interventions for Delivery in Private Facebook Groups: Tutorial %A Pagoto,Sherry %A Lueders,Natalie %A Palmer,Lindsay %A Idiong,Christie %A Bannor,Richard %A Xu,Ran %A Ingels,Spencer %+ Department of Allied Health Sciences, University of Connecticut, Storrs, CT, United States, 1 860 486 5917, sherry.pagoto@uconn.edu %K social media %K Facebook %K behavioral intervention %K health communication %K Facebook groups %D 2024 %7 4.9.2024 %9 Tutorial %J JMIR Form Res %G English %X Facebook, the most popular social media platform in the United States, is used by 239 million US adults, which represents 71% of the population. Not only do most US adults use Facebook but they also spend an average of 40 minutes per day on the platform. Due to Facebook’s reach and ease of use, it is increasingly being used as a modality for delivering behavioral and health communication interventions. Typically, a Facebook-delivered intervention involves creating a private group to deliver intervention content for participants to engage with asynchronously. In many interventions, a counselor is present to facilitate discussions and provide feedback and support. Studies of Facebook-delivered interventions have been conducted on a variety of topics, and they vary widely in terms of the intervention content used in the group, use of human counselors, group size, engagement, and other characteristics. In addition, results vary widely and may depend on how well the intervention was executed and the degree to which it elicited engagement among participants. Best practices for designing and delivering behavioral intervention content for asynchronous delivery in Facebook groups are lacking, as are best practices for engaging participants via this modality. In this tutorial, we propose best practices for the use of private Facebook groups for delivery and testing the efficacy of behavioral or health communication interventions, including converting traditional intervention content into Facebook posts; creating protocols for onboarding, counseling, engagement, and data management; designing and branding intervention content; and using engagement data to optimize engagement and outcomes. %M 39231426 %R 10.2196/58627 %U https://formative.jmir.org/2024/1/e58627 %U https://doi.org/10.2196/58627 %U http://www.ncbi.nlm.nih.gov/pubmed/39231426 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e49714 %T The SoCAP (Social Communication, Affiliation, and Presence) Taxonomy of Social Features: Scoping Review of Commercially Available eHealth Apps %A Kwok,Ian %A Freedman,Melanie %A Kamsickas,Lisa %A Lattie,Emily G %A Yang,Dershung %A Moskowitz,Judith Tedlie %+ Feinberg School of Medicine, Northwestern University, 420 E Superior St, Chicago, IL, 60611, United States, 1 323 364 1160, iankwok@u.northwestern.edu %K eHealth %K digital interventions %K social features %K taxonomy %K computer-human interaction %K social connection %K engagement %K eHealth apps %K intervention %K mental health %K behavioral health %K mobile app %D 2024 %7 3.9.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: eHealth interventions have proven to be valuable resources for users with diverse mental and behavioral health concerns. As these technologies continue to proliferate, both academic researchers and commercial app creators are leveraging the use of features that foster a sense of social connection on these digital platforms. Yet, the literature often insufficiently represents the functionality of these key social features, resulting in a lack of understanding of how they are being implemented. Objective: This study aimed to conduct a methodical review of commercially available eHealth apps to establish the SoCAP (social communication, affiliation, and presence) taxonomy of social features in eHealth apps. Our goal was to examine what types of social features are being used in eHealth apps and how they are implemented. Methods: A scoping review of commercially available eHealth apps was conducted to develop a taxonomy of social features. First, a shortlist of the 20 highest-rated eHealth apps was derived from One Mind PsyberGuide, a nonprofit organization with trained researchers who rate apps based on their (1) credibility, (2) user experience, and (3) transparency. Next, both mobile- and web-based versions of each app were double-coded by 2 trained raters to derive a list of social features. Subsequently, the social features were organized by category and tested on other apps to ensure their completeness. Results: Four main categories of social features emerged: (1) communication features (videoconferencing, discussion boards, etc), (2) social presence features (chatbots, reminders, etc), (3) affiliation and identity features (avatars, profiles, etc), and (4) other social integrations (social network and other app integrations). Our review shows that eHealth apps frequently use resource-intensive interactions (eg, videoconferencing with a clinician and phone calls from a facilitator), which may be helpful for participants with high support needs. Furthermore, among commercially available eHealth apps, there is a strong reliance on automated features (eg, avatars, personalized multimedia, and tailored content) that enhance a sense of social presence without requiring a high level of input from a clinician or staff member. Conclusions: The SoCAP taxonomy includes a comprehensive list of social features and brief descriptions of how these features work. This classification system will provide academic and commercial eHealth app creators with an understanding of the various social features that are commonly implemented, which will allow them to apply these features to enhance their own apps. Future research may include comparing the synergistic effects of various combinations of these social features. %M 39226544 %R 10.2196/49714 %U https://www.jmir.org/2024/1/e49714 %U https://doi.org/10.2196/49714 %U http://www.ncbi.nlm.nih.gov/pubmed/39226544 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e57236 %T Adapting and Evaluating a Brief Advice Tobacco Cessation Intervention in High-reach, Low-resource Settings in India: Protocol for a Cluster Randomized Controlled Trial %A Mahtani,Sitara L %A Viswanath,Kasisomayajula %A Gupte,Himanshu A %A Mandal,Gauri %A Jagiasi,Dinesh %A Chawla,Ratandeep %A D'Costa,Marina %A Xuan,Ziming %A Minsky,Sara %A Ramanadhan,Shoba %+ Dana-Farber Cancer Institute, 450 Brookline Avenue, LW, 6th Floor, Boston, MA, 02215, United States, 1 617 582 9487, sitara_mahtani@dfci.harvard.edu %K tobacco use Cessation %K India %K resource-limited settings %K task-shifting %K counseling %K nonprofit organizations %K dental health services %K tuberculosis %K social media %K mobile app %D 2024 %7 3.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: About 1.35 million deaths annually are attributed to tobacco use in India. The main challenge, given the magnitude of tobacco use and limited resources, is delivering cessation support at scale, low cost, and through a coordinated cross-system effort; one such example being brief advice interventions. However, highly credentialed staff to identify and counsel tobacco users are scarce. Task-shifting is an important opportunity for scaling these interventions. Objective: The LifeFirst SWASTH (Supporting Wellbeing among Adults by Stopping Tobacco Habit) program—adapted from the LifeFirst program (developed by the Narotam Sekhsaria Foundation, Mumbai, India)—is a tobacco cessation program focusing on lower-socioeconomic status patients in Mumbai receiving private health care. This parallel-arm, cluster randomized controlled trial investigates whether the LifeFirst SWASTH program increases tobacco cessation rates in low-resource, high-reach health care settings in Mumbai. Methods: This study will target tuberculosis-specific nongovernmental organizations (NGOs), dental clinics, and NGOs implementing general health programs serving lower-socioeconomic status patients. Intervention arm patients will receive a pamphlet explaining tobacco’s harmful effects. Practitioners will be trained to deliver brief cessation advice, and interested patients will be referred to a Narotam Sekhsaria Foundation counselor for free telephone counseling for 6 months. Control arm patients will receive the same pamphlet but not brief advice or counseling. Practitioners will have a customized mobile app to facilitate intervention delivery. Practitioners will also have access to a peer network through WhatsApp. The primary outcome is a 30-day point prevalence abstinence from tobacco. Secondary outcomes for patients and practitioners relate to intervention implementation. Results: The study was funded in June 2020. Due to the COVID-19 pandemic, the study experienced some delays, and practitioner recruitment commenced in November 2023. As of July 2024, all practitioners have been recruited, and practitioner recruitment and training are complete. Furthermore, 36% (1687/4688) of patients have been recruited. Conclusions: It is hypothesized that those patients who participated in the LifeFirst SWASTH program will be more likely to have been abstinent from tobacco for 30 consecutive days by the end of 6 months or at least decreased their tobacco use. LifeFirst SWASTH, if found to be effective in terms of cessation outcomes and implementation, has the potential to be scaled to other settings in India and other low- and middle-income countries. The study will be conducted in low-resource settings and will reach many patients, which will increase the impact if scaled. It will use task-shifting and an app that can be tailored to different settings, also enabling scalability. Findings will build the literature for translating evidence-based interventions from high-income countries to low- and middle-income countries and from high- to low-resource settings. Trial Registration: ClinicalTrials.gov NCT05234983; https://clinicaltrials.gov/study/NCT05234983 International Registered Report Identifier (IRRID): DERR1-10.2196/57236 %M 39225384 %R 10.2196/57236 %U https://www.researchprotocols.org/2024/1/e57236 %U https://doi.org/10.2196/57236 %U http://www.ncbi.nlm.nih.gov/pubmed/39225384 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e56326 %T Smartphone-Delivered Attentional Bias Modification Training for Mental Health: Systematic Review and Meta-Analysis %A Banire,Bilikis %A Orr,Matt %A Burns,Hailey %A McGowan,Youna %A Orji,Rita %A Meier,Sandra %+ Department of Psychiatry, Faculty of Medicine, Dalhousie University, Sir Charles Tupper Building, 13th Fl., 5850 College Street, Halifax, NS, B34 3H7, Canada, 1 17828825242, banire.bilikis.o@gmail.com %K attentional bias %K mental health problem %K anxiety %K depression %K systematic review %K meta-analysis %K smartphone %K mobile phone %D 2024 %7 2.9.2024 %9 Review %J JMIR Ment Health %G English %X Background: Smartphone-delivered attentional bias modification training (ABMT) intervention has gained popularity as a remote solution for alleviating symptoms of mental health problems. However, the existing literature presents mixed results indicating both significant and insignificant effects of smartphone-delivered interventions. Objective: This systematic review and meta-analysis aims to assess the impact of smartphone-delivered ABMT on attentional bias and symptoms of mental health problems. Specifically, we examined different design approaches and methods of administration, focusing on common mental health issues, such as anxiety and depression, and design elements, including gamification and stimulus types. Methods: Our search spanned from 2014 to 2023 and encompassed 4 major databases: MEDLINE, PsycINFO, PubMed, and Scopus. Study selection, data extraction, and critical appraisal were performed independently by 3 authors using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. When necessary, we pooled the standardized mean difference with a 95% CI. In addition, we conducted sensitivity, subgroup, and meta-regression analyses to explore moderator variables of active and placebo ABMT interventions on reducing symptoms of mental health problems and attentional bias. Results: Our review included 12 papers, involving a total of 24,503 participants, and we were able to conduct a meta-analysis on 20 different study samples from 11 papers. Active ABMT exhibited an effect size (Hedges g) of –0.18 (P=.03) in reducing symptoms of mental health problems, while the overall effect remained significant. Similarly, placebo ABMT showed an effect size of –0.38 (P=.008) in reducing symptoms of mental health problems. In addition, active ABMT (Hedges g –0.17; P=.004) had significant effects on reducing attentional bias, while placebo ABMT did not significantly alter attentional bias (Hedges g –0.04; P=.66). Conclusions: Our understanding of smartphone-delivered ABMT’s potential highlights the value of both active and placebo interventions in mental health care. The insights from the moderator analysis also showed that tailoring smartphone-delivered ABMT interventions to specific threat stimuli and considering exposure duration are crucial for optimizing their efficacy. This research underscores the need for personalized approaches in ABMT to effectively reduce attentional bias and symptoms of mental health problems. Trial Registration: PROSPERO CRD42023460749; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=460749 %M 39222349 %R 10.2196/56326 %U https://mental.jmir.org/2024/1/e56326 %U https://doi.org/10.2196/56326 %U http://www.ncbi.nlm.nih.gov/pubmed/39222349 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e59088 %T Prescription Digital Therapeutics for Substance Use Disorder in Primary Care: Mixed Methods Evaluation of a Pilot Implementation Study %A Mogk,Jessica %A Idu,Abisola E %A Bobb,Jennifer F %A Key,Dustin %A Wong,Edwin S %A Palazzo,Lorella %A Stefanik-Guizlo,Kelsey %A King,Deborah %A Beatty,Tara %A Dorsey,Caitlin N %A Caldeiro,Ryan M %A Garza McWethy,Angela %A Glass,Joseph E %+ Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Ste 1360, Seattle, WA, 98101, United States, 1 206 287 2900, jessica.m.mogk@kp.org %K implementation %K digital therapeutics %K substance use disorder %K practice facilitation %K health coaching %K primary care %K mobile phone %D 2024 %7 2.9.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Delivering prescription digital therapeutics (ie, evidence-based interventions designed to treat, manage, or prevent disorders via websites or smartphone apps) in primary care could increase patient access to substance use disorder (SUD) treatments. However, the optimal approach to implementing prescription digital therapeutics in primary care remains unknown. Objective: This pilot study is a precursor to a larger trial designed to test whether implementation strategies (practice facilitation [PF] and health coaching [HC]) improve the delivery of prescription digital therapeutics for SUDs in primary care. This mixed methods study describes outcomes among patients in the 2 pilot clinics and presents qualitative findings on implementation. Methods: From February 10 to August 6, 2021, a total of 3 mental health specialists embedded in 2 primary care practices of the same integrated health system were tasked with offering app-based prescription digital therapeutics to patients with SUD. In the first half of the pilot, implementation activities included training and supportive tools. PF (at 1 clinic) and HC (at 2 clinics) were added in the second half. All study analyses relied on secondary data, including electronic health records and digital therapeutic vendor data. Primary outcomes were the proportion of patients reached by the prescription digital therapeutics and fidelity related to ideal use. We used qualitative methods to assess the adherence to planned activities and the barriers and facilitators to implementing prescription digital therapeutics. Results: Of all 18 patients prescribed the apps, 10 (56%) downloaded the app and activated their prescription, and 8 (44%) completed at least 1 module of content. Patients who activated the app completed 1 module per week on average. Ideal use (fidelity) was defined as completing 4 modules per week and having a monthly SUD-related visit; 1 (6%) patient met these criteria for 10 weeks (of the 12-week prescription period). A total of 5 (28%) patients had prescriptions while HC was available, 2 (11%) were successfully contacted, and both declined coaching. Clinicians reported competing clinical priorities, technical challenges, and logistically complex workflows in part because the apps required a prescription. Some pilot activities were impacted by staff turnover that coincided with the COVID-19 pandemic. The facilitators to implementation were high engagement and the perception that the apps could meet patient needs. Conclusions: The pilot study encountered the barriers to implementing prescription digital therapeutics in a real-world primary care setting, especially staffing shortages, turnover, and competing priorities for clinic teams. The larger randomized trial will clarify the extent to which PF and HC improve the implementation of digital therapeutics. Trial Registration: ClinicalTrials.gov NCT04907045; https://clinicaltrials.gov/study/NCT04907045 %M 39222348 %R 10.2196/59088 %U https://formative.jmir.org/2024/1/e59088 %U https://doi.org/10.2196/59088 %U http://www.ncbi.nlm.nih.gov/pubmed/39222348 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56957 %T Feasibility and Acceptability Study of a Culturally Adapted Web-Based Intervention to Reduce Suicidal Ideation for Syrian Asylum Seekers and Refugees in the United Kingdom: Protocol for a Mixed Methods Study %A Beuthin,Oliver %A Shahid,Sadiya %A Yu,Ly-Mee %A Bhui,Kamaldeep %+ Department of Psychiatry, University of Oxford, Linacre College, St Cross Road, Oxford, OX1 3JA, United Kingdom, 44 1865 618200, oliver.beuthin@linacre.ox.ac.uk %K cultural adaptation %K digital mental health %K suicidal ideation %K refugee mental health %K Syrian refugee %K experience-based co-design %K mental health %K suicide %K suicidal %K refugee %K immigrant %K ethnic minority %K asylum %K user experience %K cultural %K Syria %K Syrian %K refugees %K feasibility %K acceptability %K depression %K anxiety %K posttraumatic stress disorder %K United Kingdom %K Arabic-speaking %D 2024 %7 2.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The war in Syria has displaced over 6.8 million people, more than any other conflict since the Second World War. As a result, Syrian asylum seekers and refugees have experienced several life-changing events, resulting in high rates of anxiety, depression, posttraumatic stress disorder, and suicidal ideation (SI). To address the treatment gap and reduce the burden of help-seeking, a web-based intervention to reduce SI developed for general populations was culturally adapted for and with Syrian asylum seekers and refugees in the United Kingdom. The study revealed the importance of understanding their lived experience with migration and the acculturative process in providing treatment for SI. This study will now assess the feasibility and acceptability of the culturally adapted intervention for this population. Objective: The first phase of the study will include recruiting participants and delivering the web-based intervention (1) to assess the feasibility of meeting recruitment goals and recruitment rates and (2) to assess the feasibility of outcome measures. The second phase of the study will include one-to-one semistructured interviews (1) to assess the suitability of the culturally adapted intervention in terms of recruitment and adherence rates and barriers and facilitators to engagement and (2) to assess the acceptability of the intervention in terms of its cultural relevance and appropriateness. Methods: This is a protocol for a single-group, noncontrolled, mixed methods feasibility and acceptability study of a culturally adapted web-based intervention to reduce SI for Syrian asylum seekers and refugees in the United Kingdom. The study will assess the feasibility of recruitment goals, recruitment rates, adherence rates, and outcome measures using individual participant tracking forms, which will be analyzed quantitatively. The suitability and acceptability of the intervention will be assessed using one-to-one semistructured interviews with 12 participants who completed the intervention, which will be analyzed qualitatively. Results: Recruitment began in February 2024 and will run until 30 participants are recruited to the study or until the end of July 2024. Thus far, 19 participants have provided informed consent, 16 were eligible and enrolled, and 12 have completed a postintervention interview. No data have been analyzed. The study, including the write-up period, is expected to end in December 2024. Conclusions: Despite experiencing several stressors related to forced displacement and high rates of mental health issues, access to treatment is still limited for Syrian asylum seekers and refugees in the United Kingdom. To address the treatment gap and reduce the burden of help-seeking, a web-based intervention to reduce SI was culturally adapted in collaboration with Syrian asylum seekers and refugees in the United Kingdom. This study will now assess the feasibility and acceptability of the intervention and culturally appropriate recruitment strategies. Trial Registration: ISRCTN ISRCTN11417025; https://www.isrctn.com/ISRCTN11417025 International Registered Report Identifier (IRRID): PRR1-10.2196/56957 %M 39222345 %R 10.2196/56957 %U https://www.researchprotocols.org/2024/1/e56957 %U https://doi.org/10.2196/56957 %U http://www.ncbi.nlm.nih.gov/pubmed/39222345 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e54252 %T Examining a Fully Automated Mobile-Based Behavioral Activation Intervention in Depression: Randomized Controlled Trial %A Santopetro,Nicholas %A Jones,Danielle %A Garron,Andrew %A Meyer,Alexandria %A Joyner,Keanan %A Hajcak,Greg %K digital intervention %K digital health %K digital application %K digital applications %K mobile health %K mHealth %K automation %K automate %K automated %K behavioral activation %K BA %K BA intervention %K depression %K depressed %K depressive %K depressive symptoms %K anhedonia %K anhedonia symptoms %K anxiety %K anxious %K anxiety symptoms %K adults %K adult %K psychiatry %K psych %K psychology %K major depressive disorder %K MDD %D 2024 %7 30.8.2024 %9 %J JMIR Ment Health %G English %X Background: Despite significant progress in our understanding of depression, prevalence rates have substantially increased in recent years. Thus, there is an imperative need for more cost-effective and scalable mental health treatment options, including digital interventions that minimize therapist burden. Objective: This study focuses on a fully automated digital implementation of behavioral activation (BA)—a core behavioral component of cognitive behavioral therapy for depression. We examine the efficacy of a 1-month fully automated SMS text message–based BA intervention for reducing depressive symptoms and anhedonia. Methods: To this end, adults reporting at least moderate current depressive symptoms (8-item Patient Health Questionnaire score ≥10) were recruited online across the United States and randomized to one of three conditions: enjoyable activities (ie, BA), healthy activities (ie, an active control condition), and passive control (ie, no contact). Participants randomized to enjoyable and healthy activities received daily SMS text messages prompting them to complete 2 activities per day; participants also provided a daily report on the number and enjoyment of activities completed the prior day. Results: A total of 126 adults (mean age 32.46, SD 7.41 years) with current moderate depressive symptoms (mean score 16.53, SD 3.90) were recruited. Participants in the enjoyable activities condition (BA; n=39) experienced significantly greater reductions in depressive symptoms compared to participants in the passive condition (n=46). Participants in both active conditions—enjoyable activities and healthy activities (n=41)—reported reduced symptoms of anxiety compared to those in the control condition. Conclusions: These findings provide preliminary evidence regarding the efficacy of a fully automated digital BA intervention for depression and anxiety symptoms. Moreover, reminders to complete healthy activities may be a promising intervention for reducing anxiety symptoms. Trial Registration: ClincalTrials.gov NCT06492824; https://clinicaltrials.gov/study/NCT06492824 %R 10.2196/54252 %U https://mental.jmir.org/2024/1/e54252 %U https://doi.org/10.2196/54252 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e50071 %T Effectiveness of a Smartphone-Based Stress Management Program for Depression in Hospital Nurses During COVID-19 in Vietnam and Thailand: 2-Arm Parallel-Group Randomized Controlled Trial %A Watanabe,Kazuhiro %A Tran,Thuy Thi Thu %A Sripo,Narisara %A Sakuraya,Asuka %A Imamura,Kotaro %A Boonyamalik,Plernpit %A Sasaki,Natsu %A Tienthong,Thanate %A Asaoka,Hiroki %A Iida,Mako %A Nguyen,Quynh Thuy %A Nguyen,Nga Thi %A Vu,Son Thai %A Ngo,Thuy Thi %A Luyen,Tham Thi %A Nguyen,Long Duc %A Nguyen,Nga Thi Viet %A Nguyen,Binh Thanh %A Matsuyama,Yutaka %A Takemura,Yukie %A Nishi,Daisuke %A Tsutsumi,Akizumi %A Nguyen,Huong Thanh %A Kaewboonchoo,Orawan %A Kawakami,Norito %+ Department of Digital Mental Health, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan, 81 3 5800 9621, nkawakami@m.u-tokyo.ac.jp %K digital mental health intervention %K unguided program %K universal prevention %K health care workers %K nurses %K COVID-19 %K depression %K mobile phone %D 2024 %7 30.8.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: During the COVID-19 pandemic, health care professionals experienced high levels of depression. However, extant research has not highlighted effective internet-based psychological interventions to improve the mental health in this population during the pandemic. It remains unclear whether self-guided, internet-based cognitive behavioral therapy (iCBT) programs are effective in improving the mental health of health care workers during the COVID-19 pandemic. Objective: The aim of this study was to evaluate the effectiveness of a smartphone-based iCBT stress management program for reducing the depression experienced by nurses in Vietnam and Thailand. Methods: From March to April 2022, a 2-arm, parallel-group randomized controlled trial was implemented. One arm offered a 7-week self-guided iCBT program, and the other offered treatment as usual as a control arm. Full-time nurses were recruited from 6 hospitals: 2 hospitals in Vietnam and 4 hospitals in Thailand. The primary outcome of this program was the severity of depression measured by the Depression Anxiety Stress Scale-21 items. Follow-up surveys were conducted to measure the change in depression severity at 3 months (July-August 2022) and at 6 months (October-November 2022) after baseline. Mixed modeling for repeated measures was used to test the effects of the intervention compared with the control for the follow-up. Results: A total of 1203 nurses were included in this study: 602 in the intervention group and 601 in the control group. The follow-up rate at 3 and 6 months ranged from 85.7% (515/601) to 87.5% (527/602). The completion rate for the program was 68.1% (410/602). The group difference in depression was significant at the 3-month follow-up (coefficient=–0.92, 95% CI –1.66 to –0.18; P=.02) and nonsignificant at the 6-month follow-up (coefficient=–0.33, 95% CI –1.11 to 0.45; P=.41). The estimated effect sizes were –0.15 and –0.06 at the 3- and 6-month follow-ups, respectively. Conclusions: Our study shows that the smartphone-based iCBT program was effective in reducing depression at the 3-month follow-up among hospital nurses in Vietnam and Thailand during the COVID-19 pandemic. However, the effect size was small, and therefore, these results may not be clinically meaningful. Trial Registration: UMIN Clinical Trials Registry UMIN000044145; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000050128 International Registered Report Identifier (IRRID): RR2-10.20944/preprints202303.0450.v1 %M 39213033 %R 10.2196/50071 %U https://www.jmir.org/2024/1/e50071 %U https://doi.org/10.2196/50071 %U http://www.ncbi.nlm.nih.gov/pubmed/39213033 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e56119 %T Web-Based Coping Skills Training and Coach Support for Women Living With a Partner With an Alcohol Use Disorder: Randomized Controlled Trial %A Rychtarik,Robert G %A Danaher,Brian G %A McGillicuddy,Neil B %A Tyler,Milagra S %A Barrick,Christopher %A Leong,Florence %A Kosty,Derek B %+ Department of Psychiatry and Clinical and Research Institute on Addictions, University at Buffalo, The State University of New York, 1021 Main Street, Buffalo, NY, 14203, United States, 1 7168872591, rgr@buffalo.edu %K alcohol use disorder %K AUD %K spouses %K coping skills training %K eHealth %K coaching %K telehealth %K web-based %K women %K randomized controlled trial %K RCT %K mobile phone %D 2024 %7 29.8.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Individuals living with a partner with an alcohol use disorder (AUD) can experience significant psychological distress and use health care more than those without a partner with an AUD. However, the prevailing treatment system’s focus on the partner and personal barriers limit these individuals from getting help for themselves. Preliminary work on a self-directed, web-based coping skills training program, Stop Spinning My Wheels (SSMW), shows promise in broadening available treatments for this population. In this study, we conducted a robust evaluation of SSMW primary outcomes. Objective: The study aims to test whether women with a partner with an AUD assigned to SSMW experienced a greater reduction in negative affect (depression and anger) (1) than a usual web care (UWC) control and (2) with brief phone coach support (SSMW+coach) rather than without (SSMW only) and (3) whether baseline negative affect moderated treatment effects. Methods: Women (mean age 45.7, SD 10.8 years; Black: 17/456, 3.7%; White: 408/456, 89.5%) were randomized to SSMW only, SSMW+coach, or UWC. Depression (Beck Depression Inventory–II) and anger (State-Trait Anger Expression Inventory 2–State Anger) were assessed at baseline, 12-week posttest, and 6- and 12-month follow-ups. Results: Participants in all conditions decreased in depression from baseline to posttest and from baseline to follow-up; SSMW-only and SSMW+coach participants decreased in anger, but UWC participants did not. Compared to UWC participants, SSMW-only participants experienced greater anger reduction (P=.03), and SSMW+coach participants experienced a greater reduction in depression (P<.001) from baseline to posttest. However, from baseline to follow-up, only a greater, but not statistically significant (P=.052), reduction in anger occurred in SSMW+coach compared to UWC. Although the SSMW conditions did not differ from each other in negative affect outcomes (P=.06-.57), SSMW+coach had higher program engagement and satisfaction (all P<.004). Baseline negative affect did not moderate effects, although remission from baseline clinically relevant depressive symptoms (Beck Depression Inventory≥14) was higher in SSMW only (33/67, 49%; odds ratio 2.13, 95% CI 1.05-4.30; P=.03) and SSMW+coach (46/74, 62%; odds ratio 3.60, 95% CI 1.79-7.23; P<.001) than in UWC (21/67, 31%); remission rates did not differ between the SSMW conditions (P=.12). Conclusions: The results partially supported the hypotheses. The SSMW conditions had earlier effects than UWC, but positive change in UWC mitigated the hypothesized long-term SSMW-UWC differences. The results highlight the importance of incorporating active controls in web-based clinical trials. Although SSMW+coach showed benefits over SSMW only on engagement and satisfaction measures and in the number needed to treat (5.6 for SSMW only; 3.2 for SSMW+coach), the SSMW conditions were comparable and superior to UWC on depressive symptom remission levels. Overall, SSMW with or without a coach can reduce clinically meaningful distress and add to available treatment options for this large, underserved group. Trial Registration: ClinicalTrials.gov NCT02984241; https://www.clinicaltrials.gov/study/NCT02984241 %M 39208412 %R 10.2196/56119 %U https://www.jmir.org/2024/1/e56119 %U https://doi.org/10.2196/56119 %U http://www.ncbi.nlm.nih.gov/pubmed/39208412 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e59013 %T Digital Health Applications (DiGAs) on a Fast Track: Insights From a Data-Driven Analysis of Prescribable Digital Therapeutics in Germany From 2020 to Mid-2024 %A Goeldner,Moritz %A Gehder,Sara %+ Working Group for Data-Driven Innovation, Hamburg University of Technology, Am Schwarzenberg-Campus 4, Hamburg, 21073, Germany, 49 40428784777, moritz.goeldner@tuhh.de %K digital health application %K DiGA %K data-driven analysis %K clinical evidence %K health economics %K positive care effect %K medical benefit %K patient-relevant structural and procedural improvements %K pSVV %K digital health care act %D 2024 %7 29.8.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: This study aimed to analyze the rapidly evolving ecosystem of digital health applications (Digitale Gesundheitsanwendung; DiGAs) in Germany, spurred by the 2019 Digital Healthcare Act. With over 73 million people in Germany now having access to DiGAs, these prescribable digital health apps and web-based applications represent a substantial stride in health care modernization, supporting both patients and health care providers with digital solutions for disease management and care improvement. Objective: Through a data-driven approach, this research aimed to unpack the complexities of DiGA market dynamics, economic factors, and clinical evidence, offering insights into their impact over the past years. Methods: The analysis draws from a range of public data sources, including the DiGA directory, statutory health insurance reports, app store feedback, and clinical study results. Results: As of July 1, 2024, there are 56 DiGAs listed by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte), divided into 35 permanently and 21 preliminarily listed applications. Our findings reveal that a majority of DiGAs extend beyond the intended 1-year period to achieve permanent listing, reflecting the extensive effort required to demonstrate clinical efficacy. Economic analysis uncovered a dynamic pricing landscape, with initial prices ranging from approximately €200 to €700 (€1=US $1.07), averaging at a median of €514 for a 3-month DiGA prescription. Following negotiations or arbitration board decisions, prices typically see a 50% reduction, settling at a median of €221. Prescription data offer valuable insights into DiGA acceptance, with total prescriptions jumping from around 41,000 in the first period to 209,000 in the latest reporting period. The analysis of the top 15 DiGAs, representing 82% of the total prescriptions, shows that these best-performing apps receive from a minimum of 8 to a maximum of 77 daily prescriptions, with native apps and early market entrants achieving higher rates. Clinical evidence from all 35 permanently listed DiGAs indicates a uniform preference for randomized controlled trials to validate primary end points, with no noteworthy use of alternative study designs encouraged in the Digital Healthcare Act and related regulations. Moreover, all evaluated DiGAs focused on medical benefits, with health status improvement as a key end point, suggesting an underuse of patient-relevant structural and procedural improvement in demonstrating health care impact. Conclusions: This study highlights the growth and challenges within the DiGA sector, suggesting areas for future research, such as the exploration of new study designs and the potential impact of patient-relevant structural and procedural improvements. For DiGA manufacturers, the strategic advantage of early market entry is emphasized. Overall, this paper underscores the evolving landscape of digital health, advocating for a nuanced understanding of digital health technology integration in Germany and beyond. %M 39208415 %R 10.2196/59013 %U https://www.jmir.org/2024/1/e59013 %U https://doi.org/10.2196/59013 %U http://www.ncbi.nlm.nih.gov/pubmed/39208415 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e58253 %T Sociodemographic, Health, and Lifestyle-Related Characteristics Associated With the Commencement and Completion of a Web-Based Lifestyle Educational Program for People With Multiple Sclerosis: Randomized Controlled Trial %A Reece,Jeanette %A Yu,Maggie %A Bevens,William %A Simpson-Yap,Steve %A Davenport,Rebekah %A Jelinek,George %A Neate,Sandra %+ Institute for Clinical and Translational Science, University of California, 843 Health Science Rd, 1301 Hewitt Hall, Irvine, CA, 9269, United States, 1 5103382170, wbevens@health.ucsd.edu %K multiple sclerosis %K web-based education %K lifestyle %K randomized controlled trial %K engagement %K completion %D 2024 %7 28.8.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital health interventions increase access to multiple sclerosis (MS)–related knowledge for people living with MS; however, our understanding of factors associated with engagement in web-based learning is limited. Objective: This study aims to examine associations between participant sociodemographic, health, and lifestyle-related characteristics and the commencement and completion of the Multiple Sclerosis Online Course (MSOC) in a randomized controlled trial (RCT). Methods: An intervention course was developed based on the Overcoming MS Program—an evidence-based lifestyle modification program for MS, and a standard care course was developed based on international MS website information. An RCT was conducted to compare the effectiveness of the intervention course versus the standard care course in improving health outcomes in people living with MS. Participant data were collected from a baseline survey. Associations between baseline participant characteristics and MSOC commencement and completion, respectively, were assessed using multivariate log-binomial regression. Results: Overall, 1893 participants enrolled in the RCT, and 45.27% (n=857) completed the baseline survey: 23.5% (n=444) in the intervention course and 21.8% (n=413) in the standard care course. Of these 857 participants, 631 (73.6%) commenced the standard care course or intervention course, and 49.1% (218/444) and 54.2% (224/413) completed the intervention course and standard care course, respectively. University education, partnered relationship status, and higher mental and physical quality of life were associated with 19%, 12%, 20%, and 22% higher rates of course commencement, respectively. Clinically significant fatigue was associated with a 10% reduction in the likelihood of commencement. Strongest associations with intervention course completion included middle and older adulthood, male sex, fatigue, and preexisting adherence to a diet program, with 96%, 27%, 24%, and 19% higher rates of completion observed, respectively, whereas higher self-efficacy was associated with up to 35% lower intervention course completion. Associations with standard care course completion included practicing meditation (20% higher completion), whereas employment was associated with 22% lower completion. Conclusions: Sociodemographic and clinical factors, as well as lifestyle-related factors, were important factors in MSOC commencement and completion. These data may help guide the design and enhancement of digital health interventions tailored for people living with MS. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621001605886; https://tinyurl.com/2vyve9p9 International Registered Report Identifier (IRRID): RR2-10.1186/s12883-023-03298-0 %M 39197163 %R 10.2196/58253 %U https://www.jmir.org/2024/1/e58253 %U https://doi.org/10.2196/58253 %U http://www.ncbi.nlm.nih.gov/pubmed/39197163 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e52919 %T Expectations and Preferences for Digital Cessation Treatment: Multimethods Study Among Older Adults Who Smoke Cigarettes %A Fahey,Margaret C %A Carpenter,Mathew J %A O'Neal,Riley %A Pebley,Kinsey %A Schick,Melissa R %A Ware,Emily %A Toll,Benjamin A %A Dahne,Jennifer %+ Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, 86 Jonathan Lucas Street, Charleston, SC, 29425, United States, 1 6158389307, mfahey@mtsu.edu %K older adults %K digital health %K digital cessation treatment %K smoking cessation %K digital cessation %K treatment %K smoke %K cigarettes %K cigarette %K tobacco %K adults %K elderly %K older person %K older people %K aging %K smoking %K smoke %K quit %K quitting %K questionnaire %K telehealth %K treatment %K treatments %K behavioral health %K public health %K mobile phone %D 2024 %7 28.8.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: To address enduring age-related tobacco disparities, it is critical to promote cessation treatment among older adults (aged 65+ years). Digital health platforms offer opportunities for wide dissemination of evidence-based behavioral cessation support. However, existing digital cessation treatments are not tailored to unique aging-related needs and preferences, resulting in low uptake. Detailed information is needed about how to best adapt these treatments for this age group. Objective: We aimed to collect detailed, hypothesis-generating information about expectations and preferences for cessation digital treatment among older adults who smoke cigarettes. Methods: Semistructured interviews were conducted with adults aged 65+ years currently smoking or who had quit within the past month. Interviews included open-ended questions regarding prior experiences with digital health platforms and expectations and preferences for cessation treatment via various modalities (app-delivered, texting-based, or videoconferencing counseling). Interviews also elicited questions regarding digital modalities that integrated social components (app-delivered social forums and group videoconferencing counseling). Using an iterative, team-based approach, the thematic analysis identified meaningful themes. Interviews were supplemented with quantitative measures assessing sociodemographics, digital literacy, and physical health symptoms. Results: Participants (12/20, 60% men; 15/20, 75% White; 4/20, 20% Black or African American; 1/20, 5% Asian) were currently smoking (17/20, 85%) or had recently quit (3/20, 15%). Thematic analysis identified 3 meaningful themes across all digital modalities: convenience, accessibility, and personalization. Expected benefits of digital platforms included convenient treatment access, without reliance on transportation. Participants preferred treatments to be personalized and deliver content or strategies beyond standard education. Most (17/20, 85%) were unfamiliar with cessation apps but found them appealing given the potential for offering a novel quitting strategy. App ease of use (eg, easy navigation) was preferred. Half (10/20, 50%) would try a texting-based intervention, with many preferring texting with a counselor rather than automated messaging. Most (17/20, 85%) would use videoconferencing and expected this modality to deliver better quality counseling than via telephone. Expected videoconferencing challenges included looking presentable onscreen, technological difficulties, and privacy or security. Videoconferencing was regarded as the most personalized digital treatment, yet benefits unique to app-delivered and texting-based treatments included anonymity and access to treatment 24/7. Participants expected integrating social components into digital treatment to be useful for quit success and social connection, yet were concerned about possible interpersonal challenges. Conclusions: Because a long history of quit attempts and familiarity with standard quitting advice is common among older adults who smoke cigarettes, digital platforms might offer appealing and novel strategies for cessation that are accessible and convenient. Overall, this population was open to trying digital cessation treatments and would prefer that these platforms prioritize ease of use and personalized content. These findings challenge the bias that older adults are uninterested or unwilling to engage with digital treatments for behavioral health. %M 39196628 %R 10.2196/52919 %U https://www.jmir.org/2024/1/e52919 %U https://doi.org/10.2196/52919 %U http://www.ncbi.nlm.nih.gov/pubmed/39196628 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e58735 %T Framework Development for Reducing Attrition in Digital Dietary Interventions: Systematic Review and Thematic Synthesis %A Wang,Jian %A Mahe,Jinli %A Huo,Yujia %A Huang,Weiyuan %A Liu,Xinru %A Zhao,Yang %A Huang,Junjie %A Shi,Feng %A Li,Zhihui %A Jiang,Dou %A Li,Yilong %A Perceval,Garon %A Zhao,Lindu %A Zhang,Lin %+ Suzhou Industrial Park Monash Research Institute of Science and Technology, Monash University, Room 805, 8th Floor, Building 2, Sangtian Island Science and Technology Innovation Park, No. 1, Huayun Road, Suzhou, China, 86 13426423807, lin.zhang2@monash.edu %K thematic synthesis %K attrition rate %K dropout %K behavior change theory %K digital dietary intervention %K digital health %K mHealth %K eHealth %K mobile apps %K email %D 2024 %7 27.8.2024 %9 Review %J J Med Internet Res %G English %X Background: Dietary behaviors significantly influence health outcomes across populations. Unhealthy diets are linked to serious diseases and substantial economic burdens, contributing to approximately 11 million deaths and significant disability-adjusted life years annually. Digital dietary interventions offer accessible solutions to improve dietary behaviors. However, attrition, defined as participant dropout before intervention completion, is a major challenge, with rates as high as 75%-99%. High attrition compromises intervention validity and reliability and exacerbates health disparities, highlighting the need to understand and address its causes. Objective: This study systematically reviews the literature on attrition in digital dietary interventions to identify the underlying causes, propose potential solutions, and integrate these findings with behavior theory concepts to develop a comprehensive theoretical framework. This framework aims to elucidate the behavioral mechanisms behind attrition and guide the design and implementation of more effective digital dietary interventions, ultimately reducing attrition rates and mitigating health inequalities. Methods: We conducted a systematic review, meta-analysis, and thematic synthesis. A comprehensive search across 7 electronic databases (PubMed, MEDLINE, Embase, CENTRAL, Web of Science, CINAHL Plus, and Academic Search Complete) was performed for studies published between 2013 and 2023. Eligibility criteria included original research exploring attrition in digital dietary interventions. Data extraction focused on study characteristics, sample demographics, attrition rates, reasons for attrition, and potential solutions. We followed ENTREQ (Enhancing the Transparency in Reporting the Synthesis of Qualitative Research) and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and used RStudio (Posit) for meta-analysis and NVivo for thematic synthesis. Results: Out of the 442 identified studies, 21 met the inclusion criteria. The meta-analysis showed mean attrition rates of 35% for control groups, 38% for intervention groups, and 40% for observational studies, with high heterogeneity (I²=94%-99%) indicating diverse influencing factors. Thematic synthesis identified 15 interconnected themes that align with behavior theory concepts. Based on these themes, the force-resource model was developed to explore the underlying causes of attrition and guide the design and implementation of future interventions from a behavior theory perspective. Conclusions: High attrition rates are a significant issue in digital dietary interventions. The developed framework conceptualizes attrition through the interaction between the driving force system and the supporting resource system, providing a nuanced understanding of participant attrition, summarized as insufficient motivation and inadequate or poorly matched resources. It underscores the critical necessity for digital dietary interventions to balance motivational components with available resources dynamically. Key recommendations include user-friendly design, behavior-factor activation, literacy training, force-resource matching, social support, personalized adaptation, and dynamic follow-up. Expanding these strategies to a population level can enhance digital health equity. Further empirical validation of the framework is necessary, alongside the development of behavior theory–guided guidelines for digital dietary interventions. Trial Registration: PROSPERO CRD42024512902; https://tinyurl.com/3rjt2df9 %M 39190910 %R 10.2196/58735 %U https://www.jmir.org/2024/1/e58735 %U https://doi.org/10.2196/58735 %U http://www.ncbi.nlm.nih.gov/pubmed/39190910 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e58121 %T Beta Test of a Christian Faith-Based Facebook Intervention for Smoking Cessation in Rural Communities (FaithCore): Development and Usability Study %A Sharma,Pravesh %A Tranby,Brianna %A Kamath,Celia %A Brockman,Tabetha A %A Lenhart,Ned %A Quade,Brian %A Abuan,Nate %A Halom,Martin %A Staples,Jamie %A Young,Colleen %A Brewer,LaPrincess %A Patten,Christi %+ Department of Psychiatry and Psychology, Mayo Clinic Health System, 1221 Whipple St, Eau Claire, WI, 54703, United States, 1 715 838 5369, sharma.pravesh@mayo.edu %K social media %K Facebook %K rural %K smoking %K cessation %K quitline %K community-based participatory research %K CBPR %K FaithCore %K mobile phone %D 2024 %7 26.8.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Individuals living in rural communities experience substantial geographic and infrastructure barriers to attaining health equity in accessing tobacco use cessation treatment. Social media and other digital platforms offer promising avenues to improve access and overcome engagement challenges in tobacco cessation efforts. Research has also shown a positive correlation between faith-based involvement and a lower likelihood of smoking, which can be used to engage rural communities in these interventions. Objective: This study aimed to develop and beta test a social intervention prototype using a Facebook (Meta Platforms, Inc) group specifically designed for rural smokers seeking evidence-based smoking cessation resources. Methods: We designed a culturally aligned and faith-aligned Facebook group intervention, FaithCore, tailored to engage rural people who smoke in smoking cessation resources. Both intervention content and engagement strategies were guided by community-based participatory research principles. Given the intervention’s focus on end users, that is, rural people who smoked, we conducted a beta test to assess any technical or usability issues of this intervention before any future trials for large-scale implementation. Results: No critical beta test technical and usability issues were noted. Besides, the FaithCore intervention was helpful, easy to understand, and achieved its intended goals. Notably, 90% (9/10) of the participants reported that they tried quitting smoking, while 90% (9/10) reported using or seeking cessation resources discussed within the group. Conclusions: This study shows that social media platform with culturally aligned and faith-aligned content and engagement strategies delivered by trained moderators are promising for smoking cessation interventions in rural communities. Our future step is to conduct a large pilot trial to evaluate the intervention’s effectiveness on smoking cessation outcomes. %M 39186365 %R 10.2196/58121 %U https://formative.jmir.org/2024/1/e58121 %U https://doi.org/10.2196/58121 %U http://www.ncbi.nlm.nih.gov/pubmed/39186365 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e59993 %T Reducing Alcohol Misuse and Promoting Treatment Initiation Among Veterans Through a Brief Internet-Based Intervention: Protocol for a Randomized Controlled Trial %A Pedersen,Eric R %A Davis,Jordan P %A Hummer,Justin F %A Bouskill,Kathryn %A Buch,Keegan D %A Shute,Ireland M %A Fitzke,Reagan E %A Tran,Denise D %A Neighbors,Clayton %A Saba,Shaddy %+ Department of Psychiatry and Behavioral Sciences, Keck School of Medicine, University of Southern California, 2250 Alcazar Street, Los Angeles, CA, 90089, United States, 1 3234424046, eric.pedersen@med.usc.edu %K military %K mental health %K substance use %K mobile %K PTSD %K posttraumatic stress disorder %K drinking %K mobile intervention %K digital intervention %K alcohol %K alcohol misuse %K veterans %K young adults %K depression %K alcohol use %K veteran health %K veteran %D 2024 %7 22.8.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Young adult veterans who served after the September 11 attacks on the United States in 2001 (ie, post-9/11) are at heightened risk for experiencing behavioral health distress and disorders including hazardous drinking, posttraumatic stress disorder, and depression. These veterans often face significant barriers to behavioral health treatment, and reaching them through brief mobile phone–based interventions may help reduce drinking and promote treatment engagement. Objective: Following a successful pilot study, this randomized controlled trial (RCT) aims to further test the efficacy of a brief (ie, single session) mobile phone–delivered personalized normative feedback intervention enhanced with content to promote treatment engagement. Methods: We will conduct an RCT with 800 post-9/11 young adult veterans (aged 18 to 40 years) with potentially hazardous drinking and who have not recently received treatment for any behavioral health problems. Participants will be randomly assigned to the personalized intervention or a control condition with resources for seeking care. The personalized normative feedback module in the intervention focuses on the correction of misperceived norms of peer alcohol use and uses empirically informed approaches to increase motivation to address alcohol use and co-occurring behavioral health problems. Past 30-day drinking, alcohol-related consequences, and treatment-seeking behaviors will be assessed at baseline and 3, 6, 9, and 12 months post intervention. Sex, barriers to care, posttraumatic stress disorder, depression, and severity of alcohol use disorder symptoms will be explored as potential moderators of outcomes. Results: We expect recruitment to be completed within 6 months, with data collection taking 12 months for each enrolled participant. Analyses will begin within 3 months of the final data collection point (ie, 12 months follow-up). Conclusions: This RCT will evaluate the efficacy of a novel intervention for non–treatment-seeking veterans who struggle with hazardous drinking and possible co-occurring behavioral health problems. This intervention has the potential to improve veteran health outcomes and overcome significant barriers to treatment. Trial Registration: ClinicalTrials.gov NCT04244461; https://clinicaltrials.gov/study/NCT04244461 International Registered Report Identifier (IRRID): DERR1-10.2196/59993 %M 39173142 %R 10.2196/59993 %U https://www.researchprotocols.org/2024/1/e59993 %U https://doi.org/10.2196/59993 %U http://www.ncbi.nlm.nih.gov/pubmed/39173142 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e54637 %T Refining the Universal, School-Based OurFutures Mental Health Program to Be Trauma Informed, Gender and Sexuality Diversity Affirmative, and Adherent to Proportionate Universalism: Mixed Methods Participatory Design Process %A Grummitt,Lucinda %A Bailey,Sasha %A Kelly,Erin V %A Birrell,Louise %A Gardner,Lauren A %A Halladay,Jillian %A Chapman,Cath %A Andrews,Jack L %A Champion,Katrina E %A Hunter,Emily %A Egan,Lyra %A Conroy,Chloe %A Tiko,Raaya %A Nguyen,An %A Teesson,Maree %A Newton,Nicola C %A Barrett,Emma L %+ The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Level 6, Jane Foss Russell Building, The University of Sydney, Sydney, 2006, Australia, 61 86279014, lucinda.grummitt@sydney.edu.au %K mental health %K prevention %K school %K depression %K anxiety %K proportionate universalism %D 2024 %7 21.8.2024 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Mental disorders are the leading cause of disease burden among youth. Effective prevention of mental disorders during adolescence is a critical public health strategy to reduce both individual and societal harms. Schools are an important setting for prevention; however, existing universal school-based mental health interventions have shown null, and occasionally iatrogenic, effects in preventing symptoms of common disorders, such as depression and anxiety. Objective: This study aims to report the adaptation process of an established, universal, school-based prevention program for depression and anxiety, OurFutures Mental Health. Using a 4-stage process; triangulating quantitative, qualitative, and evidence syntheses; and centering the voices of young people, the revised program is trauma-informed; lesbian, gay, bisexual, transgender, nonbinary, queer, questioning, and otherwise gender and sexuality diverse (LGBTQA+) affirmative; relevant to contemporary youth; and designed to tailor intervention dosage to those who need it most (proportionate universalism). Methods: Program adaptation occurred from April 2022 to July 2023 and involved 4 stages. Stage 1 comprised mixed methods analysis of student evaluation data (n=762; mean age 13.5, SD 0.62 y), collected immediately after delivering the OurFutures Mental Health program in a previous trial. Stage 2 consisted of 3 focus groups with high school students (n=39); regular meetings with a purpose-built, 8-member LGBTQA+ youth advisory committee; and 2 individual semistructured, in-depth interviews with LGBTQA+ young people via Zoom (Zoom Video Communications) or WhatsApp (Meta) text message. Stage 3 involved a clinical psychologist providing an in-depth review of all program materials with the view of enhancing readability, improving utility, and normalizing emotions while retaining key cognitive behavioral therapy elements. Finally, stage 4 involved fortnightly consultations among researchers and clinicians on the intervention adaptation, drawing on the latest evidence from existing literature in school-based prevention interventions, trauma-informed practice, and adolescent mental health. Results: Drawing on feedback from youth, clinical psychologists, and expert youth mental health researchers, sourced from stages 1 to 4, a series of adaptations were made to the storylines, characters, and delivery of therapeutic content contained in the weekly manualized program content, classroom activities, and weekly student and teacher lesson summaries. Conclusions: The updated OurFutures Mental Health program is a trauma-informed, LBGTQA+ affirmative program aligned with the principles of proportionate universalism. The program adaptation responds to recent mixed findings on universal school-based mental health prevention programs, which include null, small beneficial, and small iatrogenic effects. The efficacy of the refined OurFutures Mental Health program is currently being tested through a cluster randomized controlled trial with up to 1400 students in 14 schools across Australia. It is hoped that the refined program will advance the current stalemate in universal school-based prevention of common mental disorders and ultimately improve the mental health and well-being of young people in schools. %M 39167794 %R 10.2196/54637 %U https://pediatrics.jmir.org/2024/1/e54637 %U https://doi.org/10.2196/54637 %U http://www.ncbi.nlm.nih.gov/pubmed/39167794 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56960 %T Evaluating the Efficacy of a Digital Therapeutic (CT-152) as an Adjunct to Antidepressant Treatment in Adults With Major Depressive Disorder: Protocol for the MIRAI Remote Study %A Rothman,Brian %A Slomkowski,Mary %A Speier,Austin %A Rush,A John %A Trivedi,Madhukar H %A Lawson,Erica %A Fahmy,Michael %A Carpenter,Daniel %A Chen,Dalei %A Forbes,Ainslie %+ Otsuka Pharmaceutical Development & Commercialization, Inc, 508 Carnegie Center Dr, Princeton, NJ, 08540, United States, 1 609 524 6788, brian.rothman@otsuka-us.com %K adherence %K digital placebo %K sham control %K cognitive-emotional training %K Emotional Faces Memory Task %K mobile phone %D 2024 %7 20.8.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Major depressive disorder (MDD) is common worldwide and can be highly disabling. People with MDD face many barriers to treatment and may not experience full symptom relief even when treated. Therefore, new treatment modalities are needed for MDD. Digital therapeutics (DTx) may provide people with MDD an additional treatment option. Objective: This study aimed to describe a phase 3 remote, multicenter, randomized, masked, sham-controlled trial evaluating the efficacy of a smartphone app–based DTx (CT-152) in adult participants diagnosed with MDD, used as an adjunct to antidepressant therapy (ADT). Methods: Participants aged 22-64 years with a current primary diagnosis of MDD and an inadequate response to ADT were included. Participants were randomized 1:1 to CT-152 or a sham DTx. CT-152 is a smartphone app–based DTx that delivers a cognitive-emotional and behavioral therapeutic intervention. The core components of CT-152 are the Emotional Faces Memory Task exercises, brief lessons to learn and apply key therapeutic skills, and SMS text messaging to reinforce lessons and encourage engagement with the app. The sham DTx is a digital working memory exercise with emotionally neutral stimuli designed to match CT-152 for time and attention. Participants took part in the trial for up to 13 weeks. The trial included a screening period of up to 3 weeks, a treatment period of 6 weeks, and an extension period of 4 weeks to assess the durability of the effect. Sites and participants had the option of an in-person or remote screening visit; the remaining trial visits were remote. Efficacy was evaluated using the Montgomery-Åsberg Depression Rating Scale, the Generalized Anxiety Disorder-7, Clinical Global Impression–Severity scale, the Patient Health Questionnaire-9, and the World Health Organization Disability Assessment Schedule 2.0. The durability of the effect was evaluated with the Montgomery-Åsberg Depression Rating Scale and Generalized Anxiety Disorder-7 scale. Adverse events were also assessed. Satisfaction, measured by the Participant and Healthcare Professional Satisfaction Scales, and health status, measured by the EQ-5D-5L, were summarized using descriptive statistics. Results: This study was initiated in February 2021 and had a primary completion date in October 2022. Conclusions: This represents the methodological design for the first evaluation of CT-152 as an adjunct to ADT. This study protocol is methodologically robust and incorporates many aspects of conventional pivotal pharmaceutical phase 3 trial design, such as randomization and safety end points. Novel considerations included the use of a sham comparator, masking considerations for visible app content, and outcome measures relevant to DTx. The rigor of this methodology will provide a more comprehensive understanding of the effectiveness of CT-152. Trial Registration: ClinicalTrials.gov NCT04770285; https://clinicaltrials.gov/study/NCT04770285 International Registered Report Identifier (IRRID): RR1-10.2196/56960 %M 39163592 %R 10.2196/56960 %U https://www.researchprotocols.org/2024/1/e56960 %U https://doi.org/10.2196/56960 %U http://www.ncbi.nlm.nih.gov/pubmed/39163592 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e58448 %T Novel Machine Learning HIV Intervention for Sexual and Gender Minority Young People Who Have Sex With Men (uTECH): Protocol for a Randomized Comparison Trial %A Holloway,Ian W %A Wu,Elizabeth S C %A Boka,Callisto %A Young,Nina %A Hong,Chenglin %A Fuentes,Kimberly %A Kärkkäinen,Kimmo %A Beikzadeh,Mehrab %A Avendaño,Alexandra %A Jauregui,Juan C %A Zhang,Aileen %A Sevillano,Lalaine %A Fyfe,Colin %A Brisbin,Cal D %A Beltran,Raiza M %A Cordero,Luisita %A Parsons,Jeffrey T %A Sarrafzadeh,Majid %+ Department of Social Welfare, UCLA Luskin School of Public Affairs, University of California, Los Angeles, 3250 Public Affairs Building, Los Angeles, CA, 90095, United States, 1 310 983 1461, holloway@luskin.ucla.edu %K HIV %K mobile health %K mHealth %K text messaging %K machine learning %K mobile app %K sexual and gender minority %K Young Men’s Health Project %K YMHP %K motivational interviewing %K substance use %K harm reduction %K mobile phone %D 2024 %7 20.8.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Sexual and gender minority (SGM) young people are disproportionately affected by HIV in the United States, and substance use is a major driver of new infections. People who use web-based venues to meet sex partners are more likely to report substance use, sexual risk behaviors, and sexually transmitted infections. To our knowledge, no machine learning (ML) interventions have been developed that use web-based and digital technologies to inform and personalize HIV and substance use prevention efforts for SGM young people. Objective: This study aims to test the acceptability, appropriateness, and feasibility of the uTECH intervention, a SMS text messaging intervention using an ML algorithm to promote HIV prevention and substance use harm reduction among SGM people aged 18 to 29 years who have sex with men. This intervention will be compared to the Young Men’s Health Project (YMHP) alone, an existing Centers for Disease Control and Prevention best evidence intervention for young SGM people, which consists of 4 motivational interviewing–based counseling sessions. The YMHP condition will receive YMHP sessions and will be compared to the uTECH+YMHP condition, which includes YMHP sessions as well as uTECH SMS text messages. Methods: In a study funded by the National Institutes of Health, we will recruit and enroll SGM participants (aged 18-29 years) in the United States (N=330) to participate in a 12-month, 2-arm randomized comparison trial. All participants will receive 4 counseling sessions conducted over Zoom (Zoom Video Communications, Inc) with a master’s-level social worker. Participants in the uTECH+YMHP condition will receive curated SMS text messages informed by an ML algorithm that seek to promote HIV and substance use risk reduction strategies as well as undergoing YMHP counseling. We hypothesize that the uTECH+YMHP intervention will be considered acceptable, appropriate, and feasible to most participants. We also hypothesize that participants in the combined condition will experience enhanced and more durable reductions in substance use and sexual risk behaviors compared to participants receiving YMHP alone. Appropriate statistical methods, models, and procedures will be selected to evaluate primary hypotheses and behavioral health outcomes in both intervention conditions using an α<.05 significance level, including comparison tests, tests of fixed effects, and growth curve modeling. Results: This study was funded in August 2019. As of June 2024, all participants have been enrolled. Data analysis has commenced, and expected results will be published in the fall of 2025. Conclusions: This study aims to develop and test the acceptability, appropriateness, and feasibility of uTECH, a novel approach to reduce HIV risk and substance use among SGM young adults. Trial Registration: ClinicalTrials.gov NCT04710901; https://clinicaltrials.gov/study/NCT04710901 International Registered Report Identifier (IRRID): DERR1-10.2196/58448 %M 39163591 %R 10.2196/58448 %U https://www.researchprotocols.org/2024/1/e58448 %U https://doi.org/10.2196/58448 %U http://www.ncbi.nlm.nih.gov/pubmed/39163591 %0 Journal Article %@ 2291-9694 %I JMIR Publications %V 12 %N %P e50307 %T Characteristics of Existing Online Patient Navigation Interventions: Scoping Review %A Marsh,Meghan %A Shah,Syeda Rafia %A Munce,Sarah E P %A Perrier,Laure %A Lee,Tin-Suet Joan %A Colella,Tracey J F %A Kokorelias,Kristina Marie %+ Section of Geriatrics, Sinai Health and University Health Network, 600 University Avenue, Geriatrics Department, Toronto, ON, M5G1X5, Canada, 1 4165864800 ext 4573, kristina.kokorelias@sinaihealth.ca %K online %K patient navigation %K peer navigation %K patient navigation interventions %K online patient navigation interventions %K scoping review %K patient portals %K social care services %K online medical tools %K eHealth %K telehealth %K personal support %K social care %K patient navigation intervention %D 2024 %7 19.8.2024 %9 Review %J JMIR Med Inform %G English %X Background: Patient navigation interventions (PNIs) can provide personalized support and promote appropriate coordination or continuation of health and social care services. Online PNIs have demonstrated excellent potential for improving patient knowledge, transition readiness, self-efficacy, and use of services. However, the characteristics (ie, intervention type, mode of delivery, duration, frequency, outcomes and outcome measures, underlying theories or mechanisms of change of the intervention, and impact) of existing online PNIs to support the health and social needs of individuals with illness remain unclear. Objective: This scoping review of the existing literature aims to identify the characteristics of existing online PNIs reported in the literature. Methods: A scoping review based on the guidelines outlined in the Joanna Briggs Institute framework was conducted. A search for peer-reviewed literature published between 1989 and 2022 on online PNIs was conducted using MEDLINE, CINAHL, Embase, PsycInfo, and Cochrane Library databases. Two independent reviewers conducted 2 levels of screening. Data abstraction was conducted to outline key study characteristics (eg, study design, population, and intervention characteristics). The data were analyzed using descriptive statistics and qualitative content analysis. Results: A total of 100 studies met the inclusion criteria. Our findings indicate that a variety of study designs are used to describe and evaluate online PNIs, with literature being published between 2003 and 2022 in Western countries. Of these studies, 39 (39%) studies were randomized controlled trials. In addition, we noticed an increase in reported online PNIs since 2019. The majority of studies involved White females with a diagnosis of cancer and a lack of participants aged 70 years or older was observed. Most online PNIs provide support through navigation, self-management and lifestyle changes, counseling, coaching, education, or a combination of support. Variation was noted in terms of mode of delivery, duration, and frequency. Only a small number of studies described theoretical frameworks or change mechanisms to guide intervention. Conclusions: To our knowledge, this is the first review to comprehensively synthesize the existing literature on online PNIs, by focusing on the characteristics of interventions and studies in this area. Inconsistency in reporting the country of publication, population characteristics, duration and frequency of interventions, and a lack of the use of underlying theories and working mechanisms to inform intervention development, provide guidance for the reporting of future online PNIs. %M 39159443 %R 10.2196/50307 %U https://medinform.jmir.org/2024/1/e50307 %U https://doi.org/10.2196/50307 %U http://www.ncbi.nlm.nih.gov/pubmed/39159443 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e54816 %T Using a Digital Mental Health Intervention for Crisis Support and Mental Health Care Among Children and Adolescents With Self-Injurious Thoughts and Behaviors: Retrospective Study %A Lawrence-Sidebottom,Darian %A Huffman,Landry Goodgame %A Beam,Aislinn Brenna %A McAlister,Kelsey %A Guerra,Rachael %A Parikh,Amit %A Roots,Monika %A Huberty,Jennifer %+ Bend Health, Inc, Ste 200, 821 E Washington Ave, Madison, WI, 53703, United States, 1 8005160975, darian.lawrence@bendhealth.com %K suicide %K self-harm %K collaborative care %K behavioral health %K telehealth %K telemedicine %K eHealth %K collaborative %K collaboration %K suicidal %K self-injury %K crisis %K crises %K mental health %K self-injurious %K anxiety %K depression %K pediatric %K pediatrics %K child %K children %K youth %K adolescent %K adolescents %K teen %K teens %K teenager %K teenagers %K mobile phone %D 2024 %7 16.8.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Self-injurious thoughts and behaviors (SITBs) are increasing dramatically among children and adolescents. Crisis support is intended to provide immediate mental health care, risk mitigation, and intervention for those experiencing SITBs and acute mental health distress. Digital mental health interventions (DMHIs) have emerged as accessible and effective alternatives to in-person care; however, most do not provide crisis support or ongoing care for children and adolescents with SITBs. Objective: To inform the development of digital crisis support and mental health care for children and adolescents presenting with SITBs, this study aims to (1) characterize children and adolescents with SITBs who participate in a digital crisis response service, (2) compare anxiety and depressive symptoms of children and adolescents presenting with SITBs versus those without SITBs throughout care, and (3) suggest future steps for the implementation of digital crisis support and mental health care for children and adolescents presenting with SITBs. Methods: This retrospective study was conducted using data from children and adolescents (aged 1-17 y; N=2161) involved in a pediatric collaborative care DMHI. SITB prevalence was assessed during each live session. For children and adolescents who exhibited SITBs during live sessions, a rapid crisis support team provided evidence-based crisis support services. Assessments were completed approximately once a month to measure anxiety and depressive symptom severity. Demographics, mental health symptoms, and change in the mental health symptoms of children and adolescents presenting with SITBs (group with SITBs) were compared to those of children and adolescents with no SITBs (group without SITBs). Results: Compared to the group without SITBs (1977/2161, 91.49%), the group with SITBs (184/2161, 8.51%) was mostly made up of adolescents (107/184, 58.2%) and female children and adolescents (118/184, 64.1%). At baseline, compared to the group without SITBs, the group with SITBs had more severe anxiety and depressive symptoms. From before to after mental health care with the DMHI, the 2 groups did not differ in the rate of children and adolescents with anxiety symptom improvement (group with SITBs: 54/70, 77% vs group without SITBs: 367/440, 83.4%; χ21=1.2; P=.32) as well as depressive symptom improvement (group with SITBs: 58/72, 81% vs group without SITBs: 255/313, 81.5%; χ21=0; P=.99). The 2 groups also did not differ in the amount of change in symptom severity during care with the DMHI for anxiety (t80.20=1.37; P=.28) and depressive (t83.75=–0.08; P=.99) symptoms. Conclusions: This study demonstrates that participation in a collaborative care DMHI is associated with improved mental health outcomes in children and adolescents experiencing SITBs. These results provide preliminary insights for the use of pediatric DMHIs in crisis support and mental health care for children and adolescents presenting with SITBs, thereby addressing the public health issue of acute mental health crisis in children and adolescents. %M 39151166 %R 10.2196/54816 %U https://formative.jmir.org/2024/1/e54816 %U https://doi.org/10.2196/54816 %U http://www.ncbi.nlm.nih.gov/pubmed/39151166 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53509 %T Short-Term Effects of an eHealth Care Experiential Learning Program Among Patients With Type 2 Diabetes: Randomized Controlled Trial %A Cheng,Yu-Shan %A Lin,Cheng-Pei %A Chen,Lu-Yen Anny %A Hwang,Wei-Ren %A Lin,Yi-Chun %A Chen,Yu-Chi %+ Institute of Clinical Nursing, College of Nursing, National Yang Ming Chiao Tung University, No155, Section 2, Li-Nong Street, Beitou District, Taipei, 112, Taiwan, 886 228267093, ycchen2@nycu.edu.tw %K diabetes %K eHealth literacy %K eHealth %K patient engagement %K experiential learning theory %K experimental learning theory %K type 2 diabetes %K randomized controlled trial %D 2024 %7 16.8.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Type 2 diabetes is a chronic disease with a significant medical burden. eHealth care integrates medicine and technology to enhance the outcomes of such patients; however, adequate eHealth literacy (eHL) is necessary for that to happen. Fostering eHL is crucial for patients with diabetes to engage with eHealth care and receive quality care and timely support. Experiential learning theory can enhance patients’ eHL and skills to use eHealth care technology in their daily care. Objective: This study explored the effectiveness of an eHealth care experiential learning program in improving eHL, patient health engagement, and eHealth care use status among patients with type 2 diabetes in 3 months. Methods: In this randomized controlled trial, patients under case management services from various clinics in Taiwan were randomly assigned to either the intervention group receiving the 6-session eHealth care experiential learning program or the control group receiving the usual care. Data were collected using structured questionnaires at 3 time points: pretest, postintervention, and 3 months after the intervention. Descriptive data were presented using frequency distribution, percentage, mean, and SD. The outcomes were analyzed using a generalized estimating equation method by intention-to-treat analysis. Results: A total of 92 participants (46 in each group) were recruited in this study. Of these, 86 completed the course and follow-up evaluations with a mean age of 62.38 (SD 12.91) years. After completing the intervention, the intervention group had significantly higher posttest scores in eHL (β=19.94, SE 3.52; P<.001), patient health engagement (β=.28, SE 0.13; P=.04), and eHealth use (β=3.96, SE 0.42; P<.001) than the control group. Furthermore, the intervention group maintained these significant improvements in eHL (β=18.19, SE 3.82; P<.001) and eHealth use (β=3.87, SE 0.49; P<.001) after 3 months. Conclusions: Participating in the eHealth care experiential learning program resulted in significant improvements in eHL, patient health engagement, and eHealth use among patients with type 2 diabetes. Our interventional program can inform future clinical practice and policies to strengthen self-management skills and facilitate the use of health technology in caring for patients with chronic diseases. Trial Registration: ClinicalTrials.gov NCT05180604; https://clinicaltrials.gov/ct2/show/NCT05180604 %M 39150761 %R 10.2196/53509 %U https://www.jmir.org/2024/1/e53509 %U https://doi.org/10.2196/53509 %U http://www.ncbi.nlm.nih.gov/pubmed/39150761 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e57382 %T Study of Postacute Sequelae of COVID-19 Using Digital Wearables: Protocol for a Prospective Longitudinal Observational Study %A El-Toukhy,Sherine %A Hegeman,Phillip %A Zuckerman,Gabrielle %A Das,Anirban Roy %A Moses,Nia %A Troendle,James %A Powell-Wiley,Tiffany M %+ Division of Intramural Research, National Institute on Minority Health and Health Disparities, National Institutes of Health, 11545 Rockville Pike, Rockville, MD, 20852, United States, 1 3015944743, sherine.el-toukhy@nih.gov %K postacute sequelae of COVID-19 %K wearable devices %K physiological parameters %K prospective observational study %K mobile phone %D 2024 %7 16.8.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Postacute sequelae of COVID-19 (PASC) remain understudied in nonhospitalized patients. Digital wearables allow for a continuous collection of physiological parameters such as respiratory rate and oxygen saturation that have been predictive of disease trajectories in hospitalized patients. Objective: This protocol outlines the design and procedures of a prospective, longitudinal, observational study of PASC that aims to identify wearables-collected physiological parameters that are associated with PASC in patients with a positive diagnosis. Methods: This is a single-arm, prospective, observational study of a cohort of 550 patients, aged 18 to 65 years, male or female, who own a smartphone or a tablet that meets predetermined Bluetooth version and operating system requirements, speak English, and provide documentation of a positive COVID-19 test issued by a health care professional within 5 days before enrollment. The primary end point is long COVID-19, defined as ≥1 symptom at 3 weeks beyond the first symptom onset or positive diagnosis, whichever comes first. The secondary end point is chronic COVID-19, defined as ≥1 symptom at 12 weeks beyond the first symptom onset or positive diagnosis. Participants must be willing and able to consent to participate in the study and adhere to study procedures for 6 months. Results: The first patient was enrolled in October 2021. The estimated year for publishing the study results is 2025. Conclusions: This is a fully decentralized study investigating PASC using wearable devices to collect physiological parameters and patient-reported outcomes. The study will shed light on the duration and symptom manifestation of PASC in nonhospitalized patient subgroups and is an exemplar of the use of wearables as population-level monitoring health tools for communicable diseases. Trial Registration: ClinicalTrials.gov NCT04927442; https://clinicaltrials.gov/study/NCT04927442 International Registered Report Identifier (IRRID): DERR1-10.2196/57382 %M 39150750 %R 10.2196/57382 %U https://www.researchprotocols.org/2024/1/e57382 %U https://doi.org/10.2196/57382 %U http://www.ncbi.nlm.nih.gov/pubmed/39150750 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e56189 %T The Internet-Based Intervention Strategies for Empowering Activities in Everyday Life: Qualitative Study of Experiences of Clients With Stroke %A Barcheus,Ida-Maria %A Ranner,Maria %A Månsson Lexell,Eva %A Jacobsson,Lars %A Larsson-Lund,Maria %+ Division of Health, Medicine and Rehabilitation-Occupational Therapy, Department of Health, Education and Technology, Luleå University of Technology, Luleå tekniska universitet, Luleå, 97187, Sweden, 46 0733379375, ida.maria.barcheus@ltu.se %K internet-based rehabilitation %K occupational therapy intervention %K rehabilitation %K self-management %K stroke %K active everyday life %K activity-based intervention %D 2024 %7 15.8.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: There is a need to enhance access to and support for self-management of activities in everyday life after a stroke. Internet-based solutions have the potential to contribute to this development. Consequently, an internet-based intervention called Strategies for Empowering Activities in Everyday Life (SEE) was developed. The intervention aims to assist clients in developing management strategies that promote a healthy distribution and balanced engagement in various activities performed in different places and with other people. To further support the development and feasibility of this intervention, more knowledge is needed about clients’ experiences during the intervention process. Objective: This study aims to explore and describe how clients with stroke experienced the SEE intervention process and whether participation in SEE influenced their experience of everyday life. Methods: Overall, 9 clients with stroke who received SEE participated in the study—4 (44%) women and 5 (56%) men aged 37 to 73 years. Qualitative interviews about experiences with SEE were conducted twice during the intervention process with each participant. The data were analyzed using the constant comparative method of grounded theory. Results: The participants’ experiences with the intervention process of SEE formed the core category, conceptualized as The relevance of and readiness for entering a change process in activities of everyday life differ among clients, constituting of two main categories: (1) an eye-opener providing agency for a change process and (2) never beginning a change process in activities in everyday life. The results showed that the relevance of and readiness for SEE differed between the participants. The experiences of 78% (7/9) of the participants reflected that the intervention process provided them with an agency to drive their own change process for activities in everyday life to promote health. Overall, 22% (2/9) of the participants refrained from entering a change process during SEE as they did not recognize any need for changes in their activities. When SEE was relevant and adopted as expected, the participants described it as an eye-opener for how they can alter their health based on how they distribute and spend their time on various activities. Conclusions: SEE has the potential to support clients’ development of self-management and to take an active role in influencing their engagement in activities in everyday life and health. This study identified necessary improvements in the educational program for professionals to enhance delivery and strengthen the therapeutic mechanisms of SEE for future research. To effectively implement internet-based interventions such as SEE, it is crucial to identify clients who express a need for self-management in activities and are ready to invest the effort required to adopt a change process. Furthermore, it is indicated that participants’ self-analysis of their everyday activities empowers them to adopt new self-management strategies, which can also benefit other interventions. %M 39146535 %R 10.2196/56189 %U https://formative.jmir.org/2024/1/e56189 %U https://doi.org/10.2196/56189 %U http://www.ncbi.nlm.nih.gov/pubmed/39146535 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e50075 %T Association of Wearable Device–Measured Step Volume and Variability With Blood Pressure in Older Chinese Adults: Mobile-Based Longitudinal Observational Study %A Xiao,Han %A Zhou,Zechen %A Ma,Yujia %A Li,Xiaoyi %A Ding,Kexin %A Dai,Xiaotong %A Chen,Dafang %+ Department of Epidemiology and Biostatistics, Peking University, 38 Xueyuan Road, Haidian, Beijing, 100191, China, 86 13701248872, hx624@ic.ac.uk %K older adults %K physical activity %K step volume %K step variability %K blood pressure %K wearable devices %K mHealth apps %K mobile health apps %K mobile phone %D 2024 %7 14.8.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: The paucity of evidence on longitudinal and consecutive recordings of physical activity (PA) and blood pressure (BP) under real-life conditions and their relationships is a vital research gap that needs to be addressed. Objective: This study aims to (1) investigate the short-term relationship between device-measured step volume and BP; (2) explore the joint effects of step volume and variability on BP; and (3) examine whether the association patterns between PA and BP varied across sex, hypertension status, and chronic condition status. Methods: This study used PA data of a prospective cohort of 3070 community-dwelling older adults derived from a mobile health app. Daily step counts, as a proxy of step volume, were derived from wearable devices between 2018 and 2022 and categorized into tertiles (low, medium, and high). Step variability was assessed using the SD of daily step counts. Consecutive daily step count recordings within 0 to 6 days preceding each BP measurement were analyzed. Generalized estimation equation models were used to estimate the individual and joint associations of daily step volume and variability with BP. Stratified analyses by sex, the presence of hypertension, and the number of morbidities were further conducted. Results: A total of 3070 participants, with a median age of 72 (IQR 67-77) years and 71.37% (2191/3070) women, were included. Participants walked a median of 7580 (IQR 4972-10,653) steps and 5523 (IQR 3590-7820) meters per day for a total of 592,597 person-days of PA monitoring. Our results showed that higher levels of daily step volume were associated with lower BP (systolic BP, diastolic BP, mean arterial pressure, and pulse pressure). Compared with participants with low step volume (daily step counts <6000/d) and irregular steps, participants with high step volume (≥9500/d) and regular steps showed the strongest decrease in systolic BP (–1.69 mm Hg, 95% CI –2.2 to –1.18), while participants with medium step volume (6000/d to <9500/d) and regular steps were associated with the lowest diastolic BP (–1.067 mm Hg, 95% CI –1.379 to –0.755). Subgroup analyses indicated generally greater effects on women, individuals with normal BP, and those with only 1 chronic disease, but the effect pattern was varied and heterogeneous between participants with different characteristics. Conclusions: Increased step volume demonstrated a substantial protective effect on BP among older adults with chronic conditions. Furthermore, the beneficial association between step volume and BP was enhanced by regular steps, suggesting potential synergistic protective effects of both increased step volume and step regularity. Targeting both step volume and variability through PA interventions may yield greater benefits in BP control, particularly among participants with hypertension and a higher chronic disease burden. %M 39141900 %R 10.2196/50075 %U https://www.jmir.org/2024/1/e50075 %U https://doi.org/10.2196/50075 %U http://www.ncbi.nlm.nih.gov/pubmed/39141900 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e56043 %T Leveraging Feedback From Families of Children With Autism to Create Digital Support for Service Navigation: Descriptive Study %A Burke,Meghan %A Li,Chak %A Cheung,Waifong Catherine %A Terol,Adriana Kaori %A Johnston,Amanda %A Schueller,Stephen M %+ Department of Special Education, Vanderbilt University, 110 Magnolia Circle, Nashville, TN, 37203, United States, 1 6155851420, meghan.burke@vanderbilt.edu %K human-centered design %K autism %K service access %K families %K digital support %K autistic children %K autistic %K children %K child %K app %K apps %K application %K applications %K digital tool %K tool %K tools %D 2024 %7 14.8.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: It is difficult for families to navigate and access services for their children with autism. Barriers to service access are compounded among families from low-resourced backgrounds. Objective: The purpose of our study was to explore the development of an app to facilitate access to services among families of children with autism from low-resourced backgrounds. Our specific aims were to explore feedback from an advisory board about the app and to explore feedback from navigators about the app. Methods: Via a multistage codevelopment process, we elicited feedback from 5 key parties: the research team, a community organization, the app development team, the advisory board, and family navigators. Collectively, 36 individuals provided feedback about the development of the app via individual interviews, focus groups, observations, and surveys. The key features of the app included a dashboard showing the service needs of the family and related resources, a messaging feature between the family, the navigator, and the supervisor, and a fidelity checklist and evaluation feature. Results: The advisory board provided feedback about the app to increase its user-friendliness, include the ability to develop an action plan, improve the identification of needed services, and add information about service providers. Navigators suggested that the app should connect navigators to one another, have a clearer purpose for the notes section, and reflect an easier log-in process. Navigators also wanted training to role-play using the app. After participating in a role play using the app, navigators reported significantly more satisfaction with the app and greater usefulness (P<.001). Conclusions: Our work sheds light on the importance of eliciting feedback from end users, especially users who are often overlooked by the research community and app developers. Further, it is important to elicit feedback in multiple ways to improve the app. %M 39141412 %R 10.2196/56043 %U https://formative.jmir.org/2024/1/e56043 %U https://doi.org/10.2196/56043 %U http://www.ncbi.nlm.nih.gov/pubmed/39141412 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55252 %T Improving the Well-Being of People With Advanced Cancer and Their Family Caregivers: Protocol for an Effectiveness-Implementation Trial of a Dyadic Digital Health Intervention (FOCUSau) %A Hudson,Peter %A Francis,Jill %A Cohen,Joachim %A Kapp,Suzanne %A De Abreu Lourenco,Richard %A Beatty,Lisa %A Gray,Kathleen %A Jefford,Michael %A Juraskova,Ilona %A Northouse,Laurel %A de Vleminck,Aline %A Chang,Sungwon %A Yates,Patsy %A Athan,Sophy %A Baptista,Shaira %A Klaic,Marlena %A Philip,Jennifer %+ Centre for Palliative Care, c/o St Vincent’s Hospital and The University of Melbourne, 41 Victoria Parade, Fitzroy, Melbourne, VIC 3065, Australia, 61 394160000, phudson@unimelb.edu.au %K advanced cancer %K clinical trial %K digital health intervention %K palliative care %K health economics %K implementation science %K wellbeing %K well-being %K cancer %K family caregiver %K family caregivers %K caregivers %K caregiver %K digital health %K quality of life %K dyad %K self-administered %K web-based intervention %K web-based %K Australian %K Australia %K efficacy %K cost-effectiveness %K psychoeducation %D 2024 %7 13.8.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Advanced cancer significantly impacts patients’ and family caregivers’ quality of life. When patients and caregivers are supported concurrently as a dyad, the well-being of each person is optimized. Family, Outlook, Communication, Uncertainty, Symptom management (FOCUS) is a dyadic, psychoeducational intervention developed in the United States, shown to improve the well-being and quality of life of patients with advanced cancer and their primary caregivers. Originally, a nurse-delivered in-person intervention, FOCUS has been adapted into a self-administered web-based intervention for European delivery. Objective: The aims of this study are to (1) adapt FOCUS to the Australian context (FOCUSau); (2) evaluate the effectiveness of FOCUSau in improving the emotional well-being and self-efficacy of patients with advanced cancer and their primary caregiver relative to usual care control group; (3) compare health care use between the intervention and control groups; and (4) assess the acceptability, feasibility, and scalability of FOCUSau in order to inform future maintainable implementation of the intervention within the Australian health care system. Methods: FOCUS will be adapted prior to trial commencement, using an iterative stakeholder feedback process to create FOCUSau. To examine the efficacy and cost-effectiveness of FOCUSau and assess its acceptability, feasibility, and scalability, we will undertake a hybrid type 1 implementation study consisting of a phase 3 (clinical effectiveness) trial along with an observational implementation study. Participants will include patients with cancer who are older than 18 years, able to access the internet, and able to identify a primary support person or caregiver who can also be approached for participation. The sample size consists of 173 dyads in each arm (ie, 346 dyads in total). Patient-caregiver dyad data will be collected at 3 time points—baseline (T0) completed prerandomization; first follow-up (T1; N=346) at 12 weeks post baseline; and second follow-up (T2) at 24 weeks post baseline. Results: The study was funded in March 2022. Recruitment commenced in July 2024. Conclusions: If shown to be effective, this intervention will improve the well-being of patients with advanced cancer and their family caregivers, regardless of their location or current level of health care support. Trial Registration: ClinicalTrials.gov NCT06082128; https://clinicaltrials.gov/study/NCT06082128 International Registered Report Identifier (IRRID): PRR1-10.2196/55252 %M 39137414 %R 10.2196/55252 %U https://www.researchprotocols.org/2024/1/e55252 %U https://doi.org/10.2196/55252 %U http://www.ncbi.nlm.nih.gov/pubmed/39137414 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53909 %T Effect of a Mobile Health–Based Remote Interaction Management Intervention on the Quality of Life and Self-Management Behavior of Patients With Low Anterior Resection Syndrome: Randomized Controlled Trial %A Zhou,Peng %A Li,Hui %A Pang,Xueying %A Wang,Ting %A Wang,Yan %A He,Hongye %A Zhuang,Dongmei %A Zhu,Furong %A Zhu,Rui %A Hu,Shaohua %+ Department of Nursing, the First Affiliated Hospital of Anhui Medical University, 218 Jixi Road, Hefei, 230009, China, 86 62922005, hushaohua1003@126.com %K mHealth %K low anterior resection syndrome %K quality of life %K sphincter-preserving surgery %K randomized controlled trial %K mobile health %K mobile phone %D 2024 %7 13.8.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: People who undergo sphincter-preserving surgery have high rates of anorectal functional disturbances, known as low anterior resection syndrome (LARS). LARS negatively affects patients’ quality of life (QoL) and increases their need for self-management behaviors. Therefore, approaches to enhance self-management behavior and QoL are vital. Objective: This study aims to assess the effectiveness of a remote digital management intervention designed to enhance the QoL and self-management behavior of patients with LARS. Methods: From July 2022 to May 2023, we conducted a single-blinded randomized controlled trial and recruited 120 patients with LARS in a tertiary hospital in Hefei, China. All patients were randomly assigned to the intervention group (using the “e-bowel safety” applet and monthly motivational interviewing) or the control group (usual care and an information booklet). Our team provided a 3-month intervention and followed up with all patients for an additional 3 months. The primary outcome was patient QoL measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. The secondary outcomes were evaluated using the Bowel Symptoms Self-Management Behaviors Questionnaire, LARS score, and Perceived Social Support Scale. Data collection occurred at study enrollment, the end of the 3-month intervention, and the 3-month follow-up. Generalized estimating equations were used to analyze changes in all outcome variables. Results: In the end, 111 patients completed the study. In the intervention group, 5 patients withdrew; 4 patients withdrew in the control group. Patients in the intervention group had significantly larger improvements in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 total score (mean difference 11.51; 95% CI 10.68-12.35; Cohen d=1.73) and Bowel Symptoms Self-Management Behaviors Questionnaire total score (mean difference 8.80; 95% CI 8.28-9.32; Cohen d=1.94) than those in the control group. This improvement effect remained stable at 3-month follow-up (mean difference 14.47; 95% CI 13.65-15.30; Cohen d=1.58 and mean difference 8.85; 95% CI 8.25-9.42; Cohen d=2.23). The LARS score total score had significantly larger decreases after intervention (mean difference –3.28; 95% CI –4.03 to –2.54; Cohen d=–0.39) and at 3-month follow-up (mean difference –6.69; 95% CI –7.45 to –5.93; Cohen d=–0.69). The Perceived Social Support Scale total score had significantly larger improvements after intervention (mean difference 0.47; 95% CI 0.22-0.71; Cohen d=1.81). Conclusions: Our preliminary findings suggest that the mobile health–based remote interaction management intervention significantly enhanced the self-management behaviors and QoL of patients with LARS, and the effect was sustained. Mobile health–based remote interventions become an effective method to improve health outcomes for many patients with LARS. Trial Registration: Chinese Clinical Trial Registry ChiCTR2200061317; https://tinyurl.com/tmmvpq3 %M 39137413 %R 10.2196/53909 %U https://www.jmir.org/2024/1/e53909 %U https://doi.org/10.2196/53909 %U http://www.ncbi.nlm.nih.gov/pubmed/39137413 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53598 %T A Transdiagnostic Video-Based Internet Intervention (Uni Virtual Clinic-Lite) to Improve the Mental Health of University Students: Randomized Controlled Trial %A Farrer,Louise M %A Jackson,Hayley M %A Gulliver,Amelia %A Calear,Alison L %A Leach,Liana %A Hasking,Penelope %A Katruss,Natasha %A Batterham,Philip J %+ Centre for Mental Health Research, National Centre for Epidemiology and Population Health, The Australian National University, 63 Eggleston Rd, Canberra, 2601, Australia, 61 6125 8859, louise.farrer@anu.edu.au %K university students %K internet-based intervention %K randomized controlled trial %K mental health %K transdiagnostic %D 2024 %7 13.8.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Numerous studies have demonstrated the effectiveness of digital interventions for improving the mental health of university students. However, low rates of engagement with these interventions are an ongoing challenge and can compromise effectiveness. Brief, transdiagnostic, web-based video interventions are capable of targeting key mental health and related issues affecting university students and may be more engaging and accessible for this population. Objective: This study used a 2-arm randomized controlled trial to evaluate the effectiveness of Uni Virtual Clinic-Lite (UVC-Lite), a fully automated, transdiagnostic, web-based video intervention, relative to an attention-control condition. The primary outcomes were symptoms of depression and generalized anxiety disorder. The secondary outcomes included psychological distress, social anxiety symptoms, body appreciation, quality of life, well-being, functioning, general self-efficacy, academic self-efficacy, and help seeking. Program use (intervention uptake and engagement) and satisfaction were also assessed. Methods: University students (n=487) with mild to moderate symptoms of distress were recruited from universities across Australia and randomly allocated to receive access to the UVC-Lite intervention or an attention-control condition targeting general health for a period of 6 weeks. UVC-Lite includes 12 modules, each comprising a brief animated video and an accompanying exercise. Of the 12 modules, 7 also included a brief symptom screening quiz. Outcomes were assessed at baseline, postintervention, and 3- and 6-months postintervention. Results: The primary and secondary outcomes were analyzed on an intention-to-treat basis using mixed models repeated measures ANOVA. The intervention was not found to be effective relative to the control condition on any of the primary or secondary outcomes. While 67.9% (114/168) of participants accessed at least 1 module of the intervention, module completion was extremely low. Subgroup analyses among those who engaged with the program (completed at least 1 video) and those with higher baseline distress (Distress Questionnaire-5 score ≥15) did not reveal any differences between the conditions over time. However, uptake (accessing at least 1 video) and engagement (completing at least 1 video) were higher among those with higher baseline symptoms. Satisfaction with the intervention was high. Conclusions: The UVC-Lite intervention was not effective relative to a control program, although it was associated with high satisfaction among students and was not associated with symptom deterioration. Given the challenges faced by universities in meeting demand for mental health services, flexible and accessible interventions such as UVC-Lite have the potential to assist students to manage symptoms of mental health problems. However, low uptake and engagement (particularly among students with lower levels of symptomatology) are significant challenges that require further attention. Future studies should examine the effectiveness of the intervention in a more highly symptomatic sample, as well as implementation pathways to optimize effective engagement with the intervention. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621000375853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380146 %M 39137012 %R 10.2196/53598 %U https://www.jmir.org/2024/1/e53598 %U https://doi.org/10.2196/53598 %U http://www.ncbi.nlm.nih.gov/pubmed/39137012 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e39554 %T Exploring the Impact of a Sleep App on Sleep Quality in a General Population Sample: Pilot Randomized Controlled Trial %A Armitage,Bianca Tanya %A Potts,Henry W W %A Irwin,Michael R %A Fisher,Abi %+ Department of Behavioural Science and Health, University College London, 1-19 Torrington Place, London, WC1E 7HB, United Kingdom, 44 020 7679 1722, abigail.fisher@ucl.ac.uk %K sleep %K mobile app %K app optimization %K intervention %K smartphone %K general population %K mindfulness %K cognitive behavioral therapy %K CBT %K mobile phone %D 2024 %7 13.8.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: A third of adults in Western countries have impaired sleep quality. A possible solution involves distributing sleep aids through smartphone apps, but most empirical studies are limited to small pilot trials in distinct populations (eg, soldiers) or individuals with clinical sleep disorders; therefore, general population data are required. Furthermore, recent research shows that sleep app users desire a personalized approach, offering an individually tailored choice of techniques. One such aid is Peak Sleep, a smartphone app based on scientifically validated principles for improving sleep quality, such as mindfulness meditation and cognitive behavioral therapy. Objective: We aimed to test the impact of the smartphone app Peak Sleep on sleep quality and collect user experience data to allow for future app development. Methods: This was a 2-arm pilot randomized controlled trial. Participants were general population adults in the United Kingdom (aged ≥18 years) who were interested in improving their sleep quality and were not undergoing clinical treatment for sleep disorder or using sleep medication ≥1 per week. Participants were individually randomized to receive the intervention (3 months of app use) versus a no-treatment control. The intervention involved free access to Peak Sleep, an app that offered a choice of behavioral techniques to support better sleep (mindfulness, cognitive behavioral therapy, and acceptance commitment therapy). The primary outcome was sleep quality assessed using the Insomnia Severity Index at baseline and 1-, 2-, and 3-month follow-ups. Assessments were remote using web-based questionnaires. Objective sleep data collection using the Oura Ring (Ōura Health Oy) was planned; however, because the COVID-19 pandemic lockdowns began just after recruitment started, this plan could not be realized. Participant engagement with the app was assessed using the Digital Behavior Change Intervention Engagement Scale and qualitative telephone interviews with a subsample. Results: A total of 101 participants were enrolled in the trial, and 21 (21%) were qualitatively interviewed. Sleep quality improved in both groups over time, with Insomnia Severity Index scores of the intervention group improving by a mean of 2.5 and the control group by a mean of 1.6 (between-group mean difference 0.9, 95% CI –2.0 to 3.8), with was no significant effect of group (P=.91). App users’ engagement was mixed, with qualitative interviews supporting the view of a polarized sample who either strongly liked or disliked the app. Conclusions: In this trial, self-reported sleep improved over time in both intervention and control arms, with no impact by group, suggesting no effect of the sleep app. Qualitative data suggested polarized views on liking or not liking the app, features that people engaged with, and areas for improvement. Future work could involve developing the app features and then testing the app using objective measures of sleep in a larger sample. Trial Registration: ClinicalTrials.gov NCT04487483; https://www.clinicaltrials.gov/study/NCT04487483 %M 39137016 %R 10.2196/39554 %U https://formative.jmir.org/2024/1/e39554 %U https://doi.org/10.2196/39554 %U http://www.ncbi.nlm.nih.gov/pubmed/39137016 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e51570 %T Development and Implementation of Postdischarge Text Messages to Adolescents With Suicidal Thoughts and Behaviors Through Caring Contacts: Implementation Study %A Thomas,Glenn V %A Camacho,Elena %A Masood,Fatimah A %A Huang,Yungui %A Valleru,Jahnavi %A Bridge,Jeffrey A %A Ackerman,John %+ Behavioral Health Services, Nationwide Children’s Hospital, 444 Butterfly Gardens Dr., 2nd Fl., Columbus, OH, 43215, United States, 1 6143550814, John.Ackerman@nationwidechildrens.org %K mental health %K suicide prevention %K adolescent %K caring contacts %K mHealth %K Zero Suicide %K quality improvement %K care transitions %K safety plan %K behavioral health %K mobile phone %D 2024 %7 13.8.2024 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Youth suicide is a pressing public health concern, and transitions in care after a suicidal crisis represent a period of elevated risk. Disruptions in continuity of care and emotional support occur frequently. “Caring contacts” validating messages post discharge have the potential to enhance connections with patients and have been shown to improve outcomes. More recently, positive outcomes have been noted using caring contact text messages (SMS and MMS), which hold promise for engaging patients in a pediatric setting, but there are few studies describing the large-scale implementation of such an approach. Objective: This study aims to describe the process of developing and implementing automated caring contacts within a quality improvement framework, using a standardized series of supportive texts and images, for adolescents discharged from high-acuity programs at a large midwestern pediatric hospital. We describe lessons learned, including challenges and factors contributing to success. Methods: We implemented the caring contacts intervention in 3 phases. Phase 1 entailed developing supportive statements and images designed to promote hope, inclusivity, and connection in order to create 2 sets of 8 text messages and corresponding images. Phase 2 included piloting caring contacts manually in the hospital’s Psychiatric Crisis Department and Inpatient Psychiatry Unit and assessing the feasibility of implementation in other services, as well as developing workflows and addressing legal considerations. Phase 3 consisted of implementing an automated process to scale within 4 participating hospital services and integrating enrollment into the hospital’s electronic medical records. Process outcome measures included staff compliance with approaching and enrolling eligible patients and results from an optional posttext survey completed by participants. Results: Compliance data are presented for 4062 adolescent patients eligible for caring contacts. Overall, 88.65% (3601/4062) of eligible patients were approached, of whom 52.43% (1888/3601) were enrolled. In total, 94.92% (1792/1888) of enrolled participants completed the program. Comparisons of the patients eligible, approached, enrolled, and completed are presented. Primary reasons for eligible patients declining include not having access to a mobile phone (686/1705, 40.23%) and caregivers preferring to discuss the intervention at a later time (754/1705, 44.22%). The majority of patients responding to the optional posttext survey reported that the texts made them feel moderately to very hopeful (219/264, 83%), supported (232/264, 87.9%), that peers would be helped by these texts (243/264, 92%), and that they would like to keep receiving texts given the option (227/264, 86%). Conclusions: This study describes the successful implementation of automated postdischarge caring contacts texts to scale with an innovative use of images and demonstrates how a quality improvement methodology resulted in a more effective and efficient process. This paper also highlights the potential for technology to enhance care for at-risk youth and create more accessible, inclusive, and sustainable prevention strategies. %M 39137019 %R 10.2196/51570 %U https://pediatrics.jmir.org/2024/1/e51570 %U https://doi.org/10.2196/51570 %U http://www.ncbi.nlm.nih.gov/pubmed/39137019 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e47116 %T The Impact of a Gamified Intervention on Daily Steps in Real-Life Conditions: Retrospective Analysis of 4800 Individuals %A Mazéas,Alexandre %A Forestier,Cyril %A Harel,Guillaume %A Duclos,Martine %A Chalabaev,Aïna %+ Laboratoire Sport et Environnement Social (SENS), Université Grenoble Alpes, 1741 Rue de la Piscine, Grenoble, 38000, France, 33 476635081, alexandre.mazeas@univ-grenoble-alpes.fr %K behavior change %K daily steps %K exercise %K gamification %K intervention %K mHealth %K mobile health %K mobile phone %K physical activity %K real world data %K retrospective %K self-determination theory %K step %K steps %D 2024 %7 12.8.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital interventions integrating gamification features hold promise to promote daily steps. However, results regarding the effectiveness of this type of intervention are heterogeneous and not yet confirmed in real-life contexts. Objective: This study aims to examine the effectiveness of a gamified intervention and its potential moderators in a large sample using real-world data. Specifically, we tested (1) whether a gamified intervention enhanced daily steps during the intervention and follow-up periods compared to baseline, (2) whether this enhancement was higher in participants in the intervention than in nonparticipants, and (3) what participant characteristics or intervention parameters moderated the effect of the program. Methods: Data from 4819 individuals who registered for a mobile health Kiplin program between 2019 and 2022 were retrospectively analyzed. In this intervention, participants could take part in one or several games in which their daily step count was tracked, allowing individuals to play with their overall activity. Nonparticipants were people who registered for the program but did not take part in the intervention and were considered as a control group. Daily step counts were measured via accelerometers embedded in either commercial wearables or smartphones of the participants. Exposure to the intervention, the intervention content, and participants’ characteristics were included in multilevel models to test the study objectives. Results: Participants in the intervention group demonstrated a significantly greater increase in mean daily steps from baseline than nonparticipants (P<.001). However, intervention effectiveness depended on participants’ initial physical activity. The daily steps of participants with <7500 baseline daily steps significantly improved from baseline both during the Kiplin intervention (+3291 daily steps) and the follow-up period (+945 daily steps), whereas participants with a higher baseline had no improvement or significant decreases in daily steps after the intervention. Age (P<.001) and exposure (P<.001) positively moderated the intervention effect. Conclusions: In real-world settings and among a large sample, the Kiplin intervention was significantly effective in increasing the daily steps of participants from baseline during intervention and follow-up periods compared to nonparticipants. Interestingly, responses to the intervention differed based on participants’ initial steps, with the existence of a plateau effect. Drawing on the insights of self-determination theory, we can assume that the effect of gamification could depend of the initial motivation and activity of participants. %M 39133533 %R 10.2196/47116 %U https://www.jmir.org/2024/1/e47116 %U https://doi.org/10.2196/47116 %U http://www.ncbi.nlm.nih.gov/pubmed/39133533 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e53355 %T Efficacy of a Web-Based Home Blood Pressure Monitoring Program in Improving Predialysis Blood Pressure Control Among Patients Undergoing Hemodialysis: Randomized Controlled Trial %A Chen,Tingting %A Zhao,Wenbo %A Pei,Qianqian %A Chen,Yanru %A Yin,Jinmei %A Zhang,Min %A Wang,Cheng %A Zheng,Jing %K hemodialysis %K hypertension %K home blood pressure monitoring %K eHealth %K randomized controlled trial %D 2024 %7 9.8.2024 %9 %J JMIR Mhealth Uhealth %G English %X Background: Hypertension is highly prevalent among patients undergoing hemodialysis, with a significant proportion experiencing poorly controlled blood pressure (BP). Digital BP management in this population has been underused. Objective: This study aimed to explore the efficacy of a web-based home BP monitoring (HBPM) program in improving predialysis BP control and enhancing knowledge, perception, and adherence to HBPM among patients with hypertension undergoing hemodialysis. Methods: A multicenter, open-label, randomized controlled trial was conducted at 2 hemodialysis units. Patients were randomly allocated in a 1:1 ratio to either the web-based HBPM program as the intervention group or to usual care as the control group over a 6-month period. The primary outcomes were the predialysis BP control rate, defined as less than 140/90 mm Hg, and the predialysis systolic and diastolic BP, assessed from baseline to the 6-month follow-up. Secondary outcomes included patient knowledge, perception, and adherence to HBPM, evaluated using the HBPM Knowledge Questionnaire, HBPM Perception Scale, and HBPM Adherence Scale, respectively. A generalized estimating equations analysis was used to analyze the primary outcomes in the intention-to-treat analysis. Results: Of the 165 patients enrolled in the program (n=84, 50.9% in the web-based HBPM group and n=81, 49.1% in the control group), 145 (87.9%) completed the follow-up assessment. During the follow-up period, 11 instances of hypotension occurred in 9 patients in the web-based HBPM group, compared to 15 instances in 14 patients in the control group. The predialysis BP control rate increased from 30% (25/84) to 48% (40/84) in the web-based HBPM group after the 6-month intervention, whereas in the control group, it decreased from 37% (30/81) to 25% (20/81; χ22=16.82, P<.001; odds ratio 5.11, 95% CI 2.14-12.23, P<.001). The web-based HBPM group demonstrated a significant reduction after the 6-month intervention in the predialysis systolic BP (t163=2.46, P=.02; β=−6.09, 95 % CI −10.94 to −1.24, P=.01) and the predialysis diastolic BP (t163=3.20, P=.002; β=−4.93, 95% CI −7.93 to −1.93, P=.001). Scores on the HBPM Knowledge Questionnaire (t163=−9.18, P<.001), HBPM Perception Scale (t163=−10.65, P<.001), and HBPM Adherence Scale (t163=−8.04, P<.001) were significantly higher after 6 months of intervention. Conclusions: The implementation of a web-based HBPM program can enhance predialysis BP control and the knowledge, perception, and adherence to HBPM among patients undergoing hemodialysis. This web-based HBPM program should be promoted in appropriate clinical settings. Trial Registration: China Clinical Trial Registration Center ChiCTR2100051535; https://www.chictr.org.cn/showproj.html?proj=133286 %R 10.2196/53355 %U https://mhealth.jmir.org/2024/1/e53355 %U https://doi.org/10.2196/53355 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53926 %T Sex Differences in Pain Sensitivity in a Dutch Cohort: Cross-Sectional and Web-Based Multidimensional Study %A Smits,Rachel J H %A van der Wal,Selina E I %A van Boekel,Regina L M %A Timmerman,Hans %A Bronkhorst,Ewald M %A Abrar,Diana %A Vissers,Kris C P %A Blaney Davidson,Esmeralda N %A Steegers,Monique A H %+ Department of Anesthesiology, Pain and Palliative Medicine, Radboud university medical center, Postbus 9101, Nijmegen, 6500 HB, Netherlands, 31 6 29698822, rachel.smits@radboudumc.nl %K pain sensitivity %K pain sensitivity questionnaire %K chronic pain %K digital interventions %K mobile health %K film %K sex %K Dutch population %K personalized medicine %K individualized care %D 2024 %7 9.8.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Sex is an important factor influencing the development and treatment of chronic pain, but the extent of its influence is still unclear. Other demographic factors as well as nonpharmacological interventions might influence pain sensitivity differently in men and women. Objective: In this study, we aimed to investigate the influence of sex and other demographic, lifestyle, behavioral, clinical, and environmental factors on pain sensitivity in the Dutch population. Different films were used to investigate how they would impact pain sensitivity and what influence sex and other variables have on the effect of this simple intervention. Methods: We performed a study consisting of 2 parts: (1) a cross-sectional research to investigate pain sensitivity differences between men and women and the influence of other demographic variables on the pain sensitivity in a Dutch cohort and (2) an internet intervention study to determine whether a short film could skew pain sensitivity. Results: All respondents filled in a web-based demographic questionnaire and were randomized into 4 groups. The control group filled in the Pain Sensitivity Questionnaire without watching a preliminary film. A cross-sectional analysis was performed in the control group (n=1746). The other 3 groups watched short films: one group watched a film with scenes of nature (n=2650), another group watched a film on laughing people (n=2735), and the last group watched a film on physically painful events (n=2708). Immediately after the film viewing, participants were directed to the Pain Sensitivity Questionnaire to measure their pain sensitivity. The Pain Sensitivity Questionnaire score was stated as a mean per question on the numeric rating scale from 0-1. The cross-sectional study revealed no significant differences between men and women but showed male-female differences in the Pain Sensitivity Questionnaire when specific background factors were present. Watching a short film had a positive impact on the pain sensitivity of the respondents who had chronic pain, with a higher effect observed in female respondents. Conclusions: Scientists performing pain research need to account for factors that can influence the outcome of their study and be aware that these factors can be sex-dependent, and pain sensitivity should be analyzed accordingly. Even relatively small interventions such as watching a film can impact pain sensitivity, especially in respondents with current chronic pain. This effect can vary as well when different background factors are present. Our findings warrant further explorations of the possibilities that simple interventions bring for patients in personalized medicine. Trial Registration: Landelijk Trial Register NTR-new NL8182; https://onderzoekmetmensen.nl/en/trial/29537 %M 39121479 %R 10.2196/53926 %U https://www.jmir.org/2024/1/e53926 %U https://doi.org/10.2196/53926 %U http://www.ncbi.nlm.nih.gov/pubmed/39121479 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e52428 %T Feasibility and Acceptability of a Mobile Health Exercise Intervention for Inactive Adults: 3-Arm Randomized Controlled Pilot Trial %A Dawson,Jacqueline Kiwata %A Ede,Alison %A Phan,Madeleine %A Sequeira,Alec %A Teng,Hsiang-Ling %A Donlin,Ayla %+ Department of Physical Therapy, California State University, Long Beach, ET-130, 1250 Bellflower Boulevard, Long Beach, CA, 90840, United States, 1 5629857139, jacqueline.dawson@csulb.edu %K digital health %K physical activity %K user experience %K heart rate monitor %K group exercise %K mHealth %K wearable %K group exercise %K feasibility %K acceptability %K mobile health %K mobile health exercise %K exercise %K adults %K randomized controlled trial %K exercise program %K support %K wearables %K screening %K effectiveness %K videoconference %D 2024 %7 9.8.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Objective monitoring of self-directed physical activity (PA) is a common approach used in both fitness and health settings to promote exercise behavior, but adherence has been poor. Newer mobile health (mHealth) technologies could be a cost-effective approach to broadening accessibility and providing support for PA behavior change; yet, the optimal method of delivery of such interventions is still unclear. Objective: This study aimed to determine the feasibility and acceptability of an mHealth exercise intervention delivered in combination with objective monitoring in 3 ways: health education emails, asynchronous exercise videos, or synchronous videoconference exercise classes. Methods: Physically inactive (<30 min/wk) adults (cisgender women aged 31.5, SD 11.3 years, cisgender men aged 34.1, SD 28.9 years, and nonbinary individuals aged 22.0, SD 0 years) were randomized (1:1:1) to 8 weeks of increasing PA behavioral support: level 1 (health education+objective monitoring, n=26), level 2 (asynchronous contact, level 1+prerecorded exercise videos, n=30), or level 3 (synchronous contact, level 1+videoconference group exercise, n=28). Participants used a heart rate monitor during exercise and a mobile app for interaction. Primary outcomes were feasibility (accrual, retention, and adherence) and acceptability (user experience survey). Secondary outcomes assessed at baseline and 8 weeks included resting heart rate, self-reported PA, and quality of life. The exercise dose was evaluated throughout the intervention. Results: Between August 2020 and August 2021, 204 adults were screened for eligibility. Out of 135 eligible participants, 84 (62%) enrolled in the study. Retention was 50% (13/26) in level 1, 60% (18/30) in level 2 and 82% (23/28) in level 3, while adherence was 31% (8/26) in level 1, 40% (12/30) in level 2 and 75% (21/28) in level 3. A total of 83% (70/84) of the study sample completed the intervention, but low response rates (64%, 54/84) were observed postintervention at week-8 assessments. Program satisfaction was highest in participants receiving exercise videos (level 2, 80%, 8/10) or exercise classes (level 3, 80%, 12/15), while only 63% (5/8) of level 1 reported the program as enjoyable. Level 3 was most likely to recommend the program (87%, 13/15), compared to 80% (8/10) in level 2 and 46% (5/8) in level 1. Self-reported PA significantly increased from baseline to intervention in level 3 (P<.001) and level 2 (P=.003), with no change in level 1. Level 3 appeared to exercise at higher doses throughout the intervention. Conclusions: Only the videoconference exercise class intervention met feasibility criteria, although postintervention response rates were low across all groups. Both videoconference and prerecorded videos had good acceptability, while objective monitoring and health education alone were not feasible or acceptable. Future studies are needed to examine the effectiveness of videoconference exercise interventions on health-related outcomes during nonpandemic times and how asynchronous interventions might maximize adherence. Trial Registration: ClinicalTrials.gov NCT05192421; https://clinicaltrials.gov/study/NCT05192421 %R 10.2196/52428 %U https://formative.jmir.org/2024/1/e52428 %U https://doi.org/10.2196/52428 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53145 %T Remote Exercise Training Intervention During the COVID-19 Pandemic: Randomized Controlled Trial %A Philippi,Keito F A %A Zeier,Peter %A Brahmer,Alexandra %A Neuberger,Elmo W I %A Sandner,Magdalena %A Hagenah,Matthias %A Porten,Thilo %A Lenz,Regina %A Ochmann,David T %A Wedekink,Florian %A Wischhusen,Jörg %A Lutz,Beat %A Lieb,Klaus %A Wessa,Michèle %A Simon,Perikles %+ Department of Sports Medicine, Disease Prevention and Rehabilitation, Institute of Sports Science, Johannes Gutenberg-University Mainz, Albert-Schweitzer-Straße 22, Mainz, 55128, Germany, 49 6131 3923531, simonpe@uni-mainz.de %K physical exercise %K web-based %K COVID-19 %K lockdown %K aerobic capacity %K depression %K feasibility %K aerobic %K anxiety %K randomized controlled trial %K prepandemic cohort %K mental health %K pandemic %K remote exercise %K intervention %K pre-COVID-19 %K lockdown cohort %K pandemic-related %K adult %K adults %D 2024 %7 8.8.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Societal measures to contain the spread of COVID-19 (eg, lockdown and contact restrictions) have been associated with decreased health and well-being. A multitude of prepandemic studies identified the beneficial effects of physical exercise on both physical and mental health. Objective: We report on the feasibility of a remote physical exercise intervention and its stress-buffering potential in 2 untrained cohorts: a pre–COVID-19 cohort that completed the intervention in 2019 and a lockdown cohort that started the intervention shortly before pandemic-related restrictions were implemented. Methods: In a randomized controlled trial, participants were assigned to either an intervention group (IG; pre–COVID-19 cohort: n=7 and lockdown cohort: n=9) or a control group (CG; pre–COVID-19 cohort: n=6 and lockdown cohort: n=6). IG participants received weekly individualized training recommendations delivered via web-based support. The intervention period was initially planned for 8 weeks, which was adhered to in the pre–COVID-19 cohort (mean 8.3, SD 0.5 weeks) but was extended to an average of 17.7 (SD 2.0) weeks in the lockdown cohort. Participants’ health parameters were assessed before and after the intervention: aerobic capacity was measured as peak oxygen uptake (VO2peak) via cardiopulmonary exercise testing. Depressive symptoms were scored via the depression subscale of the Brief Symptom Inventory-18. Results: Dropout rates were low in both cohorts in the IG (pre–COVID-19 cohort: n=0, 0% and lockdown cohort: n=2, 16.7%) and the CG (pre–COVID-19 cohort: n=0, 0% and lockdown cohort: n=2, 20%). The mean adherence to the training sessions of the IG for both cohorts was 84% (pre–COVID-19 cohort: SD 5.5% and lockdown cohort: SD 11.6%). Aligned rank transform ANOVAs in the lockdown cohort indicated deterioration of VO2peak and depressive symptoms from before to after the intervention in the CG but no longitudinal changes in the IG. Analyses in the pre–COVID-19 cohort revealed significant increases in VO2peak for the IG compared to the CG (P=.04) but no intervention effects on depressive symptoms. Conclusions: With low dropout rates and high adherence, the remote intervention was feasible for healthy adults under regular conditions and in the face of pandemic-related stressors. Moreover, our results hint at a stress-buffering effect as well as a buffering of a lockdown-induced deconditioning of remote physical exercise interventions in the pandemic scenario, which can be used in future studies to overcome equally stressful periods of life. However, due to limited statistical power, these findings should be replicated in similar scenarios. Trial Registration: German Clinical Trials Register DRKS00018078; https://drks.de/search/en/trial/DRKS00018078 %M 39116428 %R 10.2196/53145 %U https://www.jmir.org/2024/1/e53145 %U https://doi.org/10.2196/53145 %U http://www.ncbi.nlm.nih.gov/pubmed/39116428 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e58580 %T Protective Assets Reinforced With Integrated Care and Technology (PARITY): Protocol for a Randomized Controlled Trial %A Mollard,Elizabeth %A Cooper Owens,Deirdre %A Bach,Christina %A Gaines,Cydney %A Maloney,Shannon %A Moore,Tiffany %A Wichman,Christopher %A Shah,Neel %A Balas,Michele %+ College of Nursing, University of Nebraska Medical Center, 4111 Dewey Ave, Omaha, NE, 68198, United States, 1 402 472 3665, elizabeth.mollard@unmc.edu %K maternal health %K health disparities %K doula %K African American %K mobile phone %D 2024 %7 8.8.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Black women are significantly more likely to experience severe maternal morbidity and are 3 times as likely to die from pregnancy-related causes compared to White women. Using a strengths-based wellness approach within an integrated supportive care program provided by a community doula could offer pragmatic solutions for Black maternal disparities. The Protective Assets Reinforced with Integrated Care and Technology (PARITY) program consists of a wellness technology platform, including informational links to wellness content and reinforcing motivational SMS text messages, as well as community-based doula support delivered both in person and through the technology platform to improve Black maternal wellness. Objective: This pilot randomized controlled trial (RCT) and mixed methods evaluation aims to (1) determine the feasibility and acceptability of the PARITY intervention; (2) investigate the preliminary efficacy of the PARITY intervention on clinical outcomes (maternal blood pressure, gestational weight gain, and cesarean birth); and (3) investigate changes to wellness behavioral outcomes (nutrition, physical activity, sleep, and health care adherence) and empowered strengths (self-efficacy, social support, motivation, resilience, problem-solving, and self-regulation) in the intervention group compared to a control group. Methods: A 2-arm RCT and mixed methods evaluation will be conducted. Overall, 60 Black pregnant individuals will be randomized in a ratio of 1:1 to either the intervention or informational control group. Participants in the intervention group will receive access to the technology platform over a 12-week period that ends before birth. Intervention participants will be assigned a doula interventionist, who will meet with them 4 times during the intervention. All participants (intervention and control) will receive a referral for a birth doula at no cost, printed materials about having a healthy pregnancy, and community resources. Feasibility and acceptability will be assessed at the end of the program. Measures will be obtained at baseline (20-28 weeks), the 36th week of pregnancy, birth, and 6-12 weeks post partum. Summary statistics and distribution plots will be used to describe measured variables at each time point. A generalized linear mixed model with a shared random component will be used to analyze the effects of PARITY on clinical, wellness behavioral, and empowered strength outcomes, including baseline nutrition, physical activity, and sleep measures as covariates. For significant effects, post hoc contrasts will be adjusted using the Holm method to maintain comparison-wise error at or <.05. Missing data will be addressed using a pattern-mixture model. Results: The National Institute of Nursing Research funded this pilot RCT. Recruitment, enrollment, and data collection are ongoing, and the estimated study completion date is October 2024. Conclusions: The expected results of this study will provide the feasibility and preliminary efficacy of the PARITY intervention, to be used in a larger trial with a 12-month PARITY program intervention. Trial Registration: ClinicalTrials.gov NCT05802615; https://clinicaltrials.gov/study/NCT05802615 International Registered Report Identifier (IRRID): DERR1-10.2196/58580 %M 39116423 %R 10.2196/58580 %U https://www.researchprotocols.org/2024/1/e58580 %U https://doi.org/10.2196/58580 %U http://www.ncbi.nlm.nih.gov/pubmed/39116423 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e51716 %T Assessing the Short-Term Efficacy of Digital Cognitive Behavioral Therapy for Insomnia With Different Types of Coaching: Randomized Controlled Comparative Trial %A Chan,Wai Sze %A Cheng,Wing Yee %A Lok,Samson Hoi Chun %A Cheah,Amanda Kah Mun %A Lee,Anna Kai Win %A Ng,Albe Sin Ying %A Kowatsch,Tobias %+ Department of Psychology, The University of Hong Kong, Room 627, the Jockey Club Tower, Pokfulam, Hong Kong, Hong Kong, China (Hong Kong), 852 39172295, chanwais@hku.hk %K insomnia %K cognitive behavioral therapy %K digital intervention %K mobile health %K mHealth %K chatbot-based coaching %K human support %K mobile phone %D 2024 %7 7.8.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Digital cognitive behavioral therapy for insomnia (dCBTi) is an effective intervention for treating insomnia. The findings regarding its efficacy compared to face-to-face cognitive behavioral therapy for insomnia are inconclusive but suggest that dCBTi might be inferior. The lack of human support and low treatment adherence are believed to be barriers to dCBTi achieving its optimal efficacy. However, there has yet to be a direct comparative trial of dCBTi with different types of coaching support. Objective: This study examines whether adding chatbot-based and human coaching would improve the treatment efficacy of, and adherence to, dCBTi. Methods: Overall, 129 participants (n=98, 76% women; age: mean 34.09, SD 12.05 y) whose scores on the Insomnia Severity Index [ISI] were greater than 9 were recruited. A randomized controlled comparative trial with 5 arms was conducted: dCBTi with chatbot-based coaching and therapist support (dCBTi-therapist), dCBTi with chatbot-based coaching and research assistant support, dCBTi with chatbot-based coaching only, dCBTi without any coaching, and digital sleep hygiene and self-monitoring control. Participants were blinded to the condition assignment and study hypotheses, and the outcomes were self-assessed using questionnaires administered on the web. The outcomes included measures of insomnia (the ISI and the Sleep Condition Indicator), mood disturbances, fatigue, daytime sleepiness, quality of life, dysfunctional beliefs about sleep, and sleep-related safety behaviors administered at baseline, after treatment, and at 4-week follow-up. Treatment adherence was measured by the completion of video sessions and sleep diaries. An intention-to-treat analysis was conducted. Results: Significant condition-by-time interaction effects showed that dCBTi recipients, regardless of having any coaching, had greater improvements in insomnia measured by the Sleep Condition Indicator (P=.003; d=0.45) but not the ISI (P=.86; d=–0.28), depressive symptoms (P<.001; d=–0.62), anxiety (P=.01; d=–0.40), fatigue (P=.02; d=–0.35), dysfunctional beliefs about sleep (P<.001; d=–0.53), and safety behaviors related to sleep (P=.001; d=–0.50) than those who received digital sleep hygiene and self-monitoring control. The addition of chatbot-based coaching and human support did not improve treatment efficacy. However, adding human support promoted greater reductions in fatigue (P=.03; d=–0.33) and sleep-related safety behaviors (P=.05; d=–0.30) than dCBTi with chatbot-based coaching only at 4-week follow-up. dCBTi-therapist had the highest video and diary completion rates compared to other conditions (video: 16/25, 60% in dCBTi-therapist vs <3/21, <25% in dCBTi without any coaching), indicating greater treatment adherence. Conclusions: Our findings support the efficacy of dCBTi in treating insomnia, reducing thoughts and behaviors that perpetuate insomnia, reducing mood disturbances and fatigue, and improving quality of life. Adding chatbot-based coaching and human support did not significantly improve the efficacy of dCBTi after treatment. However, adding human support had incremental benefits on reducing fatigue and behaviors that could perpetuate insomnia, and hence may improve long-term efficacy. Trial Registration: ClinicalTrials.gov NCT05136638; https://www.clinicaltrials.gov/study/NCT05136638 %M 39110971 %R 10.2196/51716 %U https://mental.jmir.org/2024/1/e51716 %U https://doi.org/10.2196/51716 %U http://www.ncbi.nlm.nih.gov/pubmed/39110971 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e48284 %T Effects of Intervention Timing on Health-Related Fake News: Simulation Study %A Gwon,Nahyun %A Jeong,Wonjeong %A Kim,Jee Hyun %A Oh,Kyoung Hee %A Jun,Jae Kwan %+ Cancer Knowledge and Information Center, National Cancer Control Institute, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang, 10408, Republic of Korea, 82 31 920 2184, jkjun@ncc.re.kr %K disinformation %K fenbendazole %K cancer information %K simulation %K fake news %K online social networking %K misinformation %K lung cancer %D 2024 %7 7.8.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Fake health-related news has spread rapidly through the internet, causing harm to individuals and society. Despite interventions, a fenbendazole scandal recently spread among patients with lung cancer in South Korea. It is crucial to intervene appropriately to prevent the spread of fake news. Objective: This study investigated the appropriate timing of interventions to minimize the side effects of fake news. Methods: A simulation was conducted using the susceptible-infected-recovered (SIR) model, which is a representative model of the virus spread mechanism. We applied this model to the fake news spread mechanism. The parameters were set similarly to those in the digital environment, where the fenbendazole scandal occurred. NetLogo, an agent-based model, was used as the analytical tool. Results: Fake news lasted 278 days in the absence of interventions. As a result of adjusting and analyzing the timing of the intervention in response to the fenbendazole scandal, we found that faster intervention leads to a shorter duration of fake news (intervention at 54 days = fake news that lasted for 210 days; intervention at 16 days = fake news that lasted for 187 days; and intervention at 10 days = fake news that lasted for 157 days). However, no significant differences were observed when the intervention was performed within 10 days. Conclusions: Interventions implemented within 10 days were effective in reducing the duration of the spread of fake news. Our findings suggest that timely intervention is critical for preventing the spread of fake news in the digital environment. Additionally, a monitoring system that can detect fake news should be developed for a rapid response %M 39109788 %R 10.2196/48284 %U https://formative.jmir.org/2024/1/e48284 %U https://doi.org/10.2196/48284 %U http://www.ncbi.nlm.nih.gov/pubmed/39109788 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53134 %T Effectiveness and User Experience of a Smoking Cessation Chatbot: Mixed Methods Study Comparing Motivational Interviewing and Confrontational Counseling %A He,Linwei %A Basar,Erkan %A Krahmer,Emiel %A Wiers,Reinout %A Antheunis,Marjolijn %+ Department of Communication and Cognition, Tilburg School of Humanities and Digital Sciences, Tilburg University, Dante Building, D407, Warandelaan 2, Tilburg, 5037AB, Netherlands, 31 644911989, l.he_1@tilburguniversity.edu %K chatbot %K smoking cessation %K counseling %K motivational interviewing %K confrontational counseling %K user experience %K engagement %D 2024 %7 6.8.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Cigarette smoking poses a major public health risk. Chatbots may serve as an accessible and useful tool to promote cessation due to their high accessibility and potential in facilitating long-term personalized interactions. To increase effectiveness and acceptability, there remains a need to identify and evaluate counseling strategies for these chatbots, an aspect that has not been comprehensively addressed in previous research. Objective: This study aims to identify effective counseling strategies for such chatbots to support smoking cessation. In addition, we sought to gain insights into smokers’ expectations of and experiences with the chatbot. Methods: This mixed methods study incorporated a web-based experiment and semistructured interviews. Smokers (N=229) interacted with either a motivational interviewing (MI)–style (n=112, 48.9%) or a confrontational counseling–style (n=117, 51.1%) chatbot. Both cessation-related (ie, intention to quit and self-efficacy) and user experience–related outcomes (ie, engagement, therapeutic alliance, perceived empathy, and interaction satisfaction) were assessed. Semistructured interviews were conducted with 16 participants, 8 (50%) from each condition, and data were analyzed using thematic analysis. Results: Results from a multivariate ANOVA showed that participants had a significantly higher overall rating for the MI (vs confrontational counseling) chatbot. Follow-up discriminant analysis revealed that the better perception of the MI chatbot was mostly explained by the user experience–related outcomes, with cessation-related outcomes playing a lesser role. Exploratory analyses indicated that smokers in both conditions reported increased intention to quit and self-efficacy after the chatbot interaction. Interview findings illustrated several constructs (eg, affective attitude and engagement) explaining people’s previous expectations and timely and retrospective experience with the chatbot. Conclusions: The results confirmed that chatbots are a promising tool in motivating smoking cessation and the use of MI can improve user experience. We did not find extra support for MI to motivate cessation and have discussed possible reasons. Smokers expressed both relational and instrumental needs in the quitting process. Implications for future research and practice are discussed. %M 39106097 %R 10.2196/53134 %U https://www.jmir.org/2024/1/e53134 %U https://doi.org/10.2196/53134 %U http://www.ncbi.nlm.nih.gov/pubmed/39106097 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e57058 %T Analysis of Demographic and Socioeconomic Factors Influencing Adherence to a Web-Based Intervention Among Patients After Acute Coronary Syndrome: Prospective Observational Cohort Study %A Sassone,Biagio %A Fuca',Giuseppe %A Pedaci,Mario %A Lugli,Roberta %A Bertagnin,Enrico %A Virzi',Santo %A Bovina,Manuela %A Pasanisi,Giovanni %A Mandini,Simona %A Myers,Jonathan %A Tolomeo,Paolo %+ Division of Provincial Cardiology, Department of Translational Medicine, University of Ferrara, Via Savonarola, 9, Ferrara, 44121, Italy, 39 0516838219, biagio.sassone@unife.it %K telemedicine %K digital literacy %K digital health %K acute coronary syndrome %K older age %K caregiver %K socioeconomic %K educational %K mobile phone %D 2024 %7 2.8.2024 %9 Original Paper %J JMIR Cardio %G English %X Background: Although telemedicine has been proven to have significant potential for improving care for patients with cardiac problems, there remains a substantial risk of introducing disparities linked to the use of digital technology, especially for older or socially vulnerable subgroups. Objective: We investigated factors influencing adherence to a telemedicine-delivered health education intervention in patients with ischemia, emphasizing demographic and socioeconomic considerations. Methods: We conducted a descriptive, observational, prospective cohort study in consecutive patients referred to our cardiology center for acute coronary syndrome, from February 2022 to January 2023. Patients were invited to join a web-based health educational meeting (WHEM) after hospital discharge, as part of a secondary prevention program. The WHEM sessions were scheduled monthly and used a teleconference software program for remote synchronous videoconferencing, accessible through a standard computer, tablet, or smartphone based on patient preference or availability. Results: Out of the 252 patients (median age 70, IQR 61.0-77.3 years; n=189, 75% male), 98 (38.8%) declined the invitation to participate in the WHEM. The reasons for nonacceptance were mainly challenges in handling digital technology (70/98, 71.4%), followed by a lack of confidence in telemedicine as an integrative tool for managing their medical condition (45/98, 45.9%), and a lack of internet-connected devices (43/98, 43.8%). Out of the 154 patients who agreed to participate in the WHEM, 40 (25.9%) were unable to attend. Univariable logistic regression analysis showed that the presence of a caregiver with digital proficiency and a higher education level was associated with an increased likelihood of attendance to the WHEM, while the converse was true for increasing age and female sex. After multivariable adjustment, higher education level (odds ratio [OR] 2.26, 95% CI 1.53-3.32; P<.001) and caregiver with digital proficiency (OR 12.83, 95% CI 5.93-27.75; P<.001) remained independently associated with the outcome. The model discrimination was good even when corrected for optimism (optimism-corrected C-index=0.812), as was the agreement between observed and predicted probability of participation (optimism-corrected calibration intercept=0.010 and slope=0.948). Conclusions: This study identifies a notable lack of suitability for a specific cohort of patients with ischemia to participate in our telemedicine intervention, emphasizing the risk of digital marginalization for a significant portion of the population. Addressing low digital literacy rates among patients or their informal caregivers and overcoming cultural bias against remote care were identified as critical issues in our study findings to facilitate the broader adoption of telemedicine as an inclusive tool in health care. %M 38912920 %R 10.2196/57058 %U https://cardio.jmir.org/2024/1/e57058 %U https://doi.org/10.2196/57058 %U http://www.ncbi.nlm.nih.gov/pubmed/38912920 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e57577 %T Behavior Change Techniques Within Digital Interventions for the Treatment of Eating Disorders: Systematic Review and Meta-Analysis %A Thomas,Pamela Carien %A Curtis,Kristina %A Potts,Henry W W %A Bark,Pippa %A Perowne,Rachel %A Rookes,Tasmin %A Rowe,Sarah %+ Department of Epidemiology & Applied Clinical Research, Division of Psychiatry, University College London, 6th Floor, Wings A and B, Maple House, 149 Tottenham Court Road, London, W1T 7NF, United Kingdom, 44 0207 679 9000, s.rowe@ucl.ac.uk %K digital health %K eHealth %K mobile health %K mHealth %K mobile apps %K smartphone %K behavior change %K behavior change technique %K systematic review %K eating disorders %K disordered eating %K binge eating %K bulimia nervosa %K mobile phone %D 2024 %7 1.8.2024 %9 Review %J JMIR Ment Health %G English %X Background: Previous systematic reviews of digital eating disorder interventions have demonstrated effectiveness at improving symptoms of eating disorders; however, our understanding of how these interventions work and what contributes to their effectiveness is limited. Understanding the behavior change techniques (BCTs) that are most commonly included within effective interventions may provide valuable information for researchers and developers. Establishing whether these techniques have been informed by theory will identify whether they target those mechanisms of action that have been identified as core to changing eating disorder behaviors. It will also evaluate the importance of a theoretical approach to digital intervention design. Objective: This study aims to define the BCTs within digital self-management interventions or minimally guided self-help interventions for adults with eating disorders that have been evaluated within randomized controlled trials. It also assessed which of the digital interventions were grounded in theory and the range of modes of delivery included. Methods: A literature search identified randomized controlled trials of digital intervention for the treatment of adults with eating disorders with minimal therapist support. Each digital intervention was coded for BCTs using the established BCT Taxonomy v1; for the application of theory using an adapted version of the theory coding scheme (TCS); and for modes of delivery using the Mode of Delivery Ontology. A meta-analysis evaluated the evidence that any individual BCT moderated effect size or that other potential factors such as the application of theory or number of modes of delivery had an effect on eating disorder outcomes. Results: Digital interventions included an average of 14 (SD 2.6; range 9-18) BCTs. Self-monitoring of behavior was included in all effective interventions, with Problem-solving, Information about antecedents, Feedback on behavior, Self-monitoring of outcomes of behavior, and Action planning identified in >75% (13/17) of effective interventions. Social support and Information about health consequences were more evident in effective interventions at follow-up compared with postintervention measurement. The mean number of modes of delivery was 4 (SD 1.6; range 2-7) out of 12 possible modes, with most interventions (15/17, 88%) being web based. Digital interventions that had a higher score on the TCS had a greater effect size than those with a lower TCS score (subgroup differences: χ21=9.7; P=.002; I²=89.7%) within the meta-analysis. No other subgroup analyses had statistically significant results. Conclusions: There was a high level of consistency in terms of the most common BCTs within effective interventions; however, there was no evidence that any specific BCT contributed to intervention efficacy. The interventions that were more strongly informed by theory demonstrated greater improvements in eating disorder outcomes compared to waitlist or treatment-as-usual controls. These results can be used to inform the development of future digital eating disorder interventions. Trial Registration: PROSPERO CRD42023410060; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=410060 %M 39088817 %R 10.2196/57577 %U https://mental.jmir.org/2024/1/e57577 %U https://doi.org/10.2196/57577 %U http://www.ncbi.nlm.nih.gov/pubmed/39088817 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e50355 %T 5G Key Technologies for Helicopter Aviation Medical Rescue %A Han Sr,Wei %A Li 2nd,Yuanting %A Chen 3rd,Changgen %A Huang,Danni %A Wang,Junchao %A Li,Xiang %A Ji,Zhongliang %A Li,Qin %A Li,Zhuang %+ Emergency Department, Shenzhen University General Hospital, 1098 Xueyuan Avenue, Nanshan District, Shenzhen, 518055, China, 86 18813980300, sugh_hanwei@szu.edu.cn %K low airspace %K helicopters %K medical aid %K 5G technology %K aeronautical engineering %D 2024 %7 1.8.2024 %9 Viewpoint %J J Med Internet Res %G English %X Rapid global population growth and urbanization have heightened the demand for emergency medical rescue, with helicopter medical rescue emerging as an effective solution. The advent of 5G communication technology, characterized by large bandwidth, low latency, and high reliability, offers substantial promise in enhancing the efficiency and quality of helicopter rescue operations. However, the full integration of 5G technology into helicopter emergency medical services is still in its nascent stages and requires further development. In this viewpoint, we present our experience from the Shenzhen University General Hospital of the application of 5G low-altitude network communication technology, body area network disease sensing technology, and 5G air-ground collaborative rapid diagnosis and treatment technology in aeromedical rescue. We consider that the 5G air-to-ground collaborative rapid diagnosis and treatment technology enables high-quality remote consultation, enhancing emergency medical rescue and providing strong support for future rescue operations. %M 39088814 %R 10.2196/50355 %U https://www.jmir.org/2024/1/e50355 %U https://doi.org/10.2196/50355 %U http://www.ncbi.nlm.nih.gov/pubmed/39088814 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56827 %T Smartphone-Based Smoking Cessation Intervention (OKquit) for Oklahoma Tobacco Helpline Users: Protocol for a Randomized Controlled Trial %A Businelle,Michael %A Becerra,Jessica %A Witten,Carl %A Chen,Sixia %A Kezbers,Krista %A Beebe,Laura A %A Kendzor,Darla E %+ TSET Health Promotion Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, 655 Research Parkway, Suite 400, Oklahoma City, OK, 73104, United States, 1 4052718001 ext 50460, michael-businelle@ouhsc.edu %K smoking cessation %K helpline %K just-in-time adaptive intervention %K mobile application %K smartphone-based %K mobile health %K tobacco %D 2024 %7 1.8.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Tobacco quitlines provide effective resources (eg, nicotine replacement therapy, smoking cessation counseling, and text and web-based support) for those who want to quit smoking in the United States. However, quitlines reach approximately only 1%-3% of people who smoke each year. Novel, smartphone-based, and low-burden interventions that offer 24/7 access to smoking cessation resources that are tailored to current readiness to quit may increase appeal, reach, and effectiveness of smoking cessation interventions. Objective: This study will examine the efficacy of OKquit, a low-burden smartphone-based app for smoking cessation. Methods: Approximately 500 people who smoke cigarettes and access the Oklahoma Tobacco Helpline (OTH) will be randomized to receive standard OTH care (SC) or SC plus the novel OKquit smartphone app for smoking cessation (OKquit). All participants will use a smartphone app to complete study surveys (ie, baseline, 27 weekly surveys, brief daily check-ins, and 27-week follow-up). Upon completion of daily check-ins and weekly surveys, participants will receive either trivia type messages (SC) or messages that are tailored to current readiness to quit smoking and currently experienced lapse triggers (OKquit). In addition, those assigned to receive the OKquit app will have access to on-demand smoking cessation content (eg, quit tips, smoking cessation medication tips). It is hypothesized that participants assigned to OKquit will be more likely to achieve biochemically verified 7-day point prevalence abstinence than those assigned to SC at 27 weeks post enrollment. In addition, participants who use more OTH resources (eg, more cessation coaching sessions completed) or more OKquit resources (eg, access more quit tips) will have greater biochemically verified smoking cessation rates. Results: Data collection began in September 2022 and final follow-ups are expected to be completed by May 2025. Conclusions: Data from this randomized controlled trial will determine whether the OKquit smartphone app combined with OTH care will increase smoking cessation rates over standard OTH care alone. If successful, OKquit could provide tailored intervention content at a fraction of the cost of traditional interventions. Furthermore, this type of low-burden intervention may offer a way to reach underserved populations of adults who smoke and want to quit. Trial Registration: ClinicalTrials.gov NCT05539209; https://clinicaltrials.gov/study/NCT05539209 International Registered Report Identifier (IRRID): DERR1-10.2196/56827 %M 39088254 %R 10.2196/56827 %U https://www.researchprotocols.org/2024/1/e56827 %U https://doi.org/10.2196/56827 %U http://www.ncbi.nlm.nih.gov/pubmed/39088254 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e58174 %T Assessing the Effectiveness of eHealth Interventions to Manage Multiple Lifestyle Risk Behaviors Among Older Adults: Systematic Review and Meta-Analysis %A Shi,Beibei %A Li,Guangkai %A Wu,Shuang %A Ge,Hongli %A Zhang,Xianliang %A Chen,Si %A Pan,Yang %A He,Qiang %+ School of Physical Education, Shandong University, 17922 Jingshi Road, Lixia District, Shandong Province, Jinan, 250061, China, 86 0531 88395374, hq@sdu.edu.cn %K eHealth %K lifestyle risk behaviors %K older adults %K multiple health behavior change %K mobile phone %D 2024 %7 31.7.2024 %9 Review %J J Med Internet Res %G English %X Background: Developing adverse lifestyle behaviors increases the risk of a variety of chronic age-related diseases, including cardiovascular disease, obesity, and Alzheimer disease. There is limited evidence regarding the effectiveness of eHealth-based multiple health behavior change (MHBC) interventions to manage lifestyle risk behaviors. Objective: The purpose of this systematic evaluation was to assess the effectiveness of eHealth MHBC interventions in changing ≥2 major lifestyle risk behaviors in people aged ≥50 years. Methods: The literature search was conducted in 6 electronic databases—PubMed, Embase, Web of Science, Scopus, Cochrane Library, and SPORTDiscus—from inception to May 1, 2024. Eligible studies were randomized controlled trials of eHealth interventions targeting ≥2 of 6 behaviors of interest: alcohol use, smoking, diet, physical activity (PA), sedentary behavior, and sleep. Results: A total of 34 articles with 35 studies were included. eHealth-based MHBC interventions significantly increased smoking cessation rates (odds ratio 2.09, 95% CI 1.62-2.70; P<.001), fruit intake (standardized mean difference [SMD] 0.18, 95% CI 0.04-0.32; P=.01), vegetable intake (SMD 0.17, 95% CI 0.05-0.28; P=.003), self-reported total PA (SMD 0.22, 95% CI 0.02-0.43; P=.03), and objectively measured moderate to vigorous PA (SMD 0.25, 95% CI 0.09-0.41; P=.002); in addition, the interventions decreased fat intake (SMD –0.23, 95% CI –0.33 to –0.13; P<.001). No effects were observed for alcohol use, sedentary behavior, or sleep. A sensitivity analysis was conducted to test the robustness of the pooled results. Moreover, the certainty of evidence was evaluated using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) framework. Conclusions: eHealth-based MHBC interventions may be a promising strategy to increase PA, improve diet, and reduce smoking among older adults. However, the effect sizes were small. Further high-quality, older adult–oriented research is needed to develop eHealth interventions that can change multiple behaviors. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42023444418; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023444418 %M 39083787 %R 10.2196/58174 %U https://www.jmir.org/2024/1/e58174 %U https://doi.org/10.2196/58174 %U http://www.ncbi.nlm.nih.gov/pubmed/39083787 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e57777 %T Sustainable Lifestyle Among Office Workers (the SOFIA Study): Protocol for a Cluster Randomized Controlled Trial %A Bälter,Katarina %A King,Abby C %A Fritz,Johanna %A Tillander,Annika %A Halling Ullberg,Oskar %+ Division of Public Health, School of Health, Care and Social Welfare, Mälardalen University, Universitetsplan 1, Västerås, 721 23, Sweden, 46 0736620898, katarina.balter@mdu.se %K diet %K physical activity %K work life %K health promotion %K climate change %K sustainable lifestyle %K citizen science %K Our Voice %D 2024 %7 31.7.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Society is facing multiple challenges, including lifestyle- and age-related diseases of major public health relevance, and this is of particular importance when the general population, as well as the workforce, is getting older. In addition, we are facing global climate change due to extensive emissions of greenhouse gases and negative environmental effects. A lifestyle that promotes healthy life choices as well as climate and environmentally friendly decisions is considered a sustainable lifestyle. Objective: This study aims to evaluate if providing information about a sustainable lifestyle encourages individuals to adopt more nutritious dietary habits and increase physical activity, as compared to receiving information solely centered around health-related recommendations for dietary intake and physical activity by the Nordic Nutrition Recommendations and the World Health Organization. Novel features of this study include the use of the workplace as an arena for health promotion, particularly among office workers—a group known to be often sedentary at work and making up 60% of all employees in Sweden. Methods: The Sustainable Office Intervention (SOFIA) study is a 2-arm, participant-blinded, cluster randomized controlled trial that includes a multilevel sustainable lifestyle arm (intervention arm, n=19) and a healthy lifestyle arm (control arm, n=14). The eligibility criteria were being aged 18-65 years and doing office work ≥20 hours per week. Both intervention arms are embedded in the theoretically based behavioral change wheel method. The intervention study runs for approximately 8 weeks and contains 6 workshops. The study focuses on individual behavior change as well as environmental and policy features at an organizational level to facilitate or hinder a sustainable lifestyle at work. Through implementing a citizen science methodology within the trial, the participants (citizen scientists) collect data using the Stanford Our Voice Discovery Tool app and are involved in analyzing the data, formulating a list of potential actions to bring about feasible changes in the workplace. Results: Participant recruitment and data collection began in August 2022. As of June 2024, a total of 37 participants have been recruited. The results of the pilot phase are expected to be published in 2024 or 2025. Conclusions: Given the ongoing climate change, negative environmental effects, and the global epidemic of metabolic diseases, a sustainable lifestyle among office workers holds important potential to help in counteracting this trend. Thus, there is an urgent unmet need to test the impact of a sustainable lifestyle on food intake, physical activity, and environmental and climate impacts in a worksite-based randomized controlled trial. This study protocol responds to a societal need by addressing multilevel aspects, including individual behavior changes as well as environmental and organizational changes of importance for the successful implementation of sustainable lifestyle habits in an office setting. International Registered Report Identifier (IRRID): DERR1-10.2196/57777 %M 39083333 %R 10.2196/57777 %U https://www.researchprotocols.org/2024/1/e57777 %U https://doi.org/10.2196/57777 %U http://www.ncbi.nlm.nih.gov/pubmed/39083333 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e56758 %T Acceptability and Engagement of a Smartphone-Delivered Interpretation Bias Intervention in a Sample of Black and Latinx Adults: Open Trial %A Ferguson,IreLee %A George,Grace %A Narine,Kevin O %A Turner,Amari %A McGhee,Zelda %A Bajwa,Harris %A Hart,Frances G %A Carter,Sierra %A Beard,Courtney %+ Department of Psychiatry, McLean Hospital/Harvard Medical School, 115 Mill St, Belmont, MA, 02478, United States, 1 617 855 3557, cbeard@mclean.harvard.edu %K interpretation bias %K anxiety %K depression %K Black %K Latinx %K smartphone %K mobile phone %D 2024 %7 31.7.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Access to evidence-based interventions is urgently required, especially for individuals of minoritized identities who experience unique barriers to mental health care. Digital mental health interventions have the potential to increase accessibility. Previous pilot studies testing HabitWorks, a smartphone app providing an interpretation bias intervention, have found strong engagement and adherence for HabitWorks; however, previous trials’ samples consisted of predominantly non-Hispanic, White individuals. Objective: This study conducted an open trial of HabitWorks in a community sample of adults who identified as Black, Hispanic or Latinx, or both. This study aims to test safety, acceptability, and engagement with the HabitWorks app for Black and Latinx adults. Methods: Black, Hispanic or Latinx adults (mean age 32.83, SD 11.06 y; 22/31, 71% women) who endorsed symptoms of anxiety or depression were asked to complete interpretation modification exercises via HabitWorks 3 times per week for 1 month. Interpretation bias and anxiety and depression symptoms were assessed at baseline and posttreatment assessments. Participants completed qualitative interviews to assess overall perceptions of HabitWorks. Results: Of the 31 participants that downloaded the app, 27 (87%) used HabitWorks all 4 weeks. On average, participants completed 15.74 (SD 7.43) exercises out of the 12 prescribed, demonstrating high engagement. Acceptability ratings met all a priori benchmarks except for relevancy. Qualitative interviews also demonstrated high acceptability and few negative experiences. Significant improvements were found in interpretation style (t30=2.29; P<.001), with a large effect size (Cohen d=1.53); anxiety symptoms (t30=2.29; P=.03), with a small effect size (Cohen d=0.41); and depression symptoms (t30=3.065; P=.005), with a medium effect size (Cohen d=0.55). Conclusions: This study adds to the literature evaluating digital mental health interventions in Black and Latinx adults. Preliminary results further support a future controlled trial testing the effectiveness of HabitWorks as an intervention. %M 39083330 %R 10.2196/56758 %U https://mental.jmir.org/2024/1/e56758 %U https://doi.org/10.2196/56758 %U http://www.ncbi.nlm.nih.gov/pubmed/39083330 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e54723 %T Impact of a Health Coach–Led, Text-Based Digital Behavior Change Intervention on Weight Loss and Psychological Well-Being in Patients Receiving a Procedureless Intragastric Balloon Program: Prospective Single-Arm Study %A Sacher,Paul M %A Fulton,Emily %A Rogers,Victoria %A Wilson,Julia %A Gramatica,Marco %A Dent,Jennifer E %A Aarts,Edo O %A Eccleston,David %A Greve,Jan Willem %A Palm-Meinders,Inge %A Chuttani,Ram %+ Allurion Technologies Inc, 11 Huron Dr, Natick, MA, 01760, United States, 1 508 647 4000, psacher@icloud.com %K intragastric balloon %K obesity %K behavior change %K health coaching %K digital health %K weight management %K well-being %K mobile phone %D 2024 %7 31.7.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital health interventions show promise for weight management. However, few text-based behavior change interventions have been designed to support patients receiving intragastric balloons, and none have simultaneously evaluated weight loss, psychological well-being, and behavior change despite the crucial interplay of these factors in weight management. Objective: This study aims to assess whether a health coach–led, asynchronous, text-based digital behavior change coaching intervention (DBCCI) delivered to participants receiving an intragastric balloon and its aftercare program was feasible and acceptable to participants and supported improved outcomes, including weight loss, psychological well-being, and lifestyle behavior change conducive to weight loss maintenance. Methods: This 12-month, single-arm prospective study enrolled adults aged 21 to 65 years with BMI ≥27 kg/m2 receiving a procedureless intragastric balloon (PIGB) at 5 bariatric clinics in the United Kingdom and the Netherlands. Participants received the DBCCI and the clinic-led PIGB aftercare program (remotely delivered) for 6 months after PIGB placement and then no intervention for an additional 6 months. The DBCCI was an evidence-based, personalized intervention wherein health coaches supported participants via exchanged asynchronous in-app text-based messages. Over the 12-month study, we assessed percentage of total body weight loss and psychological well-being via self-administered validated questionnaires (Warwick-Edinburgh Mental Wellbeing Scale, Generalized Anxiety Disorder Scale, Impact of Weight on Quality of Life–Lite–Clinical Trials Version, Loss of Control Over Eating Scale–Brief, Weight Efficacy Lifestyle Questionnaire–Short Form, and Barriers to Being Active Quiz). Participant engagement with and acceptability of the intervention were assessed via self-reported surveys. Results: Overall, 107 participants (n=96, 89.7% female; mean baseline BMI 35.4, SD 5.4 kg/m2) were included in the analysis. Mean total body weight loss was 13.5% (SEM 2.3%) at the end of the DBCCI and 11.22% (SEM 2.3%) at the 12-month follow-up (P<.001). Improvements were observed for all psychological well-being measures throughout the 12 months except for the Generalized Anxiety Disorder Scale (improvement at month 1) and Barriers to Being Active Quiz (improvements at months 3 and 6). Surveys showed high levels of engagement with and acceptability of the DBCCI. Conclusions: This study provides evidence that the health coach–led, asynchronous, text-based DBCCI was engaging and acceptable to participants with overweight and obesity. The DBCCI, delivered alongside the PIGB and its aftercare program, supported improved weight loss outcomes and psychological well-being versus baseline and was associated with lifestyle behavior changes known to help achieve and maintain long-term weight loss and improved health outcomes. Follow-up findings suggest a potential need for longer-term, more intense coaching to focus on weight loss maintenance and support ongoing self-coaching. This could be achieved by leveraging generative artificial intelligence to provide ongoing automated behavior change coaching support to augment human-led care. Trial Registration: ClinicalTrials.gov NCT05884606; https://clinicaltrials.gov/study/NCT05884606 %M 39083340 %R 10.2196/54723 %U https://formative.jmir.org/2024/1/e54723 %U https://doi.org/10.2196/54723 %U http://www.ncbi.nlm.nih.gov/pubmed/39083340 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e51206 %T Physical Activity, Body Composition, and Fitness Variables in Adolescents After Periods of Mandatory, Promoted or Nonmandatory, Nonpromoted Use of Step Tracker Mobile Apps: Randomized Controlled Trial %A Mateo-Orcajada,Adrián %A Vaquero-Cristóbal,Raquel %A Mota,Jorge %A Abenza-Cano,Lucía %+ Research Group Movement Sciences and Sport (MS&SPORT), Department of Physical Activity and Sport, Faculty of Sport Sciences, University of Murcia, C. Argentina 19, San Javier, Murcia, 30720, Spain, 34 868 88 86 84, raquel.vaquero@um.es %K body composition %K detraining %K new technologies %K physical education subject %K physical fitness %K youth %D 2024 %7 30.7.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: It is not known whether an intervention made mandatory as a physical education (PE) class assignment and aimed at promoting physical activity (PA) in adolescents can create a healthy walking habit, which would allow further improvements to be achieved after the mandatory and promoted intervention has been completed. Objective: The aims of this study were to (1) investigate whether, after a period of using a step tracker mobile app made mandatory and promoted as a PE class assignment, adolescents continue to use it when its use is no longer mandatory and promoted; (2) determine whether there are changes in the PA level, body composition, and fitness of adolescents when the use of the app is mandatory and promoted and when it is neither mandatory nor promoted; and (3) analyze whether the covariates maturity status, gender, and specific app used can have an influence. Methods: A total of 357 students in compulsory secondary education (age: mean 13.92, SD 1.91 y) participated in the study. A randomized controlled trial was conducted consisting of 2 consecutive 10-week interventions. Participants’ PA level, body composition, and fitness were measured at baseline (T1), after 10 weeks of mandatory and promoted app use (T2), and after 10 weeks of nonmandatory and nonpromoted app use (T3). Each participant in the experimental group (EG) used 1 of 4 selected step tracker mobile apps after school hours. Results: The results showed that when the use of the apps was neither mandatory nor promoted as a PE class assignment, only a few adolescents (18/216, 8.3%) continued the walking practice. After the mandatory and promoted intervention period (T1 vs T2), a decrease in the sum of 3 skinfolds (mean difference [MD] 1.679; P=.02) as well as improvements in the PA level (MD –0.170; P<.001), maximal oxygen uptake (MD –1.006; P<.001), countermovement jump test (MD –1.337; P=.04), curl-up test (MD –3.791; P<.001), and push-up test (MD –1.920; P<.001) in the EG were recorded. However, the changes between T1 and T2 were significantly greater in the EG than in the control group only in the PA level and curl-up test. Thus, when comparing the measurements taken between T1 and T3, no significant changes in body composition (P=.07) or fitness (P=.84) were observed between the EG and the control group. The covariates maturity status, gender, and specific app used showed a significant effect in most of the analyses performed. Conclusions: A period of mandatory and promoted use of step tracker mobile apps benefited the variables of body composition and fitness in adolescents but did not create a healthy walking habit in this population; therefore, when the use of these apps ceased to be mandatory and promoted, the effects obtained disappeared. Trial Registration: ClinicalTrials.gov NCT06164041; https://clinicaltrials.gov/study/NCT06164041 %M 39079110 %R 10.2196/51206 %U https://mhealth.jmir.org/2024/1/e51206 %U https://doi.org/10.2196/51206 %U http://www.ncbi.nlm.nih.gov/pubmed/39079110 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e57950 %T Mobile App Promoting Resilience in Stress Management for Adolescents and Young Adults With Cancer: Protocol for a Pilot Randomized Controlled Trial %A Lau,Nancy %A Palermo,Tonya M %A Zhou,Chuan %A Badillo,Isabel %A Hong,Shannon %A Aalfs,Homer %A Yi-Frazier,Joyce P %A McCauley,Elizabeth %A Chow,Eric J %A Weiner,Bryan J %A Ben-Zeev,Dror %A Rosenberg,Abby R %+ Center for Child Health, Behavior and Development, Seattle Children’s Research Institute, 1920 Terry Ave, Seattle, WA, 98101, United States, 1 206 884 8238, nancy.lau@seattlechildrens.org %K adolescents %K young adult %K cancer %K mHealth %K psychosocial intervention %K stress management %K coping %K resilience %K health-related quality of life %K randomized controlled trial %K mobile phone %D 2024 %7 30.7.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adolescents and young adults (AYAs) with cancer are at risk of poor psychosocial outcomes. AYAs grew up with the internet and digital technology, and mobile Health (mHealth) psychosocial interventions have the potential to overcome care access barriers. Objective: This pilot randomized controlled trial (RCT) aimed to establish the feasibility, acceptability, and preliminary efficacy of a fully automated mobile app version of the Promoting Resilience in Stress Management intervention (mPRISM). Promoting Resilience in Stress Management is an evidence-based intervention developed in collaboration with AYAs, based on stress and coping theory, resilience theory, and evidence-based coping strategies. We hypothesized that mPRISM would be feasible, acceptable, and appropriate. Methods: This is a parallel, 2-arm, single-site pilot RCT with a waitlist control design. The study will recruit 80 AYAs with cancer from a clinic. Eligible AYAs are aged 12 to 25 years, within 12 months of a new cancer diagnosis, receiving chemotherapy or radiation therapy, speak, read, or write in English, and are cognitively able to participate in study procedures. Recruitment by clinical research coordinators will occur remotely by phone, video, or text. Participants will be randomized to psychosocial usual care (UC) alone or UC plus mPRISM for an 8-week intervention period, and will remain unblinded to study condition. Enrolled participants will complete surveys at baseline before randomization, 8 weeks, and 3-month follow-up. Using a waitlist design, the UC arm will receive mPRISM upon completion of 3-month follow-up surveys. Those in the UC arm will complete 2 additional measurement points at immediate posttreatment and 3 months later. The primary outcomes of interest are feasibility, defined as ≥60% enrollment and ≥70% retention (ie, percentage of participants who completed the study), and “feasibility, acceptability, and appropriateness” as defined by cut-off scores ≥4/5 on 3 brief validated implementation outcome measures (feasibility of implementation measure, acceptability of intervention measure [AIM], intervention appropriateness measure [IAM]). We will apply top-box scoring for the implementation measures. Exploratory outcomes of interest include patient-reported health-related quality of life, resilience, distress, anxiety, depression, pain, and sleep. We will conduct an intention-to-treat analysis to compare the outcomes of the mPRISM arm versus the control arm with covariate-adjusted regression models. We will summarize individual digital usage metrics using descriptive statistics. Results: Since September 2023, we have enrolled 20 participants and recruitment is ongoing. Conclusions: Although our previous work suggests AYAs with cancer are interested in mHealth psychosocial interventions, such interventions have not yet been sufficiently evaluated or implemented among AYA oncology patients. mPRISM may serve as a potential mHealth intervention to fill this gap. In this study, we will test the feasibility, acceptability, and preliminary efficacy of mPRISM. This work will inform future larger-scale RCTs powered for efficacy outcomes. Trial Registration: ClinicalTrials.gov NCT05842902; https://clinicaltrials.gov/study/NCT05842902 International Registered Report Identifier (IRRID): DERR1-10.2196/57950 %M 39079108 %R 10.2196/57950 %U https://www.researchprotocols.org/2024/1/e57950 %U https://doi.org/10.2196/57950 %U http://www.ncbi.nlm.nih.gov/pubmed/39079108 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e57694 %T Efficacy of Digital Dance on Brain Imagery, Cognition, and Health: Randomized Controlled Trial %A Tung,Heng-Hsin %A Kuo,Chen-Yuan %A Lee,Pei-Lin %A Chang,Chih-Wen %A Chou,Kun-Hsien %A Lin,Ching-Po %A Chen,Liang-Kung %+ Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, No.201, Sec. 2, Shipai Rd, Beitou District, Taipei, 11217, Taiwan, 886 2 2875 7808, lkchen2@vghtpe.gov.tw %K digital %K somatosensory dance %K somatosensory game %K cognitive performance %K physical function %K resilience %K demoralization %K quality of life %K dance %K dancer %K dancing %K movement %K sport %K sports %K cognitive %K cognition %K brain %K neuroscience %K image %K imagery %K imaging %K RCT %K randomized %K controlled trial %K controlled trials %K somatosensory %K gerontology %K geriatric %K geriatrics %K older adult %K older adults %K elder %K elderly %K older person %K older people %K ageing %K aging %K aged %K game %K games %K gaming %D 2024 %7 30.7.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Multidomain interventions have demonstrable benefits for promoting healthy aging, but self-empowerment strategies to sustain long-term gains remain elusive. Objective: This study evaluated the effects of digital somatosensory dance game participation on brain imagery changes as primary outcomes and other physical and mental health measures as secondary outcomes related to healthy aging. Methods: Between August 31, 2020, and June 27, 2021, this randomized controlled trial recruited 60 eligible participants older than 55 years with no recent engagement in digital dance games. A computer-generated randomization sequence was used to allocate participants 1:1, without stratification, to an intervention group (n=30) who underwent digital somatosensory dance game training or a control group (n=30). An anonymized code masked the intervention allocations from the investigators, and individuals who assigned the interventions were not involved in analyzing the study data. The intervention entailed two 30-minute dance game sessions per week for 6 months, and the control group received healthy aging education. Primary outcomes were brain imagery changes. All variables were measured at baseline and the 6-month follow-up, and intervention effects were estimated using t tests with intention-to-treat analyses. Results: Compared with the control group, intervention participants had significantly different brain imagery in the gray matter volume (GMV) of the left putamen (estimate 0.016, 95% CI 0.008 to 0.024; P<.001), GMV of the left pallidum (estimate 0.02, 95% CI 0.006 to 0.034; P=.004), and fractional amplitude of low frequency fluctuations of the left pallidum (estimate 0.262, 95% CI 0.084 to 0.439; P=.004). Additionally, the intervention group had different imagery in the cerebellum VI GMV (estimate 0.011, 95% CI 0.003 to 0.02; P=.01). The intervention group also had improved total Montreal Cognitive Assessment scores (estimate 1.2, 95% CI 0.27 to −2.13; P<.01), quality of life (estimate 7.08, 95% CI 2.35 to 11.82; P=.004), and time spent sitting on weekdays (estimate −1.96, 95% CI −3.33 to −0.60; P=.005). Furthermore, dance performance was significantly associated with cognitive performance (P=.003), health status (P=.14), resilience (P=.007), and demoralization (P<.001). Conclusions: Digital somatosensory dance game participation for 6 months was associated with brain imagery changes in multiple regions involving somatosensory, motor, visual, and attention functions, which were consistent with phenotypic improvements associated with healthy aging. Trial Registration: ClinicalTrials.gov NCT05411042; https://clinicaltrials.gov/study/NCT05411042 %M 39078687 %R 10.2196/57694 %U https://www.jmir.org/2024/1/e57694 %U https://doi.org/10.2196/57694 %U http://www.ncbi.nlm.nih.gov/pubmed/39078687 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 9 %N %P e51491 %T Development of a Novel Mobile Health App to Empower Young People With Type 1 Diabetes to Exercise Safely: Co-Design Approach %A Shetty,Vinutha B %A Fried,Leanne %A Roby,Heather C %A Soon,Wayne H K %A Nguyen,Rebecca %A Ong,Arthur %A Jaimangal,Mohinder %A Francis,Jacinta %A Paramalingam,Nirubasini %A Cross,Donna %A Davis,Elizabeth %+ Department of Endocrinology and Diabetes, Perth Children's Hospital, Telethon Kids Institute, University of Western Australia, Division of Paediatrics, Medical School, 15 Hospital Avenue, Nedlands, Perth City, 6009, Australia, 61 428325867, vinutha.shetty@health.wa.gov.au %K Mobile health application %K Exercise %K fitness %K physical activity %K design %K co-design %K focus group %K focus groups %K acT1ve %K Type 1 diabetes %K Young people %K Blood glucose level %K diabetic %K diabetes %K young %K youth %K type 1 %K prototype %K develop %K development %K mHealth %K mobile health %K app %K apps %K applications %K applications %K user-centered design %K mobile phone %D 2024 %7 30.7.2024 %9 Original Paper %J JMIR Diabetes %G English %X Background: Blood glucose management around exercise is challenging for youth with type 1 diabetes (T1D). Previous research has indicated interventions including decision-support aids to better support youth to effectively contextualize blood glucose results and take appropriate action to optimize glucose levels during and after exercise. Mobile health (mHealth) apps help deliver health behavior interventions to youth with T1D, given the use of technology for glucose monitoring, insulin dosing, and carbohydrate counting. Objective: We aimed to develop a novel prototype mHealth app to support exercise management among youth with T1D, detail the application of a co-design process and design thinking principles to inform app design and development, and identify app content and functionality that youth with T1D need to meet their physical activity goals. Methods: A co-design approach with a user-centered design thinking framework was used to develop a prototype mHealth app “acT1ve” during the 18-month design process (March 2018 to September 2019). To better understand and respond to the challenges among youth with diabetes when physically active, 10 focus groups were conducted with youth aged 13-25 years with T1D and parents of youth with T1D. Thereafter, we conducted participatory design workshops with youth to identify key app features that would support individual needs when physically active. These features were incorporated into a wireframe, which was critically reviewed by participants. A beta version of “acT1ve” was built in iOS and android operating systems, which underwent critical review by end users, clinicians, researchers, experts in exercise and T1D, and app designers. Results: Sixty youth with T1D, 14 parents, 6 researchers, and 10 clinicians were engaged in the development of “acT1ve.” acT1ve included key features identified by youth, which would support their individual needs when physically active. It provided advice on carbohydrates and insulin during exercise, information on hypoglycemia treatment, pre- and postexercise advice, and an educational food guide regarding exercise management. “acT1ve” contained an exercise advisor algorithm comprising 240 pathways developed by experts in diabetes and exercise research. Based on participant input during exercise, acT1ve provided personalized insulin and carbohydrate advice for exercise lasting up to 60 minutes. It also contains other features including an activity log, which displays a complete record of the end users’ activities and associated exercise advice provided by the app’s algorithm for later reference, and regular reminder notifications for end users to check or monitor their glucose levels. Conclusions: The co-design approach and the practical application of the user-centered design thinking framework were successfully applied in developing “acT1ve.” The design thinking processes allowed youth with T1D to identify app features that would support them to be physically active, and particularly enabled the delivery of individualized advice. Furthermore, app development has been described in detail to help guide others embarking on a similar project. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619001414101; https://tinyurl.com/mu9jvn2d %M 39078700 %R 10.2196/51491 %U https://diabetes.jmir.org/2024/1/e51491 %U https://doi.org/10.2196/51491 %U http://www.ncbi.nlm.nih.gov/pubmed/39078700 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e55366 %T eHealth-Integrated Psychosocial and Physical Interventions for Chronic Pain in Older Adults: Scoping Review %A De Lucia,Annalisa %A Perlini,Cinzia %A Chiarotto,Alessandro %A Pachera,Sara %A Pasini,Ilenia %A Del Piccolo,Lidia %A Donisi,Valeria %+ Section of Clinical Psychology, Department of Neuroscience, Biomedicine and Movement Sciences, University of Verona, Piazzale Ludovico Antonio Scuro 10, Verona, 37134, Italy, 39 0458124038, cinzia.perlini@univr.it %K chronic pain %K older adults %K eHealth %K scoping review %K psychological intervention %K physical intervention %K multimodal intervention %K biopsychosocial model for chronic pain %K self-management %K mobile phone %D 2024 %7 29.7.2024 %9 Review %J J Med Internet Res %G English %X Background: Chronic noncancer pain (CNCP) is highly present among older adults, affecting their physical, psychological, and social functioning. A biopsychosocial multimodal approach to CNCP management is currently extensively suggested by international clinical practice guidelines. Recently, the growing development and application of eHealth within pain management has yielded encouraging results in terms of effectiveness and feasibility; however, its use among the older population remains underexamined. Objective: The overall aim of this scoping review was to systematically map existing literature about eHealth multimodal interventions (including both physical and psychosocial components) targeting older adults with CNCP. Methods: This review adhered to the JBI methodology, a protocol was a priori registered as a preprint on the medRxiv platform, and the results were reported according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Four electronic databases (PubMed, Cochrane Central Register of Controlled Trials, Web of Science, and PsycINFO) were systematically searched for relevant articles. Studies were included if they reported on multimodal interventions (including both physical and psychosocial components) delivered through any eHealth modality to an older population with any type of CNCP. Two reviewers selected the studies: first by screening titles and abstracts and second by screening full-text articles. The quality of the included studies was evaluated using the Quality Assessment Tool for Studies with Diverse Designs. The results of the studies were summarized narratively. Results: A total of 9 studies (n=6, 67% published between 2021 and 2023) with quality rated as medium to high were included, of which 7 (78%) were randomized controlled trials (n=5, 71% were pilot and feasibility studies). All the included studies evaluated self-management interventions, most of them (n=7, 78%) specifically designed for older adults. The participants were aged between 65 and 75 years on average (mean 68.5, SD 3.5 y) and had been diagnosed with different types of CNCP (eg, osteoarthritis and chronic low back pain). Most of the included studies (5/9, 56%) involved the use of multiple eHealth modalities, with a higher use of web-based programs and video consulting. Only 1 (11%) of the 9 studies involved a virtual reality–based intervention. The evaluated interventions showed signs of effectiveness in the targeted biopsychosocial outcomes, and the participants’ engagement and ratings of satisfaction were generally positive. However, several research gaps were identified and discussed. Conclusions: Overall, of late, there has been a growing interest in the potential that eHealth multimodal interventions offer in terms of improving pain, physical, and psychosocial outcomes in older adults with CNCP. However, existing literature on this topic still seems scarce and highly heterogeneous, with few proper randomized controlled trials, precluding robust conclusions. Several gaps emerged in terms of the older population considered and the lack of evaluation of comorbidities. International Registered Report Identifier (IRRID): RR2-10.1101/2023.07.27.23293235 %M 39073865 %R 10.2196/55366 %U https://www.jmir.org/2024/1/e55366 %U https://doi.org/10.2196/55366 %U http://www.ncbi.nlm.nih.gov/pubmed/39073865 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e56504 %T Patterns of Ownership and Usage of Wearable Devices in the United States, 2020-2022: Survey Study %A Nagappan,Ashwini %A Krasniansky,Adriana %A Knowles,Madelyn %+ Department of Health Policy and Management, University of California, Los Angeles, 650 Charles E Young Dr S, 31-269 CHS, Los Angeles, CA, 90095, United States, 1 3108252594, ashwininagappan@ucla.edu %K digital health %K health equity %K adoption %K usage patterns %K wearable devices %K United States %K adoption %K technology %K sociodemographic %K survey %K health insurance %K public health %D 2024 %7 26.7.2024 %9 Short Paper %J J Med Internet Res %G English %X Background: Although wearable technology has become increasingly common, comprehensive studies examining its ownership across different sociodemographic groups are limited.  Objective: The aims of this study were to (1) measure wearable device ownership by sociodemographic characteristics in a cohort of US consumers and (2) investigate how these devices are acquired and used for health-related purposes. Methods: Data from the Rock Health Digital Health Consumer Adoption Survey collected from 2020 to 2022 with 23,974 US participants were analyzed. The sample was US Census–matched for demographics, including age, race/ethnicity, gender, and income. The relationship between sociodemographic factors and wearable ownership was explored using descriptive analysis and multivariate logistic regression. Results: Of the 23,974 respondents, 10,679 (44.5%) owned wearables. Ownership was higher among younger individuals, those with higher incomes and education levels, and respondents living in urban areas. Compared to those aged 18-24 years, respondents 65 years and older had significantly lower odds of wearable ownership (odds ratio [OR] 0.18, 95% CI 0.16-0.21). Higher annual income (≥US $200,000; OR 2.27, 95% CI 2.01-2.57) and advanced degrees (OR 2.23, 95% CI 2.01-2.48) were strong predictors of ownership. Living in rural areas reduced ownership odds (OR 0.65, 95% CI 0.60-0.72). There was a notable difference in ownership based on gender and health insurance status. Women had slightly higher ownership odds than men (OR 1.10, 95% CI 1.04-1.17). Private insurance increased ownership odds (OR 1.28, 95% CI 1.17-1.40), whereas being uninsured (OR 0.41, 95% CI 0.36-0.47) or on Medicaid (OR 0.75, 95% CI 0.68-0.82) decreased the odds of ownership. Interestingly, minority groups such as non-Hispanic Black (OR 1.14, 95% CI 1.03-1.25) and Hispanic/Latine (OR 1.20, 95% CI 1.10-1.31) respondents showed slightly higher ownership odds than other racial/ethnic groups. Conclusions: Our findings suggest that despite overall growth in wearable ownership, sociodemographic divides persist. The data indicate a need for equitable access strategies as wearables become integral to clinical and public health domains. %M 39058548 %R 10.2196/56504 %U https://www.jmir.org/2024/1/e56504 %U https://doi.org/10.2196/56504 %U http://www.ncbi.nlm.nih.gov/pubmed/39058548 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e50555 %T Efficacy of Mobile App–Based Cognitive Behavioral Therapy for Insomnia: Multicenter, Single-Blind Randomized Clinical Trial %A Shin,Jiyoon %A Kim,Sujin %A Lee,Jooyoung %A Gu,Hyerin %A Ahn,Jihye %A Park,Chowon %A Seo,Mincheol %A Jeon,Jeong Eun %A Lee,Ha Young %A Yeom,Ji Won %A Kim,Sojeong %A Yoon,Yeaseul %A Lee,Heon-Jeong %A Kim,Seog Ju %A Lee,Yu Jin %+ Department of Psychiatry and Center for Sleep and Chronobiology, Seoul National University Hospital, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea, 82 2 2072 2456, ewpsyche@snu.ac.kr %K digital therapeutics %K mobile app–based cognitive behavioral therapy for insomnia %K cognitive behavioral therapy %K insomnia %K mental health %K mobile phone %D 2024 %7 26.7.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Cognitive behavioral therapy for insomnia (CBTi) is the first-line therapy for chronic insomnia. Mobile app–based CBTi (MCBTi) can enhance the accessibility of CBTi treatment; however, few studies have evaluated the effectiveness of MCBTi using a multicenter, randomized controlled trial design. Objective: We aimed to assess the efficacy of Somzz, an MCBTi that provides real-time and tailored feedback to users, through comparison with an active comparator app. Methods: In our multicenter, single-blind randomized controlled trial study, participants were recruited from 3 university hospitals and randomized into a Somzz group and a sleep hygiene education (SHE) group at a 1:1 ratio. The intervention included 6 sessions for 6 weeks, with follow-up visits over a 4-month period. The Somzz group received audiovisual sleep education, guidance on relaxation therapy, and real-time feedback on sleep behavior. The primary outcome was the Insomnia Severity Index score, and secondary outcomes included sleep diary measures and mental health self-reports. We analyzed the outcomes based on the intention-to-treat principle. Results: A total of 98 participants were randomized into the Somzz (n=49, 50%) and SHE (n=49, 50%) groups. Insomnia Severity Index scores for the Somzz group were significantly lower at the postintervention time point (9.0 vs 12.8; t95=3.85; F2,95=22.76; ηp2=0.13; P<.001) and at the 3-month follow-up visit (11.3 vs 14.7; t68=2.61; F2,68=5.85; ηp2=0.03; P=.01) compared to those of the SHE group. The Somzz group maintained their treatment effect at the postintervention time point and follow-ups, with a moderate to large effect size (Cohen d=–0.62 to –1.35; P<.01 in all cases). Furthermore, the Somzz group showed better sleep efficiency (t95=–3.32; F2,91=69.87; ηp2=0.41; P=.001), wake after sleep onset (t95=2.55; F2,91=51.81; ηp2=0.36; P=.01), satisfaction (t95=–2.05; F2,91=26.63; ηp2=0.20; P=.04) related to sleep, and mental health outcomes, including depression (t95=2.11; F2,94=29.64; ηp2=0.21; P=.04) and quality of life (t95=–3.13; F2,94=54.20; ηp2=0.33; P=.002), compared to the SHE group after the intervention. The attrition rate in the Somzz group was 12% (6/49). Conclusions: Somzz outperformed SHE in improving insomnia, mental health, and quality of life. The MCBTi can be a highly accessible, time-efficient, and effective treatment option for chronic insomnia, with high compliance. Trial Registration: Clinical Research Information Service (CRiS) KCT0007292; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=22214&search_page=L %M 39058549 %R 10.2196/50555 %U https://www.jmir.org/2024/1/e50555 %U https://doi.org/10.2196/50555 %U http://www.ncbi.nlm.nih.gov/pubmed/39058549 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e57938 %T Changes in the Frequency of Actions Associated With Mental Health During Online Treatment: Analysis of Demographic and Clinical Factors %A Bisby,Madelyne %A Staples,Lauren %A Dear,Blake %A Titov,Nickolai %+ MindSpot Clinic, MQ Health, Macquarie University, 16 University Avenue, Sydney, 2109, Australia, 61 298508724, madelyne.bisby@mq.edu.au %K anxiety %K depression %K daily actions %K treatments %K personalization %K mental health %K digital treatment %K analysis %K clinical factors %K questionnaire %K depression symptoms %K anxiety symptoms %K patients %K Australian %K Australia %K digital psychology service %K psychology %K symptom severity %K severity %D 2024 %7 25.7.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Specific daily actions (eg, goal setting, meaningful activities) are associated with mental health. Performing specific daily actions at a higher frequency is associated with significantly lower baseline symptoms of depression and anxiety, as well as better psychological treatment outcomes for depression and anxiety. Objective: This study explored how the frequency of specific daily actions associated with mental health may differ prior to, during, and following treatment according to demographic and clinical characteristics. Methods: Using a sample of 448 patients from an Australian national digital psychology service, we examined baseline differences in daily action frequency and changes in daily action frequency during a digital psychological treatment according to demographic and clinical subgroups. A total of 5 specific types of daily actions were measured using the Things You Do Questionnaire: healthy thinking, meaningful activities, goals and plans, healthy habits, and social connections. Results: The frequency of daily actions differed according to employment status (largest P=.005) and educational level (largest P=.004). Daily action frequency was lower in those participants with more severe or chronic depression or anxiety symptoms (largest P=.004). Participants reported larger increases in how often they did these daily actions from baseline to midtreatment compared to mid- to posttreatment. Depression duration (P=.01) and severity (P<.001) were associated with differences in how daily action frequency changed during treatment. Conclusions: The findings of this study support continued research exploring the relationship between daily actions and mental health, how this relationship might differ between individuals, and the clinical potential of supporting individuals to increase the frequency of daily actions to improve mental health. %M 39052998 %R 10.2196/57938 %U https://formative.jmir.org/2024/1/e57938 %U https://doi.org/10.2196/57938 %U http://www.ncbi.nlm.nih.gov/pubmed/39052998 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53450 %T A Web-Based Resilience-Enhancing Program to Improve Resilience, Physical Activity, and Well-being in Geriatric Population: Randomized Controlled Trial %A Wu,Yi-Chen %A Shen,Shu-Fen %A Chen,Liang-Kung %A Tung,Heng-Hsin %+ Department of Nursing,National Yang Ming Chiao Tung University, No.155, Sec.2, Li-Nong Street, Pei-Tao district 112, Taipei, 11221, Taiwan, 886 0953005831, shannontung719@gmail.com %K geriatric population %K community-dwelling older adult %K web-based resilience-enhancing program %K resilience %K physical activity %K well-being %K pandemic. %D 2024 %7 25.7.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Resilience is a protective factor in healthy aging, helping to maintain and recover physical and mental functions. The Resilience in Illness Model has proven effective in fostering resilience and well-being. Physical activity is crucial for older adults’ independence and well-being, even as aging causes a progressive decline. Additionally, older adults face challenges such as spousal loss and physical disability, making preventive intervention strategies necessary. Objective: This study aims to develop and evaluate a web-based program to enhance resilience, physical activity, and well-being among community-dwelling older adults. Additionally, we aim to gather feedback on the program’s strengths and limitations. Methods: A 4-week resilience-enhancing program was created, incorporating role-play and talk-in-interaction and focusing on 3 key skills: coping, control belief, and manageability. The program included scenarios such as becoming widowed and suffering a stroke, designed to engage older adults. A pilot test preceded the intervention. As a result of the COVID-19 pandemic, the program shifted from in-person to web-based sessions. A single-blind, parallel-group, randomized controlled trial was conducted. Participants aged over 65 years were recruited offline and randomly assigned to either an intervention or control group. A certified resilience practitioner delivered the program. Outcomes in resilience, physical activity, and well-being were self-assessed at baseline (T0), 4 weeks (T1), and 12 weeks (T2) after the program. A mixed methods approach was used to evaluate feedback. Results: A web-based participatory program enhancing 3 skills—coping, control belief, and manageability for resilience—was well developed. Among 96 participants, 63 were randomized into the intervention group (n=31) and the control group (n=32). The mean age in the intervention group was 69.27 (SD 3.08) years and 74.84 (SD 6.23) years in the control group. Significant between-group differences at baseline were found in age (t45.6=–4.53, P<.001) and physical activity at baseline (t61=2.92, P=.005). No statistically significant between-group differences over time were observed in resilience (SE 7.49, 95% CI –10.74 to 18.61, P=.60), physical activity (SE 15.18, 95% CI –24.74 to 34.74, P=.74), and well-being (SE 3.74, 95% CI –2.68 to 11.98, P=.21) after controlling for baseline differences. The dropout rate was lower in the intervention group (2/31, 6%) compared with the control group (5/32, 16%). Moreover, 77% (24/31) of participants in the intervention group completed the entire program. Program feedback from the participants indicated high satisfaction with the web-based format and mentorship support. Conclusions: This study demonstrated that a web-based resilience-enhancing program is appropriate, acceptable, feasible, and engaging for community-dwelling older adults. The program garnered enthusiasm for its potential to optimize resilience, physical activity, and well-being, with mentorship playing a crucial role in its success. Future studies should aim to refine program content, engagement, and delivery methods to effectively promote healthy aging in this population. Trial Registration: ClinicalTrials.gov NCT05808491; https://clinicaltrials.gov/ct2/show/NCT05808491 %M 39052335 %R 10.2196/53450 %U https://www.jmir.org/2024/1/e53450 %U https://doi.org/10.2196/53450 %U http://www.ncbi.nlm.nih.gov/pubmed/39052335 %0 Journal Article %@ 2291-9694 %I JMIR Publications %V 12 %N %P e58886 %T Hjernetegn.dk—The Danish Central Nervous System Tumor Awareness Initiative Digital Decision Support Tool: Design and Implementation Report %A Weile,Kathrine Synne %A Mathiasen,René %A Winther,Jeanette Falck %A Hasle,Henrik %A Henriksen,Louise Tram %+ Department of Pediatric and Adolescent Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus, 8200, Denmark, 45 2927 9265, kathrineweile@clin.au.dk %K digital health initiative %K digital health initiatives %K clinical decision support %K decision support %K decision support system %K decision support systems %K decision support tool %K decision support tools %K diagnostic delay %K awareness initiative %K pediatric neurology %K pediatric neurology %K pediatric CNS tumors %K CNS tumor %K CNS tumour %K CNS tumours %K co-creation %K health systems and services %K communication %K central nervous system %D 2024 %7 25.7.2024 %9 Implementation Report %J JMIR Med Inform %G English %X Background: Childhood tumors in the central nervous system (CNS) have longer diagnostic delays than other pediatric tumors. Vague presenting symptoms pose a challenge in the diagnostic process; it has been indicated that patients and parents may be hesitant to seek help, and health care professionals (HCPs) may lack awareness and knowledge about clinical presentation. To raise awareness among HCPs, the Danish CNS tumor awareness initiative hjernetegn.dk was launched. Objective: This study aims to present the learnings from designing and implementing a decision support tool for HCPs to reduce diagnostic delay in childhood CNS tumors. The aims also include decisions regarding strategies for dissemination and use of social media, and an evaluation of the digital impact 6 months after launch. Methods: The phases of developing and implementing the tool include participatory co-creation workshops, designing the website and digital platforms, and implementing a press and media strategy. The digital impact of hjernetegn.dk was evaluated through website analytics and social media engagement. Implementation (Results): hjernetegn.dk was launched in August 2023. The results after 6 months exceeded key performance indicators. The analysis showed a high number of website visitors and engagement, with a plateau reached 3 months after the initial launch. The LinkedIn campaign and Google Search strategy also generated a high number of impressions and clicks. Conclusions: The findings suggest that the initiative has been successfully integrated, raising awareness and providing a valuable tool for HCPs in diagnosing childhood CNS tumors. The study highlights the importance of interdisciplinary collaboration, co-creation, and ongoing community management, as well as broad dissemination strategies when introducing a digital support tool. %M 39052326 %R 10.2196/58886 %U https://medinform.jmir.org/2024/1/e58886 %U https://doi.org/10.2196/58886 %U http://www.ncbi.nlm.nih.gov/pubmed/39052326 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e51307 %T Mobile App Intervention to Reduce Substance Use, Gambling, and Digital Media Use in Vocational School Students: Exploratory Analysis of the Intervention Arm of a Randomized Controlled Trial %A Grahlher,Kristin %A Morgenstern,Matthis %A Pietsch,Benjamin %A Gomes de Matos,Elena %A Rossa,Monika %A Lochbühler,Kirsten %A Daubmann,Anne %A Thomasius,Rainer %A Arnaud,Nicolas %+ German Centre for Addiction Research in Childhood and Adolescence, University Medical Centre Hamburg-Eppendorf, Martinistr 52, Hamburg, 20246, Germany, 49 40741059307, n.arnaud@uke.de %K prevention %K vocational students %K adolescents %K mobile intervention %K voluntary commitment %K substance use %K internet-related problems %K mobile phone %K adolescent %K youths %K student %K students %K use %D 2024 %7 23.7.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: During adolescence, substance use and digital media exposure usually peak and can become major health risks. Prevention activities are mainly implemented in the regular school setting, and youth outside this system are not reached. A mobile app (“Meine Zeit ohne”) has been developed specifically for vocational students and encourages participants to voluntarily reduce or abstain from a self-chosen addictive behavior including the use of a substance, gambling, or a media-related habit such as gaming or social media use for 2 weeks. Results from a randomized study indicate a significant impact on health-promoting behavior change after using the app. This exploratory study focuses on the intervention arm of this study, focusing on acceptance and differential effectiveness. Objective: The aims of this study were (1) to examine the characteristics of participants who used the app, (2) to explore the effectiveness of the mobile intervention depending on how the app was used and depending on participants’ characteristics, and (3) to study how variations in app use were related to participants’ baseline characteristics. Methods: Log data from study participants in the intervention group were analyzed including the frequency of app use (in days), selection of a specific challenge, and personal relevance (ie, the user was above a predefined risk score for a certain addictive behavior) of challenge selection (“congruent use”: eg, a smoker selected a challenge related to reducing or quitting smoking). Dichotomous outcomes (change vs no change) referred to past-month substance use, gambling, and media-related behaviors. The relationship between these variables was analyzed using binary, multilevel, mixed-effects logistic regression models. Results: The intervention group consisted of 2367 vocational students, and 1458 (61.6%; mean age 19.0, SD 3.5 years; 830/1458, 56.9% male) of them provided full data. Of these 1458 students, 894 (61.3%) started a challenge and could be included in the analysis (mean 18.7, SD 3.5 years; 363/894, 40.6% female). Of these 894 students, 466 (52.1%) were considered frequent app users with more than 4 days of active use over the 2-week period. The challenge area most often chosen in the analyzed sample was related to social media use (332/894, 37.1%). A total of 407 (45.5%) of the 894 students selected a challenge in a behavioral domain of personal relevance. The effects of app use on outcomes were higher when the area of individual challenge choice was equal to the area of behavior change, challenge choice was related to a behavior of personal relevance, and the individual risk of engaging in different addictive behaviors was high. Conclusions: The domain-specific effectiveness of the program was confirmed with no spillover between behavioral domains. Effectiveness appeared to be dependent on app use and users’ characteristics. Trial Registration: German Clinical Trials Register DRKS00023788; https://tinyurl.com/4pzpjkmj International Registered Report Identifier (IRRID): RR2-10.1186/s13063-022-06231-x %M 39042436 %R 10.2196/51307 %U https://mhealth.jmir.org/2024/1/e51307 %U https://doi.org/10.2196/51307 %U http://www.ncbi.nlm.nih.gov/pubmed/39042436 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e51400 %T Initial Perspectives From Rural-Residing Adults on a Digital Cognitive Health Coaching Intervention: Exploratory Qualitative Analysis %A Myers,Jennifer Rae %A Bryk,Kelsey N %A Madero,Erica N %A McFarlane,Jacob %A Campitelli,Anthony %A Gills,Joshua %A Jones,Megan %A Paulson,Sally %A Gray,Michelle %A Glenn,Jordan M %+ Neurotrack Technologies, 399 Bradford St #101, Redwood City, CA, 94063, United States, 1 6505498566, jennifer.r.myers@outlook.com %K Alzheimer disease %K cognition %K intervention %K rural issues %K digital health %K geriatric %K geriatrics %K elder %K elderly %K diabetes %K diabetes mellitus %K dementia %K digital cognitive health coaching %K rural %K countryside %K qualitative study %K thematic analysis %K mHealth %K telehealth %K health informatics %K mental health %K behavioral change %K healthy lifestyle %K coach support %K self-awareness %K prevention %D 2024 %7 22.7.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: A growing body of research has examined lifestyle-based interventions for dementia prevention. Specifically, health coaching interventions have been linked to decreased risk of Alzheimer disease (AD) comorbidities, such as diabetes. Despite the association, there is a lack of research examining the efficacy and perception of digital health coaching on reducing AD risk. Understanding the perceived benefits of participating in a digital health coach program is critical to ensure long-term use, including participant adherence and engagement. Objective: The purpose of this study is to examine the initial attitudes toward a digital health coaching intervention aimed at preventing cognitive decline among at-risk, rural participants. Methods: This exploratory qualitative study is part of the ongoing Digital Cognitive Multidomain Alzheimer Risk Velocity Study (DC-MARVel; ClinicalTrials.gov NCT04559789), a 2-year randomized control trial examining the effects of a digital health coaching intervention on dementia risk, cognitive decline, and general health outcomes. Participants were recruited from the northwest region of Arkansas via word of mouth, email, local radio, and social media. At the time of the analysis, 103 participants randomly assigned to the health coaching group completed an average of 4 coaching sessions over a 4-month period. The intervention included asynchronous messages 1-2 times per week from their health coach that contained health education articles based on the participant’s goals (eg, increase physical activity), unlimited access to their coach for questions and recommendations, and monthly meetings with their coach via videoconference or phone to discuss their goals. Participants were asked 2 open-ended questions, “What were your top 1 or 2 takeaways from your recent Health Coaching session?” and “Is there anything you would change about our Health Coaching sessions?” A thematic analysis was conducted using feedback responses from 80 participants (mean age, SD 7.6 years). Results: The following four themes emerged from participants’ feedback: (1) healthy lifestyle and behavioral changes, (2) a sense of self-awareness through introspection, (3) value in coach support, and (4) a desire for a change in program format (eg, frequency). In total, 93% (n=74) of participants expressed that the intervention needed no changes. Conclusions: Initial participation in the digital cognitive health coaching intervention was well received, as evidenced by participants reporting value in goal setting and strategies for healthy lifestyle and behavioral changes as well as self-reflection on their personal lifestyle choices. Feedback about their assigned coach also offers insight into the importance of the coach-participant relationship and may serve as a significant factor in overall participant success. Given the exploratory nature of this study, more robust research is needed to elicit more information from participants about their experiences to fully understand the acceptability of the digital health coaching intervention. Trial Registration: ClinicalTrials.gov NCT04559789; https://clinicaltrials.gov/show/NCT04559789 International Registered Report Identifier (IRRID): RR2-10.2196/31841 %M 39038282 %R 10.2196/51400 %U https://formative.jmir.org/2024/1/e51400 %U https://doi.org/10.2196/51400 %U http://www.ncbi.nlm.nih.gov/pubmed/39038282 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e55757 %T Digital Interventions for Self-Management of Type 2 Diabetes Mellitus: Systematic Literature Review and Meta-Analysis %A Kerr,David %A Ahn,David %A Waki,Kayo %A Wang,Jing %A Breznen,Boris %A Klonoff,David C %+ Center for Health Systems Research, Sutter Health, 2121 N. California Ave, Suite 309, Walnut Creek, CA, 94596, United States, 1 8056248688, david.kerr@sutterhealth.org %K coaching %K digital health %K eHealth %K meta-analysis %K patient empowerment %K patient engagement %K self-care %K systematic review %K telemedicine %K type 2 diabetes %K digital interventions %K self-management %K systematic literature review %K effectiveness %K efficacy %K safety %K meta-regression %D 2024 %7 22.7.2024 %9 Review %J J Med Internet Res %G English %X Background: The proliferation of digital technology has the potential to transform diabetes management. One of the critical aspects of modern diabetes management remains the achievement of glycemic targets to avoid acute and long-term complications. Objective: This study aims to describe the landscape of evidence pertaining to the relative effectiveness or efficacy and safety of various digital interventions for the self-management of type 2 diabetes mellitus (T2DM), with a primary focus on reducing glycated hemoglobin A1c (HbA1c) levels. Methods: A systematic literature review (SLR) was conducted by searching Embase, MEDLINE, and CENTRAL on April 5, 2022. Study selection, data extraction, and quality assessment were performed by 2 independent reviewers. Eligibility criteria for the SLR included randomized controlled trials (RCTs) and comparative observational studies evaluating interventions containing both human (eg, coaching) and digital components (eg, glucose meter) in adult patients with T2DM. The primary meta-analysis was restricted to studies that reported laboratory-measured HbA1c. In secondary analyses, meta-regression was performed with the intensity of coaching in the digital intervention as a categorical covariate. Results: In total, 28 studies were included in this analysis. Most studies (23/28, 82%) used the reduction of HbA1c levels as the primary end point, either directly or as a part of a multicomponent outcome. In total, 21 studies reported statistically significant results with this primary end point. When stratified into 3 intervention categories by the intensity of the intervention supporting the digital health technology (analyzing all 28 studies), the success rate appeared to be proportional to the coaching intensity (ie, higher-intensity studies reported higher success rates). When the analysis was restricted to RCTs using the comparative improvement of HbA1c levels, the effectiveness of the interventions was less clear. Only half (12/23, 52%) of the included RCTs reported statistically significant results. The meta-analyses were broadly aligned with the results of the SLR. The primary analysis estimated a greater reduction in HbA1c associated with digital interventions compared with usual care (–0.31%, 95% CI –0.45% to –0.16%; P<.001). Meta-regression estimated reductions of –0.45% (95% CI –0.81% to –0.09%; P=.02), –0.29% (95% CI –0.48% to –0.11%; P=.003), and –0.28% (95% CI –0.65% to 0.09%; P=.20) associated with high-, medium-, and low-intensity interventions, respectively. Conclusions: These findings suggest that reducing HbA1c levels in individuals with T2DM with the help of digital interventions is feasible, effective, and acceptable. One common feature of effective digital health interventions was the availability of timely and responsive personalized coaching by a dedicated health care professional. %M 39037772 %R 10.2196/55757 %U https://www.jmir.org/2024/1/e55757 %U https://doi.org/10.2196/55757 %U http://www.ncbi.nlm.nih.gov/pubmed/39037772 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e55786 %T Effectiveness of Unguided Internet-Based Cognitive Behavioral Therapy for Subthreshold Social Anxiety Disorder in Adolescents and Young Adults: Multicenter Randomized Controlled Trial %A Matsumoto,Kazuki %A Hamatani,Sayo %A Shiga,Kiko %A Iiboshi,Kiyoko %A Kasai,Makiko %A Kimura,Yasuhiro %A Yokota,Satoshi %A Watanabe,Katsunori %A Kubo,Yoko %A Nakamura,Masayuki %+ Division of Clinical Psychology, Kagoshima University Hospital, Research and Education Assembly Medical and Dental Sciences Area, Kagoshima University, 1-8-35 Sakuragaoka, Kagoshima, 8908520, Japan, 81 0992655707, k2782199@kadai.jp %K adolescent %K social anxiety disorder %K general anxiety %K adolescents %K teens %K social anxiety %K teenagers %K internet-based cognitive behavioral therapy %K self-help %K randomized controlled trials %K young adults %K cognitive behavioral therapy %K anxiety %K mental health %K students %K colleges %K universities %K social socialize %K anxious %K fear %K mobile phone %D 2024 %7 22.7.2024 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Social anxiety disorder (SAD) is a common mental disorder in adolescents and young adults. Early intervention and support could help prevent the development of full-blown SAD. Considering that adolescents with social anxiety symptoms do not prefer face-to-face sessions due to their fear of communicating with therapists, internet-based cognitive behavioral therapy (ICBT) was implemented. Objective: This study aimed to examine the effectiveness of complete self-help ICBT for subthreshold SAD in high school and college students with no history of mental disorders. Methods: A multicenter randomized controlled trial designed to demonstrate the objective was conducted from December 2022 to October 2023. Participants were students enrolled at 6 universities and 1 high school. The intervention was a complete self-help ICBT and consisted of 10 text-based sessions that taught cognitive behavioral therapy techniques for social anxiety in youths and young adults. The comparison was a no-treatment condition (control group), which was randomly assigned in a 1:1 ratio by a computer program. A total of 2 psychological scales were used to assess the severity of social anxiety, and 1 psychological scale each was used to measure symptoms of depression, general anxiety, and quality of life. Results: In total, 77 students were enrolled as study participants. Through the randomization procedure, 38 participants were included in the intervention group, and 39 patients were included in the control group. Results from the analysis of covariance with depression as covariates showed that the participants in the intervention group had significantly reduced symptoms of social anxiety, depression, and general anxiety compared to the control group. The response rate was 61% (19/31) in the intervention group and 24% (9/38) in the control group: odds ratio (OR) 4.97 (95% CI 1.61-16.53; P=.003) in the Fisher exact test. The recovery rate was 68% (21/31) in the intervention group and 34% (13/38) in the control group: OR 3.95 (95% CI 1.32-12.56; P=.008). The OR for the remission ratio was 2.01 (95% CI 0.64-6.60; P=.20) and for the risk of worsening was 0.23 (95% CI 0.002-1.33; P=.10), but no significant difference was observed. Conclusions: The results of this randomized controlled trial show that fully unguided ICBT improves subthreshold SAD in adolescents and young adults. Interpretation of the effectiveness in preventing SAD that meets the diagnostic criteria is limited by sample size and the follow-up period. Future studies should include more extended observations and larger sample sizes in high-risk populations. Trial Registration: UMIN-CTR UMIN000050064; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000057035 %M 39037759 %R 10.2196/55786 %U https://pediatrics.jmir.org/2024/1/e55786 %U https://doi.org/10.2196/55786 %U http://www.ncbi.nlm.nih.gov/pubmed/39037759 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e51943 %T Algorithmic Spaced Retrieval Enhances Long-Term Memory in Alzheimer Disease: Case-Control Pilot Study %A Smith,Amy M %A Marin,Anna %A DeCaro,Renee E %A Feinn,Richard %A Wack,Audrey %A Hughes,Gregory I %A Rivard,Nathaniel %A Umashankar,Akshay %A Turk,Katherine W %A Budson,Andrew E %+ Blank Slate Technologies, LLC, 4075 Wilson Blvd, Arlington, VA, 22203, United States, 1 2034018923, smitham192@gmail.com %K Alzheimer disease %K spaced retrieval %K mobile app %K assistive technology %K episodic memory %K semantic memory %K mobile phone %D 2024 %7 19.7.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Spaced retrieval is a learning technique that involves engaging in repeated memory testing after increasingly lengthy intervals of time. Spaced retrieval has been shown to improve long-term memory in Alzheimer disease (AD), but it has historically been difficult to implement in the everyday lives of individuals with AD. Objective: This research aims to determine, in people with mild cognitive impairment (MCI) due to AD, the efficacy and feasibility of a mobile app that combines spaced retrieval with a machine learning algorithm to enhance memory retention. Specifically, the app prompts users to answer questions during brief daily sessions, and a machine learning algorithm tracks each user’s rate of forgetting to determine the optimal spacing schedule to prevent anticipated forgetting. Methods: In this pilot study, 61 participants (young adults: n=21, 34%; healthy older adults: n=20, 33%; people with MCI due to AD: n=20, 33%) used the app for 4 weeks to learn new facts and relearn forgotten name-face associations. Participation during the 4-week period was characterized by using the app once per day to answer 15 questions about the facts and names. After the 4-week learning phase, participants completed 2 recognition memory tests approximately 1 week apart, which tested memory for information they had studied using the app as well as information they had not studied. Results: After using the mobile app for 1 month, every person with MCI due to AD demonstrated improvements in memory for new facts that they had studied via the app compared to baseline (P<.001). All but one person with MCI due to AD (19/20, 95%) showed improvements of more than 10 percentage points, comparable to the improvements shown by young adults and healthy older adults. Memory for name-face associations was similarly improved for all participant groups after using the app but to a lesser degree. Furthermore, for both new facts and name-face associations, we found no memory decay for any participant group after they took a break of approximately 1 week from using the app at the end of the study. Regarding usability, of the 20 people with MCI due to AD, 16 (80%) self-adhered to the app’s automated practice schedule, and half of them (n=10, 50%) expressed an interest in continuing to use it. Conclusions: These results demonstrate early evidence that spaced retrieval mobile apps are both feasible for people with early-stage AD to use in their everyday lives and effective for supporting memory retention of recently learned facts and name-face associations. %M 39028554 %R 10.2196/51943 %U https://formative.jmir.org/2024/1/e51943 %U https://doi.org/10.2196/51943 %U http://www.ncbi.nlm.nih.gov/pubmed/39028554 %0 Journal Article %@ 2291-5222 %I %V 12 %N %P e49393 %T The Impact of User Engagement With Exposure Components on Posttraumatic Stress Symptoms in an mHealth Mobile App: Secondary Analysis of a Randomized Controlled Trial %A Davis,C Adrian %A Miller,Madeleine %A McLean,Carmen P %K posttraumatic stress disorder %K PTSD %K mHealth apps %K user engagement %K mHealth interventions %K digital interventions %K veterans %D 2024 %7 18.7.2024 %9 %J JMIR Mhealth Uhealth %G English %X Background: Mobile mental health apps are a cost-effective option for managing mental health problems, such as posttraumatic stress disorder (PTSD). The efficacy of mobile health (mHealth) apps depends on engagement with the app, but few studies have examined how users engage with different features of mHealth apps for PTSD. Objective: This study aims to examine the relationship between app engagement indices and PTSD symptom reduction using data from an unblinded pilot randomized controlled trial of “Renew” (Vertical Design), an exposure-based app for PTSD with and without coaching support. Because exposure is an effective approach for treating PTSD, we expected that engagement with exposure activities would be positively related to symptom reduction, over and above overall app usage. Methods: Participants were veterans (N=69) with clinically significant PTSD symptoms who were recruited online using Facebook advertisements and invited to use the Renew app as often as they wanted over a 6-week period. Participants completed screening and assessments online but provided informed consent, toured the app, and completed feedback interviews via telephone. We assessed users’ self-reported PTSD symptoms before and after a 6-week intervention period and collected app usage data using a research-instrumented dashboard. To examine overall app engagement, we used data on the total time spent in the app, the number of log-in days, and the number of points that the user gained in the app. To examine engagement with exposure components, we used data on total time spent completing exposure activities (both in vivo and imaginal), the number of in vivo exposure activities completed, and the number of characters written in response to imaginal exposure prompts. We used hierarchical regression analyses to test the effect of engagement indices on change in PTSD symptoms. Results: Usage varied widely. Participants spent an average of 166.09 (SD 156.52) minutes using Renew, over an average of 14.7 (SD 10.71) mean log-in days. Engagement with the exposure components of the app was positively associated with PTSD symptom reduction (F6,62=2.31; P=.04). Moreover, this relationship remained significant when controlling for overall engagement with the app (ΔF3,62=4.42; P=.007). The number of characters written during imaginal exposure (β=.37; P=.009) and the amount of time spent completing exposure activities (β=.36; P=.03) were significant contributors to the model. Conclusions: To our knowledge, this is the first study to show a relationship between symptom improvement and engagement with the active therapeutic components of an mHealth app (ie, exposure) for PTSD. This relationship held when controlling for overall app use, which suggests that it was engagement with exposure, specifically, that was associated with symptom change. Future work to identify ways of promoting greater engagement with self-guided exposure may help improve the effectiveness of mHealth apps for PTSD. Trial Registration: ClinicalTrials.gov NCT04155736; https://clinicaltrials.gov/ct2/show/NCT04155736 %R 10.2196/49393 %U https://mhealth.jmir.org/2024/1/e49393 %U https://doi.org/10.2196/49393 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e42319 %T Evaluating the Acceptability of the Drink Less App and the National Health Service Alcohol Advice Web Page: Qualitative Interview Process Evaluation %A Oldham,Melissa %A Dina,Larisa-Maria %A Loebenberg,Gemma %A Perski,Olga %A Brown,Jamie %A Angus,Colin %A Beard,Emma %A Burton,Robyn %A Field,Matt %A Greaves,Felix %A Hickman,Matthew %A Kaner,Eileen %A Michie,Susan %A Munafò,Marcus R %A Pizzo,Elena %A Garnett,Claire %+ Behavioural Science and Health, University College London, 1-19 Torrington Place, London, WC1E 7HB, United Kingdom, 44 20 7679 883, m.oldham@ucl.ac.uk %K alcohol reduction %K digital intervention %K acceptability %K mobile health %K mHealth %K mobile phone %D 2024 %7 18.7.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: The extent to which interventions are perceived as acceptable to users impacts engagement and efficacy. Objective: In this study, we evaluated the acceptability of (1) the smartphone app Drink Less (intervention) and (2) the National Health Service (NHS) alcohol advice web page (usual digital care and comparator) among adult drinkers in the United Kingdom participating in a randomized controlled trial evaluating the effectiveness of the Drink Less app. Methods: A subsample of 26 increasing- and higher-risk drinkers (Alcohol Use Disorders Identification Test score≥8) assigned to the intervention group (Drink Less; n=14, 54%; female: n=10, 71%; age: 22-72 years; White: n=9, 64%) or usual digital care group (NHS alcohol advice web page; n=12, 46%; female: n=5, 42%; age: 23-68 years: White: n=9, 75%) took part in semistructured interviews. The interview questions were mapped on to the 7 facets of acceptability according to the Theoretical Framework of Acceptability: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy. Alongside these constructs, we also included a question on perceived personal relevance, which previous research has linked to acceptability and engagement. Framework and thematic analysis of data was undertaken. Results: The Drink Less app was perceived as being ethical, easy, user-friendly, and effective for the period the app was used. Participants reported particularly liking the tracking and feedback sections of the app, which they reported increased personal relevance and which resulted in positive affect when achieving their goals. They reported no opportunity cost. Factors such as negative affect when not meeting goals and boredom led to disengagement in the longer term for some participants. The NHS alcohol advice web page was rated as being easy and user-friendly with no opportunity costs. However, the information presented was not perceived as being personally relevant or effective in changing drinking behavior. Most participants reported neutral or negative affect, most participants thought the alcohol advice web page was accessible, and some participants reported ethical concerns around the availability of suggested resources. Some participants reported that it had acted as a starting point or a signpost to other resources. Participants in both groups discussed motivation to change and contextual factors such as COVID-19 lockdowns, which influenced their perceived self-efficacy regardless of their assigned intervention. Conclusions: Drink Less appears to be an acceptable digital intervention among the recruited sample. The NHS alcohol advice web page was generally considered unacceptable as a stand-alone intervention among the recruited sample, although it may signpost and help people access other resources and interventions. %M 39024575 %R 10.2196/42319 %U https://www.jmir.org/2024/1/e42319 %U https://doi.org/10.2196/42319 %U http://www.ncbi.nlm.nih.gov/pubmed/39024575 %0 Journal Article %@ 2562-7600 %I JMIR Publications %V 7 %N %P e54317 %T Embedding the Use of Patient Multimedia Educational Resources Into Cardiac Acute Care: Prospective Observational Study %A Hutchinson,Anastasia %A Khaw,Damien %A Malmstrom-Zinkel,Annika %A Winter,Natalie %A Dowling,Chantelle %A Botti,Mari %A McDonall,Joanne %+ Centre for Quality and Patient Safety Research—Epworth Partnership, Institute of Health Transformation, Faculty of Health, Deakin University, 185-187 Hoddle St, Richmond, Melbourne, VIC 3121, Australia, 61 0437101349, a.hutchinson@deakin.edu.au %K patient participation %K digital technology %K mHealth %K mobile health %K app %K apps %K digital health %K smartphone %K smartphones %K multimedia %K patient education %K education %K educational %K educate %K patient engagement %K nursing %K cardiac surgery %K cardiology %K cardiac %K cardio %K CCU %K cardiac care unit %K CCC %K complex cardiac care %K coronary care nursing %K nurse %K nurse %K COVID-19 %K SARS-COV-2 %K Coronavirus %K severe acute respiratory syndrome %K Coronavirus infections %K novel Coronavirus %D 2024 %7 18.7.2024 %9 Original Paper %J JMIR Nursing %G English %X Background: Multimedia interventions may play an important role in improving patient care and reducing the time constraints of patient-clinician encounters. The “MyStay Cardiac” multimedia resource is an innovative program designed to be accessed by adult patients undergoing cardiac surgery. Objective: The purpose of this study was to evaluate the uptake of the MyStay Cardiac both during and following the COVID-19 pandemic. Methods: A prospective observational study design was used that involved the evaluation of program usage data available from the digital interface of the multimedia program. Data on usage patterns were analyzed for a 30-month period between August 2020 and January 2023. Usage patterns were compared during and following the lifting of COVID-19 pandemic restrictions. Uptake of the MyStay Cardiac was measured via the type and extent of user activity data captured by the web-based information system. Results: Intensive care unit recovery information was the most accessed information, being viewed in approximately 7 of 10 usage sessions. Ward recovery (n=124/343, 36.2%), goal (n=114/343, 33.2%), and exercise (n=102/343, 29.7%) information were routinely accessed. Most sessions involved users exclusively viewing text-based information (n=210/343, 61.2%). However, in over one-third of sessions (n=132/342, 38.5%), users accessed video information. Most usage sessions occurred during the COVID-19 restriction phase of the study (August 2020-December 2021). Sessions in which video (P=.02, phi=0.124) and audio (P=.006, phi=0.161) media were accessed were significantly more likely to occur in the restriction phase compared to the postrestriction phase. Conclusions: This study found that the use of digital multimedia resources to support patient education was well received and integrated into their practice by cardiac nurses working in acute care during the COVID-19 pandemic. There was a pattern for greater usage of the MyStay Cardiac during the COVID-19 pandemic when access to the health service for nonfrontline, essential workers was limited. %M 39024556 %R 10.2196/54317 %U https://nursing.jmir.org/2024/1/e54317 %U https://doi.org/10.2196/54317 %U http://www.ncbi.nlm.nih.gov/pubmed/39024556 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 9 %N %P e56276 %T Service Users’ Experiences of a Nationwide Digital Type 2 Diabetes Self-Management Intervention (Healthy Living): Qualitative Interview Study %A Hawkes,Rhiannon E %A Benton,Jack S %A Cotterill,Sarah %A Sanders,Caroline %A French,David P %+ Manchester Centre for Health Psychology, Division of Psychology and Mental Health, School of Health Sciences, University of Manchester, Coupland 1 Building, Oxford Road, Manchester, M13 9PL, United Kingdom, 44 161 275 2584, rhiannon.hawkes@manchester.ac.uk %K type 2 diabetes %K digital interventions %K behavior change %K self-management %K implementation %K qualitative methods %D 2024 %7 18.7.2024 %9 Original Paper %J JMIR Diabetes %G English %X Background: Diabetes Self-Management Education and Support programs for people living with type 2 diabetes mellitus (T2DM) can increase glycemic control and reduce the risk of developing T2DM-related complications. However, the recorded uptake of these programs is low. Digital self-management interventions have the potential to overcome barriers associated with attendance at face-to-face sessions. Healthy Living is an evidence-based digital self-management intervention for people living with T2DM, based on the Healthy Living for People with Type 2 Diabetes (HeLP-Diabetes) intervention, which demonstrated effectiveness in a randomized controlled trial. NHS England has commissioned Healthy Living for national rollout into routine care. Healthy Living consists of web-based structured education and Tools components to help service users self-manage their condition, including setting goals. However, key changes were implemented during the national rollout that contrasted with the trial, including a lack of facilitated access from a health care professional and the omission of a moderated online support forum. Objective: This qualitative study aims to explore service users’ experiences of using Healthy Living early in the national rollout. Methods: A total of 19 participants were interviewed via telephone or a videoconferencing platform. Topics included users’ experiences and views of website components, their understanding of the intervention content, and the overall acceptability of Healthy Living. Transcripts were analyzed thematically using a framework approach. Results: Participants valued having trustworthy information that was easily accessible. The emotional management content resonated with the participants, prompting some to book an appointment with their general practitioners to discuss low mood. After completing the structured education, participants might have been encouraged to continue using the website if there was more interactivity (1) between the website and other resources and devices they were using for self-management, (2) with health professionals and services, and (3) with other people living with T2DM. There was consensus that the website was particularly useful for people who had been newly diagnosed with T2DM. Conclusions: Digital Diabetes Self-Management Education and Support programs offering emotional aspects of self-management are addressing an unmet need. Primary care practices could consider offering Healthy Living to people as soon as they are diagnosed with T2DM. Participants suggested ways in which Healthy Living could increase interaction with the website to promote continued long-term use. %M 39024002 %R 10.2196/56276 %U https://diabetes.jmir.org/2024/1/e56276 %U https://doi.org/10.2196/56276 %U http://www.ncbi.nlm.nih.gov/pubmed/39024002 %0 Journal Article %@ 2292-9495 %I %V 11 %N %P e52496 %T Using a Human-Centered Design Process to Evaluate and Optimize User Experience of a Website (InPACT at Home) to Promote Youth Physical Activity: Case Study %A Hasson,Rebecca E %A Xie,Michelle %A Tadikamalla,Dhiraj %A Beemer,Lexie R %K web-based interventions %K children %K adolescents %K child %K adolescent %K youth %K user experience %K website %K websites %K implementation science %K human-centered design %K human-centred design %K HCD %K web based %K home based %K interview %K heuristics %K interviews %K heuristic %K competitive analysis %K video %K videos %K YouTube %K physical activity %K exercise %K fitness %D 2024 %7 15.7.2024 %9 %J JMIR Hum Factors %G English %X Background: Web-based physical activity interventions often fail to reach the anticipated public health impact due to insufficient use by the intended audiences. Objective: The purpose of this study was to use a human-centered design process to optimize the user experience of the Interrupting Prolonged sitting with ACTivity (InPACT) at Home website to promote youth physical activity participation. Methods: Qualitative interviews were conducted to assess engagement and pain points with the InPACT at Home website. Interview data were used to create affinity maps to identify themes of user responses, conduct a heuristic evaluation according to Nielsen’s usability heuristics framework, and complete a competitive analysis to identify the strengths and weaknesses of competitors who offered similar products. Results: Key themes from end user interviews included liking the website design, finding the website difficult to navigate, and wanting additional features (eg, library of watched videos). The website usability issues identified were lack of labeling and categorization of exercise videos, hidden necessary actions and options hindering users from decision-making, error-prone conditions, and high cognitive load of the website. Competitive analysis results revealed that YouTube received the highest usability ratings followed by the Just Dance and Presidential Youth Fitness Program websites. Conclusions: Human-centered design approaches are useful for bringing end users and developers together to optimize user experience and impact public health. Future research is needed to examine the effectiveness of the InPACT at Home website redesign to attract new users and retain current users, with the end goal of increasing youth physical activity engagement. %R 10.2196/52496 %U https://humanfactors.jmir.org/2024/1/e52496 %U https://doi.org/10.2196/52496 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53541 %T Mindful Self-Compassion Smartphone Intervention for Worker Mental Health in Japan: Protocol for a Randomized Controlled Trial %A Kurosawa,Takumu %A Adachi,Koichiro %A Takizawa,Ryu %+ Department of Clinical Psychology, Graduate School of Education, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan, 81 358411397, takizawar-tky@umin.ac.jp %K self-compassion %K mindfulness %K smartphone apps %K preventive intervention %K mental health %K work performance %K smartphone intervention %K workers %K psychological support %K mindfulness meditation %K meditation %K work-related outcomes %K mobile phone %D 2024 %7 15.7.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Mental health problems among workers cause enormous losses to companies in Japan. However, workers have been considered to have limited access to psychological support because of time constraints, which makes it difficult for them to engage in face-to-face psychological support interventions. Objective: This study aimed to present an intervention protocol that describes a randomized controlled trial to examine whether brief guided mindfulness meditation (MM) or self-compassion meditation (SCM) provided by a smartphone app is effective for mental health and work-related outcomes among workers. Methods: This is an open-label, 3-arm randomized controlled trial. The participants will be recruited through an open call on relevant websites with the following inclusion criteria: (1) employees who are working more than 20 hours per week, (2) between the ages of 18 and 54 years, (3) not on a leave of absence, (4) not business owners or students, and (5) not currently diagnosed with a mental disorder and have a Kessler Psychological Distress Scale-6 score below 13 points. We will include 200 participants and randomly assign them to an SCM course (n=67), an MM course (n=67), and a waitlist group (n=66). The intervention groups (SCM and MM) will be instructed to engage in daily guided self-help, self-compassion, and MMs lasting 6-12 minutes per day over 4 weeks. Primary outcomes will include psychological distress and job performance, and secondary outcomes will include somatic symptoms, cognitive flexibility, self-esteem, self-compassion, perceived stress, well-being, emotion regulation, work engagement, anger, psychological safety, and creativity. All procedures were approved by the ethics committee of the University of Tokyo (22-326). All participants will be informed of the study via the websites, and written informed consent will be collected via web-based forms. Results: The recruitment of participants began in December 2022, and the intervention began in January 2023. As of September 2023, a total of 375 participants have been enrolled. The intervention and data collection were completed in late October 2023. Conclusions: This study will contribute to the development of effective self-care intervention content that will improve mental health, work performance, and related outcomes and promote mindful and self-compassionate attitudes when faced with distress. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000049466; https://tinyurl.com/23x8m8nf International Registered Report Identifier (IRRID): DERR1-10.2196/53541 %M 39008345 %R 10.2196/53541 %U https://www.researchprotocols.org/2024/1/e53541 %U https://doi.org/10.2196/53541 %U http://www.ncbi.nlm.nih.gov/pubmed/39008345 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e51506 %T Needs Expressed in Peer-to-Peer Web-Based Interactions Among People With Depression and Anxiety Disorders Hospitalized in a Mental Health Facility: Mixed Methods Study %A Storman,Dawid %A Jemioło,Paweł %A Sawiec,Zuzanna %A Swierz,Mateusz Jan %A Antonowicz,Ewa %A Bala,Malgorzata M %A Prokop-Dorner,Anna %+ Chair of Epidemiology and Preventive Medicine, Department of Hygiene and Dietetics, Jagiellonian University Medical College, Kopernika 7, Kraków, 31-034, Poland, 48 124223720, dawid.storman@uj.edu.pl %K anxiety disorders %K depression %K peer-to-peer web-based interactions %K needs %K psychiatric hospitalization %D 2024 %7 12.7.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Hospitalization in psychiatric wards is a necessary step for many individuals experiencing severe mental health issues. However, being hospitalized can also be a stressful and unsettling experience. It is crucial to understand and address the various needs of hospitalized individuals with psychiatric disorders to promote their overall well-being and support their recovery. Objective: Our objectives were to identify and describe individual needs related to mental hospitals through peer-to-peer interactions on Polish web-based forums among individuals with depression and anxiety disorders and to assess whether these needs were addressed by peers. Methods: We conducted a search of web-based forums focused on depression and anxiety and selected samples of 160 and 176 posts, respectively, until we reached saturation. A mixed methods analysis that included an in-depth content analysis, the Pearson χ2 test, and φ coefficient was used to evaluate the posts. Results: The most frequently identified needs were the same for depression and anxiety forums and involved informational (105/160, 65.6% and 169/393, 43%, respectively), social life (17/160, 10.6% and 90/393, 22.9%, respectively), and emotional (9/160, 5.6% and 66/393, 16.8%, respectively) needs. The results show that there is no difference in the expression of needs between the analyzed forums. The needs were directly (42/47, 89% vs 98/110, 89.1% of times for depression and anxiety, respectively) and not fully (27/47, 57% vs 86/110, 78.2% of times for depression and anxiety, respectively) addressed by forum users. In quantitative analysis, we found that depression-related forums had more posts about the need for informational support and rectification, the expression of anger, and seeking professional support. By contrast, anxiety-related forums had more posts about the need for emotional support; social life; and information concerning medications, hope, and motivation. The most common co-occurrence of expressed needs was between sharing own experience and the need for professional support, with a strong positive association. The qualitative analysis showed that users join web-based communities to discuss their fears and questions about psychiatric hospitals. The posts revealed 4 mental and emotional representations of psychiatric hospitals: the hospital as an unknown place, the ambivalence of presumptions and needs, the negative representation of psychiatric hospitals, and the people associated with psychiatric hospitals. The tone of the posts was mostly negative, with discussions revolving around negative stereotypes; traumatic experiences; and beliefs that increased anxiety, shock, and fright and deterred users from hospitalization. Conclusions: Our study demonstrates that web-based forums can provide a platform for individuals with depression and anxiety disorders to express a wide range of needs. Most needs were addressed by peers but not sufficiently. Mental health professionals can benefit from these findings by gaining insights into the unique needs and concerns of their patients, thus allowing for more effective treatment and support. %R 10.2196/51506 %U https://www.jmir.org/2024/1/e51506 %U https://doi.org/10.2196/51506 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e51216 %T Deconstructing Fitbit to Specify the Effective Features in Promoting Physical Activity Among Inactive Adults: Pilot Randomized Controlled Trial %A Takano,Keisuke %A Oba,Takeyuki %A Katahira,Kentaro %A Kimura,Kenta %+ Human Informatics and Interaction Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), 1-1-1 Higashi, Tsukuba, Ibaraki, 305-8566, Japan, 81 298491456, keisuke.takano@aist.go.jp %K wearable activity tracker %K mHealth %K mobile health %K motivation %K physical activity %K lifestyle %K smartwatch %K wearables %K Fitbit %K exercise %K fitness %K BCT %K behavior change technique %K behavior change %K motivation %K adherence %K engagement %D 2024 %7 12.7.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Wearable activity trackers have become key players in mobile health practice as they offer various behavior change techniques (BCTs) to help improve physical activity (PA). Typically, multiple BCTs are implemented simultaneously in a device, making it difficult to identify which BCTs specifically improve PA. Objective: We investigated the effects of BCTs implemented on a smartwatch, the Fitbit, to determine how each technique promoted PA. Methods: This study was a single-blind, pilot randomized controlled trial, in which 70 adults (n=44, 63% women; mean age 40.5, SD 12.56 years; closed user group) were allocated to 1 of 3 BCT conditions: self-monitoring (feedback on participants’ own steps), goal setting (providing daily step goals), and social comparison (displaying daily steps achieved by peers). Each intervention lasted for 4 weeks (fully automated), during which participants wore a Fitbit and responded to day-to-day questionnaires regarding motivation. At pre- and postintervention time points (in-person sessions), levels and readiness for PA as well as different aspects of motivation were assessed. Results: Participants showed excellent adherence (mean valid-wear time of Fitbit=26.43/28 days, 94%), and no dropout was recorded. No significant changes were found in self-reported total PA (dz<0.28, P=.40 for the self-monitoring group, P=.58 for the goal setting group, and P=.19 for the social comparison group). Fitbit-assessed step count during the intervention period was slightly higher in the goal setting and social comparison groups than in the self-monitoring group, although the effects did not reach statistical significance (P=.052 and P=.06). However, more than half (27/46, 59%) of the participants in the precontemplation stage reported progress to a higher stage across the 3 conditions. Additionally, significant increases were detected for several aspects of motivation (ie, integrated and external regulation), and significant group differences were identified for the day-to-day changes in external regulation; that is, the self-monitoring group showed a significantly larger increase in the sense of pressure and tension (as part of external regulation) than the goal setting group (P=.04). Conclusions: Fitbit-implemented BCTs promote readiness and motivation for PA, although their effects on PA levels are marginal. The BCT-specific effects were unclear, but preliminary evidence showed that self-monitoring alone may be perceived demanding. Combining self-monitoring with another BCT (or goal setting, at least) may be important for enhancing continuous engagement in PA. Trial Registration: Open Science Framework; https://osf.io/87qnb/?view_only=f7b72d48bb5044eca4b8ce729f6b403b %M 38996332 %R 10.2196/51216 %U https://mhealth.jmir.org/2024/1/e51216 %U https://doi.org/10.2196/51216 %U http://www.ncbi.nlm.nih.gov/pubmed/38996332 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e45422 %T The Effects of a Complex Interactive Multimodal Intervention on Personalized Stress Management Among Health Care Workers in China: Nonrandomized Controlled Study %A Liu,Wenhua %A Wang,Quan %A Zheng,Danli %A Mei,Junhua %A Lu,Jiajia %A Chen,Guohua %A Wang,Wei %A Ding,Fengfei %+ Department of Pharmacology, School of Basic Medical Science, Shanghai Medical College, Fudan University, No.130 Dong An Road, Xu hui district, Shanghai, 20032, China, 86 13476255813, Fengfei_ding@fudan.edu.cn %K multimodal intervention %K stress management %K health care workers %K perceived stress %K autonomic nervous system %K stress %K management %K mental health %K engagement %K human support %K physiological stress %K psychological stress %K social network %K mobile phone %D 2024 %7 12.7.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Health care workers (HCWs) frequently face multiple stressors at work, particularly those working night shifts. HCWs who have experienced distress may find it difficult to adopt stress management approaches, even if they are aware of the effects of stress and coping processes. Therefore, an individualized intervention may be required to assist distressed HCWs in bridging the “knowledge-practice” gap in stress management and effectively alleviating stress symptoms. Objective: The main objective of this research was to compare the effects of a complex interactive multimodal intervention (CIMI) to self-guided stress management interventions on stress symptoms of distressed HCWs, as measured by physiological (heart rate variability), psychological (perceived stress, mental distress, and subjective happiness), and sleep disorder (fatigue and sleepiness) indicators. Methods: We conducted a nonrandomized, controlled study in 2 Chinese general hospitals. The participants in this study were 245 HCWs who fulfilled at least 1 of the 3 dimensions on the Depression, Anxiety, and Stress Scale. All eligible individuals were required to complete a questionnaire and wear a 24-hour Holter device to determine the physiological signs of stress as indexed by heart rate variability at both baseline and after the intervention. The CIMI group received a 12-week online intervention with 4 components—mobile stress management instruction, a web-based WeChat social network, personalized feedback, and a nurse coach, whereas the control group simply received a self-guided intervention. Results: After a 12-week intervention, the Perceived Stress Scale (PSS) scores reduced significantly in the CIMI group (mean difference [MD] –5.31, 95% CI –6.26 to –4.37; P<.001) compared to the baseline levels. The changes in PSS scores before and after the intervention exhibited a significant difference between the CIMI and control groups (d=–0.64; MD –4.03, 95% CI –5.91 to –2.14; P<.001), and the effect was medium. In terms of physiological measures, both the control group (MD –9.56, 95% CI –16.9 to –2.2; P=.01) and the CIMI group (MD –8.45, 95% CI –12.68 to –4.22; P<.001) demonstrated a significant decrease in the standard deviation of normal-to-normal intervals (SDNN) within the normal clinical range; however, there were no significant differences between the 2 groups (d=0.03; MD 1.11, 95% CI –7.38 to 9.59; P=.80). Conclusions: The CIMI was an effective intervention for improving sleep disorders, as well as parts of the psychological stress measures in distressed HCWs. The findings provide objective evidence for developing a mobile stress management intervention that is adaptable and accessible to distressed HCWs, but its long-term effects should be investigated in future research. Trial Registration: ClinicalTrials.gov NCT05239065; https://clinicaltrials.gov/ct2/show/NCT05239065 %M 38996333 %R 10.2196/45422 %U https://www.jmir.org/2024/1/e45422 %U https://doi.org/10.2196/45422 %U http://www.ncbi.nlm.nih.gov/pubmed/38996333 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56608 %T Web-Based Group Conversational Intervention on Cognitive Function and Comprehensive Functional Status Among Japanese Older Adults: Protocol for a 6-Month Randomized Controlled Trial %A Miura,Kumi Watanabe %A Kudo,Takashi %A Otake-Matsuura,Mihoko %+ Center for Advanced Intelligence Project, RIKEN, Nihonbashi 1-chome Mitsui Building, 15th floor 1-4-1 Nihonbashi, Tokyo, 103-0027, Japan, 81 3 6225 2482, mihoko.otake@riken.jp %K randomized controlled trial %K web-based intervention %K communication technology %K cognitive health %K neural blood markers %K social isolation %K well-being %D 2024 %7 11.7.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Social communication is a key factor in maintaining cognitive function and contributes to well-being in later life. Objective: This study will examine the effects of “Photo-Integrated Conversation Moderated by Application version 2” (PICMOA-2), which is a web-based conversational intervention, on cognitive performance, frailty, and social and psychological indicators among community-dwelling older adults. Methods: This study is a randomized controlled trial with an open-label, 2-parallel group trial and 1:1 allocation design. Community dwellers aged 65 years and older were enrolled in the trial and divided into the intervention and control groups. The intervention group receives the PICMOA-2 program, a web-based group conversation, once every 2 weeks for 6 months. The primary outcome is verbal fluency, including phonemic and semantic fluency. The secondary outcomes are other neuropsychiatric batteries, including the Mini-Mental State Examination, Logical Memory (immediate and delay), verbal paired associates, and comprehensive functional status evaluated by questionnaires, including frailty, social status, and well-being. The effect of the intervention will be examined using a mixed linear model. As a secondary aim, we will test whether the intervention effects vary with the covariates at baseline to examine the effective target attributes. Results: Recruitment was completed in July 2023. A total of 66 participants were randomly allocated to intervention or control groups. As of January 1, 2024, the intervention is ongoing. Participants are expected to complete the intervention at the end of February 2024, and the postintervention evaluation will be conducted in March 2024. Conclusions: This protocol outlines the randomized controlled trial study design evaluating the effect of a 6-month intervention with PICMOA-2. This study will provide evidence on the effectiveness of social interventions on cognitive function and identify effective target images for remote social intervention. Trial Registration: UMIN Clinical Trials UMIN000050877; https://tinyurl.com/5eahsy66 International Registered Report Identifier (IRRID): DERR1-10.2196/56608 %M 38990615 %R 10.2196/56608 %U https://www.researchprotocols.org/2024/1/e56608 %U https://doi.org/10.2196/56608 %U http://www.ncbi.nlm.nih.gov/pubmed/38990615 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 10 %N %P e49703 %T Usability and Preliminary Efficacy of an Adaptive Supportive Care System for Patients With Cancer: Pilot Randomized Controlled Trial %A Baik,Sharon H %A Clark,Karen %A Sanchez,Marisol %A Loscalzo,Matthew %A Celis,Ashley %A Razavi,Marianne %A Yang,Dershung %A Dale,William %A Haas,Niina %+ Department of Supportive Care Medicine, City of Hope, 1500 East Duarte Road, Duarte, CA, 91010, United States, 1 626 256 4673, shbaik@coh.org %K cancer %K distress screening %K eHealth %K supportive care %K mobile phone %D 2024 %7 10.7.2024 %9 Original Paper %J JMIR Cancer %G English %X Background: Using an iterative user-centered design process, our team developed a patient-centered adaptive supportive care system, PatientCareAnywhere, that provides comprehensive biopsychosocial screening and supportive cancer care to patients across the continuum of care adaptively. The overarching goal of PatientCareAnywhere is to improve health-related quality of life (HRQOL) and self-efficacy of patients with cancer by empowering them with self-management skills and bringing cancer care support directly to them at home. Such support is adaptive to the patient’s needs and health status and coordinated across multiple sources in the forms of referrals, education, engagement of community resources, and secure social communication. Objective: This study aims to assess the usability of the new web-based PatientCareAnywhere system and examine the preliminary efficacy of PatientCareAnywhere to improve patient-reported outcomes compared with usual care. Methods: For phase 1, usability testing participants included patients with cancer (n=4) and caregivers (n=7) who evaluated the software prototype and provided qualitative (eg, interviews) and quantitative (eg, System Usability Scale) feedback. For phase 2, participants in the 3-month pilot randomized controlled trial were randomized to receive the PatientCareAnywhere intervention (n=36) or usual care control condition (n=36). HRQOL and cancer-relevant self-efficacy were assessed at baseline (preintervention assessment) and 12 weeks from baseline (postintervention assessment); mean differences between pre- and postintervention scores were compared between the 2 groups. Results: Participants were highly satisfied with the prototype and reported above-average acceptable usability, with a mean System Usability Scale score of 84.09 (SD 10.02). Qualitative data supported the overall usability and perceived usefulness of the intervention, with a few design features (eg, “help request” function) added based on participant feedback. With regard to the randomized controlled trial, patients in the intervention group reported significant improvements in HRQOL from pre- to postintervention scores (mean difference 6.08, SD 15.26) compared with the control group (mean difference −2.95, SD 10.63; P=.01). In contrast, there was no significant between-group difference in self-efficacy (P=.09). Conclusions: Overall, PatientCareAnywhere represents a user-friendly, functional, and acceptable supportive care intervention with preliminary efficacy to improve HRQOL among patients diagnosed with cancer. Future studies are needed to further establish the efficacy of PatientCareAnywhere as well as explore strategies to enhance user engagement and investigate the optimal intensity, frequency, and use of the intervention to improve patient outcomes. Trial Registration: ClinicalTrials.gov NCT02408406; https://clinicaltrials.gov/study/NCT02408406 %M 38986134 %R 10.2196/49703 %U https://cancer.jmir.org/2024/1/e49703 %U https://doi.org/10.2196/49703 %U http://www.ncbi.nlm.nih.gov/pubmed/38986134 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e47785 %T Interactive Health Technology Tool for Kidney Living Donor Assessment to Standardize the Informed Consent Process: Usability and Qualitative Content Analysis %A Ortiz,Fernanda %A Grasberger,Juulia %A Ekstrand,Agneta %A Helanterä,Ilkka %A Giunti,Guido %+ Abdominal Center–Nephrology, Helsinki University Hospital, Haartmaninkatu 4, Helsinki, 00130, Finland, 358 504270795, fernanda.ortiz@hus.fi %K eHealth %K kidney living donor %K informed consent %K telemedicine %K process standardization %K kidney %K donor %K tool %K usability %K psychological impact %K utility %K smartphone %K coping %K surgery %D 2024 %7 9.7.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Kidney living donation carries risks, yet standardized information provision regarding nephrectomy risks and psychological impacts for candidates remains lacking. Objective: This study assesses the benefit of interactive health technology in improving the informed consent process for kidney living donation. Methods: The Kidney Hub institutional open portal offers comprehensive information on kidney disease and donation. Individuals willing to start the kidney living donation process at Helsinki University Hospital (January 2019-January 2022) were invited to use the patient-tailored digital care path (Living Donor Digital Care Path) included in the Kidney Hub. This platform provides detailed donation process information and facilitates communication between health care professionals and patients. eHealth literacy was evaluated via the eHealth Literacy Scale (eHEALS), usability with the System Usability Scale (SUS), and system utility through Likert-scale surveys with scores of 1-5. Qualitative content analysis addressed an open-ended question. Results: The Kidney Hub portal received over 8000 monthly visits, including to its sections on donation benefits (n=1629 views) and impact on donors’ lives (n=4850 views). Of 127 living kidney donation candidates, 7 did not use Living Donor Digital Care Path. Users’ ages ranged from 20 to 79 years, and they exchanged over 3500 messages. A total of 74 living donor candidates participated in the survey. Female candidates more commonly searched the internet about kidney donation (n=79 female candidates vs n=48 male candidates; P=.04). The mean eHEALS score correlated with internet use for health decisions (r=0.45; P<.001) and its importance (r=0.40; P=.01). Participants found that the Living Donor Digital Care Path was technically satisfactory (mean SUS score 4.4, SD 0.54) and useful but not pivotal in donation decision-making. Concerns focused on postsurgery coping for donors and recipients. Conclusions: Telemedicine effectively educates living kidney donor candidates on the donation process. The Living Donor Digital Care Path serves as a valuable eHealth tool, aiding clinicians in standardizing steps toward informed consent. Trial Registration: ClinicalTrials.gov NCT04791670; https://clinicaltrials.gov/study/NCT04791670 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2021-051166 %M 38981119 %R 10.2196/47785 %U https://formative.jmir.org/2024/1/e47785 %U https://doi.org/10.2196/47785 %U http://www.ncbi.nlm.nih.gov/pubmed/38981119 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e62891 %T Authors’ Reply: The Power of Collaboration in Facilitating Mobile Technology Adoption in Health Care %A Tong,Huong Ly %A Rakic,Severin %A Al-Hazzaa,Hazzaa M %A Alqahtani,Saleh A %+ The World Bank Group, J5-068, 1818 H Street NW, Washington, DC, 20433, United States, 1 2024585552, srakic@worldbank.org %K mobile apps %K fitness trackers %K SMS %K SMS text messaging %K physical activity %K exercise %K sedentary behavior %K Middle East %K Africa, Northern %K movement %K physical inactivity %K smartphone %K mobile phone %K mobile health %K mHealth %K digital health %K behavior change %K intervention %D 2024 %7 8.7.2024 %9 Letter to the Editor %J J Med Internet Res %G English %X %M 38976872 %R 10.2196/62891 %U https://www.jmir.org/2024/1/e62891 %U https://doi.org/10.2196/62891 %U http://www.ncbi.nlm.nih.gov/pubmed/38976872 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e60350 %T The Power of Collaboration in Facilitating Mobile Technology Adoption in Health Care %A Fan,Weijing %A Liu,Guobin %+ Department of Peripheral Vascular Surgery, Institute of Surgery of Traditional Chinese Medicine, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Zhangheng road 528, Shanghai, 201203, China, 86 15800885533, 15800885533@163.com %K social workers %K government %K mobile technology %K mobile apps %K fitness trackers %K SMS %K SMS text messaging %K physical activity %K exercise %K sedentary behavior %K Middle East %K Africa %K movement %K physical inactivity %K smartphone %K mobile phone %K mobile health %K mHealth %K digital health %K behavior change %K intervention %D 2024 %7 8.7.2024 %9 Letter to the Editor %J J Med Internet Res %G English %X %M 38976864 %R 10.2196/60350 %U https://www.jmir.org/2024/1/e60350 %U https://doi.org/10.2196/60350 %U http://www.ncbi.nlm.nih.gov/pubmed/38976864 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e58063 %T A Novel mHealth App for Smokers Living With HIV Who Are Ambivalent About Quitting Smoking: Formative Research and Randomized Feasibility Study %A McClure,Jennifer B %A Heffner,Jaimee L %A Krakauer,Chloe %A Mun,Sophia %A Catz,Sheryl L %+ Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Suite 1360, Seattle, WA, 98101, United States, 1 206 287 2737, Jennifer.B.McClure@kp.org %K HIV %K tobacco %K nicotine %K smoking cessation %K mobile health %K mHealth %K motivation %K ambivalence %K app %K mobile phone %D 2024 %7 8.7.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: More people who smoke and are living with HIV now die from tobacco-related diseases than HIV itself. Most people are ambivalent about quitting smoking and want to quit someday but not yet. Scalable, effective interventions are needed to motivate and support smoking cessation among people ambivalent about quitting smoking (PAQS) who are living with HIV. Objective: This study aims to develop an app-based intervention for PAQS who are living with HIV and assess its feasibility, acceptability, and potential impact. Results of this study will inform plans for future research and development. Methods: In phase 1, PAQS living with HIV (n=8) participated in user-centered design interviews to inform the final intervention app design and recruitment plan for a subsequent randomized pilot study. In phase 2, PAQS living with HIV were randomized to either a standard care control app or a similar experimental app with additional content tailored for PAQS and those with HIV. Participants were followed for 3 months. Feasibility focused on recruitment, retention, and participants’ willingness to install the app. The study was not powered for statistical significance. Indices of acceptability (satisfaction and use) and impact (smoking behavior change and treatment uptake) were assessed via automated data and self-report among those who installed and used the app (n=19). Results: Recruitment for both study phases was a challenge, particularly via web-based and social media platforms. Enrollment success was greater among people living with HIV recruited from a health care provider and research registry. Once enrolled, retention for the phase 2 randomized study was good; 74% (14/19) of the participants completed the 3-month follow-up. Phase 1 findings suggested that PAQS living with HIV were receptive to using an app-based intervention to help them decide whether, when, and how to stop smoking, despite not being ready to quit smoking. Phase 2 findings further supported this conclusion based on feedback from people who agreed to use an app, but group differences were observed. Indices of acceptability favored the experimental arm, including a descriptively higher mean number of sessions and utilization badges. Similarly, indices of potential impact were descriptively higher in the experimental arm (proportion reducing smoking, making a quit attempt, or calling free tobacco quitline). No participants in either arm quit smoking at the 3-month follow-up. Conclusions: On the basis of this formative work, PAQS living with HIV may be receptive to using a mobile health–based app intervention to help them decide whether, when, or how to stop using tobacco. Indices of acceptability and impact indicate that additional research and development are warranted. Trial Registration: ClinicalTrials.gov NCT05339659; https://clinicaltrials.gov/study/NCT05339659 %M 38976321 %R 10.2196/58063 %U https://formative.jmir.org/2024/1/e58063 %U https://doi.org/10.2196/58063 %U http://www.ncbi.nlm.nih.gov/pubmed/38976321 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e56664 %T Self-Management Using eHealth Technologies for Liver Transplant Recipients: Scoping Review %A Kim,Soo Hyun %A Kim,Kyoung-A %A Chu,Sang Hui %A Kim,Hyunji %A Joo,Dong Jin %A Lee,Jae Geun %A Choi,JiYeon %+ College of Nursing, Mo-Im Kim Nursing Research Institute, Institute for Innovation in Digital Healthcare, Yonsei University, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea, 82 2 2228 3301, jychoi610@yuhs.ac %K liver transplantation %K self-management %K transplant management %K eHealth %K eHealth technology %K digital health %K review %K mobile phone %K liver transplant %K liver disease %K scoping review %D 2024 %7 4.7.2024 %9 Review %J J Med Internet Res %G English %X Background: Liver transplantation has become increasingly common as a last-resort treatment for end-stage liver diseases and liver cancer, with continually improving success rates and long-term survival rates. Nevertheless, liver transplant recipients face lifelong challenges in self-management, including immunosuppressant therapy, lifestyle adjustments, and navigating complex health care systems. eHealth technologies hold the potential to aid and optimize self-management outcomes, but their adoption has been slow in this population due to the complexity of post–liver transplant management. Objective: This study aims to examine the use of eHealth technologies in supporting self-management for liver transplant recipients and identify their benefits and challenges to suggest areas for further research. Methods: Following the Arksey and O’Malley methodology for scoping reviews, we conducted a systematic search of 5 electronic databases: PubMed, CINAHL, Embase, PsycINFO, and Web of Science. We included studies that (1) examined or implemented eHealth-based self-management, (2) included liver transplant recipients aged ≥18 years, and (3) were published in a peer-reviewed journal. We excluded studies that (1) were case reports, conference abstracts, editorials, or letters; (2) did not focus on the posttransplantation phase; (3) did not focus on self-management; and (4) did not incorporate the concept of eHealth or used technology solely for data collection. The quality of the selected eHealth interventions was evaluated using (1) the Template for Intervention Description and Replication guidelines and checklist and (2) the 5 core self-management skills identified by Lorig and Holman. Results: Of 1461 articles, 15 (1.03%) studies were included in the final analysis. Our findings indicate that eHealth-based self-management strategies for adult liver transplant recipients primarily address lifestyle management, medication adherence, and remote monitoring, highlighting a notable gap in alcohol relapse interventions. The studies used diverse technologies, including mobile apps, videoconferencing, and telehealth platforms, but showed limited integration of decision-making or resource use skills essential for comprehensive self-management. The reviewed studies highlighted the potential of eHealth in enhancing individualized health care, but only a few included collaborative features such as 2-way communication or tailored goal setting. While adherence and feasibility were generally high in many interventions, their effectiveness varied due to diverse methodologies and outcome measures. Conclusions: This scoping review maps the current literature on eHealth-based self-management support for liver transplant recipients, assessing its potential and challenges. Future studies should focus on developing predictive models and personalized eHealth interventions rooted in patient-generated data, incorporating digital human-to-human interactions to effectively address the complex needs of liver transplant recipients. This review emphasizes the need for future eHealth self-management research to address the digital divide, especially with the aging liver transplant recipient population, and ensure more inclusive studies across diverse ethnicities and regions. %M 38963937 %R 10.2196/56664 %U https://www.jmir.org/2024/1/e56664 %U https://doi.org/10.2196/56664 %U http://www.ncbi.nlm.nih.gov/pubmed/38963937 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e47565 %T Efficacy of COMPAs, an App Designed to Support Communication Between Persons Living With Dementia in Long-Term Care Settings and Their Caregivers: Mixed Methods Implementation Study %A Ansaldo,Ana Inés %A Masson-Trottier,Michèle %A Delacourt,Barbara %A Dubuc,Jade %A Dubé,Catherine %+ Laboratoire de Plasticité cérébrale, Communication et Vieillissement, Centre de recherche de l'Institut Universitaire de gériatrie de Montréal, Université de Montréal, 4565 Queen Mary Road, Montréal, QC, H3W1W5, Canada, 1 5143403540 ext 3933, ana.ines.ansaldo@umontreal.ca %K dementia %K communication %K caregivers %K technology %K burden %K mixed methods design %K quality of life %K mobile phone %K tablet %D 2024 %7 4.7.2024 %9 Original Paper %J JMIR Aging %G English %X Background: Persons living with dementia experience autonomy loss and require caregiver support on a daily basis. Dementia involves a gradual decline in communication skills, leading to fewer interactions and isolation for both people living with dementia and their caregivers, negatively impacting the quality of life for both members of the dyad. The resulting stress and burden on caregivers make them particularly susceptible to burnout. Objective: This study aims to examine the efficacy of Communication Proches Aidants (COMPAs), an app designed following the principles of person-centered and emotional communication, which is intended to improve well-being in persons living with dementia and caregivers and reduce caregiver burden. Methods: In this implementation study, volunteer caregivers in 2 long-term care facilities (n=17) were trained in using COMPAs and strategies to improve communication with persons living with dementia. Qualitative and quantitative analyses, semistructured interviews, and questionnaires were completed before and after 8 weeks of intervention with COMPAs. Results: Semistructured interviews revealed that all caregivers perceived a positive impact following COMPAs interventions, namely, improved quality of communication and quality of life among persons living with dementia and caregivers. Improved quality of life was also supported by a statistically significant reduction in the General Health Questionnaire-12 scores (caregivers who improved: 9/17, 53%; z=2.537; P=.01). COMPAs interventions were also associated with a statistically significant increased feeling of personal accomplishment (caregivers improved: 11/17, 65%; t15=2.430; P=.03; d=0.61 [medium effect size]). Conclusions: COMPAs intervention improved well-being in persons living with dementia and their caregivers by developing person-centered communication within the dyad, increasing empathy, and reducing burden in caregivers although most caregivers were unfamiliar with technology. The results hold promise for COMPAs interventions in long-term care settings. Larger group-controlled studies with different populations, in different contexts, and at different stages of dementia will provide a clearer picture of the benefits of COMPAs interventions. %M 38963691 %R 10.2196/47565 %U https://aging.jmir.org/2024/1/e47565 %U https://doi.org/10.2196/47565 %U http://www.ncbi.nlm.nih.gov/pubmed/38963691 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e55663 %T Effect of a Smartphone App (S-Check) on Actual and Intended Help-Seeking and Motivation to Change Methamphetamine Use Among Adult Consumers of Methamphetamine in Australia: Randomized Waitlist-Controlled Trial %A Siefried,Krista J %A Bascombe,Florence %A Clifford,Brendan %A Liu,Zhixin %A Middleton,Peter %A Kay-Lambkin,Frances %A Freestone,Jack %A Herman,Daniel %A Millard,Michael %A Steele,Maureen %A Acheson,Liam %A Moller,Carl %A Bath,Nicky %A Ezard,Nadine %+ The National Centre for Clinical Research on Emerging Drugs, University of New South Wales, UNSW Randwick Campus, 22/32 King Street, Randwick, 2031, Australia, 61 2 9065 7808, krista.siefried@svha.org.au %K methamphetamine %K smartphone app %K behavior change %K help-seeking %K motivation to change %K mHealth %K mobile health %K app %K apps %K application %K applications %K smartphone %K smartphones %K motivation %K motivational %K RCT %K randomized %K controlled trial %K controlled trials %K drug %K drugs %K substance use %K engagement %K substance abuse %K mobile phone %D 2024 %7 3.7.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Interventions are required that address delays in treatment-seeking and low treatment coverage among people consuming methamphetamine. Objective: We aim to determine whether a self-administered smartphone-based intervention, the “S-Check app” can increase help-seeking and motivation to change methamphetamine use, and determine factors associated with app engagement. Methods: This study is a randomized, 28-day waitlist-controlled trial. Consenting adults residing in Australia who reported using methamphetamine at least once in the last month were eligible to download the app for free from Android or iOS app stores. Those randomized to the intervention group had immediate access to the S-Check app, the control group was wait-listed for 28 days before gaining access, and then all had access until day 56. Actual help-seeking and intention to seek help were assessed by the modified Actual Help Seeking Questionnaire (mAHSQ), modified General Help Seeking Questionnaire, and motivation to change methamphetamine use by the modified readiness ruler. χ2 comparisons of the proportion of positive responses to the mAHSQ, modified General Help Seeking Questionnaire, and modified readiness ruler were conducted between the 2 groups. Logistic regression models compared the odds of actual help-seeking, intention to seek help, and motivation to change at day 28 between the 2 groups. Secondary outcomes were the most commonly accessed features of the app, methamphetamine use, feasibility and acceptability of the app, and associations between S-Check app engagement and participant demographic and methamphetamine use characteristics. Results: In total, 560 participants downloaded the app; 259 (46.3%) completed eConsent and baseline; and 84 (32.4%) provided data on day 28. Participants in the immediate access group were more likely to seek professional help (mAHSQ) at day 28 than those in the control group (n=15, 45.5% vs n=12, 23.5%; χ21=4.42, P=.04). There was no significant difference in the odds of actual help-seeking, intention to seek help, or motivation to change methamphetamine use between the 2 groups on the primary logistic regression analyses, while in the ancillary analyses, the imputed data set showed a significant difference in the odds of seeking professional help between participants in the immediate access group compared to the waitlist control group (adjusted odds ratio 2.64, 95% CI 1.19-5.83, P=.02). For participants not seeking help at baseline, each minute in the app increased the likelihood of seeking professional help by day 28 by 8% (ratio 1.08, 95% CI 1.02-1.22, P=.04). Among the intervention group, a 10-minute increase in app engagement time was associated with a decrease in days of methamphetamine use by 0.4 days (regression coefficient [β] –0.04, P=.02). Conclusions: The S-Check app is a feasible low-resource self-administered intervention for adults in Australia who consume methamphetamine. Study attrition was high and, while common in mobile health interventions, warrants larger studies of the S-Check app. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619000534189; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377288&isReview=true %M 38959499 %R 10.2196/55663 %U https://mhealth.jmir.org/2024/1/e55663 %U https://doi.org/10.2196/55663 %U http://www.ncbi.nlm.nih.gov/pubmed/38959499 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e56755 %T Barriers to, and Facilitators of, Checking Drugs for Adulterants in the Era of Fentanyl and Xylazine: Qualitative Study %A Aronson,Ian David %A Ardouin-Guerrier,Mary-Andrée %A Baus,Juan Esteban %A Bennett,Alex S %+ Center for Technology-based Education and Community Health, NDRI-USA, 31 W 34th St Suite 8006, New York, NY, 10001, United States, 1 212 845 4444, aronson@ndri-usa.org %K overdose %K overdoses %K fentanyl %K xylazine %K benzodiazepines %K adulterants %K drug %K drugs %K substance %K substances %K illicit drug %K illicit drugs %K drug test %K drug testing %K drug checking %K qualitative %K interview %K interviews %K digital health %K digital technology %K digital intervention %K digital interventions %K technological intervention %K technological interventions %K technology-based intervention %K technology-based interventions %D 2024 %7 3.7.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Overdose deaths continue to reach new records in New York City and nationwide, largely driven by adulterants such as fentanyl and xylazine in the illicit drug supply. Unknowingly consuming adulterated substances dramatically increases risks of overdose and other health problems, especially when individuals consume multiple adulterants and are exposed to a combination of drugs they did not intend to take. Although test strips and more sophisticated devices enable people to check drugs for adulterants including fentanyl and xylazine prior to consumption and are often available free of charge, many people who use drugs decline to use them. Objective: We sought to better understand why people in the New York City area do or do not check drugs before use. We plan to use study findings to inform the development of technology-based interventions to encourage consistent drug checking. Methods: In summer 2023, team members who have experience working with people who use drugs conducted 22 semistructured qualitative interviews with a convenience sample of people who reported illicit drug use within the past 90 days. An interview guide examined participants’ knowledge of and experience with adulterants including fentanyl, xylazine, and benzodiazepines; using drug testing strips; and whether they had ever received harm reduction services. All interviews were audio recorded, transcribed, and analyzed for emerging themes. Results: Most participants lacked knowledge of adulterants, and only a few reported regularly checking drugs. Reasons for not checking included lacking convenient access to test supplies, or a place to check samples out of the public’s view, as well as time considerations. Some participants also reported a strong belief that they were not at risk from fentanyl, xylazine, or other adulterants because they exclusively used cocaine or crack, or that they were confident the people they bought drugs from would not sell them adulterated substances. Those who did report testing their drugs described positive interactions with harm reduction agency staff. Conclusions: New forms of outreach are needed not only to increase people’s knowledge of adulterated substances and awareness of the increasing risks they pose but also to encourage people who use drugs to regularly check their substances prior to use. This includes new intervention messages that highlight the importance of drug checking in the context of a rapidly changing and volatile drug supply. This messaging can potentially help normalize drug checking as an easily enacted behavior that benefits public health. To increase effectiveness, messages can be developed with, and outreach can be conducted by, trusted community members including people who use drugs and, potentially, people who sell drugs. Pairing this messaging with access to no-cost drug-checking supplies and equipment may help address the ongoing spiral of increased overdose deaths nationwide. %M 38959505 %R 10.2196/56755 %U https://formative.jmir.org/2024/1/e56755 %U https://doi.org/10.2196/56755 %U http://www.ncbi.nlm.nih.gov/pubmed/38959505 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e55280 %T Implementation of a Parent Training Program During Community-Based Dissemination (From In-Person to Hybrid): Mixed Methods Evaluation %A McGrane Minton,Heather %A Murray,Linda %A Allan,Marjorie J %A Perry,Roslyn %A Bettencourt,Amie F %A Gross,Deborah %A Strano,Lauri %A Breitenstein,Susan M %+ College of Nursing, The Ohio State University, 1577 Neil Ave., Columbus, OH, 43210, United States, 1 6146884614, breitenstein.5@osu.edu %K COVID-19 %K implementation %K internet-based intervention %K parenting %K community dissemination %K hybrid delivery %D 2024 %7 3.7.2024 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Parent training interventions support and strengthen parenting practices and parent-child relationships and improve child behavior. Between March 2018 and February 2020, a community-based parenting program conducted 38 in-person Chicago Parent Program (CPP) groups. In response to the COVID-19 pandemic, we modified the delivery of the in-person CPP to hybrid delivery using the self-administered, web-based version of the CPP (ezParent) paired with web-based, videoconferenced group sessions. Objective: This study aims to describe the delivery transition and implementation outcomes of the hybrid delivery of the CPP (ezParent+group) during community-based dissemination. Methods: This single-group, mixed methods retrospective evaluation examined the implementation outcomes using the RE-AIM (Reach, Efficacy, Adoption, Implementation, and Maintenance) framework. We report on data from hybrid ezParent delivery between September 2020 and August 2022. Parents completed pre- and postprogram surveys that included motivation to participate and perceived changes in parent-child behavior. Digital analytics captured ezParent completion. Facilitators completed fidelity assessments and participated in postintervention interviews. Results: In total, 24 hybrid ezParent groups (n=240 parents) were delivered by 13 CPP-trained facilitators. Parents reported high levels of satisfaction with the program and improvements in their feelings of parenting self-efficacy and their child’s behavior following their participation in hybrid ezParent. On average, parents completed 4.58 (SD 2.43) 6 ezParent modules. The average group attendance across the 4 sessions was 71.2%. Facilitators found the hybrid delivery easy to implement and reported high parent engagement and understanding of CPP strategies. Conclusions: Using the hybrid ezParent intervention is a feasible and effective way to engage parents. Lessons learned included the importance of academic and community-based organization partnerships for delivering and evaluating robust programs. Implementation facilitators and barriers and future research recommendations are discussed. %M 38959504 %R 10.2196/55280 %U https://pediatrics.jmir.org/2024/1/e55280 %U https://doi.org/10.2196/55280 %U http://www.ncbi.nlm.nih.gov/pubmed/38959504 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e56118 %T Motivational Variables as Moderating Effects of a Web-Based Mental Health Program for University Students: Secondary Analysis of a Randomized Controlled Trial %A Hanano,Maria %A Rith-Najarian,Leslie %A Gong-Guy,Elizabeth %A Chavira,Denise %+ University of California, Los Angeles, 405 Hilgard Ave, Los Angeles, CA, 90095, United States, 1 9493501523, mariahanano@g.ucla.edu %K web-based intervention %K internal motivation %K depression %K anxiety %K self-determination theory %K mental health %K university students %K university %K students %K web-based %K analysis %K randomized controlled trial %K self-guided %D 2024 %7 3.7.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Self-guided web-based interventions have the potential of addressing help-seeking barriers and symptoms common among university students, such as depression and anxiety. Unfortunately, self-guided interventions are also associated with less adherence, implicating motivation as a potential moderator for adherence and improvement for such interventions. Previous studies examining motivation as a moderator or predictor of improvement on web-based interventions have defined and measured motivation variably, producing conflicting results. Objective: This secondary analysis of data from a randomized controlled trial aimed to examine constructs of motivation as moderators of improvement for a self-guided 8-week web-based intervention in university students (N=1607). Methods: Tested moderators included internal motivation, external motivation, and confidence in treatment derived from the Treatment Motivation Questionnaire. The primary outcome was an improvement in depression and anxiety measured by the Depression Anxiety Stress Scale-21. Results: Piecewise linear mixed effects models showed that internal motivation significantly moderated symptom change for the intervention group (t1504=–2.94; P=.003) at average and high (+1 SD) motivation levels (t1507=–2.28; P=.02 and t1507=–4.05; P<.001, respectively). Significant results remained even after controlling for baseline severity. The results showed that confidence in treatment did not significantly moderate symptom change for the intervention group (t1504=1.44; P=.15). In this sample, only internal motivation was positively correlated with service initiation, intervention adherence, and intervention satisfaction. Conclusions: The combination of a web-based intervention and high or moderate internal motivation resulted in greater improvement in the total Depression Anxiety Stress Scale-21 score. These findings highlight the importance of conceptually differentiating motivation-related constructs when examining moderators of improvement. The results suggest that the combination of a web-based intervention and high or moderate internal motivation results in greater improvement. These findings highlight the importance of conceptually differentiating motivation-related constructs when examining moderators of improvement. To better understand the moderating role of internal motivation, future research is encouraged to replicate these findings in diverse samples as well as to examine related constructs such as baseline severity and adherence. Understanding these characteristics informs treatment strategies to maximize adherence and improvement when developing web-based interventions as well as allows services to be targeted to individuals likely to benefit from such interventions. Trial Registration: ClinicalTrials.gov NCT04361045; https://clinicaltrials.gov/study/NCT04361045 %M 38959024 %R 10.2196/56118 %U https://formative.jmir.org/2024/1/e56118 %U https://doi.org/10.2196/56118 %U http://www.ncbi.nlm.nih.gov/pubmed/38959024 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e55964 %T Human Factors in AI-Driven Digital Solutions for Increasing Physical Activity: Scoping Review %A Gabarron,Elia %A Larbi,Dillys %A Rivera-Romero,Octavio %A Denecke,Kerstin %+ Department of Education, ICT and Learning, Østfold University College, B R A Veien 4, Halden, 1757, Norway, 47 94863460, elia.gabarron@hiof.no %K machine learning %K ML %K artificial intelligence %K AI %K algorithm %K algorithms %K predictive model %K predictive models %K predictive analytics %K predictive system %K practical model %K practical models %K deep learning %K human factors %K physical activity %K physical exercise %K healthy living %K active lifestyle %K exercise %K physically active %K digital health %K mHealth %K mobile health %K app %K apps %K application %K applications %K digital health %K digital technology %K digital intervention %K digital interventions %K smartphone %K smartphones %K PRISMA %D 2024 %7 3.7.2024 %9 Review %J JMIR Hum Factors %G English %X Background: Artificial intelligence (AI) has the potential to enhance physical activity (PA) interventions. However, human factors (HFs) play a pivotal role in the successful integration of AI into mobile health (mHealth) solutions for promoting PA. Understanding and optimizing the interaction between individuals and AI-driven mHealth apps is essential for achieving the desired outcomes. Objective: This study aims to review and describe the current evidence on the HFs in AI-driven digital solutions for increasing PA. Methods: We conducted a scoping review by searching for publications containing terms related to PA, HFs, and AI in the titles and abstracts across 3 databases—PubMed, Embase, and IEEE Xplore—and Google Scholar. Studies were included if they were primary studies describing an AI-based solution aimed at increasing PA, and results from testing the solution were reported. Studies that did not meet these criteria were excluded. Additionally, we searched the references in the included articles for relevant research. The following data were extracted from included studies and incorporated into a qualitative synthesis: bibliographic information, study characteristics, population, intervention, comparison, outcomes, and AI-related information. The certainty of the evidence in the included studies was evaluated using GRADE (Grading of Recommendations Assessment, Development, and Evaluation). Results: A total of 15 studies published between 2015 and 2023 involving 899 participants aged approximately between 19 and 84 years, 60.7% (546/899) of whom were female participants, were included in this review. The interventions lasted between 2 and 26 weeks in the included studies. Recommender systems were the most commonly used AI technology in digital solutions for PA (10/15 studies), followed by conversational agents (4/15 studies). User acceptability and satisfaction were the HFs most frequently evaluated (5/15 studies each), followed by usability (4/15 studies). Regarding automated data collection for personalization and recommendation, most systems involved fitness trackers (5/15 studies). The certainty of the evidence analysis indicates moderate certainty of the effectiveness of AI-driven digital technologies in increasing PA (eg, number of steps, distance walked, or time spent on PA). Furthermore, AI-driven technology, particularly recommender systems, seems to positively influence changes in PA behavior, although with very low certainty evidence. Conclusions: Current research highlights the potential of AI-driven technologies to enhance PA, though the evidence remains limited. Longer-term studies are necessary to assess the sustained impact of AI-driven technologies on behavior change and habit formation. While AI-driven digital solutions for PA hold significant promise, further exploration into optimizing AI’s impact on PA and effectively integrating AI and HFs is crucial for broader benefits. Thus, the implications for innovation management involve conducting long-term studies, prioritizing diversity, ensuring research quality, focusing on user experience, and understanding the evolving role of AI in PA promotion. %M 38959064 %R 10.2196/55964 %U https://humanfactors.jmir.org/2024/1/e55964 %U https://doi.org/10.2196/55964 %U http://www.ncbi.nlm.nih.gov/pubmed/38959064 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e58549 %T A Digital Sexual Health Education Web Application for Resource-Poor Regions in Kenya: Implementation-Oriented Case Study Using the Intercultural Research Model %A Soehnchen,Clarissa %A Burmann,Anja %A Henningsen,Maike %A Meister,Sven %+ Health Informatics, School of Medicine, Faculty of Health, Witten/Herdecke University, Alfred-Herrhausen-Straße 50, Witten, 58455, Germany, 49 2302 9260, clarissa.soehnchen@uni-wh.de %K sexual health education %K Intercultural Research Model %K semistructured interview %K SUS analysis %K user-centered design %D 2024 %7 3.7.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Developing a digital educational application focused on sexual health education necessitates a framework that integrates cultural considerations effectively. Drawing from previous research, we identified the problem and essential requirements to incorporate cultural insights into the development of a solution. Objective: This study aims to explore the Solution Room of the self-established Intercultural Research Model, with a focus on creating a reusable framework for developing and implementing a widely accessible digital educational tool for sexual health. The study centers on advancing from a low-fidelity prototype (She!Masomo) to a high-fidelity prototype (We!Masomo), while evaluating its system usability through differentiation. This research contributes to the pursuit of Sustainable Development Goals 3, 4, and 5. Methods: The research methodology is anchored in the Solution Room of the self-expanded Intercultural Research Model, which integrates cultural considerations. It uses a multimethod, user-centered design thinking approach, focusing on extensive human involvement for the open web-based application. This includes gathering self-assessed textual user feedback, conducting a System Usability Scale (SUS) analysis, and conducting 4 face-to-face semistructured expert interviews, following COREQ (Consolidated Criteria for Reporting Qualitative Research) guidelines. Results: Based on the identified limitations of the low-fidelity prototype, She!Masomo (SUS score 67), which were highlighted through textual user feedback (63/77) and prototype feature comparisons, iterative development and improvement were implemented. This process led to the creation of an enhanced high-fidelity prototype (We!Masomo). The improved effectiveness of the enhanced prototype was evaluated using the qualitative SUS analysis (82/90), resulting in a favorable score of 77.3, compared with the previous SUS score of 67 for the low-fidelity prototype. Highlighting the importance of accessible digital educational tools, this study conducted 4 expert interviews (4/4) and reported e-survey results following the CHERRIES (Checklist for Reporting Results of Internet E-Surveys) guideline. The digital educational platform, We!Masomo, is specifically designed to promote universal and inclusive free access to information. Therefore, the developed high-fidelity prototype was implemented in Kenya. Conclusions: The primary outcome of this research provides a comprehensive exploration of utilizing a case study methodology to advance the development of digital educational web tools, particularly focusing on cultural sensitivity and sensitive educational subjects. It offers critical insights for effectively introducing such tools in regions with limited resources. Nonetheless, it is crucial to emphasize that the findings underscore the importance of integrating culture-specific components during the design phase. This highlights the necessity of conducting a thorough requirement engineering analysis and developing a low-fidelity prototype, followed by an SUS analysis. These measures are particularly critical when disseminating sensitive information, such as sexual health, through digital platforms. International Registered Report Identifier (IRRID): RR2-10.1186/s12905-023-02839-6 %M 38959047 %R 10.2196/58549 %U https://formative.jmir.org/2024/1/e58549 %U https://doi.org/10.2196/58549 %U http://www.ncbi.nlm.nih.gov/pubmed/38959047 %0 Journal Article %@ 2368-7959 %I %V 11 %N %P e56569 %T The Role of Humanization and Robustness of Large Language Models in Conversational Artificial Intelligence for Individuals With Depression: A Critical Analysis %A Ferrario,Andrea %A Sedlakova,Jana %A Trachsel,Manuel %K generative AI %K large language models %K large language model %K LLM %K LLMs %K machine learning %K ML %K natural language processing %K NLP %K deep learning %K depression %K mental health %K mental illness %K mental disease %K mental diseases %K mental illnesses %K artificial intelligence %K AI %K digital health %K digital technology %K digital intervention %K digital interventions %K ethics %D 2024 %7 2.7.2024 %9 %J JMIR Ment Health %G English %X Large language model (LLM)–powered services are gaining popularity in various applications due to their exceptional performance in many tasks, such as sentiment analysis and answering questions. Recently, research has been exploring their potential use in digital health contexts, particularly in the mental health domain. However, implementing LLM-enhanced conversational artificial intelligence (CAI) presents significant ethical, technical, and clinical challenges. In this viewpoint paper, we discuss 2 challenges that affect the use of LLM-enhanced CAI for individuals with mental health issues, focusing on the use case of patients with depression: the tendency to humanize LLM-enhanced CAI and their lack of contextualized robustness. Our approach is interdisciplinary, relying on considerations from philosophy, psychology, and computer science. We argue that the humanization of LLM-enhanced CAI hinges on the reflection of what it means to simulate “human-like” features with LLMs and what role these systems should play in interactions with humans. Further, ensuring the contextualization of the robustness of LLMs requires considering the specificities of language production in individuals with depression, as well as its evolution over time. Finally, we provide a series of recommendations to foster the responsible design and deployment of LLM-enhanced CAI for the therapeutic support of individuals with depression. %R 10.2196/56569 %U https://mental.jmir.org/2024/1/e56569 %U https://doi.org/10.2196/56569 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e55831 %T Digital Interventions to Modify Skin Cancer Risk Behaviors in a National Sample of Young Adults: Randomized Controlled Trial %A Heckman,Carolyn J %A Mitarotondo,Anna %A Lin,Yong %A Khavjou,Olga %A Riley,Mary %A Manne,Sharon L %A Yaroch,Amy L %A Niu,Zhaomeng %A Glanz,Karen %+ Rutgers Cancer Institute, 120 Albany St, New Brunswick, NJ, 08901, United States, 1 732 235 8830, ch842@rutgers.edu %K skin cancer prevention %K sun protection %K sun exposure %K digital intervention %K social media %K young adults %K sun %K skin cancer %K prevention %K cancer %K randomized controlled trial %K Facebook %K Instagram %K engagement %K behavior %K protection %K skin %K sunscreen %D 2024 %7 2.7.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Young adults engage in behaviors that place them at risk for skin cancer. Dissemination of digital health promotion interventions via social media is a potentially promising strategy to modify skin cancer risk behaviors by increasing UV radiation (UVR) protection and skin cancer examinations. Objective: This study aimed to compare 3 digital interventions designed to modify UVR exposure, sun protection, and skin cancer detection behaviors among young adults at moderate to high risk of skin cancer. Methods: This study was a hybrid type II effectiveness-implementation randomized controlled trial of 2 active interventions, a digital skin cancer risk reduction intervention (UV4.me [basic]) compared with an enhanced version (UV4.me2 [enhanced]), and an electronic pamphlet (e-pamphlet). Intervention effects were assessed over the course of a year among 1369 US young adults recruited primarily via Facebook and Instagram. Enhancements to encourage intervention engagement and behavior change included more comprehensive goal-setting activities, ongoing proactive messaging related to previously established mediators (eg, self-efficacy) of UVR exposure and protection, embedded incentives for module completion, and ongoing news and video updates. Primary outcome effects assessed via linear regression were UVR exposure and sun protection and protection habits. Secondary outcome effects assessed via logistic regression were skin self-exams, physician skin exams, sunscreen use, indoor tanning, and sunburn. Results: The active interventions increased sun protection (basic: P=.02; enhanced: P<.001) and habitual sun protection (basic: P=.04; enhanced P=.01) compared with the e-pamphlet. The enhanced intervention increased sun protection more than the basic one. Each active intervention increased sunscreen use at the 3-month follow-up (basic: P=.03; enhanced: P=.01) and skin self-exam at 1 year (basic: P=.04; enhanced: P=.004), compared with the e-pamphlet. Other intervention effects and differences between the Basic and Enhanced Intervention effects were nonsignificant. Conclusions: The active interventions were effective in improving several skin cancer risk and skin cancer prevention behaviors. Compared with the basic intervention, the enhanced intervention added to the improvement in sun protection but not other behaviors. Future analyses will explore intervention engagement (eg, proportion of content reviewed). Trial Registration: ClinicalTrials.gov NCT03313492; http://clinicaltrials.gov/ct2/show/NCT03313492 %M 38954433 %R 10.2196/55831 %U https://www.jmir.org/2024/1/e55831 %U https://doi.org/10.2196/55831 %U http://www.ncbi.nlm.nih.gov/pubmed/38954433 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e57863 %T The Effect of an mHealth Self-Monitoring Intervention (MI-BP) on Blood Pressure Among Black Individuals With Uncontrolled Hypertension: Randomized Controlled Trial %A Buis,Lorraine R %A Kim,Junhan %A Sen,Ananda %A Chen,Dongru %A Dawood,Katee %A Kadri,Reema %A Muladore,Rachelle %A Plegue,Melissa %A Richardson,Caroline R %A Djuric,Zora %A McNaughton,Candace %A Hutton,David %A Robert,Lionel P %A Park,Sun Young %A Levy,Phillip %+ Department of Family Medicine, University of Michigan, 1018 Fuller St., Ann Arbor, MI, 48104, United States, 1 734 998 7120, buisl@umich.edu %K blood pressure %K hypertension %K mobile health %K mHealth %K mobile phone %K smartphone %D 2024 %7 28.6.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Hypertension is one of the most important cardiovascular disease risk factors and affects >100 million American adults. Hypertension-related health inequities are abundant in Black communities as Black individuals are more likely to use the emergency department (ED) for chronic disease–related ambulatory care, which is strongly linked to lower blood pressure (BP) control, diminished awareness of hypertension, and adverse cardiovascular events. To reduce hypertension-related health disparities, we developed MI-BP, a culturally tailored multibehavior mobile health intervention that targeted behaviors of BP self-monitoring, physical activity, sodium intake, and medication adherence in Black individuals with uncontrolled hypertension recruited from ED and community-based settings. Objective: We sought to determine the effect of MI-BP on BP as well as secondary outcomes of physical activity, sodium intake, medication adherence, and BP control compared to enhanced usual care control at 1-year follow-up. Methods: We conducted a 1-year, 2-group randomized controlled trial of the MI-BP intervention compared to an enhanced usual care control group where participants aged 25 to 70 years received a BP cuff and hypertension-related educational materials. Participants were recruited from EDs and other community-based settings in Detroit, Michigan, where they were screened for initial eligibility and enrolled. Baseline data collection and randomization occurred approximately 2 and 4 weeks after enrollment to ensure that participants had uncontrolled hypertension and were willing to take part. Data collection visits occurred at 13, 26, 39, and 52 weeks. Outcomes of interest included BP (primary outcome) and physical activity, sodium intake, medication adherence, and BP control (secondary outcomes). Results: We obtained consent from and enrolled 869 participants in this study yet ultimately randomized 162 (18.6%) participants. At 1 year, compared to the baseline, both groups showed significant decreases in systolic BP (MI-BP group: 22.5 mm Hg decrease in average systolic BP and P<.001; control group: 24.1 mm Hg decrease and P<.001) adjusted for age and sex, with no significant differences between the groups (time-by-arm interaction: P=.99). Similar patterns where improvements were noted in both groups yet no differences were found between the groups were observed for diastolic BP, physical activity, sodium intake, medication adherence, and BP control. Large dropout rates were observed in both groups (approximately 60%). Conclusions: Overall, participants randomized to both the enhanced usual care control and MI-BP conditions experienced significant improvements in BP and other outcomes; however, differences between groups were not detected, speaking to the general benefit of proactive outreach and engagement focused on cardiometabolic risk reduction in urban-dwelling, low-socioeconomic-status Black populations. High dropout rates were found and are likely to be expected when working with similar populations. Future work is needed to better understand engagement with mobile health interventions, particularly in this population. Trial Registration: ClinicalTrials.gov NCT02955537; https://clinicaltrials.gov/study/NCT02955537 International Registered Report Identifier (IRRID): RR2-10.2196/12601 %R 10.2196/57863 %U https://mhealth.jmir.org/2024/1/e57863 %U https://doi.org/10.2196/57863 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e54892 %T A Digital Microintervention Supporting Evidence-Based Parenting Skills: Development Study Using the Agile Scrum Methodology %A Hodson,Nathan %A Woods,Peter %A Sobolev,Michael %A Giacco,Domenico %+ Price School of Public Policy, University of Southern California, 650 Childs Way, Los Angeles, CA, 90089, United States, 1 2133480086, nathan.hodson@warwick.ac.uk %K parenting %K child behavior %K mental health %K app development %K digital %D 2024 %7 28.6.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Conduct disorder increases risks of educational dropout, future mental illness, and incarceration if untreated. First-line treatment of conduct disorder involves evidence-based parenting skills programs. Time-outs, a frequent tool in these programs, can be effective at improving behavior, and recent apps have been developed to aid this process. However, these apps promote the use of time-outs in inconsistent or developmentally inappropriate ways, potentially worsening behavior problems. Digital microinterventions like these apps could guide parents through high-quality time-outs in the moment, but current time-out apps lack features promoting adherence to the evidence-based best practice. Agile scrum is a respected approach in the software development industry. Objective: We aimed to explore the feasibility of using the agile scrum approach to build a digital microintervention to help parents deliver an evidence-based time-out. Methods: The agile scrum methodology was used. Four sprints were conducted. Figma software was used for app design and wireframing. Insights from 42 expert stakeholders were used during 3 sprint reviews. We consulted experts who were identified from councils around the Midlands region of the United Kingdom and charities through personal contacts and a snowballing approach. Results: Over 4 development sprints from August 2022 to March 2023, the app was iteratively designed and refined based on consultation with a diverse group of 42 experts who shared their knowledge about the content of common parenting programs and the challenges parents commonly face. Modifications made throughout the process resulted in significant app enhancements, including tailored timer algorithms and enhanced readability, as well as an onboarding zone, mindfulness module, and pictorial information to increase inclusivity. By the end of the fourth sprint, the app was deemed ready for home use by stakeholders, demonstrating the effectiveness of our agile scrum development approach. Conclusions: We developed an app to support parents to use the evidence-based time-out technique. We recommend the agile scrum approach to create mobile health apps. Our experience highlights the valuable role that frontline health and social care professionals, particularly those working with vulnerable families, can play as experts in scrum reviews. There is a need for research to both evaluate the impact of digital microinterventions on child behavioral change and also create digital microinterventions that cater to non–English speakers and individuals who participate in parenting programs in settings outside the United Kingdom. %M 38941594 %R 10.2196/54892 %U https://formative.jmir.org/2024/1/e54892 %U https://doi.org/10.2196/54892 %U http://www.ncbi.nlm.nih.gov/pubmed/38941594 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 13 %N %P e44906 %T Intramural Health Care Through Video Consultations and the Need for Referrals and Hospital Admissions: Retrospective Quantitative Subanalysis of an Evaluation Study %A Schmalstieg-Bahr,Katharina %A Colombo,Miriam Giovanna %A Koch,Roland %A Szecsenyi,Joachim %A Völker,Friedrich %A Blozik,Eva Elisabeth %A Scherer,Martin %+ Department of General Practice and Primary Care, University Medical Center Eppendorf, Martinistrasse 52, Bldg. W37, 5th Fl, Hamburg, 20246, Germany, 49 40 7410 52400, k.schmalstieg-bahr@uke.de %K intramural health care %K prison %K telemedicine %K primary care %K family medicine %K referral %K hospital admission %K admission rate %K intramural %K penal %K video consult %K e-consult %K remote care %K virtual care %K health care delivery %K service delivery %K health care system %D 2024 %7 28.6.2024 %9 Original Paper %J Interact J Med Res %G English %X Background: In comparison to the general population, prison inmates are at a higher risk for drug abuse and psychiatric, as well as infectious, diseases. Although intramural health care has to be equivalent to extramural services, prison inmates have less access to primary and secondary care. Furthermore, not every prison is constantly staffed with a physician. Since transportation to the nearest extramural medical facility is often resource-intensive, video consultations may offer cost-effective health care for prison inmates. Objective: This study aims to quantify the need for referrals to secondary care services and hospital admissions when video consultations with family physicians and psychiatrists are offered in prison. Methods: In 5 German prisons, a mixed methods evaluation study was conducted to assess feasibility, acceptance, and reasons for conducting video consultations with family physicians and psychiatrists. This analysis uses quantitative data from these consultations (June 2018 to February 2019) in addition to data from a sixth prison added in January 2019 focusing on referral and admission rates, as well as reasons for encounters. Results: At the initiation of the project, 2499 prisoners were detained in the 6 prisons. A total of 435 video consultations were conducted by 12 physicians (3 female and 7 male family physicians, and 2 male psychiatrists during the study period). The majority were scheduled consultations (341/435, 78%). In 68% (n=294) of all encounters, the patient was asked to consult a physician again if symptoms persisted or got worse. In 26% (n=115), a follow-up appointment with either the video consultant or prison physician was scheduled. A referral to other specialties, most often psychiatry, was necessary in 4% (n=17) of the cases. Only in 2% (n=8) of the consultations, a hospital admission was needed. Usually, hospital admissions were the result of unscheduled consultations, and the videoconferencing system was the method of communication in 88% (n=7) of these cases, while 12% (n=1) were carried out over the phone. Reasons for admissions were severe abdominal pain, hypotension, unstable angina or suspected myocardial infarction, or a suspected schizophrenic episode. Conclusions: Most scheduled and unscheduled consultations did not require subsequent patient transport to external health care providers. Using telemedicine services allowed a prompt patient-physician encounter with the possibility to refer patients to other specialties or to admit them to a hospital if necessary. %M 38941595 %R 10.2196/44906 %U https://www.i-jmr.org/2024/1/e44906 %U https://doi.org/10.2196/44906 %U http://www.ncbi.nlm.nih.gov/pubmed/38941595 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e57699 %T mHealth-Based Just-in-Time Adaptive Intervention to Improve the Physical Activity Levels of Individuals With Spinal Cord Injury: Protocol for a Randomized Controlled Trial %A Carey,Rachel L %A Le,Ha %A Coffman,Donna L %A Nahum-Shani,Inbal %A Thirumalai,Mohanraj %A Hagen,Cole %A Baehr,Laura A %A Schmidt-Read,Mary %A Lamboy,Marlyn S R %A Kolakowsky-Hayner,Stephanie A %A Marino,Ralph J %A Intille,Stephen S %A Hiremath,Shivayogi V %+ Department of Health and Rehabilitation Sciences, Temple University, Pearson Hall 40, 1800 North Broad Street, Philadelphia, PA, 19121, United States, 1 215 204 0496, Shiv.Hiremath@temple.edu %K spinal cord injury %K physical activity %K just-in-time adaptive intervention %K mobile health %K randomized controlled trial %K microrandomized trial %K wearable sensors %K ecological momentary assessment %K community %K mobile phone %D 2024 %7 28.6.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The lack of regular physical activity (PA) in individuals with spinal cord injury (SCI) in the United States is an ongoing health crisis. Regular PA and exercise-based interventions have been linked with improved outcomes and healthier lifestyles among those with SCI. Providing people with an accurate estimate of their everyday PA level can promote PA. Furthermore, PA tracking can be combined with mobile health technology such as smartphones and smartwatches to provide a just-in-time adaptive intervention (JITAI) for individuals with SCI as they go about everyday life. A JITAI can prompt an individual to set a PA goal or provide feedback about their PA levels. Objective: The primary aim of this study is to investigate whether minutes of moderate-intensity PA among individuals with SCI can be increased by integrating a JITAI with a web-based PA intervention (WI) program. The WI program is a 14-week web-based PA program widely recommended for individuals with disabilities. A secondary aim is to investigate the benefit of a JITAI on proximal PA, defined as minutes of moderate-intensity PA within 120 minutes of a PA feedback prompt. Methods: Individuals with SCI (N=196) will be randomized to a WI arm or a WI+JITAI arm. Within the WI+JITAI arm, a microrandomized trial will be used to randomize participants several times a day to different tailored feedback and PA recommendations. Participants will take part in the 24-week study from their home environment in the community. The study has three phases: (1) baseline, (2) WI program with or without JITAI, and (3) PA sustainability. Participants will provide survey-based information at the initial meeting and at the end of weeks 2, 8, 16, and 24. Participants will be asked to wear a smartwatch every day for ≥12 hours for the duration of the study. Results: Recruitment and enrollment began in May 2023. Data analysis is expected to be completed within 6 months of finishing participant data collection. Conclusions: The JITAI has the potential to achieve long-term PA performance by delivering tailored, just-in-time feedback based on the person’s actual PA behavior rather than a generic PA recommendation. New insights from this study may guide intervention designers to develop engaging PA interventions for individuals with disability. Trial Registration: ClinicalTrials.gov NCT05317832; https://clinicaltrials.gov/study/NCT05317832 International Registered Report Identifier (IRRID): DERR1-10.2196/57699 %M 38941145 %R 10.2196/57699 %U https://www.researchprotocols.org/2024/1/e57699 %U https://doi.org/10.2196/57699 %U http://www.ncbi.nlm.nih.gov/pubmed/38941145 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56123 %T Effects of a Patient Portal Intervention to Address Diabetes Care Gaps: Protocol for a Pragmatic Randomized Controlled Trial %A Hackstadt,Amber J %A Elasy,Tom A %A Gangaputra,Sapna %A Harper,Kryseana J %A Mayberry,Lindsay S %A Nelson,Lyndsay A %A Peterson,Neeraja B %A Rosenbloom,S Trent %A Yu,Zhihong %A Martinez,William %+ Division of General Internal Medicine, Department of Medicine, Vanderbilt University Medical Center, 2525 West End Avenue, Suite 450, Nashville, TN, 37203, United States, 1 615 322 5000, william.martinez@vumc.org %K patient portals %K self-management %K self-efficacy %K diabetes mellitus %K health literacy %K attitudes %D 2024 %7 28.6.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite the potential to significantly reduce complications, many patients do not consistently receive diabetes preventive care. Our research team recently applied user-centered design sprint methodology to develop a patient portal intervention empowering patients to address selected diabetes care gaps (eg, no diabetes eye examination in last 12 months). Objective: This study aims to evaluate the effect of our novel diabetes care gap intervention on completion of selected evidence-based diabetes preventive care services and secondary outcomes. Methods: We are conducting a pragmatic randomized controlled trial of the effect of the intervention on diabetes care gaps. Adult patients with diabetes mellitus (DM) are recruited from primary care clinics affiliated with Vanderbilt University Medical Center. Participants are eligible if they have type 1 or 2 DM, can read in English, are aged 18-75 years, have a current patient portal account, and have reliable access to a mobile device with internet access. We exclude patients with medical conditions that prevent them from using a mobile device, severe difficulty seeing, pregnant women or women who plan to become pregnant during the study period, and patients on dialysis. Participants will be randomly assigned to the intervention or usual care. The primary outcome measure will be the number of diabetes care gaps among 4 DM preventive care services (diabetes eye examination, pneumococcal vaccination, hemoglobin A1c, and urine microalbumin) at 12 months after randomization. Secondary outcomes will include diabetes self-efficacy, confidence managing diabetes in general, understanding of diabetes preventive care, diabetes distress, patient portal satisfaction, and patient-initiated orders at baseline, 3 months, 6 months, and 12 months after randomization. An ordinal logistic regression model will be used to quantify the effect of the intervention on the number of diabetes care gaps at the 12-month follow-up. For dichotomous secondary outcomes, a logistic regression model will be used with random effects for the clinic and provider variables as needed. For continuous secondary outcomes, a regression model will be used. Results: This study is ongoing. Recruitment was closed in February 2022; a total of 433 patients were randomized. Of those randomized, most (n=288, 66.5%) were non-Hispanic White, 33.5% (n=145) were racial or ethnic minorities, 33.9% (n=147) were aged 65 years or older, and 30.7% (n=133) indicated limited health literacy. Conclusions: The study directly tests the hypothesis that a patient portal intervention—alerting patients about selected diabetes care gaps, fostering understanding of their significance, and allowing patients to initiate care—will reduce diabetes care gaps compared with usual care. The insights gained from this study may have broad implications for developing future interventions to address various care gaps, such as gaps in cancer screening, and contribute to the development of effective, scalable, and sustainable approaches to engage patients in chronic disease management and prevention. Trial Registration: ClinicalTrials.gov NCT04894903; https://classic.clinicaltrials.gov/ct2/show/NCT04894903 International Registered Report Identifier (IRRID): DERR1-10.2196/56123 %M 38941148 %R 10.2196/56123 %U https://www.researchprotocols.org/2024/1/e56123 %U https://doi.org/10.2196/56123 %U http://www.ncbi.nlm.nih.gov/pubmed/38941148 %0 Journal Article %@ 2368-7959 %I JMIR Mental Health %V 11 %N %P e50535 %T The Efficacy of Web-Based Cognitive Behavioral Therapy With a Shame-Specific Intervention for Social Anxiety Disorder: Randomized Controlled Trial %A Wen,Xu %A Gou,Mengke %A Chen,Huijing %A Kishimoto,Tomoko %A Qian,Mingyi %A Margraf,Jürgen %A Berger,Thomas %K social anxiety disorder %K web-based cognitive behavioral therapy %K shame intervention %K mediating effects %K shame experience %D 2024 %7 27.6.2024 %9 %J JMIR Ment Health %G English %X Background: Social anxiety disorder (SAD) is one of the most prevalent psychological disorders and generally co-occurs with elevated shame levels. Previous shame-specific interventions could significantly improve outcomes in social anxiety treatments. Recent review suggests that integrating a more direct shame intervention could potentially increase the effectiveness of cognitive behavioral therapy. Web-based cognitive behavioral therapy (WCBT) has proven efficacy, sustaining benefits for 6 months to 4 years. Previous evidence indicated that shame predicted the reduction of social anxiety and mediated between engagements in exposure and changes in social anxiety during WCBT. Objective: This study aimed to design a shame intervention component through a longitudinal study and conduct a randomized controlled trial to investigate the effectiveness of a shame intervention component in reducing social anxiety symptoms and shame experience in a clinical sample of people with SAD. Methods: The development of a shame intervention component was informed by cognitive behavioral principles and insights from longitudinal data that measured the Experience of Shame Scale (ESS), the Coping Styles Questionnaire, and the Social Interaction Anxiety Scale (SIAS) in 153 participants. The psychoeducation, cognitive construct, and exposure sections were tailored to focus more on shame-related problem-solving and self-blame. A total of 1220 participants were recruited to complete questionnaires, including the ESS, the SIAS, the Social Phobia Scale (SPS), and diagnostic interviews. Following a 2-round screening process, 201 participants with SAD were randomly assigned into a shame WCBT group, a normal WCBT group, and a waiting group. After the 8-week WCBT intervention, the participants were asked to complete posttest evaluations, including the ESS, SIAS and SPS. Results: Participants in the shame WCBT group experienced significant reductions in shame levels after the intervention (ESS: P<.001; ηp2=0.22), and the reduction was greater in the shame intervention group compared to normal WCBT (P<.001; mean deviation −12.50). Participants in both the shame WCBT and normal WCBT groups experienced significant reductions in social anxiety symptoms (SIAS: P<.001; ηp2=0.32; SPS: P<.001; ηp2=0.19) compared to the waiting group after intervention. Furthermore, in the experience of social interaction anxiety (SIAS), the shame WCBT group showed a higher reduction compared to the normal WCBT group (P<.001; mean deviation −9.58). Problem-solving (SE 0.049, 95% CI 0.025-0.217) and self-blame (SE 0.082, 95% CI 0.024-0.339) mediated the effect between ESS and SIAS. Conclusions: This is the first study to design and incorporate a shame intervention component in WCBT and to validate its efficacy via a randomized controlled trial. The shame WCBT group showed a significant reduction in both shame and social anxiety after treatment compared to the normal WCBT and waiting groups. Problem-solving and self-blame mediated the effect of shame on social anxiety. In conclusion, this study supports previous findings that a direct shame-specific intervention component could enhance the efficacy of WCBT. Trial Registration: Chinese Clinical Trial Registry ChiCTR2300072184; https://www.chictr.org.cn/showproj.html?proj=152757 %R 10.2196/50535 %U https://mental.jmir.org/2024/1/e50535 %U https://doi.org/10.2196/50535 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e54634 %T Long-Term Efficacy of a Mobile Mental Wellness Program: Prospective Single-Arm Study %A McCallum,Meaghan %A Baldwin,Matthew %A Thompson,Paige %A Blessing,Kelly %A Frisch,Maria %A Ho,Annabell %A Ainsworth,Matthew Cole %A Mitchell,Ellen Siobhan %A Michaelides,Andreas %A May,Christine N %+ Academic Research, Noom, Inc, 450 West 33rd Street, New York City, NY, 10001, United States, 1 8882665071, meaghanm@noom.com %K mHealth %K psychological distress %K Noom Mood %K digital mental wellness programs %K mobile phone %D 2024 %7 27.6.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Rising rates of psychological distress (symptoms of depression, anxiety, and stress) among adults in the United States necessitate effective mental wellness interventions. Despite the prevalence of smartphone app–based programs, research on their efficacy is limited, with only 14% showing clinically validated evidence. Our study evaluates Noom Mood, a commercially available smartphone-based app that uses cognitive behavioral therapy and mindfulness-based programming. In this study, we address gaps in the existing literature by examining postintervention outcomes and the broader impact on mental wellness. Objective: Noom Mood is a smartphone-based mental wellness program designed to be used by the general population. This prospective study evaluates the efficacy and postintervention outcomes of Noom Mood. We aim to address the rising psychological distress among adults in the United States. Methods: A 1-arm study design was used, with participants having access to the Noom Mood program for 16 weeks (N=273). Surveys were conducted at baseline, week 4, week 8, week 12, week 16, and week 32 (16 weeks’ postprogram follow-up). This study assessed a range of mental health outcomes, including anxiety symptoms, depressive symptoms, perceived stress, well-being, quality of life, coping, emotion regulation, sleep, and workplace productivity (absenteeism or presenteeism). Results: The mean age of participants was 40.5 (SD 11.7) years. Statistically significant improvements in anxiety symptoms, depressive symptoms, and perceived stress were observed by week 4 and maintained through the 16-week intervention and the 32-week follow-up. The largest changes were observed in the first 4 weeks (29% lower, 25% lower, and 15% lower for anxiety symptoms, depressive symptoms, and perceived stress, respectively), and only small improvements were observed afterward. Reductions in clinically relevant anxiety (7-item generalized anxiety disorder scale) and depression (8-item Patient Health Questionnaire depression scale) criteria were also maintained from program initiation through the 16-week intervention and the 32-week follow-up. Work productivity also showed statistically significant results, with participants gaining 2.57 productive work days from baseline at 16 weeks, and remaining relatively stable (2.23 productive work days gained) at follow-up (32 weeks). Additionally, effects across all coping, sleep disturbance (23% lower at 32 weeks), and emotion dysregulation variables exhibited positive and significant trends at all time points (15% higher, 23% lower, and 25% higher respectively at 32 weeks). Conclusions: This study contributes insights into the promising positive impact of Noom Mood on mental health and well-being outcomes, extending beyond the intervention phase. Though more rigorous studies are necessary to understand the mechanism of action at play, this exploratory study addresses critical gaps in the literature, highlighting the potential of smartphone-based mental wellness programs to lessen barriers to mental health support and improve diverse dimensions of well-being. Future research should explore the scalability, feasibility, and long-term adherence of such interventions across diverse populations. %M 38935946 %R 10.2196/54634 %U https://mhealth.jmir.org/2024/1/e54634 %U https://doi.org/10.2196/54634 %U http://www.ncbi.nlm.nih.gov/pubmed/38935946 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e58551 %T Real-World Evidence From a Digital Health Treatment Program for Female Urinary Incontinence: Observational Study of Outcomes Following User-Centered Product Design %A Hall,Evelyn %A Keyser,Laura %A McKinney,Jessica %A Pulliam,Samantha %A Weinstein,Milena %+ Department of Physical Therapy and Rehabilitation Science, University of California, San Francisco, 1500 Owens Street, Ste 400, San Francisco, CA, 94158, United States, 1 866 657 5382, laura.keyser@ucsf.edu %K urinary incontinence %K digital health %K pelvic floor muscle training %K real-world %K evidence %K user-centered design %K mobile phone %D 2024 %7 27.6.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Urinary incontinence (UI) affects millions of women with substantial health and quality-of-life impacts. Supervised pelvic floor muscle training (PFMT) is the recommended first-line treatment. However, multiple individual and institutional barriers impede women’s access to skilled care. Evidence suggests that digital health solutions are acceptable and may be effective in delivering first-line incontinence treatment, although these technologies have not yet been leveraged at scale. Objective: The primary objective is to describe the effectiveness and safety of a prescribed digital health treatment program to guide PFMT for UI treatment among real-world users. The secondary objectives are to evaluate patient engagement following an updated user platform and identify the factors predictive of success. Methods: This retrospective cohort study of women who initiated device use between January 1, 2022, and June 30, 2023, included users aged ≥18 years old with a diagnosis of stress, urgency, or mixed incontinence or a score of >33.3 points on the Urogenital Distress Inventory Short Form (UDI-6). Users are prescribed a 2.5-minute, twice-daily, training program guided by an intravaginal, motion-based device that pairs with a smartphone app. Data collected by the device or app include patient-reported demographics and outcomes, adherence to the twice-daily regimen, and pelvic floor muscle performance parameters, including angle change and hold time. Symptom improvement was assessed by the UDI-6 score change from baseline to the most recent score using paired 2-tailed t tests. Factors associated with meeting the UDI-6 minimum clinically important difference were evaluated by regression analysis. Results: Of 1419 users, 947 met inclusion criteria and provided data for analysis. The mean baseline UDI-6 score was 46.8 (SD 19.3), and the mean UDI-6 score change was 11.3 (SD 19.9; P<.001). Improvement was reported by 74% (697/947) and was similar across age, BMI, and incontinence subtype. Mean adherence was 89% (mean 12.5, SD 2.1 of 14 possible weekly uses) over 12 weeks. Those who used the device ≥10 times per week were more likely to achieve symptom improvement. In multivariate logistic regression analysis, baseline incontinence symptom severity and maximum angle change during pelvic floor muscle contraction were significantly associated with meeting the UDI-6 minimum clinically important difference. Age, BMI, and UI subtype were not associated. Conclusions: This study provides real-world evidence to support the effectiveness and safety of a prescribed digital health treatment program for female UI. A digital PFMT program completed with visual guidance from a motion-based device yields significant results when executed ≥10 times per week over a period of 12 weeks. The program demonstrates high user engagement, with 92.9% (880/947) of users adhering to the prescribed training regimen. First-line incontinence treatment, when implemented using this digital program, leads to statistically and clinically substantial symptom improvements across age and BMI categories and incontinence subtypes. %R 10.2196/58551 %U https://formative.jmir.org/2024/1/e58551 %U https://doi.org/10.2196/58551 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e58157 %T A Symptom-Checker for Adult Patients Visiting an Interdisciplinary Emergency Care Center and the Safety of Patient Self-Triage: Real-Life Prospective Evaluation %A Meer,Andreas %A Rahm,Philipp %A Schwendinger,Markus %A Vock,Michael %A Grunder,Bettina %A Demurtas,Jacopo %A Rutishauser,Jonas %+ In4medicine Inc, Monbijoustrasse 23, Bern, 3011, Switzerland, 41 313701330, a.meer@in4medicine.ch %K safety %K telemedicine %K teletriage %K symptom-checker %K self-triage %K self-assessment %K triage %K triaging %K symptom %K symptoms %K validation %K validity %K telehealth %K mHealth %K mobile health %K app %K apps %K application %K applications %K diagnosis %K diagnoses %K diagnostic %K diagnostics %K checker %K checkers %K check %K web %K neural network %K neural networks %D 2024 %7 27.6.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Symptom-checkers have become important tools for self-triage, assisting patients to determine the urgency of medical care. To be safe and effective, these tools must be validated, particularly to avoid potentially hazardous undertriage without leading to inefficient overtriage. Only limited safety data from studies including small sample sizes have been available so far. Objective: The objective of our study was to prospectively investigate the safety of patients’ self-triage in a large patient sample. We used SMASS (Swiss Medical Assessment System; in4medicine, Inc) pathfinder, a symptom-checker based on a computerized transparent neural network. Methods: We recruited 2543 patients into this single-center, prospective clinical trial conducted at the cantonal hospital of Baden, Switzerland. Patients with an Emergency Severity Index of 1-2 were treated by the team of the emergency department, while those with an index of 3-5 were seen at the walk-in clinic by general physicians. We compared the triage recommendation obtained by the patients’ self-triage with the assessment of clinical urgency made by 3 successive interdisciplinary panels of physicians (panels A, B, and C). Using the Clopper-Pearson CI, we assumed that to confirm the symptom-checkers’ safety, the upper confidence bound for the probability of a potentially hazardous undertriage should lie below 1%. A potentially hazardous undertriage was defined as a triage in which either all (consensus criterion) or the majority (majority criterion) of the experts of the last panel (panel C) rated the triage of the symptom-checker to be “rather likely” or “likely” life-threatening or harmful. Results: Of the 2543 patients, 1227 (48.25%) were female and 1316 (51.75%) male. None of the patients reached the prespecified consensus criterion for a potentially hazardous undertriage. This resulted in an upper 95% confidence bound of 0.1184%. Further, 4 cases met the majority criterion. This resulted in an upper 95% confidence bound for the probability of a potentially hazardous undertriage of 0.3616%. The 2-sided 95% Clopper-Pearson CI for the probability of overtriage (n=450 cases,17.69%) was 16.23% to 19.24%, which is considerably lower than the figures reported in the literature. Conclusions: The symptom-checker proved to be a safe triage tool, avoiding potentially hazardous undertriage in a real-life clinical setting of emergency consultations at a walk-in clinic or emergency department without causing undesirable overtriage. Our data suggest the symptom-checker may be safely used in clinical routine. Trial Registration: ClinicalTrials.gov NCT04055298; https://clinicaltrials.gov/study/NCT04055298 %M 38809606 %R 10.2196/58157 %U https://www.jmir.org/2024/1/e58157 %U https://doi.org/10.2196/58157 %U http://www.ncbi.nlm.nih.gov/pubmed/38809606 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e55747 %T Insights Derived From Text-Based Digital Media, in Relation to Mental Health and Suicide Prevention, Using Data Analysis and Machine Learning: Systematic Review %A Sweeney,Colm %A Ennis,Edel %A Mulvenna,Maurice D %A Bond,Raymond %A O'Neill,Siobhan %+ Department of Psychlogy, Ulster University, Cromore Rd, Coleraine, BT52 1SA, United Kingdom, 44 02870 123 456, Sweeney-C23@ulster.ac.uk %K mental health %K machine learning %K text analysis %K digital intervention %D 2024 %7 27.6.2024 %9 Review %J JMIR Ment Health %G English %X Background: Text-based digital media platforms have revolutionized communication and information sharing, providing valuable access to knowledge and understanding in the fields of mental health and suicide prevention. Objective: This systematic review aimed to determine how machine learning and data analysis can be applied to text-based digital media data to understand mental health and aid suicide prevention. Methods: A systematic review of research papers from the following major electronic databases was conducted: Web of Science, MEDLINE, Embase (via MEDLINE), and PsycINFO (via MEDLINE). The database search was supplemented by a hand search using Google Scholar. Results: Overall, 19 studies were included, with five major themes as to how data analysis and machine learning techniques could be applied: (1) as predictors of personal mental health, (2) to understand how personal mental health and suicidal behavior are communicated, (3) to detect mental disorders and suicidal risk, (4) to identify help seeking for mental health difficulties, and (5) to determine the efficacy of interventions to support mental well-being. Conclusions: Our findings show that data analysis and machine learning can be used to gain valuable insights, such as the following: web-based conversations relating to depression vary among different ethnic groups, teenagers engage in a web-based conversation about suicide more often than adults, and people seeking support in web-based mental health communities feel better after receiving online support. Digital tools and mental health apps are being used successfully to manage mental health, particularly through the COVID-19 epidemic, during which analysis has revealed that there was increased anxiety and depression, and web-based communities played a part in reducing isolation during the pandemic. Predictive analytics were also shown to have potential, and virtual reality shows promising results in the delivery of preventive or curative care. Future research efforts could center on optimizing algorithms to enhance the potential of text-based digital media analysis in mental health and suicide prevention. In addressing depression, a crucial step involves identifying the factors that contribute to happiness and using machine learning to forecast these sources of happiness. This could extend to understanding how various activities result in improved happiness across different socioeconomic groups. Using insights gathered from such data analysis and machine learning, there is an opportunity to craft digital interventions, such as chatbots, designed to provide support and address mental health challenges and suicide prevention. %M 38935419 %R 10.2196/55747 %U https://mental.jmir.org/2024/1/e55747 %U https://doi.org/10.2196/55747 %U http://www.ncbi.nlm.nih.gov/pubmed/38935419 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e54945 %T A Chatbot-Delivered Stress Management Coaching for Students (MISHA App): Pilot Randomized Controlled Trial %A Ulrich,Sandra %A Lienhard,Natascha %A Künzli,Hansjörg %A Kowatsch,Tobias %+ School of Applied Psychology, Zurich University of Applied Sciences, Pfingstweidstrasse 96, Zurich, 8005, Switzerland, 41 58 934 ext 8451, sandra.ulrich@zhaw.ch %K conversational agent %K mobile health %K mHealth %K smartphone %K stress management %K lifestyle %K behavior change %K coaching %K mobile phone %D 2024 %7 26.6.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Globally, students face increasing mental health challenges, including elevated stress levels and declining well-being, leading to academic performance issues and mental health disorders. However, due to stigma and symptom underestimation, students rarely seek effective stress management solutions. Conversational agents in the health sector have shown promise in reducing stress, depression, and anxiety. Nevertheless, research on their effectiveness for students with stress remains limited. Objective: This study aims to develop a conversational agent–delivered stress management coaching intervention for students called MISHA and to evaluate its effectiveness, engagement, and acceptance. Methods: In an unblinded randomized controlled trial, Swiss students experiencing stress were recruited on the web. Using a 1:1 randomization ratio, participants (N=140) were allocated to either the intervention or waitlist control group. Treatment effectiveness on changes in the primary outcome, that is, perceived stress, and secondary outcomes, including depression, anxiety, psychosomatic symptoms, and active coping, were self-assessed and evaluated using ANOVA for repeated measure and general estimating equations. Results: The per-protocol analysis revealed evidence for improvement of stress, depression, and somatic symptoms with medium effect sizes (Cohen d=−0.36 to Cohen d=−0.60), while anxiety and active coping did not change (Cohen d=−0.29 and Cohen d=0.13). In the intention-to-treat analysis, similar results were found, indicating reduced stress (β estimate=−0.13, 95% CI −0.20 to −0.05; P<.001), depressive symptoms (β estimate=−0.23, 95% CI −0.38 to −0.08; P=.003), and psychosomatic symptoms (β estimate=−0.16, 95% CI −0.27 to −0.06; P=.003), while anxiety and active coping did not change. Overall, 60% (42/70) of the participants in the intervention group completed the coaching by completing the postintervention survey. They particularly appreciated the quality, quantity, credibility, and visual representation of information. While individual customization was rated the lowest, the target group fitting was perceived as high. Conclusions: Findings indicate that MISHA is feasible, acceptable, and effective in reducing perceived stress among students in Switzerland. Future research is needed with different populations, for example, in students with high stress levels or compared to active controls. Trial Registration: German Clinical Trials Register DRKS 00030004; https://drks.de/search/en/trial/DRKS00030004 %M 38922677 %R 10.2196/54945 %U https://mhealth.jmir.org/2024/1/e54945 %U https://doi.org/10.2196/54945 %U http://www.ncbi.nlm.nih.gov/pubmed/38922677 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e55722 %T Applying Meaning and Self-Determination Theory to the Development of a Web-Based mHealth Physical Activity Intervention: Proof-of-Concept Pilot Study %A Hooker,Stephanie A %A Crain,A Lauren %A Muegge,Jule %A Rossom,Rebecca C %A Pronk,Nicolaas P %A Pasumarthi,Dhavan Prasad %A Kunisetty,Gopikrishna %A Masters,Kevin S %+ Division of Research and Evaluation, HealthPartners Institute, 8170 33rd Ave S MS21112R, Minneapolis, MN, 55425, United States, 1 9529675056, stephanie.a.hooker@healthpartners.com %K physical activity %K midlife %K digital health %K SMS text messaging %K theory-based %K meaning in life %K mobile phone %D 2024 %7 25.6.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Meaning in life is positively associated with health, well-being, and longevity, which may be partially explained by engagement in healthier behaviors, including physical activity (PA). However, promoting awareness of meaning is a behavior change strategy that has not been tested in previous PA interventions. Objective: This study aims to develop, refine, and pilot-test the Meaningful Activity Program (MAP; MAP to Health), a web-based mobile health PA intervention, theoretically grounded in meaning and self-determination theory, for insufficiently active middle-aged adults. Methods: Following an iterative user-testing and refinement phase, we used a single-arm double baseline proof-of-concept pilot trial design. Participants included 35 insufficiently active adults in midlife (aged 40-64 years) interested in increasing their PA. After a 4-week baseline period, participants engaged in MAP to Health for 8 weeks. MAP to Health used a web-based assessment and just-in-time SMS text messaging to individualize the intervention; promote meaning salience; support the basic psychological needs of autonomy, competence, and relatedness; and increase PA. Participants completed measures of the hypothesized mechanisms of behavior change, including meaning salience, needs satisfaction, and autonomous motivation at pretest (−4 weeks), baseline (0 weeks), midpoint (4 weeks), and posttest (8 weeks) time points, and wore accelerometers for the study duration. At the end of the intervention, participants completed a qualitative interview. Mixed models compared changes in behavioral mechanisms during the intervention to changes before the intervention. Framework matrix analyses were used to analyze qualitative data. Results: Participants were aged 50.8 (SD 8.2) years on average; predominantly female (27/35, 77%); and 20% (7/35) Asian, 9% (3/35) Black or African American, 66% (23/35) White, and 6% (2/35) other race. Most (32/35, 91%) used MAP to Health for ≥5 of 8 weeks. Participants rated the intervention as easy to use (mean 4.3, SD 0.8 [out of 5.0]) and useful (mean 4.3, SD 0.6). None of the hypothesized mechanisms changed significantly during the preintervention phase (Cohen d values <0.15). However, autonomy (P<.001; Cohen d=0.76), competence (P<.001; Cohen d=0.65), relatedness (P=.004; Cohen d=0.46), autonomous motivation (P<.001; Cohen d=0.37), and meaning salience (P<.001; Cohen d=0.40) increased significantly during the intervention. Comparison of slopes before the intervention versus during the intervention revealed that increases during the intervention were significantly greater for autonomy (P=.002), competence (P<.001), and meaning salience (P=.001); however, slopes were not significantly different for relatedness (P=.10) and autonomous motivation (P=.17). Qualitative themes offered suggestions for improvement. Conclusions: MAP to Health was acceptable to participants, feasible to deliver, and associated with increases in the target mechanisms of behavior change. This is the first intervention to use meaning as a behavior change strategy in a PA intervention. Future research will test the efficacy of the intervention in increasing PA compared to a control condition. %M 38917457 %R 10.2196/55722 %U https://formative.jmir.org/2024/1/e55722 %U https://doi.org/10.2196/55722 %U http://www.ncbi.nlm.nih.gov/pubmed/38917457 %0 Journal Article %@ 2291-9279 %I %V 12 %N %P e52231 %T Impact of Fruit and Vegetable Enzyme Supplementation on Aerobic Performance and Lactate Response in Older Adults Following High-Intensity Interval Exercise Through Exergaming: Randomized Experimental Matched-Pair Study %A Lin,Shu-Cheng %A Wang,Chien-Yen %A Hou,Tien-Hung %A Chen,Hong-Ching %A Wang,Chia-Chi %K Ring Fit Adventure %K training load %K older adult training %K training impulse %K food supplement %K older adults %K exergames %K exergame %K Taiwan %K female %K fruits %K vegetables %K blood lactate %K exercise %K feasibility %K aerobic %K enzymes %K enzyme %K female older adults %K fitness %K food intake %K diet %K exergaming %K enzyme supplements %K older adults training %K female older adult %K older adult %D 2024 %7 25.6.2024 %9 %J JMIR Serious Games %G English %X Background: Exercise offers substantial health benefits but can induce oxidative stress and inflammation, especially in high-intensity formats such as high-intensity interval exercise (HIIE). Exergaming has become an effective, enjoyable fitness tool for all ages, particularly older adults. Enzyme supplements may enhance exercise performance by improving lactate metabolism and reducing oxidative stress. Objective: This study investigates the efficacy of fruit and vegetable enzyme supplementation in modulating fatigue and enhancing aerobic capacity in older adults following HIIE through exergaming. Methods: The study recruited 16 older adult female participants and allocated them into 2 distinct groups (enzyme and placebo) based on their pretest lactate levels. This division used pairwise grouping to guarantee comparability between the groups, ensuring the integrity of the results. They engaged in HIIE using Nintendo Switch Ring Fit Adventure, performing 8 sets of 20 seconds of maximum effort exercise interspersed with 30 seconds of rest, totaling 370 seconds of exercise. Key metrics assessed included blood lactate levels, heart rate, rating of perceived exertion, and training impulse. Participants in the enzyme group were administered a fruit and vegetable enzyme supplement at a dosage of 30 mL twice daily over a period of 14 days. Results: The enzyme group showed significantly lower blood lactate levels compared to the placebo group, notably after the fourth (mean 4.29, SD 0.67 vs mean 6.34, SD 1.17 mmol/L; P=.001) and eighth (mean 5.84, SD 0.63 vs mean 8.20, SD 1.15 mmol/L; P<.001) exercise sessions. This trend continued at 5 minutes (mean 6.85, SD 0.82 vs mean 8.60, SD 1.13 mmol/L; P=.003) and 10 minutes (mean 5.91, SD 1.16 vs mean 8.21, SD 1.27 mmol/L; P=.002) after exercise. Although both groups exceeded 85% of their estimated maximum heart rate during the exercise, enzyme supplementation did not markedly affect the perceived intensity or effort. Conclusions: The study indicates that fruit and vegetable enzyme supplementation can significantly reduce blood lactate levels in older adults following HIIE through exergaming. This suggests a potential role for these enzymes in modulating lactate production or clearance during and after high-intensity exercise. These findings have implications for developing targeted interventions to enhance exercise tolerance and recovery in older adults. Trial Registration: ClinicalTrials.gov NCT06466408; https://clinicaltrials.gov/study/NCT06466408 %R 10.2196/52231 %U https://games.jmir.org/2024/1/e52231 %U https://doi.org/10.2196/52231 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 9 %N %P e55201 %T Inequalities in the Ability for People With Type 2 Diabetes and Prediabetes to Adapt to the Reduction in In-Person Health Support and Increased Use of Digital Support During the COVID-19 Pandemic and Beyond: Qualitative Study %A Turnbull,Sophie %A Cabral,Christie %+ Bristol Medical School, Population Health Sciences, University of Bristol, 5 Tyndall Avenue Bristol, Bristol, BS8 1UD, United Kingdom, 44 117 455 8613, sophie.turnbull@bristol.ac.uk %K diabetes %K diabetic %K DM %K diabetes mellitus %K type 2 diabetes %K type 1 diabetes %K prediabetes %K prediabetic %K COVID-19 pandemic %K COVID-19 %K SARS-CoV-2 %K coronavirus %K severe acute respiratory syndrome %K coronavirus infections %K novel coronavirus %K motivation %K health inequalities %K self-care %K mHealth %K mobile health %K app %K apps %K application %K applications %K digital health %K digital intervention %K digital interventions %K telemedicine %K telehealth %K virtual care %K virtual health %K virtual medicine %K remote consultation %K telephone consultation %K video consultation %K remote consultations %K telephone consultations %K video consultations %D 2024 %7 25.6.2024 %9 Original Paper %J JMIR Diabetes %G English %X Background: The COVID-19 pandemic created unprecedented challenges for people with type 2 diabetes (T2D) and prediabetes to access in-person health care support. Primary care teams accelerated plans to implement digital health technologies (DHTs), such as remote consultations and digital self-management. There is limited evidence about whether there were inequalities in how people with T2D and prediabetes adjusted to these changes. Objective: This study aimed to explore how people with T2D and prediabetes adapted to the reduction in in-person health support and the increased provision of support through DHTs during the COVID-19 pandemic and beyond. Methods: A purposive sample of people with T2D and prediabetes was recruited by text message from primary care practices that served low-income areas. Semistructured interviews were conducted by phone or video call, and data were analyzed thematically using a hybrid inductive and deductive approach. Results: A diverse sample of 30 participants was interviewed. There was a feeling that primary care had become harder to access. Participants responded to the challenge of accessing support by rationing or delaying seeking support or by proactively requesting appointments. Barriers to accessing health care support were associated with issues with using the total triage system, a passive interaction style with health care services, or being diagnosed with prediabetes at the beginning of the pandemic. Some participants were able to adapt to the increased delivery of support through DHTs. Others had lower capacity to use DHTs, which was caused by lower digital skills, fewer financial resources, and a lack of support to use the tools. Conclusions: Inequalities in motivation, opportunity, and capacity to engage in health services and DHTs lead to unequal possibilities for people with T2D and prediabetes to self-care and receive care during the COVID-19 pandemic. These issues can be addressed by proactive arrangement of regular checkups by primary care services and improving capacity for people with lower digital skills to engage with DHTs. %M 38917452 %R 10.2196/55201 %U https://diabetes.jmir.org/2024/1/e55201 %U https://doi.org/10.2196/55201 %U http://www.ncbi.nlm.nih.gov/pubmed/38917452 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e47704 %T Effectiveness of Web-Based Mindfulness-Based Interventions for Patients With Cancer: Systematic Review and Meta-Analyses %A Wang,Ting %A Tang,Chulei %A Jiang,Xiaoman %A Guo,Yinning %A Zhu,Shuqin %A Xu,Qin %+ School of Nursing, Nanjing Medical University, 101 Longmian Avenue, Jiangning District, Nanjing, 211166, China, 86 13601587208, qinxu@njmu.edu.cn %K cancer %K mindfulness-based interventions %K mental health %K randomized controlled trial %K systematic review %K meta-analysis %K mindfulness %K web-based intervention %K oncology %K delivery mode %K efficacy %K quality of life %K program %K adherence %K mobile phone %D 2024 %7 25.6.2024 %9 Review %J J Med Internet Res %G English %X Background: Cancer has emerged as a considerable global health concern, contributing substantially to both morbidity and mortality. Recognizing the urgent need to enhance the overall well-being and quality of life (QOL) of cancer patients, a growing number of researchers have started using online mindfulness-based interventions (MBIs) in oncology. However, the effectiveness and optimal implementation methods of these interventions remain unknown. Objective: This study evaluates the effectiveness of online MBIs, encompassing both app- and website-based MBIs, for patients with cancer and provides insights into the potential implementation and sustainability of these interventions in real-world settings. Methods: Searches were conducted across 8 electronic databases, including the Cochrane Library, Web of Science, PubMed, Embase, SinoMed, CINAHL Complete, Scopus, and PsycINFO, until December 30, 2022. Randomized controlled trials involving cancer patients aged ≥18 years and using app- and website-based MBIs compared to standard care were included. Nonrandomized studies, interventions targeting health professionals or caregivers, and studies lacking sufficient data were excluded. Two independent authors screened articles, extracted data using standardized forms, and assessed the risk of bias in the studies using the Cochrane Bias Risk Assessment Tool. Meta-analyses were performed using Review Manager (version 5.4; The Cochrane Collaboration) and the meta package in R (R Foundation for Statistical Computing). Standardized mean differences (SMDs) were used to determine the effects of interventions. The Reach, Effectiveness, Adoption, Implementation, and Maintenance framework was used to assess the potential implementation and sustainability of these interventions in real-world settings. Results: Among 4349 articles screened, 15 (0.34%) were included. The total population comprised 1613 participants, of which 870 (53.9%) were in the experimental conditions and 743 (46.1%) were in the control conditions. The results of the meta-analysis showed that compared with the control group, the QOL (SMD 0.37, 95% CI 0.18-0.57; P<.001), sleep (SMD −0.36, 95% CI −0.71 to −0.01; P=.04), anxiety (SMD −0.48, 95% CI −0.75 to −0.20; P<.001), depression (SMD −0.36, 95% CI −0.61 to −0.11; P=.005), distress (SMD −0.50, 95% CI −0.75 to −0.26; P<.001), and perceived stress (SMD −0.89, 95% CI −1.33 to −0.45; P=.003) of the app- and website-based MBIs group in patients with cancer was significantly alleviated after the intervention. However, no significant differences were found in the fear of cancer recurrence (SMD −0.30, 95% CI −1.04 to 0.44; P=.39) and posttraumatic growth (SMD 0.08, 95% CI −0.26 to 0.42; P=.66). Most interventions were multicomponent, website-based health self-management programs, widely used by international and multilingual patients with cancer. Conclusions: App- and website-based MBIs show promise for improving mental health and QOL outcomes in patients with cancer, and further research is needed to optimize and customize these interventions for individual physical and mental symptoms. Trial Registration: PROSPERO CRD42022382219; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=382219 %M 38917445 %R 10.2196/47704 %U https://www.jmir.org/2024/1/e47704 %U https://doi.org/10.2196/47704 %U http://www.ncbi.nlm.nih.gov/pubmed/38917445 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e53940 %T Effects of User Experience in Automated Information Processing on Perceived Usefulness of Digital Contact-Tracing Apps: Cross-Sectional Survey Study %A Schrills,Tim %A Kojan,Lilian %A Gruner,Marthe %A Calero Valdez,André %A Franke,Thomas %+ Institute for Multimedia and Interactive Systems, Universität zu Lübeck, Ratzeburger Allee 160, Lübeck, 23560, Germany, 49 451 3101 ext 5135, Tim.schrills@uni-luebeck.de %K COVID-19 %K contact tracing %K user experience %K trust %K health information processing %D 2024 %7 25.6.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: In pandemic situations, digital contact tracing (DCT) can be an effective way to assess one’s risk of infection and inform others in case of infection. DCT apps can support the information gathering and analysis processes of users aiming to trace contacts. However, users’ use intention and use of DCT information may depend on the perceived benefits of contact tracing. While existing research has examined acceptance in DCT, automation-related user experience factors have been overlooked. Objective: We pursued three goals: (1) to analyze how automation-related user experience (ie, perceived trustworthiness, traceability, and usefulness) relates to user behavior toward a DCT app, (2) to contextualize these effects with health behavior factors (ie, threat appraisal and moral obligation), and (3) to collect qualitative data on user demands for improved DCT communication. Methods: Survey data were collected from 317 users of a nationwide-distributed DCT app during the COVID-19 pandemic after it had been in app stores for >1 year using a web-based convenience sample. We assessed automation-related user experience. In addition, we assessed threat appraisal and moral obligation regarding DCT use to estimate a partial least squares structural equation model predicting use intention. To provide practical steps to improve the user experience, we surveyed users’ needs for improved communication of information via the app and analyzed their responses using thematic analysis. Results: Data validity and perceived usefulness showed a significant correlation of r=0.38 (P<.001), goal congruity and perceived usefulness correlated at r=0.47 (P<.001), and result diagnosticity and perceived usefulness had a strong correlation of r=0.56 (P<.001). In addition, a correlation of r=0.35 (P<.001) was observed between Subjective Information Processing Awareness and perceived usefulness, suggesting that automation-related changes might influence the perceived utility of DCT. Finally, a moderate positive correlation of r=0.47 (P<.001) was found between perceived usefulness and use intention, highlighting the connection between user experience variables and use intention. Partial least squares structural equation modeling explained 55.6% of the variance in use intention, with the strongest direct predictor being perceived trustworthiness (β=.54; P<.001) followed by moral obligation (β=.22; P<.001). Based on the qualitative data, users mainly demanded more detailed information about contacts (eg, place and time of contact). They also wanted to share information (eg, whether they wore a mask) to improve the accuracy and diagnosticity of risk calculation. Conclusions: The perceived result diagnosticity of DCT apps is crucial for perceived trustworthiness and use intention. By designing for high diagnosticity for the user, DCT apps could improve their support in the action regulation of users, resulting in higher perceived trustworthiness and use in pandemic situations. In general, automation-related user experience has greater importance for use intention than general health behavior or experience. %M 38916941 %R 10.2196/53940 %U https://humanfactors.jmir.org/2024/1/e53940 %U https://doi.org/10.2196/53940 %U http://www.ncbi.nlm.nih.gov/pubmed/38916941 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e48298 %T Improvement and Maintenance of Clinical Outcomes in a Digital Mental Health Platform: Findings From a Longitudinal Observational Real-World Study %A Roos,Lydia G %A Sagui-Henson,Sara J %A Castro Sweet,Cynthia %A Welcome Chamberlain,Camille E %A Smith,Brooke J %+ Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, 760 Westwood Plaza, Los Angeles, CA, 90024, United States, 1 8435446005, lroos@mednet.ucla.edu %K digital mental health %K employee health %K depression %K anxiety %K well-being %K mobile phone %D 2024 %7 24.6.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Digital mental health services are increasingly being provided by employers as health benefit programs that can improve access to and remove barriers to mental health care. Stratified care models, in particular, offer personalized care recommendations that can offer clinically effective interventions while conserving resources. Nonetheless, clinical evaluation is needed to understand their benefits for mental health and their use in a real-world setting. Objective: This study aimed to examine the changes in clinical outcomes (ie, depressive and anxiety symptoms and well-being) and to evaluate the use of stratified blended care among members of an employer-sponsored digital mental health benefit. Methods: In a large prospective observational study, we examined the changes in depressive symptoms (9-item Patient Health Questionnaire), anxiety symptoms (7-item Generalized Anxiety Disorder scale), and well-being (5-item World Health Organization Well-Being Index) for 3 months in 509 participants (mean age 33.9, SD 8.7 years; women: n=312, 61.3%; men: n=175, 34.4%; nonbinary: n=22, 4.3%) who were newly enrolled and engaged in care with an employer-sponsored digital mental health platform (Modern Health Inc). We also investigated the extent to which participants followed the recommendations provided to them through a stratified blended care model. Results: Participants with elevated baseline symptoms of depression and anxiety exhibited significant symptom improvements, with a 37% score improvement in depression and a 29% score improvement in anxiety (P values <.001). Participants with baseline scores indicative of poorer well-being also improved over the study period (90% score improvement; P=.002). Furthermore, over half exhibited clinical improvement or recovery for depressive symptoms (n=122, 65.2%), anxiety symptoms (n=127, 59.1%), and low well-being (n=82, 64.6%). Among participants with mild or no baseline symptoms, we found high rates of maintenance for low depressive (n=297, 92.2%) and anxiety (n=255, 86.7%) symptoms and high well-being (n=344, 90.1%). In total, two-thirds of the participants (n=343, 67.4%) used their recommended care, 16.9% (n=86) intensified their care beyond their initial recommendation, and 15.7% (n=80) of participants underused care by not engaging with the highest level of care recommended to them. Conclusions: Participants with elevated baseline depressive or anxiety symptoms improved their mental health significantly from baseline to follow-up, and most participants without symptoms or with mild symptoms at baseline maintained their mental health over time. In addition, engagement patterns indicate that the stratified blended care model was efficient in matching individuals with the most effective and least costly care while also allowing them to self-determine their care and use combinations of services that best fit their needs. Overall, the results of this study support the clinical effectiveness of the platform for improving and preserving mental health and support the utility and effectiveness of stratified blended care models to improve access to and use of digitally delivered mental health services. %M 38913405 %R 10.2196/48298 %U https://mhealth.jmir.org/2024/1/e48298 %U https://doi.org/10.2196/48298 %U http://www.ncbi.nlm.nih.gov/pubmed/38913405 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e56894 %T Parents’ Perceptions of Their Parenting Journeys and a Mobile App Intervention (Parentbot—A Digital Healthcare Assistant): Qualitative Process Evaluation %A Chua,Joelle Yan Xin %A Choolani,Mahesh %A Chee,Cornelia Yin Ing %A Yi,Huso %A Chan,Yiong Huak %A Lalor,Joan Gabrielle %A Chong,Yap Seng %A Shorey,Shefaly %+ Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 2, Clinical Research Centre, Block MD11 10 Medical Drive, Singapore, 117597, Singapore, 65 66011294, nurssh@nus.edu.sg %K perinatal %K parents %K mobile app %K chatbot %K qualitative study %K interviews %K experiences %K mobile phone %D 2024 %7 21.6.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Parents experience many challenges during the perinatal period. Mobile app–based interventions and chatbots show promise in delivering health care support for parents during the perinatal period. Objective: This descriptive qualitative process evaluation study aims to explore the perinatal experiences of parents in Singapore, as well as examine the user experiences of the mobile app–based intervention with an in-built chatbot titled Parentbot—a Digital Healthcare Assistant (PDA). Methods: A total of 20 heterosexual English-speaking parents were recruited via purposive sampling from a single tertiary hospital in Singapore. The parents (control group: 10/20, 50%; intervention group: 10/20, 50%) were also part of an ongoing randomized trial between November 2022 and August 2023 that aimed to evaluate the effectiveness of the PDA in improving parenting outcomes. Semistructured one-to-one interviews were conducted via Zoom from February to June 2023. All interviews were conducted in English, audio recorded, and transcribed verbatim. Data analysis was guided by the thematic analysis framework. The COREQ (Consolidated Criteria for Reporting Qualitative Research) checklist was used to guide the reporting of data. Results: Three themes with 10 subthemes describing parents’ perceptions of their parenting journeys and their experiences with the PDA were identified. The main themes were (1) new babies, new troubles, and new wonders; (2) support system for the parents; and (3) reshaping perinatal support for future parents. Conclusions: Overall, the PDA provided parents with informational, socioemotional, and psychological support and could be used to supplement the perinatal care provided for future parents. To optimize users’ experience with the PDA, the intervention could be equipped with a more sophisticated chatbot, equipped with more gamification features, and programmed to deliver personalized care to parents. Researchers and health care providers could also strive to promote more peer-to-peer interactions among users. The provision of continuous, holistic, and family-centered care by health care professionals could also be emphasized. Moreover, policy changes regarding maternity and paternity leaves, availability of infant care centers, and flexible work arrangements could be further explored to promote healthy work-family balance for parents. %M 38905628 %R 10.2196/56894 %U https://www.jmir.org/2024/1/e56894 %U https://doi.org/10.2196/56894 %U http://www.ncbi.nlm.nih.gov/pubmed/38905628 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e54029 %T Development of an Artificial Intelligence–Based Tailored Mobile Intervention for Nurse Burnout: Single-Arm Trial %A Cho,Aram %A Cha,Chiyoung %A Baek,Gumhee %+ College of Nursing & Graduate Program in System Health Science and Engineering, Ewha Womans University, 52, Ewhayeodae-gil, Seodaemun-gu, Seoul, Hellen #202, Seoul, 03760, Republic of Korea, 82 0232772883, chiyoung@ewha.ac.kr %K artificial intelligence %K burnout %K mobile app %K nurses %K nurse %K mHealth %K mobile health %K app %K apps %K applications %K usability %K satisfaction %K effectiveness %K tailored %K mind-body %K meditation %K mindfulness %K ACT %K algorithm %K algorithms %K occupational health %K digital health %K recommender %K optimization %K acceptance and commitment therapy %K job %K worker %K workers %K stress %K employee %K employees %D 2024 %7 21.6.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Nurse burnout leads to an increase in turnover, which is a serious problem in the health care system. Although there is ample evidence of nurse burnout, interventions developed in previous studies were general and did not consider specific burnout dimensions and individual characteristics. Objective: The objectives of this study were to develop and optimize the first tailored mobile intervention for nurse burnout, which recommends programs based on artificial intelligence (AI) algorithms, and to test its usability, effectiveness, and satisfaction. Methods: In this study, an AI-based mobile intervention, Nurse Healing Space, was developed to provide tailored programs for nurse burnout. The 4-week program included mindfulness meditation, laughter therapy, storytelling, reflective writing, and acceptance and commitment therapy. The AI algorithm recommended one of these programs to participants by calculating similarity through a pretest consisting of participants’ demographics, research variables, and burnout dimension scores measured with the Copenhagen Burnout Inventory. After completing a 4-week program, burnout, job stress, stress response using the Stress Response Inventory Modified Form, the usability of the app, coping strategy by the coping strategy indicator, and program satisfaction (1: very dissatisfied; 5: very satisfied) were measured. The AI recognized the recommended program as effective if the user’s burnout score reduced after the 2-week program and updated the algorithm accordingly. After a pilot test (n=10), AI optimization was performed (n=300). A paired 2-tailed t test, ANOVA, and the Spearman correlation were used to test the effect of the intervention and algorithm optimization. Results: Nurse Healing Space was implemented as a mobile app equipped with a system that recommended 1 program out of 4 based on similarity between users through AI. The AI algorithm worked well in matching the program recommended to participants who were most similar using valid data. Users were satisfied with the convenience and visual quality but were dissatisfied with the absence of notifications and inability to customize the program. The overall usability score of the app was 3.4 out of 5 points. Nurses’ burnout scores decreased significantly after the completion of the first 2-week program (t=7.012; P<.001) and reduced further after the second 2-week program (t=2.811; P=.01). After completing the Nurse Healing Space program, job stress (t=6.765; P<.001) and stress responses (t=5.864; P<.001) decreased significantly. During the second 2-week program, the burnout level reduced in the order of participation (r=–0.138; P=.04). User satisfaction increased for both the first (F=3.493; P=.03) and second programs (F=3.911; P=.02). Conclusions: This program effectively reduced burnout, job stress, and stress responses. Nurse managers were able to prevent nurses from resigning and maintain the quality of medical services using this AI-based program to provide tailored interventions for nurse burnout. Thus, this app could improve qualitative health care, increase employee satisfaction, reduce costs, and ultimately improve the efficiency of the health care system. %M 38905631 %R 10.2196/54029 %U https://www.jmir.org/2024/1/e54029 %U https://doi.org/10.2196/54029 %U http://www.ncbi.nlm.nih.gov/pubmed/38905631 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 10 %N %P e46303 %T Digital Smoking Cessation Intervention for Cancer Survivors: Analysis of Predictors and Moderators of Engagement and Outcome Alongside a Randomized Controlled Trial %A Andree,Rosa %A Mujcic,Ajla %A den Hollander,Wouter %A van Laar,Margriet %A Boon,Brigitte %A Engels,Rutger %A Blankers,Matthijs %+ Trimbos Institute, Netherlands Institute of Mental Health and Addiction, Da Costakade 45, Utrecht, 3521 VS, Netherlands, 31 30 29 59 267, randree@trimbos.nl %K smoking cessation %K cancer survivors %K engagement %K digital intervention %K eHealth %K smoking %K intervention %K randomized controlled trial %K predictor %K RCT %K smoking %K smoker %K addict %K cessation %K quit %K cancer %K oncology %D 2024 %7 20.6.2024 %9 Original Paper %J JMIR Cancer %G English %X Background: Recent studies have shown positive, though small, clinical effects of digital smoking cessation (SC) interventions for cancer survivors. However, research on associations among participant characteristics, intervention engagement, and outcomes is limited. Objective: This study aimed to explore the predictors and moderators of engagement and outcome of MyCourse-Quit Smoking (in Dutch: “MijnKoers-Stoppen met Roken”), a digital minimally guided intervention for cancer survivors. Methods: A secondary analysis of data from the randomized controlled trial was performed. The number of cigarettes smoked in the past 7 days at 6-month follow-up was the primary outcome measure. We analyzed interactions among participant characteristics (11 variables), intervention engagement (3 variables), and outcome using robust linear (mixed) modeling. Results: In total, 165 participants were included in this study. Female participants accessed the intervention less often than male participants (B=–11.12; P=.004). A higher Alcohol Use Disorders Identification Test score at baseline was associated with a significantly higher number of logins (B=1.10; P<.001) and diary registrations (B=1.29; P<.001). A higher Fagerström Test for Nicotine Dependence score at baseline in the intervention group was associated with a significantly larger reduction in tobacco use after 6 months (B=–9.86; P=.002). No other associations and no moderating effects were found. Conclusions: Overall, a limited number of associations was found between participant characteristics, engagement, and outcome, except for gender, problematic alcohol use, and nicotine dependence. Future studies are needed to shed light on how this knowledge can be used to improve the effects of digital SC programs for cancer survivors. Trial Registration: Netherlands Trial register NTR6011/NL5434; https://onderzoekmetmensen.nl/nl/trial/22832 %R 10.2196/46303 %U https://cancer.jmir.org/2024/1/e46303 %U https://doi.org/10.2196/46303 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 11 %N %P e48129 %T The Value of a Virtual Assistant to Improve Engagement in Computerized Cognitive Training at Home: Exploratory Study %A Zsoldos,Isabella %A Trân,Eléonore %A Fournier,Hippolyte %A Tarpin-Bernard,Franck %A Fruitet,Joan %A Fouillen,Mélodie %A Bailly,Gérard %A Elisei,Frédéric %A Bouchot,Béatrice %A Constant,Patrick %A Ringeval,Fabien %A Koenig,Olivier %A Chainay,Hanna %+ Laboratoire d’Étude des Mécanismes Cognitifs, Université Lumière Lyon 2, 5 Avenue Pierre Mendès France, Lyon, 69500, France, 33 478774335, isabella.zsoldos@hotmail.fr %K cognitive training %K cognitive decline %K cognitive disorders %K mild cognitive impairment %K Alzheimer disease %K digital therapies %K virtual health assistant %K conversational agent %K artificial intelligence %K social interaction %K THERADIA %D 2024 %7 20.6.2024 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: Impaired cognitive function is observed in many pathologies, including neurodegenerative diseases such as Alzheimer disease. At present, the pharmaceutical treatments available to counter cognitive decline have only modest effects, with significant side effects. A nonpharmacological treatment that has received considerable attention is computerized cognitive training (CCT), which aims to maintain or improve cognitive functioning through repeated practice in standardized exercises. CCT allows for more regular and thorough training of cognitive functions directly at home, which represents a significant opportunity to prevent and fight cognitive decline. However, the presence of assistance during training seems to be an important parameter to improve patients’ motivation and adherence to treatment. To compensate for the absence of a therapist during at-home CCT, a relevant option could be to include a virtual assistant to accompany patients throughout their training. Objective: The objective of this exploratory study was to evaluate the interest of including a virtual assistant to accompany patients during CCT. We investigated the relationship between various individual factors (eg, age, psycho-affective functioning, personality, personal motivations, and cognitive skills) and the appreciation and usefulness of a virtual assistant during CCT. This study is part of the THERADIA (Thérapies Digitales Augmentées par l’Intelligence Artificielle) project, which aims to develop an empathetic virtual assistant. Methods: A total of 104 participants were recruited, including 52 (50%) young adults (mean age 21.2, range 18 to 27, SD 2.9 years) and 52 (50%) older adults (mean age 67.9, range 60 to 79, SD 5.1 years). All participants were invited to the laboratory to answer several questionnaires and perform 1 CCT session, which consisted of 4 cognitive exercises supervised by a virtual assistant animated by a human pilot via the Wizard of Oz method. The participants evaluated the virtual assistant and CCT at the end of the session. Results: Analyses were performed using the Bayesian framework. The results suggest that the virtual assistant was appreciated and perceived as useful during CCT in both age groups. However, older adults rated the assistant and CCT more positively overall than young adults. Certain characteristics of users, especially their current affective state (ie, arousal, intrinsic relevance, goal conduciveness, and anxiety state), appeared to be related to their evaluation of the session. Conclusions: This study provides, for the first time, insight into how young and older adults perceive a virtual assistant during CCT. The results suggest that such an assistant could have a beneficial influence on users’ motivation, provided that it can handle different situations, particularly their emotional state. The next step of our project will be to evaluate our device with patients experiencing mild cognitive impairment and to test its effectiveness in long-term cognitive training. %M 38901017 %R 10.2196/48129 %U https://rehab.jmir.org/2024/1/e48129 %U https://doi.org/10.2196/48129 %U http://www.ncbi.nlm.nih.gov/pubmed/38901017 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53607 %T Effects of Peer- or Professional-Led Support in Enhancing Adherence to Wearable Monitoring Devices Among Community-Dwelling Older Adults: Systematic Review of Randomized Controlled Trials %A Chan,Colette Sze Wing %A Kan,Mandy Ming Pui %A Wong,Arkers Kwan Ching %+ School of Nursing, The Hong Kong Polytechnic University, GH 502, The Hong Kong Polytechnic University, Hung Hom, 00000, China (Hong Kong), 852 34003805, arkers.wong@polyu.edu.hk %K wearable monitoring device %K older adults %K adherence %K systematic review %K healthy aging %K peer support %K professional help %K support %K peers %K peer %K professionals %K wearable %K monitoring devices %K monitoring device %K community-dwelling %K older adults %K older adult %K aging %K aging %K elderly %D 2024 %7 20.6.2024 %9 Review %J J Med Internet Res %G English %X Background: Despite the well-documented health benefits associated with wearable monitoring devices (WMDs), adherence among community-dwelling older adults remains low. By providing guidance on the purpose and benefits of using WMDs, facilitating goal-setting aligned with the device’s features, promoting comprehension of the health data captured by the device, and assisting in overcoming technological challenges, peers and health care professionals can potentially enhance older adults’ adherence to WMDs. However, the effectiveness of such support mechanisms in promoting adherence to WMDs among older adults remains poorly understood. Objective: The aims of this systematic review were to examine the effects of peer- or professional-led intervention programs designed to improve adherence to WMDs among community-dwelling older adults and to identify the intervention components that may positively influence the effects of the intervention. Methods: We conducted a comprehensive search across 7 electronic databases (Cochrane Central Register of Controlled Trials [CENTRAL], PubMed, EMBASE, PsycINFO, British Nursing Index, Web of Science, and CINAHL) to identify articles published between January 1, 2010, and June 26, 2023. We specifically targeted randomized controlled trials that examined the impact of peer- or professional-led interventions on enhancing adherence to WMDs among individuals aged 60 years and older residing in the community. Two independent reviewers extracted data from the included studies and assessed the potential risk of bias in accordance with the Cochrane Risk of Bias tool for randomized trials, version 2. Results: A total of 10,511 studies were identified through the database search. Eventually, we included 3 randomized controlled trials involving 154 community-dwelling older adults. The participants had a mean age of 65 years. Our review revealed that increasing awareness of being monitored and implementing the SystemCHANGE approach, a habit change tool focusing on personal goals and feedback, were effective strategies for enhancing adherence to WMDs among older adults. All of the included studies exhibited a low risk of bias. Conclusions: By collaboratively designing specific goals related to WMDs with health care professionals, including nurses and physicians, older adults exhibited a higher likelihood of adhering to the prescribed use of WMDs. These goal-setting tools provided a framework for structure and motivation, facilitating the seamless integration of WMDs into their daily routines. Researchers should prioritize interventions that target awareness and goal-setting as effective approaches to enhance adherence to WMDs among older adults, thereby maximizing the realization of associated health benefits. %M 38900546 %R 10.2196/53607 %U https://www.jmir.org/2024/1/e53607 %U https://doi.org/10.2196/53607 %U http://www.ncbi.nlm.nih.gov/pubmed/38900546 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e49515 %T Persuasive Systems Design Trends in Coronary Heart Disease Management: Scoping Review of Randomized Controlled Trials %A Agyei,Eunice Eno Yaa Frimponmaa %A Ekpezu,Akon %A Oinas-Kukkonen,Harri %+ Oulu Advanced Research on Service and Information Systems, Faculty of Information Technology and Electrical Engineering, University of Oulu, Pentti Kaiteran katu 1, Oulu, 90570, Finland, 358 0449511559, eunice.agyei@oulu.fi %K coronary heart disease %K persuasive systems design %K behavior change %K randomized controlled trial %K RCT %K controlled trials %K heart %K CHD %K cardiovascular %D 2024 %7 19.6.2024 %9 Review %J JMIR Cardio %G English %X Background: Behavior change support systems (BCSSs) have the potential to help people maintain healthy lifestyles and aid in the self-management of coronary heart disease (CHD). The Persuasive Systems Design (PSD) model is a framework for designing and evaluating systems designed to support lifestyle modifications and health behavior change using information and communication technology. However, evidence for the underlying design principles behind BCSSs for CHD has not been extensively reported in the literature. Objective: This scoping review aims to identify existing health BCSSs for CHD, report the characteristics of these systems, and describe the persuasion context and persuasive design principles of these systems based on the PSD framework. Methods: Using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines, 3 digital databases (Scopus, Web of Science, and MEDLINE) were searched between 2010 to 2022. The major inclusion criteria for studies were in accordance with the PICO (Population, Intervention, Comparison, and Outcome) approach. Results: Searches conducted in the databases identified 1195 papers, among which 30 were identified as eligible for the review. The most interesting characteristics of the BCSSs were the predominant use of primary task support principles, followed by dialogue support and credibility support and the sparing use of social support principles. Theories of behavior change such as the Social Cognitive Theory and Self-Efficacy Theory were used often to underpin these systems. However, significant trends in the use of persuasive system features on par with behavior change theories could not be established from the reviewed studies. This points to the fact that there is still no theoretical consensus on how best to design interventions to promote behavior change in patients with CHD. Conclusions: Our results highlight key software features for designing BCSSs for the prevention and management of CHD. We encourage designers of behavior change interventions to evaluate the techniques that contributed to the success of the intervention. Future research should focus on evaluating the effectiveness of the interventions, persuasive design principles, and behavior change theories using research methodologies such as meta-analysis. %M 38896840 %R 10.2196/49515 %U https://cardio.jmir.org/2024/1/e49515 %U https://doi.org/10.2196/49515 %U http://www.ncbi.nlm.nih.gov/pubmed/38896840 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e50248 %T Effectiveness of a Multifaceted Mobile Health Intervention (Multi-Aid-Package) in Medication Adherence and Treatment Outcomes Among Patients With Hypertension in a Low- to Middle-Income Country: Randomized Controlled Trial %A Arshed,Muhammad %A Mahmud,Aidalina %A Minhat,Halimatus Sakdiah %A Lim,Poh Ying %A Zakar,Rubeena %+ Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, UPM Serdang, Serdang, 43400, Malaysia, 60 397692416, aidalina@upm.edu.my %K mobile health %K mHealth %K intervention %K medication adherence %K hypertension %K low- to middle-income country %K effectiveness %K randomized controlled trial %K Pakistan %K drug adherence %K tool %K mHealth module %K self-efficacy %K systolic blood pressure %K feedback %D 2024 %7 19.6.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The high prevalence of uncontrolled hypertension in Pakistan is predominantly attributed to poor medication adherence. As more than 137 million people in Pakistan use cell phones, a suitable mobile health (mHealth) intervention can be an effective tool to overcome poor medication adherence. Objective: We sought to determine whether a novel mHealth intervention is useful in enhancing antihypertensive therapy adherence and treatment outcomes among patients with hypertension in a low- to middle-income country. Methods: A 6-month parallel, single-blinded, superiority randomized controlled trial recruited 439 patients with hypertension with poor adherence to antihypertensive therapy and access to smartphones. An innovative, multifaceted mHealth intervention (Multi-Aid-Package), based on the Health Belief Model and containing reminders (written, audio, visual), infographics, video clips, educational content, and 24/7 individual support, was developed for the intervention group; the control group received standard care. The primary outcome was self-reported medication adherence measured using the Self-Efficacy for Appropriate Medication Adherence Scale (SEAMS) and pill counting; the secondary outcome was systolic blood pressure (SBP) change. Both outcomes were evaluated at baseline and 6 months. Technology acceptance feedback was also assessed at the end of the study. A generalized estimating equation was used to control the covariates associated with the probability of affecting adherence to antihypertensive medication. Results: Of 439 participants, 423 (96.4%) completed the study. At 6 months post intervention, the median SEAMS score was statistically significantly higher in the intervention group compared to the controls (median 32, IQR 11 vs median 21, IQR 6; U=10,490, P<.001). Within the intervention group, there was an increase in the median SEAMS score by 12.5 points between baseline and 6 months (median 19.5, IQR 5 vs median 32, IQR 11; P<.001). Results of the pill-counting method showed an increase in adherent patients in the intervention group compared to the controls (83/220, 37.2% vs 2/219, 0.9%; P<.001), as well as within the intervention group (difference of n=83, 37.2% of patients, baseline vs 6 months; P<.001). There was a statistically significant difference in the SBP of 7 mmHg between the intervention and control groups (P<.001) at 6 months, a 4 mmHg reduction (P<.001) within the intervention group, and a 3 mmHg increase (P=.314) within the controls. Overall, the number of patients with uncontrolled hypertension decreased by 46 in the intervention group (baseline vs 6 months), but the control group remained unchanged. The variables groups (adjusted odds ratio [AOR] 1.714, 95% CI 2.387-3.825), time (AOR 1.837, 95% CI 1.625-2.754), and age (AOR 1.618, 95% CI 0.225-1.699) significantly contributed (P<.001) to medication adherence. Multi-Aid-Package received a 94.8% acceptability score. Conclusions: The novel Multi-Aid-Package is an effective mHealth intervention for enhancing medication adherence and treatment outcomes among patients with hypertension in a low- to middle-income country. Trial Registration: ClinicalTrials.gov NCT04577157; https://clinicaltrials.gov/study/NCT04577157 %M 38896837 %R 10.2196/50248 %U https://mhealth.jmir.org/2024/1/e50248 %U https://doi.org/10.2196/50248 %U http://www.ncbi.nlm.nih.gov/pubmed/38896837 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e50503 %T Web-Based, Human-Guided, or Computer-Guided Transdiagnostic Cognitive Behavioral Therapy in University Students With Anxiety and Depression: Randomized Controlled Trial %A Koelen,Jurrijn %A Klein,Anke %A Wolters,Nine %A Bol,Eline %A De Koning,Lisa %A Roetink,Samantha %A Van Blom,Jorien %A Boutin,Bruno %A Schaaf,Jessica %A Grasman,Raoul %A Van der Heijde,Claudia Maria %A Salemink,Elske %A Riper,Heleen %A Karyotaki,Eirini %A Cuijpers,Pim %A Schneider,Silvia %A Rapee,Ronald %A Vonk,Peter %A Wiers,Reinout %+ Department of Developmental Psychology, University of Amsterdam, P.O.Box 15916, 1001 NK, Amsterdam, Netherlands, 31 20 5256842, r.w.h.j.wiers@uva.nl %K internet-based cognitive behavioral intervention %K iCBT %K university students %K transdiagnostic %K human guidance %K technological guidance %D 2024 %7 19.6.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Internet-based cognitive behavioral interventions (iCBTs) are efficacious treatments for depression and anxiety. However, it is unknown whether adding human guidance is feasible and beneficial within a large educational setting. Objective: This study aims to potentially demonstrate the superiority of 2 variants of a transdiagnostic iCBT program (human-guided and computer-guided iCBT) over care as usual (CAU) in a large sample of university students and the superiority of human-guided iCBT over computer-guided iCBT. Methods: A total of 801 students with elevated levels of anxiety, depression, or both from a large university in the Netherlands were recruited as participants and randomized to 1 of 3 conditions: human-guided iCBT, computer-guided iCBT, and CAU. The primary outcome measures were depression (Patient Health Questionnaire) and anxiety (Generalized Anxiety Disorder scale). Secondary outcomes included substance use–related problems (Alcohol Use Disorder Identification Test and Drug Abuse Screening Test—10 items). Linear mixed models were used to estimate the effects of time, treatment group, and their interactions (slopes). The primary research question was whether the 3 conditions differed in improvement over 3 time points (baseline, midtreatment, and after treatment) in terms of depression and anxiety symptoms. Results were analyzed according to the intention-to-treat principle using multiple imputation. Patients were followed exploratively from baseline to 6 and 12 months. Results: In both short-term and long-term analyses, the slopes for the 3 conditions did not differ significantly in terms of depression and anxiety, although both web-based interventions were marginally more efficacious than CAU over 6 months (P values between .02 and .03). All groups showed significant improvement over time (P<.001). For the secondary outcomes, only significant improvements over time (across and not between groups) were found for drug use (P<.001). Significant differences were found in terms of adherence, indicating that participants in the human-guided condition did more sessions than those in the computer-guided condition (P=.002). Conclusions: The transdiagnostic iCBT program offers a practical, feasible, and efficacious alternative to usual care to tackle mental health problems in a large university setting. There is no indication that human guidance should be preferred over technological guidance. The potential preference of human support also depends on the scale of implementation and cost-effectiveness, which need to be addressed in future trials. Trial Registration: International Clinical Trials Registry Platform NL7328/NTR7544; https://trialsearch.who.int/Trial2.aspx?TrialID=NL-OMON26795 %M 38896474 %R 10.2196/50503 %U https://mental.jmir.org/2024/1/e50503 %U https://doi.org/10.2196/50503 %U http://www.ncbi.nlm.nih.gov/pubmed/38896474 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e52494 %T Adapting an Efficacious Peer-Delivered Physical Activity Program for Survivors of Breast Cancer for Web Platform Delivery: Protocol for a 2-Phase Study %A Pinto,Bernardine M %A Patel,Ashwin %A Ostendorf,Danielle M %A Huebschmann,Amy G %A Dunsiger,Shira I %A Kindred,Madison M %+ College of Nursing, University of South Carolina, 1601 Greene Street, Rm 302B, Columbia, SC, 29208, United States, 1 8037779272, Pintob@mailbox.sc.edu %K physical activity adoption %K web platform %K breast cancer survivors %K design %K implementation %K cost-effectiveness %K mobile phone %D 2024 %7 19.6.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Interventions promoting physical activity (PA) among survivors of cancer improve their functioning, reduce fatigue, and offer other benefits in cancer recovery and risk reduction for future cancer. There is a need for interventions that can be implemented on a wider scale than that is possible in research settings. We have previously demonstrated that a 3-month peer-delivered PA program (Moving Forward Together [MFT]) significantly increased the moderate to vigorous PA (MVPA) of survivors of breast cancer. Objective: Our goal is to scale up the MFT program by adapting an existing peer mentoring web platform, Mentor1to1. InquistHealth’s web platform (Mentor1to1) has demonstrated efficacy in peer mentoring for chronic disease management. We will partner with InquisitHealth to adapt their web platform for MFT. The adaptation will allow for automating key resource-intensive components such as matching survivors with a coach via the web-based peer mentoring platform and collecting key indexes to prepare for large-scale implementation. The aim is to streamline intervention delivery, assure fidelity, and improve survivor outcomes. Methods: In phase 1 of this 2-phase study, we will interview 4 peer mentors or coaches with experience in delivering MFT and use their feedback to create Mentor1to1 web platform adapted for MFT (webMFT). Next, another 4 coaches will participate in rapid, iterative user-centered testing of webMFT. In phase 2, we will conduct a randomized controlled trial by recruiting and training 10 to 12 coaches from cancer organizations to deliver webMFT to 56 survivors of breast cancer, who will be assigned to receive either webMFT or MVPA tracking (control) for 3 months. We will assess effectiveness with survivors’ accelerometer-measured MVPA and self-reported psychosocial well-being at baseline and 3 months. We will assess implementation outcomes, including acceptability, feasibility, and program costs from the perspective of survivors, coaches, and collaborating organizations, as guided by the expanded Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Results: As of September 2023, phase 1 of the study was completed, and 61 survivors were enrolled in phase 2. Using newer technologies for enhanced intervention delivery, program management, and automated data collection has the exciting promise of facilitating effective implementation by organizations with limited resources. Adapting evidence-based MFT to a customized web platform and collecting data at multiple levels (coaches, survivors, and organizations) along with costs will provide a strong foundation for a robust multisite implementation trial to increase MVPA and its benefits among many more survivors of breast cancer. Conclusions: The quantitative and qualitative data collected from survivors of cancer, coaches, and organizations will be analyzed to inform a future larger-scale trial of peer mentoring for PA delivered by cancer care organizations to survivors. Trial Registration: ClinicalTrials.gov NCT05409664; https://clinicaltrials.gov/study/NCT05409664 International Registered Report Identifier (IRRID): DERR1-10.2196/52494 %M 38896452 %R 10.2196/52494 %U https://www.researchprotocols.org/2024/1/e52494 %U https://doi.org/10.2196/52494 %U http://www.ncbi.nlm.nih.gov/pubmed/38896452 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e50452 %T Relapse Prevention Group Therapy in Indonesia Involving Peers via Videoconferencing for Substance Use Disorder: Development and Feasibility Study %A Siste,Kristiana %A Ophinni,Youdiil %A Hanafi,Enjeline %A Yamada,Chika %A Novalino,Reza %A Limawan,Albert P %A Beatrice,Evania %A Rafelia,Vania %A Alison,Peter %A Matsumoto,Toshihiko %A Sakamoto,Ryota %+ Department of Environmental Coexistence, Center for Southeast Asian Studies, Kyoto University, 46 Yoshidashimoadachicho, Sakyo Ward, Kyoto, 606-8304, Japan, 81 757537351, chika128@cseas.kyoto-u.ac.jp %K substance use disorder %K cognitive behavioral therapy %K telemedicine %K peer involvement %K Indonesia %K substance use disorders %K digital intervention %K COVID-19 %K psychotherapy %K drug %K mobile phone %D 2024 %7 18.6.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Substance use disorder (SUD) is a major health issue in Indonesia, where several barriers to treatment exist, including inaccessibility to treatment services, stigma, and criminalization of drug issues. Peer involvement and the use of telemedicine to deliver psychotherapy are promising approaches to overcome these barriers. Objective: This study aims (1) to describe the development of a new group psychotherapy coprovided by a health care worker and a peer and (2) to evaluate the acceptability, practicality, and preliminary outcomes of the program delivered via videoconferencing in Indonesia. Methods: Building upon an established relapse prevention therapy in Japan, we developed a 3-month weekly group therapy module in the Indonesian language. Adjustments were made via focus group discussions with local stakeholders in terms of substance types, understandability, inclusive language, and cultural relevance. A pilot study was conducted to test the new module provided by a peer and a psychiatrist via videoconferencing, termed tele-Indonesia Drug Addiction Relapse Prevention Program (tele-Indo-DARPP), with a pre- and postcontrolled design. We analyzed data from semistructured feedback interviews and outcome measurements, including the number of days using substances and quality of life, and compared the intervention (tele-Indo-DARPP added to treatment as usual [TAU]) and control (TAU only) arms. Results: In total, 8 people diagnosed with SUD participated in the pilot study with a mean age of 37 (SD 12.8) years. All were men, and 7 (88%) used sedatives as the primary substance. Collectively, they attended 44 of the 48 tele-Indo-DARPP sessions. A total of 3 out of 4 (75%) preferred telemedicine rather than in-person therapy. Positive acceptability and practicality were shown from qualitative feedback, in which the participants who joined the tele-Indo-DARPP reported that they liked the convenience of joining from home and that they were able to open up about personal matters, received helpful advice from peers, and received support from other participants. Providers reported that they feel the module was provider-friendly, and the session was convenient to join without diminishing rapport-building. Meanwhile, troubles with the internet connection and difficulty in comprehending some terminology in the workbook were reported. The intervention arm showed better improvements in psychological health and anxiety symptoms. Conclusions: Group psychotherapy via videoconferencing coprovided by health care workers and peers was acceptable and practical for participants with SUD and service providers in this study. A large-scale study is warranted to examine the effectiveness of the newly developed module in Indonesia. %M 38888959 %R 10.2196/50452 %U https://formative.jmir.org/2024/1/e50452 %U https://doi.org/10.2196/50452 %U http://www.ncbi.nlm.nih.gov/pubmed/38888959 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53966 %T Web-Based Mindfulness-Based Cognitive Therapy for Adults With a History of Depression: Protocol for a Randomized Controlled Trial %A Hooshmand Zaferanieh,Mohammad %A Shi,Lu %A Jindal,Meenu %A Chen,Liwei %A Zhang,Lingling %A Lopes,Snehal %A Jones,Karyn %A Wang,Yucheng %A Meggett,Kinsey %A Walker,Cari Beth %A Falgoust,Grace %A Zinzow,Heidi %+ University of South Carolina School of Medicine Greenville, 607 Grove Road, Greenville, SC, 29605, United States, 1 864 455 7992, hooshmam@email.sc.edu %K mindfulness-based cognitive therapy %K MBCT %K mindfulness-based interventions %K depression %K depressive symptoms %K virtual delivery %K mindfulness %K mental health %K depressive %K distress %K stress %K remote %K randomized %K controlled trial %K controlled trials %K RCT %K psychotherapy %K cognitive therapy %D 2024 %7 18.6.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Depression poses a major threat to public health with an increasing prevalence in the United States. Mindfulness-based interventions, such as mindfulness-based cognitive therapy (MBCT), are effective methods for managing depression symptoms and may help fortify existing efforts to address the current disease burden. The in-person group format of MBCT, however, incurs barriers to care such as expenses, childcare needs, and transportation issues. Alternate delivery modalities such as MBCT delivered via the web can be investigated for their capacity to overcome these barriers and still reduce symptoms of depression with adequate feasibility and efficacy. Objective: This study protocol aims to examine the feasibility and efficacy of MBCT delivered via the web for the treatment of depression. Methods: To attain study aims, 2 phases will be implemented using a waitlist control design. A total of 128 eligible participants will be randomized into either an 8-week MBCT intervention group plus treatment as usual (MBCT + TAU; group 1) or an 8-week waitlist control group (group 2). In phase I (8 weeks), group 1 will complete the intervention and group 2 will proceed with TAU. In phase II (8 weeks), group 2 will complete the intervention and group 1 will continue with TAU until reaching an 8-week follow-up. TAU may consist of receiving psychotherapy, pharmacotherapy, or combined treatment. Data collection will be completed at baseline, 8 weeks (postintervention for group 1 and preintervention for group 2), and 16 weeks (follow-up for group 1, postintervention for group 2). The primary outcomes will include (1) current, residual, or chronic depression symptoms and (2) psychiatric distress. Secondary outcomes will include perceived stress and facets of mindfulness. The feasibility will be measured by assessing protocol adherence, retention, attendance, and engagement. Finally, the extent of mindfulness self-practice and executive functioning skills will be assessed as mediators of intervention outcomes. Results: This study began screening and recruitment in December 2022. Data collection from the first cohort occurred in January 2023. By November 2023, a total of 30 participants were enrolled out of 224 who received screening. Data analysis began in February 2024, with an approximate publication of results by August 2024. Institutional review board approval took place on September 11, 2019. Conclusions: This trial will contribute to examining mindfulness-based interventions, delivered via the web, for improving current, residual, or chronic depression symptoms. It will (1) address the feasibility of MBCT delivered via the web; (2) contribute evidence regarding MBCT’s efficacy in reducing depression symptoms and psychiatric distress; and (3) assess the impact of MBCT on several important secondary outcomes. Findings from this study will develop the understanding of the causal pathways between MBCT delivered via the web and depression symptoms further, elucidating the potential for future larger-scale designs. Trial Registration: ClinicalTrials.gov NCT05347719; https://www.clinicaltrials.gov/ct2/show/NCT05347719 International Registered Report Identifier (IRRID): DERR1-10.2196/53966 %M 38888958 %R 10.2196/53966 %U https://www.researchprotocols.org/2024/1/e53966 %U https://doi.org/10.2196/53966 %U http://www.ncbi.nlm.nih.gov/pubmed/38888958 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e49010 %T Web-Based Forums for People Experiencing Substance Use or Gambling Disorders: Scoping Review %A Peart,Annette %A Horn,Freya %A Petukhova,Rachel %A Barnett,Anthony %A Lubman,Dan I %+ Eastern Health Clinical School, Monash University, Level 2, 110 Church St, Richmond, Victoria, 3121, Australia, 61 3 8413 8413, annette.peart@monash.edu %K web-based forums %K peer support %K substance use %K gambling %K scoping %K review method %K review methodology %K forum %K forums %K substance abuse %K addiction %K addictive %K addictions %K peer-based %K peer support %D 2024 %7 17.6.2024 %9 Review %J JMIR Ment Health %G English %X Background: For people experiencing substance use or gambling disorders, web-based peer-supported forums are a space where they can share their experiences, gather around a collective goal, and find mutual support. Web-based peer support can help to overcome barriers to attending face-to-face meetings by enabling people experiencing addiction to seek support beyond their physical location and with the benefit of anonymity if desired. Understanding who participates in web-based peer-supported forums (and how), and the principles underpinning forums, can also assist those interested in designing or implementing similar platforms. Objective: This study aims to review the literature on how people experiencing substance use or gambling disorders, and their family, friends, and supporters, use and participate in web-based peer-supported forums. Specifically, we asked the following research questions: (1) What are the characteristics of people who use web-based peer-supported substance use or gambling-focused forums? (2) How do people participate in web-based peer-supported forums? (3) What are the key principles reportedly underpinning the web-based peer-supported forums? (4) What are the reported outcomes of web-based peer-supported forums? Methods: Inclusion criteria for our scoping review were peer-reviewed primary studies reporting on web-based addiction forums for adults and available in English. A primary search of 10 databases occurred in June 2021, with 2 subsequent citation searches of included studies in September 2022 and February 2024. Results: Of the 14 included studies, the majority of web-based peer-supported forums reported were aimed specifically for, or largely used by, people experiencing alcohol problems. Results from the 9 studies that did report demographic data suggest forum users were typically women, aged between 40 years and early 50 years. Participation in web-based peer-supported forums was reported quantitatively and qualitatively. The forums reportedly were underpinned by a range of key principles, mostly mutual help approaches and recovery identity formation. Only 3 included studies reported on outcomes for forum users. Conclusions: Web-based peer-supported forums are used by people experiencing addiction in a number of ways, to share information and experiences, and give and receive support. Seeking web-based support offers an alternative approach to traditional face-to-face support options, and may reduce some barriers to engaging in peer support. %M 38885012 %R 10.2196/49010 %U https://mental.jmir.org/2024/1/e49010 %U https://doi.org/10.2196/49010 %U http://www.ncbi.nlm.nih.gov/pubmed/38885012 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e50557 %T Web-Based Tool Designed to Encourage Supplemental Nutrition Assistance Program Use in Urban College Students: Usability Testing Study %A Li,Catherine Yan Hei %A Platkin,Charles %A Chin,Jonathan %A Khan,Asia %A Bennett,Jaleel %A Speck,Anna %A Nielsen,Annette %A Leung,May May %+ Friedman School of Nutrition Science and Policy, Tufts University, 150 Harrison Ave, Boston, MA, 02111, United States, 1 617 636 3676, maymay.leung@tufts.edu %K SNAP %K SNAP eligibility screening %K food insecurity %K college students %K web-based tool %K think-aloud %K system usability %K user experience %K student %K college %K chronic health %K stress %K anxiety %K barrier %K technology %K tool %K Supplemental Nutrition Assistance Program %K usability %D 2024 %7 13.6.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Food insecurity continues to be a risk for college students in the United States. It is associated with numerous problems, such as chronic health conditions, increased stress and anxiety, and a lower grade point average. After COVID-19, the Supplemental Nutrition Assistance Program (SNAP) benefits were extended to college-aged students; however, there were some barriers to participation, which persisted such as lack of perceived food insecurity risk, lack of knowledge regarding the SNAP application process, the complexity of determining eligibility, and stigma associated with needing social assistance. A technology-enhanced tool was developed to address these barriers to SNAP enrollment and encourage at-risk college students to apply for SNAP. Objective: The purpose of this study was to test the usability and acceptability of a web-based SNAP screening tool designed for college-aged students. Methods: College students aged 18-25 years were recruited to participate in 2 rounds of usability testing during fall 2022. Participants tested the prototype of a web-based SNAP screener tool using a standardized think-aloud method. The usability and acceptability of the tool were assessed using a semistructured interview and a 10-item validated System Usability Scale questionnaire. Audio recordings and field notes were systematically reviewed by extracting and sorting feedback as positive or negative comments. System Usability Scale questionnaire data were analyzed using the Wilcoxon signed rank test and sign test. Results: A total of 12 students (mean age 21.8, SD 2.8 years; n=6, 50% undergraduate; n=11, 92% female; n=7, 58% Hispanic or Black or African American; n=9, 78% low or very low food security) participated in both rounds of user testing. Round 1 testing highlighted overall positive experiences with the tool, with most participants (10/12) stating that the website fulfills its primary objective as a support tool to encourage college students to apply for SNAP. However, issues related to user interface design, navigation, and wording of some questions in the screening tool were noted. Key changes after round 1 reflected these concerns, including improved design of response buttons and tool logo and improved clarity of screening questions. The overall system usability showed slight, but not statistically significant, improvement between round 1 and round 2 (91.25 vs 92.50; P=.10, respectively). Conclusions: Overall usability findings suggest that this web-based tool was highly usable and acceptable to urban college students and could be an effective and appealing approach as a support tool to introduce college students to the SNAP application process. The findings from this study will inform further development of the tool, which could eventually be disseminated publicly among various college campuses. %M 38869926 %R 10.2196/50557 %U https://formative.jmir.org/2024/1/e50557 %U https://doi.org/10.2196/50557 %U http://www.ncbi.nlm.nih.gov/pubmed/38869926 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e48605 %T Developing a Tailored eHealth Self-Management Intervention for Patients With Chronic Kidney Disease in China: Intervention Mapping Approach %A Shen,Hongxia %A van der Kleij,Rianne %A van der Boog,Paul J M %A Chavannes,Niels H %+ School of Nursing, Guangzhou Medical University, 195# Dongfeng West Road, Guangzhou, 510000, China, 86 13937118104, H.Shen@lumc.nl %K eHealth %K self-management %K intervention mapping %K chronic kidney disease %K intervention development %K mobile phone %D 2024 %7 13.6.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Chronic kidney disease (CKD) is a major public health concern. Adequate self-management skills are vital to reduce CKD burden, optimize patient health outcomes, and control health care expenditures. Using eHealth to support CKD self-management has the potential to promote healthy behaviors and improve health outcomes of patients with CKD. However, knowledge of the implementation of such interventions in general, and in China specifically, is still limited. Objective: This study aims to develop a tailored eHealth self-management intervention for patients with CKD in China based on the Dutch Medical Dashboard (MD) eHealth self-management intervention. Methods: We used an intervention mapping approach. In phase 1, a systematic review and 2 qualitative studies were conducted to examine the needs, beliefs, and perceptions of patients with CKD and health care professionals regarding CKD self-management and eHealth interventions. Afterward, key factors gathered from the aforementioned studies were categorized following the 5 domains of the Consolidated Framework for Implementation Research (CFIR). In phase 2, we specified program outcomes, performance objectives, determinants, theory-based methods, and practical strategies. Knowledge obtained from previous results was combined to complement core components of the MD self-management intervention and adapt them for Chinese patients with CKD. Additionally, the CFIR–Expert Recommendations for Implementing Change Matching Tool was pragmatically used to generate a list of potential implementation strategies to address the key factors influencing the implementation of eHealth CKD self-management interventions, and implementation strategies were discussed and finalized with the intervention monitoring group. Results: An overview of the CFIR domains showed the essential factors influencing the implementation of eHealth CKD self-management interventions in Chinese settings, including “knowledge and beliefs” in the domain “individual characteristics,” “quality and advantage of eHealth intervention” in the domain “intervention characteristics,” “compatibility” in the domain “inner setting,” and “cultural context” in the domain “outer setting.” To ensure the effectiveness of the Dutch MD–based self-management intervention, we did not change the core self-management intervention components of MD that underlie its effectiveness, such as self-monitoring. We identified surface-level cultural adaptations involving customizing intervention content, messages, and approaches to the observable cultural characteristics of the local population to enhance the intervention’s appeal, receptivity, and feasibility, such as providing video or voice call options to support interactions with health care professionals. Furthermore, the adapted modules such as Knowledge Center and My Self-Monitoring were developed in a mobile health app. Conclusions: Our study resulted in the delivery of a culturally tailored, standardized eHealth self-management intervention for patients with CKD in China that has the potential to optimize patients’ self-management skills and improve health status and quality of life. Moreover, our study’s research approach and results can inform future research on the tailoring and translation of evidence-based, eHealth self-management interventions to various contexts. Trial Registration: ClinicalTrials.gov NCT04212923; https://classic.clinicaltrials.gov/ct2/show/NCT04212923 %M 38869943 %R 10.2196/48605 %U https://formative.jmir.org/2024/1/e48605 %U https://doi.org/10.2196/48605 %U http://www.ncbi.nlm.nih.gov/pubmed/38869943 %0 Journal Article %@ 2291-5222 %I %V 12 %N %P e54946 %T Engagement in mHealth-Prompted Self-Measured Blood Pressure Monitoring Among Participants Recruited From a Safety-Net Emergency Department: Secondary Analysis of the Reach Out Trial %A Skolarus,Lesli E %A Lin,Chun Chieh %A Mishra,Sonali %A Meurer,William %A Dinh,Mackenzie %A Whitfield,Candace %A Bi,Ran %A Brown,Devin %A Oteng,Rockefeller %A Buis,Lorraine R %A Kidwell,Kelley %K hypertension %K self-measured blood pressure %K mobile health %K blood pressure %K emergency %K blood pressure monitoring %K risk factor %K cardiovascular %K cardiovascular disease %K utilization %K feedback %K care %K systolic blood pressure %K emergency department %K mHealth %K health disparities %K engagement %D 2024 %7 12.6.2024 %9 %J JMIR Mhealth Uhealth %G English %X Background: Hypertension, a key modifiable risk factor for cardiovascular disease, is more prevalent among Black and low-income individuals. To address this health disparity, leveraging safety-net emergency departments for scalable mobile health (mHealth) interventions, specifically using text messaging for self-measured blood pressure (SMBP) monitoring, presents a promising strategy. This study investigates patterns of engagement, associated factors, and the impact of engagement on lowering blood pressure (BP) in an underserved population. Objective: We aimed to identify patterns of engagement with prompted SMBP monitoring with feedback, factors associated with engagement, and the association of engagement with lowered BP. Methods: This is a secondary analysis of data from Reach Out, an mHealth, factorial trial among 488 hypertensive patients recruited from a safety-net emergency department in Flint, Michigan. Reach Out participants were randomized to weekly or daily text message prompts to measure their BP and text in their responses. Engagement was defined as a BP response to the prompt. The k-means clustering algorithm and visualization were used to determine the pattern of SMBP engagement by SMBP prompt frequency—weekly or daily. BP was remotely measured at 12 months. For each prompt frequency group, logistic regression models were used to assess the univariate association of demographics, access to care, and comorbidities with high engagement. We then used linear mixed-effects models to explore the association between engagement and systolic BP at 12 months, estimated using average marginal effects. Results: For both SMBP prompt groups, the optimal number of engagement clusters was 2, which we defined as high and low engagement. Of the 241 weekly participants, 189 (78.4%) were low (response rate: mean 20%, SD 23.4) engagers, and 52 (21.6%) were high (response rate: mean 86%, SD 14.7) engagers. Of the 247 daily participants, 221 (89.5%) were low engagers (response rate: mean 9%, SD 12.2), and 26 (10.5%) were high (response rate: mean 67%, SD 8.7) engagers. Among weekly participants, those who were older (>65 years of age), attended some college (vs no college), married or lived with someone, had Medicare (vs Medicaid), were under the care of a primary care doctor, and took antihypertensive medication in the last 6 months had higher odds of high engagement. Participants who lacked transportation to appointments had lower odds of high engagement. In both prompt frequency groups, participants who were high engagers had a greater decline in BP compared to low engagers. Conclusions: Participants randomized to weekly SMBP monitoring prompts responded more frequently overall and were more likely to be classed as high engagers compared to participants who received daily prompts. High engagement was associated with a larger decrease in BP. New strategies to encourage engagement are needed for participants with lower access to care. Trial Registration: ClinicalTrials.gov NCT03422718; https://clinicaltrials.gov/study/NCT03422718 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-020-04340-z %R 10.2196/54946 %U https://mhealth.jmir.org/2024/1/e54946 %U https://doi.org/10.2196/54946 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e55578 %T Effectiveness of Mobile-Based Progressive and Fixed Physical Activity on Depression, Stress, Anxiety, and Quality of Life Outcomes Among Adults in South Korea: Randomized Controlled Trial %A Lee,Ye Hoon %A Kim,Hyungsook %A Hwang,Juhee %A Noh,Sihyeon %+ Department of Data Science, Hanyang University, 222, Wangsimni-ro, Seongdong-gu, Seoul, 04763, Republic of Korea, 82 222204751, khsook12@hanyang.ac.kr %K depressive symptoms %K mental health %K mobile-based exercise %K non–face-to-face physical activity %K progressive exercise %K mobile phone %D 2024 %7 12.6.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Depression acts as a significant obstacle to the overall well-being of individuals. Given the significant consequences, timely recognition and proactive steps to manage symptoms of depression become essential. Such actions not only reduce personal distress but also play a crucial role in reducing its far-reaching impact on society as a whole. Objective: In response to this concern, the objective of this study was to explore the use of mobile-based interventions as a possible remedy. More specifically, this study aimed to investigate the effectiveness of 2 types of physical activity (PA), progressive and fixed, within a mobile-based app on depression, perceived stress, anxiety, physical health, and psychological health, aiming to contribute to the optimization of mental health benefits. Methods: Participants (N=60; mean age 25.29, SD 6.10 years) were recruited using a combination of web-based and offline methods, and the study lasted for 8 weeks. The baseline and posttest questionnaires were administered to all participants. The participants were randomly assigned to 1 of the 3 groups: progressive group (n=20; performing mobile-based progressive PA), fixed group (n=20; performing mobile-based fixed intensity PA), and control group C (n=20). Data analysis involved comparing scores between the experimental and control groups using a one-way ANOVA, paired sample t tests (2-tailed), and repeated measures ANOVA with a 3 (group)×2 (time) design. Results: The findings revealed significant improvements in mental health indicators among participants engaged in both fixed and progressive PA groups compared with the control group. However, the fixed PA group demonstrated more significant reductions in symptoms. Specifically, the progressive PA group showed significant reductions in depression (F1,36=6.941; P=.01; ηp2=0.16) and perceived stress (F1,36=5.47; P=.03; ηp2=0.13), while the fixed PA group exhibited significant reductions in depression (F1,37=5.36; P=.03; ηp2=0.12), perceived stress (F1,37=7.81; P=.008; ηp2=0.17), and general anxiety disorder (F1,37=5.45; P=.03; ηp2=0.13) compared with the control group. Conclusions: This study underscores the potential of mobile-based PA in improving mental health outcomes. The findings offer significant insights for mental health professionals and researchers aiming to optimize mental well-being through innovative mobile therapies. Trial Registration: Clinical Research Information Service KCT0009100; https://tinyurl.com/mr33fmur %M 38865705 %R 10.2196/55578 %U https://mhealth.jmir.org/2024/1/e55578 %U https://doi.org/10.2196/55578 %U http://www.ncbi.nlm.nih.gov/pubmed/38865705 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e55283 %T Web-Based Therapist-Guided Mindfulness-Based Cognitive Behavioral Therapy for Body Dysmorphic Disorder: Pilot Randomized Controlled Trial %A Kerry,Camrie %A Mann,Prabhdeep %A Babaei,Nazanin %A Katz,Joel %A Pirbaglou,Meysam %A Ritvo,Paul %+ School of Kinesiology and Health Sciences, York University, 4700 Keele St, Toronto, ON, M3J 1P3, Canada, 1 416 580 8021, camrie@yorku.ca %K body dysmorphic disorder %K BDD %K dysmorphophobia %K obsessive-compulsive and related disorders %K OCD %K internet-delivered cognitive behavior therapy %K iCBT %K cognitive behavior therapy %K mindfulness-based cognitive therapy %K mindfulness %K eMental health %K randomized controlled trial %D 2024 %7 12.6.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Internet-based cognitive behavioral therapy (CBT) and stand-alone mindfulness meditation interventions are gaining empirical support for a wide variety of mental health conditions. In this study, we test the efficacy of web-based therapist-guided mindfulness-based cognitive behavioral therapy (CBT-M) for body dysmorphic disorder (BDD), a psychiatric disorder characterized by preoccupations with perceived defects in appearance. Objective: This study aims to determine whether CBT-M for BDD delivered on the web is feasible and acceptable and whether mindfulness meditation adds to CBT treatment effects for BDD. Methods: In this 8-week, 2-arm, parallel pilot randomized controlled trial, n=28 adults (aged between 18 and 55 years) were randomly allocated to an experimental group (web-based therapist-guided CBT-M) or a control group (web-based therapist-guided CBT). Study retention, accrual, and intervention adherence were assessed, along with self-report measures for BDD, depression, anxiety, and pain intensity taken at baseline and postintervention. Results: This study was feasible to implement and deemed acceptable by participants. After 8 weeks, significant improvements were found on all outcome measures for both treatment groups, and large between-group effect sizes favoring CBT-M were found for BDD symptom severity (d=–0.96), depression (d=–1.06), pain severity (d=–1.12), and pain interference (d=–1.28). However, linear mixed models demonstrated no significant differences between the groups over 8 weeks. Conclusions: The results suggest that mindfulness meditation may add to beneficial web-based CBT treatment effects for BDD. An adequately powered randomized control trial of web-based CBT-M is warranted. Trial Registration: ClinicalTrials.gov NCT05402475, http://clinicaltrials.gov/ct2/show/NCT05402475 %M 38865704 %R 10.2196/55283 %U https://mental.jmir.org/2024/1/e55283 %U https://doi.org/10.2196/55283 %U http://www.ncbi.nlm.nih.gov/pubmed/38865704 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e55557 %T Online Cognitive Stimulation Therapy for Dementia in Brazil and India: Acceptability, Feasibility, and Lessons for Implementation %A Fisher,Emily %A Venkatesan,Shreenila %A Benevides,Pedro %A Bertrand,Elodie %A Brum,Paula Schimidt %A El Baou,Céline %A Ferri,Cleusa P %A Fossey,Jane %A Jelen,Maria %A Laks,Jerson %A Liu,Lisa %A Mograbi,Daniel C %A Natarajan,Nirupama %A Naylor,Renata %A Pantouli,Despina %A Ramanujam,Vaishnavi %A Rangaswamy,Thara %A Santos de Carvalho,Raquel L %A Stoner,Charlotte %A Vaitheswaran,Sridhar %A Spector,Aimee %+ University College London, Gower Street, London, WC1E 6BT, United Kingdom, 44 20 7679 5770, emily.fisher@ucl.ac.uk %K psychosocial %K intervention %K technology %K COVID-19 %K LMIC %K low and middle income countries %D 2024 %7 11.6.2024 %9 Original Paper %J JMIR Aging %G English %X Background: Cognitive stimulation therapy (CST) is an evidence-based, group psychosocial intervention for people with dementia, and it has a positive impact on cognition and quality of life. CST has been culturally adapted for use globally. It was developed as a face-to-face intervention but has recently been adapted for online delivery. Objective: In this study, we aimed to explore the feasibility and acceptability of online or virtual CST (vCST) delivery in India and Brazil, emphasizing barriers and facilitators to implementation. Methods: A single-group, multisite, mixed methods, feasibility study was conducted, with nested qualitative interviews. Primary feasibility outcomes were recruitment rate, attendance, attrition, acceptability, and outcome measure completion. Exploratory pre- and postintervention measures, including cognition and quality of life, were assessed. Qualitative interviews were conducted with people with dementia, family caregivers, and group and organizational leaders following intervention delivery, and the data were analyzed using the Consolidated Framework for Implementation Research. Results: A total of 17 vCST group sessions with 59 participants were conducted for 7 weeks, with 53% (31/59) of participants attending all 14 sessions. Attrition rate was 7% (4/59), and outcome measure completion rate at follow-up was 68% (40/59). Interviews took place with 36 stakeholders. vCST was acceptable to participants and group leaders and enabled vital access to services during pandemic restrictions. While online services broadened geographic access, challenges emerged concerning inadequate computer literacy, poor technology access, and establishing interpersonal connections online. Exploratory, uncontrolled analyses indicated positive trends in quality of life but negative trends in cognition and activities of daily living, but these results were not statistically significant. Conclusions: vCST demonstrated feasibility and acceptability, serving as a crucial resource during the pandemic but raised challenges related to technology access, computer literacy, and long-term implementation. The study highlights the potential of vCST while emphasizing ongoing development and solutions to address implementation challenges. %M 38861708 %R 10.2196/55557 %U https://aging.jmir.org/2024/1/e55557 %U https://doi.org/10.2196/55557 %U http://www.ncbi.nlm.nih.gov/pubmed/38861708 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e52341 %T The Effects of mHealth Interventions on Quality of Life, Anxiety, and Depression in Patients With Coronary Heart Disease: Meta-Analysis of Randomized Controlled Trials %A Hou,Qiao Ling %A Liu,Le Yang %A Wu,Ying %+ School of Nursing, Capital Medical University, 10 You-an-men Wai Xi-tou-tiao, Feng-tai District, Beijing, 100069, China, 86 10 8391 1766, helenywu@vip.163.com %K mobile health %K coronary heart disease %K quality of life %K anxiety %K depression %K meta-analysis %K mobile phone %D 2024 %7 11.6.2024 %9 Review %J J Med Internet Res %G English %X Background: Coronary heart disease (CHD) is the leading cause of death globally. In addition, 20% to 40% of the patients with CHD have comorbid mental health issues such as anxiety or depression, affecting the prognosis and quality of life (QoL). Mobile health (mHealth) interventions have been developed and are widely used; however, the evidence for the effects of mHealth interventions on QoL, anxiety, and depression in patients with CHD is currently ambiguous. Objective: In this study, we aimed to assess the effects of mHealth interventions on QoL, anxiety, and depression in patients with CHD. Methods: We searched the Cochrane Library, PubMed, Embase, CINAHL, Web of Science, China National Knowledge Infrastructure, and Wanfang databases from inception to August 12, 2023. Eligible studies were randomized controlled trials that involved patients with CHD who received mHealth interventions and that reported on QoL, anxiety, or depression outcomes. We used the Cochrane risk-of-bias tool for randomized trials to evaluate the risk of bias in the studies, ensuring a rigorous and methodologically sound analysis. Review Manager (desktop version 5.4; The Cochrane Collaboration) and Stata MP (version 17.0; StataCorp LLC) were used to conduct the meta-analysis. The effect size was calculated using the standardized mean difference (SMD) and its 95% CI. Results: The meta-analysis included 23 studies (5406 participants in total) and showed that mHealth interventions significantly improved QoL in patients with CHD (SMD 0.49, 95% CI 0.25-0.72; Z=4.07; P<.001) as well as relieved their anxiety (SMD −0.46, 95% CI −0.83 to −0.08; Z=2.38; P=.02) and depression (SMD −0.34, 95% CI −0.56 to −0.12; Z=3.00; P=.003) compared to usual care. The subgroup analyses indicated a significant effect favoring the mHealth intervention on reducing anxiety and depressive symptoms compared to usual care, especially when (1) the intervention duration was ≥6 months (P=.04 and P=.001), (2) the mHealth intervention was a simple one (only 1 mHealth intervention was used) (P=.01 and P<.001), (3) it was implemented during the COVID-19 pandemic (P=.04 and P=.01), (4) it was implemented in low- or middle-income countries (P=.01 and P=.02), (5) the intervention focused on mental health (P=.01 and P=.007), and (6) adherence rates were high (≥90%; P=.03 and P=.002). In addition, comparing mHealth interventions to usual care, there was an improvement in QoL when (1) the mHealth intervention was a simple one (P<.001), (2) it was implemented in low- or middle-income countries (P<.001), and (3) the intervention focused on mental health (P<.001). Conclusions: On the basis of the existing evidence, mHealth interventions might be effective in improving QoL and reducing anxiety and depression in patients with CHD. However, large sample, high-quality, and rigorously designed randomized controlled trials are needed to provide further evidence. Trial Registration: PROSPERO CRD42022383858; https://tinyurl.com/3ea2npxf %M 38861710 %R 10.2196/52341 %U https://www.jmir.org/2024/1/e52341 %U https://doi.org/10.2196/52341 %U http://www.ncbi.nlm.nih.gov/pubmed/38861710 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e54739 %T A Multicomponent Intervention (POSSIBLE) to Improve Perceived Risk for HIV Among Black Sexual Minority Men: Feasibility and Preliminary Effectiveness Pilot Study %A Dangerfield II,Derek T %A Anderson,Janeane N %A Wylie,Charleen %A Bluthenthal,Ricky %A Beyrer,Chris %A Farley,Jason E %+ Milken Institute School of Public Health, George Washington University, 950 New Hampshire Avenue NW #308, Washington, DC, 20037, United States, 1 6673555188, ddanger2@gwu.edu %K pre-exposure prophylaxis %K PrEP %K sexual health %K peers %K apps %K community %K mobile phone %K HIV %K sexual minority %K minority communities %K minority %K Black %K African American %K peers %K patient education %K self-monitoring %K treatment adherence %K treatment participation %K community %K community health %K mobile health %K digital health %K digital technology %K digital interventions %K smartphones %D 2024 %7 11.6.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Increased pre-exposure prophylaxis (PrEP) use is urgently needed to substantially decrease HIV incidence among Black sexual minority men. Low perceived risk for HIV (PRH) is a key unaddressed PrEP barrier for Black sexual minority men. Peers and smartphone apps are popular intervention tools to promote community health behaviors, but few studies have used these together in a multicomponent strategy. Therefore, we designed a multicomponent intervention called POSSIBLE that used an existing smartphone app called PrEPme (Emocha Mobile Health, Inc) and a peer change agent (PCA) to increase PRH as a gateway to PrEP. Objective: This paper aims to describe the feasibility and preliminary impact of POSSIBLE on PRH and willingness to accept a PrEP referral among Black sexual minority men. Methods: POSSIBLE was a theoretically guided, single-group, 2-session pilot study conducted among Black sexual minority men from Baltimore, Maryland between 2019 and 2021 (N=69). POSSIBLE integrated a PCA and the PrEPme app that allows users to self-monitor sexual risk behaviors and chat with the in-app community health worker to obtain PrEP service information. PRH was assessed using the 8-item PRH scale before and after baseline and follow-up study visits. At the end of each study visit, the PCA referred interested individuals to the community health worker to learn more about PrEP service options. Results: The average age of participants was 32.5 (SD 8.1, range 19-62) years. In total, 55 (80%) participants were retained for follow-up at month 1. After baseline sessions, 29 (42%) participants were willing to be referred to PrEP services, 20 (69%) of those confirmed scheduled appointments with PrEP care teams. There were no statistically significant differences in PRH between baseline and follow-up visits (t122=–1.36; P=.17). Conclusions: We observed no statistically significant improvement in PRH between baseline and month 1. However, given the high retention rate and acceptability, POSSIBLE may be feasible to implement. Future research should test a statistically powered peer-based approach on PrEP initiation among Black sexual minority men. Trial Registration: ClinicalTrials.gov NCT04533386; https://clinicaltrials.gov/study/NCT04533386 %M 38861707 %R 10.2196/54739 %U https://humanfactors.jmir.org/2024/1/e54739 %U https://doi.org/10.2196/54739 %U http://www.ncbi.nlm.nih.gov/pubmed/38861707 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e49669 %T Just-in-Time Adaptive Intervention for Stabilizing Sleep Hours of Japanese Workers: Microrandomized Trial %A Takeuchi,Hiroki %A Ishizawa,Tetsuro %A Kishi,Akifumi %A Nakamura,Toru %A Yoshiuchi,Kazuhiro %A Yamamoto,Yoshiharu %+ Graduate School of Education, The University of Tokyo, Bunkyo-ku Hongo 7-3-1, Tokyo, 113-8654, Japan, 81 03 5841 3981, takeuchi@p.u-tokyo.ac.jp %K objective push-type sleep feedback %K stability of habitual sleep behaviors %K just-in-time adaptive intervention %K microrandomized trial %K mobile phone %D 2024 %7 11.6.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Sleep disturbance is a major contributor to future health and occupational issues. Mobile health can provide interventions that address adverse health behaviors for individuals in a vulnerable health state in real-world settings (just-in-time adaptive intervention). Objective: This study aims to identify a subpopulation with vulnerable sleep state in daily life (study 1) and, immediately afterward, to test whether providing mobile health intervention improved habitual sleep behaviors and psychological wellness in real-world settings by conducting a microrandomized trial (study 2). Methods: Japanese workers (n=182) were instructed to collect data on their habitual sleep behaviors and momentary symptoms (including depressive mood, anxiety, and subjective sleep quality) using digital devices in a real-world setting. In study 1, we calculated intraindividual mean and variability of sleep hours, midpoint of sleep, and sleep efficiency to characterize their habitual sleep behaviors. In study 2, we designed and conducted a sleep just-in-time adaptive intervention, which delivered objective push-type sleep feedback messages to improve their sleep hours for a subset of participants in study 1 (n=81). The feedback messages were generated based on their sleep data measured on previous nights and were randomly sent to participants with a 50% chance for each day (microrandomization). Results: In study 1, we applied hierarchical clustering to dichotomize the population into 2 clusters (group A and group B) and found that group B was characterized by unstable habitual sleep behaviors (large intraindividual variabilities). In addition, linear mixed-effect models showed that the interindividual variability of sleep hours was significantly associated with depressive mood (β=3.83; P=.004), anxiety (β=5.70; P=.03), and subjective sleep quality (β=−3.37; P=.03). In study 2, we found that providing sleep feedback prolonged subsequent sleep hours (increasing up to 40 min; P=.01), and this effect lasted for up to 7 days. Overall, the stability of sleep hours in study 2 was significantly improved among participants in group B compared with the participants in study 1 (P=.001). Conclusions: This is the first study to demonstrate that providing sleep feedback can benefit the modification of habitual sleep behaviors in a microrandomized trial. The findings of this study encourage the use of digitalized health intervention that uses real-time health monitoring and personalized feedback. %M 38861313 %R 10.2196/49669 %U https://www.jmir.org/2024/1/e49669 %U https://doi.org/10.2196/49669 %U http://www.ncbi.nlm.nih.gov/pubmed/38861313 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e54207 %T Leveraging Ecological Momentary Assessment Data to Characterize Individual Mobility: Exploratory Pilot Study in Rural Uganda %A Khalifa,Aleya %A Beres,Laura K %A Anok,Aggrey %A Mbabali,Ismail %A Katabalwa,Charles %A Mulamba,Jeremiah %A Thomas,Alvin G %A Bugos,Eva %A Nakigozi,Gertrude %A Chang,Larry W %A Grabowski,M Kate %+ Department of Epidemiology, Mailman School of Public Health, Columbia University, 722 W 168th St, New York, NY, 10032, United States, 1 212 305 2862, ak4598@cumc.columbia.edu %K ecological momentary assessment %K spatial analysis %K geographic mobility %K global positioning system %K health behaviors %K Uganda %K mobility %K pilot study %K smartphone %K alcohol %K cigarette %K smoking %K promoting %K promotion %K alcohol use %K cigarette smoking %K mobile phone %D 2024 %7 10.6.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: The geographical environments within which individuals conduct their daily activities may influence health behaviors, yet little is known about individual-level geographic mobility and specific, linked behaviors in rural low- and middle-income settings. Objective: Nested in a 3-month ecological momentary assessment intervention pilot trial, this study aims to leverage mobile health app user GPS data to examine activity space through individual spatial mobility and locations of reported health behaviors in relation to their homes. Methods: Pilot trial participants were recruited from the Rakai Community Cohort Study—an ongoing population-based cohort study in rural south-central Uganda. Participants used a smartphone app that logged their GPS coordinates every 1-2 hours for approximately 90 days. They also reported specific health behaviors (alcohol use, cigarette smoking, and having condomless sex with a non–long-term partner) via the app that were both location and time stamped. In this substudy, we characterized participant mobility using 3 measures: average distance (kilometers) traveled per week, number of unique locations visited (deduplicated points within 25 m of one another), and the percentage of GPS points recorded away from home. The latter measure was calculated using home buffer regions of 100 m, 400 m, and 800 m. We also evaluated the number of unique locations visited for each specific health behavior, and whether those locations were within or outside the home buffer regions. Sociodemographic information, mobility measures, and locations of health behaviors were summarized across the sample using descriptive statistics. Results: Of the 46 participants with complete GPS data, 24 (52%) participants were men, 30 (65%) participants were younger than 35 years, and 33 (72%) participants were in the top 2 socioeconomic status quartiles. On median, participants traveled 303 (IQR 152-585) km per week. Over the study period, participants on median recorded 1292 (IQR 963-2137) GPS points—76% (IQR 58%-86%) of which were outside their 400-m home buffer regions. Of the participants reporting drinking alcohol, cigarette smoking, and engaging in condomless sex, respectively, 19 (83%), 8 (89%), and 12 (86%) reported that behavior at least once outside their 400-m home neighborhood and across a median of 3.0 (IQR 1.5-5.5), 3.0 (IQR 1.0-3.0), and 3.5 (IQR 1.0-7.0) unique locations, respectively. Conclusions: Among residents in rural Uganda, an ecological momentary assessment app successfully captured high mobility and health-related behaviors across multiple locations. Our findings suggest that future mobile health interventions in similar settings can benefit from integrating spatial data collection using the GPS technology in mobile phones. Leveraging such individual-level GPS data can inform place-based strategies within these interventions for promoting healthy behavior change. %M 38857493 %R 10.2196/54207 %U https://formative.jmir.org/2024/1/e54207 %U https://doi.org/10.2196/54207 %U http://www.ncbi.nlm.nih.gov/pubmed/38857493 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e56373 %T An App-Based Physical Activity Intervention in Community-Dwelling Chinese-, Tagalog-, and Vietnamese-Speaking Americans: Single-Arm Intervention Study %A Nguyen,Antony %A Yu,Filmer %A Park,Linda G %A Fukuoka,Yoshimi %A Wong,Ching %A Gildengorin,Ginny %A Nguyen,Tung T %A Tsoh,Janice Y %A Jih,Jane %+ Division of General Internal Medicine, University of California San Francisco, 490 Illinois Street, San Francisco, CA, 94158, United States, 1 4158857563, jane.jih@ucsf.edu %K physical activity %K mHealth %K mobile health %K mobile app %K Asian Americans %K physical activity tracker %K mobile phone %K app %K apps %K application %K applications %K app-based %K intervention %K interventions %K community-dwelling %K tracker %K trackers %K pilot study %K feasibility %K acceptability %K cultural %K culturally %K linguistic %K linguistically %K evidence-based %K community-based %K sociodemographic %K lifestyle %K Chinese %K Vietnamese %K Filipino %K adult %K adults %K multicomponent %K multilingual %D 2024 %7 10.6.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Physical inactivity is associated with adverse health outcomes among Asian Americans, who exhibit the least adherence to physical activity guidelines compared with other racial and ethnic groups. Mobile app–based interventions are a promising approach to promote healthy behaviors. However, there is a lack of app-based interventions focused on improving physical activity among Asian Americans whose primary language is not English. Objective: This pilot study aimed to assess the feasibility and acceptability of a 5-week intervention using a culturally and linguistically adapted, evidence-based mobile phone app with an accelerometer program, to promote physical activity among Chinese-, Tagalog-, or Vietnamese-speaking Americans. Methods: Participants were recruited through collaborations with community-based organizations. The intervention was adapted from a 12-month physical activity randomized controlled trial involving the app and accelerometer for English-speaking adults. Sociodemographic characteristics, lifestyle factors, and physical measurements were collected at the baseline visit. A 7-day run-in period was conducted to screen for the participants who could wear a Fitbit One (Fitbit LLC) accelerometer and complete the app’s daily step diary. During the 4-week intervention period, participants wore the accelerometer and reported their daily steps in the app. Participants also received daily messages to reinforce key contents taught during an in-person educational session, remind them to input steps, and provide tailored feedback. Feasibility measures were the percentage of eligible participants completing the run-in period and the percentage of participants who used the app diary for at least 5 out of 7 days during the intervention period. We conducted poststudy participant interviews to explore overall intervention acceptability. Results: A total of 19 participants were enrolled at the beginning of the study with a mean age of 47 (SD 13.3; range 29-70) years, and 58% (n=11) of them were female. Of the participants, 26% (n=5) were Chinese, 32% (n=6) were Vietnamese, and 42% (n=8) were Filipino. All participants met the run-in criteria to proceed with the intervention. Adherence to the app diary ranged from 74% (n=14) in week 2 to 95% (n=18) in week 4. The daily average steps per week from accelerometers increased each week from 8451 (SD 3378) steps during the run-in period to 10,930 (SD 4213) steps in week 4. Participants reported positive experiences including an increased motivation to walk and the enjoyment of being able to monitor their physical activity. Conclusions: This is the first pilot study of a multicomponent intervention and evidence-based mobile phone app to promote physical activity among Asian Americans who use apps in traditional Chinese, Tagalog, or Vietnamese, which demonstrated high feasibility and acceptability. Future work focused on multilingual mobile apps to address disparities in physical inactivity among Asian Americans should be considered. %M 38857065 %R 10.2196/56373 %U https://formative.jmir.org/2024/1/e56373 %U https://doi.org/10.2196/56373 %U http://www.ncbi.nlm.nih.gov/pubmed/38857065 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e45469 %T App Engagement as a Predictor of Weight Loss in Blended-Care Interventions: Retrospective Observational Study Using Large-Scale Real-World Data %A Lehmann,Marco %A Jones,Lucy %A Schirmann,Felix %+ Oviva AG, Dortustraße 48, Potsdam, 14467, Germany, 49 3055572034, marco.lehmann@oviva.com %K obesity %K weight loss %K blended-care %K digital health %K real-world data %K app engagement %K mHealth %K mobile health %K technology engagement %K weight management %K mobile phone %D 2024 %7 7.6.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Early weight loss is an established predictor for treatment outcomes in weight management interventions for people with obesity. However, there is a paucity of additional, reliable, and clinically actionable early predictors in weight management interventions. Novel blended-care weight management interventions combine coach and app support and afford new means of structured, continuous data collection, informing research on treatment adherence and outcome prediction. Objective: Against this backdrop, this study analyzes app engagement as a predictor for weight loss in large-scale, real-world, blended-care interventions. We hypothesize that patients who engage more frequently in app usage in blended-care treatment (eg, higher logging activity) lose more weight than patients who engage comparably less frequently at 3 and 6 months of intervention. Methods: Real-world data from 19,211 patients in obesity treatment were analyzed retrospectively. Patients were treated with 3 different blended-care weight management interventions, offered in Switzerland, the United Kingdom, and Germany by a digital behavior change provider. The principal component analysis identified an overarching metric for app engagement based on app usage. A median split informed a distinction in higher and lower engagers among the patients. Both groups were matched through optimal propensity score matching for relevant characteristics (eg, gender, age, and start weight). A linear regression model, combining patient characteristics and app-derived data, was applied to identify predictors for weight loss outcomes. Results: For the entire sample (N=19,211), mean weight loss was –3.24% (SD 4.58%) at 3 months and –5.22% (SD 6.29%) at 6 months. Across countries, higher app engagement yielded more weight loss than lower engagement after 3 but not after 6 months of intervention (P3 months<.001 and P6 months=.59). Early app engagement within the first 3 months predicted percentage weight loss in Switzerland and Germany, but not in the United Kingdom (PSwitzerland<.001, PUnited Kingdom=.12, and PGermany=.005). Higher age was associated with stronger weight loss in the 3-month period (PSwitzerland=.001, PUnited Kingdom=.002, and PGermany<.001) and, for Germany, also in the 6-month period (PSwitzerland=.09, PUnited Kingdom=.46, and PGermany=.03). In Switzerland, higher numbers of patients’ messages to coaches were associated with higher weight loss (P3 months<.001 and P6 months<.001). Messages from coaches were not significantly associated with weight loss (all P>.05). Conclusions: Early app engagement is a predictor of weight loss, with higher engagement yielding more weight loss than lower engagement in this analysis. This new predictor lends itself to automated monitoring and as a digital indicator for needed or adapted clinical action. Further research needs to establish the reliability of early app engagement as a predictor for treatment adherence and outcomes. In general, the obtained results testify to the potential of app-derived data to inform clinical monitoring practices and intervention design. %M 38848556 %R 10.2196/45469 %U https://www.jmir.org/2024/1/e45469 %U https://doi.org/10.2196/45469 %U http://www.ncbi.nlm.nih.gov/pubmed/38848556 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e56003 %T Smartphone-Based Survey and Message Compliance in Adults Initially Unready to Quit Smoking: Secondary Analysis of a Randomized Controlled Trial %A Ulm,Clayton %A Chen,Sixia %A Fleshman,Brianna %A Benson,Lizbeth %A Kendzor,Darla E %A Frank-Pearce,Summer %A Neil,Jordan M %A Vidrine,Damon %A De La Torre,Irene %A Businelle,Michael S %+ TSET Health Promotion Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, 655 Research Parkway, Suite 400, Oklahoma City, OK, 73104, United States, 1 405 271 8001, michael-businelle@ouhsc.edu %K just-in-time adaptive intervention %K tailored messaging %K smoking cessation %K mobile health %K survey compliance %K phase-based model %K smoking %K smoker %K survey %K smokers %K messaging %K smartphone %K efficacy %K pilot randomized controlled trial %K adult smokers %K linear regression %K age %K intervention engagement %K engagement %D 2024 %7 7.6.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Efficacy of smartphone-based interventions depends on intervention content quality and level of exposure to that content. Smartphone-based survey completion rates tend to decline over time; however, few studies have identified variables that predict this decline over longer-term interventions (eg, 26 weeks). Objective: This study aims to identify predictors of survey completion and message viewing over time within a 26-week smoking cessation trial. Methods: This study examined data from a 3-group pilot randomized controlled trial of adults who smoke (N=152) and were not ready to quit smoking within the next 30 days. For 182 days, two intervention groups received smartphone-based morning and evening messages based on current readiness to quit smoking. The control group received 2 daily messages unrelated to smoking. All participants were prompted to complete 26 weekly smartphone-based surveys that assessed smoking behavior, quit attempts, and readiness to quit. Compliance was operationalized as percentages of weekly surveys completed and daily messages viewed. Linear regression and mixed-effects models were used to identify predictors (eg, intervention group, age, and sex) of weekly survey completion and daily message viewing and decline in compliance over time. Results: The sample (mean age 50, SD 12.5, range 19-75 years; mean years of education 13.3, SD 1.6, range 10-20 years) was 67.8% (n=103) female, 74.3% (n=113) White, 77% (n=117) urban, and 52.6% (n=80) unemployed, and 61.2% (n=93) had mental health diagnoses. On average, participants completed 18.3 (71.8%) out of 25.5 prompted weekly surveys and viewed 207.3 (60.6%) out of 345.1 presented messages (31,503/52,460 total). Age was positively associated with overall weekly survey completion (P=.003) and daily message viewing (P=.02). Mixed-effects models indicated a decline in survey completion from 77% (114/148) in the first week of the intervention to 56% (84/150) in the last week of the intervention (P<.001), which was significantly moderated by age, sex, ethnicity, municipality (ie, rural/urban), and employment status. Similarly, message viewing declined from 72.3% (1533/2120) in the first week of the intervention to 44.6% (868/1946) in the last week of the intervention (P<.001). This decline in message viewing was significantly moderated by age, sex, municipality, employment status, and education. Conclusions: This study demonstrated the feasibility of a 26-week smartphone-based smoking cessation intervention. Study results identified subgroups that displayed accelerated rates in the decline of survey completion and message viewing. Future research should identify ways to maintain high levels of interaction with mobile health interventions that span long intervention periods, especially among subgroups that have demonstrated declining rates of intervention engagement over time. Trial Registration: ClinicalTrials.gov NCT03405129; https://clinicaltrials.gov/ct2/show/NCT03405129 %M 38848557 %R 10.2196/56003 %U https://formative.jmir.org/2024/1/e56003 %U https://doi.org/10.2196/56003 %U http://www.ncbi.nlm.nih.gov/pubmed/38848557 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e48520 %T mHealth Intervention for Elevated Blood Pressure Among College Students: Single-Arm Intervention Study %A Tran,Dieu-My %A Dingley,Catherine %A Bonilla,Roger %+ School of Nursing, University of Nevada, Las Vegas, 4505 S. Maryland Parkway, Box 453018, Las Vegas, NV, 89154, United States, 1 7028951220, dieu-my.tran@unlv.edu %K blood pressure %K mHealth %K self-management %K students %K intervention %K elevated blood pressure %K college %K hypertension %K young adult %K mobile app %K smartphone %K monitoring %K text messaging %K text mining %D 2024 %7 7.6.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Current evidence reveals a growing pattern of hypertension among young adults, significantly increasing their risk for cardiovascular disease later in life. Young adults, particularly those of college age, often develop risk factors related to lifestyle choices in diet, exercise, and alcohol consumption. Developing useful interventions that can assist with screening and possible behavioral modifications that are suitable and appealing to college-aged young adults could help with early identification and intervention for hypertension. Recent studies indicate mobile health (mHealth) apps are acceptable and effective for communication and message delivery among this population. Objective: The purpose of this study was to examine the feasibility of using a mobile smartphone delivery system that provides tailored messages based on participant self-measured blood pressure (BP) with college-aged young adults. Methods: Using a single-arm intervention, pilot study design, the mHealth to Optimize BP Improvement (MOBILE) intervention was implemented with college students aged 18 years to 39 years who had systolic BP >120 mm Hg and diastolic BP ≥80 mm Hg. Participants were required to measure their BP daily for 28 days, submit the readings to the app, and receive preset educational text messages tailored to their BP value and related to encouraging healthy lifestyle modifications. Changes in a participant’s BP was evaluated using a mixed regression model, and a postintervention survey evaluated their perspectives on the mHealth intervention. Results: The participants’ (N=9) mean age was 22.64 (SD 4.54) years; 56% (5/9) were overweight, and 11% (1/9) were obese. The average daily participation rate was 86%. Of the 9 participants, 8 completed the survey, and all indicated the intervention was easy to use, found it increased awareness of their individual BP levels, indicated the text messages were helpful, and reported making lifestyle changes based on the study intervention. They also provided suggestions for future implementation of the intervention and program. Overall, no significant changes were noted in BP over the 28 days. Conclusions: The mHealth-supported MOBILE intervention for BP monitoring and tailored text messaging was feasible to implement, as our study indicated high rates of participation and acceptability. These encouraging findings support further development and testing in a larger sample over a longer time frame and hold the potential for early identification and intervention among college-aged adults, filling a gap in current research. %M 38848120 %R 10.2196/48520 %U https://formative.jmir.org/2024/1/e48520 %U https://doi.org/10.2196/48520 %U http://www.ncbi.nlm.nih.gov/pubmed/38848120 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e50107 %T Smartwatch-Based Interventions for People With Dementia: User-Centered Design Approach %A Goerss,Doreen %A Köhler,Stefanie %A Rong,Eleonora %A Temp,Anna Gesine %A Kilimann,Ingo %A Bieber,Gerald %A Teipel,Stefan %+ Department of Psychosomatic Medicine, Rostock University Medical Center, Gehlsheimer Str. 20, Rostock, 18147, Germany, 49 3814949471, doreen.goerss@med.uni-rostock.de %K assistive technology %K user-centered design %K usability %K dementia %K smartwatch %K mobile phone %D 2024 %7 7.6.2024 %9 Original Paper %J JMIR Aging %G English %X Background: Assistive technologies can help people living with dementia maintain their everyday activities. Nevertheless, there is a gap between the potential and use of these materials. Involving future users may help close this gap, but the impact on people with dementia is unclear. Objective: We aimed to determine if user-centered development of smartwatch-based interventions together with people with dementia is feasible. In addition, we evaluated the extent to which user feedback is plausible and therefore helpful for technological improvements. Methods: We examined the interactions between smartwatches and people with dementia or people with mild cognitive impairment. All participants were prompted to complete 2 tasks (drinking water and a specific cognitive task). Prompts were triggered using a smartphone as a remote control and were repeated up to 3 times if participants failed to complete a task. Overall, 50% (20/40) of the participants received regular prompts, and 50% (20/40) received intensive audiovisual prompts to perform everyday tasks. Participants’ reactions were observed remotely via cameras. User feedback was captured via questionnaires, which included topics like usability, design, usefulness, and concerns. The internal consistency of the subscales was calculated. Plausibility was also checked using qualitative approaches. Results: Participants noted their preferences for particular functions and improvements. Patients struggled with rating using the Likert scale; therefore, we assisted them with completing the questionnaire. Usability (mean 78 out of 100, SD 15.22) and usefulness (mean 9 out of 12) were rated high. The smartwatch design was appealing to most participants (31/40, 76%). Only a few participants (6/40, 15%) were concerned about using the watch. Better usability was associated with better cognition. The observed success and self-rated task comprehension were in agreement for most participants (32/40, 80%). In different qualitative analyses, participants’ responses were, in most cases, plausible. Only 8% (3/40) of the participants were completely unaware of their irregular task performance. Conclusions: People with dementia can have positive experiences with smartwatches. Most people with dementia provided valuable information. Developing assistive technologies together with people with dementia can help to prioritize the future development of functional and nonfunctional features. %M 38848116 %R 10.2196/50107 %U https://aging.jmir.org/2024/1/e50107 %U https://doi.org/10.2196/50107 %U http://www.ncbi.nlm.nih.gov/pubmed/38848116 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53784 %T Feasibility of Web-Based Single-Session Empowered Relief in Patients With Chronic Pain Taking Methadone or Buprenorphine: Protocol for a Single-Arm Trial %A Klein,Morgan R %A Darnall,Beth D %A You,Dokyoung S %+ Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, 1070 Arastradero Rd, Suite 200, Palo Alto, CA, 94304, United States, 1 650 724 9320, dsyou@stanford.edu %K chronic pain %K opioid use disorder %K methadone %K buprenorphine %K behavioral medicine %K telehealth %K psychology %D 2024 %7 6.6.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic pain affects tens of millions of US adults and continues to rise in prevalence. Nonpharmacologic behavioral pain treatments are greatly needed and yet are often inaccessible, particularly in settings where medication prescribing is prioritized. Objective: This study aims to test the feasibility of a live-instructor, web-based 1-session pain relief skills class in an underserved and potentially at-risk population: people with chronic pain prescribed methadone or buprenorphine either solely for pain or for comorbid opioid use disorder (OUD). Methods: This is a national, prospective, single-arm, uncontrolled feasibility trial. The trial is untethered from medical care; to enhance participants’ willingness to join the study, no medical records or drug-monitoring records are accessed. At least 45 participants will be recruited from outpatient pain clinics and from an existing research database of individuals who have chronic pain and are taking methadone or buprenorphine. Patient-reported measures will be collected at 6 time points (baseline, immediately post treatment, 2 weeks, and months 1-3) via a web-based platform, paper, or phone formats to include individuals with limited internet or computer access and low literacy skills. At baseline, participants complete demographic questions and 13 study measures (Treatment Expectations, Body Pain Map, Medication Use, Pain Catastrophizing Scale [PCS], Patient-Reported Outcomes Measurement Information System [PROMIS] Measures, and Opioid Craving Scale). Immediately post treatment, a treatment satisfaction and acceptability measure is administered on a 0 (very dissatisfied) to 10 (completely satisfied) scale, with 3 of these items being the primary outcome (perceived usefulness, participant satisfaction, and likelihood of using the skills). At each remaining time point, the participants complete all study measures minus treatment expectations and satisfaction. Participants who do not have current OUD will be assessed for historical OUD, with presence of OUD (yes or no), and history of OUD (yes or no) reported separately. Feasibility threshold is set as an overall group treatment satisfaction rating of 8 of 10. In-depth qualitative interviews will be conducted with about 10 participants to obtain additional data on patient perceptions, satisfactions, needs, and wants. To assess preliminary efficacy, we will examine changes in pain catastrophizing, pain intensity, pain bothersomeness, sleep disturbance, pain interference, depression, anxiety, physical function, global impression of change, and opioid craving at 1 month post treatment. Results: This project opened to enrollment in September 2021 and completed the recruitment in October 2023. The data collection was completed in February 2024. Results are expected to be published in late 2024. Conclusions: Results from this trial will inform the feasibility and preliminary efficacy of Empowered Relief in this population and will inform the design of a future randomized controlled trial testing web-based Empowered Relief in chronic pain and comorbid OUD. Trial Registration: ClinicalTrials.gov NCT05057988; https://clinicaltrials.gov/study/NCT05057988 International Registered Report Identifier (IRRID): DERR1-10.2196/53784 %M 38843513 %R 10.2196/53784 %U https://www.researchprotocols.org/2024/1/e53784 %U https://doi.org/10.2196/53784 %U http://www.ncbi.nlm.nih.gov/pubmed/38843513 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e51708 %T Six-Month Outcomes of a Theory- and Technology-Enhanced Physical Activity Intervention for Latina Women (Pasos Hacia La Salud II): Randomized Controlled Trial %A Connell Bohlen,Lauren %A Dunsiger,Shira I %A von Ash,Tayla %A Larsen,Britta A %A Pekmezi,Dori %A Marquez,Becky %A Benitez,Tanya J %A Mendoza-Vasconez,Andrea %A Hartman,Sheri J %A Williams,David M %A Marcus,Bess H %+ Center for Health Promotion and Health Equity, Department of Behavioral and Social Sciences, Brown University School of Public Health, 121 South Main Street, Box G-S121-8, Providence, RI, 02912, United States, 1 4018636559, lauren_bohlen@brown.edu %K digital health %K web-based intervention %K exercise %K social support %K behavior change intervention %K support %K Latina women %K women %K Latina %K physical activity %K barrier %K aerobic %K remote intervention %K text message %K behavior change %K behavior %D 2024 %7 6.6.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: More than half (55%) of Latina women do not meet aerobic physical activity (PA) guidelines, and frequently cite time, childcare, and transportation as barriers to PA. In addition to linguistic adaptations for this population, successful PA interventions for Latina women addressed these barriers through remote intervention delivery approaches (eg, mail, phone, or web delivery). Objective: We aimed to evaluate 6-month outcomes of a randomized trial comparing a Spanish-language, individually tailored, web-delivered PA intervention (original) to an enhanced version with text messages and additional features (enhanced). Further, we evaluated if increases in PA at 6 months were moderated by baseline activity status. Methods: In total, 195 Latina women aged 18-65 years participated in a trial comparing the efficacy of the enhanced versus original interventions at initiating PA behavior change. We examined minutes per week of accelerometer-measured PA in the enhanced versus original arms, and the proportion of each arm meeting aerobic PA guidelines (150 min/wk at 6 mo). For moderator analyses, participants were classified as inactive (0 min/wk) or low active (1-90 min/wk) at baseline, measured via the 7 Day Physical Activity Recall interview. Results: PA increased from 19.7 (SD 47.9) minutes per week at baseline to 46.9 (SD 66.2) minutes per week at 6 months in the enhanced arm versus 20.6 (SD 42.7) minutes per week to 42.9 (SD 78.2) minutes per week in the original arm (P=.78). Overall, 30% (31/103) of the enhanced group met aerobic PA guidelines at 6 months, compared to 21% (19/92) of the original group (odds ratio [OR] 1.75, 95% CI 0.87-3.55). Baseline PA (inactive vs low active) moderated treatment effects on PA. For inactive participants, there were no group differences at 6 months (b=7.1; SE 22.8; P=.75), while low-active participants increased more in enhanced than original (b=72.5; SE 27.9; P=.01). For low-active participants, 45% (46/103) of the enhanced group met PA guidelines at 6 months, versus 20% (18/92) of the original arm (OR 3.29, 95% CI 1.05-11.31). For inactive participants, there were no group differences (25/103, 24% vs n=19/92, 21% for enhanced vs original, respectively; OR 1.28, 95% CI 0.54-3.06). Conclusions: Intervention effects were conditional on baseline PA. For low-active Latina women, the enhanced intervention was more effective at increasing PA. Additional tailored intervention enhancements may be necessary to increase PA for inactive Latina women. Trial Registration: ClinicalTrials.gov NCT03491592; https://www.clinicaltrials.gov/study/NCT03491592 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-022-06575-4 %M 38842930 %R 10.2196/51708 %U https://www.jmir.org/2024/1/e51708 %U https://doi.org/10.2196/51708 %U http://www.ncbi.nlm.nih.gov/pubmed/38842930 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e53406 %T Digital Lifestyle Interventions for Young People With Mental Illness: A Qualitative Study Among Mental Health Care Professionals %A Sawyer,Chelsea %A Carney,Rebekah %A Hassan,Lamiece %A Bucci,Sandra %A Sainsbury,John %A Lovell,Karina %A Torous,John %A Firth,Joseph %+ Division of Psychology and Mental Health, University of Manchester, 3.005 Jean Mcfarlane Building, Manchester, M13 9PL, United Kingdom, 44 161 306 7811, Joseph.firth@manchester.ac.uk %K digital health %K behavior change %K mental health care professionals %K physical health %K lifestyle intervention %K qualitative %K thematic analysis %K service optimization %K mobile phone %D 2024 %7 5.6.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Given the physical health disparities associated with mental illness, targeted lifestyle interventions are required to reduce the risk of cardiometabolic disease. Integrating physical health early in mental health treatment among young people is essential for preventing physical comorbidities, reducing health disparities, managing medication side effects, and improving overall health outcomes. Digital technology is increasingly used to promote fitness, lifestyle, and physical health among the general population. However, using these interventions to promote physical health within mental health care requires a nuanced understanding of the factors that affect their adoption and implementation. Objective: Using a qualitative design, we explored the attitudes of mental health care professionals (MHCPs) toward digital technologies for physical health with the goal of illuminating the opportunities, development, and implementation of the effective use of digital tools for promoting healthier lifestyles in mental health care. Methods: Semistructured interviews were conducted with MHCPs (N=13) using reflexive thematic analysis to explore their experiences and perspectives on using digital health to promote physical health in youth mental health care settings. Results: Three overarching themes from the qualitative analysis are reported: (1) motivation will affect implementation, (2) patients’ readiness and capability, and (3) reallocation of staff roles and responsibilities. The subthemes within, and supporting quotes, are described. Conclusions: The use of digital means presents many opportunities for improving the provision of physical health interventions in mental health care settings. However, given the limited experience of many MHCPs with these technologies, formal training and additional support may improve the likelihood of implementation. Factors such as patient symptomatology, safety, and access to technology, as well as the readiness, acceptability, and capability of both MHCPs and patients to engage with digital tools, must also be considered. In addition, the potential benefits of data integration must be carefully weighed against the associated risks. %M 38837191 %R 10.2196/53406 %U https://humanfactors.jmir.org/2024/1/e53406 %U https://doi.org/10.2196/53406 %U http://www.ncbi.nlm.nih.gov/pubmed/38837191 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e48092 %T Implementation of a Web-Based Outpatient Asynchronous Consultation Service: Mixed Methods Study %A Rzewuska Díaz,Magdalena %A Locock,Louise %A Keen,Andrew %A Melvin,Mike %A Myhill,Anthony %A Ramsay,Craig %+ Health Services Research Unit, University of Aberdeen, 2nd floor, Health Sciences Building, Aberdeen, AB252ZD, United Kingdom, 44 1224438148, magdalena.rzewuska@abdn.ac.uk %K outpatient care %K teleconsultation %K asynchronous communication %K implementation %K mixed methods research %K qualitative research %K hospital data %D 2024 %7 4.6.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Asynchronous outpatient patient-to-provider communication is expanding in UK health care, requiring evaluation. During the pandemic, Aberdeen Royal Infirmary in Scotland expanded its outpatient asynchronous consultation service from dermatology (deployed in May 2020) to gastroenterology and pain management clinics. Objective: We conducted a mixed methods study using staff, patient, and public perspectives and National Health Service (NHS) numerical data to obtain a rounded picture of innovation as it happened. Methods: Focus groups (3 web-based and 1 face-to-face; n=22) assessed public readiness for this service, and 14 interviews with staff focused on service design and delivery. The service’s effects were examined using NHS Grampian service use data, a patient satisfaction survey (n=66), and 6 follow-up patient interviews. Survey responses were descriptively analyzed. Demographics, acceptability, nonattendance rates, and appointment outcomes of users were compared across levels of area deprivation in which they live and medical specialties. Interviews and focus groups underwent theory-informed thematic analysis. Results: Staff anticipated a simple technical system transfer from dermatology to other receptive medical specialties, but despite a favorable setting and organizational assistance, it was complicated. Key implementation difficulties included pandemic-induced technical integration delays, misalignment with existing administrative processes, and discontinuity in project management. The pain management clinic began asynchronous consultations (digital appointments) in December 2021, followed by the gastroenterology clinic in February 2022. Staff quickly learned how to explain and use this service. It was thought to function better for pain management as it fitted preexisting practices. From May to September 2022, the dermatology (adult and pediatric), gastroenterology, and pain management clinics offered 1709 appointments to a range of patients (n=1417). Digital appointments reduced travel by an estimated 44,712 miles (~71,956.81 km) compared to the face-to-face mode. The deprivation profile of people who chose to use this service closely mirrored that of NHS Grampian’s population overall. There was no evidence that deprivation impacted whether digital appointment users subsequently received treatment. Only 18% (12/66) of survey respondents were unhappy or very unhappy with being offered a digital appointment. The benefits mentioned included better access, convenience, decreased travel and waiting time, information sharing, and clinical flexibility. Overall, patients, the public, and staff recognized its potential as an NHS service but highlighted informed choice and flexibility. Better communication—including the use of the term assessment instead of appointment—may increase patient acceptance. Conclusions: Asynchronous pain management and gastroenterology consultations are viable and acceptable. Implementing this service is easiest when existing administrative processes face minimal disruption, although continuous support is needed. This study can inform practical strategies for supporting staff in adopting asynchronous consultations (eg, preparing for nonlinearity and addressing task issues). Patients need clear explanations and access to technical support, along with varied consultation options, to ensure digital inclusion. %M 38833695 %R 10.2196/48092 %U https://www.jmir.org/2024/1/e48092 %U https://doi.org/10.2196/48092 %U http://www.ncbi.nlm.nih.gov/pubmed/38833695 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e50783 %T Effects of the “AI-TA” Mobile App With Intelligent Design on Psychological and Related Symptoms of Young Survivors of Breast Cancer: Randomized Controlled Trial %A Jiang,Lulu %A Xu,Jiehui %A Wu,Yanwei %A Liu,Yanyan %A Wang,Xiyi %A Hu,Yun %+ School of Nursing, Shanghai Jiao Tong University, No.277 Chongqing South Roud, Huangpu District, Shanghai, 200025, China, 86 021 63546078, huyunsy@shsmu.edu.cn %K mobile app %K artificial intelligence %K interactivity %K breast cancer %K psychological symptoms %K self-efficacy %K social support %K quality of life %D 2024 %7 4.6.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Young women often face substantial psychological challenges in the initial years following cancer diagnosis, leading to a comparatively lower quality of life than older survivors. While mobile apps have emerged as potential interventions, their effectiveness remains inconclusive due to the diversity in intervention types and variation in follow-up periods. Furthermore, there is a particular dearth of evidence regarding the efficacy of these apps’ intelligent features in addressing psychological distress with these apps. Objective: This study aims to evaluate the effectiveness of a mobile app with intelligent design called “AI-TA” on cancer-related psychological health and ongoing symptoms with a randomized controlled design. Methods: Women aged 18 to 45 years diagnosed with breast cancer were randomly assigned to the intervention or control group. The intervention was AI-TA, which included 2-way web-based follow-up every 2 weeks. Both intention-to-treat (ITT) and per-protocol (PP) analyses employed repeated measurement analysis of variance. The participants’ background features, primary outcomes (psychological distress and frequency, self-efficacy, and social support), and secondary outcomes (quality of life) were measured using multiple instruments at 3 time points (baseline, 1-month intervention, and 3-month intervention). Results: A total of 124 participants were randomly allocated to the control group (n=62, 50%) or intervention group (n=62, 50%). In total, 92.7% (115/124) of the participants completed the intervention. Significant improvements in psychological symptoms (Memorial Symptom Assessment Scale-Short Form) were observed in the ITT group from baseline to 1-month intervention relative to the control group (ITT vs control: 1.17 vs 1.23; P<.001), which persisted at 3-month follow-up (ITT vs control: 0.68 vs 0.91; P<.001). Both the ITT and PP groups exhibited greater improvements in self-efficacy (Cancer Behavior Inventory-Brief Version) than the control group at 1-month (ITT vs PP vs control: 82.83 vs 77.12 vs 65.35; P<.001) and 3-month intervention (ITT vs PP vs control: 92.83 vs 89.30 vs 85.65; P<.001). However, the change in social support (Social Support Rating Scale) did not increase significantly until 3-month intervention (ITT vs control: 50.09 vs 45.10; P=.002) (PP vs control: 49.78 vs 45.10; P<.001). All groups also experienced beneficial effects on quality of life (Functional Assessment of Cancer Therapy-Breast), which persisted at 3-month follow-up (P<.001). Conclusions: The intelligent mobile app AI-TA incorporating intelligent design shows promise for reducing psychological and cancer-related symptoms among young survivors of breast cancer. Trial Registration: Chinese Clinical Trial Registry ChiCTR2200058823; https://www.chictr.org.cn/showproj.html?proj=151195 %M 38833298 %R 10.2196/50783 %U https://mhealth.jmir.org/2024/1/e50783 %U https://doi.org/10.2196/50783 %U http://www.ncbi.nlm.nih.gov/pubmed/38833298 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e44443 %T Mental Wellness Self-Care in Singapore With mindline.sg: A Tutorial on the Development of a Digital Mental Health Platform for Behavior Change %A Weng,Janice Huiqin %A Hu,Yanyan %A Heaukulani,Creighton %A Tan,Clarence %A Chang,Julian Kuiyu %A Phang,Ye Sheng %A Rajendram,Priyanka %A Tan,Weng Mooi %A Loke,Wai Chiong %A Morris,Robert J T %+ MOH Office for Healthcare Transformation, 1 Maritime Square, Harbourfront Centre, Singapore, 099253, Singapore, 65 66793209, creighton.heaukulani@moht.com.sg %K digital mental health %K artificial intelligence %K AI %K AI chatbot %K digital therapeutics %K mental health %K mental wellness %K mobile phone %D 2024 %7 4.6.2024 %9 Tutorial %J J Med Internet Res %G English %X Background: Singapore, like the rest of Asia, faces persistent challenges to mental health promotion, including stigma around unwellness and seeking treatment and a lack of trained mental health personnel. The COVID-19 pandemic, which created a surge in mental health care needs and simultaneously accelerated the adoption of digital health solutions, revealed a new opportunity to quickly scale innovative solutions in the region. Objective: In June 2020, the Singaporean government launched mindline.sg, an anonymous digital mental health resource website that has grown to include >500 curated local mental health resources, a clinically validated self-assessment tool for depression and anxiety, an artificial intelligence (AI) chatbot from Wysa designed to deliver digital therapeutic exercises, and a tailored version of the website for working adults called mindline at work. The goal of the platform is to empower Singapore residents to take charge of their own mental health and to be able to offer basic support to those around them through the ease and convenience of a barrier-free digital solution. Methods: Website use is measured through click-level data analytics captured via Google Analytics and custom application programming interfaces, which in turn drive a customized analytics infrastructure based on the open-source platforms Titanium Database and Metabase. Unique, nonbounced (users that do not immediately navigate away from the site), engaged, and return users are reported. Results: In the 2 years following launch (July 1, 2020, through June 30, 2022), the website received >447,000 visitors (approximately 15% of the target population of 3 million), 62.02% (277,727/447,783) of whom explored the site or engaged with resources (referred to as nonbounced visitors); 10.54% (29,271/277,727) of those nonbounced visitors returned. The most popular features on the platform were the dialogue-based therapeutic exercises delivered by the chatbot and the self-assessment tool, which were used by 25.54% (67,626/264,758) and 11.69% (32,469/277,727) of nonbounced visitors. On mindline at work, the rates of nonbounced visitors who engaged extensively (ie, spent ≥40 seconds exploring resources) and who returned were 51.56% (22,474/43,588) and 13.43% (5,853/43,588) over a year, respectively, compared to 30.9% (42,829/138,626) and 9.97% (13,822/138,626), respectively, on the generic mindline.sg site in the same year. Conclusions: The site has achieved desired reach and has seen a strong growth rate in the number of visitors, which required substantial and sustained digital marketing campaigns and strategic outreach partnerships. The site was careful to preserve anonymity, limiting the detail of analytics. The good levels of overall adoption encourage us to believe that mild to moderate mental health conditions and the social factors that underly them are amenable to digital interventions. While mindline.sg was primarily used in Singapore, we believe that similar solutions with local customization are widely and globally applicable. %M 38833294 %R 10.2196/44443 %U https://www.jmir.org/2024/1/e44443 %U https://doi.org/10.2196/44443 %U http://www.ncbi.nlm.nih.gov/pubmed/38833294 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e50024 %T A Web-Based Training Program for School Staff to Respond to Self-Harm: Design and Development of the Supportive Response to Self-Harm Program %A Burn,Anne-Marie %A Hall,Poppy %A Anderson,Joanna %+ Department of Psychiatry, University of Cambridge, Herchel Smith Building for Brain and Mind Sciences, Forvie Site, Robinson Way, Cambridge, CB2 0SZ, United Kingdom, 44 1223336961, amb278@cam.ac.uk %K self-harm %K schools %K young people %K youth %K school staff %K training %K coproduction %K qualitative %D 2024 %7 4.6.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Self-harm is common among adolescents and is a major public health concern. School staff may be the first adults to notice a young person’s self-harm and are well placed to provide support or signpost students to help. However, school staff often report that they do not feel equipped or confident to support students. Despite the need, there is a lack of evidence-based training about self-harm for school staff. A web-based training program would provide schools with a flexible and cost-effective method of increasing staff knowledge, skills, and confidence in how to respond to students who self-harm. Objective: The main objective of this study was to coproduce an evidence-based training program for school staff to improve their skills and confidence in responding to students who self-harm (Supportive Response to Self-Harm [SORTS]). This paper describes the design and development process of an initial prototype coproduced with stakeholders to ensure that the intervention meets their requirements. Methods: Using a user-centered design and person-based approach, the SORTS prototype was informed by (1) a review of research literature, existing guidelines, and policies; (2) coproduction discussions with the technical provider and subject matter experts (mental health, education, and self-harm); (3) findings from focus groups with young people; and (4) coproduction workshops with school staff. Thematic analysis using the framework method was applied. Results: Coproduction sessions with experts and the technical provider enabled us to produce a draft of the training content, a wireframe, and example high-fidelity user interface designs. Analysis of focus groups and workshops generated four key themes: (1) need for a training program; (2) acceptability, practicality, and implementation; (3) design, content, and navigation; and (4) adaptations and improvements. The findings showed that there is a clear need for a web-based training program about self-harm in schools, and the proposed program content and design were useful, practical, and acceptable. Consultations with stakeholders informed the iterative development of the prototype. Conclusions: SORTS is a web-based training program for school staff to appropriately respond to students who self-harm that is based on research evidence and developed in collaboration with stakeholders. The SORTS program will equip school staff with the skills and strategies to respond in a supportive way to students who self-harm and encourage schools to adopt a whole-school approach to self-harm. Further research is needed to complete the intervention development based on the feedback from this study and evaluate the program’s effectiveness. If found to be effective, the SORTS program could be implemented in schools and other youth organizations. %M 38833286 %R 10.2196/50024 %U https://formative.jmir.org/2024/1/e50024 %U https://doi.org/10.2196/50024 %U http://www.ncbi.nlm.nih.gov/pubmed/38833286 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e40275 %T The Use of Text Messaging as an Adjunct to Internet-Based Cognitive Behavioral Therapy for Major Depressive Disorder in Youth: Secondary Analysis %A Walters,Clarice %A Gratzer,David %A Dang,Kevin %A Laposa,Judith %A Knyahnytska,Yuliya %A Ortiz,Abigail %A Gonzalez-Torres,Christina %A Moore,Lindsay P %A Chen,Sheng %A Ma,Clement %A Daskalakis,Zafiris %A Ritvo,Paul %+ School of Kinesiology and Health Sciences, York University, 4700 Keele St, Toronto, ON, M3J1P3, Canada, 1 4165808021, paul.ritvo@gmail.com %K online intervention %K randomized controlled trial %K major depressive disorder %K text message %K online %K cognitive %K behavior therapy %K treatment %K depression %K disorder %K symptoms %K young adults %K wellness %K procedure %K anxiety %K model %D 2024 %7 31.5.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: As an established treatment for major depressive disorder (MDD), cognitive behavioral therapy (CBT) is now implemented and assessed in internet-based formats that, when combined with smartphone apps, enable secure text messaging. As an adjunct to such internet-based CBT (ICBT) approaches, text messaging has been associated with increased adherence and therapeutic alliance. Objective: This study analyzed data from the intervention arm of a randomized control trial evaluating 24-week ICBT for MDD (intervention arm) against standard-care psychiatry (waitlist control). The aim of this secondary analysis was to assess MDD symptom improvement in relation to the frequency and content of text messages sent by ICBT participants to Navigator-Coaches during randomized control trial participation. Higher text frequency in general and in 3 conceptual categories (appreciating alliance, alliance building disclosures, and agreement confirmation) was hypothesized to predict larger MDD symptom improvement. Methods: Participants were young adults (18-30 years) from the Centre for Addiction and Mental Health. The frequencies of categorized texts from 20 ICBT completers were analyzed with respect to MDD symptom improvement using linear regression models. Texts were coded by 2 independent coders and categorized using content analysis. MDD symptoms were measured using the Beck Depression Inventory-II (BDI-II). Results: Participants sent an average of 136 text messages. Analyses indicated that BDI-II improvement was negatively associated with text messaging frequency in general (β=–0.029, 95% CI –0.11 to 0.048) and in each of the 3 categories: appreciating alliance (β=–0.096, 95% CI –0.80 to 0.61), alliance building disclosures (β=–0.098, 95% CI –0.28 to 0.084), and agreement confirmation (β=–0.076, 95% CI –0.40 to 0.25). Altogether, the effect of text messaging on BDI-II improvement was uniformly negative across statistical models. More text messaging appeared associated with less MDD symptom improvement. Conclusions: The hypothesized positive associations between conceptually categorized text messages and MDD symptom improvement were not supported in this study. Instead, more text messaging appeared to indicate less treatment benefit. Future studies with larger samples are needed to discern the optimal use of text messaging in ICBT approaches using adjunctive modes of communication. Trial Registration: Clinical Trials.gov NCT03406052; https://www.clinicaltrials.gov/ct2/show/NCT03406052 %M 38820586 %R 10.2196/40275 %U https://formative.jmir.org/2024/1/e40275 %U https://doi.org/10.2196/40275 %U http://www.ncbi.nlm.nih.gov/pubmed/38820586 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54728 %T Daily Time-Use Patterns and Quality of Life in Parents: Protocol for a Pilot Quasi-Experimental, Nonrandomized Controlled Trial Using Ecological Momentary Assessment %A Altweck,Laura %A Schmidt,Silke %A Tomczyk,Samuel %+ Department Health and Prevention, Institute of Psychology, University of Greifswald, Robert-Blum-Str 13, Greifswald, 17487, Germany, 49 3834 420 ext 3813, laura.altweck@uni-greifswald.de %K time-use %K well-being %K parents %K ecological momentary assessment %K feasibility %K health-related quality of life %K ambulatory assessment %K work-family conflict %K gender roles %K mixed-methods %K sex differences %K stress %D 2024 %7 31.5.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The gender gap in time use and its impact on health and well-being are still prevalent. Women work longer hours than men when considering both paid and unpaid (eg, childcare and chores) work, and this gender disparity is particularly visible among parents. Less is known about factors that could potentially mediate or moderate this relationship (eg, work-family conflict and gender role beliefs). Ecological momentary assessment (EMA) allows for the documentation of changes in momentary internal states, such as time use, stress, or mood. It has shown particular validity to measure shorter-term activities (eg, unpaid work) and is thus useful to address gender differences. Objective: The feasibility of the daily EMA surveys in a parent sample will be examined. The associations between time use, well-being, and stress will be examined, along with potential moderating and mediating factors such as gender, gender role beliefs, and work-family conflict. Finally, the act of monitoring one’s own time use, well-being, and stress will be examined in relation to, for example, the quality of life. Methods: We conducted a quasi-experimental, nonrandomized controlled trial with 3 data collection methods, namely, online questionnaires, EMA surveys, and qualitative interviews. The intervention group (n=64) will participate in the online questionnaires and EMA surveys, and a subsample of the intervention group (n=6-17) will also be invited to participate in qualitative interviews. Over a period of 1 week, participants in the intervention group will answer daily EMA surveys (4 times per day). In contrast, the control group (n=17) will only participate in the online questionnaires at baseline and after 1 week. The following constructs were surveyed: sociodemographic background (eg, age, gender, and household composition; baseline questionnaire); mediators and moderators (eg, gender role beliefs and work-family conflict; baseline and follow-up questionnaires); well-being, quality of life, and trait mindfulness (baseline and follow-up questionnaires); momentary activity and well-being, as well as state mindfulness (EMA); and feasibility (baseline and follow-up questionnaires as well as interviews). We anticipate that participants will regard the daily EMA as feasible. Particular daily time-use patterns (eg, high paid and unpaid workload) are expected to be related to lower well-being, higher stress, and health-related quality of life. These associations are expected to be moderated and mediated by factors such as gender, gender role beliefs, work-family conflict, and social support. Participants in the intervention group are expected to show higher values of mindfulness, well-being, health-related quality of life, and lower stress. Results: Patient recruitment started in November 2023 and ended in mid April 2024. Data analysis commenced in mid April 2024. Conclusions: This study aims to provide valuable insights into the feasibility of using EMAs and the potential benefits of activity tracking in various aspects of daily life. Trial Registration: Open Science Framework 8qj3d; https://osf.io/8qj3d International Registered Report Identifier (IRRID): PRR1-10.2196/54728 %M 38820576 %R 10.2196/54728 %U https://www.researchprotocols.org/2024/1/e54728 %U https://doi.org/10.2196/54728 %U http://www.ncbi.nlm.nih.gov/pubmed/38820576 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e47515 %T Comparison of the Working Alliance in Blended Cognitive Behavioral Therapy and Treatment as Usual for Depression in Europe: Secondary Data Analysis of the E-COMPARED Randomized Controlled Trial %A Doukani,Asmae %A Quartagno,Matteo %A Sera,Francesco %A Free,Caroline %A Kakuma,Ritsuko %A Riper,Heleen %A Kleiboer,Annet %A Cerga-Pashoja,Arlinda %A van Schaik,Anneke %A Botella,Cristina %A Berger,Thomas %A Chevreul,Karine %A Matynia,Maria %A Krieger,Tobias %A Hazo,Jean-Baptiste %A Draisma,Stasja %A Titzler,Ingrid %A Topooco,Naira %A Mathiasen,Kim %A Vernmark,Kristofer %A Urech,Antoine %A Maj,Anna %A Andersson,Gerhard %A Berking,Matthias %A Baños,Rosa María %A Araya,Ricardo %+ Department of Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, United Kingdom, 44 020 7636 8636 ext 2463, asmae.doukani@lshtm.ac.uk %K blended psychotherapy %K cognitive behavioral therapy %K depression %K digital mental health interventions %K psychotherapy %K mental health %K program usability %K therapeutic alliance %K usability heuristics %K working alliance %D 2024 %7 31.5.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Increasing interest has centered on the psychotherapeutic working alliance as a means of understanding clinical change in digital mental health interventions in recent years. However, little is understood about how and to what extent a digital mental health program can have an impact on the working alliance and clinical outcomes in a blended (therapist plus digital program) cognitive behavioral therapy (bCBT) intervention for depression. Objective: This study aimed to test the difference in working alliance scores between bCBT and treatment as usual (TAU), examine the association between working alliance and depression severity scores in both arms, and test for an interaction between system usability and working alliance with regard to the association between working alliance and depression scores in bCBT at 3-month assessments. Methods: We conducted a secondary data analysis of the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment versus Treatment-as-usual) trial, which compared bCBT with TAU across 9 European countries. Data were collected in primary care and specialized services between April 2015 and December 2017. Eligible participants aged 18 years or older and diagnosed with major depressive disorder were randomized to either bCBT (n=476) or TAU (n=467). bCBT consisted of 6-20 sessions of bCBT (involving face-to-face sessions with a therapist and an internet-based program). TAU consisted of usual care for depression. The main outcomes were scores of the working alliance (Working Alliance Inventory-Short Revised–Client [WAI-SR-C]) and depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]) at 3 months after randomization. Other variables included system usability scores (System Usability Scale-Client [SUS-C]) at 3 months and baseline demographic information. Data from baseline and 3-month assessments were analyzed using linear regression models that adjusted for a set of baseline variables. Results: Of the 945 included participants, 644 (68.2%) were female, and the mean age was 38.96 years (IQR 38). bCBT was associated with higher composite WAI-SR-C scores compared to TAU (B=5.67, 95% CI 4.48-6.86). There was an inverse association between WAI-SR-C and PHQ-9 in bCBT (B=−0.12, 95% CI −0.17 to −0.06) and TAU (B=−0.06, 95% CI −0.11 to −0.02), in which as WAI-SR-C scores increased, PHQ-9 scores decreased. Finally, there was a significant interaction between SUS-C and WAI-SR-C with regard to an inverse association between higher WAI-SR-C scores and lower PHQ-9 scores in bCBT (b=−0.030, 95% CI −0.05 to −0.01; P=.005). Conclusions: To our knowledge, this is the first study to show that bCBT may enhance the client working alliance when compared to evidence-based routine care for depression that services reported offering. The working alliance in bCBT was also associated with clinical improvements that appear to be enhanced by good program usability. Our findings add further weight to the view that the addition of internet-delivered CBT to face-to-face CBT may positively augment experiences of the working alliance. Trial Registration: ClinicalTrials.gov NCT02542891, https://clinicaltrials.gov/study/NCT02542891; German Clinical Trials Register DRKS00006866, https://drks.de/search/en/trial/DRKS00006866; Netherlands Trials Register NTR4962, https://www.onderzoekmetmensen.nl/en/trial/25452; ClinicalTrials.Gov NCT02389660, https://clinicaltrials.gov/study/NCT02389660; ClinicalTrials.gov NCT02361684, https://clinicaltrials.gov/study/NCT02361684; ClinicalTrials.gov NCT02449447, https://clinicaltrials.gov/study/NCT02449447; ClinicalTrials.gov NCT02410616, https://clinicaltrials.gov/study/NCT02410616; ISRCTN Registry ISRCTN12388725, https://www.isrctn.com/ISRCTN12388725?q=ISRCTN12388725&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10; ClinicalTrials.gov NCT02796573, https://classic.clinicaltrials.gov/ct2/show/NCT02796573 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-016-1511-1 %M 38819882 %R 10.2196/47515 %U https://www.jmir.org/2024/1/e47515 %U https://doi.org/10.2196/47515 %U http://www.ncbi.nlm.nih.gov/pubmed/38819882 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 10 %N %P e52386 %T Engagement With a Relaxation and Mindfulness Mobile App Among People With Cancer: Exploratory Analysis of Use Data and Self-Reports From a Randomized Controlled Trial %A Schläpfer,Sonja %A Schneider,Fabian %A Santhanam,Prabhakaran %A Eicher,Manuela %A Kowatsch,Tobias %A Witt,Claudia M %A Barth,Jürgen %+ Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Sonneggstrasse 6, Zurich, 8091, Switzerland, 41 44 255 94 51, sonja.schlaepfer@usz.ch %K mobile health %K mHealth %K digital health %K eHealth %K smartphone %K mobile phone %K implementation %K adherence %K self-guided %K unguided %K fully automated %K conversational agent %K chatbot %K behavior change %K tailoring %K self-care %K cancer %K app development %D 2024 %7 31.5.2024 %9 Original Paper %J JMIR Cancer %G English %X Background: Mobile health (mHealth) apps offer unique opportunities to support self-care and behavior change, but poor user engagement limits their effectiveness. This is particularly true for fully automated mHealth apps without any human support. Human support in mHealth apps is associated with better engagement but at the cost of reduced scalability. Objective: This work aimed to (1) describe the theory-informed development of a fully automated relaxation and mindfulness app to reduce distress in people with cancer (CanRelax app 2.0), (2) describe engagement with the app on multiple levels within a fully automated randomized controlled trial over 10 weeks, and (3) examine whether engagement was related to user characteristics. Methods: The CanRelax app 2.0 was developed in iterative processes involving input from people with cancer and relevant experts. The app includes evidence-based relaxation exercises, personalized weekly coaching sessions with a rule-based conversational agent, 39 self-enactable behavior change techniques, a self-monitoring dashboard with gamification elements, highly tailored reminder notifications, an educational video clip, and personalized in-app letters. For the larger study, German-speaking adults diagnosed with cancer within the last 5 years were recruited via the web in Switzerland, Austria, and Germany. Engagement was analyzed in a sample of 100 study participants with multiple measures on a micro level (completed coaching sessions, relaxation exercises practiced with the app, and feedback on the app) and a macro level (relaxation exercises practiced without the app and self-efficacy toward self-set weekly relaxation goals). Results: In week 10, a total of 62% (62/100) of the participants were actively using the CanRelax app 2.0. No associations were identified between engagement and level of distress at baseline, sex assigned at birth, educational attainment, or age. At the micro level, 71.88% (3520/4897) of all relaxation exercises and 714 coaching sessions were completed in the app, and all participants who provided feedback (52/100, 52%) expressed positive app experiences. At the macro level, 28.12% (1377/4897) of relaxation exercises were completed without the app, and participants’ self-efficacy remained stable at a high level. At the same time, participants raised their weekly relaxation goals, which indicates a potential relative increase in self-efficacy. Conclusions: The CanRelax app 2.0 achieved promising engagement even though it provided no human support. Fully automated social components might have compensated for the lack of human involvement and should be investigated further. More than one-quarter (1377/4897, 28.12%) of all relaxation exercises were practiced without the app, highlighting the importance of assessing engagement on multiple levels. %M 38819907 %R 10.2196/52386 %U https://cancer.jmir.org/2024/1/e52386 %U https://doi.org/10.2196/52386 %U http://www.ncbi.nlm.nih.gov/pubmed/38819907 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e50976 %T Tracking and Profiling Repeated Users Over Time in Text-Based Counseling: Longitudinal Observational Study With Hierarchical Clustering %A Xu,Yucan %A Chan,Christian Shaunlyn %A Chan,Evangeline %A Chen,Junyou %A Cheung,Florence %A Xu,Zhongzhi %A Liu,Joyce %A Yip,Paul Siu Fai %+ Department of Social Work and Social Administration, The University of Hong Kong, Pokfulam, Hong Kong, China (Hong Kong), 852 91401568, sfpyip@hku.hk %K web-based counseling %K text-based counseling %K repeated users %K frequent users %K hierarchical clustering %K service effectiveness %K risk profiling %K psychological profiles %K psycholinguistic analysis %D 2024 %7 30.5.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Due to their accessibility and anonymity, web-based counseling services are expanding at an unprecedented rate. One of the most prominent challenges such services face is repeated users, who represent a small fraction of total users but consume significant resources by continually returning to the system and reiterating the same narrative and issues. A deeper understanding of repeated users and tailoring interventions may help improve service efficiency and effectiveness. Previous studies on repeated users were mainly on telephone counseling, and the classification of repeated users tended to be arbitrary and failed to capture the heterogeneity in this group of users. Objective: In this study, we aimed to develop a systematic method to profile repeated users and to understand what drives their use of the service. By doing so, we aimed to provide insight and practical implications that can inform the provision of service catering to different types of users and improve service effectiveness. Methods: We extracted session data from 29,400 users from a free 24/7 web-based counseling service from 2018 to 2021. To systematically investigate the heterogeneity of repeated users, hierarchical clustering was used to classify the users based on 3 indicators of service use behaviors, including the duration of their user journey, use frequency, and intensity. We then compared the psychological profile of the identified subgroups including their suicide risks and primary concerns to gain insights into the factors driving their patterns of service use. Results: Three clusters of repeated users with clear psychological profiles were detected: episodic, intermittent, and persistent-intensive users. Generally, compared with one-time users, repeated users showed higher suicide risks and more complicated backgrounds, including more severe presenting issues such as suicide or self-harm, bullying, and addictive behaviors. Higher frequency and intensity of service use were also associated with elevated suicide risk levels and a higher proportion of users citing mental disorders as their primary concerns. Conclusions: This study presents a systematic method of identifying and classifying repeated users in web-based counseling services. The proposed bottom-up clustering method identified 3 subgroups of repeated users with distinct service behaviors and psychological profiles. The findings can facilitate frontline personnel in delivering more efficient interventions and the proposed method can also be meaningful to a wider range of services in improving service provision, resource allocation, and service effectiveness. %M 38815258 %R 10.2196/50976 %U https://www.jmir.org/2024/1/e50976 %U https://doi.org/10.2196/50976 %U http://www.ncbi.nlm.nih.gov/pubmed/38815258 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e57849 %T Designing Child Nutrition Interventions to Engage Fathers: Qualitative Analysis of Interviews and Co-Design Workshops %A So,Jeffrey Tsz Hei %A Nambiar,Smita %A Byrne,Rebecca %A Gallegos,Danielle %A Baxter,Kimberley A %+ Centre for Childhood Nutrition Research, Faculty of Health, Queensland University of Technology, 62 Graham Street, South Brisbane, Brisbane, 4101, Australia, 61 73069 7308, jeffrey.so@hdr.qut.edu.au %K co-design %K fathers %K child nutrition %K child feeding %K intervention design %K digital delivery %K parenting %K participatory %K videoconference %K communication technology %D 2024 %7 30.5.2024 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Fathers play a pivotal role in parenting and child feeding, but they remain underrepresented in intervention studies, especially those focused on disadvantaged populations. A better understanding of fathers’ experiences and needs regarding support access and child nutrition information in the context of disadvantage can inform future interventions engaging fathers. Objective: This study aims to explore fathers’ experiences; perceived enablers; and barriers to accessing support and information related to parenting, child feeding, and nutrition and to co-design principles for tailoring child nutrition interventions to engage fathers. Methods: Australian fathers of children aged 6 months to 5 years with lived experience of disadvantage participated in semistructured interviews and co-design workshops, primarily conducted via videoconference. Creative analogies were used to guide the ideation process in the workshops. Results: A total of 25 interviews and 3 workshops (n=10 participants) were conducted, with data analyzed using reflexive thematic analysis and the Capability, Opportunity, and Motivation–Behavior model. The interview data illuminated factors influencing fathers’ initiation in seeking support for parenting, child feeding, and nutrition, including their experiences. It highlighted fathers’ diverse information needs and the importance of an inclusive environment and encouragement. Enablers and barriers in accessing support related to parenting and child nutrition were identified at the individual (eg, personal goals and resource constraints), interpersonal (family support and false beliefs about men’s caregiving role), organizational (inadequate fathering support), and systemic levels (father-inclusive practice and policy). Digital data collection methods enabled Australia-wide participation, overcoming work and capacity barriers. Videoconferencing technology was effectively used to engage fathers creatively. Key principles for engaging fathers were co-designed from the workshop data. Interventions and resources need to be father specific, child centered, and culturally appropriate; promote empowerment and collaboration; and provide actionable and accessible strategies on the what and how of child feeding. Fathers preferred multiformat implementation, which harnesses technology-based design (eg, websites and mobile apps) and gamification. It should be tailored to the child’s age and targeted at fathers using comprehensive promotion strategies. Conclusions: Fathers faced barriers to accessing support and information related to parenting and feeding that may not adequately address their needs. Future interventions could integrate the co-designed principles to engage fathers effectively. These findings have implications for health service delivery and policy development, promoting father-inclusive practice. %M 38815260 %R 10.2196/57849 %U https://pediatrics.jmir.org/2024/1/e57849 %U https://doi.org/10.2196/57849 %U http://www.ncbi.nlm.nih.gov/pubmed/38815260 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e56184 %T Digital Peer-Supported App Intervention to Promote Physical Activity Among Community-Dwelling Older Adults: Nonrandomized Controlled Trial %A Tabira,Kento %A Oguma,Yuko %A Yoshihara,Shota %A Shibuya,Megumi %A Nakamura,Manabu %A Doihara,Natsue %A Hirata,Akihiro %A Manabe,Tomoki %+ Sports Medicine Research Center, Keio University, 4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa, 223-0061, Japan, 81 45 566 1090, yoguma@keio.jp %K physical activity %K physical function %K gerontology %K geriatric %K geriatrics %K older adult %K older adults %K elder %K elderly %K older person %K older people %K ageing %K aging %K aged %K digital peer support app %K mHealth %K mobile health %K app %K apps %K application %K applications %K eHealth %K peer support %K exercise %K mobile phone %D 2024 %7 30.5.2024 %9 Original Paper %J JMIR Aging %G English %X Background: The use of mobile apps has promoted physical activity levels. Recently, with an increasing number of older adults accessing the internet, app-based interventions may be feasible in older populations. Peer support–based interventions have become a common method for promoting health-related behavior change. To our knowledge, the feasibility of using digital peer support apps (DPSAs) to increase physical activity among older adults and its impact on physical activity and physical function have not been investigated. Objective: This study aims to assess the feasibility of using DPSAs in older adults and to assess changes in physical activity and physical function in DPSA users. Methods: We conducted a nonrandomized controlled trial of older adults aged ≥65 years. We recruited participants for 2 distinct 12-week programs designed to increase physical activity. Participants could choose between an intervention group (app program and exercise instruction) or a control group (exercise instruction only). DPSA creates a group chat for up to 5 people with a common goal, and participants anonymously post to each other in the group. Once a day, participants posted a set of their step counts, photos, and comments on a group chat box. The intervention group used the DPSA after receiving 2 face-to-face lectures on its use. The participants were characterized using questionnaires, accelerometers, and physical function assessments. The feasibility of the DPSA was assessed using retention and adherence rates. Physical activity was assessed using accelerometers to measure the daily step count, light intensity physical activity, moderate to vigorous intensity physical activity (MVPA), and sedentary behavior. Physical function was assessed using grip strength and the 30-second chair-stand test. Results: The participants in the intervention group were more frequent users of apps, were more familiar with information and communication technology, and had a higher baseline physical activity level. The retention and adherence rates for the DPSA intervention were 88% (36/41) and 87.7%, respectively, indicating good feasibility. Participants in the intervention group increased their step count by at least 1000 steps and their MVPA by at least 10 minutes using the DPSA. There was a significant difference in the interaction between groups and intervention time points in the daily step count and MVPA (step count, P=.04; duration of MVPA, P=.02). The DPSA increased physical activity, especially in older adults with low baseline physical activity levels. Conclusions: The feasibility of DPSA was found to be good, with the intervention group showing increases in daily steps and MVPA. The effects of DPSA on step count, physical activity, and physical function in older adults with low baseline physical activity should be investigated using randomized controlled trials. %M 38814686 %R 10.2196/56184 %U https://aging.jmir.org/2024/1/e56184 %U https://doi.org/10.2196/56184 %U http://www.ncbi.nlm.nih.gov/pubmed/38814686 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e56561 %T MyPEEPS Mobile App for HIV Prevention Among Transmasculine Youth: Adaptation Through Community-Based Feedback and Usability Evaluation %A Adedoja,Dorcas %A Kuhns,Lisa M %A Radix,Asa %A Garofalo,Robert %A Brin,Maeve %A Schnall,Rebecca %+ Columbia University School of Nursing, 560 W. 168th Street, New York City, NY, 10032, United States, 1 2123426886, rb897@columbia.edu %K HIV %K mobile app %K transgender men %K transmasculine %D 2024 %7 30.5.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Transgender men and transmasculine youth are at high risk for acquiring HIV. Growing research on transgender men demonstrates increased HIV risk and burden compared with the general US population. Despite biomedical advancements in HIV prevention, there remains a dearth of evidence-based, sexual health HIV prevention interventions for young transgender men. MyPEEPS (Male Youth Pursuing Empowerment, Education, and Prevention around Sexuality) Mobile is a web-based app that builds on extensive formative community–informed work to develop an evidence-based HIV prevention intervention. Our study team developed and tested the MyPEEPS Mobile intervention for 13- to 18-year-old cisgender young men in a national randomized controlled trial, which demonstrated efficacy to reduce sexual risk in the short term—at 3-month follow-up. Trans men and transmasculine youth resonated with basic HIV educational information and sexual scenarios of the original MyPEEPS app for cisgender men, but recognized the app's lack of transmasculine specificity. Objective: The purpose of this study is to detail the user-centered design methods to adapt, improve the user interface, and enhance the usability of the MyPEEPS Mobile app for young transgender men and transmasculine youth. Methods: The MyPEEPS Mobile app for young transgender men was adapted through a user-centered design approach, which included an iterative review of the adapted prototype by expert advisors and a youth advisory board. The app was then evaluated through a rigorous usability evaluation. Results: MyPEEPS Mobile is among the first mobile health interventions developed to meet the specific needs of young transgender men and transmasculine youth to reduce HIV risk behaviors. While many of the activities in the original MyPEEPS Mobile were rigorously developed and tested, there was a need to adapt our intervention to meet the specific needs and risk factors among young transgender men and transmasculine youth. The findings from this study describe the adaptation of these activities through feedback from a youth advisory board and expert advisors. Following adaptation of the content, the app underwent a rigorous usability assessment through an evaluation with experts in human-computer interaction (n=5) and targeted end users (n=20). Conclusions: Usability and adaptation findings demonstrate that the MyPEEPS Mobile app is highly usable and perceived as potentially useful for targeting HIV risk behaviors in young transgender men and transmasculine youth. %M 38814701 %R 10.2196/56561 %U https://formative.jmir.org/2024/1/e56561 %U https://doi.org/10.2196/56561 %U http://www.ncbi.nlm.nih.gov/pubmed/38814701 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e50025 %T Effectiveness of a Mental Health Chatbot for People With Chronic Diseases: Randomized Controlled Trial %A MacNeill,A Luke %A Doucet,Shelley %A Luke,Alison %+ Centre for Research in Integrated Care, University of New Brunswick, 355 Campus Ring Road, Saint John, NB, E2L 4L5, Canada, 1 506 648 5777, luke.macneill@unb.ca %K chatbot %K chronic disease %K arthritis %K diabetes %K mental health %K depression %K anxiety %K stress %K effectiveness %K application %D 2024 %7 30.5.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: People with chronic diseases tend to experience more mental health issues than their peers without these health conditions. Mental health chatbots offer a potential source of mental health support for people with chronic diseases. Objective: The aim of this study was to determine whether a mental health chatbot can improve mental health in people with chronic diseases. We focused on 2 chronic diseases in particular: arthritis and diabetes. Methods: Individuals with arthritis or diabetes were recruited using various web-based methods. Participants were randomly assigned to 1 of 2 groups. Those in the treatment group used a mental health chatbot app (Wysa [Wysa Inc]) over a period of 4 weeks. Those in the control group received no intervention. Participants completed measures of depression (Patient Health Questionnaire–9), anxiety (Generalized Anxiety Disorder Scale–7), and stress (Perceived Stress Scale–10) at baseline, with follow-up testing 2 and 4 weeks later. Participants in the treatment group completed feedback questions on their experiences with the app at the final assessment point. Results: A total of 68 participants (n=47, 69% women; mean age 42.87, SD 11.27 years) were included in the analysis. Participants were divided evenly between the treatment and control groups. Those in the treatment group reported decreases in depression (P<.001) and anxiety (P<.001) severity over the study period. No such changes were found among participants in the control group. No changes in stress were reported by participants in either group. Participants with arthritis reported higher levels of depression (P=.004) and anxiety (P=.004) severity than participants with diabetes over the course of the study, as well as higher levels of stress (P=.01); otherwise, patterns of results were similar across these health conditions. In response to the feedback questions, participants in the treatment group said that they liked many of the functions and features of the app, the general design of the app, and the user experience. They also disliked some aspects of the app, with most of these reports focusing on the chatbot’s conversational abilities. Conclusions: The results of this study suggest that mental health chatbots can be an effective source of mental health support for people with chronic diseases such as arthritis and diabetes. Although cost-effective and accessible, these programs have limitations and may not be well suited for all individuals. Trial Registration: ClinicalTrials.gov NCT04620668; https://www.clinicaltrials.gov/study/NCT04620668 %M 38814681 %R 10.2196/50025 %U https://formative.jmir.org/2024/1/e50025 %U https://doi.org/10.2196/50025 %U http://www.ncbi.nlm.nih.gov/pubmed/38814681 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e51916 %T The Effect of an AI-Based, Autonomous, Digital Health Intervention Using Precise Lifestyle Guidance on Blood Pressure in Adults With Hypertension: Single-Arm Nonrandomized Trial %A Leitner,Jared %A Chiang,Po-Han %A Agnihotri,Parag %A Dey,Sujit %+ Electrical and Computer Engineering Department, University of California, San Diego, 9500 Gilman Dr, La Jolla, CA, 92093, United States, 1 8587220467, jjleitne@ucsd.edu %K blood pressure %K hypertension %K digital health %K lifestyle change %K lifestyle medicine %K wearables %K remote patient monitoring %K artificial intelligence %K AI %K mobile phone %D 2024 %7 28.5.2024 %9 Original Paper %J JMIR Cardio %G English %X Background: Home blood pressure (BP) monitoring with lifestyle coaching is effective in managing hypertension and reducing cardiovascular risk. However, traditional manual lifestyle coaching models significantly limit availability due to high operating costs and personnel requirements. Furthermore, the lack of patient lifestyle monitoring and clinician time constraints can prevent personalized coaching on lifestyle modifications. Objective: This study assesses the effectiveness of a fully digital, autonomous, and artificial intelligence (AI)–based lifestyle coaching program on achieving BP control among adults with hypertension. Methods: Participants were enrolled in a single-arm nonrandomized trial in which they received a BP monitor and wearable activity tracker. Data were collected from these devices and a questionnaire mobile app, which were used to train personalized machine learning models that enabled precision lifestyle coaching delivered to participants via SMS text messaging and a mobile app. The primary outcomes included (1) the changes in systolic and diastolic BP from baseline to 12 and 24 weeks and (2) the percentage change of participants in the controlled, stage-1, and stage-2 hypertension categories from baseline to 12 and 24 weeks. Secondary outcomes included (1) the participant engagement rate as measured by data collection consistency and (2) the number of manual clinician outreaches. Results: In total, 141 participants were monitored over 24 weeks. At 12 weeks, systolic and diastolic BP decreased by 5.6 mm Hg (95% CI −7.1 to −4.2; P<.001) and 3.8 mm Hg (95% CI −4.7 to −2.8; P<.001), respectively. Particularly, for participants starting with stage-2 hypertension, systolic and diastolic BP decreased by 9.6 mm Hg (95% CI −12.2 to −6.9; P<.001) and 5.7 mm Hg (95% CI −7.6 to −3.9; P<.001), respectively. At 24 weeks, systolic and diastolic BP decreased by 8.1 mm Hg (95% CI −10.1 to −6.1; P<.001) and 5.1 mm Hg (95% CI −6.2 to −3.9; P<.001), respectively. For participants starting with stage-2 hypertension, systolic and diastolic BP decreased by 14.2 mm Hg (95% CI −17.7 to −10.7; P<.001) and 8.1 mm Hg (95% CI −10.4 to −5.7; P<.001), respectively, at 24 weeks. The percentage of participants with controlled BP increased by 17.2% (22/128; P<.001) and 26.5% (27/102; P<.001) from baseline to 12 and 24 weeks, respectively. The percentage of participants with stage-2 hypertension decreased by 25% (32/128; P<.001) and 26.5% (27/102; P<.001) from baseline to 12 and 24 weeks, respectively. The average weekly participant engagement rate was 92% (SD 3.9%), and only 5.9% (6/102) of the participants required manual outreach over 24 weeks. Conclusions: The study demonstrates the potential of fully digital, autonomous, and AI-based lifestyle coaching to achieve meaningful BP improvements and high engagement for patients with hypertension while substantially reducing clinician workloads. Trial Registration: ClinicalTrials.gov NCT06337734; https://clinicaltrials.gov/study/NCT06337734 %M 38805253 %R 10.2196/51916 %U https://cardio.jmir.org/2024/1/e51916 %U https://doi.org/10.2196/51916 %U http://www.ncbi.nlm.nih.gov/pubmed/38805253 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e50454 %T Effects of a Chatbot-Based Intervention on Stress and Health-Related Parameters in a Stressed Sample: Randomized Controlled Trial %A Schillings,Christine %A Meißner,Echo %A Erb,Benjamin %A Bendig,Eileen %A Schultchen,Dana %A Pollatos,Olga %+ Department of Clinical and Health Psychology, Institute of Psychology and Education, Ulm University, Albert-Einstein-Allee 43, Ulm, 89081, Germany, 49 731 50 31738, christine.schillings@uni-ulm.de %K chatbot %K intervention %K stress %K interoception %K interoceptive sensibility %K mindfulness %K emotion regulation %K RCT %K randomized controlled trial %D 2024 %7 28.5.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Stress levels and the prevalence of mental disorders in the general population have been rising in recent years. Chatbot-based interventions represent novel and promising digital approaches to improve health-related parameters. However, there is a lack of research on chatbot-based interventions in the area of mental health. Objective: The aim of this study was to investigate the effects of a 3-week chatbot-based intervention guided by the chatbot ELME, specifically with respect to the ability to reduce stress and improve various health-related parameters in a stressed sample. Methods: In this multicenter two-armed randomized controlled trial, 118 individuals with medium to high stress levels were randomized to the intervention group (n=59) or the treatment-as-usual control group (n=59). The ELME chatbot guided participants of the intervention group through 3 weeks of training based on the topics stress, mindfulness, and interoception, with practical and psychoeducative elements delivered in two daily interactive intervention sessions via a smartphone (approximately 10-20 minutes each). The primary outcome (perceived stress) and secondary outcomes (mindfulness; interoception or interoceptive sensibility; subjective well-being; and emotion regulation, including the subfacets reappraisal and suppression) were assessed preintervention (T1), post intervention (T2; after 3 weeks), and at follow-up (T3; after 6 weeks). During both conditions, participants also underwent ecological momentary assessments of stress and interoceptive sensibility. Results: There were no significant changes in perceived stress (β03=–.018, SE=.329; P=.96) and momentary stress. Mindfulness and the subfacet reappraisal significantly increased in the intervention group over time, whereas there was no change in the subfacet suppression. Well-being and momentary interoceptive sensibility increased in both groups over time. Conclusions: To gain insight into how the intervention can be improved to achieve its full potential for stress reduction, besides a longer intervention duration, specific sample subgroups should be considered. The chatbot-based intervention seems to have the potential to improve mindfulness and emotion regulation in a stressed sample. Future chatbot-based studies and interventions in health care should be designed based on the latest findings on the efficacy of rule-based and artificial intelligence–based chatbots. Trial Registration: German Clinical Trials Register DRKS00027560; https://drks.de/search/en/trial/DRKS00027560 International Registered Report Identifier (IRRID): RR2-doi.org/10.3389/fdgth.2023.1046202 %M 38805259 %R 10.2196/50454 %U https://mental.jmir.org/2024/1/e50454 %U https://doi.org/10.2196/50454 %U http://www.ncbi.nlm.nih.gov/pubmed/38805259 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53872 %T Assessing the Content and Effect of Web-Based Decision Aids for Postmastectomy Breast Reconstruction: Systematic Review and Meta-Analysis of Randomized Controlled Trials %A Yu,Lin %A Gong,Jianmei %A Sun,Xiaoting %A Zang,Min %A Liu,Lei %A Yu,Shengmiao %+ School of Nursing, Liaoning University of Chinese Traditional Medicine, No.79 Chongshan Dong Road, Shenyang, 110000, China, 86 17824909908, liulei0428@sina.com %K decision aids %K internet %K postmastectomy breast reconstruction %K decision conflicts %K mobile phone %D 2024 %7 27.5.2024 %9 Review %J J Med Internet Res %G English %X Background: Web-based decision aids have been shown to have a positive effect when used to improve the quality of decision-making for women facing postmastectomy breast reconstruction (PMBR). However, the existing findings regarding these interventions are still incongruent, and the overall effect is unclear. Objective: We aimed to assess the content of web-based decision aids and its impact on decision-related outcomes (ie, decision conflict, decision regret, informed choice, and knowledge), psychological-related outcomes (ie, satisfaction and anxiety), and surgical decision-making in women facing PMBR. Methods: This systematic review and meta-analysis followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. A total of 6 databases, PubMed, Embase, Cochrane Library, CINAHL, PsycINFO, and Web of Science Core Collection, were searched starting at the time of establishment of the databases to May 2023, and an updated search was conducted on April 1, 2024. MeSH (Medical Subject Headings) terms and text words were used. The Cochrane Risk of Bias Tool for randomized controlled trials was used to assess the risk of bias. The certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation approach. Results: In total, 7 studies included 579 women and were published between 2008 and 2023, and the sample size in each study ranged from 26 to 222. The results showed that web-based decision aids used audio and video to present the pros and cons of PMBR versus no PMBR, implants versus flaps, and immediate versus delayed PMBR and the appearance and feel of the PMBR results and the expected recovery time with photographs of actual patients. Web-based decision aids help improve PMBR knowledge, decisional conflict (mean difference [MD]=–5.43, 95% CI –8.87 to –1.99; P=.002), and satisfaction (standardized MD=0.48, 95% CI 0.00 to 0.95; P=.05) but have no effect on informed choice (MD=–2.80, 95% CI –8.54 to 2.94; P=.34), decision regret (MD=–1.55, 95% CI –6.00 to 2.90 P=.49), or anxiety (standardized MD=0.04, 95% CI –0.50 to 0.58; P=.88). The overall Grading of Recommendations, Assessment, Development, and Evaluation quality of the evidence was low. Conclusions: The findings suggest that the web-based decision aids provide a modern, low-cost, and high dissemination rate effective method to promote the improved quality of decision-making in women undergoing PMBR. Trial Registration: PROSPERO CRD42023450496; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=450496 %M 38801766 %R 10.2196/53872 %U https://www.jmir.org/2024/1/e53872 %U https://doi.org/10.2196/53872 %U http://www.ncbi.nlm.nih.gov/pubmed/38801766 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e54375 %T Digital Behavior Change Intervention Designs for Habit Formation: Systematic Review %A Zhu,Yujie %A Long,Yonghao %A Wang,Hailiang %A Lee,Kun Pyo %A Zhang,Lie %A Wang,Stephen Jia %+ School of Design, The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Hong Kong, China (Hong Kong), 852 2766 5478, stephen.j.wang@polyu.edu.hk %K habit formation %K digital health %K digital behavior change interventions design %K behavior change techniques %K physical activity %K mobile phone %D 2024 %7 24.5.2024 %9 Review %J J Med Internet Res %G English %X Background: With the development of emerging technologies, digital behavior change interventions (DBCIs) help to maintain regular physical activity in daily life. Objective: To comprehensively understand the design implementations of habit formation techniques in current DBCIs, a systematic review was conducted to investigate the implementations of behavior change techniques, types of habit formation techniques, and design strategies in current DBCIs. Methods: The process of this review followed the PRISMA (Preferred Reporting Item for Systematic Reviews and Meta-Analyses) guidelines. A total of 4 databases were systematically searched from 2012 to 2022, which included Web of Science, Scopus, ACM Digital Library, and PubMed. The inclusion criteria encompassed studies that used digital tools for physical activity, examined behavior change intervention techniques, and were written in English. Results: A total of 41 identified research articles were included in this review. The results show that the most applied behavior change techniques were the self-monitoring of behavior, goal setting, and prompts and cues. Moreover, habit formation techniques were identified and developed based on intentions, cues, and positive reinforcement. Commonly used methods included automatic monitoring, descriptive feedback, general guidelines, self-set goals, time-based cues, and virtual rewards. Conclusions: A total of 32 commonly design strategies of habit formation techniques were summarized and mapped to the proposed conceptual framework, which was categorized into target-mediated (generalization and personalization) and technology-mediated interactions (explicitness and implicitness). Most of the existing studies use the explicit interaction, aligning with the personalized habit formation techniques in the design strategies of DBCIs. However, implicit interaction design strategies are lacking in the reviewed studies. The proposed conceptual framework and potential solutions can serve as guidelines for designing strategies aimed at habit formation within DBCIs. %M 38787601 %R 10.2196/54375 %U https://www.jmir.org/2024/1/e54375 %U https://doi.org/10.2196/54375 %U http://www.ncbi.nlm.nih.gov/pubmed/38787601 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e54412 %T Examining the Effects of a Brief, Fully Self-Guided Mindfulness Ecological Momentary Intervention on Empathy and Theory-of-Mind for Generalized Anxiety Disorder: Randomized Controlled Trial %A Zainal,Nur Hani %A Newman,Michelle G %+ Department of Psychology, National University of Singapore, 9 Arts Link, Singapore, 117572, Singapore, 65 917 767 7088, hanizainal@nus.edu.sg %K empathy %K theory-of-mind %K mindfulness %K ecological momentary intervention %K generalized anxiety disorder %K randomized controlled trial %K mobile phone %D 2024 %7 24.5.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: The utility of brief mindfulness ecological momentary interventions (EMIs) to improve empathy and theory-of-mind has been underinvestigated, particularly in generalized anxiety disorder (GAD). Objective: In this randomized controlled trial, we aimed to examine the efficacy of a 14-day, fully self-guided, mindfulness EMI on the empathy and theory-of-mind domains for GAD. Methods: Adults (aged ≥18 y) diagnosed with GAD were randomized to a mindfulness EMI (68/110, 61.8%) or self-monitoring app (42/110, 38.2%) arm. They completed the Interpersonal Reactivity Index self-report empathy measure and theory-of-mind test (Bell-Lysaker Emotion Recognition Task) at prerandomization, postintervention, and 1-month follow-up (1MFU) time points. Hierarchical linear modeling was conducted with the intent-to-treat principle to determine prerandomization to postintervention (pre-post intervention) and prerandomization to 1MFU (pre-1MFU) changes, comparing the mindfulness EMI to self-monitoring. Results: Observed effects were generally stronger from pre-1MFU than from pre-post intervention time points. From pre-post intervention time points, the mindfulness EMI was more efficacious than the self-monitoring app on fantasy (the ability to imagine being in others’ shoes; between-intervention effect size: Cohen d=0.26, P=.007; within-intervention effect size: Cohen d=0.22, P=.02 for the mindfulness EMI and Cohen d=−0.16, P=.10 for the self-monitoring app). From pre-1MFU time points, the mindfulness EMI, but not the self-monitoring app, improved theory-of-mind (a window into others’ thoughts and intentions through abstract, propositional knowledge about their mental states, encompassing the ability to decipher social cues) and the fantasy, personal distress (stress when witnessing others’ negative experiences), and perspective-taking (understanding others’ perspective) empathy domains. The effect sizes were small to moderate (Cohen d=0.15-0.36; P<.001 to P=.01) for significant between-intervention effects from pre-1MFU time points. Furthermore, the within-intervention effect sizes for these significant outcomes were stronger for the mindfulness EMI (Cohen d=0.30-0.43; P<.001 to P=.03) than the self-monitoring app (Cohen d=−0.12 to 0.21; P=.001 to P>.99) from pre-1MFU time points. No between-intervention and within-intervention effects on empathic concern (feeling affection, compassion, and care when observing others in distress, primarily attending to their emotional well-being) were observed from pre-post intervention and pre-1MFU time points. Conclusions: The brief mindfulness EMI improved specific domains of empathy (eg, fantasy, personal distress, and perspective-taking) and theory-of-mind with small to moderate effect sizes in persons with GAD. Higher-intensity, self-guided or coach-facilitated, multicomponent mindfulness EMIs targeting the optimization of social relationships are likely necessary to improve the empathic concern domain in this population. Trial Registration: ClinicalTrials.gov NCT04846777; https://clinicaltrials.gov/study/NCT04846777 %M 38787613 %R 10.2196/54412 %U https://mental.jmir.org/2024/1/e54412 %U https://doi.org/10.2196/54412 %U http://www.ncbi.nlm.nih.gov/pubmed/38787613 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e50446 %T Evaluating a New Digital App–Based Program for Heart Health: Feasibility and Acceptability Pilot Study %A Lockwood,Kimberly G %A Kulkarni,Priya R %A Paruthi,Jason %A Buch,Lauren S %A Chaffard,Mathieu %A Schitter,Eva C %A Branch,OraLee H %A Graham,Sarah A %+ Lark Health, 809 Cuesta Dr, Suite B #1033, Mountain View, CA, 94040, United States, 1 5033801340, kimberly.lockwood@lark.com %K digital health %K cardiovascular disease %K artificial intelligence %K AI %K acceptability and feasibility %K pilot study %K lifestyle coaching %K mobile phone %D 2024 %7 24.5.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Cardiovascular disease (CVD) is the leading cause of death in the United States, affecting a significant proportion of adults. Digital health lifestyle change programs have emerged as a promising method of CVD prevention, offering benefits such as on-demand support, lower cost, and increased scalability. Prior research has shown the effectiveness of digital health interventions in reducing negative CVD outcomes. This pilot study focuses on the Lark Heart Health program, a fully digital artificial intelligence (AI)–powered smartphone app, providing synchronous CVD risk counseling, educational content, and personalized coaching. Objective: This pilot study evaluated the feasibility and acceptability of a fully digital AI-powered lifestyle change program called Lark Heart Health. Primary analyses assessed (1) participant satisfaction, (2) engagement with the program, and (3) the submission of health screeners. Secondary analyses were conducted to evaluate weight loss outcomes, given that a major focus of the Heart Health program is weight management. Methods: This study enrolled 509 participants in the 90-day real-world single-arm pilot study of the Heart Health app. Participants engaged with the app by participating in coaching conversations, logging meals, tracking weight, and completing educational lessons. The study outcomes included participant satisfaction, app engagement, the completion of screeners, and weight loss. Results: On average, Heart Health study participants were aged 60.9 (SD 10.3; range 40-75) years, with average BMI indicating class I obesity. Of the 509 participants, 489 (96.1%) stayed enrolled until the end of the study (dropout rate: 3.9%). Study retention, based on providing a weight measurement during month 3, was 80% (407/509; 95% CI 76.2%-83.4%). Participant satisfaction scores indicated high satisfaction with the overall app experience, with an average score of ≥4 out of 5 for all satisfaction indicators. Participants also showed high engagement with the app, with 83.4% (408/489; 95% CI 80.1%-86.7%) of the sample engaging in ≥5 coaching conversations in month 3. The results indicated that participants were successfully able to submit health screeners within the app, with 90% (440/489; 95% CI 87%-92.5%) submitting all 3 screeners measured in the study. Finally, secondary analyses showed that participants lost weight during the program, with analyses showing an average weight nadir of 3.8% (SD 2.9%; 95% CI 3.5%-4.1%). Conclusions: The study results indicate that participants in this study were satisfied with their experience using the Heart Health app, highly engaged with the app features, and willing and able to complete health screening surveys in the app. These acceptability and feasibility results provide a key first step in the process of evidence generation for a new AI-powered digital program for heart health. Future work can expand these results to test outcomes with a commercial version of the Heart Health app in a diverse real-world sample. %M 38787598 %R 10.2196/50446 %U https://formative.jmir.org/2024/1/e50446 %U https://doi.org/10.2196/50446 %U http://www.ncbi.nlm.nih.gov/pubmed/38787598 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e46108 %T Mobile Health Apps, Family Caregivers, and Care Planning: Scoping Review %A Kelley,Marjorie M %A Powell,Tia %A Camara,Djibril %A Shah,Neha %A Norton,Jenna M %A Deitelzweig,Chelsea %A Vaidy,Nivedha %A Hsiao,Chun-Ju %A Wang,Jing %A Bierman,Arlene S %+ Agency for Health Care Research and Quality, 5600 Fishers Lane, Rockville, MD, 20857, United States, 1 (301) 427 1104, arlene.bierman@ahrq.hhs.gov %K caregivers %K carers %K informal caregivers %K family caregivers %K mHealth applications %K telemedicine %K mobile health %K mHealth %K eHealth %K digital health %K apps %K chronic condition %K caregiver %K application %K support %K clinicians %K development %K electronic health record %K implementation %K mobile phone %D 2024 %7 23.5.2024 %9 Review %J J Med Internet Res %G English %X Background: People living with multiple chronic conditions (MCCs) face substantial challenges in planning and coordinating increasingly complex care. Family caregivers provide important assistance for people with MCCs but lack sufficient support. Caregiver apps have the potential to help by enhancing care coordination and planning among the health care team, including patients, caregivers, and clinicians. Objective: We aim to conduct a scoping review to assess the evidence on the development and use of caregiver apps that support care planning and coordination, as well as to identify key factors (ie, needs, barriers, and facilitators) related to their use and desired caregiver app functionalities. Methods: Papers intersecting 2 major domains, mobile health (mHealth) apps and caregivers, that were in English and published from 2015 to 2021 were included in the initial search from 6 databases and gray literature and ancestry searches. As per JBI (Joanna Briggs Institute) Scoping Review guidelines and PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews), 2 authors independently screened full texts with disagreements resolved by a third author. Working in pairs, the authors extracted data using a pilot-tested JBI extraction table and compared results for consensus. Results: We identified 34 papers representing 25 individual studies, including 18 (53%) pilot and feasibility studies, 13 (38%) qualitative studies, and 2 experimental or quasi-experimental studies. None of the identified studies assessed an intervention of a caregiver app for care planning and coordination for people with MCCs. We identified important caregiver needs in terms of information, support, and care coordination related to both caregiving and self-care. We compiled desired functionalities and features enabling apps to meet the care planning and care coordination needs of caregivers, in particular, the integration of caregiver roles into the electronic health record. Conclusions: Caregiver needs identified through this study can inform developers and researchers in the design and implementation of mHealth apps that integrate with the electronic health record to link caregivers, patients, and clinicians to support coordinated care for people with MCCs. In addition, this study highlights the need for more rigorous research on the use of mHealth apps to support caregivers in care planning and coordination. %M 38781588 %R 10.2196/46108 %U https://www.jmir.org/2024/1/e46108 %U https://doi.org/10.2196/46108 %U http://www.ncbi.nlm.nih.gov/pubmed/38781588 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e54821 %T The Power of Rapid Reviews for Bridging the Knowledge-to-Action Gap in Evidence-Based Virtual Health Care %A MacPherson,Megan %A Rourke,Sarah %+ Fraser Health, 400-13450 102nd Avenue, Surrey, BC, V3T 0H1, Canada, 1 6045616605, meganmargaretmacpherson@gmail.com %K virtual health care %K rapid reviews %K evidence synthesis %K evidence-informed decision-making %K knowledge translation %D 2024 %7 22.5.2024 %9 Viewpoint %J J Med Internet Res %G English %X Despite the surge in popularity of virtual health care services as a means of delivering health care through technology, the integration of research evidence into practice remains a challenge. Rapid reviews, a type of time-efficient evidence synthesis, offer a potential solution to bridge the gap between knowledge and action. This paper aims to highlight the experiences of the Fraser Health Authority’s Virtual Health team in conducting rapid reviews. This paper discusses the experiences of the Virtual Health team in conducting 15 rapid reviews over the course of 1.5 years and the benefit of involving diverse stakeholders including researchers, project and clinical leads, and students for the creation of user-friendly knowledge products to summarize results. The Virtual Health team found rapid reviews to be a valuable tool for evidence-informed decision-making in virtual health care. Involving stakeholders and focusing on implementation considerations are crucial for maximizing the impact of rapid reviews. Health care decision makers are encouraged to consider implementing rapid review processes to improve the translation of research evidence into practice, ultimately enhancing patient outcomes and promoting a culture of evidence-informed care. %M 38776542 %R 10.2196/54821 %U https://www.jmir.org/2024/1/e54821 %U https://doi.org/10.2196/54821 %U http://www.ncbi.nlm.nih.gov/pubmed/38776542 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e54586 %T A Web-Based Intervention to Support the Mental Well-Being of Sexual and Gender Minority Young People: Mixed Methods Co-Design of Oneself %A Brown,Katherine %A Lucassen,Mathijs F G %A Núñez-García,Alicia %A Rimes,Katharine A %A Wallace,Louise M %A Samra,Rajvinder %+ Centre for Research in Psychology and Sports Science, School of Life and Medical Sciences, University of Hertfordshire, College Lane, Hatfield, AL109AB, United Kingdom, 44 1707 284 615, k.brown25@herts.ac.uk %K sexual minority %K gender minority %K lesbian, gay, bisexual, transgender, queer %K LGBTQ+ %K mental well-being %K support %K intervention %K resilience %K digital %K co-design %K sexual and gender minority youth %K SGMY %K mobile phone %D 2024 %7 21.5.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Sexual and gender minority youth are at greater risk of compromised mental health than their heterosexual and cisgender peers. This is considered to be due to an increased burden of stigma, discrimination, or bullying resulting in a heightened experience of daily stress. Given the increasing digital accessibility and a strong preference for web-based support among sexual and gender minority youth, digital interventions are a key means to provide support to maintain their well-being. Objective: This paper aims to explicate the co-design processes and underpinning logic of Oneself, a bespoke web-based intervention for sexual and gender minority youth. Methods: This study followed a 6-stage process set out by Hagen et al (identify, define, position, concept, create, and use), incorporating a systematic scoping review of existing evidence, focus groups with 4 stakeholder groups (ie, sexual and gender minority youth, professionals who directly support them, parents, and UK public health service commissioners), a series of co-design workshops and web-based consultations with sexual and gender minority youth, the appointment of a digital development company, and young adult sexual and gender minority contributors to create content grounded in authentic experiences. Results: Oneself features a welcome and home page, including a free accessible to all animation explaining the importance of using appropriate pronouns and the opportunity to create a user account and log-in to access further free content. Creating an account provides an opportunity (for the user and the research team) to record engagement, assess users’ well-being, and track progress through the available content. There are three sections of content in Oneself focused on the priority topics identified through co-design: (1) coming out and doing so safely; (2) managing school, including homophobic, biphobic, or transphobic bullying or similar; and (3) dealing with parents and families, especially unsupportive family members, including parents or caregivers. Oneself’s content focuses on identifying these as topic areas and providing potential resources to assist sexual and gender minority youth in coping with these areas. For instance, Oneself drew on therapeutic concepts such as cognitive reframing, stress reduction, and problem-solving techniques. There is also a section containing relaxation exercises, a section with links to other recommended support and resources, and a downloads section with more detailed techniques and strategies for improving well-being. Conclusions: This study contributes to research by opening up the black box of intervention development. It shows how Oneself is underpinned by a logic that can support future development and evaluation and includes diverse co-designers. More interactive techniques to support well-being would be beneficial for further development. Additional content specific to a wider range of intersecting identities (such as care-experienced Asian sexual and gender minority youth from a minority faith background) would also be beneficial in future Oneself developments. International Registered Report Identifier (IRRID): RR2-10.2196/31036 %M 38772025 %R 10.2196/54586 %U https://formative.jmir.org/2024/1/e54586 %U https://doi.org/10.2196/54586 %U http://www.ncbi.nlm.nih.gov/pubmed/38772025 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e49050 %T A Web-Based Intervention Using "Five Ways to Wellbeing" to Promote Well-Being and Mental Health: Randomized Controlled Trial %A Prydz,Monica Beer %A Czajkowski,Nikolai Olavi %A Eilertsen,Maja %A Røysamb,Espen %A Nes,Ragnhild Bang %+ Promenta Research Centre, Department of Psychology, University of Oslo, Forskningsveien 3 a, PO Box 1020, Oslo, 0315, Norway, 47 95856400, m.b.prydz@psykologi.uio.no %K well-being %K mental health promotion %K intervention %K web based %K low cost %K broad outreach %K framework %K web-based intervention %K randomized controlled trial %K effectiveness %D 2024 %7 20.5.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Compromised well-being and mental health problems pose a significant threat to individuals and societies worldwide. Resource-intensive psychological treatments alone cannot alleviate this burden. There is a need for low-cost, evidence-based interventions aimed at preventing illness and promoting well-being. Five activity domains appear to be linked with well-being promotion across populations: connecting with others, being active, taking notice, learning, and being generous/giving. The activities mentioned are part of the Five Ways to Wellbeing framework and the web-based intervention Five Ways to Wellbeing for All (5waysA). Objective: This randomized controlled trial aims to test the effects of the 5waysA intervention, a web-based, low-cost, well-being–promoting measure targeting the general population. To date, the Five Ways to Wellbeing framework has not been tested in this specific format. The 5waysA intervention comprises 2 webinars and SMS text message reminders delivered over a 10-week period. Methods: In 2021, a total of 969 study participants from various regions across Norway were openly recruited through a web page. They were then randomly assigned to either an intervention group or 1 of 2 waiting list control groups, namely, active or passive. Self-reported life satisfaction (Satisfaction With Life Scale [SWLS]), flourishing (Flourishing Scale [FS]), positive emotions, anxiety, and depression symptoms (Hopkins Symptom Checklist-8 [HSCL-8]) were assessed before the intervention, at 4 weeks into the intervention, and 1-2 weeks after the intervention (over 10 weeks). Data analysis was conducted using linear mixed (multilevel) models. Results: After 10 weeks, 453 participants (171 in the intervention group and 282 in the waiting list control group) were assessed on outcome variables, with a dropout rate of 53.2% (516/969). Results revealed a significantly greater increase in the intervention group compared with the controls for SWLS (b=0.13, 95% CI 0.03-0.23; P=.001), FS (b=0.19, 95% CI 0.08-0.30; P=.001), positive emotions (b=0.43, 95% CI 0.27-0.60; P<.001), and these factors combined into a global well-being measure (b=0.28, CI 0.16-0.39; P<.001). Effect sizes (Cohen d) for the well-being outcomes ranged from 0.30 to 0.49. In addition, a significant decrease in anxiety and depressive symptoms was observed (b=–0.17, 95% CI –0.30 to –0.04; P=.001) with an effect size (Cohen d) of –0.20. Conclusions: The findings suggest that the web-based 5waysA intervention could serve as an effective approach for enhancing well-being and mental health within the general population. This study offers individuals, policy makers, and local stakeholders an accessible and potentially cost-effective well-being intervention that could be easily implemented. Trial Registration: ClinicalTrials.gov NCT04784871; https://clinicaltrials.gov/study/NCT04784871 %M 38767958 %R 10.2196/49050 %U https://mental.jmir.org/2024/1/e49050 %U https://doi.org/10.2196/49050 %U http://www.ncbi.nlm.nih.gov/pubmed/38767958 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e53204 %T Prospective Acceptability of Digital Therapy for Major Depressive Disorder in France: Multicentric Real-Life Study %A Amiot,Odile %A Sauvaget,Anne %A Alamome,Isabelle %A Bulteau,Samuel %A Charpeaud,Thomas %A Clair,Anne-Hélène %A Courtet,Philippe %A Drapier,Dominique %A Haffen,Emmanuel %A Fakra,Eric %A Gaudeau-Bosma,Christian %A Gaillard,Adeline %A Mouchabac,Stéphane %A Pineau,Fanny %A Narboni,Véronique %A Duburcq,Anne %A Lecardeur,Laurent %+ DueL, 8 Quai des Docks, Nice, 06300, France, 33 635568024, laurentlecardeur@gmail.com %K prospective acceptability %K digital health %K depression %K e-mental health %K deprexis %K psychotherapy %D 2024 %7 20.5.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Major depressive disorder is one of the leading causes of disability worldwide. Although most international guidelines recommend psychological and psychosocial interventions as first-line treatment for mild to moderate depression, access remains limited in France due to the limited availability of trained clinicians, high costs for patients in the context of nonreimbursement, and the fear of stigmatization. Therefore, online blended psychological treatment such as Deprexis could improve access to care for people with depression. It has several advantages, such as easy accessibility and scalability, and it is supported by evidence. Objective: This study aims to evaluate the real-life acceptability of Deprexis for people with depression in France outside of a reimbursement pathway. Methods: Deprexis Acceptability Study Measure in Real Life (DARE) was designed as a multicenter cross-sectional study in which Deprexis was offered to any patient meeting the inclusion criteria during the fixed inclusion period (June 2022-March 2023). Inclusion criteria were (1) depression, (2) age between 18 and 65 years, (3) sufficient French language skills, and (4) access to the internet with a device to connect to the Deprexis platform. Exclusion criteria were previous or current diagnoses of bipolar disorder, psychotic symptoms, and suicidal thoughts during the current episode. The primary objective was to measure the prospective acceptability of Deprexis, a new digital therapy. Secondary objectives were to examine differences in acceptability according to patient and clinician characteristics and to identify reasons for refusal. All investigators received video-based training on Deprexis before enrollment to ensure that they all had the same level of information and understanding of the program. Results: A total of 245 patients were eligible (n=159, 64.9% were women and n=138, 56.3% were single). The mean age was 40.7 (SD 14.1) years. A total of 78% (n=191) of the patients had moderate to severe depression (according to the Patient Health Questionnaire-9 [PHQ-9]). More than half of the population had another psychiatric comorbidity (excluding bipolar disorder, psychotic disorders, and suicidal ideation). A total of 33.9% (n=83) of patients accepted the idea of using Deprexis; the main reason for refusal was financial at 83.3% (n=135). Multivariate logistic regression identified factors that might favor the acceptability of Deprexis. Among these, being a couple, being treated with an antidepressant, or having a low severity level favored the acceptance of Deprexis. Conclusions: DARE is the first French study aiming at evaluating the prospective acceptability of digital therapy in the treatment of depression. The main reason for the refusal of Deprexis was financial. DARE will allow better identification of factors influencing acceptability in a natural setting. This study highlights the importance of investigating factors that may be associated with the acceptability of digital interventions, such as marital status, medication use, and severity of depression. %M 38568139 %R 10.2196/53204 %U https://formative.jmir.org/2024/1/e53204 %U https://doi.org/10.2196/53204 %U http://www.ncbi.nlm.nih.gov/pubmed/38568139 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e54595 %T Feasibility of Fit24, a Digital Diabetes Prevention Program for Hispanic Adolescents: Qualitative Evaluation Study %A Soltero,Erica G %A Musaad,Salma M %A O’Connor,Teresia M %A Thompson,Debbe %A Norris,Keith %A Beech,Bettina M %+ USDA/ARS Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine, 1100 Bates Ave, Houston, TX, 77030, United States, 1 602 496 0909, soltero@bcm.edu %K health disparities %K diabetes prevention %K Mexican youth %K physical activity %K sleep %K digital health %D 2024 %7 17.5.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital health interventions are promising for reaching and engaging high-risk youth in disease prevention opportunities; however, few digital prevention interventions have been developed for Hispanic youth, limiting our knowledge of these strategies among this population. Objective: This study qualitatively assessed the feasibility and acceptability of Fit24, a 12-week goal-setting intervention that uses a Fitbit watch (Fitbit Inc) and theoretically grounded SMS text messages to promote physical activity and sleep among Hispanic adolescents (aged between 14 and 16 years) with obesity. Methods: After completing the intervention, a subsample of youth (N=15) participated in an in-depth interview. We categorized the themes into dimensions based on participant perspectives using the Practical, Robust Implementation, and Sustainability Model (PRISM) framework. Results: Participants shared positive perceptions of wearing the Fitbit and receiving SMS text messages. Youth were highly engaged in monitoring their behaviors and perceived increased activity and sleep. Almost all youth organically received social support from a peer or family member and suggested the use of a group chat or team challenge for integrating peers into future interventions. However, most youth also expressed the need to take personal responsibility for the change in their behavior. Barriers that impacted the feasibility of the study included the skin-irritating material on the Fitbit watch band and environmental barriers (eg, lack of resources and school schedules), that limited participation in activity suggestions. Additionally, sync issues with the Fitbit limited the transmission of data, leading to inaccurate feedback. Conclusions: Fit24 is a promising approach for engaging Hispanic youth in a diabetes prevention program. Strategies are needed to address technical issues with the Fitbit and environmental issues such as message timing. While integrating peer social support may be desired by some, peer support strategies should be mindful of youth’s desire to foster personal motivation for behavior change. Findings from this study will inform future diabetes prevention trials of Fit24 and other digital health interventions for high-risk pediatric populations. %M 38758584 %R 10.2196/54595 %U https://formative.jmir.org/2024/1/e54595 %U https://doi.org/10.2196/54595 %U http://www.ncbi.nlm.nih.gov/pubmed/38758584 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e55731 %T The Impact of Behavior Change Counseling Delivered via a Digital Health Tool Versus Routine Care Among Adolescents With Obesity: Pilot Randomized Feasibility Study %A Kepper,Maura %A Walsh-Bailey,Callie %A Miller,Zoe M %A Zhao,Min %A Zucker,Kianna %A Gacad,Angeline %A Herrick,Cynthia %A White,Neil H %A Brownson,Ross C %A Foraker,Randi E %+ Prevention Research Center, Brown School, Washington University in St. Louis, One Brookings Dr, St. Louis, MO, 63130, United States, 1 3149350142, kepperm@wustl.edu %K digital health %K obesity %K clinical care %K adolescents %K physical activity %K diet %K clinical trial %D 2024 %7 17.5.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Youth overweight and obesity is a public health crisis and increases the risk of poor cardiovascular health (CVH) and chronic disease. Health care providers play a key role in weight management, yet few tools exist to support providers in delivering tailored evidence-based behavior change interventions to patients. Objective: The goal of this pilot randomized feasibility study was to determine the feasibility of implementing the Patient-Centered Real-Time Intervention (PREVENT) tool in clinical settings, generate implementation data to inform scale-up, and gather preliminary effectiveness data. Methods: A pilot randomized clinical trial was conducted to examine the feasibility, implementation, and preliminary impact of PREVENT on patient knowledge, motivation, behaviors, and CVH outcomes. The study took place in a multidisciplinary obesity management clinic at a children’s hospital within an academic medical center. A total of 36 patients aged 12 to 18 years were randomized to use PREVENT during their routine visit (n=18, 50%) or usual care control (n=18, 50%). PREVENT is a digital health tool designed for use by providers to engage patients in behavior change education and goal setting and provides resources to support change. Patient electronic health record and self-report behavior data were collected at baseline and 3 months after the intervention. Implementation data were collected via PREVENT, direct observation, surveys, and interviews. We conducted quantitative, qualitative, and mixed methods analyses to evaluate pretest-posttest patient changes and implementation data. Results: PREVENT was feasible, acceptable, easy to understand, and helpful to patients. Although not statistically significant, only PREVENT patients increased their motivation to change their behaviors as well as their knowledge of ways to improve heart health and of resources. Compared to the control group, PREVENT patients significantly improved their overall CVH and blood pressure (P<.05). Conclusions: Digital tools can support the delivery of behavior change counseling in clinical settings to increase knowledge and motivate patients to change their behaviors. An appropriately powered trial is necessary to determine the impact of PREVENT on CVH behaviors and outcomes. Trial Registration: ClinicalTrials.gov NCT06121193; https://www.clinicaltrials.gov/study/NCT06121193 %M 38758581 %R 10.2196/55731 %U https://formative.jmir.org/2024/1/e55731 %U https://doi.org/10.2196/55731 %U http://www.ncbi.nlm.nih.gov/pubmed/38758581 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e55483 %T Economic Evaluation of a Web Application Implemented in Primary Care for the Treatment of Depression in Patients With Type 2 Diabetes Mellitus: Multicenter Randomized Controlled Trial %A Varela-Moreno,Esperanza %A Anarte-Ortiz,Maria Teresa %A Jodar-Sanchez,Francisco %A Garcia-Palacios,Azucena %A Monreal-Bartolomé,Alicia %A Gili,Margalida %A García-Campayo,Javier %A Mayoral-Cleries,Fermin %+ Department of Applied Economics, Faculty of Economics and Business Administration, University of Malaga, C. El Ejido, 6, Malaga, 29071, Spain, 34 951976620, fjodar@uma.es %K depression %K depressive %K type 2 %K diabetes %K diabetic %K type 2 diabetes mellitus %K eHealth %K web-based intervention %K efficacy %K economic evaluation %K cost-effectiveness %K cost-utility %K randomized controlled trial %K RCT %K randomized %K controlled trial %K controlled trials %K cost %K costs %K economic %K economics %K web based %K internet based %K CBT %K psychotherapy %K cognitive behavioral therapy %K cognitive behavioral therapy %K mental health %D 2024 %7 16.5.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Depressive disorder and type 2 diabetes mellitus (T2DM) are prevalent in primary care (PC). Pharmacological treatment, despite controversy, is commonly chosen due to resource limitations and difficulties in accessing face-to-face interventions. Depression significantly impacts various aspects of a person’s life, affecting adherence to medical prescriptions and glycemic control and leading to future complications and increased health care costs. To address these challenges, information and communication technologies (eg, eHealth) have been introduced, showing promise in improving treatment continuity and accessibility. However, while eHealth programs have demonstrated effectiveness in alleviating depressive symptoms, evidence regarding glycemic control remains inconclusive. This randomized controlled trial aimed to test the efficacy of a low-intensity psychological intervention via a web app for mild-moderate depressive symptoms in individuals with T2DM compared with treatment as usual (TAU) in PC. Objective: This study aimed to analyze the cost-effectiveness and cost-utility of a web-based psychological intervention to treat depressive symptomatology in people with T2DM compared with TAU in a PC setting. Methods: A multicenter randomized controlled trial was conducted with 49 patients with T2DM, depressive symptoms of moderate severity, and glycosylated hemoglobin (HbA1c) of 7.47% in PC settings. Patients were randomized to TAU (n=27) or a web-based psychological treatment group (n=22). This web-based treatment consisted of cognitive behavioral therapy, improvement of diabetes self-care behaviors, and mindfulness. Cost-effectiveness analysis for the improvement of depressive symptomatology was conducted based on reductions in 3, 5, or 50 points on the Patient Health Questionnaire–9 (PHQ-9). The efficacy of diabetes control was estimated based on a 0.5% reduction in HbA1c levels. Follow-up was performed at 3 and 6 months. The cost-utility analysis was performed based on quality-adjusted life years. Results: Efficacy analysis showed that the web-based treatment program was more effective in improving depressive symptoms than TAU but showed only a slight improvement in HbA1c. Incremental cost-effectiveness ratios of 186.76 for a 3-point reduction in PHQ-9 and 206.31 for reductions of 5 and 50 percentage points were obtained. In contrast, the incremental cost-effectiveness ratio for improving HbA1c levels amounted to €1510.90 (€1=US $1.18 in 2018) per participant. The incremental cost-utility ratio resulted in €4119.33 per quality-adjusted life year gained. Conclusions: The intervention, using web-based modules incorporating cognitive behavioral therapy tools, diabetes self-care promotion, and mindfulness, effectively reduced depressive symptoms and enhanced glycemic control in patients with T2DM. Notably, it demonstrated clinical efficacy and economic efficiency. This supports the idea that eHealth interventions not only benefit patients clinically but also offer cost-effectiveness for health care systems. The study emphasizes the importance of including specific modules to enhance diabetes self-care behaviors in future web-based psychological interventions, emphasizing personalization and adaptation for this population. Trial Registration: ClinicalTrials.gov NCT03426709; https://clinicaltrials.gov/study/NCT03426709 International Registered Report Identifier (IRRID): RR2-10.1186/S12888-019-2037-3 %M 38754101 %R 10.2196/55483 %U https://mhealth.jmir.org/2024/1/e55483 %U https://doi.org/10.2196/55483 %U http://www.ncbi.nlm.nih.gov/pubmed/38754101 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e50098 %T A Digital Behavioral Activation Intervention (JuNEX) for Pregnant Women With Subclinical Depression Symptoms: Explorative Co-Design Study %A Mancinelli,Elisa %A Gabrielli,Silvia %A Salcuni,Silvia %+ Department of Developmental and Socialization Psychology, University of Padova, Via Venezia 8, Padova, 35131, Italy, 39 3342799698, elisa.mancinelli@phd.unipd.it %K digital intervention %K behavioral activation %K feasibility %K pregnancy %K subclinical depression symptoms %D 2024 %7 16.5.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Digital interventions are gaining increasing interest due to their structured nature, ready availability, and self-administered capabilities. Perinatal women have expressed a desire for such interventions. In this regard, behavioral activation interventions may be particularly suitable for digital administration. Objective: This study aims to exploratorily investigate and compare the feasibility of the internet-based self-help guided versus unguided version of the Brief Behavioral Activation Treatment for Depression-Revised, an empirically supported in-person behavioral activation protocol, targeting pregnant women with subclinical depression symptoms. A user-centered design is used, whereby data are collected with the intent of evaluating how to adjust the intervention in line with pregnant women’s needs. Usability and user engagement were evaluated. Methods: A total of 11 Italian pregnant women with subclinical depressive symptoms based on the Patient Health Questionnaire-9 (scoring<15) participated in this study; of them, 6 (55%) women were randomly assigned to the guided group (age: mean 32.17, SD 4.36 years) and 5 (45%) to the unguided group (age: mean 31, SD 4.95 years). The Moodle platform was used to deliver the interventions in an e-learning format. It consisted of 6 core modules and 3 optional modules; the latter aimed at revising the content of the former. In the guided group, each woman had weekly chats with their assigned human guide to support them in the homework revisions. The intervention content included text, pictures, and videos. Semistructured interviews were conducted, and descriptive statistics were analyzed. Results: Collectively, the data suggest that the guided intervention was better accepted than the unguided one. However, the high rates of dropout (at T6: guided group: 3/6, 50%; unguided: 4/5, 80%) suggest that a digital replica of Behavioral Activation Treatment for Depression-Revised may not be feasible in an e-learning format. The reduced usability of the platform used was reported, and homework was perceived as too time-consuming and effort-intensive. Moreover, the 6 core modules were deemed sufficient for the intervention’s goals, suggesting that the 3 optional modules could be eliminated. Nevertheless, participants from both groups expressed satisfaction with the content and found it relevant to their pregnancy experiences. Conclusions: Overall, the findings have emphasized both the intervention’s merits and shortcomings. Results highlight the unsuitability of replicating an in-person protocol digitally as well as of the use of nonprofessional tools for the implementation of self-help interventions, ultimately making the intervention not feasible. Pregnant women have nonetheless expressed a desire to receive psychological support and commented on the possibilities of digital psychosocial supports, particularly those that are app-based. The information collected and the issues identified here are important to guide the development and co-design of a more refined platform for the intervention deployment and to tailor the intervention’s content to pregnant women’s needs. %M 38753421 %R 10.2196/50098 %U https://humanfactors.jmir.org/2024/1/e50098 %U https://doi.org/10.2196/50098 %U http://www.ncbi.nlm.nih.gov/pubmed/38753421 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e56198 %T An Internet-Based Intervention to Increase the Ability of Lesbian, Gay, and Bisexual People to Cope With Adverse Events: Single-Group Feasibility Study %A Isbășoiu,Andreea Bogdana %A Sava,Florin Alin %A Larsen,Torill M B %A Anderssen,Norman %A Rotaru,Tudor-Stefan %A Rusu,Andrei %A Sălăgean,Nastasia %A Tulbure,Bogdan Tudor %+ Department of Psychology, West University of Timisoara, 4 Vasile Parvan Bvd., Timisoara, 300223, Romania, 40 256592270, florin.sava@e-uvt.ro %K acceptance and commitment therapy %K anxiety %K depression %K PTSD %K LGBTQ+ %K online interventions %K transdiagnostic %K prevention %D 2024 %7 15.5.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Lesbian, gay, bisexual, transgender, and queer (LGBTQ+) people are at higher risk of mental health problems due to widespread hetero- and cisnormativity, including negative public attitudes toward the LGBTQ+ community. In addition to combating social exclusion at the societal level, strengthening the coping abilities of young LGBTQ+ people is an important goal. Objective: In this transdiagnostic feasibility study, we tested a 6-week internet intervention program designed to increase the ability of nonclinical LGBTQ+ participants to cope with adverse events in their daily lives. The program was based on acceptance and commitment therapy principles. Methods: The program consists of 6 web-based modules and low-intensity assistance for homework provided by a single care provider asynchronously. The design was a single-group assignment of 15 self-identified LGB community members who agreed to participate in an open trial with a single group (pre- and postintervention design). Results: Before starting the program, participants found the intervention credible and expressed high satisfaction at the end of the intervention. Treatment adherence, operationalized by the percentage of completed homework assignments (32/36, 88%) was also high. When we compared participants’ pre- and postintervention scores, we found a significant decrease in clinical symptoms of depression (Cohen d=0.44, 90% CI 0.09-0.80), social phobia (d=0.39, 90% CI 0.07-0.72), and posttraumatic stress disorder (d=0.30, 90% CI 0.04-0.55). There was also a significant improvement in the level of self-acceptance and behavioral effectiveness (d=0.64, 90% CI 0.28-0.99) and a significant decrease in the tendency to avoid negative internal experiences (d=0.38, 90% CI 0.09-0.66). The level of general anxiety disorder (P=.11; d=0.29, 90% CI –0.10 to 0.68) and alcohol consumption (P=.35; d=–0.06, 90% CI –0.31 to 0.19) were the only 2 outcomes for which the results were not statistically significant. Conclusions: The proposed web-based acceptance and commitment therapy program, designed to help LGBTQ+ participants better manage emotional difficulties and become more resilient, represents a promising therapeutic tool. The program could be further tested with more participants to ensure its efficacy and effectiveness. Trial Registration: ClinicalTrials.gov NCT05514964; https://clinicaltrials.gov/study/NCT05514964 %M 38749024 %R 10.2196/56198 %U https://formative.jmir.org/2024/1/e56198 %U https://doi.org/10.2196/56198 %U http://www.ncbi.nlm.nih.gov/pubmed/38749024 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e59208 %T How to Enhance Adherence in Patients with Nonalcoholic Fatty Liver Disease: A Thought-Provoking Issue %A Liu,Chunlan %A Zhou,Run %A Shi,Junping %+ Department of Infectious Disease and Hepatology, The Affiliated Hospital of Hangzhou Normal University, Hangzhou Normal University Jinhua Road Campus, 120 Jinhua Road, Hangzhou, 311121, China, 86 13957121199, 20131004@hznu.edu.cn %K NAFLD %K adherence %K digital therapeutics %K lifestyle modification %K mobile health %K nonalcoholic fatty liver disease %K self-management %K randomized controlled trial %D 2024 %7 14.5.2024 %9 Letter to the Editor %J J Med Internet Res %G English %X %M 38743941 %R 10.2196/59208 %U https://www.jmir.org/2024/1/e59208 %U https://doi.org/10.2196/59208 %U http://www.ncbi.nlm.nih.gov/pubmed/38743941 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e50430 %T A Digital Health Intervention Platform (Active and Independent Management System) to Enhance the Rehabilitation Experience for Orthopedic Joint Replacement Patients: Usability Evaluation Study %A Papadopoulos,Petros %A Soflano,Mario %A Connolly,Thomas %+ University of Strathclyde, 26 Richmond Street, Glasgow, G1 1XH, United Kingdom, 44 7920756076, petros.papadopoulos@gmail.com %K mobile health %K mHealth %K digital health intervention %K total knee replacement %K TKR %K total hip replacement %K THR %K dynamic hip screw %K DHS %K rehabilitation %K usability %K mobile phone %D 2024 %7 14.5.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Optimal rehabilitation programs for orthopedic joint replacement patients ensure faster return to function, earlier discharge from hospital, and improved patient satisfaction. Digital health interventions show promise as a supporting tool for re-enablement. Objective: The main goal of this mixed methods study was to examine the usability of the AIMS platform from the perspectives of both patients and clinicians. The aim of this study was to evaluate a re-enablement platform that we have developed that uses a holistic systems approach to address the de-enablement that occurs in hospitalized inpatients, with the older adult population most at risk. The Active and Independent Management System (AIMS) platform is anticipated to deliver improved patient participation in recovery and self-management through education and the ability to track rehabilitation progression in hospital and after patient discharge. Methods: Two well-known instruments were used to measure usability: the System Usability Scale (SUS) with 10 items and, for finer granularity, the User Experience Questionnaire (UEQ) with 26 items. In all, 26 physiotherapists and health care professionals evaluated the AIMS clinical portal; and 44 patients in hospital for total knee replacement, total hip replacement, or dynamic hip screw implant evaluated the AIMS app. Results: For the AIMS clinical portal, the mean SUS score obtained was 82.88 (SD 13.07, median 86.25), which would be considered good/excellent according to a validated adjective rating scale. For the UEQ, the means of the normalized scores (range −3 to +3) were as follows: attractiveness=2.683 (SD 0.100), perspicuity=2.775 (SD 0.150), efficiency=2.775 (SD 0.130), dependability=2.300 (SD 0.080), stimulation=1.950 (SD 0.120), and novelty=1.625 (SD 0.090). All dimensions were thus classed as excellent against the benchmarks, confirming the results from the SUS questionnaire. For the AIMS app, the mean SUS score obtained was 74.41 (SD 10.26), with a median of 77.50, which would be considered good according to the aforementioned adjective rating scale. For the UEQ, the means of the normalized scores were as follows: attractiveness=2.733 (SD 0.070), perspicuity=2.900 (SD 0.060), efficiency=2.800 (SD 0.090), dependability=2.425 (SD 0.060), stimulation=2.200 (SD 0.010), and novelty=1.450 (0.260). All dimensions were thus classed as excellent against the benchmarks (with the exception of novelty, which was classed as good), providing slightly better results than the SUS questionnaire. Conclusions: The study has shown that both the AIMS clinical portal and the AIMS app have good to excellent usability scores, and the platform provides a solid foundation for the next phase of research, which will involve evaluating the effectiveness of the platform in improving patient outcomes after total knee replacement, total hip replacement, or dynamic hip screw. %M 38743479 %R 10.2196/50430 %U https://humanfactors.jmir.org/2024/1/e50430 %U https://doi.org/10.2196/50430 %U http://www.ncbi.nlm.nih.gov/pubmed/38743479 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e44973 %T Effect of Adding Personalized Instant Messaging Apps to a Brief Smoking Cessation Model in Community Smokers in Hong Kong: Pragmatic Randomized Clinical Trial %A Wu,Yongda Socrates %A Cheung,Yee Tak Derek %A Lee,Jay Jung Jae %A Wong,Carlos King Ho %A Ho,Sai Yin %A Li,William Ho Cheung %A Yao,Ying %A Lam,Tai Hing %A Wang,Man Ping %+ School of Nursing, The University of Hong Kong, 5/F, Academic Building, 3 Sassoon Road, Pokfulam, Hong Kong, China (Hong Kong), 852 39176636, mpwang@hku.hk %K instant messaging %K text messaging %K chatting %K smoking cessation %K COVID-19 %K community smoker %D 2024 %7 13.5.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: While text messaging has proven effective for smoking cessation (SC), engagement in the intervention remains suboptimal. Objective: This study aims to evaluate whether using more interactive and adaptive instant messaging (IM) apps on smartphones, which enable personalization and chatting with SC advisors, can enhance SC outcomes beyond the provision of brief SC advice and active referral (AR) to SC services. Methods: From December 2018 to November 2019, we proactively recruited 700 adult Chinese daily cigarette users in Hong Kong. Participants were randomized in a 1:1 ratio. At baseline, all participants received face-to-face brief advice on SC. Additionally, they were introduced to local SC services and assisted in selecting one. The intervention group received an additional 26 personalized regular messages and access to interactive chatting through IM apps for 3 months. The regular messages aimed to enhance self-efficacy, social support, and behavioral capacity for quitting, as well as to clarify outcome expectations related to cessation. We developed 3 sets of messages tailored to the planned quit date (within 30 days, 60 days, and undecided). Participants in the intervention group could initiate chatting with SC advisors on IM themselves or through prompts from regular messages or proactive inquiries from SC advisors. The control group received 26 SMS text messages focusing on general health. The primary outcomes were smoking abstinence validated by carbon monoxide levels of <4 parts per million at 6 and 12 months after the start of the intervention. Results: Of the participants, 505/700 (72.1%) were male, and 450/648 (69.4%) were aged 40 or above. Planning to quit within 30 days was reported by 500/648 (77.2%) participants, with fewer intervention group members (124/332, 37.3%) reporting previous quit attempts compared with the control group (152/335, 45.4%; P=.04). At the 6- and 12-month follow-ups (with retention rates of 456/700, 65.1%, and 446/700, 63.7%, respectively), validated abstinence rates were comparable between the intervention (14/350, 4.0%, and 19/350, 5.4%) and control (11/350, 3.1% and 21/350, 6.0%) groups. Compared with the control group, the intervention group reported greater utilization of SC services at 12 months (RR 1.26, 95% CI 1.01-1.56). Within the intervention group, engaging in chat sessions with SC advisors predicted better validated abstinence at 6 months (RR 3.29, 95% CI 1.13-9.63) and any use of SC services (RR 1.66, 95% CI 1.14-2.43 at 6 months; RR 1.67, 95% CI 1.26-2.23 at 12 months). Conclusions: An IM-based intervention, providing support and assistance alongside brief SC advice and AR, did not yield further increases in quitting rates but did encourage the utilization of SC services. Future research could explore whether enhanced SC service utilization leads to improved long-term SC outcomes. Trial Registration: ClinicalTrials.gov NCT03800719; https://clinicaltrials.gov/ct2/show/NCT03800719 %M 38739429 %R 10.2196/44973 %U https://www.jmir.org/2024/1/e44973 %U https://doi.org/10.2196/44973 %U http://www.ncbi.nlm.nih.gov/pubmed/38739429 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e55569 %T A Digital Cognitive-Physical Intervention for Attention-Deficit/Hyperactivity Disorder: Randomized Controlled Trial %A Zhao,Licong %A Agazzi,Heather %A Du,Yasong %A Meng,Hongdao %A Maku,Renya %A Li,Ke %A Aspinall,Peter %A Garvan,Cynthia Wilson %A Fang,Shuanfeng %+ Department of Child Healthcare, Children’s Hospital Affiliated to Zhengzhou University, 33 Longhu Waihuan East Road, Zhengdong New District, Zhengzhou, 450018, China, 86 0371 85515939, fangshuanfeng@126.com %K school-age children %K cognitive training %K exercise therapy %K gamification %K ADHD %K attention deficit %K attention-deficit/hyperactivity disorder %K RCT %K randomized controlled trial %K executive function %K digital intervention %K AR %K augmented reality %D 2024 %7 10.5.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders among children. Pharmacotherapy has been the primary treatment for ADHD, supplemented by behavioral interventions. Digital and exercise interventions are promising nonpharmacologic approaches for enhancing the physical and psychological health of children with ADHD. However, the combined impact of digital and exercise therapies remains unclear. Objective: The aim of this study was to determine whether BrainFit, a novel digital intervention combining gamified cognitive and exercise training, is efficacious in reducing ADHD symptoms and executive function (EF) among school-aged children with ADHD. Methods: This 4-week prospective randomized controlled trial included 90 children (6-12 years old) who visited the ADHD outpatient clinic and met the diagnostic criteria for ADHD. The participants were randomized (1:1) to the BrainFit intervention (n=44) or a waitlist control (n=46) between March and August 2022. The intervention consisted of 12 30-minute sessions delivered on an iPad over 4 weeks with 3 sessions per week (Monday, Wednesday, and Friday after school) under the supervision of trained staff. The primary outcomes were parent-rated symptoms of attention and hyperactivity assessed according to the Swanson, Nolan, and Pelham questionnaire (SNAP-IV) rating scale and EF skills assessed by the Behavior Rating Inventory of Executive Function (BRIEF) scale, evaluated pre and post intervention. Intention-to-treat analysis was performed on 80 children after attrition. A nonparametric resampling-based permutation test was used for hypothesis testing of intervention effects. Results: Among the 145 children who met the inclusion criteria, 90 consented and were randomized; ultimately, 80 (88.9%) children completed the study and were included in the analysis. The participants’ average age was 8.4 (SD 1.3) years, including 63 (78.8%) male participants. The most common ADHD subtype was hyperactive/impulsive (54/80, 68%) and 23 (29%) children had severe symptoms. At the endpoint of the study, the BrainFit intervention group had a significantly larger improvement in total ADHD symptoms (SNAP-IV total score) as compared to those in the control group (β=–12.203, 95% CI –17.882 to –6.523; P<.001), owing to lower scores on the subscales Inattention (β=–3.966, 95% CI –6.285 to –1.647; P<.001), Hyperactivity/Impulsivity (β=–5.735, 95% CI –8.334 to –3.137; P<.001), and Oppositional Defiant Disorder (β=–2.995, 95% CI –4.857 to –1.132; P=.002). The intervention was associated with significant reduction in the Metacognition Index (β=–6.312, 95% CI –10.973 to –1.650; P=.006) and Global Executive Composite (β=–5.952, 95% CI –10.214 to –1.690; P=.003) on the BRIEF. No severe intervention-related adverse events were reported. Conclusions: This novel digital cognitive-physical intervention was efficacious in school-age children with ADHD. A larger multicenter effectiveness trial with longer follow-up is warranted to confirm these findings and to assess the durability of treatment effects. Trial Registration: Chinese Clinical Trial Register ChiCTR2300070521; https://www.chictr.org.cn/showproj.html?proj=177806 %M 38728075 %R 10.2196/55569 %U https://www.jmir.org/2024/1/e55569 %U https://doi.org/10.2196/55569 %U http://www.ncbi.nlm.nih.gov/pubmed/38728075 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e52369 %T Feasibility and Acceptability of a Mobile App–Based TEAM-CBT (Testing Empathy Assessment Methods–Cognitive Behavioral Therapy) Intervention (Feeling Good) for Depression: Secondary Data Analysis %A Bisconti,Nicholas %A Odier,Mackenzie %A Becker,Matthew %A Bullock,Kim %+ PGSP-Stanford PsyD. Consortium, 401 Quarry Rd, Palo Alto, CA, 94304, United States, 1 6506449946, nbisco@stanford.edu %K depression %K mobile health %K mHealth %K cognitive behavioral therapy %K mobile phone %D 2024 %7 10.5.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: The Feeling Good App is an automated stand-alone digital mobile mental health tool currently undergoing beta testing with the goal of providing evidence-informed self-help lessons and exercises to help individuals reduce depressive symptoms without guidance from a mental health provider. Users work through intensive basic training (IBT) and ongoing training models that provide education regarding cognitive behavioral therapy principles from a smartphone. Objective: The key objective of this study was to perform a nonsponsored third-party academic assessment of an industry-generated data set; this data set focused on the safety, feasibility, and accessibility of a commercial automated digital mobile mental health app that was developed to reduce feelings associated with depression. Methods: The Feeling Good App development team created a waitlist cohort crossover design and measured symptoms of depression and anxiety using the Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, and an app-specific measure of negative feelings called the 7 Dimension Emotion Slider (7-DES). The waitlist cohort crossover design divided the participants into 2 groups, where 48.6% (141/290) of the participants were given immediate access to the apps, while 51.4% (149/290) were placed on a 2-week waitlist before being given access to the app. Data collected by the Feeling Good App development team were deidentified and provided to the authors of this paper for analysis through a nonsponsored university data use agreement. All quantitative data were analyzed using SPSS Statistics (version 28.0; IBM Corp). Descriptive statistics were calculated for demographic variables. Feasibility and acceptability were descriptively assessed. All participants included in the quantitative data were given access to the Feeling Good App; this study did not include a control group. Results: In terms of safety, there was no statistically significant change in suicidality from preintervention to postintervention time points (t288=0.0; P>.99), and there was a statistically significant decrease in hopelessness from preintervention to postintervention time points (F289=30.16; P<.01). In terms of acceptability, 72.2% (166/230) of the users who started the initial 2-day IBT went on to complete it, while 34.8% (80/230) of the users who started IBT completed the entirety of the apps’ 4-week protocol (150/230, 65.22% dropout rate over 4 weeks). Conclusions: This study is the first reported proof-of-concept evaluation of the Feeling Good App in terms of safety, feasibility, and statistical trends within the data set. It demonstrates a feasible and novel approach to industry and academic collaboration in the process of developing a digital mental health technology translated from an existing evidence-informed treatment. The results support the prototype app as safe for a select nonclinical population. The app had acceptable levels of engagement and dropouts throughout the intervention. Those who stay engaged showed reductions in symptom severity of depression warranting further investigation of the app’s efficacy. %M 38728080 %R 10.2196/52369 %U https://mental.jmir.org/2024/1/e52369 %U https://doi.org/10.2196/52369 %U http://www.ncbi.nlm.nih.gov/pubmed/38728080 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e45115 %T Facilitators of and Barriers to the Use of a Digital Self-Management Service for Diagnostic Testing: Focus Group Study With Potential Users %A Schnoor,Kyma %A Talboom-Kamp,Esther P W A %A Hajtić,Muamer %A Chavannes,Niels H %A Versluis,Anke %+ Department of Public Health and Primary Care, Leiden University Medical Center, Hippocratespad 21, Leiden, Netherlands, 31 71526 8433, k.schnoor@lumc.nl %K eHealth %K usability %K self-management %K diagnostic test service %K diagnostic %K testing %K test service %K perspective %K focus group %K user need %K user testing %K implementation %K qualitative %K test result %K laboratory test %K laboratory result %D 2024 %7 10.5.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Health care lags in digital transformation, despite the potential of technology to improve the well-being of individuals. The COVID-19 pandemic has accelerated the uptake of technology in health care and increased individuals’ willingness to perform self-management using technology. A web-based service, Directlab Online, provides consumers with direct digital access to diagnostic test packages, which can digitally support the self-management of health. Objective: This study aims to identify the facilitators, barriers, and needs of Directlab Online, a self-management service for web-based access to diagnostic testing. Methods: A qualitative method was used from a potential user’s perspective. The needs and future needs for, facilitators of, and barriers to the use of Directlab Online were evaluated. Semistructured focus group meetings were conducted in 2022. Two focus groups were focused on sexually transmitted infection test packages and 2 were focused on prevention test packages. Data analysis was performed according to the principles of the Framework Method. The Consolidated Framework for Implementation Research was used to categorize the facilitators and barriers. Results: In total, 19 participants, with a mean age of 34.32 (SD 14.70) years, participated in the focus groups. Important barriers were a lack of privacy information, too much and difficult information, and a commercial appearance. Important facilitators were the right amount of information, the right kind of tests, and the involvement of a health care professional. The need for a service such as Directlab Online was to ensure its availability for users’ health and to maintain their health. Conclusions: According to the participants, facilitators and barriers were comprehension of the information, the goal of the website, and the overall appearance of the service. Although the service was developed in cocreation with health care professionals and users, the needs did not align. The users preferred understandable and adequate, but not excessive, information. In addition, they preferred other types of tests to be available on the service. For future research, it would be beneficial to focus on cocreation between the involved medical professionals and users to develop, improve, and implement a service such as Directlab Online. %M 38728071 %R 10.2196/45115 %U https://humanfactors.jmir.org/2024/1/e45115 %U https://doi.org/10.2196/45115 %U http://www.ncbi.nlm.nih.gov/pubmed/38728071 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55238 %T Evaluating and Enhancing an Educational Intervention to Reduce Smallholder Farmers’ Exposure to Pesticides in Uganda Through a Digital, Systematic Approach to Behavior Change: Protocol for a Cluster-Randomized Controlled Trial %A Ssekkadde,Peter %A Tomberge,Vica Marie Jelena %A Brugger,Curdin %A Atuhaire,Aggrey %A Dalvie,Mohamed Aqiel %A Rother,Hanna-Andrea %A Röösli,Martin %A Inauen,Jennifer %A Fuhrimann,Samuel %+ Swiss Tropical and Public Health Institute, Kreuzstrasse 2, Allschwil, 4123, Switzerland, 41 762010833, samuel.fuhrimann@swisstph.ch %K smallholder farmers %K knowledge %K attitude %K practice %K behavior change %K psychosocial determinants of behavior %K health %K education %K pesticide exposure %K SMS text messages %D 2024 %7 8.5.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Smallholder farmers receive educational interventions on safe pesticide handling by governmental agencies, industries, or nongovernmental organizations to reduce exposure risks. However, existing educational interventions have limited effects on changing behaviors. Targeting psychosocial determinants of behavior change in educational interventions through theory- and evidence-based approaches may enhance their effectiveness. Objective: We aim at describing the intervention development and study design of a 3-arm cluster-randomized controlled trial to assess the effects in improving safe pesticide handling and reducing pesticide exposure of (1) an existing educational intervention and (2) a newly developed SMS text messaging intervention based on the Risks, Attitudes, Norms, Abilities, and Self-regulation (RANAS) behavior change approach. Methods: We enrolled 539 Ugandan smallholder farmers in 12 clusters (subcounties). The clusters, each with 45 farmers, were randomly allocated to one of the three arms: (1) educational intervention, (2) educational intervention+RANAS-based SMS text messages, or (3) control group. The educational intervention comprised a 2-day workshop that targeted multiple aspects of safe pesticide handling, whereas the SMS text messages targeted the use of personal protective equipment (PPE) and were based on the RANAS approach. For intervention development in this study, this approach includes identifying psychosocial determinants of PPE use at baseline and selecting behavior change techniques to target them in SMS text messages. The primary outcomes of the study are (1) pesticide knowledge, attitude, and practice scores indicating performance throughout the educational intervention; and (2) frequency of PPE use. Secondary outcomes are the RANAS-based behavioral determinants of PPE use, the frequency of glove use, algorithm-based pesticide exposure intensity scores, and signs and symptoms of pesticide poisoning. The outcomes were assessed in structured interviews before the intervention (baseline) and at the 12-month follow-up. The effect of the interventions among the arms will be analyzed using the intervention arms and baseline measures as predictors and the follow-up measures as outcomes in linear multivariable mixed models including the clusters as random effects. The mediating psychosocial determinants of the interventions will be assessed in multiple mediation models. Results: The study was conducted from 2020 to 2021—baseline interviews were conducted in October 2020, and the educational intervention was delivered in November 2020. The RANAS-based SMS text messages were developed based on the baseline data for relevant behavioral determinants of PPE use and sent between February 2021 and September 2021. Follow-up interviews were conducted in October 2021. Overall, 539 farmers were enrolled in the study at baseline; 8.3% (45/539) were lost to follow-up by the end of the study. Conclusions: This study will contribute to a better understanding of the effectiveness and behavior change mechanisms of educational interventions by using an experimental, cluster-randomized study design to improve pesticide handling among smallholder farmers. Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN) 18237656; https://doi.org/10.1186/ISRCTN18237656 International Registered Report Identifier (IRRID): DERR1-10.2196/55238 %M 38718387 %R 10.2196/55238 %U https://www.researchprotocols.org/2024/1/e55238 %U https://doi.org/10.2196/55238 %U http://www.ncbi.nlm.nih.gov/pubmed/38718387 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55374 %T Efficacy of the iJobs Web-Based Psychoeducational Intervention to Improve Job Search Behavior and Promote Mental Health Among Unemployed People: Protocol for a Waitlist Randomized Controlled Trial %A Bodnaru,Alexandra %A Rusu,Andrei %A Vîrgă,Delia %A Van den Broeck,Anja %A Blonk,Roland W B %A Trancă,Loredana Marcela %A Iliescu,Dragoș %+ Department of Psychology, West University of Timișoara, 4, Vasile Pârvan Boulevard, Timișoara, 300223, Romania, 40 727977093, alexandra.bodnaru@e-uvt.ro %K iJobs %K JOBS II program %K employability %K internet intervention %K randomized-controlled trial %D 2024 %7 8.5.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Unemployment affects millions of people worldwide and, beyond its economic impact, has severe implications for people’s well-being and mental health. Different programs have been developed in response to this phenomenon, but to date, job-search interventions have proved to be most effective, especially the JOBS II program. The JOBS II program proved not only to be effective for re-employment but also has a positive impact on beneficiaries’ mental health (ie, reduces anxiety or depression). However, by now, this evidence-based program has been delivered only on site in the various countries where it was implemented. In the digital era, web-based alternatives to such programs are highly needed because they have the advantages of scalability and cost-effectiveness. Objective: In this context, we aim to investigate the efficacy of iJobs, the web-based adaptation of the JOBS II program, on job-search intensity and effort, the quality of job-search behaviors, and job-search self-efficacy. Further, 1 month after the intervention, we will also assess the employment status and the satisfaction with the job (if applicable). This study will also investigate the effect of iJobs on well-being and mental health (ie, anxiety and depression). Methods: This study is a 2-arm randomized controlled trial. The 2 independent groups (intervention vs waiting list control group) will be crossed with 3 measurement times (ie, baseline, the postintervention time point, and 1-month follow-up). The design will be a 2 (intervention vs control) × 3 (baseline, the postintervention time point, and 1-month follow-up) factorial design. iJobs is a 2-week intervention consisting of 6 modules: an introductive module and 5 modules adapted from the original JOBS II program to the web-based setting and Romanian population. The web-based intervention also has a human component, as beneficiaries receive personalized written feedback after each module on the platform from a team of psychologists involved in the project. Results: The enrollment of study participants started in June 2023 and is expected to end in May 2024. The data collection is expected to be completed by July 2024. The results are expected to be submitted for publication in the summer of 2024. Conclusions: This study is the first large-scale randomized controlled trial aiming to test the efficacy of a web-based adaptation of the JOBS II program. If our results support the efficacy of iJobs, they will offer the premise for it to become an evidence-based, accessible alternative for unemployed people in Romania and might be implemented in other countries. Trial Registration: ClinicalTrials.gov NCT05962554; https://clinicaltrials.gov/study/NCT05962554 International Registered Report Identifier (IRRID): PRR1-10.2196/55374 %M 38717812 %R 10.2196/55374 %U https://www.researchprotocols.org/2024/1/e55374 %U https://doi.org/10.2196/55374 %U http://www.ncbi.nlm.nih.gov/pubmed/38717812 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e46036 %T Effectiveness of an Artificial Intelligence-Assisted App for Improving Eating Behaviors: Mixed Methods Evaluation %A Chew,Han Shi Jocelyn %A Chew,Nicholas WS %A Loong,Shaun Seh Ern %A Lim,Su Lin %A Tam,Wai San Wilson %A Chin,Yip Han %A Chao,Ariana M %A Dimitriadis,Georgios K %A Gao,Yujia %A So,Jimmy Bok Yan %A Shabbir,Asim %A Ngiam,Kee Yuan %+ Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 3, Clinical Research Centre, Block MD11, 10 Medical Drive, Singapore, 117597, Singapore, 65 65168687, jocelyn.chew.hs@nus.edu.sg %K artificial intelligence %K chatbot %K chatbots %K weight %K overweight %K eating %K food %K weight loss %K mHealth %K mobile health %K app %K apps %K applications %K self-regulation %K self-monitoring %K anxiety %K depression %K consideration of future consequences %K mental health %K conversational agent %K conversational agents %K eating behavior %K healthy eating %K food consumption %K obese %K obesity %K diet %K dietary %D 2024 %7 7.5.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: A plethora of weight management apps are available, but many individuals, especially those living with overweight and obesity, still struggle to achieve adequate weight loss. An emerging area in weight management is the support for one’s self-regulation over momentary eating impulses. Objective: This study aims to examine the feasibility and effectiveness of a novel artificial intelligence–assisted weight management app in improving eating behaviors in a Southeast Asian cohort. Methods: A single-group pretest-posttest study was conducted. Participants completed the 1-week run-in period of a 12-week app-based weight management program called the Eating Trigger-Response Inhibition Program (eTRIP). This self-monitoring system was built upon 3 main components, namely, (1) chatbot-based check-ins on eating lapse triggers, (2) food-based computer vision image recognition (system built based on local food items), and (3) automated time-based nudges and meal stopwatch. At every mealtime, participants were prompted to take a picture of their food items, which were identified by a computer vision image recognition technology, thereby triggering a set of chatbot-initiated questions on eating triggers such as who the users were eating with. Paired 2-sided t tests were used to compare the differences in the psychobehavioral constructs before and after the 7-day program, including overeating habits, snacking habits, consideration of future consequences, self-regulation of eating behaviors, anxiety, depression, and physical activity. Qualitative feedback were analyzed by content analysis according to 4 steps, namely, decontextualization, recontextualization, categorization, and compilation. Results: The mean age, self-reported BMI, and waist circumference of the participants were 31.25 (SD 9.98) years, 28.86 (SD 7.02) kg/m2, and 92.60 (SD 18.24) cm, respectively. There were significant improvements in all the 7 psychobehavioral constructs, except for anxiety. After adjusting for multiple comparisons, statistically significant improvements were found for overeating habits (mean –0.32, SD 1.16; P<.001), snacking habits (mean –0.22, SD 1.12; P<.002), self-regulation of eating behavior (mean 0.08, SD 0.49; P=.007), depression (mean –0.12, SD 0.74; P=.007), and physical activity (mean 1288.60, SD 3055.20 metabolic equivalent task-min/day; P<.001). Forty-one participants reported skipping at least 1 meal (ie, breakfast, lunch, or dinner), summing to 578 (67.1%) of the 862 meals skipped. Of the 230 participants, 80 (34.8%) provided textual feedback that indicated satisfactory user experience with eTRIP. Four themes emerged, namely, (1) becoming more mindful of self-monitoring, (2) personalized reminders with prompts and chatbot, (3) food logging with image recognition, and (4) engaging with a simple, easy, and appealing user interface. The attrition rate was 8.4% (21/251). Conclusions: eTRIP is a feasible and effective weight management program to be tested in a larger population for its effectiveness and sustainability as a personalized weight management program for people with overweight and obesity. Trial Registration: ClinicalTrials.gov NCT04833803; https://classic.clinicaltrials.gov/ct2/show/NCT04833803 %M 38713909 %R 10.2196/46036 %U https://www.jmir.org/2024/1/e46036 %U https://doi.org/10.2196/46036 %U http://www.ncbi.nlm.nih.gov/pubmed/38713909 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55559 %T Development and Pilot-Testing of an Optimized Conversational Agent or “Chatbot” for Peruvian Adolescents Living With HIV to Facilitate Mental Health Screening, Education, Self-Help, and Linkage to Care: Protocol for a Mixed Methods, Community-Engaged Study %A Galea,Jerome T %A Vasquez,Diego H %A Rupani,Neil %A Gordon,Moya B %A Tapia,Milagros %A Greene,Karah Y %A Kolevic,Lenka %A Franke,Molly F %A Contreras,Carmen %+ School of Social Work, College of Behavioral and Community Sciences, University of South Florida, 13301 Bruce B Downs Boulevard, MHC 1400, Tampa, FL, 33612-3807, United States, 1 813 974 2310, jeromegalea@usf.edu %K chatbot %K digital assistant %K depression %K HIV %K adolescents %D 2024 %7 7.5.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adolescents living with HIV are disproportionally affected by depression, which worsens antiretroviral therapy adherence, increases viral load, and doubles the risk of mortality. Because most adolescents living with HIV live in low- and middle-income countries, few receive depression treatment due to a lack of mental health services and specialists in low-resource settings. Chatbot technology, used increasingly in health service delivery, is a promising approach for delivering low-intensity depression care to adolescents living with HIV in resource-constrained settings. Objective: The goal of this study is to develop and pilot-test for the feasibility and acceptability of a prototype, optimized conversational agent (chatbot) to provide mental health education, self-help skills, and care linkage for adolescents living with HIV. Methods: Chatbot development comprises 3 phases conducted over 2 years. In the first phase (year 1), formative research will be conducted to understand the views, opinions, and preferences of up to 48 youths aged 10-19 years (6 focus groups of up to 8 adolescents living with HIV per group), their caregivers (5 in-depth interviews), and HIV program personnel (5 in-depth interviews) regarding depression among adolescents living with HIV. We will also investigate the perceived acceptability of a mental health chatbot, including barriers and facilitators to accessing and using a chatbot for depression care by adolescents living with HIV. In the second phase (year 1), we will iteratively program a chatbot using the SmartBot360 software with successive versions (0.1, 0.2, and 0.3), meeting regularly with a Youth Advisory Board comprised of adolescents living with HIV who will guide and inform the chatbot development and content to arrive at a prototype version (version 1.0) for pilot-testing. In the third phase (year 2), we will pilot-test the prototype chatbot among 50 adolescents living with HIV naïve to its development. Participants will interact with the chatbot for up to 2 weeks, and data will be collected on the acceptability of the chatbot-delivered depression education and self-help strategies, depression knowledge changes, and intention to seek care linkage. Results: The study was awarded in April 2022, received institutional review board approval in November 2022, received funding in December 2022, and commenced recruitment in March 2023. By the completion of study phases 1 and 2, we expect our chatbot to incorporate key needs and preferences gathered from focus groups and interviews to develop the chatbot. By the completion of study phase 3, we will have assessed the feasibility and acceptability of the prototype chatbot. Study phase 3 began in April 2024. Final results are expected by January 2025 and published thereafter. Conclusions: The study will produce a prototype mental health chatbot developed with and for adolescents living with HIV that will be ready for efficacy testing in a subsequent, larger study. International Registered Report Identifier (IRRID): DERR1-10.2196/55559 %M 38713501 %R 10.2196/55559 %U https://www.researchprotocols.org/2024/1/e55559 %U https://doi.org/10.2196/55559 %U http://www.ncbi.nlm.nih.gov/pubmed/38713501 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e49519 %T Efficacy of the QuitSure App for Smoking Cessation in Adult Smokers: Cross-Sectional Web Survey %A Goldgof,Gregory M %A Mishra,Shweta %A Bajaj,Kriti %+ QuitSure, Rapidkart Online Private Limited, Bajaj Bhavan, 2nd Floor, 226 Nariman Point, Mumbai, 400021, India, 91 2222023626, kriti@quitsure.app %K smoking %K quit smoking %K smoking cessation %K smoking app %K QuitSure %K smoke free %K quit vaping %K vaping %K smoker %K smoke %K cross-sectional study %K smartphone app %K tobacco consumption %K tobacco %K survey %K nicotine %K nicotine withdrawal %K mobile phone %D 2024 %7 6.5.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Cigarette smoking remains one of the leading causes of preventable death worldwide. A worldwide study by the World Health Organization concluded that more than 8 million people die every year from smoking, tobacco consumption, and secondhand smoke. The most effective tobacco cessation programs require personalized human intervention combined with costly pharmaceutical supplementation, making them unaffordable or inaccessible to most tobacco users. Thus, digital interventions offer a promising alternative to these traditional methods. However, the leading smartphone apps available in the market today have either not been studied in a clinical setting or are unable to match the smoking cessation success rates of their expensive offline counterparts. We would like to understand whether QuitSure, a novel smoking cessation app built by Rapidkart Online Private Limited, is able to bridge this efficacy gap and deliver affordable and effective smoking cessation at scale. Objective: Our objective was to do an initial exploration into the engagement, efficacy, and safety of QuitSure based on the self-reported experiences of its users. Outcomes measured were program completion, the effect of program completion on smoking behavior, including self-reported cessation outcomes, and negative health events from using the app. Methods: All QuitSure registered users who created their accounts on the QuitSure app between April 1, 2021, and February 28, 2022, were sent an anonymized web-based survey. The survey results were added to their engagement data on the app to evaluate the feasibility and efficacy of the app as a smoking cessation intervention. The data were analyzed using descriptive statistics (frequencies and percentages) and the χ2 test of independence. Results: In total, 1299 users who had completed the QuitSure program submitted the survey and satisfied the inclusion criteria of the study. Of these, 1286 participants had completed the program more than 30 days before filling out the survey, and 1040 (80.1%, 95% CI 79.1%-82.6%) of them had maintained prolonged abstinence for at least 30 days after program completion. A majority of participants (770/891, 86.4%) who were still maintaining abstinence at the time of submitting the survey did not experience any severe nicotine withdrawal symptoms, while 41.9% (373/891) experienced no mild withdrawal symptoms either. Smoking quantity prior to completing the program significantly affected quit rates (P<.001), with heavy smokers (>20 cigarettes per day) having a lower 30-day prolonged abstinence rate (relative risk=0.91; 95% CI 90.0%-96.2%) compared to lighter smokers. No additional adverse events outside of known nicotine withdrawal symptoms were reported. Conclusions: The nature of web-based surveys and cohort selection allows for extensive unknown biases. However, the efficacy rates of survey respondents who completed the program were high and provide a case for further investigation in the form of randomized controlled trials on the QuitSure tobacco cessation program. %M 38709553 %R 10.2196/49519 %U https://humanfactors.jmir.org/2024/1/e49519 %U https://doi.org/10.2196/49519 %U http://www.ncbi.nlm.nih.gov/pubmed/38709553 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e52853 %T An mHealth Intervention for Gay and Bisexual Men’s Mental, Behavioral, and Sexual Health in a High-Stigma, Low-Resource Context (Project Comunică): Protocol for a Randomized Controlled Trial %A Leluțiu-Weinberger,Corina %A Filimon,Mircea L %A Hoover,Donald %A Lixandru,Mihai %A Hanu,Lucian %A Dogaru,Bogdan %A Kovacs,Tudor %A Fierbințeanu,Cristina %A Ionescu,Florentina %A Manu,Monica %A Mariș,Alexandra %A Pană,Elena %A Dorobănțescu,Cristian %A Streinu-Cercel,Adrian %A Pachankis,John E %+ School of Nursing, Columbia University, 560 West 168th Street, New York, NY, 10032, United States, 1 646 217 9205, cl4265@cumc.columbia.edu %K gay and bisexual men %K HIV prevention %K heavy alcohol use %K stigma %K mental health %K behavioral intervention %K mobile phone %D 2024 %7 6.5.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The World Health Organization reported that 80% of new HIV diagnoses in Europe in 2014 occurred in Central and Eastern Europe. Romania has a particularly high HIV incidence, AIDS prevalence, and number of related deaths. HIV incidence in Romania is largely attributed to sexual contact among gay and bisexual men. However, homophobic stigma in Romania serves as a risk factor for HIV infection for gay and bisexual men. The Comunică intervention aims to provide a much-needed HIV risk reduction strategy, and it entails the delivery of motivational interviewing and cognitive behavioral therapy skills across 8 live text-based counseling sessions on a mobile platform to gay and bisexual men at risk of HIV. The intervention is based on the information-motivation-behavior and minority stress models. There is preliminary evidence suggesting that Comunică holds promise for reducing gay and bisexual men’s co-occurring sexual (eg, HIV transmission risk behavior), behavioral (eg, heavy alcohol use), and mental (eg, depression) health risks in Romania. Objective: This paper describes the protocol for a randomized controlled trial designed to test the efficacy of Comunică in a national trial. Methods: To test Comunică’s efficacy, 305 gay and bisexual men were randomized to receive Comunică or a content-matched education attention control condition. The control condition consisted of 8 time-matched educational modules that present information regarding gay and bisexual men’s identity development, information about HIV transmission and prevention, the importance of HIV and sexually transmitted infection testing and treatment, heavy alcohol use and its associations with HIV transmission risk behavior, sexual health communication, finding social support, and creating sexual health goals. Participants undergo rapid HIV and syphilis testing and 3-site chlamydia and gonorrhea testing at baseline and the 12-month follow-up. Outcomes are measured before the intervention (baseline) and at the 4-, 8-, and 12-month follow-ups. Results: The study was funded in September 2018, and data collection began in May 2019. The last participant follow-up was in January 2024. Currently, the data analyst is cleaning data sets in preparation for data analyses, which are scheduled to begin in April 2024. Data analysis meetings are scheduled regularly to establish timelines and examine the results as analyses are gradually being conducted. Upon completion, a list of manuscripts will be reviewed and prioritized, and the team will begin preparing them for publication. Conclusions: This study is the first to test the efficacy of an intervention with the potential to simultaneously support the sexual, behavioral, and mental health of gay and bisexual men in Central and Eastern Europe using motivational interviewing support and sensitivity to the high-stigma context of the region. If efficacious, Comunică presents a scalable platform to provide support to gay and bisexual men living in Romania and similar high-stigma, low-resource countries. Trial Registration: ClinicalTrials.gov NCT03912753; https://clinicaltrials.gov/study/NCT03912753 International Registered Report Identifier (IRRID): DERR1-10.2196/52853 %M 38709550 %R 10.2196/52853 %U https://www.researchprotocols.org/2024/1/e52853 %U https://doi.org/10.2196/52853 %U http://www.ncbi.nlm.nih.gov/pubmed/38709550 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e53550 %T Integrating Virtual Mindfulness-Based Stress Reduction Into Inflammatory Bowel Disease Care: Mixed Methods Feasibility Trial %A Chappell,Kaitlyn Delaney %A Meakins,Diana %A Marsh-Joyal,Melanie %A Bihari,Allison %A Goodman,Karen J %A Le Melledo,Jean-Michel %A Lim,Allen %A Peerani,Farhad %A Kroeker,Karen Ivy %+ Division of Gastroenterology, Department of Medicine, University of Alberta, 130 University Campus NW, Edmonton, AB, T6G 2X8, Canada, 1 780 492 4873, karen.kroeker@ualberta.ca %K inflammatory bowel disease %K psychosocial care %K multidisciplinary care %K quality of care %K quality of life %K mental health %K adult %K adults %K anxiety %K depression %K IBD %K virtual mindfulness %K feasibility trial %K clinic %K health facility %K Canada %K semistructured interview %K psychiatrist %K psychiatrists %K videoconferencing %K effectiveness %K v-MBSR %K coping %K coping strategy %D 2024 %7 6.5.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Individuals with inflammatory bowel disease (IBD) experience cycles of aggressive physical symptoms including abdominal pain, diarrhea, and fatigue. These acute symptoms regress and return, and chronic symptoms and complications often linger. The nature of the disease can also cause individuals to experience psychological distress including symptoms of anxiety and depression; however, unlike the physical symptoms of IBD, these psychological symptoms often remain untreated. Objective: This study aims to evaluate the feasibility, acceptability, and effectiveness of virtual mindfulness-based stress reduction (v-MBSR) for adults with IBD. Methods: IBD patients with self-reported anxiety or depression were recruited from clinics in Alberta, Canada to participate in an 8-week v-MSBR intervention. Eligible patients participated in v-MBSR delivered by psychiatrists using a videoconferencing platform. Primary feasibility outcomes included trial uptake, adherence, attendance, and attrition rates. Secondary effectiveness outcomes included measures of anxiety, depression, quality of life (QoL), and mindfulness. Effectiveness data were collected at 3 time points: baseline, at intervention completion, and 6 months after completion. To further assess feasibility and acceptability, participants were invited to participate in a semistructured interview after completing v-MBSR. Results: A total of 16 of the 64 (25%) referred patients agreed to participate in v-MBSR with the most common reason for decline being a lack of time while 7 of the 16 (43.8%) participants completed the program and experienced encouraging effects including decreased anxiety and depression symptoms and increased health-related QoL with both improvements persisting at 6-month follow-up. Participants described improved coping strategies and disease management techniques as benefits of v-MBSR. Conclusions: Patients with IBD were interested in a psychiatrist-led virtual anxiety management intervention, but results demonstrate v-MBSR may be too time intensive for some patients with IBD patients. v-MBSR was acceptable to those who completed the intervention, and improvements to anxiety, depression, and QoL were promising and sustainable. Future studies should attempt to characterize the patients with IBD who may benefit most from interventions like v-MBSR. %M 38709548 %R 10.2196/53550 %U https://formative.jmir.org/2024/1/e53550 %U https://doi.org/10.2196/53550 %U http://www.ncbi.nlm.nih.gov/pubmed/38709548 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e50747 %T Assessing the Feasibility and Preliminary Effects of a Web-Based Self-Management Program for Chronic Noncancer Pain: Mixed Methods Study %A Marier-Deschenes,Pascale %A Pinard,Anne Marie %A Jalbert,Laura %A LeBlanc,Annie %+ CIRRIS, Centre interdisciplinaire de recherche en réadaptation et intégration sociale, 525, boul. Wilfrid-Hamel Québec, Québec, QC, G1M 2S8, Canada, 1 418 649 3735, pascale.marier-deschenes.1@ulaval.ca %K persistent pain %K eHealth %K self-paced intervention %K web-based program %K evidence based %K web based %K self-management %K pain %K chronic pain %K mixed methods study %K pain treatment %K pain education %D 2024 %7 3.5.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: In Canada, adults with chronic noncancer pain face a persistent insufficiency of publicly funded resources, with the gold standard multidisciplinary pain treatment facilities unable to meet the high clinical demand. Web-based self-management programs cost-effectively increase access to pain management and can improve several aspects of physical and emotional functioning. Aiming to meet the demand for accessible, fully automated resources for individuals with chronic noncancer pain, we developed a French web- and evidence-based self-management program, Agir pour moi (APM). This program includes pain education and strategies to reduce stress, practice mindfulness, apply pacing, engage in physical activity, identify and manage thinking traps, sleep better, adapt diet, and sustain behavior change. Objective: This study aims to assess the APM self-management program’s feasibility, acceptability, and preliminary effects in adults awaiting specialized services from a center of expertise in chronic pain management. Methods: We conducted a mixed methods study with an explanatory sequential design, including a web-based 1-arm trial and qualitative semistructured interviews. We present the results from both phases through integrative tables called joint displays. Results: Response rates were 70% (44/63) at postintervention and 56% (35/63) at 3-month follow-up among the 63 consenting participants who provided self-assessed information at baseline. In total, 46% (29/63) of the participants completed the program. We interviewed 24% (15/63) of the participants. The interview’s first theme revolved around the overall acceptance, user-friendliness, and engaging nature of the program. The second theme emphasized the differentiation between microlevel and macrolevel engagements. The third theme delved into the diverse effects observed, potentially influenced by the macrolevel engagements. Participants highlighted the features that impacted their self-efficacy and the adoption of self-management strategies. We observed indications of improvement in self-efficacy, pain intensity, pain interference, depression, and catastrophizing. Interviewees described these and various other effects as potentially influenced by macrolevel engagement through behavioral change. Conclusions: These findings provided preliminary evidence that the APM self-management program and research methods are feasible. However, some participants expressed the need for at least phone reminders and minimal support from a professional available to answer questions over the first few weeks of the program to engage. Recruitment strategies of a future randomized controlled trial should focus on attracting a broader representation of individuals with chronic pain in terms of gender and ethnicity. Trial Registration: ClinicalTrials.gov NCT05319652; https://clinicaltrials.gov/study/NCT05319652 %M 38701440 %R 10.2196/50747 %U https://humanfactors.jmir.org/2024/1/e50747 %U https://doi.org/10.2196/50747 %U http://www.ncbi.nlm.nih.gov/pubmed/38701440 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e52145 %T A Factorial Randomized Controlled Trial to Optimize User Engagement With a Chatbot-Led Parenting Intervention: Protocol for the ParentText Optimisation Trial %A Ambrosio,Maria Da Graca %A Lachman,Jamie M %A Zinzer,Paula %A Gwebu,Hlengiwe %A Vyas,Seema %A Vallance,Inge %A Calderon,Francisco %A Gardner,Frances %A Markle,Laurie %A Stern,David %A Facciola,Chiara %A Schley,Anne %A Danisa,Nompumelelo %A Brukwe,Kanyisile %A Melendez-Torres,GJ %+ University of Oxford, Barnett House, 32-37 Wellington Square, Oxford, OX1 2ER, United Kingdom, 44 (0)1865270325, maria.ambrosio@wolfson.ox.ac.uk %K parenting intervention %K chatbot-led public health intervention %K engagement %K implementation science %K mobile phone %D 2024 %7 3.5.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Violence against children (VAC) is a serious public health concern with long-lasting adverse effects. Evidence-based parenting programs are one effective means to prevent VAC; however, these interventions are not scalable in their typical in-person group format, especially in low- and middle-income countries where the need is greatest. While digital delivery, including via chatbots, offers a scalable and cost-effective means to scale up parenting programs within these settings, it is crucial to understand the key pillars of user engagement to ensure their effective implementation. Objective: This study aims to investigate the most effective and cost-effective combination of external components to optimize user engagement with ParentText, an open-source chatbot-led parenting intervention to prevent VAC in Mpumalanga, South Africa. Methods: This study will use a mixed methods design incorporating a 2 × 2 factorial cluster-randomized controlled trial and qualitative interviews. Parents of adolescent girls (32 clusters, 120 participants [60 parents and 60 girls aged 10 to 17 years] per cluster; N=3840 total participants) will be recruited from the Ehlanzeni and Nkangala districts of Mpumalanga. Clusters will be randomly assigned to receive 1 of the 4 engagement packages that include ParentText alone or combined with in-person sessions and a facilitated WhatsApp support group. Quantitative data collected will include pretest-posttest parent- and adolescent-reported surveys, facilitator-reported implementation data, and digitally tracked engagement data. Qualitative data will be collected from parents and facilitators through in-person or over-the-phone individual semistructured interviews and used to expand the interpretation and understanding of the quantitative findings. Results: Recruitment and data collection started in August 2023 and were finalized in November 2023. The total number of participants enrolled in the study is 1009, with 744 caregivers having completed onboarding to the chatbot-led intervention. Female participants represent 92.96% (938/1009) of the sample population, whereas male participants represent 7.03% (71/1009). The average participant age is 43 (SD 9) years. Conclusions: The ParentText Optimisation Trial is the first study to rigorously test engagement with a chatbot-led parenting intervention in a low- or middle-income country. The results of this study will inform the final selection of external delivery components to support engagement with ParentText in preparation for further evaluation in a randomized controlled trial in 2024. Trial Registration: Open Science Framework (OSF); https://doi.org/10.17605/OSF.IO/WFXNE International Registered Report Identifier (IRRID): DERR1-10.2196/52145 %M 38700935 %R 10.2196/52145 %U https://www.researchprotocols.org/2024/1/e52145 %U https://doi.org/10.2196/52145 %U http://www.ncbi.nlm.nih.gov/pubmed/38700935 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55156 %T KIJANI App to Promote Physical Activity in Children and Adolescents: Protocol for a Mixed Method Evaluation %A Willinger,Laura %A Böhm,Birgit %A Schweizer,Florian %A Reimer,Lara Marie %A Jonas,Stephan %A Scheller,Daniel A %A Oberhoffer-Fritz,Renate %A Müller,Jan %+ Chair of Preventive Pediatrics, Technical University of Munich, Georg-Brauchle-Ring 60/62, 80992 München, Munich, Germany, 49 28924900, laura.willinger@tum.de %K physical activity %K health promotion %K digital health %K gamification %K childhood %K adolescence %K adolescents %K adolescent %K children %K augmented reality %K KIJANI intervention %K KIJANI %K intervention %K user experience %D 2024 %7 3.5.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The prevalence of physical inactivity among children and adolescents is alarmingly high despite the well-documented and comprehensive benefits of regular physical activity (PA). Therefore, PA promotion should start early in childhood and adolescence. Although reducing recreational screen time in children and adolescents is an urgent concern, digital approaches have the potential to make activity promotion attractive and age appropriate for the target group. KIJANI is a mobile app approach to promote PA in children and adolescents via gamification and augmented reality. Objective: This study protocol aims to describe the KIJANI intervention in detail, as well as the evaluation approach. Methods: KIJANI is based on the concept that virtual coins can be earned through PA, for example, in the form of a collected step count. With these coins, in turn, blocks can be bought, which can be used to create virtual buildings and integrate them into the player’s real-world environment via augmented reality. PA of users is detected via accelerometers integrated into the smartphones. KIJANI can be played at predefined play locations that were comprehensively identified as safe, child-friendly, and attractive for PA by the target group in a partner project. The evaluation process will be divided into 2 different stages. The phase-I evaluation will be a mixed methods approach with one-on-one semistructured interviews and questionnaires to evaluate the user experience and receive feedback from the target group. After the implementation of results and feedback from the target group, the phase-II evaluation will proceed in the form of a 2-arm randomized controlled trial, in which the effectiveness of KIJANI will be assessed via objectively measured PA as well as questionnaires. Results: The study received ethical approval from the ethical board of the Technical University of Munich. Participants for the phase-I evaluation are currently being recruited. Conclusions: The study will help to determine the efficacy, applicability, and user experience of a gamified activity promotion application in children and adolescents. Overall, digital health approaches provide easy and wide reachability at low cost and are age appropriate and attractive for the target group of adolescents. Strategies have to be developed to apply digital health approaches in the best possible way for activity promotion. International Registered Report Identifier (IRRID): DERR1-10.2196/55156 %M 38700911 %R 10.2196/55156 %U https://www.researchprotocols.org/2024/1/e55156 %U https://doi.org/10.2196/55156 %U http://www.ncbi.nlm.nih.gov/pubmed/38700911 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e54124 %T Efficacy of the Flo App in Improving Health Literacy, Menstrual and General Health, and Well-Being in Women: Pilot Randomized Controlled Trial %A Cunningham,Adam C %A Prentice,Carley %A Peven,Kimberly %A Wickham,Aidan %A Bamford,Ryan %A Radovic,Tara %A Klepchukova,Anna %A Fomina,Maria %A Cunningham,Katja %A Hill,Sarah %A Hantsoo,Liisa %A Payne,Jennifer %A Zhaunova,Liudmila %A Ponzo,Sonia %+ Flo Health UK Limited, 27 Old Gloucester Street, London, WC1N 3AX, United Kingdom, 44 7770032146, l_zhaunova@flo.health %K digital health %K health literacy %K menstrual cycle %K period tracking app %K women’s health %K PMS %K PMDD %K tracking %K app %K application %K tracking app %K tracking application %K menstrual %K women %K efficacy %K general health %K wellbeing %K randomized controlled trial %K awareness %K symptoms %K manage %K management %K premenstrual %K premenstrual syndrome %K premenstrual dysphoric disorder %K reproductive %K reproductive health %K health management %K communication %K pregnancy %K quality of life %K productivity %K education %K functionality %D 2024 %7 2.5.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Reproductive health literacy and menstrual health awareness play a crucial role in ensuring the health and well-being of women and people who menstruate. Further, awareness of one’s own menstrual cycle patterns and associated symptoms can help individuals identify and manage conditions of the menstrual cycle such as premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD). Digital health products, and specifically menstrual health apps, have the potential to effect positive change due to their scalability and ease of access. Objective: The primary aim of this study was to measure the efficacy of a menstrual and reproductive health app, Flo, in improving health literacy and health and well-being outcomes in menstruating individuals with and without PMS and PMDD. Further, we explored the possibility that the use of the Flo app could positively influence feelings around reproductive health management and communication about health, menstrual cycle stigma, unplanned pregnancies, quality of life, work productivity, absenteeism, and body image. Methods: We conducted 2 pilot, 3-month, unblinded, 2-armed, remote randomized controlled trials on the effects of using the Flo app in a sample of US-based (1) individuals who track their cycles (n=321) or (2) individuals who track their cycles and are affected by PMS or PMDD (n=117). Results: The findings revealed significant improvements at the end of the study period compared to baseline for our primary outcomes of health literacy (cycle tracking: D̄=1.11; t311=5.73, P<.001; PMS or PMDD: D̄=1.20; t115=3.76, P<.001) and menstrual health awareness (D̄=3.97; t311=7.71, P<.001), health and well-being (D̄=3.44; t311=5.94, P<.001), and PMS or PMDD symptoms burden (D̄=–7.08; t115=–5.44, P<.001). Improvements were also observed for our secondary outcomes of feelings of control and management over health (D̄=1.01; t311=5.08, P<.001), communication about health (D̄=0.93; t311=2.41, P=.002), menstrual cycle stigma (D̄=–0.61; t311=–2.73, P=.007), and fear of unplanned pregnancies (D̄=–0.22; t311=–2.11, P=.04) for those who track their cycles, as well as absenteeism from work and education due to PMS or PMDD (D̄=–1.67; t144=–2.49, P=.01). Conclusions: These pilot randomized controlled trials demonstrate that the use of the Flo app improves menstrual health literacy and awareness, general health and well-being, and PMS or PMDD symptom burden. Considering the widespread use and affordability of the Flo app, these findings show promise for filling important gaps in current health care provisioning such as improving menstrual knowledge and health. Trial Registration: OSF Registries osf.io/pcgw7; https://osf.io/pcgw7 ; OSF Registries osf.io/ry8vq; https://osf.io/ry8vq %M 38696773 %R 10.2196/54124 %U https://mhealth.jmir.org/2024/1/e54124 %U https://doi.org/10.2196/54124 %U http://www.ncbi.nlm.nih.gov/pubmed/38696773 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e50385 %T An Exploration of the Goodness of Fit of Web-Based Tools for Māori: Qualitative Study Using Interviews and Focus Groups %A Donkin,Liesje %A Bidois-Putt,Marie-Claire %A Wilson,Holly %A Hayward,Penelope %A Chan,Amy Hai Yan %+ Department of Psychology and Neuroscience, Auckland University of Technology, Akoranga Drive, Northcote, Auckland, 0627, New Zealand, 64 21847886, liesje.donkin@aut.ac.nz %K Indigenous people %K Māori %K eHealth %K mental health %K web-based intervention %K digital intervention %D 2024 %7 2.5.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Indigenous communities often have poorer health outcomes and services under traditional models of care. In New Zealand, this holds true for Māori people who are tāngata whenua (the indigenous people). Several barriers exist that decrease the likelihood of indigenous communities often have poorer health outcomes and poor service fit under traditional models of care, including access issues, systemic and provider racism, and a lack of culturally safe and responsive services. Web-based interventions (WBIs) have been shown to be effective in supporting mental health and well-being and can overcome some of these barriers. Despite the large number of WBIs developed, more investigation is needed to know how well WBIs fit with an indigenous worldview and how they meet the needs of indigenous communities so that a digitally based future does not drive social and health inequities. Objective: This study aims to explore the goodness-of-fit of WBIs of Māori individuals, the indigenous people of Aotearoa/New Zealand. Methods: We used interviews (n=3) and focus groups (n=5) with 30 Māori participants to explore their views about WBIs. Interviews were analyzed using reflexive thematic analysis by members of the research team. Results: Overall, there was a perception that the design of WBIs did not align with the Māori worldview, which centers around people, relationships, spirituality, and holistic views of well-being. A total of 4 key themes and several subthemes emerged, indicating that WBIs were generally considered a poor fit for Māori. Specifically, the themes were as follows: (1) WBIs are disconnected from the core values of te ao Māori (the Māori worldview), (2) WBIs could be helpful in the right context, (3) there are significant barriers that may make it harder for Māori to use WBIs than other groups, and (4) ways to improve WBIs to help engagement with Māori. Conclusions: While WBIs are often considered a way to reduce barriers to care, they may not meet the needs of Māori when used as a stand-alone intervention. If WBIs are continued to be offered, developers and researchers need to consider how to develop WBIs that are responsive and engaging to the needs of indigenous communities rather than driving inequities. Ideally, WBIs should be developed by the people they are intended for to fit with those populations’ world views. %M 38696236 %R 10.2196/50385 %U https://formative.jmir.org/2024/1/e50385 %U https://doi.org/10.2196/50385 %U http://www.ncbi.nlm.nih.gov/pubmed/38696236 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e50922 %T Digital Intervention (Keep-On-Keep-Up Nutrition) to Improve Nutrition in Older Adults: Protocol for a Feasibility Randomized Controlled Trial %A French,Chloe %A Burden,Sorrel %A Stanmore,Emma %+ School of Health Sciences, University of Manchester, 176 Oxford Road, Manchester, M13 9PL, United Kingdom, 44 01613067856, emma.stanmore@manchester.ac.uk %K feasibility %K usability %K digital health %K diet %K gerontology %K geriatric %K geriatrics %K older adult %K older adults %K elder %K elderly %K older person %K older people %K ageing %K aging %K dietary %K nutrition %K hydration %K community dwelling %K RCT %K randomized %K controlled trial %K controlled trials %D 2024 %7 30.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Digital health tools can support behavior change and allow interventions to be scalable at a minimal cost. Keep-on-Keep-up Nutrition (KOKU-Nut) is a free, tablet-based app that focuses on increasing physical activity and improving the dietary intake of older adults based on UK guidelines. The intervention targets an important research area identified as a research priority reported by the James Lind Alliance priority setting partnership for malnutrition. Objective: This study aims to assess the feasibility of using the digital health tool KOKU-Nut among community-dwelling older adults to inform a future randomized controlled trial. The secondary aims are to determine the acceptability, usability, preliminary effect sizes, and safety of the study and the intervention (KOKU-Nut). Methods: This is a feasibility randomized controlled trial. We plan to recruit a total of 36 community-dwelling older adults using purposive sampling. Participants will be randomized 1:1 to either the intervention or the control group. The intervention group will be asked to engage with KOKU-Nut 3 times a week for 12 weeks. Participants in the control group will receive a leaflet promoting a healthy lifestyle. All study participants will complete questionnaires at baseline and the end of the 12 weeks. A sample of participants will be asked to participate in an optional interview. The study will collect a range of data including anthropometry (height and weight), dietary intake (3-day food diary), physical function (grip strength and 5-times sit-to-stand), perceived quality of life (EQ-5D), usability (System Usability Scale), and safety (adverse events). Results: Data collection commenced in March 2024, and the results will be ready for publication by January 2025. Feasibility will be determined on the basis of participants’ self-reported engagement with the intervention, and recruitment and retention rates and will be summarized descriptively. We will also consider the amount of missing data and assess how outcomes are related to group assignment. Acceptability will be measured using the modified treatment evaluation inventory and one-to-one semistructured interviews. Transcripts from the interviews will be analyzed using NVivo (version 12; QSR International) software using framework analysis to understand any barriers to the recruitment process, the suitability of the assessment measures, and the acceptability of the intervention and study design. Conclusions: The study aligns with guidelines developed by the Medical Research Council for developing a complex intervention by using qualitative and quantitative research to examine the barriers of the intervention and identify potential challenges around recruitment and retention. We anticipate that these results will inform the development of a future powered randomized controlled design trial to test the true effectiveness of KOKU-Nut. Trial Registration: ClinicalTrials.gov NCT05943366; https://classic.clinicaltrials.gov/ct2/show/NCT05943366 International Registered Report Identifier (IRRID): PRR1-10.2196/50922 %M 38687981 %R 10.2196/50922 %U https://www.researchprotocols.org/2024/1/e50922 %U https://doi.org/10.2196/50922 %U http://www.ncbi.nlm.nih.gov/pubmed/38687981 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e51478 %T Effectiveness of mHealth App–Based Interventions for Increasing Physical Activity and Improving Physical Fitness in Children and Adolescents: Systematic Review and Meta-Analysis %A Wang,Jun-Wei %A Zhu,Zhicheng %A Shuling,Zhang %A Fan,Jia %A Jin,Yu %A Gao,Zhan-Le %A Chen,Wan-Di %A Li,Xue %+ School of Sport Medicine and Health, Chengdu Sport University, No.2, Tiyuan Road, Wuhou District, Chengdu, 610041, China, 86 13550146822, lixue2078@126.com %K mobile health %K mHealth apps %K children and adolescents %K physical activity %K physical fitness %K systematic review %K meta-analysis %K mobile phone %D 2024 %7 30.4.2024 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: The COVID-19 pandemic has significantly reduced physical activity (PA) levels and increased sedentary behavior (SB), which can lead to worsening physical fitness (PF). Children and adolescents may benefit from mobile health (mHealth) apps to increase PA and improve PF. However, the effectiveness of mHealth app–based interventions and potential moderators in this population are not yet fully understood. Objective: This study aims to review and analyze the effectiveness of mHealth app–based interventions in promoting PA and improving PF and identify potential moderators of the efficacy of mHealth app–based interventions in children and adolescents. Methods: We searched for randomized controlled trials (RCTs) published in the PubMed, Web of Science, EBSCO, and Cochrane Library databases until December 25, 2023, to conduct this meta-analysis. We included articles with intervention groups that investigated the effects of mHealth-based apps on PA and PF among children and adolescents. Due to high heterogeneity, a meta-analysis was conducted using a random effects model. The Cochrane Risk of Bias Assessment Tool was used to evaluate the risk of bias. Subgroup analysis and meta-regression analyses were performed to identify potential influences impacting effect sizes. Results: We included 28 RCTs with a total of 5643 participants. In general, the risk of bias of included studies was low. Our findings showed that mHealth app–based interventions significantly increased total PA (TPA; standardized mean difference [SMD] 0.29, 95% CI 0.13-0.45; P<.001), reduced SB (SMD –0.97, 95% CI –1.67 to –0.28; P=.006) and BMI (weighted mean difference –0.31 kg/m2, 95% CI –0.60 to –0.01 kg/m2; P=.12), and improved muscle strength (SMD 1.97, 95% CI 0.09-3.86; P=.04) and agility (SMD –0.35, 95% CI –0.61 to –0.10; P=.006). However, mHealth app–based interventions insignificantly affected moderate to vigorous PA (MVPA; SMD 0.11, 95% CI –0.04 to 0.25; P<.001), waist circumference (weighted mean difference 0.38 cm, 95% CI –1.28 to 2.04 cm; P=.65), muscular power (SMD 0.01, 95% CI –0.08 to 0.10; P=.81), cardiorespiratory fitness (SMD –0.20, 95% CI –0.45 to 0.05; P=.11), muscular endurance (SMD 0.47, 95% CI –0.08 to 1.02; P=.10), and flexibility (SMD 0.09, 95% CI –0.23 to 0.41; P=.58). Subgroup analyses and meta-regression showed that intervention duration was associated with TPA and MVPA, and age and types of intervention was associated with BMI. Conclusions: Our meta-analysis suggests that mHealth app–based interventions may yield small-to-large beneficial effects on TPA, SB, BMI, agility, and muscle strength in children and adolescents. Furthermore, age and intervention duration may correlate with the higher effectiveness of mHealth app–based interventions. However, due to the limited number and quality of included studies, the aforementioned conclusions require validation through additional high-quality research. Trial Registration: PROSPERO CRD42023426532; https://tinyurl.com/25jm4kmf %M 38687568 %R 10.2196/51478 %U https://mhealth.jmir.org/2024/1/e51478 %U https://doi.org/10.2196/51478 %U http://www.ncbi.nlm.nih.gov/pubmed/38687568 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 10 %N %P e49002 %T Implementation of Health IT for Cancer Screening in US Primary Care: Scoping Review %A Owens-Jasey,Constance %A Chen,Jinying %A Xu,Ran %A Angier,Heather %A Huebschmann,Amy G %A Ito Fukunaga,Mayuko %A Chaiyachati,Krisda H %A Rendle,Katharine A %A Robien,Kim %A DiMartino,Lisa %A Amante,Daniel J %A Faro,Jamie M %A Kepper,Maura M %A Ramsey,Alex T %A Bressman,Eric %A Gold,Rachel %+ OCHIN, Inc, PO Box 5426, Portland, OR, 97228-5426, United States, 1 503 943 2500, owensc@ochin.org %K cancer prevention %K health information technology %K implementation %K implementation strategies %K scoping review %D 2024 %7 30.4.2024 %9 Review %J JMIR Cancer %G English %X Background: A substantial percentage of the US population is not up to date on guideline-recommended cancer screenings. Identifying interventions that effectively improve screening rates would enhance the delivery of such screening. Interventions involving health IT (HIT) show promise, but much remains unknown about how HIT is optimized to support cancer screening in primary care. Objective: This scoping review aims to identify (1) HIT-based interventions that effectively support guideline concordance in breast, cervical, and colorectal cancer screening provision and follow-up in the primary care setting and (2) barriers or facilitators to the implementation of effective HIT in this setting. Methods: Following scoping review guidelines, we searched MEDLINE, CINAHL Plus, Web of Science, and IEEE Xplore databases for US-based studies from 2015 to 2021 that featured HIT targeting breast, colorectal, and cervical cancer screening in primary care. Studies were dual screened using a review criteria checklist. Data extraction was guided by the following implementation science frameworks: the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework; the Expert Recommendations for Implementing Change taxonomy; and implementation strategy reporting domains. It was also guided by the Integrated Technology Implementation Model that incorporates theories of both implementation science and technology adoption. Reporting was guided by PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews). Results: A total of 101 studies met the inclusion criteria. Most studies (85/101, 84.2%) involved electronic health record–based HIT interventions. The most common HIT function was clinical decision support, primarily used for panel management or at the point of care. Most studies related to HIT targeting colorectal cancer screening (83/101, 82.2%), followed by studies related to breast cancer screening (28/101, 27.7%), and cervical cancer screening (19/101, 18.8%). Improvements in cancer screening were associated with HIT-based interventions in most studies (36/54, 67% of colorectal cancer–relevant studies; 9/14, 64% of breast cancer–relevant studies; and 7/10, 70% of cervical cancer–relevant studies). Most studies (79/101, 78.2%) reported on the reach of certain interventions, while 17.8% (18/101) of the included studies reported on the adoption or maintenance. Reported barriers and facilitators to HIT adoption primarily related to inner context factors of primary care settings (eg, staffing and organizational policies that support or hinder HIT adoption). Implementation strategies for HIT adoption were reported in 23.8% (24/101) of the included studies. Conclusions: There are substantial evidence gaps regarding the effectiveness of HIT-based interventions, especially those targeting guideline-concordant breast and colorectal cancer screening in primary care. Even less is known about how to enhance the adoption of technologies that have been proven effective in supporting breast, colorectal, or cervical cancer screening. Research is needed to ensure that the potential benefits of effective HIT-based interventions equitably reach diverse primary care populations. %M 38687595 %R 10.2196/49002 %U https://cancer.jmir.org/2024/1/e49002 %U https://doi.org/10.2196/49002 %U http://www.ncbi.nlm.nih.gov/pubmed/38687595 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e50855 %T Digital Self-Management Platform for Adult Asthma: Randomized Attention-Placebo Controlled Trial %A Kandola,Aaron %A Edwards,Kyra %A Straatman,Joris %A Dührkoop,Bettina %A Hein,Bettina %A Hayes,Joseph %+ Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7BN, United Kingdom, 44 2089288300, joseph.hayes@ucl.ac.uk %K asthma %K mobile health %K self-management %K randomized controlled trial %K randomized %K controlled trial %K controlled trials %K RCT %K RCTs %K respiratory %K pulmonary %K smartphone %K platform %K digital health %K chronic %K breathing %K disease management %K mHealth %K mobile health %K app %K apps %K application %K applications %K mobile phone %D 2024 %7 29.4.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Asthma is one of the most common chronic conditions worldwide, with a substantial individual and health care burden. Digital apps hold promise as a highly accessible, low-cost method of enhancing self-management in asthma, which is critical to effective asthma control. Objective: We conducted a fully remote randomized controlled trial (RCT) to assess the efficacy of juli, a commercially available smartphone self-management platform for asthma. Methods: We conducted a pragmatic single-blind, RCT of juli for asthma management. Our study included participants aged 18 years and older who self-identified as having asthma and had an Asthma Control Test (ACT) score of 19 or lower (indicating uncontrolled asthma) at the beginning of the trial. Participants were randomized (1:1 ratio) to receive juli for 8 weeks or a limited attention-placebo control version of the app. The primary outcome measure was the difference in ACT scores after 8 weeks. Secondary outcomes included remission (ACT score greater than 19), minimal clinically important difference (an improvement of 3 or more points on the ACT), worsening of asthma, and health-related quality of life. The primary analysis included participants using the app for 8 weeks (per-protocol analysis), and the secondary analysis used a modified intention-to-treat (ITT) analysis. Results: We randomized 411 participants between May 2021 and April 2023: a total of 152 (37%) participants engaged with the app for 8 weeks and were included in the per-protocol analysis, and 262 (63.7%) participants completed the week-2 outcome assessment and were included in the modified ITT analysis. Total attrition between baseline and week 8 was 259 (63%) individuals. In the per-protocol analysis, the intervention group had a higher mean ACT score (17.93, SD 4.72) than the control group (16.24, SD 5.78) by week 8 (baseline adjusted coefficient 1.91, 95% CI 0.31-3.51; P=.02). Participants using juli had greater odds of achieving or exceeding the minimal clinically important difference at 8 weeks (adjusted odds ratio 2.38, 95% CI 1.20-4.70; P=.01). There were no between group differences in the other secondary outcomes at 8 weeks. The results from the modified ITT analyses were similar. Conclusions: Users of juli had improved asthma symptom control over 8 weeks compared with users of a version of the app with limited functionality. These findings suggest that juli is an effective digital self-management platform that could augment existing care pathways for asthma. The retention of patients in RCTs and real-world use of digital health care apps is a major challenge. Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN) registry ISRCTN87679686; https://www.isrctn.com/ISRCTN87679686 %M 38684084 %R 10.2196/50855 %U https://www.jmir.org/2024/1/e50855 %U https://doi.org/10.2196/50855 %U http://www.ncbi.nlm.nih.gov/pubmed/38684084 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e52075 %T Effectiveness of a Smartphone App–Based Intervention With Bluetooth-Connected Monitoring Devices and a Feedback System in Heart Failure (SMART-HF Trial): Randomized Controlled Trial %A Yoon,Minjae %A Lee,Seonhwa %A Choi,Jah Yeon %A Jung,Mi-Hyang %A Youn,Jong-Chan %A Shim,Chi Young %A Choi,Jin-Oh %A Kim,Eung Ju %A Kim,Hyungseop %A Yoo,Byung-Su %A Son,Yeon Joo %A Choi,Dong-Ju %+ Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seognam, 13620, Republic of Korea, 82 317877007, djchoi@snubh.org %K heart failure %K mobile applications %K mobile health %K self-care %K vital sign monitoring %K mobile phone %D 2024 %7 29.4.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Current heart failure (HF) guidelines recommend a multidisciplinary approach, discharge education, and self-management for HF. However, the recommendations are challenging to implement in real-world clinical settings. Objective: We developed a mobile health (mHealth) platform for HF self-care to evaluate whether a smartphone app–based intervention with Bluetooth-connected monitoring devices and a feedback system can help improve HF symptoms. Methods: In this prospective, randomized, multicenter study, we enrolled patients 20 years of age and older, hospitalized for acute HF, and who could use a smartphone from 7 tertiary hospitals in South Korea. In the intervention group (n=39), the apps were automatically paired with Bluetooth-connected monitoring devices. The patients could enter information on vital signs, HF symptoms, diet, medications, and exercise regimen into the app daily and receive feedback or alerts on their input. In the control group (n=38), patients could only enter their blood pressure, heart rate, and weight using conventional, non-Bluetooth devices and could not receive any feedback or alerts from the app. The primary end point was the change in dyspnea symptom scores from baseline to 4 weeks, assessed using a questionnaire. Results: At 4 weeks, the change in dyspnea symptom score from baseline was significantly greater in the intervention group than in the control group (mean –1.3, SD 2.1 vs mean –0.3, SD 2.3; P=.048). A significant reduction was found in body water composition from baseline to the final measurement in the intervention group (baseline level mean 7.4, SD 2.5 vs final level mean 6.6, SD 2.5; P=.003). App adherence, which was assessed based on log-in or the percentage of days when symptoms were first observed, was higher in the intervention group than in the control group. Composite end points, including death, rehospitalization, and urgent HF visits, were not significantly different between the 2 groups. Conclusions: The mobile-based health platform with Bluetooth-connected monitoring devices and a feedback system demonstrated improvement in dyspnea symptoms in patients with HF. This study provides evidence and rationale for implementing mobile app–based self-care strategies and feedback for patients with HF. Trial Registration: ClinicalTrials.gov NCT05668000; https://clinicaltrials.gov/study/NCT05668000 %M 38683665 %R 10.2196/52075 %U https://www.jmir.org/2024/1/e52075 %U https://doi.org/10.2196/52075 %U http://www.ncbi.nlm.nih.gov/pubmed/38683665 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e54581 %T Usability Comparison Among Healthy Participants of an Anthropomorphic Digital Human and a Text-Based Chatbot as a Responder to Questions on Mental Health: Randomized Controlled Trial %A Thunström,Almira Osmanovic %A Carlsen,Hanne Krage %A Ali,Lilas %A Larson,Tomas %A Hellström,Andreas %A Steingrimsson,Steinn %+ Region Västra Götaland, Psychiatric Department, Sahlgrenska University Hospital, Journalvägen 5, Gothenburg, 41650, Sweden, 46 313421000, steinn.steingrimsson@gu.se %K chatbot %K chatbots %K chat-bot %K chat-bots %K text-only chatbot, voice-only chatbot %K mental health %K mental illness %K mental disease %K mental diseases %K mental illnesses %K mental health service %K mental health services %K interface %K system usability %K usability %K digital health %K machine learning %K ML %K artificial intelligence %K AI %K algorithm %K algorithms %K NLP %K natural language processing %D 2024 %7 29.4.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: The use of chatbots in mental health support has increased exponentially in recent years, with studies showing that they may be effective in treating mental health problems. More recently, the use of visual avatars called digital humans has been introduced. Digital humans have the capability to use facial expressions as another dimension in human-computer interactions. It is important to study the difference in emotional response and usability preferences between text-based chatbots and digital humans for interacting with mental health services. Objective: This study aims to explore to what extent a digital human interface and a text-only chatbot interface differed in usability when tested by healthy participants, using BETSY (Behavior, Emotion, Therapy System, and You) which uses 2 distinct interfaces: a digital human with anthropomorphic features and a text-only user interface. We also set out to explore how chatbot-generated conversations on mental health (specific to each interface) affected self-reported feelings and biometrics. Methods: We explored to what extent a digital human with anthropomorphic features differed from a traditional text-only chatbot regarding perception of usability through the System Usability Scale, emotional reactions through electroencephalography, and feelings of closeness. Healthy participants (n=45) were randomized to 2 groups that used a digital human with anthropomorphic features (n=25) or a text-only chatbot with no such features (n=20). The groups were compared by linear regression analysis and t tests. Results: No differences were observed between the text-only and digital human groups regarding demographic features. The mean System Usability Scale score was 75.34 (SD 10.01; range 57-90) for the text-only chatbot versus 64.80 (SD 14.14; range 40-90) for the digital human interface. Both groups scored their respective chatbot interfaces as average or above average in usability. Women were more likely to report feeling annoyed by BETSY. Conclusions: The text-only chatbot was perceived as significantly more user-friendly than the digital human, although there were no significant differences in electroencephalography measurements. Male participants exhibited lower levels of annoyance with both interfaces, contrary to previously reported findings. %M 38683664 %R 10.2196/54581 %U https://humanfactors.jmir.org/2024/1/e54581 %U https://doi.org/10.2196/54581 %U http://www.ncbi.nlm.nih.gov/pubmed/38683664 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55491 %T A Hybrid Digital Parenting Program Delivered Within the Malaysian Preschool System: Protocol for a Feasibility Study of a Small-Scale Factorial Cluster Randomized Trial %A Cooper,Hal %A Nadzri,Farah Zeehan Mohd %A Vyas,Seema %A Juhari,Rumaya %A Ismail,Nellie %A Arshat,Zarinah %A Rajandiran,Durgesh %A Markle,Laurie %A Calderon,Francisco %A Vallance,Inge %A Melendez-Torres,G J %A Facciolà,Chiara %A Senesathith,Vanisa %A Gardner,Frances %A Lachman,Jamie M %+ Department of Social Policy and Intervention, University of Oxford, Barnett House, 32-37 Wellington Square, Oxford, OX1 2ER, United Kingdom, 44 01865 270325, hallam.cooper@spi.ox.ac.uk %K parenting intervention %K chatbot-led public health intervention %K engagement %K implementation science %K feasibility %K evidence-based program %D 2024 %7 26.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The United Nations’ Sustainable Development Goal 4, and particularly target 4.2, which seeks to ensure that, by 2030, all children have access to quality early childhood development, care, and preprimary education so that they are ready for primary education, is far from being achieved. The COVID-19 pandemic compromised progress by disrupting education, reducing access to well-being resources, and increasing family violence. Evidence from low- and middle-income countries suggests that in-person parenting interventions are effective at improving child learning and preventing family violence. However, scaling up these programs is challenging because of resource constraints. Integrating digital and human-delivered intervention components is a potential solution to these challenges. There is a need to understand the feasibility and effectiveness of such interventions in low-resource settings. Objective: This study aims to determine the feasibility and effectiveness of a digital parenting program (called Naungan Kasih in Bahasa Melayu [Protection through Love]) delivered in Malaysia, with varying combinations of 2 components included to encourage engagement. The study is framed around the following objectives: (1) to determine the recruitment, retention, and engagement rates in each intervention condition; (2) to document implementation fidelity; (3) to explore program acceptability among key stakeholders; (4) to estimate intervention costs; and (5) to provide indications of the effectiveness of the 2 components. Methods: This 10-week factorial cluster randomized trial compares ParentText, a chatbot that delivers parenting and family violence prevention content to caregivers of preschool-aged children in combination with 2 engagement components: (1) a WhatsApp support group and (2) either 1 or 2 in-person sessions. The trial aims to recruit 160 primary and 160 secondary caregivers of children aged 4-6 years from 8 schools split equally across 2 locations: Kuala Lumpur and Negeri Sembilan. The primary outcomes concern the feasibility and acceptability of the intervention and its components, including recruitment, retention, and engagement. The effectiveness outcomes include caregiver parenting practices, mental health and relationship quality, and child development. The evaluation involves mixed methods: quantitative caregiver surveys, digitally tracked engagement data of caregivers’ use of the digital intervention components, direct assessments of children, and focus group discussions with caregivers and key stakeholders. Results: Overall, 208 parents were recruited at baseline December 2023: 151 (72.6%) primary caregivers and 57 (27.4%) secondary caregivers. In January 2024, of these 208 parents, 168 (80.8%) enrolled in the program, which was completed in February. Postintervention data collection was completed in March 2024. Findings will be reported in the second half of 2024. Conclusions: This is the first factorial cluster randomized trial to assess the feasibility of a hybrid human-digital playful parenting program in Southeast Asia. The results will inform a large-scale optimization trial to establish the most effective, cost-effective, and scalable version of the intervention. Trial Registration: OSF Registries; https://osf.io/f32ky International Registered Report Identifier (IRRID): DERR1-10.2196/55491 %M 38669679 %R 10.2196/55491 %U https://www.researchprotocols.org/2024/1/e55491 %U https://doi.org/10.2196/55491 %U http://www.ncbi.nlm.nih.gov/pubmed/38669679 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e55364 %T Digital Interventions for Combating Internet Addiction in Young Children: Qualitative Study of Parent and Therapist Perspectives %A Theopilus,Yansen %A Al Mahmud,Abdullah %A Davis,Hilary %A Octavia,Johanna Renny %+ Centre for Design Innovation, Swinburne University of Technology, John St, Hawthorn, Melbourne, 3122, Australia, 61 39214383, aalmahmud@swin.edu.au %K addiction therapist %K children %K digital intervention %K internet addiction %K digital devices %K parents %K parental control %K mobile phone %D 2024 %7 26.4.2024 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Internet addiction is an emerging mental health issue in this digital age. Nowadays, children start using the internet in early childhood, thus making them vulnerable to addictive use. Previous studies have reported that the risk of internet addiction tends to be higher in lower-income regions with lower quality of life, such as Indonesia. Indonesia has high risks and prevalence of internet addiction, including in children. Digital interventions have been developed as an option to combat internet addiction in children. However, little is known about what parents and therapists in Indonesia perceive about these types of interventions. Objective: This study aims to investigate the experiences, perceptions, and considerations of parents and therapists regarding digital interventions for combating internet addiction in young Indonesian children. Methods: This study used a qualitative exploratory approach through semistructured interviews. We involved 22 parents of children aged 7 to 11 years and 6 experienced internet addiction therapists for children. The interview data were transcribed and analyzed using thematic analysis. Results: Participants in this study recognized 3 existing digital interventions to combat internet addiction: Google Family Link, YouTube Kids, and Apple parental control. They perceived that digital interventions could be beneficial in continuously promoting healthy digital behavior in children and supporting parents in supervision. However, the existing interventions were not highly used due to limitations such as the apps’ functionality and usability, parental capability, parent-child relationships, cultural incompatibility, and data privacy. Conclusions: The findings suggest that digital interventions should focus not only on restricting and monitoring screen time but also on suggesting substitutive activities for children, developing children’s competencies to combat addictive behavior, improving digital literacy in children and parents, and supporting parental decision-making to promote healthy digital behavior in their children. Suggestions for future digital interventions are provided, such as making the existing features more usable and relatable, investigating gamification features to enhance parental motivation and capability in managing their children’s internet use, providing tailored or personalized content to suit users’ characteristics, and considering the provision of training and information about the use of interventions and privacy agreements. %M 38669672 %R 10.2196/55364 %U https://pediatrics.jmir.org/2024/1/e55364 %U https://doi.org/10.2196/55364 %U http://www.ncbi.nlm.nih.gov/pubmed/38669672 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e51201 %T An mHealth Intervention Promoting Physical Activity and Healthy Eating in a Family Setting (SMARTFAMILY): Randomized Controlled Trial %A Wunsch,Kathrin %A Fiedler,Janis %A Hubenschmid,Sebastian %A Reiterer,Harald %A Renner,Britta %A Woll,Alexander %+ Institute of Sports and Sports Science, Karlsruhe Institute of Technology, Engler-Bunte-Ring 15, Karlsruhe, 76131, Germany, 49 721608 ext 45431, kathrin.wunsch@kit.edu %K mobile app %K telemedicine %K behavior change %K health behavior %K family %K primary prevention %K exercise %K diet %K food and nutrition %K randomized controlled trial %K accelerometer %K wearable electronic devices %K social-cognitive determinants %K just-in-time adaptive intervention %K digital intervention %K mobile phone %D 2024 %7 26.4.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Numerous smartphone apps are targeting physical activity (PA) and healthy eating (HE), but empirical evidence on their effectiveness for the initialization and maintenance of behavior change, especially in children and adolescents, is still limited. Social settings influence individual behavior; therefore, core settings such as the family need to be considered when designing mobile health (mHealth) apps. Objective: The purpose of this study was to evaluate the effectiveness of a theory- and evidence-based mHealth intervention (called SMARTFAMILY [SF]) targeting PA and HE in a collective family–based setting. Methods: A smartphone app based on behavior change theories and techniques was developed, implemented, and evaluated with a cluster randomized controlled trial in a collective family setting. Baseline (t0) and postintervention (t1) measurements included PA (self-reported and accelerometry) and HE measurements (self-reported fruit and vegetable intake) as primary outcomes. Secondary outcomes (self-reported) were intrinsic motivation, behavior-specific self-efficacy, and the family health climate. Between t0 and t1, families of the intervention group (IG) used the SF app individually and collaboratively for 3 consecutive weeks, whereas families in the control group (CG) received no treatment. Four weeks following t1, a follow-up assessment (t2) was completed by participants, consisting of all questionnaire items to assess the stability of the intervention effects. Multilevel analyses were implemented in R (R Foundation for Statistical Computing) to acknowledge the hierarchical structure of persons (level 1) clustered in families (level 2). Results: Overall, 48 families (CG: n=22, 46%, with 68 participants and IG: n=26, 54%, with 88 participants) were recruited for the study. Two families (CG: n=1, 2%, with 4 participants and IG: n=1, 2%, with 4 participants) chose to drop out of the study owing to personal reasons before t0. Overall, no evidence for meaningful and statistically significant increases in PA and HE levels of the intervention were observed in our physically active study participants (all P>.30). Conclusions: Despite incorporating behavior change techniques rooted in family life and psychological theories, the SF intervention did not yield significant increases in PA and HE levels among the participants. The results of the study were mainly limited by the physically active participants and the large age range of children and adolescents. Enhancing intervention effectiveness may involve incorporating health literacy, just-in-time adaptive interventions, and more advanced features in future app development. Further research is needed to better understand intervention engagement and tailor mHealth interventions to individuals for enhanced effectiveness in primary prevention efforts. Trial Registration: German Clinical Trials Register DRKS00010415; https://drks.de/search/en/trial/DRKS00010415 International Registered Report Identifier (IRRID): RR2-10.2196/20534 %M 38669071 %R 10.2196/51201 %U https://mhealth.jmir.org/2024/1/e51201 %U https://doi.org/10.2196/51201 %U http://www.ncbi.nlm.nih.gov/pubmed/38669071 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e48218 %T Effective Communication Supported by an App for Pregnant Women: Quantitative Longitudinal Study %A Kötting,Lukas %A Anand-Kumar,Vinayak %A Keller,Franziska Maria %A Henschel,Nils Tobias %A Lippke,Sonia %+ Psychology and Methods, School of Business, Social & Decision Sciences, Constructor University Bremen gGmbH, Campus Ring 1, Bremen, 28759, Germany, 49 421 200 4730, s.lippke@jacobs-university.de %K clinical care %K health action process approach %K HAPA %K intention %K communication behavior %K patient safety %K patient education %K internet intervention %K dropout %K digital health %K behavior change %K prediction %K obstetric %K pregnant women %K pregnancy %K safe communication %K health behaviors %K obstetric care %D 2024 %7 26.4.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: In the medical field of obstetrics, communication plays a crucial role, and pregnant women, in particular, can benefit from interventions improving their self-reported communication behavior. Effective communication behavior can be understood as the correct transmission of information without misunderstanding, confusion, or losses. Although effective communication can be trained by patient education, there is limited research testing this systematically with an app-based digital intervention. Thus, little is known about the success of such a digital intervention in the form of a web-app, potential behavioral barriers for engagement, as well as the processes by which such a web-app might improve self-reported communication behavior. Objective: This study fills this research gap by applying a web-app aiming at improving pregnant women’s communication behavior in clinical care. The goals of this study were to (1) uncover the potential risk factors for early dropout from the web-app and (2) investigate the social-cognitive factors that predict self-reported communication behavior after having used the web-app. Methods: In this study, 1187 pregnant women were recruited. They all started to use a theory-based web-app focusing on intention, planning, self-efficacy, and outcome expectancy to improve communication behavior. Mechanisms of behavior change as a result of exposure to the web-app were explored using stepwise regression and path analysis. Moreover, determinants of dropout were tested using logistic regression. Results: We found that dropout was associated with younger age (P=.014). Mechanisms of behavior change were consistent with the predictions of the health action process approach. The stepwise regression analysis revealed that action planning was the best predictor for successful behavioral change over the course of the app-based digital intervention (β=.331; P<.001). The path analyses proved that self-efficacy beliefs affected the intention to communicate effectively, which in turn, elicited action planning and thereby improved communication behavior (β=.017; comparative fit index=0.994; Tucker–Lewis index=0.971; root mean square error of approximation=0.055). Conclusions: Our findings can guide the development and improvement of apps addressing communication behavior in the following ways in obstetric care. First, such tools would enable action planning to improve communication behavior, as action planning is the key predictor of behavior change. Second, younger women need more attention to keep them from dropping out. However, future research should build upon the gained insights by conducting similar internet interventions in related fields of clinical care. The focus should be on processes of behavior change and strategies to minimize dropout rates, as well as replicating the findings with patient safety measures. Trial Registration: ClinicalTrials.gov identifier: NCT03855735; https://classic.clinicaltrials.gov/ct2/show/NCT03855735 %M 38669073 %R 10.2196/48218 %U https://humanfactors.jmir.org/2024/1/e48218 %U https://doi.org/10.2196/48218 %U http://www.ncbi.nlm.nih.gov/pubmed/38669073 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e52687 %T Characterizing Technology Use and Preferences for Health Communication in South Asian Immigrants With Prediabetes or Diabetes: Cross-Sectional Descriptive Study %A Hu,Lu %A Wyatt,Laura C %A Mohsin,Farhan %A Lim,Sahnah %A Zanowiak,Jennifer %A Mammen,Shinu %A Hussain,Sarah %A Ali,Shahmir H %A Onakomaiya,Deborah %A Belli,Hayley M %A Aifah,Angela %A Islam,Nadia S %+ Department of Population Health, Center for Healthful Behavior Change, Institute for Excellence in Health Equity, New York University Grossman School of Medicine, 180 Madison Ave, New York, NY, 10016, United States, 1 646 501 3438, lu.hu@nyulangone.org %K South Asian immigrants %K type 2 diabetes %K technology access %K technology use %K prediabetes %K health disparities %K mHealth %K health equity %K immigrant health %K mobile health %K smartphone %K diabetes %K diabetic %K DM %K diabetes mellitus %K immigrants %K prevention %K regression %K regression model %K logistic regression %K mobile health interventions %D 2024 %7 26.4.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Type 2 diabetes disproportionately affects South Asian subgroups. Lifestyle prevention programs help prevent and manage diabetes; however, there is a need to tailor these programs for mobile health (mHealth). Objective: This study examined technology access, current use, and preferences for health communication among South Asian immigrants diagnosed with or at risk for diabetes, overall and by sex. We examined factors associated with interest in receiving diabetes information by (1) text message, (2) online (videos, voice notes, online forums), and (3) none or skipped, adjusting for sociodemographic characteristics and technology access. Methods: We used baseline data collected in 2019-2021 from two clinical trials among South Asian immigrants in New York City (NYC), with one trial focused on diabetes prevention and the other focused on diabetes management. Descriptive statistics were used to examine overall and sex-stratified impacts of sociodemographics on technology use. Overall logistic regression was used to examine the preference for diabetes information by text message, online (videos, voice notes, or forums), and no interest/skipped response. Results: The overall sample (N=816) had a mean age of 51.8 years (SD 11.0), and was mostly female (462/816, 56.6%), married (756/816, 92.6%), with below high school education (476/816, 58.3%) and limited English proficiency (731/816, 89.6%). Most participants had a smartphone (611/816, 74.9%) and reported interest in receiving diabetes information via text message (609/816, 74.6%). Compared to male participants, female participants were significantly less likely to own smartphones (317/462, 68.6% vs 294/354, 83.1%) or use social media apps (Viber: 102/462, 22.1% vs 111/354, 31.4%; WhatsApp: 279/462, 60.4% vs 255/354, 72.0%; Facebook: Messenger 72/462, 15.6% vs 150/354, 42.4%). A preference for receiving diabetes information via text messaging was associated with male sex (adjusted odds ratio [AOR] 1.63, 95% CI 1.01-2.55; P=.04), current unemployment (AOR 1.62, 95% CI 1.03-2.53; P=.04), above high school education (AOR 2.17, 95% CI 1.41-3.32; P<.001), and owning a smart device (AOR 3.35, 95% CI 2.17-5.18; P<.001). A preference for videos, voice notes, or online forums was associated with male sex (AOR 2.38, 95% CI 1.59-3.57; P<.001) and ownership of a smart device (AOR 5.19, 95% CI 2.83-9.51; P<.001). No interest/skipping the question was associated with female sex (AOR 2.66, 95% CI 1.55-4.56; P<.001), high school education or below (AOR 2.02, 95% CI 1.22-3.36; P=.01), not being married (AOR 2.26, 95% CI 1.13-4.52; P=.02), current employment (AOR 1.96, 95% CI 1.18-3.29; P=.01), and not owning a smart device (AOR 2.06, 95% CI 2.06-5.44; P<.001). Conclusions: Technology access and social media usage were moderately high in primarily low-income South Asian immigrants in NYC with prediabetes or diabetes. Sex, education, marital status, and employment were associated with interest in mHealth interventions. Additional support to South Asian women may be required when designing and developing mHealth interventions. Trial Registration: ClinicalTrials.gov NCT03333044; https://classic.clinicaltrials.gov/ct2/show/NCT03333044, ClinicalTrials.gov NCT03188094; https://classic.clinicaltrials.gov/ct2/show/NCT03188094 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-019-3711-y %M 38669062 %R 10.2196/52687 %U https://formative.jmir.org/2024/1/e52687 %U https://doi.org/10.2196/52687 %U http://www.ncbi.nlm.nih.gov/pubmed/38669062 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e55552 %T Remote Short Sessions of Heart Rate Variability Biofeedback Monitored With Wearable Technology: Open-Label Prospective Feasibility Study %A Hirten,Robert P %A Danieletto,Matteo %A Landell,Kyle %A Zweig,Micol %A Golden,Eddye %A Pyzik,Renata %A Kaur,Sparshdeep %A Chang,Helena %A Helmus,Drew %A Sands,Bruce E %A Charney,Dennis %A Nadkarni,Girish %A Bagiella,Emilia %A Keefer,Laurie %A Fayad,Zahi A %+ The Dr Henry D Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, 1 Gustave L Levy Place, New York, NY, 10029, United States, 1 212 241 6500, robert.hirten@mountsinai.org %K biofeedback %K digital health %K digital technology %K health care worker %K HCW %K heart rate variability %K mHealth %K mobile health %K mobile phone %K remote monitoring %K smartphone %K wearable devices %D 2024 %7 25.4.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Heart rate variability (HRV) biofeedback is often performed with structured education, laboratory-based assessments, and practice sessions. It has been shown to improve psychological and physiological function across populations. However, a means to remotely use and monitor this approach would allow for wider use of this technique. Advancements in wearable and digital technology present an opportunity for the widespread application of this approach. Objective: The primary aim of the study was to determine the feasibility of fully remote, self-administered short sessions of HRV-directed biofeedback in a diverse population of health care workers (HCWs). The secondary aim was to determine whether a fully remote, HRV-directed biofeedback intervention significantly alters longitudinal HRV over the intervention period, as monitored by wearable devices. The tertiary aim was to estimate the impact of this intervention on metrics of psychological well-being. Methods: To determine whether remotely implemented short sessions of HRV biofeedback can improve autonomic metrics and psychological well-being, we enrolled HCWs across 7 hospitals in New York City in the United States. They downloaded our study app, watched brief educational videos about HRV biofeedback, and used a well-studied HRV biofeedback program remotely through their smartphone. HRV biofeedback sessions were used for 5 minutes per day for 5 weeks. HCWs were then followed for 12 weeks after the intervention period. Psychological measures were obtained over the study period, and they wore an Apple Watch for at least 7 weeks to monitor the circadian features of HRV. Results: In total, 127 HCWs were enrolled in the study. Overall, only 21 (16.5%) were at least 50% compliant with the HRV biofeedback intervention, representing a small portion of the total sample. This demonstrates that this study design does not feasibly result in adequate rates of compliance with the intervention. Numerical improvement in psychological metrics was observed over the 17-week study period, although it did not reach statistical significance (all P>.05). Using a mixed effect cosinor model, the mean midline-estimating statistic of rhythm (MESOR) of the circadian pattern of the SD of the interbeat interval of normal sinus beats (SDNN), an HRV metric, was observed to increase over the first 4 weeks of the biofeedback intervention in HCWs who were at least 50% compliant. Conclusions: In conclusion, we found that using brief remote HRV biofeedback sessions and monitoring its physiological effect using wearable devices, in the manner that the study was conducted, was not feasible. This is considering the low compliance rates with the study intervention. We found that remote short sessions of HRV biofeedback demonstrate potential promise in improving autonomic nervous function and warrant further study. Wearable devices can monitor the physiological effects of psychological interventions. %M 38663011 %R 10.2196/55552 %U https://mental.jmir.org/2024/1/e55552 %U https://doi.org/10.2196/55552 %U http://www.ncbi.nlm.nih.gov/pubmed/38663011 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e56417 %T Smartphone-Based Speech Therapy for Poststroke Dysarthria: Pilot Randomized Controlled Trial Evaluating Efficacy and Feasibility %A Kim,Yuyoung %A Kim,Minjung %A Kim,Jinwoo %A Song,Tae-Jin %+ Department of Neurology, Seoul Hospital, Ewha Womans University College of Medicine, 22, Ewhayeodae 1an-gil, Seodaemun-gu, Seoul, 03766, Republic of Korea, 82 10 8919 8764, knstar@ewha.ac.kr %K dysarthria %K stroke %K smartphone %K speech therapy %K app %K acute and early subacute %K feasibility %K mobile phone %D 2024 %7 25.4.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Dysarthria is a common poststroke speech disorder affecting communication and psychological well-being. Traditional speech therapy is effective but often poses challenges in terms of accessibility and patient adherence. Emerging smartphone-based therapies may offer promising alternatives for the treatment of poststroke dysarthria. Objective: This study aimed to assess the efficacy and feasibility of smartphone-based speech therapy for improving speech intelligibility in patients with acute and early subacute poststroke dysarthria. This study also explored the impact of the intervention on psychological well-being, user experience, and overall feasibility in a clinical setting. Methods: Participants were divided into 2 groups for this randomized, evaluator-blinded trial. The intervention group used a smartphone-based speech therapy app for 1 hour per day, 5 days per week, for 4 weeks, with guideline-based standard stroke care. The control group received standard guideline-based stroke care and rehabilitation. Speech intelligibility, psychological well-being, quality of life, and user acceptance were assessed using repeated measures ANOVA. Results: In this study, 40 patients with poststroke dysarthria were enrolled, 32 of whom completed the trial (16 in each group). The intervention group showed significant improvements in speech intelligibility compared with the control group. This was evidenced by improvements from baseline (F1,30=34.35; P<.001), between-group differences (F1,30=6.18; P=.02), and notable time-by-group interactions (F1,30=6.91; P=.01). Regarding secondary outcomes, the intervention led to improvements in the percentage of correct consonants over time (F1,30=5.57; P=.03). In addition, significant reductions were noted in the severity of dysarthria in the intervention group over time (F1,30=21.18; P<.001), with a pronounced group effect (F1,30=5.52; P=.03) and time-by-group interaction (F1,30=5.29; P=.03). Regarding quality of life, significant improvements were observed as measured by the EQ-5D-3L questionnaire (F1,30=13.25; P<.001) and EQ-VAS (F1,30=7.74; P=.009) over time. The adherence rate to the smartphone-based app was 64%, with over half of the participants completing all the sessions. The usability of the app was rated high (system usability score 80.78). In addition, the intervention group reported increased self-efficacy in using the app compared with the control group (F1,30=10.81; P=.003). Conclusions: The smartphone-based speech therapy app significantly improved speech intelligibility, articulation, and quality of life in patients with poststroke dysarthria. These findings indicate that smartphone-based speech therapy can be a useful assistant device in the management of poststroke dysarthria, particularly in the acute and early subacute stroke stages. Trial Registration: ClinicalTrials.gov NCT05146765; https://clinicaltrials.gov/ct2/show/NCT05146765 %M 38509662 %R 10.2196/56417 %U https://www.jmir.org/2024/1/e56417 %U https://doi.org/10.2196/56417 %U http://www.ncbi.nlm.nih.gov/pubmed/38509662 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e51949 %T Digital Therapeutic (Mika) Targeting Distress in Patients With Cancer: Results From a Nationwide Waitlist Randomized Controlled Trial %A Springer,Franziska %A Maier,Ayline %A Friedrich,Michael %A Raue,Jan Simon %A Finke,Gandolf %A Lordick,Florian %A Montgomery,Guy %A Esser,Peter %A Brock,Hannah %A Mehnert-Theuerkauf,Anja %+ Department of Medical Psychology and Medical Sociology, Comprehensive Cancer Center Central Germany, University Medical Center Leipzig, Philipp-Rosenthal-Str. 55, Haus W, Leipzig, 04103, Germany, 49 341 97 18800, Anja.Mehnert@medizin.uni-leipzig.de %K digital therapeutic %K digital health %K mobile health %K app %K cancer %K randomized controlled trial %K supportive care %K oncology %K access to care %K distress %K depression %K anxiety %K fatigue %K mobile phone %D 2024 %7 25.4.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Distress is highly prevalent among patients with cancer, but supportive care needs often go unmet. Digital therapeutics hold the potential to overcome barriers in cancer care and improve health outcomes. Objective: This study conducted a randomized controlled trial to investigate the efficacy of Mika, an app-based digital therapeutic designed to reduce distress across the cancer trajectory. Methods: This nationwide waitlist randomized controlled trial in Germany enrolled patients with cancer across all tumor entities diagnosed within the last 5 years. Participants were randomized into the intervention (Mika plus usual care) and control (usual care alone) groups. The participants completed web-based assessments at baseline and at 2, 6, and 12 weeks. The primary outcome was the change in distress from baseline to week 12, as measured by the National Comprehensive Cancer Network Distress Thermometer. Secondary outcomes included depression, anxiety (Hospital Anxiety and Depression Scale), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue), and quality of life (Clinical Global Impression-Improvement Scale). Intention-to-treat and per-protocol analyses were performed. Analyses of covariance were used to test for outcome changes over time between the groups, controlling for baseline. Results: A total of 218 patients (intervention: n=99 and control: n=119) were included in the intention-to-treat analysis. Compared with the control group, the intervention group reported greater reductions in distress (P=.03; ηp²=0.02), depression (P<.001; ηp²=0.07), anxiety (P=.03; ηp²=0.02), and fatigue (P=.04; ηp²=0.02). Per-protocol analyses revealed more pronounced treatment effects, with the exception of fatigue. No group difference was found for quality of life. Conclusions: Mika effectively diminished distress in patients with cancer. As a digital therapeutic solution, Mika offers accessible, tailored psychosocial and self-management support to address the unmet needs in cancer care. Trial Registration: German Clinical Trials Register (DRKS) DRKS00026038; https://drks.de/search/en/trial/DRKS00026038 %M 38663007 %R 10.2196/51949 %U https://www.jmir.org/2024/1/e51949 %U https://doi.org/10.2196/51949 %U http://www.ncbi.nlm.nih.gov/pubmed/38663007 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e50234 %T Developing Social Enhancements for a Web-Based, Positive Emotion Intervention for Alzheimer Disease Caregivers: Qualitative Focus Group and Interview Study %A Kwok,Ian %A Lattie,Emily Gardiner %A Yang,Dershung %A Summers,Amanda %A Cotten,Paul %A Leong,Caroline Alina %A Moskowitz,Judith Tedlie %+ Feinberg School of Medicine, Northwestern University, 420 E Superior St, Chicago, IL, 60611, United States, 1 323 364 1160, iankwok@u.northwestern.edu %K Alzheimer disease %K dementia %K caregiving %K eHealth %K web-based interventions %K positive emotion %K stress %K coping %D 2024 %7 25.4.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Alzheimer disease is a degenerative neurological condition that requires long-term care. The cost of these responsibilities is often borne by informal caregivers, who experience an elevated risk of negative physical and psychological outcomes. Previously, we designed a positive emotion regulation intervention that was shown to improve well-being among dementia caregivers when delivered through one-on-one videoconferencing lessons with a trained facilitator. However, the format required significant resources in terms of logistics and facilitator time. To broaden the reach of the intervention, we aimed to develop the Social Augmentation of Self-Guided Electronic Delivery of the Life Enhancing Activities for Family Caregivers (SAGE LEAF) program, an iteration of the intervention in a self-guided, web-based format with enhanced opportunities for social connection. Objective: The aim of this study was to gather feedback to inform the design of social features for the SAGE LEAF intervention. In the absence of a facilitator, our goal with the self-guided SAGE LEAF intervention was to integrate various social features (eg, discussion board, automated support, and profiles) to maximize engagement among participants. Methods: Qualitative data were collected from 26 individuals through (1) interviews with participants who completed a previous version of the intervention via videoconferencing with a facilitator, (2) focus groups with dementia caregivers who had not previously experienced the intervention, and (3) focus groups with Alzheimer disease clinical care providers. We conducted a qualitative thematic analysis to identify which social features would be the most helpful and how they could be implemented in a way that would be best received by caregivers. Results: Interview and focus group feedback indicated that participants generally liked the potential features suggested, including the discussion boards, multimedia content, and informational support. They had valuable suggestions for optimal implementation. For example, participants liked the idea of a buddy system where they would be matched up with another caregiver for the duration of the study. However, they expressed concern about differing expectations among caregivers and the possibility of matched caregivers not getting along. Participants also expressed interest in giving caregivers access to a podcast on the skills, which would allow them to review additional content when they wished. Conclusions: Taken together, the discussions with caregivers and providers offered unique insights into the types of social features that may be integrated into the SAGE LEAF intervention, as well as implementation suggestions to improve the acceptability of the features among caregivers. These insights will allow us to design social features for the intervention that are optimally engaging and helpful for caregivers. %M 38662432 %R 10.2196/50234 %U https://formative.jmir.org/2024/1/e50234 %U https://doi.org/10.2196/50234 %U http://www.ncbi.nlm.nih.gov/pubmed/38662432 %0 Journal Article %@ 2291-5222 %I %V 12 %N %P e44463 %T Effects of a Planned Web-Based Educational Intervention Based on the Health Belief Model for Patients With Ischemic Stroke in Promoting Secondary Prevention During the COVID-19 Lockdown in China: Quasi-Experimental Study %A Liu,Zhuo %A Sun,Xin %A Guo,Zhen-Ni %A Sun,Ye %A Yang,Yi %A Yan,Xiuli %K health belief model %K health education %K secondary prevention %K stroke %K medication adherence %K patient education %K web-based education %K digital intervention %K promotion %K stroke patients %K ischemic %K prevention %K quasi-experimental study %K education %K control group %K health management %K management %K systolic blood pressure %K blood pressure %K effectiveness %K medication adherence %D 2024 %7 24.4.2024 %9 %J JMIR Mhealth Uhealth %G English %X Background: Some common modified vascular risk factors remain poorly controlled among stroke survivors, and educational programs may help improve these conditions. Objective: This study aimed to evaluate the effect of a planned web-based educational intervention based on the health belief model (HBM) in promoting secondary prevention among patients with ischemic stroke. Methods: An evaluation-blinded quasi-experimental trial with a historical control group was conducted. Patients admitted from March to June 2020 were assigned to the historical control group, and patients admitted from July to October 2020 were assigned to the intervention group. The control group received routine health management. The intervention group received 6 additional sessions based on the HBM via Tencent Meeting, an audio and video conferencing application, within 3 months after discharge. Sessions were held every 2 weeks, with each session lasting approximately 40 minutes. These sessions were conducted in small groups, with about 8 to 10 people in each group. The primary outcomes were changes in blood pressure (BP), low-density lipoprotein cholesterol (LDL-C), hemoglobin A1c (HbA1c), and the proportion of patients achieving the treatment target. The secondary outcomes were medication adherence, assessed with the Morisky Medicine Adherence Scale (MMAS), and disability, assessed with the modified Rankin scale. Results: In total, 315 patients experiencing their first-ever stroke were analyzed. More patients in the intervention group had controlled BP (41.9% vs 28.4%; adjusted odds ratio [aOR] 1.93; P=.01), LDL-C (83.1% vs 67.7%; aOR 2.66; P=.001), and HbA1c (91.9% vs 83.9%; aOR: 3.37; P=.04) levels as well as a significant postintervention decrease in the systolic BP (adjusted β −3.94; P=.02), LDL-C (adjusted β −0.21; P=.008), and HbA1c (adjusted β −0.27; P<.001), compared with control groups. Significant between-group differences were observed in medication adherence (79.4% vs 63.2%; aOR 2.31; P=.002) but not in favorable functional outcomes. Conclusions: A web-based education program based on the HBM may be more effective than current methods used to educate patients having strokes on optimal vascular risk factors and medication adherence. Trial Registration: Chinese Clinical Trial Registry ChiCTR2000040804; https://www.chictr.org.cn/showproj.html?proj=62431 %R 10.2196/44463 %U https://mhealth.jmir.org/2024/1/e44463 %U https://doi.org/10.2196/44463 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e52090 %T An Integrated mHealth App for Smoking Cessation in Black Smokers With HIV: Protocol for a Randomized Controlled Trial %A Bizier,Andre %A Jones,Arielle %A Businelle,Michael %A Kezbers,Krista %A Hoeppner,Bettina B %A Giordano,Thomas P %A Thai,Jessica M %A Charles,Jacqueline %A Montgomery,Audrey %A Gallagher,Matthew W %A Cheney,Marshall K %A Zvolensky,Michael %A Garey,Lorra %+ University of Houston, 3695 Cullen Blvd, Fred J. Heyne Building, Suite 126, Houston, TX, United States, 1 7137438056, llgarey@uh.edu %K smoking cessation %K Black %K HIV %K anxiety sensitivity %K mobile health %K mHealth %K just-in-time adaptive intervention %K mobile phone %D 2024 %7 24.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Black adults who smoke and have HIV experience immense stressors (eg, racial discrimination and HIV stigma) that impede smoking cessation success and perpetuate smoking-related health disparities. These stressors also place Black adults who smoke and have HIV at an increased risk of elevated interoceptive stress (eg, anxiety and uncomfortable bodily sensations) and smoking to manage symptoms. In turn, this population is more likely to smoke to manage interoceptive stress, which contributes to worse HIV-related outcomes in this group. However, no specialized treatment exists to address smoking cessation, interoceptive stress, and HIV management for Black smokers with HIV. Objective: This study aims to test a culturally adapted and novel mobile intervention that targets combustible cigarette smoking, HIV treatment engagement and adherence, and anxiety sensitivity (a proxy for difficulty and responsivity to interoceptive stress) among Black smokers with HIV (ie, Mobile Anxiety Sensitivity Program for Smoking and HIV [MASP+]). Various culturally tailored components of the app are being evaluated for their ability to help users quit smoking, manage physiological stress, and improve health care management. Methods: This study is a pilot randomized controlled trial in which Black combustible cigarette smokers with HIV (N=72) are being recruited and randomly assigned to use either (1) the National Cancer Institute’s QuitGuide app or (2) MASP+. Study procedures include a web-based prescreener; active intervention period for 6 weeks; smartphone-based assessments, including daily app-based ecological momentary assessments for 6 weeks (4 ecological momentary assessments each day); a video-based qualitative interview using Zoom Video Communications software at week 6 for participants in all study conditions; and smartphone-based follow-up assessments at 0, 1, 2 (quit date), 3, 4, 5, 6, and 28 weeks postbaseline (26 weeks postquitting date). Results: Primary outcomes include biochemically verified 7-day point prevalence of abstinence, HIV-related quality of life, use of antiretroviral therapy, and HIV care appointment adherence at 26 weeks postquitting date. Qualitative data are also being collected and assessed to obtain feedback that will guide further tailoring of app content and evaluation of efficacy. Conclusions: The results of this study will determine whether the MASP+ app serves as a successful aid for combustible cigarette smoking cessation, HIV treatment engagement, and physiological stress outcomes among Black people with HIV infection. If successful, this study will provide evidence for the efficacy of a new means of addressing major mental and physical health difficulties for this high-risk population. If the results are promising, the data from this study will be used to update and tailor the MASP+ app for testing in a fully powered randomized controlled trial that will evaluate its efficacy in real-world behavioral health and social service settings. Trial Registration: ClinicalTrials.gov NCT05709002; https://clinicaltrials.gov/study/NCT05709002 International Registered Report Identifier (IRRID): PRR1-10.2196/52090 %M 38657227 %R 10.2196/52090 %U https://www.researchprotocols.org/2024/1/e52090 %U https://doi.org/10.2196/52090 %U http://www.ncbi.nlm.nih.gov/pubmed/38657227 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e48725 %T Behavior Change Approaches in Digital Technology–Based Physical Rehabilitation Interventions Following Stroke: Scoping Review %A Gooch,Helen J %A Jarvis,Kathryn A %A Stockley,Rachel C %+ Stroke Research Team, School of Nursing and Midwifery, University of Central Lancashire, BB247 Brook Building, Victoria Street, Preston, PR1 2HE, United Kingdom, 44 1772894956, HJGooch@uclan.ac.uk %K behavior change %K behavior therapy %K digital health technology %K digital health %K digital technology %K health behavior %K physical and rehabilitation medicine %K scoping review %K stroke rehabilitation %D 2024 %7 24.4.2024 %9 Review %J J Med Internet Res %G English %X Background: Digital health technologies (DHTs) are increasingly used in physical stroke rehabilitation to support individuals in successfully engaging with the frequent, intensive, and lengthy activities required to optimize recovery. Despite this, little is known about behavior change within these interventions. Objective: This scoping review aimed to identify if and how behavior change approaches (ie, theories, models, frameworks, and techniques to influence behavior) are incorporated within physical stroke rehabilitation interventions that include a DHT. Methods: Databases (Embase, MEDLINE, PsycINFO, CINAHL, Cochrane Library, and AMED) were searched using keywords relating to behavior change, DHT, physical rehabilitation, and stroke. The results were independently screened by 2 reviewers. Sources were included if they reported a completed primary research study in which a behavior change approach could be identified within a physical stroke rehabilitation intervention that included a DHT. Data, including the study design, DHT used, and behavior change approaches, were charted. Specific behavior change techniques were coded to the behavior change technique taxonomy version 1 (BCTTv1). Results: From a total of 1973 identified sources, 103 (5%) studies were included for data charting. The most common reason for exclusion at full-text screening was the absence of an explicit approach to behavior change (165/245, 67%). Almost half (45/103, 44%) of the included studies were described as pilot or feasibility studies. Virtual reality was the most frequently identified DHT type (58/103, 56%), and almost two-thirds (65/103, 63%) of studies focused on upper limb rehabilitation. Only a limited number of studies (18/103, 17%) included a theory, model, or framework for behavior change. The most frequently used BCTTv1 clusters were feedback and monitoring (88/103, 85%), reward and threat (56/103, 54%), goals and planning (33/103, 32%), and shaping knowledge (33/103, 32%). Relationships between feedback and monitoring and reward and threat were identified using a relationship map, with prominent use of both of these clusters in interventions that included virtual reality. Conclusions: Despite an assumption that DHTs can promote engagement in rehabilitation, this scoping review demonstrates that very few studies of physical stroke rehabilitation that include a DHT overtly used any form of behavior change approach. From those studies that did consider behavior change, most did not report a robust underpinning theory. Future development and research need to explicitly articulate how including DHTs within an intervention may support the behavior change required for optimal engagement in physical rehabilitation following stroke, as well as establish their effectiveness. This understanding is likely to support the realization of the transformative potential of DHTs in stroke rehabilitation. %R 10.2196/48725 %U https://www.jmir.org/2024/1/e48725 %U https://doi.org/10.2196/48725 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e54478 %T The Impact of Video-Based Microinterventions on Attitudes Toward Mental Health and Help Seeking in Youth: Web-Based Randomized Controlled Trial %A Lemmer,Diana %A Moessner,Markus %A Arnaud,Nicolas %A Baumeister,Harald %A Mutter,Agnes %A Klemm,Sarah-Lena %A König,Elisa %A Plener,Paul %A Rummel-Kluge,Christine %A Thomasius,Rainer %A Kaess,Michael %A Bauer,Stephanie %+ Center for Psychotherapy Research, Center for Psychosocial Medicine, University Hospital Heidelberg, Bergheimer Str. 54, Heidelberg, 69115, Germany, 49 6221 56 7345, stephanie.bauer@med.uni-heidelberg.de %K help seeking %K mental health %K stigma %K mental health literacy %K psychoeducation %K web-based experiment %K web-based randomized controlled trial %K microinterventions %K video-based interventions %D 2024 %7 24.4.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Mental health (MH) problems in youth are prevalent, burdening, and frequently persistent. Despite the existence of effective treatment, the uptake of professional help is low, particularly due to attitudinal barriers. Objective: This study evaluated the effectiveness and acceptability of 2 video-based microinterventions aimed at reducing barriers to MH treatment and increasing the likelihood of seeking professional help in young people. Methods: This study was entirely web based and open access. The interventions addressed 5 MH problems: generalized anxiety disorder, depression, bulimia, nonsuicidal self-injury, and problematic alcohol use. Intervention 1 aimed to destigmatize and improve MH literacy, whereas intervention 2 aimed to induce positive outcome expectancies regarding professional help seeking. Of the 2435 participants who commenced the study, a final sample of 1394 (57.25%) participants aged 14 to 29 years with complete data and sufficient durations of stay on the video pages were randomized in a fully automated manner to 1 of the 5 MH problems and 1 of 3 conditions (control, intervention 1, and intervention 2) in a permuted block design. After the presentation of a video vignette, no further videos were shown to the control group, whereas a second, short intervention video was presented to the intervention 1 and 2 groups. Intervention effects on self-reported potential professional help seeking (primary outcome), stigma, and attitudes toward help seeking were examined using analyses of covariance across and within the 5 MH problems. Furthermore, we assessed video acceptability. Results: No significant group effects on potential professional help seeking were found in the total sample (F2,1385=0.99; P=.37). However, the groups differed significantly with regard to stigma outcomes and the likelihood of seeking informal help (F2,1385=3.75; P=.02). Furthermore, separate analyses indicated substantial differences in intervention effects among the 5 MH problems. Conclusions: Interventions to promote help seeking for MH problems may require disorder-specific approaches. The study results can inform future research and public health campaigns addressing adolescents and young adults. Trial Registration: German Clinical Trials Register DRKS00023110; https://drks.de/search/de/trial/DRKS00023110 %M 38656779 %R 10.2196/54478 %U https://www.jmir.org/2024/1/e54478 %U https://doi.org/10.2196/54478 %U http://www.ncbi.nlm.nih.gov/pubmed/38656779 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e48173 %T Remote Symptom Monitoring Using Patient-Reported Outcomes in Patients With Chronic Kidney Disease: Process Evaluation of a Randomized Controlled Trial %A Grove,Birgith Engelst %A de Thurah,Annette %A Ivarsen,Per %A Kvisgaard,Ann Katrine %A Hjollund,Niels Henrik %A Grytnes,Regine %A Schougaard,Liv Marit Valen %+ AmbuFlex, Centre for Patient-Reported Outcomes, Gødstrup Hospital, Møllegade 16, Herning, 7400, Denmark, 45 28904835, bigcri@rm.dk %K chronic kidney disease %K pragmatic randomized controlled trial %K process evaluation %K patient-reported outcome measures %K remote monitoring %K monitoring %K patient-reported outcome %K chronic kidney %K intervention %D 2024 %7 24.4.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: In Denmark, outpatient follow-up for patients with chronic kidney disease (CKD) is changing from in-hospital visits toward more remote health care delivery. The nonuse of remote patient-reported outcomes (PROs) is a well-known challenge, and it can be difficult to explain which mechanisms of interventions influence the outcome. Process evaluation may, therefore, be used to answer important questions on how and why interventions work, aiming to enhance the implications for clinical practice. Objective: This study aimed to provide insight into the intervention process by evaluating (1) the representativity of the study population, (2) patient and physician use patterns, (3) patient adherence to the intervention, and (4) clinical engagement. Methods: A process evaluation determining the reach, dose, fidelity, and clinical engagement was carried out, alongside a multicenter randomized controlled trial (RCT). We developed and implemented an intervention using PRO measures to monitor outpatients remotely. Data were collected for the PRO intervention arms in the RCT from 4 sources: (1) PRO data from the participants to determine personal factors, (2) the web-based PRO system to identify key usage intervention patterns, (3) medical records to identify clinical factors relating to the use of the intervention, and (4) semistructured interviews conducted with involved physicians. Results: Of the 320 patients invited, 152 (47.5%) accepted to participate. The study population reflected the target population. The mean adherence rate to the PRO intervention arms was 82% (95% CI 76-87). The questionnaire response rate was 539/544 (99.1%). A minority of 13 (12.9%) of 101 patients needed assistance to complete study procedures. Physicians assessed 477/539 (88.5%) of the questionnaires. Contact was established in 417/539 (77.4%) of the cases, and 122/539 (22.6%) of the patients did not have contact. Physicians initiated 288/417 (69.1%) and patients requested 129/417 (30.9%) of all the contacts. The primary causes of contact were clinical data (242/417, 58%), PRO data (92/417, 22.1%), and medication concerns and precautionary reasons (83/417, 19.9%). Physicians found the use of PRO measures in remote follow-up beneficial for assessing the patient’s health. The inclusion of self-reported clinical data in the questionnaire motivated physicians to assess patient responses. However, some barriers were emphasized, such as loss of a personal relationship with the patient and the risk of missing important symptoms in the absence of a face-to-face assessment. Conclusions: This study demonstrates the importance and practical use of remote monitoring among patients with CKD. Overall, the intervention was implemented as intended. We observed high patient adherence rates, and the physicians managed most questionnaires. Some physicians worried that distance from the patients made it unfeasible to use their “clinical glance,” posing a potential risk of overlooking crucial patients‘ symptoms. These findings underscore key considerations for the implementation of remote follow-up. Introducing a hybrid approach combining remote and face-to-face consultations may address these concerns. Trial Registration: ClinicalTrials.gov NCT03847766; https://clinicaltrials.gov/study/NCT03847766 %M 38656781 %R 10.2196/48173 %U https://formative.jmir.org/2024/1/e48173 %U https://doi.org/10.2196/48173 %U http://www.ncbi.nlm.nih.gov/pubmed/38656781 %0 Journal Article %@ 2368-7959 %I %V 11 %N %P e51791 %T A Web-Based and Mobile Intervention Program Using a Spaced Education Approach for Workplace Mental Health Literacy: Cluster Randomized Controlled Trial %A Lam,Lawrence T %A Lam,Mary K P %K mHealth %K web-based intervention %K mental health literacy %K psychoeducation %K randomized controlled trial %K workplace %K performance %K worker %K intervention %K digital health %K mental wellness %K promote %K well-being %K mobile health %K technology %D 2024 %7 23.4.2024 %9 %J JMIR Ment Health %G English %X Background: Workplace mental health is an important global health concern. Objectives: This unblinded, phase-III, wait-listed cluster randomized controlled trial aimed to examine the effectiveness of a mobile health (mHealth) psychoeducation program using a spaced education approach on mental health literacy (MHL) in the workplace. The main interest of this paper was the immediate and 3-month medium-term effect of the program on the MHL of workers. The purposely built mHealth platform was also evaluated as a health-related app. Methods: The mHealth platform was designed using the principle of spaced education as a psychoeducation intervention program, with various modules of web-based and mobile materials presented to the participant in a progressive manner. Short quizzes at the end of each module ensured adequate learning, and successful completion qualified the learner to progress to the next level. The trial recruited 456 employees of specific industries with high levels of work-related stress. Participants who were nested in different offices or units were allocated into the intervention and wait-listed control groups using a block randomization process, with the office or unit as the cluster. A separate sample of 70 individual raters were used for the evaluation of the mHealth platform. The Australian National MHL and Stigma Survey and the Mobile Apps Rating Scale were completed through a web-based self-reported survey to assess MHL and evaluate the app. The trial and follow-up data were analyzed by a generalized linear latent and mixed model with adjustments for the clustering effect of work sites and repeated measures. Results: Of the 456 participants in the trial, 236 (51.8%) responded to the follow-up survey. Most MHL outcomes obtained significant results immediately after the intervention and across time. After adjusting for the clustering effect, the postintervention weighted mean scores were significantly higher in the intervention group than the control group for correct recognition of a mental health problem, help seeking, and stigmatization by 0.2 (SE 0.1; P=.003), 0.9 (SE 0.2; P<.001), and 1.8 (SE 0.4; P<.001), respectively. After adjusting for the clustering effect, significant differences across time were found in help-seeking intention (P=.01), stigmatization (P<.001), and social distancing (P<.001). The evaluation of the mHealth program resulted in average scores of the 4 major domains ranging from 3.8 to 4.2, with engagement having the lowest score. Conclusions: The mHealth psychoeducation intervention program using this platform had immediate and 3-month medium-term effects of retaining and improving MHL. The platform was evaluated to have satisfactory performance in terms of functionality, aesthetics, information content, and utility in enhancing MHL. It is anticipated that ongoing development in digital health will provide great benefits in improving the mental health of the global population. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619000464167; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377176 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-019-3748-y %R 10.2196/51791 %U https://mental.jmir.org/2024/1/e51791 %U https://doi.org/10.2196/51791 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e46764 %T Empowering School Staff to Support Pupil Mental Health Through a Brief, Interactive Web-Based Training Program: Mixed Methods Study %A Soneson,Emma %A Howarth,Emma %A Weir,Alison %A Jones,Peter B %A Fazel,Mina %+ Department of Psychiatry, University of Oxford, Warneford Lane, Oxford, OX3 7JX, United Kingdom, 44 1865 613127, emma.soneson@psych.ox.ac.uk %K mental health %K children %K schools %K teachers %K training %K digital intervention %K pupil mental health %K mental health training %K intervention %K empowerment %K student %K pupil %K support %K school staff %K web-based training %D 2024 %7 23.4.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Schools in the United Kingdom and elsewhere are expected to protect and promote pupil mental health. However, many school staff members do not feel confident in identifying and responding to pupil mental health difficulties and report wanting additional training in this area. Objective: We aimed to explore the feasibility of Kognito’s At-Risk for Elementary School Educators, a brief, interactive web-based training program that uses a simulation-based approach to improve school staff’s knowledge and skills in supporting pupil mental health. Methods: We conducted a mixed methods, nonrandomized feasibility study of At-Risk for Elementary School Educators in 6 UK primary schools. Our outcomes were (1) school staff’s self-efficacy and preparedness to identify and respond to pupil mental health difficulties, (2) school staff’s identification of mental health difficulties and increased risk of mental health difficulties, (3) mental health support for identified pupils (including conversations about concerns, documentation of concerns, in-class and in-school support, and referral and access to specialist mental health services), and (4) the acceptability and practicality of the training. We assessed these outcomes using a series of questionnaires completed at baseline (T1), 1 week after the training (T2), and 3 months after the training (T3), as well as semistructured qualitative interviews. Following guidance for feasibility studies, we assessed quantitative outcomes across time points by comparing medians and IQRs and analyzed qualitative data using reflexive thematic analysis. Results: A total of 108 teachers and teaching assistants (TAs) completed T1 questionnaires, 89 (82.4%) completed T2 questionnaires, and 70 (64.8%) completed T3 questionnaires; 54 (50%) completed all 3. Eight school staff members, including teachers, TAs, mental health leads, and senior leaders, participated in the interviews. School staff reported greater confidence and preparedness in identifying and responding to mental health difficulties after completing the training. The proportion of pupils whom they identified as having mental health difficulties or increased risk declined slightly over time (medianT1=10%; medianT2=10%; medianT3=7.4%), but findings suggested a slight increase in accuracy compared with a validated screening measure (the Strengths and Difficulties Questionnaire). In-school mental health support outcomes for identified pupils improved after the training, with increases in formal documentation and communication of concerns as well as provision of in-class and in-school support. Referrals and access to external mental health services remained constant. The qualitative findings indicated that school staff perceived the training as useful, practical, and acceptable. Conclusions: The findings suggest that brief, interactive web-based training programs such as At-Risk for Elementary School Educators are a feasible means to improve the identification of and response to mental health difficulties in UK primary schools. Such training may help address the high prevalence of mental health difficulties in this age group by helping facilitate access to care and support. %M 38652534 %R 10.2196/46764 %U https://www.jmir.org/2024/1/e46764 %U https://doi.org/10.2196/46764 %U http://www.ncbi.nlm.nih.gov/pubmed/38652534 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54254 %T Testing the Effectiveness of an Intervention to Improve Romanian Teachers’ LGBT+-Related Attitudes, Cognitions, Behaviors, and Affect: Protocol for a Randomized Controlled Trial %A Latu,Ioana %A Sălăgean,Nastasia %A Larsen,Torill M B %A Isbasoiu,Andreea Bogdana %A Sava,Florin Alin %+ Department of Psychology, Faculty of Sociology and Psychology, West University of Timisoara, Bulevardul Vasile Pârvan 4, Timisoara, 300223, Romania, 40 7901037222, i.latu@qub.ac.uk %K discrimination %K intervention %K school %K lesbian, gay, bisexual, and transgender %K attitude %K behavior %K cognition %K stigma %K stigmatization %K negative impact %K physical health %K mental health %K minority stress model %K European %K Europe %K Romania %K stress %K young %K student %K students %K undergraduate %K bias %K data analysis %K online intervention %K lesbian, gay, bisexual, and transgender stigma %K sentiment %D 2024 %7 23.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Repeated stigmatization due to group membership constitutes a recurrent stressor with negative impact on physical and mental health (minority stress model). Among European countries, Romania ranks low on LGBT+ (lesbian, gay, bisexual, and transgender people. The “+” represents individuals whose identities do not fit typical binary notions of male and female [nonbinary]) inclusion, with 45% of Romanian LGBT+ respondents reporting discrimination in at least 1 area of life in the year preceding the survey. Importantly, while all LGBT+ people might experience minority stress, younger sexual minority individuals are more prone to the detrimental impacts of stigma on their mental and physical health. As such, interventions are necessary to improve the inclusion climate within schools, where young people spend most of their time. Until now, most interventions addressing this topic have been conducted on undergraduate students in Western countries, with no studies conducted in countries that have widespread anti-LGBT+ attitudes. Objective: This paper describes the research protocol for a randomized controlled trial investigating whether LGBT+ stigma and bias among Romanian school teachers can be reduced using an internet-based intervention focusing on education and contact as primary training elements. Methods: A sample of 175 school teachers will be randomly assigned to either the control or experimental group. The experimental group participants will receive the intervention first and then complete the outcome measures, whereas the control group will complete the outcome measures first and then receive the intervention. The 1-hour multimedia intervention is developed for internet-based delivery under controlled conditions. It includes 2 interactive exercises, 2 recorded presentations, animations, and testimonies from LGBT+ individuals. Data for attitudinal, behavioral, cognitive, and affective measures will be collected during the same session (before or after the intervention, depending on the condition). We also plan to conduct a brief mixed methods follow-up study at 6 to 8 months post participation to investigate potential long-term effects of training. However, due to attrition and lack of experimental control (all participants will have completed the intervention, regardless of the condition), these data will be analyzed and reported separately using a mixed methods approach. Results: This paper details the protocol for the teacher intervention study. Data collection began in December 2022 and was completed by February 2023. Data analysis will be performed upon protocol acceptance. Follow-up measures will be completed in 2024. Results are expected to be submitted for publication following analysis in the spring of 2024. Conclusions: The findings of this study will establish the effectiveness of an internet-based intervention intended to lessen anti-LGBT stigma and sentiment in a nation where these views have long been prevalent. If successful, the intervention could end up serving as a resource for Romanian teachers and guidance counselors in high schools. Trial Registration: ISRCTN 84290049; https://doi.org/10.1186/ISRCTN84290049 International Registered Report Identifier (IRRID): DERR1-10.2196/54254 %M 38652533 %R 10.2196/54254 %U https://www.researchprotocols.org/2024/1/e54254 %U https://doi.org/10.2196/54254 %U http://www.ncbi.nlm.nih.gov/pubmed/38652533 %0 Journal Article %@ 2291-9694 %I %V 12 %N %P e48007 %T Reducing Firearm Access for Suicide Prevention: Implementation Evaluation of the Web-Based “Lock to Live” Decision Aid in Routine Health Care Encounters %A Richards,Julie Angerhofer %A Kuo,Elena %A Stewart,Christine %A Shulman,Lisa %A Parrish,Rebecca %A Whiteside,Ursula %A Boggs,Jennifer M %A Simon,Gregory E %A Rowhani-Rahbar,Ali %A Betz,Marian E %K suicide prevention %K firearm %K internet %K implementation %K suicide %K prevention %K decision aid %K risk %K feasible %K support %K evaluation %K mental health %K electronic health record %K tool %D 2024 %7 22.4.2024 %9 %J JMIR Med Inform %G English %X Background: “Lock to Live” (L2L) is a novel web-based decision aid for helping people at risk of suicide reduce access to firearms. Researchers have demonstrated that L2L is feasible to use and acceptable to patients, but little is known about how to implement L2L during web-based mental health care and in-person contact with clinicians. Objective: The goal of this project was to support the implementation and evaluation of L2L during routine primary care and mental health specialty web-based and in-person encounters. Methods: The L2L implementation and evaluation took place at Kaiser Permanente Washington (KPWA)—a large, regional, nonprofit health care system. Three dimensions from the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) model—Reach, Adoption, and Implementation—were selected to inform and evaluate the implementation of L2L at KPWA (January 1, 2020, to December 31, 2021). Electronic health record (EHR) data were used to purposefully recruit adult patients, including firearm owners and patients reporting suicidality, to participate in semistructured interviews. Interview themes were used to facilitate L2L implementation and inform subsequent semistructured interviews with clinicians responsible for suicide risk mitigation. Audio-recorded interviews were conducted via the web, transcribed, and coded, using a rapid qualitative inquiry approach. A descriptive analysis of EHR data was performed to summarize L2L reach and adoption among patients identified at high risk of suicide. Results: The initial implementation consisted of updates for clinicians to add a URL and QR code referencing L2L to the safety planning EHR templates. Recommendations about introducing L2L were subsequently derived from the thematic analysis of semistructured interviews with patients (n=36), which included (1) “have an open conversation,” (2) “validate their situation,” (3) “share what to expect,” (4) “make it accessible and memorable,” and (5) “walk through the tool.” Clinicians’ interviews (n=30) showed a strong preference to have L2L included by default in the EHR-based safety planning template (in contrast to adding it manually). During the 2-year observation period, 2739 patients reported prior-month suicide attempt planning or intent and had a documented safety plan during the study period, including 745 (27.2%) who also received L2L. Over four 6-month subperiods of the observation period, L2L adoption rates increased substantially from 2% to 29% among primary care clinicians and from <1% to 48% among mental health clinicians. Conclusions: Understanding the value of L2L from users’ perspectives was essential for facilitating implementation and increasing patient reach and clinician adoption. Incorporating L2L into the existing system-level, EHR-based safety plan template reduced the effort to use L2L and was likely the most impactful implementation strategy. As rising suicide rates galvanize the urgency of prevention, the findings from this project, including L2L implementation tools and strategies, will support efforts to promote safety for suicide prevention in health care nationwide. %R 10.2196/48007 %U https://medinform.jmir.org/2024/1/e48007 %U https://doi.org/10.2196/48007 %0 Journal Article %@ 2561-7605 %I %V 7 %N %P e47943 %T Increasing Older Adults’ Social Connectedness: Development and Implementation of a Web-Assisted Acceptance and Commitment Therapy–Based Intervention %A Zarling,Amie %A Kim,Joseph %A Russell,Daniel %A Cutrona,Carolyn %K acceptance and commitment therapy %K psychotherapy %K loneliness %K technology %K lonely %K older adults %K older adult %K gerontology %K geriatric %K geriatrics %K emotion regulation %K mental health %K elder %K elderly %K isolation %K aging %K mHealth %K digital health %K digital mental health %K online health %K online support %K eHealth %K internet %K depression %D 2024 %7 22.4.2024 %9 %J JMIR Aging %G English %X In this article, we will provide a rationale for a web-assisted acceptance and commitment therapy (ACT) approach to loneliness among older adults, drawing upon theories from the literature on adult development and aging, emotion regulation, and loneliness. The intervention program was developed using the principles of ACT, which is a cognitive behavioral approach and unified model of human behavior change and psychological growth. The ACT intervention focuses on developing nonjudgmental present-focused awareness of internal experiences (thoughts, emotions, and memories) through strategies such as acceptance and mindfulness rather than directly modifying or removing them per se. The ACT intervention appears well-suited to assist older adults in coping with the challenges of aging, as the focus is on an individual’s willingness to sit with internal experiences out of one’s control (ie, acceptance), stepping back from negative or critical thoughts and developing greater kindness toward oneself (ie, defusion), discerning what is most important to one’s true self (ie, values), and building larger patterns of effective action based on such values (ie, committed action). The ACT intervention was developed as a resource for older adults who are socially isolated or having difficulty with social connectedness. Eight modules comprise the web-assisted ACT intervention program, which includes reading materials, video clips, and activities. Each module is followed by a summary, a homework assignment, a short quiz to assess learning, and a moderated discussion with a coach. The intervention program begins with reconnecting participants with their values. The goal of the ACT intervention program is to foster flexibility in a participant’s behavior so they can behave consistently with their chosen values, rather than becoming locked into a pattern of behavior that is driven by avoiding distress or discomfort. The ACT intervention approach is both novel and innovative, as it is based on ACT and leverages a behavioral health web platform that is flexible and inclusive in its design. The ACT intervention aims to help older adults become more socially connected, less lonely, and more satisfied with their relationships with other people. The emphasis that ACT places on values and living life in accordance with one’s values renders it an approach ideally suited to older adults. Finally, recommendations for future research regarding this approach to addressing loneliness among older adults is addressed. %R 10.2196/47943 %U https://aging.jmir.org/2024/1/e47943 %U https://doi.org/10.2196/47943 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e48756 %T Effectiveness of an Interactive mHealth App (EVITE) in Improving Lifestyle After a Coronary Event: Randomized Controlled Trial %A Bernal-Jiménez,María Ángeles %A Calle,German %A Gutiérrez Barrios,Alejandro %A Gheorghe,Livia Luciana %A Cruz-Cobo,Celia %A Trujillo-Garrido,Nuria %A Rodríguez-Martín,Amelia %A Tur,Josep A %A Vázquez-García,Rafael %A Santi-Cano,María José %+ Faculty of Nursing and Physiotherapy, University of Cádiz, Avda. Ana de Viya, 52, Cádiz, 11009, Spain, 34 956019042, mariajose.santi@uca.es %K coronary artery disease %K healthy lifestyle %K mHealth %K mobile health %K percutaneous coronary intervention %K randomized controlled trial %K secondary prevention %K therapeutic adherence %D 2024 %7 22.4.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Coronary heart disease is one of the leading causes of mortality worldwide. Secondary prevention is essential, as it reduces the risk of further coronary events. Mobile health (mHealth) technology could become a useful tool to improve lifestyles. Objective: This study aimed to evaluate the effect of an mHealth intervention on people with coronary heart disease who received percutaneous coronary intervention. Improvements in lifestyle regarding diet, physical activity, and smoking; level of knowledge of a healthy lifestyle and the control of cardiovascular risk factors (CVRFs); and therapeutic adherence and quality of life were analyzed. Methods: This was a randomized controlled trial with a parallel group design assigned 1:1 to either an intervention involving a smartphone app (mHealth group) or to standard health care (control group). The app was used for setting aims, the self-monitoring of lifestyle and CVRFs using measurements and records, educating people with access to information on their screens about healthy lifestyles and adhering to treatment, and giving motivation through feedback about achievements and aspects to improve. Both groups were assessed after 9 months. The primary outcome variables were adherence to the Mediterranean diet, frequency of food consumed, patient-reported physical activity, smoking, knowledge of healthy lifestyles and the control of CVRFs, adherence to treatment, quality of life, well-being, and satisfaction. Results: The study analyzed 128 patients, 67 in the mHealth group and 61 in the control group; most were male (92/128, 71.9%), with a mean age of 59.49 (SD 8.97) years. Significant improvements were observed in the mHealth group compared with the control group regarding adherence to the Mediterranean diet (mean 11.83, SD 1.74 points vs mean 10.14, SD 2.02 points; P<.001), frequency of food consumption, patient-reported physical activity (mean 619.14, SD 318.21 min/week vs mean 471.70, SD 261.43 min/week; P=.007), giving up smoking (25/67, 75% vs 11/61, 42%; P=.01), level of knowledge of healthy lifestyles and the control of CVRFs (mean 118.70, SD 2.65 points vs mean 111.25, SD 9.05 points; P<.001), and the physical component of the quality of life 12-item Short Form survey (SF-12; mean 45.80, SD 10.79 points vs mean 41.40, SD 10.78 points; P=.02). Overall satisfaction was higher in the mHealth group (mean 48.22, SD 3.89 vs mean 46.00, SD 4.82 points; P=.002) and app satisfaction and usability were high (mean 44.38, SD 6.18 out of 50 points and mean 95.22, SD 7.37 out of 100). Conclusions: The EVITE app was effective in improving the lifestyle of patients in terms of adherence to the Mediterranean diet, frequency of healthy food consumption, physical activity, giving up smoking, knowledge of healthy lifestyles and controlling CVRFs, quality of life, and overall satisfaction. The app satisfaction and usability were excellent. Trial Registration: Clinicaltrials.gov NCT04118504; https://clinicaltrials.gov/study/NCT04118504 %M 38648103 %R 10.2196/48756 %U https://mhealth.jmir.org/2024/1/e48756 %U https://doi.org/10.2196/48756 %U http://www.ncbi.nlm.nih.gov/pubmed/38648103 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53022 %T Capturing the Dynamics of Homelessness Through Ethnography and Mobile Technology: Protocol for the Development and Testing of a Smartphone Technology–Supported Intervention %A Foster,Marva %A Fix,Gemmae M %A Hyde,Justeen %A Dunlap,Shawn %A Byrne,Thomas H %A Sugie,Naomi F %A Kuhn,Randall %A Gabrielian,Sonya %A Roncarati,Jill S %A Zhao,Shibei %A McInnes,D Keith %+ Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, 150 S Huntington Ave, Boston, MA, 02130, United States, 1 857 203 6671, marva.foster@va.gov %K ethnography %K homelessness %K housing transitions %K longitudinal data %K military %K mobile technology %K smartphone %K social support %K veterans %D 2024 %7 22.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: US military veterans who have experienced homelessness often have high rates of housing transition. Disruptions caused by these transitions likely exacerbate this population’s health problems and interfere with access to care and treatment engagement. Individuals experiencing homelessness increasingly use smartphones, contributing to improved access to medical and social services. Few studies have used smartphones as a data collection tool to systematically collect information about the daily life events that precede and contribute to housing transitions, in-the-moment emotions, behaviors, geographic movements, and perceived social support. Objective: The study aims to develop and test a smartphone app to collect longitudinal data from veterans experiencing homelessness (VEH) and to evaluate the feasibility and acceptability of using the app in a population that is unstably housed or homeless. Methods: This study’s design had 3 phases. Phase 1 used ethnographic methods to capture detailed data on day-to-day lived experiences of up to 30 VEH on topics such as housing stability, health, and health behaviors. Phase 2 involved focus groups and usability testing to develop and refine mobile phone data collection methods. Phase 3 piloted the smartphone mobile data collection with 30 VEH. We included mobile ethnography, real-time surveys through an app, and the collection of GPS data in phase 3. Results: The project was launched in June 2020, and at this point, some data collection and analysis for phases 1 and 2 are complete. This project is currently in progress. Conclusions: This multiphase study will provide rich data on the context and immediate events leading to housing transitions among VEH. This study will ensure the development of a smartphone app that will match the actual needs of VEH by involving them in the design process from the beginning. Finally, this study will offer important insights into how best to develop a smartphone app that can help intervene among VEH to reduce housing transitions. International Registered Report Identifier (IRRID): DERR1-10.2196/53022 %M 38648101 %R 10.2196/53022 %U https://www.researchprotocols.org/2024/1/e53022 %U https://doi.org/10.2196/53022 %U http://www.ncbi.nlm.nih.gov/pubmed/38648101 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e53712 %T Testing the Efficacy of a Brief, Self-Guided Mindfulness Ecological Momentary Intervention on Emotion Regulation and Self-Compassion in Social Anxiety Disorder: Randomized Controlled Trial %A Zainal,Nur Hani %A Tan,Hui Han %A Hong,Ryan Yee Shiun %A Newman,Michelle Gayle %+ Department of Psychology, National University of Singapore, 9 Arts Link, Singapore, 117572, Singapore, 65 917 767 7088, hanizainal@nus.edu.sg %K social anxiety disorder %K mindfulness %K ecological momentary intervention %K randomized controlled trial %K emotion regulation %K self-compassion %K mechanisms of change %K mobile phone %K momentary interventions %K self-monitoring app %K regulations %K participant %D 2024 %7 19.4.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Theories propose that brief, mobile, self-guided mindfulness ecological momentary interventions (MEMIs) could enhance emotion regulation (ER) and self-compassion. Such changes are posited to be mechanisms of change. However, rigorous tests of these theories have not been conducted. Objective: In this assessor-blinded, parallel-group randomized controlled trial, we aimed to test these theories in social anxiety disorder (SAD). Methods: Participants with SAD (defined as having a prerandomization cut-off score ≥20 on the Social Phobia Inventory self-report) were randomized to a 14-day fully self-guided MEMI (96/191, 50.3%) or self-monitoring app (95/191, 49.7%) arm. They completed web-based self-reports of 6 clinical outcome measures at prerandomization, 15-day postintervention (administered the day after the intervention ended), and 1-month follow-up time points. ER and self-compassion were assessed at preintervention and 7-day midintervention time points. Multilevel modeling determined the efficacy of MEMI on ER and self-compassion domains from pretrial to midintervention time points. Bootstrapped parallel multilevel mediation analysis examined the mediating role of pretrial to midintervention ER and self-compassion domains on the efficacy of MEMI on 6 clinical outcomes. Results: Participants demonstrated strong compliance, with 78% (149/191) engaging in at least 80% of the MEMI and self-monitoring prompts. MEMI was more efficacious than the self-monitoring app in decreasing ER goal–directed behavior difficulties (between-group Cohen d=−0.24) and lack of emotional clarity (Cohen d=0.16) and increasing self-compassion social connectedness (Cohen d=0.19), nonidentification with emotions (Cohen d=0.16), and self-kindness (Cohen d=0.19) from pretrial to midintervention time points. The within-group effect sizes from pretrial to midintervention were larger in the MEMI arm than in the self-monitoring app arm (ER goal–directed behavior difficulties: Cohen d=−0.73 vs −0.29, lack of emotional clarity: Cohen d=−0.39 vs −0.21, self-compassion domains of social connectedness: Cohen d=0.45 vs 0.19, nonidentification with emotions: Cohen d=0.63 vs 0.48, and self-kindness: Cohen d=0.36 vs 0.10). Self-monitoring, but not MEMI, alleviated ER emotional awareness issues (between-group Cohen d=0.11 and within-group: Cohen d=−0.29 vs −0.13) and reduced self-compassion acknowledging shared human struggles (between-group Cohen d=0.26 and within-group: Cohen d=−0.23 vs 0.13). No ER and self-compassion domains were mediators of the effect of MEMI on SAD symptoms (P=.07-<.99), generalized anxiety symptoms (P=.16-.98), depression severity (P=.20-.94), repetitive negative thinking (P=.12-.96), and trait mindfulness (P=.18-.99) from pretrial to postintervention time points. Similar nonsignificant mediation effects emerged for all of these clinical outcomes from pretrial to 1-month follow-up time points (P=.11-.98). Conclusions: Brief, fully self-guided, mobile MEMIs efficaciously increased specific self-compassion domains and decreased ER difficulties associated with goal pursuit and clarity of emotions from pretrial to midintervention time points. Higher-intensity MEMIs may be required to pinpoint the specific change mechanisms in ER and self-compassion domains of SAD. Trial Registration: Open Science Framework (OSF) Registries; osf.io/m3kxz https://osf.io/m3kxz %M 38640015 %R 10.2196/53712 %U https://mental.jmir.org/2024/1/e53712 %U https://doi.org/10.2196/53712 %U http://www.ncbi.nlm.nih.gov/pubmed/38640015 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54426 %T Telepractice Parent Training of Enhanced Milieu Teaching With Phonological Emphasis (EMT+PE) For Persian-Speaking Toddlers With Nonsyndromic Cleft Palate: Protocol for a Randomized Controlled Trial %A Tahmasebi,Neda %A Zarifian,Talieh %A Ashtari,Atieh %A Biglarian,Akbar %+ Department of Speech Therapy, Pediatric Neurorehabilitation Research Center, University of Social Welfare and Rehabilitation Sciences, Koudakyar Ave, Daneshjou Blv, Tehran, 1985713871, Iran, 98 2122180139, ta.zarifian@uswr.ac.ir %K telepractice %K cleft palate %K language intervention %K parent training %K Phonological Emphasis %K Enhanced Milieu Teaching %K Persian-speaking toddlers %K toddler %K toddlers %K children %K child %K cleft lip %K language development %K speech sound disorders %K speech sound disorder %K effectiveness %K parent-based %K intervention %K speech %K therapy %D 2024 %7 19.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Children born with a cleft palate with or without a cleft lip (CP/L) are at increased risk for delayed language development and speech sound disorders. Enhanced Milieu Teaching with Phonological Emphasis (EMT+PE) is a recommended naturalistic intervention for toddlers with CP/L. The parents’ role in providing naturalistic interventions is critical and they need training based on learning principles to implement these interventions. Telepractice is an appropriate method for training parents and children with various speech-related disorders. Objective: This study aims to determine and compare the effectiveness of telepractice and the parent-implemented EMT+PE intervention on language and speech measures in toddlers with CP/L with usual interventions and determine the effectiveness maintenance of the intervention. Methods: A randomized controlled trial (RCT) will assess the efficacy of telepractice and the parent-implemented EMT+PE intervention in enhancing speech and language measures in toddlers with CP/L. Eligible participants will be randomly assigned to one of 2 groups: the conventional intervention group and the EMT+PE intervention group. Participants’ speech and language measures will be evaluated remotely by trained raters before and after the intervention and 2 months after the intervention. Parents of participants in the intervention group will receive 3 months of training in speech and language supportive strategies from trained therapists using telehealth fidelity scales. Parents of participants in the control group will receive the conventional speech and language intervention by cleft team therapists. Study outcomes will include language variables (mean length of utterance) and speech production variables (percent correct consonants). Results: The protocol was approved by the Research Ethics Committee of the University of Social Welfare and Rehabilitation Sciences in February 2022. The selection process of participants, as well as training therapists and raters, commenced in January 2022, the therapy and follow-up period ended in June 2023, and pre- and postintervention assessments have been conducted. Data analysis is ongoing, and we expect to publish our results by the summer of 2024. Funding is yet to be received. Conclusions: The results of this study may help us develop a speech and language intervention with a different delivery model for toddlers with CP/L, and the cleft team care can use these results in service delivery. Consistent with our hypothesis, speech and language measures are expected to improve. International Registered Report Identifier (IRRID): DERR1-10.2196/54426 %M 38640014 %R 10.2196/54426 %U https://www.researchprotocols.org/2024/1/e54426 %U https://doi.org/10.2196/54426 %U http://www.ncbi.nlm.nih.gov/pubmed/38640014 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e42402 %T Effects of a Web-based Weight Management Education Program on Various Factors for Overweight and Obese Women: Randomized Controlled Trial %A Han,Yunmin %A Sung,Hoyong %A Kim,Geonhui %A Ryu,Yeun %A Yoon,Jiyeon %A Kim,Yeon Soo %+ Department of Physical Education, Seoul National University, Seoul, Gawnak Gu, Gawankro 1, 71-1, 408, Seoul, 08826, Republic of Korea, 82 2 880 7894, kys0101@snu.ac.kr %K weight loss %K obesity %K health education %K self-management %K health promotion %K tailored feedback %K web-based intervention %K behavior change %D 2024 %7 18.4.2024 %9 Original Paper %J JMIR Cardio %G English %X Background: Mediated diet and exercise methods yield effective short-term weight loss but are costly and hard to manage. However, web-based programs can serve many participants, offering ease of access and cost-efficiency. Objective: This study aimed to compare the effectiveness of a web-based weight management program through web-based education alone (MINE) or combined with tailored video feedback (MINE Plus) with a control (CO) group. Methods: This intervention included 60 Korean women with overweight and obesity (BMI≥23 kg/m2) aged 19 years to 39 years old. We randomly allocated 60 participants to each of 3 groups: (1) MINE group (web-based education video and self-monitoring app), (2) MINE Plus group (web-based education video, self-monitoring app, and 1:1 tailored video feedback), and (3) CO group (only self-monitoring app). Web-based education included nutrition, physical activity, psychological factors, medical knowledge for weight loss, goal setting, and cognitive and behavioral strategies. Tailored feedback aimed to motivate and provide solutions via weekly 10-minute real-time video sessions. The intervention lasted 6 weeks, followed by a 6-week observation period to assess the education's lasting effects, with evaluations at baseline, 6 weeks, and 12 weeks. A generalized linear mixed model was used to evaluate time and group interactions. Results: In the intention-to-treat analysis including all 60 participants, there were significant differences in weight change at 6 weeks in the MINE and MINE Plus groups, with mean weight changes of –0.74 (SD 1.96) kg (P=.03) and –1.87 (SD 1.8) kg (P<.001), respectively, while no significant change was observed in the CO group, who had a mean weight increase of 0.03 (SD 1.68) kg (P=.91). After 12 weeks, changes in body weight were –1.65 (SD 2.64) kg in the MINE group, –1.59 (SD 2.79) kg in the MINE Plus group, and 0.43 (SD 1.42) kg in the CO group. There was a significant difference between the MINE and MINE Plus groups (P<.001). Significant group × time effects were found for body weight in the MINE and CO groups (P<.001) and in the MINE Plus and CO groups (P<.001), comparing baseline and 12 weeks. Regarding physical activity and psychological factors, only body shape satisfaction and health self-efficacy were associated with improvements in the MINE and MINE Plus groups (P<.001). Conclusions: This study found that the group receiving education and tailored feedback showed significant weight loss and improvements in several psychological factors, though there were differences in the sustainability of the effects. Trial Registration: Korea Disease Control and Prevention Agency (KDCA) KCT0007780: https://cris.nih.go.kr/cris/search/detailSearch.do/22861 %M 38635975 %R 10.2196/42402 %U https://cardio.jmir.org/2024/1/e42402 %U https://doi.org/10.2196/42402 %U http://www.ncbi.nlm.nih.gov/pubmed/38635975 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e54172 %T A Smartphone App to Support Self-Management for People Living With Sjögren's Syndrome: Qualitative Co-Design Workshops %A McCallum,Claire %A Campbell,Miglena %A Vines,John %A Rapley,Tim %A Ellis,Jason %A Deary,Vincent %A Hackett,Katie %+ Department of Social Work, Education and Community Wellbeing, Northumbria University, Coach Lane Campus West, Newcastle upon Tyne, NE7 7XA, United Kingdom, 44 191 215 6098, kate.hackett@northumbria.ac.uk %K self-management %K mobile health %K mHealth %K eHealth %K Sjögren's syndrome %K patient participation %K patient involvement %K fatigue %K chronic disease %K focus groups %K complex intervention development %K mobile phone %D 2024 %7 17.4.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Sjögren's syndrome (SS) is the second most common autoimmune rheumatic disease, and the range of symptoms includes fatigue, dryness, sleep disturbances, and pain. Smartphone apps may help deliver a variety of cognitive and behavioral techniques to support self-management in SS. However, app-based interventions must be carefully designed to promote engagement and motivate behavior change. Objective: We aimed to explore self-management approaches and challenges experienced by people living with SS and produce a corresponding set of design recommendations that inform the design of an engaging, motivating, and evidence-based self-management app for those living with SS. Methods: We conducted a series of 8 co-design workshops and an additional 3 interviews with participants who were unable to attend a workshop. These were audio recorded, transcribed, and initially thematically analyzed using an inductive approach. Then, the themes were mapped to the Self-Determination Theory domains of competency, autonomy, and relatedness. Results: Participants experienced a considerable demand in the daily work required in self-managing their SS. The condition demanded unrelenting, fluctuating, and unpredictable mental, physical, and social efforts. Participants used a wide variety of techniques to self-manage their symptoms; however, their sense of competency was undermined by the complexity and interconnected nature of their symptoms and affected by interactions with others. The daily contexts in which this labor was occurring revealed ample opportunities to use digital health aids. The lived experience of participants showed that the constructs of competency, autonomy, and relatedness existed in a complex equilibrium with each other. Sometimes, they were disrupted by tensions, whereas on other occasions, they worked together harmoniously. Conclusions: An SS self-management app needs to recognize the complexity and overlap of symptoms and the complexities of managing the condition in daily life. Identifying techniques that target several symptoms simultaneously may prevent users from becoming overwhelmed. Including techniques that support assertiveness and communication with others about the condition, its symptoms, and users’ limitations may support users in their interactions with others and improve engagement in symptom management strategies. For digital health aids (such as self-management apps) to provide meaningful support, they should be designed according to human needs such as competence, autonomy, and relatedness. However, the complexities among the 3 Self-Determination Theory constructs should be carefully considered, as they present both design difficulties and opportunities. %M 38630530 %R 10.2196/54172 %U https://humanfactors.jmir.org/2024/1/e54172 %U https://doi.org/10.2196/54172 %U http://www.ncbi.nlm.nih.gov/pubmed/38630530 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e55031 %T Digital Interventions for Recreational Cannabis Use Among Young Adults: Systematic Review, Meta-Analysis, and Behavior Change Technique Analysis of Randomized Controlled Studies %A Côté,José %A Chicoine,Gabrielle %A Vinette,Billy %A Auger,Patricia %A Rouleau,Geneviève %A Fontaine,Guillaume %A Jutras-Aswad,Didier %+ Research Centre of the Centre Hospitalier de l’Université de Montréal, 850 Saint-Denis, Montreal, QC, H2X 0A9, Canada, 1 514 890 8000, jose.cote@umontreal.ca %K cannabis %K young adults %K digital intervention %K systematic review %K meta-analysis %K behavior change technique analysis %K mobile phone %D 2024 %7 17.4.2024 %9 Review %J J Med Internet Res %G English %X Background: The high prevalence of cannabis use among young adults poses substantial global health concerns due to the associated acute and long-term health and psychosocial risks. Digital modalities, including websites, digital platforms, and mobile apps, have emerged as promising tools to enhance the accessibility and availability of evidence-based interventions for young adults for cannabis use. However, existing reviews do not consider young adults specifically, combine cannabis-related outcomes with those of many other substances in their meta-analytical results, and do not solely target interventions for cannabis use. Objective: We aimed to evaluate the effectiveness and active ingredients of digital interventions designed specifically for cannabis use among young adults living in the community. Methods: We conducted a systematic search of 7 databases for empirical studies published between database inception and February 13, 2023, assessing the following outcomes: cannabis use (frequency, quantity, or both) and cannabis-related negative consequences. The reference lists of included studies were consulted, and forward citation searching was also conducted. We included randomized studies assessing web- or mobile-based interventions that included a comparator or control group. Studies were excluded if they targeted other substance use (eg, alcohol), did not report cannabis use separately as an outcome, did not include young adults (aged 16-35 y), had unpublished data, were delivered via teleconference through mobile phones and computers or in a hospital-based setting, or involved people with mental health disorders or substance use disorders or dependence. Data were independently extracted by 2 reviewers using a pilot-tested extraction form. Authors were contacted to clarify study details and obtain additional data. The characteristics of the included studies, study participants, digital interventions, and their comparators were summarized. Meta-analysis results were combined using a random-effects model and pooled as standardized mean differences. Results: Of 6606 unique records, 19 (0.29%) were included (n=6710 participants). Half (9/19, 47%) of these articles reported an intervention effect on cannabis use frequency. The digital interventions included in the review were mostly web-based. A total of 184 behavior change techniques were identified across the interventions (range 5-19), and feedback on behavior was the most frequently used (17/19, 89%). Digital interventions for young adults reduced cannabis use frequency at the 3-month follow-up compared to control conditions (including passive and active controls) by −6.79 days of use in the previous month (95% CI −9.59 to −4.00; P<.001). Conclusions: Our results indicate the potential of digital interventions to reduce cannabis use in young adults but raise important questions about what optimal exposure dose could be more effective, both in terms of intervention duration and frequency. Further high-quality research is still needed to investigate the effects of digital interventions on cannabis use among young adults. Trial Registration: PROSPERO CRD42020196959; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=196959 %M 38630515 %R 10.2196/55031 %U https://www.jmir.org/2024/1/e55031 %U https://doi.org/10.2196/55031 %U http://www.ncbi.nlm.nih.gov/pubmed/38630515 %0 Journal Article %@ 2291-5222 %I %V 12 %N %P e52074 %T Tailored Prompting to Improve Adherence to Image-Based Dietary Assessment: Mixed Methods Study %A Lee,Lachlan %A Hall,Rosemary %A Stanley,James %A Krebs,Jeremy %K dietary assessment %K diet %K dietary %K nutrition %K mobile phone apps %K image-based dietary assessment %K nutritional epidemiology %K mHealth %K mobile health %K app %K apps %K applications %K applications %K image %K RCT %K randomized %K controlled trial %K controlled trials %K cross-over %K images %K photo %K photographs %K photos %K photograph %K assessment %K prompt %K prompts %K nudge %K nudges %K food %K meal %K meals %K consumption %K behaviour change %K behavior change %D 2024 %7 15.4.2024 %9 %J JMIR Mhealth Uhealth %G English %X Background: Accurately assessing an individual’s diet is vital in the management of personal nutrition and in the study of the effect of diet on health. Despite its importance, the tools available for dietary assessment remain either too imprecise, expensive, or burdensome for clinical or research use. Image-based methods offer a potential new tool to improve the reliability and accessibility of dietary assessment. Though promising, image-based methods are sensitive to adherence, as images cannot be captured from meals that have already been consumed. Adherence to image-based methods may be improved with appropriately timed prompting via text message. Objective: This study aimed to quantitatively examine the effect of prompt timing on adherence to an image-based dietary record and qualitatively explore the participant experience of dietary assessment in order to inform the design of a novel image-based dietary assessment tool. Methods: This study used a randomized crossover design to examine the intraindividual effect of 3 prompt settings on the number of images captured in an image-based dietary record. The prompt settings were control, where no prompts were sent; standard, where prompts were sent at 7:15 AM, 11:15 AM, and 5:15 PM for every participant; and tailored, where prompt timing was tailored to habitual meal times for each participant. Participants completed a text-based dietary record at baseline to determine the timing of tailored prompts. Participants were randomized to 1 of 6 study sequences, each with a unique order of the 3 prompt settings, with each 3-day image-based dietary record separated by a washout period of at least 7 days. The qualitative component comprised semistructured interviews and questionnaires exploring the experience of dietary assessment. Results: A total of 37 people were recruited, and 30 participants (11 male, 19 female; mean age 30, SD 10.8 years), completed all image-based dietary records. The image rate increased by 0.83 images per day in the standard setting compared to control (P=.23) and increased by 1.78 images per day in the tailored setting compared to control (P≤.001). We found that 13/21 (62%) of participants preferred to use the image-based dietary record versus the text-based dietary record but reported method-specific challenges with each method, particularly the inability to record via an image after a meal had been consumed. Conclusions: Tailored prompting improves adherence to image-based dietary assessment. Future image-based dietary assessment tools should use tailored prompting and offer both image-based and written input options to improve record completeness. %R 10.2196/52074 %U https://mhealth.jmir.org/2024/1/e52074 %U https://doi.org/10.2196/52074 %0 Journal Article %@ 2291-5222 %I %V 12 %N %P e49509 %T mHealth-Based Gamification Interventions Among Men Who Have Sex With Men in the HIV Prevention and Care Continuum: Systematic Review and Meta-Analysis %A Luo,Qianqian %A Zhang,Yue %A Wang,Wei %A Cui,Tianyu %A Li,Tianying %K mHealth %K gamification %K HIV %K men who have sex with men %K meta-analysis %K PRISMA %K mobile health %K Preferred Reporting Items for Systematic Reviews and Meta-Analyses %D 2024 %7 15.4.2024 %9 %J JMIR Mhealth Uhealth %G English %X Background: In the past few years, a burgeoning interest has emerged in applying gamification to promote desired health behaviors. However, little is known about the effectiveness of such applications in the HIV prevention and care continuum among men who have sex with men (MSM). Objective: This study aims to summarize and evaluate research on the effectiveness of gamification on the HIV prevention and care continuum, including HIV-testing promotion; condomless anal sex (CAS) reduction; and uptake of and adherence to pre-exposure prophylaxis (PrEP), postexposure prophylaxis (PEP), and antiretroviral therapy (ART). Methods: We comprehensively searched PubMed, Embase, the Cochrane Library, Web of Science, Scopus, and the Journal of Medical Internet Research and its sister journals for studies published in English and Chinese from inception to January 2024. Eligible studies were included when they used gamified interventions with an active or inactive control group and assessed at least one of the following outcomes: HIV testing; CAS; and uptake of and adherence to PrEP, PEP, and ART. During the meta-analysis, a random-effects model was applied. Two reviewers independently assessed the quality and risk of bias of each included study. Results: The systematic review identified 26 studies, including 10 randomized controlled trials (RCTs). The results indicated that gamified digital interventions had been applied to various HIV outcomes, such as HIV testing, CAS, PrEP uptake and adherence, PEP uptake, and ART adherence. Most of the studies were conducted in the United States (n=19, 73%). The most frequently used game component was gaining points, followed by challenges. The meta-analysis showed gamification interventions could reduce the number of CAS acts at the 3-month follow-up (n=2 RCTs; incidence rate ratio 0.62, 95% CI 0.44-0.88). The meta-analysis also suggested an effective but nonstatistically significant effect of PrEP adherence at the 3-month follow-up (n=3 RCTs; risk ratio 1.16, 95% CI 0.96-1.38) and 6-month follow-up (n=4 RCTs; risk ratio 1.28, 95% CI 0.89-1.84). Only 1 pilot RCT was designed to evaluate the effectiveness of a gamified app in promoting HIV testing and PrEP uptake. No RCT was conducted to evaluate the effect of the gamified digital intervention on PEP uptake and adherence, and ART initiation among MSM. Conclusions: Our findings suggest the short-term effect of gamified digital interventions on lowering the number of CAS acts in MSM. Further well-powered studies are still needed to evaluate the effect of the gamified digital intervention on HIV testing, PrEP uptake, PEP initiation and adherence, and ART initiation in MSM. Trial Registration: PROSPERO CRD42023392193; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=392193 %R 10.2196/49509 %U https://mhealth.jmir.org/2024/1/e49509 %U https://doi.org/10.2196/49509 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e48525 %T The Effects of a Single-Session Virtual Rumination Intervention to Enhance Cognitive Functioning in Veterans With Subjective Cognitive Symptoms: Multimethod Pilot Study %A Austin,Tara %A Smith,Jennifer %A Rabin,Borsika %A Lindamer,Laurie %A Pittman,James %A Justice,Staley %A Twamley,Elizabeth W %A Lantrip,Crystal %+ Research Service, VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, 92161, United States, 1 8585528585, tara.austin@va.gov %K army %K cognition %K cognitive %K emotion regulation %K memory symptoms %K memory %K military %K rumination %K subjective cognitive decline %K telehealth %K telemedicine %K veteran %K worry %D 2024 %7 12.4.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Subjective cognitive concerns (SCCs) entail perceived difficulties in thinking or memory, often reported without substantial objective evidence of cognitive impairment. These concerns are prevalent among individuals with a history of brain injuries, neurological conditions, or chronic illnesses, contributing to both psychological distress and functional limitations. They are increasingly considered to be a risk factor for future objective decline. A considerable number of individuals reporting SCCs also exhibit mental health symptoms, such as a history of trauma, depression, or anxiety. Interventions that address modifiable emotional and cognitive factors related to SCC could improve functioning and quality of life. Therefore, the use of emotion regulation strategies, especially those directed at minimizing rumination, could serve as a promising focus for interventions aimed at mitigating subjective cognitive concerns in veteran populations. Objective: This pilot study explored the feasibility, acceptability, and preliminary efficacy of a brief, 1-session emotion regulation intervention called “Worry Less, Remember More.” The Worry Less, Remember More intervention was designed to reduce rumination and improve subjective cognitive functioning in veterans with subjective cognitive changes (N=15). Methods: We randomized 15 veterans to either the active telehealth condition or waitlist control and completed the intervention. Participants were aged between 31 and 67 (mean 49.5, SD 10.1) years, and the sample was primarily male (12/15, 83%) and White (10/15, 67%). The most common diagnoses were posttraumatic stress disorder and depression. Following the intervention, veteran input was sought through semistructured interviews with a subset of 12 participants, examining feasibility, acceptability, and perceived efficacy. Preliminary efficacy was also measured using pre- and postintervention self-report measures. Results: Veterans reported that this intervention was acceptable, with 92% (11/12) of the sample reporting that they benefited from the intervention and would recommend the intervention to others with similar difficulties. Semistructured interviews revealed difficulties with feasibility, including problems with the remote consenting process, forgetting appointments, and needing additional strategies to remember to consistently use the interventions. The intervention improved self-reported cognitive symptoms on quantitative measures but did not improve self-reported rumination. Conclusions: This pilot study establishes the preliminary feasibility, acceptability, and efficacy of the Worry Less, Remember More intervention for veterans with subjective cognitive symptoms. Future iterations of the intervention may benefit from simplifying the electronic consent process, providing reminders for appointments, and incorporating compensatory cognitive strategies to assist with using the telehealth system, as well as applying the strategies learned in the intervention. While future research is needed with larger samples, including nonveteran populations, the intervention may also be a useful clinical tool to bridge care between neuropsychology clinics and mental health treatment. %M 38608264 %R 10.2196/48525 %U https://formative.jmir.org/2024/1/e48525 %U https://doi.org/10.2196/48525 %U http://www.ncbi.nlm.nih.gov/pubmed/38608264 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e50157 %T Personalized Management of Fatigue in Individuals With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and Long COVID Using a Smart Digital mHealth Solution: Protocol for a Participatory Design Approach %A Dorronzoro-Zubiete,Enrique %A Castro-Marrero,Jesús %A Ropero,Jorge %A Sevillano-Ramos,José Luis %A Dolores Hernández,María %A Sanmartin Sentañes,Ramon %A Alegre-Martin,Jose %A Launois-Obregón,Patricia %A Martin-Garrido,Isabel %A Luque Budia,Asuncion %A Lacalle-Remigio,Juan R %A Béjar Prado,Luis %A Rivera Romero,Octavio %+ Electronic Technology Department, Universidad de Sevilla, avda. Reina Mercedes s/n,, ETSII Informática, Sevilla, 41012, Spain, 34 954554325, orivera@us.es %K acceptability %K myalgic encephalomyelitis/chronic fatigue syndrome %K long COVID %K mHealth %K fatigue %K physical activity %K lifestyle health %K personalized self-management %K user-centered design %D 2024 %7 12.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Fatigue is the most common symptom in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and long COVID, impacting patients’ quality of life; however, there is currently a lack of evidence-based context-aware tools for fatigue self-management in these populations. Objective: This study aimed to (1) address fatigue in ME/CFS and long COVID through the development of digital mobile health solutions for self-management, (2) predict perceived fatigue severity using real-time data, and (3) assess the feasibility and potential benefits of personalized digital mobile health solutions. Methods: The MyFatigue project adopts a patient-centered approach within the participatory health informatics domain. Patient representatives will be actively involved in decision-making processes. This study combines inductive and deductive research approaches, using qualitative studies to generate new knowledge and quantitative methods to test hypotheses regarding the relationship between factors like physical activity, sleep behaviors, and perceived fatigue in ME/CFS and long COVID. Co-design methods will be used to develop a personalized digital solution for fatigue self-management based on the generated knowledge. Finally, a pilot study will evaluate the feasibility, acceptance, and potential benefits of the digital health solution. Results: The MyFatigue project opened to enrollment in November 2023. Initial results are expected to be published by the end of 2024. Conclusions: This study protocol holds the potential to expand understanding, create personalized self-management approaches, engage stakeholders, and ultimately improve the well-being of individuals with ME/CFS and long COVID. International Registered Report Identifier (IRRID): PRR1-10.2196/50157 %M 38608263 %R 10.2196/50157 %U https://www.researchprotocols.org/2024/1/e50157 %U https://doi.org/10.2196/50157 %U http://www.ncbi.nlm.nih.gov/pubmed/38608263 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e53665 %T Evaluation of a Pilot Program to Prevent the Misuse of Prescribed Opioids Among Health Care Workers: Repeated Measures Survey Study %A Hebard,Stephen %A Weaver,GracieLee %A Hansen,William B %A Ruppert,Scarlett %+ Department of Public Health Education, University of North Carolina Greensboro, PO BOX 26170, Greensboro, NC, 27402-6170, United States, 1 336 334 5000, gmweaver@uncg.edu %K health care workers %K opioid misuse %K pain management %K prescription opioids %K prevention %K substance abuse %K substance use %K workers %D 2024 %7 12.4.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Overprescription of opioids has led to increased misuse of opioids, resulting in higher rates of overdose. The workplace can play a vital role in an individual’s intentions to misuse prescription opioids with injured workers being prescribed opioids, at a rate 3 times the national average. For example, health care workers are at risk for injuries, opioid dispensing, and diversion. Intervening within a context that may contribute to risks for opioid misuse while targeting individual psychosocial factors may be a useful complement to interventions at policy and prescribing levels. Objective: This pilot study assessed the effects of a mobile-friendly opioid misuse intervention prototype tailored for health care workers using the preparation phase of a multiphase optimization strategy design. Methods: A total of 33 health care practitioners participated in the pilot intervention, which included 10 brief web-based lessons aimed at impacting psychosocial measures that underlie opioid misuse. The lesson topics included: addiction beliefs, addiction control, Centers for Disease Control and Prevention guidelines and recommendations, beliefs about patient-provider relationships and communication, control in communicating with providers, beliefs about self-monitoring pain and side effects, control in self-monitoring pain and side effects, diversion and disposal beliefs, diversion and disposal control, and a conclusion lesson. Using a treatment-only design, pretest and posttest surveys were collected. A general linear repeated measures ANOVA was used to assess mean differences from pretest to posttest. Descriptive statistics were used to assess participant feedback about the intervention. Results: After completing the intervention, participants showed significant mean changes with increases in knowledge of opioids (+0.459; P<.001), less favorable attitudes toward opioids (–1.081; P=.001), more positive beliefs about communication with providers (+0.205; P=.01), more positive beliefs about pain management control (+0.969; P<.001), and increased intentions to avoid opioid use (+0.212; P=.03). Of the 33 practitioners who completed the program, most felt positive about the information presented, and almost 70% (23/33) agreed or strongly agreed that other workers in the industry should complete a program like this. Conclusions: While attempts to address the opioid crisis have been made through public health policies and prescribing initiatives, opioid misuse continues to rise. Certain industries place workers at greater risk for injury and opioid dispensing, making interventions that target workers in these industries of particular importance. Results from this pilot study show positive impacts on knowledge, attitudes, and beliefs about communicating with providers and pain management control, as well as intentions to avoid opioid misuse. However, the dropout rate and small sample size are severe limitations, and the results lack generalizability. Results will be used to inform program revisions and future optimization trials, with the intention of providing insight for future intervention development and evaluation of mobile-friendly eHealth interventions for employees. %M 38607664 %R 10.2196/53665 %U https://formative.jmir.org/2024/1/e53665 %U https://doi.org/10.2196/53665 %U http://www.ncbi.nlm.nih.gov/pubmed/38607664 %0 Journal Article %@ 2561-6722 %I %V 7 %N %P e48478 %T Evaluation of Parents’ Use of a Child Health Care Information App and Their Health Literacy: Cross-Sectional Study %A Sakamoto,Masahiko %A Ishikawa,Hirono %A Suzuki,Asuka %K health literacy %K European Health Literacy Survey Questionnaire %K HLS-EU-Q47 %K child %K preschool %K parent education %K health care knowledge %K apps %K digital media %K emergency room visit %K mobile phone %D 2024 %7 11.4.2024 %9 %J JMIR Pediatr Parent %G English %X Background: Recently, digital media, including internet websites and smartphone apps, have become popular resources for parents in searching for child health care information. Higher health literacy among parents in obtaining adequate health care information and making proper decisions may lead to improved child health outcomes and a reduction in the burden on health care professionals. However, few studies have examined the association between the provision of child health care information apps and parents’ health literacy. Objective: This study aims to evaluate whether parents’ use of an app that provides child health care information is associated with their health care knowledge, their health literacy, and emergency room visits for their children. Methods: Participants were recruited during checkups for their 1.5-year-old children at health centers within Saku City in 2022. Parents who agreed to participate were included in this study; individuals were excluded if they were not the mother or father of the child or did not have a smartphone. Participants were asked if they had used the Oshiete-Doctor app, which was distributed by Saku City free of charge to improve the home nursing skills of parents and guardians. Sociodemographic data of parents and children, data on health care knowledge about children, data on the frequency of emergency room visits in the past 6 months, and health literacy scores (HLSs) of parents (measured with the HLS-EU-Q47 [European Health Literacy Survey Questionnaire]) were collected from participants in this cross-sectional survey. Univariable and multivariable analyses were conducted to examine the associations of app use with health care knowledge, health literacy, and emergency room visits. Results: In total, 251 respondents completed the survey (response rate: 251/267, 94%). Although the proportion of health care workers was significantly higher among app users than among non–app users (P=.005), no other participant attributes were significantly associated with the use of the app. The proportions of participants with higher health care knowledge and participants with higher total HLSs were significantly higher among app users than among non–app users (P=.001 and P=.003, respectively). After adjusting for potentially confounding covariates, these proportions were still significantly higher among app users than among non–app users (P=.02 and P=.007, respectively). Emergency room visits were significantly more frequent among app users than among non–app users (P=.007) in the univariable analysis, but the association was not significant (P=.07) after adjusting for sociodemographic variables. Conclusions: This study showed a significant association between parents’ use of a child health care information app and higher child health care knowledge and health literacy. The use of the app may lead to more appropriate health decisions and behaviors in children’s health care. Future studies are needed to evaluate the association between app use and emergency room visits. %R 10.2196/48478 %U https://pediatrics.jmir.org/2024/1/e48478 %U https://doi.org/10.2196/48478 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e49751 %T Users' Acceptability and Perceived Efficacy of mHealth for Opioid Use Disorder: Scoping Review %A Lyzwinski,Lynnette Nathalie %A Elgendi,Mohamed %A Menon,Carlo %+ Menrva Research Group, School of Mechatronics Systems Engineering and Engineering Science, Simon Fraser University, 250-13450 102 Avenue, Metro Vancouver, Vancouver, BC, V3T 0A3, Canada, 1 778 302 1151, lnl2@sfu.ca %K acceptability %K addict %K addiction %K addictions %K app %K app-based %K application %K applications %K apps %K barrier %K barriers %K challenge %K challenges %K messaging %K mHealth %K mobile health %K monitoring %K opioid %K opioids %K overdose %K overdosing %K pharmacology %K review methodology %K review methods %K scoping %K sensor %K sensors %K SMS %K substance abuse %K substance use %K text message %K wearable technology %K wearable %K wearables %D 2024 %7 11.4.2024 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: The opioid crisis continues to pose significant challenges to global public health, necessitating the development of novel interventions to support individuals in managing their substance use and preventing overdose-related deaths. Mobile health (mHealth), as a promising platform for addressing opioid use disorder, requires a comprehensive understanding of user perspectives to minimize barriers to care and optimize the benefits of mHealth interventions. Objective: This study aims to synthesize qualitative insights into opioid users’ acceptability and perceived efficacy of mHealth and wearable technologies for opioid use disorder. Methods: A scoping review of PubMed (MEDLINE) and Google Scholar databases was conducted to identify research on opioid user perspectives concerning mHealth-assisted interventions, including wearable sensors, SMS text messaging, and app-based technology. Results: Overall, users demonstrate a high willingness to engage with mHealth interventions to prevent overdose-related deaths and manage opioid use. Users perceive mHealth as an opportunity to access care and desire the involvement of trusted health care professionals in these technologies. User comfort with wearing opioid sensors emerged as a significant factor. Personally tailored content, social support, and encouragement are preferred by users. Privacy concerns and limited access to technology pose barriers to care. Conclusions: To maximize benefits and minimize risks for users, it is crucial to implement robust privacy measures, provide comprehensive user training, integrate behavior change techniques, offer professional and peer support, deliver tailored messages, incorporate behavior change theories, assess readiness for change, design stigma-reducing apps, use visual elements, and conduct user-focused research for effective opioid management in mHealth interventions. mHealth demonstrates considerable potential as a tool for addressing opioid use disorder and preventing overdose-related deaths, given the high acceptability and perceived benefits reported by users. %M 38602751 %R 10.2196/49751 %U https://mhealth.jmir.org/2024/1/e49751 %U https://doi.org/10.2196/49751 %U http://www.ncbi.nlm.nih.gov/pubmed/38602751 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e57226 %T Smartphone App–Delivered Mindfulness-Based Intervention for Mild Traumatic Brain Injury in Adolescents: Protocol for a Feasibility Randomized Controlled Trial %A Ledoux,Andrée-Anne %A Zemek,Roger %A Cairncross,Molly %A Silverberg,Noah %A Sicard,Veronik %A Barrowman,Nicholas %A Goldfield,Gary %A Gray,Clare %A Harris,Ashley D %A Jaworska,Natalia %A Reed,Nick %A Saab,Bechara J %A Smith,Andra %A Walker,Lisa %+ Children's Hospital of Eastern Ontario Research Institute, 401 Smyth Road, Ottawa, ON, K1H 8L1, Canada, 1 6137377600 ext 4104, aledoux@cheo.on.ca %K pediatric %K concussion %K persisting symptoms after concussion %K mindfulness %K randomized controlled trial %K feasibility RCT %K psychological intervention %K youth %K digital therapeutics %K eHealth %K mobile health %K mHealth %K mobile phone %D 2024 %7 11.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Concussion in children and adolescents is a significant public health concern, with 30% to 35% of patients at risk for prolonged emotional, cognitive, sleep, or physical symptoms. These symptoms negatively impact a child’s quality of life while interfering with their participation in important neurodevelopmental activities such as schoolwork, socializing, and sports. Early psychological intervention following a concussion may improve the ability to regulate emotions and adapt to postinjury symptoms, resulting in the greater acceptance of change; reduced stress; and recovery of somatic, emotional, and cognitive symptoms. Objective: The primary objective of this study is to assess the feasibility of conducting a parallel-group (1:1) randomized controlled trial (RCT) to evaluate a digital therapeutics (DTx) mindfulness-based intervention (MBI) in adolescents aged 12 to <18 years. The attention-matched comparator intervention (a math game also used in previous RCTs) will be delivered on the same DTx platform. Both groups will be provided with the standard of care guidelines. The secondary objective is to examine intervention trends for quality of life; resilience; self-efficacy; cognition such as attention, working memory, and executive functioning; symptom burden; and anxiety and depression scores at 4 weeks after concussion, which will inform a more definitive RCT. A subsample will be used to examine whether those randomized to the experimental intervention group have different brain-based imaging patterns compared with those randomized to the control group. Methods: This study is a double-blind Health Canada–regulated trial. A total of 70 participants will be enrolled within 7 days of concussion and randomly assigned to receive the 4-week DTx MBI (experimental group) or comparator intervention. Feasibility will be assessed based on the recruitment rate, treatment adherence to both interventions, and retention. All outcome measures will be evaluated before the intervention (within 7 days after injury) and at 1, 2, and 4 weeks after the injury. A subset of 60 participants will undergo magnetic resonance imaging within 72 hours and at 4 weeks after recruitment to identify the neurophysiological mechanisms underlying the potential benefits from MBI training in adolescents following a concussion. Results: The recruitment began in October 2022, and the data collection is expected to be completed by September 2024. Data collection and management is still in progress; therefore, data analysis is yet to be conducted. Conclusions: This trial will confirm the feasibility and resolve uncertainties to inform a future definitive multicenter efficacy RCT. If proven effective, a smartphone-based MBI has the potential to be an accessible and low-risk preventive treatment for youth at risk of experiencing prolonged postconcussion symptoms and complications. Trial Registration: ClinicalTrials.gov NCT05105802; https://classic.clinicaltrials.gov/ct2/show/NCT05105802 International Registered Report Identifier (IRRID): DERR1-10.2196/57226 %M 38602770 %R 10.2196/57226 %U https://www.researchprotocols.org/2024/1/e57226 %U https://doi.org/10.2196/57226 %U http://www.ncbi.nlm.nih.gov/pubmed/38602770 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e52118 %T Effectiveness of a Web-Based Individual Coping and Alcohol Intervention Program for Children of Parents With Alcohol Use Problems: Randomized Controlled Trial %A Wall,Håkan %A Hansson,Helena %A Zetterlind,Ulla %A Kvillemo,Pia %A Elgán,Tobias H %+ Stockholm Prevents Alcohol and Drug Problems, Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Norra Stationsgatan 69, Stockholm, 11364, Sweden, 46 700011003, tobias.elgan@ki.se %K adolescent %K adolescents %K alcoholic %K alcoholics %K CBT %K children of impaired parents %K cognitive behavioral therapy %K coping %K digital intervention %K mental health %K randomized controlled trial %K RCT %K self-management %K substance abuse %K substance use %K therapist %K web-based intervention %K youth %D 2024 %7 10.4.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Children whose parents have alcohol use problems are at an increased risk of several negative consequences, such as poor school performance, an earlier onset of substance use, and poor mental health. Many would benefit from support programs, but the figures reveal that only a small proportion is reached by existing support. Digital interventions can provide readily accessible support and potentially reach a large number of children. Research on digital interventions aimed at this target group is scarce. We have developed a novel digital therapist-assisted self-management intervention targeting adolescents whose parents had alcohol use problems. This program aims to strengthen coping behaviors, improve mental health, and decrease alcohol consumption in adolescents. Objective: This study aims to examine the effectiveness of a novel web-based therapist-assisted self-management intervention for adolescents whose parents have alcohol use problems. Methods: Participants were recruited on the internet from social media and websites containing health-related information about adolescents. Possible participants were screened using the short version of the Children of Alcoholics Screening Test-6. Eligible participants were randomly allocated to either the intervention group (n=101) or the waitlist control group (n=103), and they were unblinded to the condition. The assessments, all self-assessed, consisted of a baseline and 2 follow-ups after 2 and 6 months. The primary outcome was the Coping With Parents Abuse Questionnaire (CPAQ), and secondary outcomes were the Center for Epidemiological Studies Depression Scale, Alcohol Use Disorders Identification Test (AUDIT-C), and Ladder of Life (LoL). Results: For the primary outcome, CPAQ, a small but inconclusive treatment effect was observed (Cohen d=–0.05 at both follow-up time points). The intervention group scored 38% and 46% lower than the control group on the continuous part of the AUDIT-C at the 2- and 6-month follow-up, respectively. All other between-group comparisons were inconclusive at either follow-up time point. Adherence was low, as only 24% (24/101) of the participants in the intervention group completed the intervention. Conclusions: The findings were inconclusive for the primary outcome but demonstrate that a digital therapist-assisted self-management intervention may contribute to a reduction in alcohol consumption. These results highlight the potential for digital interventions to reach a vulnerable, hard-to-reach group of adolescents but underscore the need to develop more engaging support interventions to increase adherence. Trial Registration: ISRCTN Registry ISRCTN41545712; https://www.isrctn.com/ISRCTN41545712?q=ISRCTN41545712 International Registered Report Identifier (IRRID): RR2-10.1186/1471-2458-12-35 %M 38598286 %R 10.2196/52118 %U https://www.jmir.org/2024/1/e52118 %U https://doi.org/10.2196/52118 %U http://www.ncbi.nlm.nih.gov/pubmed/38598286 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 9 %N %P e55165 %T Moderating Effect of Depression on Glycemic Control in an eHealth Intervention Among Black Youth With Type 1 Diabetes: Findings From a Multicenter Randomized Controlled Trial %A Ellis,Deborah %A Carcone,April Idalski %A Templin,Thomas %A Evans,Meredyth %A Weissberg-Benchell,Jill %A Buggs-Saxton,Colleen %A Boucher-Berry,Claudia %A Miller,Jennifer L %A Drossos,Tina %A Dekelbab,M Bassem %+ Department of Family Medicine and Public Health Sciences, Wayne State University School of Medicine, IBio Behavioral Health, 6135 Woodward Avenue, Detroit, MI, 48202, United States, 1 3135771055, dellis@med.wayne.edu %K adolescents %K black %K depression %K eHealth %K family intervention %K randomized clinical trial %K randomized controlled trial %K T1D %K type 1 diabetes %D 2024 %7 9.4.2024 %9 Original Paper %J JMIR Diabetes %G English %X Background: Black adolescents with type 1 diabetes (T1D) are at increased risk for suboptimal diabetes health outcomes; however, evidence-based interventions for this population are lacking. Depression affects a high percentage of youth with T1D and increases the likelihood of health problems associated with diabetes. Objective: Our aim was to test whether baseline levels of depression moderate the effects of a brief eHealth parenting intervention delivered to caregivers of young Black adolescents with T1D on youths’ glycemic control. Methods: We conducted a multicenter randomized controlled trial at 7 pediatric diabetes clinics located in 2 large US cities. Participants (N=149) were allocated to either the intervention group or a standard medical care control group. Up to 3 intervention sessions were delivered on a tablet computer during diabetes clinic visits over a 12-month period. Results: In a linear mixed effects regression model, planned contrasts did not show significant reductions in hemoglobin A1c (HbA1c) for intervention adolescents compared to controls. However, adolescents with higher baseline levels of depressive symptoms who received the intervention had significantly greater improvements in HbA1c levels at 6-month follow-up (0.94%; P=.01) and 18-month follow-up (1.42%; P=.002) than those with lower levels of depression. Within the intervention group, adolescents had a statistically significant reduction in HbA1c levels from baseline at 6-month and 18-month follow-up. Conclusions: A brief, culturally tailored eHealth parenting intervention improved health outcomes among Black adolescents with T1D and depressive symptoms. Trial Registration: ClinicalTrials.gov NCT03168867; https://clinicaltrials.gov/study/NCT03168867 %M 38593428 %R 10.2196/55165 %U https://diabetes.jmir.org/2024/1/e55165 %U https://doi.org/10.2196/55165 %U http://www.ncbi.nlm.nih.gov/pubmed/38593428 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e52558 %T Nudges and Prompts Increase Engagement in Self-Guided Digital Health Treatment for Depression and Anxiety: Results From a 3-Arm Randomized Controlled Trial %A van Mierlo,Trevor %A Rondina,Renante %A Fournier,Rachel %+ Evolution Health, 206-90 Eglinton Avenue East, Toronto, ON, M4P 2Y3, Canada, 1 4166448476, tvanmierlo@evolutionhealth.care %K behavioral economics %K digital health %K attrition %K engagement %K nudges %K depression %K anxiety %K mood disorders %D 2024 %7 9.4.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Accessible and effective approaches to mental health treatment are important because of common barriers such as cost, stigma, and provider shortage. The effectiveness of self-guided treatment is well established, and its use has intensified because of the COVID-19 pandemic. Engagement remains important as dose-response relationships have been observed. Platforms such as Facebook (Meta Platform, Inc), LinkedIn (Microsoft Corp), and X Corp (formerly known as Twitter, Inc) use principles of behavioral economics to increase engagement. We hypothesized that similar concepts would increase engagement in self-guided digital health. Objective: This 3-arm randomized controlled trial aimed to test whether members of 2 digital self-health courses for anxiety and depression would engage with behavioral nudges and prompts. Our primary hypothesis was that members would click on 2 features: tips and a to-do checklist. Our secondary hypothesis was that members would prefer to engage with directive tips in arm 2 versus social proof and present bias tips in arm 3. Our tertiary hypothesis was that rotating tips and a to-do checklist would increase completion rates. The results of this study will form a baseline for future artificial intelligence–directed research. Methods: Overall, 13,224 new members registered between November 2021 and May 2022 for Evolution Health’s self-guided treatment courses for anxiety and depression. The control arm featured a member home page without nudges or prompts. Arm 2 featured a home page with a tip-of-the-day section. Arm 3 featured a home page with a tip-of-the-day section and a to-do checklist. The research protocol for this study was published in JMIR Research Protocols on August 15, 2022. Results: Arm 3 had significantly younger members (F2,4564=40.97; P<.001) and significantly more female members (χ24=92.2; P<.001) than the other 2 arms. Control arm members (1788/13,224, 13.52%) completed an average of 1.5 course components. Arm 2 members (865/13,224, 6.54%) clicked on 5% of tips and completed an average of 1.8 course components. Arm 3 members (1914/13,224, 14.47%) clicked on 5% of tips, completed 2.7 of 8 to-do checklist items, and completed an average of 2.11 course components. Completion rates in arm 2 were greater than those in arm 1 (z score=3.37; P<.001), and completion rates in arm 3 were greater than those in arm 1 (z score=12.23; P<.001). Engagement in all 8 components in arm 3 was higher than that in arm 2 (z score=1.31; P<.001). Conclusions: Members engaged with behavioral nudges and prompts. The results of this study may be important because efficacy is related to increased engagement. Due to its novel approach, the outcomes of this study should be interpreted with caution and used as a guideline for future research in this nascent field. International Registered Report Identifier (IRRID): RR2-10.2196/37231 %M 38592752 %R 10.2196/52558 %U https://formative.jmir.org/2024/1/e52558 %U https://doi.org/10.2196/52558 %U http://www.ncbi.nlm.nih.gov/pubmed/38592752 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e53998 %T Feasibility, Acceptability, and Preliminary Efficacy of a Smartphone App–Led Cognitive Behavioral Therapy for Depression Under Therapist Supervision: Open Trial %A Wilhelm,Sabine %A Bernstein,Emily E %A Bentley,Kate H %A Snorrason,Ivar %A Hoeppner,Susanne S %A Klare,Dalton %A Greenberg,Jennifer L %A Weingarden,Hilary %A McCoy,Thomas H %A Harrison,Oliver %+ Massachusetts General Hospital, Harvard Medical School, 185 Cambridge Street, Suite 2000, Boston, MA, 02114, United States, 1 617 724 6146, swilhelm@mgh.harvard.edu %K depressive disorder %K depressive %K depression %K open trial %K open trials %K single arm %K smartphone %K cognitive behavioral therapy %K cognitive behavioural therapy %K CBT %K psychotherapy %K psychoeducation %K digital health %K mobile applications %K mHealth %K mobile health %K app %K apps %K application %K applications %K psychiatry %K psychiatric %K feasibility %K acceptability %K usability %K satisfaction %K user experience %K mental %D 2024 %7 9.4.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Major depressive disorder affects approximately 1 in 5 adults during their lifetime and is the leading cause of disability worldwide. Yet, a minority receive adequate treatment due to person-level (eg, geographical distance to providers) and systems-level (eg, shortage of trained providers) barriers. Digital tools could improve this treatment gap by reducing the time and frequency of therapy sessions needed for effective treatment through the provision of flexible, automated support. Objective: This study aimed to examine the feasibility, acceptability, and preliminary clinical effect of Mindset for Depression, a deployment-ready 8-week smartphone-based cognitive behavioral therapy (CBT) supported by brief teletherapy appointments with a therapist. Methods: This 8-week, single-arm open trial tested the Mindset for Depression app when combined with 8 brief (16-25 minutes) video conferencing visits with a licensed doctoral-level CBT therapist (n=28 participants). The app offers flexible, accessible psychoeducation, CBT skills practice, and support to patients as well as clinician guidance to promote sustained engagement, monitor safety, and tailor treatment to individual patient needs. To increase accessibility and thus generalizability, all study procedures were conducted remotely. Feasibility and acceptability were assessed via attrition, patient expectations and feedback, and treatment utilization. The primary clinical outcome measure was the clinician-rated Hamilton Depression Rating Scale, administered at pretreatment, midpoint, and posttreatment. Secondary measures of functional impairment and quality of life as well as maintenance of gains (3-month follow-up) were also collected. Results: Treatment credibility (week 4), expectancy (week 4), and satisfaction (week 8) were moderate to high, and attrition was low (n=2, 7%). Participants self-reported using the app or practicing (either on or off the app) the CBT skills taught in the app for a median of 50 (IQR 30-60; week 4) or 60 (IQR 30-90; week 8) minutes per week; participants accessed the app on an average 36.8 (SD 10.0) days and completed a median of 7 of 8 (IQR 6-8) steps by the week 8 assessment. The app was rated positively across domains of engagement, functionality, aesthetics, and information. Participants’ depression severity scores decreased from an average Hamilton Depression Rating Scale score indicating moderate depression (mean 19.1, SD 5.0) at baseline to a week 8 mean score indicating mild depression (mean 10.8, SD 6.1; d=1.47; P<.001). Improvement was also observed for functional impairment and quality of life. Gains were maintained at 3-month follow-up. Conclusions: The results show that Mindset for Depression is a feasible and acceptable treatment option for individuals with major depressive disorder. This smartphone-led treatment holds promise to be an efficacious, scalable, and cost-effective treatment option. The next steps include testing Mindset for Depression in a fully powered randomized controlled trial and real-world clinical settings. Trial Registration: ClinicalTrials.gov NCT05386329; https://clinicaltrials.gov/study/NCT05386329?term=NCT05386329 %M 38592771 %R 10.2196/53998 %U https://mental.jmir.org/2024/1/e53998 %U https://doi.org/10.2196/53998 %U http://www.ncbi.nlm.nih.gov/pubmed/38592771 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 10 %N %P e53117 %T Evaluation of the e–Mental Health Intervention Make It Training From Patients' Perspectives: Qualitative Analysis Within the Reduct Trial %A Krakowczyk,Julia Barbara %A Truijens,Femke %A Teufel,Martin %A Lalgi,Tania %A Heinen,Jana %A Schug,Caterina %A Erim,Yesim %A Pantförder,Michael %A Graf,Johanna %A Bäuerle,Alexander %+ Clinic for Psychosomatic Medicine and Psychotherapy, LVR-University Hospital Essen, University of Duisburg-Essen, Virchowstraße 174, Essen, Germany, 49 201438755216, julia.krakowczyk@uni-due.de %K psycho-oncology %K eHealth %K digital health %K cancer %K Reduct trial %K oncology %D 2024 %7 9.4.2024 %9 Original Paper %J JMIR Cancer %G English %X Background: Make It Training is an e–mental health intervention designed for individuals with cancer that aims to reduce psychological distress and improve disease-related coping and quality of life. Objective: This study evaluated the experienced usefulness and usability of the web-based Make It Training intervention using a qualitative approach. Methods: In this study, semistructured interviews were conducted with participants at different cancer stages and with different cancer entities. All participants had previously taken part in the Reduct trial, a randomized controlled trial that assessed the efficacy of the Make It Training intervention. The data were coded deductively by 2 independent researchers and analyzed iteratively using thematic codebook analysis. Results: Analysis of experienced usefulness resulted in 4 themes (developing coping strategies to reduce psychological distress, improvement in quality of life, Make It Training vs traditional psychotherapy, and integration into daily life) with 11 subthemes. Analysis of experienced usability resulted in 3 themes (efficiency and accessibility, user-friendliness, and recommendations to design the Make It Training intervention to be more appealing) with 6 subthemes. Make It Training was evaluated as a user-friendly intervention helpful for developing functional coping strategies to reduce psychological distress and improve quality of life. The consensus regarding Make It Training was that it was described as a daily companion that integrates well into daily life and that it has the potential to be routinely implemented within oncological health care either as a stand-alone intervention or in addition to psychotherapy. Conclusions: e–Mental health interventions such as Make It Training can target both the prevention of mental health issues and health promotion. Moreover, they offer a cost-efficient and low-threshold option to receive psycho-oncological support. %M 38592764 %R 10.2196/53117 %U https://cancer.jmir.org/2024/1/e53117 %U https://doi.org/10.2196/53117 %U http://www.ncbi.nlm.nih.gov/pubmed/38592764 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e54658 %T Understanding Adolescents’ Experiences With Menstrual Pain to Inform the User-Centered Design of a Mindfulness-Based App: Mixed Methods Investigation Study %A Gagnon,Michelle M %A Brilz,Alexandra R %A Alberts,Nicole M %A Gordon,Jennifer L %A Risling,Tracie L %A Stinson,Jennifer N %+ Department of Psychology and Health Studies, University of Saskatchewan, 9 Campus Drive, Arts 154, Saskatoon, SK, S7N5A2, Canada, 1 306 966 2052, michelle.gagnon@usask.ca %K adolescent health %K endometriosis %K pain management, biopsychosocial %K women’s health %K dysmenorrhea %K thematic analysis %K mHealth %K mobile health %K app %K apps %K applications %K applications %K attitude %K attitudes %K opinion %K opinion %K perception %K perceptions %K perspective %K perspectives %K interest %K intent %K intention %K survey %K surveys %K focus group %K focus groups %K content analysis %K mindfulness %K meditation %K menstrual %K menstruation %K experience %K experiences %K pain %K youth %K adolescent %K adolescents %K teen %K teens %K teenager %K teenagers %D 2024 %7 8.4.2024 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Digital interventions are increasingly popular for the provision of nonpharmacological pain interventions, but few exist for adolescents with menstrual pain. User-centered design involves incorporating users across phases of digital health intervention design, development, and implementation and leads to improved user engagement and outcomes. A needs assessment is the first step of this approach. Objective: The goal of this study was to conduct a needs assessment to understand menstrual pain management needs and preferences and mindfulness experiences, preferences, and knowledge of adolescents with menstrual pain to inform the future development of an app for managing menstrual pain. Methods: We used an explanatory sequential mixed method design that included a survey followed by focus groups. Adolescents aged 13-17 years completed a survey (n=111) and participated in focus groups (n=16). Data were analyzed using descriptive statistics and thematic content analysis and synthesized to provide specific recommendations based on adolescent responses. Results: Adolescents (n=111) who completed the survey reported a moderate understanding of mindfulness and menstrual pain. Over three-quarters (n=87, 78%) of participants practiced some form of mindfulness and 87% (n=97) of survey participants used nonpharmacological pain management strategies. Teens had a moderate perception that mindfulness could help their menstrual pain (mean 4.51/10, SD 2.45, with higher scores suggesting more interest). Themes were generated related to mindfulness experiences, menstrual pain knowledge and experiences, and app functionality. These themes underscored adolescents’ need for continued support and flexible access to mindfulness activities; their awareness of multiple influences to pain, with potential for further education in this area; and the need for menstrual pain–specific content, along with content relevant to typical day-to-day experiences of adolescents. Conclusions: Adolescents with menstrual pain have an interest in using a mindfulness app for pain but have unique needs that need to be addressed to ensure app engagement and relevance for this population. Concrete recommendations for future app development are provided. %M 38587886 %R 10.2196/54658 %U https://pediatrics.jmir.org/2024/1/e54658 %U https://doi.org/10.2196/54658 %U http://www.ncbi.nlm.nih.gov/pubmed/38587886 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e53006 %T Development of a Health Behavioral Digital Intervention for Patients With Hypertension Based on an Intelligent Health Promotion System and WeChat: Randomized Controlled Trial %A Sun,Ting %A Xu,Xuejie %A Ding,Zenghui %A Xie,Hui %A Ma,Linlin %A Zhang,Jing %A Xia,Yuxin %A Zhang,Guoli %A Ma,Zuchang %+ Hefei Institutes of Physical Science, Chinese Academy of Sciences, #350 Shushan Lake Road, Shushan District, Hefei, 230031, China, 86 13956984669, ZCMa121@126.com %K adherence %K hypertension %K health behavior %K mHealth %K digital health %D 2024 %7 5.4.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The effectiveness of timely medication, physical activity (PA), a healthy diet, and blood pressure (BP) monitoring for promoting health outcomes and behavioral changes among patients with hypertension is supported by a substantial amount of literature, with “adherence” playing a pivotal role. Nevertheless, there is a lack of consistent evidence regarding whether digital interventions can improve adherence to healthy behaviors among individuals with hypertension. Objective: The aim was to develop a health behavioral digital intervention for hypertensive patients (HBDIHP) based on an intelligent health promotion system and WeChat following the behavior change wheel (BCW) theory and digital micro-intervention care (DMIC) model and assess its efficacy in controlling BP and improving healthy behavior adherence. Methods: A 2-arm, randomized trial design was used. We randomly assigned 68 individuals aged >60 years with hypertension in a 1:1 ratio to either the control or experimental group. The digital intervention was established through the following steps: (1) developing digital health education materials focused on adherence to exercise prescriptions, Dietary Approaches to Stop Hypertension (DASH), prescribed medication, and monitoring of BP; (2) using the BCW theory to select behavior change techniques; (3) constructing the intervention's logic following the guidelines of the DMIC model; (4) creating an intervention manual including the aforementioned elements. Prior to the experiment, participants underwent physical examinations at the community health service center's intelligent health cabin and received intelligent personalized health recommendations. The experimental group underwent a 12-week behavior intervention via WeChat, while the control group received routine health education and a self-management manual. The primary outcomes included BP and adherence indicators. Data analysis was performed using SPSS, with independent sample t tests, chi-square tests, paired t tests, and McNemar tests. A P value <.05 was considered statistically significant. Results: The final analysis included 54 participants with a mean age of 67.24 (SD 4.19) years (n=23 experimental group, n=31 control group). The experimental group had improvements in systolic BP (–7.36 mm Hg, P=.002), exercise time (856.35 metabolic equivalent [MET]-min/week, P<.001), medication adherence (0.56, P=.001), BP monitoring frequency (P=.02), and learning performance (3.23, P<.001). Both groups experienced weight reduction (experimental: 1.2 kg, P=.002; control: 1.11 kg, P=.009) after the intervention. The diet types and quantities for both groups (P<.001) as well as the subendocardial viability ratio (0.16, P=.01) showed significant improvement. However, there were no statistically significant changes in other health outcomes. Conclusions: The observations suggest our program may have enhanced specific health outcomes and adherence to health behaviors in older adults with hypertension. However, a longer-term, larger-scale trial is necessary to validate the effectiveness. Trial Registration: Chinese Clinical Trial Registry ChiCTR2200062643; https://www.chictr.org.cn/showprojEN.html?proj=172782 International Registered Report Identifier (IRRID): RR2-10.2196/46883 %M 38578692 %R 10.2196/53006 %U https://mhealth.jmir.org/2024/1/e53006 %U https://doi.org/10.2196/53006 %U http://www.ncbi.nlm.nih.gov/pubmed/38578692 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e51558 %T Assessing the Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity: Randomized Controlled Trial %A Anastasiadou,Dimitra %A Herrero,Pol %A Garcia-Royo,Paula %A Vázquez-De Sebastián,Julia %A Slater,Mel %A Spanlang,Bernhard %A Álvarez de la Campa,Elena %A Ciudin,Andreea %A Comas,Marta %A Ramos-Quiroga,Josep Antoni %A Lusilla-Palacios,Pilar %+ Department of Clinical and Health Psychology, Universitat Autònoma de Barcelona, Cerdanyola del Vallès, Barcelona, Bellaterra, Barcelona, 08193, Spain, 34 935813854, dimitra.anastasiadou@uab.cat %K obesity %K virtual reality %K psychological treatment %K embodiment %K motivational interviewing %K self-conversation %D 2024 %7 5.4.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Virtual reality (VR) interventions, based on cognitive behavioral therapy principles, have been proven effective as complementary tools in managing obesity and have been associated with promoting healthy behaviors and addressing body image concerns. However, they have not fully addressed certain underlying causes of obesity, such as a lack of motivation to change, low self-efficacy, and the impact of weight stigma interiorization, which often impede treatment adherence and long-term lifestyle habit changes. To tackle these concerns, this study introduces the VR self-counseling paradigm, which incorporates embodiment and body-swapping techniques, along with motivational strategies, to help people living with obesity effectively address some of the root causes of their condition. Objective: This study aims to assess the clinical efficacy of ConVRself (Virtual Reality self-talk), a VR platform that allows participants to engage in motivational self-conversations. Methods: A randomized controlled trial was conducted with 68 participants from the bariatric surgery waiting list from the obesity unit of the Vall d’Hebron University Hospital in Barcelona, Spain. Participants were assigned to 1 of 3 groups: a control group (CG), which only received treatment as usual from the obesity unit; experimental group 1 (EG1), which, after intensive motivational interviewing training, engaged in 4 sessions of VR-based self-conversations with ConVRself, and underwent embodiment and body-swapping techniques; and experimental group 2 (EG2), which engaged in 4 VR-based sessions led by a virtual counselor with a prerecorded discourse, and only underwent the embodiment technique. In the case of both EG1 and EG2, the VR interventions were assisted by a clinical researcher. Readiness to change habits, eating habits, and psychological variables, as well as adherence and satisfaction with ConVRself were measured at baseline, after the intervention, 1 week after the intervention, and 4 weeks after the intervention. Results: Regarding the primary outcomes, EG1 (24/68, 35%) and EG2 (22/68, 32%) showed significant improvements in confidence to lose weight compared to the CG (22/68, 32%) at all assessment points (β=−.16; P=.02). Similarly, EG1 demonstrated a significant increase after the intervention in readiness to exercise more compared to the CG (β=−.17; P=.03). Regarding the secondary outcomes, EG1 participants showed a significant reduction in uncontrolled eating (β=.71; P=.01) and emotional eating (β=.29; P=.03) compared to the CG participants, as well as in their anxiety levels compared to EG2 and CG participants (β=.65; P=.01). In addition, participants from the experimental groups reported high adherence and satisfaction with the VR platform (EG1: mean 59.82, SD 4.00; EG2: mean 58.43, SD 5.22; d=0.30, 95% CI −0.30 to 0.89). Conclusions: This study revealed that using VR self-conversations, based on motivational interviewing principles, may have benefits in helping people with obesity to enhance their readiness to change habits and self-efficacy, as well as reduce dysfunctional eating behaviors and anxiety. Trial Registration: ClinicalTrials.gov NCT05094557; https://www.clinicaltrials.gov/study/NCT05094557 %M 38578667 %R 10.2196/51558 %U https://www.jmir.org/2024/1/e51558 %U https://doi.org/10.2196/51558 %U http://www.ncbi.nlm.nih.gov/pubmed/38578667 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e53841 %T Acceptability of a Self-Guided Lifestyle Intervention Among Young Men: Mixed Methods Analysis of Pilot Findings %A Reading,Jean Miki %A Crane,Melissa M %A Guan,Justin %A Jackman,Ronston %A Thomson,Maria D %A LaRose,Jessica Gokee %+ Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, 680 N Lake Shore Dr, Chicago, IL, 60611, United States, 1 3125034870, jean.reading@northwestern.edu %K digital health %K gender %K weight loss %K health behaviors %K low touch %K obesity %K obese %K mixed methods analysis %K lifestyle intervention %K young men %K men %K effectiveness %K digital tools %K food intake %K diet %D 2024 %7 5.4.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Young men are vastly underrepresented in lifestyle interventions, suggesting a need to develop appealing yet effective interventions for this population. Objective: This study aimed to determine the acceptability of a self-guided lifestyle intervention designed specifically for young men (age: 18-35 years old). Methods: Semistructured interviews and surveys were completed by 14 men following completion of a remotely delivered, 12-week lifestyle intervention. The intervention included 1 virtual group session, digital tools, access to self-paced web- and mobile-based content, and 12 weekly health risk text messages. We quantitatively and qualitatively examined young men’s experiences with the intervention components of a remotely delivered, self-guided lifestyle intervention targeting weight loss. Data were integrated using convergent mixed methods analysis. Results: Men were a mean age of 29.9 (SD 4.9) years with a mean BMI of 31.0 (SD 4.5) kg/m2. The self-guided aspect was not acceptable, and a majority preferred more check-ins. Participants expressed a desire for a social aspect in future lifestyle interventions. All men found the focus on health risks appealing. A majority of men found the study-issued, Bluetooth-enabled scale acceptable. Conclusions: Acceptability of the self-guided lifestyle intervention was perceived as suboptimal by young men. The findings highlight the need to add intervention components that sustain motivation and provide additional social support for young men. Trial Registration: ClinicalTrials.gov NCT04267263; https://www.clinicaltrials.gov/study/NCT04267263 %M 38578686 %R 10.2196/53841 %U https://formative.jmir.org/2024/1/e53841 %U https://doi.org/10.2196/53841 %U http://www.ncbi.nlm.nih.gov/pubmed/38578686 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55166 %T Combined Motivational Interviewing and Ecological Momentary Intervention to Reduce Hazardous Alcohol Use Among Sexual Minority Cisgender Men and Transgender Individuals: Protocol for a Randomized Controlled Trial %A Lauckner,Carolyn %A Takenaka,Bryce Puesta %A Sesenu,Fidelis %A Brown,Jaime S %A Kirklewski,Sally J %A Nicholson,Erin %A Haney,Kimberly %A Adatorwovor,Reuben %A Boyd,Donte T %A Fallin-Bennett,Keisa %A Restar,Arjee Javellana %A Kershaw,Trace %+ Center for Health Equity Transformation, University of Kentucky, 465 Healthy Kentucky Bldg, 760 Press Ave, Lexington, KY, 40536, United States, 1 859 562 3335, carolyn.lauckner@uky.edu %K alcohol use %K sexual minority %K transgender %K young adults %K mobile health %K mHealth %K HIV risk behaviors %K sexual risk behaviors %K motivational interviewing %K ecological momentary interventions %K mobile phone %D 2024 %7 5.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Sexual minority cisgender men and transgender (SMMT) individuals, particularly emerging adults (aged 18-34 years), often report hazardous drinking. Given that alcohol use increases the likelihood of HIV risk behaviors, and HIV disproportionately affects SMMT individuals, there is a need to test interventions that reduce hazardous alcohol use and subsequent HIV risk behaviors among this population. Ecological momentary interventions (EMIs), which use mobile phones to deliver risk reduction messages based on current location and behaviors, can help to address triggers that lead to drinking in real time. Objective: This study will test an EMI that uses motivational interviewing (MI), smartphone surveys, mobile breathalyzers, and location tracking to provide real-time messaging that addresses triggers for drinking when SMMT individuals visit locations associated with hazardous alcohol use. In addition, the intervention will deliver harm reduction messaging if individuals report engaging in alcohol use. Methods: We will conduct a 3-arm randomized controlled trial (N=405 HIV-negative SMMT individuals; n=135, 33% per arm) comparing the following conditions: (1) Tracking and Reducing Alcohol Consumption (a smartphone-delivered 4-session MI intervention), (2) Tracking and Reducing Alcohol Consumption and Environmental Risk (an EMI combining MI with real-time messaging based on geographic locations that are triggers to drinking), and (3) a smartphone-based alcohol monitoring–only control group. Breathalyzer results and daily self-reports will be used to assess the primary and secondary outcomes of drinking days, drinks per drinking day, binge drinking episodes, and HIV risk behaviors. Additional assessments at baseline, 3 months, 6 months, and 9 months will evaluate exploratory long-term outcomes. Results: The study is part of a 5-year research project funded in August 2022 by the National Institute on Alcohol Abuse and Alcoholism. The first 1.5 years of the study will be dedicated to planning and development activities, including formative research, app design and testing, and message design and testing. The subsequent 3.5 years will see the study complete participant recruitment, data collection, analyses, report writing, and dissemination. We expect to complete all study data collection in or before January 2027. Conclusions: This study will provide novel evidence about the relative efficacy of using a smartphone-delivered MI intervention and real-time messaging to address triggers for hazardous alcohol use and sexual risk behaviors. The EMI approach, which incorporates location-based preventive messaging and behavior surveys, may help to better understand the complexity of daily stressors among SMMT individuals and their impact on hazardous alcohol use and HIV risk behaviors. The tailoring of this intervention toward SMMT individuals helps to address their underrepresentation in existing alcohol use research and will be promising for informing where structural alcohol use prevention and treatment interventions are needed to support SMMT individuals. Trial Registration: ClinicalTrials.gov NCT05576350; https://www.clinicaltrials.gov/study/NCT05576350 International Registered Report Identifier (IRRID): PRR1-10.2196/55166 %M 38578673 %R 10.2196/55166 %U https://www.researchprotocols.org/2024/1/e55166 %U https://doi.org/10.2196/55166 %U http://www.ncbi.nlm.nih.gov/pubmed/38578673 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53301 %T Evaluating a Remotely Delivered Cardio-Oncology Rehabilitation Intervention for Patients With Breast Cancer (REMOTE-COR-B): Protocol for a Single-Arm Feasibility Trial %A Short,Camille E %A Rawstorn,Jonathan C %A Jones,Tamara L %A Edbrooke,Lara %A Hayes,Sandra C %A Maddison,Ralph %A Nightingale,Sophie %A Ismail,Hilmy %A De Boer,Richard %A Hegi-Johnson,Fiona %A Sverdlov,Aaron L %A Bell,Robyn %A Halligan,Irene %A Denehy,Linda %+ Melbourne Centre for Behaviour Change, Melbourne School of Psychological Sciences, The University of Melbourne, Tin Alley, Melbourne, 3010, Australia, 61 0408 288 786, camille.short@unimelb.edu.au %K breast cancer survivor %K breast cancer %K cancer survivor %K cancer %K cardiac rehabilitation %K cardiac %K cardiotoxicity %K cardiovascular disease %K digital health %K efficacy %K exercise %K exercise %K feasibility %K fitness %K rehabilitation intervention %K rehabilitation %K safety %D 2024 %7 5.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Exercise rehabilitation is a promising strategy for reducing cardiovascular disease risk among patients with breast cancer. However, the evidence is primarily derived from programs based at exercise centers with in-person supervised delivery. Conversely, most patients report a preference for home-based rehabilitation. As such, there is a clear need to explore strategies that can provide real-time supervision and coaching while addressing consumer preferences. Evidence from cardiac rehabilitation has demonstrated the noninferiority of a smartphone-based telerehabilitation approach (REMOTE-CR) to improve cardiorespiratory fitness in people with cardiovascular disease compared to a center-based program. Objective: This study aims to assess the feasibility, safety, and preliminary efficacy of the REMOTE-CR program adapted for patients with breast cancer at risk of cardiotoxicity (REMOTE-COR-B). We will also assess the satisfaction and usability of REMOTE-COR-B. Methods: We will conduct a single-arm feasibility study of the REMOTE-COR-B program among patients with stage I-III breast cancer who are at risk of cardiotoxicity (taking treatment type and dose, as well as other common cardiovascular disease risk factors into account) and who are within 24 months of completing primary definitive treatment. Participants (target sample size of 40) will receive an 8-week smartphone-based telerehabilitation exercise program involving remotely delivered real-time supervision and behavior change support. The platform comprises a smartphone and wearable heart rate monitor, as well as a custom-built smartphone app and web application. Participants will be able to attend remotely monitored exercise sessions during set operating hours each week, scheduled in both the morning and evening. Adherence is the primary outcome of the trial, assessed through the number of remotely monitored exercise sessions attended compared to the trial target (ie, 3 sessions per week). Secondary outcomes include additional trial feasibility indicators (eg, recruitment and retention), safety, satisfaction, and usability, and objective and patient-reported efficacy outcomes (cardiovascular fitness, quality of life, fatigue, self-reported exercise, self-efficacy, habit strength, and motivation). Adherence, feasibility, and safety outcomes will be assessed during the intervention period; intervention satisfaction and usability will be assessed post intervention; and objective and patient-reported efficacy outcomes will be assessed at baseline, post intervention (2-month postbaseline assessment), and at follow-up (5-month postbaseline assessment). Results: Recruitment for this trial commenced in March 2023, and 7 participants had been recruited as of the submission of the manuscript. The estimated completion date for the project is October 2024, with results expected to be published in mid-2025. Conclusions: The REMOTE-COR-B intervention is a novel and promising approach to providing exercise therapy to patients with breast cancer at risk of cardiotoxicity who have unique needs and heightened safety risks. This project will provide important information on the extent to which this approach is satisfactory to patients with breast cancer, safe, and potentially effective, which is necessary before larger-scale research or clinical projects. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621001557820; www.anzctr.org.au/ACTRN12621001557820.aspx International Registered Report Identifier (IRRID): DERR1-10.2196/53301 %M 38578682 %R 10.2196/53301 %U https://www.researchprotocols.org/2024/1/e53301 %U https://doi.org/10.2196/53301 %U http://www.ncbi.nlm.nih.gov/pubmed/38578682 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e53489 %T A Web-Based Intervention Based on Acceptance and Commitment Therapy for Family Caregivers of People With Dementia: Mixed Methods Feasibility Study %A Atefi,Golnaz. L %A van Knippenberg,Rosalia J M %A Bartels,Sara Laureen %A Losada-Baltar,Andrés %A Márquez-González,María %A Verhey,Frans R J %A de Vugt,Marjolein E %+ Department of Psychiatry and Neuropsychology, Alzheimer Centrum Limburg, Maastricht University, Dr. Tanslaan 12, Maastricht, 6229 ET, Netherlands, 31 (0) 43 388 1022, g.atefi@maastrichtuniversity.nl %K acceptance and commitment therapy %K ACT %K psychological flexibility %K behavior change %K theory-guided eHealth %K web-based intervention %K supported self-help %K family caregivers %K dementia %D 2024 %7 4.4.2024 %9 Original Paper %J JMIR Aging %G English %X Background: Acceptance and commitment therapy (ACT), as an empirically based third-wave cognitive behavioral therapy, has shown promise in enhancing well-being and functioning across diverse populations. However, in the context of caregiving, the effect size of available ACT interventions remains at best moderate, sometimes accompanied by high dropout rates, highlighting the need for more effective and feasible intervention designs. Objective: The objective of our study was to evaluate the feasibility and acceptability of a fully online ACT program designed for family caregivers of people with dementia. This study aimed to boost psychological flexibility and support caregivers, enabling them to realize and prioritize their own life values alongside their caregiving responsibilities. Methods: A mixed methods feasibility study using an uncontrolled pretest-posttest design was conducted. This intervention included a 9-week web-based self-help program based on ACT incorporating collaborative goal setting and weekly web-based motivational coaching for family caregivers of people with dementia. This study involved 30 informal caregivers recruited through memory clinics and social media platforms in the Netherlands and received approval from the Medical Ethics Committee of the Maastricht University Medical Center+ (NL77389.068.21/metc21-029). Results: A total of 24 caregivers completed the postintervention assessment, indicating a high adherence rate (24/29, 83%). Caregivers reported positive feedback regarding collaborative goal setting, but some found challenges in implementing new skills due to their own habitual responses or the unpredictable context of dementia caregiving. Personalizing the intervention based on individual value preferences was highlighted as beneficial. Conclusions: Compared to other web-based self-help ACT interventions for family caregivers, this intervention showed a high adherence and sufficient level of feasibility, which underscores the use of personalization in delivering web-based interventions. Moreover, the potential of this ACT-based intervention for family caregivers of people with dementia was demonstrated, suggesting that further research and a larger-scale controlled trial are warranted to validate its effectiveness. International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2022-070499 %M 38574360 %R 10.2196/53489 %U https://aging.jmir.org/2024/1/e53489 %U https://doi.org/10.2196/53489 %U http://www.ncbi.nlm.nih.gov/pubmed/38574360 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e54912 %T Behavioral Activation Mobile App to Motivate Smokers to Quit: Feasibility and Pilot Randomized Controlled Trial %A Borrelli,Belinda %A Bartlett,Y Kiera %A Fulford,Daniel %A Frasco,Greg %A Armitage,Christopher J %A Wearden,Alison %+ Center for Behavioral Science Research, Henry M. Goldman School of Dental Medicine, Boston University, Floor 3, 560 Harrison Ave, Boston, MA, 02118, United States, 1 617 358 3358, belindab@bu.edu %K smoking cessation %K mobile app %K motivation %K depressed mood %K depression %K behavioral activation %K negative affect %K positive affect %K quit smoking %K health behavior change %D 2024 %7 4.4.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Behavioral activation (BA) is an evidence-based treatment for depression that fosters engagement in values-based activities to increase access to positive reinforcement. Depressed mood has been shown to hinder smoking cessation. Objective: This study determined the feasibility and preliminary efficacy of a mobile app to motivate smokers to quit by using BA and integrating motivational messages to quit smoking. Methods: Adult smokers (N=56; mean age 34.5, SD 9.52 years) who were not ready to quit smoking within 30 days were recruited from advertisements and randomized to either 8 weeks of the BA app (set 2 values-based activities per week+motivational messages+feedback on changes in smoking, mood, and values-based activities) or the control group (no app; received resources for quitting smoking). All participants completed the baseline and end-of-treatment web-based questionnaires. Controls also completed weekly web-based assessments, and BA app participants completed assessments through the app. Results: There were no dropouts and only 2 participants in each condition did not complete the end-of-treatment questionnaire. The results demonstrated that it is feasible to recruit smokers who are unmotivated to quit into a smoking cessation induction trial: 86% (57/66) of eligible participants were randomized (BA app: n=27; control: n=29). Participants reported high levels of satisfaction: 80% (20/25) of participants said they would recommend the BA app, there were moderate-to-high scores on the Mobile App Rating Scale, and 88% (22/25) of participants rated the app 3 stars or higher (out of 5). There were high levels of BA app engagement: 96% (26/27) of participants planned activities, and 67% (18/27) of participants planned 7 or more activities. High engagement was found even among those who were at the highest risk for continued smoking (low motivation to quit, low confidence to quit, and high negative affect). The results provided support for the hypothesized relationships between BA constructs: greater pleasant activity completion was associated with greater positive affect (b=0.37, SE 0.21; 95% CI –0.05 to 0.79; P=.08), and greater positive affect tended to predict fewer cigarettes smoked the next day (b=–0.19, SE 0.10; 95% CI –0.39 to 0.01; P=.06). Additionally, a greater number of activities planned was associated with lower negative affect (b=–0.26, SE 0.15; 95% CI –0.55 to 0.04; P=.09). Overall, 16% (4/25) of BA app participants set a quit date versus 4% (1/27) among controls, and there were promising (but not significant) trends for motivation and confidence to quit. Conclusions: The findings suggest that a mobile app intervention can be made appealing to smokers who are unmotivated to quit by focusing on aspects most important to them, such as mood management. This theory-based intervention has shown some initial support for the underlying theoretical constructs, and further efficacy testing is warranted in a fully powered trial. %M 38573739 %R 10.2196/54912 %U https://formative.jmir.org/2024/1/e54912 %U https://doi.org/10.2196/54912 %U http://www.ncbi.nlm.nih.gov/pubmed/38573739 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 10 %N %P e46979 %T Co-Design, Development, and Evaluation of a Mobile Solution to Improve Medication Adherence in Cancer: Design Science Research Approach %A Dang,Thu Ha %A Wickramasinghe,Nilmini %A Forkan,Abdur Rahim Mohammad %A Jayaraman,Prem Prakash %A Burbury,Kate %A O’Callaghan,Clare %A Whitechurch,Ashley %A Schofield,Penelope %+ Department of Psychological Sciences, School of Health Sciences, Swinburne University of Technology, John Street, Melbourne, 3122, Australia, 61 422703347, thuhadang@swin.edu.au %K cancer %K behavioral science %K design science research %K digital %K medication adherence %K mobile solution %K Safety and Adherence to Medication and Self-Care Advice in Oncology %K SAMSON %K mobile phone %D 2024 %7 3.4.2024 %9 Original Paper %J JMIR Cancer %G English %X Background: Medication nonadherence negatively impacts the health outcomes of people with cancer as well as health care costs. Digital technologies present opportunities to address this health issue. However, there is limited evidence on how to develop digital interventions that meet the needs of people with cancer, are perceived as useful, and are potentially effective in improving medication adherence. Objective: The objective of this study was to co-design, develop, and preliminarily evaluate an innovative mobile health solution called Safety and Adherence to Medication and Self-Care Advice in Oncology (SAMSON) to improve medication adherence among people with cancer. Methods: Using the 4 cycles and 6 processes of design science research methodology, we co-designed and developed a medication adherence solution for people with cancer. First, we conducted a literature review on medication adherence in cancer and a systematic review of current interventions to address this issue. Behavioral science research was used to conceptualize the design features of SAMSON. Second, we conducted 2 design phases: prototype design and final feature design. Last, we conducted a mixed methods study on patients with hematological cancer over 6 weeks to evaluate the mobile solution. Results: The developed mobile solution, consisting of a mobile app, a web portal, and a cloud-based database, includes 5 modules: medication reminder and acknowledgment, symptom assessment and management, reinforcement, patient profile, and reporting. The quantitative study (n=30) showed that SAMSON was easy to use (21/27, 78%). The app was engaging (18/27, 67%), informative, increased user interactions, and well organized (19/27, 70%). Most of the participants (21/27, 78%) commented that SAMSON’s activities could help to improve their adherence to cancer treatments, and more than half of them (17/27, 63%) would recommend the app to their peers. The qualitative study (n=25) revealed that SAMSON was perceived as helpful in terms of reminding, supporting, and informing patients. Possible barriers to using SAMSON include the app glitches and users’ technical inexperience. Further needs to refine the solution were also identified. Technical improvements and design enhancements will be incorporated into the subsequent iteration. Conclusions: This study demonstrates the successful application of behavioral science research and design science research methodology to design and develop a mobile solution for patients with cancer to be more adherent. The study also highlights the importance of applying rigorous methodologies in developing effective and patient-centered digital intervention solutions. %M 38569178 %R 10.2196/46979 %U https://cancer.jmir.org/2024/1/e46979 %U https://doi.org/10.2196/46979 %U http://www.ncbi.nlm.nih.gov/pubmed/38569178 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e56206 %T Evaluating the User Experience of a Smartphone-Delivered Sexual Health Promotion Program for Older Adults in the Netherlands: Single-Arm Pilot Study %A Correia de Barros,Ana %A Bergmans,Mariëtte %A Hasanaj,Kreshnik %A Krasniqi,Drianë %A Nóbrega,Catarina %A Carvalho Carneiro,Bruna %A Vasconcelos,Priscila A %A Quinta-Gomes,Ana Luísa %A Nobre,Pedro J %A Couto da Silva,Joana %A Mendes-Santos,Cristina %+ Fraunhofer Portugal AICOS, Rua Alfredo Allen, 455, Porto, 4200-135, Portugal, 351 220430306, ana.barros@fraunhofer.pt %K internet interventions %K mobile health %K mHealth %K older adults %K sexual health %K smartphone %K user experience %K pilot study %K mobile phone %D 2024 %7 3.4.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Sexual health is an important component of quality of life in older adults. However, older adults often face barriers to attaining a fulfilling sexual life because of issues such as stigma, lack of information, or difficult access to adequate support. Objective: We aimed to evaluate the user experience of a self-guided, smartphone-delivered program to promote sexual health among older adults. Methods: The mobile app was made available to community-dwelling older adults in the Netherlands, who freely used the app for 8 weeks. User experience and its respective components were assessed using self-developed questionnaires, the System Usability Scale, and semistructured interviews. Quantitative and qualitative data were descriptively and thematically analyzed, respectively. Results: In total, 15 participants (mean age 71.7, SD 9.5 years) completed the trial. Participants showed a neutral to positive stance regarding the mobile app’s usefulness and ease of use. Usability was assessed as “Ok/Fair.” The participants felt confident about using the mobile app. To increase user experience, participants offered suggestions to improve content and interaction, including access to specialized sexual health services. Conclusions: The sexual health promotion program delivered through a smartphone in a self-guided mode was usable. Participants’ perception is that improvements to user experience, namely in content and interaction, as well as connection to external services, will likely improve usefulness and acceptance. %M 38568726 %R 10.2196/56206 %U https://humanfactors.jmir.org/2024/1/e56206 %U https://doi.org/10.2196/56206 %U http://www.ncbi.nlm.nih.gov/pubmed/38568726 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 9 %N %P e52923 %T A Self-Guided Web-Based App (MyDiaMate) for Enhancing Mental Health in Adults With Type 1 Diabetes: Insights From a Real-World Study in the Netherlands %A Embaye,Jiska %A de Wit,Maartje %A Snoek,Frank %+ Department of Medical Psychology, Amsterdam Public Health, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, Amsterdam, 1081 HZ, Netherlands, 31 2004440190, j.embaye@amsterdamumc.nl %K type 1 diabetes %K e-mental health %K web based %K self-help %K real world %K naturalistic %K uptake %K adoption %K usage %K mental health %K distress %K emotional well-being %K cognitive behavioral therapy %K internet-based cognitive behavioral therapy %K Europe %K Netherlands %K Dutch %D 2024 %7 3.4.2024 %9 Original Paper %J JMIR Diabetes %G English %X Background: MyDiaMate is a web-based intervention specifically designed for adults with type 1 diabetes (T1D) that aims to help them improve and maintain their mental health. Prior pilot-testing of MyDiaMate verified its acceptability, feasibility, and usability. Objective: This study aimed to investigate the real-world uptake and usage of MyDiaMate in the Netherlands. Methods: Between March 2021 and December 2022, MyDiaMate was made freely available to Dutch adults with T1D. Usage (participation and completion rates of the modules) was tracked using log data. Users could volunteer to participate in the user profile study, which required filling out a set of baseline questionnaires. The usage of study participants was examined separately for participants scoring above and below the cutoffs of the “Problem Areas in Diabetes” (PAID-11) questionnaire (diabetes distress), the “World Health Organization Well-being Index” (WHO-5) questionnaire (emotional well-being), and the fatigue severity subscale of the “Checklist Individual Strength” (CIS) questionnaire (fatigue). Two months after creating an account, study participants received an evaluation questionnaire to provide us with feedback. Results: In total, 1008 adults created a MyDiaMate account, of whom 343 (34%) participated in the user profile study. The mean age was 43 (SD 14.9; 18-76) years. Most participants were female (n=217, 63.3%) and higher educated (n=198, 57.6%). The majority had been living with T1D for over 5 years (n=241, 73.5%). Of the study participants, 59.1% (n=199) of them reported low emotional well-being (WHO-5 score≤50), 70.9% (n=239) of them reported elevated diabetes distress (PAID-11 score≥18), and 52.4% (n=178) of them reported severe fatigue (CIS score≥35). Participation rates varied between 9.5% (n=19) for social environment to 100% (n=726) for diabetes in balance, which opened by default. Completion rates ranged from 4.3% (n=1) for energy, an extensive cognitive behavioral therapy module, to 68.6% (n=24) for the shorter module on hypos. There were no differences in terms of participation and completion rates of the modules between study participants with a more severe profile, that is, lower emotional well-being, greater diabetes distress, or more fatigue symptoms, and those with a less severe profile. Further, no technical problems were reported, and various suggestions were made by study participants to improve the application, suggesting a need for more personalization. Conclusions: Data from this naturalistic study demonstrated the potential of MyDiaMate as a self-help tool for adults with T1D, supplementary to ongoing diabetes care, to improve healthy coping with diabetes and mental health. Future research is needed to explore engagement strategies and test the efficacy of MyDiaMate in a randomized controlled trial. %M 38568733 %R 10.2196/52923 %U https://diabetes.jmir.org/2024/1/e52923 %U https://doi.org/10.2196/52923 %U http://www.ncbi.nlm.nih.gov/pubmed/38568733 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e52561 %T Designing a Novel Digitally Delivered Antiracism Intervention for Mental Health Clinicians: Exploratory Analysis of Acceptability %A Brown,Tashalee Rushell %A Amir,Habiba %A Hirsch,Drew %A Jansen,Madeline Owens %+ Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, 760 Westwood Plaza, 48-257, Los Angeles, CA, 90024, United States, 1 310 206 0188, tashaleebrown@mednet.ucla.edu %K acceptability %K antiracism %K clinicians %K intervention %K interview study %K mental health %K psychiatry residents %K racism %K social workers %K web-based technology %D 2024 %7 3.4.2024 %9 Short Paper %J JMIR Hum Factors %G English %X Background: There is a great need for evidence-based antiracism interventions targeting mental health clinicians to help mitigate mental health disparities in racially and ethnically minoritized groups. Objective: This study provides an exploratory analysis of mental health clinicians’ perspectives on the acceptability of a web-based antiracism intervention. Methods: Mental health clinicians were recruited from a single academic medical center through outreach emails. Data were collected through individual 30-minute semistructured remote video interviews with participants, then recorded, transcribed, and analyzed using content analysis. Results: A total of 12 mental health clinicians completed the study; 10 out of 12 (83%) were female candidates. Over half (7/12, 58%) of the respondents desired more robust antiracism training in mental health care. Regarding the web-based antiracism intervention, (8/12, 67%) enjoyed the digitally delivered demo module, (7/12, 58%) of respondents suggested web-based content would be further enhanced with the addition of in-person or online group components. Conclusions: Our results suggest a strong need for additional antiracist training for mental health clinicians. Overall, participants responded favorably to novel web-based delivery methods for an antiracism intervention. These findings provide important support for future development and pilot testing of a large-scale digitally enhanced antiracist curriculum targeting mental health clinicians. %M 38568730 %R 10.2196/52561 %U https://humanfactors.jmir.org/2024/1/e52561 %U https://doi.org/10.2196/52561 %U http://www.ncbi.nlm.nih.gov/pubmed/38568730 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e50850 %T Web-Based Emotion Regulation Training for Sexual Health: Randomized Controlled Trial %A Jobim Fischer,Vinicius %A Rossato Holz,Maila %A Billieux,Joël %A Andersson,Gerhard %A Vögele,Claus %+ Institute for Health and Behaviour, Department of Behavioural and Cognitive Sciences, University of Luxembourg, 11, Porte des Sciences, Esch-sur-Alzette, L-4366, Luxembourg, 352 46 66 44 9740, viniciusjfischer@gmail.com %K emotion regulation %K internet %K sexual health %K FSFI %K randomized controlled trial %K intervention %K psychosexual intervention %K sexual disorder %K sexual dysfunction %K internet-based %D 2024 %7 3.4.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Effective emotional regulation (ER) skills are important for sexual function, as they impact emotional awareness and expression during sexual activity, and therefore, satisfaction and distress. Emotion regulation interventions may offer a promising approach to improve sexual health. Web-based emotion regulation may be a therapeutic strategy for men and women with sexual health concerns. Nevertheless, there is a scarcity of intervention trials investigating its effects in this context, much less using the internet. Objective: This study aims to investigate the effects of a web-based emotion regulation training program for sexual function in both men and women. Methods: The participants were recruited based on their self-reported sexual problems, which for men was defined by a score of <25 on the International Index Erectile Function (IIEF) and for women by a score of <26.55 on the Female Sexual Function Index (FSFI). The final sample included 60 participants who were randomized to either a web-based emotion regulation training for sexual function or to a waitlist control group. The treatment consisted of an 8-week web-based emotion regulation training for sexual function. The participants were assessed at baseline, post intervention, and the 3-month follow-up. Results: Of the 60 participants included, only 6 completed all 3 assessment points (n=5, 20% in the treatment group and n=1, 5% in the waitlist control group) after receiving the intervention. At follow-up, there were no significant differences between groups in any measure. Among the intervention completers, large-to-moderate within-group effect sizes were observed between the assessment points on measures of emotion regulation, depression, lubrication, orgasm, thoughts of sexual failure, and abuse during sexual activity. The adherence rate was very low, limiting the generalizability of the findings. Conclusions: Participants who completed the intervention showed improvements in both sexual function domains and emotion regulation. Nonetheless, due to a high dropout rate, this trial failed to collect sufficient data to allow for any conclusions to be drawn on treatment effects. Trial Registration: ClinicalTrials.gov NCT04792177; https://clinicaltrials.gov/study/NCT04792177 %M 38568720 %R 10.2196/50850 %U https://formative.jmir.org/2024/1/e50850 %U https://doi.org/10.2196/50850 %U http://www.ncbi.nlm.nih.gov/pubmed/38568720 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e54940 %T The Impact of Digital Self-Monitoring of Weight on Improving Diabetes Clinical Outcomes: Quasi-Randomized Study %A Fundoiano-Hershcovitz,‪Yifat %A Ritholz,Marilyn D %A Horwitz,David L %A Behar,Ephraim %A Manejwala,Omar %A Goldstein,Pavel %+ Dario Health, Tarshish 5, Caesarea, 3079821, Israel, 972 525296979, yifat@dariohealth.com %K obesity %K diabetes management %K weight monitoring %K digital health platform %K self-monitoring %K clinical outcome %K type 2 diabetes %K weight changes %K blood glucose %K patient empowerment %D 2024 %7 2.4.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: The management of type 2 diabetes (T2D) and obesity, particularly in the context of self-monitoring, remains a critical challenge in health care. As nearly 80% to 90% of patients with T2D have overweight or obesity, there is a compelling need for interventions that can effectively manage both conditions simultaneously. One of the goals in managing chronic conditions is to increase awareness and generate behavioral change to improve outcomes in diabetes and related comorbidities, such as overweight or obesity. There is a lack of real-life evidence to test the impact of self-monitoring of weight on glycemic outcomes and its underlying mechanisms. Objective: This study aims to assess the efficacy of digital self-monitoring of weight on blood glucose (BG) levels during diabetes management, investigating whether the weight changes may drive glucose fluctuations. Methods: In this retrospective, real-world quasi-randomized study, 50% of the individuals who regularly used the weight monitoring (WM) feature were propensity score matched with 50% of the users who did not use the weight monitoring feature (NWM) based on demographic and clinical characteristics. All the patients were diagnosed with T2D and tracked their BG levels. We analyzed monthly aggregated data 6 months before and after starting their weight monitoring. A piecewise mixed model was used for analyzing the time trajectories of BG and weight as well as exploring the disaggregation effect of between- and within-patient lagged effects of weight on BG. Results: The WM group exhibited a significant reduction in BG levels post intervention (P<.001), whereas the nonmonitoring group showed no significant changes (P=.59), and both groups showed no differences in BG pattern before the intervention (P=.59). Furthermore, the WM group achieved a meaningful decrease in BMI (P<.001). Finally, both within-patient (P<.001) and between-patient (P=.008) weight variability was positively associated with BG levels. However, 1-month lagged back BMI was not associated with BG levels (P=.36). Conclusions: This study highlights the substantial benefits of self-monitoring of weight in managing BG levels in patients with diabetes, facilitated by a digital health platform, and advocates for the integration of digital self-monitoring tools in chronic disease management. We also provide initial evidence of testing the underlying mechanisms associated with BG management, underscoring the potential role of patient empowerment. %M 38564266 %R 10.2196/54940 %U https://www.jmir.org/2024/1/e54940 %U https://doi.org/10.2196/54940 %U http://www.ncbi.nlm.nih.gov/pubmed/38564266 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e54788 %T Internet-Based Interventions for Preventing Premature Birth Among Pregnant Women: Systematic Review %A Kim,Sun-Hee %A Park,Jin-Hwa %A Jung,Sun-Young %A De Gagne,Jennie C %+ College of Nursing, Research Institute of Nursing Science, Daegu Catholic University, Duryugongwon-ro 17-gil 33, Nam-gu, Daegu, 42472, Republic of Korea, 82 53 650 4977, syjung@cu.ac.kr %K anxiety %K body weight %K depression %K gestational diabetes mellitus %K high-risk behavior %K internet-based interventions %K neonatal outcomes %K pregnancy %K premature birth %K pregnancy outcomes %K stress %K systematic review %D 2024 %7 2.4.2024 %9 Review %J JMIR Pediatr Parent %G English %X Background: Premature birth rates have slightly increased globally, making its prevention critical for both short-term and long-term health outcomes. Various interventions have been developed in response to the multifaceted risk factors for premature birth, including internet-based programs. These programs offer accessibility and enhanced engagement; however, their overall efficacy in preventing premature births requires thorough evaluation. Objective: This systematic review aims to identify the study designs and assess the effectiveness of internet-based interventions in preventing premature birth among pregnant women. Methods: A comprehensive search of the MEDLINE, Embase, CINAHL, and Cochrane Library databases was conducted to identify randomized trials and quasi-experimental studies evaluating internet-based interventions for premature birth prevention in pregnant women. The search was inclusive, with no restrictions based on language or geographical location, allowing for a comprehensive global perspective. The time frame for the inclusion of studies extended until February 2023. The risk of bias (RoB) in each study was independently assessed by 3 authors forming pairs, using the revised Cochrane RoB tool (RoB 2) for randomized trials, as per the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Owing to heterogeneity in populations, measurements, and interventions, a meta-analysis was not conducted. Results: This review included 26 articles, comprising 12 intention-to-treat and 14 per-protocol studies. The overall RoB was high in most intention-to-treat studies and of some concern in most per-protocol studies. The target populations varied, including nonspecific pregnant women, those with gestational diabetes mellitus (GDM) or those at risk of GDM, individuals with anxiety or depression, and those experiencing preterm labor. Psychosocial, physiological, and wellness health outcomes were evaluated. Internet-based interventions effectively reduced stress/distress in nonspecific pregnant women but not in those experiencing preterm labor. Their effectiveness in reducing anxiety and depression varied, with inconsistent results among different groups. In women with GDM or those at risk of GDM, interventions successfully controlled fasting plasma glucose and 2-hour postprandial plasma glucose levels but did not consistently manage glycated hemoglobin levels. These interventions did not reduce the incidence of premature births across the various populations studied. The effectiveness of these internet-based interventions in addressing substance or alcohol abuse and insomnia also varied. Conclusions: Internet-based interventions show promise in improving psychosocial health and managing blood sugar to prevent premature birth, highlighting variability in effectiveness across different risk factors. Further research, including clinical trials, is vital for developing, evaluating, and disseminating effective, safe internet-based interventions. Establishing standardized measurement tools and rigorous evaluation processes is crucial for enhancing these interventions’ effectiveness and reliability in clinical practice, significantly contributing to preventing premature births and improving maternal health outcomes. Trial Registration: PROSPERO CRD42021278847; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021278847 %M 38564247 %R 10.2196/54788 %U https://pediatrics.jmir.org/2024/1/e54788 %U https://doi.org/10.2196/54788 %U http://www.ncbi.nlm.nih.gov/pubmed/38564247 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53684 %T Experimentally Induced Reductions in Alcohol Consumption and Brain, Cognitive, and Clinical Outcomes in Older Persons With and Those Without HIV Infection (30-Day Challenge Study): Protocol for a Nonrandomized Clinical Trial %A Cook,Robert L %A Richards,Veronica L %A Gullett,Joseph M %A Lerner,Brenda D G %A Zhou,Zhi %A Porges,Eric C %A Wang,Yan %A Kahler,Christopher W %A Barnett,Nancy P %A Li,Zhigang %A Pallikkuth,Suresh %A Thomas,Emmanuel %A Rodriguez,Allan %A Bryant,Kendall J %A Ghare,Smita %A Barve,Shirish %A Govind,Varan %A Dévieux,Jessy G %A Cohen,Ronald A %A , %+ Southern HIV and Alcohol Research Consortium, University of Florida, 2004 Mowry Road, Department of Epidemiology, Gainesville, FL, 32610, United States, 1 3522735869, cookrl@ufl.edu %K alcohol %K contingency management %K biosensor %K HIV infection %K cognitive function %D 2024 %7 2.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Both alcohol consumption and HIV infection are associated with worse brain, cognitive, and clinical outcomes in older adults. However, the extent to which brain and cognitive dysfunction is reversible with reduction or cessation of drinking is unknown. Objective: The 30-Day Challenge study was designed to determine whether reduction or cessation of drinking would be associated with improvements in cognition, reduction of systemic and brain inflammation, and improvement in HIV-related outcomes in adults with heavy drinking. Methods: The study design was a mechanistic experimental trial, in which all participants received an alcohol reduction intervention followed by repeated assessments of behavioral and clinical outcomes. Persons were eligible if they were 45 years of age or older, had weekly alcohol consumption of 21 or more drinks (men) or 14 or more drinks (women), and were not at high risk of alcohol withdrawal. After a baseline assessment, participants received an intervention consisting of contingency management (money for nondrinking days) for at least 30 days followed by a brief motivational interview. After this, participants could either resume drinking or not. Study questionnaires, neurocognitive assessments, neuroimaging, and blood, urine, and stool samples were collected at baseline, 30 days, 90 days, and 1 year after enrollment. Results: We enrolled 57 persons with heavy drinking who initiated the contingency management protocol (mean age 56 years, SD 4.6 years; 63%, n=36 male, 77%, n=44 Black, and 58%, n=33 people with HIV) of whom 50 completed 30-day follow-up and 43 the 90-day follow-up. The planned study procedures were interrupted and modified due to the COVID-19 pandemic of 2020-2021. Conclusions: This was the first study seeking to assess changes in brain (neuroimaging) and cognition after alcohol intervention in nontreatment-seeking people with HIV together with people without HIV as controls. Study design strengths, limitations, and lessons for future study design considerations are discussed. Planned analyses are in progress, after which deidentified study data will be available for sharing. Trial Registration: ClinicalTrials.gov NCT03353701; https://clinicaltrials.gov/study/NCT03353701 International Registered Report Identifier (IRRID): DERR1-10.2196/53684 %M 38564243 %R 10.2196/53684 %U https://www.researchprotocols.org/2024/1/e53684 %U https://doi.org/10.2196/53684 %U http://www.ncbi.nlm.nih.gov/pubmed/38564243 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e49946 %T A Digital Platform (Telepalliation) for Patients in Palliative Care and Their Relatives: Protocol for a Multimethod Randomized Controlled Trial %A Sigaard,Jarl Voss Andersen %A Henneberg,Nanna Celina %A Schacksen,Cathrine Skov %A Kronborg,Sissel Højsted %A Petrini,Laura %A Kidholm,Kristian %A Birgisdóttir,Una Rósa %A Spindler,Helle %A Dinesen,Birthe %+ Hospital of Southwest Jutland, University Hospital of Southern Denmark, Finsensgade 35, Esbjerg, 6700, Denmark, 45 23832739, jarl.sigaard@rsyd.dk %K palliative care %K digital health %K quality of life %K telehealth %K interdisciplinary research %K randomized controlled trial %D 2024 %7 2.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The World Health Organization defines end-of-life palliative care as “prevention and relief of suffering, by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual.” Over 20 million people worldwide are in need of palliative care. In Denmark, palliative care is given at a general and a specialist level. The general level comprises health care professionals (HCPs) who do not perform palliative care full-time. The specialist level comprises specialized palliative care (SPC), where HCPs perform palliative care full-time. In total, 20%-30% of patients who need palliative care are referred to SPC. Challenges with SPC include a short time span from referral to end of life, patients who are very ill and may therefore find it hard to travel to an outpatient clinic, and the SPC unit having a relatively small staff. The need for SPC is expected to rise, as the number of patients dying from terminal diseases is increasing. Telehealth has been successfully implemented in different home care settings, including palliative care. Objective: The aim of the study is to present the research design of the clinical testing of a telepalliation program by the use of a digital platform for patients in palliative care and their relatives. Methods: The telepalliation program will be conducted as a multimethod randomized controlled trial. The intervention group will follow the telepalliation program, while the control group will follow the traditional standard of care program for palliative care. The primary outcome of the study is increased quality of life. Secondary outcomes include enhanced sense of security; reduced experience of pain; satisfactory experiences of patients and relatives with the TelePal platform and degree of satisfaction in being a part of the program; experiences with the use of the TelePal platform on the part of HCPs and the professionals’ experiences of being a part of the program; the use of a cross-sector communication platform and the telepalliation program by patients, relatives, and HCPs; and the projected lower cost of health care services. These outcomes will be assessed using questionnaires, data generated by digital technologies, and semistructured interviews. Results: The collection of data began in May 2021 and will be completed in August 2024. The results of the study will be published in peer-reviewed journals and presented at international conferences. Results from the telepalliation program are expected to be published by fall 2024. Conclusions: The expected outcomes of the study are increased quality of life and increased sense of security. We also expect that the study will have a clinical impact on future telepalliation for those patients who are referred to a palliative team. Trial Registration: ClinicalTrials.gov NCT04995848; https://clinicaltrials.gov/study/NCT04995848 International Registered Report Identifier (IRRID): DERR1-10.2196/49946 %M 38564264 %R 10.2196/49946 %U https://www.researchprotocols.org/2024/1/e49946 %U https://doi.org/10.2196/49946 %U http://www.ncbi.nlm.nih.gov/pubmed/38564264 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e49217 %T A Novel Blended Transdiagnostic Intervention (eOrygen) for Youth Psychosis and Borderline Personality Disorder: Uncontrolled Single-Group Pilot Study %A O'Sullivan,Shaunagh %A McEnery,Carla %A Cagliarini,Daniela %A Hinton,Jordan D X %A Valentine,Lee %A Nicholas,Jennifer %A Chen,Nicola A %A Castagnini,Emily %A Lester,Jacqueline %A Kanellopoulos,Esta %A D'Alfonso,Simon %A Gleeson,John F %A Alvarez-Jimenez,Mario %+ Orygen, 35 Poplar Road, Parkville, Australia, 61 428282470, shaunagh.osullivan@orygen.org.au %K digital intervention %K blended care %K youth mental health %K transdiagnostic intervention %K psychotic disorders %K borderline personality disorder %K digital health %K mobile phone %D 2024 %7 1.4.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Integrating innovative digital mental health interventions within specialist services is a promising strategy to address the shortcomings of both face-to-face and web-based mental health services. However, despite young people’s preferences and calls for integration of these services, current mental health services rarely offer blended models of care. Objective: This pilot study tested an integrated digital and face-to-face transdiagnostic intervention (eOrygen) as a blended model of care for youth psychosis and borderline personality disorder. The primary aim was to evaluate the feasibility, acceptability, and safety of eOrygen. The secondary aim was to assess pre-post changes in key clinical and psychosocial outcomes. An exploratory aim was to explore the barriers and facilitators identified by young people and clinicians in implementing a blended model of care into practice. Methods: A total of 33 young people (aged 15-25 years) and 18 clinicians were recruited over 4 months from two youth mental health services in Melbourne, Victoria, Australia: (1) the Early Psychosis Prevention and Intervention Centre, an early intervention service for first-episode psychosis; and (2) the Helping Young People Early Clinic, an early intervention service for borderline personality disorder. The feasibility, acceptability, and safety of eOrygen were evaluated via an uncontrolled single-group study. Repeated measures 2-tailed t tests assessed changes in clinical and psychosocial outcomes between before and after the intervention (3 months). Eight semistructured qualitative interviews were conducted with the young people, and 3 focus groups, attended by 15 (83%) of the 18 clinicians, were conducted after the intervention. Results: eOrygen was found to be feasible, acceptable, and safe. Feasibility was established owing to a low refusal rate of 25% (15/59) and by exceeding our goal of young people recruited to the study per clinician. Acceptability was established because 93% (22/24) of the young people reported that they would recommend eOrygen to others, and safety was established because no adverse events or unlawful entries were recorded and there were no worsening of clinical and social outcome measures. Interviews with the young people identified facilitators to engagement such as peer support and personalized therapy content, as well as barriers such as low motivation, social anxiety, and privacy concerns. The clinician focus groups identified evidence-based content as an implementation facilitator, whereas a lack of familiarity with the platform was identified as a barrier owing to clinicians’ competing priorities, such as concerns related to risk and handling acute presentations, as well as the challenge of being understaffed. Conclusions: eOrygen as a blended transdiagnostic intervention has the potential to increase therapeutic continuity, engagement, alliance, and intensity. Future research will need to establish the effectiveness of blended models of care for young people with complex mental health conditions and determine how to optimize the implementation of such models into specialized services. %M 38557432 %R 10.2196/49217 %U https://mental.jmir.org/2024/1/e49217 %U https://doi.org/10.2196/49217 %U http://www.ncbi.nlm.nih.gov/pubmed/38557432 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e48068 %T Development and Evaluation of a Digital App for Patient Self-Management of Opioid Use Disorder: Usability, Acceptability, and Utility Study %A King Jr,Van Lewis %A Siegel,Gregg %A Priesmeyer,Henry Richard %A Siegel,Leslie H %A Potter,Jennifer S %+ Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center San Antonio, 5109 Medical Drive, San Antonio, TX, 78229, United States, 1 210 450 8058, kingvl@uthscsa.edu %K opioid use disorder %K digital health %K behavioral medicine %K KIOS %K mHealth %K substance use disorder %K substance use treatment %K self-management %K opioid misuse %K substance use %K social support %K KIOS app %K KIOS application %K software %K patient-centered %K opioid %D 2024 %7 1.4.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Self-management of opioid use disorder (OUD) is an important component of treatment. Many patients receiving opioid agonist treatment in methadone maintenance treatment settings benefit from counseling treatments to help them improve their recovery skills but have insufficient access to these treatments between clinic appointments. In addition, many addiction medicine clinicians treating patients with OUD in a general medical clinic setting do not have consistent access to counseling referrals for their patients. This can lead to decreases in both treatment retention and overall progress in the patient’s recovery from substance misuse. Digital apps may help to bridge this gap by coaching, supporting, and reinforcing behavioral change that is initiated and directed by their psychosocial and medical providers. Objective: This study aimed to conduct an acceptability, usability, and utility pilot study of the KIOS app to address these clinical needs. Methods: We developed a unique, patient-centered computational software system (KIOS; Biomedical Development Corporation) to assist in managing OUD in an outpatient, methadone maintenance clinic setting. KIOS tracks interacting self-reported symptoms (craving, depressed mood, anxiety, irritability, pain, agitation or restlessness, difficulty sleeping, absenteeism, difficulty with usual activities, and conflicts with others) to determine changes in both the trajectory and severity of symptom patterns over time. KIOS then applies a proprietary algorithm to assess the individual’s patterns of symptom interaction in accordance with models previously established by OUD experts. After this analysis, KIOS provides specific behavioral advice addressing the individual’s changing trajectory of symptoms to help the person self-manage their symptoms. The KIOS software also provides analytics on the self-reported data that can be used by patients, clinicians, and researchers to track outcomes. Results: In a 4-week acceptability, usability (mean System Usability Scale-Modified score 89.5, SD 9.2, maximum of 10.0), and utility (mean KIOS utility questionnaire score 6.32, SD 0.25, maximum of 7.0) pilot study of 15 methadone-maintained participants with OUD, user experience, usability, and software-generated advice received high and positive assessment scores. The KIOS clinical variables closely correlated with craving self-report measures. Therefore, managing these variables with advice generated by the KIOS software could have an impact on craving and ultimately substance use. Conclusions: KIOS tracks key clinical variables and generates advice specifically relevant to the patient’s current and changing clinical state. Patients in this pilot study assigned high positive values to the KIOS user experience, ease of use, and the appropriateness, relevance, and usefulness of the specific behavioral guidance they received to match their evolving experiences. KIOS may therefore be useful to augment in-person treatment of opioid agonist patients and help fill treatment gaps that currently exist in the continuum of care. A National Institute on Drug Abuse–funded randomized controlled trial of KIOS to augment in-person treatment of patients with OUD is currently being conducted. %M 38557501 %R 10.2196/48068 %U https://formative.jmir.org/2024/1/e48068 %U https://doi.org/10.2196/48068 %U http://www.ncbi.nlm.nih.gov/pubmed/38557501 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e54282 %T Effects of a Digital Mental Health Intervention on Perceived Stress and Rumination in Adolescents Aged 13 to 17 Years: Randomized Controlled Trial %A Boucher,Eliane M %A Ward,Haley %A Miles,Cynthia J %A Henry,Robert D %A Stoeckl,Sarah Elizabeth %+ Twill, 114 Fifth Avenue, 10th Floor, New York, NY, 10011, United States, 1 432 258 5233, eliane@twill.health %K digital intervention %K adolescents %K adolescent %K stress management %K mental health %K mobile phone %K mobile health %K mHealth %K teen %K teens %K teenager %K teenagers %K stress %K mental health %K rumination %K brooding %K randomized controlled trial %K RCT %K randomized %K controlled trial %K controlled trials %K digital mental health intervention %K DMHI %K digital health %D 2024 %7 29.3.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Although adolescents report high levels of stress, they report engaging in few stress management techniques. Consequently, developing effective and targeted programs to help address this transdiagnostic risk factor in adolescence is particularly important. Most stress management programs for adolescents are delivered within schools, and the evidence for these programs is mixed, suggesting a need for alternative options for stress management among adolescents. Objective: The aim of the study is to test the short-term effects of a self-guided digital mental health intervention (DMHI) designed for adolescents on perceived stress and rumination (ie, brooding). Methods: This was a 12-week, 2-arm decentralized randomized controlled trial of adolescents aged 13 to 17 years who presented with elevated levels of perceived stress and brooding. Participants were randomly assigned to engage with a self-guided DMHI (Happify for Teens) or to a waitlist control. Participants assigned to the intervention group were given access to the program for 12 weeks. Happify for Teens consists of various evidence-based activities drawn from therapeutic modalities such as cognitive behavioral therapy, positive psychology, and mindfulness, which are then organized into several programs targeting specific areas of concern (eg, Stress Buster 101). Participants in the waitlist control received access to this product for 12 weeks upon completing the study. Participants in both groups completed measures of perceived stress, brooding, optimism, sleep disturbance, and loneliness at baseline, 4 weeks, 8 weeks, and 12 weeks. Changes in outcomes between the intervention and waitlist control groups were assessed using repeated-measures multilevel models. Results: Of the 303 participants included in data analyses, 132 were assigned to the intervention and 171 to the waitlist. There were significantly greater improvements in the intervention condition for perceived stress (intervention: B=–1.50; 95% CI –1.82 to –1.19; P<.001 and control: B=–0.09; 95% CI –0.44 to 0.26; P=.61), brooding (intervention: B=–0.84; 95% CI –1.00 to –0.68; P<.001 and control: B=–0.30; 95% CI –0.47 to –0.12; P=.001), and loneliness (intervention: B=–0.96; 95% CI –1.2 to –0.73; P<.001 and control: B=–0.38; 95% CI: –0.64 to –0.12; P=.005) over the 12-week study period. Changes in optimism and sleep disturbance were not significantly different across groups (Ps≥.096). Conclusions: Happify for Teens was effective at reducing perceived stress, rumination, and loneliness among adolescents over 12 weeks when compared to a waitlist control group. Our data reveal the potential benefits of DMHIs for adolescents, which may present a more scalable, destigmatized, and cost-effective alternative to school-based programs. Trial Registration: ClinicalTrials.gov NCT04567888; https://clinicaltrials.gov/ct2/show/NCT04567888 International Registered Report Identifier (IRRID): RR2-10.2196/25545 %M 38551617 %R 10.2196/54282 %U https://www.jmir.org/2024/1/e54282 %U https://doi.org/10.2196/54282 %U http://www.ncbi.nlm.nih.gov/pubmed/38551617 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e50907 %T Developing and Implementing a Web-Based Branching Logic Survey to Support Psychiatric Crisis Evaluations of Individuals With Developmental Disabilities: Qualitative Study and Evaluation of Validity %A Bilder,Deborah A %A Mthembu,Mariah %A Worsham,Whitney %A Aguayo,Patricia %A Knight,Jacob R %A Deng,Steven W %A Singh,Tejinder P %A Davis,John %+ University of Utah Huntsman Mental Health Institute, 383 Colorow Drive, Room 360, Salt Lake City, UT, 84108, United States, 1 801 410 0852, deborah.bilder@hsc.utah.edu %K developmental disabilities %K disruptive behavior %K psychiatric comorbidity %K web-based %K psychiatric crisis %K disability %K mental health %K behavioral crises %K intervention %K general population %K screening %K accuracy %K mood disorder %K sources of distress %K autism %K intellectual disability %D 2024 %7 29.3.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Individuals with developmental disabilities (DD) experience increased rates of emotional and behavioral crises that necessitate assessment and intervention. Psychiatric disorders can contribute to crises; however, screening measures developed for the general population are inadequate for those with DD. Medical conditions can exacerbate crises and merit evaluation. Screening tools using checklist formats, even when designed for DD, are too limited in depth and scope for crisis assessments. The Sources of Distress survey implements a web-based branching logic format to screen for common psychiatric and medical conditions experienced by individuals with DD by querying caregiver knowledge and observations. Objective: This paper aims to (1) describe the initial survey development, (2) report on focus group and expert review processes and findings, and (3) present results from the survey’s clinical implementation and evaluation of validity. Methods: Sources of Distress was reviewed by focus groups and clinical experts; this feedback informed survey revisions. The survey was subsequently implemented in clinical settings to augment providers’ psychiatric and medical history taking. Informal and formal consults followed the completion of Sources of Distress for a subset of individuals. A records review was performed to identify working diagnoses established during these consults. Results: Focus group members (n=17) expressed positive feedback overall about the survey’s content and provided specific recommendations to add categories and items. The survey was completed for 231 individuals with DD in the clinical setting (n=161, 69.7% men and boys; mean age 17.7, SD 10.3; range 2-65 years). Consults were performed for 149 individuals (n=102, 68.5% men and boys; mean age 18.9, SD 10.9 years), generating working diagnoses to compare survey screening results. Sources of Distress accuracy rates were 91% (95% CI 85%-95%) for posttraumatic stress disorder, 87% (95% CI 81%-92%) for anxiety, 87% (95% CI 81%-92%) for episodic expansive mood and bipolar disorder, 82% (95% CI 75%-87%) for psychotic disorder, 79% (95% CI 71%-85%) for unipolar depression, and 76% (95% CI 69%-82%) for attention-deficit/hyperactivity disorder. While no specific survey items or screening algorithm existed for unspecified mood disorder and disruptive mood dysregulation disorder, these conditions were caregiver-reported and working diagnoses for 11.7% (27/231) and 16.8% (25/149) of individuals, respectively. Conclusions: Caregivers described Sources of Distress as an acceptable tool for sharing their knowledge and insights about individuals with DD who present in crisis. As a screening tool, this survey demonstrates good accuracy. However, better differentiation among mood disorders is needed, including the addition of items and screening algorithm for unspecified mood disorder and disruptive mood dysregulation disorder. Additional validation efforts are necessary to include a more geographically diverse population and reevaluate mood disorder differentiation. Future study is merited to investigate the survey’s impact on the psychiatric and medical management of distress in individuals with DD. %M 38551644 %R 10.2196/50907 %U https://mental.jmir.org/2024/1/e50907 %U https://doi.org/10.2196/50907 %U http://www.ncbi.nlm.nih.gov/pubmed/38551644 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e56002 %T Preferences for mHealth Intervention to Address Mental Health Challenges Among Men Who Have Sex With Men in Nepal: Qualitative Study %A Gautam,Kamal %A Aguilar,Camille %A Paudel,Kiran %A Dhakal,Manisha %A Wickersham,Jeffrey A %A Acharya,Bibhav %A Sapkota,Sabitri %A Deuba,Keshab %A Shrestha,Roman %+ Department of Allied Health Sciences, University of Connecticut, 358 Mansfield Road, Storrs, CT, 06269, United States, 1 860 486 2834, roman.shrestha@uconn.edu %K mental health %K MSM %K mHealth %K smartphone apps %K digital health %K Nepal %K gay %K homosexual %K homosexuality %K men who have sex with men %K focus group %K focus groups %K qualitative %K barrier %K barriers %K thematic %K mHealth %K mobile health %K app %K apps %K applications %K applications %D 2024 %7 29.3.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Men who have sex with men (MSM) are disproportionately burdened by poor mental health. Despite the increasing burden, evidence-based interventions for MSM are largely nonexistent in Nepal. Objective: This study explored mental health concerns, contributing factors, barriers to mental health care and support, and preferred interventions to improve access to and use of mental health support services among MSM in Nepal. Methods: We conducted focus groups with MSM in Kathmandu, Nepal, in January 2023. In total, 28 participants took part in 5 focus group sessions. Participants discussed several topics related to the mental health issues they experienced, factors contributing to these issues, and their suggestions for potential interventions to address existing barriers. The discussions were recorded, transcribed, and analyzed using Dedoose (version 9.0.54; SocioCultural Research Consultants, LLC) software for thematic analysis. Results: Participants reported substantial mental health problems, including anxiety, depression, suicidal ideation, and behaviors. Contributing factors included family rejection, isolation, bullying, stigma, discrimination, and fear of HIV and other sexually transmitted infections. Barriers to accessing services included cost, lack of lesbian, gay, bisexual, transgender, intersex, queer, and asexual (LGBTIQA+)–friendly providers, and the stigma associated with mental health and sexuality. Participants suggested a smartphone app with features such as a mental health screening tool, digital consultation, helpline number, directory of LGBTIQA+-friendly providers, mental health resources, and a discussion forum for peer support as potential solutions. Participants emphasized the importance of privacy and confidentiality to ensure mobile apps are safe and accessible. Conclusions: The findings of this study have potential transferability to other low-resource settings facing similar challenges. Intervention developers can use these findings to design tailored mobile apps to facilitate mental health care delivery and support for MSM and other marginalized groups. %M 38551632 %R 10.2196/56002 %U https://humanfactors.jmir.org/2024/1/e56002 %U https://doi.org/10.2196/56002 %U http://www.ncbi.nlm.nih.gov/pubmed/38551632 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e50330 %T Weight Gain Prevention Outcomes From a Pragmatic Digital Health Intervention With Community Health Center Patients: Randomized Controlled Trial %A Miller,Hailey N %A Gallis,John A %A Berger,Miriam B %A Askew,Sandy %A Egger,Joseph R %A Kay,Melissa C %A Finkelstein,Eric Andrew %A de Leon,Mia %A DeVries,Abigail %A Brewer,Ashley %A Holder,Marni Gwyther %A Bennett,Gary G %+ Duke Digital Health Science Center, Duke University, 417 Chapel Drive, Room 048, Campus Box 90086, Durham, NC, 27708, United States, 1 919 613 8398, miriam.berger@duke.edu %K weight gain prevention %K digital health %K pragmatic clinical trial %K primary care %K health disparities %K obesity %K obese %K prevalence %K weight management %K overweight %K intervention %D 2024 %7 28.3.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: The prevalence of obesity and its associated comorbidities continue to rise in the United States. Populations who are uninsured and from racial and ethnic minority groups continue to be disproportionately affected. These populations also experience fewer clinically meaningful outcomes in most weight loss trials. Weight gain prevention presents a useful strategy for individuals who experience barriers to weight loss. Given the often-limited weight management resources available to patients in primary care settings serving vulnerable patients, evaluating interventions with pragmatic designs may help inform the design of comprehensive obesity care delivered in primary care. Objective: This study aims to evaluate the effectiveness of Balance, a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention, delivered to patients receiving primary care within federally qualified community health centers. Methods: Balance was a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention delivered to individuals who had a BMI of 25-40 kg/m2, spoke English or Spanish, and were receiving primary care within a network of federally qualified community health centers in North Carolina. The Balance intervention was designed to encourage behavioral changes that result in a slight energy deficit. Intervention participants received tailored goal setting and tracking, skills training, self-monitoring, and responsive health coaching from registered dietitians. Weight was measured at regular primary care visits and documented in the electronic health record. We compared the percentage of ≤3% weight gain in each arm at 24 months after randomization—our primary outcome—using individual empirical best linear unbiased predictors from the linear mixed-effects model. We used individual empirical best linear unbiased predictors from participants with at least 1 electronic health record weight documented within a 6-month window centered on the 24-month time point. Results: We randomized 443 participants, of which 223 (50.3%) participants were allocated to the intervention arm. At baseline, participants had a mean BMI of 32.6 kg/m2. Most participants were Latino or Hispanic (n=200, 45.1%) or non–Latino or Hispanic White (n=115, 26%). In total, 53% (n=235) of participants had at least 1 visit with weight measured in the primary time window. The intervention group had a higher proportion with ≤3% weight gain at 6 months (risk ratio=1.12, 95% CI 0.94-1.28; risk difference=9.5, 95% CI –4.5 to 16.4 percentage points). This difference attenuated to the null by 24 months (risk ratio=1.00, 95% CI 0.82-1.20; risk difference=0.2, 95% CI –12.1 to 11.0 percentage points). Conclusions: In adults with overweight or obesity receiving primary care at a community health center, we did not find long-term evidence to support the dissemination of a digital health intervention for weight gain prevention. Trial Registration: ClinicalTrials.gov NCT03003403; https://clinicaltrials.gov/study/NCT03003403 International Registered Report Identifier (IRRID): RR2-10.1186/s12889-019-6926-7 %M 38416574 %R 10.2196/50330 %U https://www.jmir.org/2024/1/e50330 %U https://doi.org/10.2196/50330 %U http://www.ncbi.nlm.nih.gov/pubmed/38416574 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e52763 %T Translating Suicide Safety Planning Components Into the Design of mHealth App Features: Systematic Review %A Gryglewicz,Kim %A Orr,Victoria L %A McNeil,Marissa J %A Taliaferro,Lindsay A %A Hines,Serenea %A Duffy,Taylor L %A Wisniewski,Pamela J %+ School of Social Work, University of Central Florida, 12805 Pegasus Drive HS I, Orlando, FL, 32816, United States, 1 14078232954, kgryglew@ucf.edu %K suicide prevention %K suicide safety planning %K mobile health %K mHealth apps %K eHealth %K digital health %K systematic review %K Preferred Reporting Items for Systematic Reviews and Meta-Analyses %K PRISMA %D 2024 %7 28.3.2024 %9 Review %J JMIR Ment Health %G English %X Background: Suicide safety planning is an evidence-based approach used to help individuals identify strategies to keep themselves safe during a mental health crisis. This study systematically reviewed the literature focused on mobile health (mHealth) suicide safety planning apps. Objective: This study aims to evaluate the extent to which apps integrated components of the safety planning intervention (SPI), and if so, how these safety planning components were integrated into the design-based features of the apps. Methods: Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we systematically analyzed 14 peer-reviewed studies specific to mHealth apps for suicide safety planning. We conducted an analysis of the literature to evaluate how the apps incorporated SPI components and examined similarities and differences among the apps by conducting a comparative analysis of app features. An independent review of SPI components and app features was conducted by downloading the available apps. Results: Most of the mHealth apps (5/7, 71%) integrated SPI components and provided customizable features that expanded upon traditional paper-based safety planning processes. App design features were categorized into 5 themes, including interactive features, individualized user experiences, interface design, guidance and training, and privacy and sharing. All apps included access to community supports and revisable safety plans. Fewer mHealth apps (3/7, 43%) included interactive features, such as associating coping strategies with specific stressors. Most studies (10/14, 71%) examined the usability, feasibility, and acceptability of the safety planning mHealth apps. Usability findings were generally positive, as users often found these apps easy to use and visually appealing. In terms of feasibility, users preferred using mHealth apps during times of crisis, but the continuous use of the apps outside of crisis situations received less support. Few studies (4/14, 29%) examined the effectiveness of mHealth apps for suicide-related outcomes. Positive shifts in attitudes and desire to live, improved coping strategies, enhanced emotional stability, and a decrease in suicidal thoughts or self-harm behaviors were examined in these studies. Conclusions: Our study highlights the need for researchers, clinicians, and app designers to continue to work together to align evidence-based research on mHealth suicide safety planning apps with lessons learned for how to best deliver these technologies to end users. Our review brings to light mHealth suicide safety planning strategies needing further development and testing, such as lethal means guidance, collaborative safety planning, and the opportunity to embed more interactive features that leverage the advanced capabilities of technology to improve client outcomes as well as foster sustained user engagement beyond a crisis. Although preliminary evidence shows that these apps may help to mitigate suicide risk, clinical trials with larger sample sizes and more robust research designs are needed to validate their efficacy before the widespread adoption and use. %M 38546711 %R 10.2196/52763 %U https://mental.jmir.org/2024/1/e52763 %U https://doi.org/10.2196/52763 %U http://www.ncbi.nlm.nih.gov/pubmed/38546711 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e54287 %T Effectiveness of the Minder Mobile Mental Health and Substance Use Intervention for University Students: Randomized Controlled Trial %A Vereschagin,Melissa %A Wang,Angel Y %A Richardson,Chris G %A Xie,Hui %A Munthali,Richard J %A Hudec,Kristen L %A Leung,Calista %A Wojcik,Katharine D %A Munro,Lonna %A Halli,Priyanka %A Kessler,Ronald C %A Vigo,Daniel V %+ Department of Psychiatry, Faculty of Medicine, University of British Columbia, 2255 Wesbrook Mall, Vancouver, BC, V6T2A1, Canada, 1 6048228048, daniel.vigo@ubc.ca %K mental health %K substance use %K college students %K mobile interventions %K digital interventions %K randomized controlled trial %K mobile phone %D 2024 %7 27.3.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: University attendance represents a transition period for students that often coincides with the emergence of mental health and substance use challenges. Digital interventions have been identified as a promising means of supporting students due to their scalability, adaptability, and acceptability. Minder is a mental health and substance use mobile app that was codeveloped with university students. Objective: This study aims to examine the effectiveness of the Minder mobile app in improving mental health and substance use outcomes in a general population of university students. Methods: A 2-arm, parallel-assignment, single-blinded, 30-day randomized controlled trial was used to evaluate Minder using intention-to-treat analysis. In total, 1489 participants were recruited and randomly assigned to the intervention (n=743, 49.9%) or waitlist control (n=746, 50.1%) condition. The Minder app delivers evidence-based content through an automated chatbot and connects participants with services and university social groups. Participants are also assigned a trained peer coach to support them. The primary outcomes were measured through in-app self-assessments and included changes in general anxiety symptomology, depressive symptomology, and alcohol consumption risk measured using the 7-item General Anxiety Disorder scale, 9-item Patient Health Questionnaire, and US Alcohol Use Disorders Identification Test–Consumption Scale, respectively, from baseline to 30-day follow-up. Secondary outcomes included measures related to changes in the frequency of substance use (cannabis, alcohol, opioids, and nonmedical stimulants) and mental well-being. Generalized linear mixed-effects models were used to examine each outcome. Results: In total, 79.3% (589/743) of participants in the intervention group and 83% (619/746) of participants in the control group completed the follow-up survey. The intervention group had significantly greater average reductions in anxiety symptoms measured using the 7-item General Anxiety Disorder scale (adjusted group mean difference=−0.85, 95% CI −1.27 to −0.42; P<.001; Cohen d=−0.17) and depressive symptoms measured using the 9-item Patient Health Questionnaire (adjusted group mean difference=−0.63, 95% CI −1.08 to −0.17; P=.007; Cohen d=−0.11). A reduction in the US Alcohol Use Disorders Identification Test–Consumption Scale score among intervention participants was also observed, but it was not significant (P=.23). Statistically significant differences in favor of the intervention group were found for mental well-being and reductions in the frequency of cannabis use and typical number of drinks consumed. A total of 77.1% (573/743) of participants in the intervention group accessed at least 1 app component during the study period. Conclusions: In a general population sample of university students, the Minder app was effective in reducing symptoms of anxiety and depression, with provisional support for increasing mental well-being and reducing the frequency of cannabis and alcohol use. These findings highlight the potential ability of e-tools focused on prevention and early intervention to be integrated into existing university systems to support students’ needs. Trial Registration: ClinicalTrials.gov NCT05606601; https://clinicaltrials.gov/ct2/show/NCT05606601 International Registered Report Identifier (IRRID): RR2-10.2196/49364 %M 38536225 %R 10.2196/54287 %U https://www.jmir.org/2024/1/e54287 %U https://doi.org/10.2196/54287 %U http://www.ncbi.nlm.nih.gov/pubmed/38536225 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e54073 %T Adapting mHealth Interventions (PrEPmate and DOT Diary) to Support PrEP Retention in Care and Adherence Among English and Spanish-Speaking Men Who Have Sex With Men and Transgender Women in the United States: Formative Work and Pilot Randomized Trial %A Liu,Albert Y %A Alleyne,Cat-Dancing %A Doblecki-Lewis,Susanne %A Koester,Kimberly A %A Gonzalez,Rafael %A Vinson,Janie %A Scott,Hyman %A Buchbinder,Susan %A Torres,Thiago S %+ Bridge HIV, San Francisco Department of Public Health, 25 Van Ness Avenue, Suite 100, San Francisco, CA, 94102, United States, 1 628 217 7408, albert.liu@sfdph.org %K preexposure prophylaxis %K PrEP %K Spanish-speaking %K Latino %K transgender %K men who have sex with men %K mobile health %K mHealth %K HIV prevention %K HIV %K technology %K formative %K development %K mobile technology, mobile app %K text-messaging %K SMS %K app %K application %K USA %K United States %K health equity %K mHealth tool %K tool %K acceptability %K self-management %K pilot %K support %D 2024 %7 27.3.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: A growing number of mobile health (mHealth) technologies are being developed to support HIV preexposure prophylaxis (PrEP) adherence and persistence; however, most tools have focused on men who have sex with men (MSM), and few are available in Spanish. To maximize the potential impact of these tools in reducing gender and racial/ethnic disparities and promoting health equity, mHealth tools tailored to Spanish-speaking people and transgender women are critically needed. Objective: The aim of this study is to adapt and tailor 2 mHealth technologies, PrEPmate and DOT Diary, to support daily PrEP adherence and persistence among Spanish-speaking MSM and English- and Spanish-speaking transgender women and to evaluate the feasibility and acceptability of these tools. Methods: PrEPmate, an interactive, bidirectional, text messaging intervention that promotes personalized communication between PrEP users and providers, and DOT Diary, a mobile app that promotes self-management of PrEP use and sexual health through an integrated electronic pill-taking and sexual activity diary, were previously developed for English-speaking MSM. We conducted 3 focus groups with 15 English- and Spanish-speaking transgender women and MSM in San Francisco and Miami to culturally tailor these tools for these priority populations. We then conducted a 1-month technical pilot among 21 participants to assess the usability and acceptability of the adapted interventions and optimize the functionality of these tools. Results: Participants in focus groups liked the “human touch” of text messages in PrEPmate and thought it would be helpful for scheduling appointments and asking questions. They liked the daily reminder messages, especially the fun facts, gender affirmations, and transgender history topics. Participants recommended changes to tailor the language and messages for Spanish-speaking and transgender populations. For DOT Diary, participants liked the adherence tracking and protection level feedback and thought the calendar functions were easy to use. Based on participant recommendations, we tailored language within the app for Spanish-speaking MSM and transgender women, simplified the sexual diary, and added motivational badges. In the technical pilot of the refined tools, mean System Usability Scale scores were 81.2/100 for PrEPmate and 76.4/100 for DOT Diary (P=.48), falling in the “good” to “excellent” range, and mean Client Satisfaction Questionnaire scores were 28.6 and 28.3 for PrEPmate and DOT Diary, respectively (maximum possible score=32). Use of both tools was high over the 1-month pilot (average of 10.5 messages received from each participant for PrEPmate; average of 17.6 times accessing the DOT Diary app), indicating good feasibility for both tools. Conclusions: Using a user-centered design approach, we culturally tailored PrEPmate and DOT Diary to support daily PrEP use among Spanish-speaking MSM and English- and Spanish-speaking transgender women. Our positive findings in a technical pilot support further testing of these mHealth interventions in an upcoming comparative effectiveness trial. %M 38536232 %R 10.2196/54073 %U https://formative.jmir.org/2024/1/e54073 %U https://doi.org/10.2196/54073 %U http://www.ncbi.nlm.nih.gov/pubmed/38536232 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e44574 %T Digital Alcohol Interventions Could Be Part of the Societal Response to Harmful Consumption, but We Know Little About Their Long-Term Costs and Health Outcomes %A Ulfsdotter Gunnarsson,Katarina %A Henriksson,Martin %A Bendtsen,Marcus %+ Department of Health, Medicine, and Caring Sciences, Linköping University, Campus US, Linköping, 58183, Sweden, 46 13281000, katarina.ulfsdotter.gunnarsson@liu.se %K alcohol %K health economics %K telemedicine %K psychological harm %K eHealth %K digital intervention %K decision-making %D 2024 %7 27.3.2024 %9 Viewpoint %J J Med Internet Res %G English %X Alcohol consumption causes both physical and psychological harm and is a leading risk factor for noncommunicable diseases. Digital alcohol interventions have been found to support those looking for help by giving them tools for change. However, whether digital interventions can help tackle the long-term societal consequences of harmful alcohol consumption in a cost-effective manner has not been adequately evaluated. In this Viewpoint, we propose that studies of digital alcohol interventions rarely evaluate the consequences of wider dissemination of the intervention under study, and that when they do, they do not take advantage of modeling techniques that allow for appropriately studying consequences over a longer time horizon than the study period when the intervention is tested. We argue that to help decision-makers to prioritize resources for research and dissemination, it is important to model long-term costs and health outcomes. Further, this type of modeling gives important insights into the context in which interventions are studied and highlights where more research is required and where sufficient evidence is available. The viewpoint therefore invites the researcher not only to reflect on which interventions to study but also how to evaluate their long-term consequences. %M 38536228 %R 10.2196/44574 %U https://www.jmir.org/2024/1/e44574 %U https://doi.org/10.2196/44574 %U http://www.ncbi.nlm.nih.gov/pubmed/38536228 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 10 %N %P e43554 %T The Impact of Wireless Emergency Alerts on a Floating Population in Seoul, South Korea: Panel Data Analysis %A Yoon,Sungwook %A Lim,Hyungsoo %A Park,Sungho %+ Business School, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul, 08826, Republic of Korea, 82 2 880 6949, spark104@snu.ac.kr %K COVID-19 %K empirical identification %K floating population %K social distancing %K wireless emergency alert %D 2024 %7 25.3.2024 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: Wireless emergency alerts (WEAs), which deliver disaster information directly to individuals’ mobile phones, have been widely used to provide information related to COVID-19 and to encourage compliance with social distancing guidelines during the COVID-19 pandemic. The floating population refers to the number of people temporarily staying in a specific area, and this demographic data can be a useful indicator to understand the level of social distancing people are complying with during the COVID-19 pandemic. Objective: This study aimed to empirically analyze the impact of WEAs on the floating population where WEAs were transmitted in the early stages of the COVID-19 pandemic. As most WEA messages focus on compliance with the government’s social distancing guidelines, one of the goals of transmitting WEAs during the COVID-19 pandemic is to control the floating population at an appropriate level. Methods: We investigated the empirical impact of WEAs on the floating population across 25 districts in Seoul by estimating a panel regression model at the district-hour level with a series of fixed effects. The main independent variables were the number of instant WEAs, the daily cumulative number of WEAs, the total cumulative number of WEAs, and information extracted from WEAs by natural language processing at the district-hour level. The data set provided a highly informative empirical setting as WEAs were sent by different local governments with various identifiable district-hour–level data. Results: The estimates of the impact of WEAs on the floating population were significantly negative (–0.013, P=.02 to –0.014, P=.01) across all specifications, implying that an additional WEA issuance reduced the floating population by 1.3% (=100(1–e–0.013)) to 1.4% (=100(1–e–0.014)). Although the coefficients of DCN (the daily cumulative number of WEAs) were also negative (–0.0034, P=.34 to –0.0052, P=.15) across all models, they were not significant. The impact of WEAs on the floating population doubled (–0.025, P=.02 to –0.033, P=.005) when the first 82 days of observations were used as subsamples to reduce the possibility of people blocking WEAs. Conclusions: Our results suggest that issuing WEAs and distributing information related to COVID-19 to a specific district was associated with a decrease in the floating population of that district. Furthermore, among the various types of information in the WEAs, location information was the only significant type of information that was related to a decrease in the floating population. This study makes important contributions. First, this study measured the impact of WEAs in a highly informative empirical setting. Second, this study adds to the existing literature on the mechanisms by which WEAs can affect public response. Lastly, this study has important implications for making optimal WEAs and suggests that location information should be included. %M 38526536 %R 10.2196/43554 %U https://publichealth.jmir.org/2024/1/e43554 %U https://doi.org/10.2196/43554 %U http://www.ncbi.nlm.nih.gov/pubmed/38526536 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e49133 %T Development of Therapeutic Alliance and Social Presence in a Digital Intervention for Pediatric Concussion: Qualitative Exploratory Study %A O'Kane,Kiarah M K %A Otamendi,Thalia %A Silverberg,Noah D %A Choi,Esther %A Sicard,Veronik %A Zemek,Roger %A Healey,Katherine %A Brown,Olivier %A Butterfield,Lauren %A Smith,Andra %A Goldfield,Gary %A Kardish,Rachel %A Saab,Bechara J %A Ledoux,Andrée-Anne %A Cairncross,Molly %+ Department of Psychology, Simon Fraser University, Robert C. Brown Hall 7321, 8888 University Drive, Burnaby, BC, V5A 1S6, Canada, 1 778 782 7458, molly_cairncross@sfu.ca %K adolescent %K concussion %K digital therapeutics %K eHealth %K mHealth %K mindfulness %K mobile health %K social presence %K working alliance %D 2024 %7 22.3.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Despite the promising benefits of self-guided digital interventions for adolescents recovering from concussion, attrition rates for such interventions are high. Evidence suggests that adults can develop therapeutic alliance with self-guided digital interventions, which is in turn associated with intervention engagement. However, no research has examined whether adolescents develop therapeutic alliance with self-guided digital interventions and what factors are important to its development. Additionally, social presence—the extent to which digital encounters feel like they are occurring in person—may be another relevant factor to understanding the nature of the connection between adolescents and a self-guided digital intervention, though this has yet to be explored. Objective: This qualitative study explored the extent to which adolescents recovering from concussion developed therapeutic alliance and social presence during their use of a self-guided digital mindfulness-based intervention. Additionally, this study aimed to determine factors important to adolescents’ development of therapeutic alliance and social presence with the intervention. Methods: Adolescents aged between 12 and 17.99 years who sustained a concussion were recruited from 2 sites: a pediatric emergency department up to 48 hours after a concussion and a tertiary care clinic over 1 month following a concussion to capture adolescents who had both acute and persisting symptoms after concussion. Participants (N=10) completed a 4-week mindfulness-based intervention delivered through a smartphone app. Within the app, participants listened to audio recordings of mindfulness guides (voice actors) narrating psychoeducation and mindfulness practices. At 4 weeks, participants completed questionnaires and a semistructured interview exploring their experience of therapeutic alliance and social presence with the mindfulness guides in the intervention. Results: Themes identified within the qualitative results revealed that participants developed therapeutic alliance and social presence by “developing a genuine connection” with their mindfulness guides and “sensing real people.” Particularly important to the development of therapeutic alliance and social presence were the mindfulness guides’ “personal backgrounds and voices,” such that participants felt more connected to the guides by knowing information about them and through the guides’ calm tone of voice in audio recordings. Quantitative findings supported qualitative results; participants’ average score for therapeutic alliance was far above the scale midpoint, while the mixed results for social presence measures aligned with qualitative findings that participants felt that the mindfulness guides seemed real but not quite as real as an in-person connection would. Conclusions: Our data suggest that adolescents can develop therapeutic alliance and social presence when using digital interventions with no direct human contact. Adolescents’ development of therapeutic alliance and social presence with self-guided digital interventions can be bolstered by increasing human-like qualities (eg, real voices) within interventions. Maximizing therapeutic alliance and social presence may be a promising way to reduce attrition in self-guided digital interventions while providing accessible treatment. %M 38517472 %R 10.2196/49133 %U https://formative.jmir.org/2024/1/e49133 %U https://doi.org/10.2196/49133 %U http://www.ncbi.nlm.nih.gov/pubmed/38517472 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 13 %N %P e53054 %T Effectiveness of a Smartphone App to Promote Physical Activity Among Persons With Type 2 Diabetes: Randomized Controlled Trial %A Bonn,Stephanie E %A Hummel,Madeleine %A Peveri,Giulia %A Eke,Helén %A Alexandrou,Christina %A Bellocco,Rino %A Löf,Marie %A Trolle Lagerros,Ylva %+ Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Maria Aspmans gata 30A, Stockholm, 171 64, Sweden, 46 8 517 791, stephanie.bonn@ki.se %K behavior change %K exercise %K intervention %K mHealth %K smartphone app %K self-monitoring %D 2024 %7 21.3.2024 %9 Original Paper %J Interact J Med Res %G English %X Background: Physical activity is well known to have beneficial effects on glycemic control and to reduce risk factors for cardiovascular disease in persons with type 2 diabetes. Yet, successful implementation of lifestyle interventions targeting physical activity in primary care has shown to be difficult. Smartphone apps may provide useful tools to support physical activity. The DiaCert app was specifically designed for integration into primary care and is an automated mobile health (mHealth) solution promoting daily walking. Objective: This study aimed to investigate the effect of a 3-month-long intervention promoting physical activity through the use of the DiaCert app among persons with type 2 diabetes in Sweden. Our primary objective was to assess the effect on moderate to vigorous physical activity (MVPA) at 3 months of follow-up. Our secondary objective was to assess the effect on MVPA at 6 months of follow-up and on BMI, waist circumference, hemoglobin A1c, blood lipids, and blood pressure at 3 and 6 months of follow-up. Methods: We recruited men and women with type 2 diabetes from 5 primary health care centers and 1 specialized center. Participants were randomized 1:1 to the intervention or control group. The intervention group was administered standard care and access to the DiaCert app at baseline and 3 months onward. The control group received standard care only. Outcomes of objectively measured physical activity using accelerometers, BMI, waist circumference, biomarkers, and blood pressure were assessed at baseline and follow-ups. Linear mixed models were used to assess differences in outcomes between the groups. Results: A total of 181 study participants, 65.7% (119/181) men and 34.3% (62/181) women, were recruited into the study and randomized to the intervention (n=93) or control group (n=88). The participants’ mean age and BMI were 60.0 (SD 11.4) years and 30.4 (SD 5.3) kg/m2, respectively. We found no significant effect of the intervention (group by time interaction) on MVPA at either the 3-month (β=1.51, 95% CI –5.53 to 8.55) or the 6-month (β=–3.53, 95% CI –10.97 to 3.92) follow-up. We found no effect on any of the secondary outcomes at follow-ups, except for a significant effect on BMI at 6 months (β=0.52, 95% CI 0.20 to 0.84). However, mean BMI did not differ between the groups at the 6-month follow-up. Conclusions: We found no evidence that persons with type 2 diabetes being randomized to use an app promoting daily walking increased their levels of MVPA at 3 or 6 months’ follow-up compared with controls receiving standard care. The effect of the app on BMI was unclear, and we found nothing to support an effect on secondary outcomes. Further research is needed to determine what type of mHealth intervention could be effective to increase physical activity among persons with type 2 diabetes. Trial Registration: ClinicalTrials.gov NCT03053336; https://clinicaltrials.gov/study/NCT03053336 %M 38512333 %R 10.2196/53054 %U https://www.i-jmr.org/2024/1/e53054 %U https://doi.org/10.2196/53054 %U http://www.ncbi.nlm.nih.gov/pubmed/38512333 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e50931 %T Assessing Knowledge, Competence, and Performance Following Web-Based Education on Early Breast Cancer Management: Health Care Professional Questionnaire Study and Anonymized Patient Records Analysis %A Gnant,Michael %A Abdullah,Khatijah Lim %A Boyle,Frances %A Huang,Chiun-Sheng %A Bickford,Katie %A Neunie,Sola %A Noble,Alexander %A Nunn,Anne %A Sproat,Caroline %A Harbeck,Nadia %A Barrios,Carlos %+ Comprehensive Cancer Center, Medical University of Vienna, Spitalgasse 23, BT86/E01, Vienna, 1090, Austria, 43 1 40160 35602, mgnant@icloud.com %K continuing medical education %K early breast cancer %K performance %K risk stratification %K shared decision-making %D 2024 %7 21.3.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Web-based learning activities are key components of continuing medical education (CME) for health care professionals (HCPs). However, the published outcomes of web-based educational interventions for early breast cancer (EBC) are limited. Objective: This study aims to objectively assess knowledge, competence, and performance among HCPs following participation in 2 EBC-focused CME activities and to identify the remaining educational gaps. Methods: We developed 2 CME-accredited web-based educational activities addressing high-risk EBC, including integration of shared decision-making to optimize patient care (touchMDT) and stratification for early identification of high-risk patients and novel treatment strategies (touchPANEL DISCUSSION). Knowledge, competence, and performance were assessed before and after the activities against an expanded outcomes framework (levels 1-5) using self-reported questionnaires and an analysis of anonymized data extracted from patient records. Results: Six months after the launch of the activity, 7047 and 8989 HCP participants engaged with touchMDT and touchPANEL DISCUSSION, respectively. The overall satisfaction was 82% (a total score of 20.6 out of 25) for the touchMDT and 88% (a total score of 21.9 out of 25) for the touchPANEL DISCUSSION. For the evaluation of knowledge and competence (50 respondents before the activity and 50 learners after the activity), there was a significant increase in the mean number of correctly answered questions from pre- to postactivity (touchMDT: median 4.0, IQR 3.0-5.0 to median 5.5, IQR 4.0-7.0; mean 4.00, SD 1.39 to mean 5.30, SD 1.56 and touchPANEL DISCUSSION: median 4.0, IQR 4.0-5.0 to median 6.0, IQR 5.0-7.0; mean 4.32, SD 1.30 to mean 5.88, SD 1.49; both P<.001). A significant improvement in self-reported performance (50 respondents before the activity and 50 learners after the activity) was observed in a combined analysis of both activities (median 3.0, IQR 2.0-3.0 to median 4.0, IQR 3.0-5.0; mean 2.82, SD 1.08 to mean 4.16, SD 1.45; P<.001). Patient record analysis (50 respondents before the activity and 50 learners after the activity) showed that the HCPs used a range of measures to determine EBC recurrence risk and revealed no significant differences in adjuvant therapies used before and after the activity (P=.97 and P>.99 for Ki-67 <20% and Ki-67 ≥20% tumors, respectively). The remaining educational gaps included strategies for implementing shared decision-making in clinical practice and the use of genetic and biomarker testing to guide treatment selection. Conclusions: Brief, web-based CME activities on EBC were associated with an improvement in HCP knowledge, competence, and self-reported performance and can help identify unmet needs to inform the design of future CME activities. %M 38512328 %R 10.2196/50931 %U https://formative.jmir.org/2024/1/e50931 %U https://doi.org/10.2196/50931 %U http://www.ncbi.nlm.nih.gov/pubmed/38512328 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55960 %T A Web-Based Physical Activity Promotion Intervention for Inactive Parent-Child Dyads: Protocol for a Randomized Controlled Trial %A Phipps,Daniel %A Green,Weldon Thomas %A Aho,Reetta %A Kettunen,Eeva %A Biddle,Stuart %A Hamilton,Kyra %A Laukkanen,Arto %A Aunola,Kaisa %A Chan,Derwin King %A Hankonen,Nelli %A Hassandra,Mary %A Kärkkäinen,Tommi %A Kykyri,Virpi-Liisa %A Polet,Juho %A Rhodes,Ryan %A Ruiz,Montse C %A Sääkslahti,Arja %A Schneider,Jekaterina %A Toivonen,Hanna-Mari %A Lintunen,Taru %A Hagger,Martin %A Knittle,Keegan %+ Health Sciences Research Institute, University of California - Merced, 5200 North Lake Rd, Merced, CA, 95343, United States, 1 (209) 228 4400, mhagger@ucmerced.edu %K dyadic behavior change %K family behavior change %K intervention %K physical activity %K theory of planned behavior %D 2024 %7 21.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Low levels of physical activity are associated with numerous adverse health outcomes, yet sedentary lifestyles are common among both children and adults. Physical activity levels tend to decline steeply among children aged between 8 and 12 years, even though children’s behavioral patterns are largely governed by familial structures. Similarly, parents’ activity levels have been generally reported as lower than those of nonparents of comparable age. For this reason, family-based physical activity promotion interventions are a potentially valuable and relatively underresearched method for mitigating physical activity declines as children develop into adolescents and for increasing physical activity in parents. Objective: This study aims to assess the efficacy, feasibility, and acceptability of a novel theory-based web-based physical activity promotion intervention among parent-child dyads in Finland who do not meet physical activity recommendations at baseline. Methods: Participants (target N=254) will be recruited from the general population using a panel company and advertisements on social media and randomly assigned to either an immediate intervention group or a waitlist control group. The intervention consists of 4 web-based group workshops over the course of 10 weeks, web-based tasks and resources, and a social support chat group. Data on physical activity behavior and constructs from the integrated behavior change model will be collected through self-report surveys assessing physical activity, autonomy support, autonomous motivation, attitude, subjective norm, perceived behavioral control, intention, self-monitoring, habit, and accelerometer measurements at baseline, post intervention, and 3 months post intervention. Exit interviews with participants will assess the feasibility and acceptability of the intervention procedures. Results: This study will reveal whether the intervention changes leisure-time physical activity among intervention participants relative to the control group and will examine the intervention’s effects on important theoretical predictors of physical activity. It will also yield data that can be used to refine intervention materials and inform further implementation. Trial recruitment commenced in September 2023, and data collection should be completed by December 2024. Conclusions: The planned intervention has potential implications for both theory and practice. Practically, the use of an entirely web-based intervention may have scalable future uses for improving physical activity in 2 key populations, while also potentially informing on the value of dyadic, family-based strategies for encouraging an active lifestyle as an alternative to strategies that target either parents or children independently. Further, by assessing change in psychological constructs alongside potential change in behavior, the intervention also allows for important tests of theory regarding which constructs are most linked to favorable behavior change outcomes. Trial Registration: ClinicalTrials.gov NCT06070038; https://clinicaltrials.gov/study/NCT06070038 International Registered Report Identifier (IRRID): DERR1-10.2196/55960 %M 38512336 %R 10.2196/55960 %U https://www.researchprotocols.org/2024/1/e55960 %U https://doi.org/10.2196/55960 %U http://www.ncbi.nlm.nih.gov/pubmed/38512336 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53294 %T Understanding Heterogeneity in Individual Responses to Digital Lifestyle Intervention Through Self-Monitoring Adherence Trajectories in Adults With Overweight or Obesity: Secondary Analysis of a 6-Month Randomized Controlled Trial %A Li,Shiyu %A Du,Yan %A Miao,Hongyu %A Sharma,Kumar %A Li,Chengdong %A Yin,Zenong %A Brimhall,Bradley %A Wang,Jing %+ College of Nursing, Florida State University, Vivian M Duxbury Hall, 98 Varsity Way, Tallahassee, FL, 31306, United States, 1 850 644 3299, jingwang@nursing.fsu.edu %K self-monitoring %K adherence %K weight loss %K digital technology %K behavior change %K group-based trajectory modeling %K precision health %K mobile phone %D 2024 %7 20.3.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Achieving clinically significant weight loss through lifestyle interventions for obesity management is challenging for most individuals. Improving intervention effectiveness involves early identification of intervention nonresponders and providing them with timely, tailored interventions. Early and frequent self-monitoring (SM) adherence predicts later weight loss success, making it a potential indicator for identifying nonresponders in the initial phase. Objective: This study aims to identify clinically meaningful participant subgroups based on longitudinal adherence to SM of diet, activity, and weight over 6 months as well as psychological predictors of participant subgroups from a self-determination theory (SDT) perspective. Methods: This was a secondary data analysis of a 6-month digital lifestyle intervention for adults with overweight or obesity. The participants were instructed to perform daily SM on 3 targets: diet, activity, and weight. Data from 50 participants (mean age: 53.0, SD 12.6 y) were analyzed. Group-based multitrajectory modeling was performed to identify subgroups with distinct trajectories of SM adherence across the 3 SM targets. Differences between subgroups were examined for changes in clinical outcomes (ie, body weight, hemoglobin A1c) and SDT constructs (ie, eating-related autonomous motivation and perceived competence for diet) over 6 months using linear mixed models. Results: Two distinct SM trajectory subgroups emerged: the Lower SM group (21/50, 42%), characterized by all-around low and rapidly declining SM, and the Higher SM group (29/50, 58%), characterized by moderate and declining diet and weight SM with high activity SM. Since week 2, participants in the Lower SM group exhibited significantly lower levels of diet (P=.003), activity (P=.002), and weight SM (P=.02) compared with the Higher SM group. In terms of clinical outcomes, the Higher SM group achieved a significant reduction in body weight (estimate: −6.06, SD 0.87 kg; P<.001) and hemoglobin A1c (estimate: −0.38, SD 0.11%; P=.02), whereas the Lower SM group exhibited no improvements. For SDT constructs, both groups maintained high levels of autonomous motivation for over 6 months. However, the Lower SM group experienced a significant decline in perceived competence (P=.005) compared with the Higher SM group, which maintained a high level of perceived competence throughout the intervention (P=.09). Conclusions: The presence of the Lower SM group highlights the value of using longitudinal SM adherence trajectories as an intervention response indicator. Future adaptive trials should identify nonresponders within the initial 2 weeks based on their SM adherence and integrate intervention strategies to enhance perceived competence in diet to benefit nonresponders. Trial Registration: ClinicalTrials.gov NCT05071287; https://clinicaltrials.gov/study/NCT05071287 International Registered Report Identifier (IRRID): RR2-10.1016/j.cct.2022.106845 %M 38506903 %R 10.2196/53294 %U https://www.jmir.org/2024/1/e53294 %U https://doi.org/10.2196/53294 %U http://www.ncbi.nlm.nih.gov/pubmed/38506903 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e49857 %T An Ecological Mobile Momentary Intervention to Support Dynamic Goal Pursuit: Feasibility and Acceptability Study %A O'Driscoll,Ciarán %A Singh,Aneesha %A Chichua,Iya %A Clodic,Joachim %A Desai,Anjali %A Nikolova,Dara %A Yap,Alex Jie %A Zhou,Irene %A Pilling,Stephen %+ CORE Data Lab, Centre for Outcomes Research and Effectiveness, University College London, Gower Street, London, WC1E 6BT, United Kingdom, 44 207679 1897, c.odriscoll@ucl.ac.uk %K goal pursuit %K ecological momentary intervention %K ecological momentary assessment %K mood %K dynamics %K network analysis %K MCII %K COM-B %K support %K pilot study %K training %K feasibility %K acceptability %K self-monitoring %K implementation %K psychological %K effectiveness %D 2024 %7 20.3.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Individuals can experience difficulties pursuing their goals amid multiple competing priorities in their environment. Effective goal dynamics require flexible and generalizable pursuit skills. Supporting successful goal pursuit requires a perpetually adapting intervention responsive to internal states. Objective: The purpose of this study was to (1) develop a flexible intervention that can adapt to an individual’s changing short to medium-term goals and be applied to their daily life and (2) examine the feasibility and acceptability of the just-in-time adaptive intervention for goal pursuit. Methods: This study involved 3 iterations to test and systematically enhance all aspects of the intervention. During the pilot phase, 73 participants engaged in an ecological momentary assessment (EMA) over 1 month. After week 1, they attended an intervention training session and received just-in-time intervention prompts during the following 3 weeks. The training employed the Capability, Opportunity, Motivation, and Behavior (COM-B) framework for goal setting, along with mental contrasting with implementation intentions (MCII). Subsequent prompts, triggered by variability in goal pursuit, guided the participants to engage in MCII in relation to their current goal. We evaluated feasibility and acceptability, efficacy, and individual change processes by combining intensive (single-case experimental design) and extensive methods. Results: The results suggest that the digital intervention was feasible and acceptable to participants. Compliance with the intervention was high (n=63, 86%). The participants endorsed high acceptability ratings relating to both the study procedures and the intervention. All participants (N=73, 100%) demonstrated significant improvements in goal pursuit with an average difference of 0.495 units in the outcome (P<.001). The results of the dynamic network modeling suggest that self-monitoring behavior (EMA) and implementing the MCII strategy may aid in goal reprioritization, where goal pursuit itself is a driver of further goal pursuit. Conclusions: This pilot study demonstrated the feasibility and acceptability of a just-in-time adaptive intervention among a nonclinical adult sample. This intervention used self-monitoring of behavior, the COM-B framework, and MCII strategies to improve dynamic goal pursuit. It was delivered via an Ecological Momentary Intervention (EMI) procedure. Future research should consider the utility of this approach as an additional intervention element within psychological interventions to improve goal pursuit. Sustaining goal pursuit throughout interventions is central to their effectiveness and warrants further evaluation. %M 38506904 %R 10.2196/49857 %U https://formative.jmir.org/2024/1/e49857 %U https://doi.org/10.2196/49857 %U http://www.ncbi.nlm.nih.gov/pubmed/38506904 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54342 %T Efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) in Individuals With Chronic Pain and Opioid Use Disorder: Protocol for a Randomized Clinical Trial of a Digital Cognitive Behavioral Treatment %A MacLean,R Ross %A Ankawi,Brett %A Driscoll,Mary A %A Gordon,Melissa A %A Frankforter,Tami L %A Nich,Charla %A Szollosy,Sara K %A Loya,Jennifer M %A Brito,Larissa %A Ribeiro,Margaridha I P %A Edmond,Sara N %A Becker,William C %A Martino,Steve %A Sofuoglu,Mehmet %A Heapy,Alicia A %+ VA Connecticut Healthcare System, 950 Campbell Ave, West Haven, CT, 06516, United States, 1 2039325711, ross.maclean@yale.edu %K chronic pain %K digital treatment %K medications for opioid use disorder %K methadone %K opioid use disorder %D 2024 %7 20.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic pain is common among individuals with opioid use disorder (OUD) who are maintained on medications for OUD (MOUD; eg, buprenorphine or methadone). Chronic pain is associated with worse retention and higher levels of substance use. Treatment of individuals with chronic pain receiving MOUD can be challenging due to their increased clinical complexity. Given the acute and growing nature of the opioid crisis, MOUD is increasingly offered in a wide range of settings, where high-quality, clinician-delivered, empirically validated behavioral treatment for chronic pain may not be available. Therefore, digital treatments that support patient self-management of chronic pain and OUD have the potential for wider implementation to fill this gap. Objective: This study aims to evaluate the efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT), an interactive digital treatment program with asynchronous coach feedback, compared to treatment as usual (TAU) in individuals with chronic pain and OUD receiving MOUD. Methods: Adult participants (n=160) receiving MOUD and reporting bothersome or high-impact chronic pain will be recruited from outpatient opioid treatment programs in Connecticut (United States) and randomized 1:1 to either IMPACT+TAU or TAU only. Participants randomized to IMPACT+TAU will complete an interactive digital treatment that includes 9 modules promoting training in pain and addiction coping skills and a progressive walking program. The program is augmented with a weekly personalized voice message from a trained coach based on daily participant-reported pain intensity and interference, craving to use opioids, sleep quality, daily steps, pain self-efficacy, MOUD adherence, and engagement with IMPACT collected through digital surveys. Outcomes will be assessed at 3, 6, and 9 months post randomization. The primary outcome is MOUD retention at 3 months post randomization (ie, post treatment). Secondary outcomes include pain interference, physical functioning, MOUD adherence, substance use, craving, pain intensity, sleep disturbance, pain catastrophizing, and pain self-efficacy. Semistructured qualitative interviews with study participants (n=34) randomized to IMPACT (completers and noncompleters) will be conducted to evaluate the usability and quality of the program and its outcomes. Results: The study has received institutional review board approval and began recruitment at 1 site in July 2022. Recruitment at a second site started in January 2023, with a third and final site anticipated to begin recruitment in January 2024. Data collection is expected to continue through June 2025. Conclusions: Establishing efficacy for a digital treatment for addiction and chronic pain that can be integrated into MOUD clinics will provide options for individuals with OUD, which reduce barriers to behavioral treatment. Participant feedback on the intervention will inform updates or modifications to improve engagement and efficacy. Trial Registration: ClinicalTrials.gov NCT05204576; https://clinicaltrials.gov/ct2/show/NCT05204576 International Registered Report Identifier (IRRID): DERR1-10.2196/54342 %M 38506917 %R 10.2196/54342 %U https://www.researchprotocols.org/2024/1/e54342 %U https://doi.org/10.2196/54342 %U http://www.ncbi.nlm.nih.gov/pubmed/38506917 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e51667 %T Using a Rapid Learning Health System for Stratified Care in Emerging Adult Mental Health Services: Protocol for the Implementation of Patient-Reported Outcome Measures %A Dimitropoulos,Gina %A Lindenbach,David %A Potestio,Melissa %A Mogan,Tom %A Richardson,Amanda %A Anderson,Alida %A Heintz,Madison %A Moskovic,Karen %A Gondziola,Jason %A Bradley,Jessica %A LaMonica,Haley M %A Iorfino,Frank %A Hickie,Ian %A Patten,Scott B %A Arnold,Paul D %+ Mathison Centre for Mental Health & Education, University of Calgary, 3280 Hospital Drive NW, Calgary, AB, T2N 4Z6, Canada, 1 403 210 6464, gdimit@ucalgary.ca %K learning health system %K stratified care %K patient-reported outcome measures %K mental health %K emerging adults %K protocol papers %K pragmatic clinical trials %K e-mental health %K RE-AIM %K Reach, Effectiveness, Adoption, Implementation, and Maintenance %K implementation science %K adult %K health system %K stratified care %K treatment %K implementation %K acceptability %K measurement-based care %D 2024 %7 20.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Mental illness among emerging adults is often difficult to ameliorate due to fluctuating symptoms and heterogeneity. Recently, innovative approaches have been developed to improve mental health care for emerging adults, including (1) implementing patient-reported outcome measures (PROMs) to assess illness severity and inform stratified care to assign emerging adults to a treatment modality commensurate with their level of impairment and (2) implementing a rapid learning health system in which data are continuously collected and analyzed to generate new insights, which are then translated to clinical practice, including collaboration among clients, health care providers, and researchers to co-design and coevaluate assessment and treatment strategies. Objective: The aim of the study is to determine the feasibility and acceptability of implementing a rapid learning health system to enable a measurement-based, stratified care treatment strategy for emerging adults. Methods: This study takes place at a specialty clinic serving emerging adults (age 16-24 years) in Calgary, Canada, and involves extensive collaboration among researchers, providers, and youth. The study design includes six phases: (1) developing a transdiagnostic platform for PROMs, (2) designing an initial stratified care model, (3) combining the implementation of PROMs with stratified care, (4) evaluating outcomes and disseminating results, (5) modification of stratified care based on data derived from PROMs, and (6) spread and scale to new sites. Qualitative and quantitative feedback will be collected from health care providers and youth throughout the implementation process. These data will be analyzed at regular intervals and used to modify the way future services are delivered. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework is used to organize and evaluate implementation according to 3 key objectives: improving treatment selection, reducing average wait time and treatment duration, and increasing the value of services. Results: This project was funded through a program grant running from 2021 to 2026. Ethics approval for this study was received in February 2023. Presently, we have developed a system of PROMs and organized clinical services into strata of care. We will soon begin using PROMs to assign clients to a stratum of care and using feedback from youth and clinicians to understand how to improve experiences and outcomes. Conclusions: This study has key implications for researchers and clinicians looking to understand how to customize emerging adult mental health services to improve the quality of care and satisfaction with care. This study has significant implications for mental health care systems as part of a movement toward value-based health care. International Registered Report Identifier (IRRID): PRR1-10.2196/51667 %M 38506921 %R 10.2196/51667 %U https://www.researchprotocols.org/2024/1/e51667 %U https://doi.org/10.2196/51667 %U http://www.ncbi.nlm.nih.gov/pubmed/38506921 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53651 %T The Use of Mobile Technologies to Promote Physical Activity and Reduce Sedentary Behaviors in the Middle East and North Africa Region: Systematic Review and Meta-Analysis %A Tong,Huong Ly %A Alnasser,Aroub %A Alshahrani,Najim Z %A Bawaked,Rowaedh A %A AlAhmed,Reem %A Alsukait,Reem F %A Rakic,Severin %A Cetinkaya,Volkan %A Al-Hazzaa,Hazzaa M %A Alqahtani,Saleh A %+ Cultural and Indigenous Research Centre Australia, 16 Eveleight St, Redfern, 2016, Australia, 61 28585 ext 1311, lytong.2208@gmail.com %K mobile apps %K fitness trackers %K SMS %K SMS text messaging %K physical activity %K exercise %K sedentary behavior %K Middle East %K Africa, Northern %K movement %K physical inactivity %K smartphone %K mobile phone %K mobile health %K mHealth %K digital health %K behavior change %K intervention %D 2024 %7 19.3.2024 %9 Review %J J Med Internet Res %G English %X Background: The Middle East and North Africa (MENA) region faces unique challenges in promoting physical activity and reducing sedentary behaviors, as the prevalence of insufficient physical activity is higher than the global average. Mobile technologies present a promising approach to delivering behavioral interventions; however, little is known about the effectiveness and user perspectives on these technologies in the MENA region. Objective: This study aims to evaluate the effectiveness of mobile interventions targeting physical activity and sedentary behaviors in the MENA region and explore users’ perspectives on these interventions as well as any other outcomes that might influence users’ adoption and use of mobile technologies (eg, appropriateness and cultural fit). Methods: A systematic search of 5 databases (MEDLINE, Embase, CINAHL, Scopus, and Global Index Medicus) was performed. Any primary studies (participants of all ages regardless of medical condition) conducted in the MENA region that investigated the use of mobile technologies and reported any measures of physical activity, sedentary behaviors, or user perceptions were included. We conducted a narrative synthesis of all studies and a meta-analysis of randomized controlled trials (RCTs). The Cochrane risk-of-bias tool was used to assess the quality of the included RCTs; quality assessment of the rest of the included studies was completed using the relevant Joanna Briggs Institute critical appraisal tools. Results: In total, 27 articles describing 22 interventions (n=10, 37% RCTs) and 4 (15%) nonexperimental studies were included (n=6141, 46% women). Half (11/22, 50%) of the interventions included mobile apps, whereas the other half examined SMS. The main app functions were goal setting and self-monitoring of activity, whereas SMS interventions were primarily used to deliver educational content. Users in experimental studies described several benefits of the interventions (eg, gaining knowledge and receiving reminders to be active). Engagement with the interventions was poorly reported; few studies (8/27, 30%) examined users’ perspectives on the appropriateness or cultural fit of the interventions. Nonexperimental studies examined users’ perspectives on mobile apps and fitness trackers, reporting several barriers to their use, such as perceived lack of usefulness, loss of interest, and technical issues. The meta-analysis of RCTs showed a positive effect of mobile interventions on physical activity outcomes (standardized mean difference=0.45, 95% CI 0.17-0.73); several sensitivity analyses showed similar results. The trim-and-fill method showed possible publication bias. Only 20% (2/10) of the RCTs measured sedentary behaviors; both reported positive changes. Conclusions: The use of mobile interventions for physical activity and sedentary behaviors in the MENA region is in its early stages, with preliminary evidence of effectiveness. Policy makers and researchers should invest in high-quality studies to evaluate long-term effectiveness, intervention engagement, and implementation outcomes, which can inform the design of culturally and socially appropriate interventions for countries in the MENA region. Trial Registration: PROSPERO CRD42023392699; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=392699 %M 38502160 %R 10.2196/53651 %U https://www.jmir.org/2024/1/e53651 %U https://doi.org/10.2196/53651 %U http://www.ncbi.nlm.nih.gov/pubmed/38502160 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e51108 %T Long-Term Effectiveness of a Multi-Strategy Choice Architecture Intervention in Increasing Healthy Food Choices of High-School Students From Online Canteens (Click & Crunch High Schools): Cluster Randomized Controlled Trial %A Delaney,Tessa %A Jackson,Jacklyn %A Lecathelinais,Christophe %A Clinton-McHarg,Tara %A Lamont,Hannah %A Yoong,Sze Lin %A Wolfenden,Luke %A Sutherland,Rachel %A Wyse,Rebecca %+ School of Medicine and Public Health, University of Newcastle, Locked Bag 10, Wallsend, 2287, Australia, 61 294617441, Tessa.Delaney@health.nsw.gov.au %K randomized controlled trial %K web-based ordering systems %K ordering %K menu %K menus %K prompt %K prompts %K prompting %K nudge %K nudges %K behavior change %K behaviour change %K digital intervention %K lunch %K school %K menu labelling %K behavioral economics %K secondary school %K meal delivery apps %K public health nutrition %K meal %K meals %K nutrition %K nutritional %K diet %K eating %K food %K schools %K student %K students %K RCT %K randomized %K controlled trial %K controlled trials %K purchase %K purchasing %K canteen %K canteens %K choice %K choices %K architecture %D 2024 %7 19.3.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: School canteens are a recommended setting to influence adolescent nutrition due to their scope to improve student food choices. Online lunch ordering systems (“online canteens”) are increasingly used and represent attractive infrastructure to implement choice architecture interventions that nudge users toward healthier food choices. A recent cluster randomized controlled trial demonstrated the short-term effectiveness (2-month follow-up) of a choice architecture intervention to increase the healthiness of foods purchased by high school students from online canteens. However, there is little evidence regarding the long-term effectiveness of choice architecture interventions targeting adolescent food purchases, particularly those delivered online. Objective: This study aimed to determine the long-term effectiveness of a multi-strategy choice architecture intervention embedded within online canteen infrastructure in high schools at a 15-month follow-up. Methods: A cluster randomized controlled trial was undertaken with 1331 students (from 9 high schools) in New South Wales, Australia. Schools were randomized to receive the automated choice architecture intervention (including menu labeling, positioning, feedback, and prompting strategies) or the control (standard online ordering). The foods purchased were classified according to the New South Wales Healthy Canteen strategy as either “everyday,” “occasional,” or “should not be sold.” Primary outcomes were the average proportion of “everyday,” “occasional,” and “should not be sold” items purchased per student. Secondary outcomes were the mean energy, saturated fat, sugar, and sodium content of purchases. Outcomes were assessed using routine data collected by the online canteen. Results: From baseline to 15-month follow-up, on average, students in the intervention group ordered significantly more “everyday” items (+11.5%, 95% CI 7.3% to 15.6%; P<.001), and significantly fewer “occasional” (–5.4%, 95% CI –9.4% to –1.5%; P=.007) and “should not be sold” items (–6%, 95% CI –9.1% to –2.9%; P<.001), relative to controls. There were no between-group differences over time in the mean energy, saturated fat, sugar, or sodium content of lunch orders. Conclusions: Given their longer-term effectiveness, choice architecture interventions delivered via online canteens may represent a promising option for policy makers to support healthy eating among high school students. Trial Registration: Australian Clinical Trials ACTRN12620001338954, https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380546 ; Open Science Framework osf.io/h8zfr, https://osf.io/h8zfr/ %M 38502177 %R 10.2196/51108 %U https://www.jmir.org/2024/1/e51108 %U https://doi.org/10.2196/51108 %U http://www.ncbi.nlm.nih.gov/pubmed/38502177 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56562 %T A Social Media–Delivered Melanoma Prevention Program for Young Women Engaged in Frequent UV Tanning: Protocol for a Randomized Controlled Trial %A Stapleton,Jerod L %A Manne,Sharon L %A Pagoto,Sherry L %A Leip,Allison %A Greene,Kathryn %A Hillhouse,Joel J %A Merritt,Allison S %A Shelton,Brent J %+ Markey Cancer Center, College of Public Health, University of Kentucky, 342 Bowman Hall, Lexington, KY, 40508, United States, 1 8593237224, jerod.stapleton@uky.edu %K acceptance and commitment therapy %K body image %K dissonance-based intervention %K eHealth %K Facebook %K indoor tanning bed %K melanoma %K randomized controlled trial %K skin cancer %K social media %K sunbathing %D 2024 %7 19.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Rates of melanoma have increased dramatically in the United States over the past 25 years, and it has become among the most prevalent cancers for young adult women. Intentional skin tanning leads to a pattern of intense and intermittent UV radiation exposure that is associated with increased risk of melanoma. Frequent tanning is most common among young women and is linked to a variety of sociocultural pressures that negatively impact body image and drive appearance control behaviors. Unfortunately, there are no established interventions designed for frequent tanners. This intervention addresses this gap with unique content informed by body image and acceptance-based interventions. The intervention is delivered using Facebook secret groups, an approach designed to support behavior change and ensure scalability. Objective: This study aims to describe the rationale and methodology of a randomized controlled trial of a melanoma prevention program targeting young women engaged in frequent indoor or outdoor UV tanning. Methods: Participants are women aged 18-25 years who report high-risk tanning (ie, at least 10 indoor tanning sessions in the past 12 months or 10 outdoor sessions in the previous summer). After recruitment and screening, participants completed a baseline survey and were randomly assigned to receive the intervention or an attention-matched control condition. Both conditions were 8-week-long Facebook groups (approximately 25 members each) with daily posting of content. Follow-up surveys are administered at 3, 8, and 18 months after baseline. The primary trial outcome is the combined number of indoor and outdoor tanning sessions reported at the 8-month follow-up. Hypothesized intervention mediators are assessed at the 3-month follow-up. Results: This project was funded by a National Cancer Institute award (R01 CA218068), and the trial procedures were approved by the University of Kentucky Institutional Review Board in February 2020. Trial recruitment and enrollment occurred in 6 waves of data collection, which started in February 2022 and closed in May 2023. The study is closed to enrollment but remains open for follow-ups, and this protocol report was prepared before data analyses. As of February 2024, all participants have completed the 8-month follow-up assessment, and data collection is scheduled to close by the end of 2024 after the collection of the 18-month follow-up. Conclusions: This trial will contribute unique knowledge to the field of skin cancer prevention, as no fully powered trials have examined the efficacy of an intervention designed for frequent indoor or outdoor tanning. The trial may also contribute evidence of the value in translating principles of body image and acceptance-based interventions into the field of skin cancer prevention and beyond. If successful, the use of the Facebook platform is intended to aid in dissemination as it provides a way to embed the intervention into individuals’ everyday routines. Trial Registration: ClinicalTrials.gov NCT03441321; https://clinicaltrials.gov/study/NCT03441321 International Registered Report Identifier (IRRID): DERR1-10.2196/56562 %M 38502173 %R 10.2196/56562 %U https://www.researchprotocols.org/2024/1/e56562 %U https://doi.org/10.2196/56562 %U http://www.ncbi.nlm.nih.gov/pubmed/38502173 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e55041 %T Developing a Text Messaging Intervention to Prevent Binge and Heavy Drinking in a Military Population: Mixed Methods Development Study %A Aycock,Chase A %A Mallawaarachchi,Indika %A Wang,Xin-Qun %A Cassidy,Daniel G %A Ellis,Jordan M %A Klesges,Robert C %A Talcott,G Wayne %A Wiseman,Kara %+ Department of Public Health Sciences, University of Virginia, P.O. Box 800717, Charlottesville, VA, 22908, United States, 1 4342348126, kara.wiseman@virginia.edu %K text messaging %K alcohol reduction %K binge drinking %K US %K United States %K US military %K alcohol misuse %K military %K functioning %K readiness %K health %K career %K careers %K text message %K text messages %K short message service %K SMS %K SMS intervention %K drinking %K Air Force %K Airmen %K mixed methods approach %K message %K messages %K development study %K qualitative coding %K drinking alcohol %K alcohol consumption %K survey %K descriptive statistics %D 2024 %7 19.3.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Alcohol misuse is the fourth leading cause of death in the United States and a significant problem in the US military. Brief alcohol interventions can reduce negative alcohol outcomes in civilian and military populations, but additional scalable interventions are needed to reduce binge and heavy drinking. SMS text messaging interventions could address this need, but to date, no programs exist for military populations. Objective: We aimed to develop an SMS text messaging intervention to address binge and heavy drinking among Airmen in Technical Training in the US Air Force. Methods: We implemented a 2-phase, mixed methods study to develop the SMS text messaging intervention. In phase 1, a total of 149 respondents provided feedback about the persuasiveness of 49 expert-developed messages, preferences regarding message frequency, timing and days to receive messages, and suggested messages, which were qualitatively coded. In phase 2, a total of 283 respondents provided feedback about the persuasiveness of 77 new messages, including those developed through the refinement of messages from phase 1, which were coded and assessed based on the Behavior Change Technique Taxonomy (BCTT). For both phases, mean persuasiveness scores (range 1-5) were calculated and compared according to age (aged <21 or ≥21 years) and gender. Top-ranking messages from phase 2 were considered for inclusion in the final message library. Results: In phase 1, top-rated message themes were about warnings about adverse outcomes (eg, impaired judgment and financial costs), recommendations to reduce drinking, and invoking values and goals. Through qualitative coding of suggested messages, we identified themes related to warnings about adverse outcomes, recommendations, prioritizing long-term goals, team and belonging, and invoking values and goals. Respondents preferred to receive 1 to 3 messages per week (124/137, 90.5%) and to be sent messages on Friday, Saturday, and Sunday (65/142, 45.8%). In phase 2, mean scores for messages in the final message library ranged from 3.31 (SD 1.29) to 4.21 (SD 0.90). Of the top 5 highest-rated messages, 4 were categorized into 2 behavior change techniques (BCTs): valued self-identity and information about health consequences. The final message library includes 28 BCTT-informed messages across 13 BCTs, with messages having similar scores across genders. More than one-fourth (8/28, 29%) of the final messages were informed by the suggested messages from phase 1. As Airmen aged <21 years face harsher disciplinary action for alcohol consumption, the program is tailored based on the US legal drinking age. Conclusions: This study involved members from the target population throughout 2 formative stages of intervention development to design a BCTT-informed SMS text messaging intervention to reduce binge and heavy drinking, which is now being tested in an efficacy trial. The results will determine the impact of the intervention on binge drinking and alcohol consumption in the US Air Force. %M 38502165 %R 10.2196/55041 %U https://formative.jmir.org/2024/1/e55041 %U https://doi.org/10.2196/55041 %U http://www.ncbi.nlm.nih.gov/pubmed/38502165 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55210 %T Providing Lesbian, Gay, Bisexual, Transgender, Nonbinary, and Queer Adolescents With Nurturance, Trustworthiness, and Safety: Protocol for Pilot Cluster Randomized Controlled Trial Design %A Coulter,Robert WS %A Mahal,Isabella Kaur %A Lin,Clarisse A %A Schneider,Shari Kessel %A Mathias,Aaryn S %A Baral,Karuna %A Miller,Elizabeth %A Abebe,Kaleab Z %+ Department of Behavioral and Community Health Sciences, School of Public Health, University of Pittsburgh, 130 De Soto Street, Pittsburgh, PA, 15261, United States, 1 412 624 3001, robert.ws.coulter@pitt.edu %K sexual minority youths %K gender minority youths %K cluster randomized controlled trial %K web-based behavior change intervention %K high school staff %D 2024 %7 19.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Sexual and gender minority youths (lesbian, gay, bisexual, transgender, nonbinary, and queer individuals) face elevated risks of substance use (eg, alcohol and tobacco) and mental health issues (eg, depressive symptoms and suicidality) compared to their cisgender heterosexual peers. These inequities are hypothesized to be reduced by building supportive high school environments via the training of school staff. An intervention that trains school staff to better understand and support sexual and gender minority youths and engage in positive bystander behaviors that protect them from bullying exposure may reduce disparities in drug and alcohol use among them. Experts, school staff, and sexual and gender minority youths developed Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, and Safety (PLANTS), a web-based intervention to train school staff on how to support, affirm, and protect sexual and gender minority youths. Objective: This paper describes the design of the PLANTS pilot trial primarily aimed at assessing its acceptability, usability, appropriateness, and feasibility. We hypothesize PLANTS will have high acceptability, usability, appropriateness, and feasibility as rated by the school staff. Secondary objectives focus on implementation, safety, and pre-post changes in high school staff outcomes, including self-efficacy and skills (eg, active-empathic listening and bullying intervention). Exploratory objectives focus on the impact of PLANTS on student health outcomes. Methods: In a 2-arm cluster randomized controlled trial, high schools in Massachusetts are allocated to PLANTS or an active comparator group (publicly available sexual and gender minority youths resources or training). High school staff complete pretest and posttest surveys containing validated scales. Primary outcomes are validated measures of acceptability, usability, appropriateness, and feasibility of the intervention completed by staff during posttest surveys. To test our primary hypotheses for each outcome, we will calculate means and 95% CIs and P values using 1-sample 2-sided t tests against a priori thresholds or benchmarks of success. Secondary outcomes include staff’s active-empathetic listening skills, self-efficacy for working with sexual and gender minority youths, bystander intervention behaviors for bullying and cyberbullying, and self-efficacy for PLANTS’ change objectives completed during pretest and posttest staff surveys. Staff can also complete a posttest interview guided by the Information-Motivation-Behavior model and Consolidated Framework for Implementation Research. Exploratory outcomes include student-level data collected via the 2021 and 2023 MetroWest Adolescent Health Surveys, a health behavior surveillance system in 30 Massachusetts schools. Results: School enrollment began in May 2023 and participant enrollment began in June 2023. Data collection is expected to be completed by February 2024. Conclusions: This pilot trial will yield important information about the PLANTS intervention and provide necessary information to conduct a fully powered trial of the efficacy of PLANTS for reducing the deleterious health inequities experienced by sexual and gender minority youths. Trial Registration: ClinicalTrials.gov NCT05897827; https://clinicaltrials.gov/study/NCT05897827 International Registered Report Identifier (IRRID): DERR1-10.2196/55210 %M 38502156 %R 10.2196/55210 %U https://www.researchprotocols.org/2024/1/e55210 %U https://doi.org/10.2196/55210 %U http://www.ncbi.nlm.nih.gov/pubmed/38502156 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55193 %T Examining Parent Mood, Feeding Context, and Feeding Goals as Predictors of Feeding Practices Used by Parents of Preschool Children With Avid Eating Behavior: Protocol for an Ecological Momentary Assessment Study %A Edwards,Katie %A Croker,Helen %A Farrow,Claire %A Haycraft,Emma %A Herle,Moritz %A Llewellyn,Clare %A Pickard,Abigail %A Blissett,Jacqueline %+ School of Psychology and Institute of Health and Neurodevelopment, Aston University, Aston Triangle, Birmingham, B4 7ET, United Kingdom, 44 121 204 3784, k.edwards4@aston.ac.uk %K ecological momentary assessment %K avid eating %K children’s eating behavior %K parental feeding practices %K feeding behaviour %K parent %K children %K eating behaviour %K obesity %K environmental factors %K observational study %K feeding %K United Kingdom %D 2024 %7 19.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: An avid eating behavior profile is characterized by a greater interest in food and a tendency to overeat in response to negative emotions. Parents use specific strategies to manage feeding interactions with children with avid eating behavior. While momentary and contextual factors, such as parental mood, have been found to influence parental feeding practices, there is a lack of research examining parents’ daily experiences of feeding children with avid eating behavior. Examining this is important because parental feeding practices are key levers in tailored interventions to support children’s healthy eating behavior. Objective: We aim to describe the ecological momentary assessment methods and procedures used in the APPETItE (Appetite in Preschoolers: Producing Evidence for Tailoring Interventions Effectively) project, which aims to examine how variation in parental mood, feeding goals, and the context of eating occasions affect the parental feeding practices used to manage feeding interactions with children with an avid eating behavior profile. Methods: Participants are primary caregivers from the APPETItE cohort who have a preschool-age child (aged 3-5 years) with an avid eating behavior profile. Caregivers complete a 10-day ecological momentary assessment period using signal- and event-contingent surveys to examine (1) mood and stress, (2) parental feeding goals, and (3) contextual factors as predictors of parental feeding practices. Results: Recruitment and data collection began in October 2023 and is expected to be completed by spring 2024. The data have a 3-level structure: repeated measurements (level 1) nested within days (level 2) nested within an individual (level 3). Thus, lag-dependent models will be conducted to test the main hypotheses. Conclusions: The findings from this study will provide an understanding of caregivers’ daily experiences of feeding preschool children with avid eating behavior, who are at greater risk for the development of obesity. Understanding the predictors of feeding practices at the moment they occur, and across various contexts, will inform the development of tailored resources to support caregivers in managing children’s avid eating behavior. International Registered Report Identifier (IRRID): DERR1-10.2196/55193 %M 38502178 %R 10.2196/55193 %U https://www.researchprotocols.org/2024/1/e55193 %U https://doi.org/10.2196/55193 %U http://www.ncbi.nlm.nih.gov/pubmed/38502178 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e50200 %T Promoting Return to Work After Vocational Rehabilitation Using a Work-Related Fitness App: Protocol for a Cluster-Randomized Controlled Trial %A Bühne,David %A Elling,Jan Mathis %A Hetzel,Christian %A Alles,Torsten %+ Institute for Quality Assurance in Prevention and Rehabilitation (IQPR), German Sport University Cologne, Eupener Str 70, Köln, 50933, Germany, 49 221 27759920, buehne@iqpr.de %K digital health %K eHealth %K physical activity %K profile comparison %K vocational rehabilitation %D 2024 %7 18.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Retraining programs in vocational rehabilitation are often characterized by a low level of physical activity, even when targeting jobs with primarily physical demands. They might therefore be accompanied by a decline in functional capacity if the lack of physical activity is not compensated by increased activity during leisure time. The implementation of a work-related exercise app might be a promising approach to promoting a return to work in vocational rehabilitation. We developed the “WORKout-app” which provides exercise plans based on a comparison of the physical demands of the retraining profession and the current functional capacity. Objective: The aim of this study is to examine the effects of app-based exercise during vocational rehabilitation on perceived work ability (primary outcome), occupational self-efficacy, days of sick leave, and return to work (secondary outcomes). Methods: We conducted a cluster-randomized controlled trial with 2 arms (intervention: WORKout-app vs control: treatment as usual) in 4 cohorts of 5 vocational rehabilitation centers in Germany. Participants are nested within retraining classes per vocational rehabilitation center and per cohort assigned to either the intervention condition or the control condition. The target sample size at the participant level is 598. Measurement time points include baseline, the end of rehabilitation, 3 months after the end of rehabilitation, and 6 months after the end of rehabilitation. Linear and generalized linear mixed-effects models are performed to test for treatment differences in outcomes. Results: This study is funded by the German Federal Pension Insurance. The trial is registered with the German Clinical Trials Register (DRKS00030775) and approved by the Ethics Committee of the German Sport University Cologne (145/2022). Conclusions: The findings of the study will inform researchers and practitioners about the effectiveness of an exercise app developed to counteract the effects of physical inactivity during vocational rehabilitation. International Registered Report Identifier (IRRID): DERR1-10.2196/50200 %M 38498051 %R 10.2196/50200 %U https://www.researchprotocols.org/2024/1/e50200 %U https://doi.org/10.2196/50200 %U http://www.ncbi.nlm.nih.gov/pubmed/38498051 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e48504 %T The EMPOWER Occupational e–Mental Health Intervention Implementation Checklist to Foster e–Mental Health Interventions in the Workplace: Development Study %A Raggi,Alberto %A Bernard,Renaldo M %A Toppo,Claudia %A Sabariego,Carla %A Salvador Carulla,Luis %A Lukersmith,Sue %A Hakkaart-van Roijen,Leona %A Merecz-Kot,Dorota %A Olaya,Beatriz %A Antunes Lima,Rodrigo %A Gutiérrez-Marín,Desirée %A Vorstenbosch,Ellen %A Curatoli,Chiara %A Cacciatore,Martina %+ Neurology, Public Health and Disability Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Celoria 11, Milano, 20133, Italy, 39 0223943105, alberto.raggi@istituto-besta.it %K implementation %K workplace %K mental health %K well-being %K digital health %K mobile health %K mHealth %K eHealth %K e–mental health %K stakeholder consultation %K intervention %K occupational %K stakeholders %K consultation %K barrier %K checklist %D 2024 %7 15.3.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Occupational e–mental health (OeMH) interventions significantly reduce the burden of mental health conditions. The successful implementation of OeMH interventions is influenced by many implementation strategies, barriers, and facilitators across contexts, which, however, are not systematically tracked. One of the reasons is that international consensus on documenting and reporting the implementation of OeMH interventions is lacking. There is a need for practical guidance on the key factors influencing the implementation of interventions that organizations should consider. Stakeholder consultations secure a valuable source of information about these key strategies, barriers, and facilitators that are relevant to successful implementation of OeMH interventions. Objective: The objective of this study was to develop a brief checklist to guide the implementation of OeMH interventions. Methods: Based on the results of a recently published systematic review, we drafted a comprehensive checklist with a wide set of strategies, barriers, and facilitators that were identified as relevant for the implementation of OeMH interventions. We then used a 2-stage stakeholder consultation process to refine the draft checklist to a brief and practical checklist comprising key implementation factors. In the first stage, stakeholders evaluated the relevance and feasibility of items on the draft checklist using a web-based survey. The list of items comprised 12 facilitators presented as statements addressing “elements that positively affect implementation” and 17 barriers presented as statements addressing “concerns toward implementation.” If a strategy was deemed relevant, respondents were asked to rate it using a 4-point Likert scale ranging from “very difficult to implement” to “very easy to implement.” In the second stage, stakeholders were interviewed to elaborate on the most relevant barriers and facilitators shortlisted from the first stage. The interview mostly focused on the relevance and priority of strategies and factors affecting OeMH intervention implementation. In the interview, the stakeholders’ responses to the open survey’s questions were further explored. The final checklist included strategies ranked as relevant and feasible and the most relevant facilitators and barriers, which were endorsed during either the survey or the interviews. Results: In total, 26 stakeholders completed the web-based survey (response rate=24.8%) and 4 stakeholders participated in individual interviews. The OeMH intervention implementation checklist comprised 28 items, including 9 (32.1%) strategies, 8 (28.6%) barriers, and 11 (39.3%) facilitators. There was widespread agreement between findings from the survey and interviews, the most outstanding exception being the idea of proposing OeMH interventions as benefits for employees. Conclusions: Through our 2-stage stakeholder consultation, we developed a brief checklist that provides organizations with a guide for the implementation of OeMH interventions. Future research should empirically validate the effectiveness and usefulness of the checklist. %M 38488846 %R 10.2196/48504 %U https://www.jmir.org/2024/1/e48504 %U https://doi.org/10.2196/48504 %U http://www.ncbi.nlm.nih.gov/pubmed/38488846 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e45860 %T Lessons and Untapped Potential of Smartphone-Based Physical Activity Interventions for Mental Health: Narrative Review %A Bernstein,Emily E %A Wolfe,Emma C %A Huguenel,Brynn M %A Wilhelm,Sabine %+ Department of Psychology, University of Virginia, Gilmer Hall, 485 McCormick Road, Charlottesville, VA, 22903, United States, 1 3014665679, rpu3zk@virginia.edu %K smartphone %K digital health %K exercise %K physical activity %K mental health %K depression %K anxiety %K mobile phone %D 2024 %7 15.3.2024 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Physical activity has well-known and broad health benefits, including antidepressive and anxiolytic effects. However, only approximately half of Americans meet even the minimum exercise recommendations. Individuals with anxiety, depression, or related conditions are even less likely to do so. With the advent of mobile sensors and phones, experts have quickly noted the utility of technology for the enhanced measurement of and intervention for physical activity. In addition to being more accessible than in-person approaches, technology-driven interventions may uniquely engage key mechanisms of behavior change such as self-awareness. Objective: This study aims to provide a narrative overview and specific recommendations for future research on smartphone-based physical activity interventions for psychological disorders or concerns. Methods: In this paper, we summarized early efforts to adapt and test smartphone-based or smartphone-supported physical activity interventions for mental health. The included articles described or reported smartphone-delivered or smartphone-supported interventions intended to increase physical activity or reduce sedentary behavior and included an emotional disorder, concern, or symptom as an outcome measure. We attempted to extract details regarding the intervention designs, trial designs, study populations, outcome measures, and inclusion of adaptations specifically for mental health. In taking a narrative lens, we drew attention to the type of work that has been done and used these exemplars to discuss key directions to build on. Results: To date, most studies have examined mental health outcomes as secondary or exploratory variables largely in the context of managing medical concerns (eg, cancer and diabetes). Few trials have recruited psychiatric populations or explicitly aimed to target psychiatric concerns. Consequently, although there are encouraging signals that smartphone-based physical activity interventions could be feasible, acceptable, and efficacious for individuals with mental illnesses, this remains an underexplored area. Conclusions: Promising avenues for tailoring validated smartphone-based interventions include adding psychoeducation (eg, the relationship between depression, physical activity, and inactivity), offering psychosocial treatment in parallel (eg, cognitive restructuring), and adding personalized coaching. To conclude, we offer specific recommendations for future research, treatment development, and implementation in this area, which remains open and promising for flexible, highly scalable support. %M 38488834 %R 10.2196/45860 %U https://mhealth.jmir.org/2024/1/e45860 %U https://doi.org/10.2196/45860 %U http://www.ncbi.nlm.nih.gov/pubmed/38488834 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e49808 %T A Mobile Health App to Support Home-Based Aerobic Exercise in Neuromuscular Diseases: Usability Study %A Veneman,Tim %A Koopman,Fieke Sophia %A Oorschot,Sander %A Koomen,Pien G %A Nollet,Frans %A Voorn,Eric L %+ Amsterdam University Medical Center location University of Amsterdam, Rehabilitation Medicine, Meibergdreef 9, Amsterdam, 1105 AZ, Netherlands, 31 20 56 64421, e.l.voorn@amsterdamumc.nl %K neuromuscular disorders %K endurance training %K home-based exercise %K eHealth %K tele-rehabilitation %K app %K exercise %K aerobic exercise %K mhealth %K mobile app %K neuromuscular disease %K usability %D 2024 %7 15.3.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Home-based aerobic exercise in people with neuromuscular diseases (NMDs) has benefits compared to exercise in the hospital or a rehabilitation center because traveling is often cumbersome due to mobility limitations, and societal costs are lower. Barriers to home-based aerobic exercise include reduced possibilities for monitoring and lack of motivation. To overcome these and other barriers, we developed a mobile health app: Keep on training with ReVi (hereafter referred to as ReVi). Objective: We aimed to determine the usability of the ReVi app. Methods: Patients followed a 4-month, polarized, home-based aerobic exercise program on a cycle or rowing ergometer, with 2 low-intensity sessions and 1 high-intensity session per week supported by the ReVi app. The app collected training data, including heart rate and ratings of perceived exertion, provided real-time feedback on reaching target intensity zones, and enabled monitoring via an online dashboard. Physiotherapists instructed patients on how to use the ReVi app and supervised them during their training program. Patients and physiotherapists separately evaluated usability with self-developed questionnaires, including 9 questions on a 5-point Likert scale, covering the usability elements efficiency, effectiveness, and satisfaction. Results: Twenty-nine ambulatory adult patients (n=19 women; mean age 50.4, SD 14.2 years) with 11 different slowly progressive NMDs participated. Both patients and physiotherapists (n=10) reported that the app, in terms of its efficiency, was easy to use and had a rapid learning curve. Sixteen patients (55%) experienced 1 or more technical issue(s) during the course of the exercise program. In the context of effectiveness, 23 patients (81%) indicated that the app motivated them to complete the program and that it helped them to exercise within the target intensity zones. Most patients (n=19, 70%) and physiotherapists (n=6, 60%) were satisfied with the use of the app. The median attendance rate was 88% (IQR 63%-98%), with 76% (IQR 69%-82%) of time spent within the target intensity zones. Four adverse events were reported, 3 of which were resolved without discontinuation of the exercise program. Conclusions: The usability of the ReVi app was high, despite the technical issues that occurred. Further development of the app to resolve these issues is warranted before broader implementation into clinical practice. %M 38488838 %R 10.2196/49808 %U https://humanfactors.jmir.org/2024/1/e49808 %U https://doi.org/10.2196/49808 %U http://www.ncbi.nlm.nih.gov/pubmed/38488838 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e52809 %T A Closed-Loop Digital Health Tool to Improve Depression Care in Multiple Sclerosis: Iterative Design and Cross-Sectional Pilot Randomized Controlled Trial and its Impact on Depression Care %A Henderson,Kyra %A Reihm,Jennifer %A Koshal,Kanishka %A Wijangco,Jaeleene %A Sara,Narender %A Miller,Nicolette %A Doyle,Marianne %A Mallory,Alicia %A Sheridan,Judith %A Guo,Chu-Yueh %A Oommen,Lauren %A Rankin,Katherine P %A Sanders,Stephan %A Feinstein,Anthony %A Mangurian,Christina %A Bove,Riley %+ Department of Neurology, Weill Institute for Neurosciences, University of California, San Francisco, 1651 4th Street, San Francisco, CA, 94158, United States, 1 4155027209, riley.bove@ucsf.edu %K depression %K quality of life %K bring your own device %K mHealth %K closed-loop %K clinical trial %K multiple sclerosis %D 2024 %7 15.3.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: People living with multiple sclerosis (MS) face a higher likelihood of being diagnosed with a depressive disorder than the general population. Although many low-cost screening tools and evidence-based interventions exist, depression in people living with MS is underreported, underascertained by clinicians, and undertreated. Objective: This study aims to design a closed-loop tool to improve depression care for these patients. It would support regular depression screening, tie into the point of care, and support shared decision-making and comprehensive follow-up. After an initial development phase, this study involved a proof-of-concept pilot randomized controlled trial (RCT) validation phase and a detailed human-centered design (HCD) phase. Methods: During the initial development phase, the technological infrastructure of a clinician-facing point-of-care clinical dashboard for MS management (BRIDGE) was leveraged to incorporate features that would support depression screening and comprehensive care (Care Technology to Ascertain, Treat, and Engage the Community to Heal Depression in people living with MS [MS CATCH]). This linked a patient survey, in-basket messages, and a clinician dashboard. During the pilot RCT phase, a convenience sample of 50 adults with MS was recruited from a single MS center with 9-item Patient Health Questionnaire scores of 5-19 (mild to moderately severe depression). During the routine MS visit, their clinicians were either asked or not to use MS CATCH to review their scores and care outcomes were collected. During the HCD phase, the MS CATCH components were iteratively modified based on feedback from stakeholders: people living with MS, MS clinicians, and interprofessional experts. Results: MS CATCH links 3 features designed to support mood reporting and ascertainment, comprehensive evidence-based management, and clinician and patient self-management behaviors likely to lead to sustained depression relief. In the pilot RCT (n=50 visits), visits in which the clinician was randomized to use MS CATCH had more notes documenting a discussion of depressive symptoms than those in which MS CATCH was not used (75% vs 34.6%; χ21=8.2; P=.004). During the HCD phase, 45 people living with MS, clinicians, and other experts participated in the design and refinement. The final testing round included 20 people living with MS and 10 clinicians including 5 not affiliated with our health system. Most scoring targets for likeability and usability, including perceived ease of use and perceived effectiveness, were met. Net Promoter Scale was 50 for patients and 40 for clinicians. Conclusions: Created with extensive stakeholder feedback, MS CATCH is a closed-loop system aimed to increase communication about depression between people living with MS and their clinicians, and ultimately improve depression care. The pilot findings showed evidence of enhanced communication. Stakeholders also advised on trial design features of a full year long Department of Defense–funded feasibility and efficacy trial, which is now underway. Trial Registration: ClinicalTrials.gov NCT05865405; http://tinyurl.com/4zkvru9x %M 38488827 %R 10.2196/52809 %U https://formative.jmir.org/2024/1/e52809 %U https://doi.org/10.2196/52809 %U http://www.ncbi.nlm.nih.gov/pubmed/38488827 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e53742 %T Patient-Centered Approaches for Designing Destigmatizing Sexual Pain-Related Web-Based Platforms: Qualitative Study %A Abdulai,Abdul-Fatawu %A Naghdali,Hasti %A Noga,Heather %A Yong,Paul J %+ School of Nursing, University of British Columbia, T201-2211 Wesbrook Mall, Vancouver, BC, V6T 2B5, Canada, 1 604 822 7214, fatawu.abdulai@ubc.ca %K stigma %K digital health %K sexual pain %K destigmatizing %K end user patients %D 2024 %7 15.3.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Sexual pain is a common but neglected disorder that affects approximately 3% to 18% of women and an unmeasured number of gender-diverse people worldwide. Despite its wide prevalence, many people feel reluctant to visit conventional health care services or disclose their symptoms due to the fear of stigmatization. To alleviate this stigma, various web-based interventions have been developed to complement and, in some cases, replace conventional sexual health interventions. However, the way these web-based interventions are developed could inadvertently reproduce, perpetuate, or exacerbate stigma among end user patients. Objective: The purpose of this study was to understand patients’ perspectives on how sexual pain–related web platforms can be designed to alleviate stigma or prevent the unintended effects of stigma among patients who use web-based interventions. Methods: Individual semistructured interviews were conducted among 16 participants with lived experiences of painful sex in a large urban city in Western Canada. Participants were recruited via social media platforms, newsletters, and a provincial health volunteer website. Using a sample sexual pain website to provide context, participants were interviewed about their experiences of stigma and how they think web platforms could be designed to address stigma. The interviews were conducted via Zoom (Zoom Technologies Inc) and analyzed using thematic analysis. Results: The findings revealed 4 overarching themes that represented participants’ perspectives on designing web platforms that may alleviate or prevent the unintended effects of stigma. These findings suggested the design of inclusive web platforms, having a nonprovocative and calming user interface, having features that facilitate connections among users and between users and providers, and displaying personal testimonials and experiences of sexual pain. Conclusions: This study highlighted patient-centered design approaches that could serve as a reference guide in developing web platforms that alleviate or prevent the unintended effects of stigma, particularly among nonheterosexual and gender-diverse people. While this study was conducted in the context of sexual pain, the results might also apply to web platforms on other potentially stigmatizing health-related disorders or conditions. %M 38488844 %R 10.2196/53742 %U https://formative.jmir.org/2024/1/e53742 %U https://doi.org/10.2196/53742 %U http://www.ncbi.nlm.nih.gov/pubmed/38488844 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e50056 %T Adapting the Number of Questions Based on Detected Psychological Distress for Cognitive Behavioral Therapy With an Embodied Conversational Agent: Comparative Study %A Shidara,Kazuhiro %A Tanaka,Hiroki %A Adachi,Hiroyoshi %A Kanayama,Daisuke %A Kudo,Takashi %A Nakamura,Satoshi %+ Nara Institute of Science and Technology, 8916-5, Takayama-cho, Ikoma, 630-0192, Japan, 81 80 4687 8116, shidara.kazuhiro.sc5@is.naist.jp %K cognitive behavioral therapy %K psychological distress detection %K embodied conversational agents %K automatic thoughts %K long short-term memory %K multitask learning %D 2024 %7 14.3.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: The high prevalence of mental illness is a critical social problem. The limited availability of mental health services is a major factor that exacerbates this problem. One solution is to deliver cognitive behavioral therapy (CBT) using an embodied conversational agent (ECA). ECAs make it possible to provide health care without location or time constraints. One of the techniques used in CBT is Socratic questioning, which guides users to correct negative thoughts. The effectiveness of this approach depends on a therapist’s skill to adapt to the user’s mood or distress level. However, current ECAs do not possess this skill. Therefore, it is essential to implement this adaptation ability to the ECAs. Objective: This study aims to develop and evaluate a method that automatically adapts the number of Socratic questions based on the level of detected psychological distress during a CBT session with an ECA. We hypothesize that this adaptive approach to selecting the number of questions will lower psychological distress, reduce negative emotional states, and produce more substantial cognitive changes compared with a random number of questions. Methods: In this study, which envisions health care support in daily life, we recruited participants aged from 18 to 65 years for an experiment that involved 2 different conditions: an ECA that adapts a number of questions based on psychological distress detection or an ECA that only asked a random number of questions. The participants were assigned to 1 of the 2 conditions, experienced a single CBT session with an ECA, and completed questionnaires before and after the session. Results: The participants completed the experiment. There were slight differences in sex, age, and preexperimental psychological distress levels between the 2 conditions. The adapted number of questions condition showed significantly lower psychological distress than the random number of questions condition after the session. We also found a significant difference in the cognitive change when the number of questions was adapted based on the detected distress level, compared with when the number of questions was fewer than what was appropriate for the level of distress detected. Conclusions: The results show that an ECA adapting the number of Socratic questions based on detected distress levels increases the effectiveness of CBT. Participants who received an adaptive number of questions experienced greater reductions in distress than those who received a random number of questions. In addition, the participants showed a greater amount of cognitive change when the number of questions matched the detected distress level. This suggests that adapting the question quantity based on distress level detection can improve the results of CBT delivered by an ECA. These results illustrate the advantages of ECAs, paving the way for mental health care that is more tailored and effective. %M 38483464 %R 10.2196/50056 %U https://formative.jmir.org/2024/1/e50056 %U https://doi.org/10.2196/50056 %U http://www.ncbi.nlm.nih.gov/pubmed/38483464 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e43875 %T Novel Web-Based Drop-In Mindfulness Sessions (Pause-4-Providers) to Enhance Well-Being Among Health Care Workers During the COVID-19 Pandemic: Descriptive and Qualitative Study %A Elliott,Mary %A Khallouf,Camille %A Hirsch,Jennifer %A de Camps Meschino,Diane %A Zamir,Orit %A Ravitz,Paula %+ Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 610 University Ave, Toronto, ON, M5G 2C1, Canada, 1 416 946 2000, mary.elliott@uhn.ca %K COVID-19 %K pandemic %K health care worker %K resilience %K mental health %K burnout %K well-being %K mindfulness meditation %K web-based group %K drop-in %K mindfulness %K health care staff %K meditation %K worker %K job %K occupational health %D 2024 %7 14.3.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: The COVID-19 pandemic exerted extraordinary pressure on health care workers (HCWs), imperiling their well-being and mental health. In response to the urgent demand to provide barrier-free support for the health care workforce, Pause-4-Providers implemented 30-minute live web-based drop-in mindfulness sessions for HCWs. Objective: This study aims to evaluate the use, feasibility, satisfaction, and acceptability of a novel mindfulness program aimed at enhancing the well-being of HCWs during the COVID-19 pandemic. Methods: Accrual for the study continued throughout the first 3 pandemic waves, and attendees of ≥1 session were invited to participate. The evaluation framework included descriptive characteristics, including participant demographics, resilience at work, and single-item burnout scores; feedback questionnaires on reasons attended, benefits, and satisfaction; qualitative interviews to further understand participant experience, satisfaction, benefits, enablers, and barriers; and the number of participants in each session summarized according to the pandemic wave. Results: We collected descriptive statistics from 50 consenting HCWs. Approximately half of the participants (24/50, 48%) attended >1 session. The study participants were predominantly female individuals (40/50, 80%) and comprised physicians (17/50, 34%), nurses (9/50, 18%), and other HCWs (24/50, 48%), who were largely from Ontario (41/50, 82%). Of 50 attendees, 26 (52%) endorsed feeling burned out. The highest attendance was in May 2020 and January 2021, corresponding to the first and second pandemic waves. The participants endorsed high levels of satisfaction (43/47, 92%). The most cited reasons for attending the program were to relax (38/48, 79%), manage stress or anxiety (36/48, 75%), wish for loving kindness or self-compassion (30/48, 64%), learn mindfulness (30/48, 64%), and seek help with emotional reactivity (25/48, 53%). Qualitative interviews with 15 out of 50 (30%) participants identified positive personal and professional impacts. Personal impacts revealed that participation helped HCWs to relax, manage stress, care for themselves, sleep better, reduce isolation, and feel recognized. Professional impacts included having a toolbox of mindfulness techniques, using mindfulness moments, and being calmer at work. Some participants noted that they shared techniques with their colleagues. The reported barriers included participants’ needing time to prioritize themselves, fatigue, forgetting to apply skills on the job, and finding a private place to participate. Conclusions: The Pause-4-Providers participants reported that the web-based groups were accessible; appreciated the format, content, and faculty; and had high levels of satisfaction with the program. Both novel format (eg, drop-in, live, web-based, anonymous, brief, and shared activity with other HCWs) and content (eg, themed mindfulness practices including micropractices, with workplace applications) were enablers to participation. This study of HCW support sessions was limited by the low number of consenting participants and the rolling enrollment project design; however, the findings suggest that a drop-in web-based mindfulness program has the potential to support the well-being of HCWs. %M 38180869 %R 10.2196/43875 %U https://formative.jmir.org/2024/1/e43875 %U https://doi.org/10.2196/43875 %U http://www.ncbi.nlm.nih.gov/pubmed/38180869 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56683 %T Integration of an Electronic Screening, Brief Intervention, and Referral to Treatment Program Into an HIV Testing Program to Reduce Substance Use and HIV Risk Behavior Among Men Who Have Sex With Men: Protocol for Intervention Development and a Pilot Randomized Controlled Trial %A Balán,Iván C %A Marone,Ruben O %A Barreda,Victoria %A Naar,Sylvie %A Wang,Yuxia %+ Center for Translational Behavioral Science, Department of Behavioral Science and Social Medicine, Florida State University College of Medicine, 2010 Levy Ave., Bldg. B, Suite 0266, Tallahassee, FL, 32310, United States, 1 2017250565, ibalan@fsu.edu %K HIV %K substance use %K community health %K implementation science %K eHealth %D 2024 %7 14.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Men who have sex with men (MSM) are disproportionally affected by HIV and drug and alcohol use; however, few effective HIV prevention interventions for MSM who use substances exist. Screening, Brief Intervention, and Referral to Treatment is an early intervention for non–treatment-seeking individuals with problematic substance use and for timely referral to treatment for those with substance use disorders. Electronic screening and brief interventions (e-SBIs) reduce implementation challenges. An e-SBI tailored for MSM at the time of HIV testing might be particularly opportune to strengthen their motivation to reduce substance use and HIV risk behavior. Objective: This study aims to develop a tailored e-SBI program to reduce substance use and HIV risk behavior among MSM seeking HIV testing at Nexo Asociación Civil, our community partners in Argentina (primary); assess the feasibility and acceptability of integrating the e-SBI into the Nexo HIV testing program (primary); assess the feasibility and acceptability of implementing an adapted Men’s Health Project (MHP) at Nexo (secondary); and finally, explore preliminary findings on substance use and sexual risk reduction outcomes (exploratory). Methods: This mixed methods study has 2 stages. During stage 1 (development), we will use the User Centered Rapid App Design process consisting of focus groups (n=16), individual interviews (n=24), and a pilot deployment of the e-SBI (n=50) to iteratively develop the e-SBI. Quantitative and qualitative assessments at each step will inform the revision of the e-SBI. Furthermore, we will use the assessment, decision, administration, production, topic experts, integration, training, testing framework to adapt MHP. During stage 2 (pilot randomized controlled trial [RCT]), we will randomize 200 MSM coming to Nexo for HIV testing. They will complete a baseline assessment and then their assigned intervention (e-SBI vs screening only) and will be followed-up for 6 months. We will also conduct in-depth interviews with up to 45 participants: 15 participants from either study condition who entered or completed MHP or other substance abuse treatment and 15 from each arm who met the criteria for MHP but did not request it. Results: The study began recruitment in October 2022, and the stage-1 pilot study is near completion. Preliminary findings from stage 1 show high e-SBI acceptability. Data analysis of the stage-1 pilot is now beginning. The stage-2 pilot RCT will be launched in March 2024, with all data collection completed by May 2025. Conclusions: This study will allow us to assess the acceptability and feasibility of e-SBI implementation during HIV testing encounters. We will also build the necessary research infrastructure for a subsequent RCT to assess the efficacy of e-SBIs in reducing substance use and HIV sexual risk behavior among MSM in this setting. Trial Registration: ClinicalTrials.gov NCT05542914; https://tinyurl.com/yyjj64dm. International Registered Report Identifier (IRRID): DERR1-10.2196/56683 %M 38483463 %R 10.2196/56683 %U https://www.researchprotocols.org/2024/1/e56683 %U https://doi.org/10.2196/56683 %U http://www.ncbi.nlm.nih.gov/pubmed/38483463 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56016 %T Testing Biological and Psychological Pathways of Emotion Regulation as a Primary Mechanism of Action in Yoga Interventions for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial %A Starkweather,Angela R %A Xu,Wanli %A Gnall,Katherine E %A Emrich,Mariel %A Garnsey,Camille L %A Magin,Zachary E %A Wu,Weizi %A Fetta,Joseph %A Groessl,Erik J %A Park,Crystal %+ Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, 1225 Center Drive, Gainesville, FL, 32610, United States, 1 352 263 6321, a.starkweather@ufl.edu %K chronic low back pain %K clinical trial %K emotion regulation %K mind-body interventions %K pain sensitivity %K yoga %D 2024 %7 14.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Interventions that promote adaptive emotion regulation (ER) skills reduce pain in patients with chronic pain; however, whether the effects of yoga practice on chronic low back pain (CLBP) are due to improvements in ER remains to be examined. Objective: This study will test whether the effects of yoga on CLBP (improved pain severity and interference) are mediated by improved ER, the extent to which effects are related to specific aspects of ER, and the role of pain sensitization as a mediator or moderator of effects. In this study, pain sensitization will be assessed by quantitative sensory testing and gene expression profiles to examine whether pain sensitization moderates yoga’s effects on pain or whether yoga and ER abilities reduce pain sensitization, leading to decreased pain severity and interference. Methods: For this 2-arm parallel group blinded randomized controlled trial, we will enroll 204 adults with CLBP who will be randomized to receive the yoga (n=102) or a control stretching and strengthening (n=102) intervention, which are delivered via web-based synchronous biweekly 75-minute sessions over 12 weeks. Participants are encouraged to practice postures or exercises for 25 minutes on other days using accessible prerecorded practice videos that are sent to participants digitally. Participants will be assessed at 5 time points: baseline, midintervention (6 weeks), postintervention (12 weeks), and 3- and 6-month follow-ups. Assessments of ER, pain severity and interference, pain sensitivity including somatosensory and gene expression profiles, and physical strength and flexibility will be conducted at each visit. The fidelity of the interventions is assessed using a manualized checklist to evaluate recorded group sessions to ensure consistent instructor delivery. Results: The primary outcome will be the mean change in pain severity as measured by the Brief Pain Inventory-Short Form at 12 weeks. The primary mechanism of action is ER measured by change in the Difficulties in Emotion Regulation Scale total score. Secondary outcomes include pain sensitivity, physical strength and flexibility, pain interference, and quality of life. A mediation path analysis and series of moderated mediation path analyses will be conducted to test the study hypotheses. As of January 2024, we have enrolled 138 participants. We expect the study to be completed by May 2025. Conclusions: The study will provide important data for evaluating whether improvements in ER are responsible for reduced pain perception and pain sensitivity as well as increased quality of life in the context of chronic pain. The study findings have important implications for determining the mechanism of action for yoga and possibly other mind-body interventions as nonpharmacological therapies for pain management. The results of the study will inform the content, delivery, and measures for intervention trials involving yoga as a modality for relieving pain and improving function. Trial Registration: ClinicalTrials.gov NCT04678297; https://clinicaltrials.gov/study/NCT04678297 International Registered Report Identifier (IRRID): DERR1-10.2196/56016 %M 38483469 %R 10.2196/56016 %U https://www.researchprotocols.org/2024/1/e56016 %U https://doi.org/10.2196/56016 %U http://www.ncbi.nlm.nih.gov/pubmed/38483469 %0 Journal Article %@ 2291-9694 %I JMIR Publications %V 12 %N %P e46699 %T The Key Digital Tool Features of Complex Telehealth Interventions Used for Type 2 Diabetes Self-Management and Monitoring With Health Professional Involvement: Scoping Review %A Mannoubi,Choumous %A Kairy,Dahlia %A Menezes,Karla Vanessa %A Desroches,Sophie %A Layani,Geraldine %A Vachon,Brigitte %+ School of Rehabilitation, Université de Montréal, 7077, avenue du Parc, Montreal, QC, H3N 1X7, Canada, 1 5143436111, cmannoubi@gmail.com %K telehealth %K telemedicine %K telenutrition %K telemonitoring %K electronic coaching %K e-coaching %K scoping review %K type 2 diabetes %K prediabetes %K diabetes management %K diabetes self-management %K mobile phone %D 2024 %7 13.3.2024 %9 Review %J JMIR Med Inform %G English %X Background: Therapeutic education and patient self-management are crucial in diabetes prevention and treatment. Improving diabetes self-management requires multidisciplinary team intervention, nutrition education that facilitates self-management, informed decision-making, and the organization and delivery of appropriate health care services. The emergence of telehealth services has provided the public with various tools for educating themselves and for evaluating, monitoring, and improving their health and nutrition-related behaviors. Combining health technologies with clinical expertise, social support, and health professional involvement could help persons living with diabetes improve their disease self-management skills and prevent its long-term consequences. Objective: This scoping review’s primary objective was to identify the key digital tool features of complex telehealth interventions used for type 2 diabetes or prediabetes self-management and monitoring with health professional involvement that help improve health outcomes. A secondary objective was to identify how these key features are developed and combined. Methods: A 5-step scoping review methodology was used to map relevant literature published between January 1, 2010 and March 31, 2022. Electronic searches were performed in the MEDLINE, CINAHL, and Embase databases. The searches were limited to scientific publications in English and French that either described the conceptual development of a complex telehealth intervention that combined self-management and monitoring with health professional involvement or evaluated its effects on the therapeutic management of patients with type 2 diabetes or prediabetes. Three reviewers independently identified the articles and extracted the data. Results: The results of 42 studies on complex telehealth interventions combining diabetes self-management and monitoring with the involvement of at least 1 health professional were synthesized. The health professionals participating in these studies were physicians, dietitians, nurses, and psychologists. The digital tools involved were smartphone apps or web-based interfaces that could be used with medical devices. We classified the features of these technologies into eight categories, depending on the intervention objective: (1) monitoring of glycemia levels, (2) physical activity monitoring, (3) medication monitoring, (4) diet monitoring, (5) therapeutic education, (6) health professional support, (7) other health data monitoring, and (8) health care management. The patient-logged data revealed behavior patterns that should be modified to improve health outcomes. These technologies, used with health professional involvement, patient self-management, and therapeutic education, translate into better control of glycemia levels and the adoption of healthier lifestyles. Likewise, they seem to improve monitoring by health professionals and foster multidisciplinary collaboration through data sharing and the development of more concise automatically generated reports. Conclusions: This scoping review synthesizes multiple studies that describe the development and evaluation of complex telehealth interventions used in combination with health professional support. It suggests that combining different digital tools that incorporate diabetes self-management and monitoring features with a health professional’s advice and interaction results in more effective interventions and outcomes. %M 38477979 %R 10.2196/46699 %U https://medinform.jmir.org/2024/1/e46699 %U https://doi.org/10.2196/46699 %U http://www.ncbi.nlm.nih.gov/pubmed/38477979 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e52790 %T Effectiveness of One Videoconference-Based Exposure and Response Prevention Session at Home in Adjunction to Inpatient Treatment in Persons With Obsessive-Compulsive Disorder: Nonrandomized Study %A Voderholzer,Ulrich %A Meule,Adrian %A Koch,Stefan %A Pfeuffer,Simone %A Netter,Anna-Lena %A Lehr,Dirk %A Zisler,Eva Maria %+ Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Nußbaumstraße 7, Munich, 80336, Germany, 49 15205886528, Eva.Zisler@med.uni-muenchen.de %K obsessive-compulsive disorder %K videoconference-based treatment %K therapy %K exposure %K response prevention %K OCD %K prevention %K inpatient %K video %K videoconference %K therapist %K therapists %K mood %K positive mood %K environment %K clinical setting %D 2024 %7 13.3.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Therapist-guided exposure and response prevention (ERP) for the treatment of obsessive-compulsive disorder (OCD) is frequently conducted within clinical settings but rarely at places where patients are usually confronted with OCD symptom-provoking situations in daily life (eg, at home). Objective: This study aimed to investigate patients’ views on 1 ERP session at home via videoconference and its impact on treatment outcome. Methods: A total of 64 inpatients with OCD received 1 session of therapist-guided videoconference-based ERP at home in adjunction to a multimodal inpatient treatment between 2015 and 2020. Results: Compared with 64 age- and sex-matched controls who received a multimodal inpatient treatment without 1 session of videoconference-based ERP at home, patients who received 1 session of videoconference-based ERP in adjunction to a multimodal inpatient treatment showed stronger reductions in OCD symptom severity from admission to discharge. Before the videoconference-based ERP session, patients reported high rationale credibility and treatment expectancy. After the videoconference-based ERP session, patients reported medium-to-high positive mood as well as depth and smoothness of the session, and they perceived the working alliance as high. Conclusions: Results highlight the importance of administering therapist-guided ERP sessions in patients’ natural environment to enhance treatment response in OCD. Videoconference-based ERP as add-on to treatment as usual is, therefore, a promising approach to facilitate the application of ERP in patients’ natural environment and foster the generalization of ERP conducted in clinical settings. %M 38477970 %R 10.2196/52790 %U https://mental.jmir.org/2024/1/e52790 %U https://doi.org/10.2196/52790 %U http://www.ncbi.nlm.nih.gov/pubmed/38477970 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e54163 %T Mobile App/Web Platform for Monitoring Food Oral Immunotherapy in Children: Longitudinal Clinical Validation Study %A Sánchez-Fernández,Sergio %A Lasa,Eva María %A Terrados,Soledad %A Sola-Martínez,Francisco Javier %A Martínez-Molina,Sara %A López de Calle,Marta %A Cabrera-Freitag,Paula %A Goikoetxea,María José %+ Allergy and Clinical Immunology Department, Clínica Universidad de Navarra, Pío XII, 36, Pamplona, 31008, Spain, 34 948255400, mjgoiko@unav.es %K adverse reactions %K egg allergy %K food oral immunotherapy %K mHealth %K milk allergy %K monitoring %D 2024 %7 13.3.2024 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Milk and egg allergies significantly impact the quality of life, particularly in children. In this regard, food oral immunotherapy (OIT) has emerged as an effective treatment option; however, the occurrence of frequent adverse reactions poses a challenge, necessitating close monitoring during treatment. Objective: This study aims to evaluate the ability of a new mobile/web app called OITcontrol to monitor milk and egg OIT. Methods: Patients undergoing milk or egg OIT were recruited and divided into 2 groups: the active group used the OITcontrol app in conjunction with standard written monitoring methods, whereas the control group relied solely on written diaries. Investigators documented hospital doses, hospital reactions, and administered treatments on the website. Patients recorded their daily allergen home-dose intake, home reactions, and administered treatments using the app. The following variables were compared between both groups: number and severity of hospital and reported home reactions, patient’s adhesion to the OITcontrol app or written diary or both in terms of daily home-dose intake and home reactions recording, and treatment and dose adjustment compliance at home in case of reaction. Results: Sixteen patients were assigned to be monitored using the OITcontrol app along with additional written methods (active group), while 14 patients relied solely on a written paper diary (control group). A similar distribution was observed in terms of sex, age, basal characteristics, allergen treated in OIT, premedication, and sensitization profile. Active patients reported a comparable number of hospital and home reactions compared with the control group. In terms of recording system usage, 13/16 (81%) active patients used the OITcontrol app, while 10/14 (71%) control patients relied on the written diary. Among active patients, 6/16 (38%) used both methods, and 1 active patient used only written methods. However, control patients recorded home reactions more frequently than active patients (P=.009). Among active patients, the app was the preferred method for recording reactions (59/86, 69%), compared with the written diary (15/86, 17%) or both methods (12/86, 14%; P<.001). Treatment compliance in home-recorded reactions was similar between both groups (P=.15). However, treatment indications after an adverse reaction were more frequently followed (P=.04) in reactions recorded solely in the app (36/59, 61%) than in the written diary (29/71, 41%) or both systems (4/12, 33%). Moreover, compliance with dose adjustments after a moderate-severe reaction in home-recorded reactions was higher in the active group than in the control group (P<.001). Home reactions recorded only in the app (16/19, 84%) were more likely to follow dose adjustments (P<.001) than those recorded in the written diary (3/20, 15%) or using both methods (2/3, 67%). Conclusions: The OITcontrol app appears to be a valuable tool for monitoring OIT treatment in children with food allergies. It proves to be a suitable method for recording daily home dose intakes and reactions, and it seems to enhance adherence to treatment indications following an adverse reaction as well as compliance with dose adjustments in home reactions. However, additional studies are necessary to comprehensively grasp the benefits and limitations of using the OITcontrol app in the management of OIT. %M 38477961 %R 10.2196/54163 %U https://pediatrics.jmir.org/2024/1/e54163 %U https://doi.org/10.2196/54163 %U http://www.ncbi.nlm.nih.gov/pubmed/38477961 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 9 %N %P e53835 %T Outcomes of an Asynchronous Care Model for Chronic Conditions in a Diverse Population: 12-Month Retrospective Chart Review Study %A Hofner,Michael %A Hurnaus,Patrick %A DiStefano,Dan %A Philip,Shaji %A Kim,Sarah %A Shaw,Julie %A Waring,Avantika Chander %+ 9amHealth, 914 N Coast Highway 101, Suite A, Encinitas, CA, 92024, United States, 1 (202) 932 9958, avantika.waring@9am.health %K asynchronous %K blood pressure %K cardiology %K chronic disease %K cohort %K diabetes mellitus therapy %K diabetes %K diabetics %K eHealth %K e-health %K HbA1c %K health disparities %K heart %K hemoglobin A1c %K hypertension therapy %K hypertension %K hypertensive %K remote care %K retrospective %K telehealth %K telemedicine %K virtual care %D 2024 %7 13.3.2024 %9 Original Paper %J JMIR Diabetes %G English %X Background: Diabetes and hypertension are some of the most prevalent and costly chronic conditions in the United States. However, outcomes continue to lag behind targets, creating further risk of long-term complications, morbidity, and mortality for people living with these conditions. Furthermore, racial and ethnic disparities in glycemic and hypertension control persist. Flexible telehealth programs leveraging asynchronous care allow for increased provider access and more convenient follow-up, ultimately improving critical health outcomes across demographic groups. Objective: We aim to evaluate the 12-month clinical outcomes of participants in the 9amHealth web-based clinic for diabetes and hypertension. We hypothesized that participation in the 9amHealth program would be associated with significant improvements in glycemic and blood pressure (BP) control across a diverse group of individuals. Methods: We enrolled 95 patients in a completely web-based care clinic for diabetes and hypertension who received nutrition counseling, health coaching, and asynchronous physician consultations for medication prescribing. Patients received standard or cellular-connected glucose meters and BP cuffs in order to share data. Laboratory tests were completed either with at-home phlebotomy draws or a self-administered test kit. Patients’ first and last hemoglobin A1c (HbA1c) and BP results over the 12-month period were compared, and analyses were repeated across race and ethnicity groups. Results: Among all 95 patients, the average HbA1c decreased by –1.0 (from 8.2% to 7.2%; P<.001) over 12 months of program participation. In those with a baseline HbA1c >8%, the average HbA1c decreased by –2.1 (from 10.2% to 8.1%; P<.001), and in those with a baseline HbA1c >9%, the average HbA1c decreased by –2.8 (from 11% to 8.2%; P<.001). Among participants who identified as a race or ethnicity other than White, the HbA1c decreased by –1.2 (from 8.6% to 7.4%, P=.001). Further examination of subgroups confirmed HbA1c lowering within each race or ethnicity group. In the overall population, the average systolic BP decreased by 17.7 mm Hg (P=.006) and the average diastolic BP decreased by 14.3 mm Hg (P=.002). Among participants self-identifying as a race or ethnicity other than White, the results similarly showed a decrease in BP (average reduction in systolic BP of 10 mm Hg and in diastolic BP of 9 mm Hg). Conclusions: A fully web-based model leveraging all-asynchronous physician review and prescribing, combined with synchronous and asynchronous coaching and nutrition support, was associated with clinically meaningful improvement in HbA1c and BP control over a 12-month period among a diverse group of individuals. Further studies should prospectively evaluate the effectiveness of such models among larger populations, assess the longer-term sustainability of these outcomes, and explore financial models to make these types of programs broadly accessible. %M 38363585 %R 10.2196/53835 %U https://diabetes.jmir.org/2024/1/e53835 %U https://doi.org/10.2196/53835 %U http://www.ncbi.nlm.nih.gov/pubmed/38363585 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e50737 %T Implementing a Sodium-Glucose Cotransporter 2 Inhibitor Module With a Software Tool (Future Health Today): Qualitative Study %A Suen,Matthew %A Manski-Nankervis,Jo-Anne %A McBride,Caroline %A Lumsden,Natalie %A Hunter,Barbara %+ Department of General Practice and Primary Care, University of Melbourne, Level 3, North Wing, Building, 181 Grattan Street, Medical Building, Parkville, 3010, Australia, 61 383443369, matthew.suen@unimelb.edu.au %K type 2 diabetes %K CP-FIT %K electronic health %K clinical decision support tool %K primary care %K SGLT2 inhibitor %K complication %K tool %K digital health intervention %K thematic analysis %K decision support %K diabetes management %D 2024 %7 13.3.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Primary care plays a key role in the management of type 2 diabetes. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have been demonstrated to reduce hospitalization and cardiac and renal complications. Tools that optimize management, including appropriate prescribing, are a priority for treating chronic diseases. Future Health Today (FHT) is software that facilitates clinical decision support and quality improvement. FHT applies algorithms to data stored in electronic medical records in general practice to identify patients who are at risk of a chronic disease or who have a chronic disease that may benefit from intensification of management. The platform continues to evolve because of rigorous evaluation, continuous improvement, and expansion of the conditions hosted on the platform. FHT currently displays recommendations for the identification and management of chronic kidney disease, cardiovascular disease, type 2 diabetes, and cancer risk. A new module will be introduced to FHT focusing on SGLT2 inhibitors in patients with type 2 diabetes who have chronic kidney diseases, cardiovascular diseases, or risk factors for cardiovascular disease. Objective: The study aims to explore the barriers and enablers to the implementation of an SGLT2 inhibitor module within the Future Health Today software. Methods: Clinic staff were recruited to participate in interviews on their experience in their use of a tool to improve prescribing behavior for SGLT2 inhibitors. Thematic analysis was guided by Clinical Performance Feedback Intervention Theory. Results: In total, 16 interviews were completed. Identified enablers of use included workflow alignment, clinical appropriateness, and active delivery of the module. Key barriers to use were competing priorities, staff engagement, and knowledge of the clinical topic. Conclusions: There is a recognized benefit to the use of a clinical decision support tool to support type 2 diabetes management, but barriers were identified that impeded the usability and actionability of the module. Successful and effective implementation of this tool could support the optimization of patient management of type 2 diabetes in primary care. %M 38477973 %R 10.2196/50737 %U https://formative.jmir.org/2024/1/e50737 %U https://doi.org/10.2196/50737 %U http://www.ncbi.nlm.nih.gov/pubmed/38477973 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54251 %T Navigating Social Cognitive Impairments in Schizophrenia Spectrum Disorders: Protocol for a Pilot Pre-Post Quasi-Experimental Study for Remote Avatar-Assisted Cognitive Remediation Therapy %A Thibaudeau,Elisabeth %A Peyroux,Elodie %A Franck,Nicolas %A Carling,Hannah %A Lepage,Martin %+ Douglas Research Center, 6875 Boulevard LaSalle, Montreal, QC, H4H 1R3, Canada, 1 514 761 6131 ext 4393, elisabeth.thibaudeau@mail.mcgill.ca %K social cognition %K schizophrenia spectrum disorder %K psychosis %K cognitive remediation therapy %K social cognitive training %K digital relational simulation %K cultural adaptation %K feasibility %K acceptability %K mobile phone %D 2024 %7 13.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Social cognitive impairments are prevalent in schizophrenia spectrum disorder (SSD) and have detrimental effects on functioning. Cognitive remediation (CR) has shown its efficacy in improving social cognitive impairments, although the transfer of these skills to daily life and the personalization of these interventions remain challenging. RC2S (Remédiation Cognitive de la Cognition Sociale dans la Schizophrénie; Cognitive remediation of social cognition in Schizophrenia) is a French CR that combines the learning of strategies and practice using paper-and-pencil exercises and digital relational simulations. This French program was designed as an in-person intervention. Objective: This project aims to culturally adapt the RC2S program, in French-Canadian and North American English and to assess the feasibility, acceptability, safety, and implementation of a remote version in people with SSD. An exploratory objective is to assess the preliminary effect of remote RC2S on goal attainment, social cognition, and psychosocial outcomes. Methods: We will use a pre-post quasi-experimental design. First, the translation and cultural adaptation in North American English and French-Canadian of RC2S is presented. Then, 20 participants aged ≥18 years with a diagnosis of SSD, presenting with a subjective or an objective impairment in social cognition, will be included to receive RC2S. In addition, 5 therapists will be included as research participants to assess their perspective on RC2S. Participants with SSD will undergo a baseline remote assessment of their social cognition, clinical symptoms, and functioning. They will then start remote RC2S for 24 biweekly individual 1-hour sessions with a therapist. Following the case formulation and goal setting, participants will complete personalized paper-and-pencil exercises to develop strategies and integrative digital relational simulations, during which they will help an avatar navigate through a variety of social contexts and relationships. The last 2 sessions are dedicated to the transfer to daily life. All participants will complete in-session questionnaires assessing therapeutic alliance, motivation, acceptability, feasibility, and implementation. Following RC2S, the participants with SSD will repeat the same assessment as the baseline. Descriptive statistics will be used to summarize the data about acceptability, feasibility, safety, and implementation. To assess the preliminary effect of RC2S, an intention-to-treat approach will be used with linear mixed models for repeated measures with fixed effects of time. Results: So far, 45% (9/20) of participants with SSD (mean age 37.9, SD 9.3 years) have completed the project. They received a mean of 20.5 out of 24 (SD 3.5) sessions of RC2S. A total of 5 therapists also completed the project. Conclusions: Improving social cognitive impairments is an important target in SSD to promote functional recovery. Using digital technologies to address these impairments and deliver the intervention is a promising approach to increase the ecological validity of CR and access to the intervention. Trial Registration: ClinicalTrials.gov NCT05017532; https://classic.clinicaltrials.gov/ct2/show/NCT05017532 International Registered Report Identifier (IRRID): DERR1-10.2196/54251 %M 38477975 %R 10.2196/54251 %U https://www.researchprotocols.org/2024/1/e54251 %U https://doi.org/10.2196/54251 %U http://www.ncbi.nlm.nih.gov/pubmed/38477975 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e50741 %T Effects of a Social Media Intervention on Vaping Intentions: Randomized Dose-Response Experiment %A Evans,William Douglas %A Bingenheimer,Jeffrey %A Cantrell,Jennifer %A Kreslake,Jennifer %A Tulsiani,Shreya %A Ichimiya,Megumi %A D'Esterre,Alexander P %A Gerard,Raquel %A Martin,Madeline %A Hair,Elizabeth C %+ Milken Institute School of Public Health, The George Washington University, 950 New Hampshire Ave NW, Washington, DC, 20052, United States, 1 2023519546, wdevans@gwu.edu %K randomized controlled trial %K e-cigarettes %K vaping %K nicotine %K tobacco control %K social media %K dose-response effects %D 2024 %7 12.3.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: e-Cigarette use, especially by young adults, is at unacceptably high levels and represents a public health risk factor. Digital media are increasingly being used to deliver antivaping campaigns, but little is known about their effectiveness or the dose-response effects of content delivery. Objective: The objectives of this study were to evaluate (1) the effectiveness of a 60-day antivaping social media intervention in changing vaping use intentions and beliefs related to the stimulus content and (2) the dose-response effects of varying levels of exposure to the intervention on vaping outcomes, including anti-industry beliefs, vaping intentions, and other attitudes and beliefs related to vaping. Methods: Participants were adults aged 18 to 24 years in the United States. They were recruited into the study through Facebook (Meta Platforms) and Instagram (Meta Platforms), completed a baseline survey, and then randomized to 1 of the 5 conditions: 0 (control), 4, 8, 16, and 32 exposures over a 15-day period between each survey wave. Follow-up data were collected 30 and 60 days after randomization. We conducted stratified analyses of the full sample and in subsamples defined by the baseline vaping status (never, former, and current). Stimulus was delivered through Facebook and Instagram in four 15-second social media videos focused on anti-industry beliefs about vaping. The main outcome measures reported in this study were self-reported exposure to social media intervention content, attitudes and beliefs about vaping, and vaping intentions. We estimated a series of multivariate linear regressions in Stata 17 (StataCorp). To capture the dose-response effect, we assigned each study arm a numerical value corresponding to the number of advertisements (exposures) delivered to participants in each arm and used this number as our focal independent variable. In each model, the predictor was the treatment arm to which each participant was assigned. Results: The baseline sample consisted of 1491 participants, and the final analysis sample consisted of 57.28% (854/1491) of the participants retained at the 60-day follow-up. We compared the retained participants with those lost to follow-up and found no statistically significant differences across demographic variables. We found a significant effect of the social media treatment on vaping intentions (β=−0.138, 95% CI −0.266 to −0.010; P=.04) and anti-industry beliefs (β=−0.122, 95% CI 0.008-0.237; P=.04) targeted by the intervention content among current vapers but not among the full sample or other strata. We found no significant effects of self-reported exposure to the stimulus. Conclusions: Social media interventions are a promising approach to preventing vaping among young adults. More research is needed on how to optimize the dosage of such interventions and the extent to which long-term exposure may affect vaping use over time. Trial Registration: ClinicalTrials.gov NCT04867668; https://clinicaltrials.gov/study/NCT04867668 %M 38470468 %R 10.2196/50741 %U https://www.jmir.org/2024/1/e50741 %U https://doi.org/10.2196/50741 %U http://www.ncbi.nlm.nih.gov/pubmed/38470468 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55435 %T Effectiveness of the Pasifika Women’s Diabetes Wellness Program (PWDWP): Protocol for a Pilot Intervention and Feasibility Randomized Controlled Trial %A Akbar,Heena %A Contor,Madison %A Niumata,Winnie %A Anderson,Debra %A Gallegos,Danielle %+ School of Public Health, Faculty of Medicine, The University of Queensland, 288 Herston Rd, Herston, Brisbane, 4006, Australia, 61 423460211, h.akbar@uq.edu.au %K type 2 diabetes %K Māori and Pasifika women %K diabetes self-management %K culturally co-design intervention %K Pasifika diaspora %K talanoa %D 2024 %7 11.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Type 2 diabetes poses public health challenges for Māori and Pasifika communities in Australia. The women of these communities face a greater burden from type 2 diabetes–related mortality and comorbidities. Lifestyle modification behaviors through previous women’s wellness programs have been shown to reduce the risk of developing complications in established type 2 diabetes. The Pasifika Women’s Diabetes Wellness Program (PWDWP) pilot study, co-designed with Māori and Pasifika communities, was aimed at addressing late hospital presentations from diabetes-related complications. Objective: This study (1) examines the efficacy of women with type 2 diabetes in the intervention group for improved glycated hemoglobin (HbA1c) clinical levels and diabetes self-management compared with the control group from baseline (T0) to week 12 (T1) and week 24 (T2; postintervention) and (2) assesses the cultural adaptability, acceptability, and feasibility of the pilot intervention for future studies. Methods: This study uses a quasiexperimental design that involves a 24-week intervention. We recruited 50 Māori and Pasifika women with type 2 diabetes (25 in the intervention group from the south side of Brisbane and 25 in the control group from the north side of Brisbane) using participatory talanoa methodologies. The intervention group participated in face-to-face and virtual whānau education workshops (5 weeks) and had access to individual coaching and virtual support delivered by trained Māori and Pasifika health professionals and community health workers. The control group received usual care with their identified health provider. Both groups received copies of the PWDWP journal, fact sheets, and a health check passbook with tailored motivational text messages. An advisory committee was set up to oversee the program implementation, including protocols of engagement, health checks, and data collection in community settings. The quantitative data were collected at T0, T1, and T2 with HbA1c as the primary outcome measure. Secondary outcomes measured changes in diabetes self-care and body composition (eg, BMI, waist circumference). Qualitative data will ascertain the program’s feasibility and cultural adaptability using talanoa focus groups. Results: This pilot study was approved by the Queensland University of Technology Human Ethic Research Committee (5609) and began in January 2023 after participant recruitment between July 2022 and December 2022. The final data collection including the health check, focus group, and survey data was completed in November 2023, and data analysis and reporting are expected to conclude in 2024. Conclusions:  This study provides a blueprint for PWDWP. Collaborative partnerships with community organizations and stakeholders are crucial for program success and suggest a potential model for targeting diabetes management for Māori and Pasifika communities, emphasizing the need for culturally relevant interventions. The findings will have significant implications for policymakers and practitioners when developing and implementing public health initiatives, particularly for communities with unique cultural nuances. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12622001100785p; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384470&isReview=true International Registered Report Identifier (IRRID): DERR1-10.2196/55435 %M 38286130 %R 10.2196/55435 %U https://www.researchprotocols.org/2024/1/e55435 %U https://doi.org/10.2196/55435 %U http://www.ncbi.nlm.nih.gov/pubmed/38286130 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e52324 %T Development of a Multiplatform Tool for the Prevention of Prevalent Mental Health Pathologies in Adults: Protocol for a Randomized Control Trial %A Ramos,Nadia %A Besoain,Felipe %A Cancino,Natalia %A Gallardo,Ismael %A Albornoz,Paula %A Fresno,Andres %A Spencer,Rosario %A Schott,Soledad %A Núñez,Daniel %A Salgado,Carolina %A Campos,Susana %+ Center of Applied Psychology, Faculty of Psychology, University of Talca, 1 Poniente 1141, Talca, 3460000, Chile, 56 71 2 201783, susana.campos@utalca.cl %K adults %K anxiety %K depression %K eHealth %K mental health %K mobile app %K RCT %D 2024 %7 11.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The prevalence of depression and anxiety has increased in recent years, with many individuals having trouble accessing mental health support. Smartphones have become an integral part of modern life, with apps offering new ways to deliver evidence-based self-help strategies to cope with common mental health symptoms. However, most of them do not have empirical evidence of their overall effectiveness or the effectiveness of their components, which could pose a risk for users. Objective: The aim of this study is to evaluate the effectiveness of the modules of evaluation, psychoeducation, and emotional regulation strategies in a multiplatform self-help mental health mobile app in the Maule region of Chile. Methods: A sample of 196 adults will be selected, who will be randomly assigned to different components of the app for a fixed period to assess its ability to reduce symptomatology. Results: The trial is not yet recruiting and is expected to end in October 2024. The first results are expected in April 2024. Conclusions: This is the first study in Chile to develop and test the effectiveness of a mobile app to manage anxiety and depression symptoms in adults. The intervention proposed is based on evidence suggesting that the internet or remote intervention tools and self-management of prevalent symptomatology could be the future of mental health care systems in the digital era. If the effects of the intervention are positive, wide implementation in Chile and other Spanish-speaking countries could be possible in the future. International Registered Report Identifier (IRRID): PRR1-10.2196/52324 %M 38466982 %R 10.2196/52324 %U https://www.researchprotocols.org/2024/1/e52324 %U https://doi.org/10.2196/52324 %U http://www.ncbi.nlm.nih.gov/pubmed/38466982 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e40406 %T Mobile-Delivered Mindfulness Intervention on Anxiety Level Among College Athletes: Randomized Controlled Trial %A Gao,Yu %A Shi,Lu %A Fu,Ning %A Yang,Nan %A Weeks-Gariepy,Tracy %A Mao,Yuping %+ Department of Health Science, Pace University, One Pace Plaza, New York, NY, 10038, United States, 1 (866) 722 3338, lshi@pace.edu %K anxiety %K athletes %K body %K calmness %K cognition %K college students %K college %K feasibility %K feedback %K intervention %K meditation %K mHealth %K mindfulness %K mobile %K participant %K positive %K program %K relaxation %K sleep %K students %D 2024 %7 8.3.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: College athletes are a group often affected by anxiety. Few interventional studies have been conducted to address the anxiety issues in this population. Objective: We conducted a mobile-delivered mindfulness intervention among college athletes to study its feasibility and efficacy in lowering their anxiety level and improving their mindfulness (measured by the Five Facet Mindfulness Questionnaire [FFMQ]). Methods: In April 2019, we recruited 290 college athletes from a public university in Shanghai, China, and 288 of them were randomized into an intervention group and a control group (closed trial), with the former (n=150) receiving a therapist-guided, smartphone-delivered mindfulness-based intervention and the latter receiving mental health promotion messages (n=138). We offered in-person instructions during the orientation session for the intervention group in a classroom, with the therapist interacting with the participants on the smartphone platform later during the intervention. We used generalized linear modeling and the intent-to-treat approach to compare the 2 groups' outcomes in dispositional anxiety, precompetition anxiety, and anxiety during competition, plus the 5 dimensions of mindfulness (measured by the FFMQ). Results: Our intent-to-treat analysis and generalized linear modeling found no significant difference in dispositional anxiety, precompetition anxiety, or anxiety during competition. Only the “observation” facet of mindfulness measures had a notable difference between the changes experienced by the 2 groups, whereby the intervention group had a net gain of .214 yet fell short of reaching statistical significance (P=.09). Participants who specialized in group sports had a higher level of anxiety (β=.19; SE=.08), a lower level of “nonjudgemental inner experience” in FFMQ (β=–.07; SE=.03), and a lower level of “nonreactivity” (β=–.138; SE=.052) than those specializing in individual sports. Conclusions: No significant reduction in anxiety was detected in this study. Based on the participant feedback, the time availability for mindfulness practice and session attendance for these student athletes in an elite college could have compromised the intervention’s effectiveness. Future interventions among this population could explore a more student-friendly time schedule (eg, avoid final exam time) or attempt to improve cognitive and scholastic outcomes. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900024449; https://www.chictr.org.cn/showproj.html?proj=40865 %M 38457201 %R 10.2196/40406 %U https://www.jmir.org/2024/1/e40406 %U https://doi.org/10.2196/40406 %U http://www.ncbi.nlm.nih.gov/pubmed/38457201 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54635 %T An mHealth Intervention to Address Depression and Improve Antiretroviral Therapy Adherence Among Youths Living With HIV in Uganda: Protocol for a Pilot Randomized Controlled Trial %A Nabunya,Proscovia %A Cavazos-Rehg,Patricia %A Mugisha,James %A Kasson,Erin %A Namuyaba,Olive Imelda %A Najjuuko,Claire %A Nsubuga,Edward %A Filiatreau,Lindsey M %A Mwebembezi,Abel %A Ssewamala,Fred M %+ International Center for Child Health and Development, Brown School, Washington University in St. Louis, One Brookings Drive, Campus Box 1196, St. Louis, MO, 63130, United States, 1 3149359087, nabunyap@wustl.edu %K depression %K adherence %K mHealth %K cognitive behavioral therapy %K antiretroviral therapy %K youth living with HIV %K Uganda %D 2024 %7 8.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: People living with HIV often struggle with mental health comorbidities that lower their antiretroviral therapy (ART) adherence. There is growing evidence that depression treatment may improve ART adherence and result in improved HIV outcomes. Given that mental health services are severely underequipped in low-resource settings, including in Uganda, new solutions to increase access to mental health care and close the treatment gap are urgently needed. This protocol paper presents the Suubi-Mhealth study, which proposed to develop a mobile health (mHealth) intervention for use among Ugandan youths (14-17 years) with comorbid HIV and depression, taking into account their unique contextual, cultural, and developmental needs. Objective: The proposed study is guided by the following objectives: (1) to develop and iteratively refine an intervention protocol for Suubi-Mhealth based on formative work to understand the needs of youths living with HIV; (2) to explore the feasibility and acceptability of Suubi-Mhealth on a small scale to inform subsequent refinement; (3) to test the preliminary impact of Suubi-Mhealth versus a waitlist control group on youths’ outcomes, including depression and treatment adherence; and (4) to examine barriers and facilitators for integrating Suubi-Mhealth into health care settings. Methods: Youths will be eligible to participate in the study if they are (1) 14-17 years of age, (2) HIV-positive and aware of their status, (3) receiving care and ART from one of the participating clinics, and (4) living within a family. The study will be conducted in 2 phases. In phase 1, we will conduct focus group discussions with youths and health care providers, for feedback on the proposed intervention content and methods, and explore the feasibility and acceptability of the intervention. In phase II, we will pilot-test the preliminary impact of the intervention on reducing depression and improving ART adherence. Assessments will be conducted at baseline, 1-, 2-, and 6-months post intervention completion. Results: Participant recruitment for phase 1 is completed. Youths and health care providers participated in focus group discussions to share their feedback on the proposed Suubi-Mhealth intervention content, methods, design, and format. Transcription and translation of focus group discussions have been completed. The team is currently developing Suubi-Mhealth content based on participants’ feedback. Conclusions: This study will lay important groundwork for several initiatives at the intersection of digital therapeutics, HIV treatment, and mental health, especially among sub-Saharan African youths, as they transition through adolescence and into adult HIV care settings. Trial Registration: ClinicalTrials.gov NCT05965245; https://clinicaltrials.gov/study/NCT05965245 International Registered Report Identifier (IRRID): DERR1-10.2196/54635 %M 38457202 %R 10.2196/54635 %U https://www.researchprotocols.org/2024/1/e54635 %U https://doi.org/10.2196/54635 %U http://www.ncbi.nlm.nih.gov/pubmed/38457202 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e52882 %T Decreasing Opioid Addiction and Diversion Using Behavioral Economics Applied Through a Digital Engagement Solution: Protocol for a Randomized Controlled Trial %A Rizvi,Rubina Fatima %A Schoephoerster,Jamee Ann %A Desphande,Sagar Satish %A Usher,Michael %A Oien,Andy Elaine %A Peters,Maya Marie %A Loth,Matthew Scott %A Bahr,Matthew William %A Ventz,Steffen %A Koopmeiners,Joseph Stephen %A Melton,Genevieve B %+ Division of Computational Health Sciences, Department of Surgery, University of Minnesota, 11-132 Phillips-Wangensteen Building, 516 Delaware Street Southeast, Minneapolis, MN, 55455, United States, 1 612 626 1999, gmelton@umn.edu %K opioid abuse %K opioid naïve patients %K opioid addiction %K behavioral economics %K nudges %K MyChart %K personal health record %K post-operative care %K opioid %K opioid use %K randomized controlled trial %K RCT %K behavioral economics %K digital engagement %K health crisis %K overdose %K acute pain %K pain %K tool %K tools %K phone app %K website %K application %D 2024 %7 8.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite strong and growing interest in ending the ongoing opioid health crisis, there has been limited success in reducing the prevalence of opioid addiction and the number of deaths associated with opioid overdoses. Further, 1 explanation for this is that existing interventions target those who are opiate-dependent but do not prevent opioid-naïve patients from becoming addicted. Objective: Leveraging behavioral economics at the patient level could help patients successfully use, discontinue, and dispose of their opioid medications in an acute pain setting. The primary goal of this project is to evaluate the effect of the 3 versions of the Opioid Management for You (OPY) tool on measures of opioid use relative to the standard of care by leveraging a pragmatic randomized controlled trial (RCT). Methods: A team of researchers from the Center for Learning Health System Sciences (CLHSS) at the University of Minnesota partnered with M Health Fairview to design, build, and test the 3 versions of the OPY tool: social influence, precommitment, and testimonial version. The tool is being built using the Epic Care Companion (Epic Inc) platform and interacts with the patient through their existing MyChart (Epic Systems Corporation) personal health record account, and Epic patient portal, accessed through a phone app or the MyChart website. We have demonstrated feasibility with pilot data of the social influence version of the OPY app by targeting our pilot to a specific cohort of patients undergoing upper-extremity procedures. This study will use a group sequential RCT design to test the impact of this important health system initiative. Patients who meet OPY inclusion criteria will be stratified into low, intermediate, and high risk of opiate use based on their type of surgery. Results: This study is being funded and supported by the CLHSS Rapid Prospective Evaluation and Digital Technology Innovation Programs, and M Health Fairview. Support and coordination provided by CLHSS include the structure of engagement, survey development, data collection, statistical analysis, and dissemination. The project was initially started in August 2022. The pilot was launched in February 2023 and is still running, with the data last counted in August 2023. The actual RCT is planned to start by early 2024. Conclusions: Through this RCT, we will test our hypothesis that patient opioid use and diverted prescription opioid availability can both be improved by information delivery applied through a behavioral economics lens via sending nudges directly to the opioid users through their personal health record. Trial Registration: ClinicalTrials.gov NCT06124079; https://clinicaltrials.gov/study/NCT06124079 International Registered Report Identifier (IRRID): PRR1-10.2196/52882 %M 38457203 %R 10.2196/52882 %U https://www.researchprotocols.org/2024/1/e52882 %U https://doi.org/10.2196/52882 %U http://www.ncbi.nlm.nih.gov/pubmed/38457203 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e52427 %T Developing a Novel Web-Based Self-Management Support Intervention for Polycystic Ovary Syndrome: Mixed Methods Study With Patients and Health Care Professionals %A Percy,Carol %A Turner,Andrew %A Orr,Charys %+ Centre for Intelligent Healthcare, Coventry University, Priory Street, Coventry, CV1 5FB, United Kingdom, 44 2477 659 337, c.percy@coventry.ac.uk %K anxiety %K depression %K PCOS %K peer support %K polycystic ovary syndrome %K positive well-being %K psychoeducation %K self-management %K web-based health intervention %K women’s health %D 2024 %7 7.3.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Polycystic ovary syndrome (PCOS) represents a significant global health burden requiring urgent attention. This common chronic endocrine and cardiometabolic condition affects around 1 in 10 women and individuals assigned female at birth, with significant adverse effects on well-being, quality of life, and mental health, as well as serious and complex long-term health consequences. International guidelines for best health care practice recommend the provision of comprehensive cognitive behavioral interventions to support self-management and improve health outcomes for those living with PCOS. Web-based health interventions have the potential to meet this need in an accessible and scalable way. Objective: We aim to identify barriers to self-management and psychological well-being in women with PCOS and adapt a web-based self-management program to provide a prototype digital support intervention for them. Methods: We adapted an existing support program (HOPE) for PCOS using the antecedent target measure approach. We conducted qualitative interviews with 13 adult women living with PCOS, 3 trustees of a patients with PCOS advocacy charity, and 4 endocrinologists to identify “antecedents” (barriers) to self-management and psychological well-being. Framework analysis was used to identify potentially modifiable antecedents to be targeted by the novel intervention. At a national conference, 58 key stakeholders (patients and health professionals) voted for the antecedents they felt were most important to address. We used research evidence and relevant theory to design a prototype for the PCOS intervention. Results: Voting identified 32 potentially modifiable antecedents, relating to knowledge, understanding, emotions, motivation, and behaviors, as priorities to be targeted in the new intervention. A modular, web-based prototype HOPE PCOS intervention was developed to address these, covering six broad topic areas (instilling HOPE for PCOS; managing the stress of PCOS; feeding your mind and body well; body image, intimacy, and close relationships; staying healthy with PCOS; and keeping PCOS in its place). Conclusions: We identified barriers to self-management and psychological well-being in women with PCOS and used these to adapt a web-based self-management program, tailoring it for PCOS, which is a comprehensive group intervention combining education, empowerment, lifestyle management, peer support with cognitive behavioral tools, and goal-setting (to be delivered by peers or codelivered with health care professionals). The modular structure offers flexibility to adapt the program further as new clinical recommendations emerge. The intervention has the potential to be delivered, evaluated for feasibility, and, if effective, integrated into health care services. Self-management interventions are not designed to replace clinical care; rather, they serve as an additional source of support. The HOPE PCOS program conveys this message in its content and activities. Future research should evaluate the prototype intervention using primary outcomes such as measures of psychological well-being, self-management self-efficacy, depression, anxiety, and PCOS-related quality of life. They should also assess the intervention’s acceptability, scalability, and cost-effectiveness. %M 38451567 %R 10.2196/52427 %U https://formative.jmir.org/2024/1/e52427 %U https://doi.org/10.2196/52427 %U http://www.ncbi.nlm.nih.gov/pubmed/38451567 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e48026 %T Status and Influencing Factors of Social Media Addiction in Chinese Workers: Cross-Sectional Survey Study %A Kong,Weitao %A Li,Yuanyuan %A Luo,Aijing %A Xie,Wenzhao %+ The Second Xiangya Hospital, Central South University, 139 Renmin Middle Road, Changsha, 410000, China, 86 0731 85292212, luoaj@csu.edu.cn %K social media addiction %K job burnout %K mindfulness %K mobile phone %K technology addiction %K cross-sectional survey %D 2024 %7 6.3.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Social media addiction (SMA) caused by excessive dependence on social media is becoming a global problem. At present, most of the SMA studies recruit college students as research participants, with very few studies involving workers and other age groups, especially in China. Objective: This study aims to investigate the current status of SMA among Chinese workers and analyze its influencing factors. Methods: From November 1, 2022, to January 30, 2023, we conducted an anonymous web-based questionnaire survey in mainland China, and a total of 5176 participants completed the questionnaire. The questionnaire included the Social Networking Service Addiction Scale, Maslach Burnout Inventory–General Survey scale, Mindful Attention Awareness Scale, as well as questionnaires regarding participants’ social media use habits and demographic information. Results: Through strict screening, 3468 valid questionnaires were included in this study. The main findings of this study revealed the following: the average SMA score of workers was higher (mean 53.19, SD 12.04), and some of them (393/3468, 11.33%) relied heavily on social media; there were statistically significant differences in SMA scores among workers in different industries (F14,3453=3.98; P<.001); single workers (t3106=8.6; P<.001) and workers in a relationship (t2749=5.67; P<.001) had higher SMA scores than married workers, but some married workers (214/3468, 6.17%) were highly dependent on social media; the level of SMA among female workers was higher than that of male workers (t3466=3.65; P<.001), and the SMA score of workers negatively correlated with age (r=−0.22; P<.001) and positively correlated with education level (r=0.12; P<.001); the frequency of using social media for entertainment during work (r=0.33; P<.001) and the frequency of staying up late using social media (r=0.14; P<.001) were positively correlated with the level of SMA in workers; and the level of SMA in workers was significantly positively correlated with their level of burnout (r=0.35; P<.001), whereas it was significantly negatively correlated with their level of mindfulness (r=−0.55; P<.001). Conclusions: The results of this study suggest that SMA among Chinese workers is relatively serious and that the SMA problem among workers requires more attention from society and academia. In particular, female workers, young workers, unmarried workers, highly educated workers, workers with bad social media habits, workers with high levels of job burnout, and workers with low levels of mindfulness were highly dependent on social media. In addition, occupation is an important influencing factor in SMA. Thus, the government should strengthen the supervision of social media companies. Medical institutions should provide health education on SMA and offer intervention programs for those addicted to social media. Workers should cultivate healthy habits while using social media. %M 38446542 %R 10.2196/48026 %U https://www.jmir.org/2024/1/e48026 %U https://doi.org/10.2196/48026 %U http://www.ncbi.nlm.nih.gov/pubmed/38446542 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 9 %N %P e48310 %T Acceptability of Mobile App–Based Motivational Interviewing and Preferences for App Features to Support Self-Management in Patients With Type 2 Diabetes: Qualitative Study %A Yoon,Sungwon %A Tang,Haoming %A Tan,Chao Min %A Phang,Jie Kie %A Kwan,Yu Heng %A Low,Lian Leng %+ Health Services and Systems Research, Duke-NUS Medical School, 8 College Rd, Singapore, 169857, Singapore, 65 66013198, sungwon.yoon@duke-nus.edu.sg %K mobile health %K motivational interviewing %K diabetes %K self-management %K health coaching %K acceptability %K application %K management %K type 2 diabetes %K communication %K patient barrier %K healthy behavior %K feedback %K visualization %K hybrid model %D 2024 %7 6.3.2024 %9 Original Paper %J JMIR Diabetes %G English %X Background: Patients with type 2 diabetes mellitus (T2DM) experience multiple barriers to improving self-management. Evidence suggests that motivational interviewing (MI), a patient-centered communication method, can address patient barriers and promote healthy behavior. Despite the value of MI, existing MI studies predominantly used face-to-face or phone-based interventions. With the growing adoption of smartphones, automated MI techniques powered by artificial intelligence on mobile devices may offer effective motivational support to patients with T2DM. Objective: This study aimed to explore the perspectives of patients with T2DM on the acceptability of app-based MI in routine health care and collect their feedback on specific MI module features to inform our future intervention. Methods: We conducted semistructured interviews with patients with T2DM, recruited from public primary care clinics. All interviews were audio recorded and transcribed verbatim. Thematic analysis was conducted using NVivo. Results: In total, 33 patients with T2DM participated in the study. Participants saw MI as a mental reminder to increase motivation and a complementary care model conducive to self-reflection and behavior change. Yet, there was a sense of reluctance, mainly stemming from potential compromise of autonomy in self-care by the introduction of MI. Some participants felt confident in their ability to manage conditions independently, while others reported already making changes and preferred self-management at their own pace. Compared with in-person MI, app-based MI was viewed as offering a more relaxed atmosphere for open sharing without being judged by health care providers. However, participants questioned the lack of human touch, which could potentially undermine a patient-provider therapeutic relationship. To sustain motivation, participants suggested more features of an ongoing supportive nature such as the visualization of milestones, gamified challenges and incremental rewards according to achievements, tailored multimedia resources based on goals, and conversational tools that are interactive and empathic. Conclusions: Our findings suggest the need for a hybrid model of intervention involving both app-based automated MI and human coaching. Patient feedback on specific app features will be incorporated into the module development and tested in a randomized controlled trial. %M 38446526 %R 10.2196/48310 %U https://diabetes.jmir.org/2024/1/e48310 %U https://doi.org/10.2196/48310 %U http://www.ncbi.nlm.nih.gov/pubmed/38446526 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e46195 %T Evaluation of the Effectiveness of Suicide.ca, Quebec’s Digital Suicide Prevention Strategy Platform: Cross-Sectional Descriptive Study %A Côté,Louis-Philippe %A Lane,Julie %+ Centre for Research and Intervention on Suicide, Ethical Issues and End-of-life practices, Université du Québec à Montréal, 100 rue Sherbrooke Ouest, Montreal, QC, H2X 3P2, Canada, 1 (514) 987 4832, cote.louis-philippe.3@courrier.uqam.ca %K suicide prevention %K public health %K information and communication technology %K digital mental health %K helpline %K digital strategy %K communication technology %K information technology %K suicide %K psychoeducation %K mobile app %K suicide risk %K risk factor %K users %K mental health %K text %K website %K prevention strategy %K prevention %K Google Analytics %K Canada %K Quebec %K questionnaire %K mobile phone %D 2024 %7 6.3.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: In 2017, the Quebec government assigned the Association québécoise de prévention du suicide (AQPS) to develop a digital suicide prevention strategy (DSPS). The AQPS responded by creating a centralized website that provides information on suicide and mental health, identifies at-risk individuals on the internet, and offers direct crisis intervention support via chat and text. Objective: This study aims to evaluate the effectiveness of suicide.ca, Quebec’s DSPS platform. Methods: This study used a cross-sectional descriptive design. The study population comprised internet users from Quebec, Canada, who visited the suicide.ca platform between October 2020 and October 2021. Various data sources, such as Google Analytics, Firebase Console, and Customer Relation Management data, were analyzed to document the use of the platform. To understand the profile of suicide.ca users, frequency analyses were conducted using data from the self-assessment module questionnaires, the intervention service’s triage questionnaire, and the counselors’ intervention reports. The effectiveness of the platform’s promotional activities on social media was assessed by examining traffic peaks. Google Analytics was used to evaluate the effectiveness of AQPS’ strategy for identifying at-risk internet users. The impact of the intervention service was evaluated through an analysis of counselors’ intervention reports and postintervention survey results. Results: The platform received traffic from a diverse range of sources, with promotional efforts on social media directly contributing to the increased traffic. The requirement of a user account posed a barrier to the use of the mobile app, and a triage question that involved personal information led to a substantial number of dropouts during the intervention service triage. AdWords campaigns and fact sheets addressing suicide risk factors played a crucial role in driving traffic to the platform. With regard to the profile of suicide.ca users, the findings revealed that the platform engaged individuals with diverse levels of suicidal risk. Notably, users of the chat service displayed a higher suicide risk than those who used the self-assessment module. Crisis chat counselors reported a positive impact on approximately half of the contacts, and overall, intervention service users expressed satisfaction with the support they received. Conclusions: A centralized digital platform can be used to implement a DSPS, effectively reaching the general population, individuals with risk factors for suicide, and those facing suicidal issues. %M 38446536 %R 10.2196/46195 %U https://formative.jmir.org/2024/1/e46195 %U https://doi.org/10.2196/46195 %U http://www.ncbi.nlm.nih.gov/pubmed/38446536 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e52583 %T Tailoring of Health-Promotion Video Messaging for Reproductive-Aged Women at Risk for Developing Cardiometabolic Disease: Qualitative Focus-Groups Study %A Kent-Marvick,Jacqueline %A Gibson,Bryan %A Bristol,Alycia A %A St Clair,Stephanie %A Simonsen,Sara E %+ College of Nursing, University of Utah, 10 South 2000 East, Salt Lake City, UT, 84112, United States, 1 4356686932, jacqueline.kent-marvick@utah.edu %K cardiometabolic disease %K type 2 diabetes mellitus %K gestational diabetes mellitus %K hypertensive disorder of pregnancy %K prediabetes %K obesity %K women’s health %K lifestyle change %K health promotion technology %K qualitative research %D 2024 %7 5.3.2024 %9 Short Paper %J JMIR Form Res %G English %X Background: Targeting reproductive-aged women at high risk for type 2 diabetes (T2D) provides an opportunity for prevention earlier in the life course. A woman’s experiences during her reproductive years may have a large impact on her future risk of T2D. Her risk is 7 to 10 times higher if she has had gestational diabetes (GDM). Despite these risks, T2D is preventable. Evidence-based programs, such as the National Diabetes Prevention Program (DPP), can reduce the risk of developing T2D by nearly 60%. However, only 0.4% of adults with prediabetes have participated in the DPP to date and reproductive-aged women are 50% less likely to participate than older women. In prior work, our team developed a mobile 360° video to address diabetes risk awareness and promote DPP enrollment among at-risk adults; this video was not designed, however, for reproductive-aged women. Objective: This study aims to obtain feedback from reproductive-aged women with cardiometabolic disease risk about a 360° video designed to promote enrollment in the DPP, and to gather suggestions about tailoring video messages to reproductive-aged women. Methods: Focus groups and a qualitative descriptive approach were used. Women with at least 1 previous pregnancy, aged 18 to 40 years, participated in one of three focus groups stratified by the following health risks: (1) a history of GDM or a hypertensive disorder of pregnancy, (2) a diagnosis of prediabetes, or (3) a BMI classified as obese. Focus-group questions addressed several topics; this report shared findings regarding video feedback. The 3 focus-group discussions were conducted via Zoom and were recorded and transcribed for analysis. Deductive codes were used to identify concepts related to the research question and inductive codes were created for novel insights shared by participants. The codes were then organized into categories and themes. Results: The main themes identified were positive feedback, negative feedback, centering motherhood, and the importance of storytelling. While some participants said the video produced a sense of urgency for health-behavior change, all participants agreed that design changes could improve the video’s motivating effect on health-behavior change in reproductive-aged women. Participants felt a tailored video should recognize the complexities of being a mother and how these dynamics contribute to women’s difficulty engaging in healthy behaviors without stirring feelings of guilt. Women desired a video with a positive, problem-solving perspective, and recommended live links as clickable resources for practical solutions promoting health behavior change. Women suggested using storytelling, both to describe how complications experienced during pregnancy impact long-term health and to motivate health behavior change. Conclusions: Reproductive-aged women require tailored lifestyle-change messaging that addresses barriers commonly encountered by this population (eg, parenting or work responsibilities). Moreover, messaging should prioritize a positive tone that harnesses storytelling and human connection while offering realistic solutions. %M 38441920 %R 10.2196/52583 %U https://formative.jmir.org/2024/1/e52583 %U https://doi.org/10.2196/52583 %U http://www.ncbi.nlm.nih.gov/pubmed/38441920 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56499 %T Telehealth Movement-to-Music With Arm-Based Sprint-Intensity Interval Training to Improve Cardiometabolic Health and Cardiorespiratory Fitness in Children With Cerebral Palsy: Protocol for a Pilot Randomized Controlled Trial %A Lai,Byron %A Oster,Robert A %A Davis,Drew %A Bright,Larsen %A Fisher,Gordon %A Wilroy,Jereme %A Kim,Yumi %A Young,Raven %A Wright,Ashley %A Sinha,Tanvee %A Rimmer,James H %+ Division of Pediatric Rehabilitation Medicine, Department of Pediatrics, University of Alabama at Birmingham, 1720 University Blvd, Birmingham, AL, 35294, United States, 1 205 638 9790 ext 8, byronlai@uab.edu %K disability %K high-intensity %K interval training %K pediatrics %K physical activity %K telehealth %D 2024 %7 5.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Children with mobility disabilities, including those with cerebral palsy, have limited options and limited time to exercise to manage their cardiometabolic health and cardiorespiratory fitness. Regular cardiovascular exercise during childhood is a critical health behavior for preventing health decline in adulthood. Thus, there is an urgent need for accessible, age-appropriate, convenient exercise modalities in this group. Sprint-intensity interval training (SIT), combined with telehealth procedures, may be ideal for children with disabilities. SIT includes repetitive bouts of maximal exercise effort combined with rest periods, which can be effective in eliciting comparable results to moderate-exercise training with very short training durations. Objective: This phase 1 pilot feasibility randomized controlled trial aims to investigate the potential effects of a 12-week SIT program on indicators of cardiorespiratory fitness and cardiometabolic health among children with cerebral palsy. An ancillary aim is to evaluate the feasibility of the program through several process feasibility metrics. Methods: This study uses a 2-armed parallel group design. A total of 50 physically inactive children with cerebral palsy (aged 6-17 years) will be randomly allocated into 1 of 2 groups: a 12-week SIT or a waitlist control group that continues habitual activity for 12 weeks. The SIT prescription includes 3 tele-supervised sessions per week with 30 repeated sequences of 4 seconds of maximal arm exercise, with active recovery, warm-up, and cooldown periods (for an approximately 20-minute total session). SIT includes guided videos with child-themed arm routines and music. The exercise sessions will be remotely supervised through a web-based videoconference application and include safety monitoring equipment. Outcomes are measured at pre- and postintervention (weeks 0 and 13, respectively). Health outcome measures include peak oxygen consumption (VO2 peak), measured by a graded exercise test; high-sensitivity C-reactive protein and blood insulin, hemoglobin A1c, triglycerides, and cholesterol using a finger stick dried blood spot test; blood pressure, using a sphygmomanometer; and body composition (total mass, total lean mass, tissue % lean, and tissue % fat) using dual x-ray absorptiometry. Feasibility will be evaluated by the following metrics: adverse events or problems experienced throughout the intervention related to participant safety; perceived enjoyment; and recruitment, enrollment, and attrition rates. Results: Recruitment procedures started in November 2023. All data are anticipated to be collected by February 2025. Full trial results are anticipated to be analyzed and submitted for publication by March 2025. Secondary analyses of data will be subsequently published. Conclusions: This trial tests an accessible and low-cost exercise program that leverages principles of high-intensity exercise to provide a convenient program for children with physical disabilities. Knowledge obtained from this study will inform the development of a larger trial for improving the cardiometabolic health, cardiorespiratory fitness, and well-being of children with physical disabilities. Trial Registration: ClinicalTrials.gov NCT05619211; https://clinicaltrials.gov/study/NCT05619211 International Registered Report Identifier (IRRID): DERR1-10.2196/56499 %M 38441939 %R 10.2196/56499 %U https://www.researchprotocols.org/2024/1/e56499 %U https://doi.org/10.2196/56499 %U http://www.ncbi.nlm.nih.gov/pubmed/38441939 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53282 %T The Effectiveness of a Telenutrition Intervention to Improve Dietary Behavior and Physical Activity Among Adolescents With Obesity: Protocol for a Systematic Review %A Ansari,Muhammad Ridwan %A Kodriati,Nurul %A Pertiwi,Ariani Arista Putri %A Dewi,Fatwa Sari Tetra %+ Department of Health Behavior, Environment and Social Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, IKM building 3rd Fl, Farmako Street, North Sekip, Yogyakarta, 55281, Indonesia, 62 274 551409, fatwasari@ugm.ac.id %K telehealth %K obesity %K telenutrition %K adolescent %K behavior change %K virtual counseling %K teenager %K young adult %K food intake %K dietary pattern %K intervention %D 2024 %7 5.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The global obesity pandemic among adolescents is becoming a public health issue throughout the world. Telehealth use has significantly increased during and after the COVID-19 pandemic, including its application in adolescent obesity prevention and treatment. Objective: This review aims to synthesize the evidence on the effectiveness of telenutrition in improving dietary behavior and physical activity in adolescents with obesity. Methods: The PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols) guideline will be used to structure this protocol. The focus of the systematic review is guided by the population, intervention, comparator, and outcome (PICO) framework. A systematic search of Science Direct, PubMed, Cochrane, Embase, JMIR, ProQuest, and Google scholar databases will be conducted. Two authors will screen the titles and abstracts of identified studies independently and select studies according to the eligibility criteria. The full-text reading will be done independently by 2 reviewers to assess final eligibility. Any discrepancies will then be discussed and resolved. The Cochrane Collaboration Risk of Bias tool was used to assess the risk of bias; a descriptive analysis will summarize the effectiveness of the telenutrition or any type of telehealth intervention used. Results: The systematic review is expected to be completed by the end of March 2024. The ongoing screening and review of the articles are currently being conducted. Conclusions: This systematic review aims to summarize the effectiveness, features, design process, usability, and coherence of a telenutrition intervention using behavior change theory to improve dietary patterns and physical activity among adolescents with obesity. It will identify areas for improvement and best practices, informing the development of more useful and engaging telenutrition interventions for adolescents. Trial Registration: PROSPERO CRD42023458336; http://tinyurl.com/cp46fjj9 International Registered Report Identifier (IRRID): DERR1-10.2196/53282 %M 38441950 %R 10.2196/53282 %U https://www.researchprotocols.org/2024/1/e53282 %U https://doi.org/10.2196/53282 %U http://www.ncbi.nlm.nih.gov/pubmed/38441950 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53001 %T Layperson-Supported, Web-Delivered Cognitive Behavioral Therapy for Depression in Older Adults: Randomized Controlled Trial %A Xiang,Xiaoling %A Kayser,Jay %A Turner,Skyla %A Ash,Samson %A Himle,Joseph A %+ School of Social Work, University of Michigan, 1080 S University Ave, Ann Arbor, MI, 48109, United States, 1 (734) 763 6581, xiangxi@umich.edu %K internet-based cognitive behavioral therapy %K iCBT %K digital mental health interventions %K older adults %K depression %D 2024 %7 4.3.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression is the most prevalent mental health condition in older adults. However, not all evidence-based treatments are easily accessible. Web-delivered cognitive behavioral therapy (wCBT) facilitated by laypersons is a viable treatment alternative. Objective: This randomized controlled trial aims to evaluate the efficacy of a novel wCBT program, Empower@Home, supported by trained lay coaches, against a waitlist attention control. Empower@Home is among the very few existing wCBT programs specifically designed for older adults. The primary objective was to assess the efficacy of the intervention compared with attention control. The secondary objective was to evaluate the program’s impact on secondary psychosocial outcomes and explore potential change mechanisms. Methods: Older adults (N=70) were recruited via web-based research registries, social media advertisements, and community agency referrals and randomly assigned to either the intervention or control group in a 1:1 allocation ratio. The intervention group received access to Empower@Home, which included 9 web-delivered self-help lessons and weekly telephone coaching sessions by a trained layperson over 10 weeks. The control group received weekly friendly phone calls and depressive symptom monitoring. The primary clinical outcome was the severity of depressive symptoms assessed using the Patient Health Questionnaire-9. The secondary clinical outcomes included anxiety, anger, social isolation, insomnia, pain intensity, and quality of life. Linear mixed modeling was used to determine the treatment effects on depression, and 2-tailed t tests were used to assess within-group changes and between-group differences. Results: Most participants in the intervention group completed all 9 sessions (31/35, 89%). The usability and acceptability ratings were excellent. The intervention group had a large within-group change in depressive symptoms (Cohen d=1.22; P<.001), whereas the attention control group experienced a medium change (Cohen d=0.57; P<.001). The between-group effect size was significant, favoring the intervention group over the control group (Cohen d=0.72; P<.001). In the linear mixed model, the group-by-time interaction was statistically significant (b=–0.68, 95% CI –1.00 to –0.35; P<.001). The treatment effects were mediated by improvements in cognitive behavioral therapy skills acquisition; behavioral activation; and satisfaction with the basic psychological needs of autonomy, competence, and relatedness. Furthermore, the intervention group showed significant within-group improvements in secondary psychosocial outcomes, including anxiety (P=.001), anger (P<.001), social isolation (P=.02), insomnia (P=.007), and pain (P=.03). By contrast, the control group did not experience significant changes in these outcome domains. However, the between-group differences in secondary outcomes were not statistically significant, owing to the small sample size. Conclusions: Empower@Home, a wCBT program supported by lay coaches, was more efficacious in reducing depressive symptoms than friendly telephone calls and depression symptom monitoring. Future studies should examine the effectiveness of the intervention in community and practice settings using nonclinician staff already present in these real-world settings as coaches. Trial Registration: ClinicalTrials.gov NCT05593276; https://clinicaltrials.gov/ct2/show/NCT05593276 International Registered Report Identifier (IRRID): RR2-10.2196/44210 %M 38437013 %R 10.2196/53001 %U https://www.jmir.org/2024/1/e53001 %U https://doi.org/10.2196/53001 %U http://www.ncbi.nlm.nih.gov/pubmed/38437013 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e55003 %T Evaluation of Patient-Facing Mobile Apps to Support Physiotherapy Care: Systematic Review %A Merolli,Mark %A Francis,Jill J %A Vallance,Patrick %A Bennell,Kim L %A Malliaras,Peter %A Hinman,Rana S %+ Centre for Health, Exercise & Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, 161 Barry Street, Parkville, Melbourne, 3052, Australia, 61 383443689, merollim@unimelb.edu.au %K physiotherapy %K physical therapy %K digital health intervention %K mobile app %K behavior change technique %K behavior change %K exercise %K systematic review %K quality %K rehabilitation %K BCT %K mHealth %K mobile health %K app %K apps %K physical activity %K fitness %K synthesis %K syntheses %K review methods %K review methodology %K search %K searches %K searching %K systematic %K mobile phone %D 2024 %7 4.3.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mobile health interventions delivered through mobile apps are increasingly used in physiotherapy care. This may be because of the potential of apps to facilitate changes in behavior, which is central to the aims of care delivered by physiotherapists. A benefit of using apps is their ability to incorporate behavior change techniques (BCTs) that can optimize the effectiveness of physiotherapeutic interventions. Research continues to suggest that despite their importance, behavior change strategies are often missing in patient management. Evaluating mobile apps that physiotherapists can use to drive behavior change may inform clinical practice and potentially improve patient outcomes. Examining the quality of apps and exploring their key features that can support behavior change and physiotherapy care are important aspects of such an evaluation. Objective: The primary aim of this study was to describe the range of mobile apps in app stores that are intended for use by patients to support physiotherapy care. The secondary aims were to assess app quality, BCTs, and their behavior change potential. Methods: A systematic review of mobile apps in app stores was undertaken. The Apple App Store and Google Play were searched using a 2-step search strategy, using terms relevant to the physiotherapy discipline. Strict inclusion and exclusion criteria were applied: apps had to be intended for use by patients and be self-contained (or stand-alone) without the requirement to be used in conjunction with a partner wearable device or another plugin. Included apps were coded for BCTs using the Behavior Change Technique Taxonomy version 1. App quality was assessed using the Mobile App Rating Scale, and the App Behavior Change Scale was used to assess the app’s potential to change behavior. Results: In total, 1240 apps were screened, and 35 were included. Of these 35 apps, 22 (63%) were available on both the Apple App Store and Google Play platforms. In total, 24 (69%) were general in their focus (eg, not condition-specific), with the remaining 11 (31%) being more specific (eg, knee rehabilitation and pelvic floor training). The mean app quality score (Mobile App Rating Scale) was 3.7 (SD 0.4) of 5 (range 2.8-4.5). The mean number of BCTs identified per app was 8.5 (SD 3.6). BCTs most frequently included in the apps were instruction on how to perform a behavior (n=32), action planning (n=30), and self-monitoring of behavior (n=28). The mean behavior change potential score (App Behavior Change Scale) was 8.5 (SD 3.1) of 21 (range 3-15). Conclusions: Mobile apps available to support patient care received from a physiotherapist are of variable quality. Although they contain some BCTs, the potential for behavior change varied widely across apps. International Registered Report Identifier (IRRID): RR2-10.2196/29047 %M 38437018 %R 10.2196/55003 %U https://mhealth.jmir.org/2024/1/e55003 %U https://doi.org/10.2196/55003 %U http://www.ncbi.nlm.nih.gov/pubmed/38437018 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e40187 %T Efficacy of Internet-Based Cognitive Behavioral Therapy for Subthreshold Depression Among Older Adults in Institutional Long-Term Care Settings: Pragmatic Randomized Controlled Trial %A Kong,Fanqian %A Yu,Libo %A Hou,Yanbin %A Zhu,Lijie %A Zhou,Jing %A Huang,Lingjie %A Lv,Yueer %A Wang,Li %A Zhang,Li %A Yang,Yiling %A Ying,Yuchen %+ Ningbo College of Health Sciences, 51 Xuefu Street, Yinzhou District, Ningbo, Zhejiang, 315100, China, 86 13685733802, 1246401741@qq.com %K internet-based cognitive behavioral therapy %K subthreshold depression %K randomized controlled trial %K older adults %K LTC setting %D 2024 %7 1.3.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Subthreshold depression (sD) is prevalent in older populations in long-term care (LTC) settings, but psychological therapy in LTC settings in China is not readily available. Thus, internet-based cognitive behavioral therapy (ICBT) may be suitable for this population, but research on the efficacy of ICBT for older adults with sD, especially those living in LTC settings, is limited. Objective: This study aimed to evaluate the efficacy and acceptability of ICBT treatment for sD among LTC residents in China. We also examined whether ICBT is as effective as group-based cognitive behavioral therapy (CBT) for treating sD in this population. Methods: We conducted a pragmatic randomized controlled trial, which included 18 LTC institutions. A total of 354 participants were randomized to ICBT, group-based CBT, or a waiting list and were followed up for 12 months. The primary outcome was self-reported depressive symptoms on the Center for Epidemiological Studies Depression Scale (CES-D). Secondary outcomes were the scores of the Patient Health Questionnaire–9 (PHQ-9), Generalized Anxiety Disorder 7-Item (GAD-7), and Geriatric Depression Scale (GDS). A mixed-effects model was used to assess the efficacy of ICBT. Results: The ICBT group showed a significant improvement in self-reported depressive symptoms, which was maintained at the 12-month follow-up (all P<.001). The ICBT group exhibited a significantly larger reduction in the scores of the CES-D (Cohen d=0.07, 95% CI 0.04-0.09; P=.01), PHQ-9 (d=0.30, 95% CI 0.28-0.33; P<.001), GDS (d=0.10, 95% CI 0.08-0.13; P<.001), and GAD-7 (d=0.19, 95% CI 0.17-0.22; P<.001) compared with a waiting list at postintervention. ICBT had significantly stronger effects than CBT on the PHQ-9 and GAD-7 at postintervention (d=0.15, 95% CI 0.13-0.17; P<.001 and d=0.21, 95% CI 0.19-0.23; P<.001, respectively), 6-month follow-up (d=0.18, 95% CI 0.16-0.21; P<.001 and d=0.18, 95% CI 0.15-0.21; P<.001, respectively), and 12-month follow-up (d=0.15, 95% CI 0.11-0.19; P<.001 and d=0.18, 95% CI 0.14-0.21; P<.001, respectively). Conclusions: ICBT is a relatively effective and acceptable intervention for reducing depressive symptoms among Chinese LTC residents with sD. These findings indicate the usefulness of ICBT application for sD in LTC settings. Trial Registration: Chinese Clinical Trial Registry ChiCTR2000030697; https://www.chictr.org.cn/showproj.aspx?proj=50781 %M 38427424 %R 10.2196/40187 %U https://www.jmir.org/2024/1/e40187 %U https://doi.org/10.2196/40187 %U http://www.ncbi.nlm.nih.gov/pubmed/38427424 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e48883 %T Assessing the Effectiveness of STAPP@Work, a Self-Management Mobile App, in Reducing Work Stress and Preventing Burnout: Single-Case Experimental Design Study %A Demirel,Sevda %A Roke,Yvette %A Hoogendoorn,Adriaan W %A Hoefakker,Jamie %A Hoeberichts,Kirsten %A van Harten,Peter N %+ Expertise Center for Autism Spectrum Disorder, GGz Centraal, Boomgaardweg 12, Almere, 1326 AD, Netherlands, 31 41807329, S.demirel@ggzcentraal.nl %K mental health %K stress %K coping %K burnout %K stress management %K digital intervention %K health promotion %K mobile apps %K mobile health %K mHealth %K mental health professionals %D 2024 %7 29.2.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Work-related stress and burnout remain common problems among employees, leading to impaired health and higher absenteeism. The use of mobile health apps to promote well-being has grown substantially; however, the impact of such apps on reducing stress and preventing burnout is limited. Objective: This study aims to assess the effectiveness of STAPP@Work, a mobile-based stress management intervention, on perceived stress, coping self-efficacy, and the level of burnout among mental health employees. Methods: The study used a single-case experimental design to examine the use of STAPP@Work among mental health employees without a known diagnosis of burnout (N=63). Participants used the app for 1 week per month repeatedly for a period of 6 months. Using a reversal design, the participants used the app 6 times to assess replicated immediate (1 week after use) and lasting (3 weeks after use) effects. The Perceived Stress Scale, the Coping Self-Efficacy Scale, and the Burnout Assessment Tool were used to measure the outcomes. Linear mixed models were used to analyze the data. Results: After 6 months of app use for 1 week per month, the participants showed a statistically significant decrease in perceived stress (b=–0.38, 95% CI –0.67 to –0.09; P=.01; Cohen d=0.50) and burnout symptoms (b=–0.31, 95% CI –0.51 to –0.12; P=.002; Cohen d=0.63) as well as a statistically significant improvement in problem-focused coping self-efficacy (b=0.42, 95% CI 0-0.85; P=.049; Cohen d=0.42). Long-term use of the app provided consistent reductions in burnout symptoms over time, including in the level of exhaustion and emotional impairment. Conclusions: The use of an app-based stress management intervention has been shown to reduce burnout symptoms and enhance coping self-efficacy among mental health workers. Prevention of burnout and minimization of work-related stress are of utmost importance to protect employee health and reduce absenteeism. %M 38275128 %R 10.2196/48883 %U https://www.jmir.org/2024/1/e48883 %U https://doi.org/10.2196/48883 %U http://www.ncbi.nlm.nih.gov/pubmed/38275128 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e51268 %T The Effect of Digital Mental Health Literacy Interventions on Mental Health: Systematic Review and Meta-Analysis %A Yeo,GeckHong %A Reich,Stephanie M %A Liaw,Nicole A %A Chia,Elizabeth Yee Min %+ School of Education, University of California, Irvine, 3454 Education, Irvine, CA, 92697, United States, 1 (949) 824 5970, smreich@uci.edu %K review and meta-analysis %K digital mental health literacy %K digital mental health interventions %K mental health functioning %D 2024 %7 29.2.2024 %9 Review %J J Med Internet Res %G English %X Background: Accelerated by technological advancements and the recent global pandemic, there is burgeoning interest in digital mental health literacy (DMHL) interventions that can positively affect mental health. However, existing work remains inconclusive regarding the effectiveness of DMHL interventions. Objective: This systematic review and meta-analysis investigated the components and modes of DMHL interventions, their moderating factors, and their long-term impacts on mental health literacy and mental health. Methods: We used a random-effects model to conduct meta-analyses and meta-regressions on moderating effects of DMHL interventions on mental health. Results: Using 144 interventions with 206 effect sizes, we found a moderate effect of DMHL interventions in enhancing distal mental health outcomes (standardized mean difference=0.42, 95% CI −0.10 to 0.73; P<.001) and a large effect in increasing proximal mental health literacy outcomes (standardized mean difference=0.65, 95% CI 0.59-0.74; P<.001). Uptake of DMHL interventions was comparable with that of control conditions, and uptake of DMHL interventions did not moderate the effects on both proximal mental health literacy outcomes and distal mental health outcomes. DMHL interventions were as effective as face-to-face interventions and did not differ by platform type or dosage. DMHL plus interventions (DMHL psychoeducation coupled with other active treatment) produced large effects in bolstering mental health, were more effective than DMHL only interventions (self-help DMHL psychoeducation), and were comparable with non-DMHL interventions (treatment as usual). DMHL interventions demonstrated positive effects on mental health that were sustained over follow-up assessments and were most effective in enhancing the mental health of emerging and older adults. Conclusions: For theory building, our review and meta-analysis found that DMHL interventions are as effective as face-to-face interventions. DMHL interventions confer optimal effects on mental health when DMHL psychoeducation is combined with informal, nonprofessional active treatment components such as skills training and peer support, which demonstrate comparable effectiveness with that of treatment as usual (client-professional interactions and therapies). These effects, which did not differ by platform type or dosage, were sustained over time. Additionally, most DMHL interventions are found in Western cultural contexts, especially in high-income countries (Global North) such as Australia, the United States, and the United Kingdom, and limited research is conducted in low-income countries in Asia and in South American and African countries. Most of the DMHL studies did not report information on the racial or ethnic makeup of the samples. Future work on DMHL interventions that target racial or ethnic minority groups, particularly the design, adoption, and evaluation of the effects of culturally adaptive DMHL interventions on uptake and mental health functioning, is needed. Such evidence can drive the adoption and implementation of DMHL interventions at scale, which represents a key foundation for practice-changing impact in the provision of mental health resources for individuals and the community. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42023363995; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023363995 %M 38421687 %R 10.2196/51268 %U https://www.jmir.org/2024/1/e51268 %U https://doi.org/10.2196/51268 %U http://www.ncbi.nlm.nih.gov/pubmed/38421687 %0 Journal Article %@ 2369-3762 %I JMIR Publications %V 10 %N %P e51426 %T Exploring the Feasibility of Using ChatGPT to Create Just-in-Time Adaptive Physical Activity mHealth Intervention Content: Case Study %A Willms,Amanda %A Liu,Sam %+ School of Exercise Science, Physical and Health Education, University of Victoria, PO Box 3010 STN CSC, Victoria, BC, V8W 2Y2, Canada, 1 250 721 8392, awillms@uvic.ca %K ChatGPT %K digital health %K mobile health %K mHealth %K physical activity %K application %K mobile app %K mobile apps %K content creation %K behavior change %K app design %D 2024 %7 29.2.2024 %9 Original Paper %J JMIR Med Educ %G English %X Background: Achieving physical activity (PA) guidelines’ recommendation of 150 minutes of moderate-to-vigorous PA per week has been shown to reduce the risk of many chronic conditions. Despite the overwhelming evidence in this field, PA levels remain low globally. By creating engaging mobile health (mHealth) interventions through strategies such as just-in-time adaptive interventions (JITAIs) that are tailored to an individual’s dynamic state, there is potential to increase PA levels. However, generating personalized content can take a long time due to various versions of content required for the personalization algorithms. ChatGPT presents an incredible opportunity to rapidly produce tailored content; however, there is a lack of studies exploring its feasibility. Objective: This study aimed to (1) explore the feasibility of using ChatGPT to create content for a PA JITAI mobile app and (2) describe lessons learned and future recommendations for using ChatGPT in the development of mHealth JITAI content. Methods: During phase 1, we used Pathverse, a no-code app builder, and ChatGPT to develop a JITAI app to help parents support their child’s PA levels. The intervention was developed based on the Multi-Process Action Control (M-PAC) framework, and the necessary behavior change techniques targeting the M-PAC constructs were implemented in the app design to help parents support their child’s PA. The acceptability of using ChatGPT for this purpose was discussed to determine its feasibility. In phase 2, we summarized the lessons we learned during the JITAI content development process using ChatGPT and generated recommendations to inform future similar use cases. Results: In phase 1, by using specific prompts, we efficiently generated content for 13 lessons relating to increasing parental support for their child’s PA following the M-PAC framework. It was determined that using ChatGPT for this case study to develop PA content for a JITAI was acceptable. In phase 2, we summarized our recommendations into the following six steps when using ChatGPT to create content for mHealth behavior interventions: (1) determine target behavior, (2) ground the intervention in behavior change theory, (3) design the intervention structure, (4) input intervention structure and behavior change constructs into ChatGPT, (5) revise the ChatGPT response, and (6) customize the response to be used in the intervention. Conclusions: ChatGPT offers a remarkable opportunity for rapid content creation in the context of an mHealth JITAI. Although our case study demonstrated that ChatGPT was acceptable, it is essential to approach its use, along with other language models, with caution. Before delivering content to population groups, expert review is crucial to ensure accuracy and relevancy. Future research and application of these guidelines are imperative as we deepen our understanding of ChatGPT and its interactions with human input. %M 38421689 %R 10.2196/51426 %U https://mededu.jmir.org/2024/1/e51426 %U https://doi.org/10.2196/51426 %U http://www.ncbi.nlm.nih.gov/pubmed/38421689 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e47458 %T Using a Novel Gameplay Intervention to Target Intrusive Memories After Work-Related Trauma: Iterative Qualitative Analysis of Intensive Care Unit Staff Experiences %A Patel,Priya %A Brown,Susan %A Guo,Boliang %A Holmes,Emily A %A Iyadurai,Lalitha %A Kingslake,Jonathan %A Highfield,Julie %A Morriss,Richard %+ NIHR ARC East Midlands, University of Nottingham, Innovation Park Jubilee Campus, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, United Kingdom, 44 7790988203, Priya.Patel1@nottingham.ac.uk %K intensive care %K posttraumatic stress disorder %K PTSD %K qualitative research %K intervention study %K health care professionals %K digital intervention %K staff well-being %K pandemic %K intrusive memories %K work-related trauma %K mobile phone %D 2024 %7 29.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Many intensive care unit (ICU) staff experience intrusive memories following work-related traumatic events, which can lead to long-term mental health outcomes and impact work functioning. There is a need for interventions that target intrusive memories in this population; however, factors such as mental health stigma and difficulty in fitting interventions into busy schedules can pose barriers. The Brief Gameplay Intervention For National Health Service Intensive Care Unit Staff Affected By COVID-19 Trauma (GAINS) study tested a brief, digital imagery-competing task intervention (including computer gameplay) with the aim of reducing the recurrence of intrusive memories, which holds promise for overcoming some of these barriers. Objective: This substudy aims to explore barriers and facilitators to the uptake and practical use of the intervention by ICU staff, along with its acceptability, and iteratively explore the impact of intervention optimizations to further refine the intervention. Methods: The GAINS study is a randomized controlled trial comparing access to a brief digital imagery-competing task intervention for 4 weeks with usual care followed by delayed access to the intervention. The participants were ICU staff who worked during the COVID-19 pandemic and experienced intrusive memories. All participants were sent a questionnaire at 4 weeks to gather data about intervention acceptability. Nested within the randomized controlled trial, a subset of 16 participants was interviewed, and data were analyzed using thematic analysis drawing from a framework approach. Results: Both quantitative and qualitative data indicated high acceptability of the intervention. Intervention use data show that, on average, staff were able to target approximately 73% (3.64/4.88) of their intrusive memories and engaged with the Tetris component for the full 20 minutes per session. Overall, on the acceptability questionnaire, staff found the intervention easy to use, helpful, and highly acceptable. The interviews generated four themes: approach to the intervention, positives of the intervention, negatives of the intervention, and improvements and optimizations. Findings highlighted barriers that ICU staff experienced: stigma, feeling weak for seeking help, not wanting colleagues to know they were struggling, and skepticism. However, they provided suggestions on how barriers could be overcome and discussed the advantages of the intervention when compared with other treatments. Although participants described many positive aspects of the intervention, such as being easy to use, enjoyable, and leading to a reduction in the frequency or intensity of intrusive memories, they also raised practical issues for implementation. Conclusions: The intervention has the potential to overcome stigma and reduce the frequency of intrusive memories after traumatic events among ICU staff. Further refinement is needed to improve the adoption and reach of this intervention. A limitation is that we could not interview the National Health Service staff who were unable or unwilling to take part in the trial. %M 38421698 %R 10.2196/47458 %U https://formative.jmir.org/2024/1/e47458 %U https://doi.org/10.2196/47458 %U http://www.ncbi.nlm.nih.gov/pubmed/38421698 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e53659 %T Feasibility of Guided Internet-Based Cognitive Behavioral Therapy for Panic Disorder and Social Anxiety Disorder in Japan: Pilot Single-Arm Trial %A Shinno,Seina %A Matsumoto,Kazuki %A Hamatani,Sayo %A Inaba,Yosuke %A Ozawa,Yoshihito %A Kawasaki,Yohei %A Ikai,Tomoki %A Sutoh,Chihiro %A Hayashi,Hiroyuki %A Shimizu,Eiji %+ Division of Clinical Psychology, Kagoshima University Medical and Dental Hospital, 1-35-8 Sakuragaoka, Kagoshima, 8908520, Japan, 81 099 275 5707, k2782199@kadai.jp %K cognitive behavioral therapy %K internet intervention %K panic disorder %K social anxiety %K feasibility trail %K adult %K adults %K anxiety disorder %K internet-based %K e-learning %K Japan %K statistical analyses %K therapist %K therapists %K intervention %K severity %K symptoms %K therapeutic alliance %K mobile phone %D 2024 %7 29.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Cognitive behavioral therapy (CBT) is effective in treating anxiety disorders. Accessibility to CBT has been limited in Japan due to the shortage of therapists. While an open-source e-learning system can be used to create a simple internet-based cognitive behavioral therapy (ICBT) program, the safety and outpatient acceptance of this treatment approach have not been explored in Japan. Objective: The aim of this study was to investigate whether outpatients with anxiety disorders could accept and successfully complete the ICBT program with guidance by CBT therapists when implementing therapeutic modules and CBT tasks. Due to being in the initial phase of a novel treatment in Japan, this study was intended for verification with a small sample size. Methods: In total, 6 adults, including 4 male participants and 2 female participants, were enrolled in a single-arm trial. The intervention involved guided ICBT comprising 12 sessions, including CBT text, comprehension confirmation tests, and explanatory videos about cognitive behavioral models, accessible through a website. The therapist guided the participants in accessing the ICBT program and answering their questions using a chat tool. The primary outcome was anxiety severity assessed using the State-Trait Anxiety Inventory-Trait. Secondary outcomes included the Panic Disorder Severity Scale, Liebowitz Social Anxiety Scale (LSAS), Beck Anxiety Inventory (BAI), Patient Health Questionnaire–9, Generalized Anxiety Disorder–7, and Working Alliance Inventory–Short Form (WAI-SF). Statistical analyses were performed using paired 2-tailed t tests to assess the changes in clinical symptoms. The total WAI-SF score at the final session was used to evaluate the therapeutic alliance. For statistical analyses, mean changes for total State-Trait Anxiety Inventory-Trait, BAI, Panic Disorder Severity Scale, LSAS, Patient Health Questionnaire–9, and Generalized Anxiety Disorder–7 scores were analyzed using the paired 2-tailed t test. The 2-sided significance level for hypothesis testing was set at 5%, and 2-sided 95% CIs were calculated. Results: Most participants diligently engaged with the ICBT program. No adverse events were reported. The mean total scores for the primary outcome decreased by 11.0 (SD 9.6) points (95% CI –22.2 to 0.20; Hedges g=0.95), but it was not statistically significant. The mean total scores for the secondary outcomes that assess clinical symptoms decreased, with a significant reduction observed in the BAI of 15.7 (SD 12.1) points (95% CI –28.4 to –3.0; P=.03; Hedges g=1.24). The mean total scores for PDSS and LSAS decreased significantly, by 12.0 (SD 4.24) points (95% CI –50.1 to 26.1; P=.16; Hedges g=1.79) and 32.4 (SD 11.1) points (95% CI –59.7 to –4.3; P=.04; Hedges g=1.38), respectively. Of the participants, 67% (n=4) showed treatment response, and 50% (n=3) achieved remission after the intervention. The therapeutic alliance, measured using the WAI-SF, was moderate. Conclusions: Guided ICBT may be feasible for the treatment of outpatients with panic disorder and social anxiety disorder in Japan. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN0000038118; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000043439 %M 38421717 %R 10.2196/53659 %U https://formative.jmir.org/2024/1/e53659 %U https://doi.org/10.2196/53659 %U http://www.ncbi.nlm.nih.gov/pubmed/38421717 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e48147 %T Action Opportunities to Pursue Responsible Digital Care for People With Intellectual Disabilities: Qualitative Study %A Siebelink,Nienke M %A van Dam,Kirstin N %A Lukkien,Dirk R M %A Boon,Brigitte %A Smits,Merlijn %A van der Poel,Agnes %+ Academy Het Dorp, Kemperbergerweg 139e, Arnhem, 6816RP, Netherlands, 31 0651656387, nienke.siebelink@academyhetdorp.nl %K ethics %K value-based health care %K digital technology %K intellectual disability %K digital care %D 2024 %7 28.2.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Responsible digital care refers to any intentional systematic effort designed to increase the likelihood of a digital care technology developed through ethical decision-making, being socially responsible and aligned with the values and well-being of those impacted by it. Objective: We aimed to present examples of action opportunities for (1) designing “technology”; (2) shaping the “context” of use; and (3) adjusting the behavior of “users” to guide responsible digital care for people with intellectual disabilities. Methods: Three cases were considered: (1) design of a web application to support the preparation of meals for groups of people with intellectual disabilities, (2) implementation of an app to help people with intellectual disabilities regulate their stress independently, and (3) implementation of a social robot to stimulate interaction and physical activity among people with intellectual disabilities. Overall, 26 stakeholders participated in 3 multistakeholder workshops (case 1: 10/26, 38%; case 2: 10/26, 38%; case 3: 6/26, 23%) based on the “guidance ethics approach.” We identified stakeholders’ values based on bottom-up exploration of experienced and expected effects of using the technology, and we formulated action opportunities for these values in the specific context of use. Qualitative data were analyzed thematically. Results: Overall, 232 effects, 33 values, and 156 action opportunities were collected. General and case-specific themes were identified. Important stakeholder values included quality of care, autonomy, efficiency, health, enjoyment, reliability, and privacy. Both positive and negative effects could underlie stakeholders’ values and influence the development of action opportunities. Action opportunities comprised the following: (1) technology: development of the technology (eg, user experience and customization), technology input (eg, recipes for meals, intervention options for reducing stress, and activities), and technology output (eg, storage and use of data); (2) context: guidelines, training and support, policy or agreements, and adjusting the physical environment in which the technology is used; and (3) users: integrating the technology into daily care practice, by diminishing (eg, “letting go” to increase the autonomy of people with intellectual disabilities), retaining (eg, face-to-face contact), and adding (eg, evaluation moments) certain behaviors of care professionals. Conclusions: This is the first study to provide insight into responsible digital care for people with intellectual disabilities by means of bottom-up exploration of action opportunities to take account of stakeholders’ values in designing technology, shaping the context of use, and adjusting the behavior of users. Although part of the findings may be generalized, case-specific insights and a complementary top-down approach (eg, predefined ethical frameworks) are essential. The findings represent a part of an ethical discourse that requires follow-up to meet the dynamism of stakeholders’ values and further develop and implement action opportunities to achieve socially desirable, ethically acceptable, and sustainable digital care that improves the lives of people with intellectual disabilities. %M 38416547 %R 10.2196/48147 %U https://mental.jmir.org/2024/1/e48147 %U https://doi.org/10.2196/48147 %U http://www.ncbi.nlm.nih.gov/pubmed/38416547 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e48168 %T Attrition in Conversational Agent–Delivered Mental Health Interventions: Systematic Review and Meta-Analysis %A Jabir,Ahmad Ishqi %A Lin,Xiaowen %A Martinengo,Laura %A Sharp,Gemma %A Theng,Yin-Leng %A Tudor Car,Lorainne %+ Lee Kong Chian School of Medicine, Nanyang Technological University Singapore, 11 Mandalay Road, Level 18, Singapore, 308232, Singapore, 65 69041258, lorainne.tudor.car@ntu.edu.sg %K conversational agent %K chatbot %K mental health %K mHealth %K attrition %K dropout %K mobile phone %K artificial intelligence %K AI %K systematic review %K meta-analysis %K digital health interventions %D 2024 %7 27.2.2024 %9 Review %J J Med Internet Res %G English %X Background: Conversational agents (CAs) or chatbots are computer programs that mimic human conversation. They have the potential to improve access to mental health interventions through automated, scalable, and personalized delivery of psychotherapeutic content. However, digital health interventions, including those delivered by CAs, often have high attrition rates. Identifying the factors associated with attrition is critical to improving future clinical trials. Objective: This review aims to estimate the overall and differential rates of attrition in CA-delivered mental health interventions (CA interventions), evaluate the impact of study design and intervention-related aspects on attrition, and describe study design features aimed at reducing or mitigating study attrition. Methods: We searched PubMed, Embase (Ovid), PsycINFO (Ovid), Cochrane Central Register of Controlled Trials, and Web of Science, and conducted a gray literature search on Google Scholar in June 2022. We included randomized controlled trials that compared CA interventions against control groups and excluded studies that lasted for 1 session only and used Wizard of Oz interventions. We also assessed the risk of bias in the included studies using the Cochrane Risk of Bias Tool 2.0. Random-effects proportional meta-analysis was applied to calculate the pooled dropout rates in the intervention groups. Random-effects meta-analysis was used to compare the attrition rate in the intervention groups with that in the control groups. We used a narrative review to summarize the findings. Results: The systematic search retrieved 4566 records from peer-reviewed databases and citation searches, of which 41 (0.90%) randomized controlled trials met the inclusion criteria. The meta-analytic overall attrition rate in the intervention group was 21.84% (95% CI 16.74%-27.36%; I2=94%). Short-term studies that lasted ≤8 weeks showed a lower attrition rate (18.05%, 95% CI 9.91%- 27.76%; I2=94.6%) than long-term studies that lasted >8 weeks (26.59%, 95% CI 20.09%-33.63%; I2=93.89%). Intervention group participants were more likely to attrit than control group participants for short-term (log odds ratio 1.22, 95% CI 0.99-1.50; I2=21.89%) and long-term studies (log odds ratio 1.33, 95% CI 1.08-1.65; I2=49.43%). Intervention-related characteristics associated with higher attrition include stand-alone CA interventions without human support, not having a symptom tracker feature, no visual representation of the CA, and comparing CA interventions with waitlist controls. No participant-level factor reliably predicted attrition. Conclusions: Our results indicated that approximately one-fifth of the participants will drop out from CA interventions in short-term studies. High heterogeneities made it difficult to generalize the findings. Our results suggested that future CA interventions should adopt a blended design with human support, use symptom tracking, compare CA intervention groups against active controls rather than waitlist controls, and include a visual representation of the CA to reduce the attrition rate. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42022341415; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022341415 %M 38412023 %R 10.2196/48168 %U https://www.jmir.org/2024/1/e48168 %U https://doi.org/10.2196/48168 %U http://www.ncbi.nlm.nih.gov/pubmed/38412023 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e55560 %T Rates of Trauma Exposure and Posttraumatic Stress in a Pediatric Digital Mental Health Intervention: Retrospective Analysis of Associations With Anxiety and Depressive Symptom Improvement Over Time %A Lawrence-Sidebottom,Darian %A Huffman,Landry Goodgame %A Beam,Aislinn Brenna %A Guerra,Rachael %A Parikh,Amit %A Roots,Monika %A Huberty,Jennifer %+ Bend Health Inc, 2801 Marshall Ct, Madison, WI, 53705, United States, 1 8005160975, darian.lawrence@bendhealth.com %K collaborative care model %K telehealth %K childhood trauma %K DMHI %K digital health %K mental health %K telemedicine %K trauma %K traumatic %K pediatric %K pediatrics %K paediatric %K paediatrics %K child %K children %K youth %K adolescent %K adolescents %K teen %K teens %K teenager %K teenagers %K retrospective %K anxiety %K depression %K depressive %K co-occurring %K comorbid %K comorbidity %K comorbidities %K association %K associations %K correlation %K correlations %K correlate %D 2024 %7 27.2.2024 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: More than 2 out of 3 children and adolescents in the United States experience trauma by the age of 16 years. Exposure to trauma in early life is linked to a range of negative mental health outcomes throughout the lifespan, particularly co-occurring symptoms of posttraumatic stress (PTS), anxiety, and depression. There has been an increasing uptake of digital mental health interventions (DMHIs) among youths, particularly for anxiety and depression. However, little is known regarding the incidence of trauma exposure and PTS symptoms among youths participating in DMHIs and whether PTS symptoms impact anxiety and depressive symptom treatment response. Moreover, it is unclear whether participation in a DMHI for anxiety and depressive symptoms is associated with secondary effects on PTS symptoms among trauma-exposed youths. Objective: This study aims to use retrospective data from youths participating in a DMHI to (1) characterize rates of trauma, PTS, and comorbid anxiety and depressive symptoms; (2) determine whether trauma exposure and elevated PTS symptoms impact the improvement of comorbid anxiety and depressive symptoms throughout participation in care; and (3) determine whether participation in a non–posttraumatic DMHI is linked to reductions in PTS symptoms. Methods: This study was conducted using retrospective data from members (children ages 6 to 12 years) involved in a pediatric collaborative care DMHI. Participating caregivers reported their children’s trauma exposure. PTS, anxiety, and depressive symptom severity were measured monthly using validated assessments. Results: Among eligible participants (n=966), 30.2% (n=292) reported at least 1 traumatic event. Of those with trauma exposure and elevated symptoms of PTS (n=119), 73% (n=87) exhibited elevated anxiety symptoms and 50% (n=59) exhibited elevated depressive symptoms. Compared to children with no trauma, children with elevated PTS symptoms showed smaller reductions per month in anxiety but not depressive symptoms (anxiety: F2,287=26.11; P<.001). PTS symptoms also decreased significantly throughout care, with 96% (n=79) of participants showing symptom reductions. Conclusions: This study provides preliminary evidence for the frequency of trauma exposure and comorbid psychiatric symptoms, as well as variations in treatment response between trauma-exposed and nontrauma-exposed youths, among participants in a pediatric collaborative care DMHI. Youths with traumatic experiences may show increased psychiatric comorbidities and slower treatment responses than their peers with no history of trauma. These findings deliver compelling evidence that collaborative care DMHIs may be well-suited to address mental health symptoms in children with a history of trauma while also highlighting the critical need to assess symptoms of PTS in children seeking treatment. %M 38412001 %R 10.2196/55560 %U https://pediatrics.jmir.org/2024/1/e55560 %U https://doi.org/10.2196/55560 %U http://www.ncbi.nlm.nih.gov/pubmed/38412001 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e48954 %T Designing and Validating a Novel Method for Assessing Delay Discounting Associated With Health Behaviors: Ecological Momentary Assessment Study %A Luken,Amanda %A Rabinowitz,Jill A %A Wells,Jonathan L %A Sosnowski,David W %A Strickland,Justin C %A Thrul,Johannes %A Kirk,Gregory D %A Maher,Brion S %+ Department of Mental Health, Bloomberg School of Public Health, Johns Hopkins University, 624 N Broadway, Baltimore, MD, 212055, United States, 1 4432878287, brion@jhu.edu %K delay discounting %K measurement %K Monetary Choice Questionnaire %K ecological momentary assessment %K substance use %K substance abuse %K questionnaire %K validity %K validation %K measurement %K monetary %K reward %K rewards %K survey %K mobile phone %D 2024 %7 27.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Delay discounting quantifies an individual’s preference for smaller, short-term rewards over larger, long-term rewards and represents a transdiagnostic factor associated with numerous adverse health outcomes. Rather than a fixed trait, delay discounting may vary over time and place, influenced by individual and contextual factors. Continuous, real-time measurement could inform adaptive interventions for various health conditions. Objective: The goals of this paper are 2-fold. First, we present and validate a novel, short, ecological momentary assessment (EMA)–based delay discounting scale we developed. Second, we assess this tool’s ability to reproduce known associations between delay discounting and health behaviors (ie, substance use and craving) using a convenience-based sample. Methods: Participants (N=97) were adults (age range 18-71 years), recruited on social media. In phase 1, data were collected on participant sociodemographic characteristics, and delay discounting was evaluated via the traditional Monetary Choice Questionnaire (MCQ) and our novel method (ie, 7-item time-selection and 7-item monetary-selection scales). During phase 2 (approximately 6 months later), participants completed the MCQ, our novel delay discounting measures, and health outcomes questions. The correlations between our method and the traditional MCQ within and across phases were examined. For scale reduction, a random number of items were iteratively selected, and the correlation between the full and random scales was assessed. We then examined the association between our time- and monetary-selection scales assessed during phase 2 and the percentage of assessments that participants endorsed using or craving alcohol, tobacco, or cannabis. Results: In total, 6 of the 7 individual time-selection items were highly correlated with the full scale (r>0.89). Both time-selection (r=0.71; P<.001) and monetary-selection (r=0.66; P<.001) delay discounting rates had high test-retest reliability across phases 1 and 2. Phase 1 MCQ delay discounting function highly correlated with phase 1 (r=0.76; P<.001) and phase 2 (r=0.45; P<.001) time-selection delay discounting scales. One or more randomly chosen time-selection items were highly correlated with the full scale (r>0.94). Greater delay discounting measured via the time-selection measure (adjusted mean difference=5.89, 95% CI 1.99-9.79), but not the monetary-selection scale (adjusted mean difference=–0.62, 95% CI –3.57 to 2.32), was associated with more past-hour tobacco use endorsement in follow-up surveys. Conclusions: This study evaluated a novel EMA-based scale’s ability to validly and reliably assess delay discounting. By measuring delay discounting with fewer items and in situ via EMA in natural environments, researchers may be better able to identify individuals at risk for poor health outcomes. %M 38412027 %R 10.2196/48954 %U https://formative.jmir.org/2024/1/e48954 %U https://doi.org/10.2196/48954 %U http://www.ncbi.nlm.nih.gov/pubmed/38412027 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e43999 %T Determinants of Implementing an Information and Communication Technology Tool for Social Interaction Among Older People: Qualitative Content Analysis of Social Services Personnel Perspectives %A Fritz,Johanna %A von Heideken Wågert,Petra %A Gusdal,Annelie K %A Johansson-Pajala,Rose-Marie %A Eklund,Caroline %+ School of Health, Care and Social Welfare, Mälardalen University, Box 883, Eskilstuna/Västerås, 721 23, Sweden, 46 21101503, johanna.fritz@mdu.se %K information and communication technology %K implementation %K determinants %K social isolation %K loneliness %K organization %K digitalization %K facilitators %K barriers %K older people %D 2024 %7 26.2.2024 %9 Original Paper %J JMIR Aging %G English %X Background: Older people are particularly vulnerable to social isolation and loneliness, which can lead to ill-health, both mentally and physically. Information and communication technology (ICT) can supplement health and social care and improve health among the vulnerable, older adult population. When ICT is used specifically for communication with others, it is associated with reduced loneliness in older populations. Research is sparse on how the implementation of ICT, used specifically for communication among older people in social services, can be performed. It is recommended to consider the determinants of implementation, that is, barriers to and facilitators of implementation. Determinants related to older people using ICT tools are reported in several studies. To the best of our knowledge, studies investigating the determinants related to the social services perspective are lacking. Objective: This study aims to explore the determinants of implementing the Fik@ room, a new, co-designed, and research-based ICT tool for social interaction among older people, from a social services personnel perspective. Methods: This study used an exploratory, qualitative design. An ICT tool called the Fik@ room was tested in an intervention study conducted in 2021 in 2 medium-sized municipalities in Sweden. Informants in this study were municipal social services personnel with experience of implementing this specific ICT tool in social services. We conducted a participatory workshop consisting of 2 parts, with 9 informants divided into 2 groups. We analyzed the data using qualitative content analysis with an inductive approach. Results: The results included 7 categories of determinants for implementing the ICT tool. Being able to introduce the ICT tool in an appropriate manner concerns the personnel’s options for introducing and supporting the ICT tool, including their competencies in using digital equipment. Organizational structure concerns a structure for communication within the organization. Leadership concerns engagement and enthusiasm as driving forces for implementation. The digital maturity of the social services personnel concerns the personnel’s skills and attitudes toward using digital equipment. Resources concern time and money. IT support concerns accessibility, and legal liability concerns possibilities to fulfill legal responsibilities. Conclusions: The results show that implementation involves an entire organization at varying degrees. Regardless of how much each level within the organization comes into direct contact with the ICT tool, all levels need to be involved to create the necessary conditions for successful implementation. The prerequisites for the implementation of an ICT tool will probably change depending on the digital maturity of future generations. As this study only included 9 informants, the results should be handled with care. The study was performed during the COVID-19 pandemic, which has probably affected the results. %M 38407955 %R 10.2196/43999 %U https://aging.jmir.org/2024/1/e43999 %U https://doi.org/10.2196/43999 %U http://www.ncbi.nlm.nih.gov/pubmed/38407955 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e47667 %T Building Pandemic-Resilient Primary Care Systems: Lessons Learned From COVID-19 %A Jeong,Yejin %A Crowell,Trevor %A Devon-Sand,Anna %A Sakata,Theadora %A Sattler,Amelia %A Shah,Shreya %A Tsai,Timothy %A Lin,Steven %+ Division of Primary Care and Population Health, Department of Medicine, Stanford University School of Medicine, 585 Broadway, Suite 800, Redwood City, CA, 94063, United States, 1 4086889720, timothy.tsai@stanford.edu %K barrier %K COVID-19 %K digital health %K implementation %K internet-based care %K pandemic %K primary care %K resilience %K resilient system %K telehealth %K telemedicine %D 2024 %7 23.2.2024 %9 Viewpoint %J J Med Internet Res %G English %X On January 30, 2023, the Biden Administration announced its intention to end the existing COVID-19 public health emergency declaration. The transition to a “postpandemic” landscape presents a unique opportunity to sustain and strengthen pandemic-era changes in care delivery. With this in mind, we present 3 critical lessons learned from a primary care perspective during the COVID-19 pandemic. First, clinical workflows must support both in-person and internet-based care delivery. Second, the integration of asynchronous care delivery is critical. Third, planning for the future means planning for everyone, including those with potentially limited access to health care due to barriers in technology and communication. While these lessons are neither unique to primary care settings nor all-encompassing, they establish a grounded foundation on which to construct higher-quality, more resilient, and more equitable health systems. %M 38393776 %R 10.2196/47667 %U https://www.jmir.org/2024/1/e47667 %U https://doi.org/10.2196/47667 %U http://www.ncbi.nlm.nih.gov/pubmed/38393776 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53514 %T Efficacy of StepAdd, a Personalized mHealth Intervention Based on Social Cognitive Theory to Increase Physical Activity Among Patients With Type 2 Diabetes Mellitus: Protocol for a Randomized Controlled Trial %A Waki,Kayo %A Tsurutani,Yuya %A Waki,Hironori %A Enomoto,Syunpei %A Kashiwabara,Kosuke %A Fujiwara,Akira %A Orime,Kazuki %A Kinguchi,Sho %A Yamauchi,Toshimasa %A Hirawa,Nobuhito %A Tamura,Kouichi %A Terauchi,Yasuo %A Nangaku,Masaomi %A Ohe,Kazuhiko %+ Department of Biomedical Informatics, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan, 81 03 5800 9129, kwaki-tky@m.u-tokyo.ac.jp %K digital therapeutics %K behavior change %K social cognitive theory %K exercise %K type 2 diabetes mellitus %K mobile app %K randomized controlled trial %K mobile phone %D 2024 %7 23.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Increasing physical activity improves glycemic control in patients with type 2 diabetes (T2D). Mobile health (mHealth) interventions have been proven to increase exercise, but engagement often fades with time. As the use of health behavior theory in mHealth design can increase effectiveness, we developed StepAdd, an mHealth intervention based on the constructs of social cognitive theory (SCT). StepAdd improves exercise behavior self-efficacy and self-regulation through the use of goal-setting, barrier-identifying, and barrier-coping strategies, as well as automatic feedback functions. A single-arm pilot study of StepAdd among 33 patients with T2D showed a large increase in step count (mean change of 4714, SD 3638 daily steps or +86.7%), along with strong improvements in BMI (mean change of −0.3 kg/m2) and hemoglobin A1c level (mean change of −0.79 percentage points). Objective: In this study, we aim to investigate the efficacy and safety of StepAdd, an mHealth exercise support system for patients with T2D, via a large, long, and controlled follow-up to the pilot study. Methods: This is a randomized, open-label, multicenter study targeting 160 patients with T2D from 5 institutions in Japan with a 24-week intervention. The intervention group will record daily step counts, body weight, and blood pressure using the SCT-based mobile app, StepAdd, and receive feedback about these measurements. In addition, they will set weekly step count goals, identify personal barriers to walking, and define strategies to overcome these barriers. The control group will record daily step counts, body weight, and blood pressure using a non–SCT-based placebo app. Both groups will receive monthly consultations with a physician who will advise patients regarding lifestyle modifications and use of the app. The 24-week intervention period will be followed by a 12-week observational period to investigate the sustainability of the intervention’s effects. The primary outcome is between-group difference in the change in hemoglobin A1c values at 24 weeks. The secondary outcomes include other health measures, measurements of steps, measurements of other behavior changes, and assessments of app use. The trial began in January 2023 and is intended to be completed in December 2025. Results: As of September 5, 2023, we had recruited 44 patients. We expect the trial to be completed by October 8, 2025, with the follow-up observation period being completed by December 31, 2025. Conclusions: This trial will provide important evidence about the efficacy of an SCT-based mHealth intervention in improving physical activities and glycemic control in patients with T2D. If this study proves the intervention to be effective and safe, it could be a key step toward the integration of mHealth as part of the standard treatment received by patients with T2D in Japan. Trial Registration: Japan Registry of Clinical Trials (JRCT) jRCT2032220603; https://rctportal.niph.go.jp/en/detail?trial_id=jRCT2032220603 International Registered Report Identifier (IRRID): DERR1-10.2196/53514 %M 38393770 %R 10.2196/53514 %U https://www.researchprotocols.org/2024/1/e53514 %U https://doi.org/10.2196/53514 %U http://www.ncbi.nlm.nih.gov/pubmed/38393770 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e49110 %T Co-Production of a Flexibly Delivered Relapse Prevention Tool to Support the Self-Management of Long-Term Mental Health Conditions: Co-Design and User Testing Study %A Milton,Alyssa %A Ozols A M,Ingrid %A Cassidy,Tayla %A Jordan,Dana %A Brown,Ellie %A Arnautovska,Urska %A Cook,Jim %A Phung,Darren %A Lloyd-Evans,Brynmor %A Johnson,Sonia %A Hickie,Ian %A Glozier,Nick %+ Faculty of Medicine and Health, The University of Sydney, Level 5 Professor Marie Bashir Centre, 67-73 Missenden Rd, Camperdown, 2050, Australia, 61 02 9515 1461, alyssa.milton@sydney.edu.au %K self-management %K serious mental illness %K self-care %K digital health tools %K blended interventions %K peer support %K mobile phone %D 2024 %7 23.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Supported self-management interventions, which assist individuals in actively understanding and managing their own health conditions, have a robust evidence base for chronic physical illnesses, such as diabetes, but have been underused for long-term mental health conditions. Objective: This study aims to co-design and user test a mental health supported self-management intervention, My Personal Recovery Plan (MyPREP), that could be flexibly delivered via digital and traditional paper-based mediums. Methods: This study adopted a participatory design, user testing, and rapid prototyping methodologies, guided by 2 frameworks: the 2021 Medical Research Council framework for complex interventions and an Australian co-production framework. Participants were aged ≥18 years, self-identified as having a lived experience of using mental health services or working in a peer support role, and possessed English proficiency. The co-design and user testing processes involved a first round with 6 participants, focusing on adapting a self-management resource used in a large-scale randomized controlled trial in the United Kingdom, followed by a second round with 4 new participants for user testing the co-designed digital version. A final round for gathering qualitative feedback from 6 peer support workers was conducted. Data analysis involved transcription, coding, and thematic interpretation as well as the calculation of usability scores using the System Usability Scale. Results: The key themes identified during the co-design and user testing sessions were related to (1) the need for self-management tools to be flexible and well-integrated into mental health services, (2) the importance of language and how language preferences vary among individuals, (3) the need for self-management interventions to have the option of being supported when delivered in services, and (4) the potential of digitization to allow for a greater customization of self-management tools and the development of features based on individuals’ unique preferences and needs. The MyPREP paper version received a total usability score of 71, indicating C+ or good usability, whereas the digital version received a total usability score of 85.63, indicating A or excellent usability. Conclusions: There are international calls for mental health services to promote a culture of self-management, with supported self-management interventions being routinely offered. The resulting co-designed prototype of the Australian version of the self-management intervention MyPREP provides an avenue for supporting self-management in practice in a flexible manner. Involving end users, such as consumers and peer workers, from the beginning is vital to address their need for personalized and customized interventions and their choice in how interventions are delivered. Further implementation-effectiveness piloting of MyPREP in real-world mental health service settings is a critical next step. %M 38393768 %R 10.2196/49110 %U https://formative.jmir.org/2024/1/e49110 %U https://doi.org/10.2196/49110 %U http://www.ncbi.nlm.nih.gov/pubmed/38393768 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e48881 %T Perception of Apps for Mental Health Assessment With Recommendations for Future Design: United Kingdom Semistructured Interview Study %A Funnell,Erin L %A Spadaro,Benedetta %A Martin-Key,Nayra A %A Benacek,Jiri %A Bahn,Sabine %+ Cambridge Centre for Neuropsychiatric Research, Department of Chemical Engineering, University of Cambridge, Philippa Fawcett Drive, Cambridge, CB3 0AS, United Kingdom, 44 1223 334151, sb209@cam.ac.uk %K app design %K digital health %K eHealth %K interviews %K mental health %K mHealth %K mobile phone %D 2024 %7 23.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Mental health care provision in the United Kingdom is overwhelmed by a high demand for services. There are high rates of under-, over-, and misdiagnosis of common mental health disorders in primary care and delays in accessing secondary care. This negatively affects patient functioning and outcomes. Digital tools may offer a time-efficient avenue for the remote assessment and triage of mental health disorders that can be integrated directly into existing care pathways to support clinicians. However, despite the potential of digital tools in the field of mental health, there remain gaps in our understanding of how the intended user base, people with lived experiences of mental health concerns, perceive these technologies. Objective: This study explores the perspectives and attitudes of individuals with lived experiences of mental health concerns on mental health apps that are designed to support self-assessment and triage. Methods: A semistructured interview approach was used to explore the perspectives of the interviewees using 5 open-ended questions. Interviews were transcribed verbatim from audio data recordings. The average interview lasted 46 minutes (rounded to the nearest min; SD 12.93 min). A thematic analysis was conducted. Results: Overall, 16 individuals were interviewed in this study. The average age was 42.25 (SD 15.18) years, half of the interviewees identified as women (8/16, 50%), and all were White (16/16, 100%). The thematic analysis revealed six major themes: (1) availability and accessibility, (2) quality, (3) attitudes, (4) safety, (5) impact, and (6) functionality. Conclusions: Engaging in clear communication regarding data security and privacy policies, adopting a consent-driven approach to data sharing, and identifying gaps in the app marketplace to foster the inclusion of a range of mental health conditions and avoid oversaturation of apps for common mental health disorders (eg, depression and anxiety) were identified as priorities from interviewees’ comments. Furthermore, reputation was identified as a driver of uptake and engagement, with endorsement from a respected source (ie, health care provider, academic institution) or direct recommendation from a trusted health care professional associated with increased interest and trust. Furthermore, there was an interest in the role that co-designed digital self-assessments could play in existing care pathways, particularly in terms of facilitating informed discussions with health care professionals during appointments and by signposting individuals to the most appropriate services. In addition, interviewees discussed the potential of mental health apps to provide waiting list support to individuals awaiting treatment by providing personalized psychoeducation, self-help tips, and sources of help. However, concerns regarding the quality of care being affected because of digital delivery have been reported; therefore, frequent monitoring of patient acceptability and care outcomes is warranted. In addition, communicating the rationale and benefits of digitizing services will likely be important for securing interest and uptake from health care service users. %M 38393760 %R 10.2196/48881 %U https://formative.jmir.org/2024/1/e48881 %U https://doi.org/10.2196/48881 %U http://www.ncbi.nlm.nih.gov/pubmed/38393760 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e47809 %T Digital Care Pathway for Patients With Sleep Apnea in Specialized Care: Mixed Methods Study %A Haverinen,Jari %A Harju,Terttu %A Mikkonen,Hanna %A Liljamo,Pia %A Turpeinen,Miia %A Reponen,Jarmo %+ Finnish Coordinating Center for Health Technology Assessment, Oulu University Hospital, Kajaanintie 50, Oulu, PL10, Finland, 358 504095446, jari.haverinen@pohde.fi %K health services %K telehealth %K telemedicine %K health personnel %K sleep apnea syndromes %K mobile phone %D 2024 %7 22.2.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Sleep apnea is a significant public health disorder in Finland, with a prevalence of 3.7%. Continuous positive airway pressure (CPAP) therapy is the first-line treatment for moderate or severe sleep apnea. From November 18, 2019, all patients who started their CPAP therapy at Oulu University Hospital were attached to a sleep apnea digital care pathway (SA-DCP) and were instructed on its use. Some patients still did not use the SA-DCP although they had started their CPAP therapy. Objective: We aimed to study health care professionals’ (HCPs’) perspectives on the SA-DCP and its usefulness for their work; whether the main targets of SA-DCP can be reached: shortening the initial guiding sessions of CPAP therapy, reducing patient calls and contact with HCPs, and improving patients’ adherence to CPAP therapy; and patients’ perspectives on the SA-DCP and its usefulness to them. Methods: Overall, 6 HCPs were interviewed in May and June 2021. The survey for SA-DCP users (58/91, 64%) and SA-DCP nonusers (33/91, 36%) was conducted in 2 phases: from May to August 2021 and January to June 2022. CPAP device remote monitoring data were collected from SA-DCP users (80/170, 47.1%) and SA-DCP nonusers (90/170, 52.9%) in May 2021. The registered phone call data were collected during 2019, 2020, and 2021. Feedback on the SA-DCP was collected from 446 patients between February and March 2022. Results: According to HCPs, introducing the SA-DCP had not yet significantly improved their workload and work practices, but it had brought more flexibility in some communication situations. A larger proportion of SA-DCP users familiarized themselves with prior information about CPAP therapy before the initial guiding session than nonusers (43/58, 74% vs 16/33, 49%; P=.02). Some patients still had not received prior information about CPAP therapy; therefore, most of the sessions were carried out according to their needs. According to the patient survey and remote monitoring data of CPAP devices, adherence to CPAP therapy was high for both SA-DCP users and nonusers. The number of patients’ phone calls to HCPs did not decrease during the study. SA-DCP users perceived their abilities to use information and communications technology to be better than nonusers (mean 4.2, SD 0.8 vs mean 3.2, SD 1.2; P<.001). Conclusions: According to this study, not all the goals set for the introduction of the SA-DCP have been achieved. Despite using the SA-DCP, some patients still wanted to communicate with HCPs by phone. The most significant factors explaining the nonuse of the SA-DCP were lower digital literacy and older age of the patients. In the future, more attention should be paid to these user groups when designing and introducing upcoming digital care pathways. %M 38386368 %R 10.2196/47809 %U https://humanfactors.jmir.org/2024/1/e47809 %U https://doi.org/10.2196/47809 %U http://www.ncbi.nlm.nih.gov/pubmed/38386368 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 10 %N %P e46625 %T Improving Concordance Between Clinicians With Australian Guidelines for Bowel Cancer Prevention Using a Digital Application: Randomized Controlled Crossover Study %A Ow,Tsai-Wing %A Sukocheva,Olga %A Bampton,Peter %A Iyngkaran,Guruparan %A Rayner,Christopher K %A Tse,Edmund %+ Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Port Road, Adelaide, 5000, Australia, 61 70740000, tsai-wing.ow@sa.gov.au %+ Faculty of Health and Medical Sciences, University of Adelaide, North Terrace, Adelaide, 5005, Australia, 61 83135208, tsai-wing.ow@sa.gov.au %K colorectal cancer %K guidelines %K colorectal cancer screening %K digital application %K questionnaire %K application %K cancer prevention %K prevention %K cancer %K bowel cancer %K surveillance %K clinical vignette quiz %K usability %K Australia %D 2024 %7 22.2.2024 %9 Original Paper %J JMIR Cancer %G English %X Background: Australia’s bowel cancer prevention guidelines, following a recent revision, are among the most complex in the world. Detailed decision tables outline screening or surveillance recommendations for 230 case scenarios alongside cessation recommendations for older patients. While these guidelines can help better allocate limited colonoscopy resources, their increasing complexity may limit their adoption and potential benefits. Therefore, tools to support clinicians in navigating these guidelines could be essential for national bowel cancer prevention efforts. Digital applications (DAs) represent a potentially inexpensive and scalable solution but are yet to be tested for this purpose. Objective: This study aims to assess whether a DA could increase clinician adherence to Australia’s new colorectal cancer screening and surveillance guidelines and determine whether improved usability correlates with greater conformance to guidelines. Methods: As part of a randomized controlled crossover study, we created a clinical vignette quiz to evaluate the efficacy of a DA in comparison with the standard resource (SR) for making screening and surveillance decisions. Briefings were provided to study participants, which were tailored to their level of familiarity with the guidelines. We measured the adherence of clinicians according to their number of guideline-concordant responses to the scenarios in the quiz using either the DA or the SR. The maximum score was 18, with higher scores indicating improved adherence. We also tested the DA’s usability using the System Usability Scale. Results: Of 117 participants, 80 were included in the final analysis. Using the SR, the adherence of participants was rated a median (IQR) score of 10 (7.75-13) out of 18. The participants’ adherence improved by 40% (relative risk 1.4, P<.001) when using the DA, reaching a median (IQR) score of 14 (12-17) out of 18. The DA was rated highly for usability with a median (IQR) score of 90 (72.5-95) and ranked in the 96th percentile of systems. There was a moderate correlation between the usability of the DA and better adherence (rs=0.4; P<.001). No differences between the adherence of specialists and nonspecialists were found, either with the SR (10 vs 9; P=.47) or with the DA (13 vs 15; P=.24). There was no significant association between participants who were less adherent with the DA (n=17) and their age (P=.06), experience with decision support tools (P=.51), or academic involvement with a university (P=.39). Conclusions: DAs can significantly improve the adoption of complex Australian bowel cancer prevention guidelines. As screening and surveillance guidelines become increasingly complex and personalized, these tools will be crucial to help clinicians accurately determine the most appropriate recommendations for their patients. Additional research to understand why some practitioners perform worse with DAs is required. Further improvements in application usability may optimize guideline concordance further. %M 38238256 %R 10.2196/46625 %U https://cancer.jmir.org/2024/1/e46625 %U https://doi.org/10.2196/46625 %U http://www.ncbi.nlm.nih.gov/pubmed/38238256 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e49952 %T A Risk Assessment and Planning Tool to Prevent Sudden Unexpected Death in Infancy: Development and Evaluation of The Baby Sleep Planner %A Pease,Anna %A Ingram,Jenny %A Lambert,Becky %A Patrick,Karen %A Pitts,Kieren %A Fleming,Peter J %A Blair,Peter S %A , %+ Population Health Sciences, Bristol Medical School, University of Bristol, 3.02 Canynge Hall, 39 Whatley Road, Bristol, BS82PS, United Kingdom, 44 117 455 625, a.pease@bristol.ac.uk %K safer sleep %K parent education %K co-design %K process evaluation %K sudden infant death syndrome %K SIDS %K sleep %K baby %K babies %K infant %K infants %K prototype %K interface %K develop %K development %K sleeping %K pattern %K tool %K parent %K infant mortality %K risk %K risks %K assessment %K death %K mortality %K parents %K parenting %K risk assessment %K sudden unexpected death in infancy %K SUDI %K approach %K antenatal %K postnatal %K user testing %K user experience %K web-based %K experience %K experiences %K attitude %K attitudes %K opinion %K perception %K perceptions %K perspective %K perspectives %D 2024 %7 22.2.2024 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Successful national safer sleep campaigns in the United Kingdom have lowered the death rates from sudden unexpected death in infancy (SUDI) over the past 3 decades, but deaths persist in socioeconomically deprived families. The circumstances of current deaths suggest that improvements in support for some families to follow safer sleep advice more consistently could save lives. Objective: This study aimed to develop and evaluate a risk assessment and planning tool designed to improve the uptake of safer sleep advice in families with infants at increased risk of SUDI. Methods: A co-design approach was used to develop the prototype interface of a web-based tool with 2 parts: an individual SUDI risk assessment at birth and a downloadable plan for safety during times of disruption. The advice contained within the tool is concordant with national guidance from the Lullaby Trust, the United Nations International Children’s Emergency Fund (UNICEF), and the National Institute for Health and Care Excellence. User testing of the prototype tool was conducted by inviting health visitors, midwives, and family nurses to use it with families eligible for additional support. Qualitative interviews with health professionals and families allowed for iterative changes to the tool and for insights into its function and influence on parental behavior. Results: A total of 22 health professionals were enrolled in the study, of whom 20 (91%) were interviewed. They reported appreciating the functionality of the tool, which allowed them to identify at-risk families for further support. They felt that the tool improved how they communicated about risks with families. They suggested expanding its use to include relevance in the antenatal period and having versions available in languages other than English. They reported using the tool with 58 families; 20 parents gave consent to be interviewed by the research team about their experiences with the tool. Families were positive about the tool, appreciated the trustworthy information, and felt that it was useful and appropriate and that the plans for specific infant sleeps would be of benefit to them and other family members. Conclusions: Our tool combines risk assessment and safety planning, both of which have the potential to improve the uptake of lifesaving advice. Refinements to the tool based on these findings have ensured that the tool is ready for further evaluation in a larger study before being rolled out to families with infants at increased risk. %M 38386377 %R 10.2196/49952 %U https://pediatrics.jmir.org/2024/1/e49952 %U https://doi.org/10.2196/49952 %U http://www.ncbi.nlm.nih.gov/pubmed/38386377 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e52905 %T Effects of eHealth Interventions on 24-Hour Movement Behaviors Among Preschoolers: Systematic Review and Meta-Analysis %A Jiang,Shan %A Ng,Johan Y Y %A Chong,Kar Hau %A Peng,Bo %A Ha,Amy S %+ Department of Sports Science and Physical Education, The Chinese University of Hong Kong, G05 Kwok Sports Building, Shatin, N.T., Hong Kong, China (Hong Kong), 852 3943 6083, sauchingha@cuhk.edu.hk %K preschooler %K movement behaviors %K eHealth %K physical activity %K sedentary behavior %K sleep %K mobile phone %K review %K systematic review %D 2024 %7 21.2.2024 %9 Review %J J Med Internet Res %G English %X Background: The high prevalence of unhealthy movement behaviors among young children remains a global public health issue. eHealth is considered a cost-effective approach that holds great promise for enhancing health and related behaviors. However, previous research on eHealth interventions aimed at promoting behavior change has primarily focused on adolescents and adults, leaving a limited body of evidence specifically pertaining to preschoolers. Objective: This review aims to examine the effectiveness of eHealth interventions in promoting 24-hour movement behaviors, specifically focusing on improving physical activity (PA) and sleep duration and reducing sedentary behavior among preschoolers. In addition, we assessed the moderating effects of various study characteristics on intervention effectiveness. Methods: We searched 6 electronic databases (PubMed, Ovid, SPORTDiscus, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials) for experimental studies with a randomization procedure that examined the effectiveness of eHealth interventions on 24-hour movement behaviors among preschoolers aged 2 to 6 years in February 2023. The study outcomes included PA, sleep duration, and sedentary time. A meta-analysis was conducted to assess the pooled effect using a random-effects model, and subgroup analyses were conducted to explore the potential effects of moderating factors such as intervention duration, intervention type, and risk of bias (ROB). The included studies underwent a rigorous ROB assessment using the Cochrane ROB tool. Moreover, the certainty of evidence was evaluated using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) assessment. Results: Of the 7191 identified records, 19 (0.26%) were included in the systematic review. The meta-analysis comprised a sample of 2971 preschoolers, which was derived from 13 included studies. Compared with the control group, eHealth interventions significantly increased moderate to vigorous PA (Hedges g=0.16, 95% CI 0.03-0.30; P=.02) and total PA (Hedges g=0.37, 95% CI 0.02-0.72; P=.04). In addition, eHealth interventions significantly reduced sedentary time (Hedges g=−0.15, 95% CI −0.27 to −0.02; P=.02) and increased sleep duration (Hedges g=0.47, 95% CI 0.18-0.75; P=.002) immediately after the intervention. However, no significant moderating effects were observed for any of the variables assessed (P>.05). The quality of evidence was rated as “moderate” for moderate to vigorous intensity PA and sedentary time outcomes and “low” for sleep outcomes. Conclusions: eHealth interventions may be a promising strategy to increase PA, improve sleep, and reduce sedentary time among preschoolers. To effectively promote healthy behaviors in early childhood, it is imperative for future studies to prioritize the development of rigorous comparative trials with larger sample sizes. In addition, researchers should thoroughly examine the effects of potential moderators. There is also a pressing need to comprehensively explore the long-term effects resulting from these interventions. Trial Registration: PROSPERO CRD42022365003; http://tinyurl.com/3nnfdwh3 %M 38381514 %R 10.2196/52905 %U https://www.jmir.org/2024/1/e52905 %U https://doi.org/10.2196/52905 %U http://www.ncbi.nlm.nih.gov/pubmed/38381514 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e42322 %T Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Dental or Injection Phobia: Randomized Controlled Trial %A Schibbye,Robert %A Hedman-Lagerlöf,Erik %A Kaldo,Viktor %A Dahllöf,Göran %A Shahnavaz,Shervin %+ Department of Dental Medicine, Karolinska Institutet, Box 4064, Huddinge, 141 04, Sweden, 46 8 524 800 0, robert.schibbye@ki.se %K adolescents %K cognitive behavioral therapy %K CBT %K children %K dental anxiety %K dental fear %K internet %K specific phobia %D 2024 %7 21.2.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Dental phobia (DP) and injection phobia (IP) are common in children and adolescents and are considered some of the biggest obstacles to successful treatment in pediatric dentistry. Cognitive behavioral therapy (CBT) is an evidence-based treatment for anxiety and phobias. As the availability of CBT in dentistry is low, internet-based CBT (ICBT) was developed. Open trials have shown that ICBT is a promising intervention, but randomized trials are lacking. Objective: This randomized controlled trial tests whether therapist-guided ICBT supported by a parent could reduce fear, allowing children and adolescents with DP or IP to receive dental treatment. Methods: We enrolled 33 participants (mean age 11.2, SD 1.9 y) whom a clinical psychologist had diagnosed with DP, IP, or both. After inclusion, participants were randomized to either ICBT (17/33, 52%) or a control group of children on a waitlist (16/33, 48%). ICBT was based on exposure therapy and comprised a 12-week at-home program combined with visits to their regular dental clinic. Participants corresponded weekly with their therapist after completing each module, and 1 parent was designated as a coach to support the child in the assignments during treatment. All participants completed measurements of the outcome variables before treatment start and after 12 weeks (at treatment completion). The measurements included a structured diagnostic interview with a clinical psychologist. Our primary outcome measure was the Picture-Guided Behavioral Avoidance Test (PG-BAT), which assesses the ability to approach 17 dental clinical procedures, and a positive clinical diagnosis. Secondary outcome measures included self-report questionnaires that measured self-efficacy and levels of dental and injection anxiety. The children and their parents completed the questionnaires. Results: All participants underwent the 12-week follow-up. After treatment, 41% (7/17) of the participants in the ICBT group no longer met the diagnostic criteria for DP or IP, whereas all participants in the control group did (P=.004). Repeated-measure ANOVAs showed that ICBT led to greater improvements on the PG-BAT compared with the control group; between-group effect sizes for the Cohen d were 1.6 (P<.001) for the child-rated PG-BAT and 1.0 (P=.009) for the parent-rated PG-BAT. Reductions in our secondary outcomes—dental fear and anxiety (P<.001), negative cognitions (P=.001), and injection fear (P=.011)—as well as improvements in self-efficacy (P<.001), were all significantly greater among children in the ICBT group than in the controls. No participants reported adverse events. Conclusions: ICBT seems to be an effective treatment for DP and IP in children and adolescents. It reduced fear and anxiety and enabled participants to willingly receive dental treatment. ICBT should be seriously considered in clinical practice to increase accessibility; this therapy may reduce the need for sedation and restraint and lead to better dental health in children and adolescents. Trial Registration: ClinicalTrials.gov NCT02588079; https://clinicaltrials.gov/study/NCT02588079 %M 38381476 %R 10.2196/42322 %U https://www.jmir.org/2024/1/e42322 %U https://doi.org/10.2196/42322 %U http://www.ncbi.nlm.nih.gov/pubmed/38381476 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e41649 %T Effectiveness of eHealth Interventions Promoting Physical Activity in Children and Adolescents: Systematic Review and Meta-Analysis %A Sequí-Domínguez,Irene %A Cavero-Redondo,Iván %A Álvarez-Bueno,Celia %A López-Gil,Jose Francisco %A Martínez-Vizcaíno,Vicente %A Pascual-Morena,Carlos %+ Health and Social Research Center, Universidad de Castilla-La Mancha, Edificio Melchor Cano, Centro de Estudios Socio-Sanitarios,, Santa Teresa Jornet s/n,, Cuenca, 16071, Spain, 34 969179100, vicente.martinez@uclm.es %K eHealth technologies %K physical activity %K sedentary behaviors %K children %K mobile phone %D 2024 %7 21.2.2024 %9 Review %J J Med Internet Res %G English %X Background: eHealth interventions have been postulated as a feasible, acceptable, and possibly effective tool to promote physical activity (PA) among children and adolescents; however, a comprehensive quantitative analysis of the effects of eHealth interventions promoting PA is lacking. Objective: This study aims to conduct a systematic review and meta-analysis on experimental studies reporting the effects of eHealth interventions aimed at promoting PA on PA parameters and sedentary behavior parameters in children and adolescents. Methods: The CENTRAL, MEDLINE, Embase, and Web of Science databases were searched from inception to February 2022 for randomized controlled trials that analyzed the effects of eHealth interventions aimed at promoting PA on PA and sedentary parameters in children and adolescents. The Hartung-Knapp-Sidik-Jonkman random effects method was used to determine the mean differences (MDs) with their respective 95% CIs. The risk of bias was assessed using the Risk of Bias 2 (RoB2; Cochrane) tool and its extension for cluster randomized controlled trials. The certainty of evidence was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) tool. Results: A total of 20 trials reporting the effects of different eHealth interventions aimed at promoting PA were included. Results for each parameter were as follows: counts per minute (MD −16.11 counts, 95% CI −122.76 to 90.53; k=3; n=402; I2=69%; favoring control), steps per day (MD 593.46 steps, 95% CI −2102.27 to 3289.19; k=2; n=152; I2=0%; favoring intervention [FI]), moderate to vigorous PA (MD −1.99 min/d, 95% CI −8.95 to 4.96; k=14; n=2336; I2=86%; favoring control), light PA (MD 3.28 min/d, 95% CI −15.48 to 22.04; k=5; n=355; I2=67%; FI), screen time (MD −31.48 min/d, 95% CI −68.62 to 5.65; k=5; n=904; I2=0%; FI), and sedentary time (MD −33.12 min/d, 95% CI −57.27 to −8.97; k=8; n=819; I2=75%; FI). Our results should be interpreted cautiously because of important limitations such as the scarcity of evidence, overall risk of bias, and low to very low certainty of evidence. Conclusions: We did not find conclusive evidence regarding the impact of PA-targeted eHealth interventions on PA parameters, but the very low certainty of evidence suggests that eHealth interventions may reduce sedentary time in children and adolescents. Our results may have important scientific implications as they highlight that the rapid development of eHealth interventions to promote PA lacks robust supporting evidence. Trial Registration: PROSPERO CRD42020211020; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=211020 %M 38381490 %R 10.2196/41649 %U https://www.jmir.org/2024/1/e41649 %U https://doi.org/10.2196/41649 %U http://www.ncbi.nlm.nih.gov/pubmed/38381490 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e52338 %T Group, Blended and Individual, Unguided Online Delivery of Mindfulness-Based Cognitive Therapy for People With Cancer: Feasibility Uncontrolled Trial %A Badaghi,Nasim %A van Kruijsbergen,Mette %A Speckens,Anne %A Vilé,Joëlle %A Prins,Judith %A Kelders,Saskia %A Kwakkenbos,Linda %+ Department of Psychiatry, Radboud University Medical Center, Geert Grooteplein Zuid 10, Nijmegen, 6525 GA, Netherlands, 31 0624835397, nasim.badaghimoreno@radboudumc.nl %K cancer %K eHeath %K online interventions %K mindfulness %K psycho-oncology %K qualitative research %K oncology %K CBT %K blended %K eMBCT %K iCBT %K cognitive therapy %K unguided %K psychotherapy %K MBCT %K co-creation %K therapist %K self-guided %K peer-support %K co-design %K participatory %D 2024 %7 21.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Online mindfulness based cognitive therapy (eMBCT) has been shown to reduce psychological distress in people with cancer. However, this population has reported lack of support and asynchronous communication as barriers to eMBCT, resulting in higher nonadherence rates than with face-to-face MBCT. Using a co-creation process, we developed 2 formats of eMBCT: group, blended (combination of therapist-guided group and individual online sessions) and individual, unguided (individual, unguided online sessions only). Group, blended eMBCT offers peer support and guidance, whereas individual, unguided eMBCT offers flexibility and the possibility of large-scale implementation. Objective: The objective of this nonrandomized feasibility study was to assess aspects of feasibility of the group, blended and individual, unguided eMBCT interventions. Methods: Participants were people with cancer who chose between group, blended and individual, unguided eMBCT. Both intervention conditions followed the same 8-week eMBCT program, including an introductory session and a silent day (10 sessions total). All sessions for individual, unguided eMBCT occurred via the platform Minddistrict, whereas group, blended eMBCT consisted of 3 online videoconference sessions guided by a mindfulness teacher and 5 sessions via Minddistrict. We assessed the feasibility of the intervention quantitatively and qualitatively by evaluating its acceptability among participants. Additionally, we assessed limited efficacy by looking at the number of questionnaires participants completed pre- and postintervention. Results: We included 12 participants for each eMBCT condition. Participants in group, blended eMBCT completed, on average, 9.7 of 10 sessions, compared with an average 8.3 sessions for individual, unguided eMBCT (excluding dropouts). Of the 24 participants, 13 (54%) agreed to be interviewed (5 unguided and 8 blended). Participants in both conditions reported positive experiences, including the convenience of not having to travel and the flexibility to choose when and where to participate. However, among the barriers for participation, participants in the group, blended condition reported a preference for more group sessions, and participants in the individual, unguided condition reported a lack of guidance. Additionally, for the group, blended condition, the effect sizes were small for all outcome measures (Hedges g range=0.01-0.36), except for fatigue, which had a moderate effect size (Hedges g=0.57). For the individual, unguided condition, the effect sizes were small for all outcome measures (Hedges g range=0.24-0.46), except for mindfulness skills (Hedges g=0.52) and engagement with the intervention (Hedges g=1.53). Conclusions: Participants in this study had a positive experience with group, blended and individual, unguided eMBCT. Based on the results from this study, we will adjust the intervention prior to conducting a full-scale randomized controlled trial to evaluate effectiveness; we will add 1 group session to the group, blended eMBCT using Zoom as the platform for the group sessions; and we will send reminders to participants to complete questionnaires. Trial Registration: ClinicalTrials.gov NCT05336916; https://clinicaltrials.gov/ct2/show/NCT05336916 %M 38381493 %R 10.2196/52338 %U https://formative.jmir.org/2024/1/e52338 %U https://doi.org/10.2196/52338 %U http://www.ncbi.nlm.nih.gov/pubmed/38381493 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e48557 %T A Social Media–Based Mindfulness Psycho-Behavioral Intervention (MCARE) for Patients With Acute Coronary Syndrome: Randomized Controlled Trial %A Zou,Huijing %A Chair,Sek Ying %A Feng,Bilong %A Liu,Qian %A Liu,Yu Jia %A Cheng,Yu Xin %A Luo,Dan %A Wang,Xiao Qin %A Chen,Wei %A Huang,Leiqing %A Xianyu,Yunyan %A Yang,Bing Xiang %+ School of Nursing, Wuhan University, No. 115 Donghu Road, Wuchang District, Wuhan, 430071, China, 86 02768788685, yangbx@whu.edu.cn %K acute coronary syndrome %K psychological distress %K depression %K anxiety %K mindfulness %K mindfulness-based intervention %K quality of life %K risk factors %K cardiac rehabilitation %K social media %D 2024 %7 20.2.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Psychological distress is common among patients with acute coronary syndrome (ACS) and has considerable adverse impacts on disease progression and health outcomes. Mindfulness-based intervention is a promising complementary approach to address patients’ psychological needs and promote holistic well-being. Objective: This study aims to examine the effects of a social media–based mindfulness psycho-behavioral intervention (MCARE) on psychological distress, psychological stress, health-related quality of life (HRQoL), and cardiovascular risk factors among patients with ACS. Methods: This study was a 2-arm, parallel-group randomized controlled trial. We recruited 178 patients (mean age 58.7, SD 8.9 years; 122/178, 68.5% male) with ACS at 2 tertiary hospitals in Jinan, China. Participants were randomly assigned to the MCARE group (n=89) or control group (n=89). The 6-week intervention consisted of 1 face-to-face session (phase I) and 5 weekly WeChat (Tencent Holdings Ltd)–delivered sessions (phase II) on mindfulness training and health education and lifestyle modification. The primary outcomes were depression and anxiety. Secondary outcomes included psychological stress, HRQoL, and cardiovascular risk factors (ie, smoking status, physical activity, dietary behavior, BMI, blood pressure, blood lipids, and blood glucose). Outcomes were measured at baseline (T0), immediately after the intervention (T1), and 12 weeks after the commencement of the intervention (T2). Results: The MCARE group showed significantly greater reductions in depression (T1: β=–2.016, 95% CI –2.584 to –1.449, Cohen d=–1.28, P<.001; T2: β=–2.089, 95% CI –2.777 to –1.402, Cohen d=–1.12, P<.001) and anxiety (T1: β=–1.024, 95% CI –1.551 to –0.497, Cohen d=–0.83, P<.001; T2: β=–0.932, 95% CI –1.519 to –0.346, Cohen d=–0.70, P=.002). Significantly greater improvements were also observed in psychological stress (β=–1.186, 95% CI –1.678 to –0.694, Cohen d=–1.41, P<.001), physical HRQoL (β=0.088, 95% CI 0.008-0.167, Cohen d=0.72, P=.03), emotional HRQoL (β=0.294, 95% CI 0.169-0.419, Cohen d=0.81, P<.001), and general HRQoL (β=0.147, 95% CI 0.070-0.224, Cohen d=1.07) at T1, as well as dietary behavior (β=0.069, 95% CI 0.003-0.136, Cohen d=0.75, P=.04), physical activity level (β=177.542, 95% CI –39.073 to 316.011, Cohen d=0.51, P=.01), and systolic blood pressure (β=–3.326, 95% CI –5.928 to –0.725, Cohen d=–1.32, P=.01) at T2. The overall completion rate of the intervention (completing ≥5 sessions) was 76% (68/89). Positive responses to the questions of the acceptability questionnaire ranged from 93% (76/82) to 100% (82/82). Conclusions: The MCARE program generated favorable effects on psychological distress, psychological stress, HRQoL, and several aspects of cardiovascular risk factors in patients with ACS. This study provides clues for guiding clinical practice in the recognition and management of psychological distress and integrating the intervention into routine rehabilitation practice. Trial Registration: Chinese Clinical Trial Registry ChiCTR2000033526; https://www.chictr.org.cn/showprojEN.html?proj=54693 %M 38376899 %R 10.2196/48557 %U https://www.jmir.org/2024/1/e48557 %U https://doi.org/10.2196/48557 %U http://www.ncbi.nlm.nih.gov/pubmed/38376899 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e47040 %T Comparing the Effectiveness of the Blended Delivery Mode With the Face-to-Face Delivery Mode of Smoking Cessation Treatment: Noninferiority Randomized Controlled Trial %A Siemer,Lutz %A Pieterse,Marcel E %A Ben Allouch,Somaya %A Postel,Marloes G %A Brusse-Keizer,Marjolein G J %+ School of Social Work, Saxion University of Applied Sciences, M. H. Tromplaan 28, Enschede, 7513 AB, Netherlands, 31 657459469, l.siemer@saxion.nl %K tobacco %K blended treatment %K smoking cessation %K randomized controlled trial %K effectiveness %K noninferiority %K evaluation %K mobile phone %D 2024 %7 20.2.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Tobacco consumption is a leading cause of death and disease, killing >8 million people each year. Smoking cessation significantly reduces the risk of developing smoking-related diseases. Although combined treatment for addiction is promising, evidence of its effectiveness is still emerging. Currently, there is no published research comparing the effectiveness of blended smoking cessation treatments (BSCTs) with face-to-face (F2F) treatments, where web-based components replace 50% of the F2F components in blended treatment. Objective: The primary objective of this 2-arm noninferiority randomized controlled trial was to determine whether a BSCT is noninferior to an F2F treatment with identical ingredients in achieving abstinence rates. Methods: This study included 344 individuals who smoke (at least 1 cigarette per day) attending an outpatient smoking cessation clinic in the Netherlands. The participants received either a blended 50% F2F and 50% web-based BSCT or only F2F treatment with similar content and intensity. The primary outcome measure was cotinine-validated abstinence rates from all smoking products at 3 and 15 months after treatment initiation. Additional measures included carbon monoxide–validated point prevalence abstinence; self-reported point prevalence abstinence; and self-reported continuous abstinence rates at 3, 6, 9, and 15 months after treatment initiation. Results: None of the 13 outcomes showed statistically confirmed noninferiority of the BSCT, whereas 4 outcomes showed significantly (P<.001) inferior abstinence rates of the BSCT: cotinine-validated point prevalence abstinence rate at 3 months (difference 12.7, 95% CI 6.2-19.4), self-reported point prevalence abstinence rate at 6 months (difference 19.3, 95% CI 11.5-27.0) and at 15 months (difference 11.7, 95% CI 5.8-17.9), and self-reported continuous abstinence rate at 6 months (difference 13.8, 95% CI 6.8-20.8). The remaining 9 outcomes, including the cotinine-validated point prevalence abstinence rate at 15 months, were inconclusive. Conclusions: In this high-intensity outpatient smoking cessation trial, the blended mode was predominantly less effective than the traditional F2F mode. The results contradict the widely assumed potential benefits of blended treatment and suggest that further research is needed to identify the critical factors in the design of blended interventions. Trial Registration: Netherlands Trial Register 27150; https://onderzoekmetmensen.nl/nl/trial/27150 International Registered Report Identifier (IRRID): RR2-doi.org/10.1186/s12889-016-3851-x %M 38376901 %R 10.2196/47040 %U https://www.jmir.org/2024/1/e47040 %U https://doi.org/10.2196/47040 %U http://www.ncbi.nlm.nih.gov/pubmed/38376901 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e49317 %T HealthySMS Text Messaging System Adjunct to Adolescent Group Cognitive Behavioral Therapy in the Context of COVID-19 (Let’s Text!): Pilot Feasibility and Acceptability Study %A Haack,Lauren M %A Armstrong,Courtney C %A Travis,Kate %A Aguilera,Adrian %A Darrow,Sabrina M %+ Department of Psychiatry and Behavioral Sciences, University of California San Francisco, 675 18th Street, San Francisco, CA, 94107, United States, 1 415 502 8060, lauren.haack@ucsf.edu %K depression %K adolescents %K evidence-based intervention %K texting %K SMS text message %K cognitive behavioral therapy %K CBT %K group CBT %K shelter-in-place %K COVID-19 %K mobile health %K mHealth %K therapy %K cognitive %K behavior %K web-based therapy %K e-therapy %K youth %K young adults %K mobile phone %D 2024 %7 19.2.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: The widespread occurrence and devastating impact of adolescent depression warrant health service research focused on feasible and acceptable digital health tools to supplement evidence-based intervention (EBI) efforts, particularly in the context of shelter-in-place guidelines disrupting youth socialization and service use in the wake of the COVID-19 pandemic. Given the promise of SMS text message interventions to enhance EBI engagement, our team developed the HealthySMS system as an adjunct to one of the most empirically supported interventions for adolescent depression: cognitive behavioral therapy (CBT) group services. The system sends daily SMS text messages requesting responses assessing mood, thoughts, and activities; weekly attendance reminder messages; daily tips about adherence (eg, a prompt for activity completion); and personalized responses based on participants’ texts. Objective: This study aims to evaluate the feasibility and acceptability of HealthySMS in a real-world setting and explore potential mechanisms of change in EBI engagement, before evaluating the system’s impact on adolescents’ group CBT engagement and, ultimately, depression outcomes. Methods: Over the course of 2020, we invited all 20 adolescents receiving CBT group services for depression at an outpatient psychiatry clinic to enroll in our HealthySMS study; ultimately, 17 (85%) adolescents agreed to participate. We tracked participant initiation and engagement with the HealthySMS system as well as the content of SMS text message responses to HealthySMS. We also invited each participant to engage in a semistructured interview to gather additional qualitative inputs on the system. Results: All (n=17, 100%) research participants invited agreed to receive HealthySMS messages, and 94% (16/17) of the participants maintained use during the first month without opting out. We uncovered meaningful qualitative themes regarding the feasibility and acceptability of HealthySMS, as well as its potential impact on EBI engagement. Conclusions: Taken together, the results of this pilot study suggest that HealthySMS adjunct to adolescent CBT group depression services is feasible and acceptable, as evidenced by high rates of HealthySMS initiation and low rates of dropout, as well as meaningful themes uncovered from participants’ qualitative feedback. In addition, the findings provide evidence regarding iterative improvements to the HealthySMS system and research protocol, as well as potential mechanisms of change for enhanced EBI engagement and, ultimately, adolescent depression outcomes, which can be used in future effectiveness research. %M 38373030 %R 10.2196/49317 %U https://mental.jmir.org/2024/1/e49317 %U https://doi.org/10.2196/49317 %U http://www.ncbi.nlm.nih.gov/pubmed/38373030 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 11 %N %P e50863 %T A Digital Intervention to Promote Self-Management Self-Efficacy Among Community-Dwelling Individuals With Stroke: Pilot Randomized Controlled Trial %A Li,Zhaoying %A Lei,Yating %A Bui,Quoc %A DePaul,Olivia %A Nicol,Ginger E %A Mohr,David C %A Lee,Sunghoon I %A Fong,Mandy W M %A Metts,Christopher L %A Tomazin,Stephanie E %A Wong,Alex W K %+ Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, 355 E. Erie Street, Chicago, IL, 60611, United States, 1 312 238 1742, wwong@sralab.org %K digital intervention %K feasibility %K mobile health %K participation %K rehabilitation %K self-efficacy %K self-management %K stroke %K technology %K telehealth %K telemedicine %K text messaging %D 2024 %7 19.2.2024 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: Digital interventions provided through smartphones or the internet that are guided by a coach have been proposed as promising solutions to support the self-management of chronic conditions. However, digital intervention for poststroke self-management is limited; we developed the interactive Self-Management Augmented by Rehabilitation Technologies (iSMART) intervention to address this gap. Objective: This study aimed to examine the feasibility and initial effects of the iSMART intervention to improve self-management self-efficacy in people with stroke. Methods: A parallel, 2-arm, nonblinded, randomized controlled trial of 12-week duration was conducted. A total of 24 participants with mild-to-moderate chronic stroke were randomized to receive either the iSMART intervention or a manual of stroke rehabilitation (attention control). iSMART was a coach-guided, technology-supported self-management intervention designed to support people managing chronic conditions and maintaining active participation in daily life after stroke. Feasibility measures included retention and engagement rates in the iSMART group. For both the iSMART intervention and active control groups, we used the Feasibility of Intervention Measure, Acceptability of Intervention Measure, and Intervention Appropriateness Measure to assess the feasibility, acceptability, and appropriateness, respectively. Health measures included the Participation Strategies Self-Efficacy Scale and the Patient-Reported Outcomes Measurement Information System’s Self-Efficacy for Managing Chronic Conditions. Results: The retention rate was 82% (9/11), and the engagement (SMS text message response) rate was 78% for the iSMART group. Mean scores of the Feasibility of Intervention Measure, Acceptability of Intervention Measure, and Intervention Appropriateness Measure were 4.11 (SD 0.61), 4.44 (SD 0.73), and 4.36 (SD 0.70), respectively, which exceeded our benchmark (4 out of 5), suggesting high feasibility, acceptability, and appropriateness of iSMART. The iSMART group showed moderate-to-large effects in improving self-efficacy in managing emotions (r=0.494), symptoms (r=0.514), daily activities (r=0.593), and treatments and medications (r=0.870), but the control group showed negligible-to-small effects in decreasing self-efficacy in managing emotions (r=0.252), symptoms (r=0.262), daily activities (r=0.136), and treatments and medications (r=0.049). In addition, the iSMART group showed moderate-to-large effects of increasing the use of participation strategies for management in the home (r=0.554), work (r=0.633), community (r=0.673), and communication activities (r=0.476). In contrast, the control group showed small-to-large effects of decreasing the use of participation strategies for management in the home (r=0.567), work (r=0.342, community (r=0.215), and communication activities (r=0.379). Conclusions: Our findings support the idea that iSMART was feasible to improve poststroke self-management self-efficacy. Our results also support using a low-cost solution, such as SMS text messaging, to supplement traditional therapeutic patient education interventions. Further evaluation with a larger sample of participants is still needed. Trial Registration: ClinicalTrials.gov 202004137; https://clinicaltrials.gov/study/NCT04743037?id=202004137&rank=1 %M 38373029 %R 10.2196/50863 %U https://rehab.jmir.org/2024/1/e50863 %U https://doi.org/10.2196/50863 %U http://www.ncbi.nlm.nih.gov/pubmed/38373029 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e50113 %T Patient and Therapist Perceptions of a Publicly Funded Internet-Based Cognitive Behavioral Therapy (iCBT) Program for Ontario Adults During the COVID-19 Pandemic: Qualitative Study %A Thapar,Serena %A Nguyen,Megan %A Khan,Bilal Noreen %A Fanaieyan,Roz %A Kishimoto,Vanessa %A Liu,Rebecca %A Bolea-Alamañac,Blanca %A Leon-Carlyle,Marisa %A O’Riordan,Anne %A Keresteci,Maggie %A Bhattacharyya,Onil %+ Institute for Health System Solutions and Virtual Care, Women's College Hospital, 76 Grenville St, Toronto, ON, M5S 1B2, Canada, 1 6474580101, serena.thapar@mail.mcgill.ca %K depression %K anxiety %K cognitive behavioral therapy %K digital health %K internet-delivered cognitive behavioral therapy %K iCBT %K CBT %K implementation %K facilitators %K barriers %K interviews %K qualitative %D 2024 %7 19.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: To address the anticipated rise in mental health symptoms experienced at the population level during the COVID-19 pandemic, the Ontario government provided 2 therapist-assisted internet-delivered cognitive behavioral therapy (iCBT) programs to adults free of charge at the point of service. Objective: The study aims to explore the facilitators of and barriers to implementing iCBT at the population level in Ontario, Canada, from the perspective of patients and therapists to better understand how therapist-assisted iCBT programs can be effectively implemented at the population level and inform strategies for enhancing service delivery and integration into the health care system. Methods: Using a convenience sampling methodology, semistructured interviews were conducted with 10 therapists who delivered iCBT and 20 patients who received iCBT through either of the publicly funded programs to explore their perspectives of the program. Interview data were analyzed using inductive thematic analysis to generate themes. Results: Six salient themes were identified. Facilitators included the therapist-assisted nature of the program; the ease of registration and the lack of cost; and the feasibility of completing the psychoeducational modules given the online and self-paced nature of the program. Barriers included challenges with the online remote modality for developing the therapeutic alliance; the program’s generalized nature, which limited customization to individual needs; and a lack of formal integration between the iCBT program and the health care system. Conclusions: Although the program was generally well-received by patients and therapists due to its accessibility and feasibility, the digital format of the program presented both benefits and unique challenges. Strategies for improving the quality of service delivery include opportunities for synchronous communication between therapists and patients, options for increased customization, and the formal integration of iCBT into a broader stepped-care model that centralizes patient referrals between care providers and promotes continuity of care. %M 38373027 %R 10.2196/50113 %U https://formative.jmir.org/2024/1/e50113 %U https://doi.org/10.2196/50113 %U http://www.ncbi.nlm.nih.gov/pubmed/38373027 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54446 %T Family-Based WhatsApp Intervention to Promote Healthy Eating Behaviors Among Amazonian School Children: Protocol for a Randomized Controlled Trial %A Hovadick,Ana Carolina de Andrade %A Cardoso,Marly Augusto %+ Department of Nutrition, School of Public Health, University of Sao Paulo, Dr. Arnaldo Avenue, 715 - Cerqueira César, Sao Paulo, 01246-904, Brazil, 55 11 3061 7863, marlyac@usp.br %K child health %K Amazon %K dietary intake %K mHealth %K mobile health %K multimedia messaging service %K WhatsApp %D 2024 %7 19.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Stunting and micronutrient deficiencies have persistently affected children in the Brazilian Amazon for decades. However, in recent years, a notable increase in childhood overweight prevalence has been observed, particularly in the context of heightened food insecurity exacerbated by the COVID-19 pandemic. Despite the limited number of effective solutions proposed to tackle this problem, digital interventions have shown great promise worldwide in preventing obesity and promoting healthy diets. Objective: This study aims to describe the protocol of a family-based WhatsApp intervention, specifically designed to investigate the efficacy of multimedia messaging in preventing excessive weight gain and improving healthy eating practices among school-aged children in the Amazon region. Methods: This study protocol outlines a theory-driven randomized controlled trial based on the cognitive theory of multimedia learning and the social cognitive theory. A total of 240 parents or caregivers of children enrolled in the Maternal and Child Health and Nutrition Cohort Study in Acre (MINA-Brazil) will be recruited by phone and social media. The intervention group will receive persuasive multimedia messages through WhatsApp over 19 weeks, while the waitlist control group will remain in the usual care. The primary outcome is a change in children’s BMI in z score. Secondary outcomes are changes in dietary intake and biochemical indicators of the children. Outcome measures will be assessed at baseline and 5 months after randomization in comparison to usual care. The analysis will use an intent-to-treat approach and will be conducted using the statistical package Stata (version 18.0), with a significance level set at P<.05. Paired and unpaired 2-tailed t tests will be applied to compare mean changes in the outcomes. Results: Data collection started in June 2023, and final measurements are scheduled to be completed in December 2023. The results of the main analysis are expected to be available in 2024. Conclusions: This innovative multimedia message intervention holds significant potential for fostering behavioral changes among Amazonian children. Trial Registration: Brazilian Clinical Trials Registry RBR-5zdnw6t; https://ensaiosclinicos.gov.br/rg/RBR-5zdnw6t International Registered Report Identifier (IRRID): DERR1-10.2196/54446 %M 38373039 %R 10.2196/54446 %U https://www.researchprotocols.org/2024/1/e54446 %U https://doi.org/10.2196/54446 %U http://www.ncbi.nlm.nih.gov/pubmed/38373039 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e52776 %T Mobile Intervention to Address Cannabis Use Disorder Among Black Adults: Protocol for a Randomized Controlled Trial %A Nizio,Pamella %A Clausen,Bryce %A Businelle,Michael S %A Ponton,Natalia %A Jones,Ava A %A Redmond,Brooke Y %A Buckner,Julia D %A Obasi,Ezemenari M %A Zvolensky,Michael J %A Garey,Lorra %+ University of Houston, 3695 Cullen Blvd., Room 104, Houston, TX, 77204, United States, 1 7137438056, llgarey@uh.edu %K cannabis use %K false safety behaviors %K mobile health, just-in-time adaptive interventions %K Black or African American %K mobile phone %K African American %K Black %K cannabis %K adults %K adult %K Hispanic %K Latin %K adaptive intervention %K cannabis reduction %K cessation %K ecological momentary assessments %D 2024 %7 19.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: African American or Black (hereafter referred to as Black) adults who use cannabis use it more frequently and are more likely to meet criteria for cannabis use disorder (CUD) than both White and Hispanic or Latin individuals. Black adults may be more apt to use cannabis to cope with distress, which constitutes a false safety behavior (FSB; a behavior designed to reduce psychological distress in the short term). Although FSB engagement can perpetuate the cycle of high rates of CUD among Black individuals, limited work has applied an FSB elimination treatment approach to Black adults with CUD, and no previous work has evaluated FSB reduction or elimination in the context of a culturally tailored and highly accessible treatment developed for Black individuals. Objective: This study aims to develop and pilot-test a culturally tailored adaptive intervention that integrates FSB reduction or elimination skills for cannabis reduction or cessation among Black adults with probable CUD (Culturally Tailored-Mobile Integrated Cannabis and Anxiety Reduction Treatment [CT-MICART]). Methods: Black adults with probable CUD (N=50) will complete a web-based screener, enrollment call, baseline assessment, 3 daily ecological momentary assessments (EMAs) for 6 weeks, and a follow-up self-report assessment and qualitative interview at 6 weeks after randomization. Participants will be randomized into 1 out of the 2 conditions after baseline assessment: (1) CT-MICART+EMAs for 6 weeks or (2) EMAs only for 6 weeks. Results: The enrollment started in June 2023 and ended in November 2023. Data analysis will be completed in March 2024. Conclusions: No culturally tailored, evidence-based treatment currently caters to the specific needs of Black individuals with CUD. This study will lay the foundation for a new approach to CUD treatment among Black adults that is easily accessible and has the potential to overcome barriers to treatment and reduce practitioner burden in order to support Black individuals who use cannabis with probable CUD. Trial Registration: ClinicalTrials.gov NCT05566730; https://clinicaltrials.gov/study/NCT05566730 International Registered Report Identifier (IRRID): DERR1-10.2196/52776 %M 38373037 %R 10.2196/52776 %U https://www.researchprotocols.org/2024/1/e52776 %U https://doi.org/10.2196/52776 %U http://www.ncbi.nlm.nih.gov/pubmed/38373037 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e47216 %T Efficacy of a Digital Health Preventive Intervention for Adolescents With HIV or Sexually Transmitted Infections and Substance Use Disorder: Protocol for a Randomized Controlled Trial %A Cordova,David %A Bauermeister,José A %A Warner,Sydni %A , %A Wells,Patricia %A MacLeod,Jennifer %A Neilands,Torsten B %A Mendoza Lua,Frania %A Delva,Jorge %A Fessler,Kathryn Bondy %A Smith Jr,Versell %A Khreizat,Sarah %A Boyer,Cherrie %+ School of Social Work, University of Michigan, 1080 South University Avenue, Ann Arbor, MI, 48109, United States, 1 734 763 6201, cordovad@umich.edu %K youth %K mHealth %K HIV %K STI %K illicit drugs %K primary care %K prevention %K public health %K USA %K teens %K drugs %K drug use %K sex %K racial minority %K risk behavior %K engagement %K tool %K substance use disorder %D 2024 %7 19.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: HIV or sexually transmitted infections remain a significant public health concern in the United States, with adolescents affected disproportionately. Adolescents engage in HIV/STI risk behaviors, including drug use and condomless sex, which increase the risk for HIV/STIs. At-risk adolescents, many of whom are racial minorities, experience HIV/STI disparities. Although at-risk adolescents are disproportionately affected by HIV/STI risk behaviors and infections and although the Centers for Disease Control and Prevention recommends routine HIV/STI testing for adolescents, relatively few adolescents report having ever been tested for HIV/STI. With expected increases in health clinic visits as a result of the Affordable Care Act combined with technological advances, health clinics and mobile health (mHealth), including apps, provide innovative contexts and tools to engage at-risk adolescents in HIV/STI prevention programs. Yet, there is a dearth of efficacious mHealth interventions in health clinics to prevent and reduce both condomless sex and drug use and increase HIV/STI testing for at-risk adolescents. Objective: To address this gap in knowledge, we developed a theory-driven, culturally congruent mHealth intervention (hereon referred to as S4E [Storytelling 4 Empowerment]) that has demonstrated feasibility and acceptability in a clinical setting. The next step is to examine the preliminary efficacy of S4E on adolescent HIV/STI testing and risk behaviors. This goal will be accomplished by 2 aims: the first aim is to develop a cross-platform and universal version of S4E. The cross-platform and universal version of S4E will be compatible with both iOS and Android operating systems and multiple mobile devices, aimed at providing adolescents with ongoing access to the intervention once they leave the clinic, and the second aim is to evaluate the preliminary efficacy of S4E, relative to usual care control condition, in preventing or reducing drug use and condomless sex and increasing HIV/STI testing in a clinical sample of at-risk adolescents aged 14-21 years living in Southeast Michigan. Methods: In this study, 100 adolescents recruited from a youth-centered community health clinic will be randomized via blocked randomization with random sequences of block sizes to one of the 2 conditions: S4E mHealth intervention or usual care. Theory-driven and culturally congruent, S4E is an mHealth adaptation of face-to-face storytelling for empowerment, which is registered with the Substance Abuse and Mental Health Services Administration's National Registry of Evidence-Based Programs and Practices. Results: This paper describes the protocol of our study. The recruitment began on May 1, 2018. This study was registered on December 11, 2017, in ClinicalTrials.gov. All participants have been recruited. Data analysis will be complete by the end of March 2024, with study findings available by December 2024. Conclusions: This study has the potential to improve public health by preventing HIV/STI and substance use disorders. Trial Registration: ClinicalTrials.gov NCT03368456; https://clinicaltrials.gov/study/NCT03368456 International Registered Report Identifier (IRRID): DERR1-10.2196/47216 %M 38373025 %R 10.2196/47216 %U https://www.researchprotocols.org/2024/1/e47216 %U https://doi.org/10.2196/47216 %U http://www.ncbi.nlm.nih.gov/pubmed/38373025 %0 Journal Article %@ 2562-7600 %I JMIR Publications %V 7 %N %P e54561 %T mHealth Gratitude Exercise Mindfulness App for Resiliency Among Neonatal Intensive Care Unit Staff: Three-Arm Pretest-Posttest Interventional Study %A Peterson,Neil E %A Thomas,Michael %A Hunsaker,Stacie %A Stewart,Tevin %A Collett,Claire J %+ College of Nursing, Brigham Young University, 500 Spencer West Kimball Tower (KMBL), Provo, UT, 84602, United States, 1 8014224893, neil-peterson@byu.edu %K burnout %K compassion fatigue %K compassion satisfaction %K secondary trauma %K trauma %K satisfaction %K compassion %K gratitude %K resilience %K quality of life %K QoL %K mindfulness %K meditation %K exercise %K happiness %K mHealth %K mobile health %K app %K apps %K applications %K neonatal intensive care unit %K NICU %K intensive care unit %K ICU %K intensive care %K nurse %K nurses %K nursing %K health care worker %K health care workers %K provider %K providers %K phone app %K physical activity %K resiliency %K mobile phone %D 2024 %7 16.2.2024 %9 Original Paper %J JMIR Nursing %G English %X Background: Health care is highly complex and can be both emotionally and physically challenging. This can lead health care workers to develop compassion fatigue and burnout (BO), which can negatively affect their well-being and patient care. Higher levels of resilience can potentially prevent compassion fatigue and BO. Strategies that enhance resilience include gratitude, exercise, and mindfulness. Objective: The purpose of this study was to determine if a 3-week daily resiliency practice, prompted via a gratitude, exercise, and mindfulness smartphone app, impacted the professional quality of life, physical activity, and happiness level of health care workers in a newborn intensive care unit setting. Methods: In total, 65 participants from a level III newborn intensive care unit at a regional hospital in the western United States completed this study. The Professional Quality of Life Scale, Physical Activity Vital Sign, and Subjective Happiness Score instruments were used to evaluate the effects of the mobile health (mHealth) intervention. Further, 2-tailed dependent paired t tests were used to evaluate participant pre- and postintervention instrument scores. Multiple imputation was used to predict scores of participants who practiced an intervention but did not complete the 3 instruments post intervention. Results: Dependent t tests using the original data showed that participants, as a whole, significantly improved in BO (t35=2.30, P=.03), secondary trauma stress (STS; t35=2.11, P=.04), and happiness (t35=–3.72, P<.001) scores. Compassion satisfaction (CS; t35=–1.94, P=.06) and exercise (t35=–1.71, P=.10) were trending toward, but did not reach, significance. Using the original data, only the gratitude intervention group experienced significant improvements (CS, BO, and happiness), likely due to the higher number of participants in this group. Analysis using imputed data showed that participants, as a whole, had significant improvements in all areas: CS (t64=–4.08, P<.001), BO (t64=3.39, P=.001), STS (t64=4.08, P<.001), exercise (t64=–3.19, P=.002), and happiness (t64=–3.99, P<.001). Looking at the intervention groups separately using imputed data, the gratitude group had significant improvements in CS, BO, STS, and happiness; the exercise group had significant improvements in STS and exercise; and the mindfulness group had significant improvements in CS and happiness. Conclusions: Phone app delivery of resilience-enhancing interventions is a potentially effective intervention model for health care workers. Potential barriers to mHealth strategies are the technical issues that can occur with this type of intervention. Additional longitudinal and experimental studies with larger sample sizes need to be completed to better evaluate this modality. %M 38363595 %R 10.2196/54561 %U https://nursing.jmir.org/2024/1/e54561 %U https://doi.org/10.2196/54561 %U http://www.ncbi.nlm.nih.gov/pubmed/38363595 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e49839 %T Mobile App–Based Lifestyle Coaching Intervention for Patients With Nonalcoholic Fatty Liver Disease: Randomized Controlled Trial %A Kwon,Oh Young %A Lee,Mi Kyung %A Lee,Hye Won %A Kim,Hyerang %A Lee,Jae Seung %A Jang,Yeonsoo %+ College of Nursing, Mo-Im Kim Nursing Research Institute, Yonsei University, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea, 82 2 2228 3343, ysjang517@yuhs.ac %K lifestyle modification %K mobile health %K nonalcoholic fatty liver disease %K self-management %K randomized controlled trial %D 2024 %7 15.2.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Lifestyle modification in patients with nonalcoholic fatty liver disease (NAFLD) is key to improving health outcomes. Mobile health technologies may offer potential effective and efficient health care support to facilitate self-management. Objective: This study aims to develop a lifestyle coaching intervention using a mobile app for patients with NAFLD and evaluate physiological and psychological health outcomes for 6 months. Methods: This study was a randomized controlled trial. The personalized lifestyle coaching intervention using a mobile app was developed through established guidelines and literature reviews. This intervention consisted of information on NAFLD management, diet and physical activity self-monitoring, and coaching sessions based on patient records and SMS text messages. A total of 102 individuals were enrolled in the study and randomly assigned to the intervention group (n=48) or the control group (n=54). The outcomes were improvements in physiological (weight, liver fat score, aspartate aminotransferase, alanine transferase, and gamma-glutamyl transferase) and clinical outcomes (self-management, NAFLD self-management knowledge, self-efficacy, fatigue, depression, and quality of life). Data were analyzed using descriptive analysis and a linear mixed model to test the effects of the intervention. Results: All participants completed the study. The mean age of the participants was 48.9 (SD 13.74) years, 38.2% (39/102) were female participants, and 65.7% (67/102) were married. There were no differences in baseline demographic and clinical data between the intervention and control groups. Changes from baseline to 6 months were significant only within the intervention group for weight (P<.001), liver fat score (P=.01), aspartate aminotransferase (P=.03), alanine transferase (P=.002), gamma-glutamyl transferase (P=.04), self-management (P<.001), fatigue (P=.005), depression (P=.003), and quality of life (P<.001). The differences between the 2 groups for the changes over the 6 months were significant in self-management (P=.004), self-management knowledge (P=.04), fatigue (P=.004), depression (P=.04), and quality of life (P=.01). However, the intervention-by-time interaction was significantly effective only for self-management (P=.006) and fatigue (P=.02). Conclusions: Nonpharmacological interventions using a mobile app may be effective in improving the physiological and psychological health outcomes of patients with NAFLD. Trial Registration: Clinical Research Information Service KCT0005549; http://tinyurl.com/y2zb6usy %M 38358794 %R 10.2196/49839 %U https://www.jmir.org/2024/1/e49839 %U https://doi.org/10.2196/49839 %U http://www.ncbi.nlm.nih.gov/pubmed/38358794 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e48971 %T Formative Perceptions of a Digital Pill System to Measure Adherence to Heart Failure Pharmacotherapy: Mixed Methods Study %A Chai,Peter R %A Kaithamattam,Jenson J %A Chung,Michelle %A Tom,Jeremiah J %A Goodman,Georgia R %A Hasdianda,Mohammad Adrian %A Carnes,Tony Christopher %A Vaduganathan,Muthiah %A Scirica,Benjamin M %A Schnipper,Jeffrey L %+ Department of Emergency Medicine, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA, 02115, United States, 1 617 732 5640, pchai@bwh.harvard.edu %K behavioral interventions %K cardiac treatment %K digital pill system %K heart failure medication %K heart failure %K ingestible sensors %K medication adherence %D 2024 %7 15.2.2024 %9 Original Paper %J JMIR Cardio %G English %X Background: Heart failure (HF) affects 6.2 million Americans and is a leading cause of hospitalization. The mainstay of the management of HF is adherence to pharmacotherapy. Despite the effectiveness of HF pharmacotherapy, effectiveness is closely linked to adherence. Measuring adherence to HF pharmacotherapy is difficult; most clinical measures use indirect strategies such as calculating pharmacy refill data or using self-report. While helpful in guiding treatment adjustments, indirect measures of adherence may miss the detection of suboptimal adherence and co-occurring structural barriers associated with nonadherence. Digital pill systems (DPSs), which use an ingestible radiofrequency emitter to directly measure medication ingestions in real-time, represent a strategy for measuring and responding to nonadherence in the context of HF pharmacotherapy. Previous work has demonstrated the feasibility of using DPSs to measure adherence in other chronic diseases, but this strategy has yet to be leveraged for individuals with HF. Objective: We aim to explore through qualitative interviews the facilitators and barriers to using DPS technology to monitor pharmacotherapy adherence among patients with HF. Methods: We conducted individual, semistructured qualitative interviews and quantitative assessments between April and August 2022. A total of 20 patients with HF who were admitted to the general medical or cardiology service at an urban quaternary care hospital participated in this study. Participants completed a qualitative interview exploring the overall acceptability of and willingness to use DPS technology for adherence monitoring and perceived barriers to DPS use. Quantitative assessments evaluated HF history, existing medication adherence strategies, and attitudes toward technology. We analyzed qualitative data using applied thematic analysis and NVivo software (QSR International). Results: Most participants (12/20, 60%) in qualitative interviews reported a willingness to use the DPS to measure HF medication adherence. Overall, the DPS was viewed as useful for increasing accountability and reinforcing adherence behaviors. Perceived barriers included technological issues, a lack of need, additional costs, and privacy concerns. Most were open to sharing adherence data with providers to bolster clinical care and decision-making. Reminder messages following detected nonadherence were perceived as a key feature, and customization was desired. Suggested improvements are primarily related to the design and usability of the Reader (a wearable device). Conclusions: Overall, individuals with HF perceived the DPS to be an acceptable and useful tool for measuring medication adherence. Accurate, real-time ingestion data can guide adherence counseling to optimize adherence management and inform tailored behavioral interventions to support adherence among patients with HF. %M 38358783 %R 10.2196/48971 %U https://cardio.jmir.org/2024/1/e48971 %U https://doi.org/10.2196/48971 %U http://www.ncbi.nlm.nih.gov/pubmed/38358783 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e52576 %T User Engagement, Acceptability, and Clinical Markers in a Digital Health Program for Nonalcoholic Fatty Liver Disease: Prospective, Single-Arm Feasibility Study %A Björnsdottir,Sigridur %A Ulfsdottir,Hildigunnur %A Gudmundsson,Elias Freyr %A Sveinsdottir,Kolbrun %A Isberg,Ari Pall %A Dobies,Bartosz %A Akerlie Magnusdottir,Gudlaug Erla %A Gunnarsdottir,Thrudur %A Karlsdottir,Tekla %A Bjornsdottir,Gudlaug %A Sigurdsson,Sigurdur %A Oddsson,Saemundur %A Gudnason,Vilmundur %+ Department of Endocrinology, Metabolism and Diabetes, Karolinska Institutet, Solnavägen 1, Stockholm, 171 77, Sweden, 46 8 524 800 00, sigridur.bjornsdottir@ki.se %K digital health program %K nonalcoholic fatty liver disease %K NAFLD %K cardiometabolic health %K digital therapeutics %K liver %K chronic %K hepatic %K cardiometabolic %K cardiovascular %K cardiology %K weight %K acceptability %K digital health %K metabolic syndrome %K diabetic %K diabetes %K diabetics %K type 2 %K BMI %K lifestyle %K exercise %K physical activity %K coaching %K diet %K dietary %K nutrition %K nutritional %K patient education %K coach %K feasibility %K fat %K body composition %D 2024 %7 15.2.2024 %9 Original Paper %J JMIR Cardio %G English %X Background: Nonalcoholic fatty liver disease (NAFLD) has become the most common chronic liver disease in the world. Common comorbidities are central obesity, type 2 diabetes mellitus, dyslipidemia, and metabolic syndrome. Cardiovascular disease is the most common cause of death among people with NAFLD, and lifestyle changes can improve health outcomes. Objective: This study aims to explore the acceptability of a digital health program in terms of engagement, retention, and user satisfaction in addition to exploring changes in clinical outcomes, such as weight, cardiometabolic risk factors, and health-related quality of life. Methods: We conducted a prospective, open-label, single-arm, 12-week study including 38 individuals with either a BMI >30, metabolic syndrome, or type 2 diabetes mellitus and NAFLD screened by FibroScan. An NAFLD-specific digital health program focused on disease education, lowering carbohydrates in the diet, food logging, increasing activity level, reducing stress, and healthy lifestyle coaching was offered to participants. The coach provided weekly feedback on food logs and other in-app activities and opportunities for participants to ask questions. The coaching was active throughout the 12-week intervention period. The primary outcome was feasibility and acceptability of the 12-week program, assessed through patient engagement, retention, and satisfaction with the program. Secondary outcomes included changes in weight, liver fat, body composition, and other cardiometabolic clinical parameters at baseline and 12 weeks. Results: In total, 38 individuals were included in the study (median age 59.5, IQR 46.3-68.8 years; n=23, 61% female). Overall, 34 (89%) participants completed the program and 29 (76%) were active during the 12-week program period. The median satisfaction score was 6.3 (IQR 5.8-6.7) of 7. Mean weight loss was 3.5 (SD 3.7) kg (P<.001) or 3.2% (SD 3.4%), with a 2.2 (SD 2.7) kg reduction in fat mass (P<.001). Relative liver fat reduction was 19.4% (SD 23.9%). Systolic blood pressure was reduced by 6.0 (SD 13.5) mmHg (P=.009). The median reduction was 0.14 (IQR 0-0.47) mmol/L for triglyceride levels (P=.003), 3.2 (IQR 0.0-5.4) µU/ml for serum insulin (s-insulin) levels (P=.003), and 0.5 (IQR –0.7 to 3.8) mmol/mol for hemoglobin A1c (HbA1c) levels (P=.03). Participants who were highly engaged (ie, who used the app at least 5 days per week) had greater weight loss and liver fat reduction. Conclusions: The 12-week-long digital health program was feasible for individuals with NAFLD, receiving high user engagement, retention, and satisfaction. Improved liver-specific and cardiometabolic health was observed, and more engaged participants showed greater improvements. This digital health program could provide a new tool to improve health outcomes in people with NAFLD. Trial Registration: Clinicaltrials.gov NCT05426382; https://clinicaltrials.gov/study/NCT05426382 %M 38152892 %R 10.2196/52576 %U https://cardio.jmir.org/2024/1/e52576 %U https://doi.org/10.2196/52576 %U http://www.ncbi.nlm.nih.gov/pubmed/38152892 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e38803 %T Use Intention and User Expectations of Human-Supported and Self-Help eHealth Interventions: Internet-Based Randomized Controlled Trial %A Cohen Rodrigues,Talia R %A Reijnders,Thomas %A Breeman,Linda D %A Janssen,Veronica R %A Kraaijenhagen,Roderik A %A Atsma,Douwe E %A Evers,Andrea WM %+ Health, Medical, and Neuropsychology Unit, Leiden University, Wassenaarseweg 52, Leiden, 2333 AK, Netherlands, 31 71 527 3627, t.r.cohen.rodrigues@fsw.leidenuniv.nl %K eHealth %K human support %K Unified Theory of Acceptance and Use of Technology %K use intention %K UTAUT %K working alliance %D 2024 %7 15.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Self-help eHealth interventions provide automated support to change health behaviors without any further human assistance. The main advantage of self-help eHealth interventions is that they have the potential to lower the workload of health care professionals. However, one disadvantage is that they generally have a lower uptake. Possibly, the absence of a relationship with a health care professional (referred to as the working alliance) could lead to negative expectations that hinder the uptake of self-help interventions. The Unified Theory of Acceptance and Use of Technology (UTAUT) identifies which expectations predict use intention. As there has been no previous research exploring how expectations affect the adoption of both self-help and human-supported eHealth interventions, this study is the first to investigate the impact of expectations on the uptake of both kinds of eHealth interventions. Objective: This study investigated the intention to use a self-help eHealth intervention compared to a human-supported eHealth intervention and the expectations that moderate this relationship. Methods: A total of 146 participants were randomly assigned to 1 of 2 conditions (human-supported or self-help eHealth interventions). Participants evaluated screenshots of a human-supported or self-help app–based stress intervention. We measured intention to use the intervention-expected working alliance and the UTAUT constructs: performance expectancy, effort expectancy, and social influence. Results: Use intention did not differ significantly between the 2 conditions (t142=–1.133; P=.26). Performance expectancy (F1,140=69.269; P<.001), effort expectancy (F1,140=3.961; P=.049), social influence (F1,140=90.025; P<.001), and expected working alliance (F1,140=26.435; P<.001) were positively related to use intention regardless of condition. The interaction analysis showed that performance expectancy (F1,140=4.363; P=.04) and effort expectancy (F1,140=4.102; P=.045) more strongly influenced use intention in the self-help condition compared to the human-supported condition. Conclusions: As we found no difference in use intention, our results suggest that we could expect an equal uptake of self-help eHealth interventions and human-supported ones. However, attention should be paid to people who have doubts about the intervention’s helpfulness or ease of use. For those people, providing additional human support would be beneficial to ensure uptake. Screening user expectations could help health care professionals optimize self-help eHealth intervention uptake in practice. Trial Registration: OSF Registries osf.io/n47cz; https://osf.io/n47cz %M 38358784 %R 10.2196/38803 %U https://formative.jmir.org/2024/1/e38803 %U https://doi.org/10.2196/38803 %U http://www.ncbi.nlm.nih.gov/pubmed/38358784 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e48817 %T Dietary Intake Assessment Using a Novel, Generic Meal–Based Recall and a 24-Hour Recall: Comparison Study %A O'Hara,Cathal %A Gibney,Eileen R %+ University College Dublin Institute of Food and Health, Science Centre South, University College Dublin, Belfield, Dublin, D04 N2E5, Ireland, 353 17162819, eileen.gibney@ucd.ie %K meal patterns %K eating behaviors %K eating occasions %K nutrition assessment %K dietary intake assessment %K 24-hour recall %K relative validity %D 2024 %7 14.2.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Dietary intake assessment is an integral part of addressing suboptimal dietary intakes. Existing food-based methods are time-consuming and burdensome for users to report the individual foods consumed at each meal. However, ease of use is the most important feature for individuals choosing a nutrition or diet app. Intakes of whole meals can be reported in a manner that is less burdensome than reporting individual foods. No study has developed a method of dietary intake assessment where individuals report their dietary intakes as whole meals rather than individual foods. Objective: This study aims to develop a novel, meal-based method of dietary intake assessment and test its ability to estimate nutrient intakes compared with that of a web-based, 24-hour recall (24HR). Methods: Participants completed a web-based, generic meal–based recall. This involved, for each meal type (breakfast, light meal, main meal, snack, and beverage), choosing from a selection of meal images those that most represented their intakes during the previous day. Meal images were based on generic meals from a previous study that were representative of the actual meal intakes in Ireland. Participants also completed a web-based 24HR. Both methods were completed on the same day, 3 hours apart. In a crossover design, participants were randomized in terms of which method they completed first. Then, 2 weeks after the first dietary assessments, participants repeated the process in the reverse order. Estimates of mean daily nutrient intakes and the categorization of individuals according to nutrient-based guidelines (eg, low, adequate, and high) were compared between the 2 methods. P values of less than .05 were considered statistically significant. Results: In total, 161 participants completed the study. For the 23 nutrient variables compared, the median percentage difference between the 2 methods was 7.6% (IQR 2.6%-13.2%), with P values ranging from <.001 to .97, and out of 23 variables, effect sizes for the differences were small for 19 (83%) variables, moderate for 2 (9%) variables, and large for 2 (9%) variables. Correlation coefficients were statistically significant (P<.05) for 18 (78%) of the 23 variables. Statistically significant correlations ranged from 0.16 to 0.45, with median correlation of 0.32 (IQR 0.25-0.40). When participants were classified according to nutrient-based guidelines, the proportion of individuals who were classified into the same category ranged from 52.8% (85/161) to 84.5% (136/161). Conclusions: A generic meal–based method of dietary intake assessment provides estimates of nutrient intake comparable with those provided by a web-based 24HR but with varying levels of agreement among nutrients. Further studies are required to refine and improve the generic recall across a range of nutrients. Future studies will consider user experience including the potential feasibility of incorporating image recognition of whole meals into the generic recall. %M 38354039 %R 10.2196/48817 %U https://www.jmir.org/2024/1/e48817 %U https://doi.org/10.2196/48817 %U http://www.ncbi.nlm.nih.gov/pubmed/38354039 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e51908 %T Effect of a Mobile Game–Based Intervention to Enhance Child Safety: Randomized Controlled Trial %A Wong,Rosa S %A Tung,Keith T S %A Ho,Frederick K W %A Wong,Wilfred H S %A Chow,Chun Bong %A Chan,Ko Ling %A Fu,King Wa %A Ip,Patrick %+ Department of Paediatrics and Adolescent Medicine, The University of Hong Kong, Pok Fu Lam, Hong Kong, China (Hong Kong), 852 22554090, patricip@hku.hk %K mobile game %K injury prevention %K safety education %K unintentional injuries %K gamification %K game %K games %K gaming %K safety %K injury %K injuries %K gamify %K gamified %K child %K children %K youth %K pediatric %K pediatrics %K danger %K hazard %K hazards %K RCT %K randomized %K controlled trial %K controlled trials %K mobile phone %D 2024 %7 14.2.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Evidence supports the effectiveness of serious games in health education, but little is known about their effects on the psychosocial well-being of children in the general population. Objective: This study aimed to investigate the potential of a mobile game–based safety education program in improving children’s safety and psychosocial outcomes. Methods: Safe City is a mobile roleplaying game specifically designed to educate children in Hong Kong about safety. This randomized controlled trial included 340 children in grades 4 through 6. Intervention arm participants (n=170) were instructed to play the Safe City mobile game for 4 weeks, whereas control arm participants (n=170) received a safety booklet. All participants completed a survey on safety knowledge and behaviors and psychosocial problems at baseline (T1), 1 month postintervention (T2), and 3 months postintervention (T3). Cumulative game scores and mini-game performance were analyzed as a proxy for the extent of exposure to the game. Outcome data were analyzed using 2-sample 2-tailed t tests to compare mean change from T1 to T2 and to T3 for intervention versus control arm participants. The association of game use with outcome changes postintervention was analyzed using generalized additive models. Results: No significant differences were found in mean changes between the intervention and control arms. However, use analyses showed that higher game scores were associated with improvements in safe behavior (P=.03) and internalizing problems (P=.01) at T3. Matching and Spot the Danger mini-game performance significantly predicted improvements in safety knowledge at T2 and T3. Conclusions: Analysis of use has shown that playing the Safe City mobile game can result in significant improvements in safety knowledge and reductions in unsafe behavior and internalizing problems. These findings provide evidence for the positive impact of serious games on psychological and social well-being, highlighting the potential of technology-driven interventions to assist children in learning about safety and preventing injuries. Trial Registration: ClinicalTrials.org NCT04096196; https://clinicaltrials.gov/show/NCT04096196 International Registered Report Identifier (IRRID): RR2-10.2196/17756 %M 38354042 %R 10.2196/51908 %U https://www.jmir.org/2024/1/e51908 %U https://doi.org/10.2196/51908 %U http://www.ncbi.nlm.nih.gov/pubmed/38354042 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e47181 %T Determining the Right Levels of Health Coaching and Heart Rate Variability Biofeedback in a Workplace Behavior Change Intervention: Multiphase Optimization Strategy Preparation Study %A Locke,Sean %A Osborne,Jenna %+ Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St Catharines, ON, L2S 3A1, Canada, 1 905 668 5550 ext 4958, slocke@brocku.ca %K mobile health %K mHealth %K behavior change %K stress management %K intervention %K pilot study %K heart rate variability %K health coaching %K coach %K coaching %K coaches %K work-related stress %K stress %K wellness %K burnout %K behavioral intervention %K work %K worker %K workers %K employee %K employees %K occupational health %K job %K satisfaction %K web-based %K remote %K corporate %K web analytics %K biofeedback %K survey %K surveys %K interview %K interviews %K experience %K experiences %K attitude %K attitudes %K opinion %K opinion %K perception %K perceptions %K perspective %K perspectives %K acceptance %D 2024 %7 14.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Work-related stress is associated with poor job performance and negative health outcomes. Changing health behaviors through corporate wellness programs can improve physical and mental health and help employees manage stress. This project sought to pilot the potential addition of brief coaching and biofeedback to an 8-week web-based self-help program to improve employee stress using the multiphase optimization strategy. Objective: This study aims to determine which candidate components will be tested in a later optimization phase and at what dose they will be tested, examine the feasibility and acceptability of delivering the different components, investigate whether the outcomes can be feasibly measured, and review evidence to build a conceptual model before the optimization phase. Methods: The study was positioned within the preparation phase of the multiphase optimization strategy. It is a 2×2×2×2 design with 4 components: 2 types of health coaching and 2 types of biofeedback. All components were tested by turning them on or off. A total of 16 adult office workers (mean age 40, SD 14.3 years; n=15 women) completed an 8-week self-paced web-based stress management and health behavior change program and were randomly assigned to 1 of the 16 conditions, created from a combination of the 4 candidate components. Assessments included web analytics, surveys, and interviews regarding program recommendations, likes, and dislikes. Results: Findings from the interviews provided suggestions to improve the intervention (eg, separating wellness from stress content) and trial conduct (eg, streamlining the onboarding process). On average, participants logged into the wellness program 83 times (range 36-291), with 75% (12/16) participant retention and 67% (8/12) survey completion. There were no reported problems with coaching or obtaining data from interviews or apps. The interview findings suggested potential mediators to include and assess in a future conceptual model. Conclusions: The results provided areas to improve the intervention content and trial methods. Instead of progressing to the next scheduled large-scale optimization phase, our plan to iterate through a second preparation phase after making changes to the protocol, apps, and corporate coaching partner. %M 38354036 %R 10.2196/47181 %U https://formative.jmir.org/2024/1/e47181 %U https://doi.org/10.2196/47181 %U http://www.ncbi.nlm.nih.gov/pubmed/38354036 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e49322 %T The Effect of Web-Based Culinary Medicine to Enhance Protein Intake on Muscle Quality in Older Adults: Randomized Controlled Trial %A Salas-Groves,Emily %A Alcorn,Michelle %A Childress,Allison %A Galyean,Shannon %+ Nutritional Sciences, Texas Tech University, 1301 Akron Avenue, Lubbock, TX, 79409, United States, 1 806 834 2286, shannon.galyean@ttu.edu %K older adults %K culinary medicine %K protein %K muscle mass %K muscle strength %K physical activity %K nutrition intervention %K online %D 2024 %7 13.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: The most common age-related musculoskeletal disorder is sarcopenia. Sarcopenia is the progressive and generalized loss of muscle mass, strength, and function. The causes of sarcopenia can include insufficient nutritional status, which may be due to protein-energy malnutrition, anorexia, limited food access and eating ability, or malabsorption. In the United States, 15.51% of older adults have been diagnosed with sarcopenia. Culinary medicine (CM) is a novel evidence-based medical field that combines the science of medicine with food and cooking to prevent and treat potential chronic diseases. CM helps individuals learn and practice culinary skills while tasting new recipes. Therefore, this program could successfully reduce barriers to protein intake, enabling older adults to enhance their diet and muscle quality. Objective: This study aimed to examine how a web-based CM intervention, emphasizing convenient ways to increase lean red meat intake, could improve protein intake with the promotion of physical activity to see how this intervention could affect older adults’ muscle strength and mass. Methods: A 16-week, single-center, parallel-group, randomized controlled trial was conducted to compare a web-based CM intervention group (CMG) with a control group (CG) while monitoring each group’s muscle strength, muscle mass, and physical activity for muscle quality. The CMG received weekly web-based cooking demonstrations and biweekly nutrition education videos about enhancing protein intake, whereas the CG just received the recipe handout. Anthropometrics, muscle mass, muscle strength, dietary habits, physical activity, and cooking effectiveness were established at baseline and measured after the intervention. The final number of participants for the data analysis was 24 in the CMG and 23 in the CG. Results: No between-group difference in muscle mass (P=.88) and strength (dominant P=.92 and nondominant P=.72) change from the prestudy visit was detected. No statistically significant difference in protein intake was seen between the groups (P=.50). A nonsignificant time-by-intervention interaction was observed for daily protein intake (P=.08). However, a statistically significant time effect was observed (P≤.001). Post hoc testing showed that daily protein intake was significantly higher at weeks 1 to 16 versus week 0 (P<.05). At week 16, the intake was 16.9 (95% CI 5.77-27.97) g higher than that at the prestudy visit. Conclusions: This study did not affect protein intake and muscle quality. Insufficient consistent protein intake, low physical activity, intervention adherence, and questionnaire accuracy could explain the results. These studies could include an interdisciplinary staff, different recruitment strategies, and different muscle mass measurements. Future research is needed to determine if this intervention is sustainable in the long term and should incorporate a follow-up to determine program efficacy on several long-term behavioral and health outcomes, including if the participants can sustain their heightened protein intake and how their cooking skills have changed. Trial Registration: ClinicalTrials.gov NCT05593978; https://clinicaltrials.gov/ct2/show/NCT05593978 %M 38349721 %R 10.2196/49322 %U https://formative.jmir.org/2024/1/e49322 %U https://doi.org/10.2196/49322 %U http://www.ncbi.nlm.nih.gov/pubmed/38349721 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e45471 %T Nonuse of Blended Web-Based and Face-To-Face Cognitive Behavioral Therapy for Alcohol Use Disorder: Qualitative Study %A Tarp,Kristine %A Christiansen,Regina %A Bilberg,Randi %A Borkner,Simone %A Dalsgaard,Caroline %A Folker,Marie Paldam %A Nielsen,Anette Søgaard %+ The National Research Centre for the Working Environment, Lersø Parkallé 105, Copenhagen, 2100, Denmark, 45 21292332, ket@nfa.dk %K alcohol use disorder %K blended internet-based and face-to-face cognitive behavioral therapy %K nonuse %K patient perceptions %K qualitative %D 2024 %7 13.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: The use of digital technologies for health care has been the focus of social studies, which have concentrated on the digital divide between individuals who use technology and those who do not—with the latter often being considered as individuals with shortcomings. In Denmark, 91% of the population have computers and 97 out of 100 families have internet access, indicating that lack of access to technology is not the primary reason for nonuse. Although previous studies have primarily focused on participants' perspectives of using internet-based treatment for alcohol use disorder (AUD), no study has investigated individuals’ reasons to prefer face-to-face treatment over blended face-to-face and internet-based cognitive behavioral therapy (bCBT) for AUD among treatment-seeking populations. Objective: The aim of this qualitative study was to investigate the nonuse of bCBT among patients with AUD. Specifically, this study aims to explore patients' reasons for choosing not to receive treatment via this format. Methods: This study was conducted among Danish patients with AUD who were enrolled in the study “Blending internet treatment into conventional face-to-face treatment for alcohol use disorder (Blend-A)” but had not used bCBT. The participant group consisted of 11 patients with AUD: 3 women and 8 men. The age range of the participants was 29-78 years (mean 59 years). Individual semistructured interviews were conducted using cell phones to gather participants’ reasons for not choosing bCBT. The interviews were recorded, transcribed, and analyzed using thematic analysis. Five authors performed the analysis in 3 steps: (1) two authors read the transcripts and coded themes from their immediate impression of the material, (2) one author provided feedback, which was used to group overlapping themes together or create new themes that better reflected the content, and (3) the remaining two authors provided feedback on the analysis to improve its structure, readability, and relevance to the research aim. Results: We found that the participants had various reasons for choosing face-to-face treatment over bCBT; these reasons were more related to personal matters and lesser to digital health literacy. We identified 4 themes related to personal matters for choosing face-to-face treatment over bCBT: (1) patients’ need for attending sessions in person, (2) preference for verbal communication, (3) desire for immediate feedback, and (4) feeling more empowered and motivated with face-to-face sessions. Conclusions: This study provides valuable insight into participants’ perspectives on blended therapy for AUD and highlights the importance of considering personal factors when designing digital health interventions. Our study indicates that most of the participants choose not to use bCBT for AUD because they perceive such treatment formats as impersonal. Instead, they prefer direct communication with the therapist, including the ability to express and comprehend facial expressions and body language. International Registered Report Identifier (IRRID): RR2-10.1186/s12888-021-03122-4 %M 38349711 %R 10.2196/45471 %U https://formative.jmir.org/2024/1/e45471 %U https://doi.org/10.2196/45471 %U http://www.ncbi.nlm.nih.gov/pubmed/38349711 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e44111 %T Evaluating the Intensity of Exposure to MTV Shuga, an Edutainment Program for HIV Prevention: Cross-Sectional Study in Eastern Cape, South Africa %A Mulwa,Sarah %A Baker,Venetia %A Cawood,Cherie %A Khanyile,David %A O'Donnell,Dominique %A Sarrassat,Sophie %A Cousens,Simon %A Birdthistle,Isolde %+ Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, United Kingdom, 44 20 7636 863, sarah.mulwa@lshtm.ac.uk %K young people %K media %K evaluation %K dose-response %K edutainment %K HIV prevention %K mobile phone %D 2024 %7 13.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: MTV Shuga is an edutainment campaign designed to equip young people with knowledge, motivation, and informed choices to protect themselves from HIV infection. From 2019 to 2020, a total of 10 episodes of a new dramatic series, MTV Shuga “Down South 2” (DS2), were broadcast via television and the internet, alongside complementary media activities. Objective: This study aims to investigate whether the intensity of DS2 exposure was linked with positive HIV prevention outcomes in a setting with high HIV prevalence and relatively low levels of HIV testing. Methods: We analyzed data from a web-based survey of participants aged 15 to 24 years in South Africa in 2020. The survey was promoted via social media platforms of schools, universities, and communities in Eastern Cape, South Africa. The primary exposure of interest was the intensity of exposure to DS2, measured by the number of episodes of DS2 watched on the television or the internet or listened to on the radio (out of 10 episodes). Individuals who had not watched or listened to any DS2 episode were classified according to other MTV Shuga content that they had accessed. We estimated associations between the intensity of DS2 exposure and HIV-related outcomes, including knowledge of HIV status, awareness of HIV self-testing (HIVST) and pre-exposure prophylaxis (PrEP), uptake of HIVST, and demand for HIVST and PrEP, adjusting for potential confounders using multivariable logistic regression. Results: Among the 3431 survey participants, 827 (24.1%) were exposed to DS2. Specifically, 18.1% (622/3431) watched or listened to only 1 DS2 episode, and 2.4% (82/3431), 1.7% (58/3431), and 1.8% (62/3431) watched or listened to 2 to 4, 5 to 7, and 8 to 10 DS2 episodes, respectively. Increasing the exposure to DS2 was associated with improvements in most outcomes. Exposure to multiple episodes (eg, 2-4, 5-7, and 8-10) was associated with successively higher odds of knowing one’s HIV status, awareness of PrEP and HIVST, and uptake of HIVST compared with no MTV Shuga exposure, albeit with statistical uncertainty around some estimates. The interest in using HIVST or PrEP was high overall (>80%), with no measurable differences by DS2 intensity. Conclusions: We found evidence consistent with a dose-response relationship between MTV Shuga DS2 exposure and outcomes, including knowledge of HIV status, awareness and uptake of HIVST, and awareness of PrEP among young people in Eastern Cape. This indicates that greater engagement with a youth-focused edutainment campaign can improve HIV testing and prevention options in a setting and population with high need. However, only a few participants accessed multiple DS2 episodes despite its availability on multiple media platforms. We conclude that there is potential to benefit more young people by increasing access to and interest in the show. %M 38349729 %R 10.2196/44111 %U https://formative.jmir.org/2024/1/e44111 %U https://doi.org/10.2196/44111 %U http://www.ncbi.nlm.nih.gov/pubmed/38349729 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55081 %T Digital Knowledge Translation Tools for Disseminating Sexual and Reproductive Health Information to Adolescents: Protocol for an Evidence Gap Map Review %A Meherali,Salima %A Bhaumik,Soumyadeep %A Idrees,Sobia %A Kennedy,Megan %A Lassi,Zohra S %+ Faculty of Nursing, College of Health Sciences, University of Alberta, 5-021 Edmonton Clinic Health Academy, 11405 – 87 Avenue, Edmonton, AB, T6G 1C9, Canada, 1 7806559335, sidrees@ualberta.ca %K adolescents %K sexual and reproductive health %K digital tools %K knowledge translation %K mobile phone %D 2024 %7 13.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Digital or eHealth knowledge translation (KT) interventions have been identified as useful public health tools, particularly to advance sexual and reproductive health (SRH) among adolescents. Existing literature reviews on digital health interventions for adolescents’ SRH demonstrate limitations, including shortcomings in reporting and comprehensiveness that limit the utility and trustworthiness of findings. However, there is a lack of evidence synthesis on the effectiveness of available digital or mobile health KT tools to promote SRH interventions for adolescents. Objective: We aim to identify, map, and describe existing empirical evidence on the digital KT tools developed to improve adolescent SRH outcomes globally. Methods: This study will be conducted using an evidence gap map (EGM) approach to address the objectives, including reviewing relevant literature and a landscape analysis of the outcomes of interest. The following electronic databases will be searched for retrieval of literature: MEDLINE (1946-present), Embase (1974-present), and Global Health (1910-present) via OVID; CINAHL (1936-present) via EBSCOhost; Scopus (1976-present); and Cochrane Library (1993-present) via Wiley. We will include only those studies that focused on adolescents aged 10-19 years and addressed SRH outcomes. We will include experimental studies (randomized or cluster randomized and nonrandomized controlled trials, including quasi-randomized, controlled before-after, and interruptive time series) and observational studies, that is, including prospective cohort and case-control studies. The experimental and observational studies will only be included in the presence of control or comparison arms. Studies with a historical control arm will be excluded. The systematic review software, Covidence (Ventas Health Innovation), will be used to screen and select the studies. Further, 2 independent reviewers will complete the first and second levels of screening of studies and any conflicts arising will be resolved by consensus between the 2 reviewers or by involving the third reviewer. We will conduct the quality assessment of all included studies using the Risk of Bias tool for randomized controlled trials and nonrandomized controlled trials, and AMSTAR2 for systematic reviews. Results: Papers screening, data extraction, and synthesis will be completed by March 2024. We will use EPPI-Mapper (The International Public Policy Observatory) software to generate an online evidence map and to produce the tables and figures for the descriptive report. This EGM review will identify areas with high-quality, evidence-based digital KT tools (for immediate scale and spread) and areas where few or no KT tools exist (for targeted KT tool development and research or policy prioritization). Conclusions: This protocol focused on mapping eHealth KT tools that have been used in the literature to address SRH among adolescents. This will be the first EGM exercise to map digital KT tools to promote adolescents’ SRH and will incorporate a range of published sources. International Registered Report Identifier (IRRID): DERR1-10.2196/55081 %M 38349722 %R 10.2196/55081 %U https://www.researchprotocols.org/2024/1/e55081 %U https://doi.org/10.2196/55081 %U http://www.ncbi.nlm.nih.gov/pubmed/38349722 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54707 %T Supporting Life Adjustment in Patients With Lung Cancer Through a Comprehensive Care Program: Protocol for a Controlled Before-and-After Trial %A Jung,Wonyoung %A Ahn,Alice %A Lee,Genehee %A Kong,Sunga %A Kang,Danbee %A Lee,Dongok %A Kim,Tae Eun %A Shim,Young Mog %A Kim,Hong Kwan %A Cho,Jongho %A Cho,Juhee %A Shin,Dong Wook %+ Department of Family Medicine and Supportive Care Center, Samsung Medical Center, Sungkyunkwan University, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea, 82 2 3410 5252, dwshin.md@gmail.com %K comprehensive care %K early intervention %K adjustment to cancer %K return to work %K lung cancer %K unmet needs %K lung %K lungs %K pulmonary %K respiratory %K cancer %K oncology %K prehabilitation %K survivor %K survivors %K survivorship %K education %K educational %D 2024 %7 13.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Lung cancer diagnosis affects an individual’s quality of life as well as physical and emotional functioning. Information on survivorship care tends to be introduced at the end of treatment, but early intervention may affect posttreatment adjustment. However, to the best of our knowledge, no study has explored the effect of early information intervention on the return to work, family, and societal roles of lung cancer survivors. Objective: We report the study protocol of a comprehensive care prehabilitation intervention designed to facilitate lung cancer survivors’ psychological adjustment after treatment. Methods: A comprehensive care program was developed based on a literature review and a qualitative study of patients with lung cancer and health professionals. The Lung Cancer Comprehensive Care Program consists of educational videos and follow-up visits by a family medicine physician. To prevent contamination, the control group received routine education, whereas the intervention group received routine care and intervention. Both groups completed questionnaires before surgery (T0) and at 1-month (T1), 6-month (T2), and 1-year (T3) follow-up visits after surgery. The primary outcome was survivors’ psychological adjustment to cancer 6 months after pulmonary resection. Results: The historical control group (n=441) was recruited from September 8, 2021, to April 20, 2022, and the intervention group (n=350) was recruited from April 22, 2022, to October 17, 2022. All statistical analyses will be performed upon completion of the study. Conclusions: This study examined the effectiveness of an intervention that provided general and tailored informational support to lung cancer survivors, ranging from before to the end of treatment. Trial Registration: ClinicalTrials.gov NCT05078918; https://clinicaltrials.gov/ct2/show/NCT05078918 International Registered Report Identifier (IRRID): DERR1-10.2196/54707 %M 38349712 %R 10.2196/54707 %U https://www.researchprotocols.org/2024/1/e54707 %U https://doi.org/10.2196/54707 %U http://www.ncbi.nlm.nih.gov/pubmed/38349712 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e55930 %T Authors' Reply: Concerns About the Generalizability Associated With a South African Randomized Controlled Trial on Prenatal Mothers %A Adam,Maya %A Nguyễn,Vān Kính %+ Department of Pediatrics, Stanford University School of Medicine, 291 Campus Drive, Stanford, CA, 94305, United States, 1 6508393600, madam@stanford.edu %K maternal child health %K mHealth %K mobile health %K randomized controlled trial %K short animated storytelling %K South Africa %K video health messaging %D 2024 %7 12.2.2024 %9 Letter to the Editor %J J Med Internet Res %G English %X %M 38345840 %R 10.2196/55930 %U https://www.jmir.org/2024/1/e55930 %U https://doi.org/10.2196/55930 %U http://www.ncbi.nlm.nih.gov/pubmed/38345840 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53861 %T Concerns About the Generalizability Associated With a South African Randomized Controlled Trial on Prenatal Mothers %A Lin,Yongjian %+ Department of Gastrointestinal and Gland Surgery, The First Affiliated Hospital of Guangxi Medical University, No. 22, Shuangyou Road, Qingxiu District, Nanning, 530021, China, 86 13878870525, linyongjian@stu.gxmu.edu.cn %K letter %K maternal child health %K mHealth %K mobile health %K randomized controlled trial %K short animated storytelling %K South Africa %K video health messaging %D 2024 %7 12.2.2024 %9 Letter to the Editor %J J Med Internet Res %G English %X %M 38345847 %R 10.2196/53861 %U https://www.jmir.org/2024/1/e53861 %U https://doi.org/10.2196/53861 %U http://www.ncbi.nlm.nih.gov/pubmed/38345847 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e47745 %T Mobile Mindfulness Meditation for Cancer-Related Anxiety and Neuropathy: Protocol for a Randomized Controlled Trial %A Orasud,Ariel Siritorn %A Uchiyama,Mai %A Pagano,Ian %A Bantum,Erin %+ Cancer Prevention in the Pacific, University of Hawai’i Cancer Center, 701 Ilalo St, B4, Honolulu, HI, 96813, United States, 1 8083493621, ebantum@cc.hawaii.edu %K cancer %K cancer survivorship %K mindfulness meditation %K mHealth %K well-being %K quality of life %K mobile health %K coaching %K coach %K mindfulness %K meditation %K survivor %K survivorship %K oncology %K mental health %K anxiety %K neuropathy %K survivors %K RCT %K randomized %K clinical trial %K clinical trials %D 2024 %7 12.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Anxiety- and cancer-related neuropathy are two persistent effects related to treatment for cancer. Mindfulness meditation has been used with substantial impact as a nonpharmacologic intervention to mitigate side and late effects of treatment. Mobile apps are ubiquitous for most of the general population, yet have a particular relevance for cancer survivors, given that physical and geographic limitations can be present. Objective: This study aims to describe an ongoing trial of the Mindfulness Coach mobile app for cancer survivors. Methods: In this randomized waitlist controlled trial, cancer survivors experiencing anxiety- or cancer-related neuropathy (200 for neuropathy and 200 for anxiety) and who had finished primary cancer treatment were invited to participate. Data were collected at 3 time points regardless of randomization condition: baseline, 8 weeks, and 16 weeks. Both face-to-face and web-based recruitment strategies were used. The trial was opened for 2 separate primary outcomes (anxiety- or cancer-related neuropathy). The goal was not to compare these groups but to compare treatment and waitlist groups for each condition. In addition to evaluating the impact of mobile mindfulness on reported anxiety- or cancer-related neuropathy, other pain, fatigue, trauma, sleep, and satisfaction with the Mindfulness Coach app will also be assessed. Results: Outcomes of the study are expected in early 2024. Conclusions: Mindfulness meditation has become widely practiced, and the use of mobile technology has become ubiquitous. Finding ways to deliver mindfulness meditation to people who have been treated for cancer allows for the intervention to be accessible to a larger number of survivors. The results of this intervention could have implications for further understanding the impact of mindfulness meditation on 2 persistent side and late effects of treatment of cancer, namely anxiety- and cancer-related neuropathy. Trial Registration: ClinicalTrials.gov NCT03581357; https://ClinicalTrials.gov/study/NCT03581357 International Registered Report Identifier (IRRID): DERR1-10.2196/47745 %M 38345843 %R 10.2196/47745 %U https://www.researchprotocols.org/2024/1/e47745 %U https://doi.org/10.2196/47745 %U http://www.ncbi.nlm.nih.gov/pubmed/38345843 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53372 %T Web-Based Health Information Seeking by People Living With Multiple Sclerosis: Qualitative Investigation of the Multiple Sclerosis Online Course %A Bevens,William %A Davenport,Rebekah %A Neate,Sandra %A Yu,Maggie %A Jelinek,Pia %A Jelinek,George Alexander %A Reece,Jeanette %+ Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, 335 Bouverie Street, Carlton, 3053, Australia, 61 3 8344 2173, wbevens@hs.uci.edu %K information-seeking behavior %K self-management %K lifestyle %K digital health %D 2024 %7 9.2.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital technologies have afforded people living with multiple sclerosis (MS) access to telehealth consultations, diagnostic tools, and monitoring. Although health care professionals remain the most trusted source of information, the internet has emerged as a valuable resource for providing MS-related information, particularly during the COVID-19 pandemic. Notably, people living with MS are increasingly seeking educational content for a range of topics related to the self-management of MS; however, web-based information seeking remains largely underevaluated. To address this gap and ensure that web-based health-related information is accessible and engaging, this study used qualitative methods to analyze the reflections from participants of web-based educational programs for people living with MS. Objective: This study aimed to explore the motivations, behaviors, and expectations of web-based health information seeking for people living with MS. Methods: We conducted semistructured interviews for 38 people living with MS 1 month after they completed the novel MS Online Course, which provided information on modifiable lifestyle-related risk factors for people living with MS. Of the 38 participants, 22 (58%) completed the intervention course and 16 (42%) completed the standard care course. Inductive thematic analysis was used within a qualitative paradigm, and 2 authors coded each interview separately and arrived at themes with consensus. Results: We identified 2 themes: motivation to learn and MS information on the web. The diagnosis of MS was described as a pivotal moment for precipitating web-based information seeking. People living with MS sought lifestyle-related information to facilitate self-management and increase control of their MS. Although social media sites and MS websites were considered useful for providing both support and information, discretion was needed to critically appraise information. Recognizable institutions were frequently accessed because of their trustworthiness. Conclusions: This study provided novel insights into the motivations of people living with MS for seeking web-based health information. Furthermore, their preferences for the content and format of the web-based information accessed and their experiences and reactions to this information were explored. These findings may guide educators, researchers, and clinicians involved in MS care to optimize the engagement and processing of web-based health information seeking by people living with MS. %M 38335016 %R 10.2196/53372 %U https://www.jmir.org/2024/1/e53372 %U https://doi.org/10.2196/53372 %U http://www.ncbi.nlm.nih.gov/pubmed/38335016 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e51057 %T Reflective Engagement With a Digital Physical Activity Intervention Among People Living With and Beyond Breast Cancer: Mixed Methods Study %A Robertson,Michael C %A Cox-Martin,Emily %A Basen-Engquist,Karen %A Lyons,Elizabeth J %+ Department of Family and Preventive Medicine, TSET Health Promotion Research Center, University of Oklahoma Health Sciences Center, 655 Research Pkwy #400, Oklahoma City, OK, 73104, United States, 1 405 271 6872, michael-robertson@ouhsc.edu %K survivors of cancer %K exercise %K acceptance and commitment therapy %K fatigue %K mindfulness %K motivation %K behavioral sciences %D 2024 %7 9.2.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: People living with and beyond breast cancer can face internal barriers to physical activity (eg, fatigue and pain). Digital interventions that promote psychological acceptance and motivation may help this population navigate these barriers. The degree to which individuals (1) adhere to intervention protocols and (2) reflect on and internalize intervention content may predict intervention efficacy. Objective: The objective of this study was to characterize the nature of reflective processes brought about by an 8-week acceptance- and mindfulness-based physical activity intervention for insufficiently active survivors of breast cancer (n=75). Furthermore, we explored the potential utility of a metric of reflective processes for predicting study outcomes. Methods: Of the intervention’s 8 weekly modules, 7 (88%) included an item that asked participants to reflect on what they found to be most useful. Two coders conducted directed content analysis on participants’ written responses. They assessed each comment’s depth of reflection using an existing framework (ranging from 0 to 4, with 0=simple description and 4=fundamental change with consideration of social and ethical issues). The coders identified themes within the various levels of reflection. We fit multiple linear regression models to evaluate whether participants’ (1) intervention adherence (ie, number of modules completed) and (2) the mean level of the depth of reflection predicted study outcomes. Results: Participants were aged on average 57.2 (SD 11.2) years, mostly non-Hispanic White (58/75, 77%), and mostly overweight or obese (54/75, 72%). Of the 407 responses to the item prompting personal reflection, 70 (17.2%) were rated as reflection level 0 (ie, description), 247 (60.7%) were level 1 (ie, reflective description), 74 (18.2%) were level 2 (ie, dialogic reflection), 14 (3.4%) were level 3 (ie, transformative reflection), and 2 (0.5%) were level 4 (ie, critical reflection). Lower levels of reflection were characterized by the acquisition of knowledge or expressing intentions. Higher levels were characterized by personal insight, commentary on behavior change processes, and a change of perspective. Intervention adherence was associated with increases in self-reported weekly bouts of muscle-strengthening exercise (B=0.26, SE 0.12, 95% CI 0.02-0.50) and decreases in sleep disturbance (B=−1.04, SE 0.50, 95% CI −0.06 to −2.02). The mean level of reflection was associated with increases in psychological acceptance (B=3.42, SE 1.70, 95% CI 0.09-6.75) and motivation for physical activity (ie, integrated regulation: B=0.55, SE 0.25, 95% CI 0.06-1.04). Conclusions: We identified a useful method for understanding the reflective processes that can occur during digital behavior change interventions serving people living with and beyond breast cancer. Intervention adherence and the depth of reflection each predicted changes in study outcomes. Deeper reflection on intervention content was associated with beneficial changes in the determinants of sustained behavior change. More research is needed to investigate the relations among digital behavior change intervention use, psychological processes, and intervention efficacy. %M 38335025 %R 10.2196/51057 %U https://mhealth.jmir.org/2024/1/e51057 %U https://doi.org/10.2196/51057 %U http://www.ncbi.nlm.nih.gov/pubmed/38335025 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e51704 %T Incorporating a Stepped Care Approach Into Internet-Based Cognitive Behavioral Therapy for Depression: Randomized Controlled Trial %A Jagayat,Jasleen Kaur %A Kumar,Anchan %A Shao,Yijia %A Pannu,Amrita %A Patel,Charmy %A Shirazi,Amirhossein %A Omrani,Mohsen %A Alavi,Nazanin %+ Centre for Neuroscience Studies, Queen's University, 18 Stuart Street, Kingston, ON, K7L 3N6, Canada, 1 613 533 2600, jasleenjagayat@gmail.com %K internet-based cognitive behavioral therapy %K i-CBT %K major depressive disorder %K MDD %K stepped care %K digital mental health care %K mobile phone %D 2024 %7 9.2.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Depression is a hidden burden, yet it is a leading cause of disability worldwide. Despite the adverse effects of depression, fewer than one-third of patients receive care. Internet-based cognitive behavioral therapy (i-CBT) is an effective treatment for depression, and combining i-CBT with supervised care could make the therapy scalable and effective. A stepped care model is a framework for beginning treatment with an effective and low-intensity intervention while adapting care based on the patient’s needs. Objective: This study investigated the efficacy of a stepped care i-CBT model for depression based on changes in self-reported depressive symptoms. Methods: In this single-blinded, randomized controlled trial, participants were allocated to either the i-CBT–only group (28/56, 50%) or the i-CBT with stepped care group (28/56, 50%). Both groups received a 13-week i-CBT program tailored for depression. The i-CBT program was provided through a secure, online mental health clinic called the Online Psychotherapy Tool. Participants read through the sessions and completed the assignments related to each session. Participants in the stepped care group received additional interventions from their care provider based on standard questionnaire scores (ie, Patient Health Questionnaire–9 [PHQ-9], Quick Inventory of Depressive Symptomatology [QIDS], and Quality of Life Enjoyment and Satisfaction Questionnaire–Short Form) and their assignment responses. From lowest to highest intensity, the additional interventions included SMS text messages, phone calls, video calls, or a video call with a psychiatrist. Results: For this study, 56 participants were recruited to complete an i-CBT program (n=28, 50%; mean age 37.9; SD 13.08 y; 7/28, 27% were men) or an i-CBT with stepped care program (n=28, 50%; mean age 40.6; SD 14.28 y; 11/28, 42% were men). The results of this study indicate that the i-CBT program was effective in significantly reducing depressive symptoms, as measured by the PHQ-9 (F4,80=9.95; P<.001) and QIDS (F2,28=5.73; P=.008); however, there were no significant differences in the reduction of depressive symptoms between the 2 groups (PHQ-9: F4,80=0.43; P=.78; QIDS: F2,28=3.05; P=.06). The stepped care group was not significantly better in reducing depressive symptoms than the i-CBT group (PHQ-9, P=.79; QIDS, P=.06). Although there were no significant differences observed between the number of participants who completed the program between the groups (χ21=2.6; P=.10), participants in the stepped care group, on average, participated in more sessions than those who prematurely terminated participation in the i-CBT group (t55=−2; P=.03; 95% CI –4.83 to –0.002). Conclusions: Implementing a stepped care approach in i-CBT is an effective treatment for depression, and the stepped care model can assist patients to complete more sessions in their treatment. Trial Registration: Clinicaltrials.gov NCT04747873; https://clinicaltrials.gov/study/NCT04747873 %M 38173167 %R 10.2196/51704 %U https://mental.jmir.org/2024/1/e51704 %U https://doi.org/10.2196/51704 %U http://www.ncbi.nlm.nih.gov/pubmed/38173167 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e51225 %T The Impact of Intervention Design on User Engagement in Digital Therapeutics Research: Factorial Experiment With a Mixed Methods Study %A Lee,Hyerim %A Choi,Eung Ho %A Shin,Jung U %A Kim,Tae-Gyun %A Oh,Jooyoung %A Shin,Bokyoung %A Sim,Jung Yeon %A Shin,Jaeyong %A Kim,Meelim %+ Herbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, Atkinson Hall, 9500 Gilman Dr, La Jolla, San Diego, CA, 92121, United States, 1 323 776 5171, mek007@health.ucsd.edu %K atopic %K dermatitis %K experimental design %K mobile health %K patient engagement %K research methodology %D 2024 %7 9.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: User engagement is crucial for digital therapeutics (DTx) effectiveness; due to variations in the conceptualization of engagement and intervention design, assessment and retention of engagement remain challenging. Objective: We investigated the influence of the perceived acceptability of experimental intervention components and satisfaction with core intervention components in DTx on user engagement, while also identifying potential barriers and facilitators to user engagement. Methods: We conducted a mixed methods study with a 2 × 2 factorial design, involving 12 outpatients with atopic dermatitis. Participants were randomized into 4 experimental groups based on push notification (“basic” or “advanced”) and human coach (“on” or “off”) experimental intervention components. All participants engaged in self-monitoring and learning courses as core intervention components within an app-based intervention over 8 weeks. Data were collected through in-app behavioral data, physician- and self-reported questionnaires, and semistructured interviews assessed at baseline, 4 weeks, and 8 weeks. Descriptive statistics and thematic analysis were used to evaluate user engagement, perceived acceptability of experimental intervention components (ie, push notification and human coach), satisfaction with core intervention components (ie, self-monitoring and learning courses), and intervention effectiveness through clinical outcomes. Results: The primary outcome indicated that group 4, provided with “advanced-level push notifications” and a “human coach,” showed higher completion rates for self-monitoring forms and learning courses compared to the predetermined threshold of clinical significance. Qualitative data analysis revealed three key themes: (1) perceived acceptability of the experimental intervention components, (2) satisfaction with the core intervention components, and (3) suggestions for improvement in the overall intervention program. Regarding clinical outcomes, the Perceived Stress Scale and Dermatology Life Quality Index scores presented the highest improvement in group 4. Conclusions: These findings will help refine the intervention and inform the design of a subsequent randomized trial to test its effectiveness. Furthermore, this design may serve as a model for broadly examining and optimizing overall engagement in DTx and for future investigation into the complex relationship between engagement and clinical outcomes. Trial Registration: Clinical Research Information Service KCT0007675; http://tinyurl.com/2m8rjrmv %M 38335015 %R 10.2196/51225 %U https://formative.jmir.org/2024/1/e51225 %U https://doi.org/10.2196/51225 %U http://www.ncbi.nlm.nih.gov/pubmed/38335015 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e47555 %T Investigation of the Impact of Wellinks on the Quality of Life and Clinical Outcomes in Patients With Chronic Obstructive Pulmonary Disease: Interventional Research Study %A Pierz,Kerri A %A Locantore,Nicholas %A McCreary,Gretchen %A Calvey,Robert J %A Hackney,Nickole %A Doshi,Pooja %A Linnell,John %A Sundaramoorthy,Abirammy %A Reed,Carol R %A Yates,Julie %+ Wellinks (Convexity Scientific, Inc), 85 Willow Street, New Haven, CT, 06511, United States, 1 203 240 5619, kerri.pierz@wellinks.com %K chronic obstructive pulmonary disease %K COPD %K health coaching %K pulmonary rehabilitation %K remote care %K disease management %K patient engagement %K Wellinks %K digital health %K adult %K mobile app %K remote model of care %K mobile phone %D 2024 %7 9.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Wellinks is a remote disease management solution that provides novel chronic obstructive pulmonary disease (COPD) care delivery. Objective: This study evaluated the satisfaction, engagement, and clinical outcomes of Wellinks participants. This study also investigated the cadence of health coaching for patients with COPD. Methods: A 24-week interventional study was conducted by Wellinks and the COPD Foundation in 2022. Adults with COPD were recruited by the COPD Foundation in the United States and determined to be eligible if they had phone and internet access, owned a smartphone, and were not currently participating in pulmonary rehabilitation. All study participants provided written informed consent. The Wellinks solution included remote health coaching, pulmonary rehabilitation, and group education; participants were provided the Wellinks app and smart spirometry and pulse oximetry devices. Participants were offered 6 coaching sessions in the first 12 weeks. For the second 12-week period, participants either reduced frequency or discontinued coaching; all other components of the Wellinks solution remained unchanged. The COPD Self-Efficacy Scale, Modified Medical Research Council dyspnea scale, pulmonary function, pulse oximetry, and patient-reported healthcare resource utilization were the clinical outcome measures. Nonclinical outcomes included engagement and satisfaction with Wellinks and net promoter score. Results: In total, 141 adults consented and completed Wellinks onboarding; 84.4% (n=119) of whom remained engaged throughout the 24-week study. Participants had a mean age of 70 (SD 7.8; range 48-88) years, and 55.7% (n=78) were female. Most participants (n=119, 84.4%) completed all 6 coaching sessions during the first 12-week period. Compliance with spirometer and pulse oximeter use was 82.3% and 89.4%, respectively, at week 1 but waned over the study period to 8.5% and 9.2%, respectively, at the end of the study. Participants indicated a high degree of satisfaction with Wellinks, with 95.5% (n=85) and 91% (n=81) of participants indicating that they agreed or strongly agreed that the educational content and health coaching, respectively, were valuable. At the end of the study, the net promoter score was +64 and +55 in the coaching continuation and discontinuation arms, respectively. A significant improvement from baseline to end of the study was observed in the COPD Self-Efficacy Scale total score (P<.001) and domain scores (P<.001 for each domain). In total, 35.1% (n=27) of participants improved by at least 1 category of change on the 5-point Modified Medical Research Council dyspnea scale from baseline to week 24. Conclusions: This study confirmed the feasibility of using a remote model of care delivery to support people living with COPD. The insights gained in this study have allowed for further refinement and personalization of the Wellinks care model. Findings related to the combined use of technology and personal care delivery should be considered by others developing remote disease management tools. Trial Registration: ClinicalTrials.gov NCT05259280; https://clinicaltrials.gov/ct2/show/NCT05259280 %M 38335023 %R 10.2196/47555 %U https://formative.jmir.org/2024/1/e47555 %U https://doi.org/10.2196/47555 %U http://www.ncbi.nlm.nih.gov/pubmed/38335023 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e50340 %T The Effectiveness of Digital Health Lifestyle Interventions on People With Prediabetes: Protocol for a Systematic Review, Meta-Analysis, and Meta-Regression %A Holm,Tanja Fredensborg %A Udsen,Flemming Witt %A Færch,Kristine %A Jensen,Morten Hasselstrøm %A von Scholten,Bernt Johan %A Hejlesen,Ole Kristian %A Hangaard,Stine %+ Department of Health Science and Technology, Aalborg University, Selma Lagerløfs vej 249, Gistrup, 9260, Denmark, 45 23459792, tfh@hst.aau.dk %K digital health %K effectiveness %K lifestyle intervention %K meta-analysis %K meta-regression %K prediabetic state %K systematic review %K type 2 diabetes prevention %K weight loss %D 2024 %7 9.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: There has been an increasing interest in the use of digital health lifestyle interventions for people with prediabetes, as these interventions may offer a scalable approach to preventing type 2 diabetes. Previous systematic reviews on digital health lifestyle interventions for people with prediabetes had limitations, such as a narrow focus on certain types of interventions, a lack of statistical pooling, and no broader subgroup analysis of intervention characteristics. The identified limitations observed in previous systematic reviews substantiate the necessity of conducting a comprehensive review to address these gaps within the field. This will enable a comprehensive understanding of the effectiveness of digital health lifestyle interventions for people with prediabetes. Objective: The objective of this systematic review, meta-analysis, and meta-regression is to systematically investigate the effectiveness of digital health lifestyle interventions on prediabetes-related outcomes in comparison with any comparator without a digital component among adults with prediabetes. Methods: This systematic review will include randomized controlled trials that investigate the effectiveness of digital health lifestyle interventions on adults (aged 18 years or older) with prediabetes and compare the digital interventions with nondigital interventions. The primary outcome will be change in body weight (kg). Secondary outcomes include, among others, change in glycemic status, markers of cardiometabolic health, feasibility outcomes, and incidence of type 2 diabetes. Embase, PubMed, CINAHL, and CENTRAL (Cochrane Central Register of Controlled Trials) will be systematically searched. The data items to be extracted include study characteristics, participant characteristics, intervention characteristics, and relevant outcomes. To estimate the overall effect size, a meta-analysis will be conducted using the mean difference. Additionally, if feasible, meta-regression on study, intervention, and participant characteristics will be performed. The Cochrane risk of bias tool will be applied to assess study quality, and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach will be used to assess the certainty of evidence. Results: The results are projected to yield an overall estimate of the effectiveness of digital health lifestyle interventions on adults with prediabetes and elucidate the characteristics that contribute to their effectiveness. Conclusions: The insights gained from this study may help clarify the potential of digital health lifestyle interventions for people with prediabetes and guide the decision-making regarding future intervention components. Trial Registration: PROSPERO CRD42023426919; http://tinyurl.com/d3enrw9j International Registered Report Identifier (IRRID): PRR1-10.2196/50340 %M 38335018 %R 10.2196/50340 %U https://www.researchprotocols.org/2024/1/e50340 %U https://doi.org/10.2196/50340 %U http://www.ncbi.nlm.nih.gov/pubmed/38335018 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e47360 %T Exploring User Perspectives on Brief Reflective Questioning Activities for Stress Management: Mixed Methods Study %A Bhattacharjee,Ananya %A Chen,Pan %A Mandal,Abhijoy %A Hsu,Anne %A O'Leary,Katie %A Mariakakis,Alex %A Williams,Joseph Jay %+ Department of Computer Science, University of Toronto, 40 St George St, Toronto, ON, M5S 2E4, Canada, 1 647 619 6982, ananya@cs.toronto.edu %K reflection %K mental health %K stress %K reflective questioning activity %K RQA %K brief intervention %K computer-mediated communication %K email %K SMS text messaging %K mobile phone %D 2024 %7 8.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Current online interventions dedicated to assisting individuals in managing stress and negative emotions often necessitate substantial time commitments. This can be burdensome for users, leading to high dropout rates and reducing the effectiveness of these interventions. This highlights an urgent need for concise digital activities that individuals can swiftly access during instances of negative emotions or stress in their daily lives. Objective: The primary aim of this study was to investigate the viability of using a brief digital exercise, specifically a reflective questioning activity (RQA), to help people reflect on their thoughts and emotions about a troubling situation. The RQA is designed to be quick, applicable to the general public, and scalable without requiring a significant support structure. Methods: We conducted 3 simultaneous studies. In the first study, we recruited 48 participants who completed the RQA and provided qualitative feedback on its design through surveys and semistructured interviews. In the second study, which involved 215 participants from Amazon Mechanical Turk, we used a between-participants design to compare the RQA with a single-question activity. Our hypotheses posited that the RQA would yield greater immediate stress relief and higher perceived utility, while not significantly altering the perception of time commitment. To assess these, we measured survey completion times and gathered multiple self-reported scores. In the third study, we assessed the RQA’s real-world impact as a periodic intervention, exploring engagement via platforms such as email and SMS text messaging, complemented by follow-up interviews with participants. Results: In our first study, participants appreciated the RQA for facilitating structured reflection, enabling expression through writing, and promoting problem-solving. However, some of the participants experienced confusion and frustration, particularly when they were unable to find solutions or alternative perspectives on their thoughts. In the second study, the RQA condition resulted in significantly higher ratings (P=.003) for the utility of the activity and a statistically significant decrease (P<.001) in perceived stress rating compared with the single-question activity. Although the RQA required significantly more time to be completed (P<.001), there was no statistically significant difference in participants’ subjective perceived time commitment (P=.37). Deploying the RQA over 2 weeks in the third study identified some potential challenges to consider for such activities, such as the monotony of doing the same activity several times, the limited affordances of mobile phones, and the importance of having the prompts align with the occurrence of new troubling situations. Conclusions: This paper describes the design and evaluation of a brief online self-reflection activity based on cognitive behavioral therapy principles. Our findings can inform practitioners and researchers in the design and exploration of formats for brief interventions to help people with everyday struggles. %M 38329800 %R 10.2196/47360 %U https://formative.jmir.org/2024/1/e47360 %U https://doi.org/10.2196/47360 %U http://www.ncbi.nlm.nih.gov/pubmed/38329800 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e38891 %T A Digitally Enabled Combined Lifestyle Intervention for Weight Loss: Pilot Study in a Dutch General Population Cohort %A Gannamani,Rahul %A Castela Forte,José %A Folkertsma,Pytrik %A Hermans,Sven %A Kumaraswamy,Sridhar %A van Dam,Sipko %A Chavannes,Niels %A van Os,Hendrikus %A Pijl,Hanno %A Wolffenbuttel,Bruce H R %+ Ancora Health BV, Hereplein 34, Groningen, 9711LM, Netherlands, 31 628218360, jose@ancora.health %K lifestyle intervention %K prevention %K obesity %K overweight %K weight loss %K digital health %K intervention %K weight %K pilot %K digital %K data %K Fogg Behavior Model %D 2024 %7 8.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Overweight and obesity rates among the general population of the Netherlands keep increasing. Combined lifestyle interventions (CLIs) focused on physical activity, nutrition, sleep, and stress management can be effective in reducing weight and improving health behaviors. Currently available CLIs for weight loss (CLI-WLs) in the Netherlands consist of face-to-face and community-based sessions, which face scalability challenges. A digitally enabled CLI-WL with digital and human components may provide a solution for this challenge; however, the feasibility of such an intervention has not yet been assessed in the Netherlands. Objective: The aim of this study was two-fold: (1) to determine how weight and other secondary cardiometabolic outcomes (lipids and blood pressure) change over time in a Dutch population with overweight or obesity and cardiometabolic risk participating in a pilot digitally enabled CLI-WL and (2) to collect feedback from participants to guide the further development of future iterations of the intervention. Methods: Participants followed a 16-week digitally enabled lifestyle coaching program rooted in the Fogg Behavior Model, focused on nutrition, physical activity, and other health behaviors, from January 2020 to December 2021. Participants could access the digital app to register and track health behaviors, weight, and anthropometrics data at any time. We retrospectively analyzed changes in weight, blood pressure, and lipids for remeasured users. Surveys and semistructured interviews were conducted to assess critical positive and improvement points reported by participants and health care professionals. Results: Of the 420 participants evaluated at baseline, 53 participated in the pilot. Of these, 37 (70%) were classified as overweight and 16 (30%) had obesity. Mean weight loss of 4.2% occurred at a median of 10 months postintervention. The subpopulation with obesity (n=16) showed a 5.6% weight loss on average. Total cholesterol decreased by 10.2% and low-density lipoprotein cholesterol decreased by 12.9% on average. Systolic and diastolic blood pressure decreased by 3.5% and 7.5%, respectively. Participants identified the possibility of setting clear action plans to work toward and the multiple weekly touch points with coaches as two of the most positive and distinctive components of the digitally enabled intervention. Surveys and interviews demonstrated that the digital implementation of a CLI-WL is feasible and well-received by both participants and health care professionals. Conclusions: Albeit preliminary, these findings suggest that a behavioral lifestyle program with a digital component can achieve greater weight loss than reported for currently available offline CLI-WLs. Thus, a digitally enabled CLI-WL is feasible and may be a scalable alternative to offline CLI-WL programs. Evidence from future studies in a Dutch population may help elucidate the mechanisms behind the effectiveness of a digitally enabled CLI-WL. %M 38329792 %R 10.2196/38891 %U https://formative.jmir.org/2024/1/e38891 %U https://doi.org/10.2196/38891 %U http://www.ncbi.nlm.nih.gov/pubmed/38329792 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53597 %T Digital Phenotyping for Real-Time Monitoring of Nonsuicidal Self-Injury: Protocol for a Prospective Observational Study %A Ahn,Chan-Young %A Lee,Jong-Sun %+ Department of Psychology, Kangwon National University, Kangwondaehak-gil, Chuncheon-si, 24341, Republic of Korea, 82 0332506853, sunny597@gmail.com %K nonsuicidal self-injury %K NSSI %K digital phenotyping %K digital phenotype %K wearable device %K wearable %K wearables %K wrist worn %K mood %K emotion %K emotions %K heart rate %K step %K sleep %K machine learning %K multilevel modeling %K ecological momentary assessment %K EMA %K self-injury %K self-harm %K psychiatry %K psychiatric %K mental health %K predict %K prediction %K predictions %K predictor %K predictors %K predictive %D 2024 %7 8.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Nonsuicidal self-injury (NSSI) is a major global health concern. The limitations of traditional clinical and laboratory-based methodologies are recognized, and there is a pressing need to use novel approaches for the early detection and prevention of NSSI. Unfortunately, there is still a lack of basic knowledge of a descriptive nature on NSSI, including when, how, and why self-injury occurs in everyday life. Digital phenotyping offers the potential to predict and prevent NSSI by assessing objective and ecological measurements at multiple points in time. Objective: This study aims to identify real-time predictors and explain an individual’s dynamic course of NSSI. Methods: This study will use a hybrid approach, combining elements of prospective observational research with non–face-to-face study methods. This study aims to recruit a cohort of 150 adults aged 20 to 29 years who have self-reported engaging in NSSI on 5 or more days within the past year. Participants will be enrolled in a longitudinal study conducted at 3-month intervals, spanning 3 long-term follow-up phases. The ecological momentary assessment (EMA) technique will be used via a smartphone app. Participants will be prompted to complete a self-injury and suicidality questionnaire and a mood appraisal questionnaire 3 times a day for a duration of 14 days. A wrist-worn wearable device will be used to collect heart rate, step count, and sleep patterns from participants. Dynamic structural equation modeling and machine learning approaches will be used. Results: Participant recruitment and data collection started in October 2023. Data collection and analysis are expected to be completed by December 2024. The results will be published in a peer-reviewed journal and presented at scientific conferences. Conclusions: The insights gained from this study will not only shed light on the underlying mechanisms of NSSI but also pave the way for the development of tailored and culturally sensitive treatment options that can effectively address this major mental health concern. International Registered Report Identifier (IRRID): DERR1-10.2196/53597 %M 38329791 %R 10.2196/53597 %U https://www.researchprotocols.org/2024/1/e53597 %U https://doi.org/10.2196/53597 %U http://www.ncbi.nlm.nih.gov/pubmed/38329791 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e48467 %T Preliminary Efficacy of a Digital Intervention for Adolescent Depression: Randomized Controlled Trial %A Peake,Emily %A Miller,Ian %A Flannery,Jessica %A Chen,Lang %A Lake,Jessica %A Padmanabhan,Aarthi %+ Limbix Health Inc, 548 Market St, PMB 91609, San Francisco, CA, 94104, United States, 1 888 546 2495, aarthi.padmanabhan@bighealth.com %K adolescent %K depression %K randomized controlled trial %K mobile phone %K digital therapeutics %K mobile app %K cognitive behavioral therapy %K behavioral activation %K mobile health %D 2024 %7 7.2.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Adolescent depression is a significant public health concern; however, access to effective mental health care is limited. Digital therapeutics (DTx) can improve access to evidence-based interventions; however, their efficacy in adolescents is sparsely documented. Objective: This study aims to examine the efficacy of a mobile app DTx versus an active control as an adjunct treatment for adolescent depression symptoms. Methods: An internet-based open-label randomized control trial was conducted nationwide with a partial crossover design, and 168 adolescents aged 13 to 21 years with symptoms of depression were recruited between November 2020 and September 2021. Participants were randomized (1:1) to the cognitive behavioral therapy–based treatment app (Spark) or to a psychoeducational control app (control), which they would use for a duration of 5 weeks. The primary outcome was a between-group (Spark vs control) difference in the change in depression symptoms from baseline to postintervention, as measured by the Patient Health Questionnaire-8 (PHQ-8) using a linear mixed-effects analysis. The PHQ-8 ranges from 0 to 24, with scores of 5 to 9 indicating mild depression symptoms, scores of 10 to 14 indicating moderate symptoms, scores of 15 to 19 indicating moderately severe symptoms, and scores of 20 to 24 indicating severe symptoms. A minimal clinically important difference (5-point reduction between baseline and postintervention) in the Spark arm and group differences in remission and treatment response rates based on the PHQ-8 at postintervention were also investigated. Results: A total of 160 participants were randomized, 80 in the Spark arm (mean age 16.89, SD 2.5 y) and 80 in the control arm (mean age 16.79, SD 2.59 y). Data from 121 participants (Spark: n=63; control: n=58) with moderate to severe (PHQ-8≥10) symptoms at baseline were included in the primary analyses following a modified intention-to-treat principle. A linear mixed-effect analysis revealed a nonsignificant difference between the study arms in depression symptom change over the intervention period. The Spark arm met a minimal clinically important difference threshold (mean −5.08, 95% CI −6.72 to −3.42). The remission rate in the Spark arm was significantly higher than that in the control arm (11/63, 17% vs 2/58, 3%; χ21=6.2; P=.01; false discovery rate–adjusted P=.03). The treatment response rates were not significantly different between the study arms (P=.07; false discovery rate–adjusted P=.16). Post hoc analyses including participants with mild to severe (PHQ-8 score ≥5) symptoms at baseline revealed promising evidence that Spark is effective in those with mild to severe symptoms. Conclusions: There is initial evidence that a self-guided, cognitive behavioral therapy–based DTx intervention may effectively treat mild to severe depression symptoms in adolescents. DTx may improve access to mental health care for adolescents or serve as an important adjunct to the standard of care. Trial Registration: ClinicalTrials.gov NCT04524598; https://clinicaltrials.gov/study/NCT04524598 %M 38324367 %R 10.2196/48467 %U https://www.jmir.org/2024/1/e48467 %U https://doi.org/10.2196/48467 %U http://www.ncbi.nlm.nih.gov/pubmed/38324367 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e53010 %T Experiences of Older Adults, Physiotherapists, and Aged Care Staff in the TOP UP Telephysiotherapy Program: Interview Study of the TOP UP Interventions %A Dawson,Rik %A Gilchrist,Heidi %A Pinheiro,Marina %A Nelson,Karn %A Bowes,Nina %A Sherrington,Cathie %A Haynes,Abby %+ Institute for Musculoskeletal Health, Sydney Musculoskeletal Health, Sydney Local Health District, The University of Sydney, PO Box M179, Missenden Road, Missenden Road, Camperdown, 2050, Australia, 61 403895186, rik.dawson@sydney.edu.au %K physiotherapy %K telehealth %K telephysiotherapy %K exercise %K aged care %K qualitative methods %K behavior change %K technology %K virtual care %D 2024 %7 7.2.2024 %9 Original Paper %J JMIR Aging %G English %X Background: Telehealth provides opportunities for older adults to access health care. However, limited research exists on the use of telehealth within aged care services, particularly regarding physiotherapy-led fall prevention and mobility programs. Understanding the experiences and interactions of older adults, physiotherapists, and aged care service providers is crucial for the scale-up and sustainability of such essential programs. The TOP UP study, a hybrid type 1 effectiveness-implementation randomized controlled trial in aged care, used a supported multidisciplinary telephysiotherapy model to motivate older adults to engage in exercises to improve mobility and reduce falls. Objective: This qualitative substudy aims to achieve 2 primary objectives: to describe the experiences and acceptability of the TOP UP intervention for older people, physiotherapists, and aged care support workers and managers and to gain an in-depth understanding of program implementation. Methods: A purposive recruitment strategy was used to select 18 older adults who participated in the TOP UP intervention, ensuring variation in age, gender, residential status (home or residential aged care), geographic location, and cognitive levels. In addition, 7 physiotherapists, 8 aged care support workers, and 6 managers from 7 different aged care provider partners participated in this study. Semistructured interviews were conducted to explore stakeholders’ experiences with the TOP UP program, gather suggestions for improvement, and obtain insights for the future implementation of similar telephysiotherapy programs. The interview framework and coding processes were informed by behavior changes and implementation frameworks. Data were analyzed using an abductive approach, informed by 2 behavioral change theories (Capability, Opportunity, Motivation, and Behavior Model and Self-Determination Theory) and the Nonadoption, Abandonment and Challenges to the Scale-Up, Spread and Sustainability of Health and Care Technologies framework. Results: All participants (n=39) reported high levels of acceptability for the TOP UP program and cited multiple perceived benefits. The thematic analysis generated 6 main themes: telephysiotherapy expands opportunity; tailored physiotherapy care with local support enhances motivation; engaging, older adult–friendly educational resources build capability; flexible reablement approach fosters autonomy; telephysiotherapy is safe, effective, and acceptable for many; and organizational commitment is required to embed telehealth. The motivation to exercise was enhanced by Zoom’s convenience, use of tailored web-based exercise resources, and companionable local support. Conclusions: This study highlights the inherent value of telephysiotherapy in aged care, emphasizing the need for investment in staff training, local support, and older adult–friendly resources in future telephysiotherapy iterations. TOP UP represents a convenient and flexible web-based care model that empowers many older adults to receive sustainable, high-quality care precisely when and where they need it. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN 1261000734864; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12621000734864 %M 38324369 %R 10.2196/53010 %U https://aging.jmir.org/2024/1/e53010 %U https://doi.org/10.2196/53010 %U http://www.ncbi.nlm.nih.gov/pubmed/38324369 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e47545 %T A Web-Based Peer-Patient Navigation Program (Compassionate Online Navigation to Enhance Care Transitions) for Youth Living With Childhood-Acquired Disabilities Transitioning From Pediatric to Adult Care: Qualitative Descriptive Study %A Kokorelias,Kristina Marie %A Lee,Tin-Suet Joan %A Bayley,Mark %A Seto,Emily %A Toulany,Alene %A Nelson,Michelle L A %A Dimitropoulos,Gina %A Penner,Melanie %A Simpson,Robert %A Munce,Sarah E P %+ KITE Research Institute, Toronto Rehabilitation Institute-University Health Network, Room 106, 345 Rumsey Road, Toronto, ON, M4G 1R7, Canada, 1 416 597 3422, sarah.munce@uhn.ca %K youth %K patient navigation %K web-based intervention %K peer support %K transition %K childhood disability %K caregiver %K transitional care intervention %K social support %K usability %K program %K children %K pediatric %K disability %K digital health %K eHealth %K web-based support %K web-based health %D 2024 %7 7.2.2024 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Studies have highlighted significant challenges associated with the transition from pediatric to adult health and social care services for youth living with childhood-acquired disabilities and their caregivers. Patient navigation has been proposed as an effective transitional care intervention. Better understanding of how patient navigation may support youth and their families during pediatric to adult care transitions is warranted. Objective: This study aims to describe the preferred adaptations of an existing web-based platform from the perspectives of youth with childhood-onset disabilities and their family caregivers to develop a web-based peer-patient navigation program, Compassionate Online Navigation to Enhance Care Transitions (CONNECT). Methods: A qualitative descriptive design was used. Participants included youth living with childhood-acquired disabilities (16/23, 70%) and their caregivers (7/23, 30%). Semistructured interviews and focus groups were conducted, digitally recorded, and transcribed. Thematic analysis was used to analyze the data and was facilitated through NVivo software (Lumivero). Results: Participants desired a program that incorporated (1) self-directed learning, (2) a library of reliable health and community resources, and (3) emotional and social supports. On the basis of participants’ feedback, CONNECT was deemed satisfactory, as it was believed that the program would help support appropriate transition care through the provision of trusted health-related information. Participants highlighted the need for options to optimize confidentiality in their health and social care and the choice to remain anonymous to other participants. Conclusions: Web-based patient navigation programs such as CONNECT may deliver peer support that can improve the quality and experience of care for youth, and their caregivers, transitioning from pediatric to adult care through personalized support, health care monitoring, and health and social care resources. Future studies are needed to test the feasibility, acceptability, usability, use, and effectiveness of CONNECT among youth with childhood-onset disabilities. %M 38324351 %R 10.2196/47545 %U https://pediatrics.jmir.org/2024/1/e47545 %U https://doi.org/10.2196/47545 %U http://www.ncbi.nlm.nih.gov/pubmed/38324351 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e54600 %T Benefits, Recruitment, Dropout, and Acceptability of the Strength Back Digital Health Intervention for Patients Undergoing Spinal Surgery: Nonrandomized, Qualitative, and Quantitative Pilot Feasibility Study %A van der Horst,Annemieke %A Meijer,Laura %A van Os - Medendorp,Harmieke %A Jukema,Jan S %A Bohlmeijer,Ernst %A Schreurs,Karlein MG %A Kelders,Saskia %+ Department of Psychology, Health and Technology, Centre for eHealth & Well-being Research - Behavioural, Management and Social Sciences, University of Twente, PO BOX 217, Enschede, 7500 AE, Netherlands, 31 (0)53 489 4470, a.vanderhorst-1@utwente.nl %K pilot feasibility study %K spinal surgery %K digital health intervention %K positive psychology %K acceptance and commitment therapy %K mobile phone %D 2024 %7 7.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Patients undergoing spinal surgery report high levels of insecurity, pain, stress, and anxiety before and after surgery. Unfortunately, there is no guarantee that surgery will resolve all issues; postsurgical recovery often entails moderate to severe postoperative pain, and some patients undergoing spinal surgery do not experience (long-term) pain relief after surgery. Therefore, focusing on sustainable coping skills and resilience is crucial for these patients. A digital health intervention based on acceptance and commitment therapy (ACT) and positive psychology (PP) was developed to enhance psychological flexibility and well-being and reduce postsurgical pain. Objective: The objective of this study was 3-fold: to explore the potential benefits for patients undergoing spinal surgery of the digital ACT and PP intervention Strength Back (research question [RQ] 1), explore the feasibility of a future randomized controlled trial in terms of recruitment and dropout (RQ 2), and assess the acceptability of Strength Back by patients undergoing spinal surgery (RQ 3). Methods: We used a nonrandomized experimental design with an intervention group (n=17) and a control group (n=20). To explore the potential benefits of the intervention, participants in both groups filled out questionnaires before and after surgery. These questionnaires included measurements of pain intensity (Numeric Pain Rating Scale), pain interference (Multidimensional Pain Inventory), anxiety and depression (Hospital Anxiety and Depression Scale), valued living (Engaged Living Scale), psychological flexibility (Psychological Inflexibility in Pain Scale), and mental well-being (Mental Health Continuum–Short Form). Semistructured interviews combined with log data and scores on the Twente Engagement With eHealth Technologies Scale were used to assess the acceptability of the intervention. Results: A significant improvement over time in emotional (V=99; P=.03) and overall (V=55; P=.004) well-being (Mental Health Continuum–Short Form) was observed only in the intervention group. In addition, the intervention group showed a significantly larger decline in pain intensity (Numeric Pain Rating Scale) than did the control group (U=75; P=.003). Of the available weekly modules on average 80% (12/15) was completed by patients undergoing spinal fusion and 67% (6/9) was completed by patients undergoing decompression surgery. A total of 68% (17/25) of the participants used the intervention until the final interview. Most participants (15/17, 88%) in the intervention group would recommend the intervention to future patients. Conclusions: This pilot feasibility study showed that combining ACT and PP in a digital health intervention is promising for patients undergoing spinal surgery as the content was accepted by most of the participants and (larger) improvements in pain intensity and well-being were observed in the intervention group. A digital intervention for patients undergoing (spinal) surgery can use teachable moments, when patients are open to learning more about the surgery and rehabilitation afterward. A larger randomized controlled trial is now warranted. %M 38324374 %R 10.2196/54600 %U https://formative.jmir.org/2024/1/e54600 %U https://doi.org/10.2196/54600 %U http://www.ncbi.nlm.nih.gov/pubmed/38324374 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e47372 %T Explainable Machine Learning Classification to Identify Vulnerable Groups Among Parenting Mothers: Web-Based Cross-Sectional Questionnaire Study %A Hanai,Akiko %A Ishikawa,Tetsuo %A Sugao,Shoko %A Fujii,Makoto %A Hirai,Kei %A Watanabe,Hiroko %A Matsuzaki,Masayo %A Nakamoto,Goji %A Takeda,Toshihiro %A Kitabatake,Yasuji %A Itoh,Yuichi %A Endo,Masayuki %A Kimura,Tadashi %A Kawakami,Eiryo %+ Medical Data Mathematical Reasoning Team, Advanced Data Science Project, RIKEN Information R&D and Strategy Headquarters, RIKEN, W507/509 West Research Building,, 1-7-22 Suehiro-cho, Tsurumi-ku, Yokohama, 230-0045, Japan, 81 455039455, tetsuo.ishikawa@riken.jp %K explainable machine-learning %K unsupervised clustering %K perceived support %K resilience %K adaptation %K mother’s health %K mobile phone %K machine learning %K web-based %K parenting %K postpartum %K antenatal %K survey %K mother %K women %K newborn %K psychosocial %K infant %K parents %K children %K depression %K digital health %K maternal %D 2024 %7 7.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: One life event that requires extensive resilience and adaptation is parenting. However, resilience and perceived support in child-rearing vary, making the real-world situation unclear, even with postpartum checkups. Objective: This study aimed to explore the psychosocial status of mothers during the child-rearing period from newborn to toddler, with a classifier based on data on the resilience and adaptation characteristics of mothers with newborns. Methods: A web-based cross-sectional survey was conducted. Mothers with newborns aged approximately 1 month (newborn cohort) were analyzed to construct an explainable machine learning classifier to stratify parenting-related resilience and adaptation characteristics and identify vulnerable populations. Explainable k-means clustering was used because of its high explanatory power and applicability. The classifier was applied to mothers with infants aged 2 months to 1 year (infant cohort) and mothers with toddlers aged >1 year to 2 years (toddler cohort). Psychosocial status, including depressed mood assessed by the Edinburgh Postnatal Depression Scale (EPDS), bonding assessed by the Postpartum Bonding Questionnaire (PBQ), and sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI) between the classified groups, was compared. Results: A total of 1559 participants completed the survey. They were split into 3 cohorts, comprising populations of various characteristics, including parenting difficulties and psychosocial measures. The classifier, which stratified participants into 5 groups, was generated from the self-reported scores of resilience and adaptation in the newborn cohort (n=310). The classifier identified that the group with the greatest difficulties in resilience and adaptation to a child’s temperament and perceived support had higher incidences of problems with depressed mood (relative prevalence [RP] 5.87, 95% CI 2.77-12.45), bonding (RP 5.38, 95% CI 2.53-11.45), and sleep quality (RP 1.70, 95% CI 1.20-2.40) compared to the group with no difficulties in perceived support. In the infant cohort (n=619) and toddler cohort (n=461), the stratified group with the greatest difficulties had higher incidences of problems with depressed mood (RP 9.05, 95% CI 4.36-18.80 and RP 4.63, 95% CI 2.38-9.02, respectively), bonding (RP 1.63, 95% CI 1.29-2.06 and RP 3.19, 95% CI 2.03-5.01, respectively), and sleep quality (RP 8.09, 95% CI 4.62-16.37 and RP 1.72, 95% CI 1.23-2.42, respectively) compared to the group with no difficulties. Conclusions: The classifier, based on a combination of resilience and adaptation to the child’s temperament and perceived support, was able identify psychosocial vulnerable groups in the newborn cohort, the start-up stage of childcare. Psychosocially vulnerable groups were also identified in qualitatively different infant and toddler cohorts, depending on their classifier. The vulnerable group identified in the infant cohort showed particularly high RP for depressed mood and poor sleep quality. %M 38324356 %R 10.2196/47372 %U https://formative.jmir.org/2024/1/e47372 %U https://doi.org/10.2196/47372 %U http://www.ncbi.nlm.nih.gov/pubmed/38324356 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55700 %T Physical Activity Intervention for Urban Black Women With Asthma: Protocol for a Randomized Controlled Efficacy Study %A Davis,Ellen %A Townsend,Elizabeth %A Cavalier,Aero %A Chen,Yi-Fan %A Edwards-Hart,Dameka %A Kitsiou,Spyros %A Kowalczyk,Wiktoria %A Mansur,Iliana %A Okpara,Ebere %A Powell,Karen %A Press,Valerie G %A Ramirez,Toni %A Salvo,Deborah %A Sharp,Lisa K %A Wright,Brittani %A Nyenhuis,Sharmilee Maria %+ Section of Allergy and Immunology, Department of Pediatrics, University of Chicago, 5837 S Maryland Ave, Chicago, IL, 60637, United States, 1 7738347121, snyenhuis@bsd.uchicago.edu %K asthma %K physical activity %K lifestyle %K Black women %D 2024 %7 7.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Black women experience a higher prevalence of poor asthma outcomes and physical inactivity than their White counterparts. Black women comprise a particularly vulnerable group of patients with asthma, with some of the highest rates of asthma in adults, high health care use (emergency department visits and hospitalizations), and the highest crude asthma mortality rate of all race or ethnicity groups. Despite recommendations to engage in regular physical activity, fewer than 15% of Black women meet the 2008 National Physical Activity Guidelines, the lowest of all racial subgroups of adults. Given the connection between physical inactivity and poor asthma outcomes, addressing physical activity among Black women with asthma is imperative. Objective: This 2-arm randomized controlled trial aims to (1) determine the efficacy of a lifestyle walking intervention on asthma control compared to an education (control) group over 24 weeks, (2) examine the maintenance effects of the lifestyle walking intervention on asthma control at 48 weeks, (3) explore the behavioral mediators (eg, self-efficacy, social support, self-regulation, and daily physical activity levels) and contextual moderators (eg, baseline asthma severity, neighborhood environment, comorbid conditions, and social determinants of health) that contribute to treatment responsiveness, and (4) assess the reach and implementation potential of the intervention. Methods: The proposed study (ACTION [A Lifestyle Physical Activity Intervention for Minority Women with Asthma]) delivers a 24-week lifestyle walking intervention designed for and by urban Black women with asthma. Participants (n=224) will be recruited through 2 urban health care systems that care for a diverse Black population. Patients will be randomized to one of two groups: (1) ACTION intervention (group sessions, physical activity self-monitoring—Fitbit, and text-based support for step goal setting) or (2) education control (an individual asthma education session and SMS text messages related to asthma education). Outcome assessments will take place at baseline, 12, 24, and 48 weeks. The primary outcome is a change in asthma control from baseline to week 24 as assessed by the asthma control questionnaire-6 (ACQ-6). Secondary outcomes include asthma-related quality of life, health care use, and asthma exacerbations and behavioral outcomes such as self-efficacy, self-regulation, social support, and physical activity. Results: This study was funded by the National Institute of Minority Health Disparities in August 2022. We pilot-tested our recruitment and intervention procedures and began recruitment in April 2023, with the enrollment of our first participant in May 2023. The anticipated completion of the study is April 2027. Conclusions: This study will deliver a new approach to physical activity interventions in Black women with asthma and help to provide guidance for addressing physical activity within this subgroup. This study will also provide a potential framework for future studies in minoritized populations with other disease conditions associated with low levels of physical activity. Trial Registration: ClinicalTrials.gov NCT05726487; https://clinicaltrials.gov/study/NCT05726487 International Registered Report Identifier (IRRID): DERR1-10.2196/55700 %M 38324365 %R 10.2196/55700 %U https://www.researchprotocols.org/2024/1/e55700 %U https://doi.org/10.2196/55700 %U http://www.ncbi.nlm.nih.gov/pubmed/38324365 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e48668 %T Attitudes, Barriers, and Motivators Toward Daily Walking and a Mobile App to Increase Walking Among Women: Web-Based Anonymous Survey %A Jones,Catherine %A Chandarana,Shikha %A Vyas,Amita %A Napolitano,Melissa %+ Milken Institute School of Public Health, The George Washington University, 950 New Hampsire Avenue, Washington, DC, 20052, United States, 1 301 283 8703, catherinegjones@gwu.edu %K mHealth %K mobile health %K mobile app %K walking %K physical activity %K step counts %K women’s health %K age %K wearable activity tracker %K chronic disease %K mental health %K mobile phone %K COVID-19 %D 2024 %7 6.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: There are disparities in the prevalence of physical activity (PA) with women engaging in less PA than men, a gap which widens during midlife. Walking is a generally accepted form of PA among women and should be encouraged. Motivations, barriers, and attitudes to engaging in walking change with age, but the influencing factors are not well understood nor are the features of mobile apps that facilitate daily walking. Objective: This study explores the relationship between age and women’s self-reported motivations, barriers, attitudes, and beliefs toward daily walking. It further assesses attitudes toward features of a mobile app designed to sync with a wearable step tracker to increase and maintain levels of daily walking among women. Methods: A web-based anonymous survey was completed by 400 women, aged 21-75 years. The 31-item survey captured women’s perceived barriers and motivators toward daily walking and attitudes toward mobile apps to support and maintain daily walking. For analysis, responses to the survey were grouped into 2 categories of women: ages 21-49 years and ages 50-75 years. Bivariate analyses were conducted through SPSS (IBM Corp) for each of the survey questions using chi-square for dichotomous variables and 1-tailed t tests for scales and continuous variables to identify significant differences between the groups. One-tailed t tests were run for scaled variables to identify significant differences between the 10-year age increments. Results: Significant barriers to daily walking were observed in the 21-49–year group for personal and work responsibilities, motivational and psychosocial factors, and physical and environmental factors. Motivators to walk daily in the 21- 49–year group were significantly higher to reduce stress and anxiety, and motivators to walk daily in the 50-75–year group were significantly higher to help manage or lose weight and to reduce the risk of chronic illness. Women’s walking preferences, beliefs around their walking behaviors, and their perceived importance of the features of a future mobile app for walking designed specifically for women showed significant variation according to age. When asked about the importance of features for a mobile app, women aged 21-49 years indicated a significantly higher number of positive responses for the following features: digital community support, rewards or point system, and seeing a daily or weekly or monthly progress chart. Conclusions: Our findings indicate that barriers, motivators, and beliefs around daily walking and the importance of preferred features of a mobile app vary according to women’s ages. Messaging and app features should be tailored to different age groups of women. These study results can be viewed as a foundation for future research and development of mobile health interventions to effectively increase daily walking among women of all ages. %M 38319695 %R 10.2196/48668 %U https://formative.jmir.org/2024/1/e48668 %U https://doi.org/10.2196/48668 %U http://www.ncbi.nlm.nih.gov/pubmed/38319695 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e52571 %T Developing and Evaluating a Data-Driven and Systems Approach to Health Promotion Among Vocational Students: Protocol for the Data Health Study %A Heinze,Clara %A Hartmeyer,Rikke Dalgaard %A Sidenius,Anne %A Ringgaard,Lene Winther %A Bjerregaard,Anne-Louise %A Krølner,Rikke Fredenslund %A Allender,Steven %A Bauman,Adrian %A Klinker,Charlotte Demant %+ Department of Prevention, Health Promotion and Community Care, Copenhagen University Hospital - Steno Diabetes Center Copenhagen, Borgmester Ib Juuls Vej 83, Herlev, 2730, Denmark, 45 28838889, clara.heinze@regionh.dk %K health promotion %K health behavior %K well-being %K organizational readiness %K cocreation %K causal loop diagram %K systems thinking %K systems-based evaluation %K vocational schools %K youth %D 2024 %7 6.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Vocational school students exhibit significant risk behaviors in terms of poor diet, frequent use of nicotine products, inadequate fruit and vegetable intake, low levels of physical activity, and poor mental health. This makes vocational students vulnerable to the development of noncommunicable diseases. Therefore, effective health promotion programs targeting vocational students are required. Objective: The Danish study “Data-driven and Systems Approach to Health Promotion Among Vocational Students” (Data Health) aims to develop, implement, and evaluate a systems approach to support vocational schools, municipalities, and local communities in implementing locally relevant health promotion actions among and for vocational students. This paper describes the Data Health program and how implementation and preliminary effectiveness will be evaluated. Methods: The Data Health program offers an iterative 5-step process to develop changes in the systems that shape health behavior and well-being among vocational students. The program will be implemented and evaluated in 8 Danish vocational schools in 4 municipalities. The implementation of the process and actions will be explored using a systems-based evaluation design that assesses contextual differences and the mechanisms through which the program leads to changes in the systems. Preliminary effectiveness at the individual level (students’ self-reported health behavior and well-being) and organizational level (school organizational readiness reported by school staff) will be assessed using a quasi-experimental design, and cross-sectional data will be collected at all 8 schools simultaneously 4 times during the 2-year study period. Results: This study was launched in 2021, and data collection is expected to be completed in June 2024. The first results are expected to be submitted for publication in January 2024. Conclusions: We expect that the Data Health study will make significant contributions to complex intervention research by contributing to the paucity of research studies that have used systems approaches in school settings. The study will also provide evidence of successful elements for systems change and effectiveness to determine whether a national scale-up can be recommended. Trial Registration: ClinicalTrials.gov NCT05308459; https://clinicaltrials.gov/study/NCT05308459 International Registered Report Identifier (IRRID): DERR1-10.2196/52571 %M 38319698 %R 10.2196/52571 %U https://www.researchprotocols.org/2024/1/e52571 %U https://doi.org/10.2196/52571 %U http://www.ncbi.nlm.nih.gov/pubmed/38319698 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e46637 %T Effectiveness of Online and Remote Interventions for Mental Health in Children, Adolescents, and Young Adults After the Onset of the COVID-19 Pandemic: Systematic Review and Meta-Analysis %A Fischer-Grote,Linda %A Fössing,Vera %A Aigner,Martin %A Fehrmann,Elisabeth %A Boeckle,Markus %+ Department of Psychology and Psychodynamics, Karl Landsteiner University of Health Sciences, Dr.-Karl-Dorrek-Straße 30, Krems, 3500, Austria, 43 6503032923, elisabeth.fehrmann@kl.ac.at %K COVID-19 pandemic %K online/digital mental health intervention %K e-mental health %K anxiety %K social functioning %K depression %K well-being %K psychological distress %K eating disorder %K COVID-19 symptoms %D 2024 %7 5.2.2024 %9 Review %J JMIR Ment Health %G English %X Background: The prevalence of mental illness increased in children, adolescents, and young adults during the COVID-19 pandemic, while at the same time, access to treatment facilities has been restricted, resulting in a need for the quick implementation of remote or online interventions. Objective: This study aimed to give an overview of randomized controlled studies examining remote or online interventions for mental health in children, adolescents, and young adults and to explore the overall effectiveness of these interventions regarding different symptoms. Methods: A systematic literature search was conducted according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines using PubMed, PsycInfo, Psyndex, Embase, and Google Scholar. A meta-analysis was conducted using a random effects model to calculate overall effect sizes for interventions using standardized mean differences (SMDs) for postintervention scores. Results: We identified 17 articles with 8732 participants in the final sample, and 13 were included in the quantitative analysis. The studies examined different digital interventions for several outcomes, showing better outcomes than the control in some studies. Meta-analyses revealed significant medium overall effects for anxiety (SMD=0.44, 95% CI 0.20 to 0.67) and social functioning (SMD=0.42, 95% CI –0.68 to –0.17) and a large significant effect for depression (SMD=1.31, 95% CI 0.34 to 2.95). In contrast, no significant overall treatment effects for well-being, psychological distress, disordered eating, and COVID-19–related symptoms were found. Conclusions: The qualitative and quantitative analyses of the included studies show promising results regarding the effectiveness of online interventions, especially for symptoms of anxiety and depression and for training of social functioning. However, the effectiveness needs to be further investigated for other groups of symptoms in the future. All in all, more research with high-quality studies is required. %M 38315524 %R 10.2196/46637 %U https://mental.jmir.org/2024/1/e46637 %U https://doi.org/10.2196/46637 %U http://www.ncbi.nlm.nih.gov/pubmed/38315524 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 10 %N %P e46116 %T Digital Health Psychosocial Intervention in Adult Patients With Cancer and Their Families: Systematic Review and Meta-Analysis %A Zhang,Yingzi %A Flannery,Marie %A Zhang,Zhihong %A Underhill-Blazey,Meghan %A Bobry,Melanie %A Leblanc,Natalie %A Rodriguez,Darcey %A Zhang,Chen %+ Magnet Program and Nursing Research Department, UT Southwestern Medical Center, 8200 Brookriver Dr, Dallas, TX, 75247, United States, 1 469 291 4808, yingzi.zhang@utsouthwestern.edu %K cancer %K anxiety %K decision-making %K depression %K digital health %K distress %K family %K mental health %K mortality %K psychosocial intervention %K quality of life %D 2024 %7 5.2.2024 %9 Review %J JMIR Cancer %G English %X Background: Patients with cancer and their families often experience significant distress and deterioration in their quality of life. Psychosocial interventions were used to address patients’ and families’ psychosocial needs. Digital technology is increasingly being used to deliver psychosocial interventions to patients with cancer and their families. Objective: A systematic review and meta-analysis were conducted to review the characteristics and effectiveness of digital health interventions on psychosocial outcomes in adult patients with cancer and their family members. Methods: Databases (PubMed, Cochrane Library, Web of Science, Embase, CINAHL, PsycINFO, ProQuest Dissertations and Theses Global, and ClinicalTrials.gov) were searched for randomized controlled trials (RCTs) or quasi-experimental studies that tested the effects of a digital intervention on psychosocial outcomes. The Joanna Briggs Institute’s critical appraisal checklists for RCTs and quasi-experimental studies were used to assess quality. Standardized mean differences (ie, Hedges g) were calculated to compare intervention effectiveness. Subgroup analysis was planned to examine the effect of delivery mode, duration of the intervention, type of control, and dosage on outcomes using a random-effects modeling approach. Results: A total of 65 studies involving 10,361 patients (mean 159, SD 166; range 9-803 patients per study) and 1045 caregivers or partners (mean 16, SD 54; range 9-244 caregivers or partners per study) were included in the systematic review. Of these, 32 studies were included in a meta-analysis of the effects of digital health interventions on quality of life, anxiety, depression, distress, and self-efficacy. Overall, the RCT studies’ general quality was mixed (applicable scores: mean 0.61, SD 0.12; range 0.38-0.91). Quasi-experimental studies were generally of moderate to high quality (applicable scores: mean 0.75, SD 0.08; range 0.63-0.89). Psychoeducation and cognitive-behavioral strategies were commonly used. More than half (n=38, 59%) did not identify a conceptual or theoretical framework. Most interventions were delivered through the internet (n=40, 62%). The median number of intervention sessions was 6 (range 1-56). The frequency of the intervention was highly variable, with self-paced (n=26, 40%) being the most common. The median duration was 8 weeks. The meta-analysis results showed that digital psychosocial interventions were effective in improving patients’ quality of life with a small effect size (Hedges g=0.05, 95% CI –0.01 to 0.10; I2=42.7%; P=.01). The interventions effectively reduced anxiety and depression symptoms in patients, as shown by moderate effect sizes on Hospital Anxiety and Depression Scale total scores (Hedges g=–0.72, 95% CI –1.89 to 0.46; I2=97.6%; P<.001). Conclusions: This study demonstrated the effectiveness of digital health interventions on quality of life, anxiety, and depression in patients. Future research with a clear description of the methodology to enhance the ability to perform meta-analysis is needed. Moreover, this study provides preliminary evidence to support the integration of existing digital health psychosocial interventions in clinical practice. Trial Registration: PROSPERO CRD42020189698; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=189698 %M 38315546 %R 10.2196/46116 %U https://cancer.jmir.org/2024/1/e46116 %U https://doi.org/10.2196/46116 %U http://www.ncbi.nlm.nih.gov/pubmed/38315546 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e50977 %T Patient Satisfaction With a Coach-Guided, Technology-Based Mental Health Treatment: Qualitative Interview Study and Theme Analysis %A Smith,Ashley Helm %A Touchett,Hilary %A Chen,Patricia %A Fletcher,Terri %A Arney,Jennifer %A Hogan,Julianna %A Wassef,Miryam %A Cloitre,Marylene %A Lindsay,Jan A %+ Houston Veteran Affairs Health Services Research and Development Center for Innovations in Quality, Effectiveness and Safety, Michael E DeBakey Veteran Affairs Medical Center, 2002 Holcombe Blvd. (152), Houston, TX, 77030, United States, 1 713 794 8601, ashley.smith30@va.gov %K coaching %K digital treatment %K interview %K mental health %K patient satisfaction %K PTSD %K qualitative assessment %K qualitative methods %K sentiment analysis %K technology-based %K telehealth %K trauma %K veterans %K video telehealth %K web-based treatment %D 2024 %7 2.2.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Technology-based mental health interventions address barriers rural veterans face in accessing care, including provider scarcity and distance from the hospital or clinic. webSTAIR is a 10-module, web-based treatment based on Skills Training in Affective and Interpersonal Regulation, designed to treat posttraumatic stress disorder and depression in individuals exposed to trauma. Previous work has demonstrated that webSTAIR is acceptable to participants and effective at reducing symptoms of posttraumatic stress disorder and depression when delivered synchronously or asynchronously (over 5 or 10 sessions). Objective: This study explored factors that lead to greater patient satisfaction with webSTAIR, a web-based, coach-guided intervention. Methods: We analyzed qualitative interview data to identify themes related to patient satisfaction with webSTAIR delivered with synchronous video-based coaching. Results: Four themes emerged from the data: (1) coaching provides accountability and support, (2) self-pacing offers value that meets individual needs, (3) participants like the comfort and convenience of the web-based format, and (4) technical issues were common but not insurmountable. Conclusions: We conclude that participants valued the accountability, flexibility, and convenience of tech-based interventions with video-delivered coaching. %M 38306167 %R 10.2196/50977 %U https://mental.jmir.org/2024/1/e50977 %U https://doi.org/10.2196/50977 %U http://www.ncbi.nlm.nih.gov/pubmed/38306167 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e51066 %T Acceptability and Utility of a Digital Group Intervention to Prevent Perinatal Depression in Youths via Interactive Maternal Group for Information and Emotional Support (IMAGINE): Pilot Cohort Study %A Ronen,Keshet %A Gewali,Anupa %A Dachelet,Kristin %A White,Erica %A Jean-Baptiste,Marimirca %A Evans,Yolanda N %A Unger,Jennifer A %A Tandon,S Darius %A Bhat,Amritha %+ Department of Global Health, University of Washington, 3980 15th Avenue North East, Seattle, WA, 98195, United States, 1 2066854363, keshet@uw.edu %K perinatal depression %K youth %K mHealth %K digital health %K acceptability %K utility %K depression %K pilot study %K pregnancy %K postpartum %K prevention %K cognitive behavioral therapy %K psychoeducation %K mixed methods %K manage %K mood %K mobile phone %D 2024 %7 2.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Perinatal depression (depression during pregnancy or the first year postpartum) affects 10%-25% of perinatal individuals, with a higher risk among youths aged <25 years. The Mothers and Babies Course (MB) is an evidence-based intervention for the prevention of perinatal depression, grounded in cognitive behavioral therapy, attachment theory, and psychoeducation. Objective: We developed a digital adaptation of MB (Interactive Maternal Group for Information and Emotional Support [IMAGINE]) and evaluated it in a pre-post mixed methods pilot among young perinatal people in the United States. Methods: IMAGINE was a structured digital group of up to 7 participants, with scheduled MB content and open discussion for 12 weeks, facilitated by a social worker. Scheduled content included asynchronous SMS text messages, graphics, prerecorded videos, mood polls, and optional weekly synchronous video calls. Eligible participants were pregnant or ≤80 days postpartum, aged 16 to 24 years, had access to a smartphone, spoke English, and had a Patient Health Questionnaire score <10. Participants were recruited throughout the United States from August 2020 to January 2021 through paid social media ads, in-person outreach at clinics, and respondent-driven sampling. Participants completed quantitative questionnaires at enrollment and 3 months, and qualitative interviews at 3 months. We determined uptake, acceptability (by Acceptability of Intervention Measure score), and utility (by use of cognitive behavioral therapy skills). We compared depression symptoms (by Patient Health Questionnaire score), social support (by abbreviated Social Support Behavior score), and perceived stress (by Perceived Stress Score) between enrollment and follow-up by paired 2-tailed t test. Results: Among 68 individuals who contacted this study, 22 were screened, 13 were eligible, and 10 enrolled, for an uptake of 76.9%. Furthermore, 4 (40%) participants were pregnant at enrollment. Participants had a median age of 17.9 (IQR 17.4-21.7) years, 6 (67%) identified as Black, 5 (56%) Latinx, and 6 (67%) using Medicaid health insurance. Further, 9 (90%) participants completed follow-up. Among these, the mean acceptability score was 4.3 out of 5 (SD 0.6) and all participants said they would recommend IMAGINE to a friend. Participants reported using a median of 7 of 11 skills (IQR 5-7 skills) at least half the days. We found no significant changes in depression symptoms, perceived stress, or social support. Qualitatively, participants reported one-to-one support from the facilitator, connection with other parents, and regular mood reflection were especially helpful aspects of the intervention. Additionally, participants reported that the intervention normalized their mental health challenges, improved their ability to manage their mood, and increased their openness to mental health care. Conclusions: This pilot study provides promising evidence of the acceptability and utility of IMAGINE among perinatal youths. Our study’s small sample size did not detect changes in clinical outcomes; our findings suggest IMAGINE warrants larger-scale evaluation. %M 38306159 %R 10.2196/51066 %U https://formative.jmir.org/2024/1/e51066 %U https://doi.org/10.2196/51066 %U http://www.ncbi.nlm.nih.gov/pubmed/38306159 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e51021 %T Support for Chronic Pain Management for Breast Cancer Survivors Through Novel Digital Health Ecosystems: Pilot Usability Study of the PainRELife Mobile App %A Masiero,Marianna %A Filipponi,Chiara %A Fragale,Elisa %A Pizzoli,Silvia Francesca Maria %A Munzone,Elisabetta %A Milani,Alessandra %A Guido,Luca %A Guardamagna,Vittorio %A Marceglia,Sara %A Prandin,Roberto %A Prenassi,Marco %A Caruso,Annamaria %A Manzelli,Vania %A Savino,Chiara %A Conti,Costanza %A Rizzi,Federica %A Casalino,Alice %A Candiani,Giulia %A Memini,Francesca %A Chiveri,Luca %A Vitali,Andrea Luigi %A Corbo,Massimo %A Grasso,Roberto %A Didier,Florence %A Ferrucci,Roberta %A Pravettoni,Gabriella %+ Department of Oncology and Hemato-Oncology, University of Milan, Via Festa del Perdono 7, Milan, 20122, Italy, 39 0294372009, marianna.masiero@unimi.it %K chronic pain %K eHealth %K cancer %K decision-making %K survivorship %K self-efficacy %K pain %K oncology %K health ecosystem %K health ecosystems %K breast %K survivor %K survivors %K mHealth %K mobile health %K app %K apps %K applications %K MARS %D 2024 %7 2.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Chronic pain is one of the most common and critical long-term effects of breast cancer. Digital health technologies enhance the management of chronic pain by monitoring physical and psychological health status and supporting pain self-management and patient treatment decisions throughout the clinical pathway. Objective: This pilot study aims to evaluate patients’ experiences, including usability, with a novel digital integrated health ecosystem for chronic pain named PainRELife. The sample included patients with breast cancer during survivorship. The PainRELife ecosystem comprises a cloud technology platform interconnected with electronic health records and patients' devices to gather integrated health care data. Methods: We enrolled 25 patients with breast cancer (mean age 47.12 years) experiencing pain. They were instructed to use the PainRELife mobile app for 3 months consecutively. The Mobile Application Rating Scale (MARS) was used to evaluate usability. Furthermore, pain self-efficacy and participation in treatment decisions were evaluated. The study received ethical approval (R1597/21-IEO 1701) from the Ethical Committee of the European Institute of Oncology. Results: The MARS subscale scores were medium to high (range: 3.31-4.18), and the total app quality score was 3.90. Patients with breast cancer reported reduced pain intensity at 3 months, from a mean of 5 at T0 to a mean of 3.72 at T2 (P=.04). The total number of times the app was accessed was positively correlated with pain intensity at 3 months (P=.03). The engagement (P=.03), information (P=.04), and subjective quality (P=.007) subscales were positively correlated with shared decision-making. Furthermore, participants with a lower pain self-efficacy at T2 (mean 40.83) used the mobile app more than participants with a higher pain self-efficacy (mean 48.46; P=.057). Conclusions: The data collected in this study highlight that digital health technologies, when developed using a patient-driven approach, might be valuable tools for increasing participation in clinical care by patients with breast cancer, permitting them to achieve a series of key clinical outcomes and improving quality of life. Digital integrated health ecosystems might be important tools for improving ongoing monitoring of physical status, psychological burden, and socioeconomic issues during the cancer survivorship trajectory. International Registered Report Identifier (IRRID): RR2-10.2196/41216 %M 38306176 %R 10.2196/51021 %U https://formative.jmir.org/2024/1/e51021 %U https://doi.org/10.2196/51021 %U http://www.ncbi.nlm.nih.gov/pubmed/38306176 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e50780 %T Race, Ethnicity, and Other Cultural Background Factors in Trials of Internet-Based Cognitive Behavioral Therapy for Depression: Systematic Review %A De Jesús-Romero,Robinson %A Holder-Dixon,Amani R %A Buss,John F %A Lorenzo-Luaces,Lorenzo %+ Department of Psychological and Brain Sciences, Indiana University - Bloomington, 1101 East 10th Street, Bloomington, IN, 47405, United States, 1 7872409456, robdejes@iu.edu %K diversity %K cognitive behavioral therapy %K internet-based %K depression %K race %K racial %K ethnicity %K culture %K depressive %K diverse %K inclusive %K inclusivity %K DEI %K diversity, equity, and inclusion %K internet-based cognitive behavioral therapy %K mental health %K ethnic %K cultures %K culturally %K review methods %K review methodology %K systematic %K clinical trial %K clinical trials %K randomized controlled trial %K randomized controlled trials %K controlled trial %K controlled trials %K reporting %K immigrant %K migrant %K migrants %K immigrants %K psychotherapy %K underrepresented %K underrepresentation %K representation %K mobile phone %D 2024 %7 1.2.2024 %9 Review %J J Med Internet Res %G English %X Background: There is a growing interest in developing scalable interventions, including internet-based cognitive behavioral therapy (iCBT), to meet the increasing demand for mental health services. Given the growth in diversity worldwide, it is essential that the clinical trials of iCBT for depression include diverse samples or, at least, report information on the race, ethnicity, or other background indicators of their samples. Unfortunately, the field lacks data on how well diversity is currently reported and represented in the iCBT literature. Objective: Thus, the main objective of this systematic review was to examine the overall reporting of racial and ethnic identities in published clinical trials of iCBT for depression. We also aimed to review the representation of specific racial and ethnic minoritized groups and the inclusion of alternative background indicators such as migration status or country of residence. Methods: Studies were included if they were randomized controlled trials in which iCBT was compared to a waiting list, care-as-usual, active control, or another iCBT. The included papers also had to have a focus on acute treatment (eg, 4 weeks to 6 months) of depression, be delivered via the internet on a website or a smartphone app and use guided or unguided self-help. Studies were initially identified from the METAPSY database (n=59) and then extended to include papers up to 2022, with papers retrieved from Embase, PubMed, PsycINFO, and Cochrane (n=3). Risk of bias assessment suggested that reported studies had at least some risk of bias due to use of self-report outcome measures. Results: A total of 62 iCBT randomized controlled trials representing 17,210 participants are summarized in this study. Out of those 62 papers, only 17 (27%) of the trials reported race, and only 12 (19%) reported ethnicity. Reporting outside of the United States was very poor, with the United States accounting for 15 (88%) out of 17 of studies that reported race and 9 (75%) out of 12 for ethnicity. Out of 3,623 participants whose race was reported in the systematic review, the racial category reported the most was White (n=2716, 74.9%), followed by Asian (n=209, 5.8%) and Black (n=274, 7.6%). Furthermore, only 25 (54%) out of the 46 papers conducted outside of the United States reported other background demographics. Conclusions: It is important to note that the underreporting observed in this study does not necessarily indicate an underrepresentation in the actual study population. However, these findings highlight the poor reporting of race and ethnicity in iCBT trials for depression found in the literature. This lack of diversity reporting may have significant implications for the scalability of these interventions. %M 38300699 %R 10.2196/50780 %U https://www.jmir.org/2024/1/e50780 %U https://doi.org/10.2196/50780 %U http://www.ncbi.nlm.nih.gov/pubmed/38300699 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e42976 %T The Evaluation of the GET.ON Nationwide Web-Only Treatment Service for Depression- and Stress-Related Symptoms: Naturalistic Trial %A Etzelmueller,Anne %A Heber,Elena %A Horvath,Hanne %A Radkovsky,Anna %A Lehr,Dirk %A Ebert,David Daniel %+ Department of Sports and Health Sciences, Professorship Psychology and Digital Mental Health Care, Technical University of Munich, Georg-Brauchle-Ring 60, Munich, 80992, Germany, 49 621345167, anneetzelmueller@gmail.com %K depression %K stress %K digital %K internet %K effectiveness %K routine care %D 2024 %7 1.2.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: GET.ON (HelloBetter) treatment interventions have been shown to be efficacious in multiple randomized controlled trials. Objective: This study evaluated the effectiveness of 2 GET.ON interventions, GET.ON Mood Enhancer and GET.ON Stress, in a national digital mental health service implemented across Germany. Methods: Following an initial web-based questionnaire, participants were allocated to either intervention based on their baseline symptom severity and personal choice and received a semistandardized guided, feedback-on-demand guided, or self-guided version of the treatment. Uncontrolled routine care data from 851 participants were analyzed using a pretest-posttest design. Half of the participants (461/851, 54.2%) were allocated to the stress intervention (189/461, 41% semistandardized; 240/461, 52% feedback on demand; and 32/461, 6.9% self-guided), and almost all participants in the mood intervention (349/352, 99.2%) received semistandardized guidance. Results: Results on depression-related symptom severity indicated a reduction in reported symptoms, with a large effect size of d=−0.92 (95% CI −1.21 to −0.63). Results on perceived stress and insomnia indicated a reduction in symptom severity, with large effect sizes of d=1.02 (95% CI −1.46 to −0.58) and d=−0.75 (95% CI −1.10 to −0.40), respectively. A small percentage of participants experienced deterioration in depression-related symptoms (11/289, 3.8%), perceived stress (6/296, 2%), and insomnia (5/252, 2%). After completing treatment, 51.9% (150/289) of participants showed a clinically reliable change in depression-related symptoms, whereas 20.4% (59/289) achieved a close to symptom-free status. Similar improvements were observed in perceived stress and insomnia severity. Guidance moderated the effectiveness of and adherence to the interventions in reducing depressive symptom severity. Effect sizes on depression-related symptom severity were d=−1.20 (95% CI −1.45 to −0.93) for the semistandardized group, d=−0.36 (95% CI −0.68 to −0.04) for the feedback-on-demand group, and d=−0.83 (95% CI −1.03 to −0.63) for the self-guided group. Furthermore, 47.6% (405/851) of the participants completed all modules of the intervention. Participant satisfaction was high across all patient groups and both interventions; 89.3% (242/271) of participants would recommend it to a friend in need of similar help. Limitations include the assignment to treatments and guidance formats based on symptom severity. Furthermore, part of the differences in symptom change between groups must be assumed to be due to this baseline difference in the measures. Conclusions: Future digital health implementation and routine care research should focus on monitoring symptom deterioration and other negative effects, as well as possible predictors of deterioration and the investigation of individual patient trajectories. In conclusion, this study supports the effectiveness of tailored digital mental health services in routine care for depression- and stress-related symptoms in Germany. The results highlight the importance of guidance in delivering internet-based cognitive behavioral therapy interventions and provide further evidence for its potential delivered as web-only solutions for increasing access to and use of psychological treatments. %M 38300701 %R 10.2196/42976 %U https://www.jmir.org/2024/1/e42976 %U https://doi.org/10.2196/42976 %U http://www.ncbi.nlm.nih.gov/pubmed/38300701 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e53262 %T mHealth Apps for the Self-Management of Low Back Pain: Systematic Search in App Stores and Content Analysis %A Zhou,Tianyu %A Salman,David %A McGregor,Alison %+ Department of Surgery and Cancer, Imperial College London, MSk lab, Sir Michael Uren Hub, 86 Wood Lan, London, W12 0BZ, United Kingdom, 44 7421760832, t.zhou20@imperial.ac.uk %K smartphone %K mHealth %K mobile health %K low back pain %K self-management %K treatment interventions %K mobile phone %D 2024 %7 1.2.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: With the rapid development of mobile health (mHealth) technology, many health apps have been introduced to the commercial market for people with back pain conditions. However, little is known about their content, quality, approaches to care for low back pain (LBP), and associated risks of use. Objective: The aims of this research were to (1) identify apps for the self-management of LBP currently on the market and (2) assess their quality, intervention content, theoretical approaches, and risk-related approaches. Methods: The UK iTunes and Google Play stores were initially searched for apps related to the self-management of LBP in May 2022. A repeat search in June 2023 was conducted to ensure that any relevant new apps developed in the last year were incorporated into the review. A total of 3 keywords recommended by the Cochrane Back and Neck Group were used to search apps “low back pain,” “back pain,” and “lumbago.” The quality of the apps was assessed by using the 5-point Mobile App Rating Scale (MARS). Results: A total of 69 apps (25 iOS and 44 Android) met the inclusion criteria. These LBP self-management apps mainly provide recommendations on muscle stretching (n=51, 73.9%), muscle strengthening (n=42, 60.9%), core stability exercises (n=32, 46.4%), yoga (n=19, 27.5%), and information about LBP mechanisms (n=17, 24.6%). Most interventions (n=14, 78%) are consistent with the recommendations in the National Institute for Health and Care Excellence (NICE) guidelines. The mean (SD) MARS overall score of included apps was 2.4 (0.44) out of a possible 5 points. The functionality dimension was associated with the highest score (3.0), whereas the engagement and information dimension resulted in the lowest score (2.1). Regarding theoretical and risk-related approaches, 18 (26.1%) of the 69 apps reported the rate of intervention progression, 11 (15.9%) reported safety checks, only 1 (1.4%) reported personalization of care, and none reported the theoretical care model or the age group targeted. Conclusions: mHealth apps are potentially promising alternatives to help people manage their LBP; however, most of the LBP self-management apps were of poor quality and did not report the theoretical approaches to care and their associated risks. Although nearly all apps reviewed included a component of care listed in the NICE guidelines, the model of care delivery or embracement of care principles such as the application of a biopsychosocial model was unclear. %M 38300700 %R 10.2196/53262 %U https://mhealth.jmir.org/2024/1/e53262 %U https://doi.org/10.2196/53262 %U http://www.ncbi.nlm.nih.gov/pubmed/38300700 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e47102 %T Effectiveness of a Nurse-Led Mobile-Based Health Coaching Program for Patients With Prostate Cancer at High Risk of Metabolic Syndrome: Randomized Waitlist Controlled Trial %A Lee,Kyoungjin %A Park,Jeongok %A Oh,Eui Geum %A Lee,JuHee %A Park,Chang %A Choi,Young Deuk %+ Mo-Im Kim Nursing Research Institute, College of Nursing, Yonsei University, Seodaemun-gu, Seoul, Korea, Seoul, 03722, Republic of Korea, 82 2 2228 3390, JOPARK02@yuhs.ac %K nurses %K prostate neoplasms %K healthy lifestyle %K metabolic syndrome %K exercise %K diet %K mobile phone %D 2024 %7 1.2.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Androgen deprivation therapy (ADT), a standard treatment for prostate cancer (PC), causes many physical side effects. In particular, it causes metabolic changes such as fasting glucose abnormalities or accumulation of body fat, and its continuation can lead to metabolic syndrome (MetS), which is closely related to diabetes and cardiovascular disease. Therefore, it is important to maintain and practice a healthy lifestyle in patients with PC. Objective: This study aims to evaluate the effectiveness of a nurse-led mobile-based program that aims to promote a healthy lifestyle in patients with PC undergoing ADT with MetS risk factors. Methods: This was a single-blind, randomized, waitlist control interventional study. A total of 48 patients were randomly assigned to the experimental and waitlist control groups at the urology cancer clinic of a tertiary general hospital in South Korea. The inclusion criteria were patients who had undergone ADT for >6 months, had at least 1 of the 5 MetS components in the abnormal range, and could access a mobile-based education program. The experimental group attended a 4-week mobile-based program on exercise and diet that included counseling and encouragement to maintain a healthy lifestyle, whereas the control group was placed on a waitlist and received usual care during the follow-up period, followed by the intervention. The primary outcome was a change in the lifestyle score. The secondary outcomes were changes in 5 MetS components, body composition, and health-related quality of life. The outcomes were measured at 6 weeks and 12 weeks after the initiation of the intervention. Each participant was assigned to each group in a sequential order of enrollment in a 4×4 permuted block design randomization table generated in the SAS (SAS Institute) statistical program. A linear mixed model was used for statistical analysis. Results: A total of 24 participants were randomly assigned to each group; however, 2 participants in the experimental group dropped out for personal reasons before starting the intervention. Finally, 46 participants were included in the intention-to-treat analysis. The experimental group showed more positive changes in the healthy lifestyle score (β=29.23; P≤.001), level of each MetS component (fasting blood sugar: β=−12.0; P=.05 and abdominal circumference: β=−2.49; P=.049), body composition (body weight: β=−1.52; P<.001 and BMI: β=−0.55; P<.001), and the urinary irritative and obstructive domain of health-related quality of life (β=14.63; P<.001) over time than the waitlist control group. Conclusions: Lifestyle changes through nurse-led education can improve level of each MetS components, body composition, and ADT side effects. Nurses can induce positive changes in patients’ lifestyles and improve the self-management of patients starting ADT through this program. Trial Registration: Clinical Research Information Service KCT0006560; http://tinyurl.com/yhvj4vwh %M 38300697 %R 10.2196/47102 %U https://mhealth.jmir.org/2024/1/e47102 %U https://doi.org/10.2196/47102 %U http://www.ncbi.nlm.nih.gov/pubmed/38300697 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e43366 %T Digital Group–Based Intervention for Physical Activity Promotion Among Thai Adults During the COVID-19 Lockdown: Randomized Controlled Trial %A Pomkai,Nanthawan %A Katewongsa,Piyawat %A Chamratrithirong,Aphichat %A Tharawan,Kanokwan %A Sakulsri,Teeranong %A Samutachak,Bhubate %A Widyastari,Dyah Anantalia %A Rasri,Niramon %A Wijarn,Boonyanuch %A Wongsawat,Yodchanan %+ Institute for Population and Social Research, Mahidol University, Salaya Campus, 999 Phutthamonthon 4 Road, Nakhon Pathom, 73170, Thailand, 66 875459998, piyawat.kat@mahidol.edu %K physical activity %K digital group–based activity %K collective action %K Thai adults %K COVID-19 pandemic %K COVID-19 %K design %K model %K effectiveness %K digital %K Thailand %K behavior %D 2024 %7 31.1.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: The COVID-19 pandemic significantly diminished the physical activity (PA) level of Thai adults belonging to Generation Y (Gen Y). As a response to the global crisis, many individuals worldwide have turned to social community platforms, recognizing their potential in promoting PA during the pandemic. Gen Y, in particular, demonstrates exceptional proficiency in using social media platforms, showcasing a remarkable aptitude for swiftly accessing new information and knowledge. However, their proclivity for reckless behavior exposes them to various health risks, potentially leading to enduring adverse health consequences. Consequently, there arises a pressing need to develop a comprehensive model aimed at elevating the PA levels among individuals belonging to Gen Y. Objective: This research aimed to examine the effectiveness of a digital group–based activity in promoting PA among Gen Y in Thailand. Methods: This was a parallel 2-arm randomized controlled trial with single-blind allocation to experimental and control groups and pre- and posttest measurements. Measurements were administered on the web and were designed for respondents to complete by themselves. The sample comprised 100 Gen Y individuals who met the inclusion criteria. Both groups were matched for background characteristics. The two 8-week intervention activities were (1) two weeks of education and (2) six weeks of motivation by target groups that set goals for PA together (using the Zoom meeting application), with a time limit and group consensus as to when the goal was to be achieved. The intervention activities were implemented one by one at specified intervals and delivered daily through health apps and the official LINE account. Results: The intervention starts from August 22 to October 16, 2021. Of the 100 participants, 20 (20%) left the study, and the remaining 80 (80%) participated in the study (40 individuals each in the experimental and control groups). After participating in the experiment, a statistically significant difference in PA was found between the 2 groups (moderate to vigorous PA; 25/40, 63%; P=.03). Participants in the intervention group collected a higher cumulative minute of moderate to vigorous PA weekly (283 minutes) than those in the control group (164 minutes), and this was statistically significant (P=.03). For the transition to the fourth stage of behavior (ie, action), the improvement in the experimental group, after participating in the trial, was statistically significant compared to that of the control group (P=.01). Conclusions: Digital group–based activity showed its effectiveness in improving the PA of Gen Y individuals in the intervention group. It created a process-based intervention activity that corresponds to the stages of behavior changes, from contemplation to action. The digital community can also connect individuals to comparable groups locally and globally. Trial Registration: Thai Clinical Trials Registry TCTR20211101005; https://www.thaiclinicaltrials.org/show/TCTR20211101005 %M 38294853 %R 10.2196/43366 %U https://www.jmir.org/2024/1/e43366 %U https://doi.org/10.2196/43366 %U http://www.ncbi.nlm.nih.gov/pubmed/38294853 %0 Journal Article %@ 2369-3762 %I JMIR Publications %V 10 %N %P e49551 %T Unpacking the Experiences of Health Care Professionals About the Web-Based Building Resilience At Work Program During the COVID-19 Pandemic: Framework Analysis %A Ang,Wei How Darryl %A Lim,Zhi Qi Grace %A Lau,Siew Tiang %A Dong,Jie %A Lau,Ying %+ The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Room 829, 8/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, China (Hong Kong), 852 39436222, yinglau@cuhk.edu.hk %K resilience %K intent to stay %K employability %K health care professionals %K process evaluation %K framework analysis %K framework %K resilience %K stress %K mental health disorder %K prevention %K training %K qualitative study %K web-based tool %K tool %K sustainability %D 2024 %7 31.1.2024 %9 Original Paper %J JMIR Med Educ %G English %X Background: The COVID-19 pandemic has resulted in a greater workload in the health care system. Therefore, health care professionals (HCPs) continue to experience high levels of stress, resulting in mental health disorders. From a preventive perspective, building resilience has been associated with reduced stress and mental health disorders and promotes HCPs’ intent to stay. Despite the benefits of resilience training, few studies provided an in-depth understanding of the contextual factors, implementation, and mechanisms of impact that influences the sustainability of resilience programs. Therefore, examining target users’ experiences of the resilience program is important. This will provide meaningful information to refine and improve future resilience programs. Objective: This qualitative study aims to explore HCPs’ experiences of participating in the web-based Building Resilience At Work (BRAW) program. In particular, this study aims to explore the contextual and implementational factors that would influence participants’ interaction and outcome from the program. Methods: A descriptive qualitative approach using individual semistructured Zoom interviews was conducted with participants of the web-based resilience program. A framework analysis was conducted, and it is guided by the process evaluation framework. Results: A total of 33 HCPs participated in this qualitative study. Three themes depicting participants’ experiences, interactions, and impacts from the BRAW program were elucidated from the framework analysis: learning from web-based tools, interacting with the BRAW program, and promoting participants’ workforce readiness. Conclusions: Findings show that a web-based asynchronous and self-paced resilience program is an acceptable and feasible approach for HCPs. The program also led to encouraging findings on participants’ resilience, intent to stay, and employability. However, continued refinements in the components of the web-based resilience program should be carried out to ensure the sustainability of this intervention. Trial Registration: ClinicalTrials.gov NCT05130879; https://clinicaltrials.gov/ct2/show/NCT05130879 %M 38294866 %R 10.2196/49551 %U https://mededu.jmir.org/2024/1/e49551 %U https://doi.org/10.2196/49551 %U http://www.ncbi.nlm.nih.gov/pubmed/38294866 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e54253 %T Improvements in Adolescents’ Disordered Eating Behaviors in a Collaborative Care Digital Mental Health Intervention: Retrospective Observational Study %A Huffman,Landry Goodgame %A Lawrence-Sidebottom,Darian %A Beam,Aislinn Brenna %A Parikh,Amit %A Guerra,Rachael %A Roots,Monika %A Huberty,Jennifer %+ Bend Health Inc, 2810 Marshall Ct, Madison, WI, 53705, United States, 1 8005160975, darian.lawrence@bendhealth.com %K behavioral care %K mental health %K web-based coaching %K web-based therapy %K eating disorders %K eating %K anorexia %K coach %K coaching %K pediatric %K pediatrics %K adolescent %K adolescents %K teen %K teens %K teenager %K teenagers %K digital mental health intervention %K DMHI %K collaborative %K digital health %D 2024 %7 31.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Young people today are exhibiting increasing rates of disordered eating behaviors, as well as eating disorders (EDs), alongside other mental and behavioral problems such as anxiety and depression. However, limited access to mental health care means that EDs, disordered eating behaviors, and comorbid mental health problems are often underdiagnosed and undertreated. Digital mental health interventions (DMHIs) offer accessible and scalable alternatives to traditional treatment modalities, but their effectiveness has not been well established among adolescents with EDs and disordered eating behaviors. Objective: This study uses data from a collaborative care pediatric DMHI to determine whether participation in a DMHI is associated with a reduction in adolescents’ disordered eating behaviors. Methods: Adolescent members in care with Bend Health Inc completed the SCOFF questionnaire at baseline (before the start of care) and approximately every month during care to assess disordered eating behaviors. They also completed assessments of mental health symptoms at baseline. Member characteristics, mental health symptoms, and disordered eating behaviors of adolescents with elevated SCOFF scores at baseline (before the start of care) were compared to those of adolescents with nonelevated SCOFF scores at baseline. Members participated in web-based coaching or therapy sessions throughout the duration of mental health care. Results: Compared to adolescents with nonelevated SCOFF scores (n=520), adolescents with elevated SCOFF scores (n=169) were predominantly female and exhibited higher rates of elevated anxiety and depressive symptoms. SCOFF scores decreased over time in care with the DMHI for 61.4% (n=70) of adolescents with elevated SCOFF scores, and each additional month of participation was associated with greater improvements in disordered eating behaviors (F1,233=72.82; P<.001). Conclusions: Our findings offer promising preliminary evidence that participation in mental health care with a collaborative care DMHI may be beneficial in the reduction of disordered eating symptoms in adolescents, including those who are experiencing comorbid anxiety and depressive symptoms. %M 38294855 %R 10.2196/54253 %U https://formative.jmir.org/2024/1/e54253 %U https://doi.org/10.2196/54253 %U http://www.ncbi.nlm.nih.gov/pubmed/38294855 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e51571 %T Investigating the Potential of a Conversational Agent (Phyllis) to Support Adolescent Health and Overcome Barriers to Physical Activity: Co-Design Study %A Moore,Richard %A Al-Tamimi,Abdel-Karim %A Freeman,Elizabeth %+ Sheffield Hallam University, Sport and Physical Activity Research Centre / Advanced Wellbeing Research Centre, Sheffield Hallam University, Olympic Legacy Park, 2 Old Hall Road, Advanced Wellbeing Research Centre, Sheffield, S9 3TU, United Kingdom, 44 7751234185, r.moore@shu.ac.uk %K physical activity %K inactivity %K conversational agent %K CA %K adolescent %K public health %K digital health interventions %K mobile phone %D 2024 %7 31.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Conversational agents (CAs) are a promising solution to support people in improving physical activity (PA) behaviors. However, there is a lack of CAs targeted at adolescents that aim to provide support to overcome barriers to PA. This study reports the results of the co-design, development, and evaluation of a prototype CA called “Phyllis” to support adolescents in overcoming barriers to PA with the aim of improving PA behaviors. The study presents one of the first theory-driven CAs that use existing research, a theoretical framework, and a behavior change model. Objective: The aim of the study is to use a mixed methods approach to investigate the potential of a CA to support adolescents in overcoming barriers to PA and enhance their confidence and motivation to engage in PA. Methods: The methodology involved co-designing with 8 adolescents to create a relational and persuasive CA with a suitable persona and dialogue. The CA was evaluated to determine its acceptability, usability, and effectiveness, with 46 adolescents participating in the study via a web-based survey. Results: The co-design participants were students aged 11 to 13 years, with a sex distribution of 56% (5/9) female and 44% (4/9) male, representing diverse ethnic backgrounds. Participants reported 37 specific barriers to PA, and the most common barriers included a “lack of confidence,” “fear of failure,” and a “lack of motivation.” The CA’s persona, named “Phyllis,” was co-designed with input from the students, reflecting their preferences for a friendly, understanding, and intelligent personality. Users engaged in 61 conversations with Phyllis and reported a positive user experience, and 73% of them expressed a definite intention to use the fully functional CA in the future, with a net promoter score indicating a high likelihood of recommendation. Phyllis also performed well, being able to recognize a range of different barriers to PA. The CA’s persuasive capacity was evaluated in modules focusing on confidence and motivation, with a significant increase in students’ agreement in feeling confident and motivated to engage in PA after interacting with Phyllis. Adolescents also expect to have a personalized experience and be able to personalize all aspects of the CA. Conclusions: The results showed high acceptability and a positive user experience, indicating the CA’s potential. Promising outcomes were observed, with increasing confidence and motivation for PA. Further research and development are needed to create further interventions to address other barriers to PA and assess long-term behavior change. Addressing concerns regarding bias and privacy is crucial for achieving acceptability in the future. The CA’s potential extends to health care systems and multimodal support, providing valuable insights for designing digital health interventions including tackling global inactivity issues among adolescents. %M 38294857 %R 10.2196/51571 %U https://formative.jmir.org/2024/1/e51571 %U https://doi.org/10.2196/51571 %U http://www.ncbi.nlm.nih.gov/pubmed/38294857 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e43286 %T Formative Evaluation of a Comprehensive Self-Management Intervention for Irritable Bowel Syndrome, Comorbid Anxiety, and Depression: Mixed Methods Study %A Kamp,Kendra %A Yang,Pei-Lin %A Friedman,Emily %A Lopez,Alejandra %A Iribarren,Sarah %A Barney,Pamela %A Munson,Sean %A Heitkemper,Margaret %A Levy,Rona %+ Department of Biobehavioral Nursing and Health Informatics, School of Nursing, University of Washington, 1410 NE Campus Parkway, Seattle, WA, 98195, United States, 1 206 221 4617, kamp@uw.edu %K acceptability %K anxiety %K depression %K design %K effectiveness %K feasibility %K implementation %K intervention %K irritable bowel syndrome %K management %K mixed methods %K patient %K self-management %K support %K usability %D 2024 %7 31.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Irritable bowel syndrome (IBS) is a disorder of the gut-brain interaction that is associated with abdominal pain, altered bowel patterns, and reduced quality of life. Up to 50% of patients with IBS also report anxiety or depressive symptoms. Although effective self-management interventions exist for individuals with IBS, few have been effectively implemented, and most do not consider the unique needs of patients with comorbid IBS and anxiety or depression. Objective: This study aimed to determine the anticipated acceptability, appropriateness, feasibility, and usability of a comprehensive self-management intervention using an implementation science and human-centered design approach among individuals with comorbid IBS and anxiety or depression and health care providers. Methods: A convergent mixed methods design was used to elicit feedback on the comprehensive self-management intervention outline and content to identify refinement needs before testing. Patients with IBS and moderate to severe anxiety or depression and health care providers were purposefully sampled from primary care and gastroenterology settings. Participants completed semistructured interviews and surveys on anticipated acceptability, appropriateness, feasibility, and usability. Results: Patient participants (n=12) were on average 36.8 (SD 12.2) years of age, and 42% (5/12) were currently receiving psychological therapy. Health care providers (n=14) were from primary care (n=7) and gastroenterology (n=7) settings. The mean usability scores (out of 100) were 52.5 (SD 14.5) for patients and 45.6 (SD 11.6) for providers. For patients and providers, qualitative data expanded the quantitative findings for acceptability and appropriateness. Acceptability findings were the comprehensive nature of the intervention and discussion of the gut-brain interaction. For appropriateness, participants reported that the intervention provided structure, accountability, and support. Feasibility was confirmed for patients, but there was a divergence of findings between quantitative and qualitative measures for providers. Patients focused on intervention feasibility, while providers focused on implementation feasibility in the clinic. Identified usability issues to address before implementation included the intervention delivery format, length, and lack of integration into health care settings that, if not addressed, may limit the reach of the intervention. Conclusions: Patients and health care providers found the intervention acceptable and appropriate. Several feasibility and usability issues were identified, including intervention delivery methods, length of intervention, and the best methods to implement in the clinic setting. The next steps are to refine the intervention to address the identified issues and test in a pilot study whether addressing usability issues leads to the anticipated improvements in implementation and uptake. %M 38294871 %R 10.2196/43286 %U https://formative.jmir.org/2024/1/e43286 %U https://doi.org/10.2196/43286 %U http://www.ncbi.nlm.nih.gov/pubmed/38294871 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e48313 %T Web-Based Intervention to Act for Weight Loss in Adults With Type 2 Diabetes With Obesity (Chance2Act): Protocol for a Nonrandomized Controlled Trial %A Mohd Saad,Noraini %A Mohamad,Mariam %A Mat Ruzlin,Aimi Nadira %+ Faculty of Medicine, Universiti Teknologi MARA, Sungai Buloh Campus, Jalan Hospital, Sungai Buloh, Selangor, 47000, Malaysia, 60 361267176, mariammd@uitm.edu.my %K readiness to change %K behavior change %K diabetes %K overweight %K weight reduction %K eHealth %K obesity %D 2024 %7 31.1.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: In adults with type 2 diabetes (T2D), weight loss can improve hemoglobin A1c, blood pressure, and triglycerides, and reduce the frequency of medications needed. Unfortunately, a large proportion of these individuals are not ready to initiate weight efforts, making existing obesity management strategies less effective. Many digital health interventions aim at weight loss, but there is still limited evidence on their effectiveness in changing weight loss behavior, especially in adults with T2D. Objective: This study aims to develop and validate “Chance2Act,” a new web-based intervention, designed specifically to facilitate behavioral change in adults with T2D with obesity who are not ready to act toward weight loss. Then, the effectiveness of the newly developed intervention will be determined from a nonrandomized controlled trial. Methods: A web-based intervention will be developed based on the Transtheoretical Model targeting adults with T2D with obesity who are not ready to change for weight loss. Phase 1 will involve the development and validation of the web-based health intervention module. In phase 2, a nonrandomized controlled trial will be conducted in 2 government health clinics selected by the investigator. This is an unblinded study with a parallel assignment (ie, intervention vs control [usual care] with an allocation ratio of 1:1). A total of 124 study participants will be recruited, of which 62 participants will receive the Chance2Act intervention in addition to the usual care. The primary outcome is the changes in an individual’s readiness from a stage of not being ready to change (precontemplation, contemplation, or preparation stage) to being ready for weight loss (action stage). The secondary outcomes include changes in self-efficacy, decisional balance, family support for weight loss, BMI, waist circumference, and body fat composition. Results: The phase 1 study will reveal the intervention’s validity through the Content Validity Index and Face Validity Index, considering it valid if both indices exceed 0.83. The effectiveness of the intervention will be determined in phase 2, where the differences within and between groups will be analyzed in terms of the improvement of stages of change and all secondary outcomes as defined in the methodology. Data analysis for phase 2 will commence in 2024, with the anticipated publication of results in March 2024. Conclusions: If proven effective, the result of the study may give valuable insights into the effective behavioral modification strategies for a web-based intervention targeting adults with T2D with obesity but not yet ready to change for weight loss. This intervention may be replicated or adopted in different settings, focusing on behavioral modification support that patients need. This study offers a deeper understanding of the application of behavior change techniques for a more holistic approach to obesity care in T2D. Trial Registration: ClinicalTrials.gov NCT05736536; https://clinicaltrials.gov/study/NCT05736536 International Registered Report Identifier (IRRID): DERR1-10.2196/48313 %M 38294848 %R 10.2196/48313 %U https://www.researchprotocols.org/2024/1/e48313 %U https://doi.org/10.2196/48313 %U http://www.ncbi.nlm.nih.gov/pubmed/38294848 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e47908 %T Examining the Effect of Contactless Intergenerational Befriending Intervention on Social Isolation Among Older Adults and Students’ Attitude Toward Companionship: Content Analysis %A Sen,Keya %A Laheji,Nida %A Ramamonjiarivelo,Zo %A Renick,Cecil %A Osborne,Randall %A Beauvais,Brad %+ School of Health Administration, Texas State University, 601 University Drive, San Marcos, TX, 78666, United States, 1 512 245 3508, Keyasen@txstate.edu %K intergenerational befriending %K social isolation %K boredom %K contactless socialization %K service learning %K internal motivation %K mobile phone %D 2024 %7 30.1.2024 %9 Original Paper %J JMIR Aging %G English %X Background: Intergenerational friendship, a mechanism of social support, is an effective intervention to reduce the increasing risk of social isolation (SI) and develop companionship in the older adult population. The COVID-19 pandemic provided a unique opportunity to examine the psychosocial intervention of befriending via technology use as a primary form of contactless socialization. Objective: The study aims to explore the effectiveness of the befriending intervention through a contactless, intergenerational service-learning project on older adult emotions, especially boredom and loneliness as the key attributes of SI, and on students’ attitude toward companionship. Methods: During the months of January to April 2022 , undergraduate students enrolled in a health administration course with a special focus on culture were asked to be involved in a contactless, intergenerational service-learning project (n=46). In this study, contactless intervention meant communication using the telephone and apps such as FaceTime and Zoom. Students were paired with older adults to have at least a 30-minute weekly conversation, for 8 weeks, via telephone or an internet-based app such as FaceTime. Students were asked to write a half-page diary after each interaction and a 1-page reflection at the end of the fourth week and at the end of the service-learning project. At the completion of the project, the researchers also surveyed the older adults to assess the impact of the project using a 5-item open-ended questionnaire. Following a heuristic approach and content analysis, student artifacts (110,970 words; 118-page, single-spaced Microsoft Word document) and the older adult surveys were analyzed using MAXQDA, (VERBI GmbH). Qualitative data were extracted to assess the impact of service learning on SI by measuring the attributes of boredom and loneliness among 46 older adults. Students’ attitudes toward companionship were also assessed using data from their diaries and reflections. Results: Overall, three major constructs were identified: (1) meaningful engagement, defined as feeling safe, having increased confidence, and having reduced boredom; (2) internal motivation to participate in the weekly interaction, defined as discussion about daily life experience, level of happiness, and ability to exert personal control over the situation; and (3) intergenerational befriending, defined as perceived benefits from the friendly nature of the interaction, ability to comfortably connect with students, and positive feeling and attitude toward the student. Conclusions: The contactless, intergenerational befriending intervention reduced boredom and loneliness among older adults and enhanced positive attitude and confidence among university students. Students helped older adults to develop digital skills for the use of apps and social media. Older adults showed interest in the intervention and shared their daily life experiences with the students, which helped to reduce the gap between generations. Findings indicate the effectiveness of an intergenerational service-learning intervention on SI reduction and increased positive attitude among college students. %M 38175944 %R 10.2196/47908 %U https://aging.jmir.org/2024/1/e47908 %U https://doi.org/10.2196/47908 %U http://www.ncbi.nlm.nih.gov/pubmed/38175944 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e54132 %T Web-Based Mindfulness Meditation as an Adjunct to Internet-Delivered Cognitive Behavioral Therapy for Public Safety Personnel: Mixed Methods Feasibility Evaluation Study %A Landry,Caeleigh A %A McCall,Hugh C %A Beahm,Janine D %A Titov,Nickolai %A Dear,Blake %A Carleton,R Nicholas %A Hadjistavropoulos,Heather D %+ Department of Psychology, University of Regina, Administration-Humanities, AH 345, 3737 Wascana Parkway, Regina, SK, S4S 0A2, Canada, 1 306 585 5133, heather.hadjistavropoulos@uregina.ca %K public safety personnel %K PSP %K internet therapy %K mindfulness %K meditation %K internet-delivered cognitive behavioral therapy %K iCBT %D 2024 %7 30.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Public safety personnel (PSP) are individuals who work to ensure the safety and security of communities (eg, correctional workers, firefighters, paramedics, and police officers). PSP have a high risk of developing mental disorders and face unique barriers to traditional mental health treatments. The PSP Wellbeing Course is a transdiagnostic, internet-delivered cognitive behavioral therapy (iCBT) course tailored to assist PSP with symptoms of depression, anxiety, and posttraumatic stress disorder (PTSD). The initial course outcomes are promising, but some clients report some challenges with learning skills and recommend adding additional resources. Mindfulness meditations, which help people to experience the world and their reactions to the world in open and nonjudgmental ways, may complement the existing PSP Wellbeing Course. Objective: This study aims to examine the feasibility of mindfulness meditations in iCBT tailored for PSP. Information was gathered to evaluate engagement and client experiences with mindfulness meditations, symptom change, and the relationship between mindfulness meditation use and symptom change. Methods: A mixed methods study was conducted on PSP enrolled in the PSP Wellbeing Course who were offered 5 mindfulness meditations during the program (ie, 1/lesson). Clients completed questionnaires on depression, anxiety, PTSD, anger, insomnia, resilience, and mindfulness at pretreatment and at 8 weeks; an 8-week treatment satisfaction questionnaire; and brief weekly measures of mindfulness meditation engagement. We used paired sample t tests (2-tailed) to assess changes in outcomes over time and partial correlations to assess whether mindfulness meditation use predicted outcomes at posttreatment. A total of 12 clients were interviewed about their perceptions of the mindfulness meditations, and interviews were analyzed using directed content analysis. Results: Among the 40 clients enrolled, 27 (68%) reported using the mindfulness meditations, practicing for an average of 4.8 (SD 8.1) minutes each week. Most interviewees described the mindfulness meditations as beneficial but also reported challenges, such as discomfort while sitting with their feelings. Clients provided suggestions for better integration of mindfulness into iCBT. Overall, clients who completed the PSP Wellbeing Course with mindfulness meditations experienced statistically significant improvements in symptoms of anxiety (P=.001), depression (P=.001), PTSD (P=.001), and anger (P=.001) but not insomnia (P=.02). Clients also experienced improvements in resilience (P=.01) and mindfulness (P=.001). Self-reported time spent meditating was not associated with changes in symptoms over time. Conclusions: This study provides new insight into the integration of mindfulness meditations with iCBT for PSP. It demonstrates the partial feasibility of adding mindfulness meditations to iCBT, revealing that some, but not all, PSP engaged with the meditations and reported benefits. PSP reported using the mindfulness meditations inconsistently and described challenges with the meditations. Improvements can be made to better integrate mindfulness meditation into iCBT, including offering mindfulness meditation as an optional resource, providing more psychoeducation on managing challenges, and offering shorter meditations. %M 38289655 %R 10.2196/54132 %U https://formative.jmir.org/2024/1/e54132 %U https://doi.org/10.2196/54132 %U http://www.ncbi.nlm.nih.gov/pubmed/38289655 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e53439 %T Administrative Dashboard for Monitoring Use of a Web-Based Parent Training Intervention: Usability Study %A Breitenstein,Susan M %A Berteletti,Julia %A Smoske,Shea %A Barger,Charles %A Tipps,Kyrie %A Helsabeck,Nathan P %+ College of Nursing, The Ohio State University, 1577 Neil Avenue, Columbus, OH, 43210, United States, 1 6146884614, breitenstein.5@osu.edu %K usability %K development %K dashboard %K portal %K implementation %K design %K System Usability Scale %K internet-based intervention %K parents %K parent %K child %K children %K web-based %K web-based parent training %K PT %K descriptive survey %K single group %K survey %K system usability %K ezParent %K videoconference %K information %K reviews on usage %K improvement %K qualitative %D 2024 %7 30.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Web-based parent training (PT) programs can strengthen parent-child relationships by equipping caregivers with knowledge and evidence-based strategies to manage behavior. Hybrid facilitation of PT includes facilitator interaction paired with self-administered and web-based PT. Web-based administrative dashboards provide users (eg, administrators, facilitators, and researchers) with an integrated platform to monitor parent progress and activities within a PT program or website. Despite the utility and prevalence of administrative dashboards for web-based behavioral interventions, to our knowledge, no research studies have explored the perspectives and insights of dashboard users to enhance user experience and program delivery. Objective: The purpose of this study is to evaluate the usability of the administrative dashboard (ezDashboard) for the ezParent program, a 6-module web-based PT program for parents of children aged 2-5 years. Methods: This study used a descriptive, single-group design with administrators who were overseeing the implementation of the ezParent program and trained facilitators for hybrid ezParent delivery. Participants spent at least 30 minutes reviewing and evaluating the ezDashboard and then completed a survey of their experience with the dashboard. The survey included the validated 10-item System Usability Scale and open-ended questions focusing on user performance, navigation ease, and overall usefulness of the ezDashboard. Results: Participants (N=15) indicated high usability of the ezDashboard with System Usability Scale scoring a total mean score of 83.5 (SD 16.3). Most participants (n=13, 87%) rated the overall user-friendliness of the ezDashboard as good (n=3, 20%), excellent (n=9, 60%), or best imaginable (n=1, 7%). Open-ended questions revealed the ezDashboard is or would be useful to monitor parent progress and trends in engagement (n=8, 53%) and for reviewing topics for discussion and communicating with parents (n=5, 33%). ezParent administrators (n=4) identified that real-time data for ezParent use helps overall management of program uptake. Suggestions for features to add to the ezDashboard included the ability to track partial progress of program modules (4/14, 29%), total time spent per module (2/14, 14%), and exportable reports (4/14, 29%). Other ideas for improvement included direct messaging capabilities, videoconferencing platform integration, and being able to modify participant account and contact information. Conclusions: Results indicate that the ezDashboard is easy to use and provides functional information to facilitators and administrators in delivering ezParent. Qualitative results indicate that integrating suggested features into the ezDashboard may help provide a smoother experience for facilitators, administrators, and ultimately the parents using the program. Providing resources for facilitators and administrators in real time to monitor intervention participants’ progress in a program can be helpful in tracking progress and providing facilitated support in tailoring program content and program completion. %M 38289675 %R 10.2196/53439 %U https://formative.jmir.org/2024/1/e53439 %U https://doi.org/10.2196/53439 %U http://www.ncbi.nlm.nih.gov/pubmed/38289675 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e45659 %T Acceptability of a Self-Led Mindfulness-Based Intervention for Teens with Type 1 Diabetes: Pilot Randomized Controlled Trial %A Humiston,Tori %A Cummings,Caroline %A Suss,Stephen %A Cohen,Laura B %A Hazlett-Stevens,Holly %A Hughes Lansing,Amy %+ Department of Psychological Sciences, University of Vermont, 2 Colchester Ave, Burlington, VT, 05401, United States, 1 8026562670, tori.humiston@uvm.edu %K adolescents %K diabetes distress %K diabetes %K health group intervention %K intervention %K mindfulness %K psychosocial intervention %K self-led mindfulness %K type 1 diabetes %D 2024 %7 30.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Diabetes distress among adolescents with type 1 diabetes has been associated with suboptimal diabetes outcomes, including lower quality of life, increased diabetes self-management challenges, and suboptimal glycemic outcomes. Objective: This study examined the feasibility and acceptability of a scalable self-led mindfulness-based intervention to reduce diabetes distress in adolescents with type 1 diabetes. Methods: Adolescents (N=25) aged between 14 and 18 years diagnosed with type 1 diabetes completed a baseline assessment. Participants were randomized to receive a 10-week self-guided mindfulness-based stress reduction workbook program (e-book or paper option) immediately (n=15) or after a 10-week wait (n=10). During the intervention period, participants completed weekly assignments and feedback surveys. At 10 weeks and 20 weeks, follow-up assessments were completed. Results: Findings indicated that participants did not find the original intervention feasible or acceptable. Adolescents reported barriers to completing the weekly material, such as that they forgot or that the material was not sufficiently related to their diabetes management. Adolescents also reported that a digital format rather than a workbook or e-book may be more acceptable. Results from weekly surveys provided the foundation for recommendations for future iterations of the mindfulness-based intervention for adolescents with type 1 diabetes. Conclusions: Participant feedback informed recommendations for self-led mindfulness programs for youth with type 1 diabetes. Adolescents indicated that a shorter, digital mindfulness-based intervention focused on diabetes-specific behaviors may be more helpful. Trial Registration: ClinicalTrials.gov NCT05115175; https://clinicaltrials.gov/study/NCT05115175 %M 38289663 %R 10.2196/45659 %U https://formative.jmir.org/2024/1/e45659 %U https://doi.org/10.2196/45659 %U http://www.ncbi.nlm.nih.gov/pubmed/38289663 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e48703 %T Effectiveness of the Wellness Together Canada Portal as a Digital Mental Health Intervention in Canada: Protocol for a Randomized Controlled Trial %A Basnet,Syaron %A Chaiton,Michael %+ Centre For Addiction and Mental Health, University of Toronto, 250 College Street, Toronto, ON, M5T 1R8, Canada, 1 416 6052464, syaronbasnet@gmail.com %K Wellness Together Portal %K randomized trial %K COVID-19 %K mental health %K digital health %K digital intervention %K substance use %K portal %K effectiveness %K well-being %D 2024 %7 30.1.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The Wellness Together Canada (WTC) portal is a digital mental health intervention that was developed in response to an unprecedented rise in mental health and substance use concerns due to the COVID-19 pandemic, with funding from the Government of Canada. It is a mental health and substance use website to support people across Canada providing digital interventions and services at no cost. Two million people have visited the WTC portal over the course of 1 year since launching; however, rigorous evaluation of this potential solution to access to mental health care during and after the COVID-19 pandemic is urgently required. Objective: This study aims to better understand the effectiveness of the existing digital interventions in improving population mental health in Canada. Methods: The Let’s Act on Mental Health study is designed as a longitudinal fully remote, equally randomized (1:1), double-blind, alternative intervention–controlled, parallel-group randomized controlled trial to be conducted between October 2023 and April 2024 with a prospective follow-up study period of 26 weeks. This trial will evaluate whether a digital intervention such as the WTC improves population mental health trajectories over time. Results: The study was approved by the research ethics board of CAMH (Centre for Addiction and Mental Health, Toronto, Ontario, Canada). It is ongoing and participant recruitment is underway. As of August 2023, a total of 453 participants in the age group of 18-72 years have participated, of whom 70% (n=359) are female. Conclusions: This initiative provides a unique opportunity to match people’s specific unmet mental health and substance use needs to evidence-based digital interventions. %M 38289642 %R 10.2196/48703 %U https://www.researchprotocols.org/2024/1/e48703 %U https://doi.org/10.2196/48703 %U http://www.ncbi.nlm.nih.gov/pubmed/38289642 %0 Journal Article %@ 2291-9694 %I JMIR Publications %V 12 %N %P e42847 %T Ten Years of Experience With a Telemedicine Platform Dedicated to Health Care Personnel: Implementation Report %A Azzolini,Claudio %A Premi,Elias %A Donati,Simone %A Falco,Andrea %A Torreggiani,Aldo %A Sicurello,Francesco %A Baj,Andreina %A Azzi,Lorenzo %A Orro,Alessandro %A Porta,Giovanni %A Azzolini,Giovanna %A Sorrentino,Marco %A Melillo,Paolo %A Testa,Francesco %A Simonelli,Francesca %A Giardina,Gianfranco %A Paolucci,Umberto %+ Advisory Council of e-Health and Telemedicine, University of Insubria of Varese-Como, Via Guicciardini 9, Varese, 21100, Italy, 39 0332393603, claudio.azzolini@uninsubria.it %K telemedicine %K ophthalmology %K eHealth %K informatics platform %K health care professional %K patient care %K information technology %K data warehouse %D 2024 %7 26.1.2024 %9 Implementation Report %J JMIR Med Inform %G English %X Background: Telemedicine, a term that encompasses several applications and tasks, generally involves the remote management and treatment of patients by physicians. It is known as transversal telemedicine when practiced among health care professionals (HCPs). Objective: We describe the experience of implementing our telemedicine Eumeda platform for HCPs over the last 10 years. Methods: A web-based informatics platform was developed that had continuously updated hypertext created using advanced technology and the following features: security, data insertion, dedicated software for image analysis, and the ability to export data for statistical surveys. Customizable files called “modules” were designed and built for different fields of medicine, mainly in the ophthalmology subspecialty. Each module was used by HCPs with different authorization profiles. Implementation (Results): Twelve representative modules for different projects are presented in this manuscript. These modules evolved over time, with varying degrees of interconnectivity, including the participation of a number of centers in 19 cities across Italy. The number of HCP operators involved in each single module ranged from 6 to 114 (average 21.8, SD 28.5). Data related to 2574 participants were inserted across all the modules. The average percentage of completed text/image fields in the 12 modules was 65.7%. All modules were evaluated in terms of access, acceptability, and medical efficacy. In their final evaluation, the participants judged the modules to be useful and efficient for clinical use. Conclusions: Our results demonstrate the usefulness of the telemedicine platform for HCPs in terms of improved knowledge in medicine, patient care, scientific research, teaching, and the choice of therapies. It would be useful to start similar projects across various health care fields, considering that in the near future medicine as we know it will completely change. %M 38277199 %R 10.2196/42847 %U https://medinform.jmir.org/2024/1/e42847 %U https://doi.org/10.2196/42847 %U http://www.ncbi.nlm.nih.gov/pubmed/38277199 %0 Journal Article %@ 2373-6658 %I JMIR Publications %V 8 %N %P e49493 %T Toward Sustaining Web-Based Senior Center Programming Accessibility With and for Older Adult Immigrants: Community-Based Participatory Research Cross-Sectional Study %A Nguyen-Truong,Connie Kim Yen %A Wuestney,Katherine %A Leung,Holden %A Chiu,Chenya %A Park,Maria %A Chac,Christina %A Fritz,Roschelle Lynette %+ Nursing and Systems Science Department, College of Nursing in Vancouver, Washington State University, 14204 NE Salmon Creek Ave, Vancouver, WA, 98686-9600, United States, 1 3605469395, c.nguyen-truong@wsu.edu %K Asian American %K Chinese %K Korean %K Vietnamese %K community-based participatory research %K CBPR %K COVID-19 %K health equity %K immigrants %K older adults %K psychosocial %K technology access %K telehealth use %K web-based senior center %K mobile phone %D 2024 %7 26.1.2024 %9 Original Paper %J Asian Pac Isl Nurs J %G English %X Background: During the COVID-19 pandemic, many community-based organizations serving Asian Americans pivoted to provide web-based care and social services. Asian American community leaders in the United States Pacific Northwest, including Asian Health & Service Center expressed that there are older immigrant adults who experienced backlash from discrimination, fear, and anxiety owing in part to anti-Asian hate and isolation, including from infection precautions. Pivoting supported staying safe from COVID-19 transmission and anti-Asian hate crimes. Objective: This study aims to examine the readiness of diverse groups of older Asian American immigrant adults (Chinese, Koreans, and Vietnamese) to use a web-based senior center, including technology access and telehealth use, and to identify the psychosocial health impacts that a web-based senior center could be positioned to meet. Methods: A community-based participatory research approach was used to conduct a cross-sectional survey study in an Asian-based health and service center in 2022. We selected surveys from the National Institutes of Health–supported PhenX Toolkit. Analyses were performed using R software. Results: There was an 88.2% (216/245) response rate. Overall, 39.8% (86/216) of participants were Chinese, 25% (54/216) were Korean, and 24.5% (53/216) were Vietnamese. There were significant group differences in mobile data plans (P=.0005). Most had an unlimited mobile data plan (38/86, 44% Chinese; 39/54, 72% Koreans; 25/53, 47% Vietnamese). Significant group differences existed regarding whether they started using a new electronic device to communicate with friends or family after the COVID-19 outbreak (P=.0005); most were Korean participants (31/54, 57%). For written text and audio or video apps, most Chinese participants used WeChat (65/85, 76%; 57/84, 68%, respectively), most Koreans used KakaoTalk (49/54, 91%; 49/54, 91%, respectively), and most Vietnamese used Facebook Messenger for written text (32/50, 64%) and Apple Face Time (33/50, 66%) or Facebook Messenger (31/50, 62%) for audio or video. Significant group differences existed regarding whether to try telehealth (P=.0005); most Vietnamese expressed that they would never consider it (41/53, 77%). Significant group differences existed regarding how well they were able to concentrate (χ22=44.7; P<.0001); Chinese participants reported a greater inability (median 5, IQR 4-6). With regard to difficulties in life experiences (χ22=51; P<.0001), the median was 6 (IQR 5-7) for the Vietnamese group. Significant group differences existed in having had a family/household member’s salary, hours, and contracts reduced (P=.0005) and having had a family/household member or friend fallen physically ill (P=.0005)—most Vietnamese (15/53, 28%) and Korean participants (10/53, 19%). Conclusions: To build an efficacious, web-based senior center with web-based care and social service options, more older adults need access to the internet and education about using technology-enabled communication devices. Addressing the unique psychosocial impacts of the COVID-19 pandemic on each group could improve health equity. The strength of the participating older adults was observed and honored. %M 38277216 %R 10.2196/49493 %U https://apinj.jmir.org/2024/1/e49493 %U https://doi.org/10.2196/49493 %U http://www.ncbi.nlm.nih.gov/pubmed/38277216 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e50942 %T Designing and Developing Online Training for Diabetes Prevention Program Coaches Using an Integrated Knowledge Translation Approach: Development and Usability Study %A Cranston,Kaela D %A Grieve,Natalie J %A Dineen,Tineke E %A Jung,Mary E %+ Faculty of Health and Social Development, University of British Columbia, 1238 Discovery Road, Kelowna, BC, V1V 1V7, Canada, 1 2508079670, mary.jung@ubc.ca %K program evaluation %K prediabetic state %K e-learning education %K e-learning %K platform %K usability %K diabetes %K prevention %K knowledge translation %K end user %K type 2 diabetes %K framework %D 2024 %7 26.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: e-Learning has rapidly become a popular alternative to in-person learning due to its flexibility, convenience, and wide reach. Using a systematic and partnered process to transfer in-person training to an e-learning platform helps to ensure the training will be effective and acceptable to learners. Objective: This study aimed to develop an e-learning platform for Small Steps for Big Changes (SSBC) type 2 diabetes prevention program coaches to improve the viability of coach training. Methods: An integrated knowledge translation approach was used in the first 3 stages of the technology-enhanced learning (TEL) evaluation framework to address the study objective. This included three steps: (1) conducting a needs analysis based on focus groups with previously trained SSBC coaches, meetings with the SSBC research team, and a review of research results on the effectiveness of the previous in-person version of the training; (2) documenting processes and decisions in the design and development of the e-learning training platform; and (3) performing usability testing. Previously trained SSBC coaches and the SSBC research team were included in all stages of this study. Results: Step 1 identified components from the in-person training that should be maintained in the e-learning training (ie, a focus on motivational interviewing), additional components to be added to the e-learning training (ie, how to deliver culturally safe and inclusive care), and mode of delivery (videos and opportunities to synchronously practice skills). Step 2 documented the processes and decisions made in the design and development of the e-learning training, including the resources (ie, time and finances) used, the content of the training modules, and how coaches would flow through the training process. The design and development process consisted of creating a blueprint of the training. The training included 7 e-learning modules, the learning modalities of which included narrated demonstration videos and user-engaging activities, a mock session with feedback from the research team, and a final knowledge test. Step 3, usability testing, demonstrated high levels of learnability, efficiency, memorability, and satisfaction, with minor bugs documented and resolved. Conclusions: Using an integrated knowledge translation approach to the technology-enhanced learning evaluation framework was successful in developing an e-learning training platform for SSBC coaches. Incorporating end users in this process can increase the chances that the e-learning training platform is usable, engaging, and acceptable. Future research will include examining the satisfaction of coaches using the SSBC coach e-learning training platform, assessing coach learning outcomes (ie, knowledge and behavior), and estimating the cost and viability of implementing this training. %M 38277214 %R 10.2196/50942 %U https://formative.jmir.org/2024/1/e50942 %U https://doi.org/10.2196/50942 %U http://www.ncbi.nlm.nih.gov/pubmed/38277214 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e48880 %T Acceptance of a Web-Based Intervention in Individuals Who Committed Sexual Offenses Against Children: Cross-Sectional Study %A Schröder,Sonja %A Buntrock,Claudia %A Neumann,Louisa %A Müller,Jürgen L %A Fromberger,Peter %+ Clinic for Psychiatry and Psychotherapy – Forensic Psychiatry, University Medical Center Göttingen, Rosdorfer Weg 70, Göttingen, 37081, Germany, 49 5514022114, sonja.schroeder@med.uni-goettingen.de %K mHealth %K web-based intervention %K acceptance %K Unified Theory of Acceptance and Use of Technology %K UTAUT %K sexual offenses against children %K child abuse %K child pornography %K children %K sexual offense %K cross-sectional study %K community %K anxiety %K psychiatry %D 2024 %7 26.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Individuals who have committed sexual offenses against children often have difficulties finding treatment, despite its potential effectiveness. Although the development of web-based interventions could enhance therapeutic supply, up to now the acceptance thereof among this target group is unknown. Objective: For the first time, this study assesses the acceptance of a web-based intervention among individuals who committed sexual offenses against children and analyzes variables that predict acceptance. Following the Unified Theory of Acceptance and Use of Technology (UTAUT), it is assumed that acceptance of web-based interventions in individuals who have committed sexual offenses against children follows the same mechanisms as for individuals in general psychiatry. Methods: This cross-sectional study is based on the data from an ongoing clinical trial (@myTabu) evaluating the effectiveness of a web-based intervention in individuals who committed sexual offenses against children (N=113). Acceptance level was measured using a questionnaire based on the UTAUT and modified for the target group. Furthermore, predictors of acceptance from the UTAUT (performance expectancy, effort expectancy, and social influence [SI]), attitudes toward web-based interventions, and internet anxiety were assessed at baseline. Results: Most participants (61.1%, 69/113), reported high acceptance, while 36.3% (41/113) of them indicated moderate acceptance, and 2.7% (3/113) of them expressed low acceptance. In a linear regression model, the predictors explained 41.2% of the variance (F11,101=9.055; P=.01). Attitudes toward web-based interventions (B=0.398, 95% CI 0.16-0.64; P=.001) and SI (B=0.183, 95% CI 0.03-0.38; P=.04) significantly predicted acceptance. Post hoc explorative analysis showed that the participants’ belief that people close to them would recommend the use of a web-based intervention is a predictor of acceptance. In contrast, the belief that their community supervisor would recommend the use thereof was not predictive in this respect. Conclusions: For the participants of this study, we identified high acceptance of web-based interventions for the majority of participants. SI and the participants’ attitudes toward web-based interventions were important in predicting acceptance. Trial Registration: German Clinical Trial Registration (DRKS, Deutsches Register Klinischer Studien) DRKS 00021256; https://drks.de/search/de/trial/DRKS00021256 %M 38277200 %R 10.2196/48880 %U https://formative.jmir.org/2024/1/e48880 %U https://doi.org/10.2196/48880 %U http://www.ncbi.nlm.nih.gov/pubmed/38277200 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e44029 %T Testing a Behavioral Activation Gaming App for Depression During Pregnancy: Multimethod Pilot Study %A Vanderkruik,Rachel C %A Ferguson,Craig %A Kobylski,Lauren A %A Locascio,Joseph J %A Hamlett,Gabriella E %A Killenberg,Parker C %A Lewis,Robert %A Jones,Noah %A Rossa,Ella T %A Dineen,Hannah %A Picard,Rosalind %A Cohen,Lee S %+ Center for Women's Mental Health, Massachusetts General Hospital, 185 Cambridge St, Ste 2200, Boston, MA, 02114, United States, 1 781 691 9071, rvanderkruik@mgh.harvard.edu %K perinatal depression %K pregnancy %K behavioral activation %K mobile app %K digital intervention %K mobile phone %D 2024 %7 26.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Depression during pregnancy is increasingly recognized as a worldwide public health problem. If untreated, there can be detrimental outcomes for the mother and child. Anxiety is also often comorbid with depression. Although effective treatments exist, most women do not receive treatment. Technology is a mechanism to increase access to and engagement in mental health services. Objective: The Guardians is a mobile app, grounded in behavioral activation principles, which seeks to leverage mobile game mechanics and in-game rewards to encourage user engagement. This study seeks to assess app satisfaction and engagement and to explore changes in clinical symptoms of depression and anxiety among a sample of pregnant women with elevated depressive symptoms. Methods: This multimethod pilot test consisted of a single-arm, proof-of-concept trial to examine the feasibility and acceptability of The Guardians among a pregnant sample with depression (N=18). Participation included two web-based study visits: (1) a baseline assessment to collect demographic and obstetric information and to assess clinical symptoms and (2) an exit interview to administer follow-up measures and explore user experience. Participants completed biweekly questionnaires (ie, Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7) during the trial to assess depression and anxiety symptom severity. App satisfaction was measured using 2 self-report scales (ie, Mobile Application Rating Scale and Player Experience of Needs Satisfaction scale). Engagement with The Guardians was captured using game interaction metric data. We used backward-eliminated mixed effects longitudinal models to examine the effects of app engagement and satisfaction and length of time in the study on symptoms of depression and anxiety. Content analysis was conducted on qualitative data from exit interviews. Results: The 15-day and 30-day overall app retention rates were 26.6% and 15.1%, respectively. Mixed effects models found significant negative main effects of week in study (β=−.35; t61=−3.05; P=.003), number of activities completed (β=−.12; t61=−2.05; P=.04), days played (β=−.12; t58=−2.9; P=.005), and satisfaction, according to the Mobile Application Rating Scale (β=−3.05; t45=−2.19; P=.03) on depressive symptoms. We have reported about similar analyses for anxiety. There is preliminary evidence suggesting harder activities are associated with greater mood improvement than easier activities. Qualitative content analysis resulted in feedback falling under the following themes: activities, app design, engagement, fit of the app with lifestyle, perceived impact of the app on mood, and suggestions for app modifications. Conclusions: Preliminary results from this multimethod study of The Guardians indicate feasibility and acceptability among pregnant women with depression. Retention and engagement levels were more than double those of previous public mental health apps, and use of the app was associated with significant decrease in depressive symptom scores over the 10-week trial. The Guardians shows promise as an effective and scalable digital intervention to support women experiencing depression. %M 38277191 %R 10.2196/44029 %U https://formative.jmir.org/2024/1/e44029 %U https://doi.org/10.2196/44029 %U http://www.ncbi.nlm.nih.gov/pubmed/38277191 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e51544 %T The Implementation Success of Technology-Based Counseling in Dementia Care: Scoping Review %A Bauernschmidt,Dorothee %A Wittmann,Janina %A Hirt,Julian %A Meyer,Gabriele %A Bieber,Anja %+ Institute of Health and Nursing Science, University Medicine Halle, Martin Luther University Halle-Wittenberg, Magdeburger Straße 8, Halle (Saale), 06112, Germany, 49 345 557 4427, anja.bieber@uk-halle.de %K implementation success %K implementation outcomes %K counseling %K technology %K dementia %D 2024 %7 25.1.2024 %9 Review %J JMIR Aging %G English %X Background: Implementing technology-based counseling as a complex intervention in dementia care poses challenges such as adaptation to stakeholders’ needs and limited resources. While studies have examined the effectiveness of technology-based counseling, its successful implementation remains largely unexplored. Objective: We aimed to review the knowledge about the implementation success of technology-based counseling interventions for people with dementia and their informal caregivers. Methods: We conducted a scoping review and systematically searched CINAHL, the Cochrane Library including the Cochrane Central Register of Controlled Trials, MEDLINE, PsycINFO, and Web of Science Core Collection databases (April 2021) in combination with citation searching and web searching (November 2021). Studies reporting on technology-based counseling interventions for people with dementia or their informal caregivers were included, irrespective of the design. We used the conceptual framework for implementation outcomes to operationalize implementation success and applied the outcomes acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability as categories to inform data extraction. We identified dimensions within the categories and synthesized results narratively and graphically. Results: We included 52 publications reporting on 27 technology-based counseling interventions. The studies were conducted in 9 countries and published between 1993 and 2021. As the design of the included studies varied, the number of participants and the type of data reported varied as well. The intervention programs were heterogeneous and ranged from single counseling interventions (such as helpline services) to counseling as part of a multicomponent program. Telephone, email, videoconferencing, social media (respectively chats), and web-based platforms were used for delivering counseling. We found data on appropriateness for all interventions and data on acceptability for most interventions, describing aspects such as consumer-perceived usefulness and helpfulness of services, as well as satisfaction. Information on the other categories of adoption, feasibility, fidelity, implementation cost, penetration, and sustainability was fragmented. Conclusions: The scope and depth of information on conceptual categories of the implementation success of technology-based counseling for people with dementia and informal caregivers varied. The data only partially covered the concept of implementation success, which highlights the need for a systematic evaluation accompanying the implementation. The application of theoretical approaches for implementation and adherence to the framework for developing and evaluating complex interventions are required to promote the implementation of complex interventions and to comprehensively assess implementation success. Trial Registration: PROSPERO CRD42021245473; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=245473 %M 38271050 %R 10.2196/51544 %U https://aging.jmir.org/2024/1/e51544 %U https://doi.org/10.2196/51544 %U http://www.ncbi.nlm.nih.gov/pubmed/38271050 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e50132 %T Development and Evaluation of a Smartphone-Based Chatbot Coach to Facilitate a Balanced Lifestyle in Individuals With Headaches (BalanceUP App): Randomized Controlled Trial %A Ulrich,Sandra %A Gantenbein,Andreas R %A Zuber,Viktor %A Von Wyl,Agnes %A Kowatsch,Tobias %A Künzli,Hansjörg %+ School of Applied Psychology, Zurich University of Applied Sciences, Pfingstweidstrasse 96, 2, Zurich, 8005, Switzerland, 41 58 934 ext 8451, sandra.ulrich@zhaw.ch %K chatbot %K mobile health %K mHealth %K smartphone %K headache management %K psychoeducation %K behavior change %K stress management %K mental well-being %K lifestyle %K mindfulness %K relaxation %K mobile phone %D 2024 %7 24.1.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Primary headaches, including migraine and tension-type headaches, are widespread and have a social, physical, mental, and economic impact. Among the key components of treatment are behavior interventions such as lifestyle modification. Scalable conversational agents (CAs) have the potential to deliver behavior interventions at a low threshold. To our knowledge, there is no evidence of behavioral interventions delivered by CAs for the treatment of headaches. Objective: This study has 2 aims. The first aim was to develop and test a smartphone-based coaching intervention (BalanceUP) for people experiencing frequent headaches, delivered by a CA and designed to improve mental well-being using various behavior change techniques. The second aim was to evaluate the effectiveness of BalanceUP by comparing the intervention and waitlist control groups and assess the engagement and acceptance of participants using BalanceUP. Methods: In an unblinded randomized controlled trial, adults with frequent headaches were recruited on the web and in collaboration with experts and allocated to either a CA intervention (BalanceUP) or a control condition. The effects of the treatment on changes in the primary outcome of the study, that is, mental well-being (as measured by the Patient Health Questionnaire Anxiety and Depression Scale), and secondary outcomes (eg, psychosomatic symptoms, stress, headache-related self-efficacy, intention to change behavior, presenteeism and absenteeism, and pain coping) were analyzed using linear mixed models and Cohen d. Primary and secondary outcomes were self-assessed before and after the intervention, and acceptance was assessed after the intervention. Engagement was measured during the intervention using self-reports and usage data. Results: A total of 198 participants (mean age 38.7, SD 12.14 y; n=172, 86.9% women) participated in the study (intervention group: n=110; waitlist control group: n=88). After the intervention, the intention-to-treat analysis revealed evidence for improved well-being (treatment: β estimate=–3.28, 95% CI –5.07 to –1.48) with moderate between-group effects (Cohen d=–0.66, 95% CI –0.99 to –0.33) in favor of the intervention group. We also found evidence of reduced somatic symptoms, perceived stress, and absenteeism and presenteeism, as well as improved headache management self-efficacy, application of behavior change techniques, and pain coping skills, with effects ranging from medium to large (Cohen d=0.43-1.05). Overall, 64.8% (118/182) of the participants used coaching as intended by engaging throughout the coaching and completing the outro. Conclusions: BalanceUP was well accepted, and the results suggest that coaching delivered by a CA can be effective in reducing the burden of people who experience headaches by improving their well-being. Trial Registration: German Clinical Trials Register DRKS00017422; https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00017422 %M 38265863 %R 10.2196/50132 %U https://www.jmir.org/2024/1/e50132 %U https://doi.org/10.2196/50132 %U http://www.ncbi.nlm.nih.gov/pubmed/38265863 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e49590 %T Comparing the Efficacy of Targeted and Blast Portal Messaging in Message Opening Rate and Anticoagulation Initiation in Patients With Atrial Fibrillation in the Preventing Preventable Strokes Study II: Prospective Cohort Study %A Kapoor,Alok %A Patel,Parth %A Chennupati,Soumya %A Mbusa,Daniel %A Sadiq,Hammad %A Rampam,Sanjeev %A Leung,Robert %A Miller,Megan %A Vargas,Kevin Rivera %A Fry,Patrick %A Lowe,Mary Martin %A Catalano,Christina %A Harrison,Charles %A Catanzaro,John Nicholas %A Crawford,Sybil %A Smith,Anne Marie %+ University of Massachusetts Chan Medical School, 55 N Lake Ave, Worcester, MA, 01655, United States, 1 9178564538, alok.kapoor@umassmemorial.org %K anticoagulants %K atrial fibrillation %K humans %K outpatients %K patient education as topic %K patient portals %D 2024 %7 24.1.2024 %9 Original Paper %J JMIR Cardio %G English %X Background: The gap in anticoagulation use among patients with atrial fibrillation (AF) is a major public health threat. Inadequate patient education contributes to this gap. Patient portal–based messaging linked to educational materials may help bridge this gap, but the most effective messaging approach is unknown. Objective: This study aims to compare the responsiveness of patients with AF to an AF or anticoagulation educational message between 2 portal messaging approaches: sending messages targeted at patients with upcoming outpatient appointments 1 week before their scheduled appointment (targeted) versus sending messages to all eligible patients in 1 blast, regardless of appointment scheduling status (blast), at 2 different health systems: the University of Massachusetts Chan Medical School (UMass) and the University of Florida College of Medicine-Jacksonville (UFL). Methods: Using the 2 approaches, we sent patient portal messages to patients with AF and grouped patients by high-risk patients on anticoagulation (group 1), high-risk patients off anticoagulation (group 2), and low-risk patients who may become eligible for anticoagulation in the future (group 3). Risk was classified based on the congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke, vascular disease, age between 65 and 74 years, and sex category (CHA2DS2-VASc) score. The messages contained a link to the Upbeat website of the Heart Rhythm Society, which displays print and video materials about AF and anticoagulation. We then tracked message opening, review of the website, anticoagulation use, and administered patient surveys across messaging approaches and sites using Epic Systems (Epic Systems Corporation) electronic health record data and Google website traffic analytics. We then conducted chi-square tests to compare potential differences in the proportion of patients opening messages and other evaluation metrics, adjusting for potential confounders. All statistical analyses were performed in SAS (version 9.4; SAS Institute). Results: We sent 1686 targeted messages and 1450 blast messages. Message opening was significantly higher with the targeted approach for patients on anticoagulation (723/1156, 62.5% vs 382/668, 57.2%; P=.005) and trended the same in patients off anticoagulation; subsequent website reviews did not differ by messaging approach. More patients off anticoagulation at baseline started anticoagulation with the targeted approach than the blast approach (adjusted percentage 9.3% vs 2.1%; P<.001). Conclusions: Patients were more responsive in terms of message opening and subsequent anticoagulation initiation with the targeted approach. %M 38265849 %R 10.2196/49590 %U https://cardio.jmir.org/2024/1/e49590 %U https://doi.org/10.2196/49590 %U http://www.ncbi.nlm.nih.gov/pubmed/38265849 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 9 %N %P e52987 %T The Potential of a Digital Weight Management Program to Support Specialist Weight Management Services in the UK National Health Service: Retrospective Analysis %A Richards,Rebecca %A Wren,Gina %A Whitman,Michael %+ Second Nature, 483 Green Lanes, London, N13 4BS, United Kingdom, 44 020 3488 0769, becky@secondnature.io %K digital health intervention %K smartphone %K diabetes management %K obesity management %K mobile phone %K management %K obesity %K digital health %K diabetes %K weight %K manage %K support %K weight management %K retrospective analysis %K treatment %K type 2 diabetes %K effectiveness %K primary care %K weight loss %K clinical %K primary care service %D 2024 %7 24.1.2024 %9 Original Paper %J JMIR Diabetes %G English %X Background: Digital weight management interventions (DWMIs) have the potential to support existing specialist weight management services (SWMS) in the National Health Service (NHS) to increase access to treatment for people living with obesity and type 2 diabetes. At present, there is limited real-world evidence and long-term outcomes on the potential effectiveness of DWMIs to support such services. Objective: This study aimed to examine real-world data to evaluate the impact of Second Nature’s 12-month DWMI for patients living with obesity with or without type 2 diabetes, referred from NHS primary care services, on sustained weight loss over a 2-year period. Methods: Retrospective data were extracted in August 2023 for participants who participated in the program between January 1, 2017, and January 8, 2021. Eligible participants were adults with a BMI ≥35 kg/m2, with or without type 2 diabetes. The primary outcomes were weight change in kilograms and percentage weight change at 2 years. Secondary outcomes were weight loss at 1 year, program engagement, and the proportion of participants who achieved ≥5% and ≥10% weight loss. Differences in weight loss between baseline and the 1- and 2-year follow-up points were compared using paired 2-tailed t tests. Linear regression models were used to examine whether participants’ ethnicity, indices of multiple deprivation, presence of type 2 diabetes, or program engagement were associated with weight loss at 1 year or 2 years. Results: A total of 1130 participants with a mean baseline BMI of 46.3 (SD 31.6) kg/m2 were included in the analysis. Of these participants, 65% (740/1130) were female (mean age 49.9, SD 12.0 years), 18.1% (205/339) were from Black, Asian, mixed, or other ethnicities, and 78.2% (884/1130) had type 2 diabetes. A total of 281 (24.9%) participants recorded weight readings at 2 years from baseline, with a mean weight loss of 13.8 kg (SD 14.2 kg; P<.001) or 11.8% (SD 10.9%; P<.001). A total of 204 (18.1%) participants achieved ≥5% weight loss, and 130 (11.5%) participants reached ≥10% weight loss. Weight loss did not significantly differ by ethnicity, indices of multiple deprivation, presence of type 2 diabetes, or engagement in the program. Conclusions: The findings suggested that Second Nature’s DWMI has the potential to support people living with obesity and type 2 diabetes remotely to achieve clinically significant and sustained weight loss at 2 years from baseline. Further research is needed to compare the intervention to standard care and assess integration with multidisciplinary clinical teams and pharmacotherapy in order to support this study’s findings. %M 38265852 %R 10.2196/52987 %U https://diabetes.jmir.org/2024/1/e52987 %U https://doi.org/10.2196/52987 %U http://www.ncbi.nlm.nih.gov/pubmed/38265852 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e46941 %T Culturally Adapting the World Health Organization Digital Intervention for Family Caregivers of People With Dementia (iSupport): Community-Based Participatory Approach %A Messina,Anna %A Amati,Rebecca %A Annoni,Anna Maria %A Bano,Beatrice %A Albanese,Emiliano %A Fiordelli,Maddalena %+ Institute of Public Health, Faculty of Biomedical Sciences, Università della Svizzera italiana, Via Buffi 13, Lugano, 6900, Switzerland, 41 0782104055, anna.messina@usi.ch %K informal caregivers %K iSupport %K dementia %K digital interventions %K mHealth %K community-based participatory research %K community %K caregiver %K mental distress %K physical distress %K support %K development %D 2024 %7 24.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Informal caregivers of people with dementia are at high risk of developing mental and physical distress because of the intensity of the care provided. iSupport is an evidence-based digital program developed by the World Health Organization to provide education and support for the informal everyday care of people living with dementia. Objective: Our study aims to describe in detail the cultural adaptation process of iSupport in Switzerland. We specifically focused on the participatory strategies we used to design a culturally adapted, Swiss version of iSupport that informed the development of the desktop version, mobile app, and printed manual. Methods: We used a mixed methods design, with a community-based participatory approach. The adaptation of iSupport followed the World Health Organization adaptation guidelines and was developed in 4 phases: content translation, linguistic and cultural revision by the members of the community advisory board, validation with formal and informal caregivers, and refinement and final adaptation. Results: The findings from each phase showed and consolidated the adjustments needed for a culturally adapted, Swiss version of iSupport. We collected feedback and implemented changes related to the following areas: language register and expressions (eg, from “lesson” to “chapter” and from “suffering from” dementia to “affected by” dementia), resources (hyperlinks to local resources for dementia), contents (eg, from general nonfamiliar scenarios to local and verisimilar examples), graphics (eg, from generalized illustrations of objects to human illustrations), and extra features (eg, a glossary, a forum session, and a read-aloud option, as well as a navigation survey). Conclusions: Our study provides evidence on how to culturally adapt a digital program for informal caregivers of people living with dementia. Our results suggest that adopting a community-based participatory approach and collecting lived experiences from the final users and stakeholders is crucial to meet local needs and to inform the further development, testing, and implementation of digital interventions in a specific cultural context. %M 38265857 %R 10.2196/46941 %U https://formative.jmir.org/2024/1/e46941 %U https://doi.org/10.2196/46941 %U http://www.ncbi.nlm.nih.gov/pubmed/38265857 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53130 %T Participatory Development and Assessment of Audio-Delivered Interventions and Written Material and Their Impact on the Perception, Knowledge, and Attitudes Toward Leprosy in Nigeria: Protocol for a Cluster Randomized Controlled Trial %A Murphy-Okpala,Ngozi %A Dahiru,Tahir %A van ’t Noordende,Anna T %A Gunesch,Carolin %A Chukwu,Joseph %A Nwafor,Charles %A Abdullahi,Suleiman Hudu %A Anyaike,Chukwuma %A Okereke,Ugochinyere Angelic %A Meka,Anthony %A Eze,Chinwe %A Ezeakile,Okechukwu %A Ekeke,Ngozi %+ RedAid Nigeria, 56 Nza Street, Independence Layout, Enugu, 23401, Nigeria, 234 706 749 0052, ngozi.murphyokpala@redaid-nigeria.org %K audio health education %K community perception of leprosy %K health education %K leprosy %K Nigeria %K persons affected by leprosy %D 2024 %7 24.1.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: In Nigeria, similar to many leprosy-endemic countries, leprosy is highly stigmatized. High levels of stigma among community members as well as internalized stigma among persons affected by leprosy often result in negative psychosocial consequences for those affected. To break this vicious cycle, it is important to conduct context-specific behavioral change activities. Although written material has been successful in improving knowledge and perception, it is not suitable for populations with low educational levels. Audio-delivered interventions are likely to be more suitable for people who are illiterate. This study proposes to assess the impact of an audio-delivered intervention on the perception (knowledge, attitudes, and beliefs) of community members with regard to leprosy in Nigeria. Objective: This study aims to assess the impact of audio-delivered and written health education on the perception of leprosy. Specific objectives are to (1) investigate the perception (local beliefs, knowledge, and attitudes) of community members toward leprosy and persons affected by leprosy; (2) investigate whether there is a difference in impact on perception between participants who have received audio-delivered health education and those who have received written health education, with specific reference to gender differences and differences between rural and urban areas; and (3) assess the impact of the participatory development of the audio-delivered and written interventions on empowerment and internalized stigma of persons affected by leprosy who developed the interventions. Additionally, we will translate and cross-culturally validate 4 study instruments measuring outcomes in 2 major Nigerian languages. Methods: We will use a mixed methods, cross-sectional study design for the intervention development and a 3-arm cluster randomized controlled trial for its implementation and evaluation, comprising (1) baseline assessments of knowledge, attitudes, perceptions, and fears of community members, to develop the audio-delivered content and written material, and the self-esteem and internalized stigma of persons affected by leprosy; and (2) participatory development of the audio-delivered content and written material by persons affected by leprosy and the pilot and implementation of the interventions. This will be done among different groups (selected using cluster randomization) that will be compared (control group, audio-intervention group, and written material group) to evaluate the intervention and the impact of developing the intervention on the persons affected. Results: This study was funded in June 2022, and community member participant recruitment started in January 2023. Baseline data collection was completed by May 2023 (n=811). Participatory cocreation of the audio and written health education content began in July 2023, and the materials are currently under development. Study results are expected in September 2024. Conclusions: Study findings will contribute to developing evidence-based, context-specific behavioral change interventions, which are critical to addressing stigma in many leprosy-endemic communities where leprosy is highly stigmatized, and contribute toward global triple zero leprosy efforts. Trial Registration: Pan African Clinical Trial Registry PACTR202205543939385; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=23667 International Registered Report Identifier (IRRID): DERR1-10.2196/53130 %M 38265859 %R 10.2196/53130 %U https://www.researchprotocols.org/2024/1/e53130 %U https://doi.org/10.2196/53130 %U http://www.ncbi.nlm.nih.gov/pubmed/38265859 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e38064 %T Experiences Among Patients With Cystic Fibrosis in the MucoExocet Study of Using Connected Devices for the Management of Pulmonary Exacerbations: Grounded Theory Qualitative Research %A Morsa,Maxime %A Perrin,Amélie %A David,Valérie %A Rault,Gilles %A Le Roux,Enora %A Alberti,Corinne %A Gagnayre,Rémi %A Pougheon Bertrand,Dominique %+ Adaptation, Resilience and Change Research Unit, University of Liège, 1 Place des Orateurs, Liège, 4000, Belgium, 32 4 3662272, maxime.morsa@uliege.be %K cystic fibrosis %K mobile health %K mHealth %K patient education %K chronic disease %K empowerment %K devices %K patients %K detection %K treatment %K respiratory %K education %K monitoring %K care %D 2024 %7 23.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Early detection of pulmonary exacerbations (PEx) in patients with cystic fibrosis is important to quickly trigger treatment and reduce respiratory damage. An intervention was designed in the frame of the MucoExocet research study providing patients with cystic fibrosis with connected devices and educating them to detect and react to their early signs of PEx. Objective: This study aims to identify the contributions and conditions of home monitoring in relation to their care teams from the users’ point of view to detect PEx early and treat it. This study focused on the patients’ experiences as the first and main users of home monitoring. Methods: A qualitative study was conducted to explore patients’ and professionals’ experiences with the intervention. We interviewed patients who completed the 2-year study using semistructured guides and conducted focus groups with the care teams. All the interviews were recorded and transcribed verbatim. Their educational material was collected. A grounded analysis was conducted by 2 researchers. Results: A total of 20 patients completed the study. Three main categories emerged from the patients’ verbatim transcripts and were also found in those of the professionals: (1) task technology fit, reflecting reliability, ease of use, accuracy of data, and support of the technology; (2) patient empowerment through technology, grouping patients’ learnings, validation of their perception of exacerbation, assessment of treatment efficacy, awareness of healthy behaviors, and ability to react to PEx signs in relation to their care team; (3) use, reflecting a continuous or intermittent use, the perceived usefulness balanced with cumbersome measurements, routinization and personalization of the measurement process, and the way data are shared with the care team. Furthermore, 3 relationships were highlighted between the categories that reflect the necessary conditions for patient empowerment through the use of technology. Conclusions: We discuss a theorization of the process of patient empowerment through the use of connected devices and call for further research to verify or amend it in the context of other technologies, illnesses, and care organizations. Trial Registration: ClinicalTrials.gov NCT03304028; https://clinicaltrials.gov/ct2/show/results/NCT03304028 %M 38261372 %R 10.2196/38064 %U https://formative.jmir.org/2024/1/e38064 %U https://doi.org/10.2196/38064 %U http://www.ncbi.nlm.nih.gov/pubmed/38261372 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e49467 %T Design and Implementation of a Brief Digital Mindfulness and Compassion Training App for Health Care Professionals: Cluster Randomized Controlled Trial %A Jaiswal,Satish %A Purpura,Suzanna R %A Manchanda,James K %A Nan,Jason %A Azeez,Nihal %A Ramanathan,Dhakshin %A Mishra,Jyoti %+ Department of Psychiatry, University of California San Diego, 9452 Medical Center Dr, La Jolla, CA, San Diego, CA, 92037, United States, 1 858 232 2855, s2jaiswal@health.ucsd.edu %K compassion %K digital app %K digital health %K digital intervention %K digital mental health %K digital mindfulness %K EEG %K health workers %K healthcare professionals %K mindfulness %K neuroplasticity %K physicians %K training %D 2024 %7 22.1.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: Several studies show that intense work schedules make health care professionals particularly vulnerable to emotional exhaustion and burnout. Objective: In this scenario, promoting self-compassion and mindfulness may be beneficial for well-being. Notably, scalable, digital app–based methods may have the potential to enhance self-compassion and mindfulness in health care professionals. Methods: In this study, we designed and implemented a scalable, digital app–based, brief mindfulness and compassion training program called “WellMind” for health care professionals. A total of 22 adult participants completed up to 60 sessions of WellMind training, 5-10 minutes in duration each, over 3 months. Participants completed behavioral assessments measuring self-compassion and mindfulness at baseline (preintervention), 3 months (postintervention), and 6 months (follow-up). In order to control for practice effects on the repeat assessments and calculate effect sizes, we also studied a no-contact control group of 21 health care professionals who only completed the repeated assessments but were not provided any training. Additionally, we evaluated pre- and postintervention neural activity in core brain networks using electroencephalography source imaging as an objective neurophysiological training outcome. Results: Findings showed a post- versus preintervention increase in self-compassion (Cohen d=0.57; P=.007) and state-mindfulness (d=0.52; P=.02) only in the WellMind training group, with improvements in self-compassion sustained at follow-up (d=0.8; P=.01). Additionally, WellMind training durations correlated with the magnitude of improvement in self-compassion across human participants (ρ=0.52; P=.01). Training-related neurophysiological results revealed plasticity specific to the default mode network (DMN) that is implicated in mind-wandering and rumination, with DMN network suppression selectively observed at the postintervention time point in the WellMind group (d=–0.87; P=.03). We also found that improvement in self-compassion was directly related to the extent of DMN suppression (ρ=–0.368; P=.04). Conclusions: Overall, promising behavioral and neurophysiological findings from this first study demonstrate the benefits of brief digital mindfulness and compassion training for health care professionals and compel the scale-up of the digital intervention. Trial Registration: Trial Registration: International Standard Randomized Controlled Trial Number Registry ISRCTN94766568, https://www.isrctn.com/ISRCTN94766568 %M 38252479 %R 10.2196/49467 %U https://mental.jmir.org/2024/1/e49467 %U https://doi.org/10.2196/49467 %U http://www.ncbi.nlm.nih.gov/pubmed/38252479 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 9 %N %P e48019 %T Effects of Digitization of Self-Monitoring of Blood Glucose Records Using a Mobile App and the Cloud System on Outpatient Management of Diabetes: Single-Armed Prospective Study %A Handa,Tomoko %A Onoue,Takeshi %A Kobayashi,Tomoko %A Maeda,Ryutaro %A Mizutani,Keigo %A Yamagami,Ayana %A Kinoshita,Tamaki %A Yasuda,Yoshinori %A Iwama,Shintaro %A Miyata,Takashi %A Sugiyama,Mariko %A Takagi,Hiroshi %A Hagiwara,Daisuke %A Suga,Hidetaka %A Banno,Ryoichi %A Azuma,Yoshinori %A Kasai,Takatoshi %A Yoshioka,Shuko %A Kuwatsuka,Yachiyo %A Arima,Hiroshi %+ Department of Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan, 81 52 744 2142, t-onoue@med.nagoya-u.ac.jp %K app %K diabetes care %K diabetes %K digital intervention %K digital therapeutics %K glycemic control %K mobile app %K mHealth %D 2024 %7 19.1.2024 %9 Original Paper %J JMIR Diabetes %G English %X Background: In recent years, technologies promoting the digitization of self-monitoring of blood glucose (SMBG) records including app-cloud cooperation systems have emerged. Studies combining these technological interventions with support from remote health care professionals have reported improvements in glycemic control. Objective: To assess the use of an app-cloud cooperation system linked with SMBG devices in clinical settings, we evaluated its effects on outpatient management of diabetes without remote health care professional support. Methods: In this multicenter, open-label, and single-armed prospective study, 48 patients with diabetes (including type 1 and type 2) at 3 hospitals in Japan treated with insulin or glucagon-like peptide 1 receptor agonists and performing SMBG used the app-cloud cooperation system for 24 weeks. The SMBG data were automatically uploaded to the cloud via the app. The patients could check their data, and their attending physicians reviewed the data through the cloud prior to the patients’ regular visits. The primary outcome was changes in glycated hemoglobin (HbA1c) levels. Results: Although HbA1c levels did not significantly change in all patients, the frequency of daily SMBG following applying the system was significantly increased before induction at 12 (0.60 per day, 95% CI 0.19-1.00; P=.002) and 24 weeks (0.43 per day, 95% CI 0.02-0.84; P=.04). In the subset of 21 patients whose antidiabetic medication had not been adjusted during the intervention period, a decrease in HbA1c level was observed at 12 weeks (P=.02); however, this significant change disappeared at 24 weeks (P=.49). The Diabetes Treatment Satisfaction Questionnaire total score and “Q4: convenience” and “Q5: flexibility” scores significantly improved after using the system (all P<.05), and 72% (33/46) patients and 76% (35/46) physicians reported that the app-cloud cooperation system helped them adjust insulin doses. Conclusions: The digitization of SMBG records and sharing of the data by patients and attending physicians during face-to-face visits improved self-management in patients with diabetes. Trial Registration: Japan Registry of Clinical Trials (jRCT) jRCTs042190057; https://jrct.niph.go.jp/en-latest-detail/jRCTs042190057 %M 38241065 %R 10.2196/48019 %U https://diabetes.jmir.org/2024/1/e48019 %U https://doi.org/10.2196/48019 %U http://www.ncbi.nlm.nih.gov/pubmed/38241065 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 13 %N %P e48587 %T Strategies to Alleviate the Burden Experienced by Informal Caregivers of Persons With Severe Mental Disorders in Low- and Middle-Income Countries: Scoping Review %A Silaule,Olindah %A Casteleijn,Daleen %A Adams,Fasloen %A Nkosi,Nokuthula Gloria %+ Department of Occupational Therapy, University of the Witwatersrand, 7 York Road, Parktown, Johannesburg, 2193, South Africa, 27 0782035213, osilaule@cartafrica.org %K severe mental disorders %K informal caregivers %K caregiver stress %K caregiver support %K low- and middle-income country %K mobile phone %D 2024 %7 18.1.2024 %9 Review %J Interact J Med Res %G English %X Background: There is considerable evidence of the burden of care encountered by informal caregivers of persons with severe and enduring mental health conditions in low- and middle-income countries. Previous studies have highlighted the need to support these informal caregivers as key players in the care of these patients. To date, limited evidence exists on the extent and types of strategies for supporting these informal caregivers in low- and middle-income countries. Objective: This scoping review aims to identify and describe the extent and type of evidence on the existing strategies for alleviating the burden of care among informal caregivers of persons with severe and enduring mental health conditions in low- and middle-income countries. Methods: A systematic literature search was completed following the Joanna Briggs Institute methodology for scoping reviews. The participants, concept, and context framework was used to guide the search for literature sources across 5 databases: PubMed, MEDLINE, CINAHL, and PsycINFO for published literature and ProQuest for unpublished literature. This review included studies that reported on strategies for alleviating the burden of care among informal caregivers of persons with severe and enduring mental health conditions, with a focus on studies that evaluated or recommended caregiver interventions and support strategies in low- and middle-income countries. The search was limited to studies conducted between 2001 and 2021, and only papers written in English were considered for inclusion. Using the Covidence software (Veritas Health Innovation), 2 reviewers independently screened the papers, applied the inclusion and exclusion criteria, and met biweekly to discuss and resolve conflicts. The relevant studies and reported outcomes were summarized, organized, and analyzed descriptively using numeric summary analysis and deductive content analysis. Results: Of the 18,342 studies identified, 44 (0.24%) met the inclusion criteria. The included studies were from 16 low- and middle-income countries in Asia, Africa, Europe, and South and North America. Most studies (21/44, 48%) were randomized controlled trials conducted in Asian countries. The identified strategies were grouped into 2 categories: implemented and recommended intervention strategies. Identified strategies included community-based interventions, psychoeducation interventions, support groups, cognitive behavioral therapy, spirituality-based interventions, and smartphone-based interventions. In addition, mindfulness and empowerment, collaborative interventions, standard care, financial and social support, counseling, occupation-based interventions, policy and legislature, and access to mental health care were identified. Psychoeducation and support group interventions were identified as common strategies for alleviating the burden of care among informal caregivers of persons with severe and enduring mental health conditions. Conclusions: This review provides evidence on the types of implemented and recommended strategies for alleviating the burden of care among informal caregivers in low- and middle-income countries. Although psychoeducational interventions were the most preferred strategy for alleviating burden, their benefits were short-lived when compared with peer-led support groups. International Registered Report Identifier (IRRID): RR2-10.2196/44268 %M 38236636 %R 10.2196/48587 %U https://www.i-jmr.org/2024/1/e48587 %U https://doi.org/10.2196/48587 %U http://www.ncbi.nlm.nih.gov/pubmed/38236636 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e52835 %T Development and Usability Testing of an mHealth Tool for Trauma-Informed Prevention of Substance Use, HIV Acquisition, and Risky Sexual Behaviors Among Adolescents: Mixed Methods Study %A Danielson,Carla Kmett %A Moreland,Angela %A Hahn,Austin %A Banks,Devin %A Ruggiero,Kenneth J %+ Department of Psychiatry & Behavioral Science, Medical University of South Carolina, 67 President Street, Charleston, SC, 29425, United States, 1 8437922945, danielso@musc.edu %K traumatic stress %K prevention %K substance use %K HIV %K qualitative methods %K adolescents %K mobile phone %D 2024 %7 18.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Youth who experience traumatic events are at a substantially higher risk of engaging in substance use and sexual risk behaviors and problems (eg, HIV acquisition) than their non–trauma-exposed counterparts. Evidence-based substance use and risky sexual behavior prevention may reduce the risk of these outcomes. Trauma-focused mental health treatment provides a window of opportunity for the implementation of such preventive work with these youth. However, overburdened clinicians face challenges in adding prevention content while implementing evidence-based treatments. Mobile health (mHealth) tools can help reduce this burden in delivering prevention curricula. Trauma-Informed Prevention for Substance Use and Risky Sexual Behavior (TIPS) is an mHealth app that was developed to aid trauma-focused cognitive behavioral therapy (TF-CBT) clinicians in the implementation of an evidence-based risk behavior prevention curriculum. Objective: The goal of this paper is to describe the rationale for and development of the TIPS app and present the results of a mixed methods approach for the initial evaluation of its usability. Methods: Participants included clinicians (n=11), adolescents (n=11), and caregivers (n=10) who completed qualitative interviews and an adapted version of the Website Analysis and Measurement Inventory. Results: In total, 4 overarching themes emerged from the participants’ answers to the qualitative interview questions, demonstrating a generally positive response to the app. The themes were (1) strength of app content, (2) suggestions about app content, (3) esthetics and usability, and (4) benefits to the patient and session implementation. Clinicians, adolescents, and caregivers all agreed that the content was very relevant to adolescents and used examples and language that adolescents could relate to. All 3 groups also discussed that the content was comprehensive and addressed issues often faced by adolescents. All 3 groups of users made suggestions about the esthetics, which mostly comprised suggestions to change the font, color, or pictures within the app. Of all the groups, adolescents were most positive about the esthetics and usability of the app. Results from the Website Analysis and Measurement Inventory further illustrated the users’ favorable reaction to the TIPS app, with 100% (11/11) of clinicians, 100% (10/10) of caregivers, and most adolescents (7/11, 64%) selecting strongly agree or somewhat agree to the following statement: “This app has much that is of interest to me.” Adolescents generally found the app easier to use than did caregivers and clinicians. Conclusions: The TIPS app shows promise as an mHealth tool for TF-CBT clinicians to integrate evidence-based substance use, risky sexual behavior, and HIV prevention during treatment. Future research, including a randomized controlled trial comparing TF-CBT implementation with and without the inclusion of the app, is necessary to evaluate the feasibility and efficacy of the app in reducing the risk of substance use and risky sexual behavior among trauma-exposed adolescents. Trial Registration: ClinicalTrials.gov NCT03710720; https://clinicaltrials.gov/study/NCT03710720 %M 38236634 %R 10.2196/52835 %U https://formative.jmir.org/2024/1/e52835 %U https://doi.org/10.2196/52835 %U http://www.ncbi.nlm.nih.gov/pubmed/38236634 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e48945 %T Designing a Web-Based Navigation Tool to Support Access to Youth Mental Health Services: Qualitative Study %A Calear,Alison L %A Batterham,Philip J %A McCallum,Sonia M %A Banfield,Michelle %A Moore,Elizabeth %A Johnson,Natalie %A Morse,Alyssa R %+ Centre for Mental Health Research, The Australian National University, 63 Eggleston Road, Canberra, 2601, Australia, 61 261258406, Alison.Calear@anu.edu.au %K mental health services %K youth %K navigation tool %K mental health %K website %K user experience %K design %K service %K services %K access %K accessibility %K health care system %D 2024 %7 18.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Many young people with mental health problems do not readily seek help or receive treatment and support. One way to address low help-seeking behavior is to improve access to information on mental health services and how to navigate the mental health system via a web-based tool. Seeking input from the end users (young people and parents or caregivers) on key features of the tool is imperative to ensure that it is relevant, engaging, and likely to meet their needs and expectations. Objective: This study aims to investigate young person and parent or caregiver views on the design, content, functioning, and user experience of a web-based mental health navigation tool to support connection to mental health services for children and young people aged up to 25 years. Methods: A total of 4 online focus groups were conducted: 2 with young people aged 16 years and older (total n=15) and 2 with parents or caregivers (total n=13). Focus groups were structured around a series of guiding questions to explore participants’ views on content, features, user experience, and design of a mental health navigation website. Focus groups were audio recorded with detailed notes taken. In addition, 53 young people aged 16-25 years and 97 parents or caregivers completed an online survey, comprising closed- and open-ended questions; open-ended responses were included with the focus group data in the qualitative analysis. All qualitative data were analyzed using thematic analysis. Results: A total of 2 topic areas and 7 themes were developed. The first topic area covered the types of information needs of young people and parents. Identified themes concerned the scope of the navigation website, as well as the provision of up-to-date and practical information on how to navigate the whole help-seeking process. The second topic area covered website features that would be beneficial and included the consideration of the website design; search engines; supported navigation; and forums, reviews, and user accounts. Conclusions: This study provides important insights into the navigation needs of young people and parents or caregivers in seeking mental health services. Key findings identified through this research have directly informed the development of MindMap, a web-based youth navigation tool providing a searchable database of local services, including a clear description, their location, and potential wait times. The website can be navigated independently or with support. %M 38236625 %R 10.2196/48945 %U https://formative.jmir.org/2024/1/e48945 %U https://doi.org/10.2196/48945 %U http://www.ncbi.nlm.nih.gov/pubmed/38236625 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e52662 %T Testing an Evidence-Based Self-Help Program for Infertility-Related Distress: Protocol for a Randomized Controlled Trial %A Gordon,Jennifer L %A Poulter,Megan M L %A Balsom,Ashley A %A Campbell,Tavis S %+ Department of Psychology, University of Regina, 3737 Wascana Parkway, Regina, SK, S4S 0A2, Canada, 1 306 585 4389, jennifer.gordon@uregina.ca %K anxiety %K cognitive-behavior therapy %K depression %K infertility %K infertility-related distress %K mHealth %D 2024 %7 18.1.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Infertility—the inability to achieve pregnancy despite ≥12 months of focused attempts to conceive—is experienced by 1 in 6 couples. Women typically carry a disproportionate share of the psychological burden associated with infertility, experiencing poor quality of life, and 30%-40% experiencing depressive mood or anxiety. Unfortunately, currently available psychological interventions targeting infertility-related distress are associated with modest effects. Objective: Our team, in collaboration with patient advisors, has designed a self-help intervention for infertility-related distress involving 7 weekly 10-minute videos addressing the cognitive, behavioral, and interpersonal challenges associated with infertility, delivered through a mobile app. A feasibility study suggests that it is well accepted and highly effective in reducing symptoms of anxiety and depressed mood among distressed individuals dealing with infertility. This study represents the next step in this line of research: a fully powered randomized controlled trial comparing the intervention to a waitlist control group. Methods: We will recruit 170 individuals struggling to become pregnant in Canada or the United States to be randomized to our 7-week self-help program or a treatment-as-usual condition. The primary outcome will be fertility quality of life, while secondary outcomes will include depressive symptoms, anxious symptoms, and relationship quality, assessed before and after the program as well as biweekly for 16 weeks following completion of the program. Self-reported health care use and the presence of diagnosed mood and anxiety disorders, assessed through a structured psychiatric interview, will also be assessed immediately following the intervention and at the 16-week follow-up assessment. Treatment adherence and retention will also be recorded throughout the intervention. Multilevel modeling will compare the intervention arm to the treatment-as-usual condition in terms of all continuous outcomes across the 9 measurement points. Logistic regression will be used to assess the occurrence of mood and anxiety disorders in the 2 treatment arms at the posttreatment assessment as well as at the 16-week follow-up. Sensitivity analyses will examine potential treatment moderators: membership in the LGBTQIA+ (lesbian, gay, bisexual, transgender, queer, intersex, and asexual) communities, baseline fertility quality of life, cultural background, disability status, and pursuit of conception through medical intervention. Results: We expect our intervention to be more effective than treatment-as-usual in improving all mental health parameters assessed and decreasing health care use related to both mental and reproductive health. Effects are expected to be larger with decreasing baseline quality of life and equally effective regardless of membership in the LGBTQIA+ communities, cultural background, or disability status. Conclusions: If our intervention is successful, this would suggest that it should be scaled up and made publicly available. The availability of this program would fill an important gap in light of the high rates of psychopathology among those experiencing infertility and considering the current lack of effective psychotherapy approaches for infertility. Trial Registration: Clinicaltrials.gov NCT06006936; https://classic.clinicaltrials.gov/ct2/show/NCT06006936 International Registered Report Identifier (IRRID): PRR1-10.2196/52662 %M 38236638 %R 10.2196/52662 %U https://www.researchprotocols.org/2024/1/e52662 %U https://doi.org/10.2196/52662 %U http://www.ncbi.nlm.nih.gov/pubmed/38236638 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e50787 %T Effectiveness of Telecare Interventions on Depression Symptoms Among Older Adults: Systematic Review and Meta-Analysis %A Wu,Man %A Li,Chaoyang %A Hu,Ting %A Zhao,Xueyang %A Qiao,Guiyuan %A Gao,Xiaolian %A Zhu,Xinhong %A Yang,Fen %+ School of Nursing, Hubei University of Chinese Medicine, North District, No 16, Huangjiahu West Road, Hongshan District, Wuhan, 430065, China, 86 18062003261, fenyang@hbtcm.edu.cn %K telecare %K depression %K anxiety %K quality of life %K older adults %K meta-analysis %D 2024 %7 17.1.2024 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Depression is the most common psychiatric disorder among older adults. Despite the effectiveness of pharmacological and psychological therapies, many patients with late-life depression (LLD) are unable to access timely treatment. Telecare has been shown to be effective in addressing patients' psychosocial issues, while its effectiveness in serving patients with LLD remains unclear. Objective: This study aimed to evaluate the effectiveness of telecare in reducing depression and anxiety symptoms and improving quality of life (QoL) in patients with LLD. Methods: Databases including the Cochrane Library, Web of Science, PubMed, Embase, and EBSCO were searched for randomized controlled trials (RCTs) evaluating the effectiveness of telecare for LLD from database establishment to December 28, 2022. Results: A total of 12 RCTs involving 1663 participants were identified in this study. The meta-analysis showed that (1) telecare significantly reduced depressive symptoms in patients with LLD compared to those in usual care (UC; standardized mean difference [SMD]=–0.46, 95% CI –0.53 to –0.38; P<.001), with the best improvement observed within 3 months of intervention (SMD=–0.72, 95% CI –1.16 to –0.28; P<.001); (2) other scales appeared more effective than the Patient Health Questionnaire-9 for LLD in telecare interventions (SMD=–0.65, 95% CI –0.96 to –0.35; P<.001); (3) telecare was more effective than telephone-based interventions for remote monitoring of LLD (SMD=–1.13, 95% CI –1.51 to –0.76; P<.001); (4) the reduction of depressive symptoms was more pronounced in patients with LLD with chronic conditions (SMD=–0.67, 95% CI –0.89 to –0.44; P<.001); (5) telecare was more effective for LLD in Europe and the Americas than in other regions (SMD=–0.73, 95% CI –0.99 to –0.47; P<.001); (6) telecare significantly reduced anxiety symptoms in patients with LLD (SMD=–0.53, 95% CI –0.73 to –0.33; P=.02); and (7) there was no significant improvement in the psychological components of QoL in patients with LLD compared to those receiving UC (SMD=0.30, 95% CI 0.18-0.43; P=.80). Conclusions: Telecare is a promising modality of care for treatment, which can alleviate depression and anxiety symptoms in patients with LLD. Continued in-depth research into the effectiveness of telecare in treating depression could better identify where older patients would benefit from this intervention. %M 38231546 %R 10.2196/50787 %U https://mhealth.jmir.org/2024/1/e50787 %U https://doi.org/10.2196/50787 %U http://www.ncbi.nlm.nih.gov/pubmed/38231546 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e49373 %T Effects of mHealth-Based Lifestyle Interventions on Gestational Diabetes Mellitus in Pregnant Women With Overweight and Obesity: Systematic Review and Meta-Analysis %A He,Yirong %A Huang,Chuanya %A He,Qiuyang %A Liao,Shujuan %A Luo,Biru %+ Department of Nursing, West China Second University Hospital, Sichuan University, #No. 20, Section 3, People’s South Road, Chengdu, Sichuan, 610041, China, 86 88570307, luomr@scu.edu.cn %K mobile health %K mHealth %K lifestyle intervention %K gestational diabetes mellitus %K meta-analysis %K mobile phone %D 2024 %7 17.1.2024 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: The increasing incidence of gestational diabetes mellitus (GDM) is a global health problem that is more likely to occur in pregnant women with overweight or obesity. Adhering to a healthy lifestyle is associated with a reduced risk of GDM. With the development of IT, mobile health (mHealth) interventions have become widely available in health care. However, there are no definitive conclusions on the effectiveness of mHealth-based lifestyle interventions in preventing GDM. Objective: This study aims to evaluate the impact of mHealth-based lifestyle interventions on GDM and other pregnancy outcomes in pregnant women with overweight or obesity. Methods: A systematic literature search was conducted in 5 English databases (MEDLINE, Embase, Web of Science, CENTRAL, and CINAHL) and 4 Chinese databases (CBM, CNKI, Vip, and Wanfang) to identify randomized controlled trials (RCTs) on the effectiveness of mHealth-based interventions for GDM from inception to January 10, 2023. In total, 2 authors independently screened the studies and extracted the data. The quality of the included studies was examined using the Cochrane risk-of-bias tool. Data synthesis was conducted using Review Manager (version 5.4; The Cochrane Collaboration). Results: A total of 16 RCTs with 7351 participants were included in this study. The included studies were published between 2014 and 2021 and were conducted in China, the United States, Australia, New Zealand, the United Kingdom, Ireland, and Norway. The sample sizes of the studies ranged from 75 to 2202, and the duration of the mHealth-based lifestyle interventions ranged from 4 to 28 weeks. Compared with usual care, mHealth-based lifestyle interventions significantly reduced the incidence of GDM (odds ratio [OR] 0.74, 95% CI 0.56-0.96; P=.03; I2=65%), preterm birth (OR 0.65, 95% CI 0.48-0.87; P=.004; I2=25%), macrosomia (OR 0.59, 95% CI 0.40-0.87; P=.008; I2=59%), and gestational weight gain (mean difference=−1.12 kg, 95% CI −1.44 to −0.80; P<.001; I2=43%). The subgroup analysis showed that interventions delivered via apps (OR 0.55, 95% CI 0.37-0.83; P=.004; I2=44%), provided by obstetricians (OR 0.69, 95% CI 0.51-0.93; P=.02; I2=60%), and targeted at Asian populations (OR 0.44, 95% CI 0.34-0.58; P<.001; I2=0%) and that used the International Association of Diabetes and Pregnancy Study Groups diagnostic criteria (OR 0.58, 95% CI 0.39-0.86; P=.007; I2=69%) showed a statistically significant reduction in the risk of GDM. Conclusions: mHealth-based lifestyle interventions had a favorable impact on the prevention of GDM in pregnant women with overweight and obesity. Future studies need to further explore the potential of mHealth-based interventions for GDM through better design and more rigorous large-scale RCTs. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42021286995; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=286995 %M 38231555 %R 10.2196/49373 %U https://mhealth.jmir.org/2024/1/e49373 %U https://doi.org/10.2196/49373 %U http://www.ncbi.nlm.nih.gov/pubmed/38231555 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e52197 %T Predictors of Use and Drop Out From a Web-Based Cognitive Behavioral Therapy Program and Health Community for Depression and Anxiety in Primary Care Patients: Secondary Analysis of a Randomized Controlled Trial %A Rotondi,Armando J %A Belnap,Bea Herbeck %A Rothenberger,Scott %A Feldman,Robert %A Hanusa,Barbara %A Rollman,Bruce L %+ Mental Illness Research Education and Clinical Center, VA Pittsburgh Healthcare System, Veterans Administration, Research Office Building (151R-U), University Drive C, Pittsburgh, PA, 15240, United States, 1 412 360 2494, armandorotondi1@gmail.com %K e-mental health %K user engagement %K initiation %K discontinue %K depression %K anxiety %K cognitive behavioral therapy %K computerized CBT %K online health community %K collaborative care %K internet support group %D 2024 %7 17.1.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: A previously reported study examined the treatment of primary care patients with at least moderate severity depressive or anxiety symptoms via an evidence-based computerized cognitive behavioral therapy (CCBT) program (Beating the Blues) and an online health community (OHC) that included a moderated internet support group. The 2 treatment arms proved to be equally successful at 6-month follow-up. Objective: Although highly promising, e-mental health treatment programs have encountered high rates of noninitiation, poor adherence, and discontinuation. Identifying ways to counter these tendencies is critical for their success. To further explore these issues, this study identified the primary care patient characteristics that increased the chances patients would not initiate the use of an intervention, (ie, not try it even once), initiate use, and go on to discontinue or continue to use an intervention. Methods: The study had 3 arms: one received access to CCBT (n=301); another received CCBT plus OHC (n=302), which included a moderated internet support group; and the third received usual care (n=101). Participants in the 2 active intervention arms of the study were grouped together for analyses of CCBT use (n=603) because both arms had access to CCBT, and there were no differences in outcomes between the 2 arms. Analyses of OHC use were based on 302 participants who were randomized to that arm. Results: Several baseline patient characteristics were associated with failure to initiate the use of CCBT, including having worse physical health (measured by the Short Form Health Survey Physical Components Score, P=.01), more interference from pain (by the Patient-Reported Outcomes Measurement Information System Pain Interference score, P=.048), less formal education (P=.02), and being African American or another US minority group (P=.006). Characteristics associated with failure to initiate use of the OHC were better mental health (by the Short Form Health Survey Mental Components Score, P=.04), lower use of the internet (P=.005), and less formal education (P=.001). Those who initiated the use of the CCBT program but went on to complete less of the program had less formal education (P=.01) and lower severity of anxiety symptoms (P=.03). Conclusions: This study found that several patient characteristics predicted whether a patient was likely to not initiate use or discontinue the use of CCBT or OHC. These findings have clear implications for actionable areas that can be targeted during initial and ongoing engagement activities designed to increase patient buy-in, as well as increase subsequent use and the resulting success of eHealth programs. Trial Registration: ClinicalTrials.gov NCT01482806; https://clinicaltrials.gov/study/NCT01482806 %M 38231552 %R 10.2196/52197 %U https://mental.jmir.org/2024/1/e52197 %U https://doi.org/10.2196/52197 %U http://www.ncbi.nlm.nih.gov/pubmed/38231552 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e54138 %T Digital Storytelling Intervention for Enhancing the Social Participation of People With Mild Cognitive Impairment: Co-Design and Usability Study %A Zhu,Di %A Al Mahmud,Abdullah %A Liu,Wei %+ Centre for Design Innovation, Swinburne University of Technology, John St, Hawthorn, Melbourne, VIC 3122, Australia, 61 392143830, aalmahmud@swin.edu.au %K co-design %K digital storytelling %K people with mild cognitive impairment %K MCI %K technology-based intervention development %K dementia %K mobile phone %D 2024 %7 17.1.2024 %9 Original Paper %J JMIR Aging %G English %X Background: Community-based social participation has shown promise in delaying cognitive decline in older adults with mild cognitive impairment (MCI) who are at risk of developing dementia. Although group storytelling interventions have proven effective, the need for a skilled workforce to support people with MCI can limit broader community implementation. Technology-based interventions may offer a solution to this limitation by replicating the abilities of therapists. Objective: This study aims to co-design a digital storytelling intervention and evaluate its usability. Methods: This co-design process involved 3 stages, engaging people with MCI (n=12), their caregivers (n=4), and therapists (n=5) in Beijing, China. In the first stage, we used card sorting and voting methods to identify potential incentives for social participation and target the specific abilities that people with MCI wanted to enhance. In the second stage, we conducted brainstorming sessions with people with MCI and their caregivers to identify the potential features of a digital storytelling application named Huiyou (“meeting new friends” in Chinese). Finally, we assessed Huiyou’s usability with people with MCI and therapists, leading to iterative improvements based on the usability findings. Results: We uncovered a crucial link between boosting the self-confidence of people with MCI and their ability to address social participation challenges. Notably, we identified memory improvement and enhanced language expression as key factors for effective communication with grandchildren. Subsequently, participants suggested features and interfaces to address these challenges, leading to the development of Huiyou, a group-based digital storytelling application featuring functions such as generating story materials, conducting memory retrieval activities, and sharing stories. It received an “excellent” rating in the User Experience Questionnaire benchmark, displaying high levels of attractiveness, dependability, stimulation, and novelty. People with MCI achieved an average task completion rate of 87% (n=19; SD 0.13) of the 22 tasks. However, feedback from people with MCI and therapists highlighted usability issues in navigation, activity management, user interface, and feature optimization, indicating a need for improved accessibility and efficiency. Conclusions: The co-design approach contributed to developing the Huiyou prototype, supporting community-based social participation. User feedback highlighted the potential of Huiyou to enhance well-being and facilitate meaningful social interactions while maintaining crucial existing relationships. %M 38231541 %R 10.2196/54138 %U https://aging.jmir.org/2024/1/e54138 %U https://doi.org/10.2196/54138 %U http://www.ncbi.nlm.nih.gov/pubmed/38231541 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e44199 %T The Report of Access and Engagement With Digital Health Interventions Among Children and Young People: Systematic Review %A Whitehead,Lisa %A Robinson,Suzanne %A Arabiat,Diana %A Jenkins,Mark %A Morelius,Evalotte %+ School of Nursing and Midwifery, Edith Cowan University, 270 Joondalup Drive, Joondalup, 6027, Australia, 61 438145638, l.whitehead@ecu.edu.au %K access %K engagement %K digital health technology %K mobile phone %K children %D 2024 %7 17.1.2024 %9 Review %J JMIR Pediatr Parent %G English %X Background: Digital health interventions are increasingly used to deliver health-related interventions for children and young people to change health behaviors and improve health outcomes. Digital health interventions have the potential to enhance access to and engagement with children and young people; however, they may also increase the divide between those who can access technology and are supported to engage and those who are not. This review included studies that reported on the access to or engagement with digital health interventions among children and young people. Objective: This review aims to identify and report on access and engagement in studies involving digital health interventions among children and young people. Methods: A systematic review following the Joanna Briggs Institute methods for conducting systematic reviews was conducted. An electronic literature search was conducted for all studies published between January 1, 2010, and August 2022, across sources, including MEDLINE, CINAHL, and PsycINFO. Studies were included if they examined any aspect of access or engagement in relation to interventions among children and young people. The quality of the included papers was assessed, and data were extracted. Data were considered for meta-analysis, where possible. Results: A total of 3292 references were identified using search terms. Following the exclusion of duplicates and review by inclusion criteria, 40 studies were independently appraised for their methodological quality. A total of 16 studies were excluded owing to their low assessed quality and flawed critical elements in the study design. The studies focused on a variety of health conditions; type 1 diabetes, weight management and obesity, mental health issues, and sexual health were the predominant conditions. Most studies were conducted in developed countries, with most of them being conducted in the United States. Two studies reported data related to access and considered ethnicity and social determinants. No studies used strategies to enhance or increase access. All studies included in the review reported on at least 1 aspect of engagement. Engagement with interventions was measured in relation to frequency of engagement, with no reference to the concept of effective engagement. Conclusions: Most digital health interventions do not consider the factors that can affect access and engagement. Of those studies that measured either access or engagement or both, few sought to implement strategies to improve access or engagement to address potential disparities between groups. Although the literature to date provides some insight into access and engagement and how these are addressed in digital health interventions, there are major limitations in understanding how both can be enhanced to promote equity. Consideration of both access and engagement is vital to ensure that children and young people have the ability to participate in studies. Trial Registration: PROSPERO CRD42020170874; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=170874 %M 38231560 %R 10.2196/44199 %U https://pediatrics.jmir.org/2024/1/e44199 %U https://doi.org/10.2196/44199 %U http://www.ncbi.nlm.nih.gov/pubmed/38231560 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e53931 %T A Blended Intervention Targeting Emotion Dysregulation in Adults With Attention-Deficit/Hyperactivity Disorder: Development and Feasibility Study %A Nordby,Emilie S %A Guribye,Frode %A Schønning,Viktor %A Andersen,Sander Lindholm %A Kuntsi,Jonna %A Lundervold,Astri J %+ Division of Psychiatry, Haukeland University Hospital, Sandviksleitet 1, Bergen, 5036, Norway, 47 45440197, emilie.nordby@uib.no %K ADHD %K adult %K adults %K app %K applications %K apps %K attention deficit %K blended intervention %K blended %K develop %K development %K digital %K emotion regulation %K emotion %K emotional %K emotions %K feasibility %K group session %K group sessions %K hybrid %K hyperactivity %K inattention %K mental health %K neurodevelopmental %K psychotherapy %K satisfaction %K skill %K training %D 2024 %7 17.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Many adults with attention-deficit/hyperactivity disorder (ADHD) experience difficulties related to emotion regulation. Such difficulties are known to substantially impact quality of life and overall functioning. Yet, there is a lack of treatment interventions specifically designed to address these challenges. Objective: This study aimed to describe the development and assess the feasibility, along with the initial clinical outcomes, of a novel blended intervention for adults with ADHD. The blended intervention combines both face-to-face and digital components and is specifically designed to address emotion dysregulation in ADHD. Methods: This intervention was an 8-week blended intervention combining weekly face-to-face group sessions with a supplementary digital companion app. The intervention is based on elements from dialectic behavioral therapy skills training and positive psychology. To evaluate its feasibility, we performed a 10-week feasibility study with an uncontrolled pre-post study design, including 16 adults with ADHD and co-occurring emotion dysregulation. The feasibility measures encompassed adherence, satisfaction, and perceived credibility of the intervention. Clinical outcomes were evaluated by self-reported symptoms of emotion dysregulation, inattention, hyperactivity-impulsivity, executive function, depression, anxiety, and a measure of quality of life. Paired sample 2-tailed t tests were used to analyze clinical outcomes with a Bonferroni-corrected significance level. Results: Both treatment credibility and treatment satisfaction were rated favorably by the majority of the participants. In particular, the participants emphasized meeting others with ADHD as beneficial. In terms of adherence, 3 participants withdrew before initiating the intervention, while another 4 participants did not complete the intervention. On average, the participants who enrolled in the intervention attended 6.2 of the 8 group sessions and completed 6.7 of the 8 skills training modules in the companion app. In terms of clinical outcomes, there was a reduction in symptoms of emotion dysregulation from before to after the intervention (d=2.0). Significant improvements were also observed in measures of inattention (d=1.1) and hyperactivity-impulsivity (d=0.9). However, no significant improvements were found in the domains of depression, anxiety, quality of life, and executive functioning. Conclusions: The results are encouraging, both in terms of feasibility and the preliminary clinical results on emotion dysregulation. The blended format, combining digital and face-to-face elements, may also seem to offer some advantages: the group-based format was valued as it facilitated peer interaction, while a rather high completion of modules in the companion app highlights its potential to enhance skills training between the group sessions. Future randomized controlled trials are called for to further evaluate the clinical effectiveness of the intervention. Trial Registration: ClinicalTrials.gov NCT05644028; https://clinicaltrials.gov/study/NCT05644028 %M 38231536 %R 10.2196/53931 %U https://formative.jmir.org/2024/1/e53931 %U https://doi.org/10.2196/53931 %U http://www.ncbi.nlm.nih.gov/pubmed/38231536 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e50399 %T Feasibility, Acceptability, and Potential Efficacy of a Self-Guided Internet-Delivered Dialectical Behavior Therapy Intervention for Substance Use Disorders: Randomized Controlled Trial %A Daros,Alexander R %A Guimond,Timothy H %A Yager,Christina %A Palermo,Emma H %A Wilks,Chelsey R %A Quilty,Lena C %+ Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, 1025 Queen Street West, Toronto, ON, M6J1H1, Canada, 1 5192533000 ext 2236, daros.alexander@gmail.com %K depression %K anxiety %K emotion dysregulation %K digital interventions %K dialectical behavior therapy %K substance use disorder %K alcohol use disorder %K randomized controlled trial %K eHealth %K mobile phone %D 2024 %7 16.1.2024 %9 Original Paper %J JMIR Ment Health %G English %X Background: People with alcohol and substance use disorders (SUDs) often have underlying difficulties in regulating emotions. Although dialectical behavioral therapy is effective for SUDs, it is often difficult to access. Self-guided, internet-delivered dialectical behavioral therapy (iDBT) allows for expanded availability, but few studies have rigorously evaluated it in individuals with SUDs. Objective: This study examines the feasibility, acceptability, and potential efficacy of an iDBT intervention in treatment-seeking adults with SUDs. We hypothesized that iDBT would be feasible, credible, acceptable, and engaging to people with SUDs. We also hypothesized that the immediate versus delayed iDBT group would show comparatively greater improvements and that both groups would show significant improvements over time. Methods: A 12-week, single-blinded, parallel-arm, randomized controlled trial was implemented, with assessments at baseline and at 4 (acute), 8, and 12 weeks (follow-up). A total of 72 community adults aged 18 to 64 years were randomized. The immediate group (n=38) received access to iDBT at baseline, and the delayed group (n=34) received access after 4 weeks. The intervention (Pocket Skills 2.0) was a self-guided iDBT via a website, with immediate access to all content, additional text and email reminders, and additional support meetings as requested. Our primary outcome was substance dependence, with secondary outcomes pertaining to feasibility, clinical outcomes, functional disability, and emotion dysregulation, among other measures. All outcomes were assessed using self-report questionnaires. Results: iDBT was perceived as a credible and acceptable treatment. In terms of feasibility, 94% (68/72) of the participants started iDBT, 13% (9/68) were early dropouts, 35% (24/68) used it for the recommended 8 days in the first month, and 50% (34/68) were still active 4 weeks later. On average, the participants used iDBT for 2 hours and 24 minutes across 10 separate days. In the acute period, no greater benefit was found for the immediate group on substance dependence, although we did find lower depression (b=−2.46; P=.02) and anxiety (b=−2.22; P=.02). At follow-up, there were greater benefits in terms of reduced alcohol (b=−2.00; P=.02) and nonalcoholic substance (b=−3.74; P=.01) consumption in the immediate access group. Both groups demonstrated improvements in substance dependence in the acute (b=−1.73; P<.001) and follow-up period (b=−2.09; P<.001). At follow-up, both groups reported reduced depression, anxiety, suicidal behaviors, emotional dysregulation, and functional disability. Conclusions: iDBT is a feasible and acceptable intervention for patients with SUDs, although methods for improving engagement are warranted. Although results did not support efficacy for the primary outcome at 4 weeks, findings support reductions in substance dependence and other mental health concerns at 12 weeks. Notwithstanding the limitations of this study, the results suggest the potential value of iDBT in the treatment of SUDs and other mental health conditions. Trial Registration: ClinicalTrials.gov NCT05094440; https://clinicaltrials.gov/show/NCT05094440 %M 38227362 %R 10.2196/50399 %U https://mental.jmir.org/2024/1/e50399 %U https://doi.org/10.2196/50399 %U http://www.ncbi.nlm.nih.gov/pubmed/38227362 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e51732 %T Enabling Personalization for Digital Cognitive Stimulation to Support Communication With People With Dementia: Pilot Intervention Study as a Prelude to AI Development %A Hird,Nick %A Osaki,Tohmi %A Ghosh,Samik %A Palaniappan,Sucheendra K %A Maeda,Kiyoshi %+ Aikomi Ltd Co, Yokohama Blue Avenue 12th Floor, 4-4-2 Minatomirai, Yokohama, Kanagawa, 220-0012, Japan, 81 70 4538 2854, nick.hird@aikomi.co.jp %K dementia %K digital technology %K communication %K engagement %K cognitive stimulation %K artificial intelligence %K AI %D 2024 %7 16.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Maintaining good communication and engagement between people with dementia and their caregivers is a major challenge in dementia care. Cognitive stimulation is a psychosocial intervention that supports communication and engagement, and several digital applications for cognitive stimulation have been developed. Personalization is an important factor for obtaining sustainable benefits, but the time and effort required to personalize and optimize applications often makes them difficult for routine use by nonspecialist caregivers and families. Although artificial intelligence (AI) has great potential to support automation of the personalization process, its use is largely unexplored because of the lack of suitable data from which to develop and train machine learning models. Objective: This pilot study aims to evaluate a digital application called Aikomi in Japanese care homes for its potential to (1) create and deliver personalized cognitive stimulation programs to promote communication and engagement between people with dementia and usual care staff and (2) capture meaningful personalized data suitable for the development of AI systems. Methods: A modular technology platform was developed and used to create personalized programs for 15 people with dementia living in 4 residential care facilities in Japan with the cooperation of a family member or care staff. A single intervention with the program was conducted with the person with dementia together with a care staff member, and for some participants, smell stimulation was provided using selected smell sticks in conjunction with the digital program. All sessions were recorded using a video camera, and the combined personalized data obtained by the platform were analyzed. Results: Most people with dementia (10/15, 67%) showed high levels of engagement (>40 on Engagement of a Person with Dementia Scale), and there were no incidences of negative reactions toward the programs. Care staff reported that some participants showed extended concentration and spontaneous communication while using Aikomi, which was not their usual behavior. Smell stimulation promoted engagement for some participants even when they were unable to identify the smell. No changes in well-being were observed following the intervention according to the Mental Function Impairment Scale. The level of response to each type of content in the stimulation program varied greatly according to the person with dementia, and personalized data captured by the Aikomi platform enabled understanding of correlations between stimulation content and responses for each participant. Conclusions: This study suggests that the Aikomi digital application is acceptable for use by persons with dementia and care staff and may have the potential to promote communication and engagement. The platform captures personalized data, which can provide suitable input for machine learning. Further investigation of Aikomi will be conducted to develop AI systems and create personalized digital cognitive stimulation applications that can be easily used by nonspecialist caregivers. %M 38227357 %R 10.2196/51732 %U https://formative.jmir.org/2024/1/e51732 %U https://doi.org/10.2196/51732 %U http://www.ncbi.nlm.nih.gov/pubmed/38227357 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e46402 %T Acceptance of Medical Artificial Intelligence in Skin Cancer Screening: Choice-Based Conjoint Survey %A Jagemann,Inga %A Wensing,Ole %A Stegemann,Manuel %A Hirschfeld,Gerrit %+ School of Business, University of Applied Sciences and Arts Bielefeld, Interaktion 1, Bielefeld, 33619, Germany, 49 521106 ext 70508, inga.jagemann@hsbi.de %K artificial intelligence %K skin cancer screening %K choice experiment %K melanoma %K conjoint analysis, technology acceptance %K adoption %K technology use %K dermatology %K skin cancer %K oncology %K screening %K choice based %K trust %D 2024 %7 12.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: There is great interest in using artificial intelligence (AI) to screen for skin cancer. This is fueled by a rising incidence of skin cancer and an increasing scarcity of trained dermatologists. AI systems capable of identifying melanoma could save lives, enable immediate access to screenings, and reduce unnecessary care and health care costs. While such AI-based systems are useful from a public health perspective, past research has shown that individual patients are very hesitant about being examined by an AI system. Objective: The aim of this study was two-fold: (1) to determine the relative importance of the provider (in-person physician, physician via teledermatology, AI, personalized AI), costs of screening (free, 10€, 25€, 40€; 1€=US $1.09), and waiting time (immediate, 1 day, 1 week, 4 weeks) as attributes contributing to patients’ choices of a particular mode of skin cancer screening; and (2) to investigate whether sociodemographic characteristics, especially age, were systematically related to participants’ individual choices. Methods: A choice-based conjoint analysis was used to examine the acceptance of medical AI for a skin cancer screening from the patient’s perspective. Participants responded to 12 choice sets, each containing three screening variants, where each variant was described through the attributes of provider, costs, and waiting time. Furthermore, the impacts of sociodemographic characteristics (age, gender, income, job status, and educational background) on the choices were assessed. Results: Among the 383 clicks on the survey link, a total of 126 (32.9%) respondents completed the online survey. The conjoint analysis showed that the three attributes had more or less equal importance in contributing to the participants’ choices, with provider being the most important attribute. Inspecting the individual part-worths of conjoint attributes showed that treatment by a physician was the most preferred modality, followed by electronic consultation with a physician and personalized AI; the lowest scores were found for the three AI levels. Concerning the relationship between sociodemographic characteristics and relative importance, only age showed a significant positive association to the importance of the attribute provider (r=0.21, P=.02), in which younger participants put less importance on the provider than older participants. All other correlations were not significant. Conclusions: This study adds to the growing body of research using choice-based experiments to investigate the acceptance of AI in health contexts. Future studies are needed to explore the reasons why AI is accepted or rejected and whether sociodemographic characteristics are associated with this decision. %M 38214959 %R 10.2196/46402 %U https://formative.jmir.org/2024/1/e46402 %U https://doi.org/10.2196/46402 %U http://www.ncbi.nlm.nih.gov/pubmed/38214959 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e52517 %T Mapping Respiratory Health Digital Interventions in South and Southeast Asia: Protocol for a Scoping Review %A Evans,Laura %A Evans,Jay %A Fletcher,Monica %A Abdullah,Adina %A Ahmed,Zakiuddin %+ Usher Institute, University of Edinburgh, Medical School, Teviot Place, Edinburgh, EH8 9AG, United Kingdom, 44 (0)131 651 4138, v1levan6@exseed.ed.ac.uk %K digital health %K respiratory health %K Asia %K scoping review %K landscape mapping %K digital health intervention %K digital health environment %K mobile health %K mHealth %D 2024 %7 12.1.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The last 2 decades have been a time of exponential growth and maturation for digital health, while the global burden of respiratory disease continues to grow worldwide. Leveraging digital health interventions (DHIs) to manage and mitigate respiratory disease and its adverse health effects presents itself as an obvious path forward. Objective: We aimed to understand the current digital landscape and enabling environment around respiratory health to reduce costs, avoid duplication, and understand the comprehensiveness of DHIs. Methods: This study will follow a scoping review methodology as outlined by Arksey and O’Malley, the Joanna Briggs Institute, and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. MEDLINE, Embase, CINAHL, PsycINFO, Cochrane Library, Web of Science, PakiMedNet, and MyMedR databases will be searched along with key websites, repositories, and gray literature databases. The terms “respiratory health,” “digital health,” “South Asia,” and “Southeast Asia,” as well as related terms will be searched. The results will be screened for duplicates and then against the inclusion and exclusion criteria. For the studies included, data will be extracted, collated, and analyzed. Results: The scoping review was started in July 2023 and will be finalized by February 2024. Results will be presented following the World Health Organization’s classification of DHIs to categorize interventions in a standardized format and the mobile health evidence reporting and assessment checklist to report on the effectiveness of interventions. Further exposition of the evidence extracted will be presented through narrative synthesis. Conclusions: As DHIs continue to proliferate, the need to understand the current landscape becomes more pertinent. In this scoping review, we will seek to more clearly understand what digital health tools and technologies are being used in the current landscape of digital health in South and Southeast Asia for respiratory health and to what extent they are addressing the respiratory health needs of the region. The results will inform recommendations on digital health tools for respiratory health in South and Southeast Asia will help funders and implementers of DHIs leverage existing technologies and accelerate innovations that address documented gaps in the studied countries. International Registered Report Identifier (IRRID): DERR1-10.2196/52517 %M 38214954 %R 10.2196/52517 %U https://www.researchprotocols.org/2024/1/e52517 %U https://doi.org/10.2196/52517 %U http://www.ncbi.nlm.nih.gov/pubmed/38214954 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e45854 %T A Behaviorally Informed Mobile App to Improve the Nutritional Quality of Grocery Shopping (SwapSHOP): Feasibility Randomized Controlled Trial %A Piernas,Carmen %A Lee,Charlotte %A Hobson,Alice %A Harmer,Georgina %A Payne Riches,Sarah %A Noreik,Michaela %A Jebb,Susan A %+ Nuffield Department of Primary Care Health Sciences, University of Oxford, 200 Woodstock Rd, Oxford, OX26GG, United Kingdom, 44 07752599266, carmen.piernas-sanchez@phc.ox.ac.uk %K swaps %K mobile app %K supermarket %K food purchases %K diet %K randomized controlled trial %K mobile phone %D 2024 %7 11.1.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Interventions targeting the nutritional quality of grocery shopping have the potential to help improve diet and health outcomes. Objective: This study aims to assess the feasibility and acceptability of receiving advice on healthier food purchases through SwapSHOP, a behaviorally informed smartphone app that allows users to scan barcodes of grocery products from the United Kingdom, providing nutritional information and personalized swap suggestions to encourage healthier purchases. Methods: We randomized adult volunteers in a 6-arm parallel-group controlled feasibility trial. Participants used the SwapSHOP app to record their grocery shopping during a 2-week run-in period and were individually randomized in a 3:1 ratio to either intervention or control arms within 3 strata related to a nutrient of concern of their choice: saturated fat (SFA), sugar, or salt. Participants randomized to the intervention received the SwapSHOP app with a healthier swap function, goal setting, and personalized feedback. Participants in the control group were instructed to use a simpler version of the app to log all their food purchases without receiving any guidance or advice. The primary outcome was the feasibility of progression to a full trial, including app use and follow-up rates at 6 weeks. The secondary outcomes included other feasibility outcomes, process and qualitative measures, and exploratory effectiveness outcomes to assess changes in the nutrient content of the purchased foods. Results: A total of 112 participants were randomized into 3 groups: SFA (n=38 intervention and n=13 control), sugar (n=40 intervention and n=15 control), and salt (n=5 intervention and n=1 control, not analyzed). The 2 progression criteria were met for SFA and sugar: 81% (30/37) and 87% (34/39) of intervention participants in the SFA and sugar groups, respectively, used the app to obtain healthier swaps, and 89% (68/76) of intervention participants and 96% (23/24) of control participants completed follow-up by scanning all purchases over the follow-up period. The process and qualitative outcomes suggested that the intervention was acceptable and has the potential to influence shopping behaviors. There were reductions of −0.56 g per 100 g (95% CI −1.02 to −0.19) in SFA and −1 g per 100 g (95% CI −1.97 to −0.03) in total sugars across all food purchases in the intervention groups. Conclusions: People were willing to use the SwapSHOP app to help reduce sugar and SFA (but not salt) in their grocery shopping. Adherence and follow-up rates suggest that a full trial is feasible. Given the suggestive evidence indicating that the intervention resulted in reductions in sugars and SFA, a definitive trial is necessary to target improvements in health outcomes. Trial Registration: International Standard Randomised Controlled Trial Number ISRCTN13022312; https://doi.org/10.1186/ISRCTN13022312 %M 38206671 %R 10.2196/45854 %U https://mhealth.jmir.org/2024/1/e45854 %U https://doi.org/10.2196/45854 %U http://www.ncbi.nlm.nih.gov/pubmed/38206671 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e49331 %T A Closed-Loop Falls Monitoring and Prevention App for Multiple Sclerosis Clinical Practice: Human-Centered Design of the Multiple Sclerosis Falls InsightTrack %A Block,Valerie J %A Koshal,Kanishka %A Wijangco,Jaeleene %A Miller,Nicolette %A Sara,Narender %A Henderson,Kyra %A Reihm,Jennifer %A Gopal,Arpita %A Mohan,Sonam D %A Gelfand,Jeffrey M %A Guo,Chu-Yueh %A Oommen,Lauren %A Nylander,Alyssa %A Rowson,James A %A Brown,Ethan %A Sanders,Stephen %A Rankin,Katherine %A Lyles,Courtney R %A Sim,Ida %A Bove,Riley %+ Department of Neurology, University of California San Francisco Weill Institute, University of California San Francisco, Box 3126 1651 4th St, Room 612A, San Francisco, CA, 94143, United States, 1 (415) 353 2069, riley.bove@ucsf.edu %K digital health %K mobile tools %K falls %K prevention %K behavioral medicine %K implementation science %K closed-loop monitoring %K multiple sclerosis %K mobile phone %D 2024 %7 11.1.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Falls are common in people with multiple sclerosis (MS), causing injuries, fear of falling, and loss of independence. Although targeted interventions (physical therapy) can help, patients underreport and clinicians undertreat this issue. Patient-generated data, combined with clinical data, can support the prediction of falls and lead to timely intervention (including referral to specialized physical therapy). To be actionable, such data must be efficiently delivered to clinicians, with care customized to the patient’s specific context. Objective: This study aims to describe the iterative process of the design and development of Multiple Sclerosis Falls InsightTrack (MS-FIT), identifying the clinical and technological features of this closed-loop app designed to support streamlined falls reporting, timely falls evaluation, and comprehensive and sustained falls prevention efforts. Methods: Stakeholders were engaged in a double diamond process of human-centered design to ensure that technological features aligned with users’ needs. Patient and clinician interviews were designed to elicit insight around ability blockers and boosters using the capability, opportunity, motivation, and behavior (COM-B) framework to facilitate subsequent mapping to the Behavior Change Wheel. To support generalizability, patients and experts from other clinical conditions associated with falls (geriatrics, orthopedics, and Parkinson disease) were also engaged. Designs were iterated based on each round of feedback, and final mock-ups were tested during routine clinical visits. Results: A sample of 30 patients and 14 clinicians provided at least 1 round of feedback. To support falls reporting, patients favored a simple biweekly survey built using REDCap (Research Electronic Data Capture; Vanderbilt University) to support bring-your-own-device accessibility—with optional additional context (the severity and location of falls). To support the evaluation and prevention of falls, clinicians favored a clinical dashboard featuring several key visualization widgets: a longitudinal falls display coded by the time of data capture, severity, and context; a comprehensive, multidisciplinary, and evidence-based checklist of actions intended to evaluate and prevent falls; and MS resources local to a patient’s community. In-basket messaging alerts clinicians of severe falls. The tool scored highly for usability, likability, usefulness, and perceived effectiveness (based on the Health IT Usability Evaluation Model scoring). Conclusions: To our knowledge, this is the first falls app designed using human-centered design to prioritize behavior change and, while being accessible at home for patients, to deliver actionable data to clinicians at the point of care. MS-FIT streamlines data delivery to clinicians via an electronic health record–embedded window, aligning with the 5 rights approach. Leveraging MS-FIT for data processing and algorithms minimizes clinician load while boosting care quality. Our innovation seamlessly integrates real-world patient-generated data as well as clinical and community-level factors, empowering self-care and addressing the impact of falls in people with MS. Preliminary findings indicate wider relevance, extending to other neurological conditions associated with falls and their consequences. %M 38206662 %R 10.2196/49331 %U https://humanfactors.jmir.org/2024/1/e49331 %U https://doi.org/10.2196/49331 %U http://www.ncbi.nlm.nih.gov/pubmed/38206662 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e53671 %T Refining Cultural Adaptations of a Behavioral Intervention for Latino Caregivers of People Living With Dementia: Qualitative Interview Study in Washington State %A Garcia,Celeste N %A Duran,Miriana C %A Ramirez,Magaly %+ Department of Health Systems and Population Health, University of Washington, 3980 15th Avenue North East, Seattle, WA, 98195, United States, 1 2065439773, maggiera@uw.edu %K caregivers %K caregiver %K caregiving %K carer %K carers %K STAR-C %K STAR caregiver %K internet %K web-based %K online %K educational %K education %K family care %K family %K families %K informal care %K adaptation %K adaptations %K cultural %K culturally %K module %K modules %K training %K Hispanic %K Hispanics %K Spanish %K Latin %K Latina %K Latinas %K Latinos %K Latinx %K Latino %K dementia %K qualitative research %K Alzheimer disease %K qualitative %K Alzheimer %K experience %K experiences %K attitude %K attitudes %K opinion %K perception %K perceptions %K perspective %K perspectives %K aging %K older adults %K old age %K mental health %K neuro %K ageing %K geriatrics %K gerontology %K geriatric %K interview %K eHealth %K digital health %K alzheimers %K memory %K memory loss %K care giving %K Hispanic or Latino %K mobile phone %D 2024 %7 11.1.2024 %9 Original Paper %J JMIR Aging %G English %X Background:  In the United States, Latino caregivers of individuals with dementia face unique challenges and an elevated risk of adverse health outcomes. Despite the increasing prevalence of Alzheimer disease and related dementias among Latino adults, few evidence-based interventions are tailored to their cultural context. To address this gap, we examined the cultural adaptations required for the STAR caregivers (STAR-C) virtual intervention, an evidence-based intervention that educates family caregivers to manage behavioral and psychological symptoms of dementia. While STAR-C has shown effectiveness, neither the original in-person nor the virtual intervention considered the distinct experiences of Latino caregivers, who often bring culturally significant values into caregiving interactions. Objective: This study’s objective was to test and refine the preliminary cultural adaptations of the STAR-C web-based training modules for Latino caregivers of people living with dementia. Methods: Through qualitative interviews with 15 Latino caregivers in Washington State, we identified key adaptations to enhance the cultural relevance of the web-based training modules. Results: The interviews highlighted 4 main themes for adaptation: the delivery of the STAR-C web-based training modules, comprehensive dementia education, simplified problem-solving strategies, and prioritizing caregiver well-being. Conclusions: This study’s findings informed the development of culturally adapted STAR-C web-based training modules that aim to provide tailored support to Latino caregivers. While further research is needed to assess the efficacy of these adaptations, our work contributes to bridging the gap in dementia caregiving for Latino families, potentially reducing health disparities and enhancing health care services for this population. %M 38206663 %R 10.2196/53671 %U https://aging.jmir.org/2024/1/e53671 %U https://doi.org/10.2196/53671 %U http://www.ncbi.nlm.nih.gov/pubmed/38206663 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e46222 %T The Sukaribit Smartphone App for Better Self-Management of Type 2 Diabetes: Randomized Controlled Feasibility Study %A Josefsson,Cecilia %A Liljeroos,Thea %A Hellgren,Margareta %A Pöder,Ulrika %A Hedström,Mariann %A Olsson,Erik M G %+ Department of Public Health and Caring Sciences, Uppsala University, BMC, Husargatan 3, Uppsala, 751 22, Sweden, 46 18 471 66 72, cecilia.josefsson@pubcare.uu.se %K diabetes mellitus %K type 2 %K health behavior %K mobile health %K mobile application %K pilot study %K mobile app %K mHealth %K diabetes %K diabetic %K RCT %K randomized %K glycemic %K self care %K self management %K blood sugar %K T2D %K diabetes type 2 %K home-testing %K digital health %D 2024 %7 10.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: A new app, Sukaribit, was designed to enable contact between the caregiver and the patient with the intent to improve self-care and glycemic control (hemoglobin A1c [HbA1c]). Objective: This study investigated the feasibility of the study methodology and the intervention in preparation for a larger effectiveness study. Methods: Adults with type 2 diabetes were recruited in this randomized controlled feasibility study with a mixed methods design. The intervention group (n=28) tried Sukaribit for 2 months. They were encouraged to report blood glucose levels and medications, and they received feedback from a physician. The control group (n=31) received standard care. Both groups were evaluated with pre and postmeasurements of glycemic control (HbA1c), diabetes distress, physical activity, and self-care. Feasibility was evaluated against 5 progression criteria regarding recruitment, study methods, and active participation. Results: Of the 5 progression criteria, only 2 were met or partially met. The recruitment process exceeded expectations, and data collection worked well for self-reported data but not for HbA1c measured with a home testing kit. The participants were less active than anticipated, and the effect sizes were small. Only the number of blood glucose tests per day was positively affected by the intervention, with 0.6 more tests per day in the intervention group. Conclusions: Recruitment of participants to a future fully powered study may work with minor adjustments. The collection of HbA1c using home testing constituted a major problem, and an alternative strategy is warranted. Finally, the app was not used as intended. In order to proceed with a larger study, the app and study procedures need improvement. %M 38198200 %R 10.2196/46222 %U https://formative.jmir.org/2024/1/e46222 %U https://doi.org/10.2196/46222 %U http://www.ncbi.nlm.nih.gov/pubmed/38198200 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e48748 %T Costs and Cardiovascular Benefits of a Fourth-Generation Synchronous Telehealth Program on Mortality and Cardiovascular Outcomes for Patients With Atrial Fibrillation: Retrospective Cohort Study %A Chang,Hao-Yun %A Wu,Hui-Wen %A Hung,Chi-Sheng %A Chen,Ying-Hsien %A Huang,Ching-Chang %A Yang,Li-Tan %A Hwang,Shin-Tsyr %A Yu,Jiun-Yu %A Lee,Jen-Kuang %A Ho,Yi-Lwun %+ Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital, No. 7, Chung-Shan South Road, Taipei, 100, Taiwan, 886 2 23123456 ext 62152, b85401104@gmail.com %K atrial fibrillation %K cardiovascular death %K fourth-generation synchronous program %K ischemic stroke %K telehealth %D 2024 %7 8.1.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: The prevalence of atrial fibrillation (AF) continues to increase in modern aging society. Patients with AF are at high risk for multiple adverse cardiovascular events, including heart failure, stroke, and mortality. Improved medical care is needed for patients with AF to enhance their quality of life and limit their medical resource utilization. With advances in the internet and technology, telehealth programs are now widely used in medical care. A fourth-generation telehealth program offers synchronous and continuous medical attention in response to physiological parameters measured at home. Although we have previously shown the benefits of this telehealth program for some patients with a high risk of cardiovascular disease, its benefits for patients with AF remains uncertain. Objective: This study aims to investigate the benefits of participating in a fourth-generation telehealth program for patients with AF in relation to cardiovascular outcomes. Methods: This was a retrospective cohort study. We retrospectively searched the medical records database of a tertiary medical center in Northern Taiwan between January 2007 and December 2017. We screened 5062 patients with cardiovascular disease and enrolled 537 patients with AF, of which 279 participated in the telehealth program and 258 did not. Bias was reduced using the inverse probability of treatment weighting adjustment based on the propensity score. Outcomes were collected and analyzed, including all-cause readmission, admission for heart failure, acute coronary syndrome, ischemic stroke, systemic embolism, bleeding events, all-cause mortality, and cardiovascular death within the follow-up period. Total medical expenses and medical costs in different departments were also compared. Subgroup analyses were conducted on ischemic stroke stratified by several subgroup variables. Results: The mean follow-up period was 3.0 (SD 1.7) years for the telehealth group and 3.4 (SD 1.9) years for the control group. After inverse probability of treatment weighting adjustment, the patients in the telehealth program had significantly fewer ischemic strokes (2.0 vs 4.5 events per 100 person-years; subdistribution hazard ratio [SHR] 0.45, 95% CI 0.22-0.92) and cardiovascular deaths (2.5 vs 5.9 events per 100 person-years; SHR 0.43, 95% CI 0.18-0.99) at the follow-up. The telehealth program particularly benefited patients comorbid with vascular disease (SHR 0.11, 95% CI 0.02-0.53 vs SHR 1.16, 95% CI 0.44-3.09; P=.01 for interaction). The total medical expenses during follow-up were similar in the telehealth and control groups. Conclusions: This study demonstrated the benefits of participating in the fourth-generation telehealth program for patients with AF by significantly reducing their ischemic stroke risk while spending the same amount on medical expenses. %M 38190237 %R 10.2196/48748 %U https://www.jmir.org/2024/1/e48748 %U https://doi.org/10.2196/48748 %U http://www.ncbi.nlm.nih.gov/pubmed/38190237 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e49302 %T Short-Term Effect of a Health Promotion Intervention Based on the Electronic 12-Hour Dietary Recall (e-12HR) Smartphone App on Adherence to the Mediterranean Diet Among Spanish Primary Care Professionals: Randomized Controlled Clinical Trial %A Béjar,Luis María %A Mesa-Rodríguez,Pedro %A García-Perea,María Dolores %+ Department of Preventive Medicine and Public Health, Institute of Anatomy, School of Medicine, University of Seville, 3rd Floor, Sánchez-Pizjuán Avenue, Seville, 41009, Spain, 34 954551771, lmbprado@us.es %K primary care professionals %K Mediterranean diet %K smartphone applications %K smartphone apps %K health promotion %K Mediterranean diet adherence %K food group %D 2024 %7 8.1.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The World Health Organization has called for addressing the growing burden of noncommunicable diseases (NCDs) by promoting healthy lifestyles among the population. Regarding patient health, primary care professionals (PCPs) are the first line of care who can positively influence patients’ behavior and lifestyle habits. However, a significant percentage of PCPs do not lead a healthy lifestyle. Therefore, addressing their health behaviors may be the key to substantially increasing health promotion advice in general practice. The Mediterranean diet has been extensively studied, and there is strong evidence of it being a dietary pattern for the prevention of NCDs, in addition to its significant environmental, sociocultural, and local economics benefits. Objective: This study focused only on the dietary aspect of the PCPs’ lifestyle. The primary objective was to evaluate the effect of using the Electronic 12-Hour Dietary Recall (e-12HR) smartphone app to improve diet, specifically to promote adherence to the Mediterranean diet (AMD), among PCPs. The secondary objectives were to establish the usability of the e-12HR app and to determine AMD among PCPs. Methods: An individual-level randomized, controlled, and single-blind clinical trial was conducted with 2 parallel groups: a control group (CG), using the nonfeedback version of the e-12HR app, and an intervention group (IG), using the feedback version of the e-12HR app. The level of human involvement was fully automated through the use of the app. There was a 28-day follow-up period. Participants were PCPs (medicine or nursing) recruited offline at one of the selected primary care centers (Andalusia, Spain, Southern Europe), of both sexes, over 18 years old, possessing a smartphone, and having smartphone literacy. Results: The study response rate was 73% (71 of 97 PCPs), with 27 (38%) women and 44 (62%) men: 40 (56%) PCPs in the CG and 31 (44%) in the IG. At baseline, AMD was medium (mean Mediterranean Diet Serving Score [MDSS] index 9.45, range 0-24), with 47 (66%) PCPs with a medium/high MDSS index. There were significant statistical improvements (CG vs IG, in favor of the IG) at week 4 (no significant statistical differences at baseline): +25.6% for the MDSS index (P=.002) and +213.1% for the percentage with a medium/high MDSS index (P=.001). In relation to specific food groups, there were significant statistical improvements for fruits (+33.8%, P=.02), vegetables (+352%, P=.001), nuts (+184%, P=.02), and legumes (+75.1%, P=.03). The responses to the usability rating questionnaire were satisfactory. Conclusions: The results support recommending the use of the e-12HR app as a tool to contribute to improving diet and preventing NCDs among PCPs, while positively influencing patient dietary behavior and preventing diet-related NCDs among patients. Trial Registration: ClinicalTrials.gov NCT05532137; https://clinicaltrials.gov/study/NCT05532137 %M 38190226 %R 10.2196/49302 %U https://mhealth.jmir.org/2024/1/e49302 %U https://doi.org/10.2196/49302 %U http://www.ncbi.nlm.nih.gov/pubmed/38190226 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e52969 %T Remote Delivery of the Cuidándome Telehealth Intervention for Self-Management of Depression and Anxiety Among Latina Immigrant Women: Randomized Controlled Trial %A Alvarez,Carmen %A Aryal,Subhash %A Vrany,Elizabeth %A Sanchez R,Maria Jose %A Quiles,Rosalphie %A Escobar-Acosta,Lia %A Hill-Briggs,Felicia %+ School of Nursing, University of Pennsylvania, 418 Curie Boulevard, Philadelphia, PA, 19104, United States, 1 2158980715, alcarmen@nursing.upenn.edu %K Latina immigrant %K mental health %K depression %K anxiety %K problem-solving %K intervention study %K trauma-informed %K depressive %K Latinx %K Latin %K Latino %K Latina %K Hispanic %K Spanish %K immigrant %K immigrants %K survivor %K child %K children %K childhood %K trauma %K traumatic %K adverse %K telehealth %K telemedicine %K eHealth %K digital health %K feasibility %K acceptability %K randomized %K controlled trial %K controlled trials %K mobile phone %D 2024 %7 8.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Growing evidence suggests that Latina immigrant survivors of adverse childhood experiences (ACEs) are at increased risk for developing and remaining with either depression or anxiety or both symptoms. This study examined the feasibility and acceptability of a telehealth intervention—Cuidándome (quee-DAN-doh-meh, “taking care of myself”). Cuidándome is a 10-week, patient-centered, trauma-informed intervention delivered by a trained facilitator that promotes self-management of depression and anxiety symptoms through improved problem-solving skills and strategies. Objective: The aim of this study was to examine the feasibility and acceptability of Cuidándome delivered remotely (via Zoom) with Latina immigrant ACE survivors with either depression or anxiety or both symptoms. We also estimated the effect sizes associated with the intervention on decreasing depression and anxiety symptoms and improving social problem–solving styles. Methods: We evaluated Cuidándome using a randomized controlled trial design. Latina immigrants (N=47) who had experienced at least 1 ACE and had at least mild depression or anxiety symptoms were randomized to Cuidándome or a comparison group delivered by trained facilitators. We assessed for changes in depression and anxiety symptoms as well as social problem–solving styles at baseline, post intervention, and 3- and 6-month follow-up. Results: Analyses indicated significant decreases over time within both Cuidándome and comparison groups for depression and anxiety symptoms and maladaptive problem-solving. The intervention effect was largest for anxiety; at 6-month follow-up, Cuidándome participants had significantly lower anxiety scores than the comparison group. In addition, we observed a greater average point reduction in depression symptoms at 6 months among Cuidándome participants (5.7 points) than in the comparison group (3.7 points). Conclusions: A mental health program delivered via Zoom by a trained facilitator was feasible and acceptable to Latina immigrant women and can be beneficial for reducing anxiety and depression symptoms. More research is needed to assess the effectiveness of Cuidándome among a powered sample size of Latina immigrants. Trial Registration: ISRCTN Registry ISRCTN16668518; https://www.isrctn.com/ISRCTN16668518 %M 38190239 %R 10.2196/52969 %U https://formative.jmir.org/2024/1/e52969 %U https://doi.org/10.2196/52969 %U http://www.ncbi.nlm.nih.gov/pubmed/38190239 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e49705 %T Adaptive Intervention to Prevent Respiratory Illness in Cerebral Palsy: Protocol for a Feasibility Pilot Randomized Controlled Trial %A Fleischman,Alyssa %A Lerner,Carlos %A Kloster,Heidi %A Chung,Paul %A Klitzner,Thomas %A Cushing,Christopher %A Gerber,Danielle %A Katz,Barbara %A Warner,Gemma %A Singh-Verdeflor,Kristina Devi %A Delgado-Martinez,Roxana %A Porras-Javier,Lorena %A Ia,Siem %A Wagner,Teresa %A Ehlenbach,Mary %A Coller,Ryan %+ Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, H6/551 CSC, 600 Highland Ave, Madison, WI, 53792, United States, 1 608 262 9150, afleischman2@wisc.edu %K just-in-time adaptive intervention %K respiratory illness %K cerebral palsy %K action planning %K digital health %D 2024 %7 8.1.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: This study will pilot-test an innovative just-in-time adaptive intervention to reduce severe respiratory illness among children with severe cerebral palsy (CP). Our intervention program, Respiratory Exacerbation–Plans for Action and Care Transitions (RE-PACT), delivers timely customized action planning and rapid clinical response when hospitalization risk is elevated. Objective: This study aims to establish RE-PACT’s feasibility, acceptability, and fidelity in up to 90 children with severe CP. An additional aim is to preliminarily estimate RE-PACT’s effect size. Methods: The study will recruit up to 90 caregivers of children with severe CP aged 0 to 17 years who are cared for by a respiratory specialist or are receiving daily respiratory treatments. Participants will be recruited from pediatric complex care programs at the University of Wisconsin–Madison (UW) and the University of California, Los Angeles (UCLA). Study participants will be randomly assigned to receive usual care through the complex care clinical program at UW or UCLA or the study intervention, RE-PACT. The intervention involves action planning, rapid clinical response to prevent and manage respiratory illness, and weekly SMS text messaging surveillance of caregiver confidence for their child to avoid hospitalization. RE-PACT will be run through 3 successively larger 6-month trial waves, allowing ongoing protocol refinement according to prespecified definitions of success for measures of feasibility, acceptability, and fidelity. The feasibility measures include recruitment and intervention time. The acceptability measures include recruitment and completion rates as well as intervention satisfaction. The fidelity measures include observed versus expected rates of intervention and data collection activities. The primary clinical outcome is a severe respiratory illness, defined as a respiratory diagnosis requiring hospitalization. The secondary clinical outcomes include hospital days and emergency department visits, systemic steroid courses, systemic antibiotic courses, and death from severe respiratory illness. Results: The recruitment of the first wave began on April 27, 2022. To date, we have enrolled 30 (33%) out of 90 participants, as projected. The final wave of recruitment will end by October 31, 2023, and the final participant will complete the study by April 30, 2024. We will start analyzing the complete responses by April 30, 2024, and the publication of results is expected at the end of 2024. Conclusions: This pilot intervention, using adaptive just-in-time strategies, represents a novel approach to reducing the incidence of significant respiratory illness for children with severe CP. This protocol may be helpful to other researchers and health care providers caring for patients at high risk for acute severe illness exacerbations. Trial Registration: ClinicalTrials.gov NCT05292365; https://clinicaltrials.gov/study/NCT05292365 International Registered Report Identifier (IRRID): DERR1-10.2196/49705 %M 38190242 %R 10.2196/49705 %U https://www.researchprotocols.org/2024/1/e49705 %U https://doi.org/10.2196/49705 %U http://www.ncbi.nlm.nih.gov/pubmed/38190242 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e47361 %T Exploring the Potential of a Behavior Theory–Informed Digital Intervention for Infant Fall Prevention: Mixed Methods Longitudinal Study %A Cooray,Nipuna %A Ho,Catherine %A Bestman,Amy %A Adams,Susan %A Nassar,Natasha %A Keay,Lisa %A Brown,Julie %+ The George Institute for Global Health, Faculty of Medicine and Health, University of New South Wales Sydney, Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo, 2000, Australia, 61 468311723, ncooray@georgeinstitute.org.au %K child injury %K digital behavior change interventions %K user experience %K falls %K infant fall %K injury %K mobile app %K digital intervention %K users %K mixed methods longitudinal study %K behavior %K development %K fall risk %K fall prevention %K acceptability %K app %K children %K internet %K parents %K maternal, paternal %K accidents %K infancy %K infant %K accidental fall %K accidental falls %K infant behavior %K longitudinal design %K mixed methods %K parent %K mobile phone %D 2024 %7 3.1.2024 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Falls are the most common hospitalized injury mechanism in children aged ≤1 years, and currently, there are no targeted prevention interventions. The prevention of falls in children of this age requires changes in the behavior of their caregivers, and theoretically informed digital behavior change interventions (DBCIs) may provide a unique mechanism for achieving effective intervention. However, user acceptance and the ability of DBCIs to effect the required changes in behavior are critical to their likelihood of success. Objective: This study aims to evaluate a behavior theory–informed digital intervention developed following a user-centered approach for user experience, the potential for this intervention to prevent infant falls, and its impact on behavioral drivers underpinning fall risk in young children. Methods: Parents of infants aged <1 year were recruited and asked to use the intervention for 3 months. A pre-post longitudinal design was used to examine the change in the potential to reduce the risk of falls after a 3-month exposure to the intervention. Postintervention data on behavioral drivers for fall prevention, user acceptability, and engagement with the app were also collected. Interviews were conducted to explore user experiences and identify areas for further improvement of the intervention. Results: A total of 62 parents participated in the study. A statistically significant effect on the potential to reduce falls was observed after the intervention. This effect was higher for new parents. Parents agreed that the intervention targeted most of the target behavior drivers. The impact of behavior drivers and intervention on the potential for fall prevention had a positive correlation. The intervention demonstrated good levels of acceptability. Feedback from participants was mostly positive, and the primary area identified for further improvement was widening the scope of the intervention. Conclusions: This study demonstrated the promise of a newly developed digital intervention to reduce the risk of infant falls, particularly among new parents. It also showed a positive influence of the DBCI on the drivers of parental behaviors that are important for fall reduction among infants. The acceptability of the app was high, and important insights were gained from users about how to further improve the app. %M 38170580 %R 10.2196/47361 %U https://pediatrics.jmir.org/2024/1/e47361 %U https://doi.org/10.2196/47361 %U http://www.ncbi.nlm.nih.gov/pubmed/38170580 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e47006 %T Digital Phenotyping for Mood Disorders: Methodology-Oriented Pilot Feasibility Study %A Breitinger,Scott %A Gardea-Resendez,Manuel %A Langholm,Carsten %A Xiong,Ashley %A Laivell,Joseph %A Stoppel,Cynthia %A Harper,Laura %A Volety,Rama %A Walker,Alex %A D'Mello,Ryan %A Byun,Andrew Jin Soo %A Zandi,Peter %A Goes,Fernando S %A Frye,Mark %A Torous,John %+ Department of Psychiatry and Psychology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, United States, 1 5072845233, breitinger.scott@mayo.edu %K mood disorders %K depression %K bipolar disorder %K digital health %K digital phenotyping %K mobile apps %K patient-generated health data %K wearable devices %D 2023 %7 29.12.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: In the burgeoning area of clinical digital phenotyping research, there is a dearth of literature that details methodology, including the key challenges and dilemmas in developing and implementing a successful architecture for technological infrastructure, patient engagement, longitudinal study participation, and successful reporting and analysis of diverse passive and active digital data streams. Objective: This article provides a narrative rationale for our study design in the context of the current evidence base and best practices, with an emphasis on our initial lessons learned from the implementation challenges and successes of this digital phenotyping study. Methods: We describe the design and implementation approach for a digital phenotyping pilot feasibility study with attention to synthesizing key literature and the reasoning for pragmatic adaptations in implementing a multisite study encompassing distinct geographic and population settings. This methodology was used to recruit patients as study participants with a clinician-validated diagnostic history of unipolar depression, bipolar I disorder, or bipolar II disorder, or healthy controls in 2 geographically distinct health care systems for a longitudinal digital phenotyping study of mood disorders. Results: We describe the feasibility of a multisite digital phenotyping pilot study for patients with mood disorders in terms of passively and actively collected phenotyping data quality and enrollment of patients. Overall data quality (assessed as the amount of sensor data obtained vs expected) was high compared to that in related studies. Results were reported on the relevant demographic features of study participants, revealing recruitment properties of age (mean subgroup age ranged from 31 years in the healthy control subgroup to 38 years in the bipolar I disorder subgroup), sex (predominance of female participants, with 7/11, 64% females in the bipolar II disorder subgroup), and smartphone operating system (iOS vs Android; iOS ranged from 7/11, 64% in the bipolar II disorder subgroup to 29/32, 91% in the healthy control subgroup). We also described implementation considerations around digital phenotyping research for mood disorders and other psychiatric conditions. Conclusions: Digital phenotyping in affective disorders is feasible on both Android and iOS smartphones, and the resulting data quality using an open-source platform is higher than that in comparable studies. While the digital phenotyping data quality was independent of gender and race, the reported demographic features of study participants revealed important information on possible selection biases that may result from naturalistic research in this domain. We believe that the methodology described will be readily reproducible and generalizable to other study settings and patient populations given our data on deployment at 2 unique sites. %M 38157233 %R 10.2196/47006 %U https://www.jmir.org/2023/1/e47006 %U https://doi.org/10.2196/47006 %U http://www.ncbi.nlm.nih.gov/pubmed/38157233 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e51658 %T Effectiveness of the QuitSure Smartphone App for Smoking Cessation: Findings of a Prospective Single Arm Trial %A Pandya,Apurvakumar %A K S,Mythri %A Mishra,Shweta %A Bajaj,Kriti %+ Parul Institute of Public Health, Parul University, At & Post - Limda, Waghodia, Vadodara, 391760, India, 91 9825558237, drapurvakumar@gmail.com %K smoking %K nicotine dependence %K smoking cessation %K QuitSure app %K smartphone application %K mHealth %K mobile health %K app %K apps %K application %K applications %K nicotine %K smoke %K smoker %K quit %K quitting %K cessation %K abstinence %K mobile phone %D 2023 %7 29.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital therapies, especially smartphone apps for active and continuous smoking cessation support, are strongly emerging as an alternative smoking cessation therapy. In the Indian context, there is a growing interest in the use of app-based smoking cessation programs; however, there is limited evidence regarding their effectiveness in achieving long-term continuous abstinence. Objective: This study aimed to evaluate the long-term abstinence effect (up to 30-d abstinence postprogram completion) of a smartphone app, QuitSure, for smoking cessation in active smokers from India. Methods: In this prospective single-arm study, participants who signed up for the QuitSure app were enrolled in this study. The primary end point was the prolonged abstinence (PA) rate from weeks 1 to 4 (day 7 to day 30). Furthermore, data for withdrawal symptoms, relapse reasons, and reasons for not continuing the program were also assessed. Results: The quit rate was calculated considering only the participants who followed up and completed the survey sent to them (per protocol) at day 7 and at day 30, respectively. The PA rate at day 7 was found to be 64.5% (111/172; 95% CI 56% to 72%), and the PA rate at day 30 was found to be 55.8% (72/129; 95% CI 45% to 65%). Within the 7-day abstinence period, 60.4% (67/111) of the participants did not have any withdrawal symptoms. The most common mild withdrawal symptoms were mild sleep disturbance (21/111, 18.9%), mild digestive changes (19/111, 17.1%), and coughing (17/111, 15.3%). Severe withdrawal symptoms were rare, with only 5.4% (6/111) experiencing them. For those achieving 30-day postprogram abstinence, 85% (61/72) had no mild withdrawal symptoms, and 99% (71/72) had no severe withdrawal symptoms. Among successful quitters at day 7, a total of 72.1% (80/111) reported minimal to no cravings, which increased to 88% (63/72) at day 30. Furthermore, 78% (56/72) of those with PA at day 30 reported no change in weight or reduced weight. Among participants experiencing relapse, 48% (28/58) cited intense cravings, 28% (16/58) mentioned facing a tragedy, and 26% (15/58) reported relapsing due to alcohol consumption. The PA rates as a result of the QuitSure program were found to be better than those reported in the results of other smoking-cessation app programs’ studies. Conclusions: The QuitSure app yields high PA rates and ameliorates symptoms associated with smoking cessation. In order to obtain conclusive evidence regarding the effectiveness and efficacy of the QuitSure program, future research should include appropriate control measures. Nevertheless, the QuitSure program can serve as a valuable adjunct to a conventional smoking cessation treatment program to aid sustained abstinence. %M 38157243 %R 10.2196/51658 %U https://formative.jmir.org/2023/1/e51658 %U https://doi.org/10.2196/51658 %U http://www.ncbi.nlm.nih.gov/pubmed/38157243 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45905 %T Implementation Considerations for Family-Based Telehealth Interventions for Youth in Foster Care: Focus Group Study With Child Welfare System Professionals %A Leo,Hannah P %A Folk,Johanna B %A Rodriguez,Christopher %A Tolou-Shams,Marina %+ Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, 675 18th St., San Francisco, CA, 94143, United States, 1 4154767000, Marina.Tolou-Shams@ucsf.edu %K foster youth %K telehealth %K family-based interventions %K mental health %D 2023 %7 29.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Between 2016 and 2020, over 600,000 youth were served annually by the foster care system. Despite approximately half of foster youth struggling with emotional or behavioral challenges, few receive much-needed services to address their mental health concerns. Family-based interventions are efficacious in addressing both youth and caregiver mental health needs; however, foster youth participation in these family-based interventions is limited by many barriers, including out-of-home placement far from their family of origin. Telehealth is a promising tool for mitigating barriers to access to treatment interventions for foster youth and their families. Objective: This study aims to understand child welfare system professionals’ perspectives on enabling factors and barriers to providing family-based interventions via telehealth to youth in out-of-county foster care placement. Methods: This qualitative study derived themes from 3 semistructured focus groups with child welfare system professionals. Participants were asked to discuss how family-based interventions are delivered to foster youth and their caregivers in their jurisdictions, as well as to share their thoughts about how to use telehealth to improve access to family-based interventions for families with youth in out-of-home placement. Data were analyzed using constant comparative analysis and inductive thematic analysis, with the Behavioral Model for Vulnerable Populations as the theoretical framework. Results: Participants were 19 child welfare system professionals (eg, social workers, residential treatment staff, and supervisors) who participated in 1 of the 3 focus groups (6-7/group). Most participants were women (n=13, 68%), White individuals (n=10, 53%), and social workers (n=8, 42%). On average, participants worked in the child welfare system for 16.6 (SD 8.3) years. Participants identified multilevel factors impacting family-based intervention delivery including environmental factors (eg, Medicare billing and presumptive transfer), predisposing characteristics (eg, psychological resources), enabling factors (eg, transportation and team-based youth-centered care), and need factors (eg, motivation to engage). Participants expressed optimism that telehealth could increase access to needed mental health care, diverse providers, and longevity of care while also expressing some concerns regarding telehealth access and literacy. Conclusions: Child welfare system professionals highlight the need to develop policies and telehealth interventions that are youth versus placement centered, include resources that limit barriers and bolster motivation for engagement, and follow a team-based care model. Findings from this study inform how telehealth can be used to increase access to and engagement with family-based interventions for youth in out-of-home placements and their caregivers of origin. %M 38157238 %R 10.2196/45905 %U https://formative.jmir.org/2023/1/e45905 %U https://doi.org/10.2196/45905 %U http://www.ncbi.nlm.nih.gov/pubmed/38157238 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e52799 %T Bio-Experiential Technology to Support Persons With Dementia and Care Partners at Home (TEND): Protocol for an Intervention Development Study %A Rochon,Elizabeth A %A Sy,Maimouna %A Phillips,Mirelle %A Anderson,Erik %A Plys,Evan %A Ritchie,Christine %A Vranceanu,Ana-Maria %+ Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, 1 Bowdoin Square, Boston, MA, 02114, United States, 1 617 724 4977, avranceanu@mgh.harvard.edu %K dementia %K dyadic %K bio-experiential %K serious gaming %K psychosocial %D 2023 %7 29.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Alzheimer disease and related dementias are debilitating and incurable diseases. Persons with dementia and their informal caregivers (ie, dyads) experience high rates of emotional distress and negative health outcomes. Several barriers prevent dyads from engaging in psychosocial care including cost, transportation, and a lack of treatments that target later stages of dementia and target the dyad together. Technologically informed treatment and serious gaming have been shown to be feasible and effective among persons living with dementia and their care partners. To increase access, there is a need for technologically informed psychosocial interventions which target the dyad, together in the home. Objective: This study aims to develop the toolkit for experiential well-being in dementia, a dyadic, “bio-experiential” intervention for persons with dementia and their caregivers. Per our conceptual model, the toolkit for experiential well-being in dementia platform aims to target sustained attention, positive emotions, and active engagement among dyads. In this paper, we outline the protocol and conceptual model for intervention development and partnership with design and development experts. Methods: We followed the National Institutes of Health (NIH) stage model (stage 1A) and supplemented the model with principles of user-centered design. The first step includes understanding user needs, goals, and strengths. We met this step by engaging in methodology and definition synthesis and conducting focus groups with dementia care providers (N=10) and persons with dementia and caregivers (N=11). Step 2 includes developing and refining the prototype. We will meet this step by engaging dyads in up to 20 iterations of platform β testing workshops. Step 3 includes observing user interactions with the prototype. We will meet this step by releasing the platform for feasibility testing. Results: Key takeaways from the focus groups include balancing individualization and the dyadic relationship and avoiding confusing stimuli. As of September 2023, we have completed focus groups with providers, persons with dementia, and their caregivers. Additionally, we have conducted 4 iterations of β testing workshops with dyads. Feedback from focus groups informed the β testing workshops; data have not yet been formally analyzed and will be reported in future publications. Conclusions: Technological interventions, particularly “bio-experiential” technology, can be used in dementia care to support emotional health among persons with a diagnosis and caregivers. Here, we outline a collaborative intervention development process of bio-experiential technology through a research, design, and development partnership. Next, we are planning to test the platform’s feasibility as well as its impact on clinical outcomes and mechanisms of action. International Registered Report Identifier (IRRID): DERR1-10.2196/52799 %M 38157239 %R 10.2196/52799 %U https://www.researchprotocols.org/2023/1/e52799 %U https://doi.org/10.2196/52799 %U http://www.ncbi.nlm.nih.gov/pubmed/38157239 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e52117 %T Improving Health for Older Adults With Pain Through Engagement: Protocol for Tailoring and Open Pilot Testing of a Mind-Body Activity Program Delivered Within Shared Medical Visits in an Underserved Community Clinic %A McDermott,Katherine %A Levey,Nadine %A Brewer,Julie %A Ehmann,Madison %A Hooker,Julia E %A Pasinski,Roger %A Yousif,Neda %A Raju,Vidya %A Gholston,Milton %A Greenberg,Jonathan %A Ritchie,Christine S %A Vranceanu,Ana-Maria %+ Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, Suite 100, Boston, MA, 02114, United States, 1 617 724 4977, avranceanu@mgh.harvard.edu %K chronic pain %K mind-body %K underserved %K musculoskeletal pain %K pain %K older adults %K pain management %K feasibility %K intervention %D 2023 %7 29.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic musculoskeletal pain is prevalent and disabling among older adults in underserved communities. Psychosocial pain management is more effective than pharmacological treatment in older adults. However, underserved community clinics often lack psychosocial treatments, in part because of a lack of trained providers. Shared medical appointments, in which patients undergo brief medical evaluation, monitoring, counseling, and group support, are an efficacious and cost-effective method for chronic disease management in underserved clinics, reducing the need for specialized providers. However, shared medical visits are often ineffective for chronic pain, possibly owing to lack of inclusion of skills most relevant for older adults (eg, pacing to increase engagement in daily activities). Objective: We have described the protocol for the development and initial pilot effectiveness testing of the GetActive+ mind-body activity intervention for older adults with chronic pain. GetActive+ was adapted from GetActive, an evidence-based intervention that improved pain outcomes among mostly affluent White adults. We aim to establish the initial feasibility, acceptability, fidelity, and effectiveness of GetActive+ when delivered as part of shared medical appointments in a community clinic. Methods: We conducted qualitative focus groups and individual interviews with providers (n=25) and English-speaking older adults (aged ≥55 y; n=18) with chronic pain to understand the pain experience in this population, perceptions about intervention content, and barriers to and facilitators of intervention participation and implementation in this setting. Qualitative interviews with Spanish-speaking older adults are in progress and will inform a future open pilot of the intervention in Spanish. We are currently conducting an open pilot study with exit interviews in English (n=30 individuals in total). Primary outcomes are feasibility (≥75% of patients who are approached agree to participate), acceptability (≥75% of patients who enrolled complete 8 out of 10 sessions; qualitative), and fidelity (≥75% of session components are delivered as intended). Secondary outcomes include physical function—self-reported, performance based (6-minute walk test), and objective (step count)—and emotional function (depression and anxiety). Other assessments include putative mechanisms (eg, mindfulness and pain catastrophizing). Results: We began enrolling participants for the qualitative phase in November 2022 and the open pilot phase in May 2023. We completed the qualitative phase with providers and English-speaking patients, and the results are being analyzed using a hybrid, inductive-deductive approach. We conducted rapid analysis of these data to develop GetActive+ before the open pilot in English, including increasing readability and clarity of language, reducing the number of skills taught to increase time for individual check-ins and group participation, and increasing experiential exercises for skill uptake. Conclusions: We provide a blueprint for the refinement of a mind-body activity intervention for older adults with chronic pain in underserved community clinics and for incorporation within shared medical visits. It will inform a future, fully powered, effectiveness-implementation trial of GetActive+ to help address the chronic pain epidemic among older adults. Trial Registration: ClinicalTrials.gov NCT05782231; https://clinicaltrials.gov/study/NCT05782231 International Registered Report Identifier (IRRID): DERR1-10.2196/52117 %M 38157234 %R 10.2196/52117 %U https://www.researchprotocols.org/2023/1/e52117 %U https://doi.org/10.2196/52117 %U http://www.ncbi.nlm.nih.gov/pubmed/38157234 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e54284 %T Exploring Generation Z and Young Millennials’ Perspectives of a Spiritual Self-Care App and Their Spiritual Identity (Skylight): Qualitative Semistructured Interview Study %A Park,Susanna Y %A Yourell,Jacqlyn %A McAlister,Kelsey L %A Huberty,Jennifer %+ Skylight, Radiant Foundation, 55 N 300 W Suite 800, Salt Lake City, UT, 84101, United States, 1 720 675 7228, syjpark@gmail.com %K Gen Z %K Generation Z %K millennial %K GenZennials %K millennials %K young adult %K young adults %K spirituality %K spiritual %K self-care %K mental health %K sleep %K mobile health %K app %K apps %K digital health %K experience %K experiences %K attitude %K attitudes %K opinion %K perception %K perceptions %K perspective %K perspectives %K acceptance %K interview %K interviews %K thematic analysis %K mobile phone %D 2023 %7 28.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Generation Z and young millennials (ages 18-35 years), collectively referred to as GenZennials, are connected to technology and the internet like no other generation before them. This has mental health implications, such as increased rates of anxiety and stress. Recent research has shown that app-based mental health interventions can be useful to address such mental health concerns. However, spirituality is an untapped resource, especially since GenZennials largely identify as spiritual and already integrate spiritual practices into their self-care. Objective: There were four objectives to this study: (1) comprehensively explore reasons why GenZennials use a spiritual self-care app (ie, Skylight; Radiant Foundation), (2) understand how GenZennials identify spiritually, (3) understand the app’s relevance to GenZennials, and (4) gather feedback and suggestions to improve the app. Methods: Semistructured interviews were conducted with 23 GenZennials (ages 18-35 years; mean 28.7, SD 5.0 years; n=20, 87% female) who used the Skylight app. Interviews were 30 to 60 minutes and conducted on Zoom. Thematic analysis was used to analyze interviews. Results: Five major categories emerged from the analysis, each encompassing one to several themes: (1) reasons for using the Skylight app, (2) content favorites, (3) defining spiritual identity, (4) relevance to GenZennials, and (5) overall improvement recommendations. Participants used the app for various reasons including to relax, escape, or ground themselves; improve mood; and enhance overall health and wellness. Participants also cited the app’s variety of content offerings and its free accessibility as their primary reasons for using it. Most participants identified themselves as solely spiritual (8/23/35%) among the options provided (ie, spiritual or religious or both), and they appreciated the app’s inclusive content. Participants felt that the app was relevant to their generation as it offered modern content (eg, spiritual self-care activities and short content). Participants recommended adding more personalization capabilities, content, and representation to the app. Conclusions: This is the first study to qualitatively explore GenZennials’ perspectives and the use of a spiritual self-care app. Our findings should inform the future creation and improvement of spiritual self-care apps aimed at cultivating GenZennials’ spiritual and mental well-being. Future research is warranted to examine the effects of using a spiritual self-care app on GenZennial mental health. %M 38064199 %R 10.2196/54284 %U https://formative.jmir.org/2023/1/e54284 %U https://doi.org/10.2196/54284 %U http://www.ncbi.nlm.nih.gov/pubmed/38064199 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e53619 %T A Remotely Delivered, Semaglutide-Supported Specialist Weight Management Program: Preliminary Findings From a Retrospective Service Evaluation %A Richards,Rebecca %A Wren,Gina M %A Campion,Peta %A Whitman,Michael %+ Second Nature, 483 Green Lanes, London, N13 4BS, United Kingdom, 44 020 3488 076, becky@secondnature.io %K digital health intervention %K smartphone %K obesity management %K medication %K mobile phone %D 2023 %7 28.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital weight management interventions have the potential to increase access to novel pharmacotherapy for people living with obesity. At present, there is limited real-world evidence on the effectiveness, feasibility, and acceptability of this type of intervention. Objective: This retrospective service evaluation examines real-world data to evaluate the preliminary impact of Second Nature’s 24-month, remotely delivered, semaglutide-supported weight management intervention for adults living with obesity at 12 weeks. Methods: Retrospective data were extracted in October 2023 for participants who started the intervention between June 8, 2023, and July 22, 2023. The primary outcomes were weight change (kg) and percentage of weight change at 12 weeks. The secondary outcomes were the proportion of participants who achieved ≥5% and ≥10% weight loss and the feasibility and acceptability of this type of intervention. Descriptive statistics were used to evaluate the baseline characteristics, retention, engagement, prevalence of side effects, and weight change. A paired 2-tailed t test was used to determine the significance of weight change. Content analysis was used to analyze the free-text questionnaire responses. Results: A total of 113 participants with a mean baseline BMI of 38.4 kg/m2 (SD 7.3) were included in the analysis (n=102, 90.4% women, mean age 46.6, SD 11.1 years). Over 12 weeks, 23% (n=26) of participants withdrew from the intervention. A total of 70.8% (n=80) of participants provided weight data at 12 weeks. The average weight loss observed over this 12-week period was 6.5 (SD 4.4) kg (P<.001) or 6.4% (SD 4.2%) of their starting weight (P<.001). Of the 80 participants who recorded weight readings, 62.5% (n=50) achieved ≥5% weight loss, and 11.3% (n=9) achieved ≥10% weight loss. Engagement with the app-based program declined from a mean of 131 (SD 142.6) home screen views in week 0 to 35 (SD 57.1) in week 11. Common side effects reported over 12 weeks included feeling more tired than usual, constipation, and feeling sick. However, a significant proportion of participants reported no side effects. Most participants (n=106, 93.8%) did not experience any difficulties in medication administration. Qualitative data showed that most participants had a positive or neutral experience of the intervention, with some reporting perceived benefits as early as 4 weeks. Most participants did not feel that improvements in the intervention were needed; however, some participants faced issues with medication shipping or logistics. Conclusions: This retrospective preliminary service evaluation suggests that a remotely delivered semaglutide-supported weight management intervention has the potential to be effective, feasible, and acceptable for self-paying consumer adults with obesity in the United Kingdom. Areas for further improvement were highlighted, including user engagement in an app-based program. A full-service evaluation at the end of the 24-month intervention with a larger sample size is required to support these early findings. %M 38153780 %R 10.2196/53619 %U https://formative.jmir.org/2023/1/e53619 %U https://doi.org/10.2196/53619 %U http://www.ncbi.nlm.nih.gov/pubmed/38153780 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e52872 %T Follow-Up of Patients With Axial Spondyloarthritis in Specialist Health Care With Remote Monitoring and Self-Monitoring Compared With Regular Face-to-Face Follow-Up Visits (the ReMonit Study): Protocol for a Randomized, Controlled Open-Label Noninferiority Trial %A Berg,Inger Jorid %A Tveter,Anne Therese %A Bakland,Gunnstein %A Hakim,Sarah %A Kristianslund,Eirik K %A Lillegraven,Siri %A Macfarlane,Gary J %A Moholt,Ellen %A Provan,Sella A %A Sexton,Joseph %A Thomassen,Emil EK %A De Thurah,Annette %A Gossec,Laure %A Haavardsholm,Espen A %A Østerås,Nina %+ Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Box 23 Vinderen, Oslo, 0319, Norway, 47 92047212, ingerjoridberg@gmail.com %K spondyloarthritis %K inflammatory joint disease %K telemedicine %K remote monitoring %K remote care %K self-management %K randomized controlled trial %K cost-effectiveness %D 2023 %7 27.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Patients with chronic inflammatory joint diseases such as axial spondyloarthritis have traditionally received regular follow-up in specialist health care to maintain low disease activity. The follow-up has been organized as prescheduled face-to-face visits, which are time-consuming for both patients and health care professionals. Technology has enabled the remote monitoring of disease activity, allowing patients to self-monitor their disease and contact health care professionals when needed. Remote monitoring or self-monitoring may provide a more personalized follow-up, but there is limited research on how these follow-up strategies perform in maintaining low disease activity, patient satisfaction, safety, and cost-effectiveness. Objective: The Remote Monitoring in Axial Spondyloarthritis (ReMonit) study aimed to assess the effectiveness of digital remote monitoring and self-monitoring in maintaining low disease activity in patients with axial spondyloarthritis. Methods: The ReMonit study is a 3-armed, single-site, randomized, controlled, open-label noninferiority trial including patients with axial spondyloarthritis with low disease activity (Ankylosing Spondylitis Disease Activity Score <2.1) and on stable treatment with a tumor necrosis factor inhibitor. Participants were randomized 1:1:1 to arm A (usual care, face-to-face visits every sixth month), arm B (remote monitoring, monthly digital registration of patient-reported outcomes), or arm C (patient-initiated care, self-monitoring, no planned visits during the study period). The primary end point was disease activity measured with the Ankylosing Spondylitis Disease Activity Score, evaluated at 6, 12, and 18 months. We aimed to include 240 patients, 80 in each arm. Secondary end points included other measures of disease activity, patient satisfaction, safety, and cost-effectiveness. Results: The project is funded by the South-Eastern Norway Regional Health Authority and Centre for the treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Norway. Enrollment started in September 2021 and was completed with 242 patients by June 2022. The data collection will be completed in December 2023. Conclusions: To our knowledge, this trial will be among the first to evaluate the effectiveness, safety, and cost-effectiveness of remote digital monitoring and self-monitoring of patients with axial spondyloarthritis compared with usual care. Hence, the ReMonit study will contribute important knowledge to personalized follow-up strategies for patients with axial spondyloarthritis. These results may also be relevant for other patient groups with inflammatory joint diseases. Trial Registration: ClinicalTrials.gov NCT05031767; hpps://www.clinicaltrials.gov/study/NCT05031767 International Registered Report Identifier (IRRID): DERR1-10.2196/52872 %M 38150310 %R 10.2196/52872 %U https://www.researchprotocols.org/2023/1/e52872 %U https://doi.org/10.2196/52872 %U http://www.ncbi.nlm.nih.gov/pubmed/38150310 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e43882 %T Feasibility, Adherence, and Effectiveness of Blended Psychotherapy for Severe Mental Illnesses: Scoping Review %A Ehrt-Schäfer,Yamina %A Rusmir,Milan %A Vetter,Johannes %A Seifritz,Erich %A Müller,Mario %A Kleim,Birgit %+ Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Lenggstrasse 31, Zurich, 8032, Switzerland, 41 +41583842817, yamina.ehrt@pukzh.ch %K blended psychotherapy %K severe mental illnesses %K digital health intervention %K e-mental health %K scoping review %D 2023 %7 26.12.2023 %9 Review %J JMIR Ment Health %G English %X Background: Blended psychotherapy (bPT) combines face-to-face psychotherapy with digital interventions to enhance the effectiveness of mental health treatment. The feasibility and effectiveness of bPT have been demonstrated for various mental health issues, although primarily for patients with higher levels of functioning. Objective: This scoping review aims to investigate the feasibility, adherence, and effectiveness of bPT for the treatment of patients with severe mental illnesses (SMIs). Methods: Following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines, we conducted searches in PubMed, MEDLINE, Embase, PsycINFO, and PsycArticles for studies published until March 23, 2023. Results: Out of 587 screened papers, we incorporated 25 studies encompassing 23 bPT interventions, involving a total of 2554 patients with SMI. The intervention formats and research designs exhibited significant variation. Our findings offer preliminary evidence supporting the feasibility of bPT for SMI, although there is limited research on adherence. Nevertheless, the summarized studies indicated promising attrition rates, spanning from 0% to 37%, implying a potential beneficial impact of bPT on adherence to SMI treatment. The quantity of evidence on the effects of bPT for SMI was limited and challenging to generalize. Among the 15 controlled trials, 4 concluded that bPT interventions were effective compared with controls. However, it is noteworthy that 2 of these studies used the same study population, and the control groups exhibited significant variations. Conclusions: Overall, our review suggests that while bPT appears promising as a treatment method, further research is necessary to establish its effectiveness for SMI. We discuss considerations for clinical implementation, directions, and future research. %M 38147373 %R 10.2196/43882 %U https://mental.jmir.org/2023/1/e43882 %U https://doi.org/10.2196/43882 %U http://www.ncbi.nlm.nih.gov/pubmed/38147373 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e53935 %T Teaching Adolescents With Type 1 Diabetes Self-Compassion (TADS) to Reduce Diabetes Distress: Protocol for a Randomized Controlled Trial %A Dover,Saunya %A Ahmet,Alexandra %A Bluth,Karen %A Feldman,Brian M %A Goldbloom,Ellen B %A Goldfield,Gary S %A Hamilton,Sarah %A Imran,Omar %A Khalif,Adam %A Khatchadourian,Karine %A Lawrence,Sarah %A Leonard,Andrew %A Liu,Kuan %A Ouyang,Yongdong %A Peeters,Corien %A Shah,Jai %A Spector,Noah %A Zuijdwijk,Caroline %A Robinson,Marie-Eve %+ Children's Hospital of Eastern Ontario Research Institute, 401 Smyth Road, Ottawa, ON, K1H8L1, Canada, 1 6137377600, mrobinson@cheo.on.ca %K anxiety %K depression %K diabetes distress %K disordered eating %K mental health %K mindful self-compassion %K pediatrics %K randomized controlled trial %K type 1 diabetes %D 2023 %7 26.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adolescents living with type 1 diabetes (T1D) often experience diabetes distress (DD), a construct distinct from depression or anxiety that refers to the negative emotions that arise from living with and managing diabetes. Self-compassion, which involves being open to one’s own suffering and treating oneself with the same care one would show to loved ones, is associated with better psychological and clinical outcomes among individuals with T1D. Self-compassion is a skill that can be taught and therefore represents an opportunity for intervention. Objective: The overall aim of this study is to assess the effectiveness of a web-based mindful self-compassion for teens (MSC-T) intervention on improving DD, anxiety, depression, diabetes-related disordered eating, and suicidal ideation experienced by youth with T1D (aged between 12 and 17 years) compared with a waitlist control group (standard of care). We will also explore (1) if the effect of the MSC-T intervention changes over time, (2) if the MSC-T intervention has a positive impact on measures of glycemic control, and (3) if the effect of the MSC-T intervention differs based on self-reported gender. Methods: We will conduct a single-center, parallel-group randomized controlled trial of 140 adolescents with T1D followed for 12 months. Participants will be randomly allocated (using hidden allocation) in a 1:1 ratio to either the MSC-T intervention or the waitlist control group. Our primary outcome is DD, as measured by the Problem Areas in Diabetes-Teen (PAID-T) version at 3 months. Secondary outcomes, assessed at 3 and 12 months, include anxiety (Generalized Anxiety Disorder 7-item [GAD-7] scale), depression (Patient Health Questionnaire-9 [PHQ-9]), diabetes-related disordered eating (Diabetes Eating Problem Survey-Revised [DEPS-R] version), and suicidal ideation (using 1 question from the PHQ-9). Results: Study recruitment began in October 2022 and was completed in March 2023, with a total of 141 participants enrolling. Data collection will be ongoing until March 2024. The first results are expected in June 2024. Conclusions: This study will be the first randomized trial to assess the effectiveness of the web-based MSC-T intervention on adolescents with T1D. Given that adolescence is a period where individuals are typically required to assume more responsibility for their diabetes care, providing adolescents with the tools they need to better manage the stress that often accompanies T1D management is paramount. Trial Registration: ClinicalTrials.gov NCT05463874; https://clinicaltrials.gov/study/NCT05463874 International Registered Report Identifier (IRRID): DERR1-10.2196/53935 %M 38048480 %R 10.2196/53935 %U https://www.researchprotocols.org/2023/1/e53935 %U https://doi.org/10.2196/53935 %U http://www.ncbi.nlm.nih.gov/pubmed/38048480 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e51102 %T Efficacy of an Electronic Cognitive Behavioral Therapy Program Delivered via the Online Psychotherapy Tool for Depression and Anxiety Related to the COVID-19 Pandemic: Pre-Post Pilot Study %A Moghimi,Elnaz %A Stephenson,Callum %A Agarwal,Anika %A Nikjoo,Niloofar %A Malakouti,Niloufar %A Layzell,Gina %A O'Riordan,Anne %A Jagayat,Jasleen %A Shirazi,Amirhossein %A Gutierrez,Gilmar %A Khan,Ferwa %A Patel,Charmy %A Yang,Megan %A Omrani,Mohsen %A Alavi,Nazanin %+ Department of Psychiatry, Faculty of Health Sciences, Queen's University, 166 Brock Street, Kingston, ON, K7L 5G23, Canada, 1 6135443310, nazanin.alavitabari@kingstonhsc.ca %K mental health %K depression %K anxiety %K cognitive behavioral therapy %K online %K COVID-19 %K efficacy %K electronic cognitive behavioral therapy %K online psychotherapy tool %K pandemic %K evidence-based treatment %D 2023 %7 25.12.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Lockdowns and social distancing resulting from the COVID-19 pandemic have worsened the population’s mental health and made it more difficult for individuals to receive care. Electronic cognitive behavioral therapy (e-CBT) is a cost-effective and evidence-based treatment for anxiety and depression and can be accessed remotely. Objective: The objective of the study was to investigate the efficacy of online psychotherapy tailored to depression and anxiety symptoms during the pandemic. Methods: The pilot study used a pre-post design to evaluate the efficacy of a 9-week e-CBT program designed for individuals with depression and anxiety affected by the pandemic. Participants were adults (N=59) diagnosed with major depressive disorder and generalized anxiety disorder, whose mental health symptoms initiated or worsened during the COVID-19 pandemic. The online psychotherapy program focused on teaching coping, mindfulness, and problem-solving skills. Symptoms of anxiety and depression, resilience, and quality of life were assessed. Results: Participants demonstrated significant improvements in symptoms of anxiety (P=.02) and depression (P=.03) after the intervention. Similar trends were observed in the intention-to-treat analysis. No significant differences were observed in resilience and quality-of-life measures. The sample comprised mostly females, making it challenging to discern the benefits of the intervention in males. Although a pre-post design is less rigorous than a controlled trial, this design was selected to observe changes in scores during a critical period. Conclusions: e-CBT for COVID-19 is an effective and accessible treatment option. Improvements in clinical symptoms of anxiety and depression can be observed in individuals whose mental health is affected by the COVID-19 pandemic. Trial Registration: ClinicalTrials.gov NCT04476667; https://clinicaltrials.gov/study/NCT04476667 International Registered Report Identifier (IRRID): RR2-10.2196/24913 %M 37993984 %R 10.2196/51102 %U https://mental.jmir.org/2023/1/e51102 %U https://doi.org/10.2196/51102 %U http://www.ncbi.nlm.nih.gov/pubmed/37993984 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e53933 %T Evaluating the Impact of an App-Delivered Mindfulness Meditation Program to Reduce Stress and Anxiety During Pregnancy: Pilot Longitudinal Study %A Balsam,Donna %A Bounds,Dawn T %A Rahmani,Amir M %A Nyamathi,Adeline %+ School of Nursing, San Diego State University, 5500 Campanile Mall, San Diego, CA, 92182, United States, 1 6195942540, dbalsam@sdsu.edu %K mindfulness app %K pregnancy %K pregnant %K maternal %K obstetric %K obstetrics %K stress %K anxiety %K heart rate variability %K mindfulness %K mHealth %K mobile health %K app %K apps %K applications %K mental health %K meditation %K mind-body %K complementary %K alternative %K heart rate %K sleep %K mobile phone %D 2023 %7 25.12.2023 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Stress and anxiety during pregnancy are extremely prevalent and are associated with numerous poor outcomes, among the most serious of which are increased rates of preterm birth and low birth weight infants. Research supports that while in-person mindfulness training is effective in reducing pregnancy stress and anxiety, there are barriers limiting accessibility. Objective: The aim of this paper is to determine if mindfulness meditation training with the Headspace app is effective for stress and anxiety reduction during pregnancy. Methods: A longitudinal, single-arm trial was implemented with 20 pregnant women who were instructed to practice meditation via the Headspace app twice per day during the month-long trial. Validated scales were used to measure participant’s levels of stress and anxiety pre- and postintervention. Physiological measures reflective of stress (heart rate variability and sleep) were collected via the Oura Ring. Results: Statistically significant reductions were found in self-reported levels of stress (P=.005), anxiety (P=.01), and pregnancy anxiety (P<.0001). Hierarchical linear modeling revealed a statistically significant reduction in the physiological data reflective of stress in 1 of 6 heart rate variability metrics, the low-frequency power band, which decreased by 13% (P=.006). A total of 65% of study participants (n=13) reported their sleep improved during the trial, and 95% (n=19) stated that learning mindfulness helped with other aspects of their lives. Participant retention was 100%, with 65% of participants (n=13) completing about two-thirds of the intervention, and 50% of participants (n=10) completing ≥95%. Conclusions: This study found evidence to support the Headspace app as an effective intervention to aid in stress and anxiety reduction during pregnancy. %M 38145479 %R 10.2196/53933 %U https://pediatrics.jmir.org/2023/1/e53933 %U https://doi.org/10.2196/53933 %U http://www.ncbi.nlm.nih.gov/pubmed/38145479 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46579 %T Exploring Counselor Practices and Risk Assessment in a Proactive Digital Intervention Through Instagram in Young People: Qualitative Study %A Peart,Natalie %A Hetrick,Sarah %A Gibson,Kerry %A Stasiak,Karolina %+ Department of Psychology, University of Auckland, 23 Symonds Street, Auckland, 1023, New Zealand, 64 276758552, nnatalie.peart@auckland.ac.nz %K counseling %K distress %K empathize %K internet %K mental health %K online text %K proactive %K qualitative study %K risk assessment %K self-harm %K social media %K suicide %K validation %K youth %D 2023 %7 25.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Suicide is one of the leading causes of preventable death in young people, and the way young people are communicating suicidality has evolved to include web-based disclosures and help-seeking. To date, mental health intervention services, both on the web and in person, have been conceived in the traditional model, whereby support is provided if a young person (or their family) actively seeks out that support when distressed. On the other hand, proactive outreach is an innovative approach to intervention that has been shown to be effective in other areas of health care. Live for Tomorrow chat was delivered on Instagram and comprised of counselors who reach out to provide brief person-centered intervention to young people who post content indicating distress or suicidality. Objective: Our aim was to explore how counselors engaged young people in a proactive digital intervention and how risk assessment was conducted in this context. Methods: We analyzed 35 transcripts of conversations between counselors and young people aged 13-25 years using the 6-step approach of Braun and Clarke’s reflexive thematic analysis. These transcripts included a counseling intervention and a follow-up chat that was aimed at collecting feedback about the counseling intervention. Results: A total of 7 themes emerged: using microskills to facilitate conversations, building confidence and capacity to cope with change, seeking permission when approaching conversations about suicidality or self-harm, conversations about suicidality following a structured approach, providing assurances of confidentiality, validation of the experience of suicidality, and using conversations about suicidality to identify interventions. Counselors were able to translate counseling microskills and structured questioning regarding suicidality into a digital context. In particular, in the digital context, counselors would use the young person’s post and emojis to further conversations and build rapport. Conclusions: The findings highlight the importance of the counselor’s role to listen, empathize, validate, and empower young people and that all these skills can be transferred to a digital text counseling intervention. Counselors used a structured approach to understanding suicidality in a permission-seeking, validating, and confidential manner to identify interventions with the young person. These practices allowed the conversation to move beyond traditional risk assessment practices to meaningful conversations about suicidality. Moving beyond traditional risk assessment practices and into conversations about suicidality allowed for the validation of the young person’s experience and exploration of interventions and support that made sense and were seen to be helpful to the young person. This study highlighted the benefits of a proactive digital chat-based intervention, which is a novel approach to engaging with young people experiencing psychological distress and suicidality. Furthermore, this research demonstrates the feasibility and benefit of moving mental health intervention and support to a medium where young people are currently disclosing distress and intervening proactively. %M 38145477 %R 10.2196/46579 %U https://formative.jmir.org/2023/1/e46579 %U https://doi.org/10.2196/46579 %U http://www.ncbi.nlm.nih.gov/pubmed/38145477 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e50550 %T Supportive Digital Health Service During Cancer Chemotherapy: Single-Arm Before-and-After Feasibility Study %A Fridriksdottir,Nanna %A Ingadottir,Brynja %A Skuladottir,Kristin %A Zoëga,Sigridur %A Gunnarsdottir,Sigridur %+ Landspitali- The National University Hospital of Iceland, Hringbraut, Reykjavik, 101, Iceland, 354 543 1000 ext 6065, nannafri@landspitali.is %K web portal for patients with cancer %K supportive digital health service %K symptom monitoring %K self-management support %K feasibility %K usability %K acceptability %K patient education %K health engagement %K patient-reported outcomes %K digital health service %K patient portal %K electronic health records %K mobile phone %D 2023 %7 22.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital supportive cancer care is recommended to improve patient outcomes. A portal was designed and embedded within the electronic medical record and public health portal of Iceland, consisting of symptom and needs monitoring, educational material, and messaging. Objective: This study aims to assess (1) portal feasibility (adoption, engagement, usability, and acceptability), (2) potential predictors of usability and acceptability, and (3) the potential impact of the portal on patient-reported outcomes. Methods: This was a single-arm, before-and-after feasibility study at a university hospital among patients with cancer who were undergoing chemotherapy. Participation included filling out the Edmonton Symptom Assessment System–Revised (ESASr) weekly and the Distress Thermometer and Problem List (DT&PL) 3 times; reading educational material and messaging; and completing study questionnaires. Clinical and portal engagement data were collected from medical records. Data from patients were collected electronically at baseline and 7 to 10 days after the third chemotherapy round. Usability was assessed using the System Usability Scale (score 0-100), and acceptability was assessed using a 35-item survey (score 1-5). Patient-reported outcome measures included ESASr and DT&PL; a single-item scale for quality of life, family support, and quality of care; and multi-item scales for health literacy (Brief Health Literacy Screener), health engagement (Patient Health Engagement Scale), self-care self-efficacy (Self-Care Self-Efficacy scale), symptom interference (MD Anderson Symptom Inventory), knowledge expectations (Hospital Patients’ Knowledge Expectations), and received knowledge (Hospital Patients’ Received Knowledge). Health care professionals were interviewed regarding portal feasibility. Results: The portal adoption rate was 72% (103/143), and the portal use rate was 76.7% (79/103) over a mean 8.6 (SD 2.7) weeks. The study completion rate was 67% (69/103). The combined completion rate of the ESASr and DT&PL was 78.4% (685/874). Patients received a mean 41 (SD 13) information leaflets; 33% (26/79) initiated messaging, 73% (58/79) received messages, and 85% (67/79) received follow-up phone calls. The mean System Usability Scale score was 72.3 (SD 14.7), indicating good usability. Usability was predicted by age (β=−.45), ESASr engagement (β=.5), symptom interference (β=.4), and received knowledge (β=.41). The mean acceptability score, 3.97 (SD 0.5), was above average and predicted by age (β=−.31), ESASr engagement (β=.37), symptom interference (β=.60), self-care self-efficacy (β=.37), and received knowledge (β=.41). ESASr scores improved for total symptom distress (P=.003; Cohen d=0.36), physical symptoms (P=.01; Cohen d=0.31), and emotional symptoms (P=.01; Cohen d=0.31). Daily symptom interference increased (P=.03; Cohen d=0.28), quality of life improved (P=.03; Cohen d=0.27) and health engagement (P=.006; Cohen d=0.35) improved, while knowledge expectations decreased (P≤.001; Cohen d=2.57). Health care professionals were positive toward the portal but called for clearer role delineation and follow-up. Conclusions: This study supports the feasibility of a support portal and the results indicate the possibility of improving patient outcomes, but further developments are warranted. %M 38015268 %R 10.2196/50550 %U https://formative.jmir.org/2023/1/e50550 %U https://doi.org/10.2196/50550 %U http://www.ncbi.nlm.nih.gov/pubmed/38015268 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e48958 %T Developing Mood-Based Computer-Tailored Health Communication for Smoking Cessation: Feasibility Randomized Controlled Trial %A Lee,Donghee N %A Sadasivam,Rajani S %A Stevens,Elise M %+ Department of Population and Quantitative Health Sciences, Division of Preventive and Behavioral Medicine, UMass Chan Medical School, 368 Plantation St, Worcester, MA, 01605, United States, 1 774 455 4871, donghee.lee10@umassmed.edu %K mood %K smoking cessation messages %K computer-tailored health communication %K innovation %K smoking %K cessation %K digital intervention %K effectiveness %K text mining %K adult %K motivation %D 2023 %7 22.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Computer-tailored health communication (CTHC), a widely used strategy to increase the effectiveness of smoking cessation interventions, is focused on selecting the best messages for an individual. More recently, CTHC interventions have been tested using contextual information such as participants’ current stress or location to adapt message selection. However, mood has not yet been used in CTCH interventions and may increase their effectiveness. Objective: This study aims to examine the association of mood and smoking cessation message effectiveness among adults who currently smoke cigarettes. Methods: In January 2022, we recruited a web-based convenience sample of adults who smoke cigarettes (N=615; mean age 41.13 y). Participants were randomized to 1 of 3 mood conditions (positive, negative, or neutral) and viewed pictures selected from the International Affective Picture System to induce an emotional state within the assigned condition. Participants then viewed smoking cessation messages with topics covering five themes: (1) financial costs or rewards, (2) health, (3) quality of life, (4) challenges of quitting, and (5) motivation or reasons to quit. Following each message, participants completed questions on 3 constructs: message receptivity, perceived relevance, and their motivation to quit. The process was repeated 30 times. We used 1-way ANOVA to estimate the association of the mood condition on these constructs, controlling for demographics, cigarettes per day, and motivation to quit measured during the pretest. We also estimated the association between mood and outcomes for each of the 5 smoking message theme categories. Results: There was an overall statistically significant effect of the mood condition on the motivation to quit outcome (P=.02) but not on the message receptivity (P=.16) and perceived relevance (P=.86) outcomes. Participants in the positive mood condition reported significantly greater motivation to quit compared with those in the negative mood condition (P=.005). Participants in the positive mood condition reported higher motivation to quit after viewing smoking cessation messages in the financial (P=.03), health (P=.01), quality of life (P=.04), and challenges of quitting (P=.03) theme categories. We also compared each mood condition and found that participants in the positive mood condition reported significantly greater motivation to quit after seeing messages in the financial (P=.01), health (P=.003), quality of life (P=.01), and challenges of quitting (P=.01) theme categories than those in the negative mood condition. Conclusions: Our findings suggest that considering mood may be important for future CTHC interventions. Because those in the positive mood state at the time of message exposure were more likely to have greater quitting motivations, smoking cessation CTHC interventions may consider strategies to help improve participants’ mood when delivering these messages. For those in neutral and negative mood states, focusing on certain message themes (health and motivation to quit) may be more effective than other message themes. %M 38133916 %R 10.2196/48958 %U https://formative.jmir.org/2023/1/e48958 %U https://doi.org/10.2196/48958 %U http://www.ncbi.nlm.nih.gov/pubmed/38133916 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e51471 %T Effects of Internal and External Factors on Hospital Data Breaches: Quantitative Study %A Dolezel,Diane %A Beauvais,Brad %A Stigler Granados,Paula %A Fulton,Lawrence %A Kruse,Clemens Scott %+ Health Informatics & Information Management Department, Texas State University, 100 Bobcat Way, Round Rock, TX, 78665, United States, 1 512 716 2840, dd30@txstate.edu %K data breach %K security %K geospatial %K predictive %K mobile phone %D 2023 %7 21.12.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Health care data breaches are the most rapidly increasing type of cybercrime; however, the predictors of health care data breaches are uncertain. Objective: This quantitative study aims to develop a predictive model to explain the number of hospital data breaches at the county level. Methods: This study evaluated data consolidated at the county level from 1032 short-term acute care hospitals. We considered the association between data breach occurrence (a dichotomous variable), predictors based on county demographics, and socioeconomics, average hospital workload, facility type, and average performance on several hospital financial metrics using 3 model types: logistic regression, perceptron, and support vector machine. Results: The model coefficient performance metrics indicated convergent validity across the 3 model types for all variables except bad debt and the factor level accounting for counties with >20% and up to 40% Hispanic populations, both of which had mixed coefficient directionality. The support vector machine model performed the classification task best based on all metrics (accuracy, precision, recall, F1-score). All the 3 models performed the classification task well with directional congruence of weights. From the logistic regression model, the top 5 odds ratios (indicating a higher risk of breach) included inpatient workload, medical center status, pediatric trauma center status, accounts receivable, and the number of outpatient visits, in high to low order. The bottom 5 odds ratios (indicating the lowest odds of experiencing a data breach) occurred for counties with Black populations of >20% and <40%, >80% and <100%, and >40% but <60%, as well as counties with ≤20% Asian or between 80% and 100% Hispanic individuals. Our results are in line with those of other studies that determined that patient workload, facility type, and financial outcomes were associated with the likelihood of health care data breach occurrence. Conclusions: The results of this study provide a predictive model for health care data breaches that may guide health care managers to reduce the risk of data breaches by raising awareness of the risk factors. %M 38127426 %R 10.2196/51471 %U https://www.jmir.org/2023/1/e51471 %U https://doi.org/10.2196/51471 %U http://www.ncbi.nlm.nih.gov/pubmed/38127426 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e47987 %T The Effectiveness of Strategies to Improve User Engagement With Digital Health Interventions Targeting Nutrition, Physical Activity, and Overweight and Obesity: Systematic Review and Meta-Analysis %A Grady,Alice %A Pearson,Nicole %A Lamont,Hannah %A Leigh,Lucy %A Wolfenden,Luke %A Barnes,Courtney %A Wyse,Rebecca %A Finch,Meghan %A Mclaughlin,Matthew %A Delaney,Tessa %A Sutherland,Rachel %A Hodder,Rebecca %A Yoong,Sze Lin %+ School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, 2308, Australia, 61 (02) 4924 6499, alice.grady@newcastle.edu.au %K engagement %K digital health interventions %K systematic review %K nutrition %K physical activity %K obesity %D 2023 %7 19.12.2023 %9 Review %J J Med Internet Res %G English %X Background: Digital health interventions (DHIs) are effective in improving poor nutrition, physical inactivity, overweight and obesity. There is evidence suggesting that the impact of DHIs may be enhanced by improving user engagement. However, little is known about the overall effectiveness of strategies on engagement with DHIs. Objective: This study aims to assess the overall effectiveness of strategies to improve engagement with DHIs targeting nutrition, physical activity, and overweight or obesity and explore associations between strategies and engagement outcomes. The secondary aim was to explore the impact of these strategies on health risk outcomes. Methods: The MEDLINE, Embase, PsycINFO, CINAHL, CENTRAL, Scopus, and Academic Source Complete databases were searched up to July 24, 2023. Eligible studies were randomized controlled trials that evaluated strategies to improve engagement with DHIs and reported on outcomes related to DHI engagement (use or user experience). Strategies were classified according to behavior change techniques (BCTs) and design features (eg, supplementary emails). Multiple-variable meta-analyses of the primary outcomes (usage and user experience) were undertaken to assess the overall effectiveness of strategies. Meta-regressions were conducted to assess associations between strategies and use and user experience outcomes. Synthesis of secondary outcomes followed the “Synthesis Without Meta-Analysis” guidelines. The methodological quality and evidence was assessed using the Cochrane risk-of-bias tool, and the Grading of Recommendations Assessment, Development, and Evaluation tool respectively. Results: Overall, 54 studies (across 62 publications) were included. Pooled analysis found very low-certainty evidence of a small-to-moderate positive effect of the use of strategies to improve DHI use (standardized mean difference=0.33, 95% CI 0.20-0.46; P<.001) and very low-certainty evidence of a small-to-moderate positive effect on user experience (standardized mean difference=0.29, 95% CI 0.07-0.52; P=.01). A significant positive association was found between the BCTs social support (effect size [ES]=0.40, 95% CI 0.14-0.66; P<.001) and shaping knowledge (ES=0.39, 95% CI 0.03-0.74; P=.03) and DHI use. A significant positive association was found among the BCTs social support (ES=0.70, 95% CI 0.18-1.22; P=.01), repetition and substitution (ES=0.29, 95% CI 0.05-0.53; P=.03), and natural consequences (ES=0.29, 95% CI 0.05-0.53; P=.02); the design features email (ES=0.29, 95% CI 0.05-0.53; P=.02) and SMS text messages (ES=0.34, 95% CI 0.11-0.57; P=.01); and DHI user experience. For secondary outcomes, 47% (7/15) of nutrition-related, 73% (24/33) of physical activity–related, and 41% (14/34) of overweight- and obesity-related outcomes reported an improvement in health outcomes. Conclusions: Although findings suggest that the use of strategies may improve engagement with DHIs targeting such health outcomes, the true effect is unknown because of the low quality of evidence. Future research exploring whether specific forms of social support, repetition and substitution, natural consequences, emails, and SMS text messages have a greater impact on DHI engagement is warranted. Trial Registration: PROSPERO CRD42018077333; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=77333 %M 38113062 %R 10.2196/47987 %U https://www.jmir.org/2023/1/e47987 %U https://doi.org/10.2196/47987 %U http://www.ncbi.nlm.nih.gov/pubmed/38113062 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44610 %T Evaluation of the Needs and Experiences of Patients with Hypertriglyceridemia: Social Media Listening Infosurveillance Study %A Song,Junxian %A Cui,Yuxia %A Song,Jing %A Lee,Chongyou %A Wu,Manyan %A Chen,Hong %+ Beijing Key Laboratory of Early Prediction and Intervention of Acute Myocardial Infarction, Department of Cardiology, Center for Cardiovascular Translational Research, Peking University People’s Hospital, No 11 Xizhimen South Road, Xicheng district, Beijing, 100044, China, 86 10 88325940, chenhongbj@medmail.com.cn %K social media listening %K hypertriglyceridemia %K infosurveillance study %K disease cognition %K lifestyle intervention %K lipid disorder %K awareness %K online search %K telemedicine %K self-medication %K Chinese medicine %K natural language processing %K cardiovascular disease %K stroke %K online platform %K self-management %K Q&A search platform %K social media %D 2023 %7 19.12.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Hypertriglyceridemia is a risk factor for cardiovascular diseases. Internet usage in China is increasing, giving rise to large-scale data sources, especially to access, disseminate, and discuss medical information. Social media listening (SML) is a new approach to analyze and monitor online discussions related to various health-related topics in diverse diseases, which can generate insights into users’ experiences and expectations. However, to date, no studies have evaluated the utility of SML to understand patients’ cognizance and expectations pertaining to the management of hypertriglyceridemia. Objective: The aim of this study was to utilize SML to explore the disease cognition level of patients with hypertriglyceridemia, choice of intervention measures, and the status quo of online consultations and question-and-answer (Q&A) search platforms. Methods: An infosurveillance study was conducted wherein a disease-specific comprehensive search was performed between 2004 and 2020 in Q&A search and online consultation platforms. Predefined single and combined keywords related to hypertriglyceridemia were used in the search, including disease, symptoms, diagnosis, and treatment indicators; lifestyle interventions; and therapeutic agents. The search output was aggregated using an aggregator tool and evaluated. Results: Disease-specific consultation data (n=69,845) and corresponding response data (n=111,763) were analyzed from 20 data sources (6 Q&A search platforms and 14 online consultation platforms). Doctors from inland areas had relatively high voice volumes and appear to exert a substantial influence on these platforms. Patients with hypertriglyceridemia engaging on the internet have an average level of cognition about the disease and its intervention measures. However, a strong demand for the concept of the disease and “how to treat it” was observed. More emphasis on the persistence of the disease and the safety of medications was observed. Young patients have a lower willingness for drug interventions, whereas patients with severe hypertriglyceridemia have a clearer intention to use drug intervention and few patients have a strong willingness for the use of traditional Chinese medicine. Conclusions: Findings from this disease-specific SML study revealed that patients with hypertriglyceridemia in China actively seek information from both online Q&A search and consultation platforms. However, the integrity of internet doctors’ suggestions on lifestyle interventions and the accuracy of drug intervention recommendations still need to be improved. Further, a combined prospective qualitative study with SML is required for added rigor and confirmation of the relevance of the findings. %M 38113100 %R 10.2196/44610 %U https://www.jmir.org/2023/1/e44610 %U https://doi.org/10.2196/44610 %U http://www.ncbi.nlm.nih.gov/pubmed/38113100 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43809 %T Efficacy of an mHealth App to Support Patients’ Self-Management of Hypertension: Randomized Controlled Trial %A Liu,Fang %A Song,Ting %A Yu,Ping %A Deng,Ning %A Guan,Yingping %A Yang,Yang %A Ma,Yuanji %+ Department of Cardiology, Zhongshan Hospital, Fudan University, 1609 Xietu Road, Shanghai, 200031, China, 86 21 64041990, myj-215@163.com %K mobile app %K mHealth %K mobile health %K smartphone %K high blood pressure %K medication adherence %K reminder %K health education %K motivation %K hypertension control %K hypertension %K blood pressure %K self-management %D 2023 %7 19.12.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Hypertension is a significant global disease burden. Mobile health (mHealth) offers a promising means to provide patients with hypertension with easy access to health care services. Yet, its efficacy needs to be validated, especially in lower-income areas with a high-salt diet. Objective: This study aims to assess the efficacy of an mHealth app–based intervention in supporting patients’ self-management of hypertension. Methods: A 2-arm randomized controlled trial was conducted among 297 patients with hypertension at the General Hospital of Ningxia Medical University, Ningxia Hui Autonomous Region, China. Participants selected via convenience sampling were randomly allocated into intervention and control groups. Intervention group participants were trained and asked to use an mHealth app named Blood Pressure Assistant for 6 months. They could use the app to record and upload vital signs, access educational materials, and receive self-management reminders and feedback from health care providers based on the analysis of the uploaded data. Control group participants received usual care. Blood pressure (BP) and 2 questionnaire surveys about hypertension knowledge and lifestyle behavior were used to assess all participants at baseline and 6 months. Data analysis was performed with SPSS software using 2-tailed t tests and a chi-square test. Results: There were no significant differences in baseline characteristics and medication use between the 2 groups (all P>.05). After 6 months, although both groups show a significant pre-post improvement (P<.001 each), the BP control rate (ie, the proportion of patients with a systolic BP of <140 mm Hg and diastolic BP of <90 mm Hg) in the intervention group was better than that in the control group (100/111, 90.1% vs 75/115, 65.2%; P<.001). The mean systolic and diastolic BP were significantly reduced by 25.83 (SD 8.99) and 14.28 (SD 3.74) mm Hg in the intervention group (P<.001) and by 21.83 (SD 6.86) and 8.87 (SD 4.22) mm Hg in the control group (P<.001), respectively. The differences in systolic and diastolic BP between the 2 groups were significant (P<.001 and P=.01, respectively). Hypertension knowledge significantly improved only in the intervention group in both pre-post and intergroup comparisons (both P<.001). However, only intragroup improvement was observed for lifestyle behaviors in the intervention group (P<.001), including medication adherence (P<.001), healthy diet (P=.02), low salt intake (P<.001), and physical exercises (P=.02), and no significant difference was observed in the control group or on intergroup comparisons. Conclusions: This research shows that the mHealth app–based intervention has the potential to improve patient health knowledge and support self-management among them toward a healthier lifestyle, including medication adherence, low-salt diets, and physical exercises, thereby achieving optimal BP control. Further research is still needed to verify the specific effects of these interventions. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900026437; https://www.chictr.org.cn/showproj.html?proj=38801 %M 38113071 %R 10.2196/43809 %U https://www.jmir.org/2023/1/e43809 %U https://doi.org/10.2196/43809 %U http://www.ncbi.nlm.nih.gov/pubmed/38113071 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42510 %T Comparing Web-Based and Blended Training for Coping With Challenges of Flexible Work Designs: Randomized Controlled Trial %A Althammer,Sarah Elena %A Wöhrmann,Anne Marit %A Michel,Alexandra %+ Federal Institute for Occupational Safety and Health, Friedrich-Henkel-Weg 1-25, Dortmund, 44149, Germany, 49 23190712071, sarah.althammer@alumni.uni-heidelberg.de %K blended training %K web-based training %K psychological detachment %K well-being %K work-life balance %D 2023 %7 19.12.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Workers with flexible work designs (FWDs) face specific challenges, such as difficulties in detaching from work, setting boundaries between work and private life, and recovering from work. Objective: This study evaluated the effectiveness of an intervention in improving the recovery, work-life balance, and well-being of workers with FWDs compared with a waitlist control group. It also compares the effectiveness of a web-based training format and blended training format. Methods: In the web-based training format, participants individually completed 6 web-based modules and daily tasks over 6 weeks, learning self-regulation strategies to meet the particular challenges of FWDs. In the blended training format, participants attended 3 group sessions in addition to completing the 6 web-based modules. In a randomized controlled trial, participants were assigned to a web-based intervention group (196/575, 34.1%), blended intervention group (198/575, 34.4%), or waitlist control group (181/575, 31.5%). Study participants self-assessed their levels of primary outcomes (psychological detachment, satisfaction with work-life balance, and well-being) before the intervention, after the intervention, at a 4-week follow-up, and at a 6-month follow-up. The final sample included 373 participants (web-based intervention group: n=107, 28.7%; blended intervention group: n=129, 34.6%; and control group: n=137, 36.7%). Compliance was assessed as a secondary outcome. Results: The results of multilevel analyses were in line with our hypothesis that both training formats would improve psychological detachment, satisfaction with work-life balance, and well-being. We expected blended training to reinforce these effects, but blended training participants did not profit more from the intervention than web-based training participants. However, they reported to have had more social exchange, and blended training participants were more likely to adhere to the training. Conclusions: Both web-based and blended training are effective tools for improving the recovery, work-life balance, and well-being of workers with FWDs. Group sessions can increase the likelihood of participants actively participating in web-based modules and exercises. Trial Registration: German Clinical Trials Register DRKS00032721; https://drks.de/search/en/trial/DRKS00032721 %M 38113084 %R 10.2196/42510 %U https://www.jmir.org/2023/1/e42510 %U https://doi.org/10.2196/42510 %U http://www.ncbi.nlm.nih.gov/pubmed/38113084 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 8 %N %P e49097 %T Barriers and Enablers to the Adoption of a Healthier Diet Using an App: Qualitative Interview Study With Patients With Type 2 Diabetes Mellitus %A Montilva-Monsalve,Jonas %A Dimantas,Bruna %A Perski,Olga %A Gutman,Leslie Morrison %+ Centre for Behaviour Change, Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London, WC1E 7HB, United Kingdom, 44 020 7679 2000, l.gutman@ucl.ac.uk %K behavior change techniques %K diabetes %K apps %K smartphone %K enablers %K barriers %K mobile phone %D 2023 %7 19.12.2023 %9 Original Paper %J JMIR Diabetes %G English %X Background: Adopting a healthy diet is one of the cornerstones of type 2 diabetes (T2D) management. Apps are increasingly used in diabetes self-management, but most studies to date have focused on assessing their impact in terms of weight loss or glycemic control, with limited evidence on the behavioral factors that influence app use to change dietary habits. Objective: The main objectives of this study were to assess the enablers and barriers to adopting a healthier diet using the Gro Health app in 2 patient groups with T2D (patients with recently diagnosed and long-standing T2D) and to identify behavior change techniques (BCTs) to enhance enablers and overcome barriers. Methods: Two semistructured qualitative interview studies were conducted; the first study took place between June and July 2021, with a sample of 8 patients with recently diagnosed (<12 mo) T2D, whereas the second study was conducted between May and June 2022 and included 15 patients with long-standing (>18 mo) T2D. In both studies, topic guides were informed by the Capability, Opportunity, Motivation, and Behavior model and the Theoretical Domains Framework. Transcripts were analyzed using a combined deductive framework and inductive thematic analysis approach. The Behavior Change Wheel framework was applied to identify appropriate BCTs that could be used in future iterations of apps for patients with diabetes. Themes were compared between the patient groups. Results: This study identified similarities and differences between patient groups in terms of enablers and barriers to adopting a healthier diet using the app. The main enablers for recently diagnosed patients included the acquired knowledge about T2D diets and skills to implement these, whereas the main barriers were the difficulty in deciding which app features to use and limited cooking skills. By contrast, for patients with long-standing T2D, the main enablers included knowledge validation provided by the app, along with app elements to help self-regulate food intake; the main barriers were the limited interest paid to the content provided or limited skills engaging with apps in general. Both groups reported more enablers than barriers to performing the target behavior when using the app. Consequently, BCTs were selected to address key barriers in both groups, such as simplifying the information hierarchy in the app interface, including tutorials demonstrating how to use the app features, and redesigning the landing page of the app to guide users toward these tutorials. Conclusions: Patients with recently diagnosed and long-standing T2D encountered similar enablers but slightly different barriers when using an app to adopting a healthier diet. Consequently, the development of app-based approaches to adopt a healthier diet should account for these similarities and differences within patient segments to reduce barriers to performing the target behavior. %M 38113087 %R 10.2196/49097 %U https://diabetes.jmir.org/2023/1/e49097 %U https://doi.org/10.2196/49097 %U http://www.ncbi.nlm.nih.gov/pubmed/38113087 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44762 %T Narrowing the Patient–Physician Gap Based on Self-Reporting and Monthly Hepatologist Feedback for Patients With Alcohol-Related Liver Disease: Interventional Pilot Study Using a Journaling Smartphone App %A Yamashiki,Noriyo %A Kawabata,Kyoko %A Murata,Miki %A Ikeda,Shunichiro %A Fujimaki,Takako %A Suwa,Kanehiko %A Seki,Toshihito %A Aramaki,Eiji %A Naganuma,Makoto %+ Department of Gastroenterology and Hepatology, Kansai Medical University Medical Center, Fumizono 10-15, Moriguchi, Osaka, 570-8507, Japan, 81 6 6992 1001, yamashno@takii.kmu.ac.jp %K alcohol-related liver disease %K alcohol use disorder %K alcoholism %K smartphone %K mobile health %D 2023 %7 19.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Screening and intervention for alcohol use disorders (AUDs) are recommended to improve the prognosis of patients with alcohol-related liver disease (ALD). Most patients’ smartphone app diaries record drinking behavior for self-monitoring. A smartphone app can be expected to also be helpful for physicians because it can provide rich patient information to hepatologists, leading to suitable feedback. We conducted this prospective pilot study to assess the use of a smartphone app as a journaling tool and as a self-report–based feedback source for patients with ALD. Objective: The aims of this study were assessment of whether journaling (self-report) and self-report–based feedback can help patients maintain abstinence and improve liver function data. Methods: This pilot study used a newly developed smartphone journaling app for patients, with input data that physicians can review. After patients with ALD were screened for harmful alcohol use, some were invited to use the smartphone journaling app for 8 weeks. Their self-reported alcohol intake, symptoms, and laboratory data were recorded at entry, week 4, and week 8. Biomarkers for alcohol use included gamma glutamyl transferase (GGT), percentage of carbohydrate-deficient transferrin to transferrin (%CDT), and GGT-CDT (GGT-CDT= 0.8 × ln[GGT] + 1.3 × ln[%CDT]). At each visit, their recorded data were reviewed by a hepatologist to evaluate changes in alcohol consumption and laboratory data. The relation between those outcomes and app usage was also investigated. Results: Of 14 patients agreeing to participate, 10 completed an 8-week follow-up, with diary input rates between 44% and 100% of the expected days. Of the 14 patients, 2 withdrew from clinical follow-up, and 2 additional patients never used the smartphone journaling app. Using the physician’s view, a treating hepatologist gave feedback via comments to patients at each visit. Mean self-reported alcohol consumption dropped from baseline (100, SD 70 g) to week 4 (13, SD 25 g; P=.002) and remained lower at week 8 (13, SD 23 g; P=.007). During the study, 5 patients reported complete abstinence. No significant changes were found in mean GGT and mean %CDT alone, but the mean GGT-CDT combination dropped significantly from entry (5.2, SD 1.2) to the week 4 visit (4.8, SD 1.1; P=.02) and at week 8 (4.8, SD 1.0; P=.01). During the study period, decreases in mean total bilirubin (3.0, SD 2.4 mg/dL to 2.4, SD 1.9 mg/dL; P=.01) and increases in mean serum albumin (3.0, SD 0.9 g/dL to 3.3, SD 0.8 g/dL; P=.009) were recorded. Conclusions: These pilot study findings revealed that a short-term intervention with a smartphone journaling app used by both patients and treatment-administering hepatologists was associated with reduced drinking and improved liver function. Trial Registration: UMIN CTR UMIN000045285; http://tinyurl.com/yvvk38tj %R 10.2196/44762 %U https://formative.jmir.org/2023/1/e44762/ %U https://doi.org/10.2196/44762 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e51531 %T Digital Therapeutic Intervention for Women in the UK Armed Forces Who Consume Alcohol at a Hazardous or Harmful Level: Protocol for a Randomized Controlled Trial %A Williamson,Grace %A Carr,Ewan %A Fear,Nicola T %A Dymond,Simon %A King,Kate %A Simms,Amos %A Goodwin,Laura %A Murphy,Dominic %A Leightley,Daniel %+ King's Centre for Military Health Research, King's College London, Strand, London, SE5 9RJ, United Kingdom, 44 (0)20 7123 4843, daniel.leightley@kcl.ac.uk %K mental health %K digital health %K DrinksRation %K women %K woman %K United Kingdom %K Armed Forces %K alcohol %K randomized controlled trial %K RCT %K controlled trials %K study protocol %K alcohol misuse %K smartphone app %K mobile app %K mobile health %K mHealth %K veterans %K women veterans %K mobile phone %K digital therapeutic %D 2023 %7 19.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Alcohol misuse is common in the United Kingdom Armed Forces (UKAF), with prevalence significantly higher than in the general population. To date, digital health initiatives to support alcohol misuse have focused on male individuals, who represent approximately 89% of the UKAF. However, female veterans drink disproportionally more than female members of the public. Objective: This 2-arm participant-blinded (single-blinded) confirmatory randomized controlled trial (RCT) aims to assess the efficacy of a brief alcohol intervention (DrinksRation) in reducing weekly self-reported alcohol consumption between baseline and a 3-month follow-up (day 84) among women who have served in the UKAF. Methods: In this 2-arm single-blinded RCT, a smartphone app that includes interactive user-focused features tailored toward the needs of female veterans and designed to enhance participants’ motivations to reduce the amount of alcohol they consume is compared with the UK Chief Medical Officer guidance on alcohol consumption. The trial will be conducted among women who have served at least 1 day of paid service in the UKAF. Recruitment, consent, and data collection will be carried out automatically through the DrinksRation app or the BeAlcoholSmart platform. The primary outcome is change in self-reported weekly alcohol consumption between baseline (day 0) and the 3-month follow-up (day 84) measured using the Timeline Follow Back for alcohol consumption. The secondary outcome is the change in the Alcohol Use Disorders Identification Test score measured at baseline and 3-month follow-up between the control and intervention groups. The process evaluation measures include (1) app use and (2) usability ratings as measured by the mHealth App Usability Questionnaire. Results: RCT recruitment will begin in January 2024 and last for 5 months. We aim to complete all data collection, including interviews, by May 2024. Conclusions: This study will assess whether a smartphone app tailored to the needs of women who have served in the UKAF is efficacious in reducing self-reported alcohol consumption. If successful, the digital therapeutics platform could be used not only to support women who have served in the UKAF but also for other conditions and disorders. Trial Registration: ClinicalTrials.gov NCT05970484; https://www.clinicaltrials.gov/study/NCT05970484 International Registered Report Identifier (IRRID): PRR1-10.2196/51531 %M 38113103 %R 10.2196/51531 %U https://www.researchprotocols.org/2023/1/e51531 %U https://doi.org/10.2196/51531 %U http://www.ncbi.nlm.nih.gov/pubmed/38113103 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e51427 %T A Relationship-Based Resilience Program for Promotores: Protocol for a Randomized Controlled Waitlist Trial %A Arcos,Daniela %A Russo,Lyric N %A Kazmierski,Kelly F M %A Zhou,Elayne %A Montiel,Gloria Itzel %A Bracho,America %A Mejia,Nancy %A Borelli,Jessica L %+ Department of Psychological Science, University of California Irvine, 401 E Peltason Drive, Irvine, CA, 92617, United States, 1 203 887 8857, jessica.borelli@uci.edu %K psychosocial intervention %K relational savoring %K cardiometabolic health %K community service providers %K Hispanic or Latinx %K CSP %D 2023 %7 19.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Community service providers (CSPs) play an integral role in the health care of low-income Hispanic or Latinx (HL) communities. CSPs have high-stress frontline jobs and share the high-risk demographics of their communities. Relational savoring (RS) has been associated with lower cardiovascular reactivity and psychosocial benefits, with particular promise among HL participants. In this study, we aim to identify RS’s potential in promoting CSPs’ cardiometabolic health and, in so doing, having broader impacts on the community they serve. Objective: This randomized controlled waitlist study aims to examine the effect of an RS intervention on (1) CSPs’ cardiometabolic health (cardiometabolic risk factors and outcomes) and (2) CSPs’ threats to leaving the workforce. Methods: We will recruit a sample of 80 CSPs from community health agencies serving low-income HL populations. Participating CSPs will be randomized into an experimental or a waitlist control. Participants will complete 1 or 2 baseline assessment batteries (before the intervention), depending on the assigned group, and then complete 2 more assessment batteries following the 4-week RS intervention (after the intervention and at a 3-mo follow-up). The RS intervention consists of guided reflections on positive moments of connection with others. Electrocardiogram data will be obtained from a wearable device (Polar Verity Sense or Movisens) to measure heart rate variability. The primary outcome is cardiometabolic health, consisting of cardiometabolic risk (obtained from heart rate variability) and cardiometabolic health behaviors. The secondary outcomes include CSPs’ threats to leaving the workforce (assessed via psychological well-being), intervention acceptability, and CSPs’ delivery of cardiometabolic health programming to the community (exploratory). Analyses of covariance will be used to examine the effects of RS on cardiometabolic health and on CSPs’ threats to leaving the workforce, comparing outcomes at baseline, postintervention, and at follow-up across participants in the experimental versus waitlist group. Results: The study has been approved by the University of California, Irvine, Institutional Review Board and is currently in the data collection phase. By May 2023, 37 HL CSPs have been recruited: 34 have completed the baseline assessment, 28 have completed the 4 intervention sessions, 27 have completed the posttreatment assessment, and 10 have completed all assessments (including the 3-mo follow-up). Conclusions: This study will provide valuable information on the potential of RS to support cardiometabolic health in HL CSPs and, indirectly, in the communities they serve. Trial Registration: ClinicalTrials.gov NCT05560893; https://clinicaltrials.gov/study/NCT05560893 International Registered Report Identifier (IRRID): DERR1-10.2196/51427 %M 38113093 %R 10.2196/51427 %U https://www.researchprotocols.org/2023/1/e51427 %U https://doi.org/10.2196/51427 %U http://www.ncbi.nlm.nih.gov/pubmed/38113093 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49352 %T Mobile Phone Technology for Preventing HIV and Related Youth Health Problems, Sexual Health, Mental Health, and Substance Use Problems in Southwest Uganda (Youth Health SMS): Protocol for a Pilot Randomized Controlled Trial %A Kreniske,Philip %A Namuyaba,Olive Imelda %A Kasumba,Robert %A Namatovu,Phionah %A Ssewamala,Fred %A Wingood,Gina %A Wei,Ying %A Ybarra,Michele L %A Oloya,Charlotte %A Tindyebwa,Costella %A Ntulo,Christina %A Mujune,Vincent %A Chang,Larry W %A Mellins,Claude A %A Santelli,John S %+ Community Health and Social Sciences Department, Graduate School of Public Health and Health Policy, City University of New York, 55 W 125th Street, New York, NY, 10027, United States, 1 (646) 364 9600, philip.kreniske@sph.cuny.edu %K adolescence %K PrEP %K pre-exposure prophylaxis %K HIV %K mental health %K substance use %K sexual health %K mobile phones %K randomized controlled trial %K adaptation %K Uganda %D 2023 %7 19.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: East and Southern Africa have the highest HIV incidence and prevalence in the world, with adolescents and young adults being at the greatest risk. Despite effective combination prevention tools, including the recently available pre-exposure prophylaxis (PrEP), HIV incidence among adolescents and young adults in Uganda remains high, and PrEP use remains low. Mental health and substance use (behavioral health) play a role in sexual behavior and decision-making, contributing to an increase in the risk for acquiring HIV. Interventions that target multiple HIV risk factors, including sexual and mental health and problematic substance use, are crucial to ending the HIV epidemic. Yet few interventions addressing HIV related health disparities and comorbidities among adolescents and young adults in East and Southern Africa currently exist. Objective: This study aims to evaluate the acceptability and feasibility of Kirabo, an SMS text message intervention informed by the information, motivation, and behavior model and to be disseminated through secondary schools. The study will gather preliminary estimates of Kirabo’s effectiveness in increasing HIV testing and linking users to mental health counselors. Methods: We identified Mobile 4 Reproductive Health for adaptation using the assessment, decision, administration, production, topical experts, integration, training, testing (ADAPT-ITT) framework. Mobile 4 Reproductive Health is an evidence-based automated 2-way SMS text messaging and interactive voice response platform that offers sexual and reproductive health information and links users to HIV clinics in East Africa. Through ADAPT-ITT we refined our approach and created Kirabo, an SMS text message–based intervention for linking adolescents and young adults to health services, including HIV testing and mental health counseling. We will conduct a 2-arm randomized controlled trial in Masaka, Uganda. Adolescents (N=200) will be recruited from local schools. Baseline sociodemographic characteristics, HIV test history, and behavioral health symptoms will be assessed. We will evaluate acceptability and feasibility using surveys, interviews, and mobile phone data. The preliminary efficacy of Kirabo in increasing HIV testing and linking users to mental health counselors will be evaluated immediately after the intervention and at the 3-month follow-up. We will also assess the intervention’s impact on self-efficacy in testing for HIV, adopting PrEP, and contacting a mental health counselor. Results: Intervention adaptation began in 2019. A pretest was conducted in 2021. The randomized controlled trial, including usability and feasibility assessments and effectiveness measurements, commenced in August 2023. Conclusions: Kirabo is a tool that assists in the efforts to end the HIV epidemic by targeting the health disparities and comorbidities among adolescents in Uganda. The intervention includes local HIV clinic information, PrEP information, and behavioral health screening, with referrals as needed. Increasing access to prevention strategies and mitigating factors that make adolescents and young adults susceptible to HIV acquisition can contribute to global efforts to end the HIV epidemic. Trial Registration: ClinicalTrials.gov NCT05130151; https://clinicaltrials.gov/study/NCT05130151 International Registered Report Identifier (IRRID): DERR1-10.2196/49352 %M 38113102 %R 10.2196/49352 %U https://www.researchprotocols.org/2023/1/e49352 %U https://doi.org/10.2196/49352 %U http://www.ncbi.nlm.nih.gov/pubmed/38113102 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 10 %N %P e43309 %T Stakeholders’ Perspectives, Needs, and Barriers to Self-Management for People With Physical Disabilities Experiencing Chronic Conditions: Focus Group Study %A Evans,Eric %A Zengul,Ayse %A Knight,Amy %A Willig,Amanda %A Cherrington,Andrea %A Mehta,Tapan %A Thirumalai,Mohanraj %+ Department of Health Services Administration, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, United States, 1 2059347189, mohanraj@uab.edu %K self-management %K physical disabilities %K physical disability %K chronic condition %K chronic illness %K mental health %K physical activity %K barrier %K disability %K chronic %K technology %K interview %K data %K symptom %K support %K digital %K development %K need %K perspective %K barrier %K qualitative %K focus group %K assistive technology %K assistive technologies %D 2023 %7 18.12.2023 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: While self-management programs have had significant improvements for individuals with chronic conditions, less is known about the impact of self-management programs for individuals with physical disabilities who experience chronic conditions, as no holistic self-management programs exist for this population. Similarly, there is limited knowledge of how other stakeholders, such as caregivers, health experts, and researchers, view self-management programs in the context of disability, chronic health conditions, and assistive technologies. Objective: This study aimed to obtain insight into how stakeholders perceive self-management relating to physical disability, chronic conditions, and assistive technologies. Methods: Nine focus groups were conducted by 2 trained facilitators using semistructured interview guides. Each guide contained questions relating to stakeholders’ experiences, challenges with self-management programs, and perceptions of assistive technologies. Focus groups were audio recorded and transcribed. Thematic analysis was conducted on the focus group data. Results: A total of 47 individuals participated in the focus groups. By using a constructivist grounded approach and inductive data collection, three main themes emerged from the focus groups: (1) perspectives, (2) needs, and (3) barriers of stakeholders. Stakeholders emphasized the importance of physical activity, mental health, symptom management, medication management, participant centeredness, and chronic disease and disability education. Participants viewed technology as a beneficial aide to their daily self-management and expressed their desire to have peer-to-peer support in web-based self-management programs. Additional views of technology included the ability to access individualized, educational content and connect with other individuals who experience similar health conditions or struggle with caregiving duties. Conclusions: The findings suggest that the development of any web-based self-management program should include mental health education and resources in addition to physical activity content and symptom management and be cost-effective. Beyond the inclusion of educational resources, stakeholders desired customization or patient centeredness in the program to meet the overall needs of individuals with physical disabilities and caregivers. The development of web-based self-management programs should be holistic in meeting the needs of all stakeholders. Trial Registration: ClinicalTrials.gov NCT05481593; https://clinicaltrials.gov/study/NCT05481593 %M 38109170 %R 10.2196/43309 %U https://rehab.jmir.org/2023/1/e43309 %U https://doi.org/10.2196/43309 %U http://www.ncbi.nlm.nih.gov/pubmed/38109170 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e52804 %T Exploring the Number of Web-Based Behavioral Health Coaching Sessions Associated With Symptom Improvement in Youth: Observational Retrospective Analysis %A Lawrence-Sidebottom,Darian %A Huffman,Landry Goodgame %A Beam,Aislinn %A Guerra,Rachael %A Parikh,Amit %A Roots,Monika %A Huberty,Jennifer %+ Bend Health, Inc, 9450 SW Gemini Drive #58509, Beaverton, OR, 97008, United States, 1 7708619131, landry.huffman@bendhealth.com %K adolescents %K anxiety %K children %K depression %K digital mental health intervention %K reliable change %D 2023 %7 18.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Rates of anxiety and depression have been increasing among children and adolescents for the past decade; however, many young people do not receive adequate mental health care. Digital mental health interventions (DMHIs) that include web-based behavioral health coaching are widely accessible and can confer significant improvements in youth anxiety and depressive symptoms. However, more research is necessary to determine the number of web-based coaching sessions that confer clinically significant improvements in anxiety and depressive symptoms in youth. Objective: This study uses data from a pediatric DMHI to explore the number of web-based coaching sessions required to confer symptom improvements among children and adolescents with moderate or moderately severe symptoms of anxiety and depression. Methods: We used retrospective data from a pediatric DMHI that offered web-based behavioral health coaching in tandem with self-guided access to asynchronous chat with practitioners, digital mental health resources, and web-based mental health symptom assessments. Children and adolescents who engaged in 3 or more sessions of exclusive behavioral health coaching for moderate to moderately severe symptoms of anxiety (n=66) and depression (n=59) were included in the analyses. Analyses explored whether participants showed reliable change (a decrease in symptom scores that exceeds a clinically established threshold) and stable reliable change (at least 2 successive assessments of reliable change). Kaplan-Meier survival analyses were performed to determine the median number of coaching sessions when the first reliable change and stable reliable change occurred for anxiety and depressive symptoms. Results: Reliable change in anxiety symptoms was observed after a median of 2 (95% CI 2-3) sessions, and stable reliable change in anxiety symptoms was observed after a median of 6 (95% CI 5-8) sessions. A reliable change in depressive symptoms was observed after a median of 2 (95% CI 1-3) sessions, and a stable reliable change in depressive symptoms was observed after a median of 6 (95% CI 5-7) sessions. Children improved 1-2 sessions earlier than adolescents. Conclusions: Findings from this study will inform caregivers and youth seeking mental health care by characterizing the typical time frame in which current participants show improvements in symptoms. Moreover, by suggesting that meaningful symptom improvement can occur within a relatively short time frame, these results bolster the growing body of research that indicates web-based behavioral health coaching is an effective form of mental health care for young people. %M 38109174 %R 10.2196/52804 %U https://formative.jmir.org/2023/1/e52804 %U https://doi.org/10.2196/52804 %U http://www.ncbi.nlm.nih.gov/pubmed/38109174 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e53094 %T Evaluation of a Cannabis Harm Reduction Intervention for People With First-Episode Psychosis: Protocol for a Pilot Multicentric Randomized Trial %A Coronado-Montoya,Stephanie %A Abdel-Baki,Amal %A Côté,José %A Crockford,David %A Dubreucq,Simon %A Fischer,Benedikt %A Lachance-Touchette,Pamela %A Lecomte,Tania %A L'Heureux,Sophie %A Ouellet-Plamondon,Clairélaine %A Roy,Marc-André %A Tatar,Ovidiu %A Tibbo,Phillip %A Villeneuve,Marie %A Wittevrongel,Anne %A Jutras-Aswad,Didier %+ Research Centre, Centre Hospitalier de l’Université de Montréal, CHUM Research Centre, 900 St-Denis, Viger Tower, room R05.746, Montréal, QC, H2X 1P1, Canada, 1 514 890 8000 ext 35703, didier.jutras-aswad@umontreal.ca %K cannabis, psychosis, harm reduction, pilot, mobile health %K psychological intervention %K mHealth %K young adult %K schizophrenia %K motivational interviewing %K intervention %K RCT %K randomized %K controlled trial %K controlled trials %K multi-centric %K young people %K clinical trials %K feasibility %K perspectives %K perspective %K evidence-based %D 2023 %7 18.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cannabis use is highly prevalent in young people with first-episode psychosis (FEP). Most report cannabis use and are often diagnosed with a cannabis use disorder upon admission to specialized services for psychosis. Cannabis use in this population is associated with worse clinical and psychosocial outcomes, rendering it an important clinical target. Despite this, few cannabis-specific interventions have been developed for FEP and empirically evaluated through randomized controlled trials. Most evaluated interventions have targeted cannabis abstinence, with limited efficacy, but none have centered on harm reduction outcomes for people with FEP who use cannabis. Early intervention services (EIS), the standard of care for FEP, have not successfully addressed problematic cannabis use in people with FEP either. Clinical trials are needed to explore the potential of harm reduction strategies, although these should be preceded by robust pilot studies to establish optimal design and approaches. Objective: Recognizing the need for harm reduction strategies for individuals with FEP who use cannabis and based on research on patients’ preferences supporting harm reduction interventions, we developed a mobile app–based cannabis harm reduction intervention for this population. This intervention is called Cannabis Harm–reducing Application to Manage Practices Safely (CHAMPS). Here, we describe the protocol for a multicenter, 2-arm, parallel group, randomized pilot trial evaluating the acceptability of CHAMPS for people with FEP who use cannabis and the feasibility of conducting a full-scale trial in this population using CHAMPS. The impact on key clinical outcomes will also be explored. Methods: This pilot trial aims to recruit 100 young people with FEP using cannabis from 6 Canadian EIS clinics. Participants will be randomized in a 1:1 ratio to CHAMPS+EIS or EIS-only. CHAMPS acceptability will be assessed using completion rates for the intervention arm. Trial feasibility will be assessed using a retention rate for randomized participants. Secondary outcomes will explore tendencies of change in the use of protective behavioral strategies and in motivation to change strategies. Exploratory outcomes include cannabis use–related problems, other substance use, the severity of dependence, psychotic symptoms, and health care service use. Results: Recruitment began in December 2021. Data collection and analysis are expected to be completed in early 2024. Study results describing CHAMPS acceptability and trial feasibility will then be submitted for publication in a peer-reviewed journal. Conclusions: CHAMPS uniquely combines evidence-based approaches, patient perspectives, and mobile health technology to support harm reduction in people with FEP who use cannabis. Attaining adequate acceptability and feasibility through this trial may justify further exploration of harm reduction tools, particularly within the context of conducting a larger-scale randomized controlled trial. This pilot trial has the potential to advance knowledge for researchers and clinicians regarding a feasible and user-acceptable research design in the cannabis and early psychosis fields. Trial Registration: ClinicalTrials.gov NCT04968275, https://clinicaltrials.gov/ct2/show/NCT04968275 International Registered Report Identifier (IRRID): DERR1-10.2196/53094 %M 38109196 %R 10.2196/53094 %U https://www.researchprotocols.org/2023/1/e53094 %U https://doi.org/10.2196/53094 %U http://www.ncbi.nlm.nih.gov/pubmed/38109196 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e49685 %T Development and Formative Evaluation of a Virtual Exercise Platform for a Community Fitness Center Serving Individuals With Physical Disabilities: Mixed Methods Study %A Mohanraj,Sangeetha %A Malone,Laurie A %A Mendonca,Christen J %A Thirumalai,Mohanraj %+ Department of Health Services Administration, School of Health Professions, The University of Alabama at Birmingham, 1716, 9th Avenue S, SHP # 590 D, Birmingham, AL, 35233, United States, 1 2059347189, mohanraj@uab.edu %K web-based exercise %K user experience %K community health %K fitness facility %K tele-exercise %K physical disability %K physical activity %K exercise %K fitness %K virtual %K interface %K disability %K disabilities %K accessibility %K telehealth %K telemedicine %K eHealth %K digital health %K mixed methods study %D 2023 %7 15.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: People with disabilities experience numerous barriers to being physically active, such as transportation issues, a lack of trained exercise professionals who understand disabilities, and facility access. The use of a virtual exercise platform (VEP) may provide an alternative and limit certain barriers. Objective: The aim of this mixed method study was to evaluate user interaction (effectiveness, efficiency, and satisfaction), the strengths and weaknesses of the user interface, and the user experience with a VEP. Methods: Participants were recruited from a community fitness facility that offers programs for people with disabilities. Inclusion criteria were being older than 18 years, fluent in English, and availability of internet access. Features of the VEP included articles, prerecorded videos, live Zoom classes, web-based class registration, weekly progress tracking, incentives, and surveys. A one-on-one Zoom session was scheduled with each participant, during which they completed certain tasks: (1) create an account or login, (2) register for class, (3) join class, (4) add to calendar, and (5) complete surveys. As participants completed tasks, quantitative observations (time on task, task success, rate of task completion, and number of errors by users, which determined task difficulty), qualitative observations were made and interviews were conducted at the end of the session. The “concurrent think-aloud” method was encouraged by the moderator to gauge participants’ thoughts as they worked through testing. Participants also completed the System Usability Scale (SUS) and Questionnaire for User Interface Satisfaction (QUIS). Results: A total of 5 people with disabilities (3 male, 2 female), aged 36-78 (mean 54) years, with education levels from high school to PhD, were recruited. Devices used for testing included a laptop (n=3), a Chromebook (n=1), and a desktop (n=1). All participants completed tasks #1 and #2 without errors but could not complete task #4. One participant completed task #5 with difficulty and another completed task #3 with difficulty. The average time to complete each task was: (1) 82 seconds (55-110), (2) 11 seconds (4-21), (3) 9 seconds (5-27), and (4) 921.5 seconds (840-958). The mean SUS score was 86.5/100, and the mean user QUIS score was 8.08 out of 10. Qualitative observations indicated that the system was simple, user-friendly, and accessible. Conclusions: People with disabilities reported high usability and user satisfaction with the web-based exercise platform, and the system appears to be an efficient and effective physical activity option. %M 38100173 %R 10.2196/49685 %U https://formative.jmir.org/2023/1/e49685 %U https://doi.org/10.2196/49685 %U http://www.ncbi.nlm.nih.gov/pubmed/38100173 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44002 %T Psychosocial Outcomes Among Users and Nonusers of Open-Source Automated Insulin Delivery Systems: Multinational Survey of Adults With Type 1 Diabetes %A Schipp,Jasmine %A Hendrieckx,Christel %A Braune,Katarina %A Knoll,Christine %A O’Donnell,Shane %A Ballhausen,Hanne %A Cleal,Bryan %A Wäldchen,Mandy %A Lewis,Dana M %A Gajewska,Katarzyna A %A Skinner,Timothy C %A Speight,Jane %+ The Australian Centre for Behavioural Research in Diabetes, Suite G01, 15-31 Pelham Street, Carlton, 3053, Australia, 61 03 9244 6448, schippj@deakin.edu.au %K artificial %K diabetes mellitus %K hypoglycaemia %K pancreas %K patient-reported outcome measures, surveys, and questionnaires %K quality of life %K sleep quality %K type 1 %D 2023 %7 14.12.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Emerging research suggests that open-source automated insulin delivery (AID) may reduce diabetes burden and improve sleep quality and quality of life (QoL). However, the evidence is mostly qualitative or uses unvalidated, study-specific, single items. Validated person-reported outcome measures (PROMs) have demonstrated the benefits of other diabetes technologies. The relative lack of research investigating open-source AID using PROMs has been considered a missed opportunity. Objective: This study aimed to examine the psychosocial outcomes of adults with type 1 diabetes using and not using open-source AID systems using a comprehensive set of validated PROMs in a real-world, multinational, cross-sectional study. Methods: Adults with type 1 diabetes completed 8 validated measures of general emotional well-being (5-item World Health Organization Well-Being Index), sleep quality (Pittsburgh Sleep Quality Index), diabetes-specific QoL (modified DAWN Impact of Diabetes Profile), diabetes-specific positive well-being (4-item subscale of the 28-item Well-Being Questionnaire), diabetes treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire), diabetes distress (20-item Problem Areas in Diabetes scale), fear of hypoglycemia (short form of the Hypoglycemia Fear Survey II), and a measure of the impact of COVID-19 on QoL. Independent groups 2-tailed t tests and Mann-Whitney U tests compared PROM scores between adults with type 1 diabetes using and not using open-source AID. An analysis of covariance was used to adjust for potentially confounding variables, including all sociodemographic and clinical characteristics that differed by use of open-source AID. Results: In total, 592 participants were eligible (attempting at least 1 questionnaire), including 451 using open-source AID (mean age 43, SD 13 years; n=189, 41.9% women) and 141 nonusers (mean age 40, SD 13 years; n=90, 63.8% women). Adults using open-source AID reported significantly better general emotional well-being and subjective sleep quality, as well as better diabetes-specific QoL, positive well-being, and treatment satisfaction. They also reported significantly less diabetes distress, fear of hypoglycemia, and perceived less impact of the COVID-19 pandemic on their QoL. All were medium-to-large effects (Cohen d=0.5-1.5). The differences between groups remained significant after adjusting for sociodemographic and clinical characteristics. Conclusions: Adults with type 1 diabetes using open-source AID report significantly better psychosocial outcomes than those not using these systems, after adjusting for sociodemographic and clinical characteristics. Using validated, quantitative measures, this real-world study corroborates the beneficial psychosocial outcomes described previously in qualitative studies or using unvalidated study-specific items. %M 38096018 %R 10.2196/44002 %U https://www.jmir.org/2023/1/e44002 %U https://doi.org/10.2196/44002 %U http://www.ncbi.nlm.nih.gov/pubmed/38096018 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e50806 %T Efficacy of a Smartphone App in Enhancing Medication Adherence and Accuracy in Individuals With Schizophrenia During the COVID-19 Pandemic: Randomized Controlled Trial %A Chen,Huan Hwa %A Hsu,Hsin Tien %A Lin,Pei Chao %A Chen,Chin-Yin %A Hsieh,Hsiu Fen %A Ko,Chih Hung %+ College of Nursing, Kaohsiung Medical University, 100 Shih-Chuan 1st Rd., Sanmin District, Kaohsiung, 80708, Taiwan, 886 7 3121101 ext 2626, hsiufen96@kmu.edu.tw %K cognitive functions %K medication adherence %K psychiatric symptoms %K schizophrenia %K smartphone app %D 2023 %7 14.12.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Poor medication adherence or inaccuracy in taking prescribed medications plays an important role in the recurrence or worsening of psychiatric symptoms in patients with schizophrenia, and the COVID-19 pandemic impacted their medication adherence with exacerbated symptoms or relapse. The use of mobile health services increased during the COVID-19 pandemic, and their role in improving mental health is becoming clearer. Objective: This study aimed to explore the effectiveness of a smartphone app (MedAdhere) on medication adherence and accuracy among patients with schizophrenia and to measure their psychiatric symptoms and cognitive functions. Methods: In this 12-week experimental study, participants were provided interventions with the MedAdhere app, and data were collected between June 2021 and September 2022. A total of 105 participants were randomly assigned to either the experimental or control groups. We used the Positive and Negative Syndrome Scale and Mini-Mental State Examination to measure the participants’ psychiatric symptoms and cognitive functions. Generalized estimating equations were used for data analysis. Results: A total of 94 participants met the inclusion criteria and completed the protocol, and the medication adherence rate of the experimental group was 94.72% (2785/2940) during the intervention. Psychotic symptoms (positive, negative, and general psychopathology symptoms) and cognitive functions (memory, language, and executive function) were significantly improved in the experimental group compared to the control group after the intervention. Conclusions: The MedAdhere app effectively and significantly improved medication adherence and, thereby, the psychiatric symptoms of patients with schizophrenia. This artificial intelligence assisted app could be extended to all patients who need to be reminded to take medication on schedule. Trial Registration: ClinicalTrials.gov NCT05892120; https://clinicaltrials.gov/study/NCT05892120 %M 38096017 %R 10.2196/50806 %U https://mental.jmir.org/2023/1/e50806 %U https://doi.org/10.2196/50806 %U http://www.ncbi.nlm.nih.gov/pubmed/38096017 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 7 %N %P e49345 %T Outcomes of a Remote Cardiac Rehabilitation Program for Patients Undergoing Atrial Fibrillation Ablation: Pilot Study %A Misra,Satish %A Niazi,Karen %A Swayampakala,Kamala %A Blackmon,Amanda %A Lang,Melissa %A Davenport,Elizabeth %A Saxonhouse,Sherry %A Fedor,John %A Powell,Brian %A Thompson,Joseph %A Holshouser,John %A Mehta,Rohit %+ Sanger Heart and Vascular Institute, 1237 Harding Place, Charlotte, NC, 28204, United States, 1 7043730212, satish.misra@atriumhealth.org %K atrial fibrillation %K behavior modification %K cardiac rehabilitation %K catheter ablation %K exercise %K remote exercise supervision %K weight loss %D 2023 %7 14.12.2023 %9 Original Paper %J JMIR Cardio %G English %X Background: Risk factor modification, in particular exercise and weight loss, has been shown to improve outcomes for patients with atrial fibrillation (AF). However, access to structured supporting programs is limited. Barriers include the distance from appropriate facilities, insurance coverage, work or home responsibilities, and transportation. Digital health technology offers an opportunity to address this gap and offer scalable interventions for risk factor modification. Objective: This study aims to assess the feasibility and effectiveness of a 12-week asynchronous remotely supervised exercise and patient education program, modeled on cardiac rehabilitation programs, in patients with AF. Methods: A total of 12 patients undergoing catheter ablation of AF were enrolled in this pilot study. Participants met with an exercise physiologist for a supervised exercise session to generate a personalized exercise plan to be implemented over the subsequent 12-week program. Disease-specific education was also provided as well as instruction in areas such as blood pressure and weight measurement. A digital health toolkit for self-tracking was provided to facilitate monitoring of exercise time, blood pressure, weight, and cardiac rhythm. The exercise physiologist remotely monitored participants and completed weekly check-ins to titrate exercise targets and provide further education. The primary end point was program completion. Secondary end points included change in self-tracking adherence, weight, 6-minute walk test (6MWT), waist circumference, AF symptom score, and program satisfaction. Results: The median participant age was 67.5 years, with a mean BMI of 33.8 kg/m2 and CHADs2VASC (Congestive Heart Failure, Hypertension, Age [≥75 years], Diabetes, Stroke/Transient Ischemic Attack, Vascular Disease, Age [65-74 years], Sex [Female]) of 1.5. A total of 11/12 (92%) participants completed the program, with 94% of expected check-ins completed and 2.9 exercise sessions per week. Adherence to electrocardiogram and blood pressure tracking was fair at 81% and 47%, respectively. Significant reductions in weight, waist circumference, and BMI were observed with improvements in 6MWT and AF symptom scores (P<.05) at the completion of the program. For program management, a mean of 2 hours per week or 0.5 hours per patient per week was required, inclusive of time for follow-up and intake visits. Participants rated the program highly (>8 on a 10-point Likert scale) in terms of the impact on health and wellness, educational value, and sustainability of the personal exercise program. Conclusions: An asynchronous remotely supervised exercise program augmented with AF-specific educational components for patients with AF was feasible and well received in this pilot study. While improvements in patient metrics like BMI and 6MWT are encouraging, they should be viewed as hypothesis generating. Based on insights gained, future program iterations will include particular attention to improved technology for data aggregation, adjustment of self-monitoring targets based on observed adherence, and protocol-driven exercise titration. The study design will need to incorporate strategies to facilitate the recruitment of a diverse and representative participant cohort. %M 38096021 %R 10.2196/49345 %U https://cardio.jmir.org/2023/1/e49345 %U https://doi.org/10.2196/49345 %U http://www.ncbi.nlm.nih.gov/pubmed/38096021 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 12 %N %P e47250 %T Phone-Based Text Therapy for Youth Mental Health: Rapid Review %A Karnik,Varun %A Henderson,Hamish %A Khan,Urooj Raza %A Boyd,James %+ La Trobe University, 360 Collins Street, Melbourne, 3086, Australia, 61 3 9479 6000, varun.karnik@griffithuni.edu.au %K text therapy %K mHealth %K adolescent health %K distance counseling %K mental illness %K mobile health intervention %K adolescent %K health promotion %K digital mental health intervention %D 2023 %7 14.12.2023 %9 Review %J Interact J Med Res %G English %X Background: Mental illness has become a prevalent issue impacting adolescents worldwide. Many barriers, including stigma and poor health literacy, prevent this population group from accessing reliable mental health care services. Synchronous text–therapy counseling is an underused therapeutic approach in combating adolescent mental illness. Phone-based text therapy is uniquely placed to offer personalized counseling to adolescents through a familiar and engaging treatment modality. Objective: This rapid review aims to understand the clinical effectiveness, usability, and accessibility of phone-based text therapy for youth mental health. Methods: Cochrane CENTRAL, Embase, PubMed, and PsycINFO were used to search for suitable literature. Five groups of keywords were used: those related to (1) “therapy,” (2) “text,” (3) “phone,” (4) “youth,” and (5) “mental health.” Eligibility criteria were formed through the PICO (Population, Intervention, Control, and Outcome) framework. Studies were included if a synchronous phone-based text therapy intervention was used in an adolescent population, with an age range of 12-24 years. Only literature available in full-text, English, and a peer-reviewed journal was considered. Furthermore, a date limit of 5 years was set to reflect the recent development of digital interventions for mental health. Pertinent information from each study was tabulated, and a narrative synthesis was used to assess, describe, and organize the included studies comprehensively and concisely. Results: Of the 771 studies dual screened, 7 studies were included in this rapid review. Most of the exclusions occurred due to the use of the wrong intervention, such as asynchronous messaging. The selected studies had a low risk of bias and were suitable for the review. All interventional trials demonstrated reductions in mental health symptoms, primarily depression and anxiety. Most studies displayed high usability among participants, while data were unclear regarding accessibility. Conclusions: This review reveals the high potential of phone-based text therapy as an intervention for adolescents experiencing mental illness. We hope that this review promotes further refinement of text-based phone therapies and encourages future research on this subject matter. %M 38096012 %R 10.2196/47250 %U https://www.i-jmr.org/2023/1/e47250 %U https://doi.org/10.2196/47250 %U http://www.ncbi.nlm.nih.gov/pubmed/38096012 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e48704 %T Wearable Activity Trackers That Motivate Women to Increase Physical Activity: Mixed Methods Study %A Peterson,Neil E %A Bate,Danielle A %A Macintosh,Janelle LB %A Trujillo Tanner,Corinna %+ College of Nursing, Brigham Young University, 500 Spencer W. Kimball Tower, Provo, UT, 84602, United States, 1 8014224893, neil-peterson@byu.edu %K physical activity %K women %K motivation %K wearable activity trackers %K mobile health %K mHealth %K self-determination %K mobile phone %D 2023 %7 14.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Physical inactivity is a significant public health concern, particularly among women in the United States. Wearable activity trackers (WATs) have been proposed as a potential solution to increase awareness of and engagement in physical activity (PA). However, to be effective, WATs must include features and designs that encourage daily use. Objective: This study aims to explore the features and designs of WATs that appeal to women and determine whether devices with these attributes are effective motivators for women to be physically active. Methods: A mixed methods study guided by the self-determination theory was conducted among 15 women. Participants trialed 3 WATs with influence in their respective accessory domains: Apple Watch for the wrist; Oura Ring for the finger; and Bellabeat Leaf Urban for multiple sites (it can be worn as a bracelet, necklace, or clip). Participants documented their daily PA levels and rated their satisfaction with each device’s comfort, features, and motivational effect. Focus groups were also conducted to gather additional feedback and experiences within the a priori areas of comfort, features, and motivation. Results: Behavioral Regulation in Exercise Questionnaire–2 scores indicated that most participants (14/15, 93%) were motivated at baseline (amotivation score: mean 0.13, SD 0.45), but on average, participants did not meet the national minimum PA guidelines according to the self-reported Physical Activity Vital Sign questionnaire (moderate to vigorous PA score: mean 144, SD 97.5 min/wk). Mean WAT wear time was 16.9 (SD 4.4) hours, 19.4 (SD 5.3) hours, and 20.4 (SD 4.7) hours for Apple Watch, Bellabeat Leaf Urban, and Oura Ring, respectively. During focus groups, participants reinforced their quantitative ratings and rankings of the WATs based on personal experiences. Participants shared a variety of both activity-related and non–activity-related features that they look for in a motivating device. When considering what the ideal WAT would be for a woman, participants suggested features of (1) comfort, (2) extended battery life, (3) durability, (4) immediate PA feedback, (5) intuitive PA sensing, and (6) programmability. Conclusions: This study is the first to specifically address women’s experiences with and preferences for different types of WATs. Those who work with women should realize how they view WATs and the role they play in motivation to be active. %M 38096000 %R 10.2196/48704 %U https://formative.jmir.org/2023/1/e48704 %U https://doi.org/10.2196/48704 %U http://www.ncbi.nlm.nih.gov/pubmed/38096000 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e50371 %T Digital Support Systems to Improve Child Health and Development in Peru: Protocol for a Randomized Controlled Trial %A Hartinger Pena,Stella Maria %A Mäusezahl,Daniel %A Jäggi,Lena %A Aguilar,Leonel %A Alvarado Llatance,Milagros %A Castellanos,Andreana %A Huaylinos Bustamante,Maria-Luisa %A Hinckley,Kristen %A Charles McCoy,Dana %A Zhang,Ce %A Fink,Günther %+ Swiss Tropical and Public Health Institute, Kreuzstrasse 2, Allschwil, 4123, Switzerland, 41 (0)61384 0, guenther.fink@swisstph.ch %K child development %K digital support %K parenting %K Peru %K child %K children %K childhood %K parent %K parents %K parenting %K education %K support %K parental %K cost %K low income %K low resource %K digital health %K platforms %K pediatric %K pediatrics %K eHealth %K e-health %K RCT %K RCTs %K randomized %K controlled trial %K development %K scalable %D 2023 %7 14.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Children living in low and middle-income countries (LMICs) are at greater risk for experiencing adversities that can undermine their health and early development. Recently launched digital early childhood development (ECD) programs attempt to support families with young children in their home environments using digital technologies. However, relatively little is known regarding the effectiveness of these new technologies. Objective: The goal of this study is to rigorously assess the reach, effectiveness, and cost-effectiveness of a newly developed digital ECD platform called Afini. The Afini platform was designed to support parents of young children in low-resource settings to improve ECD and interact with caregivers through messenger services and a chatbot. Methods: This is a 3-arm cluster randomized controlled trial. In total, 2471 caregivers and their 3- to 9-month-old children were enrolled in the study across 164 study clusters in the San Marcos, Cajabamba, and Cajamarca provinces of Peru. Clusters of participants were randomly assigned to 1 of 3 groups: a control group (72 community clusters and 980 caregiver-child dyads), a home visit intervention group (20 community clusters and 316 caregiver-child dyads), and an Afini intervention group (72 community clusters and 1175 caregiver-child dyads). Families in the control group receive no focused ECD intervention. The home visit group is receiving biweekly home visits by a trained field staff following the national ECD program (Programa Nacional Cuna Más) curriculum and training guidelines. Caregivers in the Afini group are receiving ECD activities and advice through the digital platform. The primary study outcome is children’s overall development at the age of 2.5 years, using the internationally validated long form of the Global Scales for Early Development. Secondary outcomes include caregiver engagement; caregiver mental health; screen time; as well as caregiver reports of children’s motor, cognitive, language, and socioemotional development measured through locally piloted and validated tools. Results: Enrollment started in September 2021 and ended in March 2023. Endline assessments will take place between August 2023 and September 2024. Conclusions: This study is, to our knowledge, the first to rigorously assess the effectiveness and cost-effectiveness of digital ECD technologies in LMICs. Given the large number of children in LMICs currently receiving only limited external support, the evaluated platform has the potential to improve the short- and long-term well-being of millions of children and their parents globally. Trial Registration: ClinicalTrials.gov NCT05202106; https://clinicaltrials.gov/ct2/show/NCT05202106 International Registered Report Identifier (IRRID): DERR1-10.2196/50371 %M 38096020 %R 10.2196/50371 %U https://www.researchprotocols.org/2023/1/e50371 %U https://doi.org/10.2196/50371 %U http://www.ncbi.nlm.nih.gov/pubmed/38096020 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48852 %T A Machine Learning Model to Predict Patients’ Adherence Behavior and a Decision Support System for Patients With Metastatic Breast Cancer: Protocol for a Randomized Controlled Trial %A Masiero,Marianna %A Spada,Gea Elena %A Sanchini,Virginia %A Munzone,Elisabetta %A Pietrobon,Ricardo %A Teixeira,Lucas %A Valencia,Mirtha %A Machiavelli,Aline %A Fragale,Elisa %A Pezzolato,Massimo %A Pravettoni,Gabriella %+ Department of Oncology and Hemato-oncology, University of Milan, Via Festa del Perdono 7, Milan, 20122, Italy, 39 0294372099, marianna.masiero@unimi.it %K adherence %K metastatic breast cancer %K decision-making %K personality %K risk-predictive model %K decision support system %K oral therapies %K machine learning %K behavior %K cancer %K breast cancer %D 2023 %7 14.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adherence to oral anticancer treatments is critical in the disease trajectory of patients with breast cancer. Given the impact of nonadherence on clinical outcomes and the associated economic burden for the health care system, finding ways to increase treatment adherence is particularly relevant. Objective: The primary end point is to evaluate the effectiveness of a decision support system (DSS) and a machine learning web application in promoting adherence to oral anticancer treatments among patients with metastatic breast cancer. The secondary end point is to collect a set of new physical, psychological, social, behavioral, and quality of life predictive variables that could be used to refine the preliminary version of the machine learning model to predict patients’ adherence behavior. Methods: This prospective, randomized controlled study is nested in a large-scale international project named “Enhancing therapy adherence among metastatic breast cancer patients” (Pfizer 65080791), aimed to develop a predictive model of nonadherence and associated DSS and guidelines to foster patients’ engagement and therapy adherence. A web-based DSS named TREAT (treatment adherence support) was developed using a patient-driven approach, with 4 sections, that is, Section A: Metastatic Breast Cancer; Section B: Adherence to Cancer Therapies; Section C: Promoting Adherence; and Section D: My Adherence Diary. Moreover, a machine learning–based web application was developed to predict patients' risk factors of adherence to anticancer treatment, specifically pertaining to physical status and comorbid conditions, as well as short and long-term side effects. Overall, 100 patients consecutively admitted at the European Institute of Oncology (IEO) at the Division of Medical Senology will be enrolled; 50 patients with metastatic breast cancer will be exposed to the DSS and machine learning web application for 3 months (experimental group), and 50 patients will not be exposed to the intervention (control group). Each participant will fill a weekly medication diary and a set of standardized self-reports evaluating psychological and quality of life variables (Adherence Attitude Inventory, Beck Depression Inventory-II, Brief Pain Inventory, 13-item Sense of Coherence scale, Brief Italian version of Cancer Behavior Inventory, European Organization for Research and Treatment of Cancer Quality of Life 23-item Breast Cancer-specific Questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, 8-item Morisky Medication Adherence Scale, State-Trait Anxiety Inventory forms I and II, Big Five Inventory, and visual analogue scales evaluating risk perception). The 3 assessment time points are T0 (baseline), T1 (1 month), T2 (2 months), and T3 (3 months). This study was approved by the IEO ethics committee (R1786/22-IEO 1907). Results: The recruitment process started in May 2023 and is expected to conclude on December 2023. Conclusions: The contribution of machine learning techniques through risk-predictive models integrated into DSS will enable medication adherence by patients with cancer. Trial Registration: ClinicalTrials.gov NCT06161181; https://clinicaltrials.gov/study/NCT06161181 International Registered Report Identifier (IRRID): DERR1-10.2196/48852 %M 38096002 %R 10.2196/48852 %U https://www.researchprotocols.org/2023/1/e48852 %U https://doi.org/10.2196/48852 %U http://www.ncbi.nlm.nih.gov/pubmed/38096002 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e47860 %T A Personalized, Transdiagnostic Smartphone Intervention (Mello) Targeting Repetitive Negative Thinking in Young People With Depression and Anxiety: Pilot Randomized Controlled Trial %A Bell,Imogen %A Arnold,Chelsea %A Gilbertson,Tamsyn %A D’Alfonso,Simon %A Castagnini,Emily %A Chen,Nicola %A Nicholas,Jennifer %A O’Sullivan,Shaunagh %A Valentine,Lee %A Alvarez-Jimenez,Mario %+ Orygen, 35 Poplar Rd, Melbourne, 3052, Australia, 61 3 99669177, imogen.bell@orygen.org.au %K repetitive negative thinking %K rumination %K anxiety %K depression %K mobile app %K just-in-time adaptive interventions %K youth mental health %K adolescent %K mobile phone %D 2023 %7 13.12.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Repetitive negative thinking (RNT) is a key transdiagnostic mechanism underpinning depression and anxiety. Using “just-in-time adaptive interventions” via smartphones may disrupt RNT in real time, providing targeted and personalized intervention. Objective: This pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary clinical outcomes and mechanisms of Mello—a fully automated, personalized, transdiagnostic, and mechanistic smartphone intervention targeting RNT in young people with depression and anxiety. Methods: Participants with heightened depression, anxiety, and RNT were recruited via social media and randomized to receive Mello or a nonactive control over a 6-week intervention period. Assessments were completed via Zoom sessions at baseline and at 3 and 6 weeks after baseline. Results: The findings supported feasibility and acceptability, with high rates of recruitment (N=55), uptake (55/64, 86% of eligible participants), and retention (52/55, 95% at 6 weeks). Engagement was high, with 90% (26/29) and 59% (17/29) of the participants in the Mello condition still using the app during the third and sixth weeks, respectively. Greater reductions in depression (Cohen d=0.50), anxiety (Cohen d=0.61), and RNT (Cohen d=0.87) were observed for Mello users versus controls. Mediation analyses suggested that changes in depression and anxiety were accounted for by changes in RNT. Conclusions: The results indicate that mechanistic, targeted, and real-time technology-based solutions may provide scalable and effective interventions that advance the treatment of youth mental ill health. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621001701819; http://tinyurl.com/4d3jfj9f %M 38090786 %R 10.2196/47860 %U https://www.jmir.org/2023/1/e47860 %U https://doi.org/10.2196/47860 %U http://www.ncbi.nlm.nih.gov/pubmed/38090786 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46858 %T Online Support Groups for Family Caregivers: Scoping Review %A Daynes-Kearney,Rosemary %A Gallagher,Stephen %+ Study of Anxiety, Stress and Health Laboratory, Department of Psychology, University of Limerick, Limerick, V94T9PX, Ireland, 353 61233618, rosemary.daynes.kearney@ul.ie %K caregivers %K carer %K caregiver %K caregiving %K informal care %K family care %K unpaid care %K spousal care %K carers %K online support groups %K scoping review %K review methods %K review methodology %K social support %K review %K support %K peer support %K online support %K development %K communication %K psychosocial %K life experience %K caregiver needs %K engagement %D 2023 %7 13.12.2023 %9 Review %J J Med Internet Res %G English %X Background: Caregiving can affect people of all ages and can have significant negative health impacts on family caregivers themselves. Research has shown that social support acts as a buffer against many negative health impacts. A common source of social support is support groups. Although traditionally, these groups were conducted in a face-to-face setting, the advent of the internet, social media applications, and the smartphone have seen online support groups (OSGs) develop as a space where many caregivers seek support. The number of OSGs has increased exponentially, but there is no clear consensus on what factors or characteristics of OSGs contribute to social support development within them or what types of OSGs are available to family caregivers. Objective: This study aimed to conduct a scoping review to contribute to the understanding of the types and characteristics of OSGs for family caregivers. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines, the CINAHL, PsychInfo, Psych Articles, Social Sciences, Communication Source, Medline, and Web of Science databases were searched for studies (caregiver focused, adults aged 18 years or older, online social support groups, caring for a living person, peer-reviewed journal publications on empirical research). In total, 19 studies were included in the review. The research questions were (1) what type of social support groups are online for adult family caregivers, (2) what the communication mediums and characteristics of these OSGs are, and (3) what psychosocial or other factors make OSGs successful or unsuccessful for participants. Results: In response to the first research question, we found that the majority of OSGs took place on public text-based forums and were illness specific. Where demographics were reported, participants were predominately women, White, and working with university-level education. There were a variety of caregiving relationships. For the second research question, the most common communication medium found was text-based communication, with the use of emojis, photos, and GIF (Graphics Interchange Format) files as part of these exchanges. Most frequently, the OSGs were asynchronous with a degree of anonymity, not time-limited by the frequency of contact or duration, and moderated by peer or professional moderators or facilitators. Results for the third research question explored the overarching categories of safe communication and engagement and group management. These described successful OSGs as having a focus on similar others with shared lived experiences communicated in a nonjudgmental space overseen by trained peer or professional facilitators. Conclusions: There are several key considerations for OSGs to be successful for family caregivers. A general recommendation for practitioners is to give importance to building active moderation and multifaceted structures of support to meet different levels of caregiver needs and the ability to engage. %M 38090796 %R 10.2196/46858 %U https://www.jmir.org/2023/1/e46858 %U https://doi.org/10.2196/46858 %U http://www.ncbi.nlm.nih.gov/pubmed/38090796 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e50636 %T The Effects of a Digital, Transdiagnostic, Clinically and Peer-Moderated Treatment Platform for Young People With Emerging Mental Health Complaints: Repeated Measures Within-Subjects Study %A van Doorn,Marilon %A Monsanto,Anne %A Wang,Chen Lu %A Verfaillie,Sander C J %A van Amelsvoort,Thérèse A M J %A Popma,Arne %A Jaspers,Monique W M %A Öry,Ferko %A Alvarez-Jimenez,Mario %A Gleeson,John F %A Nieman,Dorien H %+ Amsterdam University Medical Centers (Location AMC), 5 Meibergdreef 9, Amsterdam, 1105AZ, Netherlands, 31 208913747, m.vandoorn@amsterdamumc.nl %K indicative prevention %K youth mental health %K Moderated Online Social Therapy %K MOST+ %K eHealth %K well-being %K early detection and intervention %K Engage Young People Early %K ENYOY %D 2023 %7 13.12.2023 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: To address the growing prevalence of youth mental health problems, early intervention is crucial to minimize individual, societal, and economic impacts. Indicative prevention aims to target emerging mental health complaints before the onset of a full-blown disorder. When intervening at this early stage, individuals are more responsive to treatment, resulting in cost-effective outcomes. The Moderated Online Social Therapy platform, which was successfully implemented and proven effective in Australia, is a digital, peer- and clinically moderated treatment platform designed for young people. The Netherlands was the first country outside Australia to implement this platform, under the name Engage Young People Early (ENYOY). It has the potential to reduce the likelihood of young people developing serious mental health disorders. Objective: This study aims to investigate the effects on young people using the ENYOY-platform in relation to psychological distress, psychosocial functioning, and positive health parameters. Methods: Dutch-speaking young people with emerging mental health complaints (N=131) participated in the ENYOY-platform for 6 months in a repeated measures within-subjects study. Psychological distress, psychosocial functioning, and positive health parameters were assessed at baseline and 3, 6, and 12 months. Repeated measures ANOVA was conducted and adjusted for age, sex, therapy, and community activity. The Reliable Change Index and Clinically Significant Index were computed to compare the baseline with the 6- and 12-month measurements. The missing data rate was 22.54% and the dropout rate 62.6% (82/131). Results: The primary analysis (77/131, 58.8%) showed that psychological distress decreased and psychosocial functioning improved over time with large effect sizes (P<.001 in both cases; ηp2=0.239 and 0.318, respectively) independent of age (P=.76 for psychological distress and P=.48 for psychosocial functioning), sex (P=.24 and P=.88, respectively), therapy activity (P=.49 and P=.80, respectively), or community activity (P=.59 and P=.48, respectively). Similarly, secondary analyses (51/131, 38.9%) showed significant effects of time on the quality of life, well-being, and meaningfulness positive health parameters (P<.05; ηp2=0.062, 0.140, and 0.121, respectively). Improvements in all outcome measures were found between baseline and 3 and 6 months (P≤.001-.01; d=0.23-0.62) and sustained at follow-up (P=.18-.97; d=0.01-0.16). The Reliable Change Index indicated psychological distress improvements in 38% (39/102) of cases, no change in 54.9% (56/102) of cases, and worsening in 5.9% (6/102) of cases. Regarding psychosocial functioning, the percentages were 50% (51/102), 43.1% (44/102), and 6.9% (7/102), respectively. The Clinically Significant Index demonstrated clinically significant changes in 75.5% (77/102) of cases for distress and 89.2% (91/102) for functioning. Conclusions: This trial demonstrated that the ENYOY-platform holds promise as a transdiagnostic intervention for addressing emerging mental health complaints among young people in the Netherlands and laid the groundwork for further clinical research. It would be of great relevance to expand the population on and service delivery of the platform. International Registered Report Identifier (IRRID): RR2-10.1186/s12888-021-03315-x %M 38090802 %R 10.2196/50636 %U https://mhealth.jmir.org/2023/1/e50636 %U https://doi.org/10.2196/50636 %U http://www.ncbi.nlm.nih.gov/pubmed/38090802 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e48689 %T Exposure Versus Cognitive Restructuring Techniques in Brief Internet-Based Cognitive Behavioral Treatment for Arabic-Speaking People With Posttraumatic Stress Disorder: Randomized Clinical Trial %A Stein,Jana %A Vöhringer,Max %A Wagner,Birgit %A Stammel,Nadine %A Nesterko,Yuriy %A Böttche,Maria %A Knaevelsrud,Christine %+ Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Schloßstr. 1, Berlin, 12163, Germany, 49 30 303906 76, j.stein@ueberleben.org %K posttraumatic stress %K posttraumatic stress disorder %K PTSD %K Middle East %K North Africa %K Arabic %K Arabic-speaking people %K internet %K internet-based %K exposure %K cognitive restructuring %K randomized clinical trial %K RCT %K cognitive behavioral therapy %K CBT %K cognitive behavioral treatment %D 2023 %7 13.12.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Cognitive behavioral interventions delivered via the internet are demonstrably efficacious treatment options for posttraumatic stress disorder (PTSD) in underserved, Arabic-speaking populations. However, the role of specific treatment components remains unclear, particularly in conflict-affected areas of the Middle East and North Africa. Objective: This study aims to evaluate 2 brief internet-based treatments in terms of efficacy, including change in PTSD symptom severity during treatment. Both treatments were developed in line with Interapy, an internet-based, therapist-assisted cognitive behavioral therapy protocol for PTSD and adapted to the specific research question. The first treatment comprised self-confrontation and social sharing (exposure treatment; 6 sessions); the second comprised cognitive restructuring and social sharing (cognitive restructuring treatment; 6 sessions). The 2 treatments were compared with each other and with a waitlist control group. Methods: In total, 365 Arabic-speaking participants from the Middle East and North Africa (mean age 25.49, SD 6.68 y) with PTSD were allocated to cognitive restructuring treatment (n=118, 32.3%), exposure treatment (n=122, 33.4%), or a waitlist control group (n=125, 34.2%) between February 2021 and December 2022. PTSD symptom severity, posttraumatic maladaptive cognitions, anxiety, depressive and somatoform symptom severity, and quality of life were assessed via self-report at baseline and after treatment or waiting time. PTSD symptom severity was also measured throughout treatment or waiting time. Treatment satisfaction was assessed after treatment completion. Treatment use and satisfaction were compared between the 2 treatment conditions using appropriate statistical tests (eg, chi-square and Welch tests). Multiple imputation was performed to address missing data and evaluate treatment-associated changes. These changes were analyzed using multigroup change modeling in the completer and intention-to-treat samples. Results: Overall, 200 (N=240, 83.3%) participants started any of the treatments, of whom 123 (61.5%) completed the treatment. Treatment condition was not significantly associated with the proportion of participants who started versus did not start treatment (P=.20) or with treatment completion versus treatment dropout (P=.71). High treatment satisfaction was reported, with no significant differences between the treatment conditions (P=.48). In both treatment conditions, PTSD, anxiety, depressive and somatoform symptom severity, and posttraumatic maladaptive cognitions decreased, and quality of life improved significantly from baseline to the posttreatment time point (P≤.001 in all cases). Compared with the baseline assessment, overall PTSD symptom severity decreased significantly after 4 sessions in both treatment conditions (P<.001). Moreover, both treatment conditions were significantly superior to the waitlist control group regarding overall PTSD symptom severity (P<.001) and most other comorbid mental health symptoms (P<.001 to P=.03). Differences between the 2 conditions in the magnitude of change for all outcome measures were nonsignificant. Conclusions: Internet-based cognitive behavioral treatments for PTSD focusing primarily on either self-confrontation or cognitive restructuring are applicable and efficacious for Arabic-speaking participants. Trial Registration: German Clinical Trials Register DRKS00010245; https://drks.de/search/de/trial/DRKS00010245 %M 38090792 %R 10.2196/48689 %U https://mental.jmir.org/2023/1/e48689 %U https://doi.org/10.2196/48689 %U http://www.ncbi.nlm.nih.gov/pubmed/38090792 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e52398 %T A Christian Faith-Based Facebook Intervention for Smoking Cessation in Rural Communities (FAITH-CORE): Protocol for a Community Participatory Development Study %A Sharma,Pravesh %A Tranby,Brianna %A Kamath,Celia %A Brockman,Tabetha %A Roche,Anne %A Hammond,Christopher %A Brewer,LaPrincess C %A Sinicrope,Pamela %A Lenhart,Ned %A Quade,Brian %A Abuan,Nate %A Halom,Martin %A Staples,Jamie %A Patten,Christi %+ Psychiatry and Psychology, Mayo Clinic Health System, Mayo Clinic, 1221 Whipple St, Eau Claire, WI, 54703, United States, 1 7158385369, sharma.pravesh@mayo.edu %K community %K participatory %K community-based participatory research %K faith %K smoking cessation %K Facebook %K social media %K mobile phone %D 2023 %7 13.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Tobacco smoking remains the leading cause of preventable morbidity and mortality in the United States, with significant rural-urban disparities. Adults who live in rural areas of the United States have among the highest tobacco smoking rates in the nation and experience a higher prevalence of smoking-related deaths and deaths due to chronic diseases for which smoking is a causal risk factor. Barriers to accessing tobacco use cessation treatments are a major contributing factor to these disparities. Adults living in rural areas experience difficulty accessing tobacco cessation services due to geographical challenges, lack of insurance coverage, and lack of health care providers who treat tobacco use disorders. The use of digital technology could be a practical answer to these barriers. Objective: This report describes a protocol for a study whose main objectives are to develop and beta test an innovative intervention that uses a private, moderated Facebook group platform to deliver peer support and faith-based cessation messaging to enhance the reach and uptake of existing evidence-based smoking cessation treatment (EBCT) resources (eg, state quitline coaching programs) for rural adults who smoke. Methods: We will use the Integrated Theory of Health Behavior Change, surface or deep structure frameworks to guide intervention development, and the community-based participatory research (CBPR) approach to identify and engage with community stakeholders. The initial content library of moderator postings (videos and text or image postings) will be developed using existing EBCT material from the Centers for Disease Control and Prevention Tips from Former Smokers Campaign. The content library will feature topics related to quitting smoking, such as coping with cravings and withdrawal and using EBCTs with faith-based message integration (eg, Bible quotes). A community advisory board and a community engagement studio will provide feedback to refine the content library. We will also conduct a beta test of the intervention with 15 rural adults who smoke to assess the recruitment feasibility and preliminary intervention uptake such as engagement, ease of use, usefulness, and satisfaction to further refine the intervention based on participant feedback. Results: The result of this study will create an intervention prototype that will be used for a future randomized controlled trial. Conclusions: Our CBPR project will create a prototype of a Facebook-delivered faith-based messaging and peer support intervention that may assist rural adults who smoke to use EBCT. This study is crucial in establishing a self-sufficient smoking cessation program for the rural community. The project is unique in using a moderated social media platform providing peer support and culturally relevant faith-based content to encourage adult people who smoke to seek treatment and quit smoking. International Registered Report Identifier (IRRID): PRR1-10.2196/52398 %M 38090799 %R 10.2196/52398 %U https://www.researchprotocols.org/2023/1/e52398 %U https://doi.org/10.2196/52398 %U http://www.ncbi.nlm.nih.gov/pubmed/38090799 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e48677 %T An Online Psychological Program for Adolescents and Young Adults With Headaches: Iterative Design and Rapid Usability Testing %A Huguet,Anna %A Rozario,Sharlene %A Wozney,Lori %A McGrath,Patrick J %+ Department of Psychology, Universitat Rovira i Virgili, Carretera de Valls, s/n, Tarragona, 43007, Spain, 34 977 55 80 96, anna.huguet@urv.cat %K adolescents %K cognitive-behavioral intervention %K design process %K end users %K headaches %K internet %K usability %K young adult %D 2023 %7 12.12.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Headache disorders are common, debilitating health problems. Cognitive-behavioral therapy (CBT) is recommended but rarely easily available. With the use of the internet and communication technologies among youth and young adults, these individuals could be self-trained in CBT skills. There is an increasing number of internet-based interventions for headaches, but there has been little research into the usability of these interventions because evaluating usability across the intervention development life cycle is costly. We developed an internet-based CBT program, the Specialized Program for Headache Reduction (SPHERE). While developing it, we aimed to improve SPHERE through rapid usability testing cycles. Objective: This study aims to presents a rapid and affordable usability testing approach that can be performed throughout the intervention development life cycle. This paper also provides evidence of the usability of SPHERE. Methods: We used the “think aloud” usability testing method based on Krug’s approach to test user interaction within a lab setting. This was followed by a short posttest interview. We planned to test SPHERE with 3-5 participants testing the same part of the program each cycle. Both the design and development team and the research team actively participated in the usability testing process. Observers independently identified the top 3 usability issues, rated their severity, and conducted debriefing sessions to come to consensus on major issues and generate potential solutions. Results: The testing process allowed major usability issues to be identified and rectified rapidly before piloting SPHERE in a real-world context. A total of 2 cycles of testing were conducted. Of the usability issues encountered in cycles 1 and 2, a total of 68% (17/25) and 32% (12/38), respectively, were rated as major, discussed, and fixed. Conclusions: This study shows that rapid usability testing is an essential part of the design process that improves program functionality and can be easy and inexpensive to undertake. %M 38085567 %R 10.2196/48677 %U https://humanfactors.jmir.org/2023/1/e48677 %U https://doi.org/10.2196/48677 %U http://www.ncbi.nlm.nih.gov/pubmed/38085567 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e46678 %T Optimizing Digital Tools for the Field of Substance Use and Substance Use Disorders: Backcasting Exercise %A Scheibein,Florian %A Caballeria,Elsa %A Taher,Md Abu %A Arya,Sidharth %A Bancroft,Angus %A Dannatt,Lisa %A De Kock,Charlotte %A Chaudhary,Nazish Idrees %A Gayo,Roberto Perez %A Ghosh,Abhishek %A Gelberg,Lillian %A Goos,Cees %A Gordon,Rebecca %A Gual,Antoni %A Hill,Penelope %A Jeziorska,Iga %A Kurcevič,Eliza %A Lakhov,Aleksey %A Maharjan,Ishwor %A Matrai,Silvia %A Morgan,Nirvana %A Paraskevopoulos,Ilias %A Puharić,Zrinka %A Sibeko,Goodman %A Stola,Jan %A Tiburcio,Marcela %A Tay Wee Teck,Joseph %A Tsereteli,Zaza %A López-Pelayo,Hugo %+ Health and Addictions Research Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Calle Rosselló, 149-153, Barcelona, 08036, Spain, 34 932275400 ext 4160, caballeria@recerca.clinic.cat %K substance use %K substance use disorders %K addictions %K telemedicine %K eHealth %K digital tools %K backcasting exercise %K drug addiction %K ethical frameworks %K digital health %D 2023 %7 12.12.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Substance use trends are complex; they often rapidly evolve and necessitate an intersectional approach in research, service, and policy making. Current and emerging digital tools related to substance use are promising but also create a range of challenges and opportunities. Objective: This paper reports on a backcasting exercise aimed at the development of a roadmap that identifies values, challenges, facilitators, and milestones to achieve optimal use of digital tools in the substance use field by 2030. Methods: A backcasting exercise method was adopted, wherein the core elements are identifying key values, challenges, facilitators, milestones, cornerstones and a current, desired, and future scenario. A structured approach was used by means of (1) an Open Science Framework page as a web-based collaborative working space and (2) key stakeholders’ collaborative engagement during the 2022 Lisbon Addiction Conference. Results: The identified key values were digital rights, evidence-based tools, user-friendliness, accessibility and availability, and person-centeredness. The key challenges identified were ethical funding, regulations, commercialization, best practice models, digital literacy, and access or reach. The key facilitators identified were scientific research, interoperable infrastructure and a culture of innovation, expertise, ethical funding, user-friendly designs, and digital rights and regulations. A range of milestones were identified. The overarching identified cornerstones consisted of creating ethical frameworks, increasing access to digital tools, and continuous trend analysis. Conclusions: The use of digital tools in the field of substance use is linked to a range of risks and opportunities that need to be managed. The current trajectories of the use of such tools are heavily influenced by large multinational for-profit companies with relatively little involvement of key stakeholders such as people who use drugs, service providers, and researchers. The current funding models are problematic and lack the necessary flexibility associated with best practice business approaches such as lean and agile principles to design and execute customer discovery methods. Accessibility and availability, digital rights, user-friendly design, and person-focused approaches should be at the forefront in the further development of digital tools. Global legislative and technical infrastructures by means of a global action plan and strategy are necessary and should include ethical frameworks, accessibility of digital tools for substance use, and continuous trend analysis as cornerstones. %M 38085569 %R 10.2196/46678 %U https://humanfactors.jmir.org/2023/1/e46678 %U https://doi.org/10.2196/46678 %U http://www.ncbi.nlm.nih.gov/pubmed/38085569 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44768 %T Safety Evaluation in Iterative Development of Wearable Patches for Aripiprazole Tablets With Sensor: Pooled Analysis of Clinical Trials %A Jan,Michael %A Coppin-Renz,Antonia %A West,Robin %A Gallo,Christophe Le %A Cochran,Jeffrey M %A Heumen,Emiel van %A Fahmy,Michael %A Reuteman-Fowler,J Corey %+ Otsuka Pharma GmbH, Europa-Allee 52, Frankfurt am Main, 60327, Germany, 49 (0)151 6468280, acoppinrenz@otsuka-europe.com %K wearable sensor %K adhesive patch %K adverse events %K skin irritation %K product iteration %K mobile phone %K biocompatibility %K Abilify MyCite %K development %K sensors %K skin %K monitoring %K treatment %K schizophrenia %K bipolar disorder %K depressive disorder %K abrasions %K blisters %K dermatitis %K pain %K rash %D 2023 %7 12.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Wearable sensors in digital health may pose a risk for skin irritation through the use of wearable patches. Little is known about how patient- and product-related factors impact the risk of skin irritation. Aripiprazole tablets with sensor (AS, Abilify MyCite; Otsuka America Pharmaceutical, Inc) is a digital medicine system indicated for the treatment of patients with schizophrenia, bipolar I disorder, and major depressive disorder. AS includes aripiprazole tablets with an embedded ingestible event marker, a wearable sensor attached to the skin through a wearable patch, a smartphone app, and a web-based portal. To continuously improve the final product, successive iterations of wearable patches were developed, including raisin patch version 4 (RP4), followed by disposable wearable sensor version 5 (DW5), and then reusable wearable sensor version 2 (RW2). Objective: This analysis pooled safety data from clinical studies in adult participants using the RP4, DW5, and RW2 wearable patches of AS and evaluated adverse events related to the use of wearable patches. Methods: Safety data from 12 studies in adults aged 18-65 years from May 2010 to August 2020 were analyzed. All studies evaluated safety, with studies less than 2 weeks also specifically examining human factors associated with the use of the components of AS. Healthy volunteers or patients with schizophrenia, bipolar I disorder, or major depressive disorder were enrolled; those who were exposed to at least 1 wearable patch were included in the safety analysis. Adverse events related to the use of a wearable patch were evaluated. Abrasions, blisters, dermatitis, discoloration, erythema, irritation, pain, pruritus, rash, and skin reactions were grouped as skin irritation events (SIEs). All statistical analyses were descriptive. Results: The analysis included 763 participants (mean [SD] age 42.6 [12.9] years; White: n=359, 47.1%; and male: n=420, 55%). Participants were healthy volunteers (n=269, 35.3%) or patients with schizophrenia (n=402, 52.7%), bipolar I disorder (n=57, 7.5%), or major depressive disorder (n=35, 4.6%). Overall, 13.6% (104/763) of the participants reported at least 1 SIE, all of which were localized to the wearable patch site. Incidence of ≥1 patch-related SIEs was seen in 18.1% (28/155), 14.2% (55/387), and 9.2% (28/306) of participants who used RP4, DW5, and RW2, respectively. Incidence of SIE-related treatment discontinuation was low, which is reported by 1.9% (3/155), 3.1% (12/387), and 1.3% (4/306) of participants who used RP4, DW5, and RW2, respectively. Conclusions: The incidence rates of SIEs reported as the wearable patch versions evolved from RP4 through RW2 suggest that information derived from reported adverse events may have informed product design and development, which could have improved both tolerability and wearability of successive products. Trial Registration: Clinicaltrials.gov NCT02091882, https://clinicaltrials.gov/study/NCT02091882; Clinicaltrials.gov NCT02404532, https://clinicaltrials.gov/study/NCT02404532; Clinicaltrials.gov NCT02722967, https://clinicaltrials.gov/study/NCT02722967; Clinicaltrials.gov NCT02219009, https://clinicaltrials.gov/study/NCT02219009; Clinicaltrials.gov NCT03568500, https://clinicaltrials.gov/study/NCT03568500; Clinicaltrials.gov NCT03892889, https://clinicaltrials.gov/study/NCT03892889 %M 38085556 %R 10.2196/44768 %U https://formative.jmir.org/2023/1/e44768 %U https://doi.org/10.2196/44768 %U http://www.ncbi.nlm.nih.gov/pubmed/38085556 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e52088 %T Evaluating the Clinical Use and Utility of a Digital Support App for Employees With Chronic Pain Returning to Work (SWEPPE): Observational Study %A Turesson,Christina %A Liedberg,Gunilla %A Björk,Mathilda %+ Division of Prevention, Rehabilitation and Community Medicine, Department of Health, Medicine and Caring Sciences, Linköping University, Kåkenhus, Bredgatan 32, Linköping, 581 85, Sweden, 46 11363602, christina.turesson@liu.se %K chronic pain %K digital support %K eHealth %K return-to-work %K user data %K mobile phone %D 2023 %7 11.12.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: The digital app SWEPPE (sustainable worker, a digital support for persons with chronic pain and their employers) was developed to improve the support of people with chronic pain in their return-to-work process after sick leave and includes functions such as the action plan, daily self-rating, self-monitoring graphs, the coach, the library, and shared information with the employer. Objective: This study aims to describe the use of the smartphone app SWEPPE among people with chronic pain who have participated in an interdisciplinary pain rehabilitation program. Methods: This is a case study including 16 people participating in a feasibility study. The analyses were based on user data collected for 3 months. Quantitative data regarding used functions were analyzed with descriptive statistics, and qualitative data of identified needs of support from the employer were grouped into 8 categories. Results: Self-monitoring was used by all participants (median 26, IQR 8-87 daily registrations). A total of 11 (N=16, 69%) participants set a work-related goal and performed weekly evaluations of goal fulfillment and ratings of their work ability. In total, 9 (56%) participants shared information with their employer and 2 contacted the coach. A total of 15 (94%) participants identified a total of 51 support interventions from their employer. Support to adapt to work assignments and support to adapt to work posture were the 2 biggest categories. The most common type of support identified by 53% (8/15) of the participants was the opportunity to take breaks and short rests. Conclusions: Participants used multiple SWEPPE functions, such as daily self-registration, goal setting, self-monitoring, and employer support identification. This shows the flexible nature of SWEPPE, enabling individuals to select functions that align with their needs. Additional research is required to investigate the extended use of SWEPPE and how employers use shared employee information. %M 38079212 %R 10.2196/52088 %U https://humanfactors.jmir.org/2023/1/e52088 %U https://doi.org/10.2196/52088 %U http://www.ncbi.nlm.nih.gov/pubmed/38079212 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e50579 %T Effect of a Medication Adherence Mobile Phone App on Medically Underserved Patients with Chronic Illness: Preliminary Efficacy Study %A Hartch,Christa E %A Dietrich,Mary S %A Stolldorf,Deonni P %+ School of Nursing and Health Sciences, Manhattanville College, 2900 Purchase Street, Purchase, NY, 10577, United States, 1 914 323 5365, christa.hartch@mville.edu %K medication adherence %K medication self-efficacy %K mobile phone applications %K medically underserved populations %K mHealth %K mobile health %K app %K apps %K applications %K underserved %K adherence %K survey %K surveys %K chronic illness %D 2023 %7 11.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Medication adherence is vital in the treatment of patients with chronic illness who require long-term medication therapies to maintain optimal health. Medication adherence, a complex and widespread problem, has been difficult to solve. Additionally, lower-income, medically underserved communities have been found to have higher rates of inadequate adherence to oral medications. Even so, this population has been underrepresented in studies using mobile medication adherence app interventions. Federally qualified health centers provide care for medically underserved populations, defined as communities and populations where there is a demonstrable unmet need for health services. These centers have been reporting an increase in a more complex chronic disease population. Including medically underserved individuals in mobile health studies provides opportunities to support this disproportionately affected group, work toward reducing health disparities in access to health care, and understand barriers to mobile health uptake. Objective: The aim of this preliminary efficacy study was to evaluate the effects and feasibility of a commercially available medication adherence app, Medisafe, in a medically underserved adult population with various chronic illnesses seeking care in a federally qualified health center. Methods: Participants in this single-arm pre-post intervention preliminary efficacy study (N=10) completed a baseline survey, used the app for 2 weeks, and completed an end-of-study survey. The primary outcome measures were medication adherence and medication self-efficacy. Feedback on the use of the app was also gathered. Results: A statistically significant median increase of 8 points on the self-efficacy for adherence to medications scale was observed (P=.03, Cohen d=0.69). Though not significant, the adherence to refills and medications scale demonstrated a median change of 2.5 points in the direction of increased medication adherence (P=.21, Cohen d=0.41). Feedback about the app was positive. Conclusions: Use of the Medisafe app is a viable option to improve medication self-efficacy and medication adherence in medically underserved patients in an outpatient setting with a variety of chronic illnesses. %M 38079192 %R 10.2196/50579 %U https://formative.jmir.org/2023/1/e50579 %U https://doi.org/10.2196/50579 %U http://www.ncbi.nlm.nih.gov/pubmed/38079192 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e49179 %T Developing Message Strategies to Engage Racial and Ethnic Minority Groups in Digital Oral Self-Care Interventions: Participatory Co-Design Approach %A Carpenter,Stephanie M %A Greer,Zara M %A Newman,Rebecca %A Murphy,Susan A %A Shetty,Vivek %A Nahum-Shani,Inbal %+ College of Health Solutions, Arizona State University, 425 N 5th St, Phoenix, AZ, 85004, United States, 1 480 727 5740, Stephanie.M.Carpenter@asu.edu %K engagement %K oral health %K mobile health intervention %K mHealth intervention %K formative %K racial and ethnic minority group %K digital health %K mobile health %K mHealth %K message development %K health equity %K racial minority %K ethnic minority %K digital intervention %K dental care %K barrier %K oral self-care %K mobile phone %D 2023 %7 11.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The prevention of oral health diseases is a key public health issue and a major challenge for racial and ethnic minority groups, who often face barriers in accessing dental care. Daily toothbrushing is an important self-care behavior necessary for sustaining good oral health, yet engagement in regular brushing remains a challenge. Identifying strategies to promote engagement in regular oral self-care behaviors among populations at risk of poor oral health is critical. Objective: The formative research described here focused on creating messages for a digital oral self-care intervention targeting a racially and ethnically diverse population. Theoretically grounded strategies (reciprocity, reciprocity-by-proxy, and curiosity) were used to promote engagement in 3 aspects: oral self-care behaviors, an oral care smartphone app, and digital messages. A web-based participatory co-design approach was used to develop messages that are resource efficient, appealing, and novel; this approach involved dental experts, individuals from the general population, and individuals from the target population—dental patients from predominantly low-income racial and ethnic minority groups. Given that many individuals from racially and ethnically diverse populations face anonymity and confidentiality concerns when participating in research, we used an approach to message development that aimed to mitigate these concerns. Methods: Messages were initially developed with feedback from dental experts and Amazon Mechanical Turk workers. Dental patients were then recruited for 2 facilitator-mediated group webinar sessions held over Zoom (Zoom Video Communications; session 1: n=13; session 2: n=7), in which they provided both quantitative ratings and qualitative feedback on the messages. Participants interacted with the facilitator through Zoom polls and a chat window that was anonymous to other participants. Participants did not directly interact with each other, and the facilitator mediated sessions by verbally asking for message feedback and sharing key suggestions with the group for additional feedback. This approach plausibly enhanced participant anonymity and confidentiality during the sessions. Results: Participants rated messages highly in terms of liking (overall rating: mean 2.63, SD 0.58; reciprocity: mean 2.65, SD 0.52; reciprocity-by-proxy: mean 2.58, SD 0.53; curiosity involving interactive oral health questions and answers: mean 2.45, SD 0.69; curiosity involving tailored brushing feedback: mean 2.77, SD 0.48) on a scale ranging from 1 (do not like it) to 3 (like it). Qualitative feedback indicated that the participants preferred messages that were straightforward, enthusiastic, conversational, relatable, and authentic. Conclusions: This formative research has the potential to guide the design of messages for future digital health behavioral interventions targeting individuals from diverse racial and ethnic populations. Insights emphasize the importance of identifying key stimuli and tasks that require engagement, gathering multiple perspectives during message development, and using new approaches for collecting both quantitative and qualitative data while mitigating anonymity and confidentiality concerns. %M 38079204 %R 10.2196/49179 %U https://formative.jmir.org/2023/1/e49179 %U https://doi.org/10.2196/49179 %U http://www.ncbi.nlm.nih.gov/pubmed/38079204 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e53556 %T AI Conversational Agent to Improve Varenicline Adherence: Protocol for a Mixed Methods Feasibility Study %A Minian,Nadia %A Mehra,Kamna %A Earle,Mackenzie %A Hafuth,Sowsan %A Ting-A-Kee,Ryan %A Rose,Jonathan %A Veldhuizen,Scott %A Zawertailo,Laurie %A Ratto,Matt %A Melamed,Osnat C %A Selby,Peter %+ INTREPID Lab, Centre for Addiction and Mental Health, 1025 Queen Street West, Toronto, ON, M6J1H1, Canada, 1 4165358501 ext 77420, nadia.minian2@camh.ca %K evaluation %K health bot %K medication adherence %K smoking cessation %K varenicline %K artificial intelligence %K AI %D 2023 %7 11.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Varenicline is a pharmacological intervention for tobacco dependence that is safe and effective in facilitating smoking cessation. Enhanced adherence to varenicline augments the probability of prolonged smoking abstinence. However, research has shown that one-third of people who use varenicline are nonadherent by the second week. There is evidence showing that behavioral support helps with medication adherence. We have designed an artificial intelligence (AI) conversational agent or health bot, called “ChatV,” based on evidence of what works as well as what varenicline is, that can provide these supports. ChatV is an evidence-based, patient- and health care provider–informed health bot to improve adherence to varenicline. ChatV has been programmed to provide medication reminders, answer questions about varenicline and smoking cessation, and track medication intake and the number of cigarettes. Objective: This study aims to explore the feasibility of the ChatV health bot, to examine if it is used as intended, and to determine the appropriateness of proceeding with a randomized controlled trial. Methods: We will conduct a mixed methods feasibility study where we will pilot-test ChatV with 40 participants. Participants will be provided with a standard 12-week varenicline regimen and access to ChatV. Passive data collection will include adoption measures (how often participants use the chatbot, what features they used, when did they use it, etc). In addition, participants will complete questionnaires (at 1, 4, 8, and 12 weeks) assessing self-reported smoking status and varenicline adherence, as well as questions regarding the acceptability, appropriateness, and usability of the chatbot, and participate in an interview assessing acceptability, appropriateness, fidelity, and adoption. We will use “stop, amend, and go” progression criteria for pilot studies to decide if a randomized controlled trial is a reasonable next step and what modifications are required. A health equity lens will be adopted during participant recruitment and data analysis to understand and address the differences in uptake and use of this digital health solution among diverse sociodemographic groups. The taxonomy of implementation outcomes will be used to assess feasibility, that is, acceptability, appropriateness, fidelity, adoption, and usability. In addition, medication adherence and smoking cessation will be measured to assess the preliminary treatment effect. Interview data will be analyzed using the framework analysis method. Results: Participant enrollment for the study will begin in January 2024. Conclusions: By using predetermined progression criteria, the results of this preliminary study will inform the determination of whether to advance toward a larger randomized controlled trial to test the effectiveness of the health bot. Additionally, this study will explore the acceptability, appropriateness, fidelity, adoption, and usability of the health bot. These insights will be instrumental in refining the intervention and the health bot. Trial Registration: ClinicalTrials.gov NCT05997901; https://classic.clinicaltrials.gov/ct2/show/NCT05997901 International Registered Report Identifier (IRRID): PRR1-10.2196/53556 %M 38079201 %R 10.2196/53556 %U https://www.researchprotocols.org/2023/1/e53556 %U https://doi.org/10.2196/53556 %U http://www.ncbi.nlm.nih.gov/pubmed/38079201 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e50729 %T Implementation of Remote Activity Sensing to Support a Rehabilitation Aftercare Program: Observational Mixed Methods Study With Patients and Health Care Professionals %A Lu,Ziyuan %A Signer,Tabea %A Sylvester,Ramona %A Gonzenbach,Roman %A von Wyl,Viktor %A Haag,Christina %+ Institute for Implementation Science in Health Care, University of Zurich, Universitätstrasse 84, Zurich, 8006, Switzerland, 41 446346380, viktor.vonwyl@uzh.ch %K physical activity %K activity sensor %K normalization process theory %K rehabilitation %K chronic disease %K chronic %K aftercare %K sensor %K sensors %K exercise %K neurology %K neuroscience %K neurorehabilitation %K adherence %K need %K needs %K experience %K experiences %K questionnaire %K questionnaires %K mobile phone %D 2023 %7 8.12.2023 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Physical activity is central to maintaining the quality of life for patients with complex chronic conditions and is thus at the core of neurorehabilitation. However, maintaining activity improvements in daily life is challenging. The novel Stay With It program aims to promote physical activity after neurorehabilitation by cultivating self-monitoring skills and habits. Objective: We examined the implementation of the Stay With It program at the Valens Rehabilitation Centre in Switzerland using the normalization process theory framework, focusing on 3 research aims. We aimed to examine the challenges and facilitators of program implementation from the perspectives of patients and health care professionals. We aimed to evaluate the potential of activity sensors to support program implementation and patient acceptance. Finally, we aimed to evaluate patients’ engagement in physical activity after rehabilitation, patients’ self-reported achievement of home activity goals, and factors influencing physical activity. Methods: Patients were enrolled if they had a disease that was either chronic or at risk for chronicity and participated in the Stay With It program. Patients were assessed at baseline, the end of rehabilitation, and a 3-month follow-up. The health care professionals designated to deliver the program were surveyed before and after program implementation. We used a mixed methods approach combining standardized questionnaires, activity-sensing data (patients only), and free-text questions. Results: This study included 23 patients and 13 health care professionals. The diverse needs of patients and organizational hurdles were major challenges to program implementation. Patients’ intrinsic motivation and health care professionals’ commitment to refining the program emerged as key facilitators. Both groups recognized the value of activity sensors in supporting program implementation and sustainability. Although patients appreciated the sensor’s ability to monitor, motivate, and quantify activity, health care professionals saw the sensor as a motivational tool but expressed concerns about technical difficulties and potential inaccuracies. Physical activity levels after patients returned home varied considerably, both within and between individuals. The self-reported achievement of activity goals at home also varied, in part because of vague definitions. Common barriers to maintaining activity at home were declining health and fatigue often resulting from heat and pain. At the 3-month follow-up, 35% (8/23) of the patients withdrew from the study, with most citing deteriorating physical health as the reason and that monitoring and discussing their low activity would negatively affect their mental health. Conclusions: Integrating aftercare programs like Stay With It into routine care is vital for maintaining physical activity postrehabilitation. Although activity trackers show promise in promoting motivation through monitoring, they may lead to frustration during health declines. Their acceptability may also be influenced by an individual’s health status, habits, and technical skills. Our study highlights the importance of considering health care professionals’ perspectives when integrating new interventions into routine care. %M 38064263 %R 10.2196/50729 %U https://mhealth.jmir.org/2023/1/e50729 %U https://doi.org/10.2196/50729 %U http://www.ncbi.nlm.nih.gov/pubmed/38064263 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e51277 %T Secure Messaging Intervention in Patients Starting New Antidepressant to Promote Adherence: Pilot Randomized Controlled Trial %A Turvey,Carolyn %A Fuhrmeister,Lindsey %A Klein,Dawn %A McCoy,Kimberly %A Moeckli,Jane %A Stewart Steffensmeier,Kenda R %A Suiter,Natalie %A Van Tiem,Jen %+ Center for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, 601 Highway 6 West, Iowa City, IA, 52246, United States, 1 3193216799, Carolyn.Turvey@va.gov %K depression %K text messaging %K medication adherence %K medication %K medications %K adherence %K antidepressant %K antidepressants %K depressive %K text message %K text messages %K messaging %K SMS %K veteran %K veterans %K military %K randomized controlled trial %K RCT %K controlled trials %K mental health %K psychiatry %K mobile phone %D 2023 %7 8.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: There are a range of effective pharmacological and behavioral treatments for depression. However, approximately one-third of patients discontinue antidepressants within the first month of treatment and 44% discontinue them by the third month of treatment. The major reasons reported for discontinuation were side effect burden, patients experiencing that the medications were not working, and patients wanting to resolve their depression without using medication. Objective: This study tested the acceptability, feasibility, and preliminary effectiveness of an SMS messaging intervention designed to improve antidepressant adherence and depression outcomes in veterans. The intervention specifically targeted the key reasons for antidepressant discontinuation. For example, the secure message included reminders that it can take up to 6 weeks for an antidepressant to work, or prompts to call their provider should the side effect burden become significant. Methods: This pilot was a 3-armed randomized controlled trial of 53 veterans undergoing depression treatment at the Iowa City Veterans Affairs Health Care System. Veterans starting a new antidepressant were randomized to secure messaging only (SM-Only), secure messaging with coaching (SM+Coach), or attention control (AC) groups. The intervention lasted 12 weeks with follow-up assessments of key outcomes at 6 and 12-weeks. This included a measure of antidepressant adherence, depressive symptom severity, and side effect burden. Results: The 2 active interventions (SM-Only and SM+Coach) demonstrated small to moderate effect sizes (ESs) in improving antidepressant adherence and reducing side effect burden. They did not appear to reduce the depressive symptom burden any more than in the AC arm. Veteran participants in the SM arms demonstrated improved medication adherence from baseline to 12 weeks on the Medication Adherence Rating Scale compared with those in the AC arm, who had a decline in adherence (SM-Only: ES=0.09; P=.19; SM+Coach: ES=0.85; P=.002). Depression scores on the 9-Item Patient Health Questionnaire decreased for all 3 treatment arms, although the decline was slightly larger for the SM-Only (ES=0.32) and the SM+Coach (ES=0.24) arms when compared with the AC arm. The 2 intervention arms indicated a decrease in side effects on the Frequency, Intensity, and Burden of Side Effects Ratings, whereas the side effect burden for the AC arm increased. These differences indicated moderate ES (SM-Only vs AC: ES=0.40; P=.07; SM+Coach: ES=0.54; P=.07). Conclusions: A secure messaging program targeting specific reasons for antidepressant discontinuation had small-to-moderate ES in improving medication adherence. Consistent with prior research, the intervention that included brief synchronic meetings with a coach appeared to have a greater benefit than the SMS-alone intervention. Veterans consistently engaged with the SMS messaging in both treatment arms throughout the study period. They additionally provided feedback on which texts were most helpful, tending to prefer messages providing overall encouragement rather than specific wellness recommendations. Trial Registration: ClinicalTrials.gov NCT03930849; https://clinicaltrials.gov/study/NCT03930849 %M 38064267 %R 10.2196/51277 %U https://formative.jmir.org/2023/1/e51277 %U https://doi.org/10.2196/51277 %U http://www.ncbi.nlm.nih.gov/pubmed/38064267 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e48609 %T A Codeveloped Web-Based Disability Disclosure Toolkit for Youth With Disabilities: Mixed Methods Pilot Evaluation %A Lindsay,Sally %A Kosareva,Polina %A Thomson,Nicole %A Stinson,Jennifer %+ Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Road, Toronto, ON, M4G 1R8, Canada, 1 416 425 6220, slindsay@hollandbloorview.ca %K disability %K disclosure %K employment %K vocational rehabilitation %K youth and young adults %K usability testing %K qualitative %K pilot study %K co-design %D 2023 %7 8.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Youth and young adults with disabilities experience many barriers in securing employment such as discrimination, inaccessible environments, and lack of support. Youth often need to decide whether and how they should disclose their need for accommodations to employers, which can help them to do their best at work. However, few evidence-based toolkits focusing on disability disclosure exist for youth with various types of disabilities. Supporting youth to develop self-advocacy skills is salient because they are an underrepresented and marginalized group in the labor market. Objective: The objective of this study was to conduct a pilot evaluation of a web-based toolkit to enhance disability disclosure for youth and young adults helping to advocate for their needs and request workplace accommodations. Methods: We conducted 2 in-person focus groups to codevelop a web-based disability disclosure toolkit, which was followed by a pilot evaluation with a pre-post survey. Primary outcomes focused on the relevance of the toolkit content, preliminary perceived impact on knowledge and confidence, and open-ended feedback on the usefulness of the toolkit. Secondary outcomes focused on effectiveness (ie, measures of self-determination). Results: A total of 14 youths with various types of disabilities took part in the study (aged 20-25 years; n=11, 78% female) including 3 who participated in the codevelopment focus group sessions and 11 youths who participated in the surveys. Our findings involved three main themes in the codevelopment sessions that included (1) disability disclosure and workplace accommodation experiences (ie, knowing when, whether, and how to disclose their disability and request workplace accommodations), (2) usefulness of the tool (ie, relatable content, format and design, and suggestions for further development), and (3) perceived impact of the toolkit (ie, navigating disclosure decisions and how to approach employers and develop other relevant employment skills). The survey findings showed that the majority of participants (10/11, 91%) reported that the toolkit increased or changed their knowledge or understanding of disability disclosure. Most participants (8/11, 73%) reported that the toolkit helped to increase their perceived confidence in their daily activities. The majority of participants (8/11, 73%) agreed or strongly agreed that the toolkit was easy to understand and comprehensive. Regarding the preliminary impact of the toolkit, participants did not demonstrate any significant improvements in self-determination (all P>.05). Conclusions: Our findings emphasize the importance of codeveloping a disability disclosure toolkit with youth to enhance its relevance for their needs. Our toolkit indicates preliminary potential as an educational resource for youth and young adults with disabilities as they search for and secure employment. Further research is needed to assess the impact of the tool with larger samples to understand the impact of workplace disability disclosure decisions for youth with disabilities. %M 38064264 %R 10.2196/48609 %U https://formative.jmir.org/2023/1/e48609 %U https://doi.org/10.2196/48609 %U http://www.ncbi.nlm.nih.gov/pubmed/38064264 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e48402 %T The Effects of a Parent-Focused Social Media Intervention on Child Sun Safety: Pilot and Feasibility Study %A Manne,Sharon %A Wu,Yelena %A Buller,David %A Heckman,Carolyn %A Devine,Katie %A Frederick,Sara %A Solleder,Justin %A Schaefer,Alexis %A Lu,Shou-En %+ Behavioral Sciences, Rutgers Cancer Institute of New Jersey, Rutgers, The State University of New Jersey, 120 Albany Street Tower II, New Brunswick, NJ, 08901, United States, 1 7323577978, mannesl@cinj.rutgers.edu %K health behavior %K health promotion and prevention %K parenting %K prevention science %K parents %K parent %K Facebook %K social media %K sun %K prevention %K skin %K dermatology %D 2023 %7 8.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Middle childhood (ages 8-12 years) is a critical period for forming behavioral habits and reducing the risk for the development of skin cancer later in life. During this time, children develop more autonomy and spend more unsupervised time away from their parents. Professional agencies recommend that all children engage in regular sun protection behaviors and avoid the sun during peak daytime hours. Unfortunately, in middle childhood, child sun protection often declines and UV radiation exposure increases. Effective parenting involves balancing ways to encourage the child’s increasing independence while providing practical assistance to ensure sun protection is implemented. Objective: The goal was to evaluate the feasibility, acceptability, and preliminary effects of Sun Safe Families, a Facebook group intervention for parents of children between 8 and 12 years of age. Methods: The team developed Facebook messages targeting parent knowledge, normative influences, sun safety barriers, planning and goal setting, confidence in implementing sun safety, communication, forming habits, and managing sun safety in risky situations. A total of 92 parents were enrolled, and the groups ran for 6 weeks. Feasibility was measured by enrollment and retention rates. Acceptability was measured by engagement in the Facebook groups. Satisfaction was assessed by a treatment evaluation. At pre- and post-intervention, parents completed measures of child sun protection, UV radiation exposure, sunburn, sun safety knowledge, child risk, barriers, sun protection self-efficacy, planning, sun safe habits, norms for child sun safety, and communication about sun safety. Results: Enrollment (64.3%, 92/143) and retention (94.6%, 87/92) were good. On average, participants viewed 67.6% (56.8/84) of posts, “liked” 16.4% (13.77/84) of posts, commented on 14.8% (12.43/84) of posts, and voted on 46% (6.4/14) of polls. Satisfaction was excellent. From pre- to post-intervention, there were significant increases in child sun protection, sun exposure, and sunburn (P<.01; moderate effect sizes), as well as statistically significant increases in planning and self-efficacy (P<.05) and family norms and parent communication (P<.01). Conclusions: This study demonstrated high survey retention, acceptability, and satisfaction with the intervention. There were promising preliminary effects on child sun protection behaviors and parent sun protection attitudes and communication with their child. Replication with a larger sample size and a comparison condition is warranted. %M 38064250 %R 10.2196/48402 %U https://formative.jmir.org/2023/1/e48402 %U https://doi.org/10.2196/48402 %U http://www.ncbi.nlm.nih.gov/pubmed/38064250 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43096 %T Strengths and Limitations of Web-Based Cessation Support for Individuals Who Smoke, Dual Use, or Vape: Qualitative Interview Study %A Struik,Laura %A Christianson,Kyla %A Khan,Shaheer %A Sharma,Ramona H %+ School of Nursing, University of British Columbia Okanagan, ART 140, 1147 Research Road, Kelowna, BC, V1V 1V7, Canada, 1 2508647879, laura.struik@ubc.ca %K qualitative research %K tobacco use %K smoking %K vaping %K cessation %K eHealth %K individuals who smoke %K users %K tobacco %K e-cigarettes %K cigarettes %K web-based %K support %K behavioral %K smartphone app %K social media %K mobile phone %D 2023 %7 8.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Tobacco use has shifted in recent years, especially with the introduction of e-cigarettes. Despite the current variable and intersecting tobacco product use among tobacco users, most want to quit, which necessitates cessation programs to adapt to these variable trends (vs focusing on combustible cigarettes alone). The use of web-based modalities for cessation support has become quite popular in recent years and has been compounded by the COVID-19 pandemic. Therefore, understanding the current strengths and limitations of existing programs to meet the needs of current various tobacco users is critical for ensuring the saliency of such programs moving forward. Objective: The purpose of this study was to understand the strengths and limitations of web-based cessation support offered through QuitNow to better understand the needs of a variety of end users who smoke, dual use, or vape. Methods: Semistructured interviews were conducted with 36 nicotine product users in British Columbia. Using conventional content analysis methods, we inductively derived descriptive categories and themes related to the strengths and limitations of QuitNow for those who smoke, dual use, or vape. We analyzed the data with the support of NVivo (version 12; QSR International) and Excel (Microsoft Corporation). Results: Participants described several strengths and limitations of QuitNow and provided suggestions for improvement, which fell under 2 broad categories: look and feel and content and features. Shared strengths included the breadth of information and the credible nature of the website. Individuals who smoke were particularly keen about the site having a nonjudgmental feeling. Moreover, compared with individuals who smoke, individuals who dual use and individuals who vape were particularly keen about access to professional quit support (eg, quit coach). Shared limitations included the presence of too much text and the need to create an account. Individuals who dual use and individuals who vape thought that the content was geared toward older adults and indicated that there was a lack of information about vaping and personalized content. Regarding suggestions for improvement, participants stated that the site needed more interaction, intuitive organization, improved interface esthetics, a complementary smartphone app, forum discussion tags, more information for different tobacco user profiles, and user testimonials. Individuals who vape were particularly interested in website user reviews. In addition, individuals who vape were more interested in an intrinsic approach to quitting (eg, mindfulness) compared with extrinsic approaches (eg, material incentives), the latter of which was endorsed by more individuals who dual use and individuals who smoke. Conclusions: The findings of this study provide directions for enhancing the saliency of web-based cessation programs for a variety of tobacco use behaviors that hallmark current tobacco use. %M 38064266 %R 10.2196/43096 %U https://formative.jmir.org/2023/1/e43096 %U https://doi.org/10.2196/43096 %U http://www.ncbi.nlm.nih.gov/pubmed/38064266 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e39310 %T The Hombres Saludables Physical Activity Web-Based and Mobile Phone Intervention: Pilot Randomized Controlled Trial With Latino Men %A Dulin,Akilah J %A Dunsiger,Shira %A Benitez,Tanya %A Larsen,Britta %A Marcus,Bess H %A Champion,Gregory %A Gans,Kim M %+ Center for Health Promotion and Health Equity, Brown University, Box G-S121-8, Providence, RI, 02912, United States, 1 4018635392, akilah_dulin@brown.edu %K physical activity %K Latino %K Hispanic %K men %K eHealth %K expert system %K internet %K SMS text messaging %K mobile phone %K social media %K mobile health %K mHealth %K mobile phone %D 2023 %7 7.12.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Owing to structural-level, interpersonal-level, and individual-level barriers, Latino men have disproportionately high rates of physical inactivity and experience related chronic diseases. Despite these disparities, few physical activity (PA) interventions are culturally targeted for Latino men. Objective: This study reported the feasibility and acceptability of Hombres Saludables PA intervention for Latino men. We also reported the preliminary efficacy of the intervention on PA change and provided the results of the exploratory moderator and mediator analysis. Methods: We completed a 6-month, single-blind, pilot randomized controlled trial of Hombres Saludables with Latino men aged between 18 and 65 years. Men were randomized to either (1) a theory-driven, individually tailored, internet-based and SMS text message–based, Spanish-language PA intervention arm or (2) a nutrition and wellness attention contact control arm that was also delivered via the web and SMS text message. We assessed the primary study outcomes of feasibility using participant retention and acceptability using postintervention survey and open-ended interview questions. We measured the preliminary efficacy via change in minutes of moderate to vigorous PA per week using ActiGraph wGT3X-BT accelerometry (primary measure) and self-reported minutes per week using 7-day Physical Activity Recall. Participants completed the assessments at study enrollment and after 6 months. Results: The 38 participants were predominantly Dominican (n=8, 21%) or Guatemalan (n=5, 13%), and the mean age was 38.6 (SD 12.43) years. Retention rates were 91% (21/23) for the PA intervention arm and 100% (15/15) for the control arm. Overall, 95% (19/20) of the intervention arm participants reported that the Hombres study was somewhat to very helpful in getting them to be more physically active. Accelerometry results indicated that participants in the intervention group increased their PA from a median of 13 minutes per week at study enrollment to 34 minutes per week at 6 months, whereas the control group participants showed no increases. On the basis of self-reports, the intervention group was more likely to meet the US PA guidelines of 150 minutes per week of moderate to vigorous PA at 6-month follow-up, with 42% (8/19) of the intervention participants meeting the PA guidelines versus 27% (4/15) of the control participants (odds ratio 3.22, 95% CI 0.95-13.69). Exploratory analyses suggested conditional effects on PA outcomes based on baseline stage of motivational readiness, employment, and neighborhood safety. Conclusions: The PA intervention demonstrated feasibility and acceptability. Results of this pilot study indicate that the Hombres Saludables intervention is promising for increasing PA in Latino men and suggest that a fully powered trial is warranted. Our technology-based PA intervention provides a potentially scalable approach that can improve health in a population that is disproportionately affected by low PA and related chronic disease. Trial Registration: ClinicalTrials.gov NCT03196570; https://classic.clinicaltrials.gov/ct2/show/NCT03196570 International Registered Report Identifier (IRRID): RR2-10.2196/23690 %M 38060285 %R 10.2196/39310 %U https://www.jmir.org/2023/1/e39310 %U https://doi.org/10.2196/39310 %U http://www.ncbi.nlm.nih.gov/pubmed/38060285 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46830 %T Repetitive Transcranial Magnetic Stimulation With and Without Text4Support for the Treatment of Resistant Depression: Protocol for a Patient-Centered Multicenter Randomized Controlled Pilot Trial %A Adu,Medard Kofi %A Dias,Raquel da Luz %A Agyapong,Belinda %A Eboreime,Ejemai %A Sapara,Adegboyega O %A Lawal,Mobolaji A %A Chew,Corina %A Diamond Frost,Karen %A Li,Daniel %A Flynn,Michael %A Hassan,Sameh %A Saleh,Ahmed %A Sridharan,Sanjana %A White,Matt %A Agyapong,Vincent IO %+ Department of Psychiatry, Dalhousie University, 5909 Veterans Memorial Lane, 8th Floor, Abbie J. Lane Memorial Building, QEII Health Sciences Centre, Halifax, NS, B3H 2E2, Canada, 1 780 215 7771, vn602367@dal.ca %K repetitive transcranial magnetic stimulation %K treatment-resistant depression %K cognitive behavioral therapy %K Text4Support %K text messaging %K major depressive disorder %D 2023 %7 7.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Treatment-resistant depression (TRD) is the inability of a patient with major depressive disorder (MDD) to accomplish or achieve remission after an adequate trial of antidepressant treatments. Several combinations and augmentation treatment strategies for TRD exist, including the use of repetitive transcranial magnetic stimulation (rTMS), and new therapeutic options are being introduced. Text4Support, a text message–based form of cognitive behavioral therapy that allows patients with MDD to receive daily supportive text messages for correcting or altering negative thought patterns through positive reinforcement, may be a useful augmentation treatment strategy for patients with TRD. It is however currently unknown if adding the Text4Support intervention will enhance the response of patients with TRD to rTMS treatment. Objective: This study aims to assess the initial comparative clinical effectiveness of rTMS with and without the Text4Support program as an innovative patient-centered intervention for the management of patients diagnosed with TRD. Methods: This study is a multicenter, prospective, parallel-design, 2-arm, rater-blinded randomized controlled pilot trial. The recruitment process is scheduled to last 12 months. It will involve active treatment for 6 weeks, observation, and a follow-up period of 6 months for participants in the study arms. In total, 200 participants diagnosed with TRD at rTMS care clinics in Edmonton, Alberta, and rTMS clinics in Halifax, Nova Scotia will be randomized to 1 of 2 treatment arms (rTMS sessions alone or rTMS sessions plus Text4Support intervention). Participants in each group will be made to complete evaluation measures at baseline, and 1, 3, and 6 months. The primary outcome measure will be the mean change in the scores of the Patient Health Questionnaire-9 (PHQ-9). The secondary outcome measures will involve the scores of the 7-item Generalized Anxiety Disorders Scale (GAD-7), Columbia-Suicide Severity Rating Scale (CSSRS), and World Health Organization-Five Well-Being Index (WHO-5). Patient data will be analyzed with descriptive statistics, repeated measures, and correlational analyses. Qualitative data will be analyzed using the thematic analysis framework. Results: The results of the study are expected to be available 18 months from the start of recruitment. We hypothesize that participants enrolled in the rTMS plus Text4Support intervention treatment arm of the study will achieve superior outcomes compared with the outcomes of participants enrolled in the rTMS alone arm. Conclusions: The application of the combination of rTMS and Text4Support has not been investigated previously. Therefore, we hope that this study will provide a concrete base of data to evaluate the practical application and efficacy of using the novel combination of these 2 treatment modalities. International Registered Report Identifier (IRRID): PRR1-10.2196/46830 %M 38060308 %R 10.2196/46830 %U https://www.researchprotocols.org/2023/1/e46830 %U https://doi.org/10.2196/46830 %U http://www.ncbi.nlm.nih.gov/pubmed/38060308 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42497 %T The Effect of Mobile eHealth Education to Improve Knowledge, Skills, Self-Care, and Mobile eHealth Literacies Among Patients With Diabetes: Development and Evaluation Study %A Guo,Sophie Huey-Ming %A Lin,Jiun-Lu %A Hsing,Hung-Chun %A Lee,Chun-Chuan %A Chuang,Shih-Ming %+ Department of Nursing, Mackay Medical College, No.46, Sec. 3, Zhongzheng Rd., Sanzhi Dist., New Taipei, 25245, Taiwan, 886 26360303 ext 1326, sophiecgu@gmail.com %K mobile eHealth technology %K mHealth literacy %K eHealth literacy %K diabetes %K HbA1c %K self-care behavior %D 2023 %7 6.12.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: The promotion of mobile health (mHealth) and eHealth technologies as tools for managing chronic diseases, particularly diabetes mellitus, is on the rise. Nevertheless, individuals with diabetes frequently face a literacy gap that hinders their ability to fully leverage the benefits offered by these resources. Enhancing technology literacy to facilitate the adoption of mobile eHealth services poses a significant challenge in numerous countries. Objective: This study aims to develop an educational mobile eHealth literacy (eHL) program for patients with diabetes and to evaluate its effect on patients’ outcomes. Methods: This study designed a mobile eHL education program comprising 2 modules specifically tailored for individuals with type 2 diabetes (T2D). These modules focused on guiding participants through the process of effectively navigating reliable health websites and utilizing diabetes-related apps. Using a pre- and posttest experimental design, the study featured an intervention group and a control group. Participants were recruited from 3 outpatient departments in hospitals, and assessments were conducted both before and after the intervention, along with a follow-up measure at the 3-month mark. The evaluation encompassed sociodemographic characteristics, computer and internet proficiency, mobile app usage, mobile eHL, and patient outcomes such as self-care behaviors and glycated hemoglobin (HbA1c) levels. Results: The analysis included a total of 132 eligible participants. Significant differences were observed in the mean scores of knowledge (P<.001) and skills (P<.001) related to computers, the web, and mobile devices at the initiation of the study and after the intervention. During the 3-month follow-up, the findings indicated a significant improvement in mobile eHL (t114=3.391, P=.001) and mHealth literacy (mHL, a subconcept of mobile eHL; t114=3.801, P<.001) within the intervention group, whereas no such improvement was observed in the control group. The chi-square values from the McNemar test underscored that individuals with uncontrolled diabetes (HbA1c≥7%) in the intervention group exhibited more improvement compared with the control group. The generalized estimating equations model unveiled a significant difference in the change of general mHL in the intervention group (β=1.91, P=.047) and self-care behavior in the control group from T0 to T2 (β=–8.21, P=.015). Despite being small, the effect sizes for mobile eHL (d=0.49) and HbA1c (d=0.33) in the intervention group were greater than those in the control group (d=0.14 and d=0.16, respectively). Conclusions: The implementation of a mobile eHL education intervention demonstrates a positive influence on the familiarity of patients with T2D regarding health technology, leading to favorable glycemic outcomes. While additional studies are warranted for a more comprehensive understanding, this program emerges as a promising solution for enhancing patients’ uptake of digital health technology. %M 38055321 %R 10.2196/42497 %U https://www.jmir.org/2023/1/e42497 %U https://doi.org/10.2196/42497 %U http://www.ncbi.nlm.nih.gov/pubmed/38055321 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e46558 %T Mobile Technology–Based Interventions for Stroke Self-Management Support: Scoping Review %A Thompson,Alexandra N %A Dawson,Deirdre R %A Legasto-Mulvale,Jean Michelle %A Chandran,Nivetha %A Tanchip,Chelsea %A Niemczyk,Veronika %A Rashkovan,Jillian %A Jeyakumar,Saisa %A Wang,Rosalie H %A Cameron,Jill I %A Nalder,Emily %+ Rehabilitation Sciences Institute, Temerty Faculty of Medicine, University of Toronto, Suite 160, 500 University Avenue, Toronto, ON, M5G 1V7, Canada, 1 416 978 5937, emily.nalder@utoronto.ca %K stroke %K chronic disease %K self-management %K rehabilitation %K mobile health %K mHealth %K eHealth %K telehealth %K telemedicine %K digital health %K mobile phone %D 2023 %7 6.12.2023 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: There is growing interest in enhancing stroke self-management support using mobile health (mHealth) technology (eg, smartphones and apps). Despite this growing interest, “self-management support” is inconsistently defined and applied in the poststroke mHealth intervention literature, which limits efforts to synthesize and compare evidence. To address this gap in conceptual clarity, a scoping review was conducted. Objective: The objectives were to (1) identify and describe the types of poststroke mHealth interventions evaluated using a randomized controlled trial design, (2) determine whether (and how) such interventions align with well-accepted conceptualizations of self-management support (the theory by Lorig and Holman and the Practical Reviews in Self-Management Support [PRISMS] taxonomy by Pearce and colleagues), and (3) identify the mHealth functions that facilitate self-management. Methods: A scoping review was conducted according to the methodology by Arksey and O’Malley and Levac et al. In total, 7 databases were searched. Article screening and data extraction were performed by 2 reviewers. The data were analyzed using descriptive statistics and content analysis. Results: A total of 29 studies (26 interventions) were included. The interventions addressed 7 focal areas (physical exercise, risk factor management, linguistic exercise, activities of daily living training, medication adherence, stroke education, and weight management), 5 types of mobile devices (mobile phones or smartphones, tablets, wearable sensors, wireless monitoring devices, and laptops), and 7 mHealth functions (educating, communicating, goal setting, monitoring, providing feedback, reminding, and motivating). Collectively, the interventions aligned well with the concept of self-management support. However, on an individual basis (per intervention), the alignment was less strong. Conclusions: On the basis of the results, it is recommended that future research on poststroke mHealth interventions be more theoretically driven, more multidisciplinary, and larger in scale. %M 38055318 %R 10.2196/46558 %U https://mhealth.jmir.org/2023/1/e46558 %U https://doi.org/10.2196/46558 %U http://www.ncbi.nlm.nih.gov/pubmed/38055318 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 10 %N %P e47542 %T Identifying the Active Ingredients of a Computerized Speech and Language Therapy Intervention for Poststroke Aphasia: Multiple Methods Investigation Alongside a Randomized Controlled Trial %A Harrison,Madeleine %A Palmer,Rebecca %A Cooper,Cindy %+ Sheffield Centre for Health and Related Research, University of Sheffield, 30 Regent St, Sheffield, S1 4DA, United Kingdom, 44 1142159696, madeleine.harrison@sheffield.ac.uk %K aphasia %K stroke %K computer therapy %K tele-rehabilitation %K speech and language therapy %K word finding %K qualitative %K language %K language therapy %K speech therapy %K aphasia therapy %K speech %K interview %K self managed %K computer aphasia %K persistent aphasia %K rehabilitation %K machines %K technology %K computer %K online %K online health %K ehealth %K digital health %D 2023 %7 5.12.2023 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: Aphasia is a communication disorder affecting more than one-third of stroke survivors. Computerized Speech and Language Therapy (CSLT) is a complex intervention requiring computer software, speech and language therapists, volunteers, or therapy assistants, as well as self-managed practice from the person with aphasia. CSLT was found to improve word finding, a common symptom of aphasia, in a multicenter randomized controlled trial (Clinical and Cost Effectiveness of Computer Treatment for Aphasia Post Stroke [Big CACTUS]). Objective: This study provides a detailed description of the CSLT intervention delivered in the Big CACTUS trial and identified the active ingredients of the intervention directly associated with improved word finding for people with aphasia. Methods: We conducted a multiple methods study within the context of a randomized controlled trial. In study 1, qualitative interviews explored key informants’ understanding of the CSLT intervention, how the components interacted, and how they could be measured. Qualitative data were transcribed verbatim and analyzed thematically. Qualitative findings informed the process measures collected as part of a process evaluation of the CSLT intervention delivered in the Big CACTUS trial. In study 2, quantitative analyses explored the relationship between intervention process measures (length of computer therapy access; therapists’ knowledge of CSLT; degree of rationale for CSLT tailoring; and time spent using the software to practice cued confrontation naming, noncued naming, and using words in functional sentences) and change in word-finding ability over a 6-month intervention period. Results: Qualitative interviews were conducted with 7 CSLT approach experts. Thematic analysis identified four overarching components of the CSLT approach: (1) the StepByStep software (version 5; Steps Consulting Ltd), (2) therapy setup: tailoring and personalizing, (3) regular independent practice, and (4) support and monitoring. Quantitative analyses included process and outcome data from 83 participants randomized to the intervention arm of the Big CACTUS trial. The process measures found to be directly associated with improved word-finding ability were therapists providing a thorough rationale for tailoring the computerized therapy exercises and the amount of time the person with aphasia spent using the computer software to practice using words in functional sentences. Conclusions: The qualitative exploration of the CSLT approach provided a detailed description of the components, theories, and mechanisms underpinning the intervention and facilitated the identification of process measures to be collected in the Big CACTUS trial. Quantitative analysis furthered our understanding of which components of the intervention are associated with clinical improvement. To optimize the benefits of using the CSLT approach for word finding, therapists are advised to pay particular attention to the active ingredients of the intervention: tailoring the therapy exercises based on the individual’s specific language difficulties and encouraging people with aphasia to practice the exercises focused on saying words in functional sentences. Trial Registration: ISRCTN Registry ISRCTN68798818; https://www.isrctn.com/ISRCTN68798818 %M 38051577 %R 10.2196/47542 %U https://rehab.jmir.org/2023/1/e47542 %U https://doi.org/10.2196/47542 %U http://www.ncbi.nlm.nih.gov/pubmed/38051577 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e48461 %T Guide Development for eHealth Interventions Targeting People With a Low Socioeconomic Position: Participatory Design Approach %A Faber,Jasper S %A Al-Dhahir,Isra %A Kraal,Jos J %A Breeman,Linda D %A van den Berg-Emons,Rita J G %A Reijnders,Thomas %A van Dijk,Sandra %A Janssen,Veronica R %A Kraaijenhagen,Roderik A %A Visch,Valentijn T %A Chavannes,Niels H %A Evers,Andrea W M %+ Department of Human-Centered Design, Delft University of Technology, Landbergstraat 15, Delft, 2628 CE, Netherlands, 31 0640850881, j.s.faber@tudelft.nl %K eHealth %K guide %K guidelines professionals %K intervention development %K intervention evaluation %K low socioeconomic position %K low socioeconomic status %K risk groups %K tailored care %D 2023 %7 4.12.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: People with a low socioeconomic position (SEP) are less likely to benefit from eHealth interventions, exacerbating social health inequalities. Professionals developing eHealth interventions for this group face numerous challenges. A comprehensive guide to support these professionals in their work could mitigate these inequalities. Objective: We aimed to develop a web-based guide to support professionals in the development, adaptation, evaluation, and implementation of eHealth interventions for people with a low SEP. Methods: This study consisted of 2 phases. The first phase involved a secondary analysis of 2 previous qualitative and quantitative studies. In this phase, we synthesized insights from the previous studies to develop the guide’s content and information structure. In the second phase, we used a participatory design process. This process included iterative development and evaluation of the guide’s design with 11 professionals who had experience with both eHealth and the target group. We used test versions (prototypes) and think-aloud testing combined with semistructured interviews and a questionnaire to identify design requirements and develop and adapt the guide accordingly. Results: The secondary analysis resulted in a framework of recommendations for developing the guide, which was categorized under 5 themes: development, reach, adherence, evaluation, and implementation. The participatory design process resulted in 16 requirements on system, content, and service aspects for the design of the guide. For the system category, the guide was required to have an open navigation strategy leading to more specific information and short pages with visual elements. Content requirements included providing comprehensible information, scientific evidence, a user perspective, information on practical applications, and a personal and informal tone of voice. Service requirements involved improving suitability for different professionals, ensuring long-term viability, and a focus on implementation. Based on these requirements, we developed the final version of “the inclusive eHealth guide.” Conclusions: The inclusive eHealth guide provides a practical, user-centric tool for professionals aiming to develop, adapt, evaluate, and implement eHealth interventions for people with a low SEP, with the aim of reducing health disparities in this population. Future research should investigate its suitability for different end-user goals, its external validity, its applicability in specific contexts, and its real-world impact on social health inequality. %M 38048148 %R 10.2196/48461 %U https://www.jmir.org/2023/1/e48461 %U https://doi.org/10.2196/48461 %U http://www.ncbi.nlm.nih.gov/pubmed/38048148 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e52464 %T Efficacy of a WeChat-Based Multimodal Digital Transformation Management Model in New-Onset Mild to Moderate Hypertension: Randomized Clinical Trial %A Wang,Yijun %A Guo,Fuding %A Wang,Jun %A Li,Zeyan %A Tan,Wuping %A Xie,Mengjie %A Yang,Xiaomeng %A Duan,Shoupeng %A Song,Lingpeng %A Cheng,Siyi %A Liu,Zhihao %A Liu,Hengyang %A Qiao,Jiaming %A Wang,Yueyi %A Zhou,Liping %A Zhou,Xiaoya %A Jiang,Hong %A Yu,Lilei %+ Department of Cardiology, Renmin Hospital of Wuhan University, 238 Jiefang Road, Wuhan, 430060, China, 86 2788041911, lileiyu@whu.edu.cn %K digital health care %K mHealth %K mobile health %K apps %K applications %K controlled trials %K digital transformation %K precision %K multimodal %K precision medicine %K hypertension %K blood pressure %K WeChat %K social media %K self-management %K mobile phone %D 2023 %7 4.12.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: The advantages of multimodal digitally transformed mobile health management for patients diagnosed with mild to moderate hypertension are not yet established. Objective: We aim to evaluate the therapeutic benefits of a novel WeChat-based multimodal digital transforming management model in mobile health blood pressure (BP) management. Methods: This randomized controlled clinical trial included 175 individuals with new-onset mild to moderate hypertension who were admitted to our center between September and October 2022. The patients were randomly assigned to either the multimodal intervention group (n=88) or the usual care group (n=87). The primary composite outcome was home and office BP differences after 6 months. The major secondary outcomes were 6-month quality-of-life scores, including the self-rating anxiety scale, self-rating depression scale, and Pittsburgh Sleep Quality Index. Results: The mean home BP decreased from 151.74 (SD 8.02)/94.22 (SD 9.32) to 126.19 (SD 8.45)/82.28 (SD 9.26) mm Hg in the multimodal intervention group and from 150.78 (SD 7.87)/91.53 (SD 9.78) to 133.48 (SD 10.86)/84.45 (SD 9.19) mm Hg in the usual care group, with a mean difference in systolic blood pressure and diastolic blood pressure of –8.25 mm Hg (95% CI –11.71 to –4.78 mm Hg; P<.001) and –4.85 mm Hg (95% CI –8.41 to –1.30 mm Hg; P=.008), respectively. The mean office BP decreased from 153.64 (SD 8.39)/93.56 (SD 8.45) to 127.81 (SD 8.04)/ 82.16 (SD 8.06) mm Hg in the multimodal intervention group and from 151.48 (SD 7.14)/(91.31 (SD 9.61) to 134.92 (SD 10.11)/85.09 (SD 8.26) mm Hg in the usual care group, with a mean difference in systolic blood pressure and diastolic blood pressure of –9.27 mm Hg (95% CI –12.62 to –5.91 mm Hg; P<.001) and –5.18 mm Hg (95% CI –8.47 to –1.89 mm Hg; P=.002), respectively. From baseline to 6 months, home BP control <140/90 mm Hg was achieved in 64 (72.7%) patients in the multimodal intervention group and 46 (52.9%) patients in the usual care group (P=.007). Meanwhile, home BP control <130/80 mm Hg was achieved in 32 (36.4%) patients in the multimodal intervention group and 16 (18.4%) patients in the usual care group (P=.008). After 6 months, there were significant differences in the quality-of-life total and graded scores, including self-rating anxiety scale scores (P=.04), self-rating depression scale scores (P=.03), and Pittsburgh Sleep Quality Index scores (P<.001), in the multimodal intervention group compared with the usual care group. Conclusions: The WeChat-based multimodal intervention model improved the BP control rates and lowered the BP levels more than the usual care approach. The multimodal digital transforming management model for hypertension represents an emerging medical practice that utilizes the individual’s various risk factor profiles for primary care and personalized therapy decision-making in patients with hypertension. Trial Registration: Chinese Clinical Trial Registry ChiCTR2200063550; https://www.chictr.org.cn/showproj.html?proj=175816 %M 38048156 %R 10.2196/52464 %U https://www.jmir.org/2023/1/e52464 %U https://doi.org/10.2196/52464 %U http://www.ncbi.nlm.nih.gov/pubmed/38048156 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46336 %T The Effectiveness of Publicly Available Web-Based Interventions in Promoting Health App Use, Digital Health Literacy, and Media Literacy: Pre-Post Evaluation Study %A König,Lars %A Suhr,Ralf %+ Institut für Medizinische Soziologie und Rehabilitationswissenschaft, Charité – Universitätsmedizin Berlin, Charitéplatz 1, Berlin, 10117, Germany, 49 30419549262, lars.koenig@charite.de %K digital health literacy %K e-learning %K health apps %K health education %K health literacy %K media literacy %K mHealth %K mobile health %K serious games %K user experience %K web-based intervention %D 2023 %7 4.12.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: According to the World Health Organization, implementing mobile health (mHealth) technologies can increase access to quality health services worldwide. mHealth apps for smartphones, also known as health apps, are a central component of mHealth, and they are already used in diverse medical contexts. To benefit from health apps, potential users need specific skills that enable them to use such apps in a responsible and constructive manner. Objective: This study aimed to evaluate the effectiveness of the free and widely used web-based intervention, The APPocalypse?. Besides providing knowledge about health apps, the web-based intervention was designed to promote digital health and media literacy by teaching skills that enable users to distinguish between trustworthy and less trustworthy health apps. It was hypothesized that after completing the web-based intervention, participants’ knowledge in the domain of health apps, their digital health literacy, and their media literacy would be higher than it was before completing the web-based intervention. Methods: The study was divided into 3 parts. During part 1, participants (n=365; 181 female, 181 male, and 3 diverse; mean age 17.74, SD 1.391 years) provided demographic information and answered the pre- and postmeasurements. The measurements included questionnaires about participants’ knowledge in the domain of health apps, digital health literacy, and media literacy. During part 2, participants had 1 week to complete the web-based intervention. During part 3, participants answered the pre- and postmeasurements again. Furthermore, they answered educational quality and user experience questionnaires. Bayesian paired samples 2-tailed t tests were conducted to test the hypotheses. Results: Overall, the results support the hypotheses. After completing the web-based intervention, participants demonstrated more elaborate knowledge in the domain of health apps. Specifically, they displayed higher competencies in the domains of subjective (Bayes factor10 [BF10]=1.475×1079; effect size δ=–1.327) and objective health app knowledge (BF10=8.162×1080; effect size δ=–1.350). Furthermore, participants demonstrated higher digital health literacy. Specifically, they displayed higher competencies in the domains of information appraisal (BF10=3.413×1043; effect size δ=–0.870), information searching (BF10=3.324×1023; effect size δ=–0.604), evaluating reliability (BF10=3.081×1035; effect size δ=–0.766), and determining relevance (BF10=3.451×1024; effect size δ=–0.618). Regarding media literacy, the results were mixed. Participants displayed higher competencies in the domain of technology literacy beliefs (BF10=1.533×1021; effect size δ=–0.570). In the domain of technology control beliefs, their competencies did not seem to improve (BF10=0.109; effect size δ=–0.058). In comparison to relevant benchmarks, the web-based intervention offers exceptional educational quality and a superior user experience. Conclusions: The free web-based intervention The APPocalypse? might promote the constructive use of health apps, digital health literacy, and media literacy. Therefore, it may contribute to achieving the health-related United Nations Sustainable Development Goals. %M 38048146 %R 10.2196/46336 %U https://www.jmir.org/2023/1/e46336 %U https://doi.org/10.2196/46336 %U http://www.ncbi.nlm.nih.gov/pubmed/38048146 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e40735 %T Effectiveness of Different Telerehabilitation Strategies on Pain and Physical Function in Patients With Knee Osteoarthritis: Systematic Review and Meta-Analysis %A Xiang,Wu %A Wang,Jun-Yu %A Ji,Bing-jin %A Li,Li-Jun %A Xiang,Han %+ Department of Radiology, Daping Hospital, Army Medical University, Yuzhong District, No. 10 Changjiang Branch Road, Chongqing, 400042, China, 86 23 6874 6920, 903274184@qq.com %K telerehabilitation %K telemedicine %K knee osteoarthritis %K pain %K physical function %K systematic review %K meta-analysis %D 2023 %7 4.12.2023 %9 Review %J J Med Internet Res %G English %X Background: Knee osteoarthritis (OA) is a chronic, degenerative bone and joint disease. It can lead to major pressure to the quality of life and mental health of patients, and also brings a serious economic burden to society. However, it is difficult for patients with knee OA to access rehabilitation when discharging from the hospital. Internet-based rehabilitation is one of the promising telemedicine strategies for the improvement of knee OA, but the effect of different telerehabilitation strategies on knee OA is not clear. Objective: The aim of this systematic review and meta-analysis was to identify telerehabilitation strategies attributing to the improvement of pain and physical function outcomes in patients with knee OA. Methods: We reviewed and analyzed telerehabilitation strategies from randomized controlled trials (RCTs) comparing telerehabilitation with conventional treatment or usual care. For each strategy, we examined whether RCTs that applied the telerehabilitation strategy resulted in a significant improvement in pain or physical function compared with conventional treatment or usual care. Results: We included 6 RCTs (n=734) incorporating 8 different telerehabilitation strategies. The duration of the interventions ranged from 1 to 48 weeks, and sample sizes ranged from 20 to 350 patients. The results showed that RCTs that provided telerehabilitation were found to be more effective than conventional treatments for improving pain (P=.003; standardized mean difference [SMD] –0.21, 95% CI –0.35 to –0.07), but not physical function (P=.24; SMD –0.09, 95% CI –0.25 to 0.06). Furthermore, this systematic review and meta-analysis indicated that there is no significant correlation between different telerehabilitation strategies and the pain and physical function of patients with knee OA. Conclusions: This systematic review and meta-analysis showed that telerehabilitation programs could relieve pain but not improve physical function for patients with knee OA. These results indicated that telerehabilitation is beneficial for the implementation of home rehabilitation exercises for patients with knee OA, thereby reducing the economic burden of health. However, there were limitations in terms of the number of search results and the number of studies that were eligible for this review and meta-analysis. Therefore, the results need to be interpreted with caution, and more high-quality studies with large samples are needed to focus on the long-term outcomes of telerehabilitation for patients with knee OA to address this limitation. %M 37982411 %R 10.2196/40735 %U https://www.jmir.org/2023/1/e40735 %U https://doi.org/10.2196/40735 %U http://www.ncbi.nlm.nih.gov/pubmed/37982411 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 9 %N %P e49735 %T Development of Quality of Life in Adolescents and Young Adults With Cancer Using a Patient Support Smartphone App: Prepost Interventional Study %A Bentsen,Line %A Hanghøj,Signe %A Hjerming,Maiken %A Bergmann,Mette Buur %A Thycosen,Marianne %A Borup,Anette %A Larsen,Camilla %A Pappot,Helle %+ Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, Copenhagen, 2100, Denmark, 45 30113524, line.bentsen.01@regionh.dk %K adolescent %K young adult %K cancer %K quality of life %K eHealth %K smartphone application %K application %K development %K interventional study %K youth %K grief %K symptom tracker %K social community %K Denmark %K physical functioning %K treatment %K mobile phone %D 2023 %7 4.12.2023 %9 Original Paper %J JMIR Cancer %G English %X Background: Adolescents and young adults often experience existential concerns in addition to side effects during a cancer trajectory, which they often carry alone. Thus, cohesion with other adolescents and young adults with cancer is essential but difficult due to the relatively small, widely dispersed nationwide population. In cocreation, a smartphone app has been developed and includes an information bank, a symptom tracker, and a social community platform, aiming to improve the quality of life (QoL) in this patient group. Objective: This nationwide, multicenter study aimed to investigate the QoL in adolescents and young adults undergoing a cancer trajectory as they used the app for 6 weeks. Methods: Via youth support initiatives, participants were recruited from hospitals in all regions of Denmark. Inclusion criteria were patients with cancer aged 15-29 years who either initiated any cancer treatment or started follow-up after cancer treatment within 30 days. Participants used the adolescents and young adults cancer app for 6 weeks. Before and after the 6 weeks of app use, they completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The participants were divided into a treatment and a follow-up group for analysis. A high score for a functional scale or the global health or overall QoL represents a high or healthy level of functioning or high QoL, respectively; however, a high score for a symptom scale or item represents a high level of symptomatology. Results: Overall, 81 participants were recruited. However, 4 participants did not answer the questionnaire and 6 participants did not use the app. In the treatment group (n=36), significant improvement was found in 2 domains: “Role functioning” (baseline median 33.33, IQR 16.67-83.33 vs 6 weeks median 66.67, IQR 33.33-83.33; P=.04) and “Pain” (baseline median 33.33, IQR 16.67-50.00 vs 6 weeks median 16.67, IQR 0.00-33.33; P=.04). The “Global health/Overall QoL” scale remained stable (baseline median 58.33, IQR 45.83-77.08 vs 6 weeks median 62.50, IQR 41.67-75.00; P=.25). In the follow-up group (n=35), significant improvement was found in 3 domains: “Physical functioning” (baseline median 79.23, IQR 73.33-93.33 vs 6 weeks median 82.86, IQR 73.33-100.00; P=.03), “Cognitive functioning” (baseline median 62.38, IQR 50.00-83.33 vs 6 weeks median 69.52, IQR 50.00-100.00; P=.02), and “Social functioning” (baseline median 76.19, IQR 50.00-100.00 vs 6 weeks median 85.71, IQR 83.33-100.00; P=.05), as well as in the “Global health/Overall QoL” scale (baseline median 57.14, IQR 83.33-100.00 vs 6 weeks median 75.0, IQR 62.91-85.73; P<.001). Conclusions: In this study, we found an improvement in specific QoL scales for both participants in treatment and follow-up when using the app for 6 weeks. The global health or overall QoL score improved significantly in the follow-up group. In the treatment group, it remained stable. International Registered Report Identifier (IRRID): RR2-10.2196/10098 %M 38048144 %R 10.2196/49735 %U https://cancer.jmir.org/2023/1/e49735 %U https://doi.org/10.2196/49735 %U http://www.ncbi.nlm.nih.gov/pubmed/38048144 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48271 %T Designing Mobile Phone Text Messages Using the Behavior Change Wheel Framework to Influence Food Literacy in Adults With Type 2 Diabetes in Kenya: Protocol for a Systematic Development Study %A Mokaya,Moses %A Kyallo,Florence %A Yiga,Peter %A Koole,Janna Lena %A Boedt,Tessy %A Vangoitsenhoven,Roman %A Matthys,Christophe %+ Experimental and Clinical Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Herestraat 49, Leuven, 3000, Belgium, 32 16 347000, christophe.matthys@uzleuven.be %K behavior change techniques %K Behavior Change Wheel %K type 2 diabetes %K low-income populations %K mHealth %K mobile health %K glycemic control %K adults %K diabetes %K Africa %K mobile phone %K support care %K care %K support %K behavior %K diabetes %D 2023 %7 4.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: The worldwide prevalence of type 2 diabetes (T2D) has increased in the past decade, and it is projected to increase by 126% by 2045 in Africa. At the same time, mobile phone use has increased in Africa, providing a potential for innovative mobile health interventions to support diabetes care. Objective: This study aimed to apply the Behavior Change Wheel (BCW) framework to develop text messages to influence food literacy in adults with T2D in urban Kenya. Methods: The 8 steps of the BCW framework guided the development of text messages: (1) Define the problem in behavioral terms; (2) select target behaviors; (3) specify the target behaviors based on who needs to perform the behaviors, what needs to change, and when, where, how often, and with whom; (4) identify what needs to change; (5) identify intervention functions; (6) select policy categories; (7) select behavior change techniques (BCTs); and (8) select the mode of delivery. Recent exploratory studies in Kenya and other low- and middle-income countries provided information that was used to contextualize the intervention. Results: In step 1, the behavioral problem was defined as unhealthy dietary patterns among adults with T2D. In step 2, based on a qualitative study in the target population, the target behavior was selected to be evaluation of reliable sources of information, and selection and preparation of healthy food. In step 3, unhealthy dietary patterns were selected. In step 4, 10 domains of the Theoretical Domains Framework were identified, and in step 5, 5 intervention functions were linked to the domains and unhealthy dietary patterns were specified. In step 6, communication and regulations were identified as policy categories, while in step 7, 9 BCTs were selected from the Behavior Change Technique Taxonomy version 1. In step 8, the most suitable mode of delivery was determined to be mobile text messages. A total of 36 mobile text messages were developed based on the 9 BCTs. Conclusions: This study shows the step-by-step application of the BCW framework to develop mobile text messages to influence food literacy in adults with T2D. International Registered Report Identifier (IRRID): RR1-10.2196/48271 %M 38048150 %R 10.2196/48271 %U https://www.researchprotocols.org/2023/1/e48271 %U https://doi.org/10.2196/48271 %U http://www.ncbi.nlm.nih.gov/pubmed/38048150 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e49718 %T Web-Based Delivery of a Family-Based Dating Abuse Prevention Program for Adolescents Exposed to Interparental Violence: Feasibility and Acceptability Study %A McNaughton Reyes,H Luz %A Armora Langoni,Eliana G %A Sharpless,Laurel %A Moracco,Kathryn E %A Benavides,Quetzabel %A Foshee,Vangie A %+ Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 135 Dauer Dr, Chapel Hill, NC, 27599, United States, 1 9199663215, mcnaught@email.unc.edu %K dating violence %K adolescents %K family-based prevention %K web-based delivery %K feasibility and acceptability %K mobile phone %D 2023 %7 1.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Numerous studies have demonstrated that exposure to caregiver intimate partner violence (IPV) can have cascading negative impacts on children that elevate the risk of involvement in dating abuse. This cascade may be prevented by programs that support the development of healthy relationships in children exposed to IPV. This paper describes the results of a study of the web-based adaptation of an evidence-based dating abuse prevention program for IPV-exposed youth and their maternal caregivers. Core information and activities from an evidence-based program, Moms and Teens for Safe Dates, were adapted to create the web-based program (e-MTSD), which comprises 1 module for mothers only and 5 modules for mother-adolescent dyads to complete together. Objective: The primary objective of this study was to evaluate the feasibility and acceptability of the e-MTSD program and the associated research processes. We also examined the practicability of randomizing mothers to receive SMS text message reminders and an action planning worksheet, which were intended to support engagement in the program. Methods: Mothers were recruited through community organizations and social media advertising and were eligible to participate if they had at least one adolescent aged 12 to 16 years of any gender identity who was willing to participate in the program with them, had experienced IPV after their adolescent was born, and were not currently living with an abusive partner. All mothers were asked to complete the program with their adolescent over a 6- to 8-week period. Participants were randomized to receive SMS text message reminders, action planning, or both using a 2×2 factorial design. Research feasibility was assessed by tracking recruitment, randomization, enrollment, and attrition rates. Program feasibility was assessed by tracking program uptake, completion, duration, and technical problems, and acceptability was assessed using web-based surveys. Results: Over a 6-month recruitment period, 101 eligible mother-adolescent dyads were enrolled in the study and were eligible for follow-up. The median age of the adolescent participants was 14 years; 57.4% (58/101) identified as female, 32.7% (33/101) identified as male, and 9.9% (10/101) identified as gender diverse. All but one mother accessed the program website at least once; 87.1% (88/101) completed at least one mother-adolescent program module, and 74.3% (75/101) completed all 6 program modules. Both mothers and adolescents found the program to be highly acceptable; across all program modules, over 90% of mothers and over 80% of adolescents reported that the modules kept their attention, were enjoyable, were easy to do, and provided useful information. Conclusions: Findings suggest the feasibility of web-based delivery and evaluation of the e-MTSD program. Furthermore, average ratings of program acceptability were high. Future research is needed to assess program efficacy and identify the predictors and outcomes of program engagement. %M 38039070 %R 10.2196/49718 %U https://formative.jmir.org/2023/1/e49718 %U https://doi.org/10.2196/49718 %U http://www.ncbi.nlm.nih.gov/pubmed/38039070 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e50522 %T User-Centered Development of Bolster, an mHealth Intervention for Early Psychosis Caregivers: Needs Assessment, Prototyping, and Field Trial %A Buck,Benjamin %A Wingerson,Mary %A Whiting,Erica %A Snyder,Jaime %A Monroe-DeVita,Maria %A Ben-Zeev,Dror %+ Behavioral Research in Technology and Engineering (BRiTE) Center, Department of Psychiatry and Behavioral Sciences, University of Washington, Box 356560, 1959 NE Pacific Street, Seattle, WA, 98105, United States, 1 206 221 8518, buckbe@uw.edu %K caregiving %K psychosis %K mobile health %K mHealth %K user-centered design %K mobile phone %K artificial intelligence %K AI %D 2023 %7 30.11.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Caregivers play a critical role in the treatment and recovery of youth and young adults at risk for psychosis. Caregivers often report feeling isolated, overwhelmed, and lacking in resources. Mobile health (mHealth) has the potential to provide scalable, accessible, and in-the-moment support to caregivers. To date, few if any mHealth resources have been developed specifically for this population. Objective: The aim of this study was to conduct user-centered design and testing of an mHealth intervention to support early psychosis caregivers. Methods: We conducted a multiphase user-centered development process to develop the Bolster mobile app. In phase 1, a total of 21 caregivers were recruited to participate in a qualitative needs assessment and respond to an initial prototype of the Bolster platform. Content analysis was used to identify key needs and design objectives, which guided the development of the Bolster mobile app. In phase 2, a total of 11 caregivers were recruited to participate in a 1-week field trial wherein they provided qualitative and quantitative feedback regarding the usability and acceptability of Bolster; in addition, they provided baseline and posttest assessments of the measures of distress, illness appraisals, and family communication. Results: In phase 1, participants identified psychoeducation, communication coaching, a guide to seeking services, and support for coping as areas to address. Live prototype interaction sessions led to multiple design objectives, including ensuring that messages from the platform were actionable and tailored to the caregiver experience, delivering messages in multiple modalities (eg, video and text), and eliminating a messaging-style interface. These conclusions were used to develop the final version of Bolster tested in the field trial. In phase 2, of the 11 caregivers, 10 (91%) reported that they would use Bolster if they had access to it and would recommend it to another caregiver. They also reported marked changes in their appraisals of illness (Cohen d=0.55-0.68), distress (Cohen d=1.77), and expressed emotion (Cohen d=0.52). Conclusions: To our knowledge, this study is the first to design an mHealth intervention specifically for early psychosis caregivers. Preliminary data suggest that Bolster is usable, acceptable, and promising to improve key targets and outcomes. A future fully powered clinical trial will help determine whether mHealth can reduce caregiver burdens and increase engagement in services among individuals affected by psychosis. %M 38032692 %R 10.2196/50522 %U https://mental.jmir.org/2023/1/e50522 %U https://doi.org/10.2196/50522 %U http://www.ncbi.nlm.nih.gov/pubmed/38032692 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e45947 %T Exploring Adherence to Pelvic Floor Muscle Training in Women Using Mobile Apps: Scoping Review %A Harper,Rosie C %A Sheppard,Sally %A Stewart,Carly %A Clark,Carol J %+ Faculty of Health and Social Sciences, Bournemouth University, Bournemouth Gateway Building, 12 St Paul’s Lane, Bournemouth, BH8 8GP, United Kingdom, 44 01202 524111, rharper1@bournemouth.ac.uk %K adherence %K behavior change %K mHealth %K mobile apps %K pelvic floor muscle training %K women %D 2023 %7 30.11.2023 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Pelvic floor dysfunction is a public health issue, with 1 in 3 women experiencing symptoms at some point in their lifetime. The gold standard of treatment for pelvic floor dysfunction is supervised pelvic floor muscle training (PFMT); however, adherence to PFMT in women is poor. Mobile apps are increasingly being used in the National Health Service to enable equity in the distribution of health care and increase accessibility to services. However, it is unclear how PFMT mobile apps influence PFMT adherence in women. Objective: We aimed to identify which behavior change techniques (BCTs) have been used in PFMT mobile apps, to distinguish the core “capability, opportunity, and motivation” (COM) behaviors targeted by the BCTs used in PFMT mobile apps, and to compare the levels of PFMT adherence in women between those using PFMT mobile apps and those receiving usual care. Methods: We conducted a scoping review of the literature. Published quantitative literature that compared the use of a PFMT mobile app to a control group was included to address the objectives of the study. The electronic bibliographic databases searched included MEDLINE, CINAHL, Scopus, Web of Science, and PEDro, along with CENTRAL. Studies were also identified from reference searching of systematic reviews. Original articles written in English from 2006 onward were included. Nonexperimental quantitative studies, qualitative studies, studies that use male participants, case studies, web-based interventions, and interventions that use vaginal probes were excluded. Narrative synthesis was conducted on eligible articles based on the aims of the study. Results: Of the 114 records retrieved from the search, a total of 6 articles met the eligibility and inclusion criteria. The total number of participants in the studies was 471. All PFMT mobile apps used the BCT “prompts and cues.” Opportunity was the core COM behavior targeted by the PFMT mobile apps. Higher levels of adherence to PFMT were observed among women using PFMT mobile apps. Conclusions: Digital “prompts and cues” are a BCT commonly used in PFMT mobile apps, and further research is required to practically assess whether a future randomized controlled trial that investigates the effectiveness of digital “prompts and cues” on PFMT adherence in women can be conducted. %M 38032694 %R 10.2196/45947 %U https://mhealth.jmir.org/2023/1/e45947 %U https://doi.org/10.2196/45947 %U http://www.ncbi.nlm.nih.gov/pubmed/38032694 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e51423 %T User-Centered Design of a Gamified Mental Health App for Adolescents in Sub-Saharan Africa: Multicycle Usability Testing Study %A Pozuelo,Julia R %A Moffett,Bianca D %A Davis,Meghan %A Stein,Alan %A Cohen,Halley %A Craske,Michelle G %A Maritze,Meriam %A Makhubela,Princess %A Nabulumba,Christine %A Sikoti,Doreen %A Kahn,Kathleen %A Sodi,Tholene %A , %A van Heerden,Alastair %A O’Mahen,Heather A %+ Department of Global Health and Social Medicine, Harvard Medical School, Harvard University, 641 Huntington Avenue, Boston, MA, 02115, United States, 1 617 432 1707, julia_ruizpozuelo@hms.harvard.edu %K depression %K adolescents %K mental health app %K behavioral activation %K user-centered design %K low- and middle-income countries %K mobile phone %D 2023 %7 30.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: There is an urgent need for scalable psychological treatments to address adolescent depression in low-resource settings. Digital mental health interventions have many potential advantages, but few have been specifically designed for or rigorously evaluated with adolescents in sub-Saharan Africa. Objective: This study had 2 main objectives. The first was to describe the user-centered development of a smartphone app that delivers behavioral activation (BA) to treat depression among adolescents in rural South Africa and Uganda. The second was to summarize the findings from multicycle usability testing. Methods: An iterative user-centered agile design approach was used to co-design the app to ensure that it was engaging, culturally relevant, and usable for the target populations. An array of qualitative methods, including focus group discussions, in-depth individual interviews, participatory workshops, usability testing, and extensive expert consultation, was used to iteratively refine the app throughout each phase of development. Results: A total of 160 adolescents from rural South Africa and Uganda were involved in the development process. The app was built to be consistent with the principles of BA and supported by brief weekly phone calls from peer mentors who would help users overcome barriers to engagement. Drawing on the findings of the formative work, we applied a narrative game format to develop the Kuamsha app. This approach taught the principles of BA using storytelling techniques and game design elements. The stories were developed collaboratively with adolescents from the study sites and included decision points that allowed users to shape the narrative, character personalization, in-app points, and notifications. Each story consists of 6 modules (“episodes”) played in sequential order, and each covers different BA skills. Between modules, users were encouraged to work on weekly activities and report on their progress and mood as they completed these activities. The results of the multicycle usability testing showed that the Kuamsha app was acceptable in terms of usability and engagement. Conclusions: The Kuamsha app uniquely delivered BA for adolescent depression via an interactive narrative game format tailored to the South African and Ugandan contexts. Further studies are currently underway to examine the intervention’s feasibility, acceptability, and efficacy in reducing depressive symptoms. %M 38032691 %R 10.2196/51423 %U https://formative.jmir.org/2023/1/e51423 %U https://doi.org/10.2196/51423 %U http://www.ncbi.nlm.nih.gov/pubmed/38032691 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e50324 %T Sadness-Based Approach-Avoidance Modification Training for Subjective Stress in Adults: Pilot Randomized Controlled Trial %A Rupp,Lydia Helene %A Keinert,Marie %A Böhme,Stephanie %A Schindler-Gmelch,Lena %A Eskofier,Bjoern %A Schuller,Björn %A Berking,Matthias %+ Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Nägelsbachstr. 25a, Erlangen, 91052, Germany, 49 91318567560, lydia.rupp@fau.de %K stress %K emotion %K eHealth %K approach-avoidance %K mental health %K somatic health %K chronic stress %K intervention %K stress-related illness %K app-based %K stress management %K belief %K training %K mobile phone %D 2023 %7 30.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: A key vulnerability factor in mental health problems is chronic stress. There is a need for easy-to-disseminate and effective interventions to advance the prevention of stress-related illnesses. App-based stress management trainings can fulfill this need. As subjectively experienced stress may be influenced by dysfunctional beliefs, modifying their evaluations might reduce subjective stress. Approach-avoidance modification trainings (AAMT) can be used to modify stimulus evaluations and are promising candidates for a mobile stress intervention. As the standard training reactions of the AAMT (swiping and joystick motion) have little valence, emotions could be incorporated as approach and avoidance reactions to enhance the effectiveness of AAMTs. Objective: We aimed to evaluate the feasibility of a mobile emotion-enhanced AAMT that engages users to display sadness to move stress-enhancing beliefs away and display positive emotions to move stress-reducing beliefs toward themselves (emotion-based AAMT using sadness and positive emotions [eAAMT-SP]). We explored the clinical efficacy of this novel intervention. Methods: We allocated 30 adult individuals with elevated stress randomly to 1 of 3 conditions (eAAMT-SP, a swipe control condition, and an inactive control condition). We evaluated the feasibility of the intervention (technical problems, adherence, usability, and acceptability). To explore the clinical efficacy of the intervention, we compared pretest-posttest differences in perceived stress (primary clinical outcome) and 3 secondary clinical outcomes (agreement with and perceived helpfulness of dysfunctional beliefs, emotion regulation, and depressive symptoms) among the conditions. Results: The predetermined benchmarks of 50% for intervention completion and 75% for feasibility of the study design (completion of the study design) were met, whereas the cutoff for technical feasibility of the study design (95% of trials without technical errors) was not met. Effect sizes for usability and acceptability were in favor of the eAAMT-SP condition (compared with the swipe control condition; intelligibility of the instructions: g=−0.86, distancing from dysfunctional beliefs: g=0.22, and approaching functional beliefs: g=0.55). Regarding clinical efficacy, the pretest-posttest effect sizes for changes in perceived stress were g=0.80 for the comparison between the eAAMT-SP and inactive control conditions and g=0.76 for the comparison between the eAAMT-SP and swipe control conditions. Effect sizes for the secondary clinical outcomes indicated greater pretest-posttest changes in the eAAMT-SP condition than in the inactive control condition and comparable changes in the swipe control condition. Conclusions: The findings regarding the feasibility of the intervention were satisfactory except for the technical feasibility of the intervention, which should be improved. The effect sizes for the clinical outcomes provide preliminary evidence for the therapeutic potential of the intervention. The findings suggest that extending the AAMT paradigm through the use of emotions may increase its efficacy. Future research should evaluate the eAAMT-SP in sufficiently powered randomized controlled trials. Trial Registration: German Clinical Trials Registry DRKS00023007; https://drks.de/search/en/trial/DRKS00023007 %M 38032725 %R 10.2196/50324 %U https://formative.jmir.org/2023/1/e50324 %U https://doi.org/10.2196/50324 %U http://www.ncbi.nlm.nih.gov/pubmed/38032725 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45128 %T User-Guided Enhancements to a Technology-Facilitated Resilience Program to Address Opioid Risks Following Traumatic Injury in Youth: Qualitative Interview Study %A Adams,Zachary W %A Marriott,Brigid R %A Karra,Swathi %A Linhart-Musikant,Elizabeth %A Raymond,Jodi L %A Fischer,Lydia J %A Bixler,Kristina A %A Bell,Teresa M %A Bryan,Eric A %A Hulvershorn,Leslie A %+ Department of Psychiatry, Indiana University School of Medicine, 410 West 10th Street, Indianapolis, IN, 46202, United States, 1 3172780591, zwadams@iu.edu %K access-to-care %K addiction %K adolescent %K behavior %K health disorder %K opioid use disorder %K opioid %K personalized care %K telehealth %K telemedicine %K trauma %K user %K youth %D 2023 %7 30.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Youth with traumatic injury experience elevated risk for behavioral health disorders, yet posthospital monitoring of patients’ behavioral health is rare. The Telehealth Resilience and Recovery Program (TRRP), a technology-facilitated and stepped access-to-care program initiated in hospitals and designed to be integrated seamlessly into trauma center operations, is a program that can potentially address this treatment gap. However, the TRRP was originally developed to address this gap for mental health recovery but not substance use. Given the high rates of substance and opioid use disorders among youth with traumatic injury, there is a need to monitor substance use and related symptoms alongside other mental health concerns. Objective: This study aimed to use an iterative, user-guided approach to inform substance use adaptations to TRRP content and procedures. Methods: We conducted individual semistructured interviews with adolescents (aged 12-17 years) and young adults (aged 18-25 years) who were recently discharged from trauma centers (n=20) and health care providers from two level 1 trauma centers (n=15). Interviews inquired about reactions to and recommendations for expanding TRRP content, features, and functionality; factors related to TRRP implementation and acceptability; and current strategies for monitoring patients’ postinjury physical and emotional recovery and opioid and substance use. Interview responses were transcribed and analyzed using thematic analysis to guide new TRRP substance use content and procedures. Results: Themes identified in interviews included gaps in care, task automation, user personalization, privacy concerns, and in-person preferences. Based on these results, a multimedia, web-based mobile education app was developed that included 8 discrete interactive education modules and 6 videos on opioid use disorder, and TRRP procedures were adapted to target opioid and other substance use disorder risk. Substance use adaptations included the development of a set of SMS text messaging–delivered questions that monitor both mental health symptoms and substance use and related symptoms (eg, pain and sleep) and the identification of validated mental health and substance use screening tools to monitor patients’ behavioral health in the months after discharge. Conclusions: Patients and health care providers found the TRRP and its expansion to address substance use acceptable. This iterative, user-guided approach yielded novel content and procedures that will be evaluated in a future trial. %M 38032728 %R 10.2196/45128 %U https://formative.jmir.org/2023/1/e45128 %U https://doi.org/10.2196/45128 %U http://www.ncbi.nlm.nih.gov/pubmed/38032728 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e49257 %T Effects of an Individualized mHealth-Based Intervention on Health Behavior Change and Cardiovascular Risk Among People With Metabolic Syndrome Based on the Behavior Change Wheel: Quasi-Experimental Study %A Chen,Dandan %A Zhang,Hui %A Wu,Jingjie %A Xue,Erxu %A Guo,Pingping %A Tang,Leiwen %A Shao,Jing %A Cui,Nianqi %A Wang,Xiyi %A Chen,Liying %A Ye,Zhihong %+ Nursing Department, Affiliated Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, No.3 East Qingchun Road, Shangcheng district, Hangzhou, 310020, China, 86 13606612119, yezh@zju.edu.cn %K metabolic syndrome %K health behavior %K cardiovascular risk %K mobile health %K behavior change wheel %D 2023 %7 29.11.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Metabolic syndrome (MetS) is a common public health challenge. Health-promoting behaviors such as diet and physical activity are central to preventing and controlling MetS. However, the adoption of diet and physical activity behaviors has always been challenging. An individualized mobile health (mHealth)–based intervention using the Behavior Change Wheel is promising in promoting health behavior change and reducing atherosclerotic cardiovascular disease (ASCVD) risk. However, the effects of this intervention are not well understood among people with MetS in mainland China. Objective: We aimed to evaluate the effects of the individualized mHealth-based intervention using the Behavior Change Wheel on behavior change and ASCVD risk in people with MetS. Methods: We conducted a quasi-experimental, nonrandomized study. Individuals with MetS were recruited from the health promotion center of a tertiary hospital in Zhejiang province, China. The study involved 138 adults with MetS, comprising a control group of 69 participants and an intervention group of 69 participants. All participants received health education regarding diet and physical activity. The intervention group additionally received a 12-week individualized intervention through a WeChat mini program and a telephone follow-up in the sixth week of the intervention. Primary outcomes included diet, physical activity behaviors, and ASCVD risk. Secondary outcomes included diet self-efficacy, physical activity self-efficacy, knowledge of MetS, quality of life, and the quality and efficiency of health management services. The Mann-Whitney U test and Wilcoxon signed rank test were primarily used for data analysis. Data analysis was conducted based on the intention-to-treat principle using SPSS (version 25.0; IBM Corp). Results: Baseline characteristics did not differ between the 2 groups. Compared with the control group, participants in the intervention group showed statistically significant improvements in diet behavior, physical activity behavior, diet self-efficacy, physical activity self-efficacy, knowledge of MetS, physical health, and mental health after a 12-week intervention (P=.04, P=.001, P=.04, P=.04, P=.001, P=.04, P=.04, and P<.05). The intervention group demonstrated a statistically significant improvement in outcomes from pre- to postintervention evaluations (P<.001, P=.03, P<.001, P=.04, P<.001, P<.001, and P<.001). The intervention also led to enhanced health management services and quality. Conclusions: The individualized mHealth-based intervention using the Behavior Change Wheel was effective in promoting diet and physical activity behaviors in patients with MetS. Nurses and other health care professionals may incorporate the intervention into their health promotion programs. %M 38019579 %R 10.2196/49257 %U https://www.jmir.org/2023/1/e49257 %U https://doi.org/10.2196/49257 %U http://www.ncbi.nlm.nih.gov/pubmed/38019579 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e52315 %T Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): Protocol for an Efficacy Trial %A Michaud,Alexis L %A Bice,Briana %A Miklos,Eva %A McCormick,Katherine %A Medeiros-Nancarrow,Cheryl %A Zhou,Eric S %A Recklitis,Christopher J %+ Perini Family Survivors' Center, Dana Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, United States, 1 617 632 3839, christopher_recklitis@dfci.harvard.edu %K insomnia %K cancer survivors %K young adults %K protocol %K coaching %K mood %D 2023 %7 29.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Young adult cancer survivors (YACS) are at elevated risk for chronic insomnia, even years after completing treatment. In addition to potential health consequences, insomnia can interrupt social, educational, and vocational development just as they are trying to “make up” for time lost to cancer. Cognitive behavioral therapy for insomnia (CBTI) is recommended as first-line treatment for insomnia but remains largely unavailable to YACS due to several barriers (ie, shortage of trained providers, geographic limitations, financial limitations). Traditional CBTI has not been adapted to meet YACS’ unique developmental and circadian challenges. To improve availability of effective behavioral insomnia treatment for this population, we developed the Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA), a low-intensity educational intervention delivered virtually online. Objective: In this phase 2 “proof of concept” trial, primary aims are to test the efficacy of STEP-YA to improve insomnia symptoms and mood in YACS and assess the utility of individualized coaching to improve treatment effects. A secondary aim will explore participant variables associated with clinically significant response to STEP-YA. Methods: This 2-arm randomized prospective trial will enroll 74 off-treatment YACS aged 20 years to 39 years with clinically significant insomnia. Each participant completes the STEP-YA intervention in a 1-on-1 synchronous online session led by a trained interventionist following a structured outline. The 90-minute intervention presents educational information on the development of insomnia after cancer and offers specific suggestions for improving insomnia symptoms. During the session, participants review the suggestions and develop a personalized sleep action plan for implementing them. After the session, participants are randomized to either the coaching condition, in which they receive 2 telephone coaching sessions, or the no-coaching condition, which offers no subsequent coaching. The Insomnia Severity Index (ISI) and the Profile of Mood States: Short Form (POMS-SF) are assessed at baseline and 4 and 8 weeks postintervention. Results: Enrollment began in November 2022, with 28 participants currently enrolled. We anticipate recruitment will be completed in 2024. The primary endpoint is a change in ISI score from baseline to 8 weeks postintervention. The secondary endpoint is change in mood symptoms (POMS-SF) from baseline to 8 weeks postintervention. Change scores will be treated as continuous variables. Primary analyses will use ANOVA methods. A within-subjects analysis will examine if the STEP-YA intervention is associated with significant changes in insomnia and mood over time. A 2-way ANOVA will be used to evaluate the utility of coaching sessions to improve treatment effects. Conclusions: Chronic insomnia has significant negative effects on YACS’ medical, educational, and psychological functioning. STEP-YA aims to address their needs; study results will determine if the intervention warrants future effectiveness and dissemination studies and if individualized coaching is necessary for adequate treatment response. Trial Registration: ClinicalTrials.gov NCT05358951: https://clinicaltrials.gov/study/NCT05358951 International Registered Report Identifier (IRRID): DERR1-10.2196/52315 %R 10.2196/52315 %U https://www.researchprotocols.org/2023/1/e52315/ %U https://doi.org/10.2196/52315 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e50029 %T Digital Health Equity and Tailored Health Care Service for People With Disability: User-Centered Design and Usability Study %A Ha,Sandeul %A Ho,Seung Hee %A Bae,Young-Hyeon %A Lee,Minyoung %A Kim,Ju Hee %A Kim,Ju Han %A Lee,Jisan %+ Department of Nursing, Gangneung-Wonju National University, 402 W5 Department of Nursing, Gangneung-Wonju National University,, 150 Namwon-ro, Heungeop-myeon, Wonju, Gangwon State, 26403, Republic of Korea, 82 33 760 8646, saan2mari@gmail.com %K digital health equity %K digital health care service %K COVID-19 %K mobile health %K mHealth %K mobile apps %K needs assessments %K heuristic %K people with disability %K caregivers %K health personnel %K mobile phone %D 2023 %7 28.11.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: As digital health services advance, digital health equity has become a significant concern. However, people with disability and older adults still face health management limitations, particularly in the COVID-19 pandemic. An essential area of investigation is proposing a patient-centered design strategy that uses patient-generated health data (PGHD) to facilitate optimal communication with caregivers and health care service providers. Objective: This study aims to conceptualize, develop, and validate a digitally integrated health care service platform for people with disability, caregivers, and health care professionals, using Internet of Things devices and PGHD to contribute to improving digital health equity. Methods: The methodology consists of 5 stages. First, a collaborative review of the previous app, Daily Healthcare 1.0, was conducted with individuals with disabilities, caregivers, and health care professionals. Secondly, user needs were identified via personas, scenarios, and user interface sketches to shape a user-centered service design. The third stage created an enhanced app that integrated these specifications. In the fourth stage, heuristic evaluations by clinical and app experts paved the way for Daily Healthcare 2.0, now featuring Internet of Things device integration. Conclusively, in the fifth stage, an extensive 2-month usability evaluation was executed with user groups comprising individuals with disabilities using the app and their caregivers. Results: Among the participants, “disability welfare information and related institutional linkage” was the highest priority. Three of the 14 user interface sketches the participants created were related to “providing educational content.” The 11 heuristic evaluation experts identified “focusing on a single task” as a crucial issue and advocated redesigning the home menu to simplify it and integrate detailed menus. Subsequently, the app Daily Healthcare 2.0 was developed, incorporating wearable devices for collecting PGHD and connecting individuals with disabilities, caregivers, and health care professionals. After the 2-month usability evaluation with 27 participants, all participants showed an increase in eHealth literacy, particularly those who used the caregiver app. Relatively older users demonstrated improved scores in health IT usability and smartphone self-efficacy. All users’ satisfaction and willingness to recommend increased, although their willingness to pay decreased. Conclusions: In this study, we underscore the significance of incorporating the distinct needs of individuals with disabilities, caregivers, and health care professionals from the design phase of a digital health care service, highlighting its potential to advance digital health equity. Our findings also elucidate the potential benefits of fostering partnerships between health consumers and providers, thereby attenuating the vulnerability of marginalized groups, even amid crises such as the COVID-19 pandemic. Emphasizing this imperative, we advocate for sustained endeavors to bolster the digital literacy of individuals with disabilities and champion collaborative cocreation, aiming to uphold the collective ethos of health and digital health equity. %M 38015589 %R 10.2196/50029 %U https://www.jmir.org/2023/1/e50029 %U https://doi.org/10.2196/50029 %U http://www.ncbi.nlm.nih.gov/pubmed/38015589 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 9 %N %P e53602 %T Behavior Change Techniques for the Maintenance of Physical Activity in Cancer %A Edbrooke,Lara %A Jones,Tamara L %+ The University of Melbourne, Level 7, 161 Barry St, Melbourne, 3053, Australia, 61 3 9035 4213, larae@unimelb.edu.au %K cancer %K physical activity %K behavior change %D 2023 %7 28.11.2023 %9 Commentary %J JMIR Cancer %G English %X Ester et al report the findings from a 2-arm cluster randomized controlled trial nested within a hybrid effectiveness-implementation study, which involved a 12-week exercise and behavior change program for rural and remote Canadians (Exercise for Cancer to Enhance Living Well [EXCEL]). The addition of 23 weeks of app-based physical activity monitoring to the EXCEL program did not result in significant between-group differences in physical activity at 6 months. While several behavior change techniques were included in the initial 12-week intervention, additional techniques were embedded within the mobile app. However, there is currently a lack of evidence regarding how many and which behavior change techniques are the most effective for people with cancer and if these differ based on individual characteristics. Potentially, the use of the mobile app was not required in addition to the behavior change support delivered to both groups as part of the EXCEL program. Further research should involve participants who may be in most need of behavioral support, for example, those with lower levels of self-efficacy. Suggestions for future research to tailor behavior change support for people with cancer are discussed. %M 38015601 %R 10.2196/53602 %U https://cancer.jmir.org/2023/1/e53602 %U https://doi.org/10.2196/53602 %U http://www.ncbi.nlm.nih.gov/pubmed/38015601 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e51792 %T Efficacy of mHealth Interventions for Improving Maternal and Neonatal Outcomes Among Pregnant Women With Hypertensive Disorders: Protocol for a Systematic Review %A Noronha,Judith Angelitta %A Lewis,Mitchelle S %A Phagdol,Tenzin %A Nayak,Baby S %A D,Anupama %A Shetty,Jyothi %A N,Ravishankar %A Nair,Sreekumaran %+ Department of Fundamentals of Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Madhav Nagar, Manipal, 576104, India, 91 7259693480, lewis.mitchelle@manipal.edu %K digital health %K gestational hypertension %K hypertension %K hypertensive %K knowledge synthesis %K maternal health outcomes %K maternal %K mHealth %K mobile health application %K mobile health %K neonatal health outcomes %K neonatal %K neonates %K preeclampsia %K pregnancy %K pregnant %K review methodology %K review methods %K SMS %K systematic %K telemedicine %K text messaging %K sustainable development goal %D 2023 %7 28.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Hypertension is one of the most prevalent medical conditions that arise during pregnancy, resulting in maternal and neonatal complications. Mobile health (mHealth) has emerged as an innovative intervention for delivering maternal and child health care services. The evidence on the effectiveness of mHealth interventions in improving the health outcomes of pregnant women with hypertensive disorders is lacking. Therefore, there is a need for evidence synthesis using systematic review methods to address this evidence gap. Objective: This review aims to determine the efficacy of mHealth interventions in improving maternal and neonatal outcomes among pregnant women with hypertensive disorders. The review will answer the following research questions: (1) What are the types of mHealth interventions used in pregnant women with hypertensive disorders? (2) Are the various mHealth interventions effective in improving maternal and neonatal health outcomes, health behaviors, and their knowledge of the disease? and (3) Are mHealth interventions effective in supporting health care providers to make health care decisions for pregnant women with hypertensive disorders? Methods: This review will include randomized controlled trials, nonrandomized controlled trials, and cohort studies focusing on mHealth interventions for pregnant women with hypertensive disorders. Studies reporting health care providers use of mHealth interventions in caring for pregnant women with hypertensive disorders will be included. The search strategy will be tailored to each database using database-specific search terms. The search will be conducted in PubMed-MEDLINE, ProQuest, CINAHL, Scopus, Web of Science, and CENTRAL. Other literature sources, such as trial registries and bibliographies of relevant studies, will be additionally searched. Studies published in English from January 2000 to January 2023 will be included. A total of 2 review authors will independently perform the data extraction and the quality appraisal. For quality appraisal of randomized controlled trials, the Cochrane Risk of Bias 2 tool will be used. The Risk of Bias in Nonrandomized Studies of Interventions (ROBINS-1) tool will be used for nonrandomized controlled trials, and the Critical Appraisal Skills Programme checklist for cohort studies will be used. Any disagreements between the 2 reviewers will be resolved through discussion and a third reviewer if required. A meta-analysis will be performed based on the availability of the data. Results: As per the protocol, the study methodology was followed, and 2 independent reviewers conducted the search in 6 databases and clinical registries. Currently, the review is in the full-text screening stage. The review will publish the results in the first quarter of 2024. Conclusions: The evidence synthesized from this systematic review will help guide future research, support health care decisions, and inform policy makers on the effectiveness of mHealth interventions in improving the maternal and neonatal outcomes of pregnant women with hypertensive disorders. International Registered Report Identifier (IRRID): PRR1-10.2196/51792 %M 38015596 %R 10.2196/51792 %U https://www.researchprotocols.org/2023/1/e51792 %U https://doi.org/10.2196/51792 %U http://www.ncbi.nlm.nih.gov/pubmed/38015596 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e51549 %T Effects and Mechanisms of a Web- and Mobile-Based Acceptance and Commitment Therapy Intervention for Anxiety and Depression Symptoms in Nurses: Fully Decentralized Randomized Controlled Trial %A Lu,Yan'e %A Li,Yang %A Huang,Yongqi %A Zhang,Xuan %A Wang,Juan %A Wu,Liuliu %A Cao,Fenglin %+ Department of Nursing Psychology, School of Nursing and Rehabilitation, Shandong University, 44 Wenhua West Road, Lixia District, Jinan, 250012, China, 86 13065093172, caofenglin2008@126.com %K acceptance and commitment therapy %K anxiety %K depression %K internet-based intervention %K nurse %K randomized controlled trial %D 2023 %7 27.11.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Acceptance and commitment therapy (ACT) is a promising intervention for improving mental health. However, there is limited evidence on its effectiveness for nurses, particularly in web- and mobile-based intervention forms, in mitigating anxiety and depression symptoms. Objective: In this study, we aimed to examine the effect and underlying psychological mechanisms of a web- and mobile-based ACT intervention on nurses’ anxiety and depression symptoms. Methods: In this fully decentralized randomized controlled trial, nurses were recruited nationwide across China through advertisements and posters. They were randomly assigned to either the 5-week fully automated intervention or the waiting group. Primary outcomes (anxiety and depression symptoms); secondary outcomes (sleep quality, burnout, and work performance); and mediators (psychological flexibility, cognitive defusion, mindfulness, and values) were assessed using the Wenjuanxing platform. Data collectors were blinded to the group assignments throughout the study period. Results: A total of 145 nurses with anxiety or depression symptoms were randomly assigned to either the intervention group (n=72, 49.7%) or the control group (n=73, 50.3%); 97.2% (n=141) were female. During the study, 36 (24.8%) nurses were lost to follow-up, and 53 (73.6%) completed the entire intervention. Nurses in the intervention group showed significant improvement in anxiety (d=0.67, 95% CI 0.33-1.00) and depression symptoms (d=0.58, 95% CI 0.25-0.91), and the effects were sustained for 3 months after the intervention (anxiety: d=0.55, 95% CI 0.22-0.89; depression: d=0.66, 95% CI 0.33-1.00). Changes in psychological flexibility, cognitive defusion, and values mediated the effect of the intervention on anxiety and depression symptoms, while mindfulness did not have a mediating effect. Conclusions: The web- and mobile-based ACT intervention used in this study significantly improved nurses’ anxiety and depression symptoms by improving psychological flexibility, cognitive defusion, and values. The results provide new ideas for hospital administrators to prevent and intervene in nurses’ psychological issues. Trial Registration: Chinese Clinical Trial Register ChiCTR2200059218; https://tinyurl.com/4mb4t5y9 %M 38010787 %R 10.2196/51549 %U https://www.jmir.org/2023/1/e51549 %U https://doi.org/10.2196/51549 %U http://www.ncbi.nlm.nih.gov/pubmed/38010787 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43584 %T Predictors of Dropout Among Psychosomatic Rehabilitation Patients During the COVID-19 Pandemic: Secondary Analysis of a Longitudinal Study of Digital Training %A Gao,Lingling %A Keller,Franziska Maria %A Becker,Petra %A Dahmen,Alina %A Lippke,Sonia %+ Health Psychology and Behavioural Medicine, Constructor University Bremen, Campus Ring 1, Bremen, 28759, Germany, 49 4212004730, slippke@constructor.university %K dropout %K web-based study %K digital therapy %K medical rehabilitation %K digital training %K mental disorder %K psychosomatic rehabilitation %K COVID-19 %D 2023 %7 27.11.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: High dropout rates are a common problem reported in web-based studies. Understanding which risk factors interrelate with dropping out from the studies provides the option to prevent dropout by tailoring effective strategies. Objective: This study aims to contribute an understanding of the predictors of web-based study dropout among psychosomatic rehabilitation patients. We investigated whether sociodemographics, voluntary interventions, physical and mental health, digital use for health and rehabilitation, and COVID-19 pandemic–related variables determine study dropout. Methods: Patients (N=2155) recruited from 4 psychosomatic rehabilitation clinics in Germany filled in a web-based questionnaire at T1, which was before their rehabilitation stay. Approximately half of the patients (1082/2155, 50.21%) dropped out at T2, which was after the rehabilitation stay, before and during which 3 voluntary digital trainings were provided to them. According to the number of trainings that the patients participated in, they were categorized into a comparison group or 1 of 3 intervention groups. Chi-square tests were performed to examine the differences between dropout patients and retained patients in terms of sociodemographic variables and to compare the dropout rate differences between the comparison and intervention groups. Logistic regression analyses were used to assess what factors were related to study dropout. Results: The comparison group had the highest dropout rate of 68.4% (173/253) compared with the intervention groups’ dropout rates of 47.98% (749/1561), 50% (96/192), and 42.9% (64/149). Patients with a diagnosis of combined anxiety and depressive disorder had the highest dropout rate of 64% (47/74). Younger patients (those aged <50 y) and patients who were less educated were more likely to drop out of the study. Patients who used health-related apps and the internet less were more likely to drop out of the study. Patients who remained in their jobs and patients who were infected by COVID-19 were more likely to drop out of the study. Conclusions: This study investigated the predictors of dropout in web-based studies. Different factors such as patient sociodemographics, physical and mental health, digital use, COVID-19 pandemic correlates, and study design can correlate with the dropout rate. For web-based studies with a focus on mental health, it is suggested to consider these possible dropout predictors and take appropriate steps to help patients with a high risk of dropping out overcome difficulties in completing the study. %M 37903289 %R 10.2196/43584 %U https://www.jmir.org/2023/1/e43584 %U https://doi.org/10.2196/43584 %U http://www.ncbi.nlm.nih.gov/pubmed/37903289 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e50072 %T Circadian Reinforcement Therapy in Combination With Electronic Self-Monitoring to Facilitate a Safe Postdischarge Period for Patients With Major Depression: Randomized Controlled Trial %A Aggestrup,Anne Sofie %A Svendsen,Signe Dunker %A Præstegaard,Anne %A Løventoft,Philip %A Nørregaard,Lasse %A Knorr,Ulla %A Dam,Henrik %A Frøkjær,Erik %A Danilenko,Konstantin %A Hageman,Ida %A Faurholt-Jepsen,Maria %A Kessing,Lars Vedel %A Martiny,Klaus %+ Mental Health Centre Copenhagen, Copenhagen University Hospital, Frederiksberg Hospital, Nordre Fasanvej 57, Hovedvejen 17, 1st floor, Frederiksberg, 2000, Denmark, 45 38647102, klaus.martiny@regionh.dk %K major depression %K internet interventions %K self-monitoring %K sleep %K circadian %K chronobiology %K chronotherapy %K clinician assisted %D 2023 %7 27.11.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Patients with major depression exhibit circadian disturbance of sleep and mood, and when they are discharged from inpatient wards, this disturbance poses a risk of relapse. We developed a circadian reinforcement therapy (CRT) intervention to facilitate the transition from the inpatient ward to the home for these patients. CRT focuses on increasing the zeitgeber strength for the circadian clock through social contact, physical activity, diet, daylight exposure, and sleep timing. Objective: In this study, we aimed to prevent the worsening of depression after discharge by using CRT, supported by an electronic self-monitoring system, to advance and stabilize sleep and improve mood. The primary outcome, which was assessed by a blinded rater, was the change in the Hamilton Depression Rating Scale scores from baseline to the end point. Methods: Participants were contacted while in the inpatient ward and randomized 1:1 to the CRT or the treatment-as-usual (TAU) group. For 4 weeks, participants in both groups electronically self-monitored their daily mood, physical activity, sleep, and medication using the Monsenso Daybuilder (MDB) system. The MDB allowed investigators and participants to simultaneously view a graphical display of registrations. An investigator phoned all participants weekly to coinspect data entry. In the CRT group, participants were additionally phoned between the scheduled calls if specific predefined trigger points for mood and sleep were observed during the daily inspection. Participants in the CRT group were provided with specialized CRT psychoeducation sessions immediately after inclusion, focusing on increasing the zeitgeber input to the circadian system; a PowerPoint presentation was presented; paper-based informative materials and leaflets were reviewed with the participants; and the CRT principles were used during all telephone consultations. In the TAU group, phone calls focused on data entry in the MDB system. When discharged, all patients were treated at a specialized affective disorders service. Results: Overall, 103 participants were included. Participants in the CRT group had a significantly larger reduction in Hamilton Depression Scale score (P=.04) than those in the TAU group. The self-monitored MDB data showed significantly improved evening mood (P=.02) and sleep quality (P=.04), earlier sleep onset (P=.009), and longer sleep duration (P=.005) in the CRT group than in the TAU group. The day-to-day variability of the daily and evening mood, sleep offset, sleep onset, and sleep quality were significantly lower in the CRT group (all P<.001) than in the TAU group. The user evaluation was positive for the CRT method and the MDB system. Conclusions: We found significantly lower depression levels and improved sleep quality in the CRT group than in the TAU group. We also found significantly lower day-to-day variability in daily sleep, mood parameters, and activity parameters in the CRT group than in the TAU group. The delivery of the CRT intervention should be further refined and tested. Trial Registration: ClinicalTrials.gov NCT02679768; https://clinicaltrials.gov/study/NCT02679768 International Registered Report Identifier (IRRID): RR2-10.1186/s12888-019-2101-z %M 37800194 %R 10.2196/50072 %U https://mental.jmir.org/2023/1/e50072 %U https://doi.org/10.2196/50072 %U http://www.ncbi.nlm.nih.gov/pubmed/37800194 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 9 %N %P e42123 %T Recruitment of Patients With Cancer for a Clinical Trial Evaluating a Web-Based Psycho-Oncological Intervention: Secondary Analysis of a Diversified Recruitment Strategy in a Randomized Controlled Trial %A Tsiouris,Angeliki %A Mayer,Anna %A Wiltink,Jörg %A Ruckes,Christian %A Beutel,Manfred E %A Zwerenz,Rüdiger %+ Department of Psychosomatic Medicine and Psychotherapy, University Medical Center of the Johannes Gutenberg-University Mainz, Untere Zahlbacher Str. 8, Mainz, 55131, Germany, 49 6131175981, ruediger.zwerenz@unimedizin-mainz.de %K psycho-oncology %K cancer %K recruitment %K social media %K web-based interventions %K web-based recruitment %D 2023 %7 27.11.2023 %9 Original Paper %J JMIR Cancer %G English %X Background: Participant recruitment poses challenges in psycho-oncological intervention research, such as psycho-oncological web-based intervention studies. Strict consecutive recruitment in clinical settings provides important methodological benefits but is often associated with low response rates and reduced practicability and ecological validity. In addition to preexisting recruitment barriers, the protective measures owing to the COVID-19 pandemic restricted recruitment activities in the clinical setting since March 2020. Objective: This study aims to outline the recruitment strategy for a randomized controlled trial evaluating the unguided emotion-based psycho-oncological online self-help (epos), which combined traditional and web-based recruitment. Methods: We developed a combined recruitment strategy including traditional (eg, recruitment in clinics, medical practices, cancer counseling centers, and newspapers) and web-based recruitment (Instagram, Facebook, and web pages). Recruitment was conducted between May 2020 and September 2021. Eligible participants for this study were adult patients with any type of cancer who were currently receiving treatment or in posttreatment care. They were also required to have a good command of the German language and access to a device suitable for web-based interventions, such as a laptop or computer. Results: We analyzed data from 304 participants who were enrolled in a 17-month recruitment period using various recruitment strategies. Web-based and traditional recruitment strategies led to comparable numbers of participants (151/304, 49.7% vs 153/304, 50.3%). However, web-based recruitment required much less effort. Regardless of the recruitment strategy, the total sample did not accurately represent patients with cancer currently undergoing treatment for major types of cancer in terms of various sociodemographic characteristics, including but not limited to sex and age. However, among the web-recruited study participants, the proportion of female participants was even higher (P<.001), the mean age was lower (P=.005), private internet use was higher (on weekdays: P=.007; on weekends: P=.02), and the number of those who were currently under treatment was higher (P=.048). Other demographic and medical characteristics revealed no significant differences between the groups. The majority of participants registered as self-referred (236/296, 79.7%) instead of having followed the recommendation of or study invitation from a health care professional. Conclusions: The combined recruitment strategy helped overcome general and COVID-19–specific recruitment barriers and provided the targeted participant number. Social media recruitment was the most efficient individual recruitment strategy for participant enrollment. Differences in some demographic and medical characteristics emerged, which should be considered in future analyses. Implications and recommendations for social media recruitment based on personal experiences are presented. Trial Registration: German Clinical Trials Register DRKS00021144; https://drks.de/search/en/trial/DRKS00021144 International Registered Report Identifier (IRRID): RR2-10.1016/j.invent.2021.100410 %M 38010774 %R 10.2196/42123 %U https://cancer.jmir.org/2023/1/e42123 %U https://doi.org/10.2196/42123 %U http://www.ncbi.nlm.nih.gov/pubmed/38010774 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43034 %T Effectiveness and Cost-Effectiveness of a Stratified Blended Physiotherapy Intervention Compared With Face-to-Face Physiotherapy in Patients With Nonspecific Low Back Pain: Cluster Randomized Controlled Trial %A Koppenaal,Tjarco %A van Dongen,Johanna M %A Kloek,Corelien JJ %A Arensman,Remco M %A Veenhof,Cindy %A Pisters,Martijn F %A Ostelo,Raymond WJG %+ Research Group Empowering Healthy Behaviour, Department of Health Innovations and Technology, Fontys University of Applied Sciences, Postbus 347, Eindhoven, 5600 AH, Netherlands, 31 653945086, t.koppenaal@fontys.nl %K economic evaluation %K eHealth %K nonspecific low back pain %K physiotherapy %K blended care %K mobile phone %D 2023 %7 24.11.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Nonspecific low back pain (LBP) is a leading contributor to disability worldwide, and its socioeconomic burden is substantial. Self-management support is an important recommendation in clinical guidelines for the physiotherapy treatment of patients with LBP and may support cost-effective management. However, providing adequate individually tailored self-management support is difficult. The integration of web-based applications into face-to-face care (ie, blended care) seems promising to optimize tailored treatment and enhance patients’ self-management and, consequently, may reduce LBP-related costs. Objective: We aimed to evaluate the long-term effectiveness and cost-effectiveness of stratified blended physiotherapy (e-Exercise LBP) compared with face-to-face physiotherapy in patients with nonspecific LBP. Methods: An economic evaluation was conducted alongside a prospective, multicenter, cluster randomized controlled trial in primary care physiotherapy. Patients with nonspecific LBP were treated with either stratified blended physiotherapy (e-Exercise LBP) (n=104) or face-to-face physiotherapy (n=104). The content of both interventions was based on the Dutch physiotherapy guidelines for nonspecific LBP. Blended physiotherapy was stratified according to the patients’ risk of developing persistent LBP using the STarT Back Screening Tool. The primary clinical outcome was physical functioning (Oswestry Disability Index version 2.1a). For the economic evaluation, quality-adjusted life years (QALYs; EQ-5D-5L) and physical functioning were the primary outcomes. Secondary clinical outcomes included fear avoidance beliefs and self-reported adherence. Costs were measured from societal and health care perspectives using self-report questionnaires. Effectiveness was estimated using linear mixed models. Seemingly unrelated regression analyses were conducted to estimate total cost and effect differences for the economic evaluation. Results: Neither clinically relevant nor statistically substantial differences were found between stratified blended physiotherapy and face-to-face physiotherapy regarding physical functioning (mean difference [MD] −1.1, 95% CI −3.9 to 1.7) and QALYs (MD 0.026, 95% CI −0.020 to 0.072) over 12 months. Regarding the secondary outcomes, fear avoidance beliefs showed a statistically significant improvement in favor of stratified blended physiotherapy (MD −4.3, 95% CI −7.3 to −1.3). Societal and health care costs were higher for stratified blended physiotherapy than for face-to-face physiotherapy, but the differences were not statistically significant (societal: €972 [US $1027], 95% CI −€1090 to €3264 [US –$1151 to $3448]; health care: €73 [US $77], 95% CI −€59 to €225 [US –$62 to $238]). Among the disaggregated cost categories, only unpaid productivity costs were significantly higher for stratified blended physiotherapy. From both perspectives, a considerable amount of money must be paid per additional QALY or 1-point improvement in physical functioning to reach a relatively low to moderate probability (ie, 0.23-0.81) of stratified blended physiotherapy being cost-effective compared with face-to-face physiotherapy. Conclusions: The stratified blended physiotherapy intervention e-Exercise LBP is neither more effective for improving physical functioning nor more cost-effective from societal or health care perspectives compared with face-to-face physiotherapy for patients with nonspecific LBP. Trial Registration: ISRCTN 94074203; https://www.isrctn.com/ISRCTN94074203 International Registered Report Identifier (IRRID): RR2-10.1186/s12891-020-3174-z %M 37999947 %R 10.2196/43034 %U https://www.jmir.org/2023/1/e43034 %U https://doi.org/10.2196/43034 %U http://www.ncbi.nlm.nih.gov/pubmed/37999947 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e50516 %T Efficacy of an Internet-Delivered Intervention for Improving Insomnia Severity and Functioning in Veterans: Randomized Controlled Trial %A Nazem,Sarra %A Barnes,Sean M %A Forster,Jeri E %A Hostetter,Trisha A %A Monteith,Lindsey L %A Kramer,Emily B %A Gaeddert,Laurel A %A Brenner,Lisa A %+ Dissemination & Training Division, National Center for Posttraumatic Stress Disorder, 795 Willow Road, Building 334, Menlo Park, CA, 94025, United States, 1 650 796 8208, Sarra.Nazem@va.gov %K cognitive behavioral therapy %K insomnia %K internet intervention %K online intervention %K randomized controlled trial %K RCT %K RCTs %K sleep %K treatment %K veteran %K veterans %K veterans’ health %D 2023 %7 24.11.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Despite a growing evidence base that internet-delivered cognitive behavioral therapy for insomnia (iCBT-I) is associated with decreased insomnia severity, its efficacy has been minimally examined in veterans. Objective: The objective of this study was to evaluate the efficacy of an unguided iCBT-I (Sleep Healthy Using the Internet [SHUTi]) among veterans. Methods: We conducted a single-blind, randomized controlled trial in Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn veterans eligible for Veterans Health Administration care. Participants were randomly assigned (1:1) to receive SHUTi (a self-guided and interactive program) or an Insomnia Education Website (IEW) that provided nontailored and fixed insomnia information. Web-based assessments were administered at baseline, postintervention, 6 months postintervention, and 1 year postintervention. The primary outcome was self-reported insomnia severity (Insomnia Severity Index [ISI]). Secondary outcomes were self-reported mental and physical health functioning (Veterans RAND 36-item Health Survey). Exploratory outcomes comprised sleep diary parameters. Results: Of the 231 randomized participants (mean age 39.3, SD 7.8 years; 170/231, 73.5% male sex; 26/231, 11.3% Black; 172/231, 74.5% White; 10/231, 4.3% multiracial; and 17/231, 7.4% other; 36/231, 15.6% Hispanic) randomized between April 2018 and January 2019, a total of 116 (50.2%) were randomly assigned to SHUTi and 115 (49.8%) to the IEW. In intent-to-treat analyses, SHUTi participants experienced significantly larger ISI decreases compared with IEW participants at all time points (generalized η2 values of 0.13, 0.12, and 0.10, respectively; all P<.0001). These corresponded to estimated larger differences in changes of –3.47 (95% CI –4.78 to –2.16), –3.80 (95% CI –5.34 to –2.27), and –3.42 (95% CI –4.97 to 1.88) points on the ISI for the SHUTi group. SHUTi participants experienced significant improvements in physical (6-month generalized η2=0.04; P=.004) and mental health functioning (6-month and 1-year generalized η2=0.04; P=.009 and P=.005, respectively). Significant sleep parameter improvements were noted for SHUTi (all P<.05), though the pattern and magnitude of these reductions varied by parameter. No adverse events were reported. Conclusions: Self-administered iCBT-I was associated with immediate and long-term improvements in insomnia severity. Findings suggest that leveraging technology to meet insomnia treatment demands among veterans may be a promising approach. Trial Registration: ClinicalTrials.gov NCT03366870; https://clinicaltrials.gov/ct2/show/NCT03366870 %M 37999953 %R 10.2196/50516 %U https://mental.jmir.org/2023/1/e50516 %U https://doi.org/10.2196/50516 %U http://www.ncbi.nlm.nih.gov/pubmed/37999953 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e53268 %T A Brief, Digital Music-Based Mindfulness Intervention for Black Americans With Elevated Race-Based Anxiety and Little-to-No Meditation Experience (“healing attempt"): Replication and Extension Study %A Jones,Grant %A Castro-Ramirez,Franchesca %A Al-Suwaidi,Maha %A McGuire,Taylor %A Herrmann,Felipe %+ Department of Psychology, Harvard University, 33 Kirkland Street, Cambridge, MA, 02138, United States, gmj005@g.harvard.edu %K Black music %K mindfulness %K meditation %K music %K song %K psychotherapy %K self-compassion %K ethnic %K cultural %K single-case experiment %K race %K anxiety %K digital health intervention %K Black %K digital health %K low income %K racial disparity %K mental health %D 2023 %7 24.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Race-based anxiety is a critical health issue within the Black community. Mindfulness interventions hold promise for treating race-based anxiety in Black Americans; however, there are many barriers that prevent Black Americans from using these treatments, such as low cultural relevance, significant time burdens, and excessive costs. Objective: This study is a replication and extension of findings that “healing attempt”—a brief (<60-minute), digital, music-based mindfulness intervention—is a feasible and acceptable intervention for race-based anxiety in Black Americans. In this study, we tested this research question among those with little-to-no meditation experience. Methods: The participants were 4 Black American adults with elevated race-based trait anxiety and little-to-no meditation experience. We used a series of multiple-baseline single-case experiments and conducted study visits on Zoom (Zoom Video Communications) to assess whether the intervention can decrease state anxiety and increase mindfulness and self-compassion in Black Americans. We also assessed feasibility and acceptability using quantitative and qualitative scales. Results: In line with our hypotheses, “healing attempt” increased mindfulness/self-compassion (Tau-U range: 0.57-0.86; P<.001) and decreased state anxiety (Tau-U range: –0.93 to –0.66; P<.001), with high feasibility and acceptability (the average likelihood of recommending “healing attempt” was 88 out of 100). Conclusions: “healing attempt” may represent a feasible intervention for race-based anxiety in Black Americans with elevated race-based anxiety and little or no mindfulness experience. Future between-subjects randomized feasibility trials can assess whether the intervention can give rise to lasting improvements in race-based anxiety, mindfulness, and self-compassion. Trial Registration: OSF Registries osf.io/k5m93; https://osf.io/k5m93 %M 37999941 %R 10.2196/53268 %U https://formative.jmir.org/2023/1/e53268 %U https://doi.org/10.2196/53268 %U http://www.ncbi.nlm.nih.gov/pubmed/37999941 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46253 %T Individually Tailored and Culturally Adapted Internet-Based Cognitive Behavioral Therapy for Arabic-Speaking Youths With Mental Health Problems in Sweden: Qualitative Feasibility Study %A Demetry,Youstina %A Wasteson,Elisabet %A Lindegaard,Tomas %A Abuleil,Amjad %A Geranmayeh,Anahita %A Andersson,Gerhard %A Shahnavaz,Shervin %+ Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institute, Norra stationsgatan 69, Stockholm, Sweden, 46 739522332, youstina.demetry@ki.se %K internet-based interventions %K cultural adaptation %K Arabic %K youth %K depression %K anxiety %K refugees %K mental health %K Arabic-speaking youth %K mental disorder %K psychological intervention %D 2023 %7 24.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Most forcibly displaced refugees in Sweden originate from the Arab Republic of Syria and Iraq. Approximately half of all refugees are aged between 15 and 26 years. This particular group of youths is at a higher risk for developing various mental disorders. However, low use of mental health services across Europe has been reported. Previous research indicates that culturally adapted psychological interventions may be suitable for refugee youths. However, little is known about the feasibility, acceptability, and efficacy of such psychological interventions. Objective: This study aimed to explore the feasibility, acceptability, and preliminary efficacy of an individually tailored and culturally adapted internet-based cognitive behavioral therapy for Arabic-speaking refugees and immigrant youths in Sweden. Methods: A total of 17 participants were included to participate in an open trial study of an individually tailored and culturally adapted internet-based cognitive behavioral therapy targeting common mental health problems. To assess the intervention outcome, the Hopkins Symptom Checklist was used. To explore the acceptability of the intervention, in-depth interviews were conducted with 12 participants using thematic analysis. Feasibility was assessed by measuring treatment adherence and by calculating recruitment and retention rates. Results: The intervention had a high dropout rate and low feasibility. Quantitative analyses of the treatment efficacy were not possible because of the high dropout rate. The qualitative analysis resulted in 3 overarching categories: experiences with SahaUng (the treatment), attitudes toward psychological interventions, and personal factors important for adherence. Conclusions: The findings from this study indicate that the feasibility and acceptability of the current intervention were low and, based on the qualitative analysis, could be increased by a refinement of recruitment strategies, further simplification of the treatment content, and modifications to the cultural adaptation. %M 37999955 %R 10.2196/46253 %U https://formative.jmir.org/2023/1/e46253 %U https://doi.org/10.2196/46253 %U http://www.ncbi.nlm.nih.gov/pubmed/37999955 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46927 %T Internet-Delivered Therapy for Parents With Health Anxiety by Proxy: Protocol for a Single-Case Experimental Design Study %A Ingeman,Katrine %A Frostholm,Lisbeth %A Wellnitz,Kaare Bro %A Wright,Kristi %A Frydendal,Ditte Hoffmann %A Onghena,Patrick %A Rask,Charlotte Ulrikka %+ Research Unit, Department of Child and Adolescent Psychiatry, Aarhus University Hospital Psychiatry, Palle Juul-Jensens Boulevard 175, entrence K, Aarhus, 8200, Denmark, 45 20542556, katbec@rm.dk %K health anxiety by proxy %K health anxiety %K internet-delivered treatment %K single-case experimental design %K SCED %K protocol %D 2023 %7 24.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Health anxiety (HA) by proxy is described as parents’ obsessive worries that their child is severely ill although this is not medically confirmed. Research on HA by proxy suggests that it is highly distressing for the parent and that the child may be at risk of developing maladaptive symptom coping strategies. No targeted treatment for this group exists. We developed PROXY, an 8-week psychological internet-delivered treatment for parents with HA by proxy. The treatment components of PROXY are informed by cognitive behavioral therapy as well as acceptance and commitment therapy, and it was developed in collaboration with parents experiencing HA by proxy and clinical experts. Objective: This paper describes the protocol for a study investigating the potential effects of PROXY on parents’ worries about their children’s health using a single-case experimental design (SCED). Methods: Five parents clinically evaluated as experiencing HA by proxy will be included. A replicated randomized SCED study will be conducted in which each participant will be randomized to receive treatment after a baseline period of between 7 and 26 days (phase A). The treatment phase duration is 8 weeks for all participants (phase B), followed by a follow-up phase lasting between 14 and 33 days (phase C), ensuring that all participants remain in the study for 96 days. Participants will report daily anxiety level by SMS text message throughout the study. They will also answer self-report questionnaires, including questions on HA by proxy and own HA, 4 times during the study. Data will be submitted to structured visual analysis to inspect anxiety level, the variability of anxiety, trends, the overlap of data points among phases, when effects occur, and the consistency of data patterns across participants. Furthermore, randomization tests will be conducted for each participant to test the null hypothesis that PROXY will have no effect on participants’ anxiety. Results: The recruitment of parents began in June 2022. As of March 2, 2023, a total of 4 parents have been included in the study. Data collection was expected to cease in April 2023. Conclusions: To the best of our knowledge, this protocol describes the only study of treatment for HA by proxy. As the prevalence of this condition is still unknown, a SCED was chosen because this method allows the inclusion of very few participants while still providing information on effects and treatment courses. Conducting the study with a replicated randomized phase design enables methodologically sound testing despite the inclusion of very few participants. The results will inform researchers on individual treatment courses and effects, which may direct future research in terms of the possible mechanisms of change, ideas for how to refine the treatment content, and how the treatment may be offered to patients in the future. Trial Registration: ClinicalTrials.gov NCT04830605; https://clinicaltrials.gov/study/NCT04830605 International Registered Report Identifier (IRRID): DERR1-10.2196/46927 %M 37999936 %R 10.2196/46927 %U https://www.researchprotocols.org/2023/1/e46927 %U https://doi.org/10.2196/46927 %U http://www.ncbi.nlm.nih.gov/pubmed/37999936 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e48926 %T A Digital Single-Session Intervention (Project Engage) to Address Fear of Negative Evaluation Among College Students: Pilot Randomized Controlled Trial %A Ghosh,Arka %A Cohen,Katherine A %A Jans,Laura %A Busch,Carly A %A McDanal,Riley %A Yang,Yuanyuan %A Cooper,Katelyn M %A Schleider,Jessica L %+ Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, 625 N Michigan Ave, 21st Fl, Chicago, IL, 60611, United States, 1 3125033403, arka.ghosh@northwestern.edu %K single-session intervention %K fear of negative evaluation %K active learning course %K pilot randomized controlled trial %K intervention %K college student %K science course %K active learning %K negative evaluation %D 2023 %7 23.11.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Increasingly, college science courses are transitioning from a traditional lecture format to active learning because students learn more and fail less frequently when they engage in their learning through activities and discussions in class. Fear of negative evaluation (FNE), defined as a student’s sense of dread associated with being unfavorably evaluated while participating in a social situation, discourages undergraduates from participating in small group discussions, whole class discussions, and conversing one-on-one with instructors. Objective: This study aims to evaluate the acceptability of a novel digital single-session intervention and to assess the feasibility of implementing it in a large enrollment college science course taught in an active learning way. Methods: To equip undergraduates with skills to cope with FNE and bolster their confidence, clinical psychologists and biology education researchers developed Project Engage, a digital, self-guided single-session intervention for college students. It teaches students strategies for coping with FNE to bolster their confidence. Project Engage provides biologically informed psychoeducation, uses interactive elements for engagement, and helps generate a personalized action plan. We conducted a 2-armed randomized controlled trial to evaluate the acceptability and the preliminary effectiveness of Project Engage compared with an active control condition that provides information on available resources on the college campus. Results: In a study of 282 upper-level physiology students, participants randomized to complete Project Engage reported a greater increase in overall confidence in engaging in small group discussions (P=.01) and whole class discussions (P<.001), but not in one-on-one interactions with instructors (P=.05), from baseline to immediately after intervention outcomes, compared with participants in an active control condition. Project Engage received a good acceptability rating (1.22 on a scale of –2 to +2) and had a high completion rate (>97%). Conclusions: This study provides a foundation for a freely available, easily accessible intervention to bolster student confidence for contributing in class. Trial Registration: OSF Registries osf.io/4ca68 http://osf.io/4ca68 %M 37995114 %R 10.2196/48926 %U https://mental.jmir.org/2023/1/e48926 %U https://doi.org/10.2196/48926 %U http://www.ncbi.nlm.nih.gov/pubmed/37995114 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 6 %N %P e44425 %T Within-Person Associations of Accelerometer-Assessed Physical Activity With Time-Varying Determinants in Older Adults: Time-Based Ecological Momentary Assessment Study %A Maes,Iris %A Mertens,Lieze %A Poppe,Louise %A Vetrovsky,Tomas %A Crombez,Geert %A De Backere,Femke %A Brondeel,Ruben %A Van Dyck,Delfien %+ Department of Movement and Sports Sciences, Ghent University, Watersportlaan 2, Ghent, 9000, Belgium, 32 9 264 63 63, iris.maes@ugent.be %K ecological momentary assessment %K EMA %K associations %K emotions %K physical concerns %K intention %K self-efficacy %K older adult %K mobile phone %D 2023 %7 23.11.2023 %9 Original Paper %J JMIR Aging %G English %X Background: Despite the availability of physical activity (PA) interventions, many older adults are still not active enough. This might be partially explained by the often-limited effects of PA interventions. In general, health behavior change interventions often do not focus on contextual and time-varying determinants, which may limit their effectiveness. However, before the dynamic tailoring of interventions can be developed, one should know which time-dependent determinants are associated with PA and how strong these associations are. Objective: The aim of this study was to examine within-person associations between multiple determinants of the capability, opportunity, motivation, and behavior framework assessed using Ecological Momentary Assessment (EMA) and accelerometer-assessed light PA, moderate to vigorous PA, and total PA performed at 15, 30, 60, and 120 minutes after the EMA trigger. Methods: Observational data were collected from 64 healthy older adults (36/64, 56% men; mean age 72.1, SD 5.6 y). Participants were asked to answer a time-based EMA questionnaire 6 times per day that assessed emotions (ie, relaxation, satisfaction, irritation, and feeling down), the physical complaint fatigue, intention, intention, and self-efficacy. An Axivity AX3 was wrist worn to capture the participants’ PA. Multilevel regression analyses in R were performed to examine these within-person associations. Results: Irritation, feeling down, intention, and self-efficacy were positively associated with subsequent light PA or moderate to vigorous PA at 15, 30, 60, or 120 minutes after the trigger, whereas relaxation, satisfaction, and fatigue were negatively associated. Conclusions: Multiple associations were observed in this study. This knowledge in combination with the time dependency of the determinants is valuable information for future interventions so that suggestions to be active can be provided when the older adult is most receptive. %M 37995131 %R 10.2196/44425 %U https://aging.jmir.org/2023/1/e44425 %U https://doi.org/10.2196/44425 %U http://www.ncbi.nlm.nih.gov/pubmed/37995131 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e52454 %T Establishing the Need for Anticipatory Symptom Guidance and Networked Models of Disease in Adaptive Family Management Among Children With Medical Complexity: Qualitative Study %A Keim-Malpass,Jessica %A Lunsford,Christopher %A Letzkus,Lisa C %A Scheer,Eleanore %A Valdez,Rupa S %+ Division of Pediatric Hematology-Oncology, Department of Pediatrics, University of Virginia School of Medicine, P.O. Box 800386, Charlottesville, VA, 22901, United States, 1 4349245105, jlk2t@virginia.edu %K anticipatory symptom management %K children with medical complexity %K social network %K qualitative %K self-management %K care coordination %K precision health %K disease progression models %K disability %K networked models of disease %K social networking %K web-based network %K web-based networks %K social networks %K symptom management %K family management %K coordinated care %K precision %K pediatric %K pediatrics %K child %K children %K caregiver %K caregivers %K social support %K interview %K interviews %K family %K informal care %K caregiving %K conceptual %K grounded theory %K constructivist %K situational analysis %K model %K mobile phone %D 2023 %7 23.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Caregivers of children with medical complexity navigate complex family management tasks for their child both in the hospital and home-based setting. The roles and relationships of members of their social network and the dynamic evolution of these family management tasks have been underexamined. Objective: The purpose of this study was to explore the structures and processes of family management among caregivers of children with medical complexity, with a focus on the underlying dynamic nature of family management practices and the role of members of their social network. Methods: This study used a qualitative approach to interview caregivers of children with medical complexity and members of their social network. Caregivers of children with medical complexity were recruited through an academic Children’s Hospital Complex Care Clinic in the mid-Atlantic region and interviewed over a period of 1 to 3 days. Responses were analyzed using constructivist grounded theory and situational analysis to construct a new conceptual model. Only caregiver responses are reported here. Results: In total, 20 caregivers were included in this analysis. Caregiver perspectives revealed the contextual processes that allowed for practices of family management within the setting of rapidly evolving symptoms and health concerns. The dynamic and adaptive nature of this process is a key underlying action supporting this novel conceptual model. The central themes underpinning the adaptive family management model include symptom cues, ongoing surveillance, information gathering, and acute on chronic health concerns. The model also highlights facilitators and threats to successful family management among children with medical complexity and the networked relationship among the structures and processes. Conclusions: The adaptive family management model provides a basis for further quantitative operationalization and study. Previously described self- or family management frameworks do not account for the underlying dynamic nature of the disease trajectory and the developmental stage progression of the child or adolescent, and our work extends existing work. For future work, there is a defined role for technology-enhanced personalized approaches to home-based monitoring. Due to the disparities caregivers and the children in this population already experience, technology-enhanced approaches must be built alongside key stakeholders with an equity orientation to technology co-development. International Registered Report Identifier (IRRID): RR2-10.2196/14810 %M 37801346 %R 10.2196/52454 %U https://formative.jmir.org/2023/1/e52454 %U https://doi.org/10.2196/52454 %U http://www.ncbi.nlm.nih.gov/pubmed/37801346 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e34232 %T Biofeedback and Digitalized Motivational Interviewing to Increase Daily Physical Activity: Series of Factorial N-of-1 Randomized Controlled Trials Piloting the Precious App %A Nurmi,Johanna %A Knittle,Keegan %A Naughton,Felix %A Sutton,Stephen %A Ginchev,Todor %A Khattak,Fida %A Castellano-Tejedor,Carmina %A Lusilla-Palacios,Pilar %A Ravaja,Niklas %A Haukkala,Ari %+ Faculty of Sport and Health Sciences, University of Jyväskylä, PO Box 35, L363, Jyväskylä, 40014, Finland, 358 504698252, keegan.p.knittle@jyu.fi %K smartphone %K daily steps %K activity tracker %K activity bracelet %K motivational interviewing %K self-efficacy %K self-regulation %K biofeedback %K N-of-1 %K automated %K digitalized %K behavior change %K intervention %K ecological momentary assessment %K within-person design %K intensive longitudinal multilevel modeling %K mobile phone %D 2023 %7 23.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Insufficient physical activity is a public health concern. New technologies may improve physical activity levels and enable the identification of its predictors with high accuracy. The Precious smartphone app was developed to investigate the effect of specific modular intervention elements on physical activity and examine theory-based predictors within individuals. Objective: This study pilot-tested a fully automated factorial N-of-1 randomized controlled trial (RCT) with the Precious app and examined whether digitalized motivational interviewing (dMI) and heart rate variability–based biofeedback features increased objectively recorded steps. The secondary aim was to assess whether daily self-efficacy and motivation predicted within-person variability in daily steps. Methods: In total, 15 adults recruited from newspaper advertisements participated in a 40-day factorial N-of-1 RCT. They installed 2 study apps on their phones: one to receive intervention elements and one to collect ecological momentary assessment (EMA) data on self-efficacy, motivation, perceived barriers, pain, and illness. Steps were tracked using Xiaomi Mi Band activity bracelets. The factorial design included seven 2-day biofeedback interventions with a Firstbeat Bodyguard 2 (Firstbeat Technologies Ltd) heart rate variability sensor, seven 2-day dMI interventions, a wash-out day after each intervention, and 11 control days. EMA questions were sent twice per day. The effects of self-efficacy, motivation, and the interventions on subsequent steps were analyzed using within-person dynamic regression models and aggregated data using longitudinal multilevel modeling (level 1: daily observations; level 2: participants). The analyses were adjusted for covariates (ie, within- and between-person perceived barriers, pain or illness, time trends, and recurring events). Results: All participants completed the study, and adherence to activity bracelets and EMA measurements was high. The implementation of the factorial design was successful, with the dMI features used, on average, 5.1 (SD 1.0) times of the 7 available interventions. Biofeedback interventions were used, on average, 5.7 (SD 1.4) times out of 7, although 3 participants used this feature a day later than suggested and 1 did not use it at all. Neither within- nor between-person analyses revealed significant intervention effects on step counts. Self-efficacy predicted steps in 27% (4/15) of the participants. Motivation predicted steps in 20% (3/15) of the participants. Aggregated data showed significant group-level effects of day-level self-efficacy (B=0.462; P<.001), motivation (B=0.390; P<.001), and pain or illness (B=−1524; P<.001) on daily steps. Conclusions: The automated factorial N-of-1 trial with the Precious app was mostly feasible and acceptable, especially the automated delivery of the dMI components, whereas self-conducted biofeedback measurements were more difficult to time correctly. The findings suggest that changes in self-efficacy and motivation may have same-day effects on physical activity, but the effects vary across individuals. This study provides recommendations based on the lessons learned on the implementation of factorial N-of-1 RCTs. %M 37995122 %R 10.2196/34232 %U https://formative.jmir.org/2023/1/e34232 %U https://doi.org/10.2196/34232 %U http://www.ncbi.nlm.nih.gov/pubmed/37995122 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e33147 %T CareKnowDo—A Multichannel Digital and Telephone Support Program for People With Chronic Kidney Disease: Feasibility Randomized Controlled Trial %A Reston,Riley Elizabeth %A Caskey,Fergus J %A Hole,Barnaby %A Udayaraj,Udaya %A Weinman,John %+ Atlantis Health, 1st Floor, Building 3, 566 Chiswick High Road, London, W4 5YA, United Kingdom, 44 7727735151, riley.reston@atlantishealth.com %K kidney disease %K chronic %K blood pressure %K randomized controlled trial %K telemedicine %K mobile health %K mHealth %K self-management %K guideline adherence %K medication adherence %K illness beliefs %K medication beliefs %K health psychology %K preventative medicine %K qualitative research %D 2023 %7 23.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Chronic kidney disease (CKD) is a common, progressive condition. Lifestyle changes and antihypertensive medication can slow the progression to end-stage kidney disease, which requires renal replacement therapy. However, adherence to these recommendations is often low. Objective: The aim of CareKnowDo was to assess the feasibility of rolling out a digital self-management support and adherence program integrated with a patient-facing electronic health record, Patient View (PV). Methods: A 2-arm, parallel, individual-level pragmatic feasibility pilot randomized controlled trial was conducted at 2 National Health Service (NHS) sites in the United Kingdom. A total of 61 patients with CKD were randomized 1:1 into 2 groups and provided with either a new, tailored digital and telephone support program (CareKnowDo: 31/61, 51%) integrated with PV or standard care (PV alone: 30/61, 49%). Quantitative measures included clinical and psychosocial measures. The primary outcomes were feasibility based: recruitment rate, dropout, and the exploration of associations. Results: Of the 1392 patients screened in local kidney clinics, 269 (19.32%) met the basic inclusion criteria; the first 22.7% (61/269) who met the eligibility criteria were recruited to participate in the study. Of the 69 patients, 23 (38%) patients completed the final 6-month follow-up web-based survey. Reasons for the attrition were explored. A higher belief in the ability of the treatment to control CKD was associated with lower blood pressure at baseline (r=0.52; P=.005), and a higher perceived understanding of CKD at baseline was associated with lower blood pressure at follow-up (r=0.66; P<.001). Beliefs about medicines at baseline were associated with blood pressure at baseline but not at follow-up. This was true for both concerns about medicines (r=0.58; P=.001) and perceived necessity of medicines (r=0.42; P=.03). Conclusions: A tailored digital and nurse call–based program to enhance support for patients with CKD was piloted in 2 NHS sites and found to be feasible and acceptable. However, to maximize the effectiveness of the intervention (and of future trials), consideration should be given to the target audience most likely to benefit, as well as how to help them access the program as quickly and easily as possible. Trial Registration: NHS Health Research Authority, IRAS ID 184206; https://www.hra.nhs.uk/planning-and-improving -research/application-summaries/research-summaries/careknowdo-pilot-version-1/ %M 37995117 %R 10.2196/33147 %U https://formative.jmir.org/2023/1/e33147 %U https://doi.org/10.2196/33147 %U http://www.ncbi.nlm.nih.gov/pubmed/37995117 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e44849 %T The Usefulness of Web-Based Communication Data for Social Network Health Interventions: Agent-Based Modeling Study %A Blok,David J %A Simoski,Bojan %A van Woudenberg,Thabo J %A Buijzen,Moniek %+ Erasmus School of Social and Behavioural Sciences, Erasmus University Rotterdam, Burgemeester Oudlaan 50, Rotterdam, 3062 PA, Netherlands, 31 107546208, d.j.blok@essb.eur.nl %K agent-based modeling %K peer nomination network data %K physical activity %K social network analysis %K social network interventions %K web-based communication network data %D 2023 %7 22.11.2023 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Social network interventions are an effective approach to promote physical activity. These interventions are traditionally designed using self-reported peer nomination network data to represent social connections. However, there is unexplored potential in communication data exchanged through web-based messaging apps or social platforms, given the availability of these data, the developments in artificial intelligence to analyze these data, and the shift of personal communication to the web sphere. The implications of using web-based versus offline social networks on the effectiveness of social network interventions remain largely unexplored. Objective: This study aims to investigate the differences in the impact of social network interventions on physical activity levels (PALs) between networks derived from web-based communication and peer nomination data. Methods: We used the data on sociometric questionnaires, messages from a web-based communication app, and PAL (number of steps per day) of 408 participants in 21 school classes. We applied social network analysis to identify influential peers and agent-based modeling to simulate the diffusion of PAL and explore the impact of social network interventions on PAL among adolescents in school classes. Influential peers (n=63) were selected based on centrality measures (ie, in-degree, closeness, and betweenness) to spread the intervention. They received health education, which increased their PAL by 17%. In sensitivity analyses, we tested the impact of a 5%, 10%, and 20% increase in PAL among influential peers. Results: There was a 24%-27% overlap in selected influential peers between the 2 network representations. In general, the simulations showed that interventions could increase PAL by 5.0%-5.8% within 2 months. However, the predicted median impact on PAL was slightly higher in networks based on web-based communication data than peer nomination data for in-degree (5.7%, IQR 5.5%-6.1% vs 5.5%, IQR 5.2%-5.8%; P=.002), betweenness (5.6%, IQR 5.4%-5.9% vs 5.0%, IQR 4.7%-5.3%; P<.001), and closeness centrality (5.8%, IQR 5.6%-6.1% vs 5.3%, IQR 5.0%-5.6%; P<.001). A large variation in impact was observed between school classes (range 1.5%-17.5%). Lowering the effectiveness of health education from 17% to 5% would reduce the overall impact of the social network intervention by 3-fold in both networks. Conclusions: Our findings showed that network interventions based on web-based communication data could increase PAL. Web-based communication data may therefore be a valuable addition to peer nomination data for future social network intervention design. Artificial intelligence methods, including agent-based modeling, can help to design these network interventions and provide insights into the role of network characteristics in their effectiveness. %M 37991813 %R 10.2196/44849 %U https://pediatrics.jmir.org/2023/1/e44849 %U https://doi.org/10.2196/44849 %U http://www.ncbi.nlm.nih.gov/pubmed/37991813 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e52336 %T Investigating the Feasibility, Acceptability, and Appropriation of a Socially Assistive Robot Among Minority Youth at Risk of Self-Harm: Results of 2 Mixed Methods Pilot Studies %A Williams,A Jess %A Townsend,Ellen %A Naeche,Nkem %A Chapman-Nisar,Amelia %A Hollis,Chris %A Slovak,Petr %A , %+ Department of Informatics, King's College London, 30 Aldwych, Bush House, Strand Campus, London, WC2B 4BG, United Kingdom, 44 020 7848 1988, amy_jess.williams@kcl.ac.uk %K digital intervention %K self-harm %K young people %K emotion regulation %K experience sampling %K interviews %D 2023 %7 22.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Minority youth are at an increased risk of experiencing self-harmful thoughts and behaviors. However, there is limited evidence of successful interventions to support young people in the moment of their distress. Digital interventions are considered a potential solution for providing in-the-moment support for those at risk of adverse mental health and self-harm. Objective: These pilot studies aim to investigate the feasibility and acceptability of a new in situ intervention tool, Purrble, among two broad groups of minority youth: (1) lesbian, gay, bisexual, transgender, queer, and similar minority (LGBTQ+) youth and (2) racial and ethnic minority youth. Purrble was designed to support in-situ emotion regulation (ER) support when individuals are facing emotionally challenging situations. Methods: This study consisted of 2 mixed methods pilot studies that followed the same mixed methods design, including 3 weeks of daily and weekly surveys and optional follow-up interviews. Inclusion criteria were (1) aged between 16 and 25 years, (2) part of a minority group, (3) had experiences of self-harmful thoughts or behaviors or elevated symptoms of depression or anxiety, and (4) living in the United Kingdom at the time of the study. The primary outcomes were (1) the feasibility of Purrble as an intervention among pilot samples (analyzed by consent rate, retention rate, adherence to surveys, and engagement with the device) and (2) the acceptability and appropriation of Purrble across pilot studies as a tool to support ER in situ (thematically analyzed qualitative open-ended questions and interview data). The secondary outcomes were descriptive pilot data concerning the mental health outcomes in each sample. Results: In total, 21 LGBTQ+ young people participated in pilot study 1, with 86% (n=18) completing the baseline and 3 weeks of daily surveys. These young people maintained engagement with Purrble across deployment, across which period there was a decrease in self-harmful thoughts and anxiety symptoms. A total of 19 ethnic and racial minority youths participated in pilot study 2, and 84% (n=16) completed the study. Although pilot study 2 participants also maintained engagement with Purrble across deployment, this was to a lesser degree than participants of pilot study 1, and perceived mental health outcomes did not indicate potential change associated with the device. The thematic analysis indicated three superordinate themes: (1) stopping the self-harm cycle, (2) adopting ER strategies, and (3) stages of change. Conclusions: These were the first pilot studies of a novel intervention that aimed to provide in situ ER support for young people at risk of self-harm. Both quantitative and qualitative findings indicate that young people found Purrble to be a feasible and acceptable intervention, as they effectively incorporated the device into their ER practices. These engagements with Purrble were described as interrupting the cycle of self-harmful ideation and behavior. %M 37991838 %R 10.2196/52336 %U https://formative.jmir.org/2023/1/e52336 %U https://doi.org/10.2196/52336 %U http://www.ncbi.nlm.nih.gov/pubmed/37991838 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43260 %T Self-Guided Digital Intervention for Depression in Adolescents: Feasibility and Preliminary Efficacy Study %A Miller,Ian %A Peake,Emily %A Strauss,Gabriel %A Vierra,Elise %A Koepsell,Xin %A Shalchi,Brandon %A Padmanabhan,Aarthi %A Lake,Jessica %+ Big Health Inc, 461 Bush St #200, San Francisco, CA, 94108, United States, 1 415 971 2900, jessica.lake@bighealth.com %K depression %K adolescents %K young adults %K cognitive behavioral therapy %K behavioral activation %K digital health %K mobile interventions %K mobile phone %D 2023 %7 22.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Depression in adolescents is a large and growing problem; however, access to effective mental health care continues to be a challenge. Digitally based interventions may serve to bridge this access gap for adolescents in need of care. Digital interventions that deliver components of cognitive behavioral therapy (CBT) have been shown to reduce symptoms of depression, and virtual reality (VR) may be a promising adjunctive component. However, research on these types of treatments in adolescents and young adults is limited. Objective: This study aims to evaluate the feasibility, acceptability, and preliminary efficacy of Spark (v1.0), a 5-week, self-guided, CBT-based digital program using a mobile app and VR experiences to target symptoms of depression in adolescents. Methods: A single-arm, open-label study of the Spark program was conducted with a community sample of 30 adolescents and young adults aged 12 to 21 years with self-reported moderate to severe depression symptoms. Participants completed a weekly depression assessment (Patient Health Questionnaire-8) in the app during the 5-week intervention period as well as web-based baseline, postintervention, and 1-month follow-up self-report assessments. The participants also completed a qualitative postintervention interview. For participants aged <18 years, caregivers completed assessments at baseline and postintervention time points. Feasibility outcomes included recruitment rate (the proportion of participants who enrolled in the study divided by the total number of participants screened for eligibility) and retention rate (the proportion of participants who completed postintervention assessments divided by the total number of participants who received the intervention). Acceptability outcomes included engagement with the program and quantitative and qualitative feedback about the program. Preliminary efficacy was evaluated based on the Patient Health Questionnaire-8. Results: The study recruitment (31/66, 47%) and retention (29/30, 97%) rates were high. Participants provided higher ratings for the ease of use of the Spark program (8.76 out of 10) and their enjoyment of both the mobile app (7.00 out of 10) and VR components (7.48 out of 10) of the program, whereas they provided lower ratings for the program’s ability to improve mood (4.38 out of 10) or fit into their daily routines (5.69 out of 10). We observed a clinically and statistically significant reduction in depression scores at postintervention (mean difference 5.36; P<.001) and 1-month follow-up (mean difference 6.44; P<.001) time points. Conclusions: The Spark program was found to be a feasible and acceptable way to deliver a self-guided CBT-focused intervention to adolescents and young adults with symptoms of depression. Preliminary data also indicated that the Spark program reduced the symptoms of depression in adolescents and young adults. Future studies should evaluate the efficacy of this intervention in an adequately powered randomized controlled trial. Trial Registration: ClinicalTrials.gov NCT04165681; https://classic.clinicaltrials.gov/ct2/show/NCT04165681 %M 37991839 %R 10.2196/43260 %U https://formative.jmir.org/2023/1/e43260 %U https://doi.org/10.2196/43260 %U http://www.ncbi.nlm.nih.gov/pubmed/37991839 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e51459 %T Effectiveness of Technology-Based Interventions for School-Age Children With Attention-Deficit/Hyperactivity Disorder: Systematic Review and Meta-Analysis of Randomized Controlled Trials %A Wong,Ka Po %A Qin,Jing %A Xie,Yao Jie %A Zhang,Bohan %+ Department of Applied Social Sciences, The Hong Kong Polytechnic University, 11 Yuk Choi Road, Hong Kong, China (Hong Kong), 852 64860214, portia.wong@polyu.edu.hk %K attention-deficit/hyperactivity disorder %K school-age children %K computer-assisted training program %K ADHD %K neurofeedback training %K virtual reality %K cognitive functions %D 2023 %7 21.11.2023 %9 Review %J JMIR Ment Health %G English %X Background: Attention-deficit/hyperactivity disorder (ADHD) is relatively common among school-age children. Technology-based interventions, such as computer-assisted training programs, neurofeedback training, and virtual reality, show promise in regulating the behaviors and cognitive functions of children with ADHD. An increasing number of randomized controlled trials have been conducted to evaluate the effectiveness of these technologies in improving the conditions of children with ADHD. Objective: This study aims to conduct a systematic review of technological interventions for school-age children with ADHD and perform a meta-analysis of the outcomes of technology-based interventions. Methods: A total of 19 randomized controlled studies involving 1843 participants were selected from a pool of 2404 articles across 7 electronic databases spanning from their inception to April 2022. ADHD behaviors, cognitive functions, learning ability, and quality of life were addressed in this study. Results: Random effects meta-analyses found that children with ADHD receiving technology-based intervention showed small and significant effect sizes in computer-rated inattention (standardized mean difference [SMD] −0.35; P<.04), parent-rated overall executive function measured by the Behavior Rating Inventory of Executive Function (SMD −0.35; P<.04), parent-rated disruptive behavior disorder measured by the Child Behavior Checklist (SMD −0.50; P<.001) and Disruptive Behavior Disorder Rating Scale (SMD −0.31; P<.02), and computer-rated visual attention measured by the Continuous Performance Test (SMD −0.42; P<.001) and Reaction Time (SMD −0.43; P<.02). Conclusions: Technology-based interventions are promising treatments for improving certain ADHD behaviors and cognitive functions among school-age children with ADHD. Trial Registration: PROSPERO CRD42023446924; https://tinyurl.com/7ee5t24n %M 37988139 %R 10.2196/51459 %U https://mental.jmir.org/2023/1/e51459 %U https://doi.org/10.2196/51459 %U http://www.ncbi.nlm.nih.gov/pubmed/37988139 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e47463 %T The Effect of Interactivity, Tailoring, and Use Intensity on the Effectiveness of an Internet-Based Smoking Cessation Intervention Over a 12-Month Period: Randomized Controlled Trial %A Maiwald,Phillip %A Bischoff,Martina %A Lindinger,Peter %A Tinsel,Iris %A Sehlbrede,Matthias %A Fichtner,Urs Alexander %A Metzner,Gloria %A Schlett,Christian %A Farin-Glattacker,Erik %+ Institute of Medical Biometry and Statistics, Section of Health Care Research and Rehabilitation Research, Faculty of Medicine and Medical Center, University of Freiburg, Hugstetter Straße 49, Freiburg, 79106, Germany, 49 761 270 72461, martina.bischoff@uniklinik-freiburg.de %K eHealth %K internet-based %K smoking cessation %K interactivity %K tailoring %K use intensity %K randomized controlled trial %K mobile phone %D 2023 %7 21.11.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: eHealth approaches show promising results for smoking cessation (SC). They can improve quit rates, but rigorous research is sparse regarding their effectiveness and the effects of their interactivity, tailoring, and use intensity. Objective: We examined the effectiveness of Techniker Krankenkasse Smoking Cessation Coaching (TK-SCC), an internet-based, tailored, and interactive SC intervention. Our hypotheses were as follows: hypothesis 1, in the intervention group (IG; access to TK-SCC), a clinically relevant number of participants will be abstinent at the 12-month follow-up (T3); hypothesis 2, the number of abstinent participants will be significantly greater in the IG than the control group (CG) at T3; and hypothesis 3, in the IG, more intense use of TK-SCC will be positively associated with abstinence. Methods: Individuals who smoke were randomized into the IG (563/1115, 50.49%) or CG (552/1115, 49.51%), which received a noninteractive, nontailored, and information-only web-based intervention. Data were collected before the intervention, at the postintervention time point (T1), at the 4-month follow-up (T2), and at T3. We tested hypothesis 1 through equivalence tests between the IG’s success rate and success rates of comparable effective interventions reported in 2 current meta-analyses. For hypothesis 2, we conducted binary logistic regressions. For hypothesis 3, we assigned the IG participants to 1 of 4 user types and used binary logistic regressions with user types as the independent variable and smoking abstinence as the dependent variable. Results: In the IG, 11.5% (65/563) and 11.9% (67/563) of participants were smoke free at T1 and T3, respectively. These values were statistically equivalent to the effects in the 2 meta-analyses, which reported 9% (z score=0.64, P=.74) and 10.9% (z score=−0.71, P=.24) success rates, respectively. In the CG, 6.2% (34/552) of the participants were smoke free at T1, which increased up to 8.2% (45/552) at T3. The difference between the IG and CG was statistically significant only at T1 (odds ratio [OR] 2.0, 99% CI 1.1 to 3.6; P=.002), whereas the effect was nonsignificant following α error corrections at T3 (OR 1.6, 99% CI 0.9 to 2.7; P=.02). In the IG, constant users of the program became smoke free significantly more often than rare users of the program (T1: OR 15.0, 99% CI 6.1 to 36.9; P<.001; T3: OR 6.5, 99% CI 2.8 to 15.5; P<.001). Conclusions: TK-SCC is effective for SC. However, its superiority compared with a minimal SC intervention could not be confirmed in the long term. Insufficient implementation of the techniques used and cotreatment bias could explain this outcome. Higher use intensity of TK-SCC was positively related to abstinence. Therefore, additional efforts to motivate users to adhere to intervention use as intended could improve the intervention’s effectiveness. Trial Registration: German Clinical Trials Register DRKS00020249, Universal Trial Number U1111-1245-0273; https://drks.de/search/de/trial/DRKS00020249 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-021-05470-8 %M 37988144 %R 10.2196/47463 %U https://www.jmir.org/2023/1/e47463 %U https://doi.org/10.2196/47463 %U http://www.ncbi.nlm.nih.gov/pubmed/37988144 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e49100 %T Correlation Between Remote Symptom Reporting by Caregivers and Adverse Clinical Outcomes: Mixed Methods Study %A Oakley-Girvan,Ingrid %A Yunis,Reem %A Fonda,Stephanie J %A Longmire,Michelle %A Veuthey,Tess L %A Shieh,Jennifer %A Aghaee,Sara %A Kubo,Ai %A Davis,Sharon W %A Liu,Raymond %A Neeman,Elad %+ Medable Inc, 525 University Ave, Suite A70, Palo Alto, CA, 94103, United States, 1 877 820 6259, oakley@stanford.edu %K adverse events %K cancer %K decentralized clinical trials %K electronic patient-reported outcomes %K ePROs %K mobile health app %K observer-reported outcomes %K Patient-Reported Outcomes Measurement Information System Patient-Reported Outcome Common Terminology Criteria for Adverse Events %K patient-reported outcomes %K PRO-CTCAE %K PROMIS %K remote clinical trials %K remote monitoring %K smartphone %D 2023 %7 21.11.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Timely collection of patient-reported outcomes (PROs) decreases emergency department visits and hospitalizations and increases survival. However, little is known about the outcome predictivity of unpaid informal caregivers’ reporting using similar clinical outcome assessments. Objective: The aim of this study is to assess whether caregivers and adults with cancer adhered to a planned schedule for electronically collecting patient-reported outcomes (PROs) and if PROs were associated with future clinical events. Methods: We developed 2 iPhone apps to collect PROs, one for patients with cancer and another for caregivers. We enrolled 52 patient-caregiver dyads from Kaiser Permanente Northern California in a nonrandomized study. Participants used the apps independently for 4 weeks. Specific clinical events were obtained from the patients’ electronic health records up to 6 months following the study. We used logistic and quasi-Poisson regression analyses to test associations between PROs and clinical events. Results: Participants completed 97% (251/260) of the planned Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) surveys and 98% (254/260) of the Patient-Reported Outcomes Measurement Information System (PROMIS) surveys. PRO-CTCAE surveys completed by caregivers were associated with patients’ hospitalizations or emergency department visits, grade 3-4 treatment-related adverse events, dose reductions (P<.05), and hospice referrals (P=.03). PROMIS surveys completed by caregivers were associated with hospice referrals (P=.02). PRO-CTCAE surveys completed by patients were not associated with any clinical events, but their baseline PROMIS surveys were associated with mortality (P=.03), while their antecedent or final PROMIS surveys were associated with all clinical events examined except for total days of treatment breaks. Conclusions: In this study, caregivers and patients completed PROs using smartphone apps as requested. The association of caregiver PRO-CTCAE surveys with patient clinical events suggests that this is a feasible approach to reducing patient burden in clinical trial data collection and may help provide early information about increasing symptom severity. %M 37988151 %R 10.2196/49100 %U https://www.jmir.org/2023/1/e49100 %U https://doi.org/10.2196/49100 %U http://www.ncbi.nlm.nih.gov/pubmed/37988151 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e47334 %T The Effectiveness of mHealth Interventions Targeting Parents and Youth in Human Papillomavirus Vaccination: Systematic Review %A Ou,Lihong %A Chen,Angela Chia-Chen %A Amresh,Ashish %+ Edson College of Nursing and Health Innovation, Arizona State University, 550 N 3rd St, Phoenix, AZ, 85004, United States, 1 480 253 9098, lihongou@asu.edu %K human papillomavirus %K mobile health %K mHealth %K parents %K systematic review %K vaccination %K youth %K mobile phone %D 2023 %7 21.11.2023 %9 Review %J JMIR Pediatr Parent %G English %X Background: The prevalence of human papillomavirus (HPV) and its related cancers is a major global concern. In the United States, routine HPV vaccination is recommended for youth aged 11 or 12 years. Despite HPV being the most common sexually transmitted infection and the vaccine’s proven efficacy, the vaccination rate among US youth remains below the recommended 80% completion rate. Mobile health (mHealth) interventions have demonstrated promise in improving health. Examining and synthesizing the current evidence about the impact of mHealth interventions on vaccination coverage in youth and intervention characteristics could guide future mHealth interventions aimed at mitigating the vaccination gap and disease burden. Objective: This study aims to conduct a systematic review to assess the effectiveness of mHealth interventions on parental intent to vaccinate youth against HPV and youth’s vaccine uptake. Methods: We searched empirical papers through databases including Google Scholar, PubMed, CINAHL, PsycINFO, and Cochrane Library. The inclusion criteria were the following: (1) published between January 2011 and December 2022; (2) using mHealth aimed to improve HPV vaccination rate; (3) targeted unvaccinated youth or their parents; and (4) measured HPV-related knowledge, vaccination intention, or vaccine uptake. Overall, 3 researchers screened and appraised the quality of the eligible papers using the Melnyk Levels of Evidence and the Cochrane Grading of Recommendations Assessment, Development, and Evaluation methodology. Disagreements in search results and result interpretation were resolved through consensus. Results: Overall, 17 studies that met the inclusion criteria were included in the final review. Most studies were conducted in the United States (14/17, 82%), used a randomized controlled trial design (12/17, 71%), and adopted behavior change theories or a culture-centric approach (10/17, 59%). mHealth interventions included SMS text message reminders, motivational SMS text messages, computer-tailored or tablet-tailored interventions, smartphone apps, web-based tailored interventions, social media (Facebook) campaigns, digital videos, and digital storytelling interventions. Approximately 88% (15/17) of the mHealth interventions demonstrated positive effects on knowledge, intention, or behaviors related to HPV vaccination. Overall, 12% (2/17) reported limited or no intervention impact on vaccine uptake or vaccine series completion. Effective vaccine uptake was commonly seen in interventions based on behavior change theories and those that provided culturally relevant information. Conclusions: This systematic review identified the impact of mHealth interventions among unvaccinated youth and their parents, which showed improvement in HPV-related knowledge, vaccination intention, or vaccine initiation. The interventions that incorporated theories and culture-centric approaches revealed the most promising results. Although these outcomes are encouraging, future studies are needed to investigate factors associated with the success of interventions using SMS text messaging or social media. More studies are also needed for a better understanding of the intervention elements that boost the responses of age-specific and ethnicity-specific populations. %M 37988155 %R 10.2196/47334 %U https://pediatrics.jmir.org/2023/1/e47334 %U https://doi.org/10.2196/47334 %U http://www.ncbi.nlm.nih.gov/pubmed/37988155 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e53874 %T Daily Functioning of Veterans With Type 2 Diabetes: Protocol for an Ambulatory Assessment Study %A Wooldridge,Jennalee S %A Morse,Jessica L %A Delgado,Jorge %A Afari,Niloofar %+ VA San Diego Healthcare System, 3350 La Jolla Village Dr., San Diego, CA, 92161, United States, 1 6194978236, jewooldridge@health.ucsd.edu %K type 2 diabetes mellitus %K ecological momentary assessment %K ambulatory assessment %K intensive longitudinal assessment %K physical activity %K self-management behavior %K functioning %K social support %D 2023 %7 20.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Diabetes impacts nearly 25% of veterans. Many veterans do not engage in recommended physical activity and other diabetes self-management behaviors. Type 2 diabetes is generally asymptomatic; as such, the long-term consequences of inadequate self-management and benefits of consistent self-management are not salient in the short term. Furthermore, self-management behaviors typically take place outside of medical visits; however, self-management–related factors are only assessed during medical visits, likely missing large amounts of variability. Thus, ambulatory assessment methods such as ecological momentary assessment (EMA), accelerometry, and continuous glucose monitoring are needed to understand the dynamics of daily self-management and identify potential intervention targets. Objective: The overarching goal of this study is to understand daily, time-varying factors (comorbid affective symptoms and social context) that influence physical activity, diabetes self-management, glycemic management, daily functioning, and quality of life in participants’ natural environments. Methods: We are recruiting veterans with type 2 diabetes (target N=100). Participants are required to complete a battery of baseline assessments related to mental health, psychosocial factors, and self-management behaviors. Participants then receive 5 momentary EMA surveys and 1 daily EMA survey per day, in which veterans report comorbid affective symptoms (mood, stress, and pain), social support, social interactions, physical activity, and other self-management behaviors. Momentary surveys are delivered randomly during daily preprogrammed intervals over a 14-day sampling period. Accelerometry and continuous glucose monitoring are also used to assess physical activity and blood glucose, respectively. The first 6 participants also completed interviews assessing their experience in the study and barriers to participation. These test participants informed modifications to the protocol for the remaining participants. Results: The project received funding in April of 2023. Enrollment began in March of 2023 and is planned to be completed in April 2025. Among the 6 test participants, the overall EMA response rate was 87% (range 74%-95%). The response rate for the EMA survey including daily items (67%, range 21%-93%) was lower than the earlier shorter EMA surveys (89%, range 81%-96%). The mean rate of valid accelerometer wear of at least 20 hours per day was 93% (SD 11%), and continuous glucose monitoring data were available for 91% (SD 17%) of days on average. Participants reported few barriers to completing EMA surveys but noted the random timing of questions made it difficult to plan around, and the end-of-day survey was long. Two participants reported survey items reminded or motivated them to engage in diabetes self-management behaviors. Conclusions: Assessment tools developed from this study can inform clinical decision-making by considering barriers to self-management that occur in daily life. Clinical applications include tailored, adaptive technology–supported interventions to improve self-management that provide the right type and amount of support at the right time by adapting to an individual’s changing internal and contextual state. International Registered Report Identifier (IRRID): DERR1-10.2196/53874 %M 37983070 %R 10.2196/53874 %U https://www.researchprotocols.org/2023/1/e53874 %U https://doi.org/10.2196/53874 %U http://www.ncbi.nlm.nih.gov/pubmed/37983070 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e51334 %T mHealth Intervention to Promote Physical Activity Among Employees Using a Deep Learning Model for Passive Monitoring of Depression and Anxiety: Single-Arm Feasibility Trial %A Watanabe,Kazuhiro %A Okusa,Shoichi %A Sato,Mitsuhiro %A Miura,Hideki %A Morimoto,Masahiro %A Tsutsumi,Akizumi %+ Department of Public Health, Kitasato University School of Medicine, 1-15-1 Kitazato, Minami-ku, Sagamihara, 252-0374, Japan, 81 427789352, kzwatanabe-tky@umin.ac.jp %K eHealth %K behavioral change %K mobile phone %K smartphone %K mHealth %K mobile health %K app %K apps %K applications %K monitor %K monitoring %K physical activity %K exercise %K fitness %K application %K workplace %K distress %K depression %K depressive %K anxiety %K mental health %K worker %K workers %K employee %K employees %K occupational health %K satisfaction %K feasibility %K acceptability %D 2023 %7 17.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Physical activity effectively prevents depression and anxiety. Although mobile health (mHealth) technologies offer promising results in promoting physical activity and improving mental health, conflicting evidence exists on their effectiveness, and employees face barriers to using mHealth services. To address these problems, we recently developed a smartphone app named ASHARE to prevent depression and anxiety in the working population; it uses a deep learning model for passive monitoring of depression and anxiety from information about physical activity. Objective: This study aimed to preliminarily investigate (1) the effectiveness of the developed app in improving physical activity and reducing depression and anxiety and (2) the app’s implementation outcomes (ie, its acceptability, appropriateness, feasibility, satisfaction, and potential harm). Methods: We conducted a single-arm interventional study. From March to April 2023, employees aged ≥18 years who were not absent were recruited. The participants were asked to install and use the app for 1 month. The ideal usage of the app was for the participants to take about 5 minutes every day to open the app, check the physical activity patterns and results of an estimated score of psychological distress, and increase their physical activity. Self-reported physical activity (using the Global Physical Activity Questionnaire, version 2) and psychological distress (using the 6-item Kessler Psychological Distress Scale) were measured at baseline and after 1 month. The duration of physical activity was also recorded digitally. Paired t tests (two-tailed) and chi-square tests were performed to evaluate changes in these variables. Implementation Outcome Scales for Digital Mental Health were also measured for acceptability, appropriateness, feasibility, satisfaction, and harm. These average scores were assessed by comparing them with those reported in previous studies. Results: This study included 24 employees. On average, the app was used for 12.54 days (44.8% of this study’s period). After using the app, no significant change was observed in physical activity (–12.59 metabolic equivalent hours per week, P=.31) or psychological distress (–0.43 metabolic equivalent hours per week, P=.93). However, the number of participants with severe psychological distress decreased significantly (P=.01). The digitally recorded duration of physical activity increased during the intervention period (+0.60 minutes per day, P=.08). The scores for acceptability, appropriateness, and satisfaction were lower than those in previous mHealth studies, whereas those for feasibility and harm were better. Conclusions: The ASHARE app was insufficient in promoting physical activity or improving psychological distress. At this stage, the app has many issues that are to be addressed in terms of both implementation and effectiveness. The main reason for this low effectiveness might be the poor evaluation of the implementation outcomes by app users. Improving acceptability, appropriateness, and satisfaction are identified as key issues to be addressed in future implementation. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000050430; https://tinyurl.com/mrx5ntcmrecptno=R000057438 %M 37976094 %R 10.2196/51334 %U https://formative.jmir.org/2023/1/e51334 %U https://doi.org/10.2196/51334 %U http://www.ncbi.nlm.nih.gov/pubmed/37976094 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48740 %T Assessing the Efficacy and Safety of a Digital Therapeutic for Symptoms of Depression in Adolescents: Protocol for a Randomized Controlled Trial %A Furman,Daniella J %A Hall,Shana A %A Avina,Claudia %A Kulikov,Vera N %A Lake,Jessica I %A Padmanabhan,Aarthi %+ Big Health, Inc, 461 Bush St #200, San Francisco, CA, 94108, United States, 1 707 563 1049, daniella.furman@bighealth.com %K randomized controlled trial %K depression %K adolescent %K youth %K mental health %K digital therapeutic %K behavioral activation %K cognitive behavioral therapy %K virtual trial %K efficacy %K treatment %K digital health %K intervention %K mental illness %D 2023 %7 16.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Depression is a serious, prevalent, recurrent, and undertreated disorder in adolescents. Low levels of treatment seeking and treatment adherence in this age group, combined with a growing national crisis in access to mental health care, have increased efforts to identify effective treatment alternatives for this demographic. Digital health interventions for mental illness can provide cost-effective, engaging, and accessible means of delivering psychotherapy to adolescents. Objective: This protocol describes a virtual randomized controlled trial designed to evaluate the efficacy and safety of a self-guided, mobile app–based implementation of behavioral activation therapy, SparkRx, for the adjunct treatment of symptoms of depression in adolescents. Methods: Participants are recruited directly through web-based and print advertisements. Following eligibility screening and consenting, participants are randomly assigned to a treatment arm (SparkRx) or a control arm (assessment-enhanced usual care) for 5 weeks. The primary efficacy outcome, total score on the 8-item Patient Health Questionnaire (PHQ-8), is assessed at the end of the 5-week intervention period. Additional participant-reported outcomes are assessed at baseline, the postintervention time point, and 1-month follow-up. The safety of the intervention is assessed by participant report (and legal guardian report, if the participant is younger than 18 years) and by patterns of symptom deterioration on the PHQ-8, as part of a larger clinical safety monitoring protocol. The primary efficacy outcome, total PHQ-8 score at the postintervention time point, will be compared between SparkRx and enhanced usual care arms using mixed effect modeling, with baseline PHQ-8 and current antidepressant medication status included as covariates. Secondary efficacy outcomes, including the proportion of participants exhibiting treatment response, remission, and minimal clinically significant improvement (all derived from total PHQ-8 scores), will be compared between groups using chi-square tests. Symptom severity at 1-month follow-up will also be compared between arms. Planned subgroup analyses will examine the robustness of treatment effects to differences in baseline symptom severity (PHQ-8 score <15 or ≥ 15) and age (younger than 18 years and older than 18 years). The primary safety outcome, the number of psychiatric serious adverse events, will be compared between trial arms using the Fisher exact test. All other adverse events will be presented descriptively. Results: As of May 2023, enrollment into the study has concluded; 223 participants were randomized. The analysis of the efficacy and safety data is expected to be completed by Fall 2023. Conclusions: We hypothesize that the results of this trial will support the efficacy and safety of SparkRx in attenuating symptoms of depression in adolescents. Positive results would more broadly support the prospect of using accessible, scientifically validated, digital therapeutics in the adjunct treatment of mental health disorders in this age range. Trial Registration: ClinicalTrials.gov NCT05462652; https://clinicaltrials.gov/study/NCT05462652 International Registered Report Identifier (IRRID): DERR1-10.2196/48740 %M 37971800 %R 10.2196/48740 %U https://www.researchprotocols.org/2023/1/e48740 %U https://doi.org/10.2196/48740 %U http://www.ncbi.nlm.nih.gov/pubmed/37971800 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e48950 %T Think Aloud Testing of a Smartphone App for Lifestyle Change Among Persons at Risk of Type 2 Diabetes: Usability Study %A Lunde,Pernille %A Skoglund,Gyri %A Olsen,Cecilie Fromholt %A Hilde,Gunvor %A Bong,Way Kiat %A Nilsson,Birgitta Blakstad %+ Department of Rehabilitation Science and Health Technology, Faculty of Health Sciences, Oslo Metropolitan University, P44, PB 4, Street Olavs Plass, Oslo, 0130, Norway, 47 48063537, plunde@oslomet.no %K mHealth %K mobile phone app %K smartphone %K lifestyle %K usability %K diabetes %K diabetic %K mobile health %K smartphone %K app %K apps %K application %K applications %K think-aloud %K think aloud %K user experience %K mobile phone %D 2023 %7 15.11.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Type 2 diabetes mellitus (DM2) is a leading cause of morbidity and mortality worldwide and is considered a global epidemic. Despite the growing evidence on the effectiveness of mobile health interventions in the management of DM2, the evidence on the effect of mobile health interventions in prevention of DM2 is sparse. Therefore, we have developed an app aiming to promote initiation of behavioral change and adherence to healthy behavior. Before commencing a small-scale randomized controlled trial to assess the feasibility of using an app for initiation and adherence of healthy behavior in people at risk of DM2, testing the usability of the app in the target population is warranted. Objective: The aim of this study was to assess the usability of an app among people at risk of DM2. Methods: A qualitative study with the use of a think aloud (TA) procedure was conducted from April to November 2022. The TA procedure consisted of 10 problem-solving tasks and a semistructured interview which was carried out after the tasks. These interviews served to gain more in-depth knowledge of the users experience of the problem-solving tasks. The TA-sessions and the postactivity interviews were recorded and transcribed verbatim, and the data were coded and analyzed following the principles of thematic analysis. Results: In total, 7 people at risk of DM2 with a median age of 66 (range 41-75) years participated in this study. The analysis resulted in the following themes: (1) user interface design; and (2) suggestions for improvements of the functionality of the app. Conclusions: Overall, the participants were satisfied with the usability of the app. Through the TA-sessions, real time perspective on the appeal, relevance, and utility of the app were gained. Only minor changes to the functionality of the prototype app were reported as necessary to improve the usability of the app. Points of guidance from the participants in this study have been adopted and incorporated into the final design of the app now being assessed for feasibility in a small-scale randomized controlled trial. %M 37966894 %R 10.2196/48950 %U https://humanfactors.jmir.org/2023/1/e48950 %U https://doi.org/10.2196/48950 %U http://www.ncbi.nlm.nih.gov/pubmed/37966894 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47404 %T Testing a Digital Health App for Patients With Alcohol-Associated Liver Disease: Mixed Methods Usability Study %A Park,Linda S %A Kornfield,Rachel %A Yezihalem,Mihret %A Quanbeck,Andrew %A Mellinger,Jessica %A German,Margarita %+ Department of Family Medicine and Community Health, School of Medicine and Public Health, University of Wisconsin-Madison, 610 N. Whitney Way #200, Madison, WI, 53705, United States, 1 608 345 6859, linda.park@fammed.wisc.edu %K alcohol-associated liver disease %K ALD %K alcohol use disorder %K AUD %K mobile health %K mHealth %K digital tools %K alcohol cessation %K usability test %K mobile phone %D 2023 %7 15.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Alcohol-associated liver disease (ALD) is increasingly common and associated with serious and costly health consequences. Cessation of drinking can improve ALD morbidity and mortality; however, support for cessation is not routinely offered to those diagnosed with ALD, and continued drinking or resumption of drinking after diagnosis is common. Mobile health (mHealth) has the potential to offer convenient and scalable support for alcohol cessation to those diagnosed with ALD, but mHealth interventions for alcohol cessation have not been designed for or evaluated in a population with ALD. Objective: This study aims to understand how individuals with ALD would perceive and use an mHealth tool for alcohol cessation and to gather their perspectives on potential refinements to the tool that would allow it to better meet their needs. Methods: We interviewed 11 individuals who attended clinic visits related to their ALD to elicit their needs related to support for alcohol cessation and views on how mHealth could be applied. After completing initial interviews (pre), participants were provided with access to an mHealth app designed for alcohol cessation, which they used for 1 month. Afterward, they were interviewed again (post) to give feedback on their experiences, including aspects of the app that met their needs and potential refinements. We applied a mixed methods approach, including a qualitative analysis to identify major themes from the interview transcripts and descriptive analyses of use of the app over 1 month. Results: First, we found that a diagnosis of ALD is perceived as a motivator to quit drinking but that patients had difficulty processing the overwhelming amount of information about ALD they received and finding resources for cessation of alcohol use. Second, we found that the app was perceived as usable and useful for supporting drinking recovery, with patients responding favorably to the self-tracking and motivational components of the app. Finally, patients identified areas in which the app could be adapted to meet the needs of patients with ALD, such as providing information on the medical implications of an ALD diagnosis and how to care for their liver as well as connecting individuals with ALD to one another via a peer-to-peer support forum. Rates of app use were high and sustained across the entire study, with participants using the app a little more than half the days during the study on average and with 100% (11/11) of participants logging in each week. Conclusions: Our results highlight the need for convenient access to resources for alcohol cessation after ALD diagnosis and support the potential of an mHealth approach to integrate recovery support into care for ALD. Our findings also highlight the ways the alcohol cessation app should be modified to address ALD-specific concerns. %M 37966869 %R 10.2196/47404 %U https://formative.jmir.org/2023/1/e47404 %U https://doi.org/10.2196/47404 %U http://www.ncbi.nlm.nih.gov/pubmed/37966869 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e50870 %T A Mobile Intervention Designed Specifically for Older Adults With Frailty to Support Healthy Eating: Pilot Randomized Controlled Trial %A Su,Yan %A Wu,Kuan-Ching %A Chien,Shao-Yun %A Naik,Aishwarya %A Zaslavsky,Oleg %+ School of Nursing, University of Washington, 1959 NE Pacific Ave, Box 357266, Seattle, WA, 98195-7266, United States, 1 206 849 3301, ozasl@uw.edu %K frailty %K healthy eating %K mobile %K mHealth %K mobile health %K app %K apps %K clinical trial %K Mediterranean diet %K metabolic health %K diet %K dietary %K RCT %K randomized controlled trial %K randomized %K controlled trial %K controlled trials %K frail %K eating %K food %K nutrition %K adherence %D 2023 %7 15.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Frailty, a common geriatric syndrome, predisposes older adults to functional decline. No medications can alter frailty's trajectory, but nutritional interventions may aid in supporting independence. Objective: This paper presents a pilot randomized controlled trial to investigate the feasibility and efficacy of a mobile health intervention, “Olitor,” designed to enhance adherence to the Mediterranean diet among older adults with frailty, requiring no external assistance. Methods: The study sample consisted of 15 participants aged 66-77 (mean 70.5, SD 3.96) years randomized into intervention (n=8; 8 females; mean 72.4, SD 4.8 years) and control groups (n=7; 6 females, 1 male; mean 70.0, SD 3.9 years). The intervention involved a patient-facing mobile app called “Olitor” and a secure web-based administrative dashboard. Participants were instructed to use the app at least weekly for 3 months, which provided feedback on their food choices, personalized recipe recommendations, and an in-app messaging feature. Using Mann-Whitney tests to compare change scores and Hedges g statistics to estimate effect sizes, the primary efficacy outcomes were adherence to the Mediterranean diet score and insulin resistance measures. Secondary outcomes included retention as a measure of feasibility, engagement level and user app quality ratings for acceptability, and additional metrics to evaluate efficacy. Models were adjusted for multiple comparisons. Results: The findings demonstrated a significant improvement in the Mediterranean diet adherence score in the intervention group compared to the control (W=50.5; adjusted P=.04) with median change scores of 2 (IQR 2-4.25) and 0 (IQR –0.50 to 0.50), respectively. There was a small and insignificant reduction in homeostasis model assessment of insulin resistance measure (W=23; adjusted P=.85). Additionally, there were significant increases in legume intake (W=54; adjusted P<.01). The intervention's effect size was large for several outcomes, such as Mediterranean diet adherence (Hedges g=1.58; 95% CI 0.34-2.67) and vegetable intake (Hedges g=1.14; 95% CI 0.08-2.21). The retention rate was 100%. The app's overall quality rating was favorable with an average interaction time of 12 minutes weekly. Conclusions: This pilot study revealed the potential of the mobile intervention “Olitor” in promoting healthier eating habits among older adults with frailty. It demonstrated high retention rates, significant improvement in adherence to the Mediterranean diet, and increased intake of recommended foods. Insulin resistance showed a minor nonsignificant improvement. Several secondary outcomes, such as lower extremity function and Mediterranean diet knowledge, had a large effect size. Although the app's behavior change features were similar to those of previous digital interventions, the distinctive focus on theory-informed mechanistic measures involved in behavioral change, such as self-regulation, self-efficacy, and expected negative outcomes, may have enhanced its potential. Further investigations in a more diverse and representative population, focusing on individuals with impaired insulin sensitivity, are warranted to validate these preliminary findings. Trial Registration: ClinicalTrials.gov NCT05236712; https://clinicaltrials.gov/study/NCT05236712 %M 37966877 %R 10.2196/50870 %U https://formative.jmir.org/2023/1/e50870 %U https://doi.org/10.2196/50870 %U http://www.ncbi.nlm.nih.gov/pubmed/37966877 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e48634 %T The Effects of Remote Cognitive Training Combined With a Mobile App Intervention on Psychosis: Double-Blind Randomized Controlled Trial %A Fisher,Melissa %A Etter,Kevin %A Murray,Aimee %A Ghiasi,Neelu %A LaCross,Kristin %A Ramsay,Ian %A Currie,Ariel %A Fitzpatrick,Karrie %A Biagianti,Bruno %A Schlosser,Danielle %A Loewy,Rachel %A Vinogradov,Sophia %+ Department of Psychiatry & Behavioral Sciences, University of Minnesota, F299/2A West, 2450 Riverside Avenue, Minneapolis, MN, 55454, United States, 1 612 273 9835, mafisher@umn.edu %K schizophrenia %K psychosis %K cognitive training %K motivation %K mobile intervention %K mobile phone %D 2023 %7 13.11.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Impairments in cognition and motivation are core features of psychosis and strong predictors of social and occupational functioning. Accumulating evidence indicates that cognitive deficits in psychosis can be improved by computer-based cognitive training programs; however, barriers include access and adherence to cognitive training exercises. Limited evidence-based methods have been established to enhance motivated behavior. In this study, we tested the effects of web-based targeted cognitive and social cognitive training (TCT) delivered in conjunction with an innovative digital smartphone app called Personalized Real-Time Intervention for Motivational Enhancement (PRIME). The PRIME app provides users with a motivational coach to set personalized goals and secure social networking for peer support. Objective: This study investigated whether deficits in cognition and motivation in people with a psychosis spectrum disorder (N=100) can be successfully addressed with 30 hours of TCT+PRIME as compared with 30 hours of a computer games control condition (CG) plus PRIME (CG+PRIME). Here, we describe our study procedures, the feasibility and acceptability of the intervention, and the results on all primary outcomes. Methods: In this double-blind randomized controlled trial, English-speaking participants completed all cognitive training, PRIME activities, and assessments remotely. Participants completed a diagnostic interview and remote cognitive, clinical, and self-report measures at baseline, posttraining, and at a 6-month follow-up. Results: This study included participants from 27 states across the United States and 8 countries worldwide. The study population was 58% (58/100) female, with a mean age of 33.77 (SD 10.70) years. On average, participants completed more than half of the cognitive training regimen (mean 18.58, SD 12.47 hours of training), and logged into the PRIME app 4.71 (SD 1.58) times per week. The attrition rate of 22% (22/100) was lower than that reported in our previous studies on remote cognitive training. The total sample showed significant gains in global cognition (P=.03) and attention (P<.001). The TCT+PRIME participants showed significantly greater gains in emotion recognition (P<.001) and global cognition at the trend level (P=.09), although this was not statistically significant, relative to the CG+PRIME participants. The total sample also showed significant improvements on multiple indices of motivation (P=.02-0.05), in depression (P=.04), in positive symptoms (P=.04), and in negative symptoms at a trend level (P=.09), although this was not statistically significant. Satisfaction with the PRIME app was rated at 7.74 (SD 2.05) on a scale of 1 to 10, with higher values indicating more satisfaction. Conclusions: These results demonstrate the feasibility and acceptability of remote cognitive training combined with the PRIME app and that this intervention can improve cognition, motivation, and symptoms in individuals with psychosis. TCT+PRIME appeared more effective in improving emotion recognition and global cognition than CG+PRIME. Future analyses will test the relationship between hours of cognitive training completed; PRIME use; and changes in cognition, motivation, symptoms, and functioning. Trial Registration: ClinicalTrials.gov NCT02782442; https://clinicaltrials.gov/study/NCT02782442 %M 37955951 %R 10.2196/48634 %U https://www.jmir.org/2023/1/e48634 %U https://doi.org/10.2196/48634 %U http://www.ncbi.nlm.nih.gov/pubmed/37955951 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e48853 %T App-Supported Lifestyle Interventions in Pregnancy to Manage Gestational Weight Gain and Prevent Gestational Diabetes: Scoping Review %A Raab,Roxana %A Geyer,Kristina %A Zagar,Sophia %A Hauner,Hans %+ Institute of Nutritional Medicine, Else Kröner Fresenius Centre for Nutritional Medicine, TUM School of Medicine and Health, Technical University of Munich, Georg-Brauchle-Ring 62, Munich, 80992, Germany, 49 892 892 4921, hans.hauner@tum.de %K mobile health %K mHealth %K eHealth %K mobile app %K lifestyle intervention %K pregnancy %K gestational weight gain %K gestational diabetes %K prevention %K overweight %K obesity %K mobile phone %D 2023 %7 10.11.2023 %9 Review %J J Med Internet Res %G English %X Background: Excessive gestational weight gain (GWG) and gestational diabetes mellitus (GDM) are common pregnancy complications that have been shown to be preventable through the use of lifestyle interventions. However, a significant gap exists between research on pregnancy lifestyle interventions and translation into clinical practice. App-supported interventions might aid in overcoming previous implementation barriers. The current status in this emerging research area is unknown. Objective: This scoping review aims to provide a comprehensive overview of planned, ongoing, and completed studies on eHealth and mobile health (mHealth) app–supported lifestyle interventions in pregnancy to manage GWG and prevent GDM. The review assesses the scope of the literature in the field; describes the population, intervention, control, outcomes, and study design (PICOS) characteristics of included studies as well as the findings on GWG and GDM outcomes; and examines app functionalities. Methods: The scoping review was conducted according to a preregistered protocol and followed established frameworks. Four electronic databases and 2 clinical trial registers were systematically searched. All randomized and quasi-randomized controlled trials (RCTs) of app-supported lifestyle interventions in pregnancy and related qualitative and quantitative research across the different study phases were considered for inclusion. Eligible studies and reports of studies were included until June 2022. Extracted data were compiled in descriptive analyses and reported in narrative, tabular, and graphical formats. Results: This review included 97 reports from 43 lifestyle intervention studies. The number of published reports has steadily increased in recent years; of the 97 included reports, 38 (39%) were trial register entries. Of the 39 identified RCTs, 10 efficacy or effectiveness trials and 8 pilot trials had published results on GWG (18/39, 46%); of these 18 trials, 7 (39%) trials observed significant intervention effects on GWG outcomes. Of all 39 RCTs, 5 (13%) efficacy or effectiveness trials reported GDM results, but none observed significant intervention effects on GDM. The RCTs included in the review were heterogeneous in terms of their PICOS characteristics. Most of the RCTs were conducted in high-income countries, included women with overweight or obesity and from all BMI categories, delivered multicomponent interventions, delivered interventions during pregnancy only, and focused on diet and physical activity. The apps used in the studies were mostly mHealth apps that included features for self-monitoring, feedback, goal setting, prompts, and educational content. Self-monitoring was often supported by wearable activity monitors and Bluetooth-connected weight scales. Conclusions: Research in this field is nascent, and the effectiveness and implementability of app-supported interventions have yet to be determined. The complexity and heterogeneity of intervention approaches pose challenges in identifying the most beneficial app features and intervention components and call for consistent and comprehensive intervention and outcome reporting. %M 37948111 %R 10.2196/48853 %U https://www.jmir.org/2023/1/e48853 %U https://doi.org/10.2196/48853 %U http://www.ncbi.nlm.nih.gov/pubmed/37948111 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e47475 %T Digital Tool-Assisted Hospitalization Detection in the Tailored Antiplatelet Initiation to Lessen Outcomes due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention Study Compared to Traditional Site-Coordinator Ascertainment: Intervention Study %A Avram,Robert %A Byrne,Julia %A So,Derek %A Iturriaga,Erin %A Lennon,Ryan %A Murthy,Vishakantha %A Geller,Nancy %A Goodman,Shaun %A Rihal,Charanjit %A Rosenberg,Yves %A Bailey,Kent %A Farkouh,Michael %A Bell,Malcolm %A Cagin,Charles %A Chavez,Ivan %A El-Hajjar,Mohammad %A Ginete,Wilson %A Lerman,Amir %A Levisay,Justin %A Marzo,Kevin %A Nazif,Tamim %A Tanguay,Jean-Francois %A Pletcher,Mark %A Marcus,Gregory M %A Pereira,Naveen L %A Olgin,Jeffrey %+ Department of Cardiovascular Medicine, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, United States, 1 5072844441, pereira.naveen@mayo.edu %K web-based digital study %K randomized clinical trial %K study app %K clinical tracking cardiovascular hospitalizations %K detection %K digital tools %K tool %K clinical trial %K research application %K application %K smartphone application %K mobile phone survey %K survey %K hospital %K accuracy %K geofencing %K cardiovascular %K algorithm %K hospital visit %K mobile phone %D 2023 %7 10.11.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Accurate, timely ascertainment of clinical end points, particularly hospitalizations, is crucial for clinical trials. The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI) Digital Study extended the main TAILOR-PCI trial's follow-up to 2 years, using a smartphone-based research app featuring geofencing-triggered surveys and routine monthly mobile phone surveys to detect cardiovascular (CV) hospitalizations. This pilot study compared these digital tools to conventional site-coordinator ascertainment of CV hospitalizations. Objective: The objectives were to evaluate geofencing-triggered notifications and routine monthly mobile phone surveys' performance in detecting CV hospitalizations compared to telephone visits and health record reviews by study coordinators at each site. Methods: US and Canadian participants from the TAILOR-PCI Digital Follow-Up Study were invited to download the Eureka Research Platform mobile app, opting in for location tracking using geofencing, triggering a smartphone-based survey if near a hospital for ≥4 hours. Participants were sent monthly notifications for CV hospitalization surveys. Results: From 85 participants who consented to the Digital Study, downloaded the mobile app, and had not previously completed their final follow-up visit, 73 (85.8%) initially opted in and consented to geofencing. There were 9 CV hospitalizations ascertained by study coordinators among 5 patients, whereas 8 out of 9 (88.9%) were detected by routine monthly hospitalization surveys. One CV hospitalization went undetected by the survey as it occurred within two weeks of the previous event, and the survey only allowed reporting of a single hospitalization. Among these, 3 were also detected by the geofencing algorithm, but 6 out of 9 (66.7%) were missed by geofencing: 1 occurred in a participant who never consented to geofencing, while 5 hospitalizations occurred among participants who had subsequently turned off geofencing prior to their hospitalization. Geofencing-detected hospitalizations were ascertained within a median of 2 (IQR 1-3) days, monthly surveys within 11 (IQR 6.5-25) days, and site coordinator methods within 38 (IQR 9-105) days. The geofencing algorithm triggered 245 notifications among 39 participants, with 128 (52.2%) from true hospital presence and 117 (47.8%) from nonhospital health care facility visits. Additional geofencing iterative improvements to reduce hospital misidentification were made to the algorithm at months 7 and 12, elevating the rate of true alerts from 35.4% (55 true alerts/155 total alerts before month 7) to 78.7% (59 true alerts/75 total alerts in months 7-12) and ultimately to 93.3% (14 true alerts/5 total alerts in months 13-21), respectively. Conclusions: The monthly digital survey detected most CV hospitalizations, while the geofencing survey enabled earlier detection but did not offer incremental value beyond traditional tools. Digital tools could potentially reduce the burden on study coordinators in ascertaining CV hospitalizations. The advantages of timely reporting via geofencing should be weighed against the issue of false notifications, which can be mitigated through algorithmic refinements. %M 37948098 %R 10.2196/47475 %U https://www.jmir.org/2023/1/e47475 %U https://doi.org/10.2196/47475 %U http://www.ncbi.nlm.nih.gov/pubmed/37948098 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e48896 %T Use of e-Cigarettes in Cigarette Smoking Cessation: Secondary Analysis of a Randomized Controlled Trial %A Santiago-Torres,Margarita %A Mull,Kristin E %A Sullivan,Brianna M %A Bricker,Jonathan B %+ Fred Hutchinson Cancer Center, 1100 Fairview Avenue North, Seattle, WA, 98109, United States, 1 2066674780, msantiag@fredhutch.org %K acceptance and commitment therapy %K cigarette smoking %K digital behavioral interventions %K e-cigarettes %K smoking cessation %K smartphone apps %K vaping %K mobile phone %D 2023 %7 9.11.2023 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Many adults use e-cigarettes to help them quit cigarette smoking. However, the impact of self-selected use of e-cigarettes on cigarette smoking cessation, particularly when concurrently receiving app-based behavioral interventions, remains unexplored. Objective: This study used data from a randomized trial of 2 smartphone apps to compare 12-month cigarette smoking cessation rates between participants who used e-cigarettes on their own (ie, adopters: n=465) versus those who did not (ie, nonadopters: n=1097). Methods: The study population included all participants who did not use e-cigarettes at baseline. “Adopters” were those who self-reported the use of e-cigarettes at either 3- or 6-month follow-ups. “Nonadopters” were those who self-reported no use of e-cigarettes at either follow-up time point. The primary cessation outcome was self-reported, complete-case, 30-day point prevalence abstinence from cigarette smoking at 12 months. Secondary outcomes were missing-as-smoking and multiple imputation analyses of the primary outcome, prolonged abstinence, and cessation of all nicotine and tobacco products at 12 months. In logistic regression models, we first examined the potential interaction between e-cigarette use and treatment arm (iCanQuit vs QuitGuide) on the primary cessation outcome. Subsequently, we compared 12-month cigarette smoking cessation rates between adopters and nonadopters separately for each app. Results: There was suggestive evidence for an interaction between e-cigarette use and treatment arm on cessation (P=.05). In the iCanQuit arm, 12-month cigarette smoking cessation rates were significantly lower among e-cigarette adopters compared with nonadopters (41/193, 21.2% vs 184/527, 34.9%; P=.003; odds ratio 0.55, 95% CI 0.37-0.81). In contrast, in the QuitGuide arm, 12-month cigarette smoking cessation rates did not differ between adopters and nonadopters (46/246, 18.7% vs 104/522, 19.9%; P=.64; odds ratio 0.91, 95% CI 0.62-1.35). Conclusions: The use of e-cigarettes while concurrently receiving an app-based smoking cessation intervention was associated with either a lower or an unimproved likelihood of quitting cigarette smoking compared to no use. Future behavioral treatments for cigarette smoking cessation should consider including information on the potential consequences of e-cigarette use. Trial Registration: ClinicalTrials.gov NCT02724462; https://clinicaltrials.gov/study/NCT02724462 %M 37943594 %R 10.2196/48896 %U https://mhealth.jmir.org/2023/1/e48896 %U https://doi.org/10.2196/48896 %U http://www.ncbi.nlm.nih.gov/pubmed/37943594 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e50643 %T Designing Implementation Strategies for a Digital Suicide Safety Planning Intervention in a Psychiatric Emergency Department: Protocol for a Multimethod Research Project %A Shin,Hwayeon Danielle %A Zaheer,Juveria %A Torous,John %A Strudwick,Gillian %+ Institute of Health Policy, Management, and Evaluation, University of Toronto, 155 College St 4th Floor, Toronto, ON, M5T 3M6, Canada, 1 9022922836, hdanielle.shin@mail.utoronto.ca %K implementation science %K suicide prevention %K eHealth %K mental health %K health informatics %K integrated knowledge translation %K co-design %K research protocol %K mobile phone %D 2023 %7 9.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Suicide prevention is currently a national health priority in Canada. Emergency departments (EDs) are critical settings for suicide prevention, and in our local psychiatric ED at the Centre for Addiction and Mental Health, we plan to embed an app-based tool called the Hope app to support suicide safety planning intervention. The app is free and available on app stores, and usability tests have been completed. As a next step to embed this new tool into the routine clinical workflow, research is needed to assess determinants of and design strategies for implementation with the end goal of routinization. Objective: The purpose of this 2-phased research is to implement the app in the routine clinical workflow in our local psychiatric ED. The specific objectives are as follows: (1) understanding ED clinicians’ perceptions and experience of implementing the app in routine practice and identifying barriers to and facilitators of implementation (phase 1) and (2) using findings and outputs from phase 1 and collaborating with service users, families, and ED clinicians to co-design implementation strategies for the app (phase 2). Methods: We will use an integrated knowledge translation approach throughout this project. In phase 1, we will conduct interviews with ED clinicians to identify implementation determinants using a behavior change framework. In phase 2, a co-design team comprising clinicians, ED service users, and families will design implementation strategies that align with the determinants identified in phase 1. Results: This protocol presents detailed information about the entire structure of the 2-phased research project. Ethics approval for conducting the qualitative descriptive study (phase 1) has been obtained, and the recruitment and data collection processes will be completed no later than December 2023. Ethics approval for phase 2 is underway. Conclusions: Involving multiple knowledge user groups early in the research and decision-making process is crucial for successful implementation. Although co-designing is commonly practiced during innovation development, there is often a misconception that the responsibility for implementing what has been designed falls on others. This research aims to fill this methodological gap in the health informatics literature. By the end of this project, we will have developed theory-informed implementation strategies to support Centre for Addiction and Mental Health ED clinicians in adopting the Hope app to complete safety planning intervention. These strategies, guided by a behavior change framework, will target clinicians’ behavior change and seamlessly integrate the app into the routine clinical workflow. In addition, this research project will provide recommendations on how to involve multiple knowledge user groups and offer insights into how the methodology used can be adapted to other areas within the health informatics literature. International Registered Report Identifier (IRRID): PRR1-10.2196/50643 %M 37943582 %R 10.2196/50643 %U https://www.researchprotocols.org/2023/1/e50643 %U https://doi.org/10.2196/50643 %U http://www.ncbi.nlm.nih.gov/pubmed/37943582 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48761 %T Use of Immersive Virtual Reality Spaces to Engage Adolescent and Young Adult Patients With Cancer in Therapist-Guided Support Groups: Protocol for a Pre-Post Study %A Marks,Asher %A Garbatini,Amanda %A Hieftje,Kimberly %A Puthenpura,Vidya %A Weser,Veronica %A Fernandes,Claudia-Santi F %+ Section of Pediatric Hematology/Oncology, Department of Pediatrics, Yale School of Medicine, 333 York St., New Haven, CT, 06510, United States, 1 203 785 4640, asher.marks@yale.edu %K cancer %K virtual reality %K support groups %K peer support %K adolescent %K young adult %K resilience %K adolescents and young adults %K oncology %K therapist-guided support %K social isolation %K support system %K psychosocial support %K barrier %K quality of life %D 2023 %7 9.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: For adolescents and young adults, a cancer diagnoses can magnify feelings of social isolation at an inherently vulnerable developmental stage. Prior studies have highlighted the importance of peer groups during cancer treatment. Support groups help foster connection and resilience, but patients find in-person participation difficult due to a variety of factors. Additionally, physical changes brought on by cancer makes these patients hesitant to meet in person. The COVID-19 pandemic magnified these difficulties. Virtual reality (VR) allows for the creation of a therapist-curated, computer-generated social space that potentially enables support groups for this population. Objective: This protocol describes a pilot study examining the efficacy, feasibility, and acceptability of a social VR support group intervention for adolescent and young adult patients with cancer. Methods: We approached 20 participants aged 17-20 years, and 16 agreed to participate. Moreover, 1 participant dropped out due to hospitalization. Participants attended virtual, professionally facilitated support groups using Meta Quest VR headsets. The groups consisted of 4 participants and 1 facilitator, amounting to a total of 22 individual sessions. Each session lasted 45-60 minutes and took place weekly for 4-6 weeks. The primary aim of this study was to collect quantitative and qualitative data on the feasibility and acceptability of the intervention. Feasibility was measured through session participation rates and overall retention rates. The acceptability of the intervention was explored through brief in-person interviews with participants at the end of the final intervention session. The secondary aim of this study was to collect data on the preliminary efficacy of the intervention in decreasing symptoms of participant depression and anxiety and increasing positive affect and resiliency. Results: In total, 15 patients aged 17-20 years participated in 22 sessions between November 5, 2019, and July 8, 2021. The median age was 19 (IQR 17-20) years. Overall, 10 (62%) participants identified as male, 5 (31%) as female, and 1 (6%) as transgender female. Furthermore, 5 (31%) participants identified as Hispanic, 1 (6%) identified as non-Hispanic Asian, 3 (19%) identified as non-Hispanic Black, 6 (38%) identified as non-Hispanic White, and 1 (6%) identified as other race or ethnicity. Hematologic malignancies or bone marrow failure was the most common diagnosis (8/16, 50%). The mean attendance rate was 72.8% (SD 25.7%) and retention was 86.7% (SD 0.35%). Moreover, 45% (10/22) of sessions had to be postponed by a week or more due to unexpected participant scheduling issues. Conclusions: The use of VR to deliver psychosocial support for adolescents and young adults with cancer may reduce common barriers associated with attending in-person peer support groups while improving quality-of-life measures. The data from this study will inform future studies focused on conducting VR support groups in other rare disease populations, including older adults with cancer. International Registered Report Identifier (IRRID): DERR1-10.2196/48761 %M 37943596 %R 10.2196/48761 %U https://www.researchprotocols.org/2023/1/e48761 %U https://doi.org/10.2196/48761 %U http://www.ncbi.nlm.nih.gov/pubmed/37943596 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48485 %T Progressive Transition From Supervised to Unsupervised Robot-Assisted Therapy After Stroke: Protocol for a Single-Group, Interventional Feasibility Study %A Devittori,Giada %A Ranzani,Raffaele %A Dinacci,Daria %A Romiti,Davide %A Califfi,Antonella %A Petrillo,Claudio %A Rossi,Paolo %A Gassert,Roger %A Lambercy,Olivier %+ Rehabilitation Engineering Laboratory, Swiss Federal Institute of Technology Zürich, BAA Lengghalde 5, Zurich, 8008, Switzerland, 41 44 510 72 34, giada.devittori@hest.ethz.ch %K technology-assisted rehabilitation %K unsupervised therapy %K self-directed therapy %K stroke %K neurorehabilitation %K neurocognitive rehabilitation %K robot-assisted therapy %K rehabilitation technology %K robot. %D 2023 %7 9.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Increasing the dose of therapy delivered to patients with stroke may improve functional outcomes and quality of life. Unsupervised technology-assisted rehabilitation is a promising way to increase the dose of therapy without dramatically increasing the burden on the health care system. Despite the many existing technologies for unsupervised rehabilitation, active rehabilitation robots have rarely been tested in a fully unsupervised way. Furthermore, the outcomes of unsupervised technology-assisted therapy (eg, feasibility, acceptance, and increase in therapy dose) vary widely. This might be due to the use of different technologies as well as to the broad range of methods applied to teach the patients how to independently train with a technology. Objective: This paper describes the study design of a clinical study investigating the feasibility of unsupervised therapy with an active robot and of a systematic approach for the progressive transition from supervised to unsupervised use of a rehabilitation technology in a clinical setting. The effect of unsupervised therapy on achievable therapy dose, user experience in this therapy setting, and the usability of the rehabilitation technology are also evaluated. Methods: Participants of the clinical study are inpatients of a rehabilitation clinic with subacute stroke undergoing a 4-week intervention where they train with a hand rehabilitation robot. The first week of the intervention is supervised by a therapist, who teaches participants how to interact and train with the device. The second week consists of minimally supervised therapy, where the therapist is present but intervenes only if needed as participants exercise with the device. If the participants properly learn how to train with the device, they proceed to the unsupervised phase and train without any supervision during the third and fourth weeks. Throughout the duration of the study, data on feasibility and therapy dose (ie, duration and repetitions) are collected. Usability and user experience are evaluated at the end of the second (ie, minimally supervised) and fourth (ie, unsupervised) weeks, allowing us to investigate the effect of therapist absence. Results: As of April 2023, 13 patients were recruited and completed the protocol, with no reported adverse events. Conclusions: This study will inform on the feasibility of fully unsupervised rehabilitation with an active rehabilitation robot in a clinical setting and its effect on therapy dose. Furthermore, if successful, the proposed systematic approach for a progressive transition from supervised to unsupervised technology-assisted rehabilitation could serve as a benchmark to allow for easier comparisons between different technologies. This approach could also be extended to the application of such technologies in the home environment, as the supervised and minimally supervised sessions could be performed in the clinic, followed by unsupervised therapy at home after discharge. Trial Registration: ClinicalTrials.gov NCT04388891; https://clinicaltrials.gov/study/NCT04388891 International Registered Report Identifier (IRRID): DERR1-10.2196/48485 %M 37943580 %R 10.2196/48485 %U https://www.researchprotocols.org/2023/1/e48485 %U https://doi.org/10.2196/48485 %U http://www.ncbi.nlm.nih.gov/pubmed/37943580 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e41393 %T An After-Hours Virtual Care Service for Children With Medical Complexity and New Medical Technology: Mixed Methods Feasibility Study %A Babayan,Katherine %A Keilty,Krista %A Esufali,Jessica %A Grajales III,Francisco J %A , %+ Institute of Health Policy, Management and Evaluation, University of Toronto, 155 College Street, Toronto, ON, M5T 3M6, Canada, 1 (416) 978 4326, katherine.babayan@gmail.com %K children with medical complexity %K technology dependence %K medical devices %K family caregivers %K virtual care %K home and community care %K emergency department visits %K enteral feeding tubes %K hospital-to-home transition %K feasibility %K mixed methods %D 2023 %7 8.11.2023 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Family caregivers (FCs) of children with medical complexity require specialized support to promote the safe management of new medical technologies (eg, gastrostomy tubes) during hospital-to-home transitions. With limited after-hours services available to families in home and community care, medical device complications that arise often lead to increased FC stress and unplanned emergency department (ED) visits. To improve FC experiences, enable safer patient discharge, and reduce after-hours ED visits, this study explores the feasibility of piloting a 24/7 virtual care service (Connected Care Live) with families to provide real-time support by clinicians expert in the use of pediatric home care technologies. Objective: This study aims to establish the economic, operational, and technical feasibility of piloting the expansion of an existing nurse-led after-hours virtual care service offered to home and community care providers to FCs of children with newly inserted medical devices after hospital discharge at Toronto’s Hospital for Sick Children (SickKids). Methods: This exploratory study, conducted from October 2020 to August 2021, used mixed data sources to inform service expansion feasibility. Semistructured interviews were conducted with FCs, nurses, and hospital leadership to assess the risks, benefits, and technical and operational requirements for sustainable and cost-effective future service operations. Time and travel savings were estimated using ED visit data in SickKids’ electronic medical records (Epic) with a chief complaint of “medical device problems,” after-hours medical device inquiries from clinician emails and voicemails, and existing service operational data. Results: A total of 30 stakeholders were interviewed and voiced the need for the proposed service. Safer and more timely management of medical device complications, improved caregiver and provider experiences, and strengthened partnerships were identified as expected benefits, while service demand, nursing practice, and privacy and security were identified as potential risks. A total of 47 inquiries were recorded over 2 weeks from March 26, 2021, to April 8, 2021, with 51% (24/47) assessed as manageable via service expansion. This study forecasted annual time and travel savings of 558 hours for SickKids and 904 hours and 22,740 km for families. Minimal technical and operational requirements were needed to support service expansion by leveraging an existing platform and clinical staff. Of the 212 ED visits related to “medical device problems” over 6 months from September 1, 2020, to February 28, 2021, enteral feeding tubes accounted for nearly two-thirds (n=137, 64.6%), with 41.6% (57/137) assessed as virtually manageable. Conclusions: Our findings indicate that it is feasible to pilot the expansion of Connected Care Live to FCs of children with newly inserted enteral feeding tubes. This nurse-led virtual caregiver service is a promising tool to promote safe hospital-to-home transitions, improve FC experiences, and reduce after-hours ED visits. %M 37938869 %R 10.2196/41393 %U https://pediatrics.jmir.org/2023/1/e41393 %U https://doi.org/10.2196/41393 %U http://www.ncbi.nlm.nih.gov/pubmed/37938869 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e51023 %T Online-Mediated HIV Pre-exposure Prophylaxis Care and Reduced Monitoring Frequency for Men Who Have Sex With Men: Protocol for a Randomized Controlled Noninferiority Trial (EZI-PrEP Study) %A Groot Bruinderink,Marije L %A Boyd,Anders %A Coyer,Liza %A Boers,Sophie %A Blitz,Laura %A Brand,Jean-Marie %A Götz,Hannelore M %A Stip,Martijn %A Woudstra,Joey %A Yap,Kenneth %A Vermey,Koenraad %A Matser,Amy %A Feddes,Allard R %A Jongen,Vita W %A Prins,Maria %A Hoornenborg,Elske %A van Harreveld,Frenk %A Schim van der Loeff,Maarten F %A Davidovich,Udi %+ Department of Infectious Diseases, Public Health Service of Amsterdam, Nieuwe Achtergracht 100, Amsterdam, 1018 WT, Netherlands, 31 205559414, mgrootbruinderink@ggd.amsterdam.nl %K pre-exposure prophylaxis %K randomized controlled trial %K telemedicine %K HIV prevention %K MSM %K men who have sex with men %K Netherlands %K adherence %K acceptability %K usability %D 2023 %7 8.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Daily and event-driven HIV pre-exposure prophylaxis (PrEP) with oral tenofovir-emtricitabine is highly effective to prevent HIV in men who have sex with men (MSM). PrEP care generally consists of in-clinic monitoring every 3 months that includes PrEP dispensing, counseling, and screening for HIV and sexually transmitted infections (STIs). However, the optimal frequency for monitoring remains undetermined. Attending a clinic every 3 months for monitoring may be a barrier for PrEP. Online-mediated PrEP care and reduced frequency of monitoring may lower this barrier. Objective: The primary objective of this study is to establish the noninferiority of online PrEP care (vs in-clinic care) and monitoring every 6 months (vs every 3 months). The secondary objectives are to (1) examine differences between PrEP care modalities regarding incidences of STIs, HIV infection, and hepatitis C virus infection; retention in PrEP care; intracellular tenofovir-diphosphate concentration; and satisfaction, usability, and acceptability of PrEP care modalities; and (2) evaluate associations of these study outcomes with sociodemographic, behavioral, and psychological characteristics. Methods: This study is a 2×2 factorial, 4-arm, open-label, multi-center, randomized, controlled, noninferiority trial. The 4 arms are (1) in-clinic monitoring every 3 months, (2) in-clinic monitoring every 6 months, (3) online monitoring every 3 months, and (4) online monitoring every 6 months. The primary outcome is a condomless anal sex act with a casual partner not covered or insufficiently covered by PrEP (ie, “unprotected act”) as a proxy for HIV infection risk. Eligible individuals are MSM, and transgender and gender diverse people aged ≥18 years who are eligible for PrEP care at 1 of 4 participating sexual health centers in the Netherlands. The required sample size is 442 participants, and the planned observation time is 24 months. All study participants will receive access to a smartphone app, which contains a diary. Participants are requested to complete the diary on a daily basis during the first 18 months of participation. Participants will complete questionnaires at baseline and 6, 12, 18, and 24 months. Dried blood spots will be collected at 6 and 12 months for assessment of intracellular tenofovir-diphosphate concentration. Incidence rates of unprotected acts will be compared between the online and in-clinic arms, and between the 6-month and 3-month arms. Noninferiority will be concluded if the upper limit of the 2-sided 97.5% CI of the incidence rate ratio is <1.8. Results: The results of the main analysis are expected in 2024. Conclusions: This trial will demonstrate whether online PrEP care and monitoring every 6 months is noninferior to standard PrEP care in terms of PrEP adherence. If noninferiority is established, these modalities may lower barriers for initiating and continuing PrEP use and potentially reduce the systemic burden for PrEP providers. Trial Registration: ClinicalTrials.gov NCT05093036; https://tinyurl.com/28b8ndvj International Registered Report Identifier (IRRID): DERR1-10.2196/51023 %M 37938875 %R 10.2196/51023 %U https://www.researchprotocols.org/2023/1/e51023 %U https://doi.org/10.2196/51023 %U http://www.ncbi.nlm.nih.gov/pubmed/37938875 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46640 %T Improving Knowledge, Engagement, and Self-Efficacy in the Creation of Healthy Home Environments for Mothers Using a Facebook Intervention (Design for Wellness): Randomized Controlled Trial %A Aperman-Itzhak,Tal %A Prilleltensky,Isaac %A Rosen,Laura %+ Department of Health Promotion, School of Public Health, Faculty of Medicine, Tel Aviv University, PO Box 39040, Ramat Aviv, Tel Aviv, 6997801, Israel, 972 508342585, talap1@gmail.com %K environmental home design %K wellness %K Facebook intervention %K nudging %K healthy living %K social media %K Israel %D 2023 %7 7.11.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Designing the home environment can promote well-being. Social networks provide learning opportunities to improve health. Objective: This study aimed to develop and evaluate a Facebook intervention called Design for Wellness (DWELL). The program was created to improve knowledge, engagement, and self-efficacy in the creation of healthy home environments. Methods: A randomized controlled trial was conducted to assess the effects of the intervention program DWELL. Content was uploaded to the Facebook group and gave the participants practical solutions for how to design their home environment for wellness. The intervention addressed multiple components of health behaviors, such as healthy eating, physical activity, tobacco-free environment, hygiene, family conversations regarding wellness issues, and stress reduction. The main outcome was the participants’ overall score on the DWELL index, which we developed to assess the elements of our intervention: knowledge, awareness, engagement, and self-efficacy regarding home design for wellness. The intervention was conducted in Israel and lasted 6 weeks during the third wave of the COVID-19 pandemic. The primary analysis included a multivariable model to assess the DWELL score at the end of the study while controlling for baseline characteristics. The waitlist control group did not receive an intervention between the 2 administrations of the questionnaire. Results: In total, 643 participants began the program: 322 (50.1%) in the intervention group and 321 (49.9%) in the control group. Of the 643 participants, 476 (74%) completed the study. At the end of the study, there was a statistically significant benefit of the intervention as assessed using a one-way analysis of covariance: there was a mean difference of 8.631 (SD 1.408) points in the DWELL score in favor of the intervention group (intervention: mean 61.92, SD 14.30; control: mean 53.29, SD 16.374; P<.001). Qualitative feedback from participants in the intervention group strengthened the positive results as most of them found the group beneficial. The Facebook group was very active. Being more engaged in the group correlated with having a higher DWELL score, but this relationship was weak (r=0.37; P<.001). The mean significant difference of 26.281 (SD 19.24) points between the overall DWELL score and the overall engagement score indicated that participants who were not active in the group still followed the posts and benefited. We found no improvements in the secondary outcome regarding participants’ well-being. The COVID-19 lockdown may have prevented this. Conclusions: DWELL was found to be a beneficial intervention for improving perceptions of the design of home environments to foster wellness. Facebook was an effective platform to deliver this intervention. DWELL may become a prototype for other health promotion interventions. Trial Registration: ClinicalTrials.gov NCT03736525; https://clinicaltrials.gov/study/NCT03736525?term=DWELL&rank=1 %M 37934566 %R 10.2196/46640 %U https://www.jmir.org/2023/1/e46640 %U https://doi.org/10.2196/46640 %U http://www.ncbi.nlm.nih.gov/pubmed/37934566 %0 Journal Article %@ 2369-3762 %I JMIR Publications %V 9 %N %P e48804 %T Supporting Clinical Competencies in Men’s Mental Health Using the Men in Mind Practitioner Training Program: User Experience Study %A Seidler,Zac E %A Benakovic,Ruben %A Wilson,Michael J %A Fletcher,Justine %A Oliffe,John L %A Owen,Jesse %A Rice,Simon M %+ Orygen, 35 Poplar Rd, Parkville, Melbourne, 3052, Australia, 61 0432 438 254, zac.seidler@orygen.org.au %K e-learning %K mental health services %K psychotherapy %K men’s mental health %K masculinity %D 2023 %7 7.11.2023 %9 Original Paper %J JMIR Med Educ %G English %X Background: Engaging men in psychotherapy is essential in male suicide prevention efforts, yet to date, efforts to upskill mental health practitioners in delivering gender-sensitized therapy for men have been lacking. To address this, we developed Men in Mind, an e-learning training program designed to upskill mental health practitioners in engaging men in therapy. Objective: This study involves an in-depth analysis of the user experience of the Men in Mind intervention, assessed as part of a randomized controlled trial of the efficacy of the intervention. Methods: Following completion of the intervention, participants provided qualitative (n=392) and quantitative (n=395) user experience feedback, focused on successes and suggested improvements to the intervention and improvements to their confidence in delivering therapy with specific subpopulations of male clients. We also assessed practitioner learning goals (n=242) and explored the extent to which participants had achieved these goals at follow-up. Results: Participants valued the inclusion of video demonstrations of skills in action alongside the range of evidence-based content dedicated to improving their insight into the engagement of men in therapy. Suggested improvements most commonly reflected the desire for more or more diverse content, alongside the necessary adaptations to improve the learning and user experience. Participants also commonly reported improved confidence in assisting men with difficulty articulating their emotions in therapy and suicidal men. Conclusions: The evidence obtained from this study aids in plans to scale Men in Mind and informs the future development of practitioner training interventions in men’s mental health. International Registered Report Identifier (IRRID): RR2-10.1186/s40359-022-00875-9 %M 37934579 %R 10.2196/48804 %U https://mededu.jmir.org/2023/1/e48804 %U https://doi.org/10.2196/48804 %U http://www.ncbi.nlm.nih.gov/pubmed/37934579 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e42194 %T Effectiveness of Reducing Craving in Alcohol Use Disorder Using a Serious Game (SALIENCE): Randomized Controlled Trial %A Weber,Antonia %A Shevchenko,Yury %A Gerhardt,Sarah %A Hoffmann,Sabine %A Kiefer,Falk %A Vollstädt-Klein,Sabine %+ Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Square J5, Mannheim, 68159, Germany, 49 1792011684, sabine.vollstaedt-klein@zi-mannheim.de %K alcohol approach bias %K alcohol attentional bias %K alcohol use disorder %K alcohol %K attention %K cognitive bias modification therapy %K craving %K cue-exposure therapy %K decision-making training %K decision-making %K incentive salience %K serious games %K therapy %K training %D 2023 %7 7.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Alcohol use disorder (AUD) has become a major global health problem. Therapy for this condition is still a great challenge. Recently, it has become increasingly evident that computer-based training is a valuable addition to the treatment of addictive disorders. Objective: This study aims to evaluate the web-based serious game SALIENCE (Stop Alcohol in Everyday Life-New Choices and Evaluations) as an add-on therapy for AUD. It combines the cue-exposure therapy approach with elements of decision-making training, enhanced by interactive panoramic images. The effects of SALIENCE training on levels of craving, attention, and cognitive bias are investigated. Methods: In a randomized controlled trial, 62 participants with AUD undergoing 3 weeks of an extended alcohol detoxification program were randomly allocated to an intervention and a control group. A total of 49 individuals (mean age 44.04 y; 17/49, 35% female) completed all sessions and were included in the analysis. Only pretreatment data were available from the other 13 patients. Participants answered questionnaires related to alcohol consumption and craving and completed neuropsychological tasks at the beginning of the study and 2 weeks later to evaluate levels of attention and cognitive biases. During the 2-week period, 27 of the participants additionally performed the SALIENCE training for 30 minutes 3 times a week, for a total of 6 sessions. Results: We observed a significant decrease in craving in both groups: the control group (mean 15.59, SD 8.02 on the first examination day vs mean 13.18, SD 8.38 on the second examination day) and the intervention group (mean 15.19, SD 6.71 on the first examination day vs mean 13.30, SD 8.47 on the second examination day; F1,47=4.31; P=.04), whereas the interaction effect was not statistically significant (F1,47=0.06; P=.80). Results of the multiple linear regression controlling for individual differences between participants indicated a significantly greater decrease in craving (β=4.12; t36=2.34; P=.03) with the SALIENCE intervention. Participants with lower drinking in negative situations reduced their craving (β=.38; t36=3.01; P=.005) more than people with higher drinking in negative situations. Conclusions: The general effectiveness of SALIENCE training as an add-on therapy in reducing alcohol craving was not confirmed. Nevertheless, taking into account individual differences (gender, duration of dependence, stress, anxiety, and drinking behavior in different situations), it was shown that SALIENCE training resulted in a larger reduction in craving than without. Notably, individuals who rarely consume alcohol due to negative affect profited the most from SALIENCE training. In addition to the beneficial effect of SALIENCE training, these findings highlight the relevance of individualized therapy for AUD, adapted to personal circumstances such as drinking motivation. Trial Registration: ClinicalTrials.gov NCT03765476; https://clinicaltrials.gov/show/NCT03765476 %M 37934561 %R 10.2196/42194 %U https://formative.jmir.org/2023/1/e42194 %U https://doi.org/10.2196/42194 %U http://www.ncbi.nlm.nih.gov/pubmed/37934561 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e45068 %T Effects of a Self-Guided Transdiagnostic Smartphone App on Patient Empowerment and Mental Health: Randomized Controlled Trial %A Kerber,André %A Beintner,Ina %A Burchert,Sebastian %A Knaevelsrud,Christine %+ Department of Clinical-Psychological Intervention, Freie Universität Berlin, Habelschwerdter Allee 45, Berlin, 14195, Germany, 49 30 838 63093, andre.kerber@fu-berlin.de %K patient empowerment %K mental health–related self-management skills %K help-seeking attitude %K mental health literacy %K internet-based interventions %K unguided %K self-guided %K transdiagnostic mental health app %D 2023 %7 6.11.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Mental disorders impact both individuals and health systems. Symptoms and syndromes often remain undetected and untreated, resulting in chronification. Besides limited health care resources, within-person barriers such as the lack of trust in professionals, the fear of stigmatization, or the desire to cope with problems without professional help contribute to the treatment gap. Self-guided mental health apps may support treatment seeking by reducing within-person barriers and facilitating mental health literacy. Digital mental health interventions may also improve mental health related self-management skills and contribute to symptom reduction and the improvement of quality of life. Objective: This study aims to investigate the effects of a self-guided transdiagnostic app for mental health on help seeking, reduced stigma, mental health literacy, self-management skills, mental health symptoms, and quality of life using a randomized controlled design. Methods: Overall, 1045 participants (recruited via open, blinded, and web-based recruitment) with mild to moderate depression or anxiety-, sleep-, eating-, or somatization-related psychopathology were randomized to receive either access to a self-guided transdiagnostic mental health app (MindDoc) in addition to care as usual or care as usual only. The core features of the app were regular self-monitoring, automated feedback, and psychological courses and exercises. The coprimary outcomes were mental health literacy, mental health–related patient empowerment and self-management skills (MHPSS), attitudes toward help seeking, and actual mental health service use. The secondary outcomes were psychopathological symptom burden and quality of life. Data were collected at baseline and 8 weeks and 6 months after randomization. Treatment effects were investigated using analyses of covariance, including baseline variables as predictors and applying multiple imputation. Results: We found small but robust between-group effects for MHPSS (Cohen d=0.29), symptoms burden (Cohen d=0.28), and quality of life (Cohen d=0.19) 8 weeks after randomization. The effects on MHPSS were maintained at follow-up. Follow-up assessments also showed robust effects on mental health literacy and preliminary evidence for the improvement of help seeking. Predictors of attrition were lower age and higher personality dysfunction. Among the non-attritors, predictors for deterioration were less outpatient treatment and higher initial symptom severity. Conclusions: A self-guided transdiagnostic mental health app can contribute to lasting improvements in patient empowerment. Symptoms of common mental disorders and quality of life improved faster in the intervention group than in the control group. Therefore, such interventions may support individuals with symptoms of 1 or more internalizing disorders, develop health-centered coping skills, prevent chronification, and accelerate symptom improvement. Although the effects for individual users are small and predictors of attrition and deterioration need to be investigated further, the potential public health impact of a self-guided intervention can be large, given its high scalability. Trial Registration: German Clinical Trials Register DRKS00022531; https://drks.de/search/de/trial/DRKS00022531 %M 37930749 %R 10.2196/45068 %U https://mental.jmir.org/2023/1/e45068 %U https://doi.org/10.2196/45068 %U http://www.ncbi.nlm.nih.gov/pubmed/37930749 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e50872 %T Automated Messaging Delivered Alongside Behavioral Treatment for Weight Loss: Qualitative Study %A Berry,Michael %A Taylor,Lauren %A Huang,Zhuoran %A Chwyl,Christina %A Kerrigan,Stephanie %A Forman,Evan %+ Department of Psychological and Brain Sciences, Drexel University, 3141 Chestnut St., Philadelphia, PA, 19103, United States, 1 (267) 961 2578, mpb334@drexel.edu %K mobile health technology %K weight loss %K tailored messaging %K lifestyle modification %K mobile health %K mHealth %K messaging %K weight loss %K intervention %K overweight %K obesity %K qualitative %K thematic analysis %D 2023 %7 6.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Mobile health interventions for weight loss frequently use automated messaging. However, this intervention modality appears to have limited weight loss efficacy. Furthermore, data on users’ subjective experiences while receiving automated messaging–based interventions for weight loss are scarce, especially for more advanced messaging systems providing users with individually tailored, data-informed feedback. Objective: The purpose of this study was to characterize the experiences of individuals with overweight or obesity who received automated messages for 6-12 months as part of a behavioral weight loss trial. Methods: Participants (n=40) provided Likert-scale ratings of messaging acceptability and completed a structured qualitative interview (n=39) focused on their experiences with the messaging system and generating suggestions for improvement. Interview data were analyzed using thematic analysis. Results: Participants found the messages most useful for summarizing goal progress and least useful for suggesting new behavioral strategies. Overall message acceptability was moderate (2.67 out of 5). From the interviews, 2 meta-themes emerged. Participants indicated that although the messages provided useful reminders of intervention goals and skills, they did not adequately capture their lived experiences while losing weight. Conclusions: Many participants found the automated messages insufficiently tailored to their personal weight loss experiences. Future studies should explore alternative methods for message tailoring (eg, allowing for a higher degree of participant input and interactivity) that may boost treatment engagement and efficacy. Trial Registration: ClinicalTrials.gov NCT05231824; https://clinicaltrials.gov/study/NCT05231824 %M 37930786 %R 10.2196/50872 %U https://formative.jmir.org/2023/1/e50872 %U https://doi.org/10.2196/50872 %U http://www.ncbi.nlm.nih.gov/pubmed/37930786 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e48864 %T Digitally Enabled Peer Support Intervention to Address Loneliness and Mental Health: Prospective Cohort Analysis %A Bravata,Dena M %A Kim,Joseph %A Russell,Daniel W %A Goldman,Ron %A Pace,Elizabeth %+ Department of Human Development & Family Studies, Iowa State University, 86 Lebaron Hall, Ames, IA, 50011, United States, 1 515 294 6316, jkim7@iastate.edu %K peer-support %K social isolation %K loneliness %K companionship %K depression %K anxiety %K quality of life %K occupational health %D 2023 %7 6.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Social isolation and loneliness affect 61% of US adults and are associated with significant increases in excessive mental and physical morbidity and mortality. Annual health care spending is US $1643 higher for socially isolated individuals than for those not socially isolated. Objective: We prospectively evaluated the effects of participation with a digitally enabled peer support intervention on loneliness, depression, anxiety, and health-related quality of life among adults with loneliness. Methods: Adults aged 18 years and older living in Colorado were recruited to participate in a peer support program via social media campaigns. The intervention included peer support, group coaching, the ability to become a peer helper, and referral to other behavioral health resources. Participants were asked to complete surveys at baseline, 30, 60, and 90 days, which included questions from the validated University of California, Los Angeles Loneliness Scale, Patient Health Questionnaire 2-Item Scale, General Anxiety Disorder 7-Item Scale, and a 2-item measure assessing unhealthy days due to physical condition and mental condition. A growth curve modeling procedure using multilevel regression analyses was conducted to test for linear changes in the outcome variables from baseline to the end of the intervention. Results: In total, 815 ethnically and socially diverse participants completed registration (mean age 38, SD 12.7; range 18-70 years; female: n=310, 38%; White: n=438, 53.7%; Hispanic: n=133, 16.3%; Black: n=51, 6.3%; n=263, 56.1% had a high social vulnerability score). Participants most commonly joined the following peer communities: loneliness (n=220, 27%), building self-esteem (n=187, 23%), coping with depression (n=179, 22%), and anxiety (n=114, 14%). Program engagement was high, with 90% (n=733) engaged with the platform at 60 days and 86% (n=701) at 90 days. There was a statistically (P<.001 for all outcomes) and clinically significant improvement in all clinical outcomes of interest: a 14.6% (mean 6.47) decrease in loneliness at 90 days; a 50.1% (mean 1.89) decline in depression symptoms at 90 days; a 29% (mean 1.42) reduction in anxiety symptoms at 90 days; and a 13% (mean 21.35) improvement in health-related quality of life at 90 days. Based on changes in health-related quality of life, we estimated a reduction in annual medical costs of US $615 per participant. The program was successful in referring participants to behavioral health educational resources, with 27% (n=217) of participants accessing a resource about how to best support those experiencing psychological distress and 15% (n=45) of women accessing a program about the risks of excessive alcohol use. Conclusions: Our results suggest that a digitally enabled peer support program can be effective in addressing loneliness, depression, anxiety, and health-related quality of life among a diverse population of adults with loneliness. Moreover, it holds promise as a tool for identifying and referring members to relevant behavioral health resources. %M 37930770 %R 10.2196/48864 %U https://formative.jmir.org/2023/1/e48864 %U https://doi.org/10.2196/48864 %U http://www.ncbi.nlm.nih.gov/pubmed/37930770 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e48079 %T A Web-Based Patient Empowerment to Medication Adherence Program for Patients With Rheumatoid Arthritis: Feasibility Randomized Controlled Trial %A Lim,Siriwan %A Athilingam,Ponrathi %A Lahiri,Manjari %A Cheung,Peter Pak Moon %A He,Hong-Gu %A Lopez,Violeta %+ Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 2, Clinical Research Centre, Block MD11, 10 Medical Drive, Singapore, 117597, Singapore, 65 66012759, nursl@nus.edu.sg %K patient empowerment %K rheumatoid arthritis %K intervention %K feasibility study %K adherence %K chronic %K arthritis %K rheumatism %K medication %K prescription %K drug %K mapping %K design %K development %K web based %K internet based %K web-based tool %D 2023 %7 6.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Living with a chronic illness such as rheumatoid arthritis (RA) requires medications and therapies, as well as long-term follow-up with multidisciplinary clinical teams. Patient involvement in the shared decision-making process on medication regimens is an important element in promoting medication adherence. Literature review and needs assessment showed the viability of technology-based interventions to equip patients with knowledge about chronic illness and competencies to improve their adherence to medications. Thus, a web-based intervention was developed to empower patients living with RA to adhere to their disease-modifying antirheumatic drugs (DMARDs) medication regimen. Objective: This study aims to discuss the intervention mapping process in the design of a web-based intervention that supports patient empowerment to medication adherence and to evaluate its feasibility among patients living with RA. Methods: The theory-based Patient Empowerment to Medication Adherence Programme (PE2MAP) for patients with RA was built upon the Zimmerman Psychological Empowerment framework, a web-based program launched through the Udemy website. PE2MAP was developed using a 6-step intervention mapping process: (1) needs assessment, (2) program objectives, (3) conceptual framework to guide the intervention, (4) program plan, (5) adoption, and (6) evaluation involving multidisciplinary health care professionals (HCPs) and a multimedia team. PE2MAP is designed as a 4-week web-based intervention program with a complementary RA handbook. A feasibility randomized controlled trial was completed on 30 participants from the intervention group who are actively taking DMARD medication for RA to test the acceptability and feasibility of the PE2MAP. Results: The mean age and disease duration of the 30 participants were 52.63 and 8.50 years, respectively. The feasibility data showed 87% (n=26) completed the 4-week web-based PE2MAP intervention, 57% (n=17) completed all 100% of the contents, and 27% (n=8) completed 96% to 74% of the contents, indicating the overall feasibility of the intervention. As a whole, 96% (n=24) of the participants found the information on managing the side effects of medications, keeping fit, managing flare-ups, and monitoring joint swelling/pain/stiffness as the most useful contents of the intervention. In addition, 88% (n=23) and 92% (n=24) agreed that the intervention improved their adherence to medications and management of their side effects, including confidence in communicating with their health care team, respectively. The dos and do nots of traditional Chinese medicine were found by 96% (n=25) to be useful. Goal setting was rated as the least useful skill by 6 (23.1%) of the participants. Conclusions: The web-based PE2MAP intervention was found to be acceptable, feasible, and effective as a web-based tool to empower patients with RA to manage and adhere to their DMARD medications. Further well-designed randomized controlled trials are warranted to explore the effectiveness of this intervention in the management of patients with RA. %M 37930758 %R 10.2196/48079 %U https://formative.jmir.org/2023/1/e48079 %U https://doi.org/10.2196/48079 %U http://www.ncbi.nlm.nih.gov/pubmed/37930758 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47189 %T Improving the Usability of Written Exposure Therapy for Therapists in the Department of Veterans Affairs Telemental Health: Formative Study Using Qualitative and User-Centered Design Methods %A Moldestad,Megan %A Petrova,Valentina V %A Tirtanadi,Katie %A Mishra,Sonali R %A Rajan,Suparna %A Sayre,George %A Fortney,John C %A Reisinger,Heather Schacht %+ Seattle-Denver Center of Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound Health Care System, 1660 S Columbian Way, MS-152, Seattle, WA, 98108, United States, 1 206 277 6587, megan.moldestad@va.gov %K evidence-based psychosocial interventions %K telehealth %K qualitative %K user-centered design %K implementation science %K Department of Veterans Affairs health care system %D 2023 %7 6.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: User modifications are common in evidence-based psychosocial interventions (EBPIs) for mental health disorders. Often, EBPIs fit poorly into clinical workflows, require extensive resources, or pose considerable burden to patients and therapists. Implementation science is increasingly researching ways to improve the usability of EBPIs before implementation. A user-centered design can be used to support implementation methods to prioritize user needs and solutions to improve EBPI usability. Objective: Trauma-focused EBPIs are a first-line treatment for patients with posttraumatic stress disorder (PTSD) in the Department of Veterans Affairs. Written exposure therapy (WET) is a brief, trauma-focused EBPI wherein patients handwrite about trauma associated with their PTSD. Initially developed for in-person delivery, WET is increasingly being delivered remotely, and outcomes appear to be equivalent to in-person delivery. However, there are logistical issues in delivering WET via video. In this evaluation, we explored usability issues related to WET telehealth delivery via videoconferencing software and designed a solution for therapist-facing challenges to systematize WET telehealth delivery. Methods: The Discover, Design and Build, and Test framework guided this formative evaluation and served to inform a larger Virtual Care Quality Enhancement Research Initiative. We used qualitative descriptive methods in the Discover phase to understand the experiences and needs of 2 groups of users providing care within the Department of Veterans Affairs: in-person therapists delivering WET via video because of the COVID-19 pandemic and telehealth therapists who regularly deliver PTSD therapies. We then used user-centered design methods in the Design and Build phase to brainstorm, develop, and iteratively refine potential workflows to address identified usability issues. All procedures were conducted remotely. Results: In the Discover phase, both groups had challenges delivering WET and other PTSD therapies via telehealth because of technology issues with videoconferencing software, environmental distractions, and workflow disruptions. Narrative transfer (ie, patients sending handwritten trauma accounts to therapists) was the first target for design solution development as it was deemed most critical to WET delivery. In the Design and Build phase, we identified design constraints and brainstormed solution ideas. This led to the development of 3 solution workflows that were presented to a subgroup of therapist users through cognitive walkthroughs. Meetings with this subgroup allowed workflow refinement to improve narrative transfers. Finally, to facilitate using these workflows, we developed PDF manuals that are being refined in subsequent phases of the implementation project (not mentioned in this paper). Conclusions: The Discover, Design and Build, and Test framework can be a useful tool for understanding user needs in complex EBPI interventions and designing solutions to user-identified usability issues. Building on this work, an iterative evaluation of the 3 solution workflows and accompanying manuals with therapists and patients is underway as part of a nationwide WET implementation in telehealth settings. %M 37930747 %R 10.2196/47189 %U https://formative.jmir.org/2023/1/e47189 %U https://doi.org/10.2196/47189 %U http://www.ncbi.nlm.nih.gov/pubmed/37930747 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48329 %T A Web-Based Mindfulness-Based Cognitive Therapy for Couples Dealing With Chronic Cancer-Related Fatigue: Protocol for a Single-Arm Pilot Trial %A Müller,Fabiola %A van Dongen,Sophie %A van Woezik,Rosalie %A Tibosch,Marijke %A Tuinman,Marrit A %A Schellekens,Melanie P J %A Laurenceau,Jean-Philippe %A van der Lee,Marije %A Hagedoorn,Mariët %+ Department of Health Psychology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, HPC FA12, Groningen, 9700 RB, Netherlands, 31 50 361 6669, f.muller@umcg.nl %K acceptability %K cancer %K chronic cancer-related fatigue %K couple intervention %K eMBCT %K fatigue %K feasibility %K partners %K pilot trial %K web-based mindfulness-based cognitive therapy %D 2023 %7 6.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic fatigue is a common symptom among patients who have been treated for cancer. Current psychosocial interventions typically target the patient alone, despite growing evidence suggesting that a couples’ approach can increase and broaden the efficacy of an intervention. Therefore, based on an existing web-based mindfulness-based cognitive therapy for patients, the couple intervention COMPANION was developed. Objective: The primary objectives of this study are to determine the acceptability of COMPANION and its potential efficacy in reducing fatigue in patients with cancer. Our secondary objectives are to examine the feasibility of the trial procedures and the potential working mechanisms of the couple intervention. Methods: We will conduct a single-arm pilot trial for couples (ie, patients with cancer with chronic fatigue and their partners). All couples are allocated to the web-based couple intervention that consists of psychoeducation, mindfulness, and cognitive-behavioral exercises. The 9 sessions of the intervention are supervised remotely by a trained therapist. Patients and partners will complete questionnaires before starting the intervention (T0), 2 weeks after completing the intervention (T1), and 1 month after T1 (T2). They will also fill out weekly diaries during the intervention period. A subsample of patients (n≈5) and partners (n≈5) as well as all the therapists providing COMPANION will participate in the final focus groups. Benchmark values have been defined to determine the acceptability (ie, ≥60% of couples complete the intervention and/or ≥70% of the participants are satisfied with the intervention) and potential efficacy (ie, a significant improvement in fatigue and/or a clinically relevant improvement in fatigue in 45% of the patients between T0 and T1) of the intervention. The trial procedures are deemed feasible if an average of at least three couples are included per recruiting month and/or adherence to the assessments is at least 65% for T1 and the diaries and 60% for T2. To establish potential working mechanisms, changes in affect, sleep, catastrophizing, partner communication and interactions, self-efficacy, mindfulness, and closeness will be examined. Quantitative outcomes will be interpreted along with the results from the focus groups. Results: Data collection is expected to be completed by March 2024. Conclusions: This pilot trial will test the first web-based mindfulness-based cognitive therapy for couples targeting chronic cancer-related fatigue. Findings will indicate whether proceeding with a randomized controlled trial is warranted. Trial Registration: ClinicalTrials.gov NCT05636696; https://clinicaltrials.gov/study/NCT05636696 International Registered Report Identifier (IRRID): DERR1-10.2196/48329 %M 37930767 %R 10.2196/48329 %U https://www.researchprotocols.org/2023/1/e48329 %U https://doi.org/10.2196/48329 %U http://www.ncbi.nlm.nih.gov/pubmed/37930767 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e48404 %T Freely Available Training Videos for Suicide Prevention: Scoping Review %A Wislocki,Katherine %A Jager-Hyman,Shari %A Brady,Megan %A Weiss,Michal %A Schaechter,Temma %A Khazanov,Gabriela %A Young,Sophia %A Becker-Haimes,Emily %+ Department of Psychological Science, University of California, Irvine, 214 Pereira Drive, Irvine, CA, 92617, United States, 1 9498246803, kwislock@uci.edu %K freely available videos %K asynchronous training %K suicide prevention %K evidence-based practice %K dissemination %K implementation %D 2023 %7 3.11.2023 %9 Review %J JMIR Ment Health %G English %X Background: Freely available and asynchronous implementation supports can reduce the resource burden of evidence-based practice training to facilitate uptake. Freely available web-based training videos have proliferated, yet there have been no efforts to quantify their breadth, depth, and content for suicide prevention. Objective: This study presents results from a scoping review of freely available training videos for suicide prevention and describes a methodological framework for reviewing such videos. Methods: A scoping review of freely available training videos (≥2 minutes) for suicide prevention practices was conducted using 4 large video-sharing platforms: YouTube, Vimeo, Bing Video, and Google Video. Identified suicide prevention training videos (N=506) were reviewed and coded. Results: Most content was targeted toward gatekeepers or other lay providers (n=370) versus clinical providers (n=136). Videos most commonly provided content related to suicidal thoughts or behaviors (n=420). Many videos (n=274, 54.2%) included content designed for certain communities or organizations. Less than half (n=232, 45.8%) of training videos included formal clinical content pertaining to assessment or intervention for suicide prevention. Conclusions: Results suggested an abundance of videos providing broad informational content (eg, “signs and symptoms of someone at risk for suicide”) and a limited portion of videos with instructional content aimed at clinical providers delivering formal evidence-based assessments or interventions for suicide prevention. Development of resources to address identified gaps may be needed. Future work may leverage machine learning techniques to expedite the review process. %M 37921847 %R 10.2196/48404 %U https://mental.jmir.org/2023/1/e48404 %U https://doi.org/10.2196/48404 %U http://www.ncbi.nlm.nih.gov/pubmed/37921847 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 11 %N %P e46912 %T A Video Game Intervention to Prevent Opioid Misuse Among Older Adolescents: Development and Preimplementation Study %A Aneni,Kammarauche %A Fernandes,Claudia-Santi F %A Hoerner,Lily A %A Szapary,Claire %A Pendergrass Boomer,Tyra M %A Fiellin,Lynn E %+ Department of Internal Medicine, Yale University School of Medicine, 2 Church Street South, Suite 515, New Haven, CT, 06519, United States, 1 203 785 2885, lynn.sullivan@yale.edu %K videogames %K serious games %K opioid misuse %K mental health %K adolescents %D 2023 %7 3.11.2023 %9 Original Paper %J JMIR Serious Games %G English %X Background: Opioid misuse and mental disorders are highly comorbid conditions. The ongoing substance misuse and mental health crises among adolescents in the United States underscores the importance of widely scalable substance misuse preventive interventions that also address mental health risks. Serious video games offer an engaging, widely scalable method for delivering and implementing preventive interventions. However, there are no video game interventions that focus on preventing opioid misuse among older adolescents, and there are limited existing video game interventions that address mental health. Objective: This study aims to develop and conduct a formative evaluation of a video game intervention to prevent opioid misuse and promote mental health among adolescents aged 16-19 years (PlaySmart). We conducted formative work in preparation for a subsequent randomized controlled trial. Methods: We conducted development and formative evaluation of PlaySmart in 3 phases (development, playtesting, and preimplementation) through individual interviews and focus groups with multiple stakeholders (adolescents: n=103; school-based health care providers: n=51; and addiction treatment providers: n=6). PlaySmart content development was informed by the health belief model, the theory of planned behavior, and social cognitive theory. User-centered design principles informed the approach to development and play testing. The Exploration, Preparation, Implementation, and Sustainability framework informed preimplementation activities. Thematic analysis was used to identify themes from interviews and focus groups that informed PlaySmart game content and approaches to future implementation of PlaySmart. Results: We developed a novel video game PlaySmart for older adolescents that addresses the risk and protective factors for opioid misuse and mental health. Nine themes emerged from the focus groups that provided information regarding game content. Playtesting revealed areas of the game that required improvement, which were modified for the final game. Preimplementation focus groups identified potential barriers and facilitators for implementing PlaySmart in school settings. Conclusions: PlaySmart offers a promising digital intervention to address the current opioid and mental health crises among adolescents in a scalable manner. %M 37921851 %R 10.2196/46912 %U https://games.jmir.org/2023/1/e46912 %U https://doi.org/10.2196/46912 %U http://www.ncbi.nlm.nih.gov/pubmed/37921851 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e51824 %T Video-Delivered Family Therapy for Perinatal Women With Depressive Symptoms and Family Conflict: Feasibility, Acceptability, Safety, and Tolerability Results From a Pilot Randomized Trial %A Cluxton-Keller,Fallon %A Hegel,Mark T %A Donnelly,Craig L %A Bruce,Martha L %+ Department of Psychiatry, Geisel School of Medicine at Dartmouth, One Medical Center Drive, Lebanon, NH, 03756, United States, 1 603 650 4726, Fallon.P.Cluxton-Keller@dartmouth.edu %K perinatal depression %K family conflict %K family therapy %K family %K conflict %K depression %K depressive %K perinatal %K pregnant %K pregnancy %K video %K videos %K feasibility %K safety %K acceptability %K tolerability %K tolerable %K families %K satisfaction %K resilience %K psychotherapy %D 2023 %7 3.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Although individual-level treatments exist for pregnant and postpartum women with depression, family conflict is a significant factor that can contribute to the development and severity of perinatal depressive symptoms. Yet, there is a lack of research on family therapy for perinatal women with moderate to severe depressive symptoms and family conflict. Further, research is needed on the feasibility, acceptability, safety, and tolerability of family therapies for perinatal depression that are delivered using Health Insurance Portability and Accountability Act–compliant videoconferencing technology (VCT). Objective: This paper describes the feasibility, acceptability, safety, and tolerability of a VCT-based family therapeutic intervention, Resilience Enhancement Skills Training (REST), for perinatal women with moderate to severe depressive symptoms and moderate to high conflict with their family members. Methods: This paper includes data from an ongoing randomized trial that compares an experimental family therapeutic intervention (REST) to standard of care (VCT-based problem-solving individual therapy) for the treatment of moderate to severe depressive symptoms in perinatal women with moderate to high family conflict. Both interventions were delivered by masters-level therapists using VCT. A total of 83 perinatal women and their adult family members (N=166 individuals) were recruited for participation in the study. Feasibility, defined as therapist adherence to ≥80% of REST session content, was assessed in audio-recorded sessions by 2 expert raters. Acceptability was defined as ≥80% of families completing REST, including completion of ≥80% homework assignments and family report of satisfaction with REST. Completion of REST was assessed by review of therapist session notes, and satisfaction was assessed by participant completion of a web-based questionnaire. The Beck Depression Inventory-Second Edition was administered to perinatal women by research assistants (blind to study group assignment) to assess safety, defined as a reduction in depressive symptoms during the treatment phase. The Family Environment Scale-Family Conflict subscale was administered by therapists to participants during the treatment phase to assess tolerability, defined as a reduction in family conflict during the treatment phase. Results: On average, the therapists achieved 90% adherence to REST session content. Of the families who started REST, 84% (32/38) of them completed REST, and on average, they completed 89% (8/9) of the homework assignments. Families reported satisfaction with REST. The results showed that REST is safe for perinatal women with moderate to severe depressive symptoms, and none discontinued due to worsened depressive symptoms. The results showed that REST is well tolerated by families, and no families discontinued due to sustained family conflict. Conclusions: The results show that REST is feasible, acceptable, safe, and tolerable for families. These findings will guide our interpretation of REST’s preliminary effectiveness upon completion of outcome data collection. Trial Registration: ClinicalTrials.gov NCT04741776; https://clinicaltrials.gov/ct2/show/NCT04741776 %M 37921846 %R 10.2196/51824 %U https://formative.jmir.org/2023/1/e51824 %U https://doi.org/10.2196/51824 %U http://www.ncbi.nlm.nih.gov/pubmed/37921846 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e50304 %T Creating an Intercultural User-Centric Design for a Digital Sexual Health Education App for Young Women in Resource-Poor Regions of Kenya: Qualitative Self-Extended Double Diamond Model for Requirements Engineering Analysis %A Soehnchen,Clarissa %A Rietz,Annika %A Weirauch,Vera %A Meister,Sven %A Henningsen,Maike %+ HealthCare Department, Fraunhofer Institute for Software and System Engineering, Speicherstraße 6, Dortmund, 44147, Germany, 49 2302926, clarissa.soehnchen@uni-wh.de %K sexual health information %K sexual health education %K sub-Saharan Africa %K women %K semistructured interviews %K requirements engineering analysis %K user-centered design %K youth, slum %K health education %K sexual health %K digital health %K stigmatization %K reproductive health services %D 2023 %7 3.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The stigmatization around sexual health due to culture, religious traditions, and norms leads to myths and a lack of available information and resources related to universal access to sexual and reproductive health services. Additional sexual health education not being part of the Kenya school curriculum leads to insufficient access to knowledge about safe contraception, menstruation, and female genital mutilation. A digital app could support and provide education and information for universal equal access, addressing United Nations Sustainable Development Goals 3, 4, and 5. Objective: The study targeted the requirements for establishing a reusable framework to develop a successful accessible web-based sexual health education app and the behavioral intention to use it to obtain sexual health information by mainly young women in Kenya. Methods: The double diamond model, with a problem room including the discover and define phases, enriched with cultural aspects and modeled to a self-expanded intercultural research model was used in a user-centered design thinking approach to develop a framework for requirements engineering analysis. For problem identification, semistructured pilot phase interviews based on Consolidated Criteria for Reporting Qualitative Research guidelines were conducted, followed by expert interviews for qualitative content analysis. A sample size of 12 pilot phase interviews and 5 expert interviews was determined using data saturation. The responses were coded and analyzed according to the affinity mapping method. Results: The requirements engineering analysis showed potential enablers of and barriers to the use of a digital sexual health education app. Through this qualitative study, a conservative cultural background, classic text communication, and the influence of social affiliation within society were identified as barriers, which should be enhanced through visual and auditory channels as well as a fictional character in the app. Conclusions: The developed intercultural research model provides an impetus to providing digital sexual health education, integrating culture-specific aspects in the design process, while focusing on cultural and religious stigmata. The reusable framework enables identifying and overcoming hurdles in providing information about taboo and intimate topics. The overall use of online education tools focusing on intimate topics is correlated with accessibility and understanding specific cultural needs while delivering content on a basic and comprehensive level. It helps the target user from a social conservative background and in resource-poor circumstances to benefit from a digital educational solution. %M 37921860 %R 10.2196/50304 %U https://formative.jmir.org/2023/1/e50304 %U https://doi.org/10.2196/50304 %U http://www.ncbi.nlm.nih.gov/pubmed/37921860 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e49846 %T Developing a Theory of Change for a Digital Youth Mental Health Service (Moderated Online Social Therapy): Mixed Methods Knowledge Synthesis Study %A Cross,Shane %A Nicholas,Jennifer %A Mangelsdorf,Shaminka %A Valentine,Lee %A Baker,Simon %A McGorry,Patrick %A Gleeson,John %A Alvarez-Jimenez,Mario %+ Orygen, 35 Poplar Rd, Parkville, Melbourne, 3052, Australia, 61 3 9966 9383, shane.cross@orygen.org.au %K adolescence %K adolescent %K blended care %K blended %K co-design %K development %K digital health %K digital intervention %K digital mental health %K framework %K hybrid %K mental health %K model %K platform %K self-determination theory %K service %K services %K theory of change %K therapy %K youth mental health %K youth %D 2023 %7 3.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Common challenges in the youth mental health system include low access, poor uptake, poor adherence, and limited overall effectiveness. Digital technologies offer promise, yet challenges in real-world integration and uptake persist. Moderated Online Social Therapy (MOST) aims to overcome these problems by integrating a comprehensive digital platform into existing youth mental health services. Theory of change (ToC) frameworks can help articulate how and why complex interventions work and what conditions are required for success. Objective: The objective of this study is to create a ToC for MOST to explain how it works, why it works, who benefits and how, and what conditions are required for its success. Methods: We used a multimethod approach to construct a ToC for MOST. The synthesis aimed to assess the real-world impact of MOST, a digital platform designed to enhance face-to-face youth mental health services, and to guide its iterative refinement. Data were gathered from 2 completed and 4 ongoing randomized controlled trials, 11 pilot studies, and over 1000 co-design sessions using MOST. Additionally, published qualitative findings from diverse clinical contexts and a review of related digital mental health literature were included. The study culminated in an updated ToC framework informed by expert feedback. The final ToC was produced in both narrative and table form and captured components common in program logic and ToC frameworks. Results: The MOST ToC captured several assumptions about digital mental health adoption, including factors such as the readiness of young people and service providers to embrace digital platforms. External considerations included high service demand and a potential lack of infrastructure to support integration. Young people and service providers face several challenges and pain points MOST seeks to address, such as limited accessibility, high demand, poor engagement, and a lack of personalized support. Self-determination theory, transdiagnostic psychological treatment approaches, and evidence-based implementation theories and their associated mechanisms are drawn upon to frame the intervention components that make up the platform. Platform usage data are captured and linked to short-, medium-, and long-term intended outcomes, such as reductions in mental health symptoms, improvements in functioning and quality of life, reductions in hospital visits, and reduced overall mental health care costs. Conclusions: The MOST ToC serves as a strategic framework for refining MOST over time. The creation of the ToC helped guide the development of therapeutic content personalization, user engagement enhancement, and clinician adoption through specialized implementation frameworks. While powerful, the ToC approach has its limitations, such as a lack of standardized methodology and the amount of resourcing required for its development. Nonetheless, it provides an invaluable roadmap for iterative development, evaluation, and scaling of MOST and offers a replicable model for other digital health interventions aiming for targeted, evidence-based impact. %M 37921858 %R 10.2196/49846 %U https://formative.jmir.org/2023/1/e49846 %U https://doi.org/10.2196/49846 %U http://www.ncbi.nlm.nih.gov/pubmed/37921858 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e44907 %T A Guided Web-Based Intervention Targeting Procrastination in College Students: Protocol for an Open Trial %A Ozmen,Sevin %A Amarnath,Arpana %A Struijs,Sascha %A de Wit,Leonore %A Cuijpers,Pim %+ Department of Clinical Psychology, Vrije Universiteit Amsterdam, De Boelelaan 1105, Amsterdam, 1081 HV, Netherlands, 31 205989898, s.ozmen@vu.nl %K eHealth %K feasibility %K guidance %K online intervention %K procrastination %K protocol %D 2023 %7 3.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Academic procrastination is a widespread problem among college students. It is linked to poor academic performance and increased college dropout intentions, as well as several mental health problems such as depression, anxiety, and stress. Guided web-based interventions can help reduce procrastination. However, guidance by professional clinicians draws upon valuable and limited societal resources, and a more efficient, scalable form of guidance is needed. Guidance by trained clinical psychology students has not yet been examined. Objective: The aim of this open trial is to examine the feasibility and acceptability of a web-based procrastination intervention for college students under the guidance of student digital coaches (e-coaches). Methods: We developed a single-arm trial of a guided web-based intervention targeting procrastination for the Dutch student population. Guidance is delivered by trained clinical psychology students asynchronously in the form of textual feedback on intervention progress, with the aim of supporting and motivating the participant. Participants are recruited at 7 Dutch universities. Primary outcomes are intervention satisfaction, usability, and adherence, which are assessed by the Client Satisfaction Scale (CSQ-8), System Usability Scale (SUS-10), and number of completed modules, respectively. The primary outcomes will be examined by calculating descriptive statistics. Secondary outcomes are e-coach satisfaction and changes to procrastination, depression, stress, and quality of life from pre- to posttest and follow-up. Results: The project was funded in 2019, and recruitment began in January 2021. As of May 2023, a total of 985 participants were enrolled, of which 372 had completed the posttest and 192 had completed the follow-up. The expected date of analysis and publication of the results is 2024. Conclusions: The results are expected to contribute to the body of literature regarding eHealth in 3 ways. First, we will examine whether students who procrastinate adhere to and are satisfied with an eHealth intervention targeting this problem. Second, we will explore whether an intervention targeting procrastination can also decrease depression and stress. Lastly, we will investigate whether trained psychology students can effectively guide their peers in web-based interventions. Given the shortage of licensed psychologists, exploring alternative sources of guidance is much needed in order to provide students with the mental health support they need. International Registered Report Identifier (IRRID): DERR1-10.2196/44907 %M 37921841 %R 10.2196/44907 %U https://www.researchprotocols.org/2023/1/e44907 %U https://doi.org/10.2196/44907 %U http://www.ncbi.nlm.nih.gov/pubmed/37921841 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e50833 %T An eHealth Prevention Program for Substance Use, Sexual Assault, and Sexual Risk Behaviors for Adolescents in Primary Care: Pilot Feasibility Randomized Controlled Trial of Teen Well Check %A Gilmore,Amanda K %A Fortson,Kennicia %A Mullican,K Nicole %A García-Ramírez,Grisel %A Hutchins,Anna %A Bartlett,Alyssa M %A Gooding,Holly C %A Wallis,Elizabeth %A Levy,Sharon %A Ruggiero,Kenneth J %A Kaysen,Debra %A Danielson,Carla Kmett %A Platner,Robert %A Hartman,April %A Self-Brown,Shannon %+ Department of Health Policy & Behavioral Sciences, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA, 30302, United States, agilmore12@gsu.edu %K prevention %K adolescents %K eHealth %K drug use %K sexual assault %K sexual health %D 2023 %7 2.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Substance use, sexual assault, and sexual risk behaviors are common among adolescents and are interrelated. Nearly 1 in 5 adolescents use substances before sexual encounters, placing these young people at risk for both sexual assault and sexual risk behaviors. Primary care visits present a unique opportunity to address multiple health risk behaviors. Objective: Teen Well Check is a web-based integrated prevention program for substance use, sexual assault, and sexual risk behaviors with demonstrated usability and acceptability among patients and providers. The aim of this study was to conduct a pilot randomized controlled trial to assess feasibility. Methods: Adolescents (n=123) aged 14 to 18 years from diverse backgrounds were recruited from primarily Medicaid-serving pediatric primary care clinics. Participants completed a baseline survey; were randomized to receive Teen Well Check or an assessment-only control; and completed 1-, 3-, and 6-month follow-up surveys. Feasibility was assessed in terms of recruitment and retention rates. Preliminary changes from baseline to follow-up periods were examined separately in the Teen Well Check and control conditions. Results: We recruited 123 participants (Teen Well Check: n=61, 49.6%; control: n=62, 50.4%). Of the 61 participants assigned to the Teen Well Check condition, 55 (90%) completed the full program and viewed all intervention content. Of the 123 participants, 105 (85.4%) were retained across at least 1 follow-up period, and there was no difference in follow-up rates between the conditions (χ21=0.6; P=.43). The completion of Teen Well Check took an average of 6.2 (SD 5.8) minutes. Preliminary analyses revealed that there were significant reductions in perceived peer norms (descriptive norms) for substance use before sex across follow-ups among participants in the Teen Well Check condition (P=.001 from baseline to 6 months), whereas there were significant increases among participants in the control condition (P=.003 from baseline to 6 months). In addition, there were nonsignificant reductions in substance misuse risk from baseline to the 6-month follow-up among participants in the Teen Well Check condition (P=.16). Conclusions: These findings support the feasibility of Teen Well Check delivery within pediatric primary care clinics. A randomized clinical trial is needed to assess efficacy. Trial Registration: ClinicalTrials.gov NCT3489434; https://www.clinicaltrials.gov/study/NCT03489434 %M 37917146 %R 10.2196/50833 %U https://formative.jmir.org/2023/1/e50833 %U https://doi.org/10.2196/50833 %U http://www.ncbi.nlm.nih.gov/pubmed/37917146 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e49809 %T Behavioral Activation–Based Digital Smoking Cessation Intervention for Individuals With Depressive Symptoms: Randomized Clinical Trial %A Dahne,Jennifer %A Wahlquist,Amy E %A Kustanowitz,Jacob %A Natale,Noelle %A Fahey,Margaret %A Graboyes,Evan M %A Diaz,Vanessa A %A Carpenter,Matthew J %+ Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 86 Jonathan Lucas Street, MSC 955, Charleston, SC, 29425, United States, 1 8438762280, dahne@musc.edu %K smoking cessation %K depression %K digital health %K decentralized trial %K mental health %K depressive %K RCT %K randomized %K controlled trial %K smoking %K smoke %K smoker %K quit %K quitting %K cessation %K digital health %K eHealth %K e-health %K NRT %K nicotine %K mobile health %K mHealth %K app %K apps %K application %K applications %D 2023 %7 1.11.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression is common among adults who smoke cigarettes. Existing depression-specific cessation interventions have limited reach and are unlikely to improve smoking prevalence rates among this large subgroup of smokers. Objective: This study aimed to determine whether a mobile app–based intervention tailored for depression paired with a mailed sample of nicotine replacement therapy (NRT) is efficacious for treating depression and promoting smoking cessation. Methods: A 2-arm nationwide remote randomized clinical trial was conducted in the United States. Adults (N=150) with elevated depressive symptoms (Patient Health Questionnaire-8≥10) who smoked were enrolled. The mobile app (“Goal2Quit”) provided behavioral strategies for treating depression and quitting smoking based on Behavioral Activation Treatment for Depression. Goal2Quit participants also received a 2-week sample of combination NRT. Treatment as usual participants received a self-help booklet for quitting smoking that was not tailored for depression. Primary end points included Goal2Quit usability, change in depression (Beck Depression Inventory-II) across 12 weeks, and smoking cessation including reduction in cigarettes per day, incidence of 24-hour quit attempts, floating abstinence, and 7-day point prevalence abstinence (PPA). Results: In total, 150 participants were enrolled between June 25, 2020, and February 23, 2022, of which 80 were female (53.3%) and the mean age was 38.4 (SD 10.3) years. At baseline, participants on average reported moderate depressive symptoms and smoked a mean of 14.7 (SD 7.5) cigarettes per day. Goal2Quit usability was strong with a mean usability rating on the System Usability Scale of 78.5 (SD 16.9), with 70% scoring above the ≥68 cutoff for above-average usability. Retention data for app use were generally strong immediately following trial enrollment and declined in subsequent weeks. Those who received Goal2Quit and the NRT sample reported lower mean depressive symptoms over the trial duration as compared to treatment as usual (difference of mean 3.72, SE 1.37 points less; P=.01). Across time points, all cessation outcomes favored Goal2Quit. Regarding abstinence, Goal2Quit participants reported significantly higher rates of 7-day PPA at weeks 4 (11% vs 0%; P=.02), 8 (7-day PPA: 12% vs 0%; P=.02), and 12 (16% vs 2%; P=.02). Conclusions: A mobile app intervention tailored for depression paired with a sample of NRT was effective for depression treatment and smoking cessation. Findings support the utility of this intervention approach for addressing the currently unmet public health treatment need for tailored, scalable depression-specific cessation treatments. Trial Registration: ClinicalTrials.gov NCT03837379; https://clinicaltrials.gov/ct2/show/NCT03837379 %M 37910157 %R 10.2196/49809 %U https://www.jmir.org/2023/1/e49809 %U https://doi.org/10.2196/49809 %U http://www.ncbi.nlm.nih.gov/pubmed/37910157 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e52199 %T The Influence of Branched-Chain Amino Acid Supplementation on Fatigue and Tryptophan Metabolism After Acute and Chronic Exercise in Older Adults: Protocol for a Pilot Randomized Controlled Trial %A Robbins,Ronna N %A Cortes,Tiffany %A O'Connor,Jason C %A Jiwani,Rozmin %A Serra,Monica C %+ Department of Nutrition and Food Science, Texas Woman's University, 304 Adminstration Dr, Denton, TX, 76204, United States, 1 940 898 2737, r.robbins@utexas.edu %K branched-chain amino acids %K kynurenine %K fatigue %K older adults %K exercise %D 2023 %7 1.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Fatigue is a strong predictor of negative health outcomes in older adults. Kynurenine, a metabolite of tryptophan, is strongly associated with fatigue. Reductions in fatigue are observed with exercise; however, exercise training does not completely alleviate symptoms. Branched-chain amino acids (BCAAs) have been shown to have advantageous effects on exercise performance and compete with kynurenine for transport into the central nervous system. Thus, the combination of BCAA and exercise may exert synergized effects of mental and physical fatigue. Therefore, we hypothesize that BCAA added to exercise will shift kynurenine metabolism toward enhanced synthesis of kynurenic acid, thereby reducing fatigue. Objective: This randomized, double-blind, placebo-controlled trial aims to compare the effects of acute (approximately 45 min) and chronic (8 wk) exercise with and without BCAA supplementation on mental and physical fatigue and assess whether the hypothesized outcomes are modulated by changes in kynurenine metabolism in 30 older adults (n=15, 50% per group). Methods: Older adults (aged 60-80 y) who do not exercise >2 days per week and self-report fatigue (≥3 on a scale of 1-10) will be recruited. Participants will be randomized to either the exercise+BCAA group or exercise+placebo group. Participants will engage in high-volume, moderate-intensity, whole-body exercise training (aerobic and resistance exercise; either in-person or web-based sessions) 3 times per week for 8 weeks. In addition, participants will consume daily either 100 mg/kg body weight of BCAA (2:1:1 leucine:isoleucine:valine) or placebo (maltodextrin) throughout the 8-week intervention. BCAA and placebo powders will be identical in color and dissolved in 400 mL of water and 2.5 g of a calorie-free water flavor enhancer. Muscle biopsies will be collected before and after the intervention after a 12-hour fast to examine changes in the biomarkers of tryptophan metabolism and inflammation. Our primary outcomes include changes in mental and physical fatigue and metabolism after the 8-week exercise training between the 2 groups. Mental and physical fatigue will be measured before and after the intervention. Mental fatigue will be subjectively assessed through the completion of validated questionnaires. Physical fatigue will be measured by isometric handgrip, 1-repetition maximum, chair rise, 400-meter walk, and cardiopulmonary exercise tests. Results: The study was funded in March 2022, with an anticipated projected data collection period lasting from January 2023 through December 2023. Conclusions: The discovery that kynurenine concentrations are associated with fatigue and are responsive to BCAA supplementation during exercise training could have important implications for the development of future interventions, both lifestyle and pharmacologic, to treat fatigue in older adults. Trial Registration: ClinicalTrials.gov NCT05484661; https://www.clinicaltrials.gov/study/NCT05484661 International Registered Report Identifier (IRRID): DERR1-10.2196/52199 %M 37910166 %R 10.2196/52199 %U https://www.researchprotocols.org/2023/1/e52199 %U https://doi.org/10.2196/52199 %U http://www.ncbi.nlm.nih.gov/pubmed/37910166 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46890 %T Digital, Crowdsourced, Multilevel Intervention to Promote HIV Testing Among Men Who Have Sex With Men: Cluster Randomized Controlled Trial %A Lin,Yuxi %A Ren,Ci %A Liao,Meizhen %A Kang,Dianmin %A Li,Chuanxi %A Jiao,Kedi %A Wang,Lin %A Yan,Yu %A Li,Yijun %A Wu,Taoyu %A Cheng,Chunxiao %A Zhao,Zhe %A Xu,Zece %A Tang,Weiming %A Tucker,Joseph D %A Ma,Wei %+ Department of Epidemiology, School of Public Health, Cheeloo College of Medicine, Shandong University, 44 West Wenhua Road, Jinan, 250012, China, 86 531 88382141 ext 8803, weima@sdu.edu.cn %K men who have sex with men %K HIV testing %K digital intervention %K multilevel intervention %K cluster randomized controlled trial %K China %D 2023 %7 30.10.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite great efforts in HIV prevention worldwide, HIV testing uptake among men who have sex with men (MSM) remains suboptimal. The effectiveness of digital, crowdsourced, multilevel interventions in improving HIV testing is still unclear. Objective: The aim of this study was to evaluate the effect of a digital, crowdsourced, multilevel intervention in improving HIV testing uptake among MSM in China. Methods: We conducted a 2-arm cluster randomized controlled trial among MSM in 11 cities in Shandong province, China, from August 2019 to April 2020. Participants were men who were HIV seronegative or had unknown serum status, had anal sex with a man in the past 12 months, and had not been tested for HIV in the past 3 months. Participants were recruited through a gay dating app and community-based organizations from preselected cities; these cities were matched into 5 blocks (2 clusters per block) and further randomly assigned (1:1) to receive a digital, crowdsourced, multilevel intervention (intervention arm) or routine intervention (control arm). The digital multilevel intervention was developed through crowdsourced open calls tailored for MSM, consisting of digital intervention images and videos, the strategy of providing HIV self-testing services through digital tools, and peer-moderated discussion within WeChat groups. The primary outcome was self-reported HIV testing uptake in the previous 3 months. An intention-to-treat approach was used to examine the cluster-level effect of the intervention in the 12-month study period using generalized linear mixed models and the individual-level effect using linear mixed models. Results: A total of 935 MSM were enrolled (404 intervention participants and 531 controls); 751 participants (80.3%) completed at least one follow-up survey. Most participants were younger than 30 years (n=601, 64.3%), single (n=681, 72.8%), had a college degree or higher (n=629, 67.3%), and had an HIV testing history (n=785, 84%). Overall, the proportion of testing for HIV in the past 3 months at the 3-, 6-, 9-, and 12-month follow-ups was higher in the intervention arm (139/279, 49.8%; 148/266, 55.6%; 189/263, 71.9%; and 171/266, 64.3%, respectively) than the control arm (183/418, 43.8%; 178/408, 43.6%; 206/403, 51.1%; and 182/397, 48.4%, respectively), with statistically significant differences at the 6-, 9-, and 12-month follow-ups. At the cluster level, the proportion of participants who had tested for HIV increased 11.62% (95% CI 0.74%-22.5%; P=.04) with the intervention. At the individual level, participants in the intervention arm had 69% higher odds for testing for HIV in the past 3 months compared with control participants, but the result was not statistically significant (risk ratio 1.69, 95% CI 0.87-3.27; P=.11). Conclusions: The intervention effectively improved HIV testing uptake among Chinese MSM. Our findings highlight that digital, crowdsourced, multilevel interventions should be made more widely available for HIV prevention and other public health issues. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900024350; http://www.chictr.org.cn/showproj.aspx?proj=36718. International Registered Report Identifier (IRRID): RR2-10.1186/s13063-020-04860-8 %M 37902831 %R 10.2196/46890 %U https://www.jmir.org/2023/1/e46890 %U https://doi.org/10.2196/46890 %U http://www.ncbi.nlm.nih.gov/pubmed/37902831 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e51474 %T The Web-Based Pain-at-Work Toolkit With Telephone Support for Employees With Chronic or Persistent Pain: Protocol for a Cluster Randomized Feasibility Trial %A Blake,Holly %A Chaplin,Wendy J %A Wainwright,Elaine %A Taylor,Gordon %A McNamee,Paul %A McWilliams,Daniel %A Abbott-Fleming,Victoria %A Holmes,Jain %A Fecowycz,Aaron %A Walsh,David Andrew %A Walker-Bone,Karen %+ School of Health Sciences, University of Nottingham, University of Nottingham Medical School, Queen's Medical Centre, Nottingham, NG7 2HA, United Kingdom, holly.blake@nottingham.ac.uk %K eHealth %K chronic pain %K disability %K workplace %K randomized controlled trial %K feasibility %D 2023 %7 30.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic or persistent pain affects one’s ability to work or be productive at work, generating high societal and economic burden. However, the provision of work-related advice and support for people with chronic pain is variable or lacking. The Pain-at-Work (PAW) Toolkit was cocreated with people who live with pain, health care professionals, and employers. It aims to increase knowledge about employee rights and how to access support for managing a painful chronic condition in the workplace and provides advice on lifestyle behaviors that facilitate the management of chronic pain. Objective: We aimed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing access to the PAW Toolkit and telephone support calls from an occupational therapist (PAW) with treatment as usual (ie, standard support from their employer). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, and safety of this digital workplace health intervention. We will assess the candidate primary and secondary outcomes’ feasibility and test research processes for a definitive trial. Methods: This is an open-label, parallel 2-arm pragmatic feasibility cluster randomized controlled trial with exploratory health economics analysis and a nested qualitative interview study. We aim to recruit 120 participants from at least 8 workplace clusters (any type, >10 employees) in England. The recruitment of workplaces occurs via personal approach, and the recruitment of individual participants is web based. Eligible participants are vocationally active adults aged ≥18 years with internet access and self-reporting chronic pain interfering with their ability to undertake or enjoy productive work. A restricted 1:1 cluster-level randomization is used to allocate employment settings to PAW or treatment as usual; participants are unblinded to group allocation. Following site- and individual-level consent, participants complete a web-based baseline survey (time 0), including measures of work capacity, health and well-being, and health care resource use. Follow-up is performed at 3 months (time 1) and 6 months (time 2). Feasibility outcomes relate to recruitment; intervention fidelity (eg, delivery, reach, uptake, and engagement); retention; and follow-up. Qualitative evaluation (time 2) is mapped to the Capability, Opportunity, Motivation–Behavior model and will explore intervention acceptability to employees and employers, along with individual and contextual factors influencing the delivery and uptake of the intervention. Results: Ethics approval was obtained in March 2023. Trial recruitment began in June 2023. Conclusions: The PAW Toolkit is the first evidence-based digital health intervention aimed at supporting the self-management of chronic or persistent pain at work. This study will inform the design of a definitive trial, including sample size estimation, approaches to cluster site identification, primary and secondary outcomes’ selection, and the final health economic model. Findings will inform approaches for the future delivery of this digital health intervention. Trial Registration: ClinicalTrials.gov NCT05838677; https://clinicaltrials.gov/study/NCT05838677 International Registered Report Identifier (IRRID): DERR1-10.2196/51474 %M 37902814 %R 10.2196/51474 %U https://www.researchprotocols.org/2023/1/e51474 %U https://doi.org/10.2196/51474 %U http://www.ncbi.nlm.nih.gov/pubmed/37902814 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42164 %T Evaluation of Menstrual Cycle Tracking Behaviors in the Ovulation and Menstruation Health Pilot Study: Cross-Sectional Study %A Adnan,Tatheer %A Li,Huichu %A Peer,Komal %A Peebles,Elizabeth %A James,Kaitlyn %A Mahalingaiah,Shruthi %+ Massachusetts General Hospital, 677 Huntington Ave, Boston, MA, 02115, United States, 1 617 432 4381, shruthi@hsph.harvard.edu %K reproductive informatics %K menstrual health tracking apps %K digital epidemiology %K women's health %K mobile health %K mHealth %K gynecology %K health application %K tracking health app %K menstrual health %K reproductive health %D 2023 %7 27.10.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Menstrual cycle tracking apps (MCTAs) have potential in epidemiological studies of women’s health, facilitating real-time tracking of bleeding days and menstrual-associated signs and symptoms. However, information regarding the characteristics of MCTA users versus cycle nontrackers is limited, which may inform generalizability. Objective: We compared characteristics among individuals using MCTAs (app users), individuals who do not track their cycles (nontrackers), and those who used other forms of menstrual tracking (other trackers). Methods: The Ovulation and Menstruation Health Pilot Study tested the feasibility of a digitally enabled evaluation of menstrual health. Recruitment occurred between September 2017 and March 2018. Menstrual cycle tracking behavior, demographic, and general and reproductive health history data were collected from eligible individuals (females aged 18-45 years, comfortable communicating in English). Menstrual cycle tracking behavior was categorized in 3 ways: menstrual cycle tracking via app usage, that via other methods, and nontracking. Demographic factors, health conditions, and menstrual cycle characteristics were compared across the menstrual tracking method (app users vs nontrackers, app users vs other trackers, and other trackers vs nontrackers) were assessed using chi-square or Fisher exact tests. Results: In total, 263 participants met the eligibility criteria and completed the digital survey. Most of the cohort (n=191, 72.6%) was 18-29 years old, predominantly White (n=170, 64.6%), had attained 4 years of college education or higher (n= 209, 79.5%), and had a household income below US $50,000 (n=123, 46.8%). Among all participants, 103 (39%) were MCTA users (app users), 97 (37%) did not engage in any tracking (nontrackers), and 63 (24%) used other forms of tracking (other trackers). Across all groups, no meaningful differences existed in race and ethnicity, household income, and education level. The proportion of ever-use of hormonal contraceptives was lower (n=74, 71.8% vs n=87, 90%, P=.001), lifetime smoking status was lower (n=6, 6% vs n=15, 17%, P=.04), and diagnosis rate of gastrointestinal reflux disease (GERD) was higher (n=25, 24.3% vs n=12, 12.4%, P=.04) in app users than in nontrackers. The proportions of hormonal contraceptives ever used and lifetime smoking status were both lower (n=74, 71.8% vs n=56, 88.9%, P=.01; n=6, 6% vs n=11, 17.5%, P=.02) in app users than in other trackers. Other trackers had lower proportions of ever-use of hormonal contraceptives (n=130, 78.3% vs n=87, 89.7%, P=.02) and higher diagnostic rates of heartburn or GERD (n=39, 23.5% vs n=12, 12.4%, P.03) and anxiety or panic disorder (n=64, 38.6% vs n=25, 25.8%, P=.04) than nontrackers. Menstrual cycle characteristics did not differ across all groups. Conclusions: Our results suggest that app users, other trackers, and nontrackers are largely comparable in demographic and menstrual cycle characteristics. Future studies should determine reasons for tracking and tracking-related behaviors to further understand whether individuals who use MCTAs are comparable to nontrackers. %M 37889545 %R 10.2196/42164 %U https://www.jmir.org/2023/1/e42164 %U https://doi.org/10.2196/42164 %U http://www.ncbi.nlm.nih.gov/pubmed/37889545 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e48857 %T Varenicline Combined With Oral Nicotine Replacement Therapy and Smartphone-Based Medication Reminders for Smoking Cessation: Feasibility Randomized Controlled Trial %A Sifat,Munjireen %A Hébert,Emily T %A Ahluwalia,Jasjit S %A Businelle,Michael S %A Waring,Joseph J C %A Frank-Pearce,Summer G %A Bryer,Chase %A Benson,Lizbeth %A Madison,Stefani %A Planas,Lourdes G %A Baranskaya,Irina %A Kendzor,Darla E %+ Tobacco Settlement Endowment Trust Health Promotion Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, 655 Research Parkway, Suite 400, Oklahoma City, OK, 73104, United States, 1 215 955 8874, mys519@jefferson.edu %K mHealth %K smartphone-based medication reminders %K varenicline combined with oral nicotine replacement therapy %K smoking cessation %K medication adherence %K smoking %K smoker %K smoke %K cessation %K quit %K quitting %K nicotine %K nicotine replacement therapy %K NRT %K randomized %K controlled trial %K mobile phone %D 2023 %7 27.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Varenicline and oral nicotine replacement therapy (NRT) have each been shown to increase the likelihood of smoking cessation, but their combination has not been studied. In addition, smoking cessation medication adherence is often poor, thus, challenging the ability to evaluate medication efficacy. Objective: This study examined the effects of combined varenicline and oral NRT and smartphone medication reminders on pharmacotherapy adherence and smoking abstinence among adults enrolled in smoking cessation treatment. Methods: A 2×2 factorial design was used. Participants (N=34) were randomized to (1) varenicline + oral NRT (VAR+NRT) or varenicline alone (VAR) and (2) smartphone medication reminder messages (REM) or no reminder messages (NREM) over 13 weeks. Participants assigned to VAR+REM received varenicline reminder prompts, and those assigned to VAR+NRT+REM also received reminders to use oral NRT. The other 2 groups (VAR+NREM and VAR+NRT+NREM) did not receive medication reminders. Participants were not blinded to intervention groups. All participants received tobacco cessation counseling. Smartphone assessments of smoking as well as varenicline and NRT use (if applicable) were prompted daily through the first 12 weeks after a scheduled quit date. Descriptive statistics were generated to characterize the relations between medication and reminder group assignments with daily smoking, daily varenicline adherence, and daily quantity of oral NRT used. Participants completed follow-up assessments for 26 weeks after the quit date. Results: Participants were predominantly White (71%), and half were female (50%). On average, participants were 54.2 (SD 9.4) years of age, they smoked an average of 19.0 (SD 9.0) cigarettes per day and had smoked for 34.6 (SD 12.7) years. Descriptively, participants assigned to VAR+NRT reported more days of smoking abstinence compared to VAR (29.3 vs 26.3 days). Participants assigned to REM reported more days of smoking abstinence than those assigned to NREM (40.5 vs 21.8 days). Participants assigned to REM were adherent to varenicline on more days compared to those assigned to NREM (58.6 vs 40.5 days), and participants assigned to VAR were adherent to varenicline on more days than those assigned to VAR + NRT (50.7 vs 43.3 days). In the subsample of participants assigned to VAR+NRT, participants assigned to REM reported more days where ≥5 pieces of NRT were used than NREM (14.0 vs 7.4 days). Average overall medication adherence (assessed via the Medication Adherence Questionnaire) showed the same pattern as the daily smartphone-based adherence assessments. Conclusions: Preliminary findings indicated that smoking cessation interventions may benefit from incorporating medication reminders and combining varenicline with oral NRT, though combining medications may be associated with poorer adherence. Further study is warranted. Trial Registration: ClinicalTrials.gov NCT03722966; https://classic.clinicaltrials.gov/ct2/show/NCT03722966 %M 37889541 %R 10.2196/48857 %U https://formative.jmir.org/2023/1/e48857 %U https://doi.org/10.2196/48857 %U http://www.ncbi.nlm.nih.gov/pubmed/37889541 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e49962 %T Adolescents and Young Adults Evaluating a Website for Affective-Sexual Information and Education: Multicenter Cross-Sectional Study %A Montero-Pons,Laura %A Rodríguez-Martín,Dolors %A Esquinas,Cristina %A García-Sierra,Rosa %A Manresa-Domínguez,Josep Maria %A Reyes-Lacalle,Azahara %A Cabedo-Ferreiro,Rosa %A Vicente-Hernández,MªMercedes %A Gómez Masvidal,Míriam %A Toran-Monserrat,Pere %A Falguera-Puig,Gemma %+ Sexual and Reproductive Healthcare Santa Coloma de Gramenet, Primary Care Management Metropolitana Nord, Catalan Institute of Health, 49, 53 Major St, Santa Coloma de Gramenet, 08921, Spain, 34 936 932 736, lmontero.ics@gencat.cat %K sex education %K adolescent %K young adult %K internet %K cross-sectional studies %K program evaluation %K gender mainstreaming %D 2023 %7 26.10.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Today’s young people have long been demanding a paradigm shift in the emotional and sexual education they receive. While for them, affective-sexual and gender diversity is already a reality, the sexual and reproductive health professionals they encounter lack sufficient training. The digital devices and affective-sexual education websites aimed at today’s young people must also be thoroughly evaluated. The website Sexe Joves is a website on sexuality by the Department of Health of the Government of Catalonia (Spain). It is designed for people aged 14 to 25 years. It currently needs to undergo a process of evaluation. Affective-sexual education aimed at young people must stem from their participation and the whole range of sexual and gender diversity in order to reach the entire population equally. Objective: The aim of this study was to evaluate the website Sexe Joves as a source of affective-sexual health information, education, and communication for young people. It takes into account sex, gender identity, sexual orientation, socioeconomic status, and location within Catalonia (urban, semiurban, and rural areas). Methods: This was an observational, descriptive, and cross-sectional study that forms part of a larger mixed methods study. An ad hoc questionnaire was used to collect data. In total, 1830 participants were included. The study was carried out simultaneously in all the territorial administrations of Catalonia. Results: Almost 30% of the sample obtained were young people who experience affective-sexual and gender diversity. Of those surveyed, only 14.2% (n=260) said they were familiar with the website and of these, 6.5% said they used it (n=114). The website content rated most indispensable was on sexual abuse, harassment, and violence, followed by sexually transmitted infections; 70.5% (n=1200) reported that they visit pornographic websites. Conclusions: The results of this study will contribute to the design of new strategies for the website Sexe Joves, a public health resource, in order to improve affective sexual education for young people. International Registered Report Identifier (IRRID): RR2-10.3390/ijerph192416586 %M 37883153 %R 10.2196/49962 %U https://www.jmir.org/2023/1/e49962 %U https://doi.org/10.2196/49962 %U http://www.ncbi.nlm.nih.gov/pubmed/37883153 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 6 %N %P e49500 %T A Digital Tool for the Self-Assessment of Homes to Increase Age-Friendliness: Validity Study %A Aclan,Roslyn %A George,Stacey %A Laver,Kate %+ College of Medicine and Public Health, Flinders University of South Australia, Flinders Drive, Bedford Park, Adelaide, 5001, Australia, 61 0425730839, roslyn.dalistan@flinders.edu.au %K age-friendliness %K aging %K home environment %K self-assessment %K digital %K tool %D 2023 %7 26.10.2023 %9 Original Paper %J JMIR Aging %G English %X Background: Age-friendly environments in homes and communities play an important role in optimizing the health and well-being of society. Older people have strong preferences for remaining at home as they age. Home environment assessment tools that enable older people to assess their homes and prepare for aging in place may be beneficial. Objective: This study aims to establish the validity of a digital self-assessment tool by assessing it against the current gold standard, an occupational therapy home assessment. Methods: A cohort of adults aged ≥60 years living in metropolitan Adelaide, South Australia, Australia, assessed their homes using a digital self-assessment tool with 89 questions simultaneously with an occupational therapist. Adults who were living within their homes and did not have significant levels of disabilities were recruited. Cohen κ and Gwet AC1 were used to assess validity. Results: A total of 61 participants (age: mean 71.2, SD 7.03 years) self-assessed their own homes using the digital self-assessment tool. The overall levels of agreement were high, supporting the validity of the tool in identifying potential hazards. Lower levels of agreement were found in the following domains: steps (77% agreement, Gwet AC1=0.56), toilets (56% agreement, κ=0.10), bathrooms (64% agreement, κ=0.46), and backyards (55% agreement, κ=0.24). Conclusions: Older people were able to self-assess their homes using a digital self-assessment tool. Digital health tools enable older people to start thinking about their future housing needs. Innovative tools that can identify problems and generate solutions may improve the age-friendliness of the home environment. %M 37883134 %R 10.2196/49500 %U https://aging.jmir.org/2023/1/e49500 %U https://doi.org/10.2196/49500 %U http://www.ncbi.nlm.nih.gov/pubmed/37883134 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e49009 %T An Implementation Pilot of Web-Based Self-Training Programs on Sexual Dysfunctions in the Dutch Public Sexual Health Setting: Mixed Methods Study %A Zimbile,Filippo %A Beek,Titia %A David,Silke %A Crutzen,Rik %+ National Institute for Public Health and the Environment, Antonie van Leeuwenhoeklaan 9, Bilthoven, 3720BA, Netherlands, 31 0651953096, filippo.zimbile@rivm.nl %K implementation pilot digital health %K e-sexual health %K sexual dysfunctions %K self-care %K public health %K sexual issue %K barrier %K sexual health %K intervention %K young adult %K young %K sexual problem %D 2023 %7 26.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Web-based sexual health interventions may be more acceptable to people compared with face-to-face support, given the stigma and embarrassment often associated with sexual problems. The Dutch public sexual health clinics (SHCs) conducted an implementation pilot with 4 web-based self-training programs on sexual dysfunctions (WSTPs) for young people. In addition to a basic sexuality program, the WSTPs focused on the following complaints: pain during intercourse, premature ejaculation, and no sex drive. Objective: This study aims to gain insight into the potential reach of the freely offered WSTPs; use, acceptance, evaluation, and perceived impact of the WSTPs by young people; and evaluation and acceptance of the WSTPs by nurses of the SHCs. Methods: A quantitative baseline measurement (BM) and a follow-up measurement (FM) were conducted among the users. In addition, qualitative data were gathered through video interviews with a sample of respondents of the FM and nurses of the SHCs to gain more in-depth insights into their assessment of the WSTPs. Participants were recruited via social media, posters, and referrals by nurses of the SHCs. Quantitative data were analyzed using descriptive statistics. Independent 2-tailed t tests and one-way independent ANOVAs were used to compare the scores between subgroups based on background characteristics. Dependent 2-tailed t tests were used to assess the possible changes between BM and FM. The interviews were analyzed using a thematic analysis. Results: A total of 1028 young people (aged 16-24 y) completed the BM, 666 started with 1 of the WSTPs, and 104 participants completed the FM. In addition, 8 users and 8 nurses were interviewed. Of the participants who completed the BM, 87.74% (902/1028) experienced moderate (411/1028, 39.98%) to high (491/1028, 47.76%) severity of complaints, of which 20.43% (210/1028) had had them for >1 year and 27.82% (286/1028) even for ≥2 years, and 38.91% (400/1028) were dissatisfied with their sex lives. Only 8.75% (90/1028) had sought professional help in the past 2 years. At FM, users rated satisfaction with their sex life more positively than they did at BM, and they experienced less discomfort from their complaints. The overall rating was positive, with a mean report grade of 7.3 (SD 1.45; on a 10-point scale). Anonymity, clear information and explanation, and practical exercises are indicated as strengths of the WSTPs, leading to more understanding and normalization. Nurses appreciate the high quality of information and accessibility of the WSTPs. They consider them as a valuable addition to the consultation hours. Conclusions: WSTPs can reach a large number of young people with sexual problems who are less likely to seek professional help. This can result in an improved understanding of their issues, a decrease in complaints, and reduced barriers to communicating with a partner or professional. %M 37883172 %R 10.2196/49009 %U https://formative.jmir.org/2023/1/e49009 %U https://doi.org/10.2196/49009 %U http://www.ncbi.nlm.nih.gov/pubmed/37883172 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e50145 %T Digital Self-Monitoring Tools for the Management of Gestational Weight Gain: Protocol for a Systematic Review %A Mooney,Jan %A Dahl,Alicia A %+ Department of Public Health Sciences, College of Health and Human Services, University of North Carolina at Charlotte, 9201 University City Boulevard, Charlotte, NC, 28223, United States, 1 7046875612, adahl3@charlotte.edu %K protocol %K systematic review %K gestational weight gain %K self-monitoring %K digital health %K review methods %K review methodology %K pregnant %K pregnancy %K gestational %K weight %K maternal %K mobile phone %D 2023 %7 26.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Gestational weight gain (GWG) exceeding the recommendations of the Institute of Medicine (in the United States) is associated with numerous adverse maternal and infant health outcomes. While many behavioral interventions targeting nutrition and physical activity have been developed to promote GWG within the Institute of Medicine guidelines, engagement and results are variable. Technology-mediated interventions can potentially increase the feasibility, acceptability, and reach of interventions, particularly for pregnant women, for whom integration of interventions into daily life may be critical to retention and adherence. Previous reviews highlight GWG self-monitoring as a common intervention component, and emerging work has begun to integrate digital self-monitoring into technology-mediated interventions. With rapid advances in technology-mediated interventions, a focused synthesis of literature examining the role of digital self-monitoring tools in managing GWG is warranted to guide clinical practice and inform future studies. Objective: The proposed review aims to synthesize the emerging research base evaluating digital GWG self-monitoring interventions, primarily focusing on whether the intervention is effective in managing GWG. Depending on the characteristics of the included research, secondary focus areas will comprise intervention recruitment and retention, feasibility, acceptability, and differences between stand-alone and multicomponent interventions. Methods: This protocol was developed following the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) guidelines for systematic review protocols. The proposed review would use a planned and systematic approach to identify, evaluate, and synthesize relevant and recent empirical quantitative studies (reported in English) examining the use of digital weight self-monitoring tools in the context of technology-mediated interventions to manage GWG in pregnant US adults, with at least 2 instances of data collection. Literature eligible for inclusion will have a publication date between January 2010 and July 2020. The Effective Public Health Practice Project Quality Assessment Tool for Quantitative Studies will be used to assess the methodological quality of included studies across various domains, and results will be synthesized and summarized per the synthesis without meta-analysis guidelines. Results: The initial queries of 1150 records have been executed and papers have been screened for inclusion. Data extractions are expected to be finished by December 2023. Results are expected in 2024. The systematic review that will be generated from this protocol will offer evidence for the use of digital self-monitoring tools in the management of GWG. Conclusions: The planned, focused synthesis of relevant literature has the potential to inform the use of digital weight self-monitoring tools in the context of future technology-mediated interventions to manage GWG. In addition, the planned review has the potential to contribute as part of a broader movement in research toward empirically supporting the inclusion of specific components within more extensive, multicomponent interventions to balance parsimony and effectiveness. Trial Registration: PROSPERO CRD42020204820; https://tinyurl.com/ybzt6bvr International Registered Report Identifier (IRRID): PRR1-10.2196/50145 %M 37883145 %R 10.2196/50145 %U https://www.researchprotocols.org/2023/1/e50145 %U https://doi.org/10.2196/50145 %U http://www.ncbi.nlm.nih.gov/pubmed/37883145 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e47050 %T A Web-Based Total Worker Health Intervention for Those Fighting Wildland Fires: Mixed Methods Development and Effectiveness Trial %A Kuehl,Kerry %A Elliot,Diane %A DeFrancesco,Carol %A McGinnis,Wendy %A Ek,Susanna %A Garg,Bharti %+ Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR, 97239, United States, 1 503 575 6556, kuehlk@ohsu.edu %K wildland %K firefighter %K Total Worker Health %K web-based %K occupational safety %K health promotion %K wildland firefighter %K web-based safety %K mixed methods %K occupational health %K health and safety %K health care worker %K mobile phone %D 2023 %7 25.10.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Fire seasons are longer, with more and larger wildfires, placing increased demands and risks on those fighting wildland fires. There are multiple agencies involved with fighting wildland fires and unique worksite conditions make meeting these workers’ needs a challenge. Objective: The aim of the study is to develop and establish the effectiveness of a web-based safety and health program for those fighting wildland fires. Methods: This mixed methods project had 3 phases. The initial qualitative phase assessed the needs of 150 diverse firefighters through interviews and focus groups across 11 US sites to establish and prioritize program content. Interview transcripts were read for thematic content with iterative readings used to identify, code, and rank health and safety issues. The second phase used that information to build a comprehensive Total Worker Health program for those fighting wildfires. The program content was based on the qualitative interview data and consisted of 6 core and 8 elective 30-minute, web-based modules primarily done individually on a smartphone or computer. The final, third phase evaluated the program with a quantitative prospective proof-of-concept, usability, and effectiveness trial among wildland firefighter participants. Effectiveness was assessed with paired 2-tailed t tests for pre- and post-Likert agreement scale survey items, adjusted for multiple comparisons. In addition to assessing mean and SD at baseline and postsurvey, observed effect sizes were calculated (Cohen d). Usability and reaction to the program among firefighters who responded to postsurvey were also assessed. Results: The qualitative themes and subthemes were used to inform the program’s content. For the effectiveness trial, 131 firefighters completed the presurvey, and 50 (38.2%) completed the postsurvey. The majority of the participants were White (n=123, 93.9%), male (n=117, 89.3%), with an average age of 41 (SD 12.9) years. Significant increases in knowledge and desired health and safety behaviors were found for both cancer (P<.001) and cardiovascular risk (P=.01), nutrition behaviors (P=.01), hydration or overheating (P=.001), binge drinking (P=.002), and getting medical checkups (P=.001). More than 80% (n=40) of postsurvey respondents agreed or strongly agreed that the program was easy to use and would recommend it to others. Conclusions: An innovative web-based safety and health promotion program for those fighting wildland fires was feasible, scalable, and usable. It improved the health and safety of those fighting wildland fires. Trial Registration: ClinicalTrials.gov NCT05753358; https://classic.clinicaltrials.gov/ct2/show/NCT05753358 %M 37878362 %R 10.2196/47050 %U https://www.jmir.org/2023/1/e47050 %U https://doi.org/10.2196/47050 %U http://www.ncbi.nlm.nih.gov/pubmed/37878362 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e48912 %T Effect of Individual Virtual Reality Cognitive Training Programs on Cognitive Function and Depression in Middle-Aged Women: Randomized Controlled Trial %A Kim,Du-Ri %A Moon,EunSoo %A Shin,Myung-Jun %A Yang,Yeong-Ae %A Park,Jong-Hwan %+ Health Convergence Medicine Laboratory, Biomedical Research Institute, Pusan National University Hospital, 179, Gudeok-ro, Seo-gu, Busan, 49241, Republic of Korea, 82 0512407071, parkj@pusan.ac.kr %K cognitive function %K depression %K middle aged %K virtual reality %K women %D 2023 %7 25.10.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Given the increasing incidence of early-onset Alzheimer disease, strategies for early diagnosis and swift treatment interventions are crucial for mitigating cognitive problems in women and middle-aged individuals who face a high risk of cognitive impairment. Objective: This study aimed to assess the effectiveness of individual cognitive training programs based on virtual reality (VR), a nonpharmacological intervention, on cognitive function and depression in middle-aged women at risk of cognitive impairment. It used VR technology, which has recently been recognized as a promising tool. Methods: We administered a VR-based cognitive training program for 30 minutes daily, twice a week, for 12 weeks (24 sessions). This study included middle-aged women residing in older adults’ welfare facilities in G-gu, Busan, from May to August 2021. A total of 60 participants were randomly divided into the training (n=30) and control (n=30) groups. Cognitive and depressive functions were assessed using the Korean versions of the Montreal Cognitive Assessment (K-MoCA), Digit Span Test (DST), Korean-Color Word Stroop Test (K-CWST), and Short Form of the Geriatric Depression Scale (SGDS-K) before the intervention. The training group underwent a VR-based cognitive training program, whereas the control group was educated to maintain regular daily activities. The same assessments were performed 12 weeks after treatment. Results: A comparison of the mean scores before and after K-MoCA in the training group revealed a significant increase from 24.87 (SD 2.62) to 27.50 (SD 1.70; P<.01), indicating substantial cognitive improvement. Similarly, the mean DST forward scores increased significantly from 6.97 (SD 1.10) to 7.90 (SD 1.18; P<.01), suggesting enhanced short-term auditory memory and attention. The mean DST backward scores also showed a significant improvement from 4.10 (SD 0.71) to 4.77 (SD 1.2; P=.01). Notably, the mean SGDS-K scores decreased significantly from 3.97 (SD 2.51) to 2.13 (SD 1.87; P<.01), indicating a reduction in depression within the training group. Conclusions: The VR-based cognitive training programs significantly enhanced cognitive function and reduced depression in middle-aged women. Consequently, these programs are considered beneficial nonpharmacological cognitive training interventions for middle-aged women at high risk of cognitive impairment. Trial Registration: UMIN Clinical Trials Registry UMIN000049752; https://tinyurl.com/z5du989z %M 37878378 %R 10.2196/48912 %U https://mental.jmir.org/2023/1/e48912 %U https://doi.org/10.2196/48912 %U http://www.ncbi.nlm.nih.gov/pubmed/37878378 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46008 %T Web-Based Cognitive Bias Modification Program for Young People With Social Anxiety and Hazardous Alcohol Use: Feasibility, Acceptability, and Preliminary Efficacy Study %A Prior,Katrina %A Salemink,Elske %A Piggott,Monique %A Manning,Victoria %A Wiers,Reinout W %A Teachman,Bethany A %A Teesson,Maree %A Baillie,Andrew J %A Mahoney,Alison %A McLellan,Lauren %A Newton,Nicola C %A Stapinski,Lexine A %+ Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Level 6, Jane Foss Russell building (G02), Sydney, 2006, Australia, 61 286279032, katrina.prior@sydney.edu.au %K alcohol %K anxiety %K cognitive bias modification %K interpretation bias %K approach bias %K young adult %K mobile phone %D 2023 %7 25.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Interpretation bias modification (IBM) and approach bias modification (ApBM) cognitive retraining interventions can be efficacious adjunctive treatments for improving social anxiety and alcohol use problems. However, previous trials have not examined the combination of these interventions in a young, comorbid sample. Objective: This study aims to describe the feasibility, acceptability, and preliminary efficacy of a web-based IBM+ApBM program for young adults with social anxiety and hazardous alcohol use (“Re-Train Your Brain”) when delivered in conjunction with treatment as usual (TAU). Methods: The study involved a 3-arm randomized controlled pilot trial in which treatment-seeking young adults (aged 18-30 y) with co-occurring social anxiety and hazardous alcohol use were randomized to receive (1) the “integrated” Re-Train Your Brain program, where each session included both IBM and ApBM (50:50 ratio), plus TAU (35/100, 35%); (2) the “alternating” Re-Train Your Brain program, where each session focused on IBM or ApBM in an alternating pattern, plus TAU (32/100, 32%); or (3) TAU only (33/100, 33%). Primary outcomes included feasibility and acceptability, and secondary efficacy outcomes included changes in cognitive biases, social anxiety symptoms, and alcohol use. Assessments were conducted at baseline, after the intervention period (6 weeks after baseline), and 12 weeks after baseline. Results: Both Re-Train Your Brain program formats were feasible and acceptable for young adults. When coupled with TAU, both integrated and alternating programs resulted in greater self-reported improvements than TAU only in anxiety interpretation biases (at the 6-week follow-up; Cohen d=0.80 and Cohen d=0.89) and comorbid interpretation biases (at the 12-week follow-up; Cohen d=1.53 and Cohen d=1.67). In addition, the alternating group reported larger improvements over the control group in generalized social anxiety symptoms (at the 12-week follow-up; Cohen d=0.83) and alcohol cravings (at the 6-week follow-up; Cohen d=0.81). There were null effects on all other variables and no differences between the intervention groups in efficacy outcomes. Conclusions: Should these findings be replicated in a larger randomized controlled trial, Re-Train Your Brain has the potential to be a scalable, low-cost, and non–labor-intensive adjunct intervention for targeting interpretation and comorbidity biases as well as generalized anxiety and alcohol-related outcomes in the real world. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620001273976; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364131 International Registered Report Identifier (IRRID): RR2-10.2196/28667 %M 37878363 %R 10.2196/46008 %U https://formative.jmir.org/2023/1/e46008 %U https://doi.org/10.2196/46008 %U http://www.ncbi.nlm.nih.gov/pubmed/37878363 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e50860 %T A Mindfulness-Based Resiliency Program for Caregivers of Patients With Severe Acute Brain Injury Transitioning Out of Critical Care: Protocol for an Open Pilot Trial %A Presciutti,Alexander Mattia %A Woodworth,Emily %A Rochon,Elizabeth %A Neale,Molly %A Motta,Melissa %A Piazza,Joseph %A Vranceanu,Ana-Maria %A Hwang,David Yi-Gin %+ Department of Neurology, Division of Neurocritical Care, University of North Carolina School of Medicine, 170 Manning Drive, CB# 7025, Chapel Hill, NC, 27599, United States, 1 9199668178, david_hwang@med.unc.edu %K severe acute brain injury %K coma %K caregiver %K resilience %K mindfulness %K brain injury %K emotional distress %K decision-making %K emotional support %K intervention %K support %K self-report assessment %K mental health %D 2023 %7 25.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Caregivers of patients with severe acute brain injuries (SABI) that lead to coma and require intensive care unit (ICU) treatment often experience chronic emotional distress. To address this need, we developed the Coma Family (COMA-F) program, a mindfulness-based resiliency intervention for these caregivers. Objective: We will conduct an open pilot trial of COMA-F (National Institutes of Health Stage IA). Here we describe our study protocol and proposed intervention content. Methods: We will enroll 15 caregivers of patients with SABIs during their loved one’s hospital course from 3 enrollment centers. A clinical psychologist will deliver the COMA-F intervention (6 sessions) over Zoom (Zoom Video Communications, Inc) or in person. We will iterate COMA-F after each caregiver completes the intervention and an exit interview. English-speaking adults who have emotional distress confirmed by the clinical team and are the primary caregivers of a patient with SABI are eligible. The adult patient must have been admitted to the neuro-ICU for SABI and (1) have had a Glasgow Coma Scale score below 9 while not intubated or an inability to follow meaningful commands while intubated at any point during their hospitalization for >24 hours due to SABI; (2) will be undergoing either tracheostomy or percutaneous endoscopic or surgical gastrostomy tube placement or have already received one or both; and (3) have a prognosis of survival >3 months. We will identify eligible caregivers through screening patients’ medical records and through direct referrals from clinicians in the neuro-ICU. During the intervention we will teach caregivers mind-body and resilience skills, including deep breathing, mindfulness, meditation, dialectical thinking, acceptance, cognitive restructuring, effective communication, behavioral activation, and meaning-making. Caregivers will complete self-report assessments (measures of emotional distress and resilience) before and after the intervention. Primary outcomes are feasibility (recruitment, quantitative measures, adherence, and therapist fidelity) and acceptability (treatment satisfaction, credibility, and expectancy). We will conduct brief qualitative exit interviews to gather feedback on refining the program and study procedures. We will examine frequencies and proportions to determine feasibility and acceptability and will analyze qualitative exit interview data using thematic analysis. We will also conduct 2-tailed t tests to explore signals of improvement in emotional distress and treatment targets. We will then conduct an explanatory-sequential mixed methods analysis to integrate quantitative and qualitative data to refine the COMA-F manual and study procedures. Results: This study has been approved by the institutional review board at 1 of the 3 enrollment centers (2023P000536), with approvals at the other 2 centers pending. We anticipate that the study will be completed by late 2024. Conclusions: We will use our findings to refine the COMA-F intervention and prepare for a feasibility randomized controlled trial. Trial Registration: ClinicalTrials.gov NCT05761925; https://clinicaltrials.gov/study/NCT05761925 International Registered Report Identifier (IRRID): PRR1-10.2196/50860 %M 37878376 %R 10.2196/50860 %U https://www.researchprotocols.org/2023/1/e50860 %U https://doi.org/10.2196/50860 %U http://www.ncbi.nlm.nih.gov/pubmed/37878376 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e50105 %T Model Clinic to Increase Preventive Screenings Among Patients With Physical Disabilities: Protocol for a Mixed Methods Intervention Pilot Study %A Palazzolo,Beatrice %A Carbone,Loretta %A James,Tyler G %A Heizelman,Robert %A Sen,Ananda %A Mahmoudi,Elham %A McKee,Michael %+ Department of Family Medicine, University of Michigan, 1018 Fuller St, Ann Arbor, MI, 48104, United States, 1 734 998 7120, mmmckee@med.umich.edu %K clinical decision support %K electronic health records %K mixed methods %K people with physical disabilities %K primary care %D 2023 %7 25.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: People with physical disabilities often experience premature multimorbidity and adverse health events. A tailored primary care approach for this vulnerable population that also accounts for social and functional risk factors could promote healthier aging and more equitable health care. Objective: This project will evaluate the implementation of a health program designed for people with physical disabilities. The proposed evaluation result is to generate the first best-practice protocol focused specifically on developing primary care to help reduce preventable causes of morbidity and improve functioning among people with physical disabilities. Methods: We will design and implement a pilot health program for people with physical disabilities at a primary care clinic within Michigan Medicine. The health program for people with physical disabilities will be an integrated intervention involving a tailored best practice alert designed to prompt family medicine providers to screen and monitor for common, preventable health conditions. The program will also collect social and functional status information to determine the patient’s need for further care coordination and support. Adult participants from this clinic with identified physical disabilities will be targeted for potential enrollment. To create a quasi-experimental setting, a separate departmental clinic will serve as a control site for comparison purposes. A quantitative analysis to estimate the treatment effect of implementing this health program will be conducted using a difference-in-differences approach. Outcomes of interest will include the use of preventative services (eg, hemoglobin A1c for diabetes screening), social work assistance, and emergency and hospital services. These data will be extracted from electronic health records. Time-invariant covariates, particularly sociodemographic covariates, will be included in the models. A qualitative analysis of patient and health care provider interviews will also be completed to assess the effect of the health program. Patient Health Questionnaire-9 and Generalized Anxiety Disorder 7-item scores will be assessed to both screen for depression and anxiety as well as explore program impacts related to addressing health and functioning needs related to physical disabilities in a primary care setting. These will be summarized through descriptive analyses. Results: This study was funded in September 2018, data collection started in September 2021, and data collection is expected to be concluded in September 2023. Conclusions: This study is a mixed methods evaluation of the effectiveness of an integrated health program designed for people with physical disabilities, based on a quasi-experimental comparison between an intervention and a control clinic site. The intervention will be considered successful if it leads to improvements in greater use of screening and monitoring for preventable health conditions, increased social worker referrals to assist with health and functioning needs, and improvements in emergency and hospital-based services. The findings will help inform best practices for people with physical disabilities in a primary care setting. International Registered Report Identifier (IRRID): DERR1-10.2196/50105 %M 37878375 %R 10.2196/50105 %U https://www.researchprotocols.org/2023/1/e50105 %U https://doi.org/10.2196/50105 %U http://www.ncbi.nlm.nih.gov/pubmed/37878375 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46651 %T Improving Mild to Moderate Depression With an App-Based Self-Guided Intervention: Protocol for a Randomized Controlled Trial %A Beintner,Ina %A Kerber,André %A Dominke,Clara %A Voderholzer,Ulrich %+ MindDoc Health GmbH, Leopoldstraße 159, Munich, 80804, Germany, 49 015128346250, ibeintner@minddoc.de %K depression %K mobile app %K intervention %K unguided %K transdiagnostic %K randomized controlled trial %K e-mental health %K digital app %K self-management %K mental health %K mHealth %K mobile health %K unguided digital intervention %K public health %K digital intervention %K mobile phone %D 2023 %7 25.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Depression is one of the most prevalent mental disorders and frequently co-occurs with other mental disorders. Despite the high direct and indirect costs to both individuals and society, more than 80% of those diagnosed with depression remain with their primary care physician and do not receive specialized treatment. Self-guided digital interventions have been shown to improve depression and, due to their scalability, have a large potential public health impact. Current digital interventions often focus on specific disorders, while recent research suggests that transdiagnostic approaches are more suitable. Objective: This paper presents the protocol for a study that aims to assess the efficacy of a self-guided transdiagnostic app-based self-management intervention in patients with mild or moderate depression with and without comorbid mental disorders. Specifically, we are investigating the impact of the intervention on symptoms of depression, quality of life, anxiety symptoms, and mental health–related patient empowerment and self-management skills. Methods: The intervention under investigation, MindDoc with Prescription, is a self-guided digital intervention aimed at supporting individuals with mild to moderate mental disorders from the internalizing spectrum, including depression. The app can be used as a low-threshold psychosocial intervention. Up to 570 adult patients will be randomized to either receive the intervention in addition to care as usual or only care as usual. We are including adults with a permanent residency in Germany and mild or moderate depression according to International Classification of Diseases, 10th Revision, criteria (F32.0, F32.1, F33.0, and F33.1). Clinical interviews will be conducted to confirm the diagnosis. Data will be collected at baseline as well as 8 weeks and 6 months after randomization. The primary outcome will be depression symptom severity after 8 weeks. Secondary outcomes will be quality of life, anxiety symptom severity, and patient empowerment and self-management behaviors. Data will be analyzed using multiple imputations, using the intention-to-treat principle, while sensitivity analyses will be based on additional imputation strategies and a per-protocol analysis. Results: Recruitment for the trial started on February 7, 2023, and the first participant was randomized on February 14, 2023. As of September 5, 2023, 275 participants have been included in the trial and 176 have provided the primary outcome. The rate of missing values in the primary outcome is approximately 20%. Conclusions: Data from this efficacy trial will be used to establish whether access to the intervention is associated with an improvement in depression symptoms in individuals diagnosed with mild or moderate depression. The study will contribute to expanding the evidence base on transdiagnostic digital interventions. Trial Registration: German Registry of Clinical Trials DRKS00030852; https://drks.de/search/de/trial/DRKS00030852 International Registered Report Identifier (IRRID): DERR1-10.2196/46651 %M 37878374 %R 10.2196/46651 %U https://www.researchprotocols.org/2023/1/e46651 %U https://doi.org/10.2196/46651 %U http://www.ncbi.nlm.nih.gov/pubmed/37878374 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44764 %T Challenges With the Use of Digital Sham: Systematic Review and Recommendations %A Bos,Ernst %A Preller,Katrin H %A Kaur,Gavneet %A Malhotra,Pooja %A Kharawala,Saifuddin %A Motti,Dario %+ F Hoffmann-La Roche Ltd, Bldg 1/Floor 27, Grenzacherstrasse 124, Basel, 4070, Switzerland, 41 79 88 27 435, dario.motti@roche.com %K cognitive behavioral therapy %K digital intervention %K sham %K neurosciences %K neurodegenerative diseases %K placebo %K psychiatric disorders %K systematic review %K mobile phone %D 2023 %7 24.10.2023 %9 Review %J J Med Internet Res %G English %X Background: Digital therapeutics (DTx) are software-based products that prevent, manage, or treat a medical condition and are delivered through a smartphone app, web application, or wearable device. Clinical trials assessing DTx pose challenges, foremost among which is designing appropriate digital shams (or digital placebos), which should ideally mimic DTx (in terms of design, components, and duration of treatment) while omitting the active principle or component. Objective: The objective of our review was to understand how digital shams are being used in clinical research on DTx in neuroscience, which is the most common therapy area for DTx. Methods: We conducted a systematic literature review of DTx in neuroscience (including neurodevelopmental, neurodegenerative, and psychiatric disorders) with a focus on controlled clinical trials involving digital shams. Studies were identified from trial registries (ClinicalTrials.gov, the European Union Clinical Trials Register, and Trial Trove) and through structured searches in MEDLINE and Embase (both via the Embase website) and were limited to articles in English published from 2010 onward. These were supplemented by keyword-based searches in PubMed, Google, and Google Scholar and bibliographic searches. Studies assessing DTx in neuroscience (including neurodevelopmental, neurodegenerative, and psychiatric disorders) were included. Details related to the publication, DTx, comparator, patient population, and outcomes were extracted and analyzed. Results: Our search criteria identified 461 neuroscience studies involving 213 unique DTx. Most DTx were extended reality based (86/213, 40.4%) or mobile device based (56/213, 26.3%); 313 were comparative, of which 68 (21.7%) used shams. The most common therapeutic areas assessed in these studies were stroke (42/213, 19.7%), depression (32/213, 15%), and anxiety (24/213, 11.3%). The most common treatments were cognitive behavioral therapy or behavioral therapy (67/213, 32.4%), physical rehabilitation (60/213, 28.2%), and cognitive training (41/213, 19.2%). We identified the following important issues related to the use of digital shams in neuroscience: shams were not validated before use in studies, they varied widely in design (from being nearly identical to the DTx to using different software programs altogether), and the level of patient engagement or satisfaction with the sham and the impact of the sham on study outcomes were infrequently reported. Conclusions: Digital shams are critical for the clinical development of DTx in neuroscience. Given the importance of sham controls in evaluating DTx efficacy, we provide recommendations on the key information that should be reported in a well-designed DTx trial and propose an algorithm to allow the correct interpretation of DTx study results. Sham-controlled studies should be routinely used in DTx trials—in early-phase studies—to help identify DTx active components and—in late-phase studies—to confirm the efficacy of DTx. The use of shams early in development will ensure that the appropriate sham control is used in later confirmatory trials. %M 37874638 %R 10.2196/44764 %U https://www.jmir.org/2023/1/e44764 %U https://doi.org/10.2196/44764 %U http://www.ncbi.nlm.nih.gov/pubmed/37874638 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e49783 %T Comparing the Acceptability and Quality of Intervention Modalities for Suicidality in the Emergency Department: Randomized Feasibility Trial %A Larkin,Celine %A Tulu,Bengisu %A Djamasbi,Soussan %A Garner,Roscoe %A Varzgani,Fatima %A Siddique,Mariam %A Pietro,John %A Boudreaux,Edwin D %+ Department of Emergency Medicine, University of Massachusetts Chan Medical School, 55 Lake Avenue North, Worcester, MA, 01655, United States, 1 5084211436, celine.larkin@umassmed.edu %K suicide %K self-harm %K emergency department %K mobile app %K intervention %K mobile technology %K safety planning %K safety %K suicidal %K emergency %K mHealth %K mobile health %K mental health %K mobile phone %D 2023 %7 24.10.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Emergency departments (EDs) manage many patients with suicide risk, but effective interventions for suicidality are challenging to implement in this setting. ReachCare is a technology-facilitated version of an evidence-based intervention for suicidal ED patients. Here, we present findings on the acceptability and quality of ReachCare in the ED, as well as a comparison of these measures across 3 potential delivery modalities Objective: Our aim was to test the feasibility of the ReachCare intervention in its entirety through conducting a pilot study with patients presenting with suicidality to the ED. We tested three different ways of receiving the ED-based components of ReachCare: (1) self-administered on the tablet app using a chatbot interface, (2) administered by an in-person clinician, or (3) administered by a telehealth clinician. Methods: In total, 47 ED patients who screened positive for suicide risk were randomly allocated to receive one of three delivery modalities of ReachCare in the ED: (1) self-administered on the patient-facing tablet app with a chatbot interface, (2) delivered by an in-person clinician, or (3) delivered by a telehealth clinician, with the latter two using a clinician-facing web app. We measured demographic and clinical characteristics, acceptability and appropriateness of the intervention, and quality and completeness of the resulting safety plans. Results: Patients assigned high ratings for the acceptability (median 4.00/5, IQR 4.00-4.50) and appropriateness (median 4.00/5, IQR 4.00-4.25) of ReachCare’s ED components, and there were no substantial differences across the 3 delivery modalities [H(acceptability)=3.90, P=.14; H(appropriateness)=1.05, P=.59]. The self-administered modality took significantly less time than the 2 clinician modalities (H=27.91, P<.001), and the usability of the self-administered version was in the “very high” range (median 93.75/100, IQR 80.00-97.50). The safety plans created across all 3 modalities were high-quality (H=0.60, P=.74). Conclusions: Patients rated ReachCare in the ED as highly acceptable and appropriate regardless of modality. Self-administration may be a feasible way to ensure patients with suicide risk receive an intervention in resource constrained EDs. Limitations include small sample size and demographic differences between those enrolled versus not enrolled. Further research will examine the clinical outcomes of patients receiving both the in-ED and post-ED components of ReachCare. Trial Registration: ClinicalTrials.gov NCT04720911; https://clinicaltrials.gov/ct2/show/NCT04720911 %M 37874619 %R 10.2196/49783 %U https://mental.jmir.org/2023/1/e49783 %U https://doi.org/10.2196/49783 %U http://www.ncbi.nlm.nih.gov/pubmed/37874619 %0 Journal Article %@ 2817-092X %I JMIR Publications %V 2 %N %P e47881 %T The Easy and Versatile Neural Recording Platform (T-REX): Design and Development Study %A Amigó-Vega,Joaquín %A Ottenhoff,Maarten C %A Verwoert,Maxime %A Kubben,Pieter %A Herff,Christian %+ Computer Science Department, Gran Sasso Science Institute, Viale Francesco Crispi, 7, L'Aquila, 67100, Italy, 39 0862 4280 001, joaquin.amigo@gssi.it %K recording %K platform %K flexible %K data recording %K neurotechnology %K experiments %D 2023 %7 24.10.2023 %9 Original Paper %J JMIR Neurotech %G English %X Background: Recording time in invasive neuroscientific research is limited and must be used as efficiently as possible. Time is often lost due to a long setup time and errors by the researcher, driven by the number of manually performed steps. Currently, recording solutions that automate experimental overhead are either custom-made by researchers or provided as a submodule in comprehensive neuroscientific toolboxes, and there are no platforms focused explicitly on recording. Objective: Minimizing the number of manual actions may reduce error rates and experimental overhead. However, automation should avoid reducing the flexibility of the system. Therefore, we developed a software package named T-REX (Standalone Recorder of Experiments) that specifically simplifies the recording of experiments while focusing on retaining flexibility. Methods: The proposed solution is a standalone webpage that the researcher can provide without an active internet connection. It is built using Bootstrap5 for the frontend and the Python package Flask for the backend. Only Python 3.7+ and a few dependencies are required to start the different experiments. Data synchronization is implemented using Lab Streaming Layer, an open-source networked synchronization ecosystem, enabling all major programming languages and toolboxes to be used for developing and executing the experiments. Additionally, T-REX runs on Windows, Linux, and macOS. Results: The system reduces experimental overhead during recordings to a minimum. Multiple experiments are centralized in a simple local web interface that reduces an experiment’s setup, start, and stop to a single button press. In principle, any type of experiment, regardless of the scientific field (eg, behavioral or cognitive sciences, and electrophysiology), can be executed with the platform. T-REX includes an easy-to-use interface that can be adjusted to specific recording modalities, amplifiers, and participants. Because of the automated setup, easy recording, and easy-to-use interface, participants may even start and stop experiments by themselves, thus potentially providing data without the researcher’s presence. Conclusions: We developed a new recording platform that is operating system independent, user friendly, and robust. We provide researchers with a solution that can greatly increase the time spent on recording instead of setting up (with its possible errors). %R 10.2196/47881 %U https://neuro.jmir.org/2023/1/e47881 %U https://doi.org/10.2196/47881 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e48245 %T Preliminary Clinical Outcomes of the Hello Sunday Morning Alcohol and Wellbeing Self-Assessment: Feasibility and Acceptability Study %A Fletcher,Kathryn %A Moran-Pryor,Alex %A Robert-Hendren,Dominique %+ Hello Sunday Morning, 103 Alexander Street Crows Nest NSW, Sydney, 2065, Australia, 61 1300 403 196, kat.fletcher@hellosundaymorning.org %K web-based %K screening %K alcohol use %K brief intervention %K well-being %K psychological distress %K digital health %D 2023 %7 24.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Alcohol-related injuries and diseases are a leading cause of morbidity and mortality worldwide. Early intervention is essential given the chronic, relapsing nature of alcohol use disorders. There is significant potential for widely accessible web-based screening tools to help individuals determine where they stand in terms of alcohol use and provide support recommendations. Screening and brief interventions (SBIs) provide individuals with a stigma-free opportunity to learn and think about the potential risks of drinking and prompt help-seeking behavior by incorporating behavior change techniques. Furthermore, as excessive alcohol use and mental health problems often occur concurrently, SBIs for both conditions simultaneously can potentially address a critical gap in alcohol and mental health treatment. Objective: We investigated the feasibility, acceptability, and clinical outcomes of participants completing the Alcohol and Wellbeing Self-assessment (A&WS), a web-based SBI. Methods: The A&WS is freely available on the Hello Sunday Morning website as part of an uncontrolled observational prospective study. Feasibility was assessed based on the number of respondents who commenced and subsequently completed the A&WS. Acceptability was measured via participant feedback to determine overall satisfaction, perceived helpfulness, and likelihood of recommending the A&WS to others. Clinical outcomes were measured in two ways: (1) self-reported changes in alcohol consumption (Alcohol Use Disorders Identification Test score) or psychological distress (Kessler Psychological Distress Scale score) over time and (2) help seeking—both self-reported and immediate web-based help seeking. Preliminary baseline data collected for the first 9 months (March 2022 to December 2022) of the study were reported, including the 3-month follow-up outcomes. Results: A total of 17,628 participants commenced the A&WS, and of these, 14,419 (81.8%) completed it. Of those 14,419 who completed the A&WS, 1323 (9.18%) agreed to participate in the follow-up research. Acceptability was high, with 78.46% (1038/1323) reporting high satisfaction levels overall; 95.62% (1265/1323) found the A&WS easy to use and would recommend the tool to others. The 1-, 2-, and 3-month follow-ups were completed by 28.57% (378/1323), 21.09% (279/1323), and 17.61% (233/1323) of the participants, respectively. Significant reductions in the Alcohol Use Disorders Identification Test Consumption subscale (P<.001) and Kessler Psychological Distress Scale scores (P<.001) were observed over the 3-month follow-up period. Conclusions: Our results suggest that the A&WS is a highly feasible and acceptable digital SBI that may support individuals in making changes to their alcohol consumption and improve their psychological well-being. In the absence of a control group, positive clinical outcomes cannot be attributed to the A&WS, which should now be subjected to a randomized controlled trial. This scalable, freely available tool has the potential to reach a large number of adults who might not otherwise access help while complementing the alcohol and mental health treatment ecosystem. %M 37874615 %R 10.2196/48245 %U https://formative.jmir.org/2023/1/e48245 %U https://doi.org/10.2196/48245 %U http://www.ncbi.nlm.nih.gov/pubmed/37874615 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47813 %T Identifying Design Opportunities for Adaptive mHealth Interventions That Target General Well-Being: Interview Study With Informal Care Partners %A Yan,Xinghui %A Newman,Mark W %A Park,Sun Young %A Sander,Angelle %A Choi,Sung Won %A Miner,Jennifer %A Wu,Zhenke %A Carlozzi,Noelle %+ Department of Physical Medicine and Rehabilitation, University of Michigan, North Campus Research Complex 2800 Plymouth Rd., Building NCRC B14, Ann Arbor, MI, 48108, United States, 1 734 764 0644, carlozzi@umich.edu %K mHealth intervention %K mobile health %K behavior change %K qualitative study %K user adherence %K behavioral messages %K general well-being %D 2023 %7 24.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Mobile health (mHealth) interventions can deliver personalized behavioral support to users in daily contexts. These interventions have been increasingly adopted to support individuals who require low-cost and low-burden support. Prior research has demonstrated the feasibility and acceptability of an mHealth intervention app (CareQOL) designed for use with informal care partners. To further optimize the intervention delivery, we need to investigate how care partners, many of whom lack the time for self-care, react and act in response to different behavioral messages. Objective: The goal of this study was to understand the factors that impact care partners’ decision-making and actions in response to different behavioral messages. Insights from this study will help optimize future tailored and personalized behavioral interventions. Methods: We conducted semistructured interviews with participants who had recently completed a 3-month randomized controlled feasibility trial of the CareQOL mHealth intervention app. Of the 36 participants from the treatment group of the randomized controlled trial, 23 (64%) participated in these interviews. To prepare for each interview, the team first selected representative behavioral messages (eg, targeting different health dimensions) and presented them to participants during the interview to probe their influence on participants’ thoughts and actions. The time of delivery, self-reported perceptions of the day, and user ratings of a message were presented to the participants during the interviews to assist with recall. Results: The interview data showed that after receiving a message, participants took various actions in response to different messages. Participants performed suggested behaviors or adjusted them either immediately or in a delayed manner (eg, sometimes up to a month later). We identified 4 factors that shape the variations in user actions in response to different behavioral messages: uncertainties about the workload required to perform suggested behaviors, concerns about one’s ability to routinize suggested behaviors, in-the-moment willingness and ability to plan for suggested behaviors, and overall capability to engage with the intervention. Conclusions: Our study showed that care partners use mHealth behavioral messages differently regarding the immediacy of actions and the adaptation to suggested behaviors. Multiple factors influence people’s perceptions and decisions regarding when and how to take actions. Future systems should consider these factors to tailor behavioral support for individuals and design system features to support the delay or adaptation of the suggested behaviors. The findings also suggest extending the assessment of user adherence by considering the variations in user actions on behavioral support (ie, performing suggested or adjusted behaviors immediately or in a delayed manner). International Registered Report Identifier (IRRID): RR2-10.2196/32842 %M 37874621 %R 10.2196/47813 %U https://formative.jmir.org/2023/1/e47813 %U https://doi.org/10.2196/47813 %U http://www.ncbi.nlm.nih.gov/pubmed/37874621 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48758 %T Digital Training Program for Line Managers (Managing Minds at Work): Protocol for a Feasibility Pilot Cluster Randomized Controlled Trial %A Thomson,Louise %A Hassard,Juliet %A Frost,Alexandra %A Bartle,Craig %A Yarker,Joanna %A Munir,Fehmidah %A Kneller,Richard %A Marwaha,Steven %A Daly,Guy %A Russell,Sean %A Meyer,Caroline %A Vaughan,Benjamin %A Newman,Kristina %A Blake,Holly %+ School of Medicine, University of Nottingham, Yang Fujia Building, Jubilee Campus, Wollaton Road, Nottingham, NG8 1BB, United Kingdom, 44 1157484314, louise.thomson@nottingham.ac.uk %K acceptability %K anxiety %K burnout %K cluster randomised control trial %K depression %K digital training %K feasibility %K intervention %K intervention %K managers %K mental health %K stress %K usability %K work %K workplace %D 2023 %7 24.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Mental health problems affect 1 in 6 workers annually and are one of the leading causes of sickness absence, with stress, anxiety, and depression being responsible for half of all working days lost in the United Kingdom. Primary interventions with a preventative focus are widely acknowledged as the priority for workplace mental health interventions. Line managers hold a primary role in preventing poor mental health within the workplace and, therefore, need to be equipped with the skills and knowledge to effectively carry out this role. However, most previous intervention studies have directly focused on increasing line managers’ understanding and awareness of mental health rather than giving them the skills and competencies to take a proactive preventative approach in how they manage and design work. The Managing Minds at Work (MMW) digital training intervention was collaboratively designed to address this gap. The intervention aims to increase line managers’ knowledge and confidence in preventing work-related stress and promoting mental health at work. It consists of 5 modules providing evidence-based interactive content on looking after your mental health, designing and managing work to promote mental well-being, management competencies that prevent work-related stress, developing a psychologically safe workplace, and having conversations about mental health at work. Objective: The primary aim of this study is to pilot and feasibility test MMW, a digital training intervention for line managers. Methods: We use a cluster randomized controlled trial design consisting of 2 arms, the intervention arm and a 3-month waitlist control, in this multicenter feasibility pilot study. Line managers in the intervention arm will complete a baseline questionnaire at screening, immediately post intervention (approximately 6 weeks after baseline), and at 3- and 6-month follow-ups. Line managers in the control arm will complete an initial baseline questionnaire, repeated after 3 months on the waitlist. They will then be granted access to the MMW intervention, following which they will complete the questionnaire post intervention. The direct reports of the line managers in both arms of the trial will also be invited to take part by completing questionnaires at baseline and follow-up. As a feasibility pilot study, a formal sample size is not required. A minimum of 8 clusters (randomized into 2 groups of 4) will be sought to inform a future trial from work organizations of different types and sectors. Results: Recruitment for the study closed in January 2022. Overall, 24 organizations and 224 line managers have been recruited. Data analysis was finished in August 2023. Conclusions: The results from this feasibility study will provide insight into the usability and acceptability of the MMW intervention and its potential for improving line manager outcomes and those of their direct reports. These results will inform the development of subsequent trials. Trial Registration: ClinicalTrials.gov NCT05154019; https://clinicaltrials.gov/study/NCT05154019 International Registered Report Identifier (IRRID): DERR1-10.2196/48758 %M 37874612 %R 10.2196/48758 %U https://www.researchprotocols.org/2023/1/e48758 %U https://doi.org/10.2196/48758 %U http://www.ncbi.nlm.nih.gov/pubmed/37874612 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47151 %T A Trauma-Informed, Geospatially Aware, Just-in-Time Adaptive mHealth Intervention to Support Effective Coping Skills Among People Living With HIV in New Orleans: Development and Protocol for a Pilot Randomized Controlled Trial %A Skeen,Simone J %A Tokarz,Stephanie %A Gasik,Rayna E %A Solano,Chelsea McGettigan %A Smith,Ethan A %A Sagoe,Momi Binaifer %A Hudson,Lauryn V %A Steele,Kara %A Theall,Katherine P %A Clum,Gretchen A %+ Department of Social, Behavioral, and Population Sciences, School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, 22nd Fl, New Orleans, LA, 70112, United States, 1 504 988 1847, sskeen@tulane.edu %K mobile health %K mHealth %K HIV %K traumatic stress %K posttraumatic growth %K coping %K geospatial %K just-in-time adaptive intervention %K JITAI %K just-in-time %K posttraumatic %K medication adherence %K mental well-being %K viral suppression %K coping %K development %K design %K acceptability %K feasibility %K mobile phone %D 2023 %7 24.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: In 2020, Greater New Orleans, Louisiana, was home to 7048 people living with HIV—1083 per 100,000 residents, 2.85 times the US national rate. With Louisiana routinely ranked last in indexes of health equity, violent crime rates in Orleans Parish quintupling national averages, and in-care New Orleans people living with HIV surviving twice the US average of adverse childhood experiences, accessible, trauma-focused, evidence-based interventions (EBIs) for violence-affected people living with HIV are urgently needed. Objective: To meet this need, we adapted Living in the Face of Trauma, a well-established EBI tailored for people living with HIV, into NOLA GEM, a just-in-time adaptive mobile health (mHealth) intervention. This study aimed to culturally tailor and refine the NOLA GEM app and assess its acceptability; feasibility; and preliminary efficacy on care engagement, medication adherence, viral suppression, and mental well-being among in-care people living with HIV in Greater New Orleans. Methods: The development of NOLA GEM entailed identifying real-time tailoring variables via a geographic ecological momentary assessment (GEMA) study (n=49; aim 1) and place-based and user-centered tailoring, responsive to the unique cultural contexts of HIV survivorship in New Orleans, via formative interviews (n=12; aim 2). The iOS- and Android-enabled NOLA GEM app leverages twice-daily GEMA prompts to offer just-in-time, in-app recommendations for effective coping skills practice and app-delivered Living in the Face of Trauma session content. For aim 3, the pilot trial will enroll an analytic sample of 60 New Orleans people living with HIV individually randomized to parallel NOLA GEM (intervention) or GEMA-alone (control) arms at a 1:1 allocation for a 21-day period. Acceptability and feasibility will be assessed via enrollment, attrition, active daily use through paradata metrics, and prevalidated usability measures. At the postassessment time point, primary end points will be assessed via a range of well-validated, domain-specific scales. Care engagement and viral suppression will be assessed via past missed appointments and self-reported viral load at 30 and 90 days, respectively, and through well-demonstrated adherence self-efficacy measures. Results: Aims 1 and 2 have been achieved, NOLA GEM is in Beta, and all aim-3 methods have been reviewed and approved by the institutional review board of Tulane University. Recruitment was launched in July 2023, with a target date for follow-up assessment completion in December 2023. Conclusions: By leveraging user-centered development and embracing principles that elevate the lived expertise of New Orleans people living with HIV, mHealth-adapted EBIs can reflect community wisdom on posttraumatic resilience. Sustainable adoption of the NOLA GEM app and a promising early efficacy profile will support the feasibility of a future fully powered clinical trial and potential translation to new underserved settings in service of holistic survivorship and well-being of people living with HIV. Trial Registration: ClinicalTrials.gov NCT05784714; https://clinicaltrials.gov/ct2/show/NCT05784714 International Registered Report Identifier (IRRID): PRR1-10.2196/47151 %M 37874637 %R 10.2196/47151 %U https://www.researchprotocols.org/2023/1/e47151 %U https://doi.org/10.2196/47151 %U http://www.ncbi.nlm.nih.gov/pubmed/37874637 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e48968 %T Effectiveness of a Theory-Based Digital Animated Video Intervention to Reduce Intention and Willingness to Sext Among Diploma Students: Cluster Randomized Controlled Trial %A Mansor,Norain %A Ahmad,Norliza %A Md Said,Salmiah %A Tan,Kit-Aun %A Sutan,Rosnah %+ Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, UPM Serdang, Serdang, 43400, Malaysia, 60 192710577, lizaahmad@upm.edu.my %K sexting %K randomized controlled trial %K YouTube %K intention %K willingness %K young adult %K Malaysia, diploma students %K digital content %K digital health intervention %K attrition rate %K primary outcome %K sexual risk %K sexual health %K WhatsApp %D 2023 %7 20.10.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Sexting refers to the exchange of sexually explicit digital content in the form of texts, photos, or videos. In recent years, sexting has become a public health concern. Surveys in Malaysia show a high prevalence of young adults engaged in sexting. Given that sexting is associated with sexual risk behavior, cyberbullying, and mental health issues, this behavior needs intervention to alleviate the resulting public health burden. However, there is a scarcity of theory-based intervention programs on the prevention of intention and willingness to sext among young adults. Objective: This study aimed to develop and implement a sexting intervention module guided by the prototype willingness model (PWM), delivered using web-based animated video, and evaluate its effectiveness among diploma students from a public higher educational institution. The primary outcomes were intention and willingness to sext, while the secondary outcomes were knowledge, attitude, perceived norms, and prototype perceptions of sexting. Methods: This 2-armed, parallel, single-blinded cluster randomized controlled trial was conducted in a public higher educational institution in the state of Melaka, Malaysia. Diploma students from 12 programs were randomly allocated into intervention and control groups. Both groups answered a self-administered web-based questionnaire assessing the outcomes at the baseline. The intervention group received a newly developed intervention module based on the PWM in the form of 5 animated videos posted on a private YouTube platform, while the control group was put on the waitlist. The intervention group was encouraged to discuss any issues raised with the researchers via WhatsApp private chat after viewing the videos. All participants were observed immediately and 3 months postintervention. Data analysis was performed with SPSS (version 26; IBM Corp). A generalized linear mixed model was used to determine the effectiveness of the intervention. Results: There were a total of 300 participants with an attrition rate of 8.3% (n=25). After adjusting for age, sex, relationship status, and the amount of time spent on the web, there were significant differences in the intention to sext (β=–.12; P=.002; Cohen d=0.23), willingness to sext (β=–.16; P<.001; Cohen d=0.40), knowledge (β=.12; P<.001; Cohen d=0.39), attitude (β=–.11; P=.001; Cohen d=0.31), perceived norms (β=–.06; P=.04; Cohen d=0.18), and prototype perceptions (β=–.11; P<.001; Cohen d=0.35) between the intervention and control groups over 3 months. Conclusions: In this study, the sexting intervention module using the PWM that was delivered via web-based animated videos was effective in reducing intention and willingness to sext as well as in improving knowledge of sexting, attitudes, perceived norms, and prototype perceptions. Therefore, relevant agencies involved in the promotion of sexual and reproductive health among young adults in Malaysia can consider the implementation of this module. Trial Registration: Thai Clinical Trial Registry TCTR20201010002; https://www.thaiclinicaltrials.org/show/TCTR20201002001 %M 37862090 %R 10.2196/48968 %U https://www.jmir.org/2023/1/e48968 %U https://doi.org/10.2196/48968 %U http://www.ncbi.nlm.nih.gov/pubmed/37862090 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46552 %T Preference Elicitation and Treatment Decision-Making Among Men Diagnosed With Prostate Cancer: Randomized Controlled Trial Results of Healium %A Diefenbach,Michael A %A Marziliano,Allison %A Tagai,Erin K %A Pfister,Halie %A Lapitan,Emmanuel %A Hall,Simon J %A Vira,Manish %A Ibrahim,Said %A Aibel,Kelli %A Kutikov,Alexander %A Horwitz,Eric M %A Miyamoto,Curtis %A Reese,Adam C %A Miller,Suzanne M %+ Institute of Health System Science, The Feinstein Institutes for Medical Research, Northwell Health, 600 Community Drive, Suite 403, Manhasset, NY, 11030, United States, 1 516 600 1400, mdiefenbach@northwell.edu %K prostate cancer %K decision-making %K decision support %K decision tool %K web-based intervention %K patient preferences %K preference elicitation software %K preference %K RCT %K randomized controlled trial %K oncology %K prostate %K men’s health %K emotional %D 2023 %7 20.10.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Elicitation of patients’ preferences is an integral part of shared decision-making, the recommended approach for prostate cancer decision-making. Existing decision aids for this population often do not specifically focus on patients’ preferences. Healium is a brief interactive web-based decision aid that aims to elicit patients’ treatment preferences and is designed for a low health literate population. Objective: This study used a randomized controlled trial to evaluate whether Healium, designed to target preference elicitation, is as efficacious as Healing Choices, a comprehensive education and decision tool, in improving outcomes for decision-making and emotional quality of life. Methods: Patients diagnosed with localized prostate cancer who had not yet made a treatment decision were randomly assigned to the brief Healium intervention or Healing Choices, a decision aid previously developed by our group that serves as a virtual information center on prostate cancer diagnosis and treatment. Assessments were completed at baseline, 6 weeks, and 3 months post baseline, and included decisional outcomes (decisional conflict, satisfaction with decision, and preparation for decision-making), and emotional quality of life (anxiety/tension and depression), along with demographics, comorbidities, and health literacy. Results: A total of 327 individuals consented to participate in the study (171 were randomized to the Healium intervention arm and 156 were randomized to Healing Choices). The majority of the sample was non-Hispanic (272/282, 96%), White (239/314, 76%), married (251/320, 78.4%), and was on average 62.4 (SD 6.9) years old. Within both arms, there was a significant decrease in decisional conflict from baseline to 6 weeks postbaseline (Healium, P≤.001; Healing Choices, P≤.001), and a significant increase in satisfaction with one’s decision from 6 weeks to 3 months (Healium, P=.04; Healing Choices, P=.01). Within both arms, anxiety/tension (Healium, P=.23; Healing Choices, P=.27) and depression (Healium, P=.001; Healing Choices, P≤.001) decreased from baseline to 6 weeks, but only in the case of depression was the decrease statistically significant. Conclusions: Healium, our brief decision aid focusing on treatment preference elicitation, is as successful in reducing decisional conflict as our previously tested comprehensive decision aid, Healing Choices, and has the added benefit of brevity, making it the ideal tool for integration into the physician consultation and electronic medical record. Trial Registration: ClinicalTrials.gov NCT05800483; https://clinicaltrials.gov/study/NCT05800483 %M 37862103 %R 10.2196/46552 %U https://www.jmir.org/2023/1/e46552 %U https://doi.org/10.2196/46552 %U http://www.ncbi.nlm.nih.gov/pubmed/37862103 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 6 %N %P e44777 %T Examining the Impact of Selected Sociodemographic Factors and Cancer-Related Fatalistic Beliefs on Patient Engagement via Health Information Technology Among Older Adults: Cross-Sectional Analysis %A Zaidi,Maryum %A Gazarian,Priscilla %A Mattie,Heather %A Sheldon,Lisa Kennedy %A Gakumo,C Ann %+ Solomont School of Nursing, Zuckerberg College of Health Sciences, University of Massachusetts Lowell, 113 Wilder Street, Suite 291, Lowell, MA, 01854-3058, United States, 1 978 934 4776, maryum_zaidi@uml.edu %K health information technology %K patient portals %K older adults %K digital health %K self-management %K mobile phone %D 2023 %7 20.10.2023 %9 Original Paper %J JMIR Aging %G English %X Background: Despite the role of health information technology (HIT) in patient engagement processes and government incentives for HIT development, research regarding HIT is lacking among older adults with a high burden of chronic diseases such as cancer. This study examines the role of selected sociodemographic factors and cancer-related fatalistic beliefs on patient engagement expressed through HIT use for patient engagement in adults aged ≥65 years. We controlled for cancer diagnosis to account for its potential influence on patient engagement. Objective: This study has 2 aims: to investigate the role of sociodemographic factors such as race, education, poverty index, and psychosocial factors of cancer fatalistic beliefs in accessing and using HIT in older adults and to examine the association between access and use of HIT in the self-management domain of patient activation that serves as a precursor to patient engagement. Methods: This is a secondary data analysis of a subset of the Health Information National Trend Survey (Health Information National Trend Survey 4, cycle 3). The subset included individuals aged ≥65 years with and without a cancer diagnosis. The relationships between access to and use of HIT to several sociodemographic variables and psychosocial factors of fatalistic beliefs were analyzed. Logistic and linear regression models were fit to study these associations. Results: This study included 180 individuals aged ≥65 years with a cancer diagnosis and 398 without a diagnosis. This analysis indicated that having less than a college education level (P=<.001), being an individual from an ethnic and minority group (P=<.001), and living in poverty (P=.001) were significantly associated with decreased access to HIT. Reduced HIT use was associated with less than a college education (P=.001) and poverty(P=.02). This analysis also indicated that fatalistic beliefs about cancer were significantly associated with lower HIT use (P=.03). Specifically, a 1-point increase in the cancer fatalistic belief score was associated with a 36% decrease in HIT use. We found that controlling for cancer diagnosis did not affect the outcomes for sociodemographic variables or fatalistic beliefs about cancer. However, patients with access to HIT had a self-management domain of patient activation (SMD) score of 0.21 points higher (P=.003) compared with patients who did not have access. SMD score was higher by 0.28 points (P=.002) for individuals who used HIT and 0.14 points higher (P=.04) who had a prior diagnosis of cancer. Conclusions: Sociodemographic factors (education, race, poverty, and cancer fatalistic beliefs) impact HIT access and use in older adults, regardless of prior cancer diagnosis. Among older adults, HIT users report higher self-management, which is essential for patient activation and engagement. %M 37655786 %R 10.2196/44777 %U https://aging.jmir.org/2023/1/e44777 %U https://doi.org/10.2196/44777 %U http://www.ncbi.nlm.nih.gov/pubmed/37655786 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45678 %T Mobile Behavioral Health Coaching as a Preventive Intervention for Occupational Public Health: Retrospective Longitudinal Study %A Toh,Sean Han Yang %A Lee,Sze Chi %A Sündermann,Oliver %+ Intellect Private Limited Company, 171 Tras St, #02-179 Union Building, Singapore, 079025, Singapore, 65 93571995, oliver@intellect.co %K mobile health apps %K mHealth apps %K behavioral health coaching %K behavioral coaching %K app-based coaching %K self-help %K employees %K well-being %K mood %K stress %K public health %K preventive interventions %K positive psychology %D 2023 %7 20.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Researchers have recently proposed that behavioral health coaching (BHC) is effective in promoting proactive care among employees. However, to qualify as a preventive workplace intervention, more research is needed to evaluate whether BHC can further elevate well-being among moderately mentally healthy employees. Objective: Using real-world data, this study evaluates the preliminary effectiveness of app-based BHC against a nonrandomized control group with open access to self-help tools in improving well-being (ie, mood levels and perceived stress). The study also explores the active ingredients of BHC and dose-response associations between the number of BHC sessions and well-being improvements. Methods: Employees residing across Asia-Pacific countries (N=1025; mean age 30.85, SD 6.97 y) who reported moderately positive mood and medium levels of perceived stress in their first week of using the mental health app Intellect were included in this study. Users who were given access by their organizations to Intellect’s BHC services were assigned to the “Coaching” condition (512/1025, 49.95%; mean age 31.09, SD 6.87 y), whereas other employees remained as “Control” participants (513/1025, 50.05%; mean age 30.61, SD 7.06 y). To evaluate effectiveness, monthly scores from the validated mood and stress sliders were aggregated into a composite well-being score and further examined using repeated-measure conditional growth models. Postcoaching items on “Perceived Usefulness of the BHC session” and “Working Alliance with my Coach” were examined as active ingredients of BHC using 1-1-1 multilevel mediation models. Finally, 2-way repeated-measure mixed ANOVA models were conducted to examine dose-response effects on well-being improvements between groups (coaching and control) across time. Results: Growth curve analyses revealed significant time by group interaction effects for composite well-being, where “Coaching” users reported significantly greater improvements in well-being than “Control” participants across time (composite well-being: F1,391=6.12; ηp2=0.02; P=.01). Among “Coaching” participants, dependent-sample 2-tailed t tests revealed significant improvements in composite well-being from baseline to 11 months (t512=1.98; Cohen d=0.17; P=.049). Improvements in “Usefulness of the BHC session” (β=.078, 95% Cl .043-.118; P<.001) and “Working Alliance” (β=.070, 95% Cl .037-.107; P<.001) fully mediated within-level well-being enhancements over time. Comparing against baseline or first month scores, significant time by group interactions were observed between the second and sixth months, with the largest effect size observed at the fifth month mark (first month vs fifth month: F1,282=15.0; P<.001; ηp2=0.051). Conclusions: We found preliminary evidence that BHC is an effective preventive workplace intervention. Mobile-based coaching may be a convenient, cost-effective, and scalable means for organizations and governments to boost public mental health. %M 37862086 %R 10.2196/45678 %U https://formative.jmir.org/2023/1/e45678 %U https://doi.org/10.2196/45678 %U http://www.ncbi.nlm.nih.gov/pubmed/37862086 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e49357 %T Effects of Using Websites on Physical Activity and Diet Quality for Adults Living With Chronic Health Conditions: Systematic Review and Meta-Analysis %A Pogrebnoy,Dina %A Dennett,Amy M %A Simpson,Dawn B %A MacDonald-Wicks,Lesley %A Patterson,Amanda J %A English,Coralie %+ School of Health Sciences, University of Newcastle, University Dr, Callaghan, Newcastle, 2308, Australia, 61 403432415, dina.pogrebnoy@uon.edu.au %K modifiable risk factors %K secondary prevention %K physical activity %K diet quality %K websites %K chronic health %K chronic illness %D 2023 %7 19.10.2023 %9 Review %J J Med Internet Res %G English %X Background: Adults with chronic health conditions need support to manage modifiable risk factors such as physical inactivity and poor diet. Disease-specific websites with health information on physical activity and diet quality may be effective in supporting adults in managing their chronic illnesses. Objective: The primary aim of this review was to determine whether using websites with health information can lead to improvements in physical activity levels or diet quality in adults with chronic health conditions. Methods: Randomized controlled trials evaluating the effectiveness of website use on levels of physical activity or diet quality in adults with chronic health conditions were included. MEDLINE, Embase, CINAHL, and the Physiotherapy Evidence Database were searched from the earliest available record until February 2023. Data for outcomes measuring physical activity levels; diet quality; and, where reported, self-efficacy and quality of life were independently extracted by 2 reviewers. The risk of bias was assessed using the Physiotherapy Evidence Database scale, and the overall certainty of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation approach. Where values were presented as the same unit of measure, postintervention scores were pooled for meta-analysis to yield an overall mean difference (MD). A standardized MD (SMD) was calculated for the pooled data in which different units for the same outcome were used. Individual trial data were described in cases where the data of trials could not be pooled. Results: A total of 29 trials (N=6418 participants) across 8 different disease groups with intervention periods ranging from 4 weeks to 12 months were included in the analysis. There was moderate-certainty evidence that using websites with health information increased levels of moderate to vigorous physical activity (MD=39 min/wk, 95% CI 18.60-58.47), quality of life (SMD=0.36, 95% CI 0.12-0.59), and self-efficacy (SMD=0.26, 95% CI 0.05-0.48) and high-certainty evidence for reduction in processed meat consumption (MD=1.1 portions/wk, 95% CI 0.70-1.58) when compared with usual care. No differences were detected in other measures of diet quality. There was no increased benefit for website users who were offered additional support. Conclusions: The use of websites for risk factor management has the potential to improve physical activity levels, quality of life, and self-efficacy as well as reduce processed meat consumption for adults living with chronic health conditions when compared with usual care. However, it remains unclear whether using websites leads to meaningful and long-lasting behavior change. Trial Registration: PROSPERO CRD42021283168; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=283168 %M 37856187 %R 10.2196/49357 %U https://www.jmir.org/2023/1/e49357 %U https://doi.org/10.2196/49357 %U http://www.ncbi.nlm.nih.gov/pubmed/37856187 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46189 %T App-Controlled Treatment Monitoring and Support for Patients With Head and Neck Cancer Undergoing Radiotherapy: Results From a Prospective Randomized Controlled Trial %A Sprave,Tanja %A Pfaffenlehner,Michelle %A Stoian,Raluca %A Christofi,Eleni %A Rühle,Alexander %A Zöller,Daniela %A Fabian,Alexander %A Fahrner,Harald %A Binder,Harald %A Schäfer,Henning %A Gkika,Eleni %A Grosu,Anca-Ligia %A Heinemann,Felix %A Nicolay,Nils Henrik %+ Department of Radiation Oncology, University of Leipzig Medical Center, Stephanstr 9A, Leipzig, 04103, Germany, 49 34197 ext 18400, nils.nicolay@medizin.uni-leipzig.de %K mHealth %K head and neck cancer %K head and neck squamous cell carcinoma %K HNSCC %K radiotherapy %K mobile app %K quality of life %K patient-reported outcome measure %K PROM %K mobile health %K head %K neck %K cancer %K oncology %K radiation %K randomized controlled trial %K RCT %K satisfaction %K treatment surveillance %K patient surveillance %K feasibility %K patient reported %K outcome measure %K app-based %D 2023 %7 19.10.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Head and neck cancers (HNCs) are very common malignancies, and treatment often requires multimodal approaches, including radiotherapy and chemotherapy. Patients with HNC often display a high symptom burden, both due to the disease itself and the adverse effects of the multimodal therapy. Close telemonitoring of symptoms and quality of life during the course of treatment may help to identify those patients requiring early medical support. Objective: The App-Controlled Treatment Monitoring and Support for Patients With Head and Neck Cancer (APCOT) trial aimed to investigate the feasibility of integrating electronic patient-reported outcomes (ePROs) in the treatment surveillance pathway of patients with HNC during the course of their radiotherapy. Additionally, the influence of app-based ePRO monitoring on global and disease-specific quality of life and patient satisfaction with treatment was assessed. Methods: Patients undergoing radiotherapy for histologically proven HNCs at the Department of Radiation Oncology, University Medical Center Freiburg, Germany, were enrolled in this trial and monitored by weekly physician appointments. Patients were randomized between additional ePRO monitoring on each treatment day or standard-of-care monitoring. Feasibility of ePRO monitoring was defined as ≥80% of enrolled patients answering ≥80% of their daily app-based questions. Quality of life and patient satisfaction were assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30), the head and neck cancer module (H&N35), and the validated Patient Satisfaction Questionnaire Short Form (PSQ-18) at the completion of treatment and compared between trial arms. Results: A total of 100 patients were enrolled in this trial, and 93 patients were evaluable. All patients (100%) in the experimental arm answered ≥80% of the ePRO questions during treatment, reaching the predefined threshold for the feasibility of ePRO monitoring (P<.001 in the binomial test). No clinical or patient-specific factor was found to influence feasibility. Global health and most domains of the general quality of life were comparable between trial arms, but an increased HNC-specific symptom burden was reported by patients undergoing ePRO surveillance. ePRO monitoring resulted in improved patient satisfaction regarding interpersonal manners (P=.01), financial aspects (P=.01), and time spent with a doctor (P=.01). Conclusions: This trial demonstrated the feasibility of incorporating daily app-based ePRO surveillance for patients with HNC undergoing radiotherapy. Our data, for the first time, demonstrate that telemonitoring in this setting led to increased reporting of HNC-specific symptom burden and significantly improved several domains of patient satisfaction. Further analyses are needed to assess whether our findings hold true outside the context of a clinical trial. Trial Registration: German Clinical Trials Register DRKS00020491; https://drks.de/search/en/trial/DRKS00020491 %M 37856185 %R 10.2196/46189 %U https://www.jmir.org/2023/1/e46189 %U https://doi.org/10.2196/46189 %U http://www.ncbi.nlm.nih.gov/pubmed/37856185 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45764 %T Evaluating the Effects of Rewards and Schedule Length on Response Rates to Ecological Momentary Assessment Surveys: Randomized Controlled Trials %A Edney,Sarah %A Goh,Claire Marie %A Chua,Xin Hui %A Low,Alicia %A Chia,Janelle %A S Koek,Daphne %A Cheong,Karen %A van Dam,Rob %A Tan,Chuen Seng %A Müller-Riemenschneider,Falk %+ Physical Activity and Nutrition Determinants in Asia Programme, Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, Singapore, 117549, Singapore, 65 6516 4988, sarah.edney@nus.edu.sg %K experience sampling %K ambulatory assessment %K compliance %K mobile phone %D 2023 %7 19.10.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Ecological momentary assessments (EMAs) are short, repeated surveys designed to collect information on experiences in real-time, real-life contexts. Embedding periodic bursts of EMAs within cohort studies enables the study of experiences on multiple timescales and could greatly enhance the accuracy of self-reported information. However, the burden on participants may be high and should be minimized to optimize EMA response rates. Objective: We aimed to evaluate the effects of study design features on EMA response rates. Methods: Embedded within an ongoing cohort study (Health@NUS), 3 bursts of EMAs were implemented over a 7-month period (April to October 2021). The response rate (percentage of completed EMA surveys from all sent EMA surveys; 30-42 individual EMA surveys sent/burst) for each burst was examined. Following a low response rate in burst 1, changes were made to the subsequent implementation strategy (SMS text message announcements instead of emails). In addition, 2 consecutive randomized controlled trials were conducted to evaluate the efficacy of 4 different reward structures (with fixed and bonus components) and 2 different schedule lengths (7 or 14 d) on changes to the EMA response rate. Analyses were conducted from 2021 to 2022 using ANOVA and analysis of covariance to examine group differences and mixed models to assess changes across all 3 bursts. Results: Participants (N=384) were university students (n=232, 60.4% female; mean age 23, SD 1.3 y) in Singapore. Changing the reward structure did not significantly change the response rate (F3,380=1.75; P=.16). Changing the schedule length did significantly change the response rate (F1,382=6.23; P=.01); the response rate was higher for the longer schedule (14 d; mean 48.34%, SD 33.17%) than the shorter schedule (7 d; mean 38.52%, SD 33.44%). The average response rate was higher in burst 2 and burst 3 (mean 50.56, SD 33.61 and mean 48.34, SD 33.17, respectively) than in burst 1 (mean 25.78, SD 30.12), and the difference was statistically significant (F2,766=93.83; P<.001). Conclusions: Small changes to the implementation strategy (SMS text messages instead of emails) may have contributed to increasing the response rate over time. Changing the available rewards did not lead to a significant difference in the response rate, whereas changing the schedule length did lead to a significant difference in the response rate. Our study provides novel insights on how to implement EMA surveys in ongoing cohort studies. This knowledge is essential for conducting high-quality studies using EMA surveys. Trial Registration: ClinicalTrials.gov NCT05154227; https://clinicaltrials.gov/ct2/show/NCT05154227 %M 37856188 %R 10.2196/45764 %U https://www.jmir.org/2023/1/e45764 %U https://doi.org/10.2196/45764 %U http://www.ncbi.nlm.nih.gov/pubmed/37856188 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e44658 %T The Effectiveness of Fully Automated Digital Interventions in Promoting Mental Well-Being in the General Population: Systematic Review and Meta-Analysis %A Groot,Julia %A MacLellan,Alexander %A Butler,Madelaine %A Todor,Elisa %A Zulfiqar,Mahnoor %A Thackrah,Timothy %A Clarke,Christopher %A Brosnan,Mark %A Ainsworth,Ben %+ Department of Psychology, University of Bath, Claverton Down, Bath, BA2 7AY, United Kingdom, 44 01225 383800, jmdg20@bath.ac.uk %K mental well-being %K promotion %K intervention %K digital %K web-based %K apps %K mobile phone %D 2023 %7 19.10.2023 %9 Review %J JMIR Ment Health %G English %X Background: Recent years have highlighted an increasing need to promote mental well-being in the general population. This has led to a rapidly growing market for fully automated digital mental well-being tools. Although many individuals have started using these tools in their daily lives, evidence on the overall effectiveness of digital mental well-being tools is currently lacking. Objective: This study aims to review the evidence on the effectiveness of fully automated digital interventions in promoting mental well-being in the general population. Methods: Following the preregistration of the systematic review protocol on PROSPERO, searches were carried out in MEDLINE, Web of Science, Cochrane, PsycINFO, PsycEXTRA, Scopus, and ACM Digital (initial searches in February 2022; updated in October 2022). Studies were included if they contained a general population sample and a fully automated digital intervention that exclusively used psychological mental well-being promotion activities. Two reviewers, blinded to each other’s decisions, conducted data selection, extraction, and quality assessment of the included studies. Narrative synthesis and a random-effects model of per-protocol data were adopted. Results: We included 19 studies that involved 7243 participants. These studies included 24 fully automated digital mental well-being interventions, of which 15 (63%) were included in the meta-analysis. Compared with no intervention, there was a significant small effect of fully automated digital mental well-being interventions on mental well-being in the general population (standardized mean difference 0.19, 95% CI 0.04-0.33; P=.02). Specifically, mindfulness-, acceptance-, commitment-, and compassion-based interventions significantly promoted mental well-being in the general population (P=.006); insufficient evidence was available for positive psychology and cognitive behavioral therapy–based interventions; and contraindications were found for integrative approaches. Overall, there was substantial heterogeneity, which could be partially explained by the intervention duration, comparator, and study outcomes. The risk of bias was high, and confidence in the quality of the evidence was very low (Grading of Recommendations, Assessment, Development, and Evaluations), primarily because of the high rates of study dropout (average 37%; range 0%-85%) and suboptimal intervention adherence (average 40%). Conclusions: This study provides a novel contribution to knowledge regarding the effectiveness, strengths, and weaknesses of fully automated digital mental well-being interventions in the general population. Future research and practice should consider these findings when developing fully automated digital mental well-being tools. In addition, research should aim to investigate positive psychology and cognitive behavioral therapy–based tools as well as develop further strategies to improve adherence and reduce dropout in fully automated digital mental well-being interventions. Finally, it should aim to understand when and for whom these interventions are particularly beneficial. Trial Registration: PROSPERO CRD42022310702; https://tinyurl.com/yc7tcwy7 %M 37856172 %R 10.2196/44658 %U https://mental.jmir.org/2023/1/e44658 %U https://doi.org/10.2196/44658 %U http://www.ncbi.nlm.nih.gov/pubmed/37856172 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49558 %T Pilot Testing of an mHealth App for Tobacco Cessation in People Living With HIV: Protocol for a Pilot Randomized Controlled Trial %A Brin,Maeve %A Trujillo,Paul %A Jia,Haomiao %A Cioe,Patricia %A Huang,Ming-Chun %A Chen,Huan %A Qian,Xiaoye %A Xu,Wenyao %A Schnall,Rebecca %+ Columbia University School of Nursing, 560 W 168th St, New York City, NY, 10032, United States, 1 212 342 6886, rb897@cumc.columbia.edu %K addict %K addiction %K app %K application %K applications %K apps %K cessation %K cigar %K cigarette %K cigarettes %K HIV %K mHealth %K mobile health %K quit %K quitting %K randomized controlled trial %K RCT %K smartwatch %K smoker %K smoking cessation %K smoking %K tobacco %D 2023 %7 19.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: An estimated 40% of people living with HIV smoke cigarettes. Although smoking rates in the United States have been declining in recent years, people living with HIV continue to smoke cigarettes at twice the rate of the general population. Mobile health (mHealth) technology is an effective tool for people living with a chronic illness, such as HIV, as currently 84% of households in the United States report that they have a smartphone. Although many studies have used mHealth interventions for smoking cessation, few studies have recruited people living with HIV who smoke. Objective: The objective of the pilot randomized controlled trial (RCT) is to examine the feasibility, acceptability, and preliminary efficacy of the Sense2Quit App as a tool for people living with HIV who are motivated to quit smoking. Methods: The Sense2Quit study is a 2-arm RCT for people living with HIV who smoke cigarettes (n=60). Participants are randomized to either the active intervention condition, which consists of an 8-week supply of nicotine replacement therapy, standard smoking cessation counseling, and access to the Sense2Quit mobile app and smartwatch, or the control condition, which consists of standard smoking cessation counseling and a referral to the New York State Smokers’ Quitline. The Sense2Quit app is a mobile app connected through Bluetooth to a smartwatch that tracks smoking gestures and distinguishes them from other everyday hand movements. In the Sense2Quit app, participants can view their smoking trends, which are recorded through their use of the smartwatch, including how often or how much they smoke and the amount of money that they are spending on cigarettes, watch videos with quitting tips, information, and distractions, play games, set reminders, and communicate with a study team member. Results: Enrollment of study participants began in March 2023 and is expected to end in October 2023. All data collection is expected to be completed by the end of January 2024. This RCT will test the difference in outcomes between the control and intervention arms. The primary outcome will be the percentage of participants with biochemically verified 7-day point prevalence smoking or tobacco abstinence at their 12-week follow-up. Results from this pilot study will be disseminated to the research community following the completion of all data collection. Conclusions: The Sense2Quit study leverages mHealth so that it can help smokers improve their efforts at smoking cessation. Our research has the potential to not only increase quitting rates among people living with HIV who may need a prolonged, tailored intervention but also inform further development of mHealth for people living with HIV. This mHealth study will contribute significant findings to the greater mHealth research community, providing evidence as to how mHealth should be developed and tested among the target population. Trial Registration: ClinicalTrials.gov NCT05609032; https://clinicaltrials.gov/study/NCT05609032 International Registered Report Identifier (IRRID): DERR1-10.2196/49558 %M 37856173 %R 10.2196/49558 %U https://www.researchprotocols.org/2023/1/e49558 %U https://doi.org/10.2196/49558 %U http://www.ncbi.nlm.nih.gov/pubmed/37856173 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48386 %T Testing a Model of Care for Patients on Immune Checkpoint Inhibitors Based on Electronic Patient-Reported Outcomes: Protocol for a Randomized Phase II Controlled Trial %A da Silva Lopes,André Manuel %A Colomer-Lahiguera,Sara %A Darnac,Célia %A Giacomini,Stellio %A Bugeia,Sébastien %A Gutknecht,Garance %A Spurrier-Bernard,Gilliosa %A Cuendet,Michel %A Muet,Fanny %A Aedo-Lopez,Veronica %A Mederos,Nuria %A Michielin,Olivier %A Addeo,Alfredo %A Latifyan,Sofiya %A Eicher,Manuela %+ Institute of Higher Education and Research in Healthcare, Faculty of Biology and Medicine, University of Lausanne, Route de la Corniche 10, Bâtiment Proline, Lausanne, 1010, Switzerland, 41 21 314 87 60, manuela.eicher@chuv.ch %K patient-reported outcomes %K model of care %K immune-related adverse events %K remote symptom management %K self-management support %K self-efficacy %K health-related quality of life %K eHealth %K telehealth %K support %K self-management %K symptom %K monitoring %K cancer %K electronic health record %K immune %K detection %K questionnaire %K treatment %D 2023 %7 18.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Management of severe symptomatic immune-related adverse events (IrAEs) related to immune checkpoint inhibitors (ICIs) can be facilitated by timely detection. As patients face a heterogeneous set of symptoms outside the clinical setting, remotely monitoring and assessing symptoms by using patient-reported outcomes (PROs) may result in shorter delays between symptom onset and clinician detection. Objective: We assess the effect of a model of care for remote patient monitoring and symptom management based on PRO data on the time to detection of symptomatic IrAEs from symptom onset. The secondary objectives are to assess its effects on the time between symptomatic IrAE detection and intervention, IrAE grade (severity), health-related quality of life, self-efficacy, and overall survival at 6 months. Methods: For this study, 198 patients with cancer receiving systemic treatment comprising ICIs exclusively will be recruited from 2 Swiss university hospitals. Patients are randomized (1:1) to a digital model of care (intervention) or usual care (control group). Patients are enrolled for 6 months, and they use an electronic app to complete weekly Functional Assessment of Cancer Therapy-General questionnaire and PROMIS (PROs Measurement Information System) Self-Efficacy to Manage Symptoms questionnaires. The intervention patient group completes a standard set of 37 items in a weekly PROs version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire, and active symptoms are reassessed daily for the first 3 months by using a modified 24-hour recall period. Patients can add items from the full PRO-CTCAE item library to their questionnaire. Nurses call patients in the event of new or worsening symptoms and manage them by using a standardized triage algorithm based on the United Kingdom Oncology Nursing Society 24-hour triage tool. This algorithm provides guidance on deciding if patients should receive in-person care, if monitoring should be increased, or if self-management education should be reinforced. Results: The Institut Suisse de Recherche Expérimentale sur le Cancer Foundation and Kaiku Health Ltd funded this study. Active recruitment began since November 2021 and is projected to conclude in November 2023. Trial results are expected to be published in the first quarter of 2024 and will be disseminated through publications submitted at international scientific conferences. Conclusions: This trial is among the first trials to use PRO data to directly influence routine care of patients treated with ICIs and addresses some limitations in previous studies. This trial collects a wider spectrum of self-reported symptom data daily. There are some methodological limitations brought by changes in evolving treatment standards for patients with cancer. This trial's results could entail further academic discussions on the challenges of diagnosing and managing symptoms associated with treatment remotely by providing further insights into the burden symptoms represent to patients and highlight the complexity of care procedures involved in managing symptomatic IrAEs. Trial Registration: ClinicalTrials.gov NCT05530187; https://www.clinicaltrials.gov/study/NCT05530187 International Registered Report Identifier (IRRID): DERR1-10.2196/48386 %M 37851498 %R 10.2196/48386 %U https://www.researchprotocols.org/2023/1/e48386 %U https://doi.org/10.2196/48386 %U http://www.ncbi.nlm.nih.gov/pubmed/37851498 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46852 %T Perinatal Women’s Perspectives of, and Engagement in, Digital Emotional Well-Being Training: Mixed Methods Study %A Davis,Jacqueline A %A Ohan,Jeneva L %A Gregory,Sonia %A Kottampally,Keerthi %A Silva,Desiree %A Prescott,Susan L %A Finlay-Jones,Amy L %+ Telethon Kids Institute, 15 Hospital Avenue, Nedlands, 6009, Australia, 61 478173989, jackie.davis@telethonkids.org.au %K perinatal %K digital mental health interventions %K well-being %K mindfulness %K self-compassion %K engagement %K ORIGINS %D 2023 %7 17.10.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Psychological distress in the early postpartum period can have long-lasting deleterious effects on a mother’s well-being and negatively affect her infant’s development. Intervention approaches based in contemplative practices such as mindfulness and loving-kindness and compassion are intended to alleviate distress and cultivate well-being and can be delivered effectively as digital mental health interventions (DMHIs). Objective: To understand the feasibility of engaging perinatal women in digital interventions, this study aimed to document participants’ experiences in the Mums Minds Matter (MMM) study, a pilot randomized controlled trial comparing mindfulness, loving-kindness and compassion, and progressive muscle relaxation training delivered in a digital format and undertaken during pregnancy. To assess the different stages of engagement during and after the intervention, we adapted the connect, attend, participate, enact (CAPE) framework that is based on the idea that individuals go through different stages of engagement before they are able to enact change. Methods: The MMM study was nested within a longitudinal birth cohort, The ORIGINS Project. We aimed to recruit 25 participants per randomization arm. Data were collected sequentially during the intervention through regular web-based surveys over 8 weeks, with opportunities to provide regular feedback. In the postintervention phase, qualitative data were collected through purposive sampling. Results: Of 310 eligible women, 84 (27.1% [connect rate]) enrolled to participate in MMM. Of the remaining 226 women who did not proceed to randomization, 223 (98.7%) failed to complete the baseline surveys and timed out of eligibility (after 30 weeks’ gestation), and 3 (1.3%) displayed high psychological distress scores. Across all program groups, 17 (20% [attend rate]) of the 84 participants actively opted out, although more may have disengaged from the intervention but did not withdraw. The main reasons for withdrawal were busy life and other priorities. In this study, we assessed active engagement and ongoing skills use (participate and enact) through postintervention interviews. We undertook 15 participant interviews, conducted 1 month to 3 months after the intervention. Our results provide insights into participant barriers and enablers as well as app changes, such as the ability to choose topics, daily reminders, case studies, and diversity in sounds. Implementing a DMHI that is brief, includes frequent prompts or nudges, and is easily accessible is a key strategy to target perinatal women. Conclusions: Our research will enable future app designs that are sufficiently nuanced to maximize the uptake, engagement, and application of mental health skills and contemplative practices in the perinatal period. Providing convenient access to engaging and effective prevention programs is critical and should be part of prenatal self-care. Our research underscores the appeal and feasibility of digital intervention approaches based in contemplative practices for perinatal women. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) 12620000672954p; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000672954p International Registered Report Identifier (IRRID): RR2-10.2196/19803 %M 37847537 %R 10.2196/46852 %U https://www.jmir.org/2023/1/e46852 %U https://doi.org/10.2196/46852 %U http://www.ncbi.nlm.nih.gov/pubmed/37847537 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 7 %N %P e48454 %T Pilot Investigation of Blood Pressure Control Using a Mobile App (Cardi.Health): Retrospective Chart Review Study %A Nakrys,Marius %A Valinskas,Sarunas %A Aleknavicius,Kasparas %A Jonusas,Justinas %+ Lithuania Business University of Applied Sciences, Turgaus st 21, Klaipėda, 91249, Lithuania, 370 26 311 099, justinas.jonusas@ltvk.lt %K mobile app %K Cardi.Health %K blood pressure %K engagement %K app %K pilot study %K hypertension %K effective %K blood pressure control %K self-monitoring %K medication %K management %K engagement %K users %K use %D 2023 %7 17.10.2023 %9 Original Paper %J JMIR Cardio %G English %X Background: The high prevalence of hypertension necessitates effective, scalable interventions for blood pressure (BP) control. Self-monitoring has shown improved adherence to medication and better BP management. Mobile apps offer a promising approach with their increasing popularity and potential for large-scale implementation. Studies have demonstrated associations between mobile app interventions and lowered BP, yet real-world data on app effectiveness and engagement remain limited. Objective: In this study, we analyzed real-world user data from the Cardi.Health mobile app, which is aimed at helping its users monitor and control their BP. Our goal was to find out whether there is an association between the use of the mobile app and a decrease in BP. Additionally, the study explored how engagement with the app may influence this outcome. Methods: This was a retrospective chart review study. The initial study population comprised 4407 Cardi.Health users who began using the app between January 2022 and April 2022. After applying inclusion criteria, the final study cohort comprised 339 users with elevated BP at the baseline. The sample consisted of 108 (31.9%) men and 231 (68.1%) women (P=.04). This retrospective chart review study obtained permission from the Biomedical Research Alliance of New York Institutional Review Board (June 2022, registration ID 22-08-503-939). Results: The study’s main findings were that there is a possible relationship between use of the Cardi.Health mobile app and a decrease in systolic BP. Additionally, there was a significant association between active use of the app and systolic BP decrease (χ21=5.311; P=.02). Finally, active users had an almost 2 times greater chance of reducing systolic BP by 5 mm Hg or more over 4 weeks (odds ratio 1.932, 95% CI 1.074-3.528; P=.03). Conclusions: This study shows a possible relationship between Cardi.Health mobile app use and decreased BP. Additionally, engagement with the app may be related to better results—active use was associated with an almost 2-fold increase in the odds of reducing BP by 5 or more mm Hg. %M 37847544 %R 10.2196/48454 %U https://cardio.jmir.org/2023/1/e48454 %U https://doi.org/10.2196/48454 %U http://www.ncbi.nlm.nih.gov/pubmed/37847544 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46209 %T Virtual Reality Meditation for Fatigue in Persons With Rheumatoid Arthritis: Mixed Methods Pilot Study %A Dreesmann,Nathan J %A Buchanan,Diana %A Tang,Hsin-Yi Jean %A Furness III,Thomas %A Thompson,Hilaire %+ Virtual Therapeutics, 13905 NE 128th St, Suite 200, Kirkland, WA, 98034, United States, 1 (425) 821 8001, nathan.dreesmann@vthera.com %K anxiety %K chronic pain %K depression %K fatigue %K feasibility study %K feasibility %K head-mounted display %K meditation %K mixed method %K mood %K pain %K rheumatoid arthritis %K symptom %K virtual reality %K VR %D 2023 %7 17.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Effective symptom management is crucial to enhancing the quality of life for individuals with chronic diseases. Health care has changed markedly over the past decade as immersive, stand-alone, and wearable technologies including virtual reality have become available. One chronic pain population that could benefit from such an intervention is individuals with rheumatoid arthritis (RA). Recent pharmacologic advances in the management of RA have led to a decrease in inflammatory symptoms (eg, chronic pain) or even disease remission, yet up to 70% of patients with RA still suffer from fatigue. While VR-delivered behavior, meditation, and biofeedback programs show promise for pain and anxiety management, there is little information on the use of virtual reality meditation (VRM) for fatigue management among individuals with RA. Objective: This study aims to (1) examine the feasibility of implementing a study protocol that uses VRM, (2) determine the acceptability of using VRM for fatigue management in an outpatient population, and (3) identify barriers and contextual factors that might impact VRM use for fatigue management in outpatients with RA. Methods: We used a convergent, mixed methods design and enrolled adults aged 18 years or older with a clinical diagnosis of RA. Patient-Reported Outcome Measure Information System (PROMIS) measures of fatigue, depression, anxiety, pain behavior, and physical function were assessed alongside the brief mood introspection scale at baseline and weekly for 4 weeks. VRM use across the 4-week study period was automatically stored on headsets and later extracted for analysis. Semistructured interview questions focused on feedback regarding the participant’s experience with RA, previous experience of fatigue, strategies participants use for fatigue management, and the participant’s experience using VRM and recommendations for future use. Results: A total of 13 participants completed this study. Most participants completed all study surveys and measures (11/13, 84% and 13/13, 100%, respectively) and were active participants in interviews at the beginning and end of the program. Participants used VRM an average of 8.9 (SD 8.5) times over the course of the 4-week program. Most participants enjoyed VRM, found it relaxing, or recommended its use (12/13, 92%), but 8 (62%) noted barriers and conceptual factors that impacted VRM use. On average, participants saw decreases in PROMIS fatigue (–6.4, SD 5.1), depression (–5.6, SD 5.7), anxiety (–4.5, SD 6), and pain behavior (–3.9, SD 5.3), and improvements in PROMIS physical function (1.5, SD 2.7) and Brief Mood Introspection Scale mood (5.3, SD 6.7) over the course of this 4-week study. Conclusions: While this study’s implementation was feasible, VRM’s acceptability as an adjunctive modality for symptom management in RA is contingent on effectively overcoming barriers to use and thoughtfully addressing the contextual factors of those with RA to ensure successful intervention deployment. Trial Registration: ClinicalTrials.gov NCT04804462; https://classic.clinicaltrials.gov/ct2/show/NCT04804462 %M 37847542 %R 10.2196/46209 %U https://formative.jmir.org/2023/1/e46209 %U https://doi.org/10.2196/46209 %U http://www.ncbi.nlm.nih.gov/pubmed/37847542 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47443 %T Patient Perceptions of In Vivo Versus Virtual Reality Exposures for the Treatment of Anxiety Disorders: Cross-Sectional Survey Study %A Levy,Amanda N %A Nittas,Vasileios %A Wray,Tyler B %+ Department of Computer Science, Brown University, 115 Waterman St, Providence, RI, 02906, United States, 1 401 863 7600, amanda_levy@brown.edu %K counseling treatment %K phobias %K PTSD %K patient perspective %K in vivo exposures %K virtual reality %K exposure therapy %K anxiety %K psychotherapy %K effectiveness %K digital therapy %K affective disorders %D 2023 %7 16.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Psychotherapy, and particularly exposure therapy, has been proven to be an effective treatment for many anxiety disorders, including social and specific phobias, as well as posttraumatic stress disorders. Currently, exposures are underused and mostly delivered in vivo. Virtual reality exposure therapy (VRET) offers a more flexible delivery mechanism that has the potential to address some of the implementation barriers of in vivo exposures while retaining effectiveness. Yet, there is little evidence on how patients perceive different exposure therapy methods. Objective: This study aims to explore the perceptions of individuals with anxiety disorders toward in vivo and VRET. Our findings can inform therapists about the degree of patient interest in both methods while exploring the demand for VRET as an alternative and novel treatment approach. Methods: Web-based survey assessing the (1) interest in, (2) willingness to use, (3) comfort with, (4) enthusiasm toward, and (5) perceived effectiveness of exposure therapy when delivered in vivo and through VR. Participants included individuals with specific phobia, social phobia, posttraumatic stress disorder, or acute stress disorder or reaction. Participants were presented with educational videos about in vivo and VRET and asked to provide their perceptions quantitatively and qualitatively through a rated scale and free-text responses. Results: In total, 184 surveys were completed and analyzed, in which 82% (n=151) of participants reported being willing to receive in vivo exposures and 90.2% (n=166) reported willingness to receive VRET. Participants reported higher interest in, comfort with, enthusiasm toward, and perceived effectiveness of VRET compared to in vivo. Most reported in vivo concerns were linked to (1) increased anxiety, (2) feelings of embarrassment or shame, and (3) exacerbation of current condition. Most reported VRET concerns were linked to (1) risk of side effects including increased anxiety, (2) efficacy uncertainty, and (3) health insurance coverage. The most frequently mentioned VRET benefits include (1) privacy, (2) safety, (3) the ability to control exposures, (4) comfort, (5) the absence of real-life consequences, (6) effectiveness, and (7) customizability to a wider variety of exposures. Conclusions: On average, our participants expressed positive perceptions toward exposure therapy, with slightly more positive perceptions of VRET over in vivo exposures. Despite valid personal concerns and some misconceptions, our findings emphasize that VRET provides an opportunity to get much-needed therapy to patients in ways that are more acceptable and less concerning. %M 37843884 %R 10.2196/47443 %U https://formative.jmir.org/2023/1/e47443 %U https://doi.org/10.2196/47443 %U http://www.ncbi.nlm.nih.gov/pubmed/37843884 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e47266 %T Effect of Short, Animated Video Storytelling on Maternal Knowledge and Satisfaction in the Perinatal Period in South Africa: Randomized Controlled Trial %A Adam,Maya %A Kwinda,Zwannda %A Dronavalli,Mithilesh %A Leonard,Elizabeth %A Nguyễn,Vān Kính %A Tshivhase,Vusani %A Bärnighausen,Till %A Pillay,Yogan %+ Department of Pediatrics, Stanford University School of Medicine, 291 Campus Drive, Stanford, CA, 94305, United States, 1 6508393600, madam@stanford.edu %K maternal child health %K mHealth %K mobile health %K randomized controlled trial %K short animated storytelling %K South Africa %K video health messaging %D 2023 %7 13.10.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Innovative mobile health (mHealth) interventions can improve maternal knowledge, thereby supporting national efforts to reduce preventable maternal and child mortality in South Africa. Studies have documented a potential role for mobile video content to support perinatal health messaging, enhance maternal satisfaction, and overcome literacy barriers. Short, animated storytelling (SAS) is an innovative, emerging approach to mHealth messaging. Objective: We aimed to measure the effect of SAS videos on maternal knowledge and user satisfaction for mothers enrolled in antenatal care programs at 2 public health facilities in the Tshwane District of South Africa. Methods: We used a randomized controlled trial with a nested evaluation of user satisfaction. Participants were randomized 1:1 into Standard-of-Care (SOC) Control, and SAS Intervention groups. The intervention videos were delivered through WhatsApp, and 1 month later, participants responded to telephone surveys assessing their knowledge. The intervention group then participated in a nested evaluation of user satisfaction. Results: We surveyed 204 participants. Of them, 49.5% (101/204) were aged between 25 and 34 years. Almost all participants self-identified as Black, with the majority (190/204, 93.2%) having completed secondary school. The mean overall knowledge score was 21.92/28. We observed a slight increase of 0.28 (95% uncertainty interval [UI] –0.58 to 1.16) in the overall knowledge score in the intervention arm. We found that those with secondary education or above scored higher than those with only primary education by 2.24 (95% UI 0.76-4.01). Participants aged 35 years or older also scored higher than the youngest age group (18-24 years) by 1.83 (95% CI 0.39-3.33). Finally, the nested user satisfaction evaluation revealed high maternal satisfaction (4.71/5) with the SAS video series. Conclusions: While the SAS videos resulted in high user satisfaction, measured knowledge gains were small within a participant population that was already receiving perinatal health messages through antenatal clinics. The higher knowledge scores observed in older participants with higher education levels suggest that boosting maternal knowledge in younger mothers with lower education levels should continue to be a public health priority in South Africa. Given the high maternal satisfaction among the SAS video-users in this study, policy makers should consider integrating similar approaches into existing, broad-reaching perinatal health programs, such as MomConnect, to boost satisfaction and potentially enhance maternal engagement. While previous studies have shown the promise of animated video health education, most of this research has been conducted in high-income countries. More research in underresourced settings is urgently needed, especially as access to mobile technology increases in the Global South. Future studies should explore the effect of SAS videos on maternal knowledge in hard-to-reach populations with limited access to antenatal care, although real-world logistical challenges persist when implementing studies in underresourced South African populations. Trial Registration: Pan African Clinical Trials Registry PACTR202203673222680; https://tinyurl.com/362cpuny %M 37831505 %R 10.2196/47266 %U https://www.jmir.org/2023/1/e47266 %U https://doi.org/10.2196/47266 %U http://www.ncbi.nlm.nih.gov/pubmed/37831505 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e47198 %T User Engagement Clusters of an 8-Week Digital Mental Health Intervention Guided by a Relational Agent (Woebot): Exploratory Study %A Hoffman,Valerie %A Flom,Megan %A Mariano,Timothy Y %A Chiauzzi,Emil %A Williams,Andre %A Kirvin-Quamme,Andrew %A Pajarito,Sarah %A Durden,Emily %A Perski,Olga %+ Woebot Health, Inc., 535 Mission St, San Francisco, CA, 94107, United States, 1 4152739742, valerie_hoffman@woebothealth.com %K anxiety %K clustering %K depression %K digital health %K digital mental health intervention %K mental health %K relational agents %K user engagement %D 2023 %7 13.10.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: With the proliferation of digital mental health interventions (DMHIs) guided by relational agents, little is known about the behavioral, cognitive, and affective engagement components associated with symptom improvement over time. Obtaining a better understanding could lend clues about recommended use for particular subgroups of the population, the potency of different intervention components, and the mechanisms underlying the intervention’s success. Objective: This exploratory study applied clustering techniques to a range of engagement indicators, which were mapped to the intervention’s active components and the connect, attend, participate, and enact (CAPE) model, to examine the prevalence and characterization of each identified cluster among users of a relational agent-guided DMHI. Methods: We invited adults aged 18 years or older who were interested in using digital support to help with mood management or stress reduction through social media to participate in an 8-week DMHI guided by a natural language processing–supported relational agent, Woebot. Users completed assessments of affective and cognitive engagement, working alliance as measured by goal and task working alliance subscale scores, and enactment (ie, application of therapeutic recommendations in real-world settings). The app passively collected data on behavioral engagement (ie, utilization). We applied agglomerative hierarchical clustering analysis to the engagement indicators to identify the number of clusters that provided the best fit to the data collected, characterized the clusters, and then examined associations with baseline demographic and clinical characteristics as well as mental health outcomes at week 8. Results: Exploratory analyses (n=202) supported 3 clusters: (1) “typical utilizers” (n=81, 40%), who had intermediate levels of behavioral engagement; (2) “early utilizers” (n=58, 29%), who had the nominally highest levels of behavioral engagement in week 1; and (3) “efficient engagers” (n=63, 31%), who had significantly higher levels of affective and cognitive engagement but the lowest level of behavioral engagement. With respect to mental health baseline and outcome measures, efficient engagers had significantly higher levels of baseline resilience (P<.001) and greater declines in depressive symptoms (P=.01) and stress (P=.01) from baseline to week 8 compared to typical utilizers. Significant differences across clusters were found by age, gender identity, race and ethnicity, sexual orientation, education, and insurance coverage. The main analytic findings remained robust in sensitivity analyses. Conclusions: There were 3 distinct engagement clusters found, each with distinct baseline demographic and clinical traits and mental health outcomes. Additional research is needed to inform fine-grained recommendations regarding optimal engagement and to determine the best sequence of particular intervention components with known potency. The findings represent an important first step in disentangling the complex interplay between different affective, cognitive, and behavioral engagement indicators and outcomes associated with use of a DMHI incorporating a natural language processing–supported relational agent. Trial Registration: ClinicalTrials.gov NCT05672745; https://classic.clinicaltrials.gov/ct2/show/NCT05672745 %M 37831490 %R 10.2196/47198 %U https://www.jmir.org/2023/1/e47198 %U https://doi.org/10.2196/47198 %U http://www.ncbi.nlm.nih.gov/pubmed/37831490 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e47371 %T App-Based Mindfulness for Attenuation of Subjective and Physiological Stress Reactivity in a Population With Elevated Stress: Randomized Controlled Trial %A Kirk,Ulrich %A Staiano,Walter %A Hu,Emily %A Ngnoumen,Christelle %A Kunkle,Sarah %A Shih,Emily %A Clausel,Alicia %A Purvis,Clare %A Lee,Lauren %+ Department of Psychology, University of Southern Denmark, Campusvej 55, Odense, 5230, Denmark, 45 65502695, ukirk@health.sdu.dk %K Mindfulness %K mental health %K stress %K smartphone %K technology %K Headspace %K mobile phone %D 2023 %7 13.10.2023 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Stress-related mental health disorders have steadily increased and contributed to a worldwide disease burden with up to 50% experiencing a stress-related mental health disorder worldwide. Data suggest that only approximately 20%-65% of individuals receive treatment. This gap in receiving treatment may be attributed to barriers such as limited treatment access, negative stigma surrounding mental health treatment, approachability (ie, not having a usual treatment plan or provider), affordability (ie, lack of insurance coverage and high treatment cost), and availability (ie, long waits for appointments) leaving those who need treatment without necessary care. To mitigate the limited access mental health treatment, there has been a rise in the application and study of digital mental health interventions. As such, there is an urgent need and opportunity for effective digital mental health interventions to alleviate stress symptoms, potentially reducing adverse outcomes of stress-related disorders. Objective: This study examined if app-based guided mindfulness could improve subjective levels of stress and influence physiological markers of stress reactivity in a population with elevated symptoms of stress. Methods: The study included 163 participants who had moderate to high perceived stress as assessed by the Perceived Stress Scale (PSS-10). Participants were randomly allocated to 1 of 5 groups: a digital guided program designed to alleviate stress (Managing Stress), a digital mindfulness fundamentals course (Basics), digitally delivered breathing exercises, an active control intervention (Audiobook), and a Waitlist Control group. The 3 formats of mindfulness interventions (Managing Stress, Basics, and Breathing) all had a total duration of 300 minutes spanning 20-30 days. Primary outcome measures were perceived stress using the PSS-10, self-reported sleep quality using the Pittsburgh Sleep Quality Index, and trait mindfulness using the Mindful Attention Awareness Scale. To probe the effects of physiological stress, an acute stress manipulation task was included, specifically the cold pressor task (CPT). Heart rate variability was collected before, during, and after exposure to the CPT and used as a measure of physiological stress. Results: The results showed that PSS-10 and Pittsburgh Sleep Quality Index scores for the Managing Stress (all P<.001) and Basics (all P≤.002) groups were significantly reduced between preintervention and postintervention periods, while no significant differences were reported for the other groups. No significant differences among groups were reported for Mindful Attention Awareness Scale (P=.13). The physiological results revealed that the Managing Stress (P<.001) and Basics (P=.01) groups displayed reduced physiological stress reactivity between the preintervention and postintervention periods on the CPT. There were no significant differences reported for the other groups. Conclusions: These results demonstrate efficacy of app-based mindfulness in a population with moderate to high stress on improving self-reported stress, sleep quality, and physiological measures of stress during an acute stress manipulation task. Trial Registration: ClinicalTrials.gov NCT05832632; https://www.clinicaltrials.gov/ct2/show/NCT05832632 %M 37831493 %R 10.2196/47371 %U https://mhealth.jmir.org/2023/1/e47371 %U https://doi.org/10.2196/47371 %U http://www.ncbi.nlm.nih.gov/pubmed/37831493 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e41779 %T Commercially Available Mobile Apps With Family Behavioral Goal Setting and Tracking for Parents: Review and Quality Evaluation %A Weber,Summer Joy %A Mulvaney,Shelagh A %A Faiola,Anthony %A Brown,Madeline %A Koyama,Tatsuki %A Sun,Lili %A Goggans,Susanna Lynn %A Hull,Pamela Carmen %+ Markey Cancer Center, University of Kentucky, 760 Press Avenue, Suite 460, Lexington, KY, 40536, United States, 1 859 562 3233, pam.hull@uky.edu %K goal setting %K goal tracking %K nutrition %K health behavior %K nutrition %K parents %K children %K mobile apps %D 2023 %7 13.10.2023 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Goal setting and tracking are well established behavior change techniques. Little is known about the extent to which commercially available mobile apps are designed to guide parents in using these strategies, their evidence base, and their quality. Objective: This study aims to review commercially available apps that target parents in relation to setting and tracking behavioral goals for their children. The objectives were to classify the apps’ general characteristics, features, evidence base, and target behaviors and assess app quality overall and separately for apps that target health-related behaviors (HRBs) and apps without a health-related behavior (WHRB). Methods: Apps were identified using keyword searches in the Apple App Store and Google Play in the United States. Apps were included if their primary purpose was to assist with setting goals, tracking goals, tracking behaviors, or giving feedback pertaining to goals for children by parents. App characteristics and common features were documented and summarized. Two reviewers assessed app quality using the Mobile App Rating Scale (MARS). Descriptive statistics summarized the MARS total score, 4 quality subscales, and 6 app-specific items that reflect the perceived impact of the app on goal setting and tracking, overall and with subgroup analysis for HRB and WHRB apps. Results: Of the 21 apps identified, 16 (76%) met the review criteria. Overall, 9 apps defined and targeted the following HRBs: nutrition and mealtime (6/16, 38%), physical activity and screen time (5/16, 31%), sleep (7/16, 44%), and personal hygiene (6/16, 38%). Three apps targeted specific age groups (2 apps were for children aged 6-13 years and 1 app was for children aged ≥4 years). None of the apps provided tailored assessments or guidance for goal setting. None of the apps indicated that they were intended for the involvement of a health professional or had been tested for efficacy. The MARS total score indicated moderate app quality overall (mean 3.42, SD 0.49) and ranged from 2.5 to 4.2 out of 5 points. The Habitz app ranked highest on the MARS total score among HRB apps (score=4.2), whereas Thumsters ranked highest (score=3.9) among the WHRB apps. Subgroup analysis revealed a pattern of higher quality ratings in the HRB group than the WHRB group, including the mean MARS total score (mean 3.67, SD 0.34 vs mean 3.09, SD 0.46; P=.02); the engagement and information subscales; and the app-specific items about perceived impact on knowledge, attitudes, and behavior change. Conclusions: Several high-quality commercially available apps target parents to facilitate goal setting and tracking for child behavior change related to both health and nonhealth behaviors. However, the apps lack evidence of efficacy. Future research should address this gap, particularly targeting parents of young children, and consider individually tailored guided goal setting and involvement of health professionals. %M 37831486 %R 10.2196/41779 %U https://pediatrics.jmir.org/2023/1/e41779 %U https://doi.org/10.2196/41779 %U http://www.ncbi.nlm.nih.gov/pubmed/37831486 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47903 %T Enhancing Mental Health and Medication Adherence Among Men Who Have Sex With Men Recently Diagnosed With HIV With a Dialectical Behavior Therapy–Informed Intervention Incorporating mHealth, Online Skills Training, and Phone Coaching: Development Study Using Human-Centered Design Approach %A Wang,Liying %A Yuwen,Weichao %A Hua,Wenzhe %A Chen,Lingxiao %A Forsythe Cox,Vibh %A Zheng,Huang %A Ning,Zhen %A Zhao,Zhuojun %A Liu,Zhaoyu %A Jiang,Yunzhang %A Li,Xinran %A Guo,Yawen %A Simoni,Jane M %+ Department of Psychology, University of Washington, 3921 W Stevens Way NE, Seattle, WA, 98195, United States, 1 (206) 543 2640, liyingw@uw.edu %K intervention mapping %K participatory approach %K cultural adaptation %K dialectical behavior therapy %K DBT %K men who have sex with men %K MSM %K coping skill training %D 2023 %7 13.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Mental health problems are common among men who have sex with men (MSM) living with HIV and may negatively affect medication adherence. Psychosocial interventions designed to address these urgent needs are scarce in China. Incorporating behavioral health theories into intervention development strengthens the effectiveness of these interventions. The absence of a robust theoretical basis for interventions may also present challenges to identify active intervention ingredients. Objective: This study aims to systematically describe the development of a mobile health–based intervention for MSM recently diagnosed with HIV in China, including the theoretical basis for the content and the considerations for its technological delivery. Methods: We used intervention mapping (IM) to guide overall intervention development, a behavioral intervention technology model for technological delivery design, and a human-centered design and cultural adaptation model for intervention tailoring throughout all steps of IM. Results: The dialectical behavior therapy (DBT)–informed intervention, Turning to Sunshine, comprised 3 components: app-based individual skills learning, group-based skills training, and on-demand phone coaching. The theoretical basis for the intervention content is based on the DBT model of emotions, which fits our conceptualization of the intervention user’s mental health needs. The intervention aims to help MSM recently diagnosed with HIV (1) survive moments of high emotional intensity and strong action urges, (2) change emotional expression to regulate emotions, and (3) reduce emotional vulnerability, as well as (4) augment community resources for mental health services. Technological delivery considerations included rationale of the medium, complexity, and esthetics of information delivery; data logs; data visualization; notifications; and passive data collection. Conclusions: This study laid out the steps for the development of a DBT-informed mobile health intervention that integrated app-based individual learning, group-based skills training, and phone coaching. This intervention, Turning to Sunshine, aims to improve mental health outcomes for MSM newly diagnosed with HIV in China. The IM framework informed by human-centered design principles and cultural adaptation considerations offered a systematic approach to develop the current intervention and tailor it to the target intervention users. The behavioral intervention technology model facilitated the translation of behavioral intervention strategies into technological delivery components. The systematic development and reporting of the current intervention can serve as a guide for similar intervention studies. The content of the current intervention could be adapted for a broader population with similar emotional struggles to improve their mental health outcomes. %M 37831497 %R 10.2196/47903 %U https://formative.jmir.org/2023/1/e47903 %U https://doi.org/10.2196/47903 %U http://www.ncbi.nlm.nih.gov/pubmed/37831497 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44887 %T Acceptability and Feasibility of Online Support Groups for Mental Health Promotion in Brazilian Graduate Students During the COVID-19 Pandemic: Longitudinal Observational Study %A Prado,Aneliana da Silva %A Kohls,Elisabeth %A Baldofski,Sabrina %A Rummel-Kluge,Christine %A Freitas,Joanneliese de Lucas %+ Department of Psychiatry and Psychotherapy, Medical Faculty, Leipzig University, Semmelweisstraße 10, Haus 13, Leipzig, 04103, Germany, 49 3419724464, Aneliana.daSilvaPrado@medizin.uni-leipzig.de %K support group %K online group %K COVID-19 pandemic %K higher education %K graduate students %K university students %K mental health %K online intervention %K internet intervention %K e–mental health %K mental health promotion %K feasibility %K students %K acceptability %D 2023 %7 13.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The outbreak of the COVID-19 pandemic in 2020 aggravated already existing difficulties and added new challenges for students. Owing to the gap between needed and available psychological services, group interventions may offer a helpful strategy for student mental health promotion. Objective: This study aimed to investigate the acceptability and feasibility of a 4-week online support group program designed for mental health promotion tailored to graduate students at a Brazilian public university in the context of the COVID-19 pandemic (May 2022 to June 2022). Methods: Participants in the program took part in online support groups based on a pilot group facilitated by a trained clinical psychologist. Self-administered, standardized web-based questionnaires were assessed at the baseline (T0; before the intervention), postintervention (T2), and follow-up (T3; after 4-6 weeks) time points. We measured sociodemographic variables, treatment credibility and expectancy (Credibility and Expectancy Questionnaire), satisfaction (Client Satisfaction Questionnaire), negative effects of the intervention (Negative Effects Questionnaire), depressive symptoms (Patient Health Questionnaire–9 [PHQ-9]), and participants’ quality of life (abbreviated World Health Organization Quality of Life assessment). A 9–answer option questionnaire and open-ended questions also assessed the group’s perceived positive and negative outcomes. Results: The total sample comprised 32 participants. Most (23/32, 72%) were doctoral students. Credibility and expectancy scores were high. Participants’ satisfaction (Client Satisfaction Questionnaire) with the program was high at the postintervention (T2) and follow-up (T3) evaluations (T2: mean 28.66, SD 3.02; T3: mean 27.91, SD 3.02). Most participants reported that they could learn from other participants’ experiences (T2: 29/32, 91%; T3: 27/32, 84%) and felt encouraged to take better care of themselves (T2: 22/32, 69%; T3: 24/32, 75%). None of the participants reported that they had no benefits from the program. The PHQ-9 scores showed mild to moderate depressive symptoms (mean 9.59, SD 6.34), whereas the answers of 9% (3/32) of the participants to the PHQ-9 item 9 indicated suicidality at baseline (T0). Finally, the 4 domains of quality of life (physical: P=.01; psychological: P=.004; social: P=.02; and environmental: P<.001) showed a slight and statistically significant improvement at the postintervention evaluation (T0: mean 57.03, SD 15.39 to 59.64, SD 17.21; T2: mean 64.32, SD 11.97 to 68.75, SD 8.87). Conclusions: Online support groups for the mental health promotion of graduate students are feasible and can be especially useful for universities with students allocated to different cities. They are also satisfactory and may positively influence participants’ quality of life. Therefore, they can be considered a helpful mental health promotion strategy in the educational context. Further studies could evaluate these (or similar) programs under nonpandemic circumstances. %M 37831483 %R 10.2196/44887 %U https://formative.jmir.org/2023/1/e44887 %U https://doi.org/10.2196/44887 %U http://www.ncbi.nlm.nih.gov/pubmed/37831483 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48459 %T Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants: Protocol for a Pilot Sequential Multiple Assignment Randomized Trial %A Davis-Ewart,Leah %A Grov,Christian %A Verhagen,Rachel %A Manuel,Jennifer %A Viamonte,Michael %A Dilworth,Samantha %A O'Dell,Nicole %A Valentin,Omar %A Carr,Sidney %A Cherenack,Emily %A Henderson,Chelsea %A Doblecki-Lewis,Susanne %A Nahum-Shani,Inbal %A Carrico,Adam W %+ Health Promotion and Disease Prevention, Robert Stempel College of Public Health and Social Work, Florida International University, 11200 SW 8th Street, AHC5, #407, Miami, FL, 33199, United States, 1 305 348 2620, a.carrico@miami.edu %K cocaine %K contingency management %K methamphetamine %K motivational interviewing %K pre-exposure prophylaxis %K intervention %K men %K stimulant %K condom %K HIV testing %K prevention %K HIV %K effectiveness %K telehealth %K motivation %D 2023 %7 13.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Although pre-exposure prophylaxis (PrEP) could substantially mitigate HIV risk, sexual minority men who use stimulants commonly experience difficulties with engaging in PrEP clinical services. Motivational interviewing (MI) and contingency management (CM) reduce substance use and condomless anal sex (CAS) in this population, but these motivational enhancement interventions require modifications to promote engagement along the PrEP care continuum. Objective: PrEP Readiness Interventions for Supporting Motivation (PRISM) is a pilot sequential multiple assignment randomized trial testing the feasibility, acceptability, and preliminary effectiveness of distinct combinations of telehealth MI and CM in 70 cisgender sexual minority men who use stimulants that are not currently taking PrEP. Methods: A national sample was recruited via social networking applications to complete a baseline assessment and mail-in HIV testing. Those with nonreactive HIV results were randomized to receive either (1) a 2-session MI intervention focusing on PrEP use (session 1) and concomitant stimulant use or CAS (session 2) or (2) a CM intervention with financial incentives for documented evidence of PrEP clinical evaluation by a medical provider (US $50) and filling a PrEP prescription (US $50). At the 3-month follow-up assessment, participants who reported they had not filled a prescription for PrEP were randomized a second time to either (1) switch to a second-stage intervention (ie, MI+CM or CM+MI) or (2) continue with assessments only. Outcomes for both responders and nonresponders were reassessed at a 6-month follow-up. The primary outcome is documented evidence of filling a PrEP prescription over 6 months. Self-reported secondary outcomes include PrEP clinical evaluation by a medical provider, stimulant use, and CAS. Qualitative exit interviews were conducted with a subgroup of responders and nonresponders to characterize their experiences with the MI and CM interventions. Results: Implementation of PRISM underscores challenges in reaching sexual minority men who use stimulants to optimize HIV prevention efforts. Approximately 1 in 10 (104/1060) eligible participants have enrolled. Of the 104 who enrolled, 87 (84%) completed mail-in HIV testing. We delivered 5 preliminary HIV-positive results, including posttest counseling with referrals to confirmatory testing. Conclusions: Lessons learned from PRISM underscore the central importance of a flexible, participant-centered approach to support the engagement of sexual minority men who use stimulants. Leveraging telehealth platforms to deliver motivational enhancement interventions also expanded their reach and potential public health impact with this high-priority population. Further research is needed to determine the effectiveness of telehealth MI and CM for supporting PrEP use in sexual minority men who use stimulants. Trial Registration: ClinicalTrials.gov NCT04205487; https://clinicaltrials.gov/study/NCT04205487 International Registered Report Identifier (IRRID): DERR1-10.2196/48459 %M 37831485 %R 10.2196/48459 %U https://www.researchprotocols.org/2023/1/e48459 %U https://doi.org/10.2196/48459 %U http://www.ncbi.nlm.nih.gov/pubmed/37831485 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e50108 %T Mindfulness-Based App to Reduce Stress in Caregivers of Persons With Alzheimer Disease and Related Dementias: Protocol for a Single-Blind Feasibility Proof-of-Concept Randomized Controlled Trial %A Woodworth,Emily C %A Briskin,Ellie A %A Plys,Evan %A Macklin,Eric %A Tatar,Raquel G %A Huberty,Jennifer %A Vranceanu,Ana-Maria %+ Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, One Bowdoin Square, Suite 100, Boston, MA, 02114, United States, 1 617 643 4123, avranceanu@mgh.harvard.edu %K caregiver %K dementia %K mindfulness %K mobile app %K protocol %K randomized controlled trial %D 2023 %7 13.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Informal caregivers (ie, individuals who provide assistance to a known person with health or functional needs, often unpaid) experience high levels of stress. Caregiver stress is associated with negative outcomes for both caregivers and care recipients. Mindfulness-based interventions (MBIs) show promise for improving stress, emotional distress, and sleep disturbance in caregivers of persons with Alzheimer disease and related dementias (ADRD). Commercially available mobile mindfulness apps can deliver MBIs to caregivers of persons with ADRD in a feasible and cost-effective manner. Objective: We are conducting a single-blind feasibility proof-of-concept randomized controlled trial (RCT; National Institutes of Health [NIH] stage 1B) comparing 2 free mobile apps: the active intervention Healthy Minds Program (HMP) with within-app text tailored for addressing stress among caregivers of persons with ADRD, versus Wellness App (WA), a time- and dose-matched educational control also tailored for caregivers of persons with ADRD. Methods: We aim to recruit 80 geographically diverse and stressed caregivers of persons with ADRD. Interested caregivers use a link or QR code on a recruitment flyer to complete a web-based eligibility screener. Research assistants conduct enrollment phone calls, during which participants provide informed consent digitally. After participants complete baseline surveys, we randomize them to the mindfulness-based intervention (HMP) or educational control podcast app (WA) and instruct them to listen to prescribed content for 10 minutes per day (70 minutes per week) for 12 weeks. Caregivers are blinded to intervention versus control. The study team checks adherence weekly and contacts participants to promote adherence as needed. Participants complete web-based self-report measures at baseline, posttest, and follow-up; weekly process measures are also completed. Primary outcomes are a priori set feasibility benchmarks. Secondary outcomes are stress, emotional distress, sleep disturbance, caregiver burden, mindfulness, awareness, connection, insight, and purpose. We will calculate 1-sided 95% CI to assess feasibility benchmarks. Effect sizes of change in outcomes will be used to examine the proof of concept. Results: Recruitment started on February 20, 2023. We have enrolled 27 caregivers (HMP: n=14; WA: n=13) as of June 2023. Funding began in August 2022, and we plan to finish enrollment by December 2023. Data analysis is expected to begin in May 2024 when all follow-ups are complete; publication of findings will follow. Conclusions: Through this trial, we aim to establish feasibility benchmarks for HMP and WA, as well as establish a proof of concept that HMP improves stress (primary quantitative outcome), emotional distress, sleep, and mindfulness more than WA. Results will inform a future efficacy trial (NIH stage II). HMP has the potential to be a cost-effective solution to reduce stress in caregivers of persons with ADRD, benefiting caregiver health and quality of care as well as patient care. Trial Registration: ClinicalTrials.gov NCT05732038; https://clinicaltrials.gov/study/NCT05732038 International Registered Report Identifier (IRRID): DERR1-10.2196/50108 %M 37831492 %R 10.2196/50108 %U https://www.researchprotocols.org/2023/1/e50108 %U https://doi.org/10.2196/50108 %U http://www.ncbi.nlm.nih.gov/pubmed/37831492 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49918 %T The DrinksRation Smartphone App for Modifying Alcohol Use Behaviors in UK Military Service Personnel at Risk of Alcohol-Related Harm: Protocol for a Randomized Controlled Trial %A King,Kate %A Leightley,Daniel %A Greenberg,Neil %A Fear,Nicola %+ Academic Department of Military General Practice, Research & Clinical Innovation, Defence Medical Services, ICT Centre, Birmingham Research Park, Vincent Drive, Birmingham, B152SQ, United Kingdom, 44 7901221593, kboddy@doctors.org.uk %K alcohol drinking %K alcohol brief intervention %K digital intervention %K military %D 2023 %7 13.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Consumption of alcohol is synonymous with military populations, and studies have shown that serving personnel drink more than age- and sex-matched civilian populations. While ingrained in the military culture, excessive alcohol use is associated with increased rates of disciplinary issues, sickness absence, and loss of productivity, as well as contributing to a burden of acute and chronic health problems. Alcohol brief interventions can reduce alcohol use in civilian populations, but there is a paucity of evidence relating to the effectiveness of similar interventions in military populations. The DrinksRation smartphone app was designed to have a basis in behavior change technique theory and focuses on providing interactive behavioral prompts tailored to a military population. It has previously been shown to be effective in a help-seeking veteran population. Objective: The primary aim of the Military DrinksRation randomized controlled trial study is to determine whether it is similarly effective in a serving military population. Methods: We compare the effectiveness of the DrinksRation smartphone app with treatment as usual for personnel identified at risk of alcohol-related harm using the Military DrinksRation study that is a 2-arm, single-blind, 1:1 randomized controlled trial of the UK Armed Forces population. It is hypothesized that the DrinksRation app will be more efficacious at reducing alcohol consumption compared to treatment as usual. Recruitment will be predominantly from routine, periodic dental inspections all service personnel regularly undertake, supplemented by recruitment from military-targeted media messaging. The primary outcome is the change in alcohol units consumed per week between baseline and day 84, measured using the timeline follow-back method. Secondary outcome measures are a change in the Alcohol Use Disorders Identification Test score, a change in the quality of life assessment, and a change in drinking motivations and app usability (intervention arm only) between baseline and day 84. A final data collection at 168 days will assess the persistence of any changes over a longer duration. Results: The study is expected to open in August 2023 and aims to enroll 728 participants to allow for a study sample size requirement of 218 per arm and a 40% attrition rate. It is expected to take up to 12 months to complete. The results will be published in 2024. Conclusions: The Military DrinksRation study will assess the efficacy of the smartphone app on changing alcohol use behaviors in service personnel. If a positive effect is shown, the UK Defence Medical Services would have an effective, evidence-based tool to use as part of an alcohol management clinical pathway, thereby providing better support for military personnel at risk of harm from alcohol drinking. Trial Registration: ISRCTN Registry 42646;. https://doi.org/10.1186/ISRCTN14977034 International Registered Report Identifier (IRRID): PRR1-10.2196/49918 %M 37831507 %R 10.2196/49918 %U https://www.researchprotocols.org/2023/1/e49918 %U https://doi.org/10.2196/49918 %U http://www.ncbi.nlm.nih.gov/pubmed/37831507 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e51320 %T A Digital Music-Based Mindfulness Intervention (“healing attempt”) for Race-Based Anxiety in Black Americans %A Jones,Grant %A Castro-Ramirez,Franchesca %A McGuire,Taylor %A Al-Suwaidi,Maha %A Herrmann,Felipe %+ Department of Psychology, Harvard University, 33 Kirkland Street, Cambridge, MA, 02138, United States, gmj005@g.harvard.edu %K Black music %K mindfulness %K meditation %K music %K song %K songs %K psychotherapy %K self-compassion %K ethnic %K cultural %K culturally %K single-case experiment %K race %K racial %K anxiety %K digital health intervention %K Black %K digital health %K low income %K Black community %K racial disparity %K mental health %D 2023 %7 12.10.2023 %9 Research Letter %J J Med Internet Res %G English %X This study replicates and extends findings that “healing attempt”—a brief digital music-based mindfulness intervention—represents a feasible and potentially effective intervention for race-based anxiety in the Black community. %M 37824179 %R 10.2196/51320 %U https://www.jmir.org/2023/1/e51320 %U https://doi.org/10.2196/51320 %U http://www.ncbi.nlm.nih.gov/pubmed/37824179 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46188 %T Researched Apps Used in Dementia Care for People Living With Dementia and Their Informal Caregivers: Systematic Review on App Features, Security, and Usability %A Ye,Bing %A Chu,Charlene H %A Bayat,Sayeh %A Babineau,Jessica %A How,Tuck-Voon %A Mihailidis,Alex %+ Occupational Science and Occupational Therapy, University of Toronto, 500 University Ave, Toronto, ON, M5G 1V7, Canada, 1 416 597 3422 ext 7910, bing.ye@utoronto.ca %K mobile technologies %K mobile apps %K dementia %K privacy %K security %K usability testing %K informal caregivers %K mobile phone %D 2023 %7 12.10.2023 %9 Review %J J Med Internet Res %G English %X Background: Studies have shown that mobile apps have the potential to serve as nonpharmacological interventions for dementia care, improving the quality of life of people living with dementia and their informal caregivers. However, little is known about the needs for and privacy aspects of these mobile apps in dementia care. Objective: This review seeks to understand the landscape of existing mobile apps in dementia care for people living with dementia and their caregivers with respect to app features, usability testing, privacy, and security. Methods: ACM Digital Library, Cochrane Central Register of Controlled Trials, Compendex, Embase, Inspec, Ovid MEDLINE, PsycINFO, and Scopus were searched. Studies were included if they included people with dementia living in the community, their informal caregivers, or both; focused on apps in dementia care using smartphones or tablet computers; and covered usability evaluation of the app. Records were independently screened, and 2 reviewers extracted the data. The Centre for Evidence-Based Medicine critical appraisal tool and Mixed Methods Appraisal Tool were used to assess the risk of bias in the included studies. Thematic synthesis was used, and the findings were summarized and tabulated based on each research aim. Results: Overall, 44 studies were included in this review, with 39 (89%) published after 2015. In total, 50 apps were included in the study, with more apps developed for people living with dementia as end users compared with caregivers. Most studies (27/44, 61%) used tablet computers. The most common app feature was cognitive stimulation. This review presented 9 app usability themes: user interface, physical considerations, screen size, interaction challenges, meeting user needs, lack of self-awareness of app needs, stigma, technological inexperience, and technical support. In total, 5 methods (questionnaires, interviews, observations, logging, and focus groups) were used to evaluate usability. There was little focus on the privacy and security aspects, including data transfer and protection, of mobile apps for people living with dementia. Conclusions: The limitations of this review include 1 reviewer conducting the full-text screening, its restriction to studies published in English, and the exclusion of apps that lacked empirical usability testing. As a result, there may be an incomplete representation of the available apps in the field of dementia care. However, this review highlights significant concerns related to the usability, privacy, and security of existing mobile apps for people living with dementia and their caregivers. The findings of this review provide a valuable framework to guide app developers and researchers in the areas of privacy policy development, app development strategies, and the importance of conducting thorough usability testing for their apps. By considering these factors, future work in this field can be advanced to enhance the quality and effectiveness of dementia care apps. Trial Registration: PROSPERO CRD42020216141; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=216141 International Registered Report Identifier (IRRID): RR2-10.1159/000514838 %M 37824187 %R 10.2196/46188 %U https://www.jmir.org/2023/1/e46188 %U https://doi.org/10.2196/46188 %U http://www.ncbi.nlm.nih.gov/pubmed/37824187 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e41035 %T Intrinsic Capacity and Active and Healthy Aging Domains Supported by Personalized Digital Coaching: Survey Study Among Geriatricians in Europe and Japan on eHealth Opportunities for Older Adults %A Stara,Vera %A Soraci,Luca %A Takano,Eiko %A Kondo,Izumi %A Möller,Johanna %A Maranesi,Elvira %A Luzi,Riccardo %A Riccardi,Giovanni Renato %A Browne,Ryan %A Dacunha,Sébastien %A Palmier,Cecilia %A Wieching,Rainer %A Ogawa,Toshimi %A Bevilacqua,Roberta %+ Medical Direction, IRCCS, INRCA, Via Santa Margherita 5, Ancona, 60124, Italy, 39 0718004767, e.maranesi@inrca.it %K intrinsic capacity %K functional ability, active and healthy aging %K digital coaching %K eHealth interventions %K older adults %D 2023 %7 12.10.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: The worldwide aging trend requires conceptually new prevention, care, and innovative living solutions to support human-based care using smart technology, and this concerns the whole world. Enabling access to active and healthy aging through personalized digital coaching services like physical activity coaching, cognitive training, emotional well-being, and social connection for older adults in real life could offer valuable advantages to both individuals and societies. A starting point might be the analysis of the perspectives of different professionals (eg, geriatricians) on such technologies. The perspectives of experts in the sector may allow the individualization of areas of improvement of clinical interventions, supporting the positive perspective pointed out by the intrinsic capacity framework. Objective: The overall aim of this study was to explore the cross-national perspectives and experiences of different professionals in the field of intrinsic capacity, and how it can be supported by eHealth interventions. To our knowledge, this is the first study to explore geriatric care providers’ perspectives about technology-based interventions to support intrinsic capacity. Methods: A survey involving 20 geriatricians or clinical experts in the fields of intrinsic capacity and active and healthy aging was conducted in Italy, France, Germany, and Japan between August and September 2021. Results: The qualitative findings pointed out relevant domains for eHealth interventions and provided examples for successful practices that support subjective well-being under the intrinsic capacity framework (the benefits offered by personalized interventions, especially by promoting health literacy but avoiding intrusiveness). Moreover, eHealth interventions could be used as a bridge that facilitates and enables social engagement; an instrument that facilitates communication between doctors and patients; and a tool to enrich the monitoring actions of medical staff. Conclusions: There is an unexplored and significant role for such geriatric perspectives to help the development process and evaluate the evidence-based results on the effectiveness of technologies for older people. This is possible only when clinicians collaborate with data scientists, engineers, and developers in order to match the complex daily needs of older adults. %M 37824183 %R 10.2196/41035 %U https://www.jmir.org/2023/1/e41035 %U https://doi.org/10.2196/41035 %U http://www.ncbi.nlm.nih.gov/pubmed/37824183 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 10 %N %P e49813 %T Effects of Real-Time Pressure Map Feedback on Confidence in Pressure Management in Wheelchair Users With Spinal Cord Injury: Pilot Intervention Study %A Vos-Draper,Tamara L %A Morrow,Melissa M B %A Ferguson,John E %A Mathiowetz,Virgil G %+ Center for Allied Health Professions, Program in Occupational Therapy, University of Minnesota, Center for Allied Programs, 420 Delaware Street South East, Minneapolis, MN, 55455, United States, 1 5072588256, vosdr001@umn.edu %K spinal cord injury %K wheelchair %K pressure injury prevention %K self-efficacy %K pressure mapping %K pressure %K mapping %K map %K interface %K spine %K spinal cord %K feedback %K real time %K mobile phone %D 2023 %7 12.10.2023 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: Wheelchair users with a spinal cord injury (SCI) are at a high risk for developing pressure injuries (PIs). Performing weight shifts is a primary method of pressure management for PI prevention; however, individuals with SCI may lack confidence in their abilities to perform adequate pressure relief due to their lack of sensation. Real-time seat interface pressure mapping feedback may provide partial substitution for sensory feedback such that an individual’s confidence is improved. Objective: We aim to examine how confidence for pressure management by wheelchair users with SCI was impacted by providing access to real-time, on-demand seat interface pressure mapping feedback. Methods: Adults with SCI (N=23) completed self-efficacy questions addressing confidence around 4 factors related to performing weight shifts in this longitudinal, repeated-measures study. We evaluated the impact of providing standard PI prevention education and access to live pressure map feedback on confidence levels for performing weight shifts. Results: Access to live pressure map feedback while learning how to perform weight shifts resulted in significantly higher confidence about moving far enough to relieve pressure at high-risk areas. Confidence for adhering to the recommended weight shift frequency and duration was not significantly impacted by in-clinic education or use of pressure map feedback. Confidence that performing weight shifts reduces PI risk increased most following education, with slight additional increase when pressure map feedback was added. Conclusions: Access to live pressure mapping feedback improves confidence about performing weight shifts that relieve pressure when provided in the clinical setting and demonstrates potential for the same in the home. This preliminary exploration of a smartphone-based pressure mapping intervention highlights the value of access to continuous pressure mapping feedback to improve awareness and confidence for managing pressure. Trial Registration: ClinicalTrials.gov NCT03987243; https://clinicaltrials.gov/study/NCT03987243 %M 37824188 %R 10.2196/49813 %U https://rehab.jmir.org/2023/1/e49813 %U https://doi.org/10.2196/49813 %U http://www.ncbi.nlm.nih.gov/pubmed/37824188 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 8 %N %P e46654 %T An Evidence-Based Framework for Creating Inclusive and Personalized mHealth Solutions—Designing a Solution for Medicaid-Eligible Pregnant Individuals With Uncontrolled Type 2 Diabetes %A Fareed,Naleef %A Swoboda,Christine %A Wang,Yiting %A Strouse,Robert %A Hoseus,Jenelle %A Baker,Carrie %A Joseph,Joshua J %A Venkatesh,Kartik %+ Department of Biomedical Informatics, College of Medicine, The Ohio State University, 370 W. 9th Avenue, Columbus, OH, 43210, United States, 1 6143660283, naleef.fareed@osumc.edu %K personalization %K mobile health %K mHealth %K pregnancy %K pregnant %K maternal %K personalized %K diabetic %K algorithm %K diabetes %K rule-based algorithms %K social determinants of health %K inclusive %K inclusivity %K design %D 2023 %7 12.10.2023 %9 Viewpoint %J JMIR Diabetes %G English %X Mobile health (mHealth) apps can be an evidence-based approach to improve health behavior and outcomes. Prior literature has highlighted the need for more research on mHealth personalization, including in diabetes and pregnancy. Critical gaps exist on the impact of personalization of mHealth apps on patient engagement, and in turn, health behaviors and outcomes. Evidence regarding how personalization, engagement, and health outcomes could be aligned when designing mHealth for underserved populations is much needed, given the historical oversights with mHealth design in these populations. This viewpoint is motivated by our experience from designing a personalized mHealth solution focused on Medicaid-enrolled pregnant individuals with uncontrolled type 2 diabetes, many of whom also experience a high burden of social needs. We describe fundamental components of designing mHealth solutions that are both inclusive and personalized, forming the basis of an evidence-based framework for future mHealth design in other disease states with similar contexts. %M 37824196 %R 10.2196/46654 %U https://diabetes.jmir.org/2023/1/e46654 %U https://doi.org/10.2196/46654 %U http://www.ncbi.nlm.nih.gov/pubmed/37824196 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e48843 %T Patient Experience of Digitalized Follow-up of Antidepressant Treatment in Psychiatric Outpatient Care: Qualitative Analysis %A Hamlin,Matilda %A Holmén,Joacim %A Wentz,Elisabet %A Aiff,Harald %A Ali,Lilas %A Steingrimsson,Steinn %+ Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Universitetsplatsen 1, Gothenburg, 405 30, Sweden, 46 31786 00 00, steinn.steingrimsson@vgregion.se %K major depressive disorder %K digital psychiatry %K mobile app %K adherence %K antidepressant %K antidepressants %K depressive %K depression %K mHealth %K mobile health %K app %K apps %K application %K applications %K experience %K interview %K interviews %K medication %K prescribe %K prescription %K dose %D 2023 %7 11.10.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Nonadherence to pharmaceutical antidepressant treatment is common among patients with depression. Digitalized follow-up (ie, self-monitoring systems through mobile apps) has been suggested as an effective adjunct to conventional antidepressant treatment to increase medical adherence, improve symptoms of depression, and reduce health care resource use. Objective: The aim of this study was to determine patients’ experience of digitalized follow-up using a mobile app as an adjunct to treatment concurrent with a new prescription, a change of antidepressant, or a dose increase. Methods: This was a qualitative, descriptive study. Patients at 2 psychiatric outpatient clinics were recruited at the time of changing antidepressant medication. After using a mobile app (either a commercial app or a public app) for 4-6 weeks with daily registrations of active data, such as medical intake and questions concerning general mental health status, individual semistructured interviews were conducted. Recorded data were transcribed and then analyzed using content analysis. Results: In total, 13 patients completed the study. The mean age was 35 (range 20-67) years, 8 (61.5%) were female, and all reported high digital literacy. Overall, the emerging themes indicated that the patients found the digital app to be a valuable adjunct to antidepressant treatment but with potential for improvement. Both user adherence and medical adherence were positively affected by a daily reminder and the app’s ease of use. User adherence was negatively affected by the severity of depression. The positive experience of visually presented data as graphs was a key finding, which was beneficial for self-awareness, the patient-physician relationship, and user adherence. Finally, the patients had mixed reactions to the app’s content and requested tailored content. Conclusions: The patients identified several factors addressing both medical adherence and user adherence to a digital app when using it for digitalized follow-up concurrent with the critical time related to changes in antidepressant medication. The findings highlight the need for rigorous evidence-based empirical studies to generate sustainable research results. %M 37819697 %R 10.2196/48843 %U https://mental.jmir.org/2023/1/e48843 %U https://doi.org/10.2196/48843 %U http://www.ncbi.nlm.nih.gov/pubmed/37819697 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e48362 %T A Digital Mental Health Support Program for Depression and Anxiety in Populations With Attention-Deficit/Hyperactivity Disorder: Feasibility and Usability Study %A Tsirmpas,Charalampos %A Nikolakopoulou,Maria %A Kaplow,Sharon %A Andrikopoulos,Dimitrios %A Fatouros,Panagiotis %A Kontoangelos,Konstantinos %A Papageorgiou,Charalabos %+ Feel Therapeutics Inc., 479 Jessie Street, San Francisco, CA, CA94103, United States, 1 3124784041, dimitris@feeltherapeutics.com %K precision medicine %K internet-based intervention %K mobile apps %K major depressive disorder %K anxiety disorders %K attention-deficit/hyperactivity disorder %K personalized medicine %K comorbidity %K quality of life %K mobile phone %D 2023 %7 11.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: A total of 1 in 2 adults with attention-deficit/hyperactivity disorder (ADHD) struggles with major depressive or anxiety disorders. The co-occurrence of these disorders adds to the complexity of finding utility in as well as adherence to a treatment option. Digital therapeutic solutions may present a promising alternative treatment option that could mitigate these challenges and alleviate symptoms. Objective: This study aims to investigate (1) the feasibility and acceptance of a digital mental health intervention, (2) participants’ engagement and retention levels, and (3) the potential efficacy with respect to anxiety and depression symptoms in a population with ADHD. Our main hypothesis was that a digital, data-driven, and personalized intervention for adults with coexisting ADHD and depressive or anxiety symptoms would show high engagement and adherence, which would be accompanied by a decrease in depressive and anxiety symptoms along with an increase in quality of life and life satisfaction levels. Methods: This real-world data, single-arm study included 30 adult participants with ADHD symptomatology and coexisting depressive or anxiety symptoms who joined a 16-week digital, data-driven mental health support program. This intervention is based on a combination of evidence-based approaches such as cognitive behavioral therapy, mindfulness, and positive psychology techniques. The targeted symptomatology was evaluated using the Patient Health Questionnaire–9, Generalized Anxiety Disorder–7, and Barkley Adult ADHD Rating Scale–IV. Quality of life aspects were evaluated using the Satisfaction With Life Scale and the Life Satisfaction Questionnaire, and user feedback surveys were used to assess user experience and acceptability. Results: The study retention rate was 97% (29/30), and high engagement levels were observed, as depicted by the 69 minutes spent on the app per week, 5 emotion logs per week, and 11.5 mental health actions per week. An average decrease of 46.2% (P<.001; r=0.89) in depressive symptoms and 46.4% (P<.001; r=0.86) in anxiety symptoms was observed, with clinically significant improvement for more than half (17/30, 57% and 18/30, 60%, respectively) of the participants. This was followed by an average increase of 23% (P<.001; r=0.78) and 20% (P=.003; r=0.8) in Satisfaction With Life Scale and Life Satisfaction Questionnaire scores, respectively. The overall participant satisfaction level was 4.3 out of 5. Conclusions: The findings support the feasibility, acceptability, and value of the examined digital program for adults with ADHD symptomatology to address the coexisting depressive or anxiety symptoms. However, controlled trials with larger sample sizes and more diverse participant profiles are required to provide further evidence of clinical efficacy. %M 37819688 %R 10.2196/48362 %U https://formative.jmir.org/2023/1/e48362 %U https://doi.org/10.2196/48362 %U http://www.ncbi.nlm.nih.gov/pubmed/37819688 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49252 %T An eHealth App (CAPABLE) Providing Symptom Monitoring, Well-Being Interventions, and Educational Material for Patients With Melanoma Treated With Immune Checkpoint Inhibitors: Protocol for an Exploratory Intervention Trial %A Fraterman,Itske %A Wollersheim,Barbara M %A Tibollo,Valentina %A Glaser,Savannah Lucia Catherina %A Medlock,Stephanie %A Cornet,Ronald %A Gabetta,Matteo %A Gisko,Vitali %A Barkan,Ella %A di Flora,Nicola %A Glasspool,David %A Kogan,Alexandra %A Lanzola,Giordano %A Leizer,Roy %A Mallo,Henk %A Ottaviano,Manuel %A Peleg,Mor %A van de Poll-Franse,Lonneke V %A Veggiotti,Nicole %A Śniatała,Konrad %A Wilk,Szymon %A Parimbelli,Enea %A Quaglini,Silvana %A Rizzo,Mimma %A Locati,Laura Deborah %A Boekhout,Annelies %A Sacchi,Lucia %A Wilgenhof,Sofie %+ Department of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam, 1066CX, Netherlands, 31 621885919, i.fraterman@nki.nl %K eHealth %K melanoma %K fatigue %K quality of life %K intervention %K pilot study %K QoL %K cancer %K oncology %K HRQoL %K fatigue %K symptom %K symptoms %K monitoring %K adoption %K acceptance %K patient education %K digital health %K immune checkpoint inhibitors %K immunotherapy %D 2023 %7 11.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Since treatment with immune checkpoint inhibitors (ICIs) is becoming standard therapy for patients with high-risk and advanced melanoma, an increasing number of patients experience treatment-related adverse events such as fatigue. Until now, studies have demonstrated the benefits of using eHealth tools to provide either symptom monitoring or interventions to reduce treatment-related symptoms such as fatigue. However, an eHealth tool that facilitates the combination of both symptom monitoring and symptom management in patients with melanoma treated with ICIs is still needed. Objective: In this pilot study, we will explore the use of the CAPABLE (Cancer Patients Better Life Experience) app in providing symptom monitoring, education, and well-being interventions on health-related quality of life (HRQoL) outcomes such as fatigue and physical functioning, as well as patients’ acceptance and usability of using CAPABLE. Methods: This prospective, exploratory pilot study will examine changes in fatigue over time in 36 patients with stage III or IV melanoma during treatment with ICI using CAPABLE (a smartphone app and multisensory smartwatch). This cohort will be compared to a prospectively collected cohort of patients with melanoma treated with standard ICI therapy. CAPABLE will be used for a minimum of 3 and a maximum of 6 months. The primary endpoint in this study is the change in fatigue between baseline and 3 and 6 months after the start of treatment. Secondary end points include HRQoL outcomes, usability, and feasibility parameters. Results: Study inclusion started in April 2023 and is currently ongoing. Conclusions: This pilot study will explore the effect, usability, and feasibility of CAPABLE in patients with melanoma during treatment with ICI. Adding the CAPABLE system to active treatment is hypothesized to decrease fatigue in patients with high-risk and advanced melanoma during treatment with ICIs compared to a control group receiving standard care. The Medical Ethics Committee NedMec (Amsterdam, The Netherlands) granted ethical approval for this study (reference number 22-981/NL81970.000.22). Trial Registration: ClinicalTrials.gov NCT05827289; https://clinicaltrials.gov/study/NCT05827289 International Registered Report Identifier (IRRID): DERR1-10.2196/49252 %M 37819691 %R 10.2196/49252 %U https://www.researchprotocols.org/2023/1/e49252 %U https://doi.org/10.2196/49252 %U http://www.ncbi.nlm.nih.gov/pubmed/37819691 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e48395 %T HD-DRUM, a Tablet-Based Drumming Training App Intervention for People With Huntington Disease: App Development Study %A Metzler-Baddeley,Claudia %A Busse,Monica %A Drew,Cheney %A Pallmann,Philip %A Cantera,Jaime %A Ioakeimidis,Vasileios %A Rosser,Anne %+ Cardiff University Brain Research Imaging Centre (CUBRIC), School of Psychology, Cardiff University, Maindy Road, Cathays, Cardiff, CF24 4HQ, United Kingdom, 44 29 208 ext 70705, Metzler-BaddeleyC@cardiff.ac.uk %K Huntington disease %K electronic health %K intervention %K training application %K rhythm %K timing %K drumming %K movement %K cognition %K integrated knowledge translation %K gamification %K Template for Intervention Description and Replication (TIDieR) %K TIDieR %K mobile phone %D 2023 %7 6.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Huntington disease (HD) is a neurodegenerative condition that leads to progressive loss of cognitive-executive and motor functions, largely due to basal ganglia (BG) atrophy. Currently, there are no therapeutic interventions tailored to address executive and motor dysfunction in people with HD. Music-based interventions may aid executive abilities by compensating for impaired BG-reliant timing and rhythm generation using external rhythmic beats. Here, we applied an integrated knowledge translation (IKT) framework to co-design a tablet-based rhythmic drumming training app (HD-DRUM) to stimulate executive and motor abilities in people with HD. Objective: The primary aim was to develop the HD-DRUM app for at-home use that addressed the accessibility needs of people with HD and allowed for the quantification of performance improvements and adherence for controlled clinical evaluation. Methods: The IKT framework was applied to iteratively refine the design of HD-DRUM. This process involved 3 phases of knowledge user engagement and co-design: a web-based survey of people with HD (n=29) to inform about their accessibility needs, usability testing of tablet-based touch screens as hardware solutions, and usability testing of the design and build of HD-DRUM to meet the identified accessibility needs of people affected by HD and their clinicians (n=12). Results: The survey identified accessibility problems due to cognitive and motor control impairments such as difficulties in finding and navigating through information and using PC keyboards and mouses to interact with apps. Tablet-based touch screens were identified as feasible and accessible solutions for app delivery. Key elements to ensure that the app design and build met the needs of people with HD were identified and implemented. These included the facilitation of intuitive navigation through the app using large and visually distinctive buttons; the use of audio and visual cues as training guides; and gamification, positive feedback, and drumming to background music as a means to increase motivation and engagement. The co-design development process resulted in the proof-of-concept HD-DRUM app that is described here according to the Template for Intervention Description and Replication checklist. HD-DRUM can be used at home, allowing the quantification of performance improvements and adherence for clinical evaluation, matching of training difficulty to users’ performance levels using gamification, and future scale-up to reach a wide range of interested users. Conclusions: Applying an IKT-based co-design framework involving knowledge user engagement allowed for the iterative refinement of the design and build of the tablet-based HD-DRUM app intervention, with the aim of stimulating BG-reliant cognitive and motor functions. Mapping the intervention against the Template for Intervention Description and Replication framework to describe complex interventions allowed for the detailed description of the HD-DRUM intervention and identification of areas that required refinement before finalizing the intervention protocol. %M 37801351 %R 10.2196/48395 %U https://formative.jmir.org/2023/1/e48395 %U https://doi.org/10.2196/48395 %U http://www.ncbi.nlm.nih.gov/pubmed/37801351 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e48152 %T Mental Health Self-Tracking Preferences of Young Adults With Depression and Anxiety Not Engaged in Treatment: Qualitative Analysis %A Beltzer,Miranda L %A Meyerhoff,Jonah %A Popowski,Sarah A %A Mohr,David C %A Kornfield,Rachel %+ Center for Behavior Intervention Technologies, Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL, 60611, United States, 1 312 503 6585, miranda.beltzer@northwestern.edu %K self-tracking %K self-monitoring %K self-help %K depression %K anxiety %K young adults %K mHealth %K technology %K qualitative analysis %K focus group %K personal informatics %K mood %K thematic analysis %D 2023 %7 6.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Despite the high prevalence of anxiety and depression among young adults, many do not seek formal treatment. Some may turn to digital mental health tools for support instead, including to self-track moods, behaviors, and other variables related to mental health. Researchers have sought to understand processes and motivations involved in self-tracking, but few have considered the specific needs and preferences of young adults who are not engaged in treatment and who seek to use self-tracking to support mental health. Objective: This study seeks to assess the types of experiences young adults not engaged in treatment have had with digital self-tracking for mood and other mental health data and to assess how young adults not seeking treatment want to engage in self-tracking to support their mental health. Methods: We conducted 2 online asynchronous discussion groups with 50 young adults aged 18 years to 25 years who were not engaged in treatment. Participants were recruited after indicating moderate to severe symptoms of depression or anxiety on screening surveys hosted on the website of Mental Health America. Participants who enrolled in the study responded anonymously to discussion prompts on a message board, as well as to each other’s responses, and 3 coders performed a thematic analysis of their responses. Results: Participants had mixed experiences with self-tracking in the past, including disliking when tracking highlighted unwanted behaviors and discontinuing tracking for a variety of reasons. They had more positive past experiences tracking behaviors and tasks they wanted to increase, using open-ended journaling, and with gamified elements to increase motivation. Participants highlighted several design considerations they wanted self-tracking tools to address, including building self-understanding; organization, reminders, and structure; and simplifying the self-tracking experience. Participants wanted self-tracking to help them identify their feelings and how their feelings related to other variables like sleep, exercise, and events in their lives. Participants also highlighted self-tracking as useful for motivating and supporting basic activities and tasks of daily living during periods of feeling overwhelmed or low mood and providing a sense of accomplishment and stability. Although self-tracking can be burdensome, participants were interested and provided suggestions for simplifying the process. Conclusions: These young adults not engaged in treatment reported interest in using self-tracking to build self-understanding as a goal in and of itself or as a first step in contemplating and preparing for behavior change or treatment-seeking. Alexithymia, amotivation, and feeling overwhelmed may serve both as barriers to self-tracking and opportunities for self-tracking to help. %M 37801349 %R 10.2196/48152 %U https://formative.jmir.org/2023/1/e48152 %U https://doi.org/10.2196/48152 %U http://www.ncbi.nlm.nih.gov/pubmed/37801349 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46926 %T Assessment of the SmartJournal Intervention for Improved Oral Care in Nursing Homes: Protocol for a Cluster Randomized Controlled Trial %A Melbye,Elisabeth Lind %A Bull,Vibeke Hervik %A Hidle,Kristin Søllesvik %+ Research Department, Oral Health Centre of Expertise Rogaland, P.O. Box 130 Sentrum, Stavanger, 4001, Norway, 47 93093299, elisabeth.lind.melbye@throg.no %K cluster randomized controlled trial %K digital tool %K gerodontology %K intervention %K nursing homes %K oral health %D 2023 %7 6.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Poor oral health is common in nursing home residents, and health care professionals report numerous barriers when it comes to the provision of oral care for care-dependent older adults, such as a lack of oral health knowledge and skills, care-resistant behaviors in residents, lack of adequate oral care routines, insufficient systems for documentation of issues related to oral health, a high workload, and unclear responsibilities. An intervention, SmartJournal, has been developed to assist health personnel in preserving older patients’ oral health. SmartJournal is a digital tool with three components: (1) documentation of oral hygiene routines; (2) monthly oral health assessment; and (3) education on geriatric oral care. An updated framework for research on complex interventions has been used to guide the various phases in the development of this intervention. This study focuses on the evaluation phase. Objective: We aim to assess (1) the effectiveness of SmartJournal use in enhancing nursing home caregivers’ capability, opportunity, motivation, and routines related to oral care; and (2) whether SmartJournal use results in improved oral health for nursing home residents. Methods: We will use a cluster randomized controlled trial to assess impacts of SmartJournal use as specified under study objectives. Nursing homes located in Rogaland, Norway, will be recruited and randomly assigned to an intervention and a control group. The intervention group will be provided with tablets containing SmartJournal and support from research staff, while the control group will continue with existing oral care routines. Both groups will receive oral hygiene packages. The intervention will last for 12 weeks. Measurements will be performed in both groups at baseline, 3 months, and 9 months and include (1) a survey assessing caregivers’ capability, opportunity, motivation, and routines related to oral care; and (2) assessment of oral health status in residents using mucosal-plaque score as a primary outcome measure. Analyses will include descriptive statistics and statistical techniques to look for changes and differences in the study variables within and between the intervention and control groups throughout the study period. Associations between study variables will also be investigated. Results: Recruitment of nursing homes for the intervention and control groups was completed in February 2023. Recruitment of individual participants (ie, nursing home residents and caregivers) is ongoing, and baseline measurements are being performed consecutively. Results are expected to be ready for analyses in fall 2024. Conclusions: We aim to assess the effects of SmartJournal use on oral care and oral health in nursing homes. Results from this work may inform further development and implementation of SmartJournal and similar digital tools aiming to enhance health care services offered to care-dependent people. Finally, SmartJournal may have potential as a learning tool in educational programs for nurses and other health care professionals. Trial Registration: ClinicalTrials.gov NCT05724043; https://clinicaltrials.gov/study/NCT05724043 International Registered Report Identifier (IRRID): DERR1-10.2196/46926 %M 37801358 %R 10.2196/46926 %U https://www.researchprotocols.org/2023/1/e46926 %U https://doi.org/10.2196/46926 %U http://www.ncbi.nlm.nih.gov/pubmed/37801358 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e49342 %T Longitudinal Evaluation of an Integrated Post–COVID-19/Long COVID Management Program Consisting of Digital Interventions and Personal Support: Randomized Controlled Trial %A Derksen,Christina %A Rinn,Robin %A Gao,Lingling %A Dahmen,Alina %A Cordes,Cay %A Kolb,Carina %A Becker,Petra %A Lippke,Sonia %+ Health Psychology and Behavioural Medicine, Constructor University Bremen, Campus Ring 1, Bremen, 28759, Germany, 49 421 200 4730, cderksen@constructor.university %K postacute COVID-19 syndrome %K PACS %K symptom reduction %K work ability %K social participation %K personal pilots %K digital interventions %K empowerment %K randomized controlled trial %K propensity score matching %K COVID-19 %D 2023 %7 4.10.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: The postacute COVID-19 syndrome (PACS) can be addressed with multidisciplinary approaches, including professional support and digital interventions. Objective: This research aimed to test whether patients who received a health care facilitation program including medical internet support from human personal pilots and digital interventions (intervention group [IG] and active control group [ACG]) would experience fewer symptoms and have higher work ability and social participation than an untreated comparison group (CompG). The second objective was to compare the impact of a diagnostic assessment and digital interventions tailored to patients’ personal capacity (IG) with that of only personal support and digital interventions targeting the main symptoms (ACG). Methods: In total, 1020 patients with PACS were recruited. Using a randomized controlled trial design between the IG and the ACG, as well as propensity score matching to include the CompG, analyses were run with logistic regression and hierarchical-linear models. Results: Symptoms decreased significantly in all groups over time (βT1-T2=0.13, t549=5.67, P<.001; βT2-T4=0.06, t549=2.83, P=.01), with a main effect of the group (β=–.15, t549=–2.65, P=.01) and a more pronounced effect in the IG and ACG compared to the CompG (between groups: βT1-T2=0.14, t549=4.31, P<.001; βT2-T4=0.14, t549=4.57, P<.001). Work ability and social participation were lower in the CompG, but there was no significant interaction effect. There were no group differences between the IG and the ACG. Conclusions: Empowerment through personal pilots and digital interventions reduces symptoms but does not increase work ability and social participation. More longitudinal research is needed to evaluate the effects of a diagnostic assessment. Social support and digital interventions should be incorporated to facilitate health care interventions for PACS. Trial Registration: ClinicalTrials.gov NCT05238415; https://classic.clinicaltrials.gov/ct2/show/NCT05238415. International Registered Report Identifier (IRRID): RR2-10.1186/s12879-022-07584-z %M 37792437 %R 10.2196/49342 %U https://www.jmir.org/2023/1/e49342 %U https://doi.org/10.2196/49342 %U http://www.ncbi.nlm.nih.gov/pubmed/37792437 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e49998 %T The Appa Health App for Youth Mental Health: Development and Usability Study %A Giovanelli,Alison %A Sanchez Karver,Tahilin %A Roundfield,Katrina D %A Woodruff,Sean %A Wierzba,Catherine %A Wolny,J %A Kaufman,Michelle R %+ Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of California, San Francisco, 550 16th Street, 4th Floor, San Francisco, CA, 94143, United States, 1 8054050772, alison.giovanelli@ucsf.edu %K digital mental health %K youth mentoring %K cognitive behavioral therapy %K teenager %K adolescent %K mobile phone %D 2023 %7 4.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Demand for adolescent mental health services has surged in the aftermath of the COVID-19 pandemic, and traditional models of care entailing in-person services with licensed mental health providers are inadequate to meet demand. However, research has shown that with proper training and supervision mentors can work with youth with mental health challenges like depression and anxiety and can even support the use of evidence-based strategies like cognitive behavioral therapy (CBT). In our increasingly connected world, youth mentors can meet with young people on a web-based platform at their convenience, reducing barriers to care. Moreover, the internet has made evidence-based CBT skills for addressing depression and anxiety more accessible than ever. As such, when trained and supervised by licensed clinicians, mentors are an untapped resource to support youth with mental health challenges. Objective: The objective of this study was to develop and assess the feasibility and acceptability of Appa Health (Appa), an evidence-based mental health mentoring program for youth experiencing symptoms of depression and anxiety. This paper describes the development, pilot testing process, and preliminary quantitative and qualitative outcomes of Appa’s 12-week smartphone app program which combines web-based near-peer mentorship with short-form TikTok-style videos teaching CBT skills created by licensed mental health professionals who are also social media influencers. Methods: The development and testing processes were executed through collaboration with key stakeholders, including young people and clinical and research advisory boards. In the pilot study, young people were assessed for symptoms of depression or anxiety using standard self-report clinical measures: the Patient Health Questionnaire-8 and the Generalized Anxiety Disorder-7 scales. Teenagers endorsing symptoms of depression or anxiety (n=14) were paired with a mentor (n=10) based on preferred characteristics such as gender, race or ethnicity, and lesbian, gay, bisexual, transgender, queer (LGBTQ) status. Quantitative survey data about the teenagers’ characteristics, mental health, and feasibility and acceptability were combined with qualitative data assessing youth perspectives on the program, their mentors, and the CBT content. Results: Participants reported finding Appa helpful, with 100% (n=14) of teenagers expressing that they felt better after the 12-week program. Over 85% (n=12) said they would strongly recommend the program to a friend. The teenagers were engaged, video chatting with mentors consistently over the 12 weeks. Metrics of anxiety and depressive symptoms reduced consistently from week 1 to week 12, supporting qualitative data suggesting that mentoring combined with CBT strategies has the potential to positively impact youth mental health and warrants further study. Conclusions: Appa Health is a novel smartphone app aiming to improve the well-being of youth and reduce anxiety and depressive symptoms through web-based mentoring and engaging CBT video content. This formative research sets the stage for a large-scale randomized controlled trial recently funded by the National Institutes of Health Small Business Innovation Research program. %M 37792468 %R 10.2196/49998 %U https://formative.jmir.org/2023/1/e49998 %U https://doi.org/10.2196/49998 %U http://www.ncbi.nlm.nih.gov/pubmed/37792468 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46951 %T Digital Storytelling Intervention to Promote Human Papillomavirus Vaccination Among At-Risk Asian Immigrant Populations: Pilot Intervention Study %A Chen,Angela Chia-Chen %A Kim,Sunny Wonsun %A Ou,Lihong %A Todd,Michael %A Larkey,Linda %+ College of Nursing, Michigan State University, 1355 Bogue Street, East Lansing, MI, 48824, United States, 1 5173555148, chenang6@msu.edu %K digital storytelling %K human papillomavirus %K immigrants %K Korean %K Vietnamese %K vaccination %D 2023 %7 4.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The high morbidity, mortality, and economic burden attributed to cancer-causing human papillomavirus (HPV) calls for researchers to address this public health concern through HPV vaccination. Despite disparities in HPV-associated cancers in Korean Americans and Vietnamese Americans, their vaccination rates remain low. Evidence points to the importance of developing culturally and linguistically congruent interventions to improve HPV vaccination rates. Digital storytelling (a specific form of cultural narrative) shows promise as an effective culture-centric health promotion strategy. Objective: The aim of this quasi-experimental single-group study was to assess the feasibility, acceptability, and preliminary effects of a culturally and linguistically congruent digital storytelling intervention on Korean American and Vietnamese American mothers’ attitudes and intention in vaccinating their children against HPV. We also examined if the association between attitudes and intention differed by their child’s sex (boy vs girl) and by ethnicity (Korean American vs Vietnamese American). Methods: Participants were recruited via multiple avenues (eg, ethnic minority community organizations, social media, and flyers posted in local Asian supermarkets and nail salons). Web-based, valid, and reliable measures were administered to collect data preintervention and postintervention. Descriptive statistics, paired and independent sample t tests, the chi-square test, and the McNemar test were used to describe the distributions of variables and to examine the differences between subgroups and changes in key variables over time. Logistic regression models were used to examine associations of mothers’ HPV- and vaccine-related attitudes with vaccination intention and to explore if the association between attitudes and vaccination intention differed by the target children’s sex or ethnicity. Results: In our sample of 50 Korean American mothers (mean age 42.8, SD 4.8 years) and 114 Vietnamese American mothers (mean age 41.5, SD 5.4 years), 36% (18/50) of Korean American and 51% (58/114) of Vietnamese American mothers reported that their children received free or reduced-price lunches at school. After the intervention, mothers’ attitudes toward HPV and the vaccine (t163=2.49, P=.01) and intention to vaccinate their children improved significantly (X21=18.38, P<.001). The measure of mothers’ negative attitudes toward HPV and the vaccine was significantly associated with higher vaccination intention (odds ratio 0.27, 95% CI 0.14-0.51; P<.001), adjusting for background variables (sociodemographic characteristics) and other HPV-related variables (family cancer history, prior HPV education, and HPV communication with health care providers). Findings did not suggest that a child’s sex or ethnicity moderated the association between attitudes and vaccination intention. Conclusions: This remotely delivered intervention using digital stories was feasible and acceptable, and showed preliminary effects on promoting Korean American and Vietnamese American mothers’ intention to vaccinate their children against HPV. Future research that uses a randomized controlled trial design with a larger and more diverse sample and includes children’s vaccination status will help understand the effect of the intervention. %M 36877658 %R 10.2196/46951 %U https://formative.jmir.org/2023/1/e46951 %U https://doi.org/10.2196/46951 %U http://www.ncbi.nlm.nih.gov/pubmed/36877658 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46757 %T Development and Implementation of DIALOG+S in the School Setting as a Tool for Promoting Adolescent Mental Well-Being and Resilience in a Post–Armed Conflict Area in Colombia: Exploratory Cluster Randomized Controlled Trial %A Gómez-Restrepo,Carlos %A Sarmiento-Suárez,María José %A Alba-Saavedra,Magda %A Calvo-Valderrama,Maria Gabriela %A Rincón-Rodríguez,Carlos Javier %A Bird,Victoria Jane %A Priebe,Stefan %A van Loggerenberg,Francois %+ Youth Resilience Unit, Centre for Psychiatry and Mental Health, Wolfson Institute of Population Health, Queen Mary University of London, Academic Centre, Newham Centre for Mental Health, Cherry Tree Way, London, E13 8SP, United Kingdom, 44 02075404210, f.vanloggerenberg@qmul.ac.uk %K mental health %K digital intervention %K psychosocial intervention %K armed conflict %K adolescents %K school %K DIALOG+ %K DIALOG+S %K mobile phone %D 2023 %7 4.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Educational settings are ideal for promoting mental well-being and resilience in children. The challenges of the COVID-19 pandemic made evident the important role that teachers and school counselors play in the mental health of their students. Therefore, it is imperative to develop and implement cost-effective interventions that allow them to identify and address mental health problems early, especially in post–armed conflict areas, to reduce the burden of mental disorders in this population. Objective: This study aimed to adapt an existing patient-focused digital intervention called DIALOG+ from an adult clinical setting to an adolescent educational setting and to assess the feasibility, acceptability, and estimated effect of implementing this intervention as a tool for promoting quality of life, mental well-being, and resilience. Methods: We conducted an exploratory mixed methods study in 2 public schools in postconflict areas in Tolima, Colombia. This study was conducted in 3 phases. In the adaptation phase, focus groups were conducted with students and teachers to identify changes required in DIALOG+ for it to be used in the school setting. The exploration phase consisted of an exploratory cluster randomized controlled trial. A total of 14 clusters, each with 1 teacher and 5 students, were randomly allocated to either the experimental (DIALOG+S) group or to an active control group (counseling as usual). Teachers in both groups delivered the intervention once a month for 6 months. Through screening scales, information was collected on mental health symptoms, quality of life, self-esteem, resilience, and family functionality before and after the intervention. Finally, the consolidation phase explored the experiences of teachers and students with DIALOG+S using focus group discussions. Results: The changes suggested by participants in the adaptation phase highlighted the central importance of the school setting in the mental health of adolescents. In the exploratory phase, 70 participants with a mean age of 14.69 (SD 2.13) years were included. Changes observed in the screening scale scores of the intervention group suggest that the DIALOG+S intervention has the potential to improve aspects of mental health, especially quality of life, resilience, and emotional symptoms. The consolidation phase showed that stakeholders felt that using this intervention in the school setting was feasible, acceptable, and an enriching experience that generated changes in the perceived mental health and behavior of participants. Conclusions: Our results are encouraging and show that the DIALOG+S intervention is feasible and acceptable as a promising opportunity to promote well-being and prevent and identify mental health problems in the school context in a postconflict area in Colombia. Larger, fully powered studies are warranted to properly assess the efficacy and potential impact of the intervention and to refine implementation plans. Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN) registry ISRCTN14396374; https://www.isrctn.com/ISRCTN14396374 International Registered Report Identifier (IRRID): RR2-10.2196/40286 %M 37792465 %R 10.2196/46757 %U https://formative.jmir.org/2023/1/e46757 %U https://doi.org/10.2196/46757 %U http://www.ncbi.nlm.nih.gov/pubmed/37792465 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e49678 %T Mobile and Web-Based Partnered Intervention to Improve Remote Access to Pain and Posttraumatic Stress Disorder Symptom Management: Recruitment and Attrition in a Randomized Controlled Trial %A Haun,Jolie N %A Venkatachalam,Hari H %A Fowler,Christopher A %A Alman,Amy C %A Ballistrea,Lisa M %A Schneider,Tali %A Benzinger,Rachel C %A Melillo,Christine %A Alexander,Neil B %A Klanchar,S Angelina %A Lapcevic,William %A French,Dustin D %+ James A. Haley Veterans' Hospital, Research Service, 8900 Grand Oak Circle, Tampa, FL, 33637, United States, 1 8135587622, rachel.benzinger@VA.Gov %K PTSD %K pain %K veteran %K attrition %K CIH %K randomized controlled trial %K chronic pain %K remote intervention %K dyad %K mobile health %D 2023 %7 3.10.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Increasing access to nonpharmacological interventions to manage pain and posttraumatic stress disorder (PTSD) is essential for veterans. Complementary and integrative health (CIH) interventions can help individuals manage symptom burden with enhanced accessibility via remotely delivered health care. Mission Reconnect (MR) is a partnered, self-directed intervention that remotely teaches CIH skills. Objective: The purpose of this paper is to describe the recruitment, onboarding phase, and attrition of a fully remote randomized controlled trial (RCT) assessing the efficacy of a self-directed mobile and web-based intervention for veterans with comorbid chronic pain and PTSD and their partners. Methods: A total of 364 veteran-partner dyads were recruited to participate in a mixed methods multisite waitlist control RCT. Qualitative attrition interviews were conducted with 10 veterans with chronic pain and PTSD, and their self-elected partners (eg, spouse) who consented but did not begin the program. Results: At the point of completing onboarding and being randomized to the 2 treatment arms, of the 364 recruited dyads, 97 (26.6%) failed to complete onboarding activities. Reported reasons for failure to complete onboarding include loss of self-elected partner buy-in (n=8, 8%), difficulties with using remote data collection methods and interventions (n=30, 31%), and adverse health experiences unrelated to study activities (n=23, 24%). Enrolled veterans presented at baseline with significant PTSD symptom burden and moderate-to-severe pain severity, and represented a geographically and demographically diverse population. Attrition interviews (n=10) indicated that misunderstanding MR including the intent of the intervention or mistaking the surveys as the actual intervention was a reason for not completing the MR registration process. Another barrier to MR registration was that interviewees described the mailed study information and registration packets as too confusing and excessive. Competing personal circumstances including health concerns that required attention interfered with MR registration. Common reasons for attrition following successful MR registration included partner withdrawal, adverse health issues, and technological challenges relating to the MR and electronic data collection platform (Qualtrics). Participant recommendations for reducing attrition included switching to digital forms to reduce participant burden and increasing human interaction throughout the registration and baseline data collection processes. Conclusions: Challenges, solutions, and lessons learned for study recruitment and intervention delivery inform best practices of delivering remote self-directed CIH interventions when addressing the unique needs of this medically complex population. Successful recruitment and enrollment of veterans with chronic pain and PTSD, and their partners, to remote CIH programs and research studies requires future examination of demographic and symptom-associated access barriers. Accommodating the unique needs of this medically complex population is essential for improving the effectiveness of CIH programs. Disseminating lessons learned and improving access to remotely delivered research studies and CIH programs is paramount in the post–COVID-19 climate. Trial Registration: ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/ct2/show/NCT03593772 %M 37788078 %R 10.2196/49678 %U https://www.jmir.org/2023/1/e49678 %U https://doi.org/10.2196/49678 %U http://www.ncbi.nlm.nih.gov/pubmed/37788078 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e48229 %T Testing the Effect of a Smartphone App on Hospital Admissions and Sedentary Behavior in Cardiac Rehabilitation Participants: ToDo-CR Randomized Controlled Trial %A Patterson,Kacie %A Davey,Rachel %A Keegan,Richard %A Niyonsenga,Theo %A Mohanty,Itismita %A Bowen,Sarah %A Regan,Elizabeth %A Lander,Michelle %A van Berlo,Sander %A Freene,Nicole %+ Health Research Institute, Faculty of Health, University of Canberra, University Drive, Bruce, ACT, 2617, Australia, 61 2 6201 5550, Kacie.Patterson@canberra.edu.au %K mobile health %K secondary prevention %K cardiovascular disease %K sedentary behavior %K hospital admissions %K cost-effectiveness %K mobile phone %D 2023 %7 3.10.2023 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: People with coronary heart disease are at an increased risk of morbidity and mortality even if they attend cardiac rehabilitation. High sedentary behavior levels potentially contribute to this morbidity. Smartphone apps may be feasible to facilitate sedentary behavior reductions and lead to reduced health care use. Objective: We aimed to test the effect of a sedentary behavior change smartphone app (Vire app and ToDo-CR program) as an adjunct to cardiac rehabilitation on hospital admissions and emergency department (ED) presentations over 12 months. Methods: A multicenter, randomized controlled trial was conducted with 120 participants recruited from 3 cardiac rehabilitation programs. Participants were randomized 1:1 to cardiac rehabilitation plus the fully automated 6-month Vire app and ToDo-CR program (intervention) or usual care (control). The primary outcome was nonelective hospital admissions and ED presentations over 12 months. Secondary outcomes including accelerometer-measured sedentary behavior, BMI, waist circumference, and quality of life were recorded at baseline and 6 and 12 months. Logistic regression models were used to analyze the primary outcome, and linear mixed-effects models were used to analyze secondary outcomes. Data on intervention and hospital admission costs were collected, and the incremental cost-effectiveness ratios (ICERs) were calculated. Results: Participants were, on average, aged 62 (SD 10) years, and the majority were male (93/120, 77.5%). The intervention group were more likely to experience all-cause (odds ratio [OR] 1.54, 95% CI 0.58-4.10; P=.39) and cardiac-related (OR 3.26, 95% CI 0.84-12.55; P=.09) hospital admissions and ED presentations (OR 2.07, 95% CI 0.89-4.77; P=.09) than the control group. Despite this, cardiac-related hospital admission costs were lower in the intervention group over 12 months (Aus $252.40 vs Aus $859.38; P=.24; a currency exchange rate of Aus $1=US $0.69 is applicable). There were no significant between-group differences in sedentary behavior minutes per day over 12 months, although the intervention group completed 22 minutes less than the control group (95% CI −22.80 to 66.69; P=.33; Cohen d=0.21). The intervention group had a lower BMI (β=1.62; P=.05), waist circumference (β=5.81; P=.01), waist-to-hip ratio (β=.03, P=.03), and quality of life (β=3.30; P=.05) than the control group. The intervention was more effective but more costly in reducing sedentary behavior (ICER Aus $351.77) and anxiety (ICER Aus $10,987.71) at 12 months. The intervention was also more effective yet costly in increasing quality of life (ICER Aus $93,395.50) at 12 months. Conclusions: The Vire app and ToDo-CR program was not an outcome-effective or cost-effective solution to reduce all-cause hospital admissions or ED presentations in cardiac rehabilitation compared with usual care. Smartphone apps that target sedentary behavior alone may not be an effective solution for cardiac rehabilitation participants to reduce hospital admissions and sedentary behavior. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619001223123; https://australianclinicaltrials.gov.au/anzctr/trial/ACTRN12619001223123 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2020-040479 %M 37788043 %R 10.2196/48229 %U https://mhealth.jmir.org/2023/1/e48229 %U https://doi.org/10.2196/48229 %U http://www.ncbi.nlm.nih.gov/pubmed/37788043 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e42851 %T The Effectiveness of a Neurofeedback-Assisted Mindfulness Training Program Using a Mobile App on Stress Reduction in Employees: Randomized Controlled Trial %A Min,Beomjun %A Park,Heyeon %A Kim,Johanna Inhyang %A Lee,Sungmin %A Back,Soyoung %A Lee,Eunhwa %A Oh,Sohee %A Yun,Je-Yeon %A Kim,Bung-Nyun %A Kim,Yonghoon %A Hwang,JungHyun %A Lee,Sanghyop %A Kim,Jeong-Hyun %+ Department of Public Health Medical Services, Seoul National University Bundang Hospital, 82, Gumi-ro 173 beon-gil, Bundang-gu, Seongnam-si, 13620, Republic of Korea, 82 31 787 2025, retrial3@hanmail.net %K mindfulness %K neurofeedback %K stress %K resilience %K mobile app %K employee %D 2023 %7 3.10.2023 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mindfulness-based training programs have consistently shown efficacy in stress reduction. However, questions regarding the optimal duration and most effective delivery methods remain. Objective: This research explores a 4-week neurofeedback-assisted mindfulness training for employees via a mobile app. The study’s core query is whether incorporating neurofeedback can amplify the benefits on stress reduction and related metrics compared with conventional mindfulness training. Methods: A total of 92 full-time employees were randomized into 3 groups: group 1 received mobile mindfulness training with neurofeedback assistance (n=29, mean age 39.72 years); group 2 received mobile mindfulness training without neurofeedback (n=32, mean age 37.66 years); and group 3 were given self-learning paper materials on stress management during their first visit (n=31, mean age 38.65 years). The primary outcomes were perceived stress and resilience scales. The secondary outcomes were mindfulness awareness, emotional labor, occupational stress, insomnia, and depression. Heart rate variability and electroencephalography were measured for physiological outcomes. These measurements were collected at 3 different times, namely, at baseline, immediately after training, and at a 4-week follow-up. The generalized estimating equation model was used for data analysis. Results: The 4-week program showed significant stress reduction (Wald χ22=107.167, P<.001) and improvements in psychological indices including resilience, emotional labor, insomnia, and depression. A significant interaction was observed in resilience (time × group, Wald χ42=10.846, P=.02). The post hoc analysis showed a statistically significant difference between groups 1 (least squares mean [LSM] 21.62, SE 0.55) and 3 (LSM 19.90, SE 0.61) at the posttraining assessment (P=.008). Group 1 showed a significant improvement (P<.001) at the posttraining assessment, with continued improvements through the 1-month follow-up assessment period (LSM 21.55, SE 0.61). Physiological indices were analyzed only for data of 67 participants (22 in group 1, 22 in group 2, and 23 in group 3) due to the data quality. The relaxation index (ratio of alpha to high beta power) from the right electroencephalography channel showed a significant interaction (time × group, Wald χ22=6.947, P=.03), with group 1 revealing the highest improvement (LSM 0.43, SE 0.15) compared with groups 2 (LSM –0.11, SE 0.10) and 3 (LSM 0.12, SE 0.10) at the 1-month follow-up assessment. Conclusions: The study demonstrated that the neurofeedback-assisted group achieved superior outcomes in resilience and relaxation during the 4-week mobile mindfulness program. Further research with larger samples and long-term follow-up is warranted. Trial Registration: ClinicalTrials.gov NCT03787407; https://clinicaltrials.gov/ct2/show/NCT03787407 %M 37788060 %R 10.2196/42851 %U https://mhealth.jmir.org/2023/1/e42851 %U https://doi.org/10.2196/42851 %U http://www.ncbi.nlm.nih.gov/pubmed/37788060 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e50374 %T An mHealth Text Messaging Program Providing Symptom Detection Training and Psychoeducation to Improve Hypoglycemia Self-Management: Intervention Development Study %A Lin,Yu Kuei %A Aikens,James E %A de Zoysa,Nicole %A Hall,Diana %A Funnell,Martha %A Nwankwo,Robin %A Kloss,Kate %A DeJonckheere,Melissa J %A Pop-Busui,Rodica %A Piatt,Gretchen A %A Amiel,Stephanie A %A Piette,John D %+ Department of Internal Medicine, University of Michigan, 1000 Wall Street, Ann Arbor, MI, 48105, United States, 1 7342321573, yuklin@med.umich.edu %K behavioral intervention %K CGM %K continuous glucose monitor %K design %K develop %K development %K diabetes %K diabetic %K glucose %K hypoglycemia %K hypoglycemic %K messaging %K mHealth %K mobile health %K self-management %K SMS text message %K text message %K type 1 diabetes %K type 1 %K user-centered %D 2023 %7 3.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Hypoglycemia remains a challenge for roughly 25% of people with type 1 diabetes (T1D) despite using advanced technologies such as continuous glucose monitors (CGMs) or automated insulin delivery systems. Factors impacting hypoglycemia self-management behaviors (including reduced ability to detect hypoglycemia symptoms and unhelpful hypoglycemia beliefs) can lead to hypoglycemia development in people with T1D who use advanced diabetes technology. Objective: This study aims to develop a scalable, personalized mobile health (mHealth) behavioral intervention program to improve hypoglycemia self-management and ultimately reduce hypoglycemia in people with T1D who use advanced diabetes technology. Methods: We (a multidisciplinary team, including clinical and health psychologists, diabetes care and education specialists, endocrinologists, mHealth interventionists and computer engineers, qualitative researchers, and patient partners) jointly developed an mHealth text messaging hypoglycemia behavioral intervention program based on user-centered design principles. The following five iterative steps were taken: (1) conceptualization of hypoglycemia self-management processes and relevant interventions; (2) identification of text message themes and message content development; (3) message revision; (4) patient partner assessments for message readability, language acceptability, and trustworthiness; and (5) message finalization and integration with a CGM data–connected mHealth SMS text message delivery platform. An mHealth web-based SMS text message delivery platform that communicates with a CGM glucose information-sharing platform was also developed. Results: The mHealth SMS text messaging hypoglycemia behavioral intervention program HypoPals, directed by patients’ own CGM data, delivers personalized intervention messages to (1) improve hypoglycemia symptom detection and (2) elicit self-reflection, provide fact-based education, and suggest practical health behaviors to address unhelpful hypoglycemia beliefs and promote hypoglycemia self-management. The program is designed to message patients up to 4 times per day over a 10-week period. Conclusions: A rigorous conceptual framework, a multidisciplinary team (including patient partners), and behavior change techniques were incorporated to create a scalable, personalized mHealth SMS text messaging behavioral intervention. This program was systematically developed to improve hypoglycemia self-management in advanced diabetes technology users with T1D. A clinical trial is needed to evaluate the program’s efficacy for future clinical implementation. %M 37788058 %R 10.2196/50374 %U https://formative.jmir.org/2023/1/e50374 %U https://doi.org/10.2196/50374 %U http://www.ncbi.nlm.nih.gov/pubmed/37788058 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e48301 %T Acceptability and Usability of a Theory-Driven Intervention via Email to Promote Physical Activity in Women Who Are Overweight or Obese: Substudy Within a Randomized Controlled Trial %A Brunet,Jennifer %A Sharma,Sitara %A Price,Jenson %A Black,Melissa %+ School of Human Kinetics, University of Ottawa, 125 University Private, Montpetit Hall # 339, Ottawa, ON, K1N 6N5, Canada, 1 613 562 5800 ext 3068, jennifer.brunet@uottawa.ca %K behavior change %K motivation %K overweight %K obese %K physical activity %K women %K digital %K randomized trial %K mobile phone %D 2023 %7 3.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Insufficient physical activity (PA) and excess weight increase illness risk for women. Face-to-face interventions can increase PA levels; however, they are often inaccessible. With growing interest in digital interventions, a Self-Determination Theory (SDT)–driven intervention was developed and delivered via email to promote PA in women who were insufficiently active and overweight or obese. Objective: This substudy explores users’ perspectives about the acceptability and usability of the intervention, which was coupled with a wearable activity monitor and PA recommendations. Methods: A 3-arm, parallel group, randomized controlled trial (unblinded) was conducted in Ontario, Canada. Recruitment occurred from September 2018 to March 2019 via advertising through social media, web-based boards, and posters in publicly accessible areas. In total, 47 women with a BMI of ≥25 kg/m2 who were not meeting the Canadian PA guidelines were randomly assigned to 1 of 3 arms (arm 1: n=15, 32%; arm 2: n=16, 34%; arm 3: n=16, 34%). This substudy focused on the 15 participants allocated to the main intervention arm. Participants received an automated intervention consisting of (1) 6 weekly emails, (2) a Polar Electro Inc A300 activity monitor (with access to the Polar Flow website and companion smartphone app), and (3) a copy of the Canadian PA guidelines for adults. Emails were developed using SDT and designed to enhance autonomous motivation by fostering the psychological needs of competence, autonomy, and relatedness. Well-established motivational and behavior change techniques were embedded in the emails to promote needs satisfaction. After the intervention (ie, 7 weeks after randomization), participants were invited to complete a web-based acceptability and usability survey containing open-ended and closed-ended questions; responses were analyzed using descriptive and content analyses, respectively. Results: The analyses included data from 93% (14/15) of the women (age: mean 33.4, SD 7.5; range 24-44 years; BMI: mean 31.3, SD 5.8 kg/m2; range 25-40.5 kg/m2) who received the main intervention and completed the postintervention survey. Open-ended responses indicated that participants were generally satisfied with the intervention and appreciated that emails prompted self-reflection, kept them on track and accountable, provided informational support, and were nonpressuring. Furthermore, they suggested that the monitor was “enjoyable” and “helpful”; quantitative data corroborated this, as 71% (10/14) said that the monitor was “very valuable/absolutely valuable,” 71% (10/14) would “very probably/definitely” still use one, and 86% (12/14) wore it for ≥5 days per week for ≥8 hours per day and checked it “occasionally/frequently/very frequently.” Potential threats to acceptability included “long” and “text-heavy” emails; lack of personal contact; and cumbersome, unaesthetic monitors. Conclusions: Results suggest that this SDT-driven, email-delivered intervention may be an acceptable low-contact approach to promote PA in women who are overweight or obese and insufficiently active; however, improvements are warranted and studies ascertaining its effectiveness are needed. Trial Registration: ClinicalTrials.gov NCT03601663; http://clinicaltrials.gov/ct2/show/NCT03601663 International Registered Report Identifier (IRRID): RR2-10.1177/20552076221093134 %M 37788048 %R 10.2196/48301 %U https://formative.jmir.org/2023/1/e48301 %U https://doi.org/10.2196/48301 %U http://www.ncbi.nlm.nih.gov/pubmed/37788048 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46491 %T Implementing Technologies to Enhance Coordinated Specialty Care Framework: Implementation Outcomes From a Development and Usability Study %A Green,James B %A Rodriguez,Joey %A Keshavan,Matcheri %A Lizano,Paulo %A Torous,John %+ Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02215, United States, 1 508 397 0853, jgreen8@bidmc.harvard.edu %K psychosis %K digital health %K digital mental health %K coordinated specialty care %K digital navigator %K clinical high risk %K schizophrenia %K implementation science %K technology %K mobile phone %D 2023 %7 3.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Coordinated specialty care (CSC) has demonstrated efficacy in improving outcomes in individuals at clinical high risk for psychosis and individuals with first-episode psychosis. Given the limitations of scalability and staffing needs, the augmentation of services using digital mental health interventions (DMHIs) may be explored to help support CSC service delivery. Objective: In this study, we aimed to understand the methods to implement and support technology in routine CSC and offered insights from a quality improvement study assessing the implementation outcomes of DMHIs in CSC. Methods: Patients and clinicians including psychiatrists, therapists, and supported education and employment specialists from a clinical-high-risk-for-psychosis clinic (Center for Early Detection Assessment and Response to Risk [CEDAR]) and a first-episode–psychosis clinic (Advancing Services for Psychosis Integration and Recovery [ASPIRE]) participated in a quality improvement project exploring the feasibility of DMHIs following the Access, Alignment, Connection, Care, and Scalability framework to implement mindLAMP, a flexible and evidenced-based DMHI. Digital navigators were used at each site to assist clinicians and patients in implementing mindLAMP. To explore the differences in implementation outcomes associated with the app format, a menu-style format was delivered at CEDAR, and a modular approach was used at ASPIRE. Qualitative baseline and follow-up data were collected to assess the specific implementation outcomes. Results: In total, 5 patients (ASPIRE: n=3, 60%; CEDAR: n=2, 40%) were included: 3 (60%) White individuals, 2 (40%) male and 2 (40%) female patients, and 1 (20%) transgender man, with a mean age of 19.6 (SD 2.05) years. Implementation outcome data revealed that patients and clinicians demonstrated high accessibility, acceptability, interest, and belief in the sustainability of DMHIs. Clinicians and patients presented a wide range of interest in unique use cases of DMHI in CSC and expressed variable feasibility and appropriateness associated with nuanced barriers and needs. In addition, the results suggest that adoption, penetration, feasibility, and appropriateness outcomes were moderate and might continue to be explored and targeted. Conclusions: Implementation outcomes from this project suggest the need for a patient- and clinician-centered approach that is guided by digital navigators and provides versatility, autonomy, and structure. Leveraging these insights has the potential to build on growing research regarding the need for versatility, autonomy, digital navigator support, and structured applications. We anticipate that by continuing to research and improve implementation barriers impeding the adoption and penetration of DMHIs in CSC, accessibility and uptake of DMHIs will improve, therefore connecting patients to the demonstrated benefits of technology-augmented care. %M 37788066 %R 10.2196/46491 %U https://formative.jmir.org/2023/1/e46491 %U https://doi.org/10.2196/46491 %U http://www.ncbi.nlm.nih.gov/pubmed/37788066 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e36596 %T The Effect of a Digital Mental Health Program on Anxiety and Depression Symptoms: Retrospective Analysis of Clinical Severity %A Dzubur,Eldin %A Yu,Jessica %A Hoffman,Julia %A Painter,Stefanie %A James,Roberta %A Shah,Bimal %+ Teladoc Health, 2 Manhattanville Rd, Purchase, NY, 10577, United States, 1 3123307236, spainter@teladoc.com %K digital health %K mental health %K anxiety %K depression %K digital mental health %K program usage %D 2023 %7 3.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Evidence-based digital health programs have shown efficacy in being primary tools to improve emotional and mental health, as well as offering supplementary support to individuals undergoing psychotherapy for anxiety, depression, and other mental health disorders. However, information is lacking about the dose response to digital mental health interventions. Objective: The objective of the study was to examine the effect of time in program and program usage on symptom change among individuals enrolled in a real-world comprehensive digital mental health program (myStrength) who are experiencing severe anxiety or depression. Methods: Eligible participants (N=18,626) were adults aged 18 years and older who were enrolled in myStrength for at least four weeks as part of their employee wellness benefit program, who completed baseline, the 2-week, 2-month, and 6-month surveys querying symptoms of anxiety (Generalized Anxiety Disorder–7 [GAD-7]) and depression (Patient Health Questionnaire–9 [PHQ-9]). Linear growth curve models were used to analyze the effect of average weekly program usage on subsequent GAD-7 and PHQ-9 scores for participants with scores indicating severe anxiety (GAD-7≥15) or depression (PHQ-9≥15). All models were adjusted for baseline score and demographics. Results: Participants in the study (N=1519) were 77.4% female (1176/1519), had a mean age of 45 years (SD 14 years), and had an average enrollment time of 3 months. At baseline, participants reported an average of 9.39 (SD 6.04) on the GAD-7 and 11.0 (SD 6.6) on the PHQ-9. Those who reported 6-month results had an average of 8.18 (SD 6.15) on the GAD-7 and 9.18 (SD 6.79) on the PHQ-9. Participants with severe scores (n=506) experienced a significant improvement of 2.97 (SE 0.35) and 3.97 (SE 0.46) at each time point for anxiety and depression, respectively (t=–8.53 and t=–8.69, respectively; Ps<.001). Those with severe baseline scores also saw a reduction of 0.27 (SE 0.08) and 0.25 (SE 0.09) points in anxiety and depression, respectively, for each additional program activity per week (t=–3.47 and t=–2.66, respectively; Ps<.05). Conclusions: For participants with severe baseline scores, the study found a clinically significant reduction of approximately 9 points for anxiety and 12 points for depression after 6 months of enrollment, suggesting that interventions targeting mental health must maintain active, ongoing engagement when symptoms are present and be available as a continuous resource to maximize clinical impact, specifically in those experiencing severe anxiety or depression. Moreover, a dosing effect was shown, indicating improvement in outcomes among participants who engaged with the program every other day for both anxiety and depression. This suggests that digital mental health programs that provide both interesting and evidence-based activities could be more successful in further improving mental health outcomes. %M 37788069 %R 10.2196/36596 %U https://formative.jmir.org/2023/1/e36596 %U https://doi.org/10.2196/36596 %U http://www.ncbi.nlm.nih.gov/pubmed/37788069 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e51899 %T Optimizing a Technology-Based Body and Mind Intervention to Prevent Falls and Reduce Health Disparities in Low-Income Populations: Protocol for a Clustered Randomized Controlled Trial %A Thiamwong,Ladda %A Xie,Rui %A Park,Joon-Hyuk %A Lighthall,Nichole %A Loerzel,Victoria %A Stout,Jeffrey %+ Nursing Systems Department, College of Nursing, University of Central Florida, 12201 Research Parkway, Suite 300, Orlando, FL, 32826, United States, 1 4078232744, ladda.thiamwong@ucf.edu %K fall prevention %K fear of falling %K low income %K older adults %K exercise %K technology %D 2023 %7 3.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: The lack of health care coverage, low education, low motivation, and inconvenience remain barriers to participating in fall prevention programs, especially among low-income older adults. Low-income status also contributes to negative aging self-perceptions and is associated with a high perceived barrier to care. Existing fall prevention intervention technologies do not enable participants and practitioners to interact and collaborate, even with technologies that bring viable strategies to maintain independence, prevent disability, and increase access to quality care. Research is also limited on the use of technology to enhance motivation and help individuals align their perception with physiological fall risk. We developed a novel, 8-week Physio-Feedback Exercise Program (PEER), which includes (1) technology-based physio-feedback using a real-time portable innovative technology—the BTrackS Balance Tracking System, which is reliable and affordable, allows for home testing, and provides feedback and tracks balance progression; (2) cognitive reframing using the fall risk appraisal matrix; and (3) peer-led exercises focusing on balance, strength training, and incorporating exercises into daily activities. Objective: This study consists of 3 aims. Aim 1 is to examine the effects of the technology-based PEER intervention on fall risk, dynamic balance, and accelerometer-based physical activity (PA). Aim 2 is to examine the effects of the PEER intervention on fall risk appraisal shifting and negative self-perceptions of aging. Aim 3 is to explore participants’ experiences with the PEER intervention and potential barriers to accessing and adopting the technology-based PEER intervention to inform future research. Methods: This is an intention-to-treat, single-blinded, parallel, 2-arm clustered randomized controlled trial study. We will collect data from 340 low-income older adults at baseline (T1) and measure outcomes after program completion (T2) and follow-up at 3 months (T3) and 6 months (T4). Participants will be enrolled if they meet all the following inclusion criteria: aged ≥60 years, cognitively intact, and able to stand without assistance. Exclusion criteria were as follows: a medical condition precluding exercise or PA, currently receiving treatment from a rehabilitation facility, plan to move within 1 year, hospitalized >3 times in the past 12 months, and does not speak English or Spanish. Results: As of August 2023, the enrollment of participants is ongoing. Conclusions: This study addresses the public health problem by optimizing a customized, technology-driven approach that can operate in low-resource environments with unlimited users to prevent falls and reduce health disparities in low-income older adults. The PEER is a novel intervention that combines concepts of physio-feedback, cognitive reframing, and peer-led exercise by motivating a shift in self-estimation of fall risk to align with physiological fall risk to improve balance, PA, and negative aging self-perception. Trial Registration: ClinicalTrials.gov NCT05778604; https://www.clinicaltrials.gov/ct2/show/study/NCT05778604 International Registered Report Identifier (IRRID): DERR1-10.2196/51899 %M 37788049 %R 10.2196/51899 %U https://www.researchprotocols.org/2023/1/e51899 %U https://doi.org/10.2196/51899 %U http://www.ncbi.nlm.nih.gov/pubmed/37788049 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46082 %T Testing the Effects of App-Based Motivational Messages on Physical Activity and Resting Heart Rate Through Smartphone App Compliance in Patients With Vulnerable Coronary Artery Plaques: Protocol for a Microrandomized Trial %A Mitra,Sayan %A Kroeger,Cynthia M %A Xu,Jing %A Avery,Leah %A Masedunskas,Andrius %A Cassidy,Sophie %A Wang,Tian %A Hunyor,Imre %A Wilcox,Ian %A Huang,Robin %A Chakraborty,Bibhas %A Fontana,Luigi %+ Charles Perkins Centre, The University of Sydney, John Hopkins Drive, Camperdown, NSW 2006, Australia, 61 02 86275819, sayan.mitra@sydney.edu.au %K adherence %K coronary artery disease %K coronary heart disease %K digital health %K health behavior %K heart rate %K messages %K mhealth %K microrandomized trial %K mobile app %K physical activity %K smartphone %K telehealth %K user motivation %D 2023 %7 2.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Achieving the weekly physical activity recommendations of at least 150-300 minutes of moderate-intensity or 75-150 minutes of vigorous-intensity aerobic exercise is important for reducing cardiometabolic risk, but evidence shows that most people struggle to meet these goals, particularly in the mid to long term. Objective: The Messages Improving Resting Heart Health (MIRTH) study aims to determine if (1) sending daily motivational messages through a research app is effective in improving motivation and in promoting adherence to physical activity recommendations in men and women with coronary heart disease randomized to a 12-month intensive lifestyle intervention, and (2) the time of the day when the message is delivered impacts compliance with exercise training. Methods: We will conduct a single-center, microrandomized trial. Participants will be randomized daily to either receive or not receive motivational messages over two 90-day periods at the beginning (phase 1: months 4-6) and at the end (phase 2: months 10-12) of the Lifestyle Vulnerable Plaque Study. Wrist-worn devices (Fitbit Inspire 2) and Bluetooth pairing with smartphones will be used to passively collect data for proximal (ie, physical activity duration, steps walked, and heart rate within 180 minutes of receiving messages) and distal (ie, change values for resting heart rate and total steps walked within and across both phases 1 and 2 of the trial) outcomes. Participants will be recruited from a large academic cardiology office practice (Central Sydney Cardiology) and the Royal Prince Alfred Hospital Departments of Cardiology and Radiology. All clinical investigations will be undertaken at the Charles Perkins Centre Royal Prince Alfred clinic. Individuals aged 18-80 years (n=58) with stable coronary heart disease who have low attenuation plaques based on a coronary computed tomography angiography within the past 3 months and have been randomized to an intensive lifestyle intervention program will be included in MIRTH. Results: The Lifestyle Vulnerable Plaque Study was funded in 2020 and started enrolling participants in February 2022. Recruitment for MIRTH commenced in November 2022. As of September 2023, 2 participants were enrolled in the MIRTH study and provided baseline data. Conclusions: This MIRTH microrandomized trial will represent the single most detailed and integrated analysis of the effects of a comprehensive lifestyle intervention delivered through a customized mobile health app on smart devices on time-based motivational messaging for patients with coronary heart disease. This study will also help inform future studies optimizing for just-in-time adaptive interventions. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12622000731796; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382861 International Registered Report Identifier (IRRID): DERR1-10.2196/46082 %M 37782531 %R 10.2196/46082 %U https://www.researchprotocols.org/2023/1/e46082 %U https://doi.org/10.2196/46082 %U http://www.ncbi.nlm.nih.gov/pubmed/37782531 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46989 %T Effectiveness of a Mobile App Intervention for Preparing Preschool Children and Parents for Day Surgery: Randomized Controlled Trial %A Kerimaa,Heli %A Hakala,Mervi %A Haapea,Marianne %A Vähänikkilä,Hannu %A Serlo,Willy %A He,Hong-Gu %A Pölkki,Tarja %+ Research Unit of Health Sciences and Technology, University of Oulu, Aapistie 5A, Oulu, 90220, Finland, 358 294485602, heli.kerimaa@oulu.fi %K anxiety %K day surgery %K fear %K mobile app %K pain %K parents %K preparation %K preschool child %K randomized controlled trial %K stress %K mobile phone %D 2023 %7 29.9.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Day surgery allows families to return home quickly. Only a few approaches to preparing for day surgery have demonstrated how digital solutions can support families and children. Objective: This study aims to evaluate the effectiveness of a mobile app intervention on preschool children’s fear and pain and parents’ anxiety and stress in preparing children for day surgery. Methods: This study was conducted at the Pediatric Day Surgical Department of a university hospital in Finland between 2018 and 2020. Parents of children (aged 2-6 y) who were in a queue for elective day surgery were randomized into the intervention group (IG; n=36) and control group (CG; n=34). The CG received routine preparations, whereas the IG was prepared using a mobile app. Parents’ and children’s outcomes were measured using validated scales at 4 different points: at home (T1 and T4) and at the hospital (T2 and T3) before and after surgery. Group differences were analyzed using statistical methods suitable for the material. Results: Before surgery, parents in both groups experienced mild anxiety, which decreased after surgery. Parental anxiety did not differ between groups preoperatively (P=.78) or postoperatively (P=.63). Both groups had less anxiety at home after surgery compared with before. The IG showed a significant decrease (P=.003); the CG also improved (P=.002). Preoperatively at home, most parents in both groups experienced no stress or mild stress (P=.61). Preoperatively at the hospital, parents in both groups experienced mild stress; however, parents in the IG experienced more stress during this phase (P=.02). Parents in the IG experienced significantly less stress postoperatively than those in the CG (P=.05). Both groups showed decreased stress levels from before to after surgery (IG: P=.003; CG: P=.004) within each group. There were no significant differences in children’s pain levels between the groups and measurement points. This was observed before surgery at home (P=.25), before surgery at the hospital (P=.98), and after surgery at the hospital (P=.72). Children’s fear decreased more in the IG (P=.006) than in the CG (P=.44) comparing the phases before and after surgery at home. Fear did not differ between the IG and CG preoperatively at home (P=.20) or at the hospital (P=.59) or postoperatively at the hospital (P=.62) or at home (P=.81). Conclusions: The mobile app intervention did not reduce anxiety or pain. However, it was observed that parents in the IG experienced substantially heightened stress levels before surgery at the hospital, which decreased significantly after surgery at home. In addition, fear levels in children in the IG decreased over time, whereas no significant change was observed in the CG. These results are important for developing health care service chains and providing families with innovative and customer-oriented preparation methods. Trial Registration: ClinicalTrials.gov NCT03774303; https://classic.clinicaltrials.gov/ct2/show/NCT03774303 %M 37773624 %R 10.2196/46989 %U https://www.jmir.org/2023/1/e46989 %U https://doi.org/10.2196/46989 %U http://www.ncbi.nlm.nih.gov/pubmed/37773624 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 8 %N %P e42100 %T Assessing the Content Validity, Acceptability, and Feasibility of the Hypo-METRICS App: Survey and Interview Study %A Søholm,Uffe %A Zaremba,Natalie %A Broadley,Melanie %A Axelsen,Johanne Lundager %A Divilly,Patrick %A Martine-Edith,Gilberte %A Amiel,Stephanie A %A Mader,Julia K %A Pedersen-Bjergaard,Ulrik %A McCrimmon,Rory J %A Renard,Eric %A Evans,Mark %A de Galan,Bastiaan %A Heller,Simon %A Hendrieckx,Christel %A Choudhary,Pratik %A Speight,Jane %A Pouwer,Frans %A , %+ Medical & Science, Patient Focused Drug Development, Novo Nordisk A/S, Vandtårnsvej 114, Søborg, 2860, Denmark, 45 34481435, uffehs@gmail.com %K hypoglycemia %K diabetes %K ecological momentary assessment %K smartphone app %K content validity %K mobile phone %D 2023 %7 29.9.2023 %9 Original Paper %J JMIR Diabetes %G English %X Background: The Hypoglycaemia – MEasurement, ThResholds and ImpaCtS (Hypo-METRICS) smartphone app was developed to investigate the impact of hypoglycemia on daily functioning in adults with type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus. The app uses ecological momentary assessments, thereby minimizing recall bias and maximizing ecological validity. It was used in the Hypo-METRICS study, a European multicenter observational study wherein participants wore a blinded continuous glucose monitoring device and completed the app assessments 3 times daily for 70 days. Objective: The 3 aims of the study were to explore the content validity of the app, the acceptability and feasibility of using the app for the duration of the Hypo-METRICS study, and suggestions for future versions of the app. Methods: Participants who had completed the 70-day Hypo-METRICS study in the United Kingdom were invited to participate in a brief web-based survey and an interview (approximately 1h) to explore their experiences with the app during the Hypo-METRICS study. Thematic analysis of the qualitative data was conducted using both deductive and inductive methods. Results: A total of 18 adults with diabetes (type 1 diabetes: n=10, 56%; 5/10, 50% female; mean age 47, SD 16 years; type 2 diabetes: n=8, 44%; 2/8, 25% female; mean age 61, SD 9 years) filled out the survey and were interviewed. In exploring content validity, participants overall described the Hypo-METRICS app as relevant, understandable, and comprehensive. In total, 3 themes were derived: hypoglycemia symptoms and experiences are idiosyncratic; it was easy to select ratings on the app, but day-to-day changes were perceived as minimal; and instructions could be improved. Participants offered suggestions for changes or additional questions and functions that could increase engagement and improve content (such as providing more examples with the questions). In exploring acceptability and feasibility, 5 themes were derived: helping science and people with diabetes; easy to fit in, but more flexibility wanted; hypoglycemia delaying responses and increasing completion time; design, functionality, and customizability of the app; and limited change in awareness of symptoms and impact. Participants described using the app as a positive experience overall and as having a possible, although limited, intervention effect in terms of both hypoglycemia awareness and personal impact. Conclusions: The Hypo-METRICS app shows promise as a new research tool to assess the impact of hypoglycemia on an individual’s daily functioning. Despite suggested improvements, participants’ responses indicated that the app has satisfactory content validity, overall fits in with everyday life, and is suitable for a 10-week research study. Although developed for research purposes, real-time assessments may have clinical value for monitoring and reviewing hypoglycemia symptom awareness and personal impact. %M 37773626 %R 10.2196/42100 %U https://diabetes.jmir.org/2023/1/e42100 %U https://doi.org/10.2196/42100 %U http://www.ncbi.nlm.nih.gov/pubmed/37773626 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48177 %T A Suicide Prevention Intervention for Emerging Adult Sexual and Gender Minority Groups: Protocol for a Pilot Hybrid Effectiveness Randomized Controlled Trial %A Brown,Lily A %A Webster,Jessica L %A Tran,Jennifer T %A Wolfe,James R %A Golinkoff,Jesse %A Patel,Esha %A Arcomano,Amanda C %A Ben Nathan,Jennifer %A Azat O'Connor,Alexander %A Zhu,Yiqin %A Oquendo,Maria %A Brown,Gregory K %A Mandell,David %A Mowery,Danielle %A Bauermeister,José A %+ Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street Suite 600 N, Philadelphia, PA, 19147, United States, 1 215 746 3346, lilybr@upenn.edu %K lesbian, gay, bisexual, transgender, queer, plus %K LGBTQ+ health %K suicide %K peer navigator %K emerging adults %K life skills %K mobile phone %D 2023 %7 29.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Suicide attempts and suicide death disproportionately affect sexual and gender minority emerging adults (age 18-24 years). However, suicide prevention strategies tailored for emerging adult sexual and gender minority (EA-SGM) groups are not widely available. The Safety Planning Intervention (SPI) has strong evidence for reducing the risk for suicide in the general population, but it is unclear how best to support EA-SGM groups in their use of a safety plan. Our intervention (Supporting Transitions to Adulthood and Reducing Suicide [STARS]) builds on content from an existing life skills mobile app for adolescent men who have sex with men (iREACH) and seeks to target core risk factors for suicide among EA-SGM groups, namely, positive affect, discrimination, and social disconnection. The mobile app is delivered to participants randomized to STARS alongside 6 peer mentoring sessions to support the use of the safety plan and other life skills from the app to ultimately reduce suicide risk. Objective: We will pilot-test the combination of peer mentoring alongside an app-based intervention (STARS) designed to reduce suicidal ideation and behaviors. STARS will include suicide prevention content and will target positive affect, discrimination, and social support. After an in-person SPI with a clinician, STARS users can access content and activities to increase their intention to use SPI and overcome obstacles to its use. EA-SGM groups will be randomized to receive either SPI alone or STARS and will be assessed for 6 months. Methods: Guided by the RE-AIM (reach, efficacy, adoption, implementation, and maintenance) framework, we will recruit and enroll a racially and ethnically diverse sample of 60 EA-SGM individuals reporting past-month suicidal ideation. Using a type-1 effectiveness-implementation hybrid design, participants will be randomized to receive SPI (control arm) or to receive SPI alongside STARS (intervention arm). We will follow the participants for 6 months, with evaluations at 2, 4, and 6 months. Preliminary effectiveness outcomes (suicidal ideation and behavior) and hypothesized mechanisms of change (positive affect, coping with discrimination, and social support) will serve as our primary outcomes. Secondary outcomes include key implementation indicators, including participants’ willingness and adoption of SPI and STARS and staff’s experiences with delivering the program. Results: Study activities began in September 2021 and are ongoing. The study was approved by the institutional review board of the University of Pennsylvania (protocol number 849500). Study recruitment began on October 14, 2022. Conclusions: This project will be among the first tailored, mobile-based interventions for EA-SGM groups at risk for suicide. This project is responsive to the documented gaps for this population: approaches that address chosen family, focus on a life-course perspective, web approaches, and focus on health equity and provision of additional services relevant to sexual and gender minority youth. Trial Registration: ClinicalTrials.gov NCT05018143; https://classic.clinicaltrials.gov/ct2/show/NCT05018143 International Registered Report Identifier (IRRID): DERR1-10.2196/48177 %M 37773618 %R 10.2196/48177 %U https://www.researchprotocols.org/2023/1/e48177 %U https://doi.org/10.2196/48177 %U http://www.ncbi.nlm.nih.gov/pubmed/37773618 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44220 %T Experiences of Using Digital Mindfulness-Based Interventions: Rapid Scoping Review and Thematic Synthesis %A Osborne,Emma Louise %A Ainsworth,Ben %A Hooper,Nic %A Atkinson,Melissa Jayne %+ Department of Psychology, University of Bath, 10 West, Claverton Down, Bath, BA2 7AY, United Kingdom, 44 383843 ext 01225, elo25@bath.ac.uk %K mindfulness %K digital intervention %K dropout %K eHealth %K engagement %K mobile health %K mHealth %K psychosocial intervention %K qualitative research %K scoping review %K thematic synthesis %K mobile phone %D 2023 %7 28.9.2023 %9 Review %J J Med Internet Res %G English %X Background: Digital mindfulness-based interventions (MBIs) are a promising approach to deliver accessible and scalable mindfulness training and have been shown to improve a range of health outcomes. However, the success of digital MBIs is reliant on adequate engagement, which remains a crucial challenge. Understanding people’s experiences of using digital MBIs and identifying the core factors that facilitate or act as barriers to engagement is essential to inform intervention development and maximize engagement and outcomes. Objective: This study aims to systematically map the literature on people’s experiences of using digital MBIs that target psychosocial variables (eg, anxiety, depression, distress, and well-being) and identify key barriers to and facilitators of engagement. Methods: We conducted a scoping review to synthesize empirical qualitative research on people’s experiences of using digital MBIs. We adopted a streamlined approach to ensure that the evidence could be incorporated into the early stages of intervention development. The search strategy identified articles with at least one keyword related to mindfulness, digital, user experience, and psychosocial variables in their title or abstract. Inclusion criteria specified that articles must have a qualitative component, report on participants’ experiences of using a digital MBI designed to improve psychosocial variables, and have a sample age range that at least partially overlapped with 16 to 35 years. Qualitative data on user experience were charted and analyzed using inductive thematic synthesis to generate understandings that go beyond the content of the original studies. We used the Quality of Reporting Tool to critically appraise the included sources of evidence. Results: The search identified 530 studies, 22 (4.2%) of which met the inclusion criteria. Overall, the samples were approximately 78% female and 79% White; participants were aged between 16 and 69 years; and the most used measures in intervention studies were mindfulness, psychological flexibility, and variables related to mental health (including depression, anxiety, stress, and well-being). All studies were judged to be adequately reported. We identified 3 themes characterizing barriers to and facilitators of engagement: responses to own practice (ie, negative reactions to one’s own practice are common and can deplete motivation), making mindfulness a habit (ie, creating a consistent training routine is essential yet challenging), and leaning on others (ie, those engaging depend on someone else for support). Conclusions: The themes identified in this review provide crucial insights as to why people frequently stop engaging with digital MBIs. Researchers and developers should consider using person-based coparticipatory methods to improve acceptability of and engagement with digital MBIs, increase their effectiveness, and support their translation to real-world use. Such strategies must be grounded in relevant literature and meet the priorities and needs of the individuals who will use the interventions. %M 37768709 %R 10.2196/44220 %U https://www.jmir.org/2023/1/e44220 %U https://doi.org/10.2196/44220 %U http://www.ncbi.nlm.nih.gov/pubmed/37768709 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e46878 %T Acceptability of the eHealth Intervention Sustainable Worker Digital Support for Persons With Chronic Pain and Their Employers (SWEPPE): Questionnaire and Interview Study %A Svanholm,Frida %A Turesson,Christina %A Löfgren,Monika %A Björk,Mathilda %+ Pain and Rehabilitation Centre, Department of Health, Medicine and Caring Sciences, Linköping University, Brigadgatan 22, Linköping, s-58185, Sweden, 46 730 447785, frida.svanholm@liu.se %K chronic pain %K digital support %K eHealth %K return to work %K rehabilitation %K support %K quality of life %K implementation %K acceptability %K interview %K questionnaire %K qualitative %K barrier %K users %K mobile phone %D 2023 %7 28.9.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Sick leave and decreased ability to work are the consequences of chronic pain. Interdisciplinary pain rehabilitation programs (IPRPs) aim to improve health-related quality of life and participation in work activities, although implementing rehabilitation strategies at work after IPRPs can be difficult. Employers’ knowledge about pain and the role of rehabilitation needs to be strengthened. The self-management of chronic pain can be improved through eHealth interventions. However, these interventions do not involve communicating with employers to improve work participation. To address this deficiency, a new eHealth intervention, Sustainable Worker Digital Support for Persons with Chronic Pain and Their Employers (SWEPPE), was developed. Objective: This study aimed to describe the acceptability of SWEPPE after IPRPs from the perspective of patients with chronic pain and their employers. Methods: This study included 11 patients and 4 employers who were recruited to test SWEPPE in daily life for 3 months after IPRPs. Data were collected using individual interviews at the end of the 3-month test period and questionnaires, which were completed when SWEPPE was introduced (questionnaire 1) and at a 3-month follow-up (questionnaire 2). Data were also collected on how often SWEPPE was used. Qualitative data were analyzed through a qualitative content analysis using an abductive approach. The framework used for the deductive approach was the theoretical framework of acceptability. Quantitative data were analyzed through descriptive statistics and the differences between the responses to questionnaires 1 and questionnaire 2 using the Wilcoxon signed rank test. Results: Both patients and employers reported that SWEPPE increased their knowledge and understanding of how to improve work participation and helped them identify goals, barriers, and strategies for return to work. In addition, participants noted that SWEPPE improved employer-employee communication and collaboration. However, experiences and ratings varied among participants and the different SWEPPE modules. The acceptability of SWEPPE was lower in patients who experienced significant pain and fatigue. A high degree of flexibility and choice of ratings in SWEPPE were generally described as helpful. Conclusions: This study shows promising results on the user acceptability of SWEPPE from both patient and employer perspectives. However, the variations among patients and modules indicate a need for further testing and research to refine the content and identify the group of patients who will best benefit from SWEPPE. %M 37768708 %R 10.2196/46878 %U https://humanfactors.jmir.org/2023/1/e46878 %U https://doi.org/10.2196/46878 %U http://www.ncbi.nlm.nih.gov/pubmed/37768708 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48585 %T mHealth Intervention for Vietnamese Living With Diabetes: Protocol for a Stepped Wedge Pilot Study %A Nguyen,Anna %A Nagykaldi,Zsolt %A Bui,Thanh %A Chen,Sixia %A Businelle,Michael %A Eschiti,Valerie %A Dwyer,Kathleen %+ Fran and Earl Ziegler College of Nursing, University of Oklahoma Health Sciences Center, 1100 N Stonewall Avenue, Suite 412, Oklahoma City, OK, 73117, United States, 1 4052711491, anna-nguyen@ouhsc.edu %K Vietnamese %K type 2 diabetes %K diabetes self-management %K mobile health technology %K intervention study %K stepped wedge design %K mobile health %K intervention %K mobile app %K digital health %K diabetes %K self-management %K awareness %K mhealth %K implementation %D 2023 %7 28.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Evidence indicates participation in a diabetes self-management education and support program improves self-care behaviors and hemoglobin A1c. Language and cultural differences may be barriers to program participation resulting in ineffective self-management, but these factors can be addressed with appropriate interventions. Given the high health care costs associated with diabetes complications, we developed a multicomponent, culturally tailored Self-Management Mobile Health Intervention for US Vietnamese With Diabetes (SMart-D). Objective: This study aims to evaluate the SMart-D intervention’s feasibility, acceptability, and effectiveness with intentions to scale up the intervention in the future. This mixed methods study incorporates the Reach, Effectiveness, Adoption, Implementation, Maintenance framework to evaluate the intervention. Methods: This stepped wedge randomized controlled pilot study will be conducted over 2 years in collaboration with primary care clinics. Eligible participants are patients with type 2 diabetes who are receiving health care from participating clinics. Clinics will be randomly assigned to an implementation date and will begin with patients enrolling in the control period while receiving standard care, then cross over to the intervention period where patients receive standard care plus the SMart-D intervention for over 12 weeks. Focus groups or interviews will be conducted with clinicians and patients after study completion. Qualitative data will be analyzed using NVivo. Outcomes on self-care behavior changes will be measured with the Summary of Diabetes Self-Care Activities scale and clinical changes will be measured using laboratory tests. A generalized linear mixed-effect model will be used to compute time effect, clustering effect, and the interaction of the control and intervention periods using SAS (version 9.4; SAS Institute). Results: We hypothesize that (1) at least 50% (n=5) of eligible clinics and 50% (n=40) of eligible patients who are invited will participate, and at least 70% (n=56) of patients will complete the program, and (2) patients who receive the intervention will have improved self-care behaviors and clinical test results with at least 75% (n=60) of the patients maintaining improved outcomes at follow-up visits compared with baseline, and participants will verbalize that the intervention is feasible and acceptable. As of August 2023, we enrolled 10 clinics and 60 patients. Baseline data results will be available by the end of 2023 and outcome data will be published in 2025. Conclusions: This is the first Vietnamese diabetes self-management education and support intervention that leverages mobile health technology to address the barriers of language and culture differences through collaboration with primary care clinics. This study will provide a better understanding of the implementation process, demonstrate the potential effectiveness of the intervention, accelerate the pace of moving evidence-based interventions to practice among the US Vietnamese population, and potentially provide a replicable implementation model that can be culturally adapted to other non-English speaking ethnic minorities. International Registered Report Identifier (IRRID): DERR1-10.2196/48585 %M 37768716 %R 10.2196/48585 %U https://www.researchprotocols.org/2023/1/e48585 %U https://doi.org/10.2196/48585 %U http://www.ncbi.nlm.nih.gov/pubmed/37768716 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47319 %T Addressing the Chronic Pain–Early Cognitive Decline Comorbidity Among Older Adults: Protocol for the Active Brains Remote Efficacy Trial %A Vranceanu,Ana-Maria %A Choukas,Nathaniel R %A Rochon,Elizabeth A %A Duarte,Brooke %A Pietrzykowski,Malvina O %A McDermott,Katherine %A Hooker,Julia E %A Kulich,Ronald %A Quiroz,Yakeel T %A Parker,Robert A %A Macklin,Eric A %A Ritchie,Christine %A , %A Mace,Ryan A %+ Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, 1 Bowdoin Square, Suite 100, Boston, MA, 02114, United States, 1 (617) 432 1000, avranceanu@mgh.harvard.edu %K chronic pain %K cognitive decline %K physical activity %K mind-body therapies %K aged %K telemedicine %K randomized clinical trial %K mobile phone %D 2023 %7 28.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic pain and early cognitive decline, which are costly to treat and highly prevalent among older adults, commonly co-occur, exacerbate one another over time, and can accelerate the development and progression of Alzheimer disease and related dementias. We developed the first mind-body activity program (Active Brains [AB]) tailored to the needs of older adults with chronic pain and early cognitive decline. Results from our previous study strongly supported the feasibility of conducting AB remotely and provided evidence for improvements in outcomes. Objective: We are conducting a single-blinded, National Institutes of Health stage-2, randomized clinical trial to establish the efficacy of AB versus a time-matched and dose-matched education control (Health Enhancement Program [HEP]) in improving self-reported and objective outcomes of physical, cognitive, and emotional functions in 260 participants. The methodology described in this paper was informed by the lessons learned from the first year of the trial. Methods: Participants are identified and recruited through multidisciplinary clinician–referred individuals (eg, pain psychologists and geriatricians), the Rally Research platform, social media, and community partnerships. Interested participants complete eligibility screening and electronic informed consent. Baseline assessments include self-report, performance-based measures (eg, 6-min walk test) and objective measures (eg, Repeatable Battery for the Assessment of Neuropsychological Status). Participants are mailed a wrist-worn ActiGraph device (ActiGraph LLC) to passively monitor objective function (eg, steps) during the week between the baseline assessment and the beginning of the programs, which they continue to wear throughout the programs. After baseline assessments, participants are randomized to either AB or HEP and complete 8 weekly, remote, group sessions with a Massachusetts General Hospital psychologist. The AB group receives a Fitbit (Fitbit Inc) to help reinforce increased activity. Assessments are repeated after the intervention and at the 6-month follow-up. Coprimary outcomes include multimodal physical function (self-report, performance based, and objective). Secondary outcomes are cognitive function (self-report and objective), emotional function, and pain. Results: We began recruitment in July 2022 and recruited 37 participants across 4 cohorts. Of them, all (n=37, 100%) have completed the baseline assessment, 26 (70%) have completed the posttest assessment, and 9 (24%) are actively enrolled in the intervention (total dropout: n=2, 5%). In the three cohorts (26/37, 70%) that have completed the AB or HEP, 26 (100%) participants completed all 8 group sessions (including minimal makeups), and watch adherence (1937/2072, 93.48%, average across ActiGraph and Fitbit devices) has been excellent. The fourth cohort is ongoing (9/37, 24%), and we plan to complete enrollment by March 2026. Conclusions: We aim to establish the efficacy of the AB program over a time-matched and dose-matched control in a live video-based trial and test the mechanisms through theoretically driven mediators and moderators. Findings will inform the development of a future multisite effectiveness-implementation trial. Trial Registration: ClinicalTrials.gov NCT05373745; https://classic.clinicaltrials.gov/ct2/show/NCT05373745 International Registered Report Identifier (IRRID): DERR1-10.2196/47319 %M 37768713 %R 10.2196/47319 %U https://www.researchprotocols.org/2023/1/e47319 %U https://doi.org/10.2196/47319 %U http://www.ncbi.nlm.nih.gov/pubmed/37768713 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e46877 %T Efficacy, Safety, and Evaluation Criteria of mHealth Interventions for Depression: Systematic Review %A Duarte-Díaz,Andrea %A Perestelo-Pérez,Lilisbeth %A Gelabert,Estel %A Robles,Noemí %A Pérez-Navarro,Antoni %A Vidal-Alaball,Josep %A Solà-Morales,Oriol %A Sales Masnou,Ariadna %A Carrion,Carme %+ Canary Islands Health Research Institute Foundation (FIISC), Camino Candelaria, 44, El Rosario, 38109, Spain, 34 922478320, andrea.duartediaz@sescs.es %K mobile health %K mHealth %K apps %K depression %K systematic review %K meta-analysis %D 2023 %7 27.9.2023 %9 Review %J JMIR Ment Health %G English %X Background: Depression is a significant public health issue that can lead to considerable disability and reduced quality of life. With the rise of technology, mobile health (mHealth) interventions, particularly smartphone apps, are emerging as a promising approach for addressing depression. However, the lack of standardized evaluation tools and evidence-based principles for these interventions remains a concern. Objective: In this systematic review and meta-analysis, we aimed to evaluate the efficacy and safety of mHealth interventions for depression and identify the criteria and evaluation tools used for their assessment. Methods: A systematic review and meta-analysis of the literature was carried out following the recommendations of the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. Studies that recruited adult patients exhibiting elevated depressive symptoms or those diagnosed with depressive disorders and aimed to assess the effectiveness or safety of mHealth interventions were eligible for consideration. The primary outcome of interest was the reduction of depressive symptoms, and only randomized controlled trials (RCTs) were included in the analysis. The risk of bias in the original RCTs was assessed using version 2 of the Cochrane risk-of-bias tool for randomized trials. Results: A total of 29 RCTs were included in the analysis after a comprehensive search of electronic databases and manual searches. The efficacy of mHealth interventions in reducing depressive symptoms was assessed using a random effects meta-analysis. In total, 20 RCTs had an unclear risk of bias and 9 were assessed as having a high risk of bias. The most common element in mHealth interventions was psychoeducation, followed by goal setting and gamification strategies. The meta-analysis revealed a significant effect for mHealth interventions in reducing depressive symptoms compared with nonactive control (Hedges g=−0.62, 95% CI −0.87 to −0.37, I2=87%). Hybrid interventions that combined mHealth with face-to-face sessions were found to be the most effective. Three studies compared mHealth interventions with active controls and reported overall positive results. Safety analyses showed that most studies did not report any study-related adverse events. Conclusions: This review suggests that mHealth interventions can be effective in reducing depressive symptoms, with hybrid interventions achieving the best results. However, the high level of heterogeneity in the characteristics and components of mHealth interventions indicates the need for personalized approaches that consider individual differences, preferences, and needs. It is also important to prioritize evidence-based principles and standardized evaluation tools for mHealth interventions to ensure their efficacy and safety in the treatment of depression. Overall, the findings of this study support the use of mHealth interventions as a viable method for delivering mental health care. Trial Registration: PROSPERO CRD42022304684; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=304684 %M 37756042 %R 10.2196/46877 %U https://mental.jmir.org/2023/1/e46877 %U https://doi.org/10.2196/46877 %U http://www.ncbi.nlm.nih.gov/pubmed/37756042 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e51088 %T Internet-Delivered Cognitive Behavioral Therapy Tailored to Spouses and Significant Others of Public Safety Personnel: Formative Evaluation Study %A Hadjistavropoulos,Heather D %A Reiser,Sarah J %A Beahm,Janine D %A McCall,Hugh C %A Dena,Isabelle %A Phillips,Abby R %A Scheltgen,Melissa %A Sekhar,Shimona %A Cox,Marilyn %A Cramm,Heidi %A Reid,Nathalie %+ Department of Psychology, University of Regina, 3737 Wascana Pkwy, Regina, SK, S4S 0A2, Canada, 1 306 585 5133, Heather.Hadjistavropoulos@uregina.ca %K internet-delivered cognitive behavioral therapy %K ICBT %K internet interventions %K transdiagnostic %K spouses and significant others %K public safety personnel %K formative evaluation %D 2023 %7 27.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Spouses and significant others (SSOs) of public safety personnel (PSP) are affected by the risks and requirements of these occupations. Internet-delivered cognitive behavioral therapy (ICBT) provides a convenient and accessible treatment format that can be tailored to the needs of SSOs of PSP. Objective: This study aimed to assess the initial use and client perceptions (eg, likes, helpfulness, and areas for improvement) of a self-guided, transdiagnostic ICBT course designed for Canadian SSOs of PSP and identify opportunities to further tailor ICBT for this group. Methods: SSOs were invited to complete a 5-lesson, self-guided, transdiagnostic ICBT course. Descriptive statistics were used to analyze the demographic and clinical characteristics of participants. Content analysis was used to analyze the data from open-ended survey responses and interviews to understand their experiences with ICBT. Results: Clients (N=118) endorsed various mental health concerns (eg, depression, anxiety, posttraumatic stress symptoms, and relationship concerns) with a range of severity levels. Most clients identified as White (110/116, 94.8%) and women (108/116, 91.5%), with a mean age of 42.03 (SD 9.36) years. Of the 26 clients who were interviewed, 89% (23/26) reported believing that ICBT is helpful and 92% (24/26) reported finding at least 1 skill helpful. Clients provided suggestions for course improvements. On the basis of this feedback and quantitative data, changes were made to areas such as the delivery of materials, content, case stories, and timelines. Overall, the results indicated that many SSOs of PSP had positive perceptions of ICBT tailored to their needs and found several aspects of the course helpful, supporting the continued delivery of tailored ICBT to this population. However, there remains a need for continued promotion of the course and outreach to diverse groups of SSOs of PSP. Conclusions: Findings from this formative evaluation provide insight into the unique experiences and needs of SSOs of PSP and provide preliminary evidence for the use of tailored ICBT to support the mental health of this group in Canada. %M 37756033 %R 10.2196/51088 %U https://formative.jmir.org/2023/1/e51088 %U https://doi.org/10.2196/51088 %U http://www.ncbi.nlm.nih.gov/pubmed/37756033 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e49668 %T Mobile Phone Text Messages to Support People to Stop Smoking by Switching to Vaping: Codevelopment, Coproduction, and Initial Testing Study %A Sideropoulos,Vassilis %A Vangeli,Eleni %A Naughton,Felix %A Cox,Sharon %A Frings,Daniel %A Notley,Caitlin %A Brown,Jamie %A Kimber,Catherine %A Dawkins,Lynne %+ Department of Psychology & Human Development, IOE, UCL’s Faculty of Education and Society, University College London, 20 Bedford Way, London, WC1H 0AL, United Kingdom, 44 02035495417, v.sideropoulos@ucl.ac.uk %K coproduction %K SMS text messages %K e-cigarette %K smoking %K eHealth %K vaping %K mobile phone %K codevelopment %K text message %D 2023 %7 27.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: SMS text messages are affordable, scalable, and effective smoking cessation interventions. However, there is little research on SMS text message interventions specifically designed to support people who smoke to quit by switching to vaping. Objective: Over 3 phases, with vapers and smokers, we codeveloped and coproduced a mobile phone SMS text message program. The coproduction paradigm allowed us to collaborate with researchers and the community to develop a more relevant, acceptable, and equitable SMS text message program. Methods: In phase 1, we engaged people who vape via Twitter and received 167 responses to our request to write SMS text messages for people who wish to quit smoking by switching to vaping. We screened, adjusted, refined, and themed the messages, resulting in a set of 95 that were mapped against the Capability, Opportunity, and Motivation–Behavior constructs. In phase 2, we evaluated the 95 messages from phase 1 via a web survey where participants (66/202, 32.7% woman) rated up to 20 messages on 7-point Likert scales on 9 constructs: being understandable, clear, believable, helpful, interesting, inoffensive, positive, and enthusiastic and how happy they would be to receive the messages. In phase 3, we implemented the final set of SMS text messages as part of a larger randomized optimization trial, in which 603 participants (mean age 38.33, SD 12.88 years; n=369, 61.2% woman) received SMS text message support and then rated their usefulness and frequency and provided free-text comments at the 12-week follow-up. Results: For phase 2, means and SDs were calculated for each message across the 9 constructs. Those with means below the neutral anchor of 4 or with unfavorable comments were discussed with vapers and further refined or removed. This resulted in a final set of 78 that were mapped against early, mid-, or late stages of quitting to create an order for the messages. For phase 3, a total of 38.5% (232/603) of the participants provided ratings at the 12-week follow-up. In total, 69.8% (162/232) reported that the SMS text messages had been useful, and a significant association between quit rates and usefulness ratings was found (χ21=9.6; P=.002). A content analysis of free-text comments revealed that the 2 most common positive themes were helpful (13/47, 28%) and encouraging (6/47, 13%) and the 2 most common negative themes were too frequent (9/47, 19%) and annoying (4/47, 9%). Conclusions: In this paper, we describe the initial coproduction and codevelopment of a set of SMS text messages to help smokers stop smoking by transitioning to vaping. We encourage researchers to use, further develop, and evaluate the set of SMS text messages and adapt it to target populations and relevant contexts. %M 37756034 %R 10.2196/49668 %U https://formative.jmir.org/2023/1/e49668 %U https://doi.org/10.2196/49668 %U http://www.ncbi.nlm.nih.gov/pubmed/37756034 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46310 %T Mindfulness-Based Mobile Health to Address Unhealthy Eating Among Middle-Aged Sexual Minority Women With Early Life Adversity: Mixed Methods Feasibility Trial %A Sun,Shufang %A Nardi,William %A Murphy,Matthew %A Scott,Ty %A Saadeh,Frances %A Roy,Alexandra %A Brewer,Judson %+ Department of Behavioral and Social Sciences, Brown University, 121 South Main Street, Providence, RI, 02903, United States, 1 401 863 5735, shufang_sun@brown.edu %K mobile health %K mindfulness %K obesity %K sexual minority women %K early life adversity %K cell phone %K mobile phone %D 2023 %7 26.9.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Sexual minority women (lesbian, gay, bisexual, pansexual, queer, and other nonheterosexual women) remain considerably underrepresented in health research despite being at a higher risk for diabetes and obesity as well as stigma and psychological distress than their heterosexual peers. In addition, early life adversity (ELA) is prevalent among sexual minority women, which further increases risks for obesity, psychological distress, and poor cardiovascular health. App-based mindfulness interventions are potentially promising for this group in mitigating the adverse health effects of ELA, reducing food craving and unhealthy eating, addressing the risks associated with obesity. Objective: This mixed methods feasibility trial aimed to test a mindfulness-based mobile health approach for middle-aged sexual minority women (aged 30-55 years) with ELA and overweight or obesity (BMI ≥25 kg/m2) to improve health outcomes. Methods: The single-arm trial was advertised on social media and various lesbian, gay, bisexual, transgender, and queer web-based groups. At baseline, after the intervention (2 months), and at the 4-month follow-up, participants completed assessments of primary outcomes (food craving, emotional eating, and weight via a mailed scale) and secondary outcomes (depression, anxiety, mindfulness, and emotion dysregulation). A standardized weight measure was mailed to participants for weight reporting. Feasibility and acceptability were assessed after the intervention via surveys and semistructured exit interviews. Results: We screened 442 individuals, among which 30 eligible sexual minority women (mean age 40.20, SD 7.15 years) from various US regions were enrolled in the study. At baseline, 86% (26/30) and 80% (24/30) of participants had elevated depressive and anxiety symptoms, respectively. Among the 30 enrolled participants, 20 (66%) completed all intervention modules, 25 (83%) were retained at the 2-month follow-up, and 20 (66%) were retained at the 4-month follow-up. None reported adverse effects. From baseline to the 4-month follow-up, large effects were found in food craving (Cohen d=1.64) and reward-based eating (Cohen d=1.56), whereas small effects were found with weight (Cohen d=0.20; 4.21 kg on average). Significant improvements were also found in the secondary outcomes (depression, Cohen d=0.98; anxiety, Cohen d=0.50; mindfulness, Cohen d=0.49; and emotion dysregulation, Cohen d=0.44; all P<.05). Participants with higher levels of parental verbal and emotional abuse were particularly responsive to the intervention. Participants reported that the program aligned with their goals and expectations, was easy to use, and facilitated changes in eating behavior and mental health. Barriers to engagement included the need for diverse teachers, individualized support, and body positive language. Conclusions: This early phase feasibility trial provides proof-of-concept support for a mindfulness mobile health approach to improve obesity-related outcomes among sexual minority women and warrants a larger randomized controlled trial in the future. The findings also suggest the need to address trauma and psychological health when addressing weight-related outcomes among sexual minority women. %M 37751273 %R 10.2196/46310 %U https://www.jmir.org/2023/1/e46310 %U https://doi.org/10.2196/46310 %U http://www.ncbi.nlm.nih.gov/pubmed/37751273 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42474 %T The Use of eHealth for Pharmacotherapy Management With Patients With Respiratory Disease, Cardiovascular Disease, or Diabetes: Scoping Review %A Bakema,Robbert %A Smirnova,Daria %A Biri,Despina %A Kocks,Janwillem W H %A Postma,Maarten J %A de Jong,Lisa A %+ Department of Health Sciences, University Medical Center Groningen, University of Groningen, Hanzeplein 1, Groningen, 9713 GZ, Netherlands, 31 630048956, l.a.de.jong@rug.nl %K telemedicine %K polypharmacy %K pharmacotherapy %K diabetes mellitus %K cardiovascular diseases %K asthma %K pulmonary disease, chronic obstructive %K interventions e-health %D 2023 %7 26.9.2023 %9 Review %J J Med Internet Res %G English %X Background: eHealth is increasingly considered an important tool for supporting pharmacotherapy management. Objective: We aimed to assess the (1) use of eHealth in pharmacotherapy management with patients with asthma or chronic obstructive pulmonary disease (COPD), diabetes, or cardiovascular disease (CVD); (2) effectiveness of these interventions on pharmacotherapy management and clinical outcomes; and (3) key factors contributing to the success of eHealth interventions for pharmacotherapy management. Methods: We conducted a scoping review following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping review) statement. Databases searched included Embase, MEDLINE (PubMed), and Cochrane Library. Screening was conducted by 2 independent researchers. Eligible articles were randomized controlled trials and cohort studies assessing the effect of an eHealth intervention for pharmacotherapy management compared with usual care on pharmacotherapy management or clinical outcomes in patients with asthma or COPD, CVD, or diabetes. The interventions were categorized by the type of device, pharmacotherapy management, mode of delivery, features, and domains described in the conceptual model for eHealth by Shaw at al (Health in our Hands, Interacting for Health, Data Enabling Health). The effectiveness on pharmacotherapy management outcomes and patient- and clinician-reported clinical outcomes was analyzed per type of intervention categorized by number of domains and features to identify trends. Results: Of 63 studies, 16 (25%), 31 (49%), 13 (21%), and 3 (5%) included patients with asthma or COPD, CVD, diabetes, or CVD and diabetes, respectively. Most (38/63, 60%) interventions targeted improving medication adherence, often combined for treatment plan optimization. Of the 16 asthma or COPD interventions, 6 aimed to improve inhaled medication use. The majority (48/63, 76%) of the studies provided an option for patient feedback. Most (20/63, 32%) eHealth interventions combined all 3 domains by Shaw et al, while 25% (16/63) combined Interacting for Health with Data Enabling Health. Two-thirds (42/63, 67%) of the studies showed a positive overall effect. Respectively, 48% (23/48), 57% (28/49), and 39% (12/31) reported a positive effect on pharmacotherapy management and clinician- and patient-reported clinical outcomes. Pharmacotherapy management and patient-reported clinical outcomes, but not clinician-reported clinical outcomes, were more often positive in interventions with ≥3 features. There was a trend toward more studies reporting a positive effect on all 3 outcomes with more domains by Shaw et al. Of the studies with interventions providing patient feedback, more showed a positive clinical outcome, compared with studies with interventions without feedback. This effect was not seen for pharmacotherapy management outcomes. Conclusions: There is a wide variety of eHealth interventions combining various domains and features to target pharmacotherapy management in asthma or COPD, CVD, and diabetes. Results suggest feedback is key for a positive effect on clinician-reported clinical outcomes. eHealth interventions become more impactful when combining domains. %M 37751232 %R 10.2196/42474 %U https://www.jmir.org/2023/1/e42474 %U https://doi.org/10.2196/42474 %U http://www.ncbi.nlm.nih.gov/pubmed/37751232 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 6 %N %P e46738 %T Co-Creating a Digital Life-Integrated Self-Assessment for Older Adults: User Experience Study %A Böttinger,Melissa J %A Litz,Elena %A Gordt-Oesterwind,Katharina %A Jansen,Carl-Philipp %A Memmer,Nicole %A Mychajliw,Christian %A Radeck,Leon %A Bauer,Jürgen M %A Becker,Clemens %+ Digital Unit, Center for Geriatric Medicine, Heidelberg University Hospital, Bergheimer Str. 20, Heidelberg, 69115, Germany, 49 6221 54 8146, boettinger@nar.uni-heidelberg.de %K aged %K self-assessment %K mobile apps %K mobile health %K mHealth %K community-based participatory research %K co-creation %K comprehensive geriatric assessment %K mobile phone %D 2023 %7 26.9.2023 %9 Original Paper %J JMIR Aging %G English %X Background: Older adults are at increased risk of developing health disorders and functional decline. However, owing to time constraints and considerable effort, physicians rarely conduct comprehensive assessments to detect early signs of negative trajectories. If designed properly, digital technologies could identify health risks already at a preclinical stage, thereby facilitating preventive efforts and targeted intervention. For this purpose, a Life-integrated Self-Assessment (LiSA) tablet system will be developed through a structured co-creation process. Objective: This study aims to investigate older adults’ perceptions of different self-assessment domains, components affecting user experience, risks and benefits associated with LiSA, characteristics of potential LiSA users, and the LiSA concept in general. Methods: A total of 10 community-dwelling older adults aged ≥70 years were recruited. In total, 6 co-creation workshops were held and started with expert input followed by semistructured discussion rounds. Participants performed hands-on activities with a tablet, including testing of preinstalled self-assessment apps. All workshops were audio recorded and additionally documented by the researchers using flipcharts, notes, and photos. Qualitative content analysis was used to analyze the data following a deductive-inductive approach guided by the Optimized Honeycomb Model for user experience. Results: The group (mean age 77.8, SD 5.1 years) was heterogeneous in terms of previous technology experience and health status. The mean workshop duration was 2 hours (122.5, SD 4.43 min), and an average of 8 (SD 1.15) participants attended each workshop. A total of 11 thematic categories were identified, covering results on all research questions. Participants emphasized a strong interest in conducting a digital self-assessment of physical activity and function and sensory and cognitive functions and requested additional features such as recommendations for actions or reminders. LiSA was perceived as empowering and a motivator to engage in active health care planning as well as enabling shared and informed decision-making. Concerns and barriers included the lack of technical competence, feelings of frustration, and fear of being left alone, with negative assessment results. In essence, participants expressed a positive attitude toward using LiSA repeatedly and identified it as an option to increase the chances of maintaining independence when growing older. Conclusions: The co-creation participants supported the LiSA approach and were interested in performing regular self-assessments on a long-term basis. In their opinion, LiSA should include relevant assessments capturing physical activity and function and sensory and cognitive functions as well as recommendations for actions. It should be customizable to individual needs. These results will form the basis for a prototype. Iterative development and validation will aim to make LiSA accessible in the public domain as a reliable tablet-based system for self-assessment. %M 37751274 %R 10.2196/46738 %U https://aging.jmir.org/2023/1/e46738 %U https://doi.org/10.2196/46738 %U http://www.ncbi.nlm.nih.gov/pubmed/37751274 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e52161 %T Advancing Understanding of Just-in-Time States for Supporting Physical Activity (Project JustWalk JITAI): Protocol for a System ID Study of Just-in-Time Adaptive Interventions %A Park,Junghwan %A Kim,Meelim %A El Mistiri,Mohamed %A Kha,Rachael %A Banerjee,Sarasij %A Gotzian,Lisa %A Chevance,Guillaume %A Rivera,Daniel E %A Klasnja,Predrag %A Hekler,Eric %+ Herbert Wertheim School of Public Health and Human Longevity Science, University of California, San Diego, 9500 Gilman Dr, La Jolla, CA, 92093, United States, 1 8584299370, jup014@ucsd.edu %K just-in-time adaptive intervention %K JITAI %K just-in-time %K JIT %K walking %K physical activity %K needs %K opportunity %K receptivity %K mobile phone %D 2023 %7 26.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Just-in-time adaptive interventions (JITAIs) are designed to provide support when individuals are receptive and can respond beneficially to the prompt. The notion of a just-in-time (JIT) state is critical for JITAIs. To date, JIT states have been formulated either in a largely data-driven way or based on theory alone. There is a need for an approach that enables rigorous theory testing and optimization of the JIT state concept. Objective: The purpose of this system ID experiment was to investigate JIT states empirically and enable the empirical optimization of a JITAI intended to increase physical activity (steps/d). Methods: We recruited physically inactive English-speaking adults aged ≥25 years who owned smartphones. Participants wore a Fitbit Versa 3 and used the study app for 270 days. The JustWalk JITAI project uses system ID methods to study JIT states. Specifically, provision of support systematically varied across different theoretically plausible operationalizations of JIT states to enable a more rigorous and systematic study of the concept. We experimentally varied 2 intervention components: notifications delivered up to 4 times per day designed to increase a person’s steps within the next 3 hours and suggested daily step goals. Notifications to walk were experimentally provided across varied operationalizations of JIT states accounting for need (ie, whether daily step goals were previously met or not), opportunity (ie, whether the next 3 h were a time window during which a person had previously walked), and receptivity (ie, a person previously walked after receiving notifications). Suggested daily step goals varied systematically within a range related to a person’s baseline level of steps per day (eg, 4000) until they met clinically meaningful targets (eg, averaging 8000 steps/d as the lower threshold across a cycle). A series of system ID estimation approaches will be used to analyze the data and obtain control-oriented dynamical models to study JIT states. The estimated models from all approaches will be contrasted, with the ultimate goal of guiding rigorous, replicable, empirical formulation and study of JIT states to inform a future JITAI. Results: As is common in system ID, we conducted a series of simulation studies to formulate the experiment. The results of our simulation studies illustrated the plausibility of this approach for generating informative and unique data for studying JIT states. The study began enrolling participants in June 2022, with a final enrollment of 48 participants. Data collection concluded in April 2023. Upon completion of the analyses, the results of this study are expected to be submitted for publication in the fourth quarter of 2023. Conclusions: This study will be the first empirical investigation of JIT states that uses system ID methods to inform the optimization of a scalable JITAI for physical activity. Trial Registration: ClinicalTrials.gov NCT05273437; https://clinicaltrials.gov/ct2/show/NCT05273437 International Registered Report Identifier (IRRID): DERR1-10.2196/52161 %M 37751237 %R 10.2196/52161 %U https://www.researchprotocols.org/2023/1/e52161 %U https://doi.org/10.2196/52161 %U http://www.ncbi.nlm.nih.gov/pubmed/37751237 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49698 %T Feasibility Study of Virtual Reality–Based Cognitive Behavioral Therapy for Patients With Depression: Protocol for an Open Trial and Therapeutic Intervention %A Ito,Ai %A Hiyoshi,Fumikazu %A Kanie,Ayako %A Maruyama,Azumi %A Oba,Mari S %A Kito,Shinsuke %+ Department of Clinical Psychology, National Center Hospital, National Center of Neurology and Psychiatry, 4 Chome-1-1 Ogawahigashicho, Kodaira-shi, 187-8551, Japan, 81 42 341 2711, kito@ncnp.go.jp %K depression %K cognitive behavioral therapy %K virtual reality %K CBT %K feasibility study %K open trial %K VR %D 2023 %7 26.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: The clinical usefulness of cognitive behavioral therapy (CBT) for patients with depression who do not remit with pharmacotherapy has been recognized. However, the longer time burden on health care providers associated with conducting CBT and the lack of a system for providing CBT lead to inadequate CBT provision to patients who wish to receive it. Objective: We aim to evaluate the feasibility of introducing virtual reality (VR) into CBT for patients with depression. Methods: This is a single-center, interventional, exploratory, single-arm, nonrandomized, open, pre-post–comparative feasibility study of an unapproved medical device program to evaluate the acceptability, preliminary efficacy, and safety of the study device. Eligible patients meet the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) for major depressive disorder, have a 17-item Hamilton Depression Rating Scale (HAMD-17) score of ≥12, and are aged 18-65 years. The sample will comprise 12 patients. VR-based CBT (CBT-VR) sessions will be conducted once a week in an outpatient setting. CBT-VR has been developed in accordance with 6 stages and 16 sessions in the current CBT therapist manual. VR contents and other components correspond to the themes of these 16 sessions. The flow of CBT-VR treatment is similar to that of normal CBT; however, this product replaces the in-person portion of CBT. The primary end point will be the change in the HAMD-17 score from baseline up to 16 sessions. Secondary end points will be treatment retention; psychiatrist consultation time; satisfaction with the equipment or program; ease of use; homework compliance; change in the HAMD-17 score from baseline up to 8 sessions; change in Montgomery-Åsberg Depression Rating Scale (MADRS), Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR), EQ-5D-5L, and Clinical Global Impressions (CGI) scores from baseline up to 8 and 16 sessions; and change in remission and response rates and HAMD-17, MADRS, QIDS-SR, and EQ-5D-5L scores from baseline to 3 and 6 months post intervention (or discontinuation). CBT-VR’s feasibility will be assessed at baseline, after 8 sessions, after 16 sessions, or treatment discontinuation, by measuring the time required for testing and medical care during each session and with a patient questionnaire. After intervention discontinuation, a follow-up evaluation will be conducted unless the patient withdraws consent or otherwise discontinues participation in the study after 3 and 6 months. Results: Participant recruitment started on November 30, 2022, and data collection is ongoing as of September 2023. Conclusions: This study is the first step in testing the acceptability, feasibility, and preliminary efficacy and safety of CBT-VR for patients with depression without controls in an open-label trial. If its feasibility for depression treatment is confirmed, we intend to proceed to a large-scale validation study. Trial Registration: Japan Registry of Clinical Trials jRCTs032220481; https://jrct.niph.go.jp/en-latest-detail/jRCTs032220481 International Registered Report Identifier (IRRID): DERR1-10.2196/49698 %M 37751242 %R 10.2196/49698 %U https://www.researchprotocols.org/2023/1/e49698 %U https://doi.org/10.2196/49698 %U http://www.ncbi.nlm.nih.gov/pubmed/37751242 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44359 %T Use of Biological Feedback as a Health Behavior Change Technique in Adults: Scoping Review %A Richardson,Kelli M %A Jospe,Michelle R %A Saleh,Ahlam A %A Clarke,Thanatcha Nadia %A Bedoya,Arianna R %A Behrens,Nick %A Marano,Kari %A Cigan,Lacey %A Liao,Yue %A Scott,Eric R %A Guo,Jessica S %A Aguinaga,April %A Schembre,Susan M %+ Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University, 2115 Wisconsin Ave NW, Washington, DC, 20007, United States, 1 202 444 2223, ss4731@georgetown.edu %K monitoring, physiologic %K biomarkers %K feedback, psychological %K health behavior %K health promotion %K biological %K adults %K biosensing %K technology %K support %K intervention %K electronic database %K cardiovascular disease %K obesity %K device %D 2023 %7 25.9.2023 %9 Review %J J Med Internet Res %G English %X Background: Recent advancements in personal biosensing technology support the shift from standardized to personalized health interventions, whereby biological data are used to motivate health behavior change. However, the implementation of interventions using biological feedback as a behavior change technique has not been comprehensively explored. Objective: The purpose of this review was to (1) map the domains of research where biological feedback has been used as a behavior change technique and (2) describe how it is implemented in behavior change interventions for adults. Methods: A comprehensive systematic search strategy was used to query 5 electronic databases (Ovid MEDLINE, Elsevier Embase, Cochrane Central Register of Controlled Trials, EBSCOhost PsycINFO, and ProQuest Dissertations & Theses Global) in June 2021. Eligible studies were primary analyses of randomized controlled trials (RCTs) in adults that incorporated biological feedback as a behavior change technique. DistillerSR was used to manage the literature search and review. Results: After removing 49,500 duplicates, 50,287 articles were screened and 767 articles were included. The earliest RCT was published in 1972 with a notable increase in publications after 2000. Biological feedback was most used in RCTs aimed at preventing or managing diabetes (n=233, 30.4%), cardiovascular disease (n=175, 22.8%), and obesity (n=115, 15%). Feedback was often given on multiple biomarkers and targeted multiple health behaviors. The most common biomarkers used were anthropometric measures (n=297, 38.7%), blood pressure (n=238, 31%), and glucose (n=227, 29.6%). The most targeted behaviors were diet (n=472, 61.5%), physical activity (n=417, 54.4%), and smoking reduction (n=154, 20.1%). The frequency and type of communication by which biological feedback was provided varied by the method of biomarker measurement. Of the 493 (64.3%) studies where participants self-measured their biomarker, 476 (96.6%) received feedback multiple times over the intervention and 468 (94.9%) received feedback through a biosensing device. Conclusions: Biological feedback is increasingly being used to motivate behavior change, particularly where relevant biomarkers can be readily assessed. Yet, the methods by which biological feedback is operationalized in intervention research varied, and its effectiveness remains unclear. This scoping review serves as the foundation for developing a guiding framework for effectively implementing biological feedback as a behavior change technique. Trial Registration: Open Science Framework Registries; https://doi.org/10.17605/OSF.IO/YP5WAd International Registered Report Identifier (IRRID): RR2-10.2196/32579 %M 37747766 %R 10.2196/44359 %U https://www.jmir.org/2023/1/e44359 %U https://doi.org/10.2196/44359 %U http://www.ncbi.nlm.nih.gov/pubmed/37747766 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e47350 %T Specifying the Efficacy of Digital Therapeutic Tools for Depression and Anxiety: Retrospective, 2-Cohort, Real-World Analysis %A Fundoiano-Hershcovitz,Yifat %A Breuer Asher,Inbar %A Ritholz,Marilyn D %A Feniger,Eitan %A Manejwala,Omar %A Goldstein,Pavel %+ Dario Health, Ofek 8, 5 Tarshish St, Caesarea, 3079821, Israel, 972 525296979, yifat@dariohealth.com %K mental health %K depression %K anxiety %K digital health %K coaching %K behavioral health %K breathing exercises %K behavioral change %K digital health intervention %K cognitive behavior therapy %K health outcome %K health app %K intervention %K cohort %K retrospective %D 2023 %7 22.9.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression and anxiety are the main sources of work and social disabilities as well as health-related problems around the world. Digital therapeutic solutions using cognitive behavioral therapy have demonstrated efficacy in depression and anxiety. A common goal of digital health apps is to increase user digital engagement to improve outcomes. However, there is a limited understanding of the association between digital platform components and clinical outcomes. Objective: The aim of the study is to investigate the contribution of specific digital engagement tools to mental health conditions. We hypothesized that participation in coaching sessions and breathing exercises would be associated with a reduction in depression and anxiety. Methods: Depression and general anxiety symptoms were evaluated in real-world data cohorts using the digital health platform for digital intervention and monitoring change. This retrospective real-world analysis of users on a mobile platform–based treatment followed two cohorts of people: (1) users who started with moderate levels of depression and completed at least 2 depression assessments (n=519) and (2) users who started with moderate levels of anxiety and completed at least 2 anxiety assessments (n=474). Levels of depression (Patient Health Questionnaire-9) and anxiety (Generalized Anxiety Disorder-7) were tracked throughout the first 16 weeks. A piecewise mixed-effects model was applied to model the trajectories of the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder-7 mean scores in 2 segments (1-6 weeks and 7-16 weeks). Finally, simple slope analysis was used for the interpretation of the interactions probing the moderators: coaching sessions and breathing exercises in both depression and anxiety cohorts. Results: Analysis revealed a significant decrease in depression symptoms (β=–.37, 95% CI –0.46 to 0.28; P≤.001) during the period of weeks 1-6 of app use, which was maintained during the period of 7-16 weeks. Coach interaction significantly moderated the reduction in depression symptoms during the period of weeks 1-6 (β=–.03, 95% CI –0.05 to –0.001; P=.02). A significant decrease in anxiety symptoms (β=–.41, 95% CI –0.50 to –0.33; P≤.001) was revealed during the period of 1-6 weeks, which was maintained during the period of 7-16 weeks. Breathing exercises significantly moderated the reduction in anxiety symptoms during the period of 1-6 weeks (β=–.07, 95% CI –0.14 to –0.01; P=.04). Conclusions: This study demonstrated general improvement followed by a period of stability of depression and anxiety symptoms associated with cognitive behavioral therapy–based digital intervention. Interestingly, engagement with a coaching session but not a breathing exercise was associated with a reduction in depression symptoms. Moreover, breathing exercise but not engagement with a coaching session was associated with a reduction of anxiety symptoms. These findings emphasize the importance of using a personalized approach to behavioral health during digital health interventions. %M 37738076 %R 10.2196/47350 %U https://www.jmir.org/2023/1/e47350 %U https://doi.org/10.2196/47350 %U http://www.ncbi.nlm.nih.gov/pubmed/37738076 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42786 %T The Effect of Internet-Based Cognitive Behavioral Therapy on Major Depressive Disorder: Randomized Controlled Trial %A Lin,Ziyi %A Cheng,Lu %A Han,Xue %A Wang,Hongqiong %A Liao,Yuhua %A Guo,Lan %A Shi,Jingman %A Fan,Beifang %A Teopiz,Kayla M %A Jawad,Muhammad Youshay %A Zhang,Huimin %A Chen,Yan %A Lu,Ciyong %A McIntyre,Roger S %+ Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, No. 74 Zhongshan Rd 2, Guangzhou, 510080, China, 86 020 87332477, luciyong@mail.sysu.edu.cn %K depressive symptoms %K major depressive disorder %K internet-based cognitive behavioral therapy %K self-efficacy %K stigma %K social function %K health-related quality of life %K mental health services %D 2023 %7 22.9.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Many people living with major depressive disorder (MDD) in China do not receive treatment owing to a lack of mental health services, along with significant stigma toward mental illness. Internet-based cognitive behavioral therapy (ICBT) has been proposed to increase access to mental health care for people with MDD. Objective: The aims of this study were to (1) evaluate the efficacy of ICBT for depressive symptoms in patients with MDD; (2) evaluate the effect of ICBT on anxiety symptoms, nonspecific psychological distress, general self-efficacy, depression stigma, social function, and health-related quality of life (HRQoL); and (3) explore the acceptability of and satisfaction with the ICBT program among participants. Methods: Patients with MDD were enrolled and randomized to the ICBT group or the waiting-list control (WLC) group. The ICBT group received ICBT delivered through a WeChat mini-program with general support by nonspecialists. Participants in the 2 groups were self-evaluated online at baseline and posttreatment for changes in the primary outcome (ie, depressive symptoms) and secondary outcomes (ie, anxiety symptoms, nonspecific psychological distress, general self-efficacy, depression stigma, social functional impairment, and HRQoL). Changes in outcomes were measured by changes in overall scores on respective scales, and response and remission rates were calculated based on depressive symptoms. The acceptability of and satisfaction with the ICBT program were measured by treatment adherence and participants’ feelings (ie, modules seriously completed, perceived benefit, and satisfaction). Results: We included 40 patients who were randomly assigned to the ICBT group and 44 who were assigned to the WLC group. Compared with the WLC group, the ICBT group had fewer depressive symptoms, fewer anxiety symptoms, less nonspecific psychological distress, and greater general self-efficacy. Moreover, the ICBT group had higher response (18/31, 58%) and remission rates (17/31, 55%). The adherence rate in the ICBT group was 78% (31/40), and the majority of participants who completed all ICBT modules were satisfied with the ICBT program. Conclusions: ICBT demonstrated greater improvements in depressive symptoms, anxiety symptoms, nonspecific psychological distress, and general self-efficacy among selected patients with MDD in comparison with the findings in waiting-list controls. The ICBT program in this study had good acceptability and satisfaction among participants. Trial Registration: Chinese Clinical Trial Registry (ChiCTR2100046425); https://tinyurl.com/bdcrj4zv %M 37738092 %R 10.2196/42786 %U https://www.jmir.org/2023/1/e42786 %U https://doi.org/10.2196/42786 %U http://www.ncbi.nlm.nih.gov/pubmed/37738092 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46458 %T Efficacy of a Text-Based Mental Health Coaching App in Improving the Symptoms of Stress, Anxiety, and Depression: Randomized Controlled Trial %A Lim,Yee Siew %A Quek,Jia Hui %A Ching,Xiu Wei %A Lim,Dominic Tao Ran %A Lim,Kean Ghee %A Thuraisingham,Chandramani %A George,Parikial Philip %+ International Medical University (IMU), Jalan Rasah, Bukit Rasah, Seremban, 70300, Malaysia, 60 67677798, lim.yeesiew@outlook.com %K digital mental health %K mobile health %K randomized control trial %K mobile phone %K mental health %K Depression, Anxiety, and Stress Scale–21 items %K DASS-21 %K Asia %K Malaysia %D 2023 %7 22.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Stress, anxiety, and depression are major mental health concerns worldwide. A wide variety of digital mental health interventions have demonstrated efficacy in improving one’s mental health status, and digital interventions that involve some form of human involvement have been shown to demonstrate greater efficacy than self-guided digital interventions. Studies demonstrating the efficacy of digital mental health interventions within the Asian region are scarce. Objective: This study aimed to investigate the potential efficacy of the digital mental health intervention, ThoughtFullChat, which consists of one-on-one, asynchronous, text-based coaching with certified mental health professionals and self-guided tools, in improving self-reported symptoms of depression, anxiety, and stress. The study also aims to examine the potential differences in efficacy among occupational subgroups and between sexes. Methods: A randomized controlled study was conducted among housemen (trainee physicians), students, faculty members, and corporate staff at International Medical University, Malaysia. A total of 392 participants were enrolled and randomized to the intervention (n=197, 50.3%) and control (n=195, 49.7%) groups. Depression, anxiety, and stress symptoms were measured using the Depression, Anxiety, and Stress Scale–21 items at baseline and after the 3-month intervention period. The Satisfaction with Life Scale and Brief Resilience Scale were also included, along with a questionnaire about demographics. Results: Significant decrease was observed in depression (P=.02) and anxiety (P=.002) scores in the intervention group. A subgroup (corporate staff) also demonstrated significant decrease in stress (P=.005) alongside depression (P=.006) and anxiety (P=.002). Females showed significant improvements in depression (P=.02) and anxiety (P<.001) when compared with males. Conclusions: This study provides evidence that the ThoughtFullChat app is effective in improving the symptoms of depression, anxiety, and stress in individuals, particularly among corporate staff from the educational field. It also supports the notion that mobile mental health apps that connect users to mental health professionals in a discreet and cost-efficient manner can make important contributions to the improvement of mental health outcomes. The differential improvements among occupational subgroups and between sexes in this study indicate the need for future digital mental health app designs to consider an element of personalization focused on systemic components relating to occupation. Trial Registration: Clinicaltrials.gov NCT04944277; https://classic.clinicaltrials.gov/ct2/show/NCT04944277 %M 37738081 %R 10.2196/46458 %U https://formative.jmir.org/2023/1/e46458 %U https://doi.org/10.2196/46458 %U http://www.ncbi.nlm.nih.gov/pubmed/37738081 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45535 %T Technology-Enabled Intervention to Enhance Mindfulness, Safety, and Health Promotion Among Corrections Professionals: Protocol for a Prospective Quasi-Experimental Trial %A Elliot,Diane %A Kuehl,Kerry %A DeFrancesco,Carol %A McGinnis,Wendy %A Ek,Susanna %A Van Horne,Allee %A Kempany,Katherine Ginsberg %+ Health Promotion & Sports Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road CR110, Portland, OR, 97239, United States, 1 5037995598, elliotd@ohsu.edu %K corrections professionals %K mindfulness %K total worker health %K occupational safety %K digital %K health promotion %K safety %K depression %K suicide %K obesity %K cardiovascular disease %K well-being %K stress %K survey %K healthy eating %K physical activity %K mood %K vascular health %K injury %K cop %K police %K security %K undercover %K remand %K detention %K prison %K state correctional %K state corrections %K correction %K penitentiary %D 2023 %7 22.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Correction professionals are a highly stressed workforce with heightened risks for depression, suicide, obesity, cardiovascular disease, and injury. These professionals, largely hidden from view, have received little study concerning means to improve their safety, health, and well-being. In other settings, mindfulness has resulted in lowered stress, along with other benefits. We hypothesized that a program that promoted mindfulness combined with more typical health and safety components could uniquely benefit corrections professionals. Objective: This project will assess a novel scalable, self-administered program to enhance the mindfulness, safety, and health of a vulnerable worker group. Methods: In partnership with the Oregon Department of Corrections, we are conducting a prospective quasi-experimental trial of a safety, health, and mindfulness program among 100 corrections professionals from 2 institutions. Survey and physiologic data will be collected at enrollment, upon weekly program completion (3 months), and at 9 months after enrollment. Primary outcome behaviors promoted by the program are being mindful, healthier eating, more physical activity, and greater restorative sleep. Secondary downstream benefits are anticipated in stress level, mood, positive feelings about the organization, vascular health, and cellular aging, along with job performance, injuries, and economic costs. Participants will meet in-person or in a Zoom-type meeting as 3- to 5-member coworker groups during their usual work hours for 30-minute sessions once a week for 12 weeks. The program uses self-guided web-based learning modules that include brief mindfulness practice, and it is accessible by smartphone, tablet, or laptop. Daily mindfulness practice is encouraged between sessions, which is facilitated by the study website and group format. The modules’ structure emphasizes prerequisite knowledge, peer support, skill practice, self-monitoring, and enhancing self-efficacy for change. The program continues through self-directed use of the Headspace app following the 12 weekly sessions. Results: Participants are being enrolled, and the intervention is ready to launch. Conclusions: Although mindfulness training has gained traction for worker well-being, its usual format requires a skilled trainer, an initial retreat, and weekly 2-hour meetings for several weeks. The content is limited to mindfulness without safety or health promotion aspects. The need for skilled trainers and time commitment limits the scalability of the usual mindfulness interventions. The planned program is an innovative combination of technology, e-learning, and a group format to add mindfulness to a safety and health curriculum. If acceptable and effective, the format would facilitate its widespread use. Trial Registration: ClinicalTrials.gov NCT05608889; https://classic.clinicaltrials.gov/ct2/show/NCT05608889 International Registered Report Identifier (IRRID): PRR1-10.2196/45535 %M 36602914 %R 10.2196/45535 %U https://www.researchprotocols.org/2023/1/e45535 %U https://doi.org/10.2196/45535 %U http://www.ncbi.nlm.nih.gov/pubmed/36602914 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 6 %N %P e41185 %T Uptake and Use of Care Companion, a Web-Based Information Resource for Supporting Informal Carers of Older People: Mixed Methods Study %A Dale,Jeremy %A Nanton,Veronica %A Day,Theresa %A Apenteng,Patricia %A Bernstein,Celia Janine %A Grason Smith,Gillian %A Strong,Peter %A Procter,Rob %+ Academic Primary Care Unit, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL, United Kingdom, 44 2476 522891, jeremy.dale@warwick.ac.uk %K informal carers %K information technology %K internet %K information needs %K mixed methods evaluation %K Reach, Effectiveness, Adoption, Implementation, and Maintenance %K RE-AIM %K mobile phone %D 2023 %7 21.9.2023 %9 Original Paper %J JMIR Aging %G English %X Background: Informal carers play a major role in supporting relatives and friends who are sick, disabled, or frail. Access to information, guidance, and support that are relevant to the lives and circumstances of carers is critical to carers feeling supported in their role. When unmet, this need is known to adversely affect carer resilience and well-being. To address this problem, Care Companion was co-designed with current and former carers and stakeholders as a free-to-use, web-based resource to provide access to a broad range of tailored information, including links to local and national resources. Objective: This study aimed to investigate the real-world uptake and use of Care Companion in 1 region of England (with known carer population of approximately 100,000), with local health, community, and social care teams being asked to actively promote its use. Methods: The study had a convergent parallel, mixed methods design and drew on the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. Data included metrics from carers’ use of Care Companion, surveys completed by users recruited through general practice, and interviews with carers and health and social care providers regarding their views about Care Companion and their response to it. Quantitative data were analyzed using descriptive statistics. Interview data were analyzed thematically and synthesized to create overarching themes. The qualitative findings were used for in-depth exploration and interpretation of quantitative results. Results: Despite awareness-raising activities by relevant health, social care, and community organizations, there was limited uptake with only 556 carers (0.87% of the known carer population of 100,000) registering to use Care Companion in total, with median of 2 (mean 7.2; mode 2) visits per registered user. Interviews with carers (n=29) and stakeholders (n=12) identified 7 key themes that influenced registration, use, and perceived value: stakeholders’ signposting of carers to Care Companion, expectations about Care Companion, activity levels and conflicting priorities, experience of using Care Companion, relevance to personal circumstances, social isolation and networks, and experience with digital technology. Although many interviewed carers felt that it was potentially useful, few considered it as being of direct relevance to their own circumstances. For some, concerns about social isolation and lack of hands-on support were more pressing issues than the need for information. Conclusions: The gap between the enthusiastic views expressed by carers during Care Companion’s co-design and the subsequent low level of uptake and user experience observed in this evaluation suggests that the co-design process may have lacked a sufficiently diverse set of viewpoints. Numerous factors were identified as contributing to Care Companion’s level of use, some of which might have been anticipated during its co-design. More emphasis on the development and implementation, including continuing co-design support after deployment, may have supported increased use. %M 37733406 %R 10.2196/41185 %U https://aging.jmir.org/2023/1/e41185 %U https://doi.org/10.2196/41185 %U http://www.ncbi.nlm.nih.gov/pubmed/37733406 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e49043 %T Blending Video Therapy and Digital Self-Help for Individuals With Suicidal Ideation: Intervention Design and a Qualitative Study Within the Development Process %A Büscher,Rebekka %A Sander,Lasse B %A Nuding,Mattis %A Baumeister,Harald %A Teismann,Tobias %+ Medical Psychology and Medical Sociology, Faculty of Medicine, University of Freiburg, Hebelstr. 29, Freiburg, 79085, Germany, 49 76120395204, rebekka.buescher@mps.uni-freiburg.de %K blended care %K digital interventions %K video therapy %K suicidal ideation %K personalized treatment %K cognitive behavioral therapy %K CBT %K suicide %K suicidal %K digital intervention %K digital health %K video %K web-based module %K blended %K self-help %D 2023 %7 21.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital formats have the potential to enhance accessibility to care for individuals with suicidal ideation. However, digital self-help interventions have faced limitations, including small effect sizes in reducing suicidal ideation, low adherence, and safety concerns. Objective: Therefore, we aimed to develop a remote blended cognitive behavioral therapy intervention that specifically targets suicidal ideation by blending video therapy with web-based self-help modules. The objective of this paper is to describe the collaborative development process and the resulting intervention and treatment rationale. Methods: First, we compiled intervention components from established treatment manuals designed for people with suicidal ideation or behavior, resulting in the development of 11 drafts of web-based modules. Second, we conducted a qualitative study, involving 5 licensed psychotherapists and 3 lay counselors specialized in individuals with suicidal ideation who reviewed these module drafts. Data were collected using the think-aloud method and semistructured interviews, and a qualitative content analysis was performed. The 4 a priori main categories of interest were blended care for individuals with suicidal ideation, contents of web-based modules, usability of modules, and layout. Subcategories emerged inductively from the interview transcripts. Finally, informed by previous treatment manuals and qualitative findings, we developed the remote blended treatment program. Results: The participants suggested that therapists should thoroughly prepare the web-based therapy with patients to tailor the therapy to each individual’s needs. Participants emphasized that the web-based modules should explain concepts in a simple manner, convey empathy and validation, and include reminders for the safety plan. In addition, participants highlighted the need for a simple navigation and layout. Taking these recommendations into account, we developed a fully remote blended cognitive behavioral therapy intervention comprising 12 video therapy sessions and up to 31 web-based modules. The treatment involves collaboratively developing a personalized treatment plan to address individual suicidal drivers. Conclusions: This remote treatment takes advantage of the high accessibility of digital formats while incorporating full sessions with a therapist. In a subsequent pilot trial, we will seek input from individuals with lived experience and therapists to test the feasibility of the treatment. %M 37733414 %R 10.2196/49043 %U https://formative.jmir.org/2023/1/e49043 %U https://doi.org/10.2196/49043 %U http://www.ncbi.nlm.nih.gov/pubmed/37733414 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47178 %T Developing Suicide Prevention Tools in the Context of Digital Peer Support: Qualitative Analysis of a Workshop With Multidisciplinary Stakeholders %A Cliffe,Bethany %A Gore-Rodney,Jessica %A Linton,Myles-Jay %A Biddle,Lucy %+ Population Health Sciences, Bristol Medical School, University of Bristol, Beacon House, Queens Road, Bristol, BS8 1QU, United Kingdom, 44 01179289000, bethany.cliffe@bristol.ac.uk %K digital interventions %K smartphone app %K suicide prevention %K mental health %K mobile phone %D 2023 %7 20.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Suicide is the fourth leading cause of death among young people aged 15-29 years worldwide and suicide rates are increasing. Suicide prevention strategies can be effective but young people face barriers to accessing them. Providing support digitally can facilitate access, but this can also pose risks if there is inappropriate or harmful content. Collaborative approaches are key for developing digital suicide prevention tools to ensure support is appropriate and helpful for young people. Tellmi (previously MeeToo) is a premoderated UK-based peer-support app where people aged 11-25 years can anonymously discuss issues ranging from worries to life challenges. It has procedures to support high-risk users, nevertheless, Tellmi is interested in improving the support they provide to users with more acute mental health needs, such as young people struggling with suicide and self-harm ideation. Further research into the best ways of providing such support for this population is necessary. Objective: The aim of this study is to explore the key considerations for developing and delivering digital suicide prevention tools for young people aged 18-25 years from a multidisciplinary perspective, including the views of young people, practitioners, and academics. Methods: A full-day, in-person workshop was conducted with mental health academics (n=3) and mental health practitioners (n=2) with expertise in suicide prevention, young people with lived experience of suicidal ideation (n=4), and a computer scientist (n=1) and technical staff from the Tellmi app (n=6). Tellmi technical staff presented 14 possible evidence-based adaptations for the app as a basis for the discussions. A range of methods were used to evaluate them, including questionnaires to rate the ideas, annotating printouts of the ideas with post-it notes, and group discussions. A reflexive thematic analysis was performed on the qualitative data to explore key considerations for designing digital suicide prevention tools in the context of peer support. Results: Participants discussed the needs of both those receiving and providing support, noting several key considerations for developing and delivering digital support for high-risk young people. In total, four themes were developed: (1) the aims of the app must be clear and consistent, (2) there are unique considerations for supporting high-risk users: (subtheme) customization helps tailor support to high-risk users, (3) “progress” is a broad and multifaceted concept, and (4) considering the roles of those providing support: (subtheme) expertise required to support app users and (subtheme) mitigating the impact of the role on supporters. Conclusions: This study outlined suggestions that may be beneficial for developing digital suicide prevention tools for young people. Suggestions included apps being customizable, transparent, accessible, visually appealing, and working with users to develop content and language. Future research should further explore this with a diverse group of young people and clinicians. %M 37728967 %R 10.2196/47178 %U https://formative.jmir.org/2023/1/e47178 %U https://doi.org/10.2196/47178 %U http://www.ncbi.nlm.nih.gov/pubmed/37728967 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48899 %T Comparing the Efficacy of an Electronically Delivered Cognitive Behavioral Therapy Program to a Mental Health Check-In Program for Generalized Anxiety Disorder: Protocol for a Randomized Trial %A Stephenson,Callum %A Kumar,Anchan %A Malakouti,Niloufar %A Nikjoo,Niloofar %A Jagayat,Jasleen %A Gizzarelli,Tessa %A Patel,Charmy %A Gutierrez,Gilmar %A Shirazi,Amirhossein %A Yang,Megan %A Omrani,Mohsen %A Alavi,Nazanin %+ Department of Psychiatry, Faculty of Health Sciences, Queen's University, Hotel Dieu Hospital, 166 Brock Street, Kingston, ON, K7L 5G2, Canada, 1 6135443310, nazanin.alavitabari@kingstonhsc.ca %K anxiety %K cognitive behavioral therapy %K eHealth %K electronic care %K generalized anxiety disorder %K internet %K mental health %K psychotherapy %K treatment %K web-based %D 2023 %7 20.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Generalized anxiety disorder (GAD) is a prevalent anxiety disorder, with cognitive behavioral therapy (CBT) being the gold standard treatment. However, it is inaccessible and costly to many, as the mental health industry is overwhelmed by the demand for treatment. This means effective, accessible, and time-saving strategies must be developed to combat these problems. Web-based interventions for mental health disorders are an innovative and promising way to address these barriers. While electronically delivered CBT (e-CBT) has already proved productive and scalable for treating anxiety, other less resource-intensive interventions can be innovated. Checking up on mental health face-to-face has been shown to provide similar benefits to patients with anxiety disorders previously, but more research is needed to evaluate the efficacy of web-based delivery of this intervention. Objective: This study will compare the efficacy of e-CBT and a web-based mental health check-in program to treat GAD. These programs will both be delivered through a secure, web-based care delivery platform. Methods: We will randomly allocate participants (N=100) who are 18 years or older with a confirmed diagnosis of GAD to either an e-CBT program or a mental health check-in program over 12 weeks to address their anxiety symptoms. Participants in the e-CBT arm will complete predesigned modules and homework assignments while receiving personalized feedback and asynchronous interaction with a therapist through the platform. Participants in the mental health check-in arm will be contacted weekly through the web-based platform’s written chat feature (messaging system). Therapists will ask the participants a series of predesigned questions that revolve around a different theme each week to prompt conversation. Using clinically validated questionnaires, the efficacy of the e-CBT arm will be compared to the mental health check-in arm. These questionnaires will be completed at baseline, week 6, and week 12. Results: The study received ethics approval in April 2021, and participant recruitment began in May 2021. Participant recruitment has been conducted through targeted advertisements and physician referrals. Complete data collection and analysis are expected to conclude by August 2023. Linear and binomial regression (continuous and categorical outcomes, respectively) will be conducted. Conclusions: To the research team’s knowledge, this will be the first study to date comparing the efficacy of e-CBT with a web-based mental health check-in program to treat GAD. The findings from this study can help progress the development of more scalable, accessible, and efficacious mental health treatments. Trial Registration: ClinicalTrials.gov NCT04754438; https://classic.clinicaltrials.gov/ct2/show/NCT04754438 International Registered Report Identifier (IRRID): DERR1-10.2196/48899 %M 37587552 %R 10.2196/48899 %U https://www.researchprotocols.org/2023/1/e48899 %U https://doi.org/10.2196/48899 %U http://www.ncbi.nlm.nih.gov/pubmed/37587552 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46847 %T Feasibility of Implementation of a Mobile Digital Personal Health Record to Coordinate Care for Children and Youth With Special Health Care Needs in Primary Care: Protocol for a Mixed Methods Study %A Ming,David Y %A Wong,Willis %A Jones,Kelley A %A Antonelli,Richard C %A Gujral,Nitin %A Gonzales,Sarah %A Rogers,Ursula %A Ratliff,William %A Shah,Nirmish %A King,Heather A %+ Department of Pediatrics, Duke University School of Medicine, 2301 Erwin Rd, DUMC Box 102376, Durham, NC, 27710, United States, 1 9196683093, david.ming@duke.edu %K digital health %K personal health record %K children with special health care needs %K care coordination %K mixed methods %K mobile phone %D 2023 %7 20.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Electronic health record (EHR)–integrated digital personal health records (PHRs) via Fast Healthcare Interoperability Resources (FHIR) are promising digital health tools to support care coordination (CC) for children and youth with special health care needs but remain widely unadopted; as their adoption grows, mixed methods and implementation research could guide real-world implementation and evaluation. Objective: This study (1) evaluates the feasibility of an FHIR-enabled digital PHR app for CC for children and youth with special health care needs, (2) characterizes determinants of implementation, and (3) explores associations between adoption and patient- or family-reported outcomes. Methods: This nonrandomized, single-arm, prospective feasibility trial will test an FHIR-enabled digital PHR app’s use among families of children and youth with special health care needs in primary care settings. Key app features are FHIR-enabled access to structured data from the child’s medical record, families’ abilities to longitudinally track patient- or family-centered care goals, and sharing progress toward care goals with the child’s primary care provider via a clinician dashboard. We shall enroll 40 parents or caregivers of children and youth with special health care needs to use the app for 6 months. Inclusion criteria for children and youth with special health care needs are age 0-16 years; primary care at a participating site; complex needs benefiting from CC; high hospitalization risk in the next 6 months; English speaking; having requisite technology at home (internet access, Apple iOS mobile device); and an active web-based EHR patient portal account to which a parent or caregiver has full proxy access. Digital prescriptions will be used to disseminate study recruitment materials directly to eligible participants via their existing EHR patient portal accounts. We will apply an intervention mixed methods design to link quantitative and qualitative (semistructured interviews and family engagement panels with parents of children and youth with special health care needs) data and characterize implementation determinants. Two CC frameworks (Pediatric Care Coordination Framework; Patient-Centered Medical Home) and 2 evaluation frameworks (Consolidated Framework for Implementation Research; Technology Acceptance Model) provide theoretical foundations for this study. Results: Participant recruitment began in fall 2022, before which we identified >300 potentially eligible patients in EHR data. A family engagement panel in fall 2021 generated formative feedback from family partners. Integrated analysis of pretrial quantitative and qualitative data informed family-centered enhancements to study procedures. Conclusions: Our findings will inform how to integrate an FHIR-enabled digital PHR app for children and youth with special health care needs into clinical care. Mixed methods and implementation research will help strengthen implementation in diverse clinical settings. The study is positioned to advance knowledge of how to use digital health innovations for improving care and outcomes for children and youth with special health care needs and their families. Trial Registration: ClinicalTrials.gov NCT05513235; https://clinicaltrials.gov/study/NCT05513235 International Registered Report Identifier (IRRID): DERR1-10.2196/46847 %M 37728977 %R 10.2196/46847 %U https://www.researchprotocols.org/2023/1/e46847 %U https://doi.org/10.2196/46847 %U http://www.ncbi.nlm.nih.gov/pubmed/37728977 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e43376 %T Refocusing of Attention on Positive Events Using Monitoring-Based Feedback and Microinterventions for Patients With Chronic Musculoskeletal Pain in the PerPAIN Randomized Controlled Trial: Protocol for a Microrandomized Trial %A Ader,Leonie %A Schick,Anita %A Löffler,Martin %A Löffler,Annette %A Beiner,Eva %A Eich,Wolfgang %A Vock,Stephanie %A Sirazitdinov,Andrei %A Malone,Christopher %A Hesser,Jürgen %A Hopp,Michael %A Ruckes,Christian %A Flor,Herta %A Tesarz,Jonas %A Reininghaus,Ulrich %+ Department of Public Mental Health, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, J5, Mannheim, 68159, Germany, 49 62117031930, Ulrich.Reininghaus@zi-mannheim.de %K experience sampling method %K ESM %K ecological momentary intervention %K EMI %K microrandomized trial %K mobile health %K mHealth %K positive intervention %K complex intervention %K mobile phone %D 2023 %7 20.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic musculoskeletal pain (CMSP) affects between 13% and 47% of the population, with a global growth rate of 20.3% within the last 15 years, suggesting that there is a high need for effective treatments. Pain diaries have long been a common tool in nonpharmacological pain treatment for monitoring and providing feedback on patients’ symptoms in daily life. More recently, positive refocusing techniques have come to be used, promoting pain-free episodes and positive outcomes rather than focusing on managing the pain. Objective: This study aims to evaluate the feasibility (ie, acceptability, intervention adherence, and fidelity) and initial signals of efficacy of the PerPAIN app, an ecological momentary intervention for patients with CMSP. The app comprises digitalized monitoring using the experience sampling method (ESM) and feedback. In addition, the patients receive 3 microinterventions targeted at refocusing of attention on positive events. Methods: In a microrandomized trial, we will recruit 35 patients with CMSP who will be offered the app for 12 weeks. Participants will be prompted to fill out 4 ESM monitoring questionnaires a day assessing information on their current context and the proximal outcome variables: absence of pain, positive mood, and subjective activity. Participants will be randomized daily and weekly to receive no feedback, verbal feedback, or visual feedback on proximal outcomes assessed by the ESM. In addition, the app will encourage participants to complete 3 microinterventions based on positive psychology and cognitive behavioral therapy techniques. These microinterventions are prompts to report joyful moments and everyday successes or to plan pleasant activities. After familiarizing themselves with each microintervention individually, participants will be randomized daily to receive 1 of the 3 exercises or none. We will assess whether the 2 feedback types and the 3 microinterventions increase proximal outcomes at the following time point. The microrandomized trial is part of the PerPAIN randomized controlled trial (German Clinical Trials Register DRKS00022792) investigating a personalized treatment approach to enhance treatment outcomes in CMSP. Results: Approval was granted by the Ethics Committee II of the University of Heidelberg on August 4, 2020. Recruitment for the microrandomized trial began in May 2021 and is ongoing at the time of submission. By October 10, 2022, a total of 24 participants had been enrolled in the microrandomized trial. Conclusions: This trial will provide evidence on the feasibility of the PerPAIN app and the initial signals of efficacy of the different intervention components. In the next step, the intervention would need to be further refined and investigated in a definitive trial. This ecological momentary intervention presents a potential method for offering low-level accessible treatment to a wide range of people, which could have substantial implications for public health by reducing disease burden of chronic pain in the population. International Registered Report Identifier (IRRID): DERR1-10.2196/43376 %M 37728983 %R 10.2196/43376 %U https://www.researchprotocols.org/2023/1/e43376 %U https://doi.org/10.2196/43376 %U http://www.ncbi.nlm.nih.gov/pubmed/37728983 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43358 %T The Effects of Dose, Practice Habits, and Objects of Focus on Digital Meditation Effectiveness and Adherence: Longitudinal Study of 280,000 Digital Meditation Sessions Across 103 Countries %A Cearns,Micah %A Clark,Scott R %+ Insight Timer Research, Insight Timer, 64 York Street, Sydney, 2000, Australia, 61 8313 8163, micah@insight.co %K mindfulness %K meditation %K digital meditation %K mindfulness dose-response %K meditation dose-response %K dose-response %K meditation adherence %K mindfulness adherence %K longitudinal meditation research %K outcome %K ecological memory assessment %K mental well-being %K healthy lifestyle %K digital health intervention %D 2023 %7 19.9.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: The efficacy of digital meditation is well established. However, the extent to which the benefits remain after 12 weeks in real-world settings remains unknown. Additionally, findings related to dosage and practice habits have been mixed, and the studies were conducted on small and homogeneous samples and used a limited range of analytical procedures and meditation techniques. Findings related to the predictors of adherence are also lacking and may help inform future meditators and meditation programs on how to best structure healthy sustainable practices. Objective: This study aimed to measure outcome change across a large and globally diverse population of meditators and meditations in their naturalistic practice environments, assess the dose-response relationships between practice habits and outcome change, and identify predictors of adherence. Methods: We used ecological momentary assessment to assess participants’ well-being over a 14-month period. We engineered outcomes related to the variability of change over time (equanimity) and recovery following a drop in mood (resilience) and established the convergent and divergent validity of these outcomes using a validated scale. Using linear mixed-effects and generalized additive mixed-effects models, we modeled outcome changes and patterns of dose-response across outcomes. We then used logistic regression to study the practice habits of participants in their first 30 sessions to derive odds ratios of long-term adherence. Results: Significant improvements were observed in all outcomes (P<.001). Generalized additive mixed models revealed rapid improvements over the first 50-100 sessions, with further improvements observed until the end of the study period. Outcome change corresponded to 1 extra day of improved mood for every 5 days meditated and half-a-day-faster mood recovery compared with baseline. Overall, consistency of practice was associated with the largest outcome change (4-7 d/wk). No significant differences were observed across session lengths in linear models (mood: P=.19; equanimity: P=.10; resilience: P=.29); however, generalized additive models revealed significant differences over time (P<.001). Longer sessions (21-30 min) were associated with the largest magnitude of change in mood from the 20th session onward and fewer sessions to recovery (increased resilience); midlength sessions (11-20 min) were associated with the largest decreases in recovery; and mood stability was similar across session lengths (equanimity). Completing a greater variety of practice types was associated with significantly greater improvements across all outcomes. Adhering to a long-term practice was best predicted by practice consistency (4-7 d/wk), a morning routine, and maintaining an equal balance between interoceptive and exteroceptive meditations. Conclusions: Long-term real-world digital meditation practice is effective and associated with improvements in mood, equanimity, and resilience. Practice consistency and variety rather than length best predict improvement. Long-term sustainable practices are best predicted by consistency, a morning routine, and a practice balanced across objects of focus that are internal and external to the body. %M 37725801 %R 10.2196/43358 %U https://www.jmir.org/2023/1/e43358 %U https://doi.org/10.2196/43358 %U http://www.ncbi.nlm.nih.gov/pubmed/37725801 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46396 %T Digital Health Implementation Strategies Coproduced With Adults With Acquired Brain Injury, Their Close Others, and Clinicians: Mixed Methods Study With Collaborative Autoethnography and Network Analysis %A Miao,Melissa %A Morrow,Rosemary %A Salomon,Alexander %A Mcculloch,Ben %A Evain,Jean-Christophe %A Wright,Meg Rebecca %A Murphy,Marie Therese %A Welsh,Monica %A Williams,Liz %A Power,Emma %A Rietdijk,Rachael %A Debono,Deborah %A Brunner,Melissa %A Togher,Leanne %+ Graduate School of Health, Faculty of Health, University of Technology Sydney, 100 Broadway, Sydney, Australia, 61 2 9514 1448, melissa.miao@uts.edu.au %K complexity %K implementation science %K internet interventions %K brain injury %K stroke %K traumatic brain injury %K delivery of health care %K caregivers %K digital health %K psychosocial interventions %K psychosocial %K mobile phone %D 2023 %7 19.9.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Acquired brain injuries (ABIs), such as stroke and traumatic brain injury, commonly cause cognitive-communication disorders, in which underlying cognitive difficulties also impair communication. As communication is an exchange with others, close others such as family and friends also experience the impact of cognitive-communication impairment. It is therefore an internationally recommended best practice for speech-language pathologists to provide communication support to both people with ABI and the people who communicate with them. Current research also identifies a need for neurorehabilitation professionals to support digital communication, such as social media use, after ABI. However, with >135 million people worldwide affected by ABI, alternate and supplementary service delivery models are needed to meet these communication needs. The “Social Brain Toolkit” is a novel suite of 3 interventions to deliver communication rehabilitation via the internet. However, digital health implementation is complex, and minimal guidance exists for ABI. Objective: This study aimed to support the implementation of the Social Brain Toolkit by coproducing implementation knowledge with people with ABI, people who communicate with people with ABI, clinicians, and leaders in digital health implementation. Methods: A maximum variation sample (N=35) of individuals with living experience of ABI, close others, clinicians, and digital health implementation leaders participated in an explanatory sequential mixed methods design. Stakeholders quantitatively prioritized 4 of the 7 theoretical domains of the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework as being the most important for Social Brain Toolkit implementation. Qualitative interview and focus group data collection focused on these 4 domains. Data were deductively analyzed against the NASSS framework with stakeholder coauthors to determine implementation considerations and strategies. A collaborative autoethnography of the research was conducted. Interrelationships between considerations and strategies were identified through a post hoc network analysis. Results: Across the 4 prioritized domains of “condition,” “technology,” “value proposition,” and “adopters,” 48 digital health implementation considerations and 52 tailored developer and clinician implementation strategies were generated. Benefits and challenges of coproduction were identified. The post hoc network analysis revealed 172 unique relationships between the identified implementation considerations and strategies, with user and persona testing and responsive design identified as the potentially most impactful strategies. Conclusions: People with ABI, close others, clinicians, and digital health leaders coproduced new knowledge of digital health implementation considerations for adults with ABI and the people who communicate with them, as well as tailored implementation strategies. Complexity-informed network analyses offered a data-driven method to identify the 2 most potentially impactful strategies. Although the study was limited by a focus on 4 NASSS domains and the underrepresentation of certain demographics, the wealth of actionable implementation knowledge produced supports future coproduction of implementation research with mutually beneficial outcomes for stakeholders and researchers. International Registered Report Identifier (IRRID): RR2-10.2196/35080 %M 37725413 %R 10.2196/46396 %U https://www.jmir.org/2023/1/e46396 %U https://doi.org/10.2196/46396 %U http://www.ncbi.nlm.nih.gov/pubmed/37725413 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45540 %T The Use of Mobile Assessments for Monitoring Mental Health in Youth: Umbrella Review %A Marciano,Laura %A Vocaj,Emanuela %A Bekalu,Mesfin A %A La Tona,Antonino %A Rocchi,Giulia %A Viswanath,Kasisomayajula %+ Lee Kum Sheung Center for Health and Happiness, Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA, 02115, United States, 1 6175828025, lmarciano@hsph.harvard.edu %K mobile assessment %K ecological momentary assessments %K EMAs %K digital phenotyping %K umbrella review %K youth %K mental health %K mobile phone %D 2023 %7 19.9.2023 %9 Review %J J Med Internet Res %G English %X Background: Improving mental health in youth is a major concern. Future approaches to monitor and intervene in youth mental health problems should rely on mobile tools that allow for the daily monitoring of mental health both actively (eg, using ecological momentary assessments [EMAs]) and passively (eg, digital phenotyping) by capturing individuals’ data. Objective: This umbrella review aims to (1) report the main characteristics of existing reviews on mental health and young people, including mobile approaches to mental health; (2) describe EMAs and trace data and the mental health conditions investigated; (3) report the main results; and (4) outline promises, limitations, and directions for future research. Methods: A systematic literature search was carried out in 9 scientific databases (Communication & Mass Media Complete, Psychology and Behavioral Sciences Collection, PsycINFO, CINAHL, ERIC, MEDLINE, the ProQuest Sociology Database, Web of Science, and PubMed) on January 30, 2022, coupled with a hand search and updated in July 2022. We included (systematic) reviews of EMAs and trace data in the context of mental health, with a specific focus on young populations, including children, adolescents, and young adults. The quality of the included reviews was evaluated using the AMSTAR (Assessment of Multiple Systematic Reviews) checklist. Results: After the screening process, 30 reviews (published between 2016 and 2022) were included in this umbrella review, of which 21 (70%) were systematic reviews and 9 (30%) were narrative reviews. The included systematic reviews focused on symptoms of depression (5/21, 24%); bipolar disorders, schizophrenia, or psychosis (6/21, 29%); general ill-being (5/21, 24%); cognitive abilities (2/21, 9.5%); well-being (1/21, 5%); personality (1/21, 5%); and suicidal thoughts (1/21, 5%). Of the 21 systematic reviews, 15 (71%) summarized studies that used mobile apps for tracing, 2 (10%) summarized studies that used them for intervention, and 4 (19%) summarized studies that used them for both intervention and tracing. Mobile tools used in the systematic reviews were smartphones only (8/21, 38%), smartphones and wearable devices (6/21, 29%), and smartphones with other tools (7/21, 33%). In total, 29% (6/21) of the systematic reviews focused on EMAs, including ecological momentary interventions; 33% (7/21) focused on trace data; and 38% (8/21) focused on both. Narrative reviews mainly focused on the discussion of issues related to digital phenotyping, existing theoretical frameworks used, new opportunities, and practical examples. Conclusions: EMAs and trace data in the context of mental health assessments and interventions are promising tools. Opportunities (eg, using mobile approaches in low- and middle-income countries, integration of multimodal data, and improving self-efficacy and self-awareness on mental health) and limitations (eg, absence of theoretical frameworks, difficulty in assessing the reliability and effectiveness of such approaches, and need to appropriately assess the quality of the studies) were further discussed. Trial Registration: PROSPERO CRD42022347717; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=347717 %M 37725422 %R 10.2196/45540 %U https://www.jmir.org/2023/1/e45540 %U https://doi.org/10.2196/45540 %U http://www.ncbi.nlm.nih.gov/pubmed/37725422 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 6 %N %P e47691 %T Web-Based Cognitive Behavioral Therapy for Depression Among Homebound Older Adults: Development and Usability Study %A Xiang,Xiaoling %A Kayser,Jay %A Ash,Samson %A Zheng,Chuxuan %A Sun,Yihang %A Weaver,Addie %A Dunkle,Ruth %A Blackburn,James A %A Halavanau,Alex %A Xue,Jia %A Himle,Joseph A %+ School of Social Work, University of Michigan-Ann Arbor, 1080 S University Avenue, Ann Arbor, MI, 48109, United States, 1 7347636581, xiangxi@umich.edu %K internet-based cognitive behavioral therapy %K usability %K geriatric depression %K community-engaged research %K web-based %K geriatrics %K geriatric %K depression %K psychotherapy %K mental health %K older adults %K older adult %K cognitive behavioral therapy %K CBT %K design %K development %K community %K user centered design %K digital health %K aging %K old age %K digital mental health %K web-based health %K internet %D 2023 %7 19.9.2023 %9 Original Paper %J JMIR Aging %G English %X Background: Homebound older adults are a high-risk group for depression. However, many of them face barriers to accessing evidence-supported mental health treatments. Digital mental health interventions can potentially improve treatment access, but few web-based interventions are explicitly tailored for depression in older adults. Objective: This paper describes the development process of Empower@Home, a web-delivered intervention for depression in homebound older adults that is based on cognitive behavioral therapy, and reports on the outcomes of usability studies. Methods: Empower@Home was developed in collaboration with community agencies, stakeholders, and older adults, guided by user-centered design principles. User needs were assessed through secondary data analysis, demographic and health profiles from administrative data, and interviews and surveys of community partners. A comparative usability evaluation was conducted with 10 older adults to assess the usability of Empower@Home compared to 2 similar programs. Field testing was conducted with 4 end users to detect additional usability issues. Results: Feedback and recommendations from community partners heavily influenced the content and design of Empower@Home. The intervention consists of 9 sessions, including psychoeducation and an introduction to cognitive behavioral therapy skills and tools through short video clips, in-session exercises, an animated storyline, and weekly out-of-session home practice. A printed workbook accompanies the web-based lessons. In comparative usability testing (N=10), Empower@Home received a System Usability Scale score of 78 (SD 7.4), which was significantly higher than the 2 comparator programs (t9=3.28; P=.005 and t9=2.78; P=.011). Most participants, 80% (n=8), preferred Empower@Home over the comparators. In the longitudinal field test (n=4), all participants reported liking the program procedures and feeling confident in performing program-related tasks. The single-subject line graph showed an overall downward trend in their depression scores over time, offering an encouraging indication of the intervention’s potential effects. Conclusions: Collaboration with community stakeholders and careful consideration of potential implementation issues during the design process can result in more usable, engaging, and effective digital mental health interventions. %M 37725423 %R 10.2196/47691 %U https://aging.jmir.org/2023/1/e47691 %U https://doi.org/10.2196/47691 %U http://www.ncbi.nlm.nih.gov/pubmed/37725423 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e48719 %T Digital Cognitive Behavioral- and Mindfulness-Based Stress-Management Interventions for Survivors of Breast Cancer: Development Study %A Børøsund,Elin %A Meland,Anders %A Eriksen,Hege R %A Rygg,Christine M %A Ursin,Giske %A Solberg Nes,Lise %+ Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Pb 4950 Nydalen, Oslo, 0424, Norway, 47 92667161, elin.borosund@rr-research.no %K cancer %K stress management %K mindfulness %K cognitive behavioral therapy %K digital %K eHealth %K mHealth %K app %K user-driven development %K usability %D 2023 %7 19.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Psychosocial stress-management interventions can reduce stress and distress and improve the quality of life for survivors of cancer. As these in-person interventions are not always offered or accessible, evidence-informed digital stress-management interventions may have the potential to improve outreach of psychosocial support for survivors of cancer. Few such digital interventions exist so far, few if any have been developed specifically for survivors of breast cancer, and few if any have attempted to explore more than 1 distinct type of intervention framework. Objective: This study aimed to develop 2 digital psychosocial stress-management interventions for survivors of breast cancer; 1 cognitive behavioral therapy-based intervention (CBI), and 1 mindfulness-based intervention (MBI). Methods: The development of the CBI and MBI interventions originated from the existing StressProffen program, a digital stress-management intervention program for survivors of cancer, based on a primarily cognitive behavioral therapeutic concept. Development processes entailed a multidisciplinary design approach and were iteratively conducted in close collaboration between key stakeholders, including experts within psychosocial oncology, cancer epidemiology, stress-management, and eHealth as well as survivors of breast cancer and health care providers. Core psychosocial oncology stress-management and cancer epidemiology experts first conducted a series of workshops to identify cognitive behavioral and mindfulness specific StressProffen content, overlapping psychoeducational content, and areas where development and incorporation of new material were needed. Following the program content adaptation and development phase, phases related to user testing of new content and technical, privacy, security, and ethical aspects and adjustments ensued. Intervention content for the distinct CBI and MBI interventions was refined in iterative user-centered design processes and adjusted to electronic format through stakeholder-centered iterations. Results: For the CBI version, the mindfulness-based content of the original StressProffen was removed, and for the MBI version, cognitive behavioral content was removed. Varying degrees of new content were created for both versions, using a similar layout as for the original StressProffen program. New content and new exercises in particular were tested by survivors of breast cancer and a project-related editorial team, resulting in subsequent user centered adjustments, including ensuring auditory versions and adequate explanations before less intuitive sections. Other improvements included implementing a standard closing sentence to round off every exercise, and allowing participants to choose the length of some of the mindfulness exercises. A legal disclaimer and a description of data collection, user rights and study contact information were included to meet ethical, privacy, and security requirements. Conclusions: This study shows how theory specific (ie, CBI and MBI) digital stress-management interventions for survivors of breast cancer can be developed through extensive collaborations between key stakeholders, including scientists, health care providers, and survivors of breast cancer. Offering a variety of evidence-informed stress-management approaches may potentially increase interest for outreach and impact of psychosocial interventions for survivors of cancer. International Registered Report Identifier (IRRID): RR2-10.2196/47195 %M 37725424 %R 10.2196/48719 %U https://formative.jmir.org/2023/1/e48719 %U https://doi.org/10.2196/48719 %U http://www.ncbi.nlm.nih.gov/pubmed/37725424 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47811 %T Opening the Black Box of an mHealth Patient-Reported Outcome Tool for Diabetes Self-Management: Interview Study Among Patients With Type 2 Diabetes %A Marini,Christina %A Cruz,Jocelyn %A Payano,Leydi %A Flores,Ronaldo Patino %A Arena,Gina-Maria %A Mandal,Soumik %A Leven,Eric %A Mann,Devin %A Schoenthaler,Antoinette %+ Department of Neurology, NYU Langone, 222 East 41st Street, New York, NY, 10017, United States, 1 9738651627, christina.marini@nyulangone.org %K mobile health %K mHealth %K patient-reported outcomes %K diabetes %K qualitative %K patient engagement %D 2023 %7 19.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Mobile health (mHealth) tools are used to collect data on patient-reported outcomes (PROs) and facilitate the assessment of patients’ self-management behaviors outside the clinic environment. Despite the high availability of mHealth diabetes tools, there is a lack of understanding regarding the underlying reasons why these mHealth PRO tools succeed or fail in terms of changing patients’ self-management behaviors. Objective: This study aims to identify the factors that drive engagement with an mHealth PRO tool and facilitate patients’ adoption of self-management behaviors, as well as elicit suggestions for improvement. Methods: This qualitative study was conducted within the context of a randomized controlled trial designed to evaluate the efficacy of an mHealth PRO tool (known as i-Matter) versus usual care regarding reduction in glycated hemoglobin (HbA1c) levels and adherence to self-management behaviors at 12 months among patients with uncontrolled type 2 diabetes. Patients randomized to i-Matter participated in semistructured interviews about their experiences at the 3-, 6-, 9-, and 12-month study visits. A qualitative analysis of the interviews was conducted by 2 experienced qualitative researchers using conventional qualitative content analysis. Results: The sample comprised 71 patients, of whom 67 (94%) completed at least one interview (n=48, 72% female patients; n=25, 37% identified as African American or Black; mean age 56.65 [SD 9.79] years). We identified 4 overarching themes and 6 subthemes. Theme 1 showed that the patients’ reasons for engagement with i-Matter were multifactorial. Patients were driven by internal motivating factors that bolstered their engagement and helped them feel accountable for their diabetes (subtheme 1) and external motivating factors that helped to serve as reminders to be consistent with their self-management behaviors (subtheme 2). Theme 2 revealed that the use of i-Matter changed patients’ attitudes toward their disease and their health behaviors in 2 ways: patients developed more positive attitudes about their condition and their ability to effectively self-manage it (subtheme 3), and they also developed a better awareness of their current behaviors, which motivated them to adopt healthier lifestyle behaviors (subtheme 4). Theme 3 showed that patients felt more committed to their health as a result of using i-Matter. Theme 4 highlighted the limitations of i-Matter, which included its technical design (subtheme 5) and the need for more resources to support the PRO data collected and shared through the tool (subtheme 6). Conclusions: This study isolated internal and external factors that prompted patients to change their views about their diabetes, become more engaged with the intervention and their health, and adopt healthy behaviors. These behavioral mechanisms provide important insights to drive future development of mHealth interventions that could lead to sustained behavior change. %M 37725427 %R 10.2196/47811 %U https://formative.jmir.org/2023/1/e47811 %U https://doi.org/10.2196/47811 %U http://www.ncbi.nlm.nih.gov/pubmed/37725427 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49828 %T Guided Internet-Based Cognitive Behavioral Therapy for Women With Bulimia Nervosa: Protocol for a Multicenter Randomized Controlled Trial %A Hamatani,Sayo %A Matsumoto,Kazuki %A Andersson,Gerhard %A Tomioka,Yukiko %A Numata,Shusuke %A Kamashita,Rio %A Sekiguchi,Atsushi %A Sato,Yasuhiro %A Fukudo,Shin %A Sasaki,Natsuki %A Nakamura,Masayuki %A Otani,Ryoko %A Sakuta,Ryoichi %A Hirano,Yoshiyuki %A Kosaka,Hirotaka %A Mizuno,Yoshifumi %+ Research Center for Child Mental Development, University of Fukui, 23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, 910-1193, Japan, 81 776 61 3111, sayoh@u-fukui.ac.jp %K bulimia nervosa %K internet-based cognitive behavioral therapy %K ICBT %K randomized controlled trial %K RCT %K protocol %K randomized %K controlled trial %K bulimia %K eating %K cognitive behavioral therapy %K CBT %K binge eating %K purging %K mobile phone %D 2023 %7 19.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Individual face-to-face cognitive behavioral therapy is known to be effective for bulimia nervosa (BN). Since foods vary considerably between regions and cultures in which patients live, cultural adaptation of the treatment program is particularly important in cognitive behavioral therapy for BN. Recently, an internet-based cognitive behavioral therapy (ICBT) program was developed for Japanese women with BN, adapted to the Japanese food culture. However, no previous randomized controlled trial has examined the effectiveness of ICBT. Objective: This paper presents a research protocol for strategies to examine the effects of guided ICBT. Methods: This study is designed as a multicenter, prospective, assessor-blinded randomized controlled trial. The treatment groups will be divided into treatment as usual (TAU) alone as the control group and ICBT combined with TAU as the intervention group. The primary outcome is the total of binge eating and purging behaviors assessed before and after treatment by an independent assessor. Secondary outcomes will include measures of eating disorder severity, depression, anxiety, quality of life, treatment satisfaction, and working alliances. Treatment satisfaction and working alliances will be measured post assessment only. Other measures will be assessed at baseline, post intervention, and follow-up, and the outcomes will be analyzed on an intention-to-treat basis. Results: This study will be conducted at 7 different medical institutions in Japan from August 2022 to October 2026. Recruitment of participants began on August 19, 2022, and recruitment is scheduled to continue until July 2024. The first participants were registered on September 8, 2022. Conclusions: This is the first multicenter randomized controlled trial in Japan comparing the effectiveness of ICBT and TAU in patients with BN. Trial Registration: University Hospital Medical Information Network UMIN000048732; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055522 International Registered Report Identifier (IRRID): DERR1-10.2196/49828 %M 37725414 %R 10.2196/49828 %U https://www.researchprotocols.org/2023/1/e49828 %U https://doi.org/10.2196/49828 %U http://www.ncbi.nlm.nih.gov/pubmed/37725414 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47137 %T MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial %A Mulawa,Marta I %A Hoare,Jacqueline %A Knippler,Elizabeth T %A Mtukushe,Bulelwa %A Matiwane,Mluleki %A Muessig,Kathryn E %A Al-Mujtaba,Maryam %A Wilkinson,T Harper %A Platt,Alyssa %A Egger,Joseph R %A Hightow-Weidman,Lisa B %+ School of Nursing, Duke University, DUMC 3322, 307 Trent Drive, Durham, NC, 27710, United States, 1 (919) 6849555, marta.mulawa@duke.edu %K HIV %K adherence %K mHealth %K digital health %K smartphone %K adolescents and young adults %K youths %K South Africa %K social support %K randomized %K controlled trial %K pilot %K antiretroviral therapy %K sexually transmitted %K app %K apps %K mobile phone %D 2023 %7 19.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adolescents and young adults with HIV repeatedly demonstrate low rates of antiretroviral therapy (ART) adherence as well as low rates of viral suppression. Digital health interventions are a promising way to engage adolescents and young adults with HIV to support ART adherence. However, few digital health interventions have been developed and tested with adolescents and young adults in countries like South Africa, where the HIV burden among adolescents and young adults is greatest. Masakhane Siphucule Impilo Yethu (MASI; Xhosa for “Let's empower each other and improve our health”) is a comprehensive ART adherence-supporting app for South African adolescents and young adults with HIV. It was culturally adapted using the HealthMpowerment platform. Objective: The aim of this paper is to describe the protocol for a pilot randomized controlled trial examining the feasibility, acceptability, and preliminary efficacy of MASI on self-reported ART adherence and social support. Methods: We will enroll 50 adolescents and young adults with HIV ages 15-21 years. Participants will be recruited from public ART clinics linked to a large government-funded teaching hospital in Cape Town, South Africa. Participants will be randomized 1:1 into either the intervention arm receiving a full version of MASI or the control arm receiving an information-only version of the app (n=25 per arm). Participants will be asked to engage with MASI daily for 6 months. All participants will complete baseline and follow-up assessments at 3 and 6 months. Results: Study screening began in May 2022 and the first participant was enrolled on June 21, 2022. As of June 12, 2023, 81 participants have completed screeners, and 36 eligible participants have been enrolled in the pilot randomized controlled trial. Recruitment is anticipated to last through August 31, 2023, with study activities anticipated through February 29, 2024. Conclusions: There is an urgent need for innovative interventions to improve ART adherence among adolescents and young adults in settings like South Africa. If found to be feasible and acceptable, MASI could be implemented with adolescents and young adults with HIV in other parts of the country. Trial Registration: ClinicalTrials.gov NCT04661878; https://clinicaltrials.gov/ct2/show/study/NCT04661878 International Registered Report Identifier (IRRID): DERR1-10.2196/47137 %M 37725409 %R 10.2196/47137 %U https://www.researchprotocols.org/2023/1/e47137 %U https://doi.org/10.2196/47137 %U http://www.ncbi.nlm.nih.gov/pubmed/37725409 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47059 %T e–Mental Health Program to Prevent Psychological Distress Among French-Speaking International Students in a Linguistic-Cultural Minority Context (Ottawa, Alberta, and Quebec): Protocol for the Implementation and Evaluation of Psy-Web %A Beogo,Idrissa %A Ramdé,Jean %A Anne,Abdoulaye %A Gagnon,Marie-Pierre %A Sia,Drissa %A Nguemeleu Tchouaket,Eric %+ Faculty of Health Sciences, School of Nursing, University of Ottawa, Room 420F, 200, Lees Avenue, Ottawa, ON, K1N 6N5, Canada, 1 613 562 5800, ibeogo@uottawa.ca %K international students %K psychological distress %K Covid-19 pandemic %K web-based %K internet-based %K peer support %K distress %K loneliness %K isolation %K isolated %K psychological %K student %K students %K immigrant %K immigrants %K foreign %K social interaction %K French %K design %K develop %K development %D 2023 %7 19.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Based on experiences with the COVID-19 pandemic, postsecondary institutions were most affected by the restrictions. Students, especially international students, have borne the brunt associated with in-person learning restrictions imposed by public health recommendations. Canada is among the top 3 countries hosting international students (ISs), including Francophone students in provinces such as Quebec and other anglophone regions. Academic restrictions were accompanied by other measures such as quarantine, self-isolation, social distancing, and travel ban, to cite some. This has had a wide-ranging impact on these ISs. The resulting psychological distress and burden may have a much greater impact on Francophone ISs in anglophone settings, many of whom had ordinarily limited access to active offers of care in French in addition to cultural barriers and low literacy of the health care system. In order to take advantage of the effectiveness of eHealth as a pertinent and promising avenue, our project intends to build a web-based application that is cost-effective, user-friendly, anonymous, and capable to prompt interactive interventions as a first-line resource for psychological distress. In fact, internet applications have been increasingly used for the management of psychological distresses, and internet-based cognitive behavioral therapy is one of the preferred methods to prevent or control them. Objective: The aims of this study are to (1) design, implement, and maintain Psy-Web for the psychological support of ISs and (2) analyze the results of the implementation of the Psy-Web platform, the additional resources solicited, and the results obtained. Methods: This interventional project will use a sequential mixed design in the exploratory phase (phase 1) including the construction of the Psy-Web platform. A quantitative prospective component (phase 2) will include the intervention content of the Psy-Web platform. In total, 105 ISs participants (study group) and 52 ISs (control group), based on a ratio of 1:2, will be considered. The control group participants include those who did not use the web platform. Results: The project is at the data collection stage (phase 1). Psy-Web will be built in accordance with the DMAIC (Define, Measure, Analyze, Improve and Control) model with the perspective of boosting its robustness. As a first-line resource to prevent psychological distress and ultimately improve their academic performance, Psy-Web is an innovative opportunity for high education managers. The project involves a multisectoral and a multidisciplinary partnership. Conclusions: The project will develop a promising web-based solution to prevent psychological distress. Ultimately, Psy-Web will be operable in multiple languages including French. International Registered Report Identifier (IRRID): PRR1-10.2196/47059 %M 37725428 %R 10.2196/47059 %U https://www.researchprotocols.org/2023/1/e47059 %U https://doi.org/10.2196/47059 %U http://www.ncbi.nlm.nih.gov/pubmed/37725428 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e48157 %T Long-Term Outcomes of a Comprehensive Mobile Smoking Cessation Program With Nicotine Replacement Therapy in Adult Smokers: Pilot Randomized Controlled Trial %A Marler,Jennifer D %A Fujii,Craig A %A Utley,MacKenzie T %A Balbierz,Daniel J %A Galanko,Joseph A %A Utley,David S %+ Pivot Health Technologies, Inc, 1010 Commercial St., Suite C, San Carlos, CA, 94070, United States, 1 4082145545, marler@pivot.co %K smoking cessation %K digital health %K smartphone %K digital sensor %K carbon monoxide %K breath sensor %K biofeedback %K mobile apps %K health promotion %K app %K mobile phone %D 2023 %7 18.9.2023 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Increased smartphone ownership has led to the development of mobile smoking cessation programs. Although the related body of evidence, gathered through the conduct of randomized controlled trials (RCTs), has grown in quality and rigor, there is a need for longer-term data to assess associated smoking cessation durability. Objective: The primary aim was to compare smoking cessation outcomes at 52 weeks in adult smokers randomized to a mobile smoking cessation program, Pivot (intervention), versus QuitGuide (control). The secondary aims included comparison of other smoking-related behaviors, outcomes and participant feedback, and exploratory analyses of baseline factors associated with smoking cessation. Methods: In this remote pilot RCT, cigarette smokers in the United States were recruited on the web. Participants were offered 12 weeks of free nicotine replacement therapy (NRT). Data were self-reported via a web-based questionnaire with videoconference biovalidation in participants who reported 7-day point-prevalence abstinence (PPA). Outcomes focused on cessation rates with additional assessment of quit attempts, cigarettes per day (CPD), self-efficacy via the Smoking Abstinence Self-Efficacy Questionnaire, NRT use, and participant feedback. Cessation outcomes included self-reported 7- and 30-day PPA, abstinence from all tobacco products, and continuous abstinence. PPA and continuous abstinence were biovalidated using witnessed breath carbon monoxide samples. Exploratory post hoc regression analyses were performed to identify baseline variables associated with smoking cessation. Results: Participants comprised 188 smokers (n=94, 50% in the Pivot group and n=94, 50% in the QuitGuide group; mean age 46.4, SD 9.2 years; n=104, 55.3% women; n=128, 68.1% White individuals; mean CPD 17.6, SD 9.0). Several cessation rates were higher in the Pivot group (intention to treat): self-reported continuous abstinence was 20% (19/94) versus 9% (8/94; P=.03) for QuitGuide, biochemically confirmed abstinence was 31% (29/94) versus 18% (17/94; P=.04) for QuitGuide, and biochemically confirmed continuous abstinence was 19% (18/94) versus 9% (8/94; P=.046) for QuitGuide. More Pivot participants (93/94, 99% vs 80/94, 85% in the QuitGuide group; P<.001) placed NRT orders (mean 3.3, SD 2.0 vs 1.8, SD 1.6 for QuitGuide; P<.001). Pivot participants had increased self-efficacy via the Smoking Abstinence Self-Efficacy Questionnaire (mean point increase 3.2, SD 7.8, P<.001 vs 1.0, SD 8.5, P=.26 for QuitGuide). QuitGuide participants made more mean quit attempts (7.0, SD 6.3 for Pivot vs 9.5, SD 7.5 for QuitGuide; P=.01). Among those who did not achieve abstinence, QuitGuide participants reported greater CPD reduction (mean −34.6%, SD 35.5% for Pivot vs −46.1%, SD 32.3% for QuitGuide; P=.04). Among those who reported abstinence, 90% (35/39) of Pivot participants and 90% (26/29) of QuitGuide participants indicated that their cessation program helped them quit. Conclusions: This pilot RCT supports the long-term effectiveness of the Pivot mobile smoking cessation program, with abstinence rates durable to 52 weeks. Trial Registration: ClinicalTrials.gov NCT04955639; https://clinicaltrials.gov/ct2/show/NCT04955639 %M 37585282 %R 10.2196/48157 %U https://mhealth.jmir.org/2023/1/e48157 %U https://doi.org/10.2196/48157 %U http://www.ncbi.nlm.nih.gov/pubmed/37585282 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45510 %T A Series of Personalized Virtual Light Therapy Interventions for Fatigue: Feasibility Randomized Crossover Trial for N-of-1 Treatment %A Butler,Mark %A D’Angelo,Stefani %A Ahn,Heejoon %A Chandereng,Thevaa %A Miller,Danielle %A Perrin,Alexandra %A Romain,Anne-Marie N %A Scatoni,Ava %A Friel,Ciaran P %A Cheung,Ying-Kuen %A Davidson,Karina W %+ Institute of Health System Science, Feinstein Institutes for Medical Research, Northwell Health, 130 East 59th Street, Suite 14C, New York, NY, 10022, United States, 1 9084140238, markbutler@northwell.edu %K virtual light therapy interventions %K fatigue %K light therapy %K primary care %K feasibility %K acceptability %K effectiveness %K usability %K seasonal affective disorder %K phototherapy %K photoradiation %K photochemotherapy %K color therapy %K heliotherapy %K photothermal therapy %K UV therapy %K chromotherapy %K color light therapy %K mobile phone %D 2023 %7 18.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Fatigue is one of the most common symptoms treated in primary care and can lead to deficits in mental health and functioning. Light therapy can be an effective treatment for symptoms of fatigue; however, the feasibility, scalability, and individual-level heterogeneity of light therapy for fatigue are unknown. Objective: This study aimed to evaluate the feasibility, acceptability, and effectiveness of a series of personalized (N-of-1) interventions for the virtual delivery of bright light (BL) therapy and dim light (DL) therapy versus usual care (UC) treatment for fatigue in 60 participants. Methods: Participants completed satisfaction surveys comprising the System Usability Scale (SUS) and items assessing satisfaction with the components of the personalized trial. Symptoms of fatigue were measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) daily, PROMIS weekly, and ecological momentary assessment (EMA) questionnaires delivered 3 times daily. Comparisons of fatigue between the BL, DL, and UC treatment periods were conducted using generalized linear mixed model analyses between participants and generalized least squares analyses within individual participants. Results: Participants rated the usability of the personalized trial as acceptable (average SUS score=78.9, SD 15.6), and 92% (49/53) of those who completed satisfaction surveys stated that they would recommend the trial to others. The levels of fatigue symptoms measured using the PROMIS daily fatigue measure were lower or improved in the BL (B=−1.63, 95% CI −2.63 to −0.63) and DL (B=−1.44, 95% CI −2.50 to −0.38) periods relative to UC. The treatment effects of BL and DL on the PROMIS daily measure varied among participants. Similar findings were demonstrated for the PROMIS weekly and EMA measures of fatigue symptoms. Conclusions: The participant scores on the SUS and satisfaction surveys suggest that personalized N-of-1 trials of light therapy for fatigue symptoms are both feasible and acceptable. Both interventions produced significant (P<.05) reductions in participant-reported PROMIS and EMA fatigue symptoms relative to UC. However, the heterogeneity of these treatment effects across participants indicated that the effect of light therapy was not uniform. This heterogeneity along with high ratings of usability and satisfaction support the use of personalized N-of-1 research designs in evaluating the effect of light therapy on fatigue for each patient. Furthermore, the results of this trial provide additional support for the use of a series of personalized N-of-1 research trials. Trial Registration: ClinicalTrials.gov NCT04707846; https://clinicaltrials.gov/ct2/show/NCT04707846 %M 37721795 %R 10.2196/45510 %U https://formative.jmir.org/2023/1/e45510 %U https://doi.org/10.2196/45510 %U http://www.ncbi.nlm.nih.gov/pubmed/37721795 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e51431 %T A Complex mHealth Coaching Intervention to Prevent Overweight, Obesity, and Diabetes in High-Risk Women in Antenatal Care: Protocol for a Hybrid Type 2 Effectiveness-Implementation Study %A O'Reilly,Sharleen L %A Laws,Rachel %A Maindal,Helle Terkildsen %A Teede,Helena %A Harrison,Cheryce %A McAuliffe,Fionnuala M %A Geraghty,Aisling %A Campoy,Cristina %A Bermúdez,Mercedes G %A Pirhonen,Laura %A Burden,Christy %A Davies,Anna %A Laursen,Ditte Hjorth %A Skinner,Timothy %A , %+ School of Agriculture and Food Science, University College Dublin, School of Agriculture and Food Science, University College Dublin, Belfield, Dublin, D4, Ireland, 353 17162157, sharleen.oreilly@ucd.ie %K hybrid type 2 effectiveness-implementation %K gestational diabetes %K obesity %K mHealth %K mobile health %K health behavior change %K pregnancy %K postpartum %K weight management %K health coaching %K maternal health %D 2023 %7 18.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Women with overweight and obesity are at higher risk of developing complications in pregnancy such as gestational diabetes and longer-term chronic conditions. Research concerning health behavior change interventions during pregnancy and postpartum shows promising effects, but implementation into routine services is sparsely investigated. Most interventions focus on the antenatal or postpartum life stages, failing to meet the needs of women. IMPACT DIABETES Bump2Baby is a multicenter project across 4 high-income countries developed to test the implementation of an antenatal and postpartum evidence-based mobile health (mHealth) coaching intervention called Bump2Baby and Me (B2B&Me) designed to sit alongside usual care in the perinatal period. Objective: We aim to explore the feasibility and implementation of the B2B&Me intervention and investigate the effectiveness of this intervention in women at risk of gestational diabetes. Methods: IMPACT DIABETES Bump2Baby is a hybrid type 2 effectiveness-implementation study, which integrates an evidence-based mHealth coaching app that includes personalized health behavior change coaching provided by health care professionals alongside antenatal care from the first antenatal visit to 12 months postpartum. The mHealth app offers the possibility of synchronous calls, asynchronous contact (including coach-participant text and video messaging exchanges tailored to the participant’s needs), and ongoing access to an extensive library of bespoke intervention materials. Participants will interact asynchronously with their health coach throughout the intervention via the app. This randomized controlled trial across 4 clinical sites within Ireland, the United Kingdom, Spain, and Australia will recruit 800 women in early pregnancy to evaluate the effectiveness on postpartum weight. The Exploration, Preparation, Implementation, and Sustainment implementation framework is the theoretical underpinning of the study. The implementation evaluation will be assessed at the individual, hospital staff, and broader community levels using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Data sources for the RE-AIM evaluation will include app and platform analytics, screening and training records, participant medical records, key informant interviews, participant and partner exit interviews, cost data, study questionnaires, staff surveys, and blood sample analyses. Results: The study was approved and registered with the Australian New Zealand Clinical Trials Registry on November 19, 2020. Recruitment commenced on February 9, 2021, and data collection is ongoing. Publication of the results is expected in 2024. Conclusions: This is the first hybrid effectiveness-implementation study of an 18-month mHealth coaching intervention in at-risk women that we are aware of. As research aims to move toward real-world implementable solutions, it is critical that hybrid studies are conducted. The data from this large multicenter study will be useful in planning the potential implementation and scale-up of evidence-based perinatal health behavior change interventions. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620001240932; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380020&isReview=true International Registered Report Identifier (IRRID): DERR1-10.2196/51431 %M 37721798 %R 10.2196/51431 %U https://www.researchprotocols.org/2023/1/e51431 %U https://doi.org/10.2196/51431 %U http://www.ncbi.nlm.nih.gov/pubmed/37721798 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48208 %T Effectiveness of Social Virtual Reality Training in Enhancing Social Interaction Skills in Children With Attention-Deficit/Hyperactivity Disorder: Protocol for a Three-Arm Pilot Randomized Controlled Trial %A Wong,Ka Po %A Qin,Jing %+ Department of Applied Social Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China (Hong Kong), 852 64860214, wongkapoportia@gmail.com %K attention-deficit/hyperactivity disorder %K social interaction skills %K executive functioning %K emotional control %K 3-arm randomized controlled trial %K ADHD %K attention deficit %K hyperactive %K hyperactivity %K randomized %K RCT %K social interaction %K social interactions %K social skills %K child %K children %K youth %K pediatric %K pediatrics %K VR %K virtual reality %K childhood %K neurodevelopmental %D 2023 %7 18.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders among children. Children with ADHD have challenges in understanding social cues and behavioral problems when entering a social setting. Virtual reality (VR) has been applied to improve cognitive behaviors in children with ADHD. Previous studies have not adopted VR to improve social interaction competence and appropriateness in children with ADHD. VR offers a more effective alternative to therapeutic strategies for children with ADHD. Objective: This study aims to examine the feasibility and effectiveness of social VR training in enhancing social interaction skills compared to traditional social skills training in children with ADHD. We hypothesize that participants in the social VR training group are likely to perform better on social interaction skills than those in the traditional social skills training group. Methods: In this nonblinded, 3-arm randomized controlled trial (RCT), 90 participants with ADHD recruited from the community will be randomized 1:1:1 to the social VR intervention group, traditional social skills training group, or waitlist control group. The child psychiatrist will conduct assessments for each participant at baseline and after the intervention. The Social Skills Rating Scale–Parent will be used to assess the social interaction skills of the participants before and after the intervention. Participants in the social VR intervention group and traditional social skills training group will receive twelve 20-minute training sessions for 3 weeks. The participants in the waitlist control group will receive no training. The primary outcome measure is training acceptability and compliance. The secondary outcome measures are the child psychiatrist's assessment and the Social Skills Rating Scale–Parent before and after the intervention. Another outcome measure is the Behavior Rating Inventory of Executive Function and Attention. Differences in the scale scores will be examined using a t test and an F test. Results: This study is set to commence in the fourth quarter of 2023. It is anticipated that participants in the social VR intervention group will exhibit superior social interaction skills than those in the traditional social skills training group. Conclusions: To our knowledge, this RCT is the first study examining the feasibility and effectiveness of a social VR-based intervention for enhancing the social interaction skills of children with ADHD in Hong Kong. The VR-based social skills training is expected to provide a safer and more effective environment for children with ADHD to learn than the traditional approach. This study can lead to a full-scale RCT. Trial Registration: ClinicalTrials.gov NCT05778526; https://clinicaltrials.gov/study/NCT05778526 International Registered Report Identifier (IRRID): PRR1-10.2196/48208 %M 37721790 %R 10.2196/48208 %U https://www.researchprotocols.org/2023/1/e48208 %U https://doi.org/10.2196/48208 %U http://www.ncbi.nlm.nih.gov/pubmed/37721790 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47460 %T Obstructive Sleep Apnea and a Comprehensive Remotely Supervised Rehabilitation Program: Protocol for a Randomized Controlled Trial %A Hnatiak,Jakub %A Zikmund Galkova,Lujza %A Winnige,Petr %A Batalik,Ladislav %A Dosbaba,Filip %A Ludka,Ondrej %A Krejci,Jan %+ Department of Rehabilitation, University Hospital Brno, Jihlavska 20, Brno, 62500, Czech Republic, 420 532 23 3442, dosbaba.filip@fnbrno.cz %K obstructive sleep apnea %K telerehabilitation %K telemonitoring %K CPAP %K apnea-hypopnea index %K telehealth %K telemedicine %K sleep %K respiratory %K home based %K rehabilitation %K RCT %K randomized controlled trial %D 2023 %7 18.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Obstructive sleep apnea (OSA) is characterized by recurrent, intermittent partial or complete obstruction of the upper respiratory tract during sleep, which negatively affects the patient's daily quality of life (QoL). Middle-aged and older men who smoke and have obesity are most at risk. Even though the use of continuous positive airway pressure (CPAP) during sleep remains the gold standard treatment, various rehabilitation methods, such as exercise, respiratory therapy, myofunctional therapy, and nutritional lifestyle interventions, also appear to be effective. Moreover, it is increasingly recommended to use alternative or additional therapy options in combination with CPAP therapy. Objective: This study aims to evaluate if a comprehensive home-based, remotely supervised rehabilitation program (tele-RHB), in combination with standard therapy, can improve OSA severity by decreasing the apnea-hypopnea index (AHI); improve objective parameters of polysomnographic, spirometric, anthropometric, and body composition examinations; improve lipid profile, maximal mouth pressure, and functional capacity tests; and enhance the subjective perception of QoL, as well as daytime sleepiness in male participants with moderate to severe OSA. Our hypothesis is that a combination of the tele-RHB program and CPAP therapy will be more effective by improving OSA severity and the abovementioned parameters. Methods: This randomized controlled trial aims to recruit 50 male participants between the ages of 30 and 60 years with newly diagnosed moderate to severe OSA. Participants will be randomized 1:1, either to a 12-week tele-RHB program along with CPAP therapy or to CPAP therapy alone. After the completion of the intervention, the participants will be invited to complete a 1-year follow-up. The primary outcomes will be the polysomnographic value of AHI, Epworth Sleepiness Scale score, 36-Item Short Form Health Survey (SF-36) score, percentage of body fat, 6-minute walk test distance covered, as well as maximal inspiratory and expiratory mouth pressure values. Secondary outcomes will include polysomnographic values of oxygen desaturation index, supine AHI, total sleep time, average heart rate, mean oxygen saturation, and the percentage of time with oxygen saturation below 90%; anthropometric measurements of neck, waist, and hip circumference; BMI values; forced vital capacity; forced expiratory volume in 1 second; World Health Organization’s tool to measure QoL (WHOQOL-BREF) score; and lipid profile values. Results: Study recruitment began on October 25, 2021, and the estimated study completion date is December 2024. Analyses will be performed to examine whether the combination of the tele-RHB program and CPAP therapy will be more effective in the reduction of OSA severity and improvement of QoL, body composition and circumferences, exercise tolerance, lipid profile, as well as respiratory muscle and lung function, compared to CPAP therapy alone. Conclusions: The study will evaluate the effect of a comprehensive tele-RHB program on selected parameters mentioned above in male participants. The results of this intervention could help the further development of novel additional therapeutic home-based options for OSA. Trial Registration: ClinicalTrials.gov NCT04759456; https://clinicaltrials.gov/ct2/show/NCT04759456 International Registered Report Identifier (IRRID): DERR1-10.2196/47460 %M 37721786 %R 10.2196/47460 %U https://www.researchprotocols.org/2023/1/e47460 %U https://doi.org/10.2196/47460 %U http://www.ncbi.nlm.nih.gov/pubmed/37721786 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42409 %T Electronic Health Record–Driven Approaches in Primary Care to Strengthen Hypertension Management Among Racial and Ethnic Minoritized Groups in the United States: Systematic Review %A Ose,Dominik %A Adediran,Emmanuel %A Owens,Robert %A Gardner,Elena %A Mervis,Matthew %A Turner,Cindy %A Carlson,Emily %A Forbes,Danielle %A Jasumback,Caitlyn Lydia %A Stuligross,John %A Pohl,Susan %A Kiraly,Bernadette %+ Department of Family and Preventive Medicine, University of Utah, 375 Chipeta Way A, Salt Lake City, UT, 84108, United States, 1 801 581 7234, dominik.ose@hsc.utah.edu %K hypertension %K electronic health record (EHR) %K health data %K EHR-driven %K primary care %K racial and ethnic minority groups %D 2023 %7 15.9.2023 %9 Review %J J Med Internet Res %G English %X Background: Managing hypertension in racial and ethnic minoritized groups (eg, African American/Black patients) in primary care is highly relevant. However, evidence on whether or how electronic health record (EHR)–driven approaches in primary care can help improve hypertension management for patients of racial and ethnic minoritized groups in the United States remains scarce. Objective: This review aims to examine the role of the EHR in supporting interventions in primary care to strengthen the hypertension management of racial and ethnic minoritized groups in the United States. Methods: A search strategy based on the PICO (Population, Intervention, Comparison, and Outcome) guidelines was utilized to query and identify peer-reviewed articles on the Web of Science and PubMed databases. The search strategy was based on terms related to racial and ethnic minoritized groups, hypertension, primary care, and EHR-driven interventions. Articles were excluded if the focus was not hypertension management in racial and ethnic minoritized groups or if there was no mention of health record data utilization. Results: A total of 29 articles were included in this review. Regarding populations, Black/African American patients represented the largest population (26/29, 90%) followed by Hispanic/Latino (18/29, 62%), Asian American (7/29, 24%), and American Indian/Alaskan Native (2/29, 7%) patients. No study included patients who identified as Native Hawaiian/Pacific Islander. The EHR was used to identify patients (25/29, 86%), drive the intervention (21/29, 72%), and monitor results and outcomes (7/29, 59%). Most often, EHR-driven approaches were used for health coaching interventions, disease management programs, clinical decision support (CDS) systems, and best practice alerts (BPAs). Regarding outcomes, out of 8 EHR-driven health coaching interventions, only 3 (38%) reported significant results. In contrast, all the included studies related to CDS and BPA applications reported some significant results with respect to improving hypertension management. Conclusions: This review identified several use cases for the integration of the EHR in supporting primary care interventions to strengthen hypertension management in racial and ethnic minoritized patients in the United States. Some clinical-based interventions implementing CDS and BPA applications showed promising results. However, more research is needed on community-based interventions, particularly those focusing on patients who are Asian American, American Indian/Alaskan Native, and Native Hawaiian/Pacific Islander. The developed taxonomy comprising “identifying patients,” “driving intervention,” and “monitoring results” to classify EHR-driven approaches can be a helpful tool to facilitate this. %M 37713256 %R 10.2196/42409 %U https://www.jmir.org/2023/1/e42409 %U https://doi.org/10.2196/42409 %U http://www.ncbi.nlm.nih.gov/pubmed/37713256 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e33810 %T A Culturally Adapted Diet and Physical Activity Text Message Intervention to Prevent Type 2 Diabetes Mellitus for Women of Pakistani Origin Living in Scotland: Formative Study %A Krasuska,Marta %A Davidson,Emma M %A Beune,Erik %A Jenum,Anne Karen %A Gill,Jason MR %A Stronks,Karien %A van Valkengoed,Irene GM %A Diaz,Esperanza %A Sheikh,Aziz %+ Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, United Kingdom, 44 131 650 8102, emma.davidson@ed.ac.uk %K diabetes %K diet %K ethnic minority populations %K Pakistani %K physical activity %K prevention %K South Asian %K text messages %K women %K women’s health %K health intervention %K digital health %K mobile health %K minority %K exercise %K text message %K text messaging %K SMS %K development %K formative %K diabetes mellitus %D 2023 %7 15.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Individuals of South Asian origin are at an increased risk of developing type 2 diabetes mellitus (T2DM) compared with other ethnic minority groups. Therefore, there is a need to develop interventions to address, and reduce, this heightened risk. Objective: We undertook formative work to develop a culturally adapted diet and physical activity text message intervention to prevent T2DM for women of Pakistani origin living in Scotland. Methods: We used a stepwise approach that was informed by the Six Steps in Quality Intervention Development framework, which consisted of gathering evidence through literature review and focus groups (step 1), developing a program theory for the intervention (step 2), and finally developing the content of the text messages and an accompanying delivery plan (step 3). Results: In step 1, we reviewed 12 articles and identified 3 key themes describing factors impacting on diet and physical activity in the context of T2DM prevention: knowledge on ways to prevent T2DM through diet and physical activity; cultural, social, and gender norms; and perceived level of control and sense of inevitability over developing T2DM. The key themes that emerged from the 3 focus groups with a total of 25 women were the need for interventions to provide “friendly encouragement,” “companionship,” and a “focus on the individual” and also for the text messages to “set achievable goals” and include “information on cooking healthy meals.” We combined the findings of the focus groups and literature review to create 13 guiding principles for culturally adapting the text messages. In step 2, we developed a program theory, which specified the main determinants of change that our text messages should aim to enhance: knowledge and skills, sense of control, goal setting and planning behavior, peer support, and norms and beliefs guiding behavior. In step 3, we used both the intervention program theory and guiding principles to develop a set of 73 text messages aimed at supporting a healthy diet and 65 text messages supporting increasing physical activity. Conclusions: We present a theory-based approach to develop a culturally adapted diet and physical activity text message intervention to prevent T2DM for women of Pakistani origin living in Scotland. This study outlines an approach that may also be applicable to the development of interventions for other ethnic minority populations in diverse settings. There is now a need to build on this formative work and undertake a feasibility trial of a text message–based diet and physical activity intervention to prevent T2DM for women of Pakistani origin living in Scotland. %M 37713245 %R 10.2196/33810 %U https://formative.jmir.org/2023/1/e33810 %U https://doi.org/10.2196/33810 %U http://www.ncbi.nlm.nih.gov/pubmed/37713245 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e42712 %T Digital Health App to Address Disparate HIV Outcomes Among Black Women Living in Metro-Atlanta: Protocol for a Multiphase, Mixed Methods Pilot Feasibility Study %A Chandler,Rasheeta %A Farinu,Oluyemi T O %A Guillaume,Dominique %A Francis,Sherilyn %A Parker,Andrea G %A Shah,Kewal %A Hernandez,Natalie D %A , %+ Nell Hodgson Woodruff School of Nursing, Emory University, 1520 Clifton Rd NE, Atlanta, GA, 30322, United States, 1 404 727 8164, r.d.chandler@emory.edu %K Black women %K CBPR %K community-based participatory research %K HIV %K human centered design %K mhealth %K pilot usability study %D 2023 %7 15.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cisgender Black women in the southern United States are at heightened risk for HIV and adverse sexual and reproductive health outcomes. Mobile health interventions that target HIV risk while being adapted to the needs and lived experiences of Black women are remarkably limited. Objective: The study aims to refine SavvyHER, a mobile app for HIV prevention, with Black women residing in high HIV incidence areas of Georgia and evaluate the feasibility, acceptability, and usability of SavvyHER. This paper describes the procedures implemented to conduct this research. Methods: Community-based participatory research tenets guide this multiphase study to finalize the development of what we hypothesize will be an effective, sustainable, and culturally relevant HIV prevention and optimal sexual health and reproductive wellness app for Black women. This multiphased, mixed methods study consists of 3 phases. The first phase entails focus groups with Black women to understand their preferences for the functionality and design of a beta prototype version of SavvyHER. In the second phase, an app usability pretest (N=10) will be used to refine and optimize the SavvyHER app. The final phase will entail a pilot randomized controlled trial (N=60) to evaluate the app’s feasibility and usability in preparation for a larger trial. Results: Findings from preliminary focus groups revealed educational content, app aesthetics, privacy considerations, and marketing preferred by Black women, thus informing the first functional SavvyHER prototype. As we adapt and test the feasibility of SavvyHER, we hypothesize that the app will be an effective, sustainable, and culturally relevant HIV prevention, sexual health, and reproductive wellness tool for Black women. Conclusions: The findings from this research substantiate the importance of developing health interventions curated for and by Black women to address critical HIV disparities. The knowledge gained from this research can reduce HIV disparities among Black women through a targeted intervention that centers on their health needs and priorities. International Registered Report Identifier (IRRID): DERR1-10.2196/42712 %M 37713259 %R 10.2196/42712 %U https://www.researchprotocols.org/2023/1/e42712 %U https://doi.org/10.2196/42712 %U http://www.ncbi.nlm.nih.gov/pubmed/37713259 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47666 %T Understanding Physical Activity Determinants in an HIV Self-Management Intervention: Qualitative Analysis Guided by the Theory of Planned Behavior %A Sanabria,Gabriella %A Bushover,Brady %A Ashrafnia,Sarah %A Cordoba,Evette %A Schnall,Rebecca %+ Division of Scholarship and Research, Columbia University School of Nursing, 560 West 168th Street, New York, NY, 10032, United States, 1 2123426886, rb897@columbia.edu %K HIV/AIDS %K mobile Health %K mHealth %K fitness tracker %K physical activity %K self-management %K HIV %K AIDS %K activity %K mortality %K app %K fitness %K qualitative %K tracking %K behavior %K mobile phone %D 2023 %7 14.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: People living with HIV have long life expectancy and are experiencing more comorbid conditions, being at an increased risk for developing cardiovascular disease (CVD) and diabetes, further exacerbated due to the HIV or inflammatory process. One effective intervention shown to decrease mortality and improve health outcomes related to CVD and diabetes in people living with HIV is increased regular physical activity. However, people living with HIV often fall short of the daily recommended physical activity levels. While studies show that mobile health (mHealth) can potentially help improve people’s daily activity levels and reduce mortality rates due to comorbid conditions, these studies do not specifically focus on people living with HIV. As such, it is essential to understand how mHealth interventions, such as wearables, can improve the physical activity of people living with HIV. Objective: This study aimed to understand participants’ experiences wearing a fitness tracker and an app to improve their physical activity. Methods: In total, 6 focus groups were conducted with participants who completed the control arm of a 6-month randomized controlled trial (ClinicalTrials.gov NCT03205982). The control arm received daily walk step reminders to walk at least 5000 steps per day and focused on the overall wellness of the individual. The analysis of the qualitative focus groups used inductive content analysis using the theory of planned behavior as a framework to guide and organize the analysis. Results: In total, 41 people living with HIV participated in the focus groups. The majority (n=26, 63%) of participants reported their race as Black or African American, and 32% (n=13) of them identified their ethnicity as Hispanic or Latino. In total, 9 major themes were identified and organized following the theory of planned behavior constructs. Overall, 2 major themes (positive attitude toward tracking steps and tracking steps is motivating) related to attitudes toward the behavior, 2 major themes (social support or motivation from the fitness tracker and app and encouragement from family and friends) related to participant’s subjective norms, 1 theme (you can adjust your daily habits with time) related to perceived behavioral control, 2 themes (reach their step goal and have a healthier lifestyle) related to participant’s intention, and 2 themes (continuing to walk actively and regularly wearing the fitness tracker) related to participant’s changed behavior. Participants highlighted how the mHealth interface with the avatar and daily step tracking motivated them to both begin and continue to engage in physical activity by adjusting their daily routines. Conclusions: Findings from this study illustrate how features of mHealth apps may motivate people living with HIV to start and continue sustained engagement in physical activities. This sustained increase in physical activity is crucial for reducing the risk of comorbid conditions such as diabetes or CVD. Trial Registration: ClinicalTrials.gov NCT03205982; https://classic.clinicaltrials.gov/ct2/show/NCT03205982 %M 37707942 %R 10.2196/47666 %U https://formative.jmir.org/2023/1/e47666 %U https://doi.org/10.2196/47666 %U http://www.ncbi.nlm.nih.gov/pubmed/37707942 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43099 %T The Dosing of Mobile-Based Just-in-Time Adaptive Self-Management Prompts for Caregivers: Preliminary Findings From a Pilot Microrandomized Study %A Wang,Jitao %A Wu,Zhenke %A Choi,Sung Won %A Sen,Srijan %A Yan,Xinghui %A Miner,Jennifer A %A Sander,Angelle M %A Lyden,Angela K %A Troost,Jonathan P %A Carlozzi,Noelle E %+ Department of Physical Medicine and Rehabilitation, University of Michigan, 2800 Plymouth Road, Ann Arbor, MI, 48103, United States, 1 7347638917, carlozzi@med.umich.edu %K caregiver %K just-in-time adaptive intervention %K JITAI %K mobile health intervention %K health-related quality of life %K HRQOL %K intervention %K self-management %K quality of life %K psychological %K effectiveness %K acceptability %K feasibility %K design %K anxiety %K depression %K quality of life %K QOL %K affect %K medication %K pharma %K rehab %K wearable %K ubiquitous %K accelerometer %K sleep %K polysomnography %K PROMIS Anxiety %K PROMIS Depression %K computer adaptive test %K CAT %K generalized estimating equations %K GEE %K weighted and centered least square %K WCLS %D 2023 %7 14.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Caregivers of people with chronic illnesses often face negative stress-related health outcomes and are unavailable for traditional face-to-face interventions due to the intensity and constraints of their caregiver role. Just-in-time adaptive interventions (JITAIs) have emerged as a design framework that is particularly suited for interventional mobile health studies that deliver in-the-moment prompts that aim to promote healthy behavioral and psychological changes while minimizing user burden and expense. While JITAIs have the potential to improve caregivers’ health-related quality of life (HRQOL), their effectiveness for caregivers remains poorly understood. Objective: The primary objective of this study is to evaluate the dose-response relationship of a fully automated JITAI-based self-management intervention involving personalized mobile app notifications targeted at decreasing the level of caregiver strain, anxiety, and depression. The secondary objective is to investigate whether the effectiveness of this mobile health intervention was moderated by the caregiver group. We also explored whether the effectiveness of this intervention was moderated by (1) previous HRQOL measures, (2) the number of weeks in the study, (3) step count, and (4) minutes of sleep. Methods: We examined 36 caregivers from 3 disease groups (10 from spinal cord injury, 11 from Huntington disease, and 25 from allogeneic hematopoietic cell transplantation) in the intervention arm of a larger randomized controlled trial (subjects in the other arm received no prompts from the mobile app) designed to examine the acceptability and feasibility of this intensive type of trial design. A series of multivariate linear models implementing a weighted and centered least squares estimator were used to assess the JITAI efficacy and effect. Results: We found preliminary support for a positive dose-response relationship between the number of administered JITAI messages and JITAI efficacy in improving caregiver strain, anxiety, and depression; while most of these associations did not meet conventional levels of significance, there was a significant association between high-frequency JITAI and caregiver strain. Specifically, administering 5-6 messages per week as opposed to no messages resulted in a significant decrease in the HRQOL score of caregiver strain with an estimate of –6.31 (95% CI –11.76 to –0.12; P=.046). In addition, we found that the caregiver groups and the participants’ levels of depression in the previous week moderated JITAI efficacy. Conclusions: This study provides preliminary evidence to support the effectiveness of the self-management JITAI and offers practical guidance for designing future personalized JITAI strategies for diverse caregiver groups. Trial Registration: ClinicalTrials.gov NCT04556591; https://clinicaltrials.gov/ct2/show/NCT04556591 %M 37707948 %R 10.2196/43099 %U https://formative.jmir.org/2023/1/e43099 %U https://doi.org/10.2196/43099 %U http://www.ncbi.nlm.nih.gov/pubmed/37707948 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48437 %T Internet-Based Cognitive Behavioral Therapy and Virtual Reality Exposure Therapy for Social Anxiety Disorder: Protocol for a Randomized Controlled Trial in Hong Kong %A Pan,Jia-Yan %+ Department of Social Work, Hong Kong Baptist University, 10/F, Academic and Administration Building, 15 Baptist University Road, Baptist University Road Campus, Hong Kong, China (Hong Kong), 852 34116415, jiayan@hkbu.edu.hk %K internet-based cognitive behavioral therapy %K virtual reality exposure therapy %K social anxiety disorder %K Chinese %K CBT %K iCBT %K internet %K virtual reality %K anxiety %K social phobia %K mental disorder %K mental health %K quality of life %K treatment %K cognitive behavioral therapy %K psychological intervention %D 2023 %7 14.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Social anxiety disorder (SAD), also known as social phobia, is one of the most common mental disorders worldwide. In Hong Kong, the prevalence of SAD is high, but its treatment rate is low. SAD has immense impact on academic or work performance, social life, career development, and quality of life. One of the most effective treatments for SAD is cognitive behavioral therapy (CBT), with internet-based CBT (iCBT) and virtual reality exposure therapy (VRET) showing promise in treating SAD. However, internet interventions are underdeveloped in Chinese communities including Hong Kong. Objective: This study aims to develop an iCBT program that includes VRET, called “Ease Anxiety in Social Event Online” (Ease Online), for Hong Kong adults with SAD in a randomized controlled trial. Methods: The 14-week Ease Online program is a guided self-help iCBT program with a blended mode of service delivery. The program comprises 9 web-based modules and 5 individual counseling sessions (including 2 VRET sessions) conducted remotely or face-to-face with a therapist to provide therapist support, as guided iCBT shows superior effects than unguided iCBT. Other program components include therapist feedback on assignments, internal messages, forums, client portfolios, web-based questionnaires, reminders, and web-based bookings. The program can be accessed either through a mobile app or program website through a PC with an internet connection. The participants are openly recruited and screened using a questionnaire and through an intake interview. Eligible participants are randomized by placing them into a web-based iCBT group, app-based iCBT group, or a waitlist control (WLC) group. Participants in the WLC group are assigned to the app-based program upon completion of the service of the 2 experimental groups. Measurements of social anxiety, depression and anxiety symptoms, psychological distress, automatic thoughts, and quality of life are administered at pretest, posttest, and 3- and 6-month follow-ups. Multivariate ANOVA with repeated measures will be performed to determine the intervention effectiveness on the continuous variables over time. Results: Participant recruitment commenced in January 2021. As of February 2023, a total of 1811 individuals applied for the Ease Online program. In total, 401 intake interviews have been completed, and 329 eligible participants have joined the program, among whom 166 have completed the service. Data collection is still ongoing, which is expected to be completed in March 2024. Conclusions: This study is the first of its kind in combining iCBT and VRET for the treatment of SAD in Hong Kong. At a theoretical level, this study contributes to the development and evaluation of internet-based psychological interventions in Hong Kong. At a practical level, the Ease Online program may serve as an alternative service option for SAD clients in Hong Kong if proven effective. Trial Registration: ClinicalTrials.gov NCT04995913; https://clinicaltrials.gov/study/NCT04995913 International Registered Report Identifier (IRRID): DERR1-10.2196/48437 %M 37707944 %R 10.2196/48437 %U https://www.researchprotocols.org/2023/1/e48437 %U https://doi.org/10.2196/48437 %U http://www.ncbi.nlm.nih.gov/pubmed/37707944 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44016 %T Web-Based Self-Compassion Training to Improve the Well-Being of Youth With Chronic Medical Conditions: Randomized Controlled Trial %A Finlay-Jones,Amy Louise %A Parkinson,Asha %A Sirois,Fuschia %A Perry,Yael %A Boyes,Mark %A Rees,Clare S %+ Youth Mental Health Team, Telethon Kids Institute, 15 Hospital Avenue, Nedlands, 6009, Australia, 61 08 63191808, Amy.Finlay-Jones@telethonkids.org.au %K self-compassion %K chronic illness %K adolescent psychology %K mental health %K digital interventions %K internet %K well-being %K mobile phone %D 2023 %7 13.9.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Up to one-third of young people live with chronic physical conditions (eg, diabetes, asthma, and autoimmune disease) that frequently involve recurrent pain, fatigue, activity limitations, stigma, and isolation. These issues may be exacerbated as young people transition through adolescence. Accordingly, young people with chronic illness are at a high risk of psychological distress. Accessible, evidence-based interventions for young people with chronic illnesses are urgently needed to improve well-being, support adaptation, and enhance daily functioning. Self-compassion, which is an adaptive means of relating to oneself during times of difficulty, is a promising intervention target for this population. Objective: This study aims to test the efficacy of a 4-week, self-guided, web-based self-compassion training program for improving well-being among young Australians (aged 16-25 years) living with a chronic medical condition. The primary outcomes were self-compassion, emotion regulation difficulties, and coping; the secondary outcomes were well-being, distress, and quality of life. We also sought to test whether changes in primary outcomes mediated changes in secondary outcomes and gather feedback about the strengths and limitations of the program. Methods: We conducted a single-blind, parallel-group, randomized controlled trial comparing a 4-week, fully automated, web-based self-compassion training program with a waitlist control. Participants were recruited via the internet, and outcomes were self-assessed at 4 (T1) and 12 weeks (T2) after the baseline time point via a web-based survey. A mixed methods approach was used to evaluate the program feedback. Results: Overall, 151 patients (age: mean 21.15, SD 2.77 years; female patients: n=132, 87.4%) were randomized to the intervention (n=76, 50.3%) and control (n=75, 49.7%) groups. The loss–to–follow-up rate was 47.4%, and program use statistics indicated that only 29% (22/76) of young people in the experimental group completed 100% of the program. The main reported barrier to completion was a lack of time. As anticipated, treatment effects were observed for self-compassion (P=.01; partial η2=0.05; small effect); well-being (P≤.001; partial η2=0.07; medium effect); and distress (P=.003; partial η2=0.054; small-medium effect) at the posttest time point and maintained at follow-up. Contrary to our hypotheses, no intervention effects were observed for emotion regulation difficulties or maladaptive coping strategies. Improvements in adaptive coping were observed at the posttest time point but were not maintained at follow-up. Self-compassion, but not emotion regulation difficulties or coping, mediated the improvements in well-being. Conclusions: Minimal-contact, web-based self-compassion training can confer mental health benefits on young people with chronic conditions. This group experiences substantial challenges to participation in mental health supports, and program engagement and retention in this trial were suboptimal. Future work should focus on refining the program content, engagement, and delivery to optimize engagement and treatment outcomes for the target group. Trial Registration: Australian New Zealand Clinical Trials Registry 12619000572167; https://tinyurl.com/5n6hevt International Registered Report Identifier (IRRID): RR2-10.1186/s12889-020-8226-7 %M 37703081 %R 10.2196/44016 %U https://www.jmir.org/2023/1/e44016 %U https://doi.org/10.2196/44016 %U http://www.ncbi.nlm.nih.gov/pubmed/37703081 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e36808 %T Expectations of Tele-Yoga in Persons With Long-Term Illness: Qualitative Content Analysis %A Hedbom,Towe %A Liljeroos,Maria %A Thylén,Ingela %A Orwelius,Lotti %A Jaarsma,Tiny %A Strömberg,Anna %+ Department of Health, Medicine and Caring Sciences, Linkoping University, Campus US, Linkoping, 58183, Sweden, 46 700850901, towe.hedbom@liu.se %K yoga %K telerehabilitation %K eHealth %K chronic illness %K heart failure %K implantable cardioverter defibrillator %K postintensive care %D 2023 %7 13.9.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Yoga is a mind-body exercise that has demonstrated its feasibility and safety even for individuals with severe long-term illness. Engaging in yoga has the potential to yield positive effects on both physical and mental well-being. Tele-yoga is a novel approach to rehabilitation in which participants practice group yoga with a live-streamed yoga instructor digitally via a tablet. This is especially beneficial for individuals who may find it difficult to leave their homes to participate in an exercise session. As part of our ongoing evaluation of the tele-yoga intervention in individuals with long-term illness, we have undertaken an exploration of participants’ expectations regarding yoga in general and tele-yoga specifically. Understanding these expectations is crucial, as they can significantly impact their satisfaction with treatment and care and influence overall intervention outcomes. Objective: This study aims to explore the expectations of tele-yoga among individuals with long-term illness before starting a tele-yoga intervention. Methods: The study employed an inductive qualitative design and is part of a process evaluation within an ongoing randomized controlled trial. A total of 89 participants were interviewed before the start of the tele-yoga intervention. The interview guide encompassed questions about their general perceptions of yoga and the specific expectations they held for the upcoming tele-yoga sessions. The interviews were transcribed and analyzed using inductive qualitative content analysis. Results: Participants expressed their expectations for tele-yoga, focusing on the anticipated improvements in physical function and overall health. These expectations included hopes for reduced respiratory issues; relief from discomfort, aches, and pains; as well as increased physical flexibility, coordination, and overall well-being. Besides, they expected to achieve improved psychological well-being and performance; to acquire strategies to manage stress, anger, and anxiety; and to have their motivational drive strengthened and influence other activities. Participants described tele-yoga as a new and exciting technical solution that would facilitate the delivery of yoga. A few participants remained a little hesitant toward the use of technology, with some expectations based on previous experiences. When asked about expectations, some had no idea about what to expect. Participants also had varying perspectives on yoga, with some finding it mysterious and difficult to understand. Participants expressed thoughts that they found the idea of tele-yoga taking place in groups exciting and enjoyable. They also had expectations that being part of a group would provide opportunities for mutual inspiration and encouragement among the group members. Conclusions: Expectations before an intervention can provide valuable insights into understanding the factors influencing adherence to tele-yoga and its outcomes. Our findings provide a wide range of expectations for tele-yoga, spanning both physical and mental aspects. Moreover, the technology’s potential to facilitate yoga delivery and the supportive nature of digital group interactions were evident from the results. Trial Registration: ClinicalTrials.gov NCT03703609; https://clinicaltrials.gov/ct2/show/NCT03703609 %M 37703082 %R 10.2196/36808 %U https://www.jmir.org/2023/1/e36808 %U https://doi.org/10.2196/36808 %U http://www.ncbi.nlm.nih.gov/pubmed/37703082 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e49115 %T Impact on Knowledge, Competence, and Performance of a Faculty-Led Web-Based Educational Activity for Type 2 Diabetes and Obesity: Questionnaire Study Among Health Care Professionals and Analysis of Anonymized Patient Records %A Okemah,Jennifer %A Neunie,Sola %A Noble,Alexander %A Wysham,Carol %+ Rockwood Center for Diabetes and Endocrinology, 400 E 5th Ave #4, Spokane, WA, 99202, United States, 1 509 838 2531, Carol.Wysham@multicare.org %K continuing medical education %K incretin-based therapy %K multidisciplinary care %K obesity %K overweight %K type 2 diabetes %K patient data %K diabetes management %K patient education %K chronic disease %K web-based education %K digital education %K health education %K diabetes %K diabetes mellitus %K survey %K web-based survey %K education %K glycemic %D 2023 %7 13.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Strategies for managing type 2 diabetes (T2D) and obesity are evolving with the introduction of targeted therapies, including incretin-based dual agonists and growing knowledge of the importance of multidisciplinary care. Accessible, effective continuing medical education (CME) activities are required to ensure that health care professionals (HCPs) understand and can implement the most recent data to optimize patient outcomes. Objective: We aimed to measure changes in knowledge, competence, and self-reported performance and quantitatively evaluate changes in performance using anonymized patient data following participation in a web-based educational activity. The faculty-led CME-accredited activity was based on incretin-based dual agonists and patient education on T2D and obesity. The remaining educational gaps in this field were also identified. Methods: A CME-accredited, web-based, multidisciplinary (touchMDT) educational activity titled “The future for glycemic control and weight loss in T2D and obesity: Incretin-based dual-agonists and optimizing patient education” was developed. HCP knowledge, competence, and performance were assessed before and after the activity against Moore’s expanded outcomes framework (levels 1-5), using self-reported questionnaires and by analyzing anonymized patient record data. Results: For evaluating knowledge and competence (50 respondents before and 50 learners after the activity), the mean number of correctly answered questions was significantly higher post activity (median 5.0, IQR 4.0-6.0 to 6.0, IQR 5.0-7.0; mean 4.98, SD 1.22 to 5.78, SD 1.13; P<.001). Modest, nonsignificant improvements in self-reported performance (N=50 respondents preactivity; N=50 learners postactivity) from before to after the activity were observed (median 4.0, IQR 3.25-4.0 to 4.0, IQR 4.0-4.0; mean 3.64, SD 0.69 to 3.76, SD 0.48; P=.32). PPatient data analysis indicated that patients were being treated more intensively postactivity: before the activity, the most commonly used treatment regimens were metformin monotherapy (13/50, 26%) and dual therapy with metformin plus injectable glucagon-like peptide-1 (GLP-1) receptor agonist (RA; 11/50, 22%); post activity, this changed to dual therapy with metformin plus injectable GLP-1 RA (12/50, 24%) and triple therapy with metformin plus injectable GLP-1 RA plus sodium-glucose cotransporter-2 inhibitor (SGLT2i; 10/50, 20%). In addition, there was an increased number of referrals to a combination of specialists (physicians referred 27%, 8/30 of patients to ≥2 specialists before the activity and 36%, 10/28 to ≥2 specialists post activity). The remaining educational gaps included understanding the biology and psychology of obesity, efficacy and safety data for incretin-based dual agonists, and the role of the diabetes educator or diabetes care and education specialist in managing T2D and obesity. Conclusions: This short, web-based CME activity on the management of T2D and obesity led to improvements in HCP knowledge, competence, and performance. Several remaining unmet needs were identified, which can be used to inform the content of future educational activities in this disease area. %M 37703084 %R 10.2196/49115 %U https://formative.jmir.org/2023/1/e49115 %U https://doi.org/10.2196/49115 %U http://www.ncbi.nlm.nih.gov/pubmed/37703084 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46115 %T Understanding Whether and How a Digital Health Intervention Improves Transition Care for Emerging Adults Living With Type 1 Diabetes: Protocol for a Mixed Methods Realist Evaluation %A Wang,Ruoxi %A Rouleau,Geneviève %A Booth,Gillian Lynn %A Brazeau,Anne-Sophie %A El-Dassouki,Noor %A Taylor,Madison %A Cafazzo,Joseph A %A Greenberg,Marley %A Nakhla,Meranda %A Shulman,Rayzel %A Desveaux,Laura %+ Institute for Better Health, Trillium Health Partners, 100 Queensway W, Mississauga, ON, L5B 1B8, Canada, 1 437 772 6836, laura.desveaux@thp.ca %K digital health %K emerging adults %K realist evaluation %K self-management %K transition to adult care %K type 1 diabetes %D 2023 %7 13.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Emerging adults living with type 1 diabetes (T1D) face a series of challenges with self-management and decreased health system engagement, leading to an increased risk of acute complications and hospital admissions. Effective and scalable strategies are needed to support this population to transfer seamlessly from pediatric to adult care with sufficient self-management capability. While digital health interventions for T1D self-management are a promising strategy, it remains unclear which elements work, how, and for which groups of individuals. Objective: This study aims to evaluate the design and implementation of a multicomponent SMS text message–based digital health intervention to support emerging adults living with T1D in real-world settings. The objectives are to identify the intervention components and associated mechanisms that support user engagement and T1D health care transition experiences and determine the individual characteristics that influence the implementation process. Methods: We used a realist evaluation embedded alongside a randomized controlled trial, which uses a sequential mixed methods design to analyze data from multiple sources, including intervention usage data, patient-reported outcomes, and realist interviews. In step 1, we conducted a document analysis to develop a program theory that outlines the hypothesized relationships among “individual-level contextual factors, intervention components and features, mechanisms, and outcomes,” with special attention paid to user engagement. Among them, intervention components and features depict 10 core characteristics such as transition support information, problem-solving information, and real-time interactivity. The proximal outcomes of interest include user engagement, self-efficacy, and negative emotions, whereas the distal outcomes of interest include transition readiness, self-blood glucose monitoring behaviors, and blood glucose. In step 2, we plan to conduct semistructured realist interviews with the randomized controlled trial’s intervention-arm participants to test the hypothesized “context-intervention-mechanism-outcome” configurations. In step 3, we plan to triangulate all sources of data using a coincidence analysis to identify the necessary combinations of factors that determine whether and how the desired outcomes are achieved and use these insights to consolidate the program theory. Results: For step 1 analysis, we have developed the initial program theory and the corresponding data collection plan. For step 2 analysis, participant enrollment for the randomized controlled trial started in January 2023. Participant enrollment for this realist evaluation was anticipated to start in July 2023 and continue until we reached thematic saturation or achieved informational power. Conclusions: Beyond contributing to knowledge on the multiple pathways that lead to successful engagement with a digital health intervention as well as target outcomes in T1D care transitions, embedding the realist evaluation alongside the trial may inform real-time intervention refinement to improve user engagement and transition experiences. The knowledge gained from this study may inform the design, implementation, and evaluation of future digital health interventions that aim to improve transition experiences. International Registered Report Identifier (IRRID): PRR1-10.2196/46115 %M 37703070 %R 10.2196/46115 %U https://www.researchprotocols.org/2023/1/e46115 %U https://doi.org/10.2196/46115 %U http://www.ncbi.nlm.nih.gov/pubmed/37703070 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e43654 %T A Tailored mHealth Intervention for Improving Antenatal Care Seeking and Health Behavioral Determinants During Pregnancy Among Adolescent Girls and Young Women in South Africa: Development and Protocol for a Pilot Randomized Controlled Trial %A Sewpaul,Ronel %A Resnicow,Ken %A Crutzen,Rik %A Dukhi,Natisha %A Ellahebokus,Afzal %A Reddy,Priscilla %+ Public Health, Societies and Belonging, Human Sciences Research Council, 134 Pretorius Street, Pretoria, 0002, South Africa, 27 214667912, rsewpaul@hsrc.ac.za %K antenatal care %K adolescent girls and young women %K AGYW %K adolescent pregnancy %K mobile health %K mHealth %K tailoring %K motivational interviewing %K South Africa %K mobile phone %D 2023 %7 13.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: South Africa, a middle-income country, has an adolescent fertility rate far higher than that of high-income countries. Adolescent girls and young women have an increased risk of pregnancy-related complications and lower antenatal appointment attendance rates than older adult pregnant women. Mobile health (mHealth) interventions to improve health behaviors among pregnant adolescent girls and young women in low- and middle-income countries are scarce. Objective: This paper describes the development and components of an mHealth intervention to improve antenatal appointment attendance and health behavioral determinants among pregnant adolescent girls and young women in South Africa and details the protocol for a pilot randomized controlled trial that evaluated the intervention’s efficacy and user acceptability. Methods: The intervention, Teen MomConnect, sent tailored motivational behavior change and behavioral reinforcement SMS text messages to participants about antenatal appointment keeping and pregnancy behaviors. The delivery methodology of the intervention was adapted from MomConnect, an mHealth education program for pregnant women in South Africa that has nationwide coverage. In addition, participants received a face-to-face motivational interviewing session delivered by a trained research assistant. Pregnant adolescent girls and young women aged 13 to 20 years were recruited from health facilities and community networks. Participants were randomized into the control group that received the standard MomConnect health SMS text messages or the experimental group that received the Teen MomConnect intervention. Participants completed a baseline questionnaire upon enrollment in the study and a follow-up questionnaire after the end of their pregnancy. The questionnaires assessed demographic characteristics, pregnancy behaviors, and the psychosocial determinants of antenatal appointment attendance (knowledge, attitudes, social support, risk perceptions, self-efficacy, intention, and action planning). Feasibility was assessed using descriptive analyses of acceptability, study implementation processes, and perceived satisfaction with the intervention. The number of appointments attended was obtained from the participants’ clinic records. Appointment attendance was compared between the control and experimental groups, as were awareness of HIV status and the psychosocial determinants of antenatal appointment attendance. Results: Participant recruitment was conducted from May 2018 to December 2018, and the questionnaire-based data collection was completed by December 2019. Overall, 412 participants were enrolled. Conclusions: This paper describes the Teen MomConnect intervention to improve antenatal appointment attendance and pregnancy health behaviors among adolescent girls and young women. The results on the intervention’s preliminary efficacy and user acceptability will inform policy makers and health program officers on how tailored, age-appropriate, and motivational health behavior messages can be delivered via mobile phone to pregnant adolescent girls and young women. Trial Registration: Pan African Clinical Trial Registry (PACTR) PACTR201912734889796; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9565 International Registered Report Identifier (IRRID): DERR1-10.2196/43654 %M 37703092 %R 10.2196/43654 %U https://www.researchprotocols.org/2023/1/e43654 %U https://doi.org/10.2196/43654 %U http://www.ncbi.nlm.nih.gov/pubmed/37703092 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e38481 %T Using the AllerSearch Smartphone App to Assess the Association Between Dry Eye and Hay Fever: mHealth-Based Cross-Sectional Study %A Inomata,Takenori %A Sung,Jaemyoung %A Nakamura,Masahiro %A Iwagami,Masao %A Akasaki,Yasutsugu %A Fujio,Kenta %A Nakamura,Masahiro %A Ebihara,Nobuyuki %A Ide,Takuma %A Nagao,Masashi %A Okumura,Yuichi %A Nagino,Ken %A Fujimoto,Keiichi %A Eguchi,Atsuko %A Hirosawa,Kunihiko %A Midorikawa-Inomata,Akie %A Muto,Kaori %A Fujisawa,Kumiko %A Kikuchi,Yota %A Nojiri,Shuko %A Murakami,Akira %+ Department of Ophthalmology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 1130033, Japan, 81 338133111, tinoma@juntendo.ac.jp %K dry eye %K hay fever %K mobile health %K personalized medicine %K smartphone %K pollinosis %K rhinitis %K allergic conjunctivitis %K nasal symptom score %K nonnasal symptom score %K Ocular Surface Disease Index %K Japanese Allergic Conjunctival Disease Standard Quality of Life Questionnaire %K mobile phone %D 2023 %7 12.9.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Dry eye (DE) and hay fever (HF) show synergistic exacerbation of each other’s pathology through inflammatory pathways. Objective: This study aimed to investigate the association between DE and HF comorbidity and the related risk factors. Methods: A cross-sectional observational study was conducted using crowdsourced multidimensional data from individuals who downloaded the AllerSearch smartphone app in Japan between February 2018 and May 2020. AllerSearch collected the demographics, medical history, lifestyle and residential information, HF status, DE symptoms, and HF-related quality of life. HF symptoms were evaluated using the nasal symptom score (0-15 points) and nonnasal symptom score (0-12 points). HF was defined by the participants’ responses to the questionnaire as HF, non-HF, or unknown. Symptomatic DE was defined as an Ocular Surface Disease Index total score (0-100 points), with a threshold score of 13 points. HF-related quality of life was assessed using the Japanese Allergic Conjunctival Disease Standard Quality of Life Questionnaire (0-68 points). We conducted a multivariable linear regression analysis to examine the association between the severity of DE and HF symptoms. We subsequently conducted a multivariable logistic regression analysis to identify the factors associated with symptomatic DE (vs nonsymptomatic DE) among individuals with HF. Dimension reduction via Uniform Manifold Approximation and Projection stratified the comorbid DE and HF symptoms. The symptom profiles in each cluster were identified using hierarchical heat maps. Results: This study included 11,284 participants, classified into experiencing HF (9041 participants), non-HF (720 participants), and unknown (1523 participants) groups. The prevalence of symptomatic DE among individuals with HF was 49.99% (4429/9041). Severe DE symptoms were significantly associated with severe HF symptoms: coefficient 1.33 (95% CI 1.10-1.57; P<.001) for mild DE, coefficient 2.16 (95% CI 1.84-2.48; P<.001) for moderate DE, and coefficient 3.80 (95% CI 3.50-4.11; P<.001) for severe DE. The risk factors for comorbid symptomatic DE among individuals with HF were identified as female sex; lower BMI; medicated hypertension; history of hematologic, collagen, heart, liver, respiratory, or atopic disease; tomato allergy; current and previous mental illness; pet ownership; living room and bedrooms furnished with materials other than hardwood, carpet, tatami, and vinyl; discontinuation of contact lens use during the HF season; current contact lens use; smoking habits; and sleep duration of <6 hours per day. Uniform Manifold Approximation and Projection stratified the heterogeneous comorbid DE and HF symptoms into 14 clusters. In the hierarchical heat map, cluster 9 was comorbid with the most severe HF and DE symptoms, and cluster 1 showed severe HF symptoms with minimal DE-related symptoms. Conclusions: This crowdsourced study suggested a significant association between severe DE and HF symptoms. Detecting DE among individuals with HF could allow effective prevention and interventions through concurrent treatment for ocular surface management along with HF treatment. %M 37698897 %R 10.2196/38481 %U https://www.jmir.org/2023/1/e38481 %U https://doi.org/10.2196/38481 %U http://www.ncbi.nlm.nih.gov/pubmed/37698897 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e45957 %T Development of an App for Tracking Family Engagement With Early Intervention Services: Focus Groups and Pilot Evaluation Study %A Wagner,Liliana %A Corona,Laura %A Khan,Nibraas %A Hooper,Madison %A Dixon,Alexa %A Munoz Lavanderos,Ambar %A Zheng,Zhaobo %A Sarkar,Nandan %A Sarkar,Nilanjan %A Warren,Zachary %+ Department of Pediatrics, Vanderbilt University Medical Center, 1241 Blakemore Avenue, # 161, Nashville, TN, 37212, United States, 1 615 936 5777, liliana.wagner@vumc.org %K mobile health %K early intervention %K families %K mobile phone %K autism %K focus groups %D 2023 %7 12.9.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Expedient access to early intervention (EI) systems has been identified as a priority for children with developmental delays, identified disabilities, and other special health care needs. Despite the mandated availability of EI, it remains challenging for families to navigate referral processes and establish appropriate services. Such challenges disproportionately affect families from traditionally underserved communities. Mobile health apps can improve clinical outcomes, increase accessibility to health services, and promote adherence to health-related interventions. Though promising, the implementation of apps within routine care is in its infancy, with limited research examining the components of what makes an effective app or how to reach families most impacted by inequities in health care delivery. Objective: In study 1, we conducted focus groups to access a broad range of perspectives on the process of navigating the EI system, with the dual goals of identifying ways in which a patient-facing app might facilitate this process and identifying barriers to use with traditionally underrepresented and underserved groups. In study 2, focus group findings informed the development of a patient-facing app, which was subsequently tested with a pilot sample of 5 families. Methods: In study 1, the focus groups included 29 participants from 4 shareholder groups. Targeted sampling was used to recruit participants from traditionally underrepresented groups. Focus group questions sought information about barriers families experience as they navigate the EI system, ideal features of a patient-facing app designed to track family engagement with the EI system, and potential barriers. Focus group procedures were informed by the Consolidated Framework for Implementation Research framework. In study 2, a pilot app was developed. The app was tested with a sample of 5 families of young children involved in the EI system. Families provided information on app functionality and usability. Results: Qualitative analysis revealed a desire for increased communication and information about the process of accessing EI services, potential utility of an app for communication purposes, and clear recommendations for app features. Insights from focus groups were used to inform the development of the Family on Track app and related implementation supports. App features included survey customization, timing and delivery of prompts, and questions related to barriers and service satisfaction. Implementation supports include a visual guide for app installation, resources related to common family questions, and availability of study personnel to guide families through installation and provide ongoing support. Field testing provided preliminary information about app usability, including identifying future directions. Conclusions: The results of this study could support the development of a new way for the EI system to communicate and connect with families, provide families with a means to communicate satisfaction and frustration, and access the supports they need to be active participants in their child’s care. %M 37698912 %R 10.2196/45957 %U https://humanfactors.jmir.org/2023/1/e45957 %U https://doi.org/10.2196/45957 %U http://www.ncbi.nlm.nih.gov/pubmed/37698912 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49999 %T A Family-Based Mental Health Navigator Intervention for Youth in the Child Welfare System: Protocol for a Randomized Controlled Trial %A Tolou-Shams,Marina %A Ramaiya,Megan %A Lara Salas,Jannet %A Ezimora,Ifunanya %A Shumway,Martha %A Duerr Berrick,Jill %A Aguilera,Adrian %A Borsari,Brian %A Dauria,Emily %A Friedling,Naomi %A Holmes,Crystal %A Grandi,Adam %+ Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, 1001 Potrero Ave, San Francisco, CA, 94110, United States, 1 415 361 1081, megan.ramaiya@ucsf.edu %K randomized clinical trial %K foster care %K child welfare–involved youth %K navigator interventions %K digital health technology %K implementation science %K community engagement %D 2023 %7 12.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Youth in the child welfare system (child welfare–involved [CWI] youth) have high documented rates of mental health symptoms and experience significant disparities in mental health care services access and engagement. Adolescence is a developmental stage that confers increased likelihood of experiencing mental health symptoms and the emergence of disorders that can persist into adulthood. Despite a high documented need for evidence-based mental health services for CWI youth, coordination between child welfare and mental health service systems to increase access to care remains inadequate, and engagement in mental health services is low. Navigator models developed in the health care field to address challenges of service access, fragmentation, and continuity that affect the quality of care provide a promising approach to increase linkage to, and engagement in, mental health services for CWI youth. However, at present, there is no empirically supported mental health navigator model to address the unique and complex mental health needs of CWI youth and their families. Objective: Using a randomized controlled trial, this study aims to develop and test a foster care family navigator (FCFN) model to improve mental health service outcomes for CWI adolescents (aged 12-17 years). Methods: The navigator model leverages an in-person navigator and use of adjunctive digital health technology to engage with, and improve, care coordination, tracking, and monitoring of mental health service needs for CWI youth and families. In total, 80 caregiver-youth dyads will be randomized to receive either the FCFN intervention or standard of care (clinical case management services): 40 (50%) to FCFN and 40 (50%) to control. Qualitative exit interviews will inform the feasibility and acceptability of the services received during the 6-month period. The primary trial outcomes are mental health treatment initiation and engagement. Other pre- and postservice outcomes, such as proportion screened and time to screening, will also be evaluated. We hypothesize that youth receiving the FCFN intervention will have higher rates of mental health treatment initiation and engagement than youth receiving standard of care. Results: We propose enrollment of 80 dyads by March 2024, final data collection by September 2024, and the publication of main findings in March 2025. After final data analysis and writing of the results, the resulting manuscripts will be submitted to journals for dissemination. Conclusions: This study will be the first to produce empirically driven conclusions and recommendations for implementing a family mental health navigation model for CWI youth with long-standing and unaddressed disparities in behavioral health services access. The study findings have potential to have large-scale trial applicability and be feasible and acceptable for eventual system implementation and adoption. Trial Registration: ClinicalTrials.gov NCT04506437; https://www.clinicaltrials.gov/study/NCT04506437 International Registered Report Identifier (IRRID): DERR1-10.2196/49999 %M 37698896 %R 10.2196/49999 %U https://www.researchprotocols.org/2023/1/e49999 %U https://doi.org/10.2196/49999 %U http://www.ncbi.nlm.nih.gov/pubmed/37698896 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46883 %T Evaluating a WeChat-Based Health Behavioral Digital Intervention for Patients With Hypertension: Protocol for a Randomized Controlled Trial %A Sun,Ting %A Zhao,Huanhuan %A Ding,Zenghui %A Xie,Hui %A Ma,Linlin %A Zhang,Yu %A Wang,Yingying %A Yang,Yinju %A Xu,Chunyi %A Sun,Yining %A Xu,Xuejie %A Ma,Zuchang %+ Institute of Intelligent Machines, Hefei Institutes of Physical Sciences, Chinese Academy of Sciences, 350# Shushan Lake Road, Hefei, 230031, China, 86 13956984669, ZCMa121@126.com %K adherence %K community health %K hypertension %K health behavior %K mobile phone %D 2023 %7 12.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Hypertension is the most prevalent chronic condition and a significant risk factor for cardiovascular and kidney diseases. The efficacy of health behavioral interventions in blood pressure (BP) control has been demonstrated by a large and expanding body of literature, with “adherence” playing a crucial role. WeChat is the most common social communication mobile app in China, and it has been shown to be an acceptable delivery platform for delivering health interventions. The WeChat-based health behavioral digital intervention program (WHBDIP) showed high feasibility and efficacy. However, the results regarding BP improvement between the WHBDIP and control groups were inconsistent. Objective: The objective of this study is to develop a WHBDIP and assess its efficacy in controlling BP and improving adherence among patients with hypertension. Methods: A 2-arm, parallel-group, and randomized trial design was used. Patients older than 60 years and with hypertension were randomly assigned to either the control group or the experimental group, which received a 12-week intervention. The program, primarily developed based on the Behavior Change Wheel (BCW) theory, offers health education on exercise, diet, BP monitoring, and medicine adherence (MA). It also includes other behavior interventions guided by an intervention manual, incorporating behavior change techniques (BCTs). The primary outcomes encompass BP and adherence indicators, while the secondary outcomes encompass cardiovascular function indicators, body composition indicators, learning performance, satisfaction, and acceptability. The exercise and blood pressure monitoring adherence (BPMA) indicators for the WHBDIP group were assessed weekly via WeChat during the initial 3 months, while other outcome data for both groups will be collected at the baseline assessment phase, 3 months after the intervention, and 1 year after the program. Results: The trial will assess the efficacy of WHBDIP for patients with hypertension (N=68). The WHBDIP seeks to enhance participants' knowledge of healthy behaviors and assist patients in developing positive health behaviors to improve their health outcomes. Patient recruitment for individuals with hypertension commenced on September 5, 2022, and concluded on September 19, 2022. The 3-month intervention and phased data collection were finalized in January 2023. Data analysis will commence in August 2023, and the final 1-year health outcome results will be collected in September 2023. Conclusions: A successful WHBDIP will establish the management mode as a feasible approach for hypertension management in the community. Additionally, it will pave the way for the development of related mobile health programs. Trial Registration: Chinese Clinical Trial Registry ChiCTR2200062643; https://tinyurl.com/mwyv67wk International Registered Report Identifier (IRRID): PRR1-10.2196/46883 %M 37698909 %R 10.2196/46883 %U https://www.researchprotocols.org/2023/1/e46883 %U https://doi.org/10.2196/46883 %U http://www.ncbi.nlm.nih.gov/pubmed/37698909 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46735 %T An eHealth Program for Insomnia in Children With Neurodevelopmental Disorders (Better Nights, Better Days): Protocol for an Economic Evaluation of a Randomized Controlled Trial %A Jia,Xiao Yang %A Andreou,Pantelis %A Brown,Cary %A Constantin,Evelyn %A Godbout,Roger %A Hanlon-Dearman,Ana %A Ipsiroglu,Osman %A Reid,Graham %A Shea,Sarah %A Smith,Isabel M %A Zwicker,Jennifer D %A Weiss,Shelly K %A Corkum,Penny %+ The School of Public Policy, University of Calgary, 5th Floor, 906 8th Avenue SW, Calgary, AB, T2P 1H9, Canada, 1 4032103802, xiaoyangsean.jia@ucalgary.ca %K eHealth intervention %K pediatric insomnia %K neurodevelopmental disorders %K attention-deficit/hyperactivity disorder %K autism spectrum disorder %K cerebral palsy %K fetal alcohol spectrum disorder %K economic evaluation %K cost-effectiveness %D 2023 %7 12.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Children with neurodevelopmental disorders have a high risk of sleep disturbances, with insomnia being the most common sleep disorder (ie, chronic and frequent difficulties with going and staying asleep). Insomnia adversely affects the well-being of these children and their caregivers. Pediatric sleep experts recommend behavioral interventions as the first-line treatment option for children. Better Nights, Better Days for Children with Neurodevelopmental Disorders (BNBD-NDD) is a 5-session eHealth behavioral intervention delivered to parents to improve outcomes (eg, Pediatric Quality of Life Inventory [PedsQL]) for their children (ages 4-12 years) with insomnia and who have a diagnosis of mild to moderate attention-deficit/hyperactivity disorder, autism spectrum disorder, cerebral palsy, or fetal alcohol spectrum disorder. If cost-effective, BNBD-NDD can be a scalable intervention that provides value to an underserved population. Objective: This protocol outlines an economic evaluation conducted alongside the BNBD-NDD randomized controlled trial (RCT) that aims to assess its costs, efficacy, and cost-effectiveness compared to usual care. Methods: The BNBD-NDD RCT evaluates the impacts of the intervention on children’s sleep and quality of life, as well as parents’ daytime functioning and psychosocial health. Parent participants were randomized to the BNBD-NDD treatment or to usual care. The economic evaluation assesses outcomes at baseline and 8 months later, which include the PedsQL as the primary measure. Quality of life outcomes facilitate the comparison of competing interventions across different populations and medical conditions. Cost items include the BNBD-NDD intervention and parent-reported usage of private and publicly funded resources for their children’s insomnia. The economic evaluation involves a reference case cost-effectiveness analysis to examine the incremental cost of BNBD-NDD per units gained in the PedsQL from the family payer perspective and a cost-consequence analysis from a societal perspective. These analyses will be conducted over an 8-month time horizon. Results: Research funding was obtained from the Kids Brain Health Network in 2015. Ethics were approved by the IWK Health Research Ethics Board and the University of Calgary Conjoint Health Research Ethics Board in January 2019 and June 2022, respectively. The BNBD-NDD RCT data collection commenced in June 2019 and ended in April 2022. The RCT data are currently being analyzed, and data relevant to the economic analysis will be analyzed concurrently. Conclusions: To our knowledge, this will be the first economic evaluation of an eHealth intervention for insomnia in children with neurodevelopmental disorders. This evaluation’s findings can inform users and stakeholders regarding the costs and benefits of BNBD-NDD. Trial Registration: ClinicalTrial.gov NCT02694003; https://clinicaltrials.gov/study/NCT02694003 International Registered Report Identifier (IRRID): DERR1-10.2196/46735 %M 37698915 %R 10.2196/46735 %U https://www.researchprotocols.org/2023/1/e46735 %U https://doi.org/10.2196/46735 %U http://www.ncbi.nlm.nih.gov/pubmed/37698915 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45170 %T A Digital System (YouXin) to Facilitate Self-Management by People With Psychosis in China: Protocol for a Nonrandomized Validity and Feasibility Study With a Mixed Methods Design %A Zhang,Xiaolong %A Lewis,Shôn %A Carter,Lesley-Anne %A Bucci,Sandra %+ Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, 2nd Floor, Zochonis Building, Brunswick Street, Manchester, M13 9PL, United Kingdom, 44 161 306 0422, Sandra.Bucci@manchester.ac.uk %K psychosis %K self-management %K digital %K smartphone app %K eHealth %K mHealth %K China %D 2023 %7 12.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Psychosis is one of the most disabling mental health conditions and causes significant personal, social, and economic burden. Accurate and timely symptom monitoring is critical to offering prompt and time-sensitive clinical services. Digital health is a promising solution for the barriers encountered by conventional symptom monitoring approaches, including accessibility, the ecological validity of assessments, and recall bias. However, to date, there has been no digital health technology developed to support self-management for people with psychosis in China. Objective: We report the study protocol to evaluate the validity, feasibility, acceptability, usability, and safety of a symptom self-monitoring smartphone app (YouXin; Chinese name 佑心) for people with psychosis in China. Methods: This is a nonrandomized validity and feasibility study with a mixed methods design. The study was approved by the University of Manchester and Beijing Anding Hospital Research Ethics Committee. YouXin is a smartphone app designed to facilitate symptom self-monitoring for people with psychosis. YouXin has 2 core functions: active monitoring of symptoms (ie, smartphone survey) and passive monitoring of behavioral activity (ie, passive data collection via embedded smartphone sensors). The development process of YouXin utilized a systematic coproduction approach. A series of coproduction consultation meetings was conducted by the principal researcher with service users and clinicians to maximize the usability and acceptability of the app for end users. Participants with psychosis aged 16 years to 65 years were recruited from Beijing Anding Hospital, Beijing, China. All participants were invited to use the YouXin app to self-monitor symptoms for 4 weeks. At the end of the 4-week follow-up, we invited participants to take part in a qualitative interview to explore the acceptability of the app and trial procedures postintervention. Results: Recruitment to the study was initiated in August 2022. Of the 47 participants who were approached for the study from August 2022 to October 2022, 41 participants agreed to take part in the study. We excluded 1 of the 41 participants for not meeting the inclusion criteria, leaving a total of 40 participants who began the study. As of December 2022, 40 participants had completed the study, and the recruitment was complete. Conclusions: This study is the first to develop and test a symptom self-monitoring app specifically designed for people with psychosis in China. If the study shows the feasibility of YouXin, a potential future direction is to integrate the app into clinical workflows to facilitate digital mental health care for people with psychosis in China. This study will inform improvements to the app, trial procedures, and implementation strategies with this population. Moreover, the findings of this trial could lead to optimization of digital health technologies designed for people with psychosis in China. International Registered Report Identifier (IRRID): DERR1-10.2196/45170 %M 37698905 %R 10.2196/45170 %U https://www.researchprotocols.org/2023/1/e45170 %U https://doi.org/10.2196/45170 %U http://www.ncbi.nlm.nih.gov/pubmed/37698905 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 8 %N %P e47638 %T Impact of a Combined Continuous Glucose Monitoring–Digital Health Solution on Glucose Metrics and Self-Management Behavior for Adults With Type 2 Diabetes: Real-World, Observational Study %A Kumbara,Abhimanyu B %A Iyer,Anand K %A Green,Courtney R %A Jepson,Lauren H %A Leone,Keri %A Layne,Jennifer E %A Shomali,Mansur %+ Welldoc, Inc, Suite #150, 10221 Wincopin Cir., Columbia, MD, 21044, United States, 1 443 692 3100, mshomali@welldocinc.com %K type 2 diabetes %K digital health %K continuous glucose monitoring %K artificial intelligence %K glycemic outcomes %K engagement %K digital health intervention %K mHealth %K diabetes management %D 2023 %7 11.9.2023 %9 Original Paper %J JMIR Diabetes %G English %X Background: The BlueStar (Welldoc) digital health solution for people with diabetes incorporates data from multiple devices and generates coaching messages using artificial intelligence. The BlueStar app syncs glucose data from the G6 (Dexcom) real-time continuous glucose monitoring (RT-CGM) system, which provides a glucose measurement every 5 minutes. Objective: The objective of this real-world study of people with type 2 diabetes (T2D) using the digital health solution and RT-CGM was to evaluate change in glycemic control and engagement with the program over 3 months. Methods: Participants were current or former enrollees in an employer-sponsored health plan, were aged 18 years or older, had a T2D diagnosis, and were not using prandial insulin. Outcomes included CGM-based glycemic metrics and engagement with the BlueStar app, including logging medications taken, exercise, food details, blood pressure, weight, and hours of sleep. Results: Participants in the program that met our analysis criteria (n=52) were aged a mean of 53 (SD 9) years; 37% (19/52) were female and approximately 50% (25/52) were taking diabetes medications. The RT-CGM system was worn 90% (SD 8%) of the time over 3 months. Among individuals with suboptimal glycemic control at baseline, defined as mean glucose >180 mg/dL, clinically meaningful improvements in glycemic control were observed, including reductions in a glucose management indicator (–0.8 percentage points), time above range 181-250 mg/dL (–4.4 percentage points) and time above range >250 mg/dL (–14 percentage points; all P<.05). Time in range 70-180 mg/dL also increased by 15 percentage points (P=.016) in this population, which corresponds to an increase of approximately 3.5 hours per day in the target range. Over the 3-month study, 29% (15/52) of participants completed at least one engagement activity per week. Medication logging was completed most often by participants (23/52, 44%) at a rate of 12.1 (SD 0.8) events/week, and this was closely followed by exercise and food logging. Conclusions: The combination of an artificial intelligence–powered digital health solution and RT-CGM helped people with T2D improve their glycemic outcomes and diabetes self-management behaviors. %M 37590491 %R 10.2196/47638 %U https://diabetes.jmir.org/2023/1/e47638 %U https://doi.org/10.2196/47638 %U http://www.ncbi.nlm.nih.gov/pubmed/37590491 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e47035 %T Remote Recruitment Strategy and Structured E-Parenting Support (STEPS) App: Feasibility and Usability Study %A Kostyrka-Allchorne,Katarzyna %A Chu,Petrina %A Ballard,Claire %A Lean,Nancy %A French,Blandine %A Hedstrom,Ellen %A Byford,Sarah %A Cortese,Samuele %A Daley,David %A Downs,Johnny %A Glazebrook,Cristine %A Goldsmith,Kimberley %A Hall,Charlotte L %A Kovshoff,Hanna %A Kreppner,Jana %A Sayal,Kapil %A Shearer,James %A Simonoff,Emily %A Thompson,Margaret %A Sonuga-Barke,Edmund J S %+ Department of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neuroscience, King's College London, 16 De Crespigny Park, London, SE58AF, United Kingdom, 44 02078483682, edmund.sonuga-barke@kcl.ac.uk %K parenting intervention %K mobile app %K attention-deficit/hyperactivity disorder %K ADHD %K behavior problems %K mobile health %K mHealth %K children %K usability %K mobile phone %D 2023 %7 11.9.2023 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: The Structured E-Parenting Support (STEPS) app provides support for parents of children with elevated hyperactivity, impulsivity, inattention, and conduct problems who are awaiting clinical assessment. STEPS will be evaluated in a randomized controlled trial (RCT) within the Online Parent Training for the Initial Management of ADHD Referrals (OPTIMA) research program in the United Kingdom. Phase 1 of the OPTIMA tested the feasibility of participants’ recruitment and the app’s usability. Objective: This study aimed to adapt a digital routine clinical monitoring system, myHealthE, for research purposes to facilitate waitlist recruitment; test using remote methods to screen and identify participants quickly and systematically; pilot the acceptability of the recruitment and assessment protocol; and explore the usability of STEPS. Methods: myHealthE was adapted to screen patients’ data. Parents’ and clinicians’ feedback on myHealthE was collected, and information governance reviews were conducted in clinical services planning to host the RCT. Potential participants for the observational feasibility study were identified from new referrals using myHealthE and non-myHealthE methods. Descriptive statistics were used to summarize the demographic and outcome variables. We estimated whether the recruitment rate would meet the planned RCT sample size requirement (n=352). In addition to the feasibility study participants, another group of parents was recruited to assess the STEPS usability. They completed the adapted System Usability Scale and responded to open-ended questions about the app, which were coded using the Enlight quality construct template. Results: Overall, 124 potential participants were identified as eligible: 121 (97.6%) via myHealthE and 3 (2.4%) via non-myHealthE methods. In total, 107 parents were contacted, and 48 (44.9%) consented and were asked if, hypothetically, they would be willing to participate in the OPTIMA RCT. Of the 28 feasibility study participants who provided demographic data, 21 (75%) identified as White. Their children had an average age of 8.4 (SD 1.7) years and 65% (31/48) were male. During the primary recruitment period (June to July 2021) when 45 participants had consented, 38 (84%) participants agreed hypothetically to take part in the RCT (rate of 19/mo, 95% CI 13.5-26.1), meeting the stop-go criterion of 18 participants per month to proceed with the RCT. All parents were satisfied or very satisfied with the study procedures. Parents (n=12) recruited to assess STEPS’ usability described it as easy to navigate and use and as having an attractive combination of colors and visual design. They described the content as useful, pitched at the right level, and sensitively presented. Suggested improvements included adding captions to videos or making the recorded reflections editable. Conclusions: Remote recruitment and study procedures for testing a parenting intervention app are feasible and acceptable for parents. The parents felt that STEPS was a useful and easy-to-use digital parenting support tool. International Registered Report Identifier (IRRID): RR2-10.1186/s40814-021-00959-0 %M 37695667 %R 10.2196/47035 %U https://pediatrics.jmir.org/2023/1/e47035 %U https://doi.org/10.2196/47035 %U http://www.ncbi.nlm.nih.gov/pubmed/37695667 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e40560 %T Segmenting Patients With Diabetes With the Navigator Service in Primary Care and a Description of the Self-Acting Patient Group: Cross-Sectional Study %A Riihimies,Riikka %A Kosunen,Elise %A Koskela,Tuomas H %+ Faculty of Medicine and Health Technology, Tampere University, Arvo Building, Arvo Ylpön katu 34, Tampere, 33520, Finland, 358 505262556, riikka.riihimies@tuni.fi %K patient segmentation %K Navigator %K self-acting patient %K diabetes %K primary care %K self-management %K skills %K care %K nurse %K medication %K quality of life %K well-being %K digital %K patient %D 2023 %7 8.9.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: The aim of patient segmentation is to recognize patients with similar health care needs. The Finnish patient segmentation service Navigator segregates patients into 4 groups, including a self-acting group, who presumably manages their everyday life and coordinates their health care. Digital services could support their self-care. Knowledge on self-acting patients’ characteristics is lacking. Objective: The study aims are to describe how Navigator assigns patients with diabetes to the 4 groups at nurses’ appointments at a health center, the self-acting patient group’s characteristics compared with other patient groups, and the concordance between the nurse’s evaluation of the patient’s group and the actual group assigned by Navigator (criterion validity). Methods: Patients with diabetes ≥18 years old visiting primary care were invited to participate in this cross-sectional study. Patients with disability preventing informed consent for participation were excluded. Nurses estimated the patients’ upcoming group results before the appointment. We describe the concordance (%) between the evaluation and actual groups. Nurses used Navigator patients with diabetes (n=304) at their annual follow-up visits. The self-acting patients’ diabetes care values (glycated hemoglobin [HbA1c], urine albumin to creatinine ratio, low-density lipoprotein cholesterol, blood pressure, BMI), chronic conditions, medication, smoking status, self-rated health, disability (World Health Organization Disability Assessment Schedule [WHODAS] 2.0), health-related quality of life (EQ-5D-5L), and well-being (Well-being Questionnaire [WBQ-12]) and the patients’ responses to Navigator’s question concerning their digital skills as outcome variables were compared with those of the other patients. We used descriptive statistics for the patients’ distribution into the 4 groups and demographic data. We used the Mann-Whitney U test with nonnormally distributed variables, independent samples t test with normally distributed variables, and Pearson chi-square tests with categorized variables to compare the groups. Results: Most patients (259/304, 85.2%) were in the self-acting group. Hypertension, hyperlipidemia, and joint ailments were the most prevalent comorbidities among all patients. Self-acting patients had less ischemic cardiac disease (P=.001), depression or anxiety (P=.03), asthma or chronic obstructive pulmonary disease (P<.001), long-term pain (P<.001), and related medication. Self-acting patients had better self-rated health (P<.001), functional ability (P<.001), health-related quality of life (P<.001), and general well-being (P<.001). All patients considered their skills at using electronic services to be good. Conclusions: The patients in the self-acting group had several comorbidities. However, their functional ability was not yet diminished compared with patients in the other groups. Therefore, to prevent diabetic complications and disabilities, support for patients’ self-management should be emphasized in their integrated care services. Digital services could be involved in the care of patients willing to use them. The study was performed in 1 health center, the participants were volunteers, and most patients were assigned to self-acting patient group. These facts limit the generalizability of our results. International Registered Report Identifier (IRRID): RR2-10.2196/20570 %M 37682585 %R 10.2196/40560 %U https://www.jmir.org/2023/1/e40560 %U https://doi.org/10.2196/40560 %U http://www.ncbi.nlm.nih.gov/pubmed/37682585 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46081 %T Older Veterans’ Experiences of a Multicomponent Telehealth Program: Qualitative Program Evaluation Study %A Rauzi,Michelle R %A Mealer,Meredith L %A Abbate,Lauren M %A Stevens-Lapsley,Jennifer E %A Nearing,Kathryn A %+ Physical Therapy Program, Department of Physical Medicine and Rehabilitation, University of Colorado, 13121 E 17th Ave, Aurora, CO, 80045, United States, 1 303 724 9590, michelle.rauzi@cuanschutz.edu %K telehealth %K multimorbidity %K older adults %K veteran health %K physical therapy %D 2023 %7 8.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: There are 8.8 million American veterans aged >65 years. Older veterans often have multiple health conditions that increase their risk of social isolation and loneliness, disability, adverse health events (eg, hospitalization and death), mental illness, and heavy health care use. This population also exhibits low levels of physical function and daily physical activity, which are factors that can negatively influence health. Importantly, these are modifiable risk factors that are amenable to physical therapy intervention. We used a working model based on the dynamic biopsychosocial framework and social cognitive theory to conceptualize the multifactorial needs of older veterans with multiple health conditions and develop a novel, 4-component telehealth program to address their complex needs. Objective: This study aims to describe veterans’ experiences of a multicomponent telehealth program and identify opportunities for quality and process improvement. We conducted qualitative interviews with telehealth program participants to collect their feedback on this novel program; explore their experience of program components; and document perceived outcomes and the impact on their daily life, relationships, and quality of life. Methods: As part of a multimethod program evaluation, semistructured interviews were conducted with key informants who completed ≥8 weeks of the 12-week multicomponent telehealth program for veterans aged ≥50 years with at least 3 medical comorbidities. Interviews were audio recorded and transcribed. Data were analyzed by a team of 2 coders using a directed content analysis approach and Dedoose software was used to assist with data analysis. Results: Of the 21 individuals enrolled in the program, 15 (71%) met the inclusion criteria for interviews. All 15 individuals completed 1-hour interviews. A total of 6 main conceptual domains were identified: technology, social networks, therapeutic relationship, patient attributes, access, and feasibility. Themes associated with each domain detail participant experiences of the telehealth program. Key informants also provided feedback related to different components of the program, leading to adaptations for the biobehavioral intervention, group sessions (transition from individual to group sessions and group session dynamics), and technology supports. Conclusions: Findings from this program evaluation identified quality and process improvements, which were made before rigorously testing the intervention in a larger population through a randomized controlled trial. The findings may inform adaptations of similar programs in different contexts. Further research is needed to develop a deeper understanding of how program components influence social health and longer-term behavior change. %M 37682595 %R 10.2196/46081 %U https://formative.jmir.org/2023/1/e46081 %U https://doi.org/10.2196/46081 %U http://www.ncbi.nlm.nih.gov/pubmed/37682595 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e50993 %T Using IT to Improve Outcomes for Children Living With Cancer (SyMon-SAYS): Protocol for a Single-Institution Waitlist Randomized Controlled Trial %A Lai,Jin-Shei %A Jensen,Sally E %A Peipert,John Devin %A Mitchell,Sandra A %A Garcia,Sofia F %A Cella,David %A Goldman,Stewart %A Lenzen,Alicia %+ Medical Social Sciences, Feinberg School of Medicine, Northwestern University, 625 N. Michigan Ave, 21st Floor, Chicago, IL, 60611, United States, 1 312 503 3370, js-lai@northwestern.edu %K pediatric, cancer %K symptom monitoring %K randomized controlled trial %K protocol, electronic health record %K health-related quality of life %D 2023 %7 8.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Children and adolescents with cancer may experience multiple disease- and treatment-related symptoms that negatively affect health-related quality of life. Routine symptom surveillance thus constitutes an important component of supportive care in pediatric oncology. The Symptom Monitoring and Systematic Assessment and Reporting System in Young Survivors (SyMon-SAYS) system will administer, score, interpret, and display the results of symptom assessments captured weekly using patient-reported outcomes presented via the electronic health record (EHR) portal between clinic visits in oncology ambulatory settings, when patients are likely to be more symptomatic. This study is testing a digital system for routine symptom surveillance that includes EHR-based reports to clinicians and alerts for severe symptoms. Objective: In this randomized trial, we are examining the effects of the SyMon-SAYS system on perceived barriers to symptom management, self-efficacy, and symptom severity. Better self-management and timely clinical intervention to address symptoms promote adherence to treatment plans, strengthen child and parent self-efficacy, improve interactions between children, parents, and their clinical providers, and optimize clinical outcomes. Methods: The SyMon-SAYS system is integrated into the EHR to streamline the presentation of symptom scores and delivery of alerts for severe symptoms to clinicians using EHR (Epic) messaging functionalities. Children (aged 8 to 17 years) complete the weekly symptom assessment and review the symptom report by logging into the patient portal (Epic MyChart). This single-institution waitlist randomized controlled trial is recruiting 200 children (aged 8-17 years) with cancer and their parents, guardians, or caregivers. Participating dyads are randomly assigned to receive the intervention over 16 weeks (Group A: 16-week SyMon-SAYS intervention; Group B: 8-week usual care and then an 8-week SyMon-SAYS intervention). Analyses will (1) evaluate the efficacy of SyMon-SAYS at week 8 and the maintenance of those effects at week 16; (2) evaluate factors associated with those efficacy outcomes, including contextual factors, adherence to the SyMon-SAYS intervention, demographic characteristics, and clinical factors; and (3) evaluate predictors of adherence to the SyMon-SAYS intervention and preference of SyMon-SAYS versus usual care. Results: Data collection is currently in progress. We hypothesize that at 8 weeks, those receiving the SyMon-SAYS intervention will report decreased parent-perceived barriers to managing their children’s symptoms, increased parent and child self-efficacy, decreased child symptom burden, and ultimately better child health-related quality of life, compared to waitlist controls. Feasibility, acceptability, and engagement from the perspectives of the children with cancer, their parents, and their clinicians will be examined using mixed methods. Conclusions: We anticipate that this system will facilitate prompt identification of problematic symptoms. Additionally, we hypothesize that with the availability of graphical symptom reports over time, and timely provider responses, children or parents will become better informed and take an active role in managing their symptoms, which will further improve clinical outcomes. Trial Registration: ClinicalTrials.gov NCT04789720; https://clinicaltrials.gov/study/NCT04789720 International Registered Report Identifier (IRRID): DERR1-10.2196/50993 %M 37682593 %R 10.2196/50993 %U https://www.researchprotocols.org/2023/1/e50993 %U https://doi.org/10.2196/50993 %U http://www.ncbi.nlm.nih.gov/pubmed/37682593 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49020 %T Wellness in Nursing Education to Promote Resilience and Reduce Burnout: Protocol for a Holistic Multidimensional Wellness Intervention and Longitudinal Research Study Design in Nursing Education %A Strout,Kelley %A Schwartz-Mette,Rebecca %A McNamara,Jade %A Parsons,Kayla %A Walsh,Dyan %A Bonnet,Jen %A O'Brien,Liam M %A Robinson,Kathryn %A Sibley,Sean %A Smith,Annie %A Sapp,Maile %A Sprague,Lydia %A Sabegh,Nima Sajedi %A Robinson,Kaitlin %A Henderson,Amanda %+ School of Nursing, University of Maine, Dunn Hall, Orono, ME, 04469, United States, 1 2075812601, kelley.strout@maine.edu %K nursing workforce %K academic performance %K burnout %K resilience %K wellness %K nursing %K education %K nursing education %K protocol %K nursing students %K students %K holistic %K implementation %K workforce %D 2023 %7 8.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: The United States faces a nursing shortage driven by a burnout epidemic among nurses and nursing students. Nursing students are an integral population to fuel the nursing workforce at high risk of burnout and increased rates of perceived stress. Objective: The aim of this paper is to describe WellNurse, a holistic, interdisciplinary, multidimensional longitudinal research study that examines evidence-based interventions intended to reduce burnout and increase resilience among graduate and undergraduate nursing students. Methods: Graduate and undergraduate nursing students matriculated at a large public university in the northeastern United States are eligible to enroll in this ongoing, longitudinal cohort study beginning in March 2021. Participants complete a battery of health measurements twice each semester during the fourth week and the week before final examinations. The measures include the Perceived Stress Scale, the Satisfaction with Life Scale, the Oldenburg Burnout Inventory, the Brief Resilience Scale, and the Pittsburgh Sleep Quality Index. Participants are eligible to enroll in a variety of interventions, including mindfulness-based stress reduction, mindful eating, fitness training, and massage therapy. Those who enroll in specific, targeted interventions complete additional measures designed to target the aim of the intervention. All participants receive a free Fitbit device. Additional environmental changes are being implemented to further promote a culture that supports academic well-being, including recruiting a diverse student population through evidence-based holistic admissions, inclusive teaching design, targeted resilience and stress reduction workshops, and cultural shifts within classrooms and curricula. The study design protocol is registered at Open Science Framework DOI 10.17605/OSF.IO/NCBPE. Results: The project was funded on January 1, 2022. Data collection started in March 2022. A total of 267 participants have been recruited. Results will be published after each semester starting in December 2023. WellNurse evaluation follows the Rapid Cycle Quality Improvement framework to continuously monitor ongoing project processes, activity outcomes, and progress toward reducing burnout and increasing resilience. Rapid Cycle Quality Improvement promotes the ability to alter WellNurse interventions, examine multiple interventions, and test their effectiveness among the nursing education population to identify the most effective interventions. Conclusions: Academic nursing organizations must address student burnout risk and increase resilience to produce a future workforce that provides high-quality patient care to a diverse population. Findings from WellNurse will support evidence-based implementations for public baccalaureate and master’s nursing programs in the United States. International Registered Report Identifier (IRRID): DERR1-10.2196/49020 %R 10.2196/49020 %U https://www.researchprotocols.org/2023/1/e49020/ %U https://doi.org/10.2196/49020 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 9 %N %P e47187 %T Effectiveness of a Self-Monitoring App in Supporting Physical Activity Maintenance Among Rural Canadians With Cancer After an Exercise Oncology Program: Cluster Randomized Controlled Trial %A Ester,Manuel %A Wagoner,Chad W %A Dreger,Julianna %A Chen,Guanmin %A McDonough,Meghan H %A McNeely,Margaret L %A Culos-Reed,S Nicole %+ Faculty of Kinesiology, University of Calgary, 2500 University Dr. NW, Calgary, AB, T2N 1N4, Canada, 1 4032108482, manuel.ester@ucalgary.ca %K eHealth %K mHealth %K mobile health %K mobile apps %K self-monitoring %K cancer %K oncology %K physical activity %K exercise %K randomized controlled trial %K intervention %K mobile phone %D 2023 %7 7.9.2023 %9 Original Paper %J JMIR Cancer %G English %X Background: Despite the benefits of physical activity (PA) for individuals with cancer, most remain insufficiently active. Exercise oncology interventions can improve PA levels. Individuals struggle to maintain PA levels after interventions because of persistent psychological and environmental PA barriers. Health technology (eHealth) may address some PA barriers and deliver effective, scalable PA interventions in oncology, yet its effectiveness for changing PA levels remains mixed. Using eHealth to support PA maintenance among rural populations with cancer, who may need greater PA support given lower PA levels and worse health outcomes, remains under-studied. Objective: This study examined the effectiveness of an app-based self-monitoring intervention in supporting PA maintenance among rural populations with cancer after a supervised web-based exercise oncology program. Methods: This 2-arm, cluster randomized controlled trial was embedded within the Exercise for Cancer to Enhance Living Well (EXCEL) effectiveness-implementation study. Upon consent, participants were randomized 1:1 by EXCEL class clusters to the intervention (24 weeks of app-based PA self-monitoring) or waitlist control (app access after 24 weeks). Both groups completed a 12-week supervised web-based exercise oncology program followed by a 12-week self-directed PA maintenance period. Baseline demographics, eHealth literacy, and patient-reported outcomes were compared using chi-square and 2-tailed t tests. App use was measured throughout the intervention. The primary outcome—self-reported moderate-to-vigorous PA (MVPA) minutes—and secondary outcomes—objective MVPA minutes and steps and app usability ratings—were collected at baseline, 12 weeks, and 24 weeks. Intervention effects on self-report MVPA maintenance were assessed via linear mixed modeling, with secondary outcomes explored descriptively. Results: Of the 359 eligible EXCEL participants, 205 (57.1%) consented, 199 (55.4%; intervention: 106/199, 53.3%; control: 93/199, 46.7%) started the study, and 183 (51%; intervention: 100/183, 54.6%; control: 83/183, 45.4%) and 141 (39.3%; intervention: 69/141, 48.9%; control: 72/141, 51.1%) completed 12- and 24-week measures, respectively. Mean age was 57.3 (SD 11.5) years. Most participants were female (174/199, 87.4%), White (163/199, 81.9%), and diagnosed with breast cancer (108/199, 54.3%). Median baseline self-report weekly MVPA minutes were 60.0 (IQR 0-180) and 40.0 (IQR 0-135) for the intervention and waitlist control groups, respectively (P=.74). Median app use duration was 10.3 (IQR 1.3-23.9) weeks, with 9.6 (IQR 4.4-17.8) self-monitoring entries/week. Both groups increased their weekly MVPA minutes significantly at 12 weeks (P<.001) and maintained the increases at 24 weeks (P<.001), relative to baseline, with no between-group differences (P=.87). The intervention group had significantly higher step counts for 7 of the 12 weeks during the PA maintenance period (P=.048 to <.001). Conclusions: The app-based self-monitoring intervention did not improve MVPA maintenance but may have contributed to increased step counts during the PA maintenance period. More work is needed to realize the full potential of eHealth in exercise oncology. Trial Registration: ClinicalTrials.gov NCT04790578; https://clinicaltrials.gov/study/NCT04790578 International Registered Report Identifier (IRRID): RR2-10.1016/j.cct.2021.106474 %M 37676714 %R 10.2196/47187 %U https://cancer.jmir.org/2023/1/e47187 %U https://doi.org/10.2196/47187 %U http://www.ncbi.nlm.nih.gov/pubmed/37676714 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47917 %T Predicting Youth and Young Adult Treatment Engagement in a Transdiagnostic Remote Intensive Outpatient Program: Latent Profile Analysis %A Gliske,Kate %A Berry,Katie R %A Ballard,Jaime %A Schmidt,Clare %A Kroll,Elizabeth %A Kohlmeier,Jonathan %A Killian,Michael %A Fenkel,Caroline %+ Charlie Health Inc, 233 E Main St, Ste 233, Bozeman, MT, 59715-5045, United States, 1 9523341411, kgliske@umn.edu %K youth %K young adult %K virtual %K mental health %K intensive outpatient treatment %K latent profile analysis %K personalized treatment %D 2023 %7 7.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The youth mental health crisis in the United States continues to worsen, and research has shown poor mental health treatment engagement. Despite the need for personalized engagement strategies, there is a lack of research involving youth. Due to complex youth developmental milestones, there is a need to better understand clinical presentation and factors associated with treatment engagement to effectively identify and tailor beneficial treatments. Objective: This quality improvement investigation sought to identify subgroups of clients attending a remote intensive outpatient program (IOP) based on clinical acuity data at intake, to determine the factors associated with engagement outcomes for clients who present in complex developmental periods and with cooccurring conditions. The identification of these subgroups was used to inform programmatic decisions within this remote IOP system. Methods: Data were collected as part of ongoing quality improvement initiatives at a remote IOP for youth and young adults. Participants included clients (N=2924) discharged between July 2021 and February 2023. A latent profile analysis was conducted using 5 indicators of clinical acuity at treatment entry, and the resulting profiles were assessed for associations with demographic factors and treatment engagement outcomes. Results: Among the 2924 participants, 4 profiles of clinical acuity were identified: a low-acuity profile (n=943, 32.25%), characterized by minimal anxiety, depression, and self-harm, and 3 high-acuity profiles defined by moderately severe depression and anxiety but differentiated by rates of self-harm (high acuity+low self-harm: n=1452, 49.66%; high acuity+moderate self-harm: n=203, 6.94%; high acuity+high self-harm: n=326, 11.15%). Age, gender, transgender identity, and sexual orientation were significantly associated with profile membership. Clients identified as sexually and gender-marginalized populations were more likely to be classified into high-acuity profiles than into the low-acuity profile (eg, for clients who identified as transgender, high acuity+low self-harm: odds ratio [OR] 2.07, 95% CI 1.35-3.18; P<.001; high acuity+moderate self-harm: OR 2.85, 95% CI 1.66-4.90; P<.001; high acuity+high self-harm: OR 3.67, 95% CI 2.45-5.51; P<.001). Race was unrelated to the profile membership. Profile membership was significantly associated with treatment engagement: youth and young adults in the low-acuity and high-acuity+low–self-harm profiles attended an average of 4 fewer treatment sessions compared with youth in the high-acuity+moderate–self-harm and high-acuity+high–self-harm profiles (ꭓ23=27.6, P<.001). Individuals in the high-acuity+low–self-harm profile completed treatment at a significantly lower rate relative to the other 2 high-acuity profiles (ꭓ23=13.4, P=.004). Finally, those in the high-acuity+high–self-harm profile were significantly less likely to disengage early relative to youth in all other profiles (ꭓ23=71.12, P<.001). Conclusions: This investigation represents a novel application for identifying subgroups of adolescents and young adults based on clinical acuity data at intake to identify patterns in treatment engagement outcomes. Identifying subgroups that differentially engage in treatment is a critical first step toward targeting engagement strategies for complex populations. %M 37676700 %R 10.2196/47917 %U https://formative.jmir.org/2023/1/e47917 %U https://doi.org/10.2196/47917 %U http://www.ncbi.nlm.nih.gov/pubmed/37676700 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e41682 %T Community-Engaged Participatory Methods to Address Lesbian, Gay, Bisexual, Transgender, Queer, and Questioning Young People’s Health Information Needs With a Resource Website: Participatory Design and Development Study %A Delmonaco,Daniel %A Li,Shannon %A Paneda,Christian %A Popoff,Elliot %A Hughson,Luna %A Jadwin-Cakmak,Laura %A Alferio,Jack %A Stephenson,Christian %A Henry,Angelique %A Powdhar,Kiandra %A Gierlinger,Isabella %A Harper,Gary W %A Haimson,Oliver L %+ University of Michigan, 105 S State St, Ann Arbor, MI, 48109, United States, 1 734 764 5876, haimson@umich.edu %K lesbian, gay, bisexual, transgender, and queer health %K LGBTQ+ health %K information seeking %K participatory design %K community-based research %K web-based health resources %K lesbian, gay, bisexual, transgender, and queer young people %K LGBTQ+ young people %K mobile phone %D 2023 %7 7.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Lesbian, gay, bisexual, transgender, queer, and questioning (LGBTQ+) young people (aged 15 to 25 years) face unique health challenges and often lack resources to adequately address their health information needs related to gender and sexuality. Beyond information access issues, LGBTQ+ young people may need information resources to be designed and organized differently compared with their cisgender and heterosexual peers and, because of identity exploration, may have different information needs related to gender and sexuality than older people. Objective: The objective of our study was to work with a community partner to develop an inclusive and comprehensive new website to address LGBTQ+ young people’s health information needs. To design this resource website using a community-engaged approach, our objective required working with and incorporating content and design recommendations from young LGBTQ+ participants. Methods: We conducted interviews (n=17) and participatory design sessions (n=11; total individual participants: n=25) with LGBTQ+ young people to understand their health information needs and elicit design recommendations for the new website. We involved our community partner in all aspects of the research and design process. Results: We present participants’ desired resources, health topics, and technical website features that can facilitate information seeking for LGBTQ+ young people exploring their sexuality and gender and looking for health resources. We describe how filters can allow people to find information related to intersecting marginalized identities and how dark mode can be a privacy measure to avoid unwanted identity disclosure. We reflect on our design process and situate the website development in previous critical reflections on participatory research with marginalized communities. We suggest recommendations for future LGBTQ+ health websites based on our research and design experiences and final website design, which can enable LGBTQ+ young people to access information, find the right information, and navigate identity disclosure concerns. These design recommendations include filters, a reduced number of links, conscientious choice of graphics, dark mode, and resources tailored to intersecting identities. Conclusions: Meaningful collaboration with community partners throughout the design process is vital for developing technological resources that meet community needs. We argue for community partner leadership rather than just involvement in community-based research endeavors at the intersection of human-computer interaction and health. %M 37676709 %R 10.2196/41682 %U https://formative.jmir.org/2023/1/e41682 %U https://doi.org/10.2196/41682 %U http://www.ncbi.nlm.nih.gov/pubmed/37676709 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43825 %T Leveraging the Black Girls Run Web-Based Community as a Supportive Community for Physical Activity Engagement: Mixed Methods Study %A Kalinowski,Jolaade %A Idiong,Christie %A Blackman-Carr,Loneke %A Cooksey Stowers,Kristen %A Davis,Shardé %A Pan,Cindy %A Chhabra,Alisha %A Eaton,Lisa %A Gans,Kim M %A Alexander,Jay Ell %A Pagoto,Sherry %+ Department of Human Development and Family Sciences, The University of Connecticut, 348 Mansfield Rd, Storrs, CT, 06269, United States, 1 2032518421, jolaade.kalinowski@uconn.edu %K physical activity %K social media %K women’s health %K African American women %K mHealth %K mobile health %K Facebook %K African American %K exercise %K web-based community %K web-based communities %K content analysis %D 2023 %7 7.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: About 59%-73% of Black women do not meet the recommended targets for physical activity (PA). PA is a key modifiable lifestyle factor that can help mitigate risk for chronic diseases such as obesity, diabetes, and hypertension that disproportionately affect Black women. Web-based communities focused on PA have been emerging in recent years as web-based gathering spaces to provide support for PA in specific populations. One example is Black Girls Run (BGR), which is devoted to promoting PA in Black women. Objective: The purpose of this study was to describe the content shared on the BGR public Facebook page to provide insight into how web-based communities engage Black women in PA and inform the development of web-based PA interventions for Black women. Methods: Using Facebook Crowdtangle, we collected posts (n=397) and associated engagement data from the BGR public Facebook page for the 6-month period between June 1, 2021, and December 31, 2021. We pooled data in Dedoose to analyze the qualitative data and conducted a content analysis of qualitative data. We quantified types of posts, post engagement, and compared post types on engagement: “like,” “love,” “haha,” “wow,” “care,” “sad,” “angry,” “comments,” and “shares.” Results: The content analysis revealed 8 categories of posts: shout-outs to members for achievements (n=122, 31%), goals or motivational (n=65, 16%), announcements (n=63, 16%), sponsored or ads (n=54, 14%), health related (n=47, 11%), the lived Black experience (n=23, 6%), self-care (n=15, 4%), and holidays or greetings (n=8, 2%). The 397 posts attracted a total of 55,354 engagements (reactions, comments, and shares). Associations between the number of engagement and post categories were analyzed using generalized linear models. Shout-out posts (n=22,268) elicited the highest average of total user engagement of 181.7 (SD 116.7), followed by goals or motivational posts (n=11,490) with an average total engagement of 160.1 (SD 125.2) and announcements (n=7962) having an average total engagement of 129.9 (SD 170.7). Significant statistical differences were found among the total engagement of posts (χ72=80.99, P<.001), “like” (χ72=119.37, P<.001), “love” (χ72=63.995, P<.001), “wow” (χ72=23.73, P<.001), “care” (χ72=35.06, P<.001), “comments” (χ72=80.55, P<.001), and “shares” (χ72=71.28, P<.001). Conclusions: The majority of content on the BGR Facebook page (n=250, 63%) was focused on celebrating member achievements, motivating members to get active, and announcing and promoting active events. These types of posts attracted 75% of total post engagement. BGR appears to be a rich web-based community that offers social support for PA as well as culturally relevant health and social justice content. Web-based communities may be uniquely positioned to engage minoritized populations in health behavior. Further research should explore how and if web-based communities such as BGR can be interwoven into health interventions and health promotion. %M 37676722 %R 10.2196/43825 %U https://formative.jmir.org/2023/1/e43825 %U https://doi.org/10.2196/43825 %U http://www.ncbi.nlm.nih.gov/pubmed/37676722 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49752 %T Reminiscence and Digital Storytelling to Improve the Social and Emotional Well-Being of Older Adults With Alzheimer’s Disease and Related Dementias: Protocol for a Mixed Methods Study Design and a Randomized Controlled Trial %A Xu,Ling %A Fields,Noelle L %A Daniel,Kathryn M %A Cipher,Daisha J %A Troutman,Brooke A %+ School of Social Work, University of Texas at Arlington, 501 W Mitchell Street, Arlington, TX, 76010, United States, 1 817 272 3181, lingxu@uta.edu %K Alzheimer’s disease and related dementias %K ADRD %K digital storytelling %K DST %K intergenerational reminiscence %K older adult %K young adult %K randomized controlled trial %D 2023 %7 7.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Increasing attention is being given to the growing concerns about social isolation, loneliness, and compromised emotional well-being experienced by young adults and older individuals affected by Alzheimer disease and related dementias (ADRD). Studies suggest that reminiscence strategies combined with an intergenerational approach may yield significant social and mental health benefits for participants. Experts also recommended the production of a digital life story book as part of reminiscence. Reminiscence is typically implemented by trained professionals (eg, social workers and nurses); however, there has been growing interest in using trained volunteers owing to staffing shortages and the costs associated with reminiscence programs. Objective: The proposed study will develop and test how reminiscence offered by trained young adult volunteers using a digital storytelling platform may help older adults with ADRD to improve their social and emotional well-being. Methods: The proposed project will conduct a randomized controlled trial to assess the effects of the intervention. The older and young adult participants will be randomly assigned to the intervention (reminiscence based) or control groups and then be randomly matched within each group. Data will be collected at baseline before the intervention, in the middle of the intervention, at end of the intervention, and at 3 months after the intervention. An explanatory sequential mixed methods design will be used to take advantage of the strengths of both quantitative and qualitative methods. The quantitative data from surveys will be entered into SPSS and analyzed using covariate-adjusted linear mixed models for repeated measures to compare the intervention and control groups over time on the major outcomes of participants. Conventional content analysis of qualitative interviews will be conducted using data analysis software. Results: The project was modified to a telephone-based intervention owing to the COVID-19 pandemic. Data collection started in 2020 and ended in 2022. In total, 103 dyads were matched at the beginning of the intervention. Of the 103 dyads, 90 (87.4%) dyads completed the midtest survey and 64 (62.1%) dyads completed the whole intervention and the posttest survey. Although we are still cleaning and finalizing data analyses, the preliminary results from both quantitative and qualitative data showed promising results of this intergenerational reminiscence approach that benefits both the older adults who have cognitive impairments and the young adult participants. Conclusions: Intergenerational reminiscence provided by young adult college student offers promising benefits for both the younger and older generations. Future studies may consider scaling up this pilot into a trackable, replicable model that includes more participants with diverse background (eg, public vs private college students and older adults from other agencies) to test the effectiveness of this intervention for older adults with ADRD. Trial Registration: ClinicalTrials.gov NCT05984732; https://classic.clinicaltrials.gov/ct2/show/NCT05984732 International Registered Report Identifier (IRRID): DERR1-10.2196/49752 %M 37676706 %R 10.2196/49752 %U https://www.researchprotocols.org/2023/1/e49752 %U https://doi.org/10.2196/49752 %U http://www.ncbi.nlm.nih.gov/pubmed/37676706 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e47722 %T Moderated Online Social Therapy for Carers of Early Psychosis Clients in Real-World Settings: Cluster Randomized Controlled Trial %A Gleeson,John %A Lin,Ashleigh %A Koval,Peter %A Hopkins,Liza %A Denborough,Paul %A Lederman,Reeva %A Herrman,Helen %A Bendall,Sarah %A Eleftheriadis,Dina %A Cotton,Sue %A Perry,Yael %A Kaess,Michael %A Alvarez-Jimenez,Mario %+ Healthy Brain and Mind Research Centre, School of Behavioural and Health Sciences, Australian Catholic University, Level 5, Daniel Mannix Building, Young Street, Fitzroy, 3065, Australia, 61 39953 3108, john.gleeson@acu.edu.au %K first-episode psychosis %K carers %K eHealth %K families %K stress %K psychosis %K digital mental health intervention %K web-based therapy %K social therapy %D 2023 %7 6.9.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Family carers of youth recovering from early psychosis experience significant stress; however, access to effective family interventions is poor. Digital interventions provide a promising solution. Objective: Our objective was to evaluate across multiple Australian early psychosis services the effectiveness of a novel, web-based early psychosis intervention for carers. Methods: In this cluster randomized controlled trial conducted across multiple Australian early psychosis services, our digital moderated online social therapy for carers (Altitudes) plus enhanced family treatment as usual (TAU) was compared with TAU alone on the primary outcome of perceived stress and secondary outcomes including mental health symptoms and family variables at the 6-month follow-up. Results: Eighty-six caregivers were randomized and data were available for 74 young people in their care. Our primary hypothesis that carers randomized to Altitudes+TAU would report greater improvements in perceived stress at follow-up compared with carers randomized to TAU alone was not supported, with the TAU alone group showing more improvement. For secondary outcomes, the TAU alone group showed improved mindfulness over time. Regardless of group assignment, we observed improvements in satisfaction with life, quality of life, emotional overinvolvement, and burden of care. In contrast, hair cortisol concentration increased. Post hoc analyses revealed more contact with early psychosis services in the intervention group compared to TAU alone and that improvements in perceived stress and social support were associated with use of the intervention in the Altitudes+TAU group. In this study, 80% (12/15) reported a positive experience with Altitudes and 93% (14/15) would recommend it to others. Conclusions: Our trial did not show a treatment effect for Altitudes in perceived stress. However, our post hoc analysis indicated that the amount of use of Altitudes related to improvements in stress and social support. Additional design work is indicated to continue users’ engagement and to significantly improve outcomes in problem-solving, communication, and self-care. Trial Registration: Australian and New Zealand Clinical Trials Registry ACTRN12617000942358; https://trialsearch.who.int/Trial2.aspx?TrialID=ACTRN12617000942358 %M 37672335 %R 10.2196/47722 %U https://mental.jmir.org/2023/1/e47722 %U https://doi.org/10.2196/47722 %U http://www.ncbi.nlm.nih.gov/pubmed/37672335 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 6 %N %P e46269 %T Acceptability and Feasibility of a Socially Enhanced, Self-Guided, Positive Emotion Regulation Intervention for Caregivers of Individuals With Dementia: Pilot Intervention Study %A Kwok,Ian %A Lattie,Emily Gardiner %A Yang,Dershung %A Summers,Amanda %A Grote,Veronika %A Cotten,Paul %A Moskowitz,Judith Tedlie %+ Northwestern University, Feinberg School of Medicine, 420 E Superior St, Chicago, IL, 60611, United States, 1 323 364 1160, iankwok@u.northwestern.edu %K dementia %K caregiving %K eHealth %K digital interventions %K positive emotion %K stress %K coping %D 2023 %7 6.9.2023 %9 Original Paper %J JMIR Aging %G English %X Background: The responsibilities of being a primary caregiver for a loved one with dementia can produce significant stress for the caregiver, leading to deleterious outcomes for the caregiver’s physical and psychological health. Hence, researchers are developing eHealth interventions to provide support for caregivers. Members of our research team previously developed and tested a positive emotion regulation intervention that we delivered through videoconferencing, in which caregiver participants would meet one-on-one with a trained facilitator. Although proven effective, such delivery methods have limited scalability because they require significant resources in terms of cost and direct contact hours. Objective: This study aimed to conduct a pilot test of a socially enhanced, self-guided version of the positive emotion regulation intervention, Social Augmentation of Self-Guided Electronic Delivery of the Life Enhancing Activities for Family Caregivers (SAGE LEAF). Studies have shown that social presence or the perception of others in a virtual space is associated with enhanced learning and user satisfaction. Hence, the intervention leverages various social features (eg, discussion boards, podcasts, videos, user profiles, and social notifications) to foster a sense of social presence among participants and study team members. Methods: Usability, usefulness, feasibility, and acceptability data were collected from a pilot test in which participants (N=15) were given full access to the SAGE LEAF intervention over 6 weeks and completed preintervention and postintervention assessments (10/15, 67%). Preliminary outcome measures were also collected, with an understanding that no conclusions about efficacy could be made, because our pilot study did not have a control group and was not sufficiently powered. Results: The results suggest that SAGE LEAF is feasible, with participants viewing an average of 72% (SD 42%) of the total available intervention web pages. In addition, acceptability was found to be good, as demonstrated by participants’ willingness to recommend the SAGE LEAF program to a friend or other caregiver. Applying Pearson correlational analyses, we found moderate, positive correlation between social presence scores and participants’ willingness to recommend the program to others (r9=0.672; P=.03). We also found positive correlation between social presence scores and participants’ perceptions about the overall usefulness of the intervention (r9=0.773; P=.009). This suggests that participants’ sense of social presence may be important for the feasibility and acceptability of the program. Conclusions: In this pilot study, the SAGE LEAF intervention demonstrates potential for broad dissemination for dementia caregivers. We aim to incorporate participant feedback about how the social features may be improved in future iterations to enhance usability and to further bolster a sense of social connection among participants and study staff members. Next steps include partnering with dementia clinics and other caregiver-serving organizations across the United States to conduct a randomized controlled trial to evaluate the effectiveness of the intervention. %M 37672311 %R 10.2196/46269 %U https://aging.jmir.org/2023/1/e46269 %U https://doi.org/10.2196/46269 %U http://www.ncbi.nlm.nih.gov/pubmed/37672311 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 9 %N %P e44320 %T Effects of Web-Based and Mobile Self-Care Support in Addition to Standard Care in Patients After Radical Prostatectomy: Randomized Controlled Trial %A Wennerberg,Camilla %A Hellström,Amanda %A Schildmeijer,Kristina %A Ekstedt,Mirjam %+ Department of Health and Caring Sciences, Linnaeus University, Hus Vita, Kalmar, SE-391 82, Sweden, 46 737822601, camilla.wennerberg@lnu.se %K eHealth %K linear mixed model %K prostatic neoplasms %K radical prostatectomy %K randomized controlled trial %K self-care %K telemedicine %K mobile health %K mHealth %K prostate cancer %K sexual dysfunction %K urinary incontinence %K web-based %K pelvic exercise %K physical activity %D 2023 %7 6.9.2023 %9 Original Paper %J JMIR Cancer %G English %X Background: Prostate cancer is a common form of cancer that is often treated with radical prostatectomy, which can leave patients with urinary incontinence and sexual dysfunction. Self-care (pelvic floor muscle exercises and physical activity) is recommended to reduce the side effects. As more and more men are living in the aftermath of treatment, effective rehabilitation support is warranted. Digital self-care support has the potential to improve patient outcomes, but it has rarely been evaluated longitudinally in randomized controlled trials. Therefore, we developed and evaluated the effects of digital self-care support (electronic Patient Activation in Treatment at Home [ePATH]) on prostate-specific symptoms. Objective: This study aimed to investigate the effects of web-based and mobile self-care support on urinary continence, sexual function, and self-care, compared with standard care, at 1, 3, 6, and 12 months after radical prostatectomy. Methods: A multicenter randomized controlled trial with 2 study arms was conducted, with the longitudinal effects of additional digital self-care support (ePATH) compared with those of standard care alone. ePATH was designed based on the self-determination theory to strengthen patients’ activation in self-care through nurse-assisted individualized modules. Men planned for radical prostatectomy at 3 county hospitals in southern Sweden were included offline and randomly assigned to the intervention or control group. The effects of ePATH were evaluated for 1 year after surgery using self-assessed questionnaires. Linear mixed models and ordinal regression analyses were performed. Results: This study included 170 men (85 in each group) from January 2018 to December 2019. The participants in the intervention and control groups did not differ in their demographic characteristics. In the intervention group, 64% (53/83) of the participants used ePATH, but the use declined over time. The linear mixed model showed no substantial differences between the groups in urinary continence (β=−5.60; P=.09; 95% CI −12.15 to −0.96) or sexual function (β=−.12; P=.97; 95% CI −7.05 to −6.81). Participants in the intervention and control groups did not differ in physical activity (odds ratio 1.16, 95% CI 0.71-1.89; P=.57) or pelvic floor muscle exercises (odds ratio 1.51, 95% CI 0.86-2.66; P=.15). Conclusions: ePATH did not affect postoperative side effects or self-care but reflected how this support may work in typical clinical conditions. To complement standard rehabilitation, digital self-care support must be adapted to the context and individual preferences for use and effect. Trial Registration: ISRCTN Registry ISRCTN18055968; https://www.isrctn.com/ISRCTN18055968 International Registered Report Identifier (IRRID): RR2-10.2196/11625 %M 37672332 %R 10.2196/44320 %U https://cancer.jmir.org/2023/1/e44320 %U https://doi.org/10.2196/44320 %U http://www.ncbi.nlm.nih.gov/pubmed/37672332 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41502 %T Just-In-Time Adaptive Intervention to Sit Less and Move More in People With Type 2 Diabetes: Protocol for a Microrandomized Trial %A Daryabeygi-Khotbehsara,Reza %A Dunstan,David W %A Islam,Sheikh Mohammed Shariful %A Zhang,Yuxin %A Abdelrazek,Mohamed %A Maddison,Ralph %+ Institute for Physical Activity and Nutrition (IPAN), Deakin University, 221 Burwood Hw, Geelong, 3125, Australia, 61 3 924 459362, reza.d@deakin.edu.au %K diabetes %K just-in-time adaptive intervention %K JITAI %K micro-randomized trial %K MRT %K physical activity %K sedentary behavior %D 2023 %7 6.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Reducing sedentary behavior and increasing physical activity in people with type 2 diabetes (T2D) are associated with various positive health benefits. Just-in-time adaptive interventions offer the potential to target both of these behaviors through more contextually aware, tailored, and personalized support. We have developed a just-in-time adaptive intervention to promote sitting less and moving more in people with T2D. Objective: This paper presents the study protocol for a microrandomized trial to investigate whether motivational messages are effective in reducing time spent sitting in people with T2D and to determine what behavior change techniques are effective and in which context (eg, location, etc). Methods: We will use a 6-week microrandomized trial design. A total of 22 adults with T2D will be recruited. The intervention aims to reduce sitting time and increase time spent standing and walking and comprises a mobile app (iMove), a bespoke activity sensor called Sedentary Behavior Detector (SORD), a messaging system, and a secured database. Depending on the randomization sequence, participants will potentially receive motivational messages 5 times a day. Results: Recruitment was initiated in October 2022. As of now, 6 participants (2 female and 4 male) have consented and enrolled in the study. Their baseline measurements have been completed, and they have started using iMove. The mean age of 6 participants is 56.8 years, and they were diagnosed with T2D for 9.4 years on average. Conclusions: This study will inform the optimization of digital behavior change interventions to support people with T2D Sit Less and Move More to increase daily physical activity. This study will generate new evidence about the immediate effectiveness of sedentary behavior interventions, their active ingredients, and associated factors. Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12622000426785; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383664 International Registered Report Identifier (IRRID): DERR1-10.2196/41502 %M 37672323 %R 10.2196/41502 %U https://www.researchprotocols.org/2023/1/e41502 %U https://doi.org/10.2196/41502 %U http://www.ncbi.nlm.nih.gov/pubmed/37672323 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45262 %T Using HIV Risk Self-Assessment Tools to Increase HIV Testing in Men Who Have Sex With Men in Beijing, China: App-Based Randomized Controlled Trial %A Luo,Qianqian %A Wu,Zunyou %A Mi,Guodong %A Xu,Jie %A Scott,Sarah Robbins %+ School of Nursing, Binzhou Medical University, 346 Guanhai Road, Laishan District, Yantai, 264003, China, 86 535 6913180, luoqq@bzmc.edu.cn %K app %K China %K HIV testing %K men who have sex with men %K risk assessment %D 2023 %7 1.9.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Men who have sex with men (MSM) in China hold a low-risk perception of acquiring HIV. This has resulted in an inadequate HIV testing rate. Objective: This study aims to investigate whether administering HIV risk self-assessments with tailored feedback on a gay geosocial networking (GSN) app could improve HIV testing rates and reduce sexual risk behaviors in Chinese MSM. Methods: We recruited MSM from Beijing, China, who used the GSN platform Blued in October 2017 in this 12-month double-blinded randomized controlled trial. From October 2017 to September 2018, eligible participants were randomly assigned to use a self-reported HIV risk assessment tool that provided tailored feedback according to transmission risk (group 1), access to the same HIV risk assessment without feedback (group 2), or government-recommended HIV education materials (control). All interventions were remotely delivered through the mobile phone–based app Blued, and participants were followed up at 1, 3, 6, and 12 months from baseline. The number of HIV tests over the 12-month study was the primary outcome and was assessed using an intention-to-treat analysis with an incident rate ratio (IRR). Unprotected anal intercourse (UAI) over 6 months was assessed by a modified intention-to-treat analysis and was the secondary outcome. All statistical analyses were conducted in SAS 9.3 (SAS Institute, Inc.), and a P value <.05 was considered statistically significant. Results: In total, 9280 MSM were recruited from baseline and were randomly assigned to group 1 (n=3028), group 2 (n=3065), or controls (n=3187). After follow-up, 1034 (34.1%), 993 (32.4%), and 1103 (34.6%) remained in each group, respectively. Over 12 months, group 1 took 391 tests (mean of 2.51 tests per person), group 2 took 352 tests (mean of 2.01 tests per person), and controls took 295 tests (mean of 1.72 tests per person). Group 1 had significantly more HIV testing than the control group (IRR 1.32, 95% CI 1.09-4.58; P=.01), while group 2 did not differ significantly from the controls (IRR 1.06, 95% CI 0.86-1.30; P=.60). The proportion of UAI was not statistically different among different groups, but all 3 groups had UAI, which declined from baseline. Conclusions: Repeated HIV risk assessments coupled with tailored feedback through GSN apps improved HIV testing. Such interventions should be considered a simple way of improving HIV testing among MSM in China and increasing awareness of HIV status. Trial Registration: ClinicalTrials.gov NCT03320239; https://clinicaltrials.gov/study/NCT03320239 %M 37656500 %R 10.2196/45262 %U https://www.jmir.org/2023/1/e45262 %U https://doi.org/10.2196/45262 %U http://www.ncbi.nlm.nih.gov/pubmed/37656500 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46560 %T A Text Messaging Intervention for Priming the Affective Rewards of Exercise in Adults: Protocol for a Microrandomized Trial %A Mishra,Sonali R %A Dempsey,Walter %A Klasnja,Predrag %+ Department of Internal Medicine, University of Michigan, NCRC B100, Ann Arbor, MI, 48109, United States, 1 215 266 0952, srmishra@umich.edu %K mobile health %K mHealth interventions %K physical activity %K affective attitudes %K mobile phone %D 2023 %7 1.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Physical activity is a critical target for health interventions, but effective interventions remain elusive. A growing body of work suggests that interventions targeting affective attitudes toward physical activity may be more effective for sustaining activity long term than those that rely on cognitive constructs alone, such as goal setting and self-monitoring. Anticipated affective response in particular is a promising target for intervention. Objective: We will evaluate the efficacy of an SMS text messaging intervention that manipulates anticipated affective response to exercise to promote physical activity. We hypothesize that reminding users of a positive postexercise affective state before their planned exercise sessions will increase their calories burned during this exercise session. We will deploy 2 forms of affective SMS text messages to explore the design space: low-reflection messages written by participants for themselves and high-reflection prompts that require users to reflect and respond. We will also explore the effect of the intervention on affective attitudes toward exercise. Methods: A total of 120 individuals will be enrolled in a 9-week microrandomized trial testing affective messages that remind users about feeling good after exercise (40% probability), control reminders (30% probability), or no message (30% probability). Two types of affective SMS text messages will be deployed: one requiring a response and the other in a read-only format. Participants will write the read-only messages themselves to ensure that the messages accurately reflect the participants’ anticipated postexercise affective state. Affective attitudes toward exercise and intrinsic motivation for exercise will be measured at the beginning and end of the study. The weighted and centered least squares method will be used to analyze the effect of delivering the intervention versus not on calories burned over 4 hours around the time of the planned activity, measured by the Apple Watch. Secondary analyses will include the effect of the intervention on step count and active minutes, as well as an investigation of the effects of the intervention on affective attitudes toward exercise and intrinsic motivation for exercise. Participants will be interviewed to gain qualitative insights into intervention impact and acceptability. Results: Enrollment began in May 2023, with 57 participants enrolled at the end of July 2023. We anticipate enrolling 120 participants. Conclusions: This study will provide early evidence about the effect of a repeated manipulation of anticipated affective response to exercise. The use of 2 different types of messages will yield insight into optimal design strategies for improving affective attitudes toward exercise. Trial Registration: ClinicalTrials.gov NCT05582369; https://classic.clinicaltrials.gov/ct2/show/NCT05582369 International Registered Report Identifier (IRRID): PRR1-10.2196/46560 %M 37656493 %R 10.2196/46560 %U https://www.researchprotocols.org/2023/1/e46560 %U https://doi.org/10.2196/46560 %U http://www.ncbi.nlm.nih.gov/pubmed/37656493 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 9 %N %P e44612 %T Advanced Messaging Intervention for Medication Adherence and Clinical Outcomes Among Patients With Cancer: Randomized Controlled Trial %A Ni,Chen-Xu %A Lu,Wen-Jie %A Ni,Min %A Huang,Fang %A Li,Dong-Jie %A Shen,Fu-Ming %+ Department of Pharmacy, Shanghai Tenth People’s Hospital, Tongji University School of Medicine, 301 Middle Yanchang Road, Shanghai, 200072, China, 86 66302570, fumingshen@tongji.edu.cn %K 5G messaging %K fifth-generation %K medication adherence %K patients with cancer %K clinical pharmacists %K randomized controlled trial %D 2023 %7 31.8.2023 %9 Original Paper %J JMIR Cancer %G English %X Background: Medication adherence is crucial for improving clinical outcomes in the treatment of patients with cancer. The lack of adherence and adverse drug reactions can reduce the effectiveness of cancer therapy including the quality of life. The commonly used intervention methods for medication adherence continue to evolve, and the age of fifth-generation (5G) messaging has arrived. Objective: In this study, we conducted a prospective, pilot randomized controlled trial to evaluate the effect of 5G messaging on medication adherence and clinical outcomes among patients with cancer in China. Methods: The research population was patients with nonsmall cell lung cancer undergoing pemetrexed chemotherapy who require regular folic acid (FA) and vitamin B12 supplements. The intervention and control groups were assigned to 5G messaging and second-generation (2G) messaging, respectively. The patients’ medication adherence and quality of life were assessed at baseline and 1-month and 3-month time points. Moreover, the chemotherapy-related hematologic or nonhematologic toxicities, as well as the serum levels of FA and vitamin B12, were measured. Results: Of the 567 patients assessed for eligibility between January and May 2021, a total of 154 (27.2%) patients were included. Overall, 80 were randomized to the control group and 74 to the intervention group. The odds of adherence in the 5G messaging intervention group were significantly higher than the control group at the 1-month (62/69, 90% vs 56/74, 76%; adjusted odds ratio 2.67, 95% CI 1.02-7.71) and 3-month (50/60, 83% vs 48/64, 75%; adjusted odds ratio 2.36, 95% CI 1.00-5.23) time points. Correspondingly, the FA and vitamin B12 serum levels of patients in the 5G messaging group were higher than those of the control group. Regarding hematologic toxicities, only the incidence of leukopenia in the intervention group was lower than that in the control group (25/80, 31% in the control group vs 12/74, 16% in the intervention group; P=.04). There were no differences in nonhematologic toxicities and quality of life between the 2 groups. Conclusions: In summary, we conclude that compared with conventional 2G text-based messaging, a 5G messaging intervention can better improve medication adherence and clinical outcome among patients with cancer. Trial Registration: Chinese Clinical Trial Registry ChiCTR2200058188; https://www.chictr.org.cn/showproj.html?proj=164489 %M 37651170 %R 10.2196/44612 %U https://cancer.jmir.org/2023/1/e44612 %U https://doi.org/10.2196/44612 %U http://www.ncbi.nlm.nih.gov/pubmed/37651170 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e49806 %T Mobile Technology to Monitor and Support Health and Well-Being: Qualitative Study of Perspectives and Design Suggestions From Patients Undergoing Hematopoietic Cell Transplantation %A Caparso,Cinzia %A Ozkan,Gwynne %A Kluge,Maxwell %A Salim,Humza %A Khaghany,Aidan %A Blok,Amanda %A Choi,Sung Won %+ Department of Systems, Populations and Leadership Center for Improving Patient and Population Health, University of Michigan School of Nursing, 426 N Ingalls St., Ann Arbor, MI, 48014, United States, 1 586 219 1449, ccaparso@umich.edu %K hematopoietic stem cell transplantation %K bone marrow %K surgery %K surgical %K recovery %K mobile apps %K mHealth %K mobile health %K app %K apps %K qualitative research %K qualitative %K experience %K experiences %K perception %K perceptions %K stem cell %K stem cells %K transplant %K transplantation %K transplants %K hematopoietic %K positive psychology %K psychology %D 2023 %7 31.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: In the United States, hematopoietic stem cell transplant (HCT) surpasses 22,000 procedures annually. Due to the demanding and time-intensive process of an HCT, patients and family care partners face unique challenges involving their health and well-being. Positive psychology interventions (PPIs) may offer potential solutions to help boost health and well-being. Objective: This study aimed to explore and understand patients’ experiences and perceptions about the use of the Roadmap 2.0 app, specifically its PPI features, during the acute phase of HCT. Methods: From an ongoing randomized controlled trial, HCT patients (n=17) were recruited to participate in semistructured qualitative interviews between October 2022 and January 2023 within a large academic medical center in the Midwestern states. Using a qualitative descriptive approach, interviews were conducted in person or via Zoom. The data were analyzed through constant comparative analysis. The Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines were followed. Results: The majority of the participants reported Roadmap 2.0 as easy to use and enjoyed the ability to track their health data (eg, steps, mood, sleep; 9/17). Regarding the use of PPIs during the acute phase of treatment, 88% of the participants reported interest in participating in PPIs, specifically the Pleasant Activity Scheduling (11/17) followed by Gratitude Journaling (7/17) activities. Additionally, participants provided recommendations on adapting Roadmap 2.0. The major recommendations were (1) “Working Together: Need for Dyadic Involvement,” (2) “Connectivity with Other Patients,” and (3) “Gap in Nutritional Support.” Participants (10/17) expressed the importance of caregiver involvement in activities beyond treatment-related management for maintaining healthy patient-caregiver dyadic relationships. They also expressed their desire for connectivity with other patients undergoing HCT, primarily for comparing experiences and discussing topics such as symptom management (8/17). Lastly, participants identified a gap in nutritional support during the HCT process and expressed interest in an intervention that could promote healthy eating through education and notification reminders (9/17). Conclusions: Participants openly expressed their eagerness to participate in research studies that foster connection and positive relationships with their caregivers as well as with other HCT patients. They emphasized the significance of having access to nutritional support or guidance and highlighted the potential benefits of using mobile technology to enhance these collective efforts. Trial Registration: ClinicalTrials.gov NCT04094844; https://clinicaltrials.gov/study/NCT04094844 International Registered Report Identifier (IRRID): RR2-10.2196/19288 %M 37651172 %R 10.2196/49806 %U https://formative.jmir.org/2023/1/e49806 %U https://doi.org/10.2196/49806 %U http://www.ncbi.nlm.nih.gov/pubmed/37651172 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47126 %T Culturally Adapting an Internet-Delivered Mindfulness Intervention for Indonesian University Students Experiencing Psychological Distress: Mixed Methods Study %A Listiyandini,Ratih Arruum %A Andriani,Annisa %A Kusristanti,Chandradewi %A Moulds,Michelle %A Mahoney,Alison %A Newby,Jill M %+ School of Psychology, Faculty of Science, University of New South Wales, Mathews Building, Entry Via Gate 11 Botany Street, Sydney, 2052, Australia, 61 2 9385 3041, r.listiyandini@unsw.edu.au %K psychological distress %K mindfulness %K cultural adaptation %K internet-delivered %K students %K Indonesia %K mobile phone %D 2023 %7 31.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Psychological distress is prevalent among university students. However, the availability of evidence-based mental health treatment remains limited in many low- and middle-income countries, including Indonesia. Internet-delivered, mindfulness-based interventions that reduce distress have potential for treating university student distress at scale. Unfortunately, evidence-based, internet-delivered mindfulness treatments are not yet available in Indonesia. Cultural adaptation of established evidence-based, internet-delivered mindfulness interventions is needed. Objective: In this paper, we describe the process of culturally adapting an Australian internet-delivered mindfulness program (Introduction to Mindfulness) to be relevant and appropriate for treating Indonesian university students’ psychological distress. Methods: To assist the cultural adaptation process, we used a systematic cultural adaptation framework and a mixed methods approach combining quantitative and qualitative methods. In study 1 (information gathering), we administered an internet-delivered questionnaire to Indonesian university students (n=248) to examine their preferences regarding an internet-delivered mindfulness intervention. In study 2 (preliminary design), a draft program was developed and independently reviewed by Indonesian stakeholders. Stakeholders (n=25) included local Indonesian mindfulness and mental health professionals (n=6) and university students (n=19), who were selected to maximize sample representativeness regarding personal and professional characteristics. To evaluate the initial design and cultural congruence of the internet-delivered mindfulness program in the Indonesian context, we conducted interviews and focus groups with stakeholders. Stakeholders also completed the Cultural Relevance Questionnaire. Results: In study 1, most Indonesian university students (240/248, 96.8%) reported openness to an internet-delivered mindfulness program. Most of interested students (127/240, 52.9%) preferred the length of the program to be 3 to 4 sessions, with 45.8% (110/240) preferring brief lessons taking only 15 to 30 minutes to complete. They (194/240, 80.8%) recommended that the program be accessible both through websites and mobile phones. In study 2, Indonesian stakeholders generally found the internet-delivered program to be highly culturally appropriate in terms of language, concepts, context, treatment goals, and depictions of students’ emotional and behavioral experiences. However, stakeholders also recommended some specific adaptations regarding the program’s delivery model (eg, combining visual and audio modalities when delivering psychoeducation), cultural components (eg, including more social and spiritual activities), program practicality (eg, including rewards to promote engagement), and design elements (eg, including additional culturally relevant illustrations). Following stakeholder feedback, a new culturally adapted Indonesian internet-delivered mindfulness program called Program Intervensi Mindfulness Daring Mahasiswa Indonesia was created. Conclusions: This study highlights the process and importance of cultural adaptation of an evidence-based mindfulness treatment and demonstrates how this may be achieved for internet-delivered psychotherapy programs. We found that a culturally adapted internet-delivered mindfulness program was relevant for Indonesian students with some adjustments to the programs’ content and delivery. Future research is now needed to evaluate the clinical benefit of this program. %M 37651168 %R 10.2196/47126 %U https://formative.jmir.org/2023/1/e47126 %U https://doi.org/10.2196/47126 %U http://www.ncbi.nlm.nih.gov/pubmed/37651168 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49032 %T Identifying the Characteristics of Responders and Nonresponders in a Behavioral Intervention to Increase Physical Activity Among Patients With Moderate to Severe Asthma: Protocol for a Prospective Pragmatic Study %A de Lima,Fabiano Francisco %A Lunardi,Adriana Claudia %A Pinheiro,David Halen Araújo %A Carvalho-Pinto,Regina Maria %A Stelmach,Rafael %A Giavina‑Bianchi,Pedro %A Agondi,Rosana Câmara %A Carvalho,Celso RF %+ Department of Physical Therapy, School of Medicine, University of São Paulo, Av. Dr Arnaldo 455 – Room 1210, São Paulo, 01246-903, Brazil, 55 11 984153234, cscarval@usp.br %K asthma %K behavioral intervention %K physical activity %K responders %D 2023 %7 31.8.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Previous research has suggested that most adults improve their asthma control after a short-term behavioral intervention program to increase physical activity in daily life (PADL). However, the characteristics of individuals who respond and do not respond to this intervention and the medium-term response remain unknown. Objective: This study aims to (1) identify the characteristics of adult responders and nonresponders with asthma to a behavioral intervention to increase physical activity and (2) evaluate the functional and clinical benefits in the medium term. Methods: This prospective pragmatic study will include adults with moderate to severe asthma who enroll in a behavioral intervention. All individuals will receive an educational program and an 8-week intervention to increase PADL (1 time/wk; up to 90 min/session). The educational program will be conducted in a class setting through group discussions and video presentations. Behavioral interventions will be based on the transtheoretical model using counseling, incentives, and individual feedback aiming to increase participation in physical activity. Motivational interviewing and guidelines for overcoming barriers will be used to stimulate individuals to reach their goals. Pre- and postintervention assessments will include the following: PADL (triaxial accelerometry), body composition (octopolar bioimpedance), barriers to PADL (questionnaire), clinical asthma control (Asthma Control Questionnaire), quality of life (Asthma Quality of Life Questionnaire), anxiety and depression levels (Hospital Anxiety and Depression Scale), and exacerbations. “Responders” to the intervention will be defined as those who demonstrate an increase in the number of daily steps (≥2500). Results: In December 2021, the clinical trial registration was approved. Recruitment and data collection for the trial is ongoing, and the results of this study are likely to be published in late 2024. Conclusions: The intervention will likely promote different effects according to the clinical characteristics of the individuals, including asthma control, age, anxiety and depression levels, obesity, and several comorbidities. Identifying individuals who respond or do not respond to behavioral interventions to increase PADL will help clinicians prescribe specific interventions to adults with asthma. Trial Registration: ClinicalTrials.gov NCT05159076; https://clinicaltrials.gov/ct2/show/NCT05159076 International Registered Report Identifier (IRRID): DERR1-10.2196/49032 %M 37651174 %R 10.2196/49032 %U https://www.researchprotocols.org/2023/1/e49032 %U https://doi.org/10.2196/49032 %U http://www.ncbi.nlm.nih.gov/pubmed/37651174 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e47260 %T Artificial Intelligence–Based Consumer Health Informatics Application: Scoping Review %A Asan,Onur %A Choi,Euiji %A Wang,Xiaomei %+ School of Systems and Enterprises, Stevens Institute of Technology, 1 Castle Point Terrace, Hoboken, NJ, 07030, United States, 1 4145264330, oasan@stevens.edu %K consumer informatics %K artificial intelligence %K mobile health %K mHealth %K patient outcomes %K personalized health care %K machine learning %K digital health %K mobile phone %D 2023 %7 30.8.2023 %9 Review %J J Med Internet Res %G English %X Background: There is no doubt that the recent surge in artificial intelligence (AI) research will change the trajectory of next-generation health care, making it more approachable and accessible to patients. Therefore, it is critical to research patient perceptions and outcomes because this trend will allow patients to be the primary consumers of health technology and decision makers for their own health. Objective: This study aimed to review and analyze papers on AI-based consumer health informatics (CHI) for successful future patient-centered care. Methods: We searched for all peer-reviewed papers in PubMed published in English before July 2022. Research on an AI-based CHI tool or system that reports patient outcomes or perceptions was identified for the scoping review. Results: We identified 20 papers that met our inclusion criteria. The eligible studies were summarized and discussed with respect to the role of the AI-based CHI system, patient outcomes, and patient perceptions. The AI-based CHI systems identified included systems in mobile health (13/20, 65%), robotics (5/20, 25%), and telemedicine (2/20, 10%). All the systems aimed to provide patients with personalized health care. Patient outcomes and perceptions across various clinical disciplines were discussed, demonstrating the potential of an AI-based CHI system to benefit patients. Conclusions: This scoping review showed the trend in AI-based CHI systems and their impact on patient outcomes as well as patients’ perceptions of these systems. Future studies should also explore how clinicians and health care professionals perceive these consumer-based systems and integrate them into the overall workflow. %M 37647122 %R 10.2196/47260 %U https://www.jmir.org/2023/1/e47260 %U https://doi.org/10.2196/47260 %U http://www.ncbi.nlm.nih.gov/pubmed/37647122 %0 Journal Article %@ 2563-3570 %I JMIR Publications %V 4 %N %P e45370 %T User and Usability Testing of a Web-Based Genetics Education Tool for Parkinson Disease: Mixed Methods Study %A Han,Noah %A Paul,Rachel A %A Bardakjian,Tanya %A Kargilis,Daniel %A Bradbury,Angela R %A Chen-Plotkin,Alice %A Tropea,Thomas F %+ Department of Neurology, Perelman School of Medicine, University of Pennsylvania, 330 South 9th Street, Philadelphia, PA, 19107, United States, 1 215 829 7731, Thomas.Tropea@pennmedicine.upenn.edu %K Parkinson disease %K genetic testing %K teleneurology %K patient education %K neurology %K genetic %K usability %K user testing %K web-based %K internet-based %K web-based resource %K mobile phone %D 2023 %7 30.8.2023 %9 Original Paper %J JMIR Bioinform Biotech %G English %X Background: Genetic testing is essential to identify research participants for clinical trials enrolling people with Parkinson disease (PD) carrying a variant in the glucocerebrosidase (GBA) or leucine-rich repeat kinase 2 (LRRK2) genes. The limited availability of professionals trained in neurogenetics or genetic counseling is a major barrier to increased testing. Telehealth solutions to increase access to genetics education can help address issues around counselor availability and offer options to patients and family members. Objective: As an alternative to pretest genetic counseling, we developed a web-based genetics education tool focused on GBA and LRRK2 testing for PD called the Interactive Multimedia Approach to Genetic Counseling to Inform and Educate in Parkinson’s Disease (IMAGINE-PD) and conducted user testing and usability testing. The objective was to conduct user and usability testing to obtain stakeholder feedback to improve IMAGINE-PD. Methods: Genetic counselors and PD and neurogenetics subject matter experts developed content for IMAGINE-PD specifically focused on GBA and LRRK2 genetic testing. Structured interviews were conducted with 11 movement disorder specialists and 13 patients with PD to evaluate the content of IMAGINE-PD in user testing and with 12 patients with PD to evaluate the usability of a high-fidelity prototype according to the US Department of Health and Human Services Research-Based Web Design & Usability Guidelines. Qualitative data analysis informed changes to create a final version of IMAGINE-PD. Results: Qualitative data were reviewed by 3 evaluators. Themes were identified from feedback data of movement disorder specialists and patients with PD in user testing in 3 areas: content such as the topics covered, function such as website navigation, and appearance such as pictures and colors. Similarly, qualitative analysis of usability testing feedback identified additional themes in these 3 areas. Key points of feedback were determined by consensus among reviewers considering the importance of the comment and the frequency of similar comments. Refinements were made to IMAGINE-PD based on consensus recommendations by evaluators within each theme at both user testing and usability testing phases to create a final version of IMAGINE-PD. Conclusions: User testing for content review and usability testing have informed refinements to IMAGINE-PD to develop this focused, genetics education tool for GBA and LRRK2 testing. Comparison of this stakeholder-informed intervention to standard telegenetic counseling approaches is ongoing. %R 10.2196/45370 %U https://bioinform.jmir.org/2023/1/e45370 %U https://doi.org/10.2196/45370 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e42101 %T Usefulness of Self-Assessment of Gastrointestinal Symptoms: Web-Based Study in Anhui, China %A Guan,Xiaoqin %A Xue,Qun %A Ma,Huan %A Li,Guocheng %A Xu,Xiuze %A Zhang,Kexin %A Tang,Mengsha %A Liu,Rong %A Wang,Debin %A Shen,Xingrong %+ School of Health Service Management, Anhui Medical University, 81 Meishan Road, Shushan District, Hefei, Anhui, 230032, China, 86 13505612172, xinrongshen@sina.com %K gastrointestinal symptoms %K health care seeking %K symptoms reporting %K web-based self-assessment %K China %D 2023 %7 30.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Gastrointestinal symptoms (GISs) are caused by a combination of biopsychosocial factors and are highly prevalent worldwide. Given their complex nature, coupled with ineffective communication of diagnoses by physicians, patients with intimate GISs often feel stigmatized. This, in turn, can inhibit their ability to express their thoughts and feelings adequately, leading them to over- or underreport their symptoms. Moreover, selective service-seeking for and reporting of GISs have a direct bearing on the stage of disease at presentation and, consequently, on the overall prognosis. Objective: This study aimed to investigate the usefulness of a web-based self-assessment of GISs as a supplementary means to cope with potential over- or underreporting during routine consultations. Methods: GIS data were collected using a novel web-based self-assessment tool (n=475) and from nonparticipative observation of doctor-patient consultations (n=447) and household surveys (n=10,552) in Anhui, China. Data analysis focused primarily on the description of the composition of respondents and the occurrence rates of GISs by sociodemographics, and by symptom solicitation methods and settings. Chi-square power tests were used when necessary to compare differences in the occurrence rates between relevant groups. The level of significance for the 2-sided test was set at α<.05. Results: The average occurrence rates of both upper and lower GISs derived from the web-based self-assessment were higher than those from the observation (upper GISs: n=661, 20.9% vs n=382, 14.2%; P<.001; lower GISs: n=342, 12.9% vs n=250, 10.8%; P=.02). The differences in 6 of the 9 upper GISs and 3 of the 11 lower GISs studied were tested with statistical significance (P<.05); moreover, a higher frequency rate was recorded for symptoms with statistical significance via self-assessment than via observation. For upper GISs, the self-assessed versus observed differences ranged from 17.1% for bloating to 100% for bad mood after a meal, while for lower GISs, the differences ranged from −50.5% for hematochezia or melena to 100% for uncontrollable stool. Stomachache, regurgitation, and dysphagia had higher occurrence rates among participants of the self-assessment group than those of the household survey group (20% vs 12.7%, 14% vs 11%, and 3% vs 2.3%, respectively), while the opposite was observed for constipation (5% vs 10.9%), hematochezia or melena (4% vs 5%), and anorexia (4% vs 5.2%). All differences noted in the self-assessed occurrence rates of specific, persistent GISs between sociodemographic groups were tested for nonsignificance (P>.05), while the occurrence rates of any of the 6 persistent GISs among respondents aged 51-60 years was statistically higher than that among other age groups (P=.03). Conclusions: The web-based self-assessment tool piloted in this study is useful and acceptable for soliciting more comprehensive GISs, especially symptoms with concerns about stigmatization, privacy, and shame. Further studies are needed to integrate the web-based self-assessment with routine consultations and to evaluate its efficacy. %M 37583117 %R 10.2196/42101 %U https://formative.jmir.org/2023/1/e42101 %U https://doi.org/10.2196/42101 %U http://www.ncbi.nlm.nih.gov/pubmed/37583117 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49364 %T Evaluating the Effectiveness of a Codeveloped e-Mental Health Intervention for University Students: Protocol for a Randomized Controlled Trial %A Wang,Angel Y %A Vereschagin,Melissa %A Richardson,Chris G %A Xie,Hui %A Hudec,Kristen L %A Munthali,Richard J %A Munro,Lonna %A Leung,Calista %A Kessler,Ronald C %A Vigo,Daniel V %+ Department of Psychiatry, Faculty of Medicine, University of British Columbia, 2255 Wesbrook Mall, Vancouver, BC, V6T2A1, Canada, 1 6048228048, daniel.vigo@ubc.ca %K mental health %K substance use %K college students %K digital interventions %K randomized controlled trial %K mobile phone %D 2023 %7 30.8.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: University life typically occurs during a period of life transition, where the incidence of mental health and substance use problems and disorders peaks. However, relatively few students obtain effective treatment and support. e-Interventions have proven effective in improving the psychological outcomes of university students and have the potential to provide scalable services that can easily integrate into existing models of care. Minder is a mobile app codeveloped with university students that offers users a collection of evidence-based interventions tailored to help university students maintain their mental health and well-being and manage their substance use. Objective: This paper describes the protocol for a randomized controlled trial (RCT) that aims to assess the effectiveness of the Minder app in improving the mental health and substance use outcomes of university students. Methods: This study is a 2-arm, parallel assignment, single-blinded, 30-day RCT with 1 intervention group and 1 waitlist control group. Overall, 1496 (748 per trial arm) university students from the University of British Columbia Vancouver Campus (N=54,000) who are aged ≥17 years, have a smartphone with Wi-Fi or cellular data, and speak English will be recruited via a variety of web-based and offline strategies. Participants will be randomized into the intervention or control group after completing a baseline survey. Those randomized into the intervention group will gain immediate access to the Minder app and will be assessed at 2 weeks and 30 days. Those randomized into the control group will be given access to the app content after their follow-up assessment at 30 days. The primary outcomes are measured from baseline to follow-up at 30 days and include changes in general anxiety symptomology, depressive symptomology, and alcohol consumption risk measured by the General Anxiety Disorder 7-Item scale, Patient Health Questionnaire 9-Item scale, and US Alcohol Use Disorders Identification Test-Consumption Scale, respectively. Secondary outcomes include measures related to changes in the frequency of substance use, mental well-being, self-efficacy in managing mental health and substance use, readiness to change, and self-reported use of mental health services and supports (including referral) from baseline to follow-up at 30 days. Results: Trial recruitment and data collection began in September 2022, and the completion of data collection for the trial is anticipated by June 2023. As of May 10, 2023, a total of 1425 participants have been enrolled. Conclusions: The RCT described in this protocol paper will assess whether the Minder app is effective in improving the mental health and substance use outcomes of a general population of Canadian university students. Additional secondary outcome research aims to explore additional outcomes of interest for further research and better understand how to support students’ general mental well-being. Trial Registration: ClinicalTrials.gov NCT05606601; https://clinicaltrials.gov/ct2/show/NCT05606601 International Registered Report Identifier (IRRID): DERR1-10.2196/49364 %M 37647105 %R 10.2196/49364 %U https://www.researchprotocols.org/2023/1/e49364 %U https://doi.org/10.2196/49364 %U http://www.ncbi.nlm.nih.gov/pubmed/37647105 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44955 %T An Evaluation of a Personalized Multicomponent Commercial Digital Weight Management Program: Single-Arm Behavioral Trial %A Pagoto,Sherry %A Xu,Ran %A Bullard,Tiffany %A Foster,Gary D %A Bannor,Richard %A Arcangel,Kaylei %A DiVito,Joseph %A Schroeder,Matthew %A Cardel,Michelle I %+ Department of Allied Health Sciences, University of Connecticut, 358 Mansfield Rd, Unit 1101, Storrs, CT, 06269-1101, United States, 1 617 877 0923, sherry.pagoto@uconn.edu %K weight loss %K digital behavioral weight management program %K single-arm behavioral trial %K personalized weight loss program %K ZeroPoint foods %K weight management %K digital intervention %K diet management %K exercise %D 2023 %7 29.8.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital behavioral weight loss programs are scalable and effective, and they provide an opportunity to personalize intervention components. However, more research is needed to test the acceptability and efficacy of personalized digital behavioral weight loss interventions. Objective: In a 6-month single-arm trial, we examined weight loss, acceptability, and secondary outcomes of a digital commercial weight loss program (WeightWatchers). This digital program included a personalized weight loss program based on sex, age, height, weight, and personal food preferences, as well as synchronous (eg, virtual workshops and individual weekly check-ins) and asynchronous (eg, mobile app and virtual group) elements. In addition to a personalized daily and weekly PersonalPoints target, the program provided users with personalized lists of ≥300 ZeroPoint foods, which are foods that do not need to be weighed, measured, or tracked. Methods: We conducted a pre-post evaluation of this 6-month, digitally delivered, and personalized WeightWatchers weight management program on weight loss at 3 and 6 months in adults with overweight and obesity. The secondary outcomes included participation, satisfaction, fruit and vegetable intake, physical activity, sleep quality, hunger, food cravings, quality of life, self-compassion, well-being, and behavioral automaticity. Results: Of the 153 participants, 107 (69.9%) were female, and 65 (42.5%) identified as being from a minoritized racial or ethnic group. Participants’ mean age was 41.09 (SD 13.78) years, and their mean BMI was 31.8 (SD 5.0) kg/m2. Participants had an average weight change of −4.25% (SD 3.93%) from baseline to 3 months and −5.05% (SD 5.59%) from baseline to 6 months. At 6 months, the percentages of participants who experienced ≥3%, ≥5%, and ≥10% weight loss were 63.4% (97/153), 51% (78/153), and 14.4% (22/153), respectively. The mean percentage of weeks in which participants engaged in ≥1 aspects of the program was 87.53% (SD 23.40%) at 3 months and 77.67% (SD 28.69%) at 6 months. Retention was high (132/153, 86.3%), and more than two-thirds (94/140, 67.1%) of the participants reported that the program helped them lose weight. Significant improvements were observed in fruit and vegetable intake, physical activity, sleep quality, hunger, food cravings, quality of life, and well-being (all P values <.01). Conclusions: This personalized, digital, and scalable behavioral weight management program resulted in clinically significant weight loss in half (78/153, 51%) of the participants as well as improvements in behavioral and psychosocial outcomes. Future research should compare personalized digital weight loss programs with generic programs on weight loss, participation, and acceptability. %M 37642986 %R 10.2196/44955 %U https://www.jmir.org/2023/1/e44955 %U https://doi.org/10.2196/44955 %U http://www.ncbi.nlm.nih.gov/pubmed/37642986 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44000 %T Effects of Web-Based Mindfulness-Based Interventions on Anxiety, Depression, and Stress Among Frontline Health Care Workers During the COVID-19 Pandemic: Systematic Review and Meta-Analysis %A Yang,Jia-ming %A Ye,Hua %A Long,Yi %A Zhu,Qiang %A Huang,Hui %A Zhong,Yan-biao %A Luo,Yun %A Yang,Lei %A Wang,Mao-yuan %+ Department of Rehabilitation Medicine, First Affiliated Hospital of Gannan Medical University, 128 Jinling Road, Zhanggong District, Ganzhou City, Jiangxi Province, Ganzhou, 341000, China, 86 13767766152, wmy.gmu.kf@gmail.com %K web-based %K mindfulness-based intervention %K COVID-19 %K health care worker %K mental disorder %D 2023 %7 29.8.2023 %9 Review %J J Med Internet Res %G English %X Background: Since 2019, the COVID-19 outbreak has spread around the world, and health care workers, as frontline workers, have faced tremendous psychological stress. Objective: The purpose of this study is to explore whether web-based mindfulness-based interventions continue to have a positive impact on anxiety, depression, and stress among health care workers during the COVID-19 pandemic. Methods: The inclusion criteria were as follows: (1) participants were frontline health care workers during the COVID-19 pandemic; (2) the experimental group was a web-based mindfulness-based intervention; (3) the control group used either general psychological intervention or no intervention; (4) outcome indicators included scales to assess anxiety, depression, and stress; and (5) the study type was a randomized controlled study. Studies that did not meet the above requirements were excluded. We searched 9 databases, including Web of Science, Embase, PubMed, Cochrane Library, Scopus, ScienceDirect, SinoMed, China National Knowledge Infrastructure (CNKI), and Wanfang Database, for randomized controlled studies on the effects of web-based mindfulness-based interventions on common mental disorder symptoms among health care workers from January 1, 2020, to October 20, 2022. The methodological quality of the included studies was assessed using the Physiotherapy Evidence Database scale. The Cochrane risk of bias tool was used to assess the risk of bias. Subgroup analysis was used to look for sources of heterogeneity and to explore whether the results were the same for subgroups under different conditions. Sensitivity analysis was used to verify the stability of the pooled results. Results: A total of 10 randomized controlled studies with 1311 participants were included. The results showed that web-based mindfulness-based interventions were effective in reducing the symptoms of anxiety (standard mean difference [SMD]=–0.63, 95% CI –0.96 to –0.31, P<.001, I2=87%), depression (SMD=–0.52, 95% CI –0.77 to –0.26, P<.001, I2=75%), and stress (SMD=–0.20, 95% CI –0.35 to –0.05, P=.01, I2=58%) among health care workers during the COVID-19 pandemic, but with wide CIs and high heterogeneity. Conclusions: Web-based mindfulness-based interventions may be effective in reducing the symptoms of anxiety, depression, and stress among frontline health care workers during the COVID-19 pandemic. However, this effect is relatively mild and needs to be further explored by better studies in the future. Trial Registration: PROSPERO CRD42022343727; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=343727 %M 37527546 %R 10.2196/44000 %U https://www.jmir.org/2023/1/e44000 %U https://doi.org/10.2196/44000 %U http://www.ncbi.nlm.nih.gov/pubmed/37527546 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e42415 %T Stress Management Apps: Systematic Search and Multidimensional Assessment of Quality and Characteristics %A Paganini,Sarah %A Meier,Evelyn %A Terhorst,Yannik %A Wurst,Ramona %A Hohberg,Vivien %A Schultchen,Dana %A Strahler,Jana %A Wursthorn,Max %A Baumeister,Harald %A Messner,Eva-Maria %+ Department of Sport Psychology, Institute of Sports and Sport Science, University of Freiburg, Sandfangweg 4, Freiburg, 79102, Germany, 49 76120345, sarah.paganini@sport.uni-freiburg.de %K stress management %K mobile app %K mHealth %K mobile health %K quality assessment %K review %K evidence base %K availability %D 2023 %7 29.8.2023 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Chronic stress poses risks for physical and mental well-being. Stress management interventions have been shown to be effective, and stress management apps (SMAs) might help to transfer strategies into everyday life. Objective: This review aims to provide a comprehensive overview of the quality and characteristics of SMAs to give potential users or health professionals a guideline when searching for SMAs in common app stores. Methods: SMAs were identified with a systematic search in the European Google Play Store and Apple App Store. SMAs were screened and checked according to the inclusion criteria. General characteristics and quality were assessed by 2 independent raters using the German Mobile Application Rating Scale (MARS-G). The MARS-G assesses quality (range 1 to 5) on the following four dimensions: (1) engagement, (2) functionality, (3) esthetics, and (4) information. In addition, the theory-based stress management strategies, evidence base, long-term availability, and common characteristics of the 5 top-rated SMAs were assessed and derived. Results: Of 2044 identified apps, 121 SMAs were included. Frequently implemented strategies (also in the 5 top-rated SMAs) were psychoeducation, breathing, and mindfulness, as well as the use of monitoring and reminder functions. Of the 121 SMAs, 111 (91.7%) provided a privacy policy, but only 44 (36.4%) required an active confirmation of informed consent. Data sharing with third parties was disclosed in only 14.0% (17/121) of the SMAs. The average quality of the included apps was above the cutoff score of 3.5 (mean 3.59, SD 0.50). The MARS-G dimensions yielded values above this cutoff score (functionality: mean 4.14, SD 0.47; esthetics: mean 3.76, SD 0.73) and below this score (information: mean 3.42, SD 0.46; engagement: mean 3.05, SD 0.78). Most theory-based stress management strategies were regenerative stress management strategies. The evidence base for 9.1% (11/121) of the SMAs could be identified, indicating significant group differences in several variables (eg, stress or depressive symptoms) in favor of SMAs. Moreover, 38.0% (46/121) of the SMAs were no longer available after a 2-year period. Conclusions: The moderate information quality, scarce evidence base, constraints in data privacy and security features, and high volatility of SMAs pose challenges for users, health professionals, and researchers. However, owing to the scalability of SMAs and the few but promising results regarding their effectiveness, they have a high potential to reach and help a broad audience. For a holistic stress management approach, SMAs could benefit from a broader repertoire of strategies, such as more instrumental and mental stress management strategies. The common characteristics of SMAs with top-rated quality can be used as guidance for potential users and health professionals, but owing to the high volatility of SMAs, enhanced evaluation frameworks are needed. %M 37642999 %R 10.2196/42415 %U https://mhealth.jmir.org/2023/1/e42415 %U https://doi.org/10.2196/42415 %U http://www.ncbi.nlm.nih.gov/pubmed/37642999 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45004 %T Adapting the Diabetes Prevention Program for Older Adults: Descriptive Study %A Beasley,Jeannette M %A Johnston,Emily A %A Costea,Denisa %A Sevick,Mary Ann %A Rogers,Erin S %A Jay,Melanie %A Zhong,Judy %A Chodosh,Joshua %+ Department of Nutrition and Food Studies, New York University Steinhardt School of School of Culture, Education, and Human Development, 411 Lafayette Street, 526, New York, NY, 10003, United States, 1 2129985782, jbeasley@nyu.edu %K aging %K diabetes prevention program %K nutrition %K diet %K physical activity %K weight loss %K weight %K exercise %K diabetes %K prevention %K diabetic %K ageing %K older adult %K online intervention %K digital intervention %K virtual delivery %K lifestyle coach %K group-based intervention %D 2023 %7 29.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Prediabetes affects 26.4 million people aged 65 years or older (48.8%) in the United States. Although older adults respond well to the evidence-based Diabetes Prevention Program, they are a heterogeneous group with differing physiological, biomedical, and psychosocial needs who can benefit from additional support to accommodate age-related changes in sensory and motor function. Objective: The purpose of this paper is to describe adaptations of the Centers for Disease Control and Prevention’s Diabetes Prevention Program aimed at preventing diabetes among older adults (ages ≥65 years) and findings from a pilot of 2 virtual sessions of the adapted program that evaluated the acceptability of the content. Methods: The research team adapted the program by incorporating additional resources necessary for older adults. A certified lifestyle coach delivered 2 sessions of the adapted content via videoconference to 189 older adults. Results: The first session had a 34.9% (38/109) response rate to the survey, and the second had a 34% (30/88) response rate. Over three-quarters (50/59, 85%) of respondents agreed that they liked the virtual program, with 82% (45/55) agreeing that they would recommend it to a family member or a friend. Conclusions: This data will be used to inform intervention delivery in a randomized controlled trial comparing in-person versus virtual delivery of the adapted program. %M 37642989 %R 10.2196/45004 %U https://formative.jmir.org/2023/1/e45004 %U https://doi.org/10.2196/45004 %U http://www.ncbi.nlm.nih.gov/pubmed/37642989 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48503 %T Evaluation of the Effectiveness of Assistive Technology for Executive Function Support for People With Acquired Brain Injury: Protocol for Single-Case Experimental Designs %A Bould,Em %A Tate,Robyn %A Simpson,Grahame %A Brusco,Natasha %A Licciardi,Lisa %A Callaway,Libby %+ Department of Occupational Therapy / Rehabilitation, Ageing and Independent Living (RAIL) Research Centre, Monash University, 47-49 Moorooduc Hwy, Frankston, 3199, Australia, 61 421 356 359, libby.callaway@monash.edu %K acquired brain injury %K assistive technology %K clinical research protocol %K economic evaluation %K executive function %K single-case experimental design %D 2023 %7 29.8.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Executive function, including prospective memory, initiating, planning, and sequencing everyday activities, is frequently affected by acquired brain injury (ABI). Executive dysfunction necessitates the use of compensatory cognitive strategies and, in more severe cases, human support over time. To compensate for the executive dysfunction experienced, growing options for electronic mainstream and assistive technologies may be used by people with ABI and their supporters. Objective: We outline the study protocol for a series of single-case experimental designs (SCEDs) to evaluate the effectiveness of smart home, mobile, and/or wearable technologies in reducing executive function difficulties following ABI. Methods: Up to 10 adults with ABI who experience executive dysfunction and have sufficient cognitive capacity to provide informed consent will be recruited across Victoria and New South Wales, Australia. Other key inclusion criteria are that they have substantial support needs for everyday living and reside in community dwellings. On the basis of the participant’s identified goal(s) and target behavior(s), a specific electronic assistive technology will be selected for application. Both identification of the target behavior(s) and selection of the assistive technology will be determined via consultation with each participant (and their key support person, if applicable). The choice of SCED will be individualized for each participant based on the type of technology used in the intervention, the difficulty level of the behavior targeted for change, and the anticipated rate of change. For each SCED, repeated measurements of the target behavior(s) during the baseline condition will provide performance data for comparison with the performance data collected during the intervention condition (with technology introduced). Secondary outcome measures will evaluate the impact of the intervention. The protocol includes 2 customizable Microsoft Excel spreadsheets for electronic record keeping. Results: Recruitment period is June 2022 through March 2024. Trial results for the individual participants will be graphed and analyzed separately using structured visual analysis supplemented with statistical analysis. Analysis will focus on important features of the data, including both within- and between-phase comparisons for response level, trend, variability, immediacy, consistency, and overlap. An exploratory economic evaluation will determine the impact on formal and informal support usage, together with quality of life, following the implementation of the new technological intervention. Conclusions: The study has been designed to test the cause-effect functional relationships between the intervention—in this case, electronic assistive technology—and its effect in changing the target behavior(s). The evaluation evidence gained will offer new insights into the application of various electronic assistive technologies for people who experience executive dysfunction following ABI. Furthermore, the results will help increase the capacity of key stakeholders to harness the potential of technology to build independence and reduce the cost of care for this population. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12622000835741, https://www.anzctr.org.au/ACTRN12622000835741.aspx International Registered Report Identifier (IRRID): DERR1-10.2196/48503 %M 37642985 %R 10.2196/48503 %U https://www.researchprotocols.org/2023/1/e48503 %U https://doi.org/10.2196/48503 %U http://www.ncbi.nlm.nih.gov/pubmed/37642985 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 9 %N %P e38515 %T Smartphone-Based Psychotherapeutic Interventions in Blended Care of Cancer Survivors: Nested Randomized Clinical Trial %A Meinlschmidt,Gunther %A Grossert,Astrid %A Meffert,Cornelia %A Roemmel,Noa %A Hess,Viviane %A Rochlitz,Christoph %A Pless,Miklos %A Hunziker,Sabina %A Wössmer,Brigitta %A Geuter,Ulfried %A Schaefert,Rainer %+ Department of Psychosomatic Medicine, University Hospital Basel, Hebelstrasse 2, Basel, 4031, Switzerland, 41 61 328 63 10, gunther.meinlschmidt@unibas.ch %K digital therapeutics %K ecological momentary assessment (EMA) %K ecological momentary intervention (EMI) %K internet- and mobile-based intervention %K microintervention %K neoplasm %K smartphone-based intervention %K postcancer treatment %K body psychotherapy %K mobile phone %D 2023 %7 28.8.2023 %9 Original Paper %J JMIR Cancer %G English %X Background: Cancer is related to not only physical but also mental suffering. Notably, body image disturbances are highly relevant to cancer-related changes often persisting beyond recovery from cancer. Scalable and low-barrier interventions that can be blended with face-to-face psychotherapy for cancer survivors are highly warranted. Objective: The aim of the study is to investigate whether smartphone-based bodily interventions are more effective to improve the mood of patients with cancer than smartphone-based fairy tale interventions (control intervention). Methods: We recruited patients with cancer in 2 Swiss hospitals and conducted daily, fully automated smartphone-based interventions 6 times a week for 5 consecutive weeks, blended with weekly face-to-face group body psychotherapy. We applied 2 types of smartphone-based interventions using a within-subject design, randomly assigning patients daily to either bodily interventions or fairy tales. Each intervention type was presented 3 times a week. For this secondary analysis, 3-level mixed models were estimated with mood assessed by the 3 Multidimensional Mood Questionnaire subscales for good-bad mood, wakefulness, and calmness as key indicators. In addition, the effects on experience of presence, vitality, and burden assessed with visual analog scales were investigated. Results: Based on the data from s=732 interventions performed by 36 participants, good-bad mood improved (β=.27; 95% CI 0.062-0.483), and participants became calmer (β=.98; 95% CI 0.740-1.211) following smartphone-based interventions. Wakefulness did not significantly change from pre- to postsmartphone–based intervention (β=.17; 95% CI –0.081 to 0.412). This was true for both intervention types. There was no interaction effect of intervention type with change in good-bad mood (β=–.01; 95% CI –0.439 to 0.417), calmness (β=.22; 95% CI –0.228 to 0.728), or wakefulness (β=.14; 95% CI –0.354 to 0.644). Experience of presence (β=.34; 95% CI 0.271-0.417) and vitality (β=.35; 95% CI 0.268-0.426) increased from pre- to postsmartphone–based intervention, while experience of burden decreased (β=–0.40; 95% CI –0.481 to 0.311). Again, these effects were present for both intervention types. There were no significant interaction effects of intervention type with pre- to postintervention changes in experience of presence (β=.14; 95% CI –0.104 to 0.384), experience of vitality (β=.06; 95% CI –0.152 to 0.265), and experience of burden (β=–.16; 95% CI –0.358 to 0.017). Conclusions: Our results suggest that both smartphone-based audio-guided bodily interventions and fairy tales have the potential to improve the mood of cancer survivors. Trial Registration: ClinicalTrials.gov NCT03707548; https://clinicaltrials.gov/study/NCT03707548 International Registered Report Identifier (IRRID): RR2-10.1186/s40359-019-0357-1 %M 37639296 %R 10.2196/38515 %U https://cancer.jmir.org/2023/1/e38515 %U https://doi.org/10.2196/38515 %U http://www.ncbi.nlm.nih.gov/pubmed/37639296 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e40260 %T A Digital Counselor-Delivered Intervention for Substance Use Among People With HIV: Development and Usability Study %A Hutton,Heidi E %A Aggarwal,Saavitri %A Gillani,Afroza %A Chander,Geetanjali %+ Department of Psychiatry & Behaviorial Science, Johns Hopkins University School of Medicine, 600 North Wolfe Street, Baltimore, MD, 21287, United States, 1 443 287 2874, hhutton@jhmi.edu %K computer-delivered intervention %K HIV %K substance use %K virtual counselor %K motivational interviewing %K people with HIV %K substance misuse %K virtual intervention %K evidence-based care %K engagement %K health outcome %K support %K behavioral intervention %K medical counseling %K patient care %K virtual care %K counseling %K mHealth %K telecounseling %D 2023 %7 28.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Substance use disorders are prevalent and undertreated among people with HIV. Computer-delivered interventions (CDIs) show promise in expanding reach, delivering evidence-based care, and offering anonymity. Use in HIV clinic settings may overcome access barriers. Incorporating digital counselors may increase CDI engagement, and thereby improve health outcomes. Objective: We aim to develop and pilot a digital counselor–delivered brief intervention for people with HIV who use drugs, called “C-Raven,” which is theory grounded and uses evidence-based practices for behavior change. Methods: Intervention mapping was used to develop the CDI including a review of the behavior change research in substance use, HIV, and digital counselors. We conducted in-depth interviews applying the situated-information, motivation, and behavior skills model and culturally adapting the content for local use with people with HIV. With a user interaction designer, we created various digital counselors and CDI interfaces. Finally, a mixed methods approach using in-depth interviews and quantitative assessments was used to assess the usability, acceptability, and cultural relevance of the intervention content and the digital counselor. Results: Participants found CDI easy to use, useful, relevant, and motivating. A consistent suggestion was to provide more information about the negative impacts of drug use and the interaction of drug use with HIV. Participants also reported that they learned new information about drug use and its health effects. The CDI was delivered by a “Raven,” digital counselor, programmed to interact in a motivational interviewing style. The Raven was perceived to be nonjudgmental, understanding, and emotionally responsive. The appearance and images in the intervention were perceived as relevant and acceptable. Participants noted that they could be more truthful with a digital counselor, however, it was not unanimously endorsed as a replacement for a human counselor. The C-Raven Satisfaction Scale showed that all participants rated their satisfaction at either a 4 (n=2) or a 5 (n=8) on a 5-point Likert scale and all endorsed using the C-Raven program again. Conclusions: CDIs show promise in extending access to care and improving health outcomes but their development necessarily requires integration from multiple disciplines including behavioral medicine and computer science. We developed a cross-platform compatible CDI led by a digital counselor that interacts in a motivational interviewing style and (1) uses evidence-based behavioral change methods, (2) is culturally adapted to people with HIV who use drugs, (3) has an engaging and interactive user interface, and (4) presents personalized content based on participants’ ongoing responses to a series of menu-driven conversations. To advance the continued development of this and other CDIs, we recommend expanded testing, standardized measures to evaluate user experience, integration with clinician-delivered substance use treatment, and if effective, implementation into HIV clinical care. %M 37639294 %R 10.2196/40260 %U https://formative.jmir.org/2023/1/e40260 %U https://doi.org/10.2196/40260 %U http://www.ncbi.nlm.nih.gov/pubmed/37639294 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e47284 %T Short-Term Findings From Testing EPIO, a Digital Self-Management Program for People Living With Chronic Pain: Randomized Controlled Trial %A Bostrøm,Katrine %A Børøsund,Elin %A Eide,Hilde %A Varsi,Cecilie %A Kristjansdottir,Ólöf Birna %A Schreurs,Karlein M G %A Waxenberg,Lori B %A Weiss,Karen E %A Morrison,Eleshia J %A Stavenes Støle,Hanne %A Cvancarova Småstuen,Milada %A Stubhaug,Audun %A Solberg Nes,Lise %+ Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Pb 4950 Nydalen, Oslo, N-0424, Norway, 47 91332341, lise.solberg.nes@rr-research.no %K chronic pain %K self-management %K digital health %K efficacy %K cognitive behavioral therapy %K acceptance and commitment therapy %D 2023 %7 25.8.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic pain conditions involve numerous physical and psychological challenges, and while psychosocial self-management interventions can be of benefit for people living with chronic pain, such in-person treatment is not always accessible. Digital self-management approaches could improve this disparity, potentially bolstering outreach and providing easy, relatively low-cost access to pain self-management interventions. Objective: This randomized controlled trial aimed to evaluate the short-term efficacy of EPIO (ie, inspired by the Greek goddess for the soothing of pain, Epione), a digital self-management intervention, for people living with chronic pain. Methods: Patients (N=266) were randomly assigned to either the EPIO intervention (n=132) or a care-as-usual control group (n=134). Outcome measures included pain interference (Brief Pain Inventory; primary outcome measure), anxiety and depression (Hospital Anxiety and Depression Scale), self-regulatory fatigue (Self-Regulatory Fatigue 18 scale), health-related quality of life (SF-36 Short Form Health Survey), pain catastrophizing (Pain Catastrophizing Scale), and pain acceptance (Chronic Pain Acceptance Questionnaire). Linear regression models used change scores as the dependent variables. Results: The participants were primarily female (210/259, 81.1%), with a median age of 49 (range 22-78) years and a variety of pain conditions. Analyses (n=229) after 3 months revealed no statistically significant changes for the primary outcome of pain interference (P=.84), but significant reductions in the secondary outcomes of depression (mean difference −0.90; P=.03) and self-regulatory fatigue (mean difference −2.76; P=.008) in favor of the intervention group. No other statistically significant changes were observed at 3 months (all P>.05). Participants described EPIO as useful (ie, totally agree or agree; 95/109, 87.2%) and easy to use (101/109, 92.7%), with easily understandable exercises (106/109, 97.2%). Conclusions: Evidence-informed, user-centered digital pain self-management interventions such as EPIO may have the potential to effectively support self-management and improve psychological functioning in the form of reduced symptoms of depression and improved capacity to regulate thoughts, feelings, and behavior for people living with chronic pain. Trial Registration: ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104 %M 37624622 %R 10.2196/47284 %U https://www.jmir.org/2023/1/e47284 %U https://doi.org/10.2196/47284 %U http://www.ncbi.nlm.nih.gov/pubmed/37624622 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e38447 %T Patient Portals as Facilitators of Engagement in Patients With Diabetes and Chronic Heart Disease: Scoping Review of Usage and Usability %A Scheckel,Benjamin %A Schmidt,Katharina %A Stock,Stephanie %A Redaèlli,Marcus %+ Institute of Health Economics and Clinical Epidemiology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Gleueler Str. 176-178, Cologne, 50935, Germany, 49 221 478 30925, Benjamin.Scheckel@uk-koeln.de %K patient portal %K eHealth %K online platform %K usability %K feasibility %K diabetes %K heart disease %D 2023 %7 25.8.2023 %9 Review %J J Med Internet Res %G English %X Background: Patient portals have the potential to improve care for chronically ill patients by engaging them in their treatment. These platforms can work, for example, as a standalone self-management intervention or a tethered link to treatment providers in routine care. Many different types of portals are available for different patient groups, providing various features. Objective: This scoping review aims to summarize the current literature on patient portals for patients with diabetes mellitus and chronic heart disease regarding usage behavior and usability. Methods: We conducted this review according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement for scoping reviews. We performed database searches using PubMed, PsycInfo, and CINAHL, as well as additional searches in reviews and reference lists. We restricted our search to 2010. Qualitative and quantitative studies, and studies using both approaches that analyzed usage behavior or usability of patient portals were eligible. We mapped portal features according to broad thematic categories and summarized the results of the included studies separately according to outcome and research design. Results: After screening, we finally included 85 studies. Most studies were about patients with diabetes, included patients younger than 65 years, and were conducted in the United States. Portal features were categorized into educational/general information, reminder, monitoring, interactivity, personal health information, electronic/personal health record, and communication. Portals mostly provided educational, monitoring, and communication-related features. Studies reported on usage behavior including associated variables, usability dimensions, and suggestions for improvement. Various ways of reporting usage frequency were identified. A noticeable decline in portal usage over time was reported frequently. Age was most frequently studied in association with portal use, followed by gender, education, and eHealth literacy. Younger age and higher education were often associated with higher portal use. In two-thirds of studies reporting on portal usability, the portals were rated as user friendly and comprehensible, although measurement and reporting were heterogeneous. Portals were considered helpful for self-management through positive influences on motivation, health awareness, and behavioral changes. Helpful features for self-management were educational/general information and monitoring. Barriers to portal use were general (eg, aspects of design or general usability), related to specific situations during portal use (eg, login procedure), or not portal specific (eg, user skills and preferences). Frequent themes were aspects of design, usability, and technology. Suggestions for improvement were mainly related to technical issues and need for support. Conclusions: The current state of research emphasizes the importance of involving patients in the development and evaluation of patient portals. The consideration of various research designs in a scoping review is helpful for a deeper understanding of usage behavior and usability. Future research should focus on the role of disease burden, and usage behavior and usability among older patients. %M 37624629 %R 10.2196/38447 %U https://www.jmir.org/2023/1/e38447 %U https://doi.org/10.2196/38447 %U http://www.ncbi.nlm.nih.gov/pubmed/37624629 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e44742 %T Efficacy of a Brief Blended Cognitive Behavioral Therapy Program for the Treatment of Depression and Anxiety in University Students: Uncontrolled Intervention Study %A Atik,Ece %A Stricker,Johannes %A Schückes,Magnus %A Pittig,Andre %+ Clinical Psychology Research Group, Department of Experimental Psychology, Heinrich Heine University Düsseldorf, Universitätsstr. 1, Düsseldorf, 40225, Germany, 49 211 81 10850, johannes.stricker@hhu.de %K blended cognitive behavioral therapy %K bCBT %K digital mental health %K e–mental health %K depression %K anxiety disorder %K video psychotherapy %K mobile phone %D 2023 %7 25.8.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Blended cognitive behavioral therapy (bCBT)—the combination of cognitive behavioral therapy and digital mental health applications—has been increasingly used to treat depression and anxiety disorders. As a resource-efficient treatment approach, bCBT appears promising for addressing the growing need for mental health care services, for example, as an early intervention before the chronification of symptoms. However, further research on the efficacy and feasibility of integrated bCBT interventions is needed. Objective: This study aimed to evaluate the efficacy of a novel bCBT program comprising short (25 min), weekly face-to-face therapy sessions combined with a smartphone-based digital health app for treating mild to moderate symptoms of depression or anxiety. Methods: This prospective uncontrolled trial comprised 2 measurement points (before and after treatment) and 2 intervention groups. We recruited university students with mild to moderate symptoms of depression or anxiety. On the basis of the primary symptoms, participants were assigned to either a depression intervention group (n=67 completers) or an anxiety intervention group (n=33 completers). Participants in each group received 6 weekly individual psychotherapy sessions via videoconference and completed modules tailored to their respective symptoms in the smartphone-based digital health app. Results: The depression group displayed medium to large improvements in the symptoms of depression (Cohen d=−0.70 to −0.90; P<.001). The anxiety group experienced significant improvements in the symptoms of generalized anxiety assessed with the Generalized Anxiety Disorder-7 scale with a large effect size (Cohen d=−0.80; P<.001) but not in symptoms of anxiety assessed with the Beck Anxiety Inventory (Cohen d=−0.35; P=.06). In addition, both groups experienced significant improvements in their perceived self-efficacy (Cohen d=0.50; P<.001 in the depression group and Cohen d=0.71; P<.001 in the anxiety group) and quality of life related to psychological health (Cohen d=0.87; P<.001 in the depression group and Cohen d=0.40; P=.03 in the anxiety group). Work and social adjustment of patients improved significantly in the depression group (Cohen d=−0.49; P<.001) but not in the anxiety group (Cohen d=−0.06; P=.72). Patients’ mental health literacy improved in the anxiety group (Cohen d=0.45; P=.02) but not in the depression group (Cohen d=0.21; P=.10). Patient satisfaction with the bCBT program and ratings of the usability of the digital app were high in both treatment groups. Conclusions: This study provides preliminary evidence for the feasibility and efficacy of a novel brief bCBT intervention. The intervention effects were generalized across a broad spectrum of patient-reported outcomes. Hence, the newly developed bCBT intervention appears promising for treating mild to moderate depression and anxiety in young adults. %M 37624631 %R 10.2196/44742 %U https://mental.jmir.org/2023/1/e44742 %U https://doi.org/10.2196/44742 %U http://www.ncbi.nlm.nih.gov/pubmed/37624631 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e49738 %T Exploring Patient Needs and Designing Concepts for Digitally Supported Health Solutions in Managing Type 2 Diabetes: Cocreation Study %A Persson,Dan Roland %A Zhukouskaya,Katiarina %A Wegener,Anne-Marie Karin %A Jørgensen,Lene Kølle %A Bardram,Jakob Eyvind %A Bækgaard,Per %+ Department of Applied Mathematics and Computer Science, Technical University of Denmark, Richard Petersens Plads, 321, room 112, Kgs. Lyngby, 2800, Denmark, 45 93511423, danrp@dtu.dk %K cocreation %K co-creation %K participatory design %K diabetes %K type 2 diabetes mellitus %K T2DM %K chronic illness %K personalized self-care %K mobile health %K mHealth %K eHealth %D 2023 %7 25.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Self-management of the progressive disease type 2 diabetes mellitus (T2DM) becomes part of the daily life of patients starting from the time of diagnosis. However, despite the availability of technical innovations, the uptake of digital solutions remains low. One reason that has been reported is that digital solutions often focus purely on clinical factors that may not align with the patient’s perspective. Objective: The aim of this study was to develop digital solutions that address the needs of patients with T2DM, designed from the user’s perspective. The goal was to address the patients’ expressed real-world needs by having the users themselves choose the scope and format of the solutions. Methods: Using participatory methods, we conducted 3 cocreation workshops in collaboration with the Danish Diabetes Association, with 20 persons with T2DM and 11 stakeholders across workshops: user experience designers, researchers, and diabetes experts including a diabetes nurse. The overall structure of the 3 workshops was aligned with the 4 phases of the double diamond: initially discovering and mapping out key experienced issues, followed by a workshop on thematic mapping and definition of key concepts, and succeeded by an exploration and development of 2 prototypes. Subsequently, high-fidelity interactive prototypes were refined as part of the delivery phase, in which 7 formative usability tests were conducted. Results: The workshops mapped experiential topics over time from prediagnosis to the current state, resulting in a detailed exploration and understanding of 6 themes related to and based on the experiences of patients with T2DM: diabetes care, diabetes knowledge, glucose monitoring, diet, physical activity, and social aspects of diabetes. Two prototypes were developed by the participants to address some of their expressed needs over time related to the 6 themes: an activity-based continuous glucose monitoring app and a web-based guide to diabetes. Both prototypes emphasize periods of structured self-measurements of blood glucose to support evolving needs for self-exploration through distinct phases of learning, active use, and supporting use. Periods of low or intermittent use may thus not reflect a failure of design in a traditional sense but rather be a sign of evolving needs over time. Conclusions: Our results indicate that the needs of patients with T2DM differ between individuals and change over time. As a result, the suggested digitally supported empowering health prototypes can be personalized to support self-exploration, individual preference in long-term management, and changing needs over time. Despite individuals experiencing different journeys with diabetes, users perceive the self-measurement of blood glucose as a universally useful tool to empower everyday decision-making. %M 37624633 %R 10.2196/49738 %U https://formative.jmir.org/2023/1/e49738 %U https://doi.org/10.2196/49738 %U http://www.ncbi.nlm.nih.gov/pubmed/37624633 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43676 %T Acceptability of the LetSync App Wireframes for an mHealth Intervention to Improve HIV Care Engagement and Treatment Among Black Partnered Sexual Minority Men: Findings from In-Depth Qualitative Interviews %A Becker,Nozipho %A Kim,Hyunjin C %A Bright,Darius J %A Williams III,Robert %A Anguera,Joaquin A %A Arnold,Emily A %A Saberi,Parya %A Neilands,Torsten B %A Pollack,Lance M %A Tan,Judy Y %+ Center for AIDS Prevention Studies, Division of Prevention Science, Department of Medicine, University of California San Francisco, 550 16th Street, 3rd Floor, San Francisco, CA, 94158, United States, 1 415 502 1000 ext 17163, judy.tan@ucsf.edu %K digital health %K mobile health %K mHealth %K mobile app %K app %K Black sexual minority men %K couples %K HIV care engagement %K HIV treatment %K United States %K mobile phone %D 2023 %7 25.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: HIV disparities continue to be a significant challenge affecting Black sexual minority men in the United States. Inadequate engagement and retention of patients in HIV care has been associated with poor health outcomes. Interventions to improve sustained commitment to HIV care are needed. Mobile health interventions can help facilitate access to and use of HIV health services, particularly among individuals at risk for disengaging with care. Objective: We designed the LetSync app wireframes for a mobile health intervention using a couple-centered design approach to improve HIV engagement and treatment among Black sexual minority men and their partners. The objective of this study was to gauge future app user interest and elicit feedback to improve the design, development, and usability of the LetSync app. Methods: We conducted in-depth interviews with 24 Black sexual minority men to assess the acceptability of the LetSync app wireframes between May 2020 and January 2021. Participants reviewed the LetSync app wireframes and provided feedback regarding perceived usefulness and interest in future app use and suggestions for improvement. Results: Participants indicated interest in the future LetSync app and noted that the wireframes’ features were acceptable and usable. In our study, the future LetSync app was frequently referred to as a potential resource that could help facilitate users’ engagement in HIV care through the following mechanisms: enable scheduling of appointments and timely reminders for clinic visits; help improve HIV medication adherence; encourage and motivate participants to ask questions to their health care provider and stay engaged in conversations during clinic visits; facilitate effective communication by assisting couples with planning, coordination, and management of daily routines; help participants understand their partner’s health needs, including access to and use of health care services; and facilitate participants’ ability to improve their relationship skills, partner support, and self-efficacy in managing conflict. In addition to near-universal interest in potential daily app use, study participants indicted that they would recommend the LetSync app to other family members, friends, and people in their social networks who are living with HIV. Conclusions: Our findings revealed considerable interest in future app use for HIV care management, which could possibly increase the chance of the LetSync app being successfully adopted by Black sexual minority men in couples. Owing to its interactive and couple-centered approach, the LetSync app could help improve communication between Black sexual minority men and their partners and health providers. In addition, the LetSync app could provide an acceptable modality for these men to receive support in accessing HIV care services. %M 37624634 %R 10.2196/43676 %U https://formative.jmir.org/2023/1/e43676 %U https://doi.org/10.2196/43676 %U http://www.ncbi.nlm.nih.gov/pubmed/37624634 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45963 %T Selective Prevention of Depression in Workers Using a Smartphone App: Randomized Controlled Trial %A Deady,Mark %A Collins,Daniel A J %A Lavender,Isobel %A Mackinnon,Andrew %A Glozier,Nicholas %A Bryant,Richard %A Christensen,Helen %A Harvey,Samuel B %+ Black Dog Institute, Faculty of Medicine and Health, University of New South Wales, Hospital Rd, Randwick, 2031, Australia, 61 02 9065 9144, m.deady@unsw.edu.au %K depression %K smartphone app %K workplace mental health %K randomized controlled trial %K prevention %K stress %K mobile phone %D 2023 %7 24.8.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: There is increasing evidence that depression can be prevented; however, universal approaches have had limited success. Appropriate targeting of interventions to at-risk populations has been shown to have potential, but how to selectively determine at-risk individuals remains unclear. Workplace stress is a risk factor for depression and a target for intervention, but few interventions exist to prevent depression among workers at risk due to heightened stress. Objective: This trial aimed to evaluate the efficacy of a smartphone-based intervention in reducing the onset of depression and improving related outcomes in workers experiencing at least moderate levels of stress. Methods: A randomized controlled trial was conducted with participants who were currently employed and reported no clinically significant depression and at least moderate stress. The intervention group (n=1053) were assigned Anchored, a 30-day self-directed smartphone app-based cognitive behavioral- and mindfulness-based intervention. The attention-control group (n=1031) were assigned a psychoeducation website. Assessment was performed via web-based self-report questionnaires at baseline and at 1-, 3-, and 6-month postbaseline time points. The primary outcome was new depression caseness aggregated over the follow-up period. The secondary outcomes included depressive and anxiety symptoms, stress, well-being, resilience, work performance, work-related burnout, and quality of life. Analyses were conducted within an intention-to-treat framework using mixed modeling. Results: There was no significant between-group difference in new depression caseness (z score=0.69; P=.49); however, those in the Anchored arm had significantly greater depressive symptom reduction at 1 month (Cohen d=0.02; P=.049) and 6 months (Cohen d=0.08; P=.03). Anchored participants also showed significantly greater reduction in anxiety symptoms at 1 month (Cohen d=0.07; P=.04) and increased work performance at 1 month (Cohen d=0.07; P=.008) and 6 months (Cohen d=0.13; P=.01), compared with controls. Notably, for Anchored participants completing at least two-thirds of the intervention, there was a significantly lower rate of depression onset (1.1%, 95% CI 0.0%-3.7%) compared with controls (9.0%, 95% CI 6.8%-12.3%) at 1 month (z score=4.50; P<.001). Significant small to medium effect sizes for most secondary outcomes were seen in the highly engaged Anchored users compared with controls, with effects maintained at the 6-month follow-up for depressive symptoms, well-being, stress, and quality of life. Conclusions: Anchored was associated with a small comparative reduction in depressive symptoms compared with controls, although selective prevention of case-level depression was not observed in the intention-to-treat analysis. When users adequately engaged with the app, significant findings pertaining to depression prevention, overall symptom reduction, and functional improvement were found, compared with controls. There is a need for a greater focus on engagement techniques in future research. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000178943; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378592 %M 37616040 %R 10.2196/45963 %U https://www.jmir.org/2023/1/e45963 %U https://doi.org/10.2196/45963 %U http://www.ncbi.nlm.nih.gov/pubmed/37616040 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45836 %T Effects of a Nonwearable Digital Therapeutic Intervention on Preschoolers With Autism Spectrum Disorder in China: Open-Label Randomized Controlled Trial %A Chu,Liting %A Shen,Li %A Ma,Chenhuan %A Chen,Jinjin %A Tian,Yuan %A Zhang,Chuncao %A Gong,Zilan %A Li,Mengfan %A Wang,Chengjie %A Pan,Lizhu %A Zhu,Peiying %A Wu,Danmai %A Wang,Yu %A Yu,Guangjun %+ School of Medicine, The Chinese University of Hong Kong, No 2001 Longxiang Avenue, Shenzhen, 518172, China, 86 755 8427 3000, guangjunyu@cuhk.edu.cn %K autism spectrum disorder %K digital therapy %K nonwearable %K preschoolers %K randomized controlled trial %K autism %K neurodevelopmental disorder %K difficulty with communication %K social interaction %K ADHD %K attention-deficit/hyperactivity disorder %K digital therapy %K digital intervention %D 2023 %7 24.8.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Autism spectrum disorder (ASD) is a neurodevelopmental disorder that can cause difficulty with communication and social interactions as well as complicated family dynamics. Digital health interventions can reduce treatment costs and promote healthy lifestyle changes. These therapies can be adjunctive or replace traditional treatments. However, issues with cooperation and compliance prevent preschool patients with ASD from applying these tools. In this open-label, randomized controlled trial, we developed a nonwearable digital therapy called virtual reality–incorporated cognitive behavioral therapy (VR-CBT). Objective: The aim of this study was to assess the adjunctive function of VR-CBT by comparing the effects of VR-CBT plus learning style profile (LSP) intervention with those of LSP-only intervention in preschool children with ASD. Methods: This trial was performed in China on 78 preschool children (age 3-6 years, IQ>70) diagnosed with ASD who were randomized to receive a 20-week VR-CBT plus LSP intervention (intervention group, 39/78, 50%) or LSP intervention only (control group, 39/78, 50%). The primary outcome was the change of scores from baseline to week 20, assessed by using the parent-rated Autism Behavior Checklist (ABC). Secondary outcomes included the Childhood Autism Rating Scale (CARS), Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV), and behavioral performance data (accuracy and reaction time) in go/no-go tasks. All primary and secondary outcomes were analyzed in the intention-to-treat population. Results: After the intervention, there was an intervention effect on total ABC (β=–5.528; P<.001) and CARS scores (β=–1.365; P=.02). A similar trend was observed in the ABC subscales: sensory (β=–1.133; P=.047), relating (β=–1.512; P=.03), body and object use (β=–1.211; P=.03), and social and self-help (β=–1.593; P=.03). The intervention also showed statistically significant effects in improving behavioral performance (go/no-go task, accuracy, β=2.923; P=.04). Moreover, a significant improvement of ADHD hyperactivity-impulsivity symptoms was observed in 53 children with comorbid ADHD based on ADHD-RS-IV (β=–1.269; P=.02). No statistically significant intervention effect was detected in the language subscale of ABC (β=–.080; P=.83). Intervention group girls had larger improvements in ABC subscales, that is, sensory and body and object use and in the CARS score and accuracy of go/no-go task (all P<.05) than the control group girls. Statistically significant intervention effects could be observed in hyperactivity-impulsivity symptoms in the intervention group boys with comorbid ADHD compared with those in the control group boys (β=–1.333; P=.03). Conclusions: We found potentially positive effects of nonwearable digital therapy plus LSP on core symptoms associated with ASD, leading to a modest improvement in the function of sensory, motor, and response inhibition, while reducing impulsivity and hyperactivity in preschoolers with both ASD and ADHD. VR-CBT was found to be an effective and feasible adjunctive digital tool. Trial Registration: Chinese Clinical Trial Registry ChiCTR2100053165; http://www.chictr.org.cn/showproj.aspx?proj=137016 %M 37616029 %R 10.2196/45836 %U https://www.jmir.org/2023/1/e45836 %U https://doi.org/10.2196/45836 %U http://www.ncbi.nlm.nih.gov/pubmed/37616029 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 7 %N %P e43489 %T Long-Term Results of a Digital Hypertension Self-Management Program: Retrospective Cohort Study %A Wu,Justin %A Napoleone,Jenna %A Linke,Sarah %A Noble,Madison %A Turken,Michael %A Rakotz,Michael %A Kirley,Kate %A Folk Akers,Jennie %A Juusola,Jessie %A Jasik,Carolyn Bradner %+ Omada Health Inc, 500 Sansome St., San Francisco, CA, 94111, United States, 1 415 533 7043, justin.wu@omadahealth.com %K hypertension %K digital health program %K home measurement %K self-management %K behavior change %D 2023 %7 24.8.2023 %9 Original Paper %J JMIR Cardio %G English %X Background: Digital health programs that incorporate frequent blood pressure (BP) self-monitoring and support for behavior change offer a scalable solution for hypertension management. Objective: We examined the impact of a digital hypertension self-management and lifestyle change support program on BP over 12 months. Methods: Data were analyzed from a retrospective observational cohort of commercially insured members (n=1117) that started the Omada for Hypertension program between January 1, 2019, and September 30, 2021. Paired t tests and linear regression were used to measure the changes in systolic blood pressure (SBP) over 12 months overall and by SBP control status at baseline (≥130 mm Hg vs <130 mm Hg). Results: Members were on average 50.9 years old, 50.8% (n=567) of them were female, 60.5% (n=675) of them were White, and 70.5% (n=788) of them had uncontrolled SBP at baseline (≥130 mm Hg). At 12 months, all members (including members with controlled and uncontrolled BP at baseline) and those with uncontrolled SBP at baseline experienced significant mean reductions in SBP (mean –4.8 mm Hg, 95% CI –5.6 to –4.0; –8.1 mm Hg, 95% CI –9.0 to –7.1, respectively; both P<.001). Members with uncontrolled SBP at baseline also had significant reductions in diastolic blood pressure (–4.7 mm Hg; 95% CI –5.3 to –4.1), weight (–6.5 lbs, 95% CI –7.7 to –5.3; 2.7% weight loss), and BMI (–1.1 kg/m2; 95% CI –1.3 to –0.9; all P<.001). Those with controlled SBP at baseline maintained within BP goal range. Additionally, 48% (418/860) of members with uncontrolled BP at baseline experienced enough change in BP to improve their BP category. Conclusions: This study provides real-world evidence that a comprehensive digital health program involving hypertension education, at-home BP monitoring, and behavior change coaching support was effective for self-managing hypertension over 12 months. %M 37463311 %R 10.2196/43489 %U https://cardio.jmir.org/2023/1/e43489 %U https://doi.org/10.2196/43489 %U http://www.ncbi.nlm.nih.gov/pubmed/37463311 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 6 %N %P e45859 %T Development and Initial Evaluation of Web-Based Cognitive Behavioral Therapy for Insomnia in Rural Family Caregivers of People With Dementia (NiteCAPP): Mixed Methods Study %A McCrae,Christina S %A Curtis,Ashley F %A Stearns,Melanie A %A Nair,Neetu %A Golzy,Mojgan %A Shenker,Joel I %A Beversdorf,David Q %A Cottle,Amelia %A Rowe,Meredeth A %+ College of Nursing, University of South Florida, 12912 USF Health Dr, Tampa, FL, 33612, United States, 1 813 974 1804, christinamccrae@usf.edu %K arousal %K caregivers %K cognitive behavioral therapy %K CBT: cognitive behavioral therapy for insomnia %K CBT-I %K dementia %K insomnia %K internet %D 2023 %7 24.8.2023 %9 Original Paper %J JMIR Aging %G English %X Background: Informal caregivers of people with dementia frequently experience chronic insomnia, contributing to stress and poor health outcomes. Rural caregivers are particularly vulnerable but have limited access to cognitive behavioral therapy for insomnia (CBT-I), a recommended frontline treatment for chronic insomnia. Web-based delivery promises to improve insomnia, particularly for rural caregivers who have limited access to traditional in-person treatments. Our team translated an efficacious 4-session standard CBT-I content protocol into digital format to create NiteCAPP. Objective: This study aimed to (1) adapt NiteCAPP for dementia caregivers to create NiteCAPP CARES, a tailored digital format with standard CBT-I content plus caregiver-focused modifications; (2) conduct usability testing and evaluate acceptability of NiteCAPP CARES’ content and features; and (3) pilot-test the adapted intervention to evaluate feasibility and preliminary effects on sleep and related health outcomes. Methods: We followed Medical Research Council recommendations for evaluating complex medical interventions to explore user needs and adapt and validate content using a stepwise approach: (1) a rural dementia caregiver (n=5) and primary care provider (n=5) advisory panel gave feedback that was used to adapt NiteCAPP; (2) caregiver (n=5) and primary care provider (n=7) focus groups reviewed the newly adapted NiteCAPP CARES and provided feedback that guided further adaptations; and (3) NiteCAPP CARES was pilot-tested in caregivers (n=5) for feasibility and to establish preliminary effects. Self-report usability measures were collected following intervention. Before and after treatment, 14 daily electronic sleep diaries and questionnaires were collected to evaluate arousal, health, mood, burden, subjective cognition, and interpersonal processes. Results: The stepped approach provided user and expert feedback on satisfaction, usefulness, and content, resulting in a new digital CBT-I tailored for rural dementia caregivers: NiteCAPP CARES. The advisory panel recommended streamlining content, eliminating jargon, and including caregiver-focused content. Focus groups gave NiteCAPP CARES high usefulness ratings (mean score 4.4, SD 0.79, scored from 1=least to 5=most favorable; score range 4.2-4.8). Multiple features were evaluated positively, including the intervention’s comprehensive and engaging information, caregiver focus, good layout, easy-to-access intervention material, and easy-to-understand sleep graphs. Suggestions for improvement included the provision of day and night viewing options, collapsible text, font size options, tabbed access to videos, and a glossary of terms. Pilot-test users rated usefulness (mean score 4.3, SD 0.83; range 4.1-4.5) and satisfaction (mean score 8.4, SD 1.41, scored from 1=least to 10=most satisfied; range 7.4-9.0) highly. Preliminary effects on caregiver sleep, arousal, health, mood, burden, cognition, and interpersonal processes (all P<.05) were promising. Conclusions: Adaptations made to standard digital CBT-I created a feasible, tailored digital intervention for rural dementia caregivers. Important next steps include further examination of feasibility and efficacy in a randomized controlled trial with an active control condition, a multisite effectiveness trial, and eventual broad dissemination. Trial Registration: ClinicalTrials.gov NCT04632628; https://clinicaltrials.gov/ct2/show/NCT04632628 %M 37616032 %R 10.2196/45859 %U https://aging.jmir.org/2023/1/e45859 %U https://doi.org/10.2196/45859 %U http://www.ncbi.nlm.nih.gov/pubmed/37616032 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e48113 %T An mHealth-Delivered Sexual Harm Reduction Tool (PartyPack) for Men Who Have Sex With Men in Malaysia: Usability Study %A Gautam,Kamal %A Paudel,Kiran %A Jacobs,Jerome %A Wickersham,Jeffrey A %A Ikhtiaruddin,Wan Mohd %A Azwa,Iskandar %A Saifi,Rumana %A Lim,Sin How %A Shrestha,Roman %+ Department of Allied Health Sciences, University of Connecticut, 358 Mansfield Rd, Storrs, CT, 06269, United States, 1 860 486 2834, roman.shrestha@uconn.edu %K chemsex %K party and play %K sexualized drug use %K PartyPack %K harm reduction tool %K men who have sex with men %K Malaysia %K health promotion %K sexual health %K mHealth intervention %K HIV prevention %D 2023 %7 24.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Chemsex—the use of psychoactive drugs to enhance the sexual experience—is an increasing phenomenon globally. Despite the increasing burden and associated harms of chemsex, evidence-based interventions (ie, behavioral and pharmacological) for chemsex users are nonexistent. Objective: In this study, we assessed the usability and acceptability of a mobile health (mHealth)–delivered safer chemsex package (“PartyPack”) as a sexual harm reduction strategy among men who have sex with men in Malaysia—a setting where chemsex is becoming increasingly prevalent. Methods: This study is part of a larger smartphone app-based intervention (ie, JomPrEP; University of Connecticut) designed to improve access to HIV prevention services among Malaysian men who have sex with men. A total of 50 participants were recruited from the Greater Kuala Lumpur region of Malaysia to use the JomPrEP app, which included a feature allowing participants to order PartyPack, for 30 days (March-April 2022). The usability and acceptability of the PartyPack were assessed using self-report, app analytics, and exit interviews (n=20). Results: Overall, 8% (4/50) of participants reported having engaged in chemsex in the past 6 months; however, engagement in condomless sex (34/50, 68%) and group sex (9/50, 18%) was much higher. A total of 43 (86%) participants ordered PartyPack, of which 27 (63%) made multiple orders during the 30 days. Most participants (41/43, 95%) reported being satisfied with the PartyPack order feature in the app, with 91% (39/43) indicating the order and tracking process was easy. Thematic data exploration further revealed important information for understanding (eg, items included in the package, use of mHealth platform to order package, and discreetness of the PartyPack box and order and delivery) and refining the logistical preferences (eg, using branded items and allowing customization during order). Conclusions: Our findings provide strong evidence of the usability and acceptability of a mHealth-delivered safer chemsex package as a potential sexual harm reduction tool among this underserved population. Replication in a study with a larger sample size to test the efficacy of the PartyPack is warranted. %M 37616034 %R 10.2196/48113 %U https://formative.jmir.org/2023/1/e48113 %U https://doi.org/10.2196/48113 %U http://www.ncbi.nlm.nih.gov/pubmed/37616034 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42921 %T Web-Based Video Education to Improve Uptake of Influenza Vaccination and Other Preventive Health Recommendations in Adults With Inflammatory Bowel Disease: Randomized Controlled Trial of Project PREVENT %A Long,Millie D %A van Deen,Welmoed K %A Weisbein,Laura %A Khalil,Carine %A Appel,Keren L %A Zhang,Xian %A Chen,Wenli %A Zubrod,Lori %A Maris,Robbie %A Ghafari,Afsoon %A Dupuy,Taylor %A Ha,Christina Y %A Spiegel,Brennan M R %A Almario,Christopher V %A Melmed,Gil Y %+ Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, University of Chapel Hill, 130 Mason Farm Rd, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599-7080, United States, 1 919 962 2211, millie_long@med.unc.edu %K preventative %K education %K inflammatory bowel disease (IBD) %K education %K adults %K inflammation %K disease %K risk %K infections %K bone %K cancer %K development %K patient %K interview %K intervention %K prevention %K vaccination %K influenza %D 2023 %7 23.8.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Patients with inflammatory bowel disease (IBD) are at increased risk of infections, bone fractures, and skin cancers. Objective: We developed preventive health videos using a patient-centered approach and tested their impact on preventive health uptake. Methods: Five animated videos explaining preventive health recommendations in IBD were iteratively developed with patient-centered focus groups and interviews. A randomized controlled trial was then conducted in a web-based IBD cohort to test the impact of video- versus text-based educational interventions. The primary outcome was receipt of the influenza vaccine. Secondary outcomes included intention to receive other preventive health services. Results: Five animated videos were developed with patient input. A total of 1056 patients with IBD were then randomized to receive the video (n=511) or text-only (n=545) interventions; 55% (281/511) of the video group and 57% (311/545) of the text-only group had received their influenza vaccine in the prior year. Immediately after the intervention, 73% (502/683) of patients reported their intention to receive the vaccine, with no difference by the type of intervention (75%, 231/307, for the video group and 72%, 271/376, for the text-only group). The proportion of patients who actually received the influenza vaccine after the intervention also did not differ by messaging type (P=.07). The strongest predictor of both intention to receive and actual receipt of the influenza vaccine was prior influenza vaccination. Older age was also associated with a higher likelihood of the intention to receive (age 36-75 years relative to 18-35 years; P=.006) and actual receipt (age >75 years relative to 18-35 years; P=.05) of the influenza vaccine. Conclusions: The proportion of patients receiving the influenza vaccine was high in both groups, but there was no difference in receipt of or in the intention to receive preventive health recommendations by type of messaging. Notably, a portion of patients in both groups had intended to be vaccinated but did not ultimately receive the vaccine. Further evaluation of patient-education strategies is warranted to improve preventive health uptake among patients with IBD. Trial Registration: ClinicalTrials.gov NCT05997537; https://clinicaltrials.gov/ct2/show/NCT05997537 %M 37610821 %R 10.2196/42921 %U https://www.jmir.org/2023/1/e42921 %U https://doi.org/10.2196/42921 %U http://www.ncbi.nlm.nih.gov/pubmed/37610821 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e46949 %T Mobile Technologies for Supporting Mental Health in Youths: Scoping Review of Effectiveness, Limitations, and Inclusivity %A Litke,Shannon Grace %A Resnikoff,Annie %A Anil,Ashley %A Montgomery,Meredith %A Matta,Rishabh %A Huh-Yoo,Jina %A Daly,Brian P %+ Department of Psychological and Brain Sciences, Drexel University, Stratton Hall Suite 118/119, 3201 Chestnut Street, Philadelphia, PA, 19104, United States, 1 7329938165, sgl46@drexel.edu %K mHealth %K mobile app %K children %K adolescents %K mental health %K effectiveness %K efficacy %K scoping review %K mobile phone %D 2023 %7 23.8.2023 %9 Review %J JMIR Ment Health %G English %X Background: Over the past decade, there has been growing support for the use of mobile health (mHealth) technologies to improve the availability of mental health interventions. While mHealth is a promising tool for improving access to interventions, research on the effectiveness and efficacy of mHealth apps for youths is limited, particularly for underrepresented populations, including youths of color and economically marginalized youths. Objective: This scoping review study sought to evaluate the following research questions: (1) What is the extent of the current literature on mHealth apps that provide intervention for mental health problems in children and adolescents? (2) What is known from the existing literature about the effectiveness or efficacy of delivering mental health services via mHealth apps? (3) What are the gaps in the knowledge base in the fields of technology and mental health? (4) Do the reviewed mHealth apps address issues of cultural sensitivity or have they been tested with underrepresented groups (ie, youths of color or economically marginalized groups)? Methods: An electronic database search was conducted using relevant search terms. Seven independent reviewers screened identified studies, including title and abstract review to determine if studies met the following inclusion criteria: (1) targeted samples with mental health symptomology or disorders, (2) studied youth participants aged 6-17 years, and (3) examined the use of a mobile app–based platform for intervention. Relevant studies were subjected to full-text review to extract and chart relevant data based on a priori research questions. Results: The initial database search yielded 304 papers published from 2010 to 2021. After screening and selection, the final review included 10 papers on the effectiveness and efficacy of mental health intervention apps for youths aged 8 to 17 years. Identified apps targeted a broad range of mental health challenges in youths (ie, depression, self-harm, autism spectrum disorder, anxiety, and obsessive-compulsive disorder). Results identified only a small number of studies suggesting that current effectiveness and efficacy research in this area are limited. While some studies provided general support for the effectiveness of mHealth apps in improving mental health outcomes in youths, several notable limitations were present across the literature, reducing the generalizability of findings. Additionally, considerations around racial, ethnic, and socioeconomic diversity were scarce across studies. Conclusions: Although some studies cited in this scoping review provide support for the effectiveness and efficacy of mHealth apps targeting mental health concerns in youths, the overall body of literature remains quite limited. Moreover, mHealth apps expressly developed to be culturally responsive are almost nonexistent. Further efforts are needed to recruit youths who are typically underrepresented in research and invite stakeholder participation and collaborative input in the early stages of the mHealth app development process. %M 37610818 %R 10.2196/46949 %U https://mental.jmir.org/2023/1/e46949 %U https://doi.org/10.2196/46949 %U http://www.ncbi.nlm.nih.gov/pubmed/37610818 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44267 %T Developing Culturally Appropriate Content for a Child-Rearing App to Support Young Children’s Socioemotional and Cognitive Development in Afghanistan: Co-Design Study %A LaMonica,Haley M %A Crouse,Jacob J %A Song,Yun J C %A Alam,Mafruha %A Wilson,Chloe E %A Hindmarsh,Gabrielle %A Yoon,Adam %A Boulton,Kelsie A %A Ekambareshwar,Mahalakshmi %A Loblay,Victoria %A Troy,Jakelin %A Torwali,Mujahid %A Guastella,Adam J %A Banati,Richard B %A Hickie,Ian B %+ Youth Mental Health and Technology Team, Brain and Mind Centre, The University of Sydney, 94 Mallett Street, Sydney, 2050, Australia, 61 426955658, haley.lamonica@sydney.edu.au %K child development %K digital technology %K global health %K co-design %K participatory research %K stakeholder participation %K mobile app %K smartphone %K mobile phone %K Afghanistan %D 2023 %7 23.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Optimal child-rearing practices can help mitigate the consequences of detrimental social determinants of health in early childhood. Given the ubiquity of personal digital technologies worldwide, the direct delivery of evidence-based information about early childhood development holds great promise. However, to make the content of these novel systems effective, it is crucial to incorporate place-based cultural beliefs, traditions, circumstances, and value systems of end users. Objective: This paper describes the iterative approach used to develop the Thrive by Five child-rearing app in collaboration with Afghan parents, caregivers (eg, grandparents, aunts, and nannies), and subject matter experts (SMEs). We outline how co-design methodologies informed the development and cultural contextualization of content to meet the specific needs of Afghan parents and the content was tested and refined in collaboration with key Afghan stakeholders. Methods: The preliminary content was developed based on a comprehensive literature review of the historical and sociocultural contexts in Afghanistan, including factors that influence child-rearing practices and early childhood development. After an initial review and refinement based on feedback from SMEs, this content was populated into a beta app for testing. Overall, 8 co-design workshops were conducted in July and August 2021 and February 2022 with 39 Afghan parents and caregivers and 6 SMEs to collect their feedback on the app and its content. The workshops were audio recorded and transcribed; detailed field notes were taken by 2 scribes. A theoretical thematic analysis using semantic codes was conducted to inform the refinement of existing content and development of new content to fulfill the needs identified by participants. Results: The following 4 primary themes were identified: child-rearing in the Afghan sociocultural context, safety concerns, emotion and behavior management, and physical health and nutrition. Overall, participants agreed that the app had the potential to deliver valuable information to Afghan parents; however, owing to the volatility in the country, participants recommended including more activities that could be safely done indoors, as mothers and children are required to spend most of their time at home. Additionally, restrictions on public engagement in music required the removal of activities referencing singing that might be performed outside the home. Further, activities to help parents reduce their children’s screen time, promote empathy, manage emotions, regulate behavior, and improve physical health and nutrition were requested. Conclusions: Direct engagement with Afghan parents, caregivers, and SMEs through co-design workshops enabled the development and refinement of evidence-based, localized, and contextually relevant child-rearing activities promoting healthy social, emotional, and cognitive development during the first 5 years of children’s lives. Importantly, the content was adapted for the ongoing conflict in Afghanistan with the aim of empowering Afghan parents and caregivers to support their children’s developmental potential despite the security concerns and situational stressors. %M 37610805 %R 10.2196/44267 %U https://formative.jmir.org/2023/1/e44267 %U https://doi.org/10.2196/44267 %U http://www.ncbi.nlm.nih.gov/pubmed/37610805 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45133 %T Effects of Increased Standing and Light-Intensity Physical Activity to Improve Postprandial Glucose in Sedentary Office Workers: Protocol for a Randomized Crossover Trial %A Wilson,Shannon L %A Crosley-Lyons,Rachel %A Junk,Jordan %A Hasanaj,Kristina %A Larouche,Miranda L %A Hollingshead,Kevin %A Gu,Haiwei %A Whisner,Corrie %A Sears,Dorothy D %A Buman,Matthew P %+ College of Health Solutions, Arizona State University, 500 North 3rd Street, Phoenix, AZ, 85004, United States, 1 602 496 8617, mbuman@asu.edu %K sitting bouts %K digital health intervention %K standing desk %K endothelial function %K glycemic control %K sleep %K blood pressure %K insulin %K mHealth %D 2023 %7 23.8.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Prolonged bouts of sedentary time, independent from the time spent in engaging in physical activity, significantly increases cardiometabolic risk. Nonetheless, the modern workforce spends large, uninterrupted portions of the day seated at a desk. Previous research suggests—via improved cardiometabolic biomarkers—that this risk might be attenuated by simply disrupting sedentary time with brief breaks of standing or moving. However, this evidence is derived from acute, highly controlled laboratory experiments and thus has low external validity. Objective: This study aims to investigate if similar or prolonged cardiometabolic changes are observed after a prolonged (2-week) practice of increased brief standing and moving behaviors in real-world office settings. Methods: This randomized crossover trial, called the WorkWell Study, will compare the efficacy of two 2-week pilot intervention conditions designed to interrupt sitting time in sedentary office workers (N=15) to a control condition. The intervention conditions use a novel smartphone app to deliver real-time prompts to increase standing (STAND) or moving (MOVE) by an additional 6 minutes each hour during work. Our primary aim is to assess intervention-associated improvements to daily postprandial glucose using continuous glucose monitors. Our secondary aim is to determine whether the interventions successfully evoke substantive positional changes and light-intensity physical activity (LPA). Other outcomes include the feasibility and acceptability of the intervention conditions, fasting blood glucose concentration, femoral artery flow-mediated dilation (f-FMD), and systolic and diastolic blood pressure. Results: The trial is ongoing at the time of submission. Conclusions: This study is a novel, randomized crossover trial designed to extend a laboratory-based controlled study design into the free-living environment. By using digital health technologies to monitor and prompt participants in real time, we will be able to rigorously test the effects of breaking up sedentary behavior over a longer period of time than is seen in traditional laboratory-based studies. Our innovative approach will leverage the strengths of highly controlled laboratory and free-living experiments to achieve maximal internal and external validity. The research team’s multidisciplinary expertise allows for a broad range of biological measures to be sampled, providing robust results that will extend knowledge of both the acute and chronic real-life effects of increased standing and LPA in sedentary office workers. The WorkWell Study uses a rigorous transdisciplinary protocol that will contribute to a more comprehensive picture of the beneficial effects of breaking up sitting behavior. Trial Registration: ClinicalTrials.gov NCT04269070; https://clinicaltrials.gov/study/NCT04269070 International Registered Report Identifier (IRRID): DERR1-10.2196/45133 %M 37610800 %R 10.2196/45133 %U https://www.researchprotocols.org/2023/1/e45133 %U https://doi.org/10.2196/45133 %U http://www.ncbi.nlm.nih.gov/pubmed/37610800 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45834 %T Effect of an Internet–Delivered Cognitive Behavioral Therapy–Based Sleep Improvement App for Shift Workers at High Risk of Sleep Disorder: Single-Arm, Nonrandomized Trial %A Ito-Masui,Asami %A Sakamoto,Ryota %A Matsuo,Eri %A Kawamoto,Eiji %A Motomura,Eishi %A Tanii,Hisashi %A Yu,Han %A Sano,Akane %A Imai,Hiroshi %A Shimaoka,Motomu %+ Department of Molecular Pathology & Cell Adhesion Biology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan, 81 59 231 5031, motomushimaoka@gmail.com %K shift worker sleep disorder %K internet-based cognitive behavioral therapy %K mobile apps %K fitness tracker %K subjective well-being %K machine learning %K mobile phone %D 2023 %7 22.8.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Shift workers are at high risk of developing sleep disorders such as shift worker sleep disorder or chronic insomnia. Cognitive behavioral therapy (CBT) is the first-line treatment for insomnia, and emerging evidence shows that internet-based CBT is highly effective with additional features such as continuous tracking and personalization. However, there are limited studies on internet-based CBT for shift workers with sleep disorders. Objective: This study aimed to evaluate the impact of a 4-week, physician-assisted, internet-delivered CBT program incorporating machine learning–based well-being prediction on the sleep duration of shift workers at high risk of sleep disorders. We evaluated these outcomes using an internet-delivered CBT app and fitness trackers in the intensive care unit. Methods: A convenience sample of 61 shift workers (mean age 32.9, SD 8.3 years) from the intensive care unit or emergency department participated in the study. Eligible participants were on a 3-shift schedule and had a Pittsburgh Sleep Quality Index score ≥5. The study comprised a 1-week baseline period, followed by a 4-week intervention period. Before the study, the participants completed questionnaires regarding the subjective evaluation of sleep, burnout syndrome, and mental health. Participants were asked to wear a commercial fitness tracker to track their daily activities, heart rate, and sleep for 5 weeks. The internet-delivered CBT program included well-being prediction, activity and sleep chart, and sleep advice. A job-based multitask and multilabel convolutional neural network–based model was used for well-being prediction. Participant-specific sleep advice was provided by sleep physicians based on daily surveys and fitness tracker data. The primary end point of this study was sleep duration. For continuous measurements (sleep duration, steps, etc), the mean baseline and week-4 intervention data were compared. The 2-tailed paired t test or Wilcoxon signed rank test was performed depending on the distribution of the data. Results: In the fourth week of intervention, the mean daily sleep duration for 7 days (6.06, SD 1.30 hours) showed a statistically significant increase compared with the baseline (5.54, SD 1.36 hours; P=.02). Subjective sleep quality, as measured by the Pittsburgh Sleep Quality Index, also showed statistically significant improvement from baseline (9.10) to after the intervention (7.84; P=.001). However, no significant improvement was found in the subjective well-being scores (all P>.05). Feature importance analysis for all 45 variables in the prediction model showed that sleep duration had the highest importance. Conclusions: The physician-assisted internet-delivered CBT program targeting shift workers with a high risk of sleep disorders showed a statistically significant increase in sleep duration as measured by wearable sensors along with subjective sleep quality. This study shows that sleep improvement programs using an app and wearable sensors are feasible and may play an important role in preventing shift work–related sleep disorders. International Registered Report Identifier (IRRID): RR2-10.2196/24799. %M 37606971 %R 10.2196/45834 %U https://www.jmir.org/2023/1/e45834 %U https://doi.org/10.2196/45834 %U http://www.ncbi.nlm.nih.gov/pubmed/37606971 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45589 %T Using Machine Learning of Online Expression to Explain Recovery Trajectories: Content Analytic Approach to Studying a Substance Use Disorder Forum %A Yang,Ellie Fan %A Kornfield,Rachel %A Liu,Yan %A Chih,Ming-Yuan %A Sarma,Prathusha %A Gustafson,David %A Curtin,John %A Shah,Dhavan %+ School of Communication and Mass Media, Northwest Missouri State University, 800 University Dr, 239 Wells Hall, Maryville, MO, 64468, United States, 1 6605621618, eyang@nwmissouri.edu %K supervised machine learning %K online peer support forum %K expression effects %K content analysis %K substance use disorder %K mobile phone %D 2023 %7 22.8.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Smartphone-based apps are increasingly used to prevent relapse among those with substance use disorders (SUDs). These systems collect a wealth of data from participants, including the content of messages exchanged in peer-to-peer support forums. How individuals self-disclose and exchange social support in these forums may provide insight into their recovery course, but a manual review of a large corpus of text by human coders is inefficient. Objective: The study sought to evaluate the feasibility of applying supervised machine learning (ML) to perform large-scale content analysis of an online peer-to-peer discussion forum. Machine-coded data were also used to understand how communication styles relate to writers’ substance use and well-being outcomes. Methods: Data were collected from a smartphone app that connects patients with SUDs to online peer support via a discussion forum. Overall, 268 adult patients with SUD diagnoses were recruited from 3 federally qualified health centers in the United States beginning in 2014. Two waves of survey data were collected to measure demographic characteristics and study outcomes: at baseline (before accessing the app) and after 6 months of using the app. Messages were downloaded from the peer-to-peer forum and subjected to manual content analysis. These data were used to train supervised ML algorithms using features extracted from the Linguistic Inquiry and Word Count (LIWC) system to automatically identify the types of expression relevant to peer-to-peer support. Regression analyses examined how each expression type was associated with recovery outcomes. Results: Our manual content analysis identified 7 expression types relevant to the recovery process (emotional support, informational support, negative affect, change talk, insightful disclosure, gratitude, and universality disclosure). Over 6 months of app use, 86.2% (231/268) of participants posted on the app’s support forum. Of these participants, 93.5% (216/231) posted at least 1 message in the content categories of interest, generating 10,503 messages. Supervised ML algorithms were trained on the hand-coded data, achieving F1-scores ranging from 0.57 to 0.85. Regression analyses revealed that a greater proportion of the messages giving emotional support to peers was related to reduced substance use. For self-disclosure, a greater proportion of the messages expressing universality was related to improved quality of life, whereas a greater proportion of the negative affect expressions was negatively related to quality of life and mood. Conclusions: This study highlights a method of natural language processing with potential to provide real-time insights into peer-to-peer communication dynamics. First, we found that our ML approach allowed for large-scale content coding while retaining moderate-to-high levels of accuracy. Second, individuals’ expression styles were associated with recovery outcomes. The expression types of emotional support, universality disclosure, and negative affect were significantly related to recovery outcomes, and attending to these dynamics may be important for appropriate intervention. %M 37606984 %R 10.2196/45589 %U https://www.jmir.org/2023/1/e45589 %U https://doi.org/10.2196/45589 %U http://www.ncbi.nlm.nih.gov/pubmed/37606984 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45223 %T Use of the Smoking Cessation App Ex-Smokers iCoach and Associations With Smoking-Related Outcomes Over Time in a Large Sample of European Smokers: Retrospective Observational Study %A Mansour,Marthe BL %A Busschers,Wim B %A Crone,Mathilde R %A van Asselt,Kristel M %A van Weert,Henk C %A Chavannes,Niels H %A Meijer,Eline %+ Department of General Practice, Academic Medical Centre Amsterdam, Amsterdam University Medical Centres, Meibergdreef 15, Amsterdam, 1105 AZ, Netherlands, 31 654273668, m.b.mansour@amsterdamumc.nl %K smoking cessation app %K digital smoking cessation intervention %K user groups %K trajectories of use patterns %K engagement %K smoking-related outcomes %K smoker characteristics %K European smokers %K mobile phone %D 2023 %7 22.8.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital interventions are increasingly used to support smoking cessation. Ex-smokers iCoach was a widely available app for smoking cessation used by 404,551 European smokers between June 15, 2011, and June 21, 2013. This provides a unique opportunity to investigate the uptake of a freely available digital smoking cessation intervention and its effects on smoking-related outcomes. Objective: We aimed to investigate whether there were distinct trajectories of iCoach use, examine which baseline characteristics were associated with user groups (based on the intensity of use), and assess if and how these groups were associated with smoking-related outcomes. Methods: Analyses were performed using data from iCoach users registered between June 15, 2011, and June 21, 2013. Smoking-related data were collected at baseline and every 3 months thereafter, with a maximum of 8 follow-ups. First, group-based modeling was applied to detect distinct trajectories of app use. This was performed in a subset of steady users who had completed at least 1 follow-up measurement. Second, ordinal logistic regression was used to assess the baseline characteristics that were associated with user group membership. Finally, generalized estimating equations were used to examine the association between the user groups and smoking status, quitting stage, and self-efficacy over time. Results: Of the 311,567 iCoach users, a subset of 26,785 (8.6%) steady iCoach users were identified and categorized into 4 distinct user groups: low (n=17,422, 65.04%), mild (n=4088, 15.26%), moderate (n=4415, 16.48%), and intensive (n=860, 3.21%) users. Older users and users who found it important to quit smoking had higher odds of more intensive app use, whereas men, employed users, heavy smokers, and users with higher self-efficacy scores had lower odds of more intensive app use. User groups were significantly associated with subsequent smoking status, quitting stage, and self-efficacy over time. For all groups, over time, the probability of being a smoker decreased, whereas the probability of being in an improved quitting stage increased, as did the self-efficacy to quit smoking. For all outcomes, the greatest change was observed between baseline and the first follow-up at 3 months. In the intensive user group, the greatest change was seen between baseline and the 9-month follow-up, with the observed change declining gradually in moderate, mild, and low users. Conclusions: In the subset of steady iCoach users, more intensive app use was associated with higher smoking cessation rates, increased quitting stage, and higher self-efficacy to quit smoking over time. These users seemed to benefit most from the app in the first 3 months of use. Women and older users were more likely to use the app more intensively. Additionally, users who found quitting difficult used the iCoach app more intensively and grew more confident in their ability to quit over time. %M 37606969 %R 10.2196/45223 %U https://www.jmir.org/2023/1/e45223 %U https://doi.org/10.2196/45223 %U http://www.ncbi.nlm.nih.gov/pubmed/37606969 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e46925 %T Long-Term Efficacy of Internet-Based Cognitive Behavioral Therapy Self-Help Programs for Adults With Depression: Systematic Review and Meta-Analysis of Randomized Controlled Trials %A Mamukashvili-Delau,Megi %A Koburger,Nicole %A Dietrich,Sandra %A Rummel-Kluge,Christine %+ Department of Psychiatry and Psychotherapy, Medical Faculty, Leipzig University, Klinik und Poliklinik für Psychiatrie und Psychotherapie Semmelweisstraße 10, Haus 13, Leipzig, 04103, Germany, 49 0341 97 24464, Christine.Rummel-Kluge@medizin.uni-leipzig.de %K depression %K internet-based cognitive behavioral therapy %K iCBT %K self-help %K minimal guidance %K long-term %K follow-up %K mental health %K psychotherapy %K cognitive behavioral therapy %K CBT %K systematic review %K meta-analysis %K meta-analyses %K review method %D 2023 %7 22.8.2023 %9 Review %J JMIR Ment Health %G English %X Background: Depression is a worldwide mental disorder and a leading cause of disability. Many people with depression do not want to take medication or have the motivation to seek psychotherapy treatment for many reasons. Guided internet-based self-help programs may be a promising solution for addressing these issues. This kind of intervention has proven to be effective in reducing depression symptoms on a short-term scale. However, as treatment often is a long-term rehabilitation process, it is important to examine not only the short-term effects of internet-based cognitive behavioral therapy (iCBT) self-help treatment but also the follow-up or long-term efficacy of this kind of intervention. Objective: This systematic review and meta-analysis aimed to identify studies that examined follow-up data ≥8 weeks after posttreatment measurements and thereby examined the long-term efficacy of iCBT self-help programs with minimal weekly guidance for people with depression. It aimed to analyze the long-term efficacy of iCBT treatments compared to control conditions as well as long-term efficacy within the iCBT treatment conditions. Additionally, it aimed to conduct subgroup analyses according to the follow-up time points for each outcome. Finally, it examined long-term improvements in quality of life. Methods: The Cochrane Collaboration Depression, Anxiety, and Neurosis Controlled Trials Register (CCDANCTR), grey literature, reference lists, and correspondence were used to search for published and unpublished randomized controlled trials (RCTs) that reported the long-term or follow-up efficacy of computer-based or iCBT self-help treatments for depression with minimal guidance of up to 10 min/wk. The search took place between 2015 and 2022 (October). Results: The search resulted in a total of 2809 study abstracts, of which 15 studies (with 17 samples) met all inclusion criteria and were included in the long-term analysis. The results showed that the depression outcomes of all follow-up time points together in the treatment conditions were favored over the control conditions with a medium effect size of 0.43 (n=1689 participants; 9 RCTs; standardized mean difference [SMD] –0.43, 95% CI –0.67 to –0.20; P<.001). The analysis of long-term efficacy within the iCBT treatment conditions showed that the follow-up outcomes of the treatment groups were favored over the posttreatment outcomes with a small effect size of 0.20 (n=2196 participants; 17 RCTs; SMD 0.20, 95% CI 0.07-0.49; P=.003). Findings for improving quality of life also showed that the iCBT conditions were favored over the control conditions with a small effect size of 0.19 (n=1345 participants; 3 RCTs; SMD 0.19, 95% CI 0.08-0.30; P<.001). Conclusions: This systematic review and meta-analysis found that iCBT self-help interventions had a superior long-term efficacy for individuals with depressive symptoms compared to control groups. The within-group analysis of iCBT treatment conditions also showed statistically significant improvements in reducing depressive symptoms at follow-up compared to posttreatment measurements. %M 37606990 %R 10.2196/46925 %U https://mental.jmir.org/2023/1/e46925 %U https://doi.org/10.2196/46925 %U http://www.ncbi.nlm.nih.gov/pubmed/37606990 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 6 %N %P e46480 %T A Tablet-Based App to Support Nursing Home Staff in Delivering an Individualized Cognitive and Physical Exercise Program for Individuals With Dementia: Mixed Methods Usability Study %A Krafft,Jelena %A Barisch-Fritz,Bettina %A Krell-Roesch,Janina %A Trautwein,Sandra %A Scharpf,Andrea %A Woll,Alexander %+ Institute of Sports and Sports Science, Karlsruhe Institute of Technology, Engler-Bunte-Ring 15, Karlsruhe, 76131, Germany, 49 721 608 ext 48513, jelena.krafft@kit.edu %K dementia %K individualized physical exercise %K tailored exercise %K physical activity %K older adults %K app %K mobile health %K mHealth %K usability %K mobile phone %D 2023 %7 22.8.2023 %9 Original Paper %J JMIR Aging %G English %X Background: The promotion of physical activity in individuals with dementia living in nursing homes is crucial for preserving physical and cognitive functions and the associated quality of life. Nevertheless, the implementation of physical activity programs in this setting is challenging, as the time and expertise of nursing home staff are limited. This situation was further exacerbated by the COVID-19 pandemic. Mobile health apps may be a sustainable approach to overcome these challenges in the long term. Therefore, the Individualized Cognitive and Physical Exercise-App (the InCoPE-App) was developed to support nursing home staff in delivering and implementing tailored cognitive and physical exercise training for individuals with dementia. Objective: This study aims to assess the usability of the InCoPE-App in terms of user performance and user perception in a laboratory setting using a mixed methods approach. Methods: Nursing home staff were encouraged to perform 5 basic tasks within the InCoPE-App. Their thoughts while using the app were captured by implementing a think aloud protocol. Then, participants completed the System Usability Scale questionnaire. The think aloud transcripts were qualitatively evaluated to unveil usability issues. All identified issues were rated in terms of their necessity to be fixed. Task completion (ie, success rate and time) and perceived usability were evaluated descriptively. Results: A total of 14 nursing home employees (mean age 53.7, SD 10.6 years; n=13, 93% women) participated in the study. The perceived usability of the InCoPE-App, as assessed by the System Usability Scale questionnaire, can be rated as “good.” The main usability issues concerned navigation logic and comprehensibility of app content. Conclusions: The InCoPE-App is a user-friendly app that enables nursing home staff to deliver and implement cognitive and physical exercise training for individuals with dementia in nursing homes. The InCoPE-App can be used with little training, even by people aged ≥50 years, who may have low digital literacy. To achieve sustainable use and high user satisfaction of the InCoPE-App in the long term, it should be implemented and evaluated in a field study. %M 37606974 %R 10.2196/46480 %U https://aging.jmir.org/2023/1/e46480 %U https://doi.org/10.2196/46480 %U http://www.ncbi.nlm.nih.gov/pubmed/37606974 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e42561 %T Qualitative Evaluation of Family Caregivers’ Experiences Participating in Knowledge and Interpersonal Skills to Develop Exemplary Relationships (KINDER): Web-Based Intervention to Improve Relationship Quality %A Meyer,Kylie %A Gonzalez,Alexander %A Benton,Donna %+ Frances Payne Bolton School of Nursing, Case Western Reserve University, 10900 Euclid Avenue, Cleveland, OH, 44106, United States, 1 216 368 1928, knm77@case.edu %K aging %K Alzheimer’s %K Alzheimer %K caregiver %K caregiving %K dementia: digital health %K digital intervention %K family care %K informal care %K intervention %K older adult %K quality of care %D 2023 %7 22.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The onset of Alzheimer disease and related dementias (AD/ADRD) can alter relationships between family caregivers and persons living with AD/ADRD, such as through the occurrence of distressful behavioral and psychological symptoms of dementia. Poorly perceived relationship quality by caregivers contributes to negative outcomes for both care partners, such as low-quality caregiving and potential mistreatment of older adults. Knowledge and Interpersonal Skills to Develop Exemplary Relationships (KINDER) is a new, web-based, asynchronous psychoeducational intervention with content informed by focus groups with family caregivers. The program was developed to prevent low-quality caregiving and potential mistreatment of older adults by focusing on building healthy caregiving relationships. Objective: The purpose of this study is to describe caregivers’ experiences participating in KINDER to understand intervention acceptability. Of particular interest was learning how comfortable caregivers were viewing content addressing potential mistreatment, as well as whether asynchronous delivery created any barriers to participating in the intervention. Findings will inform future program refinements before efficacy testing. Methods: Although 23 caregivers enrolled in the KINDER parent study, only 7 of them completed the 8-week intervention. In-depth, semistructured qualitative interviews were conducted with all participants who completed the program to understand their experiences while attending KINDER and to decipher barriers to participation. We also asked participants about which program elements were most valuable and which were least valuable to them, as well as how the program could be improved. Interview transcripts were analyzed by 2 coders using thematic analysis. Results: Our findings indicate that caregivers were overall satisfied with KINDER’s focus and content. Participants particularly liked how KINDER materials felt authentic and relevant to supporting healthy care relationships (Theme 1). The program’s multiple components were found to be valuable, especially story-based video vignettes and readings (Theme 2). Most caregivers were comfortable viewing depictions of mistreatment and understood the importance of this content (Theme 3). Notably, while caregivers appreciated the convenience of participating in an asynchronous web-based intervention, several expressed a desire for more opportunities to speak with other caregivers (Theme 4). Technology challenges, such as a lack of clarity about automated intervention activities, deterred completion. Conclusions: Findings from this study suggest an asynchronous web-based intervention covering sensitive topics such as mistreatment is acceptable for at least some AD/ADRD caregivers. Caregivers’ comments that materials felt authentic may suggest that the integration of caregiver voices before intervention development enhanced the relevance of content. To make KINDER easier to deliver and participate in, the investigators plan to reduce the use of automation and integrate more group-based programming, as recommended by participants. Further, given the higher-than-expected dropout rate, in future studies, the investigators will collect data to determine the reasons for participants not completing study activities. %M 37606980 %R 10.2196/42561 %U https://formative.jmir.org/2023/1/e42561 %U https://doi.org/10.2196/42561 %U http://www.ncbi.nlm.nih.gov/pubmed/37606980 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42647 %T Key Factors in Helpfulness and Use of the SAFE Intervention for Women Experiencing Intimate Partner Violence and Abuse: Qualitative Outcomes From a Randomized Controlled Trial and Process Evaluation %A van Gelder,Nicole E %A Ligthart,Suzanne A %A van Rosmalen-Nooijens,Karin A W L %A Prins,Judith B %A Oertelt-Prigione,Sabine %+ Department of Primary and Community Care, Research Institute for Medical Innovation, Radboud University Medical Center, Geert Grooteplein Noord 21, Nijmegen, 6525 EZ, Netherlands, 31 243618181, nicole.vangelder@radboudumc.nl %K intimate partner violence and abuse %K domestic violence and abuse %K eHealth %K web based %K web-based intervention %K help seeking %K interview %K qualitative %K randomized controlled trial %K process evaluation %D 2023 %7 21.8.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Many women experience at least one type of intimate partner violence and abuse (IPVA), and although various support options are available, we still know relatively little about web-based interventions for IPVA survivors. We conducted a qualitative evaluation of the SAFE eHealth intervention for women experiencing IPVA in the Netherlands, complementing the quantitative evaluation of self-efficacy, depression, anxiety, and multiple feasibility aspects. Objective: This study assessed users’ experiences and what, according to them, were useful and helpful aspects of the intervention. Methods: The intervention consisted of modules with information on relationships and IPVA, help options, physical and mental health, and social support. It also contained interactive elements such as exercises, stories from survivors, a chat, and a forum. A randomized controlled trial was conducted with an intervention arm receiving the complete version of the intervention and a control arm receiving only a static version with the modules on relationships and IPVA and help options. We gathered data through open questions from surveys (for both study arms; n=65) and semistructured interviews (for the intervention study arm; n=10), all conducted on the web, during the randomized controlled trial and process evaluation. Interview data were coded following the principles of open thematic coding, and all qualitative data were analyzed using qualitative content analysis. Results: Overall, most users positively rated the intervention regarding safety, content, and suiting their needs, especially participants from the intervention study arm. The intervention was helpful in the domains of acknowledgment, awareness, and support. However, participants also identified points for improvement: the availability of a simplified version for acute situations; more attention for survivors in the aftermath of ending an abusive relationship; and more information on certain topics, such as technological IPVA, support for children, and legal affairs. Furthermore, although participants expressed a prominent need for interactive contact options such as a chat or forum, the intervention study arm (the only group that had these features at their disposal) mainly used them in a passive way—reading instead of actively joining the conversation. The participants provided various reasons for this passive use. Conclusions: The positive outcomes of this study are similar to those of other web-based interventions for IPVA survivors, and specific points for improvement were identified. The availability of interactive elements seems to be of added value even when they are used passively. This study provides in-depth insight into the experiences of female IPVA survivors with the SAFE eHealth intervention and makes suggestions for improvements to SAFE and comparable web-based interventions for IPVA as well as inspiring future research. Furthermore, this study shows the importance of a varied assessment of an intervention’s effectiveness to understand the real-world impact on its users. Trial Registration: Netherlands Trial Register NTR7313; https://tinyurl.com/3t7vwswz %M 37603391 %R 10.2196/42647 %U https://www.jmir.org/2023/1/e42647 %U https://doi.org/10.2196/42647 %U http://www.ncbi.nlm.nih.gov/pubmed/37603391 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e49236 %T Comparing Digital to Conventional Physical Therapy for Chronic Shoulder Pain: Randomized Controlled Trial %A Pak,Sang S %A Janela,Dora %A Freitas,Nina %A Costa,Fabíola %A Moulder,Robert %A Molinos,Maria %A Areias,Anabela C %A Bento,Virgílio %A Cohen,Steven P %A Yanamadala,Vijay %A Souza,Richard B %A Correia,Fernando Dias %+ Department of Physical Therapy and Rehabilitation, University of California San Francisco, 1500 Owens St Suite 400, San Francisco, CA, 94158, United States, 1 415 514 6779, sam.pak@ucsf.edu %K chronic shoulder %K clinical outcome %K digital care %K digital health intervention %K musculoskeletal pain %K pain management %K physical therapy %K remote sensing technology %K telerehabilitation %D 2023 %7 18.8.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic shoulder pain (CSP) is a common condition with various etiologies, including rotator cuff disorders, adhesive capsulitis, shoulder instability, and shoulder arthritis. It is associated with substantial disability and psychological distress, resulting in poor productivity and quality of life. Physical therapy constitutes the mainstay treatment for CSP, but several barriers exist in accessing care. In recent years, telerehabilitation has gained momentum as a potential solution to overcome such barriers. It has shown numerous benefits, including improving access and convenience, promoting patient adherence, and reducing costs. However, to date, no previous randomized controlled trial has compared fully remote digital physical therapy to in-person rehabilitation for nonoperative CSP. Objective: The aim of this study is to compare clinical outcomes between digital physical therapy and conventional in-person physical therapy in patients with CSP. Methods: We conducted a single-center, parallel-group, randomized controlled trial involving 82 patients with CSP referred for outpatient physical therapy. Participants were randomized into digital or conventional physical therapy (8-week interventions). The digital intervention consisted of home exercise, education, and cognitive behavioral therapy (CBT), using a device with movement digitalization for biofeedback and asynchronous physical therapist monitoring through a cloud-based portal. The conventional group received in-person physical therapy, including exercises, manual therapy, education, and CBT. The primary outcome was the change (baseline to 8 weeks) in function and symptoms using the short-form of Disabilities of the Arm, Shoulder, and Hand questionnaire. Secondary outcome measures included self-reported pain, surgery intent, analgesic intake, mental health, engagement, and satisfaction. All questionnaires were delivered electronically. Results: A total of 90 participants were randomized into digital or conventional physical therapy, with 82 receiving the allocated intervention. Both groups experienced significant improvements in function measured by the short-form of the Disabilities of the Arm, Shoulder, and Hand questionnaire, with no differences between groups (–1.8, 95% CI –13.5 to 9.8; P=.75). For secondary outcomes, no differences were observed in surgery intent, analgesic intake, and mental health or worst pain. Higher reductions were observed in average and least pain in the conventional group, which, given the small effect sizes (least pain 0.15 and average pain 0.16), are unlikely to be clinically meaningful. High adherence and satisfaction were observed in both groups, with no adverse events. Conclusions: This study shows that fully remote digital programs can be viable care delivery models for CSP given their scalability and effectiveness, assessed through comparison with high-dosage in-person rehabilitation. Trial Registration: ClinicalTrials.gov (NCT04636528); https://clinicaltrials.gov/study/NCT04636528 %M 37490337 %R 10.2196/49236 %U https://www.jmir.org/2023/1/e49236 %U https://doi.org/10.2196/49236 %U http://www.ncbi.nlm.nih.gov/pubmed/37490337 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e44679 %T Health Economic Evaluation of Cognitive Control Training for Depression: Key Considerations %A Nève de Mévergnies,Constance %A Verhaeghe,Nick %A Koster,Ernst H W %A Baeken,Chris %A Vander Zwalmen,Yannick %A Hoorelbeke,Kristof %+ Department of Experimental Clinical and Health Psychology, Ghent University, Henri Dunantlaan 2, Ghent, 9000, Belgium, 32 9 264 64 74, kristof.hoorelbeke@Ugent.be %K health economic evaluation %K cost utility %K cognitive control training %K CCT %K depression recurrence %K health policies %D 2023 %7 18.8.2023 %9 Viewpoint %J JMIR Ment Health %G English %X Depression is a serious and burdensome psychiatric illness that contributes heavily to health expenditures. These costs are partly related to the observation that depression is often not limited to a single episode but can recur or follow a chronic pathway. In terms of risk factors, it is acknowledged that cognitive impairments play a crucial role in vulnerability to depression. Within this context, cognitive control training (CCT) has shown its effectiveness in reducing the risk for recurrence of depression. CCT is low cost intensive and can be provided as a web-based intervention, which makes it easy to disseminate. Despite increasing interest in the field, studies examining the cost-effectiveness of CCT in the context of depression are largely missing. Health economic evaluation (HEE) allows to inform decision makers with evidence-based insights about how to spend limited available (financial) resources in the most efficient way. HEE studies constitute a crucial step in the implementation of a new intervention in clinical practice. Approaching preventive measures for depression such as CCT from an HEE perspective is informative to health policy, fostering optimal use of health expenditures. The aim of this paper was to inform and guide researchers during the phase of designing HEE studies in the context of CCT for depression. A clear view of CCT’s cost-effectiveness is paramount for its clinical implementation. %M 37594847 %R 10.2196/44679 %U https://mental.jmir.org/2023/1/e44679 %U https://doi.org/10.2196/44679 %U http://www.ncbi.nlm.nih.gov/pubmed/37594847 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44924 %T Understanding Attrition in Text-Based Health Promotion for Fathers: Survival Analysis %A Fletcher,Richard %A Regan,Casey %A Dizon,Jason %A Leigh,Lucy %+ School of Health Sciences, College of Health, Medicine, and Wellbeing, The University of Newcastle, University Drive, Callaghan, 2308, Australia, 61 429 152 405, richard.fletcher@newcastle.edu.au %K attrition %K dropout %K text-based program %K parenting %K fathers %D 2023 %7 18.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Web-based interventions targeting parents with health and parenting support frequently report high rates of attrition. The SMS4dads text messaging program, developed in Australia, has delivered texts to over 10,000 fathers. The brief text messages, which are sent 3 times per week from 16 weeks of gestation to 48 weeks after birth, include regular reminders that participants can leave the program by texting back “STOP” to any message. Although acceptance of the program is high, almost 1 in 5 ask it to be removed. Analyzing the factors influencing attrition from digital parenting programs such as SMS4dads may assist in developing more effective interventions. Objective: This study aimed to examine factors associated with attrition in a text-based intervention targeting fathers. Methods: Demographic characteristics, requests to complete a psychological scale, individual message content, participant feedback, and automatically collected data registering clicks on links embedded in the texts were examined to identify attrition factors among 3261 participants enrolled in SMS4dads from 4 local health districts in New South Wales, Australia, between September 2020 and December 2021. Results: Participants who were smokers, recorded risky alcohol consumption, had a lower education level, or signed up prenatally had 30% to 47% higher hazard of dropout from the program, whereas participant age, Aboriginal or Torres Strait Islander status, rurality, and psychological distress score (as Kessler Psychological Distress Scale [K10] category) were not associated with dropout. Primary reasons for dropping out reported by 202 of 605 respondents included “other reasons” (83/202, 41.1%), followed by “not helpful” (47/202, 23.3%) and “too busy” (44/202, 21.8%). Program features such as repeated requests to complete a psychological scale (K10) and the content of individual messages were not linked to increased dropout rates. Analysis of a sample (216/2612) of inactive participants who had not engaged (clicked on any embedded links) for at least 10 weeks but who had not opted out identified a further 1.5% of participants who would opt to leave the program if asked. Conclusions: Identifying which features of the participant population and of the program are linked to dropout rates can provide guidance for improving program adherence. However, with limited information from feedback surveys of those exiting early, knowing which features to target does not, by itself, suggest ways to increase engagement. Planning ahead to include robust measures of attrition, including more detailed feedback from participants, could provide more effective guidance. A novel element in this study was seeking feedback from inactive participants to estimate dropout from this group and thereby provide an overall dropout rate of 20%. The retention rate of 80%, relatively high compared with other web-based parenting programs for fathers, suggests that tailoring the content to specifically address fathers’ role may be an important consideration in reducing fathers’ disengagement. %M 37594788 %R 10.2196/44924 %U https://formative.jmir.org/2023/1/e44924 %U https://doi.org/10.2196/44924 %U http://www.ncbi.nlm.nih.gov/pubmed/37594788 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49670 %T Strengthening Mental Health and Resilience Through Schools: Protocol for a Participatory Design Project %A Kegelaers,Jolan %A Baetens,Imke %A Soyez,Veerle %A Van Heel,Martijn %A Van Hove,Lisa %A Wylleman,Paul %+ Brussels University Consultation Center, Faculty of Psychology and Educational Sciences, Vrije Universiteit Brussel, Pleinlaan 2, Brussels, 1050, Belgium, 32 2 629 27 60, jolan.kegelaers@vub.be %K children %K physical activity %K psychological symptoms %K sport %K well-being %K youth %D 2023 %7 18.8.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Mental health problems are a main contributor to the global burden of disease in children and young people within urban environments. In response, the potential of both school- and sport-based mental health promotion interventions has been advocated. However, there exists limited insights into how sport-based interventions can be integrated within school environment. Moreover, there is a need to consider children and young people’s specific needs, challenges, and motivations when designing novel mental health promotion interventions. Objective: The Strengthening Mental Health and Resilience Through Schools (SMARTS) project aims to co-design an evidence-informed school-sport-based mental health promotion program. Specific objectives include (1) co-designing a multicomponent program, integrating sport sessions with class-based sessions, and complementing with educational modules for teachers and parents; (2) exploring how the mental health program can be implemented most effectively within the Brussels school system; and (3) conducting preliminary process and outcome testing of the program. Methods: A participatory design framework will be adopted to develop the program. This framework involves end users throughout the entire study process, from problem identification to intervention delivery and evaluation, while at the same time ensuring program development remains directly informed by the available scientific evidence. Results: Participant recruitment will commence in September 2023. The full project will be completed by March 2027. Conclusions: With this intervention, we aim to provide a direct contribution to the promotion of children and young people’s mental health within the Brussels school context. At a broader level, conducting and documenting this large participatory design project can, hopefully, inspire other researchers to tailor their mental health programs to specific populations. International Registered Report Identifier (IRRID): PRR1-10.2196/49670 %M 37594846 %R 10.2196/49670 %U https://www.researchprotocols.org/2023/1/e49670 %U https://doi.org/10.2196/49670 %U http://www.ncbi.nlm.nih.gov/pubmed/37594846 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e47436 %T Design and Early Use of the Nationally Implemented Healthier You National Health Service Digital Diabetes Prevention Programme: Mixed Methods Study %A Ross,Jamie %A Hawkes,Rhiannon E %A Miles,Lisa M %A Cotterill,Sarah %A Bower,Peter %A Murray,Elizabeth %+ Centre for Primary Care, Wolfson Institute of Population Health Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, United Kingdom, 44 02080168037, jamie.ross@qmul.ac.uk %K digital health %K engagement %K diabetes prevention %K mobile phone %D 2023 %7 17.8.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: The Healthier You National Health Service Digital Diabetes Prevention Programme (NHS-digital-DPP) is a 9-month digital behavior change intervention delivered by 4 independent providers that is implemented nationally across England. No studies have explored the design features included by service providers of digital diabetes prevention programs to promote engagement, and little is known about how participants of nationally implemented digital diabetes prevention programs such as this one make use of them. Objective: This study aimed to understand engagement with the NHS-digital-DPP. The specific objectives were to describe how engagement with the NHS-digital-DPP is promoted via design features and strategies and describe participants’ early engagement with the NHS-digital-DPP apps. Methods: Mixed methods were used. The qualitative study was a secondary analysis of documents detailing the NHS-digital-DPP intervention design and interviews with program developers (n=6). Data were deductively coded according to an established framework of engagement with digital health interventions. For the quantitative study, anonymous use data collected over 9 months for each provider representing participants’ first 30 days of use of the apps were obtained for participants enrolled in the NHS-digital-DPP. Use data fields were categorized into 4 intervention features (Track, Learn, Coach Interactions, and Peer Support). The amount of engagement with the intervention features was calculated for the entire cohort, and the differences between providers were explored statistically. Results: Data were available for 12,857 participants who enrolled in the NHS-digital-DPP during the data collection phase. Overall, 94.37% (12,133/12,857) of those enrolled engaged with the apps in the first 30 days. The median (IQR) number of days of use was 11 (2-25). Track features were engaged with the most (number of tracking events: median 46, IQR 3-22), and Peer Support features were the least engaged with, a median value of 0 (IQR 0-0). Differences in engagement with features were observed across providers. Qualitative findings offer explanations for the variations, including suggesting the importance of health coaches, reminders, and regular content updates to facilitate early engagement. Conclusions: Almost all participants in the NHS-digital-DPP started using the apps. Differences across providers identified by the mixed methods analysis provide the opportunity to identify features that are important for engagement with digital health interventions and could inform the design of other digital behavior change interventions. %M 37590056 %R 10.2196/47436 %U https://www.jmir.org/2023/1/e47436 %U https://doi.org/10.2196/47436 %U http://www.ncbi.nlm.nih.gov/pubmed/37590056 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45407 %T Exploring the Effect of the Dynamics of Behavioral Phenotypes on Health Outcomes in an mHealth Intervention for Childhood Obesity: Longitudinal Observational Study %A Woo,Sarah %A Jung,Sunho %A Lim,Hyunjung %A Kim,YoonMyung %A Park,Kyung Hee %+ Department of Family Medicine, Hallym University Sacred Heart Hospital, Hallym University, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14068, Republic of Korea, 82 31 380 3805, beloved920@gmail.com %K behavioral dynamics %K behavioral phenotype %K functional data analysis %K FDA %K machine learning analysis %K mobile health %K mHealth %K obesity intervention %K pediatric obesity %K mobile phone %D 2023 %7 17.8.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Advancements in mobile health technologies and machine learning approaches have expanded the framework of behavioral phenotypes in obesity treatment to explore the dynamics of temporal changes. Objective: This study aimed to investigate the dynamics of behavioral changes during obesity intervention and identify behavioral phenotypes associated with weight change using a hybrid machine learning approach. Methods: In total, 88 children and adolescents (ages 8-16 years; 62/88, 71% male) with age- and sex-specific BMI ≥85th percentile participated in the study. Behavioral phenotypes were identified using a hybrid 2-stage procedure based on the temporal dynamics of adherence to the 5 behavioral goals during the intervention. Functional principal component analysis was used to determine behavioral phenotypes by extracting principal component factors from the functional data of each participant. Elastic net regression was used to investigate the association between behavioral phenotypes and weight change. Results: Functional principal component analysis identified 2 distinctive behavioral phenotypes, which were named the high or low adherence level and late or early behavior change. The first phenotype explained 47% to 69% of each factor, whereas the second phenotype explained 11% to 17% of the total behavioral dynamics. High or low adherence level was associated with weight change for adherence to screen time (β=−.0766, 95% CI −.1245 to −.0312), fruit and vegetable intake (β=.1770, 95% CI .0642-.2561), exercise (β=−.0711, 95% CI −.0892 to −.0363), drinking water (β=−.0203, 95% CI −.0218 to −.0123), and sleep duration. Late or early behavioral changes were significantly associated with weight loss for changes in screen time (β=.0440, 95% CI .0186-.0550), fruit and vegetable intake (β=−.1177, 95% CI −.1441 to −.0680), and sleep duration (β=−.0991, 95% CI −.1254 to −.0597). Conclusions: Overall level of adherence, or the high or low adherence level, and a gradual improvement or deterioration in health-related behaviors, or the late or early behavior change, were differently associated with weight loss for distinctive obesity-related lifestyle behaviors. A large proportion of health-related behaviors remained stable throughout the intervention, which indicates that health care professionals should closely monitor changes made during the early stages of the intervention. Trial Registration: Clinical Research Information Science KCT0004137; https://tinyurl.com/ytxr83ay %M 37590040 %R 10.2196/45407 %U https://www.jmir.org/2023/1/e45407 %U https://doi.org/10.2196/45407 %U http://www.ncbi.nlm.nih.gov/pubmed/37590040 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45362 %T The Overall Anxiety Severity and Impairment Scale as an Outcome Measure in Internet-Delivered Cognitive Behavioral Therapy for Anxiety Disorders: Observational Study %A Karpov,Boris %A Lipsanen,Jari Olavi %A Ritola,Ville %A Rosenström,Tom %A Saarni,Suoma %A Pihlaja,Satu %A Stenberg,Jan-Henry %A Laizane,Paula %A Joffe,Grigori %+ Department of Psychiatry, Helsinki University Hospital, Välskärinkatu 12, Helsinki, 00260, Finland, 358 401854948, boris.karpov@hus.fi %K Overall Anxiety Severity and Impairment Scale %K OASIS %K internet-delivered cognitive behavioral therapy %K iCBT %K anxiety %K social anxiety disorder %K panic disorder %K obsessive-compulsive disorder %K OCD %D 2023 %7 17.8.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-delivered cognitive behavioral therapy (iCBT) is effective in the treatment of anxiety disorders. iCBT clinical trials use relatively long and time-consuming disorder-specific rather than transdiagnostic anxiety measurements. Overall Anxiety Severity and Impairment Scale (OASIS) is a brief self-report scale that could offer a universal, easy-to-use anxiety measurement option in disorder-specific and transdiagnostic iCBT programs. Objective: We aimed to investigate relationships between OASIS and disorder-specific instruments in iCBT. We expected these relationships to be positive. Methods: We investigated patients in original nationwide iCBT programs for generalized anxiety disorder (GAD), obsessive-compulsive disorder, panic disorder, and social anxiety disorder, which were administered by Helsinki University Hospital, Finland. In each program, anxiety symptoms were measured using both disorder-specific scales (the 7-item Generalized Anxiety Disorder scale, Penn State Worry Questionnaire, revised Obsessive-Compulsive Inventory, Panic Disorder Severity Scale, and Social Phobia Inventory) and by OASIS. A general linear model for repeated measures (mixed models) and interaction analysis were used for investigating the changes and relationships in the mean scores of OASIS and disorder-specific scales from the first session to the last one. Results: The main effect of linear mixed models indicated a distinct positive association between OASIS and disorder-specific scale scores. Interaction analysis demonstrated relatively stable associations between OASIS and the revised Obsessive-Compulsive Inventory (F822.9=0.09; 95% CI 0.090-0.277; P=.32), and OASIS and the Panic Disorder Severity Scale (F596.6=–0.02; 95% CI –0.108 to –0.065; P=.63) from first the session to the last one, while the 7-item Generalized Anxiety Disorder scale (F4345.8=–0.06; 95% CI –0.109 to –0.017; P=.007), Penn State Worry Questionnaire (F4270.8=–0.52; 95% CI –0.620 to –0.437; P<.001), and Social Phobia Inventory (F862.1=–0.39; 95% CI –0.596 to –0.187; P<.001) interrelated with OASIS more strongly at the last session than at the first one. Conclusions: OASIS demonstrates clear and relatively stable associations with disorder-specific symptom measures. Thus, OASIS might serve as an outcome measurement instrument for disorder-specific and plausibly transdiagnostic iCBT programs for anxiety disorders in regular clinical practice. %M 37590055 %R 10.2196/45362 %U https://www.jmir.org/2023/1/e45362 %U https://doi.org/10.2196/45362 %U http://www.ncbi.nlm.nih.gov/pubmed/37590055 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46326 %T Effectiveness of an Internet-Based Self-Guided Program to Treat Depression in a Sample of Brazilian Users: Randomized Controlled Trial %A Lopes,Rodrigo T %A da Rocha,Gustavo Chapetta %A Svacina,Maria Adriana %A Meyer,Björn %A Šipka,Dajana %A Berger,Thomas %+ University of Bern, Fabrikstrasse, 8, Clinical Psychology and Psychotherapy Department, Bern, 3012, Switzerland, 41 0787574701, rodrigo.lopes@psy.unibe.ch %K depression %K internet-based interventions %K self-guided interventions %K cognitive behavioral therapy %D 2023 %7 17.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Depression is undertreated in Brazil. Deprexis is a self-guided internet-based program used to treat depressive symptoms based on empirically supported integrative and cognitive behavioral therapy. Evidence from a meta-analysis supports Deprexis’ efficacy in German-speaking countries and the United States, but no study has been conducted using this program in countries with low literacy rates and large social disparities. Furthermore, few studies have investigated whether internet-based interventions ameliorate the psychological processes that might underlie depressive symptomatology, such as low perceived self-efficacy. Objective: The main objective of this study was to replicate in Brazil previously reported effects of Deprexis on depressive symptom reduction. Therefore, the main research question was whether Deprexis is effective in reducing depressive symptoms and the general psychological state in Brazilian users with moderate and severe depression in comparison with a control group that does not receive access to Deprexis. A secondary research question was whether the use of Deprexis affects perceptions of self-efficacy. Methods: We interviewed 312 participants recruited over the internet and randomized 189 participants with moderate to severe depression (according to the Patient Health Questionnaire–9 and a semistructured interview) to an intervention condition (treatment as usual plus immediate access to Deprexis for 90 days, n=94) or to a control condition (treatment as usual and delayed access to Deprexis, after 8 weeks, n=95). Results: Participants from the immediate access group logged in at Deprexis an average of 14.81 (SD 12.16) times. The intention-to-treat analysis using a linear mixed model showed that participants who received Deprexis improved significantly more than participants assigned to the delayed access control group on the primary depression self-assessment measure (Patient Health Questionnaire–9; Cohen d=0.80; P<.001) and secondary outcomes, such as general psychological state measure (Clinical Outcome in Routine Evaluation–Outcome Measurement; Cohen d=0.82; P<.001) and the perceived self-efficacy measure (Cohen d=0.63; P<.001). The intention-to-treat analyses showed that 21% (20/94) of the participants achieved remission compared with 7% (7/95) in the control group (P<.001). The deterioration rates were lower in the immediate access control group. The dropout rate was high, but no differences in demographic and clinical variables were found. Participants reported a medium to high level of satisfaction with Deprexis. Conclusions: These results replicate previous findings by showing that Deprexis can facilitate symptomatic improvement over 3 months in depressed samples of Brazilian users. From a public health perspective, this is important information to expand the reach of internet-based interventions for those who really need them, especially in countries with less access to mental health care. This extends previous research by showing significant effects on perceived self-efficacy. Trial Registration: Registro Brasileiro de Ensaios Clíncos (ReBec) RBR-6kk3bx UTN U1111-1212-8998; https://ensaiosclinicos.gov.br/rg/RBR-6kk3bx/ International Registered Report Identifier (IRRID): RR2-10.1590/1516-4446-2019-0582 %M 37590052 %R 10.2196/46326 %U https://formative.jmir.org/2023/1/e46326 %U https://doi.org/10.2196/46326 %U http://www.ncbi.nlm.nih.gov/pubmed/37590052 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45717 %T Stimulant Use Associated With Psychosocial Factors, HIV Risk, and Concurrent Hazardous Alcohol Use Among US Adults: Exploratory Cross-Sectional Questionnaire Study %A Lee,Frank %A Jain,Jennifer Payaal %A Duthely,Lunthita M %A Ikeda,Janet %A Santos,Glenn-Milo %+ Center on Substance Use and Health, San Francisco Department of Public Health, 25 Van Ness Ave, San Francisco, CA, 94102, United States, 1 8587361717, franklee@berkeley.edu %K Amazon Mechanical Turk %K stimulant use %K alcohol use %K craving %K men who have sex with men %K MSM %K depression %K affect %K HIV %K public health %K gender minority %K psychosocial %K addiction %D 2023 %7 17.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Stimulant use is a major public health problem that contributes to morbidity and mortality among men who have sex with men (MSM) in the United States. To reduce the harms associated with stimulant use, there is a need to identify the factors associated with stimulant use to inform interventions. Additionally, there is a need to use large crowdsourcing platforms like Amazon Mechanical Turk (MTurk) to engage more individuals who use substances across the United States. Objective: We identified the correlates of stimulant use among people who use alcohol or stimulants in the United States recruited using MTurk. Methods: Participants who were aged ≥18 years in the United States and reported alcohol or stimulant (ie, cocaine, crack cocaine, and methamphetamine) use were deemed eligible and recruited via the web platform MTurk. Participants completed a baseline survey, which assessed sociodemographics, psychosocial (ie, depression, affect, self-esteem, and stress) factors, substance use, and sexual behaviors. Data were collected and analyzed with STATA (version 17; StataCorp). Stratifying by MSM status, bivariate and multivariable logistic regression models were built in STATA to examine the correlates of stimulant use. Multivariable models controlled for age, race, health insurance, and relationship status. Results: Of 272 participants, 201 (73.9%) identified as male, 134 (49.2%) were MSM, 52 (19.1%) were from racial and ethnic minoritized communities, and 158 (58%) were in a relationship. The mean age was 36.10 (SD 10.3) years. A total of 40 (14.7%) participants reported stimulant use in the past 6 months. Factors significantly associated with stimulant use were being MSM (adjusted odds ratio [aOR] 4.61, 95% CI 1.97-10.81), a higher Alcohol Use Disorders Identification Test-Concise score (aOR 1.24, 95% CI 1.08-1.42), more intense cravings for alcohol in the past 24 hours (aOR 1.03, 95% CI 1.01-1.04), a higher depression score (aOR 1.06, 95% CI 1.01-1.12), a greater number of male partners in the last 6 months (aOR 1.32, 95% CI 1.08-1.61), a greater number of female partners in the last 6 months (aOR 1.42, 95% CI 1.04-1.92), and being diagnosed with a sexually transmitted infection (eg, syphilis, gonorrhea, chlamydia, herpes simplex virus, human papillomavirus, and other) in the last 6 months (aOR 14.61, 95% CI 3.45-61.87). Additionally, there was a significant additive interaction between MSM status and negative affect, such that the impact of negative affect on stimulant use was significantly greater among MSM compared with non-MSM (relative excess risk due to interaction 0.085, 95% CI 0.037-0.13). Conclusions: Interventions that address stimulant use should use evidence-based approaches that reduce negative affect, depression, and cravings for alcohol. Additionally, interventions should be customized for MSM populations. %M 37590045 %R 10.2196/45717 %U https://formative.jmir.org/2023/1/e45717 %U https://doi.org/10.2196/45717 %U http://www.ncbi.nlm.nih.gov/pubmed/37590045 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e49284 %T A Digital Music-Based Mindfulness Intervention for Black Americans With Elevated Race-Based Anxiety: A Multiple-Baseline Pilot Study %A Jones,Grant %A Herrmann,Felipe %A Nock,Matthew K %+ Harvard University, 33 Kirkland Street, Cambridge, MA, 02138, United States, gmj005@g.harvard.edu %K Black music %K mindfulness %K meditation %K single-case experiment %K race %K anxiety %K mindfulness %K digital health intervention %K low income %K Black community %K racial disparity %D 2023 %7 16.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Race-based anxiety is a substantial health issue for the Black community. Although mindfulness interventions have demonstrated efficacy for alleviating anxiety, three central barriers prevent Black Americans from accessing existing mindfulness treatments: high costs, excessive time commitments, and limited cultural relevance. There is a need for novel mindfulness interventions for the Black community that can overcome these barriers. Objective: The goal of this web-based study was to examine the preliminary efficacy, feasibility, and acceptability of a novel digital music-based mindfulness intervention for middle-to-low-income Black Americans with elevated race-based anxiety. Methods: This study used a nonconcurrent multiple-baseline design (n=5). The intervention featured contributions from Lama Rod Owens (a world-renowned meditation teacher and LA Times best-selling author) and Terry Edmonds (the former chief speechwriter for President Bill Clinton). We examined the effect of the intervention on state anxiety and assessed its feasibility and acceptability using quantitative and qualitative measures. Results: Results revealed that administration of the intervention led to significant decreases in state anxiety (Tau-U range –0.75 to –0.38; P values<.001). Virtually all feasibility and acceptability metrics were high (ie, the average likelihood of recommending the intervention was 98 out of 100). Conclusions: This study offers preliminary evidence that a digital music-based mindfulness intervention can decrease race-based anxiety in Black Americans. Future research is needed to replicate these results, test whether the intervention can elicit lasting changes in anxiety, assess mechanisms of change, and explore the efficacy of the intervention in real-world contexts. %M 37585252 %R 10.2196/49284 %U https://formative.jmir.org/2023/1/e49284 %U https://doi.org/10.2196/49284 %U http://www.ncbi.nlm.nih.gov/pubmed/37585252 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43526 %T Effects of Community-Based Caring Contact in Reducing Thwarted Belongingness Among Postdischarge Young Adults With Self-Harm: Randomized Controlled Trial %A Law,Yik Wa %A Lok,Rita Hui Ting %A Chiang,Byron %A Lai,Carmen Chui Shan %A Tsui,Sik Hon Matthew %A Chung,Pui Yin Joseph %A Leung,Siu Chung %+ Department of Social Work and Social Administration, University of Hong Kong, RM534, The Jockey Club Tower,, The Centennial Campus, HKU, Pokfulam, Hong Kong, Hong Kong, 852 93029863, flawhk@hku.hk %K self-harm %K suicidal ideation %K volunteers %K mobile app %K thwarted belongingness %K suicide %K youth %K community %K support %K treatment %K effectiveness %K risk %K patient %K intervention %K model %K care %K hospital %D 2023 %7 16.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: For patients with self-harm behaviors, the urge to hurt themselves persists after hospital discharge, leading to costly readmissions and even death. Hence, postdischarge intervention programs that reduce self-harm behavior among patients should be part of a cogent community mental health care policy. Objective: We aimed to determine whether a combination of a self-help mobile app and volunteer support could complement treatment as usual (TAU) to reduce the risk of suicide among these patients. Methods: We conducted a pragmatic randomized controlled trial on discharged patients aged between 18 and 45 years with self-harm episodes/suicide attempts, all of whom were recruited from 4 hospital emergency departments in Hong Kong. Participants were randomly assigned to one of three groups: (1) mobile app + TAU (“apps”), (2) mobile app + volunteer support + TAU (“volunteers”), or (3) TAU only as the control group (“TAU”). They were asked to submit a mobile app–based questionnaire during 4 measurement time points at monthly intervals. Results: A total of 40 participants were recruited. Blending volunteer care with a preprogrammed mobile app was found to be effective in improving service compliance. Drawing upon the interpersonal-psychological theory of suicide, our findings suggested that a reduction in perceived burdensomeness and thwarted belongingness through community-based caring contact are linked to improvement in hopelessness, albeit a transient one, and suicide risk. Conclusions: A combination of volunteer care with a self-help mobile app as a strategy for strengthening the continuity of care can be cautiously implemented for discharged patients at risk of self-harm during the transition from the hospital to a community setting. Trial Registration: ClinicalTrials.gov NCT03081078; https://clinicaltrials.gov/study/NCT03081078 %M 37585260 %R 10.2196/43526 %U https://formative.jmir.org/2023/1/e43526 %U https://doi.org/10.2196/43526 %U http://www.ncbi.nlm.nih.gov/pubmed/37585260 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e41774 %T Web-Based 24-Hour Dietary Recall Tool for Russian Adults and School-Aged Children: Validation Study %A Pigat,Sandrine %A Soshina,Mariya %A Berezhnaya,Yulia %A Kryzhanovskaya,Ekaterina %+ PepsiCo, Inc, Leningradskii Prospect, 72/4, Moscow, 125315, Russian Federation, 7 495 937 05 50, Mariya.Soshina@pepsico.com %K dietary assessment %K 24-hour dietary recall %K extent of agreement %K energy and nutrient intake %K Russian diet %K interviewer-administered %K web-based self-administered %K diet %K food intake %K dietary recall %K energy intake %K nutrient intake %D 2023 %7 16.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Data on dietary intakes in Russian adults and children are assessed very infrequently primarily due to the time, cost, and burden to the participants for assessing dietary patterns. To overcome some of those challenges, the use of web-based 24-hour recall methods can be successfully used. Objective: The study objective is to assess the extent of agreement between a self-administered and an interviewer-administered 24-hour dietary recall in Russian adults and school-aged children using an adaptation of a web-based 24-hour recall tool. Methods: This web-based dietary assessment tool is based on a previously validated tool, which has been adapted to the Russian diet and language. A randomized 50% (n=97) of 194 participants initially completed a self-administered web-based dietary recall, followed by an interviewer-administered 24-hour dietary recall later that same day, and vice versa for the other 50% (n=97) of participants. Following at least 1 week wash-out period, during visit 2, participant groups completed the 2 dietary recalls in the opposite order. Statistical analysis was carried out on the intake results from both methods for the 2 recalls. Finally, an evaluation questionnaire on ease-of-use of the tool was also completed. Results: In total, intakes of 28 nutrients and energy were analyzed in this study. The Bland-Altman analysis showed that between 98.4% and 90.5% of data points were within the limits of agreement among all age groups and nutrients analyzed. A “moderate to excellent” reliability between the 2 methods was observed in younger children. In older children, a “moderate to good” reliability was observed, with the exception of sodium. In adults, “moderate to excellent” reliability between both methods was observed with the exception of vitamins B1, B2, and B6, and pantothenic acid. The level of agreement between the categorization of estimates into thirds of the intake distribution for the average of the 2 days was satisfactory, since the percentages of participants categorized into the same tertile of intake were ˃50%, and the percentages of participants categorized into the opposite tertile of intake were <10%. The majority of respondents were very positive in their evaluation of the web-based dietary assessment tool. Conclusions: Overall, the web-based dietary assessment tool performs well when compared with a face-to-face, interviewer-administered 24-hour dietary recall and provides comparable estimates of energy and nutrient intakes in Russian adults and children. Trial Registration: ClinicalTrials.gov NCT04372160; https://clinicaltrials.gov/ct2/show/NCT04372160 %M 37585243 %R 10.2196/41774 %U https://formative.jmir.org/2023/1/e41774 %U https://doi.org/10.2196/41774 %U http://www.ncbi.nlm.nih.gov/pubmed/37585243 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e46061 %T Relationship Factors in Internet-Delivered Psychological Interventions for Veterans Experiencing Postpartum Depression: Qualitative Analysis %A Solness,Cara L %A Holdefer,Paul J %A Hsu,Ti %A Thomas,Emily B K %A O'Hara,Michael W %+ Department of Psychiatry, School of Medicine, University of Colorado, 1890 N Revere Court, Anschutz Medical Campus, Aurora, CO, 80045, United States, 1 319 331 3566, cara.solness@cuanschutz.edu %K internet-delivered treatment %K postpartum depression %K therapeutic alliance %K qualitative methodology %K veteran %D 2023 %7 15.8.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Internet-delivered psychological interventions (IPIs) have been shown to be effective for a variety of psychological concerns, including postpartum depression. Human-supported programs produce better adherence and larger effect sizes than unsupported programs; however, what it is about support that affects outcomes is not well understood. Therapeutic alliance is one possibility that has been found to contribute to outcomes; however, the specific mechanism is not well understood. Participant perspectives and qualitative methodology are nearly absent from the IPI alliance research and may help provide new directions. Objective: In this study, we aimed to provide participant perspectives on engagement with an IPI for postpartum depression to help inform alliance research, development of new IPIs, and inform resource allocation. Methods: A qualitative methodology was used to explore participant perspectives of veteran women’s engagement with the MomMoodBooster program, a human-supported internet-delivered intervention for postpartum depression. Participants were asked 4 open-ended questions with the 3-month postintervention survey, “In what ways did you find the MomMoodBooster most helpful?” “How do you think the MomMoodBooster could have been improved?” “In what ways did you find the personal coach calls to be helpful?” and “How do you think the personal coach calls could have been improved?” Results: Data were collected from 184 participants who responded to at least 1 of the open-ended questions. These were analyzed using thematic analysis and a process of reaching a consensus among coders. The results suggest that not only the engagement with the support person is perceived as a significant contributor to participant experiences while using the MomMoodBooster content but also the relationship factors are particularly meaningful. The results provide insights into the specific qualities of the support person that were perceived as most impactful, such as warmth, empathy and genuineness, and feeling normalized and supported. In addition, the results provide insight into the specific change processes that can be targeted through support interactions, such as encouraging self-reflection and self-care and challenging negative thinking. Conclusions: These data emphasize the importance of relationship factors between support persons and an IPI program for postpartum depression. The findings suggest that focusing on specific aspects of the alliance and the therapeutic relationship could yield fruitful directions for the training of support personnel and for future alliance-based research of internet-delivered treatments. %M 37581917 %R 10.2196/46061 %U https://mental.jmir.org/2023/1/e46061 %U https://doi.org/10.2196/46061 %U http://www.ncbi.nlm.nih.gov/pubmed/37581917 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 10 %N %P e49673 %T Managing Musculoskeletal Pain in Older Adults Through a Digital Care Solution: Secondary Analysis of a Prospective Clinical Study %A Areias,Anabela C %A Janela,Dora %A Molinos,Maria %A Moulder,Robert G %A Bento,Virgílio %A Yanamadala,Vijay %A Cohen,Steven P %A Correia,Fernando Dias %A Costa,Fabíola %+ Sword Health, Inc, 13937 Sprague Lane, Suite 100, Draper, UT, 84020, United States, 1 385 308 8034, f.costa@swordhealth.com %K aged %K digital therapy %K eHealth %K musculoskeletal conditions %K older adults %K pain %K physical therapy %K telehealth %K telerehabilitation %D 2023 %7 15.8.2023 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: Aging is closely associated with an increased prevalence of musculoskeletal conditions. Digital musculoskeletal care interventions emerged to deliver timely and proper rehabilitation; however, older adults frequently face specific barriers and concerns with digital care programs (DCPs). Objective: This study aims to investigate whether known barriers and concerns of older adults impacted their participation in or engagement with a DCP or the observed clinical outcomes in comparison with younger individuals. Methods: We conducted a secondary analysis of a single-arm investigation assessing the recovery of patients with musculoskeletal conditions following a DCP for up to 12 weeks. Patients were categorized according to age: ≤44 years old (young adults), 45-64 years old (middle-aged adults), and ≥65 years old (older adults). DCP access and engagement were evaluated by assessing starting proportions, completion rates, ability to perform exercises autonomously, assistance requests, communication with their physical therapist, and program satisfaction. Clinical outcomes included change between baseline and program end for pain (including response rate to a minimal clinically important difference of 30%), analgesic usage, mental health, work productivity, and non–work-related activity impairment. Results: Of 16,229 patients, 12,082 started the program: 38.3% (n=4629) were young adults, 55.7% (n=6726) were middle-aged adults, and 6% (n=727) were older adults. Older patients were more likely to start the intervention and to complete the program compared to young adults (odds ratio [OR] 1.72, 95% CI 1.45-2.06; P<.001 and OR 2.40, 95% CI 1.97-2.92; P<.001, respectively) and middle-aged adults (OR 1.22, 95% CI 1.03-1.45; P=.03 and OR 1.38, 95% CI 1.14-1.68; P=.001, respectively). Whereas older patients requested more technical assistance and exhibited a slower learning curve in exercise performance, their engagement was higher, as reflected by higher adherence to both exercise and education pieces. Older patients interacted more with the physical therapist (mean 12.6, SD 18.4 vs mean 10.7, SD 14.7 of young adults) and showed higher satisfaction scores (mean 8.7, SD 1.9). Significant improvements were observed in all clinical outcomes and were similar between groups, including pain response rates (young adults: 949/1516, 62.6%; middle-aged adults: 1848/2834, 65.2%; and older adults: 241/387, 62.3%; P=.17). Conclusions: Older adults showed high adherence, engagement, and satisfaction with the DCP, which were greater than in their younger counterparts, together with significant clinical improvements in all studied outcomes. This suggests DCPs can successfully address and overcome some of the barriers surrounding the participation and adequacy of digital models in the older adult population. %M 37465960 %R 10.2196/49673 %U https://rehab.jmir.org/2023/1/e49673 %U https://doi.org/10.2196/49673 %U http://www.ncbi.nlm.nih.gov/pubmed/37465960 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e40470 %T Delivery of the HIV Service and Telemedicine Through Effective Patient-Reported Outcomes (+STEP) Intervention to Increase Screening and Treatment of Mental Health and Substance Use Disorders for People Living With HIV in Alabama: Protocol for an Effectiveness-Implementation Study %A Gagnon,Kelly W %A Baral,Stefan %A Long,Dustin %A Guzman,Alfredo L %A Johnson,Bernadette %A Burkholder,Greer %A Willig,James %A Mugavero,Michael %A Baldwin,Margaret %A Fogger,Susanne %A Creger,Thomas %A Cropsey,Karen %A Eaton,Ellen %+ Division of Infectious Disease, Heersink School of Medicine, University of Alabama at Birmingham, 1808 7th Ave S, Birmingham, AL, 35233, United States, 1 6103295650, kgagnon@uabmc.edu %K clinics %K diagnosis %K engagement %K HIV %K implementation science %K intervention %K interview %K mental health %K patient reported outcomes %K protocol %K screening %K substance use %K telemedicine %K treatment %K USA %K viral %D 2023 %7 15.8.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: The syndemic of mental health (MH) and substance use disorders (SUDs) is common among persons living with HIV and jeopardizes HIV treatment adherence, engagement in care, and viral load suppression. Electronic patient-reported outcomes (ePROs), completed through tablet or computer, and telemedicine are evidence- and technology-based interventions that have been used to successfully increase screening and treatment, respectively, a model that holds promise for persons living with HIV. To date, there is limited guidance on implementing ePROs and telemedicine into HIV clinical practice even though it is well known that these evidence-based tools improve diagnosis and access to care. Objective: To address this, we aim to conduct a multicomponent intervention for persons living with HIV, including the delivery of HIV services and telemedicine through effective ePROs (+STEP), to increase screening and treatment of MH and SUD in Ryan White HIV/AIDS Program (RWHAP)–funded clinics in Alabama. Methods: Through this intervention, we will conduct a readiness, acceptability, and accessibility assessment and implement +STEP to improve the diagnosis and treatment of MH and SUD at RWHAP clinics in Alabama. To describe implementation strategies that address barriers to the uptake of +STEP in RWHAP clinics, we will conduct qualitative interviews in years 1 (early implementation), 2 (scale up), and 4 (maintenance) with patients and key staff to evaluate barriers, facilitators, and implementation strategies. Our Results will enable us to modify strategies to enhance +STEP penetration over time and inform the implementation blueprint, which we will develop for both RWHAP clinics in Alabama and future sites. We will assess the impact of implementing +STEP on diagnoses, referrals, and health care use related to MH, SUD, and HIV by comparing clinical outcomes from patients receiving these interventions (ePROs and telemedicine) with historical controls. Results: The first study site began implementation in April 2022. A total of 2 additional sites have initiated ePROs. Final results are expected in 2026. The results of this study will provide a foundation for future research expanding access to ePROs for improved diagnosis linked to telemedicine access to accelerate patients along the continuum of care from MH and SUD diagnosis to treatment. Conclusions: Achieving the end of the HIV epidemic in the United States necessitates programs that accelerate movement across the MH and SUD care continuum from diagnosis to treatment for persons living with HIV. Scaling these services represents a path toward improved treatment outcomes with both individual health and population-level prevention benefits of sustained HIV viral suppression in the era of undetectable=untransmittable (U=U). This study will address this evidence gap through the evaluation of the implementation of +STEP to establish the necessary systems and processes to screen, identify, and better treat substance use and MH for people living with HIV. International Registered Report Identifier (IRRID): DERR1-10.2196/40470 %M 37581919 %R 10.2196/40470 %U https://www.researchprotocols.org/2023/1/e40470 %U https://doi.org/10.2196/40470 %U http://www.ncbi.nlm.nih.gov/pubmed/37581919 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e40157 %T Effectiveness of a Web-Based Intervention for Preventing Substance Use in Young Adults in Taiwan: Quasi-Experimental Study %A Chang,Yen-Jung %A Chen,Jhong-Lin %+ Department of Health Promotion and Health Education, National Taiwan Normal University, 162, Section 1, Heping E. Rd., Taipei, 106, Taiwan, 886 2 7749 1733, yjchang@ntnu.edu.tw %K controlled substances %K health education %K illicit drugs %K prevention %K substance use %K web-based intervention %K young adults %D 2023 %7 14.8.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Substance use has been one of the most alarming public health problems worldwide, particularly among younger generations. Objective: This study evaluated the effectiveness of a web-based substance use prevention intervention targeted at adults aged 20-29 years. Methods: The intervention materials comprised 5 sets of infographics and 1 animation, all of which focused on mixed themes: (1) the concept of substance use and its harmful effects on health; (2) misinformation regarding new psychoactive substances; (3) regulation of illicit drugs, particularly marijuana; (4) the brain disease model of addiction; (5) critical thinking skills that improve health literacy; and (6) decision-making and communication skills that help people refuse illegal drugs. The study assigned eligible participants into experimental and control groups on the basis of the parity of their participant numbers. These participants completed web-based baseline and follow-up questionnaires that assessed their knowledge, behavioral intention, self-efficacy, and life skills related to substance use prevention. Knowledge was assessed using 8 questions concerning understanding of substance use harms and the regulation of illicit drugs. Behavioral intention and self-efficacy were assessed using 5-point Likert-type scales. Participants’ ability to apply life skills to avoid substance use was assessed using 3 testing scenarios regarding substance use. The study used generalized estimating equations to examine the intervention’s effectiveness. Results: A total of 1065 participants (539 control and 526 experimental) completed the intervention and questionnaires in 2019. The average ages of the experimental and control groups were 25.68 (SD 2.71) and 25.66 (SD 2.69) years, respectively. The study observed no significant differences in the demographic variables between the 2 groups. The results of the generalized estimating equation analyses indicated that the intervention significantly improved participants’ knowledge (P<.001), behavioral intention (P<.001), and self-efficacy (P<.001) but not their life skills (P=.61) related to substance use prevention. Participants in the experimental group responded to a satisfaction survey with positive feedback on the intervention. Conclusions: The web-based intervention was effective in improving participants’ knowledge, behavioral intention, and self-efficacy concerning substance use prevention. The findings support continued efforts to use web-based interventions to prevent substance use among young adults. %M 37578821 %R 10.2196/40157 %U https://www.jmir.org/2023/1/e40157 %U https://doi.org/10.2196/40157 %U http://www.ncbi.nlm.nih.gov/pubmed/37578821 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47968 %T An App to Support Fathers’ Mental Health and Well-Being: User-Centered Development Study %A Liverpool,Shaun %A Eisenstadt,Mia %A Mulligan Smith,Aoife %A Kozhevnikova,Sofia %+ Evidence Based Practice Unit, Anna Freud National Centre for Children and Families, University College London, 4-8 Rodney Street London, London, N1 9JH, United Kingdom, 44 7960674724, mia.eisenstadt@annafreud.org %K fathers %K parenting %K apps %K mental health %K well-being %D 2023 %7 14.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Numerous studies describe the popularity and usefulness of parenting programs. In particular, parenting programs are generally viewed as effective for supporting parents’ mental well-being during key transition periods. However, the evidence base for fathers is limited owing to their lack of involvement in parenting programs and scarcity of tailored support. Objective: This paper aimed to describe the co-design process for a universal digital intervention for fathers (fatherli) and the outline of a logic model with its expected outcomes. Methods: Following established guidelines for co-designing and developing complex interventions, we conducted a nonsystematic review of the available literature to gather key information, developed market surveys to assess fathers’ needs and interests, consulted with key stakeholders to obtain expert opinions, and engaged in a rapid iterative prototyping process with app developers. Each step was summarized, and the information was collated and integrated to inform a logic model and the features of the resulting intervention. Results: The steps in the co-design process confirmed a need for and interest in a digital intervention for fathers. In response to this finding, fatherli was developed, consisting of 5 key features: a discussion forum for anyone to post information about various topics (the forum), a socializing platform for fathers to create and engage with others in small groups about topics or points of shared interest (dad hub), a tool for fathers to find other fathers with shared interests or within the same geographic location (dad finder), a resource for fathers to access up-to-date information about topics that interest them (dad wiki), and a portal to book sessions with coaches who specialize in different topics (dad coaching space). The evidence-based logic model proposes that if fatherli is successfully implemented, important outcomes such as increased parental efficacy and mental health help-seeking behaviors may be observed. Conclusions: We documented the co-design and development process of fatherli, which confirmed that it is possible to use input from end users and experts, integrated with theory and research evidence, to create suitable digital well-being interventions for fathers. In general, the key findings suggest that an app that facilitates connection, communication, and psychoeducation may appeal to fathers. Further studies will now focus on acceptability, feasibility, and effectiveness. Feedback gathered during pilot-testing will inform any further developments in the app to increase its applicability to fathers and its usability. %M 37578834 %R 10.2196/47968 %U https://formative.jmir.org/2023/1/e47968 %U https://doi.org/10.2196/47968 %U http://www.ncbi.nlm.nih.gov/pubmed/37578834 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45749 %T Investigating Relationships Among Self-Efficacy, Mood, and Anxiety Using Digital Technologies: Randomized Controlled Trial %A Rohde,Judith %A Marciniak,Marta Anna %A Henninger,Mirka %A Homan,Stephanie %A Paersch,Christina %A Egger,Stephan T %A Seifritz,Erich %A Brown,Adam D %A Kleim,Birgit %+ Department of Psychiatry, Psychotherapy and Psychosomatic, Psychiatric University Hospital Zurich, Lenggstrasse 31, Zurich, 8008, Switzerland, 41 058 384 2111, judith.rohde@uzh.ch %K self-efficacy %K digital intervention %K digital assessment %K EMA %K EMI %K mood %K anxiety %K emotional flexibility %D 2023 %7 14.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital tools assessing momentary parameters and offering interventions in people’s daily lives play an increasingly important role in mental health research and treatment. Ecological momentary assessment (EMA) makes it possible to assess transient mental health states and their parameters. Ecological momentary interventions (EMIs) offer mental health interventions that fit well into individuals’ daily lives and routines. Self-efficacy is a transdiagnostic construct that is commonly associated with positive mental health outcomes. Objective: The aim of our study assessing mood, specific self-efficacy, and other parameters using EMA was 2-fold. First, we wanted to determine the effects of daily assessed moods and dissatisfaction with social contacts as well as the effects of baseline variables, such as depression, on specific self-efficacy in the training group (TG). Second, we aimed to explore which variables influenced both groups’ positive and negative moods during the 7-day study period. Methods: In this randomized controlled trial, we applied digital self-efficacy training (EMI) to 93 university students with elevated self-reported stress levels and daily collected different parameters, such as mood, dissatisfaction with social contacts, and specific self-efficacy, using EMA. Participants were randomized to either the TG, where they completed the self-efficacy training combined with EMA, or the control group, where they completed EMA only. Results: In total, 93 university students participated in the trial. Positive momentary mood was associated with higher specific self-efficacy in the evening of the same day (b=0.15, SE 0.05, P=.005). Higher self-efficacy at baseline was associated with reduced negative mood during study participation (b=–0.61, SE 0.30, P=.04), while we could not determine an effect on positive mood. Baseline depression severity was significantly associated with lower specific self-efficacy over the week of the training (b=–0.92, SE 0.35, P=.004). Associations between higher baseline anxiety with higher mean negative mood (state anxiety: b=0.78, SE 0.38, P=.04; trait anxiety: b=0.73, SE 0.33, P=.03) and lower mean positive mood (b=–0.64, SE 0.28, P=.02) during study participation were found. Emotional flexibility was significantly enhanced in the TG. Additionally, dissatisfaction with social contacts was associated with both a decreased positive mood (b=–0.56, SE 0.15, P<.001) and an increased negative mood (b=0.45, SE 0.12, P<.001). Conclusions: This study showed several significant associations between mood and self-efficacy as well as those between mood and anxiety in students with elevated stress levels, for example, suggesting that improving mood in people with low mood could enhance the effects of digital self-efficacy training. In addition, engaging in 1-week self-efficacy training was associated with increased emotional flexibility. Future work is needed to replicate and investigate the training’s effects in other groups and settings. Trial Registration: ClinicalTrials.gov NCT05617248; https://clinicaltrials.gov/study/NCT05617248 %M 37578827 %R 10.2196/45749 %U https://formative.jmir.org/2023/1/e45749 %U https://doi.org/10.2196/45749 %U http://www.ncbi.nlm.nih.gov/pubmed/37578827 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43727 %T Assessing Patient Adherence to and Engagement With Digital Interventions for Depression in Clinical Trials: Systematic Literature Review %A Forbes,Ainslie %A Keleher,Madeline Rose %A Venditto,Michael %A DiBiasi,Faith %+ Otsuka Pharmaceutical Development & Commercialization, Inc, 508 Carnegie Center Dr, Princeton, NJ, 08540, United States, 1 301 956 2702, ainslie.forbes@otsuka-us.com %K digital therapeutics %K digital interventions %K digital health %K mobile health %K mobile phone %K depression %K major depressive disorder %K engagement %K adherence %K systematic literature review %D 2023 %7 11.8.2023 %9 Review %J J Med Internet Res %G English %X Background: New approaches to the treatment of depression are necessary for patients who do not respond to current treatments or lack access to them because of barriers such as cost, stigma, and provider shortage. Digital interventions for depression are promising; however, low patient engagement could limit their effectiveness. Objective: This systematic literature review (SLR) assessed how participant adherence to and engagement with digital interventions for depression have been measured in the published literature, what levels of adherence and engagement have been reported, and whether higher adherence and increased engagement are linked to increased efficacy. Methods: We focused on a participant population of adults (aged ≥18 years) with depression or major depressive disorder as the primary diagnosis and included clinical trials, feasibility studies, and pilot studies of digital interventions for treating depression, such as digital therapeutics. We screened 756 unique records from Ovid MEDLINE, Embase, and Cochrane published between January 1, 2000, and April 15, 2022; extracted data from and appraised the 94 studies meeting the inclusion criteria; and performed a primarily descriptive analysis. Otsuka Pharmaceutical Development & Commercialization, Inc (Princeton, New Jersey, United States) funded this study. Results: This SLR encompassed results from 20,111 participants in studies using 47 unique web-based interventions (an additional 10 web-based interventions were not described by name), 15 mobile app interventions, 5 app-based interventions that are also accessible via the web, and 1 CD-ROM. Adherence was most often measured as the percentage of participants who completed all available modules. Less than half (44.2%) of the participants completed all the modules; however, the average dose received was 60.7% of the available modules. Although engagement with digital interventions was measured differently in different studies, it was most commonly measured as the number of modules completed, the mean of which was 6.4 (means ranged from 1.0 to 19.7) modules. The mean amount of time participants engaged with the interventions was 3.9 (means ranged from 0.7 to 8.4) hours. Most studies of web-based (34/45, 76%) and app-based (8/9, 89%) interventions found that the intervention group had substantially greater improvement for at least 1 outcome than the control group (eg, care as usual, waitlist, or active control). Of the 14 studies that investigated the relationship between engagement and efficacy, 9 (64%) found that increased engagement with digital interventions was significantly associated with improved participant outcomes. The limitations of this SLR include publication bias, which may overstate engagement and efficacy, and low participant diversity, which reduces the generalizability. Conclusions: Patient adherence to and engagement with digital interventions for depression have been reported in the literature using various metrics. Arriving at more standardized ways of reporting adherence and engagement would enable more effective comparisons across different digital interventions, studies, and populations. %M 37566447 %R 10.2196/43727 %U https://www.jmir.org/2023/1/e43727 %U https://doi.org/10.2196/43727 %U http://www.ncbi.nlm.nih.gov/pubmed/37566447 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46034 %T Exploring the Impact of Dawn Phenomenon on Glucose-Guided Eating Thresholds in Individuals With Type 2 Diabetes Using Continuous Glucose Monitoring: Observational Study %A Jospe,Michelle R %A Marano,Kari M %A Bedoya,Arianna R %A Behrens,Nick L %A Cigan,Lacey %A Villegas,Vanessa %A Magee,Michelle F %A Marrero,David G %A Richardson,Kelli M %A Liao,Yue %A Schembre,Susan M %+ Lombardi Comprehensive Cancer Center, Georgetown University, 800 Reservoir Rd NW, Washington, DC, 20057, United States, 1 202 444 2223, ss4731@georgetown.edu %K glucose-guided eating %K dawn phenomenon %K eating timing %K eating behavior %K type 2 diabetes %K appetite regulation %K blood glucose self-monitoring %K food intake regulation %K glycemic control %K continuous glucose monitoring %K glucose %K appetite %K diabetes %K diabetic %K type 2 %K monitoring %K blood sugar %K mobile phone %D 2023 %7 11.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Glucose-guided eating (GGE) improves metabolic markers of chronic disease risk, including insulin resistance, in adults without diabetes. GGE is a timed eating paradigm that relies on experiencing feelings of hunger and having a preprandial glucose level below a personalized threshold computed from 2 consecutive morning fasting glucose levels. The dawn phenomenon (DP), which results in elevated morning preprandial glucose levels, could cause typically derived GGE thresholds to be unacceptable or ineffective among people with type 2 diabetes (T2DM). Objective: The aim of this study is to quantify the incidence and day-to-day variability in the magnitude of DP and examine its effect on morning preprandial glucose levels as a preliminary test of the feasibility of GGE in adults with T2DM. Methods: Study participants wore a single-blinded Dexcom G6 Pro continuous glucose monitoring (CGM) system for up to 10 days. First and last eating times and any overnight eating were reported using daily surveys over the study duration. DP was expressed as a dichotomous variable at the day level (DP day vs non-DP day) and as a continuous variable reflecting the percent of days DP was experienced on a valid day. A valid day was defined as having no reported overnight eating (between midnight and 6 AM). ∂ Glucose was computed as the difference in nocturnal glucose nadir (between midnight and 6 AM) to morning preprandial glucose levels. ∂ Glucose ≥20 mg/dL constituted a DP day. Using multilevel modeling, we examined the between- and within-person effects of DP on morning preprandial glucose and the effect of evening eating times on DP. Results: In total, 21 adults (59% female; 13/21, 62%) with non–insulin-treated T2DM wore a CGM for an average of 10.5 (SD 1.1) days. Twenty out of 21 participants (95%) experienced DP for at least 1 day, with an average of 51% of days (SD 27.2; range 0%-100%). The mean ∂ glucose was 23.7 (SD 13.2) mg/dL. People who experience DP more frequently had a morning preprandial glucose level that was 54.1 (95% CI 17.0-83.9; P<.001) mg/dL higher than those who experienced DP less frequently. For within-person effect, morning preprandial glucose levels were 12.1 (95% CI 6.3-17.8; P=.008) mg/dL higher on a DP day than on a non-DP day. The association between ∂ glucose and preprandial glucose levels was 0.50 (95% CI 0.37-0.60; P<.001). There was no effect of the last eating time on DP. Conclusions: DP was experienced by most study participants regardless of last eating times. The magnitude of the within-person effect of DP on morning preprandial glucose levels was meaningful in the context of GGE. Alternative approaches for determining acceptable and effective GGE thresholds for people with T2DM should be explored and evaluated. %M 37566445 %R 10.2196/46034 %U https://formative.jmir.org/2023/1/e46034 %U https://doi.org/10.2196/46034 %U http://www.ncbi.nlm.nih.gov/pubmed/37566445 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44922 %T The Impact of Social Media Use Interventions on Mental Well-Being: Systematic Review %A Plackett,Ruth %A Blyth,Alexandra %A Schartau,Patricia %+ Research Department of Primary Care & Population Health, University College London, Royal Free Hospital, Rowland Hill Street, London, NW3 2PF, United Kingdom, 44 20 3108 3096, ruth.plackett.15@ucl.ac.uk %K review %K social media %K mental well-being %K mental health %K addiction %K intervention %K mobile phone %D 2023 %7 11.8.2023 %9 Review %J J Med Internet Res %G English %X Background: There is some evidence that more social media use is related to poorer mental well-being and that social media use can become problematic when it starts to interfere with a person’s daily life and mental well-being. To address this issue and improve users’ mental well-being, social media use interventions (eg, abstinence from social media) have been developed and evaluated. However, there is limited understanding of the effectiveness of these interventions in improving mental well-being. Objective: This systematic review aimed to synthesize the literature on the effectiveness of social media use interventions in improving mental well-being in adults. Methods: A systematic search (January 1, 2004, to July 31, 2022) was completed across 3 databases in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Experimental studies evaluating the impact of social media use interventions on mental well-being in adults were included. Outcomes related to mental well-being, such as depression, anxiety, stress, and loneliness, were included. A narrative synthesis without meta-analysis was completed to summarize the study characteristics and effectiveness by outcome and intervention type. The Effective Public Health Practice Project Quality Assessment Tool was used to measure the quality of the studies. Results: Of the 2785 studies identified through the systematic search, 23 (0.83%) were included in the analysis. Many of the included studies (9/23, 39%) found improvements in mental well-being, some (7/23, 30%) found mixed effects, and others (7/23, 30%) found no effect on mental well-being. Therapy-based interventions that used techniques such as cognitive behavioral therapy were more effective than limiting use of social media or full abstinence from social media, with 83% (5/6) of these studies showing improvements in mental well-being compared with 20% (1/5) and 25% (3/12), respectively. Depression was the most frequently investigated and improved outcome with 70% (7/10) of the studies showing a significant improvement in depression after the intervention, whereas other outcomes showed more varied results. Quality was poor, with 96% (22/23) of the studies receiving a weak global score, mostly for issues related to selection bias because most of the studies (16/23, 70%) used a convenience sampling of university students. Conclusions: This review provides some evidence that social media use interventions are effective in improving mental well-being, especially for depression and when using therapy-based interventions. Further experimental and longitudinal research is needed with representative samples to investigate who may benefit most from social media use interventions. This will help to develop guidance and recommendations for policy makers and clinicians on how best to manage problematic social media use. %M 37565693 %R 10.2196/44922 %U https://www.jmir.org/2023/1/e44922 %U https://doi.org/10.2196/44922 %U http://www.ncbi.nlm.nih.gov/pubmed/37565693 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45054 %T A Web-Based Sexual Health Intervention to Prevent Sexually Transmitted Infections in Hong Kong: Model-Based Cost-Effectiveness Analysis %A Zhang,Wen %A Wong,Carlos K H %A Xin,Yiqiao %A Fong,Daniel Y T %A Wong,Janet Y H %+ School of Nursing and Health Studies, Hong Kong Metropolitan University, 11/F, Jockey Club Institute of Healthcare, 1 Sheung Shing Street, Ho Man Tin, Kowloon, Hong Kong, China (Hong Kong), 852 3970 2988, jyhwong@hkmu.edu.hk %K economic evaluation %K web-based intervention %K young adult %K cost-effectiveness %K sexual health %K sexually transmitted infection %K STI %K digital intervention %D 2023 %7 10.8.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Sexually transmitted infections (STIs) remain a significant public health concern, particularly among young adults, and Chlamydia trachomatis (CT) infections are the most common STIs in young women. One of the most effective ways to prevent STIs is the consistent use of condoms during sexual intercourse. There has been no economic evaluation of the interactive web-based sexual health program, Smart Girlfriend, within the Chinese population. Objective: This study aimed to evaluate the long-term cost-effectiveness of Smart Girlfriend in preventing STIs in the Chinese population. The evaluation compared the program with a control intervention that used a 1-page information sheet on condom use. Methods: A decision-analytic model that included a decision tree followed by a Markov structure of CT infections was developed since CT is the most prevalent STI among young women. The model represents the long-term experience of individuals who received either the intervention or the control. One-way and probabilistic sensitivity analyses were conducted. The main outcomes were the number of CT infections and the incremental cost as per quality-adjusted life year (QALY). Results: A cohort of 10,000 sexually active nonpregnant young women initially entered the model in a noninfectious state (ie, “well”). In the base-case analysis, the implementation of the Smart Girlfriend program resulted in the prevention of 0.45% of CT infections, 0.3% of pelvic inflammatory disease, and 0.04% of chronic pelvic pain, leading to a gain of 70 discounted QALYs and cost savings over a 4-year time horizon, compared to the control group. With more than 4548 users, the intervention would be cost-effective, and with more than 8315 users, the intervention would be cost saving. A 99% probability of being cost-effective was detected with a willingness to pay US $17,409 per QALY. Conclusions: Smart Girlfriend is a cost-effective and possibly cost-saving program over a 4-year time horizon. This result was particularly sensitive to the number of website users; launching the website would be cost-effective if more than 4548 people used it. Further work is warranted to explore if the findings could be expanded to apply to women who have sex with women and in the context of other STIs. Trial Registration: ClinicalTrial.gov NCT03695679; https://clinicaltrials.gov/study/NCT03695679 %M 37561571 %R 10.2196/45054 %U https://www.jmir.org/2023/1/e45054 %U https://doi.org/10.2196/45054 %U http://www.ncbi.nlm.nih.gov/pubmed/37561571 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 8 %N %P e44297 %T Use of a Smartphone-Based Medication Adherence Platform to Improve Outcomes in Uncontrolled Type 2 Diabetes Among Veterans: Prospective Case-Crossover Study %A Rai,Amneet %A Riddle,Mark %A Mishra,Rajendra %A Nguyen,Nhien %A Valine,Kelly %A Fenney,Megan %+ Veterans Affairs Sierra Nevada Healthcare System, 975 Kirman Ave, Reno, NV, 89502, United States, 1 775 326 2796, amneetrai@gmail.com %K application %K biguanide %K blood glucose %K case-crossover %K diabetes management %K diabetes %K diabetic %K digital health intervention %K epidemiology %K glucose monitoring %K glucose %K HbgA1c %K hemoglobin A1c %K hemoglobin %K hyperlipidemia %K hypertension %K interquartile range %K IQR %K MAS %K Medication Adherence Scores %K medication adherence %K mobile health intervention %K mobile phone %K odds ratio %K paired t test %K quasi experimental %K SEAMS %K Self-Efficacy for Appropriate Medication Use Scale %K smartphone %K sulfonylurea %K T2DM %K Type 2 Diabetes Mellitus %K veteran %D 2023 %7 10.8.2023 %9 Original Paper %J JMIR Diabetes %G English %X Background: Medication nonadherence is a problem that impacts both the patient and the health system. Objective: The objective of this study was to evaluate the impact of a novel smartphone app with patient-response-directed clinical intervention on medication adherence and blood glucose control in noninsulin-dependent patients with type 2 diabetes mellitus (T2DM). Methods: We enrolled 50 participants with T2DM not on insulin with smartphones from a rural health care center in Northern Nevada for participation in this case-crossover study. Participants underwent a standard of care arm and an intervention arm. Each study arm was 3 months long, for a total of 6 months of follow-up. Participants had a hemoglobin A1c (HbA1c) lab draw at enrollment, 3 months, and 6 months. Participants had monthly “medication adherence scores” (MAS) and “Self-Efficacy for Appropriate Medication Use Scale” (SEAMS) questionnaires completed at baseline and monthly for the duration of the study. Our primary outcomes of interest were the changes in HbA1c between study arms. Secondary outcomes included the evaluation of the difference in the proportion of participants achieving a clinically meaningful reduction in HbA1c and the difference in the number of participants requiring diabetes therapy escalation between study arms. Exploratory outcomes included the analysis of the variation in medication possession ratio (MPR), MAS, and SEAMS during each study arm. Results: A total of 30 participants completed both study arms and were included in the analysis. Dropouts were higher in participants enrolled in the standard of care arm first (9/25, 36% vs 4/25, 16%). Participants had a median HbA1c of 9.1%, had been living with T2DM for 6 years, had a median age of 66 years, and had a median of 8.5 medications. HbA1c reduction was 0.69% in the intervention arm versus 0.35% in the standard of care arm (P=.30). A total of 70% (21/30) of participants achieved a clinically meaningful reduction in HbA1c of 0.5% in the app intervention arm versus 40% (12/30) in the standard of care arm (odds ratio 2.29, 95% CI 0.94-5.6; P=.09). Participants had higher odds of a therapy escalation while in the standard of care arm (18/30, 60% vs 5/30, 16.7%, odds ratio 4.3, 95% CI 1.2-15.2; P=.02). The median MPR prior to enrollment was 109%, 112% during the study’s intervention arm, and 102% during the standard of care arm. The median real-time MAS was 93.2%. The change in MAS (1 vs –0.1; P=.02) and SEAMS (1.9 vs –0.2; P<.001) from baseline to month 3 was higher in the intervention arm compared to standard of care. Conclusions: A novel smartphone app with patient-response-directed provider intervention holds promise in the ability to improve blood glucose control in complex non–insulin-dependent T2DM and is worthy of additional study. %M 37561555 %R 10.2196/44297 %U https://diabetes.jmir.org/2023/1/e44297 %U https://doi.org/10.2196/44297 %U http://www.ncbi.nlm.nih.gov/pubmed/37561555 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45240 %T Developing a Digital Health Intervention for Conversation Skills After Brain Injury (convers-ABI-lity) Using a Collaborative Approach: Mixed Methods Study %A Avramović,Petra %A Rietdijk,Rachael %A Kenny,Belinda %A Power,Emma %A Togher,Leanne %+ Discipline of Speech Pathology, Faculty of Medicine and Health, The University of Sydney, Susan Wakil Health Building D18, Level 6, Camperdown, 2006, Australia, 61 422974185, petra.avramovic@sydney.edu.au %K brain injury %K cognitive-communication %K communication partner training %K digital health %K co-design %D 2023 %7 9.8.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: People with acquired brain injury (ABI) experience communication breakdown in everyday interactions many years after injury, negatively impacting social and vocational relationships. Communication partner training (CPT) is a recommended intervention approach in communication rehabilitation after ABI. Access to long-term services is essential, both in rural and remote locations. Digital health has potential to overcome the challenges of travel and improve cost efficiencies, processes, and clinical outcomes. Objective: We aimed to collaboratively develop a novel, multimodal web-based CPT intervention (convers-ABI-lity) with key stakeholders and evaluate its feasibility for improving conversation skills after brain injury. Methods: This mixed methods study consisted of 3 key stages guided by the Integrate, Design, Assess, and Share (IDEAS) framework for developing effective digital health interventions. Stage 1 included the integration of current end-user needs and perspectives with key treatment and theoretical components of existing evidence-based interventions, TBI Express and TBIconneCT. Stage 2 included the iterative design of convers-ABI-lity with feedback from end-user interviews (n=22) analyzed using content analysis. Participants were individuals with ABI, family members, health professionals, and paid support workers. Stage 3 included the evaluation of the feasibility through a proof-of-concept study (n=3). A total of 3 dyads (a person with ABI and their communication partner [CP]) completed 7 weeks of convers-ABI-lity, guided by a clinician. The outcome measures included blinded ratings of conversation samples and self-report measures. We analyzed postintervention participant interviews using content analysis to inform further intervention refinement and development. Results: Collaborative and iterative design and development during stages 1 and 2 resulted in the development of convers-ABI-lity. Results in stage 3 indicated positive changes in the blinded ratings of conversation samples for the participants with traumatic brain injury and their CPs. Statistically reliable positive changes were also observed in the self-report measures of social communication skills and quality of life. Intervention participants endorsed aspects of convers-ABI-lity, such as its complementary nature, self-guided web-based modules, clinician sessions, engaging content, and novel features. They reported the intervention to be relevant to their personal experience with cognitive-communication disorders. Conclusions: This study presents the outcome of using the IDEAS framework to guide the development of a web-based multimodal CPT intervention with input from key stakeholders. The results indicate promising outcomes for improving the conversation skills of people with ABI and their CPs. Further evaluation of intervention effectiveness and efficacy using a larger sample size is required. %M 37556179 %R 10.2196/45240 %U https://www.jmir.org/2023/1/e45240 %U https://doi.org/10.2196/45240 %U http://www.ncbi.nlm.nih.gov/pubmed/37556179 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e43959 %T Usability and Preliminary Efficacy of an Artificial Intelligence–Driven Platform Supporting Dietary Management in Diabetes: Mixed Methods Study %A Bul,Kim %A Holliday,Nikki %A Bhuiyan,Mohammad Rashed Alam %A Clark,Cain C T %A Allen,John %A Wark,Petra A %+ Research Institute for Health and Wellbeing, Coventry University, Priory Street, Coventry, CV1 5FB, United Kingdom, 44 07392096816, ac2658@coventry.ac.uk %K nutrition and dietetics %K general diabetes %K qualitative research %K preventive medicine %K web technology %K self-management %K diabetes %K nutrition %K deep learning %K artificial %K mobile phone %D 2023 %7 9.8.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Nutrition plays an important role in diabetes self-management. Web-based diabetes care, driven by artificial intelligence (AI), enables more personalized care. Objective: This study aimed to examine the usability and preliminary efficacy of a web-based AI-driven nutrition platform to support people with diabetes and their carers in identifying healthy recipes, meal planning, and web-based shopping. Methods: Diabetes UK signposted people with diabetes and their carers to the platform’s study-specific portal through its website, social media, and newsletters. A total of 73 adult participants with prediabetes or diabetes or their carers completed the baseline web-based survey. Of these 73 participants, 23 (32%) completed a web-based survey after 8 weeks of platform use. Web-based semistructured interviews were conducted with platform users (7/23, 30%) who agreed to be followed up and diabetes experts (n=3) who had nutrition and platform knowledge. The intervention consists of a web-based platform that incorporates AI to personalize recipes, meal planning, and shopping list experiences and was made available for 8 weeks. Baseline characteristics, satisfaction, system usability, and diabetes-related and general health indicators were assessed before and after using the platform for 8 weeks. Results: Reductions in weight (mean difference 4.5 kg/m2, 95% CI 1.0-12.0; P=.009; Cliff δ=0.33) and waist size (mean difference 3.9 cm, 95% CI 2.0-6.5; P=.008; Cliff δ=0.48) were found. Most of the participants (151/217, 69.6%) did not regularly use the platform and had low or very low engagement scores. However, the platform was perceived as accessible with no need for additional assistance (11/21, 52%), user-friendly (8/21, 38%), and easy to use (8/21, 38%), regardless of some usability issues. Saving recipes was the most popular feature, with 663 saved recipes. Conclusions: This study indicated that the usability of the nutrition platform was well perceived by users and their carers. As participants managed their diabetes well, adding an education component would be specifically relevant for people less familiar with the role of diet in diabetes management. To assess the platform’s effectiveness in improving diabetes-related health indicators, controlled studies with a larger and more diverse participant sample are recommended. %M 37556198 %R 10.2196/43959 %U https://humanfactors.jmir.org/2023/1/e43959 %U https://doi.org/10.2196/43959 %U http://www.ncbi.nlm.nih.gov/pubmed/37556198 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46841 %T The Effectiveness of Improving Infectious Disease–Specific Health Literacy Among Residents: WeChat-Based Health Education Intervention Program %A Zhao,Yusui %A Xu,Shuiyang %A Zhang,Xuehai %A Wang,Lei %A Huang,Yu %A Wu,Shuxian %A Wu,Qingqing %+ Zhejiang Provincial Center for Disease Control and Prevention, Department of Health Education, 3399 Binsheng Road, Hanghzhou, 310051, China, 86 0571 87118439, qqwu@cdc.zj.cn %K effectiveness %K health education %K infectious disease-specific health literacy %K intervention %K WeChat %D 2023 %7 9.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Infectious disease–specific health literacy (IDSHL) has become an important determinant of infectious disease incidence. It can not only reduce the incidence of re-emerging infectious diseases, but also effectively prevent the emergence of new infectious diseases such as COVID-19. WeChat, as a new media, has been proven to greatly reduce the chance of infectious diseases spreading from person to person, especially in case of respiratory infections. However, there is currently no concrete health education invention program to improve IDSHL using a WeChat public account. Objective: The aims of this study were as follows: (1) to determine the IDSHL of the population in Zhejiang, China; (2) to develop a health education program for the improvement of IDSHL using a WeChat public account; and (3) to evaluate the effectiveness of the health education program that was implemented in the prevention of infectious disease outbreaks. Methods: We used a standardized questionnaire, which consisted of 28 closed-ended questions, to measure the level and score of IDSHL before and after intervention. A multiple-stage stratified random sampling technique was used to select study participants from Zhejiang province in China, who were further divided randomly into 2 groups: the intervention and control groups. From July 2014 to January 2015, a WeChat-based health education intervention program was carried out on the intervention group. Standard descriptive statistics and chi-square and t tests were conducted to analyze the data. Results: A total of 3001 residents participated in the baseline survey of this study. At baseline, participant IDSHL rates were 73.29% and 72.12% for the intervention and control groups, respectively (Χ21=0.5; P=.50). After 7 months of intervention, 9.90% (297/3001) of participants dropped out of the study. Of the lost participants, 119 were from the intervention group and 178 were from the control group. There were significant differences between follow-up and lost participants with respect to age (P=.04), marital status (P=.02) and occupations (P=.002). After intervention, the intervention group scores in the different domains were higher than those in the control group (infectious disease–related knowledge, prevention, management, or treatment, identification of pathogens and infection sources, and cognitive ability). There were significant improvements in the IDSHL of participants in both the intervention and control groups (Χ21=135.9; P<.001 vs Χ21=9.1; P=.003), and there was a greater change in the IDSHL among the intervention group participants than among the control group participants (1230/1359, 90.51% vs 1038/1359, 77.17%). Conclusions: The health education intervention program using a WeChat public account proved to be an effective, feasible, and well-accepted means to improve the IDSHL of the general population. In the future, this health education intervention program can be used as a reference for prevention and treatment of infectious diseases. %M 37556189 %R 10.2196/46841 %U https://formative.jmir.org/2023/1/e46841 %U https://doi.org/10.2196/46841 %U http://www.ncbi.nlm.nih.gov/pubmed/37556189 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44888 %T Changes in Learning From Social Feedback After Web-Based Interpretation Bias Modification: Secondary Analysis of a Digital Mental Health Intervention Among Individuals With High Social Anxiety Symptoms %A Beltzer,Miranda L %A Daniel,Katharine E %A Daros,Alexander R %A Teachman,Bethany A %+ Center for Behavioral Intervention Technologies, Northwestern University Feinberg School of Medicine, 750 N. Lake Shore Dr., 10th Floor, Chicago, IL, 60611, United States, 1 9144622962, miranda.beltzer@northwestern.edu %K social anxiety %K reinforcement learning %K cognitive bias modification %K interpretation bias %K reward learning %K probabilistic learning %K Q-learning %K digital intervention %D 2023 %7 9.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Biases in social reinforcement learning, or the process of learning to predict and optimize behavior based on rewards and punishments in the social environment, may underlie and maintain some negative cognitive biases that are characteristic of social anxiety. However, little is known about how cognitive and behavioral interventions may change social reinforcement learning in individuals who are anxious. Objective: This study assessed whether a scalable, web-based cognitive bias modification for interpretations (CBM-I) intervention changed social reinforcement learning biases in participants with high social anxiety symptoms. This study focused on 2 types of social reinforcement learning relevant to social anxiety: learning about other people and learning about one’s own social performance. Methods: Participants (N=106) completed 2 laboratory sessions, separated by 5 weeks of ecological momentary assessment tracking emotion regulation strategy use and affect. Approximately half (n=51, 48.1%) of the participants completed up to 6 brief daily sessions of CBM-I in week 3. Participants completed a task that assessed social reinforcement learning about other people in both laboratory sessions and a task that assessed social reinforcement learning about one’s own social performance in the second session. Behavioral data from these tasks were computationally modeled using Q-learning and analyzed using mixed effects models. Results: After the CBM-I intervention, participants updated their beliefs about others more slowly (P=.04; Cohen d=−0.29) but used what they learned to make more accurate decisions (P=.005; Cohen d=0.20), choosing rewarding faces more frequently. These effects were not observed among participants who did not complete the CBM-I intervention. Participants who completed the CBM-I intervention also showed less-biased updating about their social performance than participants who did not complete the CBM-I intervention, learning similarly from positive and negative feedback and from feedback on items related to poor versus good social performance. Regardless of the intervention condition, participants at session 2 versus session 1 updated their expectancies about others more from rewarding (P=.003; Cohen d=0.43) and less from punishing outcomes (P=.001; Cohen d=−0.47), and they became more accurate at learning to avoid punishing faces (P=.001; Cohen d=0.20). Conclusions: Taken together, our results provide initial evidence that there may be some beneficial effects of both the CBM-I intervention and self-tracking of emotion regulation on social reinforcement learning in individuals who are socially anxious, although replication will be important. %M 37556186 %R 10.2196/44888 %U https://formative.jmir.org/2023/1/e44888 %U https://doi.org/10.2196/44888 %U http://www.ncbi.nlm.nih.gov/pubmed/37556186 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45293 %T Stimulating the Uptake of Preconception Care by Women With a Vulnerable Health Status Through mHealth App–Based Nudging (Pregnant Faster): Cocreation Design and Protocol for a Cohort Study %A Smith,Sharissa M %A Bais,Babette %A Ismaili M'hamdi,Hafez %A Schermer,Maartje H N %A Steegers-Theunissen,Regine P M %+ Department of Obstetrics and Gynecology, Erasmus University Medical Center, Doctor Molewaterplein 40, Rotterdam, 3015GD, Netherlands, 31 0107040704, r.steegers@erasmusmc.nl %K preconception care %K periconception %K health inequality %K socioeconomic status %K lifestyle %K ethics %K mobile health %K mHealth %K mental stressor %K pregnancy %K mobile phone %D 2023 %7 9.8.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Women with a low socioeconomic status often have a vulnerable health status due to an accumulation of health-deteriorating factors such as poor lifestyle behaviors, including inadequate nutrition, mental stressors, and impaired health literacy and agency, which puts them at an unnecessary high risk of adverse pregnancy outcomes. Adequately preparing for pregnancy through preconception care (PCC) uptake and lifestyle improvement can improve these outcomes. We hypothesize that nudging is a successful way of encouraging engagement in PCC. A nudge is a behavioral intervention that changes choice behavior through influencing incentives. The mobile health (mHealth) app–based loyalty program Pregnant Faster aims to reward women in an ethically justified way and nudges to engage in pregnancy preparation by visiting a PCC consultation. Objective: Here, we first describe the process of the cocreation of the mHealth app Pregnant Faster that aims to increase engagement in pregnancy preparation by women with a vulnerable health status. Second, we describe the cohort study design to assess the feasibility of Pregnant Faster. Methods: The content of the app is based on the eHealth lifestyle coaching program Smarter Pregnancy, which has proven to be effective in ameliorating preconceptional lifestyle behaviors (folic acid, vegetables, fruits, smoking, and alcohol) and an interview study pertaining to the preferences of the target group with regard to an mHealth app stimulating PCC uptake. For moral guidance on the design, an ethical framework was developed based on the bioethical principles of Beauchamp and Childress. The app was further developed through iterative cocreation with the target group and health care providers. For 4 weeks, participants will engage with Pregnant Faster, during which opportunities will arise to earn coins such as reading informative blogs and registering for a PCC consultation. Coins can be spent on small fun rewards, such as folic acid, fruits, and mascara. Pregnant Faster’s feasibility will be tested in a study including 40 women aged 18 to 45 years, who are preconceptional or <8 weeks pregnant, with a low educational level, and living in a deprived neighborhood. The latter 2 factors will serve as a proxy of a low socioeconomic status. Recruitment will take place through flyers, social media, and health care practices. After finalization, participants will evaluate the app through the “mHealth App Usability Questionnaire” and additional interviews or questionnaires. Results: Results are expected to be published by December 2023. Conclusions: Pregnant Faster has been designed through iterative cocreation with the target group and health care professionals. With the designed study, we will test Pregnant Faster’s feasibility. If overall user satisfaction and PCC uptake is achieved, the app will be further developed and the cohort will be continued with an additional 400 inclusions to establish effectiveness. International Registered Report Identifier (IRRID): DERR1-10.2196/45293 %M 37556197 %R 10.2196/45293 %U https://www.researchprotocols.org/2023/1/e45293 %U https://doi.org/10.2196/45293 %U http://www.ncbi.nlm.nih.gov/pubmed/37556197 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45007 %T Sexual Health and Drug Use Prevention for Black Girls (The Dreamer Girls Project): Protocol for an Intervention Development %A Opara,Ijeoma %A Gabriel,Cora %A Duran-Becerra,Beatriz %A Bond,Keosha %A Hill,Ashley V %A Hussett-Richardson,Sydney %A Alves,Courtnae %A Kershaw,Trace %+ Yale School of Public Health, 60 College Street Suite 440, New Haven, CT, 06520, United States, 1 203 785 6210, ijeoma.opara@yale.edu %K HIV prevention %K drug use prevention %K Black girls %K youth %K formative %K Black %K girl %K adolescent %K drug abuse %K substance abuse %K HIV %K prevention %K patient education %K education intervention %K sexual transmission %K sexually transmitted %K sexually transmitted disease %K STD %K sexually transmitted infection %K STI %K sexual health %K health promotion %K ethnic %K minority %D 2023 %7 9.8.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Substance use among adolescent girls is associated with numerous risk characteristics, including engaging in sexual risk behaviors, which can lead to HIV and sexually transmitted infection (STI) diagnoses. This is an important phenomenon to target as there is a significant race-gendered paradox that occurs when Black girls use and misuse drugs. When misuse occurs among this group, they are more likely to face harsher consequences and worse health outcomes than boys and other ethnic-minority girls. Therefore, there is a need to understand the risk and protective factors of drug use and sexual risk behaviors among Black girls and develop a robust intervention that can cater for this group. Objective: We propose the development of a strengths-based prevention education intervention for Black girls between the ages of 13 and 18 years to promote protective factors. Methods: A sequential, mixed methods study will be conducted, and we will use the first 3 steps of the ADAPT-ITT (assessment, decision, adaptation, production, topical experts, integration, training, testing) framework to begin the development of the intervention. Three aims will be described in this protocol. First, aim 1 is to explore sociocultural risk and protective factors among Black girls between the ages 13 and 18 years in drug use and HIV/STI prevention using focus group methodology and surveys. We will conduct at least 10 focus groups to include up to 75 Black girls or until we reach saturation. Our target sample size for the quantitative portion of the study will be 200 participants. Aim 2 will focus on deciding upon an intervention based on findings from aim 1 and forming a youth advisory board to guide intervention development. Aim 3 will be to conduct a pretest of the intervention with the youth advisory board to determine if the intervention is feasible and will be accepted by Black girls. Results: The study is part of a 2-year research pilot study award from the National Institutes of Mental Health. Data collection for this study began in October 2021. For aim 1, data collection is 95% complete. We expect to complete all data collection for aim 1 on or before May 30, 2023. Study activities for aim 2 are occurring simultaneously as data are being collected and analyzed and will be completed in the summer of 2023. Study activities for aim 3 will begin in the fall of 2023. Conclusions: This study will be one of the few interventions that address both sexual health and drug use together and cater to Black girls. We anticipate that the intervention will be beneficial for Black girls across the nation to work on building culturally appropriate prevention education and building peer social supports, resulting in reduction or delayed substance use and improved sexual health. Trial Registration: ClinicalTrials.gov NCT05014074; https://clinicaltrials.gov/ct2/show/NCT05014074 International Registered Report Identifier (IRRID): DERR1-10.2196/45007 %M 37556188 %R 10.2196/45007 %U https://www.researchprotocols.org/2023/1/e45007 %U https://doi.org/10.2196/45007 %U http://www.ncbi.nlm.nih.gov/pubmed/37556188 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e47158 %T The Impact of a Mobile Support Group on Distress and Physical Activity in Breast Cancer Survivors: Randomized, Parallel-Group, Open-Label, Controlled Trial %A Jung,Miyeon %A Lee,Sae Byul %A Lee,Jong Won %A Park,Yu Rang %A Chung,Haekwon %A Min,Yul Ha %A Park,Hye Jin %A Lee,Minsun %A Chung,Seockhoon %A Son,Byung Ho %A Ahn,Sei-Hyun %A Chung,Il Yong %+ Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Olympicro 88 43gil, Seoul, 05505, Republic of Korea, 82 2 3010 3998, doorkeeper1@gmail.com %K breast neoplasms %K mental distress %K mobile apps %K mobile health intervention %K mobile phone %K physical activity %K randomized controlled trial %K RCT %K support group %K survivorship %K telemedicine %D 2023 %7 7.8.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: While mobile health apps have demonstrated their potential in revolutionizing health behavior changes, the impact of a mobile community built on these apps on the level of physical activity and mental well-being in cancer survivors remains unexplored. Objective: In this randomized controlled trial, we examine the effects of participation in a mobile health community specifically designed for breast cancer survivors on their physical activity levels and mental distress. Methods: We performed a single-center, randomized, parallel-group, open-label, controlled trial. This trial enrolled women between 20 and 60 years of age with stage 0 to III breast cancer, an Eastern Cooperative Oncology Group performance status of 0, and the capability of using their own smartphone apps. From January 7, 2019, to April 17, 2020, a total of 2,616 patients were consecutively screened for eligibility after breast cancer surgery. Overall, 202 patients were enrolled in this trial, and 186 patients were randomly assigned (1:1) to either the intervention group (engagement in a mobile peer support community using an app for tracking steps; n=93) or the control group (using the app for step tracking only; n=93) with a block size of 10 without stratification. The mobile app provides a visual interface of daily step counts, while the community function also provides rankings among its members and regular notifications encouraging physical activity. The primary end point was the rate of moderate to severe distress for the 24-week study period, measured through an app-based survey using the Distress Thermometer. The secondary end point was the total weekly steps during the 24-week period. Results: After excluding dropouts, 85 patients in the intervention group and 90 patients in the control group were included in the analysis. Multivariate analyses showed that patients in the intervention group had a significantly lower degree of moderate to severe distress (B=–0.558; odds ratio 0.572; P<.001) and a higher number of total weekly step counts (B=0.125; rate ratio 1.132; P<.001) during the 24-week period. Conclusions: Engagement in a mobile app–based patient community was effective in reducing mental distress and increasing physical activity in breast cancer survivors. Trial Registration: ClinicalTrials.gov NCT03783481; https://classic.clinicaltrials.gov/ct2/show/NCT03783481 %M 37549004 %R 10.2196/47158 %U https://www.jmir.org/2023/1/e47158 %U https://doi.org/10.2196/47158 %U http://www.ncbi.nlm.nih.gov/pubmed/37549004 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46839 %T A Novel Mobile App for Personalized Dietary Advice Leveraging Persuasive Technology, Computer Vision, and Cloud Computing: Development and Usability Study %A Guan,Vivienne %A Zhou,Chenghuai %A Wan,Hengyi %A Zhou,Rengui %A Zhang,Dongfa %A Zhang,Sihan %A Yang,Wangli %A Voutharoja,Bhanu Prakash %A Wang,Lei %A Win,Khin Than %A Wang,Peng %+ School of Medical, Indigenous and Health Sciences, Faculty of Science, Medicine and Health, University of Wollongong, Bldg 41 Northfields Ave, Wollongong, New South Wales, 2522, Australia, 61 2 4221 3555, vguan@uow.edu.au %K food %K diet %K mobile health %K mHealth %K persuasive technology %K gamification %K computer vision %K cloud computing %K design science research %K mobile phone %D 2023 %7 7.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The Australian Dietary Guidelines (ADG) translate the best available evidence in nutrition into food choice recommendations. However, adherence to the ADG is poor in Australia. Given that following a healthy diet can be a potentially cost-effective strategy for lowering the risk of chronic diseases, there is an urgent need to develop novel technologies for individuals to improve their adherence to the ADG. Objective: This study describes the development process and design of a prototype mobile app for personalized dietary advice based on the ADG for adults in Australia, with the aim of exploring the usability of the prototype. The goal of the prototype was to provide personalized, evidence-based support for self-managing food choices in real time. Methods: The guidelines of the design science paradigm were applied to guide the design, development, and evaluation of a progressive web app using Amazon Web Services Elastic Compute Cloud services via iterations. The food layer of the Nutrition Care Process, the strategies of cognitive behavioral theory, and the ADG were translated into prototype features guided by the Persuasive Systems Design model. A gain-framed approach was adopted to promote positive behavior changes. A cross-modal image-to-recipe retrieval model under an Apache 2.0 license was deployed for dietary assessment. A survey using the Mobile Application Rating Scale and semistructured in-depth interviews were conducted to explore the usability of the prototype through convenience sampling (N=15). Results: The prominent features of the prototype included the use of image-based dietary assessment, food choice tracking with immediate feedback leveraging gamification principles, personal goal setting for food choices, and the provision of recipe ideas and information on the ADG. The overall prototype quality score was “acceptable,” with a median of 3.46 (IQR 2.78-3.81) out of 5 points. The median score of the perceived impact of the prototype on healthy eating based on the ADG was 3.83 (IQR 2.75-4.08) out of 5 points. In-depth interviews identified the use of gamification for tracking food choices and innovation in the image-based dietary assessment as the main drivers of the positive user experience of using the prototype. Conclusions: A novel evidence-based prototype mobile app was successfully developed by leveraging a cross-disciplinary collaboration. A detailed description of the development process and design of the prototype enhances its transparency and provides detailed insights into its creation. This study provides a valuable example of the development of a novel, evidence-based app for personalized dietary advice on food choices using recent advancements in computer vision. A revised version of this prototype is currently under development. %M 37549000 %R 10.2196/46839 %U https://formative.jmir.org/2023/1/e46839 %U https://doi.org/10.2196/46839 %U http://www.ncbi.nlm.nih.gov/pubmed/37549000 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43271 %T Opportunities for the Implementation of a Digital Mental Health Assessment Tool in the United Kingdom: Exploratory Survey Study %A Spadaro,Benedetta %A Martin-Key,Nayra A %A Funnell,Erin %A Benáček,Jiří %A Bahn,Sabine %+ Cambridge Centre for Neuropsychiatric Research, Department of Chemical Engineering, University of Cambridge, Philippa Fawcett Drive, Cambridge, CB3 0AS, United Kingdom, 44 1223 334151, sb209@cam.ac.uk %K assessment %K digital mental health %K development %K implementation %K mental health %K provision %K support %K mobile phone %D 2023 %7 7.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Every year, one-fourth of the people in the United Kingdom experience diagnosable mental health concerns, yet only a proportion receive a timely diagnosis and treatment. With novel developments in digital technologies, the potential to increase access to mental health assessments and triage is promising. Objective: This study aimed to investigate the current state of mental health provision in the United Kingdom and understand the utility of, and interest in, digital mental health technologies. Methods: A web-based survey was generated using Qualtrics XM. Participants were recruited via social media. Data were explored using descriptive statistics. Results: The majority of the respondents (555/618, 89.8%) had discussed their mental health with a general practitioner. More than three-fourths (503/618, 81.4%) of the respondents had been diagnosed with a mental health disorder, with the most common diagnoses being depression and generalized anxiety disorder. Diagnostic waiting times from first contact with a health care professional varied by diagnosis. Neurodevelopmental disorders (30/56, 54%), bipolar disorder (25/52, 48%), and personality disorders (48/101, 47.5%) had the longest waiting times, with almost half (103/209, 49.3%) of these diagnoses taking >6 months. Participants stated that waiting times resulted in symptoms worsening (262/353, 74.2%), lower quality of life (166/353, 47%), and the necessity to seek emergency care (109/353, 30.9%). Of the 618 participants, 386 (62.5%) stated that they felt that their mental health symptoms were not always taken seriously by their health care provider and 297 (48.1%) were not given any psychoeducational information. The majority of the respondents (416/595, 77.5%) did not have the chance to discuss mental health support and treatment options. Critically, 16.1% (96/595) did not find any treatment or support provided at all helpful, with 63% (48/76) having discontinued treatment with no effective alternatives. Furthermore, 88.3% (545/617) of the respondents) had sought help on the web regarding mental health symptoms, and 44.4% (272/612) had used a web application or smartphone app for their mental health. Psychoeducation (364/596, 61.1%), referral to a health care professional (332/596, 55.7%), and symptom monitoring (314/596, 52.7%) were the most desired app features. Only 6.8% (40/590) of the participants said that they would not be interested in using a mental health assessment app. Respondents were the most interested to receive an overall severity score of their mental health symptoms (441/546, 80.8%) and an indication of whether they should seek mental health support (454/546, 83.2%). Conclusions: Key gaps in current UK mental health care provision are highlighted. Assessment and treatment waiting times together with a lack of information regarding symptoms and treatment options translated into poor care experiences. The participants’ responses provide proof-of-concept support for the development of a digital mental health assessment app and valuable recommendations regarding desirable app features. %M 37549003 %R 10.2196/43271 %U https://formative.jmir.org/2023/1/e43271 %U https://doi.org/10.2196/43271 %U http://www.ncbi.nlm.nih.gov/pubmed/37549003 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44638 %T Mindfulness-Based Mobile Apps and Their Impact on Well-Being in Nonclinical Populations: Systematic Review of Randomized Controlled Trials %A Schwartz,Katrin %A Ganster,Fabienne Marie %A Tran,Ulrich S %+ Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, Vienna, 1010, Austria, 43 4277471 ext 19, ulrich.tran@univie.ac.at %K mindfulness %K well-being %K mobile app %K systematic review %K randomized controlled trial %K RCT %K mobile phone %D 2023 %7 4.8.2023 %9 Review %J J Med Internet Res %G English %X Background: Mindfulness-based mobile apps have become popular tools for enhancing well-being in today’s fast-paced world. Their ability to reduce geographical, financial, and social barriers makes them a promising alternative to traditional interventions. Objective: As most available apps lack a theoretical framework, this review aimed to evaluate their effectiveness and assess their quality. We expected to find small sample sizes, high dropout rates, and small effect sizes in the included studies. Methods: A systematic literature search was conducted using PsycInfo, PsycNet, PubMed, an institutional search engine (u:search), and Google Scholar. Randomized controlled trials assessing the impact of mobile mindfulness apps on well-being in nonclinical samples were included. Study selection, risk of bias (using the version 2 of the Cochrane risk-of-bias tool for randomized trials), and reporting quality (using selected CONSORT [Consolidated Standards of Reporting Trials] statement criteria) assessments were performed by 2 authors independently and discussed until a consensus was reached. Results: The 28 included randomized controlled trials differed in well-being measures, apps, and intervention duration (7 to 56 days; median duration 28 days). A wide range of sample sizes (12 to 2282; median 161) and attrition rates (0% to 84.7%; median rate 23.4%) were observed. Most studies (19/28, 68%) reported positive effects on at least one aspect of well-being. The effects were presented using different metrics but were primarily small or small to medium in size. Overall risk of bias was mostly high. Conclusions: The wide range of sample sizes, attrition rates, and intervention periods and the variation in well-being measures and mobile apps contributed to the limited comparability of the studies. Although most studies (16/28, 57%) reported small or small to medium effects for at least one well-being outcome, this review demonstrates that the generalizability of the results is limited. Further research is needed to obtain more consistent conclusions regarding the impact of mindfulness-based mobile apps on well-being in nonclinical populations. %M 37540550 %R 10.2196/44638 %U https://www.jmir.org/2023/1/e44638 %U https://doi.org/10.2196/44638 %U http://www.ncbi.nlm.nih.gov/pubmed/37540550 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 10 %N %P e46217 %T Improving Home-Based Scoliosis Therapy: Findings From a Web-Based Survey %A Günther,Florian %A Schober,Fabian %A Hunger,Sandra %A Schellnock,Julia %A Derlien,Steffen %A Schleifenbaum,Stefan %A Drossel,Welf-Guntram %A Heyde,Christoph-Eckhard %+ Department of Biomechatronics, Fraunhofer Institute for Machine Tools and Forming Technology IWU, Nöthnitzer Straße 44, Dresden, 01187, Germany, 49 351 4772 2160, florian.guenther@iwu.fraunhofer.de %K scoliosis therapy %K Schroth therapy %K home-based exercise %K home program %K physiotherapeutic scoliosis-specific exercises (PSSE) %K adherence %K assistive devices %K exercise system %K digital tools %K eHealth %D 2023 %7 4.8.2023 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: Conservative scoliosis therapy in the form of assisted physiotherapeutic scoliosis exercises is supplemented by self-contained training at home, depending on the approach (eg, Schroth, the Scientific Exercises Approach to Scoliosis). Complex exercises, lack of awareness of the importance of training, and missing supervision by therapists often lead to uncertainty and reduced motivation, which in turn reduces the success of home-based therapy. Increasing digitalization in the health care sector offers opportunities to close this gap. However, research is needed to analyze the requirements and translate the potential of digital tools into concrete solution concepts. Objective: The aim of this study is to evaluate the potential for optimizing home-based scoliosis therapy in terms of motivation, assistive devices, and digital tools. Methods: In collaboration with the Institute of Physiotherapy at the Jena University Hospital, a survey was initiated to address patients with scoliosis and physical therapists. A digital questionnaire was created for each target group and distributed via physiotherapies, scoliosis forums, the Bundesverband für Skoliose Selbsthilfe e. V. newsletter via a link, and a quick response code. The survey collected data on demographics, therapy, exercise habits, motivation, assistive devices, and digital tools. Descriptive statistics were used for evaluation. Results: Of 141 survey participants, 72 (51.1%; n=62, 86.1%, female; n=10, 13.9%, male) patients with scoliosis with an average age of 40 (SD 17.08) years and 30 scoliosis therapists completed the respective questionnaires. The analysis of home-based therapy showed that patients with scoliosis exercise less per week (2 times or less; 45/72, 62.5%) than they are recommended to do by therapists (at least 3 times; 53/72, 73.6%). Patients indicated that their motivation could be increased by practicing together with friends and acquaintances (54/72, 75%), a supporting therapy device (48/72, 66.7%), or a digital profile (46/72, 63.9%). The most important assistive devices, which are comparatively rarely used in home-based therapy, included balance boards (20/72, 27.8%), wall bars (23/72, 31.9%), mirrors (36/72, 50%), and long bars (40/72, 55.6%). Therapists saw the greatest benefit of digital tools for scoliosis therapy in increasing motivation (26/30, 87%), improving home therapy (25/30, 83%), monitoring therapy progress (25/30, 83%), and demonstrating exercise instructions (24/30, 80%). Conclusions: In this study, we investigated whether there is any potential for improvement in home-based scoliosis therapy. For this purpose, using online questionnaires, we asked patients with scoliosis and therapists questions about the following topics: exercise habits, outpatient and home-based therapy, motivation, supportive devices, and digital tools. The results showed that a lack of motivation, suitable training equipment, and tools for self-control leads to a low training workload. From the perspective of the patients surveyed, this problem can be addressed through community training with friends or acquaintances, a supportive therapy device, and digital elements, such as apps, with training instructions and user profiles. %M 37540557 %R 10.2196/46217 %U https://rehab.jmir.org/2023/1/e46217 %U https://doi.org/10.2196/46217 %U http://www.ncbi.nlm.nih.gov/pubmed/37540557 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42017 %T Assessment of Frailty by the French Version of the Vulnerable Elders Survey-13 on Digital Tablet: Validation Study %A Zolnowski-Kolp,Victoria %A Um Din,Nathavy %A Havreng-Théry,Charlotte %A Pariel,Sylvie %A Veyron,Jacques-Henri %A Lafuente-Lafuente,Carmelo %A Belmin,Joel %+ LivingLab Pratiques en santé dans le grand âge, Hôpital Charles Foix, 7 avenue de la République, Ivry-sur-Seine, 94200, France, 33 0149594565, j.belmin@aphp.fr %K frailty %K Vulnerable Elders Survey-13 (VES-13) %K elderly %K older people %K family caregivers %K French version %K electronic assessment %K digital technology %K digital health %K eHealth %K tablet %K validity %D 2023 %7 2.8.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Frailty assessment is a major issue in geriatric medicine. The Vulnerable Elders Survey-13 (VES-13) is a simple and practical tool that identifies frailty through a 13-item questionnaire completed by older adults or their family caregivers by self-administration (pencil and paper) or by telephone interview. The VES-13 provides a 10-point score that is also a recognized mortality predictor. Objective: This study aims to design an electronic version of the Echelle de Vulnérabilité des Ainés-13, the French version of the VES-13 (eEVA-13) for use on a digital tablet and validate it. Methods: The scale was implemented as a web App in 3 different screens and used on an Android tablet (14.0× 25.6 cm). Participants were patients attending the outpatient clinic of a French geriatric hospital or hospitalized in a rehabilitation ward and family caregivers of geriatric patients. They completed the scale twice, once by a reference method (self-administered questionnaire or telephone interview) and once by eEVA-13 using the digital tablet. Agreement for diagnosis of frailty was assessed with the κ coefficient, and scores were compared by Bland and Altman plots and interclass correlation coefficients. User experience was assessed by a self-administered questionnaire. Results: In total, 86 participants, including 40 patients and 46 family caregivers, participated in the study. All family caregivers had previously used digital devices, while 13 (32.5%) and 10 (25%) patients had no or infrequent use of them previously. We observed no failure to complete the eEVA-13, and 70% of patients (28/40) and no family caregivers needed support to complete the eEVA-13. The agreement between the eEVA-13 and the reference method for the diagnosis of frailty was excellent (κ=0.92) with agreement in 83 cases and disagreement in 3 cases. The mean difference between the scores provided by the 2 scales was 0.081 (95% CI–1.263 to 1.426). Bland and Altman plots showed a high level of agreement between the eEVA-13 and the reference methods and interclass correlation coefficient value was 0.997 (95% CI 0.994-0.998) for the paper and tablet group and 0.977 (95% CI 0.957-0.988) for the phone and tablet groups. The tablet assessment was found to be easy to use by 77.5% (31/40) of patients and by 96% (44/46) of caregivers. Finally, 85% (39/46) of family caregivers and 50% (20/40) of patients preferred the eEVA-13 to the original version. Conclusions: The eEVA-13 is an appropriate digital tool for diagnosing frailty and can be used by older adults and their family caregivers. The scores obtained with eEVA-13 are highly correlated with those obtained with the original version. The use of health questionnaires on digital tablets is feasible in frail and very old patients, although some patients may need help to use them. %M 37531175 %R 10.2196/42017 %U https://www.jmir.org/2023/1/e42017 %U https://doi.org/10.2196/42017 %U http://www.ncbi.nlm.nih.gov/pubmed/37531175 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46606 %T An SMS Text Message–Based Type 2 Diabetes Prevention Program for Hispanic Adolescents With Obesity: Qualitative Co-Design Process %A Soltero,Erica %A Lopez,Callie %A Mihail,Sandra %A Hernandez,Ayleen %A Musaad,Salma M %A O'Connor,Teresia M %A Thompson,Debbe %+ USDA/ARS Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine, 1100 Bates Str, Houston, TX, 77030, United States, 1 713 798 3802, soltero@bcm.edu %K Hispanic health %K adolescents %K digital health %K physical activity %K sleep %K type 2 diabetes %K mobile phone %K smartphone %D 2023 %7 2.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: SMS text message–based interventions are a promising approach for reaching and engaging high-risk youths, such as Hispanic adolescents with obesity, in health promotion and disease prevention opportunities. This is particularly relevant, given that SMS text messaging is widely accessible and available and that adolescents are frequent texters. Including youths in the development of SMS text message content can lead to more acceptable and relevant messaging; however, few studies include this group as cocollaborators. Objective: This study aimed to use a co-design process to inform the development of SMS text messages that promote healthy physical activity (PA) and sleep behaviors among Hispanic adolescents with obesity. Methods: The co-design framework uses multiple methods across several phases. Self-determination theory and a literature review of SMS text message–based interventions guided the background and research phases. In the co-design phase, Hispanic adolescents (n=20) completed in-depth interviews to identify barriers and facilitators of PA and sleep, preferences for ways to emphasize key self-determination theory constructs (autonomy, competence, and relatedness), and suggestions for making SMS text message content engaging. In the design and content phase, interview findings were used to develop initial SMS text messages, which were then evaluated in the early evaluation phase by experts (n=6) and adolescents (n=6). Feedback from these panels was integrated into the SMS text message content during refinement. Results: The background phase revealed that few SMS text message–based interventions have included Hispanic adolescents. Common barriers and facilitators of activity and sleep as well as preferences for ways in which SMS text messages could provide autonomy, competence, and relatedness support were identified in the co-design phase. The youths also wanted feedback about goal attainment. Suggestions to make SMS text messages more engaging included using emojis, GIFs, and media. This information informed an initial bank of SMS text messages (N=116). Expert review indicated that all (116/116, 100%) SMS text messages were age and culturally appropriate; however, some (21/116, 18.1%) did not adequately address youth-identified barriers and facilitators of PA and sleep, whereas others (30/116, 25.9%) were not theoretically adherent. Adolescents reported that SMS text messages were easy to understand (116/116, 100%), provided the support needed for behavior change (103/116, 88.8%), and used mostly acceptable language (84/116, 72.4%). Feedback was used to refine and develop the final bank of 125 unique text messages. Conclusions: Using a co-design process, a theoretically grounded, appealing, and relevant bank of SMS text messages promoting healthy PA and sleep behaviors to adolescents was developed. The SMS text messages will be further evaluated in a pilot study to assess feasibility, acceptability, and preliminary efficacy. The co-design process used in this study provides a framework for future studies aimed at developing SMS text message–based strategies among high-risk adolescents. International Registered Report Identifier (IRRID): RR2-10.1016/j.cct.2023.107117 %M 37531191 %R 10.2196/46606 %U https://formative.jmir.org/2023/1/e46606 %U https://doi.org/10.2196/46606 %U http://www.ncbi.nlm.nih.gov/pubmed/37531191 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45804 %T Internet-Delivered Cognitive Behavioral Treatment for Chronic Pain in Adolescent Survivors of Childhood Cancer: Protocol for a Single-Group Feasibility Trial %A Patton,Michaela %A Carlson,Linda E %A Noel,Melanie %A Palermo,Tonya %A Forster,Victoria %A Cho,Sara %A Schulte,Fiona %+ Department of Psychology, University of Calgary, 2500 University Dr NW, Calgary, AB, T2N 1N4, Canada, 1 403 698 8103, fsmschul@ucalgary.ca %K pediatric oncology %K chronic pain %K cognitive behavioral therapy %K eHealth %K intervention %K late effects %K cancer survivorship %K pediatric cancer %K youth %K mental health %K psychological difficulties %K chronic health conditions %K pain management %K intervention %K cancer survivor %D 2023 %7 1.8.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: There are over 500,000 survivors of childhood cancer in North America alone. One in 4 survivors experiences chronic pain after treatment has been completed. Youths with chronic pain report increased anxiety, depression, activity limitations, and sleep disturbances. An 8-week web-based cognitive behavioral treatment for chronic pain (Web-Based Management of Adolescent Pain [WebMAP]) has demonstrated a reduction in pain in youths but has not yet been explored in survivors. Objective: The objectives of this study are to (1) test the feasibility and acceptability of WebMAP for a sample of survivors with chronic pain and their parents; (2) assess the acceptability of WebMAP using qualitative interviews; (3) assess WebMAP’s effect on activity limitations, pain intensity, depression and anxiety symptoms, and sleep disturbances; and (4) assess WebMAP’s effect on parent pain catastrophizing and parental response to their child’s pain. Methods: A single-arm mixed methods pre-post intervention study design will be used. Participants will be 34 survivors and at least one of their parents or caregivers. Inclusion criteria are (1) a cancer history, (2) current age of 10-17 years, (3) >2 years post treatment or >5 years post diagnosis, (4) pain present over prior 3 months impairing >1 area of daily life and occurring >1 time per month, and (5) computer access with broadband internet. Survivors will complete a pretreatment questionnaire, which will include the following: the Child Activity Limitations Interview, the pain intensity Numerical Rating Scale, Patient-Reported Outcomes Measurement Information System (PROMIS)–Pain Interference, Anxiety, Depression, Insomnia Severity Index, and Adolescent Sleep Wake Scale. Parents will complete the Pain Catastrophizing Scale–Parent Version and the Adult Responses to Child Symptoms. Upon completion of pretreatment questionnaires (T0), survivors will begin WebMAP. After the 8-week intervention, survivors will complete the same measures (T1), and at 3-month follow-up (T2). Posttreatment interviews will be conducted to determine acceptability. Feasibility will be assessed via recruitment and retention rates. Treatment engagement will be measured by number of modules completed. Pre-post outcome data will be assessed using linear mixed models. Qualitative data will be analyzed using thematic analysis. Patient partners will be involved in study design, recruitment, interpretation of results, and knowledge translation. Results: This study has been funded in January 2022. Data collection started in May 2022 and is projected to end in August 2023. We have enrolled 10 participants as of December 2022. Conclusions: Investigating whether WebMAP is useful to survivors will be an important step in improving pain management in this population. Trial Registration: ClinicalTrials.gov NCT05241717; https://clinicaltrials.gov/ct2/show/NCT05241717 International Registered Report Identifier (IRRID): DERR1-10.2196/45804 %M 37526959 %R 10.2196/45804 %U https://www.researchprotocols.org/2023/1/e45804 %U https://doi.org/10.2196/45804 %U http://www.ncbi.nlm.nih.gov/pubmed/37526959 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46621 %T Investigating Factors Influencing Medical Practitioners’ Resistance to and Adoption of Internet Hospitals in China: Mixed Methods Study %A Deng,Wenhao %A Yang,Tianan %A Deng,Jianwei %A Liu,Ran %A Sun,Xueqin %A Li,Gang %A Wen,Xinmei %+ School of Management and Economics, Beijing Institute of Technology, 5 South Zhongguancun Street, Beijing, 100081, China, 86 10 6893 8057, dengjianwei2006@163.com %K internet hospital %K conservation of resource theory %K medical practitioner %K Unified Theory of Acceptance and Use of Technology %K technostress %K resistance to change %K behavioral intention to use %D 2023 %7 31.7.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: The swift shift toward internet hospitals has relied on the willingness of medical practitioners to embrace new systems and workflows. Low engagement or acceptance by medical practitioners leads to difficulties in patient access. However, few investigations have focused on barriers and facilitators of adoption of internet hospitals from the perspective of medical practitioners. Objective: This study aims to identify both enabling and inhibiting predictors associated with resistance and behavioral intentions of medical practitioners to use internet hospitals by combining the conservation of resources theory with the Unified Theory of Acceptance and Use of Technology and technostress framework. Methods: A mixed methods research design was conducted to qualitatively identify the factors that enable and inhibit resistance and behavioral intention to use internet hospitals, followed by a quantitative survey-based study that empirically tested the effects of the identified factors. The qualitative phase involved conducting in-depth interviews with 16 experts in China from June to August 2022. Thematic analysis was performed using the qualitative data analysis software NVivo version 10 (QSR International). On the basis of the findings and conceptual framework gained from the qualitative interviews, a cross-sectional, anonymous, web-based survey of 593 medical practitioners in 28 provincial administrative regions of China was conducted. The data collected were analyzed using the partial least squares method, with the assistance of SPSS 27.0 (IBM Corp) and Mplus 7.0 (Muthen and Muthen), to measure and validate the proposed model. Results: On the basis of qualitative results, this study identified 4 facilitators and inhibitors, namely performance expectancy, social influence, work overload, and role ambiguity. Of the 593 medical practitioners surveyed in the quantitative research, most were female (n=364, 61.4%), had a middle title (n=211, 35.6%) or primary title (n=212, 35.8%), and had an average use experience of 6 months every year. By conducting structural equation modeling, we found that performance expectancy (β=−.55; P<.001) and work overload (β=.16; P=.005) had the most significant impact on resistance to change. Resistance to change fully mediated the influence of performance expectancy and partially mediated the influences of social influence (variance accounted for [VAF]=43.3%; P=.002), work overload (VAF=37.2%; P=.03), and role ambiguity (VAF=12.2%; P<.001) on behavioral intentions to use internet hospitals. In addition, this study found that the sex, age, professional title, and use experience of medical practitioners significantly moderated the aforementioned influencing mechanisms. Conclusions: This study investigated the factors that facilitate or hinder medical practitioners’ resistance to change and their behavioral intentions to use internet hospitals. The findings suggest that policy makers avoid the resistance and further promote the adoption of internet hospitals by ensuring performance expectancy and social influence and eliminating work overload and role ambiguity. %M 37523226 %R 10.2196/46621 %U https://www.jmir.org/2023/1/e46621 %U https://doi.org/10.2196/46621 %U http://www.ncbi.nlm.nih.gov/pubmed/37523226 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45111 %T Effectiveness of eHealth Smoking Cessation Interventions: Systematic Review and Meta-Analysis %A Fang,Yichen E %A Zhang,Zhixian %A Wang,Ray %A Yang,Bolu %A Chen,Chen %A Nisa,Claudia %A Tong,Xin %A Yan,Lijing L %+ Global Health Research Center, Duke Kunshan University, 3rd floor, Academic Building, Kunshan, 215316, China, 86 0 512 5777 9988, lijing.yan@duke.edu %K smoking cessation %K systematic review %K meta-analysis %K electronic health %K mobile health %K eHealth %K smoking %K development %K technology-assisted %K effectiveness %K screening %K data extraction %K user %K design %K mobile phone %D 2023 %7 28.7.2023 %9 Review %J J Med Internet Res %G English %X Background: Rapid advancements in eHealth and mobile health (mHealth) technologies have driven researchers to design and evaluate numerous technology-based interventions to promote smoking cessation. The evolving nature of cessation interventions emphasizes a strong need for knowledge synthesis. Objective: This systematic review and meta-analysis aimed to summarize recent evidence from randomized controlled trials regarding the effectiveness of eHealth-based smoking cessation interventions in promoting abstinence and assess nonabstinence outcome indicators, such as cigarette consumption and user satisfaction, via narrative synthesis. Methods: We searched for studies published in English between 2017 and June 30, 2022, in 4 databases: PubMed (including MEDLINE), PsycINFO, Embase, and Cochrane Library. Two independent reviewers performed study screening, data extraction, and quality assessment based on the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) framework. We pooled comparable studies based on the population, follow-up time, intervention, and control characteristics. Two researchers performed an independent meta-analysis on smoking abstinence using the Sidik-Jonkman random-effects model and log risk ratio (RR) as the effect measurement. For studies not included in the meta-analysis, the outcomes were narratively synthesized. Results: A total of 464 studies were identified through an initial database search after removing duplicates. Following screening and full-text assessments, we deemed 39 studies (n=37,341 participants) eligible for this review. Of these, 28 studies were shortlisted for meta-analysis. According to the meta-analysis, SMS or app text messaging can significantly increase both short-term (3 months) abstinence (log RR=0.50, 95% CI 0.25-0.75; I2=0.72%) and long-term (6 months) abstinence (log RR=0.77, 95% CI 0.49-1.04; I2=8.65%), relative to minimal cessation support. The frequency of texting did not significantly influence treatment outcomes. mHealth apps may significantly increase abstinence in the short term (log RR=0.76, 95% CI 0.09-1.42; I2=88.02%) but not in the long term (log RR=0.15, 95% CI −0.18 to 0.48; I2=80.06%), in contrast to less intensive cessation support. In addition, personalized or interactive interventions showed a moderate increase in cessation for both the short term (log RR=0.62, 95% CI 0.30-0.94; I2=66.50%) and long term (log RR=0.28, 95% CI 0.04-0.53; I2=73.42%). In contrast, studies without any personalized or interactive features had no significant impact. Finally, the treatment effect was similar between trials that used biochemically verified or self-reported abstinence. Among studies reporting outcomes besides abstinence (n=20), a total of 11 studies reported significantly improved nonabstinence outcomes in cigarette consumption (3/14, 21%) or user satisfaction (8/19, 42%). Conclusions: Our review of 39 randomized controlled trials found that recent eHealth interventions might promote smoking cessation, with mHealth being the dominant approach. Despite their success, the effectiveness of such interventions may diminish with time. The design of more personalized interventions could potentially benefit future studies. Trial Registration: PROSPERO CRD42022347104; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=347104 %M 37505802 %R 10.2196/45111 %U https://www.jmir.org/2023/1/e45111 %U https://doi.org/10.2196/45111 %U http://www.ncbi.nlm.nih.gov/pubmed/37505802 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43493 %T Using a Geosocial Networking App to Investigate New HIV Infections and Related Risk Factors Among Student and Nonstudent Men Who Have Sex With Men in Chengdu, China: Open Cohort Study %A Dai,Zhen %A Mi,Guodong %A Yu,Fei %A Chen,Guodong %A Wang,Xiaodong %A He,Qinying %+ Department of Sexually Transmitted Disease, AIDS Prevention and Control, Chengdu Center for Disease Control and Prevention, Longxiang Road 4, Wuhou District, Chengdu, 610041, China, 86 028 87033114, 78004693@qq.com %K geosocial networking app %K GSN app %K young men who have sex with men %K MSM %K HIV %K incidence %K risk factors %K cohort study %K smartphone %K mobile phone %D 2023 %7 28.7.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: In China, condomless sex among men who have sex with men (MSM) is the primary route of HIV infection in young people. Chengdu is a hotspot for reported HIV cases among young people nationwide. Extensive use of geosocial networking (GSN) smartphone apps has dramatically changed the pattern of sexual behavior among young MSM (YMSM). However, data on HIV incidence and the risk behavior of YMSM using the GSN app are still obscure. Objective: This study aims to analyze and understand the HIV incidence and its risk factors among YMSM using GSN apps in Chengdu, China. Methods: An open cohort study was conducted among YMSM aged 18-24 years through a gay GSN smartphone app in Chengdu, China, from July 2018 to December 2020. Every participant completed a web-based questionnaire on sociodemographic characteristics, sexual behaviors, and other related statuses; made a reservation for a web-based HIV testing; and then voluntarily got tested at the designated testing site. At least one additional HIV test was taken via the app during the study period, and participants were evaluated at the end of the study or at the time of HIV seroconversion. By dividing the sum of the observed HIV seroconversions by the observed person-years, HIV incidence was calculated and compared between the student and nonstudent MSM. Univariate and multivariate (Cox proportional hazards regression) analyses were used to discuss the risk factors for new HIV infections. Results: In the study cohort, 24 seroconversions occurred among 625 YMSM who took at least two HIV tests through the app during the study period, contributing to 505 observed person-years. The HIV incidence rate per 100 person-years was 4.75 (95% CI 2.89-6.61) among all MSM, 3.60 (95% CI 1.27-5.93) among student MSM, and 5.88 (95% CI 2.97-8.79) among nonstudent MSM. In addition, the HIV incidence per 100 person-years was 11.11 (95% CI 4.49-17.73) among those who had resided in the area for 6 months or less and 7.14 (95% CI 1.52-12.77) among those with senior high school or less education. Two or more sexual partners (adjusted hazards ratio [HR] 3.63, 95% CI 1.08-12.23) in the preceding 6 months was a risk factor for new HIV infections. Consistent condom use for anal sex (adjusted HR 0.38, 95% CI 0.16-0.88) and insertive anal sex only (adjusted HR 0.10, 95% CI 0.01-0.75) in the preceding 6 months were protective factors for new HIV infections. Conclusions: The rate of new HIV infections among YMSM who actively used GSN smartphone apps was high, especially among migrant nonstudent MSM. Targeted interventions on GSN smartphone apps should be implemented to provide demand-adapted prevention and services to reduce the threat of HIV. %M 37505891 %R 10.2196/43493 %U https://www.jmir.org/2023/1/e43493 %U https://doi.org/10.2196/43493 %U http://www.ncbi.nlm.nih.gov/pubmed/37505891 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47877 %T Promoting Healthy Behaviors Among Adolescents and Young Adults With Intellectual Disability: Protocol for Developing a Digital Intervention With Co-Design Workshops %A Müssener,Ulrika %A Henriksson,Pontus %A Gustavsson,Catharina %A Henriksson,Hanna %A Tyrberg,Mårten J %A Johansson,Stefan %A Alfredsson Ågren,Kristin %+ Department of Health, Medicine, and Caring Sciences, Linköping University, SE-581 85, Linköping, 58577, Sweden, 46 732702426, ulrika.mussener@liu.se %K intellectual disability %K lifestyle behavior %K eHealth %K co-design %K digital intervention %K lifestyle %K adolescents %K young adult %K healthy diet %D 2023 %7 28.7.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Intellectual disability (ID) is a neurodevelopmental disorder associated with a poorer health profile and higher mortality. Young people with ID have more sedentary lifestyles than their typically developing peers. Consequently, this group is at significant risk of developing lifestyle diseases (ie, noncommunicable diseases) later in life. Increasing physical activity and eating a healthier diet have been argued to be effective ways to improve the health of adolescents and young adults with ID. Digital interventions are a viable option for improving health behaviors. Objective: This research protocol describes a co-design approach using workshops to develop a digital intervention that promotes healthy behaviors, including increasing physical activity and eating a healthier diet, among adolescents and young adults with ID. Methods: A participatory design using a co-design approach will be applied as a strategy to include potential users of the digital intervention and other stakeholders in the research process, comprising research design, data collection, and data analysis. A total of 7 to 10 workshops will be conducted aimed at developing a digital intervention and will include procedures for assessing needs; facilitators and barriers to health promotion; physical, mental, and social well-being; participation; and relationships. The workshops will include 12 to 18 stakeholders with experience of clinical practice and research related to young people with ID, including relatives, as well as adolescents and young adults (aged 16-25 years) with mild to moderate ID. Participants will perform a mixture of individual and group work using whiteboards, sticky notes, felt-tip pens, cards, balls, stickers, and wireframe templates. Data analysis will take place concurrently with data collection as an iterative process. Transcribed data from the audio and video recordings of the groups’ discussions will be analyzed following a qualitative methodological procedure. Results: This study protocol provides a systematic record of the scientific methodologies used when developing the digital intervention and provides insights into the potential practical solutions and challenges when following a co-design approach in which relatives and professionals, as well as adolescents and young adults with ID, are included as research partners. Recruitment of participants started in April 2023. Data collection, analysis, and reporting will be completed in December 2023. Conclusions: This study will explore the effectiveness of workshops at gathering rich, reliable, and valid data in a co-design approach with participants. The results will provide increased knowledge in how to use technology to develop novel, evidence-based, and scalable interventions that adolescents and young adults with ID can and want to use to motivate physical activity and a healthier diet. The project will provide a simple and cognitively accessible digital solution for promoting lifestyle behaviors tailored to the needs of adolescents and young adults with ID. International Registered Report Identifier (IRRID): PRR1-10.2196/47877 %M 37505807 %R 10.2196/47877 %U https://www.researchprotocols.org/2023/1/e47877 %U https://doi.org/10.2196/47877 %U http://www.ncbi.nlm.nih.gov/pubmed/37505807 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44079 %T The Effectiveness and Cost-Effectiveness of a Universal Digital Parenting Intervention Designed and Implemented During the COVID-19 Pandemic: Evidence From a Rapid-Implementation Randomized Controlled Trial Within a Cohort %A Palmer,Melanie %A Beckley-Hoelscher,Nicholas %A Shearer,James %A Kostyrka-Allchorne,Katarzyna %A Robertson,Olly %A Koch,Marta %A Pearson,Oliver %A Slovak,Petr %A Day,Crispin %A Byford,Sarah %A Goldsmith,Kimberley %A Waite,Polly %A Creswell,Cathy %A Sonuga-Barke,Edmund J S %+ Institute of Psychiatry, Psychology & Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, United Kingdom, 44 0207 848 0269, edmund.sonuga-barke@kcl.ac.uk %K parenting %K intervention %K digital application %K randomized controlled trial %K COVID-19 pandemic %K mobile phone %D 2023 %7 27.7.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Children’s conduct and emotional problems increased during the COVID-19 pandemic. Objective: We tested whether a smartphone parenting support app, Parent Positive, developed specifically for this purpose, reversed these effects in a cost-effective way. Parent Positive includes 3 zones. Parenting Boosters (zone 1) provided content adapted from standard face-to-face parent training programs to tackle 8 specific challenges identified by parents and parenting experts as particularly relevant for parents during the pandemic. The Parenting Exchange (zone 2) was a parent-to-parent and parent-to-expert communication forum. Parenting Resources (zone 3) provided access to existing high-quality web-based resources on a range of additional topics of value to parents (eg, neurodevelopmental problems, diet, and sleep). Methods: Supporting Parents And Kids Through Lockdown Experiences (SPARKLE), a randomized controlled trial, was embedded in the UK-wide COVID-19: Supporting Parents, Adolescents and Children during Epidemics (Co-SPACE) longitudinal study on families’ mental health during the pandemic. Parents of children aged 4 to 10 years were randomized 1:1 to Parent Positive or follow-up as usual (FAU) between May 19, 2021, and July 26, 2021. Parent Positive provided advice on common parenting challenges and evidence-based web-based resources and facilitated parent-to-parent and expert-to-parent support. Child conduct and emotional problems and family well-being were measured before randomization (T1) and at 1 (T2) and 2 (T3) months after randomization. Service use, costs, and adverse events were measured, along with app use and satisfaction. The primary outcome was T2 parent-reported child conduct problems, which were analyzed using linear mixed regression models. Results: A total of 320 participants were randomized to Parent Positive, and 326 were randomized to FAU. The primary outcome analysis included 79.3% (512/646) of the participants (dropout: 84/320, 26% on Parent Positive and 50/326, 15% on FAU). There were no statistically significant intervention effects on conduct problems at either T2 (standardized effect=−0.01) or T3 (secondary outcome; standardized effect=−0.09) and no moderation by baseline conduct problems. Significant intervention-related reductions in emotional problems were observed at T2 and T3 (secondary outcomes; standardized effect=−0.13 in both cases). Parent Positive, relative to FAU, was associated with more parental worries at T3 (standardized effect=0.14). Few intervention-attributable adverse events were reported. Parent Positive was cost-effective once 4 outliers with extremely high health care costs were excluded. Conclusions: Parent Positive reduced child emotional problems and was cost-effective compared with FAU once outliers were removed. Although small when considered against targeted therapeutic interventions, the size of these effects was in line with trials of nontargeted universal mental health interventions. This highlights the public health potential of Parent Positive if implemented at the community level. Nevertheless, caution is required before making such an interpretation, and the findings need to be replicated in large-scale, whole-community studies. Trial Registration: ClinicalTrials.gov NCT04786080; https://clinicaltrials.gov/ct2/show/NCT04786080 %M 37498669 %R 10.2196/44079 %U https://www.jmir.org/2023/1/e44079 %U https://doi.org/10.2196/44079 %U http://www.ncbi.nlm.nih.gov/pubmed/37498669 %0 Journal Article %@ 2369-3762 %I JMIR Publications %V 9 %N %P e45587 %T Web-Based Learning for General Practitioners and Practice Nurses Regarding Behavior Change: Qualitative Descriptive Study %A Raumer-Monteith,Lauren %A Kennedy,Madonna %A Ball,Lauren %+ Nutrition and Dietetics, School of Health Sciences and Social Work, Griffith University, 1 Parkslands Drive, Gold Coast, 4215, Australia, 61 411747083, lauren.raumer-monteith@outlook.com %K continuing professional development %K continuing medical education %K web-based %K e-learning %K behavior change %K general practitioner %K practice nurse %K nurse %K medical education %K professional development %K general practice %K web-based learning %K remote learning %K adoption %K perspective %K health care professional %D 2023 %7 27.7.2023 %9 Original Paper %J JMIR Med Educ %G English %X Background: Supporting patients to live well by optimizing behavior is a core tenet of primary health care. General practitioners and practice nurses experience barriers in providing behavior change interventions to patients for lifestyle behaviors, including low self-efficacy in their ability to enact change. Web-based learning technologies are readily available for general practitioners and practice nurses; however, opportunities to upskill in behavior change are still limited. Understanding what influences general practitioners’ and practice nurses’ adoption of web-based learning is crucial to enhancing the quality and impact of behavior change interventions in primary health care. Objective: This study aimed to explore general practitioners’ and practice nurses’ perceptions regarding web-based learning to support patients with behavior change. Methods: A qualitative, cross-sectional design was used involving web-based, semistructured interviews with general practitioners and practice nurses in Queensland, Australia. The interviews were recorded and transcribed using the built-in Microsoft Teams transcription software. Inductive coding was used to generate codes from the interview data for thematic analysis. Results: In total, there were 11 participants in this study, including general practitioners (n=4) and practice nurses (n=7). Three themes emerged from the data analysis: (1) reflecting on the provider of the Healthy Lifestyles suite; (2) valuing the web-based learning content and presentation; and (3) experiencing barriers and facilitators to using the Healthy Lifestyles suite. Conclusions: Provider reputation, awareness of availability, resources, content quality, usability, cost, and time influence adoption of web-based learning. Perceived quality is associated with culturally tailored information, resources, a balance of information and interactivity, plain language, user-friendly navigation, appealing visual presentation, communication examples, and simple models. Free web-based learning that features progress saving and module lengths of less than 2 hours alleviate perceived time and cost barriers. Learning providers may benefit by including these features in their future behavior change web-based learning for general practitioners and practice nurses. %M 37498657 %R 10.2196/45587 %U https://mededu.jmir.org/2023/1/e45587 %U https://doi.org/10.2196/45587 %U http://www.ncbi.nlm.nih.gov/pubmed/37498657 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47662 %T Monitoring Cigarette Smoking and Relapse in Young Adults With and Without Remote Biochemical Verification: Randomized Brief Cessation Study %A McClure,Erin A %A Baker,Nathaniel %A Walters,Kyle J %A Tomko,Rachel L %A Carpenter,Matthew J %A Bradley,Elizabeth %A Squeglia,Lindsay M %A Gray,Kevin M %+ Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 67 President St, Charleston, SC, 29425, United States, 1 843 792 7192, mccluree@musc.edu %K technology %K mHealth %K young adults %K cessation %K relapse %K biochemical verification %K cigarette %K smoking %K monitoring %K abstinence %K mobile phone %D 2023 %7 27.7.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Technological advancements to study young adult smoking, relapse, and to deliver interventions remotely offer conceptual appeal, but the incorporation of technological enhancement must demonstrate benefit over traditional methods without adversely affecting outcomes. Further, integrating remote biochemical verification of smoking and abstinence may yield value in the confirmation of self-reported smoking, in addition to ecologically valid, real-time assessments. Objective: The goal of this study was to evaluate the impact of remote biochemical verification on 24-hour self-reported smoking and biochemical verification agreement, retention, compliance with remote sessions, and abstinence during a brief, 5-week cessation attempt and relapse monitoring phase. Methods: Participants (N=39; aged 18-25 years; mean age 21.6, SD 2.1 years; n=22, 56% male; n=29, 74% White) who smoked cigarettes daily engaged in a 5-week cessation and monitoring study (including a 48-hour quit attempt and provision of tobacco treatment in the form of nicotine replacement therapy, brief cessation counseling, and financial incentives for abstinence during the 2-day quit attempt only). Smoking (cigarettes per day) was self-reported through ecological momentary assessment (EMA) procedures, and participants were randomized to either (1) the inclusion of remote biochemical verification (EMA + remote carbon monoxide [rCO]) 2× per day or (2) in-person, weekly CO (wCO). Groups were compared on the following outcomes: (1) agreement in self-reported smoking and breath carbon monoxide (CO) at common study time points, (2) EMA session compliance, (3) retention in study procedures, and (4) abstinence from smoking during the 2-day quit attempt and at the end of the 5-week study. Results: No significant differences were demonstrated between the rCO group and the wCO (weekly in-person study visit) group on agreement between 24-hour self-reported smoking and breath CO (moderate to poor), compliance with remote sessions, or retention, though these outcomes numerically favored the wCO group. Abstinence was numerically higher in the wCO group after the 2-day quit attempt and significantly different at the end of treatment (day 35), favoring the wCO group. Conclusions: Though study results should be interpreted with caution given the small sample size, findings suggest that the inclusion of rCO breath added to EMA compared to EMA with weekly, in-person CO collection in young adults did not yield benefit and may have even adversely affected outcomes. Our results suggest that technological advancements may improve data accuracy through objective measurement but may also introduce barriers and burdens and could result in higher rates of missing data. The inclusion of technology to inform smoking cessation research and intervention delivery among young adults should consider (1) the research question and necessity of biochemical verification and then (2) how to seamlessly incorporate monitoring into personalized and dynamic systems to avoid the added burden and detrimental effects to compliance and honesty in self-report. %M 37498643 %R 10.2196/47662 %U https://formative.jmir.org/2023/1/e47662 %U https://doi.org/10.2196/47662 %U http://www.ncbi.nlm.nih.gov/pubmed/37498643 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47665 %T Increasing Physical Activity in Persons With Spinal Cord Injury With an eHealth-Based Adaptive Exercise Intervention: Protocol for a Sequential Multiple Assignment Randomized Trial %A Wilroy,Jereme %A Kim,Yumi %A Lai,Byron %A Young,Hui-Ju %A Giannone,John %A Powell,Danielle %A Thirumalai,Mohanraj %A Mehta,Tapan %A Rimmer,James %+ Department of Physical Medicine and Rehabilitation, University of Alabama at Birmingham, 1717 6th Ave S, Birmingham, AL, 35233, United States, 1 205 934 4508, jdwilroy@uab.edu %K exercise %K physical activity %K spinal cord injury %K adaptive intervention %D 2023 %7 27.7.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Participating in an adequate amount of physical activity to acquire health benefits is challenging for people with spinal cord injury (SCI) due to personal and logistic barriers. Barriers in the built and social environments may include lack of transportation, lack of accessible facilities or programs, and lack of training among fitness personnel. Low self-efficacy, lack of self-regulation skills, and improper outcome expectations are examples of personal barriers. Current approaches to investigating physical activity programs in people with SCI have been limited to traditional “one-size-fits-all” design, which has yielded low adherence rates, high dropout rates, and participants not maintaining physical activity levels at follow-up. Objective: The primary aim of this study is to test the feasibility of a tele-exercise program that applies an adaptive intervention design for 30 adults with SCI, targeting increases in adherence to the exercise program and physical activity participation. Methods: The Sequential Multiple Assignment Randomized Trial for Home-based Exercise and Lifestyle Tele-Health (SMART-HEALTH) is a 12-week, home-based, movement-to-music (M2M) program. The goal of a SMART-designed study is to develop an adaptive intervention that modifies support provisions based on response levels. In SMART-HEALTH, 2 groups of participants will undergo 3-week and 6-week asynchronous M2M interventions in the first phase. Participants who did not achieve the desired adherence rate (≥95% of video watch minutes) will be rerandomized into M2M Live (switch) or individualized behavioral coaching (augmented with the asynchronous M2M program). The study will primarily assess rates of recruitment or enrollment, adherence and retention, timing to identify nonresponders, and scientific outcomes (eg, physical activity and exercise self-efficacy). The study will qualitatively evaluate the acceptability of the study using semistructured interviews among participants who complete the 12-week intervention. Results: Recruitment procedures started in June 2022. All data are expected to be collected by September 2023. Full trial results are expected to be published by March 2024. Secondary analyses of data will be subsequently published. Results will include exercise adherence rates; changes in self-reported physical activity levels and blood pressure; and changes in secondary conditions including pain, sleep, and fatigue. Thematic analysis of semistructured interviews will include results on participant enjoyment and acceptability of SMART-HEALTH and inform modifications for future delivery of the program. Conclusions: This study will strengthen our understanding of the potential benefits of the tele-exercise intervention for people with SCI and build upon adaptive intervention design and its delivery strategies that aim to increase adoption and sustainable exercise behavior. This pilot trial will inform future SMART-designed studies and provide new and innovative strategies for investigating intervention effects on physical activity behavior in the SCI population. Trial Registration: ClinicalTrials.gov NCT04726891; https://classic.clinicaltrials.gov/ct2/show/NCT04726891 International Registered Report Identifier (IRRID): DERR1-10.2196/47665 %M 37498650 %R 10.2196/47665 %U https://www.researchprotocols.org/2023/1/e47665 %U https://doi.org/10.2196/47665 %U http://www.ncbi.nlm.nih.gov/pubmed/37498650 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46092 %T Tele-Instruction Tool for Multiple Lay Responders Providing Cardiopulmonary Resuscitation in Telehealth Emergency Dispatch Services: Mixed Methods Study %A Xu,Jianing %A Qu,Mingyu %A Dong,Xuejie %A Chen,Yihe %A Yin,Hongfan %A Qu,Fangge %A Zhang,Lin %+ School of Public Health, Shanghai Jiao Tong University, 227 Chongqing Road, Shanghai, 200025, China, 86 63846590, zhanglynn@sjtu.edu.cn %K cardiac arrest %K lay responder %K teamwork %K telehealth %K telephone-assisted cardiopulmonary resuscitation %D 2023 %7 26.7.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Telephone-assisted cardiopulmonary resuscitation (T-CPR) has proven to be a crucial intervention in enhancing the ability of lay responders to perform cardiopulmonary resuscitation (CPR) during telehealth emergency services. While the majority of established T-CPR protocols primarily focus on guiding individual rescuers, there is a lack of emphasis on instructing and coordinating multiple lay responders to perform resuscitation collaboratively. Objective: This study aimed to develop an innovative team-based tele-instruction tool to efficiently organize and instruct multiple lay responders on the CPR process and to evaluate the effectiveness and feasibility of the tool. Methods: We used a mixed methods design in this study. We conducted a randomized controlled simulation trial to conduct the quantitative analysis. The intervention groups used the team-based tele-instruction tool for team resuscitation, while the control groups did not have access to the tool. Baseline resuscitation was performed during the initial phase (phase I test). Subsequently, all teams watched a team-based CPR education training video and finished a 3-person practice session with teaching followed by a posttraining test (phase II test). In the qualitative analysis, we randomly selected an individual from each team and 4 experts in emergency medical services to conduct semistructured interviews. The purpose of these interviews was to evaluate the effectiveness and feasibility of this tool. Results: The team-based tele-instruction tool significantly improved the quality of chest compression in both phase I and phase II tests. The average compression rates were more appropriate in the intervention groups compared to the control groups (median 104.5, IQR 98.8-111.8 min–1 vs median 112, IQR 106-120.8 min–1; P=.04 in phase I and median 117.5, IQR 112.3-125 min–1 vs median 111, IQR 105.3-119 min–1; P=.03 in phase II). In the intervention group, there was a delay in the emergency response time compared to that in the control group (time to first chest compression: median 20, IQR 15-24.8 seconds vs median 25, IQR 20.5-40.3 seconds; P=.03; time to open the airway: median 48, IQR 36.3-62 seconds vs median 73.5, IQR 54.5-227.8 seconds; P=.01). However, this delay was partially mitigated after the phase II test. The qualitative results confirmed the compatibility and generalizability of the team-based tele-instruction tool, demonstrating its ability to effectively guide multiple lay responders through teamwork and effective communication with telecommunicators. Conclusions: The use of the team-based tele-instruction tool offers an effective solution to enhance the quality of chest compression among multiple lay responders. This tool facilitated the organization of resuscitation teams by dispatchers and enabled efficient cooperation. Further assessment of the widespread adoption and practical application of the team-based tele-instruction tools in real-life rescue scenarios within the telehealth emergency services system is warranted. %M 37494107 %R 10.2196/46092 %U https://www.jmir.org/2023/1/e46092 %U https://doi.org/10.2196/46092 %U http://www.ncbi.nlm.nih.gov/pubmed/37494107 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45027 %T Boosting Empathy and Compassion Through Mindfulness-Based and Socioemotional Dyadic Practice: Randomized Controlled Trial With App-Delivered Trainings %A Silveira,Sarita %A Godara,Malvika %A Singer,Tania %+ Social Neuroscience Lab, Max Planck Society, Bertha-Benz-Str 3, Berlin, 10557, Germany, 49 030 23608 1512, sarita.silveira@social.mpg.de %K mental training %K compassion %K empathy %K mindfulness %K dyadic practice %K acceptance %K digital mental health %K self-compassion %K app-delivered training %K Affect Dyad %K mobile phone %D 2023 %7 26.7.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Contemplative trainings have been found to effectively improve social skills such as empathy and compassion. However, there is a lack of research on the efficacy of app-delivered mindfulness-based and dyadic practices in boosting socioaffective capacity. Objective: The first aim of this study was to compare a novel app-delivered, partner-based socioemotional intervention (Affect Dyad) with mindfulness-based training to foster empathy and compassion for the self or others. The second aim of this study was to investigate the underlying mechanisms of these effects. Methods: This randomized controlled trial included socioemotional and mindfulness-based interventions and a waitlist control group, which received socioemotional training after the postintervention assessment. We used linear mixed-effects models to test intervention effects on self-report measures and an ecologically valid computer task of empathy, compassion for the self and others, and theory of mind. Moderated mediation models were used to investigate whether changes in acceptance, empathic distress, empathic listening, interoceptive awareness, and mindfulness served as underlying psychological processes of intervention effects. Results: In 218 participants (mean age 44.12, SD 11.71 years; 160/218, 73.4% female), we found all interventions to have positive effects on composite scores for compassion toward the self (βsocioemotional=.44, P<.001; βwaitlist socioemotional=.30, P=.002; βmindfulness-based=.35, P<.001) and others (βsocioemotional=.24, P=.003; βwaitlist socioemotional=.35, P<.001; βmindfulness-based=.29, P<.001). Compassion measured with the computer task did not change significantly but showed a trend toward increase only in socioemotional dyadic practice (βsocioemotional=.08, P=.08; βwaitlist socioemotional=.11, P=.06). Similarly, on the empathic concern subscale of the Interpersonal Reactivity Index, a nonsignificant trend toward increase was found in the socioemotional intervention group (βsocioemotional=.17; P=.08). Empathy significantly increased in both socioemotional groups (βsocioemotional=.16, P=.03; βwaitlist socioemotional=.35, P<.001) and the mindfulness-based group (βmindfulness-based=.15; P=.04). The measures of theory of mind did not change over time. In the mindfulness-based group, the increase in self-compassion was mediated by a decrease in empathic distress (indirect effect abmindfulness-based=0.07, 95% CI 0.02-0.14). In the socioemotional group, an increase in self-compassion could be predicted by an increase in acceptance (βsocioemotional=6.63, 95% CI 0.52-12.38). Conclusions: Using a multimethod approach, this study shows that app-delivered socioemotional and mindfulness-based trainings are effective in fostering compassion for the self and others in self-report. Both low-dose trainings could boost behavioral empathy markers; however, the effects on behavioral and dispositional markers of compassion only trended after dyadic practice, yet these effects did not reach statistical significance. Training-related increases in self-compassion rely on differential psychological processes, that is, on improved empathic distress regulation through mindfulness-based training and the activation of a human care– and acceptance-based system through socioemotional dyadic training. Trial Registration: ClinicalTrials.gov NCT04889508; https://clinicaltrials.gov/ct2/show/NCT04889508 %M 37494106 %R 10.2196/45027 %U https://www.jmir.org/2023/1/e45027 %U https://doi.org/10.2196/45027 %U http://www.ncbi.nlm.nih.gov/pubmed/37494106 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43219 %T Digital Parenting Interventions for Fathers of Infants From Conception to the Age of 12 Months: Systematic Review of Mixed Methods Studies %A Xie,Elisabeth Bailin %A Jung,James Wonkyu %A Kaur,Jasleen %A Benzies,Karen M %A Tomfohr-Madsen,Lianne %A Keys,Elizabeth %+ School of Nursing, The University of British Columbia, Okanagan Campus, 1147 Research Road, Kelowna, BC, V1V 1V7, Canada, 1 (250) 807 8344, elizabeth.keys@ubc.ca %K eHealth %K digital intervention %K father %K perinatal %K infant %K parenting %K mobile phone %K review %D 2023 %7 26.7.2023 %9 Review %J J Med Internet Res %G English %X Background: Digital interventions help address barriers to traditional health care services. Fathers play an important parenting role in their families, and their involvement is beneficial for family well-being. Although digital interventions are a promising avenue to facilitate father involvement during the perinatal period, most are oriented toward maternal needs and do not address the unique needs of fathers. Objective: This systematic review describes the digital interventions that exist or are currently being developed for fathers of infants from conception to 12 months postpartum. Methods: A systematic search of the MEDLINE, PsycINFO, Cochrane Central Register of Controlled Trials, Embase (using Ovid), and CINAHL (using EBSCO) databases was conducted to identify articles from database inception to June 2022, of which 39 met the inclusion criteria. Articles were included if they were peer-reviewed and described a digital intervention that targeted fathers of fetuses or infants aged ≤12 months. Systematic reviews, meta-analyses, and opinion pieces were excluded. Data from these studies were extracted and themed using a narrative synthesis approach. Quality appraisal of the articles was conducted using the Mixed Methods Appraisal Tool. Results: A total of 2816 articles were retrieved, of which 39 (1.38%) met the inclusion criteria for eligibility after removing duplicates and screening. Eligible articles included 29 different interventions across 13 countries. Most articles (22/29, 76%) described interventions that were exclusively digital. There were a variety of digital modalities, but interventions were most commonly designed to be delivered via a website or web-based portal (14/29, 48%). Just over half (21/39, 54%) of the articles described interventions designed to be delivered from pregnancy through the postpartum period. Only 26% (10/39) of the studies targeted fathers exclusively. A wide range of outcomes were included, with 54% (21/39) of the studies including a primary outcome related to intervention feasibility. Qualitative and mixed methods studies reported generally positive experiences with digital interventions and qualitative themes of the importance of providing support to partners, improving parenting confidence, and normalization of stress were identified. Of the 18 studies primarily examining efficacy outcomes, 13 (72%) reported a statistically significant intervention effect. The studies exhibited a moderate quality level overall. Conclusions: New and expecting fathers use digital technologies, which could be used to help address father-specific barriers to traditional health care services. However, in contrast to the current state of digital interventions for mothers, father-focused interventions lack evaluation and evidence. Among the existing studies on digital interventions for fathers, there seem to be mixed findings regarding their feasibility, acceptability, and efficacy. There is a need for more development and standardized evaluation of interventions that target father-identified priorities. This review was limited by not assessing equity-oriented outcomes (eg, race and socioeconomic status), which should also be considered in future intervention development. %M 37494086 %R 10.2196/43219 %U https://www.jmir.org/2023/1/e43219 %U https://doi.org/10.2196/43219 %U http://www.ncbi.nlm.nih.gov/pubmed/37494086 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42852 %T Mobile Apps and Quality of Life in Patients With Breast Cancer and Survivors: Systematic Literature Review %A Saevarsdottir,Saeunn Rut %A Gudmundsdottir,Sigridur Lara %+ University of Iceland, Department of Health Promotion, Sport & Leisure Studies, Stakkahlid 1, Reykjavik, 105, Iceland, 354 5255950, srs33@hi.is %K mobile health %K mHealth %K breast cancer %K quality of life %K review %K systematic review %K cancer treatment %K mobile app %K patient care %K survivorship %K digital health intervention %K lifestyle intervention %K mobile phone %D 2023 %7 26.7.2023 %9 Review %J J Med Internet Res %G English %X Background: Side effects of breast cancer treatment may persist long into survivorship, reducing quality of life (QOL) in patients with breast cancer and survivors. There is growing evidence for the use of digital health technologies, such as mobile apps, to support self-management, decrease symptom burden, and improve QOL in patients with cancer. However, an updated overview of the effects of mobile apps on QOL and well-being in patients with breast cancer and survivors is needed. Objective: The aim of this review was to provide an overview of breast cancer–specific, mobile app–driven lifestyle or behavioral interventions in patient care through to survivorship and their impact on QOL and mental well-being. Methods: A systematic search of PubMed, Scopus, and Web of Science was conducted to identify relevant studies. The inclusion criteria were limited to original studies involving a trial of a mobile app–driven lifestyle or behavioral intervention for patients with breast cancer or survivors and using QOL or well-being measures. The results of the studies that met the inclusion criterion were then synthesized in text and table format. The quality of the evidence was assessed with the Cochrane risk-of-bias tool. Results: A total of 17 studies with the number of participants ranging from 23 to 356 met the inclusion criterion. Of the 17 reviewed studies, 7 (41%) delivered an app-only intervention, and 10 (59%) combined an app with additional supporting materials, such as SMS text messaging, telecoaching, wearables, or printed materials. Among the 17 reviewed studies, 6 (35%) focused on aiding patients with breast cancer during the active treatment phase (excluding ongoing hormone therapy), whereas the remaining 11 (65%) focused on survivorship. The majority of the studies (14/17, 82%) observed some positive effects on QOL or well-being measures. Conclusions: The results of the review indicate that mobile apps are a promising avenue for improving QOL and well-being in breast cancer care. Positive effects were observed in patients undergoing active treatment in all reviewed studies, but effects were less clear after chemotherapy and in long-term survivors. Although lifestyle and behavioral digital interventions are still being developed, and further research should still be pursued, the available data suggest that current mobile health apps aid patients with breast cancer and survivors. %M 37494111 %R 10.2196/42852 %U https://www.jmir.org/2023/1/e42852 %U https://doi.org/10.2196/42852 %U http://www.ncbi.nlm.nih.gov/pubmed/37494111 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 9 %N %P e44745 %T Effectiveness of Multicomponent Interventions in Office-Based Workers to Mitigate Occupational Sedentary Behavior: Systematic Review and Meta-Analysis %A Zhou,Liying %A Deng,Xinxin %A Guo,Kangle %A Hou,Liangying %A Hui,Xu %A Wu,Yanan %A Xu,Meng %A Wang,Yongsheng %A Liang,Shanshan %A Yang,Kehu %A Li,Xiuxia %+ Health Technology Assessment Center/Evidence-Based Social Science Research Center, School of Public Health, Lanzhou University, 199 Donggang West Road, Lanzhou, 730000, China, 86 13893624871, lixiuxia@lzu.edu.cn %K sedentary behavior %K workplace %K multicomponent %K systematic review %D 2023 %7 26.7.2023 %9 Review %J JMIR Public Health Surveill %G English %X Background: Sedentary time in workplaces has been linked to increased risks of chronic occupational diseases, obesity, and overall mortality. Currently, there is a burgeoning research interest in the implementation of multicomponent interventions aimed at decreasing sedentary time among office workers, which encompass a comprehensive amalgamation of individual, organizational, and environmental strategies. Objective: This meta-analysis aims at evaluating the effectiveness of multicomponent interventions to mitigate occupational sedentary behavior at work compared with no intervention. Methods: PubMed, Web of Science, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched from database inception until March 2023 to obtain randomized controlled trials (RCTs) assessing the efficacy of multicomponent interventions on occupational sedentary behavior among office-based workers. Two reviewers independently extracted the data and assessed the risk of bias by using the Cochrane Collaboration’s risk of bias tool. The average intervention effect on sedentary time was calculated using Stata 15.1. Mean differences (MDs) with 95% CIs were used to calculate the continuous variables. Subgroup analyses were performed to determine whether sit-stand workstation, feedback, and prompt elements played an important role in multicomponent interventions. Further, the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system was used to evaluate the certainty of evidence. Results: A total of 11 RCTs involving 1894 patients were included in the analysis. Five studies were rated as low risk of bias, 2 as unclear risk of bias, and 4 as high risk. The meta-analysis results showed that compared with no intervention, multicomponent interventions significantly reduced occupational sitting time (MD=–52.25 min/8-h workday, 95% CI –73.06 to –31.44; P<.001) and occupational prolonged sitting time (MD=–32.63 min/8-h workday, 95% CI –51.93 to –13.33; P=.001) and increased occupational standing time (MD=44.30 min/8-h workday, 95% CI 23.11-65.48; P<.001), whereas no significant differences were found in occupational stepping time (P=.06). The results of subgroup analysis showed that compared with multicomponent interventions without installment of sit-stand workstations, multicomponent interventions with sit-stand workstation installment showed better effects for reducing occupational sitting time (MD=–71.95 min/8-h workday, 95% CI –92.94 to –51.15), increasing occupational standing time (MD=66.56 min/8-h workday, 95% CI 43.45-89.67), and reducing occupational prolonged sitting time (MD=–47.05 min/8-h workday, 95% CI –73.66 to –20.43). The GRADE evidence summary showed that all 4 outcomes were rated as moderate certainty. Conclusions: Multicomponent interventions, particularly those incorporating sit-stand workstations for all participants, are effective at reducing workplace sedentary time. However, given their cost, further research is needed to understand the effectiveness of low-cost/no-cost multicomponent interventions. %M 37494100 %R 10.2196/44745 %U https://publichealth.jmir.org/2023/1/e44745 %U https://doi.org/10.2196/44745 %U http://www.ncbi.nlm.nih.gov/pubmed/37494100 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e42768 %T User-Centered Design of a Digitally Enabled Care Pathway in a Large Health System: Qualitative Interview Study %A McCue,Maggie %A Khatib,Rasha %A Kabir,Christopher %A Blair,Chris %A Fehnert,Ben %A King,James %A Spalding,Alexander %A Zaki,Lara %A Chrones,Lambros %A Roy,Anit %A Kemp,David E %+ Takeda Pharmaceuticals U.S.A., Inc., 95 Hayden Ave, Lexington, MA, 02421, United States, 1 708 519 0271, Chris.Blair@takeda.com %K depression %K major depressive disorder %K depression management %K patient engagement %K user-centered design %K mobile app %K digital platform %K qualitative research %K shared decision-making %K measurement-based care %K mobile phone %D 2023 %7 26.7.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Major depressive disorder (MDD) is a leading cause of disability worldwide. Management of chronic conditions such as MDD can be improved by enhanced patient engagement, measurement-based care (MBC), and shared decision-making (SDM). A user-centered design approach can improve the understanding of the patient journey and care team workflows and thus aid the development of digital health care innovations optimized for the needs of patients living with MDD and their primary care teams. Objective: This study aims to use qualitative research methods for the user-centered design of a digitally enabled MDD care platform, PathwayPlatform, intended to enhance patient engagement, MBC, and SDM. Methods: Insights were gathered through 2 stages of qualitative interviews by a study team with expertise in qualitative research and user-centered design methods. Thematic analysis was used to generate an overarching understanding of a set of shared experiences, thoughts, or behaviors across a broad qualitative data set, including transcripts of interviews, to allow both inductive and deductive insights to emerge. Thematic analysis of interviews was supported by Dedoose (SocioCultural Research Consultants, LLC), a qualitative data analysis software tool that enables systematized coding. Findings and insights were presented based on code frequency, salience, and relevance to the research project. Results: In stage 1, interviews were conducted with 20 patients living with MDD and 15 health care providers from September 2018 to January 2019 to understand the experiences with and perceptions about the initial functionality of the Pathway app while also exploring the perceptions about potential additional features and functionality. Feedback about care team workflows and treatment approaches was collected in stage-2 interviews with 36 health care providers at 8 primary care sites. Inductive and deductive thematic analyses revealed several themes related to app functionality, patient-provider engagement, workflow integration, and patient education. Both patients and their care teams perceived the remote tracking of patient-reported outcomes via digital tools to be clinically useful and reliable and to promote MBC and SDM. However, there was emphasis on the need to enhance the flow of real-time data shared with the care team, improve trend visualizations, and integrate the data within the existing clinical workflow and educational programs for patients and their care teams. User feedback was incorporated into the iterative development of the Pathway app. Conclusions: Ongoing communication with patients living with MDD and their care teams provided an opportunity for user-centric developmental iterations of the Pathway Platform. Key insights led to further development of the patient-facing and care team–facing visit preparation features, collaborative goal-setting and goal-tracking features, patient-reported outcome summaries, and trend visualizations. The result is an enhanced digital platform with the potential to improve treatment outcomes and provide patients living with MDD additional support throughout their treatment journey. %M 37494099 %R 10.2196/42768 %U https://humanfactors.jmir.org/2023/1/e42768 %U https://doi.org/10.2196/42768 %U http://www.ncbi.nlm.nih.gov/pubmed/37494099 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45098 %T Factors Influencing Nutritional Intake and Interests in Educational Content of Athletes and Sport Professionals Toward the Development of a Clinician-Supported Mobile App to Combat Relative Energy Deficiency in Sport: Formative Research and a Description of App Functions %A Mey,Jacob T %A Karpinski,Christine A %A Yang,Shengping %A Madere,Joseph D %A Piattoly,Tavis %A Harper,Ronnie %A Kirwan,John P %+ Pennington Biomedical Research Center, 6400 Perkins Road, Baton Rouge, LA, 70808, United States, 1 2257632644, jacob.mey@pbrc.edu %K dietitian %K malnutrition %K mHealth %K mobile health %K performance %K RED-S %K relative energy deficiency in sport %K sports nutrition %K technology %D 2023 %7 26.7.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Relative energy deficiency in sport (RED-S) as a consequence of athlete malnutrition remains a prominent issue. However, it remains underrecognized, in part due to the perceived outward health of athletes. The Eat2Win app was designed to combat RED-S and athlete malnutrition by providing education, behavior modification, and direct communication with expert sports dietitians to athletes and sport professionals (professionals who work with athletes, eg, sport coaches and athletic trainers). Objective: The purpose of this formative research was to gain critical insight on motivators and barriers to optimal nutritional intake from both the athletes’ and sport professionals’ perspectives. Additionally, since these 2 groups represent the primary end users of an app aimed at improving athlete nutrition and reducing the risk of RED-S, a secondary objective was to gain insight on the preferences and perceptions of app-based educational content and functionality. Methods: An electronic survey was developed by an interdisciplinary team of experts. Survey questions were established based upon prevailing literature, professional dietetic field experience, and app design considerations to obtain respondent knowledge on key sports nutrition topics along with motivations and barriers to meal choices. Additionally, the survey included questions about the development of an integrative, clinician-support app aimed at addressing RED-S. These questions included preferences for educational content, modes of in-app information, and communication delivery for the target population (app end users: athletes and sport professionals). The survey was distributed through Research Electronic Data Capture (REDCap) to athletes and sport professionals using targeted email, social media, and community engagement campaigns. The electronic survey was available from May 4 to August 2, 2022. Results: Survey respondents (n=1352) included athletes and professionals who work with athletes from a variety of settings, like high school, collegiate, professional, and club sports. Respondents reported high interest in 8 core sports nutrition topics. The preferred modes of information and communication delivery were visual formats (eg, videos and infographics) and in-app alerts (eg, direct messaging and meal reminders). Only athlete respondents were asked about motivators and barriers that influence meal choices. “Health” and “sports performance” were the highest scoring motivators, while the highest scoring barriers were “cost of food,” “easy access to unhealthy food,” and “time to cook or prepare food.” Notably, survey respondents provided positive feedback and interest using a novel function of the app: real-time meal feedback through food photography. Conclusions: The Eat2Win app is designed to combat RED-S and athlete malnutrition. Results from this study provide critical information on end-user opinions and preferences and will be used to further develop the Eat2Win app. Future research will aim to determine whether the Eat2Win app can prevent RED-S and the risk of athlete malnutrition to improve both health and performance. %M 37494083 %R 10.2196/45098 %U https://formative.jmir.org/2023/1/e45098 %U https://doi.org/10.2196/45098 %U http://www.ncbi.nlm.nih.gov/pubmed/37494083 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46935 %T Advance Care Planning Website for People With Dementia and Their Family Caregivers: Protocol for a Development and Usability Study %A Monnet,Fanny %A Dupont,Charlèss %A Smets,Tinne %A De Vleminck,Aline %A Van Audenhove,Chantal %A Van den Block,Lieve %A Pivodic,Lara %+ End-of-Life Care Research Group, Vrije Universiteit Brussel and Ghent University, Laarbeeklaan 103, Brussels, 1090, Belgium, 32 499260389, fanny.monnet@vub.be %K advance care planning %K people with dementia %K technology %K development %K usability testing %K dementia %K caregiver %K web-based tools %K digital health %K user-centered approach %D 2023 %7 26.7.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Web-based tools for people with dementia and their family caregivers have considerably increased over the years and offer promising solutions to several unmet needs such as supporting self-care in daily life, facilitating treatment delivery, or ensuring their ability to communicate. The use of web-based tools in the field of advance care planning (ACP) for people with dementia and their family caregivers has yet to be explored and requires careful consideration, given the sensitive topic and the specific needs of people with dementia and their families. Objective: This paper reports the protocol for a study aiming to develop and simultaneously test the usability of an ACP website designed for, and with, people with dementia and their families. Methods: The development of the website is based on a process map for the development of web-based decision support interventions and on the Medical Research Council framework for complex intervention development and evaluation. Additionally, we apply a user-centered approach in combination with patient and public involvement (PPI) throughout the development process. We describe our iterative development approach to the website. Participants and a PPI group give feedback on 4 prototypes of the ACP website. For each iteration, we aim to include 12 participants (3 people with dementia, 3 family caregivers, and 3 dyads) in usability testing. In the first 3 iterations, usability testing includes (1) a think-aloud exercise, (2) researcher observations, and (3) the System Usability Scale questionnaire. The last iteration of usability testing is composed of a semistructured interview assessing the layout, content, face validity, and readability of the website. Qualitative data from the think-aloud exercises and interviews are analyzed using thematic analysis. Mean scores are calculated for the System Usability Scale questionnaire. Results: This study received approval from the Ethical Review Board of Brussels University Hospital of the Vrije Universiteit Brussel. Recruitment began in October 2021. The target date for paper submission of the results of the development and usability testing will be in 2023. Conclusions: The methods in this protocol describe a feasible and inclusive approach to the development of an ACP website together with people with dementia, their family caregivers, and other stakeholders. We provide a clear overview of how to combine PPI input and user-centered development methods, leading to a transparent and reliable development process. This protocol might stimulate the active participation of people with dementia, their caregivers, and regional stakeholders in future studies on web-based technologies. The results of this study will be used to refine the design and create a relevant and user-friendly ACP website that is ready to be tested in a larger evaluation study. International Registered Report Identifier (IRRID): DERR1-10.2196/46935 %M 37494084 %R 10.2196/46935 %U https://www.researchprotocols.org/2023/1/e46935 %U https://doi.org/10.2196/46935 %U http://www.ncbi.nlm.nih.gov/pubmed/37494084 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41440 %T Evaluation of a Web-Based Self-Help Intervention for Patients With Generalized Anxiety Disorder: Protocol for a Randomized Controlled Trial %A Rubel,Julian %A Quest,Jannis %A Pruessner,Luise %A Timm,Christina %A Hartmann,Steffen %A Barnow,Sven %A Rittmeyer,Lisa %A Rosenbaum,David %A Lalk,Christopher %+ Faculty of Psychology and Sport Science, Justus-Liebig-University Giessen, Otto-Behaghel-Straße 10, Haus F1, Gießen, 35394, Germany, 49 1758438839, Christopher.lalk@uni-osnabrueck.de %K generalized anxiety disorder %K GAD %K online self-help %K randomized controlled trial %K RCT %K self-help %K guided %K anxiety %K online intervention %K mental health %K mental illness %K mental disorder %K psychotherapy %K internet-based %K internet intervention %K web-based %D 2023 %7 26.7.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Generalized anxiety disorder (GAD) is a highly prevalent and severely distressing condition that can lead to functional impairments and is considered one of the most difficult anxiety disorders to treat. Following new technological developments, a highly structured cognitive behavioral therapy (CBT) approach that has already shown success in face-to-face psychotherapy can be implemented: internet-delivered CBT (iCBT). There is now evidence for the efficacy of both guided and unguided iCBT interventions for GAD regarding symptom reduction. Objective: To establish the usefulness of such interventions, we plan to evaluate the efficacy of a web-based self-help program (Selfapy) for GAD in a relatively large sample. We aim to assess effects beyond symptom reduction, including effects on well-being, functioning, and mental health literacy, as well as the effect on health care burden, while testing the intervention in conditions comparable to routine care. Methods: Patients (n=156) who have been diagnosed with GAD, are aged between 18 and 65 years, have internet access, and have sufficient German language skills will be recruited for this study. The intervention group (n=78) will receive access to the 12-week self-help web-based program Selfapy. The waitlist control group (n=78) will receive no intervention in the context of the study. However, both groups will be allowed to access further health care services (eg, psychotherapy, medication), reflecting current routine care in Germany. Outcome measures will be assessed at baseline (T1) and 6 weeks (T2) and 12 weeks (T3) after the start of the intervention. The primary outcome will be generalized anxiety symptoms and quality of life at T3. Additional outcomes include depression, work capacity, therapy-related expenses and burdens, health literacy, and negative effects. Results: By May 2023, all participants had finished the trial and the report was being prepared for publication. Conclusions: Web-based interventions may be an important addition to the German health care system to reduce barriers to treatment access. Further, they may prove cost-effective for the treatment of GAD. Trial Registration: Deutsches Register Klinischer Studien DRKS00023799; https://tinyurl.com/22bds38x International Registered Report Identifier (IRRID): DERR1-10.2196/41440 %M 37494105 %R 10.2196/41440 %U https://www.researchprotocols.org/2023/1/e41440 %U https://doi.org/10.2196/41440 %U http://www.ncbi.nlm.nih.gov/pubmed/37494105 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45658 %T Digital Endpoints for Assessing Instrumental Activities of Daily Living in Mild Cognitive Impairment: Systematic Review %A Lawson,Lauren %A Mc Ardle,Ríona %A Wilson,Sarah %A Beswick,Emily %A Karimi,Radin %A Slight,Sarah P %+ School of Pharmacy, Population Health Sciences Institute, Newcastle University, King George VI Building, Newcastle Upon Tyne, NE1 7RU, United Kingdom, 44 7739174547, sarah.slight@newcastle.ac.uk %K mild cognitive impairment %K MCI %K functional status %K activities of daily living %K instrumental activities of daily living %K IADLs %K digital technology %K mobile phone %D 2023 %7 25.7.2023 %9 Review %J J Med Internet Res %G English %X Background: Subtle impairments in instrumental activities of daily living (IADLs) can be a key predictor of disease progression and are considered central to functional independence. Mild cognitive impairment (MCI) is a syndrome associated with significant changes in cognitive function and mild impairment in complex functional abilities. The early detection of functional decline through the identification of IADL impairments can aid early intervention strategies. Digital health technology is an objective method of capturing IADL-related behaviors. However, it is unclear how these IADL-related behaviors have been digitally assessed in the literature and what differences can be observed between MCI and normal aging. Objective: This review aimed to identify the digital methods and metrics used to assess IADL-related behaviors in people with MCI and report any statistically significant differences in digital endpoints between MCI and normal aging and how these digital endpoints change over time. Methods: A total of 16,099 articles were identified from 8 databases (CINAHL, Embase, MEDLINE, ProQuest, PsycINFO, PubMed, Web of Science, and Scopus), out of which 15 were included in this review. The included studies must have used continuous remote digital measures to assess IADL-related behaviors in adults characterized as having MCI by clinical diagnosis or assessment. This review was conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Results: Ambient technology was the most commonly used digital method to assess IADL-related behaviors in the included studies (14/15, 93%), with passive infrared motion sensors (5/15, 33%) and contact sensors (5/15, 33%) being the most prevalent types of methods. Digital technologies were used to assess IADL-related behaviors across 5 domains: activities outside of the home, everyday technology use, household and personal management, medication management, and orientation. Other recognized domains—culturally specific tasks and socialization and communication—were not assessed. Of the 79 metrics recorded among 11 types of technologies, 65 (82%) were used only once. There were inconsistent findings around differences in digital IADL endpoints across the cognitive spectrum, with limited longitudinal assessment of how they changed over time. Conclusions: Despite the broad range of metrics and methods used to digitally assess IADL-related behaviors in people with MCI, several IADLs relevant to functional decline were not studied. Measuring multiple IADL-related digital endpoints could offer more value than the measurement of discrete IADL outcomes alone to observe functional decline. Key recommendations include the development of suitable core metrics relevant to IADL-related behaviors that are based on clinically meaningful outcomes to aid the standardization and further validation of digital technologies against existing IADL measures. Increased longitudinal monitoring is necessary to capture changes in digital IADL endpoints over time in people with MCI. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42022326861; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=326861 %M 37490331 %R 10.2196/45658 %U https://www.jmir.org/2023/1/e45658 %U https://doi.org/10.2196/45658 %U http://www.ncbi.nlm.nih.gov/pubmed/37490331 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45164 %T A National Health and Wellness SMS Text Message Program for Breast Cancer Survivors During COVID-19 (EMPOWER-SMS COVID-19): Mixed Methods Evaluation Using the RE-AIM Framework %A Singleton,Anna C %A Raeside,Rebecca %A Hyun,Karice K %A Hayes,Molly %A Sherman,Kerry A %A Elder,Elisabeth %A Redfern,Julie %A Partridge,Stephanie R %+ Engagement and Co-Design Research Hub, School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Level 6 Block K Westmead Hospital, Sydney, 2753, Australia, 61 2 9351 2222, anna.singleton@sydney.edu.au %K digital health %K telemedicine %K SMS text messaging %K breast cancer %K implementation science %K cancer survivorship %K supportive care %K public health %K COVID-19 %D 2023 %7 25.7.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: COVID-19 lockdowns caused widespread closures of supportive care services for breast cancer survivors in Australia. In a randomized controlled trial, our team’s lifestyle-focused, evidence-based SMS text message support program (EMPOWER-SMS COVID-19) was found to be acceptable and useful for breast cancer survivors, and it was ready for rapid widespread delivery. Objective: This study aims to evaluate the reach (uptake) of an adapted 3-month lifestyle-focused SMS text message program (EMPOWER-SMS COVID-19) and barriers and enablers to implementation using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Methods: A mixed methods pre-post study was conducted to evaluate the EMPOWER-SMS COVID-19 program. The study evaluated the following aspects: (1) reach/representativeness, which refers to the proportion of participant enrollment (ie, number enrolled/number that visited the study website) and demographics (eg, age, sex, ethnicity, time since completing treatment, Index of Relative Socio-economic Advantage and Disadvantage [IRSAD; quintile 1, which refers to most disadvantaged areas, to quintile 5, which refers to least disadvantaged areas, and remoteness); (2) effectiveness, in which participant engagement and acceptability were evaluated using SMS text message reply data and a feedback survey (5-point Likert scale and free-text responses); (3) adoption, which corresponds to the proportion of organizations or health professionals who agreed to promote the program; (4) implementation fidelity and maintenance, which evaluated SMS text message delivery data, opt-outs, costs, and adaptations. Quantitative data were summarized using means and SDs or frequencies and percentages, while qualitative data were analyzed thematically. Results: With regard to the reach/representativeness of the program, 841/1340 (62.8%) participants enrolled and provided electronic consent. Participants had a mean age of 58.8 (SD 9.8; range 30-87) years. According to the data collected, most participants identified as female (837/840, 99.6%) and White (736/840, 87.6%) and nearly half (418/841, 49.7%) finished treatment ≤18 months ago. Most resided in major cities (574/838, 68.5%) and 30% (251/838) in IRSAD quintile 1 or 2. In terms of effectiveness, 852 replies were received from 511 unique participants (median 1; range 1-26). The most common replies were participants stating how they heard about the program (467/852, 54.8%) or “thank you” (131/852, 15.4%). None of the replies contained urgent safety concerns. Among participants who provided feedback (449/841, 53.4%), most “(strongly) agreed” the SMS text messages were easy to understand (445/448, 99.3%), useful (373/440, 84.8%), helped participants feel supported (388/448, 86.6%), and motivated participants to be physically active (312/445, 70.1%) and eat healthier (313/457, 68.5%). Free-text responses revealed 5 factors influencing engagement: (1) feeling supported and less alone, (2) motivation and reassurance for health self-management, (3) the variety of information, (4) weblinks to information and resources, and (5) the option to save the SMS text messages. Concerning adoption, 50% (18/36) of organizations/health professionals agreed to promote the program. With regard to implementation/maintenance, SMS text messages were delivered as planned (97.43% [41,257/42,344] of SMS text messages were successfully delivered) with minimal opt-outs (62/838, 7.4%) and low cost (Aus $15.40/participant; Aus $1=US $0.67). No adaptations were made during the intervention period. Postintervention adaptations included adding weblinks and participant-selected customizations. Conclusions: EMPOWER-SMS COVID-19 was implemented quickly, had a broad reach, and had high engagement and acceptability among socioeconomically diverse participants. The program had high fidelity, low cost, and required minimal staff oversight, which may facilitate future implementation. However, further research is needed to evaluate barriers and enablers to adoption and implementation for health professionals and strategies for long-term maintenance. %M 37490319 %R 10.2196/45164 %U https://www.jmir.org/2023/1/e45164 %U https://doi.org/10.2196/45164 %U http://www.ncbi.nlm.nih.gov/pubmed/37490319 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e44928 %T Supporting Children’s Social Connection and Well-Being in School-Age Care: Mixed Methods Evaluation of the Connect, Promote, and Protect Program %A Milton,Alyssa Clare %A Mengesha,Zelalem %A Ballesteros,Kristin %A McClean,Tom %A Hartog,Saskia %A Bray-Rudkin,Lucie %A Ngo,Cathy %A Hickie,Ian %+ Central Clinical School, Faculty of Medicine and Health, University of Sydney, Level 5 Professor Marie Bashir Building, Missenden Road, Camperdown, 2050, Australia, 61 2 8627 7240, alyssa.milton@sydney.edu.au %K participatory design %K evaluation %K children %K school-age care %K after-school care %K health %K well-being %K program development %K community consultation %D 2023 %7 25.7.2023 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: School-age care, such as outside school hours care (OSHC), is the fastest-growing childhood education sector in Australia. OSHC provides a unique opportunity to deliver programs to enhance primary school–age children’s social, emotional, physical, and cognitive well-being. Objective: This study aimed to pilot the co-designed Connect, Promote, and Protect Program (CP3) and conduct formative and process evaluations on how well the CP3 achieved its intended aims, ascertain areas for improvement, and determine how the CP3 model could be better sustained and extended into OSHC settings. Methods: A naturalistic formative and process evaluation of the CP3 implementation was undertaken at 1 and then 5 OSHC sites. Qualitative and quantitative feedback from stakeholders (eg, children, OSHC educators, volunteers, and families) was collected and incorporated iteratively for program improvement. Results: The formative and process evaluations demonstrated high program engagement, appropriateness, and acceptability. Co-design with children was viewed as highly acceptable and empowered children to be part of the decision-making in OSHC. Feedback highlighted how the CP3 supported children in the 4 CP3 domains: Build Well-being and Resilience, Broaden Horizons, Inspire and Engage, and Connect Communities. Qualitative reports suggested that children’s well-being and resilience were indirectly supported through the Broaden Horizons, Inspire and Engage, and Connect Communities CP3 principles. Matched-sample 2-tailed t tests found that children’s prosocial behaviors increased (mean difference=0.64; P=.04; t57=−2.06, 95% CI −1.36 to −0.02) and peer problems decreased (mean difference=−0.69; P=.01; t57=2.57, 95% CI 0.14-1.13) after participating in the CP3. Program feasibility was high but dependent on additional resources and CP3 coordinator support. Conclusions: To our knowledge, the CP3 is the first co-designed well-being program developed and evaluated specifically for OSHC services. This early evidence is promising. The CP3 may provide a unique opportunity to respond to the voices of children in OSHC and those that support them through creative and engaging co-designed activities. Our research suggests that CP3 provides OSHC with a framework and high-quality program planning tool that promotes tailored interventions developed based on the unique needs and preferences of those who will use them. %M 37490323 %R 10.2196/44928 %U https://pediatrics.jmir.org/2023/1/e44928 %U https://doi.org/10.2196/44928 %U http://www.ncbi.nlm.nih.gov/pubmed/37490323 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e40219 %T Co-design of an Augmented Reality Asthma Inhaler Educational Intervention for Children: Development and Usability Study %A O'Connor,Antonia %A Tai,Andrew %A Brinn,Malcolm %A Hoang,Amy Nguyen Thuc Hien %A Cataldi,Daniele %A Carson-Chahhoud,Kristin %+ Respiratory and Sleep Department, Women's and Children's Hospital, 72 King William Road, North Adelaide, Adelaide, 5006, Australia, 61 08 81617234, antonia.chan@sa.gov.au %K asthma %K asthma education %K pediatric %K pediatric asthma %K co-design %K usability %K development %K smartphone %K tablet %K augmented reality %K health education %K mobile app %K mobile phone %D 2023 %7 25.7.2023 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Smartphone and tablet apps that deliver health care education have been identified as effective in improving patient knowledge and treatment adherence in asthma populations. Despite asthma being the most common chronic disease in pediatrics, there are few apps that are targeted specifically for children. Only half of children with asthma have acceptable control of their symptoms, and 40%-98% do not use their inhalers correctly. With children being increasingly connected to technology, there is an opportunity to improve asthma inhaler technique education by delivery via smartphone or tablet apps. Augmented reality (AR) technology was used in this study to capitalize on growing technological innovations. Digital health interventions that use a co-design process for development have the highest likelihood of successful uptake and effectiveness on their intended outcomes. Perceived usability also has been shown to improve the effectiveness of education as well as the acceptance of the intervention. Objective: The aims of this study were to describe the co-design process, development, and design outcomes of a smartphone or tablet app that incorporates AR technology to deliver asthma inhaler technique education to children with asthma. This study also aimed to provide a usability evaluation, using the System Usability Scale to inform our work and future research, and recommendations for others performing similar work. Methods: The development of the AR asthma inhaler technique education app was based on an iterative co-design process with likely end users (children with asthma, their caregivers, and health care professionals). This involved multiple stages: recruitment of end users for qualitative interviews and usability testing with a previously designed educational intervention, which used an AR-embedded smartphone or tablet app; ideation of content for a specific asthma inhaler technique education intervention with end users; development of the specific asthma inhaler intervention; and 2 further rounds of interviews and usability testing with the redesign of the initial prototype. Results: We included 16 participants aged 9-45 years. Using the co-design process, the AR asthma inhaler technique education app was designed, incorporating the preferences of end users. After iteration 1, animation was included based on the feedback provided. Iteration 2 feedback resulted in increased AR experiences and the removal of the requirement of a paper-based resource to trigger AR in the third iteration. Throughout all rounds, the ease of use of the app and the novel nature of the intervention were frequently described. The usability of the intervention overall was perceived to be excellent, and the mean System Usability Scale score of the intervention was found to be highest in the final round of evaluation (90.14). Conclusions: The results from this co-design process and usability evaluation will be used to develop a final AR asthma inhaler technique educational intervention, which will be evaluated in the clinical setting. International Registered Report Identifier (IRRID): RR2-10.1177/16094069211042229 %M 37490325 %R 10.2196/40219 %U https://pediatrics.jmir.org/2023/1/e40219 %U https://doi.org/10.2196/40219 %U http://www.ncbi.nlm.nih.gov/pubmed/37490325 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e46200 %T A Novel and Integrated Digitally Supported System of Care for Depression and Anxiety: Findings From an Open Trial %A Wolitzky-Taylor,Kate %A LeBeau,Richard %A Arnaudova,Inna %A Barnes-Horowitz,Nora %A Gong-Guy,Elizabeth %A Fears,Scott %A Congdon,Eliza %A Freimer,Nelson %A Craske,Michelle %+ Department of Psychiatry and Biobehavioral Sciences, University of California - Los Angeles, 760 Westwood Blvd., Los Angeles, CA, 90025, United States, 1 3102675339, kbtaylor@mednet.ucla.edu %K depression %K anxiety %K cognitive behavioral therapy %K digital mental health %K stratified models of care %K model of care %K care model %K depressive %K mental health %K CBT %K psychotherapy %K university %K postsecondary %K student %K college %K service delivery %K care system %K system of care %K mHealth %K eHealth %K online support %K student mental health %D 2023 %7 24.7.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: The global burden of anxiety and depression has created an urgent need for scalable approaches to increase access to evidence-based mental health care. The Screening and Treatment for Anxiety and Depression (STAND) system of care was developed to meet this need through the use of internet-connected devices for assessment and provision of treatment. STAND triages to level of care (monitoring only, digital therapy with coaches, digital therapy assisted by clinicians in training, and clinical care) and then continuously monitors symptoms to adapt level of care. Triaging and adaptation are based on symptom severity and suicide risk scores obtained from computerized adaptive testing administered remotely. Objective: This article discusses how the STAND system of care improves upon current clinical paradigms, and presents preliminary data on feasibility, acceptability, and effectiveness of STAND in a sample of US-based university students. Methods: US-based university students were recruited and enrolled in an open trial of the STAND system of care. Participants were triaged based on initial symptom severity derived from a computerized adaptive test and monitored over 40 weeks on anxiety, depression, and suicide risk to inform treatment adaptation and evaluate preliminary effectiveness. Results: Nearly 5000 students were screened and 516 received care. Depression and anxiety severity scores improved across all tiers (P<.001 in all cases). Suicide risk severity improved in the highest tier (ie, clinical care; P<.001). Acceptability and feasibility were demonstrated. Conclusions: STAND is a feasible and acceptable model of care that can reach large numbers of individuals. STAND showed preliminary effectiveness on all primary outcome measures. Current directions to improve STAND are described. %M 37486735 %R 10.2196/46200 %U https://mental.jmir.org/2023/1/e46200 %U https://doi.org/10.2196/46200 %U http://www.ncbi.nlm.nih.gov/pubmed/37486735 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e46313 %T Digitally Based Blood Pressure Self-Monitoring Program That Promotes Hypertension Self-Management and Health Education Among Patients With Low-Income: Usability Study %A Poblete,Jacqueline Yareli %A Vawter,Natalie Lauren %A Lewis,Sydney Virginia %A Felisme,Earl Marc %A Mohn,Paloma Adriana %A Shea,Jennifer %A Northrup,Adam William %A Liu,Jie %A Al-Rousan,Tala %A Godino,Job Gideon %+ Laura Rodriguez Research Institute, Family Health Centers of San Diego, LRRI, 3rd Fl, 1750 Fifth Ave, San Diego, CA, 92101, United States, 1 619 515 2344, jobg@fhcsd.org %K hypertension %K blood pressure %K digital health %K health education %K self-measured blood pressure monitoring %K remote patient monitoring %D 2023 %7 24.7.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: According to evidence-based clinical guidelines, adults with hypertension are advised to self-monitor their blood pressure (BP) twice daily. Self-measured BP monitoring is a recommended strategy for improving hypertension management. Objective: We aimed to determine the feasibility and acceptability of a digitally based BP self-monitoring program that promotes hypertension self-management and health education among low-income patients. We hypothesized that the program would be highly feasible and acceptable and that at least 50% of the patients would use the monitor at the rate required for the reimbursement of the device’s cost (16 days of measurements in any 30-day period). Methods: Withings BPM Connect was deployed to patients at Family Health Centers of San Diego. Program elements included training, SMS text message reminders, and physician communication. Compliance, use, mean BP, and BP control status were calculated. A Kaplan-Meier time-to-event analysis was conducted to compare time to compliance between a strict definition (≥16 days in any rolling 30-day window) and a lenient definition (≥1 day per week for 4 consecutive weeks). A log-rank test was performed to determine whether the difference in time to compliance between the definitions was statistically significant. Mean systolic BP (SBP) and diastolic BP (DBP) before the intervention and after the intervention and mean change in SBP and DBP across patients were calculated. Paired sample t tests (2-tailed) were performed to assess the changes in SBP and DBP from before to after the intervention. Results: A total of 179 patients received the monitors. The mean changes in SBP and DBP from before to after the intervention were +2.62 (SE 1.26) mm Hg and +3.31 (SE 0.71) mm Hg, respectively. There was a statistically significant increase in both SBP and DBP after the intervention compared with before the intervention (P=.04 and P<.001). At the first and last measurements, 37.5% (63/168) and 48.8% (82/168) of the patients had controlled BP, respectively. During the observation period, 83.3% (140/168) of the patients had at least 1 controlled BP measurement. Use decreased over time, with 53.6% (90/168) of the patients using their monitor at week 2 and only 25% (42/168) at week 11. Although only 25.6% (43/168) achieved the strict definition of compliance, 42.3% (71/168) achieved the lenient definition of compliance. The median time to compliance was 130 days for the strict definition and 95 days for the lenient definition. The log-rank test showed a statistically significant difference in time to compliance between the compliance definitions (P<.001). Only 26.8% (45/168) complied with the measurement rate that would result in device cost reimbursement. Conclusions: Few patients used the monitors at a rate that would result in reimbursement, raising financial feasibility concerns. Plans for sustaining costs among low-income patients need to be further evaluated. %M 37486745 %R 10.2196/46313 %U https://humanfactors.jmir.org/2023/1/e46313 %U https://doi.org/10.2196/46313 %U http://www.ncbi.nlm.nih.gov/pubmed/37486745 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e45099 %T Using Intervention Mapping and Behavior Change Techniques to Develop a Digital Intervention for Self-Management in Stroke: Development Study %A Wong,Alex W K %A Fong,Mandy W M %A Munsell,Elizabeth G S %A Metts,Christopher L %A Lee,Sunghoon I %A Nicol,Ginger E %A DePaul,Olivia %A Tomazin,Stephanie E %A Kaufman,Katherine J %A Mohr,David C %+ Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, 355 E Erie St, Chicago, IL, 60611, United States, 1 312 238 1742, wwong@sralab.org %K mobile health %K digital intervention %K technology %K SMS text messaging %K intervention mapping %K behavior change %K self-management %K stroke %K rehabilitation %K mobile phone %D 2023 %7 24.7.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Digital therapeutics, such as interventions provided via smartphones or the internet, have been proposed as promising solutions to support self-management in persons with chronic conditions. However, the evidence supporting self-management interventions through technology in stroke is scarce, and the intervention development processes are often not well described, creating challenges in explaining why and how the intervention would work. Objective: This study describes a specific use case of using intervention mapping (IM) and the taxonomy of behavior change techniques (BCTs) in designing a digital intervention to manage chronic symptoms and support daily life participation in people after stroke. IM is an implementation science framework used to bridge the gap between theories and practice to ensure that the intervention can be implemented in real-world settings. The taxonomy of BCTs consists of a set of active ingredients designed to change self-management behaviors. Methods: We used the first 4 steps of the IM process to develop a technology-supported self-management intervention, interactive Self-Management Augmented by Rehabilitation Technologies (iSMART), adapted from a face-to-face stroke-focused psychoeducation program. Planning group members were involved in adapting the intervention. They also completed 3 implementation measures to assess the acceptability, appropriateness, and feasibility of iSMART. Results: In step 1, we completed a needs assessment consisting of assembling a planning group to codevelop the intervention, conducting telephone surveys of people after stroke (n=125) to identify service needs, and performing a systematic review of randomized controlled trials to examine evidence of the effectiveness of digital self-management interventions to improve patient outcomes. We identified activity scheduling, symptom management, stroke prevention, access to care resources, and cognitive enhancement training as key service needs after a stroke. The review suggested that digital self-management interventions, especially those using cognitive behavioral theory, effectively reduce depression, anxiety, and fatigue and enhance self-efficacy in neurological disorders. Step 2 identified key determinants, objectives, and strategies for self-management in iSMART, including knowledge, behavioral regulation, skills, self-efficacy, motivation, negative and positive affect, and social and environmental support. In step 3, we generated the intervention components underpinned by appropriate BCTs. In step 4, we developed iSMART with the planning group members. Especially, iSMART simplified the original psychoeducation program and added 2 new components: SMS text messaging and behavioral coaching, intending to increase the uptake by people after stroke. iSMART was found to be acceptable (mean score 4.63, SD 0.38 out of 5), appropriate (mean score 4.63, SD 0.38 out of 5), and feasible (mean score 4.58, SD 0.34 out of 5). Conclusions: We describe a detailed example of using IM and the taxonomy of BCTs for designing and developing a digital intervention to support people after stroke in managing chronic symptoms and maintaining active participation in daily life. %M 37486748 %R 10.2196/45099 %U https://humanfactors.jmir.org/2023/1/e45099 %U https://doi.org/10.2196/45099 %U http://www.ncbi.nlm.nih.gov/pubmed/37486748 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e44701 %T Comparing the Effectiveness of a Web-Based Application With a Digital Live Seminar to Improve Safe Communication for Pregnant Women: 3-Group Partially Randomized Controlled Trial %A Kötting,Lukas %A Derksen,Christina %A Keller,Franziska Maria %A Lippke,Sonia %+ Psychology & Methods, Constructor University, Campus Ring 1, Bremen, 28759, Germany, 49 421 200 4721, l.koetting@jacobs-university.de %K Health Action Process Approach %K HAPA %K intention %K safe communication behavior %K patient safety %K obstetric patients %K digital intervention %K web-based app %D 2023 %7 24.7.2023 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Medical internet interventions such as asynchronous apps and synchronous digital live seminars can be effective behavior change interventions. The research question of this study was whether digital interventions based on the Health Action Process Approach can improve pregnant women’s safe communication and patient safety in obstetric care. Objective: This study aims to compare a digital live seminar with a web-based application intervention and a passive control group and to identify which social cognitive variables determine safe communication behavior and patient safety. Methods: In total, 657 pregnant women were recruited, and hereof, 367 expectant mothers from 2 German university hospitals participated in the pre-post study (live seminar: n=142; web-based app: n=81; passive control group: n=144). All interventions targeted intention, planning, self-efficacy, and communication of personal preferences. The 2.5-hour midwife-assisted live seminar included exercises on empathy and clear communication. The fully automated web-based application consisted of 9 consecutive training lessons with the same content as that of the live seminar. Results: Controlled for sociodemographic characteristics, repeated measures analyses of covariance revealed that pregnant women significantly improved their self-reported communication behavior in all groups. The improvement was more pronounced after the digital live seminar than after the web-based application (P<.001; ηp2=0.043). Perceived patient safety improved more for pregnant women participating in the live seminar than for those participating in the web-based application group (P=.03 ηp2=0.015). A regression analysis revealed that social cognitive variables predicted safe communication behavior. Conclusions: Overall, the web-based application intervention appeared to be less effective than the digital live training in terms of communication behavior. Application interventions addressing communication behaviors might require more face-to-face elements. Improving intention, coping planning, and coping self-efficacy appeared to be key drivers in developing safe communication behavior in pregnant women. Future research should include social learning aspects and focus on the practical application of medical internet interventions when aiming to improve pregnant women’s communication and patient safety in obstetrics. Trial Registration: ClinicalTrials.gov NCT03855735; https://clinicaltrials.gov/ct2/show/NCT03855735 %M 37486755 %R 10.2196/44701 %U https://pediatrics.jmir.org/2023/1/e44701 %U https://doi.org/10.2196/44701 %U http://www.ncbi.nlm.nih.gov/pubmed/37486755 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47916 %T Personalized Integrated Care Promoting Quality of Life for Older People: Protocol for a Multicenter Randomized Controlled Trial %A Judica,Elda %A Tropea,Peppino %A Bouça-Machado,Raquel %A Marín,Mayca %A Calarota,Elisa %A Cozma,Liviu %A Badea,Raluca %A Ahmed,Mona %A Brach,Michael %A Ferreira,Joaquim J %A Corbo,Massimo %+ Department of Neurorehabilitation Sciences, Casa di Cura Igea, via Dezza, 48, Milan, 20144, Italy, 39 02 4859 3124, p.tropea@casadicuraigea.it %K Parkinson disease %K dementia %K neurodegenerative %K chronic diseases %K health care technologies %K integrated care %D 2023 %7 24.7.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Alzheimer disease (AD) and Parkinson disease (PD) are the 2 most common neurodegenerative diseases affecting millions of people worldwide. The Personalized Integrated Care Promoting Quality of Life for Older People (PC4L) project proposes an integrated, scalable, and interactive care ecosystem that can be easily adapted to the needs of several neurodegenerative and chronic diseases, care institutions, and end user requirements. Objective: The study protocol developed within the framework of the PC4L project aims to iteratively test the integrated platform and its modules, and focuses primarily on assessing the impact of the proposed solution (ie, the PC4L platform) on patients’ quality of life, as well as its usability and feasibility on a large-scale sample size in 3 different scenarios (home, neurorehabilitation, and day care centers). Methods: A prospective multicenter clinical study is conducted in 5 European countries (Germany, Italy, Portugal, Romania, and Spain) at 6 different pilot centers, for 3 months, in patients with PD, Parkinsonism, AD, and other dementias (ODs). Patients were randomized in a ratio of 1:1 to the intervention group (use of the PC4L system) or the control group (no intervention). The PC4L system consists mainly of a wristband for monitoring parameters such as steps and levels of physical activity, and the PC4L app, which includes different engaging functionalities. Both groups are assessed through baseline and end-of-study clinical evaluations, including assessment of quality of life through the EQ-5D-3L scale. Results: The study protocol is part of a project approved and funded by the European Commission Horizon 2020 (grant agreement number 875221). The ethics committees of all involved centers reviewed and approved the study protocol. The study began with the recruitment phase in September 2022, and enrollment ended in February 2023. Recruitment is now closed (April 2023). The results of this study are expected to be published in summer 2023. A total of 558 patients, 279 per study group, were recruited. The results will allow to clarify the impact of PC4L on quality of life, will assess the empowerment of patients and the medical resources use, as well as the usability of the final version of the PC4L system. It will also provide information on the support of the system as a tool to facilitate the decision-making process. Conclusions: The PC4L project intends to test a technology-based, integrated, scalable, and interactive care platform on patients with neurodegenerative diseases and proposes a good coordinated care model between all involved actors. Future developments of the PC4L solution may involve caregivers and socio-health professionals in the decision-making process in order to facilitate efficient communication between all stakeholders and ensure reliable and protected access to data within Europe. Trial Registration: ClinicalTrials.gov NCT05538455; https://clinicaltrials.gov/study/NCT05538455 International Registered Report Identifier (IRRID): DERR1-10.2196/47916 %M 37486732 %R 10.2196/47916 %U https://www.researchprotocols.org/2023/1/e47916 %U https://doi.org/10.2196/47916 %U http://www.ncbi.nlm.nih.gov/pubmed/37486732 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e47285 %T The Impact of a Gamified Mobile Mental Health App (eQuoo) on Resilience and Mental Health in a Student Population: Large-Scale Randomized Controlled Trial %A Litvin,Silja %A Saunders,Rob %A Jefferies,Philip %A Seely,Hayley %A Pössel,Patrick %A Lüttke,Stefan %+ Department Psychologie, Ludwig-Maximilians-Universität, Geschwister-Scholl-Platz 1, München, 80539, Germany, 49 89 21800, silja@psycapps.com %K mobile health %K mHealth %K gamification %K resilience %K randomized controlled trial %K RCT %K mental health %K apps %K mobile health %K mobile game %K mobile games %K serious game %K depression %K anxiety %K university %K college %K student %K students %K controlled trial %K controlled trials %K young adult %K mobile phone %D 2023 %7 21.7.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: With many digital mental health interventions failing to engage clients for enough time to demonstrate substantive changes to their well-being and with only 2% of all digital solutions on app stores having undergone randomized controlled trials, the rising demand for mental health prevention and early intervention care is not being met. Young adults in particular struggle to find digital well-being apps that suit their needs. Objective: This study explored the effects of eQuoo, an evidence-based mental health game that teaches psychological skills through gamification, on resilience, depression, anxiety, and attrition in a student population. Methods: In total, 1165 students from 180 universities in the United Kingdom participated in a 5-week, 3-armed randomized controlled trial. Participants were randomly allocated into 1 of 3 groups: eQuoo users, users of a treatment-as-usual evidence-based cognitive behavioral health app called Sanvello, and a no-intervention waitlist. The Rugged Resilience Scale, Generalized Anxiety Disorder–7, and Patient Health Questionnaire–8 were administered to all participants at baseline and every 7 days until completion. Results: A repeated measures–ANOVA revealed statistically significant increases in resilience scores in the test group (P<.001) compared with both control groups (Sanvello: P=.10 and waitlist: P=.82) over 5 weeks. The app also significantly decreased anxiety and depression scores (both P<.001). With 64.5% (251/389) adherence, the eQuoo group retained 42% more participants than the control groups. Conclusions: Digital health interventions such as eQuoo are effective, scalable, and low-cost solutions for supporting young adults and are available on all leading mobile platforms. Further investigation could clarify the extent to which specific elements of the eQuoo app (including gamification) led to better outcomes. Trial Registration: German Clinical Trials Register (DRKS) DRKS00027638; https://drks.de/search/en/trial/DRKS00027638 %M 37477955 %R 10.2196/47285 %U https://mental.jmir.org/2023/1/e47285 %U https://doi.org/10.2196/47285 %U http://www.ncbi.nlm.nih.gov/pubmed/37477955 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 9 %N %P e44914 %T A Web-Based Cancer Self-Management Program (I-Can Manage) Targeting Treatment Toxicities and Health Behaviors: Human-Centered Co-design Approach and Cognitive Think-Aloud Usability Testing %A Howell,Doris %A Bryant Lukosius,Denise %A Avery,Jonathan %A Santaguida,Athina %A Powis,Melanie %A Papadakos,Tina %A Addario,Vincenzo %A Lovas,Mike %A Kukreti,Vishal %A Haase,Kristen %A Mayo,Samantha J %A Papadakos,Janet %A Moradian,Saeed %A Krzyzanowska,Monika K %+ Department of Supportive Care, Princess Margaret Cancer Research Institute, Princess Margaret Cancer Centre, 690 University Ave, Toronto, ON, M5G2M9, Canada, 1 6472277261, doris.howell@uhn.ca %K web-based program %K self-management %K cancer treatment %K digital technology %K co-design %K usability %D 2023 %7 21.7.2023 %9 Original Paper %J JMIR Cancer %G English %X Background: Patients with cancer require adequate preparation in self-management of treatment toxicities to reduce morbidity that can be achieved through well-designed digital technologies that are developed in co-design with patients and end users. Objective: We undertook a user-centered co-design process in partnership with patients and other knowledge end users to develop and iteratively test an evidence-based and theoretically informed web-based cancer self-management program (I-Can Manage). The specific study aims addressed in 2 phases were to (1) identify from the perspective of patients with cancer and clinicians the desired content, features, and functionalities for an online self-management education and support (SMES) program to enable patient self-management of treatment toxicities (phase 1); (2) develop the SMES prototype based on human-centered, health literate design principles and co-design processes; and (3) evaluate usability of the I-Can Manage prototype through user-centered testing (phase 2). Methods: We developed the I-Can Manage program using multiperspective data sources and based on humanistic and co-design principles with end users engaged through 5 phases of development. We recruited adult patients with lung, colorectal, and lymphoma cancer receiving systemic treatments from ambulatory clinics in 2 regional cancer programs for the qualitative inquiry phase. The design of the program was informed by data from qualitative interviews and focus groups, persona and journey mapping, theoretical underpinnings of social cognitive learning theory, and formalized usability testing using a cognitive think-aloud process and user satisfaction survey. A co-design team comprising key stakeholders (human design experts, patients/caregiver, clinicians, knowledge end users, and e-learning and digital design experts) was involved in the developmental process. We used a cognitive think-aloud process to test usability and participants completed the Post-Study System Usability Questionnaire (PSSUQ). Results: In the initial qualitative inquiry phase, 16 patients participated in interviews and 19 clinicians participated in interviews or focus groups and 12 key stakeholders participated in a persona journey mapping workshop to inform development of the program prototype. The I-Can Manage program integrates evidence-based information and strategies for the self-management of treatment toxicities and health-promoting behaviors in 6 e-learning modules (lay termed “chapters”), starting with an orientation to self-management. Behavioral exercises, patient written and video stories, downloadable learning resources, and online completion of goals and action plans were integrated across chapters. Patient participants (n=5) with different cancers, gender, and age worked through the program in the human factors laboratory using a cognitive think-aloud process and all key stakeholders reviewed each chapter of the program and approved revisions. Results of the PSSUQ (mean total score: 3.75) completed following the cognitive think-aloud process (n=5) suggest patient satisfaction with the usability of I-Can Manage. Conclusions: The I-Can Manage program has the potential for activating patients in self-management of cancer and treatment toxicities but requires testing in a larger randomized controlled trial. %M 37477968 %R 10.2196/44914 %U https://cancer.jmir.org/2023/1/e44914 %U https://doi.org/10.2196/44914 %U http://www.ncbi.nlm.nih.gov/pubmed/37477968 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 7 %N %P e43940 %T Preliminary Efficacy, Feasibility, and Perceived Usefulness of a Smartphone-Based Self-Management System With Personalized Goal Setting and Feedback to Increase Step Count Among Workers With High Blood Pressure: Before-and-After Study %A Shibuta,Tomomi %A Waki,Kayo %A Miyake,Kana %A Igarashi,Ayumi %A Yamamoto-Mitani,Noriko %A Sankoda,Akiko %A Takeuchi,Yoshinori %A Sumitani,Masahiko %A Yamauchi,Toshimasa %A Nangaku,Masaomi %A Ohe,Kazuhiko %+ Department of Healthcare Information Management, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan, 81 3 5800 9129, kwaki-tky@m.u-tokyo.ac.jp %K behavior change %K blood pressure %K feasibility studies %K goal setting %K mobile health %K mHealth %K self-control %K self-efficacy %K self-regulation %K smartphone %K step count %K walking %K workplace %K mobile phone %D 2023 %7 21.7.2023 %9 Original Paper %J JMIR Cardio %G English %X Background: High blood pressure (BP) and physical inactivity are the major risk factors for cardiovascular diseases. Mobile health is expected to support patients’ self-management for improving cardiovascular health; the development of fully automated systems is necessary to minimize the workloads of health care providers. Objective: The objective of our study was to evaluate the preliminary efficacy, feasibility, and perceived usefulness of an intervention using a novel smartphone-based self-management system (DialBetes Step) in increasing steps per day among workers with high BP. Methods: On the basis of the Social Cognitive Theory, we developed personalized goal-setting and feedback functions and information delivery functions for increasing step count. Personalized goal setting and feedback consist of 4 components to support users’ self-regulation and enhance their self-efficacy: goal setting for daily steps, positive feedback, action planning, and barrier identification and problem-solving. In the goal-setting component, users set their own step goals weekly in gradual increments based on the system’s suggestion. We added these fully automated functions to an extant system with the function of self-monitoring daily step count, BP, body weight, blood glucose, exercise, and diet. We conducted a single-arm before-and-after study of workers with high BP who were willing to increase their physical activity. After an educational group session, participants used only the self-monitoring function for 2 weeks (baseline) and all functions of DialBetes Step for 24 weeks. We evaluated changes in steps per day, self-reported frequencies of self-regulation and self-management behavior, self-efficacy, and biomedical characteristics (home BP, BMI, visceral fat area, and glucose and lipid parameters) around week 6 (P1) of using the new functions and at the end of the intervention (P2). Participants rated the usefulness of the system using a paper-based questionnaire. Results: We analyzed 30 participants (n=19, 63% male; mean age 52.9, SD 5.3 years); 1 (3%) participant dropped out of the intervention. The median percentage of step measurement was 97%. Compared with baseline (median 10,084 steps per day), steps per day significantly increased at P1 (median +1493 steps per day; P<.001), but the increase attenuated at P2 (median +1056 steps per day; P=.04). Frequencies of self-regulation and self-management behavior increased at P1 and P2. Goal-related self-efficacy tended to increase at P2 (median +5%; P=.05). Home BP substantially decreased only at P2. Of the other biomedical characteristics, BMI decreased significantly at P1 (P<.001) and P2 (P=.001), and high-density lipoprotein cholesterol increased significantly only at P1 (P<.001). DialBetes Step was rated as useful or moderately useful by 97% (28/29) of the participants. Conclusions: DialBetes Step intervention might be a feasible and useful way of increasing workers’ step count for a short period and, consequently, improving their BP and BMI; self-efficacy–enhancing techniques of the system should be improved. %M 37477976 %R 10.2196/43940 %U https://cardio.jmir.org/2023/1/e43940 %U https://doi.org/10.2196/43940 %U http://www.ncbi.nlm.nih.gov/pubmed/37477976 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 8 %N %P e44943 %T User Retention and Engagement in the Digital-Based Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (myDESMOND) Program: Descriptive Longitudinal Study %A Barker,Mary M %A Chauhan,Radhika %A Davies,Melanie J %A Brough,Christopher %A Northern,Alison %A Stribling,Bernie %A Schreder,Sally %A Khunti,Kamlesh %A Hadjiconstantinou,Michelle %+ Diabetes Research Centre, University of Leicester, NIHR Leicester Biomedical Research Centre, Leicester Diabetes Centre, Leicester, LE4 5PW, United Kingdom, 44 116 2584320, mh333@le.ac.uk %K retention %K engagement %K digital self-management %K type 2 diabetes %K mobile phone %D 2023 %7 21.7.2023 %9 Original Paper %J JMIR Diabetes %G English %X Background: Digital health interventions have the potential to improve the physical and psychosocial health of people living with type 2 diabetes. However, research investigating the long-term (≥1 year) retention and engagement of users within these programs is limited. Objective: The aim of this study was to evaluate long-term user retention and engagement in the digital-based Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (myDESMOND) program, using real-world data. Methods: Anonymized data from all myDESMOND users who registered with the program on or before November 16, 2020, were included in the analyses. User retention was defined as the period between the day a user registered with the myDESMOND program and their last day of access. The primary engagement outcome was defined as the total number of log-ins to the program per user. The associations between retention, engagement, and sociodemographic factors (age, sex, and ethnicity) were tested using Cox regression models and Wilcoxon rank sum tests. Results: A total of 9522 myDESMOND users were included in this analysis. Of the 9522 users, 5360 (56.29%) remained on the program for at least a month, whereas 1676 (17.6%) remained on the program for at least 1 year. Retention was significantly higher among older users; the adjusted hazard ratio (representing the risk of users leaving the program within the first year) among users aged ≥50 years, compared with those aged <50 years, was 0.79 (95% CI 0.75-0.84; P<.001). The median number of myDESMOND log-ins per user was 8 (IQR 4-8); however, this was significantly lower among users aged <50 years (P<.001). Engagement metrics also differed according to sociodemographic characteristics; the estimated time spent per log-in was 5.35 (IQR 2.22-11.80) minutes among all users; however, this was significantly higher among female users (P<.001), users aged ≥50 years (P<.001), and users of White ethnicity (P=.02). Conclusions: Although retention and engagement of users within myDESMOND were found to be high, these findings highlight the need for age- and culture-specific implementation strategies and content adaptations to improve retention and engagement among all users of self-management programs. %M 37477963 %R 10.2196/44943 %U https://diabetes.jmir.org/2023/1/e44943 %U https://doi.org/10.2196/44943 %U http://www.ncbi.nlm.nih.gov/pubmed/37477963 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47121 %T Behavioral Economic Strategies to Improve Enrollment Rates in Clinical Research: Embedded Recruitment Pilot Trial %A Greene,Brittney %A Bernardo,Leah %A Thompson,Morgan %A Loughead,James %A Ashare,Rebecca %+ State University of New York at Buffalo, 334 Diefendorf Hall, Buffalo, NY, 14214, United States, 1 7168296273, rlashare@buffalo.edu %K behavior change %K behavioral economics %K clinical trials %K contingency management %K evidence based %K information provision %K recruitment %K retention %K SMS text messaging %K study within a trial %K SWAT %D 2023 %7 21.7.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Nearly 1 in 3 clinical trials end prematurely due to underenrollment. Strategies to enhance recruitment are often implemented without scientific rigor to evaluate efficacy. Evidence-based, cost-effective behavioral economic strategies designed to influence decision-making may be useful to promote clinical trial enrollment. Objective: This study evaluated 2 behavioral economic strategies to improve enrollment and retention rates across 4 clinical trials: information provision (IP) and contingency management (CM; ie, lottery). IP targets descriptive and injunctive norms about participating in research and CM provides participants incentives to reinforce a target behavior. Methods: A sample of 212 participants was enrolled across 4 clinical trials focused on tobacco use: 2 focused on HIV and 2 focused on neuroimaging. The CM condition included a lottery: for each study visit completed, participants received 5 “draws” from a bowl containing 500 “chips” valued at US $0, US $1, US $5, or US $100. In the IP condition, text messages that targeted injunctive norms about research (eg, “Many find it a rewarding way to advance science and be part of a community”) were sent through the Way to Health platform before all study visits. Participants were randomized to 1 of 4 conditions: IP, CM, IP+CM, or standard recruitment (SR). We performed logistic regression, controlling for sex and study, with condition as a between-subject predictor. Outcomes were the percentage of participants who attended a final eligibility visit (primary), met intent-to-treat (ITT) criteria (secondary), and completed the study (secondary). Recruitment was evaluated by the percentage of participants who attended a final eligibility visit, enrollment by ITT status, and retention by the percentage of participants who completed the study. Results: Rates of attending the eligibility visit and meeting ITT status were 58.9% (33/56) and 33.9% (19/56) for IP+CM; 45.5% (25/55) and 18.2% (10/55) for IP only; 41.5% (22/53) and 18.9% (10/53) for CM only; and 37.5% (18/48) and 12.5% (6/48) for SR, respectively. In the logistic regression, females were more likely to meet ITT status than males (odds ratio [OR] 2.7, 95% CI 1.2-5.7; P=.01). The IP+CM group was twice as likely to attend the final eligibility visit than the SR group (OR 2.4, 95% CI 1.1-5.2; P=.04). The IP+CM group was also significantly more likely to reach ITT status than the SR condition (OR 3.9, 95% CI 1.3-11.1; P=.01). Those who received any active intervention (IP, CM, or IP+CM) had a higher study completion rate (33/53, 63.5%) compared to those who received SR (5/12, 41.7%), but this difference was not significant (P=.26). Conclusions: Combining IP and CM strategies may motivate participants to participate in research and improve recruitment and retention rates. Evidence from this study provides preliminary support for the utility of behavioral economics strategies to improve enrollment and reduce attrition in clinical trials. %M 37477975 %R 10.2196/47121 %U https://formative.jmir.org/2023/1/e47121 %U https://doi.org/10.2196/47121 %U http://www.ncbi.nlm.nih.gov/pubmed/37477975 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e36132 %T Social Media Interventions for Nutrition Education Among Adolescents: Scoping Review %A Kulandaivelu,Yalinie %A Hamilton,Jill %A Banerjee,Ananya %A Gruzd,Anatoliy %A Patel,Barkha %A Stinson,Jennifer %+ Child Health Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning, 686 Bay Street, Toronto, ON, M5G 0A4, Canada, 1 416 813 7654 ext 327105, yalinie.kulandaivelu@mail.utoronto.ca %K adolescents %K digital health intervention %K food literacy %K health literacy %K nutrition %K peer education %K peer support %K social media %D 2023 %7 20.7.2023 %9 Review %J JMIR Pediatr Parent %G English %X Background: Adolescence is a critical period for reinforcing healthy dietary behaviors and supporting the development of cooking skills. Social media may be an avenue for supporting these behaviors, as it is popular among adolescents and can improve access to nutrition education interventions. This study sought to understand the optimal implementation of effective social media–based nutrition education interventions to inform the implementation of future social media–based nutrition education interventions. Objective: A scoping review of the characteristics, feasibility, effectiveness, and factors influencing social media–based nutrition education interventions for adolescents was conducted. Methods: We searched MEDLINE, Embase, CINAHL, Web of Science, and PsycINFO databases using a predefined search strategy. Primary research articles were independently screened and included if they involved adolescent populations (10-18 years old) and delivered nutrition education through social media. The information on intervention characteristics, feasibility, effectiveness, and factors influencing social media–based nutrition education interventions was extracted. Results: A total of 28 publications out of 20,557 met the eligibility criteria. Twenty-five nutrition interventions were examined by 28 studies. Fourteen interventions used homegrown social media platforms, 8 used Facebook, and 2 used Instagram. Feasibility outcomes were infrequently reported, and the cost of intervention delivery was not reported. Engagement with interventions was variable; high engagement was not required to elicit significant improvements in dietary behaviors. Tailoring interventions, offering practical content, meaningful peer support, and involving families and communities facilitated successful interventions. Strategies to address engagement and technical issues were varied. Conclusions: Emerging evidence demonstrates that social media interventions for adolescent nutrition are acceptable and improve nutrition outcomes. Future interventions should strengthen peer support components and tailor delivery to specific populations. Further research should examine engagement, adherence, and the impact of interventions on behavioral and physical outcomes. This review is the first to examine the use of social media as the primary medium for nutrition education for adolescent populations. The analysis used in this review argues the importance of peer support in social media–based nutrition interventions and the need for user-centered design of the interventions. %M 37471119 %R 10.2196/36132 %U https://pediatrics.jmir.org/2023/1/e36132 %U https://doi.org/10.2196/36132 %U http://www.ncbi.nlm.nih.gov/pubmed/37471119 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 12 %N %P e40205 %T Improving Predictability and Effectiveness in Preventive Digital Health Interventions: Scoping Review %A Pedersen,Keld %A Schlichter,Bjarne Rerup %+ Information Systems, Department of Management, Aarhus University, Bartholins Allé 14, Aarhus C, 8000, Denmark, 45 51157818, keldp@mgmt.au.dk %K mobile health %K mHealth %K digital interventions %K adoption %K implementation %K prevention %K physical activity %K diet %K mobile phone %K scoping review %K review %D 2023 %7 20.7.2023 %9 Review %J Interact J Med Res %G English %X Background: Lifestyle-related diseases caused by inadequate diet and physical activity cause premature death, loss of healthy life years, and increased health care costs. Randomized controlled trial (RCT) studies indicate that preventive digital health interventions (P-DHIs) can be effective in preventing these health problems, but the results of these studies are mixed. Adoption studies have identified multiple factors related to individuals and the context in which they live that complicate the transfer of positive results from RCT studies to practical use. Implementation studies have revealed barriers to the large-scale implementation of mobile health (mHealth) solutions in general. Consequently, there is no clear path to delivering predictable outcomes from P-DHIs and achieving effectiveness when scaling up interventions to reduce health problems in society. Objective: This research aimed to expand our understanding of how to increase the outcome predictability of P-DHIs by focusing on physical activity and diet behaviors and amplify our understanding of how to improve effectiveness in large-scale implementations. Methods: The research objective was pursued through a multidisciplinary scoping review. This scoping review used the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) as a guide. A comprehensive search of Web of Science and PubMed limited to English-language journal articles published before January 2022 was conducted. Google Scholar was used for hand searches. Information systems theory was used to identify key constructs influencing outcomes of IT in general. Public health and mHealth literature were used to identify factors influencing the adoption of, outcomes from, and implementation of P-DHIs. Finally, the P-DHI investment model was developed based on information systems constructs and factors from the public health and mHealth literature. Results: In total, 203 articles met the eligibility criteria. The included studies used a variety of methodologies, including literature reviews, interviews, surveys, and RCT studies. The P-DHI investment model suggests which constructs and related factors should be emphasized to increase the predictability of P-DHI outcomes and improve the effectiveness of large-scale implementations. Conclusions: The research suggests that outcome predictability could be improved by including descriptions of the constructs and factors in the P-DHI investment model when reporting from empirical studies. Doing so would increase our understanding of when and why P-DHIs succeed or fail. The effectiveness of large-scale implementations may be improved by using the P-DHI investment model to evaluate potential difficulties and possibilities in implementing P-DHIs to create better environments for their use before investing in them and when designing and implementing them. The cost-effectiveness of large-scale implementations is unknown; implementations are far more complicated than just downloading and using apps, and there is uncertainty accompanying implementations given the lack of coordinated control over the constructs and factors that influence the outcome. %M 37471129 %R 10.2196/40205 %U https://www.i-jmr.org/2023/1/e40205 %U https://doi.org/10.2196/40205 %U http://www.ncbi.nlm.nih.gov/pubmed/37471129 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47851 %T Mobile Web App Intervention to Promote Breast Cancer Screening Among American Indian Women in the Northern Plains: Feasibility and Efficacy Study %A Roh,Soonhee %A Lee,Yeon-Shim %A Kenyon,DenYelle B %A Elliott,Amy J %A Petereit,Daniel G %A Gaba,Anu %A Lee,Hee Yun %+ Department of Social Work, University of South Dakota, 4801 N Career Ave, 145C, Sioux Falls, SD, 57107, United States, 1 6053571593, soonhee.roh@usd.edu %K American Indian women %K breast cancer %K mammogram %K mHealth %K mobile web app intervention %D 2023 %7 20.7.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Breast cancer is the most common cancer in the United States and the second leading cause of death for American Indian women. American Indian women have lower rates of breast cancer screening than other racial groups, and disparities in breast cancer mortality and survival rates persist among them. To address this critical need, a culturally appropriate, accessible, and personalized intervention is necessary to promote breast cancer screening among American Indian women. This study used mobile health principles to develop a mobile web app-based mammogram intervention (wMammogram) for American Indian women in a remote, rural community in the Northern Plains. Objective: This study aimed to assess the feasibility and efficacy of the wMammogram intervention, which was designed to motivate American Indian women to undergo breast cancer screening, as compared with the control group, who received an educational brochure. Methods: Using community-based participatory research (CBPR) principles and a multipronged recruitment strategy in a randomized controlled trial design, we developed the wMammogram intervention. This study involved 122 American Indian women aged between 40 and 70 years, who were randomly assigned to either the intervention group (n=62) or the control group (n=60). Those in the intervention group received personalized and culturally appropriate messages through a mobile web app, while those in the control group received an educational brochure. We measured outcomes such as mammogram receipt, intention to receive breast cancer screening after the intervention, and participants’ satisfaction with and acceptance of the intervention. Results: A significantly higher proportion of women who received the wMammogram intervention (26/62, 42%; P=.009) completed mammograms by the 6-month follow-up than the control group (12/60, 20%). The wMammogram intervention group, compared with the control group, reported significantly higher ratings on perceived effectiveness of the intervention (t120=−5.22; P<.001), increase in knowledge (t120=−4.75; P<.001), and satisfaction with the intervention (t120=−3.61; P<.001). Moreover, compared with the brochure group, the intervention group expressed greater intention to receive a mammogram in the future when it is due (62/62, 100% vs 51/60, 85%) and were more willing to recommend the intervention they received to their friends (61/62, 98.4% vs 54/60, 90%) with statistically significant differences. Conclusions: This study shows the feasibility and efficacy of the wMammogram intervention to promote breast cancer screening for American Indian women in a remote, rural community-based setting. Findings suggest that, with advancements in technology and the ubiquity of mobile devices, mobile web apps could serve as a valuable health intervention tool that builds upon low-cost technology and enhances accessibility and sustainability of preventive care to help reduce breast health disparities experienced in hard-to-reach American Indian populations. Trial Registration: ClinicalTrials.gov NCT05530603; https://clinicaltrials.gov/ct2/show/NCT05530603 %M 37471115 %R 10.2196/47851 %U https://formative.jmir.org/2023/1/e47851 %U https://doi.org/10.2196/47851 %U http://www.ncbi.nlm.nih.gov/pubmed/37471115 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44362 %T A Mobile Clinical Decision Support System for High-Risk Pregnant Women in Rural India (SMARThealth Pregnancy): Pilot Cluster Randomized Controlled Trial %A Nagraj,Shobhana %A Kennedy,Stephen %A Jha,Vivekananda %A Norton,Robyn %A Hinton,Lisa %A Billot,Laurent %A Rajan,Eldho %A Mohammed Abdul,Ameer %A Phalswal,Anita %A Arora,Varun %A Praveen,Devarsetty %A Hirst,Jane %+ Health Systems Collaborative, Nuffield Department of Medicine, University of Oxford, The Peter Medawar Building for Pathogen Research, South Parks Road, Oxford, OX1 3SY, United Kingdom, 44 1865 281231, shobhana.nagraj@ndm.ox.ac.uk %K decision support systems %K clinical %K telemedicine %K community health workers %K pregnancy %K high risk %K diabetes %K gestational %K cardiovascular diseases %D 2023 %7 20.7.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Cardiovascular disease (CVD) is the leading cause of death in women in India. Early identification is crucial to reducing deaths. Hypertensive disorders of pregnancy (HDP) and gestational diabetes mellitus (GDM) carry independent risks for future CVD, and antenatal care is a window to screen and counsel high-risk women. In rural India, community health workers (CHWs) deliver antenatal and postnatal care. We developed a complex intervention (SMARThealth Pregnancy) involving mobile clinical decision support for CHWs and evaluated it in a pilot cluster randomized controlled trial (cRCT). Objective: The aim of the study is to co-design a theory-informed intervention for CHWs to screen, refer, and counsel pregnant women at high risk of future CVD in rural India and evaluate its feasibility and acceptability. Methods: In phase 1, we used qualitative methods to explore community priorities for high-risk pregnant women in rural areas of 2 diverse states in India. In phase 2, informed by behavior change theory and human-centered design, we used these qualitative data to develop the intervention components and implementation strategies for SMARThealth Pregnancy in an iterative process with end users. In phase 3, using mixed methods, we evaluated the intervention in a cRCT with an embedded qualitative substudy across 4 primary health centres: 2 in Jhajjar district, Haryana, and 2 in Guntur district, Andhra Pradesh. Results: SMARThealth Pregnancy embedded a total of 15 behavior change techniques and included (1) community awareness programs; (2) targeted training, including point-of-care blood pressure and hemoglobin measurement; and (3) mobile clinical decision support for CHWs to screen women in their homes. The intervention focused on 3 priority conditions: anemia, HDP, and GDM. The evaluation involved a total of 200 pregnant women, equally randomized to intervention or enhanced standard care (control). Recruitment was completed within 5 months, with minimal loss to follow-up (4/200, 2%) at 6 weeks postpartum. A total of 4 primary care doctors and 54 CHWs in the intervention clusters took part in the study. Fidelity to intervention practices was 100% prepandemic. Over half the study population was affected by moderate to severe anemia at baseline. The prevalence of HDP (2.5%) and GDM (2%) was low in our study population. Results suggest a possible improvement in mean hemoglobin (anemia) in the intervention group, although an adequately powered trial is needed. The model of home-based care was feasible and acceptable for pregnant or postpartum women and CHWs, who perceived improvements in quality of care, self-efficacy, and professional recognition. Conclusions: SMARThealth Pregnancy is an innovative model of home-based care for high-risk pregnant women during the transitions between antenatal and postnatal care and adult health services. The use of theory and co-design during intervention development facilitated acceptability of the intervention and implementation strategies. Our experience has informed the decision to initiate a larger-scale cRCT. Trial Registration: ClinicalTrials.gov NCT03968952; https://clinicaltrials.gov/ct2/show/NCT03968952 International Registered Report Identifier (IRRID): RR2-10.3389/fgwh.2021.620759 %M 37471135 %R 10.2196/44362 %U https://formative.jmir.org/2023/1/e44362 %U https://doi.org/10.2196/44362 %U http://www.ncbi.nlm.nih.gov/pubmed/37471135 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47636 %T Reduction of Sleep Medications via a Combined Digital Insomnia and Pharmacist-Led Deprescribing Intervention: Protocol for a Feasibility Trial %A Bramoweth,Adam D %A Hough,Caroline E %A McQuillan,Amanda D %A Spitznogle,Brittany L %A Thorpe,Carolyn T %A Lickel,James J %A Boudreaux-Kelly,Monique %A Hamm,Megan E %A Germain,Anne %+ Mental Illness Research, Education and Clinical Center, VA Pittsburgh Healthcare System, Research Office Building (151RU), University Drive C, Pittsburgh, PA, 15240, United States, 1 412 360 2806, adam.bramoweth@va.gov %K insomnia %K sedatives and hypnotics %K mHealth %K deprescribing %K cognitive behavioral therapy %K clinical pharmacist %K veterans %D 2023 %7 20.7.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic insomnia is one of the most common health problems among veterans and negatively impacts their health, function, and quality of life. Although cognitive behavioral therapy for insomnia (CBT-I) is the first-line recommended treatment, sedative-hypnotic medications remain the most common. Sedative-hypnotics, however, have mixed effectiveness, are frequently prescribed longer than recommended, and are associated with numerous risks and adverse effects that negatively impact veteran function. Meeting the treatment needs of veterans impacted by insomnia requires delivering gold standard behavioral care, like CBT-I, and the reduction of sedative-hypnotics through innovative methods. Objective: The objective of this feasibility clinical trial is to test a digital CBT-I approach combined with deprescribing to improve the success of sedative-hypnotic reduction among veterans. The intervention combines Noctem Health Clinician Operated Assistive Sleep Technology (COAST), an effective and efficient, scalable, and adaptable digital platform to deliver CBT-I, with clinical pharmacy practitioner (CPP)–led deprescribing of sedative-hypnotic medications. Methods: In this nonrandomized single-group clinical trial, 50 veterans will be recruited and enrolled to receive CBT-I delivered via Noctem COAST and CPP-led deprescribing for up to 12 weeks. Assessments will occur at baseline, posttreatment, and 3-month follow-up. The aims are to (1) assess the feasibility of recruiting veterans with chronic sedative-hypnotic use to participate in the combined intervention, (2) evaluate veterans’ acceptability and usability of the COAST platform, and (3) measure changes in veterans’ sleep, sedative-hypnotic use, and function at baseline, posttreatment, and 3-month follow-up. Results: The institutional review board approved the study in October 2021 and the trial was initiated in May 2022. Recruitment and data collection began in September 2022 and is anticipated to be completed in April 2024. Aim 1 will be measured by tracking the response to a mail-centric recruitment approach using electronic medical records to identify potentially eligible veterans based on sedative-hypnotic use. Aim 2 will be measured using the Post-Study System Usability Questionnaire, assessing overall usability as well as system usefulness, information quality, and interface quality. Aim 3 will use the Insomnia Severity Index and sleep diaries to measure change in insomnia outcomes, the Patient-Reported Outcome Measurement Information System Profile to measure change in physical function, anxiety, depression, fatigue, sleep disturbance, participation in social roles, pain, cognitive function, and self-reported sedative-hypnotic use to measure change in dose and frequency of use. Conclusions: Findings will inform the utility of a combined digital CBT-I and CPP-led deprescribing intervention and the development of an adequately powered clinical trial to test the effectiveness in a diverse sample of veterans. Further, findings will help inform potential new approaches to deliver care and improve access to care for veterans with insomnia, many of whom use sedative-hypnotics that may be ineffective and increase the risk for negative outcomes. Trial Registration: ClinicalTrials.gov NCT05027438; https://classic.clinicaltrials.gov/ct2/show/NCT05027438 International Registered Report Identifier (IRRID): DERR1-10.2196/47636 %M 37471122 %R 10.2196/47636 %U https://www.researchprotocols.org/2023/1/e47636 %U https://doi.org/10.2196/47636 %U http://www.ncbi.nlm.nih.gov/pubmed/37471122 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45975 %T Effect of a Wearable Device–Based Physical Activity Intervention in North Korean Refugees: Pilot Randomized Controlled Trial %A Kim,Ji Yoon %A Kim,Kyoung Jin %A Kim,Kyeong Jin %A Choi,Jimi %A Seo,Jinhee %A Lee,Jung-Been %A Bae,Jae Hyun %A Kim,Nam Hoon %A Kim,Hee Young %A Lee,Soo-Kyung %A Kim,Sin Gon %+ Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, 73 Goryeodae-ro, Seongbuk-gu, Seoul, 02841, Republic of Korea, 82 2 920 5890, k50367@korea.ac.kr %K digital health intervention %K wearable activity tracker %K physical activity intervention %K Fitbit %K North Korean refugees %K metabolic risk management %K step counts %D 2023 %7 19.7.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Effective health interventions for North Korean refugees vulnerable to metabolic disorders are currently unelucidated. Objective: This study aimed to evaluate the effects of digital health interventions in North Korean refugees using a wearable activity tracker (Fitbit device). Methods: We conducted a prospective, randomized, open-label study on North Korean refugees aged 19-59 years between June 2020 and October 2021 with a 12-week follow-up period. The participants were randomly assigned to either an intervention group or a control group in a 1:1 ratio. The intervention group received individualized health counseling based on Fitbit data every 4 weeks, whereas the control group wore the Fitbit device but did not receive individualized counseling. The primary and secondary outcomes were the change in the mean daily step count and changes in the metabolic parameters, respectively. Results: The trial was completed by 52 North Korean refugees, of whom 27 and 25 were in the intervention and control groups, respectively. The mean age was 43 (SD 10) years, and 41 (78.8%) participants were women. Most participants (44/52, 95.7%) had a low socioeconomic status. After the intervention, the daily step count in the intervention group increased, whereas that in the control group decreased. However, there were no significant differences between the 2 groups (+83 and –521 steps in the intervention and control groups, respectively; P=.500). The effects of the intervention were more prominent in the participants with a lower-than-average daily step count at baseline (<11,667 steps/day). After the 12-week study period, 85.7% (12/14) and 46.7% (7/15) of the participants in the intervention and control groups, respectively, had an increased daily step count (P=.05). The intervention prevented the worsening of the metabolic parameters, including BMI, waist circumference, fasting blood glucose level, and glycated hemoglobin level, during the study period. Conclusions: The wearable device–based physical activity intervention did not significantly increase the average daily step count in the North Korean refugees in this study. However, the intervention was effective among the North Korean refugees with a lower-than-average daily step count; therefore, a large-scale, long-term study of this intervention type in an underserved population is warranted. Trial Registration: Clinical Research Information Service KCT0007999; https://cris.nih.go.kr/cris/search/detailSearch.do/23622 %M 37467013 %R 10.2196/45975 %U https://www.jmir.org/2023/1/e45975 %U https://doi.org/10.2196/45975 %U http://www.ncbi.nlm.nih.gov/pubmed/37467013 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e41092 %T Video-Based Educational Interventions for Patients With Chronic Illnesses: Systematic Review %A Deshpande,Nikita %A Wu,Meng %A Kelly,Colleen %A Woodrick,Nicole %A Werner,Debra A %A Volerman,Anna %A Press,Valerie G %+ Section of General Internal Medicine, Department of Medicine, University of Chicago, MC 2007, 5841 S Maryland Ave, Chicago, IL, 60637, United States, 1 (773) 702 5170, vpress@bsd.uchicago.edu %K chronic disease %K patient education %K video-based interventions %K video education %K technology %K health literacy %K self-management %D 2023 %7 19.7.2023 %9 Review %J J Med Internet Res %G English %X Background: With rising time constraints, health care professionals increasingly depend on technology to provide health advice and teach patients how to manage chronic disease. The effectiveness of video-based tools in improving knowledge, health behaviors, disease severity, and health care use for patients with major chronic illnesses is not well understood. Objective: The aim of this study was to assess the current literature regarding the efficacy of video-based educational tools for patients in improving process and outcome measures across several chronic illnesses. Methods: A systematic review was conducted using CINAHL and PubMed with predefined search terms. The search included studies published through October 2021. The eligible studies were intervention studies of video-based self-management patient education for an adult patient population with the following chronic health conditions: asthma, chronic kidney disease, chronic obstructive pulmonary disease, chronic pain syndromes, diabetes, heart failure, HIV infection, hypertension, inflammatory bowel disease, and rheumatologic disorders. The eligible papers underwent full extraction of study characteristics, study design, sample demographics, and results. Bias was assessed with the Cochrane risk-of-bias tools. Summary statistics were synthesized in Stata SE (StataCorp LLC). Data reporting was conducted per the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) checklist. Results: Of the 112 studies fully extracted, 59 (52.7%) were deemed eligible for inclusion in this review. The majority of the included papers were superiority randomized controlled trials (RCTs; 39/59, 66%), with fewer pre-post studies (13/59, 22%) and noninferiority RCTs (7/59, 12%). The most represented conditions of interest were obstructive lung disease (18/59, 31%), diabetes (11/59, 19%), and heart failure (9/59, 15%). The plurality (28/59, 47%) of video-based interventions only occurred once and occurred alongside adjunct interventions that included printed materials, in-person counseling, and interactive modules. The most frequently studied outcomes were disease severity, health behavior, and patient knowledge. Video-based tools were the most effective in improving patient knowledge (30/40, 75%). Approximately half reported health behavior (21/38, 56%) and patient self-efficacy (12/23, 52%) outcomes were improved by video-based tools, and a minority of health care use (11/28, 39%) and disease severity (23/69, 33%) outcomes were improved by video-based tools. In total, 48% (22/46) of the superiority and noninferiority RCTs and 54% (7/13) of the pre-post trials had moderate or high risk of bias. Conclusions: There is robust evidence that video-based tools can improve patient knowledge across several chronic illnesses. These tools less consistently improve disease severity and health care use outcomes. Additional study is needed to identify features that maximize the efficacy of video-based interventions for patients across the spectrum of digital competencies to ensure optimized and equitable patient education and outcomes. %M 37467015 %R 10.2196/41092 %U https://www.jmir.org/2023/1/e41092 %U https://doi.org/10.2196/41092 %U http://www.ncbi.nlm.nih.gov/pubmed/37467015 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e44365 %T Effects of Induced Mindfulness at Night on Repetitive Negative Thinking: Ecological Momentary Assessment Study %A Sommerhoff,Amanda %A Ehring,Thomas %A Takano,Keisuke %+ Human Informatics and Interaction Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), 1-1-1 Higashi, Tsukuba, Ibaraki, 305-8566, Japan, 81 29 849 1456, keisuke.takano@aist.go.jp %K mindfulness %K repetitive negative thinking %K stress %K daily life %K ecological momentary assessment %K mobile phone %D 2023 %7 19.7.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Repetitive negative thinking (RNT) is a cognitive risk factor for various disorders. Although brief mindfulness-based interventions (MBIs; lasting 20-30 minutes or shorter) are effective tools to reduce RNT, the effect of a minimal (5-minute) MBI remains largely unknown. Objective: We investigated the acute changes in RNT induced by a 10-day minimal MBI (body scan before sleeping) using an ecological momentary assessment (EMA) administered during the MBI training phase. In addition, we examined longer-term effects on the postintervention and 2-month follow-up assessments for questionnaire-based RNT and psychological distress. Methods: A total of 68 participants (community sample, aged 18-55 years; n=58, 85% women) were randomly allocated to either the intervention group (n=35, 51%) or the no-training control group (n=33, 49%). Both groups completed a 10-day EMA phase of RNT, during which only the intervention group performed a daily 5-minute body scan before sleeping. Results: The intervention group showed a significantly larger reduction in questionnaire-based RNT than the control group at the follow-up assessment (for growth-curve modeling analysis [GMA], dGMA=−0.91; P<.001), but this effect was not observed during the EMA phase or at the postintervention assessment. Furthermore, the intervention group showed significantly larger decreases in stress both at the postintervention (dGMA=−0.78; P<.001) and follow-up (dGMA=−0.60; P<.001) assessments than the control group. We found no intervention effects on depressive and anxiety symptoms. Conclusions: A 5-minute body scan before sleeping reduces RNT and stress when continued for at least 10 days; however, the results suggest that this effect only appears with some time lag because no acute changes during and immediately after the intervention emerged for RNT. %M 37467038 %R 10.2196/44365 %U https://mental.jmir.org/2023/1/e44365 %U https://doi.org/10.2196/44365 %U http://www.ncbi.nlm.nih.gov/pubmed/37467038 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45984 %T Scope, Characteristics, Behavior Change Techniques, and Quality of Conversational Agents for Mental Health and Well-Being: Systematic Assessment of Apps %A Lin,Xiaowen %A Martinengo,Laura %A Jabir,Ahmad Ishqi %A Ho,Andy Hau Yan %A Car,Josip %A Atun,Rifat %A Tudor Car,Lorainne %+ Lee Kong Chian School of Medicine, Nanyang Technological University Singapore, 11 Mandalay Rd, Singapore, Singapore, 308232, Singapore, 65 69041258, lorainne.tudor.car@ntu.edu.sg %K conversational agent %K chatbot %K mental health %K mobile health %K mHealth %K behavior change %K apps %K Mobile Application Rating Scale %K MARS %K mobile phone %D 2023 %7 18.7.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Mental disorders cause substantial health-related burden worldwide. Mobile health interventions are increasingly being used to promote mental health and well-being, as they could improve access to treatment and reduce associated costs. Behavior change is an important feature of interventions aimed at improving mental health and well-being. There is a need to discern the active components that can promote behavior change in such interventions and ultimately improve users’ mental health. Objective: This study systematically identified mental health conversational agents (CAs) currently available in app stores and assessed the behavior change techniques (BCTs) used. We further described their main features, technical aspects, and quality in terms of engagement, functionality, esthetics, and information using the Mobile Application Rating Scale. Methods: The search, selection, and assessment of apps were adapted from a systematic review methodology and included a search, 2 rounds of selection, and an evaluation following predefined criteria. We conducted a systematic app search of Apple’s App Store and Google Play using 42matters. Apps with CAs in English that uploaded or updated from January 2020 and provided interventions aimed at improving mental health and well-being and the assessment or management of mental disorders were tested by at least 2 reviewers. The BCT taxonomy v1, a comprehensive list of 93 BCTs, was used to identify the specific behavior change components in CAs. Results: We found 18 app-based mental health CAs. Most CAs had <1000 user ratings on both app stores (12/18, 67%) and targeted several conditions such as stress, anxiety, and depression (13/18, 72%). All CAs addressed >1 mental disorder. Most CAs (14/18, 78%) used cognitive behavioral therapy (CBT). Half (9/18, 50%) of the CAs identified were rule based (ie, only offered predetermined answers) and the other half (9/18, 50%) were artificial intelligence enhanced (ie, included open-ended questions). CAs used 48 different BCTs and included on average 15 (SD 8.77; range 4-30) BCTs. The most common BCTs were 3.3 “Social support (emotional),” 4.1 “Instructions for how to perform a behavior,” 11.2 “Reduce negative emotions,” and 6.1 “Demonstration of the behavior.” One-third (5/14, 36%) of the CAs claiming to be CBT based did not include core CBT concepts. Conclusions: Mental health CAs mostly targeted various mental health issues such as stress, anxiety, and depression, reflecting a broad intervention focus. The most common BCTs identified serve to promote the self-management of mental disorders with few therapeutic elements. CA developers should consider the quality of information, user confidentiality, access, and emergency management when designing mental health CAs. Future research should assess the role of artificial intelligence in promoting behavior change within CAs and determine the choice of BCTs in evidence-based psychotherapies to enable systematic, consistent, and transparent development and evaluation of effective digital mental health interventions. %M 37463036 %R 10.2196/45984 %U https://www.jmir.org/2023/1/e45984 %U https://doi.org/10.2196/45984 %U http://www.ncbi.nlm.nih.gov/pubmed/37463036 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e45057 %T Patterns and Predictors of Engagement With Digital Self-Monitoring During the Maintenance Phase of a Behavioral Weight Loss Program: Quantitative Study %A Crane,Nicole %A Hagerman,Charlotte %A Horgan,Olivia %A Butryn,Meghan %+ Center for Weight, Eating, and Lifestyle Science, Department of Psychological and Brain Sciences, Drexel University, 3141 Chestnut Street, Stratton Hall, Philadelphia, PA, 19104, United States, 1 724 740 8648, nvt24@drexel.edu %K weight loss %K digital technology %K diet %K exercise %K behavior change %K mobile phone %D 2023 %7 18.7.2023 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Long-term self-monitoring (SM) of weight, diet, and exercise is commonly recommended by behavioral weight loss (BWL) treatments. However, sustained SM engagement is notoriously challenging; therefore, more must be learned about patterns of engagement with digital SM tools during weight loss maintenance (WLM). In addition, insight into characteristics that may influence SM engagement could inform tailored approaches for participants at risk for poor adherence. Objective: This study explored patterns of digital SM of weight, diet, and exercise during WLM (aim 1) and examined timing, patterns, and rates of disengagement and reengagement (aim 2). This study also assessed relationships between individual-level factors (weight-related information avoidance and weight bias internalization) and SM engagement (aim 3). Methods: Participants were 72 adults enrolled in a BWL program consisting of a 3-month period of weekly treatment designed to induce weight loss (phase I), followed by a 9-month period of less frequent contact to promote WLM (phase II). Participants were prescribed daily digital SM of weight, diet, and exercise. At baseline, self-report measures assessed weight-related information avoidance and weight bias internalization. SM adherence was objectively measured with the days per month that participants tracked weight, diet, and exercise. Repeated-measures ANOVA examined differences in adherence across SM targets. Multilevel modeling examined changes in adherence across phase II. Relationships between individual-level variables and SM adherence were assessed with Pearson correlations, 2-tailed independent samples t tests, and multilevel modeling. Results: During WLM, consistently high rates of SM (≥50% of the days in each month) were observed for 61% (44/72) of the participants for exercise, 40% (29/72) of the participants for weight, and 21% (15/72) of the participants for diet. Adherence for SM of exercise was higher than that for weight or diet (P<.001). Adherence decreased over time for all SM targets throughout phase II (P<.001), but SM of exercise dropped off later in WLM (mean 10.07, SD 2.83 months) than SM of weight (mean 7.92, SD 3.23 months) or diet (mean 7.58, SD 2.92 months; P<.001). Among participants with a period of low SM adherence (ie, <50% of the days in a month), only 33% (17/51 for weight, 19/57 for diet) to 46% (13/28 for exercise) subsequently had ≥1 months with high adherence. High weight-related information avoidance predicted a faster rate of decrease in dietary SM (P<.001). Participants with high weight bias internalization had the highest rates of weight SM (P=.03). Conclusions: Participants in BWL programs have low adherence to the recommendation to sustain daily SM during WLM, particularly for SM of diet and weight. Weight-related information avoidance and weight bias internalization may be relevant indicators for SM engagement. Interventions may benefit from innovative strategies that target participants at key moments of risk for disengagement. %M 37463017 %R 10.2196/45057 %U https://mhealth.jmir.org/2023/1/e45057 %U https://doi.org/10.2196/45057 %U http://www.ncbi.nlm.nih.gov/pubmed/37463017 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46298 %T Association Between Daily Internet Use and Incidence of Chronic Diseases Among Older Adults: Prospective Cohort Study %A Li,Peiyi %A Zhang,Chenyang %A Gao,Shuanliang %A Zhang,Yanbo %A Liang,Xiaolong %A Wang,Chengdi %A Zhu,Tao %A Li,Weimin %+ Department of Respiratory and Critical Care Medicine, West China Hospital, Sichuan University, Guo Xue Xiang 37, Sichuan, Chengdu, 610041, China, 86 028 85423998, weimi003@scu.edu.cn %K daily internet use %K chronic disease %K disease prevention %K middle-aged and older adult %K usage %K internet use %K technology use %K chronic illness %K association %K incidence %K middle age %K older adult %K gerontology %K geriatric %K aging %K elder %K national survey %D 2023 %7 17.7.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic disease incidence among the elderly is increasing, which is correlated with the acceleration of population aging. Evolving internet technologies may help prevent and provide interventions for chronic diseases in an accelerating aging process. However, the impact of daily internet use on the incidence of chronic diseases is not well understood. Objective: This study aims to investigate whether daily internet use by middle-aged and older adults may inhibit or promote the occurrence of chronic diseases. Methods: We included participants from the China Health and Retirement Longitudinal Study (CHARLS), a longitudinal survey of Chinese residents aged ≥45 years. We assessed 8-year data from wave 1 (June 2011-March 2012) to wave 4 (July-September 2018) in CHARLS. Data from wave 4 were used for a cross-sectional study, and data from all 4 waves were used for a longitudinal study. Self-reported data were used to track variables, including internet use, use frequency, and the incidence of different chronic diseases. Cox proportional hazards modeling was applied in the longitudinal study to examine the relationship between daily internet use and chronic diseases among middle-aged and older adults, while adjusting for sociodemographic characteristics and health behaviors. In addition, longitudinal data were used to analyze internet usage trends, and cross-sectional data were used to analyze the factors influencing internet use. Results: Among the 20,113 participants included in the longitudinal analyses, internet use increased significantly, from 2% to 12.3%, between 2011 and 2018. The adjusted model found statistically significant relationships between daily internet use and a lower incidence of the following chronic diseases: hypertension (hazard ratio [HR] 0.78, 95% CI 0.65-0.95, P=.01), chronic lung disease (HR 0.74, 95% CI 0.57-0.97, P=.03), stroke (HR 0.69, 95% CI 0.50-0.94, P=.02), digestive disease (HR 0.73, 95% CI 0.58-0.91, P=.005), memory-related disorders (HR 0.58, 95% CI 0.37-0.91, P=.02), arthritis or rheumatism (HR 0.60, 95% CI 0.48-0.76, P<.001), asthma (HR 0.52, 95% CI 0.33-0.84, P=.007), depression (HR 0.80, 95% CI 0.71-0.89, P<.001), and vision impairment (HR 0.83, 95% CI 0.74-0.93, P=.004). Moreover, our study also showed that with increasing frequency of internet use, the risk of some chronic diseases decreases. Conclusions: This study found that middle-aged and older adults who use the internet have a reduced risk of developing chronic diseases versus those who do not use the internet. The increasing prevalence of daily internet use among middle-aged and older adults may stimulate contemplation of the potential role of internet platforms in future research on chronic disease prevention. %M 37459155 %R 10.2196/46298 %U https://www.jmir.org/2023/1/e46298 %U https://doi.org/10.2196/46298 %U http://www.ncbi.nlm.nih.gov/pubmed/37459155 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e42377 %T Examining Predictors of Depression and Anxiety Symptom Change in Cognitive Behavioral Immersion: Observational Study %A Ezawa,Iony D %A Hollon,Steven D %A Robinson,Noah %+ Department of Psychology, University of Southern California, 3620 McClintock Ave, Los Angeles, CA, 90089, United States, 1 213 740 2203, ezawa@usc.edu %K Cognitive Behavioral Immersion %K virtual reality %K metaverse %K alliance %K social support %K cognitive behavioral %K depression %K anxiety %K mood %K mental health %K mobile phone %D 2023 %7 14.7.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Depressive and anxiety disorders are the most common mental disorders, and there is a critical need for effective, affordable, and accessible interventions. Cognitive Behavioral Immersion (CBI) is a novel group-based cognitive behavioral skills training program delivered by lay coaches in the metaverse that can be accessed through various modalities including virtual reality (VR) head-mounted displays or flat-screen devices. Combining its ability to offer empirically supported therapy skills in a digital setting that can still facilitate interpersonal variables (eg, working alliance and sense of social support) with the aid of lay coaches, CBI has the potential to help fill this critical need. Objective: This study had 2 primary aims. First, we aimed to examine changes in depression and anxiety symptoms in a sample of individuals who participated in CBI. Second, we aimed to examine 2 interpersonal process variables (working alliance and web-based social support) as predictors of symptom changes. We predicted CBI participants would experience depression and anxiety symptom improvements and that such improvements would be associated with an increase in both interpersonal process variables. Methods: The study sample consists of 127 participants who endorsed clinical levels of depression or anxiety symptoms during their first CBI session and attended at least 2 sessions. Participants were asked to complete self-report measures of depression symptoms, anxiety symptoms, alliance, and web-based social support throughout their participation in CBI. Results: Repeated measures ANOVAs determined that depression and anxiety symptom scores differed significantly across sessions (Ps<.01). We also found participants’ web-based social support predicted improvement in depression symptoms (P=.01), but neither the alliance nor web-based social support predicted change in anxiety symptoms (Ps>.05). We also observed a significant difference in anxiety symptoms between participants who used a VR head-mounted display to access CBI and those who did not, such that participants who used VR head-mounted displays endorsed lower anxiety symptoms than those who did not at nearly every session (P=.04). Conclusions: Participation in CBI is associated with both depression and anxiety symptom improvement. Web-based social support may play an important role in fostering changes in depression symptoms. Future studies are encouraged to continue examining the process of change in CBI with special attention paid to methods that can elucidate causal mechanisms of change. %M 37450322 %R 10.2196/42377 %U https://mental.jmir.org/2023/1/e42377 %U https://doi.org/10.2196/42377 %U http://www.ncbi.nlm.nih.gov/pubmed/37450322 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45207 %T The Effectiveness of Digital Apps Providing Personalized Exercise Videos: Systematic Review With Meta-Analysis %A Davergne,Thomas %A Meidinger,Philippe %A Dechartres,Agnès %A Gossec,Laure %+ Physical Medicine and Rehabilitation Department, Assistance Publique – Hôpitaux de Paris Lariboisière-Fernand-Widal, Université Paris Cité, Institut national de la santé et de la recherche médicale, Biologie de l'os et du cartilage, 2 Rue Ambroise Paré, Paris, 75010, France, 33 675976781, thomas.davergne@gmail.com %K app %K exercise program %K telerehabilitation %K rehabilitation %K disability %K disabilities %K digital care %K web-based %K exercise %K physical activity %K fitness %K health app %K HRQoL %K QoL %K quality of life %K physical therapy %K physiotherapy %K systematic review %K review method %K adherence %K meta-analysis %K meta-analyses %D 2023 %7 13.7.2023 %9 Review %J J Med Internet Res %G English %X Background: Among available digital apps, those providing personalized video exercises may be helpful for individuals undergoing functional rehabilitation. Objective: We aimed to assess the effectiveness of apps providing personalized video exercises to support rehabilitation for people with short- and long-term disabling conditions, on functional capacity, confidence in exercise performance, health care consumption, health-related quality of life, adherence, and adverse events. Methods: In this systematic review, we searched MEDLINE, CENTRAL, and Embase databases up to March 2022. All randomized controlled trials evaluating the effect of apps providing personalized video exercises to support rehabilitation for any condition requiring physical rehabilitation were included. Selection, extraction, and risk of bias assessment were performed by 2 independent reviewers. The primary outcome was functional capacity at the end of the intervention. The secondary outcomes included confidence in exercise performance, care consumption, health-related quality of life, adherence, and adverse events. A meta-analysis was performed where possible; the magnitude of the effect was assessed with the standardized mean difference (SMD). Results: From 1641 identified references, 10 papers (n=1050 participants, 93% adults) were included: 7 papers (n=906 participants) concerned musculoskeletal disorders and 3 (n=144 participants) concerned neurological disorders. Two (n=332 participants) were employee based. The apps were mostly commercial (7/10); the videos were mostly elaborated on by a physiotherapist (8/10). The duration of app use was 3-48 weeks. All included studies had a high overall risk of bias. Low-quality evidence suggested that the use of apps providing personalized video exercises led to a significant small to moderate improvement in physical function (SMD 0.35, 95% CI 0.19-0.51; Phet=.86; I2=0%) and confidence in exercise performance (SMD 0.67; 95% CI 0.37-0.96; Phet=.22; I2=33%). Because of the very low quality of the evidence, the effects on quality of life and exercise adherence were uncertain. Apps did not influence the rate of adverse events. Conclusions: Apps providing personalized video exercises to support exercise performance significantly improved physical function and confidence in exercise performance. However, the level of evidence was low; more robust studies are needed to confirm these results. Trial Registration: PROSPERO CRD42022323670; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=323670 %M 37440300 %R 10.2196/45207 %U https://www.jmir.org/2023/1/e45207 %U https://doi.org/10.2196/45207 %U http://www.ncbi.nlm.nih.gov/pubmed/37440300 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45183 %T Smartphone Apps for Smoking Cessation: Systematic Framework for App Review and Analysis %A Bold,Krysten W %A Garrison,Kathleen A %A DeLucia,Angela %A Horvath,Mark %A Nguyen,Milton %A Camacho,Erica %A Torous,John %+ Department of Psychiatry, Yale School of Medicine, 34 Park Street CMHC, New Haven, CT, 06519, United States, 1 203 974 7603, krysten.bold@yale.edu %K addict %K app review %K application %K apps %K cessation %K cigarette %K digital health %K mhealth %K mobile app %K mobile health %K quit %K review of app %K smartphone app %K smoker %K smoking cessation %K smoking %K tobacco %D 2023 %7 13.7.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Cigarette smoking is a leading cause of preventable death, and identifying novel treatment approaches to promote smoking cessation is critical for improving public health. With the rise of digital health and mobile apps, these tools offer potential opportunities to address smoking cessation, yet the functionality of these apps and whether they offer scientifically based support for smoking cessation are unknown. Objective: The goal of this research was to use the American Psychiatric Association app evaluation model to evaluate the top-returned apps from Android and Apple app store platforms related to smoking cessation and investigate the common app features available for end users. Methods: We conducted a search of both Android and iOS app stores in July 2021 for apps related to the keywords “smoking,” “tobacco,” “smoke,” and “cigarette” to evaluate apps for smoking cessation. Apps were screened for relevance, and trained raters identified and analyzed features, including accessibility (ie, cost), privacy, clinical foundation, and features of the apps, using a systematic framework of 105 objective questions from the American Psychiatric Association app evaluation model. All app rating data were deposited in mindapps, a publicly accessible database that is continuously updated every 6 months given the dynamic nature of apps available in the marketplace. We characterized apps available in July 2021 and November 2022. Results: We initially identified 389 apps, excluded 161 due to irrelevance and nonfunctioning, and rated 228, including 152 available for Android platforms and 120 available for iOS platforms. Some of the top-returned apps (71/228, 31%) in 2021 were no longer functioning in 2022. Our analysis of rated apps revealed limitations in accessibility and features. While most apps (179/228, 78%) were free to download, over half had costs associated with in-app purchases or full use. Less than 65% (149/228) had a privacy policy addressing the data collected in the app. In terms of intervention features, more than 56% (128/228) of apps allowed the user to set and check in on goals, and more than 46% (106/228) of them provided psychoeducation, although few apps provided evidence-based support for smoking cessation, such as peer support or skill training, including mindfulness and deep breathing, and even fewer provided evidence-based interventions, such as acceptance and commitment therapy or cognitive behavioral therapy. Only 12 apps in 2021 and 11 in 2022 had published studies supporting the feasibility or efficacy for smoking cessation. Conclusions: Numerous smoking cessation apps were identified, but analysis revealed limitations, including high rates of irrelevant and nonfunctioning apps, high rates of turnover, and few apps providing evidence-based support for smoking cessation. Thus, it may be challenging for consumers to identify relevant, evidence-based apps to support smoking cessation in the app store, and a comprehensive evaluation system of mental health apps is critically important. %M 37440305 %R 10.2196/45183 %U https://www.jmir.org/2023/1/e45183 %U https://doi.org/10.2196/45183 %U http://www.ncbi.nlm.nih.gov/pubmed/37440305 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43504 %T The Building Healthy Eating and Self-Esteem Together for University Students Mobile App to Treat Eating Disorders: User-Centered Research Design and Feasibility Study %A Forbush,Kelsie T %A Christensen Pacella,Kara A %A Thomeczek,Marianna L %A Gould,Sara R %A A N Chapa,Danielle %A Richson,Brianne N %A Perko,Victoria L %A Ayres,Joseph %A Chen,Yiyang %A Negi,Sonakshi %+ Department of Psychology, University of Kansas, Dole Human Development Center, 1000 Sunnyside Avenue, Lawrence, KS, 66049, United States, 1 7858646525, dr.forbush@ku.edu %K Building Healthy Eating and Self-Esteem Together for University Students %K BEST-U %K eating disorders %K EDs %K college %K university %K students %K cognitive behavioral therapy %K dialectical behavioral therapy %K mobile health %K mHealth %K mental health %K guided self-help %K therapy %K app %K treatment %K design %K usability %K testing %K development %K development %K acceptability %K cognitive %K mobile phone %D 2023 %7 12.7.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: University students are an at-risk group for the development of eating disorders (EDs); however, many college campuses lack sufficient resources to provide ED specialty care. Students report unique reasons for not seeking ED treatment, including the desire to solve the problem on their own (eg, seeking help from friends, self-medicating, or waiting to see if their problems improve), inability to afford treatment, lack of time to participate in the treatment, fear of seeing their primary care physician, and lack of recognition of their issues as an ED. Mobile health (mHealth) apps may be a cost-effective, helpful adjunctive tool to overcome personal and systemic barriers and encourage help seeking. Objective: This paper describes the development, usability, and acceptability of the Building Healthy Eating and Self-Esteem Together for University Students (BEST-U) mHealth smartphone app, which is designed to fill critical gaps in access to ED treatment on college campuses. Methods: We undertook a 4-phase iterative development process that focused on user-centered design. The 4 phases included needs assessment based on literature reviews, prototype development and initial evaluation in a pilot trial, redesign, and further pilot-testing to assess the usability and acceptability of the final version of the mHealth app. Acceptability and user satisfaction were assessed using an ad hoc survey that ranged from 1 (strongly disagree) to 7 (strongly agree). Results: Our needs assessment identified a lack of accessible and affordable treatments for university students. To help meet this need, the BEST-U prototype was designed as an 11-week program that provided interactive, weekly modules that focused on second- and third-wave cognitive behavioral skills. The modules focused on topics such as psychoeducation, reducing thought distortions and body checking, improving body image, interpersonal effectiveness, and behavior chain analysis. The content included interactive quizzes, short answer questions, daily and weekly logs, and surveys completed in the app. BEST-U was paired with brief 25-30 minutes of weekly telehealth coaching sessions provided by a licensed provider or supervised trainee. Pilot-testing revealed minor issues with one module of the app content, which some participants viewed as having low relevance to their experience and therapist concerns about the organization of the app content. These issues were addressed through the removal, addition, and reorganization of BEST-U modules, with the help of therapists-in-training across 2 workshops. The revised version of the BEST-U app had a grand mean acceptability rating of 5.73 out of 7. The participants completed 90.1% (694/770) of the BEST-U modules, indicating high compliance. Conclusions: BEST-U is a new, acceptable, and user-friendly mHealth app to help therapists deliver brief, evidence-based cognitive behavioral interventions. Owing to its acceptability and user-friendly nature, BEST-U has high user compliance and holds promise for future implementation and dissemination in university mental health settings. %M 37436790 %R 10.2196/43504 %U https://formative.jmir.org/2023/1/e43504 %U https://doi.org/10.2196/43504 %U http://www.ncbi.nlm.nih.gov/pubmed/37436790 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45607 %T Author’s Reply to: Environmental Influence and Recruitment Bias in Studies on Internet Addiction. Comment on “Addiction Symptom Network of Young Internet Users: Network Analysis” %A Zheng,Hui %+ Shanghai Key Laboratory of Psychotic Disorders, Brain Health Institute, National Center for Mental Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 South Wanping Road, Xuhui District, Shanghai, 200030, China, 86 18267908575, zh.dmtr@gmail.com %K internet addiction %K Internet Addiction Test %K network analysis %K adolescents %D 2023 %7 11.7.2023 %9 Letter to the Editor %J J Med Internet Res %G English %X %M 37432733 %R 10.2196/45607 %U https://www.jmir.org/2023/1/e45607 %U https://doi.org/10.2196/45607 %U http://www.ncbi.nlm.nih.gov/pubmed/37432733 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44438 %T Environmental Influence and Recruitment Bias in Studies on Internet Addiction. Comment on “Addiction Symptom Network of Young Internet Users: Network Analysis” %A Huang,Ting Yun %A Liaw,Yung-Po %+ School of Medicine, Chung Shan Medical University, No 110, Section 1, Jianguo N Rd, South District, Taichung City, 40201, Taiwan, 886 0424730022 ext 11838, liawyp@csmu.edu.tw %K internet addiction %K Internet Addiction Test %K network analysis %K adolescents %D 2023 %7 11.7.2023 %9 Letter to the Editor %J J Med Internet Res %G English %X %M 37432717 %R 10.2196/44438 %U https://www.jmir.org/2023/1/e44438 %U https://doi.org/10.2196/44438 %U http://www.ncbi.nlm.nih.gov/pubmed/37432717 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47656 %T Does an Internet-Based Emotion Regulation Intervention Provide Added Value for Acute Psychiatric Inpatient Care? Protocol for a Randomized Controlled Pilot Trial %A Bielinski,Laura Luisa %A Wälchli,Gwendolyn %A Nissen,Christoph %A Berger,Thomas %A Moggi,Franz %+ Department of Clinical Psychology and Psychotherapy, University of Bern, Fabrikstrasse 8, Bern, 3012, Switzerland, 41 794457768, laura.bielinski@unibe.ch %K blended treatment %K inpatient %K emotion regulation %K internet intervention %K acute psychiatric setting %K randomized controlled pilot trial %K randomized controlled trial %K RCT %K transdiagnostic %K feasibility %K emotion %K mental health %K psychiatric %K psychiatry %K randomized %K internet based %K digital health %D 2023 %7 11.7.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: There is a lack of studies on internet-based interventions in inpatient settings. This is especially true for studies of internet-based interventions in acute psychiatric inpatient care. Internet-based interventions in this specific setting may provide benefits such as patient empowerment and overall improved treatment outcomes. However, there may also be specific barriers to their implementation that are unique due to the complexity of acute psychiatric inpatient care. Objective: The aim of this study is to examine the feasibility and preliminary evidence for effectiveness of a web-based emotion regulation intervention provided as an add-on to acute psychiatric inpatient care. Methods: The goal is to randomly allocate 60 patients with a range of different diagnoses in a 1:1 ratio to either treatment as usual (TAU), which consists of acute psychiatric inpatient treatment, or to the intervention group, which will receive TAU plus access to a web-based intervention that focuses on reduction of emotion regulation difficulties and improvement of emotion regulation skills. The primary outcome is symptom severity, assessed with the short form of the Brief Symptom Inventory at baseline, after 4 weeks, after 8 weeks, and at hospital discharge. Secondary outcomes include 2 emotion regulation parameters, intervention use, usability, patient satisfaction, and reasons for patient loss to follow-up. Results: Participant recruitment started in August 2021 and as of March 2023 was ongoing. First publication of study results is expected in 2024. Conclusions: This study protocol describes a study that intends to examine a web-based emotion regulation intervention in acute psychiatric inpatient care. The study will provide information on the feasibility of the intervention and possible effects on symptom severity and emotion regulation. The results will provide new insights on blended treatment, in this case the combination of a web-based intervention and face-to-face psychiatric treatment, in an understudied patient group and setting. Trial Registration: ClinicalTrials.gov NCT04990674; https://clinicaltrials.gov/ct2/show/NCT04990674 International Registered Report Identifier (IRRID): DERR1-10.2196/47656 %M 37432724 %R 10.2196/47656 %U https://www.researchprotocols.org/2023/1/e47656 %U https://doi.org/10.2196/47656 %U http://www.ncbi.nlm.nih.gov/pubmed/37432724 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46781 %T Effects of an Artificial Intelligence Platform for Behavioral Interventions on Depression and Anxiety Symptoms: Randomized Clinical Trial %A Sadeh-Sharvit,Shiri %A Camp,T Del %A Horton,Sarah E %A Hefner,Jacob D %A Berry,Jennifer M %A Grossman,Eyal %A Hollon,Steven D %+ Eleos Health, 260 Charles St, Waltham, MA, 02453, United States, 1 5109848132, ssharvit@paloaltou.edu %K augmentation %K anxiety %K artificial intelligence %K cognitive-behavioral therapy %K community-based center %K depression %K evidence-based practices %K health force burnout %K depressive %D 2023 %7 10.7.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: The need for scalable delivery of mental health care services that are efficient and effective is now a major public health priority. Artificial intelligence (AI) tools have the potential to improve behavioral health care services by helping clinicians collect objective data on patients’ progress, streamline their workflow, and automate administrative tasks. Objective: The aim of this study was to determine the feasibility, acceptability, and preliminary efficacy of an AI platform for behavioral health in facilitating better clinical outcomes for patients receiving outpatient therapy. Methods: The study was conducted at a community-based clinic in the United States. Participants were 47 adults referred for outpatient, individual cognitive behavioral therapy for a main diagnosis of a depressive or anxiety disorder. The platform provided by Eleos Health was compared to a treatment-as-usual (TAU) approach during the first 2 months of therapy. This AI platform summarizes and transcribes the therapy session, provides feedback to therapists on the use of evidence-based practices, and integrates these data with routine standardized questionnaires completed by patients. The information is also used to draft the session’s progress note. Patients were randomized to receive either therapy provided with the support of an AI platform developed by Eleos Health or TAU at the same clinic. Data analysis was carried out based on an intention-to-treat approach from December 2022 to January 2023. The primary outcomes included the feasibility and acceptability of the AI platform. Secondary outcomes included changes in depression (Patient Health Questionnaire-9) and anxiety (Generalized Anxiety Disorder-7) scores as well as treatment attendance, satisfaction, and perceived helpfulness. Results: A total of 72 patients were approached, of whom 47 (67%) agreed to participate. Participants were adults (34/47, 72% women and 13/47, 28% men; mean age 30.64, SD 11.02 years), with 23 randomized to the AI platform group, and 24 to TAU. Participants in the AI group attended, on average, 67% (mean 5.24, SD 2.31) more sessions compared to those in TAU (mean 3.14, SD 1.99). Depression and anxiety symptoms were reduced by 34% and 29% in the AI platform group versus 20% and 8% for TAU, respectively, with large effect sizes for the therapy delivered with the support of the AI platform. No group difference was found in 2-month treatment satisfaction and perceived helpfulness. Further, therapists using the AI platform submitted their progress notes, on average, 55 hours earlier than therapists in the TAU group (t=–0.73; P<.001). Conclusions: In this randomized controlled trial, therapy provided with the support of Eleos Health demonstrated superior depression and anxiety outcomes as well as patient retention, compared with TAU. These findings suggest that complementing the mental health services provided in community-based clinics with an AI platform specializing in behavioral treatment was more effective in reducing key symptoms than standard therapy. Trial Registration: ClinicalTrials.gov NCT05745103; https://classic.clinicaltrials.gov/ct2/show/NCT05745103 %M 37428547 %R 10.2196/46781 %U https://www.jmir.org/2023/1/e46781 %U https://doi.org/10.2196/46781 %U http://www.ncbi.nlm.nih.gov/pubmed/37428547 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45411 %T Efficacy of an Unguided, Digital Single-Session Intervention for Internalizing Symptoms in Web-Based Workers: Randomized Controlled Trial %A Lorenzo-Luaces,Lorenzo %A Howard,Jacqueline %+ Department of Psychological and Brain Sciences, Indiana University-Bloomington, 1101 E 10th St, Room 158, Bloomington, IN, 47401, United States, 1 7872222493, lolorenz@indiana.edu %K internet-based cognitive behavioral therapy %K iCBT %K depression %K transdiagnostic processes %K emotion regulation %D 2023 %7 7.7.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: The Common Elements Toolbox (COMET) is an unguided digital single-session intervention (SSI) based on principles of cognitive behavioral therapy and positive psychology. Although unguided digital SSIs have shown promise in the treatment of youth psychopathology, the data are more mixed regarding their efficacy in adults. Objective: This study aimed to investigate the efficacy of COMET-SSI versus a waiting list control in depression and other transdiagnostic mental health outcomes for Prolific participants with a history of psychopathology. Methods: We conducted an investigator-blinded, preregistered randomized controlled trial comparing COMET-SSI (n=409) with an 8-week waiting list control (n=419). Participants were recruited from the web-based workspace Prolific and assessed for depression, anxiety, work and social functioning, psychological well-being, and emotion regulation at baseline and at 2, 4, and 8 weeks after the intervention. The main outcomes were short-term (2 weeks) and long-term (8 weeks) changes in depression and anxiety. The secondary outcomes were the 8-week changes in work and social functioning, well-being, and emotion regulation. Analyses were conducted according to the intent-to-treat principle with imputation, without imputation, and using a per-protocol sample. In addition, we conducted sensitivity analyses to identify inattentive responders. Results: The sample comprised 61.9% (513/828) of women, with a mean age of 35.75 (SD 11.93) years. Most participants (732/828, 88.3%) met the criteria for screening for depression or anxiety using at least one validated screening scale. A review of the text data suggested that adherence to the COMET-SSI was near perfect, there were very few inattentive respondents, and satisfaction with the intervention was high. However, despite being powered to detect small effects, there were negligible differences between the conditions in the various outcomes at the various time points, even when focusing on subsets of individuals with more severe symptoms. Conclusions: Our results do not support the use of the COMET-SSI in adult Prolific participants. Future work should explore alternate ways of intervening with paid web-based participants, including matching individuals to SSIs they may be most responsive to. Trial Registration: ClinicalTrials.gov NCT05379881, https://clinicaltrials.gov/ct2/show/NCT05379881 %M 37418303 %R 10.2196/45411 %U https://www.jmir.org/2023/1/e45411 %U https://doi.org/10.2196/45411 %U http://www.ncbi.nlm.nih.gov/pubmed/37418303 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47930 %T Leveraging Electronic Health Record Technology and Team Care to Address Medication Adherence: Protocol for a Cluster Randomized Controlled Trial %A Blecker,Saul %A Schoenthaler,Antoinette %A Martinez,Tiffany Rose %A Belli,Hayley M %A Zhao,Yunan %A Wong,Christina %A Fitchett,Cassidy %A Bearnot,Harris R %A Mann,Devin %+ Department of Population Health, NYU Grossman School of Medicine, 227 E 30th Street, 6th Floor, New York, NY, 10016, United States, 1 6465012513, saul.blecker@nyulangone.org %K medication adherence %K hypertension %K clinical decision support %K proportion of days covered %K EHR %K electronic health record %K technology %K adherence %K primary care %D 2023 %7 7.7.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Low medication adherence is a common cause of high blood pressure but is often unrecognized in clinical practice. Electronic data linkages between electronic health records (EHRs) and pharmacies offer the opportunity to identify low medication adherence, which can be used for interventions at the point of care. We developed a multicomponent intervention that uses linked EHR and pharmacy data to automatically identify patients with elevated blood pressure and low medication adherence. The intervention then combines team-based care with EHR-based workflows to address medication nonadherence. Objective: This study aims to describe the design of the Leveraging EHR Technology and Team Care to Address Medication Adherence (TEAMLET) trial, which tests the effectiveness of a multicomponent intervention that leverages EHR-based data and team-based care on medication adherence among patients with hypertension. Methods: TEAMLET is a pragmatic, cluster randomized controlled trial in which 10 primary care practices will be randomized 1:1 to the multicomponent intervention or usual care. We will include all patients with hypertension and low medication adherence who are seen at enrolled practices. The primary outcome is medication adherence, as measured by the proportion of days covered, and the secondary outcome is clinic systolic blood pressure. We will also assess intervention implementation, including adoption, acceptability, fidelity, cost, and sustainability. Results: As of May 2023, we have randomized 10 primary care practices into the study, with 5 practices assigned to each arm of the trial. The enrollment for the study commenced on October 5, 2022, and the trial is currently ongoing. We anticipate patient recruitment to go through the fall of 2023 and the primary outcomes to be assessed in the fall of 2024. Conclusions: The TEAMLET trial will evaluate the effectiveness of a multicomponent intervention that leverages EHR-based data and team-based care on medication adherence. If successful, the intervention could offer a scalable approach to address inadequate blood pressure control among millions of patients with hypertension. Trial Registration: ClinicalTrials.gov NCT05349422; https://clinicaltrials.gov/ct2/show/NCT05349422 International Registered Report Identifier (IRRID): DERR1-10.2196/47930 %M 37418304 %R 10.2196/47930 %U https://www.researchprotocols.org/2023/1/e47930 %U https://doi.org/10.2196/47930 %U http://www.ncbi.nlm.nih.gov/pubmed/37418304 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46439 %T Benefits and Harms of Digital Health Interventions Promoting Physical Activity in People With Chronic Conditions: Systematic Review and Meta-Analysis %A Zangger,Graziella %A Bricca,Alessio %A Liaghat,Behnam %A Juhl,Carsten B %A Mortensen,Sofie Rath %A Andersen,Rune Martens %A Damsted,Camma %A Hamborg,Trine Grønbek %A Ried-Larsen,Mathias %A Tang,Lars Hermann %A Thygesen,Lau Caspar %A Skou,Søren T %+ The Research Unit PROgrez, Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospital, Fælledvej 2C, 1 sal, Slagelse, 4200, Denmark, 45 26142377, gzangger@health.sdu.dk %K digital health %K eHealth %K mobile health %K mHealth %K wearables %K physical activity %K physical function %K chronic conditions %K randomized controlled trials %K systematic review %K meta-analysis %D 2023 %7 6.7.2023 %9 Review %J J Med Internet Res %G English %X Background: Digital health interventions for managing chronic conditions have great potential. However, the benefits and harms are still unclear. Objective: This systematic review and meta-analysis aimed to investigate the benefits and harms of digital health interventions in promoting physical activity in people with chronic conditions. Methods: We searched the MEDLINE, Embase, CINAHL, and Cochrane Central Register of Controlled Trials databases from inception to October 2022. Eligible randomized controlled trials were included if they used a digital component in physical activity promotion in adults with ≥1 of the following conditions: depression or anxiety, ischemic heart disease or heart failure, chronic obstructive pulmonary disease, knee or hip osteoarthritis, hypertension, or type 2 diabetes. The primary outcomes were objectively measured physical activity and physical function (eg, walk or step tests). We used a random effects model (restricted maximum likelihood) for meta-analyses and meta-regression analyses to assess the impact of study-level covariates. The risk of bias was assessed using the Cochrane Risk of Bias 2 tool, and the certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation. Results: Of 14,078 hits, 130 randomized controlled trials were included. Compared with usual care or minimal intervention, digital health interventions increased objectively measured physical activity (end of intervention: standardized mean difference [SMD] 0.29, 95% CI 0.21-0.37; follow-up: SMD 0.17, 95% CI 0.04-0.31) and physical function (end of intervention: SMD 0.36, 95% CI 0.12-0.59; follow-up: SMD 0.29, 95% CI 0.01-0.57). The secondary outcomes also favored the digital health interventions for subjectively measured physical activity and physical function, depression, anxiety, and health-related quality of life at the end of the intervention but only subjectively measured physical activity at follow-up. The risk of nonserious adverse events, but not serious adverse events, was higher in the digital health interventions at the end of the intervention, but no difference was seen at follow-up. Conclusions: Digital health interventions improved physical activity and physical function across various chronic conditions. Effects on depression, anxiety, and health-related quality of life were only observed at the end of the intervention. The risk of nonserious adverse events is present during the intervention, which should be addressed. Future studies should focus on better reporting, comparing the effects of different digital health solutions, and investigating how intervention effects are sustained beyond the end of the intervention. Trial Registration: PROSPERO CRD42020189028; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=189028 %M 37410534 %R 10.2196/46439 %U https://www.jmir.org/2023/1/e46439 %U https://doi.org/10.2196/46439 %U http://www.ncbi.nlm.nih.gov/pubmed/37410534 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e41113 %T Economic Evaluations of Digital Health Interventions for the Management of Musculoskeletal Disorders: Systematic Review and Meta-Analysis %A Fatoye,Francis %A Gebrye,Tadesse %A Mbada,Chidozie %A Useh,Ushotanefe %+ Department of Health Professions, Manchester Metropolitan University, Birley Fields Campus, Bonsall Street, Manchester, M156GX, United Kingdom, 44 0044161247296, f.fatoye@mmu.ac.uk %K musculoskeletal disorders %K digital health interventions %K cost-effectiveness %K systematic review %K digital health %K intervention %K management %K musculoskeletal %K muscles %K joints %K nerves %K blood %K pain %K knee %K hip %D 2023 %7 6.7.2023 %9 Review %J J Med Internet Res %G English %X Background: Musculoskeletal disorders (MSDs) are widespread in many countries and their huge burden on the society has necessitated innovative approaches such as digital health interventions. However, no study has evaluated the findings of cost-effectiveness of these interventions. Objective: This study aims to synthesize the cost-effectiveness of digital health interventions for people with MSDs. Methods: Electronic databases including MEDLINE, AMED, CIHAHL, PsycINFO, Scopus, Web of Science, and Centre for Review and Dissemination were searched for cost-effectiveness of digital health published between inception and June 2022 following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. References of all retrieved articles were checked for relevant studies. Quality appraisal of the included studies was performed using the Quality of Health Economic Studies (QHES) instrument. Results were presented using a narrative synthesis and random effects meta-analysis. Results: A total of 10 studies from 6 countries met the inclusion criteria. Using the QHES instrument, we found that the mean score of the overall quality of the included studies was 82.5. Included studies were on nonspecific chronic low back pain (n=4), chronic pain (n=2), knee and hip osteoarthritis (n=3), and fibromyalgia (n=1). The economic perspectives adopted in the included studies were societal (n=4), societal and health care (n=3), and health care (n=3). Of the 10 included studies, 5 (50%) used quality-adjusted life-years as the outcome measures. Except 1 study, all the included studies reported that digital health interventions were cost-effective compared with the control group. In a random effects meta-analysis (n=2), the pooled disability and quality-adjusted life-years were –0.176 (95% CI –0.317 to –0.035; P=.01) and 3.855 (95% CI 2.023 to 5.687; P<.001), respectively. The meta-analysis (n=2) for the costs was in favor of the digital health intervention compared with control: US $417.52 (95% CI –522.01 to –313.03). Conclusions: Studies indicate that digital health interventions are cost-effective for people with MSDs. Our findings suggest that digital health intervention could help improve access to treatment for patients with MSDs and as a result improve their health outcomes. Clinicians and policy makers should consider the use of these interventions for patients with MSDs. Trial Registration: PROSPERO CRD42021253221; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=253221 %M 37410542 %R 10.2196/41113 %U https://www.jmir.org/2023/1/e41113 %U https://doi.org/10.2196/41113 %U http://www.ncbi.nlm.nih.gov/pubmed/37410542 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43051 %T A Multilingual Digital Mental Health and Well-Being Chatbot (ChatPal): Pre-Post Multicenter Intervention Study %A Potts,Courtney %A Lindström,Frida %A Bond,Raymond %A Mulvenna,Maurice %A Booth,Frederick %A Ennis,Edel %A Parding,Karolina %A Kostenius,Catrine %A Broderick,Thomas %A Boyd,Kyle %A Vartiainen,Anna-Kaisa %A Nieminen,Heidi %A Burns,Con %A Bickerdike,Andrea %A Kuosmanen,Lauri %A Dhanapala,Indika %A Vakaloudis,Alex %A Cahill,Brian %A MacInnes,Marion %A Malcolm,Martin %A O'Neill,Siobhan %+ School of Psychology, Ulster University, Cromore Road, Coleraine, BT52 1SA, United Kingdom, 44 28953675, c.potts@ulster.ac.uk %K conversational user interfaces %K digital interventions %K Warwick-Edinburgh Mental Well-Being Scale %K Satisfaction With Life Scale %K World Health Organization-Five Well-Being Index Scale %K mental health %K apps %K health care %K mixed methods %K conversation agent %K mental well-being %K digital health intervention %D 2023 %7 6.7.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: In recent years, advances in technology have led to an influx of mental health apps, in particular the development of mental health and well-being chatbots, which have already shown promise in terms of their efficacy, availability, and accessibility. The ChatPal chatbot was developed to promote positive mental well-being among citizens living in rural areas. ChatPal is a multilingual chatbot, available in English, Scottish Gaelic, Swedish, and Finnish, containing psychoeducational content and exercises such as mindfulness and breathing, mood logging, gratitude, and thought diaries. Objective: The primary objective of this study is to evaluate a multilingual mental health and well-being chatbot (ChatPal) to establish if it has an effect on mental well-being. Secondary objectives include investigating the characteristics of individuals that showed improvements in well-being along with those with worsening well-being and applying thematic analysis to user feedback. Methods: A pre-post intervention study was conducted where participants were recruited to use the intervention (ChatPal) for a 12-week period. Recruitment took place across 5 regions: Northern Ireland, Scotland, the Republic of Ireland, Sweden, and Finland. Outcome measures included the Short Warwick-Edinburgh Mental Well-Being Scale, the World Health Organization-Five Well-Being Index, and the Satisfaction with Life Scale, which were evaluated at baseline, midpoint, and end point. Written feedback was collected from participants and subjected to qualitative analysis to identify themes. Results: A total of 348 people were recruited to the study (n=254, 73% female; n=94, 27% male) aged between 18 and 73 (mean 30) years. The well-being scores of participants improved from baseline to midpoint and from baseline to end point; however, improvement in scores was not statistically significant on the Short Warwick-Edinburgh Mental Well-Being Scale (P=.42), the World Health Organization-Five Well-Being Index (P=.52), or the Satisfaction With Life Scale (P=.81). Individuals that had improved well-being scores (n=16) interacted more with the chatbot and were significantly younger compared to those whose well-being declined over the study (P=.03). Three themes were identified from user feedback, including “positive experiences,” “mixed or neutral experiences,” and “negative experiences.” Positive experiences included enjoying exercises provided by the chatbot, while most of the mixed, neutral, or negative experiences mentioned liking the chatbot overall, but there were some barriers, such as technical or performance errors, that needed to be overcome. Conclusions: Marginal improvements in mental well-being were seen in those who used ChatPal, albeit nonsignificant. We propose that the chatbot could be used along with other service offerings to complement different digital or face-to-face services, although further research should be carried out to confirm the effectiveness of this approach. Nonetheless, this paper highlights the need for blended service offerings in mental health care. %M 37410537 %R 10.2196/43051 %U https://www.jmir.org/2023/1/e43051 %U https://doi.org/10.2196/43051 %U http://www.ncbi.nlm.nih.gov/pubmed/37410537 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 9 %N %P e44533 %T A Mobile App to Support Self-Management in Patients with Multiple Myeloma or Chronic Lymphocytic Leukemia: Pilot Randomized Controlled Trial %A LeBlanc,Matthew R %A LeBlanc,Thomas W %A Yang,Qing %A McLaughlin,Jennifer %A Irish,Kerry %A Smith,Sophia K %+ School of Nursing, University of North Carolina at Chapel Hill, 120 N Medical Drive, CB 7460, Chapel Hill, NC, 27599, United States, 1 919 966 4260, matthew_leblanc@unc.edu %K chronic lymphocytic leukemia %K distress %K intervention %K leukemia %K mHealth %K mobile application %K multiple myeloma %K post-traumatic stress %K self-management %K symptoms %K treatment %D 2023 %7 6.7.2023 %9 Original Paper %J JMIR Cancer %G English %X Background: Patients with blood cancer experience serious physical and emotional symptoms throughout their cancer journey. Objective: Building on previous work, we aimed to develop an app designed to help patients with multiple myeloma and chronic lymphocytic leukemia self-manage symptoms and test it for acceptability and preliminary efficacy. Methods: We developed our Blood Cancer Coach app with input from clinicians and patients. Our 2-armed randomized controlled pilot trial recruited participants from Duke Health and nationally in partnerships with the Association of Oncology Social Work, Leukemia and Lymphoma Society, and other patient groups. Participants were randomized to the attention control (Springboard Beyond Cancer website) arm or the Blood Cancer Coach app intervention arm. The fully automated Blood Cancer Coach app included symptom and distress tracking with tailored feedback, medication reminders and adherence tracking, multiple myeloma and chronic lymphocytic leukemia education resources, and mindfulness activities. Patient-reported data were collected at baseline, 4 weeks, and 8 weeks for both arms through the Blood Cancer Coach app. Outcomes of interest were global health (Patient Reported Outcomes Measurement Information System Global Health), posttraumatic stress (Posttraumatic Stress Disorder Checklist for DSM-5), and cancer symptoms (Edmonton Symptom Assessment System Revised). Among participants in the intervention arm, satisfaction surveys and usage data were used to evaluate acceptability. Results: Among 180 patients who downloaded the app, 49% (89) of them consented to participate and 40% (72) of them completed baseline surveys. Of those who completed baseline surveys, 53% (38) of them completed week 4 surveys (16 intervention and 22 control) and 39% (28) of them completed week 8 surveys (13 intervention and 15 control). Most participants found the app at least moderately effective at helping manage symptoms (87%), feeling more comfortable seeking help (87%), increasing awareness of resources (73%), and reported being satisfied with the app overall (73%). Participants completed an average of 248.5 app tasks over the 8-week study period. The most used functions within the app were medication log, distress tracking, guided meditations, and symptom tracking. There were no significant differences between the control and intervention arms at week 4 or 8 on any outcomes. We also saw no significant improvement over time within the intervention arm. Conclusions: The results of our feasibility pilot were promising in which most participants found the app to be helpful in managing their symptoms, reported satisfaction with the app, and that it was helpful in several important areas. We did not, however, find significantly reduced symptoms or improved global mental and physical health over 2 months. Recruitment and retention were challenging for this app-based study, an experience echoed by others. Limitations included a predominantly White and college educated sample. Future studies would do well to include self-efficacy outcomes, target those with more symptoms, and emphasize diversity in recruitment and retention. Trial Registration: ClinicalTrials.gov NCT05928156; https://clinicaltrials.gov/study/NCT05928156 %M 37410541 %R 10.2196/44533 %U https://cancer.jmir.org/2023/1/e44533 %U https://doi.org/10.2196/44533 %U http://www.ncbi.nlm.nih.gov/pubmed/37410541 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47516 %T Feasibility, Engagement, and Usability of a Remote, Smartphone-Based Contingency Management Program as a Treatment Add-On for Patients Who Use Methamphetamine: Single-Arm Pilot Study %A Hallgren,Kevin A %A Duncan,Mark H %A Iles-Shih,Matthew D %A Cohn,Eliza B %A McCabe,Connor J %A Chang,Yanni M %A Saxon,Andrew J %+ Department of Psychiatry and Behavioral Sciences, University of Washington, Box 356560, 1959 NE Pacific St., Seattle, WA, 98195, United States, 1 206 616 2906, khallgre@uw.edu %K contingency management %K methamphetamine use disorder %K mobile health %K mHealth %K mobile phone %D 2023 %7 6.7.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: In the United States, methamphetamine-related overdoses have tripled from 2015 to 2020 and continue to rise. However, efficacious treatments such as contingency management (CM) are often unavailable in health systems. Objective: We conducted a single-arm pilot study to evaluate the feasibility, engagement, and usability of a fully remotely delivered mobile health CM program offered to adult outpatients who used methamphetamine and were receiving health care within a large university health system. Methods: Participants were referred by primary care or behavioral health clinicians between September 2021 and July 2022. Eligibility criteria screening was conducted by telephone and included self-reported methamphetamine use on ≥5 out of the past 30 days and a goal of reducing or abstaining from methamphetamine use. Eligible participants who agreed to take part then completed an initial welcome phase that included 2 videoconference calls to register for and learn about the CM program and 2 “practice” saliva-based substance tests prompted by a smartphone app. Participants who completed these welcome phase activities could then receive the remotely delivered CM intervention for 12 consecutive weeks. The intervention included approximately 24 randomly scheduled smartphone alerts requesting a video recording of themselves taking a saliva-based substance test to verify recent methamphetamine abstinence, 12 weekly calls with a CM guide, 35 self-paced cognitive behavioral therapy modules, and multiple surveys. Financial incentives were disbursed via reloadable debit cards. An intervention usability questionnaire was completed at the midpoint. Results: Overall, 37 patients completed telephone screenings, with 28 (76%) meeting the eligibility criteria and consenting to participate. Most participants who completed a baseline questionnaire (21/24, 88%) self-reported symptoms consistent with severe methamphetamine use disorder, and most had other co-occurring non-methamphetamine substance use disorders (22/28, 79%) and co-occurring mental health disorders (25/28, 89%) according to existing electronic health records. Overall, 54% (15/28) of participants successfully completed the welcome phase and were able to receive the CM intervention. Among these participants, engagement with substance testing, calls with CM guides, and cognitive behavioral therapy modules varied. Rates of verified methamphetamine abstinence in substance testing were generally low but varied considerably across participants. Participants reported positive opinions about the intervention’s ease of use and satisfaction with the intervention. Conclusions: Fully remote CM can be feasibly delivered within health care settings lacking existing CM programs. Although remote delivery may help reduce barriers to treatment access, many patients who use methamphetamine may struggle to engage with initial onboarding. High rates of co-occurring psychiatric conditions in the patient population may also contribute to uptake and engagement challenges. Future efforts could leverage greater human-to-human connection, more streamlined onboarding procedures, larger incentives, longer durations, and the incentivization of non–abstinence-based recovery goals to increase uptake and engagement with fully remote mobile health–based CM. %M 37410529 %R 10.2196/47516 %U https://formative.jmir.org/2023/1/e47516 %U https://doi.org/10.2196/47516 %U http://www.ncbi.nlm.nih.gov/pubmed/37410529 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43869 %T The Association Between Goal Setting and Weight Loss: Prospective Analysis of a Community Weight Loss Program %A Wren,Gina M %A Koutoukidis,Dimitrios A %A Scragg,Jadine %A Whitman,Michael %A Jebb,Susan %+ Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care Building, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, United Kingdom, 44 01865 ext 617855, gina.wren@phc.ox.ac.uk %K obesity %K overweight %K weight loss %K goals %K motivation %K mobile app %K mobile health %K mHealth %K behavior change %K mobile phone %D 2023 %7 5.7.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Goal setting aids health-related behavior changes; however, the influence of different types of goals on weight loss remains unclear. Objective: We aimed to investigate the association of 3 aspects of goal setting with weight and program dropout over a 24-week period. Methods: This study was a prospective longitudinal analysis of participants in a 12-week digital behavioral weight loss program. Weight and engagement data for eligible participants (N=36,794) were extracted from the database. Eligible participants were adults in the United Kingdom who had enrolled in the program, had a BMI ≥25 kg/m2, and a weight reading recorded at baseline. Three aspects of goal setting were self-reported at enrollment: weight loss motivation (appearance, health, fitness, or self-efficacy), overall goal preference (low, medium, or high), and percentage weight loss goal (<5%, 5%-10%, or >10%). Weight was measured at 4, 12, and 24 weeks. Mixed models for repeated measures were used to explore the association between goals and weight across the 24-week period. To measure sustained weight change, the primary outcome was weight at 24 weeks. We explored dropout rates over the 24-week period by goal and whether engagement mediated the association between goals and weight loss. Results: Of the 36,794 participants (mean 46.7, SD 11.1 years; 33,902/36,794, 92.14% female) included in the cohort, 13.09% (n=4818) reported weight at 24 weeks. Most participants set goals of 5%-10% weight loss (23,629/36,794, 64.22%), but setting goals for >10% was associated with greater weight loss (mean difference 5.21 kg, 95% CI 5.01-5.41; P<.001). There was no difference between goals of 5%-10% and <5% (mean difference 0.59 kg, 95% CI 0.00-1.18; P=.05). Appearance was the most prevalent motivational factor (14,736/36,794, 40.05%), but health and fitness were associated with greater weight losses (mean difference health vs appearance 1.40 kg, 95% CI 1.15-1.65; P<.001 and mean difference fitness vs appearance 0.38 kg, 95% CI 0.05-0.70; P=.03). Goal preference had no association with weight. Engagement was an independent predictor of weight loss but not a mediator of the effect of goal setting. At 24 weeks, those who set goals of >10% were less likely to drop out compared with 5%-10% goals (odds ratio [OR] 0.40, 95% CI 0.38-0.42; P<.001); those who liked to set overall high goals were more likely to drop out compared with medium goals (OR 1.20, 95% CI 1.11-1.29; P<.001); and those motivated by fitness or health were less likely to drop out compared with appearance (OR 0.92, 95% CI 0.85-0.995; P=.04 and OR 0.84, 95% CI 0.78-0.89; P<.001, respectively). Conclusions: Setting higher weight loss goals and being motivated by health or fitness were associated with greater weight loss and lower likelihood of dropout. Randomized trials for setting these types of goals are required to confirm causality. %M 37405833 %R 10.2196/43869 %U https://www.jmir.org/2023/1/e43869 %U https://doi.org/10.2196/43869 %U http://www.ncbi.nlm.nih.gov/pubmed/37405833 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42551 %T Adaptation and Implementation of a Shared Decision-Making Tool From One Health Context to Another: Partnership Approach Using Mixed Methods %A Turnbull,Sophie %A Walsh,Nicola E %A Moore,Andrew J %+ Population Health Sciences, University of Bristol, Canyange Hall, Bristol, BS8 2PN, United Kingdom, 44 117 928 7279, st9866@bristol.ac.uk %K shared decision-making %K implementation %K theoretical domains framework %K qualitative %K osteoarthritis %K digital %K mixed methods study %K decision-making %K disability %K treatment %K tool %K effectiveness %K acceptability %K users %K design %D 2023 %7 5.7.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Osteoarthritis is a leading cause of pain and disability. Knee osteoarthritis accounts for nearly four-fifths of the burden of osteoarthritis internationally, and 10% of adults in the United Kingdom have the condition. Shared decision-making (SDM) supports patients to make more informed choices about treatment and care while reducing inequities in access to treatment. We evaluated the experience of a team adapting an SDM tool for knee osteoarthritis and the tool’s implementation potential within a local clinical commissioning group (CCG) area in southwest England. The tool aims to prepare patients and clinicians for SDM by providing evidence-based information about treatment options relevant to disease stage. Objective: This study aimed to explore the experiences of a team adapting an SDM tool from one health context to another and the implementation potential of the tool in the local CCG area. Methods: A partnership approach using mixed methods was used to respond to recruitment challenges and ensure that study aims could be addressed within time restrictions. A web-based survey was used to obtain clinicians’ feedback on experiences of using the SDM tool. Qualitative interviews were conducted by telephone or video call with a sample of stakeholders involved in adapting and implementing the tool in the local CCG area. Survey findings were summarized as frequencies and percentages. Content analysis was conducted on qualitative data using framework analysis, and data were mapped directly to the Theoretical Domains Framework (TDF). Results: Overall, 23 clinicians completed the survey, including first-contact physiotherapists (11/23, 48%), physiotherapists (7/23, 30%), specialist physiotherapists (4/23, 17%), and a general practitioner (1/23, 4%). Eight stakeholders involved in commissioning, adapting, and implementing the SDM tool were interviewed. Participants described barriers and facilitators to the adaptation, implementation, and use of the tool. Barriers included a lack of organizational culture that supported and resourced SDM, lack of clinician buy-in and awareness of the tool, challenges with accessibility and usability, and lack of adaptation for underserved communities. Facilitators included the influence of clinical leaders’ belief that SDM tools can improve patient outcomes and National Health Service resource use, clinicians’ positive experiences of using the tool, and improving awareness of the tool. Themes were mapped to 13 of the 14 TDF domains. Usability issues were described, which did not map to the TDF domains. Conclusions: This study highlights barriers and facilitators to adapting and implementing tools from one health context to another. We recommend that tools selected for adaptation should have a strong evidence base, including evidence of effectiveness and acceptability in the original context. Legal advice should be sought regarding intellectual property early in the project. Existing guidance for developing and adapting interventions should be used. Co-design methods should be applied to improve adapted tools’ accessibility and acceptability. %M 37405845 %R 10.2196/42551 %U https://www.jmir.org/2023/1/e42551 %U https://doi.org/10.2196/42551 %U http://www.ncbi.nlm.nih.gov/pubmed/37405845 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e43214 %T Caregivers’ Experiences With a Web- and Mobile-Based Platform for Children With Medical Complexity and the Role of a Live Platform Coach: Thematic Analysis %A Shouldice,Ainslie Claire %A Beatty,Madison %A Adams,Sherri %A Dharmaraj,Blossom %A Moore,Clara %A Stinson,Jennifer Nan %A Desai,Arti %A Bartlett,Leah %A Culbert,Erin %A Cohen,Eyal %A Orkin,Julia %+ Child Health Evaluative Sciences, SickKids Research Institute, The Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada, 1 4168137654, ainslie.shouldice@gmail.com %K care coordination %K care %K children with medical complexity %K children %K chronic condition %K electronic data %K engagement %K health information exchange %K medical %K patient care planning %K pediatrics %K usage %K utilization %D 2023 %7 5.7.2023 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Children with medical complexity (CMC) are individuals with complex chronic conditions who have substantial health care needs, functional limitations, and significant use of health care. By nature of their health status, they have many care providers across multiple settings, making information sharing critical to their health and safety. Connecting2gether (C2), a web- and mobile-based patient-facing platform, was codeveloped with families to support and empower parental caregivers, improve information sharing, and facilitate care delivery. C2 also provided a live platform coach to conduct parental feedback and coaching sessions, which included answering questions, providing advice on usage, and addressing technological issues. Objective: This study was conducted to understand the experience of parental caregivers using the C2 platform and the role of the live platform coach. This study is a subset of a larger study assessing the feasibility of C2 in the care of CMC. Methods: Parental caregivers (n=33) participated in biweekly sessions to provide feedback and receive real-time platform use support from a trained research team member acting as a live platform coach. Parental caregivers were asked about the utility and usability of C2’s features. Questions, platform issues, and feedback were recorded on a standardized electronic data collection tool. A thematic analysis was performed to analyze parental comments, and codes were categorized into key themes. The number of comments corresponding with each code was quantified. Results: A total of 166 parental feedback and coaching sessions were conducted, with an average of 5 sessions per parental caregiver (range 1-7). There were 33 (85%) parental caregivers that participated in at least one coaching session. Technical issues and difficulties navigating C2 were addressed in real time during the sessions to encourage platform engagement. Four key themes were identified: (1) live platform coach, (2) barriers to platform usage and technical challenges, (3) platform requests and modifications, and (4) parent partnership and empowerment. Conclusions: Parental caregivers describe C2 as a valuable tool, acting as a facilitator for enhanced care coordination and communication. Parental caregiver feedback showed that the live platform coach was a critical tool in educating on platform use and addressing technological concerns. Further study of the use of the C2 platform and its role in the care of CMC is needed to understand the possible benefits and cost-effectiveness of this technology. %M 37405834 %R 10.2196/43214 %U https://pediatrics.jmir.org/2023/1/e43214 %U https://doi.org/10.2196/43214 %U http://www.ncbi.nlm.nih.gov/pubmed/37405834 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43304 %T Digitally Assisted Peer Recovery Coach to Facilitate Linkage to Outpatient Treatment Following Inpatient Alcohol Withdrawal Treatment: Proof-of-Concept Pilot Study %A Suzuki,Joji %A Loguidice,Frank %A Prostko,Sara %A Szpak,Veronica %A Sharma,Samata %A Vercollone,Lisa %A Garner,Carol %A Ahern,David %+ Department of Psychiatry, Brigham and Women's Hospital, 60 Fenwood Rd, Room 4168, Boston, MA, 02474, United States, 1 6174557981, jsuzuki2@bwh.harvard.edu %K alcohol use disorder %K inpatient detoxification %K peer recovery coach %K smartphone app %K alcohol %K substance use %K substance abuse %K drinking %K recovery %K peer support %K detox %K coaching %K health app %K mobile health %K mHealth %K mobile app %K care coordination %K digitally %K detoxification %K Lifeguard %K peer recovery %K inpatient alcohol %D 2023 %7 5.7.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Alcohol use disorder (AUD), associated with significant morbidity and mortality, continues to be a major public health problem. The COVID-19 pandemic exacerbated the impact of AUD, with a 25% increase in alcohol-related mortality from 2019 to 2020. Thus, innovative treatments for AUD are urgently needed. While inpatient alcohol withdrawal management (detoxification) is often an entry point for recovery, most do not successfully link to ongoing treatment. Transitions between inpatient and outpatient treatment pose many challenges to successful treatment continuation. Peer recovery coaches—individuals with the lived experience of recovery who obtain training to be coaches—are increasingly used to assist individuals with AUD and may provide a degree of continuity during this transition. Objective: We aimed to evaluate the feasibility of using an existing care coordination app (Lifeguard) to assist peer recovery coaches in supporting patients after discharge and facilitating linkage to care. Methods: This study was conducted on an American Society of Addiction Medicine–Level IV inpatient withdrawal management unit within an academic medical center in Boston, MA. After providing informed consent, participants were contacted by the coach through the app, and after discharge, received daily prompts to complete a modified version of the brief addiction monitor (BAM). The BAM inquired about alcohol use, risky, and protective factors. The coach sent daily motivational texts and appointment reminders and checked in if BAM responses were concerning. Postdischarge follow-up continued for 30 days. The following feasibility outcomes were evaluated: (1) proportion of participants engaging with the coach before discharge, (2) proportion of participants and the number of days engaging with the coach after discharge, (3) proportion of participants and the number of days responding to BAM prompts, and (4) proportion of participants successfully linking with addiction treatment by 30-day follow-up. Results: All 10 participants were men, averaged 50.5 years old, and were mostly White (n=6), non-Hispanic (n=9), and single (n=8). Overall, 8 participants successfully engaged with the coach prior to discharge. Following discharge, 6 participants continued to engage with the coach, doing so on an average of 5.3 days (SD 7.3, range 0-20 days); 5 participants responded to the BAM prompts during the follow-up, doing so on an average of 4.6 days (SD 6.9, range 0-21 days). Half (n=5) successfully linked with ongoing addiction treatment during the follow-up. The participants who engaged with the coach post discharge, compared to those who did not, were significantly more likely to link with treatment (83% vs 0%, χ2=6.67, P=.01). Conclusions: The results demonstrated that a digitally assisted peer recovery coach may be feasible in facilitating linkage to care following discharge from inpatient withdrawal management treatment. Further research is warranted to evaluate the potential role for peer recovery coaches in improving postdischarge outcomes. Trial Registration: ClinicalTrials.gov NCT05393544; https://www.clinicaltrials.gov/ct2/show/NCT05393544 %M 37405844 %R 10.2196/43304 %U https://formative.jmir.org/2023/1/e43304 %U https://doi.org/10.2196/43304 %U http://www.ncbi.nlm.nih.gov/pubmed/37405844 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46325 %T A Trauma-Informed HIV Intervention (LinkPositively) to Improve HIV Care Among Black Women Affected by Interpersonal Violence: Protocol for a Pilot Randomized Controlled Trial %A Stockman,Jamila K %A Anderson,Katherine M %A Fernandez DeSoto,Alexandra %A Campbell,Danielle M %A Tsuyuki,Kiyomi %A Horvath,Keith J %+ Division of Infectious Diseases and Global Public Health, Department of Medicine, University of California, San Diego, 9500 Gilman Drive, MC 0507, La Jolla, CA, 92093-0507, United States, 1 858 822 4652, jstockman@health.ucsd.edu %K HIV %K peer navigation %K social networking %K Black women %K interpersonal violence %K web application %K randomized controlled trial %K mobile phone %D 2023 %7 5.7.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Black women bear a disproportionate burden of HIV, accounting for nearly 60% of new diagnoses among US women. Black women living with HIV often experience mutually reinforcing epidemics, known as syndemics, including interpersonal violence and substance use. Syndemics are associated with decreased HIV care engagement and treatment adherence and worsening HIV outcomes. Few HIV services and resources are tailored to be culturally and gender-responsive and trauma informed for Black women living with HIV. Technology-based, psychoeducational, and peer navigation programs offer promising pathways to tailored HIV support and improved HIV care outcomes. Therefore, the web-based, trauma-informed intervention LinkPositively was developed in collaboration with Black women living with HIV to promote uptake of HIV care and ancillary support services. Objective: This study primarily determines the feasibility and acceptability of the LinkPositively intervention among Black women living with HIV affected by interpersonal violence. The secondary aim is to examine the preliminary impact of the LinkPositively intervention on retention in HIV care, antiretroviral therapy adherence, and viral suppression while evaluating the role of mechanism of change variables (eg, social support) in the associations. Methods: The LinkPositively trial is a pilot randomized controlled trial conducted in California, United States, among 80 adult Black women living with HIV who have experienced interpersonal violence. Core components of LinkPositively include one-on-one peer navigation with phone and SMS text message check-ins; 5 weekly one-on-one video sessions to build coping and care navigation skills; and a mobile app that contains a peer support social networking platform, an educational database with healthy living and self-care tips, a GPS-enabled HIV and ancillary care resource locator, and a medication self-monitoring and reminder system. Participants are randomly assigned to the intervention (n=40) or control (Ryan White standard of care; n=40) arm, with follow-up at 3 and 6 months. At each assessment, participants complete an interviewer-administered survey and submit hair samples for the assessment of HIV medication adherence. All research staff and investigators adhere to ethical principles and guidelines for conducting research activities. Data will be analyzed using generalized estimating equations. Results: Final development and testing of the LinkPositively app were completed in July 2021. As of May 2023, we have screened 97 women for eligibility. Of the 97 women screened, 27 (28%) were eligible and have been enrolled in the study. The dissemination of preliminary results will occur in 2024. Conclusions: This trial will advance HIV prevention science by harnessing technology to promote engagement in HIV care while improving social support through peers and social networking—all while being trauma informed for Black women living with HIV with experiences of interpersonal violence. If shown to be feasible and acceptable, LinkPositively has the potential to improve HIV care outcomes among Black women, a marginalized key population. International Registered Report Identifier (IRRID): DERR1-10.2196/46325 %M 37405824 %R 10.2196/46325 %U https://www.researchprotocols.org/2023/1/e46325 %U https://doi.org/10.2196/46325 %U http://www.ncbi.nlm.nih.gov/pubmed/37405824 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46135 %T Adaptive P300-Based Brain-Computer Interface for Attention Training: Protocol for a Randomized Controlled Trial %A Noble,Sandra-Carina %A Woods,Eva %A Ward,Tomas %A Ringwood,John V %+ Department of Electronic Engineering, Maynooth University, BioScience & Electronic Engineering Building, Maynooth, W23 F2H6, Ireland, 353 17084760, sandracarina.noble.2017@mumail.ie %K ADHD %K attention %K BCI %K brain-computer interface %K cognitive deficit %K cognitive disease %K cognitive training %K dementia %K EEG %K electroencephalography %K ERP %K event-related potential %K neurodegeneration %K neurofeedback training %K P300 speller %K stroke %D 2023 %7 5.7.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: The number of people with cognitive deficits and diseases, such as stroke, dementia, or attention-deficit/hyperactivity disorder, is rising due to an aging, or in the case of attention-deficit/hyperactivity disorder, a growing population. Neurofeedback training using brain-computer interfaces is emerging as a means of easy-to-use and noninvasive cognitive training and rehabilitation. A novel application of neurofeedback training using a P300-based brain-computer interface has previously shown potential to improve attention in healthy adults. Objective: This study aims to accelerate attention training using iterative learning control to optimize the task difficulty in an adaptive P300 speller task. Furthermore, we hope to replicate the results of a previous study using a P300 speller for attention training, as a benchmark comparison. In addition, the effectiveness of personalizing the task difficulty during training will be compared to a nonpersonalized task difficulty adaptation. Methods: In this single-blind, parallel, 3-arm randomized controlled trial, 45 healthy adults will be recruited and randomly assigned to the experimental group or 1 of 2 control groups. This study involves a single training session, where participants receive neurofeedback training through a P300 speller task. During this training, the task’s difficulty is progressively increased, which makes it more difficult for the participants to maintain their performance. This encourages the participants to improve their focus. Task difficulty is either adapted based on the participants’ performance (in the experimental group and control group 1) or chosen randomly (in control group 2). Changes in brain patterns before and after training will be analyzed to study the effectiveness of the different approaches. Participants will complete a random dot motion task before and after the training so that any transfer effects of the training to other cognitive tasks can be evaluated. Questionnaires will be used to estimate the participants’ fatigue and compare the perceived workload of the training between groups. Results: This study has been approved by the Maynooth University Ethics Committee (BSRESC-2022-2474456) and is registered on ClinicalTrials.gov (NCT05576649). Participant recruitment and data collection began in October 2022, and we expect to publish the results in 2023. Conclusions: This study aims to accelerate attention training using iterative learning control in an adaptive P300 speller task, making it a more attractive training option for individuals with cognitive deficits due to its ease of use and speed. The successful replication of the results from the previous study, which used a P300 speller for attention training, would provide further evidence to support the effectiveness of this training tool. Trial Registration: ClinicalTrials.gov NCT05576649; https://clinicaltrials.gov/ct2/show/NCT05576649 International Registered Report Identifier (IRRID): DERR1-10.2196/46135 %M 37405822 %R 10.2196/46135 %U https://www.researchprotocols.org/2023/1/e46135 %U https://doi.org/10.2196/46135 %U http://www.ncbi.nlm.nih.gov/pubmed/37405822 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44400 %T mHealth Early Intervention to Reduce Posttraumatic Stress and Alcohol Use After Sexual Assault (THRIVE): Feasibility and Acceptability Results From a Pilot Trial %A Dworkin,Emily R %A Schallert,Macey %A Lee,Christine M %A Kaysen,Debra %+ Department of Psychiatry & Behavioral Sciences, University of Washington School of Medicine, 1959 NE Pacific St., Box 356560, Seattle, WA, 98195, United States, 1 206 221 6932, edworkin@uw.edu %K mobile health %K mHealth %K mobile apps %K prevention %K alcohol use %K trauma %K sexual violence %K rape %K mobile phone %D 2023 %7 4.7.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Sexual assault is associated with increased risk for both posttraumatic stress (PTS) and alcohol misuse. Mobile health interventions have shown promise in addressing PTS and substance use in trauma survivors and might be a promising strategy in extending the reach of early interventions to individuals who have recently experienced trauma. Objective: This study assesses the feasibility and acceptability of THRIVE, a mobile health early intervention for recent survivors of sexual assault involving a cognitive behavioral app used daily over 21 days with weekly telephone coaching. Methods: Twenty adult female survivors of past–10-week sexual assault with elevated PTS and alcohol use were randomized to receive the THRIVE intervention as part of a pilot randomized controlled trial. We sought to understand feasibility by examining rates of completion of intervention activities and testing changes in participants’ self-reported knowledge of key intervention concepts from baseline to after the intervention. We assessed acceptability by collecting self-report ratings of satisfaction with the intervention and app usability in a follow-up survey. The coach took notes during coaching calls to track call content and record participant feedback; these notes were qualitatively analyzed to elaborate on the aforementioned domains. Results: Feasibility was demonstrated by moderate rates of activity completion: all participants at least opened the app, 19 (95%) of the 20 participants completed at least 1 cognitive behavioral exercise, and 16 (80%) of the 20 participants attended all 4 coaching calls. Participants completed cognitive behavioral exercises on an average of 10.40 (SD 6.52) out of 21 days. The coaching call notes documented participant comments that app-generated reminders increased completion rates. Feasibility was also demonstrated by the finding that knowledge changes occurred from baseline to after the intervention; this indicated that THRIVE was successful in conveying key concepts. Acceptability was demonstrated by high participant ratings of THRIVE’s usability; the ratings corresponded to a B+ usability grade. The coaching call notes documented that usability was increased by the coaching calls, the app exercises’ clarity, and the app exercises’ inclusion of suggestions; however, the coaching call notes also documented that some of the participants found aspects of the app exercises to be difficult or confusing. Acceptability was also demonstrated by participant ratings of satisfaction: most of the participants (15/16, 94%) rated the app as either moderately helpful or very helpful. The coaching call notes documented that the cognitive behavioral activity modules were seen as appealing and that the positive impact of the intervention contributed to participants’ satisfaction. Conclusions: These findings suggest that THRIVE is feasible and acceptable to survivors of recent sexual assault and that further testing of THRIVE is warranted. Trial Registration: ClinicalTrials.gov NCT03703258; https://clinicaltrials.gov/ct2/show/NCT03703258 %M 37402144 %R 10.2196/44400 %U https://formative.jmir.org/2023/1/e44400 %U https://doi.org/10.2196/44400 %U http://www.ncbi.nlm.nih.gov/pubmed/37402144 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42317 %T The Mediating Role of General and Cognitive Stress on the Effect of an App-Based Intervention on Productivity Measures in Workers: Randomized Controlled Trial %A de Miquel,Carlota %A Moneta,Maria Victoria %A Weber,Silvana %A Lorenz,Christopher %A Olaya,Beatriz %A Haro,Josep Maria %+ Research, Innovation and Teaching Unit, Parc Sanitari Sant Joan de Déu, Carrer Doctor Antoni Pujadas 42, Sant Boi de Llobregat, 08830, Spain, 34 93 640 63 50 ext 1, beatriz.olaya@sjd.es %K e-mental health intervention %K work %K absenteeism %K presenteeism %K stress %K mediation %D 2023 %7 3.7.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Loss of productivity is a result of absence from work (absenteeism) or of working with limitations due to illness (presenteeism). Recently, occupational mental health interventions have increasingly been delivered in digital format, as this is thought to be more convenient, flexible, easily accessible, and anonymous. However, the effectiveness of electronic mental health (e-mental health) interventions in the workplace to improve presenteeism and absenteeism remains unknown, and could be potentially mediated by psychological variables such as stress levels. Objective: The aim of this study was to determine the effectiveness of an e-mental health intervention to reduce absenteeism and presenteeism in employees, as well as to investigate the mediating role of stress in this effect. Methods: Employees of six companies in two countries participated in a randomized controlled trial (n=210 in the intervention group and n=322 in the waitlist control group). Participants in the intervention group could use the Kelaa Mental Resilience app for 4 weeks. All participants were asked to complete assessments at baseline, during the intervention, postintervention, and at a 2-week follow-up. Absenteeism and presenteeism were assessed by means of the Work Productivity and Activity Impairment Questionnaire: General Health, while general and cognitive stress were assessed through the Copenhagen Psychosocial Questionnaire-Revised Version. Regression and mediation analyses were performed to evaluate the effect of the Kelaa Mental Resilience app on presenteeism and absenteeism. Results: The intervention did not have a direct effect on presenteeism or absenteeism, neither at postintervention nor at follow-up. Nevertheless, general stress significantly mediated the intervention effect on presenteeism (P=.005) but not on absenteeism (P=.92), and cognitive stress mediated the effect of the intervention on both presenteeism (P<.001) and absenteeism (P=.02) right after the intervention. At the 2-week follow-up, the mediating effect of cognitive stress on presenteeism was significant (P=.04), although this was not the case for its mediating effect on absenteeism (P=.36). Additionally, at the 2-week follow-up, general stress did not mediate the intervention effect on presenteeism (P=.25) or on absenteeism (P=.72). Conclusions: While no direct effect of the e-mental health intervention on productivity was found in this study, our findings suggest that stress reduction could mediate the effect of the intervention on presenteeism and absenteeism. As such, e-mental health interventions that address stress in employees might also indirectly reduce presenteeism and absenteeism in these employees. However, due to study limitations such as an overrepresentation of female participants in the sample and a high proportion of attrition, these results should be interpreted with caution. Future research is needed to better understand the mechanisms of interventions on productivity in the workplace. Trial Registration: ClinicalTrials.gov NCT05924542; https://clinicaltrials.gov/study/NCT05924542 %M 37399056 %R 10.2196/42317 %U https://www.jmir.org/2023/1/e42317 %U https://doi.org/10.2196/42317 %U http://www.ncbi.nlm.nih.gov/pubmed/37399056 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e48913 %T Designing High-Fidelity Mobile Health for Depression in Indonesian Adolescents Using Design Science Research: Mixed Method Approaches %A Shania,Mila %A Handayani,Putu Wuri %A Asih,Sali %+ Faculty of Psychology, University of Indonesia, Jl Kampus UI, Depok, 16424, Indonesia, 62 217863419, Putu.wuri@cs.ui.ac.id %K mobile health %K mental health %K user interface %K design science research %K Indonesia %K digital app %K mHealth %K depression %K pandemic %K adolescents %D 2023 %7 3.7.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: COVID-19 mitigation protocols, enacted to control the pandemic, have also been shown to have a negative impact on mental health, including the mental health of adolescents. The threat of being infected by SARS-CoV-2 and substantial changes in lifestyle, including limited social interaction due to stay-at-home orders, led to loneliness as well as depressive symptoms. However, offline psychological assistance is restricted, as psychologists are bounded by mitigation protocols. Further, not all adolescents’ guardians are open to their children attending or have the means to pay for psychological service; thus, adolescents remain untreated. Having a mobile health (mHealth) app for mental health that uses monitoring, provides social networks, and delivers psychoeducation may provide a solution, especially in countries that have limited health facilities and mental health workers. Objective: This study aimed to design an mHealth app to help prevent and monitor depression in adolescents. The design of this mHealth app was carried out as a high-fidelity prototype. Methods: We used a design science research (DSR) methodology with 3 iterations and 8 golden rule guidelines. The first iteration used interviews, and the second and third iterations used mixed method approaches. The DSR stages include the following: (1) identify the problem; (2) define the solution; (3) define the solution objective; (4) develop, demonstrate, and evaluate the solution; and (5) communicate the solution. This study involved students and medical experts. Results: The first iteration resulted in a wireframe and prototype for the next iteration. The second iteration resulted in a System Usability Scale score of 67.27, indicating a good fit. In the third iteration, the system usefulness, information quality, interface quality, and overall values were 2.416, 2.341, 2.597, and 2.261, respectively, indicating a good design. Key features of this mHealth app include a mood tracker, community, activity target, and meditation, and supporting features that complement the design include education articles and early detection features. Conclusions: Our findings provide guidance for health facilities and to design and implement future mHealth apps to help treat adolescent depression. %M 37399059 %R 10.2196/48913 %U https://formative.jmir.org/2023/1/e48913 %U https://doi.org/10.2196/48913 %U http://www.ncbi.nlm.nih.gov/pubmed/37399059 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e40262 %T Delivering a Home-Based Exercise Program to Youth With Osteogenesis Imperfecta: Protocol for a Comparative-Approach Study %A Powell,Georgia %A Gagnon,Marianne %A Komarova,Svetlana %A Rauch,Frank %A Veilleux,Louis-Nicolas %+ Shriners Hospitals for Children-Canada, 1003 Decarie Blvd, Montreal, QC, H4A 0A9, Canada, 1 (514) 842 4464, ln.veilleux@mcgill.ca %K adherence %K cost-effectiveness %K exercise %K osteogenesis imperfecta %K telemedicine %D 2023 %7 3.7.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Osteogenesis imperfecta (OI) is a rare bone fragility disorder associated with muscle weakness. Individuals with OI may therefore benefit from exercise interventions aiming to improve muscle and bone strength. Given the rarity of OI, many patients do not have access to exercise specialists who are familiar with the disorder. As such, telemedicine, the provision of health care through technology to provide care at a distance, may be well suited for this population. Objective: The main objectives are (1) to investigate the feasibility and cost-effectiveness of 2 telemedicine approaches for the delivery of an exercise intervention for youth with OI and (2) to assess the impact of the exercise intervention on muscle function and cardiopulmonary fitness in youth with OI. Methods: Patients with OI type I (the mildest form of OI; n=12, aged 12-16 years) from a pediatric orthopedic tertiary hospital will be randomized to receive a 12-week remote exercise intervention in either (1) a supervised group (n=6), monitored every session, or (2) a follow-up group (n=6), receiving monthly progress update appointments. Participants will undergo the following pre- and postintervention evaluations: sit-to-stand test, push-up test, sit-up test, single-legged balance test, and a heel-rise test. Both groups will be given the same 12-week exercise regimen, which includes cardiovascular, resistance, and flexibility training. For each exercise training session involving the supervised group, a kinesiologist will provide instructions to participants through live video sessions using a teleconferencing application. On the other hand, the follow-up group will discuss their progress with the kinesiologist every 4 weeks over a teleconferencing video call. Feasibility will be assessed by recruitment, adherence, and completion rates. A cost-effectiveness analysis of both approaches will be computed. Changes in muscle function and cardiopulmonary fitness will be examined between the 2 groups, pre- and postintervention. Results: It is anticipated that the supervised group will have higher adherence and completion rates compared to the follow-up group, which may be associated with greater physiological benefits; however, it may not be as cost-effective compared to the follow-up approach. Conclusions: By determining the most feasible telemedicine approach, this study may serve as a basis for providing increased access to specialized adjunct therapies for individuals with rare disorders. International Registered Report Identifier (IRRID): PRR1-10.2196/40262 %M 37399052 %R 10.2196/40262 %U https://www.researchprotocols.org/2023/1/e40262 %U https://doi.org/10.2196/40262 %U http://www.ncbi.nlm.nih.gov/pubmed/37399052 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46179 %T m-RESIST, a Mobile Therapeutic Intervention for Treatment-Resistant Schizophrenia: Feasibility, Acceptability, and Usability Study %A Grasa,Eva %A Seppälä,Jussi %A Alonso-Solis,Anna %A Haapea,Marianne %A Isohanni,Matti %A Miettunen,Jouko %A Caro Mendivelso,Johanna %A Almazan,Cari %A Rubinstein,Katya %A Caspi,Asaf %A Unoka,Zsolt %A Farkas,Kinga %A Usall,Judith %A Ochoa,Susana %A van der Graaf,Shenja %A Jewell,Charlotte %A Triantafillou,Anna %A Stevens,Matthias %A Reixach,Elisenda %A Berdun,Jesus %A , %A Corripio,Iluminada %+ Mental Health Division, Fundació Althaia, Xarxa Assistencial Universitaria de Manresa, Llatjos St, Manresa, 08243, Spain, 34 93 8742112, aalonso@althaia.cat %K schizophrenia %K treatment-resistant %K digital mental health %K mHealth %K mobile health %K mental health %K mental illness %K mental disorder %K psychosis %K symptom management %K adherence %K acceptability %K usability %K feasibility %K digital intervention %K mobile intervention %K mobile phone %D 2023 %7 30.6.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: In the European Union, around 5 million people are affected by psychotic disorders, and approximately 30%-50% of people with schizophrenia have treatment-resistant schizophrenia (TRS). Mobile health (mHealth) interventions may be effective in preventing relapses, increasing treatment adherence, and managing some of the symptoms of schizophrenia. People with schizophrenia seem willing and able to use smartphones to monitor their symptoms and engage in therapeutic interventions. mHealth studies have been performed with other clinical populations but not in populations with TRS. Objective: The purpose of this study was to present the 3-month prospective results of the m-RESIST intervention. This study aims to assess the feasibility, acceptability, and usability of the m-RESIST intervention and the satisfaction among patients with TRS after using this intervention. Methods: A prospective multicenter feasibility study without a control group was undertaken with patients with TRS. This study was performed at 3 sites: Sant Pau Hospital (Barcelona, Spain), Semmelweis University (Budapest, Hungary), and Sheba Medical Center and Gertner Institute of Epidemiology and Health Policy Research (Ramat-Gan, Israel). The m-RESIST intervention consisted of a smartwatch, a mobile app, a web-based platform, and a tailored therapeutic program. The m-RESIST intervention was delivered to patients with TRS and assisted by mental health care providers (psychiatrists and psychologists). Feasibility, usability, acceptability, and user satisfaction were measured. Results: This study was performed with 39 patients with TRS. The dropout rate was 18% (7/39), the main reasons being as follows: loss to follow-up, clinical worsening, physical discomfort of the smartwatch, and social stigma. Patients’ acceptance of m-RESIST ranged from moderate to high. The m-RESIST intervention could provide better control of the illness and appropriate care, together with offering user-friendly and easy-to-use technology. In terms of user experience, patients indicated that m-RESIST enabled easier and quicker communication with clinicians and made them feel more protected and safer. Patients’ satisfaction was generally good: 78% (25/32) considered the quality of service as good or excellent, 84% (27/32) reported that they would use it again, and 94% (30/32) reported that they were mostly satisfied. Conclusions: The m-RESIST project has provided the basis for a new modular program based on novel technology: the m-RESIST intervention. This program was well-accepted by patients in terms of acceptability, usability, and satisfaction. Our results offer an encouraging starting point regarding mHealth technologies for patients with TRS. Trial Registration: ClinicalTrials.gov NCT03064776; https://clinicaltrials.gov/ct2/show/record/NCT03064776 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2017-021346 %M 37389933 %R 10.2196/46179 %U https://formative.jmir.org/2023/1/e46179 %U https://doi.org/10.2196/46179 %U http://www.ncbi.nlm.nih.gov/pubmed/37389933 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45298 %T Workout Logging Through an mHealth App for Weight Reduction Among Different Generations: Secondary Analysis of the MED PSU×ThaiSook Healthier Challenge %A Sae-lee,Kittiya %A Surangsrirat,Decho %A Parlawong,Chanatip %A Anawilkul,T-touch %A Assawachamrun,Narinuch %A Boonbandan,Pawanya %A Ladapongpuwat,Paweerata %A Chupetch,Bhawat %A Thongchai,Supatcha %A Pruphetkaew,Nannapat %A Thongseiratch,Therdpong %A Vichitkunakorn,Polathep %A Ngamchaliew,Pitchayanont %+ Department of Family and Preventive Medicine, Faculty of Medicine, Prince of Songkla University, 15 Karnchanawanich Road, Hat Yai, Songkhla, 90110, Thailand, 66 74451330, pitchayanont@hotmail.com %K generations %K logging frequency %K mobile health app %K weight status %K weight reduction %D 2023 %7 30.6.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Being overweight or obese presents a major risk factor for noncommunicable diseases (NCDs) such as cardiovascular disease, diabetes, and musculoskeletal disorders. These problems are preventable and solvable via weight reduction and increased physical activity and exercise. The number of adults who are overweight or affected by obesity has tripled in the last 4 decades. Using mobile health (mHealth) apps can help users with health issues, including reducing their weight by restricting their daily calorie intake, which can be recorded along with other parameters, such as physical activity and exercise. These features could further enhance health and prevent NCDs. ThaiSook, a Thai mHealth app developed by the National Science and Technology Development Agency, aims to promote healthy lifestyles and reduce the risk behaviors of NCDs. Objective: This study aimed to determine whether ThaiSook users were successful in 1-month weight reduction and identify which demographic factors or logging functions were associated with significant weight reduction. Methods: A secondary data analysis was performed using data collected from the “MED PSU×ThaiSook Healthier Challenge,” a month-long challenge to encourage a healthy lifestyle. We enrolled 376 participants to evaluate the study outcomes. The variables, comprising demographic characteristics (ie, sex, generation, group size, and BMI), were classified into 4 groups: normal (18.5-22.9 kg/m2), overweight (23-24.9 kg/m2), obese I (25-29.9 kg/m2), and obese II (BMI ≥30 kg/m2). Logging functions (ie, water, fruit and vegetables, sleep, workout, step, and run) were classified into 2 groups: consistent (≥80%) and inconsistent (<80%) users. Weight reduction was categorized into 3 groups: no weight reduction, slight weight reduction (0%-3%), and significant weight reduction (>3%). Results: Of 376 participants, most were female (n=346, 92%), had normal BMI (n=178, 47.3%), belonged to Generation Y (n=147, 46.7%), and had a medium group size (6-10 members; n=250, 66.5%). The results showed that 56 (14.9%) participants had 1-month significant weight loss, and the median weight reduction of the group was −3.85% (IQR −3.40% to −4.50%). Most participants (264/376, 70.2%) experienced weight loss, with an overall median weight loss of −1.08% (IQR −2.40% to 0.00%). The factors associated with significant weight reduction were consistently logging workouts (adjusted odds ratio [AOR] 1.69, 95% CI 1.07-2.68), being Generation Z (AOR 3.06, 95% CI 1.01-9.33), and being overweight or being obese compared to those with normal BMI (AOR 2.66, 95% CI 1.41-5.07; AOR 1.76, 95% CI 1.08-2.87, respectively). Conclusions: More than half of the “MED PSU×ThaiSook Healthier Challenge” participants achieved a slight weight reduction, and 14.9% (56/376) of users lost significant weight. Factors including workout logging, being Generation Z, being overweight, and being obese were associated with significant weight reduction. %M 37389918 %R 10.2196/45298 %U https://formative.jmir.org/2023/1/e45298 %U https://doi.org/10.2196/45298 %U http://www.ncbi.nlm.nih.gov/pubmed/37389918 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44126 %T Barriers to and Facilitators of Using Remote Measurement Technology in the Long-Term Monitoring of Individuals With ADHD: Interview Study %A Denyer,Hayley %A Deng,Qigang %A Adanijo,Abimbola %A Asherson,Philip %A Bilbow,Andrea %A Folarin,Amos %A Groom,Madeleine J %A Hollis,Chris %A Wykes,Til %A Dobson,Richard JB %A Kuntsi,Jonna %A Simblett,Sara %+ Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, United Kingdom, 44 20 7848 5308, hayley.denyer@kcl.ac.uk %K attention-deficit/hyperactivity disorder %K ADHD %K remote measurement technology %K engagement %K barriers and facilitators %K qualitative analysis %K mobile phone %D 2023 %7 30.6.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Remote measurement technology (RMT) has the potential to address current research and clinical challenges of attention-deficit/hyperactivity disorder (ADHD) symptoms and its co-occurring mental health problems. Despite research using RMT already being successfully applied to other populations, adherence and attrition are potential obstacles when applying RMT to a disorder such as ADHD. Hypothetical views and attitudes toward using RMT in a population with ADHD have previously been explored; however, to our knowledge, there is no previous research that has used qualitative methods to understand the barriers to and facilitators of using RMT in individuals with ADHD following participation in a remote monitoring period. Objective: We aimed to evaluate the barriers to and facilitators of using RMT in individuals with ADHD compared with a group of people who did not have a diagnosis of ADHD. We also aimed to explore participants’ views on using RMT for 1 or 2 years in future studies. Methods: In total, 20 individuals with ADHD and 20 individuals without ADHD were followed up for 10 weeks using RMT that involved active (questionnaires and cognitive tasks) and passive (smartphone sensors and wearable devices) monitoring; 10 adolescents and adults with ADHD and 12 individuals in a comparison group completed semistructured qualitative interviews at the end of the study period. The interviews focused on potential barriers to and facilitators of using RMT in adults with ADHD. A framework methodology was used to explore the data qualitatively. Results: Barriers to and facilitators of using RMT were categorized as health-related, user-related, and technology-related factors across both participant groups. When comparing themes that emerged across the participant groups, both individuals with and without ADHD experienced similar barriers and facilitators in using RMT. The participants agreed that RMT can provide useful objective data. However, slight differences between the participant groups were identified as barriers to RMT across all major themes. Individuals with ADHD described the impact that their ADHD symptoms had on participating (health-related theme), commented on the perceived cost of completing the cognitive tasks (user-related theme), and described more technical challenges (technology-related theme) than individuals without ADHD. Hypothetical views on future studies using RMT in individuals with ADHD for 1 or 2 years were positive. Conclusions: Individuals with ADHD agreed that RMT, which uses repeated measurements with ongoing active and passive monitoring, can provide useful objective data. Although themes overlapped with previous research on barriers to and facilitators of engagement with RMT (eg, depression and epilepsy) and with a comparison group, there are unique considerations for people with ADHD, for example, understanding the impact that ADHD symptoms may have on engaging with RMT. Researchers need to continue working with people with ADHD to develop future RMT studies for longer periods. %M 37389932 %R 10.2196/44126 %U https://formative.jmir.org/2023/1/e44126 %U https://doi.org/10.2196/44126 %U http://www.ncbi.nlm.nih.gov/pubmed/37389932 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48447 %T Evaluating an Innovative HIV Self-Testing Service With Web-Based, Real-Time Counseling Provided by an Artificial Intelligence Chatbot (HIVST-Chatbot) in Increasing HIV Self-Testing Use Among Chinese Men Who Have Sex With Men: Protocol for a Noninferiority Randomized Controlled Trial %A Chen,Siyu %A Zhang,Qingpeng %A Chan,Chee-kit %A Yu,Fuk-yuen %A Chidgey,Andrew %A Fang,Yuan %A Mo,Phoenix K H %A Wang,Zixin %+ Centre for Health Behaviours Research, Jockey Club School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong, Room 508, School of Public Health, Prince of Wales Hospital, Shatin, N.T., Hong Kong, 999077, Hong Kong, 852 2252 8740, wangzx@cuhk.edu.hk %K Chatbot %K counseling %K HIV self-testing %K men who have sex with men %K non-inferiority randomized controlled trial %D 2023 %7 30.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Counseling support for HIV self-testing (HIVST) users is essential to ensure support and linkage to care among men who have sex with men (MSM). An HIVST service with web-based real-time instruction, pretest, and posttest counseling provided by trained administrators (HIVST-OIC) was developed by previous projects. Although the HIVST-OIC was highly effective in increasing HIVST uptake and the proportion of HIVST users receiving counseling along with testing, it required intensive resources to implement and sustain. The service capacity of HIVST-OIC cannot meet the increasing demands of HIVST. Objective: This randomized controlled trial primarily aims to establish whether HIVST-chatbot, an innovative HIVST service with web-based real-time instruction and counseling provided by a fully automated chatbot, would produce effects that are similar to HIVST-OIC in increasing HIVST uptake and the proportion of HIVST users receiving counseling alongside testing among MSM within a 6-month follow-up period. Methods: A parallel-group, noninferiority randomized controlled trial will be conducted with Chinese-speaking MSM aged ≥18 years with access to live-chat applications. A total of 528 participants will be recruited through multiple sources, including outreach in gay venues, web-based advertisement, and peer referral. After completing the baseline telephone survey, participants will be randomized evenly into the intervention or control groups. Intervention group participants will watch a web-based video promoting HIVST-chatbot and receive a free HIVST kit. The chatbot will contact the participant to implement HIVST and provide standard-of-care, real-time pretest and posttest counseling and instructions on how to use the HIVST kit through WhatsApp. Control group participants will watch a web-based video promoting HIVST-OIC and receive a free HIVST kit in the same manner. Upon appointment, a trained testing administrator will implement HIVST and provide standard-of-care, real-time pretest and posttest counseling and instructions on how to use the HIVST kit through live-chat applications. All participants will complete a telephone follow-up survey 6 months after the baseline. The primary outcomes are HIVST uptake and the proportion of HIVST users receiving counseling support along with testing in the past 6 months, measured at month 6. Secondary outcomes include sexual risk behaviors and uptake of HIV testing other than HIVST during the follow-up period. Intention-to-treat analysis will be used. Results: Recruitment and enrollment of participants started in April 2023. Conclusions: This study will generate important research and policy implications regarding chatbot use in HIVST services. If HIVST-chatbot is proven noninferior to HIVST-OIC, it can be easily integrated into existing HIVST services in Hong Kong, given its relatively low resource requirements for implementation and maintenance. HIVST-chatbot can potentially overcome the barriers to using HIVST. Therefore, the coverage of HIV testing, the level of support, and the linkage to care for MSM HIVST users will be increased. Trial Registration: ClinicalTrial.gov NCT05796622; https://clinicaltrials.gov/ct2/show/NCT05796622 International Registered Report Identifier (IRRID): PRR1-10.2196/48447 %M 37389935 %R 10.2196/48447 %U https://www.researchprotocols.org/2023/1/e48447 %U https://doi.org/10.2196/48447 %U http://www.ncbi.nlm.nih.gov/pubmed/37389935 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46052 %T Comparing Message-Based Psychotherapy to Once-Weekly, Video-Based Psychotherapy for Moderate Depression: Randomized Controlled Trial %A Song,Jiyoung %A Litvin,Boris %A Allred,Ryan %A Chen,Shiyu %A Hull,Thomas D %A Areán,Patricia A %+ Department of Psychology, University of California, Berkeley, 2121 Berkeley Way, Berkeley, CA, 94720, United States, 1 9493794232, jiyoungsong@berkeley.edu %K randomized controlled trial %K message-based psychotherapy %K video-based psychotherapy %K telemedicine %K depression %K anxiety %K functional impairment, credibility, alliance, engagement %K mental health %K text mining %K message therapy %K Burden of Disease %K telehealth %K intervention %D 2023 %7 29.6.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite the high prevalence of major depressive disorder and the related societal burden, access to effective traditional face-to-face or video-based psychotherapy is a challenge. An alternative that offers mental health care in a flexible setting is asynchronous messaging therapy. To date, no study has evaluated its efficacy and acceptability in a randomized controlled trial for depression. Objective: The aim of this study was to compare the efficacy and acceptability of message-based psychotherapy for depression to once-weekly video-based psychotherapy. Methods: In this 2-armed randomized controlled trial, individuals (N=83) with depressive symptomatology (Patient Health Questionnaire-9 ≥10) were recruited on the internet and randomly assigned to either a message-based intervention group (n=46) or a once-weekly video-based intervention group (n=37). Patients in the message-based treatment condition exchanged asynchronous messages with their therapist following an agreed-upon schedule. Patients in the video-based treatment condition met with their therapist once each week for a 45-minute video teletherapy session. Self-report data for depression, anxiety, and functional impairment were collected at pretreatment, weekly during treatment, at posttreatment, and at a 6-month follow-up. Self-reported treatment expectancy and credibility for the assigned intervention were assessed at pretreatment and therapeutic alliance at posttreatment. Results: Findings from multilevel modeling indicated significant, medium-to-large improvements in depression (d=1.04; 95% CI 0.60-1.46), anxiety (d=0.61; 95% CI 0.22-0.99), and functional impairment (d=0.66; 95% CI 0.27-1.05) for patients in the message-based treatment condition. Changes in depression (d=0.11; 95% CI –0.43 to 0.66), anxiety (d=–0.01; 95% CI –0.56 to 0.53), and functional impairment (d=0.25; 95% CI –0.30 to 0.80) in the message-based treatment condition were noninferior to those in the video-based treatment condition. There were no significant differences in treatment credibility (d=–0.09; 95% CI –0.64 to 0.45), therapeutic alliance (d=–0.15; 95% CI –0.75 to 0.44), or engagement (d=0.24; 95% CI –0.20 to 0.67) between the 2 treatment conditions. Conclusions: Message-based psychotherapy could present an effective and accessible alternative treatment modality for patients who might not be able to engage in traditional scheduled services such as face-to-face or video-based psychotherapy. Trial Registration: ClinicalTrials.gov NCT05467787; https://www.clinicaltrials.gov/ct2/show/NCT05467787 %M 37384392 %R 10.2196/46052 %U https://www.jmir.org/2023/1/e46052 %U https://doi.org/10.2196/46052 %U http://www.ncbi.nlm.nih.gov/pubmed/37384392 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e41490 %T Digital Action Plan (Web App) for Managing Asthma Exacerbations: Randomized Controlled Trial %A Beydon,Nicole %A Taillé,Camille %A Corvol,Harriet %A Valcke,Judith %A Portal,Jean-Jacques %A Plantier,Laurent %A Mangiapan,Gilles %A Perisson,Caroline %A Aubertin,Guillaume %A Hadchouel,Alice %A Briend,Guillaume %A Guilleminault,Laurent %A Neukirch,Catherine %A Cros,Pierrick %A Appere de Vecchi,Corinne %A Mahut,Bruno %A Vicaut,Eric %A Delclaux,Christophe %+ Service de Physiologie Pédiatrique-Centre du Sommeil, Hôpital Robert Debré, Assistance Publique Hôpitaux de Paris, Institut National de la Santé et de la Recherche Médicale NeuroDiderot, Université de Paris Cité, F-75019, 48 boulevard Serurier, Paris, 75019, France, 33 140034190, christophe.delclaux@aphp.fr %K asthma exacerbation %K action plan %K web application %K mobile phone %D 2023 %7 29.6.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: A written action plan (WAP) for managing asthma exacerbations is recommended. Objective: We aimed to compare the effect on unscheduled medical contacts (UMCs) of a digital action plan (DAP) accessed via a smartphone web app combined with a WAP on paper versus that of the same WAP alone. Methods: This randomized, unblinded, multicenter (offline recruitment in private offices and public hospitals), and parallel-group trial included children (aged 6-12 years) or adults (aged 18-60 years) with asthma who had experienced at least 1 severe exacerbation in the previous year. They were randomized to a WAP or DAP+WAP group in a 1:1 ratio. The DAP (fully automated) provided treatment advice according to the severity and previous pharmacotherapy of the exacerbation. The DAP was an algorithm that recorded 3 to 9 clinical descriptors. In the app, the participant first assessed the severity of their current symptoms on a 10-point scale and then entered the symptom descriptors. Before the trial, the wordings and ordering of these descriptors were validated by 50 parents of children with asthma and 50 adults with asthma; the app was not modified during the trial. Participants were interviewed at 3, 6, 9, and 12 months to record exacerbations, UMCs, and WAP and DAP use, including the subjective evaluation (availability and usefulness) of the action plans, by a research nurse. Results: Overall, 280 participants were randomized, of whom 33 (11.8%) were excluded because of the absence of follow-up data after randomization, leaving 247 (88.2%) participants (children: n=93, 37.7%; adults: n=154, 62.3%). The WAP group had 49.8% (123/247) of participants (children: n=45, 36.6%; mean age 8.3, SD 2.0 years; adults: n=78, 63.4%; mean age 36.3, SD 12.7 years), and the DAP+WAP group had 50.2% (124/247) of participants (children: n=48, 38.7%; mean age 9.0, SD 1.9 years; adults: n=76, 61.3%; mean age 34.5, SD 11.3 years). Overall, the annual severe exacerbation rate was 0.53 and not different between the 2 groups of participants. The mean number of UMCs per year was 0.31 (SD 0.62) in the WAP group and 0.37 (SD 0.82) in the DAP+WAP group (mean difference 0.06, 95% CI −0.12 to 0.24; P=.82). Use per patient with at least 1 moderate or severe exacerbation was higher for the WAP (33/65, 51% vs 15/63, 24% for the DAP; P=.002). Thus, participants were more likely to use the WAP than the DAP despite the nonsignificant difference between the action plans in the subjective evaluation. Median symptom severity of the self-evaluated exacerbation was 4 out of 10 and not significantly different from the symptom severity assessed by the app. Conclusions: The DAP was used less often than the WAP and did not decrease the number of UMCs compared with the WAP alone. Trial Registration: ClinicalTrials.gov NCT02869958; https://clinicaltrials.gov/ct2/show/NCT02869958 %M 37255277 %R 10.2196/41490 %U https://www.jmir.org/2023/1/e41490 %U https://doi.org/10.2196/41490 %U http://www.ncbi.nlm.nih.gov/pubmed/37255277 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48923 %T Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People With HIV (Project EndIT): Protocol for a Randomized Controlled Trial %A Bui,Thanh Cong %A Hoogland,Charles E %A Chhea,Chhorvann %A Sopheab,Heng %A Ouk,Vichea %A Samreth,Sovannarith %A Hor,Bunleng %A Vidrine,Jennifer I %A Businelle,Michael S %A Shih,Ya Chen Tina %A Sutton,Steven K %A Jones,Sarah R %A Shorey Fennell,Bethany %A Cottrell-Daniels,Cherell %A Frank-Pearce,Summer G %A Ngor,Chamnab %A Kulkarni,Shweta %A Vidrine,Damon J %+ TSET Health Promotion Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, 655 Research Parkway Suite 400, Oklahoma City, OK, 73104, United States, 1 405 271 8001 ext 50559, thanh-c-bui@ouhsc.edu %K smoking cessation %K HIV/AIDS %K cost-effectiveness %K low- and middle-income countries %K Cambodia %K Phase-Based Model %K RCT %K randomized controlled trial %K mHealth %D 2023 %7 29.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: The prevalence of smoking remains high in many low- and middle-income countries (LMICs), including the Southeast Asian nation of Cambodia. Smoking is especially hazardous for people with HIV. In Cambodia, approximately 43%-65% of men with HIV and 3%-5% of women with HIV smoke cigarettes. Thus, there is a critical need for cost-effective smoking cessation interventions for Cambodian people with HIV. This paper describes the design, methods, and data analysis plans for a randomized controlled trial assessing the efficacy of a theory-based mobile health smoking cessation intervention in Cambodian people with HIV. Objective: This 2-group randomized controlled trial compares the efficacy of a mobile health–based automated messaging (AM) intervention versus standard care (SC) in facilitating smoking cessation among Cambodian people with HIV. Methods: Cambodian people with HIV who currently smoke and are receiving antiretroviral treatment (target, N=800) will be randomized to (1) SC or (2) the AM intervention. SC participants will receive brief advice to quit smoking, written self-help materials, nicotine patches, and will complete weekly app-delivered dietary assessments for 26 weeks. AM participants will receive all SC components (but will complete smoking-related weekly assessments instead of dietary assessments), in addition to a fully automated tailored messaging program driven by the weekly assessments to facilitate smoking cessation. In the Phase-Based Model of smoking cessation, the cessation process is partitioned into 4 phases: motivation, preparation (precessation), cessation (quit date to 2 weeks post quit), and maintenance (up to 6 months post quit). Our AM program targets processes within these phases, including increasing motivation to quit, enhancing self-efficacy, obtaining social support, skills to cope with nicotine withdrawal symptoms and stress, and skills to maintain abstinence. All participants will complete baseline and 3-, 6-, and 12-month in-person follow-up assessments. The primary outcome is biochemically confirmed abstinence at 12 months, with 3- and 6-month abstinence as secondary outcomes. Potential mediators and moderators underlying treatment effects will be explored, and cost-effectiveness will be assessed. Results: This study was approved by all relevant domestic and international institutional and ethical review boards. Participant recruitment commenced in January 2023. Data collection is expected to conclude by the end of 2025. Conclusions: By demonstrating the greater efficacy and cost-effectiveness of AM relative to SC, this study has the potential to transform HIV care in Cambodia and prevent tobacco-related diseases. Furthermore, it may be adapted for use in other Cambodian populations and in other low- and middle-income countries. Ultimately, the AM approach to smoking cessation could greatly improve public health in the developing world and beyond. Trial Registration: ClinicalTrials.gov NCT05746442; https://clinicaltrials.gov/ct2/show/NCT05746442 International Registered Report Identifier (IRRID): PRR1-10.2196/48923 %M 37384390 %R 10.2196/48923 %U https://www.researchprotocols.org/2023/1/e48923 %U https://doi.org/10.2196/48923 %U http://www.ncbi.nlm.nih.gov/pubmed/37384390 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e48166 %T Effectiveness of Digital Health Literacy Interventions in Older Adults: Single-Arm Meta-Analysis %A Dong,Qian %A Liu,Ting %A Liu,Ran %A Yang,Hongxia %A Liu,Cuiping %+ School of Nursing, Shandong First Medical University & Shandong Academy of Medical Sciences, No.619 Changcheng Road, Taian, Shandong Province, 271016, China, 86 13854218960, lcping0926@126.com %K digital health literacy interventions %K older adults %K eHealth literacy efficacy %K knowledge %K self-efficacy %K skills %D 2023 %7 28.6.2023 %9 Review %J J Med Internet Res %G English %X Background: In a world of rapid digital technology development, the lack of digital health literacy (DHL) among older people cannot be ignored. DHL is becoming an essential competency that can facilitate the health status and health management of older adults. DHL interventions that are feasible and appropriate can be implemented on a large scale through the health care system for older people. Objective: The purpose of this meta-analysis was to assess the effectiveness of DHL interventions for older adults. Methods: English publications in PubMed, Web of Science, Embase, and the Cochrane Library were searched from inception to November 20, 2022. Two reviewers independently completed the data extraction and quality assessment. Review Manager (version 5.4; Cochrane Informatics & Technology Services) software was used for all meta-analyses. Results: A total of 7 studies, including 2 randomized controlled trials and 5 quasi-experimental studies, involving 710 older adults were considered eligible. The main outcome was scores on the eHealth Literacy Scale, and secondary outcomes were knowledge, self-efficacy, and skills. Quasi-experimental studies compared baseline and postintervention outcomes, while randomized controlled trials compared pre- and postintervention outcomes in the intervention group. Of the 7 studies, 3 used face-to-face instruction, while 4 adopted web-based interventions. Among them, 4 of the interventions were conducted using theoretical guidance, while 3 were not. Intervention duration varied from 2 to 8 weeks. In addition, the studies included were all conducted in developed countries, mainly in the United States. Pooled analysis presented that DHL interventions had positive effects on eHealth literacy efficacy (standardized mean difference 1.15, 95% CI 0.46 to 1.84; P=.001). Subgroup analysis revealed that DHL interventions that chose face-to-face teaching (standardized mean difference 1.15, 95% CI 0.46 to 1.84; P=.001), were guided by a conceptual framework (standardized mean difference 1.15, 95% CI 0.46 to 1.84; P=.001), and were sustained over 4 weeks (standardized mean difference 1.1, 95% CI 0.46 to 1.84; P=.001) had a more significant effect. Moreover, the outcomes showed considerable gains in knowledge (standardized mean difference 0.93, 95% CI 0.54 to 1.31; P<.001) and self-efficacy (standardized mean difference 0.96, 95% CI 0.16 to 1.77; P=.02). No statistically significant effect was found for skills (standardized mean difference 0.77, 95% CI –0.30 to 1.85; P=.16). The small number of studies, variable study quality, and heterogeneity are some limitations of this review. Conclusions: DHL interventions have positive effects on the health status and health management of older adults. Practical and effective DHL interventions are crucial for the use of modern digital information technology in managing the health of older people. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42023410204; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=410204 %M 37379077 %R 10.2196/48166 %U https://www.jmir.org/2023/1/e48166 %U https://doi.org/10.2196/48166 %U http://www.ncbi.nlm.nih.gov/pubmed/37379077 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e47869 %T Pain Reduction With an Immersive Digital Therapeutic in Women Living With Endometriosis-Related Pelvic Pain: At-Home Self-Administered Randomized Controlled Trial %A Merlot,Benjamin %A Elie,Valéry %A Périgord,Adrien %A Husson,Zoé %A Jubert,Amandine %A Chanavaz-Lacheray,Isabella %A Dennis,Thomas %A Cotty-Eslous,Maryne %A Roman,Horace %+ Lucine, 223 rue Emile Counord, Bordeaux, 33300, France, 33 636226605, valery.elie@lucine.care %K randomized controlled trial %K virtual reality %K digital therapeutics %K digital health %K endometriosis %K chronic pain %K pelvic pain %K women's health %K digital health intervention %K patient outcome %D 2023 %7 28.6.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: The management of chronic pelvic pain in women with endometriosis is complex and includes the long-term use of opioids. Patients not fully responsive to drugs or ineligible for surgical treatments need efficient alternatives to improve their quality of life and avoid long-term sequelae. Objective: This randomized controlled trial aimed to assess the effects of repeated at-home administrations of a 20-minute virtual reality (VR) solution (Endocare) compared with a sham condition on pain in women experiencing pelvic pain due to endometriosis. Methods: Patients were instructed to use the VR headsets twice daily for at least 2 days and for up to 5 days starting on their first day of painful periods. Pain perception was measured using a numerical scale (0-10) before and 60, 120, and 180 minutes after each treatment administration. General pain, stress, fatigue, medication intake, and quality of life were reported daily by patients. Results: A total of 102 patients with endometriosis were included in the final analysis (Endocare group: n=51, 50%; sham group: n=51, 50%). The mean age was 32.88 years (SD 6.96) and the mean pain intensity before treatment was 6.53 (SD 1.74) and 6.22 (SD 1.69) for the Endocare group and the sham control group, respectively (P=.48). Pain intensity decreased in both groups from day 1 to day 5 along with a decrease in medication use. Maximum pain intensity reduction of 51.58% (SD 35.33) occurred at day 2, 120 minutes after treatment for the Endocare group and of 27.37% (SD 27.23) at day 3, 180 minutes after treatment for the control group. Endocare was significantly superior to the sham on day 1 (120 minutes, P=.04; 180 minutes, P=.001), day 2 (0 minutes, P=.02; 60, 120, and 180 minutes, all P<.001), and day 3 (60 minutes, P=.01; 120 minutes, P=.005; 180 minutes, P=.001). Similarly, the mean perceived pain relief was significantly higher with Endocare on day 1 (120 and 180 minutes P=.004 and P=.001, respectively) and day 2 (60, 120, and 180 minutes P=.003, P=.004, and P=.007, respectively) compared to the control. No adverse event was reported. Conclusions: This study confirmed the effectiveness and safety of self-repeated administrations of a VR immersive treatment used at home while reducing overall pain medication intake in women diagnosed with endometriosis experiencing moderate-to-severe pelvic pain. Trial Registration: ClinicalTrials.gov NCT05172492; https://clinicaltrials.gov/ct2/show/NCT05172492 %M 37260160 %R 10.2196/47869 %U https://www.jmir.org/2023/1/e47869 %U https://doi.org/10.2196/47869 %U http://www.ncbi.nlm.nih.gov/pubmed/37260160 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e46155 %T Feasibility, Acceptability, and Potential Impact of a Novel mHealth App for Smokers Ambivalent About Quitting: Randomized Pilot Study %A McClure,Jennifer B %A Heffner,Jaimee L %A Krakauer,Chloe %A Mun,Sophia %A Klasnja,Predrag %A Catz,Sheryl L %+ Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA, 98101, United States, 1 206 287 2737, Jennifer.B.McClure@kp.org %K ambivalence %K app %K digital health intervention %K mHealth intervention %K mHealth %K motivation %K nicotine %K smoking %K smoking cessation %K tobacco %D 2023 %7 28.6.2023 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Most smokers are ambivalent about quitting—they want to quit someday, but not now. Interventions are needed that can engage ambivalent smokers, build their motivation for quitting, and support future quit attempts. Mobile health (mHealth) apps offer a cost-effective platform for such interventions, but research is needed to inform their optimal design and assess their acceptability, feasibility, and potential effectiveness. Objective: This study aims to assess the feasibility, acceptability, and potential impact of a novel mHealth app for smokers who want to quit smoking someday but are ambivalent about quitting in the near term. Methods: We enrolled adults across the United States who smoked more than 10 cigarettes a day and were ambivalent about quitting (n=60). Participants were randomly assigned to 1 of 2 versions of the GEMS app: standard care (SC) versus enhanced care (EC). Both had a similar design and identical evidence-based, best-practice smoking cessation advice and resources, including the ability to earn free nicotine patches. EC also included a series of exercises called experiments designed to help ambivalent smokers clarify their goals, strengthen their motivation, and learn important behavioral skills for changing smoking behavior without making a commitment to quit. Outcomes were analyzed using automated app data and self-reported surveys at 1 and 3 months post enrollment. Results: Participants who installed the app (57/60, 95%) were largely female, White, socioeconomically disadvantaged, and highly nicotine dependent. As expected, key outcomes trended in favor of the EC group. Compared to SC users, EC participants had greater engagement (mean sessions 19.9 for EC vs 7.3 for SC). An intentional quit attempt was reported by 39.3% (11/28) of EC users and 37.9% (11/29) of SC users. Seven-day point prevalence smoking abstinence at the 3-month follow-up was reported by 14.7% (4/28) of EC users and 6.9% (2/29) of SC users. Among participants who earned a free trial of nicotine replacement therapy based on their app usage, 36.4% (8/22) of EC participants and 11.1% (2/18) of SC participants requested the treatment. A total of 17.9% (5/28) of EC and 3.4% (1/29) of SC participants used an in-app feature to access a free tobacco quitline. Other metrics were also promising. EC participants completed an average of 6.9 (SD 3.1) out of 9 experiments. Median helpfulness ratings for completed experiments ranged from 3 to 4 on a 5-point scale. Finally, satisfaction with both app versions was very good (mean 4.1 on a 5-point Likert scale) and 95.3% (41/43) of all respondents would recommend their app version to others. Conclusions: Ambivalent smokers were receptive to the app-based intervention, but the EC version, which combined best-practice cessation advice with self-paced, experiential exercises, was associated with greater use and evidence of behavior change. Further development and evaluation of the EC program is warranted. Trial Registration: ClinicalTrials.gov NCT04560868; https://clinicaltrials.gov/ct2/show/NCT04560868 %M 37379059 %R 10.2196/46155 %U https://mhealth.jmir.org/2023/1/e46155 %U https://doi.org/10.2196/46155 %U http://www.ncbi.nlm.nih.gov/pubmed/37379059 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48499 %T A Web-Based Dyadic Intervention to Manage Psychoneurological Symptoms for Patients With Colorectal Cancer and Their Caregivers: Protocol for a Mixed Methods Study %A Lin,Yufen %A Porter,Laura S %A Chee,Wonshik %A Alese,Olatunji B %A Curseen,Kimberly A %A Higgins,Melinda K %A Northouse,Laurel %A Xiao,Canhua %+ Nell Hodgson Woodruff School of Nursing, Emory University, 1520 Clifton Road NE, Atlanta, GA, 30322, United States, 1 4042514072, yufen.lin@emory.edu %K chemotherapy %K colorectal cancer %K intervention %K symptoms %K web-based program %D 2023 %7 28.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Patients with colorectal cancer (CRC) receiving chemotherapy often experience psychoneurological symptoms (PNS; ie, fatigue, depression, anxiety, sleep disturbance, pain, and cognitive dysfunction) that negatively impact both patients’ and their caregivers’ health outcomes. Limited information is available on PNS management for CRC patient and caregiver dyads. Objective: The purposes of this study are to (1) develop a web-based dyadic intervention for patients with CRC receiving chemotherapy and their caregivers (CRCweb) and (2) evaluate the feasibility, acceptability, and preliminary effects of CRCweb among patient-caregiver dyads in a cancer clinic. Methods: A mixed methods approach will be used. Semistructured interviews among 8 dyads will be conducted to develop CRCweb. A single-group pre- and posttest clinical trial will be used to examine the feasibility, acceptability, and preliminary effects of the intervention (CRCweb) among 20 dyads. Study assessments will be conducted before (T1) and after intervention (T2). Content analysis will be performed for semistructured interviews. Descriptive statistics will be calculated separately for patients and caregivers, and pre-post paired t tests will be used to evaluate treatment effects. Results: This study was funded in November 2022. As of April 2023, we have obtained institutional review board approval and completed clinical trial registration and are currently recruiting patient-caregiver dyads in a cancer clinic. The study is expected to be completed in October 2024. Conclusions: Developing a web-based dyadic intervention holds great promise to reduce the PNS burden in patients with CRC receiving chemotherapy and their caregivers. The findings from this study will advance intervention development and implementation of symptom management and palliative care for patients with cancer and their caregivers. Trial Registration: ClinicalTrials.gov NCT05663203; https://clinicaltrials.gov/ct2/show/NCT05663203 International Registered Report Identifier (IRRID): PRR1-10.2196/48499 %M 37379055 %R 10.2196/48499 %U https://www.researchprotocols.org/2023/1/e48499 %U https://doi.org/10.2196/48499 %U http://www.ncbi.nlm.nih.gov/pubmed/37379055 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43528 %T Effect of a Mobile App–Based Urinary Incontinence Self-Management Intervention Among Pregnant Women in China: Pragmatic Randomized Controlled Trial %A Chen,Ling %A Zhang,Danli %A Li,Tiantian %A Liu,Sha %A Hua,Jie %A Cai,Wenzhi %+ Department of Nursing, Shenzhen Hospital, Southern Medical University, Number 1333, Xinhu Road, Baoán District Shenzhen, Guangdong, Shenzhen, 518101, China, 86 13078484316, caiwzh@smu.edu.cn %K mobile health %K mHealth %K mobile apps %K urinary incontinence %K pregnancy %K pragmatic randomized controlled trial %K mobile phone %D 2023 %7 27.6.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Urinary incontinence (UI) is a highly prevalent health concern commonly observed during and after pregnancy that can substantially impact women’s physical and psychological well-being and quality of life. Owing to its numerous advantages, mobile health may be a promising solution; however, it is unclear whether the app-based intervention can effectively improve UI symptoms during and after pregnancy. Objective: This study aimed to evaluate the effectiveness of the Urinary Incontinence for Women (UIW) app–based intervention for UI symptom improvement among pregnant women in China. Methods: Singleton pregnant women without incontinence before pregnancy who were aged ≥18 years and between 24 and 28 weeks of gestation were recruited from a tertiary public hospital in China and were randomly allocated (1:1) to either an experimental group (n=63) or a control group (n=63). The experimental group received the UIW app intervention and oral pelvic floor muscle training (PFMT) instructions, whereas the control group received oral PFMT instructions alone. Neither the participants nor the researchers were blinded to the intervention. The primary outcome was UI severity. The secondary outcomes included quality of life, self-efficacy with PFMT, and knowledge of UI. All data were collected at baseline, 2 months after randomization, and 6 weeks post partum through electronic questionnaires or by checking the electronic medical record system. Data analysis followed the intention-to-treat principle. A linear mixed model was used to examine the intervention effect on primary and secondary outcomes. Results: Participants in the experimental and control groups were comparable at baseline. Of the 126 overall participants, 117 (92.9%) and 103 (81.7%) women completed follow-up visits at 2 months after randomization and 6 weeks after delivery, respectively. A statistically significant difference in UI symptom severity was observed between the experimental group and control group (2 months after randomization: mean difference −2.86, 95% CI −4.09 to −1.64, P<.001; 6 weeks post partum: mean difference −2.68, 95% CI −3.87 to −1.49, P<.001). For the secondary outcomes, a statistically significant intervention effect on the quality of life, self-efficacy, and UI knowledge was found at the 2-month follow-up (all P<.05) and 6 weeks post partum (all P<.001). Conclusions: The app-based UI self-management intervention (UIW) effectively improved UI symptom severity, quality of life, self-efficacy with PFMT, and knowledge of UI during the late pregnancy and early postnatal periods. Larger multicenter studies with a longer postpartum follow-up are required to further extend these findings. Trial Registration: Chinese Clinical Trial Registry ChiCTR1800016171; http://www.chictr.org.cn/showproj.aspx?proj=27455 International Registered Report Identifier (IRRID): RR2-10.2196/22771 %M 37368465 %R 10.2196/43528 %U https://www.jmir.org/2023/1/e43528 %U https://doi.org/10.2196/43528 %U http://www.ncbi.nlm.nih.gov/pubmed/37368465 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43426 %T Effects of a Web-Based Lifestyle Intervention on Weight Loss and Cardiometabolic Risk Factors in Adults With Overweight and Obesity: Randomized Controlled Clinical Trial %A Kohl,Jan %A Brame,Judith %A Centner,Christoph %A Wurst,Ramona %A Fuchs,Reinhard %A Sehlbrede,Matthias %A Tinsel,Iris %A Maiwald,Phillip %A Fichtner,Urs Alexander %A Armbruster,Christoph %A Farin-Glattacker,Erik %A Gollhofer,Albert %A König,Daniel %+ Department of Sport and Sport Science, University of Freiburg, Schwarzwaldstraße 175, Freiburg, 79117, Germany, 49 76120354087, jan.kohl@sport.uni-freiburg.de %K web-based intervention %K randomized controlled trial %K dietary energy density %K weight loss, obesity %K overweight %K cardiometabolic risk factors %D 2023 %7 27.6.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: The high proportion of people with overweight and obesity has become a worldwide problem in recent decades, mainly due to health consequences, such as cardiovascular diseases, neoplasia, and type 2 diabetes mellitus. Regarding effective countermeasures, the digitization of health services offers numerous potentials, which, however, have not yet been sufficiently evaluated. Web-based health programs are becoming increasingly interactive and can provide individuals with effective long-term weight management support. Objective: The purpose of this randomized controlled clinical trial was to evaluate the effectiveness of an interactive web-based weight loss program on anthropometric, cardiometabolic, and behavioral variables and to compare it with a noninteractive web-based weight loss program. Methods: The randomized controlled trial included people who were aged between 18 and 65 years (mean 48.92, SD 11.17 years) and had a BMI of 27.5 to 34.9 kg/m2 (mean 30.71, SD 2.13 kg/m2). Participants (n=153) were assigned to either (1) an interactive and fully automated web-based health program (intervention) or (2) a noninteractive web-based health program (control). The intervention program focused on dietary energy density and allowed for dietary documentation with appropriate feedback on energy density and nutrients. The control group only received information on weight loss and energy density, but the website did not contain interactive content. Examinations were performed at baseline (t0), at the end of the 12-week intervention (t1), and at 6 months (t2) and 12 months (t3) thereafter. The primary outcome was body weight. The secondary outcomes were cardiometabolic variables as well as dietary and physical activity behaviors. Robust linear mixed models were used to evaluate the primary and secondary outcomes. Results: The intervention group showed significant improvements in anthropometric variables, such as body weight (P=.004), waist circumference (P=.002), and fat mass (P=.02), compared with the control group over the course of the study. The mean weight loss after the 12-month follow-up was 4.18 kg (4.7%) in the intervention group versus 1.29 kg (1.5%) in the control group compared with the initial weight. The results of the nutritional analysis showed that the energy density concept was significantly better implemented in the intervention group. Significant differences in cardiometabolic variables were not detected between the 2 groups. Conclusions: The interactive web-based health program was effective in reducing body weight and improving body composition in adults with overweight and obesity. However, these improvements were not associated with relevant changes in cardiometabolic variables, although it should be noted that the study population was predominantly metabolically healthy. Trial Registration: German Clinical Trials Register DRKS00020249; https://drks.de/search/en/trial/DRKS00020249 International Registered Report Identifier (IRRID): RR2-10.3390/ijerph19031393 %M 37368484 %R 10.2196/43426 %U https://www.jmir.org/2023/1/e43426 %U https://doi.org/10.2196/43426 %U http://www.ncbi.nlm.nih.gov/pubmed/37368484 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42641 %T Effectiveness of the SAFE eHealth Intervention for Women Experiencing Intimate Partner Violence and Abuse: Randomized Controlled Trial, Quantitative Process Evaluation, and Open Feasibility Study %A van Gelder,Nicole E %A Ligthart,Suzanne A %A van Rosmalen-Nooijens,Karin AWL %A Prins,Judith B %A Oertelt-Prigione,Sabine %+ Department of Primary and Community Care, Research Institute for Medical Innovation, Radboud University Medical Center, Geert Grooteplein 21 – route 117, Nijmegen, 6525 EZ, Netherlands, 31 243618181, nicole.vangelder@radboudumc.nl %K domestic violence and abuse %K eHealth %K feasibility %K help seeking %K intimate partner violence and abuse %K mental health %K randomized controlled trial %K self-efficacy %K web based %K web-based intervention %D 2023 %7 27.6.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Intimate partner violence and abuse (IPVA) is a pervasive societal issue that impacts many women globally. Web-based help options are becoming increasingly available and have the ability to eliminate certain barriers in help seeking for IPVA, especially in improving accessibility. Objective: This study focused on the quantitative evaluation of the SAFE eHealth intervention for women IPVA survivors. Methods: A total of 198 women who experienced IPVA participated in a randomized controlled trial and quantitative process evaluation. Participants were largely recruited on the internet and signed up through self-referral. They were allocated (blinded for the participants) to (1) the intervention group (N=99) with access to a complete version of a help website containing 4 modules on IPVA, support options, mental health, and social support, and with interactive components such as a chat, or (2) the limited-intervention control group (N=99). Data were gathered about self-efficacy, depression, anxiety, and multiple feasibility aspects. The primary outcome was self-efficacy at 6 months. The process evaluation focused on themes, such as ease of use and feeling helped. In an open feasibility study (OFS; N=170), we assessed demand, implementation, and practicality. All data for this study were collected through web-based self-report questionnaires and automatically registered web-based data such as page visits and amount of logins. Results: We found no significant difference over time between groups for self-efficacy, depression, anxiety, fear of partner, awareness, and perceived support. However, both study arms showed significantly decreased scores for anxiety and fear of partner. Most participants in both groups were satisfied, but the intervention group showed significantly higher scores for suitability and feeling helped. However, we encountered high attrition for the follow-up surveys. Furthermore, the intervention was positively evaluated on multiple feasibility aspects. The average amount of logins did not significantly differ between the study arms, but participants in the intervention arm did spend significantly more time on the website. An increase in registrations during the OFS (N=170) was identified: the mean amount of registrations per month was 13.2 during the randomized controlled trial and 56.7 during the OFS. Conclusions: Our findings did not show a significant difference in outcomes between the extensive SAFE intervention and the limited-intervention control group. It is, however, difficult to quantify the real contribution of the interactive components, as the control group also had access to a limited version of the intervention for ethical reasons. Both groups were satisfied with the intervention they received, with the intervention study arm significantly more so than the control study arm. Integrated and multilayered approaches are needed to aptly quantify the impact of web-based IPVA interventions for survivors. Trial Registration: Netherlands Trial Register NL7108 NTR7313; https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7313 %M 37368485 %R 10.2196/42641 %U https://www.jmir.org/2023/1/e42641 %U https://doi.org/10.2196/42641 %U http://www.ncbi.nlm.nih.gov/pubmed/37368485 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46734 %T A Smartphone-Delivered Program (Anathema) to Promote the Sexual Health of Older Adults, Colorectal Cancer Survivors, and Stroke Survivors: Protocol for a Feasibility Pilot Randomized Controlled Trial %A Mendes-Santos,Cristina %A Quinta-Gomes,Ana Luísa %A Pereira,Raquel %A Vasconcelos,Priscila %A Nobre,Pedro %A Couto,Joana %A Correia de Barros,Ana %+ Fraunhofer Portugal Center for Assistive Information and Communication Solutions, R. Alfredo Allen 455, Porto, 4200-135, Portugal, 351 220430350, cristina.santos@fraunhofer.pt %K colorectal cancer %K internet interventions %K smartphone %K older adults %K participatory design %K randomized controlled trial %K stroke %K survivors %D 2023 %7 27.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite the prevalence of sexual distress and dysfunction in older adults in general and stroke and colorectal cancer survivors in particular, access to specialized care is limited by organizational barriers and stigma, embarrassment, and discrimination. The internet allows reaching services that would otherwise be difficult or impossible to reach, and as smartphones are personal (intimate) technologies, they are a promising vehicle to close this gap. However, research focusing on smartphone-delivered sexual health promotion programs is scarce. Objective: This study aims to assess the acceptability, feasibility, and preliminary efficacy of Anathema, an 8-week, iOS/Android smartphone–delivered, individually tailored, cognitive-behavioral sexual health promotion program developed to improve relationship and sexual satisfaction, sexual functioning, sexual distress, sexual pleasure, and health-related quality of life (HRQoL) in older adults, colorectal cancer survivors, and stroke survivors compared to treatment as usual in a waiting-list control condition. Methods: Two-arm, parallel, open-label, waiting list, feasibility, pilot randomized controlled trials (RCTs) will be conducted involving older adults, stroke survivors, and colorectal cancer survivors. The primary outcomes are the acceptability, usability, and feasibility of Anathema. Sexual function, relationship and sexual satisfaction, sexual pleasure, sexual distress, anxiety, depression, and HRQoL are the secondary outcomes. This study has been reviewed and approved by the ethics committees of Instituto Português de Oncologia do Porto Francisco Gentil, Europacolon Portugal, Faculty of Psychology and Educational Sciences, University of Porto, and Sigmund Freud University (approval numbers: CES218R/021, CES19/023, and 2022/01-05b). Results: This project is funded by the European Commission through the Active and Assisted Living (AAL) Programme (reference: AAL-2020-7-133-CP) from April 2021 to December 2023. Recruitment for the pilot RCTs started on January 2023 in Portugal, Austria, and the Netherlands and is currently ongoing. As of May 2023, we randomized 49 participants in the trials. We expect to complete the RCTs in September 2023. The results on the acceptability, feasibility, and preliminary efficacy of Anathema are expected in the second semester of 2023. We expect Anathema to be highly accepted by the populations under study; to prove feasible to scale up to parent RCTs; and to be potentially efficacious in improving sexual functioning, relationship and sexual satisfaction, sexual distress, sexual pleasure, and HRQoL in older adults, colorectal cancer survivors, and stroke survivors compared to treatment as usual in a waiting-list control condition. The study results will be published in open-access venues according to COREQ (Consolidated Criteria for Reporting Qualitative Research) and CONSORT EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online Telehealth) guidelines. Conclusions: The study results will inform the refinement and scale-up of Anathema. Anathema’s wider-scale implementation can potentially promote the sexual health of largely neglected user groups such as older adults, colorectal cancer survivors, and stroke survivors. International Registered Report Identifier (IRRID): DERR1-10.2196/46734 %M 37368469 %R 10.2196/46734 %U https://www.researchprotocols.org/2023/1/e46734 %U https://doi.org/10.2196/46734 %U http://www.ncbi.nlm.nih.gov/pubmed/37368469 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46604 %T Associations Among Web-Based Civic Engagement and Discrimination, Web-Based Social Support, and Mental Health and Substance Use Risk Among LGBT Youth: Cross-Sectional Survey Study %A Tao,Xiangyu %A Fisher,Celia %+ Department of Psychology, Fordham University, 441 East Fordham Road, Dealy Hall, Bronx, NY, 10458, United States, 1 718 817 3793, fisher@fordham.edu %K lesbian, gay, bisexual, and transgender or nonbinary %K LGBT adolescents %K social media %K discrimination %K social support %K mental health %K substance use %D 2023 %7 26.6.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Social media use is ubiquitous among lesbian, gay, bisexual, and transgender or nonbinary (LGBT) adolescents. The time spent on LGBT sites and involvement in social justice–oriented web-based civic activities can increase exposure to heterosexist and transphobic posts, resulting in increases in depression, anxiety, and substance use. Collaborative social justice civic engagement may also increase LGBT adolescents’ social support on the web, which may buffer the mental health and substance use risks associated with web-based discrimination. Objective: Drawing on the minority stress and stress-buffering hypotheses, this study aimed to test time spent on LGBT sites, involvement in web-based social justice activities, the mediating effect of web-based discrimination, and the moderating effect of web-based social support on mental health and substance use. Methods: An anonymous web-based survey conducted from October 20 to November 18, 2022, analyzed data from 571 respondents (mean age 16.4, SD 1.1 years): 125 cisgender lesbian girls, 186 cisgender gay boys, 111 cisgender bisexual adolescents, and 149 transgender or nonbinary adolescents. Measures included demographics, web-based LGBT identity disclosure, hours per week spent on LGBT social media sites, engagement in web-based social justice activities (Online Civic Engagement Behavior Construct), exposure to web-based discrimination (Online Victimization Scale), web-based social support (adapted from scales examining web-based interactions), depressive and anxiety symptoms, and substance use (the Patient Health Questionnaire modified for Adolescents; Generalized Anxiety Disorder 7-item; and Car, Relax, Alone, Forget, Friends, Trouble Screening Test). Results: The time spent on LGBT social media sites was unrelated to web-based discrimination after civic engagement was accounted for (90% CI −0.007 to 0.004). Web-based social justice civic engagement was positively associated with social support (β=.4, 90% CI 0.2-0.4), exposure to discrimination (β=.6, 90% CI 0.5-0.7), and higher substance use risk (β=.2, 90% CI 0.2-0.6). Consistent with minority stress theory, exposure to web-based discrimination fully mediated the positive association between LGBT justice civic engagement and depressive (β=.3, 90% CI 0.2-0.4) and anxiety symptoms (β=.3, 90% CI 0.2-0.4). Web-based social support did not moderate the association between exposure to discrimination with depressive (90% CI −0.07 to 0.1) and anxiety symptoms (90% CI −0.06 to 0.1) and substance use (90% CI −0.04 to 0.01). Conclusions: This study highlights the importance of examining LGBT youth’s specific web-based activities and the need for future research to focus on the intersectional experiences of LGBT adolescents from racial and ethnic minoritized groups through culturally sensitive questions. This study also calls for social media platforms to implement policies that mitigate the effects of algorithms that expose youth to heterosexist and transphobic messaging, such as adopting machine learning algorithms that can efficiently recognize and remove harmful content. %M 37358882 %R 10.2196/46604 %U https://www.jmir.org/2023/1/e46604 %U https://doi.org/10.2196/46604 %U http://www.ncbi.nlm.nih.gov/pubmed/37358882 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e46286 %T The Effectiveness of a Mobile Phone–Based Physical Activity Program for Treating Depression, Stress, Psychological Well-Being, and Quality of Life Among Adults: Quantitative Study %A Kim,Hyungsook %A Lee,Kikwang %A Lee,Ye Hoon %A Park,Yoonjung %A Park,Yonghyun %A Yu,Yeonwoo %A Park,Jaeyoung %A Noh,Sihyeon %+ Division of Global Sport Industry, Hankuk University of Foreign Studies, 81, Oedae-ro, Mohyeon-eup, Cheoin-gu, Gyeonggi-do, 17035, Republic of Korea, 82 31 330 4986, leeye22@o365.hufs.ac.kr %K depressive symptoms %K mobile intervention %K exercise %K internet-based fitness %K mental health %D 2023 %7 26.6.2023 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Depression is a substantial global health problem, affecting >300 million people and resulting in 12.7% of all deaths. Depression causes various physical and cognitive problems, leading to a 5-year to 10-year decrease in life expectancy compared with the general population. Physical activity is known to be an effective, evidence-based treatment for depression. However, people generally have difficulties with participating in physical activity owing to limitations in time and accessibility. Objective: To address this issue, this study aimed to contribute to the development of alternative and innovative intervention methods for depression and stress management in adults. More specifically, we attempted to investigate the effectiveness of a mobile phone–based physical activity program on depression, perceived stress, psychological well-being, and quality of life among adults in South Korea. Methods: Participants were recruited and randomly assigned to the mobile phone intervention or waitlist group. Self-report questionnaires were used to assess variables before and after treatment. The treatment group used the program around 3 times per week at home for 4 weeks, with each session lasting about 30 minutes. To evaluate the program’s impact, a 2 (condition) × 2 (time) repeated-measures ANOVA was conducted, considering pretreatment and posttreatment measures along with group as independent variables. For a more detailed analysis, paired-samples 2-tailed t tests were used to compare pretreatment and posttreatment measurements within each group. Independent-samples 2-tailed t tests were conducted to assess intergroup differences in pretreatment measurements. Results: The study included a total of 68 adults aged between 18 and 65 years, who were recruited both through web-based and offline methods. Of these 68 individuals, 41 (60%) were randomly assigned to the treatment group and 27 (40%) to the waitlist group. The attrition rate was 10.2% after 4 weeks. The findings indicated that there is a significant main effect of time (F1,60=15.63; P=.003; ηp2=0.21) in participants’ depression scores, indicating that there were changes in depression level across time. No significant changes were observed in perceived stress (P=.25), psychological well-being (P=.35), or quality of life (P=.07). Furthermore, depression scores significantly decreased in the treatment group (from 7.08 to 4.64; P=.03; Cohen d=0.50) but not in the waitlist group (from 6.72 to 5.08; P=.20; Cohen d=0.36). Perceived stress score of the treatment group also significantly decreased (from 2.95 to 2.72; P=.04; Cohen d=0.46) but not in the waitlist group (from 2.82 to 2.74; P=.55; Cohen d=0.15). Conclusions: This study provided experimental evidence that mobile phone–based physical activity program affects depression significantly. By exploring the potential of mobile phone–based physical activity programs as a treatment option, this study sought to improve accessibility and encourage participation in physical activity, ultimately promoting better mental health outcomes for individuals with depression and stress. %M 37358905 %R 10.2196/46286 %U https://mhealth.jmir.org/2023/1/e46286 %U https://doi.org/10.2196/46286 %U http://www.ncbi.nlm.nih.gov/pubmed/37358905 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48927 %T Intergenerational Reminiscence Approach in Improving Emotional Well-Being of Older Asian Americans in Early-Stage Dementia Using Virtual Reality: Protocol for an Explanatory Sequential Mixed Methods Study %A Xu,Ling %A Hagedorn,Aaron %A Chi,Iris %+ School of Social Work, University of Texas at Arlington, 501 W Mitchell Street, Arlington, TX, 76019, United States, 1 817 272 3181, lingxu@uta.edu %K intergenerational reminiscence %K grandparent-grandchild %K dyad %K emotional %K well-being %K Asian American %K older adults %K dementia %K virtual reality %K VR %D 2023 %7 26.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: After a dementia diagnosis, Asian Americans experience anxiety, feelings of shame, and other negative effects. Emotional well-being is not only an important aspect of mental health, but also a quality of resilience that helps people bounce back faster from difficulties. However, few studies have addressed issues in developing, implementing, and testing intervention strategies to promote emotional well-being among older adults. Intergenerational solidarity between grandparents and grandchildren has been emphasized in Asian families and is beneficial for the health of persons with dementia. Reminiscence and life review have been identified as potentially effective intervention strategies for helping depression and emotional well-being for older adults. Objective: This proposed study aims to develop and implement an intergenerational reminiscence approach and evaluate its potential feasibility and effectiveness in improving the emotional well-being of older Asian American adults who have a recent dementia diagnosis. Methods: An explanatory sequential mixed methods design will be used in which quantitative data will first be collected and analyzed to identify subsamples of participants who report the greatest and least change in emotional well-being; then, these subsamples will be interviewed to further understand why or why not this intervention works for them. Older adults will receive 6 sessions of life review with grandchildren in virtual reality (VR; 1-1.5 hours each week for 6 weeks), aided by pictures and virtually traveling to important places in their life using Google Earth to look around at those places and remember important times. Quantitative survey data will be collected pre- and postintervention and at a 3-month follow-up. Qualitative interviews with selected participants will also be integrated into the study design. The quantitative data from the surveys will be entered into SPSS (IBM Corp) and analyzed using descriptive analyses, Pearson chi-square tests, nonparametric Friedman tests, or nonparametric Wilcox signed-rank tests (2-tailed). The qualitative data will be transcribed by research assistants, coded by the investigators independently, and analyzed with guidance from content analysis software (Atlas.ti; Atlas.ti Scientific Software Development GmbH). Results: The project was delayed due to the COVID-19 pandemic. Data collection started in late 2021, and 26 participants were recruited as of December 2022. While we are still cleaning and analyzing the quantitative data, the qualitative interviews showed promising results of this intergenerational reminiscence approach in improving emotional well-being among older Asian American adults who have cognitive impairment. Conclusions: Intergenerational reminiscence provided by grandchildren is promising in improving the emotional well-being of grandparents. VR technology is likely to be accepted by older adults. Future research may consider scaling up this pilot into a trackable, replicable model that includes more participants and develops a more rigorous study design with control groups to test the effectiveness of this intervention for older adults with dementia. International Registered Report Identifier (IRRID): DERR1-10.2196/48927 %M 37358895 %R 10.2196/48927 %U https://www.researchprotocols.org/2023/1/e48927 %U https://doi.org/10.2196/48927 %U http://www.ncbi.nlm.nih.gov/pubmed/37358895 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45852 %T A Digital Mental Health App Incorporating Wearable Biosensing for Teachers of Children on the Autism Spectrum to Support Emotion Regulation: Protocol for a Pilot Randomized Controlled Trial %A Palermo,Emma H %A Young,Amanda V %A Deswert,Sky %A Brown,Alyssa %A Goldberg,Miranda %A Sultanik,Evan %A Tan,Jessica %A Mazefsky,Carla A %A Brookman-Frazee,Lauren %A McPartland,James C %A Goodwin,Matthew S %A Pennington,Jeffrey %A Marcus,Steven C %A Beidas,Rinad S %A Mandell,David S %A Nuske,Heather J %+ Penn Center for Mental Health, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, 3rd Fl., Philadelphia, PA, 19104, United States, 1 215 746 6041, heather.nuske@pennmedicine.upenn.edu %K digital mental health %K just-in-time adaptive intervention augmentation %K JITAI %K autism %K heart rate tracking %K emotion dysregulation %K challenging behavior %K evidence-based strategies %K student progress monitoring %K mobile phone %D 2023 %7 26.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: As much as 80% of children on the autism spectrum exhibit challenging behaviors (ie, behaviors dangerous to the self or others, behaviors that interfere with learning and development, and behaviors that interfere with socialization) that can have a devastating impact on personal and family well-being, contribute to teacher burnout, and even require hospitalization. Evidence-based practices to reduce these behaviors emphasize identifying triggers (events or antecedents that lead to challenging behaviors); however, parents and teachers often report that challenging behaviors surface with little warning. Exciting recent advances in biometric sensing and mobile computing technology allow the measurement of momentary emotion dysregulation using physiological indexes. Objective: We present the framework and protocol for a pilot trial that will test a mobile digital mental health app, the KeepCalm app. School-based approaches to managing challenging behaviors in children on the autism spectrum are limited by 3 key factors: children on the autism spectrum often have difficulties in communicating their emotions; it is challenging to implement evidence-based, personalized strategies for individual children in group settings; and it is difficult for teachers to track which strategies are successful for each child. KeepCalm aims to address those barriers by communicating children’s stress to their teachers using physiological signaling (emotion dysregulation detection), supporting the implementation of emotion regulation strategies via smartphone pop-up notifications of top strategies for each child according to their behavior (emotion regulation strategy implementation), and easing the task of tracking outcomes by providing the child’s educational team with a tool to track the most effective emotion regulation strategies for that child based on physiological stress reduction data (emotion regulation strategy evaluation). Methods: We will test KeepCalm with 20 educational teams of students on the autism spectrum with challenging behaviors (no exclusion based on IQ or speaking ability) in a pilot randomized waitlist-controlled field trial over a 3-month period. We will examine the usability, acceptability, feasibility, and appropriateness of KeepCalm as primary outcomes. Secondary preliminary efficacy outcomes include clinical decision support success, false positives or false negatives of stress alerts, and the reduction of challenging behaviors and emotion dysregulation. We will also examine technical outcomes, including the number of artifacts and the proportion of time children are engaged in high physical movement based on accelerometry data; test the feasibility of our recruitment strategies; and test the response rate and sensitivity to change of our measures, in preparation for a future fully powered large-scale randomized controlled trial. Results: The pilot trial will begin by September 2023. Conclusions: Results will provide key data about important aspects of implementing KeepCalm in preschools and elementary schools and will provide preliminary data about its efficacy to reduce challenging behaviors and support emotion regulation in children on the autism spectrum. Trial Registration: ClinicalTrials.gov NCT05277194; https://www.clinicaltrials.gov/ct2/show/NCT05277194 International Registered Report Identifier (IRRID): PRR1-10.2196/45852 %M 37358908 %R 10.2196/45852 %U https://www.researchprotocols.org/2023/1/e45852 %U https://doi.org/10.2196/45852 %U http://www.ncbi.nlm.nih.gov/pubmed/37358908 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46431 %T User Satisfaction With a Daily Supportive Text Message Program (Text4PTSI) for Public Safety Personnel: Longitudinal Cross-Sectional Study %A Obuobi-Donkor,Gloria %A Eboreime,Ejemai %A Shalaby,Reham %A Agyapong,Belinda %A Phung,Natalie %A Eyben,Scarlett %A Wells,Kristopher %A Dias,Raquel da Luz %A Hilario,Carla %A Jones,Chelsea %A Brémault-Phillips,Suzette %A Zhang,Yanbo %A Greenshaw,Andrew J %A Agyapong,Vincent Israel Opoku %+ Department of Psychiatry, Faculty of Medicine, Dalhousie University, 5909 Veterans Memorial Lane, 8th Floor, Abbie J Lane Memorial Building, QEII Health Sciences Centre, Halifax, NS, B3H 2E2, Canada, 1 7802157771, agyapong@ualberta.ca %K public safety personnel %K Text4PTSI %K text messaging %K satisfaction %K occupational health %K work safety %K public safety %K digital health intervention %K mental health service %K user satisfaction %D 2023 %7 23.6.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Public safety personnel (PSP) are exposed to traumatic events due to their work environments, which increases the risk of mental health challenges. Providing effective and evidence-based interventions, such as SMS text messaging programs, can improve PSP's overall mental well-being with high user satisfaction rates. Objective: This study aims to evaluate users’ satisfaction, receptiveness, and perceptions of a cognitive behavioral therapy (CBT)–based supportive SMS text messaging intervention (Text4PTSI). Methods: Participants self-subscribed to Text4PTSI and received unidirectional cognitive behavioral–based supportive text messages for 6 months. Participants completed a web-based survey delivered via SMS text message at enrollment, and 6 weeks, 3 months, and 6 months post enrollment. Respondents’ perception and receptivity of the program were assessed using a questionnaire measured on a 5-point Likert scale. Data were collected as categorical variables, and overall satisfaction with the Text4PTSI program was measured on a scale from 0 to 100. Results: There were 131 subscribers to the Text4PTSI program; however, only 81 subscribers responded to the survey, producing 100 survey responses across the 3 follow-up time points. The overall mean score of satisfaction was 85.12 (SD 13.35). More than half of the survey responses agreed or strongly agreed that Text4PTSI helped participants cope with anxiety (79/100 responses, 79%), depressive symptoms (72/100 responses, 72%), and loneliness (54/100 responses, 54%). Similarly, most of the survey responses agreed or strongly agreed that the Text4PTSI program made respondents feel connected to a support system, improved their overall mental well-being (84/100 responses, 84%), felt more hopeful about managing concerns about their mental health or substance use (82 out of responses, 82%), and helped enhance their overall quality of life (77/100 responses, 77%). The available survey responses suggest that the majority always read the supportive text messages (84/100 responses, 84%), took time to reflect on each message (75/100 responses, 75%), and returned to read the text messages more than once (76/100 responses, 76%). Conclusions: PSP who responded to the follow-up surveys reported high user satisfaction and appreciation for receiving the Text4PTSI intervention during the 6-month program. The reported satisfaction with the service provided could pave the way to ensuring a better uptake of the service with potential effectiveness to end users. %M 37351940 %R 10.2196/46431 %U https://formative.jmir.org/2023/1/e46431 %U https://doi.org/10.2196/46431 %U http://www.ncbi.nlm.nih.gov/pubmed/37351940 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48898 %T Testing the Efficacy of a Scalable Telephone-Delivered Guided Imagery Tobacco Cessation Treatment: Protocol for a Randomized Clinical Trial %A Gordon,Judith S %A Armin,Julie S %A Giacobbi Jr,Peter %A Hsu,Chiu-Hsieh %A Marano,Kari %A Sheffer,Christine E %+ College of Nursing, University of Arizona, 1305 N Martin Avenue, Tucson, AZ, 85718, United States, 1 520 6264970, judithg@email.arizona.edu %K tobacco %K smoking %K treatment %K integrative health %K guided imagery %K behavior change %K telephone %K mobile phone %D 2023 %7 23.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Tobacco use continues to be a leading preventable cause of death and disease in the United States, accounting for >480,000 deaths each year. Although treatments for tobacco use are effective for many, there is substantial variability in outcomes, and these approaches are not effective for all individuals seeking to quit smoking cigarettes. New, effective therapeutic approaches are needed to meet the preferences of people who want to stop smoking. Guided imagery (GI) is a mind-body technique that involves the guided visualization of specific mental images, which is enhanced with other sensory modalities and emotions. Preliminary evidence provides initial support for the use of GI as a treatment for cigarette smoking. Meta-analyses have shown that standard treatment for cigarette smoking delivered over the telephone via quitlines is effective. A telephone-based intervention that uses GI might provide another effective treatment option and increase the reach and effectiveness of quitlines. Objective: This study aims to test the efficacy of Be Smoke Free, a telephone-delivered GI treatment for smoking cessation. Methods: This multisite randomized clinical trial (RCT) will compare a novel telephone-delivered GI tobacco cessation treatment with a standard evidence-based behavioral treatment. The study will be conducted over 5 years. In phase 1, we refined protocols and procedures for the New York State and West Virginia sites for use in the RCT. During phase 2, we will conduct an RCT with 1200 participants: 600 (50%) recruited via quitlines and 600 (50%) recruited via population-based methods. Participants will be randomly assigned to either the GI condition or the behavioral condition; both treatments will be delivered by trained study coaches located at the University of Arizona. Assessments will be conducted at baseline and 3 and 6 months after enrollment by University of Arizona research staff. The primary outcome will be self-reported 30-day point prevalence abstinence 6 months after enrollment. Secondary outcomes include biochemically verified 7-day point prevalence abstinence 6 months after enrollment. Results: Recruitment in West Virginia and New York began in October 2022. As of March 31, 2023, a total of 242 participants had been enrolled. Follow-up assessments began in November 2022. As of March 31, 2023, of the 118 eligible participants, 97 (82.2%) had completed the 3-month assessment, and 93% (26/28) of eligible participants had completed the 6-month assessment. Biochemical verification and qualitative interviews began in April 2023. Recruitment will continue through 2025 and follow-up assessments through 2026. Primary results are expected to be published in 2027. Conclusions: The Be Smoke Free study is a first-of-its-kind RCT that incorporates GI into telephone-based tobacco cessation treatment. If successful, Be Smoke Free will have substantial benefits for the long-term health of people who use tobacco across the United States. Trial Registration: ClinicalTrials.gov NCT05277831; https://clinicaltrials.gov/ct2/show/NCT05277831 International Registered Report Identifier (IRRID): PRR1-10.2196/48898 %M 37351932 %R 10.2196/48898 %U https://www.researchprotocols.org/2023/1/e48898 %U https://doi.org/10.2196/48898 %U http://www.ncbi.nlm.nih.gov/pubmed/37351932 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43740 %T A Web-Based Sexual Violence, Alcohol Misuse, and Bystander Intervention Program for College Women (RealConsent): Randomized Controlled Trial %A Salazar,Laura Francisca %A Schipani-McLaughlin,Anne Marie %A Sebeh,Yesser %A Nizam,Zainab %A Hayat,Matt %+ Department of Health Policy and Behavioral Science, School of Public Health, Georgia State University, Urban LIfe Bldg, 6th floor, 140 Decatur Street, Atlanta, GA, 30303, United States, 1 4044131396, lsalazar1@gsu.edu %K gender-based violence %K prospective study %K randomized controlled trial %K rape or prevention and control %K rape or statistics and numerical data %K school based %K violence %K alcohol %K women %K efficacy %K program %K intervention %K behavior %D 2023 %7 21.6.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Sexual violence (SV) incidence among college women has been invariant for the past 20 years. Innovative prevention strategies that are low resource and technology driven but demonstrate efficacy are greatly needed. Objective: The aim of this study was to determine the efficacy of a novel theoretically driven internet-based intervention for first-year college students who identify as women (RealConsent) in reducing their risk of exposure to SV and alcohol misuse as well as increasing alcohol protective and bystander behaviors. Methods: This randomized controlled trial involved first-year college students who identified as women (n=881) attending 1 of 3 universities in the southeastern United States. Participants aged 18 to 20 years were randomized to RealConsent (444/881, 50.4%) or to an attention-matched placebo control (437/881, 49.6%). RealConsent is fully automated and consists of four 45-minute modules that incorporate entertainment-education media and proven behavior change techniques. The primary outcome was exposure to SV; the secondary outcomes were alcohol protective behaviors, dating risk behaviors, alcohol misuse, and bystander behavior. Study outcomes were assessed at baseline and 6-month follow-up. Results: Among participants with some exposure to SV, those in the RealConsent group experienced less exposure to SV than the placebo group (adjusted incidence rate ratio 0.48, 95% CI 0.33-0.69; P=.002). Furthermore, participants in the RealConsent group engaged in more alcohol protective behaviors (adjusted odds ratio 1.17, 95% CI 0.12-2.22; P=.03) and were less likely to binge drink (adjusted incidence rate ratio 0.81, 95% CI 0.67-0.97; P=.003). Finally, participants in the RealConsent group who had 100% dosage were more likely to engage in bystander behavior than those with <100% dosage plus placebo group (adjusted odds ratio 1.72, 95% CI 1.17-2.55; P=.006). Conclusions: A comprehensive exposure to SV, alcohol use, and bystander educational program was successful in decreasing the occurrence of exposure to SV among those most at risk and in increasing alcohol protective behaviors. Because of its web-based and mobile technologies, RealConsent can be easily disseminated and holds potential for reducing campus SV. Trial Registration: ClinicalTrials.gov NCT03726437; https://clinicaltrials.gov/ct2/show/NCT03726437 %M 37342080 %R 10.2196/43740 %U https://www.jmir.org/2023/1/e43740 %U https://doi.org/10.2196/43740 %U http://www.ncbi.nlm.nih.gov/pubmed/37342080 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42083 %T Exploring the Use of the Behavior Change Technique Taxonomy and the Persuasive System Design Model in Defining Parent-Focused eHealth Interventions: Scoping Review %A Silva,Mindy %A Hay-Smith,E Jean %A Graham,Fiona %+ Rehabilitation Teaching and Research Unit, University of Otago, 23A Mein Street, Newtown, Wellington, 6021, New Zealand, 64 4 385 5541, research@wiredon.ltd %K persuasive technology %K behavior change %K parent-focused eHealth %K Capability, Opportunity, and Motivation–Behavior %K COM-B %K Fogg Behavior Model %K FBM %K behavior intervention %K publications %K effectiveness %K usability %K active ingredient %K scoping review %K mobile phone %D 2023 %7 21.6.2023 %9 Review %J J Med Internet Res %G English %X Background: Taxonomies and models are useful tools for defining eHealth content and intervention features, enabling comparison and analysis of research across studies and disciplines. The Behavior Change Technique Taxonomy version 1 (BCTTv1) was developed to decrease ambiguity in defining specific characteristics inherent in health interventions, but it was developed outside the context of digital technology. In contrast, the Persuasive System Design Model (PSDM) was developed to define and evaluate the persuasive content in software solutions but did not have a specific focus on health. Both the BCTTv1 and PSDM have been used to define eHealth interventions in the literature, with some researchers combining or reducing the taxonomies to simplify their application. It is unclear how well the taxonomies accurately define eHealth and whether they should be used alone or in combination. Objective: This scoping review explored how the BCTTv1 and PSDM capture the content and intervention features of parent-focused eHealth as part of a program of studies investigating the use of technology to support parents with therapy home programs for children with special health care needs. It explored the active ingredients and persuasive technology features commonly found in parent-focused eHealth interventions for children with special health care needs and how the descriptions overlap and interact with respect to the BCTTv1 and PSDM taxonomies. Methods: A scoping review was used to clarify concepts in the literature related to these taxonomies. Keywords related to parent-focused eHealth were defined and used to systematically search several electronic databases for parent-focused eHealth publications. Publications referencing the same intervention were combined to provide comprehensive intervention details. The data set was coded using codebooks developed from the taxonomies in NVivo (version 12; QSR International) and qualitatively analyzed using matrix queries. Results: The systematic search found 23 parent-focused eHealth interventions described in 42 articles from various countries; delivered to parents with children aged 1 to 18 years; and covering medical, behavioral, and developmental issues. The predominant active ingredients and intervention features in parent-focused eHealth were concerned with teaching parents behavioral skills, encouraging them to practice and monitor the new skills, and tracking the outcomes of performing the new skills. No category had a complete set of active ingredients or intervention features coded. The two taxonomies conceptually captured different constructs even when their labels appeared to overlap in meaning. In addition, coding by category missed important active ingredients and intervention features. Conclusions: The taxonomies were found to code different constructs related to behavior change and persuasive technology, discouraging the merging or reduction of the taxonomies. This scoping review highlighted the benefit of using both taxonomies in their entirety to capture active ingredients and intervention features important for comparing and analyzing eHealth across different studies and disciplines. International Registered Report Identifier (IRRID): RR2-doi.org/10.15619/nzjp/47.1.05 %M 37342082 %R 10.2196/42083 %U https://www.jmir.org/2023/1/e42083 %U https://doi.org/10.2196/42083 %U http://www.ncbi.nlm.nih.gov/pubmed/37342082 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e44346 %T Prevention and Treatment of Social Anxiety Disorder in Adolescents: Protocol for a Randomized Controlled Trial of the Online Guided Self-Help Intervention SOPHIE %A Walder,Noemi %A Berger,Thomas %A Schmidt,Stefanie J %+ Division of Clinical Child and Adolescent Psychology, Institute of Psychology, University of Bern, Fabrikstrasse 8, Bern, 3012, Switzerland, 41 316843691, noemi.walder@unibe.ch %K prevention %K treatment %K social anxiety disorder %K internet-based %K adolescent %K online intervention %K anxiety %K psychotherapy %K youth %K child %K comorbid %K mental health %K social phobia %K mobile phone %D 2023 %7 21.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Social anxiety symptoms are highly prevalent among adolescents and are associated with poor quality of life and low psychosocial functioning. If untreated, social anxiety often persists into adulthood and increases the risk for comorbid disorders. Therefore, early interventions for social anxiety to prevent negative long-term consequences are critical. However, adolescents rarely seek help and often avoid face-to-face psychotherapeutic interventions due to the perceived lack of autonomy and anonymity. Thus, online interventions represent a promising opportunity to reach adolescents who have social anxiety but do not seek help yet. Objective: This study aims to evaluate the efficacy, moderators, and mediators of an online intervention developed to reduce social anxiety in adolescents. Methods: A total of 222 adolescents aged 11-17 years with subclinical social anxiety (N=166) or with a diagnosis of social anxiety disorder (N=56) are randomly assigned to the online intervention or a care-as-usual control group. The 8-week guided online intervention is based on the Cognitive Model of Social Phobia and evidence-based online interventions for social anxiety adapted to the specific needs of adolescents. The care-as-usual group will be given access to the online intervention after the follow-up assessment. Participants are assessed at baseline, at 4 and 8 weeks post intervention, and at 3-month follow-up assessment on the primary outcome, that is, social anxiety, on secondary outcomes (eg, level of functioning, fear and avoidance, general anxiety, depression, quality of life, self-esteem, and negative effects of the intervention), on potential moderators (eg, therapy motivation, therapy expectancy, and satisfaction with the intervention), and potential mediators (eg, therapeutic alliance and adherence to the intervention). Data will be analyzed based on an intention-to-treat approach and both groups (intervention and care-as-usual) will be compared at each assessment time point. Furthermore, potential mechanisms of change and generalization of intervention effects on daily life are assessed using an ecological momentary assessment procedure that includes items on maintaining mechanisms of social anxiety, social context, and affect. Participants are prompted 3 times a day during the first 8 weeks of the study and again for 2 weeks following the follow-up assessment. Results: Recruitment is ongoing; initial results are expected in 2024. Conclusions: Results are discussed considering the potential of online interventions as a low-threshold prevention and treatment option for adolescents with social anxiety and in light of current advances in dynamic modeling of change processes and mechanisms in early intervention and psychotherapy in adolescents. Trial Registration: ClinicalTrials.gov NCT04782102; https://clinicaltrials.gov/ct2/show/NCT04782102 International Registered Report Identifier (IRRID): DERR1-10.2196/44346 %M 37342086 %R 10.2196/44346 %U https://www.researchprotocols.org/2023/1/e44346 %U https://doi.org/10.2196/44346 %U http://www.ncbi.nlm.nih.gov/pubmed/37342086 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46231 %T Characteristics of Users and Nonusers of Symptom Checkers in Germany: Cross-Sectional Survey Study %A Kopka,Marvin %A Scatturin,Lennart %A Napierala,Hendrik %A Fürstenau,Daniel %A Feufel,Markus A %A Balzer,Felix %A Schmieding,Malte L %+ Institute of Medical Informatics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charitépl 1, Berlin, 10117, Germany, 49 30 450 581 052, marvin.kopka@charite.de %K symptom checker %K cross-sectional study %K user characteristic %K digital public health %K health information seeking %K decision support %K eHealth %K mHealth %K Germany %K mobile health %K health app %K information seeking %K technology use %K usage %K demographic %K perception %K awareness %K adoption %D 2023 %7 20.6.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Previous studies have revealed that users of symptom checkers (SCs, apps that support self-diagnosis and self-triage) are predominantly female, are younger than average, and have higher levels of formal education. Little data are available for Germany, and no study has so far compared usage patterns with people’s awareness of SCs and the perception of usefulness. Objective: We explored the sociodemographic and individual characteristics that are associated with the awareness, usage, and perceived usefulness of SCs in the German population. Methods: We conducted a cross-sectional online survey among 1084 German residents in July 2022 regarding personal characteristics and people’s awareness and usage of SCs. Using random sampling from a commercial panel, we collected participant responses stratified by gender, state of residence, income, and age to reflect the German population. We analyzed the collected data exploratively. Results: Of all respondents, 16.3% (177/1084) were aware of SCs and 6.5% (71/1084) had used them before. Those aware of SCs were younger (mean 38.8, SD 14.6 years, vs mean 48.3, SD 15.7 years), were more often female (107/177, 60.5%, vs 453/907, 49.9%), and had higher formal education levels (eg, 72/177, 40.7%, vs 238/907, 26.2%, with a university/college degree) than those unaware. The same observation applied to users compared to nonusers. It disappeared, however, when comparing users to nonusers who were aware of SCs. Among users, 40.8% (29/71) considered these tools useful. Those considering them useful reported higher self-efficacy (mean 4.21, SD 0.66, vs mean 3.63, SD 0.81, on a scale of 1-5) and a higher net household income (mean EUR 2591.63, SD EUR 1103.96 [mean US $2798.96, SD US $1192.28], vs mean EUR 1626.60, SD EUR 649.05 [mean US $1756.73, SD US $700.97]) than those who considered them not useful. More women considered SCs unhelpful (13/44, 29.5%) compared to men (4/26, 15.4%). Conclusions: Concurring with studies from other countries, our findings show associations between sociodemographic characteristics and SC usage in a German sample: users were on average younger, of higher socioeconomic status, and more commonly female compared to nonusers. However, usage cannot be explained by sociodemographic differences alone. It rather seems that sociodemographics explain who is or is not aware of the technology, but those who are aware of SCs are equally likely to use them, independently of sociodemographic differences. Although in some groups (eg, people with anxiety disorder), more participants reported to know and use SCs, they tended to perceive them as less useful. In other groups (eg, male participants), fewer respondents were aware of SCs, but those who used them perceived them to be more useful. Thus, SCs should be designed to fit specific user needs, and strategies should be developed to help reach individuals who could benefit but are not aware of SCs yet. %M 37338970 %R 10.2196/46231 %U https://www.jmir.org/2023/1/e46231 %U https://doi.org/10.2196/46231 %U http://www.ncbi.nlm.nih.gov/pubmed/37338970 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e39487 %T The Effects of Scheduled Smoking Reduction and Precessation Nicotine Replacement Therapy on Smoking Cessation: Randomized Controlled Trial With Compliance %A Cinciripini,Paul M %A Minnix,Jennifer A %A Robinson,Jason D %A Kypriotakis,George %A Cui,Yong %A Blalock,Janice A %A Lam,Cho Y %A Wetter,David W %+ Department of Behavioral Science, University of Texas MD Anderson Cancer Center, 1155 Pressler St., Houston, TX, 77030, United States, 1 281 908 6782, gkypriotakis@mdanderson.org %K gradual reduction %K scheduled smoking %K nicotine replacement therapy %K smoking cessation %K compliance %K mobile phone %D 2023 %7 20.6.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Smoking remains a major public health problem, and it is important to provide a variety of efficacious and appealing options to encourage smokers to quit smoking. Scheduled smoking is a method of gradual reduction, preparing smokers to quit by systematically reducing cigarette consumption according to a predetermined schedule that increases the time between cigarette consumption. Gradual reduction may be preferred to abrupt quitting, but the efficacy of this cessation approach is unclear. Objective: This study aims, first, to evaluate the overall effectiveness of scheduled smoking alone, or in combination with precessation nicotine replacement therapy (NRT), versus standard NRT starting on the quit date with no prior smoking reduction and, second, to evaluate the impact of schedule compliance on the effectiveness of the intervention. Methods: A total of 916 participants recruited from the Houston metropolitan area were randomly assigned to 1 of the following 3 groups: scheduled smoking plus a precessation nicotine patch (n=306, 33.4%), scheduled smoking only with no precessation patch (n=309, 33.7%), and enhanced usual care (n=301, 32.9%) control. The primary abstinence outcomes were carbon monoxide–verified, self-reported, 7-day point prevalence abstinence at 2 and 4 weeks after the quit date. Unadjusted and adjusted logistic regression analyses were performed to evaluate the intervention effect. Scheduled smoking was implemented using a handheld device for 3 weeks before quitting. This trial was not registered because data collection began before July 1, 2005. Results: Results for the first aim showed no overall differences in abstinence among the 3 groups in both the unadjusted and adjusted models. However, the results for the second aim showed a clear effect on abstinence by schedule compliance at 2 and 4 weeks and 6 months after quitting (odds ratio [OR] 2.01, 95% CI 1.31-3.07), 4 weeks (OR 1.58, 95% CI 1.05-2.38), and 6 months (OR 1.68, 95% CI 1.04-2.64), with the differences at 2 and 4 weeks after quitting being the most robust. We also found that scheduled smoking was related to a reduction in nicotine withdrawal, negative affect, and craving when compared with the controls. Conclusions: Scheduled smoking, when combined with precessation use of NRT, can result in significantly higher abstinence rates than usual care (abrupt quitting with NRT), particularly in the early postquit phase (2 and 4 weeks after cessation) when smokers are compliant with the procedure. Scheduled smoking also produced a better overall quitting experience by reducing symptoms of nicotine withdrawal and craving, in comparison with usual care, which could encourage future quit attempts. Studies in this area should focus on the use of counseling or other methods to improve adherence. %M 37338956 %R 10.2196/39487 %U https://formative.jmir.org/2023/1/e39487 %U https://doi.org/10.2196/39487 %U http://www.ncbi.nlm.nih.gov/pubmed/37338956 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46062 %T Understanding Users’ Experiences of a Novel Web-Based Cognitive Behavioral Therapy Platform for Depression and Anxiety: Qualitative Interviews From Pilot Trial Participants %A Shkel,Jane %A Green,Gavin %A Le,Stacey %A Kaveladze,Benjamin %A Marcotte,Veronique %A Rushton,Kevin %A Nguyen,Theresa %A Schueller,Stephen M %+ Department of Psychological Science, University of California, Irvine, 4341 Social and Behavioral Sciences Gateway, Irvine, CA, 92697, United States, 1 949 824 3850, s.schueller@uci.edu %K anxiety %K depression %K cognitive behavioral therapy %K clinical trial %K intervention %K qualitative research %K digital mental health intervention %D 2023 %7 20.6.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital mental health interventions (DMHIs) can help bridge the gap between the demand for mental health care and availability of treatment resources. The affordances of DMHIs have been proposed to overcome barriers to care such as accessibility, cost, and stigma. Despite these proposals, most evaluations of the DMHI focus on clinical effectiveness, with less consideration of users’ perspectives and experiences. Objective: We conducted a pilot randomized controlled trial of “Overcoming Thoughts,” a web-based platform that uses cognitive and behavioral principles to address depression and anxiety. The “Overcoming Thoughts” platform included 2 brief interventions—cognitive restructuring and behavioral experimentation. Users accessed either a version that included asynchronous interactions with other users (“crowdsourced” platform) or a completely self-guided version (control condition). We aimed to understand the users’ perspectives and experiences by conducting a subset of interviews during the follow-up period of the trial. Methods: We used purposive sampling to select a subset of trial participants based on group assignment (treatment and control) and symptom improvement (those who improved and those who did not on primary outcomes). We conducted semistructured interviews with 23 participants during the follow-up period that addressed acceptability, usability, and impact. We conducted a thematic analysis of the interviews until saturation was reached. Results: A total of 8 major themes were identified: possible opportunities to expand the platform; improvements in mental health because of using the platform; increased self-reflection skills; platform being more helpful for certain situations or domains; implementation of skills into users’ lives, even without direct platform use; increased coping skills because of using the platform; repetitiveness of platform exercises; and use pattern. Although no differences in themes were found among groups based on improvement status (all P values >.05, ranging from .12 to .86), there were 4 themes that differed based on conditions (P values from .01 to .046): helpfulness of self-reflection supported by an exercise summary (greater in control); aiding in slowing thoughts and feeling calmer (greater in control); overcoming patterns of avoidance (greater in control); and repetitiveness of content (greater in the intervention). Conclusions: We identified the different benefits that users perceived from a novel DMHI and opportunities to improve the platform. Interestingly, we did not note any differences in themes between those who improved and those who did not, but we did find some differences between those who received the control and intervention versions of the platform. Future research should continue to investigate users’ experiences with DMHIs to better understand the complex dynamics of their use and outcomes. %M 37338967 %R 10.2196/46062 %U https://formative.jmir.org/2023/1/e46062 %U https://doi.org/10.2196/46062 %U http://www.ncbi.nlm.nih.gov/pubmed/37338967 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e46448 %T Providing Self-Led Mental Health Support Through an Artificial Intelligence–Powered Chat Bot (Leora) to Meet the Demand of Mental Health Care %A van der Schyff,Emma L %A Ridout,Brad %A Amon,Krestina L %A Forsyth,Rowena %A Campbell,Andrew J %+ Cyberpsychology Research Group, Biomedical Informatics and Digital Health Theme, School of Medical Sciences, The University of Sydney, Fisher Road, Sydney, 2006, Australia, 61 477179944, emma.vanderschyff@sydney.edu.au %K mental health %K chatbots %K conversational agents %K anxiety %K depression %K AI %K support %K web-based service %K web-based %K deployment %K stigma %K users %K symptoms %K mental health care %K self-led %D 2023 %7 19.6.2023 %9 Viewpoint %J J Med Internet Res %G English %X Digital mental health services are becoming increasingly valuable for addressing the global public health burden of mental ill-health. There is significant demand for scalable and effective web-based mental health services. Artificial intelligence (AI) has the potential to improve mental health through the deployment of chatbots. These chatbots can provide round-the-clock support and triage individuals who are reluctant to access traditional health care due to stigma. The aim of this viewpoint paper is to consider the feasibility of AI-powered platforms to support mental well-being. The Leora model is considered a model with the potential to provide mental health support. Leora is a conversational agent that uses AI to engage in conversations with users about their mental health and provide support for minimal-to-mild symptoms of anxiety and depression. The tool is designed to be accessible, personalized, and discreet, offering strategies for promoting well-being and acting as a web-based self-care coach. Across all AI-powered mental health services, there are several challenges in the ethical development and deployment of AI in mental health treatment, including trust and transparency, bias and health inequity, and the potential for negative consequences. To ensure the effective and ethical use of AI in mental health care, researchers must carefully consider these challenges and engage with key stakeholders to provide high-quality mental health support. Validation of the Leora platform through rigorous user testing will be the next step in ensuring the model is effective. %M 37335608 %R 10.2196/46448 %U https://www.jmir.org/2023/1/e46448 %U https://doi.org/10.2196/46448 %U http://www.ncbi.nlm.nih.gov/pubmed/37335608 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e42573 %T Computerized Cognitive Behavioral Therapy for Anxiety and Depression in Farming Communities: Mixed Methods Feasibility Study of Participant Use and Acceptability %A Bowyer,Harriet L %A Pegler,Ruth %A Williams,Christopher %+ Department of Psychology, Glasgow Caledonian University, Cowcaddens Rd, Glasgow, G4 0BA, United Kingdom, 44 1413318630, harriet.bowyer@gcu.ac.uk %K computerized cognitive behavioral therapy %K cCBT %K cognitive behavioral therapy %K CBT %K farmer %K depression %D 2023 %7 19.6.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Farmers have higher rates of depression than nonfarmers and higher rates of suicide than the general population. Several barriers to help seeking have been identified in farmers, which may be overcome by offering web-based mental health support. Computerized cognitive behavioral therapy (cCBT) is an effective intervention used to prevent and treat mild to moderate depression but has not been evaluated in the farming community. Objective: This study explored the feasibility of delivering a cCBT course tailored to farmers using a mixed methods approach. Methods: Farmers (aged ≥18 years) with no, minimal, or moderately severe depressive symptoms (Patient Health Questionnaire–9 [PHQ-9] score <20) were recruited using web-based and offline advertisements and given access to a cCBT course consisting of 5 core modules and automated and personalized email support. Depression (PHQ-9), anxiety (General Anxiety Disorder–7), and social functioning (Work and Social Adjustment Scale) were measured at baseline and the 8-week follow-up. Wilcoxon signed rank tests assessed changes in scores for all outcome measures over time. Telephone interviews focusing on participant use and satisfaction with the course were analyzed using thematic analysis. Results: Overall, 56 participants were recruited; 27 (48%) through social media. Overall, 62% (35/56) of participants logged into the course. At baseline, almost half of the participants reported experiencing minimal depressive symptoms (25/56, 45%) and mild anxiety (25/56, 45%), and just over half (30/56, 54%) reported mild to moderate functional impairment. Posttreatment data were available for 27% (15/56) of participants (41/56, 73% attrition rate). On average, participants experienced fewer depressive symptoms (P=.38) and less functional impairment (P=.26) at the 8-week follow-up; these results were not statistically significant. Participants experienced significantly fewer symptoms of anxiety at the 8-week follow-up (P=.02). Most participants (13/14, 93%) found the course helpful and easy to access (10/13, 77%) and the email support helpful (12/14, 86%). Qualitative interviews identified heavy workloads and mental health stigma within the farming community as barriers to help seeking. Participants thought that web-based support would be helpful, being convenient and anonymous. There were concerns that older farmers and those with limited internet connections may have difficulty accessing the course. Improvements regarding the layout and content of the course were suggested. Dedicated support from someone with farming knowledge was recommended to improve retention. Conclusions: cCBT may be a convenient way of supporting mental health within farming communities. However, challenges in recruiting and retaining farmers may indicate that cCBT supported only by email may not be an acceptable mode of mental health care delivery for many; however, it was valued by respondents. Involving farming organizations in planning, recruitment, and support may address these issues. Mental health awareness campaigns targeting farming communities may also help reduce stigma and improve recruitment and retention. %M 37335597 %R 10.2196/42573 %U https://formative.jmir.org/2023/1/e42573 %U https://doi.org/10.2196/42573 %U http://www.ncbi.nlm.nih.gov/pubmed/37335597 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e38275 %T Effect of Mobile Phone Text Messaging Self-Management Support for Patients With Diabetes or Coronary Heart Disease in a Chronic Disease Management Program (SupportMe) on Blood Pressure: Pragmatic Randomized Controlled Trial %A Cheung,Ngai Wah %A Redfern,Julie %A Thiagalingam,Aravinda %A Hng,Tien-Ming %A Marschner,Simone %A Haider,Rabbia %A Faruquie,Sonia %A Von Huben,Amy %A She,Shelley %A McIntyre,Daniel %A Cho,Jin-Gun %A Chow,Clara K %A , %+ Department of Diabetes & Endocrinology, Westmead Hospital, Hawkesbury Rd, Westmead, 2145, Australia, 61 288916796, wah.cheung@sydney.edu.au %K diabetes mellitus %K type 2 %K coronary disease %K chronic disease %K SMS text messaging %K delivery of health care %K integrated %K self-management %D 2023 %7 16.6.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Maintaining engagement and support for patients with chronic diseases is challenging. SMS text messaging programs have complemented patient care in a variety of situations. However, such programs have not been widely translated into routine care. Objective: We aimed to examine the implementation and utility of a customized SMS text message–based support program for patients with type 2 diabetes (T2D), coronary heart disease, or both within a chronic disease integrated care program. Methods: We conducted a 6-month pragmatic parallel-group, single-blind randomized controlled trial that recruited people with T2D or coronary heart disease. Intervention participants received 4 semipersonalized SMS text messages per week providing self-management support to supplement standard care. Preprogrammed algorithms customized content based on participant characteristics, and the messages were sent at random times of the day and in random order by a fully automated SMS text messaging engine. Control participants received standard care and only administrative SMS text messages. The primary outcome was systolic blood pressure. Evaluations were conducted face to face whenever possible by researchers blinded to randomization. Participants with T2D were evaluated for glycated hemoglobin level. Participant-reported experience measures were evaluated using questionnaires and focus groups and summarized using proportions and thematic analysis. Results: A total of 902 participants were randomized (n=448, 49.7% to the intervention group and n=454, 50.3% to the control group). Primary outcome data were available for 89.5% (807/902) of the participants. At 6 months, there was no difference in systolic blood pressure between the intervention and control arms (adjusted mean difference=0.9 mm Hg, 95% CI −1.1 to 2.1; P=.38). Of 642 participants with T2D, there was no difference in glycated hemoglobin (adjusted mean difference=0.1%, 95% CI −0.1% to 0.3%; P=.35). Self-reported medication adherence was better in the intervention group (relative risk=0.82, 95% CI 0.68-1.00; P=.045). Participants reported that the SMS text messages were useful (298/344, 86.6%) and easily understood (336/344, 97.7%) and motivated change (217/344, 63.1%). The lack of bidirectional messaging was identified as a barrier. Conclusions: The intervention did not improve blood pressure in this cohort, possibly because of high clinician commitment to improved routine patient care as part of the chronic disease management program as well as favorable baseline metrics. There was high program engagement, acceptability, and perceived value. Feasibility as part of an integrated care program was demonstrated. SMS text messaging programs may supplement chronic disease management and support self-care. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12616001689460; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371769&isReview=true International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2018-025923 %M 37327024 %R 10.2196/38275 %U https://www.jmir.org/2023/1/e38275 %U https://doi.org/10.2196/38275 %U http://www.ncbi.nlm.nih.gov/pubmed/37327024 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45061 %T mHealth Intervention for Promoting Hypertension Self-management Among African American Patients Receiving Care at a Community Health Center: Formative Evaluation of the FAITH! Hypertension App %A Brewer,LaPrincess C %A Jones,Clarence %A Slusser,Joshua P %A Pasha,Maarya %A Lalika,Mathias %A Chacon,Megan %A Takawira,Patricia %A Shanedling,Stanton %A Erickson,Paul %A Woods,Cynthia %A Krogman,Ashton %A Ferdinand,Daphne %A Underwood,Paul %A Cooper,Lisa A %A Patten,Christi A %A Hayes,Sharonne N %+ Department of Cardiovascular Medicine, Mayo Clinic College of Medicine, 200 1st St S.W., Rochester, MN, 55905, United States, 1 507 266 1376, brewer.laprincess@mayo.edu %K African Americans %K hypertension %K telemedicine %K health promotion %K community health workers %K community-based participatory research %K mobile phone %K mobile health %D 2023 %7 16.6.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: African American individuals are at a higher risk of premature death from cardiovascular diseases than White American individuals, with disproportionate attributable risk from uncontrolled hypertension. Given their high use among African American individuals, mobile technologies, including smartphones, show promise in increasing reliable health information access. Culturally tailored mobile health (mHealth) interventions may promote hypertension self-management among this population. Objective: This formative study aimed to assess the feasibility of integrating an innovative mHealth intervention into clinical and community settings to improve blood pressure (BP) control among African American patients. Methods: A mixed methods study of African American patients with uncontrolled hypertension was conducted over 2 consecutive phases. In phase 1, patients and clinicians from 2 federally qualified health centers (FQHCs) in the Minneapolis-St Paul, Minnesota area, provided input through focus groups to refine an existing culturally tailored mHealth app (Fostering African-American Improvement in Total Health! [FAITH!] App) for promoting hypertension self-management among African American patients with uncontrolled hypertension (renamed as FAITH! Hypertension App). Phase 2 was a single-arm pre-post intervention pilot study assessing feasibility and patient satisfaction. Patients receiving care at an FQHC participated in a 10-week intervention using the FAITH! Hypertension App synchronized with a wireless BP monitor and community health worker (CHW) support to address social determinants of health–related social needs. The multimedia app consisted of a 10-module educational series focused on hypertension and cardiovascular risk factors with interactive self-assessments, medication and BP self-monitoring, and social networking. Primary outcomes were feasibility (app engagement and satisfaction) and preliminary efficacy (change in BP) at an immediate postintervention assessment. Results: In phase 1, thirteen African American patients (n=9, 69% aged ≥50 years and n=10, 77% women) and 16 clinicians (n=11, 69% aged ≥50 years; n=14, 88% women; and n=10, 63% African American) participated in focus groups. Their feedback informed app modifications, including the addition of BP and medication tracking, BP self-care task reminders, and culturally sensitive contexts. In phase 2, sixteen African American patients were enrolled (mean age 52.6, SD 12.3 years; 12/16, 75% women). Overall, 38% (6/16) completed ≥50% of the 10 education modules, and 44% (7/16) completed the postintervention assessment. These patients rated the intervention a 9 (out of 10) on its helpfulness in hypertension self-management. Qualitative data revealed that they viewed the app as user-friendly, engaging, and informative, and CHWs were perceived as providing accountability and support. The mean systolic and diastolic BPs of the 7 patients decreased by 6.5 mm Hg (P=.15) and 2.8 mm Hg (P=.78), respectively, at the immediate postintervention assessment. Conclusions: A culturally tailored mHealth app reinforced by CHW support may improve hypertension self-management among underresourced African American individuals receiving care at FQHCs. A future randomized efficacy trial of this intervention is warranted. Trial Registration: ClinicalTrials.gov NCT04554147; https://clinicaltrials.gov/ct2/show/NCT04554147 %M 37115658 %R 10.2196/45061 %U https://formative.jmir.org/2023/1/e45061 %U https://doi.org/10.2196/45061 %U http://www.ncbi.nlm.nih.gov/pubmed/37115658 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44429 %T A Gamified Mobile App That Helps People Develop the Metacognitive Skills to Cope With Stressful Situations and Difficult Emotions: Formative Assessment of the InsightApp %A Amo,Victoria %A Prentice,Mike %A Lieder,Falk %+ Max Planck Institute for Intelligent Systems, Max Planck Ring 4, Tübingen, 72076, Germany, 49 15730645508, victoria.amo@tuebingen.mpg.de %K ecological momentary interventions %K serious games %K mindfulness-based interventions %K acceptance and commitment therapy %K cognitive behavioral therapy %K mobile phone %D 2023 %7 16.6.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Ecological momentary interventions open up new and exciting possibilities for delivering mental health interventions and conducting research in real-life environments via smartphones. This makes designing psychotherapeutic ecological momentary interventions a promising step toward cost-effective and scalable digital solutions for improving mental health and understanding the effects and mechanisms of psychotherapy. Objective: The first objective of this study was to formatively assess and improve the usability and efficacy of a gamified mobile app, the InsightApp, for helping people learn some of the metacognitive skills taught in cognitive behavioral therapy, acceptance and commitment therapy, and mindfulness-based interventions. The app aims to help people constructively cope with stressful situations and difficult emotions in everyday life. The second objective of this study was to test the feasibility of using the InsightApp as a research tool for investigating the efficacy of psychological interventions and their underlying mechanisms. Methods: We conducted 2 experiments. In experiment 1 (n=65; completion rate: 63/65, 97%), participants (mean age 27, SD 14.9; range 19-55 years; 41/60, 68% female) completed a single session with the InsightApp. The intervention effects on affect, belief endorsement, and propensity for action were measured immediately before and after the intervention. Experiment 2 (n=200; completion rate: 142/200, 71%) assessed the feasibility of conducting a randomized controlled trial using the InsightApp. We randomly assigned participants to an experimental or a control condition, and they interacted with the InsightApp for 2 weeks (mean age 37, SD 12.16; range 20-78 years; 78/142, 55% female). Experiment 2 included all the outcome measures of experiment 1 except for the self-reported propensity to engage in predefined adaptive and maladaptive behaviors. Both experiments included user experience surveys. Results: In experiment 1, a single session with the app seemed to decrease participants’ emotional struggle, the intensity of their negative emotions, their endorsement of negative beliefs, and their self-reported propensity to engage in maladaptive coping behaviors (P<.001 in all cases; average effect size=−0.82). Conversely, participants’ endorsement of adaptive beliefs and their self-reported propensity to act in accordance with their values significantly increased (P<.001 in all cases; average effect size=0.48). Experiment 2 replicated the findings of experiment 1 (P<.001 in all cases; average effect size=0.55). Moreover, experiment 2 identified a critical obstacle to conducting a randomized controlled trial (ie, asymmetric attrition) and how it might be overcome. User experience surveys suggested that the app’s design is suitable for helping people apply psychotherapeutic techniques to cope with everyday stress and anxiety. User feedback provided valuable information on how to further improve app usability. Conclusions: In this study, we tested the first prototype of the InsightApp. Our encouraging preliminary results show that it is worthwhile to continue developing the InsightApp and further evaluate it in a randomized controlled trial. %M 37327040 %R 10.2196/44429 %U https://formative.jmir.org/2023/1/e44429 %U https://doi.org/10.2196/44429 %U http://www.ncbi.nlm.nih.gov/pubmed/37327040 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43903 %T Adapting a Telephone-Based, Dyadic Self-management Program to Be Delivered Over the Web: Methodology and Usability Testing %A Trivedi,Ranak %A Hirayama,Sierra Kawena %A Risbud,Rashmi %A Suresh,Madhuvanthi %A Humber,Marika Blair %A Butler,Kevin %A Razze,Alex %A Timko,Christine %A Nelson,Karin %A Zulman,Donna M %A Asch,Steven M %A Humphreys,Keith %A Piette,John D %+ Center for Innovation to Implementation, Veteran Affairs Palo Alto Health Care System, 795 Willow Rd Bldg 324, 152-MPD Ci2i, Menlo Park, CA, 94025, United States, 1 4157872805, ranakt@stanford.edu %K dyadic %K eHealth %K behavioral interventions %K self-management %K caregiver %K web-based %K interventions %K stress management %K self-care %D 2023 %7 16.6.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The COVID-19 pandemic has amplified the need for web-based behavioral interventions to support individuals who are diagnosed with chronic conditions and their informal caregivers. However, most interventions focus on patient outcomes. Dyadic technology–enabled interventions that simultaneously improve outcomes for patients and caregivers are needed. Objective: This study aimed to describe the methodology used to adapt a telephone-based, facilitated, and dyadic self-management program called Self-care Using Collaborative Coping Enhancement in Diseases (SUCCEED) into a self-guided, web-based version (web-SUCCEED) and to conduct usability testing for web-SUCCEED. Methods: We developed web-SUCCEED in 6 steps: ideation—determine the intervention content areas; prototyping—develop the wireframes, illustrating the look and feel of the website; prototype refinement via feedback from focus groups; finalizing the module content; programming web-SUCCEED; and usability testing. A diverse team of stakeholders including content experts, web designers, patients, and caregivers provided input at various stages of development. Costs, including full-time equivalent employee, were summarized. Results: At the ideation stage, we determined the content of web-SUCCEED based on feedback from the program’s original pilot study. At the prototyping stage, the principal investigator and web designers iteratively developed prototypes that included inclusive design elements (eg, large font size). Feedback about these prototypes was elicited through 2 focus groups of veterans with chronic conditions (n=13). Rapid thematic analysis identified two themes: (1) web-based interventions can be useful for many but should include ways to connect with other users and (2) prototypes were sufficient to elicit feedback about the esthetics, but a live website allowing for continual feedback and updating would be better. Focus group feedback was incorporated into building a functional website. In parallel, the content experts worked in small groups to adapt SUCCEED’s content, so that it could be delivered in a didactic, self-guided format. Usability testing was completed by veterans (8/16, 50%) and caregivers (8/16, 50%). Veterans and caregivers gave web-SUCCEED high usability scores, noting that it was easy to understand, easy to use, and not overly burdensome. Notable negative feedback included “slightly agreeing” that the site was confusing and awkward. All veterans (8/8, 100%) agreed that they would choose this type of program in the future to access an intervention that aims to improve their health. Developing and maintaining the software and hosting together cost approximately US $100,000, excluding salary and fringe benefits for project personnel (steps 1-3: US $25,000; steps 4-6: US $75,000). Conclusions: Adapting an existing, facilitated self-management support program for delivery via the web is feasible, and such programs can remotely deliver content. Input from a multidisciplinary team of experts and stakeholders can ensure the program’s success. Those interested in adapting programs should have a realistic estimate of the budget and staffing requirements. %M 37327057 %R 10.2196/43903 %U https://formative.jmir.org/2023/1/e43903 %U https://doi.org/10.2196/43903 %U http://www.ncbi.nlm.nih.gov/pubmed/37327057 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e41590 %T Feasibility and Preliminary Efficacy of Digital Interventions for Depressive Symptoms in Working Adults: Multiarm Randomized Controlled Trial %A Taylor,Rachael Wallis %A Male,Rhian %A Economides,Marcos %A Bolton,Heather %A Cavanagh,Kate %+ Unmind Ltd, 180 Borough High Street, London, SE1 1LB, United Kingdom, 44 7814522979, rachaelwtaylor@gmail.com %K depression %K digital intervention %K randomized controlled trial %K RCT %K cognitive behavioral therapy %K CBT %K acceptance and commitment therapy %K ACT %K behavioral activation %K BA %K mobile phone %D 2023 %7 16.6.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Depressive symptoms are highly prevalent and have broad-ranging negative implications. Digital interventions are increasingly available in the workplace context, but supporting evidence is limited. Objective: This study aimed to evaluate the feasibility, acceptability, and preliminary efficacy of 3 digital interventions for depressive symptoms in a sample of UK-based working adults experiencing mild to moderate symptoms. Methods: This was a parallel, multiarm, pilot randomized controlled trial. Participants were allocated to 1 of 3 digital interventions or a waitlist control group and had 3 weeks to complete 6 to 8 short self-guided sessions. The 3 interventions are available on the Unmind mental health app for working adults and draw on behavioral activation, cognitive behavioral therapy, and acceptance and commitment therapy. Web-based assessments were conducted at baseline, postintervention (week 3), and at 1-month follow-up (week 7). Participants were recruited via Prolific, a web-based recruitment platform, and the study was conducted entirely on the web. Feasibility and acceptability were assessed using objective engagement data and self-reported feedback. Efficacy outcomes were assessed using validated self-report measures of mental health and functioning and linear mixed models with intention-to-treat principles. Results: In total, 2003 individuals were screened for participation, of which 20.22% (405/2003) were randomized. A total of 92% (373/405) of the participants were retained in the study, 97.4% (295/303) initiated their allocated intervention, and 66.3% (201/303) completed all sessions. Moreover, 80.6% (229/284) of the participants rated the quality of their allocated intervention as excellent or good, and 79.6% (226/284) of the participants were satisfied or very satisfied with their intervention. All active groups showed improvements in well-being, functioning, and depressive and anxiety symptoms compared with the control group, which were maintained at 4 weeks. Hedges g effect sizes for depressive symptoms ranged from −0.53 (95% CI −0.25 to −0.81) to −0.74 (95% CI −0.45 to −1.03). Conclusions: All interventions were feasible and acceptable, and the preliminary efficacy findings indicated that their use may improve depressive symptoms, well-being, and functioning. The predefined criteria for a definitive trial were met. Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN) ISRCTN13067492; https://www.isrctn.com/ISRCTN13067492 %M 37327027 %R 10.2196/41590 %U https://formative.jmir.org/2023/1/e41590 %U https://doi.org/10.2196/41590 %U http://www.ncbi.nlm.nih.gov/pubmed/37327027 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45100 %T Positive Psychological Intervention Delivered Using Virtual Reality in Patients on Hemodialysis With Comorbid Depression: Protocol and Design for the Joviality Randomized Controlled Trial %A Hernandez,Rosalba %A Wilund,Ken %A Solai,Killivalavan %A Tamayo,David %A Fast,Drew %A Venkatesan,Prasakthi %A Lash,James P %A Lora,Claudia M %A Martinez,Lizet %A Martin Alemañy,Geovana %A Martinez,Angela %A Kwon,Soonhyung %A Romero,Dana %A Browning,Matthew H E M %A Moskowitz,Judith T %+ Department of Population Health Nursing Science, College of Nursing, University of Illinois Chicago, 845 S Damen Ave, MC 802, Chicago, IL, 60612, United States, 1 3129965706, rherna17@uic.edu %K virtual reality %K hemodialysis %K positive psychology %K emotional well-being %K mindfulness %K depression %K comorbid depression %D 2023 %7 16.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Depression is highly prevalent in individuals on hemodialysis, but it is infrequently identified and remains undertreated. In this paper, we present details of the methodology of a randomized controlled trial (RCT) aimed at testing the feasibility and preliminary efficacy of a 5-week positive psychological intervention in individuals on hemodialysis with comorbid depression delivered using immersive virtual reality (VR) technology. Objective: We aim to describe the protocol and design of the Joviality trial whose main objectives are 2-fold: determine the feasibility of the Joviality VR software through metrics capturing rates of recruitment, refusal, retention, noncompliance, and adherence, as well as end-user feedback; and assess preliminary efficacy for outcomes measures of depressive symptoms, psychological well-being and distress, quality of life, treatment adherence, clinical biomarkers, and all-cause hospitalizations. Methods: This 2-arm RCT is scheduled to enroll 84 individuals on hemodialysis with comorbid depression from multiple outpatient centers in Chicago, Illinois, United States. Enrollees will be randomized to the following groups: VR-based Joviality positive psychological intervention or sham VR (2D wildlife footage and nature-based settings with inert music presented using a head-mounted display). To be eligible, individuals must be on hemodialysis for at least 3 months, have Beck Depression Inventory-II scores of ≥11 (ie, indicative of mild-to-severe depressive symptoms), be aged ≥21 years, and be fluent in English or Spanish. The Joviality VR software was built using agile design principles and incorporates fully immersive content, digital avatars, and multiplex features of interactability. Targeted skills of the intervention include noticing positive events, positive reappraisal, gratitude, acts of kindness, and mindful or nonjudgmental awareness. The primary outcomes include metrics of feasibility and acceptability, along with preliminary efficacy focused on decreasing symptoms of depression. The secondary and tertiary outcomes include quality of life, treatment adherence, clinical biomarkers, and all-cause hospitalization rates. There are 4 assessment time points: baseline, immediately after the intervention, 3 months after the intervention, and 6 months after the intervention. We hypothesize that depressive symptoms and hemodialysis-related markers of disease will substantially improve in participants randomized to the VR-based Joviality positive psychology treatment arm compared with those in the attention control condition. Results: This RCT is funded by the National Institute of Diabetes and Digestive and Kidney Diseases and is scheduled to commence participant recruitment in June 2023. Conclusions: This trial will be the first to test custom-built VR software to deliver a positive psychological intervention, chairside, in individuals on hemodialysis to reduce symptoms of depression. Within the context of an RCT using an active control arm, if proven effective, VR technology may become a potent tool to deliver mental health programming in clinical populations during their outpatient treatment sessions. Trial Registration: ClinicalTrials.gov NCT05642364; https://clinicaltrials.gov/ct2/show/NCT05642364 International Registered Report Identifier (IRRID): PRR1-10.2196/45100 %M 37327026 %R 10.2196/45100 %U https://www.researchprotocols.org/2023/1/e45100 %U https://doi.org/10.2196/45100 %U http://www.ncbi.nlm.nih.gov/pubmed/37327026 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e36578 %T A Smartphone-Based Implicit Theories Intervention for Health Behavior Change: Randomized Trial %A Schreiber,Mike %A Dohle,Simone %+ Faculty of Psychology, University of Vienna, Universitätsstr 7, Vienna, 1010, Austria, 43 1427747353, mike.schreiber@univie.ac.at %K daily diary %K ecological momentary assessment %K health behavior %K implicit theories %K lay theories %K mindsets %K multiple health behavior change %K randomized trial %K smartphone-based intervention %D 2023 %7 15.6.2023 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Implicit theories of health describe individuals’ beliefs about the malleability of health. Individuals with an incremental theory of health believe that health, in general, is malleable, whereas individuals with an entity theory of health endorse the idea that health is largely fixed and predetermined. Previous research has shown that an incremental theory of health is associated with beneficial health outcomes and behaviors. A mobile health implicit theories intervention could be an effective way to increase health-promoting behaviors in the general population. Objective: The aim of this study was to estimate the effect of a smartphone-based intervention designed to promote an incremental theory of health on the frequency of health-promoting behaviors in everyday life. The study used ecological momentary assessment to measure health behavior change. Methods: This 2-arm, single-blind, delayed intervention design included 149 German participants (mean age 30.58, SD 9.71 years; n=79 female). Participants were asked to report their engagement in 10 health-promoting behaviors throughout the day for 3 weeks. Participants were randomly assigned to either an early intervention group (n=72) or a delayed intervention group (n=77). The intervention materials, designed to promote an incremental theory of health, were provided to participants after 1 week (early intervention group) or 2 weeks (delayed intervention group) of baseline behavior measurement. Data for this study were collected between September 2019 and October 2019. Results: A paired-samples 2-tailed t test revealed that participants reported a stronger incremental theory after responding to the intervention materials (mean 5.58, SE 0.07) compared with incremental theory measured in an entry questionnaire (mean 5.29, SE 0.08; t148=4.07, SE 0.07; P<.001; 95% CI 0.15-0.43; d=0.33). Multilevel analyses showed that participants reported engaging in health-promoting behaviors more often after being presented with the intervention materials compared with baseline across conditions (b=0.14; t146.65=2.06, SE 0.07; P=.04; 95% CI 0.01-0.28). However, when the analysis was conducted separately for the early and delayed intervention groups, the intervention effect was only significant for the delayed intervention group (b=0.27; t1492.37=3.50, SE 0.08; P<.001; 95% CI 0.12-0.42). There was no significant increase in health-promoting behaviors for the early intervention group (b=0.02; t69.23=0.14, SE 0.11;P=.89; 95% CI −0.2 to 0.23). Conclusions: This study suggests that a smartphone-based intervention designed to promote an incremental theory of health is a cost- and time-effective approach to increase the frequency of engaging in health-promoting behaviors. However, research is needed to understand the reasons for the difference in intervention effects between the early and delayed intervention groups. The results of this study can guide the development of future digital health interventions that focus on implicit theories to promote health behavior change. Trial Registration: DRKS – German Clinical Trials Register DRKS00017379; https://drks.de/search/de/trial/DRKS00017379 %M 37318864 %R 10.2196/36578 %U https://mhealth.jmir.org/2023/1/e36578 %U https://doi.org/10.2196/36578 %U http://www.ncbi.nlm.nih.gov/pubmed/37318864 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 7 %N %P e46828 %T Cardiac Rehabilitation Facebook Intervention: Feasibility Randomized Controlled Trial %A Siegmund,Lee Anne %A Bena,James F %A Morrison,Shannon L %+ Nursing Research and Innovation, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH, 44195, United States, 1 216 618 5126, siegmul@ccf.org %K cardiac rehabilitation %K motivation %K exercise %K social media %K cardiology %K adherence %K physical activity %K satisfaction %K rehabilitation %K Facebook %K peer support %D 2023 %7 15.6.2023 %9 Original Paper %J JMIR Cardio %G English %X Background: The adherence to cardiac rehabilitation is low. Social media has been used to improve motivation and cardiac rehabilitation completion, but the authors did not find Facebook interventions for these purposes in the literature. Objective: The purpose of this study was to determine the feasibility of the Cardiac Rehabilitation Facebook Intervention (Chat) for affecting changes in exercise motivation and need satisfaction and adherence to cardiac rehabilitation. Methods: The Behavioral Regulation in Exercise Questionnaire-3 and Psychological Need Satisfaction for Exercise were used to measure motivation and need satisfaction (competence, autonomy, and relatedness) before and after the Chat intervention. To support need satisfaction, the intervention included educational posts, supportive posts, and interaction with peers. The feasibility measures included recruitment, engagement, and acceptability. Groups were compared using analysis of variance and Kruskal-Wallis tests. Paired t tests were used to assess motivation and need satisfaction change, and Pearson or Spearman correlations were used for continuous variables. Results: A total of 32 participants were lost to follow-up and 22 were included in the analysis. Higher motivation at intake (relative autonomy index 0.53, 95% CI 0.14-0.78; P=.01) and change in need satisfaction-autonomy (relative autonomy index 0.61, 95% CI 0.09-0.87; P=.02) were associated with more completed sessions. No between-group differences were found. Engagement included “likes” (n=210) and “hits” (n=157). For acceptability, mean scores on a 1 (not at all) to 5 (quite a bit) Likert scale for feeling supported and in touch with providers were 4.6 and 4.4, respectively. Conclusions: Acceptability of the Chat group was high; however, intervention feasibility could not be determined due to the small sample size. Those with greater motivation at intake completed more sessions, indicating its importance in cardiac rehabilitation completion. Despite challenges with recruitment and engagement, important lessons were learned. Trial Registration: ClinicalTrials.gov NCT02971813; https://clinicaltrials.gov/ct2/show/NCT02971813 International Registered Report Identifier (IRRID): RR2-10.2196/resprot.7554 %M 37318865 %R 10.2196/46828 %U https://cardio.jmir.org/2023/1/e46828 %U https://doi.org/10.2196/46828 %U http://www.ncbi.nlm.nih.gov/pubmed/37318865 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e41227 %T Engagement, Retention, and Acceptability in a Digital Health Program for Atopic Dermatitis: Prospective Interventional Study %A Gudmundsdóttir,Sigrídur Lára %A Ballarini,Tommaso %A Ámundadóttir,María L %A Mészáros,Judit %A Eysteinsdottir,Jenna Huld %A Thorleifsdottir,Ragna H %A Hrafnkelsdóttir,Sigrídur K %A Helgadottir,Halla %A Oddsson,Saemundur %A Silverberg,Jonathan I %+ Sidekick Health Digital Therapeutics, Vallakor 4, Kopavogur, 203, Iceland, 354 6992254, halla@sidekickhealth.com %K digital therapeutics %K DTX %K eHealth %K engagement %K retention %K atopic dermatitis %K eczema %K medication reminder %K symptom tracking %K patient-reported outcomes %K quality of life %K dermatology %K feasibility %K mobile phone %D 2023 %7 14.6.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Patients with atopic dermatitis can experience chronic eczema with pruritus, skin pain, sleep problems, anxiety, and other problems that reduce their quality of life (QoL). Current treatments aim to improve these symptoms and reduce inflammation, but poor treatment adherence and disease understanding are key concerns in the long-term management of atopic dermatitis. Digital therapeutics can help with these and support patients toward a healthier lifestyle to improve their overall QoL. Objective: The aim of the study is to test the feasibility of a digital health program tailored for atopic dermatitis through program engagement, retention, and acceptability. Methods: Adults with atopic dermatitis were recruited in Iceland for a 6-week digital health program delivered through a smartphone app. Key components of the digital program were disease and trigger education; medication reminders; patient-reported outcomes (PROs) on energy levels, stress levels, and quality of sleep (referred to as QoL PROs); atopic dermatitis symptom PROs; guided meditation; and healthy lifestyle coaching. The primary outcome was program feasibility, as assessed by in-app retention and engagement. User satisfaction was assessed by the mHealth (ie, mobile health) App Usability Questionnaire (MAUQ). Results: A total of 21 patients were recruited (17 female, mean age 31 years), 20 (95%) completed the program. On average, users were active in the app 6.5 days per week and completed 8.2 missions per day. The education content, medication reminders, and PROs had high user engagement and retention; all users who were exposed to the QoL PROs (n=17) interacted with these, and 20/21 (95%) users were continuously engaged with the education missions, medication missions, and symptom PROs. Continued engagement with the step counter and mind missions among exposed users was lower (17/21 and 13/20 participants, respectively). Medication reminder and education task completion remained high over time (at least 18/20, 90%), but weekly interactions declined. All assigned users completed atopic dermatitis symptom PROs on weeks 1-5 and only one did not do so on week 6; the reported number and total severity of atopic dermatitis symptoms reduced during the program. Regarding the QoL PROs, 16/17 (94%) and 14/17 (82%) users interacted with these at least 3 times in the first and last week of the program, respectively, and all reported improvements over time. User satisfaction was high with a total score of 6.2/7. Conclusions: We found high overall engagement and retention in a targeted digital health program among patients with atopic dermatitis, as well as high compliance with missions relating to medication reminders, patient education, and PROs. Symptom number and severity were reduced, and QoL PROs improved over time. We conclude that a digital health program is feasible and may provide added benefits for patients with atopic dermatitis, including the tracking and improvement of atopic dermatitis symptoms. %M 36975050 %R 10.2196/41227 %U https://formative.jmir.org/2023/1/e41227 %U https://doi.org/10.2196/41227 %U http://www.ncbi.nlm.nih.gov/pubmed/36975050 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48228 %T Rationale, Design, and Methods for the Sedentary Behavior Reduction in Pregnancy Intervention (SPRING): Protocol for a Pilot and Feasibility Randomized Controlled Trial %A Barone Gibbs,Bethany %A Kozai,Andrea C %A McAdoo,Shannon N %A Bastyr,Meghan C %A Davis,Kelliann D %A Hauspurg,Alisse %A Catov,Janet M %+ Department of Epidemiology and Biostatistics, West Virginia University School of Public Health, 64 Medical Center Drive, PO Box 9190, Morgantown, WV, 26506, United States, 1 4123105988, bethany.gibbs@hsc.wvu.edu %K pregnancy %K behavioral intervention %K pilot and feasibility trial %K sedentary behavior %K physical activity %K mobile phone %D 2023 %7 14.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adverse pregnancy outcomes (APOs) identify cardiovascular disease risk, but few effective interventions are available. High sedentary behavior (SED) has recently been associated with APOs, but very few randomized controlled trials (RCTs) have tested SED reduction in pregnancy. Objective: The Sedentary Behavior Reduction in Pregnancy Intervention (SPRING) pilot and feasibility RCT addresses this gap by testing the feasibility, acceptability, and preliminary pregnancy health effects of an intervention to reduce SED in pregnant women. The objective of this manuscript is to describe the rationale and design of SPRING. Methods: Pregnant participants (n=53) in their first trimester, who are at risk for high SED and APO and without contraindications, are randomized in a 2:1 ratio to an intervention or control group. SED (primary outcome) and standing durations, and steps per day, are measured objectively in each trimester for 1 week with a thigh-mounted activPAL3 accelerometer. SPRING also seeks to demonstrate feasibility and acceptability while estimating preliminary effects on maternal-fetal health outcomes assessed during study visits and abstracted from medical records. The pregnancy-customized intervention promotes daily behavioral targets of less than 9 hours of SED and at least 7500 steps, achieved via increased standing and incorporating light-intensity movement breaks each hour. The multicomponent intervention provides a height-adjustable workstation, a wearable activity monitor, behavioral counseling every 2 weeks (through videoconference), and membership in a private social media group. Herein, we review the rationale, describe recruitment and screening processes, and detail the intervention, assessment protocols, and planned statistical analyses. Results: This study was funded by the American Heart Association (20TPA3549099), with a funding period of January 1, 2021, and until December 31, 2023. Institutional review board approval was obtained on February 24, 2021. Participants were randomized between October 2021 and September 2022, with final data collection planned for May 2023. Analyses and submission of results are expected for winter of 2023. Conclusions: The SPRING RCT will provide initial evidence on the feasibility and acceptability of an SED-reduction intervention to decrease SED in pregnant women. These data will inform the design of a large clinical trial testing SED reduction as a strategy to reduce APO risk. Trial Registration: ClincialTrials.gov NCT05093842; https://clinicaltrials.gov/ct2/show/NCT05093842 International Registered Report Identifier (IRRID): DERR1-10.2196/48228 %M 37314845 %R 10.2196/48228 %U https://www.researchprotocols.org/2023/1/e48228 %U https://doi.org/10.2196/48228 %U http://www.ncbi.nlm.nih.gov/pubmed/37314845 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e43418 %T Testing Behavior Change Techniques to Increase Physical Activity in Middle-Aged and Older Adults: Protocol for a Randomized Personalized Trial Series %A Friel,Ciaran P %A Robles,Patrick L %A Butler,Mark %A Pahlevan-Ibrekic,Challace %A Duer-Hefele,Joan %A Vicari,Frank %A Chandereng,Thevaa %A Cheung,Ken %A Suls,Jerry %A Davidson,Karina W %+ Institute of Health System Science, Feinstein Institutes for Medical Research, Northwell Health, 140 East 59th Street, New York, NY, 10022, United States, 1 9172027729, cfriel@northwell.edu %K behavior change techniques %K N-of-1 %K personalized trials %K physical activity %K behavior change %K aging %K quality of life %K feasibility %K acceptability %K effectiveness %K web-based %K intervention %K text %K email %K survey %D 2023 %7 14.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Being physically active is critical to successful aging, but most middle-aged and older adults do not move enough. Research has shown that even small increases in activity can have a significant impact on risk reduction and improve quality of life. Some behavior change techniques (BCTs) can increase activity, but prior studies on their effectiveness have primarily tested them in between-subjects trials and in aggregate. These design approaches, while robust, fail to identify those BCTs most influential for a given individual. In contrast, a personalized, or N-of-1, trial design can assess a person’s response to each specific intervention. Objective: This study is designed to test the feasibility, acceptability, and preliminary effectiveness of a remotely delivered personalized behavioral intervention to increase low-intensity physical activity (ie, walking) in adults aged 45 to 75 years. Methods: The intervention will be administered over 10 weeks, starting with a 2-week baseline period followed by 4 BCTs (goal-setting, self-monitoring, feedback, and action planning) delivered one at a time, each for 2 weeks. In total, 60 participants will be randomized post baseline to 1 of 24 intervention sequences. Physical activity will be continuously measured by a wearable activity tracker, and intervention components and outcome measures will be delivered and collected by email, SMS text messages, and surveys. The effect of the overall intervention on step counts relative to baseline will be examined using generalized linear mixed models with an autoregressive model that accounts for possible autocorrelation and linear trends for daily steps across time. Participant satisfaction with the study components and attitudes and opinions toward personalized trials will be measured at the intervention's conclusion. Results: Pooled change in daily step count will be reported between baseline and individual BCTs and baseline versus overall intervention. Self-efficacy scores will be compared between baseline and individual BCTs and between baseline and the overall intervention. Mean and SD will be reported for survey measures (participant satisfaction with study components and attitudes and opinions toward personalized trials). Conclusions: Assessing the feasibility and acceptability of delivering a personalized, remote physical activity intervention for middle-aged and older adults will inform what steps will be needed to scale up to a fully powered and within-subjects experimental design remotely. Examining the effect of each BCT in isolation will allow for their unique impact to be assessed and support design of future behavioral interventions. In using a personalized trial design, the heterogeneity of individual responses for each BCT can be quantified and inform later National Institutes of Health stages of intervention development trials. Trial Registration: clinicaltrials.gov NCT04967313; https://clinicaltrials.gov/ct2/show/NCT04967313 International Registered Report Identifier (IRRID): RR1-10.2196/43418 %M 37314839 %R 10.2196/43418 %U https://www.researchprotocols.org/2023/1/e43418 %U https://doi.org/10.2196/43418 %U http://www.ncbi.nlm.nih.gov/pubmed/37314839 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41981 %T Coach-Supported Versus Self-guided Digital Training Course for a Problem-solving Psychological Intervention for Nonspecialists: Protocol for a Pre-Post Nested Randomized Controlled Trial %A Mathur,Sonal %A Weiss,Helen A %A Neuman,Melissa %A Field,Andy P %A Leurent,Baptiste %A Shetty,Tejaswi %A J,James E %A Nair,Pooja %A Mathews,Rhea %A Malik,Kanika %A Michelson,Daniel %A Patel,Vikram %+ Department of Global Health and Social Medicine, Harvard Medical School, 641, Huntington Avenue, Boston, MA, 02115, United States, 1 9822132038, vikram_patel@hms.harvard.edu %K adolescent mental health %K capacity building %K digital training %K India %K problem-solving intervention %K randomized controlled trial %D 2023 %7 13.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Psychosocial interventions delivered by nonspecialists can be effective at reducing common adolescent mental health problems in low-resource settings. However, there is a lack of evidence on resource-efficient methods for building capacity to deliver these interventions. Objective: The objective of this study is to evaluate the effects of a digital training (DT) course, delivered in a self-guided format or with coaching, on nonspecialists’ competency to deliver a problem-solving intervention intended for adolescents with common mental health problems in India. Methods: We will conduct a pre-post study with a nested parallel, 2-arm, individually randomized controlled trial. The study aims to recruit 262 participants, randomized 1:1 to receive either a self-guided DT course or a DT course with weekly individualized coaching provided remotely by telephone. In both arms, the DT will be accessed over 4 to 6 weeks. Participants will be nonspecialists (ie, without prior practice-based training in psychological therapies) recruited from among university students and affiliates of nongovernmental organizations in Delhi and Mumbai, India. Results: Outcomes will be assessed at baseline and 6 weeks post randomization using a knowledge-based competency measure that incorporates a multiple-choice quiz format. The primary hypothesis is that self-guided DT will lead to increased competency scores among novices with no prior experience of delivering psychotherapies. The secondary hypothesis is that digital training with coaching will have an incremental effect on competency scores compared with DT alone. The first participant was enrolled on April 4, 2022. Conclusions: The study will address an evidence gap on the effectiveness of training methods for nonspecialist providers of adolescent mental health interventions in low-resource settings. The findings from this study will be used to support wider efforts to scale up evidence-based mental health interventions for young people. Trial Registration: ClinicalTrials.gov NCT05290142; https://clinicaltrials.gov/ct2/show/NCT05290142 International Registered Report Identifier (IRRID): DERR1-10.2196/41981 %M 37310781 %R 10.2196/41981 %U https://www.researchprotocols.org/2023/1/e41981 %U https://doi.org/10.2196/41981 %U http://www.ncbi.nlm.nih.gov/pubmed/37310781 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45135 %T Efficacy of a Digital Mental Health Biopsychosocial Transdiagnostic Intervention With or Without Therapist Assistance for Adults With Anxiety and Depression: Adaptive Randomized Controlled Trial %A Andrews,Brooke %A Klein,Britt %A Van Nguyen,Huy %A Corboy,Denise %A McLaren,Suzanne %A Watson,Shaun %+ Health Innovation & Transformation Centre, Federation University Australia, University Drive, Mt Helen Victoria, Ballarat, 3350, Australia, 61 53279623 ext 9623, b.andrews@federation.edu.au %K video chat therapy %K therapist assistance %K self-help %K transdiagnostic %K digital intervention %K anxiety %K depression %K comorbidity %D 2023 %7 12.6.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital mental health (DMH) interventions incorporating elements that adapt to the evolving needs of consumers have the potential to further our understanding of the optimal intensity of therapist assistance and inform stepped-care models. Objective: The primary objective was to compare the efficacy of a transdiagnostic biopsychosocial DMH program, with or without therapist assistance for adults with subthreshold symptoms or a diagnosis of anxiety or depression. Methods: In a randomized adaptive clinical trial design, all participants had access to the DMH program, with eligibility to have their program augmented with therapist assistance determined by program engagement or symptom severity. Participants who met stepped-care criteria were randomized to have their treatment program augmented with either low-intensity (10 min/week of video chat support for 7 weeks) or high-intensity (50 min/week of video chat support for 7 weeks) therapist assistance. A total of 103 participants (mean age 34.17, SD 10.50 years) were assessed before (week 0), during (weeks 3 and 6), and after the intervention (week 9) and at the 3-month follow-up (week 21). The effects of 3 treatment conditions (DMH program only, DMH program+low-intensity therapist assistance, and DMH program+high-intensity therapist assistance) on changes in the 2 primary outcomes of anxiety (7-item Generalized Anxiety Disorder Scale [GAD-7]) and depression (9-item Patient Health Questionnaire [PHQ-9]) were assessed using the Cohen d, reliable change index, and mixed-effects linear regression analyses. Results: There were no substantial differences in the outcome measures among intervention conditions. However, there were significant time effect changes in most outcomes over time. All 3 intervention conditions demonstrated strong and significant treatment effect changes in GAD-7 and PHQ-9 scores, with absolute Cohen d values ranging from 0.82 to 1.79 (all P<.05). The mixed-effects models revealed that, in the Life Flex program–only condition at week 3, mean GAD-7 and PHQ-9 scores significantly decreased from baseline by 3.54 and 4.38 (all P<.001), respectively. At weeks 6, 9, and 21, GAD-7 and PHQ-9 scores significantly decreased from baseline by at least 6 and 7 points (all P<.001), respectively. Nonresponders at week 3 who were stepped up to therapist assistance increased program engagement and treatment response. At the postintervention time point and 3-month follow-up, 67% (44/65) and 69% (34/49) of the participants, respectively, no longer met diagnostic criteria for anxiety or depression. Conclusions: The findings highlight that early detection of low engagement and non–treatment response presents an opportunity to effectively intervene by incorporating an adaptive design. Although the study findings indicate that therapist assistance was no more effective than the DMH intervention program alone for reducing symptoms of anxiety or depression, the data highlight the potential influence of participant selection bias and participant preferences within stepped-care treatment models. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620000422921; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378317&isReview=true International Registered Report Identifier (IRRID): RR2-10.2196/45040 %M 37307046 %R 10.2196/45135 %U https://www.jmir.org/2023/1/e45135 %U https://doi.org/10.2196/45135 %U http://www.ncbi.nlm.nih.gov/pubmed/37307046 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e42349 %T Implementing a Digital Depression Prevention Program in Australian Secondary Schools: Cross-Sectional Qualitative Study %A Beames,Joanne R %A Werner-Seidler,Aliza %A Hodgins,Michael %A Brown,Lyndsay %A Fujimoto,Hiroko %A Bartholomew,Alexandra %A Maston,Kate %A Huckvale,Kit %A Zbukvic,Isabel %A Torok,Michelle %A Christensen,Helen %A Batterham,Philip J %A Calear,Alison L %A Lingam,Raghu %A Boydell,Katherine M %+ Black Dog Institute, University of New South Wales, Hospital Road, Sydney, NSW, 2031, Australia, 61 02 9382 ext 4530, z3330693@zmail.unsw.edu.au %K implementation %K youth %K digital %K depression %K secondary school %K qualitative %K consolidated framework for implementation research %K teacher %K educator %K perspective %K mental health %K student %K child %K adolescent %K adolescence %K school %K social work %D 2023 %7 12.6.2023 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Depression is common during adolescence and is associated with adverse educational, employment, and health outcomes in later life. Digital programs are increasingly being implemented in schools to improve and protect adolescent mental health. Although digital depression prevention programs can be effective, there is limited knowledge about how contextual factors influence real-world delivery at scale in schools. Objective: The purpose of this study was to examine the contextual factors that influence the implementation of the Future Proofing Program (FPP) from the perspectives of school staff. The FPP is a 2-arm hybrid type 1 effectiveness-implementation trial evaluating whether depression can be prevented at scale in schools, using an evidence-based smartphone app delivered universally to year 8 students (13-14 years of age). Methods: Qualitative interviews were conducted with 23 staff from 20 schools in New South Wales, Australia, who assisted with the implementation of the FPP. The interviews were guided by our theory-driven logic model. Reflexive thematic analysis, using both deductive and inductive coding, was used to analyze responses. Results: Staff perceived the FPP as a novel (“innovative approach”) and appropriate way to address an unmet need within schools (“right place at the right time”). Active leadership and counselor involvement were critical for planning and engaging; teamwork, communication, and staff capacity were critical for execution (“ways of working within schools”). Low student engagement and staffing availability were identified as barriers for future adoption and implementation by schools (“reflecting on past experiences”). Conclusions: Four superordinate themes pertaining to the program, implementation processes, and implementation barriers were identified from qualitative responses by school staff. On the basis of our findings, we proposed a select set of recommendations for future implementation of digital prevention programs delivered at scale in schools. These recommendations were designed to facilitate an organizational change and help staff to implement digital mental health programs within their schools. International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2020-042133 %M 37307051 %R 10.2196/42349 %U https://pediatrics.jmir.org/2023/1/e42349 %U https://doi.org/10.2196/42349 %U http://www.ncbi.nlm.nih.gov/pubmed/37307051 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 9 %N %P e40113 %T Therapist Feedback and Implications on Adoption of an Artificial Intelligence–Based Co-Facilitator for Online Cancer Support Groups: Mixed Methods Single-Arm Usability Study %A Leung,Yvonne W %A Ng,Steve %A Duan,Lauren %A Lam,Claire %A Chan,Kenith %A Gancarz,Mathew %A Rennie,Heather %A Trachtenberg,Lianne %A Chan,Kai P %A Adikari,Achini %A Fang,Lin %A Gratzer,David %A Hirst,Graeme %A Wong,Jiahui %A Esplen,Mary Jane %+ de Souza Institute, University Health Network, 222 St Patrick Street, Suite 503, Toronto, ON, M5T 1V4, Canada, 1 844 758 6891, yw.leung@utoronto.ca %K cancer %K recommender system %K natural language processing %K LIWC %K natural language processing %K emotion analysis %K therapist adoption %K therapist attitudes %K legal implications of AI %K therapist liability %D 2023 %7 9.6.2023 %9 Original Paper %J JMIR Cancer %G English %X Background: The recent onset of the COVID-19 pandemic and the social distancing requirement have created an increased demand for virtual support programs. Advances in artificial intelligence (AI) may offer novel solutions to management challenges such as the lack of emotional connections within virtual group interventions. Using typed text from online support groups, AI can help identify the potential risk of mental health concerns, alert group facilitator(s), and automatically recommend tailored resources while monitoring patient outcomes. Objective: The aim of this mixed methods, single-arm study was to evaluate the feasibility, acceptability, validity, and reliability of an AI-based co-facilitator (AICF) among CancerChatCanada therapists and participants to monitor online support group participants’ distress through a real-time analysis of texts posted during the support group sessions. Specifically, AICF (1) generated participant profiles with discussion topic summaries and emotion trajectories for each session, (2) identified participant(s) at risk for increased emotional distress and alerted the therapist for follow-up, and (3) automatically suggested tailored recommendations based on participant needs. Online support group participants consisted of patients with various types of cancer, and the therapists were clinically trained social workers. Methods: Our study reports on the mixed methods evaluation of AICF, including therapists’ opinions as well as quantitative measures. AICF’s ability to detect distress was evaluated by the patient's real-time emoji check-in, the Linguistic Inquiry and Word Count software, and the Impact of Event Scale-Revised. Results: Although quantitative results showed only some validity of AICF’s ability in detecting distress, the qualitative results showed that AICF was able to detect real-time issues that are amenable to treatment, thus allowing therapists to be more proactive in supporting every group member on an individual basis. However, therapists are concerned about the ethical liability of AICF’s distress detection function. Conclusions: Future works will look into wearable sensors and facial cues by using videoconferencing to overcome the barriers associated with text-based online support groups. International Registered Report Identifier (IRRID): RR2-10.2196/21453 %M 37294610 %R 10.2196/40113 %U https://cancer.jmir.org/2023/1/e40113 %U https://doi.org/10.2196/40113 %U http://www.ncbi.nlm.nih.gov/pubmed/37294610 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e42114 %T Adaptation of a Mobile Interactive Obesity Treatment Approach for Early Severe Mental Illness: Protocol for a Mixed Methods Implementation and Pilot Randomized Controlled Trial %A Nicol,Ginger E %A Jansen,Madeline O %A Ricchio,Amanda R %A Schweiger,Julia A %A Keenoy,Katie E %A Miller,J Philip %A Morrato,Elaine H %A Guo,Zhaohua %A Evanoff,Bradley A %A Parks,Joseph J %A Newcomer,John W %+ Department of Psychiatry, Washington University School of Medicine, Washington University in St. Louis, 600 S Taylor Ave, Suite 121, Saint Louis, MO, 63110, United States, 1 3143625154, nicolg@wustl.edu %K community mental health services %K implementation science %K mental disorders %K obesity %K primary prevention %D 2023 %7 9.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Obesity is common in individuals with severe mental illness (SMI), contributing to a significantly shortened lifespan when compared to the general population. Available weight loss treatments have attenuated efficacy in this population, underscoring the importance of prevention and early intervention. Objective: Here, we describe a type 1 hybrid study design for adapting and pilot-testing an existing mobile health intervention for obesity prevention in individuals with early SMI and Class I or early-stage obesity, defined as a BMI of 30-35. Methods: An existing, evidence-based interactive obesity treatment approach using low-cost, semiautomated SMS text messaging was selected for adaptation. Community mental health clinics and Clubhouse settings in Eastern Missouri and South Florida were identified to participate. This study has the following 3 aims. First, using the Enhanced Framework for Reporting Adaptations and Modifications to Evidence-based interventions, contextual aspects of the clinical and digital treatment environments are identified for adaptation, considering 5 main stakeholder groups (clinical administrators, prescribing clinicians, case managers, nurses, and patients). Following a 2-week trial of unadapted SMS text messaging, Innovation Corps methods are used to discover needed intervention adaptations by stakeholder group and clinical setting. Second, adaptations to digital functionality and intervention content will be made based on themes identified in aim 1, followed by rapid usability testing with key stakeholders. A process for iterative treatment adaptation will be developed for making unplanned modifications during the aim 3 implementation pilot study. Individuals working in partner community mental health clinics and Clubhouse settings will be trained in intervention delivery. Third, in a randomized pilot and feasibility trial, adults with 5 years or less of treatment for an SMI diagnosis will be randomized 2:1 to 6 months of an adapted interactive obesity treatment approach or to an attentional control condition, followed by a 3-month extension phase of SMS text messages only. Changes in weight, BMI, and behavioral outcomes, as well as implementation challenges, will be evaluated at 6 and 9 months. Results: Institutional review board approval for aims 1 and 2 was granted on August 12, 2018, with 72 focus group participants enrolled; institutional review board approval for aim 3 was granted on May 6, 2020. To date, 52 participants have been enrolled in the study protocol. Conclusions: In this type 1 hybrid study design, we apply an evidence-based treatment adaptation framework to plan, adapt, and feasibility test a mobile health intervention in real-world treatment settings. Resting at the intersection of community mental health treatment and physical health promotion, this study aims to advance the use of simple technology for obesity prevention in individuals with early-stage mental illness. Trial Registration: ClinicalTrials.gov NCT03980743; https://clinicaltrials.gov/ct2/show/NCT03980743 International Registered Report Identifier (IRRID): DERR1-10.2196/42114 %M 37294604 %R 10.2196/42114 %U https://www.researchprotocols.org/2023/1/e42114 %U https://doi.org/10.2196/42114 %U http://www.ncbi.nlm.nih.gov/pubmed/37294604 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e40111 %T Feasibility and Acceptability of the Aboriginal and Islander Mental Health Initiative for Youth App: Nonrandomized Pilot With First Nations Young People %A Dingwall,Kylie M %A Povey,Josie %A Sweet,Michelle %A Friel,Jaylene %A Shand,Fiona %A Titov,Nickolai %A Wormer,Julia %A Mirza,Tamoor %A Nagel,Tricia %+ Menzies School of Health Research, Charles Darwin University, PO Box 795, Alice Springs, 0871, Australia, 61 889595380, kylie.dingwall@menzies.edu.au %K digital mental health %K First Nations %K Indigenous %K young people %K feasibility study %K digital health %K mental health %K depression %K mHealth %K mobile app %K aboriginal %K acceptibility %K youth %D 2023 %7 7.6.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Despite young First Nations Australians being typically healthy, happy, and connected to family and culture, high rates of emotional distress, suicide, and self-harm are also observed. Differing worldviews of service providers and First Nations young people regarding illness and treatment practices, language differences, culturally inappropriate service models, geographical remoteness, and stigma can all inhibit access to appropriate mental health support. Mental health treatments delivered digitally (digital mental health; dMH) offer flexible access to evidence-based, nonstigmatizing, low-cost treatment and early intervention on a broad scale. There is a rapidly growing use and acceptance of these technologies among young First Nations people. Objective: The objective was to assess the feasibility, acceptability, and use of the newly developed Aboriginal and Islander Mental Health Initiative for Youth (AIMhi-Y) app and determine the feasibility of study procedures in preparation for future assessments of effectiveness. Methods: This was a nonrandomized pre-post study using mixed methods. First Nations young people aged 12-25 years who provided consent (with parental consent where appropriate) and possessed the ability to navigate a simple app with basic English literacy were included. Researchers conducted one face-to-face 20-minute session with participants to introduce and orient them to the AIMhi-Y app. The app integrates culturally adapted low-intensity cognitive behavioral therapy (CBT), psychoeducation, and mindfulness-based activities. Participants received supportive text messages weekly throughout the 4-week intervention period and completed assessments of psychological distress, depression, anxiety, substance misuse, help-seeking, service use, and parent-rated strengths and difficulties at baseline and 4 weeks. Qualitative interviews and rating scales were completed at 4 weeks to gain feedback on subjective experience, look and style, content, overall rating, check-ins, and involvement in the study. App use data were collected. Results: Thirty young people (17 males and 13 females) aged between 12 and 18 (mean 14.0, SD 1.55) years were assessed at baseline and 4 weeks. Repeated measures 2-tailed t tests showed improvements in well-being measures that were statistically and clinically significant for psychological distress (Kessler Psychological Distress Scale, 10-item) and depressive symptoms (Patient Health Questionnaire, 2-item). Participants spent on average 37 minutes in the app. The app was rated positively, with mean ratings of 4 out of 5 points (on scales of 1-5). Participants reported that they found the app easy to use, culturally relevant, and useful. The feasibility of the study was demonstrated with a 62% recruitment rate, a 90% retention rate, and high study acceptability ratings. Conclusions: This study supports earlier research suggesting that dMH apps that are appropriately designed with and for the target populations are a feasible and acceptable means of lowering symptoms for mental health disorders among First Nations youth. %M 37285184 %R 10.2196/40111 %U https://humanfactors.jmir.org/2023/1/e40111 %U https://doi.org/10.2196/40111 %U http://www.ncbi.nlm.nih.gov/pubmed/37285184 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43036 %T An Entertainment-Education Video and Written Messages to Alleviate Loneliness in Germany: Pilot Randomized Controlled Study %A Liu,Shuyan %A Wegner,Luisa %A Haucke,Matthias %A Gates,Jennifer %A Adam,Maya %A Bärnighausen,Till %+ Heidelberg Institute of Global Health, Im Neuenheimer Feld 130.3, Heidelberg, 69120, Germany, 49 622156534, till.baernighausen@uni-heidelberg.de %K entertainment media %K perceived social isolation %K health communication %K digital knowledge %D 2023 %7 7.6.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: More than half of adults in Germany have felt lonely during the COVID-19 pandemic. Previous studies highlight the importance of boosting positive emotions and social connectedness to combat loneliness. However, interventions targeting these protective psychosocial resources remain largely untested. Objective: In this study, we aim to test the feasibility of a short animated storytelling video, written messages boosting social connectedness, and a combination of both for alleviating loneliness. Methods: We enrolled 252 participants who were 18 years or older and spoke fluent German. Participants were recruited from a previous study on loneliness in Germany. We measured the effects of a combination of an animated video and written messages (intervention A), an animated video (intervention B), and written messages (intervention C) on loneliness, self-esteem, self-efficacy, and hope. We compared these with a control arm, which did not receive any intervention. The animated video was developed by Stanford University School of Medicine to reflect experiences of social isolation during the COVID-19 pandemic and convey messages of hope and solidarity. The written messages communicate four findings from recent studies on loneliness in Germany: (1) over a period of 6 months, 66% of respondents in Germany reported feeling lonely (feelings of loneliness are surprisingly common); (2) physical activity can ease feelings of loneliness; (3) focusing on “what really matters” in one’s life can help to ease feelings of loneliness; and (4) turning to friends for companionship and support can ease feelings of loneliness. Participants were randomized 1:1:1:1 to interventions A, B, C, and the control condition, using the randomization feature of the web-based platform “Unipark,” on which our trial takes place. Both the study investigators and analysts were blinded to the trial assignments. The primary outcome, loneliness, was measured using the short-form UCLA Loneliness Scale (ULS-8). Our secondary outcomes included the scores of the Coping with Loneliness Questionnaire, the 10-item Rosenberg Self-Esteem Scale (RSE), the 10-item General Self-Efficacy Scale, and the 12-item Adult Hope Scale (AHS). Results: We observed no statistically significant effect of the tested interventions on loneliness scores, controlling for the baseline loneliness score before an intervention (all P values >.11). However, we observed significantly greater intention to cope with loneliness after exposure to an animated video when compared with the control (β=4.14; t248=1.74; 1-tailed P=.04). Conclusions: Our results provide meaningful evidence for the feasibility of a full-scale study. Our study sheds light on the intention to cope with loneliness and explores the potential for creative digital interventions to enhance this psychological precursor, which is integral to overcoming loneliness. Trial Registration: German Clinical Trials Register DRKS00027116; https://drks.de/search/en/trial/DRKS00027116 %M 37285206 %R 10.2196/43036 %U https://formative.jmir.org/2023/1/e43036 %U https://doi.org/10.2196/43036 %U http://www.ncbi.nlm.nih.gov/pubmed/37285206 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41890 %T Internet-Delivered Dialectical Behavioral Therapy Skills Training for Chronic Pain: Protocol for a Randomized Controlled Trial %A Norman-Nott,Nell %A Hesam-Shariati,Negin %A Wilks,Chelsey R %A Schroeder,Jessica %A Suh,Jina %A Briggs,Nancy E %A McAuley,James H %A Quidé,Yann %A Gustin,Sylvia M %+ NeuroRecovery Research Hub, School of Psychology, University of New South Wales, BioLink Building, Level 1, High Street, Kensington, Sydney, 2052, Australia, 61 293480846, n.normannott@unsw.edu.au %K internet-delivered %K dialectical behavioral therapy %K chronic pain %K emotion dysregulation %K emotion-centric intervention %K mobile phone %D 2023 %7 7.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Emotion dysregulation is key to the development and maintenance of chronic pain, feeding into a cycle of worsening pain and disability. Dialectical behavioral therapy (DBT), an evidence-based treatment for complex transdiagnostic conditions presenting with high emotion dysregulation, may be beneficial to manage and mitigate the emotional and sensory aspects of chronic pain. Increasingly, DBT skills training as a key component of standard DBT is being delivered as a stand-alone intervention without concurrent therapy to help develop skills for effective emotion regulation. A previous repeated-measure single-case trial investigating a novel technologically driven DBT skills training, internet-delivered DBT skills training for chronic pain (iDBT-Pain), revealed promising findings to improve both emotion dysregulation and pain intensity. Objective: This randomized controlled trial aims to examine the efficacy of iDBT-Pain in comparison with treatment as usual to reduce emotion dysregulation (primary outcome) for individuals with chronic pain after 9 weeks and at the 21-week follow-up. The secondary outcomes include pain intensity, pain interference, anxiety symptoms, depressive symptoms, perceived stress, posttraumatic stress, harm avoidance, social cognition, sleep quality, life satisfaction, and well-being. The trial also examines the acceptability of the iDBT-Pain intervention for future development and testing. Methods: A total of 48 people with chronic pain will be randomly assigned to 1 of 2 conditions: treatment and treatment as usual. Participants in the treatment condition will receive iDBT-Pain, consisting of 6 live web-based group sessions led by a DBT skills trainer and supervised by a registered psychologist and the iDBT-Pain app. Participants in the treatment-as-usual condition will not receive iDBT-Pain but will still access their usual medication and health interventions. We predict that iDBT-Pain will improve the primary outcome of emotion dysregulation and the secondary outcomes of pain intensity, pain interference, anxiety symptoms, depressive symptoms, perceived stress, harm avoidance, social cognition, sleep quality, life satisfaction, and well-being. A linear mixed model with random effects of individuals will be conducted to investigate the differences between the baseline, 9-week (primary end point), and 21-week (follow-up) assessments as a function of experimental condition. Results: Recruitment started in February 2023, and the clinical trial started in March 2023. Data collection for the final assessment is planned to be completed by July 2024. Conclusions: If our hypothesis is confirmed, our findings will contribute to the evidence for the efficacy and acceptability of a viable intervention that may be used by health care professionals for people with chronic pain. The results will add to the chronic pain literature to inform about the potential benefits of DBT skills training for chronic pain and will contribute evidence about technologically driven interventions. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12622000113752; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383208&isReview=true International Registered Report Identifier (IRRID): PRR1-10.2196/41890 %M 37285187 %R 10.2196/41890 %U https://www.researchprotocols.org/2023/1/e41890 %U https://doi.org/10.2196/41890 %U http://www.ncbi.nlm.nih.gov/pubmed/37285187 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45234 %T Promoting Engagement With Smartphone Apps for Suicidal Ideation in Young People: Development of an Adjunctive Strategy Using a Lived Experience Participatory Design Approach %A Gan,Daniel Z Q %A McGillivray,Lauren %A Larsen,Mark Erik %A Bloomfield,Taylor %A Torok,Michelle %+ Black Dog Institute, University of New South Wales, Hospital Road, Sydney, NSW 2031, Australia, 61 423828945, danielzqgan@gmail.com %K eHealth %K digital mental health %K smartphone app %K engagement %K youth suicide prevention %K qualitative methods %K suicide %K development %K youth %K mental health %K support %K user-centered %K design %K survey %K interview %K prototype %K prevention %K participatory design %K mobile phone %D 2023 %7 6.6.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Suicide among young people is a worrying public health concern. Despite this, there is a lack of suitable interventions aligned with the needs of this priority population. Emerging evidence supports the effectiveness of digital interventions in alleviating the severity of suicidal thoughts. However, their efficacy may be undermined by poor engagement. Technology-supported strategies (eg, electronic prompts and reminders) have been deployed alongside digital interventions to increase engagement with the latter. However, evidence of their efficacy is inconclusive. User-centered design approaches may be key to developing feasible and effective engagement strategies. Currently, no study has been published on how such an approach might be expressly applied toward developing strategies for promoting engagement with digital interventions. Objective: This study aimed to detail the processes and activities involved in developing an adjunctive strategy for promoting engagement with LifeBuoy—a smartphone app that helps young people manage suicidal thoughts. Methods: Development of the engagement strategy took place in 2 phases. The discovery phase aimed to create an initial prototype by synthesizing earlier findings—from 2 systematic reviews and a cross-sectional survey of the broader mental health app user population—with qualitative insights from LifeBuoy users. A total of 16 web-based interviews were conducted with young people who participated in the LifeBuoy trial. Following the discovery phase, 3 interviewees were invited by the research team to take part in the workshops in the design phase, which sought to create a final prototype by making iterative improvements to the initial prototype. These improvements were conducted over 2 workshops. Thematic analysis was used to analyze the qualitative data obtained from the interviews and workshops. Results: Main themes from the interviews centered around the characteristics of the strategy, timing of notifications, and suitability of social media platforms. Subsequently, themes that emerged from the design workshops emphasized having a wider variety of content, greater visual consistency with LifeBuoy, and a component with more detailed information to cater to users with greater informational needs. Thus, refinements to the prototype were focused on (1) improving the succinctness, variety, and practical value of Instagram content, (2) creating a blog containing articles contributed by mental health professionals and young people with lived experience of suicide, and (3) standardizing the use of marine-themed color palettes across the Instagram and blog components. Conclusions: This is the first study to describe the development of a technology-supported adjunctive strategy for promoting engagement with a digital intervention. It was developed by integrating perspectives from end users with lived experience of suicide with evidence from the existing literature. The development process documented in this study may be useful for guiding similar projects aimed at supporting the use of digital interventions for suicide prevention or mental health. %M 37279058 %R 10.2196/45234 %U https://formative.jmir.org/2023/1/e45234 %U https://doi.org/10.2196/45234 %U http://www.ncbi.nlm.nih.gov/pubmed/37279058 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e45531 %T Improving Kidney Outcomes in Patients With Nondiabetic Chronic Kidney Disease Through an Artificial Intelligence–Based Health Coaching Mobile App: Retrospective Cohort Study %A Liu,Wei %A Yu,Xiaojuan %A Wang,Jiangyuan %A Zhou,Tianmeng %A Yu,Ting %A Chen,Xuyong %A Xie,Shasha %A Han,Fuman %A Wang,Zi %+ Renal Division, Department of Medicine, Peking University First Hospital, No. 8. Xishiku Street, Xicheng District, Beijing, 100034, China, 86 01083575685, tonypedia@126.com %K chronic kidney disease %K self-management %K mobile apps %K end-stage kidney disease %K eHealth intervention %K kidney %K efficacy %K eHealth care %K dialysis %K deep-learning %K artificial intelligence %K patient care %D 2023 %7 1.6.2023 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Chronic kidney disease (CKD) is a global health burden. However, the efficacy of different modes of eHealth care in facilitating self-management for patients with CKD is unclear. Objective: The aim of this study was to evaluate the effectiveness of a mobile app–based intelligent care system in improving the kidney outcomes of patients with CKD. Methods: Our study was a retrospective analysis based on the KidneyOnline intelligent system developed in China. Patients with CKD but not dependent on dialysis who registered on the KidneyOnline app between January 2017 and January 2021 were screened. Patients in the the KidneyOnline intelligent system group and those in the conventional care group were 1:1 matched according to their baseline characteristics. The intervention group received center-based follow-up combined with the KidneyOnline intelligent patient care system, which was a nurse-led, patient-oriented collaborative management system. Health-related data uploaded by the patients were integrated using deep learning optical character recognition (OCR). Artificial intelligence (AI)–generated personalized recipes, lifestyle intervention suggestions, early warnings, real-time questions and answers, and personalized follow-up plans were also provided. Patients in the conventional group could get professional suggestions from the nephrologists through regular clinical visits, but they did not have access to the service provided by AI and the health coach team. Patients were followed for at least 3 months after recruitment or until death or start of renal replacement therapy. Results: A total of 2060 eligible patients who registered on the KidneyOnline app from 2017 to 2021 were enrolled for the analysis. Of those, 902 (43.8%) patients were assessed for survival analysis after propensity score matching, with 451(50%) patients in the KidneyOnline intelligent patient care system group and 451(50%) patients in the conventional care group. After a mean follow-up period of 15.8 (SD 9.5) months, the primary composite kidney outcome occurred in 28 (6%) participants in the KidneyOnline intelligent patient care system group and 32 (7%) in the conventional care group, with a hazard ratio of 0.391 (95% CI 0.231-0.660; P<.001). Subgroup survival analysis demonstrated that the KidneyOnline care system significantly reduced the risk of composite kidney outcome, irrespective of age, sex, baseline estimated glomerular filtration rate (eGFR), and proteinuria. In addition, the mean arterial pressure (MAP) significantly decreased from 88.9 (SD 10.5) mmHg at baseline to 85.6 (SD 7.9) mmHg at 6 months (P<.001) in the KidneyOnline intelligent patient care system group and from 89.3 (SD 11.1) mmHg to 87.5 (SD 8.2) mmHg (P=.002) in the conventional CKD care group. Conclusions: The utilization of the KidneyOnline intelligent care system was associated with reduced risk of unfavorable kidney outcomes in nondiabetic patients with CKD. %M 37261895 %R 10.2196/45531 %U https://mhealth.jmir.org/2023/1/e45531 %U https://doi.org/10.2196/45531 %U http://www.ncbi.nlm.nih.gov/pubmed/37261895 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 11 %N %P e44132 %T Effectiveness of Digital Health Interventions Containing Game Components for the Self-management of Type 2 Diabetes: Systematic Review %A Ossenbrink,Linda %A Haase,Tina %A Timpel,Patrick %A Schoffer,Olaf %A Scheibe,Madlen %A Schmitt,Jochen %A Deckert,Stefanie %A Harst,Lorenz %+ Center for Evidence-based Healthcare, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, Dresden, 01307, Germany, 49 37133335325, lorenz.harst@tu-dresden.de %K diabetes %K gamification %K digital health %K diabetes self-management %K mobile phone %D 2023 %7 1.6.2023 %9 Review %J JMIR Serious Games %G English %X Background: Games and game components have become a major trend in the realm of digital health research and practice as they are assumed to foster behavior change and thereby improve patient-reported and clinical outcomes for patients with type 2 diabetes. Objective: The aim of this systematic review was to summarize and evaluate the current evidence on the effectiveness of digital health interventions containing game components on behavioral, patient-reported, and clinical outcomes for patients with type 2 diabetes. Methods: An electronic search was conducted in MEDLINE and PsycINFO in April 2020; updated in April 2022; and supplemented by additional searches via Google Scholar, Web of Science (which was used for forward citation tracking), and within the references of the included records. Articles were identified using predefined inclusion and exclusion criteria. In total, 2 reviewers independently conducted title, abstract, and full-text screening and then individually performed a critical appraisal of all the included studies using the Cochrane risk-of-bias tool version 2. A consensus was reached through discussion. Results: Of 2325 potentially relevant titles (duplicates excluded), 10 (0.43%) randomized controlled trials were included in this review. Quality assessment revealed a high risk of bias for all randomized controlled trials except for 10% (1/10), with performance bias due to the lack of blinding being the major source of bias. There is evidence suggesting that digital health interventions containing game components can substantially improve motivation for physical activity (1/1, 100% of the studies dealing with PA motivation), exercise intensity (3/5, 60%), dietary behavior (4/4, 100%), health literacy (1/3, 33%), mental quality of life (2/2, 100%), glycated hemoglobin level (2/6, 33%), BMI (1/3, 33%), fasting plasma glucose level (1/2, 50%), waist circumference (1/1, 100%), and aerobic capacity (1/1, 100%). Conclusions: Published studies indicated that digital health interventions containing game components might improve health behavior patterns, quality of life, and clinical outcomes in patients with type 2 diabetes. However, the intervention types and outcomes studied were heterogeneous, and study quality was mostly low, which translates to ambiguous results. Future research should focus on sound methodology and reporting as well as on identifying game components that contribute to significant positive effects. Trial Registration: PROSPERO CRD42020209706; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=209706 %M 37261900 %R 10.2196/44132 %U https://games.jmir.org/2023/1/e44132 %U https://doi.org/10.2196/44132 %U http://www.ncbi.nlm.nih.gov/pubmed/37261900 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 9 %N %P e45432 %T Engaging Men of Diverse Racial and Ethnic Groups With Advanced Prostate Cancer in the Design of an mHealth Diet and Exercise Intervention: Focus Group Study %A Wang,Elizabeth Y %A Borno,Hala T %A Washington III,Samuel L %A Friedlander,Terence %A Zhang,Sylvia %A Trejo,Evelin %A Van Blarigan,Erin L %A Chan,June M %A Shariff-Marco,Salma %A Beatty,Alexis L %A Kenfield,Stacey A %+ Department of Urology, University of California, San Francisco, 6th Floor, 550 16th Street, San Francisco, CA, 94158, United States, 1 415 476 5392, stacey.kenfield@ucsf.edu %K cancer survivorship %K digital health %K technology-based intervention %K modifiable behaviors %K metastatic %K androgen deprivation therapy %K race and ethnicity %K social determinants of health %K mobile phone %D 2023 %7 1.6.2023 %9 Original Paper %J JMIR Cancer %G English %X Background: Healthy diet and exercise can improve quality of life and prognosis among men with prostate cancer. Understanding the perceived barriers to lifestyle change and patient preferences in a diverse cohort of men with prostate cancer is necessary to inform mobile health (mHealth) lifestyle interventions and increase health equity. Objective: We conducted a multisite study to understand the preferences, attitudes, and health behaviors related to diet and lifestyle in this patient population. This report focuses on the qualitative findings from 4 web-based focus groups comprising a racially and ethnically diverse group of patients with advanced prostate cancer who are on androgen deprivation therapy. Methods: We used grounded theory analyses including open, axial, and selective coding to generate codes. Qualitative data were analyzed as a whole rather than by focus group to optimize data saturation and the transferability of results. We present codes and themes that emerged for lifestyle intervention design and provide recommendations and considerations for future mHealth intervention studies. Results: Overall, 14 men participated in 4 racially and ethnically concordant focus groups (African American or Black: 3/14, 21%; Asian American: 3/14, 21%; Hispanic or Latino: 3/14, 21%; and White: 5/14, 36%). Analyses converged on 7 interwoven categories: context (home environment, access, competing priorities, and lifestyle programs), motivation (accountability, discordance, feeling supported, fear, and temptation), preparedness (health literacy, technological literacy, technological preferences, trust, readiness to change, identity, adaptability, and clinical characteristics), data-driven design (education, psychosocial factors, and quality of life), program mechanics (communication, materials, customization, and being holistic), habits (eg, dietary habits), and intervention impressions. These results suggest actionable pathways to increase program intuitiveness. Recommendations for future mHealth intervention design and implementation include but are not limited to assessment at the individual, household, and neighborhood levels to support a tailored intervention; prioritization of information to disseminate based on individuals’ major concerns and the delivery of information based on health and technological literacy and communication preferences; prescribing a personalized intervention based on individuals’ baseline responses, home and neighborhood environment, and support network; and incorporating strategies to foster engagement (eg, responsive and relevant feedback systems) to aid participant decision-making and behavior change. Conclusions: Assessing a patient’s social context, motivation, and preparedness is necessary when tailoring a program to each patient’s needs in all racial and ethnic groups. Addressing the patients’ contexts and motivation and preparedness related to diet and exercise including the household, access (to food and exercise), competing priorities, health and technological literacy, readiness to change, and clinical characteristics will help to customize the intervention to the participant. These data support a tailored approach leveraging the identified components and their interrelationships to ensure that mHealth lifestyle interventions will engage and be effective in racially and ethnically diverse patients with cancer. Trial Registration: ClinicalTrials.gov NCT05324098; https://clinicaltrials.gov/ct2/show/NCT05324098 %M 37261885 %R 10.2196/45432 %U https://cancer.jmir.org/2023/1/e45432 %U https://doi.org/10.2196/45432 %U http://www.ncbi.nlm.nih.gov/pubmed/37261885 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44673 %T Skill Enactment and Knowledge Acquisition in Digital Cognitive Behavioral Therapy for Depression and Anxiety: Systematic Review of Randomized Controlled Trials %A Jackson,Hayley M %A Calear,Alison L %A Batterham,Philip J %A Ohan,Jeneva L %A Farmer,Glenda M %A Farrer,Louise M %+ Centre for Mental Health Research, National Centre for Epidemiology and Population Health, The Australian National University, 63 Eggleston Road, Acton ACT, 2601, Australia, 61 416913323, hayley.jackson@anu.edu.au %K cognitive behavioral therapy %K technology %K engagement %K skill enactment %K knowledge acquisition %K depression %K anxiety %K adults %K young people %K systematic review %K mobile phone %D 2023 %7 31.5.2023 %9 Review %J J Med Internet Res %G English %X Background: Digital cognitive behavioral therapy (CBT) interventions can effectively prevent and treat depression and anxiety, but engagement with these programs is often low. Although extensive research has evaluated program use as a proxy for engagement, the extent to which users acquire knowledge and enact skills from these programs has been largely overlooked. Objective: This study aimed to investigate how skill enactment and knowledge acquisition have been measured, evaluate postintervention changes in skill enactment and knowledge acquisition, examine whether mental health outcomes are associated with skill enactment or knowledge acquisition, and evaluate predictors of skill enactment and knowledge acquisition. Methods: PubMed, PsycINFO, and Cochrane CENTRAL were searched for randomized controlled trials (RCTs) published between January 2000 and July 2022. We included RCTs comparing digital CBT with any comparison group in adolescents or adults (aged ≥12 years) for anxiety or depression. Eligible studies reported quantitative measures of skill enactment or knowledge acquisition. The methodological quality of the studies was assessed using the Joanna Briggs Institute Critical Appraisal Checklist for RCTs. Narrative synthesis was used to address the review questions. Results: In total, 43 papers were included, of which 29 (67%) reported a skill enactment measure and 15 (35%) reported a knowledge acquisition measure. Skill enactment was typically operationalized as the frequency of enacting skills using the completion of in-program activities (ie, formal skill enactment; 13/29, 45%) and intervention-specific (9/29, 31%) or standardized (8/29, 28%) questionnaires. Knowledge measures included tests of CBT knowledge (6/15, 40%) or mental health literacy (5/15, 33%) and self-report questionnaires (6/15, 40%). In total, 17 studies evaluated postintervention changes in skill enactment or knowledge acquisition, and findings were mostly significant for skill enactment (6/8, 75% of the studies), CBT knowledge (6/6, 100%), and mental health literacy (4/5, 80%). Of the 12 studies that evaluated the association between skill enactment and postintervention mental health outcomes, most reported ≥1 significant positive finding on standardized questionnaires (4/4, 100%), formal skill enactment indicators (5/7, 71%), or intervention-specific questionnaires (1/1, 100%). None of the 4 studies that evaluated the association between knowledge acquisition and primary mental health outcomes reported significant results. A total of 13 studies investigated predictors of skill enactment; only type of guidance and improvements in psychological variables were associated with increased skill enactment in ≥2 analyses. Predictors of knowledge acquisition were evaluated in 2 studies. Conclusions: Digital CBT for depression and anxiety can improve skill enactment and knowledge acquisition. However, only skill enactment appears to be associated with mental health outcomes, which may depend on the type of measure examined. Additional research is needed to understand what types and levels of skill enactment and knowledge acquisition are most relevant for outcomes and identify predictors of these constructs. Trial Registration: PROSPERO CRD42021275270; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=275270 %M 37256673 %R 10.2196/44673 %U https://www.jmir.org/2023/1/e44673 %U https://doi.org/10.2196/44673 %U http://www.ncbi.nlm.nih.gov/pubmed/37256673 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43132 %T Adaptive Content Tuning of Social Network Digital Health Interventions Using Control Systems Engineering for Precision Public Health: Cluster Randomized Controlled Trial %A Rocha,Paulo %A Pinheiro,Diego %A de Paula Monteiro,Rodrigo %A Tubert,Ela %A Romero,Erick %A Bastos-Filho,Carmelo %A Nuno,Miriam %A Cadeiras,Martin %+ Division of Cardiovascular Medicine, Department of Internal Medicine, University of California, Davis, 4860 Y Street, ACC Building Suite 2820, Sacramento, CA, 94817, United States, 1 916 734 1546, phrocha@ucdavis.edu %K psychosocial intervention %K social network %K SNI %K social network intervention %K precision medicine %K precision public health %K organ donation %K organ procurement %K public awareness %K social media %K systems analysis %K tissue and organ procurement %K adaptive clinical trial %K proportional integral derivative %K patient education %K digital health %D 2023 %7 31.5.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Social media has emerged as an effective tool to mitigate preventable and costly health issues with social network interventions (SNIs), but a precision public health approach is still lacking to improve health equity and account for population disparities. Objective: This study aimed to (1) develop an SNI framework for precision public health using control systems engineering to improve the delivery of digital educational interventions for health behavior change and (2) validate the SNI framework to increase organ donation awareness in California, taking into account underlying population disparities. Methods: This study developed and tested an SNI framework that uses publicly available data at the ZIP Code Tabulation Area (ZCTA) level to uncover demographic environments using clustering analysis, which is then used to guide digital health interventions using the Meta business platform. The SNI delivered 5 tailored organ donation–related educational contents through Facebook to 4 distinct demographic environments uncovered in California with and without an Adaptive Content Tuning (ACT) mechanism, a novel application of the Proportional Integral Derivative (PID) method, in a cluster randomized trial (CRT) over a 3-month period. The daily number of impressions (ie, exposure to educational content) and clicks (ie, engagement) were measured as a surrogate marker of awareness. A stratified analysis per demographic environment was conducted. Results: Four main clusters with distinctive sociodemographic characteristics were identified for the state of California. The ACT mechanism significantly increased the overall click rate per 1000 impressions (β=.2187; P<.001), with the highest effect on cluster 1 (β=.3683; P<.001) and the lowest effect on cluster 4 (β=.0936; P=.053). Cluster 1 is mainly composed of a population that is more likely to be rural, White, and have a higher rate of Medicare beneficiaries, while cluster 4 is more likely to be urban, Hispanic, and African American, with a high employment rate without high income and a higher proportion of Medicaid beneficiaries. Conclusions: The proposed SNI framework, with its ACT mechanism, learns and delivers, in real time, for each distinct subpopulation, the most tailored educational content and establishes a new standard for precision public health to design novel health interventions with the use of social media, automation, and machine learning in a form that is efficient and equitable. Trial Registration: ClinicalTrials.gov NTC04850287; https://clinicaltrials.gov/ct2/show/NCT04850287 %M 37256680 %R 10.2196/43132 %U https://www.jmir.org/2023/1/e43132 %U https://doi.org/10.2196/43132 %U http://www.ncbi.nlm.nih.gov/pubmed/37256680 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45106 %T Using Principles of an Adaptation Framework to Adapt a Transdiagnostic Psychotherapy for People With HIV to Improve Mental Health and HIV Treatment Engagement: Focus Groups and Formative Research Study %A Darnell,Doyanne %A Ranna-Stewart,Minu %A Psaros,Christina %A Filipowicz,Teresa R %A Grimes,LaKendra %A Henderson,Savannah %A Parman,Mariel %A Gaddis,Kathy %A Gaynes,Bradley Neil %A Mugavero,Michael J %A Dorsey,Shannon %A Pence,Brian W %+ University of Washington, 325 9th Ave, Box 359911, Seattle, WA, 98104, United States, 1 206 744 9108, darnelld@uw.edu %K adaptation %K transdiagnostic psychotherapy %K people with HIV %K trauma %K comorbidity %D 2023 %7 30.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: HIV treatment engagement is critical for people with HIV; however, behavioral health comorbidities and HIV-related stigma are key barriers to engagement. Treatments that address these barriers and can be readily implemented in HIV care settings are needed. Objective: We presented the process for adapting transdiagnostic cognitive behavioral psychotherapy, the Common Elements Treatment Approach (CETA), for people with HIV receiving HIV treatment at a Southern US HIV clinic. Behavioral health targets included posttraumatic stress, depression, anxiety, substance use, and safety concerns (eg, suicidality). The adaptation also included ways to address HIV-related stigma and a component based on Life-Steps, a brief cognitive behavioral intervention to support patient HIV treatment engagement. Methods: We applied principles of the Assessment, Decision, Administration, Production, Topical Experts, Integration, Training, Testing model, a framework for adapting evidence-based HIV interventions, and described our adaptation process, which included adapting the CETA manual based on expert input; conducting 3 focus groups, one with clinic social workers (n=3) and 2 with male (n=3) and female (n=4) patients to obtain stakeholder input for the adapted therapy; revising the manual according to this input; and training 2 counselors on the adapted protocol, including a workshop held over the internet followed by implementing the therapy with 3 clinic patients and receiving case-based consultation for them. For the focus groups, all clinic social workers were invited to participate, and patients were referred by clinic social workers if they were adults receiving services at the clinic and willing to provide written informed consent. Social worker focus group questions elicited reactions to the adapted therapy manual and content. Patient focus group questions elicited experiences with behavioral health conditions and HIV-related stigma and their impacts on HIV treatment engagement. Transcripts were reviewed by 3 team members to catalog participant commentary according to themes relevant to adapting CETA for people with HIV. Coauthors independently identified themes and met to discuss and reach a consensus on them. Results: We successfully used principles of the Assessment, Decision, Administration, Production, Topical Experts, Integration, Training, Testing framework to adapt CETA for people with HIV. The focus group with social workers indicated that the adapted therapy made conceptual sense and addressed common behavioral health concerns and practical and cognitive behavioral barriers to HIV treatment engagement. Key considerations for CETA for people with HIV obtained from social worker and patient focus groups were related to stigma, socioeconomic stress, and instability experienced by the clinic population and some patients’ substance use, which can thwart the stability needed to engage in care. Conclusions: The resulting brief, manualized therapy is designed to help patients build skills that promote HIV treatment engagement and reduce symptoms of common behavioral health conditions that are known to thwart HIV treatment engagement. %M 37252786 %R 10.2196/45106 %U https://formative.jmir.org/2023/1/e45106 %U https://doi.org/10.2196/45106 %U http://www.ncbi.nlm.nih.gov/pubmed/37252786 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43603 %T Black Smokers’ Preferences for Features of a Smoking Cessation App: Qualitative Study %A Enyioha,Chineme %A Loufman,Larissa M %A Grewe,Mary E %A Cené,Crystal W %A Khairat,Saif %A Goldstein,Adam O %A Kistler,Christine E %+ Department of Family Medicine, University of North Carolina at Chapel Hill, 590 Manning Drive, Chapel Hill, NC, 27599, United States, 1 9842155048, chineme_enyioha@med.unc.edu %K mobile health apps %K smoking cessation %K Black smokers %K smoking %K mobile health %K intervention %K application %K development %K online research %K interview %K functionality %K social network %D 2023 %7 30.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Mobile health (mHealth) interventions for smoking cessation have grown extensively over the last few years. Although these interventions improve cessation rates, studies of these interventions consistently lack sufficient Black smokers; hence knowledge of features that make mHealth interventions attractive to Black smokers is limited. Identifying features of mHealth interventions for smoking cessation preferred by Black smokers is critical to developing an intervention that they are likely to use. This may in turn address smoking cessation challenges and barriers to care, which may reduce smoking-related disparities that currently exist. Objective: This study aims to identify features of mHealth interventions that appeal to Black smokers using an evidence-based app developed by the National Cancer Institute, QuitGuide, as a reference. Methods: We recruited Black adult smokers from national web-based research panels with a focus on the Southeastern United States. Participants were asked to download and use QuitGuide for at least a week before participation in remote individual interviews. Participants gave their opinions about features of the QuitGuide app and other mHealth apps they may have used in the past and suggestions for future apps. Results: Of the 18 participants, 78% (n=14) were women, with age ranging from 32 to 65 years. Themes within five major areas relevant for developing a future mHealth smoking cessation app emerged from the individual interviews: (1) content needs including health and financial benefits of quitting, testimonials from individuals who were successful in quitting, and strategies for quitting; (2) format needs such as images, ability to interact with and respond to elements within the app, and links to other helpful resources; (3) functionality including tracking of smoking behavior and symptoms, provision of tailored feedback and reminders to users, and an app that allows for personalization of functions; (4) social network, such as connecting with friends and family through the app, connecting with other users on social media, and connecting with a smoking cessation coach or therapist; and (5) the need for inclusivity for Black individuals, which may be accomplished through the inclusion of smoking-related information and health statistics specific for Black individuals, the inclusion of testimonials from Black celebrities who successfully quit, and the inclusion of cultural relevance in messages contained in the app. Conclusions: Certain features of mHealth interventions for smoking cessation were highly preferred by Black smokers based on their use of a preexisting mHealth app, QuitGuide. Some of these preferences are similar to those already identified by the general population, whereas preferences for increasing the inclusivity of the app are more specific to Black smokers. These findings can serve as the groundwork for a large-scale experiment to evaluate preferences with a larger sample size and can be applied in developing mHealth apps that Black smokers may be more likely to use. %M 37252777 %R 10.2196/43603 %U https://formative.jmir.org/2023/1/e43603 %U https://doi.org/10.2196/43603 %U http://www.ncbi.nlm.nih.gov/pubmed/37252777 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43385 %T A Fully Automated Self-help Biopsychosocial Transdiagnostic Digital Intervention to Reduce Anxiety and/or Depression and Improve Emotional Regulation and Well-being: Pre–Follow-up Single-Arm Feasibility Trial %A Klein,Britt %A Nguyen,Huy %A McLaren,Suzanne %A Andrews,Brooke %A Shandley,Kerrie %+ Health Innovation & Transformation Centre, Federation University Australia, PO Box 663, Ballarat, 3353, Australia, 61 353276717, b.klein@federation.edu.au %K anxiety %K depression %K fully automated %K self-help %K digital intervention %K transdiagnostic %K biopsychosocial %K emotion regulation %K allostatic load %K brain plasticity %K positive affect %K comorbidity %D 2023 %7 30.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Anxiety disorders and depression are prevalent disorders with high comorbidity, leading to greater chronicity and severity of symptoms. Given the accessibility to treatment issues, more evaluation is needed to assess the potential benefits of fully automated self-help transdiagnostic digital interventions. Innovating beyond the current transdiagnostic one-size-fits-all shared mechanistic approach may also lead to further improvements. Objective: The primary objective of this study was to explore the preliminary effectiveness and acceptability of a new fully automated self-help biopsychosocial transdiagnostic digital intervention (Life Flex) aimed at treating anxiety and/or depression, as well as improving emotional regulation; emotional, social, and psychological well-being; optimism; and health-related quality of life. Methods: This was a real-world pre-during-post-follow-up feasibility trial design evaluation of Life Flex. Participants were assessed at the preintervention time point (week 0), during intervention (weeks 3 and 5), at the postintervention time point (week 8), and at 1- and 3-month follow-ups (weeks 12 and 20, respectively). Results: The results provided early support for the Life Flex program in reducing anxiety (Generalized Anxiety Disorder 7), depression (Patient Health Questionnaire 9), psychological distress (Kessler 6), and emotional dysregulation (Difficulties in Emotional Regulation 36) and increasing emotional, social, and psychological well-being (Mental Health Continuum—Short Form); optimism (Revised Life Orientation Test); and health-related quality of life (EQ-5D-3L Utility Index and Health Rating; all false discovery rate [FDR]<.001). Large within-group treatment effect sizes (range |d|=0.82 to 1.33) were found for most variables from pre- to postintervention assessments and at the 1- and 3-month follow-up. The exceptions were medium treatment effect sizes for EQ-5D-3L Utility Index (range Cohen d=−0.50 to −0.63) and optimism (range Cohen d=−0.72 to −0.79) and small-to-medium treatment effect size change for EQ-5D-3L Health Rating (range Cohen d=−0.34 to −0.58). Changes across all outcome variables were generally strongest for participants with preintervention clinical comorbid anxiety and depression presentations (range |d|=0.58 to 2.01) and weakest for participants presenting with nonclinical anxiety and/or depressive symptoms (|d|=0.05 to 0.84). Life Flex was rated as acceptable at the postintervention time point, and participants indicated that they enjoyed the transdiagnostic program and biological, wellness, and lifestyle-focused content and strategies. Conclusions: Given the paucity of evidence on fully automated self-help transdiagnostic digital interventions for anxiety and/or depressive symptomatology and general treatment accessibility issues, this study provides preliminary support for biopsychosocial transdiagnostic interventions, such as Life Flex, as a promising future mental health service delivery gap filler. Following large-scale, randomized controlled trials, the potential benefits of fully automated self-help digital health programs, such as Life Flex, could be considerable. Trial Registration: Australian and New Zealand Clinical Trials Registry ACTRN12615000480583; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368007 %M 37252790 %R 10.2196/43385 %U https://formative.jmir.org/2023/1/e43385 %U https://doi.org/10.2196/43385 %U http://www.ncbi.nlm.nih.gov/pubmed/37252790 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 6 %N %P e47152 %T The Experiences of Informal Caregivers of People With Dementia in Web-Based Psychoeducation Programs: Systematic Review and Metasynthesis %A Yu,Ying %A Xiao,Lily %A Ullah,Shahid %A Meyer,Claudia %A Wang,Jing %A Pot,Anne Margriet %A Shifaza,Fathimath %+ College of Nursing and Health Sciences, Flinders University, Sturt Rd, Bedford Park, South Australia, 5042, Australia, 61 8 82013419, lily.xiao@flinders.edu.au %K informal caregivers %K dementia %K psychoeducation %K online %K web based %K qualitative research %K systematic review %K metasynthesis %D 2023 %7 29.5.2023 %9 Review %J JMIR Aging %G English %X Background: Informal caregivers of people living with dementia experience a higher level of physical and mental stress compared with other types of caregivers. Psychoeducation programs are viewed as beneficial for building caregivers’ knowledge and skills and for decreasing caregiver stress. Objective: This review aimed to synthesize the experiences and perceptions of informal caregivers of people with dementia when participating in web-based psychoeducation programs and the factors that enable and impede informal caregivers’ engagement in web-based psychoeducation programs. Methods: This review followed the Joanna Briggs Institute protocol of systematic review and meta-aggregation of qualitative studies. We searched 4 English databases, 4 Chinese databases, and 1 Arabic database in July 2021. Results: A total of 9 studies written in English were included in this review. From these studies, 87 findings were extracted and grouped into 20 categories. These categories were further synthesized into 5 findings: web-based learning as an empowering experience, peer support, satisfactory and unsatisfactory program content, satisfactory and unsatisfactory technical design, and challenges encountered in web-based learning. Conclusions: High-quality and carefully designed web-based psychoeducation programs offered positive experiences for informal caregivers of people living with dementia. To meet broader caregiver education and support needs, program developers should consider information quality and relevancy, the support offered, individual needs, flexibility in delivery, and connectedness between peers and program facilitators. %M 37247218 %R 10.2196/47152 %U https://aging.jmir.org/2023/1/e47152 %U https://doi.org/10.2196/47152 %U http://www.ncbi.nlm.nih.gov/pubmed/37247218 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 12 %N %P e42001 %T Triggering Weight Management Using Digital Avatars: Prospective Cohort Study %A Jiwa,Moyez %A Nyanhanda,Tafadzwa %A Dodson,Michael %+ School of Medicine, Melbourne Clinical School, The University of Notre Dame Australia, 300 Princes Highway, Werribee, 3030, Australia, 61 282044259, moyez.jiwa@nd.edu.au %K weight management %K digital avatar, behavior change, calorie awareness, obesity, health promotion, motivation, processes of change %K stages of change %K BMI %K weight %K body dysmorphia %K diet %K exercise %K calorie %K tool %K weight management %K digital %D 2023 %7 29.5.2023 %9 Original Paper %J Interact J Med Res %G English %X Background: There is evidence that showing motivated people with a less-than-ideal BMI (>25 kg/m2) digital and personalized images of their future selves with reduced body weight will likely trigger them to achieve that new body weight. Objective: The purpose of this study is to assess whether digital avatars can trigger weight management action and identify some of the measurable factors that distinguish those who may be triggered. Methods: A prospective cohort study followed participants for 12 weeks through 5 recorded interviews. Participants were screened for suitability for the study using the Cosmetic Procedure Screening Questionnaire as a measure of body dysmorphia. At interview 1, participants were shown 10 images from a “Food-pics” database and invited to estimate their calorie value. The intervention, the FutureMe app, delivered at interview 2, provided each participant an opportunity to see and take away a soft copy of an avatar of themselves as they might appear in the future depending on their calorie consumption and exercise regimen. Participants completed the readiness for change (S-Weight) survey based on Prochaska Stages of Change Model and the processes of change (P-Weight) survey. Any changes in diet, exercise, or weight were self-reported. Results: A total of 87 participants were recruited, and 42 participants completed the study (48% of recruited participants). Body dysmorphia was a rare but possible risk to participation. The majority (88.5%) of the participants were female and older than 40 years. The average BMI was 34.1 (SD 4.8). Most people wanted to reduce to a BMI of 30 kg/m2 or lose on average 10.5 kg within 13 weeks (–0.8 kg per week). Most participants stated that they would achieve these results by limiting their calorie intake to 1500 calories per day and taking the equivalent of 1 hour of bicycling per day. At interview 1, more participants were in the preparation stage of behavior change than in subsequent interviews. By interview 5, most of the participants were at the maintenance stage. Participants who overestimated the recommended number of calories were more likely to be in the contemplation stage (P=.03). Conclusions: Volunteers who participated in the study were mainly women older than 40 years and beyond the contemplation stage of change for weight management, and those who took weight management action were demonstrated to have a more accurate idea of the calorie content of different foods. Most participants set ambitious targets for weight loss, but few, if any, achieve these goals. However, most people who completed this study were actively taking action to manage their weight. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619001481167; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378055&isReview=true %M 37247208 %R 10.2196/42001 %U https://www.i-jmr.org/2023/1/e42001 %U https://doi.org/10.2196/42001 %U http://www.ncbi.nlm.nih.gov/pubmed/37247208 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45894 %T Preliminary Evaluation of a Conversational Agent to Support Self-management of Individuals Living With Posttraumatic Stress Disorder: Interview Study With Clinical Experts %A Han,Hee Jeong %A Mendu,Sanjana %A Jaworski,Beth K %A Owen,Jason E %A Abdullah,Saeed %+ College of Information Sciences and Technology, Pennsylvania State University, Westgate Building, University Park, PA, 16802, United States, 1 (814) 865 8947, heejeonghan@psu.edu %K conversational agent %K PTSD %K self-management %K clinical experts %K evaluation %K support system %K mental health %K trauma %D 2023 %7 29.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Posttraumatic stress disorder (PTSD) is a serious public health concern. However, individuals with PTSD often do not have access to adequate treatment. A conversational agent (CA) can help to bridge the treatment gap by providing interactive and timely interventions at scale. Toward this goal, we have developed PTSDialogue—a CA to support the self-management of individuals living with PTSD. PTSDialogue is designed to be highly interactive (eg, brief questions, ability to specify preferences, and quick turn-taking) and supports social presence to promote user engagement and sustain adherence. It includes a range of support features, including psychoeducation, assessment tools, and several symptom management tools. Objective: This paper focuses on the preliminary evaluation of PTSDialogue from clinical experts. Given that PTSDialogue focuses on a vulnerable population, it is critical to establish its usability and acceptance with clinical experts before deployment. Expert feedback is also important to ensure user safety and effective risk management in CAs aiming to support individuals living with PTSD. Methods: We conducted remote, one-on-one, semistructured interviews with clinical experts (N=10) to gather insight into the use of CAs. All participants have completed their doctoral degrees and have prior experience in PTSD care. The web-based PTSDialogue prototype was then shared with the participant so that they could interact with different functionalities and features. We encouraged them to “think aloud” as they interacted with the prototype. Participants also shared their screens throughout the interaction session. A semistructured interview script was also used to gather insights and feedback from the participants. The sample size is consistent with that of prior works. We analyzed interview data using a qualitative interpretivist approach resulting in a bottom-up thematic analysis. Results: Our data establish the feasibility and acceptance of PTSDialogue, a supportive tool for individuals with PTSD. Most participants agreed that PTSDialogue could be useful for supporting self-management of individuals with PTSD. We have also assessed how features, functionalities, and interactions in PTSDialogue can support different self-management needs and strategies for this population. These data were then used to identify design requirements and guidelines for a CA aiming to support individuals with PTSD. Experts specifically noted the importance of empathetic and tailored CA interactions for effective PTSD self-management. They also suggested steps to ensure safe and engaging interactions with PTSDialogue. Conclusions: Based on interviews with experts, we have provided design recommendations for future CAs aiming to support vulnerable populations. The study suggests that well-designed CAs have the potential to reshape effective intervention delivery and help address the treatment gap in mental health. %M 37247220 %R 10.2196/45894 %U https://formative.jmir.org/2023/1/e45894 %U https://doi.org/10.2196/45894 %U http://www.ncbi.nlm.nih.gov/pubmed/37247220 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44979 %T A Financial Incentives Program to Promote Smoking Cessation Among Recently Hospitalized Individuals: Feasibility and Acceptability Study %A Shusterman,Sara %A Villarreal-Calderon,Rodolfo %A Gunawan,Adrian %A Gallardo Foreman,Alexis %A O'Donnell,Charles %A Wakeman,Cornelia %A Javeed,Hadi %A Keteyian,Jacob %A Howard,Jinesa %A Bulekova,Katia %A de Silva,Shalen %A Campbell,Trevor %A Lasser,Karen %A Kathuria,Hasmeena %+ Boston University Chobanian & Avedisian School of Medicine, 725 Albany Street, Boston, MA, 02118, United States, 1 6176583564, sara.shusterman@bmc.org %K financial incentives %K mobile application %K smoking cessation %K tobacco treatment intervention %D 2023 %7 29.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Hospitalization is an opportunity to engage underserved individuals in tobacco treatment who may not otherwise have access to it. Tobacco treatment interventions that begin during hospitalization and continue for at least 1 postdischarge month are effective in promoting smoking cessation. However, there is low usage of postdischarge tobacco treatment services. Financial incentives for smoking cessation are an intervention in which participants receive incentives, such as cash payments or vouchers for goods, to encourage individuals to stop smoking or to reward individuals for maintaining abstinence. Objective: We sought to determine the feasibility and acceptability of a novel postdischarge financial incentive intervention that uses a smartphone application paired to measurements of exhaled carbon monoxide (CO) concentration levels to promote smoking cessation in individuals who smoke cigarettes. Methods: We collaborated with Vincere Health, Inc. to tailor their mobile application that uses facial recognition features, a portable breath test CO monitor, and smartphone technology to deliver financial incentives to a participant’s digital wallet after the completion of each CO test. The program includes 3 racks. Track 1: Noncontingent incentives for conducting CO tests. Track 2: Combination of noncontingent and contingent incentives for CO levels <10 parts per million (ppm). Track 3: Contingent incentives only for CO levels <10 ppm. After obtaining informed consent, we pilot-tested the program from September to November 2020 with a convenience sample of 33 hospitalized individuals at Boston Medical Center, a large safety-net hospital in New England. Participants received text reminders to conduct CO tests twice daily for 30 days postdischarge. We collected data on engagement, CO levels, and incentives earned. We measured feasibility and acceptability quantitatively and qualitatively at 2 and 4 weeks. Results: Seventy-six percent (25/33) completed the program and 61% (20/33) conducted at least 1 breath test each week. Seven patients had consecutive CO levels <10 ppm during the last 7 days of the program. Engagement with the financial incentive intervention as well as in-treatment abstinence was highest in Track 3 that delivered financial incentives contingent on CO levels <10 ppm. Participants reported high program satisfaction and that the intervention helped motivate smoking cessation. Participants suggested increasing program duration to at least 3 months and adding supplemental text messaging to increase motivation to stop smoking. Conclusions: Financial incentives paired to measurements of exhaled CO concentration levels is a novel smartphone-based tobacco cessation approach that is feasible and acceptable. Future studies should examine the efficacy of the intervention after it is refined to add a counseling or text-messaging component. %M 37247216 %R 10.2196/44979 %U https://formative.jmir.org/2023/1/e44979 %U https://doi.org/10.2196/44979 %U http://www.ncbi.nlm.nih.gov/pubmed/37247216 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42238 %T Conversational Agents for Body Weight Management: Systematic Review %A Noh,Eunyoung %A Won,Jiyoon %A Jo,Sua %A Hahm,Dae-Hyun %A Lee,Hyangsook %+ Department of Medical Science of Meridian, College of Korean Medicine, Kyung Hee University, 26 Kyung Hee Dae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea, 82 2 961 0703, erc633@khu.ac.kr %K conversational agent %K chatbot %K obesity %K weight management %K artificial intelligence %K behavioral therapy %D 2023 %7 26.5.2023 %9 Review %J J Med Internet Res %G English %X Background: Obesity is a public health issue worldwide. Conversational agents (CAs), also frequently called chatbots, are computer programs that simulate dialogue between people. Owing to better accessibility, cost-effectiveness, personalization, and compassionate patient-centered treatments, CAs are expected to have the potential to provide sustainable lifestyle counseling for weight management. Objective: This systematic review aimed to critically summarize and evaluate clinical studies on the effectiveness and feasibility of CAs with unconstrained natural language input for weight management. Methods: PubMed, Embase, the Cochrane Library (CENTRAL), PsycINFO, and ACM Digital Library were searched up to December 2022. Studies were included if CAs were used for weight management and had a capability for unconstrained natural language input. No restrictions were imposed on study design, language, or publication type. The quality of the included studies was assessed using the Cochrane risk-of-bias assessment tool or the Critical Appraisal Skills Programme checklist. The extracted data from the included studies were tabulated and narratively summarized as substantial heterogeneity was expected. Results: In total, 8 studies met the eligibility criteria: 3 (38%) randomized controlled trials and 5 (62%) uncontrolled before-and-after studies. The CAs in the included studies were aimed at behavior changes through education, advice on food choices, or counseling via psychological approaches. Of the included studies, only 38% (3/8) reported a substantial weight loss outcome (1.3-2.4 kg decrease at 12-15 weeks of CA use). The overall quality of the included studies was judged as low. Conclusions: The findings of this systematic review suggest that CAs with unconstrained natural language input can be used as a feasible interpersonal weight management intervention by promoting engagement in psychiatric intervention-based conversations simulating treatments by health care professionals, but currently there is a paucity of evidence. Well-designed rigorous randomized controlled trials with larger sample sizes, longer treatment duration, and follow-up focusing on CAs’ acceptability, efficacy, and safety are warranted. %M 37234029 %R 10.2196/42238 %U https://www.jmir.org/2023/1/e42238 %U https://doi.org/10.2196/42238 %U http://www.ncbi.nlm.nih.gov/pubmed/37234029 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 9 %N %P e45037 %T Effects of Active Video Games in Patients With Cancer: Systematic Review %A Peyrachon,Romane %A Rébillard,Amélie %+ Movement, Sport and Heath Sciences laboratory M2S-EA7470, University of Rennes 2, 14 Av. Robert Schuman, Campus de Ker Lann, Rennes, 35170, France, 33 609379245, romane.peyrachon@ens-rennes.fr %K exergaming %K cancer %K physical activity %K fatigue %K endurance %K strength %K adjuvant therapy %K cancer therapy %K cancer treatment %K video games %K digital health intervention %K cancer patient %D 2023 %7 26.5.2023 %9 Review %J JMIR Cancer %G English %X Background: Physical activity (PA) is now considered an adjuvant therapy in cancer treatment; nevertheless, multiple barriers could reduce PA engagement during treatment. Active video games (AVGs) lead to the achievement of mild- to moderate-intensity PA and represent a promising tool for regular movement and exercise. Objective: This paper aims to review the current literature and provide updated content on the physiological and psychological effects of AVG-based interventions in patients with cancer undergoing treatment. Methods: Four electronic databases were investigated. Studies reporting on AVG interventions delivered to patients undergoing treatment were included. A total of 21 articles (17 interventions) were identified for data extraction and quality assessment. Results: A total of 362 patients with cancer participated in the studies (number of participants 3-70). The majority underwent treatment for breast, lung, prostate, hematologic, or oral or laryngeal cancer. The types and stages of cancer varied in all studies. Participants ranged in age from 3 to 93 years. Four studies included patients with pediatric cancer. The duration of interventions ranged from 2 to 16 weeks, with a minimum of 2 sessions per week and a maximum of 1 daily session. Sessions were supervised in 10 studies, and 7 included home-based interventions. AVG interventions improved endurance, quality of life, cancer-related fatigue, and self-efficacy. Effects were mixed on strength, physical function, and depression. AVGs did not affect activity level, body composition, or anxiety. Compared with standard physiotherapy, physiological effects were lower or similar, and psychological effects were higher or similar. Conclusions: Overall, our results suggest that AVGs can be recommended to patients undergoing cancer treatment, given the physiological and psychological benefits. When AVGs are proposed, supervision of the sessions should be considered as it can limit dropouts. In the future, it is important to develop AVGs that combine endurance and muscle strengthening, with the possibility of achieving moderate to high exercise intensity, depending on the physical abilities of the patients, as indicated in the World Health Organization’s recommendations. %M 37234028 %R 10.2196/45037 %U https://cancer.jmir.org/2023/1/e45037 %U https://doi.org/10.2196/45037 %U http://www.ncbi.nlm.nih.gov/pubmed/37234028 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e41643 %T Internet-Based Behavioral Activation for Depression: Systematic Review and Meta-Analysis %A Alber,Carolin Sophie %A Krämer,Lena Violetta %A Rosar,Sophia Marie %A Mueller-Weinitschke,Claudia %+ Department of Rehabilitation Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Engelbergerstraße 41, Freiburg, 79085, Germany, 49 (0)761 203 9439, claudia.mueller-weinitschke@psychologie.uni-freiburg.de %K behavioral activation %K depression %K systematic review %K meta-analysis %K internet- and mobile-based intervention %D 2023 %7 25.5.2023 %9 Review %J J Med Internet Res %G English %X Background: Behavioral activation is an effective treatment for reducing depression. As depressive disorders affect many people worldwide, internet-based behavioral activation (iBA) could provide enhanced treatment access. Objective: This study aimed to investigate whether iBA is effective in reducing depressive symptoms and to assess the impact on secondary outcomes. Methods: We systematically searched MEDLINE, PsycINFO, PSYNDEX, and CENTRAL up to December 2021 for eligible randomized controlled trials. In addition, a reference search was conducted. Title and abstract screening, as well as a full-text screening, was conducted by 2 independent reviewers. Randomized controlled trials that investigated the effectiveness of iBA for depression as a treatment or main component were included. Randomized controlled trials had to report depressive symptoms, with a quantitative outcome measure and assess an adult population with depressive symptoms above cutoff. Two independent reviewers performed the data extraction and risk of bias assessment. Data were pooled in random-effects meta-analyses. The primary outcome was self-reported depressive symptoms posttreatment. This systematic review and meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines. Results: A total of 12 randomized controlled trials, with 3274 participants (88% female, 43.61 years) were included. iBA was more effective in reducing depressive symptom severity posttreatment than inactive control groups (standardized mean difference −0.49; 95% CI −0.63 to −0.34; P<.001). The overall level of heterogeneity was moderate to substantial (I2=53%). No significant effect of iBA on depressive symptoms could be found at 6-month follow-up. Participants assigned to iBA also experienced a significant reduction of anxiety and a significant increase in quality of life and activation compared to the inactive control groups. The results remained robust in multiple sensitivity analyses. The risk of bias assessment revealed at least some concerns for all studies, and there was evidence of slight publication bias. Conclusions: This systematic review and meta-analysis implies that iBA is effective in reducing depressive symptoms. It represents a promising treatment option, providing treatment access where no treatment is available yet. Trial Registration: International Prospective Register of Systematic Reviews CRD42021236822; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=236822 %M 37227760 %R 10.2196/41643 %U https://www.jmir.org/2023/1/e41643 %U https://doi.org/10.2196/41643 %U http://www.ncbi.nlm.nih.gov/pubmed/37227760 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45276 %T Web-Based Knowledge Translation Tool About Pediatric Acute Gastroenteritis for Parents: Pilot Randomized Controlled Trial %A Hartling,Lisa %A Elliott,Sarah A %A Munan,Matthew %A Scott,Shannon D %+ Department of Pediatrics, University of Alberta, Edmonton Clinic Health Academy 4-472, 11405-87 Avenue NW, Edmonton, AB, T6G 1C9, Canada, 1 780 492 6124, hartling@ualberta.ca %K knowledge translation %K pediatric acute gastroenteritis %K emergency department %K health care decision-making %K multiple methods %K randomized controlled trial %K qualitative interviews %K web-based tool %D 2023 %7 25.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Acute gastroenteritis (AGE) in children is a leading cause of emergency department (ED) visits, resulting in substantial health care costs and stress for families and caregivers. The majority of pediatric AGE cases are caused by viral infections and can be managed at home using strategies to prevent dehydration. To increase knowledge of, and support health decision-making for, pediatric AGE, we developed a knowledge translation (KT) tool (fully automated web-based whiteboard animation video). Objective: The aim of this study was to assess the potential effectiveness of the web-based KT tool in terms of knowledge, health care decision-making, use of resources, and perceived benefit and value. Methods: A convenience sample of parents was recruited between December 18, 2020, and August 10, 2021. Parents were recruited in the ED of a pediatric tertiary care hospital and followed for up to 14 days after the ED visit. The eligibility criteria included parent or legal guardian of a child aged <16 years presenting to the ED with an acute episode of diarrhea or vomiting, ability to communicate in English, and agreeable to follow-up via email. Parents were randomized to receive the web-based KT tool (intervention) about AGE or a sham video (control) during their ED visit. The primary outcome was knowledge assessed before the intervention (baseline), immediately after the intervention, and at follow-up 4 to 14 days after ED discharge. Other outcomes included decision regret, health care use, and KT tool usability and satisfaction. The intervention group participants were invited to participate in a semistructured interview to gather additional feedback about the KT tool. Results: A total of 103 parents (intervention: n=51, 49.5%, and control: n=52, 50.5%) completed the baseline and postintervention assessments. Of these 103 parents, 78 (75.7%; intervention: n=36, 46%, and control: n=42, 54%) completed the follow-up questionnaire. Knowledge scores after the intervention (mean 8.5, SD 2.6 vs mean 6.3, SD 1.7; P<.001) and at follow-up (mean 9.1, SD 2.7 vs mean 6.8, SD 1.6; P<.001) were significantly higher in the intervention group. After the intervention, parents in the intervention group reported greater confidence in knowledge than those in the control group. No significant difference in decision regret was found at any time point. Parents rated the KT tool higher than the sham video across 5 items assessing usability and satisfaction. Conclusions: The web-based KT tool improved parental knowledge about AGE and confidence in their knowledge, which are important precursors to behavior change. Further research is needed into understanding what information and delivery format as well as other factors influence parents’ decision-making regarding their child’s health. Trial Registration: ClinicalTrials.gov NCT03234777; https://clinicaltrials.gov/ct2/show/NCT03234777 International Registered Report Identifier (IRRID): RR2-10.1186/s40814-018-0318-0 %M 37227758 %R 10.2196/45276 %U https://formative.jmir.org/2023/1/e45276 %U https://doi.org/10.2196/45276 %U http://www.ncbi.nlm.nih.gov/pubmed/37227758 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e41944 %T Effects of WAKE.TAIWAN Healthy Lifestyle Web-Based Promotion Programs on Adults’ Awareness of Self-perceived Weight Status and Their Healthy Lifestyle Stages: Retrospective Analysis %A Lord,Asta Y Z %A Pan,Wen-Harn %+ Institute of Population Health Sciences, National Health Research Institutes, 35, Keyan Road, Zhunan Town, Miaoli County, 350, Taiwan, 886 37 206166 ext 36309, 850501@nhri.edu.tw %K healthy eating %K active living %K obese %K weight %K social media %K website %K web based %K health behavior %K online health promotion %K obesity %K chronic disease %K healthy lifestyle %K lifestyle %K health promotion %K health education %K online health information %K quasi-experimental %K questionnaire %K survey research %K applied method %K nutrition %K food %K eat %K confidence interval %K generalized linear model %D 2023 %7 25.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Obesity is a major risk factor of many chronic diseases. However, current obesity control policies and actions are not sufficient to halt the pandemic. It has been documented that more than half of all adults are not able to interpret their own weight status, not to mention to practice healthy lifestyles. Social media and interactive websites can reach people on a long-term basis, which may be used as intervention vehicles to build up cognition for weight control and to promote healthy behavior practices. Objective: WAKE.TAIWAN is an ongoing web-based multifaceted healthy lifestyle promotion program with social media and interactive websites as the intervention vehicle. This study aimed to examine whether adults reached by our program would have increased awareness to their own anthropometric measures, correctly judge their body weight status, and practice healthy behaviors over time. Methods: This study adopted a quasi-experimental design with web-based questionnaire surveys. The experimental group consisted of WAKE.TAIWAN Facebook group members aged 20-65 years who have used the interactive website health education resources (n=177). The group was further stratified into 2 subgroups based on their duration of participation (E1 group: duration <1 year; E2 group: duration ≥1 year). The control group consisted of other Facebook users (n=545) in the same age range who had not been exposed to the health education materials of this project. A total of 722 people (male: n=267, 37%; and female: n=455, 63%) participated in our survey in 2019. Data were analyzed to evaluate program effectiveness using a generalized linear model. Results: The proportion of people correctly interpreting their own weight status in the experimental group was greater than that of the control group (control group: 320/545, 58.7%; group E1: 53/88, 60%; and group E2: 64/89, 72%). The E2 experimental group was significantly better than the control group in paying attention to weight-related measures and in correctly interpreting their own weight status (odds ratio 1.73, 95% CI 1.04-2.89; P=.04). With respect to the behavioral stages of practicing healthy eating and active living, both experimental groups, E1 and E2, performed significantly better than the control group (group E1: P=.003 and P=.02; and group E2: P=.004 and P<.001, respectively). Conclusions: This study demonstrates that the longer the participants were exposed to our social media–based programs, the higher the proportion of them that would have the correct judgement on their weight status and fall in the higher stages of healthy lifestyle behaviors. A longitudinal follow-up survey is in place to verify these findings. %M 37227770 %R 10.2196/41944 %U https://formative.jmir.org/2023/1/e41944 %U https://doi.org/10.2196/41944 %U http://www.ncbi.nlm.nih.gov/pubmed/37227770 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e41283 %T Efficacy and Cost-Effectiveness Analysis of Internet-Based Cognitive Behavioral Therapy for Obsessive-Compulsive Disorder: Randomized Controlled Trial %A Wu,Yiwen %A Li,Xin %A Zhou,Yuxin %A Gao,Rui %A Wang,Kaifeng %A Ye,Huiling %A Lyu,Na %A Wang,Chun %A Zhang,Ning %A Wang,Zhen %A Fan,Qing %+ Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 Wan Ping Nan Road, Shanghai, 200030, China, 86 18017311322, fanqing@smhc.org.cn %K obsessive-compulsive disorder %K cognitive behavioral therapy %K internet-based cognitive behavioral therapy %K cost-effectiveness %K randomized controlled trial %D 2023 %7 24.5.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Obsessive-compulsive disorder (OCD) is a common and chronic mental illness with a high rate of disability. Internet-based cognitive behavioral therapy (ICBT) makes online treatment available to patients and has been shown to be effective. However, 3-arm trials on ICBT, face-to-face cognitive behavioral group therapy (CBGT), and only medication are still lacking. Objective: This study is a randomized, controlled, assessor-blinded trial of 3 groups for OCD: ICBT combined with medication, CBGT combined with medication, and conventional medical treatment (ie, treatment as usual [TAU]). The study aims to investigate the efficacy and cost-effectiveness of ICBT related to CBGT and TAU for adults with OCD in China. Methods: In total, 99 patients with OCD were selected and randomly assigned to the ICBT, CBGT, and TAU groups for treatment for 6 weeks. The primary outcomes were the Yale-Brown Obsessive-Compulsive Scale (YBOCS) and the self-rating Florida Obsessive-Compulsive Inventory (FOCI), compared at baseline, during treatment (3 weeks), and after treatment (6 weeks), to analyze efficacy. The secondary outcome was the EuroQol Visual Analogue Scale (EQ-VAS) scores of the EuroQol 5D Questionnaire (EQ-5D). The cost questionnaires were recorded to analyze cost-effectiveness. Results: Repeated-measures ANOVA was used for data analysis, and the final effective sample size was 93 (ICBT: n=32, 34.4%; CBGT: n=28, 30.1%; TAU: n=33, 35.5%). After 6-week treatment, the YBOCS scores of the 3 groups significantly decreased (P<.001), and there were no significant differences among groups. The FOCI score of the ICBT (P=.001) and CBGT (P=.035) groups was significantly lower than that of the TAU group after treatment. The total cost of the CBGT group (renminbi [RMB] 6678.45, 95% CI 4460.88-8896.01 [US $1010.36, 95% CI 678.87-1345.84]) was significantly higher than that of the ICBT group (RMB 3308.81, 95% CI 2476.89-4140.73[US $500.58, 95% CI 374.72-626.43], P<.001) and the TAU group (RMB 2259.61, 95% CI 2074.16-2445.05 [US $341.85, 95% CI 313.79-369.90], P<.001) after treatment. The ICBT group spent RMB 303.19 (US $45.97) less than the CBGT group and RMB 11.57 (US $1.75) less than the TAU group for each unit reduction in the YBOCS score. Conclusions: Therapist-guided ICBT combined with medication is as effective as face-to-face CBGT combined with medication for OCD. ICBT combined with medication is more cost-effective than CBGT combined with medication and conventional medical treatment. It is expected to become an efficacious and economic alternative for adults with OCD when face-to-face CBGT is not available. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900023840; https://www.chictr.org.cn/showproj.html?proj=39294 %M 37223977 %R 10.2196/41283 %U https://www.jmir.org/2023/1/e41283 %U https://doi.org/10.2196/41283 %U http://www.ncbi.nlm.nih.gov/pubmed/37223977 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e38073 %T Codevelopment of a Text Messaging Intervention to Support Adherence to Adjuvant Endocrine Therapy in Women With Breast Cancer: Mixed Methods Approach %A Green,Sophie M C %A French,David P %A Hall,Louise H %A Bartlett,Yvonne Kiera %A Rousseau,Nikki %A Raine,Erin %A Parbutt,Catherine %A Gardner,Benjamin %A , %A Smith,Samuel G %+ Leeds Institute of Health Sciences, University of Leeds, Clarendon Way, Leeds, LS2 9LU, United Kingdom, 44 1133430892, s.m.c.green@leeds.ac.uk %K breast cancer %K medication adherence %K habit formation %K behavior change techniques %K SMS text messages %K intervention development %D 2023 %7 24.5.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Adjuvant endocrine therapy (AET) reduces breast cancer recurrence and mortality in women with early-stage breast cancer. Unintentional nonadherence to AET is common (eg, forgetting to take medication). Forming habits surrounding medication taking could reduce reliance on memory and improve AET adherence. SMS text messaging interventions may offer a low-cost approach for promoting medication-taking habits. To optimize the likely effectiveness of such SMS text messages, the content should be developed using a transparent approach to ensure fidelity to relevant psychological theory and with user input to increase acceptability. Objective: This study aimed to develop a pool of brief SMS text messages promoting habit formation to support AET adherence, which are acceptable to women with breast cancer and show fidelity to theory-based behavior change techniques (BCTs). Methods: According to published literature, we selected 6 BCTs derived from the habit formation model: action planning, habit formation, restructuring the physical environment, adding objects to the environment, prompts/cues, and self-monitoring of behavior. In study 1, behavior change experts (n=10) created messages, each based on 1 of the 6 BCTs, in a web-based workshop and rated the fidelity of the messages to the intended BCT. In study 2, women with experience of taking AET discussed the acceptability of the messages in a focus group (n=5), and the messages were refined following this. In study 3, women with breast cancer rated the acceptability of each message in a web-based survey (n=60). In study 4, additional behavior change experts rated the fidelity of the remaining messages to the intended BCT in a web-based survey (n=12). Finally, a consultant pharmacist reviewed a selection of messages to ensure that they did not contradict general medical advice. Results: In study 1, 189 messages were created targeting the 6 BCTs. In total, 92 messages were removed because they were repetitious, unsuitable, or >160 characters, and 3 were removed because of low fidelity (scoring <5.5/10 on a fidelity rating scale). Following study 2, we removed 13 messages considered unacceptable to our target population. In study 3, all remaining messages scored above the midpoint on an acceptability scale (1-5); therefore, no messages were removed (mean 3.9/5, SD 0.9). Following study 4, we removed 13 messages owing to low fidelity (scoring <5.5/10 on a fidelity rating scale). All the remaining messages showed fidelity to the intended BCTs (mean 7.9/10, SD 1.3). Following the pharmacist review, 2 messages were removed, and 3 were amended. Conclusions: We developed a pool of 66 brief SMS text messages targeting habit formation BCTs to support AET adherence. These showed acceptability to women with breast cancer and fidelity to the intended BCTs. The delivery of the messages will be further evaluated to assess their effect on medication adherence. %M 37223964 %R 10.2196/38073 %U https://www.jmir.org/2023/1/e38073 %U https://doi.org/10.2196/38073 %U http://www.ncbi.nlm.nih.gov/pubmed/37223964 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43592 %T Designing a Dyad-Based Digital Health Intervention to Reduce Sedentary Time in Black Breast Cancer Survivors and Their First-degree Relatives: Human-Centered Design Study %A Blazey,Meghan %A Marinac,Catherine %A Whiteley,Jessica %A Peterson,Sarah %A Burns White,Karen %A Jacques,Cathyanah %A Lam,Helen %A Halpenny,Barbara %A Patel,Shree %A Lamothe,Raymond %A Wright,Julie %+ School of Nursing, University of Rochester, 601 Elmwood Ave, Box SON, Rochester, NY, 14642, United States, 1 585 276 6123, meghan_blazey@urmc.rochester.edu %K sedentary behavior %K digital health %K dyad-based intervention %K breast cancer risk %K breast cancer survivor %K social support %K mobile phone %D 2023 %7 24.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Breast cancer, the most commonly diagnosed cancer and second leading cause of cancer-related death in women in the United States, disproportionately affects women from minoritized or low socioeconomic backgrounds. The average woman has an approximately 12% lifetime risk of developing breast cancer. Lifetime risk nearly doubles if a woman has a first-degree relative with breast cancer, and the risk increases as multiple family members are affected. Decreasing sedentary behaviors through moving more and sitting less reduces breast cancer risk and improves outcomes for cancer survivors and healthy adults. Digital health solutions, such as mobile apps that are culturally appropriate, designed with input from the target audience, and include social support, are effective at improving health behaviors. Objective: This study aimed to develop and evaluate the usability and acceptability of a prototype app designed with a human-centered approach to promote moving more and sitting less in Black breast cancer survivors and their first-degree relatives (parent, child, or sibling). Methods: This 3-phase study consisted of app development, user testing, and evaluation of user engagement and usability. Key community stakeholders were engaged in the first 2 (qualitative) phases to provide input into developing the prototype app (MoveTogether). After development and user testing, a usability pilot was conducted. Participants were adult breast cancer survivors who identified as Black and agreed to participate with a relative. Participants used the app and a step-tracking watch for 4 weeks. App components included goal setting and reporting, reminders, dyad messaging, and educational resources. Usability and acceptability were assessed with a questionnaire that included the System Usability Scale (SUS) and semistructured interviews. Data were analyzed with descriptive statistics and content analysis. Results: Participants in the usability pilot (n=10) were aged 30 to 50 years (6/10, 60%), not married (8/10, 80%), and college graduates (5/10, 50%). The app was used on average 20.2 (SD 8.9) out of 28 days—SUS score of 72 (range 55-95)—and 70% (7/10) agreed that the app was acceptable, helpful, and gave them new ideas. Additionally, 90% (9/10) found the dyad component helpful and would recommend the app to friends. Qualitative findings suggest that the goal-setting feature was helpful and that the dyad partner (buddy) provided accountability. Participants were neutral regarding the cultural appropriateness of the app. Conclusions: The MoveTogether app and related components were acceptable for promoting moving more in dyads of breast cancer survivors and their first-degree relatives. The human-centered approach, which involved engaging community members in the development, is a model for future technology development work. Future work should be done to further develop the intervention based on the findings and then test its efficacy to improve sedentary behavior while considering culturally informed strategies for adoption and implementation within the community. Trial Registration: ClinicalTrials.gov NCT05011279; https://clinicaltrials.gov/ct2/show/NCT05011279 %M 37223968 %R 10.2196/43592 %U https://formative.jmir.org/2023/1/e43592 %U https://doi.org/10.2196/43592 %U http://www.ncbi.nlm.nih.gov/pubmed/37223968 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e39158 %T Acceptability of Online Yoga Among Individuals With Chronic Conditions and Their Caregivers: Qualitative Study %A Portz,Jennifer Dickman %A Schmid,Arlene %A Fruhauf,Christine %A Fox,Aimee %A Van Puymbroeck,Marieke %A Sharp,Julia %A Leach,Heather %+ University of Colorado, Mailstop B119, 13001 East 17th Place, Aurora, CO, 80045, United States, 1 303 724 8856, jennifer.portz@CUAnschutz.edu %K yoga %K meditative movement %K online %K chronic conditions %K self-management %K caregiver %K dyads %K meditation %K participation %K perspective %K intervention %D 2023 %7 24.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The online delivery of yoga interventions rapidly expanded during the COVID-19 pandemic, and preliminary studies indicate that online yoga is feasible across multiple chronic conditions. However, few yoga studies provide synchronous online yoga sessions and rarely target the caregiving dyad. Online chronic disease management interventions have been evaluated across conditions, life spans, and diverse samples. However, the perceived acceptability of online yoga, including self-reported satisfaction and online delivery preferences, is underexplored among individuals with chronic conditions and their caregivers. Understanding user preferences is essential for successful and safe online yoga implementation. Objective: We aimed to qualitatively examine the perceived acceptability of online yoga among individuals with chronic conditions and their caregivers who participated in an online dyadic intervention that merged yoga and self-management education to develop skills (MY-Skills) to manage persistent pain. Methods: We conducted a qualitative study among 9 dyads (>18 years of age; individuals experiencing persistent moderate pain) who participated in MY-Skills online during the COVID-19 pandemic. The intervention consisted of 16 online, synchronous yoga sessions over 8 weeks for both dyad members. After the completion of the intervention, participants (N=18) participated in semistructured telephone interviews for around 20 minutes, discussing their preferences, challenges, and recommendations for improved online delivery. Interviews were analyzed by using a rapid analytic approach. Results: MY-Skills participants were, on average, aged 62.7 (SD 19) years; were primarily women; were primarily White; and had a mean of 5.5 (SD 3) chronic conditions. Both participants and caregivers reported moderate pain severity scores (mean 6.02, SD 1.3) on the Brief Pain Inventory. The following three themes were identified related to online delivery: (1) participants indicated a preference for the intervention to be in person rather than online because they were distracted in the home setting, because they felt that in-person yoga would be more engaging, because the yoga therapist could physically correct positions, and because of safety concerns (eg, fear of falling); (2) participants indicated good acceptability of online MY-Skills delivery due to convenience, access, and comfort with being in their home; and (3) recommendations for improving online delivery highlighted a need for additional and accessible technical support. Conclusions: Both individuals with chronic conditions and their caregivers find online yoga to be an acceptable intervention. Participants who preferred in-person yoga did so due to distractions in the home and group dynamics. Some participants preferred in-person corrections to ensure correct positioning, while others felt safe with verbal modifications in their homes. Convenience and access were the primary reasons for preferring online delivery. To improve online delivery, future yoga studies should include specific activities for fostering group engagement, enhancing safety protocols, and increasing technical support. Trial Registration: ClinicalTrials.gov NCT03440320; https://clinicaltrials.gov/ct2/show/NCT03440320 %M 37223971 %R 10.2196/39158 %U https://formative.jmir.org/2023/1/e39158 %U https://doi.org/10.2196/39158 %U http://www.ncbi.nlm.nih.gov/pubmed/37223971 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47195 %T Coping After Breast Cancer: Protocol for a Randomized Controlled Trial of Stress Management eHealth Interventions %A Svendsen,Karianne %A Nes,Lise Solberg %A Meland,Anders %A Larsson,Ine Marie %A Gjelsvik,Ylva M %A Børøsund,Elin %A Rygg,Christine M %A Myklebust,Tor Åge %A Reinertsen,Kristin V %A Kiserud,Cecilie E %A Skjerven,Helle %A Antoni,Michael H %A Chalder,Trudie %A Mjaaland,Ingvil %A Carlson,Linda E %A Eriksen,Hege R %A Ursin,Giske %+ Cancer Registry of Norway, Oslo University Hospital, Ullernchausséen 64, Oslo, 0379, Norway, 47 99011452, gu@kreftregisteret.no %K breast cancer %K stress management %K mindfulness %K cognitive behavioral therapy %K psychosocial %K StressProffen %K RCT %K eHealth %K digital %K intervention %D 2023 %7 24.5.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: One-third or more of breast cancer survivors report stress and other psychological and physical complaints that can negatively impact their quality of life. Psychosocial stress management interventions, shown to mitigate the negative impact of these complaints, can now be delivered as accessible and convenient (for the patient and provider) eHealth interventions. In this randomized controlled trial (RCT), Coping After Breast Cancer (CABC), 2 modified versions of the stress management eHealth intervention program StressProffen were created: one with predominantly cognitive behavioral stress management content (StressProffen-cognitive behavioral therapy intervention [StressProffen-CBI]) and another with predominantly mindfulness-based stress management content (StressProffen-mindfulness-based intervention [StressProffen-MBI]). Objective: This study aims to investigate the effects in breast cancer survivors of using StressProffen-CBI and StressProffen-MBI compared with a control group (treatment as usual). Methods: Women diagnosed with breast cancer (stage I-III, unequivocally human epidermal growth factor receptor 2–positive or estrogen receptor-negative tumors) or ductal carcinoma in situ (DCIS) aged 21-69 years who completed the Cancer Registry of Norway–initiated health survey on quality of life are invited to the CABC trial about 7 months after diagnosis. Women who give consent to participate are randomized (1:1:1) to either the StressProffen-CBI, StressProffen-MBI, or control group. Both StressProffen interventions consist of 10 modules of stress management content delivered through text, sound, video, and images. The primary outcome is between-group changes in perceived stress at 6 months, assessed with Cohen 10-item Perceived Stress Scale. The secondary outcomes comprise changes in quality of life, anxiety, depression, fatigue, sleep, neuropathy, coping, mindfulness, and work-related outcomes approximately 1, 2, and 3 years after diagnosis. Long-term effects of the interventions on work participation, comorbidities, relapse or new cancers, and mortality will be assessed using data from national health registries. Results: Recruitment is scheduled from January 2021 to May 2023. The goal is to recruit 430 participants (100 in each group). As of April 14 2023, 428 participants have been enrolled. Conclusions: The CABC trial is possibly the largest ongoing psychosocial eHealth RCT in patients with breast cancer. If 1 or both interventions prove to be effective in reducing stress and improving psychosocial and physical complains, the StressProffen eHealth interventions could be beneficial, inexpensive, and easily implementable tools for breast cancer survivors when coping with late effects after cancer and cancer treatments. Trial Registration: Clinicaltrials.gov NCT04480203; https://clinicaltrials.gov/ct2/show/NCT04480203 International Registered Report Identifier (IRRID): DERR1-10.2196/47195 %M 37103493 %R 10.2196/47195 %U https://www.researchprotocols.org/2023/1/e47195 %U https://doi.org/10.2196/47195 %U http://www.ncbi.nlm.nih.gov/pubmed/37103493 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46371 %T Evaluating the Effectiveness of Rural Digital Social Prescribing in Korea: Protocol for a Cohort Study %A Lee,Hocheol %A Koh,Sang Baek %A Jo,Heui Sug %A Lee,Tae Ho %A Nam,Hae Kweun %A Zhao,Bo %A Lim,Subeen %A Lim,Joo Aeh %A Lee,Ho Hee %A Hwang,Yu Seong %A Kim,Dong Hyun %+ Department of Health Administration, Software Digital Healthcare Convergence College, Yonsei University, Changjogwan 415Ho, Yonseidae-gil 1, Wonju, 26493, Republic of Korea, 82 01062861461, lhc0104@yonsei.ac.kr %K digital health %K digital social prescribing %K elderly health %K community health %K digital health intervention %D 2023 %7 24.5.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: The UK National Health Service (NHS) has introduced a digital social prescribing (DSP) system to improve the mental health of the aging population. In Korea, an ongoing pilot social prescribing project has been implemented for older individuals in rural areas since 2019. Objective: This research aims to develop a DSP program and to evaluate the effectiveness of the digital platform in rural areas of Korea. Methods: This study was designed as a prospective cohort method for the development and effectiveness evaluation of rural DSP in Korea. The study divided participants into four groups. Group 1 will continuously implement the existing social prescribing program, group 2 implemented the existing social prescribing program but was switched to DSP in 2023, group 3 newly started the DSP, and the remaining group is the control. The research area of this study is Gangwon Province in Korea. The study is being conducted in Wonju, Chuncheon, and Gangneung. This study will use indicators to measure depression, anxiety, loneliness, cognitive function, and digital literacy. In the future, the interventions will implement the digital platform and the Music Story Telling program. This study will evaluate the effectiveness of DSP using difference-in-differences regression and cost-benefit analysis. Results: This study was approved for funding from the National Research Foundation of Korea funded by the Ministry of Education in October 2022. The results of the data analysis are expected to be available in September 2023. Conclusions: The platform will be spread to rural areas in Korea and will serve as the foundation for effectively managing the feelings of solitude and depression among older individuals. This study will provide vital evidence for disseminating DSP in Asian countries such as Japan, China, Singapore, and Taiwan as well as for studying DSP in Korea. International Registered Report Identifier (IRRID): PRR1-10.2196/46371 %M 37223972 %R 10.2196/46371 %U https://www.researchprotocols.org/2023/1/e46371 %U https://doi.org/10.2196/46371 %U http://www.ncbi.nlm.nih.gov/pubmed/37223972 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e40236 %T A Virtual Reality–Assisted Cognitive Behavioral Therapy for and With Inuit in Québec: Protocol for a Proof-of-Concept Randomized Controlled Trial %A Seon,Quinta %A Mady,Noor %A Yang,Michelle %A Karia,Maharshee %A Lashley,Myrna %A Sescu,Claudia %A Lalonde,Maud %A Puskas,Stephen %A Outerbridge,Joy %A Parent-Racine,Echo %A Pagiatakis,Catherine %A Gomez-Cardona,Liliana %A Jiang,Di %A Bouchard,Stéphane %A Linnaranta,Outi %+ Finnish Institute for Health and Welfare, PO Box 30, Mannerheimintie 166, Helsinki, 00271, Finland, 358 295247517, outi.linnaranta@thl.fi %K Inuit health %K randomized controlled trial %K emotion regulation %K virtual reality %K cognitive behavioral therapy %K co-design %K biofeedback %K cultural adaptation %K Indigenous %D 2023 %7 24.5.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Emotion regulation is an ability related to psychological well-being; when dysregulated, individuals may have psychiatric symptoms and maladapted physiological responses. Virtual reality–assisted cognitive behavioral therapy (VR-CBT) is an effective psychotherapy to target and strengthen emotion regulation; however, it currently lacks cultural sensitivity and can be improved by adapting it to the cultural context of service users. During previous participatory research, we co-designed a culturally adapted cognitive behavioral therapy (CBT) manual and 2 virtual reality (VR) environments to function as a complement to therapy (VR-CBT) for Inuit who would like to access psychotherapy. Emotion regulation skill building will occur in virtual environments that have interactive components such as heart rate biofeedback. Objective: We describe a protocol for a proof-of-concept 2-arm randomized controlled trial (RCT) with Inuit (n=40) in Québec. The primary aims of this research are to investigate the feasibility, benefits, and challenges of the culturally adapted VR-CBT intervention versus an established VR self-management that is available commercially. We will also investigate self-rated mental well-being and objective psychophysiological measures. Finally, we will use proof-of-concept data to identify suitable primary outcome measures, conduct power calculations in a larger trial for efficacy, and collect information about preferences for on-site or at-home treatment. Methods: Trial participants will be randomly assigned to an active condition or active control condition in a 1:1 ratio. Inuit aged 14 to 60 years will receive a culturally adapted and therapist-guided VR-CBT with biofeedback or a VR relaxation program with nonpersonalized guided components over a 10-week period. We will collect pre- and posttreatment measures of emotion regulation and biweekly assessments over the treatment and at 3-month follow-up. The primary outcome will be measured by the Difficulties in Emotion Regulation Scale (DERS-16) and a novel psychophysiological reactivity paradigm. Secondary measures include psychological symptoms and well-being via rating scales (eg, anxiety or depressive symptoms). Results: As this is the prospective registration of an RCT protocol, we do not yet report any results from the trial. Funding was confirmed in January 2020, and recruitment is expected to start in March 2023 and is set to finish in August 2025. The expected results are to be published in spring 2026. Conclusions: The proposed study responds to the community’s desire for accessible and appropriate resources for psychological well-being, as it was developed in active collaboration with the Inuit community in Québec. We will test feasibility and acceptance by comparing a culturally adapted, on-site psychotherapy with a commercial self-management program while incorporating novel technology and measurement in the area of Indigenous health. We also aim to fulfill the needs for RCT evidence of culturally adapted psychotherapies that are lacking in Canada. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 21831510; https://www.isrctn.com/ISRCTN21831510 International Registered Report Identifier (IRRID): PRR1-10.2196/40236 %M 37223973 %R 10.2196/40236 %U https://www.researchprotocols.org/2023/1/e40236 %U https://doi.org/10.2196/40236 %U http://www.ncbi.nlm.nih.gov/pubmed/37223973 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e40193 %T Effectiveness of an Intervention Providing Digitally Generated Personalized Feedback and Education on Adherence to Continuous Positive Airway Pressure: Randomized Controlled Trial %A Lacroix,Joyca %A Tatousek,Jan %A Den Teuling,Niek %A Visser,Thomas %A Wells,Charles %A Wylie,Paul %A Rosenberg,Russell %A Bogan,Richard %+ Department of Digital Engagement, Cognition & Behavior, Philips Research, Eindhoven, Netherlands, High Tech Campus 34, Eindhoven, 5656 AE, Netherlands, 31 628041122, joyca.lacroix@philips.com %K therapy adherence %K personalized feedback %K personalized education %K tailored communication %K psychological profile %K continuous positive airway pressure therapy %K CPAP therapy %K obstructive sleep apnea %D 2023 %7 22.5.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Many people worldwide experience obstructive sleep apnea, which is associated with medical and psychological problems. Continuous positive airway pressure (CPAP) is an efficacious therapy for obstructive sleep apnea, but its effect is limited by nonadherence. Studies show that personalized education and feedback can increase CPAP adherence. Moreover, tailoring the style of information to the psychological profile of a patient has been shown to enhance the impact of interventions. Objective: This study aimed to assess the effect of an intervention providing digitally generated personalized education and feedback on CPAP adherence and the additional effect of tailoring the style of the education and feedback to an individual’s psychological profile. Methods: This study was a 90-day, multicenter, parallel, single-blinded, and randomized controlled trial with 3 conditions: personalized content in a tailored style (PT) in addition to usual care (UC), personalized content in a nontailored style (PN) in addition to UC, and UC. To test the effect of personalized education and feedback, the PN + PT group was compared with the UC group. To test the additional effect of tailoring the style to psychological profiles, the PN and PT groups were compared. Overall, 169 participants were recruited from 6 US sleep clinics. The primary outcome measures were adherence based on minutes of use per night and on nights of use per week. Results: We found a significant positive effect of personalized education and feedback on both primary adherence outcome measures. The difference in the estimated average adherence based on minutes of use per night between the PT + PN and UC groups on day 90 was 81.3 minutes in favor of the PT + PN group (95% CI −134.00 to −29.10; P=.002). The difference in the average adherence based on nights of use per week between the PT + PN and UC groups at week 12 was 0.9 nights per week in favor of the PT + PN group (difference in odds ratio 0.39, 95% CI 0.21-0.72; P=.003). We did not find an additional effect of tailoring the style of the intervention to psychological profiles on the primary outcomes. The difference in nightly use between the PT and PN groups on day 90 (95% CI −28.20 to 96.50; P=.28) and the difference in nights of use per week between the PT and PN groups at week 12 (difference in odds ratio 0.85, 95% CI 0.51-1.43; P=.054) were both nonsignificant. Conclusions: The results show that personalized education and feedback can increase CPAP adherence substantially. Tailoring the style of the intervention to the psychological profiles of patients did not further increase adherence. Future research should investigate how the impact of interventions can be enhanced by catering to differences in psychological profiles. Trial Registration: ClinicalTrials.gov NCT02195531; https://clinicaltrials.gov/ct2/show/NCT02195531 %M 37213195 %R 10.2196/40193 %U https://www.jmir.org/2023/1/e40193 %U https://doi.org/10.2196/40193 %U http://www.ncbi.nlm.nih.gov/pubmed/37213195 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44484 %T Technology-Assisted Cognitive Motor Dual-Task Rehabilitation in Chronic Age-Related Conditions: Systematic Review %A Tuena,Cosimo %A Borghesi,Francesca %A Bruni,Francesca %A Cavedoni,Silvia %A Maestri,Sara %A Riva,Giuseppe %A Tettamanti,Mauro %A Liperoti,Rosa %A Rossi,Lorena %A Ferrarin,Maurizio %A Stramba-Badiale,Marco %+ Applied Technology for Neuro-Psychology Lab, Istituto Auxologico Italiano, Istituto di Ricovero e Cura a Carattere Scientifico, Via Alessandro Magnasco 2, Milan, 20145, Italy, 39 02619112726, c.tuena@auxologico.it %K dementia %K Parkinson disease %K falls %K virtual reality %K dual-task %K aging %K rehabilitation %D 2023 %7 22.5.2023 %9 Review %J J Med Internet Res %G English %X Background: Cognitive-motor dual-task (CMDT) is defined as the parallel processing of motor (eg, gait) and cognitive (eg, executive functions) activities and is an essential ability in daily life. Older adults living with frailty, chronic conditions (eg, neurodegenerative diseases), or multimorbidity pay high costs during CMDT. This can have serious consequences on the health and safety of older adults with chronic age-related conditions. However, CMDT rehabilitation can provide useful and effective therapies for these patients, particularly if delivered through technological devices. Objective: This review aims to describe the current technological applications, CMDT rehabilitative procedures, target populations, condition assessment, and efficacy and effectiveness of technology-assisted CMDT rehabilitation in chronic age-related conditions. Methods: We performed this systematic review, following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, on 3 databases (Web of Science, Embase, and PubMed). Original articles that were published in English; involved older adults (>65 years) with ≥1 chronic condition and/or frailty; and tested, with a clinical trial, a technology-assisted CMDT rehabilitation against a control condition were included. Risk of bias (Cochrane tool) and the RITES (Rating of Included Trials on the Efficacy-Effectiveness Spectrum) tool were used to evaluate the included studies. Results: A total of 1097 papers were screened, and 8 (0.73%) studies met the predefined inclusion criteria for this review. The target conditions for technology-assisted CMDT rehabilitation included Parkinson disease and dementia. However, little information regarding multimorbidity, chronicity, or frailty status is available. The primary outcomes included falls, balance, gait parameters, dual-task performance, and executive functions and attention. CMDT technology mainly consists of a motion-tracking system combined with virtual reality. CMDT rehabilitation involves different types of tasks (eg, obstacle negotiation and CMDT exercises). Compared with control conditions, CMDT training was found to be pleasant, safe, and effective particularly for dual-task performances, falls, gait, and cognition, and the effects were maintained at midterm follow-up. Conclusions: Despite further research being mandatory, technology-assisted CMDT rehabilitation is a promising method to enhance motor-cognitive functions in older adults with chronic conditions. %M 37213200 %R 10.2196/44484 %U https://www.jmir.org/2023/1/e44484 %U https://doi.org/10.2196/44484 %U http://www.ncbi.nlm.nih.gov/pubmed/37213200 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e42590 %T Impact of Multimedia Messaging Service Education and Exercise Social Support on Physical Activity Among Patients With Type 2 Diabetes: Quasi-Experimental Study %A Alyahya,Mohammad S %A Al-Sheyab,Nihaya A %A Khader,Yousef S %A Alqudah,Jumana A %+ Health Management and Policy, Faulty of Medicine, Jordan University of Science and Technology (JUST), 22110, Irbid, 3030, Jordan, 962 775582824, msalyahya@just.edu.jo %K diabetes mellitus %K educational interventions %K multimedia messaging service %K physical activity %K social support %D 2023 %7 22.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Social support is one of the interpersonal stimuli that define an individual’s predisposition to engage in health-promoting behaviors and is considered a facilitator in improving health habits. Patients with type 2 diabetes mellitus (T2DM) can benefit from educating supportive families and friends on self-care management including exercise behavior. Multimedia messaging service (MMS) could also be an effective method for delivering targeted educational interventions that focus on physical activity (PA). Objective: This study aimed to assess the effectiveness of MMS educational interventions and perceived social support for exercise on level of PA of patients with T2DM. Methods: A quasi-experimental pretest-posttest design was conducted to recruit 98 patients with T2DM. The intervention group received MMS education aiming to improve exercise social support and PA level for 2 months, and their counterparts in the control group received the usual routine care. We sent 2 to 3 messages daily for 2 weeks from Saturday to Thursday (12 days total). These messages were a combination of videos and texts, and the evidence-based content of these messages was reviewed and approved by the advisory committee. We randomly assigned eligible patients in a 1:1 ratio into the intervention or the control groups. Participants completed a survey in 3 periods. Results: There were no significant differences in friends’ support, family verbal, practical, or emotional support over time in the intervention group (P>.05). Yet, there was a small effect size (Cohen d) in friends’ social support (0.389), family practical support (0.271), and moderate activities (0.386). A medium effect size was found in family verbal (0.463) and emotional (0.468) support. Being married increased the likelihood of friends’ support by 2.3 times after intervention (P=.04), whereas rarely doing exercise decreased the likelihood of friends’ support by 28% (P=.03) and family practical support by 28% (P=.01). Being female and married increased the likelihood of doing moderate activities by 1.6 times (P=.002) and 1.5 times (P=.049) in the intervention group. Being a housewife decreased the likelihood of doing moderate activities by 20% (P=.001). Finally, being a female with a higher educational level decreased the likelihood of doing hard activities by 20% (P=.04) and 15% (P=.002), respectively. Conclusions: A theoretically based MMS health education targeting PA levels and social support of family and friends to perform PA seems promising in promoting family and friends’ social support and improving PA levels among patients with T2DM. Actively involving family and friends in educational interventions that target PA can have an impact on health-promoting behaviors in patients with diabetes. %M 37213171 %R 10.2196/42590 %U https://formative.jmir.org/2023/1/e42590 %U https://doi.org/10.2196/42590 %U http://www.ncbi.nlm.nih.gov/pubmed/37213171 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42729 %T Understanding the Uptake and Outcomes of Non-occupational Postexposure Prophylaxis Use Through an Online Medical Platform in China: Web-Based Cross-sectional Study %A Shan,Duo %A Xue,Hui %A Yu,Fei %A Zan,Xingkai %A Liu,Hui %A Liu,Jiaye %A Han,Mengjie %A Zhang,Dapeng %+ National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, 155 Changbai Road, Changping District, Beijing, Beijing, 102206, China, 86 1058900964, zhangdapeng@chinaaids.cn %K online medical platform %K men who have sex with men %K postexposure prophylaxis %K preexposure prophylaxis %K PrEP %K sexual behaviors %K HIV %K risk %K prevention %D 2023 %7 19.5.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: To date, non-occupational postexposure prophylaxis (PEP) has been widely accepted as a safe and effective intervention for HIV in many countries, yet it remains an underutilized prevention strategy in China. Evidence indicated a high demand for PEP among Chinese men who have sex with men, but the uptake and access to PEP service remain limited. In an era of rapid development of web-based technology, online medical platforms in China hold great promise in facilitating PEP provision and delivery by addressing problems such as accessibility, convenience, privacy protection, and antidiscrimination by integrating online and offline resources. However, there is a paucity of data concerning the uptake and outcomes of online PEP in China. Objective: The aim of this study is to explore online PEP service provision and understand PEP uptake and outcome through a web-based cross-sectional study. Methods: From January 2020 to June 2021, we conducted a retrospective web-based survey among those seeking online PEP services via the internet medical platform “HeHealth” using a structured questionnaire. Participants were surveyed on sociodemographic characteristics, sexual and drug-related behaviors, history of preexposure prophylaxis (PrEP) usage, and PEP uptake. Statistical analysis included descriptive analysis, chi-square test, and multivariable logistic regression. P values <.05 were deemed statistically significant. Results: No HIV seroconversions were observed among 539 PEP users. Our sample demonstrated that most participants seeking online PEP services were gay (397/539, 73.7%), single (470/539, 87.2%), having an education of more than 12 years (493/539, 91.5%), and with an average monthly income of 7000 RMB (1 RMB=US $0.14) or more (274/539, 50.8%). Sexual exposures accounted for 86.8% (468/539) of the cases, with anal sex being the most common indication (389/539, 72.2%) for seeking PEP use. Among 539 participants, 60.7% (327/539) sought online PEP for relatively low-risk exposures, whereas 39.3% (212/539) were considered high-risk exposures. Nearly all (537/539, 99.6%) initiated PEP within 72 hours and 68.6% (370/539) within 24 hours of exposure. All users (539/539) were prescribed a 3-drug regimen, with most comprising 3TC/TDF+DTG (lamivudine, tenofovir disoproxil fumarate, and dolutegravir; 293/539, 54.4%), followed by FTC/TDF+DTG (emtricitabine, tenofovir disoproxil fumarate, and dolutegravir; 158/539, 29.3%). The adjusted model showed that greater odds of PrEP usage were associated with an age of 35 years or older versus the age group of 25-34 years (adjusted odds ratio [AOR] 2.04, 95% CI 1.24-3.37), having an education of 17 years or more versus an education of 12 years or less (AOR 3.14, 95% CI 1.29-7.62), average monthly income of 20,000 RMB or more versus less than 3000 RMB (AOR 2.60, 95% CI 1.09-6.23), and having high-risk sexual behavior during PEP treatment (AOR 2.20, 95% CI 1.05, 3.69). Conclusions: The 0% infection rate in this study demonstrated that online PEP could be a valuable risk-reduction option to improve HIV prevention service within China. However, further research is needed to better facilitate PrEP transition among online PEP users. %M 37204828 %R 10.2196/42729 %U https://www.jmir.org/2023/1/e42729 %U https://doi.org/10.2196/42729 %U http://www.ncbi.nlm.nih.gov/pubmed/37204828 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e44535 %T Acceptability and Potential Impact of the #chatsafe Suicide Postvention Response Among Young People Who Have Been Exposed to Suicide: Pilot Study %A La Sala,Louise %A Pirkis,Jane %A Cooper,Charlie %A Hill,Nicole T M %A Lamblin,Michelle %A Rajaram,Gowri %A Rice,Simon %A Teh,Zoe %A Thorn,Pinar %A Zahan,Rifat %A Robinson,Jo %+ Orygen, Centre for Youth Mental Health, The University of Melbourne, 35 Poplar Road, Parkville, 3052, Australia, 61 3 9966 9512, louise.lasala@orygen.org.au %K youth %K suicide %K social media %K suicide postvention %K suicide prevention %K contagion %K postvention %D 2023 %7 19.5.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Young people are more likely to be affected by suicide contagion, and there are concerns about the role social media plays in the development and maintenance of suicide clusters or in facilitating imitative suicidal behavior. However, social media also presents an opportunity to provide real-time and age-appropriate suicide prevention information, which could be an important component of suicide postvention activities. Objective: This study aimed to test an intervention designed to equip young people to communicate safely online about suicide (#chatsafe) with a sample of young people who had recently been exposed to a suicide or suicide attempt, with a view to determining the role social media can play as part of a postvention response. Methods: A sample of 266 young people from Australia, aged 16 to 25 years, were recruited to participate in the study. They were eligible if they had been exposed to a suicide or knew of a suicide attempt in the past 2 years. All participants received the #chatsafe intervention, which comprised 6 pieces of social media content that were sent to them weekly via direct message through Instagram, Facebook, or Snapchat. Participants were assessed on a range of outcome measures (social media use, willingness to intervene against suicide, internet self-efficacy, confidence, and safety when communicating about suicide on social media platforms) at baseline, immediately after the intervention, and at 4-week follow-up. Results: After the 6-week #chatsafe intervention, participants reported substantial improvements in their willingness to intervene against suicide online, their internet self-efficacy, and their perceived confidence and safety when communicating about suicide online. Overall, the participants reported that it was appropriate to receive the #chatsafe intervention via social media, and no iatrogenic effects were recorded. Conclusions: The findings suggest that it is safe and acceptable to disseminate suicide prevention information entirely via social media among young people who have recently been exposed to a suicide or suicide attempt. Interventions such as #chatsafe could potentially mitigate the risk of distress and future suicidal behavior in young people by improving the quality and safety of online communication about suicide and, as such, can be an important component of delivering a postvention response to young people. %M 37204854 %R 10.2196/44535 %U https://humanfactors.jmir.org/2023/1/e44535 %U https://doi.org/10.2196/44535 %U http://www.ncbi.nlm.nih.gov/pubmed/37204854 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46157 %T Evaluating the Efficacy of Web-Based Cognitive Behavioral Therapy for the Treatment of Patients With Bipolar II Disorder and Residual Depressive Symptoms: Protocol for a Randomized Controlled Trial %A Gutierrez,Gilmar %A Stephenson,Callum %A Eadie,Jazmin %A Moghimi,Elnaz %A Omrani,Mohsen %A Groll,Dianne %A Soares,Claudio N %A Milev,Roumen %A Vazquez,Gustavo %A Yang,Megan %A Alavi,Nazanin %+ Department of Psychiatry, Queen's University, 166 Brock St, Kingston, ON, K7L5G2, Canada, 1 6135443310, nazanin.alavitabari@kingstonhsc.ca %K bipolar disorder %K cognitive behavioral therapy %K depression %K eHealth %K electronic care %K internet %K mental health %K psychotherapy %K treatment %K web-based therapy %D 2023 %7 19.5.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Bipolar disorder (BD) is a highly prevalent psychiatric condition that can significantly impact every aspect of a person’s life if left untreated. A subtype of BD, bipolar disorder type II (BD-II), is characterized by long depressive episodes and residual depression symptoms, with short-lived hypomanic episodes. Medication and psychotherapy, such as cognitive behavioral therapy (CBT), are the main treatment options for BD-II. CBT specific for BD-II involves the recognition of warning signs, potentially triggering stimuli, and the development of coping skills to increase euthymic periods and improve global functioning. However, access to in-person CBT may be limited by several barriers, including low availability, high costs, and geographical limitations. Thus, web-based adaptations of CBT (e-CBT) have become a promising solution to address these treatment barriers. Nevertheless, e-CBT for the treatment of BD-II remains understudied. Objective: The proposed study aims to establish the first e-CBT program specific for the treatment of BD-II with residual depressive symptoms. The primary objective of this study will be to determine the effect of e-CBT in managing BD symptomatology. The secondary objective will be to assess the effects of this e-CBT program on quality of life and resilience. The tertiary objective will involve gathering user feedback using a posttreatment survey to support the continuous improvement and optimization of the proposed program. Methods: Adult participants (N=170) with a confirmed diagnosis of BD-II experiencing residual depressive symptoms will be randomly assigned to either the e-CBT and treatment as usual (TAU; n=85) group or the TAU (n=85) control group. Participants in the control group will be able to participate in the web-based program after the first 13 weeks. The e-CBT program will consist of 13 weekly web-based modules designed following a validated CBT framework. Participants will complete module-related homework and receive asynchronous personalized feedback from a therapist. TAU will consist of standard treatment services conducted outside of this research study. Depression and manic symptoms, quality of life, and resiliency will be assessed using clinically validated symptomatology questionnaires at baseline, week 6, and week 13. Results: The study received ethics approval in March 2020, and participant recruitment is expected to begin in February 2023 through targeted advertisements and physician referrals. Data collection and analysis are expected to conclude by December 2024. Linear and binomial regression (continuous and categorical outcomes, respectively) will be conducted along with qualitative interpretive methods. Conclusions: The findings will be the first on the effectiveness of delivering e-CBT for patients with BD-II with residual depressive symptoms. This approach can provide an innovative method to address barriers to in-person psychotherapy by increasing accessibility and decreasing costs. Trial Registration: ClinicalTrials.gov NCT04664257; https://clinicaltrials.gov/ct2/show/NCT04664257 International Registered Report Identifier (IRRID): PRR1-10.2196/46157 %M 37140460 %R 10.2196/46157 %U https://www.researchprotocols.org/2023/1/e46157 %U https://doi.org/10.2196/46157 %U http://www.ncbi.nlm.nih.gov/pubmed/37140460 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45652 %T Feasibility, Usability, and Safety of ParaGym, an Intelligent Mobile Exercise App for Individuals With Paraplegia: Protocol for a Pilot Block-Randomized Controlled Trial %A Bolz,Janika %A Löscher,Adrian %A Muhl,Rainer %A Badke,Andreas %A Predel,Hans-Georg %A Perret,Claudio %+ Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, Am Sportpark Müngersdorf 6, Cologne, 50933, Germany, 49 22149825271, j.bolz@dshs-koeln.de %K spinal cord injury %K mixed methods %K exercise %K fitness %K home-based %K algorithm %K personalization %K prototype %K telemedicine %K digital %K mobile app %K mobile phone %D 2023 %7 19.5.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Exercise is crucial for individuals with paraplegia to reduce the risk of secondary diseases and improve independence and quality of life. However, numerous barriers such as inadequate accessibility restrict their participation in exercise programs. Digital exercise apps can help overcome these barriers. Personalization is considered a crucial feature of mobile exercise apps, as people with paraplegia have individual requirements regarding exercise programs depending on their level of impairment. Despite the increasing popularity of mobile exercise apps, there are none available that target the individual needs of this cohort. The ParaGym mobile exercise app prototype was designed to automatically tailor exercise sessions to the individual needs of users with paraplegia. Objective: This study aims to evaluate the feasibility, usability, safety, and preliminary effectiveness of the ParaGym mobile exercise app prototype. Methods: This pilot block-randomized controlled feasibility trial will include 45 adult participants with paraplegia. Eligible participants will be block randomized to either the intervention or waitlist control group. The intervention group will perform a 6-week exercise program using the ParaGym mobile exercise app, comprising three 35-minute exercise sessions per week. The waitlist control group will continue their usual care and receive access to the app after study completion. Participants will record all exercise sessions conducted with the app as well as additional exercise sessions conducted during the study period using exercise diaries. The primary outcomes include feasibility, usability, and safety. Feasibility will be assessed through semistructured interviews, study adherence, and retention rates. Usability will be measured using the System Usability Scale. Safety will be determined by the occurrence of adverse events. Secondary outcomes include the effects of the intervention on peak exercise capacity (VO2 peak); handgrip strength; independence, which will be measured using the Spinal Cord Independence Measure III (SCIM III); and health-related quality of life, which will be measured using the Short Form–36 Health Survey (SF-36). Results: Recruitment commenced in November 2022. Overall, 12 participants were enrolled at the time of submission. Data collection commenced in January 2023, with completion expected in April 2023. Conclusions: To the best of our knowledge, this is the first study to assess the feasibility, usability, and safety of an intelligent mobile exercise app for individuals with paraplegia. Thereafter, the app should be adapted according to the findings of this trial. Future trials with an updated version of the app should aim for a larger sample size, longer intervention duration, and more diverse target group. In the long term, a fully marketable version of the ParaGym app should be implemented. This would increase the access to personalized, independent, and evidence-based exercise training for this cohort and, in the future, other people who use wheelchairs. Trial Registration: German Clinical Trials Register DRKS00030370; https://drks.de/search/de/trial/DRKS00030370 International Registered Report Identifier (IRRID): DERR1-10.2196/45652 %M 37204855 %R 10.2196/45652 %U https://www.researchprotocols.org/2023/1/e45652 %U https://doi.org/10.2196/45652 %U http://www.ncbi.nlm.nih.gov/pubmed/37204855 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44352 %T Using Digital Technology to Quantify Habitual Physical Activity in Community Dwellers With Cognitive Impairment: Systematic Review %A Mc Ardle,Ríona %A Jabbar,Khalid Abdul %A Del Din,Silvia %A Thomas,Alan J %A Robinson,Louise %A Kerse,Ngaire %A Rochester,Lynn %A Callisaya,Michele %+ Newcastle University, Room 3.27, The Catalyst, 3 Science Square, Newcastle Helix, Newcastle, NE4 5TG, United Kingdom, 44 7476700757, riona.mcardle@ncl.ac.uk %K dementia %K cognitive dysfunction %K physical activity %K digital technology %K wearable electronic devices %K remote sensing technology %K systematic review %K community %K wearables %K cognitive impairment %K support %K clinicians %K sensing %D 2023 %7 18.5.2023 %9 Review %J J Med Internet Res %G English %X Background: Participating in habitual physical activity (HPA) can support people with dementia and mild cognitive impairment (MCI) to maintain functional independence. Digital technology can continuously measure HPA objectively, capturing nuanced measures relating to its volume, intensity, pattern, and variability. Objective: To understand HPA participation in people with cognitive impairment, this systematic review aims to (1) identify digital methods and protocols; (2) identify metrics used to assess HPA; (3) describe differences in HPA between people with dementia, MCI, and controls; and (4) make recommendations for measuring and reporting HPA in people with cognitive impairment. Methods: Key search terms were input into 6 databases: Scopus, Web of Science, Psych Articles, PsychInfo, MEDLINE, and Embase. Articles were included if they included community dwellers with dementia or MCI, reported HPA metrics derived from digital technology, were published in English, and were peer reviewed. Articles were excluded if they considered populations without dementia or MCI diagnoses, were based in aged care settings, did not concern digitally derived HPA metrics, or were only concerned with physical activity interventions. Key outcomes extracted included the methods and metrics used to assess HPA and differences in HPA outcomes across the cognitive spectrum. Data were synthesized narratively. An adapted version of the National Institute of Health Quality Assessment Tool for Observational Cohort and Cross-sectional Studies was used to assess the quality of articles. Due to significant heterogeneity, a meta-analysis was not feasible. Results: A total of 3394 titles were identified, with 33 articles included following the systematic review. The quality assessment suggested that studies were moderate-to-good quality. Accelerometers worn on the wrist or lower back were the most prevalent methods, while metrics relating to volume (eg, daily steps) were most common for measuring HPA. People with dementia had lower volumes, intensities, and variability with different daytime patterns of HPA than controls. Findings in people with MCI varied, but they demonstrated different patterns of HPA compared to controls. Conclusions: This review highlights limitations in the current literature, including lack of standardization in methods, protocols, and metrics; limited information on validity and acceptability of methods; lack of longitudinal research; and limited associations between HPA metrics and clinically meaningful outcomes. Limitations of this review include the exclusion of functional physical activity metrics (eg, sitting/standing) and non-English articles. Recommendations from this review include suggestions for measuring and reporting HPA in people with cognitive impairment and for future research including validation of methods, development of a core set of clinically meaningful HPA outcomes, and further investigation of socioecological factors that may influence HPA participation. Trial Registration: PROSPERO CRD42020216744; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=216744   %M 37200065 %R 10.2196/44352 %U https://www.jmir.org/2023/1/e44352 %U https://doi.org/10.2196/44352 %U http://www.ncbi.nlm.nih.gov/pubmed/37200065 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e40213 %T Social Prescription Interventions Addressing Social Isolation and Loneliness in Older Adults: Meta-Review Integrating On-the-Ground Resources %A Paquet,Catherine %A Whitehead,Jocelyne %A Shah,Rishabh %A Adams,Alayne Mary %A Dooley,Damion %A Spreng,R Nathan %A Aunio,Anna-Liisa %A Dubé,Laurette %+ Département de Marketing, Faculté des Sciences de l'Administration, Université Laval, 2325, rue de la Terrasse, Québec, QC, G1V 0A6, Canada, 1 418 656 2131 ext 404122, catherine.paquet@fsa.ulaval.ca %K social prescription %K social isolation %K loneliness %K intervention %K older adults %K knowledge mobilization %K database management %K ontology %D 2023 %7 17.5.2023 %9 Review %J J Med Internet Res %G English %X Background: Social prescription programs represent a viable solution to linking primary care patients to nonmedical community resources for improving patient well-being. However, their success depends on the integration of patient needs with local resources. This integration could be accelerated by digital tools that use expressive ontology to organize knowledge resources, thus enabling the seamless navigation of diverse community interventions and services tailored to the needs of individual users. This infrastructure bears particular relevance for older adults, who experience a range of social needs that impact their health, including social isolation and loneliness. An essential first step in enabling knowledge mobilization and the successful implementation of social prescription initiatives to meet the social needs of older adults is to incorporate the evidence-based academic literature on what works, with on-the-ground solutions in the community. Objective: This study aims to integrate scientific evidence with on-the-ground knowledge to build a comprehensive list of intervention terms and keywords related to reducing social isolation and loneliness in older adults. Methods: A meta-review was conducted using a search strategy combining terms related to older adult population, social isolation and loneliness, and study types relevant to reviews using 5 databases. Review extraction included intervention characteristics, outcomes (social [eg, loneliness, social isolation, and social support] or mental health [eg, psychological well-being, depression, and anxiety]), and effectiveness (reported as consistent, mixed, or not supported). Terms related to identified intervention types were extracted from the reviewed literature as well as descriptions of corresponding community services in Montréal, Canada, available from web-based regional, municipal, and community data sources. Results: The meta-review identified 11 intervention types addressing social isolation and loneliness in older adults by either increasing social interactions, providing instrumental support, promoting mental and physical well-being, or providing home and community care. Group-based social activities, support groups with educational elements, recreational activities, and training or use of information and communication technologies were the most effective in improving outcomes. Examples of most intervention types were found in community data sources. Terms derived from the literature that were the most commonly congruent with those describing existing community services were related to telehealth, recreational activities, and psychological therapy. However, several discrepancies were observed between review-based terms and those addressing the available services. Conclusions: A range of interventions found to be effective at addressing social isolation and loneliness or their impact on mental health were identified from the literature, and many of these interventions were represented in services available to older residents in Montréal, Canada. However, different terms were occasionally used to describe or categorize similar services across data sources. Establishing an efficient means of identifying and structuring such sources is important to facilitate referrals and help-seeking behaviors of older adults and for strategic planning of resources. %M 37195738 %R 10.2196/40213 %U https://www.jmir.org/2023/1/e40213 %U https://doi.org/10.2196/40213 %U http://www.ncbi.nlm.nih.gov/pubmed/37195738 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e43780 %T The Impact of a Messenger-Based Psychosocial Chat Counseling Service on Further Help-Seeking Among Children and Young Adults: Longitudinal Study %A Baldofski,Sabrina %A Kohls,Elisabeth %A Efe,Zeki %A Eckert,Melanie %A Saee,Shadi %A Thomas,Julia %A Wundrack,Richard %A Rummel-Kluge,Christine %+ Department of Psychiatry and Psychotherapy, Medical Faculty, Leipzig University, Semmelweisstr 10, Haus 13, Leipzig, 04103, Germany, 49 3419724464, christine.rummel-kluge@medizin.uni-leipzig.de %K online intervention %K e-mental health %K online chat %K hotline %K text-based %K children %K adolescents %K young adults %K psychopathology %K help-seeking %D 2023 %7 17.5.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Mental crises have high prevalences in adolescence. Early interventions appear to be highly important to diminish the risk of the deterioration, recurrence, or chronification of symptoms. In recent years, various providers have started offering live chat support in psychological crises. The messenger-based psychological counseling service krisenchat aims to support young people in crises and, if necessary, provide a recommendation for a referral to the health care system or to seek further help from a trusted adult person. Objective: This study aimed to investigate the impact of using the counseling service of krisenchat on the further help-seeking behavior of young people, and to identify associated factors of further help-seeking. Methods: This longitudinal study analyzed anonymous data from 247 individuals who used krisenchat between October 2021 and March 2022, and received a recommendation for further help-seeking. An online survey directly after the chat assessed the perceived helpfulness of the chat and well-being after the chat. After 4 weeks, further help-seeking, facilitators and barriers to help-seeking, and self-efficacy were assessed in an online follow-up survey. Results: The most frequently recommended services or persons to seek further help from included a psychotherapist or social psychiatric service (75/225, 33.3%), a school psychologist or school social worker (52/225, 23.1%), and the user’s parents (45/225, 20.0%). Of the 247 users, 120 (48.6%) indicated that they contacted the recommended service or person, and of these, 87 (72.5%) stated that they already had an appointment (or talk) with the respective service or person or that an appointment (or talk) was scheduled. The most frequently reported facilitators for further help-seeking were mental health literacy (54/120, 45.0%), improvement of self-efficacy (55/120, 45.8%), and symptom recognition (40/120, 33.3%). In users not displaying further help-seeking behavior, the most frequent barriers included stigmatization (60/127, 47.2%), lack of mental health literacy (59/127, 46.5%), need for self-reliance and autonomy (53/127, 41.7%), and negative family beliefs regarding help services (53/127, 41.7%). Subgroup comparisons indicated significantly higher levels of self-efficacy in users displaying further help-seeking behavior than in those not displaying further help-seeking behavior. Both subgroups did not differ in gender, age, recommended service or person, chat topics, perceived helpfulness, and well-being. Conclusions: The findings of this study indicate that children and young adults receiving counseling on krisenchat benefit in terms of seeking further help. Further help-seeking seems to be associated with higher levels of self-efficacy. Trial Registration: Deutsches Register Klinischer Studien DRKS00026671; https://tinyurl.com/4fm5xe68 %M 37195747 %R 10.2196/43780 %U https://mental.jmir.org/2023/1/e43780 %U https://doi.org/10.2196/43780 %U http://www.ncbi.nlm.nih.gov/pubmed/37195747 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e44792 %T Using Human-Centered Design and Cocreation to Create the Live 5-2-1-0 Mobile App to Promote Healthy Behaviors in Children: App Design and Development %A Yau,Kiana W %A Tang,Tricia S %A Görges,Matthias %A Pinkney,Susan %A Amed,Shazhan %+ Research Institute, BC Children's Hospital, A4-196, 950 W 28th Ave, Vancouver, BC, V5Z 4H4, Canada, 1 6048753113, SAmed@cw.bc.ca %K childhood obesity %K mobile health %K health behaviors %K prevention %K mobile health app %K mHealth app %K human-centered design %K cocreation %K participatory approach %K mobile phone %D 2023 %7 17.5.2023 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: The prevalence of obesity among Canadian children is rising, partly because of increasingly obesogenic environments that limit opportunities for physical activity and healthy nutrition. Live 5-2-1-0 is a community-based multisectoral childhood obesity prevention initiative that engages stakeholders to promote and support the message of consuming ≥5 servings of vegetables and fruits, having <2 hours of recreational screen time, participating in ≥1 hour of active play, and consuming 0 sugary drinks every day. A Live 5-2-1-0 Toolkit for health care providers (HCPs) was previously developed and piloted in 2 pediatric clinics at British Columbia Children’s Hospital. Objective: This study aimed to co-create, in partnership with children, parents, and HCPs, a Live 5-2-1-0 mobile app that supports healthy behavior change and could be used as part of the Live 5-2-1-0 Toolkit for HCPs. Methods: Three focus groups (FGs) were conducted using human-centered design and participatory approaches. In FG 1, children (separately) and parents and HCPs (together) participated in sessions on app conceptualization and design. Researchers and app developers analyzed and interpreted qualitative data from FG 1 in an ideation session, and key themes were subsequently presented separately to parents, children, and HCPs in FG-2 (co-creation) sessions to identify desired app features. Parents and children tested a prototype in FG 3, provided feedback on usability and content, and completed questionnaires. Thematic analysis and descriptive statistics were used for the qualitative and quantitative data, respectively. Results: In total, 14 children (mean age 10.2, SD 1.3 years; 5/14, 36% male; 5/14, 36% White), 12 parents (9/12, 75% aged 40-49 years; 2/12, 17% male; 7/12, 58% White), and 18 HCPs participated; most parents and children (20/26, 77%) participated in ≥2 FGs. Parents wanted an app that empowered children to adopt healthy behaviors using internal motivation and accountability, whereas children described challenge-oriented goals and family-based activities as motivating. Parents and children identified gamification, goal setting, daily steps, family-based rewards, and daily notifications as desired features; HCPs wanted baseline behavior assessments and to track users’ behavior change progress. Following prototype testing, parents and children reported ease in completing tasks, with a median score of 7 (IQR 6-7) on a 7-point Likert scale (1=very difficult; 7=very easy). Children liked most suggested rewards (28/37, 76%) and found 79% (76/96) of suggested daily challenges (healthy behavior activities that users complete to achieve their goal) realistic to achieve. Participant suggestions included strategies to maintain users’ interest and content that further motivates healthy behavior change. Conclusions: Co-creating a mobile health app with children, parents, and HCPs was feasible. Stakeholders desired an app that facilitated shared decision-making with children as active agents in behavior change. Future research will involve clinical implementation and assessment of the usability and effectiveness of the Live 5-2-1-0 app. %M 37195754 %R 10.2196/44792 %U https://pediatrics.jmir.org/2023/1/e44792 %U https://doi.org/10.2196/44792 %U http://www.ncbi.nlm.nih.gov/pubmed/37195754 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e43065 %T Mobile Acceptance and Commitment Therapy With Distressed First-Generation College Students: Microrandomized Trial %A Thomas,Emily Brenny Kroska %A Sagorac Gruichich,Tijana %A Maronge,Jacob M %A Hoel,Sydney %A Victory,Amanda %A Stowe,Zachary N %A Cochran,Amy %+ Department of Psychological and Brain Sciences, University of Iowa, 340 Iowa Avenue, G60 PBSB, Iowa City, IA, 52242, United States, 1 319 467 1691, emily-kroska@uiowa.edu %K acceptance and commitment therapy %K randomized controlled trials %K mobile health %K mHealth %K first-generation college students %K psychological flexibility %K distress %K depression %D 2023 %7 15.5.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Extant gaps in mental health services are intensified among first-generation college students. Improving access to empirically based interventions is critical, and mobile health (mHealth) interventions are growing in support. Acceptance and commitment therapy (ACT) is an empirically supported intervention that has been applied to college students, via mobile app, and in brief intervals. Objective: This study evaluated the safety, feasibility, and effectiveness of an ACT-based mHealth intervention using a microrandomized trial (MRT) design. Methods: Participants (N=34) were 18- to 19-year-old first-generation college students reporting distress, who participated in a 6-week intervention period of twice-daily assessments and randomization to intervention. Participants logged symptoms, moods, and behaviors on the mobile app Lorevimo. After the assessment, participants were randomized to an ACT-based intervention or no intervention. Analyses examined proximal change after randomization using a weighted and centered least squares approach. Outcomes included values-based and avoidance behavior, as well as depressive symptoms and perceived stress. Results: The findings indicated the intervention was safe and feasible. The intervention increased values-based behavior but did not decrease avoidance behavior. The intervention reduced depressive symptoms but not perceived stress. Conclusions: An MRT of an mHealth ACT-based intervention among distressed first-generation college students suggests that a larger MRT is warranted. Future investigations may tailor interventions to contexts where intervention is most impactful. Trial Registration: ClinicalTrials.gov NCT04081662; https://clinicaltrials.gov/show/NCT04081662 International Registered Report Identifier (IRRID): RR2-10.2196/17086 %M 37184896 %R 10.2196/43065 %U https://mental.jmir.org/2023/1/e43065 %U https://doi.org/10.2196/43065 %U http://www.ncbi.nlm.nih.gov/pubmed/37184896 %0 Journal Article %@ 2369-3762 %I JMIR Publications %V 9 %N %P e40716 %T Observed Interactions, Challenges, and Opportunities in Student-Led, Web-Based Near-Peer Teaching for Medical Students: Interview Study Among Peer Learners and Peer Teachers %A Chan,Evelyn Hui Yi %A Chan,Vernice Hui Yan %A Roed,Jannie %A Chen,Julie Yun %+ Department of Family Medicine and Primary Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 3/F Ap Lei Chau Clinic, 161 Main St, Ap Lei Chau, Hong Kong, Hong Kong, 852 2518 5657, juliechen@hku.hk %K peer teaching %K peer-assisted learning %K medical student %K medical education %K web-based education %K distance learning %D 2023 %7 15.5.2023 %9 Original Paper %J JMIR Med Educ %G English %X Background: Near-peer teaching (NPT) is becoming an increasingly popular pedagogical tool in health professions education. Despite the shift in formal medical education from face-to-face teaching toward encompassing web-based learning activities, NPT has not experienced a similar transition. Apart from the few reports on NPT programs hastily converted to web-based learning in light of the COVID-19 pandemic, no studies to date have explored web-based learning in the specific context of NPT. Objective: This qualitative study examined the nature of interactions among peer learners (PLs), peer teachers (PTs), and the learning content in a student-led, web-based NPT program for medical students. Methods: A 5-month-long voluntary NPT program to support first- and second-year medical students’ biomedical science learning in the undergraduate medical curriculum was designed by 2 senior-year medical students and delivered by 25 PTs with 84 PLs participating. In total, 9 PLs and 3 PTs underwent individual semistructured interviews at the end of the program to explore general NPT experience, reasons for joining NPT, the effectiveness of NPT, the demand and importance of NPT, and the feasibility of incorporating NPT in the formal curriculum. Interview transcripts were analyzed using a thematic analysis approach. Results: The first general theme focused on the nature of student-student, student-teacher, and student-content interactions. Although PLs were engaged in web-based NPT, there was minimal interaction between students, as most PLs preferred to learn passively and remain anonymous. PLs believed the web-based NPT learning process to be a unidirectional transmission of knowledge from teacher to learner, with the teacher responsible for driving the interactions. This was in sharp contrast to PTs’ expectation that both parties shared responsibility for learning in a collaborative effort. The second general theme identified the advantages and disadvantages of delivering NPT on a web platform, which were mainly convenience and teaching skills development and poor interactivity, respectively. Conclusions: Student-led, web-based NPT offers a flexible and comfortable means of delivering academic and nonacademic guidance to medical students. However, the web-based mode of delivery presents unique challenges in facilitating meaningful interactions among PLs, PTs, and subject content. A blended learning approach may be best suited for this form of student-led NPT program to optimize its efficacy. %M 37184931 %R 10.2196/40716 %U https://mededu.jmir.org/2023/1/e40716 %U https://doi.org/10.2196/40716 %U http://www.ncbi.nlm.nih.gov/pubmed/37184931 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43597 %T Development of a Supported Self-management Intervention for People With Severe Mental Illness and Type 2 Diabetes: Theory and Evidence-Based Co-design Approach %A Carswell,Claire %A Coventry,Peter A %A Brown,Jennifer V E %A Alderson,Sarah L %A Double,Keith %A Gilbody,Simon %A Holt,Richard I G %A Jacobs,Rowena %A Lister,Jennie %A Osborn,David %A Shiers,David %A Siddiqi,Najma %A Taylor,Johanna %A Kellar,Ian %A , %+ Department of Health Sciences, University of York, Alcuin Research Resource Centre, Alcuin Way, Heslington Ln, Heslington, York, YO10 5DD, United Kingdom, 44 7384 239 049, claire.carswell@york.ac.uk %K severe mental illness %K diabetes %K intervention development %K co-design %K mental health %K comorbidity %K mobile phone %D 2023 %7 12.5.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Type 2 diabetes is 2 to 3 times more common among people with severe mental illness (SMI). Self-management is crucial, with additional challenges faced by people with SMI. Therefore, it is essential that any diabetes self-management program for people with SMI addresses the unique needs of people living with both conditions and the inequalities they experience within health care services. Objective: We combined theory, empirical evidence, and co-design approaches to develop a type 2 diabetes self-management intervention for people with SMI. Methods: The development process encompassed 4 steps: step 1 involved prioritizing the mechanisms of action (MoAs) and behavior change techniques (BCTs) for the intervention. Using findings from primary qualitative research and systematic reviews, we selected candidate MoAs to target in the intervention and candidate BCTs to use. Expert stakeholders then ranked these MoAs and BCTs using a 2-phase survey. The average scores were used to generate a prioritized list of MoAs and BCTs. During step 2, we presented the survey results to an expert consensus workshop to seek expert agreement with the definitive list of MoAs and BCTs for the intervention and identify potential modes of delivery. Step 3 involved the development of trigger films using the evidence from steps 1 and 2. We used animations to present the experiences of people with SMI managing diabetes. These films were used in step 4, where we used a stakeholder co-design approach. This involved a series of structured workshops, where the co-design activities were informed by theory and evidence. Results: Upon the completion of the 4-step process, we developed the DIAMONDS (diabetes and mental illness, improving outcomes and self-management) intervention. It is a tailored self-management intervention based on the synthesis of the outputs from the co-design process. The intervention incorporates a digital app, a paper-based workbook, and one-to-one coaching designed to meet the needs of people with SMI and coexisting type 2 diabetes. Conclusions: The intervention development work was underpinned by the MoA theoretical framework and incorporated systematic reviews, primary qualitative research, expert stakeholder surveys, and evidence generated during co-design workshops. The intervention will now be tested for feasibility before undergoing a definitive evaluation in a pragmatic randomized controlled trial. %M 37171868 %R 10.2196/43597 %U https://www.jmir.org/2023/1/e43597 %U https://doi.org/10.2196/43597 %U http://www.ncbi.nlm.nih.gov/pubmed/37171868 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e38552 %T Clinical Assessment of Eye Movement Desensitization and Reprocessing in Memory Distress: Protocol for a Double-Blinded Randomized Controlled Trial %A Babaei,Nazanin %A Kerry,Camrie %A Goode,Kisha %A Dang,Kevin %A Mirzadeh,Parsa %A Pirbaglou,Meysam %A Kirk,Megan A %A Ritvo,Paul %+ School of Kinesiology and Health Science, York University, 4700 Keele St,, Toronto, ON, M3J1P3, Canada, 1 416 580 8021, pritvo@yorku.ca %K EMDR variants %K eye movement desensitization reprocessing %K flash technique-EMDR %K posttraumatic stress disorder %D 2023 %7 12.5.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Exposures to “traumatic” events are widespread and can cause posttraumatic stress disorder (PTSD). Cognitive behavioral therapy and eye movement desensitization and reprocessing (EMDR) are frequently used and validated behavioral PTSD treatments. Despite demonstrated effectiveness, highly upsetting memory reactions can be evoked, resulting in extensive distress and, sometimes, treatment dropout. In recent years, multiple treatment approaches have aimed at reducing such upsetting memory reactions to traumatic memories while therapeutic progress proceeds. One of these methods, the flash technique (FT), a modification of standard EMDR (S-EMDR), appears effective in distressing memory reduction. This study will examine FT-EMDR and S-EMDR efficacies when both methods are delivered via web-based video. Objective: This study aims to assess the relative efficacy of (web-based) FT-EMDR versus S-EMDR in reducing the PTSD symptoms, anxieties, and depression associated with traumatic memories at postintervention and 1-month follow-up. Methods: This double-blinded, web-based, 2-arm randomized controlled trial will employ self-report outcomes. A total of 90 participants will be identified from the web-based CloudResearch platform and randomly allocated to the experimental or comparison group. Inclusion criteria are as follows: (1) approved for engagement by the CloudResearch platform; (2) 25-60 years of age; (3) residing in Canada or the United States; (4) a recalled disturbing memory of an event >2 years ago that has not repeated and was moderately or more upsetting during occurrence; (5) memory moderately or more upsetting at baseline and not linked to an earlier memory that is equally or more than equally disturbing. Exclusion criteria are bipolar disorder, borderline personality disorder, obsessive-compulsive disorder, schizophrenia, substance abuse or addiction in the past 3 months, suicidal ideation, and suicide attempt in the past 6 months. Interventions include guided video instruction of full FT or guided video of EMDR. Outcome measures are as follows: Primary outcome is PTSD symptoms that are measured by the PTSD Checklist for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) at 1-month follow-up. Secondary outcomes are State Anxiety subscale of State-Trait Anxiety Inventory at baseline, postintervention, and 1-month follow-up; Trait Anxiety subscale of State-Trait Anxiety Inventory; depression (Patient Health Questionnaire-9); and Positive and Negative Affect Schedule measured at 1-month follow-up. Results: If, at 1-month follow-up, the web-based FT-EMDR intervention is more effective in reducing PTSD symptoms (as measured by the PTSD Checklist for DSM-5) than EMDR, it may help reduce traumatic memory distress in multiple contexts. Conclusions: This randomized controlled trial will advance current understandings of PTSD symptoms and interventions that target traumatic memory–related distress. Trial Registration: ClinicalTrials.gov NCT05262127; https://clinicaltrials.gov/ct2/show/NCT05262127 %M 37171869 %R 10.2196/38552 %U https://www.researchprotocols.org/2023/1/e38552 %U https://doi.org/10.2196/38552 %U http://www.ncbi.nlm.nih.gov/pubmed/37171869 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 8 %N %P e44295 %T Psychological Support Strategies for Adults With Type 2 Diabetes in a Very Low–Carbohydrate Web-Based Program: Randomized Controlled Trial %A Saslow,Laura R %A Missel,Amanda L %A O’Brien,Alison %A Kim,Sarah %A Hecht,Frederick M %A Moskowitz,Judith T %A Bayandorian,Hovig %A Pietrucha,Martha %A Raymond,Kate %A Richards,Blair %A Liestenfeltz,Bradley %A Mason,Ashley E %A Daubenmier,Jennifer %A Aikens,James E %+ Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Room 2178 400NIB, Ann Arbor, MI, 48109, United States, 1 (734) 764 7836, saslowl@umich.edu %K eHealth %K type 2 diabetes %K T2D %K very low–carbohydrate diet %K weight loss %K glycemic control %K text messages %K self-monitoring %D 2023 %7 11.5.2023 %9 Original Paper %J JMIR Diabetes %G English %X Background: A very low–carbohydrate (VLC) nutritional strategy may improve glycemic control and weight loss in adults with type 2 diabetes (T2D). However, the supplementary behavioral strategies that might be able to improve outcomes using this nutritional strategy are uncertain. Objective: This study aims to compare the impact of adding 3 different supplementary behavioral strategies to a web-based VLC diet intervention. To our knowledge, this is the first trial to randomize participants to different frequencies of dietary self-monitoring. Methods: The study included 112 overweight adults with T2D (hemoglobin A1c ≥6.5%) taking no antiglycemic medications or only metformin. They received a remotely delivered 12-month VLC diet intervention. Participants were randomly assigned through a full factorial 2×2×2 design to supplementary strategies: either daily or monthly dietary self-monitoring, either mindful eating training or not, and either positive affect skills training or not. Our research goal was to determine whether 3 different supplemental strategies had at least a medium effect size (Cohen d=0.5). Results: Overall, the VLC intervention led to statistically significant improvements in glycemic control (−0.70%, 95% CI −1.04% to −0.35%; P<.001), weight loss (−6.82%, 95% CI −8.57% to −5.08%; P<.001), and depressive symptom severity (Cohen d −0.67, 95% CI −0.92 to −0.41; P<.001). Furthermore, 30% (25/83) of the participants taking metformin at baseline reduced or discontinued their metformin. Only 1 Cohen d point estimate reached 0.5; daily (vs monthly) dietary self-monitoring had a worse impact on depressive symptoms severity (Cohen d=0.47, 95% CI −0.02 to 0.95; P=.06). None of the strategies had a statistically significant effect on outcomes. For changes in our primary outcome, hemoglobin A1c, the daily (vs monthly) dietary self-monitoring impact was 0.42% (95% CI −0.28% to 1.12%); for mindful eating, it was −0.47% (95% CI −1.15% to 0.22%); and for positive affect, it was 0.12% (95% CI −0.57% to 0.82%). Other results for daily (vs monthly) dietary self-monitoring were mixed, suggesting an increase in weight (0.98%) and depressive symptoms (Cohen d=0.47), less intervention satisfaction (Cohen d=−0.20), more sessions viewed (3.02), and greater dietary adherence (Cohen d=0.24). For mindful eating, the results suggested a benefit for dietary adherence (Cohen d=0.24) and intervention satisfaction (Cohen d=0.30). For positive affect, the results suggested a benefit for depressive symptoms (Cohen d=−0.32), the number of sessions viewed (3.68), dietary adherence (Cohen d=0.16), and intervention satisfaction (Cohen d=0.25). Conclusions: Overall, our results support the use of a VLC diet intervention in adults with T2D. The addition of monthly (not daily) dietary self-monitoring, mindful eating, and positive affect skills training did not show a definitive benefit, but it is worth further testing. Trial Registration: ClinicalTrials.gov NCT03037528; https://clinicaltrials.gov/ct2/show/NCT03037528 %M 37166961 %R 10.2196/44295 %U https://diabetes.jmir.org/2023/1/e44295 %U https://doi.org/10.2196/44295 %U http://www.ncbi.nlm.nih.gov/pubmed/37166961 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e36815 %T An Evidence-Based Digital Prevention Program to Improve Oral Health Literacy of People With a Migration Background: Intervention Mapping Approach %A Weil,Marie-Theres %A Spinler,Kristin %A Lieske,Berit %A Dingoyan,Demet %A Walther,Carolin %A Heydecke,Guido %A Kofahl,Christopher %A Aarabi,Ghazal %+ Department of Periodontics, Preventive and Restorative Dentistry, Center for Dental and Oral Medicine, University Medical Center Hamburg-Eppendorf, Bldg O58, Martinistrasse 52, Hamburg, 20246, Germany, 49 40 7410 55332, g.aarabi@uke.de %K oral health %K health behavior %K oral health knowledge %K migration %K mobile health %K mHealth %K preventive dentistry %K intervention mapping %K mobile phone %D 2023 %7 11.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Studies in Germany have shown that susceptible groups, such as people with a migration background, have poorer oral health than the majority of the population. Limited oral health literacy (OHL) appears to be an important factor that affects the oral health of these groups. To increase OHL and to promote prevention-oriented oral health behavior, we developed an evidence-based prevention program in the form of an app for smartphones or tablets, the Förderung der Mundgesundheitskompetenz und Mundgesundheit von Menschen mit Migrationshintergrund (MuMi) app. Objective: This study aims to describe the development process of the MuMi app. Methods: For the description and analysis of the systematic development process of the MuMi app, we used the intervention mapping approach. The approach was implemented in 6 steps: needs assessment, formulation of intervention goals, selection of evidence-based methods and practical strategies for behavior change, planning and designing the intervention, planning the implementation and delivery of the intervention, and planning the evaluation. Results: On the basis of our literature search, expert interviews, and a focus group with the target population, we identified limited knowledge of behavioral risk factors or proper oral hygiene procedures, limited proficiency of the German language, and differing health care socialization as the main barriers to good oral health. Afterward, we selected modifiable determinants of oral health behavior that were in line with behavior change theories. On this basis, performance objectives and change objectives for the relevant population at risk were formalized. Appropriate behavior change techniques to achieve the program objectives, such as the provision of health information, encouragement of self-control and self-monitoring, and sending reminders, were identified. Subsequently, these were translated into practical strategies, such as multiple-choice quizzes or videos. The resulting program, the MuMi app, is available in the Apple app store and Android app store. The effectiveness of the app was evaluated in the MuMi intervention study. The analyses showed that users of the MuMi app had a substantial increase in their OHL and improved oral hygiene (as measured by clinical parameters) after 6 months compared with the control group. Conclusions: The intervention mapping approach provided a transparent, structured, and evidence-based process for the development of our prevention program. It allowed us to identify the most appropriate and effective techniques to initiate behavior change in the target population. The MuMi app takes into account the cultural and specific determinants of people with a migration background in Germany. To our knowledge, it is the first evidence-based app that addresses OHL among people with a migration background. %M 37166956 %R 10.2196/36815 %U https://formative.jmir.org/2023/1/e36815 %U https://doi.org/10.2196/36815 %U http://www.ncbi.nlm.nih.gov/pubmed/37166956 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e43645 %T An Intervention to Increase Condom Use Among Users of Sexually Transmitted Infection Self-sampling Websites (Wrapped): Protocol for a Randomized Controlled Feasibility Trial %A Newby,Katie %A Kwah,Kayleigh %A Schumacher,Lauren %A Crutzen,Rik %A Bailey,Julia V %A Jackson,Louise J %A Bremner,Stephen %A Brown,Katherine E %+ Department of Psychology, Sport and Geography, School of Life and Medical Sciences, University of Hertfordshire, Room 1H273, CP Snow Building, School of Life and Medical Sciences, Hatfield, AL10 9AB, United Kingdom, 44 7842600795, k.newby@herts.ac.uk %K adolescent %K condom use %K digital health %K eHealth %K feasibility randomized controlled trial %K sexual health %K sexually transmitted infections %K STIs %K self-testing %K young people %D 2023 %7 11.5.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Reducing the rates of sexually transmitted infections (STIs) among young people is a public health priority. The best way to avoid STIs from penetrative sex is to use a condom, but young people report inconsistent use. A missed opportunity to intervene to increase condom use is when young people access self-sampling kits for STIs through the internet. The potential of this opportunity is enhanced by the increasing numbers of young people being tested through this route every year in England. Hence, in a cocreation by young people, stakeholders, and researchers, Wrapped was developed––a fully automated, multicomponent, and interactive digital behavior change intervention developed for users of STI self-sampling websites, who are aged 16-24 years. Objective: This paper is a protocol for a feasibility randomized controlled trial (fRCT). The fRCT seeks to establish whether it is feasible to run a randomized controlled trial to test the effectiveness and cost-effectiveness of Wrapped. Wrapped aims to reduce the incidence of STIs through increasing correct and consistent use of condoms among users of STI self-sampling websites, who are aged 16-24 years. Methods: A 2-arm parallel-group randomized fRCT of Wrapped plus usual care, compared to usual care only (basic information on STIs and condom use), with a nested qualitative study. A minimum of 230 participants (aged 16-24 years) are recruited from an existing chlamydia self-sampling website. Participants are randomized into 1 of 2 parallel groups (1:1 allocation). Primary outcomes are the percentage of users recruited to the fRCT and the percentage of randomized participants who return a chlamydia self-sampling kit at month 12. Additionally, besides chlamydia positivity based on biological samples, surveys at baseline, month 3, month 6, and month 12, are used to assess condom use attitude, behavioral capability, self-efficacy, and intention, along with details of any partnered sexual activity and condom use, and health economic data. Nested qualitative interviews with trial participants are used to gain insight into the factors affecting recruitment and attrition. Results: Recruitment to the fRCT began in March 2021 and was completed in October 2021. Data collection was completed in December 2022. Conclusions: This feasibility study will provide data to inform the design of a future-definitive trial. This work is timely given a rapid rise in the use of internet testing for STIs and the sustained high levels of STIs among young people. Trial Registration: ISRCTN Registry ISRCTN17478654; http://www.isrctn.com/ISRCTN17478654 International Registered Report Identifier (IRRID): DERR1-10.2196/43645 %M 37166958 %R 10.2196/43645 %U https://www.researchprotocols.org/2023/1/e43645 %U https://doi.org/10.2196/43645 %U http://www.ncbi.nlm.nih.gov/pubmed/37166958 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43669 %T Effectiveness of an Immersive Telemedicine Platform for Delivering Diabetes Medical Group Visits for African American, Black and Hispanic, or Latina Women With Uncontrolled Diabetes: The Women in Control 2.0 Noninferiority Randomized Clinical Trial %A Mitchell,Suzanne E %A Bragg,Alexa %A De La Cruz,Barbara A %A Winter,Michael R %A Reichert,Matthew J %A Laird,Lance D %A Moldovan,Ioana A %A Parker,Kimberly N %A Martin-Howard,Jessica %A Gardiner,Paula %+ Department of Family Medicine and Community Health, University of Massachusetts Chan Medical School, 55 Lake Avenue North, Worcester, MA, 01655, United States, 1 9789856033, suzanne.mitchell2@umassmed.edu %K type 2 diabetes mellitus %K virtual world %K women %K digital health %K diabetes self-management education %K self-management %K health equity %K Hispanic or Latina %K Black or African American %K group visit %K shared medical appointment %D 2023 %7 10.5.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Medically underserved people with type 2 diabetes mellitus face limited access to group-based diabetes care, placing them at risk for poor disease control and complications. Immersive technology and telemedicine solutions could bridge this gap. Objective: The purpose of this study was to compare the effectiveness of diabetes medical group visits (DMGVs) delivered in an immersive telemedicine platform versus an in-person (IP) setting and establish the noninferiority of the technology-enabled approach for changes in hemoglobin A1c (HbA1c) and physical activity (measured in metabolic equivalent of task [MET]) at 6 months. Methods: This study is a noninferiority randomized controlled trial conducted from February 2017 to December 2019 at an urban safety net health system and community health center. We enrolled adult women (aged ≥18 years) who self-reported African American or Black race or Hispanic or Latina ethnicity and had type 2 diabetes mellitus and HbA1c ≥8%. Participants attended 8 weekly DMGVs, which included diabetes self-management education, peer support, and clinician counseling using a culturally adapted curriculum in English or Spanish. In-person participants convened in clinical settings, while virtual world (VW) participants met remotely via an avatar-driven, 3D VW linked to video teleconferencing. Follow-up occurred 6 months post enrollment. Primary outcomes were mean changes in HbA1c and physical activity at 6 months, with noninferiority margins of 0.7% and 12 MET-hours, respectively. Secondary outcomes included changes in diabetes distress and depressive symptoms. Results: Of 309 female participants (mean age 55, SD 10.6 years; n=195, 63% African American or Black; n=105, 34% Hispanic or Latina; n=151 IP; and n=158 in VW), 207 (67%) met per-protocol criteria. In the intention-to-treat analysis, we confirmed noninferiority for primary outcomes. We found similar improvements in mean HbA1c by group at 6 months (IP: –0.8%, SD 1.9%; VW: –0.5%, SD 1.8%; mean difference 0.3, 97.5% CI –∞ to 0.3; P<.001). However, there were no detectable improvements in physical activity (IP: –6.5, SD 43.6; VW: –9.6, SD 44.8 MET-hours; mean difference –3.1, 97.5% CI –6.9 to ∞; P=.02). The proportion of participants with significant diabetes distress and depressive symptoms at 6 months decreased in both groups. Conclusions: In this noninferiority randomized controlled trial, immersive telemedicine was a noninferior platform for delivering diabetes care, eliciting comparable glycemic control improvement, and enhancing patient engagement, compared to IP DMGVs. Trial Registration: ClinicalTrials.gov NCT02726425; https://clinicaltrials.gov/ct2/show/NCT02726425 %M 37163341 %R 10.2196/43669 %U https://www.jmir.org/2023/1/e43669 %U https://doi.org/10.2196/43669 %U http://www.ncbi.nlm.nih.gov/pubmed/37163341 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45802 %T Comparing Implementation Strategies for an Evidence-Based Weight Management Program Delivered in Community Mental Health Programs: Protocol for a Pilot Randomized Controlled Trial %A Jerome,Gerald J %A Goldsholl,Stacy %A Dalcin,Arlene T %A Gennusa 3rd,Joseph V %A Yuan,Christina T %A Brown,Kristal %A Fink,Tyler %A Minahan,Eva %A Wang,Nae-Yuh %A Daumit,Gail L %A Gudzune,Kimberly %+ Department of Medicine, Johns Hopkins University School of Medicine, 2024 E Monument St, Room 2-621, Baltimore, MD, 21287, United States, 1 4432877238, gudzune@jhu.edu %K community mental health services %K weight reduction programs %K mental disorders %K implementation science %K mental health %K randomized controlled trial %K obesity %K behavioral intervention %K weight loss %K strategy %K community %K weight %K body mass index %K BMI %K obesity %K mental illness %K mental health %K cardiovascular disease %K psychiatric rehabilitation %K RCT %K coach %K electronic coach %D 2023 %7 10.5.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Among people with serious mental illness (SMI), obesity contributes to increased cardiovascular disease (CVD) risk. The Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE) randomized controlled trial (RCT) demonstrated that a behavioral intervention tailored to the needs of individuals with SMI results in clinically significant weight loss. While the research team delivered the ACHIEVE intervention in the trial, community mental health program staff are needed to deliver sessions to make scale-up feasible. Therefore, we adapted the ACHIEVE-Dissemination (ACHIEVE-D) curriculum to ease adoption and implementation in this setting. Designing and testing of implementation strategies is now needed to understand how to support ACHIEVE-D delivery by community mental health program staff coaches. Objective: This study aims to conduct a pilot trial evaluating standard and enhanced implementation interventions to support the delivery of ACHIEVE-D in community mental health programs by examining effects on staff coaches’ knowledge, self-efficacy, and delivery fidelity of the curriculum. We will also examine the effects on outcomes among individuals with SMI taking part in the curriculum. Methods: The trial will be a cluster-randomized, 2-arm parallel pilot RCT comparing standard and enhanced implementation intervention at 6 months within community mental health programs. We will randomly assign programs to either the standard or enhanced implementation interventions. The standard intervention will combine multimodal training for coaches (real-time initial training via videoconference, ongoing virtual training, and web-based avatar-assisted motivational interviewing practice) with organizational strategy meetings to garner leadership support for implementation. The enhanced intervention will include all standard strategies, and the coaches will receive performance coaching. At each program, we will enroll staff to participate as coaches and clients with SMI to participate in the curriculum. Coaches will deliver the ACHIEVE-D curriculum to the clients with SMI. Primary outcomes will be coaches’ knowledge, self-efficacy, and fidelity to the ACHIEVE-D curriculum. We will also examine the acceptability, feasibility, and appropriateness of ACHIEVE-D and the implementation strategies. Secondary outcomes among individuals with SMI will be weight and self-reported lifestyle behaviors. Results: Data collection started in March 2021, with completion estimated in March 2023. We recruited 9 sites and a total of 20 staff coaches and 72 clients with SMI. The expected start of data analyses will occur in March 2023, with primary results submitted for publication in April 2023. Conclusions: Community mental health programs may be an ideal setting for implementing an evidence-based weight management curriculum for individuals with SMI. This pilot study will contribute knowledge about implementation strategies to support the community-based delivery of such programs, which may inform future research that definitively tests the implementation and dissemination of behavioral weight management programs. Trial Registration: ClinicalTrials.gov NCT03454997; https://clinicaltrials.gov/ct2/show/NCT03454997 International Registered Report Identifier (IRRID): DERR1-10.2196/45802 %M 37163331 %R 10.2196/45802 %U https://www.researchprotocols.org/2023/1/e45802 %U https://doi.org/10.2196/45802 %U http://www.ncbi.nlm.nih.gov/pubmed/37163331 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42111 %T Expanding the Evidence on the Safety and Efficiency of 2-Way Text Messaging–Based Telehealth for Voluntary Medical Male Circumcision Follow-up Compared With In-Person Reviews: Randomized Controlled Trial in Rural and Urban South Africa %A Feldacker,Caryl %A Pienaar,Jacqueline %A Wasunna,Beatrice %A Ndebele,Felex %A Khumalo,Calsile %A Day,Sarah %A Tweya,Hannock %A Oni,Femi %A Sardini,Maria %A Adhikary,Binod %A Waweru,Evelyn %A Wafula,Mourice Barasa %A Dixon,Anna %A Jafa,Krishna %A Su,Yanfang %A Sherr,Kenneth %A Setswe,Geoffrey %+ Department of Global Health, University of Washington, Hans Rosling Center, 3980 15th Ave NE, Seattle, WA, 98105, United States, 1 (206) 221 4970, cfeld@uw.edu %K SMS text messaging–based telehealth %K 2-way texting %K voluntary medical male circumcision %K South Africa %K mobile health %K mHealth for quality improvement %K digital health innovation in low- and middle-income countries %K male engagement in care %K COVID-19 %K mobile phone %D 2023 %7 9.5.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: There is a dearth of high-quality evidence from digital health interventions in routine program settings in low- and middle-income countries. We previously conducted a randomized controlled trial (RCT) in Zimbabwe, demonstrating that 2-way texting (2wT) was safe and effective for follow-up after adult voluntary medical male circumcision (VMMC). Objective: To demonstrate the replicability of 2wT, we conducted a larger RCT in both urban and rural VMMC settings in South Africa to determine whether 2wT improves adverse event (AE) ascertainment and, therefore, the quality of follow-up after VMMC while reducing health care workers’ workload. Methods: A prospective, unblinded, noninferiority RCT was conducted among adult participants who underwent VMMC with cell phones randomized in a 1:1 ratio between 2wT and control (routine care) in North West and Gauteng provinces. The 2wT participants responded to a daily SMS text message with in-person follow-up only if desired or an AE was suspected. The control group was requested to make in-person visits on postoperative days 2 and 7 as per national VMMC guidelines. All participants were asked to return on postoperative day 14 for study-specific review. Safety (cumulative AEs ≤day 14 visit) and workload (number of in-person follow-up visits) were compared. Differences in cumulative AEs were calculated between groups. Noninferiority was prespecified with a margin of −0.25%. The Manning score method was used to calculate 95% CIs. Results: The study was conducted between June 7, 2021, and February 21, 2022. In total, 1084 men were enrolled (2wT: n=547, 50.5%, control: n=537, 49.5%), with near-equal proportions of rural and urban participants. Cumulative AEs were identified in 2.3% (95% CI 1.3-4.1) of 2wT participants and 1.0% (95% CI 0.4-2.3) of control participants, demonstrating noninferiority (1-sided 95% CI −0.09 to ∞). Among the 2wT participants, 11 AEs (9 moderate and 2 severe) were identified, compared with 5 AEs (all moderate) among the control participants—a nonsignificant difference in AE rates (P=.13). The 2wT participants attended 0.22 visits, and the control participants attended 1.34 visits—a significant reduction in follow-up visit workload (P<.001). The 2wT approach reduced unnecessary postoperative visits by 84.8%. Daily response rates ranged from 86% on day 3 to 74% on day 13. Among the 2wT participants, 94% (514/547) responded to ≥1 daily SMS text messages over 13 days. Conclusions: Across rural and urban contexts in South Africa, 2wT was noninferior to routine in-person visits for AE ascertainment, demonstrating 2wT safety. The 2wT approach also significantly reduced the follow-up visit workload, improving efficiency. These results strongly suggest that 2wT provides quality VMMC follow-up and should be adopted at scale. Adaptation of the 2wT telehealth approach to other acute follow-up care contexts could extend these gains beyond VMMC. Trial Registration: ClinicalTrials.gov NCT04327271; https://www.clinicaltrials.gov/ct2/show/NCT04327271 %M 37159245 %R 10.2196/42111 %U https://www.jmir.org/2023/1/e42111 %U https://doi.org/10.2196/42111 %U http://www.ncbi.nlm.nih.gov/pubmed/37159245 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43196 %T Effectiveness of a Mobile App (KhunLook) Versus the Maternal and Child Health Handbook on Thai Parents’ Health Literacy, Accuracy of Health Assessments, and Convenience of Use: Randomized Controlled Trial %A Areemit,Rosawan %A Saengnipanthkul,Suchaorn %A Sutra,Sumitr %A Lumbiganon,Pagakrong %A Pornprasitsakul,Phenphitcha %A Paopongsawan,Pongsatorn %A Sripanidkulchai,Kunwadee %+ Department of Pediatrics, Faculty of Medicine, Khon Kaen University, 123, Mittraphap Road, Muang District, Khon Kaen, 40002, Thailand, 66 885101031, suchsa@kku.ac.th %K health literacy %K mobile app %K mHealth %K KhunLook %K Maternal and Child Health Handbook %K parent %K health assessment %K child health supervision %K Thailand %D 2023 %7 9.5.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Children of parents who have higher health literacy (HL) benefit more from preventive child health care. Digital interventions have been used to improve parents’ HL with high satisfaction. KhunLook is a Thai mobile app conceived using strategies to improve HL. It was developed to assist parents in assessing and keeping track of their child’s health in complement to the standard Maternal and Child Health Handbook (MCHH). Objective: This trial focuses on the effectiveness of using the KhunLook app with the MCHH and standard care (intervention) compared with the conventional MCHH and standard care (control) on parents’ HL. Data on accuracy of parents’ assessment of their child’s health and growth as well as convenience of use of the tool (app or MCHH) in the well-child clinic were collected at 2 visits (immediate=visit 1, and intermediate=visit 2). Methods: Parents of children under 3 years of age who (1) had a smartphone or tablet and the MCHH and (2) could participate in 2 visits, 2-6 months apart at Srinagarind Hospital, Khon Kaen, Thailand, were enrolled in this 2-arm parallel randomized controlled trial between April 2020 and May 2021. Parents were randomized 1:1 to 2 groups. At visit 1, data on demographics and baseline HL (Thailand Health Literacy Scales) were collected. Parents in the app group used the KhunLook app and the control group used their child’s handbook to assess their child’s growth, development, nutrition and feeding, immunization status and rated the convenience of the tool they used. At visit 2, they repeated the assessments and completed the HL questionnaire. Results: A total of 358 parents completed the study (358/408, 87.7%). After the intervention, the number of parents with high total HL significantly increased from 94/182 (51.6%) to 109/182 (59.9%; 15/182; Δ 8.2%; P=.04), specifically in the health management (30/182; Δ 16.4%; P<.001) and child health management (18/182; Δ 9.9%; P=.01) domains in the app group, but not in the control group. Parents in the app group could correctly assess their child’s head circumference (172/182, 94.5% vs 124/176, 70.5%; P<.001) and development (173/182, 95.1% vs 139/176, 79.0%; P<.001) better than those in the control group at both visits. A higher proportion of parents in the app group rated their tool as very easy or easy to use (174-181/182, 95.6%-99.5% vs 141-166/176, 80.1%-94.3%; P<.001) on every item since the first visit. Conclusions: Our results suggest the potential of a smartphone app (KhunLook) to improve parents’ HL as well as to promote superior accuracy of parents’ assessment of their child’s head circumference and development, with a similar effect on weight, height, nutrition and feeding, and immunization as in traditional interventions. Using the KhunLook app is useful and more convenient for parents in promoting a healthy child preventive care during early childhood. Trial Registration: Thai Clinical Trials Registry TCTR20200312003; https://www.thaiclinicaltrials.org/show/TCTR20200312003 %M 37159258 %R 10.2196/43196 %U https://www.jmir.org/2023/1/e43196 %U https://doi.org/10.2196/43196 %U http://www.ncbi.nlm.nih.gov/pubmed/37159258 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 8 %N %P e44652 %T Technology-Supported Integrated Care Innovations to Support Diabetes and Mental Health Care: Scoping Review %A Racey,Megan %A Whitmore,Carly %A Alliston,Paige %A Cafazzo,Joseph A %A Crawford,Allison %A Castle,David %A Dragonetti,Rosa %A Fitzpatrick-Lewis,Donna %A Jovkovic,Milos %A Melamed,Osnat C %A Naeem,Farooq %A Senior,Peter %A Strudwick,Gillian %A Ramdass,Seeta %A Vien,Victor %A Selby,Peter %A Sherifali,Diana %+ McMaster Evidence Review and Synthesis Team, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada, 1 905 525 9140 ext 21435, dsherif@mcmaster.ca %K technology %K mental health %K type 2 diabetes %K type 1 diabetes %K virtual care %K integrated care %K scoping review %K health information technology %K digital health %K support %K psychosocial %K education %K application %K distress %K clinical integration %K intervention %D 2023 %7 9.5.2023 %9 Review %J JMIR Diabetes %G English %X Background: For individuals living with diabetes and its psychosocial comorbidities (eg, depression, anxiety, and distress), there remains limited access to interprofessional, integrated care that includes mental health support, education, and follow-up. Health technology, broadly defined as the application of organized knowledge or skill as software, devices, and systems to solve health problems and improve quality of life, is emerging as a means of addressing these gaps. There is thus a need to understand how such technologies are being used to support, educate, and help individuals living with co-occurring diabetes and mental health distress or disorder. Objective: The purpose of this scoping review was to (1) describe the literature on technology-enabled integrated interventions for diabetes and mental health; (2) apply frameworks from the Mental Health Commission of Canada and World Health Organization to elucidate the components, type, processes, and users of technology-enabled integrated interventions for diabetes and mental health; and (3) map the level of integration of interventions for diabetes and mental health. Methods: We searched 6 databases from inception to February 2022 for English-language, peer-reviewed studies of any design or type that used technology to actively support both diabetes and any mental health distress or disorder in succession or concurrently among people with diabetes (type 1 diabetes, type 2 diabetes, and gestational diabetes). Reviewers screened citations and extracted data including study characteristics and details about the technology and integration used. Results: We included 24 studies described in 38 publications. These studies were conducted in a range of settings and sites of care including both web-based and in-person settings. Studies were mostly website-based (n=13) and used technology for wellness and prevention (n=16) and intervention and treatment (n=15). The primary users of these technologies were clients and health care providers. All the included intervention studies (n=20) used technology for clinical integration, but only 7 studies also used the technology for professional integration. Conclusions: The findings of this scoping review suggest that there is a growing body of literature on integrated care for diabetes and mental health enabled by technology. However, gaps still exist with how to best equip health care professionals with the knowledge and skills to offer integrated care. Future research is needed to continue to explore the purpose, level, and breadth of technology-enabled integration to facilitate an approach to overcome or address care fragmentation for diabetes and mental health and to understand how health technology can further drive the scale-up of innovative integrated interventions. %M 37159256 %R 10.2196/44652 %U https://diabetes.jmir.org/2023/1/e44652 %U https://doi.org/10.2196/44652 %U http://www.ncbi.nlm.nih.gov/pubmed/37159256 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e43961 %T Exploring Social Media Preferences for Healthy Weight Management Interventions Among Adolescents of Color: Mixed Methods Study %A Alatorre,Selenne %A Schwarz,Aviva G %A Egan,Kelsey A %A Feldman,Amanda R %A Rosa,Marielis %A Wang,Monica L %+ Department of Community Health Sciences, Boston University School of Public Health, 801 Massachusetts Avenue, Boston, MA, 02118, United States, 1 6179106041, mlwang@bu.edu %K social media %K adolescents of color %K obesity disparities %K disparity %K disparities %K healthy weight management %K health education %K child health %K mHealth %K mobile health %K weight %K obese %K obesity %K child %K pediatric %K adolescent %K adolescence %K preference %K health behavior %K mobile phone %D 2023 %7 8.5.2023 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Social media holds promise as an intervention platform to engage youths in healthy weight management and target racial inequities in obesity. Objective: This mixed methods study aimed to examine social media habits, preferences, and obesity-related behaviors (eg, diet and physical activity) among adolescents of color and understand preferences for healthy weight management interventions delivered via social media. Methods: This mixed methods study is comprised of a cross-sectional web-based survey and a series of digital focus groups. Study participants (English-speaking youths of color ages 14-18 years) were recruited from high schools and youth-based community settings in Massachusetts and California. For surveys, participants were invited to complete an anonymous web-based survey assessing self-reported sociodemographics, social media habits and preferences, health behaviors (diet, physical activity, sleep, and screen time), and height and weight. For focus groups, participants were invited to participate in 45- to 60-minute web-based group discussions assessing social media habits, preferred social media platforms, and preferences for physical activity and nutrition intervention content and delivery. Survey data were analyzed descriptively; focus group transcripts were analyzed using a directed content analysis approach. Results: A total of 101 adolescents completed the survey and 20 adolescents participated in a total of 3 focus groups. Participants reported most frequently using TikTok, followed by Instagram, Snapchat, and Twitter; preference for platform varied by purpose of use (eg, content consumption, connection, or communication). TikTok emerged as the platform of choice as an engaging way to learn about various topics, including desired health information on physical fitness and diet. Conclusions: Findings from this study suggest that social media platforms can be an engaging way to reach adolescents of color. Data will inform future social media–based interventions to engage adolescents of color in healthy weight management content. %M 37155230 %R 10.2196/43961 %U https://pediatrics.jmir.org/2023/1/e43961 %U https://doi.org/10.2196/43961 %U http://www.ncbi.nlm.nih.gov/pubmed/37155230 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44692 %T Domesticating Social Alarm Systems in Nursing Homes: Qualitative Study of Differences in the Perspectives of Assistant Nurses %A Chang,Fangyuan %A Östlund,Britt %A Kuoppamäki,Sanna %+ Department of Design, Shanghai Jiao Tong University, Dongchuan Road 800, Shanghai, 200240, China, 86 18205195569, fangyuanchang@sjtu.edu.cn %K technology implementation %K nursing care %K social alarm system %K domestication %K nursing home %K technology integration %K long-term care %K social alarm %K nursing %K elder %K older adult %K aging %K gerontology %K geriatric %K interview %K qualitative %D 2023 %7 5.5.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: New social alarm solutions are viewed as a promising approach to alleviate the global challenge of an aging population and a shortage of care staff. However, the uptake of social alarm systems in nursing homes has proven both complex and difficult. Current studies have recognized the benefits of involving actors such as assistant nurses in advancing these implementations, but the dynamics by which implementations are created and shaped in their daily practices and relations have received less attention. Objective: Based on domestication theory, this paper aims to identify the differences in the perspectives of assistant nurses when integrating a social alarm system into daily practices. Methods: We interviewed assistant nurses (n=23) working in nursing homes to understand their perceptions and practices during the uptake of social alarm systems. Results: During the four domestication phases, assistant nurses were facing different challenges including (1) system conceptualization; (2) spatial employment of social alarm devices; (3) treatment of unexpected issues; and (4) evaluation of inconsistent competence in technology use. Our findings elaborate on how assistant nurses have distinct goals, focus on different facets, and developed diverse coping strategies to facilitate the system domestication in different phases. Conclusions: Our findings reveal a divide among assistant nurses in terms of domesticating social alarm systems and stress the potential of learning from each other to facilitate the whole process. Further studies could focus on the role of collective practices during different domestication phases to enhance the understanding of technology implementation in the contexts of complex interactions within a group. %M 37145835 %R 10.2196/44692 %U https://www.jmir.org/2023/1/e44692 %U https://doi.org/10.2196/44692 %U http://www.ncbi.nlm.nih.gov/pubmed/37145835 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45136 %T Preliminary Evaluation of Translated and Culturally Adapted Internet-Delivered Cognitive Therapy for Social Anxiety Disorder: Multicenter, Single-Arm Trial in Japan %A Yoshinaga,Naoki %A Thew,Graham R %A Hayashi,Yuta %A Matsuoka,Jun %A Tanoue,Hiroki %A Takanashi,Rieko %A Araki,Mutsumi %A Kanai,Yoshihiro %A Smith,Alisha %A Grant,Sophie H L %A Clark,David M %+ School of Nursing, Faculty of Medicine, University of Miyazaki, 5200 Kihara, Kiyotake, Miyazaki, 889-1692, Japan, 81 985 85 9784, naoki-y@med.miyazaki-u.ac.jp %K benchmarking %K anxiety %K social anxiety %K social phobia %K cognitive behavioral therapy %K cognitive therapy %K cross-cultural comparison %K Japan %K mental disorders %K internet-based intervention %K mobile phone %D 2023 %7 5.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Internet-delivered cognitive therapy for social anxiety disorder (iCT-SAD), which is a therapist-guided modular web-based treatment, has shown strong efficacy and acceptability in English-language randomized controlled trials in the United Kingdom and Hong Kong. However, it is not yet known whether iCT-SAD can retain its efficacy following linguistic translation and cultural adaptation of treatment contents and implementation in other countries such as Japan. Objective: This study aimed to examine the preliminary efficacy and acceptability of the translated and culturally adapted iCT-SAD in Japanese clinical settings. Methods: This multicenter, single-arm trial recruited 15 participants with social anxiety disorder. At the time of recruitment, participants were receiving usual psychiatric care but had not shown improvement in their social anxiety and required additional treatment. iCT-SAD was provided in combination with usual psychiatric care for 14 weeks (treatment phase) and for a subsequent 3-month follow-up phase that included up to 3 booster sessions. The primary outcome measure was the self-report version of the Liebowitz Social Anxiety Scale. The secondary outcome measures examined social anxiety–related psychological processes, taijin kyofusho (the fear of offending others), depression, generalized anxiety, and general functioning. The assessment points for the outcome measures were baseline (week 0), midtreatment (week 8), posttreatment (week 15; primary assessment point), and follow-up (week 26). Acceptability was measured using the dropout rate from the treatment, the level of engagement with the program (the rate of module completion), and participants’ feedback about their experience with the iCT-SAD. Results: Evaluation of the outcome measures data showed that iCT-SAD led to significant improvements in social anxiety symptoms during the treatment phase (P<.001; Cohen d=3.66), and these improvements were maintained during the follow-up phase. Similar results were observed for the secondary outcome measures. At the end of the treatment phase, 80% (12/15) of participants demonstrated reliable improvement, and 60% (9/15) of participants demonstrated remission from social anxiety. Moreover, 7% (1/15) of participants dropped out during treatment, and 7% (1/15) of participants declined to undergo the follow-up phase after completing the treatment. No serious adverse events occurred. On average, participants completed 94% of the modules released to them. Participant feedback was positive and highlighted areas of strength in treatment, and it included further suggestions to improve suitability for Japanese settings. Conclusions: Translated and culturally adapted iCT-SAD demonstrated promising initial efficacy and acceptability for Japanese clients with social anxiety disorder. A randomized controlled trial is required to examine this more robustly. %M 37145850 %R 10.2196/45136 %U https://formative.jmir.org/2023/1/e45136 %U https://doi.org/10.2196/45136 %U http://www.ncbi.nlm.nih.gov/pubmed/37145850 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e37727 %T A Mobile Self-control Training App to Improve Self-control and Physical Activity in People With Severe Mental Illness: Protocol for 2 Single-Case Experimental Designs %A Dekkers,Tessa %A Heirbaut,Tahnee %A Schouten,Stephanie E %A Kelders,Saskia M %A Beerlage-de Jong,Nienke %A Ludden,Geke D S %A Deenik,Jeroen %A Bouman,Yvonne H A %A Kip,Hanneke %+ Centre for eHealth and Wellbeing Research, Department of Technology, Human and Institutional Behaviour, University of Twente, Drienerlolaan 5, Enschede, 7522 NB, Netherlands, 31 534896536, t.dekkers@utwente.nl %K mobile health %K mHealth %K mobile apps %K self-control %K physical activity %K accelerometry %K single-case experimental design %K mobile phone %D 2023 %7 5.5.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Lack of physical activity is a common issue with detrimental consequences for the health of people with severe mental illness (SMI). Existing physical activity interventions show suboptimal effects as they require substantial cognitive skills, including goal setting and writing, whereas cognitive deficits are common in this population. To bolster the effectiveness of physical activity interventions, self-control training (SCT), in which users practice the ability to override unwanted thoughts and behaviors, can be used in addition. Recent research has demonstrated the initial effectiveness of a mobile SCT app, but this has not been studied in psychiatric clinical practice. Objective: This study aims to evaluate to what extent adding a mobile SCT app designed for and with people with SMI to a mobile lifestyle intervention aimed at increasing physical activity increases physical activity and self-control levels. Methods: A mixed methods approach incorporating 2 single-case experimental designs (SCEDs) and qualitative interviews was used to evaluate and optimize SCT. Overall, 12 participants with SMI will be recruited from 2 organizations offering outpatient and inpatient care to people with SMI. Each experiment will include 6 patients. SCED I is a concurrent multiple-baseline design across participants that explores initial effectiveness and optimal intervention duration. Using accelerometry and experience sampling questionnaires, participants’ physical activity and self-control will be monitored for ≥5 days from baseline, followed by the sequential introduction of Google Fit, the physical activity intervention, for 7 days and the addition of SCIPP: Self-Control Intervention App for 28 days. SCED II is an introduction/withdrawal design in which optimized SCT will be introduced and withdrawn to validate the findings from SCED I. In both experiments, the daily average of total activity counts per hour and the state level of self-control will serve as the primary and secondary outcome measures. Data will be analyzed using visual analysis and piecewise linear regression models. Results: The study was designated as not subject to the Dutch Medical Research Involving Human Subjects Act by the Medical Research Ethical Committee Oost-Nederland and approved by the Ethics Committee/domain Humanities and Social Sciences of the Faculty of Behavioural, Management, and Social Sciences at the University of Twente. Participant recruitment started in January 2022, and we expect to publish the results in early 2023. Conclusions: The mobile SCT app is expected to be feasible and effective. It is self-paced and scalable and can increase patient motivation, making it a suitable intervention for people with SMI. SCED is a relatively novel yet promising method for gaining insights into whether and how mobile apps work that can handle heterogeneous samples and makes it possible to involve a diverse population with SMI without having to include a large number of participants. International Registered Report Identifier (IRRID): PRR1-10.2196/37727 %M 37145845 %R 10.2196/37727 %U https://www.researchprotocols.org/2023/1/e37727 %U https://doi.org/10.2196/37727 %U http://www.ncbi.nlm.nih.gov/pubmed/37145845 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e40914 %T Using Animated Videos to Promote the Accessibility and Understandability of Package Leaflets: Retrospective Observational Study Evaluating the First Year of Implementation %A van den Berg,Liselot N %A Chavannes,Niels H %A Aardoom,Jiska J %+ Department of Public Health and Primary Care, Leiden University Medical Center, Hippocratespad 21, Leiden, 2300 RC, Netherlands, 31 71 526 57 61, L.N.van_den_Berg@lumc.nl %K package leaflet %K health literacy %K implementation %K online library %K animated videos %K accessibility %K understandability %K comprehension %K eHealth %K medication %K health communication %D 2023 %7 4.5.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: The medication package leaflet is the most used and trusted source of information in the home situation but is often incomprehensible for individuals, especially for those with limited health literacy. The platform “Watchyourmeds” comprises a web-based library with over 10,000 animated videos that explain the most essential information from the package leaflet in an unambiguous and simple manner to increase the accessibility and understandability of package leaflets. Objective: This study aimed to investigate Watchyourmeds in the Netherlands from a user perspective during the first year of implementation by investigating (1) usage data, (2) self-reported user experiences, and (3) the preliminary and potential impact on medication knowledge. Methods: This was a retrospective observational study. The first aim was investigated by examining objective user data from 1815 pharmacies from the first year of implementation of Watchyourmeds. User experiences (second aim) were investigated by examining individuals’ completed self-report questionnaires (n=4926) that they received after completing a video. The preliminary and potential impact on medication knowledge (third aim) was investigated by examining users’ self-report questionnaire data (n=67) that assessed their medication knowledge about their prescribed medication. Results: Nearly 1.8 million videos have been distributed to users by over 1400 pharmacies, with monthly numbers increasing to 280,000 in the last month of the implementation year. Most users (4444/4805, 92.5%) indicated to have fully understood the information presented in the videos. Female users reported more often to have fully understood the information than male users (χ24=11.5, P=.02). Most users (3662/4805, 76.2%) said that they did not think any information was missing in the video. Users with a lower educational level stated more often (1104/1290, 85.6%) than those with a middle (984/1230, 80%) or higher (964/1229, 78.4%) educational level that they did not seem to be missing any information in the videos (χ212=70.6, P<.001). A total of 84% (4142/4926) of the users stated that they would like to use Watchyourmeds more often and for all their medication, or would like to use it most of the time. Male users and older users stated more often that they would use Watchyourmeds again for other medication than the female (χ23=25.0, P<.001) and younger users (χ23=38.1, P<.001), respectively. Almost 88% (4318/4926) of the users would recommend the web-based library to friends, family, or acquaintances. Regarding the third aim, results showed that 73.8% (293/397) of the questions assessing users’ medication knowledge were answered correctly. Conclusions: The results of this study suggest that a web-based library with animated videos is a valuable and acceptable addition to stand-alone package leaflets to increase the understanding and accessibility of medication information. %M 37140968 %R 10.2196/40914 %U https://www.jmir.org/2023/1/e40914 %U https://doi.org/10.2196/40914 %U http://www.ncbi.nlm.nih.gov/pubmed/37140968 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e40955 %T Stop and Play Digital Health Education Intervention for Reducing Excessive Screen Time Among Preschoolers From Low Socioeconomic Families: Cluster Randomized Controlled Trial %A Raj,Diana %A Ahmad,Norliza %A Mohd Zulkefli,Nor Afiah %A Lim,Poh Ying %+ Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Jalan Hospital Serdang, Serdang, 43400, Malaysia, 60 397692582, lizaahmad@upm.edu.my %K child %K preschool %K screen time %K mother-child %K randomized controlled trial %K mobile phone %D 2023 %7 4.5.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: High prevalence of excessive screen time among preschool children is attributable to certain parental factors such as lack of knowledge, false perception about screen time, and inadequate skills. Lack of strategies to implement screen time guidelines, in addition to multiple commitments that may hinder parents from face-to-face interventions, demands the need to develop a technology-based parent-friendly screen time reduction intervention. Objective: This study aims to develop, implement, and evaluate the effectiveness of Stop and Play, a digital parental health education intervention to reduce excessive screen time among preschoolers from low socioeconomic families in Malaysia. Methods: A single-blind, 2-arm cluster randomized controlled trial was conducted among 360 mother-child dyads attending government preschools in the Petaling district, who were randomly allocated into the intervention and waitlist control groups between March 2021 and December 2021. This 4-week intervention, developed using whiteboard animation videos, infographics, and a problem-solving session, was delivered via WhatsApp (WhatsApp Inc). Primary outcome was the child’s screen time, whereas secondary outcomes included mother’s screen time knowledge, perception about the influence of screen time on the child’s well-being, self-efficacy to reduce the child’s screen time and increase physical activity, mother’s screen time, and presence of screen device in the child’s bedroom. Validated self-administered questionnaires were administered at baseline, immediately after the intervention, and 3 months after the intervention. The intervention’s effectiveness was evaluated using generalized linear mixed models. Results: A total of 352 dyads completed the study, giving an attrition rate of 2.2% (8/360). At 3 months after the intervention, the intervention group showed significantly reduced child’s screen time compared with the control group (β=−202.29, 95% CI −224.48 to −180.10; P<.001). Parental outcome scores also improved in the intervention group as compared with that in the control group. Mother’s knowledge significantly increased (β=6.88, 95% CI 6.11-7.65; P<.001), whereas perception about the influence of screen time on the child’s well-being reduced (β=−.86, 95% CI −0.98 to −0.73; P<.001). There was also an increase in the mother’s self-efficacy to reduce screen time (β=1.59, 95% CI 1.48-1.70; P<.001) and increase physical activity (β=.07, 95% CI 0.06-0.09; P<.001), along with reduction in mother’s screen time (β=−70.43, 95% CI −91.51 to −49.35; P<.001). Conclusions: The Stop and Play intervention was effective in reducing screen time among preschool children from low socioeconomic families, while improving the associated parental factors. Therefore, integration into primary health care and preschool education programs is recommended. Mediation analysis is suggested to investigate the extent to which secondary outcomes are attributable to the child’s screen time, and long follow-up could evaluate the sustainability of this digital intervention. Trial Registration: Thai Clinical Trial Registry (TCTR) TCTR20201010002; https://tinyurl.com/5frpma4b %M 37140970 %R 10.2196/40955 %U https://www.jmir.org/2023/1/e40955 %U https://doi.org/10.2196/40955 %U http://www.ncbi.nlm.nih.gov/pubmed/37140970 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 11 %N %P e37105 %T Serious Games Based on Cognitive Bias Modification and Learned Helplessness Paradigms for the Treatment of Depression: Design and Acceptability Study %A Ghosh,Arka %A Agnihotri,Jagriti %A Bhalotia,Sradha %A Sati,Bharat Kumar %A Agarwal,Latika %A A,Akash %A Tandon,Swastika %A Meena,Komal %A Raj,Shreyash %A Azad,Yatin %A Gupta,Silky %A Gupta,Nitin %+ Department of Biological Sciences and Bioengineering, Indian Institute of Technology Kanpur, Kalyanpur, Kanpur, 208016, India, 91 5122594384, guptan@iitk.ac.in %K serious games %K cognitive bias modification %K learned helplessness %K depression %K digital intervention %K mobile phone %D 2023 %7 3.5.2023 %9 Original Paper %J JMIR Serious Games %G English %X Background: Depression is a debilitating mental health disorder, with a large treatment gap. Recent years have seen a surge in digital interventions to bridge this treatment gap. Most of these interventions are based on computerized cognitive behavioral therapy. Despite the efficacy of computerized cognitive behavioral therapy–based interventions, their uptake is low and dropout rates are high. Cognitive bias modification (CBM) paradigms provide a complementary approach to digital interventions for depression. However, interventions based on CBM paradigms have been reported to be repetitive and boring. Objective: In this paper, we described the conceptualization, design, and acceptability of serious games based on CBM paradigms and the learned helplessness paradigm. Methods: We searched the literature for CBM paradigms that were shown to be effective in reducing depressive symptoms. For each of the CBM paradigms, we ideated how to create a game so that the gameplay was engaging while the active therapeutic component remained unchanged. Results: We developed 5 serious games based on the CBM paradigms and the learned helplessness paradigm. The games include various core elements of gamification, such as goals, challenges, feedback, rewards, progress, and fun. Overall, the games received positive acceptability ratings from 15 users. Conclusions: These games may help improve the effectiveness and engagement levels of computerized interventions for depression. %M 37133923 %R 10.2196/37105 %U https://games.jmir.org/2023/1/e37105 %U https://doi.org/10.2196/37105 %U http://www.ncbi.nlm.nih.gov/pubmed/37133923 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 8 %N %P e43292 %T Fitterfly Diabetes CGM Digital Therapeutics Program for Glycemic Control and Weight Management in People With Type 2 Diabetes Mellitus: Real-world Effectiveness Evaluation %A Joshi,Shilpa %A Verma,Ritika %A Lathia,Tejal %A Selvan,Chitra %A Tanna,Snehal %A Saraf,Amit %A Tiwaskar,Mangesh %A Modi,Alok %A Kalra,Sanjay %A K,Vasudevarao %A Chitale,Manoj %A Malde,Forum %A Abdul Khader,Mohammed %A Singal,Arbinder Kumar %+ Office of Chief Executive Officer, Fitterfly HealthTech Pvt Ltd, Street 503, Akshar BlueChip Corporate Park, Turbhe MIDC, Navi Mumbai, 400705, India, 91 8879698997, arbinder@fitterfly.com %K digital therapeutics %K glycemic control %K continuous glucose monitoring %K monitoring %K glucose %K diabetes %K type 2 diabetes %K decision-making %K model %K glycemic %K effectiveness %K mobile application %K application %K engagement %D 2023 %7 3.5.2023 %9 Original Paper %J JMIR Diabetes %G English %X Background: Digital therapeutic platforms facilitate health care through patient-centered strategies based on multidisciplinary teams and shared decision-making. Such platforms can be used for developing a dynamic model of diabetes care delivery, which can help in improving glycemic control by promoting long-term behavior changes in people with diabetes. Objective: This study aims to evaluate the real-world effectiveness of the Fitterfly Diabetes CGM digital therapeutics program for improving glycemic control in people with type 2 diabetes mellitus (T2DM) after the completion of 90 days in the program. Methods: We analyzed deidentified data of 109 participants in the Fitterfly Diabetes CGM program. This program was delivered through the Fitterfly mobile app coupled with continuous glucose monitoring (CGM) technology. This program consists of 3 phases: the first phase is observation, wherein the patient’s CGM readings are observed for 7 days (week 1); the second phase is the intervention; and the third phase aims at sustaining the lifestyle modification introduced during the second phase. The primary outcome of our study was the change in the participants’ hemoglobin A1c (HbA1c) levels after program completion. We also evaluated the changes in participant weight and BMI after the program, changes in the CGM metrics in the initial 2 weeks of the program, and the effects of participant engagement in the program on improving their clinical outcomes. Results: At the end of the 90 days of the program, the mean HbA1c levels, weight, and BMI of the participants were significantly reduced by 1.2% (SD 1.6%), 2.05 (SD 2.84) kg, and 0.74 (SD 1.02) kg/m2 from baseline values of 8.4% (SD 1.7%), 74.45 (SD 14.96) kg, and 27.44 (SD 4.69) kg/m2 in week 1, respectively (P<.001). The average blood glucose levels and time above range values showed a significant mean reduction by 16.44 (SD 32.05) mg/dL and 8.7% (SD 17.1%) in week 2 from week 1 baseline values of 152.90 (SD 51.63) mg/dL and 36.7% (SD 28.4%), respectively (P<.001 for both). Time in range values significantly improved by 7.1% (SD 16.7%) from a baseline value of 57.5% (SD 25%) in week 1 (P<.001). Of all the participants, 46.9% (50/109) showed HbA1c reduction ≥1% and 38.5% (42/109) showed weight loss ≥4%. The average number of times the mobile app was opened by each participant during the program was 108.80 (SD 127.91) times. Conclusions: Our study shows that participants in the Fitterfly Diabetes CGM program showed a significant improvement in their glycemic control and reduction in weight and BMI. They also showed a high level of engagement with the program. Weight reduction was significantly associated with higher participant engagement with the program. Thus, this digital therapeutic program can be considered as an effective tool for improving glycemic control in people with T2DM. %M 37133922 %R 10.2196/43292 %U https://diabetes.jmir.org/2023/1/e43292 %U https://doi.org/10.2196/43292 %U http://www.ncbi.nlm.nih.gov/pubmed/37133922 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e42548 %T Do Infrared Thermometers Hold Promise for an Effective Early Warning System for Emerging Respiratory Infectious Diseases? %A Li,Rui %A Shen,Mingwang %A Liu,Hanting %A Bai,Lu %A Zhang,Lei %+ China-Australia Joint Research Center for Infectious Diseases, School of Public Health, Xi'an Jiaotong University Health Science Center, 76 Yanta West Road, Xi'an, 710061, China, 86 02982655108, lei.zhang1@monash.edu %K respiratory infectious diseases %K early warning %K infrared thermometer %K theoretical framework %K economic burden %K outbreak prevention %K warning system %K community health %K infectious disease %K smartphone device %K digital health surveillance %D 2023 %7 3.5.2023 %9 Viewpoint %J JMIR Form Res %G English %X Background: Major respiratory infectious diseases, such as influenza, SARS-CoV, and SARS-CoV-2, have caused historic global pandemics with severe disease and economic burdens. Early warning and timely intervention are key to suppress such outbreaks. Objective: We propose a theoretical framework for a community-based early warning (EWS) system that will proactively detect temperature abnormalities in the community based on a collective network of infrared thermometer–enabled smartphone devices. Methods: We developed a framework for a community-based EWS and demonstrated its operation with a schematic flowchart. We emphasize the potential feasibility of the EWS and potential obstacles. Results: Overall, the framework uses advanced artificial intelligence (AI) technology on cloud computing platforms to identify the probability of an outbreak in a timely manner. It hinges on the detection of geospatial temperature abnormalities in the community based on mass data collection, cloud-based computing and analysis, decision-making, and feedback. The EWS may be feasible for implementation considering its public acceptance, technical practicality, and value for money. However, it is important that the proposed framework work in parallel or in combination with other early warning mechanisms due to a relatively long initial model training process. Conclusions: The framework, if implemented, may provide an important tool for important decisions for early prevention and control of respiratory diseases for health stakeholders. %M 37133929 %R 10.2196/42548 %U https://formative.jmir.org/2023/1/e42548 %U https://doi.org/10.2196/42548 %U http://www.ncbi.nlm.nih.gov/pubmed/37133929 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44840 %T Utilization and Effectiveness of a Message-Based Tobacco Cessation Program (mCessation) in the Chinese General Population: Longitudinal, Real-world Study %A Su,Zheng %A Wei,Xiaowen %A Cheng,Anqi %A Zhou,Xinmei %A Li,Jinxuan %A Qin,Rui %A Liu,Yi %A Xia,Xin %A Song,Qingqing %A Liu,Zhao %A Zhao,Liang %A Xiao,Dan %A Wang,Chen %+ Department of Tobacco Control and Prevention of Respiratory Diseases, China-Japan Friendship Hospital, Center of Respiratory Medicine, District Chaoyang, Beijing, 100021, China, 86 868 420 5425, danxiao@263.net %K smoking cessation %K real-world evidence %K text message %K general population %D 2023 %7 2.5.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Randomized controlled trials on text message interventions for smoking cessation have shown they are effective and recommended for tobacco control. However, the effectiveness in real-world settings is largely unknown, especially in low- and middle-income countries. Objective: This study aimed to provide real-world evidence about the utilization and effectiveness of a message-based tobacco cessation program (mCessation) in China. Methods: From May 2021 to September 2022, 16,746 people from the general population participated in the mCessation program provided by the World Health Organization. All participants received text messages on smoking cessation via instant messaging for 6 months, and they were also required to report smoking status. We randomly selected 2500 participants and interviewed them by telephone to determine the 7-day point prevalence abstinence rate at 6 months. Descriptive statistics were used to analyze population characteristics and abstinence rate. Logistic regression analysis was performed to explore risk factors for the abstinence rate. Results: Among the 2500 participants, the mean age was 35 years, and most (2407/2500, 96.20%) were male. The prevalence of tobacco dependence and light degree of tobacco dependence were 85.70% (2142/2500) and 89.10% (2228/2500), respectively. For respondents (953/2500, 38.10%), the 7-day point prevalence abstinence rate at 6 months was 21.90% (209/953). Participants older than 40 years or with tobacco dependence had significantly higher abstinence rates than those who were younger than 30 years old (odds ratio [OR] 1.77, 95% CI 1.06-3.29) or without dependence (OR 1.64, 95% CI 1.08-2.51), respectively. However, married people or heavily dependent smokers tended to find it more difficult to successfully quit smoking compared with unmarried people (OR 0.57, 95% CI 0.34-0.93) or lightly dependent smokers (OR 0.16, 95% CI 0.02-0.98), respectively. Conclusions: In a real-world setting, mCessation China was generally acceptable to men and lightly dependent smokers, and it could help 1 in 5 smokers aged 18 years to 67 years quit smoking. However, strategies to increase awareness of young and married adults may improve implementation and abstinence rates. %M 37129934 %R 10.2196/44840 %U https://www.jmir.org/2023/1/e44840 %U https://doi.org/10.2196/44840 %U http://www.ncbi.nlm.nih.gov/pubmed/37129934 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e41498 %T Participant Preferences for the Development of a Digitally Delivered Gardening Intervention to Improve Diet, Physical Activity, and Cardiovascular Health: Cross-sectional Study %A Veldheer,Susan %A Whitehead-Zimmers,Maxfield %A Bordner,Candace %A Watt,Benjamin %A Conroy,David E %A Schmitz,Kathryn H %A Sciamanna,Christopher %+ Department of Family and Community Medicine, Penn State College of Medicine, 90 Hope Dr., room 2120H, Hershey, PA, 17033, United States, 1 717 531 5625, sveldheer@psu.edu %K intervention development %K cardiovascular health %K gardening %K diet %K physical activity %K behavior change wheel %D 2023 %7 2.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Low dietary intake of fruits and vegetables and physical inactivity are 2 modifiable risk factors for cardiovascular disease. Fruit and vegetable gardening can provide access to fresh produce, and many gardening activities are considered moderate physical activity. This makes gardening interventions a potential strategy for cardiovascular disease risk reduction. Previously developed gardening interventions have relied on in-person delivery models, which limit scalability and reach. Objective: The purpose of this study was to ascertain participant insight on intervention components and topics of interest to inform a digitally delivered, gardening-focused, multiple health behavior change intervention. Methods: A web-based survey was delivered via Amazon Mechanical Turk (MTurk), including quantitative and open-ended questions. Eligible participants were aged ≥20 years, could read and write in English, were US residents, and had at least a 98% MTurk task approval rating. A multilevel screening process was used to identify and exclude respondents with response inattention, poor language fluency, or suspected automated web robots (bots). Participants were asked about their interest in gardening programming, their preferences for intervention delivery modalities (1-hour expert lectures, a series of brief <5-minute videos, or in-person meetings), and what information is needed to teach new gardeners. Comparisons were made between never gardeners (NG) and ever gardeners (EG) in order to examine differences in perceptions based on prior experience. Quantitative data were summarized, and differences between groups were tested using chi-square tests. Qualitative data were coded and organized into intervention functions based on the Behavior Change Wheel. Results: A total of 465 participants were included (n=212, 45.6% NG and n=253, 54.4% EG). There was a high level of program interest overall (n=355, 76.3%), though interest was higher in EG (142/212, 67% NG; 213/253, 84.2% EG; P<.001). The majority of participants (n=282, 60.7%) preferred a series of brief <5-minute videos (136/212, 64.2% NG; 146/253, 57.7% EG; P=.16) over 1-hour lectures (29/212, 13.7% NG; 50/253, 19.8% EG; P=.08) or in-person delivery modes (47/212, 22.2% NG; 57/253, 22.5% EG; P=.93). Intervention functions identified were education and training (performing fundamental gardening and cooking activities), environmental restructuring (eg, social support), enablement (provision of tools or seeds), persuasion (offering encouragement and highlighting the benefits of gardening), and modeling (using content experts and participant testimonials). Content areas identified included the full lifecycle of gardening activities, from the fundamentals of preparing a garden site, planting and maintenance to harvesting and cooking. Conclusions: In a sample of potential web-based learners, participants were interested in a digitally delivered gardening program. They preferred brief videos for content delivery and suggested content topics that encompassed how to garden from planting to harvesting and cooking. The next step in this line of work is to identify target behavior change techniques and pilot test the intervention to assess participant acceptability and preliminary efficacy. %M 37129952 %R 10.2196/41498 %U https://formative.jmir.org/2023/1/e41498 %U https://doi.org/10.2196/41498 %U http://www.ncbi.nlm.nih.gov/pubmed/37129952 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e44980 %T Developing a System of Health Support for Young People Experiencing First-Episode Psychosis: Protocol for a Co-design Process %A Jenkins,Matthew %A Gardiner,Tracey %A Pekepo,Crystal %A Ramritu,Pāyal %A Drysdale,Briony %A Every-Palmer,Susanna %A Chinn,Victoria %+ Department of Psychological Medicine, University of Otago Wellington, 29 Brandon Street, Lambton Quay, Wellington / Te Whanganui-a-Tara, 6011, New Zealand, 64 221740904, matthew.jenkins@otago.ac.nz %K psychosis %K health %K well-being %K co-design %K lived experience %K early intervention %D 2023 %7 2.5.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: People living with psychosis face a substantially increased risk of poor psychological well-being and physical health and premature mortality. Encouraging positive health behaviors from an early stage is crucial to the health and well-being of this population but is often overshadowed by symptom management within early intervention services. Objective: Experience-based co-design is a participant-centered approach that aims to combine service user narratives with service design methods to design systems of support for health and well-being. This study aims to use experience-based co-design principles to co-design a system that supports the health and well-being of young people experiencing first-episode psychosis (FEP), which considers the lived experience of these people within the context of early intervention services. We also aim to develop a set of principles to guide future systems to support the health and well-being of young people experiencing FEP. Methods: Up to 15 young people living with FEP aged 16 to 24 years who are service users of early intervention services in psychosis, their immediate support networks (family or friends), and health professionals involved with early intervention services in psychosis will be invited to participate in a series of co-design workshops. Data will be collected in various forms, including expressive forms (eg, art and spoken word) and traditional methods (interview transcription and surveys), with phenomenographic and thematic analyses being used to understand these data. Furthermore, the co-design process will draw upon indigenous (Māori) knowledge and the lived experience of mental health services from the perspectives of the members of the research team. The co-design process will be evaluated in terms of acceptability from the perspective of service users via rating scales and interviews. The study will be conducted within the Lower North Island in Aotearoa New Zealand. Results: Data collection will be performed between August 2022 and February 2023. Drawing from extended consultations with service users and service providers, we have developed a robust co-design process with which we intend to collect rich qualitative and quantitative data. The results of this process will be used to create a system of support that can be immediately applied and as preliminary evidence for funding and resource applications to deliver and evaluate a “full” version of the co-designed system of support. Conclusions: The co-designed system of support and accompanying set of principles will offer a potentially impactful health and well-being intervention for young people experiencing FEP in Aotearoa New Zealand. Furthermore, making the co-design process transparent will further the field in terms of providing a blueprint for this form of participant-focused research. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12622001323718; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384775&isReview=true International Registered Report Identifier (IRRID): DERR1-10.2196/44980 %M 37129953 %R 10.2196/44980 %U https://www.researchprotocols.org/2023/1/e44980 %U https://doi.org/10.2196/44980 %U http://www.ncbi.nlm.nih.gov/pubmed/37129953 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e40472 %T Efficacy of Web-Based, Guided Self-help Cognitive Behavioral Therapy–Enhanced for Binge Eating Disorder: Randomized Controlled Trial %A Melisse,Bernou %A Berg,Elske van den %A Jonge,Margo de %A Blankers,Matthijs %A Furth,Eric van %A Dekker,Jack %A Beurs,Edwin de %+ Novarum Center for Eating Disorders, Laan van de Helende Meesters 2, Amstelveen, 1186 AM, Netherlands, 31 621958289, bernou.melisse@novarum.nl %K randomized controlled trial %K RCT %K binge eating disorder %K BED %K guided self-help %K cognitive behavioral therapy–enhanced %K CBT-E %D 2023 %7 1.5.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Owing to the gap between treatment supply and demand, there are long waiting periods for patients with binge eating disorder, and there is an urgent need to increase their access to specialized treatment. Guided self-help cognitive behavioral therapy–enhanced (CBT-E) may have great advantages for patients if its efficacy can be established. Objective: The aim of this study was to examine the efficacy of guided self-help CBT-E compared with that of a delayed-treatment control condition. Methods: A single-blind 2-arm randomized controlled trial was designed to evaluate guided self-help CBT-E according to an intention-to-treat analysis. A total of 180 patients were randomly assigned to guided self-help CBT-E (n=90, 50%) or the delayed-treatment control condition (n=90, 50%) for which guided self-help CBT-E was provided after the initial 12-week delay. The primary outcome was reduction in binges. The secondary outcome was full recovery at the end of treatment, as measured using the Eating Disorder Examination during the last 4 weeks of treatment. A linear mixed model analysis was performed to compare treatment outcomes at the end of treatment. A second linear mixed model analysis was performed to measure between- and within-group effects for up to 24 weeks of follow-up. The Eating Disorder Examination–Questionnaire and clinical impairment assessment were conducted before and after treatment and during follow-up. In addition, dropout rates were assessed in both conditions. Results: During the last 4 weeks of treatment, objective binges reduced from an average of 19 (SD 16) to 3 (SD 5) binges, and 40% (36/90) showed full recovery in the guided self-help CBT-E group. Between-group effect size (Cohen d) was 1.0 for objective binges. At follow-up, after both groups received treatment, there was no longer a difference between the groups. Of the 180 participants, 142 (78.9%) completed treatment. The overall treatment dropout appeared to be associated with gender, level of education, and number of objective binges at baseline but not with treatment condition. Conclusions: This is the first study to investigate the efficacy of guided self-help CBT-E. Guided self-help CBT-E appeared to be an efficacious treatment. This study’s findings underscore the international guidelines recommending this type of treatment for binge eating disorder. Trial Registration: Netherlands Trial Registry (NTR) NL7994; https://trialsearch.who.int/Trial2.aspx?TrialID=NL7994 International Registered Report Identifier (IRRID): RR2-10.1186/s12888-020-02604-1 %M 37126386 %R 10.2196/40472 %U https://www.jmir.org/2023/1/e40472 %U https://doi.org/10.2196/40472 %U http://www.ncbi.nlm.nih.gov/pubmed/37126386 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43862 %T Conversational Agent Interventions for Mental Health Problems: Systematic Review and Meta-analysis of Randomized Controlled Trials %A He,Yuhao %A Yang,Li %A Qian,Chunlian %A Li,Tong %A Su,Zhengyuan %A Zhang,Qiang %A Hou,Xiangqing %+ Institute of Applied Psychology, College of Education, Tianjin University, 135 Yaguan Road, Jinnan District, Tianjin, 300354, China, 86 15034071215, 2020212056@tju.edu.cn %K chatbot and conversational agent %K mental health %K meta-analysis %K depression %K anxiety %K quality of life %K stress %K mobile health %K mHealth %K digital medicine %K meta-regression %K mobile phone %D 2023 %7 28.4.2023 %9 Review %J J Med Internet Res %G English %X Background: Mental health problems are a crucial global public health concern. Owing to their cost-effectiveness and accessibility, conversational agent interventions (CAIs) are promising in the field of mental health care. Objective: This study aims to present a thorough summary of the traits of CAIs available for a range of mental health problems, find evidence of efficacy, and analyze the statistically significant moderators of efficacy via a meta-analysis of randomized controlled trial. Methods: Web-based databases (Embase, MEDLINE, PsycINFO, CINAHL, Web of Science, and Cochrane) were systematically searched dated from the establishment of the database to October 30, 2021, and updated to May 1, 2022. Randomized controlled trials comparing CAIs with any other type of control condition in improving depressive symptoms, generalized anxiety symptoms, specific anxiety symptoms, quality of life or well-being, general distress, stress, mental disorder symptoms, psychosomatic disease symptoms, and positive and negative affect were considered eligible. This study followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Data were extracted by 2 independent reviewers, checked by a third reviewer, and pooled using both random effect models and fixed effects models. Hedges g was chosen as the effect size. Results: Of the 6900 identified records, a total of 32 studies were included, involving 6089 participants. CAIs showed statistically significant short-term effects compared with control conditions in improving depressive symptoms (g=0.29, 95% CI 0.20-0.38), generalized anxiety symptoms (g=0.29, 95% CI 0.21-0.36), specific anxiety symptoms (g=0.47, 95% CI 0.07-0.86), quality of life or well-being (g=0.27, 95% CI 0.16-0.39), general distress (g=0.33, 95% CI 0.20-0.45), stress (g=0.24, 95% CI 0.08-0.41), mental disorder symptoms (g=0.36, 95% CI 0.17-0.54), psychosomatic disease symptoms (g=0.62, 95% CI 0.14-1.11), and negative affect (g=0.28, 95% CI 0.05-0.51). However, the long-term effects of CAIs for the most mental health outcomes were not statistically significant (g=−0.04 to 0.39). Personalization and empathic response were 2 critical facilitators of efficacy. The longer duration of interaction with conversational agents was associated with the larger pooled effect sizes. Conclusions: The findings show that CAIs are research-proven interventions that ought to be implemented more widely in mental health care. CAIs are effective and easily acceptable for those with mental health problems. The clinical application of this novel digital technology will conserve human health resources and optimize the allocation of mental health services. Trial Registration: PROSPERO CRD42022350130; https://tinyurl.com/mvhk6w9p %M 37115595 %R 10.2196/43862 %U https://www.jmir.org/2023/1/e43862 %U https://doi.org/10.2196/43862 %U http://www.ncbi.nlm.nih.gov/pubmed/37115595 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e41926 %T Effects of Smartphone-Based Remote Interventions on Dietary Intake, Physical Activity, Weight Control, and Related Health Benefits Among the Older Population With Overweight and Obesity in China: Randomized Controlled Trial %A Zhang,Na %A Zhou,Mingzhu %A Li,Muxia %A Ma,Guansheng %+ Department of Nutrition and Food Hygiene, School of Public Health, Peking University, 38 Xue Yuan Road, Hai Dian District, Beijing, 100191, China, 86 010 82805266, mags@bjmu.edu.cn %K overweight and obesity %K remote interventions %K older population %K dietary intake %K physical activity %K weight management %K health %K mobile phone %D 2023 %7 28.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Traditional health management requires many human and material resources and cannot meet the growing needs. Remote medical technology provides an opportunity for health management; however, the research on it is insufficient. Objective: The objective of this study was to assess the effects of remote interventions on weight management. Methods: In this randomized controlled study, 750 participants were randomly assigned to a remote dietary and physical activity intervention group (group DPI), remote physical activity intervention group (group PI), or control group (group C). At baseline (time 1), day 45 (time 2), and day 90 (time 3), data were collected, including data on dietary intake, physical activity, indexes related to weight control, and health benefits. Results: A total of 85.6% (642/750) of participants completed the follow-up. Compared with group C, group DPI showed a significant decrease in energy intake (−581 vs −82 kcal; P<.05), protein intake (−17 vs −3 g; P<.05), fat intake (−8 vs 3 g; P<.05), and carbohydrate intake (−106.5 vs −4.7 g; P<.05) at time 3. Compared with time 1, groups DPI and PI showed a significant decrease in cereal and potato intake (P<.05). Compared with time 1, the physical activity levels related to transportation (group PI: 693 vs 597 metabolic equivalent [MET]–min/week, group C: 693 vs 594 MET-min/week; P<.05) and housework and gardening (group PI: 11 vs 0 MET-min/week, group C: 11 vs 4 MET-min/week; P<.05) in groups PI and C were improved at time 3. Compared with groups PI and C, group DPI showed a significant decrease in weight (−1.56 vs −0.86 kg and −1.56 vs −0.66 kg, respectively; P<.05) and BMI (−0.61 vs −0.33 kg/m2 and −0.61 vs −0.27 kg/m2, respectively; P<.05) at time 2. Compared with groups PI and C, group DPI showed a significant decrease in body weight (−4.11 vs −1.01 kg and −4.11 vs −0.83 kg, respectively; P<.05) and BMI (−1.61 vs −0.40 kg/m2 and −1.61 vs −0.33 kg/m2, respectively; P<.05) at time 3. Compared with group C, group DPI showed a significant decrease in triglyceride (−0.06 vs 0.32 mmol/L; P<.05) at time 2. Compared with groups PI and C, group DPI showed a significant decrease in systolic blood pressure (−8.15 vs −3.04 mmHg and −8.15 vs −3.80 mmHg, respectively; P<.05), triglyceride (−0.48 vs 0.11 mmol/L and −0.48 vs 0.18 mmol/L, respectively; P<.05), and fasting blood glucose (−0.77 vs 0.43 mmol/L and −0.77 vs 0.14 mmol/L, respectively; P<.05). There were significant differences in high-density lipoprotein cholesterol (−0.00 vs −0.07 mmol/L; P<.05) and hemoglobin A1c (−0.19% vs −0.07%; P<.05) between groups DPI and C. Conclusions: Remote dietary and physical activity interventions can improve dietary intake among participants with overweight and obesity, are beneficial for weight control, and have potential health benefits. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900023355; https://www.chictr.org.cn/showproj.html?proj=38976 %M 37115608 %R 10.2196/41926 %U https://www.jmir.org/2023/1/e41926 %U https://doi.org/10.2196/41926 %U http://www.ncbi.nlm.nih.gov/pubmed/37115608 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e39331 %T A New Digital Health Program for Patients With Inflammatory Bowel Disease: Preliminary Program Evaluation %A Oddsson,Saemundur Jon %A Gunnarsdottir,Thrudur %A Johannsdottir,Lilja Gudrun %A Amundadottir,Maria Lovisa %A Frimannsdottir,Arna %A Molander,Pauliina %A Ylanne,Anna Karoliina %A Islind,Anna Sigridur %A Oskarsdottir,Maria %A Thorgeirsson,Tryggvi %+ Sidekick Health Digital Therapeutics, Vallakór 4, Kópavogur, Reykjavik, 203, Iceland, 354 78 20 401, thrudur@sidekickhealth.com %K inflammatory bowel disease %K self-management %K stress %K fatigue %K sleep %K digital platform %K digital therapeutics %K real-world evidence %K mobile phone %D 2023 %7 28.4.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Inflammatory bowel disease (IBD) causes chronic inflammation of the gastrointestinal tract. IBD is characterized by an unpredictable disease course that varies greatly between individuals and alternates between the periods of relapse and remission. A low energy level (fatigue) is a common symptom, whereas stress and reduced sleep quality may be the triggering factors. Therapeutic guidelines call for effective disease assessment, early intervention, and personalized care using a treat-to-target approach, which may be difficult to achieve through typical time- and resource-constrained standard care. Providing patients with a digital health program that incorporates helpful self-management features and patient support to complement standard care may be optimal for improving the disease course. Objective: This study aimed to perform a preliminary program evaluation, analyzing engagement and preliminary effectiveness and the effect on participants’ energy levels (fatigue), stress, and sleep quality, of a newly developed 16-week digital health program (SK-311 and SK-321) for patients with IBD. Methods: Adults with IBD were recruited to participate in a real-world, live, digital health program via Finnish IBD patient association websites and social media. No inclusion or exclusion criteria were applied for this study. Baseline characteristics were entered by the participants upon sign-up. Platform engagement was measured by tracking the participants’ event logs. The outcome measures of stress, energy levels (fatigue), and quality of sleep were reported by participants through the platform. Results: Of the 444 adults who registered for the digital health program, 205 (46.2%) were included in the intention-to-treat sample. The intention-to-treat participants logged events on average 41 times per week (5.9 times per day) during the weeks in which they were active on the digital platform. More women than men participated in the intervention (126/205, 88.7%). The mean age of the participants was 40.3 (SD 11.5) years, and their mean BMI was 27.9 (SD 6.0) kg/m2. In total, 80 people provided the required outcome measures during weeks 12 to 16 (completers). Treatment completion was strongly predicted by the number of active days in week 1. Analysis of the completers (80/205, 39%) showed significant improvements for stress (t79=4.57; P<.001; percentage change=−23.26%) and energy levels (t79=−2.44; P=.017; percentage change=9.48%); however, no significant improvements were observed for quality of sleep (t79=−1.32; P=.19). Conclusions: These results support the feasibility of a digital health program for patients with IBD (SK-311 and SK-321) and suggest that treatment completion might have a substantial positive effect on patient-reported stress and energy levels in a real-world setting. These findings are promising and provide initial support for using the Sidekick Health digital health program to supplement standard care for patients with IBD. %M 37115598 %R 10.2196/39331 %U https://formative.jmir.org/2023/1/e39331 %U https://doi.org/10.2196/39331 %U http://www.ncbi.nlm.nih.gov/pubmed/37115598 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45040 %T Evaluation of Various Support Intensities of Digital Mental Health Treatment for Reducing Anxiety and Depression in Adults: Protocol for a Mixed Methods, Adaptive, Randomized Clinical Trial %A Andrews,Brooke %A Klein,Britt %A McLaren,Suzanne %A Watson,Shaun %A Corboy,Denise %+ Health Innovation & Transformation Centre, Federation University Australia, PO BOX 663, Ballarat, 3353, Australia, 61 53279623 ext 9623, b.andrews@federation.edu.au %K video chat therapy %K therapist assistance %K self-help %K transdiagnostic %K digital intervention %K anxiety %K depression %K comorbidity %D 2023 %7 28.4.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Anxiety and depression are leading causes of disease worldwide, requiring timely access to evidence-based treatment. Digital mental health (dMH) interventions increase accessibility to evidence-based psychological services delivered in a variety of web-based formats (eg, self-help and therapist-assisted interventions). Robust and rigorous studies of adaptive web-based intervention designs are scarce. No identified randomized clinical trial has investigated the efficacy of a 2-stage adaptive design, whereby the program-only condition or no support dMH treatment program is augmented by either low or high therapist assistance, if a participant does not improve or engage in the program-only condition. Objective: The primary objective is to assess whether low or high therapist-assisted support delivered via video chat is more effective in reducing anxiety and depressive symptoms compared with a dMH program–only condition. The secondary objective is to evaluate the role of motivation; self-efficacy; and preferences in participant engagement, adherence, and clinical outcomes (anxiety and depression symptoms) among the 3 treatment conditions (program only, low-intensity therapist assistance, and high-intensity therapist assistance). A mixed methods analysis of factors affecting participant attrition, participant reasons for nonengagement and withdrawal, and therapist training and implementation of dMH interventions will be completed. Qualitative data regarding participant and therapist experiences and satisfaction with video chat assessment and treatment will also be analyzed. Methods: Australian adults (N=137) with symptoms or a diagnosis of anxiety or depression will be screened for eligibility and given access to the 8-module Life Flex dMH treatment program. On day 15, participants who meet the augmentation criteria will be stepped up via block randomization to receive therapist assistance delivered via video chat for either 10 minutes (low intensity) or 50 minutes (high intensity) per week. This adaptive trial will implement a mixed methods design, with outcomes assessed before the intervention (week 0), during the intervention (weeks 3 and 6), after the intervention (week 9), and at the 3-month follow-up (week 21). Results: The primary outcome measures are for anxiety (Generalized Anxiety Disorder–7) and depression severity (Patient Health Questionnaire–9). Measures of working alliance, health status, health resources, preferences, self-efficacy, and motivation will be used for secondary outcomes. Qualitative methods will be used to explore participant and therapist experiences of video chat assessment and treatment, participant reasons for withdrawal and nonengagement, and therapist training and implementation experiences. Data collection commenced in November 2020 and was completed at the end of March 2022. Conclusions: This is the first mixed methods adaptive trial to explore the comparative efficacy of different intensity levels of self-help and a therapist-assisted dMH intervention program delivered via video chat for adults with anxiety or depression. Anticipated results may have implications for the implementation of dMH interventions. Trial Registration: Australian and New Zealand Clinical Trials Registry 12620000422921; https://tinyurl.com/t9cyu372 International Registered Report Identifier (IRRID): RR1-10.2196/45040 %M 37115623 %R 10.2196/45040 %U https://www.researchprotocols.org/2023/1/e45040 %U https://doi.org/10.2196/45040 %U http://www.ncbi.nlm.nih.gov/pubmed/37115623 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e31694 %T My Health, My Life, My Way—An Inclusive Web-Based Self-management Program for People With Disabilities Living With Chronic Conditions: Protocol for a Multiphase Optimization Strategy Study %A Evans,Eric %A Zengul,Ayse %A Knight,Amy %A Willig,Amanda %A Cherrington,Andrea %A Mehta,Tapan %A Thirumalai,Mohanraj %+ Department of Health Services Administration, School of Health Professions, University of Alabama at Birmingham, 1716 9th Ave S, Birmingham, AL, 35233, United States, 1 2059347189, mohanraj@uab.edu %K telehealth %K health coaching %K artificial intelligence %K chronic conditions %K mobile phone %D 2023 %7 28.4.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Individuals with disabilities living with chronic health conditions require self-management programs that are accessible, sustainable, inclusive, and adaptable. Health coaching is an effective approach to promoting behavior change in self-management. Health coaching combined with telehealth technology has the potential to improve the overall quality of, and access to, health services. Objective: This protocol outlines the study design for implementing the My Health, My Life, My Way intervention. The study will assess the feasibility, acceptability, and preliminary efficacy of the intervention for people with disabilities and optimize it. Methods: The My Health, My Life, My Way study is a 4-arm randomized controlled trial evaluating the delivery of a 6-month intervention involving telecoaching, inclusive educational content, and technology access for 200 individuals with chronic conditions and physical disabilities. This study uses the engineering-inspired multiphase optimization strategy (MOST) framework to evaluate intervention components and assess whether a combination or lack of individual elements influences behavior. Participants will be randomized to 1 of 4 study arms: scheduled coaching calls and gamified rewards, no scheduled coaching calls and gamified rewards, scheduled coaching calls and flat rewards, and no scheduled coaching calls and flat rewards. Results: The My Health, My Life, My Way study was approved by the institutional review board of the University of Alabama at Birmingham, and recruitment and enrollment will begin in May 2023. Data analysis is expected to be completed within 6 months of ending data collection. This clinical trial protocol was developed based on the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement. Conclusions: The My Health, My Life, My Way study will help to optimize and improve our understanding of the feasibility and efficacy of a web-based self-management program for people with physical disabilities and chronic conditions. More specifically, My Health, My Life, My Way will determine which combination of interventions (coaching calls and gamification) will result in increased participation in self-management programming. The My Health, My Life, My Way intervention has the potential to become a scalable and novel method to successfully manage chronic conditions in people with disabilities. Trial Registration: ClinicalTrials.gov NCT05481593; https://clinicaltrials.gov/ct2/show/NCT05481593 International Registered Report Identifier (IRRID): PRR1-10.2196/31694 %M 37115620 %R 10.2196/31694 %U https://www.researchprotocols.org/2023/1/e31694 %U https://doi.org/10.2196/31694 %U http://www.ncbi.nlm.nih.gov/pubmed/37115620 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44256 %T Evaluation of the Effectiveness of Telehealth Chronic Disease Management System: Systematic Review and Meta-analysis %A Xiao,Ziyan %A Han,Xiuping %+ Research Center Intelligent Equipment and Technology, Yangtze Delta Region Institute of Tsinghua University, No. 705, Yatai Road, Nanhu District, Jiaxing, Zhejiang, 314000, China, 86 0573 82582265, 396667279@qq.com %K telehealth chronic management system %K management system %K effectiveness evaluation %K quality of life %K mental health %K depression %K anxiety %K fatigue %K self-management %K self-efficacy %K medical adherence %K disease management %K chronic condition %K chronic disease %K telemedicine %K meta analyses %K meta analysis %K systematic %K review method %K search strategy %K literature search %D 2023 %7 27.4.2023 %9 Review %J J Med Internet Res %G English %X Background: Long-term daily health monitoring and management play a more significant role in telehealth management systems nowadays, which require evaluation indicators to present patients’ general health conditions and become applicable to multiple chronic diseases. Objective: This study aims to evaluate the effectiveness of subjective indicators of telehealth chronic disease management system (TCDMS). Methods: We selected Web of Science, ScienceDirect, Scopus, Cochrane library, IEEE, and Chinese National Knowledge Infrastructure and Wanfang, a Chinese medical database, and searched papers published from January 1, 2015, to July 1, 2022, regarding randomized controlled trials on the effectiveness of the telehealth system on patients with chronic diseases. The narrative review summarized the questionnaire indicators presented in the selected studies. In the meta-analysis, Mean Difference (MD) and Standardized Mean Difference (SMD) with a 95% CI were pooled depending on whether the measurements were the same. Subgroup analysis was conducted if the heterogeneity was significant, and the number of studies was sufficient. Results: Twenty RCTs with 4153 patients were included in the qualitative review. Seventeen different questionnaire-based outcomes were found, within which quality of life, psychological well-being (including depression, anxiety, and fatigue), self-management, self-efficacy, and medical adherence were most frequently used. Ten RCTs with 2095 patients remained in meta-analysis. Compared to usual care, telehealth system can significantly improve the quality of life (SMD 0.44; 95% CI 0.16-0.73; P=.002), whereas no significant effects were found on depression (SMD −0.25; 95% CI −0.72 to 0.23; P=.30), anxiety (SMD −0.10; 95% CI −0.27 to 0.07; P=.71), fatigue (SMD −0.36; 95% CI −1.06 to 0.34; P<.001), and self-care (SMD 0.77; 95% CI −0.28-1.81; P<.001). In the subdomains of quality of life, telehealth statistically significantly improved physical functioning (SMD 0.15; 95% CI 0.02 to 0.29; P=.03), mental functioning (SMD 0.37; 95% CI 0.13-0.60; P=.002), and social functioning (SMD 0.64; 95% CI 0.00-1.29; P=.05), while there was no difference on cognitive functioning (MD 8.31; 95% CI −7.33 to 23.95; P=.30) and role functioning (MD 5.30; 95% CI −7.80 to 18.39; P=.43). Conclusions: TCDMS positively affected patients’ physical, mental, and social quality of life across multiple chronic diseases. However, no significant difference was found in depression, anxiety, fatigue, and self-care. Subjective questionnaires had the potential ability to evaluate the effectiveness of long-term telehealth monitoring and management. However, further well-designed experiments are warranted to validate TCDMS’s effects on subjective outcomes, especially when tested among different chronically ill groups. %M 37103993 %R 10.2196/44256 %U https://www.jmir.org/2023/1/e44256 %U https://doi.org/10.2196/44256 %U http://www.ncbi.nlm.nih.gov/pubmed/37103993 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44108 %T Efficacy of an mHealth Behavior Change Intervention for Promoting Physical Activity in the Workplace: Randomized Controlled Trial %A Alshagrawi,Salah %A Abidi,Syed Taha %+ Saudi Electronic University, 6730 Prince Mohammed Ibn Salman Ibn Abdulaziz Rd, Riyadh, 13316, Saudi Arabia, 966 580462066, s.alshagrawi@seu.edu.sa %K text messaging %K mobile phones %K physical activity %K eHealth %K pedometer %K smartphone %K activity tracker %K accelerometer %K behavioral %K workplace %K risk factor %K noncommunicable disease %K BMI %K wellness %D 2023 %7 27.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Insufficient physical activity (PA) is a well-established risk factor for several noncommunicable diseases such as cardiovascular diseases, cancer, diabetes, depression, and dementia. The World Health Organization (WHO) advises that individuals engage in 150 minutes of moderate PA per week or 75 minutes of intense PA per week. According to the WHO’s latest report, 23% of adults fail to meet the minimum recommended level of PA. The percentage was even higher in a recent global study that showed 27% of adults were insufficiently active and reported a 5% increase in the prevalence trend of insufficient PA between 2001 and 2016. The study also showed the rate of insufficient PA among countries varied significantly. For instance, it was estimated that 40% were insufficiently active in the United States, and the percentage was even higher in Saudi Arabia (more than 50%). Governments are actively developing policies and methods to successfully establish a PA-inducing environment that encourages a healthy lifestyle in order to address the global steady decline in PA. Objective: The purpose of this study was to determine the effectiveness of mobile health (mHealth) interventions, particularly SMS text messaging interventions, to improve PA and decrease BMI in healthy adults in the workplace. Methods: In this parallel, 2-arm randomized controlled trial, healthy adults (N=327) were randomized to receive an mHealth intervention (tailored text messages combined with self-monitoring (intervention; n=166) or no intervention (control; n=161). Adults who were fully employed in an academic institution and had limited PA during working hours were recruited for the study. Outcomes, such as PA and BMI, were assessed at baseline and 3 months later. Results: Results showed significant improvement in PA levels (weekly step counts) in the intervention group (β=1097, 95% CI 922-1272, P<.001). There was also a significant reduction in BMI (β=0.60, 95% CI 0.50-0.69, P<.001). Conclusions: Combining tailored text messages and self-monitoring interventions to improve PA and lower BMI was significantly effective and has the potential to leverage current methods to improve wellness among the public. %M 37103981 %R 10.2196/44108 %U https://www.jmir.org/2023/1/e44108 %U https://doi.org/10.2196/44108 %U http://www.ncbi.nlm.nih.gov/pubmed/37103981 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43432 %T Efficacy of a Mobile Phone–Based Intervention on Health Behaviors and HIV/AIDS Treatment Management: Randomized Controlled Trial %A Tran,Bach Xuan %A Bui,Thu Minh %A Do,Anh Linh %A Boyer,Laurent %A Auquier,Pascal %A Nguyen,Long Hoang %A Nguyen,Anh Hai Tran %A Ngo,Toan Van %A Latkin,Carl A %A Zhang,Melvyn W B %A Ho,Cyrus S H %A Ho,Roger C M %+ Institute of Preventive Medicine and Public Health, Hanoi Medical University, 1 Ton That Tung Street, Dong Da district, Hanoi, 100000, Vietnam, 84 888238399, bach.ipmph2@gmail.com %K mobile health %K HIV/AIDS %K treatment adherence %K self-efficacy %K behavior %K HIV %K AIDS %K treatment %K management %K care %K feasibility %K efficacy %K intervention %K mHealth %K behavior %K Vietnam %K application %D 2023 %7 27.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Antiretroviral therapy (ART) is considered the most important intervention for HIV-positive patients; thus, encouraging the use of and adherence to ART are vital to HIV treatment outcomes. Advances in web and mobile technologies hold potential in supporting HIV treatment management. Objective: The aim of this study was to evaluate the feasibility and efficacy of a theory-based mobile health (mHealth) intervention on health behaviors and HIV treatment adherence among patients with HIV/AIDS in Vietnam. Methods: We performed a randomized controlled trial on 425 HIV patients in two of the largest HIV clinics in Hanoi, Vietnam. Both the intervention group (238 patients) and the control group (187 patients) received regular consultations with doctors and then participated in 1-month and 3-month follow-up visits. Patients in the intervention group received a theory-driven smartphone app to facilitate medication adherence and self-efficacy in HIV patients. Measurements were developed based on the Health Belief Model, which included the visual analog scale of ART Adherence, HIV Treatment Adherence Self-Efficacy Scale, and HIV Symptom Management Self-Efficacy Scale. We also included the 9-item Patient Health Questionnaire (PHQ-9) to assess patients’ mental health throughout treatment. Results: In the intervention group, the adherence score increased significantly (β=1.07, 95% CI .24-1.90) after 1 month, whereas the HIV adherence self-efficacy was significantly higher after 3 months (β=2.17, 95% CI 2.07-2.27) compared to the control group. There was a positive but low level of change in risk behaviors such as drinking, smoking, and drug use. Factors related to positive change in adherence were being employed and having stable mental well-being (lower PHQ-9 scores). Factors associated with self-efficacy in treatment adherence and symptom management were gender, occupation, younger age, and having no other underlying conditions. A longer duration of ART increased treatment adherence but decreased self-efficacy in symptom management. Conclusions: Our study demonstrated that the mHealth app could improve the overall ART adherence self-efficacy of patients. Further studies with larger sample sizes and longer follow-up periods are needed to support our findings. Trial Registration: Thai Clinical Trials Registry TCTR20220928003; https://www.thaiclinicaltrials.org/show/TCTR20220928003 %M 37104001 %R 10.2196/43432 %U https://www.jmir.org/2023/1/e43432 %U https://doi.org/10.2196/43432 %U http://www.ncbi.nlm.nih.gov/pubmed/37104001 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e37839 %T Exploring the Acceptability, Feasibility, and Effectiveness of a Digital Parenting Program to Improve Parental Well-being After the Christchurch Earthquakes: Cluster-Randomized Trial %A Donkin,Liesje %A Merry,Sally %A Moor,Stephanie %A Mowat,Anna %A Hetrick,Sarah %A Hopkins,Sarah %A Seers,Kara %A Frampton,Chris %A D'Aeth,Lucy %+ Department of Psychological Medicine, School of Medicine, Faculty of Medical and Health Sciences, Waipapa Taumata Rau, The University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland, 1142, New Zealand, 64 21847886, liesje.donkin@aut.ac.nz %K psychology %K eHealth %K app %K parenting %K digital health %K children %K parent %K well-being %K earthquake %K cluster-randomized trial %K distress %K child %K mental health %D 2023 %7 27.4.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Up to 6 years after the 2011 Christchurch earthquakes, approximately one-third of parents in the Christchurch region reported difficulties managing the continuously high levels of distress their children were experiencing. In response, an app named Kākano was co-designed with parents to help them better support their children’s mental health. Objective: The objective of this study was to evaluate the acceptability, feasibility, and effectiveness of Kākano, a mobile parenting app to increase parental confidence in supporting children struggling with their mental health. Methods: A cluster-randomized delayed access controlled trial was carried out in the Christchurch region between July 2019 and January 2020. Parents were recruited through schools and block randomized to receive immediate or delayed access to Kākano. Participants were given access to the Kākano app for 4 weeks and encouraged to use it weekly. Web-based pre- and postintervention measurements were undertaken. Results: A total of 231 participants enrolled in the Kākano trial, with 205 (88.7%) participants completing baseline measures and being randomized (101 in the intervention group and 104 in the delayed access control group). Of these, 41 (20%) provided full outcome data, of which 19 (18.2%) were for delayed access and 21 (20.8%) were for the immediate Kākano intervention. Among those retained in the trial, there was a significant difference in the mean change between groups favoring Kākano in the brief parenting assessment (F1,39=7, P=.012) but not in the Short Warwick-Edinburgh Mental Well-being Scale (F1,39=2.9, P=.099), parenting self-efficacy (F1,39=0.1, P=.805), family cohesion (F1,39=0.4, P=.538), or parenting sense of confidence (F1,40=0.6, P=.457). Waitlisted participants who completed the app after the waitlist period showed similar trends for the outcome measures with significant changes in the brief assessment of parenting and the Short Warwick-Edinburgh Mental Well-being Scale. No relationship between the level of app usage and outcome was found. Although the app was designed with parents, the low rate of completion of the trial was disappointing. Conclusions: Kākano is an app co-designed with parents to help manage their children’s mental health. There was a high rate of attrition, as is often seen in digital health interventions. However, for those who did complete the intervention, there was some indication of improved parental well-being and self-assessed parenting. Preliminary indications from this trial show that Kākano has promising acceptability, feasibility, and effectiveness, but further investigation is warranted. Trial Registration: Australia New Zealand Clinical Trials Registry ACTRN12619001040156; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377824&isReview=true %M 37103986 %R 10.2196/37839 %U https://formative.jmir.org/2023/1/e37839 %U https://doi.org/10.2196/37839 %U http://www.ncbi.nlm.nih.gov/pubmed/37103986 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e43849 %T Blood Pressure and Self-management in Black Women With Hypertension: Protocol Revisions to the Brain Relationships Among Information, Neuroprocessing, and Self-Management Study Due to the COVID-19 Pandemic %A Jones,Lenette M %A de Marco,Kayla %A Keener,Katharine %A Monroe,Korrey E %+ Health Behavior and Biological Sciences, School of Nursing, University of Michigan, 400 N. Ingalls, Room 2180, Ann Arbor, MI, 48109, United States, 1 7347631371, lenettew@umich.edu %K Black %K BRAINS %K COVID-19 pandemic %K eHealth %K Facebook %K hypertension %K protocol %K videoconferencing %K web-based %K women %D 2023 %7 27.4.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: The COVID-19 pandemic and the halt to in-person research activities beginning in March 2020 brought new challenges to protocol development and implementation. Due to the pandemic, we had to revise our protocol for the Brain Relationships Among Information, Neuroprocessing, and Self-Management (BRAINS) study, which was designed to examine health information behavior, brain activity, diabetes status, and self-management behavior among Black women with hypertension. Objective: This report outlines 7 steps describing how our research team (1) revised the BRAINS study protocol, (2) implemented a remote method of data collection, and (3) mitigated the challenges we faced. Methods: Prior to March 2020, Black women with hypertension were invited to participate in the BRAINS study to undergo a functional magnetic resonance imaging scan, complete surveys, have their blood pressure measured, and have their blood drawn. After these measures were collected, participants would receive phone calls from a dietician to complete two 24-hour dietary recalls using the Nutrition Data System for Research. Our revised protocol relied on a web-based, interactive approach. Participants received a study kit that included an Omron automatic home blood pressure monitor and a hemoglobin A1c kit from the DTIL laboratory. In a Zoom meeting with each participant, our team played an introductory video, administered surveys (via Qualtrics), and guided participants through measuring their blood pressure and performing a finger stick to collect a blood sample for hemoglobin A1c testing. We examined cognitive function using the TestMyBrain Digital Neuropsychology Toolkit, as we were unable to access the functional magnetic resonance imaging laboratory to assess brain activity. The 7 steps in revising our protocol were as follows: conceptualizing the move from in-person to remote study activities (step 1); contacting the funders (step 2); submitting changes for Institutional Review Board approval (step 3); preparing to implement the revised protocol (step 4); implementing the study changes (step 5); mitigating challenges (step 6); and evaluating protocol implementation (step 7). Results: Approximately 1700 individuals responded to web-based advertisements about the BRAINS study. A total of 131 individuals completed our eligibility screener. We conducted our first Zoom appointment in July 2020 and our last Zoom appointment in September 2020. Using our revised strategies, a total of 99 participants completed all study measures within a 3-month period. Conclusions: In this report, we discuss successes and challenges in revising our protocol and reaching our population of interest remotely, safely, and effectively. The information we have outlined can help researchers create similar protocols to reach and conduct research remotely with diverse populations, such as individuals who are unable to participate in studies in person. International Registered Report Identifier (IRRID): DERR1-10.2196/43849 %M 37104029 %R 10.2196/43849 %U https://www.researchprotocols.org/2023/1/e43849 %U https://doi.org/10.2196/43849 %U http://www.ncbi.nlm.nih.gov/pubmed/37104029 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e41911 %T A Personalized Mobile Cessation Intervention to Promote Smokers From the Preparation Stage to the Action Stage: Double-blind Randomized Controlled Trial %A Lin,Haoxiang %A Wang,Ying %A Xing,Yanling %A Han,Yinglian %A Zhang,Chengqian %A Luo,Ting %A Chang,Chun %+ School of Public Health, Peking University, 38 Xueyuanlu, Beijing, 100191, China, 86 13641338346, changchun@bjmu.edu.cn %K smoking cessation %K mobile health %K health education %K smoking %K behavior intervention %K behavior change %K support %K text message %K personalized %K smoking abstinence %K health behavior %K health promotion %D 2023 %7 26.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Most mobile cessation studies have found that such interventions have a higher quitting rate than interventions providing minimal smoking cessation support. However, why such interventions are effective has been almost unstudied by researchers. Objective: This paper describes the principles of the personalized mobile cessation intervention-based WeChat app and used generalized estimated equations to assess why a personalized mobile cessation intervention was more likely to promote smokers from the preparation stage to the action stage than a nonpersonalized intervention. Methods: This is a 2-arm, double-blind, randomized controlled trial in five cities in China. The intervention group received a personalized mobile cessation intervention. The control group received a nonpersonalized SMS text message smoking cessation intervention. All information was sent by the WeChat app. The outcomes were the change in protection motivation theory construct scores and the change in transtheoretical model stages. Results: A total of 722 participants were randomly assigned to the intervention or control group. Compared with those who received the nonpersonalized SMS text message intervention, smokers who received the personalized intervention presented lower intrinsic rewards, extrinsic rewards, and response costs. Intrinsic rewards were determinants of stage change, thus explaining why the intervention group was more likely to promote smokers from the preparation stage to the action stage (odds ratio 2.65, 95% CI 1.41-4.98). Conclusions: This study identified the psychological determinants at different stages to facilitate smokers moving forward to the next stage of quitting behavior and provides a framework to explore why a smoking cessation intervention is effective. Trial Registration: Chinese Clinical Trial Registry ChiCTR2100041942; https://tinyurl.com/2hhx4m7f %M 37099360 %R 10.2196/41911 %U https://www.jmir.org/2023/1/e41911 %U https://doi.org/10.2196/41911 %U http://www.ncbi.nlm.nih.gov/pubmed/37099360 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e41005 %T An Unguided, Computerized Cognitive Behavioral Therapy Intervention (TreadWill) in a Lower Middle-Income Country: Pragmatic Randomized Controlled Trial %A Ghosh,Arka %A Cherian,Rithwik J %A Wagle,Surbhit %A Sharma,Parth %A Kannan,Karthikeyan R %A Bajpai,Alok %A Gupta,Nitin %+ Department of Biological Sciences and Bioengineering, Indian Institute of Technology Kanpur, IIT Campus, Kanpur, 208016, India, 91 5122594384, guptan@iitk.ac.in %K computerized cognitive behavioral therapy %K cCBT %K depression %K digital intervention %K mobile phone %D 2023 %7 26.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Globally, most individuals who are susceptible to depression do not receive adequate or timely treatment. Unguided computerized cognitive behavioral therapy (cCBT) has the potential to bridge this treatment gap. However, the real-world effectiveness of unguided cCBT interventions, particularly in low- and middle-income countries (LMICs), remains inconclusive. Objective: In this study, we aimed to report the design and development of a new unguided cCBT–based multicomponent intervention, TreadWill, and its pragmatic evaluation. TreadWill was designed to be fully automated, engaging, easy to use, and accessible to LMICs. Methods: To evaluate the effectiveness of TreadWill and the engagement level, we performed a double-blind, fully remote, and randomized controlled trial with 598 participants in India and analyzed the data using a completer’s analysis. Results: The users who completed at least half of the modules in TreadWill showed significant reduction in depression-related (P=.04) and anxiety-related (P=.02) symptoms compared with the waitlist control. Compared with a plain-text version with the same therapeutic content, the full-featured version of TreadWill showed significantly higher engagement (P=.01). Conclusions: Our study provides a new resource and evidence for the use of unguided cCBT as a scalable intervention in LMICs. Trial Registration: ClinicalTrials.gov NCT03445598; https://clinicaltrials.gov/ct2/show/NCT03445598 %M 37099376 %R 10.2196/41005 %U https://www.jmir.org/2023/1/e41005 %U https://doi.org/10.2196/41005 %U http://www.ncbi.nlm.nih.gov/pubmed/37099376 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e40176 %T Uptake of an App-Based Case Management Service for HIV-Positive Men Who Have Sex With Men in China: Process Evaluation Study %A Fan,Xiaoyan %A Ning,Ke %A Liu,Cong %A Zhong,Haidan %A Lau,Joseph T F %A Hao,Chun %A Hao,Yuantao %A Li,Jinghua %A Li,Linghua %A Gu,Jing %+ Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Zhong Shan 2nd road, #74, Yue Xiu District, Guangzhou, 510080, China, 86 020 87335413, gujing5@mail.sysu.edu.cn %K process evaluation %K mobile health %K mHealth %K HIV %K men who have sex with men %K MSM %K antiretroviral treatment %K ART %K case management %D 2023 %7 26.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Men who have sex with men (MSM) in China are disproportionately affected by the HIV epidemic, and medication adherence to antiretroviral treatment in this vulnerable population is suboptimal. To address this issue, we developed an app-based case management service with multiple components, informed by the Information Motivation Behavioral skills model. Objective: We aimed to conduct a process evaluation for the implementation of an innovative app-based intervention guided by the Linnan and Steckler framework. Methods: Process evaluation was performed alongside a randomized controlled trial in the largest HIV clinic in Guangzhou, China. Eligible participants were HIV-positive MSM aged ≥18 years planning to initiate treatment on the day of recruitment. The app-based intervention had 4 components: web-based communication with case managers, educational articles, supportive service information (eg, information on mental health care and rehabilitation service), and hospital visit reminders. Process evaluation indicators of the intervention include dose delivered, dose received, fidelity, and satisfaction. The behavioral outcome was adherence to antiretroviral treatment at month 1, and Information Motivation Behavioral skills model scores were the intermediate outcome. Logistic and linear regression was used to investigate the association between intervention uptake and outcomes, controlling for potential confounders. Results: A total of 344 MSM were recruited from March 19, 2019, to January 13, 2020, and 172 were randomized to the intervention group. At month 1 follow-up, there was no significant difference in the proportion of adherent participants between the intervention and control groups (66/144, 45.8% vs 57/134, 42.5%; P=.28). In the intervention group, 120 participants engaged in web-based communication with case managers and 158 accessed at least 1 of the delivered articles. The primary concern captured in the web-based conversation was the side effects of the medication (114/374, 30.5%), which was also one of the most popular educational articles topics. The majority (124/144, 86.1%) of participants that completed the month 1 survey rated the intervention as “very helpful” or “helpful.” The number of educational articles accessed was associated with adequate adherence in the intervention group (odds ratio 1.08, 95% CI 1.02-1.15; P=.009). The intervention also improved the motivation score after adjusting for baseline values (β=2.34, 95% CI 0.77-3.91; P=.004). However, the number of web-based conversations, regardless of conversation features, was associated with lower motivation scores in the intervention group. Conclusions: The intervention was well-received. Delivering educational resources of interest may enhance medication adherence. The uptake of the web-based communication component could serve as an indicator of real-life difficulties and could be used by case managers to identify potential inadequate adherence. Trial Registration: Clinicaltrial.gov NCT03860116; https://clinicaltrials.gov/ct2/show/NCT03860116 International Registered Report Identifier (IRRID): RR2-10.1186/s12889-020-8171-5 %M 37099367 %R 10.2196/40176 %U https://www.jmir.org/2023/1/e40176 %U https://doi.org/10.2196/40176 %U http://www.ncbi.nlm.nih.gov/pubmed/37099367 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e41428 %T An Integrative Engagement Model of Digital Psychotherapy: Exploratory Focus Group Findings %A Zech,James M %A Johnson,Morgan %A Pullmann,Michael D %A Hull,Thomas D %A Althoff,Tim %A Munson,Sean A %A Fridling,Nicole %A Litvin,Boris %A Wu,Jerilyn %A Areán,Patricia A %+ Talkspace, 33 West 60th Street, New York, NY, 32304, United States, 1 2035177111, zech@psy.fsu.edu %K Health Action Process Approach %K lived informatics %K digital engagement %K messaging therapy %D 2023 %7 26.4.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital mental health interventions, such as 2-way and asynchronous messaging therapy, are a growing part of the mental health care treatment ecosystem, yet little is known about how users engage with these interventions over the course of their treatment journeys. User engagement, or client behaviors and therapeutic relationships that facilitate positive treatment outcomes, is a necessary condition for the effectiveness of any digital treatment. Developing a better understanding of the factors that impact user engagement can impact the overall effectiveness of digital psychotherapy. Mapping the user experience in digital therapy may be facilitated by integrating theories from several fields. Specifically, health science’s Health Action Process Approach and human-computer interaction’s Lived Informatics Model may be usefully synthesized with relational constructs from psychotherapy process–outcome research to identify the determinants of engagement in digital messaging therapy. Objective: This study aims to capture insights into digital therapy users’ engagement patterns through a qualitative analysis of focus group sessions. We aimed to synthesize emergent intrapersonal and relational determinants of engagement into an integrative framework of engagement in digital therapy. Methods: A total of 24 focus group participants were recruited to participate in 1 of 5 synchronous focus group sessions held between October and November 2021. Participant responses were coded by 2 researchers using thematic analysis. Results: Coders identified 10 relevant constructs and 24 subconstructs that can collectively account for users’ engagement and experience trajectories in the context of digital therapy. Although users’ engagement trajectories in digital therapy varied widely, they were principally informed by intrapsychic factors (eg, self-efficacy and outcome expectancy), interpersonal factors (eg, the therapeutic alliance and its rupture), and external factors (eg, treatment costs and social support). These constructs were organized into a proposed Integrative Engagement Model of Digital Psychotherapy. Notably, every participant in the focus groups indicated that their ability to connect with their therapist was among the most important factors that were considered in continuing or terminating treatment. Conclusions: Engagement in messaging therapy may be usefully approached through an interdisciplinary lens, linking constructs from health science, human-computer interaction studies, and clinical science in an integrative engagement framework. Taken together, our results suggest that users may not view the digital psychotherapy platform itself as a treatment so much as a means of gaining access to a helping provider, that is, users did not see themselves as engaging with a platform but instead viewed their experience as a healing relationship. The findings of this study suggest that a better understanding of user engagement is crucial for enhancing the effectiveness of digital mental health interventions, and future research should continue to explore the underlying factors that contribute to engagement in digital mental health interventions. Trial Registration: ClinicalTrials.gov NCT04507360; https://clinicaltrials.gov/ct2/show/NCT04507360 %M 37099363 %R 10.2196/41428 %U https://formative.jmir.org/2023/1/e41428 %U https://doi.org/10.2196/41428 %U http://www.ncbi.nlm.nih.gov/pubmed/37099363 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e38680 %T Effectiveness of the Lilly Connected Care Program in Improving Glycemic Management Among Patients With Type 2 Diabetes in China: Retrospective Real-world Study %A Su,Benli %A Chen,Yu %A Shen,Xingping %A Guo,Jianchao %A Ding,Yuchen %A Ma,Xiao %A Yang,Yuxin %A Liu,Dongfang %+ Department of Endocrinology, The Second Affiliated Hospital of Chongqing Medical University, Linjiang Road, No 76, Chongqing, 400010, China, 86 023 63693222, ldf023023@qq.com %K type 2 diabetes mellitus %K T2DM %K diabetes management %K Lilly Connected Care Program %K LCCP %K hemoglobin A1c %K real-word study %D 2023 %7 25.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Type 2 diabetes mellitus (T2DM) is a worldwide public health concern. Mobile health management platforms could be a potential way to achieve effective glycemic control. Objective: This study aimed to evaluate the real-world effectiveness of the Lilly Connected Care Program (LCCP) platform in glycemic control among patients with T2DM in China. Methods: This retrospective study included Chinese patients with T2DM (aged ≥18 years) from April 1, 2017, to January 31, 2020, for the LCCP group and from January 1, 2015, to January 31, 2020, for the non-LCCP group. Propensity score matching was used to match the LCCP and non-LCCP groups to reduce confounding, with covariates including age, sex, the duration of diabetes, baseline hemoglobin A1c (HbA1c), and the number of oral antidiabetic medication classes. HbA1c reduction over 4 months, the proportions of patients achieving an HbA1c reduction of ≥0.5% or ≥1%, and the proportions of patients reaching to target HbA1c level of ≤6.5% or <7% were compared between the LCCP and non-LCCP groups. Multivariate linear regression was used to assess factors associated with HbA1c reduction. Results: A total of 923 patients were included, among whom 303 pairs of patients were well matched after propensity score matching. HbA1c reduction during the 4-month follow-up was significantly larger in the LCCP group than the non-LCCP group (mean 2.21%, SD 2.37% vs mean 1.65%, SD 2.29%; P=.003). The LCCP group had a higher proportion of patients with an HbA1c reduction of ≥1% (209/303, 69% vs 174/303, 57.4%; P=.003) and ≥0.5% (229/303, 75.6% vs 206/303, 68%; P=.04). The proportions of patients reaching the target HbA1c level of ≤6.5% were significantly different between the LCCP and non-LCCP groups (88/303, 29% vs 61/303, 20.1%; P=.01), whereas the difference in the proportions of patients reaching the target HbA1c level of <7% was not statistically significant (LCCP vs non-LCCP: 128/303, 42.2% vs 109/303, 36%; P=.11). LCCP participation and higher baseline HbA1c were associated with a larger HbA1c reduction, whereas older age, longer diabetes duration, and higher baseline dose of premixed insulin analogue were associated with a smaller HbA1c reduction. Conclusions: The LCCP mobile platform was effective in glycemic control among patients with T2DM in China in the real world. %M 37097724 %R 10.2196/38680 %U https://www.jmir.org/2023/1/e38680 %U https://doi.org/10.2196/38680 %U http://www.ncbi.nlm.nih.gov/pubmed/37097724 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e34446 %T Work-Focused Versus Generic Internet-Based Interventions for Employees With Stress-Related Disorders: Randomized Controlled Trial %A Persson Asplund,Robert %A Asplund,Sofia %A von Buxhoeveden,Helene %A Delby,Hanna %A Eriksson,Karin %A Svenning Gerhardsson,Maurits %A Palm,Joachim %A Skyttberg,Thea %A Torstensson,Julia %A Ljótsson,Brjánn %A Carlbring,Per %A Andersson,Gerhard %+ Department of Behavioural Sciences and Learning, Linköping University, Campus Valla, I-huset, 3, Linköping, 58183, Sweden, 46 0707870231, robert.persson.asplund@liu.se %K stress %K burnout %K exhaustion %K work-focused %K internet-based %K intervention %K sickness absence %D 2023 %7 25.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: In recent decades, stress-related disorders have received more attention, with an increasing prevalence, especially within the working population. The internet provides new options for broad dissemination, and a growing body of evidence suggests that web-based interventions for stress might be effective. However, few studies have examined the efficacy of interventions in clinical samples and work-related outcomes. Objective: The aim of this study was to evaluate the efficacy of an internet-based cognitive behavioral intervention for stress-related disorders integrating work-related aspects (work-focused and internet-based cognitive behavioral therapy [W-iCBT]), compared with a generic internet-based cognitive behavioral therapy (iCBT) group and a waitlist control (WLC) group. Methods: In this trial, 182 employees, mainly employed in the health care, IT, or educational sector, who fulfilled the criteria for a stress-related disorder, were randomized to a 10-week W-iCBT (n=61, 33.5%), generic iCBT (n=61, 33.5%), or WLC (n=60, 33%). Self-rated questionnaires on perceived stress, burnout, exhaustion, and other mental health– and work-related outcomes were administered before and after the treatment and at 6- and 12-month follow-ups. Results: Compared with the WLC group, participants of the W-iCBT and iCBT groups showed an equal and significant reduction in the primary outcome (Shirom-Melamed Burnout Questionnaire [SMBQ]) from pretreatment to posttreatment assessment (Cohen d=1.00 and 0.83, respectively) and at the 6-month follow-up (Cohen d=0.74 and 0.74, respectively). Significant moderate-to-large effect sizes were also found in the secondary health- and work-related outcomes. The W-iCBT was the only group that exhibited significant effects on work ability and short-term sickness absence. Short-term sickness absence was 445 days lower than the WLC group and 324 days lower than the iCBT intervention group. However, no significant differences were found in terms of work experience or long-term sick leave. Conclusions: The work-focused and generic iCBT interventions proved to be superior compared with the control condition in reducing chronic stress and several other mental health–related symptoms. Interestingly, effects on work ability and short-term sickness absence were only seen between the W-iCBT intervention and the WLC groups. These preliminary results are promising, indicating that treatments that include work aspects may have the potential to accelerate recovery and reduce short-term sickness absence because of stress-related disorders. Trial Registration: ClinicalTrials.gov NCT05240495; https://clinicaltrials.gov/ct2/show/NCT05240495 (retrospectively registered) %M 37097739 %R 10.2196/34446 %U https://www.jmir.org/2023/1/e34446 %U https://doi.org/10.2196/34446 %U http://www.ncbi.nlm.nih.gov/pubmed/37097739 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e38545 %T Efficacy of the Aim2Be Intervention in Changing Lifestyle Behaviors Among Adolescents With Overweight and Obesity: Randomized Controlled Trial %A Tugault-Lafleur,Claire N %A De-Jongh González,Olivia %A Macdonald,Janice %A Bradbury,Jennifer %A Warshawski,Tom %A Ball,Geoff D C %A Morrison,Katherine %A Ho,Josephine %A Hamilton,Jill %A Buchholz,Annick %A Mâsse,Louise %+ School of Population and Public Health, BC Children's Hospital Research Institute, University of British Columbia, 4480 Oak Street, Rm F508, Vancouver, BC, V6H 3V4, Canada, 1 875 2000 ext 5563, lmasse@bcchr.ubc.ca %K mobile health %K mHealth %K childhood obesity %K lifestyle management %K adolescents %K randomized controlled trial %K RCT %K mobile phone %D 2023 %7 25.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Aim2Be is a gamified lifestyle app designed to promote lifestyle behavior changes among Canadian adolescents and their families. Objective: The primary aim was to test the efficacy of the Aim2Be app with support from a live coach to reduce weight outcomes (BMI Z score [zBMI]) and improve lifestyle behaviors among adolescents with overweight and obesity and their parents versus a waitlist control group over 3 months. The secondary aim was to compare health trajectories among waitlist control participants over 6 months (before and after receiving access to the app), assess whether support from a live coach enhanced intervention impact, and evaluate whether the app use influenced changes among intervention participants. Methods: A 2-arm parallel randomized controlled trial was conducted from November 2018 to June 2020. Adolescents aged 10 to 17 years with overweight or obesity and their parents were randomized into an intervention group (Aim2Be with a live coach for 6 months) or a waitlist control group (Aim2Be with no live coach; accessed after 3 months). Adolescents’ assessments at baseline and at 3 and 6 months included measured height and weight, 24-hour dietary recalls, and daily step counts measured with a Fitbit. Data on self-reported physical activity, screen time, fruit and vegetable intake, and sugary beverage intake of adolescents and parents were also collected. Results: A total of 214 parent-child participants were randomized. In our primary analyses, there were no significant differences in zBMI or any of the health behaviors between the intervention and control groups at 3 months. In our secondary analyses, among waitlist control participants, zBMI (P=.02), discretionary calories (P=.03), and physical activity outside of school (P=.001) declined, whereas daily screen time increased (P<.001) after receiving access to the app compared with before receiving app access. Adolescents randomized to Aim2Be with live coaching reported more time being active outside of school compared with adolescents who used Aim2Be with no coaching over 3 months (P=.001). App use did not modify any changes in outcomes among adolescents in the intervention group. Conclusions: The Aim2Be intervention did not improve zBMI and lifestyle behaviors in adolescents with overweight and obesity compared with the waitlist control group over 3 months. Future studies should explore the potential mediators of changes in zBMI and lifestyle behaviors as well as predictors of engagement. Trial Registration: ClinicalTrials.gov NCT03651284; https://clinicaltrials.gov/ct2/show/study/NCT03651284 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-020-4080-2 %M 37097726 %R 10.2196/38545 %U https://www.jmir.org/2023/1/e38545 %U https://doi.org/10.2196/38545 %U http://www.ncbi.nlm.nih.gov/pubmed/37097726 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 7 %N %P e44179 %T Cardio4Health Study, a Cardiac Telerehabilitation Pilot Program Aimed at Patients After an Ischemic Event: Cross-sectional Study %A Calvo-López,Margarita %A Arranz Tolós,Raquel %A Marin Expósito,Josefa %A Gruosso,Domenico %A Andrea,Rut %A Roque,Mercè %A Falces,Carles %A Yago,Gemma %A Saura Araguas,Judith %A Pastor,Nuria %A Sitges,Marta %A Sanz-de la Garza,Maria %+ Cardiovascular Clinical Institute, Hospital Clínic, C/Villaroel 170, Barcelona, 08036, Spain, 34 932275400, mcalvol@clinic.cat %K cardiac rehabilitation %K web-based platform %K telemedicine %K remote care %K ischemic heart disease %D 2023 %7 24.4.2023 %9 Original Paper %J JMIR Cardio %G English %X Background: Center-based cardiac rehabilitation programs (CRPs) reduce morbidity and mortality after an ischemic cardiac event; however, they are widely underused. Home-based CRP has emerged as an alternative to improve patient adherence; however, its safety and efficacy remain unclear, especially for older patients and female patients. Objective: This study aimed to develop a holistic home-based CRP for patients with ischemic heart disease and evaluate its safety and impact on functional capacity, adherence to a healthy lifestyle, and quality of life. Methods: The 8-week home-based CRP included patients of both sexes, with no age limit, who had overcome an acute myocardial infarction in the previous 3 months, had a left ventricular ejection fraction of ≥40%, and had access to a tablet or mobile device. The CRP was developed using a dedicated platform designed explicitly for this purpose and included 3 weekly exercise sessions combining tailored aerobic and strength training and 2 weekly educational session focused on lifestyle habits, therapeutic adherence, and patient empowerment. Results: We initially included 62 patients, of whom 1 was excluded for presenting with ventricular arrhythmias during the initial stress test, 5 were excluded because of incompatibility, and 6 dropped out because of a technological barrier. Ultimately, 50 patients completed the program: 85% (42/50) were male, with a mean age of 58.9 (SD 10.3) years, a mean left ventricular ejection fraction of 52.1% (SD 6.72%), and 25 (50%) New York Heart Association functional class I and 25 (50%) New York Heart Association II-III. The CRP significantly improved functional capacity (+1.6 metabolic equivalent tasks), muscle strength (arm curl test +15.5% and sit-to-stand test +19.7%), weekly training volume (+803 metabolic equivalent tasks), adherence to the Mediterranean diet, emotional state (anxiety), and quality of life. No major complications occurred, and adherence was excellent (>80%) in both the exercise and educational sessions. In the subgroup analysis, CRP showed equivalent beneficial effects irrespective of sex and age. In addition, patient preferences for CRP approaches were equally distributed, with one-third (14/50, 29%) of the patients preferring a face-to-face CRP, one-third (17/50, 34%) preferring a telematic CRP, and one-third (18/50, 37%) preferring a hybrid approach. Regarding CRP duration, 63% (31/50) of the patients considered it adequate, whereas the remaining 37% (19/50) preferred a longer program. Conclusions: A holistic telematic CRP dedicated to patients after an ischemic cardiac event, irrespective of sex and age, is safe and, in our population, has achieved positive results in improving maximal aerobic capacity, weekly training volume, muscle strength, quality of life, compliance with diet, and anxiety symptoms. The preference for a center- or home-based CRP approach is diverse among the study population, emphasizing the need for a tailored CRP to improve adherence and completion rates. %M 37093637 %R 10.2196/44179 %U https://cardio.jmir.org/2023/1/e44179 %U https://doi.org/10.2196/44179 %U http://www.ncbi.nlm.nih.gov/pubmed/37093637 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e36837 %T An App-Based Intervention for Pediatric Weight Management: Pre-Post Acceptability and Feasibility Trial %A Cox,Jennifer S %A Hinton,Elanor C %A Hamilton Shield,Julian %A Lawrence,Natalia S %+ NIHR Bristol Biomedical Research Centre Nutrition Theme, 3rd Floor, Education & Research Centre, Upper Maudlin Street, Bristol, BS2 8AE, United Kingdom, 44 07718905807, jennifer.cox@bristol.ac.uk %K obesity %K pediatric %K intervention %K eHealth %K weight management %D 2023 %7 24.4.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: A multidisciplinary approach to weight management is offered at tier 3 pediatric weight management services in the United Kingdom. Encouraging dietary change is a major aim, with patients meeting with dieticians, endocrinologists, psychologists, nurse specialists, and social workers on average every other month. Objective: This research sought to trial an inhibitory control training smartphone app—FoodT—with the clinic population of a pediatric weight management service. FoodT has shown positive impacts on food choice in adult users, with resulting weight loss. It was hoped that when delivered as an adjunctive treatment alongside the extensive social, medical, psychological, and dietetic interventions already offered at the clinic, the introduction of inhibitory control training may offer patients another tool that supports eating choice. In this feasibility trial, recruitment, retention, and app use were the primary outcomes. An extensive battery of measures was included to test the feasibility and acceptability of these measures for future powered trials. Methods: FoodT was offered to pediatric patients and their parents during a routine clinic appointment, and patients were asked to use the app at home every day for the first week and once per week for the rest of the month. Feasibility and acceptability were measured in terms of recruitment, engagement with the app, and retention to the trial. A battery of psychometric tests was given before and after app use to assess the acceptability of collecting data on changes to food choices and experiences that would inform future trial work. Results: A total of 12 children and 10 parents consented (22/62, 35% of those approached). Further, 1 child and no parents achieved the recommended training schedule. No participants completed the posttrial measures. The reasons for not wanting to be recruited to the trial included participants not considering their weight to be connected to eating choices and not feeling that the app suited their needs. No reasons are known for noncompletion. Conclusions: It is unclear whether the intervention itself or the research processes, including the battery of measures, prevented completion. It is therefore difficult to make any decisions as to the value that the app has within this setting. Important lessons have been learned from this research that have potential broad relevance, including the importance of co-designing interventions with service users and avoiding deterring people from early-stage participation in extensive data collection. %M 37093633 %R 10.2196/36837 %U https://formative.jmir.org/2023/1/e36837 %U https://doi.org/10.2196/36837 %U http://www.ncbi.nlm.nih.gov/pubmed/37093633 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43242 %T The Effectiveness of Smartphone App–Based Interventions for Assisting Smoking Cessation: Systematic Review and Meta-analysis %A Guo,Yi-Qiang %A Chen,Yuling %A Dabbs,Annette DeVito %A Wu,Ying %+ School of Nursing, Capital Medical University, 10 You-an-men Wai Xi-tou-tiao, Feng-tai District, Beijing, 100069, China, 86 10 8391 1766, helenywu@vip.163.com %K smartphone app %K smoking cessation %K meta-analysis %K eHealth %K mHealth %K smoking %K application %K intervention %K effectiveness %K electronic %K adult %K pharmacotherapy %D 2023 %7 20.4.2023 %9 Review %J J Med Internet Res %G English %X Background: Smoking is a leading cause of premature death globally. Quitting smoking reduces the risk of all-cause mortality by 11%-34%. Smartphone app–based smoking cessation (SASC) interventions have been developed and are widely used. However, the evidence for the effectiveness of smartphone-based interventions for smoking cessation is currently equivocal. Objective: The purpose of this study was to synthesize the evidence for the effectiveness of smartphone app–based interventions for smoking cessation. Methods: We conducted a systematic review and meta-analysis of the effectiveness of smartphone interventions for smoking cessation based on the Cochrane methodology. An electronic literature search was performed using the Cochrane Library, Web of Science, PubMed, Embase, PsycINFO, China National Knowledge Infrastructure, and Wanfang databases to identify published papers in English or Chinese (there was no time limit regarding the publication date). The outcome was the smoking abstinence rate, which was either a 7-day point prevalence abstinence rate or a continuous abstinence rate. Results: A total of 9 randomized controlled trials involving 12,967 adults were selected for the final analysis. The selected studies from 6 countries (the United States, Spain, France, Switzerland, Canada, and Japan) were included in the meta-analysis between 2018 and 2022. Pooled effect sizes (across all follow-up time points) revealed no difference between the smartphone app group and the comparators (standard care, SMS text messaging intervention, web-based intervention, smoking cessation counseling, or apps as placebos without real function; odds ratio [OR] 1.25, 95% CI 0.99-1.56, P=.06, I2=73.6%). Based on the subanalyses, 6 trials comparing smartphone app interventions to comparator interventions reported no significant differences in effectiveness (OR 1.03, 95% CI 0.85-1.26, P=.74, I2=57.1%). However, the 3 trials that evaluated the combination of smartphone interventions combined with pharmacotherapy compared to pharmacotherapy alone found higher smoking abstinence rates in the combined intervention (OR 1.79, 95% CI 1.38-2.33, P=.74, I2=7.4%). All SASC interventions with higher levels of adherence were significantly more effective (OR 1.48, 95% CI 1.20-1.84, P<.001, I2=24.5%). Conclusions: This systematic review and meta-analysis did not support the effectiveness of delivering smartphone-based interventions alone to achieve higher smoking abstinence rates. However, the efficacy of smartphone-based interventions increased when combined with pharmacotherapy-based smoking cessation approaches. Trial Registration: PROSPERO CRD42021267615; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=267615 %M 37079352 %R 10.2196/43242 %U https://www.jmir.org/2023/1/e43242 %U https://doi.org/10.2196/43242 %U http://www.ncbi.nlm.nih.gov/pubmed/37079352 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e41712 %T Examination of the Feasibility, Acceptability, and Efficacy of the Online Personalised Training in Memory Strategies for Everyday Program for Older Adults: Single-Arm Pre-Post Trial %A Pike,Kerryn %A Moller,Carl I %A Bryant,Christina %A Farrow,Maree %A Dao,Duy P %A Ellis,Kathryn A %+ School of Applied Psychology, Griffith Centre for Mental Health & Menzies Health Institute Queensland, Griffith University, Parklands Drive, Southport, Gold Coast, 4222, Australia, 61 756788606, k.pike@griffith.edu.au %K cognition %K learning %K internet-based intervention %K social support %K subjective cognitive decline %K mobile phone %D 2023 %7 20.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Memory strategy training for older adults helps maintain and improve cognitive health but is traditionally offered face-to-face, which is resource intensive, limits accessibility, and is challenging during a pandemic. Web-based interventions, such as the Online Personalised Training in Memory Strategies for Everyday (OPTIMiSE) program, may overcome such barriers. Objective: We report on OPTIMiSE’s feasibility, acceptability, and efficacy. Methods: Australians aged ≥60 years reporting subjective cognitive decline participated in this single-arm pre-post web-based intervention. OPTIMiSE is a 6-module web-based program offered over 8-weeks with a 3-month booster. It has a problem-solving approach to memory issues, focusing on psychoeducation about memory and aging, knowledge and practice of compensatory memory strategies, and personalized content related to individual priorities. We examined the feasibility (recruitment, attrition, and data collection), acceptability (recommendation to others, suggestions for improvement, and withdrawal reasons), and efficacy (change in goal satisfaction, strategy knowledge and use, self-reported memory, memory satisfaction and knowledge, and mood; thematic content analysis of the most significant change; and the application of knowledge and strategies in daily life) of OPTIMiSE. Results: OPTIMiSE was feasible, demonstrated by strong interest (633 individuals screened), a satisfactory level of attrition (158/312, 50.6%), and minimal missing data from those completing the intervention. It was acceptable, with 97.4% (150/154) of participants agreeing they would recommend OPTIMiSE, the main suggestion for improvement being more time to complete modules, and withdrawal reasons similar to those in in-person interventions. OPTIMiSE was also efficacious, with linear mixed-effects analyses revealing improvements, of moderate to large effect sizes, across all primary outcomes (all P<.001): memory goal satisfaction (Cohen d after course=1.24; Cohen d at 3-month booster=1.64), strategy knowledge (Cohen d after course=0.67; Cohen d at 3-month booster=0.72) and use (Cohen d after course=0.79; Cohen d at 3-month booster=0.90), self-reported memory (Cohen d after course=0.80; Cohen d at 3-month booster=0.83), memory satisfaction (Cohen d after course=1.25; Cohen d at 3-month booster=1.29) and knowledge (Cohen d after course=0.96; Cohen d at 3-month booster=0.26), and mood (Cohen d after course=−0.35; nonsignificant Cohen d at booster). Furthermore, the most significant changes reported by participants (strategy use, improvements in daily life, reduced concern about memory, confidence and self-efficacy, and sharing and shame busting with others) reflected the course objectives and were consistent with themes arising from previous in-person interventions. At the 3-month booster, many participants reported continued implementation of knowledge and strategies in their daily lives. Conclusions: This feasible, acceptable, and efficacious web-based program has the potential to enable access to evidence-based memory interventions for older adults worldwide. Notably, the changes in knowledge, beliefs, and strategy use continued beyond the initial program. This is particularly important for supporting the growing number of older adults living with cognitive concerns. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620000979954; https://tinyurl.com/34cdantv International Registered Report Identifier (IRRID): RR2-10.3233/ADR-200251 %M 37079356 %R 10.2196/41712 %U https://www.jmir.org/2023/1/e41712 %U https://doi.org/10.2196/41712 %U http://www.ncbi.nlm.nih.gov/pubmed/37079356 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e38307 %T Effectiveness of eHealth Interventions Targeting Employee Health Behaviors: Systematic Review %A Sevic,Aleksandra %A Hashemi,Neda S %A Thørrisen,Mikkel Magnus %A Strømstad,Kine %A Skarpaas,Lisebet Skeie %A Storm,Marianne %A Brønnick,Kolbjørn Kallesten %+ Department of Public Health, Faculty of Health Sciences, University of Stavanger, Hagbard Lines hus, Telegrafdirektør Heftyes vei 35, Stavanger, 4021, Norway, 47 45781149, aleksandra.sevic@uis.no %K eHealth %K employees %K workplace %K health behaviors %K sickness absence %K behavior change techniques %K systematic review %K mobile phone %D 2023 %7 20.4.2023 %9 Review %J J Med Internet Res %G English %X Background: The number of people with noncommunicable diseases is increasing. Noncommunicable diseases are the major cause of disability and premature mortality worldwide, associated with negative workplace outcomes such as sickness absence and reduced work productivity. There is a need to identify scalable interventions and their active components to relieve disease and treatment burden and facilitate work participation. eHealth interventions have shown potential in clinical and general populations to increase well-being and physical activity and could be well suited for workplace settings. Objective: We aimed to provide an overview of the effectiveness of eHealth interventions at the workplace targeting employee health behaviors and map behavior change techniques (BCTs) used in these interventions. Methods: A systematic literature search was performed in PubMed, Embase, PsycINFO, Cochrane CENTRAL, and CINAHL in September 2020 and updated in September 2021. Extracted data included participant characteristics, setting, eHealth intervention type, mode of delivery, reported outcomes, effect sizes, and attrition rates. Quality and risk of bias of the included studies were assessed using the Cochrane Collaboration risk-of-bias 2 tool. BCTs were mapped in accordance with the BCT Taxonomy v1. The review was reported according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) checklist. Results: In total, 17 randomized controlled trials met the inclusion criteria. The measured outcomes, treatment and follow-up periods, content of eHealth interventions, and workplace contexts had high heterogeneity. Of the 17 studies, 4 (24%) reported unequivocally significant findings for all primary outcomes, with effect sizes ranging from small to large. Furthermore, 53% (9/17) of the studies reported mixed results, and 24% (4/17) reported nonsignificant results. The most frequently targeted behavior was physical activity (15/17, 88% of the studies); the least frequently targeted behavior was smoking (2/17, 12% of the studies). Attrition varied greatly across the studies (0%-37%). Risk of bias was high in 65% (11/17) of the studies, with some concerns in the remaining 35% (6/17). Interventions used various BCTs, and the most frequently used were feedback and monitoring (14/17, 82%), goals and planning (10/17, 59%), antecedents (10/17, 59%), and social support (7/17, 41%). Conclusions: This review suggests that, although eHealth interventions may have potential, there are still unanswered questions regarding their effectiveness and what drives the mechanism behind these effects. Low methodological quality, high heterogeneity and complexity, the characteristics of the included samples, and often high attrition rates challenge the investigation of the effectiveness and the making of sound inferences about the effect sizes and significance of the results. To address this, new studies and methods are needed. A megastudy design in which different interventions are evaluated in the same population over the same period on the same outcomes may solve some of the challenges. Trial Registration: PROSPERO CRD42020202777; https://www-crd-york-ac-uk/prospero/display_record.php?RecordID=202777 %M 37079369 %R 10.2196/38307 %U https://www.jmir.org/2023/1/e38307 %U https://doi.org/10.2196/38307 %U http://www.ncbi.nlm.nih.gov/pubmed/37079369 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e43164 %T Mobile Acceptance and Commitment Therapy in Bipolar Disorder: Microrandomized Trial %A Cochran,Amy %A Maronge,Jacob M %A Victory,Amanda %A Hoel,Sydney %A McInnis,Melvin G %A Thomas,Emily BK %+ Department of Population Health Sciences, University of Wisconsin Madison, 610 Walnut Street, Madison, WI, 53726, United States, 1 608 262 0772, cochran4@wisc.edu %K acceptance and commitment therapy %K bipolar disorder %K mobile applications %K randomized controlled trials %K micro-randomized trial %K precision medicine %K mindfulness %D 2023 %7 20.4.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Mobile interventions promise to fill in gaps in care with their broad reach and flexible delivery. Objective: Our goal was to investigate delivery of a mobile version of acceptance and commitment therapy (ACT) for individuals with bipolar disorder (BP). Methods: Individuals with BP (n=30) participated in a 6-week microrandomized trial. Twice daily, participants logged symptoms in the app and were repeatedly randomized (or not) to receive an ACT intervention. Self-reported behavior and mood were measured as the energy devoted to moving toward valued domains or away from difficult emotions and with depressive d and manic m scores from the digital survey of mood in BP survey (digiBP). Results: Participants completed an average of 66% of in-app assessments. Interventions did not significantly impact the average toward energy or away energy but did significantly increase the average manic score m (P=.008) and depressive score d (P=.02). This was driven by increased fidgeting and irritability and interventions focused on increasing awareness of internal experiences. Conclusions: The findings of the study do not support a larger study on the mobile ACT in BP but have significant implications for future studies seeking mobile therapy for individuals with BP. Trial Registration: ClinicalTrials.gov NCT04098497; https://clinicaltrials.gov/ct2/show/NCT04098497 %M 37079363 %R 10.2196/43164 %U https://mental.jmir.org/2023/1/e43164 %U https://doi.org/10.2196/43164 %U http://www.ncbi.nlm.nih.gov/pubmed/37079363 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e42316 %T Suicide Prevention Using Google Ads: Randomized Controlled Trial Measuring Engagement %A Onie,Sandersan %A Berlinquette,Patrick %A Holland,Sarah %A Livingstone,Nicola %A Finemore,Coco %A Gale,Nyree %A Elder,Emma %A Laggis,George %A Heffernan,Cassandra %A Armstrong,Susanne Oliver %A Theobald,Adam %A Josifovski,Natasha %A Torok,Michelle %A Shand,Fiona %A Larsen,Mark %+ Black Dog Institute, 1 Hospital Rd, Randwick, 2031, Australia, 61 (02) 9382 4530, s.onie@blackdog.org.au %K suicide prevention %K suicide %K suicidal %K self harm %K digital advertising %K Google Ads %K search %K suicide hotline %K advertise %K advertising %K campaign %K mental health %K prevention %K digital intervention %K online intervention %D 2023 %7 20.4.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Studies have shown that individuals may search for suicide-related terms on the internet prior to an attempt. Objective: Thus, across 2 studies, we investigated engagement with an advertisement campaign designed to reach individuals contemplating suicide. Methods: First, we designed the campaign to focus on crisis, running a campaign for 16 days in which crisis-related keywords would trigger an ad and landing page to help individuals find the national suicide hotline number. Second, we expanded the campaign to also help individuals contemplating suicide, running the campaign for 19 days with a wider range of keywords through a co-designed website with a wider range of offerings (eg, lived experience stories). Results: In the first study, the ad was shown 16,505 times and was clicked 664 times (4.02% click rate). There were 101 calls to the hotline. In the second study, the ad was shown 120,881 times and clicked 6227 times (5.15% click rate); of these 6227 clicks, there were 1419 (22.79%) engagements with the site, a substantially higher rate than the industry average of 3%. The number of clicks on the ad was high despite a suicide hotline banner likely being present. Conclusions: Search advertisements are a quick, far-reaching, and cost-efficient way of reaching those contemplating suicide and are needed despite suicide hotline banners being present. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12623000084684; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385209 %M 37079348 %R 10.2196/42316 %U https://mental.jmir.org/2023/1/e42316 %U https://doi.org/10.2196/42316 %U http://www.ncbi.nlm.nih.gov/pubmed/37079348 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 9 %N %P e44695 %T Exploring Cancer Incidence, Risk Factors, and Mortality in the Lleida Region: Interactive, Open-source R Shiny Application for Cancer Data Analysis %A Florensa,Didac %A Mateo-Fornes,Jordi %A Lopez Sorribes,Sergi %A Torres Tuca,Anna %A Solsona,Francesc %A Godoy,Pere %+ Department of Computer Engineering, University of Lleida, C/ Jaume II, 69, Lleida, 25002, Spain, 34 603534021, didac.florensa@gencat.cat %K R Shiny %K cloud computing %K microservices %K Docker %K decision support system %K cancer incidence %K cancer risk factors, cancer mortality %D 2023 %7 20.4.2023 %9 Original Paper %J JMIR Cancer %G English %X Background: The cancer incidence rate is essential to public health surveillance. The analysis of this information allows authorities to know the cancer situation in their regions, especially to determine cancer patterns, monitor cancer trends, and help prioritize the allocation of health resource. Objective: This study aimed to present the design and implementation of an R Shiny application to assist cancer registries conduct rapid descriptive and predictive analytics in a user-friendly, intuitive, portable, and scalable way. Moreover, we wanted to describe the design and implementation road map to inspire other population registries to exploit their data sets and develop similar tools and models. Methods: The first step was to consolidate the data into the population registry cancer database. These data were cross validated by ASEDAT software, checked later, and reviewed by experts. Next, we developed an online tool to visualize the data and generate reports to assist decision-making under the R Shiny framework. Currently, the application can generate descriptive analytics using population variables, such as age, sex, and cancer type; cancer incidence in region-level geographical heat maps; line plots to visualize temporal trends; and typical risk factor plots. The application also showed descriptive plots about cancer mortality in the Lleida region. This web platform was built as a microservices cloud platform. The web back end consists of an application programming interface and a database, which NodeJS and MongoDB have implemented. All these parts were encapsulated and deployed by Docker and Docker Compose. Results: The results provide a successful case study in which the tool was applied to the cancer registry of the Lleida region. The study illustrates how researchers and cancer registries can use the application to analyze cancer databases. Furthermore, the results highlight the analytics related to risk factors, second tumors, and cancer mortality. The application shows the incidence and evolution of each cancer during a specific period for gender, age groups, and cancer location, among other functionalities. The risk factors view permitted us to detect that approximately 60% of cancer patients were diagnosed with excess weight at diagnosis. Regarding mortality, the application showed that lung cancer registered the highest number of deaths for both genders. Breast cancer was the lethal cancer in women. Finally, a customization guide was included as a result of this implementation to deploy the architecture presented. Conclusions: This paper aimed to document a successful methodology for exploiting the data in population cancer registries and propose guidelines for other similar records to develop similar tools. We intend to inspire other entities to build an application that can help decision-making and make data more accessible and transparent for the community of users. %M 37079353 %R 10.2196/44695 %U https://cancer.jmir.org/2023/1/e44695 %U https://doi.org/10.2196/44695 %U http://www.ncbi.nlm.nih.gov/pubmed/37079353 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 6 %N %P e40762 %T Usability of a Community-Based Dementia Resource Website: Mixed Methods Study %A Thomas,Missy %A Henderson,Dean %A Trudel,Chantal %A Thomas,Neil %+ Bruyère Research Institute, 43 Bruyère Street, Ottawa, ON, K1N 5C8, Canada, 1 1 613 562 6262 ext 4071, nthomas@bruyere.org %K dementia %K caregivers %K eHealth %K community resources %D 2023 %7 20.4.2023 %9 Original Paper %J JMIR Aging %G English %X Background: Many individuals living with dementia want to live in their own homes for as long as possible. To do so, they frequently require assistance with activities of daily living, which is often provided by friends and relatives acting as informal care partners. In Canada, many informal care partners are currently overworked and overwhelmed. Although community-based dementia-inclusive resources are available to support them, care partners often struggle to find them. Dementia613.ca was created to make the process of finding community dementia-inclusive resources simpler and more straightforward by bringing them together in one eHealth website. Objective: The objective of our study was to determine if dementia613.ca is meeting the goal of connecting care partners and persons living with dementia to dementia-inclusive resources in their community. Methods: A review and assessment of the website was conducted using 3 evaluation methods: web analytics, questionnaires, and task analysis. Google Analytics was used to collect data related to website use over a 9-month period. Data on site content and user characteristics were collected. Furthermore, 2 web-based self-administered questionnaires were developed: one intended for care partners and persons living with dementia, and the other intended for businesses and organizations interested in serving persons living with dementia. Both gathered data on user characteristics and included standard questions used in website evaluations. Responses were collected over a 6-month period. Scenarios, tasks, and questions were developed for the moderated, remote, and task-analysis sessions. These tasks and questions determined how effectively persons living with dementia and their care partners can use dementia613.ca. Overall, 5 sessions were held with persons experiencing moderate cognitive decline and with care partners of persons living with dementia. Results: This evaluation showed that the idea behind dementia613.ca is strong and appeals to persons living with dementia, their care partners, and the businesses and organizations serving this market. Participants indicated that it is a useful community resource that meets a previously unfulfilled need in the area, and highlighted the benefits of bringing community resources together on 1 website. In our questionnaire, >60% (19/29, 66%) of people living with dementia and their care partners and 70% (7/10) of businesses and organizations agreed that the website made it easier to find relevant dementia-inclusive resources. There is room for improvement; participants indicated that the navigation and search features could be further developed. Conclusions: We believe that the dementia613.ca model could be used to inspire and guide the creation of dementia resource websites in other regions in Ontario and beyond. The framework behind it is generalizable and could be replicated to help care partners and persons living with dementia find local resources more easily. %M 37079355 %R 10.2196/40762 %U https://aging.jmir.org/2023/1/e40762 %U https://doi.org/10.2196/40762 %U http://www.ncbi.nlm.nih.gov/pubmed/37079355 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45305 %T The Impact of Family Therapy Participation on Youths and Young Adult Engagement and Retention in a Telehealth Intensive Outpatient Program: Quality Improvement Analysis %A Berry,Katie R %A Gliske,Kate %A Schmidt,Clare %A Ballard,Jaime %A Killian,Michael %A Fenkel,Caroline %+ Charlie Health, Inc, 233 E Main St Suite 401, Bozeman, MT, 59715, United States, 1 9545527671, krberry@fsu.edu %K adolescents %K family therapy %K intensive outpatient %K mental health %K treatment engagement %K young adults %D 2023 %7 20.4.2023 %9 Original Paper %J JMIR Form Res %G English %X Background:  Early treatment dropout among youths and young adults (28%-75%) puts them at risk for poorer outcomes. Family engagement in treatment is linked to lower dropout and better attendance in outpatient, in-person treatment. However, this has not been studied in intensive or telehealth settings. Objective:  We aimed to examine whether family members’ participation in telehealth intensive outpatient (IOP) therapy for mental health disorders in youths and young adults is associated with patient’s treatment engagement. A secondary aim was to assess demographic factors associated with family engagement in treatment. Methods:  Data were collected from intake surveys, discharge outcome surveys, and administrative data for patients who attended a remote IOP for youths and young adults, nationwide. Data included 1487 patients who completed both intake and discharge surveys and either completed or disengaged from treatment between December 2020 and September 2022. Descriptive statistics were used to characterize the sample’s baseline differences in demographics, engagement, and participation in family therapy. Mann-Whitney U and chi-square tests were used to explore differences in engagement and treatment completion between patients with and those without family therapy. Binomial regression was used to explore significant demographic predictors of family therapy participation and treatment completion. Results:  Patients with family therapy had significantly better engagement and treatment completion outcomes than clients with no family therapy. Youths and young adults with ≥1 family therapy session were significantly more likely to stay in treatment an average of 2 weeks longer (median 11 weeks vs 9 weeks) and to attend a higher percentage of IOP sessions (median 84.38% vs 75.00%). Patients with family therapy were more likely to complete treatment than clients with no family therapy (608/731, 83.2% vs 445/752, 59.2%; P<.001). Different demographic variables were associated with an increased likelihood of participating in family therapy, including younger age (odds ratio 1.3) and identifying as heterosexual (odds ratio 1.4). After controlling for demographic factors, family therapy remained a significant predictor of treatment completion, such that each family therapy session attended was associated with a 1.4-fold increase in the odds of completing treatment (95% CI 1.3-1.4). Conclusions:  Youths and young adults whose families participate in any family therapy have lower dropout, greater length of stay, and higher treatment completion than those whose families do not participate in services in a remote IOP program. The findings of this quality improvement analysis are the first to establish a relationship between participation in family therapy and an increased engagement and retention in remote treatment for youths and young patients in IOP programing. Given the established importance of obtaining an adequate dosage of treatment, bolstering family therapy offerings is another tool that could contribute to the provision of care that better meets the needs of youths, young adults, and their families. %M 37079372 %R 10.2196/45305 %U https://formative.jmir.org/2023/1/e45305 %U https://doi.org/10.2196/45305 %U http://www.ncbi.nlm.nih.gov/pubmed/37079372 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e40359 %T Learning in a Virtual Environment to Improve Type 2 Diabetes Outcomes: Randomized Controlled Trial %A Johnson,Constance M %A D'Eramo Melkus,Gail %A Reagan,Louise %A Pan,Wei %A Amarasekara,Sathya %A Pereira,Katherine %A Hassell,Nancy %A Nowlin,Sarah %A Vorderstrasse,Allison %+ Cizik School of Nursing, University of Texas Health Science Center at Houston, 6901 Bertner Ave, SON 539, Houston, TX, 77030, United States, 1 7135009936, constance.m.johnson@uth.tmc.edu %K eHealth %K randomized controlled trial %K self-management %K type 2 diabetes mellitus %K computer-mediated environments %K virtual environment %D 2023 %7 20.4.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Given the importance of self-management in type 2 diabetes mellitus (T2DM), a major aspect of health is providing diabetes self-management education and support. Known barriers include access, availability, and the lack of follow through on referral to education programs. Virtual education and support have increased in use over the last few years. Objective: The purpose of the Diabetes Learning in a Virtual Environment (LIVE) study was to compare the effects of the LIVE intervention (educational 3D world) to a diabetes self-management education and support control website on diet and physical activity behaviors and behavioral and metabolic outcomes in adults with T2DM over 12 months. Methods: The LIVE study was a 52-week multisite randomized controlled trial with longitudinal repeated measures. Participants were randomized to LIVE (n=102) or a control website (n=109). Both contained the same educational materials, but the virtual environment was synchronous and interactive, whereas the control was a flat website. Data were collected at baseline and 3, 6, and 12 months using surveys and clinical, laboratory, and Fitbit measures. Descriptive statistics included baseline characteristics and demographics. The effects of the intervention were initially examined by comparing the means and SDs of the outcomes across the 4 time points between study arms, followed by multilevel modeling on trajectories of the outcomes over the 12 months. Results: This trial included 211 participants who consented. The mean age was 58.85 (SD 10.1) years, and a majority were White (127/211, 60.2%), non-Hispanic (198/211, 93.8%), married (107/190, 56.3%), and female (125/211, 59.2%). Mean hemoglobin A1c (HbA1c) level at baseline was 7.64% (SD 1.79%) and mean BMI was 33.51 (SD 7.25). We examined weight loss status versus randomized group, where data with no weight change were eliminated, and the LIVE group experienced significantly more weight loss than the control group (P=.04). There were no significant differences between groups in changes in physical activity and dietary outcomes (all P>.05), but each group showed an increase in physical activity. Both groups experienced a decrease in mean HbA1c level, systolic and diastolic blood pressure, cholesterol, and triglycerides over the course of 12 months of study participation, including those participants whose baseline HbA1c level was 8.6% or higher. Conclusions: This study confirmed that there were minor positive changes on glycemic targets in both groups over the 12-month study period; however, the majority of the participants began with optimal HbA1c levels. We did find clinically relevant metabolic changes in those who began with an HbA1c level >8.6% in both groups. This study provided a variety of resources to our participants in both study groups, and we conclude that a toolkit with a variety of services would be helpful to improving self-care in the future for persons with T2DM. Trial Registration: ClinicalTrials.gov NCT02040038; https://clinicaltrials.gov/ct2/show/NCT02040038 %M 36962700 %R 10.2196/40359 %U https://formative.jmir.org/2023/1/e40359 %U https://doi.org/10.2196/40359 %U http://www.ncbi.nlm.nih.gov/pubmed/36962700 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e41900 %T Addressing Preconception Behavior Change Through Mobile Phone Apps: Systematic Review and Meta-analysis %A Musgrave,Loretta %A Cheney,Kate %A Dorney,Edwina %A Homer,Caroline S E %A Gordon,Adrienne %+ Centre for Midwifery, Child and Family Health, University of Technology Sydney, 235 Jones St, NSW, Sydney, 2007, Australia, 61 9514 5069, loretta.musgrave@uts.edu.au %K apps %K mobile %K preconception %K prenatal care %K perinatal %K reproductive health %K reproductive age %K maternal %K interconception %K behavior change %K mobile phone %D 2023 %7 19.4.2023 %9 Review %J J Med Internet Res %G English %X Background: Positive health behavior changes before pregnancy can optimize perinatal outcomes for mothers, babies, and future generations. Women are often motivated to positively change their behavior in preparation for pregnancy to enhance their health and well-being. Mobile phone apps may provide an opportunity to deliver public health interventions during the preconception period. Objective: This review aimed to synthesize the evidence of the effectiveness of mobile phone apps in promoting positive behavior changes in women of reproductive age before they are pregnant (preconception and interconception periods), which may improve future outcomes for mothers and babies. Methods: Five databases were searched in February 2022 for studies exploring mobile phone apps as a prepregnancy intervention to promote positive behavior change. The identified studies were retrieved and exported to EndNote (Thomson Reuters). Using Covidence (Veritas Health Innovation), a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) study flow diagram was generated to map the number of records identified, included, and excluded. Three independent reviewers assessed the risk of bias and conducted data extraction using the Review Manager software (version 5.4, The Cochrane Collaboration), and the data were then pooled using a random-effects model. The Grades of Recommendation, Assessment, Development, and Evaluation system was used to assess the certainty of the evidence. Results: Of the 2973 publications identified, 7 (0.24%) were included. The total number of participants across the 7 trials was 3161. Of the 7 studies, 4 (57%) included participants in the interconception period, and 3 (43%) included women in the preconception period. Of the 7 studies, 5 (71%) studies focused on weight reduction, assessing the outcomes of reductions in adiposity and weight. Of the 7 studies, nutrition and dietary outcomes were evaluated in 2 (29%) studies, blood pressure outcomes were compared in 4 (57%) studies, and biochemical and marker outcomes associated with managing disease symptoms were included in 4 (57%) studies. Analysis showed that there were no statistically significant differences in energy intake; weight loss; body fat; and biomarkers such as glycated hemoglobin, total cholesterol, fasting lipid profiles, or blood pressure when compared with standard care. Conclusions: Owing to the limited number of studies and low certainty of the evidence, no firm conclusions can be drawn on the effects of mobile phone app interventions on promoting positive behavior changes in women of reproductive age before they are pregnant (preconception and interconception periods). Trial Registration: PROSPERO CRD42017065903; https://tinyurl.com/2p9dwk4a International Registered Report Identifier (IRRID): RR2-10.1186/s13643-019-0996-6 %M 37074767 %R 10.2196/41900 %U https://www.jmir.org/2023/1/e41900 %U https://doi.org/10.2196/41900 %U http://www.ncbi.nlm.nih.gov/pubmed/37074767 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e41021 %T Feasibility and Response to the San Diego County, California, Supplemental Nutrition Assistance Program (SNAP) Agency Sending Food and Nutrition Text Messages to All Participants: Quasi-Experimental Web-Based Survey Pilot Study %A Gosliner,Wendi %A Felix,Celeste %A Strochlic,Ron %A Wright,Shana %A Yates-Berg,Allison %A Thompson,Hannah R %A Tang,Hao %A Melendrez,Blanca %+ Nutrition Policy Institute, Division of Agriculture and Natural Resources, University of California, 1111 Franklin St, 11th Fl, Oakland, CA, 94607, United States, 1 510 612 1552, wgosliner@ucanr.edu %K SNAP %K CalFresh %K text %K SMS text messaging %K nutrition %K fruits %K vegetables %K mHealth %D 2023 %7 19.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: The Supplemental Nutrition Assistance Program (SNAP) provides over 40 million Americans with money for food without typically providing participants with food or nutrition information. Educational SMS text messages can reach large numbers of people, and studies suggest SNAP participants appreciate nutrition education and have access to mobile phones. Objective: Using a pre-post intervention design, we assessed the feasibility of, and program satisfaction and outcomes resulting from, the San Diego County, California SNAP agency sending monthly food and nutrition education SMS text messages to all SNAP participants to increase fruit and vegetable purchasing and consumption. Methods: We developed and sent 5 behavioral science–informed SMS text messages with links to a project website in English and Spanish with information about selecting, storing, and preparing seasonal fruits and vegetables. The San Diego County SNAP agency sent monthly texts to ~170,000 SNAP households from October 2020 to February 2021. SNAP participants completed web-based surveys in response to a text invitation from the SNAP agency in September 2020 (baseline, n=12,036) and April 2021 (follow-up, n=4927). Descriptive frequencies were generated, and adjusted multiple linear mixed models were run on a matched data set of participants that completed both baseline and follow-up surveys (n=875) assessing pre- or postattitudes, behaviors, knowledge, and self-efficacy. We used adjusted logistic regression models to assess differences between the matched (n=875) and nonmatched (n=4052) participants related to experiences with the intervention (questions asked only at follow-up). Results: After the intervention, matched participants reported significant increase in knowing where to get information about selecting, storing, and preparing fruits and vegetables (3.76 vs 4.02 on a 5-point Likert scale with 5=strongly agree, P<.001); feeling good about participating in SNAP (4.35 vs 4.43, P=.03); and thinking the CalFresh program helps them eat healthy (4.38 vs 4.48, P=.006). No significant pre- or postdifferences were found in fruit or vegetable consumption, though most participants at follow-up (n=1556, 64%) reported their consumption had increased. Among the sample that completed the follow-up survey only (n=4052, not including 875 participants who completed follow-up and baseline), 1583 (65%) and 1556 (64%) reported purchasing and eating more California-grown fruits and vegetables, respectively. Nearly all respondents appreciated the intervention (n=2203, 90%) and wanted it to continue (n=2037, 83%). Conclusions: SNAP can feasibly provide food and nutrition messages via text to participants. A monthly text campaign was well received by responding participants and improved some measures of their self-reported knowledge, self-efficacy, produce consumption, and perceptions of SNAP participation. Participants expressed interest in continuing to receive texts. While educational messages will not solve the complex food and nutrition challenges confronting SNAP participants, further work should employ rigorous methods to expand and test this intervention in other SNAP programs before considering to implement it at scale. %M 37074786 %R 10.2196/41021 %U https://www.jmir.org/2023/1/e41021 %U https://doi.org/10.2196/41021 %U http://www.ncbi.nlm.nih.gov/pubmed/37074786 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e43956 %T A Digital Peer Support Platform to Translate Online Peer Support for Emerging Adult Mental Well-being: Randomized Controlled Trial %A Yeo,GeckHong %A Loo,Gladys %A Oon,Matt %A Pang,Rachel %A Ho,Dean %+ N.1 Institute for Health, National University of Singapore, 28 Medical Drive, Singapore, 117456, Singapore, 65 6601 7766, geckhongyeo@gmail.com %K mental health %K digital health %K peer support intervention %K peer emotional disclosure %K randomized controlled trial %D 2023 %7 18.4.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Emerging adulthood (ages 19 to 25 years) is a developmental phase that is marked by increased mental health conditions, especially depression and anxiety. A growing body of work indicates that digital peer emotional support has positive implications for the psychological functioning of emerging adults. There is burgeoning interest among health care professionals, educational stakeholders, and policy makers in understanding the implementation and clinical effectiveness, as well as the associated mechanism of change, of digital peer support as an intervention. Objective: This randomized controlled trial (RCT) examined the effectiveness of a digital peer support intervention over a digital platform—Acceset—for emerging adult psychological well-being with 3 primary aims. First, we evaluated the implementation effectiveness of digital peer support training for individuals providing support (befrienders) and of the digital platform for peer support. Second, we assessed the clinical outcomes of digital peer support in terms of the intervening effect on emerging adult psychological well-being. Third, we investigated the mechanism of change linking the digital peer support intervention to emerging adult psychological well-being. Methods: This RCT involving 100 emerging adults from the National University of Singapore follows the published protocol for this trial. Results: This RCT found effectiveness in digital peer support training—specifically, befrienders’ peer support responses demonstrating significantly higher post- than pretraining scores in selfhood (posttraining score: mean 62.83, SD 10.18, and SE 1.72; pretraining score: mean 54.86, SD 7.32, and SE 1.24; t34=3.88; P<.001). The digital peer support intervention demonstrated clinical effectiveness in enhancing selfhood, compassion, and mindfulness and lowering depressive and anxiety symptoms among seekers in the intervention group after the intervention (mean 7.15, SD 5.14; SE 0.88) than among seekers in the waitlist control group before the intervention (mean 11.75, SD 6.72; SE 0.89; t89=3.44; P<.001). The effect of the intervention on seekers’ psychological well-being was sustained beyond the period of the intervention. The mechanism of change revealed that seekers’ engagement with the intervention had both immediate and prospective implications for their psychological well-being. Conclusions: This RCT of a digital peer support intervention for emerging adult psychological well-being harnesses the interventional potential of 4 components of psychological well-being and elucidated a mechanism of change. By incorporating and validating the digital features and process of a peer support platform, our RCT provides the parameters and conditions for deploying an effective and novel digital peer support intervention for emerging adult psychological well-being in real-world settings. Trial Registration: ClinicalTrials.gov NCT05083676; https://clinicaltrials.gov/ct2/show/NCT05083676 %M 36756843 %R 10.2196/43956 %U https://mental.jmir.org/2023/1/e43956 %U https://doi.org/10.2196/43956 %U http://www.ncbi.nlm.nih.gov/pubmed/36756843 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e45711 %T Digital Interventions for Treating Post-COVID or Long-COVID Symptoms: Scoping Review %A Rinn,Robin %A Gao,Lingling %A Schoeneich,Sarah %A Dahmen,Alina %A Anand Kumar,Vinayak %A Becker,Petra %A Lippke,Sonia %+ Constructor University, Campus Ring 1, Bremen, 28759, Germany, 49 4212004730, rrinn@constructor.university %K post-COVID/long-COVID symptom recovery %K postacute COVID-19 symptoms %K treatment %K therapy %K mHealth %K mobile health %K rehabilitation %K COVID-19 %D 2023 %7 17.4.2023 %9 Review %J J Med Internet Res %G English %X Background: Patients with post-COVID/long-COVID symptoms need support, and health care professionals need to be able to provide evidence-based patient care. Digital interventions can meet these requirements, especially if personal contact is limited. Objective: We reviewed evidence-based digital interventions that are currently available to help manage physical and mental health in patients with post-COVID/long-COVID symptoms. Methods: A scoping review was carried out summarizing novel digital health interventions for treating post-COVID/long-COVID patients. Using the PICO (population, intervention, comparison, outcome) scheme, original studies were summarized, in which patients with post-COVID/long-COVID symptoms used digital interventions to help aid recovery. Results: From all scanned articles, 8 original studies matched the inclusion criteria. Of the 8 studies, 3 were “pretest” studies, 3 described the implementation of a telerehabilitation program, 1 was a post-COVID/long-COVID program, and 1 described the results of qualitative interviews with patients who used an online peer-support group. Following the PICO scheme, we summarized previous studies. Studies varied in terms of participants (P), ranging from adults in different countries, such as former hospitalized patients with COVID-19, to individuals in disadvantaged communities in the United Kingdom, as well as health care workers. In addition, the studies included patients who had previously been infected with COVID-19 and who had ongoing symptoms. Some studies focused on individuals with specific symptoms, including those with either post–COVID-19 or long-term symptoms, while other studies included patients based on participation in online peer-support groups. The interventions (I) also varied. Most interventions used a combination of psychological and physical exercises, but they varied in duration, frequency, and social dimensions. The reviewed studies investigated the physical and mental health conditions of patients with post-COVID/long-COVID symptoms. Most studies had no control (C) group, and most studies reported outcomes (O) or improvements in physiological health perception, some physical conditions, fatigue, and some psychological aspects such as depression. However, some studies found no improvements in bowel or bladder problems, concentration, short-term memory, unpleasant dreams, physical ailments, perceived bodily pain, emotional ailments, and perceived mental health. Conclusions: More systematic research with larger sample sizes is required to overcome sampling bias and include health care professionals’ perspectives, as well as help patients mobilize support from health care professionals and social network partners. The evidence so far suggests that patients should be provided with digital interventions to manage symptoms and reintegrate into everyday life, including work. %M 36943909 %R 10.2196/45711 %U https://www.jmir.org/2023/1/e45711 %U https://doi.org/10.2196/45711 %U http://www.ncbi.nlm.nih.gov/pubmed/36943909 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42777 %T Translating Research Evidence Into Marketplace Application: Cohort Study of Internet-Based Intervention Platforms for Perinatal Depression %A Zeng,Zhen %A Peng,Jiale %A Liu,Lu %A Gong,Wenjie %+ HER Team and XiangYa School of Public Health, Central South University, 238 shangmayuanling, XiangYa Rd, Kaifu District, Changsha, Hunan, 410078, China, 86 13607445252, gongwenjie@csu.edu.cn %K cohort %K digital health %K internet-based intervention platform %K mhealth %K perinatal depression %K quality assessment %D 2023 %7 17.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-based intervention platforms may improve access to mental health care for women with perinatal depression (PND). Though the majority of platforms in the market lack an evidence base, a small number of them are supported by research evidence. Objective: This study aims to assess the current status of internet-based PND intervention platforms supported by published evidence, understand the reasons behind the disappearance of any of these previously accessible platforms, examine adjustments made by those active platforms between research trials and market implementation, and evaluate their current quality. Methods: A cohort of internet-based PND intervention platforms was first identified by systematic searches in multiple academic databases from database inception until March 26, 2021. We searched on the World Wide Web and the iOS and Android app stores to assess which of these were available in the marketplace between April and May 2021. The basic characteristics of all platforms were collected. For inaccessible platforms, inquiries were made via email to the authors of publications to determine the reasons for their unavailability. We compared the intervention-related information of accessible platforms in the marketplace with that reported in original publications and conducted quality assessments using the App Evaluation Model of the American Psychiatric Association. Fisher exact tests were used to compare the functional characteristics in publications of available and unavailable platforms and to investigate potential associations between functional adjustments or quality indices and platform survival time. Results: Out of 35 platforms supported by research evidence, only 19 (54%) were still accessible in the marketplace. The main reason for platforms disappearing was the termination of research projects. No statistically significant differences were found in functional characteristics between available and unavailable platforms. A total of 18 (95%) platforms adapted their core functions from what was reported in related publications. The adjustments included changes to intervention methods (11/19, 58%), target population (10/19, 53%), human resources for intervention support (9/19, 47%), mood assessment and monitoring (8/19, 42%), communication modality (4/19, 21%), and platform type (2/19, 11%). Quality issues across platforms included low frequency of update, lack of crisis management mechanism, poor user interactivity, and weak evidence base or absence of citation of supporting evidence. Platforms that survived longer than 10 years had a higher tendency to use external resources from third parties compared to those that survived less than 10 years (P=.04). No significant differences were found for functional adjustments or other quality indices. Conclusions: Internet-based platforms supported by evidence were not effectively translated into real-world practice. It is unclear if adjustments to accessible platforms made during actual operation may undermine the proven validity of the original research. Future research to explore the reasons behind the success of the implementation of evidence-based platforms in the marketplace is warranted. %M 37067855 %R 10.2196/42777 %U https://www.jmir.org/2023/1/e42777 %U https://doi.org/10.2196/42777 %U http://www.ncbi.nlm.nih.gov/pubmed/37067855 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44503 %T An Avatar-Led Web-Based and SMS Text Message Smoking Cessation Program for Socioeconomically Disadvantaged Veterans: Pilot Randomized Controlled Trial %A Heffner,Jaimee L %A Kelly,Megan M %A Reilly,Erin D %A Reece,Scott G %A Claudio,Tracy %A Serfozo,Edit %A Baker,Kelsey %A Watson,Noreen L %A Karekla,Maria %+ Fred Hutchinson Cancer Center, 1100 Fairview Ave N, M3-B232 PO Box 19024, Seattle, WA, 98109, United States, 1 2066677314, jheffner@fredhutch.org %K embodied agent %K tobacco cessation %K nicotine dependence %K mobile health %K mHealth %D 2023 %7 14.4.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Despite the declining prevalence of cigarette smoking in the United States, socioeconomically disadvantaged veterans receiving care from the Veterans Health Administration have a high prevalence of smoking. Currently, available treatment options for these veterans focus on tobacco users who are ready to quit and have limited reach. Consequently, there is a great need for accessible, effective smoking cessation interventions for veterans at all levels of readiness to quit smoking. Objective: To address these needs, we developed Vet Flexiquit, a web-based Acceptance and Commitment Therapy program for veterans, and evaluated its acceptability (primary aim), efficacy, and impact on theory-based change processes relative to the National Cancer Institute’s SmokefreeVET program in a pilot randomized controlled trial. Methods: Participants (N=49) were randomized 1:1 to receive either the Vet Flexiquit (n=25) or SmokefreeVET (n=24) web program. Both groups received SMS text messages as part of the intervention for 6 weeks. Both interventions are fully automated and self-guided. Primary outcome data were collected at 3 months after the randomization. Self-reported smoking abstinence was biochemically verified using saliva cotinine. Multivariable logistic regression, negative binomial regression, and linear regression models were used to evaluate the association between the treatment arm and outcomes of interest. Results: Acceptability, as measured by overall treatment satisfaction, was high and similar across treatment arms: 100% (17/17) for Vet Flexiquit and 95% (18/19) for SmokefreeVET. Acceptability, as measured by utilization, was more modest (log-ins: M=3.7 for Vet Flexiquit and M=3.2 for SmokefreeVET). There were no statistically significant differences between treatment arms for any acceptability measures. Similarly, there were no statistically significant differences between treatment arms in the secondary outcomes of smoking cessation or change in Acceptance and Commitment Therapy’s theory-based processes. In open-ended survey responses, some veterans in both treatment arms expressed interest in having support from a professional or peer to enhance their experience, as well as an expanded SMS text messaging program. Conclusions: Both programs had high ratings of acceptability, limited utilization, and a similar impact on cessation and cessation processes. Taken together with the qualitative data suggesting that additional support may enhance participants’ experience of both programs, these preliminary findings suggest that the programs may have similar outcomes among veterans who are looking for a digital cessation treatment option and that integrating provider or peer support and enhancing the SMS text messaging program holds promise as a means of boosting engagement and outcomes for both programs. Trial Registration: ClinicalTrials.gov NCT04502524; https://clinicaltrials.gov/ct2/show/NCT04502524 %M 37058346 %R 10.2196/44503 %U https://formative.jmir.org/2023/1/e44503 %U https://doi.org/10.2196/44503 %U http://www.ncbi.nlm.nih.gov/pubmed/37058346 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e41211 %T Interest in Digital Peer-Delivered Interventions and Preferences to Improve Pain Self-efficacy and Reduce Loneliness Among Patients With Chronic Pain: Mixed Methods Co-design Study %A Yates,Eloise %A Buckley,Lisa %A Sterling,Michele %A Cruwys,Tegan %A Ashton-James,Claire E %A Rankin,Renee %A Elphinston,Rachel A %+ RECOVER Injury Research Centre, The University of Queensland, Level 7, Surgical Treatment and Rehabilitation Service, 296 Herston Road, Herston, Brisbane, 4006, Australia, 61 412662084, rachelel@uq.edu.au %K chronic noncancer pain %K pain %K self-efficacy %K peer support %K peer-led intervention %K peer-led %K peer delivered %K peer intervention %K pain self-efficacy %K social connectedness %K social support %K loneliness %K lonely %K social isolation %K co-design %K participatory design %K qualitative research %K digital health %D 2023 %7 14.4.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Two important factors that prolong and exacerbate chronic noncancer pain (CNCP) and disability are low pain self-efficacy and loneliness. Yet, few interventions have shown long-term sustained improvements in pain self-efficacy, and there are no evidence-based treatments that target social connectedness in people living with CNCP. More effective and accessible interventions designed to target self-efficacy and social connectedness could ease the burden of CNCP. Objective: To co-design accessible interventions to increase pain self-efficacy, social connection, pain-related outcomes, and quality of life, this study explored patients’ interest and preferences for digital peer-delivered interventions for CNCP as well as implementation barriers and enablers. Methods: This cross-sectional mixed methods study was part of a larger longitudinal cohort study. Adult Australian residents (N=186) with CNCP diagnosed by a medical professional or pain specialist were included. Participants were initially recruited through advertising on professional pain social media accounts and websites. Questions examined whether patients were interested in digital peer-delivered interventions and their preferences for specific features (eg, Newsfeed). Pain self-efficacy and loneliness were assessed using validated questionnaires, and the association between these factors and interest in digital peer-delivered support was explored. Open-ended questions explored implementation barriers, enablers, and suggestions for consideration in intervention design. Results: There was interest in accessing digital peer-delivered interventions, with almost half of the sample indicating that they would access it if it was available. Those who indicated an interest in digital peer interventions reported both lower pain self-efficacy and greater loneliness than those who were not interested. Intervention content that incorporated education, links to health services and resources, and delivery of support by peer coaches were the most frequently preferred intervention features. Three potential benefits were identified: shared experience, social connection, and shared pain management solutions. Five potential barriers were identified: negative focus on pain, judgment, lack of engagement, negative impact on mental health, privacy and security concerns, and unmet personal preferences. Finally, there were 8 suggestions from participants: moderation of the group, interest subgroups, professional-led activities, psychological strategies, links to professional pain resources, newsletter, motivational content, live streaming, and online meetups. Conclusions: Digital peer-delivered interventions were of particular interest to those with CNCP who had lower levels of pain self-efficacy and higher levels of loneliness. Future co-design work could tailor digital peer-delivered interventions to these unmet needs. Intervention preferences and implementation barriers and enablers identified in this study could guide further co-design and the development of such interventions. %M 37058351 %R 10.2196/41211 %U https://formative.jmir.org/2023/1/e41211 %U https://doi.org/10.2196/41211 %U http://www.ncbi.nlm.nih.gov/pubmed/37058351 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e38688 %T Improving Bystander Self-efficacy to Prevent Violence Against Women Through Interpersonal Communication Using Mobile Phone Entertainment Education: Randomized Controlled Trial %A Pant,Ichhya %A Kang,Bee-Ah %A Rimal,Rajiv %+ Department of Prevention and Community Health, George Washington University Milken Institute School of Public Health, 950 New Hampshire Ave NW, Washington, DC, 20052, United States, 1 404 461 9851, ipant@gwu.edu %K mHealth %K voice-response %K entertainment education %K rural %K bystander %K self-efficacy %K violence against women %K interpersonal communication %K violence %K women %K society %D 2023 %7 14.4.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Violence against women is a major challenge worldwide and in India. Patriarchal social and gender norms suppress disclosure of violence experienced by women. Stimulating interpersonal communication about a normatively stigmatized but prevalent topic could offer an avenue toward boosting bystander self-efficacy to intervene and prevent violence against women. Objective: In this study, to reduce violence against women as the distal goal, we adopted a two-pronged strategy grounded in Carey’s model of communication, approaching the issue in an incremental way. First, we aimed to explore whether the intervention promoted interpersonal communication about violence against women as an initial step. Second, we examined whether the intervention improved women’s self-efficacy to intervene when they witness violence in their community through interpersonal communication. Our model is based on the social cognitive theory that posits observational learning (ie, hearing about other women interfering to stop violence) fosters self-efficacy, a proxy for behavior change. Methods: We conducted a randomized controlled trial of women of reproductive age using a 2-arm study design embedded within a parent trial implemented in Odisha, India. In total, 411 participants were randomly assigned to the violence against women intervention arm or a control arm if they were active mobile phone owners and assigned to the treatment arm of the parent trial. Participants received 13 entertainment education episodes daily as phone calls. The intervention included program-driven, audience-driven, and responsive interaction strategies to facilitate the active engagement of participants. Audience-driven interactions were incorporated throughout the episodes using an interactive voice response system, which allowed participants to like or replay individual episodes through voice-recognition or touch-tone keypad. Our primary analysis involved a structural equation model with interpersonal communication as a potential mediator on the pathway between intervention exposure and bystander self-efficacy to prevent violence against women. Results: The findings from structural equation modeling demonstrated the significant mediating effect of interpersonal communication on the relationship between program exposure and bystander self-efficacy. Exposure was positively related to interpersonal communication (β=.21, SE=.05; z=4.31; P<.001) and bystander self-efficacy (β=.19, SE=.05; z=3.82; P<.001). Conclusions: Our results demonstrate participant engagement in interpersonal communication following exposure to a “light” entertainment education program with audio-only format via feature phones in rural settings can result in improved self-efficacy to prevent violence against women. This elevates the role of interpersonal communication as a mechanism of behavior change in mobile phone–based interventions, given that most entertainment education interventions tend to be mass media based. Our findings also show the potential of changing the environment where witnesses of violence deem it worthy of intervention and perceive higher efficacy to stop violence in the community, rather than putting the onus on the perpetrator, to prevent any counterproductive effects. Trial Registration: Clinical Trials Registry-India CTRI/2018/10/016186; https://tinyurl.com/bddp4txc %M 37058330 %R 10.2196/38688 %U https://formative.jmir.org/2023/1/e38688 %U https://doi.org/10.2196/38688 %U http://www.ncbi.nlm.nih.gov/pubmed/37058330 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44131 %T Investigating Employees’ Concerns and Wishes Regarding Digital Stress Management Interventions With Value Sensitive Design: Mixed Methods Study %A Kerr,Jasmine I %A Naegelin,Mara %A Benk,Michaela %A v Wangenheim,Florian %A Meins,Erika %A Viganò,Eleonora %A Ferrario,Andrea %+ Mobiliar Lab for Analytics at ETH Zurich, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, Zürich, 8092, Switzerland, 41 44 632 65 83, jkerr@ethz.ch %K value sensitive design %K digital health intervention %K stress %K employee well-being %K monitoring %K machine learning %K ethics %K mobile phone %D 2023 %7 13.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Work stress places a heavy economic and disease burden on society. Recent technological advances include digital health interventions for helping employees prevent and manage their stress at work effectively. Although such digital solutions come with an array of ethical risks, especially if they involve biomedical big data, the incorporation of employees’ values in their design and deployment has been widely overlooked. Objective: To bridge this gap, we used the value sensitive design (VSD) framework to identify relevant values concerning a digital stress management intervention (dSMI) at the workplace, assess how users comprehend these values, and derive specific requirements for an ethics-informed design of dSMIs. VSD is a theoretically grounded framework that front-loads ethics by accounting for values throughout the design process of a technology. Methods: We conducted a literature search to identify relevant values of dSMIs at the workplace. To understand how potential users comprehend these values and derive design requirements, we conducted a web-based study that contained closed and open questions with employees of a Swiss company, allowing both quantitative and qualitative analyses. Results: The values health and well-being, privacy, autonomy, accountability, and identity were identified through our literature search. Statistical analysis of 170 responses from the web-based study revealed that the intention to use and perceived usefulness of a dSMI were moderate to high. Employees’ moderate to high health and well-being concerns included worries that a dSMI would not be effective or would even amplify their stress levels. Privacy concerns were also rated on the higher end of the score range, whereas concerns regarding autonomy, accountability, and identity were rated lower. Moreover, a personalized dSMI with a monitoring system involving a machine learning-based analysis of data led to significantly higher privacy (P=.009) and accountability concerns (P=.04) than a dSMI without a monitoring system. In addition, integrability, user-friendliness, and digital independence emerged as novel values from the qualitative analysis of 85 text responses. Conclusions: Although most surveyed employees were willing to use a dSMI at the workplace, there were considerable health and well-being concerns with regard to effectiveness and problem perpetuation. For a minority of employees who value digital independence, a nondigital offer might be more suitable. In terms of the type of dSMI, privacy and accountability concerns must be particularly well addressed if a machine learning-based monitoring component is included. To help mitigate these concerns, we propose specific requirements to support the VSD of a dSMI at the workplace. The results of this work and our research protocol will inform future research on VSD-based interventions and further advance the integration of ethics in digital health. %M 37052996 %R 10.2196/44131 %U https://www.jmir.org/2023/1/e44131 %U https://doi.org/10.2196/44131 %U http://www.ncbi.nlm.nih.gov/pubmed/37052996 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e37847 %T Sensory Overresponsivity and Symptoms Across the Obsessive-Compulsive Spectrum: Web-Based Longitudinal Observational Study %A Moreno-Amador,Beatriz %A Cervin,Matti %A Martínez-González,Agustin Ernesto %A Piqueras,Jose A %A , %+ Area of Personality, Assessment and Psychological Treatment, Department of Health Psychology, Universidad Miguel Hernández de Elche, Edificio Altamira, Avda. de la Universidad, s/n, Elche, 03202, Spain, 34 966658343, jpiqueras@umh.es %K sensory symptoms %K sensory overresponsivity %K obsessive-compulsive %K hair-pulling %K skin-picking %K hoarding %K body dysmorphic %K adolescents %K adults %D 2023 %7 13.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Sensory overresponsivity (SOR) has emerged as a potential endophenotype in obsessive-compulsive disorder (OCD), but few studies have examined SOR in relation to the major symptom dimensions of OCD and to symptoms across the full obsessive-compulsive (OC) symptom spectrum. Objective: This study had 2 main objectives. First, we examined the psychometric properties of the SOR Scales in a community-based sample of Spanish adolescents and adults. Second, we identified how SOR difficulties are related to symptoms across the full OC spectrum (eg, OC, body dysmorphic, hoarding, skin-picking, and hair-pulling symptoms), including the heterogeneity of OC symptoms. Methods: We translated the SOR Scales into Spanish—a measure that assesses SOR across the 5 sensory modalities—and created a web-based version of the measure. A sample of 1454 adolescents and adults (mean age 23.84, SD 8.46 years) participated in the study, and 388 (26.69%) participants completed the survey twice (approximately 8 months apart). The survey also contained a web-based measure that assesses symptoms across the full OC spectrum: harm and checking, taboo obsessions, contamination or cleaning, symmetry and ordering, body dysmorphic, hoarding, hair-pulling, and skin-picking symptoms. Results: The psychometric properties of the SOR Scales were excellent, and the test-retest reliability was adequate. All types of SOR were related to all major symptom dimensions of OCD and to all OC spectrum symptoms. Conclusions: SOR across the sensory modalities can be validly assessed using a web-based measure. SOR emerged as a pure transdiagnostic phenomenon in relation to symptoms across the OC spectrum, with no specific sensory modality being more strongly related to OC symptoms. SOR can shed much needed light on basic mechanisms that are important for the onset and maintenance of OC spectrum symptoms, and this study shows that large-scale web-based studies can aid in this endeavor. Future studies should examine whether SOR precedes or emerges alongside OC symptoms. %M 37052983 %R 10.2196/37847 %U https://www.jmir.org/2023/1/e37847 %U https://doi.org/10.2196/37847 %U http://www.ncbi.nlm.nih.gov/pubmed/37052983 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e40671 %T Sensa Mobile App for Managing Stress, Anxiety, and Depression Symptoms: Pilot Cohort Study %A Valinskas,Sarunas %A Nakrys,Marius %A Aleknavicius,Kasparas %A Jonusas,Justinas %+ KiloHealth, Antakalnio st. 17, Vilnius, LT 10312, Lithuania, 370 61456067, justinas.jonusas@kilo.health %K depression %K anxiety %K stress %K depressive %K DASS-21 %K mobile application %K CBT %K cognitive behavioral therapy %K psychotherapy %K mHealth %K mobile health %K Sensa %K app %K application %K health care %K intervention %K effectiveness %K assessment %K symptoms %K treatment %K mental health %D 2023 %7 13.4.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: An increase in depression, anxiety, and stress symptoms worldwide, attributed to the COVID-19 pandemic, has been reported. If not treated, it may negatively affect a person's everyday life by altering physical and social well-being and productivity and increasing expenditure on health care. Cognitive behavioral therapy (CBT)–based interventions are gaining popularity as a means to reduce stress and alleviate anxiety and depression symptoms. Moreover, CBT delivered through a mobile app has the same elements as traditional CBT training (eg, guided discovery). However, unlike conventional training, users of mobile apps are allowed to tailor their own experience at their own speed and schedule. Objective: This study aims to analyze Sensa users’ retrospective data and explore the dose-duration effect to find the optimal usage time when the user showed results. Methods: The study cohort comprised 381 consecutive community-based nonclinical users who started using Sensa between October 2021 and March 2022. All users included in the study took the Depression Anxiety Stress Scale-21 (DASS-21) assessment at least 2 times. Other parameters from the database containing all self-reported data were gender, number of active days, total time of use, and age. The primary outcome of the study was a change in the DASS-21 score. Statistical analyses were performed using GraphPad Prism (version 9, GraphPad Software). In addition, a logistic regression model was created to predict how the obtained independent parameters influenced the DASS-21 score. Results: The main finding of our study was that the majority of participants who started using Sensa were experiencing depression, anxiety, and stress symptoms (92.13%, 80.05%, and 87.93%, respectively). There was a statistically significant decrease of the DASS-21 subdomain scores after the use of the application (anxiety: mean 7.25, SD 4.03 vs mean 6.12, SD 4.00; P=.001; depression: mean 11.05, SD 4.26 vs mean 9.01, SD 4.77; P=.001; stress: mean 11.42, SD 3.44 vs mean 9.96, SD 3.65; P<.001). Finally, the logistic regression model showed that users who were using the app for more than 24 days and had at least 12 active days during that time had 3.463 (95% CI 1.142-11.93) and 2.644 (95% CI 1.024-7.127) times higher chances to reduce their DASS-21 subdomain scores of depression and anxiety, respectively. Conclusions: Using the Sensa mobile app was related to decreased depression, anxiety, and stress symptoms. %M 37052990 %R 10.2196/40671 %U https://formative.jmir.org/2023/1/e40671 %U https://doi.org/10.2196/40671 %U http://www.ncbi.nlm.nih.gov/pubmed/37052990 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44939 %T Efficacy of Mobile-Based Cognitive Behavioral Therapy on Lowering Low-density Lipoprotein Cholesterol Levels in Patients With Atherosclerotic Cardiovascular Disease: Multicenter, Prospective Randomized Controlled Trial %A Li,DuanBin %A Xu,Tian %A Xie,DaQi %A Wang,MiaoYun %A Sun,ShuPing %A Wang,Min %A Zhang,SiSi %A Yang,XinRui %A Zhang,ZhongNan %A Wang,Shen %A Kuang,Ming %A Tang,Jia %A Liu,HongYing %A Hong,XuLin %A Fu,GuoSheng %A Zhang,WenBin %+ Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, No. 3 Qingchun East Road, Shangcheng District, Zhejiang Province, Hangzhou, 310020, China, 86 0571 86006491, 3313011@zju.edu.cn %K mobile-based cognitive behavioral therapy %K low-density lipoprotein cholesterol %K atherosclerotic cardiovascular disease %K self-efficacy %K quality of life %D 2023 %7 12.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Elevated low-density lipoprotein cholesterol (LDL-C) is an established risk factor for atherosclerotic cardiovascular disease (ASCVD). However, low adherence to medication and lifestyle management has limited the benefits of lowering lipid levels. Cognitive behavioral therapy (CBT) has been proposed as a promising solution. Objective: This trial aimed to evaluate the efficacy of mobile-based CBT interventions in lowering LDL-C levels in patients with ASCVD. Methods: This multicenter, prospective, randomized controlled trial enrolled 300 patients with ASCVD, who were randomly assigned to the mobile-based CBT intervention group and the control group in a ratio of 1:1. The intervention group received CBT for ASCVD lifestyle interventions delivered by WeChat MiniApp: “CBT ASCVD.” The control group only received routine health education during each follow-up. The linear regression and logistic regression analyses were used to determine the effects of a mobile-based CBT intervention on LDL-C, triglyceride, C-reactive protein, the score of General Self-Efficacy Scale (GSE), quality of life index (QL-index), and LDL-C up-to-standard rate (<1.8 mmol/L) at the first, third, and sixth months. Results: Finally, 296 participants completed the 6-month follow-up (CBT group: n=148; control group: n=148). At baseline, the mean LDL-C level was 2.48 (SD 0.90) mmol/L, and the LDL-C up-to-standard rate (<1.8 mmol/L) was 21.3%. Mobile-based CBT intervention significantly increased the reduction of LDL-C change (%) at the 6-month follow-up (β=–10.026, 95% CI –18.111 to –1.940). In addition, this benefit remained when baseline LDL-C <1.8 mmol/L (β=–24.103, 95% CI –43.110 to –5.095). Logistic regression analysis showed that mobile-based CBT intervention moderately increased the LDL-C up-to-standard rates (<1.8 mmol/L) in the sixth month (odds ratio 1.579, 95% CI 0.994-2.508). For GSE and QL-index, mobile-based CBT intervention significantly increased the change of scores (%) at the 1-, 3-, and 6-month follow-up (all P values <.05). Conclusions: In patients with ASCVD, mobile-based CBT is effective in reducing LDL-C levels (even for those who already had a standard LDL-C) and can improve self-efficacy and quality of life. Trial Registration: Chinese Clinical Trial Registry ChiCTR2100046775; https://www.chictr.org.cn/showproj.aspx?proj=127140 %M 37043273 %R 10.2196/44939 %U https://www.jmir.org/2023/1/e44939 %U https://doi.org/10.2196/44939 %U http://www.ncbi.nlm.nih.gov/pubmed/37043273 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42581 %T Engagement With Tailored Physical Activity Content: Secondary Findings From the Families Improving Together for Weight Loss Randomized Controlled Trial %A Sweeney,Allison M %A Wilson,Dawn K %A Resnicow,Kenneth %A Van Horn,M Lee %A Kitzman,Heather %+ Department of Biobehavioral Health & Nursing Science, College of Nursing, University of South Carolina, 1601 Greene Street, Columbia, SC, 29201, United States, 1 8035767891, sweeneam@mailbox.sc.edu %K tailoring %K eHealth %K African Americans %K physical activity %K weight loss %D 2023 %7 12.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based tailored interventions offer rich opportunities for improved access to and personalization of behavioral interventions. However, despite the promise of this approach, the engagement and underrepresentation of minority groups remain major issues. Objective: This study evaluated whether engagement (log-in status and log-in duration) with different types of tailored behavioral content from the Families Improving Together for weight loss web-based intervention was associated with changes in moderate to vigorous physical activity (MVPA) among African American families with overweight or obesity. Methods: Parent-adolescent dyads were randomized to a web-based tailored intervention or web-based health education comparison program. The web-based intervention (N=119) was completed by parents and targeted 6 weight-related behaviors to support their adolescent children’s weight loss goals (session contents included energy balance, fast food, fruits and vegetables, physical activity [PA], sedentary behavior, and sweetened beverages). MVPA was measured using accelerometers at baseline and after the intervention. Results: Using a hierarchical approach, the log-in status and duration for each web-based session were used to evaluate the additive effects of engagement with different types of tailored behavioral content on MVPA after the web-based intervention. Among parents, logging in to the PA session was not associated with greater MVPA (B=−12.561, 95% CI −18.759 to −6.367), but MVPA increased with greater log-in duration for the PA (B=0.008, 95% CI 0.004-0.012) and sedentary behavior (B= 0.008, 95% CI 0.004-0.012) sessions. These results suggest that parents who logged in to the PA session had lower MVPA, but MVPA increased with greater log-in duration for the PA and sedentary behavior sessions. These associations remained even after accounting for engagement with other content sessions. However, these engagement effects did not translate to the adolescents. Conclusions: The results of this study highlight the need to disentangle the impact of engagement with different tailored content to improve the efficacy of tailored web-based interventions, especially for promoting PA in African American families. Trial Registration: ClinicalTrials.gov NCT01796067; https://clinicaltrials.gov/ct2/show/NCT01796067 %M 37043271 %R 10.2196/42581 %U https://www.jmir.org/2023/1/e42581 %U https://doi.org/10.2196/42581 %U http://www.ncbi.nlm.nih.gov/pubmed/37043271 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42455 %T The Added Value of Remote Technology in Cardiac Rehabilitation on Physical Function, Anthropometrics, and Quality of Life: Cluster Randomized Controlled Trial %A Lahtio,Heli %A Heinonen,Ari %A Paajanen,Teemu %A Sjögren,Tuulikki %+ Faculty of Sport and Health Sciences, University of Jyväskylä, P.O. Box 35, Jyväskylä, 40014, Finland, 358 14260 1211, heli.lahtio@gmail.com %K weight loss %K cardiac rehabilitation %K remote technology %K physical function %K 6-minute walk test %K overweight %K obesity %K body mass %K BMI %K waist circumference %K quality of life %K QoL %K mobile phone %D 2023 %7 12.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Cardiovascular diseases (CVDs) cause most deaths globally and can reduce quality of life (QoL) of rehabilitees with cardiac disease. The risk factors of CVDs are physical inactivity and increased BMI. With physical activity, it is possible to prevent CVDs, improve QoL, and help maintain a healthy body mass. Current literature shows the possibilities of digitalization and advanced technology in supporting independent self-rehabilitation. However, the interpretation of the results is complicated owing to the studies’ high heterogeneity. In addition, the added value of this technology has not been studied well, especially in cardiac rehabilitation. Objective: We aimed to examine the effectiveness of added remote technology in cardiac rehabilitation on physical function, anthropometrics, and QoL in rehabilitees with CVD compared with conventional rehabilitation. Methods: Rehabilitees were cluster randomized into 3 remote technology intervention groups (n=29) and 3 reference groups (n=30). The reference group received conventional cardiac rehabilitation, and the remote technology intervention group received conventional cardiac rehabilitation with added remote technology, namely, the Movendos mCoach app and Fitbit charge accelerometer. The 12 months of rehabilitation consisted of three 5-day in-rehabilitation periods in the rehabilitation center. Between these periods were two 6-month self-rehabilitation periods. Outcome measurements included the 6-minute walk test, body mass, BMI, waist circumference, and World Health Organization QoL-BREF questionnaire at baseline and at 6 and 12 months. Between-group differences were assessed using 2-tailed t tests and Mann-Whitney U test. Within-group differences were analyzed using a paired samples t test or Wilcoxon signed-rank test. Results: Overall, 59 rehabilitees aged 41 to 66 years (mean age 60, SD 6 years; n=48, 81% men) were included in the study. Decrement in waist circumference (6 months: 1.6 cm; P=.04; 12 months: 3 cm; P<.001) and increment in self-assessed QoL were greater (environmental factors: 0.5; P=.02) in the remote technology intervention group than the reference group. Both groups achieved statistically significant improvements in the 6-minute walk test in both time frames (P=.01-.03). Additionally, the remote technology intervention group achieved statistically significant changes in the environmental domain at 0-6 months (P=.03) and waist circumference at both time frames (P=.01), and reference group achieve statistically significant changes in waist circumference at 0-6 months (P=.02). Conclusions: Remote cardiac rehabilitation added value to conventional cardiac rehabilitation in terms of waist circumference and QoL. The results were clinically small, but the findings suggest that adding remote technology to cardiac rehabilitation may increase beneficial health outcomes. There was some level of systematic error during rehabilitation intervention, and the sample size was relatively small. Therefore, care must be taken when generalizing the study results beyond the target population. To confirm assumptions of the added value of remote technology in rehabilitation interventions, more studies involving different rehabilitees with cardiac disease are required. Trial Registration: ISRCTN Registry ISRCTN61225589; https://www.isrctn.com/ISRCTN61225589 %M 37043264 %R 10.2196/42455 %U https://www.jmir.org/2023/1/e42455 %U https://doi.org/10.2196/42455 %U http://www.ncbi.nlm.nih.gov/pubmed/37043264 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e39029 %T Time-Dependent Changes in Depressive Symptoms Among Control Participants in Digital-Based Psychological Intervention Studies: Meta-analysis of Randomized Controlled Trials %A Tong,Alan CY %A Ho,Florence SY %A Chu,Owen HH %A Mak,Winnie WS %+ Department of Psychology, The Chinese University of Hong Kong, Rm 354, Sino Building, New Territories, Hong Kong, 852 39436577, wwsmak@cuhk.edu.hk %K digital-based psychological intervention %K control groups %K meta-analysis %K depression %K depressive symptoms %K mobile phone %D 2023 %7 12.4.2023 %9 Review %J J Med Internet Res %G English %X Background: Digital-based psychological interventions (DPIs) have been shown to be efficacious in many randomized controlled trials (RCTs) in dealing with depression in adults. However, the effects of control comparators in these DPI studies have been largely overlooked, and they may vary in their effects on depression management. Objective: This meta-analytical study aimed to provide a quantitative estimate of the within-subject effects of control groups across different time intervals and explore the moderating effects of control types and symptom severity at baseline. Methods: A systematic literature search was conducted in late September 2021 on selected electronic databases: PubMed; ProQuest; Web of Science; and the Ovid system with MEDLINE, PsycINFO, and Embase. The control conditions in 107 RCTs with a total of 11,803 adults with depressive symptoms were included in the meta-analysis, and effect sizes (Hedges g) were calculated using the standardized mean difference approach. Study quality was assessed using the Cochrane risk-of-bias tool for randomized trials version 2. Results: The control conditions collectively yielded small to moderate effects in reducing depressive symptoms within 8 weeks since the baseline assessment (g=−0.358, 95% CI −0.434 to −0.281). The effects grew to moderate within 9 to 24 weeks (g=−0.549, 95% CI −0.638 to −0.460) and peaked at g=−0.810 (95% CI −0.950 to −0.670) between 25 and 48 weeks. The effects were maintained at moderate to large ranges (g=−0.769, 95% CI −1.041 to −0.498) beyond 48 weeks. The magnitude of the reduction differed across the types of control and severity of symptoms. Care as usual was the most powerful condition of all and produced a large effect (g=−0.950, 95% CI −1.161 to −0.739) in the medium term. The findings showed that waitlist controls also produced a significant symptomatic reduction in the short term (g=−0.291, 95% CI −0.478 to −0.104), refuting the previous suspicion of a nocebo effect. In addition, a large effect on depressive symptom reduction in the long term (g=−1.091, 95% CI −1.210 to −0.972) was noted among participants with severe levels of depressive symptoms at baseline. Conclusions: This study provided evidence that depressive symptoms generally reduced over time among control conditions in research trials of DPIs. Given that different control conditions produce variable and significant levels of symptomatic reduction, future intervention trials must adopt an RCT design and should consider the contents of control treatments when investigating the efficacy of DPIs. The results of waitlist controls confirmed previous findings of spontaneous recovery among people with mild to moderate depressive symptoms in face-to-face studies. Researchers may adopt watchful waiting as participants wait for the availability of digital-based psychological services. %M 37043276 %R 10.2196/39029 %U https://www.jmir.org/2023/1/e39029 %U https://doi.org/10.2196/39029 %U http://www.ncbi.nlm.nih.gov/pubmed/37043276 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45970 %T Barriers to and Facilitators of a Blended Cognitive Behavioral Therapy Program for Depression and Anxiety Based on Experiences of University Students: Qualitative Interview Study %A Braun,Pia %A Atik,Ece %A Guthardt,Lisa %A Apolinário-Hagen,Jennifer %A Schückes,Magnus %+ Institute of Occupational, Social and Environmental Medicine, Faculty of Medicine, Centre for Health and Society, Heinrich Heine University Düsseldorf, Moorenstr. 5, Düsseldorf, 40225, Germany, 49 211 8106477, jennifer.apolinario.hagen@hhu.de %K digital therapeutics %K blended cognitive behavioral therapy %K bCBT %K depression %K anxiety %K acceptance %K user experiences %K university students %K mobile phone %D 2023 %7 12.4.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Blended cognitive behavioral therapy (bCBT) programs have been proposed to increase the acceptance and adoption of digital therapeutics (DTx) such as digital health apps. These programs allow for more personalized care by combining regular face-to-face therapy sessions with DTx. However, facilitators of and barriers to the use of DTx in bCBT programs have rarely been examined among students, who are particularly at risk for developing symptoms of depression and anxiety disorders. Objective: This study aimed to evaluate the facilitators of and barriers to the use of a bCBT program with the elona therapy app among university students with mild to moderate depression or anxiety symptoms. Methods: Semistructured interviews were conducted via videoconference between January 2022 and April 2022 with 102 students (mean age 23.93, SD 3.63 years; 89/102, 87.2% female) from universities in North Rhine-Westphalia, Germany, after they had completed weekly individual cognitive behavioral therapy sessions (25 minutes each) via videoconference for 6 weeks and regularly used the depression (n=67, 65.7%) or anxiety (n=35, 34.3%) module of the app. The interviews were coded based on grounded theory. Results: Many participants highlighted the intuitive handling of the app and indicated that they perceived it as a supportive tool between face-to-face sessions. Participants listed other benefits, such as increased self-reflection and disorder-specific knowledge as well as the transfer of the content of therapy sessions into their daily lives. Some stated that they would have benefited from more personalized and interactive tasks. In general, participants mentioned the time requirement, increased use of the smartphone, and the feeling of being left alone with potentially arising emotions while working on tasks for the next therapy session as possible barriers to the use of the app. Data security was not considered a major concern. Conclusions: Students mostly had positive attitudes toward elona therapy as part of the bCBT program. Our study shows that DTx complementing face-to-face therapy sessions can be perceived as a helpful tool for university students with mild to moderate anxiety or depression symptoms in their daily lives. Future research could elaborate on whether bCBT programs might also be suitable for students with more severe symptoms of mental disorders. In addition, the methods by which such bCBT programs could be incorporated into the university context to reach students in need of psychological support should be explored. %M 37043272 %R 10.2196/45970 %U https://formative.jmir.org/2023/1/e45970 %U https://doi.org/10.2196/45970 %U http://www.ncbi.nlm.nih.gov/pubmed/37043272 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 7 %N %P e38900 %T Engagement in Self-measured Blood Pressure Monitoring Among Medically Underresourced Participants (the Reach Out Trial): Digital Framework Qualitative Study %A Hellem,Abby Katherine %A Whitfield,Candace %A Casetti,Amanda %A Robles,Maria Cielito %A Dinh,Mackenzie %A Meurer,William %A Skolarus,Lesli %+ Davee Department of Neurology, Feinberg School of Medicine, Northwestern University, 625 N. Michigan Ave Suite 11500, Chicago, IL, 60611, United States, 1 312 503 0399, lesli.skolarus@northwestern.edu %K mobile health %K mHealth %K cardiovascular disease %K hypertension %K blood pressure %K semistructured interviews %K intervention engagement %K social determinants of health %K DBCI framework %D 2023 %7 7.4.2023 %9 Original Paper %J JMIR Cardio %G English %X Background: Mobile health (mHealth) interventions serve as a scalable opportunity to engage people with hypertension in self-measured blood pressure (SMBP) monitoring, an evidence-based approach to lowering blood pressure (BP) and improving BP control. Reach Out is an SMS text messaging–based SMBP mHealth trial that aims to reduce BP among hypertensive patients recruited from the emergency department of a safety net hospital in a low-income, predominately Black city. Objective: As the benefits of Reach Out are predicated on participants’ engagement with the intervention, we sought to understand participants’ determinants of engagement via prompted SMBP with personalized feedback (SMBP+feedback). Methods: We conducted semistructured telephone interviews based on the digital behavior change interventions framework. Participants were purposively sampled from 3 engagement categories: high engagers (≥80% response to SMBP prompts), low engagers (≤20% response to BP prompts), and early enders (participants who withdrew from the trial). Results: We conducted interviews with 13 participants, of whom 7 (54%) were Black, with a mean age of 53.6 (SD 13.25) years. Early enders were less likely to be diagnosed with hypertension prior to Reach Out, less likely to have a primary care provider, and less likely to be taking antihypertensive medications than their counterparts. Overall, participants liked the SMS text messaging design of the intervention, including the SMBP+feedback. Several participants across all levels of engagement expressed interest in and identified the benefit of enrolling in the intervention with a partner of their choice. High engagers expressed the greatest understanding of the intervention, the least number of health-related social needs, and the greatest social support to engage in SMBP. Low engagers and early enders shared a mixed understanding of the intervention and less social support compared to high engagers. Participation decreased as social needs increased, with early enders sharing the greatest amount of resource insecurity apart from a notable exception of a high engager with high health-related social needs. Conclusions: Prompted SMBP+feedback was perceived favorably by all participants. To enhance SMBP engagement, future studies could consider greater support in the initiation of SMBP, evaluating and addressing participants’ unmet health-related social needs, as well as strategies to cultivate social norms. %M 37027200 %R 10.2196/38900 %U https://cardio.jmir.org/2023/1/e38900 %U https://doi.org/10.2196/38900 %U http://www.ncbi.nlm.nih.gov/pubmed/37027200 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43738 %T Implementing Blended Care to Discontinue Benzodiazepine Receptor Agonist Use for Insomnia: Process Evaluation of a Pragmatic Cluster Randomized Controlled Trial %A Coteur,Kristien %A Van Nuland,Marc %A Schoenmakers,Birgitte %A Anthierens,Sibyl %A Van den Broeck,Kris %+ Academic Centre for General Practice, Department of Public Health and Primary Care, KU Leuven, Kapucijnenvoer 7, Leuven, 3000, Belgium, 32 16194265, kristien.coteur@kuleuven.be %K benzodiazepines %K long-term use %K deprescriptions %K deprescribing %K telemedicine %K general practice %K insomnia %K cognitive behavioral therapy %K eHealth %D 2023 %7 7.4.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Long-term use of benzodiazepine receptor agonists (BZRAs) remains common despite European guidelines advising that these drugs be used in the lowest possible dose and for the shortest possible duration. Half of all BZRAs are prescribed in family practice. This creates a window of opportunity for discontinuation in primary care. Therefore, the effectiveness of blended care for the discontinuation of long-term BZRA use in adult primary care patients with chronic insomnia disorder was tested in a multicenter, pragmatic, and cluster randomized controlled superiority trial in Belgium. In the literature, information on implementing blended care in a primary care setting is scarce. Objective: The study aimed to contribute to a framework for the successful implementation of blended care in a primary care setting by increasing our understanding of this complex intervention through an evaluation of e-tool use and views and ideas of participants in a BZRA discontinuation trial. Methods: Based on a theoretical framework, this study evaluated the processes of recruitment, delivery, and response using 4 components: a survey on recruitment (n=76), semistructured in-depth interviews with patients (n=18), web-based asynchronous focus groups with general practitioners (GPs; n=19), and usage data of the web-based tool. Quantitative data were analyzed descriptively, and qualitative data were analyzed thematically. Results: For recruitment, the most common barriers were refusal by the patient and the lack of digital literacy, while facilitators were starting the conversation and the curiosity of patients. The delivery of the intervention to the patients was diverse, ranging from GPs who never informed the patient about their access to the e-tool to GPs consulting the e-tool in between consultations to have discussion points when the patient visited. Concerning response, patients’ and GPs’ narratives also showed much variety. For some GPs, daily practice changed because they received more positive reactions than expected and felt empowered to talk more often about BZRA discontinuation. Conversely, some GPs reported no changes in practice or among patients. In general, patients found follow-up by an expert to be the most important component in blended care, whereas GPs deemed the intrinsic motivation of patients to be the key element of success. An important barrier to implementation by the GP was time. Conclusions: Overall, the participants who had used the e-tool were positive about its structure and content. Nevertheless, many patients desired a more tailored application with feedback from an expert and personal tapering schedules. Strict pragmatic implementation of blended care seems to only reach GPs with an interest in digitalization. Although not superior to usual care, blended care could be a complementary tool that allows tailoring the discontinuation process to the personal style of the GP and the needs of the patient. Trial Registration: ClinicalTrials.gov NCT03937180; https://clinicaltrials.gov/ct2/show/NCT03937180 %M 37027198 %R 10.2196/43738 %U https://formative.jmir.org/2023/1/e43738 %U https://doi.org/10.2196/43738 %U http://www.ncbi.nlm.nih.gov/pubmed/37027198 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43839 %T The Efficacy and Usability of an Unguided Web-Based Grief Intervention for Adults Who Lost a Loved One During the COVID-19 Pandemic: Randomized Controlled Trial %A Dominguez-Rodriguez,Alejandro %A Sanz-Gomez,Sergio %A González Ramírez,Leivy Patricia %A Herdoiza-Arroyo,Paulina Erika %A Trevino Garcia,Lorena Edith %A de la Rosa-Gómez,Anabel %A González-Cantero,Joel Omar %A Macias-Aguinaga,Valeria %A Miaja,Melina %+ School of Psychology, Universidad Internacional del Ecuador, Av. Simón Bolívar and Av. Jorge Fernández, Quito, 170102, Ecuador, 593 22985 600, pherdoiza@uide.edu.ec %K web-based intervention %K usability %K complicated grief %K hopelessness %K suicidal risk %K depression %K anxiety %K posttraumatic stress %K mobile phone %D 2023 %7 6.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: The death of a loved one was a challenge many people faced during the COVID-19 pandemic within the context of extraordinary circumstances and great uncertainty. Grief is an unavoidable part of life, and for most people, feelings of grief decrease naturally over time. However, for some people, grieving can become a particularly painful process with clinical symptoms that may require professional help to resolve. To provide psychological support to people who had lost a loved one during the COVID-19 pandemic, an unguided web-based psychological intervention was developed. Objective: The main objective of this study was to evaluate the efficacy of the web-based treatment, Grief COVID (Duelo COVID in Spanish; ITLAB), in reducing clinical symptoms of complicated grief, depression, posttraumatic stress, hopelessness, anxiety, and suicidal risk in adults. The secondary aim was to validate the usability of the self-applied intervention system. Methods: We used a randomized controlled trial with an intervention group (IG) and a waitlist control group (CG). The groups were assessed 3 times (before beginning the intervention, upon completing the intervention, and 3 months after the intervention). The intervention was delivered on the web in an asynchronous format through the Duelo COVID web page. Participants created an account that could be used on their computers, smartphones, or tablets. The evaluation process was automated as part of the intervention. Results: A total of 114 participants were randomly assigned to the IG or CG and met criteria for inclusion in the study (n=45, 39.5% completed the intervention and n=69, 60.5% completed the waitlist period). Most participants (103/114, 90.4%) were women. The results indicated that the treatment significantly reduced baseline clinical symptoms in the IG for all variables (P<.001 to P=.006), with larger effect sizes for depression, hopelessness, grief, anxiety, and risk of suicide (all effect sizes ≥0.5). The follow-up evaluation showed that symptom reduction was maintained at 3 months after the intervention. The results from the CG showed that participants experienced significantly decreased levels of hopelessness after completing the time on the waitlist (P<.001), but their suicidal risk scores increased. Regarding the usability of the self-applied intervention system, the results indicated a high level of satisfaction with the Grief COVID. Conclusions: The self-applied web-based intervention Grief COVID was effective in reducing symptoms of anxiety, depression, hopelessness, risk of suicide risk, posttraumatic stress disorder, and complicated grief disorder. Grief COVID was evaluated by the participants, who reported that the system was easy to use. These results affirm the importance of developing additional web-based psychological tools to help reduce clinical symptoms in people experiencing grief because of the loss of a loved one during a pandemic. Trial Registration: ClinicalTrials.gov NCT04638842; https://clinicaltrials.gov/ct2/show/NCT04638842 %M 36877800 %R 10.2196/43839 %U https://www.jmir.org/2023/1/e43839 %U https://doi.org/10.2196/43839 %U http://www.ncbi.nlm.nih.gov/pubmed/36877800 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42325 %T The Effectiveness of Online-Only Blended Cardiopulmonary Resuscitation Training: Static-Group Comparison Study %A Chong,Kah Meng %A Yang,Hsiang-Wen %A He,Hsien-Chin %A Lien,Wan-Ching %A Yang,Mei-Fen %A Chi,Chien-Yu %A Chen,Yen-Pin %A Huang,Chien-Hua %A Ko,Patrick Chow-In %+ Department of Emergency Medicine, National Taiwan University Hospital, No 7 ZhongShan South Road, Taipei City, 100, Taiwan, 886 2 23123456 ext 262831, patrick.patko@gmail.com %K basic life support %K cardiopulmonary resuscitation education %K distance learning %K self-directed learning %K deliberate practice %K blended learning %K digital health intervention %K virtual learning %K virtual education %K online course %K digital training %K online learning %K classroom-based blended learning %K educational outcomes %K remote education %K remote learning %K static-group comparison study %K online lectures %K cardiopulmonary resuscitation %K resuscitation %D 2023 %7 5.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Basic life support (BLS) education is essential for improving bystander cardiopulmonary resuscitation (CPR) rates, but the imparting of such education faces obstacles during the outbreak of emerging infectious diseases, such as COVID-19. When face-to-face teaching is limited, distance learning—blended learning (BL) or an online-only model—is encouraged. However, evidence regarding the effect of online-only CPR training is scarce, and comparative studies on classroom-based BL (CBL) are lacking. While other strategies have recommended self-directed learning and deliberate practice to enhance CPR education, no previous studies have incorporated all of these instructional methods into a BLS course. Objective: This study aimed to demonstrate a novel BLS training model—remote practice BL (RBL)—and compare its educational outcomes with those of the conventional CBL model. Methods: A static-group comparison study was conducted. It included RBL and CBL courses that shared the same paradigm, comprising online lectures, a deliberate practice session with Little Anne quality CPR (QCPR) manikin feedback, and a final assessment session. In the main intervention, the RBL group was required to perform distant self-directed deliberate practice and complete the final assessment via an online video conference. Manikin-rated CPR scores were measured as the primary outcome; the number of retakes of the final examination was the secondary outcome. Results: A total of 52 and 104 participants from the RBL and CBL groups, respectively, were eligible for data analysis. A comparison of the 2 groups revealed that there were more women in the RBL group than the CBL group (36/52, 69.2% vs 51/104, 49%, respectively; P=.02). After adjustment, there were no significant differences in scores for QCPR release (96.9 vs 96.4, respectively; P=.61), QCPR depth (99.2 vs 99.5, respectively; P=.27), or QCPR rate (94.9 vs 95.5, respectively; P=.83). The RBL group spent more days practicing before the final assessment (12.4 vs 8.9 days, respectively; P<.001) and also had a higher number of retakes (1.4 vs 1.1 times, respectively; P<.001). Conclusions: We developed a remote practice BL–based method for online-only distant BLS CPR training. In terms of CPR performance, using remote self-directed deliberate practice was not inferior to the conventional classroom-based instructor-led method, although it tended to take more time to achieve the same effect. Trial Registration: Not applicable. %M 37018023 %R 10.2196/42325 %U https://www.jmir.org/2023/1/e42325 %U https://doi.org/10.2196/42325 %U http://www.ncbi.nlm.nih.gov/pubmed/37018023 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 6 %N %P e42972 %T A WeChat-based Intervention, Wellness Enhancement for Caregivers (WECARE), for Chinese American Dementia Caregivers: Pilot Assessment of Feasibility, Acceptability, and Preliminary Efficacy %A Hong,Y Alicia %A Shen,Kang %A Han,Hae-Ra %A Ta Park,Van %A Bagchi,Pramita %A Lu,Huixing Kate %A Chen,Hsiaoyin %A Wang,Judy Huei-yu %+ Department of Health Administration and Policy, College of Public Health, George Mason University, 4400 University Dr. MS 1j3, Fairfax, VA, 22030, United States, 1 7039931929, yhong22@gmu.edu %K Alzheimer disease %K dementia %K caregiver %K Chinese American %K mHealth intervention %K social media %K WeChat %K mHealth %K mobile health %K informal care %K caregiving %K family care %K spousal care %K minority %K ethnic %K cultural %K Chinese %D 2023 %7 5.4.2023 %9 Original Paper %J JMIR Aging %G English %X Background: Chinese American family caregivers of persons with dementia experience high rates of psychosocial distress and adverse health outcomes. Due to their immigrant and minority status, they face substantial obstacles to care and support, including stigma and misperception of dementia, limited knowledge and use of welfare and services, and poor social support. Few interventions have been developed or tested for this vulnerable population. Objective: This study aims to pilot-test the Wellness Enhancement for Caregivers (WECARE) intervention, a culturally tailored program delivered via WeChat, a social media app highly popular in the Chinese population. The 7-week WECARE was designed specifically for Chinese American dementia caregivers to improve their caregiving skills, reduce stress, and enhance psychosocial well-being. Feasibility, acceptability, and preliminary efficacy of the WECARE were assessed in this pilot. Methods: A total of 24 Chinese American family caregivers of persons with dementia were recruited for a pre-post 1-arm trial of the WECARE. By subscribing to the WECARE official account, participants received interactive multimedia programs on their WeChat account multiple times a week for 7 weeks. A backend database automatically delivered program components and tracked user activities. Three online group meetings were organized to facilitate social networking. Participants completed a baseline and a follow-up survey. Feasibility was assessed by the follow-up rate and curriculum completion rate; acceptability was assessed by user satisfaction and perceived usefulness of the program; and efficacy was assessed with pre-post differences in 2 primary outcomes of depressive symptoms and caregiving burden. Results: The intervention was completed by 23 participants with a retention rate of 96%. Most of them (n=20, 83%) were older than 50 years and the majority (n=17, 71%) were female. The backend database revealed that the mean curriculum completion rate was 67%. Participants also reported high rates of user satisfaction and perceived usefulness of the intervention and high ratings of weekly programs. The intervention led to significant improvement in participants’ psychosocial health outcomes; their depressive symptoms reduced from 5.74 to 3.35 with an effect size of −0.89 and caregiving burden decreased from 25.78 to 21.96 with an effect size of −0.48. Conclusions: This pilot study suggests that WeChat-based WECARE intervention was feasible and acceptable; it also demonstrated initial efficacy in improving psychosocial well-being in Chinese American dementia caregivers. Further research with a control group is needed to assess its efficacy and effectiveness. The study highlights the need for more culturally appropriate mobile health interventions for Chinese American family caregivers of persons with dementia. %M 37018042 %R 10.2196/42972 %U https://aging.jmir.org/2023/1/e42972 %U https://doi.org/10.2196/42972 %U http://www.ncbi.nlm.nih.gov/pubmed/37018042 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42556 %T Patients’ Perspectives Regarding Digital Health Technology to Support Self-management and Improve Integrated Stroke Care: Qualitative Interview Study %A Bally,Esmee L S %A Cheng,Demi %A van Grieken,Amy %A Ferri Sanz,Mireia %A Zanutto,Oscar %A Carroll,Aine %A Darley,Andrew %A Roozenbeek,Bob %A Dippel,Diederik W J %A Raat,Hein %+ Department of Public Health, Erasmus MC University Medical Center, Dr Molewaterplein 40, Rotterdam, 3015 GD, Netherlands, 31 10 703 8580, h.raat@erasmusmc.nl %K stroke patients %K digital health technology %K self-management %K co-design %K user-requirements %K user-centered design %K qualitative research %D 2023 %7 4.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital technologies such as mobile apps and robotics have the potential to involve stroke patients better in the care process and to promote self-management. However, barriers exist that constrain the adoption and acceptance of technology in clinical practice. Examples of barriers are privacy concerns, challenges regarding usability, and the perception that there is no need for health-related technology. To address these barriers, co-design can be used to enable patients to reflect on their experiences of a service and to tailor digital technologies to the needs and preferences of end users regarding content and usability. Objective: This study aims to explore the perspectives of stroke patients toward how digital health technology could support self-management regarding health and well-being, as well as integrated stroke care. Methods: A qualitative study was conducted to understand patient perspectives. Data were collected in co-design sessions during the ValueCare study. Patients from a Dutch hospital who experienced an ischemic stroke (n=36) within the past 18 months were invited to participate. Data collection took place between December 2020 and April 2021 via one-to-one telephone interviews. A short self-report questionnaire was used to collect data on sociodemographics, disease-specific information, and technology use. All interviews were audio-taped and transcribed verbatim. The interview data were analyzed using a thematic approach. Results: Patients held mixed attitudes toward digital health technologies. Some patients viewed digital technology as a convenient product or service, while others expressed no desire or need to use technology for self-management or care. Digital features suggested by stroke patients included (1) information about the causes of stroke, medication, prognosis, and follow-up care; (2) an online library with information regarding stroke-related health and care issues; (3) a personal health record by which patients can retrieve and manage their own health information; and (4) online rehabilitation support to empower patients to exercise at home. Regarding the user interface of future digital health technology, patients emphasized the need for easy-to-use and simple designs. Conclusions: Stroke patients mentioned credible health information, an online library with stroke-related health and care information, a personal health record, and online rehabilitation support as the main features to include in future digital health technologies. We recommend that developers and designers of digital health for stroke care listen to the “voice of the stroke patients” regarding both functionality and the characteristics of the interface. International Registered Report Identifier (IRRID): RR2-10.1186/s12877-022-03333-8 %M 37014677 %R 10.2196/42556 %U https://www.jmir.org/2023/1/e42556 %U https://doi.org/10.2196/42556 %U http://www.ncbi.nlm.nih.gov/pubmed/37014677 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e42272 %T Parental Information Needs and Intervention Preferences for Preventing Multiple Lifestyle Risk Behaviors Among Adolescents: Cross-sectional Survey Among Parents %A Champion,Katrina E %A Hunter,Emily %A Gardner,Lauren A %A Thornton,Louise K %A Chapman,Cath %A McCann,Karrah %A Spring,Bonnie %A Slade,Tim %A Teesson,Maree %A Newton,Nicola C %+ The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Level 6, Jane Foss Russell Building, Sydney, 2006, Australia, 61 8627 9006, katrina.champion@sydney.edu.au %K parents %K adolescents %K prevention %K risk behaviors %K intervention %K mobile phone %D 2023 %7 4.4.2023 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Parents play an influential role in the health behaviors of their children, such as physical activity, dietary intake, sleep, screen time, and substance use. However, further research is needed to inform the development of more effective and engaging parent-based interventions targeting adolescent risk behaviors. Objective: This study aimed to assess parents’ knowledge about adolescent risk behaviors, barriers and facilitators to engaging in healthy behaviors, and preferences for a parent-based prevention intervention. Methods: An anonymous web-based survey was conducted from June 2022 to August 2022. Eligible participants were parents of children aged 11 to 18 years and were residing in Australia at the time of this study. The survey assessed the parents’ perceived and actual knowledge about Australian health guidelines for youth, parent and adolescent engagement in health behaviors, parenting style and attitudes, barriers and facilitators to engaging in healthy behaviors, and delivery and component preferences for a parent-based preventive intervention. Descriptive statistics and logistic regressions were conducted to analyze the data. Results: A total of 179 eligible participants completed the survey. The mean age of the parents was 42.22 (SD 7.03) years, and 63.1% (101/160) were female. Parent-reported sleep duration was high for both parents (mean 8.31, SD 1.00 hours) and adolescents (mean 9.18, SD 0.94 hours). However, the proportion of parents who reported that their child met the national recommendations for physical activity (5/149, 3.4%), vegetable intake (7/126, 5.6%), and weekend recreational screen time (7/130, 5.4%) was very low. Overall, parents’ perceived knowledge of health guidelines was moderate, ranging from 50.6% (80/158) for screen time to 72.8% (115/158) for sleep guidelines (for children aged 5-13 years). Actual knowledge was lowest for vegetable intake and physical activity, with only 44.2% (46/104) and 42% (31/74) of parents reporting correct guidelines for these behaviors, respectively. The key issues of concern reported by parents were excessive use of technology, mental health, e-cigarette use, and negative peer relationships. The top-rated delivery method for a parent-based intervention was via a website (53/129, 41.1%). The highest rated intervention component was opportunities for goal-setting (89/126, 70.7% rated very or extremely important), and other important program features were ease of use (89/122, 72.9%), paced learning (79/126, 62.7%), and appropriate program length (74/126, 58.8%). Conclusions: The findings suggest that such interventions should be brief and web based and should aim to increase parental knowledge of health guidelines; provide opportunities for skill-building, such as goal-setting; and include effective behavior change techniques, such as motivational interviewing and social support. This study will inform the development of future parent-based preventive interventions to prevent multiple lifestyle risk behaviors among adolescents. %M 37014696 %R 10.2196/42272 %U https://pediatrics.jmir.org/2023/1/e42272 %U https://doi.org/10.2196/42272 %U http://www.ncbi.nlm.nih.gov/pubmed/37014696 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43293 %T Vickybot, a Chatbot for Anxiety-Depressive Symptoms and Work-Related Burnout in Primary Care and Health Care Professionals: Development, Feasibility, and Potential Effectiveness Studies %A Anmella,Gerard %A Sanabra,Miriam %A Primé-Tous,Mireia %A Segú,Xavier %A Cavero,Myriam %A Morilla,Ivette %A Grande,Iria %A Ruiz,Victoria %A Mas,Ariadna %A Martín-Villalba,Inés %A Caballo,Alejandro %A Esteva,Julia-Parisad %A Rodríguez-Rey,Arturo %A Piazza,Flavia %A Valdesoiro,Francisco José %A Rodriguez-Torrella,Claudia %A Espinosa,Marta %A Virgili,Giulia %A Sorroche,Carlota %A Ruiz,Alicia %A Solanes,Aleix %A Radua,Joaquim %A Also,María Antonieta %A Sant,Elisenda %A Murgui,Sandra %A Sans-Corrales,Mireia %A H Young,Allan %A Vicens,Victor %A Blanch,Jordi %A Caballeria,Elsa %A López-Pelayo,Hugo %A López,Clara %A Olivé,Victoria %A Pujol,Laura %A Quesada,Sebastiana %A Solé,Brisa %A Torrent,Carla %A Martínez-Aran,Anabel %A Guarch,Joana %A Navinés,Ricard %A Murru,Andrea %A Fico,Giovanna %A de Prisco,Michele %A Oliva,Vicenzo %A Amoretti,Silvia %A Pio-Carrino,Casimiro %A Fernández-Canseco,María %A Villegas,Marta %A Vieta,Eduard %A Hidalgo-Mazzei,Diego %+ Department of Psychiatry and Psychology, Institute of Neuroscience, Hospital Clínic de Barcelona, 170 Villarroel St, Barcelona, 08036, Spain, 34 606699877, dahidalg@clinic.cat %K primary care %K health care workers %K depression %K anxiety %K symptom %K burnout %K digital %K smartphone %K chatbot %K primary care digital support tool in mental health %K PRESTO %D 2023 %7 3.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Many people attending primary care (PC) have anxiety-depressive symptoms and work-related burnout compounded by a lack of resources to meet their needs. The COVID-19 pandemic has exacerbated this problem, and digital tools have been proposed as a solution. Objective: We aimed to present the development, feasibility, and potential effectiveness of Vickybot, a chatbot aimed at screening, monitoring, and reducing anxiety-depressive symptoms and work-related burnout, and detecting suicide risk in patients from PC and health care workers. Methods: Healthy controls (HCs) tested Vickybot for reliability. For the simulation study, HCs used Vickybot for 2 weeks to simulate different clinical situations. For feasibility and effectiveness study, people consulting PC or health care workers with mental health problems used Vickybot for 1 month. Self-assessments for anxiety (Generalized Anxiety Disorder 7-item) and depression (Patient Health Questionnaire-9) symptoms and work-related burnout (based on the Maslach Burnout Inventory) were administered at baseline and every 2 weeks. Feasibility was determined from both subjective and objective user-engagement indicators (UEIs). Potential effectiveness was measured using paired 2-tailed t tests or Wilcoxon signed-rank test for changes in self-assessment scores. Results: Overall, 40 HCs tested Vickybot simultaneously, and the data were reliably transmitted and registered. For simulation, 17 HCs (n=13, 76% female; mean age 36.5, SD 9.7 years) received 98.8% of the expected modules. Suicidal alerts were received correctly. For the feasibility and potential effectiveness study, 34 patients (15 from PC and 19 health care workers; 76% [26/34] female; mean age 35.3, SD 10.1 years) completed the first self-assessments, with 100% (34/34) presenting anxiety symptoms, 94% (32/34) depressive symptoms, and 65% (22/34) work-related burnout. In addition, 27% (9/34) of patients completed the second self-assessment after 2 weeks of use. No significant differences were found between the first and second self-assessments for anxiety (t8=1.000; P=.34) or depressive (t8=0.40; P=.70) symptoms. However, work-related burnout scores were moderately reduced (z=−2.07, P=.04, r=0.32). There was a nonsignificant trend toward a greater reduction in anxiety-depressive symptoms and work-related burnout with greater use of the chatbot. Furthermore, 9% (3/34) of patients activated the suicide alert, and the research team promptly intervened with successful outcomes. Vickybot showed high subjective UEI (acceptability, usability, and satisfaction), but low objective UEI (completion, adherence, compliance, and engagement). Vickybot was moderately feasible. Conclusions: The chatbot was useful in screening for the presence and severity of anxiety and depressive symptoms, and for detecting suicidal risk. Potential effectiveness was shown to reduce work-related burnout but not anxiety or depressive symptoms. Subjective perceptions of use contrasted with low objective-use metrics. Our results are promising but suggest the need to adapt and enhance the smartphone-based solution to improve engagement. A consensus on how to report UEIs and validate digital solutions, particularly for chatbots, is required. %M 36719325 %R 10.2196/43293 %U https://www.jmir.org/2023/1/e43293 %U https://doi.org/10.2196/43293 %U http://www.ncbi.nlm.nih.gov/pubmed/36719325 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42499 %T Evaluating the Efficacy of a Social Media–Based Intervention (Warna-Warni Waktu) to Improve Body Image Among Young Indonesian Women: Parallel Randomized Controlled Trial %A Garbett,Kirsty M %A Haywood,Sharon %A Craddock,Nadia %A Gentili,Caterina %A Nasution,Kholisah %A Saraswati,L Ayu %A Medise,Bernie Endyarni %A White,Paul %A Diedrichs,Phillippa C %A Williamson,Heidi %+ Centre for Appearance Research, University of the West of England, Frenchay Campus, Coldharbour Lane, Bristol, BS16 1QY, United Kingdom, 44 11732 82911, kirsty.garbett@uwe.ac.uk %K body image %K body dissatisfaction %K Indonesia %K adolescent mental health %K randomized controlled trial %K eHealth intervention %K Southeast Asia %K social media %K lower- and middle-income countries %K LMICs %D 2023 %7 3.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Body dissatisfaction is a global issue, particularly among adolescent girls and young women. Effective body image interventions exist but face barriers to scaling up, particularly in lower- and middle-income countries, such as Indonesia, where a need exists. Objective: We aimed to evaluate the acceptability and efficacy of Warna-Warni Waktu, a social media–based, fictional 6-episode video series with self-guided web-based activities for improving body image among young Indonesian adolescent girls and young women. We hypothesized that Warna-Warni Waktu would increase trait body satisfaction and mood and decrease internalization of appearance ideals and skin shade dissatisfaction relative to the waitlist control condition. We also anticipated improvements in state body satisfaction and mood immediately following each video. Methods: We conducted a web-based, 2-arm randomized controlled trial among 2000 adolescent girls and young women, aged 15 to 19 years, recruited via telephone by an Indonesian research agency. Block randomization (1:1 allocation) was performed. Participants and researchers were not concealed from the randomized arm. Participants completed self-report assessments of trait body satisfaction (primary outcome) and the internalization of appearance ideals, mood, and skin shade dissatisfaction at baseline (before randomization), time 2 (1 day after the intervention [T2]), and time 3 (1 month after the intervention [T3]). Participants also completed state body satisfaction and mood measures immediately before and after each video. Data were evaluated using linear mixed models with an intent-to-treat analysis. Intervention adherence was tracked. Acceptability data were collected. Results: There were 1847 participants. Relative to the control condition (n=923), the intervention group (n=924) showed reduced internalization of appearance ideals at T2 (F1,1758=40.56, P<.001, partial η2=0.022) and T3 (F1,1782=54.03, P<.001, partial η2=0.03) and reduced skin shade dissatisfaction at T2 (F1,1744=8.05, P=.005, partial η2=0.005). Trait body satisfaction improvements occurred in the intervention group at T3 (F1, 1781=9.02, P=.005, partial η2=0.005), which was completely mediated by the internalization change scores between baseline and T2 (indirect effect: β=.03, 95% CI 0.017-0.041; direct effect: β=.03, P=.13), consistent with the Tripartite Influence Model of body dissatisfaction. Trait mood showed no significant effects. Dependent sample t tests (2-tailed) found each video improved state body satisfaction and mood. Cumulative analyses found significant and progressive improvements in pre- and poststate body satisfaction and mood. Intervention adherence was good; participants watched an average of 5.2 (SD 1.66) videos. Acceptability scores were high for understandability, enjoyment, age appropriateness, usefulness, and likelihood to recommend. Conclusions: Warna-Warni Waktu is an effective eHealth intervention to reduce body dissatisfaction among Indonesian adolescent girls and young women. Although the effects were small, Warna-Warni Waktu is a scalable, cost-effective alternative to more intense interventions. Initially, dissemination through paid social media advertising will reach thousands of young Indonesian women. Trial Registration: ClinicalTrials.gov NCT05383807, https://clinicaltrials.gov/ct2/show/NCT05383807 ; ISRCTN Registry ISRCTN35483207, https://www.isrctn.com/ISRCTN35483207 International Registered Report Identifier (IRRID): RR2-10.2196/33596 %M 37010911 %R 10.2196/42499 %U https://www.jmir.org/2023/1/e42499 %U https://doi.org/10.2196/42499 %U http://www.ncbi.nlm.nih.gov/pubmed/37010911 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e38256 %T Virtual Reality Intervention for Patients With Neck Pain: Systematic Review and Meta-analysis of Randomized Controlled Trials %A Guo,Qifan %A Zhang,LIMing %A Gui,Chenfan %A Chen,Guanghui %A Chen,Yi %A Tan,Huixin %A Su,Wei %A Zhang,Ruishi %A Gao,Qiang %+ Department of Rehabilitation Medicine, West China Hospital, Sichuan University, No. 37 Guoxuexiang, Sichuan Province, Chengdu, 610041, China, 86 18980605992, gaoqiang_hxkf@163.com %K meta-analysis %K virtual reality %K neck pain %K disability %K systematic review %D 2023 %7 3.4.2023 %9 Review %J J Med Internet Res %G English %X Background: Neck pain is a prevalent condition that causes an enormous health care burden due to the lack of efficient therapies. As a promising technology, virtual reality (VR) has shown advantages in orthopedic rehabilitation. However, there is no meta-analysis evaluating the effectiveness of VR in neck pain management. Objective: This study aims to review original randomized controlled trials (RCTs) evaluating the effectiveness of VR for neck pain and to provide evidence for the clinical application of a new alternative approach for pain management. Methods: A total of 9 electronic databases were systematically searched for relevant articles published from inception to October 2022. RCTs in English or Chinese that investigated VR therapy for participants with neck pain were included. The methodological quality and the evidence level were assessed using the Cochrane Back and Neck Risk of Bias tool and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) guideline, respectively. Results: A total of 8 studies with 382 participants were included for the final analysis. For the pain intensity, the overall pooled effect size was 0.51, with a standardized mean difference (SMD) of −0.51 (95% CI −0.91 to −0.11; GRADE: moderate), favoring VR therapy compared with controls. Subgroups analyses revealed that significant differences in pain intensity were found in the multimodal intervention (VR in combination with other therapies) than in other interventions (SMD −0.45, 95% CI −0.78 to −0.13; GRADE: moderate), and better analgesic effects were also observed in patients with chronic neck pain receiving VR intervention (SMD −0.70, 95% CI −1.08 to −0.32; GRADE: moderate) and patients treated in the clinic or research unit (SMD −0.52, 95% CI −0.99 to −0.05; GRADE: moderate) than controls. Regarding other health outcomes, the VR experienced less disability, lower kinesiophobia, and greater kinematic function (cervical range of motion, mean and peak velocity). Nevertheless, the follow-up effects of VR therapy on pain intensity and disability were not found. Conclusions: Existing moderate evidence support VR as a beneficial nonpharmacological approach to improve pain intensity in patients with neck pain, with advantages to multimodal intervention, people with chronic neck pain, and clinic or research unit–based VR therapy. However, the limited quantity and high heterogeneity of the articles limit our findings. Trial Registration: PROSPERO CRD42020188635; https://tinyurl.com/2839jh8w %M 37010891 %R 10.2196/38256 %U https://www.jmir.org/2023/1/e38256 %U https://doi.org/10.2196/38256 %U http://www.ncbi.nlm.nih.gov/pubmed/37010891 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44086 %T Methodological Challenges in Web-Based Qualitative Research With Medically Underserved Populations %A Jackson,Alexandra Malia %A Woo,Juhee %A Olson,Marley %A Dalisay,Francis %A Pokhrel,Pallav %A Muller,Clemma J %A Okamoto,Scott K %+ Public Health, Pacific University, 2043 College Way, Forest Grove, OR, 97116, United States, 1 503 352 3136, lexie.jackson@pacificu.edu %K data collection %K internet %K mischievous responders %K recruitment %K qualitative %K technology %D 2023 %7 30.3.2023 %9 Viewpoint %J J Med Internet Res %G English %X Internet- or web-based research is rapidly increasing, offering multiple benefits for researchers. However, various challenges in web-based data collection have been illustrated in prior research, particularly since the onset of the COVID-19 pandemic. To add to the literature on best practices for web-based qualitative data collection, we present 4 case studies in which each research team experienced challenges unique to web-based qualitative research and had to modify their research approaches to preserve data quality or integrity. The first 2 case examples describe issues with using social media to recruit hard-to-reach populations, the third example demonstrates the challenge in engaging adolescents in sensitive conversations on the web, and the final example discusses both the issues in recruitment and the use of different modalities in collecting data to accommodate the medical needs of study participants. Based on these experiences, we provide guidance and future directions for journals and researchers in collecting qualitative data on the web. %M 36995748 %R 10.2196/44086 %U https://www.jmir.org/2023/1/e44086 %U https://doi.org/10.2196/44086 %U http://www.ncbi.nlm.nih.gov/pubmed/36995748 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e44862 %T The Effectiveness of a Smartphone Intervention Targeting Suicidal Ideation in Young Adults: Randomized Controlled Trial Examining the Influence of Loneliness %A McGillivray,Lauren %A Keng-Meng Hui,Nicholas %A Wong,Quincy J J %A Han,Jin %A Qian,Jiahui %A Torok,Michelle %+ Black Dog Institute, University of New South Wales, Hospital Rd, Sydney, 2031, Australia, 61 2 9065 9133, m.torok@unsw.edu.au %K loneliness %K suicidal ideation %K suicide prevention %K digital therapeutics %K smartphone intervention %K apps %D 2023 %7 30.3.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Loneliness is commonly reported by young people and has been shown to contribute to the rapid onset and escalation of depression and suicidal ideation during adolescence. Lonely people may also be particularly susceptible to disengaging from treatment early given the likelihood of their more complex clinical profiles leading to cognitive fatigue. While a smartphone intervention (LifeBuoy) has been shown to effectively reduce suicidal ideation in young adults, poor engagement is a well-documented issue for this therapeutic modality and has been shown to result in poorer treatment outcomes. Objective: This study aims to determine whether loneliness affects how young people experiencing suicidal ideation engage with and benefit from a therapeutic smartphone intervention (LifeBuoy). Methods: A total of 455 community-based Australian young adults (aged 18-25 years) experiencing recent suicidal ideation were randomized to use a dialectical behavioral therapy–based smartphone intervention (LifeBuoy) or an attention-matched control app (LifeBuoy-C) for 6 weeks. Participants completed measures of suicidal ideation, depression, anxiety, and loneliness at baseline (T0), post intervention (T1), and 3 months post intervention (T2). Piecewise linear mixed models were used to examine whether loneliness levels moderated the effect of LifeBuoy and LifeBuoy-C on suicidal ideation and depression across time (T0 to T1; T1 to T2). This statistical method was then used to examine whether app engagement (number of modules completed) influenced the relationship between baseline loneliness and suicidal ideation and depression across time. Results: Loneliness was positively associated with higher levels of overall suicidal ideation (B=0.75, 95% CI 0.08-1.42; P=.03) and depression (B=0.88, 95% CI 0.45-1.32; P<.001), regardless of time point or allocated condition. However, loneliness did not affect suicidal ideation scores across time (time 1: B=1.10, 95% CI –0.25 to 2.46; P=.11; time 2: B=0.43, 95% CI –1.25 to 2.12; P=.61) and depression scores across time (time 1: B=0.00, 95% CI –0.67 to 0.66; P=.99; time 2: B=0.41, 95% CI –0.37 to 1.18; P=.30) in either condition. Similarly, engagement with the LifeBuoy app was not found to moderate the impact of loneliness on suicidal ideation (B=0.00, 95% CI –0.17 to 0.18; P=.98) or depression (B=–0.08, 95% CI –0.19 to 0.03; P=.14). Conclusions: Loneliness was not found to affect young adults’ engagement with a smartphone intervention (LifeBuoy) nor any clinical benefits derived from the intervention. LifeBuoy, in its current form, can effectively engage and treat individuals regardless of how lonely they may be. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619001671156; https://tinyurl.com/yvpvn5n8 International Registered Report Identifier (IRRID): RR2-10.2196/23655 %M 36995752 %R 10.2196/44862 %U https://mental.jmir.org/2023/1/e44862 %U https://doi.org/10.2196/44862 %U http://www.ncbi.nlm.nih.gov/pubmed/36995752 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e43269 %T Experiences of Using an Electronic Health Tool Among Health Care Professionals Involved in Chronic Obstructive Pulmonary Disease Management: Qualitative Analysis %A Nyberg,André %A Sondell,Anna %A Lundell,Sara %A Marklund,Sarah %A Tistad,Malin %A Wadell,Karin %+ Department of Community Medicine and Rehabilitation, Section of Physiotherapy, Umeå University, Universitetstorget 4, Umeå, 901 87, Sweden, 46 907866639, andre.nyberg@umu.se %K COPD %K eHealth %K internet %K web based %K health care professionals %K primary care %K pulmonary %K management %K tools %K chronic %K clinical %K support %K care %K electronic %K implementation %D 2023 %7 30.3.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Chronic obstructive pulmonary disease (COPD) is one of the most common and deadliest chronic diseases of the 21st century. eHealth tools are seen as a promising way of supporting health care professionals in providing evidence-based COPD care, for example, by reinforcing information and interventions provided to the patients and providing easier access and support to the health care professional themselves. Still, knowledge is scarce on the experience of using eHealth tools from the perspective of the health care professional involved in COPD management. Objective: The study explored the experiences of using an eHealth tool among health care professionals that worked with patients with COPD in their daily clinical practice. Methods: This exploratory qualitative study is part of a process evaluation in a parallel group, controlled, pragmatic pilot trial. Semistructured interviews were performed with 10 health care professionals 3 and 12 months after getting access to an eHealth tool, the COPD Web. The COPD Web, developed using cocreation, is an interactive web-based platform that aims to help health care professionals provide health-promoting strategies. Data from the interviews were analyzed using qualitative content analysis with an inductive approach. Results: The main results reflected health care professionals’ experiences in 3 categories: receiving competence support and adjusting practice, improving quality of care, and efforts required for implementation. These categories highlighted that using an eHealth tool such as the COPD Web was experienced to provide knowledge support for health care professionals that led to adaptation and facilitation of working procedures and person-centered care. Taken together, these changes were perceived to improve the quality of care through enhanced patient contact and encouragement of interprofessional collaboration. In addition, health care professionals expressed that patients using the COPD Web were better equipped to tackle their disease and adhered better to provided treatment, increasing their self-management ability. However, structural and external barriers bar the successful implementation of an eHealth tool in daily praxis. Conclusions: This study is among the first to explore experiences of using an eHealth tool among health care professionals involved in COPD management. Our novel findings highlight that using an eHealth tool such as the COPD Web may improve the quality of care for patients with COPD (eg, by providing knowledge support for health care professionals and adapting and facilitating working procedures). Our results also indicate that an eHealth tool fosters collaborative interactions between patients and health care professionals, which explains why eHealth is a valuable means of encouraging well-informed and autonomous patients. However, structural and external barriers requiring time, support, and education must be addressed to ensure that an eHealth tool can be successfully implemented in daily praxis. Trial Registration: ClinicalTrials.gov NCT02696187; https://clinicaltrials.gov/ct2/show/NCT02696187 %M 36995743 %R 10.2196/43269 %U https://humanfactors.jmir.org/2023/1/e43269 %U https://doi.org/10.2196/43269 %U http://www.ncbi.nlm.nih.gov/pubmed/36995743 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e44867 %T A Brief Intervention for Improving Alcohol Literacy and Addressing Harmful Alcohol Use Among Women Attending an Australian Breast Screening Service (Health4her): Protocol for a Hybrid Effectiveness-Implementation Trial %A Grigg,Jasmin %A Manning,Victoria %A Lockie,Darren %A Giles,Michelle %A Bell,Robin %A Stragalinos,Peta %A Bernard,Chloe %A Volpe,Isabelle %A Greenwood,Christopher J %A Smith,Liam %A Bragge,Peter %A Lubman,Dan I %+ Turning Point, Eastern Health, 110 Church Street, Richmond, Melbourne, 3121, Australia, 61 8413 8413, jasmin.grigg@monash.edu %K alcohol %K alcohol literacy %K alcohol brief intervention %K breast cancer %K women’s health %K randomized controlled trial %K hybrid effectiveness-implementation trial %K protocol %D 2023 %7 30.3.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Alcohol consumption is a major modifiable risk factor for female breast cancer, even in small amounts. However, awareness of this risk remains low. National breast screening programs are uniquely positioned to provide timely and targeted health information and behavior change strategies to improve alcohol literacy and reduce consumption. A breast screening service is a novel health care setting for brief alcohol intervention, with the potential for extensive reach. Objective: This study aimed to conduct a formative evaluation with breast screening service consumers to understand the need for, and acceptability of, brief alcohol intervention in the breast screening setting and collaboratively design a brief alcohol intervention (Health4Her); to test the effectiveness of Health4Her in improving knowledge of alcohol as a breast cancer risk factor (primary outcome), improving alcohol literacy, and reducing consumption among women attending a breast screening service; and to examine the implementation strategy through process evaluation. Methods: This was a hybrid type II effectiveness-implementation trial comprising a randomized controlled trial (RCT) alongside a mixed methods program evaluation guided by applicable elements of the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework and Consolidated Framework for Implementation Research. Formative evaluation comprised a retrospective analysis of alcohol consumption data (n=49,240), a web-based survey (n=391), and focus groups and interviews (n=31) with breast screening service consumers. Women attending routine mammography, drinking at any level, were recruited to the single-site, double-blind RCT (n=558), and completed a baseline assessment before randomization (1:1) to receive Health4Her (alcohol brief intervention + lifestyle information) or control (lifestyle information) via animation on an iPad. Follow-up assessments were performed 4 and 12 weeks after randomization. The process evaluation included evaluation of trial administrative data, participant quantitative (n=497) and qualitative feedback (n=30), and site staff qualitative feedback (n=11). Results: This research was funded in March and May 2019. Data collection for the formative evaluation and trial recruitment occurred between January and April 2020 and February and August 2021, respectively, with finalization of follow-up data collection in December 2021. Quantitative process evaluation data were collected during trial implementation, and collection of participant and staff feedback was finalized in December 2021. Results of the retrospective analysis of alcohol consumption data from breast screening service consumers is anticipated to be published in March 2023 and the results of the RCT to be published in March 2023. Conclusions: This study is anticipated to generate new substantial knowledge on the alcohol consumption and literacy needs of women attending breast screening and the extent to which these can be addressed using a novel, tailored brief alcohol intervention. The study design permits the evaluation of the effectiveness and implementation of Health4Her to predict and facilitate uptake in breast screening services. Trial Registration: ClinicalTrials.gov NCT04715516; https://clinicaltrials.gov/ct2/show/NCT04715516 International Registered Report Identifier (IRRID): RR1-10.2196/44867 %M 36995739 %R 10.2196/44867 %U https://www.researchprotocols.org/2023/1/e44867 %U https://doi.org/10.2196/44867 %U http://www.ncbi.nlm.nih.gov/pubmed/36995739 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42845 %T Effectiveness of eHealth Interventions on Moderate-to-Vigorous Intensity Physical Activity Among Patients in Cardiac Rehabilitation: Systematic Review and Meta-analysis %A Yu,Tianzhuo %A Xu,Haiyan %A Sui,Xin %A Zhang,Xin %A Pang,Yue %A Yu,Tianyue %A Lian,Xiaoqian %A Zeng,Ting %A Wu,Yuejin %A Leng,Xin %A Li,Feng %+ School of Nursing, Jilin University, 965 Xinjiang St, Changchun, 130021, China, 86 17790089009, fli@jlu.edu.cn %K cardiac rehabilitation %K cardiorespiratory fitness %K cardiovascular diseases %K exercise %K physical activity %K heart disease risk factors %K meta-analysis %K systematic review %K eHealth %K telemedicine %D 2023 %7 29.3.2023 %9 Review %J J Med Internet Res %G English %X Background: Cardiac rehabilitation is a class IA recommendation for patients with cardiovascular diseases. Physical activity is the core component and core competency of a cardiac rehabilitation program. However, many patients with cardiovascular diseases are failing to meet cardiac rehabilitation guidelines that recommend moderate-to-vigorous intensity physical activity. Objective: The major objective of this study was to review the evidence of the effectiveness of eHealth interventions in increasing moderate-to-vigorous intensity physical activity among patients in cardiac rehabilitation. The secondary objective was to examine the effectiveness of eHealth interventions in improving cardiovascular-related outcomes, that is, cardiorespiratory fitness, waist circumference, and systolic blood pressure. Methods: A comprehensive search strategy was developed, and a systematic search of 4 electronic databases (PubMed, Web of Science, Embase, and Cochrane Library) was conducted for papers published from the start of the creation of the database until November 27, 2022. Experimental studies reporting on eHealth interventions designed to increase moderate-to-vigorous intensity physical activity among patients in cardiac rehabilitation were included. Multiple unblinded reviewers determined the study eligibility and extracted data. Risk of bias was evaluated using the Cochrane Collaboration Tool for randomized controlled trials and the Cochrane Effective Practice and Organization of Care group methods for nonrandomized controlled trials. A random-effect model was used to provide the summary measures of effect (ie, standardized mean difference and 95% CI). All statistical analyses were performed using Stata 17. Results: We screened 3636 studies, but only 29 studies were included in the final review, of which 18 were included in the meta-analysis. The meta-analysis demonstrated that eHealth interventions improved moderate-to-vigorous intensity physical activity (standardized mean difference=0.18, 95% CI 0.07-0.28; P=.001) and vigorous-intensity physical activity (standardized mean difference=0.2, 95% CI 0.00-0.39; P=.048) but did not improve moderate-intensity physical activity (standardized mean difference=0.19, 95% CI –0.12 to 0.51; P=.23). No changes were observed in the cardiovascular-related outcomes. Post hoc subgroup analyses identified that wearable-based, web-based, and communication-based eHealth intervention delivery methods were effective. Conclusions: eHealth interventions are effective at increasing minutes per week of moderate-to-vigorous intensity physical activity among patients in cardiac rehabilitation. There was no difference in the effectiveness of the major eHealth intervention delivery methods, thereby providing evidence that in the future, health care professionals and researchers can personalize convenient and affordable interventions tailored to patient characteristics and needs to eliminate the inconvenience of visiting center-based cardiac rehabilitation programs during the COVID-19 pandemic and to provide better support for home-based maintenance of cardiac rehabilitation. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42021278029; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=278029 %M 36989017 %R 10.2196/42845 %U https://www.jmir.org/2023/1/e42845 %U https://doi.org/10.2196/42845 %U http://www.ncbi.nlm.nih.gov/pubmed/36989017 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 8 %N %P e45241 %T Clinician Experiences With Hybrid Closed Loop Insulin Delivery Systems in Veterans With Type 1 Diabetes: Qualitative Study %A Mizokami-Stout,Kara %A Thompson,Holly M %A Hurren,Kathryn %A Leone,Virginia %A Piatt,Gretchen A %A Lee,Joyce M %A Pop-Busui,Rodica %A DeJonckheere,Melissa %+ Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, 1000 Wall Street, Ann Arbor, MI, 48105, United States, 1 734 232 1269, kmizokam@med.umich.edu %K automated insulin delivery %K hybrid closed loop %K type 1 diabetes %K endocrinology %K qualitative study %K insulin delivery %K digital health intervention %K thematic analysis %K diabetes management %D 2023 %7 29.3.2023 %9 Original Paper %J JMIR Diabetes %G English %X Background: Hybrid closed loop (HCL) insulin pumps adjust insulin delivery based on input from a continuous glucose monitor. Several systems are FDA approved and associated with improved time in range, reduction in hemoglobin A1c, and decreased incidence of hypoglycemia. Major diabetes guidelines differ in their strength of recommendations regarding the use of HCL systems. Overall, limited information about the factors that influence HCL pump clinical decision-making is available, especially among endocrinology clinicians. Objective: The study objective is to describe the knowledge and attitudes, network support, and self-efficacy regarding HCL insulin delivery systems among endocrinology clinicians in one Veterans Affairs (VA) Healthcare System in the Midwest. Methods: Following a descriptive approach, this qualitative study used semistructured interviews and inductive thematic analysis. All endocrinologists, endocrinology fellows, and nurses in the endocrinology and metabolism department at one VA Healthcare System in the Midwest were invited to participate in one-on-one phone interviews. Thematic analysis explored clinician perspectives on HCL insulin pump systems. Results: Participants (n=11) had experience within VA and university health care system endocrinology clinics. From their experiences, 4 themes were identified involving the evaluation and assessment of insulin pump candidates, prescribing challenges, clinical benefits of HCL pumps, and overall clinician confidence. Conclusions: Findings suggest that clinicians believe HCL systems have significant glycemic benefits but are not appropriate for all patients, especially those with cognitive impairment. HCL pump initiation is a multi-step process requiring an interdisciplinary team of health care clinicians to ensure patient and pump success. Furthermore, HCL systems improve clinician confidence in overall diabetes management. %M 36989019 %R 10.2196/45241 %U https://diabetes.jmir.org/2023/1/e45241 %U https://doi.org/10.2196/45241 %U http://www.ncbi.nlm.nih.gov/pubmed/36989019 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e26077 %T MyGood Trip, a Telemedicine Intervention for Physical Activity Recovery After Bariatric Surgery: Randomized Controlled Trial %A Lurbe i Puerto,Katia %A Bruzzi,Matthieu %A Rives-Lange,Claire %A Poghosyan,Tigran %A Bretault,Marion %A Chatellier,Gilles %A Vilfaillot,Aurelie %A Chevallier,Jean-Marc %A Czernichow,Sebastien %A Carette,Claire %+ Service de Nutrition, Centre Spécialisé Obésité, Hôpital Européen Georges Pompidou, Assistance Publique - Hôpitaux de Paris, 20 rue Leblanc, Paris, 75015, France, 33 1 56 09 55 21, claire.carette@aphp.fr %K bariatric surgery %K telemedicine %K physical activity %K RCT %K gastric bypass %K sleeve gastrectomy %K connected pedometer %K eHealth %K mixed methods research %D 2023 %7 28.3.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Despite bariatric surgery showing significant weight loss trajectories for many patients, a substantial proportion regain weight after the first year following surgery. The addition of telemedicine to standard care could support patients with engaging in a more active lifestyle and thus improve clinical outcomes. Objective: Our aim was to evaluate a telemedicine intervention program dedicated to the promotion of physical activity including digital devices, teleconsultation, and telemonitoring the first 6 months following bariatric surgery. Methods: This study employed a mixed methods design based on an open-label randomized controlled trial. Patients were included during the first week after bariatric surgery; then, they were randomized into 2 intervention groups: The TelePhys group received a monthly telemedicine consultation focusing on physical activity coaching, while the TeleDiet group received a monthly telemedicine consultation involving diet coaching. Data were collected using a watch pedometer and body weight scale, both of which were connected wirelessly. The primary outcome was the difference between the 2 groups in the mean numbers of steps at the first and sixth postoperative months. Weight change was also evaluated, and focus groups and interviews were conducted to enrich the results and capture perceptions of the telemedicine provided. Results: Among the 90 patients (mean age 40.6, SD 10.4 years; 73/90, 81% women; 62/90, 69% gastric bypass), 70 completed the study until the sixth month (n=38 TelePhys; n=32 TeleDiet), and 18 participants agreed to be interviewed (n=8 Telephys; n=10 TeleDiet). An increase in the mean number of steps between the first and sixth months was found in both groups, but this change was significant only in the TeleDiet group (P=.01). No difference was found when comparing both intervention groups. Interviewed participants reported having appreciated the teleconsultations, as the individualized tailored counseling helped them to make better choices about behaviors that could increase their likelihood of a daily life in better health. Weight loss followed by social factors (such as social support) were identified as the main facilitators to physical activity. Family responsibilities, professional constraints as well as poor urban policies promoting physical activity, and lack of accessibility to sport infrastructure were their major barriers to postoperative lifestyle adherence. Conclusions: Our study did not show any difference in mobility recovery after bariatric surgery related to a telemedicine intervention dedicated to physical activity. The early postoperative timing for our intervention may explain the null findings. eHealth interventions aiming to change behaviors and carried out by clinicians require support from structured public health policies that tackle patients’ obesogenic environment in order to be efficient in their struggle against sedentary lifestyle–related pathologies. Further research will need to focus on long-term interventions. Trial Registration: ClinicalTrials.gov NCT02716480, https://clinicaltrials.gov/ct2/show/NCT02716480 %M 36976624 %R 10.2196/26077 %U https://formative.jmir.org/2023/1/e26077 %U https://doi.org/10.2196/26077 %U http://www.ncbi.nlm.nih.gov/pubmed/36976624 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 7 %N %P e43781 %T Implementation and User Evaluation of an eHealth Technology Platform Supporting Patients With Cardiovascular Disease in Managing Their Health After a Cardiac Event: Mixed Methods Study %A Bente,Britt E %A Wentzel,Jobke %A Schepers,Celina %A Breeman,Linda D %A Janssen,Veronica R %A Pieterse,Marcel E %A Evers,Andrea W M %A van Gemert-Pijnen,Lisette %+ Department of Psychology, Health, and Technology, Faculty of Behavioral, Management and Social Sciences, University of Twente, Drienerlolaan 5, Enschede, 7522 NB, Netherlands, 31 53 489 9660, b.e.bente@utwente.nl %K patient needs %K health behavior %K lifestyle support %K user-centered design %K implementation %K evaluation %K cardiovascular disease %K app %K web-based platform %K intervention %D 2023 %7 24.3.2023 %9 Original Paper %J JMIR Cardio %G English %X Background: eHealth technology can help patients with cardiovascular disease adopt and maintain a healthy lifestyle by supporting self-management and offering guidance, coaching, and tailored information. However, to support patients over time, eHealth needs to blend in with their needs, treatment, and daily lives. Just as needs can differ between patients, needs can change within patients over time. To better adapt technology features to patients’ needs, it is necessary to account for these changes in needs and contexts of use. Objective: This study aimed to identify and monitor patients’ needs for support from a web-based health management platform and how these needs change over time. It aimed to answer the following research questions: “How do novice and more advanced users experience an online health management platform?” “What user expectations support or hinder the adoption of an online health management platform, from a user perspective?” and “How does actual usage relate to user experiences and adoption?” Methods: A mixed methods design was adopted. The first method involved 2 rounds of usability testing, followed by interviews, with 10 patients at 0 months (round 1) and 12 patients at 6 months (round 2). In the second method, log data were collected to describe the actual platform use. Results: After starting cardiac rehabilitation, the platform was used frequently. The patients mentioned that they need to have an incentive, set goals, self-monitor their health data, and feel empowered by the platform. However, soon after the rehabilitation program stopped, use of the platform declined or patients even quit because of the lack of continued tailored or personalized advice. The reward system motivated them to log data, but most participants indicated that being healthy should be the main focus, not receiving gifts. A web-based platform is flexible, accessible, and does not have any obligations; however, it should be implemented as an addition to regular care. Conclusions: Although use of the platform declined in the longer term, patients quitting the technology did not directly indicate that the technology was not functioning well or that patients no longer focused on achieving their values. The key to success should not be user adherence to a platform but adherence to healthy lifestyle habits. Therefore, the implementation of eHealth should include the transition to a stage where patients might no longer need support from a technology platform to be independently and sustainably adherent to their healthy lifestyle habits. This emphasizes the importance of conducting multi-iterative evaluations to continuously monitor whether and how patients’ needs and contexts of use change over time. Future research should focus on how this transition can be identified and monitored and how these insights can inform the design and implementation of the technology. %M 36961491 %R 10.2196/43781 %U https://cardio.jmir.org/2023/1/e43781 %U https://doi.org/10.2196/43781 %U http://www.ncbi.nlm.nih.gov/pubmed/36961491 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e39894 %T Moral Elevation Online Intervention for Veterans Experiencing Distress Related to Posttraumatic Stress Disorder and Moral Injury (MOVED): Pilot Trial of a 4-Week Positive Psychology Web-Based Intervention %A McGuire,Adam P %A Howard,Binh An Nguyen %A Erickson,Thane M %A Creech,Suzannah K %+ VISN 17 Center of Excellence for Research on Returning War Veterans, 4800 Memorial Dr #151c, Waco, TX, 76711, United States, 1 254 297 5155, adam.mcguire@va.gov %K moral elevation %K web-based intervention %K pilot study %K veterans %K posttraumatic stress disorder %K PTSD %K moral injury %D 2023 %7 24.3.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Veterans with posttraumatic stress disorder (PTSD) and moral injury can encounter several barriers to treatment, including limited access to care and low engagement with therapy. Furthermore, most treatment approaches focus on alleviating distress rather than cultivating positive experiences that could facilitate trauma recovery. A potential way to address these issues is through moral elevation: feeling uplifted and inspired by others’ virtuous actions. Objective: This study aimed to examine the feasibility and acceptability of a novel, web-based moral elevation intervention for veterans with PTSD symptoms and moral injury distress (Moral Elevation Online Intervention for Veterans Experiencing Distress Related to PTSD and Moral Injury [MOVED]). This mixed methods study also examined potential changes in PTSD symptoms, moral injury distress, quality of life, and prosocial behavior. Methods: In this pilot trial, 48 participants were randomized to a MOVED or control condition (24 participants per condition). Both conditions included 8 sessions and lasted 1 month. The MOVED intervention and all survey components across both conditions were administered online. Participants completed self-report measures that assessed PTSD symptoms, moral injury distress, quality of life, and prosocial behavior at baseline and follow-up. Veterans in the MOVED condition also completed individual qualitative interviews at follow-up. We coded qualitative responses to interviews and identified emergent themes. Results: Findings suggest the MOVED intervention was largely feasible, with evidence for moderate-to-high levels of participation, engagement, and retention in MOVED sessions. Both quantitative and qualitative results suggest veterans found MOVED to be acceptable and satisfactory at the overall treatment level. Furthermore, participants reported high scores for helpfulness and engagement at the session level. Veterans who completed MOVED reported large within-person decreases in PTSD symptoms (Cohen d=1.44), approximately twice that of veterans in the control condition (Cohen d=0.78). Those in MOVED also reported medium-sized increases in physical (Cohen d=0.71) and psychological domains of quality of life (Cohen d=0.74), compared with no meaningful changes in the control condition. Unexpectedly, MOVED veterans reported no decrease in moral injury distress, whereas veterans in the control condition endorsed a medium-sized decrease in the total score. There were no changes in prosociality for either condition. Qualitative feedback further supported high levels of perceived acceptability and satisfaction and positive treatment outcomes across a range of domains, including behaviors, cognitions, emotions, and social functioning. Veterans also recommended adaptations to enhance engagement and maximize the impact of intervention content. Conclusions: Overall, findings indicate that veterans with PTSD and moral injury distress were interested in an intervention based on exposure to and engagement with experiences of moral elevation. After further research and refinement guided by future trials, veterans may benefit from this novel approach, which may enhance treatment outcomes and increase treatment accessibility for those in need of additional trauma-focused care. %M 36961494 %R 10.2196/39894 %U https://formative.jmir.org/2023/1/e39894 %U https://doi.org/10.2196/39894 %U http://www.ncbi.nlm.nih.gov/pubmed/36961494 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e36562 %T Effects of Mobile-Based Financial Incentive Interventions for Adults at Risk of Developing Hypertension: Feasibility Randomized Controlled Trial %A Willms,Amanda %A Rhodes,Ryan E %A Liu,Sam %+ School of Exercise Science, Physical and Health Education, University of Victoria, PO Box 3010 STN CSC, Victoria, BC, V8W 2Y2, Canada, 1 250 721 8392, awillms@uvic.ca %K mHealth %K physical activity %K financial incentive %K hypertension %K mobile health %K exercise %K lifestyle health %K cardiovascular disease %K mortality %K heart disease %K incentive %K motivation %D 2023 %7 24.3.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Hypertension is the leading modifiable risk factor for cardiovascular disease and mortality. Adopting lifestyle modifications, like increasing physical activity (PA), can be an effective strategy in blood pressure (BP) control, but many adults do not meet the PA guidelines. Financial incentive interventions have the power to increase PA levels but are often limited due to cost. Further, mobile health technologies can make these programs more scalable. There is a gap in the literature about the most feasible and effective financial incentive PA framework; thus, pay-per-minute (PPM) and self-funded investment incentive (SFII) frameworks were explored. Objective: The aims were to (1) determine the feasibility (recruitment, engagement, and acceptability) of an 8-week mobile-based PPM and SFII hypertension prevention PA program and (2) explore the effects of PPM and SFII interventions relative to a control on the PA levels, BP, and PA motivation. Methods: In total, 55 adults aged 40-65 years not meeting the Canadian PA guidelines were recruited from Facebook and randomized into the following groups: financial incentive groups, PPM or SFII, receiving up to CAD $20 each (at the time of writing: CAD $1=US $0.74), or a control group without financial incentive. PPM participants received CAD $0.02 for each minute of moderate-to-vigorous PA (MVPA) per week up to the PA guidelines and the SFII received CAD $2.50 for each week they met the PA guidelines. Feasibility outcome measures (recruitment, engagement, and acceptability) were assessed. Secondary outcomes included changes in PA outcomes (MVPA and daily steps) relative to baseline were compared among PPM, SFII, and control groups at 4 and 8 weeks using linear regressions. Changes in BP and relative autonomy index relative to baseline were compared among the groups at follow-up. Results: Participants were randomized to the PPM (n=19), SFII (n=18), or control (n=18) groups. The recruitment, retention rate, and engagement were 77%, 75%, and 65%, respectively. The intervention received overall positive feedback, with 90% of comments praising the intervention structure, financial incentive, and educational materials. Relative to the control at 4 weeks, the PPM and SFII arms increased their MVPA with medium effect (PPM vs control: η2p=0.06, mean 117.8, SD 514 minutes; SFII vs control: η2p=0.08, mean 145.3, SD 616 minutes). At 8 weeks, PPM maintained a small effect in MVPA relative to the control (η2p=0.01, mean 22.8, SD 249 minutes) and SFII displayed a medium effect size (η2p=0.07, mean 113.8, SD 256 minutes). Small effects were observed for PPM and SFII relative to the control for systolic blood pressure (SBP) and diastolic blood pressure (DBP) (PPM: η2p=0.12, Δmean SBP 7.1, SD 23.61 mm Hg; η2p=0.04, Δmean DBP 3.5, SD 6.2 mm Hg; SFII: η2p=0.01, Δmean SBP −0.4, SD 1.4 mm Hg; η2p=0.02, Δmean DBP −2.3, SD 7.7 mm Hg) and relative autonomy index (PPM: η2p=0.01; SFII: η2p=0.03). Conclusions: The feasibility metrics and preliminary findings suggest that a future full-scale randomized controlled trial examining the efficacy of PPM and SFII relative to a control is feasible, and studies with longer duration are warranted. %M 36961486 %R 10.2196/36562 %U https://formative.jmir.org/2023/1/e36562 %U https://doi.org/10.2196/36562 %U http://www.ncbi.nlm.nih.gov/pubmed/36961486 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e39024 %T Health Literate Internet-Based Information-Seeking Processes: Theory-Based Development of a Conceptual Model %A Heiberger,Andrea %A Dresch,Carolin %A Schulz,Anja Alexandra %A Wirtz,Markus Antonius %+ Research Methods in Health Sciences, Faculty of Mathematics, Natural Sciences and Technology, University of Education Freiburg, Kunzenweg 21, Freiburg im Breisgau, 79117, Germany, 49 761 682624, andrea.heiberger@ph-freiburg.de %K health literacy %K internet-based search %K model development %K parents %K health information %K internet %K childhood %K allergy %K prevention %K pediatric %K online %K content %K information %D 2023 %7 23.3.2023 %9 Research Letter %J J Med Internet Res %G English %X %M 36951897 %R 10.2196/39024 %U https://www.jmir.org/2023/1/e39024 %U https://doi.org/10.2196/39024 %U http://www.ncbi.nlm.nih.gov/pubmed/36951897 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e38504 %T A Web-Based Stratified Stepped Care Platform for Mental Well-being (TourHeart+): User-Centered Research and Design %A Mak,Winnie W S %A Ng,Sin Man %A Leung,Florence H T %+ Department of Psychology, The Chinese University of Hong Kong, Shatin, Hong Kong, 852 39436577, wwsmak@cuhk.edu.hk %K user-centered design %K qualitative research %K usability testing %K mental health %K self-care %K stratified stepped care %K internet-based psychological interventions %D 2023 %7 22.3.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Internet-based mental health interventions have been demonstrated to be effective in alleviating psychological distress and promoting mental well-being. However, real-world uptake and engagement of such interventions have been low. Rather than being stand-alone interventions, situating internet-based interventions under a stratified stepped care system can support users to continue with mental health practice and monitor their mental health status for timely services that are commensurate with their needs. A user-centered approach should be used in the development of such web-based platforms to understand the facilitators and barriers in user engagement to enhance platform uptake, usability, and adherence so it can support the users’ continued adoption and practice of self-care for their mental health. Objective: The aim of this study was to describe the design process taken to develop a web-based stratified stepped care mental health platform, TourHeart+, using a user-centered approach that gathers target users’ perceptions on mental self-care and feedback on the platform design and incorporates them into the design. Methods: The process involved a design workshop with the interdisciplinary development team, user interviews, and 2 usability testing sessions on the flow of registration and mental health assessment and the web-based self-help interventions of the platform. The data collected were summarized as descriptive statistics if appropriate and insights are extracted inductively. Qualitative data were extracted using a thematic coding approach. Results: In the design workshop, the team generated empathy maps and point-of-view statements related to the possible mental health needs of target users. Four user personas and related processes in the mental health self-care journey were developed based on user interviews. Design considerations were derived based on the insights drawn from the personas and mental health self-care journey. Survey results from 104 users during usability testing showed that the overall experience during registration and mental health assessment was friendly, and they felt cared for, although no statistically significant differences on preference ratings were found between using a web-based questionnaire tool and through an interactive chatbot, except that chatbot format was deemed more interesting. Facilitators of and barriers to registering the platform and completing the mental health assessment were identified through user feedback during simulation with mock-ups. In the usability testing for guided self-help interventions, users expressed pain points in course adherence, and corresponding amendments were made in the flow and design of the web-based courses. Conclusions: The design process and findings presented in the study are important in developing a user-centric platform to optimize users’ acceptance and usability of a web-based stratified stepped care platform with guided self-help interventions for mental well-being. Accounting for users’ perceptions and needs toward mental health self-care and their experiences in the design process can enhance the usability of an evidence-based mental health platform on the web. %M 36947112 %R 10.2196/38504 %U https://formative.jmir.org/2023/1/e38504 %U https://doi.org/10.2196/38504 %U http://www.ncbi.nlm.nih.gov/pubmed/36947112 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e39052 %T Effectiveness of an App-Based Short Intervention to Improve Sleep: Randomized Controlled Trial %A Vollert,Bianka %A Müller,Luise %A Jacobi,Corinna %A Trockel,Mickey %A Beintner,Ina %+ Department of Clinical Psychology and Psychotherapy, Faculty of Psychology, Technische Universität Dresden, Chemnitzer Strasse 46, Dresden, 01187, Germany, 49 351 463 38576, bianka.vollert@tu-dresden.de %K sleep %K insomnia %K cognitive behavioral treatment for insomnia %K eHealth %K mobile app %D 2023 %7 21.3.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: A growing body of evidence for digital interventions to improve sleep shows promising effects. The interventions investigated so far have been primarily web-based; however, app-based interventions may reach a wider audience and be more suitable for daily use. Objective: This study aims to evaluate the intervention effects, adherence, and acceptance of an unguided app-based intervention for individuals who wish to improve their sleep. Methods: In a randomized controlled trial, we evaluated the effects of an app-based short intervention (Refresh) to improve sleep compared with a waitlist condition. Refresh is an 8-week unguided intervention covering the principles of cognitive behavioral therapy for insomnia (CBT-I) and including a sleep diary. The primary outcome was sleep quality (insomnia symptoms) as self-assessed by the Regensburg Insomnia Scale (RIS). The secondary outcomes were depression (9-item Patient Health Questionnaire [PHQ-9] score) and perceived insomnia-related impairment. Results: We included 371 participants, of which 245 reported poor sleep at baseline. About 1 in 3 participants who were allocated to the intervention group never accessed the intervention. Active participants completed on average 4 out of 8 chapters. Retention rates were 67.4% (n=250) at postassessment and 57.7% (n=214) at the 6-month follow-up. At postintervention, insomnia symptoms in the intervention group had improved more than those in the waitlist group, with a small effect (d=0.26) in the whole sample and a medium effect (d=0.45) in the subgroup with poor sleep. Effects in the intervention group were maintained at follow-up. Perceived insomnia-related impairment also improved from pre- to postassessment. No significant intervention effect on depression was detected. Working alliance and acceptance were moderate to good. Conclusions: An app-based, unguided intervention is a feasible and effective option to scale-up CBT-I-based treatment, but intervention uptake and adherence need to be carefully addressed. Trial Registration: ISRCTN Registry ISRCTN53553517; https://www.isrctn.com/ISRCTN53553517 %M 36943337 %R 10.2196/39052 %U https://mental.jmir.org/2023/1/e39052 %U https://doi.org/10.2196/39052 %U http://www.ncbi.nlm.nih.gov/pubmed/36943337 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44725 %T A Pilot of Digital Whiteboards for Improving Patient Satisfaction in the Emergency Department: Nonrandomized Controlled Trial %A Marshall,Andrew D A %A Hasdianda,Mohammad Adrian %A Miyawaki,Steven %A Jambaulikar,Guruprasad D %A Cao,Chenze %A Chen,Paul %A Baugh,Christopher W %A Zhang,Haipeng %A McCabe,Jonathan %A Steinbach,Lee %A King,Scott %A Friedman,Jason %A Su,Jennifer %A Landman,Adam B %A Chai,Peter Ray %+ Department of Emergency Medicine, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, United States, 1 6159448967, amarshall8@bwh.harvard.edu %K digital whiteboard %K digital intervention %K health technology %K electronic paper %K E-paper %K patient satisfaction %K communication %K emergency department experience %K experience %K emergency %K hospital %K satisfaction %K patient facing software %K infrastructure %K patient care %K emergency department %K patient communication %K hospital setting %K patient experience %K perception %K match pair %K statistics %K user experience %K learning %K Media and Technology Usage and Attitudes Scale %K MTUAS %K user interface %K interface %K design %K Likert %K Wilcoxon rank %K Wilcox %K exploratory data analysis %K EDA %K x^2 %K x2 %D 2023 %7 21.3.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Electronic paper (E-paper) screens use electrophoretic ink to provide paper-like low-power displays with advanced networking capabilities that may potentially serve as an alternative to traditional whiteboards and television display screens in hospital settings. E-paper may be leveraged in the emergency department (ED) to facilitate communication. Providing ED patient status updates on E-paper screens could improve patient satisfaction and overall experience and provide more equitable access to their health information. Objective: We aimed to pilot a patient-facing digital whiteboard using E-paper to display relevant orienting and clinical information in real time to ED patients. We also sought to assess patients’ satisfaction after our intervention and understand our patients’ overall perception of the impact of the digital whiteboards on their stay. Methods: We deployed a 41-inch E-paper digital whiteboard in 4 rooms in an urban, tertiary care, and academic ED and enrolled 110 patients to understand and evaluate their experience. Participants completed a modified Hospital Consumer Assessment of Health Care Provider and Systems satisfaction questionnaire about their ED stay. We compared responses to a matched control group of patients triaged to ED rooms without digital whiteboards. We designed the digital whiteboard based on iterative feedback from various departmental stakeholders. After establishing IT infrastructure to support the project, we enrolled patients on a convenience basis into a control and an intervention (digital whiteboard) group. Enrollees were given a baseline survey to evaluate their comfort with technology and an exit survey to evaluate their opinions of the digital whiteboard and overall ED satisfaction. Statistical analysis was performed to compare baseline characteristics as well as satisfaction. Results: After the successful prototyping and implementation of 4 digital whiteboards, we screened 471 patients for inclusion. We enrolled 110 patients, and 50 patients in each group (control and intervention) completed the study protocol. Age, gender, and racial and ethnic composition were similar between groups. We saw significant increases in satisfaction on postvisit surveys when patients were asked about communication regarding delays (P=.03) and what to do after discharge (P=.02). We found that patients in the intervention group were more likely to recommend the facility to family and friends (P=.04). Additionally, 96% (48/50) stated that they preferred a room with a digital whiteboard, and 70% (35/50) found the intervention “quite a bit” or “extremely” helpful in understanding their ED stay. Conclusions: Digital whiteboards are a feasible and acceptable method of displaying patient-facing data in the ED. Our pilot suggested that E-paper screens coupled with relevant, real-time clinical data and packaged together as a digital whiteboard may positively impact patient satisfaction and the perception of the facility during ED visits. Further study is needed to fully understand the impact on patient satisfaction and experience. Trial Registration: ClinicalTrials.gov NCT04497922; https://clinicaltrials.gov/ct2/show/NCT04497922 %M 36943360 %R 10.2196/44725 %U https://formative.jmir.org/2023/1/e44725 %U https://doi.org/10.2196/44725 %U http://www.ncbi.nlm.nih.gov/pubmed/36943360 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e44542 %T Exploring the Perceptions of mHealth Interventions for the Prevention of Common Mental Disorders in University Students in Singapore: Qualitative Study %A Salamanca-Sanabria,Alicia %A Jabir,Ahmad Ishqi %A Lin,Xiaowen %A Alattas,Aishah %A Kocaballi,A Baki %A Lee,Jimmy %A Kowatsch,Tobias %A Tudor Car,Lorainne %+ Lee Kong Chian School of Medicine, Nanyang Technological University, 11 Mandalay Road, Level 18, Singapore, 308232, Singapore, 65 69041258, lorainne.tudor.car@ntu.edu.sg %K interventions %K students %K mobile health %K mHealth %K mental health %K mental disorders %K university %K common mental disorders %K anxiety %K depression %D 2023 %7 20.3.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Mental health interventions delivered through mobile health (mHealth) technologies can increase the access to mental health services, especially among university students. The development of mHealth intervention is complex and needs to be context sensitive. There is currently limited evidence on the perceptions, needs, and barriers related to these interventions in the Southeast Asian context. Objective: This qualitative study aimed to explore the perception of university students and mental health supporters in Singapore about mental health services, campaigns, and mHealth interventions with a focus on conversational agent interventions for the prevention of common mental disorders such as anxiety and depression. Methods: We conducted 6 web-based focus group discussions with 30 university students and one-to-one web-based interviews with 11 mental health supporters consisting of faculty members tasked with student pastoral care, a mental health first aider, counselors, psychologists, a clinical psychologist, and a psychiatrist. The qualitative analysis followed a reflexive thematic analysis framework. Results: The following 6 main themes were identified: a healthy lifestyle as students, access to mental health services, the role of mental health promotion campaigns, preferred mHealth engagement features, factors that influence the adoption of mHealth interventions, and cultural relevance of mHealth interventions. The interpretation of our findings shows that students were reluctant to use mental health services because of the fear of stigma and a possible lack of confidentiality. Conclusions: Study participants viewed mHealth interventions for mental health as part of a blended intervention. They also felt that future mental health mHealth interventions should be more personalized and capable of managing adverse events such as suicidal ideation. %M 36939808 %R 10.2196/44542 %U https://www.jmir.org/2023/1/e44542 %U https://doi.org/10.2196/44542 %U http://www.ncbi.nlm.nih.gov/pubmed/36939808 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42896 %T Influence of Internet-Based Health Management on Control of Clinical Parameters in Patients With Hypertension: Four-Year Longitudinal Study %A Chen,Botian %A Dou,Yuqi %A Yu,Xue %A Ma,Defu %+ School of Public Health, Peking University Health Science Center, 38 Xueyuan Road, Haidian District, Beijing, 100191, China, 86 13522424856, madefu@bjmu.edu.cn %K hypertension %K internet-based health management %K blood pressure control %K longitudinal study %K health management %K primary care %K online based %K eHealth %K telehealth %K telemedicine %D 2023 %7 20.3.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: In recent years, more and more studies have shown that internet-based health management can help patients with hypertension control their blood pressure. However, there is a lack of similar research in China. Objective: We designed this study to clarify the impact of long-term internet-based health management on the control of clinical parameters in patients with hypertension. These results are also expected to identify the relevant factors affecting the control of clinical parameters in hypertension more accurately toward developing more targeted health management strategies. Methods: This was a longitudinal study of internet-based health management in the five provinces of northwest China. The inclusion criteria were aged ≥18 years and no serious cognitive disease or mental disorder. After collecting the physical examination data of 8567 people in the five northwest provinces in 2013, we conducted online health management (including diet, exercise, and behavior) and follow-up. In the physical examination in 2013, 1008 new patients with hypertension were identified, who were divided into a good blood pressure control group and poor blood pressure control group. Physical examination and a questionnaire survey were conducted every 2 years to understand the changes of health management on the subjects’ health-related behaviors. We then analyzed the changes of clinical indicators related to hypertension and the influencing factors related to blood pressure control in patients with hypertension. All statistical analyses were performed using R software (version 4.1.2) and a P value <.05 was considered statistically significant. Results: A total of 8567 people met the inclusion criteria and underwent health management. Self-comparison showed that after 4 years of health management, the smoking cessation rate and amount of exercise significantly increased (both P<.001). The low-density lipoprotein-cholesterol levels also increased (P=.005), whereas the high-density lipoprotein-cholesterol levels decreased (P=.007). The newly discovered patients with hypertension in 2013 were further screened. After 4 years of health management, their smoking cessation rate increased significantly (P=.03) and the amount of exercise increased but not significantly (P=.08). In terms of clinical indicators, the diastolic blood pressure considerably decreased (P<.001) and the systolic blood pressure slightly decreased (P=.13). The correlation analysis of blood pressure control in patients with new-onset hypertension showed that gender (female) and changing relevant factors according to health management behaviors (BMI; cereals and potatoes intake; fish, livestock meat, and eggs intake; fruit intake; and physical activity) were the protective factors of blood pressure control. Conclusions: Internet-based health management has a significant and long-term effect on blood pressure control in patients with hypertension. %M 36939826 %R 10.2196/42896 %U https://www.jmir.org/2023/1/e42896 %U https://doi.org/10.2196/42896 %U http://www.ncbi.nlm.nih.gov/pubmed/36939826 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e43066 %T Effectiveness of Digital Mental Health Tools to Reduce Depressive and Anxiety Symptoms in Low- and Middle-Income Countries: Systematic Review and Meta-analysis %A Kim,Jiyeong %A Aryee,Lois M D %A Bang,Heejung %A Prajogo,Steffi %A Choi,Yong K %A Hoch,Jeffrey S %A Prado,Elizabeth L %+ Department of Public Health Sciences, School of Medicine, University of California, Davis, 1 Shields Avenue, Davis, CA, 95616, United States, 1 5307522793, jiykim@ucdavis.edu %K digital mental health %K mHealth %K mobile health %K digital health %K low- and middle-income country %K depression %K anxiety %K mobile phone %D 2023 %7 20.3.2023 %9 Review %J JMIR Ment Health %G English %X Background: Depression and anxiety contribute to an estimated 74.6 million years of life with disability, and 80% of this burden occurs in low- and middle-income countries (LMICs), where there is a large gap in care. Objective: We aimed to systematically synthesize available evidence and quantify the effectiveness of digital mental health interventions in reducing depression and anxiety in LMICs. Methods: In this systematic review and meta-analysis, we searched PubMed, Embase, and Cochrane databases from the inception date to February 2022. We included randomized controlled trials conducted in LMICs that compared groups that received digital health interventions with controls (active control, treatment as usual, or no intervention) on depression or anxiety symptoms. Two reviewers independently extracted summary data reported in the papers and performed study quality assessments. The outcomes were postintervention measures of depression or anxiety symptoms (Hedges g). We calculated the pooled effect size weighted by inverse variance. Results: Among 11,196 retrieved records, we included 80 studies in the meta-analysis (12,070 participants n=6052, 50.14% in the intervention group and n=6018, 49.85% in the control group) and 96 studies in the systematic review. The pooled effect sizes were −0.61 (95% CI −0.78 to −0.44; n=67 comparisons) for depression and −0.73 (95% CI −0.93 to −0.53; n=65 comparisons) for anxiety, indicating that digital health intervention groups had lower postintervention depression and anxiety symptoms compared with controls. Although heterogeneity was considerable (I2=0.94 for depression and 0.95 for anxiety), we found notable sources of variability between the studies, including intervention content, depression or anxiety symptom severity, control type, and age. Grading of Recommendations, Assessments, Development, and Evaluation showed that the evidence quality was overall high. Conclusions: Digital mental health tools are moderately to highly effective in reducing depression and anxiety symptoms in LMICs. Thus, they could be effective options to close the gap in depression and anxiety care in LMICs, where the usual mental health care is minimal. Trial Registration: PROSPERO CRD42021289709; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=289709 %M 36939820 %R 10.2196/43066 %U https://mental.jmir.org/2023/1/e43066 %U https://doi.org/10.2196/43066 %U http://www.ncbi.nlm.nih.gov/pubmed/36939820 %0 Journal Article %@ 2562-0959 %I JMIR Publications %V 6 %N %P e42360 %T A Digital Self-help Intervention for Atopic Dermatitis: Analysis of Secondary Outcomes From a Feasibility Study %A Kern,Dorian %A Ljótsson,Brjánn %A Lönndahl,Louise %A Hedman-Lagerlöf,Erik %A Bradley,Maria %A Lindefors,Nils %A Kraepelien,Martin %+ Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Norra Stationsgatan 69, Stockholm, 11364, Sweden, 46 723243235, dorian.kern@ki.se %K atopic dermatitis %K eczema %K pruritus %K cognitive behavioral therapy %K CBT %K dermatitis %K skin %K dermatology %K self-management %K self-guided %K self-help %K digital health %K digital intervention %K stress %K depressive %K depression %K mental health %D 2023 %7 20.3.2023 %9 Original Paper %J JMIR Dermatol %G English %X Background: Atopic dermatitis (AD) is a common inflammatory skin disease characterized by dry skin, eczematous lesions, and an often severe pruritus. The disease may have a negative effect on quality of life and is also associated with symptoms of anxiety and depression. Few individuals with AD receive any form of behavioral intervention. Behavioral interventions for AD are potentially efficacious but need to be constructed so that they are safe, credible, and user-friendly. We have previously reported on a feasibility study that demonstrated that a self-management version of a digital intervention based on cognitive behavioral therapy (CBT) for AD can potentially be effective in reducing AD symptoms. The aim of this secondary report was to further examine treatment feasibility and preliminary effects on dermatological quality of life, itching sensations, depressive symptoms, and perceived stress. Objective: This is a secondary report on intervention credibility, usability, adverse events, and preliminary effects on secondary measures of a self-management digital intervention for atopic dermatitis. Methods: In total, 21 adults with AD, recruited nationwide in Sweden, were assessed by telephone, and used the digital intervention for 8 weeks. Participants were also assessed directly afterward and 3 months after the end of the intervention. There was no therapist guidance. Feasibility indicators included intervention credibility, usability, and possible adverse effects. Other measures included preliminary effects on dermatological quality of life, itching sensations, depressive symptoms, and perceived stress. Results: The intervention was regarded as credible and no serious adverse events were reported. System usability was, however, found to be below the predetermined cutoff for acceptable usability. Preliminary effects at 3-month follow-up were in the moderate to large range for dermatological quality of life (Cohen d=0.89, 95% CI 0.18-1.56), itching sensations (Cohen d=0.85, 95% CI 0.15-1.52), depressive symptoms (Cohen d=0.78, 95% CI 0.1-1.45), and perceived stress (Cohen d=0.75, 95% CI 0.01-1.36). Conclusions: This 8-week self-management digital CBT-based intervention was, together with telephone calls before and after, a feasible intervention for participants with AD. Preliminary effects were promising and should be explored further in a randomized controlled trial. Intervention usability was, however, rated below cutoff scores. Efforts should be made to improve written material to increase usability. %M 37632924 %R 10.2196/42360 %U https://derma.jmir.org/2023/1/e42360 %U https://doi.org/10.2196/42360 %U http://www.ncbi.nlm.nih.gov/pubmed/37632924 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42776 %T The Usefulness of a Smartphone App–Based Smoking Cessation Program for Conventional Cigarette Users, Heated Tobacco Product Users, and Dual Users: Retrospective Study %A Noda,Yuko %A So,Ryuhei %A Sonoda,Misaki %A Tabuchi,Takahiro %A Nomura,Akihiro %+ Department of Biomedical Informatics, CureApp Institute, 4136-1 Azayakozawa, Nagakura, Karuizawa, 389-0111, Japan, 81 9087019830, akihiro.nomura@cureapp.institute %K smoking cessation %K nicotine dependence %K digital therapeutics %K telemedicine %K telecare %K mobile phone %K smoking cessation program %K online counseling %K online therapy %K heated tobacco product %K HTP %D 2023 %7 17.3.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Heated tobacco products (HTPs) are widespread in Japan, and smoking cessation of such products has become an important issue owing to the spread of harmful effects from HTPs. The efficacy of online digital therapy has been reported in smoking cessation treatment; however, we have limited evidence of online smoking cessation programs for HTP users. Objective: In this study, we evaluate the usefulness of the Ascure program for HTP users (defined as exclusive HTP use or dual use of HTP and cigarettes) compared with exclusive cigarette users. Methods: This was a retrospective study. We recruited adult smokers participating in the Ascure online smoking cessation program in Japan from June 2019 to February 2021. The Ascure smartphone app provided four elements: (1) educational video tutorials to enhance the understanding of nicotine dependence, (2) a personalized to-do list for behavior change, (3) a digital diary for record keeping, and (4) interactive chat sessions for relief from cravings or withdrawal symptoms. The primary outcome was the continuous abstinence rate (CAR) at weeks 21 to 24, biochemically validated using salivary cotinine testing. We considered those who dropped out of the program as smoking cessation failures. We analyzed the primary outcome using inverse probability weighting against tobacco product type estimated by multinomial propensity scores. We also assessed CAR at weeks 9 to 12 and program adherence. Results: We analyzed data from 2952 participants, including 52% (1524/3478) in the cigarette group, 35% (1038/3478) in the HTP group, and 13% (390/3478) in the dual-use group, who had a mean age of 43.4 (SD 10.8) years and included 17% (513/2952) women. CAR at weeks 21 to 24 showed that exclusive HTP users were more likely to stop tobacco use than exclusive cigarette smokers (CAR 52.6% for cigarette users vs CAR 64.8% for HTP users; odds ratio [OR] 1.17, 95% CI 1.12-1.22; P<.001). There was no significant difference between the exclusive cigarette users and the dual users (CAR 52.6% for cigarette users vs CAR 48.7% for dual users; OR 0.99, 95% CI 0.93-1.05; P=.77). CAR at weeks 9 to 12 was 56.7% (95% CI 54.2%-59.2%) for the exclusive cigarette users, 68.3% (95% CI 65.5%-71.1%) for the exclusive HTP users, and 58.2% (95% CI 53.3%-63.1%) for the dual users. The program adherence rate at week 24 was 70.7% overall (68.4% for cigarette users, 75% for HTP users, and 67.9% for dual users). Conclusions: Exclusive HTP users had higher CARs and adherence compared with exclusive cigarette users, indicating a higher affinity for the Ascure online smoking cessation program. This program might be a useful smoking cessation option for HTP users, as well as for cigarette smokers. %M 36930197 %R 10.2196/42776 %U https://www.jmir.org/2023/1/e42776 %U https://doi.org/10.2196/42776 %U http://www.ncbi.nlm.nih.gov/pubmed/36930197 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e39253 %T The Efficacy of Be a Mom, a Web-Based Intervention to Prevent Postpartum Depression: Examining Mechanisms of Change in a Randomized Controlled Trial %A Carona,Carlos %A Pereira,Marco %A Araújo-Pedrosa,Anabela %A Canavarro,Maria Cristina %A Fonseca,Ana %+ Center for Research in Neuropsychology and Cognitive-Behavioral Intervention, University of Coimbra, Colégio Novo St., Coimbra, 3000-115, Portugal, 351 239851450, ccarona@fpce.uc.pt %K Be a Mom %K randomized controlled trial %K postpartum depression %K web-based interventions %K cognitive behavioral therapy %K prevention %K mobile phone %D 2023 %7 17.3.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Postpartum depression (PPD) is treatable and preventable, but most women do not seek professional help for their perinatal depressive symptoms. One increasingly popular approach of improving access to care is the use of web-based intervention programs. Objective: The objective of this study was 2-fold: first, to assess the efficacy of Be a Mom, a brief web-based selective or indicated preventive intervention, in reducing depressive and anxiety symptoms of women at high risk for PPD; and second, to examine mechanisms of change linking modifiable self-regulatory skills (ie, emotion regulation, self-compassion, and psychological flexibility) to improved perinatal mental health outcomes. Methods: This 2-arm, open-label randomized controlled trial involved a sample of 1053 perinatal women presenting high risk for PPD who were allocated to the Be a Mom intervention group or a waitlist control group and completed self-report measures at baseline and postintervention assessments. Univariate latent change score models were computed to determine changes over time in adjustment processes and outcomes, with a multigroup-model approach to detect differences between the intervention and control groups and a 2-wave latent change score model to examine whether changes in processes were related to changes in outcomes. Results: Be a Mom was found to be effective in reducing depressive (intervention group: µΔ=–3.35; P<.001 vs control group: µΔ=–1.48; P<.001) and anxiety symptoms (intervention group: µΔ=–2.24; P<.001 vs control group: µΔ=–0.43; P=.04) in comparison with the control group, where such changes were inexistent or much smaller. All 3 psychological processes under study improved statistically significantly in posttreatment assessments: emotion regulation ability (Δχ23=12.3; P=.007) and psychological flexibility (Δχ23=34.9; P<.001) improved only in the intervention group, and although self-compassion increased in both groups (Δχ23=65.6; P<.001), these improvements were considerably greater in the intervention group. Conclusions: These results suggest that Be a Mom, a low-intensity cognitive behavioral therapy program, is a promising first-line intervention for helping perinatal women, particularly those with early-onset PPD symptoms. Trial Registration: ClinicalTrials.gov NCT03024645; https://clinicaltrials.gov/ct2/show/NCT03024645 %M 36930182 %R 10.2196/39253 %U https://mental.jmir.org/2023/1/e39253 %U https://doi.org/10.2196/39253 %U http://www.ncbi.nlm.nih.gov/pubmed/36930182 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43600 %T Clinical and Psychosocial Outcomes Associated With a Tele-behavioral Health Platform for Families: Retrospective Study %A Loo,Theoren %A Hunt,Justin %A Grodberg,David %A Bravata,Dena %+ Child Study Center, Yale University School of Medicine, 333 Cedar St, New Haven, CT, 06510, United States, 1 203 785 2513, david.grodberg@yale.edu %K adolescent %K child %K family health %K resilience, psychological %K mental health %K caregiver stress %K anxiety %K depression %K behavior %K program %K educational psychotherapy %K psychiatry %K care %D 2023 %7 17.3.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The burden of pediatric mental illness in the United States has steadily worsened over the past decade. A recent increase in employer-sponsored behavioral health programs has focused on the needs of the general population. However, these programs do not provide the specialty mental health care required for children, adolescents, and their families. Objective: This study aimed to evaluate the effects of a technology-enabled pediatric and family behavioral health service on clinical outcomes among children and caregiver strain. The service is available to commercially insured populations and provides educational content; tele-behavioral health care, including coaching, therapy, and psychiatry; and care escalation and coordination. Methods: A retrospective cohort analysis of members using the service between February and September 2022 was conducted. Clinical outcomes for children and their caregivers were collected using the Pediatric Symptom Checklist-17 (PSC-17), Generalized Anxiety Disorder 7-item (GAD-7), Patient Health Questionnaire 8-item (PHQ-8), and Caregiver Strain Questionnaire-Short Form 7 (CGSQ-SF7). Rates of reliable improvement were determined by calculating the reliable change index for each outcome. Paired, 2-tailed t tests were used to evaluate significant changes in assessment scores at follow-up compared to baseline. Results: Of the 4139 participants who enrolled with the service, 48 (1.2%) were referred out for more intensive care, 2393 (57.8%) were referred to coaching, and 1698 (41%) were referred to therapy and psychiatry. Among the 703 members who completed the intervention and provided pre- and postintervention outcomes data, 386 (54.9%) used psychoeducational content, 345 (49.1%) received coaching, and 358 (50.9%) received therapy and psychiatry. In coaching, 75% (183/244) of participants showed reliable improvement on the PSC-17 total score, 72.5% (177/244) on the PSC-17 internalizing score, and 31.5% (105/333) on the CGSQ-SF7 total score (average improvement: PSC-17 total score, 3.37 points; P<.001; PSC-17 internalizing score, 1.58 points; P<.001; and CGSQ-SF7 total score, 1.02 points; P<.001). In therapy and psychiatry, 68.8% (232/337) of participants showed reliable improvement on the PSC-17 total score, 70.6% (238/337) on the PSC-17 internalizing score, 65.2% (219/336) on the CGSQ-SF7 total score, 70.7% (82/116) on the GAD-7 score, and 67.5% (77/114) on the PHQ-8 score (average improvement: PSC-17 total score, 3.16 points; P<.001; PSC-17 internalizing score, 1.66 points; P<.001; CGSQ-SF7 total score, 1.06 points; P<.001; GAD-7 score, 3.00 points; P<.001; and PHQ-8 score, 2.91 points; P<.001). Conclusions: Tele-behavioral health offerings can be effective in improving caregiver strain and psychosocial functioning and depression and anxiety symptoms in a pediatric population. Moreover, these digital mental health offerings may provide a scalable solution to children and their families who lack access to essential pediatric mental health services. %M 36930214 %R 10.2196/43600 %U https://formative.jmir.org/2023/1/e43600 %U https://doi.org/10.2196/43600 %U http://www.ncbi.nlm.nih.gov/pubmed/36930214 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41758 %T Examination of Web-Based Single-Session Growth Mindset Interventions for Reducing Adolescent Anxiety: Study Protocol of a 3-Arm Cluster Randomized Controlled Trial %A Zhu,Shimin %A Tse,Samson %A Chan,Ko Ling %A Lee,Paul %A Cheng,Qijin %A Sun,Jessica %+ Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong, 852 2766 5787, jasmine.zhu@polyu.edu.hk %K growth mindset %K fixed mindset %K mental health %K secondary school students, brief intervention, belief-in-change %D 2023 %7 17.3.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Anxiety disorders are the most common mental disorders worldwide. In Hong Kong, 7% of adolescents are diagnosed with anxiety disorders, and 1 in every 4 secondary school students reports clinical-level anxiety symptoms. However, 65% of them do not access services. Long waitlists in public services, the high cost of private services, or the fear of being stigmatized can hinder service access. The high prevalence of anxiety and low intervention uptake indicate a pressing need to develop timely, scalable, and potent interventions suitable for adolescents. Single-session interventions (SSIs) have the potential to be scalable interventions for diagnosable or subclinical psychopathology in adolescents. Providing precise and context-adapted intervention is the key to achieving intervention efficacy. Objective: This study aims to compare the effectiveness of three SSIs: single-session intervention of growth mindset on negative emotions (SIGMA), SSI of growth mindset of personality (SSI-GP), and active control, in reducing adolescent anxiety. Methods: Adolescents (N=549, ages 12-16 years) from secondary schools will be randomized to 1 of 3 intervention conditions: the SIGMA, SSI-GP, or active control. The implementation of each intervention is approximately 45 minutes in length. Adolescent participants will report anxiety symptoms (primary outcome), perceived control, hopelessness, attitude toward help-seeking, and psychological well-being at preintervention, the 2-week follow-up, and the 8-week follow-up. A pilot test has confirmed the feasibility and acceptability of SIGMA among adolescents. We hypothesized that SIGMA and SSI-GP will result in a larger reduction in anxiety symptoms than the control intervention during the posttest and 8-week follow-up period. We also predict that SIGMA will have a more significant effect than SSI-GP. We will use the intention-to-treat principle and linear regression-based maximum likelihood multilevel models for data analysis. Results: This study will be conducted from December 2022 to December 2023, with results expected to be available in January 2024. Conclusions: This protocol introduces the implementation content and strategies of growth mindset SSIs (consists of 2 forms: SIGMA and SSI-GP) among school students. The study will provide evidence on the efficacy of different growth mindset SSIs for adolescent anxiety. It will also establish implementation strategies for self-administrative SSIs among school students, which can serve as a pioneer implementation of a scalable and self-accessible brief intervention to improve the well-being of young people. Trial Registration: ClinicalTrials.gov NCT05027880; https://clinicaltrials.gov/ct2/show/NCT05027880 International Registered Report Identifier (IRRID): PRR1-10.2196/41758 %M 36930199 %R 10.2196/41758 %U https://www.researchprotocols.org/2023/1/e41758 %U https://doi.org/10.2196/41758 %U http://www.ncbi.nlm.nih.gov/pubmed/36930199 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e38429 %T The Impact of Social Media Interventions on Weight Reduction and Physical Activity Improvement Among Healthy Adults: Systematic Review %A Shiyab,Wa'ed %A Halcomb,Elizabeth %A Rolls,Kaye %A Ferguson,Caleb %+ School of Nursing, Faculty of Science, Medicine & Health University of Wollongong, Northfields Ave, Wollongong, 2522, Australia, 61 2 4221 3784, weys741@uowmail.edu.au %K social media %K physical activity %K overweight %K lifestyle risk factors %D 2023 %7 16.3.2023 %9 Review %J J Med Internet Res %G English %X Background: A sedentary lifestyle and being overweight or obese are well-established cardiovascular risk factors and contribute substantially to the global burden of disease. Changing such behavior is complex and requires support. Social media interventions show promise in supporting health behavior change, but their impact is unclear. Moreover, previous reviews have reported contradictory evidence regarding the relationship between engagement with social media interventions and the efficacy of these interventions. Objective: This review aimed to critically synthesize available evidence regarding the impact of social media interventions on physical activity and weight among healthy adults. In addition, this review examined the effect of engagement with social media interventions on their efficacy. Methods: CINAHL and MEDLINE were searched for relevant randomized trials that were conducted to investigate the impact of social media interventions on weight and physical activity and were published between 2011 and 2021 in the English language. Studies were included if the intervention used social media tools that provided explicit interactions between the participants. Studies were excluded if the intervention was passively delivered through an app website or if the participants had a known chronic disease. Eligible studies were appraised for quality and synthesized using narrative synthesis. Results: A total of 17 papers reporting 16 studies from 4 countries, with 7372 participants, were identified. Overall, 56% (9/16) of studies explored the effect of social media interventions on physical activity; 38% (6/16) of studies investigated weight reduction; and 6% (1/16) of studies assessed the effect on both physical activity and weight reduction. Evidence of the effects of social media interventions on physical activity and weight loss was mixed across the included studies. There were no standard metrics for measuring engagement with social media, and the relationship between participant engagement with the intervention and subsequent behavior change was also mixed. Although 35% (6/16) of studies reported that engagement was not a predictor of behavior change, engagement with social media interventions was found to be related to behavior change in 29% (5/16) of studies. Conclusions: Despite the promise of social media interventions, evidence regarding their effectiveness is mixed. Further robust studies are needed to elucidate the components of social media interventions that lead to successful behavior change. Furthermore, the effect of engagement with social media interventions on behavior change needs to be clearly understood. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42022311430; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=311430 %M 36927627 %R 10.2196/38429 %U https://www.jmir.org/2023/1/e38429 %U https://doi.org/10.2196/38429 %U http://www.ncbi.nlm.nih.gov/pubmed/36927627 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e44316 %T Engagement and Utilization of a Complete Remote Digital Care Program for Musculoskeletal Pain Management in Urban and Rural Areas Across the United States: Longitudinal Cohort Study %A Scheer,Justin %A Areias,Anabela C %A Molinos,Maria %A Janela,Dora %A Moulder,Robert %A Lains,Jorge %A Bento,Virgílio %A Yanamadala,Vijay %A Dias Correia,Fernando %A Costa,Fabíola %+ Sword Health Inc, 13937 Sprague Lane, Draper, UT, 84020, United States, 1 1 385 308 8034, f.costa@swordhealth.com %K physical therapy %K physiotherapy %K remote care %K telerehabilitation %K digital therapy %K eHealth %K telehealth %K telemedicine %K musculoskeletal %K musculoskeletal conditions %K urban %K rural %K pain %K health inequity %K digital care %K pain management %K clinical outcome %K health equity %K engagement %D 2023 %7 16.3.2023 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Musculoskeletal (MSK) conditions are the number one cause of disability worldwide. Digital care programs (DCPs) for MSK pain management have arisen as alternative care delivery models to circumvent challenges in accessibility of conventional therapy. Despite the potential of DCPs to reduce inequities in accessing care, the outcomes of such interventions in rural and urban populations have yet to be studied. Objective: The aim of this study was to assess the impact of urban or rural residency on engagement and clinical outcomes after a multimodal DCP for MSK pain. Methods: This study consists of an ad hoc analysis of a decentralized single-arm investigation into engagement and clinical-related outcomes after a multimodal DCP in patients with MSK conditions. Patients were coded according to their zip codes to a specific rural-urban commuting area code and grouped into rural and urban cohorts. Changes in their engagement and clinical outcomes from baseline to program end were assessed. Latent growth curve analysis was performed to estimate change trajectories adjusting for the following covariates: age, gender, BMI, employment status, and pain acuity. Outcomes included engagement, self-reported pain, and the results of the Generalized Anxiety Disorder 7-item, Patient Health Questionnaire 9-item, and Work Productivity and Activity Impairment scales. A minimum clinically important difference (MCID) of 30% was considered for pain. Results: Patients with urban and rural residency across the United States participated in the program (n=9992). A 73.8% (7378/9992) completion rate was observed. Both groups reported high satisfaction scores and similar engagement with exercise sessions, with rural residents showing higher engagement with educational content (P<.001) and higher program completion rates (P=.02). All groups showed a significant improvement in all clinical outcomes, including pain, mental health, and work productivity, without statistically significant intergroup differences. The percentage of patients meeting the MCID was similar in both groups (urban: 67.1%, rural: 68.3%; P=.30). Conclusions: This study advocates for the utility of a DCP in improving access to MSK care in urban and rural areas alike, showcasing its potential to promote health equity. High engagement, satisfaction, and completion rates were noted in both groups, as well as significant improvements in clinical outcomes. Trial Registration: ClinicalTrials.gov NCT04092946; https://clinicaltrials.gov/ct2/show/NCT04092946 %M 36735933 %R 10.2196/44316 %U https://mhealth.jmir.org/2023/1/e44316 %U https://doi.org/10.2196/44316 %U http://www.ncbi.nlm.nih.gov/pubmed/36735933 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e41275 %T The Relationship Between How Participants Articulate Their Goals and Accomplishments and Weight Loss Outcomes: Secondary Analysis of a Pilot of a Web-Based Weight Loss Intervention %A Jake-Schoffman,Danielle E %A Waring,Molly E %A DiVito,Joseph %A Goetz,Jared M %A Pan,Cindy %A Pagoto,Sherry L %+ Department of Health Education and Behavior, College of Health and Human Performance, University of Florida, PO Box 118210, Gainesville, FL, 32611, United States, 1 352 294 1046, djakeschoffman@ufl.edu %K weight loss %K social media %K goal setting %K web-based program %K behavior change %K habit formation %K diabetes %K Facebook %K lifestyle %D 2023 %7 16.3.2023 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: In behavioral weight loss interventions, participants are asked to set weekly goals to support long-term habits that lead to weight loss. Although participants are asked to set and accomplish weekly goals, we do not know how often they do this and whether doing so is associated with weight loss. Web-based weight loss interventions allow for the analysis of participant engagement data, including how participants articulate their goals and accomplishments. Objective: Using engagement data from a web-based weight loss intervention, we examined whether participants articulating their goals and accomplishments in measurable and repeating terms were associated with greater weight loss. Methods: Adults with overweight or obesity received a 12-week Facebook-delivered weight loss intervention based on the Diabetes Prevention Program Lifestyle Intervention. Participants replied to conversation threads that queried about their goals and accomplishments. Two independent coders classified participants’ posts that articulated goals or accomplishments as measurable or repeating. Crude and age-adjusted linear regression models were used to examine the relationship between the frequency of post type and percent weight loss. Results: Participants (N=53; n=48, 91% female; n=48, 91% non-Hispanic White) were on average 46.2 (SD 10.5) years old with a mean BMI of 32.4 (SD 4.8) kg/m2. Over 12 weeks, participants shared a median of 4 (IQR 1-8) posts that reported goals and 10 (IQR 4-24) posts that reported accomplishments. Most participants shared ≥1 post with a goal (n=43, 81%) and ≥1 post with an accomplishment (n=47, 89%). Each post reporting a goal was associated with 0.2% greater weight loss (95% CI −0.3% to 0.0%). Sharing ≥1 post with a repeating goal was associated with an average of 2.2% greater weight loss (95% CI −3.9% to −0.4%). Each post with a repeating goal was associated with an average of 0.5% greater weight loss (95% CI −1.0% to 0.0%). Sharing ≥1 post with measurable and repeating goals was associated with an average of 1.9% greater weight loss (95% CI −3.7% to −0.2%). Sharing each post with an accomplishment was associated with an average of 0.1% greater weight loss (95% CI −0.1% to 0.0%). Every post with an accomplishment that was repeating was associated with an average of 0.2% greater weight loss (95% CI −0.3% to 0.0%). Sharing other types of goals and accomplishments was not associated with weight loss. Conclusions: In a web-based weight loss intervention, stating goals in repeating or both measurable and repeating terms was associated with greater weight loss, but simply stating them in measurable terms was not. For accomplishments, only those articulated in repeating terms were associated with greater weight loss. Posts about one-time goals and accomplishments represent an opportunity to encourage planning for future behaviors. Future research should examine if stating goals and accomplishments in repeating terms signals habit formation. %M 36927569 %R 10.2196/41275 %U https://mhealth.jmir.org/2023/1/e41275 %U https://doi.org/10.2196/41275 %U http://www.ncbi.nlm.nih.gov/pubmed/36927569 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41413 %T Evaluation of Two Web-Based Interventions (Res-Up! and REMOTION) in Routine Outpatient Psychotherapy (Therapy Online Plus—TOP): Protocol for a Randomized Controlled Trial %A Trimpop,Leonie Franziska %A Bielinski,Laura Luisa %A Berger,Thomas %A Willutzki,Ulrike %+ Department of Clinical Psychology and Psychotherapy, University of Witten/Herdecke, Alfred-Herrhausen-Strasse 44, Witten, 58455, Germany, 49 2302 926 9704, leonie.trimpop@uni-wh.de %K online therapy %K randomized controlled trial %K transdiagnostic %K resilience %K emotion regulation %K capitalization %K compensation %K intervention %K psychotherapy %K Germany %K treatment %K mental disorder %K effectiveness %D 2023 %7 15.3.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Only 11%-40% of those with a mental disorder in Germany receive treatment. In many cases, face-to-face psychotherapy is not available because of limited resources, such as an insufficient number of therapists in the area. New approaches to improve the German health care system are needed to counter chronification. Web-based interventions have been shown to be effective as stand-alone and add-on treatments to routine practice. Interventions designed for a wide range of mental disorders such as transdiagnostic interventions are needed to make treatment for mental disorders more accessible and thus shorten waiting times and mitigate the chronification of mental health problems. In general, interventions can be differentiated as having either a capitalization (CAP) focus—thus drawing on already existing strengths—or a compensation (COMP) focus—trying to compensate for deficits. Up to now, the effectiveness of transdiagnostic web-based interventions with either a CAP or a COMP focus has not yet been evaluated. Objective: This study is the first to examine the effectiveness of two transdiagnostic web-based interventions: (1) the activation of resilience and drawing on existing strengths (CAP: Res-Up!) and (2) the improvement of emotion regulation (COMP: REMOTION), compared with care as usual (CAU) in routine outpatient psychotherapy. Methods: Adults with at least 1 mental health disorder will be recruited at 4 outpatient centers in Germany. Participants will then be randomized equally into 1 of the 2 intervention groups Res-Up! (CAP) and REMOTION (COMP) or into the control group (CAU). Assessments will be made at baseline (T0), at 6 weeks after treatment start (T1), and at 12 weeks after treatment start (T2). A primary outcome will be symptom severity (Brief Symptom Inventory-18). Secondary outcomes will focus on emotion regulation and resilience. Results: Participant recruitment and data collection started in April 2020 and were ongoing as of July 2022. We expect participants to benefit more from the interventions than from the CAU control on the dimensions of symptom severity, resilience, and emotion regulation. Furthermore, we expect to find possible differences between CAP and COMP. The results of the study are expected in 2023. Conclusions: This randomized controlled trial will compare CAU with the transdiagnostic web-based interventions Res-Up! and REMOTION, and will thus inform future studies concerning the effectiveness of transdiagnostic web-based interventions in routine outpatient psychotherapy. Trial Registration: ClinicalTrials.gov NCT04352010; https://clinicaltrials.gov/ct2/show/NCT04352010 International Registered Report Identifier (IRRID): DERR1-10.2196/41413 %M 36920449 %R 10.2196/41413 %U https://www.researchprotocols.org/2023/1/e41413 %U https://doi.org/10.2196/41413 %U http://www.ncbi.nlm.nih.gov/pubmed/36920449 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42134 %T Implementation Science Perspectives on Implementing Telemedicine Interventions for Hypertension or Diabetes Management: Scoping Review %A Khalid,Ayisha %A Dong,Quanfang %A Chuluunbaatar,Enkhzaya %A Haldane,Victoria %A Durrani,Hammad %A Wei,Xiaolin %+ Dalla Lana School of Public Health, University of Toronto, 155 College St., Toronto, ON, M5T 3M6, Canada, 1 416 978 2020, xiaolin.wei@utoronto.ca %K telemedicine %K hypertension %K diabetes %K implementation science %K mobile phone %D 2023 %7 14.3.2023 %9 Review %J J Med Internet Res %G English %X Background: Hypertension and diabetes are becoming increasingly prevalent worldwide. Telemedicine is an accessible and cost-effective means of supporting hypertension and diabetes management, especially as the COVID-19 pandemic has accelerated the adoption of technological solutions for care. However, to date, no review has examined the contextual factors that influence the implementation of telemedicine interventions for hypertension or diabetes worldwide. Objective: We adopted a comprehensive implementation research perspective to synthesize the barriers to and facilitators of implementing telemedicine interventions for the management of hypertension, diabetes, or both. Methods: We performed a scoping review involving searches in Ovid MEDLINE, Embase, CINAHL, Cochrane Library, Web of Science, and Google Scholar to identify studies published in English from 2017 to 2022 describing barriers and facilitators related to the implementation of telemedicine interventions for hypertension and diabetes management. The coding and synthesis of barriers and facilitators were guided by the Consolidated Framework for Implementation Research. Results: Of the 17,687 records identified, 35 (0.2%) studies were included in our scoping review. We found that facilitators of and barriers to implementation were dispersed across the constructs of the Consolidated Framework for Implementation Research. Barriers related to cost, patient needs and resources (eg, lack of consideration of language needs, culture, and rural residency), and personal attributes of patients (eg, demographics and priorities) were the most common. Facilitators related to the design and packaging of the intervention (eg, user-friendliness), patient needs and resources (eg, personalized information that leveraged existing strengths), implementation climate (eg, intervention embedded into existing infrastructure), knowledge of and beliefs about the intervention (eg, convenience of telemedicine), and other personal attributes (eg, technical literacy) were the most common. Conclusions: Our findings suggest that the successful implementation of telemedicine interventions for hypertension and diabetes requires comprehensive efforts at the planning, execution, engagement, and reflection and evaluation stages of intervention implementation to address challenges at the individual, interpersonal, organizational, and environmental levels. %M 36917174 %R 10.2196/42134 %U https://www.jmir.org/2023/1/e42134 %U https://doi.org/10.2196/42134 %U http://www.ncbi.nlm.nih.gov/pubmed/36917174 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e40259 %T The Effectiveness of Wearable Devices Using Artificial Intelligence for Blood Glucose Level Forecasting or Prediction: Systematic Review %A Ahmed,Arfan %A Aziz,Sarah %A Abd-alrazaq,Alaa %A Farooq,Faisal %A Househ,Mowafa %A Sheikh,Javaid %+ AI Center for Precision Health, Weill Cornell Medicine-Qatar, Education City, PO Box 24144, Doha, Qatar, 974 44928826, ara4013@qatar-med.cornell.edu %K diabetes %K artificial intelligence %K wearable devices %K machine learning %K blood glucose %K forecasting %K prediction %D 2023 %7 14.3.2023 %9 Review %J J Med Internet Res %G English %X Background: In 2021 alone, diabetes mellitus, a metabolic disorder primarily characterized by abnormally high blood glucose (BG) levels, affected 537 million people globally, and over 6 million deaths were reported. The use of noninvasive technologies, such as wearable devices (WDs), to regulate and monitor BG in people with diabetes is a relatively new concept and yet in its infancy. Noninvasive WDs coupled with machine learning (ML) techniques have the potential to understand and conclude meaningful information from the gathered data and provide clinically meaningful advanced analytics for the purpose of forecasting or prediction. Objective: The purpose of this study is to provide a systematic review complete with a quality assessment looking at diabetes effectiveness of using artificial intelligence (AI) in WDs for forecasting or predicting BG levels. Methods: We searched 7 of the most popular bibliographic databases. Two reviewers performed study selection and data extraction independently before cross-checking the extracted data. A narrative approach was used to synthesize the data. Quality assessment was performed using an adapted version of the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. Results: From the initial 3872 studies, the features from 12 studies were reported after filtering according to our predefined inclusion criteria. The reference standard in all studies overall (n=11, 92%) was classified as low, as all ground truths were easily replicable. Since the data input to AI technology was highly standardized and there was no effect of flow or time frame on the final output, both factors were categorized in a low-risk group (n=11, 92%). It was observed that classical ML approaches were deployed by half of the studies, the most popular being ensemble-boosted trees (random forest). The most common evaluation metric used was Clarke grid error (n=7, 58%), followed by root mean square error (n=5, 42%). The wide usage of photoplethysmogram and near-infrared sensors was observed on wrist-worn devices. Conclusions: This review has provided the most extensive work to date summarizing WDs that use ML for diabetic-related BG level forecasting or prediction. Although current studies are few, this study suggests that the general quality of the studies was considered high, as revealed by the QUADAS-2 assessment tool. Further validation is needed for commercially available devices, but we envisage that WDs in general have the potential to remove the need for invasive devices completely for glucose monitoring in the not-too-distant future. Trial Registration: PROSPERO CRD42022303175; https://tinyurl.com/3n9jaayc %M 36917147 %R 10.2196/40259 %U https://www.jmir.org/2023/1/e40259 %U https://doi.org/10.2196/40259 %U http://www.ncbi.nlm.nih.gov/pubmed/36917147 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e39250 %T eHealth-Based Psychosocial Interventions for Adults With Insomnia: Systematic Review and Meta-analysis of Randomized Controlled Trials %A Deng,Wenrui %A M J J van der Kleij,Rianne %A Shen,Hongxia %A Wei,Junjie %A Brakema,Evelyn A %A Guldemond,Nick %A Song,Xiaoyue %A Li,Xiaoming %A van Tol,Marie-José %A Aleman,André %A Chavannes,Niels H %+ Department of Public Health and Primary Care, Leiden University Medical Center, Albinusdreef 2, Leiden, 2300 RC, Netherlands, 31 644689783, w.deng@lumc.nl %K eHealth %K psychosocial interventions %K insomnia %K adults %K meta-analysis %K mobile phone %D 2023 %7 14.3.2023 %9 Review %J J Med Internet Res %G English %X Background: Worldwide, insomnia remains a highly prevalent public health problem. eHealth presents a novel opportunity to deliver effective, accessible, and affordable insomnia treatments on a population-wide scale. However, there is no quantitative integration of evidence regarding the effectiveness of eHealth-based psychosocial interventions on insomnia. Objective: We aimed to evaluate the effectiveness of eHealth-based psychosocial interventions for insomnia and investigate the influence of specific study characteristics and intervention features on these effects. Methods: We searched PubMed, Embase, Web of Science, PsycINFO, and the Cochrane Central Register of Controlled Trials from database inception to February 16, 2021, for publications investigating eHealth-based psychosocial interventions targeting insomnia and updated the search of PubMed to December 6, 2021. We also screened gray literature for unpublished data. Eligible studies were randomized controlled trials of eHealth-based psychosocial interventions targeting adults with insomnia. Random-effects meta-analysis models were used to assess primary and secondary outcomes. Primary outcomes were insomnia severity and sleep quality. Meta-analyses were performed by pooling the effects of eHealth-based psychosocial interventions on insomnia compared with inactive and in-person conditions. We performed subgroup analyses and metaregressions to explore specific factors that affected the effectiveness. Secondary outcomes included sleep diary parameters and mental health–related outcomes. Results: Of the 19,980 identified records, 37 randomized controlled trials (13,227 participants) were included. eHealth-based psychosocial interventions significantly reduced insomnia severity (Hedges g=−1.01, 95% CI −1.12 to −0.89; P<.001) and improved sleep quality (Hedges g=−0.58, 95% CI −0.75 to −0.41; P<.001) compared with inactive control conditions, with no evidence of publication bias. We found no significant difference compared with in-person treatment in alleviating insomnia severity (Hedges g=0.41, 95% CI −0.02 to 0.85; P=.06) and a significant advantage for in-person treatment in enhancing sleep quality (Hedges g=0.56, 95% CI 0.24-0.88; P<.001). eHealth-based psychosocial interventions had significantly larger effects (P=.01) on alleviating insomnia severity in clinical samples than in subclinical samples. eHealth-based psychosocial interventions that incorporated guidance from trained therapists had a significantly greater effect on insomnia severity (P=.05) and sleep quality (P=.02) than those with guidance from animated therapists or no guidance. Higher baseline insomnia severity and longer intervention duration were associated with a larger reduction in insomnia severity (P=.004). eHealth-based psychosocial interventions significantly improved each secondary outcome. Conclusions: eHealth interventions for insomnia are effective in improving sleep and mental health and can be considered a promising treatment for insomnia. Our findings support the wider dissemination of eHealth interventions and their further promotion in a stepped-care model. Offering blended care could improve treatment effectiveness. Future research needs to elucidate which specific intervention components are most important to achieve intervention effectiveness. Blended eHealth interventions may be tailored to benefit people with low socioeconomic status, limited access to health care, or lack of eHealth literacy. %M 36917145 %R 10.2196/39250 %U https://www.jmir.org/2023/1/e39250 %U https://doi.org/10.2196/39250 %U http://www.ncbi.nlm.nih.gov/pubmed/36917145 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e39977 %T Development of a ParticipACTION App–Based Intervention for Improving Postsecondary Students’ 24-Hour Movement Guideline Behaviors: Protocol for the Application of Intervention Mapping %A Flood,Stephanie M %A Thompson,Brooke %A Faulkner,Guy %A Vanderloo,Leigh M %A Blackett,Beth %A Dolf,Matt %A Latimer-Cheung,Amy E %A Duggan,Mary %A Di Sebastiano,Katie M %A Lane,Kirstin N %A Brouwers,Melissa C %A McKenna,Julia %A Chulak-Bozzer,Tala %A Fuller,Daniel %A Ruissen,Geralyn R %A Sturrock,Shelby L %A Tomasone,Jennifer R %+ School of Kinesiology and Health Studies, Queen's University, Room 301F, 28 Division Street, Kingston, ON, K7L 3N6, Canada, 1 6135336000 ext 79193, tomasone@queensu.ca %K 24-Hour Movement Guidelines %K multiple behavior change %K mobile health %K mHealth %K postsecondary students %K physical activity %K sedentary behavior %K sleep %K app %K mobile phone %D 2023 %7 14.3.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: The Canadian 24-Hour Movement Guidelines for adults provide specific recommendations for levels of physical activity, sedentary behavior, and sleep (ie, the movement behaviors) required for optimal health. Performance of the movement behaviors is associated with improved mental well-being. However, most postsecondary students do not meet the movement behavior recommendations within the Canadian 24-Hour Movement Guidelines and experience increased stress and declining well-being, suggesting the need for an intervention targeting students’ movement behaviors. Objective: We aimed to develop and implement a theory-informed intervention intended to improve the movement behaviors and mental well-being of first-year postsecondary students. Methods: The Intervention Mapping protocol was applied in the development and implementation of the intervention. Intervention Mapping entailed performing a needs assessment, determining the intervention outcomes, selecting theory- and evidence-based change methods and applications, preparing and producing intervention plans and materials, developing the implementation plan, and finally developing an evaluation plan. The Theoretical Domains Framework and the Behavior Change Wheel were also used in conjunction with the Intervention Mapping protocol to ensure a solid theoretical basis for the intervention. This protocol led to the development and implementation of a 6-week, theory-informed ParticipACTION app–based intervention aimed at helping first-year postsecondary students improve their movement behaviors and mental well-being. The developed app content provided students with information on each of the movement behaviors and behavioral strategies (ie, goal setting, action planning, monitoring, and coping planning). The use of Intervention Mapping allowed for the continuous involvement of various multidisciplinary partners and end users, ensuring that the intervention design and implementation was appropriate for the target audience. The feasibility, acceptability, and potential impact of the intervention will be examined in a subsequent proof-of-concept study at 2 Canadian university campuses. Results: Participant recruitment occurred during September 2021, and the intervention was conducted from October to December 2021. The deadline for completion of the postintervention questionnaire by participants was mid-December 2021. The analysis of data examining the feasibility, acceptability, and potential impact of the intervention began in January 2022, with the publication of the proof-of-concept evaluation expected in 2023. Conclusions: Intervention Mapping with the Theoretical Domains Framework and Behavior Change Wheel was a useful approach to combine evidence and theoretical concepts to guide the design and implementation of a ParticipACTION app–based intervention targeting postsecondary students’ movement behaviors and mental well-being. This process may serve as an example for other researchers developing multiple behavior change app–based interventions. Should the forthcoming evaluation demonstrate the intervention’s acceptability, feasibility, and potential impact, the intervention may provide a scalable method of improving postsecondary students’ movement behaviors and mental well-being. International Registered Report Identifier (IRRID): RR1-10.2196/39977 %M 36917173 %R 10.2196/39977 %U https://www.researchprotocols.org/2023/1/e39977 %U https://doi.org/10.2196/39977 %U http://www.ncbi.nlm.nih.gov/pubmed/36917173 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45218 %T Diagnostic Ability of a Smartphone App for Dry Eye Disease: Protocol for a Multicenter, Open-Label, Prospective, and Cross-sectional Study %A Nagino,Ken %A Okumura,Yuichi %A Yamaguchi,Masahiro %A Sung,Jaemyoung %A Nagao,Masashi %A Fujio,Kenta %A Akasaki,Yasutsugu %A Huang,Tianxiang %A Hirosawa,Kunihiko %A Iwagami,Masao %A Midorikawa-Inomata,Akie %A Fujimoto,Keiichi %A Eguchi,Atsuko %A Okajima,Yukinobu %A Kakisu,Koji %A Tei,Yuto %A Yamaguchi,Takefumi %A Tomida,Daisuke %A Fukui,Masaki %A Yagi-Yaguchi,Yukari %A Hori,Yuichi %A Shimazaki,Jun %A Nojiri,Shuko %A Morooka,Yuki %A Yee,Alan %A Miura,Maria %A Ohno,Mizu %A Inomata,Takenori %+ Department of Ophthalmology, Juntendo University Graduate School of Medicine, 3-1-3 Hongo, Bunkyo-ku, Tokyo, 1130033, Japan, 81 358021228, tinoma@juntendo.ac.jp %K digital health %K digital therapeutics %K dry eye disease %K Japanese version of the Ocular Surface Disease Index %K maximum blink interval %K mobile health %K smartphone %K smartphone app %K tear film breakup time %K telemedicine %D 2023 %7 13.3.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Dry eye disease (DED) is one of the most common ocular surface diseases. Numerous patients with DED remain undiagnosed and inadequately treated, experiencing various subjective symptoms and a decrease in quality of life and work productivity. A mobile health smartphone app, namely, the DEA01, has been developed as a noninvasive, noncontact, and remote screening device, in the context of an ongoing paradigm shift in the health care system, to facilitate a diagnosis of DED. Objective: This study aimed to evaluate the capabilities of the DEA01 smartphone app to facilitate a DED diagnosis. Methods: In this multicenter, open-label, prospective, and cross-sectional study, the test method will involve using the DEA01 smartphone app to collect and evaluate DED symptoms, based on the Japanese version of the Ocular Surface Disease Index (J-OSDI), and to measure the maximum blink interval (MBI). The standard method will then involve a paper-based J-OSDI evaluation of subjective symptoms of DED and tear film breakup time (TFBUT) measurement in an in-person encounter. We will allocate 220 patients to DED and non-DED groups, based on the standard method. The primary outcome will be the sensitivity and specificity of the DED diagnosis according to the test method. Secondary outcomes will be the validity and reliability of the test method. The concordance rate, positive and negative predictive values, and the likelihood ratio between the test and standard methods will be assessed. The area under the curve of the test method will be evaluated using a receiver operating characteristic curve. The internal consistency of the app-based J-OSDI and the correlation between the app-based J-OSDI and paper-based J-OSDI will be assessed. A DED diagnosis cutoff value for the app-based MBI will be determined using a receiver operating characteristic curve. The app-based MBI will be assessed to determine a correlation between a slit lamp–based MBI and TFBUT. Adverse events and DEA01 failure data will be collected. Operability and usability will be assessed using a 5-point Likert scale questionnaire. Results: Patient enrollment will start in February 2023 and end in July 2023. The findings will be analyzed in August 2023, and the results will be reported from March 2024 onward. Conclusions: This study may have implications in identifying a noninvasive, noncontact route to facilitate a diagnosis of DED. The DEA01 may enable a comprehensive diagnostic evaluation within a telemedicine setting and facilitate early intervention for undiagnosed patients with DED confronting health care access barriers. Trial Registration: Japan Registry of Clinical Trials jRCTs032220524; https://jrct.niph.go.jp/latest-detail/jRCTs032220524 International Registered Report Identifier (IRRID): PRR1-10.2196/45218 %M 36912872 %R 10.2196/45218 %U https://www.researchprotocols.org/2023/1/e45218 %U https://doi.org/10.2196/45218 %U http://www.ncbi.nlm.nih.gov/pubmed/36912872 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e37351 %T Text Messages Exchanged Between Individuals With Opioid Use Disorder and Their mHealth e-Coaches: Content Analysis Study %A Ranjit,Yerina S %A Davis,Warren M %A Fentem,Andrea %A Riordan,Raven %A Roscoe,Rikki %A Cavazos-Rehg,Patricia %+ Department of Communication, University of Missouri, 207 Switzler Hall, Columbia, MO, 65211, United States, 1 573 882 4431, ranjity@missouri.edu %K opioid use disorder %K opioid %K opium %K overdose %K drug %K substance use %K content analysis %K text message intervention %K text message %K text messaging %K mobile health %K mHealth %K social support %K e-coach %K counseling %K mental health %K depression %K recovery support %K eHealth %K digital health %D 2023 %7 10.3.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Opioid use disorder (OUD) has affected 2.2 million people in the United States. About 7.2 million people reported using illicit drugs in 2019, which contributed to over 70,000 overdose deaths. SMS text messaging interventions have been shown to be effective in OUD recovery. However, the interpersonal communication between individuals in OUD treatment and a support team on digital platforms has not been well examined. Objective: This study aims to understand the communication between participants undergoing OUD recovery and their e-coaches by examining the SMS text messages exchanged from the lens of social support and the issues related to OUD treatment. Methods: A content analysis of messages exchanged between individuals recovering from OUD and members of a support team was conducted. Participants were enrolled in a mobile health intervention titled “uMAT-R,” a primary feature of which is the ability for patients to instantly connect with a recovery support staff or an “e-coach” via in-app messaging. Our team analyzed dyadic text-based messages of over 12 months. In total, 70 participants’ messages and 1196 unique messages were analyzed using a social support framework and OUD recovery topics. Results: Out of 70 participants, 44 (63%) were between the ages of 31 and 50 years, 47 (67%) were female, 41 (59%) were Caucasian, and 42 (60%) reported living in unstable housing conditions. An average of 17 (SD 16.05) messages were exchanged between each participant and their e-coach. Out of 1196 messages, 64% (n=766) messages were sent by e-coaches and 36% (n=430) by participants. Messages of emotional support occurred the most, with 196 occurrences (n=9, 0.8%) and e-coaches (n=187, 15.6%). Messages of material support had 110 occurrences (participants: n=8, 0.7%; e-coaches: n=102, 8.5%). With OUD recovery topics, opioid use risk factors appeared in most (n=72) occurrences (patient: n=66, 5.5%; e-coach: n=6, 0.5%), followed by a message of avoidance of drug use 3.9% (n=47), which occurred mainly from participants. Depression was correlated with messages of social support (r=0.27; P=.02). Conclusions: Individuals with OUD who had mobile health needs tended to engage in instant messaging with the recovery support staff. Participants who are engaged in messaging often engage in conversations around risk factors and avoidance of drug use. Instant messaging services can be instrumental in providing the social and educational support needs of individuals recovering from OUD. %M 36897632 %R 10.2196/37351 %U https://humanfactors.jmir.org/2023/1/e37351 %U https://doi.org/10.2196/37351 %U http://www.ncbi.nlm.nih.gov/pubmed/36897632 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44254 %T Implementing an Activity Tracker to Increase Motivation for Physical Activity in Patients With Diabetes in Primary Care: Strengths, Weaknesses, Opportunities and Threats (SWOT) Analysis %A Pelletier,Cynthia %A Chabot,Christian %A Gagnon,Marie-Pierre %A Rhéaume,Caroline %+ Department of Family Medicine and Emergency Medicine, Faculty of Medicine, Université Laval, Local 4617, 1050 avenue de la Médecine, Pavillon Ferdinand-Vandry, Québec, QC, G1V 0A6, Canada, 1 418 656 8711 ext 5172, caroline.rheaume@fmed.ulaval.ca %K activity tracker %K type 2 diabetes %K family medicine research %K SWOT analysis %K physical activity %K physical activity motivation %K diabetes %K implementation %K chronic disease %K intervention %K questionnaire %K tool %D 2023 %7 10.3.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Many projects related to technology implementation in the context of chronic diseases have been developed over the years to better manage lifestyle medicine interventions and improve patient care. However, technology implementation in primary care settings remains challenging. Objective: The aim is to carry out a strengths, weaknesses, opportunities, and threats (SWOT) analysis (1) to assess satisfaction among patients with type 2 diabetes using an activity tracker to increase motivation for physical activity (PA) and (2) to explore the research and health care team’s perceptions of this technology’s implementation in a primary care setting. Methods: A 3-month hybrid type 1 study, which included 2 stages, was conducted in an academic primary health center in Quebec City, Quebec, Canada. In stage 1, a total of 30 patients with type 2 diabetes were randomized to the intervention (activity tracker) group or the control group. In stage 2, a SWOT analysis was performed on both patients and health care professionals to determine the components of successful technology implementation. Two questionnaires were used to gather feedback: a satisfaction and acceptability questionnaire concerning an activity tracker (15 patients in the intervention group) and a questionnaire based on the SWOT elements (15 patients in the intervention group and 7 health care professionals). Both questionnaires contained quantitative and qualitative questions. Qualitative variables from open questions were synthesized in a matrix and ranked according to apparition frequency and global importance. A thematic analysis was performed by the first author and validated by 2 coauthors separately. The information gathered was triangulated to propose recommendations that were then approved by the team. Both quantitative (randomized controlled trial participants) and qualitative (randomized controlled trial participants and team) results were combined for recommendations. Results: In total, 86% (12/14) of the participants were satisfied with their activity tracker use and 75% (9/12) felt that it incited them to stick to their PA program. The main strengths of the team members’ perspectives were the project initiation and involvement of a patient partner, the study design, the team, and the device. The weaknesses were the budgetary constraints, the turnover, and the technical issues. The opportunities were the primary care setting, the loan of equipment, and common technology. The threats were recruitment issues, administrative challenges, technological difficulties, and a single research site. Conclusions: Patients with type 2 diabetes were satisfied with their activity tracker used to improve motivation for PA. Health care team members agreed that implementation can be done in primary care, but some challenges remain in using this technological tool in clinical practice regularly. Trial Registration: ClinicalTrials.gov NCT03709966; https://clinicaltrials.gov/ct2/show/NCT03709966 %M 36897642 %R 10.2196/44254 %U https://formative.jmir.org/2023/1/e44254 %U https://doi.org/10.2196/44254 %U http://www.ncbi.nlm.nih.gov/pubmed/36897642 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e39993 %T The Effects of Exergaming on Executive and Physical Functions in Older Adults With Dementia: Randomized Controlled Trial %A Wu,Shanshan %A Ji,Hongqing %A Won,Junyeon %A Jo,Eun-Ah %A Kim,Yun-Sik %A Park,Jung-Jun %+ Division of Sport Science, Pusan National University, 509 Kyongam Gymnasium, Busandaehak-ro 63 beon-gil 2, Geumjeong-gu, Busan, 46241, Republic of Korea, 82 051 510 2713, jjparkpnu@pusan.ac.kr %K exergame %K exergaming %K executive function %K physical function %K reaction time %K N2 %K P3b %K physical %K function %K game %K dementia %K RCT %K cognitive function %K older adults %K aerobic exercise %K exercise %K neuronal %K activity %K task %K stimulation %K intervention %D 2023 %7 7.3.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite increasing interest in the effects of exergaming on cognitive function, little is known about its effects on older adults with dementia. Objective: The purpose of this is to investigate the effects of exergaming on executive and physical functions in older adults with dementia compared to regular aerobic exercise. Methods: In total, 24 older adults with moderate dementia participated in the study. Participants were randomized into either the exergame group (EXG, n=13, 54%) or the aerobic exercise group (AEG, n=11, 46%). For 12 weeks, EXG engaged in a running-based exergame and AEG performed a cycling exercise. At baseline and postintervention, participants underwent the Ericksen flanker test (accuracy % and response time [RT]) while recording event-related potentials (ERPs) that included the N2 and P3b potentials. Participants also underwent the senior fitness test (SFT) and the body composition test pre- and postintervention. Repeated-measures ANOVA was performed to assess the effects of time (pre- vs postintervention), group (EXG vs AEG), and group×time interactions. Results: Compared to AEG, EXG demonstrated greater improvements in the SFT (F1.22=7.434, P=.01), reduction in body fat (F1.22=6.476, P=.02), and increase in skeletal mass (F1.22=4.525, P=.05), fat-free mass (F1.22=6.103, P=.02), and muscle mass (F1.22=6.636, P=.02). Although there was a significantly shorter RT in EXG postintervention (congruent P=.03, 95% CI 13.581-260.419, incongruent P=.04, 95% CI 14.621-408.917), no changes occurred in AEG. EXG also yielded a shorter N2 latency for central (Cz) cortices during both congruent conditions compared to AEG (F1.22=4.281, P=.05). Lastly, EXG presented a significantly increased P3b amplitude compared to AEG during the Ericksen flanker test (congruent: frontal [Fz] F1.22=6.546, P=.02; Cz F1.22=5.963, P=.23; parietal [Pz] F1.22=4.302, P=.05; incongruent: Fz F1.22=8.302, P=.01; Cz F1.22=15.199, P=.001; Pz F1.22=13.774, P=.001). Conclusions: Our results suggest that exergaming may be associated with greater improvements in brain neuronal activity and enhanced executive function task performance than regular aerobic exercise. Exergaming characterized by both aerobic exercise and cognitive stimulation can be used as an effective intervention to improve cognitive and physical functions in older adults with dementia. Trial Registration: Clinical Research Information Service KCT0008238; https://cris.nih.go.kr/cris/search/detailSearch.do/24170 %M 36881445 %R 10.2196/39993 %U https://www.jmir.org/2023/1/e39993 %U https://doi.org/10.2196/39993 %U http://www.ncbi.nlm.nih.gov/pubmed/36881445 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e42399 %T Mediating Role of Treatment Perceptions in the Relationship Between Individual Characteristics and Engagement With a Digital Psychological Intervention for Pediatric Chronic Pain: Secondary Data Analysis %A de la Vega,Rocio %A Palermo,Tonya M %+ Center for Child Health, Behavior and Development, Seattle Children’s Research Institute, M/S CURE-3, PO Box 5371, Seattle, WA, 98145-5005, United States, 1 206 884 4208, tonya.palermo@seattlechildrens.org %K treatment adherence %K treatment perceptions %K mediators %K pediatric pain %K psychological intervention %K digital health %K treatment %K intervention %K engagement %K self-management %K psychological %D 2023 %7 6.3.2023 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Engagement predicts benefits from self-managed treatments. However, engagement is an important concern in digital interventions, with over 50% of patients being nonadherent to interventions in chronic conditions such as chronic pain. Little is known about the individual characteristics that contribute to engagement with a digital self-management treatment. Objective: This study tested the mediating role of treatment perceptions (difficulty and helpfulness) in the association between individual baseline characteristics (treatment expectancies and readiness to change) and treatment engagement (online and offline) with a digital psychological intervention for adolescents with chronic pain. Methods: A secondary data analysis of a single-arm trial of Web-based Management of Adolescent Pain, a self-guided internet intervention developed for the management of chronic pain in adolescents, was conducted. Survey data were collected at baseline (T1), midtreatment (ie, 4 weeks after the treatment started; T2), and post treatment (T3). Online engagement was assessed using back-end information on the number of days adolescents accessed the treatment website, while the offline engagement was assessed with the reported frequency of use of skills (ie, pain management strategies) learned at the end of the treatment. Four parallel multiple mediator linear regression models, using ordinary least square regression incorporating the variables were tested. Results: In total, 85 adolescents with chronic pain (12-17 years old, 77% female) participated. Several mediation models were significant in predicting online engagement. A significant indirect effect was found for the path expectancies–helpfulness–online engagement (effect 0.125; SE 0.098; 95% CI 0.013-0.389) and for the path precontemplation–helpfulness–online engagement (effect −1.027; SE 0.650; 95% CI −2.518 to −0.054). Fourteen percent of the variance of online engagement was explained by the model including expectancies as a predictor (F3=3.521; P<.05), whereas 15% was explained by the model where readiness to change was the predictor (F3=3.934; P<.05). Offline engagement was partially explained in the model including readiness to change as the predictor but with marginal significance (F3=2.719; R2=0.111; P=.05). Conclusions: Treatment perception, specifically, perceived helpfulness, was a mediator of the pathway between both treatment expectancies and readiness to change and online engagement with a digital psychological intervention for chronic pain. Assessing these variables at baseline and midtreatment may help to determine the risk of nonadherence. Further work is needed to confirm these mediation pathways in larger samples. Trial Registration: ClinicalTrials.gov NCT04043962; https://clinicaltrials.gov/ct2/show/NCT04043962 %M 36877543 %R 10.2196/42399 %U https://pediatrics.jmir.org/2023/1/e42399 %U https://doi.org/10.2196/42399 %U http://www.ncbi.nlm.nih.gov/pubmed/36877543 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e40104 %T The Use of Evaluation Panels During the Development of a Digital Intervention for Veterans Based on Cognitive Behavioral Therapy for Insomnia: Qualitative Evaluation Study %A Ryan,Arthur Thomas %A Brenner,Lisa Anne %A Ulmer,Christi S %A Mackintosh,Margaret-Anne %A Greene,Carolyn J %+ Rocky Mountain Mental Illness Research, Education and Clinical Center for Suicide Prevention, Department of Veterans Affairs, Rocky Mountain Regional Veterans Affairs Medical Center, 1700 N Wheeling St, G-3-116M, Aurora, CO, 80045, United States, 1 720 723 7493, arthur.ryan@va.gov %K cognitive behavioral therapy for insomnia %K CBT-I %K insomnia %K digital mental health intervention %K digital MH intervention %K internet-delivered %K veterans %K Path to Better Sleep %D 2023 %7 6.3.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Individuals enrolling in the Veterans Health Administration frequently report symptoms consistent with insomnia disorder. Cognitive behavioral therapy for insomnia (CBT-I) is a gold standard treatment for insomnia disorder. While the Veterans Health Administration has successfully implemented a large dissemination effort to train providers in CBT-I, the limited number of trained CBT-I providers continues to restrict the number of individuals who can receive CBT-I. Digital mental health intervention adaptations of CBT-I have been found to have similar efficacy as traditional CBT-I. To help address the unmet need for insomnia disorder treatment, the VA commissioned the creation of a freely available, internet-delivered digital mental health intervention adaptation of CBT-I known as Path to Better Sleep (PTBS). Objective: We aimed to describe the use of evaluation panels composed of veterans and spouses of veterans during the development of PTBS. Specifically, we report on the methods used to conduct the panels, the feedback they provided on elements of the course relevant to user engagement, and how their feedback influenced the design and content of PTBS. Methods: A communications firm was contracted to recruit 3 veteran (n=27) and 2 spouse of veteran (n=18) panels and convene them for three 1-hour meetings. Members of the VA team identified key questions for the panels, and the communications firm prepared facilitator guides to elicit feedback on these key questions. The guides provided a script for facilitators to follow while convening the panels. The panels were telephonically conducted, with visual content displayed via remote presentation software. The communications firm prepared reports summarizing the panelists’ feedback during each panel meeting. The qualitative feedback described in these reports served as the raw material for this study. Results: The panel members provided markedly consistent feedback on several elements of PTBS, including recommendations to emphasize the efficacy of CBT-I techniques; clarify and simplify written content as much as possible; and ensure that content is consistent with the lived experiences of veterans. Their feedback was congruent with previous studies on the factors influencing user engagement with digital mental health interventions. Panelist feedback influenced multiple course design decisions, including reducing the effort required to use the course’s sleep diary function, making written content more concise, and selecting veteran testimonial videos that emphasized the benefits of treating chronic insomnia symptoms. Conclusions: The veteran and spouse evaluation panels provided useful feedback during the design of PTBS. This feedback was used to make concrete revisions and design decisions consistent with existing research on improving user engagement with digital mental health interventions. We believe that many of the key feedback messages provided by these evaluation panels could prove useful to other digital mental health intervention designers. %M 36877553 %R 10.2196/40104 %U https://formative.jmir.org/2023/1/e40104 %U https://doi.org/10.2196/40104 %U http://www.ncbi.nlm.nih.gov/pubmed/36877553 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e44940 %T A Relational Agent Intervention for Adolescents Seeking Mental Health Treatment: Protocol for a Randomized Controlled Trial %A Chiauzzi,Emil %A Robinson,Athena %A Martin,Kate %A Petersen,Carl %A Wells,Nicole %A Williams,Andre %A Gleason,Mary Margaret %+ Woebot Health, 535 Mission Street, 14th Floor, San Francisco, CA, 94105, United States, 1 6502242216, athena@woebothealth.com %K adolescent %K digital health %K cognitive behavioral therapy %K CBT %K chatbot %K feasibility %K therapeutic alliance %K depression %K anxiety %K relational agent %K mental health care %K intervention %K agent %K youth %K teenager %K mental health %K treatment %K protocol %K feasibility %K randomized controlled trial %K acceptability %K telehealth %K outcome %K utility %D 2023 %7 3.3.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Unmet pediatric mental health (MH) needs are growing as rates of pediatric depression and anxiety dramatically increase. Access to care is limited by multiple factors, including a shortage of clinicians trained in developmentally specific, evidence-based services. Novel approaches to MH care delivery, including technology-leveraged and readily accessible options, need to be evaluated in service of expanding evidence-based services to youths and their families. Preliminary evidence supports the use of Woebot, a relational agent that digitally delivers guided cognitive behavioral therapy (CBT) through a mobile app, for adults with MH concerns. However, no studies have evaluated the feasibility and acceptability of such app-delivered relational agents specifically for adolescents with depression and/or anxiety within an outpatient MH clinic, nor compared them to other MH support services. Objective: This paper describes the protocol for a randomized controlled trial evaluating the feasibility and acceptability of an investigational device, Woebot for Adolescents (W-GenZD), within an outpatient MH clinic for youths presenting with depression and/or anxiety. The study’s secondary aim will compare the clinical outcomes of self-reported depressive symptoms with W-GenZD and a telehealth-delivered CBT-based skills group (CBT-group). Tertiary aims will evaluate additional clinical outcomes and therapeutic alliance between adolescents in W-GenZD and the CBT-group. Methods: Participants include youths aged 13-17 years with depression and/or anxiety seeking care from an outpatient MH clinic at a children’s hospital. Eligible youths will have no recent safety concerns or complex comorbid clinical diagnoses; have no concurrent individual therapy; and, if on medications, are on stable doses, based on clinical screening and as well as study-specific criteria. Results: Recruitment began in May 2022. As of December 8, 2022, we have randomized 133 participants. Conclusions: Establishing the feasibility and acceptability of W-GenZD within an outpatient MH clinical setting will add to the field’s current understanding of the utility and implementation considerations of this MH care service modality. The study will also evaluate the noninferiority of W-GenZD against the CBT-group. Findings may also have implications for patients, families, and providers looking for additional MH support options for adolescents seeking help for their depression and/or anxiety. Such options expand the menu of supports for youths with lower-intensity needs as well as possibly reduce waitlists and optimize clinician deployment toward more severe cases. Trial Registration: ClinicalTrials.gov NCT05372913; https://clinicaltrials.gov/ct2/show/NCT05372913 International Registered Report Identifier (IRRID): DERR1-10.2196/44940 %M 36867455 %R 10.2196/44940 %U https://www.researchprotocols.org/2023/1/e44940 %U https://doi.org/10.2196/44940 %U http://www.ncbi.nlm.nih.gov/pubmed/36867455 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e38632 %T The Design, Development, and Implementation of a Web-Enabled Informatics Platform to Enhance the Well-being of Individuals Aged 18-24 Years: Protocol for an Experimental Study %A Malhotra,Bhavya %A Sahoo,Jagannath %A Gupta,Mansi %A Joshi,Ashish %+ Dehradun Institute of Technology University, Mussoorie-Diversion Road, Village Makkawala, Dehradun, 248009, India, 91 7838632102, malhotra.bhavya01@gmail.com %K well-being %K mental health %K nutrition %K youth %K digital health %K interventions %K India %K health %K lifestyle %D 2023 %7 3.3.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Well-being is multidimensional, complex, and dynamic in nature. It is an amalgam of physical and mental health, essential for disease prevention and the promotion of a healthy life. Objective: This study aims to explore the features that impact the well-being of individuals between 18 and 24 years of age in an Indian setting. It further aims to design, develop, and evaluate the usefulness and effectiveness of a web-based informatics platform or stand-alone intervention to enhance the well-being of individuals aged 18-24 years in an Indian setting. Methods: This study follows a mixed method approach to identify factors influencing the well-being of individuals in the age group of 18-24 years in an Indian setting. The college-going students in this age group from the states of Uttarakhand (urban settings of Dehradun) and Uttar Pradesh (urban settings of Meerut) will be enrolled. They will be randomly allocated to the control and intervention groups. The participants in the intervention group will have access to the web-based well-being platform. Results: This study will examine the factors that influence the well-being of individuals aged 18-24 years. It will also facilitate the design and development of the web-based platform or stand-alone intervention, which will enhance the well-being of individuals in the age group of 18-24 years in an Indian setting. Furthermore, the results of this study will help generate a well-being index for individuals to plan tailored interventions. The 60 in-depth interviews have been conducted as of September 30, 2022. Conclusions: The study will help understand the factors that influence the well-being of individuals. The findings of this study will help in the design and development of the web-based platform or stand-alone intervention to enhance the well-being of individuals in the age group of 18-24 years in an Indian setting. International Registered Report Identifier (IRRID): PRR1-10.2196/38632 %M 36867449 %R 10.2196/38632 %U https://www.researchprotocols.org/2023/1/e38632 %U https://doi.org/10.2196/38632 %U http://www.ncbi.nlm.nih.gov/pubmed/36867449 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e38758 %T Promoting Self-management and Patient Activation Through eHealth: Protocol for a Systematic Literature Review and Meta-analysis %A Moradian,Saeed %A Maguire,Roma %A Liu,Geoffrey %A Krzyzanowska,Monika K %A Butler,Marcus %A Cheung,Chantal %A Signorile,Marisa %A Gregorio,Nancy %A Ghasemi,Shiva %A Howell,Doris %+ University of Strathclyde, Office 13.15 Livingston Tower, 26 Richmond Street, Glasgow, G1 1XQ, United Kingdom, 44 548 3589, roma.maguire@strath.ac.uk %K digital health %K cancer supportive care %K cancer-related symptoms %K self-efficacy %K supported self-management %D 2023 %7 2.3.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Major advances in different cancer treatment modalities have been made, and people are now living longer with cancer. However, patients with cancer experience a range of physical and psychological symptoms during and beyond cancer treatment. New models of care are needed to combat this rising challenge. A growing body of evidence supports the effectiveness of eHealth interventions in the delivery of supportive care to people living with the complexities of chronic health conditions. However, reviews on the effects of eHealth interventions are scarce in the field of cancer-supportive care, particularly for interventions with the aim of empowering patients to manage cancer treatment–related symptoms. For this reason, this protocol has been developed to guide a systematic review and meta-analysis to assess the effectiveness of eHealth interventions for supporting patients with cancer in managing cancer-related symptoms. Objective: This systematic review with meta-analysis is conducted with the aim of identifying eHealth-based self-management intervention studies for adult patients with cancer and evaluating the efficacy of eHealth-based self-management tools and platforms in order to synthesize the empirical evidence on self-management and patient activation through eHealth. Methods: A systematic review with meta-analysis and methodological critique of randomized controlled trials is conducted following Cochrane Collaboration methods. Multiple data sources are used to identify all potential research sources for inclusion in the systematic review: (1) electronic databases such as MEDLINE, (2) forward reference searching, and (3) gray literature. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for conducting the review were followed. The PICOS (Population, Interventions, Comparators, Outcomes, and Study Design) framework is used to identify relevant studies. Results: The literature search yielded 10,202 publications. The title and abstract screening were completed in May 2022. Data will be summarized, and if possible, meta-analyses will be performed. It is expected to finalize this review by Winter 2023. Conclusions: The results of this systematic review will provide the latest data on leveraging eHealth interventions and offering effective and sustainable eHealth care, both of which have the potential to improve quality and efficiency in cancer-related symptoms. Trial Registration: PROSPERO 325582; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=325582 International Registered Report Identifier (IRRID): DERR1-10.2196/38758 %M 36862481 %R 10.2196/38758 %U https://www.researchprotocols.org/2023/1/e38758 %U https://doi.org/10.2196/38758 %U http://www.ncbi.nlm.nih.gov/pubmed/36862481 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e40961 %T Influences on Patient Uptake of and Engagement With the National Health Service Digital Diabetes Prevention Programme: Qualitative Interview Study %A Ross,Jamie %A Cotterill,Sarah %A Bower,Peter %A Murray,Elizabeth %+ Centre for Primary Care, Wolfson Institute of Population Health Science, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, United Kingdom, 44 20 8016 80, Jamie.ross@qmul.ac.uk %K diabetes prevention %K digital health interventions %K engagement %K qualitative research %K mobile phone %D 2023 %7 28.2.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital diabetes prevention programs (digital-DPPs) are being implemented as population-based approaches to type 2 diabetes mellitus prevention in several countries to address problems with the uptake of traditional face-to-face diabetes prevention programs. However, assessments of digital-DPPs have largely focused on clinical outcomes and usability among those who have taken them up, whereas crucial information on decision-making about uptake (eg, whether a user downloads and registers on an app) and engagement (eg, the extent of use of an app or its components over time) is limited. Greater understanding of factors that influence uptake and engagement decisions may support large-scale deployments of digital-DPPs in real-world settings. Objective: This study aimed to explore the key influences on uptake and engagement decisions of individuals who were offered the National Health Service Healthier You: Digital Diabetes Prevention Programme (NHS-digital-DPP). Methods: A qualitative interview study was conducted using semistructured interviews. Participants were adults, aged ≥18 years, diagnosed with nondiabetic hyperglycemia, and those who had been offered the NHS-digital-DPP. Recruitment was conducted via 4 providers of the NHS-digital-DPP and 3 primary care practices in England. Interviews were conducted remotely and were guided by a theoretically informed topic guide. Analysis of interviews was conducted using an inductive thematic analysis approach. Results: Interviews were conducted with 32 participants who had either accepted or declined the NHS-digital-DPP. In total, 7 overarching themes were identified as important factors in both decisions to take up and to engage with the NHS-digital-DPP. These were knowledge and understanding, referral process, self-efficacy, self-identity, motivation and support, advantages of digital service, and reflexive monitoring. Perceptions of accessibility and convenience of the NHS-digital-DPP were particularly important for uptake, and barriers in terms of the referral process and health care professionals’ engagement were reported. Specific digital features including health coaches and monitoring tools were important for engagement. Conclusions: This study adds to the literature on factors that influence the uptake of and engagement with digital-DPPs and suggests that digital-DPPs can overcome many barriers to the uptake of face-to-face diabetes prevention programs in supporting lifestyle changes aimed at diabetes prevention. %M 36853751 %R 10.2196/40961 %U https://www.jmir.org/2023/1/e40961 %U https://doi.org/10.2196/40961 %U http://www.ncbi.nlm.nih.gov/pubmed/36853751 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e40937 %T Digital Behavioral Activation Interventions During the Perinatal Period: Scoping Review %A Mancinelli,Elisa %A Dell'Arciprete,Gaia %A Pattarozzi,Davide %A Gabrielli,Silvia %A Salcuni,Silvia %+ Department of Developmental and Socialization Psychology, University of Padova, Via Venezia 8, Padova, 35121, Italy, 39 3342799698, elisa.mancinelli@phd.unipd.it %K behavioral activation %K eHealth %K perinatal care %K depression symptoms %K scoping review %K mobile phone %D 2023 %7 28.2.2023 %9 Review %J JMIR Pediatr Parent %G English %X Background: Pregnancy is a complex period that implies many biopsychosocial changes, and the way women adapt to these changes impacts their well-being and the chances of developing mental health problems. During the perinatal period, women have expressed a preference for support delivered on the web. In this regard, interventions such as behavioral activation (BA), which are brief and structured psychosocial interventions, seem particularly suited to be delivered through digital solutions. Objective: This study aimed to map the literature investigating digital BA interventions deployed during the perinatal period. We paid particular attention to the methodological underpinnings of the studies, the potential impact of BA interventions on symptoms other than depression, and the existence of differences occurring when these interventions were administered during pregnancy versus the postpartum period. Methods: A systematic search compliant with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews) guidelines was conducted considering 5 bibliographic databases; reference lists and key journals were also screened by 2 independent authors following a double-blind approach. Results: A total of 7 studies published between 2013 and 2022 were included. In total, 2 studies were protocols for randomized controlled trials, 5 were empirical studies, and 1 was a qualitative study. All studies focused on the postpartum period, except for 1 that focused on the broader perinatal period. Promising effects on depression symptoms were reported but not on other psychosocial symptoms. Low intervention adherence has emerged, whereas the usability associated with the digital means used to deploy interventions was scarcely addressed; moreover, information on the digital platforms used was poorly reported overall. Conclusions: Our findings highlight the scarcity and preliminary nature of digital BA interventions deployed during the perinatal period, where the focus seems more on treatment rather than prevention. Moreover, future studies should also consider and address usability and user engagement, given their relevance to intervention efficacy. %M 36853756 %R 10.2196/40937 %U https://pediatrics.jmir.org/2023/1/e40937 %U https://doi.org/10.2196/40937 %U http://www.ncbi.nlm.nih.gov/pubmed/36853756 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43775 %T Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis %A Teepe,Gisbert Wilhelm %A Kowatsch,Tobias %A Hans,Felix Patricius %A Benning,Leo %+ University Emergency Center, Medical Center - University of Freiburg, Sir-Hans-A.-Krebs-Strasse, Freiburg, 79106, Germany, 49 761 270 18409, leo.benning@uniklinik-freiburg.de %K digital therapeutics %K digital health %K musculoskeletal diseases %K exercise training %D 2023 %7 27.2.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Musculoskeletal conditions are the main drivers of global disease burden and cause significant direct and indirect health care costs. Digital health applications improve the availability of and access to adequate care. The German health care system established a pathway for the approval of “Digitale Gesundheitsanwendungen” (DiGAs; Digital Health Applications) as collectively funded medical services through the “Digitale-Versorgung-Gesetz” (Digital Health Care Act) in 2019. Objective: This article presents real-world prescription data collected through the smartphone-based home exercise program “Vivira,” a fully approved DiGA, regarding its effect on self-reported pain intensity and physical inability in patients with unspecific and degenerative pain in the back, hip, and knee. Methods: This study included 3629 patients (71.8% [2607/3629] female; mean age 47 years, SD 14.2 years). The primary outcome was the self-reported pain score, which was assessed with a verbal numerical rating scale. The secondary outcomes were self-reported function scores. To analyze the primary outcome, we used a 2-sided Skillings-Mack test. For function scores, a time analysis was not feasible; therefore, we calculated matched pairs using the Wilcoxon signed-rank test. Results: Our results showed significant reductions in self-reported pain intensity after 2, 4, 8, and 12 weeks in the Skillings-Mack test (T3628=5308; P<.001). The changes were within the range of a clinically relevant improvement. Function scores showed a generally positive yet more variable response across the pain areas (back, hip, and knee). Conclusions: This study presents postmarketing observational data from one of the first DiGAs for unspecific and degenerative musculoskeletal pain. We noted significant improvements in self-reported pain intensity throughout the observation period of 12 weeks, which reached clinical relevance. Additionally, we identified a complex response pattern of the function scores assessed. Lastly, we highlighted the challenges of relevant attrition at follow-up and the potential opportunities for evaluating digital health applications. Although our findings do not have confirmatory power, they illustrate the potential benefits of digital health applications to improve the availability of and access to medical care. Trial Registration: German Clinical Trials Register DRKS00024051; https://drks.de/search/en/trial/DRKS00024051 %M 36848211 %R 10.2196/43775 %U https://www.jmir.org/2023/1/e43775 %U https://doi.org/10.2196/43775 %U http://www.ncbi.nlm.nih.gov/pubmed/36848211 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43502 %T Feasibility and Acceptability of an Internet of Things–Enabled Sedentary Behavior Intervention: Mixed Methods Study %A Huang,Yitong %A Benford,Steve %A Li,Benqian %A Price,Dominic %A Blake,Holly %+ School of Media and Communication, Shanghai Jiaotong University, 800 Dongchuan Road, Shanghai, 200240, China, 86 21 34205808, huang.yitong@foxmail.com %K internet of things %K health communication %K pervasive media %K ubiquitous computing %K smart objects %K wearable device %K behavior change wheel %K digital intervention %K sedentary behavior %K workplace intervention %K employee well-being %D 2023 %7 27.2.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Encouraging office workers to break up prolonged sedentary behavior (SB) at work with regular microbreaks can be beneficial yet challenging. The Internet of Things (IoT) offers great promise for delivering more subtle and hence acceptable behavior change interventions in the workplace. We previously developed an IoT-enabled SB intervention, called WorkMyWay, by applying a combination of theory-informed and human-centered design approaches. According to the Medical Research Council’s framework for developing and evaluating complex interventions such as WorkMyWay, process evaluation in the feasibility phase can help establish the viability of novel modes of delivery and identify facilitators and barriers to successful delivery. Objective: This study aims to evaluate the feasibility and acceptability of the WorkMyWay intervention and its technological delivery system. Methods: A mixed methods approach was adopted. A sample of 15 office workers were recruited to use WorkMyWay during work hours for 6 weeks. Questionnaires were administered before and after the intervention period to assess self-report occupational sitting and physical activity (OSPA) and psychosocial variables theoretically aligned with prolonged occupational SB (eg, intention, perceived behavioral control, prospective memory and retrospective memory of breaks, and automaticity of regular break behaviors). Behavioral and interactional data were obtained through the system database to determine adherence, quality of delivery, compliance, and objective OSPA. Semistructured interviews were conducted at the end of the study, and a thematic analysis was performed on interview transcripts. Results: All 15 participants completed the study (attrition=0%) and on average used the system for 25 tracking days (out of a possible 30 days; adherence=83%). Although no significant change was observed in either objective or self-report OSPA, postintervention improvements were significant in the automaticity of regular break behaviors (t14=2.606; P=.02), retrospective memory of breaks (t14=7.926; P<.001), and prospective memory of breaks (t14=–2.661; P=.02). The qualitative analysis identified 6 themes, which lent support to the high acceptability of WorkMyWay, though delivery was compromised by issues concerning Bluetooth connectivity and factors related to user behaviors. Fixing technical issues, tailoring to individual differences, soliciting organizational supports, and harnessing interpersonal influences could facilitate delivery and enhance acceptance. Conclusions: It is acceptable and feasible to deliver an SB intervention with an IoT system that involves a wearable activity tracking device, an app, and a digitally augmented everyday object (eg, cup). More industrial design and technological development work on WorkMyWay is warranted to improve delivery. Future research should seek to establish the broad acceptability of similar IoT-enabled interventions while expanding the range of digitally augmented objects as the modes of delivery to meet diverse needs. %M 36848183 %R 10.2196/43502 %U https://www.jmir.org/2023/1/e43502 %U https://doi.org/10.2196/43502 %U http://www.ncbi.nlm.nih.gov/pubmed/36848183 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e40789 %T Artificial Intelligence–Based Chatbots for Promoting Health Behavioral Changes: Systematic Review %A Aggarwal,Abhishek %A Tam,Cheuk Chi %A Wu,Dezhi %A Li,Xiaoming %A Qiao,Shan %+ Department of Health Promotion, Education and Behavior, Arnold School of Public Health, University of South Carolina, 915 Greene St, Columbia, SC, 29201, United States, 1 803 777 6844, SHANQIAO@mailbox.sc.edu %K chatbot %K artificial intelligence %K AI %K health behavior change %K engagement %K efficacy %K intervention %K feasibility %K usability %K acceptability %K mobile phone %D 2023 %7 24.2.2023 %9 Review %J J Med Internet Res %G English %X Background: Artificial intelligence (AI)–based chatbots can offer personalized, engaging, and on-demand health promotion interventions. Objective: The aim of this systematic review was to evaluate the feasibility, efficacy, and intervention characteristics of AI chatbots for promoting health behavior change. Methods: A comprehensive search was conducted in 7 bibliographic databases (PubMed, IEEE Xplore, ACM Digital Library, PsycINFO, Web of Science, Embase, and JMIR publications) for empirical articles published from 1980 to 2022 that evaluated the feasibility or efficacy of AI chatbots for behavior change. The screening, extraction, and analysis of the identified articles were performed by following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Results: Of the 15 included studies, several demonstrated the high efficacy of AI chatbots in promoting healthy lifestyles (n=6, 40%), smoking cessation (n=4, 27%), treatment or medication adherence (n=2, 13%), and reduction in substance misuse (n=1, 7%). However, there were mixed results regarding feasibility, acceptability, and usability. Selected behavior change theories and expert consultation were used to develop the behavior change strategies of AI chatbots, including goal setting, monitoring, real-time reinforcement or feedback, and on-demand support. Real-time user-chatbot interaction data, such as user preferences and behavioral performance, were collected on the chatbot platform to identify ways of providing personalized services. The AI chatbots demonstrated potential for scalability by deployment through accessible devices and platforms (eg, smartphones and Facebook Messenger). The participants also reported that AI chatbots offered a nonjudgmental space for communicating sensitive information. However, the reported results need to be interpreted with caution because of the moderate to high risk of internal validity, insufficient description of AI techniques, and limitation for generalizability. Conclusions: AI chatbots have demonstrated the efficacy of health behavior change interventions among large and diverse populations; however, future studies need to adopt robust randomized control trials to establish definitive conclusions. %M 36826990 %R 10.2196/40789 %U https://www.jmir.org/2023/1/e40789 %U https://doi.org/10.2196/40789 %U http://www.ncbi.nlm.nih.gov/pubmed/36826990 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e40785 %T A Web-Based Self-management App for Living Well With Dementia: User-Centered Development Study %A Lee,Abigail Rebecca %A Csipke,Emese %A Yates,Lauren %A Moniz-Cook,Esme %A McDermott,Orii %A Taylor,Steven %A Stephens,Michael %A Kelleher,Daniel %A Orrell,Martin %+ Institute of Mental Health, School of Medicine, University of Nottingham, Jubilee Campus, Triumph Road, Nottingham, NG7 2TU, United Kingdom, 44 07563254838, abigail.lee19@nhs.net %K dementia %K self-management %K independence %K quality of life %K web-based %K website %K psychosocial %D 2023 %7 24.2.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Self-management, autonomy, and quality of life are key constructs in enabling people to live well with dementia. This population often becomes isolated following diagnosis, but it is important for them to feel encouraged to maintain their daily activities and stay socially active. Promoting Independence in Dementia (PRIDE) fosters social inclusion and greater dementia self-management through an interactive handbook. Objective: This study aimed to develop a paper-based PRIDE manual on a web-based platform. Methods: Two overarching stages were used to create the web-based version of PRIDE. The first was Preliminary Development, which encompassed tendering, preliminary development work, consultations, beta version of the website, user testing and consultation on beta version, and production of the final web-based prototype. The second stage was Development of the Final PRIDE App, which included 2 sprints and further user testing. Results: Through a lengthy development process, modifications were made to app areas such as the log-in process, content layout, and aesthetic appearance. Feedback from the target population was incorporated into the process to achieve a dementia-friendly product. The finished PRIDE app has defined areas for reading dementia-related topics, creating activity plans, and logging these completed activities. Conclusions: The PRIDE app has evolved from its initial prototype into a more dementia-friendly and usable program that is suitable for further testing. The finished version will be tested in a reach, effectiveness, adoption, implementation, and maintenance study, with its potential reach, effectiveness, and adoption explored. Feedback gathered during the reach, effectiveness, adoption, implementation, and maintenance study will lead to any further developments in the app to increase its applicability to the target audience and usability. %M 36826978 %R 10.2196/40785 %U https://humanfactors.jmir.org/2023/1/e40785 %U https://doi.org/10.2196/40785 %U http://www.ncbi.nlm.nih.gov/pubmed/36826978 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e42501 %T Identifying and Categorizing Adverse Events in Trials of Digital Mental Health Interventions: Narrative Scoping Review of Trials in the International Standard Randomized Controlled Trial Number Registry %A Gómez Bergin,Aislinn D %A Valentine,Althea Z %A Rennick-Egglestone,Stefan %A Slade,Mike %A Hollis,Chris %A Hall,Charlotte L %+ National Institute for Health and Care Research MindTech MedTech Co-operative, Institute of Mental Health, School of Medicine, University of Nottingham, University Park, Nottingham, NG7 2TU, United Kingdom, 44 0115 823 2438, charlotte.hall@nottingham.ac.uk %K adverse events %K harm %K psychological interventions %K clinical trials %K review %K digital %K mobile phone %D 2023 %7 22.2.2023 %9 Review %J JMIR Ment Health %G English %X Background: To contextualize the benefits of an intervention, it is important that adverse events (AEs) are reported. This is potentially difficult in trials of digital mental health interventions, where delivery may be remote and the mechanisms of actions less understood. Objective: We aimed to explore the reporting of AEs in randomized controlled trials of digital mental health interventions. Methods: The International Standard Randomized Controlled Trial Number database was searched for trials registered before May 2022. Using advanced search filters, we identified 2546 trials in the category of mental and behavioral disorders. These trials were independently reviewed by 2 researchers against the eligibility criteria. Trials were included where digital mental health interventions for participants with a mental health disorder were evaluated through a completed randomized controlled trial (protocol and primary results publication published). Published protocols and primary results publications were then retrieved. Data were extracted independently by 3 researchers, with discussion to reach consensus when required. Results: Twenty-three trials met the eligibility criteria, of which 16 (69%) included a statement on AEs within a publication, but only 6 (26%) reported AEs within their primary results publication. Seriousness was referred to by 6 trials, relatedness by 4, and expectedness by 2. More interventions delivered with human support (9/11, 82%) than those with only remote or no support (6/12, 50%) included a statement on AEs, but they did not report more AEs. Several reasons for participant dropout were identified by trials that did not report AEs, of which some were identifiable or related to AEs, including serious AEs. Conclusions: There is significant variation in the reporting of AEs in trials of digital mental health interventions. This variation may reflect limited reporting processes and difficulty recognizing AEs related to digital mental health interventions. There is a need to develop guidelines specifically for these trials to improve future reporting. %M 36811940 %R 10.2196/42501 %U https://mental.jmir.org/2023/1/e42501 %U https://doi.org/10.2196/42501 %U http://www.ncbi.nlm.nih.gov/pubmed/36811940 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e44210 %T Layperson-Facilitated Internet-Delivered Cognitive Behavioral Therapy for Homebound Older Adults With Depression: Protocol for a Randomized Controlled Trial %A Kayser,Jay %A Wang,Xu %A Wu,Zhenke %A Dimoji,Asha %A Xiang,Xiaoling %+ School of Social Work, University of Michigan, 1080 S University Ave, Ann Arbor, MI, 48109, United States, 1 (734) 764 3309, jaykayse@umich.edu %K depression %K depressive %K gerontology %K gerontological %K geriatric %K psychotherapy %K older adult %K elder %K home based %K community based %K community living %K homebound %K low-income %K eHealth %K mHealth %K digital mental health %K internet intervention %K iCBT %K CBT %K mental health %K cognitive behavioral therapy %K internet based %K internet delivered %D 2023 %7 22.2.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Depression in older adults has serious biological, psychological, and social consequences. Homebound older adults experience a high burden of depression and significant barriers to accessing mental health treatments. Few interventions to address their specific needs have been developed. Existing treatment modalities can be challenging to scale up, are not tailored to unique population concerns, and require significant staffing support. Technology-assisted, layperson-facilitated psychotherapy has the potential to overcome these challenges. Objective: The aim of this study is to assess the efficacy of a layperson-facilitated internet-delivered cognitive behavioral therapy program tailored for homebound older adults. The novel intervention, Empower@Home, was developed based on user-centered design principles and partnerships between researchers, social service agencies, care recipients, and other stakeholders serving low-income homebound older adults. Methods: This 2-arm, 20-week pilot randomized controlled trial (RCT) with a waitlist control crossover design aims to enroll 70 community-dwelling older adults with elevated depressive symptoms. The treatment group will receive the 10-week intervention immediately, whereas the waitlist control group will cross over and receive the intervention after 10 weeks. This pilot is part of a multiphase project involving a single-group feasibility study (completed in December 2022). This project consists of a pilot RCT (described in this protocol) and an implementation feasibility study running in parallel with the pilot RCT. The primary clinical outcome of the pilot is the change in depressive symptoms after the intervention and at the 20-week postrandomization follow-up. Additional outcomes include acceptability, adherence, and changes in anxiety, social isolation, and quality of life. Results: Institutional review board approval was obtained for the proposed trial in April 2022. Recruitment for the pilot RCT began in January 2023 and is anticipated to end in September 2023. On completion of the pilot trial, we will examine the preliminary efficacy of the intervention on depression symptoms and other secondary clinical outcomes in an intention-to-treat analysis. Conclusions: Although web-based cognitive behavioral therapy programs are available, most programs have low adherence and very few are tailored for older adults. Our intervention addresses this gap. Older adults, particularly those with mobility difficulties and multiple chronic health conditions, could benefit from internet-based psychotherapy. This approach can serve a pressing need in society while being cost-effective, scalable, and convenient. This pilot RCT builds on a completed single-group feasibility study by determining the preliminary effects of the intervention compared with a control condition. The findings will provide a foundation for a future fully-powered randomized controlled efficacy trial. If our intervention is found to be effective, implications extend to other digital mental health interventions and populations with physical disabilities and access restrictions who face persistent disparities in mental health. Trial Registration: ClinicalTrials.gov NCT05593276; https://clinicaltrials.gov/ct2/show/NCT05593276 International Registered Report Identifier (IRRID): PRR1-10.2196/44210 %M 36811937 %R 10.2196/44210 %U https://www.researchprotocols.org/2023/1/e44210 %U https://doi.org/10.2196/44210 %U http://www.ncbi.nlm.nih.gov/pubmed/36811937 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e42861 %T Effects of a Social Media–Based Mind-Body Intervention Embedded With Acupressure and Mindfulness for Stress Reduction Among Family Caregivers of Frail Older Adults: Pilot Randomized Controlled Trial %A Sui,Yufang %A Kor,Patrick Pui Kin %A Li,Mengli %A Wang,Jingjing %+ School of Nursing, The Hong Kong Polytechnic University, FG421, 11 Yuk Choi Road, Hung Hom, Kowloon, Hong Kong, Hong Kong, 852 2766 5622, patrick.kor@polyu.edu.hk %K mind-body intervention %K acupressure %K mindfulness meditation %K social media %D 2023 %7 20.2.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Family caregivers of frail older adults experience high levels of stress. Mind-body interventions (MBIs) focused on caregiver stress are often limited in teaching approaches, difficult to practice, and costly. A social media–based MBI embedded with mindfulness meditation (MM) and self-administered acupressure (SA) may be effective for family caregivers, offer greater usability, and lead to greater adherence. Objective: The aim of this study was to test the feasibility and preliminary effects of a social media–based MBI embedded with MM and SA on family caregivers of frail older adults and to investigate the preliminary effects of the intervention using a pilot randomized controlled trial. Methods: A 2-arm randomized controlled trial design was adopted. Family caregivers of frail older adults (n=64) were randomized into either the intervention group (n=32), receiving 8 weeks of social media–based MM and SA, or the control group (n=32), receiving brief education on caregiving for people with frailty. The primary outcome (caregiver stress) and secondary outcomes (caregiver burden, sleep quality, and mindfulness awareness and attention) were measured using a web-based survey at baseline (T0), immediately after the intervention (T1), and at the 3-month follow-up (T2). Results: The feasibility of the intervention was established with a high attendance rate (87.5%), high usability score (79), and low attrition rate (1.6%). The generalized estimating equation results showed that participants in the intervention group at T1 and T2 experienced a significant improvement in stress reduction (P=.02 and P=.04, respectively), sleep quality (P=.004 and P=.01, respectively), and mindful awareness and attention (P=.006 and P=.02, respectively) compared with the control group. There were no substantial improvements in caregiver burden at T1 and T2 (P=.59 and P=.47, respectively). A focus group session conducted after the intervention had 5 themes: impact on the family caregivers, difficulty in practicing the intervention, the strength of the program, the limitations of the program, and perception of the intervention. Conclusions: The findings support the feasibility and preliminary effects of social media–based MBI embedded with acupressure and MM on reducing stress among family caregivers of frail older people and enhancing sleep quality and mindfulness levels. A future study with a larger and more diverse sample is proposed to evaluate the longer-term effects and generalizability of the intervention. Trial Registration: Chinese Clinical Trial Registry ChiCTR2100049507; http://www.chictr.org.cn/showproj.aspx?proj=128031 %M 36804167 %R 10.2196/42861 %U https://formative.jmir.org/2023/1/e42861 %U https://doi.org/10.2196/42861 %U http://www.ncbi.nlm.nih.gov/pubmed/36804167 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e33185 %T Telemedical Interventions for Chronic Obstructive Pulmonary Disease Management: Umbrella Review %A Koh,Jin Hean %A Chong,Lydia Ching Yee %A Koh,Gerald Choon Huat %A Tyagi,Shilpa %+ Ministry of Health Office for Healthcare Transformation, Ministry of Health, 1 Maritime Square, #12-10 Harborfront Centre, Singapore, 099253, Singapore, 65 6679 3147, gerald.koh@moht.com.sg %K telemedicine %K telehealth %K chronic obstructive pulmonary disease %D 2023 %7 16.2.2023 %9 Review %J J Med Internet Res %G English %X Background: Chronic obstructive pulmonary disease (COPD) is a growing epidemic, with a heavy associated economic burden. Education, physical activity, and pulmonary rehabilitation programs are important aspects of the management of COPD. These interventions are commonly delivered remotely as part of telemedicine interventions. Several systematic reviews and meta-analyses have been conducted to assess the effectiveness of these interventions. However, these reviews often have conflicting conclusions. Objective: We aim to conduct an umbrella review to critically appraise and summarize the available evidence on telemedicine interventions for the management of COPD. Methods: In this umbrella review, the MEDLINE, Embase, PsycINFO, and Cochrane databases were searched from inception to May 2022 for systematic reviews and meta-analyses relating to telemedicine interventions for the management of COPD. We compared odds ratios, measures of quality, and heterogeneity across different outcomes. Results: We identified 7 systematic reviews that met the inclusion criteria. Telemedicine interventions used in these reviews were teletreatment, telemonitoring, and telesupport. Telesupport interventions significantly reduced the number of inpatient days and quality of life. Telemonitoring interventions were associated with significant reductions in respiratory exacerbations and hospitalization rates. Teletreatment showed significant effectiveness in reducing respiratory exacerbations, hospitalization rate, compliance (acceptance and dropout rate), and physical activity. Among studies that used integrated telemedicine interventions, there was a significant improvement in physical activity. Conclusions: Telemedicine interventions showed noninferiority or superiority over the standard of care for the management of COPD. Telemedicine interventions should be considered as a supplement to usual methods of care for the outpatient management of COPD, with the aim of reducing the burden on health care systems. %M 36795479 %R 10.2196/33185 %U https://www.jmir.org/2023/1/e33185 %U https://doi.org/10.2196/33185 %U http://www.ncbi.nlm.nih.gov/pubmed/36795479 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 9 %N %P e39166 %T Using Location Intelligence to Evaluate the COVID-19 Vaccination Campaign in the United States: Spatiotemporal Big Data Analysis %A Li,Qingfeng %A Peng,James Cheng %A Mohan,Diwakar %A Lake,Brennan %A Euler,Alex Ruiz %A Weir,Brian %A Kan,Lena %A Yang,Cui %A Labrique,Alain %+ Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD, 21205, United States, 1 4106141419, qli28@jhu.edu %K COVID-19 vaccine %K vaccine campaign %K big data %K vaccination %K vaccine %K COVID-19 %K uptake %K effectiveness %K barriers %K hesitancy %K health information %D 2023 %7 16.2.2023 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: Highly effective COVID-19 vaccines are available and free of charge in the United States. With adequate coverage, their use may help return life back to normal and reduce COVID-19–related hospitalization and death. Many barriers to widespread inoculation have prevented herd immunity, including vaccine hesitancy, lack of vaccine knowledge, and misinformation. The Ad Council and COVID Collaborative have been conducting one of the largest nationwide targeted campaigns (“It’s Up to You”) to communicate vaccine information and encourage timely vaccination across the United States. More than 300 major brands, digital and print media companies, and community-based organizations support the campaigns to reach distinct audiences. Objective: The goal of this study was to use aggregated mobility data to assess the effectiveness of the campaign on COVID-19 vaccine uptake. Methods: Campaign exposure data were collected from the Cuebiq advertising impact measurement platform consisting of about 17 million opted-in and deidentified mobile devices across the country. A Bayesian spatiotemporal hierarchical model was developed to assess campaign effectiveness through estimating the association between county-level campaign exposure and vaccination rates reported by the Centers for Disease Control and Prevention. To minimize potential bias in exposure to the campaign, the model included several control variables (eg, age, race or ethnicity, income, and political affiliation). We also incorporated conditional autoregressive residual models to account for apparent spatiotemporal autocorrelation. Results: The data set covers a panel of 3104 counties from 48 states and the District of Columbia during a period of 22 weeks (March 29 to August 29, 2021). Officially launched in February 2021, the campaign reached about 3% of the anonymous devices on the Cuebiq platform by the end of March, which was the start of the study period. That exposure rate gradually declined to slightly above 1% in August 2021, effectively ending the study period. Results from the Bayesian hierarchical model indicate a statistically significant positive association between campaign exposure and vaccine uptake at the county level. A campaign that reaches everyone would boost the vaccination rate by 2.2% (95% uncertainty interval: 2.0%-2.4%) on a weekly basis, compared to the baseline case of no campaign. Conclusions: The “It’s Up to You” campaign is effective in promoting COVID-19 vaccine uptake, suggesting that a nationwide targeted mass media campaign with multisectoral collaborations could be an impactful health communication strategy to improve progress against this and future pandemics. Methodologically, the results also show that location intelligence and mobile phone–based monitoring platforms can be effective in measuring impact of large-scale digital campaigns in near real time. %M 36626835 %R 10.2196/39166 %U https://publichealth.jmir.org/2023/1/e39166 %U https://doi.org/10.2196/39166 %U http://www.ncbi.nlm.nih.gov/pubmed/36626835 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43771 %T Implementation of a Web-Based Resilience Enhancement Training for Nurses: Pilot Randomized Controlled Trial %A Henshall,Catherine %A Davey,Zoe %A Srikesavan,Cynthia %A Hart,Liam %A Butcher,Dan %A Cipriani,Andrea %+ Oxford Institute for Nursing, Midwifery and Allied Health Research, Oxford Brookes University, Headington Campus, Marston Road Site, Oxford, OX3 0FL, United Kingdom, 44 7778 428994, chenshall@brookes.ac.uk %K burnout %K COVID-19 %K health care setting %K health care staff %K health care provider %K mental health %K mental well-being %K nurses %K nursing %K pilot trial %K psychological health %K resilience training %K resilience %K web-based health %K web-based training %D 2023 %7 14.2.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Global workforce challenges faced by health care providers are linked to low levels of job satisfaction, recruitment, retention, and well-being, with detrimental impacts on patient care outcomes. Resilience-building programs can provide support for staff who endure highly stressful environments, enhance resilience, and support recruitment and retention, with web-based formats being key to increasing accessibility. Objective: We aimed to examine participants’ engagement with a newly developed Resilience Enhancement Online Training for Nurses (REsOluTioN), explore its acceptability, and compare levels of resilience and psychological well-being in nurses who completed REsOluTioN with those who did not. Methods: We carried out a pilot randomized trial (1:1), conducted at a single site (mental health and community trust in South England) between August 2021 and May 2022. Local research ethics approvals were obtained. Nurses were invited to participate and were randomly assigned to a waitlist group or REsOluTioN group. Training lasted for 4 weeks, consisting of prereading, web-based facilitated sessions, and mentorship support. We evaluated trial engagement, acceptability of training, and pre-post changes in resilience, measured by the Brief Resilience Scale, and psychological well-being, measured by the Warwick Edinburgh Mental Wellbeing Scale. Qualitative participant feedback was collected. Consolidated Standards of Reporting Trials 2010 extension guidelines for reporting pilot and feasibility trials were used. Results: Of 108 participants recruited, 93 completed the study. Participants’ mean age was 44 (SD 10.85) years. Most participants were female (n=95, 88.8%), White (n=95, 88.8%), and worked in community settings (n=91, 85.0%). Sixteen facilitated and 150 mentoring sessions took place. Most REsOluTioN program participants reported the sessions helped improve their resilience (n=24, 72.8%), self-confidence (n=24, 72.7%), ability to provide good patient care (n=25, 75.8%), relationships with colleagues (n=24, 72.7%), and communication skills (n=25, 75.8%). No statistically significant differences between training and control groups and time on well-being (F1,91=1.44, P=.23, partial η2=0.02) and resilience scores (F1,91=0.33, P=.57, partial η2=0.004) were revealed; however, there were positive trends toward improvement in both. Nurse participants engaged with the REsOluTioN program and found it acceptable. Most found web-based training and mentoring useful and enjoyed learning, reflection, networking, and participatory sessions. Conclusions: The REsOluTioN program was acceptable, engaging, perceived as useful, and nurses were keen for it to be implemented to optimize resilience, psychological health, communication, and workplace environments. The study has evidenced that it is acceptable to implement web-based resilience programs with similar design features within busy health care settings, indicating a need for similar programs to be carefully evaluated. Mentorship support may also be a key in optimizing resilience. Trial limitations include small sample size and reduced statistical power; a multicenter randomized controlled trial could test effectiveness of the training on a larger scale. Trial Registration: ClinicalTrials.gov NCT05074563; https://clinicaltrials.gov/ct2/show/NCT05074563 International Registered Report Identifier (IRRID): RR2-10.2196/37015 %M 36787181 %R 10.2196/43771 %U https://www.jmir.org/2023/1/e43771 %U https://doi.org/10.2196/43771 %U http://www.ncbi.nlm.nih.gov/pubmed/36787181 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e43062 %T A Digital Single-Session Intervention Platform for Youth Mental Health: Cultural Adaptation, Evaluation, and Dissemination %A Shroff,Akash %A Roulston,Chantelle %A Fassler,Julia %A Dierschke,Nicole A %A Todd,Jennifer San Pedro %A Ríos-Herrera,Ámbar %A Plastino,Kristen A %A Schleider,Jessica Lee %+ Department of Psychology, Stony Brook University, Psychology B-340, Stony Brook, NY, 17794, United States, 1 9174391872, jessica.schleider@stonybrook.edu %K single-session intervention %K cultural adaptation %K web-based intervention %K adolescents %K mobile phone %D 2023 %7 14.2.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Despite the proliferation of evidence-based digital mental health programs for young people, their low uptake and inconsistent implementation preclude them from benefiting youths at scale. Identifying effective implementation strategies for evidence-based supports is especially critical in regions where treatment access is lowest owing to mental health provider shortages. Objective: The goal of this academic-community partnership, funded by the City of San Antonio Metropolitan Health District, was to culturally adapt, disseminate, and gauge the acceptability and utility of an evidence-based digital mental health platform—Project Youth Empowerment and Support (YES)—among English- and Spanish-speaking youths living in south Texas. Methods: Project YES is an open-access, anonymous platform containing 3 evidence-based, self-guided interventions for youth mental health. Project YES was culturally adapted via focus groups and co-design sessions with San Antonio youths with lived experience of depression and anxiety; translated into Spanish; and disseminated throughout San Antonio, Texas, via community and school partnerships. Results: During the project period (April 2021 to December 2021), 1801 San Antonio youths began and 894 (49.64%) of them completed a 30-minute, single-session intervention within Project YES (aged 11-17 years; n=718, 39.87% male; n=961, 53.36% female; and n=3, 0.17% intersex; n=1477, 82.01% Hispanic; n=77, 4.28% non-Hispanic White; n=113, 6.27% Black; n=28, 1.55% Asian; and n=93, 5.16% other). This completion rate (49.64%) surpassed those previously observed for Project YES (eg, 34% when disseminated via social media). San Antonio youths rated Project YES as highly acceptable across all metrics, both in English and Spanish. In addition, the youths who completed Project YES—ENGLISH reported significant improvements in hopelessness (Cohen d=0.33; P<001), self-hate (Cohen d=0.27; P<001), and perceived agency (Cohen d=0.25; P<001) from before to after the intervention, and the youths who completed Project YES—SPANISH reported significant improvements in self-hate (Cohen d=0.37; P=.049) from before to after the intervention. Conclusions: The results indicate that Project YES—an open-access, free, and anonymous web-based single-session intervention platform—is an acceptable, accessible, and applicable mental health support for English- and Spanish-speaking San Antonio youths. %M 36787180 %R 10.2196/43062 %U https://mental.jmir.org/2023/1/e43062 %U https://doi.org/10.2196/43062 %U http://www.ncbi.nlm.nih.gov/pubmed/36787180 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e42378 %T Understanding Transgender and Gender-Diverse Youth’s Experiences Receiving Care via Telemedicine: Qualitative Interview Study %A Kahn,Nicole F %A Anan,Yomna H %A Bocek,Kevin M %A Christakis,Dimitri A %A Richardson,Laura P %A Pratt,Wanda %A Sequeira,Gina M %+ Center for Child Health, Behavior and Development, Seattle Children's Research Institute, 1920 Terry Ave, Seattle, WA, 98101, United States, 1 206 987 0988, nicole.kahn@seattlechildrens.org %K transgender and gender diverse youth %K adolescent %K telemedicine %K gender-affirming care %K qualitative methods %K COVID-19 %K pandemic %K youth %K gender %K care %K technical %K implementation %K transgender %K telemedicine %K gender diverse %K complexity %D 2023 %7 14.2.2023 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Access to virtual care has increased since the beginning of the COVID-19 pandemic, yet little is known about transgender and gender-diverse (TGD) youth’s experiences and perspectives on receiving care via telemedicine. Objective: The purpose of this study was to explore these experiences to (1) inform necessary changes to the provision of pediatric gender-affirming care and (2) help providers and health systems determine if and how telemedicine should be made available post pandemic. Methods: Youth (aged 14-17 years) who completed a telemedicine visit in the Seattle Children’s Gender Clinic were invited to participate in a semistructured interview exploring perceived advantages or disadvantages of telemedicine and preferred visit modalities. Interview transcriptions were analyzed by 2 research team members using an inductive thematic analysis framework. Results: A total of 15 TGD youth completed an interview. Commonly cited advantages of telemedicine were convenience and comfort with having visits in their own environments. Reported disadvantages included technical issues, discomfort with the impersonal nature, lack of familiarity with the platform, and privacy concerns. Overall, slightly more youth preferred in-person visits over telemedicine, referencing both specific characteristics of the clinical visit (ie, initial vs return and complexity) and proximity to the clinic as reasons for this preference. Although a plurality of TGD youth preferred in-person visits, they also recognized the value of telemedicine and the impact it may have in facilitating access to care. Conclusions: Given the variations in needs and visit complexity, our study supports the provision of both in-person and telemedicine modalities as options for pediatric gender-affirming care. %M 36745775 %R 10.2196/42378 %U https://pediatrics.jmir.org/2023/1/e42378 %U https://doi.org/10.2196/42378 %U http://www.ncbi.nlm.nih.gov/pubmed/36745775 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e41298 %T Effectiveness of Digital Guided Self-help Mindfulness Training During Pregnancy on Maternal Psychological Distress and Infant Neuropsychological Development: Randomized Controlled Trial %A Zhang,Xuan %A Li,Yang %A Wang,Juan %A Mao,Fangxiang %A Wu,Liuliu %A Huang,Yongqi %A Sun,Jiwei %A Cao,Fenglin %+ School of Nursing and Rehabilitation, Shandong University, No.44 Wenhua Xi Road, Jinan, 250012, China, 86 53188382291, caofenglin2008@126.com %K digital %K mobile health %K mHealth %K guided self-help %K psychological distress %K pregnancy %K psychosocial intervention %K mindfulness %K infant %K neuropsychological performance %D 2023 %7 10.2.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Maternal psychological distress during pregnancy is associated with unfavorable outcomes in infants. Mindfulness-based interventions (MBIs) can effectively alleviate psychological distress, but there are often barriers to the access of face-to-face interventions. Objective: This study aimed to investigate the effectiveness of a digital guided self-help (GSH) MBI (GSH-MBI) in reducing maternal psychological distress and improving infant neuropsychological performance. Methods: This was a randomized controlled trial. We recruited 160 women who were 12 to 20 weeks pregnant and exhibited psychological distress. We randomized them into a digital GSH-MBI group and a control group (usual perinatal care). The digital GSH-MBI consisted of a 6-week intervention through a WeChat mini program, with a daily reminder sent to the participants by a research assistant via WeChat. The primary outcomes consisted of maternal psychological distress, including depression, anxiety, and pregnancy-related anxiety symptoms, which were assessed at 6 time points from baseline to 6 months post partum (only pregnancy-related anxiety symptoms were assessed 3 times during pregnancy). The secondary outcomes were infant neuropsychological outcomes, including temperament and developmental behaviors, which were assessed at 6 weeks and 6 months post partum. Results: Compared with the control group, the digital GSH-MBI group showed a significant reduction in depression, anxiety, and pregnancy-related anxiety symptoms. In addition, the scores of the digital GSH-MBI group were lower than those of the control group for the 3 types of infant temperament at 6 weeks post partum, including quality of mood, distractibility, and adaptability. Conclusions: Digital GSH-MBIs are effective in alleviating psychological distress among pregnant women and protecting infant outcomes. Trial Registration: Chinese Clinical Trial Register ChiCTR2000040717; https://www.chictr.org.cn/showproj.aspx?proj=65376 %M 36763452 %R 10.2196/41298 %U https://www.jmir.org/2023/1/e41298 %U https://doi.org/10.2196/41298 %U http://www.ncbi.nlm.nih.gov/pubmed/36763452 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e40836 %T Improving Children’s Sleep Habits Using an Interactive Smartphone App: Community-Based Intervention Study %A Yoshizaki,Arika %A Murata,Emi %A Yamamoto,Tomoka %A Fujisawa,Takashi X %A Hanaie,Ryuzo %A Hirata,Ikuko %A Matsumoto,Sayuri %A Mohri,Ikuko %A Taniike,Masako %+ Molecular Research Center for Children's Mental Development, United Graduate School of Child Development, Osaka University, 2-2-D5 Yamadaoka, Suita, Osaka, 5650871, Japan, 81 6 6879 3863, arika@kokoro.med.osaka-u.ac.jp %K infant sleep %K app %K mHealth %K mobile health %K behavioral intervention %K sleep health %K social implementation %K mobile phone %D 2023 %7 10.2.2023 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Sleep problems are quite common among young children and are often a challenge for parents and a hinderance to children’s development. Although behavioral therapy has proven effective in reducing sleep problems in children, a lack of access to professionals who can provide effective support is a major barrier for many caregivers. Therefore, pediatric sleep experts have begun developing apps and web-based services for caregivers. Despite the substantial influence of cultural and familial factors on children’s sleep, little effort has gone into developing cultural or family-tailored interventions. Objective: This study aimed to examine the effectiveness of the interactive smartphone app “Nenne Navi,” which provides culturally and family-tailored suggestions for improving sleep habits in young Japanese children through community-based long-term trials. The study also aimed to investigate the association between app-driven improvements in sleep and mental development in children. Methods: This study adopted a community-based approach to recruit individuals from the Higashi-Osaka city (Japan) who met ≥1 of the following eligibility criteria for sleep problems: sleeping after 10 PM, getting <9 hours of nighttime sleep, and experiencing frequent nighttime awakenings. A total of 87 Japanese caregivers with young children (mean 19.50, SD 0.70 months) were recruited and assigned to the app use group (intervention group) or the video-only group (control group). Both groups received educational video content regarding sleep health literacy. The caregivers in the intervention group used the app, which provides family-tailored suggestions, once per month for 1 year. Results: A total of 92% (33/36) of the caregivers in the app use group completed 1 year of the intervention. The participants’ overall evaluation of the app was positive. The wake-up time was advanced (base mean 8:06 AM; post mean 7:48 AM; F1,65=6.769; P=.01 and sleep onset latency was decreased (base mean 34.45 minutes; post mean 20.05 minutes; F1,65=23.219; P<.001) significantly in the app use group at the 13th month compared with the video-only group. Moreover, multiple regression analysis showed that decreased social jetlag (β=−0.302; P=.03) and increased sleep onset latency SD (β=.426; P=.02) in children predicted a significant enhancement in the development of social relationships with adults. At 6 months after the completion of the app use, all the caregivers reported continuation of the new lifestyle. Conclusions: The present findings suggest that the app “Nenne Navi” has high continuity in community use and can improve sleep habits in young Japanese children and that interventions for sleep habits of young children may lead to the enhancement of children’s social development. Future studies must focus on the effectiveness of the app in other regions with different regional characteristics and neuroscientific investigations on how changes in sleep impact brain development. %M 36641237 %R 10.2196/40836 %U https://mhealth.jmir.org/2023/1/e40836 %U https://doi.org/10.2196/40836 %U http://www.ncbi.nlm.nih.gov/pubmed/36641237 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 7 %N %P e40283 %T Remotely Delivered Cardiac Rehabilitation Exercise for Coronary Heart Disease: Nonrandomized Feasibility Study %A Giggins,Oonagh M %A Doyle,Julie %A Smith,Suzanne %A Vavasour,Grainne %A Moran,Orla %A Gavin,Shane %A Sojan,Nisanth %A Boyle,Gordon %+ NetwellCASALA, Dundalk Institute of Technology, Dublin Road, Dundalk, A91K584, Ireland, 353 429370200 ext 2114, oonagh.giggins@dkit.ie %K cardiac rehabilitation %K exercise %K coronary heart disease %K CHD %K coronary %K cardiovascular %K virtual rehabilitation %K remote rehabilitation %K digital health %K heart %K rehabilitation %K cardiac %K digital platform %K digital %K intervention %K program %K physical activity %K fitness %D 2023 %7 10.2.2023 %9 Original Paper %J JMIR Cardio %G English %X Background: Exercise-based cardiac rehabilitation (CR) is recommended for coronary heart disease (CHD). However, poor uptake of and poor adherence to CR exercise programs have been reported globally. Delivering CR exercise classes remotely may remove some of the barriers associated with traditional hospital- or center-based CR. Objective: We have developed a bespoke platform, Eastern Corridor Medical Engineering Centre–Cardiac Rehabilitation (ECME-CR), to support remotely delivered CR exercise. This pilot trial sought to test the ECME-CR platform and examine the efficacy and feasibility of a remote CR exercise program compared to a traditional center-based program. Methods: In all, 21 participants with CHD were recruited and assigned to either the intervention or control group. Both groups performed the same 8-week exercise program. Participants in the intervention group took part in web-based exercise classes and used the ECME-CR platform during the intervention period, whereas participants in the control group attended in-person classes. Outcomes were assessed at baseline and following the 8-week intervention period. The primary outcome measure was exercise capacity, assessed using a 6-minute walk test (6MWT). Secondary outcomes included measurement of grip strength, self-reported quality of life, heart rate, blood pressure, and body composition. A series of mixed between-within subjects ANOVA were conducted to examine the mean differences in study outcomes between and within groups. Participant adherence to the exercise program was also analyzed. Results: In all, 8 participants (male: n=5; age: mean 69.7, SD 7.2 years; height: mean 163.9, SD 5.4 cm; weight: mean 81.6, SD 14.1 kg) in the intervention group and 9 participants (male: n=9; age: mean 69.8, SD 8.2 years; height: mean 173.8, SD 5.2 cm; weight: mean 94.4, SD 18.0 kg) in the control group completed the exercise program. Although improvements in 6MWT distance were observed from baseline to follow-up in both the intervention (mean 490.1, SD 80.2 m to mean 504.5, SD 93.7 m) and control (mean 510.2, SD 48.3 m to mean 520.6, SD 49.4 m) group, no significant interaction effect (F1,14=.026; P=.87) nor effect for time (F1,14=2.51; P=.14) were observed. No significant effects emerged for any of the other secondary end points (all P>.0275). Adherence to the exercise program was high in both the intervention (14.25/16, 89.1%) and control (14.33/16, 89.6%) group. No adverse events or safety issues were reported in either group during the study. Conclusions: This pilot trial did not show evidence of significant positive effect for either the remotely delivered or center-based program. The 6MWT may not have been sufficiently sensitive to identify a change in this cohort of participants with stable CHD. This trial does provide evidence that remote CR exercise, supported with digital self-monitoring, is feasible and may be considered for individuals less likely to participate in traditional center-based programs. International Registered Report Identifier (IRRID): RR2-10.2196/31855 %M 36763453 %R 10.2196/40283 %U https://cardio.jmir.org/2023/1/e40283 %U https://doi.org/10.2196/40283 %U http://www.ncbi.nlm.nih.gov/pubmed/36763453 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e42892 %T Parent-Reported Use of Pediatric Primary Care Telemedicine: Survey Study %A Ray,Kristin N %A Wittman,Samuel R %A Burns,Sarah %A Doan,Tran T %A Schweiberger,Kelsey A %A Yabes,Jonathan G %A Hanmer,Janel %A Krishnamurti,Tamar %+ Department of Pediatrics, University of Pittsburgh, 3414 Fifth Avenue, Pittsburgh, PA, 15213, United States, 1 4126927518, knr16@pitt.edu %K telehealth %K telemedicine %K pediatrics %K primary care %D 2023 %7 9.2.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Telemedicine delivered from primary care practices became widely available for children during the COVID-19 pandemic. Objective: Focusing on children with a usual source of care, we aimed to examine factors associated with use of primary care telemedicine. Methods: In February 2022, we surveyed parents of children aged ≤17 years on the AmeriSpeak panel, a probability-based panel of representative US households, about their children’s telemedicine use. We first compared sociodemographic factors among respondents who did and did not report a usual source of care for their children. Among those reporting a usual source of care, we used Rao-Scott F tests to examine factors associated with parent-reported use versus nonuse of primary care telemedicine for their children. Results: Of 1206 respondents, 1054 reported a usual source of care for their children. Of these respondents, 301 of 1054 (weighted percentage 28%) reported primary care telemedicine visits for their children. Factors associated with primary care telemedicine use versus nonuse included having a child with a chronic medical condition (87/301, weighted percentage 27% vs 113/753, 15%, respectively; P=.002), metropolitan residence (262/301, weighted percentage 88% vs 598/753, 78%, respectively; P=.004), greater internet connectivity concerns (60/301, weighted percentage 24% vs 116/753, 16%, respectively; P=.05), and greater health literacy (285/301, weighted percentage 96% vs 693/753, 91%, respectively; P=.005). Conclusions: In a national sample of respondents with a usual source of care for their children, approximately one-quarter reported use of primary care telemedicine for their children as of 2022. Equitable access to primary care telemedicine may be enhanced by promoting access to primary care, sustaining payment for primary care telemedicine, addressing barriers in nonmetropolitan practices, and designing for lower health-literacy populations. %M 36757763 %R 10.2196/42892 %U https://www.jmir.org/2023/1/e42892 %U https://doi.org/10.2196/42892 %U http://www.ncbi.nlm.nih.gov/pubmed/36757763 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e39076 %T Effectiveness of Telerehabilitation Interventions for Self-management of Tinnitus: Systematic Review %A Demoen,Sara %A Chalimourdas,Antonios %A Timmermans,Annick %A Van Rompaey,Vincent %A Vanderveken,Olivier M %A Jacquemin,Laure %A Schlee,Winfried %A Marneffe,Wim %A Luyten,Janis %A Gilles,Annick %A Michiels,Sarah %+ Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Martelarenlaan 42, Hasselt, 3500, Belgium, 32 11269244, sara.demoen@uhasselt.be %K tinnitus %K audiology %K systematic review %K telerehabilitation %K self-management %K intervention %K quality of life %K internet %K self-help %K mobile phone %D 2023 %7 9.2.2023 %9 Review %J J Med Internet Res %G English %X Background: Tinnitus is a highly prevalent symptom affecting 10%-20% of the adult population. Most patients with tinnitus have chronic tinnitus, which can directly or indirectly disrupt their daily life and negatively affect the health-related quality of life. Therefore, patients with tinnitus are frequently in need of costly and time-consuming treatments. As an answer, telerehabilitation interventions are on a rise to promote self-management in patients with tinnitus and reduce their dependency on in-person care. Objective: This systematic review aimed to provide an overview of the research concerning the effectiveness of telerehabilitation interventions for self-management of tinnitus. Methods: This systematic review adheres to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Studies were eligible for inclusion if study participants were adult patients with complaints of primary subjective tinnitus and the study intervention comprised any possible telerehabilitation form for the self-management of tinnitus complaints. A search for eligible studies was conducted on PubMed, ScienceDirect, Scopus, Web of Science, and Cochrane Library. The Cochrane Risk of Bias 2 tool was used to the assess risk of bias. Results: In total, 29 articles were found eligible, and of these, 5 (17%) studied multiple telerehabilitation forms. Internet-based cognitive behavioral treatment with guidance by a psychologist or audiologist was examined in 17 studies (n=1767), internet-based cognitive behavioral treatment without guidance was examined in 4 studies (n=940), self-help manuals were examined in 1 study (n=72), technological self-help devices were examined in 2 studies (n=82), smartphone apps were examined in 8 studies (n=284), and other internet-based interventions were examined in 2 studies (n=130). These rehabilitation categories were proven to be effective in decreasing tinnitus severity and relieving tinnitus distress as measured by tinnitus questionnaires such as Tinnitus Functional Index, Tinnitus Handicap Inventory, or Tinnitus Reactions Questionnaire. However, dropout rates were often high (range 4%-71.4%). All studies reported between some concerns and high concerns of risk of bias, resulting in low to moderate certainty levels. Conclusions: Overall, there is low to moderate quality evidence that telerehabilitation interventions effectively reduce tinnitus severity and distress. These interventions form a possible tool to improve the self-management capacities of the patient and the accessibility of tinnitus care as a replacement or an addition to in-person care. Nevertheless, barriers such as lack of time, engagement, motivation, and openness of the patient causing high dropout should be considered. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42021285450; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=285450 %M 36757768 %R 10.2196/39076 %U https://www.jmir.org/2023/1/e39076 %U https://doi.org/10.2196/39076 %U http://www.ncbi.nlm.nih.gov/pubmed/36757768 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e43160 %T Effects of a Smartphone App on Fruit and Vegetable Consumption Among Saudi Adolescents: Randomized Controlled Trial %A Shatwan,Israa M %A Alhefani,Rabab S %A Bukhari,Mawadah F %A Hanbazazah,Danah A %A Srour,Jumanah K %A Surendran,Shelini %A Aljefree,Najlaa M %A Almoraie,Noha M %+ Food and Nutrition Department, Human Sciences and Design Faculty, King Abdulaziz University, Abdulalah Suliman Street, 3270, Jeddah, 6269, Saudi Arabia, 966 535619144, eshatwan@kau.edu.sa %K smartphone app %K fruit and vegetable consumption %K Saudi Arabia %K adolescents %K nutrition %K health outcome %K digital health intervention %K digital health app %K pediatrics %K youth %D 2023 %7 9.2.2023 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Dietary patterns and nutritional status during adolescence have a direct effect on future health outcomes. Objective: This study aimed to promote fruit and vegetable intake among adolescents using a smartphone app called MyPlate. Methods: This randomized intervention study was conducted in an urban area of Jeddah, Saudi Arabia. We included 104 adolescents aged 13 to 18 years, who were randomized into intervention (n=55) or control (n=49) arms. We examined the effects of MyPlate on fruit and vegetable intake over 6 weeks in the intervention group. Pre- and postintervention questionnaires were used in the intervention and control groups. Results: The control group showed a significant increase in fruit consumption scores between baseline (1.15, SD 0.68) and postintervention (1.64, SD 0.98; P=.01), but no significant difference in vegetable consumption scores was observed before (1.44, SD 0.97) and after intervention (1.55, SD 0.90; P=.54). However, there was no significant difference between scores at baseline and after 6 weeks of using the smartphone app for fruit (1.48, SD 0.99 and 1.70, SD 1.11, respectively; P=.31) or vegetables (1.50, SD 0.97 and 1.43, SD 1.03, respectively; P=.30) in the intervention group. Our findings showed no significant impact of using a smartphone app on fruit and vegetable consumption. Conclusions: These findings suggest that a smartphone app did not significantly improve fruit and vegetable intake among adolescents. Trial Registration: ClinicalTrials.gov NCT05692765; https://clinicaltrials.gov/ct2/show/NCT05692765 %M 36757770 %R 10.2196/43160 %U https://pediatrics.jmir.org/2023/1/e43160 %U https://doi.org/10.2196/43160 %U http://www.ncbi.nlm.nih.gov/pubmed/36757770 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e42390 %T Comparing the Feasibility and Acceptability of a Virtual Human, Teletherapy, and an e-Manual in Delivering a Stress Management Intervention to Distressed Adult Women: Pilot Study %A Loveys,Kate %A Antoni,Michael %A Donkin,Liesje %A Sagar,Mark %A Broadbent,Elizabeth %+ Department of Psychological Medicine, The University of Auckland, Level 3, Building 507, 22-30 Park Avenue, Grafton, Auckland, 1023, New Zealand, 64 93737599 ext 86756, e.broadbent@auckland.ac.nz %K stress %K cognitive behavioral stress management %K telehealth %K conversational agent %K virtual human %K e-manual %K pilot randomized controlled trial %D 2023 %7 9.2.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Virtual humans (VHs), teletherapy, and self-guided e-manuals may increase the accessibility of psychological interventions. However, there is limited research on how these technologies compare in terms of their feasibility and acceptability in delivering stress management interventions. Objective: We conducted a preliminary comparison of the feasibility and acceptability of a VH, teletherapy, and an e-manual at delivering 1 module of cognitive behavioral stress management (CBSM) to evaluate the feasibility of the trial methodology in preparation for a future randomized controlled trial (RCT). Methods: A pilot RCT was conducted with a parallel, mixed design. A community sample of distressed adult women were randomly allocated to receive 1 session of CBSM involving training in cognitive and behavioral techniques by a VH, teletherapy, or an e-manual plus homework over 2 weeks. Data were collected on the feasibility of the intervention technologies (technical support and homework access), trial methods (recruitment methods, questionnaire completion, and methodological difficulty observations), intervention acceptability (intervention completion, self-report ratings, therapist rapport, and trust), and acceptability of the trial methods (self-report ratings and observations). Qualitative data in the form of written responses to open-ended questions were collected to enrich and clarify the findings on intervention acceptability. Results: Overall, 38 participants’ data were analyzed. A VH (n=12), teletherapy (n=12), and an e-manual (n=14) were found to be feasible and acceptable for delivering 1 session of CBSM to distressed adult women based on the overall quantitative and qualitative findings. Technical difficulties were minimal and did not affect intervention completion, and no significant differences were found between the conditions (P=.31). The methodology was feasible, although improvements were identified for a future trial. All conditions achieved good satisfaction and perceived engagement ratings, and no significant group differences were found (P>.40). Participants had similar willingness to recommend each technology (P=.64). There was a nonsignificant trend toward participants feeling more open to using the VH and e-manual from home than teletherapy (P=.10). Rapport (P<.001) and trust (P=.048) were greater with the human teletherapist than with the VH. The qualitative findings enriched the quantitative results by revealing the unique strengths and limitations of each technology that may have influenced acceptability. Conclusions: A VH, teletherapy, and a self-guided e-manual were found to be feasible and acceptable methods of delivering 1 session of a stress management intervention to a community sample of adult women. The technologies were found to have unique strengths and limitations that may affect which works best for whom and in what circumstances. Future research should test additional CBSM modules for delivery by these technologies and conduct a larger RCT to compare their feasibility, acceptability, and effectiveness when delivering a longer home-based stress management program. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620000859987; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380114&isReview=true %M 36757790 %R 10.2196/42390 %U https://formative.jmir.org/2023/1/e42390 %U https://doi.org/10.2196/42390 %U http://www.ncbi.nlm.nih.gov/pubmed/36757790 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e42572 %T Designing and Developing an eHealth Program for Patients With Persistent Physical Symptoms: Usability Study %A Christensen,Oliver Rønn %A Hedegaard,Leonora %A Rask,Mette Trøllund %A Clemensen,Jane %A Frostholm,Lisbeth %A Rosendal,Marianne %+ Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Palle Juul Jensens Boulevard 11, Aarhus N, 8200, Denmark, 45 26540918, oliver.ronn.christensen@gmail.com %K eHealth %K digital health %K medically unexplained symptom %K persistent physical symptom %K self-management %K usability %K physical symptom %K persistent symptom %K unexplained symptom %K symptom management %K unguided %K thinking aloud %K think aloud %D 2023 %7 8.2.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Patients with persistent physical symptoms presenting in primary care are often affected by multiple symptoms and reduced functioning. The medical and societal costs of these patients are high, and there is a need for new interventions tailored to both the patients and health care system. Objective: This study aimed to examine the usability of an unguided, self-help treatment program, “My Symptoms,” developed to assist patients and general practitioners in symptom management. Methods: In all, 11 users (4 patients with persistent physical symptoms and 7 laypeople) participated in web-based thinking-aloud interviews involving the performance of predefined tasks in the program. Thematic analysis was used to categorize the severity of usability issues. General usability heuristics were cross-referenced with the usability issues. Results: The analysis identified important usability issues related to functionality, navigation, and content. The study shows how therapeutic knowledge in some cases was lost in the translation of face-to-face therapy to a digital format. The user testing helped uncover how the functionality of the digital elements and general navigation of the program played a huge part in locating and accessing the needed treatment. Examples of redesign to mediate the therapeutic value in the digital format involving health care professionals, web developers, and users are provided. The study also highlights the differences of involving patients and laypeople in the interviews. Conclusions: Taking the experience of common symptoms as a point of departure, patients and laypeople contributed to finding usability issues on program functionality, navigation, and content to improve the program and make the treatment more accessible to users. %M 36753312 %R 10.2196/42572 %U https://humanfactors.jmir.org/2023/1/e42572 %U https://doi.org/10.2196/42572 %U http://www.ncbi.nlm.nih.gov/pubmed/36753312 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43844 %T Development of a Mobile App to Increase the Uptake of HIV Pre-exposure Prophylaxis Among Latino Sexual Minority Men: Qualitative Needs Assessment %A Cantos,Valeria D %A Hagen,Kimberly %A Duarte,Ana Paula %A Escobar,Carolina %A Batina,Isabella %A Orozco,Humberto %A Rodriguez,Josue %A Camacho-Gonzalez,Andres %A Siegler,Aaron J %+ Division of Infectious Diseases, Emory University School of Medicine, 46 Armstrong Street, Atlanta, GA, 30303, United States, 1 404 251 8717, vcantos@emory.edu %K pre-exposure prophylaxis %K PrEP %K Latino %K sexual minority men %K SMM %K mobile health %K mHealth %K HIV prevention %K HIV %K technology %K minority %K men %K development %K biomedical intervention %K mobile technology %K mobile app %K community %K app %K barrier %K mobile phone %D 2023 %7 8.2.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: HIV disproportionally impacts Latino sexual minority men (SMM). Uptake of pre-exposure prophylaxis (PrEP), an effective biomedical intervention to prevent HIV, is low in this group compared with White SMM. Mobile health technology represents an innovative strategy to increase PrEP uptake among Latino SMM. Objective: We aimed to describe the qualitative process leading to the development of SaludFindr, a comprehensive HIV prevention mobile app aiming to increase PrEP uptake, HIV testing, and condom use by Latino SMM. Methods: We conducted 13 in-depth interviews with Latino SMM living in the Atlanta area to explore their main barriers and facilitators to PrEP uptake and to analyze their opinions of potential SaludFindr app functionalities. To explore potential app functions, we used HealthMindr, an existing HIV prevention app, as a template and added new proposed features intended to address the specific community needs. Results: We identified general PrEP uptake barriers that, although common among non-Latino groups, had added complexities such as the influence of religion and family on stigma. Low perceived PrEP eligibility, intersectional stigma, lack of insurance, cost concerns, and misconceptions about PrEP side effects were described as general barriers. We also identified Latino-specific barriers that predominantly hinder access to existing services, including a scarcity of PrEP clinics that are prepared to provide culturally concordant services, limited availability of Spanish language information related to PrEP access, distrust of peers as credible sources of information, perceived ineligibility for low-cost services owing to undocumented status, fear of immigration authorities, and competing work obligations that prevent PrEP clinic attendance. Health care providers represented a trusted source of information, and 3 provider characteristics were identified as PrEP facilitators: familiarity with prescribing PrEP; being Latino; and being part of lesbian, gay, bisexual, transgender, queer, intersex, and asexual (LGBTQIA+) group or ally. The proposed app was very well accepted, with a particularly high interest in features that facilitate PrEP access, including a tailored list of clinics that meet the community needs and a private platform to seek PrEP information. Spanish language availability and free or low-cost PrEP care represented the 2 main clinic criteria that would facilitate PrEP uptake. Latino representation in clinic staff and providers; clinic perception as a safe space for undocumented patients; and LGBTQIA+ representation was listed as additional criteria. Only 8 of 47 clinics listed on the Centers for Diseases Control and Prevention PrEP locator website for the Atlanta area fulfilled at least 2 main criteria. Conclusions: This study provides further evidence of the substantial PrEP uptake barriers that Latino SMM face; exposes the urgent need to increase the number of accessible PrEP-providing clinics for Latino SMM; and proposes an innovative, community-driven, and mobile technology–based tool as a future intervention to overcome some of these barriers. %M 36625855 %R 10.2196/43844 %U https://formative.jmir.org/2023/1/e43844 %U https://doi.org/10.2196/43844 %U http://www.ncbi.nlm.nih.gov/pubmed/36625855 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e41877 %T The Relationship Between Exercise Habits and Stress Among Individuals With Access to Internet-Connected Home Fitness Equipment: Single-Group Prospective Analysis %A Schneider,Margaret %A Woodworth,Amanda %A Mehrabadi,Milad Asgari %+ Institute for Clinical and Translational Science, University of California, Irvine, 843 Health Science Rd, Irvine, CA, 92697, United States, 1 949 824 8853 ext 48853, mls@uci.edu %K stress %K exercise %K internet-connected home fitness equipment %K physical activity %K healthcare cost %K health care %K psychological well-being %K COVID-19 %K online survey %K user data %K Peloton %D 2023 %7 8.2.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Physical activity (PA) confers numerous benefits to health and health care costs, yet most adults are not meeting recommended PA guidelines. Stress may be a factor that influences PA behavior. Research investigating the impact of stress on PA has yielded inconsistent findings. Most studies find that stress negatively impacts PA, but there is some evidence that habitual exercising buffers this association. Objective: This study aims to examine the relationship between stress and exercise habits among habitual exercisers with internet-connected home fitness equipment (Peloton Bike) during the COVID-19 lockdown. Methods: Participants were recruited through Facebook (N=146) and asked to complete an internet-based survey that assessed COVID-19–related stressors, perceived stress associated with those stressors, and general perceived stress. Self-reported exercise was assessed on the survey using the Godin Leisure-time Exercise Questionnaire (GLTEQ). Participants were also asked for consent to access their Peloton usage data through the Peloton platform. From their usage data, the frequency and duration of cycling classes was calculated for 4 weeks prior to and 12 weeks following the survey. Hierarchical regression equations tested the association between stress reported on the survey and subsequent exercise participation. Exercise participation was quantified both as the frequency and duration of Peloton cycling over the 12 weeks following the survey and as self-reported moderate to vigorous activity on a second survey completed by a subset of participants 12 weeks after the initial survey. Results: There were 146 participants in our Peloton analysis sample and 66 in the self-reported exercise analysis. Peloton user data showed that study participants cycled frequently (mean 5.9 times per week) in the month prior to the initial survey, and that presurvey Peloton use was a strong predictor of exercise frequency (R2=0.57; F2,143=95.27; P<.001) and duration (R2=0.58; F2,143=102.58; P<.001) for the 12 subsequent weeks. Self-reported overall exercise likewise showed that this sample was very active, with an average of more than 8 times per week of moderate to vigorous exercise at the initial survey. Self-reported exercise on the initial survey was a strong predictor of self-reported exercise 12 weeks later (R2=0.31; F1,64=29.03; P<.001). Perceived stress did not impact Peloton cycling duration or frequency (P=.81 and .76, respectively) or self-reported exercise (P=.28). Conclusions: The results suggest that stress did not negatively impact exercise participation among habitually active adults with access to internet-connected home fitness equipment. Habitual exercise may buffer the impact of stress on participation in regular moderate to vigorous activity. Future research should examine the role that the availability of home-based internet-connected exercise equipment may play in this buffering. %M 36719817 %R 10.2196/41877 %U https://formative.jmir.org/2023/1/e41877 %U https://doi.org/10.2196/41877 %U http://www.ncbi.nlm.nih.gov/pubmed/36719817 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e42566 %T Evaluation of an App-Delivered Psychological Flexibility Skill Training Intervention for Medical Student Burnout and Well-being: Randomized Controlled Trial %A Ditton,Elizabeth %A Knott,Brendon %A Hodyl,Nicolette %A Horton,Graeme %A Oldmeadow,Christopher %A Walker,Frederick Rohan %A Nilsson,Michael %+ Centre for Rehab Innovations, University of Newcastle, University Drive, Callaghan, 2308, Australia, 61 2 404 ext 20738, elizabeth.ditton@uon.edu.au %K burnout %K psychological %K burnout interventions %K well-being %K medicine %K medical student %K digital intervention %K app-delivered intervention %K individualized intervention %K randomized controlled trial %K RCT %K randomized %K Acceptance and Commitment Training %K stress %K mobile health %K mHealth %K mobile phone %D 2023 %7 6.2.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Physician burnout is a common problem, with onset frequently occurring during undergraduate education. Early intervention strategies that train medical students in psychological flexibility skills could support well-being and mitigate burnout risks associated with unmodifiable career stressors. There is a need for randomized controlled trials to assess effectiveness. As psychological flexibility varies contextually and among individuals, tailoring interventions may improve outcomes. Smartphone apps can facilitate individualization and accessibility, and the evaluation of this approach is an identified research priority. Objective: This study aimed to evaluate the effectiveness of a stand-alone app–delivered Acceptance and Commitment Training intervention for improving medical students’ self-reported burnout, well-being, psychological flexibility, and psychological distress outcomes. We aimed to explore whether an individualized app would demonstrate benefits over a nonindividualized version. Methods: This parallel randomized controlled trial was conducted with a sample of medical students from 2 Australian universities (N=143). Participants were randomly allocated to 1 of 3 intervention arms (individualized, nonindividualized, and waitlist) using a 1:1:1 allocation ratio. Individualized and nonindividualized participants were blinded to group allocation. The 5-week intervention included an introductory module (stage 1) and on-demand access to short skill training activities (stage 2), which students accessed at their own pace. Stage 2 was either nonindividualized or individualized to meet students’ identified psychological flexibility training needs. Results: The mean differences in change from baseline between the intervention groups and the waitlist group were not statistically significant for burnout outcomes: exhaustion (primary; individualized: −0.52, 95% CI −3.70 to 2.65, P=.75; nonindividualized: 1.60, 95% CI −1.84 to 5.03, P=.37), cynicism (individualized: −1.26, 95% CI −4.46 to 1.94, P=.44; nonindividualized: 1.00, 95% CI −2.45 to 4.46, P=.57), and academic efficacy (individualized: 0.94, 95% CI −0.90 to 2.79, P=.32; nonindividualized: 2.02, 95% CI 0.02-4.03, P=.05). Following the intervention, the individualized group demonstrated improved psychological flexibility (0.50, 95% CI 0.12-0.89; P=.01), reduced inflexibility (0.48, 95% CI −0.92 to −0.04; P=.04), and reduced stress (−6.89, 95% CI −12.01 to 5.99; P=.01), and the nonindividualized group demonstrated improved well-being (6.46, 95% CI 0.49-12.42; P=.04) and stress (−6.36, 95% CI −11.90 to −0.83; P=.03) compared with waitlist participants. Between-group differences for the individualized and nonindividualized arms were not statistically significant. High attrition (75/143, 52.4%) was observed. Conclusions: This trial provides early support for the potential benefits of Acceptance and Commitment Training for medical student well-being and psychological outcomes and demonstrates that psychological flexibility and inflexibility can be trained using a smartphone app. Although postintervention burnout outcomes were not statistically significant, improvements in secondary outcomes could indicate early risk mitigation. Replication studies with larger samples and longer-term follow-up are required, and future research should focus on improving implementation frameworks to increase engagement and optimize individualization methods. Trial Registration: Australian New Zealand Clinical Trials Registry 12621000911897; https://tinyurl.com/2p92cwrw International Registered Report Identifier (IRRID): RR2-10.2196/32992 %M 36745486 %R 10.2196/42566 %U https://mental.jmir.org/2023/1/e42566 %U https://doi.org/10.2196/42566 %U http://www.ncbi.nlm.nih.gov/pubmed/36745486 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 7 %N %P e39097 %T The Impact and Perception of England’s Web-Based Heart Age Test of Cardiovascular Disease Risk: Mixed Methods Study %A Riley,Victoria %A Gidlow,Christopher %A Fedorowicz,Sophia %A Lagord,Catherine %A Thompson,Katherine %A Woolner,Joshua %A Taylor,Rosie %A Clark,Jade %A Lloyd-Harris,Andrew %+ Centre for Health and Development, Staffordshire University, Ashley Building, Leek Road, Stoke-on-Trent, ST4 2DF, United Kingdom, 44 01782294330 ext 4430, c.gidlow@staffs.ac.uk %K heart age %K cardiovascular disease %K CVD prevention %K web-based risk assessment %K CVD risk %K qualitative research %K cross-sectional design %K cardiology %K risk assessment %K cardiovascular risk %K heart health %K user perception %K risk knowledge %K engagement %K web-based %D 2023 %7 6.2.2023 %9 Original Paper %J JMIR Cardio %G English %X Background: It is well documented that individuals struggle to understand cardiovascular disease (CVD) percentage risk scores, which led to the development of heart age as a means of communicating risk. Developed for clinical use, its application in raising public awareness of heart health as part of a self-directed digital test has not been considered previously. Objective: This study aimed to understand who accesses England’s heart age test (HAT) and its effect on user perception, knowledge, and understanding of CVD risk; future behavior intentions; and potential engagement with primary care services. Methods: There were 3 sources of data: routinely gathered data on all individuals accessing the HAT (February 2015 to June 2020); web-based survey, distributed between January 2021 and March 2021; and interviews with a subsample of survey respondents (February 2021 to March 2021). Data were used to describe the test user population and explore knowledge and understanding of CVD risk, confidence in interpreting and controlling CVD risk, and effect on future behavior intentions and potential engagement with primary care. Interviews were analyzed using reflexive thematic analysis. Results: Between February 2015 and June 2020, the HAT was completed approximately 5 million times, with more completions by men (2,682,544/4,898,532, 54.76%), those aged between 50 to 59 years (1,334,195/4,898,532, 27.24%), those from White ethnic background (3,972,293/4,898,532, 81.09%), and those living in the least deprived 20% of areas (707,747/4,898,532, 14.45%). The study concluded with 819 survey responses and 33 semistructured interviews. Participants stated that they understood the meaning of high estimated heart age and self-reported at least some improvement in the understanding and confidence in understanding and controlling CVD risk. Negative emotional responses were provoked among users when estimated heart age did not equate to their previous risk perceptions. The limited information needed to complete it or the production of a result when physiological risk factor information was missing (ie, blood pressure and cholesterol level) led some users to question the credibility of the test. However, most participants who were interviewed mentioned that they would recommend or had already recommended the test to others, would use it again in the future, and would be more likely to take up the offer of a National Health Service Health Check and self-reported that they had made or intended to make changes to their health behavior or felt encouraged to continue to make changes to their health behavior. Conclusions: England’s web-based HAT has engaged large number of people in their heart health. Improvements to England’s HAT, noted in this paper, may enhance user satisfaction and prevent confusion. Future studies to understand the long-term benefit of the test on behavioral outcomes are warranted. %M 36745500 %R 10.2196/39097 %U https://cardio.jmir.org/2023/1/e39097 %U https://doi.org/10.2196/39097 %U http://www.ncbi.nlm.nih.gov/pubmed/36745500 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e41532 %T Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care: Results of a Multicenter Stepped-Wedge Cluster Randomized Trial %A Vis,Christiaan %A Schuurmans,Josien %A Aouizerate,Bruno %A Atipei Craggs,Mette %A Batterham,Philip %A Bührmann,Leah %A Calear,Alison %A Cerga Pashoja,Arlinda %A Christensen,Helen %A Dozeman,Els %A Duedal Pedersen,Claus %A Ebert,David Daniel %A Etzelmueller,Anne %A Fanaj,Naim %A Finch,Tracy L %A Hanssen,Denise %A Hegerl,Ulrich %A Hoogendoorn,Adriaan %A Mathiasen,Kim %A May,Carl %A Meksi,Andia %A Mustafa,Sevim %A O'Dea,Bridianne %A Oehler,Caroline %A Piera-Jiménez,Jordi %A Potthoff,Sebastian %A Qirjako,Gentiana %A Rapley,Tim %A Rosmalen,Judith %A Sacco,Ylenia %A Samalin,Ludovic %A Skjoth,Mette Maria %A Tarp,Kristine %A Titzler,Ingrid %A Van der Eycken,Erik %A van Genugten,Claire Rosalie %A Whitton,Alexis %A Zanalda,Enrico %A Smit,Jan H %A Riper,Heleen %+ Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, Amsterdam, 1081 BT, Netherlands, 31 646098094, p.d.c.vis@vu.nl %K common mental health disorders %K internet-based cognitive behavioral therapy %K iCBT %K implementation strategies %K tailored implementation %K mobile phone %D 2023 %7 3.2.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-based cognitive behavioral therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for strategies that improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective. Tailored implementation is considered as a promising approach. The self-guided integrated theory-based Framework for intervention tailoring strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves identifying local barriers; matching selected barriers to implementation strategies; developing an actionable work plan; and applying, monitoring, and adapting where necessary. Objective: This study aimed to compare the effectiveness of the ItFits-toolkit with implementation-as-usual (IAU) in implementing iCBT services in 12 routine mental health care organizations in 9 countries in Europe and Australia. Methods: A stepped-wedge cluster randomized trial design with repeated measures was applied. The trial period lasted 30 months. The primary outcome was the normalization of iCBT delivery by service providers (therapists, referrers, IT developers, and administrators), which was measured with the Normalization Measure Development as a proxy for implementation success. A 3-level linear mixed-effects modeling was applied to estimate the effects. iCBT service uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. The perceived satisfaction (Client Satisfaction Questionnaire), usability (System Usability Scale), and impact of the ItFits-toolkit by implementers were used to assess the acceptability of the ItFits-toolkit. Results: In total, 456 mental health service providers were included in this study. Compared with IAU, the ItFits-toolkit had a small positive statistically significant effect on normalization levels in service providers (mean 0.09, SD 0.04; P=.02; Cohen d=0.12). The uptake of iCBT by patients was similar to that of IAU. Implementers did not spend more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it. Conclusions: The ItFits-toolkit performed better than the usual implementation activities in implementing iCBT services in routine practice. There is practical utility in the ItFits-toolkit for supporting implementers in developing and applying effective tailored implementation strategies. However, the effect on normalization levels among mental health service providers was small. These findings warrant modesty regarding the effectiveness of self-guided tailored implementation of iCBT services in routine practice. Trial Registration: ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-020-04686-4 %M 36735287 %R 10.2196/41532 %U https://www.jmir.org/2023/1/e41532 %U https://doi.org/10.2196/41532 %U http://www.ncbi.nlm.nih.gov/pubmed/36735287 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e41193 %T Supporting Parents of Children With Type 1 Diabetes: Experiment Comparing Message and Delivery Types %A Holtz,Bree %A Mitchell,Katharine %+ Department of Advertising and Public Relations, College of Communication Arts and Sciences, Michigan State University, 404 Wilson Road, Room 309, East Lansing, MI, 48823, United States, 1 5173030159, bholtz@msu.edu %K caregiving %K children %K development %K diabetes %K diagnosis %K effectiveness %K email %K intervention %K management %K social support %K stress %K support %K type 1 diabetes %D 2023 %7 3.2.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Type 1 diabetes (T1D) is a chronic condition that typically affects young age group people and is estimated to afflict approximately 154,000 people younger than 20 years in the United States. Since T1D typically impacts children, parents must play an active role in helping their child manage the condition. This creates a substantial burden and responsibility for the parents. Objective: This pilot study sought to find ways to help parents with children with T1D in coping with stresses related to managing and monitoring their child’s disease by providing informational support, either about parenting a child with T1D or general parenting messages through different channels. Methods: Parents (N=120) of children with T1D were recruited through an email listserv through local T1D Facebook groups. A total of 102 participants were included in the analysis. We conducted a 2×2 experimental study over an 8-week period to test 2 types of messages (diabetes specific vs general parenting) and the medium in which the messages were delivered (Facebook vs SMS text message). Diabetes behavior, informational support, emotional support, and quality of life were the main outcomes of interest. Results: The results suggested that the participants in the diabetes message groups showed improvement in diabetes behaviors (F1,99=3.69; P=.05) and were more satisfied with the intervention (F3,98=4.59; P=.005). There were no differences between message and medium groups on informational support, emotional support, or quality of life. Conclusions: The results of this study demonstrate that the medium—Facebook or SMS text messaging—does not matter for parents’ perceptions of social support or quality of life. The diabetes message group reported higher levels of disease management. Finally, the groups with the diabetes support messages were more satisfied than those who received general parenting messages. The findings provide starting guidance for the development of social support interventions for this population. %M 36735338 %R 10.2196/41193 %U https://formative.jmir.org/2023/1/e41193 %U https://doi.org/10.2196/41193 %U http://www.ncbi.nlm.nih.gov/pubmed/36735338 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e39969 %T To Act or Not to Act—a Sense of Control Is Important for People With Chronic Obstructive Pulmonary Disease to Increase Physical Activity: Grounded Theory Study %A Marklund,Sarah %A Sörlin,Ann %A Stenlund,Tobias %A Wadell,Karin %A Nyberg,Andre %+ Section of Physiotherapy, Department of Community Medicine and Rehabilitation, Umeå University, Linnaeus väg 9, Umeå, 90736, Sweden, 46 7869835, sarah.marklund@umu.se %K physical activity %K chronic obstructive pulmonary disease %K COPD %K eHealth %K interviews %K eHealth tools %D 2023 %7 3.2.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Among people with chronic obstructive pulmonary disease (COPD), low level of daily physical activity (PA) is the main risk factors for developing cardiovascular, metabolic, and musculoskeletal comorbidities. Increasing PA in people with COPD is complex as PA behavior itself is complex and multifaceted, including personal, physiological, and psychological elements as well as social and environmental factors. Although eHealth solutions such as web-based support or websites have shown positive effects on PA in people with COPD, the results are inconclusive, and it is still unclear how eHealth solutions might be used to support positive changes in PA behavior in people with COPD. Objective: This study aimed to explore the perceptions of increasing objective PA when using a web-based eHealth tool among people with COPD. Methods: This study was part of a pragmatic randomized controlled trial with in-depth interviews between the 3- and 12-month follow-ups. The methodology used was constructivist grounded theory. All sampling included participants from the randomized controlled trial intervention group, that is, participants who had access to the eHealth tool in question and agreed to be contacted for an in-depth interview. Inclusion of participants continued until data saturation was reached, resulting in an inclusion of 13 (n=7, 54% women) participants aged between 49 and 84 years and living in 8 municipalities in Middle and Northern Sweden. Two interviews were conducted face-to-face, and the remaining interviews were conducted via telephone. All interviews were recorded using a Dictaphone. Results: The analysis resulted in 3 main categories: welcoming or not welcoming action, having or lacking resources, and lowering the threshold. The first 2 categories contain barriers and facilitators, whereas the third category contains only facilitators. The categories lead to the more latent theme Perceiving enough control to enable action, meaning that it seems that perceiving the right amount of control is essential to maintain or increase the level of PA when using an eHealth tool among patients with COPD. However, the right amount of control seemed to depend on the individual (and context) in question. Conclusions: The core category indicates that a need for a certain sense of control was interpreted as necessary for increasing the PA level as well as for using an eHealth tool to help increase the PA level. The eHealth tool seemed to strengthen or weaken the perception of control by either providing support or by being too demanding on the user. Perceptions varied depending on other environmental factors. The Fogg Behavior Model illustrated how motivational levels, ability levels, and functional triggers interact within our findings. Thus, this study provides further evidence for the importance of empowering the patients to boost their level of agency and their ability to improve PA levels. International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2019-030788 %M 36735302 %R 10.2196/39969 %U https://formative.jmir.org/2023/1/e39969 %U https://doi.org/10.2196/39969 %U http://www.ncbi.nlm.nih.gov/pubmed/36735302 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e36964 %T The Empowering Role of Web-Based Help Seeking on Depressive Symptoms: Systematic Review and Meta-analysis %A Bizzotto,Nicole %A Marciano,Laura %A de Bruijn,Gert-Jan %A Schulz,Peter Johannes %+ Università della Svizzera italiana, Via Buffi 13, Lugano, 6900, Switzerland, 41 58 666 4724, peter.schulz@usi.ch %K web-based help-seeking %K support groups %K depressive symptoms %K internet %K mental health %K empowerment %D 2023 %7 2.2.2023 %9 Review %J J Med Internet Res %G English %X Background: Most research on web-based help seeking for mental health problems has focused on the antecedents of this behavior. Therefore, little is known about the outcomes of web-based help seeking in general or in specific mental health issues. Objective: This study was a systematic review and meta-analysis of the literature on the antecedents and consequences of web-based help-seeking behaviors for depressive symptoms. Methods: A systematic literature search was carried out in 6 scientific databases, leading to 48 studies (for a total of 314,921 participants) included in the qualitative synthesis and 19 included in the meta-analysis. Results: The results indicated a positive relationship between depressive symptoms and web-based help-seeking behaviors through online support groups (r=0.089; P=.009), and Generation Z (r=0.102; P=.008) tended to participate in support groups more than previous generations. In addition, web-based help seeking was positively related to empowerment (r=0.245; P=.004). Other forms of support reported included the internet and specific self-help tools, but no significant relationships were found with depressive symptoms. Conclusions: More studies examining the outcomes are needed, together with a more rigorous assessment of web-based help-seeking behaviors. Ultimately, we propose a summary framework for the literature on this topic, including the antecedents, patterns of use, and outcomes of web-based help seeking in the context of depressive symptoms. %M 36729571 %R 10.2196/36964 %U https://www.jmir.org/2023/1/e36964 %U https://doi.org/10.2196/36964 %U http://www.ncbi.nlm.nih.gov/pubmed/36729571 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e42611 %T The Use of Sensors to Detect Anxiety for In-the-Moment Intervention: Scoping Review %A Dobson,Rosie %A Li,Linwei Lily %A Garner,Katie %A Tane,Taria %A McCool,Judith %A Whittaker,Robyn %+ National Institute for Health Innovation, University of Auckland, Building 507, Grafton Campus, 22-30 Park Avenue, Grafton, Auckland, 1023, New Zealand, 64 9 373 7599, r.dobson@auckland.ac.nz %K anxiety %K wearables %K sensors %K mental health %K digital mental health %K digital health intervention %K wearable device %D 2023 %7 2.2.2023 %9 Review %J JMIR Ment Health %G English %X Background: With anxiety a growing issue and barriers to accessing support services, there is a need for innovative solutions to provide early intervention. In-the-moment interventions support individuals to recognize early signs of distress and use coping mechanisms to prevent or manage this distress. There is potential for wearable sensors linked to an individual’s mobile phone to provide in-the-moment support tailored to individual needs and physiological responses. Objective: The aim of this scoping review is to examine the role of sensors in detecting the physiological signs of anxiety to initiate and direct interventions for its management. Methods: Relevant studies were identified through searches conducted in Embase, MEDLINE, APA PsycINFO, ProQuest, and Scopus. Studies were identified if they were conducted with people with stress or anxiety or at risk of anxiety and included a wearable sensor providing real-time data for in-the-moment management of anxiety. Results: Of the 1087 studies identified, 11 studies were included in the review, including 5 randomized controlled trials and 6 pilot or pretesting studies. The results showed that most studies successfully demonstrated improvements in their target variables. This included overall anxiety and stress levels, and the implementation of in-the-moment stress and anxiety management techniques such as diaphragmatic breathing. There was wide variation in the types of sensors used, physiological measures, and sensor-linked interventions. Conclusions: This review indicates that sensors are potentially a useful tool in detecting anxiety and facilitating the implementation of a known control mechanism to reduce anxiety and improve mood, but further work is needed to understand the acceptability and effectiveness of this type of intervention. %M 36729590 %R 10.2196/42611 %U https://mental.jmir.org/2023/1/e42611 %U https://doi.org/10.2196/42611 %U http://www.ncbi.nlm.nih.gov/pubmed/36729590 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e34842 %T The Effects of a Web-Based Intervention to Reduce Alcohol Consumption Among Middle-Aged Women: Protocol for a Randomized Controlled Trial %A Miller,Mia %A Wright,Cassandra %A Kuntsche,Emmanuel %A Kuntsche,Sandra %+ Menzies School of Health Research, Charles Darwin University, John Mathews Building Royal Darwin Hospital Campus, 58 Rocklands Dr, Tiwi, Darwin, 0810, Australia, 61 (08) 8946 8600, mia.miller@menzies.edu.au %K alcohol consumption %K web-based %K online intervention %K middle-aged women %K Australia %K intervention %K alcohol research %K alcohol %K ecological momentary assessment %K EMA %D 2023 %7 2.2.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: In the last decade, alcohol consumption among middle-aged women (40-65 years old) in Australia increased, despite declines in overall population consumption. Web-based, brief interventions are promising for reducing alcohol consumption, with efficacy shown in a wide range of populations. However, no published interventions have been designed specifically for and tested with middle-aged women. Objective: This study aims to design and implement a web-based intervention intended to reduce alcohol consumption among middle-aged women. Methods: The study is a 3-arm randomized controlled trial with a web-based intervention plus ecological momentary assessment (EMA) group compared to an EMA-only and a pre-post only control group. The study is aimed at middle-aged women, defined as women aged between 40 and 65 years, who consume alcohol at least weekly or who have consumed 4 or more drinks on 1 occasion in the last month. The intervention aims to reduce alcohol consumption through 4 modules that provide information on the health impacts of alcohol, mindfulness, social influences, and alcohol marketing. Intervention participants will also fill out biweekly EMA assessments. The comparators are EMA-only and pre-post control only. The primary outcome is alcohol consumption at 8 weeks compared between groups. Secondary outcomes are awareness of alcohol-related harms, readiness to change alcohol consumption, health status, mental health, and social support. Results: Ethics approval for this project was received on September 11, 2019. The trial was registered on August 14, 2020. Recruitment has commenced, and the expected results will be available in 2022. Conclusions: This web-based intervention aims to reduce alcohol consumption among middle-aged women, a currently understudied cohort in alcohol research. Trial Registration: Australia New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000814976; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000814976 International Registered Report Identifier (IRRID): DERR1-10.2196/34842 %M 36729575 %R 10.2196/34842 %U https://www.researchprotocols.org/2023/1/e34842 %U https://doi.org/10.2196/34842 %U http://www.ncbi.nlm.nih.gov/pubmed/36729575 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e41262 %T Development of a Digital Behavioral Intervention to Reduce the Consumption of Sugar-Sweetened Beverages Among Rural Appalachian Adults: Multiphased, Human-Centered Design Approach %A Zoellner,Jamie %A Reid,Annie %A Porter,Kathleen %A Frederick,Christina %A Hilgart,Michelle %A Ritterband,Lee %+ Department of Public Health Sciences, School of Medicine, University of Virginia, 16 East Main Street, Suite 101, Christainsburg, VA, 24073, United States, 1 4349624488, jz9q@virginia.edu %K eHealth %K human-centered design %K internet-based intervention %K digital technology %K Model for Internet Interventions %K beverages %K behavioral research %K rural population %K mobile phone %D 2023 %7 1.2.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: To avoid the low engagement and limited efficacy of digital behavioral health interventions, robust human-centered design (HCD) processes are needed. Objective: The primary objective of this study was to describe a flexible, step-by-step HCD process to develop digital behavioral health interventions by illustrating iSIPsmarter as an example. iSIPsmarter is a digital intervention for reducing the consumption of sugar-sweetened beverages (SSBs) that comprises 6 internet-based cores metered out over time to deliver the program content, an integrated SMS text message strategy to engage users in reporting SSB behaviors, and an electronic cellular-enabled scale for in-home weighing. The secondary objective is to illustrate the key components and characteristics of iSIPsmarter that resulted from the HCD process. Methods: The methods were guided by the Model for Internet Interventions and by best practices in HCD and instructional design processes (eg, rapid prototype development and think-aloud protocol). The 3-phased (ie, contextual, prototype testing, end user testing phases) process followed in this study included a series of 13 semistructured one-on-one interviews with 7 advisory team participants from the targeted Appalachian user group. The interviews were content coded by 2 researchers and then deductively coded to the suggested areas of digital behavioral health interventions. Results: The participants provided rich perspectives pertaining to iSIPsmarter’s appearance, behavioral prescriptions, burdens, content, delivery, message, participation, and assessment. These inputs included requests for built-in flexibility to account for varying internet and SMS text message accessibility among users; ideas to resolve the issues and problems encountered when using the prototypes, including those related to navigation and comprehension of content; ideas to enhance personalized feedback to support motivation and goal setting for SSB consumption and weight; and feedback to refine the development of realistic and relatable vignettes. The participants were able to interact with multiple prototype drafts, allowing researchers to capture and incorporate feedback related to the iSIPsmarter dashboard, daily SSB and weight diaries, action planning, core content, interactions, and vignettes. Conclusions: Using scientific models and established processes is critical for building robust and efficacious interventions. By applying an existing model and HCD and instructional design processes, we were able to identify assumptions and address the key areas of the iSIPsmarter intervention that were hypothesized to support users’ engagement and promote behavior change. As evidenced by the rich feedback received from the advisory team members and the resulting iSIPsmarter product, the HCD methodology was instrumental in the development process. Although the final iSIPsmarter content is specific to improving SSB consumption behaviors among adults in rural areas, the intent is that this HCD process will have wide applications in the development of digital behavioral health interventions across multiple geographic and behavioral contexts. %M 36724036 %R 10.2196/41262 %U https://humanfactors.jmir.org/2023/1/e41262 %U https://doi.org/10.2196/41262 %U http://www.ncbi.nlm.nih.gov/pubmed/36724036 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44138 %T Outcomes of a Live Messaging, Blended Care Coaching Program Among Adults With Symptoms of Anxiety: Pragmatic Retrospective Cohort Study %A Owusu,Jocelynn T %A Wang,Pam %A Wickham,Robert E %A Smith,Sarah F %A Lee,Jennifer L %A Chen,Connie %A Lungu,Anita %+ Lyra Health, 287 Lorton Avenue, Burlingame, CA, 94010, United States, 1 877 505 7147, jowusu@lyrahealth.com %K text-based coaching %K anxiety %K blended care %D 2023 %7 1.2.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Anxiety disorders are common and can be debilitating. In addition, various barriers exist that can hinder access to adequate care. Coaching that is grounded in evidence-based interventions and delivered via synchronous (ie, live) text-based messaging could potentially increase the reach of mental health services among populations who select this modality instead of other services (eg, face-to-face coaching and psychotherapy). In addition, the delivery of live messaging coaching within a blended care model has the potential to combine the benefits of coaching with those of evidence-based digital mental health tools. Objective: This real-world study evaluates the anxiety and satisfaction outcomes of live messaging coaching blended with digital tools (ie, digital exercises and activities). Methods: This was a retrospective cohort study of 121 adults with moderate levels of anxiety symptoms at the beginning of coaching (Generalized Anxiety Disorder-7 [GAD-7] scores: range 8-14). Participants received an employer-offered blended messaging coaching (BMC) program, and those who opted to receive all live coaching sessions via text-based messaging were included. Anxiety symptom severity was regularly measured by using the GAD-7 scale. Using growth curve models, the change in GAD-7 scores over the course of BMC was evaluated, as were the effects of text-based coaching sessions on GAD-7 scores. The proportion of participants that had a reliable improvement in anxiety symptom severity (GAD-7 score reduction of ≥4) or subclinical symptom severity (GAD-7 score of <8) at the end of care was also estimated. Participants also self-reported their likelihood of recommending their live messaging coach to someone with similar needs. Results: At baseline, the average GAD-7 score was 9.88 (SD 1.80). Anxiety symptom severity significantly decreased with each week in the BMC program (week: b=−1.04; P<.001), and the rate of decline in anxiety symptom severity decreased over time (week2: b=0.06; P<.001). Each live messaging coaching session was associated with significantly lower anxiety symptom severity during the week of the coaching session (b=−1.56; P<.001) and the week immediately following the session (b=−1.03; P<.001). Overall, 86% (104/121) of participants had subclinical symptom severity or a reliable reduction in anxiety symptom severity by the end of care. Further, 33.1% (40/121) of participants reported coaching satisfaction levels; of the 40 participants in this subset, 37 (92.5%) were likely or extremely likely to recommend their live messaging coach. Conclusions: BMC that provides coaching sessions via live messaging can be beneficial for adults with moderate symptoms of anxiety who qualify for and self-select this care modality. Large-scale studies with longer follow-ups are needed. %M 36724014 %R 10.2196/44138 %U https://formative.jmir.org/2023/1/e44138 %U https://doi.org/10.2196/44138 %U http://www.ncbi.nlm.nih.gov/pubmed/36724014 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43557 %T A Digital Health Intervention for Concussion: Development and Clinical Feasibility Study %A d'Offay,Christine %A Ng,Xin Yi %A Alexander,Laura %A Grant,Alison %A Grahamslaw,Julia %A Pagliari,Claudia %A Reed,Matthew J %A Carson,Alan %A Gillespie,David C %A Jamjoom,Aimun A B %+ Centre for Clinical Brain Sciences, The University of Edinburgh, Chancellors Building, Edinburgh, EH16 4SA, United Kingdom, 44 131 650 1000, v1ajamjo@ed.ac.uk %K concussion %K digital intervention %K behavior change %K feasibility study %D 2023 %7 1.2.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Concussion is a common condition that can lead to a constellation of symptoms that affect quality of life, social integration, and return to work. There are several evidence-based behavioral and psychological interventions that have been found to improve postconcussion symptom burden. However, these are not routinely delivered, and individuals receive limited support during their concussion recovery. Objective: This study aimed to develop and test the feasibility of a digital health intervention using a systematic evidence-, theory-, and person-based approach. Methods: This was a mixed methodology study involving a scoping review (n=21), behavioral analysis, and logic model to inform the intervention design and content. During development, the intervention was optimized with feedback from individuals who had experienced concussions (n=12) and health care professionals (n=11). The intervention was then offered to patients presenting to the emergency department with a concussion (n=50). Participants used the intervention freely and input symptom data as part of the program. A number of outcome measures were obtained, including participant engagement with the intervention, postconcussion symptom burden, and attitudes toward the intervention. A selection of participants (n=15) took part in in-depth qualitative interviews to understand their attitudes toward the intervention and how to improve it. Results: Engagement with the intervention functionality was 90% (45/50) for the symptom diary, 62% (31/50) for sleep time setting, 56% (28/50) for the alcohol tracker, 48% (24/50) for exercise day setting, 34% (17/50) for the thought diary, and 32% (16/50) for the goal setter. Metrics indicated high levels of early engagement that trailed off throughout the course of the intervention, with an average daily completion rate of the symptom diary of 28.23% (494/1750). A quarter of the study participants (13/50, 26%) were classified as high engagers who interacted with all the functionalities within the intervention. Quantitative and qualitative feedback indicated a high level of usability and positive perception of the intervention. Daily symptom diaries (n=494) demonstrated a wide variation in individual participant symptom burden but a decline in average burden over time. For participants with Rivermead scores on completion of HeadOn, there was a strong positive correlation (r=0.86; P<.001) between their average daily HeadOn symptom diary score and their end-of-program Rivermead score. Insights from the interviews were then fed back into development to optimize the intervention and facilitate engagement. Conclusions: Using this systematic approach, we developed a digital health intervention for individuals who have experienced a concussion that is designed to facilitate positive behavior change. Symptom data input as part of the intervention provided insights into postconcussion symptom burden and recovery trajectories. Trial Registration: ClinicalTrials.gov NCT05069948; https://clinicaltrials.gov/ct2/show/NCT05069948 %M 36724010 %R 10.2196/43557 %U https://formative.jmir.org/2023/1/e43557 %U https://doi.org/10.2196/43557 %U http://www.ncbi.nlm.nih.gov/pubmed/36724010 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e40145 %T Web-Based Mind-Body Tactical Resilience Training Program for First Responders: Pre-Post Study Assessing Feasibility, Acceptability, and Usability %A Tan,Leona %A Deady,Mark %A Mead,Olivia %A Foright,Rebecca M %A Brenneman,Eric M %A Yeager,Jamie R %A Bryant,Richard A %A Harvey,Samuel B %+ Black Dog Institute, University of New South Wales, Hospital Road, Randwick, 2031, Australia, 61 290659135, leona.tan@unsw.edu.au %K resilience training %K first responders %K web-based intervention %K mental health %K mind-body %K posttraumatic stress disorder %K PTSD %K prevention %D 2023 %7 1.2.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: First responders report elevated rates of mental disorders, including posttraumatic stress disorder (PTSD), yet many are reluctant to seek care. Preventative resilience training programs attempt to proactively address this issue, and there is evidence showing promise for programs targeting cognitive processes. However, these programs rarely address the physical health conditions associated with PTSD. There is emerging evidence of mind-body exercise training improving PTSD symptoms as well as its associated physical health symptoms. However, the feasibility and acceptability of delivering a web-based mind-body resilience training among first responders are not yet known. Objective: This study aimed to evaluate the feasibility, usability, and acceptability of a web-based mind-body tactical resilience training program designed for first responders. In addition, we explored the preliminary effectiveness of the training program on mental health outcomes, adaptive cognitive strategies, and work productivity. Methods: A total of 42 first responders based in the United States enrolled in the web-based training program. Participants were administered web-based surveys before enrolling in the 6-week web-based program and at the end of the program. The primary outcomes of feasibility were measured using the number of training hours, program adherence rates, and self-reported data on frequency of practice. Acceptability and usability were measured using self-reported data. Secondary outcomes were symptoms of PTSD, psychological distress, emotion regulation, stress mindset, psychological preparedness, and work performance. Results: Overall, the training program was feasible based on the median number of training hours spent on the web-based program (7.57 hours out of an expected total of 6 to 9 hours), and 55% (23/42) of the enrolled participants completed more than half of the program. Although acceptability, usability, and frequency of practice were rated as high, this was based on only 29% (12/42) of the respondents who provided follow-up data. Secondary outcomes showed a significant improvement in the adaptive cognitive strategy of the stress mindset, with a mean difference of –5.42 (SD 4.81; 95% CI −8.475 to −2.358; t11=−3.898; P=.002). All other secondary outcomes were not significant. However, the secondary outcomes were exploratory only, and this study was neither designed nor powered to adequately assess efficacy. Conclusions: These findings suggest that a mind-body tactical resilience training program delivered in a web-based format is feasible and acceptable among first responders; however, further refinements may be required to improve adherence rates. Further research using a larger, more rigorous trial design is warranted to examine the effectiveness of this type of training as a possible prevention or treatment strategy for this population. %M 36724011 %R 10.2196/40145 %U https://formative.jmir.org/2023/1/e40145 %U https://doi.org/10.2196/40145 %U http://www.ncbi.nlm.nih.gov/pubmed/36724011 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e39321 %T The Effect of an eHealth Coaching Program (Smarter Pregnancy) on Attitudes and Practices Toward Periconception Lifestyle Behaviors in Women Attempting Pregnancy: Prospective Study %A Hojeij,Batoul %A Schoenmakers,Sam %A Willemsen,Sten %A van Rossem,Lenie %A Dinnyes,Andras %A Rousian,Melek %A Steegers-Theunissen,Regine PM %+ Department of Obstetrics and Gynecology, Erasmus MC, University Medical Center, Doctor Molewaterplein 40, Rotterdam, 3015 GD, Netherlands, 31 06 124 726 43, r.steegers@erasmusmc.nl %K diet %K lifestyle %K attitudes %K practices %K eHealth %K pregnancy %K Smarter Pregnancy %D 2023 %7 31.1.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Lifestyle behaviors during the periconception period contribute to achievement of a successful pregnancy. Assessment of attitudes and practices toward these modifiable behaviors can aid in identifying gaps in unhealthy lifestyle behaviors with impact on intervention effectiveness. Objective: This study investigates the effectiveness of coaching by the eHealth program Smarter Pregnancy during the periconception period on improvement of attitudes and practices toward fruit and vegetable intake and smoking in women attempting pregnancy through assisted reproductive technology (ART) or natural conception. Methods: Women attempting pregnancy through ART (n=1060) or natural conception (n=631) were selected during the periconception period. The intervention groups, conceived through ART or naturally, received Smarter Pregnancy coaching for 24 weeks, whereas the control group conceived through ART and did not receive coaching. Attitudes and practices at baseline and follow-up periods were obtained from self-administered online questionnaire provided by the program. Attitudes were assessed in women with unhealthy behaviors as their intention to increase their fruit and vegetable intake and to quit smoking using a yes/no question. Outcomes on practices, suggesting effectiveness, included daily fruit (pieces) and vegetable (grams) intake, and if women smoked (yes/no). Changes in attitudes and practices were compared at 12 and 24 weeks with baseline between the ART intervention and ART control groups, and within the intervention groups between ART and natural conception. Changes in practices at 12 and 24 weeks were also compared with baseline between women with negative attitude and positive attitude within the intervention groups: ART and natural conception. Analysis was performed using linear and logistic regression models adjusted for maternal confounders and baseline attitudes and practices. Results: The ART intervention group showed higher vegetable intake and lower odds for negative attitudes toward vegetable intake after 12 weeks (βadj=25.72 g, P<.001; adjusted odds ratio [ORadj] 0.24, P<.001) and 24 weeks of coaching (βadj=23.84 g, P<.001; ORadj 0.28, P<.001) compared with ART controls. No statistically significant effect was observed on attitudes and practices toward fruit intake (12 weeks: P=.16 and .08, respectively; 24 weeks: P=.16 and .08, respectively) and smoking behavior (12 weeks: P=.87; 24 weeks: P=.92). No difference was observed for the studied attitudes and practices between the ART intervention and natural conception intervention groups. Women with persistent negative attitude toward fruit and vegetable intake at week 12 showed lower fruit and vegetable intake at week 24 compared with women with positive attitude (βadj=–.49, P<.001; βadj=–30.07, P<.001, respectively). Conclusions: The eHealth Smarter Pregnancy program may improve vegetable intake–related attitudes and practices in women undergoing ART treatment. Women with no intention to increase fruit and vegetable intake had less improvement in their intakes. Despite small changes, this study demonstrates again that Smarter Pregnancy can be used to improve vegetable intake, which can complemented by blended care that combines face-to-face and online care to also improve fruit intake and smoking behavior. %M 36719733 %R 10.2196/39321 %U https://www.jmir.org/2023/1/e39321 %U https://doi.org/10.2196/39321 %U http://www.ncbi.nlm.nih.gov/pubmed/36719733 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e40373 %T Virtual Digital Psychotherapist App–Based Treatment in Patients With Methamphetamine Use Disorder (Echo-APP): Single-Arm Pilot Feasibility and Efficacy Study %A Chen,Tianzhen %A Chen,Liyu %A Li,Shuo %A Du,Jiang %A Su,Hang %A Jiang,Haifeng %A Wu,Qianying %A Zhang,Lei %A Bao,Jiayi %A Zhao,Min %+ Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 South Wan Ping Road, Shanghai, Shanghai, 200030, China, 86 2134773146, drminzhao@smhc.org.cn %K tablet %K Android program %K substance use disorder %K methamphetamine use disorder %K digital agent %K virtual digital human %D 2023 %7 31.1.2023 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Substance use disorder is one of the severe public health problems worldwide. Inequitable resources, discrimination, and physical distances limit patients’ access to medical help. Automated conversational agents have the potential to provide in-home and remote therapy. However, automatic dialogue agents mostly use text and other methods to interact, which affects the interaction experience, treatment immersion, and clinical efficacy. Objective: The aim of this paper is to describe the design and development of Echo-APP, a tablet-based app with the function of a virtual digital psychotherapist, and to conduct a pilot study to explore the feasibility and preliminary efficacy results of Echo-APP for patients with methamphetamine use disorder. Methods: Echo-APP is an assessment and rehabilitation program developed for substance use disorder (SUD) by a team of clinicians, psychotherapists, and computer experts. The program is available for Android tablets. In terms of assessment, the focus is on the core characteristics of SUD, such as mood, impulsivity, treatment motivation, and craving level. In terms of treatment, Echo-APP provides 10 treatment units, involving awareness of addiction, motivation enhancement, emotion regulation, meditation, etc. A total of 47 patients with methamphetamine dependence were eventually enrolled in the pilot study to receive a single session of the Echo-APP–based motivational enhancement treatment. The outcomes were assessed before and after the patients’ treatment, including treatment motivation, craving levels, self-perception on the importance of drug abstinence, and their confidence in stopping the drug use. Results: In the pilot study, scores on the Stages of Change Readiness and Treatment Eagerness Scale and the questionnaire on motivation for abstaining from drugs significantly increased after the Echo-APP–based treatment (P<.001, Cohen d=–0.60), while craving was reduced (P=.01, Cohen d=0.38). Patients’ baseline Generalized Anxiety Disorder-7 assessment score (β=3.57; P<.001; 95% CI 0.80, 2.89) and Barratt Impulsiveness Scale (BIS)–motor impulsiveness score (β=–2.10; P=.04; 95% CI –0.94, –0.02) were predictive of changes in the patients’ treatment motivation during treatment. Moreover, patients’ baseline Generalized Anxiety Disorder-7 assessment score (β=–1.607; P=.03; 95% CI –3.08, –0.14), BIS—attentional impulsivity score (β=–2.43; P=.004; 95% CI –4.03, –0.83), and BIS—nonplanning impulsivity score (β=2.54; P=.002; 95% CI 0.98, 4.10) were predictive of changes in craving scores during treatment. Conclusions: Echo-APP is a practical, accepted, and promising virtual digital psychotherapist program for patients with methamphetamine dependence. The preliminary findings lay a good foundation for further optimization of the program and the promotion of large-scale randomized controlled clinical studies for SUD. %M 36719727 %R 10.2196/40373 %U https://mhealth.jmir.org/2023/1/e40373 %U https://doi.org/10.2196/40373 %U http://www.ncbi.nlm.nih.gov/pubmed/36719727 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e41583 %T Developing a Technical-Oriented Taxonomy to Define Archetypes of Conversational Agents in Health Care: Literature Review and Cluster Analysis %A Denecke,Kerstin %A May,Richard %+ Bern University of Applied Sciences, Quellgasse 21, Biel, 2502, Switzerland, 41 32 321 67 94, kerstin.denecke@bfh.ch %K mobile phone %K user-computer interface %K telemedicine %K communication %K delivery of health care and methods %K delivery of health care and trends %D 2023 %7 30.1.2023 %9 Review %J J Med Internet Res %G English %X Background: The evolution of artificial intelligence and natural language processing generates new opportunities for conversational agents (CAs) that communicate and interact with individuals. In the health domain, CAs became popular as they allow for simulating the real-life experience in a health care setting, which is the conversation with a physician. However, it is still unclear which technical archetypes of health CAs can be distinguished. Such technical archetypes are required, among other things, for harmonizing evaluation metrics or describing the landscape of health CAs. Objective: The objective of this work was to develop a technical-oriented taxonomy for health CAs and characterize archetypes of health CAs based on their technical characteristics. Methods: We developed a taxonomy of technical characteristics for health CAs based on scientific literature and empirical data and by applying a taxonomy development framework. To demonstrate the applicability of the taxonomy, we analyzed the landscape of health CAs of the last years based on a literature review. To form technical design archetypes of health CAs, we applied a k-means clustering method. Results: Our taxonomy comprises 18 unique dimensions corresponding to 4 perspectives of technical characteristics (setting, data processing, interaction, and agent appearance). Each dimension consists of 2 to 5 characteristics. The taxonomy was validated based on 173 unique health CAs that were identified out of 1671 initially retrieved publications. The 173 CAs were clustered into 4 distinctive archetypes: a text-based ad hoc supporter; a multilingual, hybrid ad hoc supporter; a hybrid, single-language temporary advisor; and, finally, an embodied temporary advisor, rule based with hybrid input and output options. Conclusions: From the cluster analysis, we learned that the time dimension is important from a technical perspective to distinguish health CA archetypes. Moreover, we were able to identify additional distinctive, dominant characteristics that are relevant when evaluating health-related CAs (eg, input and output options or the complexity of the CA personality). Our archetypes reflect the current landscape of health CAs, which is characterized by rule based, simple systems in terms of CA personality and interaction. With an increase in research interest in this field, we expect that more complex systems will arise. The archetype-building process should be repeated after some time to check whether new design archetypes emerge. %M 36716093 %R 10.2196/41583 %U https://www.jmir.org/2023/1/e41583 %U https://doi.org/10.2196/41583 %U http://www.ncbi.nlm.nih.gov/pubmed/36716093 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41170 %T A Text Messaging–Based Support Intervention to Enhance Pre-exposure Prophylaxis for HIV Prevention Adherence During Pregnancy and Breastfeeding: Protocol for a Randomized Controlled Trial %A Mogaka,Jerusha Nyabiage %A Otieno,Felix Abuna %A Akim,Eunita %A Beima-Sofie,Kristin %A Dettinger,Julia %A Gomez,Lauren %A Marwa,Mary %A Odhiambo,Ben %A Ngure,Kenneth %A Ronen,Keshet %A Sharma,Monisha %A John-Stewart,Grace %A Richardson,Barbra %A Stern,Joshua %A Unger,Jennifer %A Udren,Jenna %A Watoyi,Salphine %A Pintye,Jillian %A Kinuthia,John %+ School of Nursing, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, United States, 1 206 543 4278, jpintye@uw.edu %K pre-exposure prophylaxis %K text messaging %K text message %K mobile technology %K PrEP adherence %K adherence %K prevention %K pregnancy %K pregnant %K breastfeeding %K maternal %K randomized %K RCT %K peripartum %K patient-provider %K postpartum %K HIV prevention %K SMS %K HIV %K mHealth %K mobile health %D 2023 %7 30.1.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cisgender women in Kenya are at elevated risk of HIV acquisition during pregnancy and post partum. Acute HIV infection during pregnancy and breastfeeding accounts for approximately one-third of all vertical HIV transmissions. The World Health Organization recommends offering oral tenofovir-based pre-exposure prophylaxis (PrEP) to pregnant and postpartum women who are HIV negative but at substantial and ongoing risk for HIV acquisition. PrEP delivery for pregnant and postpartum women is expanding within routine maternal child health clinics in Kenya. However, approximately half of pregnant women discontinue PrEP within 30 days of initiation. Therefore, it is crucial to develop PrEP adherence strategies that enhance support for adherence when peripartum events and health issues pose challenges to sustaining PrEP adherence. Objective: We are conducting a randomized controlled trial to determine the effect of a bidirectional communication platform named Mobile Solutions for Women’s and Children’s Health (mWACh), which utilizes two-way SMS text messaging between patients and remote nurses to support PrEP adherence and address maternal health concerns in real time during the peripartum period. Methods: The mWACh-PrEP study is a randomized trial designed to support PrEP adherence during the peripartum period by comparing mWACh-PrEP to the standard of care (ie, in-clinic adherence counseling) among women who are HIV negative and initiating PrEP. Purposive sampling was used to select 5 facilities offering PrEP in antenatal clinics in Kisumu and Siaya Counties, and block randomization will be used to divide participants into groups. Participants in the intervention arm will receive a customized messaging curriculum via SMS text messages targeted toward their particular perinatal stage. The primary outcome, PrEP adherence at 6 months post partum, will be evaluated using a log-binomial regression model, adjusting for imbalanced baseline characteristics. Based on a previous study of directly observed dosing conditions, we will use a hair tenofovir concentration cutoff of 0.038 ng/mg (corresponding to 7 doses/week) as the primary adherence outcome measured at 6 months post partum (binary outcome). Qualitative interviews and cost-effective analyses will be conducted to understand the feasibility, acceptability, and economic impact of the intervention. Results: Enrollment began in March 2022 and is projected to continue until July 2023, with follow-up through March 2024. The study results are expected to be reported in 2025. Conclusions: This trial will provide insights into using mobile health to enhance PrEP adherence among pregnant and postpartum mothers. Additionally, the findings will have implications for the use of mobile health technology to improve adherence to other daily medications during the peripartum period. Trial Registration: ClinicalTrials.gov NCT04472884; https://clinicaltrials.gov/ct2/show/NCT04472884 International Registered Report Identifier (IRRID): DERR1-10.2196/41170 %M 36716092 %R 10.2196/41170 %U https://www.researchprotocols.org/2023/1/e41170 %U https://doi.org/10.2196/41170 %U http://www.ncbi.nlm.nih.gov/pubmed/36716092 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e41591 %T The Current Knowledge, Attitudes, and Practices of the Neglected Methodology of Web-Based Questionnaires Among Chinese Health Workers: Web-Based Questionnaire Study %A Fang,Heping %A Lv,Yuxin %A Chen,Lin %A Zhang,Xuan %A Hu,Yan %+ Department of Child Health Care, Children's Hospital of Chongqing Medical University, Chongqing Key Laboratory of Pediatrics, Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Research Center for Child Health and Disorders, 136 Zhongshan 2nd Road, Yuzhong District, Chongqing, 400014, China, 86 02363622764, hy420@126.com %K epidemiological survey %K knowledge, attitudes, and practices (KAP) %K medical education %K methodology %K web-based questionnaire (WBQ) %D 2023 %7 27.1.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based questionnaire (WBQ) surveys are popular, but the quality of reporting WBQ survey research is uneven and unsatisfactory worldwide. Education and training on WBQ methodology may be necessary. However, the current knowledge, attitudes, and practices (KAP) of its methodology remain unknown. Objective: We investigated the KAP of WBQ methodology among Chinese health workers for the first time to clarify the possible reasons for the unsatisfactory reporting quality of WBQ survey research from China’s experience, aiming to provide a basis for improvement. Methods: We developed a structured WBQ based on the current recommendations and knowledge and investigated 458 health workers from June 7 to July 6, 2022. A total of 381 valid questionnaires were analyzed after data processing. We defined 50% and 75% as “qualified” and “satisfactory” in knowledge and practice topics to describe the results and analyzed the basic characteristics of the participants who had difficulties in conducting WBQ survey research. Results: A total of 215 (56.4%) participants had used WBQs for investigation, mostly more than 2 times (88.3%), but only 95 (44.2%) of them had ever received methodological training. A total of 134 (62.3%) users believed that WBQs were practical, but 126 (58.6%) had doubts about the reliability of the results. Most of the knowledge and practice topics did not reach a satisfactory level, and some even did not reach a qualified level. A total of 95 (44.2%)-136 (63.3%) of the users had reported difficulties in conducting WBQ survey research, and different participants could have different difficulties according to their characteristics. In addition, 191 (88.8%) users believed training was necessary. Conclusions: We found that Chinese health workers seriously underestimated and neglected the importance of the WBQ methodology, which may be an important reason for the reduced reporting quality of WBQ survey research. Medical educators need to strengthen methodological training on WBQs, which may help to improve the quality of WBQ survey research. %M 36533302 %R 10.2196/41591 %U https://www.jmir.org/2023/1/e41591 %U https://doi.org/10.2196/41591 %U http://www.ncbi.nlm.nih.gov/pubmed/36533302 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 9 %N %P e35116 %T Impacts of GlobalConsent, a Web-Based Social Norms Edutainment Program, on Sexually Violent Behavior and Bystander Behavior Among University Men in Vietnam: Randomized Controlled Trial %A Yount,Kathryn M %A Cheong,Yuk Fai %A Bergenfeld,Irina %A Trang,Quach Thu %A Sales,Jessica M %A Li,Yiman %A Minh,Tran Hung %+ Rollins School of Public Health, Emory University, 1518 Clifton Rd NE, Atlanta, GA, 30322, United States, 1 4047278511, kyount@emory.edu %K behavior change communication %K bystander behavior %K campus sexual assault %K educational entertainment (edutainment) %K sexual violence %K social cognitive theory %K social norms theory %K Vietnam %K mobile phone %D 2023 %7 27.1.2023 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: Sexual violence against women is prevalent worldwide. Prevention programs that treat men as allies and integrate a bystander framework are emerging in lower income settings, but evidence of their effectiveness is conflicting. Objective: This study aimed to test the impact of GlobalConsent on sexually violent behavior and prosocial bystander behavior among university men in Vietnam. Methods: We used a double-blind, parallel intervention versus control group design with 1:1 randomization at 2 universities. A total of 793 consenting heterosexual or bisexual men aged 18-24 years who matriculated in September 2019 were enrolled and assigned randomly to GlobalConsent or an attention-control adolescent health education (AHEAD) program. GlobalConsent is an adapted, theory-based, 6-module web-based intervention with diverse behavior change techniques and a locally produced serial drama. AHEAD is a customized, 6-module attention-control program on adolescent health. Both the programs were delivered to computers and smartphones over 12 weeks. Self-reported sexually violent behaviors toward women in the prior 6 months and prosocial bystander behaviors in the prior year were measured at 0, 6, and 12 months. Results: More than 92.7% (735/793) of men in both study arms completed at least 1 program module, and >90.2% (715/793) of men completed all 6 modules. At baseline, a notable percentage of men reported any sexually violent behavior (GlobalConsent: 123/396, 31.1%; AHEAD: 103/397, 25.9%) in the prior 6 months. Among men receiving GlobalConsent, the odds of reporting a high level (at least 2 acts) of sexually violent behavior at the endline were 1.3 times the odds at baseline. Among men receiving AHEAD, the corresponding odds ratio was higher at 2.7. The odds of reporting any bystander behavior at endline were 0.7 times the odds at baseline for GlobalConsent, and the corresponding odds ratio for AHEAD was lower at 0.5. Conclusions: Compared with a health attention-control condition, GlobalConsent has sustained favorable impacts on sexually violent behavior and prosocial bystander behavior among matriculating university men in Vietnam, who would otherwise face increasing risks of sexually violent behavior. GlobalConsent shows promise for national scale-up and regional adaptations. Trial Registration: ClinicalTrials.gov NCT04147455; https://clinicaltrials.gov/ct2/show/NCT04147455 International Registered Report Identifier (IRRID): RR2-10.1186/s12889-020-09454-2 %M 36705965 %R 10.2196/35116 %U https://publichealth.jmir.org/2023/1/e35116 %U https://doi.org/10.2196/35116 %U http://www.ncbi.nlm.nih.gov/pubmed/36705965 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e42172 %T Digital Intervention in Loneliness in Older Adults: Qualitative Analysis of User Studies %A Stuart,Avelie %A Yan,Ronnie Jieru %A Harkin,Lydia Jo %A Katz,Dmitri %A Stevenson,Clifford %A Mehta,Vikram %A Giles,Emilie %A Talbot,Catherine %A Gooch,Daniel %A Bennasar,Mohamed %A Self,Tara %A Nuseibeh,Bashar %A Price,Blaine %+ Computing and Communications, The Open University, Walton Hall, Milton Keynes, MK7 6AA, United Kingdom, 44 1908653545, blaine.price@open.ac.uk %K loneliness %K older adults %K digital connections %K reflection %K social identity %K user-centered design %K social network %K well-being apps %D 2023 %7 27.1.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Loneliness is a significant well-being issue that affects older adults. Existing, commonly used social connection platforms do not contain facilities to break the cognitive cycle of loneliness, and loneliness interventions implemented without due processes could have detrimental effects on well-being. There is also a lack of digital technology designed with older adults. Objective: We aimed to iteratively design a user-centered smartphone app that can address loneliness in older adults. The aim of this study was to investigate the loneliness-related psychological processes that our conceptual smartphone app promotes. We also identified the emergent needs and concerns that older adults raised regarding the potential benefits and detriments of the app. Methods: We used technology probes to elicit older adults’ reflections on the concept of using the app in 2 studies as follows: concept focus groups (n=33) and concept interviews (n=10). We then conducted a prototype trial with 1 week of use and follow-up interviews (n=12). Results: Thematic analysis explored the experiences and emergent challenges of our app through the design process. This led to the development of 4 themes as follows occurring in all 3 qualitative data sets: reflection on a digital social map is reassuring; app features encourage socializing; the risk of compounding loneliness; and individuals feel more control with mutual, socially beneficial activities. Conclusions: Smartphone apps have the potential to increase older adults’ awareness of the richness of their social connections, which may support loneliness reduction. Our qualitative approach to app design enabled the inclusion of older adults’ experiences in technology design. Thus, we conclude that the older adults in our study most desired functionalities that can support mutual activities and maintain or find new connections rather than enable them to share an emotional state. They were wary of the app replacing their preferred in-person social interaction. Participants also raised concerns about making the user aware of the lack of support in their social network and wanted specific means of addressing their needs. Further user-centered design work could identify how the app can support mutual activities and socializing. %M 36705962 %R 10.2196/42172 %U https://formative.jmir.org/2023/1/e42172 %U https://doi.org/10.2196/42172 %U http://www.ncbi.nlm.nih.gov/pubmed/36705962 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e40594 %T A Serious Game for Patients With Eating Disorders (Maze Out): Pilot User Experience and Acceptance Study %A Guala,Maria Mercedes %A Bul,Kim %A Skårderud,Finn %A Søgaard Nielsen,Anette %+ Psychiatric Research Unit, Institute of Clinical Research, University of Southern Denmark, J.B. Winsløws vej 18, Odense, 5000, Denmark, 45 65503671, mguala@health.sdu.dk %K eating disorders %K serious games %K mHealth %K coproduction %K mobile health %K mobile phone %D 2023 %7 27.1.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Eating disorders (EDs) are severe mental disorders associated with notable impairments in the quality of life. Despite the severity of the disorders and extensive research in the field, effective treatment for EDs is lacking. Digital interventions are gaining an evidence-based position in mental health, providing new perspectives in psychiatric treatment. Maze Out is a serious game coproduced by patients and therapists that focuses on supporting patients with EDs. Objective: The aim of this study was to investigate the experiences of engaging in and acceptability of Maze Out among patients with EDs and therapists. Methods: This study is a qualitative pilot study involving data collected through focus groups and individual interviews and user analytics collected through the game. The participants were recruited from the Odense Mental Health Service of the Region of Southern Denmark. Qualitative interviews analyzed by thematical analysis and interpreted by interpretative phenomenological analysis were used to evaluate the acceptance and experience of Maze Out among patients and therapists. The mobile health evidence reporting and assessment checklist was used to describe the content, context, and technical features of the game in a standardized manner for mobile health apps. Results: The participants found Maze Out to be engaging, easy to use, and a good platform for reflecting on their disorder. They primarily used Maze Out as a conversational tool with their close relationships, giving them insights into the experiences and daily life struggles of someone with EDs. Conclusions: Maze Out seems to be a promising tool supplementing the current ED treatment. Further research should focus on evaluating the effectiveness of the game and its potential to support patients with different types of EDs. %M 36705956 %R 10.2196/40594 %U https://formative.jmir.org/2023/1/e40594 %U https://doi.org/10.2196/40594 %U http://www.ncbi.nlm.nih.gov/pubmed/36705956 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e40188 %T Ultra-brief Assessment of Working Memory Capacity: Ambulatory Assessment Study Using Smartphones %A Hakun,Jonathan G %A Roque,Nelson A %A Gerver,Courtney R %A Cerino,Eric S %+ Department of Neurology, The Pennsylvania State University, College of Medicine, 500 University Drive, Hershey, PA, 17033, United States, 1 717 531 0003 ext 287082, jgh5196@psu.edu %K ecological momentary assessment %K EMA %K mobile cognitive assessment %K working memory capacity %K measurement burst design %K mobile phone %D 2023 %7 27.1.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The development of mobile technology with substantial computing power (ie, smartphones) has enabled the adaptation of performance-based cognitive assessments to remote administration and novel intensive longitudinal study designs (eg, measurement burst designs). Although an “ambulatory” cognitive assessment paradigm may provide new research opportunities, the adaptation of conventional measures to a mobile format conducive to intensive repeated measurement involves balancing measurement precision, administration time, and procedural consistency. Objective: Across 3 studies, we adapted “complex span” tests of working memory capacity (WMC) for ultra-brief, smartphone-based administration and examined their reliability, sufficiency, and associations with full-length, laboratory-based computerized administrations. Methods: In a laboratory-based setting, study 1 examined associations between ultra-brief smartphone adaptations of the operation span, symmetry span, and rotation span tasks and full-length computerized versions. In study 2, we conducted a 4-day ecological momentary assessment (EMA) study (4 assessments per day), where we examined the reliability of ultra-brief, ambulatory administrations of each task. In study 3, we conducted a 7-day EMA study (5 assessments per day) involving the ultra-brief rotation span task, where we examined reliability in the absence of extensive onboarding and training. Results: Measurement models in study 1 suggest that comparable estimates of latent WMC can be recovered from ultra-brief complex span task performance on smartphones. Significant correlations between the ultra-brief tasks and respective full-length versions were observed in study 1 and 2, ranging from r=0.4 to r=0.57. Results of study 2 and study 3 suggest that reliable between-person estimates of operation span, symmetry span, rotation span, and latent WMC can be obtained in 2-3 ultra-brief administrations (equivalent to <1 day of testing in an EMA study design). The results of study 3 replicated our findings, showing that reliable between-person estimates of rotation span may be obtained in as few as 2 ultra-brief administrations in the absence of extensive onboarding and training. In addition, the modification of task parameterization for study 3 improved the estimates of reliability of within-person change. Conclusions: Ultra-brief administration of complex span tasks on smartphones in a measurement burst design can generate highly reliable cross-sectional estimates of WMC. Considerations for future mobile cognitive assessment designs and parameterizations are discussed. %M 36705953 %R 10.2196/40188 %U https://formative.jmir.org/2023/1/e40188 %U https://doi.org/10.2196/40188 %U http://www.ncbi.nlm.nih.gov/pubmed/36705953 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e38877 %T A Novel Approach to Assess Weekly Self-efficacy for Meeting Personalized Physical Activity Goals Via a Cellphone: 12-Week Longitudinal Study %A Oh,Yoo Jung %A Hoffmann,Thomas J %A Fukuoka,Yoshimi %+ Department of Communication, University of California, Davis, 469 Kerr Hall, Davis, CA, 95616, United States, 1 530 760 5509, yjeoh@ucdavis.edu %K self-efficacy %K physical activity %K exercise %K cellphone %K mobile phone %K application %K app %K Ecological Momentary Assessment %D 2023 %7 27.1.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Despite the health benefits of engaging in regular physical activity (PA), the majority of American adults do not meet the PA guidelines for aerobic and muscle-strengthening activities. Self-efficacy, the belief that one can execute specific actions, has been suggested to be a strong determinant of PA behaviors. With the increasing availability of digital technologies, collecting longitudinal real-time self-efficacy and PA data has become feasible. However, evidence in longitudinal real-time assessment of self-efficacy in relation to objectively measured PA is scarce. Objective: This study aimed to examine a novel approach to measure individuals' real-time weekly self-efficacy in response to their personalized PA goals and performance over the 12-week intervention period in community-dwelling women who were not meeting PA guidelines. Methods: In this secondary data analysis, 140 women who received a 12-week PA intervention were asked to report their real-time weekly self-efficacy via a study mobile app. PA (daily step counts) was measured by an accelerometer every day for 12 weeks. Participants rated their self-efficacy on meeting PA goals (ranging from “not confident” to “very confident”) at the end of each week via a mobile app. We used a logistic mixed model to examine the association between weekly self-efficacy and weekly step goal success, controlling for age, BMI, self-reported White race, having a college education or higher, being married, and being employed. Results: The mean age was 52.7 (SD 11.5, range 25-68) years. Descriptive analyses showed the dynamics of real-time weekly self-efficacy on meeting PA goals and weekly step goal success. The majority (74.4%) of participants reported being confident in the first week, whereas less than half of them (46.4%) reported confidence in the final week of the intervention. Participants who met weekly step goals were 4.41 times more likely to be confident about achieving the following week's step goals than those who did not meet weekly step goals (adjusted odds ratio 4.41; 95% CI 2.59-7.50; P<.001). Additional analysis revealed that participants who were confident about meeting the following week’s step goals were 2.07 times more likely to meet their weekly step goals in the following week (adjusted odds ratio 2.07; 95% CI 1.16-3.70; P=.01). The significant bidirectional association between real-time self-efficacy and weekly step goal success was confirmed in a series of sensitivity analyses. Conclusions: This study demonstrates the potential utility of a novel approach to examine self-efficacy in real time for analysis of self-efficacy in conjunction with objectively measured PA. Discovering the dynamic patterns and changes in weekly self-efficacy on meeting PA goals may aid in designing a personalized PA intervention. Evaluation of this novel approach in an RCT is warranted. %M 36705945 %R 10.2196/38877 %U https://formative.jmir.org/2023/1/e38877 %U https://doi.org/10.2196/38877 %U http://www.ncbi.nlm.nih.gov/pubmed/36705945 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e37293 %T A Mobile Health App (ChillTime) Promoting Emotion Regulation in Dual Disorders: Acceptability and Feasibility Pilot Study %A Pennou,Antoine %A Lecomte,Tania %A Potvin,Stéphane %A Riopel,Gabrielle %A Vézina,Camille %A Villeneuve,Marie %A Abdel-Baki,Amal %A Khazaal,Yasser %+ Département de Psychologie, Université de Montréal, 90 Avenue Vincent d’Indy, Bur. C-358, Pavillon Marie-Victorin, succ Centre-Ville, post office box 6128, Montreal, QC, H2C 3J7, Canada, 1 514 343 6274, tania.lecomte@umontreal.ca %K dual disorder %K concomitant disorder %K mental disorder %K mental illness %K satisfaction %K mobile app %K mHealth %K mobile health %K emotion regulation %K distress management %K substance use disorder %K substance use %K emotion %K distress %K mental health %K acceptability %K feasibility %K psychosis %K psychotic %K schizophrenia %K emotional health %K pilot study %D 2023 %7 27.1.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: A growing number of studies highlight the importance of emotion regulation in the treatment and recovery of individuals with psychosis and concomitant disorders such as substance use disorder (SUD), for whom access to integrated dual-disorder treatments is particularly difficult. In this context, dedicated smartphone apps may be useful tools to provide immediate support to individuals in need. However, few studies to date have focused on the development and assessment of apps aimed at promoting emotional regulation for people with psychosis. Objective: The aim of this study was to evaluate the feasibility, acceptability, and potential clinical impact of a dedicated app (ChillTime) for individuals with psychotic disorders and concurrent SUD. The app design process followed recommendations for reducing cognitive effort on a mobile app. A total of 20 coping strategies regrouped in four categories (behavioral, emotional, cognitive, spiritual) were included in the app. Methods: This open pilot study followed a pre-post design. After the initial assessment, researchers asked participants to use the app as part of their treatment over a 30-day period. Feasibility was determined by the frequency of use of the app and measured using the number of completed strategies. Acceptability was determined by measuring ease of use, ease of learning, satisfaction, and perceived utility at the end of the 30-day study period based on responses to satisfaction questionnaires. Clinical scales measuring emotion regulation, substance use (ie, type of substance, amount taken, and frequency of use), and various psychiatric symptoms were administered at the beginning and end of the 30-day period. Results: A total of 13 participants were recruited from two first-episode psychosis clinics in Montreal, Quebec, Canada. All participants were symptomatically stable, were between 18 and 35 years of age (mostly men; 70% of the sample), and had a schizophrenia spectrum disorder with a comorbid substance use diagnosis. A total of 11 participants completed the study (attrition<20%). Approximately half of the participants used the tool at least 33% of the days (11-21 days). Cognitive and emotion-focused techniques were rated the highest in terms of usefulness and were the most frequently used. The majority of participants gave positive answers about the ease of use and the ease of learning the tool. A nonsignificant association of ChillTime use with negative symptoms and drug use was observed. No other statistically significant changes were observed. Conclusions: The ChillTime app showed good feasibility (approximately half of the participants used the tool at least 33% of the days) and acceptability among people with schizophrenia spectrum disorder and SUD. Trends suggesting a potential impact on certain clinical outcomes will need to be replicated in larger-sample studies before any conclusion can be drawn. %M 36705963 %R 10.2196/37293 %U https://formative.jmir.org/2023/1/e37293 %U https://doi.org/10.2196/37293 %U http://www.ncbi.nlm.nih.gov/pubmed/36705963 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e42956 %T Supporting Youth Vaping Cessation With the Crush the Crave Smartphone App: Protocol for a Randomized Controlled Trial %A Sanchez,Sherald %A Deck,Alicia %A Baskerville,Neill Bruce %A Chaiton,Michael %+ Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Ursula Franklin St, Toronto, ON, M5S 2S1, Canada, 1 416 435 8501, Michael.Chaiton@camh.ca %K e-cigarettes %K vaping cessation %K youth and young adult health %K adult %K youth %K effectiveness %K smartphone %K application %K vaping %K cessation %K assessment %K intervention %D 2023 %7 27.1.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: The use of e-cigarettes, or vaping, has increased exponentially in the past decade, particularly among youth. Emerging evidence indicates growing nicotine dependence among youth, revealing historically higher rates of dependence among current e-cigarette users compared to rates seen in earlier research. Despite the urgent need for youth vaping cessation interventions, there is limited knowledge about the process of vaping cessation, and few evidence-based interventions are available to young people seeking support. A notable literature review on vaping cessation resources for young people recommended technology-based interventions, such as smartphone apps and SMS text messaging services, as a promising area of vaping cessation research and intervention development. Objective: The primary aim of our study is to determine the effectiveness of the Crush the Crave app in supporting vaping cessation among youth recruited to the intervention arm via comparison with an assessment-only control group. The primary hypothesis is that participants in the intervention group—those using Crush the Crave—will be more likely to be abstinent at the 6-month follow-up point than participants in the assessment-only control arm. Methods: A 2-arm, single-blind, parallel randomized controlled trial will be conducted over 12 months. Study invitations will be sent to 600 youth (age: 16-18 years) and young adult (age: 19-29 years) e-cigarette users and randomized between an intervention arm, which will be using Crush the Crave (n=300), and an assessment-only control arm (n=300) in a 1:1 ratio. The primary hypothesis is that participants in the intervention group—those using Crush the Crave—will be more likely to be abstinent at the 6-month follow-up point. Results: Study recruitment began on March 4, 2022. Recruitment is anticipated to be completed in December 2022. Conclusions: This protocol describes one of the first-ever randomized controlled trial studies to evaluate the effectiveness of an app-based intervention for supporting vaping cessation among youth aged 16 to 18 years and young adults aged 19 to 29 years. The findings from our trial will help increase our understanding of the process of vaping cessation among youth and provide evidence on the effectiveness of an app-based intervention in helping young people quit vaping. The trial results will also have implications in the development of current and future approaches to youth vaping cessation. Trial Registration: OSF Registries osf.io/hmd87; https://doi.org/10.17605/OSF.IO/HMD87 International Registered Report Identifier (IRRID): DERR1-10.2196/42956 %M 36705967 %R 10.2196/42956 %U https://www.researchprotocols.org/2023/1/e42956 %U https://doi.org/10.2196/42956 %U http://www.ncbi.nlm.nih.gov/pubmed/36705967 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 0 %N %P e0 %T Improvements in Glycemic Control and Depressive Symptoms Among Adults With Type 2 Diabetes: Retrospective Study %A Venkatesan,Aarathi %A Zimmermann,Gretchen %A Rawlings,Kelly %A Ryan,Claudia %A Voelker,Louise %A Edwards,Caitlyn %+ Vida Health, 100 Montgomery St #750, San Francisco, CA, 94104, United States, 1 (415) 989 1017, caitlyn.edwards@vida.com %K type 2 diabetes %K digital health %K diabetes intervention %K diabetes %K diabetic %K health app %K coaching %K patient education %K mobile health %K mHealth %K app-based %K health coaching %K hemoglobin A1c %K HbA1c %K depression %K depressive %K anxiety %K mental health %K glycemic control %K diabetes management %K health management %K digital health intervention %D 2023 %7 13.1.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The prevalence of diabetes remains high, with traditional lifestyle interventions demonstrating limited success in improving diabetes-related outcomes, particularly among individuals with diabetes-related mental health comorbidities. Digital health interventions provide the ability to ease the sustained and rigorous self-management needs associated with diabetes care and treatment. Current interventions though, are plagued by small sample sizes, underpowered pilot studies, and immense heterogeneity in program intervention, duration, and measured outcomes. Objective: Therefore, this work aimed to evaluate the effectiveness of a mobile health diabetes management program on measures of glycemic control in a high-risk population with type 2 diabetes (hemoglobin A1c [HbA1c] ≥8.0%), utilizing a sample of 1128 participants who provided baseline and follow-up data. The sustainability of this change in glycemic control was examined in a subset of participants (n=455) at 6 months and 1 year following program enrollment. A secondary analysis examined changes in glycemic control among a subset of participants with self-reported mild-to-moderate depression at baseline. Methods: This study utilized a single-arm, retrospective design. Participants were enrolled in the Vida Health Diabetes Management Program. This app-based intervention utilized one-on-one remote sessions with a health coach, registered dietitian nutritionist, and/or a certified diabetes care and education specialist and structured lessons and tools related to diabetes management and self-care. Participants provided baseline (–365 to 21 days of program enrollment) as well as follow-up (at least 90 days following program enrollment) HbA1c values. Paired t tests were used to evaluate changes in HbA1c between baseline and follow-up time points. The 8-item Patient Health Questionnaire and the 7-item Generalized Anxiety Disorder Scale were utilized to assess self-reported depressive and anxiety symptoms, respectively. Paired t tests and linear regression modeling accounting for pertinent covariates were used to evaluate changes in mental health symptom acuity and their relationship with changes in glycemic control. Results: We observed a significant decrease in HbA1c of –1.35 points between baseline (mean 9.84, SD 1.64) and follow-up (mean 8.48, SD 1.77; t=22.56, P<.001) among this large, high-risk sample. This decrease was sustained up to 1 year following program enrollment. Additionally, a significant relationship between improvements in depressive symptom acuity and improvements in HbA1c was observed (β=–0.74, P=.03). Conclusions: This study demonstrates clinically meaningful improvements in glycemic control among participants enrolled in the Vida Health Diabetes Management Program. Additionally, this work presents one of the largest studied samples of participants enrolled in a digital health diabetes management program to date. %R 10.2196/41880 %U https://formative.jmir.org/2023/0/e0/ %U https://doi.org/10.2196/41880 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e40529 %T Effects of Wearable Fitness Trackers and Activity Adequacy Mindsets on Affect, Behavior, and Health: Longitudinal Randomized Controlled Trial %A Zahrt,Octavia Hedwig %A Evans,Kristopher %A Murnane,Elizabeth %A Santoro,Erik %A Baiocchi,Michael %A Landay,James %A Delp,Scott %A Crum,Alia %+ Department of Psychology, Stanford University, Building 420, 450 Jane Stanford Way, Stanford, CA, 94305, United States, 1 970 987 9182, crum@stanford.edu %K physical activity %K health technology %K psychology %K mindset %K mobile health %K mHealth %K activity trackers %K fitness trackers %K activity monitors %K wearables %K health behavior %K digital health %K health promotion %K intervention %K mobile phone %D 2023 %7 25.1.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: There is some initial evidence suggesting that mindsets about the adequacy and health consequences of one’s physical activity (activity adequacy mindsets [AAMs]) can shape physical activity behavior, health, and well-being. However, it is unknown how to leverage these mindsets using wearable technology and other interventions. Objective: This research examined how wearable fitness trackers and meta-mindset interventions influence AAMs, affect, behavior, and health. Methods: A total of 162 community-dwelling adults were recruited via flyers and web-based platforms (ie, Craigslist and Nextdoor; final sample size after attrition or exclusion of 45 participants). Participants received an Apple Watch (Apple Inc) to wear for 5 weeks, which was equipped with an app that recorded step count and could display a (potentially manipulated) step count on the watch face. After a baseline week of receiving no feedback about step count, participants were randomly assigned to 1 of 4 experimental groups: they received either accurate step count (reference group; 41/162, 25.3%), 40% deflated step count (40/162, 24.7%), 40% inflated step count (40/162, 24.7%), or accurate step count+a web-based meta-mindset intervention teaching participants the value of adopting more positive AAMs (41/162, 25.3%). Participants were blinded to the condition. Outcome measures were taken in the laboratory by an experimenter at the beginning and end of participation and via web-based surveys in between. Longitudinal analysis examined changes within the accurate step count condition from baseline to treatment and compared them with changes in the deflated step count, inflated step count, and meta-mindset conditions. Results: Participants receiving accurate step counts perceived their activity as more adequate and healthier, adopted a healthier diet, and experienced improved mental health (Patient-Reported Outcomes Measurement Information System [PROMIS]-29) and aerobic capacity but also reduced functional health (PROMIS-29; compared with their no-step-count baseline). Participants exposed to deflated step counts perceived their activity as more inadequate; ate more unhealthily; and experienced more negative affect, reduced self-esteem and mental health, and increased blood pressure and heart rate (compared with participants receiving accurate step counts). Inflated step counts did not change AAM or most other outcomes (compared with accurate step counts). Participants receiving the meta-mindset intervention experienced improved AAM, affect, functional health, and self-reported physical activity (compared with participants receiving accurate step counts only). Actual step count did not change in either condition. Conclusions: AAMs––induced by trackers or adopted deliberately––can influence affect, behavior, and health independently of actual physical activity. Trial Registration: ClinicalTrials.gov NCT03939572; https://www.clinicaltrials.gov/ct2/show/NCT03939572 %M 36696172 %R 10.2196/40529 %U https://www.jmir.org/2023/1/e40529 %U https://doi.org/10.2196/40529 %U http://www.ncbi.nlm.nih.gov/pubmed/36696172 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e34474 %T Automatic Depression Detection Using Smartphone-Based Text-Dependent Speech Signals: Deep Convolutional Neural Network Approach %A Kim,Ah Young %A Jang,Eun Hye %A Lee,Seung-Hwan %A Choi,Kwang-Yeon %A Park,Jeon Gue %A Shin,Hyun-Chool %+ Department of Electronics Engineering, Soongsil University, 511 Sang-do dong, Seoul, 156743, Republic of Korea, 82 28287165, shinhc@ssu.ac.kr %K depression %K major depressive disorder %K MDD %K automatic depression detection %K ADD %K mobile health %K deep learning %K speech analysis %K acoustic %K mobile phone %K smartphone %D 2023 %7 25.1.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Automatic diagnosis of depression based on speech can complement mental health treatment methods in the future. Previous studies have reported that acoustic properties can be used to identify depression. However, few studies have attempted a large-scale differential diagnosis of patients with depressive disorders using acoustic characteristics of non-English speakers. Objective: This study proposes a framework for automatic depression detection using large-scale acoustic characteristics based on the Korean language. Methods: We recruited 153 patients who met the criteria for major depressive disorder and 165 healthy controls without current or past mental illness. Participants' voices were recorded on a smartphone while performing the task of reading predefined text-based sentences. Three approaches were evaluated and compared to detect depression using data sets with text-dependent read speech tasks: conventional machine learning models based on acoustic features, a proposed model that trains and classifies log-Mel spectrograms by applying a deep convolutional neural network (CNN) with a relatively small number of parameters, and models that train and classify log-Mel spectrograms by applying well-known pretrained networks. Results: The acoustic characteristics of the predefined text-based sentence reading automatically detected depression using the proposed CNN model. The highest accuracy achieved with the proposed CNN on the speech data was 78.14%. Our results show that the deep-learned acoustic characteristics lead to better performance than those obtained using the conventional approach and pretrained models. Conclusions: Checking the mood of patients with major depressive disorder and detecting the consistency of objective descriptions are very important research topics. This study suggests that the analysis of speech data recorded while reading text-dependent sentences could help predict depression status automatically by capturing the characteristics of depression. Our method is smartphone based, is easily accessible, and can contribute to the automatic identification of depressive states. %M 36696160 %R 10.2196/34474 %U https://www.jmir.org/2023/1/e34474 %U https://doi.org/10.2196/34474 %U http://www.ncbi.nlm.nih.gov/pubmed/36696160 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e42394 %T Adding Mobile Elements to Online Physical Activity Interventions for Adults Aged Over 50 Years: Prototype Development Study %A Collombon,Eline H G M %A Peels,Denise A %A Bolman,Catherine A W %A de Bruijn,Gert-Jan %A Lechner,Lilian %+ Faculty of Psychology, Open Universiteit, Valkenburgerweg 177, Heerlen, 6419 AT, Netherlands, 31 455762888, Eline.Collombon@ou.nl %K prototype %K pilot test %K eHealth %K mHealth %K physical activity %K older adults %K development %K usability %D 2023 %7 25.1.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Only a minority of adults aged over 50 years meet physical activity (PA) guidelines of the World Health Organization (WHO). eHealth interventions are proven effective tools to help this population increase its PA levels in the short term, among which the Active Plus and I Move interventions have been developed by our own research group. To achieve long-term effects, increase intervention use, and decrease dropout rates, 3 emergent but different mobile elements (an activity tracker, an ecological momentary intervention [EMI] program, and a chatbot) were added separately to Active Plus and I Move. In this study, the prototype development and pilot-testing of these interventions is described. Objective: This study aims to enhance 2 existing PA-stimulating computer-based interventions with 3 mobile elements (an activity tracker, an EMI program, or a chatbot) and test the prototypes on usability and appreciation within a target population of adults aged over 50 years. Methods: A systematic design protocol consisting of development, evaluation, and adaptation procedures was followed with involvement of the target population. Literature searches separated per mobile element and interviews with the target population (N=11) led to 6 prototypes: Active Plus or I Move including (1) an activity tracker, (2) EMI, or (3) a chatbot. These prototypes were tested on usability and appreciation during pilot tests (N=47) and subsequently fine-tuned based on the results. Results: The literature searches and interviews provided important recommendations on the preferences of the target population, which enabled us to develop prototypes. The subsequent pilot tests showed that the mobile elements scored moderate to good on usability, with average System Usability Scale (SUS) scores of 52.2-82.2, and moderate to good on enjoyment and satisfaction, with average scores ranging from 5.1 to 8.1 on a scale of 1-10. The activity tracker received the best scores, followed by EMI, followed by the chatbot. Based on the findings, the activity tracker interventions were fine-tuned and technical difficulties regarding EMI and the chatbot were solved, which is expected to further improve usability and appreciation. Conclusions: During this study, 6 prototypes of online PA interventions with added mobile elements were developed and tested for usability and appreciation. Although all prototypes scored moderate to high on usability, enjoyment, and satisfaction, it can be concluded that the integration of an activity tracker with a computer-based PA intervention is the most promising option among the 3 mobile elements tested during this study. The prototype development steps of the systematic design protocol followed can be considered useful and successful for the purposes of this study. The interventions can now be evaluated on a larger scale through a randomized controlled trial. International Registered Report Identifier (IRRID): RR2-10.2196/31677 %M 36696157 %R 10.2196/42394 %U https://formative.jmir.org/2023/1/e42394 %U https://doi.org/10.2196/42394 %U http://www.ncbi.nlm.nih.gov/pubmed/36696157 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e34989 %T Relationship Between Valence and Arousal for Subjective Experience in a Real-life Setting for Supportive Housing Residents: Results From an Ecological Momentary Assessment Study %A Nandy,Rajesh %A Nandy,Karabi %A Walters,Scott T %+ Department of Biostatistics and Epidemiology, School of Public Health, University of North Texas Health Science Center, 3500 Camp Bowie Blvd, Fort Worth, TX, 76107, United States, 1 2063296441, Rajesh.Nandy@unthsc.edu %K permanent supportive housing %K circumplex model of affect %K ecological momentary assessment %K emotion %K valence %K arousal %K mobile phone %D 2023 %7 25.1.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The circumplex model of affect posits that valence and arousal are the principal dimensions of affect. The center of the 2D space represents a neutral state of valence and a medium state of arousal. The role of valence and arousal in human emotion has been studied extensively. However, no consistent relationship between valence and arousal has been established. Most of the prior studies investigating the relationship have been conducted in relatively controlled laboratory settings. Objective: Ecological momentary assessment (EMA) of affect from participants residing in permanent supportive housing was used to study the relationship between valence and arousal in real-life settings. The goal of this study was to explore the relationship between valence and arousal in a person’s natural environment. Methods: Participants were recruited from housing agencies in Fort Worth, Texas, United States. All participants had a history of chronic homelessness and reported at least one mental health condition. A subset of participants completed daily (morning) EMAs of emotions and other behaviors. The sample comprised 78 women and 77 men, and the average age was 52 (SD 8) years. From the circumplex model of affect, the EMA included 9 questions related to the participant’s current emotional state (happy, frustrated, sad, worried, restless, excited, calm, bored, and sluggish). The responses were used to calculate 2 composite scores for valence and arousal. Results: Statistical models uniformly showed a dominant linear relation between valence and arousal and a significant difference in the slopes among races. None of the other effects were statistically significant. Compared with previous studies, the effects were quite robust. Conclusions: Our findings may provide a window to the fundamental structure of affect. We found a strong positive linear relationship between valence and arousal at the nomothetic level, which may provide insight into a universal structure of affect. However, the study needs to be replicated for different populations to determine whether our findings can be generalized beyond the population studied here. %M 36696164 %R 10.2196/34989 %U https://formative.jmir.org/2023/1/e34989 %U https://doi.org/10.2196/34989 %U http://www.ncbi.nlm.nih.gov/pubmed/36696164 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e38535 %T Web-based Guidance for Assisted Reproductive Technology With an Online App (myFertiCare): Quantitative Evaluation With the HOT-fit Framework %A Sparidaens,Ellen Marie %A Logger,Jade G M %A Nelen,Willianne L D M %A Braat,Didi D M %A Fleischer,Kathrin %A Hermens,Rosella P M %+ Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, PO Box 9101, Nijmegen, 6500HB, Netherlands, 31 0243617351, ellenmarie.sparidaens@radboudumc.nl %K eHealth %K personalized %K interactive %K evaluation %K HOT-fit framework %K assisted reproductive technologies %K reproductive %K technology %K online %K app %K application %K tool %K internet %K usability %K infertility %K variables %K treatment %K women %K care %K stress %D 2023 %7 24.1.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Assisted reproductive technologies (ARTs) are considered to be physically and mentally stressful. During their treatment trajectory, couples express high information and communication needs. They appreciate using the internet to obtain fertility-related information. In a previous study, we developed myFertiCare, an eHealth tool providing personalized information and interactive functionalities for infertile couples in order to improve patient-centered care. The app has already been successful in qualitative evaluations of usability. Objective: The aim of the current study is to quantitatively evaluate the implementation of myFertiCare by using the human, organizational, and technology–fit (HOT-fit) framework and to study the effects of using myFertiCare on couples’ knowledge about infertility, their experience of the burden of infertility, and their experience of patient-centered care. With these results, implementation can be further improved, and patient-centered care can be enhanced. Methods: A quantitative study was performed based on the HOT-fit framework using validated questionnaires focusing on the human, organizational, and technology domains. Questions were added on the effect of using myFertiCare on couples’ knowledge about infertility and treatment. Questions regarding the burden of infertility, the burden of infertility treatment, and the experience of patient-centeredness were based on the main items of the validated fertility quality of life (FertiQoL) and Patient-Centredness Questionnaire–Infertility questionnaires, respectively. Also, nonusers of the app were included to explore motivations for not using the app and identify opportunities for improvement. Finally, user data were analyzed to provide insight into multiple variables concerning app use. Results: In the human and technology domains, myFertiCare showed good system usability, high user satisfaction, and high information and interface quality. In the organizational domain, implementation was considered to be sufficient by both patients and staff. Use of the app increased knowledge about the treatment, improved coping with the treatment, and enhanced the experience of patient-centeredness. User data showed that women were the main app users and that use of the app gradually declined during the treatment trajectory. Conclusions: A multi-faceted online app, myFertiCare, has been successfully evaluated quantitatively for implementation by using the HOT-fit framework. Use of the app increased knowledge about the treatment, improved coping with the treatment, and enhanced the experience of patient-centeredness. App use could be improved by creating more publicity. By providing myFertiCare, professionals in fertility care are supported in guiding patients through their treatment trajectory and in delivering patient-centered care. %M 36692928 %R 10.2196/38535 %U https://www.jmir.org/2023/1/e38535 %U https://doi.org/10.2196/38535 %U http://www.ncbi.nlm.nih.gov/pubmed/36692928 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e37289 %T Analyzing User-Generated Web-Based Posts of Adolescents’ Emotional, Behavioral, and Symptom Responses to Beliefs About Depression: Qualitative Thematic Analysis %A Dysthe,Kim Kristoffer %A Røssberg,Jan Ivar %A Brandtzaeg,Petter Bae %A Skjuve,Marita %A Haavet,Ole Rikard %A Følstad,Asbjørn %A Klovning,Atle %+ Department of General Practice/Family Medicine, University of Oslo, Kirkeveien 166, Oslo, 0450, Norway, 47 47 22 85 05 50, k.k.dysthe@medisin.uio.no %K adolescent %K depression %K internet %K education %K preventive psychiatry %K early medical intervention %K health literacy %K cognitive behavioral therapy %D 2023 %7 24.1.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression is common during adolescence. Early intervention can prevent it from developing into more progressive mental disorders. Combining information technology and clinical psychoeducation is a promising way to intervene at an earlier stage. However, data-driven research on the cognitive response to health information targeting adolescents with symptoms of depression is lacking. Objective: This study aimed to fill this knowledge gap through a new understanding of adolescents’ cognitive response to health information about depression. This knowledge can help to develop population-specific information technology, such as chatbots, in addition to clinical therapeutic tools for use in general practice. Methods: The data set consists of 1870 depression-related questions posted by adolescents on a public web-based information service. Most of the posts contain descriptions of events that lead to depression. On a sample of 100 posts, we conducted a qualitative thematic analysis based on cognitive behavioral theory investigating behavioral, emotional, and symptom responses to beliefs associated with depression. Results: Results were organized into four themes. (1) Hopelessness, appearing as a set of negative beliefs about the future, possibly results from erroneous beliefs about the causal link between risk factors and the course of depression. We found beliefs about establishing a sturdy therapy alliance as a responsibility resting on the patient. (2) Therapy hesitancy seemed to be associated with negative beliefs about therapy prognosis and doubts about confidentiality. (3) Social shame appeared as a consequence of impaired daily function when the cause is not acknowledged. (4) Failing to attain social interaction appeared to be associated with a negative symptom response. In contrast, actively obtaining social support reduces symptoms and suicidal thoughts. Conclusions: These results could be used to meet the clinical aims stated by earlier psychoeducation development, such as instilling hope through direct reattribution of beliefs about the future; challenging causal attributions, thereby lowering therapy hesitancy; reducing shame through the mechanisms of externalization by providing a tentative diagnosis despite the risk of stigmatizing; and providing initial symptom relief by giving advice on how to open up and reveal themselves to friends and family and balance the message of self-management to fit coping capabilities. An active counseling style advises the patient to approach the social environment, demonstrating an attitude toward self-action. %M 36692944 %R 10.2196/37289 %U https://www.jmir.org/2023/1/e37289 %U https://doi.org/10.2196/37289 %U http://www.ncbi.nlm.nih.gov/pubmed/36692944 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e42866 %T The Feasibility of Implementing Remote Measurement Technologies in Psychological Treatment for Depression: Mixed Methods Study on Engagement %A de Angel,Valeria %A Adeleye,Fadekemi %A Zhang,Yuezhou %A Cummins,Nicholas %A Munir,Sara %A Lewis,Serena %A Laporta Puyal,Estela %A Matcham,Faith %A Sun,Shaoxiong %A Folarin,Amos A %A Ranjan,Yatharth %A Conde,Pauline %A Rashid,Zulqarnain %A Dobson,Richard %A Hotopf,Matthew %+ Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, E3.08, 3rd Floor East Wing, de Crespigny park, London, SE5 8AF, United Kingdom, 44 20 7848 0002, valeria.de_angel@kcl.ac.uk %K depression %K anxiety %K digital health %K wearable devices %K smartphone %K passive sensing %K mobile health %K mHealth %K digital phenotyping %K mobile phone %D 2023 %7 24.1.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Remote measurement technologies (RMTs) such as smartphones and wearables can help improve treatment for depression by providing objective, continuous, and ecologically valid insights into mood and behavior. Engagement with RMTs is varied and highly context dependent; however, few studies have investigated their feasibility in the context of treatment. Objective: A mixed methods design was used to evaluate engagement with active and passive data collection via RMT in people with depression undergoing psychotherapy. We evaluated the effects of treatment on 2 different types of engagement: study attrition (engagement with study protocol) and patterns of missing data (engagement with digital devices), which we termed data availability. Qualitative interviews were conducted to help interpret the differences in engagement. Methods: A total of 66 people undergoing psychological therapy for depression were followed up for 7 months. Active data were gathered from weekly questionnaires and speech and cognitive tasks, and passive data were gathered from smartphone sensors and a Fitbit (Fitbit Inc) wearable device. Results: The overall retention rate was 60%. Higher-intensity treatment (χ21=4.6; P=.03) and higher baseline anxiety (t56.28=−2.80, 2-tailed; P=.007) were associated with attrition, but depression severity was not (t50.4=−0.18; P=.86). A trend toward significance was found for the association between longer treatments and increased attrition (U=339.5; P=.05). Data availability was higher for active data than for passive data initially but declined at a sharper rate (90%-30% drop in 7 months). As for passive data, wearable data availability fell from a maximum of 80% to 45% at 7 months but showed higher overall data availability than smartphone-based data, which remained stable at the range of 20%-40% throughout. Missing data were more prevalent among GPS location data, followed by among Bluetooth data, then among accelerometry data. As for active data, speech and cognitive tasks had lower completion rates than clinical questionnaires. The participants in treatment provided less Fitbit data but more active data than those on the waiting list. Conclusions: Different data streams showed varied patterns of missing data, despite being gathered from the same device. Longer and more complex treatments and clinical characteristics such as higher baseline anxiety may reduce long-term engagement with RMTs, and different devices may show opposite patterns of missingness during treatment. This has implications for the scalability and uptake of RMTs in health care settings, the generalizability and accuracy of the data collected by these methods, feature construction, and the appropriateness of RMT use in the long term. %M 36692937 %R 10.2196/42866 %U https://mental.jmir.org/2023/1/e42866 %U https://doi.org/10.2196/42866 %U http://www.ncbi.nlm.nih.gov/pubmed/36692937 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e37487 %T The Effectiveness of eHealth Interventions on Lifestyle Modification in Patients With Nonalcoholic Fatty Liver Disease: Systematic Review and Meta-analysis %A Kwon,Oh Young %A Choi,Jin-young %A Jang,Yeonsoo %+ College of Nursing and Mo-Im Kim Nursing Research Institute, Yonsei University, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea, 82 2 2228 3343, ysjang517@yuhs.ac %K eHealth %K lifestyle modification %K non-alcoholic fatty liver disease %K systematic review %K meta-analysis %D 2023 %7 23.1.2023 %9 Review %J J Med Internet Res %G English %X Background: The prevalence of nonalcoholic fatty liver disease (NAFLD) is increasing in parallel with the epidemic of obesity and metabolic syndrome. Lifestyle modification is a crucial strategy for the treatment of NAFLD, which can lead to a reduction in liver fat with concomitant weight loss. The use of eHealth technologies is an effective approach to improve health outcomes in patients as they do not have any time and space limitations. Objective: This study aimed to evaluate published eHealth intervention studies for the improvement of lifestyle modifications among patients with NAFLD and to provide recommendations for future studies. Methods: We conducted a systematic review and meta-analysis. Five electronic databases (PubMed, Cochrane Central, CINAHL, Embase, and Web of Science) were searched for studies reporting the effect of lifestyle modification intervention using eHealth in patients with NAFLD published from inception to November 3, 2022. Study selection, data extraction, and quality assessment were performed by 3 researchers independently. The quality of included studies was assessed using the Cochrane risk of bias tool and the Risk of Bias Assessment Tool for Nonrandomized Studies. Results: In total, 2688 records were identified, and 41 full-text articles were assessed. Seven studies were included in the systematic review. The participants of all interventions were 1257 individuals with NAFLD, and the mean age ranged from 38.3 to 57.9 years. The duration of the interventions was 3-24 months, and all interventions were categorized into 3 types: internet-based computers, telephones, and mobile apps. Of these, 4 studies were randomized controlled trials and were included in the meta-analysis: 3 studies for body weight and BMI and 4 studies for alanine aminotransferase (ALT) and aspartate aminotransferase (AST). According to the meta-analysis, clear improvements in BMI (P=.02; 95% CI –1.01 to –0.10), AST (P=.02; 95% CI –1.22 to –0.13), and ALT (P=.01; 95% CI –1.28 to –0.15) were observed in the eHealth intervention as compared with the control groups. Conclusions: Lifestyle modification interventions using eHealth technologies are significantly effective for BMI, AST, and ALT in patients with NAFLD. Future research should conduct interventions with larger sample sizes and evaluate whether these interventions have sustained benefits, and how we can make these eHealth methods most effective on a large scale. %M 36689264 %R 10.2196/37487 %U https://www.jmir.org/2023/1/e37487 %U https://doi.org/10.2196/37487 %U http://www.ncbi.nlm.nih.gov/pubmed/36689264 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e42178 %T The Acceptability of Technology-Based Physical Activity Interventions in Postbariatric Surgery Women: Insights From Qualitative Analysis Using the Unified Theory of Acceptance and Use of Technology 2 Model %A Thérouanne,Pierre %A Hayotte,Meggy %A Halgand,Florent %A d'Arripe-Longueville,Fabienne %+ Université Côte d'Azur, LAPCOS, Laboratoire d'Anthropologie et de Psychologie Cliniques, Cognitives et Sociales Campus Saint Jean d'Angely / SJA3 / MSHS Sud-Est, 25 avenue François Mitterrand, Nice, 06300, France, 33 4 89 15 23 49, pierre.therouanne@univ-cotedazur.fr %K acceptability %K health technology %K physical activity %K obesity %K UTAUT2 %D 2023 %7 23.1.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Bariatric surgery offers an opportunity for physical activity (PA) promotion due to patients’ increased ability to engage in PA. Technology-based PA interventions are promising tools for promoting PA to support patients in this key period. The Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) model is a recognized theoretical model for examining technology acceptability. Although a previous study reported that 92% of women with obesity have high acceptability of at least one technology-based PA intervention, little is known about the factors that lead to different levels of acceptability between technologies and therefore the reasons for choosing a preferred intervention. Objective: The purpose of this study was to (1) characterize the acceptability of 3 technology-based PA interventions (ie, telehealth, active video game, mobile app) in the context of bariatric surgery, and (2) explore patients’ preference motives. This study, using a qualitative design, examined the suitability of the UTAUT2 model in this specific context. Methods: Participants (n=26) read written French descriptions of the technology-based PA interventions with illustrations and chose their preferred intervention. Semidirective interviews were conducted to explore the reasons for their choice of the preferred intervention, notably using the UTAUT2 framework. Data were analyzed based on inductive and deductive approaches. Results: All participants who preferred a technology-based PA intervention (ie, active video game, n=10; mobile app, n=10; telehealth, n=6) expressed a behavioral intention to use it. In addition, some of them expressed a high behavioral intention to use another technology (ie, active video game, n=4; mobile app, n=1; telehealth, n=7). All the constructs of the UTAUT2 emerged during the qualitative interviews and were specified through subcategories. Additional constructs also emerged, especially other motivational factors. Conclusions: This study showed that, in the context of technology-based PA interventions for postbariatric patients, the UTAUT2 is suitable, although additional motivational factors (which were not considered by the UTAUT2 model) should be considered. %M 36689255 %R 10.2196/42178 %U https://humanfactors.jmir.org/2023/1/e42178 %U https://doi.org/10.2196/42178 %U http://www.ncbi.nlm.nih.gov/pubmed/36689255 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e43629 %T Can a Single Variable Predict Early Dropout From Digital Health Interventions? Comparison of Predictive Models From Two Large Randomized Trials %A Bricker,Jonathan %A Miao,Zhen %A Mull,Kristin %A Santiago-Torres,Margarita %A Vock,David M %+ Division of Public Health Sciences, Fred Hutch Cancer Center, 1100 Fairview Avenue North, M3-B232, Seattle, WA, 98109, United States, 1 2066675000, jbricker@fredhutch.org %K acceptance and commitment therapy %K ACT %K attrition %K digital interventions %K dropout %K eHealth %K engagement %K iCanQuit %K mobile health %K mHealth %K QuitGuide %K smartphone apps %K smoking %K tobacco %K trajectories %K mobile phone %D 2023 %7 20.1.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: A single generalizable metric that accurately predicts early dropout from digital health interventions has the potential to readily inform intervention targets and treatment augmentations that could boost retention and intervention outcomes. We recently identified a type of early dropout from digital health interventions for smoking cessation, specifically, users who logged in during the first week of the intervention and had little to no activity thereafter. These users also had a substantially lower smoking cessation rate with our iCanQuit smoking cessation app compared with users who used the app for longer periods. Objective: This study aimed to explore whether log-in count data, using standard statistical methods, can precisely predict whether an individual will become an iCanQuit early dropout while validating the approach using other statistical methods and randomized trial data from 3 other digital interventions for smoking cessation (combined randomized N=4529). Methods: Standard logistic regression models were used to predict early dropouts for individuals receiving the iCanQuit smoking cessation intervention app, the National Cancer Institute QuitGuide smoking cessation intervention app, the WebQuit.org smoking cessation intervention website, and the Smokefree.gov smoking cessation intervention website. The main predictors were the number of times a participant logged in per day during the first 7 days following randomization. The area under the curve (AUC) assessed the performance of the logistic regression models, which were compared with decision trees, support vector machine, and neural network models. We also examined whether 13 baseline variables that included a variety of demographics (eg, race and ethnicity, gender, and age) and smoking characteristics (eg, use of e-cigarettes and confidence in being smoke free) might improve this prediction. Results: The AUC for each logistic regression model using only the first 7 days of log-in count variables was 0.94 (95% CI 0.90-0.97) for iCanQuit, 0.88 (95% CI 0.83-0.93) for QuitGuide, 0.85 (95% CI 0.80-0.88) for WebQuit.org, and 0.60 (95% CI 0.54-0.66) for Smokefree.gov. Replacing logistic regression models with more complex decision trees, support vector machines, or neural network models did not significantly increase the AUC, nor did including additional baseline variables as predictors. The sensitivity and specificity were generally good, and they were excellent for iCanQuit (ie, 0.91 and 0.85, respectively, at the 0.5 classification threshold). Conclusions: Logistic regression models using only the first 7 days of log-in count data were generally good at predicting early dropouts. These models performed well when using simple, automated, and readily available log-in count data, whereas including self-reported baseline variables did not improve the prediction. The results will inform the early identification of people at risk of early dropout from digital health interventions with the goal of intervening further by providing them with augmented treatments to increase their retention and, ultimately, their intervention outcomes. %M 36662550 %R 10.2196/43629 %U https://www.jmir.org/2023/1/e43629 %U https://doi.org/10.2196/43629 %U http://www.ncbi.nlm.nih.gov/pubmed/36662550 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e36922 %T Web-Based Interventions for Pregnant Women With Gestational Diabetes Mellitus: Systematic Review and Meta-analysis %A Guo,Pingping %A Chen,Dandan %A Xu,Ping %A Wang,Xiaojuan %A Zhang,Wei %A Mao,Minna %A Zheng,Qiong %A Jin,Ying %A Feng,Suwen %+ Women’s Hospital, Zhejiang University School of Medicine, No.1 Xue Shi Road, Hangzhou, Zhejiang Province, 310003, China, 86 139 5716 8708, fengsw@zju.edu.cn %K gestational diabetes mellitus %K internet %K intervention %K meta-analysis %K pregnant women %K systematic review %K mobile phone %D 2023 %7 19.1.2023 %9 Review %J J Med Internet Res %G English %X Background: Effective management of gestational diabetes mellitus (GDM) is essential because it is one of the most prevalent diseases during pregnancy, and the consequent condition maternal hyperglycemia is closely related to considerable short- and long-term maternal and neonatal complications. Web-based interventions (WBIs), defined as therapeutic interventions offered via the web, have been implemented to assist in managing GDM owing to their advantages of high accessibility and efficiency, but findings across relevant studies are inconsistent. Objective: This systematic review and meta-analysis aimed to evaluate the effectiveness of WBIs on glycemic control among pregnant women with GDM; examine whether specific types of intervention interactivity, format, and technology have beneficial effects on maternal glycemic control; and comprehensively assess the efficacy of WBIs in maternal behavioral outcomes, cognitive and attitudinal outcomes, mental health, maternal and neonatal clinical outcomes, and medical service use and costs among pregnant women with GDM. Methods: PubMed, Embase, Cochrane Library, Web of Science, CINAHL, and PsycINFO were searched from their respective inception to November 19, 2022, to identify relevant randomized controlled trials and controlled clinical trials. The methodological quality of the included studies was assessed using the Effective Public Health Practice Project tool. Where possible, the data for all outcomes were meta-analyzed using the Stata software (version 12.0; StataCorp). Overall, 3 subgroup analyses and post hoc sensitivity analyses of maternal glycemic control parameters were performed. Results: Overall, 25 publications arising from 21 randomized controlled trials and controlled clinical trials were included. The overall meta-analyses on glycemic control parameters demonstrated that WBIs could significantly improve fasting blood glucose (standardized mean difference=−1.764, 95% CI −2.972 to −0.557; P=.004) and 2-hour postprandial blood glucose (standardized mean difference=−1.433, 95% CI −2.561 to −0.304; P=.01) compared with the control group, whereas no significant effect was found on glycated hemoglobin and 1-hour postprandial blood glucose. The results of the subgroup analyses indicated that mobile app–delivered interventions with a personalized format and interactive function showed more beneficial effects on maternal glycemic control. Moreover, WBIs could significantly enhance compliance with the self-monitoring of blood glucose; increase the rate of normal vaginal delivery; and decrease the chance of emergency cesarean, admission to the neonatal intensive care unit, and composite neonatal complications. GDM knowledge, risk perception of the disease, self-efficacy, satisfaction with care, and medical service use of the participants in the WBI group were also improved compared with the control group. However, the effectiveness of WBIs on other secondary outcomes was either nonsignificant or uncertain. Conclusions: WBIs are a promising approach to GDM management. Personalized, interactive, and mobile app–delivered interventions seem more worthy of being recommended for future clinical practice. Further high-quality studies are required to verify these findings before making broad recommendations. Trial Registration: PROSPERO CRD42022296625; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=296625 %M 36656629 %R 10.2196/36922 %U https://www.jmir.org/2023/1/e36922 %U https://doi.org/10.2196/36922 %U http://www.ncbi.nlm.nih.gov/pubmed/36656629 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e38597 %T The Effectiveness of Internet-Based Cognitive Behavioral Therapy as a Preventive Intervention in the Workplace to Improve Work Engagement and Psychological Outcomes: Protocol for a Systematic Review and Meta-analysis %A Luangphituck,Wasana %A Boonyamalik,Plernpit %A Klainin-Yobas,Piyanee %+ Department of Public Health Nursing, Faculty of Public Health, Mahidol University, 420/1 Rajvithi Road, Rajthavi, Bangkok, 10400, Thailand, 66 2 354 8542 ext 3403, plernpit.suw@mahidol.ac.th %K systematic review %K internet-based %K cognitive behavioral therapy %K work engagement %K psychological outcomes %K employees %K workplace %K web-based %K occupational health %K mental health %K stress %K depression %K anxiety %K eHealth %K digital health %D 2023 %7 19.1.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Mental health has become an increasingly significant issue in the workplace. Non–health care workers are experiencing increased levels of psychological symptoms in their workplaces, especially during the COVID-19 pandemic, which limited social interactions and health service access. These conditions have a negative effect on employees’ mental health and may also be associated with work-related outcomes, such as reduced levels of work engagement. Cognitive behavioral therapy (CBT) is one of the most effective methods used for treating workers with mental illness and preventing work-related psychological outcomes. The delivery of internet-based CBT (iCBT) has been established as a result of both technological improvements that have influenced health promotion and prevention components, and limited social contact and health service access. Objective: The purpose of this systematic review is to synthesize the best available evidence concerning the preventive effect of iCBT on employees. Methods: A systematic search will be conducted across 12 electronic databases, including a hand search for main journals and reference lists. Randomized controlled trials testing the effects of iCBT on psychological outcomes and work engagement among employees will be eligible. Initial keywords will cover the concepts of employees, workers, non–health care personnel, internet-based, web-based, eHealth cognitive behavioral interventions, stress, depression, anxiety, and work engagement, and then a full search strategy will be developed. Following titles, abstracts and the full text will be screened for assessment against the inclusion criteria for the review. Search results will be fully reported and presented per Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Two independent reviewers will screen and extract data, appraise methodological quality using the Cochrane risk-of-bias assessment tool, and assess overall quality of evidence with the Grading of Recommendations Assessment, Development, and Evaluation approach. A random effects meta-analysis and standardized mean differences using review manager software will be applied to synthesize the effect of iCBT based on similar outcomes. Results: This protocol was registered in the International Prospective Register of Systematic Reviews in March 2022 and is now an ongoing process. The data will be analyzed in August 2022, and the review process should be completed by December 2022. All included studies will be synthesized and presented to demonstrate the effectiveness of iCBT in decreasing psychological distress and optimizing work engagement outcomes among employees. Conclusions: According to the findings of this study, iCBT therapies will be used to promote mental health concerns such as depressive symptoms, anxiety, psychological distress, stress, insomnia, and resilience among non–health care professionals. In addition, the results will be used to ensure the policy related to reducing psychological distress and optimizing work engagement in the workplace. International Registered Report Identifier (IRRID): PRR1-10.2196/38597 %M 36656635 %R 10.2196/38597 %U https://www.researchprotocols.org/2023/1/e38597 %U https://doi.org/10.2196/38597 %U http://www.ncbi.nlm.nih.gov/pubmed/36656635 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e40725 %T Web-Based Asynchronous Tool to Facilitate Communication Between Primary Care Providers and Cancer Specialists: Pragmatic Randomized Controlled Trial %A Petrovic,Bojana %A Julian,Jim A %A Liddy,Clare %A Afkham,Amir %A McGee,Sharon F %A Morgan,Scott C %A Segal,Roanne %A Sussman,Jonathan %A Pond,Gregory R %A O'Brien,Mary Ann %A Bender,Jacqueline L %A Grunfeld,Eva %+ Department of Family and Community Medicine, University of Toronto, 500 University Ave, 5th floor, Toronto, ON, M5G 1V7, Canada, 1 416 978 7518, bojana.petrovic@utoronto.ca %K electronic communication %K coordination of care %K cancer %K primary care %D 2023 %7 18.1.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Cancer poses a significant global health burden. With advances in screening and treatment, there are now a growing number of cancer survivors with complex needs, requiring the involvement of multiple health care providers. Previous studies have identified problems related to communication and care coordination between primary care providers (PCPs) and cancer specialists. Objective: This study aimed to examine whether a web- and text-based asynchronous system (eOncoNote) could facilitate communication between PCPs and cancer specialists (oncologists and oncology nurses) to improve patient-reported continuity of care among patients receiving treatment or posttreatment survivorship care. Methods: In this pragmatic randomized controlled trial, a total of 173 patients were randomly assigned to either the intervention group (eOncoNote plus usual methods of communication between PCPs and cancer specialists) or a control group (usual communication only), including 104 (60.1%) patients in the survivorship phase (breast and colorectal cancer) and 69 (39.9%) patients in the treatment phase (breast and prostate cancer). The primary outcome was patient-reported team and cross-boundary continuity (Nijmegen Continuity Questionnaire). Secondary outcome measures included the Generalized Anxiety Disorder Screener (GAD-7), Patient Health Questionnaire on Major Depression, and Picker Patient Experience Questionnaire. Patients completed the questionnaires at baseline and at 2 points following randomization. Patients in the treatment phase completed follow-up questionnaires at 1 month and at either 4 months (patients with prostate cancer) or 6 months following randomization (patients with breast cancer). Patients in the survivorship phase completed follow-up questionnaires at 6 months and at 12 months following randomization. Results: The results did not show an intervention effect on the primary outcome of team and cross-boundary continuity of care or on the secondary outcomes of depression and patient experience with their health care. However, there was an intervention effect on anxiety. In the treatment phase, there was a statistically significant difference in the change score from baseline to the 1-month follow-up for GAD-7 (mean difference −2.3; P=.03). In the survivorship phase, there was a statistically significant difference in the change score for GAD-7 between baseline and the 6-month follow-up (mean difference −1.7; P=.03) and between baseline and the 12-month follow-up (mean difference −2.4; P=.004). Conclusions: PCPs’ and cancer specialists’ access to eOncoNote is not significantly associated with patient-reported continuity of care. However, PCPs’ and cancer specialists’ access to the eOncoNote intervention may be a factor in reducing patient anxiety. Trial Registration: ClinicalTrials.gov NCT03333785; https://clinicaltrials.gov/ct2/show/NCT03333785 %M 36652284 %R 10.2196/40725 %U https://www.jmir.org/2023/1/e40725 %U https://doi.org/10.2196/40725 %U http://www.ncbi.nlm.nih.gov/pubmed/36652284 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e35669 %T Predictors of Adolescents’ Response to a Web-Based Intervention to Improve Psychosocial Adjustment to Having an Appearance-Affecting Condition (Young Person’s Face IT): Prospective Study %A Zelihić,Deniz %A Feragen,Kristin J Billaud %A Pripp,Are Hugo %A Nordgreen,Tine %A Williamson,Heidi %A Kling,Johanna %+ Centre for Rare Disorders, Rikshospitalet, Oslo University Hospital, Børrestuveien 3, Oslo, 0373, Norway, 47 23075340, denizz@student.sv.uio.no %K visible difference %K web-based interventions %K eHealth %K body esteem %K social anxiety %K adolescents %D 2023 %7 18.1.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Adolescents with a condition affecting their appearance that results in a visible difference can be at risk of psychosocial distress and impaired adjustment. Evidence for the effectiveness of existing interventions in improving psychosocial outcomes is limited, and relevant treatment can be difficult to access. Young Person’s Face IT (YPF), a self-guided web-based intervention, has demonstrated potential in reducing social anxiety in adolescents with a visible difference. However, more knowledge is needed about the variables that contribute to variations in intervention effects to identify those who may benefit most from YPF. Objective: This study aimed to investigate demographic, psychosocial, and intervention-related variables as predictors of overall intervention effects after adolescents’ use of YPF. Methods: We used longitudinal data collected as part of a larger, ongoing mixed methods project and randomized controlled trial (ClinicalTrials.gov NCT03165331) investigating the effectiveness of the Norwegian version of YPF. Participants were 71 adolescents (mean age 13.98, SD 1.74 years; range 11-18 years; 43/71, 61% girls) with a wide range of visible differences. The adolescents completed primary (body esteem and social anxiety symptoms) and secondary (perceived stigmatization, life disengagement, and self-rated health satisfaction) outcome measures at baseline and postintervention measurement. The predictor variables were demographic (age and gender), psychosocial (frequency of teasing experiences related to aspects of the body and appearance as well as depressive and anxiety symptoms), and intervention-related (time spent on YPF) variables. Results: Two-thirds (47/71, 66%) of the adolescents completed all YPF sessions and spent an average of 265 (SD 125) minutes on the intervention. Backward multiple regression analyses with a 2-tailed P-value threshold of .20 revealed that several variables were retained in the final models and predicted postintervention outcome changes. Body esteem was predicted by age (P=.14) and frequency of teasing experiences (P=.09). Social anxiety symptoms were predicted by gender (P=.12), frequency of teasing experiences (P=.03), depressive and anxiety symptoms (P=.08), and time spent on YPF (P=.06). Perceived stigmatization was predicted by age (P=.09), gender (P=.09), frequency of teasing experiences (P=.19), and depressive and anxiety symptoms (P=.06). Life disengagement was predicted by gender (P=.03), depressive and anxiety symptoms (P=.001), and time spent on YPF (P=.14). Self-rated health satisfaction was predicted by age (P=.008). However, the results were limited by relatively low explained postintervention variance, ranging from 1.6% to 24.1%. Conclusions: This study suggests that adolescent boys, adolescents who experience higher levels of psychosocial distress related to their visible difference, and adolescents who spend sufficient time on YPF may obtain better overall intervention effects. %M 36652281 %R 10.2196/35669 %U https://formative.jmir.org/2023/1/e35669 %U https://doi.org/10.2196/35669 %U http://www.ncbi.nlm.nih.gov/pubmed/36652281 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e41859 %T Evaluating the Effectiveness of the Supportive Parenting App on Parental Outcomes: Randomized Controlled Trial %A Shorey,Shefaly %A Law,Evelyn %A , %A Mathews,Jancy %A Lim,Siew Hoon %A Shi,Luming %A Chua,Jing Shi %A Du,Ruochen %A Chan,Yiong Huak %A Tan,Thiam Chye %A Chee,Cornelia %A Chong,Yap Seng %+ Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 2, Clinical Research Centre, Block MD11,10 Medical Drive, Singapore, Singapore 117597, Singapore, 65 66011294, nurssh@nus.edu.sg %K postnatal depression %K mobile health technology %K social support %K COVID-19 %K psychoeducation %K peer support %K mobile phone %D 2023 %7 16.1.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Adjusting to new or additional parenting responsibilities increases stress and affects parental well-being. Existing research has highlighted both parents’ desire to receive more support. It has also been found that receiving sufficient social support enhances parenting outcomes. With the increasing popularity of mobile health apps, a Supportive Parenting App (SPA) intervention was developed to fulfill the support needs of parents during the perinatal period. Objective: This study aimed to examine the effectiveness of the SPA on parental outcomes during the perinatal period. Methods: A 2-group pretest and repeated posttest randomized controlled trial was conducted wherein 200 couples (N=400 mothers and fathers) were recruited from 2 public health care institutions in Singapore. Parents were randomly assigned to intervention (100/200, 50%) or control (100/200, 50%) groups. The SPA intervention consisted of a mobile app–based psychoeducation and peer support program to support parents from pregnancy to 6 months post partum. The outcome measures included postnatal depression, anxiety, parental bonding, parental self-efficacy, perceived social support, and parenting satisfaction. Data were collected at baseline (at >24 weeks of gestation—age of viability in Singapore) and at the first, second, fourth, sixth, ninth, and 12th month post partum. Linear mixed models were used to compare parental outcomes between the groups, and a linear mixed model for repeated measures was used to examine within-group changes. Results: Parents in the intervention group mostly showed better outcomes compared with those in the control group. Parents in the intervention group had higher perceived social support than those in the control group at the first (effect size=1.59, 95% CI 0.38-2.80; Cohen standardized effect size=1.31; P=.01), second (effect size=1.98, 95% CI 1.09-2.88; Cohen standardized effect size=2.21; P=.003), and fourth (effect size=2.57, 95% CI 1.62-3.51; Cohen standardized effect size=2.72; P=.048) months post partum. However, parents in the intervention group showed significantly poorer parental bonding (effect size=1.67, 95% CI 0.24-3.11; Cohen standardized effect size=1.16; P=.02). The other parental outcomes did not differ significantly between groups. The scores of mothers and fathers also differed significantly for all outcomes except parental self-efficacy. Conclusions: Parents in the intervention group generally fared better, especially regarding perceived social support. However, the lack of statistical significance in most outcomes showed the limited effectiveness of the SPA intervention, which may be because of the COVID-19 pandemic. Parental differences in outcome scores suggest that mothers and fathers have different support needs; therefore, interventions should be tailored accordingly. Further improvements and evaluations are needed to examine the effectiveness of the SPA intervention in enhancing parental outcomes. Despite statistically insignificant results, limitations should be considered to further improve mobile health app–based interventions such as SPA, as they could serve as reliable and convenient sources of support for parents. Trial Registration: Clinicaltrails.gov NCT4706442; https://clinicaltrials.gov/ct2/show/NCT04706442 %M 36645699 %R 10.2196/41859 %U https://www.jmir.org/2023/1/e41859 %U https://doi.org/10.2196/41859 %U http://www.ncbi.nlm.nih.gov/pubmed/36645699 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 6 %N %P e39898 %T Feasibility, Safety, Enjoyment, and System Usability of Web-Based Aerobic Dance Exercise Program in Older Adults: Single-Arm Pilot Study %A Hyodo,Kazuki %A Kidokoro,Tetsuhiro %A Yamaguchi,Daisuke %A Iida,Michitaka %A Watanabe,Yuya %A Ueno,Aiko %A Noda,Takayuki %A Kawahara,Kenji %A Nishida,Sumiyo %A Kai,Yuko %A Arao,Takashi %+ Physical Fitness Research Institute, Meiji Yasuda Life Foundation of Health and Welfare, Tobuki 150, Hachioji, Tokyo, 192-0001, Japan, 81 42 691 1163, k-hyodo@my-zaidan.or.jp %K low-intensity exercise %K home exercise %K online exercise %K supervised exercise %K elderly %K COVID-19 %K smartphone %K tablet %K videoconferencing platform %D 2023 %7 16.1.2023 %9 Original Paper %J JMIR Aging %G English %X Background: During the COVID-19 epidemic, opportunities for social interaction and physical activity among older people are decreasing, which may have a negative impact on their health. As a solution, a web-based group exercise program provided through a videoconferencing platform would be useful. As a web-based exercise program that older adults can easily, safely, and enjoyably perform at home, we developed a short-duration, light-intensity aerobic dance exercise program. Before studying the effectiveness of this exercise program, its characteristics, such as feasibility, safety, enjoyment, and system usability, should be examined among older adults. Objective: This pilot study aimed to examine the feasibility, safety, and enjoyment of a web-based aerobic dance exercise program and the usability of a web-based exercise delivery system using a videoconferencing platform for older adults. Methods: This study was designed as a prospective single-arm pilot study. A total of 16 older adults participated in an 8-week web-based aerobic dance program held every morning (8:30 AM to 8:50 AM) on weekdays at home. Retention and adherence rates were measured for the program’s feasibility. Safety was assessed by the heart rate reserve, an index of exercise intensity calculated from heart rate, and the number of adverse events during exercise sessions. Enjoyment of this exercise program was assessed by an 11-point Likert scale ranging from 0 (not enjoyable at all) to 10 (extremely enjoyable) obtained through telephone interviews after the first-, third-, sixth-, and eighth-week intervention. For usability, the ease of the videoconferencing platform system was assessed through telephone interviews after the intervention. Results: A female participant with hypertension dropped out in the second week because of the continuously reported high blood pressure (≥180 mmHg) before attending the exercise session in the first week. Therefore, the retention rate was 93.8% (15/16). Among the remaining participants, the median (IQR) overall adherence rate was 97.4% (94.7-100). Regarding safety, the mean (SD) heart rate reserve during the aerobic dance exercise was 29.8% (6.8%), showing that the exercise was relatively safe with very light to light intensity. There were no adverse events during the exercise session. The enjoyment score (0-10 points) significantly increased from the first (6.7 [1.7]) to sixth (8.2 [1.3]) and eighth week (8.5 [1.3]). Regarding usability, 11 participants reported difficulties at the beginning, such as basic touch panel operations and the use of unfamiliar applications; however, all got accustomed to it and subsequently reported no difficulty. Conclusions: This study showed high feasibility, enjoyment, and safety of the web-based aerobic dance exercise program in older adults, and the web-based exercise delivery system may have areas for improvement, albeit without serious problems. Our web-based aerobic dance exercise program may contribute to an increase in physical and social activities among older adults. %M 36645705 %R 10.2196/39898 %U https://aging.jmir.org/2023/1/e39898 %U https://doi.org/10.2196/39898 %U http://www.ncbi.nlm.nih.gov/pubmed/36645705 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e40121 %T Internet-Based Self-Assessment for Symptoms of Internet Use Disorder—Impact of Gender, Social Aspects, and Symptom Severity: German Cross-sectional Study %A Dieris-Hirche,Jan %A Bottel,Laura %A Herpertz,Stephan %A Timmesfeld,Nina %A te Wildt,Bert Theodor %A Wölfling,Klaus %A Henningsen,Peter %A Neumann,Anja %A Beckers,Rainer %A Pape,Magdalena %+ Department of Psychosomatic Medicine and Psychotherapy, LWL-University Hospital, Ruhr University Bochum, Alexandrinenstr. 1-3, Bochum, 44791, Germany, 49 234 5077 3135, jan.dieris-hirche@rub.de %K internet use disorder %K eHealth %K telemedicine %K internet addiction %K gaming disorder %K OMPRIS %K internet use %K online self-assessment %K self-assessment %K eHealth services %D 2023 %7 12.1.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet use disorder (IUD) is a new type of behavioral addiction in the digital age. At the same time, internet applications and eHealth can also provide useful support in medical treatment. Objective: The purpose of this study is to examine if an internet-based eHealth service can reach individuals with IUD. In particular, it should be investigated whether both male and female individuals with more severe IUDs can be reached. Methods: Data were retrieved from the OMPRIS (online-based motivational intervention to reduce problematic internet use and promote treatment motivation in internet gaming disorder and internet use disorder) project (DRKS00019925), an internet-based motivational intervention to reduce problematic internet use and promote treatment motivation in internet gaming disorder and IUD. During the recruitment process (August 2020-March 2022), a total of 3007 individuals filled out the standardized scale for the assessment of internet and computer game addiction (AICA-S). The assessment was accessible via the project homepage. There was no preselection of participants at this stage of the study; however, the offer was addressed to people with hazardous internet use and IUDs. The web-based assessment was free and could be found via search engines, but attention was also drawn to the service via newspaper articles, radio reports, and podcasts. Results: Out of 3007 who participated in the web-based self-assessment, 1033 (34.4%) are female, 1740 (57.9%) are male, 67 (2.2%) are diverse individuals, and 167 (5.5%) did not disclose their gender. The IUD symptom severity score showed a wide range between the AICA-S extreme values of 0 and 27 points. On average, the total sample (mean 8.19, SD 5.47) was in the range of hazardous IUD behavior (AICA-S cutoff>7.0). Furthermore, 561 individuals (18.7% of the total sample; mean 17.42, SD 3.38) presented severe IUD (AICA-S cutoff>13.5). Focusing on female and male participants, 20.9% (363/1740) of the men and 14.9% (151/1033) of the women scored above 13.5 points, which can be considered pathological IUD behavior (χ22,2773=16.73, P<.001, effect size: Cramér V=0.078). Unemployment, being in vocational training or studying at a university, and being male were significantly associated with high IUD symptoms. Conclusions: Using a large sample, the study showed that both mildly and severely IUD-affected individuals can be reached via the internet. An internet-based eHealth offer can thus be a good way to reach patients with IUD where they are addicted—on the internet. In addition, eHealth services increase the likelihood of reaching female patients, who hardly ever come to specialized outpatient clinics and hospitals. Since social problems, especially unemployment, have a strong association with disease severity, the integration of social counseling into treatment seems advisable in terms of a multidisciplinary approach. Trial Registration: German Clinical Trials Register (DRKS) DRKS00019925; https://drks.de/search/de/trial/DRKS00019925 %M 36633897 %R 10.2196/40121 %U https://www.jmir.org/2023/1/e40121 %U https://doi.org/10.2196/40121 %U http://www.ncbi.nlm.nih.gov/pubmed/36633897 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e40017 %T A Digital Lifestyle Coach (E-Supporter 1.0) to Support People With Type 2 Diabetes: Participatory Development Study %A Hietbrink,Eclaire A G %A Middelweerd,Anouk %A van Empelen,Pepijn %A Preuhs,Katharina %A Konijnendijk,Annemieke A J %A Oude Nijeweme-d’Hollosy,Wendy %A Schrijver,Laura K %A Laverman,Gozewijn D %A Vollenbroek-Hutten,Miriam M R %+ Department of Biomedical Signals and Systems, University of Twente, Drienerlolaan 5, Enschede, 7500 AE Enschede, Netherlands, 31 53 4892760, e.a.g.hietbrink@utwente.nl %K eHealth %K mHealth %K diet %K nutrition %K physical activity %K lifestyle change %K coaching %K dynamic tailoring %K behavior change %K blended care %K type 2 diabetes %K design %K treatment %K chronic disease %K behavioral %K theory %K intervention %K acceptability %K usability %K cost %D 2023 %7 12.1.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: A healthy lifestyle, including regular physical activity and a healthy diet, is becoming increasingly important in the treatment of chronic diseases. eHealth interventions that incorporate behavior change techniques (BCTs) and dynamic tailoring strategies could effectively support a healthy lifestyle. E-Supporter 1.0 is an eCoach designed to support physical activity and a healthy diet in people with type 2 diabetes (T2D). Objective: This paper aimed to describe the systematic development of E-Supporter 1.0. Methods: Our systematic design process consisted of 3 phases. The definition phase included the selection of the target group and formulation of intervention objectives, and the identification of behavioral determinants based on which BCTs were selected to apply in the intervention. In the development phase, intervention content was developed by specifying tailoring variables, intervention options, and decision rules. In the last phase, E-Supporter 1.0 integrated in the Diameter app was evaluated using a usability test in 9 people with T2D to assess intervention usage and acceptability. Results: The main intervention objectives were to stimulate light to moderate-vigorous physical activities or adherence to the Dutch dietary guidelines in people with T2D. The selection of behavioral determinants was informed by the health action process approach and theories explaining behavior maintenance. BCTs were included to address relevant behavioral determinants (eg, action control, self-efficacy, and coping planning). Development of the intervention resulted in 3 types of intervention options, consisting of motivational messages, behavioral feedback, and tailor-made supportive exercises. On the basis of IF-THEN rules, intervention options could be tailored to, among others, type of behavioral goal and (barriers to) goal achievement. Data on these variables could be collected using app data, activity tracker data, and daily ecological momentary assessments. Usability testing revealed that user experiences were predominantly positive, despite some problems in the fixed delivery of content. Conclusions: The systematic development approach resulted in a theory-based and dynamically tailored eCoach. Future work should focus on expanding intervention content to other chronic diseases and lifestyle behaviors, enhancing the degree of tailoring and evaluating intervention effects on acceptability, use, and cost-effectiveness. %M 36633898 %R 10.2196/40017 %U https://humanfactors.jmir.org/2023/1/e40017 %U https://doi.org/10.2196/40017 %U http://www.ncbi.nlm.nih.gov/pubmed/36633898 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e38333 %T Digital Health Interventions for Adult Patients With Cancer Evaluated in Randomized Controlled Trials: Scoping Review %A Lee,Kyunghwa %A Kim,Sanghee %A Kim,Soo Hyun %A Yoo,Sung-Hee %A Sung,Ji Hyun %A Oh,Eui Geum %A Kim,Nawon %A Lee,Jiyeon %+ College of Nursing and Mo-im Kim Nursing Research Institute, Yonsei Evidence Based Nursing Center of Korea: Affiliation of the Joanna Briggs Institution, Yonsei University, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea, 82 2228 3255, Jiyeonest@yuhs.ac %K digital health %K adult %K neoplasms %K randomized controlled trial %K mobile phone %D 2023 %7 6.1.2023 %9 Review %J J Med Internet Res %G English %X Background: Digital care has become an essential component of health care. Interventions for patients with cancer need to be effective and safe, and digital health interventions must adhere to the same requirements. Objective: The purpose of this study was to identify currently available digital health interventions developed and evaluated in randomized controlled trials (RCTs) targeting adult patients with cancer. Methods: A scoping review using the JBI methodology was conducted. The participants were adult patients with cancer, and the concept was digital health interventions. The context was open, and sources were limited to RCT effectiveness studies. The PubMed, CINAHL, Embase, Cochrane Library, Research Information Sharing Service, and KoreaMed databases were searched. Data were extracted and analyzed to achieve summarized results about the participants, types, functions, and outcomes of digital health interventions. Results: A total of 231 studies were reviewed. Digital health interventions were used mostly at home (187/231, 81%), and the web-based intervention was the most frequently used intervention modality (116/231, 50.2%). Interventions consisting of multiple functional components were most frequently identified (69/231, 29.9%), followed by those with the self-manage function (67/231, 29%). Web-based interventions targeting symptoms with the self-manage and multiple functions and web-based interventions to treat cognitive function and fear of cancer recurrence consistently achieved positive outcomes. More studies supported the positive effects of web-based interventions to inform decision-making and knowledge. The effectiveness of digital health interventions targeting anxiety, depression, distress, fatigue, health-related quality of life or quality of life, pain, physical activity, and sleep was subject to their type and function. A relatively small number of digital health interventions specifically targeted older adults (6/231, 2.6%) or patients with advanced or metastatic cancer (22/231, 9.5%). Conclusions: This scoping review summarized digital health interventions developed and evaluated in RCTs involving adult patients with cancer. Systematic reviews of the identified digital interventions are strongly recommended to integrate digital health interventions into clinical practice. The identified gaps in digital health interventions for cancer care need to be reflected in future digital health research. %M 36607712 %R 10.2196/38333 %U https://www.jmir.org/2023/1/e38333 %U https://doi.org/10.2196/38333 %U http://www.ncbi.nlm.nih.gov/pubmed/36607712 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e38204 %T Cost-effectiveness of Internet Interventions Compared With Treatment as Usual for People With Mental Disorders: Systematic Review and Meta-analysis of Randomized Controlled Trials %A Rohrbach,Pieter J %A Dingemans,Alexandra E %A Evers,Catharine %A Van Furth,Eric F %A Spinhoven,Philip %A Aardoom,Jiska J %A Lähde,Irene %A Clemens,Fleur C %A Van den Akker-Van Marle,M Elske %+ GGZ Rivierduinen Eating Disorders Ursula, Sandifortdreef 19, PO Box 405, Leiden, 2300 AK, Netherlands, 31 634642298, p.j.rohrbach@lumc.nl %K economic evaluation %K cost-benefit analysis %K methods of economic evaluation %K meta-analysis %K eHealth %K internet-based interventions %K mental disorders %K mental health %K systematic review %K randomized controlled trial %K mobile phone %D 2023 %7 5.1.2023 %9 Review %J J Med Internet Res %G English %X Background: The economic costs of mental disorders for society are huge. Internet-based interventions are often coined as cost-effective alternatives to usual care, but the evidence is mixed. Objective: The aim was to review the literature on the cost-effectiveness of internet interventions for mental disorders compared with usual care and to provide an estimate of the monetary benefits of such interventions compared with usual care. Methods: A systematic review and meta-analysis of randomized controlled trials was conducted, which included participants with symptoms of mental disorders; investigated a telephone- or internet-based intervention; included a control condition in the form of treatment as usual, psychological placebo, waiting list control, or bibliotherapy; reported outcomes on both quality of life and costs; and included articles published in English. Electronic databases such as PubMed (including MEDLINE), Embase, Emcare, PsycINFO, Web of Science, and the Cochrane Library were used. Data on risk of bias, quality of the economic evaluation, quality-adjusted life years, and costs were extracted from the included studies, and the incremental net benefit was calculated and pooled. Results: The search yielded 6226 abstracts, and 37 studies with 14,946 participants were included. The quality of economic evaluations of the included studies was rated as moderate, and the risk of bias was high. A random-effects approach was maintained. Analyses suggested internet interventions were slightly more effective than usual care in terms of quality-adjusted life years gain (Hedges g=0.052, 95% CI 0.010-0.094; P=.02) and equally expensive (Hedges g=0.002, 95% CI −0.080 to 0.84; P=.96). The pooled incremental net benefit was US $255 (95% CI US $91 to US $419; P=.002), favoring internet interventions over usual care. The perspective of the economic evaluation and targeted mental disorder moderated the results. Conclusions: The findings indicate that the cost-effectiveness of internet interventions for mental disorders compared with a care-as-usual approach is likely, but generalizability to new studies is poor given the substantial heterogeneity. This is the first study in the field of mental health to pool cost-effectiveness outcomes in an aggregate data meta-analysis. Trial Registration: PROSPERO CRD42019141659; https://tinyurl.com/3cu99b34 %M 36602854 %R 10.2196/38204 %U https://www.jmir.org/2023/1/e38204 %U https://doi.org/10.2196/38204 %U http://www.ncbi.nlm.nih.gov/pubmed/36602854 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e42053 %T The PTSD Family Coach App in Veteran Family Members: Pilot Randomized Controlled Trial %A van Stolk-Cooke,Katherine %A Wielgosz,Joseph %A Hallenbeck,Haijing Wu %A Chang,Andrew %A Rosen,Craig %A Owen,Jason %A Kuhn,Eric %+ Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, 401 Quarry Rd., Palo Alto, CA, 94304, United States, 1 860 335 2021, cvscooke@stanford.edu %K posttraumatic stress disorder %K PTSD %K veterans %K family %K mobile apps %D 2023 %7 5.1.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Posttraumatic stress disorder (PTSD) among US military veterans can adversely impact their concerned significant others (CSOs; eg, family members and romantic partners). Mobile apps can be tailored to support CSO mental health through psychoeducation, coping skills, and stress monitoring. Objective: This study assessed the feasibility, acceptability, and potential efficacy of PTSD Family Coach 1.0, a free, publicly available app that includes psychoeducation, stress management tools, self-assessments, and features for connecting to alternative supports, compared with a psychoeducation-only version of the app for cohabitating CSOs of veterans with PTSD. Methods: A total of 200 participants with an average age of 39 (SD 8.44) years, primarily female (193/200, 97%), and White (160/200, 80%) were randomized to self-guided use of either PTSD Family Coach 1.0 (n=104) or a psychoeducation-only app (n=96) for 4 weeks. Caregiver burden, stress, depression, anxiety, beliefs about treatment, CSO self-efficacy, and relationship functioning assessed using measures of dyadic adjustment, social constraints, and communication danger signs were administered via a web survey at baseline and after treatment. User satisfaction and app helpfulness were assessed after treatment. Data were analyzed using linear mixed methods. Results: Overall, 50.5% (101/200) of randomized participants used their allocated app. Participants found PTSD Family Coach 1.0 somewhat satisfying (mean 4.88, SD 1.11) and moderately helpful (mean 2.99, SD 0.97) to use. Linear mixed effects models revealed no significant differences in outcomes by condition for caregiver burden (P=.45; Cohen d=0.1, 95% CI −0.2 to 0.4), stress (P=.64; Cohen d=0.1, 95% CI −0.4 to 0.6), depression (P=.93; Cohen d= 0.0, 95% CI −0.3 to 0.3), anxiety (P=.55; Cohen d=−0.1, 95% CI −0.4 to 0.2), beliefs about treatment (P=.71; Cohen d=0.1, 95% CI −0.2 to 0.3), partner self-efficacy (P=.59; Cohen d=−0.1, 95% CI −0.4 to 0.2), dyadic adjustment (P=.08; Cohen d=−0.2, 95% CI −0.5 to 0.0), social constraints (P=.05; Cohen d=0.3, 95% CI 0.0-0.6), or communication danger signs (P=.90; Cohen d=−0.0, 95% CI −0.3 to 0.3). Post hoc analyses collapsing across conditions revealed a significant between-group effect on stress for app users versus nonusers (β=−3.62; t281=−2.27; P=.02). Conclusions: Approximately half of the randomized participants never used their allocated app, and participants in the PTSD Family Coach 1.0 condition only opened the app approximately 4 times over 4 weeks, suggesting limitations to this app version’s feasibility. PTSD Family Coach 1.0 users reported moderately favorable impressions of the app, suggesting preliminary acceptability. Regarding efficacy, no significant difference was found between PTSD Family Coach 1.0 users and psychoeducation app users across any outcome of interest. Post hoc analyses suggested that app use regardless of treatment condition was associated with reduced stress. Further research that improves app feasibility and establishes efficacy in targeting the domains most relevant to CSOs is warranted. Trial Registration: ClinicalTrials.gov NCT02486705; https://clinicaltrials.gov/ct2/show/NCT02486705 %M 36602852 %R 10.2196/42053 %U https://formative.jmir.org/2023/1/e42053 %U https://doi.org/10.2196/42053 %U http://www.ncbi.nlm.nih.gov/pubmed/36602852 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e37270 %T Assessment and Disruption of Ruminative Episodes to Enhance Mobile Cognitive Behavioral Therapy Just-in-Time Adaptive Interventions in Clinical Depression: Pilot Randomized Controlled Trial %A Wang,Liyuan %A Miller,Lynn %+ Children's Hospital, Los Angeles, Department of Adolescent and Young Adult, 3250 Wilshire Blvd, Suite 1202, Los Angeles, CA, 90027-0000, United States, 1 7654911022, liwang@chla.usc.edu %K depressive rumination %K mobile health %K mHealth %K just-in-time adaptive intervention %K depression %K mental health %K mobile phone %D 2023 %7 5.1.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: A just-in-time adaptive intervention (JITAI) is “designed to address the dynamically changing needs of individuals via the provision of the type or amount of support needed, at the right time when needed.” If and how rumination-focused cognitive behavioral therapy (RFCBT), the gold standard, blocks emotional cascades underlying rumination is unclear. Furthermore, cognitive behavioral therapy has been successfully used as a mobile variant, but RFCBT has not been adapted for a mobile variant (mobile RFCBT [MRFCBT]) or for a JITAI variant. Objective: This study aimed to pilot-test a fully automated JITAI leveraging RFCBT and ways to identify and block cascading depressive rumination. Methods: Patients in therapy for clinical depression were recruited for a randomized controlled trial (RCT). After consenting to be part of the RCT, they were randomly assigned to either of the 2 mobile versions of the RFCBT conditions personalized to the individual’s rumination timing patterns (JITAI-MRFCBT) or a no-treatment control condition through a double-blind procedure. Although the initial design was to have a 3-armed trial with 2 JITAI conditions (a JITAI and a narrative JITAI condition), we later opted to collapse those 2 conditions into 1 JITAI condition because of the low number of participants. All participants were recruited and participated through their smartphones, receiving 5 SMS text message reminders on each of the 35 days to self-report their rumination-related symptoms (eg, rumination episodes and duration). In the JITAI-MRFCBT condition, they also received treatment materials. The first 7 days provided a rumination baseline, and the last 7 days provided a postintervention rumination value. In total, 42% (25/59) of volunteers were eligible and provided their phone numbers, 20% (5/25) of whom never replied to the SMS text message reminding them to start the RCT. A total of 90% (18/20) of volunteers completed it (ie, finishing, as prespecified, 80% of the questionnaires and training tasks) and, therefore, were included in the analysis. Results: Using independent 2-tailed t tests with bootstrapping, results showed that participants in the JITAI-MRFCBT condition, compared with those in the control condition, reported a greater reduction in counts of rumination episodes (mean −25.28, SD 14.50 vs mean 1.44, SD 4.12, P<.001) and greater reduced average time (minutes) spent in rumination (mean −21.53, SD 17.6 vs mean 1.47, SD 1.5; P=.04). Results also suggest that, compared with those in the control group, those in treatment reduced ruminative carryover from one episode to the next. Conclusions: The results suggest that JITAI-MRFCBT may reduce negative rumination by providing RFCBT just in time following rumination, thereby blocking the next rumination episode using the same trigger. This study supports a subsequent, full-scale JITAI and the importance of leveraging mobile smartphone technology with MRFCBT to curb depressive symptoms. Trial Registration: ClinicalTrials.gov NCT04554706; https://clinicaltrials.gov/ct2/show/NCT04554706 %M 36602841 %R 10.2196/37270 %U https://formative.jmir.org/2023/1/e37270 %U https://doi.org/10.2196/37270 %U http://www.ncbi.nlm.nih.gov/pubmed/36602841 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 6 %N %P e39848 %T Digital Intergenerational Program to Reduce Loneliness and Social Isolation Among Older Adults: Realist Review %A Phang,Jie Kie %A Kwan,Yu Heng %A Yoon,Sungwon %A Goh,Hendra %A Yee,Wan Qi %A Tan,Chuen Seng %A Low,Lian Leng %+ Health Systems and Services Research, Duke-NUS Medical School, 8 College Rd, Singapore, 169857, Singapore, 65 90231226, phakyh@nus.edu.sg %K aged %K loneliness %K older people %K review %K social isolation %D 2023 %7 4.1.2023 %9 Review %J JMIR Aging %G English %X Background: There is a compelling need for an innovative and creative approach to promote social connectedness among older adults to optimize their well-being and quality of life. One possible solution may be through a digital intergenerational program. Objective: This realist review aimed to identify existing digital intergenerational programs that were used to reduce loneliness or social isolation among older adults and analyze them in terms of strategy, context, mechanisms, and outcomes. Methods: We performed a realist review with an extensive search of published and gray literature. For scholarly literature, we searched PubMed, Embase, CINAHL, PsycINFO (Ovid), and Social Sciences Citation Index databases for articles published between January 2000 to August 2020. A grey literature search was performed using the Google search engine, and the search was completed in May 2021. We included programs that evaluated digital intergenerational programs for older adults, which described outcomes of loneliness or social isolation. We included quantitative, mixed methods, and qualitative studies, as well as relevant theoretical papers, policy documents, and implementation documents. The studies were appraised based on their relevance and rigor. We synthesized the available evidence from the literature into Strategy-Context-Mechanism-Outcome (S-C-M-O) configurations to better understand what, when, and how programs work. Results: A total of 31 documents reporting 27 digital intergenerational programs were reviewed. Our final results identified 4 S-C-M-O configurations. For S-C-M-O configuration 1, we found that for community-dwelling older adults, provision of access to and training in digital technology may increase older adults’ self-efficacy in digital devices and therefore increase the use of digital communication with family. In S-C-M-O configuration 2, digital psychosocial support and educational interventions from nurses were found to be useful in reducing loneliness among community-dwelling older adults. In S-C-M-O configuration 3, a video call with a student or family was found to reduce loneliness among older adults residing in long-term residential care facilities. Finally, for S-C-M-O configuration 4, we found that behavioral activation provided through videoconferencing by a lay coach may be useful in reducing loneliness among older adults who are lonely. However, as almost half (11/27, 41%) of the included programs only reported quantitative results, this review focused on screening the discussion section of publications to identify author opinions or any qualitative information to elucidate the mechanisms of how programs work. Conclusions: This review identified the key strategy, context, and mechanism influencing the success of programs that promote intergenerational interaction through digital means. This review revealed that different strategies should be adopted for different groups of older adults (eg, older adults who are lonely, older adults who reside in long-term residential care facilities, and community-dwelling older adults). The S-C-M-O configurations should be considered when designing and implementing digital intergenerational programs for older adults. %M 36598801 %R 10.2196/39848 %U https://aging.jmir.org/2023/1/e39848 %U https://doi.org/10.2196/39848 %U http://www.ncbi.nlm.nih.gov/pubmed/36598801 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 12 %P e36806 %T Patient and Therapist Expectations for a Blended Cognitive Behavioral Therapy Program for Depression: Qualitative Exploratory Study %A Atik,Ece %A Schückes,Magnus %A Apolinário-Hagen,Jennifer %+ Institute for SME Research and Entrepreneurship, University of Mannheim, L 9, 1–2, Mannheim, 68161, Germany, 49 621 181 2273, schueckes@bwl.uni-mannheim.de %K blended cognitive behavioral therapy %K bCBT %K cognitive behavioral therapy %K digital health %K mental health %K internet %K mobile app %K blended psychotherapy %K depression %K user perspectives %K mobile phone %D 2022 %7 30.12.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Blended cognitive behavioral therapy (bCBT)—the combination of digital elements and face-to-face psychotherapy—has been proposed to alleviate challenges that patients and therapists face in conventional cognitive behavioral therapy. There is growing evidence that adding digital elements to face-to-face psychotherapy can contribute to better treatment outcomes. However, bCBT programs still show considerable shortcomings, and knowledge on how to improve digital apps using a bCBT protocol is limited. Objective: This study aimed to inductively identify functions and qualities that are expected from a bCBT treatment for depression in the eyes of patients and psychotherapists who were not currently receiving or practicing bCBT treatment. Methods: We used a qualitative exploratory study design and conducted 3 focus group interviews (n=6 in each) and 5 semistructured in-depth interviews with therapists as well as 11 individual interviews with patients with a primary diagnosis of depression and currently undergoing cognitive behavioral therapy treatment in Germany. Themes and categories were established inductively from transcribed interview records based on a rigorous coding method. Results: Both therapists and patients expected a digital app to provide patients with the opportunity to track their mood, work on therapeutic homework activities, easily access an intervention set for harder moments, and efficiently facilitate administrative tasks. The desire to be able to customize bCBT protocols to individual patient circumstances was evident in both patient and therapist interviews. Patients differed with respect to what content and the amount of material the app should focus on as well as the method of recording experiences. Therapists viewed digital apps as potentially aiding in their documentation work outside of sessions. Different attitudes surfaced on the topic of data security, with patients not as concerned as therapists. Conclusions: Both patients and therapists had substantially positive attitudes toward the option of an integrated bCBT treatment. Our study presents novel findings on the expectations and attitudes of patients and therapists. %M 36583934 %R 10.2196/36806 %U https://mental.jmir.org/2022/12/e36806 %U https://doi.org/10.2196/36806 %U http://www.ncbi.nlm.nih.gov/pubmed/36583934 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 12 %P e38748 %T The Acceptance, Usability, and Utility of a Web Portal for Back Pain as Recommended by Primary Care Physicians: Qualitative Interview Study With Patients %A Schlett,Christian %A Röttele,Nicole %A van der Keylen,Piet %A Schöpf-Lazzarino,Andrea Christina %A Klimmek,Miriam %A Körner,Mirjam %A Schnitzius,Kathrin %A Voigt-Radloff,Sebastian %A Maun,Andy %A Sofroniou,Mario %A Farin-Glattacker,Erik %+ Section of Health Care Research and Rehabilitation Research, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Hugstetter Str. 49, Freiburg, 79106, Germany, 49 27083732, christian.schlett@uniklinik-freiburg.de %K general practice %K primary care %K lower back pain %K digital health intervention %K web-based health information %K eHealth %K patient education %K adherence %K qualitative research %K framework analysis %K mobile phone %D 2022 %7 29.12.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: An ever-increasing number of patients seek health information via the internet. However, there is an overabundance of differing, often low-quality information available, while a lack of health literacy makes it difficult for patients to understand and assess the quality and trustworthiness of the information at hand. The web portal tala-med was thus conceived as an evidence-based, up-to-date, and trustworthy information resource for lower back pain (LBP), which could be used by primary care physicians (PCPs) and patients during and following consultations for LBP. The current evidence demonstrates that patients with LBP could benefit from web portals. However, the use of such portals by patients remains low, thus limiting their effectiveness. Therefore, it is important to explore the factors that promote or hinder the use of web portals and investigate how patients perceive their usability and utility. Objective: In this study, we investigated the acceptance, usability, and utility of the web portal tala-med from the patient perspective. Methods: This qualitative study was based on telephone interviews with patients who had access to the web portal tala-med from their PCP. We used a semistructured interview guide that consisted of questions about the consultation in which patients were introduced to tala-med, in addition to questions regarding patient perceptions, experiences, and utilization of tala-med. The interviews were recorded, transcribed, and analyzed through framework analysis. Results: A total of 32 half-hour interviews were conducted with 16 female and 16 male patients with LBP. We identified 5 themes of interest: the use of tala-med by PCPs during the consultation, the use of tala-med by patients, its usability, added values derived from its use, and the resultant effects of using tala-med. PCPs used tala-med as an additional information resource for their patients and recommended the exercises. The patients appreciated these exercises and were willing to use tala-med at home. We also identified factors that promoted or hindered the use of tala-med by patients. Most patients rated tala-med positively and considered it a clear, comprehensible, trustworthy, and practical resource. In particular, the trustworthiness of tala-med was seen as an advantage over other information resources. The possibilities offered by tala-med to recap and reflect on the contents of consultations in a time-flexible and independent manner was perceived as an added value to the PCP consultation. Conclusions: Tala-med was well accepted by patients and appeared to be well suited to being used as an add-on to PCP consultations. Patient perception also supports its usability and utility. Tala-med may therefore enrich consultations and assist patients who would otherwise be unable to find good-quality web-based health information on LBP. In addition, our findings support the future development of digital health platforms and their successful use as a supplement to PCP consultations. International Registered Report Identifier (IRRID): RR2-10.1186/s12875-019-0925-8 %M 36580365 %R 10.2196/38748 %U https://formative.jmir.org/2022/12/e38748 %U https://doi.org/10.2196/38748 %U http://www.ncbi.nlm.nih.gov/pubmed/36580365 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 12 %P e42526 %T General Practice Patients’ Experiences and Perceptions of the WiserAD Structured Web-Based Support Tool for Antidepressant Deprescribing: Protocol for a Mixed Methods Case Study With Realist Evaluation %A Coe,Amy %A Gunn,Jane %A Kaylor-Hughes,Catherine %+ Department of General Practice, University of Melbourne, Level 2, 780 Elizabeth St, Melbourne, 3004, Australia, 61 90356335, amy.coe@unimelb.edu.au %K antidepressants %K primary care %K depression %K deprescribing %K realist evaluation %K online support tool %K case study %K general practice %K online %K tool %K data %K evaluation %K intervention %K clinical %D 2022 %7 29.12.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Research suggests that the rapid increase in worldwide antidepressant use is mainly due to a rise in long-term and potentially inappropriate use. It has been suggested that 1 in 3 antidepressant users among general practice patients are no longer experiencing clinical benefits from their medication and should commence deprescribing. However there are many barriers to antidepressant deprescribing for both patients and clinicians, which adds to the complex nature of reducing or ceasing the medication. As such, antidepressant deprescribing does not routinely occur in clinical practice. Evidence-based supports and interventions for safe and successful antidepressant deprescribing are needed to assist patients and their doctors. Interventions should also include an understanding of how an intervention works, why it works, and whom it is for. Objective: This study aims to evaluate how the WiserAD approach to antidepressant deprescribing works, whom it is for, and the underlying circumstances by (1) examining the experiences and perceptions of WiserAD among antidepressant users, (2) identifying the underlying mechanisms of the WiserAD approach to antidepressant deprescribing, and (3) describing in what contexts and to what extent the underlying mechanisms of WiserAD are suited for antidepressant users. Methods: A mixed methods case study with realist evaluation will be conducted among participants in the WiserAD randomized controlled trial for antidepressant deprescribing. Quantitative data will be obtained from up to 12 participants from the intervention and control arms at baseline and 3-month follow-up. Baseline data will be used to characterize the sample using descriptive statistics. Paired samples t tests will also be performed to compare responses between baseline and 3-month follow-up for participant self-management, skills, confidence and knowledge, beliefs about medicines, current emotional health, and well-being symptoms. Qualitative data from the same participants will be collected via narrative interview at 3-month follow-up. Quantitative and qualitative data will be converged to form a “case,” and analysis will be conducted within each case with comparisons made across multiple cases. Results: Recruitment of participants commenced in October 2022 and will be completed by March 2023. Analysis will be completed by June 2023. Conclusions: To our knowledge, this will be the first realist evaluation of an antidepressant deprescribing intervention in general practice. Findings from this evaluation may assist in the implementation of the WiserAD approach to antidepressant deprescribing in routine clinical practice. International Registered Report Identifier (IRRID): PRR1-10.2196/42526 %M 36580362 %R 10.2196/42526 %U https://www.researchprotocols.org/2022/12/e42526 %U https://doi.org/10.2196/42526 %U http://www.ncbi.nlm.nih.gov/pubmed/36580362 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 12 %P e42301 %T Leveraging Mobile Health to Manage Mental Health/Behavioral Health Disorders: Systematic Literature Review %A Kruse,Clemens Scott %A Betancourt,Jose A %A Gonzales,Matthew %A Dickerson,Kennedy %A Neer,Miah %+ School of Health Administration, Texas State University, 601 University Drive, Encino, 250, San Marcos, TX, 78666, United States, 1 512 245 4462, scottkruse@txstate.edu %K mHealth %K telemedicine %K mental health %K behavioral health %K anxiety %K mobile device %K smartphone %K SMS text messaging %K RCT %D 2022 %7 27.12.2022 %9 Review %J JMIR Ment Health %G English %X Background: Mental health is a complex condition, highly related to emotion. The COVID-19 pandemic caused a significant spike in depression (from isolation) and anxiety (event related). Mobile Health (mHealth) and telemedicine offer solutions to augment patient care, provide education, improve symptoms of depression, and assuage fears and anxiety. Objective: This review aims to assess the effectiveness of mHealth to provide mental health care by analyzing articles published in the last year in peer-reviewed, academic journals using strong methodology (randomized controlled trial). Methods: We queried 4 databases (PubMed, CINAHL [Cumulative Index to Nursing and Allied Health Literature], Web of Science, and ScienceDirect) using a standard Boolean search string. We conducted this systematic literature review in accordance with the Kruse protocol and reported it in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) 2020 checklist (n=33). Results: A total of 4 interventions (mostly mHealth) from 14 countries identified improvements in primary outcomes of depression and anxiety as well as in several secondary outcomes, namely, quality of life, mental well-being, cognitive flexibility, distress, sleep, self-efficacy, anger, decision conflict, decision regret, digestive disturbance, pain, and medication adherence. Conclusions: mHealth interventions can provide education, treatment augmentation, and serve as the primary modality in mental health care. The mHealth modality should be carefully considered when evaluating modes of care. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42022343489; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=343489 %M 36194896 %R 10.2196/42301 %U https://mental.jmir.org/2022/12/e42301 %U https://doi.org/10.2196/42301 %U http://www.ncbi.nlm.nih.gov/pubmed/36194896 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 12 %P e32705 %T The Role of Dysfunctional Sleep Beliefs in Mediating the Outcomes of Web-Based Cognitive Behavioral Therapy for Insomnia in Community-Dwelling Older Adults: Protocol for a Single-Group, Nonrandomized Trial %A Kutzer,Yvonne %A Whitehead,Lisa %A Quigley,Eimear %A Stanley,Mandy %+ School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, 6027, Australia, 61 8 6304 5656, yvonnek@our.ecu.edu.au %K older adults %K insomnia %K cognitive therapy %K digital literacy %K cognitive behavioral therapy for insomnia (CBT-I) %K online psychological intervention %D 2022 %7 27.12.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Sleeping well is an essential part of good health. Older adult populations report a high rate of sleep problems, with recent studies suggesting that cognitive processes as well as behavioral and hyperarousal-related mechanisms could be important factors in the development and maintenance of insomnia. Individuals who have an asynchronous or uncoupled sleep pattern and sleep appraisal—those who complain about their sleep but do not have poor sleep quality, and vice versa—might show differences in subjective sleep and sleep perceptions and other characteristics that could impact their treatment outcomes following cognitive behavioral therapy for insomnia (CBT-I). Objective: The purpose of this protocol is to describe the rationale and methods for a nonrandomized, single-arm trial assessing objective and subjective sleep quality in community-dwelling older adults aged 60-80 years with synchronous sleep patterns and sleep appraisal compared to those in older adults with asynchronous sleep patterns and sleep appraisal. The trial will further examine the role of cognitive, behavioral, and hyperarousal processes in mediating the treatment outcomes of web-based CBT-I. Methods: This trial aims to recruit a sample of 60 participants, who will be assigned to 1 of 4 sleep groups based on their sleep pattern and sleep appraisal status: complaining good sleepers, complaining poor sleepers, noncomplaining good sleepers, and noncomplaining poor sleepers, respectively. The trial will be completed in 2 phases: phase 1 will assess objective sleep (measured via wrist actigraphy) and subjective (self-reported) sleep. Phase 2 will investigate the impact of a web-based CBT-I program on the sleep outcomes of individuals with uncoupled sleep compared to that of individuals without uncoupled sleep, as well as the mediators of CBT-I. Results: Recruitment began in March 2020, and the last participants were recruited by March 2021. A total of 65 participants completed phases 1 and 2. Data analysis for phase 1 was finished in December 2021, and data analysis for phase 2 was finalized in July 2022. The results for phase 1 were submitted for publication in March 2022, and those for phase 2 will be submitted by the end of December 2022. Conclusions: This trial will provide guidance on factors that contribute to the variability of sleep in older adults and their sleep outcomes following CBT-I. The outcomes of this study could be valuable for future research attempting to tailor CBT-I to individual needs. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619001509156; https://tinyurl.com/69hhdu2w International Registered Report Identifier (IRRID): DERR1-10.2196/32705 %M 36574272 %R 10.2196/32705 %U https://www.researchprotocols.org/2022/12/e32705 %U https://doi.org/10.2196/32705 %U http://www.ncbi.nlm.nih.gov/pubmed/36574272 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 12 %P e37467 %T Web-Based Short Video Intervention and Short Message Comparison of Repeat Blood Donation Behavior Based on an Extended Theory of Planned Behavior: Prospective Randomized Controlled Trial Study %A Hu,Qiuyue %A Hu,Wei %A Han,Wenjuan %A Pan,Lingling %+ Blood Center of Zhejiang Province, 789 Jianye Road, Binjiang District, Hangzhou, 310052, China, 86 13588809060, panbbs@163.com %K extended theory of planned behavior %K repeated blood donation intervention %K randomized controlled trial %K mobile phone %D 2022 %7 23.12.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Although blood is an indispensable and important resource for clinical treatment, an imbalance between supply and demand may occur as the population ages and diversifies. Studies indicate that repeat blood donors are safe blood sources because of their voluntary blood donation education and frequent blood screening. However, the high rate of reduction in the number of first-time voluntary blood donors and low rate of repeated blood donation are common problems worldwide. Objective: This study aimed to evaluate the effect of an intervention in nonregular blood donors using web-based videos and SMS text messages, in which the former was guided by the extended theory of planned behavior, to discover effective intervention methods to improve repeat blood donation rates among nonregular blood donors. Methods: A total of 692 nonregular blood donors in Zhejiang province were randomly divided into intervention and control groups. The control group received regular, short reminder messages for a 6-month period, whereas the intervention group received web-based videos on the WeChat platform. The intervention group was guided by an extended theory of planned behavior, which included 9 factors: the respondents’ attitude, subjective behavioral norms, perceived behavioral control, the willingness to donate blood, outcome expectations, self-identity, blood donation–related anxiety, cognition of the blood donation environment, and previous blood donation experience. The intervention group was divided into 2 stages: those with an intervention at 3 months and those with a follow-up 3 months later. After 6 months, the redonation rate was evaluated for the 2 groups, and the scale in the intervention group was determined both before and after the intervention. A t test, chi-square test, logistic stepwise regression, and ANOVA were performed. Results: The intervention group’s redonation rate was 16.14%, which was significantly higher than the control group’s redonation rate of 5.16%; P<.001. Men who were aged 31 to 45 years and had donated blood twice had a higher redonation rate after the web-based video intervention than after the SMS text messages; P<.05. The repeat donors’ improved blood donation anxiety (P=.01), outcome expectations (P=.008), and cognition of the blood donation environment (P=.005) after the intervention were significantly higher than those of the nonrepeat donors. Conclusions: The web-based short video intervention based on the extended theory of planned behavior can effectively improve redonation rates. Outcome expectations, blood donation anxiety, and cognition of the blood donation environment can directly influence irregular blood donors to redonate blood. %M 36379691 %R 10.2196/37467 %U https://www.jmir.org/2022/12/e37467 %U https://doi.org/10.2196/37467 %U http://www.ncbi.nlm.nih.gov/pubmed/36379691 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 4 %P e40933 %T Preferences for a Mental Health Support Technology Among Chinese Employees: Mixed Methods Approach %A Sun,Sijin %A Zhang,Zheyuan %A Tian,Mu %A Mougenot,Celine %A Glozier,Nick %A Calvo,Rafael A %+ Dyson School of Design Engineering, Imperial College London, Imperial College Rd, South Kensington, London, SW7 9EG, United Kingdom, 44 779967397, s.sun20@imperial.ac.uk %K mental health %K digital health %K workplace %K China %D 2022 %7 22.12.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Workplace mental health is under-studied in China, making it difficult to design effective interventions. To encourage the engagement with interventions, it is crucial to understand employees’ motivation toward seeking help through technologies. Objective: This study aimed to understanding how Chinese employees view digital mental health support technology and how mental health support technology could be designed to boost the motivation of Chinese employees to use it. Methods: A mixed methods approach was used. In total, 458 Chinese employees (248/458, 54% female) in 5 industries (manufacturing, software, medical, government, and education) responded to a survey, and 14 employees and 5 managers were interviewed. Results: Government data and employee responses showed that mental health support in China is limited. In the workplace, Chinese employees experience a lower sense of autonomy satisfaction compared with competence and relatedness. Although managers and employees try to empathize with those who have mental health issues, discrimination and the stigma of mental illness are rife in Chinese workplaces. Digital technologies are perceived as a potential medium for mental health interventions; however, privacy is a major concern. Conclusions: The results of this study demonstrated the potential of self-help digital mental health support for Chinese employees. Interdisciplinary cooperation between design engineers and mental health researchers can contribute toward understanding the issues that engage or disengage users with digital mental health interventions. %M 36548027 %R 10.2196/40933 %U https://humanfactors.jmir.org/2022/4/e40933 %U https://doi.org/10.2196/40933 %U http://www.ncbi.nlm.nih.gov/pubmed/36548027 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 12 %P e38471 %T Evaluating User Preferences, Comprehension, and Trust in Apps for Environmental Health Hazards: Qualitative Case Study %A Workman,Annabelle %A Johnston,Fay H %A Campbell,Sharon L %A Williamson,Grant J %A Lucani,Chris %A Bowman,David M J S %A Cooling,Nick %A Jones,Penelope J %+ Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool Street, Hobart, 7000, Australia, 61 362267726, penelope.jones@utas.edu.au %K health app %K evaluation %K air pollution %K pollen %K temperature %K mobile phone %D 2022 %7 22.12.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Climate change is projected to increase environmental health hazard risks through fire-related air pollution and increased airborne pollen levels. To protect vulnerable populations, it is imperative that evidence-based and accessible interventions are available. The environmental health app, AirRater, was developed in 2015 in Australia to provide information on multiple atmospheric health hazards in near real time. The app allows users to view local environmental conditions, and input and track their personal symptoms to enable behaviors that protect health in response to environmental hazards. Objective: This study aimed to develop insights into users’ perceptions of engagement, comprehension, and trust in AirRater to inform the future development of environmental health apps. Specifically, this study explored which AirRater features users engaged with, what additional features or functionality needs users felt they required, users’ self-perception of understanding app information, and their level of trust in the information provided. Methods: A total of 42 adult AirRater users were recruited from 3 locations in Australia to participate in semistructured interviews to capture location- or context-specific experiences. Participants were notified of the recruitment opportunity through multiple avenues including newsletter articles and social media. Informed consent was obtained before participation, and the participants were remunerated for their time and perspectives. A preinterview questionnaire collected data including age range, any preexisting conditions, and location (postcode). All participant data were deidentified. Interviews were recorded, transcribed, and analyzed using thematic analysis in NVivo 12 (QSR International). Results: Participants discussed app features and functionality, as well as their understanding of, and trust in, the information provided by the app. Most (26/42, 62%) participants used and valued visual environmental hazard features, especially maps, location settings, and hazard alerts. Most (33/42, 78%) found information in the app easy to understand and support their needs, irrespective of their self-reported literacy levels. Many (21/42, 50%) users reported that they did not question the accuracy of the data presented in the app. Suggested enhancements include the provision of meteorological information (eg, wind speed or direction, air pressure, UV rating, and humidity), functionality enhancements (eg, forecasting, additional alerts, and the inclusion of health advice), and clarification of existing information (eg, symptom triggers), including the capacity to download personal summary data for a specified period. Conclusions: Participants’ perspectives can inform the future development of environmental health apps. Specifically, participants’ insights support the identification of key elements for the optimal development of environmental health app design, including streamlining, capacity for users to customize, use of real time data, visual cues, credibility, and accuracy of data. The results also suggest that, in the future, iterative collaboration between developers, environmental agencies, and users will likely promote better functional design, user trust in the data, and ultimately better population health outcomes. %M 36548030 %R 10.2196/38471 %U https://formative.jmir.org/2022/12/e38471 %U https://doi.org/10.2196/38471 %U http://www.ncbi.nlm.nih.gov/pubmed/36548030 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 12 %P e41042 %T Digital Biomarker–Based Interventions: Systematic Review of Systematic Reviews %A Motahari-Nezhad,Hossein %A Al-Abdulkarim,Hana %A Fgaier,Meriem %A Abid,Mohamed Mahdi %A Péntek,Márta %A Gulácsi,László %A Zrubka,Zsombor %+ Health Economics Research Center, University Research and Innovation Center, Óbuda University, Budapest, Bécsi út 96/B, Budapest, 1034, Hungary, 36 702097967, h.motahari.lib@gmail.com %K digital biomarker %K digital health %K digital devices %K AMSTAR-2 %K GRADE %K methodological quality %K evidence synthesis %K publication bias %K imprecision %K implantable %K wearable %D 2022 %7 21.12.2022 %9 Review %J J Med Internet Res %G English %X Background: The introduction of new medical technologies such as sensors has accelerated the process of collecting patient data for relevant clinical decisions, which has led to the introduction of a new technology known as digital biomarkers. Objective: This study aims to assess the methodological quality and quality of evidence from meta-analyses of digital biomarker–based interventions. Methods: This study follows the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guideline for reporting systematic reviews, including original English publications of systematic reviews reporting meta-analyses of clinical outcomes (efficacy and safety endpoints) of digital biomarker–based interventions compared with alternative interventions without digital biomarkers. Imaging or other technologies that do not measure objective physiological or behavioral data were excluded from this study. A literature search of PubMed and the Cochrane Library was conducted, limited to 2019-2020. The quality of the methodology and evidence synthesis of the meta-analyses were assessed using AMSTAR-2 (A Measurement Tool to Assess Systematic Reviews 2) and GRADE (Grading of Recommendations, Assessment, Development, and Evaluations), respectively. This study was funded by the National Research, Development and Innovation Fund of Hungary. Results: A total of 25 studies with 91 reported outcomes were included in the final analysis; 1 (4%), 1 (4%), and 23 (92%) studies had high, low, and critically low methodologic quality, respectively. As many as 6 clinical outcomes (7%) had high-quality evidence and 80 outcomes (88%) had moderate-quality evidence; 5 outcomes (5%) were rated with a low level of certainty, mainly due to risk of bias (85/91, 93%), inconsistency (27/91, 30%), and imprecision (27/91, 30%). There is high-quality evidence of improvements in mortality, transplant risk, cardiac arrhythmia detection, and stroke incidence with cardiac devices, albeit with low reporting quality. High-quality reviews of pedometers reported moderate-quality evidence, including effects on physical activity and BMI. No reports with high-quality evidence and high methodological quality were found. Conclusions: Researchers in this field should consider the AMSTAR-2 criteria and GRADE to produce high-quality studies in the future. In addition, patients, clinicians, and policymakers are advised to consider the results of this study before making clinical decisions regarding digital biomarkers to be informed of the degree of certainty of the various interventions investigated in this study. The results of this study should be considered with its limitations, such as the narrow time frame. International Registered Report Identifier (IRRID): RR2-10.2196/28204 %M 36542427 %R 10.2196/41042 %U https://www.jmir.org/2022/12/e41042 %U https://doi.org/10.2196/41042 %U http://www.ncbi.nlm.nih.gov/pubmed/36542427 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 12 %P e34754 %T Factors Associated With Intention and Use of e–Mental Health by Mental Health Counselors in General Practices: Web-Based Survey %A De Veirman,Ann E M %A Thewissen,Viviane %A Spruijt,Matthijs G %A Bolman,Catherine A W %+ Faculty of Psychology, Open University of the Netherlands, valkenburgerweg 177, Heerlen, 6419 AT, Netherlands, 31 455762626, catherine.bolman@ou.nl %K mental health counselors %K general practices %K e–mental health %K adoption readiness %K eligibility for e–mental health %K e–mental health use %K mental health %K eHealth %D 2022 %7 20.12.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Mental health care counselors have a high intention to use e–mental health (EMH), whereas actual use is limited. Facilitating future use requires insight into underlying factors as well as eligibility criteria that mental health care counselors use in their decision to apply EMH. Objective: The aim of this study was to unfold the intention and underlying reasons for mental health counselors to use EMH and to unveil the criteria they use to estimate patient eligibility for EMH. The theoretical framework was based on the reasoned action approach model, the Unified Theory of Acceptance and Use of Technology, and the Measurement Instrument for Determinants of Innovation model. Methods: To empirically validate our theoretical model, a web-based survey was conducted among mental health care counselors (n=132). To unveil the eligibility criteria, participants were asked to rank their reasons for considering EMH suitable or unsuitable for a patient. Results: The mean intention to use EMH was positive (mean 4.04, SD 0.64). The mean use of EMH before the COVID-19 pandemic was 38% (mean 0.38, SD 0.22), and it was 49% (mean 0.49, SD 0.25) during the pandemic. In total, 57% of the patient population was considered eligible for EMH. Usefulness and benefits (β=.440; P<.001), Task perception (β=.306; P=.001), and Accessibility (β=.140; P=.02) explained the intention to use EMH (F3,131=54.151; P<.001; R2=0.559). In turn, intention explained patient eligibility (F1,130=34.716; P<.001; R2=0.211), whereas intention and patient eligibility explained EMH use (F2,129=41.047; P<.001; R2=0.389). Patient eligibility partially mediated the relationship between intention to use EMH and EMH use, with a larger direct effect (c′=0.116; P<.001) than indirect effect (c=0.065, 95% CI 0.035-0.099; P<.001). Mental health counselors assessed patients’ eligibility for EMH mainly through the availability of computers and the internet and patient motivation. Conclusions: To stimulate the use of EMH, intention and patient eligibility need to be influenced. Intention, in turn, can be enhanced by addressing the perceived usefulness and benefits of EMH, perceived accessibility, and task perception. Access to a computer and patients’ motivation to use EMH are important in facilitating patient eligibility. To cause an impact with EMH in general practice, mental health counselors need to be convinced of the benefits of EMH and transfer this enthusiasm to the patient. It is recommended to involve mental health counselors in the development of EMH to increase the (perceived) added value and use. %M 36538357 %R 10.2196/34754 %U https://formative.jmir.org/2022/12/e34754 %U https://doi.org/10.2196/34754 %U http://www.ncbi.nlm.nih.gov/pubmed/36538357 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 12 %P e39799 %T Effect of Mobile Phone App–Based Interventions on Quality of Life and Psychological Symptoms Among Adult Cancer Survivors: Systematic Review and Meta-analysis of Randomized Controlled Trials %A Qin,Minghui %A Chen,Bo %A Sun,Shaohua %A Liu,Xiaodong %+ Information Center, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Art and Science, No 136, Jingzhou Street, Xiangcheng District, Xiangyang, 441021, China, 86 18602770213, lxd20000@163.com %K mobile health app %K mHealth app %K quality of life %K psychological symptoms %K cancer survivors %K systematic review and meta-analysis %K mobile phone %D 2022 %7 19.12.2022 %9 Review %J J Med Internet Res %G English %X Background: Most patients with cancer experience psychological or physical distress, which can adversely affect their quality of life (QOL). Smartphone app interventions are increasingly being used to improve QOL and psychological outcomes in patients with cancer. However, there is insufficient evidence regarding the effect of this type of intervention, with conflicting results in the literature. Objective: In this systematic review and meta-analysis, we investigated the effectiveness of mobile phone app interventions on QOL and psychological outcomes in adult patients with cancer, with a special focus on intervention duration, type of cancer, intervention theory, treatment strategy, and intervention delivery format. Methods: We conducted a literature search of PubMed, Web of Science, the Cochrane Library, Embase, Scopus, China National Knowledge Infrastructure, and WanFang to identify studies involving apps that focused on cancer survivors and QOL or psychological symptoms published from inception to October 30, 2022. We selected only randomized controlled trials that met the inclusion criteria and performed systematic review and meta-analysis. The standardized mean difference (SMD) with a 95% CI was pooled when needed. Sensitivity and subgroup analyses were also conducted. Results: In total, 30 randomized controlled trials with a total of 5353 participants were included in this meta-analysis. Compared with routine care, app interventions might improve QOL (SMD=0.39, 95% CI 0.27-0.51; P<.001); enhance self-efficacy (SMD=0.15, 95% CI 0.02-0.29; P=.03); and alleviate anxiety (SMD=−0.64, 95% CI −0.73 to −0.56; P<.001), depression (SMD=−0.33, 95% CI −0.58 to −0.08; P=.009), and distress (SMD=−0.34, 95% CI −0.61 to −0.08; P=.01). Short-term (duration of ≤3 months), physician-patient interaction (2-way communication using a smartphone app), and cognitive behavioral therapy interventions might be the most effective for improving QOL and alleviating adverse psychological effects. Conclusions: Our study showed that interventions using mobile health apps might improve QOL and self-efficacy as well as alleviate anxiety, depression, and distress in adult cancer survivors. However, these results should be interpreted with caution because of the heterogeneity of the interventions and the study design. More rigorous trials are warranted to confirm the suitable duration and validate the different intervention theories as well as address methodological flaws in previous studies. Trial Registration: PROSPERO CRD42022370599; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=370599 %M 36534460 %R 10.2196/39799 %U https://www.jmir.org/2022/12/e39799 %U https://doi.org/10.2196/39799 %U http://www.ncbi.nlm.nih.gov/pubmed/36534460 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 12 %P e42051 %T Assessing and Promoting Cardiovascular Health for Adolescent Women: User-Centered Design Approach %A Bradley,Kolbi %A Arconada Alvarez,Santiago J %A Gilmore,Amanda K %A Greenleaf,Morgan %A Herbert,Aayahna %A Kottke,Melissa J %A Parsell,Maren %A Patterson,Sierra %A Smith,Tymirra %A Sotos-Prieto,Mercedes %A Zeichner,Elizabeth %A Gooding,Holly C %+ Department of Pediatrics, Emory University School of Medicine, 49 Jesse Hill Jr Dr SE, Atlanta, GA, 30303, United States, 1 4047781429, holly.gooding@emory.edu %K adolescent %K heart disease %K mHealth %K digital health intervention %K user-centered design %K cardiovascular disease %K CVD %K women's health %K risk assessment %K young adults %K assessment tool %D 2022 %7 19.12.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Cardiovascular disease (CVD) is the leading cause of death among women in the United States. A considerable number of young women already have risk factors for CVD. Awareness of CVD and its risk factors is critical to preventing CVD, yet younger women are less aware of CVD prevalence, its risk factors, and preventative behaviors compared to older women. Objective: The purpose of this study is to assess CVD awareness among adolescent and young adult women and develop a lifestyle-based cardiovascular risk assessment tool for the promotion of CVD awareness among this population. Methods: This study used a 3-phase iterative design process with young women and health care practitioners from primary care and reproductive care clinics in Atlanta, Georgia. In phase 1, we administered a modified version of the American Heart Association Women’s Health Survey to young women, aged 15-24 years (n=67), to assess their general CVD awareness. In phase 2, we interviewed young women, aged 13-21 years (n=10), and their health care practitioners (n=10), to solicit suggestions for adapting the Healthy Heart Score, an existing adult cardiovascular risk assessment tool, for use with this age group. We also aimed to learn more about the barriers and challenges to health behavior change within this population and the clinical practices that serve them. In phase 3, we used the findings from the first 2 phases to create a prototype of a new online cardiovascular risk assessment tool designed specifically for young women. We then used an iterative user-centered design process to collect feedback from approximately 105 young women, aged 13-21 years, as we adapted the tool. Results: Only 10.5% (7/67) of the young women surveyed correctly identified CVD as the leading cause of death among women in the United States. Few respondents reported having discussed their personal risk (4/67, 6%) or family history of CVD (8/67, 11.9%) with a health care provider. During the interviews, young women reported better CVD awareness and knowledge after completing the adult risk assessment tool and suggested making the tool more teen-friendly by incorporating relevant foods and activity options. Health care practitioners emphasized shortening the assessment for easier use within practice and discussed other barriers adolescents may face in adopting heart-healthy behaviors. The result of the iterative design process was a youth-friendly prototype of a cardiovascular risk assessment tool. Conclusions: Adolescent and young adult women demonstrate low awareness of CVD. This study illustrates the potential value of a cardiovascular risk assessment tool adapted for use with young women and showcases the importance of user-centered design when creating digital health interventions. %M 36534450 %R 10.2196/42051 %U https://formative.jmir.org/2022/12/e42051 %U https://doi.org/10.2196/42051 %U http://www.ncbi.nlm.nih.gov/pubmed/36534450 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 12 %P e40730 %T Avoiding Under- and Overrecruitment in Behavioral Intervention Trials Using Bayesian Sequential Designs: Tutorial %A Bendtsen,Marcus %+ Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, 581 83, Sweden, 46 13 28 10 00, marcus.bendtsen@liu.se %K digital alcohol intervention %K Bayesian sequential design %K sample size %K randomized controlled trial %K trial recruitment %K behavioural intervention %K participant recruitment %K research participants %K research methods %K effect size %K trial procedure %D 2022 %7 16.12.2022 %9 Tutorial %J J Med Internet Res %G English %X Reducing research waste and protecting research participants from unnecessary harm should be top priorities for researchers studying interventions. However, the traditional use of fixed sample sizes exposes trials to risks of under- and overrecruitment by requiring that effect sizes be determined a priori. One mitigating approach is to adopt a Bayesian sequential design, which enables evaluation of the available evidence continuously over the trial period to decide when to stop recruitment. Target criteria are defined, which encode researchers’ intentions for what is considered findings of interest, and the trial is stopped once the scientific question is sufficiently addressed. In this tutorial, we revisit a trial of a digital alcohol intervention that used a fixed sample size of 2129 participants. We show that had a Bayesian sequential design been used, the trial could have ended after collecting data from approximately 300 participants. This would have meant exposing far fewer individuals to trial procedures, including being allocated to the waiting list control condition, and the evidence from the trial could have been made public sooner. %M 36525297 %R 10.2196/40730 %U https://www.jmir.org/2022/12/e40730 %U https://doi.org/10.2196/40730 %U http://www.ncbi.nlm.nih.gov/pubmed/36525297 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 12 %P e40382 %T A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and Persistence With Inflammatory Bowel Disease Therapy (ASSIST Study): Protocol for a Randomized Controlled Trial %A Axelrad,Jordan %A Long,Millie %A Horst,Sara %A Afzali,Anita %A Sapir,Tamar %A Fajardo,Kristina %A De Felice,Kara %A Sandler,Robert %A Cross,Raymond %+ Division of Gastroenterology, Department of Medicine, NYU Grossman School of Medicine, Inflammatory Bowel Disease Center at NYU Langone Health, 305 East 33rd Street, New York, NY, 10016, United States, 1 (212) 263 5290, Jordan.Axelrad@nyulangone.org %K remote therapy monitoring %K connected health %K patient engagement %K Crohn disease %K ulcerative colitis %K inflammatory bowel disease %K mobile phone %D 2022 %7 15.12.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Inflammatory bowel diseases (IBDs) are chronic inflammatory conditions of the gastrointestinal tract. Although adherence to IBD therapies is associated with improved clinical outcomes, overall adherence is poor. Consequently, there is a critical need to develop interventions that monitor adherence in real time and identify reasons for nonadherence to support clinical teams in initiating effective interventions. Recently, electronic- and web-based platforms have been developed to monitor adherence and guide interventions. A novel remote therapy monitoring (RTM) technology, the Tappt digital health system, has been developed to monitor real-time medication adherence patterns through smart label technologies, capture patient-reported outcomes and barriers to care, and process patient data through algorithms that trigger personalized digital and human touch points between clinical visits. Such a digital health solution enables care teams to proactively identify and mitigate nonadherence and worsening clinical outcomes. Objective: We propose a 12-month multicenter randomized controlled trial to assess the effectiveness of the Tappt digital health system on adherence, clinical outcomes, and health care use among patients diagnosed with IBD starting a new oral or subcutaneous therapy. Methods: The digital health system intervention will provide automatic measurement of medication adherence via smart labels for pill bottles or injectors as well as a monitoring platform for providers. The system will prompt patients to complete a two-item assessment of symptoms monthly using the PRO-2 scales for UC and Crohn disease, from which increased symptoms will be alerted to providers. Participants will be randomized 2:1 to the intervention group or the control group, which will receive standard of care. All participants are required to complete questionnaires at baseline as well as at 12, 26, and 52 weeks. Assuming an adherence rate of 0.65 and 0.9 among control and intervention participants, respectively, we will need to enroll 123 participants: 82 (66.7%) in the intervention group and 41 (33.3%) controls. We will compare adherence as measured by the medication possession ratio, defined as the number of days of supply of medication obtained during the observation period out of the total number of days in the observation period, in participants using the RTM versus those receiving standard of care. We will also compare clinical outcomes and health care use in participants using the RTM versus those receiving standard of care. Results: We anticipate starting recruitment in December 2022. Conclusions: Effective medication adherence monitoring and intervention programs need to be cost-efficient, pose little or no burden to the patient, record reliable data in real time, and provide actionable insights to the health care team. We anticipate the Tappt digital health system to improve the medication possession ratio, clinical outcomes, and health care use compared with standard of care. Trial Registration: ClinicalTrials.gov NCT05316584; https://clinicaltrials.gov/ct2/show/NCT05316584 International Registered Report Identifier (IRRID): PRR1-10.2196/40382 %M 36520519 %R 10.2196/40382 %U https://www.researchprotocols.org/2022/12/e40382 %U https://doi.org/10.2196/40382 %U http://www.ncbi.nlm.nih.gov/pubmed/36520519 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 12 %P e40892 %T Challenges in Recruiting University Students for Web-Based Indicated Prevention of Depression and Anxiety: Results From a Randomized Controlled Trial (ICare Prevent) %A Bolinski,Felix %A Kleiboer,Annet %A Neijenhuijs,Koen %A Karyotaki,Eirini %A Wiers,Reinout %A de Koning,Lisa %A Jacobi,Corinna %A Zarski,Anna-Carlotta %A Weisel,Kiona K %A Cuijpers,Pim %A Riper,Heleen %+ Department of Clinical, Neuro, and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, De Boelelaan 1105, Amsterdam, 1081HV, Netherlands, 31 0205985204, f.bolinski@vu.nl %K digital mental health %K students %K indicated prevention %K recruitment %K randomized trial %K mobile phone %D 2022 %7 14.12.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression and anxiety are common mental health conditions in college and university student populations. Offering transdiagnostic, web-based prevention programs such as ICare Prevent to those with subclinical complaints has the potential to reduce some barriers to receiving help (eg, availability of services, privacy considerations, and students’ desire for autonomy). However, uptake of these interventions is often low, and accounts of recruitment challenges are needed to complement available effectiveness research in student populations. Objective: The aims of this study were to describe recruitment challenges together with effective recruitment strategies for ICare Prevent and provide basic information on the intervention’s effectiveness. Methods: A 3-arm randomized controlled trial was conducted in a student sample with subclinical symptoms of depression and anxiety on the effectiveness of an individually guided (human support and feedback on exercises provided after each session, tailored to each participant) and automatically guided (computer-generated messages provided after each session, geared toward motivation) version of ICare Prevent, a web-based intervention with transdiagnostic components for the indicated prevention of depression and anxiety. The intervention was compared with care as usual. Descriptive statistics were used to outline recruitment challenges and effective web-based and offline strategies as well as students’ use of the intervention. A basic analysis of intervention effects was conducted using a Bayesian linear mixed model, with Bayes factors reported as the effect size. Results: Direct recruitment through students’ email addresses via the central student administration was the most effective strategy. Data from 35 participants were analyzed (individually guided: n=14, 40%; automatically guided: n=8, 23%; care as usual: n=13, 37%). Use of the intervention was low, with an average of 3 out of 7 sessions (SD 2.9) completed. The analyses did not suggest any intervention effects other than anecdotal evidence (all Bayes factors10≤2.7). Conclusions: This report adds to the existing literature on recruitment challenges specific to the student population. Testing the feasibility of recruitment measures and the greater involvement of the target population in their design, as well as shifting from direct to indirect prevention, can potentially help future studies in the field. In addition, this report demonstrates an alternative basic analytical strategy for underpowered randomized controlled trials. Trial Registration: International Clinical Trials Registry Platform NTR6562; https://tinyurl.com/4rbexzrk International Registered Report Identifier (IRRID): RR2-10.1186/s13063-018-2477-y %M 36515986 %R 10.2196/40892 %U https://www.jmir.org/2022/12/e40892 %U https://doi.org/10.2196/40892 %U http://www.ncbi.nlm.nih.gov/pubmed/36515986 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 12 %P e40723 %T Efficacy of the Mental Health App Intellect to Reduce Stress: Randomized Controlled Trial With a 1-Month Follow-up %A Toh,Sean Han Yang %A Tan,Jessalin Hui Yan %A Kosasih,Feodora Roxanne %A Sündermann,Oliver %+ Intellect Pte Ltd, 171 Tras St, #02-179 Union Building, Singapore, S079025, Singapore, 65 93571995, oliver@intellect.co %K mobile health %K mHealth %K randomized controlled trial %K RCT %K self-guided interventions %K cognitive behavioral therapy %K CBT %K stress coping %K stress management %K university students %K psychological mindedness %K coping self-efficacy %K mobile phone %D 2022 %7 14.12.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Excessive stress is a major global health concern, particularly in young adults. Short skills-focused self-guided interventions (SGIs) on smartphones are a scalable way to improve stress-coping skills at the population level. Objective: In this randomized controlled trial, we aimed to examine the possible efficacy of a recently developed stress-coping SGI (Intellect) in improving psychological distress, relative to an active control group and 2 potential moderators of this predicted relationship (ie, psychological mindedness [PM] and coping self-efficacy [CSE]). Methods: University students (N=321) were randomly assigned to either an 8-day SGI on stress-coping or an active control group. Self-reported measures were obtained at baseline, after the intervention, and at the 1-month follow-up. The primary outcome was psychological stress (Psychological Stress Measure-9). Secondary outcomes were anxiety (Generalized Anxiety Disorder-7) and depressive symptoms (Patient Health Questionnaire-9). PM and CSE were assessed as potential moderators at baseline. Results: The final sample (n=264) included 188 (71.2%) female, 66 (25%) male, 7 (2.7%) nonbinary, and 3 (1.1%) others participants with a mean age of 22.5 (SD 5.41) years. The intervention group reported significantly lower perceived stress (partial eta–squared [ηp2]=0.018; P=.03) and anxiety (ηp2=0.019; P=.03) levels after intervention relative to the active control group. The effects on perceived stress levels remained statistically significant at the 1-month follow-up (ηp2=0.015; P=.05). Students with the lowest CSE and highest PM experienced the fastest decline in perceived stress levels (β=6.37, 95% Cl 2.98-9.75). Improvements in anxiety levels were not observed at 1-month follow-up. Similarly, no intervention effects were found for depression levels at postintervention and follow-up periods. Conclusions: This study provides evidence that the Intellect stress-coping SGI is effective in reducing perceived stress and anxiety levels among university students. Mobile health apps are brief, scalable, and can make important contributions to public mental health. Trial Registration: ClinicalTrials.gov NCT04978896; https://www.clinicaltrials.gov/ct2/show/NCT04978896 %M 36515984 %R 10.2196/40723 %U https://formative.jmir.org/2022/12/e40723 %U https://doi.org/10.2196/40723 %U http://www.ncbi.nlm.nih.gov/pubmed/36515984 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 12 %P e42191 %T Detailed Versus Simplified Dietary Self-monitoring in a Digital Weight Loss Intervention Among Racial and Ethnic Minority Adults: Fully Remote, Randomized Pilot Study %A Patel,Michele L %A Cleare,Angel E %A Smith,Carly M %A Rosas,Lisa Goldman %A King,Abby C %+ Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, 3180 Porter Drive, Palo Alto, CA, 94304, United States, 1 650 549 7047, michele.patel@stanford.edu %K weight loss %K obesity %K behavioral intervention %K self-monitoring %K race %K ethnicity %K digital health %K diet tracking %K engagement %K randomized controlled trial %K RCT %K mobile phone %D 2022 %7 13.12.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Detailed self-monitoring (or tracking) of dietary intake is a popular and effective weight loss approach that can be delivered via digital tools, although engagement declines over time. Simplifying the experience of self-monitoring diet may counteract this decline in engagement. Testing these strategies among racial and ethnic minority groups is important as these groups are often disproportionately affected by obesity yet underrepresented in behavioral obesity treatment. Objective: In this 2-arm pilot study, we aimed to evaluate the feasibility and acceptability of a digital weight loss intervention with either detailed or simplified dietary self-monitoring. Methods: We recruited racial and ethnic minority adults aged ≥21 years with a BMI of 25 kg/m2 to 45 kg/m2 and living in the United States. The Pacific time zone was selected for a fully remote study. Participants received a 3-month stand-alone digital weight loss intervention and were randomized 1:1 to either the detailed arm that was instructed to self-monitor all foods and drinks consumed each day using the Fitbit mobile app or to the simplified arm that was instructed to self-monitor only red zone foods (foods that are highly caloric and of limited nutritional value) each day via a web-based checklist. All participants were instructed to self-monitor both steps and body weight daily. Each week, participants were emailed behavioral lessons, action plans, and personalized feedback. In total, 12 a priori benchmarks were set to establish feasibility, including outcomes related to reach, retention, and self-monitoring engagement (assessed objectively via digital tools). Acceptability was assessed using a questionnaire. Weight change was assessed using scales shipped to the participants’ homes and reported descriptively. Results: The eligibility screen was completed by 248 individuals, of whom 38 (15.3%) were randomized, 18 to detailed and 20 to simplified. At baseline, participants had a mean age of 47.4 (SD 14.0) years and BMI of 31.2 (SD 4.8) kg/m2. More than half (22/38, 58%) were identified as Hispanic of any race. The study retention rate was 92% (35/38) at 3 months. The detailed arm met 9 of 12 feasibility benchmarks, while the simplified arm met all 12. Self-monitoring engagement was moderate to high (self-monitoring diet: median of 49% of days for detailed, 97% for simplified; self-monitoring steps: 99% for detailed, 100% for simplified; self-monitoring weight: 67% for detailed, 80% for simplified). Participants in both arms reported high satisfaction, with 89% indicating that they would recommend the intervention. Weight change was −3.4 (95% CI −4.6 to −2.2) kg for detailed and −3.3 (95% CI −4.4 to −2.2) kg for simplified. Conclusions: A digital weight loss intervention that incorporated either detailed or simplified dietary self-monitoring was feasible, with high retention and engagement, and acceptable to racial and ethnic minority adults. Trial Registration: ASPREDICTED #66674; https://aspredicted.org/ka478.pdf %M 36512404 %R 10.2196/42191 %U https://formative.jmir.org/2022/12/e42191 %U https://doi.org/10.2196/42191 %U http://www.ncbi.nlm.nih.gov/pubmed/36512404 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 12 %P e37389 %T Evaluation of OPTIMISE (Online Programme to Tackle Individual’s Meat Intake Through Self-regulation): Cohort Study %A Stewart,Cristina %A Piernas,Carmen %A Frie,Kerstin %A Cook,Brian %A Jebb,Susan A %+ Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, United Kingdom, 44 01865 617826, susan.jebb@phc.ox.ac.uk %K self-regulation %K self-monitoring %K goal setting %K meat intake %K meat reduction %K multi-component intervention %K health %K nutrition %K diet %D 2022 %7 12.12.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: There is an urgent need to reduce society’s meat consumption to help mitigate climate change and reduce noncommunicable diseases. Objective: This study aimed to investigate changes in meat intake after participation in an online, multicomponent, self-regulation intervention. Methods: We conducted a pre-post observational study among adult meat eaters in the United Kingdom who signed up to a website offering support based on self-regulation theory to reduce meat consumption. The program lasted 9 weeks (including a 1-week baseline phase, a 4-week active intervention phase, and a 4-week maintenance phase), comprising self-monitoring, goal setting, action planning, and health and environmental feedback. Meat intake was estimated during weeks 1, 5, and 9 using a 7-day meat frequency questionnaire. We analyzed the change in mean daily meat intake from baseline to week 5 and week 9 among those reporting data using a hierarchical linear mixed model. We assessed changes in attitudes toward meat consumption by questionnaire and considered the acceptability and feasibility of the intervention. Results: The baseline cohort consisted of 289 participants, of whom 77 were analyzed at week 5 (26.6% of the baseline sample) and 55 at week 9 (71.4% of the week 5 sample). We observed large reductions in meat intake at 5 and 9 weeks: –57 (95% CI –70 to –43) g/day (P<.001) and –49 (95% CI –64 to –34) g/day (P<.001), respectively. Participants’ meat-free self-efficacy increased, meat-eating identities moved toward reduced-meat and non–meat-eating identities, and perceptions of meat consumption as the social norm reduced. Participants who completed the study reported high engagement and satisfaction with the intervention. Conclusions: Among people motivated to engage, this online self-regulation program may lead to large reductions in meat intake for more than 2 months, with promising signs of a change in meat-eating identity toward more plant-based diets. This digital behavior change intervention could be offered to complement population-level interventions to support reduction of meat consumption. %M 36508245 %R 10.2196/37389 %U https://www.jmir.org/2022/12/e37389 %U https://doi.org/10.2196/37389 %U http://www.ncbi.nlm.nih.gov/pubmed/36508245 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 12 %P e38049 %T The Effectiveness of Internet-Guided Self-help Interventions to Promote Physical Activity Among Individuals With Depression: Systematic Review %A Tang,Yiling %A Gierc,Madelaine %A Lam,Raymond W %A Liu,Sam %A Faulkner,Guy %+ School of Kinesiology, University of British Columbia, 6081 University Blvd, Vancouver, BC, V6T 1Z1, Canada, 1 6048222211, yilingtt@student.ubc.ca %K physical activity %K eHealth %K mobile health %K mHealth %K depression %K systematic review %K internet %K mobile phone %D 2022 %7 12.12.2022 %9 Review %J JMIR Ment Health %G English %X Background: Depression is a prevalent and debilitating mental disorder and a leading cause of disability worldwide. Physical activity (PA) interventions have been shown to alleviate depressive symptoms. However, not all patients have access to PA programing tailored for depression. Internet-guided self-help (IGSH) interventions may be an effective option for increasing PA among people with depression who cannot or prefer not to access supervised exercise treatment. Objective: We aimed to evaluate the effectiveness of IGSH interventions in increasing PA and alleviating depressive symptoms in people with depression. Methods: A systematic literature search was conducted for randomized controlled trials and quasiexperimental studies using 9 electronic databases. The review was registered in PROSPERO (2020 CRD42020221713). Results: A total of 4 randomized controlled trials (430 participants) met the inclusion criteria. Of these, 3 were web-based and 1 was app-based. Three studies found IGSH interventions to have medium to large effects on decreasing depressive symptoms but not on increasing PA compared with waitlist or usual care. One study showed increased self-reported PA but no significant difference in depressive symptoms in the intervention group compared with the control group. Goal setting was the most common behavior change technique used in the interventions. Dropout rates within the intervention groups were relatively low (0%-19%). Conclusions: Our findings suggested that IGSH PA interventions are feasible and have the potential to reduce depressive symptoms in people with depression. More well-designed and tailored interventions with different combinations of behavior change techniques, particularly those targeting the emotion domain, are needed to assess the overall effectiveness and feasibility of using IGSH interventions to increase PA among people with depression. Trial Registration: PROSPERO CRD42020221713; https://tinyurl.com/ysaua5bu %M 36508243 %R 10.2196/38049 %U https://mental.jmir.org/2022/12/e38049 %U https://doi.org/10.2196/38049 %U http://www.ncbi.nlm.nih.gov/pubmed/36508243 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 12 %P e42397 %T Dropout Rate in Digital Health Interventions for the Prevention of Skin Cancer: Systematic Review, Meta-analysis, and Metaregression %A Hernández-Rodríguez,Juan-Carlos %A García-Muñoz,Cristina %A Ortiz-Álvarez,Juan %A Saigí-Rubió,Francesc %A Conejo-Mir,Julián %A Pereyra-Rodriguez,Jose-Juan %+ Department of Nursing and Physical Therapy, University of Cadiz, Avda. Ana de Viya 52, Cadiz, 11009, Spain, 34 956 01 90 00, ccriss.g@gmail.com %K skin cancer %K digital health %K dropout %K prevention %K systematic review %K meta-analysis %K meta analyses %K review methodology %K cancer %K skin %K dermatology %K attrition %K digital intervention %K digital treatment %K eHealth %K randomized controlled trial %K RCT %D 2022 %7 9.12.2022 %9 Review %J J Med Internet Res %G English %X Background: Digital strategies are innovative approaches to the prevention of skin cancer, but the attrition following this kind of intervention needs to be analyzed. Objective: The aim of this paper is to assess the dropouts from studies focused on digital strategies for the prevention of skin cancer. Methods: We conducted this systematic review with meta-analyses and metaregression according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statements. Search terms for skin cancer, digital strategies, and prevention were combined to search PubMed, Scopus, Web of Science, CINAHL, and Cochrane Library from inception until July 2022. Randomized clinical trials that reported dropouts of participants and compared digital strategies with other interventions to prevent skin cancer in healthy or disease-free participants were included. Two independent reviewers extracted data for analysis. The Revised Cochrane Collaboration Bias tool was employed. We calculated the pooled dropout rate of participants through a meta-analysis of proportions and examined whether dropout was more or less frequent in digital interventions against comparators via an odds ratio (OR) meta-analysis. Data were pooled using a random-effects model. Subgroup meta-analyses were conducted in a meta-analysis of proportions and OR meta-analysis to assess the dropout events when data were sorted by digital interventions or control comparator. A univariate metaregression based on a random-effects model assessed possible moderators of dropout. Participants’ dropout rates as pooled proportions were calculated for all groups combined, and the digital and comparator groups separately. OR>1 indicated higher dropouts for digital-based interventions. Metaregressions were performed for age, sex, length of intervention, and sample size. Results: A total of 17 studies were included. The overall pooled dropout rate was 9.5% (95% CI 5.0-17.5). The subgroup meta-analysis of proportions revealed a dropout rate of 11.6% for digital strategies (95% CI 6.8-19.0) and 10.0% for comparators (95% CI 5.5-17.7). A trend of higher dropout rates for digital strategies was observed in the overall (OR 1.16, 95% CI 0.98-1.36) and subgroup OR meta-analysis, but no significant differences were found between the groups. None of the covariates moderated the effect size in the univariate metaregression. Conclusions: Digital strategies had a higher dropout rate compared to other prevention interventions, but the difference was not significant. Standardization is needed regarding reporting the number of and reasons for dropouts. Trial Registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42022329669; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=329669 %M 36485027 %R 10.2196/42397 %U https://www.jmir.org/2022/12/e42397 %U https://doi.org/10.2196/42397 %U http://www.ncbi.nlm.nih.gov/pubmed/36485027 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 12 %P e39727 %T Efficacy of Internet-Based Acceptance and Commitment Therapy for Depressive Symptoms, Anxiety, Stress, Psychological Distress, and Quality of Life: Systematic Review and Meta-analysis %A Han,Areum %A Kim,Tae Hui %+ Department of Psychiatry, Yonsei Wonju Medical College, Ilsan-ro 20, Wonju, 26426, Republic of Korea, 82 337410534, gooddr@yonsei.ac.kr %K acceptance and commitment therapy %K anxiety %K depression %K internet-based intervention %K meta-analysis %K psychological distress %K quality of life %K stress %K systematic review %D 2022 %7 9.12.2022 %9 Review %J J Med Internet Res %G English %X Background: Acceptance and commitment therapy (ACT) is an empirically supported transdiagnostic approach that involves mindfulness processes and behavior change processes for valued living. Objective: This systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to assess the efficacy of internet-based ACT (iACT) for depressive symptoms, anxiety, stress, psychological distress, and quality of life (QoL). Methods: PubMed, CINAHL, PsycINFO, and SCOPUS databases were searched to identify relevant RCTs published up to June 5, 2021. The included RCTs were assessed using the Cochrane Collaboration risk-of-bias tool. The use of either a random effects model or fixed effects model was determined using I2 statistic values for heterogeneity. Subgroup analyses were conducted according to the type of control group, the use of therapist guidance, delivery modes, and the use of targeted participants, when applicable. Results: A total of 39 RCTs met the inclusion criteria. Meta-analyses found small effects of iACT on depressive symptoms, anxiety, stress, psychological distress, and QoL at the immediate posttest and follow-up. There was no significant effect of iACT on stress at follow-up. Subgroup analyses showed small to medium effects of iACT on all the outcomes at the immediate posttest and follow-up compared with the passive control groups. In contrast, subgroup analyses that compared iACT with active control groups found no differences between groups on stress, psychological distress, and QoL at the immediate posttest or on depressive symptoms, anxiety, and stress at follow-up. In addition, subgroup analyses conducted according to the use of therapist guidance, delivery modes, and the use of targeted participants found no statistically significant subgroup differences among studies in all the outcomes, except for the subgroup difference among studies according to the use of targeted participants for depressive symptoms at the immediate posttest (ie, a statistically significant, larger effect of iACT when studies targeted people with depressive symptoms). The overall risk of bias across the studies was unclear. Conclusions: The findings of this study contribute to the body of evidence regarding the effects of iACT on depressive symptoms, anxiety, stress, psychological distress, and QoL and may be applicable in any population, as ACT is a transdiagnostic approach. Few studies have compared iACT with active control conditions, especially for stress and psychological distress at the immediate posttest and follow-up. In addition, the active control conditions varied among the included studies. Further high-quality studies are needed to better understand whether iACT is comparable or superior to other evidence-based interventions, such as cognitive behavioral therapy, in decreasing depressive symptoms, anxiety, stress, and psychological distress and improving QoL. %M 36485030 %R 10.2196/39727 %U https://www.jmir.org/2022/12/e39727 %U https://doi.org/10.2196/39727 %U http://www.ncbi.nlm.nih.gov/pubmed/36485030 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 12 %P e39483 %T Changes in a Digital Type 2 Diabetes Self-management Intervention During National Rollout: Mixed Methods Study of Fidelity %A Benton,Jack S %A Cotterill,Sarah %A Hawkes,Rhiannon E %A Miles,Lisa M %A French,David P %+ Manchester Centre for Health Psychology, Division of Psychology and Mental Health, University of Manchester, Coupland 1 Building, Oxford Road, Manchester, M13 9PL, United Kingdom, 44 7853986479, jack.benton@manchester.ac.uk %K type 2 diabetes %K Healthy Living %K digital interventions %K behavior change %K self-management %K fidelity %K implementation %K mixed methods %K mobile phone %D 2022 %7 7.12.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: “Healthy Living for People with type 2 Diabetes (HeLP-Diabetes)” was a theory-based digital self-management intervention for people with type 2 diabetes mellitus that encouraged behavior change using behavior change techniques (BCTs) and promoted self-management. HeLP-Diabetes was effective in reducing HbA1c levels in a randomized controlled trial (RCT). National Health Service (NHS) England commissioned a national rollout of HeLP-Diabetes in routine care (now called “Healthy Living”). Healthy Living presents a unique opportunity to examine the fidelity of the national rollout of an intervention originally tested in an RCT. Objective: This research aimed to describe the Healthy Living BCT and self-management content and features of intervention delivery, compare the fidelity of Healthy Living with the original HeLP-Diabetes intervention, and explain the reasons for any fidelity drift during national rollout through qualitative interviews. Methods: Content analysis of Healthy Living was conducted using 3 coding frameworks (objective 1): the BCT Taxonomy v1, a new coding framework for assessing self-management tasks, and the Template for Intervention Description and Replication. The extent to which BCTs and self-management tasks were included in Healthy Living was compared with published descriptions of HeLP-Diabetes (objective 2). Semistructured interviews were conducted with 9 stakeholders involved in the development of HeLP-Diabetes or Healthy Living to understand the reasons for any changes during national rollout (objective 3). Qualitative data were thematically analyzed using a modified framework approach. Results: The content analysis identified 43 BCTs in Healthy Living. Healthy Living included all but one of the self-regulatory BCTs (“commitment”) in the original HeLP-Diabetes intervention. Healthy Living was found to address all areas of self-management (medical, emotional, and role) in line with the original HeLP-Diabetes intervention. However, 2 important changes were identified. First, facilitated access by a health care professional was not implemented; interviews revealed this was because general practices had fewer resources in comparison with the RCT. Second, Healthy Living included an additional structured web-based learning curriculum that was developed by the HeLP-Diabetes team but was not included in the original RCT; interviews revealed that this was because of changes in NHS policy that encouraged referral to structured education. Interviewees described how the service provider had to reformat the content of the original HeLP-Diabetes website to make it more usable and accessible to meet the multiple digital standards required for implementation in the NHS. Conclusions: The national rollout of Healthy Living had good fidelity to the BCT and self-management content of HeLP-Diabetes. Important changes were attributable to the challenges of scaling up a digital intervention from an RCT to a nationally implemented intervention, mainly because of fewer resources available in practice and the length of time since the RCT. This study highlights the importance of considering implementation throughout all phases of intervention development. %M 36476723 %R 10.2196/39483 %U https://www.jmir.org/2022/12/e39483 %U https://doi.org/10.2196/39483 %U http://www.ncbi.nlm.nih.gov/pubmed/36476723 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 5 %N 4 %P e38656 %T Lessons Learned From an Effectiveness Evaluation of Inlife, a Web-Based Social Support Intervention for Caregivers of People With Dementia: Randomized Controlled Trial %A Christie,Hannah Liane %A Dam,Alieske Elisabeth Henrike %A van Boxtel,Martin %A Köhler,Sebastian %A Verhey,Frans %A de Vugt,Marjolein Elisabeth %+ Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, Postbus 616, Maastricht, 6200 MD, Netherlands, 31 456213078, hannah.christie@maastrichtuniversity.nl %K dementia %K Alzheimer's %K neurodegenerative %K caregiver %K caregiving %K digital health %K eHealth %K mHealth %K Information communication technology %K RCT %K randomized controlled trial %K social support %K support platform %K online platform %K web-based %K internet-based %K peer-support %K informal support %K social interaction %K support network %D 2022 %7 7.12.2022 %9 Original Paper %J JMIR Aging %G English %X Background: Informal care for people with dementia not only affects the well-being of the primary caregiver but also changes their roles and interactions with the social environment. New online interventions might facilitate access to social support. Recently, an online social support platform, Inlife, was developed in the Netherlands and aims to enhance social support and positive interactions in informal support networks. Objective: This study aimed to evaluate the effectiveness of Inlife for caregivers of people with dementia. Methods: A randomized controlled trial with 96 caregivers of people with dementia was performed. Participants were randomly assigned to the Inlife intervention or the waiting list control group. After 16 weeks of Inlife use, the waiting list control group could start using Inlife. Effects were evaluated at baseline (T0), 8 weeks (T1), and 16 weeks (T2). The 16-week follow-up assessment (T2) served as the primary endpoint to evaluate the results for the primary and secondary outcome variables evaluated with online self-report questionnaires. The primary outcomes included feelings of caregiver competence and perceived social support. The secondary outcomes included received support, feelings of loneliness, psychological complaints (eg, anxiety, stress), and quality of life. Results: No significant improvements were demonstrated for the intervention group (n=48) relative to the control group (n=48) for the primary outcomes (feeling of carer competence: b=–0.057, 95% CI –0.715 to 0.602, P=.87; perceived social support: b=–15.877, 95% CI –78.284 to 46.530, P=.62) or any secondary outcome. This contrasts with our qualitative findings showing the potential of Inlife to facilitate the care process in daily life. Adherence was not optimal for all Inlife users. Additional per-protocol and sensitivity analyses also revealed no beneficial results for high active Inlife users or specific subgroups. Inlife users were more active when part of a larger network. Conclusions: Researchers should be modest regarding the effectiveness of online caregiver interventions in terms of quantitative measures of well-being and quality of life. Nevertheless, online tools have the potential to facilitate the caregiver process in daily life. Lessons learned include the importance of harnessing the power of human interaction in eHealth, making use of the user’s social capital, and the need to develop research methods that can identify benefits in daily life that are ecologically valid for caregivers. Trial Registration: Netherlands Trial Register NTR6131; https://trialsearch.who.int/Trial2.aspx?TrialID=NTR6131 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-017-2097-y %M 36476485 %R 10.2196/38656 %U https://aging.jmir.org/2022/4/e38656 %U https://doi.org/10.2196/38656 %U http://www.ncbi.nlm.nih.gov/pubmed/36476485 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 12 %P e40278 %T Changes in Glycemic Control Following Use of a Spanish-Language, Culturally Adapted Diabetes Program: Retrospective Study %A Edwards,Caitlyn %A Orellana,Elisa %A Rawlings,Kelly %A Rodriguez-Pla,Mirta %A Venkatesan,Aarathi %+ Vida Health, 100 Montgomery St, Ste 750, San Francisco, CA, 94104, United States, 1 415 989 1017, caitlyn.edwards@vida.com %K type 2 diabetes %K digital health %K diabetes intervention %K diabetes %K mobile health %K mhealth %K app-based %K health coaching %K HbA1c %K glycemic improvements %K localization %K Spanish %K health application %K health education %K patient education %K nutrition %K digital health intervention %K health management %D 2022 %7 7.12.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Several barriers to diabetes treatment and care exist, particularly in underserved medical communities. Objective: This study aimed to evaluate a novel, culturally adapted, Spanish-language mHealth diabetes program for glycemic control. Methods: Professional Spanish translators, linguists, and providers localized the entirety of the Vida Health Diabetes Management Program into a culturally relevant Spanish-language version. The Spanish-language Vida Health Diabetes Management Program was used by 182 (n=119 women) Spanish-speaking adults with diabetes. This app-based program provided access to culturally adapted educational content on diabetes self-management, one-on-one remote counseling and coaching sessions, and on-demand in-app messaging with bilingual (Spanish and English) certified health coaches, registered dietitian nutritionists, and certified diabetes care and education specialists. Hemoglobin A1c (HbA1c) was the primary outcome measure, and a 2-tailed, paired t test was used to evaluate changes in HbA1c before and after program use. To determine the relationship between program engagement and changes in glycemic control, a cluster-robust multiple regression analysis was employed. Results: We observed a significant decrease in HbA1c of –1.23 points between baseline (mean 9.65%, SD 1.56%) and follow-up (mean 8.42%, SD 1.44%; P<.001). Additionally, we observed a greater decrease in HbA1c among participants with high program engagement (high engagement: –1.59%, SD 1.97%; low engagement: –0.84%, SD 1.64%; P<.001). Conclusions: This work highlights improvements in glycemic control that were clinically as well as statistically significant among Spanish-preferring adults enrolled in the Vida Health Spanish Diabetes Management Program. Greater improvements in glycemic control were observed among participants with higher program engagement. These results provide needed support for the use of digital health interventions to promote meaningful improvements in glycemic control in a medically underserved community. %M 36476397 %R 10.2196/40278 %U https://formative.jmir.org/2022/12/e40278 %U https://doi.org/10.2196/40278 %U http://www.ncbi.nlm.nih.gov/pubmed/36476397 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 12 %P e39489 %T The Development of a Novel mHealth Tool for Obstructive Sleep Apnea: Tracking Continuous Positive Airway Pressure Adherence as a Percentage of Time in Bed %A Pfammatter,Angela Fidler %A Hughes,Bonnie Olivia %A Tucker,Becky %A Whitmore,Harry %A Spring,Bonnie %A Tasali,Esra %+ Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, 633 Clark St, Evanston, IL, 60208, United States, 1 847 491 3741, angela@northwestern.edu %K obstructive sleep apnea %K continuous positive airway pressure %K CPAP adherence %K weight loss %K lifestyle %D 2022 %7 5.12.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Continuous positive airway pressure (CPAP) is the mainstay obstructive sleep apnea (OSA) treatment; however, poor adherence to CPAP is common. Current guidelines specify 4 hours of CPAP use per night as a target to define adequate treatment adherence. However, effective OSA treatment requires CPAP use during the entire time spent in bed to optimally treat respiratory events and prevent adverse health effects associated with the time spent sleeping without wearing a CPAP device. Nightly sleep patterns vary considerably, making it necessary to measure CPAP adherence relative to the time spent in bed. Weight loss is an important goal for patients with OSA. Tools are required to address these clinical challenges in patients with OSA. Objective: This study aimed to develop a mobile health tool that combined weight loss features with novel CPAP adherence tracking (ie, percentage of CPAP wear time relative to objectively assessed time spent in bed) for patients with OSA. Methods: We used an iterative, user-centered process to design a new CPAP adherence tracking module that integrated with an existing weight loss app. A total of 37 patients with OSA aged 20 to 65 years were recruited. In phase 1, patients with OSA who were receiving CPAP treatment (n=7) tested the weight loss app to track nutrition, activity, and weight for 10 days. Participants completed a usability and acceptability survey. In phase 2, patients with OSA who were receiving CPAP treatment (n=21) completed a web-based survey about their interpretations and preferences for wireframes of the CPAP tracking module. In phase 3, patients with recently diagnosed OSA who were CPAP naive (n=9) were prescribed a CPAP device (ResMed AirSense10 AutoSet) and tested the integrated app for 3 to 4 weeks. Participants completed a usability survey and provided feedback. Results: During phase 1, participants found the app to be mostly easy to use, except for some difficulty searching for specific foods. All participants found the connected devices (Fitbit activity tracker and Fitbit Aria scale) easy to use and helpful. During phase 2, participants correctly interpreted CPAP adherence success, expressed as percentage of wear time relative to time spent in bed, and preferred seeing a clearly stated percentage goal (“Goal: 100%”). In phase 3, participants found the integrated app easy to use and requested push notification reminders to wear CPAP before bedtime and to sync Fitbit in the morning. Conclusions: We developed a mobile health tool that integrated a new CPAP adherence tracking module into an existing weight loss app. Novel features included addressing OSA-obesity comorbidity, CPAP adherence tracking via percentage of CPAP wear time relative to objectively assessed time spent in bed, and push notifications to foster adherence. Future research on the effectiveness of this tool in improving OSA treatment adherence is warranted. %M 36469406 %R 10.2196/39489 %U https://www.jmir.org/2022/12/e39489 %U https://doi.org/10.2196/39489 %U http://www.ncbi.nlm.nih.gov/pubmed/36469406 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 12 %P e38561 %T The Web-Based Advance Care Planning Program “Explore Your Preferences for Treatment and Care”: Development, Pilot Study, and Before-and-After Evaluation %A van der Smissen,Doris %A Rietjens,Judith A C %A van Dulmen,Sandra %A Drenthen,Ton %A Vrijaldenhoven-Haitsma,F Ragnhild M D %A Wulp,Marijke %A van der Heide,Agnes %A Korfage,Ida J %+ Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Doctor Molewaterplein 40, Rotterdam, 3015 GD, Netherlands, 31 107038470, d.vandersmissen@erasmusmc.nl %K advance care planning %K internet-based intervention %K decision aids %K patient education %K eHealth %K health communication %K patient-centered care %K chronic disease %D 2022 %7 2.12.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based advance care planning (ACP) programs may support patients in thinking about and discussing their preferences for future treatment and care. However, they are not widely available, and only a limited number of programs are evidence based. Objective: We aimed to develop and evaluate an evidence-based, interactive web-based ACP program that guides users through the process of thinking about, discussing, and recording of preferences for treatment and care. Methods: The program “Explore your preferences for treatment and care” was developed, pilot-tested on feasibility, and subsequently evaluated; engagement in ACP was assessed before program completion and 2 months after program completion using the ACP Engagement Survey (score 1-5) among 147 persons with chronic disease. Usability (score 0-100) and user satisfaction (score 1-5) were also assessed. Results: ACP engagement increased from 2.8 before program completion to 3.0 two months after program completion (P<.001); contemplation about ACP increased from 2.6 to 2.8 (P=.003), and readiness for ACP increased from 2.2 to 2.5 (P<.001). No changes were found for knowledge about ACP (3.0-3.2; P=.07) and self-efficacy for ACP (3.8-3.8; P=.25). The program was perceived as usable (mean 70, SD 13), attractive (mean 3.8, SD 0.7), and comprehensible (mean 4.2, SD 0.6). Conclusions: We developed an evidence-based, interactive web-based ACP program in cocreation with patients, relatives, and health care professionals. Before-and-after evaluation showed that the program can support people in taking first steps in ACP and in reflecting on preferences for treatment and care, by guiding them through the process of ACP using a stepwise approach. Participants perceived the program as usable and understandable, and they were satisfied with the program and with the amount of information. Health care professionals may use the program as a tool to start ACP discussions with their patients. The program may increase awareness of ACP. %M 36459410 %R 10.2196/38561 %U https://www.jmir.org/2022/12/e38561 %U https://doi.org/10.2196/38561 %U http://www.ncbi.nlm.nih.gov/pubmed/36459410 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 12 %P e39593 %T Effectiveness of mHealth Interventions in the Control of Lifestyle and Cardiovascular Risk Factors in Patients After a Coronary Event: Systematic Review and Meta-analysis %A Cruz-Cobo,Celia %A Bernal-Jiménez,María Ángeles %A Vázquez-García,Rafael %A Santi-Cano,María José %+ Faculty of Nursing and Physiotherapy, University of Cádiz, Av. Ana de Viya, 52, Cádiz, 11009, Spain, 34 956 019042 ext 9042, mariajose.santi@uca.es %K coronary disease %K acute coronary syndrome %K mobile health %K smartphone %K mobile apps %K mobile phone %D 2022 %7 2.12.2022 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Coronary artery disease is the main cause of death and loss of disability-adjusted life years worldwide. Information and communication technology has become an important part of health care systems, including the innovative cardiac rehabilitation services through mobile phone and mobile health (mHealth) interventions. Objective: In this study, we aimed to determine the effectiveness of different kinds of mHealth programs in changing lifestyle behavior, promoting adherence to treatment, and controlling modifiable cardiovascular risk factors and psychosocial outcomes in patients who have experienced a coronary event. Methods: A systematic review of the literature was performed following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. A thorough search of the following biomedical databases was conducted: PubMed, Embase, Web of Science, SciELO, CINAHL, Scopus, The Clinical Trial, and Cochrane. Articles that were randomized clinical trials that involved an intervention consisting of an mHealth program using a mobile app in patients after a coronary event were included. The articles analyzed some of the following variables as outcome variables: changes in lifestyle behavior, cardiovascular risk factors, and anthropometric and psychosocial variables. A meta-analysis of the variables studied was performed with the Cochrane tool. The risk of bias was assessed using the Cochrane Collaboration tool; the quality of the evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation tool; and heterogeneity was measured using the I2 test. Results: A total of 23 articles were included in the review, and 20 (87%) were included in the meta-analysis, with a total sample size of 4535 patients. Exercise capacity measured using the 6-minute walk test (mean difference=21.64, 95% CI 12.72-30.55; P<.001), physical activity (standardized mean difference [SMD]=0.42, 95% CI 0.04-0.81; P=.03), and adherence to treatment (risk difference=0.19, 95% CI 0.11-0.28; P<.001) were significantly superior in the mHealth group. Furthermore, both the physical and mental dimensions of quality of life were better in the mHealth group (SMD=0.26, 95% CI 0.09-0.44; P=.004 and SMD=0.27, 95% CI 0.06-0.47; P=.01, respectively). In addition, hospital readmissions for all causes and cardiovascular causes were statistically higher in the control group than in the mHealth group (SMD=–0.03, 95% CI –0.05 to –0.00; P=.04 vs SMD=–0.04, 95% CI –0.07 to –0.00; P=.05). Conclusions: mHealth technology has a positive effect on patients who have experienced a coronary event in terms of their exercise capacity, physical activity, adherence to medication, and physical and mental quality of life, as well as readmissions for all causes and cardiovascular causes. Trial Registration: PROSPERO (International Prospective Register of Systematic Reviews) CRD42022299931; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=299931 %M 36459396 %R 10.2196/39593 %U https://mhealth.jmir.org/2022/12/e39593 %U https://doi.org/10.2196/39593 %U http://www.ncbi.nlm.nih.gov/pubmed/36459396 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 12 %P e38649 %T Preliminary Use and Outcome Data of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time Series and Matched Analysis %A Teepe,Gisbert Wilhelm %A Kowatsch,Tobias %A Hans,Felix Patricius %A Benning,Leo %+ University Emergency Center, Medical Center - University of Freiburg, Sir-Hans-A-Krebs-Strasse, Freiburg, 79106, Germany, 49 76127033266, leo.benning@uniklinik-freiburg.de %K digital health %K home exercise %K musculoskeletal conditions %K digital intervention %K exercise %K physical activity %K smartphone %K pain %K management %K back pain %K hip pain %K knee pain %K mobility %K intervention %D 2022 %7 2.12.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Musculoskeletal conditions are among the main contributors to the global burden of disease. International guidelines consider patient education and movement exercises as the preferred therapeutic option for unspecific and degenerative musculoskeletal conditions. Innovative and decentralized therapeutic means are required to provide access to and availability of such care to meet the increasing therapeutic demand for this spectrum of conditions. Objective: This retrospective observational study of preliminary use and outcome data explores the clinical outcomes of Vivira (hereafter referred to as “program”), a smartphone-based program for unspecific and degenerative pain in the back, hip, and knee before it received regulatory approval for use in the German statutory health insurance system. Methods: An incomplete matched block design was employed to assess pain score changes over the intended 12-week duration of the program. Post hoc analyses were performed. In addition, a matched comparison of self-reported functional scores and adherence rates is presented. Results: A total of 2517 participants met the inclusion criteria and provided sufficient data to be included in the analyses. Overall, initial self-reported pain scores decreased significantly from an average of 5.19 out of 10 (SD 1.96) to an average of 3.35 out of 10 (SD 2.38) after 12 weeks. Post hoc analyses indicate a particularly emphasized pain score reduction over the early use phases. Additionally, participants with back pain showed significant improvements in strength and mobility scores, whereas participants with hip or knee pain demonstrated significant improvements in their coordination scores. Across all pain areas and pain durations, a high yet expected attrition rate could be observed. Conclusions: This observational study provides the first insights into the clinical outcomes of an exercise program for unspecific and degenerative back, hip, and knee pain. Furthermore, it demonstrates a potential secondary benefit of improved functionality (ie, strength, mobility, coordination). However, as this study lacks confirmatory power, further research is required to substantiate the clinical outcomes of the program assessed. Trial Registration: German Clinical Trials Register DRKS00021785; https://drks.de/search/en/trial/DRKS00021785 %M 36459399 %R 10.2196/38649 %U https://mhealth.jmir.org/2022/12/e38649 %U https://doi.org/10.2196/38649 %U http://www.ncbi.nlm.nih.gov/pubmed/36459399 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 11 %P e39501 %T The Relationship Between the Big Five Personality Traits and the Theory of Planned Behavior in Using Mindfulness Mobile Apps: Cross-sectional Survey %A Kim,Sunghak %A Park,Jin Young %A Chung,Kyungmi %+ Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Yonsei University Health System, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea, 82 10 4234 3442, chungkyungmi@yuhs.ac %K personality traits %K Theory of Planned Behavior %K mindfulness %K mobile apps %K mental health %D 2022 %7 30.11.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Mindfulness has emerged as a promising approach toward improving mental health. Interest in mindfulness mobile app services has also increased in recent years. Understanding the determinants of mindfulness behavior is essential to predict people’s utilization of mindfulness mobile apps and beneficial for developing and implementing relevant intervention strategies. Nevertheless, little has been done to determine the predictors of mindfulness behavior. Objective: This study investigates the association between the Big Five personality traits and the Theory of Planned Behavior (TPB) variables in the context of using mindfulness mobile apps to explore the potential indirect effects of conscientiousness and neuroticism on people’s behavioral intention for mindfulness, mediated by their attitude toward mindfulness, subjective norm about mindfulness, and perceived behavior control over mindfulness. Methods: The authors conducted an online, cross-sectional survey in December 2021. Structural equation modeling was conducted to evaluate the overall model fit and test possible linkages among conscientiousness, neuroticism, attitude toward mindfulness, subjective norm about mindfulness, perceived behavior control over mindfulness, and behavioral intention for mindfulness. Bootstrapping mediation analyses were also conducted to test the potential mediating effect in the model. Results: A total of 297 Korean participants’ responses (153 males and 144 females) were analyzed. The proposed model had a good fit. Conscientiousness was correlated with attitude toward mindfulness (β=.384, P<.001), subjective norm about mindfulness (β=.249, P<.001), and perceived behavior control over mindfulness (β=.443, P<.001). Neuroticism was not correlated with attitude toward mindfulness (β=−.072, P=.28), but was correlated with subjective norm about mindfulness (β=.217, P=.003) and perceived behavior control over mindfulness (β=−.235, P<.001). Attitude toward mindfulness (β=.508, P<.001), subjective norm about mindfulness (β=.132, P=.01), and perceived behavior control over mindfulness (β=.540, P<.001) were separately correlated with behavioral intention for mindfulness. Conscientiousness was not directly correlated with behavioral intention for mindfulness (β=−.082, P=.27), whereas neuroticism was directly correlated with behavioral intention for mindfulness (β=.194, P=.001). Conscientiousness was indirectly linked with behavioral intention for mindfulness through attitude toward mindfulness (B=0.171, 95% CI 0.103-0.251) and perceived behavior control over mindfulness (B=0.198, 95% CI 0.132-0.273) but not through subjective norm about mindfulness (B=0.023, 95% CI −0.002 to 0.060). Neuroticism was indirectly linked with behavioral intention for mindfulness via perceived behavior control over mindfulness (B=−0.138, 95% CI −0.197 to −0.088) but not via subjective norm about mindfulness (B=0.021, 95% CI −0.002 to 0.059). Conclusions: The results show that the integration of the Big Five personality traits and TPB constructs is useful in predicting the use of mindfulness mobile apps. Focusing on conscientiousness and neuroticism in developing information dissemination and implementation strategies for enhancing mindfulness behavior using mobile apps may lead to the successful promotion of mindfulness mobile apps and adherence to mindfulness techniques. %M 36449344 %R 10.2196/39501 %U https://www.jmir.org/2022/11/e39501 %U https://doi.org/10.2196/39501 %U http://www.ncbi.nlm.nih.gov/pubmed/36449344 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 11 %P e41891 %T Implementation of e–Mental Health Interventions for Informal Caregivers of Adults With Chronic Diseases: Mixed Methods Systematic Review With a Qualitative Comparative Analysis and Thematic Synthesis %A Coumoundouros,Chelsea %A Mårtensson,Erika %A Ferraris,Giulia %A Zuidberg,Justine Margaux %A von Essen,Louise %A Sanderman,Robbert %A Woodford,Joanne %+ Healthcare Sciences and e-Health, Department of Women’s and Children’s Health, Uppsala University, MTC-huset: Dag Hammarskjölds väg 14B, 1 tr, Uppsala, 751 85, Sweden, 46 729 999 211, chelsea.coumoundouros@kbh.uu.se %K informal caregivers %K e–mental health %K implementation %K chronic diseases %K systematic review %K thematic synthesis %K qualitative comparative analysis %K Consolidated Framework for Implementation Research %D 2022 %7 30.11.2022 %9 Review %J JMIR Ment Health %G English %X Background: Informal caregivers commonly experience mental health difficulties related to their caregiving role. e–Mental health interventions provide mental health support in a format that may be more accessible to informal caregivers. However, e–mental health interventions are seldom implemented in real-world practice. Objective: This mixed methods systematic review aimed to examine factors associated with the effectiveness and implementation of e–mental health interventions for informal caregivers of adults with chronic diseases. To achieve this aim, two approaches were adopted: combinations of implementation and intervention characteristics sufficient for intervention effectiveness were explored using qualitative comparative analysis, and barriers to and facilitators of implementation of e–mental health interventions for informal caregivers were explored using thematic synthesis. Methods: We identified relevant studies published from January 1, 2007, to July 6, 2022, by systematically searching 6 electronic databases and various secondary search strategies. Included studies reported on the effectiveness or implementation of e–mental health interventions for informal caregivers of adults with cancer, chronic obstructive pulmonary disease, dementia, diabetes, heart disease, or stroke. Randomized controlled trials reporting on caregivers’ mental health outcomes were included in a crisp-set qualitative comparative analysis. We assessed randomized controlled trials for bias using the Risk of Bias 2.0 tool, and we assessed how pragmatic or explanatory their trial design was using the Pragmatic Explanatory Continuum Indicator Summary 2 tool. Studies of any design reporting on implementation were included in a thematic synthesis using the Consolidated Framework for Implementation Research to identify barriers to and facilitators of implementation. Results: Overall, 53 reports, representing 29 interventions, were included in the review. Most interventions (27/29, 93%) focused on informal cancer or dementia caregivers. In total, 14 reports were included in the qualitative comparative analysis, exploring conditions including the presence of peer or professional support and key persuasive design features. Low consistency and coverage prevented the determination of condition sets sufficient for intervention effectiveness. Overall, 44 reports were included in the thematic synthesis, and 152 barriers and facilitators were identified, with the majority related to the intervention and individual characteristic domains of the Consolidated Framework for Implementation Research. Implementation barriers and facilitators in the inner setting (eg, organizational culture) and outer setting (eg, external policies and resources) domains were largely unexplored. Conclusions: e–Mental health interventions for informal caregivers tend to be well-designed, with several barriers to and facilitators of implementation identified related to the intervention and individual user characteristics. Future work should focus on exploring the views of stakeholders involved in implementation to determine barriers to and facilitators of implementing e–mental health interventions for informal caregivers, focusing on inner and outer setting barriers and facilitators. Trial Registration: PROSPERO (International Prospective Register of Systematic Reviews) CRD42020155727; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020155727 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2019-035406 %M 36314782 %R 10.2196/41891 %U https://mental.jmir.org/2022/11/e41891 %U https://doi.org/10.2196/41891 %U http://www.ncbi.nlm.nih.gov/pubmed/36314782 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 11 %P e38357 %T Enrollment and Completion Characteristics for Novel Remote Delivery Modes of the Self-management Programs During the COVID-19 Pandemic: Exploratory Analysis %A Pullyblank,Kristin %A Atav,Serdar %+ Center for Rural Community Health, Bassett Research Institute, Bassett Medical Center, One Atwell Road, Cooperstown, NY, 13326, United States, 1 6075476711, kristin.pullyblank@bassett.org %K self-management programs %K self management %K internet-based intervention %K health promotion %K COVID-19 %K health equity %K socioeconomic status %K remote healthcare %K health delivery %K virtual care %K remote care %K remote delivery %K videoconference %K videoconferencing %K adherence %K attrition %K completion %K virtual health %D 2022 %7 30.11.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: In-person, evidence-based, peer-facilitated chronic disease self-management programs have been shown to be effective for individuals from a variety of backgrounds, including rural and minority populations and those with lower socioeconomic status. Based in social learning theory, these programs use group processes to help participants better manage their chronic disease symptoms and improve their quality of life. During the pandemic, these in-person programs were forced to rapidly transition to remote delivery platforms, and it was unclear whether doing so increased disparities within our rural population. Objective: The objectives of this analysis were to ascertain self-management program enrollment and completion characteristics between 2 remote delivery platforms, as well as determine the individual level characteristics that drove enrollment and completion across delivery modes. Methods: We analyzed enrollment and completion characteristics of 183 individuals who either enrolled in a self-management workshop delivered through a web-based videoconference (VC) system or through a traditional, audio-only conference call (CC) offered by our health care network between April and December 2020. Chi-square tests of association were used to describe the characteristics of and differences between groups. Logistic regression analysis was used to determine significant predictors of enrollment and completion. Results: Those who enrolled in the VC platform were significantly likelier to be younger and college educated than those who enrolled in the CC platform. Those who completed a program, regardless of delivery mode, were likelier to be older and college educated than those who did not complete a program. Multivariate analyses indicated that of those enrolled in the CC platform, completers were likelier to not be enrolled in Medicaid. Among those enrolled in the VC platform, completers were older, college graduates, female, and likelier to have reported poorer health than those who did not complete the program. Conclusions: The transition of self-management programs to remote delivery modes, particularly to those that rely on VC platforms, revealed that certain demographic groups may no longer be able or willing to access the service. Efforts need to be made to increase engagement in remote self-management workshops. In addition, equivalent quality services that do not rely on a digital platform must continue to be offered in order to promote health equity. %M 36413622 %R 10.2196/38357 %U https://formative.jmir.org/2022/11/e38357 %U https://doi.org/10.2196/38357 %U http://www.ncbi.nlm.nih.gov/pubmed/36413622 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 11 %P e37552 %T Assessing the Content and Quality of Digital Tools for Managing Gestational Weight Gain: Systematic Search and Evaluation %A Brammall,Bonnie R %A Garad,Rhonda M %A Boyle,Jacqueline A %A Hayman,Melanie J %A de Jersey,Susan J %A Teede,Helena J %A Hong,Quoc V %A Carrandi,Alayna %A Harrison,Cheryce L %+ Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Kanooka Grove, Clayton, 3168, Australia, 61 3 8572 2662, cheryce.harrison@monash.edu %K digital %K gestational %K weight %K tracking %K pregnancy %D 2022 %7 25.11.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital health resources have the potential to assist women in optimizing gestational weight gain (GWG) during pregnancy to improve maternal health outcomes. Objective: In this study, we aimed to evaluate the quality and behavior change potential of publicly available digital tools (websites and apps) that facilitate GWG tracking. Methods: Digital tools were identified using key search terms across website search engines and app stores and evaluated using the Mobile App Rating Scale, the App Behavior Change Scale, as well as criteria to evaluate the rigor and safety of GWG information. Results: Overall, 1085 tools were screened for inclusion (162 websites and 923 apps), and 19 were deemed eligible. The mean Mobile App Rating Scale quality score was 3.31 (SD 0.53) out of 5, ranging from 2.26 to 4.39, and the mean App Behavior Change Scale score was 6 (SD 3.4) out of 21, ranging from 19 to 0. Of the 19 items used to evaluate rigor of GWG advice, most tools (n=11, 57.9%) contained ≤3 items. Conclusions: This review emphasizes the substantial limitations in current digital resources promoting the monitoring and optimization of GWG. Most tools were of low quality, had minimal behavior change potential, and were potentially unsafe, with minimal linkage to evidence-based information or partnership with health care. %M 36427237 %R 10.2196/37552 %U https://www.jmir.org/2022/11/e37552 %U https://doi.org/10.2196/37552 %U http://www.ncbi.nlm.nih.gov/pubmed/36427237 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 11 %N 2 %P e35880 %T A Computerized Pharmacy Decision Support System (PDSS) for Headache Management: Observational Pilot Study %A Perrot,Serge %A Trouvin,Anne-Priscille %A Clairaz-Mahiou,Beatrice %A Tempremant,Grégory %A Martial,François %A Brément,Diane %A Cherkaoui,Asmaa %+ Centre de la douleur, Hôpital Cochin, 27 rue du Faubourg St Jacques, Paris, 75014, France, 33 158 413 040, serge.perrot@aphp.fr %K headache %K pharmacy %K counselling %K over-the-counter (OTC) medication %K self-medication %K decision support system %K patient perception %D 2022 %7 25.11.2022 %9 Original Paper %J Interact J Med Res %G English %X Background: Headaches are common and often lead patients to seek advice from a pharmacist and consequently self-medicate for relief. Computerized pharmacy decision support systems (PDSSs) may be a valuable resource for health care professionals, particularly for community pharmacists when counseling patients with headache, to guide treatment with over-the-counter medications and recognize patients who require urgent or specialist care. Objective: This observational pilot study aimed to evaluate a newly developed PDSS web app for the management of patients seeking advice from a pharmacy for headache. This study examined the use of the PDSS web app and if it had an impact on patient or pharmacy personnel counseling, pharmacy personnel perception, and patient perception. Methods: The PDSS web app was developed according to Francophone des Sciences Pharmaceutiques Officinales (SFSPO) recommendations for headache management, and was made available to pharmacies in 2 regions of France: Hauts de France and New Aquitaine. Pharmacy personnel received 2 hours of training before using the PDSS web app. All people who visited the pharmacies for headache between June 29, 2020, and December 31, 2020, were offered an interview based on the PDSS web app and given information about the next steps in the management of headaches and advice on the proper use of their medication. Patients and pharmacy personnel reported satisfaction with the PDSS web app following consultations or during a follow-up period (January 18 to 25, 2021). Results: Of the 44 pharmacies that received the PDSS web app, 38 pharmacies representing 179 pharmacy personnel used the PDSS web app, and 435 people visited these pharmacies for headache during the study period. Of these, 70.0% (305/435) asked for immediate over-the-counter analgesics for themselves and consulted with pharmacy personnel with the use of the PDSS web app. The majority of these patients were given advice and analgesics for self-medication (346/435, 79.5%); however, 17.0% (74/435) were given analgesics and referred to urgent medical services, and 3.5% (15/435) were given analgesics and referred to their general practitioner. All pharmacy personnel (n=45) were satisfied or very satisfied with the use of the PDSS web app, and a majority thought it improved the quality of their care (41/44, 93.2%). Most pharmacy personnel felt that the PDSS web app modified their approach to management of headache (29/45, 64.4%). Most patients were very satisfied with the PDSS web app during their consultation (96/119, 80.7%), and all felt mostly or completely reassured. Conclusions: Use of the PDSS web app for the management of patients with headache improved the perceived quality of care for pharmacy personnel and patients. The PDSS web app was well accepted and effectively identified patients who required specialist medical management. Further studies should identify additional “red flags” for more effective screening and management of patients via the PDSS web app. Larger studies can measure the impact of the PDSS web app on the lives of patients and how safe or appropriate pharmacy personnel recommendations are. %M 36427228 %R 10.2196/35880 %U https://www.i-jmr.org/2022/2/e35880 %U https://doi.org/10.2196/35880 %U http://www.ncbi.nlm.nih.gov/pubmed/36427228 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 11 %P e30285 %T Identifying Personality Characteristics and Indicators of Psychological Well-Being Associated With Attrition in the Motivation Makes the Move! Physical Activity Intervention: Randomized Technology-Supported Trial %A Kaseva,Kaisa %A Tervaniemi,Mari %A Heikura,Enni %A Kostilainen,Kaisamari %A Pöyhönen-Alho,Maritta %A Shoemaker,J Kevin %A Petrella,Robert J %A Peltonen,Juha E %+ Department of Sport and Exercise Medicine, Clinicum, Faculty of Medicine, University of Helsinki, Alppikatu 2, Helsinki, 00530, Finland, 358 443077737, kaisa.kaseva@helsinki.fi %K randomized trial %K physical activity %K lifestyles %K personality %K psychological well-being %K study attrition %K mental health %K lifestyle interventions %D 2022 %7 25.11.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Data attrition has been a common problem in longitudinal lifestyle interventions. The contributors to attrition in technology-supported physical activity interventions have not been thoroughly studied. Objective: The present study examined the roles of personality characteristics and indicators of psychological well-being in data attrition within a technology-supported, longitudinal intervention study with overweight adults. Methods: Participants (N=89) were adults from the Motivation Makes the Move! intervention study. Data attrition was studied after a 3-month follow-up. Participants’ personality characteristics were studied using the Short Five self-report questionnaire. Psychological well-being indicators were assessed with the RAND 36-item health survey, Positive and Negative Affect Schedule, and Beck Depression Inventory. Logistic regression analyses were conducted to assess the risk of discontinuing the study. The analyses were adjusted for sex, age, study group, and educational status. Results: At the 3-month follow-up, 65 of 89 participants (73% of the initial sample) had continued in the study. Participants’ personality characteristics and indicators of psychological well-being were not associated with the risk of dropping out of the study (all P values >.05). The results remained the same after covariate controls. Conclusions: Participant attrition was not attributable to personality characteristics or psychological well-being in the Motivation Makes the Move! study conducted with overweight adults. As attrition remains a challenge within longitudinal, technology-supported lifestyle interventions, attention should be paid to the potentially dynamic natures of personality and psychological well-being, as well as other elements beyond these. Trial Registration: ClinicalTrials.gov NCT02686502; https://clinicaltrials.gov/ct2/show/NCT02686502 %M 36427239 %R 10.2196/30285 %U https://formative.jmir.org/2022/11/e30285 %U https://doi.org/10.2196/30285 %U http://www.ncbi.nlm.nih.gov/pubmed/36427239 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 11 %P e41658 %T Outcomes of a Comprehensive Mobile Smoking Cessation Program With Nicotine Replacement Therapy in Adult Smokers: Pilot Randomized Controlled Trial %A Marler,Jennifer D %A Fujii,Craig A %A Utley,MacKenzie T %A Balbierz,Daniel J %A Galanko,Joseph A %A Utley,David S %+ Pivot Health Technologies Inc., 1010 Commercial St., Suite C, San Carlos, CA, 94070, United States, 1 4157577696, marler@pivot.co %K smoking cessation %K digital health %K smartphone %K digital sensor %K carbon monoxide %K breath sensor %K biofeedback %K mobile apps %K health promotion %K app %K mobile phone %D 2022 %7 24.11.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Cigarette smoking remains the leading cause of preventable illness and death, underscoring ongoing need for evidence-based solutions. Pivot, a US Clinical Practice Guideline–based mobile smoking cessation program, comprises a personal carbon monoxide breath sensor; a smartphone app; in-app, text-based human-provided coaching; nicotine replacement therapy; and a moderated web-based community. Promising Pivot cohort studies have established the foundation for comparative assessment. Objective: This study aimed to compare engagement, retention, attitudes toward quitting smoking, smoking behavior, and participant feedback between Pivot and QuitGuide, a US Clinical Practice Guideline–based smoking cessation smartphone app from the National Cancer Institute. Methods: In this remote pilot randomized controlled trial, cigarette smokers in the United States were recruited on the web and randomized to Pivot or QuitGuide. Participants were offered 12 weeks of free nicotine replacement therapy. Data were self-reported via weekly web-based questionnaires for 12 weeks and at 26 weeks. Outcomes included engagement and retention, attitudes toward quitting smoking, smoking behavior, and participant feedback. The primary outcome was self-reported app openings at 12 weeks. Cessation outcomes included self-reported 7- and 30-day point prevalence abstinence (PPA), abstinence from all tobacco products, and continuous abstinence at 12 and 26 weeks. PPA and continuous abstinence were biovalidated via breath carbon monoxide samples. Results: Participants comprised 188 smokers (94 Pivot and 94 QuitGuide): mean age 46.4 (SD 9.2) years, 104 (55.3%) women, 128 (68.1%) White individuals, and mean cigarettes per day 17.6 (SD 9.0). Engagement via mean “total app openings through 12 weeks” (primary outcome) was Pivot, 157.9 (SD 210.6) versus QuitGuide, 86.5 (SD 66.3; P<.001). Self-reported 7-day PPA at 12 and 26 weeks was Pivot, 35% (33/94) versus QuitGuide, 28% (26/94; intention to treat [ITT]: P=.28) and Pivot, 36% (34/94) versus QuitGuide, 27% (25/94; ITT: P=.12), respectively. Self-reported 30-day PPA at 12 and 26 weeks was Pivot, 29% (27/94) versus QuitGuide, 22% (21/94; ITT: P=.32) and Pivot, 32% (30/94) versus QuitGuide, 22% (21/94; ITT: P=.12), respectively. The biovalidated abstinence rate at 12 weeks was Pivot, 29% (27/94) versus QuitGuide, 13% (12/94; ITT: P=.008). Biovalidated continuous abstinence at 26 weeks was Pivot, 21% (20/94) versus QuitGuide, 10% (9/94; ITT: P=.03). Participant feedback, including ease of setup, impact on smoking, and likelihood of program recommendation were favorable for Pivot. Conclusions: In this randomized controlled trial comparing the app-based smoking cessation programs Pivot and QuitGuide, Pivot participants had higher engagement and biovalidated cessation rates and more favorable user feedback at 12 and 26 weeks. These findings support Pivot as an effective, durable mobile smoking cessation program. Trial Registration: ClinicalTrials.gov NCT04955639; https://clinicaltrials.gov/ct2/show/NCT04955639 %M 36257323 %R 10.2196/41658 %U https://mhealth.jmir.org/2022/11/e41658 %U https://doi.org/10.2196/41658 %U http://www.ncbi.nlm.nih.gov/pubmed/36257323 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 11 %P e37843 %T Effects of a Smartphone-Based Out-of-Hospital Screening App for Neonatal Hyperbilirubinemia on Neonatal Readmission Rates and Maternal Anxiety: Randomized Controlled Trial %A Yan,Qin %A Gong,Yanhong %A Luo,Qing %A Yin,Xiaoxv %A Yang,Ling %A Wang,Honglin %A Feng,Juan %A Xing,Kaihui %A Huang,Yan %A Huang,Chuican %A Fan,Lichun %+ Department of Child Heath Care, Hainan Women and Children’s Medical Center, No.75 South of Longkun Road, Haikou, 570206, China, 86 18689852199, flc007@hainmc.edu.cn %K eHealth %K mHealth %K mobile apps %K maternal anxiety %K neonatal jaundice %K neonatal readmission %K neonatal screening %K mobile phone %D 2022 %7 23.11.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Neonatal hyperbilirubinemia is one of the leading causes of neonatal readmission—especially severe hyperbilirubinemia and its complications—and it influences disease burden as well as neonatal and maternal health. Smartphones have been shown to have satisfactory accuracy in screening neonatal bilirubin levels, but the impact of this technology on neonatal health care service and maternal health outcomes is still unknown. Objective: The aim of this study was to evaluate the impact of a smartphone-based out-of-hospital neonatal jaundice screening program on neonatal readmission rates for jaundice and related maternal anxiety. Methods: This was a 2-arm, unblinded, randomized controlled trial with 30 days of intervention and follow-up periods. From August 2019 to August 2020, healthy mother-infant dyads were recruited on-site from 3 public hospitals in Hainan, China. Intervention group mothers used the smartphone app to routinely monitor neonatal jaundice at home under the web-based guidance of pediatricians. Control group participants received routine care. The primary study outcome was the neonatal readmission rate due to jaundice within 30 days of the first hospital discharge. The secondary outcome was the maternal anxiety score associated with neonatal jaundice. The data were collected through a self-assessed questionnaire. All participants were included in the analysis (intention-to-treat). Results: In this study, 1424 mother-infant dyads were recruited, comprising 1424 mothers and 1424 newborns. The median age of the mothers was 29 (IQR 26-32) years, and there were 714 (50.1%) male neonates. These mother-infant dyads were randomly assigned to the intervention group and the control group, with 712 dyads in each group; only 1187 of these dyads completed the follow-up. We found that the adjusted 30-day neonatal readmission rate due to jaundice reduced by 10.5% (71/605, 11.7% vs 141/582, 24.2%; 95% CI 5%-15.9%; odds ratio 0.4, 95% CI 0.3-0.5; P<.001) and the relevant maternal anxiety mean score decreased by 3.6 (95% CI –4.4 to –2.8; β=–3.6, 95% CI –4.5 to –2.8; P<.001) in the intervention group compared to those in the routine care group. Conclusions: Our study shows that the smartphone-based out-of-hospital screening method for neonatal hyperbilirubinemia decreased the neonatal readmission rate within 30 days from the first discharge and improved maternal mental health to some degree, thus demonstrating the usefulness of this screening app for follow-up in pediatric care. Trial Registration: China Clinical Trial Registration Center, ChiCTR2100049567; http://www.chictr.org.cn/showproj.aspx?proj=64245 %M 36416882 %R 10.2196/37843 %U https://www.jmir.org/2022/11/e37843 %U https://doi.org/10.2196/37843 %U http://www.ncbi.nlm.nih.gov/pubmed/36416882 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 11 %P e40059 %T Effect of a 4-Week Internet-Delivered Mindfulness-Based Cancer Recovery Intervention on the Symptom Burden and Quality of Life of Patients With Breast Cancer: Randomized Controlled Trial %A Wang,Luyao %A Chen,Xing %A Peng,Yueyang %A Zhang,Kun %A Ma,Jun %A Xu,Lin %A Liu,Zixuan %A Liu,Li %A Luo,Yang %A Gu,Can %+ Xiangya School of Nursing, Central South University, XiaoQian Bldg, 6th FI, 172 TongZiPo St, Changsha, 410013, China, 86 82650269, gucan_cs@csu.edu.cn %K mindfulness-based cancer recovery %K mindfulness-based intervention %K cancer-related symptom %K quality of life %K breast cancer %K internet-delivered intervention %K mobile phone %D 2022 %7 22.11.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Mindfulness-based interventions (MBIs) can improve the symptoms and psychological well-being of patients with breast cancer. However, standard MBIs are an 8-week program delivered face-to-face, which may be inconvenient for patients with cancer. Many attempts have been made to adapt MBIs to increase their accessibility for patients with cancer while maintaining their therapeutic components and efficacy. Objective: This study aimed to investigate the effectiveness of a 4-week internet-delivered mindfulness-based cancer recovery (iMBCR) program in reducing symptom burden and enhancing the health-related quality of life (HRQoL) of patients with breast cancer. Methods: A total of 103 postoperative patients with breast cancer (stages 0 to IV) were randomly assigned to an iMBCR group (4-week iMBCR; n=51, 49.5%) or a control group (usual care and 4-week program of health education information; n=52, 50.5%). The study outcomes included symptom burden and HRQoL, as measured by the MD Anderson Symptom Inventory and the Functional Assessment of Cancer Therapy-Breast scale. All data were collected at baseline (T0), after the intervention (T1), and at 1-month follow-up (T2). Data analysis followed the intention-to-treat principle. Linear mixed models were used to assess the effects over time of the iMBCR program. Results: Participants in the iMBCR group had significantly larger decreases in symptom burden than those in the control group at T1 (mean difference –11.67, 95% CI –16.99 to –6.36), and the decreases were maintained at T2 (mean difference –11.83, 95% CI –18.19 to –5.46). The HRQoL score in the iMBCR group had significantly larger improvements than that in the control group at T1 and T2 (mean difference 6.66, 95% CI 3.43-9.90 and mean difference 11.94, 95% CI 7.56-16.32, respectively). Conclusions: Our preliminary findings suggest that the iMBCR program effectively improved the symptom burden and HRQoL of patients with breast cancer, and the participants in the iMBCR group demonstrated good adherence and completion rates. These results indicate that the iMBCR intervention might be a promising way to reduce symptom burden and improve HRQoL of patients with cancer. Trial Registration: Chinese Clinical Trial Registry ChiCTR2000038980; http://www.chictr.org.cn/showproj.aspx?proj=62659 %M 36413385 %R 10.2196/40059 %U https://www.jmir.org/2022/11/e40059 %U https://doi.org/10.2196/40059 %U http://www.ncbi.nlm.nih.gov/pubmed/36413385 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 11 %P e41800 %T Efficacy of the Mental Health App “Intellect” to Improve Body Image and Self-compassion in Young Adults: A Randomized Controlled Trial With a 4-Week Follow-up %A Ong,Wen Yi %A Sündermann,Oliver %+ Department of Psychology, National University of Singapore, 9 Arts Link, Block AS4, Singapore, 117572, Singapore, 65 93571995, oliver@intellect.co %K body image %K body image program %K mobile health app %K mHealth app %K mobile-based interventions %K dissonance-based interventions %K self-compassion %D 2022 %7 21.11.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Body image concerns are prevalent among young adults, who may be vulnerable to developing body image concerns because of particular risk factors associated with this life period. With technological advancements, digital mobile health (mHealth) apps are cost-effective and scalable interventions. Thus, mHealth apps can be explored as a form of prevention effort to alleviate body image concerns in young adults. Objective: In this randomized controlled trial, we examined the effectiveness of a self-guided mHealth app in improving body image and self-compassion in a sample of university students. Methods: Participants (N=310) were randomized to a 9-day self-guided body image and self-compassion mHealth app (n=149) and to an active waitlist control group (n=161), where they completed a similarly structured 9-day program on cooperation. Both programs consisted of content learning and activities such as quizzes, with the number and length of activities matched for both programs. Measures were obtained at baseline, upon completion of the programs (after the intervention), and at 4-week follow-up. Results: The intervention group for female participants reported significant reduction in body dissatisfaction (P<.001) and improvements in body appreciation (P<.001) and self-compassion (P=.001) compared with the active waitlist control group after the intervention. Similarly, for male participants after the intervention, a significant reduction was found in the intervention group in body dissatisfaction (P<.001) after the intervention as well as improvements in body appreciation (P=.02) and self-compassion (P=.047). The effects were maintained at 4-week follow-up for female participants on body dissatisfaction (P<.001), body appreciation (P<.001), and self-compassion (P=.02) but not for male participants. On body image risk factors, significant reductions were found for female participants after the intervention for thin-ideal internalization (P<.001), peer pressure (P=.002), and media pressure (P<.001) after the intervention, while the effects were only maintained for thin-ideal internalization (P=.008) and media pressure (P=.01) at 4-week follow-up, compared with the active waitlist control group. As for male participants, no intervention effects were found both after the intervention and at follow-up for all body image risk factors of muscularity internalization, peer pressure, and media pressure. Both apps were acceptable and participants engaged equally across the intervention and active waitlist control groups, as indicated on a measure of app engagement (P=.76). Conclusions: This study provides preliminary evidence for a self-guided mHealth app in improving body image concerns and self-compassion in young adult university students. Future studies should include longer follow-ups, and examine its effects with the wider populations of young adults. Trial Registration: ClinicalTrials.gov NCT04977973; https://clinicaltrials.gov/ct2/show/NCT04977973 %M 36409542 %R 10.2196/41800 %U https://mhealth.jmir.org/2022/11/e41800 %U https://doi.org/10.2196/41800 %U http://www.ncbi.nlm.nih.gov/pubmed/36409542 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 11 %P e38255 %T Usage of a Web-Based eHealth Intervention for Women With Stress Urinary Incontinence: Mixed Methods Study %A Firet,Lotte %A Teunissen,Theodora Alberta Maria %A Kool,Rudolf Bertijn %A Notten,Kim Josephina Bernadette %A Lagro-Janssen,Antoinette Leonarda Maria %A van der Vaart,Huub %A Assendelft,Willem Jan Jozef %+ Department of Primary and Community Care, Radboud Institute for Health Sciences, Radboud University Medical Center, Geert Grooteplein 21, Nijmegen, Postbox 9101, Netherlands, 31 243618181, lotte.firet@radboudumc.nl %K eHealth %K urinary incontinence %K women %K usage %K nonattrition %K adherence %K implementation science %K pelvic floor muscle training %K mixed methods design %D 2022 %7 17.11.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Stress urinary incontinence (SUI) is highly prevalent among women and has an impact on physical and mental well-being. eHealth with pelvic floor muscle training (PFMT) has shown to be effective in reducing complaints. The usage and nonusage attrition of eHealth for SUI is unknown, but knowledge about users and their usage patterns is crucial for implementation purposes. Objective: This study aimed to evaluate how an eHealth intervention for SUI was used and by whom, explore reasons for nonusage attrition, and determine what factors are associated with usage. Methods: In this observational, mixed methods study, women with SUI independently registered to a web-based eHealth intervention, Baas over je blaas, a translation of the Swedish internet program Tät-treatment of stress urinary incontinence. Log-in data were collected during 3-month access to the website, and surveys were sent at baseline. Participants were divided into three user groups (low, intermediate, and high) and were compared based on sociodemographic and incontinence-related characteristics. Nominal logistic regression analysis was used to study factors associated with eHealth usage. Qualitative content analysis was used for open-ended questions about nonusage attrition and about facilitators of and barriers to eHealth usage. Results: Participants (n=561) had a mean age of 50.3 (SD 12.1) years, and most of them (340/553, 61.5%) had never visited a health care professional for SUI before. Most users were low users (295/515, 57.3%), followed by intermediate users (133/515, 25.8%) and high users (87/515, 16.9%). User groups differed significantly in age (48.3, SD 12 years; 52.1, SD 11.6 years; and 55.3, SD 10.9 years; P<.001) and in their expected ability to train the pelvic floor muscles (7.5, SD 1.4; 7.7, SD 1.4; and 8.1, SD 1.5 for low, intermediate, and high users, respectively; P=.006). Nonusage attrition was mainly caused by problems in integrating PFMT into everyday life. High age (>50 years), previous PFMT, and high expected ability to train the pelvic floor muscles are associated with high usage. Facilitators for eHealth usage were the clear explanation of exercises and the possibility of self-management. Barriers were its noncommittal character and the absence of personal contact. Conclusions: eHealth fulfills a need for women with SUI who have never received treatment. Those who discontinued prematurely did so mainly because it was difficult to integrate the training schedule into their everyday lives. High eHealth usage was more likely for women aged >50 years, with previous PFMT, and with high expectations about their ability to train the pelvic floor muscles. Knowledge of these user characteristics can guide clinicians and correct their misunderstandings about the suitable target population for this intervention. Furthermore, strategies for reinforcing expectations and self-efficacy are important to upscale eHealth usage, together with paying attention to people’s need for personal contact. International Registered Report Identifier (IRRID): RR2-10.2196/13164 %M 36394923 %R 10.2196/38255 %U https://www.jmir.org/2022/11/e38255 %U https://doi.org/10.2196/38255 %U http://www.ncbi.nlm.nih.gov/pubmed/36394923 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 11 %P e41463 %T Omnichannel Communication to Boost Patient Engagement and Behavioral Change With Digital Health Interventions %A Blasiak,Agata %A Sapanel,Yoann %A Leitman,Dana %A Ng,Wei Ying %A De Nicola,Raffaele %A Lee,V Vien %A Todorov,Atanas %A Ho,Dean %+ The Institute for Digital Medicine, Yong Loo Lin School of Medicine, National University of Singapore, 28 Medical Drive, #05-COR Centre for Life Sciences, Singapore, 117456, Singapore, 65 6601 7766, agata.blasiak@nus.edu.sg %K digital health intervention %K omnichannel engagement %K behavioral change %K communication channels %K personalized engagement %K health care %K patient care %K health care outcome %K patient engagement %K digital twin %K DHI %K digital health %K eHealth %K framework %K development %D 2022 %7 16.11.2022 %9 Viewpoint %J J Med Internet Res %G English %X Digital health interventions are being increasingly incorporated into health care workflows to improve the efficiency of patient care. In turn, sustained patient engagement with digital health interventions can maximize their benefits toward health care outcomes. In this viewpoint, we outline a dynamic patient engagement by using various communication channels and the potential use of omnichannel engagement to integrate these channels. We conceptualize a novel patient care journey where multiple web-based and offline communication channels are integrated through a “digital twin.” The principles of implementing omnichannel engagement for digital health interventions and digital twins are also broadly covered. Omnichannel engagement in digital health interventions implies a flexibility for personalization, which can enhance and sustain patient engagement with digital health interventions, and ultimately, patient quality of care and outcomes. We believe that the novel concept of omnichannel engagement in health care can be greatly beneficial to patients and the system once it is successfully realized to its full potential. %M 36383427 %R 10.2196/41463 %U https://www.jmir.org/2022/11/e41463 %U https://doi.org/10.2196/41463 %U http://www.ncbi.nlm.nih.gov/pubmed/36383427 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 11 %P e38206 %T Automated Digital Interventions and Smoking Cessation: Systematic Review and Meta-analysis Relating Efficiency to a Psychological Theory of Intervention Perspective %A Sha,Leihao %A Yang,Xia %A Deng,Renhao %A Wang,Wen %A Tao,YuJie %A Cao,HaiLing %A Ma,Qianshu %A Wang,Hao %A Nie,Yirou %A Leng,Siqi %A Lv,Qiuyue %A Li,Xiaojing %A Wang,Huiyao %A Meng,Yajing %A Xu,Jiajun %A Greenshaw,Andrew J %A Li,Tao %A Guo,Wan-jun %+ Mental Health Center and Sichuan Clinical Medical Research Center for Mental Disorders, West China Hospital of Sichuan University, No. 28 Dianxin South St, Chengdu, 610041, China, 86 28 8542356, guowjcn@163.com %K smoking cessation %K automated %K digital intervention %K psychological theory %K meta-analysis %K systematic review %K public health %K side effects %K interventions %K randomized controlled trial %K self-help %D 2022 %7 16.11.2022 %9 Review %J J Med Internet Res %G English %X Background: Smoking remains a highly significant preventable global public health problem. In this context, digital interventions offer great advantages in terms of a lack of biological side effects, possibility of automatic delivery, and consequent human resource savings relative to traditional interventions. Such interventions have been studied in randomized controlled trials (RCTs) but have not been systematically reviewed with the inclusion of text-based and multiplatform-based interventions. In addition, this area has not been evaluated from the perspective of the psychological theoretical basis of intervention. Objective: The aim of this paper is to assess the efficiency of digital interventions in RCT studies of smoking cessation and to evaluate the effectiveness of the strategies used for digital interventions. Methods: An electronic search of RCTs was conducted using PubMed, Embase, and the Cochrane Library by June 30, 2021. Eligible studies had to compare automated digital intervention (ADI) to the use of a self-help guideline or no intervention. Participants were current smokers (aged 16 years or older). As the main outcome, abstinence after endpoint was extracted from the studies. Systematic review and meta-analysis were conducted to assess the efficiency of ADIs. Metaregressions were conducted to assess the relationship between intervention theory and effectiveness. Results: A total of 19 trials (15,472 participants) were included in the analysis. The overall abstinence rate (95% CI) at the endpoint was 17.8% (17.0-18.7). The overall risk ratio of the intervention group compared to the controls at the endpoint was 17.8% (17.0-18.7). Cochrane risk-of-bias tool for randomized trials (ROB 2) suggested that most of the studies had a low risk of bias (56.3%). Psychological theory–related constructs or predictors, which refer to other theory-based concepts (rather than only behavioral theory) such as craving or anxiety, are associated with effectiveness. Conclusions: This study found that ADI had a clear positive effect compared to self-help guidelines or to no intervention, and effectiveness was associated with theory-related constructs or predictors. ADIs should be promoted by policy makers and clinical practitioners to address the huge gap between the need for smoking cessation and availability of traditional treatment resources. Possible increases in ADI efficiency may be achieved by optimally integrating psychotherapeutic theories and techniques. Trial Registration: PROSPERO CRD42021256593; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=256593 %M 36383408 %R 10.2196/38206 %U https://www.jmir.org/2022/11/e38206 %U https://doi.org/10.2196/38206 %U http://www.ncbi.nlm.nih.gov/pubmed/36383408 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 11 %P e38525 %T Design and Evaluation Challenges of Conversational Agents in Health Care and Well-being: Selective Review Study %A Kocaballi,Ahmet Baki %A Sezgin,Emre %A Clark,Leigh %A Carroll,John M %A Huang,Yungui %A Huh-Yoo,Jina %A Kim,Junhan %A Kocielnik,Rafal %A Lee,Yi-Chieh %A Mamykina,Lena %A Mitchell,Elliot G %A Moore,Robert J %A Murali,Prasanth %A Mynatt,Elizabeth D %A Park,Sun Young %A Pasta,Alessandro %A Richards,Deborah %A Silva,Lucas M %A Smriti,Diva %A Spillane,Brendan %A Zhang,Zhan %A Zubatiy,Tamara %+ School of Computer Science, University of Technology Sydney, Room CB11.7.103, 81 Broadway, Sydney, New South Wales, 2007, Australia, 61 295141103, baki.kocaballi@uts.edu.au %K conversational interfaces %K conversational agents %K dialog systems %K health care %K well-being %D 2022 %7 15.11.2022 %9 Review %J J Med Internet Res %G English %X Background: Health care and well-being are 2 main interconnected application areas of conversational agents (CAs). There is a significant increase in research, development, and commercial implementations in this area. In parallel to the increasing interest, new challenges in designing and evaluating CAs have emerged. Objective: This study aims to identify key design, development, and evaluation challenges of CAs in health care and well-being research. The focus is on the very recent projects with their emerging challenges. Methods: A review study was conducted with 17 invited studies, most of which were presented at the ACM (Association for Computing Machinery) CHI 2020 conference workshop on CAs for health and well-being. Eligibility criteria required the studies to involve a CA applied to a health or well-being project (ongoing or recently finished). The participating studies were asked to report on their projects’ design and evaluation challenges. We used thematic analysis to review the studies. Results: The findings include a range of topics from primary care to caring for older adults to health coaching. We identified 4 major themes: (1) Domain Information and Integration, (2) User-System Interaction and Partnership, (3) Evaluation, and (4) Conversational Competence. Conclusions: CAs proved their worth during the pandemic as health screening tools, and are expected to stay to further support various health care domains, especially personal health care. Growth in investment in CAs also shows the value as a personal assistant. Our study shows that while some challenges are shared with other CA application areas, safety and privacy remain the major challenges in the health care and well-being domains. An increased level of collaboration across different institutions and entities may be a promising direction to address some of the major challenges that otherwise would be too complex to be addressed by the projects with their limited scope and budget. %M 36378515 %R 10.2196/38525 %U https://www.jmir.org/2022/11/e38525 %U https://doi.org/10.2196/38525 %U http://www.ncbi.nlm.nih.gov/pubmed/36378515 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 11 %P e39657 %T The Codevelopment of “My Kidneys & Me”: A Digital Self-management Program for People With Chronic Kidney Disease %A Lightfoot,Courtney J %A Wilkinson,Thomas J %A Hadjiconstantinou,Michelle %A Graham-Brown,Matthew %A Barratt,Jonathan %A Brough,Christopher %A Burton,James O %A Hainsworth,Jenny %A Johnson,Vicki %A Martinez,Maria %A Nixon,Andrew C %A Pursey,Victoria %A Schreder,Sally %A Vadaszy,Noemi %A Wilde,Lucina %A Willingham,Fiona %A Young,Hannah M L %A Yates,Thomas %A Davies,Melanie J %A Smith,Alice C %+ Leicester Kidney Lifestyle Team, Department of Health Sciences, University of Leicester, University Road, Leicester, LE1 7RH, United Kingdom, 44 1162584346, courtney.lightfoot@leicester.ac.uk %K kidney disease awareness %K kidney disease knowledge %K program development %K eHealth %K digital health %K telehealth %K mobile health %K mHealth %K health promotion %K self-management behaviors %K mobile phone %D 2022 %7 14.11.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Health care self-management is important for people living with nondialysis chronic kidney disease (CKD). However, the few available resources are of variable quality. Objective: This work describes the systematic codevelopment of “My Kidneys & Me” (MK&M), a theory-driven and evidence-based digital self-management resource for people with nondialysis CKD, guided by an established process used for the successful development of the diabetes education program MyDESMOND (Diabetes Education and Self-Management for Ongoing and Newly Diagnosed, DESMOND). Methods: A multidisciplinary steering group comprising kidney health care professionals and researchers and specialists in the development of complex interventions and digital health provided expertise in the clinical and psychosocial aspects of CKD, self-management, digital health, and behavior change. A patient and public involvement group helped identify the needs and priorities of MK&M and co-design the resource. MK&M was developed in 2 sequential phases. Phase 1 involved the codevelopment process of the MK&M resource (content and materials), using Intervention Mapping (IM) as a framework. The first 4 IM steps guided the development process: needs assessment was conducted to describe the context of the intervention; intervention outcomes, performance objectives, and behavioral determinants were identified; theory- and evidence-based change methods and practical strategies to deliver change methods were selected; and program components were developed and refined. Phase 2 involved the adoption and adaptation of the existing MyDESMOND digital platform to suit the MK&M resource. Results: The needs assessment identified that individuals with CKD have multiple differing needs and that delivering a self-management program digitally would enable accessible, tailored, and interactive information and support. The intended outcomes of MK&M were to improve and maintain effective self-management behaviors, including physical activity and lifestyle, improve knowledge, promote self-care skills, increase self-efficacy, and enhance well-being. This was achieved through the provision of content and materials designed to increase CKD knowledge and patient activation, reduce health risks, manage symptoms, and improve physical function. Theories and behavior change techniques selected include Self-Management Framework, Capability, Opportunity, Motivation Behavior model components of Behaviour Change Wheel and taxonomy of behavior change techniques, Health Action Process Approach Model, Common Sense Model, and Social Cognitive Theory. The program components developed comprised educational and behavior change sessions, health trackers (eg, monitoring blood pressure, symptoms, and exercise), goal-setting features, and forums for social support. The MyDESMOND digital platform represented an ideal existing platform to host MK&M; thus, the MyDESMOND interface and features were adopted and adapted for MK&M. Conclusions: Applying the IM framework enabled the systematic application of theory, empirical evidence, and practical perspectives in the codevelopment of MK&M content and materials. Adopting and adapting a preexisting platform provided a cost- and time-efficient approach for developing our digital intervention. In the next stage of work, the efficacy of MK&M in increasing patient activation will be tested in a randomized controlled trial. %M 36374538 %R 10.2196/39657 %U https://www.jmir.org/2022/11/e39657 %U https://doi.org/10.2196/39657 %U http://www.ncbi.nlm.nih.gov/pubmed/36374538 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 11 %P e40321 %T Mobile Digital Health Intervention to Promote Nutrition and Physical Activity Behaviors Among Long-term Unemployed in Rural Areas: Protocol for a Randomized Controlled Trial %A Weishaupt,Iris %A Mages-Torluoglu,Jennifer %A Kunze,Christophe %A Weidmann,Christian %A Steinhausen,Kirsten %A Bailer,Anja Christina %+ Care & Technology Lab (IMTT), Faculty of Health, Safety, Society, Furtwangen University, Robert-Gerwig-Platz 1, Furtwangen, 78120, Germany, 49 7723 920 2833, Anja.Bailer@hs-furtwangen.de %K digital health intervention %K behavior changes %K nutrition %K physical activity %K long-term unemployment %K rural areas %K Germany %K mobile phone %D 2022 %7 14.11.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Long-term unemployed have poor nutritional and physical activity statuses, and, therefore, special health promotion needs. Particularly in rural areas, however, they often do not have access to health promotion service. Thus, new promising strategies to improve the health of long-term unemployed are needed. Hence, a digital health intervention to promote nutritional and physical health behaviors was conceived, and the effectiveness of the intervention in combination with face-to-face sessions will be evaluated in a randomized controlled trial. Objective: The aim of this study is to elucidate the effectiveness of a mobile digital health intervention to promote the nutritional and physical activity behaviors of long-term unemployed in the rural areas of Germany. Methods: The 9-week intervention aims to promote nutritional or physical activity behavior by improving drinking habits, increasing the consumption of fruits, vegetables, and whole grains, increasing daily step count, strengthening muscles, and improving endurance. The intervention design is based on the transtheoretical model and is implemented in a mobile app using the MobileCoach open-source platform. The effectiveness of the intervention will be elucidated by a 9-week, 2-armed, parallel-designed trial. Therefore, long-term unemployed will be recruited by employees of the German social sector institutions and randomized either to receive information brochures; the digital intervention in the form of a mobile app; and 3 face-to-face sessions regarding technical support, healthy eating, and physical activity (n=100) or to receive a control treatment consisting of solely the hand over of information brochures (n=100). The effectiveness of the intervention will be assessed using questionnaires at baseline, after 9 weeks in face-to-face appointments, and after a 3-month follow-up period by postal contact. The use of the mobile app will be monitored, and qualitative interviews or focus groups with the participants will be conducted. Incentives of €50 (US $49.7) will be paid to the participants and are tied to the completion of the questionnaires and not to the use of the mobile app or progress in the intervention. Results: The effectiveness of the intervention in promoting the nutritional and physical activity behaviors of long-term unemployed participants will be elucidated. The adherence of the participants to and the acceptance and usability of the mobile device app will be evaluated. Recruitment started in March 2022, and the final publication of the results is expected in the first half of 2023. Conclusions: Positive health-related changes made by the intervention would display the potency of digital health interventions to promote nutritional and physical activity behaviors among long-term unemployed in the rural areas of Germany, which would also contribute to an improved health status of the German population in general. Trial Registration: German Clinical Trials Register DRKS00024805; https://www.drks.de/DRKS00024805 International Registered Report Identifier (IRRID): PRR1-10.2196/40321 %M 36374540 %R 10.2196/40321 %U https://www.researchprotocols.org/2022/11/e40321 %U https://doi.org/10.2196/40321 %U http://www.ncbi.nlm.nih.gov/pubmed/36374540 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 11 %P e42320 %T The Effect of the First UK COVID-19 Lockdown on Users of the Drink Less App: Interrupted Time Series Analysis of Sociodemographic Characteristics, Engagement, and Alcohol Reduction %A Oldham,Melissa %A Perski,Olga %A Loebenberg,Gemma %A Brown,Jamie %A Garnett,Claire %+ Department of Behavioural Science and Health, University College London, 1-19 Torrington Pl, London, WC1E 7HB, United Kingdom, 44 7507712530, m.oldham@ucl.ac.uk %K alcohol reduction %K COVID-19 %K digital intervention %K smartphone app %K United Kingdom %K alcohol %K app %K Drink Less %K engagement %K users %K lockdown %K female %D 2022 %7 10.11.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The first UK COVID-19 lockdown had a polarizing impact on drinking behavior and may have impacted engagement with digital interventions to reduce alcohol consumption. Objective: We examined the effect of lockdown on engagement, alcohol reduction, and the sociodemographic characteristics of users of the popular and widely available alcohol reduction app Drink Less. Methods: This was a natural experiment. The study period spanned 468 days between March 24, 2019, and July 3, 2020, with the introduction of UK lockdown measures beginning on March 24, 2020. Users were 18 years or older, based in the United Kingdom, and interested in drinking less. Interrupted time series analyses using generalized additive mixed models (GAMMs) were conducted for each outcome variable (ie, sociodemographic characteristics, app downloads and engagement levels, alcohol consumption, and extent of alcohol reduction) for existing (downloaded the app prelockdown) and new (downloaded the app during the lockdown) users of the app. Results: Among existing users of the Drink Less app, there were increases in the time spent on the app per day (B=0.01, P=.01), mean units of alcohol recorded per day (B>0.00 P=.02), and mean heavy drinking (>6 units) days (B>0.00, P=.02) during the lockdown. Previous declines in new app downloads plateaued during the lockdown (incidence rate ratio [IRR]=1.00, P=.18). Among new app users, there was an increase in the proportion of female users (B>0.00, P=.04) and those at risk of alcohol dependence (B>0.00, P=.01) and a decrease in the proportion of nonmanual workers (B>–0.00, P=.04). Among new app users, there were step increases in the mean number of alcohol units per day (B=20.12, P=.03), heavy-drinking days (B=1.38, P=.01), and the number of days the app was used (B=2.05, P=.02), alongside a step decrease in the percentage of available screens viewed (B=–0.03, P=.04), indicating users were using less of the intervention components within the app. Conclusions: Following the first UK lockdown, there was evidence of increases in engagement and alcohol consumption among new and existing users of the Drink Less app. %M 36240461 %R 10.2196/42320 %U https://www.jmir.org/2022/11/e42320 %U https://doi.org/10.2196/42320 %U http://www.ncbi.nlm.nih.gov/pubmed/36240461 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 11 %P e38984 %T Addiction Symptom Network of Young Internet Users: Network Analysis %A Lu,Jianxia %A Zhang,Qinhan %A Zhong,Na %A Chen,Jin %A Zhai,Yujia %A Guo,Lei %A Lu,Chunlei %A Chen,Tianzhen %A Jiang,Zhongli %A Zheng,Hui %+ Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 Wan Ping Nan Road, Shanghai, 200030, China, 86 18267908575, zh.dmtr@gmail.com %K internet addiction %K Internet Addiction Test %K network analysis %K adolescents %D 2022 %7 10.11.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: An increasing number of people are becoming addicted to the internet as a result of overuse. The Internet Addiction Test (IAT) is a popular tool for evaluating internet use behaviors. The interaction between different symptoms and the relationship between IAT and clinical diagnostic criteria are not well understood. Objective: This study aimed to explore the core symptoms of internet addiction (IA) and the correlation between different symptoms of the IA symptom network. Network analysis was also conducted to explore the association between the IAT scale and the Diagnostic and Statistical Manual of Mental Disorders–5th edition (DSM-5) criteria for IA. Methods: We recruited 4480 internet users (aged 14-24 years), and they completed the IAT. The final analysis included 63.50% (2845/4480) of the participants after screening the submitted questionnaires. Participants were classified into IA group and non-IA (NIA) group. By using partial correlation with Lasso regularization networks, we identified the core symptoms of IA in each group and compared the group differences in network properties (strength, closeness, and betweenness). Then, we analyzed the symptom networks of the DSM-5 diagnostic criteria and IAT scale for IA. Results: A total of 12.47% (355/2845) of the patients were in the IA group and 87.52% (2490/2845) of the patients were in the NIA group, and both groups were evaluated for the following nodes: IAT_06 (school work suffers; strength=0.511), IAT_08 (job performance suffers; strength=0.531), IAT_15 (fantasize about being on the web; strength=0.474), IAT_17 (fail to stop being on the web; strength=0.526), and IAT_12 (fear about boredom if offline; strength=0.502). The IA groups had a stronger edge between IAT_09 (defensive or secretive about being on the web) and IAT_18 (hidden web time) than the NIA groups. The items in DSM-5 had a strong association with IAT_12 (weight=−0.066), IAT_15 (weight=−0.081), IAT_17 (weight=−0.106), IAT_09 (weight=−0.198), and IAT_18 (weight=−0.052). Conclusions: The internet use symptom network of the IA group is significantly different from that of the NIA group. Nodes IAT_06 (school work affected) and IAT_08 (work performance affected) are the resulting symptoms affected by other symptoms, whereas nodes IAT_12 (fear about boredom if offline), IAT_17 (inability to stop being on the web), and IAT_15 (fantasize about being on the web) are key symptoms that activate other symptoms of IA and are strongly linked to the inability to control the intention to play games in the DSM-5. %M 36355402 %R 10.2196/38984 %U https://www.jmir.org/2022/11/e38984 %U https://doi.org/10.2196/38984 %U http://www.ncbi.nlm.nih.gov/pubmed/36355402 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 11 %P e41721 %T Mental Health Outcomes for Youths With Public Versus Private Health Insurance Attending a Telehealth Intensive Outpatient Program: Quality Improvement Analysis %A Gliske,Kate %A Berry,Katie R %A Ballard,Jaime %A Evans-Chase,Michelle %A Solomon,Phyllis L %A Fenkel,Caroline %+ Charlie Health, 233 E Main St., Suite 401, Bozeman, MT, 59715, United States, 1 952 334 1411, kate.gliske@charliehealth.com %K telehealth %K telepsychiatry %K telemedicine %K intensive outpatient %K remote outpatient %K mental health %K quality improvement %K routine outcome monitoring %K mental health treatment %K patient outcome %K outpatient program %K youth %K young adult %K depression %K suicidal ideation %K health outcome %K outcome monitoring %D 2022 %7 10.11.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: COVID-19 exacerbated a growing mental health crisis among youths and young adults, worsened by a lack of existing in-person options for high-acuity care. The emergence and growth of remote intensive outpatient programs (IOPs) is a solution to overcome geographic limitations to care. However, it remains unclear whether remote IOPs engender equivalent clinical outcomes among youths with public insurance (eg, Medicaid) versus private insurance (eg, commercial) given the disparities found in previous research on place-based treatment in both clinical and engagement outcomes. Objective: This analysis sought to establish, as part of ongoing quality improvement efforts, whether engagement and clinical outcomes among adolescents and young adults attending remote IOP treatment differed between youths with public and those with private insurance. The identification of disparities by payer type was used to inform programmatic decisions within the remote IOP system for which this quality improvement analysis was conducted. Methods: Pearson chi-square analyses and independent 2-tailed t tests were used to establish that the 2 groups defined by insurance type were equivalent on clinical outcomes (depression, suicidal ideation, and nonsuicidal self-injury [NSSI]) at intake and compare changes in clinical outcomes. McNemar chi-square analyses and repeated-measure 2-tailed t tests were used to assess changes in clinical outcomes between intake and discharge in the sample overall. In total, 495 clients who attended the remote IOP for youths and young adults in 14 states participated in ≥7 treatment sessions, and completed intake and discharge surveys between July 2021 and April 2022 were included in the analysis. Results: Overall, the youths and young adults in the remote IOP attended a median of 91% of their scheduled group sessions (mean 85.9%, SD 16.48%) and reported significantly fewer depressive symptoms at discharge (t447=12.51; P<.001). McNemar chi-square tests of change indicated significant reductions from intake to discharge in suicidal ideation (N=470, χ21=104.4; P<.001), with nearly three-quarters of youths who reported active suicidal ideation at intake (200/468, 42.7%) no longer reporting it at discharge (142/200, 71%), and in NSSI (N=430, χ21=40.7; P<.001), with more than half of youths who reported NSSI at intake (205/428, 47.9%) reporting lower self-harm at discharge (119/205, 58%). No significant differences emerged by insurance type in attendance (median public 89%, median private 92%; P=.10), length of stay (t416=−0.35; P=.73), or reductions in clinical outcomes (depressive symptom severity: t444=−0.87 and P=.38; active suicidal ideation: N=200, χ21=0.6 and P=.49; NSSI frequency: t426=−0.98 and P=.33). Conclusions: Our findings suggest that youths and young adults who participated in remote IOP had significant reductions in depression, suicidal ideation, and NSSI. Given access to the same remote high-acuity care, youths and young adults on both public and private insurance engaged in programming at comparable rates and achieved similar improvements in clinical outcomes. %M 36355428 %R 10.2196/41721 %U https://formative.jmir.org/2022/11/e41721 %U https://doi.org/10.2196/41721 %U http://www.ncbi.nlm.nih.gov/pubmed/36355428 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 11 %P e40707 %T Effectiveness of a Web-Based Intervention to Prevent Anxiety in the Children of Parents With Anxiety: Protocol for a Randomized Controlled Trial %A Dunn,Abigail %A Alvarez,James %A Arbon,Amy %A Bremner,Stephen %A Elsby-Pearson,Chloe %A Emsley,Richard %A Jones,Christopher %A Lawrence,Peter %A Lester,Kathryn J %A Majdandžić,Mirjana %A Morson,Natalie %A Perry,Nicky %A Simner,Julia %A Thomson,Abigail %A Cartwright-Hatton,Sam %+ Department of Psychology, University of Sussex, Pevensey 1 Building, Falmer, Brighton, BN1 9QH, United Kingdom, 44 07532077207, ad560@sussex.ac.uk %K anxiety %K parenting %K online %K RCT %K child %K parent %K randomized controlled trial %K youth %K pediatric %K mental health %K mental well-being %K online intervention %K digital intervention %D 2022 %7 10.11.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Anxiety is the most common childhood mental health condition and is associated with impaired child outcomes, including increased risk of mental health difficulties in adulthood. Anxiety runs in families: when a parent has anxiety, their child has a 50% higher chance of developing it themselves. Environmental factors are predominant in the intergenerational transmission of anxiety and, of these, parenting processes play a major role. Interventions that target parents to support them to limit the impact of any anxiogenic parenting behaviors are associated with reduced anxiety in their children. A brief UK-based group intervention delivered to parents within the UK National Health Service led to a 16% reduction in children meeting the criteria for an anxiety disorder. However, this intervention is not widely accessible. To widen access, a 9-module web-based version of this intervention has been developed. This course comprises psychoeducation and home practice delivered through text, video, animations, and practice tasks. Objective: This study seeks to evaluate the feasibility of delivering this web-based intervention and assess its effectiveness in reducing child anxiety symptoms. Methods:  This is the protocol for a randomized controlled trial (RCT) of a community sample of 1754 parents with self-identified high levels of anxiety with a child aged 2-11 years. Parents in the intervention arm will receive access to the web-based course, which they undertake at a self-determined rate. The control arm receives no intervention. Follow-up data collection is at months 6 and months 9-21. Intention-to-treat analysis will be conducted on outcomes including child anxiety, child mental health symptoms, and well-being; parental anxiety and well-being; and parenting behaviors. Results: Funding was received in April 2020, and recruitment started in February 2021 and is projected to end in October 2022. A total of 1350 participants have been recruited as of May 2022. Conclusions: The results of this RCT will provide evidence on the utility of a web-based course in preventing intergenerational transmission of anxiety and increase the understanding of familial anxiety. Trial Registration: ClinicalTrials.gov NCT04755933; https://clinicaltrials.gov/ct2/show/NCT04755933 International Registered Report Identifier (IRRID): DERR1-10.2196/40707 %M 36355406 %R 10.2196/40707 %U https://www.researchprotocols.org/2022/11/e40707 %U https://doi.org/10.2196/40707 %U http://www.ncbi.nlm.nih.gov/pubmed/36355406 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 11 %P e37234 %T Behavior Change Techniques in Digital Health Interventions for Midlife Women: Systematic Review %A Sediva,Hana %A Cartwright,Tina %A Robertson,Claire %A Deb,Sanjoy K %+ Centre for Nutraceuticals, School of Life Sciences, University of Westminster, 115 New Cavendish Street, London, W1B 2HW, United Kingdom, 44 020 7911 5000, hana.sediva@my.westminster.ac.uk %K menopause %K midlife %K women’s health %K lifestyle %K behavior change technique %K BCT %K behavioral intervention %K digital health %K mobile health %K mHealth %K menopausal symptom %K behavior change %K review %K mobile phone %D 2022 %7 9.11.2022 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Digital health interventions are efficacious in health-promoting behaviors (eg, healthy eating and regular physical activity) that mitigate health risks and menopausal symptoms in midlife. However, integrated evidence-based knowledge about the mechanisms of change in these interventions is unclear. Objective: This systematic review aimed to evaluate studies on behavior change techniques (BCTs) and mechanisms of change in digital health interventions aimed at promoting health-enhancing behaviors in midlife women (aged 40-65 years). Methods: A systematic literature search of the electronic databases PubMed, Web of Science, PsycINFO, and Cochrane Central Register of Controlled Trials in the Cochrane Library was conducted. In total, 2 independent reviewers selected the studies for inclusion, extracted data, and completed BCT mapping of eligible studies. The mechanism of action and intervention functions of eligible studies were evaluated using the behavior change wheel framework. Reporting of psychological theory use within these interventions was explored using the Theory Coding Scheme. Mode of delivery, psychological theory, and BCTs were presented as descriptive statistics. Results: In total, 13 interventions (including 1315 women) reviewed used 13 (SD 4.30, range 6-21) BCTs per intervention on average. The “Shaping knowledge” and “Repetition and substitution” behavior change categories were used most frequently, with 92% (12/13) of the interventions implementing at least one of the BCTs from these 2 categories. Only 13.98% (169/1209) of the 93 available BCTs were used, with “Instructions on behaviour” most frequently used (12/13, 92%). The behavior change wheel mapping suggests that half of the intervention content aimed to increase “Capability” (49/98, 50% of the intervention strategies), “Motivation” (41/98, 42%), and “Opportunity” (8/98, 8%). “Behavioural Regulation” was the most frequently used mechanism of action (15/98, 15%), followed by increasing “Knowledge” (13/98, 13%) and “Cognitive and Interpersonal skills” (10/98, 10%). A total of 78% (7/9) of the intervention functions were used in the studies to change behavior, primarily through “Enablement” (60/169, 35.5%), whereas no study used “Restriction” or “Modelling” functions. Although 69% (9/13) of the interventions mentioned a psychological theory or model, most (10/13, 77%) stated or suggested rather than demonstrated the use of a theoretical base, and none reported explicit links between all BCTs within the intervention and the targeted theoretical constructs. Technological components were primarily based on web-based (9/13, 69%) modes of delivery, followed by phone or SMS text message (8/13, 62%) and wearables (7/13, 54%). Conclusions: The findings of this review indicate an overall weak use of theory, low levels of treatment fidelity, insignificant outcomes, and insufficient description of several interventions to support the assessment of how specific BCTs were activated. Thus, the identified limitations in the current literature provide an opportunity to improve the design of lifestyle health-enhancing interventions for women in midlife. Trial Registration: PROSPERO CRD42021259246; https://tinyurl.com/4ph74a9u %M 36350694 %R 10.2196/37234 %U https://mhealth.jmir.org/2022/11/e37234 %U https://doi.org/10.2196/37234 %U http://www.ncbi.nlm.nih.gov/pubmed/36350694 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 11 %P e39122 %T Barriers to and Facilitators of Engaging With and Adhering to Guided Internet-Based Interventions for Depression Prevention and Reduction of Pain-Related Disability in Green Professions: Mixed Methods Study %A Braun,Lina %A Freund,Johanna %A Thielecke,Janika %A Baumeister,Harald %A Ebert,David Daniel %A Titzler,Ingrid %+ Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Lise-Meitner-Str. 16, Ulm, 89081, Germany, 49 731 50 32814, lina.braun@uni-ulm.de %K internet-based intervention %K depression %K chronic pain %K barriers and facilitators %K qualitative research %K uptake %K adherence %K farmers %K gardeners %K foresters %D 2022 %7 9.11.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Internet-based interventions (IBIs) are effective for the prevention and treatment of mental disorders and are valuable additions for improving routine care. However, the uptake of and adherence to IBIs are often limited. To increase the actual use of IBIs, it is important to identify factors for engaging with and adhering to IBIs. Objective: We qualitatively evaluated barriers and facilitators regarding a portfolio of guided IBIs in green professions (farmers, gardeners, and foresters). Methods: Interview participants were selected from 2 randomized controlled trials for either the prevention of depression (Prevention of Depression in Agriculturists [PROD-A]) or the reduction of pain interference (Preventive Acceptance and Commitment Therapy for Chronic Pain in Agriculturists [PACT-A]) in green professions. The intervention group in PROD-A (N=180) participated in an IBI program, receiving access to 1 of 6 symptom-tailored IBIs. The intervention group in PACT-A (N=44) received access to an IBI for chronic pain. Overall, 41 semistructured qualitative interviews were conducted and transcribed verbatim. Barriers and facilitators were identified via inductive qualitative content analysis, with 2 independent coders reaching almost perfect intercoder reliability (Cohen κ=0.92). A quantitative follow-up survey (30/41, 73%) was conducted to validate the results. Subgroup analyses were performed based on intervention characteristics. Results: We identified 42 barriers and 26 facilitators, which we assigned to 4 superordinate categories related to the intervention (20 barriers; 17 facilitators), work (4 barriers; 1 facilitator), individual (13 barriers; 8 facilitators), and technical (5 barriers; 0 facilitators) aspects. Key barriers (identified by at least 50% of the interviewees) were time-consuming work life (29/40, 73%) and time-consuming private life (23/40, 58%). Similarly, the most frequently identified facilitators included presence of motivation, curiosity, interest and perseverance (30/40, 75%), flexible time management at work (25/40, 63%), and support from family and friends (20/40, 50%). Although agreement with barriers in the quantitative follow-up survey was rather low (mean 24%, SD 11%), agreement with facilitators was substantially higher (mean 80%, SD 13%). Differences in agreement rates were found particularly between intervention completers and noncompleters. Completers agreed significantly more often that perceived IBI success; being motivated, curious, interested, and perseverant; and having a persisting level of psychological strain have been facilitating. Noncompleters agreed more often with experiencing the e-coach contact as insufficient and technical problems as hindering for intervention completion. Conclusions: Based on these results, strategies such as customization of modules for more flexible and adaptive use; video chat options with the e-coach; options to facilitate social support by family, friends, or other participants; or using prompts to facilitate training completion can be derived. These approaches could be evaluated in further quantitative research designs in terms of their potential to enhance intervention use in this occupational group. Trial Registration: German Clinical Trials Register DRKS00014000, https://tinyurl.com/3bukfr48; German Clinical Trials Register DRKS0001461, https://tinyurl.com/ebsn4sns %M 36350684 %R 10.2196/39122 %U https://mental.jmir.org/2022/11/e39122 %U https://doi.org/10.2196/39122 %U http://www.ncbi.nlm.nih.gov/pubmed/36350684 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 11 %P e39511 %T A Hybrid Ecological Momentary Compassion–Focused Intervention for Enhancing Resilience in Help-Seeking Young People: Prospective Study of Baseline Characteristics in the EMIcompass Trial %A Paetzold,Isabell %A Schick,Anita %A Rauschenberg,Christian %A Hirjak,Dusan %A Banaschewski,Tobias %A Meyer-Lindenberg,Andreas %A Butz,Sebastian %A Floesser,Chiara %A Schueltke,Leonie %A Boehnke,Jan Rasmus %A Boecking,Benjamin %A Reininghaus,Ulrich %+ Department of Public Mental Health, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, J 5 1, Mannheim, 68159, Germany, 49 62117031930, ulrich.reininghaus@zi-mannheim.de %K mobile health intervention %K mHealth intervention %K digital intervention %K just-in-time adaptive intervention %K JITAI %K blended care %K public mental health %K inclusiveness %K transdiagnostic %K clinical staging %K intervention manual %K mobile phone %D 2022 %7 4.11.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Young people are a target population for mental health–related early intervention and prevention. Although evidence for early intervention is promising, availability of and access to youth mental health services remain limited. Therefore, the development of an evidence-based hybrid intervention is urgently needed. Objective: This study aimed to present a manual for a hybrid intervention, combining an ecological momentary intervention and face-to-face sessions aimed for enhancing resilience in help-seeking young people based on compassion-focused interventions, and explore whether participants’ baseline characteristics are associated with putative mechanisms and outcomes of the EMIcompass intervention. Specifically, we aimed to explore initial signals as to whether participants’ sociodemographic, clinical, and functional characteristics at baseline are associated with putative mechanisms (ie, change in self-compassion, change in emotion regulation, working alliance, training frequency); and whether participants’ sociodemographic, clinical, and functional characteristics, self-compassion, and emotion regulation at baseline are associated with clinical outcomes (ie, psychological distress and general psychopathology at postintervention and 4-week follow-ups) in the experimental condition and obtain first parameter estimates. Methods: We recruited young people aged 14 to 25 years, with psychological distress, Clinical High At-Risk Mental State, or first episodes of severe mental disorder for an exploratory randomized controlled trial with assessments at baseline and postintervention and 4-week follow-ups. A structured manual was developed and optimized based on a pilot study’s manual, a scoping review of existing literature and manuals, exchange with experts, the team’s clinical experience of working with compassion-focused interventions, and the principles of ecological momentary interventions. This analysis focuses on the experimental condition receiving the EMIcompass intervention. Results: A total of 46 young individuals were randomized to the experimental condition. There was evidence for initial signals of effects of age (B=0.11, 95% CI 0.00-0.22), general psychopathology (B=0.08, 95% CI −0.01 to 0.16), and clinical stage (B=1.50, 95% CI 0.06-2.93) on change in momentary self-compassion and change in emotion regulation from baseline to postintervention assessments. There was no evidence for associations of other baseline characteristics (eg, gender, minority status, and level of functioning) and putative mechanisms (eg, overall self-compassion, working alliance, and training frequency). In addition, except for an initial signal for an association of momentary self-compassion at baseline and psychological distress (B=−2.83, 95% CI −5.66 to 0.00), we found no evidence that baseline characteristics related to clinical outcomes. Conclusions: The findings indicated the reach of participants by the intervention largely independent of sociodemographic, clinical, and functional baseline characteristics. The findings need to be confirmed in a definitive trial. Trial Registration: German Clinical Trials Register NDRKS00017265; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017265 International Registered Report Identifier (IRRID): RR2-10.2196/27462 %M 36331526 %R 10.2196/39511 %U https://formative.jmir.org/2022/11/e39511 %U https://doi.org/10.2196/39511 %U http://www.ncbi.nlm.nih.gov/pubmed/36331526 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 11 %P e35508 %T Interactive Remote Patient Monitoring Devices for Managing Chronic Health Conditions: Systematic Review and Meta-analysis %A Leo,Donato Giuseppe %A Buckley,Benjamin J R %A Chowdhury,Mahin %A Harrison,Stephanie L %A Isanejad,Masoud %A Lip,Gregory Y H %A Wright,David J %A Lane,Deirdre A %A , %+ Department of Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Sciences, Faculty of Health and Life Sciences, University of Liverpool, William Henry Duncan Building, 6 West Derby Street, Liverpool, L7 8TX, United Kingdom, 44 01517949334, Deirdre.Lane@liverpool.ac.uk %K chronic condition %K telemonitoring %K telemedicine %K eHealth %K self-monitoring %K systematic review %K meta-analysis %D 2022 %7 3.11.2022 %9 Review %J J Med Internet Res %G English %X Background: Telemedicine is an expanding and feasible approach to improve medical care for patients with long-term conditions. However, there is a poor understanding of patients’ acceptability of this technology and their rate of uptake. Objective: The aim of this study was to systematically review the current evidence on telemonitoring in the management of patients with long-term conditions and evaluate the patients’ uptake and acceptability of this technology. Methods: MEDLINE, Scopus, and CENTRAL (the Cochrane Central Register of Controlled Trials) were searched from the date of inception to February 5, 2021, with no language restrictions. Studies were eligible for inclusion if they reported any of the following outcomes: intervention uptake and adherence; study retention; patient acceptability, satisfaction, and experience using the intervention; changes in physiological values; all-cause and cardiovascular-related hospitalization; all-cause and disease-specific mortality; patient-reported outcome measures; and quality of life. In total, 2 reviewers independently assessed the articles for eligibility. Results: A total of 96 studies were included, and 58 (60%) were pooled for the meta-analyses. Meta-analyses showed a reduction in mortality (risk ratio=0.71, 95% CI 0.56-0.89; P=.003; I2=0%) and improvements in blood pressure (mean difference [MD]=−3.85 mm Hg, 95% CI −7.03 to −0.68; P=.02; I2=100%) and glycated hemoglobin (MD=−0.33, 95% CI −0.57 to −0.09; P=.008; I2=99%) but no significant improvements in quality of life (MD=1.45, 95% CI −0.10 to 3; P=.07; I2=80%) and an increased risk of hospitalization (risk ratio=1.02, 95% CI 0.85-1.23; P=.81; I2=79%) with telemonitoring compared with usual care. A total of 12% (12/96) of the studies reported adherence outcomes, and 9% (9/96) reported on satisfaction and acceptance outcomes; however, heterogeneity in the assessment methods meant that a meta-analysis could not be performed. Conclusions: Telemonitoring is a valid alternative to usual care, reducing mortality and improving self-management of the disease, with patients reporting good satisfaction and adherence. Further studies are required to address some potential concerns regarding higher hospitalization rates and a lack of positive impact on patients’ quality of life. Trial Registration: PROSPERO CRD42021236291; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=236291 %M 36326818 %R 10.2196/35508 %U https://www.jmir.org/2022/11/e35508 %U https://doi.org/10.2196/35508 %U http://www.ncbi.nlm.nih.gov/pubmed/36326818 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 11 %P e40063 %T Validity of the Parsley Symptom Index—an Electronic Patient-Reported Outcomes Measure Designed for Telehealth: Prospective Cohort Study %A Williams,Hants %A Steinberg,Sarah %A Leon,Kendall %A O’Shea,Catherine %A Berzin,Robin %A Hagg,Heather %+ Department of Applied Health Informatics, School of Health Professions, Stony Brook University, 101 Nicolls Rd, Stony Brook, NY, 11794-8200, United States, 1 631 444 2252, hantsawilliams@gmail.com %K telemedicine %K eHealth %K mHealth %K web-based %D 2022 %7 3.11.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Electronic patient-reported outcomes measures (e-PROMs) are a valuable tool for the monitoring and management of chronic conditions over time. However, there are few validated tools available that capture symptoms across body systems in telehealth settings. The Parsley Symptom Index (PSI) is a recently developed symptom assessment for adults with chronic disease in telehealth settings. A previous study demonstrated the feasibility and acceptability of the PSI in a clinical telehealth setting. Objective: The purpose of this study was to assess convergent validity between the PSI and the self-rated health (SRH) item. Methods: This prospective cohort study took place from January 15, 2021, to December 15, 2021, among a sample of 10,519 adult patients at Parsley Health, a subscription-based holistic medical practice. The PSI and the SRH were completed by patients via an online portal. The association between the PSI and SRH was assessed via polyserial and polychoric correlations, while weighted κ scores provided information related to agreement between the PSI and SRH. Results: From 22,748 responses, there were moderate levels of association (polyserial r=0.51; polychoric r=0.52) and agreement (weighted κ=0.46) between the PSI and SRH. In total, 74.13% (n=16,865) of responses between the PSI and SRH were relatively congruent while 36.17% (n=8229) were literally congruent. Conclusions: The PSI demonstrates convergent validity with the SRH for adults with chronic disease in a telehealth setting. This finding further supports the validation of the PSI in a real-world clinical setting. Although it is conceptually similar to the 1-question SRH, the PSI is a 45-item PROM designed to capture quality of life and specific symptoms by body system. Future studies will compare the PSI to multi-item PROMs. %M 36326802 %R 10.2196/40063 %U https://formative.jmir.org/2022/11/e40063 %U https://doi.org/10.2196/40063 %U http://www.ncbi.nlm.nih.gov/pubmed/36326802 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 11 %P e30327 %T Internet-Based Intervention Compared to Brief Intervention for Smoking Cessation in Brazil: Pilot Study %A Machado,Nathalia Munck %A Gomide,Henrique Pinto %A Bernardino,Heder Soares %A Ronzani,Telmo Mota %+ Department of Population Health, University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, 66160, United States, 1 8163287381, nmachado@kumc.edu %K smoking cessation %K internet-based intervention %K digital intervention %K mobile health %K mHealth %K tobacco %K addiction %K public health %K digital intervention %K substance use %D 2022 %7 3.11.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Smoking is still the leading cause of preventable death. Governments and health care providers should make available more accessible resources to help tobacco users stop. Objective: This study describes a pilot longitudinal study that evaluated the efficacy of an internet-based intervention compared to the brief intervention for smoking cessation among Brazilians. Methods: Eligible participants were recruited and randomly allocated to one of the two interventions. Measures were drawn by comparing cessation rates, motivation scores, and sought treatment between groups, assessed 1 and 3 months after the intervention. Inferential analysis was performed to compare the participants’ characteristics, and the intention to treat was calculated. Results: A total of 49 smokers were enrolled in this study (n=25, 51% in the brief intervention group; n=24, 49% in the internet-based intervention group). Mean age was 44.5 (SD 13.3) years; most were male (n=29, 59.2%), had elementary school (n=22, 44.9%), smoked 14.5 cigarettes per day on average (SD 8.6), and had a mean score of 4.65 for nicotine dependence and 5.7 for motivation to quit. Moreover, 35 (71%) participants answered follow-up 1, and 19 (39%) answered follow-up 2. The results showed similar rates of cessation and reduction for both intervention groups. Conclusions: The internet-based intervention was slightly more effective for smoking cessation, while the brief intervention was more effective in reducing the number of cigarettes smoked per day. This difference was small and had no statistical significance even after adjusting for intention-to-treat analysis. These results should be interpreted with caution, especially due to the small sample size. %M 36326817 %R 10.2196/30327 %U https://formative.jmir.org/2022/11/e30327 %U https://doi.org/10.2196/30327 %U http://www.ncbi.nlm.nih.gov/pubmed/36326817 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 11 %P e40364 %T Nurse-led Telehealth Intervention for Rehabilitation (Telerehabilitation) Among Community-Dwelling Patients With Chronic Diseases: Systematic Review and Meta-analysis %A Lee,Athena Yin Lam %A Wong,Arkers Kwan Ching %A Hung,Tommy Tsz Man %A Yan,Jing %A Yang,Shulan %+ School of Nursing, The Hong Kong Polytechnic University, Room, 502, Block GH, 1 Yuk Choi Road, Hung Hom, 000, Hong Kong, 852 34003805, arkers.wong@polyu.edu.hk %K chronic disease %K telerehabilitation %K meta-analysis %K telemedicine %K nurses %K outpatients %D 2022 %7 2.11.2022 %9 Review %J J Med Internet Res %G English %X Background: Chronic diseases are putting huge pressure on health care systems. Nurses are widely recognized as one of the competent health care providers who offer comprehensive care to patients during rehabilitation after hospitalization. In recent years, telerehabilitation has opened a new pathway for nurses to manage chronic diseases at a distance; however, it remains unclear which chronic disease patients benefit the most from this innovative delivery mode. Objective: This study aims to summarize current components of community-based, nurse-led telerehabilitation programs using the chronic care model; evaluate the effectiveness of nurse-led telerehabilitation programs compared with traditional face-to-face rehabilitation programs; and compare the effects of telerehabilitation on patients with different chronic diseases. Methods: A systematic review and meta-analysis were performed using 6 databases for articles published from 2015 to 2021. Studies comparing the effectiveness of telehealth rehabilitation with face-to-face rehabilitation for people with hypertension, cardiac diseases, chronic respiratory diseases, diabetes, cancer, or stroke were included. Quality of life was the primary outcome. Secondary outcomes included physical indicators, self-care, psychological impacts, and health-resource use. The revised Cochrane risk of bias tool for randomized trials was employed to assess the methodological quality of the included studies. A meta-analysis was conducted using a random-effects model and illustrated with forest plots. Results: A total of 26 studies were included in the meta-analysis. Telephone follow-ups were the most commonly used telerehabilitation delivery approach. Chronic care model components, such as nurses-patient communication, self-management support, and regular follow-up, were involved in all telerehabilitation programs. Compared with traditional face-to-face rehabilitation groups, statistically significant improvements in quality of life (cardiac diseases: standard mean difference [SMD] 0.45; 95% CI 0.09 to 0.81; P=.01; heterogeneity: X21=1.9; I2=48%; P=.16; chronic respiratory diseases: SMD 0.18; 95% CI 0.05 to 0.31; P=.007; heterogeneity: X22=1.7; I2=0%; P=.43) and self-care (cardiac diseases: MD 5.49; 95% CI 2.95 to 8.03; P<.001; heterogeneity: X25=6.5; I2=23%; P=.26; diabetes: SMD 1.20; 95% CI 0.55 to 1.84; P<.001; heterogeneity: X24=46.3; I2=91%; P<.001) were observed in the groups that used telerehabilitation. For patients with any of the 6 targeted chronic diseases, those with hypertension and diabetes experienced significant improvements in their blood pressure (systolic blood pressure: MD 10.48; 95% CI 2.68 to 18.28; P=.008; heterogeneity: X21=2.2; I2=54%; P=0.14; diastolic blood pressure: MD 1.52; 95% CI –10.08 to 13.11, P=.80; heterogeneity: X21=11.5; I2=91%; P<.001), and hemoglobin A1c (MD 0.19; 95% CI –0.19 to 0.57 P=.32; heterogeneity: X24=12.4; I2=68%; P=.01) levels. Despite these positive findings, telerehabilitation was found to have no statistically significant effect on improving patients’ anxiety level, depression level, or hospital admission rate. Conclusions: This review showed that telerehabilitation programs could be beneficial to patients with chronic disease in the community. However, better designed nurse-led telerehabilitation programs are needed, such as those involving the transfer of nurse-patient clinical data. The heterogeneity between studies was moderate to high. Future research could integrate the chronic care model with telerehabilitation to maximize its benefits for community-dwelling patients with chronic diseases. Trial Registration: International Prospective Register of Systematic Reviews CRD42022324676; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=324676 %M 36322107 %R 10.2196/40364 %U https://www.jmir.org/2022/11/e40364 %U https://doi.org/10.2196/40364 %U http://www.ncbi.nlm.nih.gov/pubmed/36322107 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 11 %P e38855 %T A Cost-effectiveness Analysis of a Mobile Phone–Based Integrated HIV-Prevention Intervention Among Men Who Have Sex With Men in China: Economic Evaluation %A Yun,Ke %A Yu,Jiaming %A Liu,Changyang %A Zhang,Xinxin %+ Department of Ophthalmology Laboratory, The Fourth Affiliated Hospital of China Medical University, No. 11 Xinhua Road, Shenyang, 110006, China, 86 024 62035015, zhangxinxin@cmu.edu.cn %K cost-effectiveness %K digital intervention %K men who have sex with men %K mathematical model %D 2022 %7 2.11.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Mobile phone–based digital interventions have been shown to be a promising strategy for HIV prevention among men who have sex with men (MSM). Objective: This study aimed to evaluate the cost-effectiveness of a mobile phone–based digital intervention for HIV prevention among MSM in China from the perspective of a public health provider. Methods: The cost-effectiveness of the mobile phone–based digital intervention was estimated for a hypothetical cohort of 10,000 HIV-negative MSM who were followed for 1 year. A model was developed with China-specific data to project the clinical impact and cost-effectiveness of two mobile phone–based digital strategies for HIV prevention among MSM. The intervention group received an integrated behavioral intervention that included 1) individualized HIV infection risk assessment, 2) recommendation of centers testing for HIV and other STIs, 3) free online order of condoms and HIV and syphilis self-test kits and 4) educational materials about HIV/AIDS. The control group was only given educational materials about HIV/AIDS. Outcomes of interest were the number of HIV infections among MSM averted by the intervention, intervention costs, cost per HIV infection averted by the mobile phone–based digital intervention, and quality-adjusted life-years (QALYs). Univariate and multivariate sensitivity analyses were also conducted to examine the robustness of the results. Results: It is estimated that the intervention can prevent 48 MSM from becoming infected with HIV and can save 480 QALYs. The cost of preventing 1 case of HIV infection was US $2599.87, and the cost-utility ratio was less than 0. Sensitivity analysis showed that the cost-effectiveness of the mobile phone–based digital intervention was mainly impacted by the average number of sexual behaviors with each sexual partner. Additionally, the higher the HIV prevalence among MSM, the greater the benefit of the intervention. Conclusions: Mobile phone–based digital interventions are a cost-effective HIV-prevention strategy for MSM and could be considered for promotion and application among high-risk MSM subgroups. %M 36322123 %R 10.2196/38855 %U https://www.jmir.org/2022/11/e38855 %U https://doi.org/10.2196/38855 %U http://www.ncbi.nlm.nih.gov/pubmed/36322123 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 5 %N 4 %P e40614 %T An Internet-Based Parent Training With Telephone Coaching on Managing Disruptive Behavior in Children at Special Family Counseling Centers During the COVID-19 Pandemic: Feasibility Study %A Sourander,Saana %A Sourander,Andre %A Hinkka-Yli-Salomäki,Susanna %A Ristkari,Terja %A Kurki,Marjo %+ Department of Child Psychiatry, University of Turku, Lemminkäisenkatu 3, Teutori 3rd floor, Turku, 20014, Finland, 358 469212562, saana.sourander@utu.fi %K parent training %K disruptive behavior %K child psychopathology %K child functioning %K internet-based %K COVID-19 pandemic %K COVID-19 %K mental health %K psychological well-being %K digital health %K parenting %K telehealth %K behavioral problem %K psychopathology %D 2022 %7 2.11.2022 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: There is growing concern about the short- and long-term impacts that the COVID-19 pandemic will have on the mental health and psychosocial well-being of children and families. There are no existing studies about feasibility and outcomes using internet-based parent training programs with telephone coaching for disruptive behavioral problems in childhood during the COVID-19 pandemic in clinical settings. Objective: This study explored how the Strongest Families Smart Website (SFSW) parent training program, with telephone coaching, provided support during the COVID-19 pandemic at specialist family counseling centers in Helsinki, Finland, when restrictions made face-to-face counseling impossible. This study followed the success of a randomized controlled trial (RCT) and its implementation study of the SFSW parent training program by primary care child health clinics. The aim was to improve parenting skills, so that parents could tackle disruptive behavior by developing positive parent-child relationships. It started in May 2020, when the COVID-19 pandemic was at its height in Finland. Methods: In total, 8 family counseling centers in Helsinki identified 50 referrals aged 3-8 years with high levels of parent-reported disruptive behavioral problems. Child psychopathology and functioning and parental skills and well-being were measured at baseline, posttreatment, and 6 months later using a range of tools. The data were extracted from questionnaires completed by the parents. Results: We found that 44 (88%) of the 50 families completed the whole 11-session parent training program. Most of the children (n=48, 96%) had definitive or severe behavioral problems when they were initially screened by the centers, but with those assessed at the 6-month follow-up (n=45, 90%), this dropped to 58% (n=26). There were significant changes from baseline to 6-month follow-up in most of the child psychopathology measures, including the Child Behavior Checklist-Parent Report Form (CBCL) total score (mean change 16.3, SE 3.0, 95% CI 10.2-22.3; P<.001) and externalizing score (mean change 7.0, SE 1.0, 95% CI 4.9-9.0; P<.001). When parenting skills were measured with the Parenting Scale (PS), they showed significant changes from baseline to 6-month follow-up in total scores (mean change 0.5, SE 0.1, 95% CI 0.4-0.7; P<.001). Parents showed significant change in the stress subscore (mean change 3.9, SE 0.8, 95% CI 2.2-5.6; P<.001). Of the parents who filled in the satisfaction questionnaire (n=45, 90%), 42 (93%) reported high satisfaction in the skills and 44 (98%) in the professionalism of the family coaches. Conclusions: The program proved to be an effective method for improving parenting skills and child psychopathology and functioning. The parents were satisfied with the program, and the dropout rate was exceptionally low. The study shows that the training program could be implemented in specialist clinical settings and during crisis conditions, such as the COVID-19 pandemic. %M 36194895 %R 10.2196/40614 %U https://pediatrics.jmir.org/2022/4/e40614 %U https://doi.org/10.2196/40614 %U http://www.ncbi.nlm.nih.gov/pubmed/36194895 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 11 %P e39912 %T User Engagement Within an Online Peer Support Community (Depression Connect) and Recovery-Related Changes in Empowerment: Longitudinal User Survey %A Smit,Dorien %A Vrijsen,Janna N %A Broekman,Theo %A Groeneweg,Bart %A Spijker,Jan %+ Pro Persona Mental Health Care, Pro Persona Research, Depression Expertise Centre, Nijmeegsebaan 61, Nijmegen, 6525 DX, Netherlands, 31 647074551, d.smit@propersona.nl %K depression %K online peer support community %K internet support group %K experiential knowledge %K self-management %K empowerment %K user engagement %K longitudinal user survey %D 2022 %7 2.11.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The chronic nature of depression and limited availability of evidence-based treatments emphasize the need for complementary recovery-oriented services, such as peer support interventions (PSIs). Peer support is associated with positive effects on clinical and personal recovery from mental illness, but little is known about the processes of engagement that foster change, and studies targeting individuals with depression specifically are limited. Objective: This study aimed to evaluate whether the level of user engagement, assessed on several dimensions, in an online peer support community for individuals with depression promotes empowerment and the use of self-management strategies and reduces symptom severity and disability. Methods: In a longitudinal survey conducted from June 2019 to September 2020, we analyzed the data of the users of Depression Connect (DC), an online peer support community hosted by the Dutch Patient Association for Depression and the Pro Persona Mental Health Care institute, on measures of empowerment, self-management, depression, and disability. Of the 301 respondents, 49 (16.3%) respondents completed the survey again after 3 months and 74 (24.6%) respondents, after 6 months. Analysis of 3 parameters (ie, total time spent on the platform, number of page views, and number of posts) derived from their data logs yielded 4 engagement profiles. Linear mixed models were fitted to determine whether the outcomes had significantly changed over time and differed for the various profiles. Results: Baseline engagement with the online peer support community was “very low” (177/301, 58.8%) or “low” (87/301, 28.9%) for most of the participants, with few showing “medium” (30/301, 9.9%) or “high” engagement patterns (7/301, 2.3%), while user profiles did not differ in demographic and clinical characteristics. Empowerment, self-management, depressive symptoms, and disability improved over time, but none were associated with the intensity or nature of user engagement. Conclusions: With most DC members showing very low to low engagement and only a few being identified as high-engaged users, it is likely that this flexibility in use frequency is what provides value to online PSI users. In other more formal supportive environments for depression, a certain level of engagement is predetermined either by their organizational or by their societal context; at DC, users can adapt the intensity and nature of their engagement to their current needs on their personal road to recovery. This study added to the current knowledge base on user engagement for PSIs because previous studies targeting depression with an online format focused on active users, precluding passive and flexible engagement. Future studies should explore the content and quality of the interactions in online PSIs to identify optimal user engagement as a function of current, self-reported clinical parameters and reasons to engage in the PSI. %M 36322110 %R 10.2196/39912 %U https://formative.jmir.org/2022/11/e39912 %U https://doi.org/10.2196/39912 %U http://www.ncbi.nlm.nih.gov/pubmed/36322110 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 11 %P e36496 %T Cost-Utility and Cost-effectiveness of MoodSwings 2.0, an Internet-Based Self-management Program for Bipolar Disorder: Economic Evaluation Alongside a Randomized Controlled Trial %A Chatterton,Mary Lou %A Lee,Yong Yi %A Berk,Lesley %A Mohebbi,Mohammadreza %A Berk,Michael %A Suppes,Trisha %A Lauder,Sue %A Mihalopoulos,Cathrine %+ Institute for Health Transformation, Deakin University, Locked Bag 20001, Geelong, 3220, Australia, 61 03 52278409, mchatter@deakin.edu.au %K economic evaluation %K cost-effectiveness %K cost-utility %K clinical trial %K bipolar disorder %K psychoeducation %K cognitive behavioral therapy %K internet intervention %K mania %K depression %K psychiatry %K neuroscience %K mental disorders %D 2022 %7 1.11.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Internet-delivered psychosocial interventions can overcome barriers to face-to-face psychosocial care, but limited evidence supports their cost-effectiveness for people with bipolar disorders (BDs). Objective: This study aimed to conduct within-trial cost-effectiveness and cost-utility analyses of an internet-based intervention for people with BD, MoodSwings 2.0, from an Australian health sector perspective. Methods: MoodSwings 2.0 included an economic evaluation alongside an international, parallel, and individually stratified randomized controlled trial comparing an internet-based discussion forum (control; group 1), a discussion forum plus internet-based psychoeducation (group 2), and a discussion forum plus psychoeducation and cognitive behavioral tools (group 3). The trial enrolled adults (aged 21 to 65 years) with a diagnosis of BD assessed by telephone using a structured clinical interview. Health sector costs included intervention delivery and additional health care resources used by participants over the 12-month trial follow-up. Outcomes included depression symptoms measured by the Montgomery-Åsberg Depression Rating Scale (MADRS; the trial primary outcome) and quality-adjusted life years (QALYs) calculated using the short-form 6-dimension instrument derived from the 12-item version of the short-form health survey. Average incremental cost-effectiveness (cost per MADRS score) and cost-utility (cost per QALY) ratios were calculated using estimated mean differences between intervention and control groups from linear mixed effects models in the base case. Results: In total, 304 participants were randomized. Average health sector cost was lowest for group 2 (Aus $9431, SD Aus $8540; Aus $1=US $0.7058) compared with the control group (Aus $15,175, SD Aus $17,206) and group 3 (Aus $15,518, SD Aus $30,523), but none was statistically significantly different. The average QALYs were not significantly different among the groups (group 1: 0.627, SD 0.062; group 2: 0.618, SD 0.094; and group 3: 0.622, SD 0.087). The MADRS scores were previously shown to differ significantly between group 2 and the control group at all follow-up time points (P<.05). Group 2 was dominant (lower costs and greater effects) compared with the control group for average incremental cost per point decrease in MADRS score over 12 months (95% CI dominated to Aus $331). Average cost per point change in MADRS score for group 3 versus the control group was dominant (95% CI dominant to Aus $22,585). Group 2 was dominant (95% CI Aus $43,000 to dominant) over the control group based on lower average health sector cost and average QALY benefit of 0.012 (95% CI –0.009 to 0.033). Group 3, compared with the control group, had an average incremental cost-effectiveness ratio of dominant (95% CI dominated to Aus $19,978). Conclusions: Web-based psychoeducation through MoodSwings 2.0 has the potential to be a cost-effective intervention for people with BD. Additional research is needed to understand the lack of effectiveness for the addition of cognitive behavioral tools with the group 3 intervention. %M 36318243 %R 10.2196/36496 %U https://mental.jmir.org/2022/11/e36496 %U https://doi.org/10.2196/36496 %U http://www.ncbi.nlm.nih.gov/pubmed/36318243 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 10 %P e41306 %T Racial and Ethnic Differences in Outcomes of a 12-Week Digital Rehabilitation Program for Musculoskeletal Pain: Prospective Longitudinal Cohort Study %A Scheer,Justin %A Costa,Fabíola %A Molinos,Maria %A Areias,Anabela %A Janela,Dora %A Moulder,Robert G %A Lains,Jorge %A Bento,Virgílio %A Yanamadala,Vijay %A Cohen,Steven P %A Correia,Fernando Dias %+ Sword Health, Inc, 13937 Sprague Lane, Suite 100, Draper, UT, 84020, United States, 1 385 308 8034, fcorreia@swordhealth.com %K physical therapy %K telerehabilitation %K digital therapy %K eHealth %K telehealth %K musculoskeletal conditions %K race %K ethnicity %K pain %K diversity %K equity %K mobile phone %D 2022 %7 31.10.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Musculoskeletal (MSK) pain disproportionately affects people from different ethnic backgrounds through higher burden and less access to care. Digital care programs (DCPs) can improve access and help reduce inequities. However, the outcomes of such programs based on race and ethnicity have yet to be studied. Objective: We aimed to assess the impact of race and ethnicity on engagement and outcomes in a multimodal DCP for MSK pain. Methods: This was an ad hoc analysis of an ongoing decentralized single-arm investigation into engagement and clinical-related outcomes after a multimodal DCP in patients with MSK conditions. Patients were stratified by self-reported racial and ethnic group, and their engagement and outcome changes between baseline and 12 weeks were compared using latent growth curve analysis. Outcomes included program engagement (number of sessions), self-reported pain scores, likelihood of surgery, Generalized Anxiety Disorder 7-item scale, Patient Health Questionnaire 9-item, and Work Productivity and Activity Impairment. A minimum clinically important difference (MCID) of 30% was calculated for pain, and multivariable logistic regression was performed to evaluate race as an independent predictor of meeting the MCID. Results: A total of 6949 patients completed the program: 65.5% (4554/6949) of them were non-Hispanic White, 10.8% (749/6949) were Black, 9.7% (673/6949) were Asian, 9.2% (636/6949) were Hispanic, and 4.8% (337/6949) were of other racial or ethnic backgrounds. The population studied was diverse and followed the proportions of the US population. All groups reported high engagement and satisfaction, with Hispanic and Black patients ranking first among satisfaction despite lower engagement. Black patients had a higher likelihood to drop out (odds ratio [OR] 1.19, 95% CI 1.01-1.40, P=.04) than non-Hispanic White patients. Hispanic and Black patients reported the highest level of pain, surgical intent, work productivity, and impairment in activities of daily living at baseline. All race groups showed a significant improvement in all outcomes, with Black and Hispanic patients reporting the greatest improvements in clinical outcomes. Hispanic patients also had the highest response rate for pain (75.8%) and a higher OR of meeting the pain MCID (OR 1.74, 95% CI 1.24-2.45, P=.001), when compared with non-Hispanic White patients, independent of age, BMI, sex, therapy type, education level, and employment status. No differences in mental health outcomes were found between race and ethnic groups. Conclusions: This study advocates for the utility of a DCP in improving access to MSK care and promoting health equity. Engagement and satisfaction rates were high in all the groups. Black and Hispanic patients had higher MSK burden at baseline and lower engagement but also reported higher improvements, with Hispanic patients presenting a higher likelihood of pain improvement. %M 36189963 %R 10.2196/41306 %U https://www.jmir.org/2022/10/e41306 %U https://doi.org/10.2196/41306 %U http://www.ncbi.nlm.nih.gov/pubmed/36189963 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 10 %P e36134 %T Interventions Including Smart Technology Compared With Face-to-face Physical Activity Interventions in Older Adults: Systematic Review and Meta-analysis %A D'Amore,Cassandra %A Reid,Julie C %A Chan,Matthew %A Fan,Samuel %A Huang,Amanda %A Louie,Jonathan %A Tran,Andy %A Chauvin,Stephanie %A Beauchamp,Marla K %+ School of Rehabilitation Science, McMaster University, 1400 Main Street West, Institute for Applied Health Sciences Building, Hamilton, ON, L8S 1C7, Canada, 1 905 525 9140 ext 21732, beaucm1@mcmaster.ca %K aging %K exercise %K mobile health %K mHealth %K wearables %K mobile phone %D 2022 %7 31.10.2022 %9 Review %J J Med Internet Res %G English %X Background: This is a systematic review of randomized controlled trials and a meta-analysis comparing smart technology with face-to-face physical activity (PA) interventions in community-dwelling older adults (mean age 60 years). Objective: This study aims to determine the effect of interventions including smart technology components compared with face-to-face PA interventions on PA and physical function in older adults. The secondary outcomes are depression, anxiety, and health-related quality of life. Methods: We searched MEDLINE, Embase, CINAHL, and AMED electronic databases from inception to February 2021. Two independent reviewers screened titles, abstracts, and full texts and performed data extraction and risk of bias assessments using the Cochrane risk of bias tool. The Grading of Recommendations Assessment, Development and Evaluation was used to evaluate the quality of the evidence. We provided a narrative synthesis on all included studies and, where possible, performed meta-analyses for similar outcomes. Results: This review included 19 studies with a total of 3455 participants. Random effects meta-analyses showed that interventions with smart technology components resulted in improved step count (mean difference 1440 steps, 95% CI 500-2390) and total PA (standardized mean difference 0.17, 95% CI 0.02-0.32) compared with face-to-face alone. There was no difference between groups in terms of the measures of physical function. Smart technology alone did not show significant differences between groups in any outcome. The quality of the evidence was very low based on the Grading of Recommendations Assessment, Development and Evaluation criteria. Conclusions: Interventions that include smart technology may improve daily step counts by an average of 1440 steps in community-dwelling older adults; however, the quality of the evidence was very low. Future studies are needed to improve the certainty of these results. Trial Registration: PROSPERO CRD42020135232; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=135232 %M 36315229 %R 10.2196/36134 %U https://www.jmir.org/2022/10/e36134 %U https://doi.org/10.2196/36134 %U http://www.ncbi.nlm.nih.gov/pubmed/36315229 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 10 %P e40268 %T Long-term Effectiveness and Predictors of Transdiagnostic Internet-Delivered Cognitive Behavioral Therapy for Emotional Disorders in Specialized Care: Secondary Analysis of a Randomized Controlled Trial %A González-Robles,Alberto %A Roca,Pablo %A Díaz-García,Amanda %A García-Palacios,Azucena %A Botella,Cristina %+ Department of Psychology and Sociology, Universidad de Zaragoza, Atarazanas 4, Teruel, 44003, Spain, 34 978618154 ext 861154, gonzaleza@unizar.es %K transdiagnostic %K anxiety %K depression %K long term %K predictors %D 2022 %7 31.10.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Transdiagnostic internet-delivered cognitive behavioral therapy (iCBT) for emotional disorders has been shown to be effective in specialized care in the short term. However, less is known about its long-term effects in this specific setting. In addition, predictors of long-term effectiveness may help to identify what treatments are more suitable for certain individuals. Objective: This study aimed to analyze the long-term effectiveness of transdiagnostic iCBT compared with that of treatment as usual (TAU) in specialized care and explore predictors of long-term effectiveness. Methods: Mixed models were performed to analyze the long-term effectiveness and predictors of transdiagnostic iCBT (n=99) versus TAU (n=101) in public specialized mental health care. Outcomes included symptoms of depression and anxiety, health-related quality of life (QoL), behavioral inhibition and behavioral activation, comorbidity, and diagnostic status (ie, loss of principal diagnosis) from baseline to 1-year follow-up. Sociodemographic characteristics (sex, age, and education) and clinical variables (principal diagnosis, comorbidity, and symptom severity at baseline) were selected as predictors of long-term changes. Results: Compared with baseline, transdiagnostic iCBT was more effective than TAU in improving symptoms of depression (b=–4.16, SE 1.80, 95% CI –7.68 to –0.67), health-related QoL (b=7.63, SE 3.41, 95% CI 1.00-14.28), diagnostic status (b=–0.24, SE 0.09, 95% CI –1.00 to –0.15), and comorbidity at 1-year follow-up (b=–0.58, SE 0.22, 95% CI –1.00 to –0.15). From pretreatment assessment to follow-up, anxiety symptoms improved in both transdiagnostic iCBT and TAU groups, but no significant differences were found between the groups. Regarding the predictors of the long-term effectiveness of transdiagnostic iCBT compared with that of TAU, higher health-related QoL at follow-up was predicted by a baseline diagnosis of anxiety, male sex, and the use of psychiatric medication; fewer comorbid disorders at follow-up were predicted by older age and higher baseline scores on health-related QoL; and fewer depressive symptoms at follow-up were predicted by baseline diagnosis of depression. However, this pattern was not observed for baseline anxiety diagnoses and anxiety symptoms. Conclusions: The results suggest that transdiagnostic iCBT is more effective than TAU to target depressive symptoms among patients with emotional disorders. Anxiety symptoms remained stable at 1-year follow-up, with no differences between the groups. Results on predictors suggest that some groups of patients may obtain specific gains after transdiagnostic iCBT. Specifically, and consistent with the literature, patients with baseline depression improved their depression scores at follow-up. However, this pattern was not found for baseline anxiety disorders. More studies on the predictor role of sociodemographic and clinical variables in long-term outcomes of transdiagnostic iCBT are warranted. Future studies should focus on studying the implementation of transdiagnostic iCBT in Spanish public specialized mental health care. Trial Registration: ClinicalTrials.gov NCT02345668; https://clinicaltrials.gov/ct2/show/NCT02345668 %M 36315227 %R 10.2196/40268 %U https://mental.jmir.org/2022/10/e40268 %U https://doi.org/10.2196/40268 %U http://www.ncbi.nlm.nih.gov/pubmed/36315227 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 10 %P e42216 %T Incentives and Reminders to Improve Long-term Medication Adherence (INMIND): Protocol for a Pilot Randomized Controlled Trial %A Stecher,Chad %A Ghai,Ishita %A Lunkuse,Lillian %A Wabukala,Peter %A Odiit,Mary %A Nakanwagi,Agnes %A Linnemayr,Sebastian %+ College of Health Solutions, Arizona State University, 500 N 3rd Street, Phoenix, AZ, 85004, United States, 1 6024960957, chad.stecher@asu.edu %K medication adherence %K HIV %K antiretroviral therapy %K habit formation %K routines %K behavioral economics %D 2022 %7 31.10.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Nonadherence to antiretroviral therapy (ART) among people living with HIV is a crucial barrier to attaining viral suppression globally. Existing behavioral interventions have successfully increased ART adherence, but typically show only short-term impact that dissipates after the interventions are withdrawn. Objective: This study aims to test the feasibility, acceptability, and preliminary efficacy of a novel intervention that uses SMS text messages and conditional incentives to support ART initiators in establishing pill-taking habits. Methods: A sample of 150 participants aged ≥18 years who have initiated ART in the preceding 3 months will be recruited from Mildmay Uganda in Kampala, Uganda. All (150/150, 100%) participants will be educated on the anchoring strategy and will choose an existing routine to pair with their daily ART adherence from a set of 3 suggested routines: getting dressed in the morning, eating breakfast, or eating dinner. Then, participants will be randomized to receive either usual care (control group: 50/150, 33.3%) or 1 of the 2 interventions delivered over 3 months: daily SMS text message reminders to follow their chosen anchoring plan (messages group; treatment group 1: 50/150, 33.3%) or daily SMS text messages and incentives conditional on taking their ART medication around the time of their chosen anchor (incentives group; treatment group 2: 50/150, 33.3%). Long-term ART adherence will be evaluated for 6 months after the intervention, and survey assessments will be conducted at baseline, 3 months, and 9 months. Outcomes include feasibility and acceptability measures and intervention efficacy outcomes defined by electronically measured mean medication adherence during the intervention and during the 6 months after the intervention, along with a measure of routine ART adherence based on taking medications around the time of participants’ anchor during the intervention and during the 6 months after intervention. Results: As of February 18, 2022, recruitment was completed. A total of 150 participants were recruited, and data collection is expected to end in December of 2022. Final results are expected to be submitted for publication by April 2023. Conclusions: This study is the first to use behavioral economics–based interventions in combination with the anchoring strategy to improve long-term ART adherence among treatment initiators. We hypothesize that the combination of SMS text message reminders and incentives will increase participants’ use of their anchoring strategy, and thus medication adherence will be better maintained after the intervention ends in our intervention groups relative to the control group that uses only the anchoring strategy. Results of this pilot study will help to refine this combined intervention approach for testing at scale and broaden our understanding of the habit formation process. Trial Registration: ClinicalTrials.gov NCT05131165; https://clinicaltrials.gov/ct2/show/NCT05131165 International Registered Report Identifier (IRRID): DERR1-10.2196/42216 %M 36315224 %R 10.2196/42216 %U https://www.researchprotocols.org/2022/10/e42216 %U https://doi.org/10.2196/42216 %U http://www.ncbi.nlm.nih.gov/pubmed/36315224 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 10 %P e41899 %T The Effect of an App-Based Home Exercise Program on Self-reported Pain Intensity in Unspecific and Degenerative Back Pain: Pragmatic Open-label Randomized Controlled Trial %A Weise,Hannes %A Zenner,Benedikt %A Schmiedchen,Bettina %A Benning,Leo %A Bulitta,Michael %A Schmitz,Daniel %A Weise,Kuno %+ Institute for Occupational Medicine, Social Medicine and Health Services Research, University Hospital Tübingen, Eberhard-Karls-University Tübingen, Hoppe-Seyler-Straße 3, Tübingen, 72076, Germany, 49 1727368909, hannes.weise@med.uni-tuebingen.de %K back pain %K musculoskeletal health %K primary care %K exercise therapy %K digital health %K mobile health %K mHealth %K digital therapeutic %K mobile phone %D 2022 %7 28.10.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The recommended first-line treatment for unspecific and degenerative back pain consists of movement exercises and patient education. Objective: Using a pragmatic, randomized controlled trial, we evaluated the effectiveness of a digital home exercise program on self-reported pain intensity compared with the standard of care for physiotherapy. Methods: Participant recruitment was based on newspaper advertisements and a consecutive on-site assessment for eligibility and enrollment. Participants with unspecific and degenerative back pain aged ≥18 years were randomly assigned in a 1:1 ratio to receive a 12-week stand-alone digital home exercise program or physiotherapy. The digital home exercise program included 4 exercises daily, while physiotherapy included 6 to 12 sessions, depending on the severity of symptoms. The primary outcome was pain, which was assessed using a verbal numerical rating scale. The clinical relevance of pain reduction was assessed using the following thresholds: improvement of at least 1.4 points on the verbal numerical rating scale and a pain reduction of at least 30%. Results: During the study period, 108 participants were assigned to the intervention group and 105 participants to the control group. The mean difference in pain scores between the 2 groups at 12 weeks was −2.44 (95% CI −2.92 to −1.95; P<.01) in favor of the intervention group. The group receiving the digital therapeutic achieved a clinically relevant reduction in pain over the course of the study (baseline vs 12 weeks), with a mean change of −3.35 (SD 2.05) score points or −53.1% (SD 29.5). By contrast, this change did not reach clinical relevance in the control group (mean −0.91, SD 1.5; −14.6%, SD 25.3). Retention rates of 89.9% in the intervention group and 97.3% in the control group were maintained throughout the study. Conclusions: The use of the app-based home exercise program led to a significant and clinically relevant reduction in pain intensity throughout the 12-week duration of the program. The intervention studied showed superior improvement in self-reported pain intensity when compared with the standard of care. Given the great demand for standard physiotherapy for unspecific and degenerative back pain, digital therapeutics are evolving into a suitable therapeutic option that can overcome the limitations of access and availability of conventional modes of health care delivery into this spectrum of indications. However, further independent evaluations are required to support the growing body of evidence on the effectiveness of digital therapeutics in real-world care settings. Trial Registration: German Clinical Trials Register DRKS00022781; https://tinyurl.com/hpdraa89 %M 36215327 %R 10.2196/41899 %U https://www.jmir.org/2022/10/e41899 %U https://doi.org/10.2196/41899 %U http://www.ncbi.nlm.nih.gov/pubmed/36215327 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 10 %P e36049 %T Telehealth Movement-to-Music to Increase Physical Activity Participation Among Adolescents With Cerebral Palsy: Pilot Randomized Controlled Trial %A Lai,Byron %A Vogtle,Laura %A Young,Raven %A Craig,Mary %A Kim,Yumi %A Gowey,Marissa %A Swanson-Kimani,Erin %A Davis,Drew %A Rimmer,James H %+ Division of Pediatric Rehabilitation Medicine, Department of Pediatrics, University of Alabama at Birmingham, 1600 7th Avenue South, 5 Dearth, McWane 5601, Birmingham, AL, 35209, United States, 1 205 638 9790 ext 8, blai@uabmc.edu %K exercise %K developmental disability %K cerebral palsy %K telemedicine %K telerehabilitation %K therapy %K mobile phone %D 2022 %7 28.10.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Adolescents with cerebral palsy (CP) who have mobility limitations have almost no access to inexpensive and enjoyable home-based programs that can be disseminated on a large scale to help them independently manage their health through participation in leisure-time physical activity (LTPA). Objective: The primary aim of this study was to determine the preliminary efficacy of the early adoption phase of an adult Movement-to-Music (M2M) program with behavioral telecoaching for increasing LTPA and activity participation compared with a waitlist control group in adolescents with CP. The secondary aim was to explore the effects of the program on perceived levels of pain and fatigue. The tertiary aim was to qualitatively evaluate the factors that influenced adherence and develop a theory that would inform the development of a more targeted M2M telehealth program for this group. Methods: This randomized controlled trial piloted a 4-week M2M program with weekly behavioral telecoaching among 58 adolescents with CP who walked or used wheelchairs. The participants were randomized into one of 2 groups: M2M or control, which maintained their daily activities. M2M included videos that participants were asked to complete 3 times each week at home (asynchronous training). Adherence to video minutes was objectively measured using cloud-based analytics. Changes in activity and LTPA participation were measured before and after the intervention using the Children’s Assessment of Participation and Enjoyment total domain scores and active physical recreation domain scores, respectively. Perceived pain and fatigue were measured using the National Institutes of Health Neuro-QoL short forms. The changes in scores were compared between the groups using analysis of covariance. A grounded theory approach was used to analyze one-on-one interviews, coaching notes, and feedback surveys. Results: A total of 58 people were enrolled, of which 49 (84%) completed the primary outcome follow-up assessment. The mean adherence to the prescribed exercise video minutes across all 4 weeks was 68%, starting from 90% in week 1 and gradually declining to 43% in week 4. Mean adherence to coaching calls was 91%. Analysis of covariance revealed a statistically significant difference between the pre- to postchange scores for Children’s Assessment of Participation and Enjoyment Active Physical Recreation–Intensity domain scores in favor of the intervention group (F1,47=8.76; P=.005; effect size=0.17, also known as volume of LTPA). The qualitative findings highlighted 5 critical factors that influenced participants’ adherence to the program: caregiver support, video elements, suitable exercises, music, and behavioral coaching. Conclusions: This project determined that adolescents with CP responded well to an M2M telehealth program that could enhance their LTPA levels. This paper describes a theory in which adherence to a telehealth LTPA program can be optimized through functional and age-specific modifications for adolescents with CP. Trial Registration: ClinicalTrials.gov NCT04264390; https://clinicaltrials.gov/ct2/show/NCT04264390 %M 36306154 %R 10.2196/36049 %U https://formative.jmir.org/2022/10/e36049 %U https://doi.org/10.2196/36049 %U http://www.ncbi.nlm.nih.gov/pubmed/36306154 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 10 %P e39689 %T Barriers to and Facilitators of Using eHealth to Support Gestational Diabetes Mellitus Self-management: Systematic Literature Review of Perceptions of Health Care Professionals and Women With Gestational Diabetes Mellitus %A Safiee,Ladan %A Rough,Daniel John %A Whitford,Heather %+ School of Science and Engineering, University of Dundee, Queen Mother Building, Dundee, DD1 4HN, United Kingdom, 44 01382 383000, drough001@dundee.ac.uk %K gestational diabetes mellitus %K GDM %K gestational diabetes %K self-management %K eHealth %D 2022 %7 27.10.2022 %9 Review %J J Med Internet Res %G English %X Background: Gestational diabetes mellitus (GDM) is one of the most common medical complications during pregnancy. eHealth technologies are proving to be successful in supporting the self-management of medical conditions. Digital technologies have the potential to improve GDM self-management. Objective: The primary objective of this systematic literature review was to identify the views of health professionals (HPs) and women with GDM regarding the use of eHealth for GDM self-management. The secondary objective was to investigate the usability and user satisfaction levels when using these technologies. Methods: Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) approach, the search included primary papers in English on the evaluation of technology to support self-management of GDM from January 2008 to September 2021 using MEDLINE, CINAHL, Embase, ACM, and IEEE databases. The lists of references from previous systematic literature reviews, which were related to technology and GDM, were also examined for primary studies. Papers with qualitative, quantitative, and mixed methodologies were included and evaluated. The selected papers were assessed for quality using the Cochrane Collaboration tool, National Institute for Health and Care Excellence clinical guidelines, Critical Appraisal Skills Programme Qualitative Checklist, and McGill University Mixed Methods Appraisal Tool. NVivo (QSR International) was used to extract qualitative data, which were subjected to thematic analysis. Narrative synthesis was used to analyze the quantitative data. Results: A total of 26 papers were included in the review. Of these, 19% (5/26) of studies used quantitative research methodologies, 19% (5/26) used qualitative methods, and 62% (16/26) used mixed methods. In all, 4 themes were identified from the qualitative data: the benefits of using technology, engagement with people via technology, the usability of technology, and discouragement factors for the use of technology. The thematic analysis revealed a vast scope of challenges and facilitators in the use of GDM self-management systems. The challenges included usability aspects of the system, technical problems, data privacy, lack of emotional support, the accuracy of reported data, and adoption of the system by HPs. Convenience, improved GDM self-management, peer support, increased motivation, increased independence, and consistent monitoring were facilitators to use these technologies. Quantitative data showed that there is potential for improving the usability of the GDM self-management systems. It also showed that convenience, usefulness, increasing motivation for GDM self-management, helping with GDM self-management, and being monitored by HPs were facilitators to use the GDM self-management systems. Conclusions: This novel systematic literature review shows that HPs and women with GDM encountered some challenges in using GDM self-management systems. The usability of GDM systems was the primary challenge derived from qualitative and quantitative results, with convenience, consistent monitoring, and optimization of GDM self-management emerging as important facilitators. %M 36301613 %R 10.2196/39689 %U https://www.jmir.org/2022/10/e39689 %U https://doi.org/10.2196/39689 %U http://www.ncbi.nlm.nih.gov/pubmed/36301613 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 10 %P e38624 %T Effectiveness of Computerized Cognitive Training in Delaying Cognitive Function Decline in People With Mild Cognitive Impairment: Systematic Review and Meta-analysis %A Li,Ran %A Geng,Jiawei %A Yang,Runze %A Ge,Yumeng %A Hesketh,Therese %+ Institute for Global Health, University College London, 30 Guilford Street, London, WC1N 1EH, United Kingdom, 44 20 7242 9789, t.hesketh@ucl.ac.uk %K computerized cognitive training %K mild cognitive impairment %D 2022 %7 27.10.2022 %9 Review %J J Med Internet Res %G English %X Background: With no current cure for mild cognitive impairment (MCI), delaying its progression could significantly reduce the disease burden and improve the quality of life for patients with MCI. Computerized cognitive training (CCT) has recently become a potential instrument for improvement of cognition. However, the evidence for its effectiveness remains limited. Objective: This systematic review aims to (1) analyze the efficacy of CCT on cognitive impairment or cognitive decline in patients with MCI and (2) analyze the relationship between the characteristics of CCT interventions and cognition-related health outcomes. Methods: A systematic search was performed using MEDLINE, Cochrane, Embase, Web of Science, and Google Scholar. Full texts of randomized controlled trials of CCT interventions in adults with MCI and published in English language journals between 2010 and 2021 were included. Overall global cognitive function and domain-specific cognition were pooled using a random-effects model. Sensitivity analyses were performed to determine the reasons for heterogeneity and to test the robustness of the results. Subgroup analyses were performed to identify the relationship between the characteristics of CCT interventions and cognition-related effectiveness. Results: A total of 18 studies with 1059 participants were included in this review. According to the meta-analysis, CCT intervention provided a significant but small increase in global cognitive function compared to that in the global cognitive function of the control groups (standardized mean difference=0.54, 95% CI 0.35-0.73; I2=38%). CCT intervention also resulted in a marginal improvement in domain-specific cognition compared to that in the control groups, with moderate heterogeneity. Subgroup analyses showed consistent improvement in global cognitive behavior in the CCT intervention groups. Conclusions: This systematic review suggests that CCT interventions could improve global cognitive function in patients with MCI. Considering the relatively small sample size and the short treatment duration in all the included studies, more comprehensive trials are needed to quantify both the impact of CCT on cognitive decline, especially in the longer term, and to establish whether CCT should be recommended for use in clinical practice. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42021278884; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=278884 %M 36301590 %R 10.2196/38624 %U https://www.jmir.org/2022/10/e38624 %U https://doi.org/10.2196/38624 %U http://www.ncbi.nlm.nih.gov/pubmed/36301590 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 10 %P e38480 %T A Tailored Gender-Sensitive mHealth Weight Loss Intervention (I-GENDO): Development and Process Evaluation %A Pape,Magdalena %A Färber,Tanja %A Seiferth,Caroline %A Roth,Tanja %A Schroeder,Stefanie %A Wolstein,Joerg %A Herpertz,Stephan %A Steins-Loeber,Sabine %+ Department of Psychosomatic Medicine and Psychotherapy, LWL-University Hospital of the Ruhr-University Bochum, Alexandrinenstraße 1-3, Bochum, 44791, Germany, 49 0234 509 ext 59039, magdalena.pape@rub.de %K mobile health %K mHealth %K eHealth %K tailoring %K gender %K weight loss intervention %K mobile phone %D 2022 %7 27.10.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Given the increase in the prevalence of overweight and obesity worldwide, the number of digital weight loss interventions has also risen. However, these interventions often lack theoretical background and data on long-term effectiveness. The consideration of individual and gender differences in weight-related psychological parameters might enhance the efficacy and sustainability of mobile-based weight loss interventions. Objective: This paper presented an introduction to and the process evaluation of a 12-week gender-sensitive mobile health (mHealth) weight loss intervention (I-GENDO) combining computer-based and self-tailoring features. Methods: Between August 2020 and August 2021, individuals with overweight (BMI 25.0-29.9 kg/m²), those with obesity class I (BMI 30.0-34.9 kg/m²), and those with obesity class II (BMI 35.0-39.9 kg/m²) were recruited to the I-GENDO project, a multicenter study in Germany. The mHealth intervention aimed at targeting individual psychological factors associated with the development and persistence of overweight and obesity (eg, emotional eating) using computer-based tailoring. Moreover, the intervention took a gender-sensitive approach by implementing self-tailoring of gender-targeted module versions. The computer-based assignment of the main modules, self-selection of gender-targeted module versions, and use patterns were evaluated while considering gender. Moreover, gender differences in the usability assessment were analyzed. Results: Data from the intervention arm of the study were processed. A total of 116 individuals with overweight and obesity (77/116, 66.4% women; age mean 47.28, SD 11.66 years; BMI mean 33.58, SD 3.79 kg/m2) were included in the analyses. Overall, the compliance (90/109, 82.6%) and satisfaction with the app (mean 86% approval) were high and comparable with those of other mobile weight loss interventions. The usability of the intervention was rated with 71% (5.0/7.0 points) satisfaction. More women obtained the main module that focused on emotion regulation skills. Most men and women selected women-targeted versions of the main modules. Women used the app more frequently and longer than men. However, women and men did not differ in the progress of use patterns throughout the intervention. Conclusions: We developed a tailored gender-sensitive mHealth weight loss intervention. The usability of and engagement with the intervention were satisfactory, and the overall satisfaction with the intervention was also high. Gender differences must be considered in the evaluation of the effectiveness and sustainability of the intervention. %M 36301614 %R 10.2196/38480 %U https://formative.jmir.org/2022/10/e38480 %U https://doi.org/10.2196/38480 %U http://www.ncbi.nlm.nih.gov/pubmed/36301614 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 10 %P e38567 %T Quality Assessment of Hypertension Treatment–Related Information on WeChat: Cross-sectional Study %A Yang,Yuting %A Hou,Mengchi %A Gong,Xue %A Guo,Rui %A Feng,Xing Lin %A Tian,Rui %+ School of Public Health, Capital Medical University, No 10 Youanmenwai, Xitoutiao, Beijing, 100069, China, 86 01083911573, guorui@ccmu.edu.cn %K quality assessment %K hypertension %K WeChat %K DISCERN instrument %D 2022 %7 26.10.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The WeChat platform has become a primary source for medical information in China. However, no study has been conducted to explore the quality of information on WeChat for the treatment of hypertension, the leading chronic condition. Objective: This study aimed to explore the quality of information in articles on WeChat that are related to hypertension treatment from the aspects of credibility, concreteness, accuracy, and completeness. Methods: We searched for all information related to hypertension treatment on WeChat based on several inclusion and exclusion criteria. We used 2 tools to evaluate information quality, and 2 independent reviewers performed the assessment with the 2 tools separately. First, we adopted the DISCERN instrument to assess the credibility and concreteness of the treatment information, with the outcomes classified into five grades: excellent, good, fair, poor, and very poor. Second, we applied the Chinese Guidelines for Prevention and Treatment of Hypertension (2018 edition) to evaluate the accuracy and completeness of the article information with regard to specific medical content. Third, we combined the results from the 2 assessments to arrive at the overall quality of the articles and explored the differences between, and associations of, the 2 independent assessments. Results: Of the 223 articles that were retrieved, 130 (58.3%) full texts were included. Of these 130 articles, 81 (62.3%) described therapeutic measures for hypertension. The assessment based on the DISCERN instrument reported a mean score of 31.22 (SD 8.46). There were no articles rated excellent (mean score >63); most (111/130, 85.4%) of the articles did not refer to the consequences—in particular, quality of life—of no treatment. For specific medical content, adherence to the Chinese Guidelines for Prevention and Treatment of Hypertension was generally low in terms of accuracy and completeness, and there was much erroneous information. The overall mean quality score was 10.18 (SD 2.22) for the 130 articles, and the scores differed significantly across the 3 types (P=.03) and 5 sources (P=.02). Articles with references achieved higher scores for quality than those reporting none (P<.001). The results from the DISCERN assessment and the medical content scores were highly correlated (ρ=0.58; P<.001). Conclusions: The quality of hypertension treatment–related information on the WeChat platform is low. Future work is warranted to regulate information sources and strengthen references. For the treatment of hypertension, crucial information on the consequences of no treatment is urgently needed. %M 36287598 %R 10.2196/38567 %U https://www.jmir.org/2022/10/e38567 %U https://doi.org/10.2196/38567 %U http://www.ncbi.nlm.nih.gov/pubmed/36287598 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 10 %P e40292 %T A Smartphone App to Promote Patient Activation and Support Shared Decision-making in People With a Diagnosis of Schizophrenia in Outpatient Treatment Settings (Momentum Trial): Randomized Controlled Assessor-Blinded Trial %A Vitger,Tobias %A Hjorthøj,Carsten %A Austin,Stephen F %A Petersen,Lone %A Tønder,Esben Sandvik %A Nordentoft,Merete %A Korsbek,Lisa %+ Competence Center for Rehabilitation and Recovery, Mental Health Center Ballerup, Mental Health Services in the Capital Region of Denmark, Maglevænget 19, Ballerup, 2750, Denmark, 45 51408519, tobias246@hotmail.com %K mobile health %K mHealth %K digital intervention %K shared decision-making %K patient activation %K schizophrenia %K schizotypal %K early intervention %K randomized clinical trial %K mobile phone %D 2022 %7 26.10.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Shared decision-making (SDM) is a process aimed at facilitating patient-centered care by ensuring that the patient and provider are actively involved in treatment decisions. In mental health care, SDM has been advocated as a means for the patient to gain or regain control and responsibility over their life and recovery process. To support the process of patient-centered care and SDM, digital tools may have advantages in terms of accessibility, structure, and reminders. Objective: In this randomized controlled trial, we aimed to investigate the effect of a digital tool to support patient activation and SDM. Methods: The trial was designed as a randomized, assessor-blinded, 2-armed, parallel-group multicenter trial investigating the use of a digital SDM intervention for 6 months compared with treatment as usual. Participants with a diagnosis of schizophrenia, schizotypal or delusional disorder were recruited from 9 outpatient treatment sites in the Capital Region of Denmark. The primary outcome was the self-reported level of activation at the postintervention time point. The secondary outcomes included self-efficacy, hope, working alliance, satisfaction, preparedness for treatment consultation, symptom severity, and level of functioning. Explorative outcomes on the effect of the intervention at the midintervention time point along with objective data on the use of the digital tool were collected. Results: In total, 194 participants were included. The intention-to-treat analysis revealed a statistically significant effect favoring the intervention group on patient activation (mean difference 4.39, 95% CI 0.99-7.79; Cohen d=0.33; P=.01), confidence in communicating with one’s provider (mean difference 1.85, 95% CI 0.01-3.69; Cohen d=0.24; P=.05), and feeling prepared for decision-making (mean difference 5.12, 95% CI 0.16-10.08; Cohen d=0.27; P=.04). We found no effect of the digital SDM tool on treatment satisfaction, hope, self-efficacy, working alliance, severity of symptoms, level of functioning, use of antipsychotic medicine, and number or length of psychiatric hospital admissions. Conclusions: This trial showed a significant effect of a digital SDM tool on the subjective level of patient activation, confidence in communicating with one’s provider, and feeling prepared for decision-making at the postintervention time point. The effect size was smaller than the 0.42 effect size that we had anticipated and sampled for. The trial contributes to the evidence on how digital tools may support patient-centered care and SDM in mental health care. Trial Registration: ClinicalTrials.gov NCT03554655; https://clinicaltrials.gov/ct2/show/NCT03554655 International Registered Report Identifier (IRRID): RR2-10.1186/s12888-019-2143-2 %M 36287604 %R 10.2196/40292 %U https://www.jmir.org/2022/10/e40292 %U https://doi.org/10.2196/40292 %U http://www.ncbi.nlm.nih.gov/pubmed/36287604 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 10 %P e35962 %T Evaluation of a Web-Based Culturally Sensitive Educational Video to Facilitate Informed Cervical Cancer Screening Decisions Among Turkish- and Moroccan-Dutch Women Aged 30 to 60 Years: Randomized Intervention Study %A Hamdiui,Nora %A Stein,Mart L %A van Steenbergen,Jim %A Crutzen,Rik %A Bouman,Martine %A Khan,Abresham %A Çetin,Miyase N %A Timen,Aura %A van den Muijsenbergh,Maria %+ National Coordination Centre for Communicable Disease Control, Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Postbus 1, Bilthoven, 3720 BA, Netherlands, 31 088 689 7000, nora.hamdiui@rivm.nl %K cervical cancer %K screening %K informed decision-making %K web-based intervention %K culturally sensitive educational video %K Turkish %K Moroccan %K The Netherlands %D 2022 %7 26.10.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: In the Netherlands, since 1996, a national cervical cancer (CC) screening program has been implemented for women aged 30 to 60 years. Regional screening organizations send an invitation letter and information brochure in Dutch to the home addresses of targeted women every 5 years. Although this screening is free of charge, Turkish- and Moroccan-Dutch women, especially, show low screening participation and limited informed decision-making (IDM). As Turkish- and Moroccan-Dutch women indicated their need for information on the practical, emotional, cultural, and religious aspects of CC screening, we developed a culturally sensitive educational video (CSEV) as an addition to the current information brochure. Objective: In this study, we aimed to evaluate the added effect of the CSEV on IDM regarding CC screening participation among Turkish and Moroccan women aged 30 to 60 years in the Netherlands through a randomized intervention study. Methods: Initial respondents were recruited via several social media platforms and invited to complete a web-based questionnaire. Following respondent-driven sampling, respondents were asked to recruit a number of peers from their social networks to complete the same questionnaire. Respondents were randomly assigned to the control (current information brochure) or intervention condition (brochure and CSEV). We measured respondents’ knowledge and attitude regarding CC screening and their intention to participate in the next CC screening round before and after the control or intervention condition. We evaluated the added effect of the CSEV (above the brochure) on their knowledge, attitude, intention, and IDM using intention-to-treat analyses. Results: The final sample (n=1564) included 686 (43.86%) Turkish and 878 (56.14%) Moroccan-Dutch women. Of this sample, 50.7% (793/1564) were randomized to the control group (350/793, 44.1% Turkish and 443/793, 55.9% Moroccan) and 49.3% (771/1564) to the intervention group (336/771, 43.6% Turkish and 435/771, 56.4% Moroccan). Among the Turkish-Dutch women, 33.1% (116/350) of the control respondents and 40.5% (136/336) of the intervention respondents consulted the brochure (not statistically significant). Among Moroccan-Dutch women, these percentages were 28.2% (125/443) and 37.9% (165/435), respectively (P=.003). Of all intervention respondents, 96.1% (323/336; Turkish) and 84.4% (367/435; Moroccan) consulted the CSEV. The CSEV resulted in more positive screening attitudes among Moroccan-Dutch women than the brochure (323/435, 74.3% vs 303/443, 68.4%; P=.07). Women, who had never participated in CC screening before, showed significantly more often a positive attitude toward CC screening compared with the control group (P=.01). Conclusions: Our short and easily implementable CSEV resulted in more positive screening attitudes, especially in Moroccan-Dutch women. As the CSEV was also watched far more often than the current brochure was read, this intervention can contribute to better reach and more informed CC screening decisions among Turkish- and Moroccan-Dutch women. Trial Registration: International Clinical Trial Registry Platform NL8453; https://tinyurl.com/2dvbjxvc %M 36287585 %R 10.2196/35962 %U https://www.jmir.org/2022/10/e35962 %U https://doi.org/10.2196/35962 %U http://www.ncbi.nlm.nih.gov/pubmed/36287585 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 10 %P e35628 %T Long-term Effects of the Use of a Step Count–Specific Smartphone App on Physical Activity and Weight Loss: Randomized Controlled Clinical Trial %A Yoshimura,Eiichi %A Tajiri,Eri %A Michiwaki,Ryota %A Matsumoto,Naoyuki %A Hatamoto,Yoichi %A Tanaka,Shigeho %+ Department of Nutrition and Metabolism, National Institutes of Biomedical Innovation, Health and Nutrition, 1-23-1 Toyama, Shinjuku-ku, Tokyo, Tokyo, 162-8636, Japan, 81 0332035725, eyoshi@nibiohn.go.jp %K step counts %K weight loss %K smartphone app %K step count–specific mobile app %K physical activity %K moderate-to-vigorous intensity physical activity %K lifestyle intervention %K mHealth %K mobile app: mobile phone %D 2022 %7 24.10.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Some studies on weight loss promotion using smartphone apps have shown a weight loss effect but not an increase in physical activity. However, the long-term effects of smartphone apps on weight loss and increasing physical activity have not been rigorously examined to date. Objective: The aim of this study was to assess whether the use of a smartphone app will increase physical activity and reduce body weight. Methods: In this parallel randomized clinical trial, participants recruited between April 2018 and June 2019 were randomized in equal proportions to a smartphone app group (n=55) or a control group (n=54). The intention-to-treat approach was used to analyze the data from December 2019 through November 2021. Before the intervention, an hour-long lecture on weight loss instruction and increasing physical activity was conducted once for both groups. Participants in both groups were instructed to weigh themselves immediately after waking up at least once daily from the start of the intervention. Monthly emails were sent advising the participants in both groups on how to lose weight and increase physical activity in order to maintain or increase motivation. Participants in the smartphone app group were instructed to open the app at least once a day to check their step count and rank. The primary outcome was daily accelerometer-measured physical activity (step count) and the secondary outcome was body weight. Since there was a significant difference in the wear time of the accelerometer depending on the intervention period (P<.001), the number of steps and moderate-to-vigorous physical activity were also evaluated per wear time. Results: The mean age of the 109 participants in this study was 47 (SD 8) years. At baseline, the mean daily total steps were 7259 (SD 3256) steps per day for the smartphone app group and 8243 (SD 2815) steps per day for the control group. The difference in the step count per wear time between preintervention and postintervention was significantly different between the app group and the control group (average difference [95% CI], 65 [30 to 101] steps per hour vs –9 [–56 to 39] steps per hour; P=.042). The weight loss was –2.2 kg (SD –3.1%) in the smartphone app group and –2.2 kg (SD –3.1%) in the control group, with no significant difference between the groups. In addition, when divided into weekdays (Monday through Friday) and weekends (Saturday and Sunday), there was a significant interaction between step counts (P=.004) and MVPA (P=.003) during the intervention, with the app group showing higher interaction on weekends than the control group. Conclusions: In this trial, the group with the smartphone app intervention showed increased physical activity, especially on weekends. However, this increased physical activity did not lead to increased weight loss. Trial Registration: University Hospital Medical Information Network UMIN000033397; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037956 %M 36279159 %R 10.2196/35628 %U https://mhealth.jmir.org/2022/10/e35628 %U https://doi.org/10.2196/35628 %U http://www.ncbi.nlm.nih.gov/pubmed/36279159 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 10 %P e38183 %T Preventing Revictimization Through a Web-Based Intervention for Primary Caregivers of Youth in Care (EMPOWERYOU): Protocol for a Randomized Factorial Trial %A Heinrichs,Nina %A Brühl,Antonia %+ Department of Psychology, Clinical Psychology and Psychotherapy, University of Bremen, Grazer Str 6, Bremen, 28334, Germany, 49 42121868542, nina.heinrichs@uni-bremen.de %K multiphase optimization strategy %K foster children %K parenting %K revictimization %K web-based intervention %K online intervention %D 2022 %7 24.10.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Children in foster care are at a higher risk for relationship problems than their counterparts raised by their biological family because of higher exposure to or prevalence of neglect or maltreatment early in life. Consequently, these children may also show more challenging behavior in their foster families, which in turn increases the parental stress experience of foster caregivers. Furthermore, the children may engage in a vicious cycle of risky relationship behaviors and expectations that put them at a greater risk for revictimization. Objective: To support foster caregivers in reducing the risk for revictimization, several intervention modules delivered via the internet were developed using a consumer-based approach (phase 1 of the multiphase optimization strategy). This project (phase 2 of the multiphase optimization strategy) aimed to develop a sustainable intervention by selecting promising intervention components based on their contribution to the outcome. Methods: In a 24 factorial trial, a total of 317 foster caregivers with children aged 8 to 13 years are randomly assigned to 1 of 16 conditions. The primary outcome is the rate of revictimization from baseline to 3 months after intervention. Secondary outcomes include risk-taking and functional behaviors in relationships. All caregivers will receive access to all the intervention components after the follow-up assessment. The participants assigned to the condition with all component levels on are expected to show the best improvement in the primary and secondary outcomes. Results: Recruitment and data collection for the factorial trial started in March 2022 and is ongoing. As of October 2022, we recruited 181 families. Although it is difficult to predict the exact study timeline owing to COVID-19 pandemic–related delays, results are expected in February 2024. Conclusions: There is a need for easily accessible information related to raising children in foster care who have experienced early life adversities to interrupt the cycle of violence and enhance the developmental pathway of health and emotional stability. It might be useful, in addition to generally useful parenting information (eg, parental self-care or emotion regulation management), to specifically focus on the needs of these caregivers (eg, how to support the child to reduce dysfunctional relationship behaviors that may have developed because of early adverse experiences). Trial Registration: ClinicalTrials.gov NCT05235659; https://clinicaltrials.gov/ct2/show/NCT05235659 International Registered Report Identifier (IRRID): DERR1-10.2196/38183 %M 36279162 %R 10.2196/38183 %U https://www.researchprotocols.org/2022/10/e38183 %U https://doi.org/10.2196/38183 %U http://www.ncbi.nlm.nih.gov/pubmed/36279162 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 10 %P e37137 %T Internet-Delivered Self-help for Adults With ADHD (MyADHD): Usability Study %A Kenter,Robin Maria Francisca %A Schønning,Adrian %A Inal,Yavuz %+ Department of Clinical Psychology, Faculty of Psychology, University of Bergen, Christies gate 12, Bergen, 5015, Norway, 47 48464314, robken@helse-bergen.no %K usability testing %K user evaluation %K attention-deficit/hyperactivity disorder %K self-guided intervention %K internet-delivered %K self-help %K adults with attention-deficit/hyperactivity disorder %K intervention %K usability study %K care needs %K usability %D 2022 %7 21.10.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Although effective pharmacological treatment exists, many adults with attention-deficit/hyperactivity disorder (ADHD) prefer a nonpharmacological option for managing their symptoms. Internet-delivered self-help interventions have the potential to address this unmet supportive care need reported by adults with ADHD, at relatively low costs. However, if the intervention does not offer optimal functions, content, and layout, it could decrease adherence and engagement and potentially compromise the effectiveness of such interventions. Thus, there is a need for examining the usability and factors that enhance and impair the usability of internet-delivered self-help interventions. Objective: This study evaluates the usability of an internet-delivered self-help intervention for adults with ADHD (MyADHD). The main goals were to (1) collect qualitative and quantitative data on usability and (2) identify usability problems. Methods: Individual think-aloud interviews and staged usability testing (N=5) were conducted to evaluate the usability of the MyADHD intervention in terms of function, content, and design. MyADHD end users provided iterative feedback to maximize engagement and usability. They performed tasks involved in operating the intervention and provided “think-aloud” commentary and postsession usability ratings. The interviews were recorded, transcribed verbatim, and analyzed. Results: Participants were satisfied with the overall usability of the program. The average perceived usability score out of 100 was 70 for the first round of testing and improved to 77.5 after applying modifications, with a mean score of 75.5 (SD 5.9) for all rounds of usability testing. The analysis of the interviews revealed 3 central themes: functionality, content, and layout. Conclusions: Optimizing the usability of internet-delivered self-guided interventions is a critical step in the design and development process. The usability testing in this study provided valuable information from users’ perspectives on the content and platform of the intervention. Analysis revealed the need for intervention enhancement with regard to design, functionality, and content from the perspective of potential end users. Overall, participants saw value in the MyADHD intervention and were confident that they could use it for the self-management of symptoms and expressed the desire to use the entire intervention when it becomes available. Through this development process, we produced an intervention that is likely to be used successfully and is ready for deployment in a randomized controlled trial. Trial Registration: ClinicalTrials.gov NCT04511169; https://clinicaltrials.gov/ct2/show/NCT04511169 %M 36269662 %R 10.2196/37137 %U https://formative.jmir.org/2022/10/e37137 %U https://doi.org/10.2196/37137 %U http://www.ncbi.nlm.nih.gov/pubmed/36269662 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 10 %P e40488 %T The Efficacy of a Web-Based Stress Management Intervention for Employees Experiencing Adverse Working Conditions and Occupational Self-efficacy as a Mediator: Randomized Controlled Trial %A Nixon,Patricia %A Ebert,David Daniel %A Boß,Leif %A Angerer,Peter %A Dragano,Nico %A Lehr,Dirk %+ Department of Health Psychology and Applied Biological Psychology, Institute of Psychology, Leuphana University, Universitätsallee 1, Lueneburg, 21335, Germany, 49 41316772720, lehr@leuphana.de %K occupational eMental health %K stress %K occupational self-efficacy %K effort-reward imbalance %K randomized controlled trial %D 2022 %7 20.10.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Work stress is highly prevalent and puts employees at risk for adverse health consequences. Web-based stress management interventions (SMIs) promoting occupational self-efficacy might be a feasible approach to aid employees to alleviate this burden and to enable them to improve an unbalanced situation between efforts and rewards at work. Objective: The first aim of this randomized controlled trial was to investigate the efficacy of a web-based SMI for employees perceiving elevated stress levels and an effort-reward imbalance in comparison to a waitlist control (WLC) group. Second, we investigated whether the efficacy of an SMI could be explained by an increase in occupational self-efficacy and whether this personal resource enables employees to change adverse working conditions. Methods: A total of 262 employees reporting effort-reward imbalance scores over 0.715 and elevated stress levels (10-item Perceived Stress Scale [PSS-10] score ≥22) were randomly assigned to either the intervention group (IG; SMI) or the WLC group. The primary outcome was perceived stress measured using the PSS-10. The secondary outcomes included mental and work-related health measures. Four different mediation analyses were conducted with occupational self-efficacy, efforts, and rewards as mediators. After eligibility screening, data were collected web based at baseline (T1), 7 weeks (T2) and 6 months (T3). Results: Study participation was completed by 80% (105/130, 80.8%) in the IG and 90% (119/132, 90.2%) in the WLC group. Analyses of covariance revealed that stress reduction was significantly higher for the SMI group compared with the WLC group at T2 (d=0.87, 95% CI 0.61-1.12, P<.001) and T3 (d=0.65, 95% CI 0.41-0.90, P<.001). Mediation analyses indicated that occupational self-efficacy mediated the beneficial effect of the SMI on stress directly. Furthermore, the analyses revealed a significant indirect effect of occupational self-efficacy via rewards (b=0.18, t259=4.52, P<.001), but not via efforts (b=0.01, t259=0.27, P>.05) while efforts still had a negative impact on stress (b=0.46, t257=2.32, P<.05). Conclusions: The SMI was effective in reducing stress and improving occupational self-efficacy in employees despite them experiencing an effort-reward imbalance at work. Results from mediation analyses suggest that fostering personal resources such as occupational self-efficacy contributes to the efficacy of the SMI and enables employees to achieve positive changes regarding the rewarding aspects of the workplace. However, the SMI seemed to neither directly nor indirectly impact efforts, suggesting that person-focused interventions might not be sufficient and need to be complemented by organizational-focused interventions to comprehensively improve mental health in employees facing adverse working conditions. Trial Registration: German Clinical Trials Register DRKS00005990; https://tinyurl.com/23fmzfu3 %M 36264607 %R 10.2196/40488 %U https://www.jmir.org/2022/10/e40488 %U https://doi.org/10.2196/40488 %U http://www.ncbi.nlm.nih.gov/pubmed/36264607 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 10 %P e38501 %T The Impact of a Theory-Based mHealth Intervention on Disease Knowledge, Self-efficacy, and Exercise Adherence Among Ankylosing Spondylitis Patients: Randomized Controlled Trial %A Song,Yuqing %A Reifsnider,Elizabeth %A Chen,Yanling %A Wang,Ying %A Chen,Hong %+ West China School of Nursing, West China Hospital, Sichuan University, No 37 Guoxue Xiang, Wuhou District, Chengdu, 610041, China, 86 189 8060 1733, 1366109878@qq.com %K rheumatic disease %K health belief model %K mobile health %K patient education %K WeChat %D 2022 %7 20.10.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Patient education is recommended as an integral part of disease management in ankylosing spondylitis (AS), a chronic rheumatic disease that predominantly affects young males and requires long-term disease management. Convenient and cost-effective approaches to deliver patient education are required to these patients. Objective: This study aimed to examine the effects of a theory-based educational intervention delivered through a social networking app, WeChat, on disease knowledge, self-efficacy, exercise adherence, and health outcomes in Chinese AS patients. Methods: This study was a single-blind randomized controlled trial conducted in a tertiary hospital in Chengdu, China. Eligible participants were randomly allocated to the intervention or control group. Participants in the control group received standard care. The intervention group received the health belief model (HBM)-based educational intervention, consisting of 4 individual educational sessions and educational information sharing through WeChat, the predominant social networking app in China. The primary outcomes were disease knowledge, self-efficacy, and exercise adherence. The secondary outcomes were disease activity and physical function. Data were collected at baseline and at the end of the intervention (12th week). Chi-square test, t test, Mann-Whitney U tests were used to examine the effects of educational intervention. Results: This study included 118 patients with AS. The majority of participants were male (93/118, 78.8%). Around half of them were married (56/118, 47.5%), never smoked (70/118, 59.3%), and had college educational level or above (62/118, 52.5%). At posttest, participants in the intervention group had higher disease knowledge (all P<.001) and self-efficacy (P<.001), and a larger proportion of participants in the intervention group adhered to regular exercise routines than those in the control group (P=.003). The within-group analyses for the intervention group showed increases in all scores of disease knowledge (all P<.001) and self-efficacy score (P<.001), but only correct answer score (P=.04) and general knowledge score (P=.002) of disease knowledge in the control group improved. The within-group analysis for the control group found a decline of physical function (P=.002) but no significant change in disease activity (P>.05). The within-group analysis for the intervention group showed no significant change in disease activity or physical function (P>.05). At posttest, no statistically significant difference was found on disease activity or physical function between the intervention and control groups (P>.05). Conclusions: The HBM-based educational intervention through WeChat can effectively improve patient disease knowledge, self-efficacy, and exercise adherence. WeChat is feasible and effective to deliver patient education for patients with chronic diseases such as AS. This mHealth intervention can be integrated into routine rheumatology care. Trial Registration: Chinese Clinical Trial Registry ChiCTR-IPR-16009293; https://tinyurl.com/swxt8xk7 %M 36264605 %R 10.2196/38501 %U https://www.jmir.org/2022/10/e38501 %U https://doi.org/10.2196/38501 %U http://www.ncbi.nlm.nih.gov/pubmed/36264605 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 8 %N 4 %P e32153 %T A Web-Based Prostate Cancer–Specific Holistic Needs Assessment (CHAT-P): Multimethod Study From Concept to Clinical Practice %A Nanton,Veronica %A Appleton,Rebecca %A Ahmed,Nisar %A Loew,Joelle %A Roscoe,Julia %A Muthuswamy,Radha %A Patel,Prashant %A Dale,Jeremy %A Ahmedzai,Sam H %+ Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry, United Kingdom, 44 2476 574025, v.nanton@warwick.ac.uk %K Holistic Needs Assessment %K prostate cancer %K survivorship %K cancer follow-up %K coproduction %K web-based communication %K care planning %D 2022 %7 19.10.2022 %9 Original Paper %J JMIR Cancer %G English %X Background: Men with prostate cancer experience immediate and long-term consequences of the disease and its treatment. They require both long-term monitoring for recurrence or progression and follow-up to identify and help manage psychosocial and physical impacts. Holistic Needs Assessment aims to ensure patient-centered continuing cancer care. However, paper-based generic tools have had limited uptake within cancer services, and there is little evidence of their impact. With the expansion of remote methods of care delivery and to enhance the value of generic tools, we developed a web-based Composite Holistic Needs Assessment Adaptive Tool-Prostate (CHAT-P) specifically for prostate cancer. Objective: This paper described the context, conceptual underpinning, and approach to design that informed the development of CHAT-P, starting from the initial concept to readiness for deployment. Through this narrative, we sought to contribute to the expanding body of knowledge regarding the coproduction process of innovative digital systems with potential for enhanced cancer care delivery. Methods: The development of CHAT-P was guided by the principles of coproduction. Men with prostate cancer and health care professionals contributed to each stage of the process. Testing was conducted iteratively over a 5-year period. An initial rapid review of patient-reported outcome measures identified candidate items for inclusion. These items were categorized and allocated to overarching domains. After the first round of user testing, further items were added, improvements were made to the adaptive branching system, and response categories were refined. A functioning version of CHAT-P was tested with 16 patients recruited from 3 outpatient clinics, with interviewers adopting the think-aloud technique. Interview transcripts were analyzed using a framework approach. Interviews and informal discussions with health care professionals informed the development of a linked care plan and clinician-facing platform, which were incorporated into a separate feasibility study of digitally enhanced integrated cancer care. Results: The findings from the interview study demonstrated the usability, acceptability, and potential value of CHAT-P. Men recognized the benefits of a personalized approach and the importance of a holistic understanding of their needs. Preparation for the consultation by the completion of CHAT-P was also recognized as empowering. The possible limitations identified were related to the importance of care teams responding to the issues selected in the assessment. The subsequent feasibility study highlighted the need for attention to men’s psychological concerns and demonstrated the ability of CHAT-P to capture red flag symptoms requiring urgent investigation. Conclusions: CHAT-P offers an innovative means by which men can communicate their concerns to their health care teams before a physical or remote consultation. There is now a need for a full evaluation of the implementation process and outcomes where CHAT-P is introduced into the clinical pathway. There is also scope for adapting the CHAT-P model to other cancers. %M 36260380 %R 10.2196/32153 %U https://cancer.jmir.org/2022/4/e32153 %U https://doi.org/10.2196/32153 %U http://www.ncbi.nlm.nih.gov/pubmed/36260380 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 10 %P e34089 %T Developing the "Choosing Health" Digital Weight Loss and Maintenance Intervention: Intervention Mapping Study %A Palacz-Poborczyk,Iga %A Idziak,Paulina %A Januszewicz,Anna %A Luszczynska,Aleksandra %A Quested,Eleanor %A Naughton,Felix %A Hagger,Martin S %A Pagoto,Sherry %A Verboon,Peter %A Robinson,Suzanne %A Kwasnicka,Dominika %+ Faculty of Psychology, SWPS University of Social Sciences and Humanities, Aleksandra Ostrowskiego 30b, Wroclaw, 53-238, Poland, 48 501205532, dkwasnicka@gmail.com %K behavior change %K behavior maintenance %K behavioral theory %K weight loss %K overweight %K obesity %K randomized controlled trial %K digital health %K within-person design %K Intervention Mapping %D 2022 %7 18.10.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital health promotion programs tailored to the individual are a potential cost-effective and scalable solution to enable self-management and provide support to people with excess body weight. However, solutions that are widely accessible, personalized, and theory- and evidence-based are still limited. Objective: This study aimed to develop a digital behavior change program, Choosing Health, that could identify modifiable predictors of weight loss and maintenance for each individual and use these to provide tailored support. Methods: We applied an Intervention Mapping protocol to design the program. This systematic approach to develop theory- and evidence-based health promotion programs consisted of 6 steps: development of a logic model of the problem, a model of change, intervention design and intervention production, the implementation plan, and the evaluation plan. The decisions made during the Intervention Mapping process were guided by theory, existing evidence, and our own research—including 4 focus groups (n=40), expert consultations (n=12), and interviews (n=11). The stakeholders included researchers, public representatives (including individuals with overweight and obesity), and experts from a variety of relevant backgrounds (including nutrition, physical activity, and the health care sector). Results: Following a structured process, we developed a tailored intervention that has the potential to reduce excess body weight and support behavior changes in people with overweight and obesity. The Choosing Health intervention consists of tailored, personalized text messages and email support that correspond with theoretical domains potentially predictive of weight outcomes for each participant. The intervention content includes behavior change techniques to support motivation maintenance, self-regulation, habit formation, environmental restructuring, social support, and addressing physical and psychological resources. Conclusions: The use of an Intervention Mapping protocol enabled the systematic development of the Choosing Health intervention and guided the implementation and evaluation of the program. Through the involvement of different stakeholders, including representatives of the general public, we were able to map out program facilitators and barriers while increasing the ecological validity of the program to ensure that we build an intervention that is useful, user-friendly, and informative. We also summarized the lessons learned for the Choosing Health intervention development and for other health promotion programs. International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2020-040183 %M 36256827 %R 10.2196/34089 %U https://www.jmir.org/2022/10/e34089 %U https://doi.org/10.2196/34089 %U http://www.ncbi.nlm.nih.gov/pubmed/36256827 %0 Journal Article %@ 2152-7202 %I JMIR Publications %V 14 %N 1 %P e35318 %T Text Messages to Support Caregivers in a Health Care System: Development and Pilot and National Rollout Evaluation %A Martindale-Adams,Jennifer Lynn %A Clark,Carolyn Davis %A Martin,Jessica Roxy %A Henderson,Charles Richard %A Nichols,Linda Olivia %+ Veterans Affairs Caregiver Center - Caregiver Support Program, Memphis VA Medical Center, Department of Veterans Affairs, 1030 Jefferson, Memphis, TN, 38104, United States, 1 901 523 8990 ext 5082, linda.nichols@va.gov %K mobile health %K mHealth %K self-care %K veterans %K family caregivers %K emotional stress %K burden of illness %K self-efficacy %K mobile phone %D 2022 %7 17.10.2022 %9 Original Paper %J J Particip Med %G English %X Background: Although there are many interventions to support caregivers, SMS text messaging has not been used widely. Objective: In this paper, we aimed to describe development of the Department of Veterans Affairs (VA) Annie Stress Management SMS text messaging protocol for caregivers of veterans, its pilot test, and subsequent national rollout. Methods: The stress management protocol was developed with text messages focusing on education, motivation, and stress-alleviating activities based on the Resources for Enhancing All Caregivers Health (REACH) VA caregiver intervention. This protocol was then tested in a pilot study. On the basis of the pilot study results, a national rollout of the protocol was executed and evaluated. Caregivers were referred from VA facilities nationally for the pilot and national rollout. Pilot caregivers were interviewed by telephone; national rollout caregivers were sent a web-based evaluation link at 6 months. For both evaluations, questions were scored on a Likert scale ranging from completely disagree to completely agree. For both the pilot and national rollout, quantitative data were analyzed with frequencies and means; themes were identified from open-ended qualitative responses. Results: Of the 22 caregivers in the pilot study, 18 (82%) provided follow-up data. On a 5-point scale, they reported text messages had been useful in managing stress (mean score 3.8, SD 1.1), helping them take care of themselves (mean score 3.7, SD 1.3), and making them feel cared for (mean score 4.1, SD 1.7). Texts were easy to read (mean score 4.5, SD 1.2), did not come at awkward times (mean score 2.2, SD 1.4), were not confusing (mean score 1.1, SD 0.2), and did not cause problems in responding (mean score 1.9, 1.1); however, 83% (15/18) of caregivers did not want to request an activity when stressed. Consequently, the national protocol did not require caregivers to respond. In the national rollout, 22.17% (781/3522) of the eligible caregivers answered the web-based survey and reported that the messages had been useful in managing stress (mean score 4.3, SD 0.8), helping them take care of themselves (mean score 4.3, SD 0.8) and loved ones (mean score 4.2, SD 0.8), and making them feel cared for (mean score 4.5, SD 0.8). Almost two-thirds (509/778, 65.4%) of the participants tried all or most of the strategies. A total of 5 themes were identified. The messages were appreciated, helped with self-care, and made them feel less alone, looking on Annie as a friend. The caregivers reported that the messages were on target and came when they were most needed and did not want them to stop. This success has led to four additional caregiver texting protocols: bereavement, dementia behaviors and stress management, (posttraumatic stress disorder) PTSD behaviors, and taking care of you, with 7274 caregivers enrolled as of February 2022. Conclusions: Caregivers reported the messages made them feel cared for and more confident. SMS text messaging, which is incorporated into clinical settings and health care systems, may represent a low-cost way to provide useful and meaningful support to caregivers. %M 36251368 %R 10.2196/35318 %U https://jopm.jmir.org/2022/1/e35318 %U https://doi.org/10.2196/35318 %U http://www.ncbi.nlm.nih.gov/pubmed/36251368 %0 Journal Article %@ 2369-3762 %I JMIR Publications %V 8 %N 4 %P e40520 %T The Educational Impact of Web-Based, Faculty-Led Continuing Medical Education Programs in Type 2 Diabetes: A Survey Study to Analyze Changes in Knowledge, Competence, and Performance of Health Care Professionals %A Harris,Stewart B %A Idzik,Shannon %A Boasso,Adriano %A Neunie,Sola Quasheba %A Noble,Alexander Daniel %A Such,Helen Elaine %A Van,Joanna %+ University Clinical Investigators (d.b.a. Diabetes Research Center), 2492 Walnut Avenue, Suite 130, Tustin, CA, 92780, United States, 1 410 706 8129, jvan@uciinc.net %K clinical case %K competence %K continuing medical education %K knowledge %K multidisciplinary team %K web-based education %K performance %K type 2 diabetes %D 2022 %7 14.10.2022 %9 Original Paper %J JMIR Med Educ %G English %X Background: The treatment landscape for type 2 diabetes (T2D) is continually evolving; therefore, ongoing education of health care professionals (HCPs) is essential. There is growing interest in measuring the impact of educational activities, such as through use of the Moore framework; however, data on the benefits of continuing medical education (CME) in the management of T2D remain limited. Objective: This study aimed to evaluate HCP satisfaction; measure improvements in knowledge, competence, and performance following short, case-based, multidisciplinary web-based CME activities; and identify the remaining educational gaps. Methods: Two faculty-led, CME-accredited, web-based educational activities on T2D and obesity, touchIN CONVERSATION and touch MultiDisciplinary Team, were developed and made available on a free-to-access medical education website. Each activity comprised 3 videos lasting 10 to 15 minutes, which addressed learning objectives developed based on a review of published literature and faculty feedback. Participant satisfaction (Moore level 2) was evaluated using a postactivity questionnaire. For both activities, changes in knowledge and competence (Moore levels 3 and 4) were assessed using questionnaires completed by representative HCPs before or after participation in the activities. A second set of HCPs completed a questionnaire before and after engaging in activities that assessed changes in self-reported performance (Moore level 5). Results: Each activity was viewed by approximately 6000 participants within 6 months. The participants expressed high levels of satisfaction (>80%) with both activities. Statistically significant improvements from baseline in knowledge and competence were reported following participation in touchIN CONVERSATION (mean score, SD before vs after activity: 4.36, 1.40 vs 5.42, 1.37; P<.001), with the proportion of learners answering at least six of 7 questions correctly, increasing from 22% (11/50) to 60% (30/50). A nonsignificant improvement in knowledge and competence was observed following participation in touch MultiDisciplinary Team (mean score, SD 4.36, 1.24 vs 4.58, 1.07; P=.35); however, baseline knowledge and competence were relatively high, where 80% of the respondents (40/50) answered at least four of 6 questions correctly. A significant improvement in HCP self-reported performance was observed in a combined analysis of both activities (mean score, SD 2.65, 1.32 vs 3.15, 1.26; P=.03), with the proportion of learners selecting the answer representing the best clinical option for all 4 questions increasing from 32% (11/34) to 59% (20/34) after the activity. Several unmet educational needs were self-reported or identified from the analysis of incorrectly answered questions, including setting individualized glycemic targets and the potential benefits of sodium-glucose cotransporter 2 inhibitor therapies. Conclusions: Short, case-based, web-based CME activities designed for HCPs to fit their clinical schedules achieved improvements in knowledge, competence, and self-reported performance in T2D management. Ongoing educational needs identified included setting individualized glycemic targets and the potential benefits of sodium-glucose cotransporter 2 inhibitor therapies. %M 36102282 %R 10.2196/40520 %U https://mededu.jmir.org/2022/4/e40520 %U https://doi.org/10.2196/40520 %U http://www.ncbi.nlm.nih.gov/pubmed/36102282 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 10 %P e41410 %T Digital Peer-Supported Self-Management Intervention Codesigned by People With Long COVID: Mixed Methods Proof-of-Concept Study %A Wright,Hayley %A Turner,Andrew %A Ennis,Stuart %A Percy,Carol %A Loftus,Garry %A Clyne,Wendy %A Matouskova,Gabriela %A Martin,Faith %+ Centre for Intelligent Healthcare, Coventry University, Richard Crossman Building, Jordan Well, Coventry, CV1 5RW, United Kingdom, 44 02477659509, ab7764@coventry.ac.uk %K long COVID %K self-management %K peer support %K digital intervention %K goal setting %K psychological %K physical %K cognitive %K intervention %K United Kingdom %K UK %K efficacy %K COVID-19 %D 2022 %7 14.10.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: There are around 1.3 million people in the United Kingdom with the devastating psychological, physical, and cognitive consequences of long COVID (LC). UK guidelines recommend that LC symptoms be managed pragmatically with holistic support for patients’ biopsychosocial needs, including psychological, emotional, and physical health. Self-management strategies, such as pacing, prioritization, and goal setting, are vital for the self-management of many LC symptoms. Objective: This paper describes the codevelopment and initial testing of a digital intervention combining peer support with positive psychology approaches for self-managing the physical, emotional, psychological, and cognitive challenges associated with LC. The objectives of this study were to (1) codesign an intervention with and for people with LC; (2) test the intervention and study methods; (3) measure changes in participant well-being, self-efficacy, fatigue, and loneliness; and (4) understand the types of self-management goals and strategies used by people with LC. Methods: The study used a pre-post, mixed methods, pragmatic, uncontrolled design. Digital intervention content was codeveloped with a lived-experience group to meet the needs uncovered during the intervention development and logic mapping phase. The resulting 8-week digital intervention, Hope Programme for Long COVID, was attended by 47 participants, who completed pre- and postprogram measures of well-being, self-efficacy, fatigue, and loneliness. Goal-setting data were extracted from the digital platform at the end of the intervention. Results: The recruitment rate (n=47, 83.9%) and follow-up rate (n=28, 59.6%) were encouraging. Positive mental well-being (mean difference 6.5, P<.001) and self-efficacy (mean difference 1.1, P=.009) improved from baseline to postcourse. All goals set by participants mapped onto the 5 goal-oriented domains in the taxonomy of everyday self-management strategies (TEDSS). The most frequent type of goals was related to activity strategies, followed by health behavior and internal strategies. Conclusions: The bespoke self-management intervention, Hope Programme for Long COVID, was well attended, and follow-up was encouraging. The sample characteristics largely mirrored those of the wider UK population with LC. Although not powered to detect statistically significant changes, the preliminary data show improvements in self-efficacy and positive mental well-being. Our next trial (ISRCTN: 11868601) will use a nonrandomized waitlist control design to further examine intervention efficacy. %M 36166651 %R 10.2196/41410 %U https://formative.jmir.org/2022/10/e41410 %U https://doi.org/10.2196/41410 %U http://www.ncbi.nlm.nih.gov/pubmed/36166651 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 10 %P e39869 %T mHealth Technologies for Managing Problematic Pornography Use: Content Analysis %A Henry,Nathan %A Donkin,Liesje %A Williams,Matt %A Pedersen,Mangor %+ Auckland University of Technology, 55 Wellesley Street East, Auckland CBD, Auckland, 1010, New Zealand, 64 9 921 9666 ext 7304, nathan.henry@aut.ac.nz %K pornography %K compulsive sexual behavior disorder %K CSBD %K mobile health %K mHealth %K problematic pornography use %K PPU %K mobile intervention %K just-in-time adaptive intervention %K smartphone-based therapy %K addiction %K internet addiction %K behavioral addiction %K mobile phone %D 2022 %7 13.10.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Several mobile apps are currently available that purportedly help with managing pornography addiction. However, the utility of these apps is unclear, given the lack of literature on the effectiveness of mobile health solutions for problematic pornography use. Little is also known about the content, structure, and features of these apps. Objective: This study aims to characterize the purpose, content, and popularity of mobile apps that claim to manage pornography addiction. Methods: The phrase “pornography addiction” was entered as a search term in the app stores of the two major mobile phone platforms (Android and iOS). App features were categorized according to a coding scheme that contained 16 categories. Apps were included in the analysis if they were described as helpful for reducing pornography use, and data were extracted from the store descriptions of the apps. Metrics such as number of user ratings, mean rating score, and number of installations were analyzed on a per-feature basis. Results: In total, 170 apps from both app stores met the inclusion criteria. The five most common and popular features, both in terms of number of apps with each feature and minimum possible number of installations, were the ability to track the time since last relapse (apps with feature=72/170, 42.4%; minimum possible number of installations=6,388,000), tutorials and coaching (apps with feature=63/170, 37.1%; minimum possible number of installations=9,286,505), access to accountability partners or communities (apps with feature=51/170, 30%; minimum possible number of installations=5,544,500), content blocking or content monitoring (apps with feature=46/170, 27.1%; minimum possible number of installations=17,883,000), and a reward system for progress (apps with feature=34/170, 20%; minimum possible number of installations=4,425,300). Of these features, content-blocking apps had the highest minimum possible number of installations. Content blocking was also the most detected feature combination in a combinatorial analysis (with 28 apps having only this feature), but it also had the lowest mean consumer satisfaction rating (4.04) and second-lowest median rating (4.00) out of 5 stars. None of the apps reviewed contained references to literature that provided direct evidence for the app’s efficacy or safety. Conclusions: There are several apps with the potential to provide low- or zero-cost real-time interventions for people struggling to manage problematic pornography use. Popular app features include blockers of pornographic content, behavior monitoring, and tutorials that instruct users how to eliminate pornography use. However, there is currently no empirical evidence to support the effectiveness and safety of these apps. Further research is required to be able to provide recommendations about which apps (and app features) are safe for public consumption. %M 36227634 %R 10.2196/39869 %U https://formative.jmir.org/2022/10/e39869 %U https://doi.org/10.2196/39869 %U http://www.ncbi.nlm.nih.gov/pubmed/36227634 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 10 %P e35923 %T Factors Related to Smoking and Perceptions of a Behavioral Counseling and Messenger Service–Delivered Smoking Cessation Intervention for People With HIV in China: Qualitative Study %A Yang,Shanyin %A Huang,Jiegang %A Ye,Li %A Lin,Jianyan %A Xie,Zhiman %A Guo,Baodong %A Li,Yanjun %A Liang,Bingyu %A Zheng,Zhigang %A Lunze,Karsten %A Abdullah,Abu S %A Liang,Hao %A Quintiliani,Lisa M %+ Department of Medicine, Boston Univeristy School of Medicine, 72 E Concord St, Boston, MA, 02118, United States, 1 617 638 2777, lisa.quintiliani@bmc.org %K mobile health %K mHealth %K China %K smoking %K smoking cessation %K HIV %K qualitative research %K SMS text messages %K WeChat %D 2022 %7 12.10.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: China, where half of the adult male population smoke tobacco, has one of the highest global burdens of smoking. Smoking rates are even higher among people with HIV. People with HIV can be affected by smoking in multiple ways, including more severe HIV-related symptoms and worse antiretroviral therapy treatment outcomes. However, smoking cessation services targeted for people with HIV are not routinely integrated into HIV care in China. Given the widespread mobile phone ownership, an exploration of factors related to smoking among people with HIV in China who smoke could inform the design and implementation of mobile smoking cessation interventions that target the needs of this vulnerable population. Objective: This study aims to explore the perspectives of smoking, barriers and facilitators to quitting, and perceptions related to a smoking cessation intervention delivered through behavioral counseling sessions and brief daily messenger service (WeChat)–delivered messages. Methods: We recruited people with HIV from the People’s 4th Hospital of Nanning, Guangxi, China, and conducted semistructured face-to-face interviews. All interviews were audio-recorded, transcribed verbatim in Chinese, and translated into English for data analysis. We conducted a thematic analysis using a codebook, which was guided by a team-based consensus approach to identify 5 main themes. We also explored themes according to the demographic groups. Results: A total of 24 participants were enrolled in the study. The mean age was 37.2 (SD=13.5) years. The participants had lived with HIV for a mean of 2.4 years. The majority were male (18/24, 75%) and lived in urban or metropolitan settings (19/24, 79%). We identified five main themes: variable knowledge of the harms of smoking, both related and unrelated to HIV; willpower perceived as the primary quitting strategy; a duality of the effect of social factors on quitting; perceptions about optimal features of the smoking cessation intervention (eg, messages should be brief and most frequent during the first few weeks); and the largely negative impact of their HIV diagnosis on smoking behaviors. In addition, some themes differed according to participant demographic characteristics such as age, sex, and education level. Conclusions: We identified barriers to and facilitators of smoking cessation among people with HIV in China by conducting semistructured qualitative interviews. Owing to the adverse impact of smoking on HIV outcomes, targeting cessation interventions to the unique needs and preferences of people with HIV in China may be needed to increase the effectiveness of future interventions. A pilot clinical trial will be conducted in the future to evaluate this behavioral counseling and brief daily messenger service (WeChat)–delivered messages approach among people with HIV who smoke in China. %M 36222795 %R 10.2196/35923 %U https://formative.jmir.org/2022/10/e35923 %U https://doi.org/10.2196/35923 %U http://www.ncbi.nlm.nih.gov/pubmed/36222795 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 10 %P e38710 %T Influence of Digital Intervention Messaging on Influenza Vaccination Rates Among Adults With Cardiovascular Disease in the United States: Decentralized Randomized Controlled Trial %A Marshall,Nell J %A Lee,Jennifer L %A Schroeder,Jessica %A Lee,Wei-Nchih %A See,Jermyn %A Madjid,Mohammad %A Munagala,Mrudula R %A Piette,John D %A Tan,Litjen %A Vardeny,Orly %A Greenberg,Michael %A Liska,Jan %A Mercer,Monica %A Samson,Sandrine %+ Evidation Health, Inc, 63 Bovet Rd #146, San Mateo, CA, 94402, United States, 1 (415) 515 1985, nmarshall@evidation.com %K influenza %K randomized trial %K public health %K cardiovascular disease %K immunization %K vaccination %K digital messaging %K digital intervention %K mobile health %K mHealth %D 2022 %7 7.10.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Seasonal influenza affects 5% to 15% of Americans annually, resulting in preventable deaths and substantial economic impact. Influenza infection is particularly dangerous for people with cardiovascular disease, who therefore represent a priority group for vaccination campaigns. Objective: We aimed to assess the effects of digital intervention messaging on self-reported rates of seasonal influenza vaccination. Methods: This was a randomized, controlled, single-blind, and decentralized trial conducted at individual locations throughout the United States over the 2020-2021 influenza season. Adults with self-reported cardiovascular disease who were members of the Achievement mobile platform were randomized to receive or not receive a series of 6 patient-centered digital intervention messages promoting influenza vaccination. The primary end point was the between-group difference in self-reported vaccination rates at 6 months after randomization. Secondary outcomes included the levels of engagement with the messages and the relationship between vaccination rates and engagement with the messages. Subgroup analyses examined variation in intervention effects by race. Controlling for randomization group, we examined the impact of other predictors of vaccination status, including cardiovascular condition type, vaccine drivers or barriers, and vaccine knowledge. Results: Of the 49,138 randomized participants, responses on the primary end point were available for 11,237 (22.87%; 5575 in the intervention group and 5662 in the control group) participants. The vaccination rate was significantly higher in the intervention group (3418/5575, 61.31%) than the control group (3355/5662, 59.25%; relative risk 1.03, 95% CI 1.004-1.066; P=.03). Participants who were older, more educated, and White or Asian were more likely to report being vaccinated. The intervention was effective among White participants (P=.004) but not among people of color (P=.42). The vaccination rate was 13 percentage points higher among participants who completed all 6 intervention messages versus none, and at least 2 completed messages appeared to be needed for effectiveness. Participants who reported a diagnosis of COVID-19 were more likely to be vaccinated for influenza regardless of treatment assignment. Conclusions: This personalized, evidence-based digital intervention was effective in increasing vaccination rates in this population of high-risk people with cardiovascular disease. Trial Registration: ClinicalTrials.gov NCT04584645; https://clinicaltrials.gov/ct2/show/NCT04584645 %M 36206046 %R 10.2196/38710 %U https://www.jmir.org/2022/10/e38710 %U https://doi.org/10.2196/38710 %U http://www.ncbi.nlm.nih.gov/pubmed/36206046 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 10 %P e37968 %T A Digital Mental Health Intervention (Inuka) for Common Mental Health Disorders in Zimbabwean Adults in Response to the COVID-19 Pandemic: Feasibility and Acceptability Pilot Study %A Dambi,Jermaine %A Norman,Clara %A Doukani,Asmae %A Potgieter,Stephan %A Turner,Jean %A Musesengwa,Rosemary %A Verhey,Ruth %A Chibanda,Dixon %+ Rehabilitation Sciences Unit, Faculty of Medicine and Health Sciences, University of Zimbabwe, Mt Pleasant, Harare, Zimbabwe, 263 773444911, jermainedambi@gmail.com %K acceptability %K COVID-19 %K feasibility %K Friendship Bench %K Inuka %K pilot %K task-shifting %K Zimbabwe %D 2022 %7 7.10.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Common mental health disorders (CMDs) are leading causes of disability globally. The ongoing COVID-19 pandemic has further exacerbated the burden of CMDs. COVID-19 containment measures, including lockdowns, have disrupted access to in-person mental health care. It is therefore imperative to explore the utility of digital mental health interventions to bridge the treatment gap. Mobile health technologies are effective tools for increasing access to treatment at a lower cost. This study explores the utility of Inuka, a chat-based app hinged on the Friendship Bench problem-solving therapy intervention. The Inuka app offers double anonymity, and clients can book or cancel a session at their convenience. Inuka services can be accessed either through a mobile app or the web. Objective: We aimed to explore the feasibility of conducting a future clinical trial. Additionally, we evaluated the feasibility, acceptability, appropriateness, scalability, and preliminary effectiveness of Inuka. Methods: Data were collected using concurrent mixed methods. We used a pragmatic quasiexperimental design to compare the feasibility, acceptability, and preliminary clinical effectiveness of Inuka (experimental group) and WhatsApp chat-based counseling (control). Participants received 6 problem-solving therapy sessions delivered by lay counselors. A reduction in CMDs was the primary clinical outcome. The secondary outcomes were health-related quality of life (HRQoL), disability and functioning, and social support. Quantitative outcomes were analyzed using descriptive and bivariate statistics. Finally, we used administrative data and semistructured interviews to gather data on acceptability and feasibility; this was analyzed using thematic analysis. Results: Altogether, 258 participants were screened over 6 months, with 202 assessed for eligibility, and 176 participants were included in the study (recruitment ratio of 29 participants/month). The participants’ mean age was 24.4 (SD 5.3) years, and most participants were female and had tertiary education. The mean daily smartphone usage was 8 (SD 3.5) hours. Eighty-three users signed up and completed at least one session. The average completion rate was 3 out of 4 sessions. Inuka was deemed feasible and acceptable in the local context, with connectivity challenges, app instability, expensive mobile data, and power outages cited as potential barriers to scale up. Generally, there was a decline in CMDs (F2,73=2.63; P=.08), depression (F2,73=7.67; P<.001), and anxiety (F2,73=2.95; P=.06) and a corresponding increase in HRQoL (F2,73=7.287; P<.001) in both groups. Conclusions: Study outcomes showed that it is feasible to run a future large-scale randomized clinical trial (RCT) and lend support to the feasibility and acceptability of Inuka, including evidence of preliminary effectiveness. The app’s double anonymity and structured support were the most salient features. There is a great need for iterative app updates before scaling up. Finally, a large-scale hybrid RCT with a longer follow-up to evaluate the clinical implementation and cost-effectiveness of the app is needed. %M 35960595 %R 10.2196/37968 %U https://mental.jmir.org/2022/10/e37968 %U https://doi.org/10.2196/37968 %U http://www.ncbi.nlm.nih.gov/pubmed/35960595 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 10 %P e38715 %T Providing Accessible ReCreation Outdoors–User-Driven Research on Standards: Protocol for Mobile and Web-Based Interviews for Winter Assessments %A Prescott,Mike %A Gamache,Stéphanie %A Mortenson,W Ben %A Best,Krista L %A Grandisson,Marie %A Mostafavi,Mir Abolfazl %A Labbé,Delphine %A Morales,Ernesto %A Mahmood,Atiya %A Borisoff,Jaimie %A Sawatzky,Bonita %A Miller,William C %A Bulk,Laura Yvonne %A Robillard,Julie M %A Routhier,François %+ Center for Interdisciplinary Research in Rehabilitation and Social Integration, Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale-Nationale, 525, boulevard Hamel, Québec, QC, G1M 2S8, Canada, 1 418 529 9141 ext 6256, francois.routhier@rea.ulaval.ca %K parks %K accessibility %K standards %K user-oriented research %K winter %K disability %K access %K participatory %K national parks %K barriers %K participation %K Canada %K national park %K participation %K outdoor %K activity %K standard %K interview %K safe %K virtual %K summer %K data %K mix-method %K development %D 2022 %7 7.10.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Although there have been recent efforts to improve access to Canadian national parks, many remain not fully accessible to people with disabilities. Winter conditions, in particular, present challenges that limit their participation in outdoor activities. Objective: This study aimed to develop a novel method to assess park access during winter, which will inform recommendations for national park standards to meet the needs of all park visitors (regardless of ability) during winter conditions. Methods: A larger participatory mixed methods research project exploring park access was adapted. A 3-phase approach has already been proposed to achieve the study objectives. In the first phase, a scoping review of the existing accessibility standards will be conducted. In the second phase, objective audits of trails and features in 6 parks, 3 in western Canada and 3 in eastern Canada, will be conducted, as well as mobile interviews with 24 various participants in each region regarding their experiences of and recommendations for improving the park’s accessibility. In the final phase, a Delphi participatory consensus development process will be used, based on the data gathered in the first 2 phases, to prioritize recommendations for standards. This paper will focus on the second phase of the study, specifically on whether the in-person winter mobile interviews (ie, walking and wheeling interviews) with people who have a wide range of disabilities while visiting 3 parks in 2 provinces were modified. Changes were made to accommodate the extreme winter weather conditions in Quebec while using safe and informative data collection methods. Results: In Quebec, one park, where winter conditions are safer, has been assessed in person (n=4). Web-based interviews were used to facilitate the assessment of other winter and summer conditions in two other parks (n=8). Winter and web-based interviews were completed in April 2022. Data are currently being collected and analyzed, and results will be completed by December 2022. Conclusions: We expect that adapting the protocol to gather further information on winter conditions and access to parks will provide high-quality and rich data to better inform park access standards. This participatory mixed methods research will inform the development of park standards that consider the accessibility needs of all people. International Registered Report Identifier (IRRID): DERR1-10.2196/38715 %M 36206037 %R 10.2196/38715 %U https://www.researchprotocols.org/2022/10/e38715 %U https://doi.org/10.2196/38715 %U http://www.ncbi.nlm.nih.gov/pubmed/36206037 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 10 %P e38339 %T Investigating Rewards and Deposit Contract Financial Incentives for Physical Activity Behavior Change Using a Smartphone App: Randomized Controlled Trial %A de Buisonjé,David R %A Reijnders,Thomas %A Cohen Rodrigues,Talia R %A Prabhakaran,Santhanam %A Kowatsch,Tobias %A Lipman,Stefan A %A Bijmolt,Tammo H A %A Breeman,Linda D %A Janssen,Veronica R %A Kraaijenhagen,Roderik A %A Kemps,Hareld M C %A Evers,Andrea W M %+ Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Wassenaarseweg 52, Room 2A22, Leiden, 2333 AK, Netherlands, 31 630665252, d.r.de.buisonje@fsw.leidenuniv.nl %K eHealth %K behavior change %K rewards %K reward learning %K financial incentives %K deposit contracts %K commitment contracts %K physical activity %K mobile phone %D 2022 %7 6.10.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Financial incentive interventions for improving physical activity have proven to be effective but costly. Deposit contracts (in which participants pledge their own money) could be an affordable alternative. In addition, deposit contracts may have superior effects by exploiting the power of loss aversion. Previous research has often operationalized deposit contracts through loss framing a financial reward (without requiring a deposit) to mimic the feelings of loss involved in a deposit contract. Objective: This study aimed to disentangle the effects of incurring actual losses (through self-funding a deposit contract) and loss framing. We investigated whether incentive conditions are more effective than a no-incentive control condition, whether deposit contracts have a lower uptake than financial rewards, whether deposit contracts are more effective than financial rewards, and whether loss frames are more effective than gain frames. Methods: Healthy participants (N=126) with an average age of 22.7 (SD 2.84) years participated in a 20-day physical activity intervention. They downloaded a smartphone app that provided them with a personalized physical activity goal and either required a €10 (at the time of writing: €1=US $0.98) deposit up front (which could be lost) or provided €10 as a reward, contingent on performance. Daily feedback on incentive earnings was provided and framed as either a loss or gain. We used a 2 (incentive type: deposit or reward) × 2 (feedback frame: gain or loss) between-subjects factorial design with a no-incentive control condition. Our primary outcome was the number of days participants achieved their goals. The uptake of the intervention was a secondary outcome. Results: Overall, financial incentive conditions (mean 13.10, SD 6.33 days goal achieved) had higher effectiveness than the control condition (mean 8.00, SD 5.65 days goal achieved; P=.002; ηp2=0.147). Deposit contracts had lower uptake (29/47, 62%) than rewards (50/50, 100%; P<.001; Cramer V=0.492). Furthermore, 2-way analysis of covariance showed that deposit contracts (mean 14.88, SD 6.40 days goal achieved) were not significantly more effective than rewards (mean 12.13, SD 6.17 days goal achieved; P=.17). Unexpectedly, loss frames (mean 10.50, SD 6.22 days goal achieved) were significantly less effective than gain frames (mean 14.67, SD 5.95 days goal achieved; P=.007; ηp2=0.155). Conclusions: Financial incentives help increase physical activity, but deposit contracts were not more effective than rewards. Although self-funded deposit contracts can be offered at low cost, low uptake is an important obstacle to large-scale implementation. Unexpectedly, loss framing was less effective than gain framing. Therefore, we urge further research on their boundary conditions before using loss-framed incentives in practice. Because of limited statistical power regarding some research questions, the results of this study should be interpreted with caution, and future work should be done to confirm these findings. Trial Registration: Open Science Framework Registries osf.io/34ygt; https://osf.io/34ygt %M 36201384 %R 10.2196/38339 %U https://www.jmir.org/2022/10/e38339 %U https://doi.org/10.2196/38339 %U http://www.ncbi.nlm.nih.gov/pubmed/36201384 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 10 %P e35464 %T A Data-Driven Reference Standard for Adverse Drug Reaction (RS-ADR) Signal Assessment: Development and Validation %A Lee,Suehyun %A Lee,Jeong Hoon %A Kim,Grace Juyun %A Kim,Jong-Yeup %A Shin,Hyunah %A Ko,Inseok %A Choe,Seon %A Kim,Ju Han %+ Seoul National University Biomedical Informatics (SNUBI), Division of Biomedical Informatics, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea, 82 010 4636 2227, juhan@snu.ac.kr %K adverse drug reaction %K ADR %K real-world data %K RWD %K real-world evidence %K RWE %K pharmacovigilance %K PV %K reference standard %K pharmacology %K drug reaction %D 2022 %7 6.10.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Pharmacovigilance using real-world data (RWD), such as multicenter electronic health records (EHRs), yields massively parallel adverse drug reaction (ADR) signals. However, proper validation of computationally detected ADR signals is not possible due to the lack of a reference standard for positive and negative associations. Objective: This study aimed to develop a reference standard for ADR (RS-ADR) to streamline the systematic detection, assessment, and understanding of almost all drug-ADR associations suggested by RWD analyses. Methods: We integrated well-known reference sets for drug-ADR pairs, including Side Effect Resource, Observational Medical Outcomes Partnership, and EU-ADR. We created a pharmacovigilance dictionary using controlled vocabularies and systematically annotated EHR data. Drug-ADR associations computed from MetaLAB and MetaNurse analyses of multicenter EHRs and extracted from the Food and Drug Administration Adverse Event Reporting System were integrated as “empirically determined” positive and negative reference sets by means of cross-validation between institutions. Results: The RS-ADR consisted of 1344 drugs, 4485 ADRs, and 6,027,840 drug-ADR pairs with positive and negative consensus votes as pharmacovigilance reference sets. After the curation of the initial version of RS-ADR, novel ADR signals such as “famotidine–hepatic function abnormal” were detected and reasonably validated by RS-ADR. Although the validation of the entire reference standard is challenging, especially with this initial version, the reference standard will improve as more RWD participate in the consensus voting with advanced pharmacovigilance dictionaries and analytic algorithms. One can check if a drug-ADR pair has been reported by our web-based search interface for RS-ADRs. Conclusions: RS-ADRs enriched with the pharmacovigilance dictionary, ADR knowledge, and real-world evidence from EHRs may streamline the systematic detection, evaluation, and causality assessment of computationally detected ADR signals. %M 36201386 %R 10.2196/35464 %U https://www.jmir.org/2022/10/e35464 %U https://doi.org/10.2196/35464 %U http://www.ncbi.nlm.nih.gov/pubmed/36201386 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 10 %P e39856 %T A Positive Emotion–Focused Intervention to Increase Physical Activity After Bariatric Surgery: Protocol for a Pilot Randomized Controlled Trial %A Feig,Emily H %A Harnedy,Lauren E %A Thorndike,Anne N %A Psaros,Christina %A Healy,Brian C %A Huffman,Jeff C %+ Department of Psychiatry, Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, United States, 1 617 724 9140, efeig@mgh.harvard.edu %K behavioral intervention %K physical activity %K positive psychology %K design %K bariatric surgery %K positive %K psychological %K well-being %K weight loss %K intervention %K feasibility %K acceptability %K efficacy %K effect %K obesity %K weight %D 2022 %7 6.10.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Physical activity levels after bariatric surgery are usually low, despite the significant protective health benefits of physical activity in this population. Positive psychological well-being is associated with improved adherence to health behaviors, but bariatric surgery patients often have negative associations with physical activity that prevent sustained engagement. Objective: The Gaining Optimism After weight Loss Surgery (GOALS) pilot randomized controlled trial is aimed at testing a novel intervention to increase physical activity after bariatric surgery, which incorporates positive psychological skill-building with motivational interviewing and goal-setting. Methods: The GOALS trial is a 2-arm, 24-week pilot randomized controlled trial that aims to enroll 58 adults who report less than 200 minutes per week of moderate to vigorous physical activity and a desire to become more active 6-12 months after bariatric surgery. GOALS is testing the feasibility, acceptability, and preliminary efficacy of a positive psychology–motivational interviewing telephone intervention targeting to increase physical activity and associated positive affect. Intervention components include positive psychology, goal-setting, self-monitoring via provided Fitbits, and motivational interviewing to overcome barriers and increase motivation. The intervention is compared to a physical activity education control that includes mailings with psychoeducation around physical activity and provision of a Fitbit. The primary outcomes of the pilot trial are feasibility and acceptability, measured as session completion rates and participant ratings of ease and helpfulness of each session. The main secondary outcome is change in accelerometer-measured moderate to vigorous physical activity post intervention and at 24-week follow-up. Additional outcomes include changes in attitudes related to physical activity, psychological well-being, and physical health measures. Results: This multiphase project was funded in 2020 and institutional review board approval was obtained for the proposed trial in 2021. Recruitment for the randomized controlled trial began in July 2022. Upon completion of the pilot trial, we will examine the feasibility, acceptability, and preliminary efficacy of the intervention. Conclusions: Although bariatric surgery is the most effective treatment available for severe obesity, weight regain occurs, often in the context of low psychological well-being. Many individuals would benefit from learning strategies to increase positive psychological well-being after bariatric surgery, which could help them maintain lifestyle changes. Positive psychology is a novel approach to improve adherence by increasing positive associations with health behaviors including physical activity. The GOALS pilot trial will determine whether this type of intervention is feasible and acceptable to this population and will provide a foundation for a future full-scale randomized controlled efficacy trial. Trial Registration: ClinicalTrials.gov NCT04868032; https://clinicaltrials.gov/ct2/show/NCT04868032 International Registered Report Identifier (IRRID): PRR1-10.2196/39856 %M 36201380 %R 10.2196/39856 %U https://www.researchprotocols.org/2022/10/e39856 %U https://doi.org/10.2196/39856 %U http://www.ncbi.nlm.nih.gov/pubmed/36201380 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 7 %N 4 %P e34650 %T Exploring the Experiences and Perspectives of Insulin Therapy in Type 2 Diabetes via Web-Based UK Diabetes Health Forums: Qualitative Thematic Analysis of Threads %A Allen-Taylor,Maya %A Ryan,Laura %A Winkley,Kirsty %A Upsher,Rebecca %+ Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, James Clerk Maxwell Building, 47 Waterloo Road, London, SE1 8WA, United Kingdom, 44 20 7836 5454, m.allen-taylor@kcl.ac.uk %K type 2 diabetes %K adults %K qualitative %K insulin %K internet %K web-based %D 2022 %7 5.10.2022 %9 Original Paper %J JMIR Diabetes %G English %X Background: Despite the advent of type 2 diabetes (T2D) remission strategies and novel therapeutic agents, many individuals with T2D will require insulin treatment to achieve target glycemia, with the aim of preventing or delaying diabetes complications. However, insulin refusal and cessation of treatment in this group are common, and their needs are underreported and relatively unexplored. Objective: This study aimed to explore the experiences and perspectives of individuals with T2D for whom insulin therapy is indicated as expressed on web-based health forums, in order to inform the development of evidence-based structured educational and support strategies and improve health care provider awareness. Methods: Retrospective archived forum threads from the 2 largest, freely and publicly accessible diabetes health forums in the United Kingdom were screened over a 12-month period (August 2019-2020). The Diabetes UK and Diabetes.co.uk forums were searched for relevant threads. A total of 3 independent researchers analyzed the forum threads and posts via thematic analysis. Pertinent themes were identified and illustrated by paraphrasing members’ quotes to ensure anonymity. A total of 299 posts from 29 threads from Diabetes UK and 295 posts from 28 threads Diabetes.co.uk were analyzed over the study period. In all, 57 threads met the inclusion criteria and were included in the final analysis. Results: Four overarching themes were generated to illustrate the unmet needs that prompted members to seek information, advice, and support regarding insulin therapy outside of their usual care provision via the forums: empowerment through sharing self-management strategies, seeking and providing extended lifestyle advice, relationships with health care professionals, and a source of psychological peer support. Conclusions: This is the first study to collect data from web-based health forums to characterize the experiences and perspectives of people with T2D for whom insulin therapy is indicated. The observed naturalistic conversations have generated useful insights; our findings suggest that there are significant unmet self-management and psychological needs within this group that are not being met elsewhere, prompting the seeking of information and support on the web. These include practical aspects such as insulin injection technique, storage and dose titration, driving and travel considerations, the emerging use of technology, and a strong interest in the effects of extended lifestyle (diet and activity) approaches to support insulin therapy. In addition, problematic relationships with health care professionals appear to be a barrier to effective insulin therapy for some. In contrast, seeking and offering mutually beneficial, practical, and psychological support from peers was viewed as enabling. The study results will help to directly inform insulin-focused self-management and support strategies to enable individuals in this group to achieve their best outcomes. %M 36197724 %R 10.2196/34650 %U https://diabetes.jmir.org/2022/4/e34650 %U https://doi.org/10.2196/34650 %U http://www.ncbi.nlm.nih.gov/pubmed/36197724 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 10 %P e37406 %T Mining the Gems of a Web-Based Mindfulness Intervention: Qualitative Analysis of Factors Aiding Completion and Implementation %A Yadav,Muskan %A Neate,Sandra %A Hassed,Craig %A Chambers,Richard %A Connaughton,Sherelle %A Nag,Nupur %+ Neuroepidemiology Unit, Melbourne School of Population and Global Health, The University of Melbourne, Level 3, 207 Bouverie Street, Melbourne, 3010, Australia, 61 383447944, nnag@unimelb.edu.au %K digital intervention %K health education %K mindfulness %K online learning %K behavior change %K mental health %K mental well-being %K physical well-being %K meditation %K health promotion %K digital health %K eHealth %K thematic analysis %K attrition %K participation %K involvement %K engagement %K attitude %K perspective %K patient education %K e-learning %K user feedback %D 2022 %7 5.10.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital health interventions provide a cost effective and accessible means for positive behavior change. However, high participant attrition is common and facilitators for implementation of behaviors are not well understood. Objective: The goal of the research was to identify elements of a digital mindfulness course that aided in course completion and implementation of teachings. Methods: Inductive thematic analysis was used to assess participant comments regarding positive aspects of the online mindfulness course Mindfulness for Well-being and Peak Performance. Participants were aged 18 years and older who had self-selected to register and voluntarily completed at least 90% the course. The course comprised educator-guided lessons and discussion forums for participant reflection and feedback. Participant comments from the final discussion forum were analyzed to identify common themes pertaining to elements of the course that aided in course completion and implementation of teachings. Results: Of 3355 course completers, 283 participants provided comments related to the research question. Key themes were (1) benefits from the virtual community, (2) appeal of content, (3) enablers to participation and implementation, and (4) benefits noted in oneself. Of subthemes identified, some, such as community support, variety of easily implementable content, and free content access, align with that reported previously in the literature, while other subthemes, including growing together, repeating the course, evidence-based teaching, and immediate benefits on physical and mental well-being, were novel findings. Conclusions: Themes identified as key elements for aiding participant completion of a mindfulness digital health intervention and the implementation of teachings may inform the effective design of future digital health interventions to drive positive health behaviors. Future research should focus on understanding motivations for participation, identification of effective methods for participant retention, and behavior change techniques to motivate long-term adherence to healthy behaviors. %M 36197709 %R 10.2196/37406 %U https://formative.jmir.org/2022/10/e37406 %U https://doi.org/10.2196/37406 %U http://www.ncbi.nlm.nih.gov/pubmed/36197709 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 10 %P e36275 %T Using Personalized Avatars as an Adjunct to an Adult Weight Loss Management Program: Randomized Controlled Feasibility Study %A Horne,Maria %A Hardy,Maryann %A Murrells,Trevor %A Ugail,Hassan %A Hill,Andrew John %+ Faculty of Medicine and Health, School of Healthcare, University of Leeds, Baines Wing, Leeds, LS2 9JT, United Kingdom, 44 113 343 ext 1230, M.Horne@leeds.ac.uk %K avatar %K feasibility %K obesity %K weight loss %K weight management %D 2022 %7 5.10.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Obesity is a global public health concern. Interventions rely predominantly on managing dietary intake and increasing physical activity; however, sustained adherence to behavioral regimens is often poor. The lack of sustained motivation, self-efficacy, and poor adherence to behavioral regimens are recognized barriers to successful weight loss. Avatar-based interventions achieve better patient outcomes in the management of chronic conditions by promoting more active engagement. Virtual representations of self can affect real-world behavior, acting as a catalyst for sustained weight loss behavior. Objective: We evaluated whether a personalized avatar, offered as an adjunct to an established weight loss program, can increase participant motivation, sustain engagement, optimize service delivery, and improve participant health outcomes. Methods: A feasibility randomized design was used to determine the case for future development and evaluation of avatar-based technology in a randomized controlled trial. Participants were recruited from general practitioner referrals to a 12-week National Health Service weight improvement program. The main outcome measure was weight loss. Secondary outcome measures were quality-of-life and self-efficacy. Quantitative data were subjected to descriptive statistical tests and exploratory comparison between intervention and control arms. Feasibility and acceptability were assessed through interviews and analyzed using framework approach. Health Research Authority ethics approval was granted. Results: Overall, 10 men (n=7, 70% for routine care and avatar and n=3, 30% for routine care) and 33 women (n=23, 70% for intervention and n=10, 30% for routine care) were recruited. Participants’ initial mean weight was greater in the intervention arm than in the routine care arm (126.3 kg vs 122.9 kg); pattern of weight loss was similar across both arms of the study in T0 to T1 period but accelerated in T1 to T2 period for intervention participants, suggesting that access to the self-resembling avatar may promote greater engagement with weight loss initiatives in the short-to-medium term. Mean change in participants’ weight from T0 to T2 was 4.5 kg (95% CI 2.7-6.3) in the routine care arm and 5.3 kg (95% CI 3.9-6.8) in the intervention arm. Quality-of-life and self-efficacy measures demonstrated greater improvement in the intervention arm at both T1 (105.5 for routine care arm and 99.7 for intervention arm) and T2 (100.1 for routine care arm and 81.2 for intervention arm). Overall, 13 participants (n=11, 85% women and n=2, 15% men) and two health care professionals were interviewed about their experience of using the avatar program. Conclusions: Participants found using the personalized avatar acceptable, and feedback reiterated that seeing a future self helped to reinforce motivation to change behavior. This feasibility study demonstrated that avatar-based technology may successfully promote engagement and motivation in weight loss programs, enabling participants to achieve greater weight loss gains and build self-confidence. Trial Registration: ISRCTN Registry 17953876; https://doi.org/10.1186/ISRCTN17953876 %M 36197703 %R 10.2196/36275 %U https://formative.jmir.org/2022/10/e36275 %U https://doi.org/10.2196/36275 %U http://www.ncbi.nlm.nih.gov/pubmed/36197703 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 10 %P e35744 %T Collective Value Promotes the Willingness to Share Provaccination Messages on Social Media in China: Randomized Controlled Trial %A Fu,Chunye %A Lyu,Xiaokang %A Mi,Mingdi %+ Department of Social Psychology, Zhou Enlai School of Government, Nankai University, 38 Tongyan Road, Haihe Education Park, Tianjin, 300350, China, 86 13920214514, luxk@nankai.edu.cn %K individual value %K collective value %K vaccination %K message-sharing willingness %K perceived responsibility %K misinformation %K vaccine misinformation %K public health %K influenza vaccine %K social media %K COVID-19 %D 2022 %7 4.10.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The proliferation of vaccine misinformation on social media has seriously corrupted the public’s confidence in vaccination. Proactively sharing provaccination messages on social media is a cost-effective way to enhance global vaccination rates and resist vaccine misinformation. However, few strategies for encouraging the public to proactively share vaccine-related knowledge on social media have been developed. Objective: This research examines the effect of value type (individual vs collective) and message framing (gain vs loss) on influenza vaccination intention (experiment 1) and the willingness to share provaccination messages (experiment 2) among Chinese adults during the COVID-19 pandemic. The primary aim was to evaluate whether messages that emphasized collective value were more effective in increasing the willingness to share than messages that emphasized individual value. Methods: We enrolled 450 Chinese adults for experiment 1 (n=250, 55.6%) and experiment 2 (n=200, 44.4%). Participants were randomly assigned to individual-gain, individual-loss, collective-gain, or collective-loss conditions with regard to the message in each experiment using the online survey platform’s randomization function. Experiment 1 also included a control group. The primary outcome was influenza vaccination intention in experiment 1 and the willingness to share provaccination messages in experiment 2. Results: The valid sample included 213 adults in experiment 1 (females: n=151, 70.9%; mean age 29 [SD 9] years; at least some college education: n=202, 94.8%; single: n=131, 61.5%) and 171 adults in experiment 2 (females: n=106, 62.0%; mean age 28 [SD 7] years; at least some college education: n=163, 95.3%; single: n=95, 55.6%). Influenza vaccination intention was stronger in the individual-value conditions than in the collective-value conditions (F3,166=4.96, P=.03, η2=0.03). The reverse result was found for the willingness to share provaccination messages (F3,165=6.87, P=.01, η2=0.04). Specifically, participants who received a message emphasizing collective value had a higher intention to share the message than participants who read a message emphasizing individual value (F3,165=6.87, P=.01, η2=0.04), and the perceived responsibility for message sharing played a mediating role (indirect effect=0.23, 95% lower limit confidence interval [LLCI] 0.41, 95% upper limit confidence interval [ULCI] 0.07). In addition, gain framing facilitated influenza vaccination intention more than loss framing (F3,166=5.96, P=.02, η2=0.04). However, experiment 2 did not find that message framing affected message-sharing willingness. Neither experiment found an interaction between value type and message framing. Conclusions: Strengthened individual value rather than collective value is more likely to persuade Chinese adults to vaccinate. However, these adults are more likely to share a message that emphasizes collective rather than individual value, and the perceived responsibility for message sharing plays a mediating role. %M 36067417 %R 10.2196/35744 %U https://formative.jmir.org/2022/10/e35744 %U https://doi.org/10.2196/35744 %U http://www.ncbi.nlm.nih.gov/pubmed/36067417 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 10 %P e37342 %T Guided Internet-Delivered Treatment for Depression: Scoping Review %A Børtveit,Line %A Dechsling,Anders %A Sütterlin,Stefan %A Nordgreen,Tine %A Nordahl-Hansen,Anders %+ Faculty of Health, Welfare and Organisation, Østfold University College, Høgskolen i Østfold, Postboks 700, Halden, 1757, Norway, 47 93203985, linebortveit@gmail.com %K web-based therapy %K computer-assisted therapy %K internet %K digital interventions %K major depression %K mental health %K mobile phone %D 2022 %7 4.10.2022 %9 Review %J JMIR Ment Health %G English %X Background: Studies on guided internet-delivered treatment have demonstrated promising results for patients with depressive disorder. Objective: The aim of this study was to provide an overview of this research area and identify potential gaps in the research. Methods: In this scoping review, web-based databases were used to identify research papers published between 2010 and 2022 where guided internet-delivered treatment was administered to participants with depressive disorders, a standardized rating scale of depressive symptoms was used as the primary outcome measure, and the treatment was compared with a control condition. Results: A total of 111 studies were included, and an overview of the studies was provided. Several gaps in the research were identified regarding the design of the studies, treatments delivered, participant representation, and treatment completion. Conclusions: This review provides a comprehensive overview of the research area, and several research gaps were identified. The use of other designs and active control conditions is recommended. Future studies should provide access to treatment manuals, and more replications should be conducted. Researchers should aim to include underrepresented populations and provide reports of comorbidities. Definitions of adequate dosage, reports of completion rates, and reasons for treatment dropout are recommended for future studies. %M 36194467 %R 10.2196/37342 %U https://mental.jmir.org/2022/10/e37342 %U https://doi.org/10.2196/37342 %U http://www.ncbi.nlm.nih.gov/pubmed/36194467 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 10 %P e39243 %T Conversational Agents in Health Care: Scoping Review of Their Behavior Change Techniques and Underpinning Theory %A Martinengo,Laura %A Jabir,Ahmad Ishqi %A Goh,Westin Wei Tin %A Lo,Nicholas Yong Wai %A Ho,Moon-Ho Ringo %A Kowatsch,Tobias %A Atun,Rifat %A Michie,Susan %A Tudor Car,Lorainne %+ Lee Kong Chian School of Medicine, Nanyang Technological University Singapore, 11 Mandalay Road, Clinical Sciences Building Level 18, Singapore, 308232, Singapore, 65 69047142, lorainne.tudor.car@ntu.edu.sg %K behavior change %K behavior change techniques %K conversational agent %K chatbot %K mHealth %D 2022 %7 3.10.2022 %9 Review %J J Med Internet Res %G English %X Background: Conversational agents (CAs) are increasingly used in health care to deliver behavior change interventions. Their evaluation often includes categorizing the behavior change techniques (BCTs) using a classification system of which the BCT Taxonomy v1 (BCTTv1) is one of the most common. Previous studies have presented descriptive summaries of behavior change interventions delivered by CAs, but no in-depth study reporting the use of BCTs in these interventions has been published to date. Objective: This review aims to describe behavior change interventions delivered by CAs and to identify the BCTs and theories guiding their design. Methods: We searched PubMed, Embase, Cochrane’s Central Register of Controlled Trials, and the first 10 pages of Google and Google Scholar in April 2021. We included primary, experimental studies evaluating a behavior change intervention delivered by a CA. BCTs coding followed the BCTTv1. Two independent reviewers selected the studies and extracted the data. Descriptive analysis and frequent itemset mining to identify BCT clusters were performed. Results: We included 47 studies reporting on mental health (n=19, 40%), chronic disorders (n=14, 30%), and lifestyle change (n=14, 30%) interventions. There were 20/47 embodied CAs (43%) and 27/47 CAs (57%) represented a female character. Most CAs were rule based (34/47, 72%). Experimental interventions included 63 BCTs, (mean 9 BCTs; range 2-21 BCTs), while comparisons included 32 BCTs (mean 2 BCTs; range 2-17 BCTs). Most interventions included BCTs 4.1 “Instruction on how to perform a behavior” (34/47, 72%), 3.3 “Social support” (emotional; 27/47, 57%), and 1.2 “Problem solving” (24/47, 51%). A total of 12/47 studies (26%) were informed by a behavior change theory, mainly the Transtheoretical Model and the Social Cognitive Theory. Studies using the same behavior change theory included different BCTs. Conclusions: There is a need for the more explicit use of behavior change theories and improved reporting of BCTs in CA interventions to enhance the analysis of intervention effectiveness and improve the reproducibility of research. %M 36190749 %R 10.2196/39243 %U https://www.jmir.org/2022/10/e39243 %U https://doi.org/10.2196/39243 %U http://www.ncbi.nlm.nih.gov/pubmed/36190749 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e37900 %T The Impact of a Clinical Decision Support System for Addressing Physical Activity and Healthy Eating During Smoking Cessation Treatment: Hybrid Type I Randomized Controlled Trial %A Minian,Nadia %A Lingam,Mathangee %A Moineddin,Rahim %A Thorpe,Kevin E %A Veldhuizen,Scott %A Dragonetti,Rosa %A Zawertailo,Laurie %A Taylor,Valerie H %A Hahn,Margaret %A deRuiter,Wayne K %A Melamed,Osnat C %A Selby,Peter %+ Nicotine Dependence Service, Centre for Addiction and Mental Health, 1025 Queen Street West, Toronto, ON, M6J 1H1, Canada, 1 416 535 8501 ext 36859, peter.selby@camh.ca %K smoking cessation %K physical activity %K healthy eating %K clinical decision support system %K Canada %K diet %K intervention %K smoking %K primary care %K program %K treatment %K clinical decision support %K health behavior %D 2022 %7 30.9.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: People who smoke have other risk factors for chronic diseases, such as low levels of physical activity and poor diet. Clinical decision support systems (CDSSs) might help health care practitioners integrate interventions for diet and physical activity into their smoking cessation programming but could worsen quit rates. Objective: The aims of this study are to assess the effects of the addition of a CDSS for physical activity and diet on smoking cessation outcomes and to assess the implementation of the study. Methods: We conducted a pragmatic hybrid type I effectiveness-implementation trial with 232 team-based primary care practices in Ontario, Canada, from November 2019 to May 2021. We used a 2-arm randomized controlled trial comparing a CDSS addressing physical activity and diet to treatment as usual and used the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework to measure implementation outcomes. The primary outcome was self-reported 7-day tobacco abstinence at 6 months. Results: We enrolled 5331 participants in the study. Of these, 2732 (51.2%) were randomized to the intervention group and 2599 (48.8%) to the control group. At the 6-month follow-up, 29.7% (634/2137) of respondents in the intervention arm and 27.3% (552/2020) in the control arm reported abstinence from tobacco. After multiple imputation, the absolute group difference was 2.1% (95% CI −0.5 to 4.6; F1,1000.42=2.43; P=.12). Mean exercise minutes changed from 32 (SD 44.7) to 110 (SD 196.1) in the intervention arm and from 32 (SD 45.1) to 113 (SD 195.1) in the control arm (group effect: B=−3.7 minutes; 95% CI −17.8 to 10.4; P=.61). Servings of fruit and vegetables changed from 2.64 servings to 2.42 servings in the intervention group and from 2.52 servings to 2.45 servings in the control group (incidence rate ratio for intervention group=0.98; 95% CI 0.93-1.02; P=.35). Conclusions: A CDSS for physical activity and diet may be added to a smoking cessation program without affecting the outcomes. Further research is needed to improve the impact of integrated health promotion interventions in primary care smoking cessation programs. Trial Registration: ClinicalTrials.gov NCT04223336 https://www.clinicaltrials.gov/ct2/show/NCT04223336 International Registered Report Identifier (IRRID): RR2-10.2196/19157 %M 36178716 %R 10.2196/37900 %U https://www.jmir.org/2022/9/e37900 %U https://doi.org/10.2196/37900 %U http://www.ncbi.nlm.nih.gov/pubmed/36178716 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e37848 %T An Internet-Based Education Program for Human Papillomavirus Vaccination Among Female College Students in Mainland China: Application of the Information-Motivation-Behavioral Skills Model in a Cluster Randomized Trial %A Si,Mingyu %A Su,Xiaoyou %A Jiang,Yu %A Wang,Wenjun %A Zhang,Xi %A Gu,Xiaofen %A Ma,Li %A Li,Jing %A Zhang,Shaokai %A Ren,Zefang %A Liu,Yuanli %A Qiao,Youlin %+ School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, 5 DongDanSanTiao, Dongcheng District, Beijing, 100730, China, 86 10 65256070, suxiaoyou@hotmail.com %K human papillomavirus vaccination %K internet-based education %K information-motivation-behavioral skills model %K female college students %K China %D 2022 %7 30.9.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Patients diagnosed with cervical cancer in the last 2 decades were mainly young females. Human papillomavirus (HPV) vaccination is the most radical way to prevent HPV infection and cervical cancer. However, most female college students in mainland China have not yet been vaccinated, and their relevant knowledge is limited. Theory-based education delivered via the internet is a potentially accessible and useful way to promote HPV vaccination among this population. Objective: This 3-month follow-up study intended to identify the feasibility and efficacy of an information-motivation-behavioral skills (IMB) model–based online intervention for promoting awareness and willingness regarding HPV vaccination among female college students. Methods: A 7-day online HPV education program for female college students in mainland China was developed using a cluster randomized trial design. Recruitment and questionnaire surveys were performed online without face-to-face contact. SPSS 23.0 was used for statistical analysis. The chi-square test and t test were used to compare differences in qualitative and continuous variables between intervention and control groups. The generalized estimating equation was used to test the effectiveness of the intervention with a consideration of the time factor. Results: Among 3867 participants, 102 had been vaccinated against HPV before the study (vaccination rate of 2.6%). A total of 3484 participants were followed up after the baseline survey, with no statistical difference in the loss rate between the intervention and control groups during the intervention and follow-up periods. At different follow-up time points, HPV-related knowledge, and the motivation, behavioral skills, and willingness regarding HPV vaccination were higher in the intervention group than in the control group. HPV-related knowledge was statistically different between the 2 groups, while the motivation, behavioral skills, and willingness regarding HPV vaccination only showed statistical differences right after the intervention, reaching a peak right after the intervention and then gradually reducing over time. Furthermore, there was no statistical difference in the HPV vaccination rate between the 2 groups. Conclusions: IMB model–based online education could be a promising way to increase the HPV vaccination rate and reduce the burden of HPV infection and cervical cancer among high-risk female college students in China. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900025476; http://www.chictr.org.cn/showprojen.aspx? proj=42672 International Registered Report Identifier (IRRID): RR2-DOI:10.1186/s12889-019-7903-x %M 36178723 %R 10.2196/37848 %U https://www.jmir.org/2022/9/e37848 %U https://doi.org/10.2196/37848 %U http://www.ncbi.nlm.nih.gov/pubmed/36178723 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 5 %N 3 %P e40171 %T A Social Media–Based Intervention for Chinese American Caregivers of Persons With Dementia: Protocol Development %A Hong,Y Alicia %A Shen,Kang %A Lu,Huixing Kate %A Chen,Hsiaoyin %A Gong,Yang %A Ta Park,Van %A Han,Hae-Ra %+ Department of Health Administration and Policy, College of Public Health, George Mason University, 4400 University Dr. MS 1j3, Fairfax, VA, 22030, United States, 1 703 993 1929, yhong22@gmu.edu %K Alzheimer disease %K dementia %K caregivers %K Chinese Americans %K mHealth intervention %K mobile health %K WeChat %K social media %K aging %D 2022 %7 29.9.2022 %9 Original Paper %J JMIR Aging %G English %X Background: Racial/ethnic minority and immigrant caregivers of persons with dementia experience high rates of psychosocial stress and adverse health outcomes. Few culturally tailored mobile health (mHealth) programs were designed for these vulnerable populations. Objective: This study reports the development of a culturally tailored mHealth program called Wellness Enhancement for Caregivers (WECARE) to improve caregiving skills, reduce distress, and improve the psychosocial well-being of Chinese American family caregivers of persons with dementia. Methods: Community-based user-centered design principles were applied in the program development. First, the structure and curriculum of the WECARE program were crafted based on existing evidence-based interventions for caregivers with input from 4 experts. Second, through working closely with 8 stakeholders, we culturally adapted evidence-based programs into multimedia program components. Lastly, 5 target users tested the initial WECARE program; their experience and feedback were used to further refine the program. Results: The resulting WECARE is a 7-week mHealth program delivered via WeChat, a social media app highly popular in Chinese Americans. By subscribing to the official WECARE account, users can receive 6 interactive multimedia articles pushed to their WeChat accounts each week for 7 weeks. The 7 major themes include (1) facts of dementia and caregiving; (2) the enhancement of caregiving skills; (3) effective communication with health care providers, care partners, and family members; (4) problem-solving skills for caregiving stress management; (5) stress reduction and depression prevention; (6) the practice of self-care and health behaviors; and (7) social support and available resources. Users also have the option of joining group chats for peer support. The WECARE program also includes a back-end database that manages intervention delivery and tracks user engagement. Conclusions: The WECARE program represents one of the first culturally tailored social media–based interventions for Chinese American caregivers of persons with dementia. It demonstrates the use of community-based user-centered design principles in developing an mHealth intervention program in underserved communities. We call for more cultural adaptation and development of mHealth interventions for immigrant and racial/ethnic minority caregivers of persons with dementia. %M 36173667 %R 10.2196/40171 %U https://aging.jmir.org/2022/3/e40171 %U https://doi.org/10.2196/40171 %U http://www.ncbi.nlm.nih.gov/pubmed/36173667 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 9 %P e39633 %T Acceptability and Feasibility of the Telehealth Bariatric Behavioral Intervention to Increase Physical Activity: Protocol for a Single-Case Experimental Study %A Baillot,Aurélie %A St-Pierre,Maxime %A Lapointe,Josyanne %A Bernard,Paquito %A Bond,Dale %A Romain,Ahmed Jérôme %A Garneau,Pierre Y %A Biertho,Laurent %A Tchernof,André %A Blackburn,Patricia %A Langlois,Marie-France %A Brunet,Jennifer %+ Nursing Department, Université du Québec en Outaouais, 283, boulevard Alexandre-Taché, Gatineau, QC, J8X 3X7, Canada, 1 819 595 3900 ext 1995, aurelie.baillot@uqo.ca %K behavior change intervention %K bariatric surgery %K physical activity %K telehealth %K single-case experimental design %K self-determination %K self-efficacy %K behavior change techniques %K mobile phone %D 2022 %7 29.9.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Regular physical activity (PA) is recommended to optimize weight and health outcomes in patients who have undergone metabolic and bariatric surgery (MBS). However, >70% of patients have low PA levels before MBS that persist after MBS. Although behavioral interventions delivered face-to-face have shown promise for increasing PA among patients who have undergone MBS, many may experience barriers, preventing enrollment into and adherence to such interventions. Delivering PA behavior change interventions via telehealth to patients who have undergone MBS may be an effective strategy to increase accessibility and reach, as well as adherence. Objective: This paper reports the protocol for a study that aims to assess the feasibility and acceptability of the protocol or methods and the Telehealth Bariatric Behavioral Intervention (TELE-BariACTIV). The intervention is designed to increase moderate-to-vigorous intensity PA (MVPA) in patients awaiting bariatric surgery and is guided by a multitheory approach and a patient perspective. Another objective is to estimate the effect of the TELE-BariACTIV intervention on presurgical MVPA to determine the appropriate sample size for a multicenter trial. Methods: This study is a multicenter trial using a repeated (ABAB’A) single-case experimental design. The A phases are observational phases without intervention (A1=pre-MBS phase; A2=length personalized according to the MBS date; A3=7 months post-MBS phase). The B phases are interventional phases with PA counseling (B1=6 weekly pre-MBS sessions; B2=3 monthly sessions starting 3 months after MBS). The target sample size is set to 12. Participants are inactive adults awaiting sleeve gastrectomy who have access to a computer with internet and an interface with a camera. The participants are randomly allocated to a 1- or 2-week baseline period (A1). Protocol and intervention feasibility and acceptability (primary outcomes) will be assessed by recording missing data, refusal, recruitment, retention, attendance, and attrition rates, as well as via web-based acceptability questionnaires and semistructured interviews. Data collected via accelerometry (7-14 days) on 8 occasions and via questionnaires on 10 occasions will be analyzed to estimate the effect of the intervention on MVPA. Generalization measures assessing the quality of life, anxiety and depressive symptoms, and theory-based constructs (ie, motivational regulations for PA, self-efficacy to overcome barriers to PA, basic psychological needs satisfaction and frustration, PA enjoyment, and social support for PA; secondary outcomes for a future large-scale trial) will be completed via web-based questionnaires on 6-10 occasions. The institutional review board provided ethics approval for the study in June 2021. Results: Recruitment began in September 2021, and all the participants were enrolled (n=12). Data collection is expected to end in fall 2023, depending on the MBS date of the recruited participants. Conclusions: The TELE-BariACTIV intervention has the potential for implementation across multiple settings owing to its collaborative construction that can be offered remotely. International Registered Report Identifier (IRRID): DERR1-10.2196/39633 %M 36173668 %R 10.2196/39633 %U https://www.researchprotocols.org/2022/9/e39633 %U https://doi.org/10.2196/39633 %U http://www.ncbi.nlm.nih.gov/pubmed/36173668 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e39686 %T Digital Interventions for Psychological Well-being in University Students: Systematic Review and Meta-analysis %A Ferrari,Madeleine %A Allan,Stephanie %A Arnold,Chelsea %A Eleftheriadis,Dina %A Alvarez-Jimenez,Mario %A Gumley,Andrew %A Gleeson,John F %+ Healthy Brain and Mind Research Centre, Australian Catholic University, 25a Barker Road, Strathfield campus, Sydney, 2135, Australia, 61 0297014726, madeleine.ferrari@acu.edu.au %K psychological well-being %K mental health %K university students %K higher education students %K college students %K digital intervention %K web-based intervention %K mobile phone %K meta-analysis %K systematic review %D 2022 %7 28.9.2022 %9 Review %J J Med Internet Res %G English %X Background: Life at university provides important opportunities for personal growth; however, this developmental phase also coincides with the peak period of risk for the onset of mental health disorders. In addition, specific university lifestyle factors, including impaired sleep and academic and financial stress, are known to exacerbate psychological distress in students. As a result, university students have been identified as a vulnerable population who often experience significant barriers to accessing psychological treatment. Digital psychological interventions are emerging as a promising solution for this population, but their effectiveness remains unclear. Objective: This systematic review and meta-analysis aimed to assess digital interventions targeting psychological well-being among university students. Methods: Database searches were conducted on December 2, 2021, via Embase, MEDLINE, PsycINFO, and Web of Science. Results: A total of 13 eligible studies were identified, 10 (77%) of which were included in the meta-analysis. Mean pre-post effect sizes indicated that such interventions led to small and significant improvement in psychological well-being (Hedges g=0.32, 95% CI 0.23-0.4; P<.001). These effects remained, albeit smaller, when studies that included a wait-list control group were excluded (Hedges g=0.22, 95% CI 0.08-0.35; P=.002). An analysis of acceptance and commitment therapy approaches revealed small and significant effects (k=6; Hedges g=0.35, 95% CI 0.25-0.45; P<.001). Conclusions: Digital psychological interventions hold considerable promise for university students, although features that optimize service delivery and outcomes require further assessment. Trial Registration: PROSPERO CRD42020196654; https:/www.crd.york.ac.uk/prospero/display_record.php?RecordID=196654 %M 36169988 %R 10.2196/39686 %U https://www.jmir.org/2022/9/e39686 %U https://doi.org/10.2196/39686 %U http://www.ncbi.nlm.nih.gov/pubmed/36169988 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e37776 %T Trends in Effectiveness of Organizational eHealth Interventions in Addressing Employee Mental Health: Systematic Review and Meta-analysis %A Stratton,Elizabeth %A Lampit,Amit %A Choi,Isabella %A Malmberg Gavelin,Hanna %A Aji,Melissa %A Taylor,Jennifer %A Calvo,Rafael A %A Harvey,Samuel B %A Glozier,Nick %+ Dyson School of Design Engineering, Imperial College London, Imperial College Rd, South Kensington,, London, SW7 9EG, United Kingdom, 44 20 7594 888, r.calvo@imperial.ac.uk %K eHealth %K mental health %K employee %K systematic review %K mobile phone %D 2022 %7 27.9.2022 %9 Review %J J Med Internet Res %G English %X Background: Mental health conditions are considered the leading cause of disability, sickness absence, and long-term work incapacity. eHealth interventions provide employees with access to psychological assistance. There has been widespread implementation and provision of eHealth interventions in the workplace as an inexpensive and anonymous way of addressing common mental disorders. Objective: This updated review aimed to synthesize the literature on the efficacy of eHealth interventions for anxiety, depression, and stress outcomes in employee samples in organizational settings and evaluate whether their effectiveness has improved over time. Methods: Systematic searches of relevant articles published from 2004 to July 2020 of eHealth intervention trials (app- or web-based) focusing on the mental health of employees were conducted. The quality and bias of all studies were assessed. We extracted means and SDs from publications by comparing the differences in effect sizes (Hedge g) in standardized mental health outcomes. We meta-analyzed these data using a random-effects model. Results: We identified a tripling of the body of evidence, with 75 trials available for meta-analysis from a combined sample of 14,747 articles. eHealth interventions showed small positive effects for anxiety (Hedges g=0.26, 95% CI 0.13-0.39; P<.001), depression (Hedges g=0.26, 95% CI 0.19-0.34; P<.001), and stress (Hedges g=0.25, 95% CI 0.17-0.34; P<.001) in employees’ after intervention, with similar effects seen at the medium-term follow-up. However, there was evidence of no increase in the effectiveness of these interventions over the past decade. Conclusions: This review and meta-analysis confirmed that eHealth interventions have a small positive impact on reducing mental health symptoms in employees. Disappointingly, we found no evidence that, despite the advances in technology and the enormous resources in time, research, and finance devoted to this area for over a decade, better interventions are being produced. Hopefully, these small effect sizes do not represent optimum outcomes in organizational settings. Trial Registration: PROSPERO CRD42020185859; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=185859 %M 36166285 %R 10.2196/37776 %U https://www.jmir.org/2022/9/e37776 %U https://doi.org/10.2196/37776 %U http://www.ncbi.nlm.nih.gov/pubmed/36166285 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e38697 %T Effectiveness of eHealth Self-management Interventions in Patients With Heart Failure: Systematic Review and Meta-analysis %A Liu,Siru %A Li,Jili %A Wan,Ding-yuan %A Li,Runyi %A Qu,Zhan %A Hu,Yundi %A Liu,Jialin %+ Department of Medical Informatics, West China Hospital, Sichuan University, No 37 Guoxue Road, Chengdu, 610041, China, 86 02885422306, dljl8@163.com %K heart failure %K eHealth %K self-management %K systematic review %K cardiology %K cardiovascular %K morbidity %D 2022 %7 26.9.2022 %9 Review %J J Med Internet Res %G English %X Background: Heart failure (HF) is a common clinical syndrome associated with substantial morbidity, a heavy economic burden, and high risk of readmission. eHealth self-management interventions may be an effective way to improve HF clinical outcomes. Objective: The aim of this study was to systematically review the evidence for the effectiveness of eHealth self-management in patients with HF. Methods: This study included only randomized controlled trials (RCTs) that compared the effects of eHealth interventions with usual care in adult patients with HF using searches of the EMBASE, PubMed, CENTRAL (Cochrane Central Register of Controlled Trials), and CINAHL databases from January 1, 2011, to July 12, 2022. The Cochrane Risk of Bias tool (RoB 2) was used to assess the risk of bias for each study. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) criteria were used to rate the certainty of the evidence for each outcome of interest. Meta-analyses were performed using Review Manager (RevMan v.5.4) and R (v.4.1.0 x64) software. Results: In total, 24 RCTs with 9634 participants met the inclusion criteria. Compared with the usual-care group, eHealth self-management interventions could significantly reduce all-cause mortality (odds ratio [OR] 0.83, 95% CI 0.71-0.98, P=.03; GRADE: low quality) and cardiovascular mortality (OR 0.74, 95% CI 0.59-0.92, P=.008; GRADE: moderate quality), as well as all-cause readmissions (OR 0.82, 95% CI 0.73-0.93, P=.002; GRADE: low quality) and HF-related readmissions (OR 0.77, 95% CI 0.66-0.90, P<.001; GRADE: moderate quality). The meta-analyses also showed that eHealth interventions could increase patients’ knowledge of HF and improve their quality of life, but there were no statistically significant effects. However, eHealth interventions could significantly increase medication adherence (OR 1.82, 95% CI 1.42-2.34, P<.001; GRADE: low quality) and improve self-care behaviors (standardized mean difference –1.34, 95% CI –2.46 to –0.22, P=.02; GRADE: very low quality). A subgroup analysis of primary outcomes regarding the enrolled population setting found that eHealth interventions were more effective in patients with HF after discharge compared with those in the ambulatory clinic setting. Conclusions: eHealth self-management interventions could benefit the health of patients with HF in various ways. However, the clinical effects of eHealth interventions in patients with HF are affected by multiple aspects, and more high-quality studies are needed to demonstrate effectiveness. %M 36155484 %R 10.2196/38697 %U https://www.jmir.org/2022/9/e38697 %U https://doi.org/10.2196/38697 %U http://www.ncbi.nlm.nih.gov/pubmed/36155484 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e39800 %T A Web-Delivered, Clinician-Led Group Exercise Intervention for Older Adults With Type 2 Diabetes: Single-Arm Pre-Post Intervention %A Kirwan,Morwenna %A Chiu,Christine L %A Laing,Thomas %A Chowdhury,Noureen %A Gwynne,Kylie %+ Faculty of Medicine, Health and Human Sciences, Macquarie University, 75 Talavera Road, Macquarie Park, Australia, 61 0428999072, morwenna.kirwan@mq.edu.au %K exercise %K fitness %K diabetic %K physical activity %K diabetes %K functional fitness %K community-based %K older adult %K videoconference %K online %K web-based %K elder %K geriatric %K gerontology %K balance %K movement %K internet-based %K eHealth %K digital health %K weight %K patient education %K translational %D 2022 %7 23.9.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The COVID-19 pandemic created unprecedented shifts in the way health programs and services are delivered. A national lockdown to prevent the spread of COVID-19 in Australia was introduced in March 2020. This lockdown included the closure of exercise clinics, fitness centers, and other community spaces, which, before the pandemic, were used to deliver Beat It. Beat It is an 8-week in-person, community-based, and clinician-led group exercise and education program for adults self-managing diabetes. To continue offering Beat It, it was adapted from an in-person program to a fully web-based supervised group exercise program for adults with type 2 diabetes (T2DM). Objective: This study aims to assess whether the Beat It Online program produced comparable health outcomes to the Beat It in-person program in terms of improving physical fitness (muscular strength and power, aerobic endurance, balance, and flexibility) and waist circumference in older adults with T2DM. Methods: Australians with T2DM who were aged ≥60 years were included. They were enrolled in Beat It Online, a twice-weekly supervised group exercise and education program conducted via videoconference over 8 weeks. Anthropometric measurements and physical fitness parameters were assessed at baseline and completion. The adaptations to Beat It are reported using the Model for Adaptation, Design, and Impact, including the type of changes (what, where, when, and for whom), the criteria for making those changes (why and how), and the intended and unintended outcomes. The intended outcomes were comparable functional fitness as well as physical and mental health improvements across demographics and socioeconomic status. Results: A total of 171 adults (mean 71, SD 5.6 years; n=54, 31.6% male) with T2DM were included in the study, with 40.4% (n=69) residing in lower socioeconomic areas. On the completion of the 8-week program, significant improvements in waist circumference, aerobic capacity, muscular strength, flexibility, and balance were observed in both male and female participants (all P<.001). The Model for Adaptation, Design, and Impact reports on 9 clinical, practical, and technical aspects of Beat It that were adapted for web-based delivery. Conclusions: This study found that Beat It Online was just as effective as the in-person program. This adapted program produced comparable health benefits across demographics and socioeconomic status. This study offers important findings for practitioners and policy makers seeking to maintain independence of older people with T2DM, reversing frailty and maximizing functional and physical fitness, while improving overall quality of life. Beat It Online offers a flexible and inclusive solution with significant physical and mental health benefits to individuals. Further evaluation of Beat It (both in-person and Online) adapted for culturally and linguistically diverse communities will provide greater insights into the efficacy of this promising program. %M 36149745 %R 10.2196/39800 %U https://www.jmir.org/2022/9/e39800 %U https://doi.org/10.2196/39800 %U http://www.ncbi.nlm.nih.gov/pubmed/36149745 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e39741 %T Long-term Weight Loss in a Primary Care–Anchored eHealth Lifestyle Coaching Program: Randomized Controlled Trial %A Hesseldal,Laura %A Christensen,Jeanette Reffstrup %A Olesen,Thomas Bastholm %A Olsen,Michael Hecht %A Jakobsen,Pernille Ravn %A Laursen,Ditte Hjorth %A Lauridsen,Jørgen Trankjær %A Nielsen,Jesper Bo %A Søndergaard,Jens %A Brandt,Carl Joakim %+ Research Unit for General Practice, Department of Public Health, University of Southern Denmark, WP 9, J. B. Winsløws Vej 9A, 5000 Odense, Odense, 5000, Denmark, 45 314919945, lhesseldal@health.sdu.dk %K obesity %K digital behavioral coaching %K health behavior change %K interactive advice %K lifestyle change %K mobile intervention %K patient engagement %K telemedicine %K eHealth %K digital health %K digital coach %K weight loss %K coaching %K training %K engagement %K behavior changes %K diabetes %K type 2 diabetes %K T2D %D 2022 %7 23.9.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Long-term weight loss in people living with obesity can reduce the risk and progression of noncommunicable diseases. Observational studies suggest that digital coaching can lead to long-term weight loss. Objective: We investigated whether an eHealth lifestyle coaching program for people living with obesity with or without type 2 diabetes led to significant, long-term (12-month) weight loss compared to usual care. Methods: In a randomized controlled trial that took place in 50 municipalities in Denmark, 340 people living with obesity with or without type 2 diabetes were enrolled from April 16, 2018, to April 1, 2019, and randomized via an automated computer algorithm to an intervention (n=200) or a control (n=140) group. Patients were recruited via their general practitioners, the Danish diabetes organization, and social media. The digital coaching intervention consisted of an initial 1-hour face-to-face motivational interview followed by digital coaching using behavioral change techniques enabled by individual live monitoring. The primary outcome was change in body weight from baseline to 12 months. Results: Data were assessed for 200 participants, including 127 from the intervention group and 73 from the control group, who completed 12 months of follow-up. After 12 months, mean body weight and BMI were significantly reduced in both groups but significantly more so in the intervention group than the control group (–4.5 kg, 95% CI –5.6 to –3.4 vs –1.5 kg, 95% CI –2.7 to –0.2, respectively; P<.001; and –1.5 kg/m2, 95% CI –1.9 to –1.2 vs –0.5 kg/m2, 95% CI –0.9 to –0.1, respectively; P<.001). Hemoglobin A1c was significantly reduced in both the intervention (–6.0 mmol/mol, 95% CI –7.7 to –4.3) and control (–4.9 mmol/mol, 95% CI –7.4 to –2.4) groups, without a significant group difference (all P>.46). Conclusions: Compared to usual care, digital lifestyle coaching can induce significant weight loss for people living with obesity, both with and without type 2 diabetes, after 12 months. Trial Registration: ClinicalTrials.gov NCT03788915; https://clinicaltrials.gov/ct2/show/NCT03788915 %M 36149735 %R 10.2196/39741 %U https://www.jmir.org/2022/9/e39741 %U https://doi.org/10.2196/39741 %U http://www.ncbi.nlm.nih.gov/pubmed/36149735 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 9 %P e38067 %T Assessing the Impact of Conversational Artificial Intelligence in the Treatment of Stress and Anxiety in Aging Adults: Randomized Controlled Trial %A Danieli,Morena %A Ciulli,Tommaso %A Mousavi,Seyed Mahed %A Silvestri,Giorgia %A Barbato,Simone %A Di Natale,Lorenzo %A Riccardi,Giuseppe %+ Signal & Interactive Systems Lab, Dipartimento di Ingegneria e Scienze dell'Informazione, Università degli Studi di Trento, via Sommarive 9, Povo di Trento - Trento, 38123, Italy, 39 5381237 ext 686, morena.danieli@unitn.it %K mental health care %K conversational artificial intelligence %K mobile health %K mHealth %K personal health care agent %D 2022 %7 23.9.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: While mental health applications are increasingly becoming available for large populations of users, there is a lack of controlled trials on the impacts of such applications. Artificial intelligence (AI)-empowered agents have been evaluated when assisting adults with cognitive impairments; however, few applications are available for aging adults who are still actively working. These adults often have high stress levels related to changes in their work places, and related symptoms eventually affect their quality of life. Objective: We aimed to evaluate the contribution of TEO (Therapy Empowerment Opportunity), a mobile personal health care agent with conversational AI. TEO promotes mental health and well-being by engaging patients in conversations to recollect the details of events that increased their anxiety and by providing therapeutic exercises and suggestions. Methods: The study was based on a protocolized intervention for stress and anxiety management. Participants with stress symptoms and mild-to-moderate anxiety received an 8-week cognitive behavioral therapy (CBT) intervention delivered remotely. A group of participants also interacted with the agent TEO. The participants were active workers aged over 55 years. The experimental groups were as follows: group 1, traditional therapy; group 2, traditional therapy and mobile health (mHealth) agent; group 3, mHealth agent; and group 4, no treatment (assigned to a waiting list). Symptoms related to stress (anxiety, physical disease, and depression) were assessed prior to treatment (T1), at the end (T2), and 3 months after treatment (T3), using standardized psychological questionnaires. Moreover, the Patient Health Questionnaire-8 and General Anxiety Disorders-7 scales were administered before the intervention (T1), at mid-term (T2), at the end of the intervention (T3), and after 3 months (T4). At the end of the intervention, participants in groups 1, 2, and 3 filled in a satisfaction questionnaire. Results: Despite randomization, statistically significant differences between groups were present at T1. Group 4 showed lower levels of anxiety and depression compared with group 1, and lower levels of stress compared with group 2. Comparisons between groups at T2 and T3 did not show significant differences in outcomes. Analyses conducted within groups showed significant differences between times in group 2, with greater improvements in the levels of stress and scores related to overall well-being. A general worsening trend between T2 and T3 was detected in all groups, with a significant increase in stress levels in group 2. Group 2 reported higher levels of perceived usefulness and satisfaction. Conclusions: No statistically significant differences could be observed between participants who used the mHealth app alone or within the traditional CBT setting. However, the results indicated significant differences within the groups that received treatment and a stable tendency toward improvement, which was limited to individual perceptions of stress-related symptoms. Trial Registration: ClinicalTrials.gov NCT04809090; https://clinicaltrials.gov/ct2/show/NCT04809090 %M 36149730 %R 10.2196/38067 %U https://mental.jmir.org/2022/9/e38067 %U https://doi.org/10.2196/38067 %U http://www.ncbi.nlm.nih.gov/pubmed/36149730 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e40141 %T Sustainability of Weight Loss Through Smartphone Apps: Systematic Review and Meta-analysis on Anthropometric, Metabolic, and Dietary Outcomes %A Chew,Han Shi Jocelyn %A Koh,Wee Ling %A Ng,Janelle Shaina Hui Yi %A Tan,Ker Kan %+ Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 3, Clinical Research Centre, Block MD11, 10 Medical Drive, Singapore, 117597, Singapore, 65 65168687, jocelyn.chew.hs@nus.edu.sg %K smartphone app %K mobile app %K mobile health %K mHealth %K eHealth %K weight management %K weight loss %K obesity %K app %K diet %K eating %K mobile phone %D 2022 %7 21.9.2022 %9 Review %J J Med Internet Res %G English %X Background: Evidence on the long-term effects of weight management smartphone apps on various weight-related outcomes remains scarce. Objective: In this review, we aimed to examine the effects of smartphone apps on anthropometric, metabolic, and dietary outcomes at various time points. Methods: Articles published from database inception to March 10, 2022 were searched, from 7 databases (Embase, CINAHL, PubMed, PsycINFO, Cochrane Library, Scopus, and Web of Science) using forward and backward citation tracking. All randomized controlled trials that reported weight change as an outcome in adults with overweight and obesity were included. We performed separate meta-analyses using random effects models for weight, waist circumference, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, blood glucose level, blood pressure, and total energy intake per day. Methodological quality was assessed using the Cochrane Risk of Bias tool. Results: Based on our meta-analyses, weight loss was sustained between 3 and 12 months, with a peak of 2.18 kg at 3 months that tapered down to 1.63 kg at 12 months. We did not find significant benefits of weight loss on the secondary outcomes examined, except for a slight improvement in systolic blood pressure at 3 months. Most of the included studies covered app-based interventions that comprised of components beyond food logging, such as real-time diet and exercise self-monitoring, personalized and remote progress tracking, timely feedback provision, smart devices that synchronized activity and weight data to smartphones, and libraries of diet and physical activity ideas. Conclusions: Smartphone weight loss apps are effective in initiating and sustaining weight loss between 3 and 12 months, but their effects are minimal in their current states. Future studies could consider the various aspects of the socioecological model. Conversational and dialectic components that simulate health coaches could be useful to enhance user engagement and outcome effectiveness. Trial Registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42022329197; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=329197 %M 36129739 %R 10.2196/40141 %U https://www.jmir.org/2022/9/e40141 %U https://doi.org/10.2196/40141 %U http://www.ncbi.nlm.nih.gov/pubmed/36129739 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e39531 %T Pain Reduction With an Immersive Digital Therapeutic Tool in Women Living With Endometriosis-Related Pelvic Pain: Randomized Controlled Trial %A Merlot,Benjamin %A Dispersyn,Garance %A Husson,Zoé %A Chanavaz-Lacheray,Isabella %A Dennis,Thomas %A Greco-Vuilloud,Juliette %A Fougère,Maxime %A Potvin,Stéphane %A Cotty-Eslous,Maryne %A Roman,Horace %A Marchand,Serge %+ Faculté de Médecine et des Sciences de la Santé, Centre de Recherche Clinique du Centre Hospitalier Universitaire de Sherbrooke, Université de Sherbrooke, 3001, 12e Avenue Nord, Sherbrooke, QC, J1H5N4, Canada, 1 8193461110 ext 15889, serge.marchand@usherbrooke.ca %K digital treatment %K digital intervention %K virtual reality %K pelvic pain %K endometriosis %K digital therapeutics %K chronic pain %K randomized controlled trial %K RCT %K pain %K women's health %K eHealth %K digital health %K endometrium %K pelvis %K pelvic %K efficacy %K effectiveness %K gynecology %K gynecologist %K sexual health %K reproductive health %D 2022 %7 21.9.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic pelvic pain is a common and disabling condition in women living with endometriosis. Pharmacological and surgical treatments are not always effective at controlling pain and present important restrictions. Digital therapeutics (DTx) are emerging as major nonpharmacological alternatives that aim to extend the analgesic therapeutic arsenal of patients. Objective: In this randomized controlled trial (RCT), we aimed to measure the immediate and 4-hour persisting effects of a single use 20-minute DTx (Endocare) on pain in women experiencing pelvic pain due to endometriosis. Methods: A total of 45 women with endometriosis participated in a randomized controlled study comparing the analgesic effect of a single use of a virtual reality digital treatment named Endocare (n=23, 51%) to a 2D digital control (n=22, 49%). Perceived pain and pain relief were measured before the treatment and 15, 30, 45, 60, and 240 minutes after the end of the treatment. Results: The clustered posttreatment pain was significantly reduced compared to the pretreatment for both Endocare and the control group (all P<.01). Endocare was significantly more effective than the control group (all P<.01). Endocare decreased the mean pain intensity from 6.0 (SD 1.31) before the treatment to 4.5 (SD 1.71) posttreatment, while the control only decreased it from 5.7 (SD 1.36) to 5.0 (SD 1.43). When comparing each posttreatment measures to the pretest, Endocare significantly reduced pain perception for all points in time up to 4 hours posttreatment. The differences did not reached significance for the control group. Moreover, Endocare was significantly superior to the control group 15, 30, and 45 minutes after the treatment (all P<.001). The mean perceived pain relief was significantly higher for Endocare at 28% (SD 2%) compared to the control, which was 15% (SD 1%) for all the posttreatment measurements (all P>.05). Conclusions: Our study aimed to test the effects of a single use of a DTx treatment on reported pain at different time points in women diagnosed with endometriosis experiencing moderate-to-severe pelvic pain. Importantly, our results support that Endocare, a virtual reality immersive treatment, significantly reduce pain perception compared to a digital control in women living with endometriosis. Interestingly, we are the first to notice that the effect persisted up to 4 hours posttreatment. Trial Registration: ClinicalTrials.gov NCT04650516; https://tinyurl.com/2a2eu9wv %M 36129733 %R 10.2196/39531 %U https://www.jmir.org/2022/9/e39531 %U https://doi.org/10.2196/39531 %U http://www.ncbi.nlm.nih.gov/pubmed/36129733 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 9 %P e39175 %T Effects of the Population-Based “10,000 Steps Duesseldorf” Intervention for Promoting Physical Activity in Community-Dwelling Adults: Protocol for a Nonrandomized Controlled Trial %A Matos Fialho,Paula M %A Günther,Liane %A Schmitz,Elena %A Trümmler,Jannis %A Willemsen,Sorina %A Vomhof,Markus %A Icks,Andrea %A Lang,Alexander %A Kuss,Oliver %A Weyers,Simone %A Pischke,Claudia R %+ Institute of Medical Sociology, Centre for Health and Society, Medical Faculty, Heinrich Heine University Duesseldorf, Moorenstrasse 5, Duesseldorf, 40225, Germany, 49 211 81 08599, ClaudiaRuth.Pischke@med.uni-duesseldorf.de %K physical activity %K population-based complex intervention %K replication study %K multilevel strategy %D 2022 %7 21.9.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: The World Health Organization recommends 150 minutes of moderate to vigorous physical activity (PA), which translates to approximately 7000 to 10,000 steps per day for adults. In Germany, less than half of the population in this age range meets this recommendation, highlighting the need for population-based intervention approaches for promoting daily PA. Objective: The complex community-based PA intervention “10,000 Steps Ghent,” which was originally developed in Belgium and was shown to be effective for PA promotion, has been adapted for implementation and evaluation in 2 German cities. The original Belgian study is currently being replicated, and we aim to examine the effectiveness of the adapted intervention among adults living in intervention city districts in Duesseldorf when compared with those living in control city districts in Wuppertal, over the course of 1 year. Methods: A controlled intervention trial examining the effects of an intervention addressing multiple levels (eg, individual level: website; organizational level: PA promotion in companies; community level: media campaigns and environmental changes) is being conducted. PA and various secondary outcomes will be assessed in 2 random samples of adults aged 25 to 75 years (n=399 in each city) at baseline and after 1 year. Results: Funding for this study was obtained in March 2020. Recruitment for this study and baseline data collection were conducted from May 2021 to March 2022 (as of March 2022, 626 participants were enrolled in the study). The intervention will be implemented in Duesseldorf for 1 year from April 2022 onward, and follow-up assessments will be conducted, starting in May 2023 (until September 2023). Data analysis will be performed in fall 2023, and the results will be published in spring 2024. Conclusions: To our knowledge, this is the first research project (currently underway in Germany) that is aimed at replicating the effects of a complex intervention for PA promotion that was previously shown to be effective in another European country. Trial Registration: German Clinical Trials Register DRKS00024873; https://tinyurl.com/4c9e8azh International Registered Report Identifier (IRRID): DERR1-10.2196/39175 %M 36129746 %R 10.2196/39175 %U https://www.researchprotocols.org/2022/9/e39175 %U https://doi.org/10.2196/39175 %U http://www.ncbi.nlm.nih.gov/pubmed/36129746 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e38497 %T Preliminary Investigation of Shift, a Novel Smartphone App to Support Junior Doctors’ Mental Health and Well-being: Examination of Symptom Progression, Usability, and Acceptability After 1 Month of Use %A Sanatkar,Samineh %A Counson,Isabelle %A Mackinnon,Andrew %A Bartholomew,Alexandra %A Glozier,Nick %A Harvey,Samuel %+ Black Dog Institute, Hospital Road, Randwick, 2031, Australia, 61 02 9065 9179, s.sanatkar@unsw.edu.au %K digital mental health %K mobile health apps %K mHealth apps %K help seeking %K junior doctors %K depression %K mobile phone %D 2022 %7 21.9.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Shift is a novel smartphone app for providing a digital-first mental health resource to junior doctors. It contains psychoeducational material, cognitive behavioral modules, guided mediations, information on common work stressors, and a section on help-seeking options for psychological problems through workplace and private avenues. Objective: This study aimed to conduct a preliminary investigation of the use and potential effectiveness of Shift on depressive and anxiety symptoms (primary outcomes) and work and social functioning, COVID-19 safety concerns, and help seeking (secondary outcomes). This study also sought feedback on whether Shift was seen as an acceptable tool. Methods: Junior doctors in New South Wales, Australia, were approached through promotional activities from the Ministry of Health, specialist medical colleges, and social media advertisements between June and August 2020. Consenting participants provided web-based baseline data, used the Shift app for 30 days, and were asked to complete a poststudy web-based questionnaire. Outcomes were analyzed under the intention-to-treat principle. Results: A total of 222 (n=156 female, 70.3%; mean age 29.2, SD 4.61 years) junior doctors provided full baseline data. Of these, 89.2% (198/222) downloaded the app, logged into the app approximately 6 times (mean 5.68, SD 7.51), completed 4 in-app activities (mean 3.77, SD 4.36), and spent a total of 1 hour on in-app activities (mean 52:23, SD 6:00:18) over 30 days. Postintervention and app use data were provided by 24.3% (54/222) of participants. Depressive and anxiety symptoms significantly decreased between the pre- and postassessment points as expected; however, physicians’ COVID-19 safety concerns significantly increased. Work and social functioning, COVID-19 concerns for family and friends, and help seeking did not change significantly. There was no significant relationship between symptom changes and app use (number of log-ins, days between first and last log-in, and total activity time). Most poststudy completers (31/54, 57%) rated Shift highly or very highly. Conclusions: Despite high levels of nonresponse to the poststudy assessment and increases in COVID-19 safety concerns, junior doctors who used the app reported some improvements in depression and anxiety, which warrant further exploration in a robust manner. %M 36129745 %R 10.2196/38497 %U https://www.jmir.org/2022/9/e38497 %U https://doi.org/10.2196/38497 %U http://www.ncbi.nlm.nih.gov/pubmed/36129745 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 9 %P e37637 %T mHealth-Supported Gender- and Culturally Sensitive Weight Loss Intervention for Hispanic Men With Overweight and Obesity: Single-Arm Pilot Study %A Garcia,David O %A Valdez,Luis A %A Aceves,Benjamin %A Bell,Melanie L %A Rabe,Brooke A %A Villavicencio,Edgar A %A Marrero,David G %A Melton,Forest %A Hooker,Steven P %+ Department of Health Promotion Sciences, Mel and Enid Zuckerman College of Public Health, University of Arizona, 3950 S. Country Club, Suite 330, Tucson, AZ, 85714, United States, 1 520 626 4641, davidogarcia@arizona.edu %K Hispanic %K mobile health %K mHealth %K overweight %K obesity %K weight loss %D 2022 %7 21.9.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Hispanic men have disproportionate rates of overweight and obesity compared with other racial and ethnic subpopulations. However, few weight loss interventions have been developed specifically for this high-risk group. Furthermore, the use of mobile health (mHealth) technologies to support lifestyle behavior changes in weight loss interventions for Hispanic men is largely untested. Objective: This single-arm pilot study examined the feasibility and acceptability of integrating mHealth technology into a 12-week gender- and culturally sensitive weight loss intervention (GCSWLI) for Hispanic men with overweight and obesity. Methods: A total of 18 Hispanic men (mean age 38, SD 10.9 years; mean BMI 34.3, SD 5.5 kg/m²; 10/18, 56% Spanish monolingual) received a GCSWLI, including weekly in-person individual sessions, a daily calorie goal, and prescription of ≥225 minutes of moderate-intensity physical activity per week. mHealth technology support included tailored SMS text messaging, behavior self-monitoring support using Fitbit Charge 2, and weight tracking using a Fitbit Aria Wi-Fi Smart Scale. Changes in weight from baseline to 12 weeks were estimated using a paired 2-tailed t test. Descriptive analyses characterized the use of Fitbit and smart scales. Semistructured interviews were conducted immediately after intervention to assess the participants’ weight loss experiences and perspectives on mHealth technologies. Results: Of 18 participants, 16 (89%) completed the 12-week assessments; the overall attrition rate was 11.1%. The mean weight loss at week 12 was −4.7 kg (95% CI 7.1 to −2.4 kg; P<.001). Participants wore the Fitbit 71.58% (962/1344) of the intervention days and logged their body weight using the smart scale (410/1344, 30.51% of the intervention days). Participants identified barriers to the use of the technology, such as lack of technological literacy and unreliable internet access for the smart scale. Conclusions: Although clinically significant weight loss was achieved by integrating mHealth technology into the GCSWLI, adherence to the prescribed use of technology was modest. Addressing barriers to the use of such technologies identified in our work may help to refine an mHealth intervention approach for Hispanic men. Trial Registration: ClinicalTrials.gov NCT02783521; https://clinicaltrials.gov/ct2/show/NCT02783521 %M 36129735 %R 10.2196/37637 %U https://formative.jmir.org/2022/9/e37637 %U https://doi.org/10.2196/37637 %U http://www.ncbi.nlm.nih.gov/pubmed/36129735 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 9 %P e40924 %T Efficacy and Conflicts of Interest in Randomized Controlled Trials Evaluating Headspace and Calm Apps: Systematic Review %A O'Daffer,Alison %A Colt,Susannah F %A Wasil,Akash R %A Lau,Nancy %+ Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, 1920 Terry Ave, Seattle, WA, 98101, United States, 1 206 884 4211, alison.odaffer@seattlechildrens.org %K mHealth %K psychological interventions %K mobile health %K mental health %K health applications %K health apps %K mindfulness %K meditation app %K digital health application %K digital health intervention %D 2022 %7 20.9.2022 %9 Review %J JMIR Ment Health %G English %X Background: Although there are thousands of mental health apps, 2 apps, Headspace and Calm, claim a large percentage of the marketplace. These two mindfulness and meditation apps have reached tens of millions of active users. To guide consumers, clinicians, and researchers, we performed a systematic review of randomized controlled trials (RCTs) of Headspace and Calm. Objective: Our study aimed to evaluate intervention efficacy, risk of bias, and conflicts of interest (COIs) in the evidence base for Headspace and Calm, the two most popular mental health apps at the time of our search. Methods: To identify studies, we searched academic databases (Google Scholar, MEDLINE, and PsycINFO) and the websites of Headspace and Calm in May 2021 for RCTs of Headspace and Calm testing efficacy via original data collection, published in English in peer-reviewed journals. For each study, we coded (1) study characteristics (eg, participants, sample size, and outcome measures), (2) intervention characteristics (eg, free vs paid version of the app and intended frequency of app usage), (3) all study outcomes, (4) Cochrane risk of bias variables, and (5) COI variables (eg, presence or absence of a preregistration and the presence or absence of a COI statement involving the company). Results: We identified 14 RCTs of Headspace and 1 RCT of Calm. Overall, 93% (13/14) of RCTs of Headspace and 100% (1/1) of RCTs of Calm recruited participants from a nonclinical population. Studies commonly measured mindfulness, well-being, stress, depressive symptoms, and anxiety symptoms. Headspace use improved depression in 75% of studies that evaluated it as an outcome. Findings were mixed for mindfulness, well-being, stress, and anxiety, but at least 40% of studies showed improvement for each of these outcomes. Studies were generally underpowered to detect “small” or “medium” effect sizes. Furthermore, 50% (7/14) of RCTs of Headspace and 0% (0/1) of RCTs of Calm reported a COI that involved Headspace or Calm (the companies). The most common COI was the app company providing premium app access for free for participants, and notably, 14% (2/14) of RCTs of Headspace reported Headspace employee involvement in study design, execution, and data analysis. Only 36% (5/14) of RCTs of Headspace were preregistered, and the 1 RCT of Calm was not preregistered. Conclusions: The empirical research on Headspace appears promising, whereas there is an absence of randomized trials on Calm. Limitations of this study include an inability to compare Headspace and Calm owing to the dearth of RCTs studying Calm and the reliance on author reports to evaluate COIs. When determining whether or not mental health apps are of high quality, identification of high-quality apps and evaluation of their effectiveness and investigators’ COIs should be ensured. %M 36125880 %R 10.2196/40924 %U https://mental.jmir.org/2022/9/e40924 %U https://doi.org/10.2196/40924 %U http://www.ncbi.nlm.nih.gov/pubmed/36125880 %0 Journal Article %@ 2561-9128 %I JMIR Publications %V 5 %N 1 %P e39617 %T The Impact of a Text Messaging Service (Tonsil-Text-To-Me) on Pediatric Perioperative Tonsillectomy Outcomes: Cohort Study With a Historical Control Group %A Wozney,Lori %A Vakili,Negar %A Chorney,Jill %A Clark,Alexander %A Hong,Paul %+ Mental Health and Addictions, Policy and Planning, Nova Scotia Health, 300 Pleasant St, Dartmouth, NS, B2Y 3S3, Canada, 1 9024490603, loriwozney@gmail.com %K tonsillectomy %K otorhinolaryngology %K text messaging %K caregivers %K surgery %K perioperative %K patient discharge %K aftercare %K short messaging service %K pain management %K mobile phone %D 2022 %7 20.9.2022 %9 Original Paper %J JMIR Perioper Med %G English %X Background: Tonsillectomy is a common pediatric surgical procedure performed in North America. Caregivers experience complex challenges in preparing for their child’s surgery and coordinating care at home and, consequently, could benefit from access to educational resources. A previous feasibility study of Tonsil-Text-To-Me, an automated SMS text messaging service that sends 15 time-sensitive activity reminders, links to nutrition and hydration tips, pain management strategies, and guidance on monitoring for complications, showed promising results, with high levels of caregiver satisfaction and engagement. Objective: This study aimed to pilot-test Tonsil-Text-To-Me in a real-world context to determine whether and how it might improve perioperative experiences and outcomes for caregivers and patients. Methods: Caregivers of children aged 3 to 14 years undergoing tonsillectomy were included. Data from a historical control group and an intervention group with the same study parameters (eg, eligibility criteria and surgery team) were compared. Measures included the Parenting Self-Agency Measure, General Health Questionnaire-12, Parents’ Postoperative Pain Measure, Client Satisfaction Questionnaire-8, and engagement analytics, as well as analgesic consumption, pain, child activity level, and health service use. Data were collected on the day before surgery, 3 days after surgery, and 14 days after surgery. Participants in the intervention group received texts starting 2 weeks before surgery up to the eighth day after surgery. Descriptive and inferential statistics were used. Results: In total, 51 caregivers (n=32, 63% control; n=19, 37% intervention) who were predominately women (49/51, 96%), White (48/51, 94%), and employed (42/51, 82%) participated. Intervention group caregivers had a statistically significant positive difference in Parenting Self-Agency Measure scores (P=.001). The mean postoperative pain scores were higher for the control group (mean 10.0, SD 3.1) than for the intervention group (mean 8.5, SD 3.7), both of which were still above the 6/15 threshold for clinically significant pain; however, the difference was not statistically significant (t39=1.446; P=.16). Other positive but nonsignificant trends for the intervention group compared with the control group were observed for the highest level of pain (t39=0.882; P=.38), emergency department visits (χ22=1.3; P=.52; Cramer V=0.19), and other measures. Engagement with resources linked in the texts was moderate, with all but 1 being clicked on for viewing at least once by 79% (15/19) of the participants. Participants rated the intervention as highly satisfactory across all 8 dimensions of the Client Satisfaction Questionnaire (mean 29.4, SD 3.2; out of a possible value of 32.0). Conclusions: This cohort study with a historical control group found that Tonsil-Text-To-Me had a positive impact on caregivers’ perioperative care experience. The small sample size and unclear impacts of COVID-19 on the study design should be considered when interpreting the results. Controlled trials with larger sample sizes for evaluating SMS text messaging interventions aimed to support caregivers of children undergoing tonsillectomy surgery are warranted. %M 36125849 %R 10.2196/39617 %U https://periop.jmir.org/2022/1/e39617 %U https://doi.org/10.2196/39617 %U http://www.ncbi.nlm.nih.gov/pubmed/36125849 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e35514 %T Adapting the Eliminating Medications Through Patient Ownership of End Results Protocol to Promote Benzodiazepine Cessation Among US Military Veterans: Focus Group Study With US Military Veterans and National Veterans Health Administration Leaders %A Cucciare,Michael A %A Abraham,Traci H %A Kemp,Lakiesha %A White,Penny %A Marchant,Kathy %A Hagedorn,Hildi J %A Humphreys,Keith %+ Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Affairs Healthcare System, 2200 Fort Roots Drive, North Little Rock, AR, 72114, United States, 1 526 8179, MACucciare@uams.edu %K self-taper %K electronically delivered self-help %K long-term benzodiazepine use %K US military veterans %K mobile phone %D 2022 %7 19.9.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Long-term dependence on prescribed benzodiazepines is a public health problem. Eliminating Medications Through Patient Ownership of End Results (EMPOWER) is a promising self-management intervention, delivered directly to patients as a printed booklet, that is effective in promoting benzodiazepine reduction and cessation in older adults. EMPOWER has high potential to benefit large health care systems such as the US Veterans Health Administration (VHA), which cares for many veterans who use benzodiazepines for extended periods. Objective: We aimed to adapt the original EMPOWER booklet materials for electronic delivery and for use among US military veterans receiving VHA care who were long-term benzodiazepine users. Methods: We used elements of Analysis, Design, Development, Implementation, and Evaluation, a framework commonly used in the field of instructional design, to guide a qualitative approach to iteratively adapting EMPOWER Electronic Delivery (EMPOWER-ED). We conducted 3 waves of focus groups with the same 2 groups of VHA stakeholders. Stakeholders were VHA-enrolled veterans (n=16) with medical chart evidence of long-term benzodiazepine use and national VHA leaders (n=7) with expertise in setting VHA policy for prescription benzodiazepine use and developing electronically delivered educational tools for veterans. Qualitative data collected from each wave of focus groups were analyzed using template analysis. Results: Themes that emerged from the initial focus groups included veterans’ anxiety about self-tapering from benzodiazepines and prior negative experiences attempting to self-taper without support. Participants also provided feedback on the protocol’s look and feel, educational content, the tapering protocol, and website functionality; for example, feedback from policy leaders included listing, on the cover page, the most commonly prescribed benzodiazepines to ensure that veterans were aware of medications that qualify for self-taper using the EMPOWER-ED protocol. Both groups of stakeholders identified the importance of having access to supportive resources to help veterans manage sleep and anxiety in the absence of taking benzodiazepines. Both groups also emphasized the importance of ensuring that the self-taper could be personalized and that the taper instructions were clear. The policy leaders emphasized the importance of encouraging veterans to notify their provider of their decision to self-taper to help facilitate provider assistance, if needed, with the taper process and to help prevent medication stockpiling. Conclusions: EMPOWER-ED is the first direct-to-patient electronically delivered protocol designed to help US military veterans self-taper from long-term benzodiazepine use. We used the Analysis, Design, Development, Implementation, and Evaluation framework to guide the successful adaption of the original EMPOWER booklet for use with this population and for electronic delivery. The next step in this line of research is to evaluate EMPOWER-ED in a randomized controlled trial. %M 36121697 %R 10.2196/35514 %U https://www.jmir.org/2022/9/e35514 %U https://doi.org/10.2196/35514 %U http://www.ncbi.nlm.nih.gov/pubmed/36121697 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 9 %P e40703 %T Postoperative Outcomes of a Digital Rehabilitation Program After Total Knee Arthroplasty: Retrospective, Observational Feasibility Study %A Hong,Mindy %A Loeb,Joey %A Yang,Manshu %A Bailey,Jeannie F %+ Hinge Health, Inc., 455 Market Street, Suite 700, San Francisco, CA, 94105, United States, 1 615 498 8308, mindy.hong@hingehealth.com %K total knee arthroplasty %K surgical %K digital intervention %K musculoskeletal %K telemedicine %D 2022 %7 19.9.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Surgery can sometimes be the best solution for chronic musculoskeletal pain, but presurgical preparation and postsurgical rehabilitation are often required to achieve the maximum benefits. A digital musculoskeletal surgical care program was developed to support the population of patients undergoing total knee arthroplasty. Objective: We aimed to demonstrate safety, engagement, and acceptability and explore clinical outcomes, health care use, and satisfaction among participants of a digital musculoskeletal surgical care program who were undergoing total knee arthroplasty. Methods: A retrospective, observational feasibility study comparing digital musculoskeletal surgical care program participants to a comparison group was conducted. The intervention group registered for a digital musculoskeletal surgical care program, which included health coaches, physical therapists, and tailored exercises and educational articles to provide preoperative and postoperative support to patients who had recently undergone total knee arthroplasty. Comparison group members received standard-of-care treatment. Engagement (number of exercise therapy sessions and educational articles accessed per week) and acceptability (Net Promoter Score) were examined among intervention group participants. Descriptive statistics for postoperative outcomes, including safety (postoperative complications), clinical improvement (pain, function, anxiety, and depression), and health care use and experiences (length of hospital stay, surgery satisfaction, and physical therapy adherence), were reported for both groups. Differences among postoperative results were compared by using the independent samples 2-tailed t test or Mann-Whitney test for continuous outcomes and the Fisher exact test or chi-square test for categorical outcomes. Results: Of the 53 participants (intervention group: n=22; comparison group: n=31) who were included in this study, 35 (66%) were female and 25 (47%) were aged from 45 to 60 years. On average, the intervention group completed 23 exercise sessions, read 2.7 educational articles, sent 45.5 texts to their health coaches, and were actively engaged for 6 weeks after their operation. Among 21 participants, 14 (67%) self-reported as promoters on the Net Promoter Score scale. Intervention group members reported fewer postoperative complications (6/22, 27%) than the comparison group (15/31, 48%), and they experienced better outcomes with regard to function (Knee Injury and Osteoarthritis Outcome Score–Physical Function Short Form—intervention group: mean 23.0; comparison group: mean 32.5), depression (Patient Health Questionnaire 2-Item—intervention group: mean 0.4; comparison group: mean 1.6), anxiety (General Anxiety Disorder 2-Item—intervention group: mean 0.6; comparison group: mean 1.5), and impressions of change (Patient Global Impression of Change—intervention group: median 7.0; comparison group: median 6.0). Intervention group participants also reported less health care use, better adherence to their physical therapy exercises, and higher surgery satisfaction. Conclusions: Our digital musculoskeletal surgical care program shows promising levels of engagement and acceptability among those who recently underwent total knee arthroplasty. The surgical care program may also help with improving postsurgical complications and clinical outcomes and lowering health care use. %M 36121690 %R 10.2196/40703 %U https://formative.jmir.org/2022/9/e40703 %U https://doi.org/10.2196/40703 %U http://www.ncbi.nlm.nih.gov/pubmed/36121690 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 9 %P e36805 %T Influence of 2 Digital Exercise Modules of a Multimodular System on Balance and Leg Strength Under Consideration of Use Adherence: Prospective Cohort Study %A Venek,Verena %A Kranzinger,Christina %A Jungreitmayr,Sonja %A Ring-Dimitriou,Susanne %A Schwameder,Hermann %A Stöggl,Thomas %+ Salzburg Research Forschungsgesellschaft mbH, Jakob Haringer Straße 5/3, Salzburg, 5020, Austria, 43 6622288 ext 415, v.venek@fh-kaernten.at %K active and assisted living %K functional fitness training %K information and communication technology %K use adherence %D 2022 %7 19.9.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: To empower healthy aging, digital solutions embed multiple modules for physical activity, cognitive health promotion, and social engagement. Integrating new empowering technologies such as digital exercise monitoring requires assessment measures and analysis procedures, considering variable compliance of users with different modules. Objective: This study aims to assess the influence of a tablet-based and a feedback system–based exercise module on balance and leg strength by considering use adherence instead of the use of the entire multimodular system. Methods: In the prospective cohort study within the fit4AAL project, 83 users (n=67, 81% women; n=16, 19% men; mean age 66.2, SD 2.3 years) used the 2 digital exercise modules of a multimodular physical activity promotion system for >18 weeks. A data-driven clustering method based on the average use frequency of the exercise modules determined the number of user types that met the World Health Organization–recommended training frequency of at least twice per week. On the basis of this use adherence, statistical analysis was performed with features of functional performance tests (unipedal stance, 30-second chair rise, Y-balance, and hurdle step tests). The tests were conducted 6 months before the intervention, immediately before the intervention, and after the intervention, comparing the baseline phase with the 3 feedback use groups of the study (using only the tablet, the tablet and the feedback system, or only the feedback system). Results: Of the 83 users, 43 (52%) met the World Health Organization–recommended frequency of muscle-strengthening activities. Overall, the feedback use groups achieved, on average, more chair rises in 30 seconds than the baseline group (P=.01; moderate effect size of 0.07). Of the 43 users, 26 (60%) additionally used the feedback system–based exercise module. They improved in balance compared with the users using either the tablet or the feedback system (P=.02). In addition, they improved their leg strength within the group (P=.04) and compared with the baseline (P=.01). Conclusions: The additional use of a feedback system showed a tendency to positively maintain and influence the already exceptionally high functional performance of older adults. Considering use adherence in future multimodular system studies is crucial to assess the influence of single and combined use of exercise modules on functional performance. %M 36121691 %R 10.2196/36805 %U https://formative.jmir.org/2022/9/e36805 %U https://doi.org/10.2196/36805 %U http://www.ncbi.nlm.nih.gov/pubmed/36121691 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 9 %P e36517 %T Acceptability and Impact of an Educational App (iCare) for Informal Carers Looking After People at Risk of Pressure Ulceration: Mixed Methods Pilot Study %A McKeown,Eamonn %A McGraw,Caroline %A Holder,Pru %A Shand,Jenny %A Hirani,Shashivadan P %+ School of Health & Psychological Sciences, City, University of London, Northampton Square, London, EC1V 0HB, United Kingdom, 44 70405917, eamonn.mckeown.1@city.ac.uk %K pressure ulcers %K informal carers %K smartphone apps %K mobile health %K mHealth %K educational technology %K health education %K mobile phone %D 2022 %7 16.9.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Pressure ulcers are areas of skin damage resulting from sustained pressure. Informal carers play a central role in preventing pressure ulcers among older and disabled people living at home. Studies highlight the paucity of pressure ulcer training for informal carers and suggest that pressure ulcer risk is linked to high levels of carer burden. Objective: This pilot study evaluated a smartphone app with a specific focus on pressure ulcer prevention education for informal carers. The app was developed based on the principles of microlearning. The study aimed to explore carer perspectives on the acceptability of the app and determine whether the app increased knowledge and confidence in their caring role. Methods: In this concurrent mixed methods study, participants completed quantitative questionnaires at baseline and at the end of weeks 2 and 6, which examined caregiving self-efficacy, preparedness for caregiving, caregiver strain, pressure ulcer knowledge, and app acceptability and usability. A subsample of participants participated in a “think aloud” interview in week 1 and semistructured interviews at the end of weeks 2 and 6. Results: Of the 32 participants, 23 (72%) participants completed the week 2 and 16 (50%) completed the week 6 questionnaires; 66% (21/32) of carers participated in qualitative “think aloud” interviews, and 18 (56%) also participated in semistructured interviews at week 2, and 13 (41%) at week 6. Pressure ulcer knowledge scores significantly changed (F1,6.112=21.624; P=.001) from baseline (mean 37.5; SE 2.926) to the second follow-up (mean 59.72, SE 3.985). Regarding the qualitative data, the theme “I’m more careful now and would react to signs of redness” captured participants’ reflections on the new knowledge they had acquired, the changes they had made to their caring routines, their increased vigilance for signs of skin damage, and their intentions toward the app going forward. There were no significant results pertaining to improved preparedness for caregiving or caregiving self-efficacy or related to the Caregiver Strain Index. Participants reported above average usability scores on a scale of 0 to 100 (mean 69.94, SD 18.108). The app functionality and information quality were also rated relatively high on a scale of 0 to 5 (mean 3.84, SD 0.704 and mean 4.13, SD 0.452, respectively). Overall, 2 themes pertaining to acceptability and usability were identified: “When you’re not used to these things, they take time to get the hang of” and “It’s not a fun app but it is informative.” All participants (n=32, 100%) liked the microlearning approach. Conclusions: The iCare app offers a promising way to improve informal carers’ pressure ulcer knowledge. However, to better support carers, the findings may reflect the need for future iterations of the app to use more interactive elements and the introduction of gamification and customization based on user preferences. %M 36112413 %R 10.2196/36517 %U https://formative.jmir.org/2022/9/e36517 %U https://doi.org/10.2196/36517 %U http://www.ncbi.nlm.nih.gov/pubmed/36112413 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 3 %P e35486 %T Participants’ and Nurses’ Experiences With a Digital Intervention for Patients With Depressive Symptoms and Comorbid Hypertension or Diabetes in Peru: Qualitative Post–Randomized Controlled Trial Study %A Toyama,Mauricio %A Cavero,Victoria %A Araya,Ricardo %A Menezes,Paulo Rossi %A Mohr,David C %A Miranda,J Jaime %A Diez-Canseco,Francisco %+ CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Av. Armendariz 445, Miraflores, Lima, 15074, Peru, 51 958549065, m.toyama.g@gmail.com %K mobile intervention %K depression %K diabetes %K hypertension %K comorbidity %K qualitative research %K mobile phone %D 2022 %7 15.9.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Depression is one of the most prevalent mental disorders and a leading cause of disability, disproportionately affecting specific groups, such as patients with noncommunicable diseases. Over the past decade, digital interventions have been developed to provide treatment for these patients. CONEMO (Emotional Control in Spanish) is an 18-session psychoeducational digital intervention delivered through a smartphone app and minimally supported by a nurse. CONEMO demonstrated effectiveness in reducing depressive symptoms through a randomized controlled trial (RCT) among patients with diabetes, hypertension, or both, in Lima, Peru. However, in addition to clinical outcomes, it is important to explore users’ experiences, satisfaction, and perceptions of usability and acceptability, which can affect their engagement with the intervention. Objective: This study aimed to explore the RCT participants’ experiences with CONEMO in Peru, complemented with information provided by the nurses who monitored them. Methods: In 2018, semistructured interviews were conducted with a sample of 29 (13.4%) patients from the 217 patients who participated in the CONEMO intervention in Peru and the 3 hired nurses who supported its delivery. Interviewees were selected at random based on their adherence to the digital intervention (0-5, 10-14, and 15-18 sessions completed), to include different points of view. Content analysis was conducted to analyze the interviews. Results: Participants’ mean age was 64.4 (SD 8.5) years, and 79% (23/29) of them were women. Most of the interviewed participants (21/29, 72%) stated that CONEMO fulfilled their expectations and identified positive changes in their physical and mental health after using it. Some of these improvements were related to their thoughts and feelings (eg, think differently, be more optimistic, and feel calmer), whereas others were related to their routines (eg, go out more and improve health-related habits). Most participants (19/29, 66%) reported not having previous experience with using smartphones, and despite experiencing some initial difficulties, they managed to use CONEMO. The most valued features of the app were the videos and activities proposed for the participant to perform. Most participants (27/29, 93%) had a good opinion about the study nurses and reported feeling supported by them. A few participants provided suggestions to improve the intervention, which included adding more videos, making the sessions’ text simple, extending the length of the intervention, and improving the training session with long explanations. Conclusions: The findings of this qualitative study provide further support and contextualize the positive results found in the CONEMO RCT, including insights into the key features that made the intervention effective and engaging. The participants’ experience with the smartphone and CONEMO app reveal that it is feasible to be used by people with little knowledge of technology. In addition, the study identified suggestions to improve the CONEMO intervention for its future scale-up. Trial Registration: ClinicalTrials.gov NCT03026426; https://clinicaltrials.gov/ct2/show/NCT03026426 %M 36107482 %R 10.2196/35486 %U https://humanfactors.jmir.org/2022/3/e35486 %U https://doi.org/10.2196/35486 %U http://www.ncbi.nlm.nih.gov/pubmed/36107482 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e36978 %T Comparability of Patients in Trials of eHealth and Face-to-Face Psychotherapeutic Interventions for Depression: Meta-synthesis %A Aemissegger,Vera %A Lopez-Alcalde,Jesus %A Witt,Claudia M %A Barth,Jürgen %+ Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Sonneggstrasse 6, Zurich, 8091, Switzerland, 41 44 255 48 96, mail@juergen-barth.de %K depression %K mental health %K digital intervention %K eHealth %K web-based %K randomized controlled trial %K RCT %K meta-analysis %K epidemiology %K epidemiological %K depressive disorder %K mental illness %K mental condition %K mental disorder %K psychotherapy %K psychotherapeutic intervention %K CBT %K iCBT %K cognitive behavioral therapy %K face-to-face %K cognitive therapy %K interpersonal therapy %D 2022 %7 14.9.2022 %9 Review %J J Med Internet Res %G English %X Background: Depressive disorders (DDs) are a public health problem. Face-to-face psychotherapeutic interventions are a first-line option for their treatment in adults. There is a growing interest in eHealth interventions to maximize accessibility for effective treatments. Thus, the number of randomized controlled trials (RCTs) of eHealth psychotherapeutic interventions has increased, and these interventions are being offered to patients. However, it is unknown whether patients with DDs differ in internet-based and face-to-face intervention trials. This information is essential to gain knowledge about eHealth trials’ external validity. Objective: We aimed to compare the baseline characteristics of patients with DDs included in the RCTs of eHealth and face-to-face psychotherapeutic interventions with a cognitive component. Methods: In this meta-epidemiological study, we searched 5 databases between 1990 and November 2017 (MEDLINE, Embase, PsycINFO, Google Scholar, and the database of Cuijpers et al). We included RCTs of psychotherapeutic interventions with a cognitive component (eg, cognitive therapy, cognitive behavioral therapy [CBT], or interpersonal therapy) delivered face-to-face or via the internet to adults with DDs. Each included study had a matching study for predefined criteria to allow a valid comparison of characteristics and was classified as a face-to-face (CBT) or eHealth (internet CBT) intervention trial. Two authors selected the studies, extracted data, and resolved disagreements by discussion. We tested whether predefined baseline characteristics differed in face-to-face and internet-based trials using a mixed-effects model and testing for differences with z tests (statistical significance set at .05). For continuous outcomes, we also estimated the difference in means between subgroups with 95% CI. Results: We included 58 RCTs (29 matching pairs) with 3846 participants (female: n=2803, 72.9%) and mean ages ranging from 20-74 years. White participants were the most frequent (from 63.6% to 100%). Other socioeconomic characteristics were poorly described. The participants presented DDs of different severity measured with heterogeneous instruments. Internet CBT trials had a longer depression duration at baseline (7.19 years higher, CI 95% 2.53-11.84; 10.0 vs 2.8 years; P=.002), but the proportion of patients with previous depression treatment was lower (24.8% vs 42%; P=.04). Subgroup analyses found no evidence of differences for the remaining baseline characteristics: age, gender, education, living area, depression severity, history of depression, actual antidepressant medication, actual physical comorbidity, actual mental comorbidity, study dropout, quality of life, having children, family status, and employment. We could not compare proficiency with computers due to the insufficient number of studies. Conclusions: The baseline characteristics of patients with DDs included in the RCTs of eHealth and face-to-face psychotherapeutic interventions are generally similar. However, patients in eHealth trials had a longer duration of depression, and a lower proportion had received previous depression treatment, which might indicate that eHealth trials attract patients who postpone earlier treatment attempts. Trial Registration: PROSPERO CRD42019085880; https://tinyurl.com/4xufwcyr %M 36103217 %R 10.2196/36978 %U https://www.jmir.org/2022/9/e36978 %U https://doi.org/10.2196/36978 %U http://www.ncbi.nlm.nih.gov/pubmed/36103217 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 9 %P e40739 %T Agreement Between Clinically Measured Weight and Self-reported Weight Among Patients With Type 2 Diabetes Through an mHealth Lifestyle Coaching Program in Denmark: Secondary Analysis of a Randomized Controlled Trial %A Imeraj,Albi %A Olesen,Thomas Bastholm %A Laursen,Ditte Hjorth %A Søndergaard,Jens %A Brandt,Carl Joakim %+ Research Unit for General Practice, Department of Public Health, University of Southern Denmark, J B Winsløws Vej 9A, Odense, 5000, Denmark, 45 31390187, aimeraj@health.sdu.dk %K telemedicine %K digital behavioral coaching %K lifestyle change %K mobile intervention %K obesity %K diabetes %K patient engagement %K validation %K self-report %K body weight %D 2022 %7 14.9.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital health interventions are increasingly used to handle and promote positive health behaviors. Clinical measures are often used, and a certain precision is essential for digital health interventions to have an effect. Only few studies have compared clinically measured weights with self-reported weights. No study has examined the validity of self-reported weight from a mobile app used in a tailored weight loss intervention. Objective: The aim of this study was to analyze the agreement between clinically measured weight and self-reported weight collected from a mobile health lifestyle coaching program during a 12-month weight loss intervention for obese patients with and without type 2 diabetes. The secondary aim was to investigate the determinants for possible discrepancies between clinically measured and self-reported weights of these patients with different demographic and lifestyle characteristics and achievements of weight loss goals. Methods: Weight registrations were collected from participants (N=104) in a Danish randomized controlled trial examining the effect of a digital lifestyle intervention on weight loss among obese patients with and without type 2 diabetes. Data were collected at baseline and after 6 and 12 months. Self-reported weight was measured at home and registered in the app. Results: Self-reported body weight was lower than the weight measured in the clinic after 6 months by 1.03 kg (95% CI 1.01-1.05; P<.001) and after 12 months also by 1.03 kg (95% CI 0.99-1.04; P<.001). After 6 months, baseline weight and BMI were associated with a discrepancy of 0.03 kg (95% CI 0.01-0.04; P=.01) and 0.09 kg (95% CI 0.02-0.17; P=.02) per increment of 1 kg and 1 kg/m2, respectively, between clinically measured weight and self-reported weight. Weight change during the first 6 months was also associated with a difference of 0.1 kg (95% CI 0.04-0.01; P<.001) per kilogram of difference in weight between clinically measured weight and self-reported weight. Participants who did not achieve the 5% weight loss goal underestimated their weight by 0.79 kg (95% CI 0.34-1.23) at 6 months. After 12 months, only baseline weight was associated with a discrepancy of 0.03 kg (95% CI 0.01-0.05; P=.02) per increment of kilogram between clinically measured weight and self-reported weight. None of the other factors showed any significant discrepancy after 12 months. Conclusions: Self-reported weight obtained from mobile health is a valid method for collecting anthropometric measurements. Trial Registration: ClinicalTrials.gov NCT03788915; https://clinicaltrials.gov/ct2/show/NCT03788915 %M 36047606 %R 10.2196/40739 %U https://formative.jmir.org/2022/9/e40739 %U https://doi.org/10.2196/40739 %U http://www.ncbi.nlm.nih.gov/pubmed/36047606 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e38541 %T Evaluating the Effectiveness of Internet-Based Communication for Public Health: Systematic Review %A Ceretti,Elisabetta %A Covolo,Loredana %A Cappellini,Francesca %A Nanni,Alberto %A Sorosina,Sara %A Beatini,Andrea %A Taranto,Mirella %A Gasparini,Arianna %A De Castro,Paola %A Brusaferro,Silvio %A Gelatti,Umberto %+ Section of Public Health and Human Sciences, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Viale Europa 11, Brescia, 25123, Italy, 39 3381617907, francesca.cappellini@unibs.it %K internet-based communication %K websites %K social media %K public health %K efficacy %K systematic review %K communication %K internet-based %K health information %K exchange %K health care %K web-based %K campaigns %D 2022 %7 13.9.2022 %9 Review %J J Med Internet Res %G English %X Background: Communicating strategically is a key issue for health organizations. Over the past decade, health care communication via social media and websites has generated a great deal of studies examining different realities of communication strategies. However, when it comes to systematic reviews, there is fragmentary evidence on this type of communication. Objective: The aim of this systematic review was to summarize the evidence on web institutional health communication for public health authorities to evaluate possible aim-specific key points based on these existing studies. Methods: Guided by the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement, we conducted a comprehensive review across 2 electronic databases (PubMed and Web of Science) from January 1, 2011, to October 7, 2021, searching for studies investigating institutional health communication. In total, 2 independent researchers (AN and SS) reviewed the articles for inclusion, and the assessment of methodological quality was based on the Kmet appraisal checklist. Results: A total of 78 articles were selected. Most studies (35/78, 45%) targeted health promotion and disease prevention, followed by crisis communication (24/78, 31%), general health (13/78, 17%), and misinformation correction and health promotion (6/78, 8%). Engagement and message framing were the most analyzed aspects. Few studies (14/78, 18%) focused on campaign effectiveness. Only 23% (18/78) of the studies had an experimental design. The Kmet evaluation was used to distinguish studies presenting a solid structure from lacking studies. In particular, considering the 0.75-point threshold, 36% (28/78) of the studies were excluded. Studies above this threshold were used to identify a series of aim-specific and medium-specific suggestions as the communication strategies used differed greatly. Conclusions: Overall, the findings suggest that no single strategy works best in the case of web-based health care communication. The extreme variability of outcomes and the lack of a unitary measure for assessing the end points of a specific campaign or study lead us to reconsider the tools we use to evaluate the efficacy of web-based health communication. %M 36098994 %R 10.2196/38541 %U https://www.jmir.org/2022/9/e38541 %U https://doi.org/10.2196/38541 %U http://www.ncbi.nlm.nih.gov/pubmed/36098994 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 9 %P e37287 %T Motive-Oriented, Personalized, Internet-Based Interventions for Depression: Nonclinical Experimental Study %A Bücker,Lara %A Berger,Thomas %A Bruhns,Alina %A Westermann,Stefan %+ Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, Hamburg, 20246, Germany, 49 040 7410 55868, l.buecker@uke.de %K internet-based interventions %K depression %K adherence %K motive orientation %K personalization %D 2022 %7 13.9.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The low level of adherence in internet-based self-help interventions for depression suggests that in many existing programs, the motivational fit between the program and the user is unsatisfactory (eg, the user seeks autonomy, but the program provides directive guidance). Personalized, motive-oriented, self-help interventions could enable participants who interact with a program and its contents to have more engaging and less aversive experiences and thus increase adherence. Objective: In an experimental study with a nonclinical analogue sample, we aimed to test the hypotheses that a better motivational person-program fit is linked with higher anticipated adherence, working alliance, and satisfaction with the program. Methods: Motivational person-program fit was examined with respect to the 2 contrasting motives being autonomous and being supported. The hypotheses were tested by specifically varying the motivational person-program fit in a nonclinical sample (N=55), where participants were asked to work on, and subsequently evaluate, a limited set of individual pages of a self-help program with guidance (in the form of text messages) for depression. The sections of the self-help program were redesigned to either particularly address the autonomy motive or the support motive. For the quasi-experimental variation of the motivational person-program characteristics, we divided the 55 participants into 2 groups (autonomy group: n=27, 49%; support group: n=28, 51%) by screening method (using the Inventory of Approach and Avoidance Motivation), corresponding to the 2 motives. Both groups evaluated (in randomized order) 2 excerpts of the program—one that matched their motive (fit) and one that was contrary to it (no fit). Immediately after the evaluation of each excerpt, anticipated adherence, working alliance, and treatment satisfaction were assessed. Results: Regarding being supported, the satisfaction with or violation of this motive had an impact on (optimal) anticipated adherence as well as working alliance and satisfaction with the intervention; a congruent person-program fit resulted in significantly higher anticipated adherence (t27=3.00; P=.006), working alliance (t27=3.20; P=.003), and satisfaction (t27=2.86; P=.008) than a noncongruent fit. However, a similar impact could not be found for the motive being autonomous. Several correlations were found that supported our hypotheses (eg, for the congruent person-program fit autonomy motive and autonomy group, support satisfaction negatively correlated with optimal anticipated adherence). Conclusions: This first experimental study gives reason to assume that motive orientation may have a positive influence on adherence, working alliance, and satisfaction in internet-based self-help interventions for depression and other mental disorders. Future studies should conduct randomized controlled trials with clinical samples and assess clinical outcomes. %M 36098989 %R 10.2196/37287 %U https://formative.jmir.org/2022/9/e37287 %U https://doi.org/10.2196/37287 %U http://www.ncbi.nlm.nih.gov/pubmed/36098989 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e35620 %T Web-Based Mindfulness-Based Interventions for Well-being: Randomized Comparative Effectiveness Trial %A Sylvia,Louisa G %A Lunn,Mitchell R %A Obedin-Maliver,Juno %A McBurney,Robert N %A Nowell,W Benjamin %A Nosheny,Rachel L %A Mularski,Richard A %A Long,Millie D %A Merkel,Peter A %A Pletcher,Mark J %A Tovey,Roberta E %A Scalchunes,Christopher %A Sutphen,Rebecca %A Martin,Ann S %A Horn,Elizabeth J %A O'Boyle,Megan %A Pitch,Lisa %A Seid,Michael %A Redline,Susan %A Greenebaum,Sophie %A George,Nevita %A French,Noah J %A Faria,Caylin M %A Puvanich,Nicha %A Rabideau,Dustin J %A Selvaggi,Caitlin A %A Yu,Chu %A Faraone,Stephen V %A Venkatachalam,Shilpa %A McCall,Debbe %A Terry,Sharon F %A Deckersbach,Thilo %A Nierenberg,Andrew A %+ Department of Psychiatry, Massachusetts General Hospital, 50 Staniford Street, Suite 580, Boston, MA, 02114, United States, 1 617 643 4804, lsylvia2@mgh.harvard.edu %K mindfulness %K well-being %K web %K control trial %K clinical trial %K cognitive therapy %K intervention %K mental health %K mindful %K eHealth %K mobile phone %D 2022 %7 12.9.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Mindfulness can improve overall well-being by training individuals to focus on the present moment without judging their thoughts. However, it is unknown how much mindfulness practice and training are necessary to improve well-being. Objective: The primary aim of this study was to determine whether a standard 8-session web-based mindfulness-based cognitive therapy (MBCT) program, compared with a brief 3-session mindfulness intervention, improved overall participant well-being. In addition, we sought to explore whether the treatment effects differed based on the baseline characteristics of the participants (ie, moderators). Methods: Participants were recruited from 17 patient-powered research networks, web-based communities of stakeholders interested in a common research area. Participants were randomized to either a standard 8-session MBCT or a brief 3-session mindfulness training intervention accessed on the web. The participants were followed for 12 weeks. The primary outcome of the study was well-being, as measured by the World Health Organization—Five Well-Being Index. We hypothesized that MBCT would be superior to a brief mindfulness training. Results: We randomized 4411 participants, 3873 (87.80%) of whom were White and 3547 (80.41%) of female sex assigned at birth. The mean baseline World Health Organization—Five Well-Being Index score was 50.3 (SD 20.7). The average self-reported well-being in each group increased over the intervention period (baseline to 8 weeks; model-based slope for the MBCT group: 0.78, 95% CI 0.63-0.93, and brief mindfulness group: 0.76, 95% CI 0.60-0.91) as well as the full study period (ie, intervention plus follow-up; baseline to 20 weeks; model-based slope for MBCT group: 0.41, 95% CI 0.34-0.48; and brief mindfulness group: 0.33, 95% CI 0.26-0.40). Changes in self-reported well-being were not significantly different between MBCT and brief mindfulness during the intervention period (model-based difference in slopes: −0.02, 95% CI −0.24 to 0.19; P=.80) or during the intervention period plus 12-week follow-up (−0.08, 95% CI −0.18 to 0.02; P=.10). During the intervention period, younger participants (P=.05) and participants who completed a higher percentage of intervention sessions (P=.005) experienced greater improvements in well-being across both interventions, with effects that were stronger for participants in the MBCT condition. Attrition was high (ie, 2142/4411, 48.56%), which is an important limitation of this study. Conclusions: Standard MBCT improved well-being but was not superior to a brief mindfulness intervention. This finding suggests that shorter mindfulness programs could yield important benefits across the general population of individuals with various medical conditions. Younger people and participants who completed more intervention sessions reported greater improvements in well-being, an effect that was more pronounced for participants in the MBCT condition. This finding suggests that standard MBCT may be a better choice for younger people as well as treatment-adherent individuals. Trial Registration: ClinicalTrials.gov NCT03844321; https://clinicaltrials.gov/ct2/show/NCT03844321 %M 36094813 %R 10.2196/35620 %U https://www.jmir.org/2022/9/e35620 %U https://doi.org/10.2196/35620 %U http://www.ncbi.nlm.nih.gov/pubmed/36094813 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e39910 %T Enrollment and Retention of Participants in Remote Digital Health Studies: Scoping Review and Framework Proposal %A Daniore,Paola %A Nittas,Vasileios %A von Wyl,Viktor %+ Institute for Implementation Science in Healthcare, University of Zurich, Universitatstrasse 84, Zurich, 8006, Switzerland, 41 0446343762, viktor.vonwyl@uzh.ch %K remote digital health studies %K remote clinical trials %K remote cohorts %K digital epidemiology %K digital health %K health outcome %K conceptual framework %K user-centered design %K population-based digital health %K participant recruitment %K interventional study %D 2022 %7 9.9.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital technologies are increasingly used in health research to collect real-world data from wider populations. A new wave of digital health studies relies primarily on digital technologies to conduct research entirely remotely. Remote digital health studies hold promise to significant cost and time advantages over traditional, in-person studies. However, such studies have been reported to typically suffer from participant attrition, the sources for which are still largely understudied. Objective: To contribute to future remote digital health study planning, we present a conceptual framework and hypotheses for study enrollment and completion. The framework introduces 3 participation criteria that impact remote digital health study outcomes: (1) participant motivation profile and incentives or nudges, (2) participant task complexity, and (3) scientific requirements. The goal of this study is to inform the planning and implementation of remote digital health studies from a person-centered perspective. Methods: We conducted a scoping review to collect information on participation in remote digital health studies, focusing on methodological aspects that impact participant enrollment and retention. Comprehensive searches were conducted on the PubMed, CINAHL, and Web of Science databases, and additional sources were included in our study from citation searching. We included digital health studies that were fully conducted remotely, included information on at least one of the framework criteria during recruitment, onboarding or retention phases of the studies, and included study enrollment or completion outcomes. Qualitative analyses were performed to synthesize the findings from the included studies. Results: We report qualitative findings from 37 included studies that reveal high values of achieved median participant enrollment based on target sample size calculations, 128% (IQR 100%-234%), and median study completion, 48% (IQR 35%-76%). Increased median study completion is observed for studies that provided incentives or nudges to extrinsically motivated participants (62%, IQR 43%-78%). Reducing task complexity for participants in the absence of incentives or nudges did not improve median study enrollment (103%, IQR 102%-370%) or completion (43%, IQR 22%-60%) in observational studies, in comparison to interventional studies that provided more incentives or nudges (median study completion rate of 55%, IQR 38%-79%). Furthermore, there were inconsistencies in measures of completion across the assessed remote digital health studies, where only around half of the studies with completion measures (14/27, 52%) were based on participant retention throughout the study period. Conclusions: Few studies reported on participatory factors and study outcomes in a consistent manner, which may have limited the evidence base for our study. Our assessment may also have suffered from publication bias or unrepresentative study samples due to an observed preference for participants with digital literacy skills in digital health studies. Nevertheless, we find that future remote digital health study planning can benefit from targeting specific participant profiles, providing incentives and nudges, and reducing study complexity to improve study outcomes. %M 36083626 %R 10.2196/39910 %U https://www.jmir.org/2022/9/e39910 %U https://doi.org/10.2196/39910 %U http://www.ncbi.nlm.nih.gov/pubmed/36083626 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 9 %P e36662 %T Content and Effectiveness of Web-Based Treatments for Online Behavioral Addictions: Systematic Review %A Park,Jennifer J %A King,Daniel L %A Wilkinson-Meyers,Laura %A Rodda,Simone N %+ School of Population Health, The University of Auckland, Building 507, 22-30 Park Ave, Grafton, Auckland, 1023, New Zealand, 64 210 822 6685, jpar956@aucklanduni.ac.nz %K systematic review %K gambling %K gaming %K internet intervention %K pornography %K treatment %K social media %D 2022 %7 9.9.2022 %9 Review %J JMIR Ment Health %G English %X Background: Very few people seek in-person treatment for online behavioral addictions including gaming and gambling or problems associated with shopping, pornography use, or social media use. Web-based treatments have the potential to address low rates of help seeking due to their convenience, accessibility, and capacity to address barriers to health care access (eg, shame, stigma, cost, and access to expert care). However, web-based treatments for online behavioral addictions have not been systematically evaluated. Objective: This review aimed to systematically describe the content of web-based treatments for online behavioral addictions and describe their therapeutic effectiveness on symptom severity and consumption behavior. Methods: A database search of MEDLINE, Embase, PsycInfo, Web of Science, Cochrane Central Register of Controlled Trials, and Google Scholar was conducted in June 2022. Studies were eligible if the study design was a randomized controlled trial or a pre-post study with at least 1 web-based intervention arm for an online behavioral addiction and if the study included the use of a validated measure of problem severity, frequency, or duration of online behavior. Data on change techniques were collected to analyze intervention content, using the Gambling Intervention System of CharacTerization. Quality assessment was conducted using the Effective Public Health Practice Project Quality Assessment Tool. Results: The review included 12 studies with 15 intervention arms, comprising 7 randomized controlled trials and 5 pre-post studies. The primary focus of interventions was gaming (n=4), followed by internet use inclusive of screen time and smartphone use (n=3), gambling (n=3), and pornography (n=2). A range of different technologies were used to deliver content, including websites (n=6), email (n=2), computer software (n=2), social media messaging (n=1), smartphone app (n=1), virtual reality (n=1), and videoconferencing (n=1). Interventions contained 15 different change techniques with an average of 4 per study. The techniques most frequently administered (>30% of intervention arms) were cognitive restructuring, relapse prevention, motivational enhancement, goal setting, and social support. Assessment of study quality indicated that 7 studies met the criteria for moderate or strong global ratings, but only 8 out of 12 studies evaluated change immediately following the treatment. Across included studies, two-thirds of participants completed after-treatment evaluation, and one-quarter completed follow-up evaluation. After-intervention evaluation indicated reduced severity (5/9, 56%), frequency (2/3, 67%), and duration (3/7, 43%). Follow-up evaluation indicated that 3 pre-post studies for gaming, gambling, and internet use demonstrated reduced severity, frequency, and duration of consumption. At 3-month evaluation, just 1 pre-post study indicated significant change to mental health symptoms. Conclusions: Web-based treatments for online behavioral addictions use an array of mechanisms to deliver cognitive and behavioral change techniques. Web-based treatments demonstrate promise for short-term reduction in symptoms, duration, or frequency of online addictive behaviors. However, there is limited evidence on the effectiveness of web-based treatments over the longer term due to the absence of controlled trials. %M 36083612 %R 10.2196/36662 %U https://mental.jmir.org/2022/9/e36662 %U https://doi.org/10.2196/36662 %U http://www.ncbi.nlm.nih.gov/pubmed/36083612 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e40637 %T Internet-Delivered Cognitive Behavioral Therapy for Postsecondary Students: Randomized Factorial Trial for Examining Motivational Interviewing and Booster Lessons %A Peynenburg,Vanessa %A Hadjistavropoulos,Heather %A Thiessen,David %A Titov,Nickolai %A Dear,Blake %+ Department of Psychology, University of Regina, 3737 Wascana Parkway Drive, Regina, SK, S4S 0A2, Canada, 1 306 585 5133, hadjista@uregina.ca %K postsecondary students %K transdiagnostic %K boosters %K motivational interviewing %K internet-delivered cognitive behavioral therapy %D 2022 %7 7.9.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-delivered cognitive behavioral therapy (ICBT) can improve access to mental health care for students, although high attrition rates are concerning and little is known about long-term outcomes. Motivational interviewing (MI) exercises and booster lessons can improve engagement and outcomes in face-to-face cognitive behavioral therapy. Objective: This study aimed to examine the use of pretreatment MI exercises and booster lessons in ICBT for postsecondary students. Methods: In this factorial trial (factor 1: web-based MI before treatment; factor 2: self-guided booster lesson 1 month after treatment), 308 clients were randomized to 1 of 4 treatment conditions, with 277 (89.9%) clients starting treatment. All clients received a 5-week transdiagnostic ICBT course (the UniWellbeing course). Primary outcomes included changes in depression, anxiety, and perceived academic functioning from before treatment to after treatment and at the 1-month and 3-month follow-ups. Results: Overall, 54% (150/277) of students completed treatment and reported large improvements in symptoms of depression and anxiety and small improvements in academic functioning after treatment, which were maintained at the 1-month and 3-month follow-ups. Pretreatment MI did not contribute to better treatment completion or engagement, although small between-group effects favored MI for reductions in depression (Cohen d=0.23) and anxiety (Cohen d=0.25) after treatment. Only 30.9% (43/139) of students randomized to one of the booster conditions accessed the booster. Overall, no main effects were found for the booster. Subanalyses revealed that clients who accessed the booster had larger decreases in depressive symptoms (Cohen d=0.31) at the 3-month follow-up. No interactions were found between MI and the booster. Conclusions: Rather than offering MI before treatment, clients may experience more benefits from MI exercises later in ICBT when motivation wanes. The low uptake of the self-guided booster limited our conclusions regarding its effectiveness. Future research should examine offering a booster for a longer duration after treatment, with therapist support and a longer follow-up period. Trial Registration: ClinicalTrials.gov NCT04264585; https://clinicaltrials.gov/ct2/show/NCT04264585 %M 36069785 %R 10.2196/40637 %U https://www.jmir.org/2022/9/e40637 %U https://doi.org/10.2196/40637 %U http://www.ncbi.nlm.nih.gov/pubmed/36069785 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e37563 %T Psychosocial Mediators of Web-Based Interventions for Promoting a Healthy Lifestyle Among Chinese College Students: Secondary Analysis of a Randomized Controlled Trial %A Liang,Wei %A Duan,Yanping %A Wang,Yanping %A Lippke,Sonia %A Shang,Borui %A Lin,Zhihua %A Wulff,Hagen %A Baker,Julien Steven %+ Department of Sport, Physical Education and Health, Faculty of Social Sciences, Hong Kong Baptist University, 12/F, Shek Mun Campus, 8 On Muk Street, Shek Mun, Shatin, Hong Kong, China (Hong Kong), 852 34113038, duanyp@hkbu.edu.hk %K web-based intervention %K physical activity %K fruit and vegetable consumption %K college students %K psychosocial mediators %K lifestyle %K randomized controlled trial %K RCT %K mobile phone %D 2022 %7 7.9.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based multiple health behavior change (MHBC) interventions have demonstrated effectiveness in promoting physical activity (PA) and fruit and vegetable consumption (FVC) among Chinese college students. However, there is limited research examining their effects on promoting a healthy lifestyle (ie, adhering to both PA and FVC behavioral recommendations) among Chinese college students. In addition, the salient psychosocial mediators of successful MHBC interventions need to be researched. Objective: This study aims to examine the effectiveness of a previous 8-week web-based MHBC program for promoting a healthy lifestyle and enhancing the psychosocial determinants (intention, self-efficacy, planning, and social support) of behavior change among Chinese college students. Furthermore, the study aims to identify whether changes in these psychosocial determinants mediate intervention effectiveness on the immediate and sustained lifestyle changes. Methods: This was a secondary analysis for a 3-arm randomized controlled trial. Chinese college students (N=552) were randomly assigned to 1 of 3 groups: a PA-first group (4-week PA intervention followed by 4-week FVC intervention), an FVC-first group (4-week FVC intervention followed by 4-week PA intervention), and a placebo control group. The intervention content was designed based on the health action process approach model. Data for analyses were collected at baseline (T0), postintervention assessment (T1), and 12-week follow-up assessment (T2). Results: At baseline, 13.9% (77/552) of the participants maintained a healthy lifestyle. After 8 weeks, more (200/552, 36.2%) participants achieved a healthy lifestyle. PA-first and FVC-first groups were, respectively, 3.24 times and 5 times more likely to adopt a healthy lifestyle than the control group at T1. After 12 weeks, 35.5% (196/552) of the participants adopted a healthy lifestyle. Intervention groups were approximately 2.99 times (PA first) and 4.07 times (FVC first) more likely to adopt a healthy lifestyle than the control group at T2. Intervention effects favored both intervention groups in self-efficacy and planning for PA and in intention and planning for FVC compared with the control condition. In addition, changes in PA self-efficacy and FVC intention mediated intervention effectiveness on the immediate lifestyle change after 8 weeks. Changes in FVC intention were identified as a salient mediator for facilitating sustained lifestyle change after 12 weeks. Conclusions: This study provides empirical evidence for the effectiveness of an 8-week theory- and web-based MHBC intervention program on promoting a healthy lifestyle, self-efficacy and planning for PA, and intention and planning for FVC among Chinese college students. These research findings add new knowledge to the underlying psychosocial mechanisms of successful MHBC interventions. Overall, this study has considerable implications for future web-based MHBC research and practice in terms of addressing PA self-efficacy and FVC intention and helping students to adopt and maintain a healthy lifestyle independently of whether PA or FVC is addressed first. Trial Registration: ClinicalTrials.gov NCT03627949; https://clinicaltrials.gov/ct2/show/NCT03627949 %M 36069840 %R 10.2196/37563 %U https://www.jmir.org/2022/9/e37563 %U https://doi.org/10.2196/37563 %U http://www.ncbi.nlm.nih.gov/pubmed/36069840 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e36577 %T The Clinical Effectiveness of Blended Cognitive Behavioral Therapy Compared With Face-to-Face Cognitive Behavioral Therapy for Adult Depression: Randomized Controlled Noninferiority Trial %A Mathiasen,Kim %A Andersen,Tonny E %A Lichtenstein,Mia Beck %A Ehlers,Lars Holger %A Riper,Heleen %A Kleiboer,Annet %A Roessler,Kirsten K %+ Research Unit for Telepsychiatry and E-Mental Health, Department of Clinical Research, University of Southern Denmark, Heden 11, Odense, 5000, Denmark, 45 61677747, kmathiasen@health.sdu.dk %K depression %K depressive disorder, major %K cognitive therapy %K CBT %K treatment outcome %K blended care %K blended cognitive behavioral therapy %K effectiveness %K Denmark %D 2022 %7 7.9.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-based cognitive behavioral therapy (iCBT) has been demonstrated to be cost- and clinically effective. There is a need, however, for increased therapist contact for some patient groups. Combining iCBT with traditional face-to-face (FtF) consultations in a blended format may produce a new treatment format (B-CBT) with multiple benefits from both traditional CBT and iCBT, such as individual adaptation, lower costs than traditional therapy, wide geographical and temporal availability, and possibly lower threshold to implementation. Objective: The primary aim of this study is to compare directly the clinical effectiveness of B-CBT with FtF-CBT for adult major depressive disorder. Methods: A 2-arm randomized controlled noninferiority trial compared B-CBT for adult depression with treatment as usual (TAU). The trial was researcher blinded (unblinded for participants and clinicians). B-CBT comprised 6 sessions of FtF-CBT alternated with 6-8 web-based CBT self-help modules. TAU comprised 12 sessions of FtF-CBT. All participants were aged 18 or older and met the diagnostic criteria for major depressive disorder and were recruited via a national iCBT clinic. The primary outcome was change in depression severity on the 9-item Patient Health Questionnaire (PHQ-9). Secondary analyses included client satisfaction (8-item Client Satisfaction Questionnaire [CSQ-8]), patient expectancy (Credibility and Expectancy Questionnaire [CEQ]), and working (Working Alliance Inventory [WAI] and Technical Alliance Inventory [TAI]). The primary outcome was analyzed by a mixed effects model including all available data from baseline, weekly measures, 3-, 6, and 12-month follow-up. Results: A total of 76 individuals were randomized, with 38 allocated to each treatment group. Age ranged from 18 to 71 years (SD 13.96) with 56 (74%) females. Attrition rate was 20% (n=15), which was less in the FtF-CBT group (n=6, 16%) than in the B-CBT group (n=9, 24%). As many as 53 (70%) completed 9 or more sessions almost equally distributed between the groups (nFtF-CBT=27, 71%; nB-CBT=26, 68%). PHQ-9 reduced 11.38 points in the FtF-CBT group and 8.10 in the B-CBT group. At 6 months, the mean difference was a mere 0.17 points. The primary analyses confirmed large and significant within-group reductions in both groups (FtF-CBT: β=–.03; standard error [SE] 0.00; P<.001 and B-CBT: β=–.02; SE 0.00; P<.001). A small but significant interaction effect was observed between groups (β=.01; SE 0.00; P=.03). Employment status influenced the outcome differently between groups, where the B-CBT group was seen to profit more from not being full-time employed than the FtF group. Conclusions: With large within-group effects in both treatment arms, the study demonstrated feasibility of B-CBT in Denmark. At 6 months’ follow-up, there appeared to be no difference between the 2 treatment formats, with a small but nonsignificant difference at 12 months. The study seems to demonstrate that B-CBT is capable of producing treatment effects that are close to FtF-CBT and that completion rates and satisfaction rates were comparable between groups. However, the study was limited by small sample size and should be interpreted with caution. Trial Registration: ClinicalTrials.gov NCT02796573; https://clinicaltrials.gov/ct2/show/NCT02796573 International Registered Report Identifier (IRRID): RR2-10.1186/s12888-016-1140-y %M 36069798 %R 10.2196/36577 %U https://www.jmir.org/2022/9/e36577 %U https://doi.org/10.2196/36577 %U http://www.ncbi.nlm.nih.gov/pubmed/36069798 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 9 %P e39454 %T Effectiveness and Minimum Effective Dose of App-Based Mobile Health Interventions for Anxiety and Depression Symptom Reduction: Systematic Review and Meta-Analysis %A Lu,Sheng-Chieh %A Xu,Mindy %A Wang,Mei %A Hardi,Angela %A Cheng,Abby L %A Chang,Su-Hsin %A Yen,Po-Yin %+ Department of Symptom Research, University of Texas MD Anderson Cancer Center, 6565 MD Anderson Blvd, Houston, TX, 77030, United States, 1 7137944453, Slu4@mdanderson.org %K mental health %K mobile health %K smartphone apps %K intervention dose effectiveness %K systematic review and meta-analysis %D 2022 %7 7.9.2022 %9 Review %J JMIR Ment Health %G English %X Background: Mobile health (mHealth) apps offer new opportunities to deliver psychological treatments for mental illness in an accessible, private format. The results of several previous systematic reviews support the use of app-based mHealth interventions for anxiety and depression symptom management. However, it remains unclear how much or how long the minimum treatment “dose” is for an mHealth intervention to be effective. Just-in-time adaptive intervention (JITAI) has been introduced in the mHealth domain to facilitate behavior changes and is positioned to guide the design of mHealth interventions with enhanced adherence and effectiveness. Objective: Inspired by the JITAI framework, we conducted a systematic review and meta-analysis to evaluate the dose effectiveness of app-based mHealth interventions for anxiety and depression symptom reduction. Methods: We conducted a literature search on 7 databases (ie, Ovid MEDLINE, Embase, PsycInfo, Scopus, Cochrane Library (eg, CENTRAL), ScienceDirect, and ClinicalTrials, for publications from January 2012 to April 2020. We included randomized controlled trials (RCTs) evaluating app-based mHealth interventions for anxiety and depression. The study selection and data extraction process followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We estimated the pooled effect size using Hedge g and appraised study quality using the revised Cochrane risk-of-bias tool for RCTs. Results: We included 15 studies involving 2627 participants for 18 app-based mHealth interventions. Participants in the intervention groups showed a significant effect on anxiety (Hedge g=–.10, 95% CI –0.14 to –0.06, I2=0%) but not on depression (Hedge g=–.08, 95% CI –0.23 to 0.07, I2=4%). Interventions of at least 7 weeks’ duration had larger effect sizes on anxiety symptom reduction. Conclusions: There is inconclusive evidence for clinical use of app-based mHealth interventions for anxiety and depression at the current stage due to the small to nonsignificant effects of the interventions and study quality concerns. The recommended dose of mHealth interventions and the sustainability of intervention effectiveness remain unclear and require further investigation. %M 36069841 %R 10.2196/39454 %U https://mental.jmir.org/2022/9/e39454 %U https://doi.org/10.2196/39454 %U http://www.ncbi.nlm.nih.gov/pubmed/36069841 %0 Journal Article %@ 2369-3762 %I JMIR Publications %V 8 %N 3 %P e34230 %T Examining the Effectiveness of Web-Based Interventions to Enhance Resilience in Health Care Professionals: Systematic Review %A Henshall,Catherine %A Ostinelli,Edoardo %A Harvey,Jade %A Davey,Zoe %A Aghanenu,Bemigho %A Cipriani,Andrea %A Attenburrow,Mary-Jane %+ Oxford School of Nursing and Midwifery, Oxford Brookes University, Headington Campus, Marston Road Site, Jack Straw's Ln, Marston, Oxford, OX3 0FL, United Kingdom, 44 7768 918298, chenshall@brookes.ac.uk %K resilience %K health care professionals %K depression %K psychological stress %K internet %K mental health %D 2022 %7 6.9.2022 %9 Review %J JMIR Med Educ %G English %X Background: Internationally, the impact of continued exposure to workplace environmental and psychological stressors on health care professionals’ mental health is associated with increased depression, substance misuse, sleep disorders, and posttraumatic stress. This can lead to staff burnout, poor quality health care, and reduced patient safety outcomes. Strategies to improve the psychological health and well-being of health care staff have been highlighted as a critical priority worldwide. The concept of resilience for health care professionals as a tool for negotiating workplace adversity has gained increasing prominence. Objective: This systematic review aims to examine the effectiveness of web-based interventions to enhance resilience in health care professionals. Methods: We searched the PubMed, CINAHL, PsycINFO, and Ovid SP databases for relevant records published after 1990 until July 2021. We included studies that focused on internet-delivered interventions aiming at enhancing resilience. Study quality was assessed with the Risk of Bias 2 tool for randomized controlled trial designs and Joanna Briggs Institute critical appraisal tool for other study designs. The protocol was registered on PROSPERO (International Prospective Register of Systematic Reviews; CRD42021253190). PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed. Results: A total of 8 studies, conducted between 2014 and 2020 and involving 1573 health care workers, were included in the review. In total, 4 randomized controlled trial designs and 4 pre- and postdesign studies were conducted across a range of international settings and health care disciplines. All of these studies aimed to evaluate the impact of web-based interventions on resilience or related symptoms in health care professionals involved in patient-facing care. Interventions included various web-based formats and therapeutic approaches over variable time frames. One randomized controlled trial directly measured resilience, whereas the remaining 3 used proxy measures to measure psychological concepts linked to resilience. Three pretest and posttest studies directly measured resilience, whereas the fourth study used a proxy resilience measure. Owing to the heterogeneity of outcome measures and intervention designs, meta-analysis was not possible, and qualitative data synthesis was undertaken. All studies found that resilience or proxy resilience levels were enhanced in health care workers following the implementation of web-based interventions. The overall risk of bias of all 8 studies was low. Conclusions: The findings indicate that web-based interventions designed to enhance resilience may be effective in clinical practice settings and have the potential to provide support to frontline staff experiencing prolonged workplace stress across a range of health care professional groups. However, the heterogeneity of included studies means that findings should be interpreted with caution; more web-based interventions need rigorous testing to further develop the evidence base. Trial Registration: PROSPERO CRD42021253190; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=253190 %M 36066962 %R 10.2196/34230 %U https://mededu.jmir.org/2022/3/e34230 %U https://doi.org/10.2196/34230 %U http://www.ncbi.nlm.nih.gov/pubmed/36066962 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 5 %N 3 %P e32520 %T Feasibility and Acceptability of Delivering Pivotal Response Treatment for Autism Spectrum Disorder via Telehealth: Pilot Pre-Post Study %A Drapalik,Krista N %A Grodberg,David %A Ventola,Pamela %+ Center for Autism and Related Disabilities, University at Albany, State University of New York, 1535 Western Avenue, Albany, NY, 12203, United States, 1 518 442 5412, kdrapalik@albany.edu %K autism spectrum disorder %K ASD %K pivotal response treatment %K PRT %K telehealth %K parent-implemented intervention %K parent training %K pediatrics %K autism %K children %K digital health %K online modules %K online health %K online treatment %K pilot study %K communication %D 2022 %7 6.9.2022 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Pivotal response treatment (PRT), an evidence-based and parent-delivered intervention, is designed to improve social communication in autistic individuals. Objective: The aim of this study was to assess the feasibility, acceptability, and clinical effects of an online model of PRT delivered via MindNest Health, a telehealth platform that aims to provide self-directed and engaging online modules, real-time coaching and feedback, and accessible stepped-care to large populations of parents seeking resources for their autistic children. Methods: Male and female autistic children, aged 2-7 years with single-word to phrase-level speech, and their parents were eligible to participate in the study. Families were randomized to the online parent training condition or control condition. The online component of the intervention consisted of eight 20-minute online courses of content describing parent training principles in PRT. Four 1-hour videoconferences were held after course 1, course 3, course 5, and course 8. Parents were given 1-2 weeks to complete each course. Parents completed the Client Credibility Questionnaire (CCQ) at week 2 and at the study endpoint, as well as the Behavioral Intervention Rating Scale (BIRS) at the study endpoint to assess parental expectancies, and treatment acceptability and effectiveness. Results: Nine of 14 participants completed the study curriculum in the online parent training condition, and 6 of 12 participants completed the control condition. Thus, a total of 58% (15/26) participants across both groups completed the study curriculum by study closure. Within the online parent training condition, there was a significant increase in mean CCQ total scores, from 25.38 (SD 3.25) at baseline to 27.5 (SD 3.74) at study endpoint (P=.04); mean CCQ confidence scores, from 6.0 (SD 1.07) at baseline to 6.75 (SD 0.89) at study endpoint (P=.02); and mean CCQ other improvement scores, from 5.25 (SD 0.89) at baseline to 6.25 (SD 1.28) at study endpoint (P=.009). Within the control condition, a modest increase in mean CCQ scores was noted (Confidence, difference=+0.25; Recommend, difference=+0.25; Total Score, difference=+0.50), but the differences were not statistically significant (Confidence P=.38, Recommend P=.36, Total Score P=.43). Among the 11 parents who completed the BIRS at the study endpoint, 82% (n=9) endorsed that they slightly agree or agree with over 93% of the Acceptability factor items on the BIRS. Conclusions: The feasibility of this online treatment is endorsed by the high rate of online module completion and attendance to videoconferences within the online parent training group. Acceptability of treatment is supported by strong ratings on the CCQ and significant improvements in scores, as well as strong ratings on the BIRS. This study’s small sample size limits the conclusions that can be drawn; however, the PRT MindNest Health platform holds promise to support parents of autistic children who are unable to access traditional, in-person parent-mediated interventions for their child. %M 36066927 %R 10.2196/32520 %U https://pediatrics.jmir.org/2022/3/e32520 %U https://doi.org/10.2196/32520 %U http://www.ncbi.nlm.nih.gov/pubmed/36066927 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 9 %P e37216 %T Transdiagnostic Internet-Delivered Cognitive Behavioral Therapy for Symptoms of Postpartum Anxiety and Depression: Feasibility Randomized Controlled Trial %A Suchan,Victoria %A Peynenburg,Vanessa %A Thiessen,David %A Nugent,Marcie %A Dear,Blake %A Titov,Nickolai %A Hadjistavropoulos,Heather %+ Department of Psychology, University of Regina, 3737 Wascana Parkway, Regina, SK, S4S 0A2, Canada, 1 306 585 5133, hadjista@uregina.ca %K postpartum depression %K postpartum anxiety %K internet-delivered cognitive behavioral therapy %K transdiagnostic %K therapist assistance %D 2022 %7 6.9.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Postpartum depression (PPD) and postpartum anxiety (PPA) are often comorbid and are associated with significant personal and economic costs. Fewer than half of the mothers experiencing PPD or PPA symptoms receive face-to-face treatment, suggesting a need for alternative delivery formats such as internet-delivered cognitive behavioral therapy (ICBT). Objective: This pilot study aimed to examine the impact of a therapist-assisted, transdiagnostic ICBT program on symptoms of PPD and PPA, as there is only one previous study on transdiagnostic ICBT with this population, which did not include therapist assistance. Methods: Clients endorsing the symptoms of PPD or PPA (N=63) were randomized to an 8-week transdiagnostic ICBT course (Wellbeing Course for New Moms) or to treatment as usual (TAU). Clients completed measures of depression, anxiety, stress, postnatal bonding, and relationship satisfaction, as well as measures of treatment satisfaction and therapeutic alliance, before treatment, after treatment, and at the 1-month follow-up. Outcome measures were also completed at the 6-month follow-up for clients who completed the ICBT course. Results: Both the ICBT and TAU groups experienced statistically significant improvements over time. The ICBT group experienced larger improvements after treatment and at the 1-month follow-up on more measures than the TAU group, with medium between-group Cohen d effects on primary outcome measures for anxiety (Cohen d=0.65, 95% CI 0.13-1.17), PPD (Cohen d=0.52, 95% CI 0.01-1.04), and depression (Cohen d=0.56, 95% CI 0.05-1.08), and on secondary outcome measures of overall distress (Cohen d=0.69, 95% CI 0.17-1.21), anxiety (Cohen d=0.59, 95% CI 0.07-1.11), and stress (Cohen d=0.76, 95% CI 0.23-1.28). Time-by-group interactions for proportional reductions between groups over time were only significant after treatment and at the 1-month follow-up for the primary anxiety measure (P=.006). This study was underpowered for detecting small or medium effects. Overall, clients perceived the treatment as credible, and 95% (21/22) of the clients were satisfied with the treatment content and therapist support. Conclusions: Findings from this pilot study provide preliminary support for transdiagnostic ICBT in treating PPD and PPA symptoms to improve access to psychological treatments. Trial Registration: ClinicalTrials.gov NCT04012580; https://clinicaltrials.gov/ct2/show/NCT04012580 %M 36066958 %R 10.2196/37216 %U https://formative.jmir.org/2022/9/e37216 %U https://doi.org/10.2196/37216 %U http://www.ncbi.nlm.nih.gov/pubmed/36066958 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 5 %N 3 %P e39851 %T The Effects of a Digital Well-being Intervention on Older Adults: Retrospective Analysis of Real-world User Data %A Boucher,Eliane %A Honomichl,Ryan %A Ward,Haley %A Powell,Tyler %A Stoeckl,Sarah Elizabeth %A Parks,Acacia %+ Twill, 114 Fifth Avenue, 10th floor, New York, NY, 10011, United States, 1 432 258 5233, eliane@twill.health %K mobile apps %K mental health %K older adults %K technology adoption %K digital health %K mobile phone %D 2022 %7 2.9.2022 %9 Original Paper %J JMIR Aging %G English %X Background: Digital interventions have been shown to be effective for a variety of mental health disorders and problems. However, few studies have examined the effects of digital interventions in older adults; therefore, little is known about how older adults engage with or benefit from these interventions. Given that adoption rates for technology among people aged ≥65 years remain substantially lower than in the general population and that approximately 20% of older adults are affected by mental health disorders, research exploring whether older adults will use and benefit from digital interventions is needed. Objective: This study aimed to examine the extent to which older adults engaged with a digital well-being intervention (Happify) and whether engaging with this program led to improvements in both subjective well-being and anxiety symptoms. Methods: In this retrospective analysis, we analyzed data from 375 real-world Happify users aged ≥65 years who signed up for the platform between January 1, 2019, and December 23, 2021. Changes in well-being and anxiety symptoms across 42 to 182 days were assessed using responses to the in-app assessment, which users were prompted to take every 2 weeks, and were compared among users who engaged with the program at the recommended level (ie, 2 or more activities per week) or below the recommended level. Results: In all, 30% (113/375) of the sample engaged with the platform at the recommended level (ie, completed an average of 2 or more activities per week), and overall, users completed an average of 43.35 (SD 87.80) activities, ranging from 1 to 786, between their first and last assessment. Users were also active on the platform for an average of 19.36 (SD 27.16) days, ranging from 1 to 152 days. Moreover, older adults who engaged at the recommended level experienced significantly greater improvements in subjective well-being (P=.002) and anxiety symptoms (P<.001) relative to those who completed fewer activities. Conclusions: These data provide preliminary evidence that older adults engage with and benefit from digital well-being interventions. We believe that these findings highlight the importance of considering older adult populations in digital health research. More research is needed to understand potential barriers to using digital interventions among older adults and whether digital interventions should be modified to account for this population’s particular needs (eg, ensuring that the intervention is accessible using a variety of devices). However, these results are an important step in demonstrating the feasibility of such interventions in a population that is assumed to be less inclined toward digital approaches. %M 36053569 %R 10.2196/39851 %U https://aging.jmir.org/2022/3/e39851 %U https://doi.org/10.2196/39851 %U http://www.ncbi.nlm.nih.gov/pubmed/36053569 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 9 %P e36919 %T Integrating Social Determinants of Health With Tobacco Treatment for Individuals With Opioid Use Disorder: Feasibility and Acceptability Study of Delivery Through Text Messaging %A Kathuria,Hasmeena %A Shankar,Divya %A Cobb,Vinson %A Newman,Julia %A Bulekova,Katia %A Werntz,Scott %A Borrelli,Belinda %+ The Pulmonary Center, Boston University School of Medicine, 72 E Concord St, R304, Boston, MA, 02118, United States, 1 6176384860, hasmeena@bu.edu %K text message %K smoking cessation %K opioid use disorder %K tobacco dependence %K tobacco treatment interventions %K mobile phone %D 2022 %7 1.9.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Individuals with opioid use disorder (OUD) have a high prevalence of smoking and frequently experience unmet social determinants of health (SDOH), which may be barriers to smoking cessation. Hospitalization is an opportunity to encourage smoking cessation. Unfortunately, many clinicians do not provide tobacco treatment to support the maintenance of cessation achieved during hospitalization. Interventions are required to support these high-risk individuals after hospital discharge. Objective: This study aimed to test the feasibility and acceptability of a 28-day SMS text messaging program tailored to individuals with OUD, which provides smoking cessation support and addresses unmet SDOH needs. Methods: From July to December 2019, we enrolled 25 individuals who were hospitalized with tobacco dependence and OUD at our large safety net hospital. The SMS text messaging program was initiated during hospitalization and continued for 28 days. Participants were enrolled in either the ready to quit within 30 days or the not ready to quit within 30 days program based on their readiness to quit. Automated SMS text messages were sent twice daily for 4 weeks. The topics included health and cost benefits of quitting, both general and opioid specific (16 messages); managing mood and stress (8 messages); motivation, coping strategies, and encouragement (18 messages); addressing medication misconceptions (5 messages); links to resources to address substance use (2 messages providing links to the Massachusetts Substance Use Helpline and Boston Medical Center resources), tobacco dependence (1 message providing a link to the Massachusetts Quitline), and unmet SDOH needs (6 messages assessing SDOH needs with links to resources if unmet SDOH needs were identified). Questionnaires and interviews were conducted at baseline and at 2 and 4 weeks after enrollment. Results: The participants were 56% (14/25) female, 36% (9/25) African American, 92% (23/25) unemployed, and 96% (24/25) Medicaid insured. Approximately 84% (21/25) activated the program, and none of the participants unsubscribed. Approximately 57% (12/21) completed either the 2- or 4-week questionnaires. Program satisfaction was high (overall mean 6.7, SD 0.8, range 1-7). Many perceived that the SMS text messaging program provided social support, companionship, and motivation to stop smoking. Messages about the health benefits of quitting were well received, whereas messages on how quitting cigarettes may prevent relapse from other substances had mixed views, highlighting the importance of tailoring interventions to patient preferences. Conclusions: SMS text messaging to promote smoking cessation and address SDOH needs may be an effective tool for improving quit rates and health outcomes in individuals with tobacco dependence and OUD. Our study adds to the growing body of evidence that SMS text messaging approaches are feasible and acceptable for providing tobacco treatment to all individuals who smoke, even among low-income populations who have OUD and are not ready to quit. %M 36048509 %R 10.2196/36919 %U https://formative.jmir.org/2022/9/e36919 %U https://doi.org/10.2196/36919 %U http://www.ncbi.nlm.nih.gov/pubmed/36048509 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e40096 %T Characterizing User Engagement With a Digital Intervention for Pain Self-management Among Youth With Sickle Cell Disease and Their Caregivers: Subanalysis of a Randomized Controlled Trial %A Lalloo,Chitra %A Nishat,Fareha %A Zempsky,William %A Bakshi,Nitya %A Badawy,Sherif %A Ko,Yeon Joo %A Dampier,Carlton %A Stinson,Jennifer %A Palermo,Tonya M %+ Department of Child Health Evaluative Sciences, The Hospital for Sick Children, 686 Bay Street, Toronto, ON, M5G 0A4, Canada, 1 416 813 2332 ext 302332, chitra.lalloo@sickkids.ca %K engagement %K adolescents %K caregivers %K sickle cell %K pain %K mHealth %K self-management %K digital health analytics %K mixed methods %K youth %K management %K disease %K acute pain %K chronic pain %K coping %K North America %K intervention %K child %K digital health %K program %D 2022 %7 30.8.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Sickle cell disease (SCD) is characterized by severe acute pain episodes as well as risk for chronic pain. Digital delivery of SCD pain self-management support may enhance pain self-management skills and accessibility for youth. However, little is known about how youth with SCD and their caregivers engage with digital health programs. iCanCope with pain is a digital pain self-management platform adapted for youth with SCD and caregivers through a user-centered design approach. The program was delivered via a website (separate versions for youth and caregiver) and mobile app (youth only). Objective: We aimed to characterize patterns of user engagement with the iCanCope with SCD program among youth with SCD and their caregivers. Methods: A randomized controlled trial was completed across multiple North American SCD clinics. Eligible youth were aged 12-18 years, diagnosed with SCD, English-speaking, and experiencing moderate-to-severe pain interference. Eligible caregivers were English-speaking with a child enrolled in the study. Dyads were randomized to receive the iCanCope intervention or attention-control education for 8-12 weeks. This report focused on engagement among dyads who received the intervention. User-level analytics were captured. Individual interviews were conducted with 20% of dyads. Descriptive statistics characterized quantitative engagement. Content analysis summarized qualitative interview data. Exploratory analysis tested the hypothesis that caregiver engagement would be positively associated with child engagement. Results: The cohort included primarily female (60% [34/57] of youth; 91% [49/56] of caregivers) and Black (>90% of youth [53/57] and caregivers [50/56]) participants. Among 56 dyads given program access, differential usage patterns were observed: both the youth and caregiver engaged (16/56, 29%), only the youth engaged (24/56, 43%), only the caregiver engaged (1/56, 2%), and neither individual engaged (16/56, 29%). While most youth engaged with the program (40/57, 70%), most caregivers did not (39/56, 70%). Youth were more likely to engage with the app than the website (85% [34/57] versus 68% [23/57]), and the most popular content categories were goal setting, program introduction, and symptom history. Among caregivers, program introduction, behavioral plans, and goal setting were the most popular content areas. As hypothesized, there was a moderate positive association between caregiver and child engagement (χ21=6.6; P=.01; ϕ=0.34). Interviews revealed that most dyads would continue to use the program (11/12, 92%) and recommend it to others (10/12, 83%). The reasons for app versus website preference among youth were ease of use, acceptable time commitment, and interactivity. Barriers to caregiver engagement included high time burden and limited perceived relevance of content. Conclusions: This is one of the first studies to apply digital health analytics to characterize patterns of engagement with SCD self-management among youth and caregivers. The findings will be used to optimize the iCanCope with SCD program prior to release. Trial Registration: ClinicalTrials.gov NCT03201874; https://clinicaltrials.gov/ct2/show/NCT03201874 %M 36040789 %R 10.2196/40096 %U https://www.jmir.org/2022/8/e40096 %U https://doi.org/10.2196/40096 %U http://www.ncbi.nlm.nih.gov/pubmed/36040789 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e39182 %T The Effects of Internet-Based Acceptance and Commitment Therapy on Process Measures: Systematic Review and Meta-analysis %A Han,Areum %A Kim,Tae Hui %+ Department of Psychiatry, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju, Gangwon province, 26426, Republic of Korea, 82 337410534, gooddr@yonsei.ac.kr %K acceptance and commitment therapy %K process measure %K internet-based intervention %K digital mental health %K meta-analysis %K mindfulness %K systematic review %D 2022 %7 30.8.2022 %9 Review %J J Med Internet Res %G English %X Background: Acceptance and commitment therapy (ACT) is based on a psychological flexibility model that encompasses 6 processes: acceptance, cognitive defusion, self-as-context, being present, values, and committed action. Objective: This systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to examine the effects of internet-based ACT (iACT) on process measures. Methods: A comprehensive search was conducted using 4 databases. The quality of the included RCTs was assessed using the Cochrane Collaboration Risk of Bias Tool. A random-effects or fixed-effects model was used. Subgroup analyses for each outcome were conducted according to the type of control group, use of therapist guidance, delivery modes, and use of targeted participants, when applicable. Results: A total of 34 RCTs met the inclusion criteria. This meta-analysis found that iACT had a medium effect on psychological flexibility and small effects on mindfulness, valued living, and cognitive defusion at the immediate posttest. In addition, iACT had a small effect on psychological flexibility at follow-up. The overall risk of bias across studies was unclear. Conclusions: Relatively few studies have compared the effects of iACT with active control groups and measured the effects on mindfulness, valued living, and cognitive defusion. These findings support the processes of change in iACT, which mental health practitioners can use to support the use of iACT. %M 36040783 %R 10.2196/39182 %U https://www.jmir.org/2022/8/e39182 %U https://doi.org/10.2196/39182 %U http://www.ncbi.nlm.nih.gov/pubmed/36040783 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e38261 %T Predictors of Dropout in a Digital Intervention for the Prevention and Treatment of Depression in Patients With Chronic Back Pain: Secondary Analysis of Two Randomized Controlled Trials %A Moshe,Isaac %A Terhorst,Yannik %A Paganini,Sarah %A Schlicker,Sandra %A Pulkki-Råback,Laura %A Baumeister,Harald %A Sander,Lasse B %A Ebert,David Daniel %+ Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, P.O. Box 63, Helsinki, 00014, Finland, 358 406324442, isaac.moshe@helsinki.fi %K adherence %K dropout %K law of attrition %K attrition %K digital health %K internet intervention %K depression %K back pain %K comorbidity %K mental health %K eHealth %K mobile phone %D 2022 %7 30.8.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression is a common comorbid condition in individuals with chronic back pain (CBP), leading to poorer treatment outcomes and increased medical complications. Digital interventions have demonstrated efficacy in the prevention and treatment of depression; however, high dropout rates are a major challenge, particularly in clinical settings. Objective: This study aims to identify the predictors of dropout in a digital intervention for the treatment and prevention of depression in patients with comorbid CBP. We assessed which participant characteristics may be associated with dropout and whether intervention usage data could help improve the identification of individuals at risk of dropout early on in treatment. Methods: Data were collected from 2 large-scale randomized controlled trials in which 253 patients with a diagnosis of CBP and major depressive disorder or subclinical depressive symptoms received a digital intervention for depression. In the first analysis, participants’ baseline characteristics were examined as potential predictors of dropout. In the second analysis, we assessed the extent to which dropout could be predicted from a combination of participants’ baseline characteristics and intervention usage variables following the completion of the first module. Dropout was defined as completing <6 modules. Analyses were conducted using logistic regression. Results: From participants’ baseline characteristics, lower level of education (odds ratio [OR] 3.33, 95% CI 1.51-7.32) and both lower and higher age (a quadratic effect; age: OR 0.62, 95% CI 0.47-0.82, and age2: OR 1.55, 95% CI 1.18-2.04) were significantly associated with a higher risk of dropout. In the analysis that aimed to predict dropout following completion of the first module, lower and higher age (age: OR 0.60, 95% CI 0.42-0.85; age2: OR 1.59, 95% CI 1.13-2.23), medium versus high social support (OR 3.03, 95% CI 1.25-7.33), and a higher number of days to module completion (OR 1.05, 95% CI 1.02-1.08) predicted a higher risk of dropout, whereas a self-reported negative event in the previous week was associated with a lower risk of dropout (OR 0.24, 95% CI 0.08-0.69). A model that combined baseline characteristics and intervention usage data generated the most accurate predictions (area under the receiver operating curve [AUC]=0.72) and was significantly more accurate than models based on baseline characteristics only (AUC=0.70) or intervention usage data only (AUC=0.61). We found no significant influence of pain, disability, or depression severity on dropout. Conclusions: Dropout can be predicted by participant baseline variables, and the inclusion of intervention usage variables may improve the prediction of dropout early on in treatment. Being able to identify individuals at high risk of dropout from digital health interventions could provide intervention developers and supporting clinicians with the ability to intervene early and prevent dropout from occurring. %M 36040780 %R 10.2196/38261 %U https://www.jmir.org/2022/8/e38261 %U https://doi.org/10.2196/38261 %U http://www.ncbi.nlm.nih.gov/pubmed/36040780 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e37851 %T Digital Interventions to Enhance Readiness for Psychological Therapy: Scoping Review %A Jardine,Jacinta %A Bowman,Robert %A Doherty,Gavin %+ School of Computer Science and Statistics, Trinity College Dublin, Hamilton Building, College Green, Dublin, D02 W272, Ireland, 353 861505715, jjardine@tcd.ie %K readiness for change %K stages of change %K digital %K motivation %K engagement %K uptake %K mental health %K mental illness %K mobile phone %D 2022 %7 30.8.2022 %9 Review %J J Med Internet Res %G English %X Background: Psychological therapy is an effective treatment method for mental illness; however, many people with mental illness do not seek treatment or drop out of treatment early. Increasing client uptake and engagement in therapy is key to addressing the escalating global problem of mental illness. Attitudinal barriers, such as a lack of motivation, are a leading cause of low engagement in therapy. Digital interventions to increase motivation and readiness for change hold promise as accessible and scalable solutions; however, little is known about the range of interventions being used and their feasibility as a means to increase engagement with therapy. Objective: This review aimed to define the emerging field of digital interventions to enhance readiness for psychological therapy and detect gaps in the literature. Methods: A literature search was conducted in PubMed, PsycINFO, PsycARTICLES, Scopus, Embase, ACM Guide to Computing Literature, and IEEE Xplore Digital Library from January 1, 2006, to November 30, 2021. The PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) methodology was applied. Publications were included when they concerned a digitally delivered intervention, a specific target of which was enhancing engagement with further psychological treatment, and when this intervention occurred before the target psychological treatment. Results: A total of 45 publications met the inclusion criteria. The conditions included depression, unspecified general mental health, comorbid anxiety and depression, smoking, eating disorders, suicide, social anxiety, substance use, gambling, and psychosis. Almost half of the interventions (22/48, 46%) were web-based programs; the other formats included screening tools, videos, apps, and websites. The components of the interventions included psychoeducation, symptom assessment and feedback, information on treatment options and referrals, client testimonials, expectation management, and pro-con lists. Regarding feasibility, of the 16 controlled studies, 7 (44%) measuring actual behavior or action showed evidence of intervention effectiveness compared with controls, 7 (44%) found no differences, and 2 (12%) indicated worse behavioral outcomes. In general, the outcomes were mixed and inconclusive owing to variations in trial designs, control types, and outcome measures. Conclusions: Digital interventions to enhance readiness for psychological therapy are broad and varied. Although these easily accessible digital approaches show potential as a means of preparing people for therapy, they are not without risks. The complex nature of stigma, motivation, and individual emotional responses toward engaging in treatment for mental health difficulties suggests that a careful approach is needed when developing and evaluating digital readiness interventions. Further qualitative, naturalistic, and longitudinal research is needed to deepen our knowledge in this area. %M 36040782 %R 10.2196/37851 %U https://www.jmir.org/2022/8/e37851 %U https://doi.org/10.2196/37851 %U http://www.ncbi.nlm.nih.gov/pubmed/36040782 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 8 %P e35743 %T Feasibility, Usability, and Implementation Context of an Internet-Based Pain Education and Exercise Program for Chronic Musculoskeletal Pain: Pilot Trial of the ReabilitaDOR Program %A Fioratti,Iuri %A Miyamoto,Gisela Cristiane %A Fandim,Junior Vitorino %A Ribeiro,Camila Pereira Pontes %A Batista,Geovana Domingues %A Freitas,Gabriella Evangelista %A Palomo,Andressa Santos %A Reis,Felipe José Jandré dos %A Costa,Leonardo Oliveira Pena %A Maher,Christopher G %A Saragiotto,Bruno Tirotti %+ Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galero, 448, Tatuapé, São Paulo, 03071-000, Brazil, 55 11 970127143, iurifioratti@gmail.com %K telerehabilitation %K musculoskeletal pain %K implementation science %K feasibility study %K chronic pain %K pain %K pilot study %K eHealth %K exercise %K telehealth %K self-management %D 2022 %7 30.8.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Internet-based self-management programs and telerehabilitation initiatives have increased and have been extensively used for delivering health care in many areas. These programs overcome common barriers that patients face with traditional face-to-face health care, such as travel expenditures, lack of time, and high demand on the public health system. During the COVID-19 pandemic, this mode of web-based health care delivery had become more popular. However, there is still a lack of studies testing this mode of delivery in low- and middle-income countries. To gain a better understanding of the context, feasibility, and factors involved in the implementation of a web-based program, pilot and implementation studies are necessary. These studies can better inform whether a strategy is feasible, acceptable, and adequate for its purposes and for optimizing resource allocation. Objective: This study aims to evaluate the feasibility, usability, and implementation context of a self-management internet-based program based on exercises and pain education (ReabilitaDOR) in people with chronic musculoskeletal pain and to compare this program with a program using only a web-based self-management booklet. Methods: The study design was a parallel pilot study of a prospectively registered, assessor-blinded, 2-arm randomized controlled trial with economic evaluation. This study was performed using waiting lists of physiotherapy and rehabilitation centers and advertisements on social media networks. The participants were 65 patients with chronic musculoskeletal pain aged between 18 and 60 years. The effects of an 8-week telerehabilitation program based on exercises and pain education (intervention group) were compared with those of a program based only on a web-based self-management booklet (control group). The main outcome measures were implementation outcomes of patients’ perceptions of acceptability, appropriateness, feasibility, and usability of the program and the societal costs and feasibility of the main trial at 8-week posttreatment follow-up. Adverse events were also analyzed. Results: In total, 56 participants were analyzed at the 8-week follow-up. The intervention group showed responses with a mean of 4.5 (SD 0.6) points for acceptability, 4.5 (SD 0.5) points for appropriateness, and 4.5 (SD 0.6) points for feasibility measured on a 1 to 5 scale. All patients in the intervention group showed satisfactory responses to the system usability outcome. There is satisfactory evidence for the feasibility of the main trial. For costs related to the interventions, health care, patients, and loss of productivity at 8 weeks, we found a total expenditure of US $278.30 per patient in the intervention group and US $141.52 per patient in the control group. No adverse events were reported during the intervention period. Conclusions: We found that the ReabilitaDOR program is feasible, appropriate, and acceptable from the users’ implementation perspective. This system was considered usable by all the participants, and the main trial seemed feasible. Cost data were viable to be collected, and the program is likely to be safe. Trial Registration: ClinicalTrials.gov NCT04274439; https://clinicaltrials.gov/ct2/show/NCT04274439 %M 35776863 %R 10.2196/35743 %U https://formative.jmir.org/2022/8/e35743 %U https://doi.org/10.2196/35743 %U http://www.ncbi.nlm.nih.gov/pubmed/35776863 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 8 %P e34556 %T Using PrEP and Doing it for Ourselves (UPDOs Protective Styles), a Web-Based Salon Intervention to Improve Uptake of Pre-exposure Prophylaxis Among Black Women: Protocol for a Pilot Feasibility Study %A Randolph,Schenita D %A Johnson,Ragan %A Johnson,Allison %A Keusch,Lana %+ Duke University School of Nursing, Duke University, 307 Trent Drive, Durham, NC, 27710, United States, 1 3363148759, schenita.randolph@duke.edu %K HIV prevention %K women %K PrEP uptake %K application %K web-based application %K web-based %K pre-exposure prophylaxis %K prophylaxis %K mixed-method %K community engagement %K pilot test %K HIV %D 2022 %7 30.8.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Multilevel interventions are necessary to address the complex social contributors to health that limit pre-exposure prophylaxis use among Black women, including medical distrust, pre-exposure prophylaxis stigma, and access to equitable health care. Strategies to improve knowledge, awareness, and uptake of pre-exposure prophylaxis among Black women will be more successful if information-sharing and implementation take place within trusted environments. Providing women with information through trusted cultural and social channels can effectively support informed decision-making about pre-exposure prophylaxis for themselves and members of their social networks who are eligible for pre-exposure prophylaxis. Objective: The goal of this project is to improve knowledge, awareness, uptake, and trust of pre-exposure prophylaxis, as well as reduce pre-exposure prophylaxis stigma, among Black women living in the US South. Methods: This multilevel, mixed methods study uses a community-engagement approach to develop and pilot test a salon-based intervention. There are three components of this intervention: (1) stylist training, (2) women-focused entertainment videos and modules, and (3) engagement of a pre-exposure prophylaxis navigator. First, stylist training will be provided through two 2-hour training sessions delivered over 2 consecutive weeks. We will use a pre- and posttest design to examine knowledge and awareness improvement of pre-exposure prophylaxis among the stylists. Upon full completion of training, the stylists will receive a certificate of completion and “Ask Me about PrEP” signage for their beauty salons. Second, together with the community, we have codeveloped a 4-part entertainment series (The Wright Place) that uses culturally and socially relevant stories to highlight key messages about (1) HIV, (2) pre-exposure prophylaxis, and (3) Black women’s social contributors to health. Quantitative and qualitative measures will be used in a pre- and posttest design to examine pre-exposure prophylaxis knowledge, awareness, risk, stigma, trust, intentions, and women’s perceptions of the usability and acceptability of the overall intervention and its implementation strategies. A video blog will be provided after each video. Third, participants will have access through an email or text message link to a pre-exposure prophylaxis navigator, who will respond to them privately to answer questions or make referrals for pre-exposure prophylaxis as requested. Results: This project was funded in October 2020 by Gilead Sciences and was approved by the Duke University School of Nursing institutional review board in April 2021 (Pro00106307). Intervention components were developed in partnership with community partners in the first year. Data collection for phase 1 began in April 2022. Data collection for phase 2 began in May 2022. The study will be complete by October 2022. Conclusions: Multilevel interventions that consider the assets of the community have promise for promoting health among Black women who have influence within their social networks. The findings of this study have the potential to be generalizable to other populations. International Registered Report Identifier (IRRID): PRR1-10.2196/34556 %M 36040785 %R 10.2196/34556 %U https://www.researchprotocols.org/2022/8/e34556 %U https://doi.org/10.2196/34556 %U http://www.ncbi.nlm.nih.gov/pubmed/36040785 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e40015 %T Testing the Effectiveness of an Animated Decision Aid to Improve Recruitment of Control Participants in a Case-Control Study: Web-Based Experiment %A Stoffel,Sandro T %A Law,Jing Hui %A Kerrison,Robert %A Brewer,Hannah R %A Flanagan,James M %A Hirst,Yasemin %+ Department of Behavioural Science and Health, University College London, Gower Street, London, WC1E 6BT, United Kingdom, 44 2076791615, y.hirst@ucl.ac.uk %K animation %K research participation %K online experiment %K case-control %K recruitment %K decision %K effectiveness %K epidemiology %K recruitment %K online %K experiment %K volunteer %K survey %K willingness %K data %K health research %K research %D 2022 %7 26.8.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Participation in case-control studies is crucial in epidemiological research. The self-sampling bias, low response rate, and poor recruitment of population representative controls are often reported as limitations of case-control studies with limited strategies to improve participation. With greater use of web-based methods in health research, there is a further need to understand the effectiveness of different tools to enhance informed decision-making and willingness to take part in research. Objective: This study tests whether the inclusion of an animated decision aid in the recruitment page of a study website can increase participants’ intentions to volunteer as controls. Methods: A total of 1425 women were included in a web-based experiment and randomized to one of two experimental conditions: one in which they were exposed to a simulated website that included the animation (animation; n=693, 48.6%), and one in which they were exposed to the simulated website without the animation (control; n=732, 51.4%). The simulated website was adapted from a real website for a case-control study, which invites people to consider taking part in a study that investigates differences in purchasing behaviors between women with and without ovarian cancer and share their loyalty card data collected through 2 high street retailers with the researchers. After exposure to the experimental manipulation, participants were asked to state (1) their intention to take part in the case-control study, (2) whether they would be willing to share their loyalty card for research, and (3) their willingness to be redirected to the real website after completing the survey. Data were assessed using ordinal and binary logistic regression, reported in percentages (%), adjusted odds ratio (AOR), and 95% confidence intervals. Results: Including the animation in the simulated website did not increase intentions to participate in the study (AOR 1.09; 95% CI 0.88-1.35) or willingness to visit the real study website after the survey (control 50.5% vs animation 52.6%, AOR 1.08; 95% CI 0.85-1.37). The animation, however, increased the participants’ intentions to share the data from their loyalty cards for research in general (control 17.9% vs animation 26%; AOR 1.64; 95% CI 1.23-2.18). Conclusions: While the results of this study indicate that the animated decision aid did not lead to greater intention to take part in our web-based case-control study, they show that they can be effective in increasing people’s willingness to share sensitive data for health research. %M 36018628 %R 10.2196/40015 %U https://www.jmir.org/2022/8/e40015 %U https://doi.org/10.2196/40015 %U http://www.ncbi.nlm.nih.gov/pubmed/36018628 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 8 %P e39885 %T An e–Mental Health Resource for COVID-19–Associated Stress Reduction: Mixed Methods Study of Reach, Usability, and User Perceptions %A Minian,Nadia %A Gayapersad,Allison %A Saiva,Anika %A Dragonetti,Rosa %A Kidd,Sean A %A Strudwick,Gillian %A Selby,Peter %+ Nicotine Dependence Service, Centre for Addiction and Mental Health, 1025 Queen Street West, Toronto, ON, M6H 1H4, Canada, 1 416 535 8501, peter_selby@camh.net %K COVID-19 %K website %K stress %K mental health %K eHealth %K internet-based intervention %K mixed methods evaluation %K usability %K digital health %K health informatics %D 2022 %7 26.8.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: COVID-19 and its public health response are having a profound effect on people’s mental health. To provide support during these times, Canada’s largest mental health and addiction teaching hospital (Centre for Addiction and Mental Health [CAMH]) launched the Mental Health and COVID-19 Pandemic website on March 18, 2020. This website was designed to be a nonstigmatizing psychoeducational resource for people experiencing mild to moderate distress due to COVID-19 and the public health response to the pandemic. Objective: The aim of this study was to examine the reach, usability, and user perceptions of the CAMH Mental Health and COVID-19 Pandemic website. Methods: This study used a mixed methods sequential explanatory design approach, which consisted of the following 2 distinct phases: (1) quantitative data collection and analysis and (2) qualitative semistructured interviews. In phase 1, we analyzed Google Analytics data to understand how many people visited the website and which were the most visited pages. We conducted a survey to identify users’ sociodemographic backgrounds, and assess the usability of the website using the System Usability Scale and users’ subjective stress levels using the Perceived Stress Scale (PSS-10). For phase 2, we conducted semistructured interviews to explore user experiences; user motivation, engagement, satisfaction, and perception of the stress reduction strategies; reflections of the website’s functionality, ease of use, navigation, and design; and recommendations for improvement. Results: Google Analytics results showed 146,978 unique users from June 2020 to March 2021. Most users were from Canada (130,066, 88.5%). Between February 20, 2021, and June 4, 2021, 152 users completed the survey. Most users identified as white, female, and having at least a college degree. Based on the PSS-10 scores, most participants were experiencing moderate to high stress when they visited the website. Users rated the usability of the website as acceptable. Ten users completed in-depth interviews between May 2021 and June 2021. Positive feedback related to the content was that the website was a trustworthy source of mental health information with helpful evidence-based stress reduction strategies. Areas for improvement included the text heavy design of the website, wider dissemination/marketing, and greater accessibility of the website to meet the needs of diverse populations. Conclusions: Adding stress reduction resources to a website from a well-respected institution may be a practical method to increase awareness and access to evidence-based stress reduction resources during times of crisis, where there is severe disruption to usual health care contacts. Efforts to ensure that these resources are more widely accessed, especially by diverse populations, are needed. %M 35960596 %R 10.2196/39885 %U https://mental.jmir.org/2022/8/e39885 %U https://doi.org/10.2196/39885 %U http://www.ncbi.nlm.nih.gov/pubmed/35960596 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 8 %P e25716 %T Self-help Digital Interventions Targeted at Improving Psychological Well-being in Young People With Perceived or Clinically Diagnosed Reduced Well-being: Systematic Review %A Babbage,Camilla M %A Jackson,Georgina M %A Davies,E Bethan %A Nixon,Elena %+ National Institute for Health and Care Research (NIHR) MindTech Medtech Co-operative, Mental Health & Clinical Neurosciences, Institute of Mental Health, University of Nottingham, University Of Nottingham Innovation Park, Nottingham, NG7 2TU, United Kingdom, 44 1158232438, Camilla.Babbage@nottingham.ac.uk %K digital health interventions %K psychological well-being %K mental well-being %K mental disorders %K mental health %K children and young people %K self-help %K systematic review %D 2022 %7 26.8.2022 %9 Review %J JMIR Ment Health %G English %X Background: Levels of well-being are declining, whereas rates of mental health problems remain high in young people. The World Health Organization defines mental health as not merely the absence of mental disorder but also includes social and psychological well-being as integral to positive mental health, highlighting that mental health is applicable to young people with mental health conditions and those without a diagnosis of a mental health condition. Reduced mental well-being have been identified in studies of young people with clinical populations, as well as in populations consisting of nonclinical young people. Self-help digital interventions can be delivered at mass at a low cost and without the need for trained input, thereby facilitating access to support for well-being. Self-help interventions are effective in young people with mental health conditions, but systematic reviews of such studies have been limited to randomized controlled trials, have not included reduced well-being as an inclusion criterion, and do not consider engagement factors such as retention. Objective: The objective of this study was to systematically review all controlled studies of digitally delivered, self-administered interventions for young people aged 9 to 25 years, with perceived or clinically diagnosed reduced psychological well-being. Participant retention and effectiveness of the interventions were also explored. Methods: A systematic search of the PsycInfo, EMBASE, Cochrane, Scopus, and MEDLINE databases from inception to 2021, reference searches of relevant papers, and gray literature was carried out for digitally controlled studies conducted with young people with perceived or clinically diagnosed reduced well-being, aimed at improving psychological well-being. Data were extracted to identify the effectiveness and retention rates of the interventions and the quality of the studies. Results: Overall, 1.04% (12/1153) of studies met the inclusion criteria: 83% (10/12) of studies were randomized controlled trials and 17% (2/12) were controlled pre-post studies. Most (6/12, 50%) studies aimed to improve symptoms of depression; 3 interventions aimed at both anxiety and depressive symptoms and 2 studies aimed at improving social functioning difficulties. Owing to the high risk of bias across interventions and lack of similar outcome measures, a meta-analysis was not conducted. Retention rates across studies were regarded as good, with moderate to high retention. Overall, the findings indicated that predominantly self-administered self-help interventions improved well-being in the areas targeted by the intervention and identified additional areas of well-being that were positively affected by interventions. Few interventions supported psychological well-being that was different from those used by young people with a clinical diagnosis of mental illness or young people from neurodiverse backgrounds. Conclusions: The findings, along with the advantages of self-help interventions, highlight the need for upscaling self-help interventions to better support vulnerable populations of young people who experience poor psychological well-being. Trial Registration: PROSPERO CRD42019129321; https://tinyurl.com/4fb2t4fz %M 36018675 %R 10.2196/25716 %U https://mental.jmir.org/2022/8/e25716 %U https://doi.org/10.2196/25716 %U http://www.ncbi.nlm.nih.gov/pubmed/36018675 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 5 %N 3 %P e34721 %T Evaluation of Positive Choices, a National Initiative to Disseminate Evidence-Based Alcohol and Other Drug Prevention Strategies: Web-Based Survey Study %A Stapinski,Lexine Ann %A Nepal,Smriti %A Guckel,Tara %A Grummitt,Lucinda Rachel %A Chapman,Cath %A Lynch,Samantha Jane %A Lawler,Siobhan Maree %A Teesson,Maree %A Newton,Nicola Clare %+ The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Level 6 Jane Foss Russell Building, G02, Camperdown, 2006, Australia, 61 0426200221, tara.guckel@sydney.edu.au %K alcohol and other drugs %K prevention %K adolescence %K schools %K drug prevention %K drug prevention website %D 2022 %7 26.8.2022 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: To prevent adolescents from initiating alcohol and other drug use and reduce the associated harms, effective strategies need to be implemented. Despite their availability, effective school-based programs and evidence-informed parental guidelines are not consistently implemented. The Positive Choices alcohol and other drug prevention initiative and website was launched to address this research and practice gap. The intended end users were school staff, parents, and school students. An 8-month postlaunch evaluation of the website showed that end users generally had positive feedback on the website’s usability, and following its use, most of them would consider the evidence base and effectiveness of drug education resources. This study extends this initial evaluation by examining the effectiveness and impact of the Positive Choices initiative over a 3-year period. Objective: Guided by the five dimensions of the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework, the study assessed the impact of the Positive Choices initiative in increasing awareness and implementation of evidence-based drug prevention. Methods: Data were collected between 2017 and 2019, using web-based evaluation and community awareness surveys. Data from the surveys were merged to examine reach, effectiveness, adoption, implementation, and maintenance using descriptive statistics. Google Analytics was used to further understand the reach of the website. The System Usability Scale was used to measure website usability. In addition, inductive analysis was used to assess the participants’ feedback about Positive Choices. Results: A total of 5 years after launching, the Positive Choices website has reached 1.7 million users. A national Australian campaign increased awareness from 8% to 14% among school staff and from 15% to 22% among parents after the campaign. Following a brief interaction with the website, most participants, who were not already following the recommended strategies, reported an intention to shift toward evidence-based practices. The System Usability Scale score for the website was good for both user groups. The participants intended to maintain their use of the Positive Choices website in the future. Both user groups reported high level of confidence in communicating about topics related to alcohol and other drugs. Participants’ suggestions for improvement informed a recent website update. Conclusions: The Positive Choices website has the capacity to be an effective strategy for disseminating evidence-based drug prevention information and resources widely. The findings highlight the importance of investing in ongoing maintenance and promotion to enhance awareness of health websites. With the increased use and acceptability of health education websites, teams should ensure that websites are easy to navigate, are engaging, use simple language, contain evidence-informed resources, and are supported by ongoing promotional activities. %M 36018617 %R 10.2196/34721 %U https://pediatrics.jmir.org/2022/3/e34721 %U https://doi.org/10.2196/34721 %U http://www.ncbi.nlm.nih.gov/pubmed/36018617 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e37000 %T Web-Based Educational Intervention to Improve Knowledge of Systematic Reviews Among Health Science Professionals: Randomized Controlled Trial %A Krnic Martinic,Marina %A Čivljak,Marta %A Marušić,Ana %A Sapunar,Damir %A Poklepović Peričić,Tina %A Buljan,Ivan %A Tokalić,Ružica %A Mališa,Snježana %A Neuberg,Marijana %A Ivanišević,Kata %A Aranza,Diana %A Skitarelić,Nataša %A Zoranić,Sanja %A Mikšić,Štefica %A Čavić,Dalibor %A Puljak,Livia %+ Catholic University of Croatia, Ilica 242, Zagreb, 10000, Croatia, 385 13706 600, livia.puljak@gmail.com %K educational intervention %K systematic review %K health science professionals %K knowledge %K randomized controlled trial %D 2022 %7 25.8.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Lack of knowledge of systematic reviews (SRs) could prevent individual health care professionals from using SRs as a source of information in their clinical practice or discourage them from participating in such research. Objective: In this randomized controlled trial, we evaluated the effect of a short web-based educational intervention on short-term knowledge of SRs. Methods: Eligible participants were 871 Master’s students of university health sciences studies in Croatia; 589 (67.6%) students who agreed to participate in the trial were randomized using a computer program into 2 groups. Intervention group A (294/589, 49.9%) received a short web-based educational intervention about SR methodology, and intervention group B (295/589, 50.1%) was presented with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) checklist. The participants’ knowledge of SRs was assessed before and after the intervention. The participants could not be blinded because of the nature of the intervention. The primary outcome was the difference in the percentage of correct answers about SR methodology per participant between the groups after the intervention, expressed as relative risk and 95% CI. Results: Results from 162 and 165 participants in the educational intervention and PRISMA checklist groups, respectively, were available for analysis. Most of them (educational intervention group: 130/162, 80.2%; PRISMA checklist group: 131/165, 79.4%) were employed as health care professionals in addition to being health sciences students. After the intervention, the educational intervention group had 23% (relative risk percentage) more correct answers in the postintervention questionnaire than the PRISMA checklist group (relative risk=1.23, 95% CI 1.17-1.29). Conclusions: A short web-based educational intervention about SRs is an effective tool for short-term improvement of knowledge of SRs among health care studies students, most of whom were also employed as health care professionals. Further studies are needed to explore the long-term effects of the tested education. Trial Registration: OSF Registries 10.17605/OSF.IO/RYMVC; https://osf.io/rymvc %M 36006686 %R 10.2196/37000 %U https://www.jmir.org/2022/8/e37000 %U https://doi.org/10.2196/37000 %U http://www.ncbi.nlm.nih.gov/pubmed/36006686 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e36000 %T Effects of a WeChat-Based Life Review Program for Patients With Digestive System Cancer: 3-Arm Parallel Randomized Controlled Trial %A Zheng,Meihua %A Zhang,Xiaoling %A Xiao,Huimin %+ School of Nursing, Fujian Medical University, No 1 Xuefu North Road, University Town, Shangjie Town, Minhou County, Fuzhou City, Fujian Province, 350122, China, 86 13860692061, huimin_xiao@126.com %K digestive system cancer %K life review %K digital technology %K anxiety %K depression %K hope %K self-transcendence %K cancer %K randomized controlled trial %K distress %K psychological %K digestive system %D 2022 %7 25.8.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Patients with digestive system cancer often experience psychospiritual distress. Life review is an evidence-based psychological intervention for patients with cancer, but the effects of digital life review programs are unclear, especially for patients with digestive system cancer. Objective: We examined the effects of a WeChat-based life review program on the psychospiritual well-being of patients with digestive system cancer. Methods: This study was a 3-arm parallel randomized controlled trial. Eligible patients with digestive system cancer were recruited from a university hospital in Fujian, China. They were randomized to a life review group and 2 control groups. All participants received routine care, and the life review group also received the 4-week WeChat-based life review program. Control group 1 also received a 4-week program of friendly visiting. Anxiety, depression, hope, and self-transcendence were measured at baseline and 2 days, 1 month, and 6 months after the intervention. Results: A total of 150 participants were randomly allocated to the WeChat-based life review group (n=50), control group 1 (n=50), or control group 2 (n=50). The overall dropout rate was 10% (15/150), and 92% (46/50) of participants in the the life review group completed the intervention. Significant interaction effects for time and group membership were found for anxiety (P<.001), depression (P<.001), hope (P<.001), and self-transcendence (P<.001) at all follow-up time points. For anxiety and depression, the scores did not differ significantly between the life review group and control group 1 on day 2 (P=.80 for anxiety, P=.51 for depression), but the scores were significantly lower in the life review group at month 1 and month 6 (P=.02 for anxiety at both months 1 and 6; P=.003 and P<.001 for depression at months 1 and 6, respectively). Significant increases in hope and self-transcendence were revealed in the life review group compared to control group participants at all follow-up sessions. Conclusions: The WeChat-based life review program was effective in reducing anxiety and depressive symptoms and in improving the level of hope and self-transcendence among patients with digestive system cancer. Though friendly visiting can also help to relieve anxiety, its effects are short-term. Trial Registration: Chinese Clinical Trial Registry ChiCTR-IOR-17011998; https://tinyurl.com/5acycpd4 %M 36006665 %R 10.2196/36000 %U https://www.jmir.org/2022/8/e36000 %U https://doi.org/10.2196/36000 %U http://www.ncbi.nlm.nih.gov/pubmed/36006665 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e34229 %T The Barriers and Facilitators of eHealth-Based Lifestyle Intervention Programs for People With a Low Socioeconomic Status: Scoping Review %A Al-Dhahir,Isra %A Reijnders,Thomas %A Faber,Jasper S %A van den Berg-Emons,Rita J %A Janssen,Veronica R %A Kraaijenhagen,Roderik A %A Visch,Valentijn T %A Chavannes,Niels H %A Evers,Andrea W M %+ Faculty of Social and Behavioral Sciences, Health, Medical and Neuropsychology Unit, Leiden University, Wassenaarseweg 52, Leiden, 2333 AK, Netherlands, 31 715273627, i.al-dhahir@fsw.leidenuniv.nl %K eHealth %K lifestyle interventions %K health behaviors %K low socioeconomic status %K intervention development %K barriers %K facilitators %K prevention %K intervention evaluation %D 2022 %7 24.8.2022 %9 Review %J J Med Internet Res %G English %X Background: Promoting health behaviors and preventing chronic diseases through a healthy lifestyle among those with a low socioeconomic status (SES) remain major challenges. eHealth interventions are a promising approach to change unhealthy behaviors in this target group. Objective: This review aims to identify key components, barriers, and facilitators in the development, reach, use, evaluation, and implementation of eHealth lifestyle interventions for people with a low SES. This review provides an overview for researchers and eHealth developers, and can assist in the development of eHealth interventions for people with a low SES. Methods: We performed a scoping review based on Arksey and O’Malley’s framework. A systematic search was conducted on PubMed, MEDLINE (Ovid), Embase, Web of Science, and the Cochrane Library, using terms related to a combination of the following key constructs: eHealth, lifestyle, low SES, development, reach, use, evaluation, and implementation. There were no restrictions on the date of publication for articles retrieved upon searching the databases. Results: The search identified 1323 studies, of which 42 met our inclusion criteria. An update of the search led to the inclusion of 17 additional studies. eHealth lifestyle interventions for people with a low SES were often delivered via internet-based methods (eg, websites, email, Facebook, and smartphone apps) and offline methods, such as texting. A minority of the interventions combined eHealth lifestyle interventions with face-to-face or telephone coaching, or wearables (blended care). We identified the use of different behavioral components (eg, social support) and technological components (eg, multimedia) in eHealth lifestyle interventions. Facilitators in the development included iterative design, working with different disciplines, and resonating intervention content with users. Facilitators for intervention reach were use of a personal approach and social network, reminders, and self-monitoring. Nevertheless, barriers, such as technological challenges for developers and limited financial resources, may hinder intervention development. Furthermore, passive recruitment was a barrier to intervention reach. Technical difficulties and the use of self-monitoring devices were common barriers for users of eHealth interventions. Only limited data on barriers and facilitators for intervention implementation and evaluation were available. Conclusions: While we found large variations among studies regarding key intervention components, and barriers and facilitators, certain factors may be beneficial in building and using eHealth interventions and reaching people with a low SES. Barriers and facilitators offer promising elements that eHealth developers can use as a toolbox to connect eHealth with low SES individuals. Our findings suggest that one-size-fits-all eHealth interventions may be less suitable for people with a low SES. Future research should investigate how to customize eHealth lifestyle interventions to meet the needs of different low SES groups, and should identify the components that enhance their reach, use, and effectiveness. %M 36001380 %R 10.2196/34229 %U https://www.jmir.org/2022/8/e34229 %U https://doi.org/10.2196/34229 %U http://www.ncbi.nlm.nih.gov/pubmed/36001380 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 11 %N 2 %P e37315 %T Web-Based Interventions to Promote Healthy Lifestyles for Older Adults: Scoping Review %A Lavoie,Audrey %A Dubé,Véronique %+ Faculty of Nursing, Université de Montréal, 2375 Chem de la Côte-Sainte-Catherine, Montreal, QC, H3T 1A8, Canada, 1 514 890 8000 ext 31591, audrey.lavoie.7@umontreal.ca %K aged %K behavior change %K components %K effects %K healthy lifestyle %K web-based intervention %D 2022 %7 23.8.2022 %9 Review %J Interact J Med Res %G English %X Background: With the aging of the population and rising rates of chronic diseases, web-based interventions could be considered to support older adults in adopting healthy lifestyles. To date, published knowledge syntheses have focused on quantitative studies among older adults aged ≥50 years. However, those aged ≥65 years may have different needs to be met by these interventions because of the biological and physiological changes associated with aging, and qualitative studies could help advance knowledge in this field. Objective: The objective of this scoping review is to explore the extent of the literature on web-based interventions aimed at promoting healthy lifestyles among people aged ≥65 years. Methods: A scoping review was conducted based on the framework proposed by Levac et al. Six databases (ie, MEDLINE, CINAHL, PsycINFO, Web of Science, the Cochrane Database of Systematic Reviews, and the Joanna Briggs Library) and gray literature (ie, Google Scholar and OpenGrey) were searched. The final search was conducted on June 23, 2021. The studies were selected by 2 persons (AL and ML) independently. The included studies were systematic reviews and qualitative and quantitative studies focusing on web-based interventions to promote healthy lifestyles in people aged ≥65 years that were published in French or English between 1990 and 2021. Data were extracted in a table and synthesized based on the conceptualization of web-based interventions (ie, according to the use parameters, behavior change techniques, delivery modes, and theories). A thematic analysis was performed. Results: In total, 20 articles were included in this review, which represents studies focused on 11 distinct interventions. All of the interventions (11/11, 100%) aimed to promote physical activity among older adults. The number of intervention sessions varied from 5 to 16, with a frequency from daily to once every 2 weeks. Diverse delivery modes such as electronic diary, video, and phone call were found. The most used behavior change techniques were instruction, feedback, and self-monitoring. Few interventions (6/11, 55%) were based on a theory. A favorable trend was observed in increasing physical activity, and 5 themes emerged that appeared to be central to behavior change among older adults: motivation, support, tailoring, barriers, and perceptions. Conclusions: This scoping review provides a better understanding of the components of web-based interventions and their outcomes on the healthy lifestyles of people aged ≥65 years. These findings could provide important guidance for the design and development of future web-based interventions in this field. Further research is needed to continue the development and evaluation of innovative and accessible interventions to promote healthy lifestyles among older adults. International Registered Report Identifier (IRRID): RR2-10.2196/23207 %M 35998024 %R 10.2196/37315 %U https://www.i-jmr.org/2022/2/e37315 %U https://doi.org/10.2196/37315 %U http://www.ncbi.nlm.nih.gov/pubmed/35998024 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e30581 %T The Impact of a Place-Tailored Digital Health App Promoting Exercise Classes on African American Women’s Physical Activity and Obesity: Simulation Study %A Powell-Wiley,Tiffany M %A Martinez,Marie F %A Tamura,Kosuke %A Neally,Sam J %A O'Shea,Kelly J %A Curlin,Kaveri %A Albarracin,Yardley %A Vijayakumar,Nithya P %A Morgan,Matthew %A Ortiz-Chaparro,Erika %A Bartsch,Sarah M %A Osei Baah,Foster %A Wedlock,Patrick T %A Ortiz-Whittingham,Lola R %A Scannell,Sheryl %A Potharaju,Kameswari A %A Randall,Samuel %A Solano Gonzales,Mario %A Domino,Molly %A Ranganath,Kushi %A Hertenstein,Daniel %A Syed,Rafay %A Weatherwax,Colleen %A Lee,Bruce Y %+ Social Determinants of Obesity and Cardiovascular Risk Laboratory, Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, 10 Center Drive, Bethesda, MD, 20892, United States, 1 (301) 547 5275, tiffany.powell-wiley@nih.gov %K computational modeling %K digital health %K physical activity %K BMI %K obesity %K built environment %K impact %K app %K exercise %K simulation %K intervention %K women %K African American %K agent %D 2022 %7 22.8.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The increasing prevalence of smartphone apps to help people find different services raises the question of whether apps to help people find physical activity (PA) locations would help better prevent and control having overweight or obesity. Objective: The aim of this paper is to determine and quantify the potential impact of a digital health intervention for African American women prior to allocating financial resources toward implementation. Methods: We developed our Virtual Population Obesity Prevention, agent-based model of Washington, DC, to simulate the impact of a place-tailored digital health app that provides information about free recreation center classes on PA, BMI, and overweight and obesity prevalence among African American women. Results: When the app is introduced at the beginning of the simulation, with app engagement at 25% (eg, 25% [41,839/167,356] of women aware of the app; 25% [10,460/41,839] of those aware downloading the app; and 25% [2615/10,460] of those who download it receiving regular push notifications), and a 25% (25/100) baseline probability to exercise (eg, without the app), there are no statistically significant increases in PA levels or decreases in BMI or obesity prevalence over 5 years across the population. When 50% (83,678/167,356) of women are aware of the app; 58.23% (48,725/83,678) of those who are aware download it; and 55% (26,799/48,725) of those who download it receive regular push notifications, in line with existing studies on app usage, introducing the app on average increases PA and decreases weight or obesity prevalence, though the changes are not statistically significant. When app engagement increased to 75% (125,517/167,356) of women who were aware, 75% (94,138/125,517) of those who were aware downloading it, and 75% (70,603/94,138) of those who downloaded it opting into the app’s push notifications, there were statistically significant changes in PA participation, minutes of PA and obesity prevalence. Conclusions: Our study shows that a digital health app that helps identify recreation center classes does not result in substantive population-wide health effects at lower levels of app engagement. For the app to result in statistically significant increases in PA and reductions in obesity prevalence over 5 years, there needs to be at least 75% (125,517/167,356) of women aware of the app, 75% (94,138/125,517) of those aware of the app download it, and 75% (70,603/94,138) of those who download it opt into push notifications. Nevertheless, the app cannot fully overcome lack of access to recreation centers; therefore, public health administrators as well as parks and recreation agencies might consider incorporating this type of technology into multilevel interventions that also target the built environment and other social determinants of health. %M 35994313 %R 10.2196/30581 %U https://www.jmir.org/2022/8/e30581 %U https://doi.org/10.2196/30581 %U http://www.ncbi.nlm.nih.gov/pubmed/35994313 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 10 %N 3 %P e31456 %T Digital Interventions for Emotion Regulation in Children and Early Adolescents: Systematic Review and Meta-analysis %A Reynard,Sally %A Dias,Joao %A Mitic,Marija %A Schrank,Beate %A Woodcock,Kate Anne %+ Centre for Applied Psychology, University of Birmingham, 52 Pritchatts Road, Birmingham, B15 2SA, United Kingdom, 44 0121 414 6036, sallyreynard1@gmail.com %K emotion regulation %K digital interventions %K youth %K systematic review %K meta-analysis %K children %K early adolescents %K serious games %K training %K biofeedback %K mobile phone %D 2022 %7 19.8.2022 %9 Review %J JMIR Serious Games %G English %X Background: Difficulties in emotion regulation are common in adolescence and are associated with poor social and mental health outcomes. However, psychological therapies that promote adaptive emotion regulation may be inaccessible and unattractive to youth. Digital interventions may help address this need. Objective: The aim of this systematic review and meta-analysis was to synthesize evidence on the efficacy, feasibility, and acceptability of emotion regulation digital interventions in children and early adolescents aged 8 to 14 years. Methods: Systematic searches of Web of Science, MEDLINE, PsycINFO, EMBASE, Education Resources Information Centre, ACM Digital Library, and IEEE Xplore up to July 2020 identified 39 studies, of which 11 (28%) were included in the meta-analyses (n=2476 participants). A bespoke tool was used to assess risk of bias. Results: The studies evaluated digital games (27/39, 69%), biofeedback (4/39, 10%), virtual or augmented reality (4/39, 10%), and program or multimedia (4/39, 10%) digital interventions in samples classified as diagnosed, at risk, healthy, and universal. The most consistent evidence came from digital games, which reduced negative emotional experience with a small significant effect, largely in youth at risk of anxiety (Hedges g=–0.19, 95% CI –0.34 to –0.04). In general, digital interventions tended to improve emotion regulation, but this effect was not significant (Hedges g=0.19, 95% CI –0.16 to 0.54). Conclusions: Most feasibility issues were identified in diagnosed youth, and acceptability was generally high across intervention types and samples. Although there is cause to be optimistic about digital interventions supporting the difficulties that youth experience in emotion regulation, the predominance of early-stage development studies highlights the need for more work in this area. %M 35984681 %R 10.2196/31456 %U https://games.jmir.org/2022/3/e31456 %U https://doi.org/10.2196/31456 %U http://www.ncbi.nlm.nih.gov/pubmed/35984681 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e39208 %T Smoking Cessation Smartphone App Use Over Time: Predicting 12-Month Cessation Outcomes in a 2-Arm Randomized Trial %A Bricker,Jonathan B %A Mull,Kristin E %A Santiago-Torres,Margarita %A Miao,Zhen %A Perski,Olga %A Di,Chongzhi %+ Division of Public Health Sciences, Fred Hutch Cancer Center, 1100 Fairview Avenue North, M3-B232, Seattle, WA, 98109, United States, 1 2066675074, jbricker@fredhutch.org %K acceptance and commitment therapy %K ACT %K digital interventions %K eHealth %K engagement %K iCanQuit %K QuitGuide %K mobile health %K mHealth %K smartphone apps %K trajectories %K tobacco %K smoking %K mobile phone %D 2022 %7 18.8.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Little is known about how individuals engage over time with smartphone app interventions and whether this engagement predicts health outcomes. Objective: In the context of a randomized trial comparing 2 smartphone apps for smoking cessation, this study aimed to determine distinct groups of smartphone app log-in trajectories over a 6-month period, their association with smoking cessation outcomes at 12 months, and baseline user characteristics that predict data-driven trajectory group membership. Methods: Functional clustering of 182 consecutive days of smoothed log-in data from both arms of a large (N=2415) randomized trial of 2 smartphone apps for smoking cessation (iCanQuit and QuitGuide) was used to identify distinct trajectory groups. Logistic regression was used to determine the association of group membership with the primary outcome of 30-day point prevalence of smoking abstinence at 12 months. Finally, the baseline characteristics associated with group membership were examined using logistic and multinomial logistic regression. The analyses were conducted separately for each app. Results: For iCanQuit, participants were clustered into 3 groups: “1-week users” (610/1069, 57.06%), “4-week users” (303/1069, 28.34%), and “26-week users” (156/1069, 14.59%). For smoking cessation rates at the 12-month follow-up, compared with 1-week users, 4-week users had 50% higher odds of cessation (30% vs 23%; odds ratio [OR] 1.50, 95% CI 1.05-2.14; P=.03), whereas 26-week users had 397% higher odds (56% vs 23%; OR 4.97, 95% CI 3.31-7.52; P<.001). For QuitGuide, participants were clustered into 2 groups: “1-week users” (695/1064, 65.32%) and “3-week users” (369/1064, 34.68%). The difference in the odds of being abstinent at 12 months for 3-week users versus 1-week users was minimal (23% vs 21%; OR 1.16, 95% CI 0.84-1.62; P=.37). Different baseline characteristics predicted the trajectory group membership for each app. Conclusions: Patterns of 1-, 3-, and 4-week smartphone app use for smoking cessation may be common in how people engage in digital health interventions. There were significantly higher odds of quitting smoking among 4-week users and especially among 26-week users of the iCanQuit app. To improve study outcomes, strategies for detecting users who disengage early from these interventions (1-week users) and proactively offering them a more intensive intervention could be fruitful. %M 35831180 %R 10.2196/39208 %U https://www.jmir.org/2022/8/e39208 %U https://doi.org/10.2196/39208 %U http://www.ncbi.nlm.nih.gov/pubmed/35831180 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 8 %P e37285 %T Examining the Relationship Between Pediatric Behavioral Health and Parent Productivity Through a Parent-Reported Survey in the Time of COVID-19: Exploratory Study %A Grodberg,David %A Bridgewater,Jesse %A Loo,Theoren %A Bravata,Dena %+ Child Study Center, Yale University School of Medicine, 230 S Frontage Rd, New Haven, CT, 06520, United States, 1 2037852513, david.grodberg@yale.edu %K adolescent %K child, family health %K mental health %K behavioral health %K stress %K protective factors %K productivity %K COVID-19 %D 2022 %7 18.8.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Pediatric behavioral health needs skyrocketed during the COVID-19 pandemic. Parents and caregivers lacked access to well-established tools to identify risk and protective factors while also experiencing decreased access to treatment options to meet their families’ behavioral health needs. Objective: The aim of this study is to investigate the associations of known pediatric behavioral health risk factors and parents’ reports of workplace productivity. Methods: A clinical research team at Brightline—a virtual, pediatric behavioral health solution—drew on standardized instruments to create a survey designed to understand pediatric behavioral health conditions, child stress, and family resilience and connection during the COVID-19 pandemic. Multivariable linear regression was used to characterize the relationship between these variables and parents’ reports of workplace productivity. Results: Participants (N=361) completed the survey between October 2020 and November 2021. In the multivariable model, higher pediatric stress and time spent managing children’s behavioral health needs were associated with greater productivity loss among working parents, whereas higher family connection was associated with lower productivity loss. COVID-19 diagnoses among parents and dependents, financial impact of COVID-19 on households, and family resilience were not associated with parents’ workplace productivity. Conclusions: This survey captured child stress, family connection, and productivity as reported by parents and caregivers during the COVID-19 pandemic. Exploratory studies are the first step in understanding the relationship between these variables. The results from this study can empower parents by providing insights to help manage their child’s behavioral health concerns and identify pediatric behavioral health services to aid working parents who are caregivers. %M 35616439 %R 10.2196/37285 %U https://formative.jmir.org/2022/8/e37285 %U https://doi.org/10.2196/37285 %U http://www.ncbi.nlm.nih.gov/pubmed/35616439 %0 Journal Article %@ 2562-7600 %I JMIR Publications %V 5 %N 1 %P e36167 %T Personality, Attitudes, and Behaviors Predicting Perceived Benefit in Online Support Groups for Caregivers: Mixed Methods Study %A Milios,Athena %A Xiong,Ting %A McEwan,Karen %A McGrath,Patrick %+ Centre for Research in Family Health, Izaak Walton Killam Health Centre, 5980 University Ave, Halifax, NS, B3K 6R8, Canada, 1 877 341 8309 ext 7, ting.xiong@dal.ca %K online support groups %K personality %K support group %K online support %K peer support %K caregiver %K caregiving %K caring %K mother %K father %K usage pattern %K extraversion %K neuroticism %K neurotic %K agreeable %K benefit %K eHealth %K Canada %K North America %K parent %K neurodevelopment disorder %K attitude %K online behavior %K emotional support %K perceived benefit %D 2022 %7 18.8.2022 %9 Original Paper %J JMIR Nursing %G English %X Background: Online support groups (OSGs) are distance-delivered, easily accessible health interventions offering emotional, informational, and experience-based support and companionship or network support for caregivers managing chronic mental and physical health conditions. Objective: This study aimed to examine the relative contribution of extraversion, agreeableness, neuroticism, positive attitudes toward OSGs on social networking sites, and typical past OSG use patterns in predicting perceived OSG benefit in an OSG for parents and caregivers of children with neurodevelopmental disorders. Methods: A mixed methods, longitudinal design was used to collect data from 81 parents across Canada. Attitudes toward OSGs and typical OSG use patterns were assessed using the author-developed Attitudes Toward OSGs subscale (eg, “Online support groups are a place to get and give emotional support”) and Past Behaviors in OSGs subscale (eg, “How often would you typically comment on posts?”) administered at baseline—before OSG membership. The personality traits of extraversion, agreeableness, and neuroticism were assessed at baseline using the Ten-Item Personality Inventory. Perceived OSG benefit was assessed using the author-developed Perceived OSG Benefit scale (eg, “Overall, did you feel supported by other members in this group?”), administered 2 months after the initiation of OSG membership. Results: A hierarchical regression analysis found that extraversion was the only variable that significantly predicted perceived OSG benefit (R2=0.125; P<.001). Conclusions: The key suggestions for improving future OSGs were facilitating more in-depth, customized, and interactive content in OSGs. %M 35980741 %R 10.2196/36167 %U https://nursing.jmir.org/2022/1/e36167 %U https://doi.org/10.2196/36167 %U http://www.ncbi.nlm.nih.gov/pubmed/35980741 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 8 %P e37309 %T Evaluation of a Text Messaging Intervention to Promote Preconception Micronutrient Supplement Use: Feasibility Study Nested in the Healthy Life Trajectories Initiative Study in South Africa %A Soepnel,Larske M %A McKinley,Michelle C %A Klingberg,Sonja %A Draper,Catherine E %A Prioreschi,Alessandra %A Norris,Shane A %A Ware,Lisa J %+ SAMRC/Wits Developmental Pathways for Health Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Private Bag X3, Wits, Johannesburg, 2050, South Africa, 27 010 447 3721, larske.soepnel@gmail.com %K preconception health %K micronutrient supplements %K adherence %K behavioral %K SMS text messaging intervention %K mobile health %K mHealth %K radio serial %K mobile phone %D 2022 %7 18.8.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Social messaging strategies such as SMS text messaging and radio are promising avenues for health promotion and behavior change in low- to middle-income settings. However, evidence of their acceptability, feasibility, and impact in the context of young women’s health and micronutrient deficiencies is lacking. Objective: This study aimed to evaluate the feasibility of an automated 2-way text messaging intervention nested in an ongoing preconception health trial, the Healthy Life Trajectories Initiative (HeLTI; HeLTI Bukhali) in Soweto, South Africa. Second, we aimed to evaluate the acceptability of a health promotion radio serial, which aired concurrently in the region. Methods: In this feasibility study, 120 participants enrolled in HeLTI Bukhali between November 2020 and February 2021 received the 6-month 2-way text messaging intervention. Quantitative and qualitative data on intervention acceptability, usability, interaction, perceived benefit, and fidelity were collected during 5 focus group discussions (FGDs) and from study data logs. During the FGDs, data were collected on the acceptability of the radio serial. Following the text messaging intervention, capillary hemoglobin levels were assessed, and a participant questionnaire provided information on adherence and attitudes toward supplements. The text messaging control group comprised the first 120 women recruited from November 2019 to February 2020, who received the Bukhali intervention but not the text messages. Statistical significance testing and a linear mixed model were used for indicative effect comparisons between the text message–receiving and control groups. Results: The text messaging intervention was found to be acceptable and to have perceived benefits, including being reminded to take supplements, gaining knowledge, and feeling supported by the study team. The use of the 2-way text messaging reply function was limited, with only a 10.8% (13/120) response rate by week 24. Barriers to replying included a lack of interest or phone credit and technical issues. Regarding the indicative effect, participants receiving the text messages had higher self-reported adherence at follow-up than the text messaging control group (42/63, 67% vs 33/85, 39% taking supplements every time; P=.02), and altitude-adjusted hemoglobin increased more between baseline and follow-up in the SMS text message–receiving group than in the text messaging control group (1.03, 95% CI 0.49-1.57; P<.001). The radio serial content was acceptable, although few participants reported exposure before the FGD. Conclusions: Women reported that the text messaging intervention was useful and described the benefits of receiving the messages. Examination of hemoglobin status indicated a promising beneficial effect of text messaging support on adherence to micronutrient supplementation, requiring further exploration through randomized controlled studies. Health promotion through radio and text messages were both found to be acceptable, although more research into the radio serial reach among young women is needed. Trial Registration: Pan African Clinical Trials Registry (PACTR) PACTR201903750173871; https://tinyurl.com/4x6n32ff %M 35980731 %R 10.2196/37309 %U https://formative.jmir.org/2022/8/e37309 %U https://doi.org/10.2196/37309 %U http://www.ncbi.nlm.nih.gov/pubmed/35980731 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 8 %P e26237 %T Digital Interventions Supporting Self-care in People With Type 2 Diabetes Across Greater Manchester (Greater Manchester Diabetes My Way): Protocol for a Mixed Methods Evaluation %A Goldthorpe,Joanna %A Allen,Thomas %A Brooks,Joanna %A Kontopantelis,Evangelos %A Holland,Fiona %A Moss,Charlie %A Wake,Deborah J %A Brodie,Doogie %A Cunningham,Scott G %A Kanumilli,Naresh %A Bishop,Hannah %A Jones,Ewan %A Milne,Nicola %A Ball,Steve %A Jenkins,Mark %A Nicinska,Bogna %A Ratto,Martina %A Morgan-Curran,Michael %A Johnson,Gemma %A Rutter,Martin K %+ Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, University of Manchester, Oxford Road, Manchester, United Kingdom, 44 161 276 6880, Martin.Rutter@mft.nhs.uk %K diabetes %K electronic health %K self-management %K complex intervention %D 2022 %7 17.8.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Type 2 Diabetes (T2D) is common, with a prevalence of approximately 7% of the population in the United Kingdom. The quality of T2D care is inconsistent across the United Kingdom, and Greater Manchester (GM) does not currently achieve the National Institute for Health and Care Excellence treatment targets. Barriers to delivery of care include low attendance and poor engagement with local T2D interventions, which tend to consist of programs of education delivered in traditional, face-to-face clinical settings. Thus, a flexible approach to T2D management that is accessible to people from different backgrounds and communities is needed. Diabetes My Way (DMW) is a digital platform that offers a comprehensive self-management and educational program that should be accessible to a wide range of people through mobile apps and websites. Building on evidence generated by a Scotland-wide pilot study, DMW is being rolled out and tested across GM. Objective: The overarching objectives are to assess whether DMW improves outcomes for patients with T2D in the GM area, to explore the acceptability of the DMW intervention to stakeholders, and to assess the cost-effectiveness of the intervention. Methods: A mixed methods approach will be used. We will take a census approach to recruitment in that all eligible participants in GM will be invited to participate. The primary outcomes will be intervention-related changes compared with changes observed in a matched group of controls, and the secondary outcomes will be within-person intervention-related changes. The cost-effectiveness analysis will focus on obtaining reliable estimates of how each intervention affects risk factors such as HbA1c and costs across population groups. Qualitative data will be collected via semistructured interviews and focus groups and organized using template analysis. Results: As of May 10, 2021, a total of 316 participants have been recruited for the quantitative study and have successfully enrolled. A total of 278 participants attempted to register but did not have appropriate permissions set by the general practitioners to gain access to their data. In total, 10 participants have been recruited for the qualitative study (7 practitioners and 3 patients). An extension to recruitment has been granted for the quantitative element of the research, and analysis should be complete by December 2022. Recruitment and analysis for the qualitative study should be complete by December 2021. Conclusions: The findings from this study can be used both to develop the DMW system and improve accessibility and usability in more deprived populations generally, thus improving equity in access to support for T2D self-management. International Registered Report Identifier (IRRID): DERR1-10.2196/26237 %M 35976184 %R 10.2196/26237 %U https://www.researchprotocols.org/2022/8/e26237 %U https://doi.org/10.2196/26237 %U http://www.ncbi.nlm.nih.gov/pubmed/35976184 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e40090 %T Effects of eHealth Interventions on Quality of Life and Psychological Outcomes in Cardiac Surgery Patients: Systematic Review and Meta-analysis %A Ni,Ruping %A Liu,Maobai %A Huang,Shunmin %A Yang,Jing %+ Department of Pharmacy, Fujian Medical University Union Hospital, 29 Xinquan Road, Gulou District, Fuzhou, 350001, China, 86 13706987692, jiangyang@fjmu.edu.cn %K eHealth %K eHealth intervention %K cardiac surgery %K depression %K anxiety %K quality of life %K meta-analysis %K heart disease %K surgery %K heart surgery %K post-operative %K postoperative %K mental health %K home care %K digital health intervention %K digital health %K outcomes %K psychological %K physiological %K physiology %K psychology %K compliance %D 2022 %7 16.8.2022 %9 Review %J J Med Internet Res %G English %X Background: Patients undergoing heart surgery may experience a range of physiological changes, and the postoperative recovery time is long. Patients and their families often have concerns about quality of life (QoL) after discharge. eHealth interventions may improve patient participation, ensure positive and effective health management, improve the quality of at-home care and the patient's quality of life, and reduce rates of depression. Objective: The purpose of this study was to evaluate the effects of eHealth interventions on the physiology, psychology, and compliance of adult patients after cardiac surgery to provide a theoretical basis for clinical practice. Methods: We conducted systematic searches of the following 4 electronic databases: PubMed, Embase, CINAHL, and the Cochrane Central Register of Controlled Trials. Mean (SD) values were used to calculate the pooled effect sizes for all consecutive data, including QoL, anxiety, and depression. Where the same results were obtained using different instruments, we chose the standardized mean difference with a 95% CI to represent the combined effect size; otherwise, the mean difference (MD) with a 95% CI was used. Odds ratios were used to calculate the combined effect size for all dichotomous data. The Cohen Q test for chi-square distribution and an inconsistency index (I2) were used to test for heterogeneity among the studies. We chose a fixed-effects model to estimate the effect size if there was no significant heterogeneity in the data (I2≤50%); otherwise, a random-effects model was used. The quality of the included studies was assessed using the Cochrane risk-of-bias tool for randomized trials (RoB 2). Results: The search identified 3632 papers, of which 19 met the inclusion criteria. In terms of physical outcomes, the score of the control group was lower than that of the intervention group (MD 0.15, 95% CI 0.03-0.27, I2=0%, P=.02). There was no significant difference in the mental outcomes between the intervention and control groups (MD 0.10, 95% CI –0.03 to 0.24, I2=46.4%, P=.14). The control group’s score was lower than that of the intervention group for the depression outcomes (MD –0.53, 95% CI –0.89 to –0.17, I2=57.1%, P=.004). Compliance outcomes improved in most intervention groups. The results of the sensitivity analysis were robust. Nearly half of the included studies (9/19, 47%) had a moderate to high risk of bias. The quality of the evidence was medium to low. Conclusions: eHealth improved the physical component of quality of life and depression after cardiac surgery; however, there was no statistical difference in the mental component of quality of life. The effectiveness of eHealth on patient compliance has been debated. Further high-quality studies on digital health are required. Trial Registration: PROSPERO CRD42022327305; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=327305 %M 35972792 %R 10.2196/40090 %U https://www.jmir.org/2022/8/e40090 %U https://doi.org/10.2196/40090 %U http://www.ncbi.nlm.nih.gov/pubmed/35972792 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 8 %P e40191 %T A Web-Based Intervention to Improve Health Literacy and Obesogenic Behaviors Among Adolescents: Protocol of a Randomized Pilot Feasibility Study for a Parallel Randomized Controlled Trial %A Fleary,Sasha A %+ Department of Community Health and Social Sciences, Graduate School of Public Health and Health Policy, City University of New York, 55 W 125th St, New York, NY, 10027, United States, 1 6463640282, sasha.fleary@sph.cuny.edu %K health literacy %K adolescent %K obesity %K prevention %K diet %K physical activity %K web-based intervention %K eHealth %D 2022 %7 16.8.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Predictive theoretical models suggest that health knowledge works in conjunction with motivation and behavioral skills to influence adolescents’ obesogenic behavior. However, most of the existing adolescent interventions target these variables in isolation. Furthermore, health literacy (HL), a precursor to health knowledge, is necessary for translating health knowledge into behavior and is negatively related to adolescents’ obesity status. However, HL has not been included in obesity interventions targeting adolescents. Objective: This study aims to pilot the feasibility of a 2-armed web-based obesity prevention intervention in school settings and assess the preliminary effectiveness of adding an HL module to an obesity prevention intervention for adolescents. Methods: This web-based pilot feasibility study will take place in the Northeastern United States. Participants will be adolescents (aged 13-16 years) attending school, and recruitment will be conducted through flyers to parents and adolescents in participating classes or advisory groups at the school. The intervention includes 2 arms: an experimental arm that will receive an HL module and 3 obesity prevention modules and a comparison arm that will receive a vaping module and 3 obesity prevention modules. A blinded randomized procedure will be used to allocate classrooms and advisory groups to the experimental and comparison arms. The intervention will be fully web-based. Participants will complete measures of their HL and obesogenic behavior–related health knowledge, motivation, and behaviors at 3 time points (baseline, 1 month after the intervention, and 3 months after the intervention) via web-based surveys. The primary outcomes will be the measures of study feasibility (recruitment, retention, completion, and treatment fidelity rates). Secondary outcomes will be preliminary efficacy, as measured by logistic and linear regressions and calculation of effect sizes. Descriptive statistics will be calculated for all measures at each time point. Results: This study was approved by the City University of New York Institutional Review Board in August 2020. As of June 2022, the web-based intervention design is complete and ready for use. Recruitment, data collection, and intervention implementation are scheduled to begin in September 2022. These results are expected to be published in 2023. Conclusions: This study’s feasibility findings will inform changes to the intervention content and randomized controlled trial design. The study’s efficacy findings will inform the sample size for the full-scale randomized controlled trial and the preliminary utility of the intervention. Trial Registration: ClinicalTrials.gov NCT04252677; https://clinicaltrials.gov/ct2/show/NCT04252677 International Registered Report Identifier (IRRID): PRR1-10.2196/40191 %M 35972787 %R 10.2196/40191 %U https://www.researchprotocols.org/2022/8/e40191 %U https://doi.org/10.2196/40191 %U http://www.ncbi.nlm.nih.gov/pubmed/35972787 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e33696 %T Analyzing the Impact of Mobile App Engagement on Mental Health Outcomes: Secondary Analysis of the Unwinding Anxiety Program %A Nardi,William %A Roy,Alexandra %A Dunsiger,Shira %A Brewer,Judson %+ Department of Behavioral and Social Sciences, Brown University, 121 South Main Street, Providence, RI, 02903, United States, 1 8609649144, william_nardi@brown.edu %K anxiety %K worry %K engagement %K mobile app %K mental health %K mobile phone %D 2022 %7 15.8.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: App-based interventions provide a promising avenue for mitigating the burden on mental health services by complimenting therapist-led treatments for anxiety. However, it remains unclear how specific systems’ use of app features may be associated with changes in mental health outcomes (eg, anxiety and worry). Objective: This study was a secondary analysis of engagement data from a stage 1 randomized controlled trial testing the impact of the Unwinding Anxiety mobile app among adults with generalized anxiety disorder. The aims of this study were 2-fold: to investigate whether higher microengagement with the primary intervention feature (ie, educational modules) is associated with positive changes in mental health outcomes at 2 months (ie, anxiety, worry, interoceptive awareness, and emotional reactivity) and to investigate whether the use of adjunctive app features is also associated with changes in mental health outcomes. Methods: We analyzed the intervention group during the stage 1 trial of the Unwinding Anxiety mobile app. The total use of specific mobile app features and the use specific to each feature were calculated. We used multivariate linear models with a priori significance of α=.05 to investigate the impact of cumulative app use on anxiety, worry, interoceptive awareness, and emotional regulation at 2 months, controlling for baseline scores, age, and education level in all models. Significant relationships between system use metrics and baseline participant characteristics were assessed for differences in use groupings using between-group testing (ie, 2-tailed t tests for continuous data and chi-square analyses for categorical data). Results: The sample was primarily female (25/27, 93%), and the average age was 42.9 (SD 15.6) years. Educational module completion, the central intervention component, averaged 20.2 (SD 11.4) modules out of 32 for the total sample. Multivariate models revealed that completing >75% of the program was associated with an average 22.6-point increase in interoceptive awareness (b=22.6; SE 8.32; P=.01; 95% CI 5.3-39.8) and an 11.6-point decrease in worry (b=−11.6; SE 4.12; P=.01; 95% CI −20.2 to −3.1). In addition, a single log unit change in the total number of meditations was associated with a 0.62-point reduction in the Generalized Anxiety Disorder-7 scale scores (b=0.62; SE 0.27; P=.005; 95% CI −1.2 to −0.6), whereas a single log unit use of the stress meter was associated with an average of a 0.5-point increase in emotional regulation scores (Five Facet Mindfulness Questionnaire; b=0.5; SE 0.21; P=.03; 95% CI 0.1-0.9). Conclusions: This study offers a clearer understanding of the impact of engagement with app features on broader engagement with the health outcomes of interest. This study highlights the importance of comprehensive investigations of engagement during the development of evidence-based mobile apps. %M 35969440 %R 10.2196/33696 %U https://www.jmir.org/2022/8/e33696 %U https://doi.org/10.2196/33696 %U http://www.ncbi.nlm.nih.gov/pubmed/35969440 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 8 %P e38934 %T Clinical Targets and Attitudes Toward Implementing Digital Health Tools for Remote Measurement in Treatment for Depression: Focus Groups With Patients and Clinicians %A de Angel,Valeria %A Lewis,Serena %A White,Katie M %A Matcham,Faith %A Hotopf,Matthew %+ Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, E3.08, 3rd floor East Wing, 16 De Crespigny Park, London, SE5 8AF , United Kingdom, 44 7415838882, valeria.de_angel@kcl.ac.uk %K depression %K digital health tools %K implementation %K qualitative %K wearable devices %K smartphone %K passive sensing %K sensor data %K mobile health %K mHealth %K mood disorders %K digital phenotyping %K mobile phone %D 2022 %7 15.8.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Remote measurement technologies, such as smartphones and wearable devices, can improve treatment outcomes for depression through enhanced illness characterization and monitoring. However, little is known about digital outcomes that are clinically meaningful to patients and clinicians. Moreover, if these technologies are to be successfully implemented within treatment, stakeholders’ views on the barriers to and facilitators of their implementation in treatment must be considered. Objective: This study aims to identify clinically meaningful targets for digital health research in depression and explore attitudes toward their implementation in psychological services. Methods: A grounded theory approach was used on qualitative data from 3 focus groups of patients with a current diagnosis of depression and clinicians with >6 months of experience with delivering psychotherapy (N=22). Results: Emerging themes on clinical targets fell into the following two main categories: promoters and markers of change. The former are behaviors that participants engage in to promote mental health, and the latter signal a change in mood. These themes were further subdivided into external changes (changes in behavior) or internal changes (changes in thoughts or feelings) and mapped with potential digital sensors. The following six implementation acceptability themes emerged: technology-related factors, information and data management, emotional support, cognitive support, increased self-awareness, and clinical utility. Conclusions: The promoters versus markers of change differentiation have implications for a causal model of digital phenotyping in depression, which this paper presents. Internal versus external subdivisions are helpful in determining which factors are more susceptible to being measured by using active versus passive methods. The implications for implementation within psychotherapy are discussed with regard to treatment effectiveness, service provision, and patient and clinician experience. %M 35969448 %R 10.2196/38934 %U https://mental.jmir.org/2022/8/e38934 %U https://doi.org/10.2196/38934 %U http://www.ncbi.nlm.nih.gov/pubmed/35969448 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 8 %P e35881 %T A Group Videoconferencing Intervention (C@nnected) to Improve Maternal Sensitivity: Protocol for a Randomized Feasibility Trial %A Binda,Victoria %A Olhaberry,Marcia %A Castañon,Carla %A Abarca,Constanza %A Caamaño,Catalina %+ Deparment of Family Medicine, Medicine Faculty, Pontificia Universidad Católica de Chile, Av. Vicuña Mackenna 4860, Macul, Santiago, 7820436, Chile, 56 223548535, vbinda@uc.cl %K maternal sensitivity %K group intervention %K primary care %K eHealth %K responsive caregiving %K videoconferencing %K Early childhood %K caregiver %K eHealth intervention %K health intervention %K parenting %K children %K peer-support %D 2022 %7 15.8.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Early childhood development is highly dependent on the sensitive care provided by caregivers, and interventions focused on supporting parents to improve their sensitivity have shown to be effective. The COVID-19 pandemic has had a significant impact on mental health, with pregnant women and mothers of infants being an especially vulnerable group and maternal sensitivity particularly affected. However, access to face-to-face interventions is restricted; thus, it is important to have remote interventions to support this group of mothers. Objective: The objective of this study is to evaluate the feasibility and acceptability of C@nnected, a group videoconferencing intervention to improve maternal sensitivity aimed at mother-infant dyads attending primary health care centers in vulnerable areas of Santiago, Chile. Methods: This is a randomized feasibility single-masked (outcome assessor) study with a qualitative component. It will involve a block randomization procedure to generate a 3:2 allocation ratio (with more people allocated to the intervention arm). The intervention consists of 4 group videoconferencing sessions adapted from a face-to-face intervention with proven effectiveness. The control group will receive treatment as usual, along with educational brochures. The feasibility and acceptability of this study will be quantitatively and qualitatively assessed. Changes in clinical outcomes relating to maternal sensitivity, depressive symptoms, postpartum maternal attachment, and infant socioemotional development will also be evaluated. Results: We finished adapting the face-to-face intervention to the videoconferencing format in July 2021. The study began recruitment in August 2021, and enrollment is expected to end in August 2022, with final study results expected in December 2022. Conclusions: This study will contribute evidence for the use of eHealth interventions to promote maternal sensitivity. It will also inform the design and implementation of a future randomized clinical trial. Trial Registration: ClinicalTrials.gov NCT04904861; https://clinicaltrials.gov/ct2/show/NCT04904861 International Registered Report Identifier (IRRID): DERR1-10.2196/35881 %M 35969451 %R 10.2196/35881 %U https://www.researchprotocols.org/2022/8/e35881 %U https://doi.org/10.2196/35881 %U http://www.ncbi.nlm.nih.gov/pubmed/35969451 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e37973 %T The Effects of Internet-Based Storytelling Programs (Amazing Adventure Against Stigma) in Reducing Mental Illness Stigma With Mediation by Interactivity and Stigma Content: Randomized Controlled Trial %A Fong,Tiffany H C %A Mak,Winnie W S %+ Department of Psychology, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, Hong Kong, 852 39436577, wwsmak@psy.cuhk.edu.hk %K mental illness stigma %K internet-based %K interactivity %K storytelling %K social distance %K microaggression %D 2022 %7 12.8.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Mental illness stigma has been a global concern, owing to its adverse effects on the recovery of people with mental illness, and may delay help-seeking for mental health because of the concern of being stigmatized. With technological advancement, internet-based interventions for the reduction of mental illness stigma have been developed, and these effects have been promising. Objective: This study aimed to examine the differential effects of internet-based storytelling programs, which varied in the levels of interactivity and stigma content, in reducing mental illness stigma. Methods: Using an experimental design, this study compared the effects of 4 storytelling websites that varied in the levels of interactivity and stigma content. Specifically, the conditions included an interactive website with stigma-related content (combo condition), a noninteractive website with stigma-related content (stigma condition), an interactive website without stigma-related content (interact condition), and a noninteractive website without stigma-related content (control condition). Participants were recruited via mass emails to all students and staff of a public university and via social networking sites. Eligible participants were randomized into the following four conditions: combo (n=67), stigma (n=65), interact (n=64), or control (n=67). The participants of each group viewed the respective web pages at their own pace. Public stigma, microaggression, and social distance were measured on the web before the experiment, after the experiment, and at the 1-week follow-up. Perceived autonomy and immersiveness, as mediators, were assessed after the experiment. Results: Both the combo (n=66) and stigma (n=65) conditions were effective in reducing public stigma and microaggression toward people with mental illness after the experiment and at the 1-week follow-up. However, none of the conditions had significant time×condition effects in reducing the social distance from people with mental illness. The interact condition (n=64) significantly reduced public stigma after the experiment (P=.02) but not at the 1-week follow-up (P=.22). The control condition (n=67) did not significantly reduce all outcomes associated with mental illness stigma. Perceived autonomy was found to mediate the effect of public stigma (P=.56), and immersiveness mediated the effect of microaggression (P=.99). Conclusions: Internet-based storytelling programs with stigma-related content and interactivity elicited the largest effects in stigma reduction, including reductions in public stigma and microaggression, although only its difference with internet-based storytelling programs with stigma-related content was not statistically significant. In other words, although interactivity could strengthen the stigma reduction effect, stigma-related content was more critical than interactivity in reducing stigma. Future stigma reduction efforts should prioritize the production of effective stigma content on their web pages, followed by considering the value of incorporating interactivity in future internet-based storytelling programs. Trial Registration: ClinicalTrials.gov NCT05333848; https://clinicaltrials.gov/ct2/show/NCT05333848 %M 35969460 %R 10.2196/37973 %U https://www.jmir.org/2022/8/e37973 %U https://doi.org/10.2196/37973 %U http://www.ncbi.nlm.nih.gov/pubmed/35969460 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e37936 %T Effect of a Reminder System on Pre-exposure Prophylaxis Adherence in Men Who Have Sex With Men: Prospective Cohort Study Based on WeChat Intervention %A Lin,Bing %A Liu,Jiaxiu %A He,Wei %A Pan,Haiying %A Ma,Yingjie %A Zhong,Xiaoni %+ School of Public Health and Management, Chongqing Medical University, No.1 Medical College Road, Yuzhong District, Chongqing, 400042, China, 86 13308368059, zhongxiaoni@cqmu.edu.cn %K pre-exposure prophylaxis (PrEP) %K adherence %K reminder system %K men who have sex with men (MSM) %K WeChat %K oral PrEP %K HIV prevention %K MSM %K reminder %K message %D 2022 %7 11.8.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The efficacy of pre-exposure prophylaxis (PrEP) is highly dependent on adherence, and one of the main reasons for poor adherence is forgetfulness. Therefore, it is important to explore how to remind users to take their medicine on time. Objective: This study aims to explore the effect of a reminder system on PrEP adherence in men who have sex with men (MSM) to improve adherence. The main function of the reminder system based on the WeChat social media app is to send daily messages to PrEP users reminding them to take their medicine. Methods: An open-label, multicenter, prospective cohort study of PrEP in HIV-negative MSM was conducted from November 2019 to June 2021. Study participants who met the criteria were randomly divided into 2 groups: no-reminder group and reminder group. Both groups received daily oral PrEP with follow-up every 3 months. Adherence was measured on the basis of self-report and was defined as the percentage of medications taken on time. Participants in the reminder group scanned a WeChat QR code and received a reminder message every day. Participants in the no-reminder group took daily oral medicines without reminders. The longitudinal trajectories of adherence for both groups were displayed to compare the variability in adherence at each time point. The association between the changes in adherence (no change, improvement, decline) at each time point and the use of the reminder system was analyzed by multinomial logistic regression models to further explore the effectiveness of the system. Results: A total of 716 MSM were included in the analysis, that is, 372 MSM in the no-reminder group and 344 MSM in the reminder group. Adherence in the no-reminder group fluctuated between 0.75 and 0.80 and that in the reminder group gradually increased over time from 0.76 to 0.88. Adherence at each time point was not statistically different between the 2 groups. Further analysis showed that an improvement in adherence in the early stage was associated with the use of the reminder system (odds ratio [OR] 1.65, 95% CI 1.01-2.70; P=.04). An improvement in average adherence compared to initial adherence was positively associated with the use of the reminder system (OR 1.82, 95% CI 1.10-3.01; P=.02). Conclusions: The effect of the reminder system on PrEP adherence in MSM was more significant in the early stage, which is related to the increased motivation of users and the development of medicine-taking habits. The reminder system is potentially effective for early-stage medicine management, encouraging users to develop healthy medicine-taking habits and to increase their adherence. Trial Registration: Chinese Clinical Trial ChiCTR190026414; http://www.chictr.org.cn/showproj.aspx?proj=35077 %M 35969436 %R 10.2196/37936 %U https://www.jmir.org/2022/8/e37936 %U https://doi.org/10.2196/37936 %U http://www.ncbi.nlm.nih.gov/pubmed/35969436 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 8 %P e39129 %T The Effectiveness of Web-Based Psychotherapy to Treat and Prevent Burnout: Controlled Trial %A Michelsen,Clive %A Kjellgren,Anette %+ Science College, University of Karlstad, Bjuörgatan 32, Malmö, 21124, Sweden, 46 704065696, clive.michelsen@scienscollege.se %K risk for burnout %K effectivity of web-based therapy %K Proactive Occupational Health %K presenteeism %K work-related stress %D 2022 %7 11.8.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Burnout is a hidden productivity killer in organizations. Finding a solution to efficiently measure and proactively prevent or rehabilitate employees with burnout is a challenge. To meet this unabated demand, companies and caregivers can focus on proactive measures to prevent “Burnout as an Occupational Phenomenon.” Objective: We aimed to address effectiveness, reliability, and validity of the empowerment for participation (EFP) batch of assessments to measure burnout risk in relation to the efficacy of web-based interventions using cognitive behavioral therapy (CBT) and floating to improve mental health and well-being. We introduced three risk assessments: risk for burnout, risk of anxiety, and risk for depression. Methods: We used an interventional, empirical, and parallel design using raw EFP psychometric data to measure the effectiveness of web-based therapy to reduce the risk of burnout between a control group and web-based therapy group. A total of 50 participants were selected. The rehabilitation and control groups consisted of 25 normally distributed employees each. The rehabilitation group received therapy, whereas the control group had not yet received any form of therapy. IBM SPSS was used to analyze the data collected, and a repeated measures ANOVA, an analysis of covariance, a discriminant analysis, and a construct validity analysis were used to test for reliability and validity. The group was selected from a list of employees within the My-E-Health ecosystem who showed a moderate or high risk for burnout. All assessments and mixed-method CBT were web-based, and floating was conducted at designated locations. The complete EFP assessment was integrated into a digital ecosystem designed for this purpose and therapy, offering a secure and encrypted ecosystem. Results: There was a statistically significant difference between pre- and postassessment scores for burnout. The reliability of the burnout measure was good (Cronbach α=.858; mean 1.826, SD 3.008; Cohen d=0.607; P<.001) with a high validity of 0.9420. A paired samples 2-tailed test showed a good t score of 4.292 and P<.001, with a good effect size, Cohen d=0.607. Web-based therapy reduced the risk for burnout in participants compared with the control group. Tests of between-subject effects show F=16.964, a significant difference between the control group and the web-based therapy group: P<.001, with movement between the group variables of 0.261 or 26.1% for the dependent variable. Conclusions: This study suggests good reliability and validity of using web-based interventional mixed methods CBT to reduce the risk of burnout. The EFP batch of web-based assessments could reliably identify morbidity risk levels and successfully measure clinical interventions and rehabilitation with consistently reliable results to serve as both a diagnostic and therapeutic tool worthy of major research in the future. Trial Registration: ClinicalTrials.gov NCT05343208; https://clinicaltrials.gov/ct2/show/NCT05343208 %M 35802001 %R 10.2196/39129 %U https://formative.jmir.org/2022/8/e39129 %U https://doi.org/10.2196/39129 %U http://www.ncbi.nlm.nih.gov/pubmed/35802001 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 8 %P e36969 %T Development of a Dynamically Tailored mHealth Intervention (What Do You Drink) to Reduce Excessive Drinking Among Dutch Lower-Educated Students: User-Centered Design Approach %A van Keulen,Hilde %A Voogt,Carmen %A Kleinjan,Marloes %A Kramer,Jeannet %A Andree,Rosa %A van Empelen,Pepijn %+ Department of Child Health, TNO (Netherlands Organization for Applied Scientific Research), Schipholweg 77-79, Leiden, 2316 ZL, Netherlands, 31 652803631, hilde.vankeulen@tno.nl %K alcohol consumption %K excessive drinking %K lower-educated students %K adolescents %K young adults %K dynamic tailoring %K mobile health intervention %K intervention mapping %K health promotion %D 2022 %7 11.8.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The high prevalence and adverse consequences of excessive drinking among lower-educated adolescents and young adults are public concerns in the Netherlands. Evidence-based alcohol prevention programs targeting adolescents and young adults with a low educational background are sparse. Objective: This study aimed to describe the planned process for the theory- and evidence-based development, implementation, and evaluation of a dynamically tailored mobile alcohol intervention, entitled What Do You Drink (WDYD), aimed at lower-educated students from secondary vocational education and training (Middelbaar Beroepsonderwijs in Dutch). Methods: We used intervention mapping as the framework for the systematic development of WDYD. It consists of the following six steps: assessing needs (step 1), formulating intervention objectives (step 2), translating theoretical methods into practical applications (step 3), integrating these into a coherent program (step 4), anticipating future implementation and adoption (step 5), and developing an evaluation plan (step 6). Results: Reducing excessive drinking among Dutch lower-educated students aged 16 to 24 years was defined as the desired behavioral outcome and subdivided into the following five program objectives: make the decision to reduce drinking, set realistic drinking goals, use effective strategies to achieve drinking goals, monitor own drinking behavior, and evaluate own drinking behavior and adjust goals. Risk awareness, motivation, social norms, and self-efficacy were identified as the most important and changeable individual determinants related to excessive drinking and, therefore, were incorporated into WDYD. Dynamic tailoring was selected as the basic intervention method for changing these determinants. A user-centered design strategy was used to enhance the fit of the intervention to the needs of students. The intervention was developed in 4 iterations, and the prototypes were subsequently tested with the students and refined. This resulted in a completely automated, standalone native app in which students received dynamically tailored feedback regarding their alcohol use and goal achievement via multiple sessions within 17 weeks based on diary data assessing their alcohol consumption, motivation, confidence, and mood. A randomized controlled trial with ecological momentary assessments will be used to examine the effects, use, and acceptability of the intervention. Conclusions: The use of intervention mapping led to the development of an innovative, evidence-based intervention to reduce excessive alcohol consumption among lower-educated Dutch adolescents and young adults. Developing an intervention based on theory and empirical evidence enables researchers and program planners to identify and retain effective intervention elements and to translate the intervention to new populations and settings. This is important, as black boxes, or poorly described interventions, have long been a criticism of the eHealth field, and effective intervention elements across mobile health alcohol interventions are still largely unknown. Trial Registration: Netherlands Trial Registry NTR6619; https://trialsearch.who.int/Trial2.aspx?TrialID=NTR6619 %M 35969428 %R 10.2196/36969 %U https://formative.jmir.org/2022/8/e36969 %U https://doi.org/10.2196/36969 %U http://www.ncbi.nlm.nih.gov/pubmed/35969428 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e36620 %T Understanding Engagement in Digital Mental Health and Well-being Programs for Women in the Perinatal Period: Systematic Review Without Meta-analysis %A Davis,Jacqueline A %A Ohan,Jeneva L %A Gibson,Lisa Y %A Prescott,Susan L %A Finlay-Jones,Amy L %+ Telethon Kids Institute, 15 Hospital Avenue, Nedlands, 6009, Australia, 61 478173989, jackie.davis@telethonkids.org.au %K digital interventions %K perinatal %K mental health %K well-being %K logic model %K systematic review %K mobile phone %D 2022 %7 9.8.2022 %9 Review %J J Med Internet Res %G English %X Background: Pregnancy and the postnatal period can be a time of increased psychological distress, which can be detrimental to both the mother and the developing child. Digital interventions are cost-effective and accessible tools to support positive mental health in women during the perinatal period. Although studies report efficacy, a key concern regarding web-based interventions is the lack of engagement leading to drop out, lack of participation, or reduced potential intervention benefits. Objective: This systematic review aimed to understand the reporting and levels of engagement in studies of digital psychological mental health or well-being interventions administered during the perinatal period. Specific objectives were to understand how studies report engagement across 4 domains specified in the Connect, Attend, Participate, and Enact (CAPE) model, make recommendations on best practices to report engagement in digital mental health interventions (DMHIs), and understand levels of engagement in intervention studies in this area. To maximize the utility of this systematic review, we intended to develop practical tools for public health use: to develop a logic model to reference the theory of change, evaluate the studies using the CAPE framework, and develop a guide for future data collection to enable consistent reporting in digital interventions. Methods: This systematic review used the Cochrane Synthesis Without Meta-analysis reporting guidelines. This study aimed to identify studies reporting DMHIs delivered during the perinatal period in women with subclinical mood symptoms. A systematic database search was used to identify relevant papers using the Ovid Platform for MEDLINE, PsycINFO, EMBASE, Scopus, Web of Science, and Medical Subject Headings on Demand for all English-language articles published in the past 10 years. Results: Searches generated a database of 3473 potentially eligible studies, with a final selection of 16 (0.46%) studies grouped by study design. Participant engagement was evaluated using the CAPE framework and comparable variables were described. All studies reported at least one engagement metric. However, the measures used were inconsistent, which may have contributed to the wide-ranging results. There was insufficient reporting for enactment (ie, participants’ real-world use of intervention skills), with only 38% (6/16) of studies clearly recording longer-term practice through postintervention interviews. The logic model proposes ways of conceptualizing and reporting engagement details in DMHIs more consistently in the future. Conclusions: The perinatal period is the optimal time to intervene with strength-based digital tools to build positive mental health. Despite the growing number of studies on digital interventions, few robustly explore engagement, and there is limited evidence of long-term skill use beyond the intervention period. Our results indicate variability in the reporting of both short- and long-term participant engagement behaviors, and we recommend the adoption of standardized reporting metrics in future digital interventions. Trial Registration: PROSPERO CRD42020162283; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=162283 %M 35943773 %R 10.2196/36620 %U https://www.jmir.org/2022/8/e36620 %U https://doi.org/10.2196/36620 %U http://www.ncbi.nlm.nih.gov/pubmed/35943773 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e35283 %T Technology-Delivered Adaptations of Motivational Interviewing for the Prevention and Management of Chronic Diseases: Scoping Review %A Pedamallu,Havisha %A Ehrhardt,Matthew J %A Maki,Julia %A Carcone,April Idalski %A Hudson,Melissa M %A Waters,Erika A %+ Division of Public Health Sciences, Department of Surgery, Washington University in St Louis, School of Medicine, 600 S Euclid Ave, Campus Box 8100, St Louis, MO, 63110, United States, 1 314 747 5705, waterse@wustl.edu %K motivational interviewing %K technology %K telehealth %K health behavior %K chronic disease %K socioeconomic factors %K health promotion %K disease management %K primary prevention %K secondary prevention %K minority health %D 2022 %7 9.8.2022 %9 Review %J J Med Internet Res %G English %X Background: Motivational interviewing (MI) can increase health-promoting behaviors and decrease health-damaging behaviors. However, MI is often resource intensive, precluding its use with people with limited financial or time resources. Mobile health–based versions of MI interventions or technology-delivered adaptations of MI (TAMIs) might increase reach. Objective: We aimed to understand the characteristics of existing TAMIs. We were particularly interested in the inclusion of people from marginalized sociodemographic groups, whether the TAMI addressed sociocontextual factors, and how behavioral and health outcomes were reported. Methods: We employed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for scoping reviews to conduct our scoping review. We searched PubMed, CINAHL, and PsycInfo from January 1, 1996, to April 6, 2022, to identify studies that described interventions incorporating MI into a mobile or electronic health platform. For inclusion, the study was required to (1) describe methods/outcomes of an MI intervention, (2) feature an intervention delivered automatically via a mobile or electronic health platform, and (3) report a behavioral or health outcome. The exclusion criteria were (1) publication in a language other than English and (2) description of only in-person intervention delivery (ie, no TAMI). We charted results using Excel (Microsoft Corp). Results: Thirty-four studies reported the use of TAMIs. Sample sizes ranged from 10 to 2069 participants aged 13 to 70 years. Most studies (n=27) directed interventions toward individuals engaging in behaviors that increased chronic disease risk. Most studies (n=22) oversampled individuals from marginalized sociodemographic groups, but few (n=3) were designed specifically with marginalized groups in mind. TAMIs used text messaging (n=8), web-based intervention (n=22), app + text messaging (n=1), and web-based intervention + text messaging (n=3) as delivery platforms. Of the 34 studies, 30 (88%) were randomized controlled trials reporting behavioral and health-related outcomes, 23 of which reported statistically significant improvements in targeted behaviors with TAMI use. TAMIs improved targeted health behaviors in the remaining 4 studies. Moreover, 11 (32%) studies assessed TAMI feasibility, acceptability, or satisfaction, and all rated TAMIs highly in this regard. Among 20 studies with a disproportionately high number of people from marginalized racial or ethnic groups compared with the general US population, 16 (80%) reported increased engagement in health behaviors or better health outcomes. However, no TAMIs included elements that addressed sociocontextual influences on behavior or health outcomes. Conclusions: Our findings suggest that TAMIs may improve some health promotion and disease management behaviors. However, few TAMIs were designed specifically for people from marginalized sociodemographic groups, and none included elements to help address sociocontextual challenges. Research is needed to determine how TAMIs affect individual health outcomes and how to incorporate elements that address sociocontextual factors, and to identify the best practices for implementing TAMIs into clinical practice. %M 35943775 %R 10.2196/35283 %U https://www.jmir.org/2022/8/e35283 %U https://doi.org/10.2196/35283 %U http://www.ncbi.nlm.nih.gov/pubmed/35943775 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 8 %P e39516 %T The Effect of Mental Health App Customization on Depressive Symptoms in College Students: Randomized Controlled Trial %A Six,Stephanie G %A Byrne,Kaileigh A %A Aly,Heba %A Harris,Maggie W %+ Department of Psychology, Clemson University, 418 Brackett Hall, Clemson University, Clemson, SC, 29634-0001, United States, 1 864 656 3935, kaileib@clemson.edu %K depression %K mental health apps %K customization %K personalization %K cognitive behavioral therapy %K avatars %K mobile phone %D 2022 %7 9.8.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Mental health apps have shown promise in improving mental health symptoms, including depressive symptoms. However, limited research has been aimed at understanding how specific app features and designs can optimize the therapeutic benefits and adherence to such mental health apps. Objective: The primary purpose of this study is to investigate the effect of avatar customization on depressive symptoms and adherence to use a novel cognitive behavioral therapy (CBT)–based mental health app. The secondary aim is to examine whether specific app features, including journaling, mood tracking, and reminders, affect the usability of the mental health app. Methods: College students were recruited from a university study recruitment pool website and via flyer advertisements throughout campus. A total of 94 participants completed a randomized controlled trial in which they were randomized to either customization or no customization version of the app. Customization involved personalizing a virtual avatar and a travel vehicle to one’s own preferences and use of one’s name throughout the app. Participants completed a 14-day trial using a novel CBT-based mental health app called AirHeart. Self-report scores for depressive symptoms, anxiety, and stress were measured at baseline and after the intervention. Postintervention survey measures also included usability and avatar identification questionnaires. Results: Of the 94 enrolled participants, 83 (88%) completed the intervention and postintervention assessments. AirHeart app use significantly reduced symptoms of depression (P=.006) from baseline to the end of the 2-week intervention period for all participants, regardless of the customization condition. However, no differences in depressive symptoms (P=.17) or adherence (P=.80) were observed between the customization (39/83, 47%) and no customization (44/83, 53%) conditions. The frequency of journaling, usefulness of mood tracking, and helpfulness of reminders were not associated with changes in depressive symptoms or adherence (P>.05). Exploratory analyses showed that there were 3 moderate positive correlations between avatar identification and depressive symptoms (identification: r=−0.312, P=.02; connection: r=−0.305, P=.02; and lack of relatability: r=0.338, P=.01). Conclusions: These results indicate that CBT mental health apps, such as AirHeart, have the potential to reduce depressive symptoms over a short intervention period. The randomized controlled trial results demonstrated that customization of app features, such as avatars, does not further reduce depressive symptoms over and above the CBT modules and standard app features, including journal, reminders, and mood tracking. However, further research elucidating the relationship between virtual avatar identification and mental health systems is needed as society becomes increasingly more digitized. These findings have potential implications for improving the optimization of mental health app designs. Trial Registration: Open Science Framework t28gm; https://osf.io/t28gm %M 35943788 %R 10.2196/39516 %U https://mental.jmir.org/2022/8/e39516 %U https://doi.org/10.2196/39516 %U http://www.ncbi.nlm.nih.gov/pubmed/35943788 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 8 %P e36430 %T A Web-Based Application for Personalized Ecological Momentary Assessment in Psychiatric Care: User-Centered Development of the PETRA Application %A Bos,Fionneke M %A von Klipstein,Lino %A Emerencia,Ando C %A Veermans,Erwin %A Verhage,Tom %A Snippe,Evelien %A Doornbos,Bennard %A Hadders-Prins,Grietje %A Wichers,Marieke %A Riese,Harriëtte %+ Rob Giel Research Center, Department of Psychiatry, University Medical Center Groningen, University of Groningen, Hanzeplein 1, Groningen, 9700 RB, Netherlands, 31 50 361 4860, f.m.bos01@umcg.nl %K eHealth %K clinical implementation %K ecological momentary assessment %K experience sampling method %K smartphone %K mobile health %K mHealth %K personalized diaries %K personalized psychiatry %K client-tailored %K cocreation %K shared decision-making %K mobile phone %D 2022 %7 9.8.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Smartphone self-monitoring of mood, symptoms, and contextual factors through ecological momentary assessment (EMA) provides insights into the daily lives of people undergoing psychiatric treatment. Therefore, EMA has the potential to improve their care. To integrate EMA into treatment, a clinical tool that helps clients and clinicians create personalized EMA diaries and interpret the gathered data is needed. Objective: This study aimed to develop a web-based application for personalized EMA in specialized psychiatric care in close collaboration with all stakeholders (ie, clients, clinicians, researchers, and software developers). Methods: The participants were 52 clients with mood, anxiety, and psychotic disorders and 45 clinicians (psychiatrists, psychologists, and psychiatric nurses). We engaged them in interviews, focus groups, and usability sessions to determine the requirements for an EMA web application and repeatedly obtained feedback on iteratively improved high-fidelity EMA web application prototypes. We used human-centered design principles to determine important requirements for the web application and designed high-fidelity prototypes that were continuously re-evaluated and adapted. Results: The iterative development process resulted in Personalized Treatment by Real-time Assessment (PETRA), which is a scientifically grounded web application for the integration of personalized EMA in Dutch clinical care. PETRA includes a decision aid to support clients and clinicians with constructing personalized EMA diaries, an EMA diary item repository, an SMS text message–based diary delivery system, and a feedback module for visualizing the gathered EMA data. PETRA is integrated into electronic health record systems to ensure ease of use and sustainable integration in clinical care and adheres to privacy regulations. Conclusions: PETRA was built to fulfill the needs of clients and clinicians for a user-friendly and personalized EMA tool embedded in routine psychiatric care. PETRA is unique in this codevelopment process, its extensive but user-friendly personalization options, its integration into electronic health record systems, its transdiagnostic focus, and its strong scientific foundation in the design of EMA diaries and feedback. The clinical effectiveness of integrating personalized diaries via PETRA into care requires further research. As such, PETRA paves the way for a systematic investigation of the utility of personalized EMA for routine mental health care. %M 35943762 %R 10.2196/36430 %U https://mental.jmir.org/2022/8/e36430 %U https://doi.org/10.2196/36430 %U http://www.ncbi.nlm.nih.gov/pubmed/35943762 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 5 %N 3 %P e36515 %T Mitigating Feelings of Loneliness and Depression by Means of Web-Based or Print-Based Physical Activity Interventions: Pooled Analysis of 2 Community-Based Intervention Trials %A Lippke,Sonia %A Ratz,Tiara %A Keller,Franziska Maria %A Juljugin,Dennis %A Peters,Manuela %A Pischke,Claudia %A Voelcker-Rehage,Claudia %+ Psychology & Methods, Jacobs University Bremen, Campus Ring 1, Bremen, 28759, Germany, 49 421200 ext 4730, s.lippke@jacobs-university.de %K physical activity %K older adults %K intervention %K loneliness %K depression %K eHealth %K mobile health %K mHealth %D 2022 %7 9.8.2022 %9 Original Paper %J JMIR Aging %G English %X Background: Physical activity (PA) is associated with benefits, such as fewer depressive symptoms and loneliness. Web- and print-based PA interventions can help older individuals accordingly. Objective: We aimed to test the following research questions: Do PA interventions delivered in a web- or print-based mode improve self-reported PA stage of change, social-cognitive determinants of PA, loneliness, and symptoms of depression? Is subjective age a mediator and stage of change a moderator of this effect? Methods: Overall, 831 adults aged ≥60 years were recruited and either allocated to a print-based or web-based intervention group or assigned to a wait-list control group (WLCG) in 2 community-based PA intervention trials over 10 weeks. Missing value imputation using an expectation-maximization algorithm was applied. Frequency analyses, multivariate analyses of variance, and moderated mediation analyses were conducted. Results: The web-based intervention outperformed (47/59, 80% of initially inactive individuals being adopters, and 396/411, 96.4% of initially active individuals being maintainers of the recommended PA behavior) the print-based intervention (20/25, 80% of adopters, and 63/69, 91% of maintainers) and the WLCG (5/7, 71% of adopters; 141/150, 94% of maintainers). The pattern regarding adopters was statistically significant (web vs print Z=–1.94; P=.02; WLCG vs web Z=3.8367; P=.01). The pattern was replicated with stages (χ24=79.1; P<.001; contingency coefficient 0.314; P<.001); in the WLCG, 40.1% (63/157) of the study participants moved to or remained in action stage. This number was higher in the groups receiving web-based (357/470, 76%) or print-based interventions (64/94, 68.1%). A significant difference was observed favoring the 2 intervention groups over and above the WLCG (F19, 701=4.778; P<.001; η2=0.098) and a significant interaction of time and group (F19, 701=2.778; P<.001; η2=0.070) for predictors of behavior. The effects of the interventions on subjective age, loneliness, and depression revealed that both between-group effects (F3, 717=8.668; P<.001; η2=0.018) and the interaction between group and time were significant (F3, 717=6.101; P<.001; η2=0.025). In a moderated mediation model, both interventions had a significant direct effect on depression in comparison with the WLCG (web-based: c′ path −0.86, 95% CI −1.58 to −0.13, SE 0.38; print-based: c′ path −1.96, 95% CI −2.99 to −0.92, SE 0.53). Furthermore, subjective age was positively related to depression (b path 0.14, 95% CI 0.05-0.23; SE 0.05). An indirect effect of the intervention on depression via subjective age was only present for participants who were in actor stage and received the web-based intervention (ab path −0.14, 95% CI −0.34 to −0.01; SE 0.09). Conclusions: Web-based interventions appear to be as effective as print-based interventions. Both modes might help older individuals remain or become active and experience fewer depression symptoms, especially if they feel younger. Trial Registration: German Registry of Clinical Trials DRKS00010052 (PROMOTE 1); https://tinyurl.com/nnzarpsu and DRKS00016073 (PROMOTE 2); https://tinyurl.com/4fhcvkwy International Registered Report Identifier (IRRID): RR2-10.2196/15168 %M 35943790 %R 10.2196/36515 %U https://aging.jmir.org/2022/3/e36515 %U https://doi.org/10.2196/36515 %U http://www.ncbi.nlm.nih.gov/pubmed/35943790 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 8 %P e35482 %T Adding an App-Based Intervention to the Cognitive Behavioral Analysis System of Psychotherapy in Routine Outpatient Psychotherapy Treatment: Proof-of-Concept Study %A Netter,Anna-Lena %A Beintner,Ina %A Brakemeier,Eva-Lotta %+ Department of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Gutenberg Strasse 18, Marburg, 32035, Germany, 49 64212823757, anna-lena.netter@uni-marburg.de %K Cognitive Behavioral Analysis System of Psychotherapy %K persistent depressive disorder %K blended therapy %K internet and mobile-based Interventions %K routine clinical care %K eHealth %K mobile phone %D 2022 %7 9.8.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is an empirically supported psychotherapeutic treatment developed specifically for persistent depressive disorder. However, given the high rates of nonresponse and relapse, there is a need for optimization. Studies suggest that outcomes can be improved by increasing the treatment dose via, for example, the continuous web-based application of therapy strategies between sessions. The strong emphasis in CBASP on the therapeutic relationship, combined with limited therapeutic availabilities, encourages the addition of web-based interventions to face-to-face therapy in terms of blended therapy. Objective: The aim of this study was to test an app-based intervention called CBASPath, which was designed to be used as a blended therapy tool. CBASPath offers 8 sequential modules with app-based exercises to facilitate additional engagement with the therapy content and a separate exercise to conduct situational analyses within the app at any time. Methods: CBASPath was tested in an open pilot study as part of routine outpatient CBASP treatment. Participating patients were asked to report their use patterns and blended use (integrated use of the app as part of therapy sessions) at 3 assessment points over the 6-month test period and rate the usability and quality of and their satisfaction with CBASPath. Results: The results of the pilot trial showed that 93% (12/13) of participants used CBASPath as a blended tool during their therapy and maintained this throughout the study period. Overall, they reported good usability and quality ratings along with high user satisfaction. All participants showed favorable engagement with CBASPath; however, the frequency of use differed widely among the participants and assessment points. Situational analysis was used by all participants, and the number of completed modules ranged from 1 to 7. All participants reported blended use, although the frequency of integration in the face-to-face sessions varied widely. Conclusions: Our findings suggest that the digital augmentation of complex and highly interactive CBASP therapy in the form of blended therapy with CBASPath is feasible in routine outpatient care. Therapeutic guidance might contribute to high adherence and increase patient self-management. A few adjustments, such as saving entries directly in the app, could facilitate higher user engagement. A randomized controlled trial is now needed to investigate the efficacy and added value of this blended approach. In the long term, CBASPath could help optimize persistent depressive disorder treatment and reduce relapse by intensifying therapy and providing long-term patient support through the app. %M 35943764 %R 10.2196/35482 %U https://formative.jmir.org/2022/8/e35482 %U https://doi.org/10.2196/35482 %U http://www.ncbi.nlm.nih.gov/pubmed/35943764 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 8 %P e28851 %T A Psychological Support Intervention to Help Injured Athletes “Get Back in the Game”: Design and Development Study %A Ardern,Clare L %A Hooper,Nicholas %A O'Halloran,Paul %A Webster,Kate E %A Kvist,Joanna %+ Department of Family Practice, University of British Columbia, Robert H.N. Ho Research Centre (level 6), 2635 Laurel Street, Vancouver, BC, V5Z 1M9, Canada, 1 6046752575, clare.ardern@liu.se %K sports %K medicine %K rehabilitation %K sports injury %K psychological support %K mental health %K postoperative medicine %K feasibility %K eHealth %K mobile phone %D 2022 %7 9.8.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: After a serious knee injury, up to half of athletes do not return to competitive sport, despite recovering sufficient physical function. Athletes often desire psychological support for the return to sport, but rehabilitation clinicians feel ill-equipped to deliver adequate support. Objective: We aimed to design and develop an internet-delivered psychological support program for athletes recovering from knee ligament surgery. Methods: Our work for developing and designing the Back in the Game intervention was guided by a blend of theory-, evidence-, and target population–based strategies for developing complex interventions. We systematically searched for qualitative evidence related to athletes’ experiences with, perspectives on, and needs for recovery and return to sport after anterior cruciate ligament (ACL) injury. Two reviewers coded and synthesized the results via thematic meta-synthesis. We systematically searched for randomized controlled trials reporting on psychological support interventions for improving ACL rehabilitation outcomes in athletes. One reviewer extracted the data, including effect estimates; a second reviewer checked the data for accuracy. The results were synthesized descriptively. We conducted feasibility testing in two phases—(1) technical assessment and (2) feasibility and usability testing. For phase 1, we recruited clinicians and people with lived experience of ACL injury. For phase 2, we recruited patients aged between 15 and 30 years who were within 8 weeks of ACL reconstruction surgery. Participants completed a 10-week version of the intervention and semistructured interviews for evaluating acceptability, demand, practicality, and integration. This project was approved by the Swedish Ethical Review Authority (approval number: 2018/45-31). Results: The following three analytic themes emerged from the meta-synthesis (studies: n=16; participants: n=164): (1) tools or strategies for supporting rehabilitation progress, (2) barriers and facilitators for the physical readiness to return to sport, and (3) barriers and facilitators for the psychological readiness to return to sport. Coping strategies, relaxation, and goal setting may have a positive effect on rehabilitation outcomes after ACL reconstruction (randomized controlled trials: n=7; participants: n=430). There were no trials of psychological support interventions for improving the return to sport. Eleven people completed phase 1 of feasibility testing (technical assessment) and identified 4 types of software errors, which we fixed. Six participants completed the feasibility and usability testing phase. Their feedback suggested that the intervention was easy to access and addressed the needs of athletes who want to return to sport after ACL reconstruction. We refined the intervention to include more multimedia content and support access to and the use of the intervention features. Conclusions: The Back in the Game intervention is a 24-week, internet-delivered, self-guided program that comprises 7 modules that complement usual rehabilitation, changes focus as rehabilitation progresses, is easy to access and use, and includes different psychological support strategies. %M 35943769 %R 10.2196/28851 %U https://formative.jmir.org/2022/8/e28851 %U https://doi.org/10.2196/28851 %U http://www.ncbi.nlm.nih.gov/pubmed/35943769 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e40181 %T Self-management Interventions for People With Parkinson Disease: Scoping Review %A Milne-Ives,Madison %A Carroll,Camille %A Meinert,Edward %+ Centre for Health Technology, University of Plymouth, 6 Kirkby Place, Room 2, Plymouth, PL4 6DN, United Kingdom, 44 01752600600, edward.meinert@plymouth.ac.uk %K Parkinson disease %K self-management %K self-care %K home nursing %K self-efficacy %K quality of life %K signs and symptoms %K health behaviour %D 2022 %7 5.8.2022 %9 Review %J J Med Internet Res %G English %X Background: Parkinson disease can impose substantial distress and costs on patients, their families and caregivers, and health care systems. To address these burdens for families and health care systems, there is a need to better support patient self-management. To achieve this, an overview of the current state of the literature on self-management is needed to identify what is being done, how well it is working, and what might be missing. Objective: The aim of this scoping review was to provide an overview of the current body of research on self-management interventions for people with Parkinson disease and identify any knowledge gaps. Methods: The PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) and Population, Intervention, Comparator, Outcome, and Study type frameworks were used to structure the methodology of the review. Due to time and resource constraints, 1 reviewer systematically searched 4 databases (PubMed, Ovid, Scopus, and Web of Science) for the evaluations of self-management interventions for Parkinson disease published in English. The references were screened using the EndNote X9 citation management software, titles and abstracts were manually reviewed, and studies were selected for inclusion based on the eligibility criteria. Data were extracted into a pre-established form and synthesized in a descriptive analysis. Results: There was variation among the studies on study design, sample size, intervention type, and outcomes measured. The randomized controlled trials had the strongest evidence of effectiveness: 5 out of 8 randomized controlled trials found a significant difference between groups favoring the intervention on their primary outcome, and the remaining 3 had significant effects on at least some of the secondary outcomes. The 2 interventions included in the review that targeted mental health outcomes both found significant changes over time, and the 3 algorithms evaluated performed well. The remaining studies examined patient perceptions, acceptability, and cost-effectiveness and found generally positive results. Conclusions: This scoping review identified a wide variety of interventions designed to support various aspects of self-management for people with Parkinson disease. The studies all generally reported positive results, and although the strength of the evidence varied, it suggests that self-management interventions are promising for improving the care and outcomes of people with Parkinson disease. However, the research tended to focus on the motor aspects of Parkinson disease, with few nonmotor or holistic interventions, and there was a lack of evaluation of cost-effectiveness. This research will be important to providing self-management interventions that meet the varied and diverse needs of people with Parkinson disease and determining which interventions are worth promoting for widespread adoption. %M 35930315 %R 10.2196/40181 %U https://www.jmir.org/2022/8/e40181 %U https://doi.org/10.2196/40181 %U http://www.ncbi.nlm.nih.gov/pubmed/35930315 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 8 %P e35599 %T Development and Use of a Cardiac Clinical Guideline Mobile App in Australia: Acceptability and Multi-Methods Study %A Matthews,Stacey %A Atkins,Brooke %A Walton,Natalie %A Mitchell,Julie-Anne %A Jennings,Garry %A Buttery,Amanda K %+ National Heart Foundation of Australia, Level 2, 850 Collins street, Melbourne, 3008, Australia, 61 03 9321 1593, stacey.matthews@heartfoundation.org.au %K mHealth %K mobile heath %K apps %K app %K guideline %K cardiovascular disease %K atrial fibrillation %K heart failure %K heart %K cardiac %K cardiovascular %K acute coronary syndrome %K smartphone %K implementation %K digital health %K develop %K evaluate %K evaluation %K Australia %D 2022 %7 5.8.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Implementation of clinical guidelines into routine practice remains highly variable. Strategies to increase guideline uptake include developing digital tools and mobile apps for use in clinical practice. The National Heart Foundation of Australia in collaboration with the Cardiac Society of Australia and New Zealand published 3 key cardiac clinical guidelines, including the Australian clinical guidelines for the (1) prevention and detection of atrial fibrillation, (2) detection and management of heart failure, and (3) management of acute coronary syndromes. To improve access and uptake for health care providers, we developed the Smart Heart Guideline App. Objective: This study aims to evaluate the acceptability, implementation, and usability of an Australian-specific cardiac guidelines mobile app. Methods: We used an iterative multiple methods development and implementation approach. First, we conducted a cross-sectional web-based survey with end users (n=504 health professionals) in 2017 to determine the acceptability of an Australian-specific cardiac clinical guidelines mobile app. Second, the Smart Heart Guidelines app was created using a design, user testing, and revision process. The app includes interactive algorithms and flowcharts to inform diagnosis and management at the point of care. The freely available app was launched in October 2019 on iOS and Android operating systems and promoted and implemented using multiple methods. Third, data from 2 annual national cross-sectional general practitioner (GP) surveys in 2019 and 2020 were evaluated to understand the awareness and use of the clinical guidelines and the app. Fourth, data from the app stores were analyzed between October 1, 2019, and June 30, 2021, to evaluate usage. Results: Most health professionals surveyed (447/504, 89%) reported accessing resources electronically, and most (318/504, 63%) reported that they would use an Australian-specific cardiac guidelines app. GPs surveyed in 2019 were aware of the heart failure (159/312, 51%) and atrial fibrillation (140/312, 45%) guidelines, and in 2020, a total of 34 of 189 (18%) reported that they were aware of the app. The app was downloaded 11,313 times (7483, 66% from the Apple App Store; 3830, 34% from Google Play) during the first 20-month period. Most downloads (6300/7483, 84%) were a result of searching for the app in the stores. Monthly download rates varied. App Store data showed that people used the app twice (on average 2.06 times) during the 20 months. Many (3256/3830, 85%) Android users deleted the app. Conclusions: Health professionals supported the development of the Smart Heart Guidelines app. Although initial downloads were promising, the frequency of using the app was low and deletion rates were high. Further evaluation of users’ experience of the most and least useful components of the app is needed. %M 35930350 %R 10.2196/35599 %U https://formative.jmir.org/2022/8/e35599 %U https://doi.org/10.2196/35599 %U http://www.ncbi.nlm.nih.gov/pubmed/35930350 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 8 %P e38247 %T Programmatic Adoption and Implementation of Video-Observed Therapy in Minnesota: Prospective Observational Cohort Study %A Bachina,Preetham %A Lippincott,Christopher Kirk %A Perry,Allison %A Munk,Elizabeth %A Maltas,Gina %A Bohr,Rebecca %A Rock,Robert Bryan %A Shah,Maunank %+ Division of Infectious Diseases, Johns Hopkins School of Medicine, CRB-II, 1M-10, 1550 Orleans St, Baltimore, MD, 21287, United States, 1 4432870401, mshah28@jhmi.edu %K video directly observed therapy %K vDOT %K mobile health %K mHealth %K tuberculosis %K medication adherence %K telemedicine %K treatment %K telehealth %K observed therapy %K COVID-19 %K primary outcome %K treatment adherence %K technology adoption %K virtual health %D 2022 %7 5.8.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: In-person directly observed therapy (DOT) is standard of care for tuberculosis (TB) treatment adherence monitoring in the US, with increasing use of video-DOT (vDOT). In Minneapolis, vDOT became available in 2019. Objective: In this paper, we aimed to evaluate the use and effectiveness of vDOT in a program setting, including comparison of verified adherence among those receiving vDOT and in-person DOT. We also sought to understand the impact of COVID-19 on TB treatment adherence and technology adoption. Methods: We abstracted routinely collected data on individuals receiving therapy for TB in Minneapolis, MN, between September 2019 and June 2021. Our primary outcomes were to assess vDOT use and treatment adherence, defined as the proportion of prescribed doses (7 days per week) verified by observation (in person versus video-DOT), and to compare individuals receiving therapy in the pre–COVID-19 (before March 2020), and post–COVID-19 (after March 2020) periods; within the post–COVID-19 period, we evaluated early COVID-19 (March-August 2020), and intra–COVID-19 (after August 2020) periods. Results: Among 49 patients with TB (mean age 41, SD 19; n=27, 55% female and n=47, 96% non–US born), 18 (36.7%) received treatment during the post–COVID-19 period. Overall, verified adherence (proportion of observed doses) was significantly higher when using vDOT (mean 81%, SD 17.4) compared to in-person DOT (mean 54.5%, SD 10.9; P=.001). The adoption of vDOT increased significantly from 35% (11/31) of patients with TB in the pre–COVID-19 period to 67% (12/18) in the post–COVID-19 period (P=.04). Consequently, overall verified (ie, observed) adherence among all patients with TB in the clinic improved across the study periods (56%, 67%, and 79%, P=.001 for the pre–, early, and intra–COVID-19 periods, respectively). Conclusions: vDOT use increased after the COVID-19 period, was more effective than in-person DOT at verifying ingestion of prescribed treatment, and led to overall increased verified adherence in the clinic despite the onset of the COVID-19 pandemic. %M 35834671 %R 10.2196/38247 %U https://formative.jmir.org/2022/8/e38247 %U https://doi.org/10.2196/38247 %U http://www.ncbi.nlm.nih.gov/pubmed/35834671 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 8 %P e35487 %T Web-Based Delivery of a Family-Based Dating Violence Prevention Program for Youth Who Have Been Exposed to Intimate Partner Violence: Protocol for an Acceptability and Feasibility Study %A Reyes,H Luz McNaughton %A Langoni,Eliana Gabriela Armora %A Sharpless,Laurel %A Blackburn,Natalie %A McCort,Agnieszka %A Macy,Rebecca J %A Moracco,Kathryn E %A Foshee,Vangie A %+ Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 135 Dauer Drive, 302 Rosenau Hall CB 7440, Chapel Hill, NC, 27599-7440, United States, 1 919 593 4081, mcnaught@email.unc.edu %K dating violence %K adolescents %K family-based prevention %K web-based delivery %K feasibility and acceptability %K mobile phone %D 2022 %7 5.8.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Children exposed to intimate partner violence (IPV) between caregivers are at an increased risk of becoming involved in dating violence during adolescence. However, to date, few adolescent dating violence (ADV) prevention programs have been developed for and evaluated with youth exposed to IPV. An exception is Moms and Teens for Safe Dates (MTSD), an evidence-based ADV prevention program for mothers or maternal caregivers (mothers) exposed to IPV and their teenagers. The MTSD program comprises a series of booklets that families complete together in a home that includes activities to promote positive family communication and healthy teenager relationships. We developed a web-adapted version of the MTSD program—entitled eMoms and Teens for Safe Dates (eMTSD)—to provide a delivery format that may increase program appeal for digitally oriented teenagers, lower dissemination costs, lower reading burden for low-literacy participants, and incorporate built-in cues and reminders to boost program adherence. Objective: This protocol is for a research study that has the following three main objectives: to assess the acceptability of eMTSD; to identify the feasibility of the research process, including program adherence and participant recruitment and assessment; and to explore the acceptability, feasibility, and preliminary efficacy of 2 features—text reminders and the creation of an action plan for engaging with the program—that may increase program uptake and completion. Methods: Approximately 100 mothers and their teenagers will be invited to complete eMTSD, which includes six 30-minute web-based modules over a 6-week period. Mothers will be recruited through community organizations and social media advertising and will be eligible to participate if they have at least 1 teenager aged 12 to 16 years living with them, have experienced IPV after the teenager was born, are not currently living with an abusive partner, and have access to an internet-enabled device. Using a factorial design, enrolled dyads will be randomized to the following four adherence support groups (n=25 dyads per group): text reminders and action planning, text reminders only, action planning only, and no adherence supports. All participants will complete brief web-based assessments at enrollment after each module is completed, after the full program is completed, and 90 days after enrollment. Program adherence will be tracked using website use metrics. Results: The data collected will be synthesized to assess the acceptability of the program and the feasibility of the study procedures. An exploratory analysis will examine the impact of adherence support on program completion levels. In November 2021, ethical approval was received and recruitment was initiated. Data collection is expected to continue until December 2022. Conclusions: The web-based delivery of a family-based healthy relationship program for teenagers exposed to IPV may offer a convenient, low-cost, and engaging approach to preventing ADV. The findings from this study are expected to guide future research. International Registered Report Identifier (IRRID): DERR1-10.2196/35487 %M 35930332 %R 10.2196/35487 %U https://www.researchprotocols.org/2022/8/e35487 %U https://doi.org/10.2196/35487 %U http://www.ncbi.nlm.nih.gov/pubmed/35930332 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 5 %N 3 %P e36975 %T A Web-Based Platform (CareVirtue) to Support Caregivers of People Living With Alzheimer Disease and Related Dementias: Mixed Methods Feasibility Study %A Boutilier,Justin J %A Loganathar,Priya %A Linden,Anna %A Scheer,Eleanore %A Noejovich,Sofia %A Elliott,Christian %A Zuraw,Matthew %A Werner,Nicole E %+ Department of Health and Wellness Design, Indiana University School of Public Health-Bloomington, 1025 E 7th St, Bloomington, IN, 47405, United States, 1 703 340 7177, newerner@iu.edu %K Alzheimer disease and related dementias %K mHealth %K caregivers %K dementia caregiving %K eHealth %K telehealth %D 2022 %7 4.8.2022 %9 Original Paper %J JMIR Aging %G English %X Background: People living with Alzheimer disease and related dementias (ADRD) require prolonged and complex care that is primarily managed by informal caregivers who face significant unmet needs regarding support for communicating and coordinating across their informal care network. To address this unmet need, we developed CareVirtue, which provides (1) the ability to invite care network members; (2) a care guide detailing the care plan; (3) a journal where care network members can document, communicate, and coordinate; (4) a shared calendar; and (5) vetted geolocated caregiver resources. Objective: This study aims to evaluate CareVirtue’s feasibility based on: (1) Who used CareVirtue? (2) How did caregivers use CareVirtue? (3) How did caregivers perceive the acceptability of CareVirtue? (4) What factors were associated with CareVirtue use? Methods: We conducted a feasibility study with 51 care networks over a period of 8 weeks and used a mixed methods approach that included both quantitative CareVirtue usage data and semistructured interviews. Results: Care networks ranged from 1 to 8 members. Primary caregivers were predominantly female (38/51, 75%), White (44/51, 86%), married (37/51, 73%), college educated (36/51, 71%), and were, on average, 60.3 (SD 9.8) years of age, with 18% (9/51) living in a rural area. CareVirtue usage varied along 2 axes (total usage and type of usage), with heterogeneity in how the most engaged care networks interacted with CareVirtue. Interviews identified a range of ways CareVirtue was useful, including practically, organizationally, and emotionally. On the Behavioral Intention Scale, 72% (26/36) of primary caregivers reported an average score of at least 3, indicating an above average intention to use. The average was 81.8 (SD 12.8) for the System Usability Scale score, indicating “good” usability, and 3.4 (SD 1.0) for perceived usefulness, suggesting above average usefulness. The average confidence score increased significantly over the study duration from 7.8 in week 2 to 8.9 in week 7 (P=.005; r=0.91, 95% CI 0.84-0.95). The following sociodemographic characteristics were associated with posting in the journal: retired (mean 59.5 posts for retired caregivers and mean 16.9 for nonretired caregivers), income (mean 13 posts for those reporting >US $100K and mean 55.4 for those reporting 10 minutes, or >10 pages) predicted greater improvement in stress appraisals (all P values <.05). Conclusions: The results provide initial evidence that asynchronous psychosocial interventions delivered via a web application to sexual and gender minority youth can support their ability to cope with minority stress. Further research is needed to examine the long-term effects of the imi application. Trial Registration: ClinicalTrials.gov NCT05061966; https://clinicaltrials.gov/ct2/show/NCT05061966 %M 35916700 %R 10.2196/39094 %U https://www.jmir.org/2022/8/e39094 %U https://doi.org/10.2196/39094 %U http://www.ncbi.nlm.nih.gov/pubmed/35916700 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 8 %N 3 %P e37502 %T Integrating Top-down and Bottom-up Requirements in eHealth Development: The Case of a Mobile Self-compassion Intervention for People With Newly Diagnosed Cancer %A Austin,Judith %A Drossaert,Constance H C %A van Dijk,Jelle %A Sanderman,Robbert %A Børøsund,Elin %A Mirkovic,Jelena %A Schotanus-Dijkstra,Marijke %A Peeters,Nienke J %A Van 't Klooster,Jan-Willem J R %A Schroevers,Maya J %A Bohlmeijer,Ernst T %+ Section of Psychology, Health & Technology, Faculty of Behavioural, Management and Social Sciences, University of Twente, PO Box 217, Enschede, 7500AE, Netherlands, 31 534897024, judith.austin@hotmail.com %K eHealth %K cancer %K self-compassion %K co-design %K requirements %K evidence-based %K mobile phone %D 2022 %7 1.8.2022 %9 Original Paper %J JMIR Cancer %G English %X Background: Psychosocial eHealth interventions for people with cancer are promising in reducing distress; however, their results in terms of effects and adherence rates are quite mixed. Developing interventions with a solid evidence base while still ensuring adaptation to user wishes and needs is recommended to overcome this. As most models of eHealth development are based primarily on examining user experiences (so-called bottom-up requirements), it is not clear how theory and evidence (so-called top-down requirements) may best be integrated into the development process. Objective: This study aims to investigate the integration of top-down and bottom-up requirements in the co-design of eHealth applications by building on the development of a mobile self-compassion intervention for people with newly diagnosed cancer. Methods: Four co-design tasks were formulated at the start of the project and adjusted and evaluated throughout: explore bottom-up experiences, reassess top-down content, incorporate bottom-up and top-down input into concrete features and design, and synergize bottom-up and top-down input into the intervention context. These tasks were executed iteratively during a series of co-design sessions over the course of 2 years, in which 15 people with cancer and 7 nurses (recruited from 2 hospitals) participated. On the basis of the sessions, a list of requirements, a final intervention design, and an evaluation of the co-design process and tasks were yielded. Results: The final list of requirements included intervention content (eg, major topics of compassionate mind training such as psychoeducation about 3 emotion systems and main issues that people with cancer encounter after diagnosis such as regulating information consumption), navigation, visual design, implementation strategies, and persuasive elements. The final intervention, Compas-Y, is a mobile self-compassion training comprising 6 training modules and several supportive functionalities such as a mood tracker and persuasive elements such as push notifications. The 4 co-design tasks helped overcome challenges in the development process such as dealing with conflicting top-down and bottom-up requirements and enabled the integration of all main requirements into the design. Conclusions: This study addressed the necessary integration of top-down and bottom-up requirements into eHealth development by examining a preliminary model of 4 co-design tasks. Broader considerations regarding the design of a mobile intervention based on traditional intervention formats and merging the scientific disciplines of psychology and design research are discussed. %M 35916691 %R 10.2196/37502 %U https://cancer.jmir.org/2022/3/e37502 %U https://doi.org/10.2196/37502 %U http://www.ncbi.nlm.nih.gov/pubmed/35916691 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 7 %P e34254 %T The Impact of Mobile Technology-Delivered Interventions on Youth Well-being: Systematic Review and 3-Level Meta-analysis %A Conley,Colleen S %A Raposa,Elizabeth B %A Bartolotta,Kate %A Broner,Sarah E %A Hareli,Maya %A Forbes,Nicola %A Christensen,Kirsten M %A Assink,Mark %+ Department of Psychology, Loyola University Chicago, 1032 W. Sheridan Road, Chicago, IL, 60660, United States, 1 7735083603, cconley@luc.edu %K meta-analysis %K mental health %K well-being %K intervention %K treatment %K youth %K technology %K smartphone %K mobile phone %K app %K mobile health %D 2022 %7 29.7.2022 %9 Review %J JMIR Ment Health %G English %X Background: Rates of mental health problems among youth are high and rising, whereas treatment seeking in this population remains low. Technology-delivered interventions (TDIs) appear to be promising avenues for broadening the reach of evidence-based interventions for youth well-being. However, to date, meta-analytic reviews on youth samples have primarily been limited to computer and internet interventions, whereas meta-analytic evidence on mobile TDIs (mTDIs), largely comprising mobile apps for smartphones and tablets, have primarily focused on adult samples. Objective: This study aimed to evaluate the effectiveness of mTDIs for a broad range of well-being outcomes in unselected, at-risk, and clinical samples of youth. Methods: The systematic review used 5 major search strategies to identify 80 studies evaluating 83 wellness- and mental health-focused mTDIs for 19,748 youth (mean age 2.93-26.25 years). We conducted a 3-level meta-analysis on the full sample and a subsample of the 38 highest-quality studies. Results: Analyses demonstrated significant benefits of mTDIs for youth both at posttest (g=0.27) and follow-up (range 1.21-43.14 weeks; g=0.26) for a variety of psychosocial outcomes, including general well-being and distress, symptoms of diverse psychological disorders, psychosocial strategies and skills, and health-related symptoms and behaviors. Effects were significantly moderated by the type of comparison group (strongest for no intervention, followed by inert placebo or information-only, and only marginal for clinical comparison) but only among the higher-quality studies. With respect to youth characteristics, neither gender nor pre-existing mental health risk level (not selected for risk, at-risk, or clinical) moderated effect sizes; however, effects increased with the age of youth in the higher-quality studies. In terms of intervention features, mTDIs in these research studies were effective regardless of whether they included various technological features (eg, tailoring, social elements, or gamification) or support features (eg, orientation, reminders, or coaching), although the use of mTDIs in a research context likely differs in important ways from their use when taken up through self-motivation, parent direction, peer suggestion, or clinician referral. Only mTDIs with a clear prescription for frequent use (ie, at least once per week) showed significant effects, although this effect was evident only in the higher-quality subsample. Moderation analyses did not detect statistically significant differences in effect sizes based on the prescribed duration of mTDI use (weeks or sessions), and reporting issues in primary studies limited the analysis of completed duration, thereby calling for improved methodology, assessment, and reporting to clarify true effects. Conclusions: Overall, this study’s findings demonstrate that youth can experience broad and durable benefits of mTDIs, delivered in a variety of ways, and suggest directions for future research and development of mTDIs for youth, particularly in more naturalistic and ecologically valid settings. %M 35904845 %R 10.2196/34254 %U https://mental.jmir.org/2022/7/e34254 %U https://doi.org/10.2196/34254 %U http://www.ncbi.nlm.nih.gov/pubmed/35904845 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 3 %P e38704 %T Digital Graphic Follow-up Tool (Rehabkompassen) for Identifying Rehabilitation Needs Among People After Stroke: Randomized Clinical Feasibility Study %A Hu,Xiaolei %A Jonzén,Karolina %A Lindahl,Olof A %A Karlsson,Marcus %A Norström,Fredrik %A Lundström,Erik %A Sunnerhagen,Katharina Stibrant %+ Department of Community Medicine and Rehabilitation, Umeå University, Umeå, 901 87, Sweden, 46 705956708, xiaolei.hu@umu.se %K stroke %K rehabilitation %K needs assessment %K outcome assessment %K structured follow-up: follow-up %K digital tool %K digital health %K eHealth %K feasibility %K randomized controlled trial %K RCT %K adherence %K acceptability %K clinical setting %K Rankin scale %K outpatient %D 2022 %7 29.7.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Stroke is a leading cause of disability among adults, with heavy social and economic burden worldwide. A cost-effective solution is urgently needed to facilitate the identification of individual rehabilitation needs and thereby provide tailored rehabilitations to reduce disability among people who have had a stroke. A novel digital graphic follow-up tool Rehabkompassen has recently been developed to facilitate capturing the multidimensional rehabilitation needs of people who have had a stroke. Objective: The aim of this study was to evaluate the feasibility and acceptability of conducting a definitive trial to evaluate Rehabkompassen as a digital follow-up tool among people who have had a stroke in outpatient clinical settings. Methods: This pilot study of Rehabkompassen was a parallel, open-label, 2-arm prospective, proof-of-concept randomized controlled trial (RCT) with an allocation ratio of 1:1 in a single outpatient clinic. Patients who have had a stroke within the 3 previous months, aged ≥18 years, and living in the community were included. The trial compared usual outpatient visits with Rehabkompassen (intervention group) and without Rehabkompassen (control group) at the 3-month follow-up as well as usual outpatient visit with Rehabkompassen at the 12-month follow-up. Information on the recruitment rate, delivery, and uptake of Rehabkompassen; assessment and outcome measures completion rates; the frequency of withdrawals; the loss of follow-up; and satisfaction scores were obtained. The key outcomes were evaluated in both groups. Results: In total, 28 patients (14 control, 14 Rehabkompassen) participated in this study, with 100 patients screened. The overall recruitment rate was 28% (28/100). Retention in the trial was 86% (24/28) at the 12-month follow-up. All participants used the tool as planned during their follow-ups, which provided a 100% (24/24) task completion rate of using Rehabkompassen and suggested excellent feasibility. Both patient- and physician-participants reported satisfaction with the instrument (19/24, 79% and 2/2, 100%, respectively). In all, 2 (N=2, 100%) physicians and 18 (N=24, 75%) patients were willing to use the tool in the future. Furthermore, modified Rankin Scale as the primary outcome and various stroke impacts as secondary outcomes were both successfully collected and compared in this study. Conclusions: This study demonstrated the high feasibility and adherence of the study protocol as well as the high acceptability of Rehabkompassen among patients who have had a stroke and physicians in an outpatient setting in comparison to the predefined criterion. The information collected in this feasibility study combined with the amendments of the study protocol may improve the future definitive RCT. The results of this trial support the feasibility and acceptability of conducting a large definitive RCT. Trial Registration: ClinicalTrials.gov NCT04915027; https://clinicaltrials.gov/ct2/show/NCT04915027 %M 35904867 %R 10.2196/38704 %U https://humanfactors.jmir.org/2022/3/e38704 %U https://doi.org/10.2196/38704 %U http://www.ncbi.nlm.nih.gov/pubmed/35904867 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 8 %N 3 %P e35893 %T Providing Care Beyond Therapy Sessions With a Natural Language Processing–Based Recommender System That Identifies Cancer Patients Who Experience Psychosocial Challenges and Provides Self-care Support: Pilot Study %A Leung,Yvonne W %A Park,Bomi %A Heo,Rachel %A Adikari,Achini %A Chackochan,Suja %A Wong,Jiahui %A Alie,Elyse %A Gancarz,Mathew %A Kacala,Martyna %A Hirst,Graeme %A de Silva,Daswin %A French,Leon %A Bender,Jacqueline %A Mishna,Faye %A Gratzer,David %A Alahakoon,Damminda %A Esplen,Mary Jane %+ de Souza Institute, University Health Network, 222 St Patrick St Office 503, Toronto, ON, M5T 1V4, Canada, 1 844 758 6891, yvonne.leung@desouzainstitute.com %K artificial intelligence %K natural language processing %K online support groups %K supportive care in cancer %K recommender system %D 2022 %7 29.7.2022 %9 Original Paper %J JMIR Cancer %G English %X Background: The negative psychosocial impacts of cancer diagnoses and treatments are well documented. Virtual care has become an essential mode of care delivery during the COVID-19 pandemic, and online support groups (OSGs) have been shown to improve accessibility to psychosocial and supportive care. de Souza Institute offers CancerChatCanada, a therapist-led OSG service where sessions are monitored by an artificial intelligence–based co-facilitator (AICF). The AICF is equipped with a recommender system that uses natural language processing to tailor online resources to patients according to their psychosocial needs. Objective: We aimed to outline the development protocol and evaluate the AICF on its precision and recall in recommending resources to cancer OSG members. Methods: Human input informed the design and evaluation of the AICF on its ability to (1) appropriately identify keywords indicating a psychosocial concern and (2) recommend the most appropriate online resource to the OSG member expressing each concern. Three rounds of human evaluation and algorithm improvement were performed iteratively. Results: We evaluated 7190 outputs and achieved a precision of 0.797, a recall of 0.981, and an F1 score of 0.880 by the third round of evaluation. Resources were recommended to 48 patients, and 25 (52%) accessed at least one resource. Of those who accessed the resources, 19 (75%) found them useful. Conclusions: The preliminary findings suggest that the AICF can help provide tailored support for cancer OSG members with high precision, recall, and satisfaction. The AICF has undergone rigorous human evaluation, and the results provide much-needed evidence, while outlining potential strengths and weaknesses for future applications in supportive care. %M 35904877 %R 10.2196/35893 %U https://cancer.jmir.org/2022/3/e35893 %U https://doi.org/10.2196/35893 %U http://www.ncbi.nlm.nih.gov/pubmed/35904877 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 7 %P e37666 %T Improving Health Knowledge Through Provision of Free Digital Health Education to Rural Communities in Iringa, Tanzania: Nonrandomized Intervention Study %A Holst,Christine %A Stelzle,Dominik %A Diep,Lien My %A Sukums,Felix %A Ngowi,Bernard %A Noll,Josef %A Winkler,Andrea Sylvia %+ Centre for Global Health, Department of Community Medicine and Global Health, Institute of Health and Society, University of Oslo, PO Box 1130, Blinderen, Oslo, 0318, Norway, 47 48234044, christine.holst@medisin.uio.no %K digital health %K digital health promotion %K eHealth %K mobile health %K mHealth %K Tanzania %K health education %K HIV/AIDS %K tuberculosis %K cysticercosis %K tapeworm %K mobile phone %D 2022 %7 28.7.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Community health education is one of the most effective measures to increase health literacy worldwide and can contribute to the achievement of specific targets of the Sustainable Development Goal 3. Digitalized health education materials can improve health knowledge as a dimension of health literacy and play an important role in disease prevention in rural sub-Saharan settings. Objective: The objective of this research is to assess the effect of a digital health education intervention on the uptake and retention of knowledge related to HIV/AIDS, tuberculosis (TB), and Taenia solium (neuro)cysticercosis and taeniosis in rural communities in Iringa, Tanzania. Methods: We conducted a nonrandomized intervention study of participants aged 15 to 45 years, randomly selected from 4 villages in Iringa, Tanzania. The intervention consisted of 2 parts. After the baseline assessment, we showed the participants 3 animated health videos on a tablet computer. After a period of 6 months, free access to community information spots (InfoSpots) with an integrated digital health education platform was provided to the intervention villages. Participants in the control group did not receive the intervention. The primary outcome was the difference in disease knowledge between the intervention and control groups, 12 months after baseline. Data were collected using an open-ended questionnaire, with correct or incorrect answers before and after intervention. Results: Between April and May 2019, a total of 600 participants were recruited into the intervention (n=298, 49.7%) or control (n=302, 50.3%) groups. At baseline, no statistically significant differences in knowledge of the target diseases were observed. At 12 months after intervention, knowledge about HIV/AIDS, TB, and T. solium (neuro)cysticercosis and taeniosis was 10.2% (95% CI 5.0%-15.4%), 12% (95% CI 7.7%-16.2%), and 31.5% (95% CI 26.8%-36.2%) higher in the intervention group than in the control group, respectively. In all 4 domains (transmission, symptoms, treatment, and prevention), an increase in knowledge was observed in all the 3 diseases, albeit to varying degrees. The results were adjusted for potential confounders, and the significance of the primary results was maintained in the sensitivity analysis to assess dropouts. The participants who reported using the InfoSpots in the 12-month assessment further increased their knowledge about the target diseases by 6.8% (HIV/AIDS), 7.5% (TB), and 13.9% higher mean proportion of correct answers compared with the participants who did not use the InfoSpots. Conclusions: Digital health education based on animated health videos and the use of free InfoSpots has significant potential to improve health knowledge, especially in rural areas of low- and middle-income countries. Trial Registration: ClinicalTrials.gov NCT03808597; https://clinicaltrials.gov/ct2/show/NCT03808597 International Registered Report Identifier (IRRID): RR2-10.2196/25128 %M 35900820 %R 10.2196/37666 %U https://www.jmir.org/2022/7/e37666 %U https://doi.org/10.2196/37666 %U http://www.ncbi.nlm.nih.gov/pubmed/35900820 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 7 %P e37430 %T Efficacy of Personalized Diabetes Self-care Using an Electronic Medical Record–Integrated Mobile App in Patients With Type 2 Diabetes: 6-Month Randomized Controlled Trial %A Lee,Eun Young %A Cha,Seon-Ah %A Yun,Jae-Seung %A Lim,Sun-Young %A Lee,Jin-Hee %A Ahn,Yu-Bae %A Yoon,Kun-Ho %A Hyun,Min Kyung %A Ko,Seung-Hyun %+ Division of Endocrinology and Metabolism, Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, 93, Jungbu-daero, Paldal-gu, Suwon, 16247, Republic of Korea, 82 0312498155, shkoh718@gmail.com %K type 2 diabetes mellitus %K digital health %K mobile health %K mHealth %K mobile app %K self-monitoring blood glucose %K mobile phone %D 2022 %7 28.7.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: A system that combines technology and web-based coaching can help treat chronic conditions such as diabetes. However, the effectiveness of apps in mobile health (mHealth) interventions is inconclusive and unclear due to heterogeneous interventions and varying follow-up durations. In addition, randomized controlled trial data are limited, and long-term follow-up is lacking, especially for apps integrated into electronic medical records. Objective: We aimed to assess the effect of an electronic medical record–integrated mobile app for personalized diabetes self-care, focusing on the self-monitoring of blood glucose and lifestyle modifications, on glycemic control in patients with type 2 diabetes mellitus. Methods: In a 26-week, 3-arm, randomized, controlled, open-label, parallel group trial, patients with type 2 diabetes mellitus and a hemoglobin A1c (HbA1c) level of ≥7.5% were recruited. The mHealth intervention consisted of self-monitoring of blood glucose with the automatic transfer of glucose, diet, and physical activity counseling data (iCareD system). Participants were randomly assigned to the following three groups: usual care (UC), mobile diabetes self-care (MC), and MC with personalized, bidirectional feedback from physicians (MPC). The primary outcome was the change in HbA1c levels at 26 weeks. In addition, diabetes-related self-efficacy, self-care activities, and satisfaction with the iCareD system were assessed after the intervention. Results: A total of 269 participants were enrolled, and 234 patients (86.9%) remained in the study at 26 weeks. At 12 weeks after the intervention, the mean decline in HbA1c levels was significantly different among the 3 groups (UC vs MC vs MPC: −0.49% vs −0.86% vs −1.04%; P=.02). The HbA1c level decreased in all groups; however, it did not differ among groups after 26 weeks. In a subgroup analysis, HbA1c levels showed a statistically significant decrease after the intervention in the MPC group compared with the change in the UC or MC group, especially in patients aged <65 years (P=.02), patients with a diabetes duration of ≥10 years (P=.02), patients with a BMI of ≥25.0 kg/m2 (P=.004), patients with a C-peptide level of ≥0.6 ng/mL (P=.008), and patients who did not undergo treatment with insulin (P=.004) at 12 weeks. A total of 87.2% (137/157) of the participants were satisfied with the iCareD system. Conclusions: The mHealth intervention for diabetes self-care showed short-term efficacy in glycemic control, and the effect decreased over time. The participants were comfortable with using the iCareD system and exhibited high adherence. Trial Registration: Clinical Research Information Service, Republic of Korea KCT0004128; https://tinyurl.com/bdd6pa9m %M 35900817 %R 10.2196/37430 %U https://www.jmir.org/2022/7/e37430 %U https://doi.org/10.2196/37430 %U http://www.ncbi.nlm.nih.gov/pubmed/35900817 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 7 %P e38616 %T Developing a Health Care Transition Intervention With Young People With Spinal Cord Injuries: Co-design Approach %A Bray,Emily Alice %A Everett,Bronwyn %A George,Ajesh %A Salamonson,Yenna %A Ramjan,Lucie M %+ School of Nursing and Midwifery, Western Sydney University, Locked Bag 1797, Penrith, 2751, Australia, 61 02 9685 9032, 16251104@student.westernsydney.edu.au %K co-design %K participatory action research %K health care transition %K pediatric health care %K adult health care %K spinal cord injury %D 2022 %7 28.7.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Successful transition from pediatric to adult health care settings supports long-term health management and better overall outcomes in all domains. However, young people with spinal cord injuries (SCIs) continue to report challenges and unmet needs during the transition process. Including end users in health care research and intervention design is paramount as interventions designed in this way better meet their specific needs and are often more innovative. Although studies have reported involving young people with chronic conditions in the development of health care transition (HCT) interventions, few details have been provided as to how this was achieved. Objective: This study outlined the co-design and development of an HCT intervention to support young people with SCIs. It contextualized the co-design process, methods, materials used, and steps implemented from defining the problem to conceiving and designing the solution. This was accomplished by understanding and listening to end users’ needs and recommendations for HCT. Methods: Using participatory methods, this qualitative study reports the co-design of an HCT intervention to support young people with SCIs and parents or caregivers. Two co-design workshops were conducted: one with young people with SCIs and one with parents and caregivers. Categories were defined through a hybrid deductive and inductive qualitative content analysis process that was informed by the Care Transitions Framework and guided the development of the HCT intervention. Following the creation of a prototype intervention, young people with SCIs, parents and caregivers, and key pediatric SCI stakeholders provided feedback on the intervention content and design in focus groups. Similar to the workshops, the focus groups were analyzed using a hybrid deductive and inductive qualitative content analysis process informed by the Care Transitions Framework. The Enhancing the Quality and Transparency of Health Research guidelines for qualitative research (Consolidated Criteria for Reporting Qualitative Research) were applied. Results: Overall, 4 young people and 4 parents or caregivers participated in the co-design workshops. Key recommendations for the HCT intervention were that participants wanted a “one-stop shop” for all their transition information needs and an editable portable medical summary to take with them to appointments. On the basis of the analysis of participants’ recommendations from the workshops, it was determined that a website would be an appropriate hosting platform for the interventions. The focus group feedback on the design and content of the prototype website was extremely positive, with minor recommendations for improvement. Conclusions: This is the first study to co-design and develop an HCT intervention in partnership with young people with SCIs and parents and caregivers. Although the study sample was small, it has shown that it is possible to meaningfully engage and empower young people with SCIs and parents and caregivers in the co-design of an HCT intervention. International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2021-053212 %M 35900814 %R 10.2196/38616 %U https://formative.jmir.org/2022/7/e38616 %U https://doi.org/10.2196/38616 %U http://www.ncbi.nlm.nih.gov/pubmed/35900814 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 7 %P e37891 %T Preferences in the Willingness to Download a COVID-19 Contact Tracing App in the Netherlands and Turkey: Experimental Study %A Folkvord,Frans %A Peschke,Lutz %A Ağca,Yasemin Gümüş %A van Houten,Karlijn %A Stazi,Giacomo %A Lupiáñez-Villanueva,Francisco %+ Tilburg School of Humanities and Digital Sciences, Tilburg University, Warrandelaan 2, Tilburg, 5037 AB, Netherlands, 31 682240480, fransfolkvord@gmail.com %K COVID-19 tracing app %K willingness to download %K discrete choice task %K pandemic %K mitigation strategies %K COVID-19 %K health application %K mobile health %K gaming %K tracing application %K digital health %K data protection %D 2022 %7 28.7.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Despite the worldwide growth in using COVID-19 contact tracing apps (CTAs) and the potential benefits for citizens, governments, health care professionals, businesses, and other organizations, only a few studies have examined the factors affecting the levels of willingness to download a CTA. Objective: This study aimed to investigate individuals’ preferences in the willingness to download a health app. Methods: We conducted an experimental study in 2 countries, the Netherlands (N=62) and Turkey (N=83), using 4 different vignettes (ie, data protection, manufacturer, reward, and gaming models) with different attributes. Participants were randomly assigned to 1 of the conditions within the vignettes. Results: The results showed that data protection and gaming elements are factors that influence the willingness to download a COVID-19 CTA. More specifically, we see that data protection is an important factor explaining the willingness to download the app in Turkey, whereas including gaming elements significantly affects the willingness to download the app in the Netherlands. Conclusions: COVID-19 CTAs are highly promising to reduce the spread of the virus and make it easier to open up society faster, especially because they can be used quickly and share information rapidly. COVID-19 CTA developers must ensure that their apps satisfactorily and sufficiently address ethical considerations, even in times of crisis. Furthermore, integrating gaming elements in the CTA could enhance the willingness to download the CTA. %M 35867840 %R 10.2196/37891 %U https://formative.jmir.org/2022/7/e37891 %U https://doi.org/10.2196/37891 %U http://www.ncbi.nlm.nih.gov/pubmed/35867840 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 7 %P e38100 %T Implementation of Web-Based Psychosocial Interventions for Adults With Acquired Brain Injury and Their Caregivers: Systematic Review %A Miao,Melissa %A Rietdijk,Rachael %A Brunner,Melissa %A Debono,Deborah %A Togher,Leanne %A Power,Emma %+ University of Technology Sydney, PO Box 123 Broadway, Ultimo, Sydney, 2007, Australia, 61 2 9514 1448, melissa.miao@uts.edu.au %K complexity %K implementation science %K internet interventions %K acquired brain injury %K delivery of health care %K caregivers %K digital health %K psychosocial interventions %K psychosocial %K brain injury %K mobile phone %D 2022 %7 26.7.2022 %9 Review %J J Med Internet Res %G English %X Background: More than 135 million people worldwide live with acquired brain injury (ABI) and its many psychosocial sequelae. This growing global burden necessitates scalable rehabilitation services. Despite demonstrated potential to increase the accessibility and scalability of psychosocial supports, digital health interventions are challenging to implement and sustain. The Nonadoption, Abandonment, Scale-Up, Spread, and Sustainability (NASSS) framework can offer developers and researchers a comprehensive overview of considerations to implement, scale, and sustain digital health interventions. Objective: This systematic review identified published, peer-reviewed primary evidence of implementation outcomes, strategies, and factors for web-based psychosocial interventions targeting either adults with ABI or their formal or informal caregivers; evaluated and summarized this evidence; synthesized qualitative and quantitative implementation data according to the NASSS framework; and provided recommendations for future implementation. Results were compared with 3 hypotheses which state that complexity (dynamic, unpredictable, and poorly characterized factors) in most or all NASSS domains increases likelihood of implementation failure; success is achievable, but difficult with many complicated domains (containing multiple interacting factors); and simplicity (straightforward, predictable, and few factors) in most or all domains increases the likelihood of success. Methods: From a comprehensive search of MEDLINE, EMBASE, PsycINFO, CINAHL, Scopus, speechBITE, and neuroBITE, we reviewed primary implementation evidence from January 2008 to June 2020. For web-based psychosocial interventions delivered via standard desktop computer, mobile phone, tablet, television, and virtual reality devices to adults with ABI or their formal or informal caregivers, we extracted intervention characteristics, stakeholder involvement, implementation scope and outcomes, study design and quality, and implementation data. Implementation data were both narratively synthesized and descriptively quantified across all 7 domains (condition, technology, value proposition, adopters, organization, wider system, and their interaction over time) and all subdomains of the NASSS framework. Study quality and risk of bias were assessed using the 2018 Mixed Methods Appraisal Tool. Results: We identified 60 peer-reviewed studies from 12 countries, including 5723 adults with ABI, 1920 carers, and 50 health care staff. The findings aligned with all 3 hypotheses. Conclusions: Although studies were of low methodological quality and insufficient number to statistically test relationships, the results appeared consistent with recommendations to reduce complexity as much as possible to facilitate implementation. Although studies excluded individuals with a range of comorbidities and sociocultural challenges, such simplification of NASSS domain 1 may have been necessary to advance intervention value propositions (domain 3). However, to create equitable digital health solutions that can be successfully implemented in real-world settings, it is recommended that developers involve people with ABI, their close others, and health care staff in addressing complexities in domains 2 to 7 from the earliest intervention design stages. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020186387; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020186387 International Registered Report Identifier (IRRID): RR2-10.1177/20552076211035988 %M 35881432 %R 10.2196/38100 %U https://www.jmir.org/2022/7/e38100 %U https://doi.org/10.2196/38100 %U http://www.ncbi.nlm.nih.gov/pubmed/35881432 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 7 %N 3 %P e33401 %T Effectiveness of a Diabetes-Focused Electronic Discharge Order Set and Postdischarge Nursing Support Among Poorly Controlled Hospitalized Patients: Randomized Controlled Trial %A White,Audrey %A Bradley,David %A Buschur,Elizabeth %A Harris,Cara %A LaFleur,Jacob %A Pennell,Michael %A Soliman,Adam %A Wyne,Kathleen %A Dungan,Kathleen %+ Division of Endocrinology, Diabetes & Metabolism, The Ohio State University, 517 McCampbell Hall, 1581 Dodd Drive, Columbus, OH, 43210, United States, 1 614 685 3333, kathleen.dungan@osumc.edu %K type 2 diabetes %K discharge %K order set %D 2022 %7 26.7.2022 %9 Original Paper %J JMIR Diabetes %G English %X Background: Although the use of electronic order sets has become standard practice for inpatient diabetes management, there is limited decision support at discharge. Objective: In this study, we assessed whether an electronic discharge order set (DOS) plus nurse follow-up calls improve discharge orders and postdischarge outcomes among hospitalized patients with type 2 diabetes mellitus. Methods: This was a randomized, open-label, single center study that compared an electronic DOS and nurse phone calls to enhanced standard care (ESC) in hospitalized insulin-requiring patients with type 2 diabetes mellitus. The primary outcome was change in glycated hemoglobin (HbA1c) level at 24 weeks after discharge. The secondary outcomes included the completeness and accuracy of discharge prescriptions related to diabetes. Results: This study was stopped early because of feasibility concerns related to the long-term follow-up. However, 158 participants were enrolled (DOS: n=82; ESC: n=76), of whom 155 had discharge data. The DOS group had a greater frequency of prescriptions for bolus insulin (78% vs 44%; P=.01), needles or syringes (95% vs 63%; P=.03), and glucometers (86% vs 36%; P<.001). The clarity of the orders was similar. HbA1c data were available for 54 participants in each arm at 12 weeks and for 44 and 45 participants in the DOS and ESC arms, respectively, at 24 weeks. The unadjusted difference in change in HbA1c level (DOS – ESC) was −0.6% (SD 0.4%; P=.18) at 12 weeks and −1.1% (SD 0.4%; P=.01) at 24 weeks. The adjusted difference in change in HbA1c level was −0.5% (SD 0.4%; P=.20) at 12 weeks and −0.7% (SD 0.4%; P=.09) at 24 weeks. The achievement of the individualized HbA1c target was greater in the DOS group at 12 weeks but not at 24 weeks. Conclusions: An intervention that included a DOS plus a postdischarge nurse phone call resulted in more complete discharge prescriptions. The assessment of postdischarge outcomes was limited, owing to the loss of the long-term follow-up, but it suggested a possible benefit in glucose control. Trial Registration: ClinicalTrials.gov NCT03455985; https://clinicaltrials.gov/ct2/show/NCT03455985 %M 35881437 %R 10.2196/33401 %U https://diabetes.jmir.org/2022/3/e33401 %U https://doi.org/10.2196/33401 %U http://www.ncbi.nlm.nih.gov/pubmed/35881437 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 7 %P e36280 %T Development and Initial Testing of a Personalized, Adaptive, and Socially Focused Web Tool to Support Physical Activity Among Women in Midlife: Multidisciplinary and User-Centered Design Approach %A Arigo,Danielle %A Lobo,Andrea F %A Ainsworth,M Cole %A Baga,Kiri %A Pasko,Kristen %+ Department of Psychology, Rowan University, 201 Mullica Hill Road, Robinson 116G, Glassboro, NJ, 08028, United States, 1 8562564500 ext 53775, arigo@rowan.edu %K user-centered design %K digital health %K eHealth %K women’s health %K midlife %K physical activity %K social support %K social comparison %K mobile phone %D 2022 %7 26.7.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Women in midlife are vulnerable to developing cardiovascular disease, particularly those who have conditions such as hypertension. Physical activity (PA) can reduce risk, but efforts to promote PA in this population have been only modestly effective. More attention to social influences on PA behavior may be useful, particularly social support and social comparison processes. Activating these processes with digital tools can provide easy access that is flexible to the needs of women in midlife. Objective: This paper describes the user-centered design processes of developing and conducting initial evaluation of a personalized and adaptive web application, tailored to the social needs of women in midlife. The goal was to gather feedback from the population of interest, before and during the design process. Methods: This study was conducted in 4 stages. The first and second authors (DA and AFL) developed technical specifications, informed by their experience with the population of interest. We collected feedback on potential content for the web application with women in midlife using both interviews (5/10, 50%; mean age 47.4, SD 6.66 years; mean BMI 35.3, SD 9.55 kg/m2) and surveys (5/10, 50%; mean age 51, SD 6.60 years; mean BMI 32.7, SD 8.39 kg/m2). We used their feedback to inform support messages and peer profiles (ie, sources of social comparison information). Nine members of the behavioral science team and 3 testers unfamiliar with the web application completed internal testing. We conducted naturalistic functionality testing with a different group of women in midlife (n=5; mean age 50, SD 6.26 years; mean BMI 30.1, SD 5.83 kg/m2), who used the web application as intended for 4 days and provided feedback at the end of this period. Results: Iterative storyboard development resulted in programming specifications for a prototype of the web application. We used content feedback to select and refine the support messages and peer profiles to be added. The following 2 rounds of internal testing identified bugs and other problems regarding the web application’s functioning and full data collection procedure. Problems were addressed or logged for future consideration. Naturalistic functionality testing revealed minimal further problems; findings showed preliminary acceptability of the web application and suggested that women may select different social content across days. Conclusions: A multidisciplinary and user-centered design approach led to a personalized and adaptive web application, tailored to the social needs of women in midlife. Findings from testing with this population demonstrated the feasibility and acceptability of the new application and supported further development toward its use in daily life. We describe several potential uses of the web application and next steps for its development. We also discuss the lessons learned and offer recommendations for future collaborations between behavioral and computer scientists to develop similar tools. %M 35881431 %R 10.2196/36280 %U https://formative.jmir.org/2022/7/e36280 %U https://doi.org/10.2196/36280 %U http://www.ncbi.nlm.nih.gov/pubmed/35881431 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 7 %P e38942 %T Impacts of Digital Care Programs for Musculoskeletal Conditions on Depression and Work Productivity: Longitudinal Cohort Study %A Costa,Fabíola %A Janela,Dora %A Molinos,Maria %A Moulder,Robert %A Bento,Vírgilio %A Lains,Jorge %A Scheer,Justin %A Yanamadala,Vijay %A Cohen,Steven %A Dias Correia,Fernando %+ SWORD Health Inc, 65 E Wadsworth Park Drive, Suite 230, Draper, UT, 84020, United States, 1 385 308 8034, fcorreia@swordhealth.com %K musculoskeletal %K pain %K depression %K anxiety %K mental health %K comorbidity %K productivity %K digital health %K remote care %K rehabilitation %K telehealth %K telemedicine %K eHealth %K digital health %K digital care %K multimodal %K digital intervention %K recovery %K engagement %K activities of daily living %K work %K job %K occupational health %K longitudinal cohort %D 2022 %7 25.7.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Comorbidity between musculoskeletal (MSK) pain and depression is highly common, and is associated with a greater symptom burden and greater loss of work productivity than either condition alone. Multimodal care programs tackling both physical and mental health components may maximize productivity recovery and return to work. Digital delivery of such programs can facilitate access, ensure continuity of care, and enhance patient engagement. Objective: The aim of this study was to assess the impact of a completely remote multimodal digital care program (DCP) for MSK pain on mental health and work-related outcomes stratified by baseline depression levels. Methods: Ad hoc analysis of an interventional, single-arm, cohort study of individuals with MSK pain undergoing a DCP was performed. Three subgroups with different baseline depression severity levels were established based on responses to the Patient Health Questionnaire (PHQ-9): cluster 1 (score<5: minimal depression), cluster 2 (scores 5-10: mild depression), and cluster 3 (score≥10: moderate depression). The mean changes in depression, anxiety, fear-avoidance beliefs, work productivity, and activity impairment and adherence between baseline and end of program (8-12 weeks) were assessed across subgroups by latent growth curve analysis. Results: From a total of 7785 eligible participants, 6137 (78.83%) were included in cluster 1, 1158 (14.87%) in cluster 2, and 490 (6.29%) in cluster 3. Significant improvements in depression and anxiety scores were observed in clusters 2 and 3 but not in cluster 1, with average end-of-the program scores in clusters 2 and 3 below the initially defined cluster thresholds (score of 5 and 10, respectively). All clusters reported significant improvements in productivity impairment scores (mean changes from –16.82, 95% CI –20.32 to –13.42 in cluster 1 to –20.10, 95% CI –32.64 to –7.57 in cluster 3). Higher adherence was associated with higher improvements in depression in clusters 2 and 3, and with greater recovery in activities of daily living in cluster 3. Overall patient satisfaction was 8.59/10.0 (SD 1.74). Conclusions: A multimodal DCP was able to promote improvements in productivity impairment scores comparable to those previously reported in the literature, even in participants with comorbid depression and anxiety. These results reinforce the need to follow a biopsychosocial framework to optimize outcomes in patients with MSK pain. Trial Registration: ClinicalTrials.gov NCT04092946; https://clinicaltrials.gov/ct2/show/NCT04092946 %M 35714099 %R 10.2196/38942 %U https://www.jmir.org/2022/7/e38942 %U https://doi.org/10.2196/38942 %U http://www.ncbi.nlm.nih.gov/pubmed/35714099 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 7 %P e36862 %T Providing Brief Personalized Therapies for Insomnia Among Workers Using a Sleep Prompt App: Randomized Controlled Trial %A Shimamoto,Tomonari %A Furihata,Ryuji %A Nakagami,Yukako %A Tateyama,Yukiko %A Kobayashi,Daisuke %A Kiyohara,Kosuke %A Iwami,Taku %+ Agency for Health, Safety and Environment, Kyoto University, Yoshida honmachi, Sakyo-ku, Kyoto, 606-8501, Japan, 81 75 753 2428 ext 2428, furihata.ryuji.2x@kyoto-u.ac.jp %K sleep prompt app %K smartphone %K brief personalized therapies for insomnia %K worker %K randomized controlled trial %K Japan %D 2022 %7 25.7.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Insomnia is the most common sleep disorder and the foremost health concern among workers. We developed a new sleep prompt app (SPA) for smartphones to positively alter the users' consciousness and behavior by sending timely short messages for mild sleep problems at an early stage. Objective: The aim of this study is to investigate the effectiveness of the SPA in providing brief personalized therapy for insomnia among workers. Methods: We conducted a 2-arm parallel randomized controlled trial. The intervention group used the SPA, and the control group received no intervention. Participants were recruited between November 2020 and January 2021. The researcher sent emails for recruitment to more than 3000 workers of 2 companies and 1 university in Japan. The SPA provided personalized prompt messages, sleep diaries, sleep hygiene education, stimulus control therapy, and sleep restriction therapy. The prompt messages were sent automatically to the participants to encourage them to improve their sleep habits and sleep status and were optimized to the individual's daily rhythm. The intervention program duration was 4 weeks. The primary outcome was a change in the Insomnia Severity Index (ISI) for the study period. The ISI was obtained weekly using a web questionnaire. Results: A total of 116 Japanese workers (intervention group n=60, control group n=56) with sleep disorders were recruited. Two participants in the intervention group were excluded from the analyses because of challenges in installing the SPA. The mean ISI scores at baseline were 9.2 for both groups; however, after 4 weeks, the mean ISI scores declined to 6.8 and 8.0 for the intervention and control groups, respectively. Primary analysis using a linear mixed model showed a significant improvement in the temporal trends of the ISI in the SPA group and in the total population (P=.03). Subgroup analyses of ISI-8-insomniacs revealed a significant improvement in the temporal trends of ISI in the SPA group (P=.01), and the CFS score for physical condition significantly improved following the intervention (P=.02). Conclusions: This study demonstrates the effectiveness of the SPA in providing brief personalized therapy for insomnia among Japanese workers with mild insomnia. The physical fatigue score significantly improved in ISI-8-insomniacs. Thus, SPA could play an important role in reducing the adverse effects of sleep disorders in workers. To promote the wide use of the SPA in the future, further studies are required to examine its effectiveness in other age groups and individuals with health problems. Trial Registration: University Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000042263; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046295 %M 35877164 %R 10.2196/36862 %U https://www.jmir.org/2022/7/e36862 %U https://doi.org/10.2196/36862 %U http://www.ncbi.nlm.nih.gov/pubmed/35877164 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 6 %N 2 %P e37490 %T Use of Digital Technology Tools to Characterize Adherence to Prescription-Grade Omega-3 Polyunsaturated Fatty Acid Therapy in Postmyocardial or Hypertriglyceridemic Patients in the DIAPAsOn Study: Prospective Observational Study %A Arutyunov,Gregory P %A Arutyunov,Alexander G %A Ageev,Fail T %A Fofanova,Tatiana V %+ Department of Internal Medicine, Pirogov Russian National Research Medical University, Ostrovityanova Street, Moscow, 117997, Russian Federation, 7 9103281989, arut@ossn.ru %K primary care %K research %K myocardial infarction %K cardiology %K heart %K cardiac %K cardiac health %K digital health %K electronic patient engagement %K eHealth %K patient engagement %K clinical report %K treatment %K treatment adherence %D 2022 %7 25.7.2022 %9 Original Paper %J JMIR Cardio %G English %X Background: Maintaining sustained adherence to medication for optimal management of chronic noninfectious diseases, such as atherosclerotic vascular disease, is a well-documented therapeutic challenge. Objective: The DIAPAsOn study was a 6-month, multicenter prospective observational study in the Russian Federation that examined adherence to a preparation of highly purified omega-3 polyunsaturated fatty acids (Omacor) in 2167 adult patients with a history of recent myocardial infarction or endogenous hypertriglyceridemia. Methods: A feature of DIAPAsOn was the use of a bespoke electronic patient engagement and data collection system to monitor adherence. Adherence was also monitored by enquiry at clinic visits. A full description of the study’s aims and methods has appeared in JMIR Research Protocols. Results: The net average reduction from baseline in both total and low-density lipoprotein cholesterol was approximately 1 mmol/L and the net average increase in high-density lipoprotein cholesterol was 0.2 (SD 0.53) mmol/L (P<.001 for all outcomes vs baseline). The mean triglyceride level was 3.0 (SD 1.3) mmol/L at visit 1, 2.0 (SD 0.9) mmol/L at visit 2, and 1.7 (SD 0.7) mmol/L at visit 3 (P<.001 for later visits vs visit 1). The percentage of patients with a triglyceride level <1.7 mmol/L rose from 13.1% (282/2151) at baseline to 54% (1028/1905) at the end of the study. Digital reporting of adherence was registered by 8.3% (180/2167) of patients; average scores indicted poor adherence. However, a clinic-based enquiry suggested high levels of adherence. Data on health-related quality of life accrued from digitally engaged patients identified improvements among patients reporting high adherence to study treatment, but patient numbers were small. Conclusions: The lipid and lipoprotein findings indicate that Omacor had nominally favorable effects on the blood lipid profile. Less than 10% of patients enrolled in DIAPAsOn used the bespoke digital platform piloted in the study, and the level of self-reported adherence to medication by these patients was also low. Reasons for this low uptake and adherence are unclear. Better adherence was recorded in clinical reports. Trial Registration: ClinicalTrials.gov NCT03415152; https://clinicaltrials.gov/ct2/show/NCT03415152 %M 35877173 %R 10.2196/37490 %U https://cardio.jmir.org/2022/2/e37490 %U https://doi.org/10.2196/37490 %U http://www.ncbi.nlm.nih.gov/pubmed/35877173 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 7 %P e39004 %T Single-Session Interventions Embedded Within Tumblr: Acceptability, Feasibility, and Utility Study %A Dobias,Mallory L %A Morris,Robert R %A Schleider,Jessica L %+ Department of Psychology, Stony Brook University, Psychology Building B-363, Stony Brook, NY, 11794-2500, United States, 1 512 818 9040, mallory.dobias@stonybrook.edu %K web-based intervention %K internet intervention %K digital intervention %K single-session intervention %K mental health %D 2022 %7 25.7.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Existing mental health treatments are insufficient for addressing mental health needs at scale, particularly for teenagers, who now seek mental health information and support on the web. Single-session interventions (SSIs) may be particularly well suited for dissemination as embedded web-based support options that are easily accessible on popular social platforms. Objective: We aimed to evaluate the acceptability and effectiveness of three SSIs, each with a duration of 5 to 8 minutes (Project Action Brings Change, Project Stop Adolescent Violence Everywhere, and REFRAME)—embedded as Koko minicourses on Tumblr—to improve three key mental health outcomes: hopelessness, self-hate, and the desire to stop self-harm behavior. Methods: We used quantitative data (ie, star ratings and SSI completion rates) to evaluate acceptability and short-term utility of all 3 SSIs. Paired 2-tailed t tests were used to assess changes in hopelessness, self-hate, and the desire to stop future self-harm from before to after the SSI. Where demographic information was available, the analyses were restricted to teenagers (13-19 years). Examples of positive and negative qualitative user feedback (ie, written text responses) were provided for each program. Results: The SSIs were completed 6179 times between March 2021 and February 2022. All 3 SSIs generated high star ratings (>4 out of 5 stars), with high completion rates (approximately 25%-57%) relative to real-world completion rates among other digital self-help interventions. Paired 2-tailed t tests detected significant pre-post reductions in hopelessness for those who completed Project Action Brings Change (P<.001, Cohen dz=−0.81, 95% CI −0.85 to −0.77) and REFRAME (P<.001, Cohen dz=−0.88, 95% CI −0.96 to −0.80). Self-hate significantly decreased (P<.001, Cohen dz=−0.67, 95% CI −0.74 to −0.60), and the desire to stop self-harm significantly increased (P<.001, Cohen dz=0.40, 95% CI 0.33 to 0.47]) from before to after the completion of Project Stop Adolescent Violence Everywhere. The results remained consistent across sensitivity analyses and after correcting for multiple tests. Examples of positive and negative qualitative user feedback point toward future directions for SSI research. Conclusions: Very brief SSIs, when embedded within popular social platforms, are one promising and acceptable method for providing free, scalable, and potentially helpful mental health support on the web. Considering the unique barriers to mental health treatment access that many teenagers face, this approach may be especially useful for teenagers without access to other mental health supports. %M 35877163 %R 10.2196/39004 %U https://formative.jmir.org/2022/7/e39004 %U https://doi.org/10.2196/39004 %U http://www.ncbi.nlm.nih.gov/pubmed/35877163 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 7 %P e34121 %T Translating Promoting Factors and Behavior Change Principles Into a Blended and Technology-Supported Intervention to Stimulate Physical Activity in Children With Asthma (Foxfit): Design Study %A Brons,Annette %A Braam,Katja %A Broekema,Aline %A Timmerman,Annieck %A Millenaar,Karel %A Engelbert,Raoul %A Kröse,Ben %A Visser,Bart %+ Digital Life Center, Amsterdam University of Applied Sciences, Wibautstraat 2-4, Amsterdam, 1091 GM, Netherlands, 31 621156976, a.e.brons@hva.nl %K intervention mapping %K technology-supported intervention %K mobile health %K mHealth %K tailoring %K exercise %K cocreation %K social participation %K gamification %K mobile app %K web-based dashboard %K chronic disease %K mobile phone %D 2022 %7 25.7.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Children with asthma can decrease the impact of their disease by improving their physical activity (PA). However, health care providers lack interventions for children with asthma that effectively increase their PA levels and achieve behavior change. A technology-supported approach can positively influence PA and physical functioning in children. Objective: The aims of this study were to develop a technology-supported intervention that facilitates health care providers in promoting PA for children (aged 8 to 12 years) with asthma and to systematically describe this developmental process. Methods: Intervention mapping (IM) was applied to develop a blended and technology-supported intervention in cocreation with children with asthma, their parents, and health care providers. In accordance with the IM framework, the following steps were performed: conduct a needs assessment; define the intervention outcome, performance objectives, and change objectives; select theory-based intervention methods and strategies; create components of the intervention and conduct pilot tests; create an implementation plan; and create an evaluation plan. Results: We developed the blended intervention Foxfit that consists of an app with a PA monitor for children (aged 8 to 12 years) with asthma and a web-based dashboard for their health care provider. The intervention focuses on PA in everyday life to improve social participation. Foxfit contains components based on behavior change principles and gamification, including goal setting, rewards, action planning, monitoring, shaping knowledge, a gamified story, personal coaching and feedback, and a tailored approach. An evaluation plan was created to assess the intervention’s usability and feasibility for both children and health care providers. Conclusions: The IM framework was very useful for systematically developing a technology-supported intervention and for describing the translational process from scientific evidence, the needs and wishes of future users, and behavior change principles into this intervention. This has led to the technology-supported intervention Foxfit that facilitates health care providers in promoting PA in children with asthma. The structured description of the development process and functional components shows the way behavior change techniques are incorporated in the intervention. Trial Registration: International Clinical Trial Registry Platform NTR6658; https://tinyurl.com/3rxejksf %M 35877162 %R 10.2196/34121 %U https://formative.jmir.org/2022/7/e34121 %U https://doi.org/10.2196/34121 %U http://www.ncbi.nlm.nih.gov/pubmed/35877162 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 7 %P e36727 %T eHealth and Web-Based Interventions for Informal Carers of People With Dementia in the Community: Umbrella Review %A Naunton Morgan,Bethan %A Windle,Gill %A Sharp,Rebecca %A Lamers,Carolien %+ School of Human and Behavioural Sciences, Bangor University, Brigantia Building, Penrallt Road, Bangor, United Kingdom, 44 01248 38 8107, psu2fc@bangor.ac.uk %K dementia %K Alzheimer disease %K informal %K family %K carers %K caregivers %K internet %K online %K technology %K interventions %D 2022 %7 22.7.2022 %9 Review %J J Med Internet Res %G English %X Background: The prevalence of dementia is increasing, and there are many associated problems that family members face as informal carers, including emotional, physical, and financial difficulties. There are benefits for a person with dementia to live at home for as long as possible, and therefore, supporting their informal carers is crucial. The growing interest in supporting carers through internet-based interventions is evidenced by the volume of systematic reviews on this topic. It is now appropriate to systematically examine this body of work and provide an overview of the literature. Objective: This umbrella review aimed to identify the most effective internet-based intervention content and delivery method to support those caring for someone with dementia living in the community. Methods: PsycINFO, Web of Science, CINAHL, MEDLINE, Cochrane Library, and PubMed were searched for systematic reviews examining the effectiveness of web-based interventions for informal carers of people with dementia. A total of 3 reviewers extracted data and evaluated the quality of the papers. To ascertain the extent to which the systematic reviews reported on the same evidence, the proportion of overlap between their included studies was calculated. Qualitative research findings were extracted and reported. Results: A total of 21 papers were included in the study. The quality of the review papers was mainly rated as low to moderate, and 10% (2/21) of papers were of high quality. The findings suggest that multicomponent interventions were the most effective in supporting carers. These included combinations of cognitive behavioral therapy and relaxation strategies, educational resources, and online support groups. Interventions that were delivered on the web but included sessions with a personal element, such as telephone contact, showed the best results. When comparing the studies reviewed in all the review papers, a moderate overlap was noted. However, when comparing individual reviews with each other, they showed a high overlap of the included studies. Conclusions: Mixed delivery methods and intervention content showed the most effective results in supporting those caring for people with dementia. However, many papers do not separate the results for differing intervention contents or delivery; this needs to be considered when drawing conclusions. There was an overlap among the studies included in the reviews. This suggests a lack of current research on the effectiveness of web-based interventions for people caring for a person with dementia. There was also a lack of consistency in the outcome measures across all papers. Future studies can involve updating research on the effectiveness of these interventions while distinguishing between different intervention types, thus creating guidelines for the use of standardized measures to enable comparisons of intervention effects and improve the scientific quality of the overall research. Trial Registration: PROSPERO CRD42021241559; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=241559 %M 35867388 %R 10.2196/36727 %U https://www.jmir.org/2022/7/e36727 %U https://doi.org/10.2196/36727 %U http://www.ncbi.nlm.nih.gov/pubmed/35867388 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 7 %P e36358 %T Evaluating the Efficacy of a Guided and Unguided Internet-Based Self-help Intervention for Chronic Loneliness: Protocol for a 3-Arm Randomized Controlled Trial %A Seewer,Noëmi %A Skoko,Andrej %A Käll,Anton %A Andersson,Gerhard %A Luhmann,Maike %A Berger,Thomas %A Krieger,Tobias %+ Department of Clinical Psychology and Psychotherapy, University of Bern, Fabrikstrasse 8, Bern, 3012, Switzerland, 41 31 684 40 35, noemi.seewer@unibe.ch %K loneliness %K subjective social isolation %K internet-based intervention %K self-help %K guidance %K online %K mobile phone %D 2022 %7 22.7.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Loneliness, or perceived social isolation, is prevalent in both the general population and clinical practice. Although loneliness has repeatedly been associated with mental and physical health, research on interventions that reduce loneliness effectively is still rather scarce. Objective: This study aims to evaluate the efficacy of a guided and an unguided version of the same internet-based cognitive behavioral self-help program for loneliness (SOLUS-D) for adults. Methods: A total of 250 participants will be randomly assigned to 1 of 2 intervention groups (SOLUS-D with guidance or SOLUS-D without guidance) or a wait-list control group (2:2:1 allocation ratio). Adult participants experiencing high levels of loneliness will be recruited from the general population. Individuals currently experiencing at least moderately severe depressive symptoms, an ongoing severe substance use disorder, previous or current bipolar or psychotic disorder, or acute suicidality will be excluded from the trial. Assessments will take place at baseline, 5 weeks (midassessment), and 10 weeks (postassessment). The primary outcome is loneliness assessed using the 9-item University of California, Los Angeles Loneliness Scale at the posttreatment time point. Secondary outcomes include depressive symptoms, symptoms of social anxiety, satisfaction with life, social network size, and variables assessing cognitive bias and social behavior. The maintenance of potentially achieved gains will be assessed and compared at 6 and 12 months after randomization in the 2 active conditions. Potential moderators and mediators will be tested exploratorily. Data will be analyzed on an intention-to-treat basis. Results: Recruitment and data collection started in May 2021 and are expected to be completed by 2022, with the 12-month follow-up to be completed by 2023. As of the time of submission of the manuscript, 134 participants were randomized. Conclusions: This 3-arm randomized controlled trial will add to the existing research on the efficacy of loneliness interventions. Furthermore, it will shed light on the role of human guidance in internet-based treatments for individuals with increased levels of loneliness and the possible mechanisms of change. If SOLUS-D proves effective, it could provide a low-threshold, cost-efficient method of helping and supporting individuals with increased levels of loneliness. Trial Registration: ClinicalTrials.gov NCT04655196; https://clinicaltrials.gov/ct2/show/NCT04655196 International Registered Report Identifier (IRRID): DERR1-10.2196/36358 %M 35867403 %R 10.2196/36358 %U https://www.researchprotocols.org/2022/7/e36358 %U https://doi.org/10.2196/36358 %U http://www.ncbi.nlm.nih.gov/pubmed/35867403 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 3 %P e37350 %T Integrating Natural Language Processing and Interpretive Thematic Analyses to Gain Human-Centered Design Insights on HIV Mobile Health: Proof-of-Concept Analysis %A Skeen,Simone J %A Jones,Stephen Scott %A Cruse,Carolyn Marie %A Horvath,Keith J %+ Department of Social, Behavioral, and Population Sciences, School of Public Health and Tropical Medicine, Tulane University, 2200-11, 1440 Canal Street, New Orleans, LA, 70112, United States, 1 504 988 1847, sskeen@tulane.edu %K mHealth %K mobile health %K HIV %K natural language %K thematic analysis %K human-centered design %K human-centered %K user-centered %K user-generated content %K proof-of-concept %K user feedback %K web-based %K web app %K men's health %K peer support %K informal support %K support group %K digital health %K eHealth %K sentiment %K design insight %K user insight %K Python %K model %K machine learning %D 2022 %7 21.7.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: HIV mobile health (mHealth) interventions often incorporate interactive peer-to-peer features. The user-generated content (UGC) created by these features can offer valuable design insights by revealing what topics and life events are most salient for participants, which can serve as targets for subsequent interventions. However, unstructured, textual UGC can be difficult to analyze. Interpretive thematic analyses can preserve rich narratives and latent themes but are labor-intensive and therefore scale poorly. Natural language processing (NLP) methods scale more readily but often produce only coarse descriptive results. Recent calls to advance the field have emphasized the untapped potential of combined NLP and qualitative analyses toward advancing user attunement in next-generation mHealth. Objective: In this proof-of-concept analysis, we gain human-centered design insights by applying hybrid consecutive NLP-qualitative methods to UGC from an HIV mHealth forum. Methods: UGC was extracted from Thrive With Me, a web app intervention for men living with HIV that includes an unstructured peer-to-peer support forum. In Python, topics were modeled by latent Dirichlet allocation. Rule-based sentiment analysis scored interactions by emotional valence. Using a novel ranking standard, the experientially richest and most emotionally polarized segments of UGC were condensed and then analyzed thematically in Dedoose. Design insights were then distilled from these themes. Results: The refined topic model detected K=3 topics: A: disease coping; B: social adversities; C: salutations and check-ins. Strong intratopic themes included HIV medication adherence, survivorship, and relationship challenges. Negative UGC often involved strong negative reactions to external media events. Positive UGC often focused on gratitude for survival, well-being, and fellow users’ support. Conclusions: With routinization, hybrid NLP-qualitative methods may be viable to rapidly characterize UGC in mHealth environments. Design principles point toward opportunities to align mHealth intervention features with the organically occurring uses captured in these analyses, for example, by foregrounding inspiring personal narratives and expressions of gratitude, or de-emphasizing anger-inducing media. %M 35862171 %R 10.2196/37350 %U https://humanfactors.jmir.org/2022/3/e37350 %U https://doi.org/10.2196/37350 %U http://www.ncbi.nlm.nih.gov/pubmed/35862171 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 7 %P e36135 %T Dosage Frequency Effects on Treatment Outcomes Following Self-managed Digital Therapy: Retrospective Cohort Study %A Cordella,Claire %A Munsell,Michael %A Godlove,Jason %A Anantha,Veera %A Advani,Mahendra %A Kiran,Swathi %+ Department of Speech, Language and Hearing Sciences, Boston University, 635 Commonwealth Ave, Boston, MA, 02215, United States, 1 617 353 2706, cordella@bu.edu %K aphasia %K stroke %K technology %K rehabilitation %K dosage %D 2022 %7 20.7.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Although the efficacy of high-dose speech-language therapy (SLT) for individuals with poststroke aphasia has been established in the literature, there is a gap in translating these research findings to clinical practice. Therefore, patients continue to receive suboptimal amounts of SLT, with negative consequences for their functional communication recovery. Recent research has identified self-managed digital health technology as one way to close the dosage gap by enabling high-intensity therapy unrestricted by clinician availability or other practical constraints. However, there is limited empirical evidence available to rehabilitation professionals to guide dose prescriptions for self-managed SLT despite their increasing use in the COVID-19 era and likely beyond. Objective: This study aims to leverage real-world mobile health data to investigate the effects of varied dosage frequency on performance outcomes for individuals with poststroke speech, language, and cognitive deficits following a 10-week period of self-managed treatment via a commercially available digital health platform. Methods: Anonymized data from 2249 poststroke survivors who used the Constant Therapy app between late 2016 and 2019 were analyzed. The data included therapy tasks spanning 13 different language and cognitive skill domains. For each patient, the weekly therapy dosage was calculated based on the median number of days per week of app use over the 10-week therapy period, binned into groups of 1, 2, 3, 4, or ≥5 days per week. Linear mixed-effects models were run to examine change in performance over time as a function of dosage group, with post hoc comparisons of slopes to evaluate the performance gain associated with each additional day of practice. Results: Across all skill domains, linear mixed-effects model results showed that performance improvement was significantly greater for patients who practiced 2 (β=.001; t15,355=2.37; P=.02), 3 (β=.003; t9738=5.21; P<.001), 4 (β=.005; t9289=7.82; P<.001), or ≥5 (β=.005; t6343=8.14; P<.001) days per week compared with those who only practiced for 1 day per week. Post hoc comparisons confirmed an incremental dosage effect accumulating with each day of practice (ie, 1 day vs 2 days, 2 days vs 3 days, and 3 days vs 4 days), apart from 4 days versus ≥5 days of practice per week. The result of greater improvement for higher versus lower dosage frequency groups was true not only across all domains but also within a majority of individual subdomains. Conclusions: The findings from this study demonstrated that increased dosage frequency is associated with greater therapy gains over a 10-week treatment period of self-managed digital therapy. The use of real-world data maximizes the ecological validity of study results and makes the findings more generalizable to clinical settings. This study represents an important step toward the development of optimal dose recommendations for self-managed SLT. %M 35857353 %R 10.2196/36135 %U https://www.jmir.org/2022/7/e36135 %U https://doi.org/10.2196/36135 %U http://www.ncbi.nlm.nih.gov/pubmed/35857353 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 7 %P e15055 %T Tweets Related to Motivation and Physical Activity for Obesity-Related Behavior Change: Descriptive Analysis %A Park,Albert %+ Department of Software and Information Systems, College of Computing and Informatics, University of North Carolina-Charlotte, Woodward 310H, 9201 University City Blvd, Charlotte, NC, 28223, United States, 1 704 687 8668, al.park@uncc.edu %K obesity %K motivation %K exercise %K peer support %K social network analysis %K social computing %K consumer health information %K informatics %K information science %K social support %K communications media %D 2022 %7 20.7.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Obesity is one of the greatest modern public health problems, due to the associated health and economic consequences. Decreased physical activity is one of the main societal changes driving the current obesity pandemic. Objective: Our goals are to fill a gap in the literature and study whether users organically utilize a social media platform, Twitter, for providing motivation. We examine the topics of messages and social network structures on Twitter. We discuss social media’s potential for providing peer support and then draw insights to inform the development of interventions for long-term health-related behavior change. Methods: We examined motivational messages related to physical activity on Twitter. First, we collected tweets related to physical activity. Second, we analyzed them using (1) a lexicon-based approach to extract and characterize motivation-related tweets, (2) a thematic analysis to examine common themes in retweets, and (3) topic models to understand prevalent factors concerning motivation and physical activity on Twitter. Third, we created 2 social networks to investigate organically arising peer-support network structures for sustaining physical activity and to form a deeper understanding of the feasibility of these networks in a real-world context. Results: We collected over 1.5 million physical activity–related tweets posted from August 30 to November 6, 2018. A relatively small percentage of the tweets mentioned the term motivation; many of these were made on Mondays or during morning or late morning hours. The analysis of retweets showed that the following three themes were commonly conveyed on the platform: (1) using a number of different types of motivation (self, process, consolation, mental, or quotes), (2) promoting individuals or groups, and (3) sharing or requesting information. Topic models revealed that many of these users were weightlifters or people trying to lose weight. Twitter users also naturally forged relations, even though 98.12% (2824/2878) of these users were in different physical locations. Conclusions: This study fills a knowledge gap on how individuals organically use social media to encourage and sustain physical activity. Elements related to peer support are found in the organic use of social media. Our findings suggest that geographical location is less important for providing peer support as long as the support provides motivation, despite users having few factors in common (eg, the weather) affecting their physical activity. This presents a unique opportunity to identify successful motivation-providing peer support groups in a large user base. However, further research on the effects in a real-world context, as well as additional design and usability features for improving user engagement, are warranted to develop a successful intervention counteracting the current obesity pandemic. This is especially important for young adults, the main user group for social media, as they develop lasting health-related behaviors. %M 35857347 %R 10.2196/15055 %U https://www.jmir.org/2022/7/e15055 %U https://doi.org/10.2196/15055 %U http://www.ncbi.nlm.nih.gov/pubmed/35857347 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 7 %P e34246 %T Effects of an Explicit Value Clarification Method With Computer-Tailored Advice on the Effectiveness of a Web-Based Smoking Cessation Decision Aid: Findings From a Randomized Controlled Trial %A Gültzow,Thomas %A Smit,Eline Suzanne %A Crutzen,Rik %A Jolani,Shahab %A Hoving,Ciska %A Dirksen,Carmen D %+ Department of Work & Social Psychology, Faculty of Psychology and Neuroscience, Maastricht University, PO Box 616, Maastricht, 6200 MD, Netherlands, 31 433881511, thomas.gultzow@maastrichtuniversity.nl %K digital health %K decision-making %K decision support technique %K decision aid %K smoking %K smoking cessation %K informed decision-making %K decision support %K decision support tool %K eHealth %K evidence-based medicine %K value clarification method %D 2022 %7 15.7.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Smoking continues to be a driver of mortality. Various forms of evidence-based cessation assistance exist; however, their use is limited. The choice between them may also induce decisional conflict. Offering decision aids (DAs) may be beneficial; however, insights into their effective elements are lacking. Objective: This study tested the added value of an effective element (ie, an “explicit value clarification method” paired with computer-tailored advice indicating the most fitting cessation assistance) of a web-based smoking cessation DA. Methods: A web-based randomized controlled trial was conducted among smokers motivated to stop smoking within 6 months. The intervention group received a DA with the aforementioned elements, and the control group received the same DA without these elements. The primary outcome measure was 7-day point prevalence abstinence 6 months after baseline (time point 3 [t=3]). Secondary outcome measures were 7-day point prevalence of abstinence 1 month after baseline (time point 2 [t=2]), evidence-based cessation assistance use (t=2 and t=3), and decisional conflict (immediately after DA; time point 1). Logistic and linear regression analyses were performed to assess the outcomes. Analyses were conducted following 2 (decisional conflict) and 3 (smoking cessation) outcome scenarios: complete cases, worst-case scenario (assuming that dropouts still smoked), and multiple imputations. A priori sample size calculation indicated that 796 participants were needed. The participants were mainly recruited on the web (eg, social media). All the data were self-reported. Results: Overall, 2375 participants were randomized (intervention n=1164, 49.01%), of whom 599 (25.22%; intervention n=275, 45.91%) completed the DAs, and 276 (11.62%; intervention n=143, 51.81%), 97 (4.08%; intervention n=54, 55.67%), and 103 (4.34%; intervention n=56, 54.37%) completed time point 1, t=2, and t=3, respectively. More participants stopped smoking in the intervention group (23/63, 37%) than in the control group (14/52, 27%) after 6 months; however, this was only statistically significant in the worst-case scenario (crude P=.02; adjusted P=.04). Effects on the secondary outcomes were only observed for smoking abstinence after 1 month (15/55, 27%, compared with 7/46, 15%, in the crude and adjusted models, respectively; P=.02) and for cessation assistance uptake after 1 month (26/56, 46% compared with 18/47, 38% only in the crude model; P=.04) and 6 months (38/61, 62% compared with 26/50, 52%; crude P=.01; adjusted P=.02) but only in the worst-case scenario. Nonuse attrition was 34.19% higher in the intervention group than in the control group (P<.001). Conclusions: Currently, we cannot confidently recommend the inclusion of explicit value clarification methods and computer-tailored advice. However, they might result in higher nonuse attrition rates, thereby limiting their potential. As a lack of statistical power may have influenced the outcomes, we recommend replicating this study with some adaptations based on the lessons learned. Trial Registration: Netherlands Trial Register NL8270; https://www.trialregister.nl/trial/8270 International Registered Report Identifier (IRRID): RR2-10.2196/21772 %M 35838773 %R 10.2196/34246 %U https://www.jmir.org/2022/7/e34246 %U https://doi.org/10.2196/34246 %U http://www.ncbi.nlm.nih.gov/pubmed/35838773 %0 Journal Article %@ 2562-7600 %I JMIR Publications %V 5 %N 1 %P e39263 %T Acceptability of an mHealth Family Self-management Intervention (myFAMI) for Pediatric Transplantation Families: Qualitative Focus %A Lerret,Stacee Marie %A Flynn,Erin %A White-Traut,Rosemary %A Alonso,Estella %A Mavis,Alisha M %A Jensen,M Kyle %A Peterson,Caitlin G %A Schiffman,Rachel %+ Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Medical College of Wisconsin, 8701 West Watertown Plank Road, Milwaukee, WI, 53226, United States, 1 414 266 3944, slerret@mcw.edu %K mHealth %K pediatric patients %K transplantation %K family self-management %K qualitative %D 2022 %7 15.7.2022 %9 Original Paper %J JMIR Nursing %G English %X Background: Around 1800 pediatric transplantations were performed in 2021, which is approximately 5% of the annual rate of solid organ transplantations carried out in the United States. Effective family self-management in the transition from hospital to home-based recovery promotes successful outcomes of transplantation. The use of mHealth to deliver self-management interventions is a strategy that can be used to support family self-management for transplantation recipients and their families. Objective: The study aims to evaluate the acceptability of an mHealth intervention (myFAMI) that combined use of a smartphone app with triggered nurse communication with family members of pediatric transplantation recipients. Methods: This is a secondary analysis of qualitative data from family members who received the myFAMI intervention within a larger randomized controlled trial. Eligible participants used the app in the 30-day time frame after discharge and participated in a 30-day postdischarge telephone interview. Content analysis was used to generate themes. Results: A total of 4 key themes were identified: (1) general acceptance, (2) positive interactions, (3) home management after hospital discharge, and (4) opportunities for improvement. Conclusions: Acceptability of the intervention was high. Family members rated the smartphone application as easy to use. myFAMI allowed the opportunity for families to feel connected to and engage with the medical team while in their home environment. Family members valued and appreciated ongoing support and education specifically in this first 30 days after their child’s hospital discharge and many felt it contributed positively to the management of their child’s medical needs at home. Family members provided recommendations for future refinement of the app and some suggested that a longer follow-up period would be beneficial. The development and refinement of mHealth care delivery strategies hold potential for improving outcomes for solid organ transplantation patients and their families and as a model to consider in other chronic illness populations. Trial Registration: ClinicalTrials.gov NCT03533049; https://clinicaltrials.gov/ct2/show/NCT03533049 %M 35838761 %R 10.2196/39263 %U https://nursing.jmir.org/2022/1/e39263 %U https://doi.org/10.2196/39263 %U http://www.ncbi.nlm.nih.gov/pubmed/35838761 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 7 %P e33911 %T Digital Facilitation to Support Patient Access to Web-Based Primary Care Services: Scoping Literature Review %A Leach,Brandi %A Parkinson,Sarah %A Gkousis,Evangelos %A Abel,Gary %A Atherton,Helen %A Campbell,John %A Clark,Christopher %A Cockcroft,Emma %A Marriott,Christine %A Pitchforth,Emma %A Sussex,Jon %+ RAND Europe, Westbrook Centre, Cambridge, CB41YG, United Kingdom, 44 1223353329, bleach@randeurope.org %K web-based health services %K primary care %K digital facilitation %D 2022 %7 14.7.2022 %9 Review %J J Med Internet Res %G English %X Background: The use of web-based services within primary care (PC) in the National Health Service in England is increasing, with medically underserved populations being less likely to engage with web-based services than other patient groups. Digital facilitation—referring to a range of processes, procedures, and personnel that seek to support patients in the uptake and use of web-based services—may be a way of addressing these challenges. However, the models and impact of digital facilitation currently in use are unclear. Objective: This study aimed to identify, characterize, and differentiate between different approaches to digital facilitation in PC; establish what is known about the effectiveness of different approaches; and understand the enablers of digital facilitation. Methods: Adopting scoping review methodology, we searched academic databases (PubMed, EMBASE, CINAHL, Web of Science, and Cochrane Library) and gray literature published between 2015 and 2020. We conducted snowball searches of reference lists of included articles and articles identified during screening as relevant to digital facilitation, but which did not meet the inclusion criteria because of article type restrictions. Titles and abstracts were independently screened by 2 reviewers. Data from eligible studies were analyzed using a narrative synthesis approach. Results: A total of 85 publications were included. Most (71/85, 84%) were concerned with digital facilitation approaches targeted at patients (promotion of services, training patients to improve their technical skills, or other guidance and support). Further identified approaches targeted PC staff to help patients (eg, improving staff knowledge of web-based services and enhancing their technical or communication skills). Qualitative evidence suggests that some digital facilitation may be effective in promoting the uptake and use of web-based services by patients (eg, recommendation of web-based services by practice staff and coaching). We found little evidence that providing patients with initial assistance in registering for or accessing web-based services leads to increased long-term use. Few studies have addressed the effects of digital facilitation on health care inequalities. Those that addressed this suggested that providing technical training for patients could be effective, at least in part, in reducing inequalities, although not entirely. Factors affecting the success of digital facilitation include perceptions of the usefulness of the web-based service, trust in the service, patients’ trust in providers, the capacity of PC staff, guidelines or regulations supporting facilitation efforts, and staff buy-in and motivation. Conclusions: Digital facilitation has the potential to increase the uptake and use of web-based services by PC patients. Understanding the approaches that are most effective and cost-effective, for whom, and under what circumstances requires further research, including rigorous evaluations of longer-term impacts. As efforts continue to increase the use of web-based services in PC in England and elsewhere, we offer an early typology to inform conceptual development and evaluations. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020189019; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=189019 %M 35834301 %R 10.2196/33911 %U https://www.jmir.org/2022/7/e33911 %U https://doi.org/10.2196/33911 %U http://www.ncbi.nlm.nih.gov/pubmed/35834301 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 8 %N 7 %P e34277 %T Effects of an mHealth Intervention for Pulmonary Tuberculosis Self-management Based on the Integrated Theory of Health Behavior Change: Randomized Controlled Trial %A Bao,Yuhan %A Wang,Chunxiang %A Xu,Haiping %A Lai,Yongjie %A Yan,Yupei %A Ma,Yuanyuan %A Yu,Ting %A Wu,Yibo %+ School of Public Health, Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China, 86 18810169630, bjmuwuyibo@outlook.com %K ITHBC %K mHealth %K RCT %K pulmonary tuberculosis %D 2022 %7 14.7.2022 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: Improving the health self-management level of patients with tuberculosis (TB) is significant for reducing drug resistance, improving the cure rate, and controlling the prevalence of TB. Mobile health (mHealth) interventions based on behavioral science theories may be promising to achieve this goal. Objective: This study aims to explore and conduct an mHealth intervention based on the Integrated Theory of Health Behavior Change (ITHBC) in patients with pulmonary TB to increase their ability of self-care management. Methods: A prospective randomized controlled study was conducted from May to November 2020. A total of 114 patients who were admitted consecutively to the TB clinic of Harbin Chest Hospital, China from May 2020 to August 2020 were recruited by convenience sampling. Patients were divided into the control group and intervention group, and all received a 3-month intervention. Patients in the intervention group and the control group received routine medical and nursing care in the TB clinic, including the supervision of their medications. In addition, pharmacist-assisted mHealth (WeChat) intervention based on the ITHBC theory about TB management was provided to the intervention group. The primary outcome was self-management behavior, while the secondary outcomes were TB awareness, self-efficacy, social support, and degree of satisfaction with health education. The outcomes were measured using web-based self-designed and standard questionnaires administered at baseline and at the end point of the study. Intergroup data were assessed using the Mann-Whitney U test, whereas intragroup data were assessed with the Wilcoxon test (for paired samples). Results: A total of 112 patients (59 in intervention group and 53 in control group) completed the study. After the intervention, a statistically significant increase was noted in the scores of each item of self-care management behaviors compared with the scores at the baseline (P<.001) in the intervention group. The scores of all self-care management behaviors of the control group were lower than those of all self-care management behaviors in the intervention group (all P<.05), except for the item “cover your mouth and nose when coughing or sneezing” (P=.23) and item “wash hands properly” (P=.60), which had no statistically significant difference from those in the intervention group. Compared with those at baseline, TB knowledge awareness, self-efficacy, social support, and degree of satisfaction with health education in the intervention group increased significantly (P<.001), and the intervention group had significantly higher scores than the control group (P<.001). Conclusions: mHealth intervention for TB self-management based on ITHBC could deepen the understanding of patients with TB about their disease and improve their objective initiative and self-care management behaviors, which were beneficial for promoting compliance behavior and quality of prevention and control for pulmonary TB. Trial Registration: Chinese Clinical Trial Registry ChiCTR2200055557; https://tinyurl.com/4ray3xnw %M 35834302 %R 10.2196/34277 %U https://publichealth.jmir.org/2022/7/e34277 %U https://doi.org/10.2196/34277 %U http://www.ncbi.nlm.nih.gov/pubmed/35834302 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 7 %P e26569 %T A Technology-Assisted Telephone Intervention for Work-Related Stress Management: Pilot Randomized Controlled Trial %A Muuraiskangas,Salla Tuulikki %A Honka,Anita Marianne %A Junno,Ulla-Maija %A Nieminen,Hannu Olavi %A Kaartinen,Jouni Kalevi %+ Smart Health, VTT Technical Research Centre of Finland Ltd, Kaitoväylä 1, Oulu, 90590, Finland, 358 408350169, salla.muuraiskangas@gmail.com %K health behavior change intervention %K telephone coaching %K technology-assisted coaching %K remote coaching %K occupational health %K mental well-being %K stress management %K feasibility %K randomized controlled trial %D 2022 %7 13.7.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Stress management interventions combining technology with human involvement have the potential to improve the cost-effectiveness of solely human-delivered interventions, but few randomized controlled trials exist for assessing the cost-effectiveness of technology-assisted human interventions. Objective: The aim of this study was to investigate whether a technology-assisted telephone intervention for stress management is feasible for increasing mental well-being or decreasing the time use of coaches (as an approximation of intervention cost) while maintaining participants’ adherence and satisfaction compared with traditional telephone coaching. Methods: A 2-arm, pilot randomized controlled trial of 9 months for stress management (4-month intensive and 5-month maintenance phases) was conducted. Participants were recruited on the web through a regional occupational health care provider and randomized equally to a research (technology-assisted telephone intervention) and a control (traditional telephone intervention) group. The coaching methodology was based on habit formation, motivational interviewing, and the transtheoretical model. For the research group, technology supported both coaches and participants in identifying behavior change targets, setting the initial coaching plan, monitoring progress, and communication. The pilot outcome was intervention feasibility, measured primarily by self-assessed mental well-being (WorkOptimum index) and self-reported time use of coaches and secondarily by participants’ adherence and satisfaction. Results: A total of 49 eligible participants were randomized to the research (n=24) and control (n=25) groups. Most participants were middle-aged (mean 46.26, SD 9.74 years) and female (47/49, 96%). Mental well-being improved significantly in both groups (WorkOptimum from “at risk” to “good” Â>0.85; P<.001), and no between-group differences were observed in the end (Â=0.56, 95% CI 0.37-0.74; P=.56). The total time use of coaches did not differ significantly between the groups (366.0 vs 343.0 minutes, Â=0.60, 95% CI 0.33-0.85; P=.48). Regarding adherence, the dropout rate was 13% (3/24) and 24% (6/25), and the mean adherence rate to coaching calls was 92% and 86% for the research and control groups, respectively; the frequency of performing coaching tasks was similar for both groups after both phases; and the diligence in performing the tasks during the intensive phase was better for the research group (5.0 vs 4.0, Â=0.58, 95% CI 0.51-0.65; P=.03), but no difference was observed during the maintenance phase. Satisfaction was higher in the research group during the intensive phase (5.0 vs 4.0, Â=0.66, 95% CI 0.58-0.73; P<.001) but not during the maintenance phase. Conclusions: The technology-assisted telephone intervention is feasible with some modifications, as it had similar preliminary effectiveness as the traditional telephone intervention, and the participants had better satisfaction with and similar or better adherence to the intervention, but it did not reduce the time use of coaches. The technology should be improved to provide more digested information for action planning and templates for messaging. Trial Registration: ClinicalTrials.gov NCT02445950; https://www.clinicaltrials.gov/ct2/show/study/NCT02445950 %M 35830233 %R 10.2196/26569 %U https://www.jmir.org/2022/7/e26569 %U https://doi.org/10.2196/26569 %U http://www.ncbi.nlm.nih.gov/pubmed/35830233 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 7 %P e38735 %T Implementation of a Statewide Web-Based Caregiver Resource Information System (CareNav): Mixed Methods Study %A Young,Heather M %A Bell,Janice F %A Tonkikh,Orly %A Kilaberia,Tina R %A Whitney,Robin L %A Mongoven,Jennifer M %A Link,Benjamin M %A Kelly,Kathleen %+ Family Caregiving Institute, Betty Irene Moore School of Nursing, University of California Davis, Betty Irene Moore Hall, 2570 48th St, Sacramento, CA, 95817, United States, 1 541 261 0395, hmyoung@ucdavis.edu %K online assessment %K caregiver %K technology implementation %K Consolidated Framework for Implementation Research %K CFIR %D 2022 %7 13.7.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: With the aging population, family caregivers provide increasingly complex and intense care for older adults and persons with disabilities. There is growing interest in developing community-based services to support family caregivers. Caregiving occurs around the clock, and caregivers face challenges in accessing community-based services at convenient times owing to the demands of care. Web-based resources hold promise for accessible real-time support. CareNav (TM), a caregiver resource information system, is a web-based platform designed to support real-time universal caregiver assessment, a record of client encounters, development of a care plan, tailored information and resource content, access to web-based caregiver resources, the capacity to track service authorization and contracts, and secure communications. The assessment includes needs and health conditions of both the care recipient and caregiver; current resources; and priorities for support, information, and referral. In 2019, the California Department of Health Care Services funded the 11 nonprofit California Caregiver Resource Centers (CRCs) to expand and improve family caregiver services and enhance CRC information technology services. Deployment of a statewide information system offered a unique opportunity to examine structures and processes facilitating implementation, providing feedback to the sites as well as lessons learned for similar projects in the future. Objective: The aim of this paper was to describe the statewide implementation of the comprehensive CareNav system using the Consolidated Framework for Implementation Research as an organizing structure for synthesizing the evaluation. Methods: This mixed methods study used two major approaches to evaluate the implementation process: a survey of all staff who completed training (n=82) and in-depth qualitative interviews with 11 CRC teams and 3 key informants (n=35). We initially analyzed interview transcripts using qualitative descriptive methods and then identified subthemes and relationships among ideas, mapping the findings to the Consolidated Framework for Implementation Research. Results: We present findings on the outer setting, inner setting, characteristics of the intervention, characteristics of the staff, and the implementation process. The critical elements for success were leadership, communication, harmonization of processes across sites, and motivation to serve clients in more accessible and convenient ways. Conclusions: These findings have implications for technology deployment in diverse community-based agencies that aspire to enhance web-based services. %M 35830234 %R 10.2196/38735 %U https://formative.jmir.org/2022/7/e38735 %U https://doi.org/10.2196/38735 %U http://www.ncbi.nlm.nih.gov/pubmed/35830234 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 7 %P e36018 %T Improving Well-being With a Mobile Artificial Intelligence–Powered Acceptance Commitment Therapy Tool: Pragmatic Retrospective Study %A Naor,Navot %A Frenkel,Alex %A Winsberg,Mirène %+ Kai.ai, Yigal Alon St 114, Tel Aviv, 6744320, Israel, 972 502183965, navot@kai.ai %K Acceptance Commitment Therapy %K well-being %K WHO-5 %K World Health Organization-Five Well-Being Index %K mHealth %K mobile health %K smartphone %K health application %K mental health %K quality of life %K artificial intelligence %D 2022 %7 12.7.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Research and dissemination of smartphone apps to deliver coaching and psychological driven intervention had seen a great surge in recent years. Notably, Acceptance Commitment Therapy (ACT) protocols were shown to be uniquely effective in treating symptoms for both depression and anxiety when delivered through smartphone apps. The aim of this study is to expand on that work and test the suitability of artificial intelligence–driven interventions delivered directly through popular texting apps. Objective: This study evaluated our hypothesis that using Kai.ai will result in improved well-being. Methods: We performed a pragmatic retrospective analysis of 2909 users who used Kai.ai on one of the top messaging apps (iMessage, WhatsApp, Discord, Telegram, etc). Users’ well-being levels were tracked using the World Health Organization-Five Well-Being Index throughout the engagement with service. A 1-tailed paired samples t test was used to assess well-being levels before and after usage, and hierarchical linear modeling was used to examine the change in symptoms over time. Results: The median well-being score at the last measurement was higher (median 52) than that at the start of the intervention (median 40), indicating a significant improvement (W=2682927; P<.001). Furthermore, HLM results showed that the improvement in well-being was linearly related to the number of daily messages a user sent (β=.029; t81.36=4; P<.001), as well as the interaction between the number of messages and unique number of days (β=–.0003; t81.36=–2.2; P=.03). Conclusions: Mobile-based ACT interventions are effective means to improve individuals’ well-being. Our findings further demonstrate Kai.ai’s great promise in helping individuals improve and maintain high levels of well-being and thus improve their daily lives. %M 35598216 %R 10.2196/36018 %U https://formative.jmir.org/2022/7/e36018 %U https://doi.org/10.2196/36018 %U http://www.ncbi.nlm.nih.gov/pubmed/35598216 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 8 %N 3 %P e36255 %T Web-Based Psychological Interventions for People Living With and Beyond Cancer: Meta-Review of What Works and What Does Not for Maximizing Recruitment, Engagement, and Efficacy %A Leslie,Monica %A Beatty,Lisa %A Hulbert-Williams,Lee %A Pendrous,Rosina %A Cartwright,Tim %A Jackson,Richard %A , %A Hulbert-Williams,Nicholas J %+ Department of Psychology, Edge Hill University, St Helens Road, Ormskirk, L39 4QP, United Kingdom, 44 01695 657684, hulbertwn@edgehill.ac.uk %K cancer %K neoplasms %K survivors %K psychosocial oncology %K internet-based intervention %K psychosocial intervention %D 2022 %7 8.7.2022 %9 Review %J JMIR Cancer %G English %X Background: Despite high levels of psychological distress experienced by many patients with cancer, previous research has identified several barriers to accessing traditional face-to-face psychological support. Web-based psychosocial interventions have emerged as a promising alternative. Objective: This meta-review aimed to synthesize evidence on recruitment challenges and enablers, factors that promote engagement and adherence to web-based intervention content, and factors that promote the efficacy of web-based psychosocial interventions for patients with cancer and cancer survivors. Methods: We conducted a systematic search of previous reviews that investigated the recruitment, engagement, and efficacy of web-based and app-based psychosocial interventions in adult patients with cancer and cancer survivors. We searched PubMed, CINAHL, PsycINFO, and the Cochrane Library database for relevant literature. The search terms focused on a combination of topics pertaining to neoplasms and telemedicine. Two independent authors conducted abstract screening, full text screening, and data extraction for each identified article. Results: A total of 20 articles met eligibility criteria. There was inconsistency in the reporting of uptake and engagement data; however, anxiety about technology and perceived time burden were identified as 2 key barriers. Web-based psychosocial oncology interventions demonstrated efficacy in reducing depression and stress but reported weak to mixed findings for distress, anxiety, quality of life, and well-being. Although no factors consistently moderated intervention efficacy, preliminary evidence indicated that multicomponent interventions and greater communication with a health care professional were preferred by participants and were associated with superior effects. Conclusions: Several consistently cited barriers to intervention uptake and recruitment have emerged, which we recommend future intervention studies address. Preliminary evidence also supports the superior efficacy of multicomponent interventions and interventions that facilitate communication with a health care professional. However, a greater number of appropriately powered clinical trials, including randomized trials with head-to-head comparisons, are needed to enable more confident conclusions regarding which web-based psychosocial oncology interventions work best and for whom. Trial Registration: PROSPERO CRD42020202633; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=202633 %M 35802418 %R 10.2196/36255 %U https://cancer.jmir.org/2022/3/e36255 %U https://doi.org/10.2196/36255 %U http://www.ncbi.nlm.nih.gov/pubmed/35802418 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 5 %N 3 %P e33085 %T mHealth Interventions to Support Caregivers of Older Adults: Equity-Focused Systematic Review %A Garnett,Anna %A Northwood,Melissa %A Ting,Justine %A Sangrar,Ruheena %+ Arthur Labatt Family School of Nursing, Western University, FIMS & Nursing Building, Rm 2306, London, ON, N6A 5B9, Canada, 1 519 661 2111, agarnet6@uwo.ca %K caregivers %K older adults %K mobile health %K social determinants of health %K intervention %K mobile phone %D 2022 %7 8.7.2022 %9 Review %J JMIR Aging %G English %X Background: Informal caregivers, hereafter referred to as caregivers, provide support to older adults so that they can age safely at home. The decision to become a caregiver can be influenced by individual factors, such as personal choice, or societal factors such as social determinants of health, including household income, employment status, and culture-specific gender roles. Over time, caregivers’ health can be negatively affected by their caregiving roles. Although programs exist to support caregivers, the availability and appropriateness of services do not match caregivers’ expressed needs. Research suggests that supportive interventions offered through mobile health (mHealth) technologies have the potential to increase caregivers’ access to supportive services. However, a knowledge gap remains regarding the extent to which social determinants of health are considered in the design, implementation, and evaluation of mHealth interventions intended to support the caregivers of older adults. Objective: This study aimed to conduct a systematic review to determine how health equity is considered in the design, implementation, and evaluation of mHealth interventions for caregivers of older adults using Cochrane Equity’s PROGRESS-Plus (place of residence, race, ethnicity, culture, language, occupation, gender, religion, education, social capital, socioeconomic status–plus age, disability, and sexual orientation) framework and synthesize evidence of the impacts of the identified caregiver-focused mHealth interventions. Methods: A systematic review was conducted using 5 databases. Articles published between January 2010 and June 2021 were included if they evaluated or explored the impact of mHealth interventions on the health and well-being of informal caregivers of older adults. mHealth interventions were defined as supportive services, for example, education, that caregivers of older adults accessed via mobile or wireless devices. Results: In total, 28 articles met the inclusion criteria and were included in the review. The interventions evaluated sought to connect caregivers with services, facilitate caregiving, and promote caregivers’ health and well-being. The PROGRESS-Plus framework factors were mainly considered in the results, discussion, and limitations sections of the included studies. Some PROGRESS-Plus factors such as sexual orientation, religion, and occupation, received little to no consideration across any phase of the intervention design, implementation, or evaluation. Overall, the findings of this review suggest that mHealth interventions were positively received by study participants. Such interventions have the potential to reduce caregiver burden and positively affect caregivers’ physical and mental health while supporting them as caregivers. The study findings highlight the importance of making support available to help facilitate caregivers’ use of mHealth interventions, as well as in the use of appropriate language and text. Conclusions: The successful uptake and spread of mHealth interventions to support caregivers of older adults will depend on creating opportunities for the inclusive involvement of a broad range of stakeholders at all stages of design, implementation, and evaluation. %M 35616514 %R 10.2196/33085 %U https://aging.jmir.org/2022/3/e33085 %U https://doi.org/10.2196/33085 %U http://www.ncbi.nlm.nih.gov/pubmed/35616514 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 7 %P e33978 %T Developing Educational Animations on HIV Pre-exposure Prophylaxis (PrEP) for Women: Qualitative Study %A Young,Anna Marie %A Fruhauf,Timothee %A Okonkwo,Obianuju %A Gingher,Erin %A Coleman,Jenell %+ Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, 600 N Wolfe Street, Phipps Room 254A, Baltimore, MD, United States, 1 410 614 4496, colemanj@jhmi.edu %K PrEP %K animations %K education %K HIV %K prevention %K women %D 2022 %7 8.7.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Despite experiencing the second-highest rate of HIV incidence in the United States, pre-exposure prophylaxis (PrEP) use remains low among Black women due, in part, to a lack of patients’ awareness and providers’ knowledge. Objective: Our goal was to design animated educational tools informed by patients and women’s health providers to address these barriers, specifically for women at risk for HIV. Methods: Two animation storyboards about PrEP for women were created by academic stakeholders (eg, HIV clinical experts, educators, and HIV peer counselors), one for patients and one for providers. Four focus groups with community members from Baltimore, Maryland and four with women’s health providers (eg, obstetrician/gynecologists, midwives, nurse practitioners, and peer counselors) at an academic center were conducted to discuss the storyboards. Transcripts were analyzed using conventional content analysis, and themes were incorporated into the final versions of the animations. Results: Academic stakeholders and 30 focus group participants (n=16 female community members and n=14 women’s health providers) described important themes regarding PrEP. The themes most commonly discussed about the patient animation were understandability of side effects, HIV risk factors, messaging, PrEP access, and use confidence. Provider animation themes were indications for PrEP, side effects, and prescribing confidence. Conclusions: We created two PrEP animations focused on women. Stakeholder feedback highlighted the importance of ensuring the understandability and applicability of PrEP educational materials while including necessary information to facilitate use or prescribing confidence. Both community members and women’s health providers reported greater use confidence after viewing the animations. %M 35802416 %R 10.2196/33978 %U https://formative.jmir.org/2022/7/e33978 %U https://doi.org/10.2196/33978 %U http://www.ncbi.nlm.nih.gov/pubmed/35802416 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 7 %P e38595 %T Behavioral Change Factors and Retention in Web-Based Interventions for Informal Caregivers of People Living With Dementia: Scoping Review %A Wu,Kuan-Ching %A Su,Yan %A Chu,Frances %A Chen,Annie T %A Zaslavsky,Oleg %+ School of Nursing, University of Washington, 1959 NE Pacific St,, Seattle, WA, 98195, United States, 1 2065438736, kuancw@uw.edu %K dementia %K informal caregivers %K informal care %K caregiving %K retention %K internet %K web-based %K behavior %K intervention %K review %K scoping %K health intervention %K digital health %K caregiver %K psychological health %K cognition %K peer support %K web-based intervention %K taxonomy %K aging %K gerontology %K older adult population %K neurological disorder %K behavior change technique %K BCT %K change technique %D 2022 %7 7.7.2022 %9 Review %J J Med Internet Res %G English %X Background: Web-based interventions aimed at supporting informal caregivers of people living with dementia have the potential to improve caregivers’ well-being and psychological health. However, few interventions are widely implemented for this population, and none of the prior reviews have systematically examined the use of behavior change techniques (BCTs), theories, and agents in web-based interventions for informal caregivers of people living with dementia. To better understand this implementation gap, we reviewed the literature to map behavioral factors (BCTs, theories, and agents) deployed in the studies. Furthermore, because there is an emerging consensus that retention could be shaped by participant characteristics and behavioral factors, we explored relationships between these features and retention rates across studies. Objective: We pursued 3 objectives: to map behavioral factors involved in the web-based interventions for informal caregivers of people living with dementia; to examine the relationship between behavioral change elements and retention in the studies; and to examine the relationship between participant characteristics (gender, age, and spouse or adult children caregiver proportion) and study retention. Methods: We conducted a literature review using the following keywords and their corresponding Medical Subject Headings terms: dementia, caregivers, and web-based intervention. The time limits were January 1998 to March 2022. Using the BCTv1 taxonomy, which specifies active behavioral components in interventions, 2 coders collected, summarized, and analyzed the frequency distributions of BCTs. Similarly, they abstracted and analyzed participant characteristics, behavior change theories, behavior change agents, and retention rates in the studies. Results: The average age was 61.5 (SD 7.4) years, and the average proportion of spousal informal caregivers, adult children informal caregivers, and retention rates were 51.2% (SD 24.8%), 44.8% (SD 22%), and 70.4% (SD 17%), respectively. Only 53% (17/32) of the studies used behavior change theories, but 81% (26/32) included behavior change agents. The most common BCTv1 clusters were shaping knowledge and social support. The median number of BCTv1 clusters was 5 (IQR 3). We observed a negative correlation between the proportion of spousal informal caregivers and the retention rate (r=−0.45; P=.02) and between the number of BCTv1 clusters and retention rates (r=−0.47; P=.01). We also found that the proportion of adult children informal caregivers in the study was significantly and positively correlated with the retention rate (r=0.5; P=.03). No other participant characteristics or behavioral factors were associated with retention rates. Conclusions: We found that almost half of the studies were not informed by behavior change theories. In addition, spousal involvement and a higher number of BCTs were each associated with lower retention rates, while the involvement of adult children caregivers in the study was associated with higher retention. In planning future studies, researchers should consider matching participant characteristics with their intended intervention as the alignment might improve their retention rates. %M 35797100 %R 10.2196/38595 %U https://www.jmir.org/2022/7/e38595 %U https://doi.org/10.2196/38595 %U http://www.ncbi.nlm.nih.gov/pubmed/35797100 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 7 %P e37600 %T Pilot Implementation of a User-Driven, Web-Based Application Designed to Improve Sexual Health Knowledge and Communication Among Young Zambians: Mixed Methods Study %A Sharma,Anjali %A Mwamba,Chanda %A Ng'andu,Mwila %A Kamanga,Vikwato %A Zoonadi Mendamenda,Mayamiko %A Azgad,Yael %A Jabbie,Zainab %A Chipungu,Jenala %A Pry,Jake M %+ Department of Public Health Sciences, University of California, Medical Sciences 1-C, One Shield's Ave, Davis, CA, 95616, United States, 1 9366616885, Jmpry@ucdavis.edu %K sexual and reproductive health %K web application %K digital health intervention %K pilot study %K quasi-experiment %K adolescent %K young people %K Zambia %K sub-Saharan Africa %K mobile phone %D 2022 %7 7.7.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital health interventions show promise in improving the uptake of HIV services among adolescents and young people aged 15 to 24 years in sub-Saharan Africa. Objective: This study aimed to pilot-test a theory-based, empirically grounded web-based application designed to increase condom-related knowledge, sexual and reproductive health (SRH) communication, and healthier choices among young Zambians. Methods: We conducted a pre-post quasi-experimental evaluation of the user-driven Be in the Know Zambia (BITKZ) web application using web-based surveys and in-depth interviews (IDIs) on the phone. We enrolled participants using social media advertisements. Our final analysis set comprised 46.04% (749/1627) of participants in the intervention group (which received the BITKZ link) and 53.96% (878/1627) of participants in the comparison group (no intervention). We collected survey data at study enrollment (baseline) and 5 weeks after the first enrollment in each group. Approximately 85% (637/749) of BITKZ users completed a user survey, of whom 9.3% (59/637) participated in IDIs. We calculated the time interfacing with BITKZ using the application log files. We conducted descriptive analyses to describe baseline characteristics and the user experience. At the endline, we assessed association using a t test and adjusted logistic regression for binary outcomes and ordinal regression for ordered outcomes, conditioning on age, sex, marital status, and employment status. We used adjusted average treatment effects (aATE) to assess the effects of BITKZ intervention. We conducted rapid matrix analyses of IDI transcripts in Microsoft Excel, sorting the data by theme, gender, and experience rating. Results: Users rated BITKZ highly (excellent: 352/609, 57.8%; good: 218/609, 35.8%). At the endline, the intervention group had a higher level of knowledge related to condoms (adjusted odds ratio [aOR]: 1.35, 95% CI 1.06-1.69) and on wearing condoms correctly (aOR: 1.23, 95% CI 1.02-1.49). Those who had full-time employment had increased odds of knowing how to wear condoms correctly (aOR: 1.67, 95% CI 1.06-2.63) compared with those who reported being unemployed, as did men when compared with women (aOR: 1.92, 95% CI 1.59-2.31). Those in the intervention group were more likely to score higher for intention to test for sexually transmitted infections (STIs; aATE 0.21; P=.01) and HIV (aATE 0.32; P=.05), as well as for resisting peer pressure (aATE 2.64; P=.02). IDIs corroborated increased knowledge on correct condom use among men and female condoms among women, awareness of STIs and testing, and resistance to peer pressure. Interviewees provided examples of more open SRH communication with partners and peers and of considering, adopting, and influencing others to adopt healthier behaviors. Conclusions: Despite the high baseline awareness of SRH among Zambian adolescents and young people with internet access, BITKZ provided modest gains in condom-related knowledge, resistance to peer pressure, and intention to test for STIs and HIV. %M 35797099 %R 10.2196/37600 %U https://www.jmir.org/2022/7/e37600 %U https://doi.org/10.2196/37600 %U http://www.ncbi.nlm.nih.gov/pubmed/35797099 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 7 %P e32487 %T The Effect of a Future-Self Avatar Mobile Health Intervention (FutureMe) on Physical Activity and Food Purchases: Randomized Controlled Trial %A Mönninghoff,Annette %A Fuchs,Klaus %A Wu,Jing %A Albert,Jan %A Mayer,Simon %+ Institute for Mobility, University of St. Gallen, Bahnhofstrasse 8, St Gallen, 9000, Switzerland, 41 712242132, Annette.Moenninghoff@unisg.ch %K mHealth %K mobile health %K preventative medicine %K avatar %K present bias %K nutrition tracking %K physical activity %K randomized controlled trial %D 2022 %7 7.7.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Insufficient physical activity and unhealthy diets are contributing to the rise in noncommunicable diseases. Preventative mobile health (mHealth) interventions may help reverse this trend, but present bias might reduce their effectiveness. Future-self avatar interventions have resulted in behavior change in related fields, yet evidence of whether such interventions can change health behavior is lacking. Objective: We aimed to investigate the impact of a future-self avatar mHealth intervention on physical activity and food purchasing behavior and examine the feasibility of a novel automated nutrition tracking system. We also aimed to understand how this intervention impacts related attitudinal and motivational constructs. Methods: We conducted a 12-week parallel randomized controlled trial (RCT), followed by semistructured interviews. German-speaking smartphone users aged ≥18 years living in Switzerland and using at least one of the two leading Swiss grocery loyalty cards, were recruited for the trial. Data were collected from November 2020 to April 2021. The intervention group received the FutureMe intervention, a physical activity and food purchase tracking mobile phone app that uses a future-self avatar as the primary interface and provides participants with personalized food basket analysis and shopping tips. The control group received a conventional text- and graphic-based primary interface intervention. We pioneered a novel system to track nutrition by leveraging digital receipts from loyalty card data and analyzing food purchases in a fully automated way. Data were consolidated in 4-week intervals, and nonparametric tests were conducted to test for within- and between-group differences. Results: We recruited 167 participants, and 95 eligible participants were randomized into either the intervention (n=42) or control group (n=53). The median age was 44 years (IQR 19), and the gender ratio was balanced (female 52/95, 55%). Attrition was unexpectedly high with only 30 participants completing the intervention, negatively impacting the statistical power. The FutureMe intervention led to small statistically insignificant increases in physical activity (median +242 steps/day) and small insignificant improvements in the nutritional quality of food purchases (median −1.28 British Food Standards Agency Nutrient Profiling System Dietary Index points) at the end of the intervention. Intrinsic motivation significantly increased (P=.03) in the FutureMe group, but decreased in the control group. Outcome expectancy directionally increased in the FutureMe group, but decreased in the control group. Leveraging loyalty card data to track the nutritional quality of food purchases was found to be a feasible and accepted fully automated nutrition tracking system. Conclusions: Preventative future-self avatar mHealth interventions promise to encourage improvements in physical activity and food purchasing behavior in healthy population groups. A full-powered RCT is needed to confirm this preliminary evidence and to investigate how future-self avatars might be modified to reduce attrition, overcome present bias, and promote sustainable behavior change. Trial Registration: ClinicalTrials.gov NCT04505124; https://clinicaltrials.gov/ct2/show/NCT04505124 %M 35797104 %R 10.2196/32487 %U https://www.jmir.org/2022/7/e32487 %U https://doi.org/10.2196/32487 %U http://www.ncbi.nlm.nih.gov/pubmed/35797104 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 7 %P e36869 %T Exploring Users’ Experiences With a Quick-Response Chatbot Within a Popular Smoking Cessation Smartphone App: Semistructured Interview Study %A Alphonse,Alice %A Stewart,Kezia %A Brown,Jamie %A Perski,Olga %+ Department of Behavioural Science and Health, University College London, 1-19 Torrington Place, London, WC1E 7HB, United Kingdom, 44 0207679 ext 1258, olga.perski@ucl.ac.uk %K chatbot %K conversational agent %K engagement %K smartphone app %K smoking cessation %K accountability %K mobile phone %D 2022 %7 7.7.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Engagement with smartphone apps for smoking cessation tends to be low. Chatbots (ie, software that enables conversations with users) offer a promising means of increasing engagement. Objective: We aimed to explore smokers’ experiences with a quick-response chatbot (Quit Coach) implemented within a popular smoking cessation app and identify factors that influence users’ engagement with Quit Coach. Methods: In-depth, one-to-one, semistructured qualitative interviews were conducted with adult, past-year smokers who had voluntarily used Quit Coach in a recent smoking cessation attempt (5/14, 36%) and current smokers who agreed to download and use Quit Coach for a minimum of 2 weeks to support a new cessation attempt (9/14, 64%). Verbal reports were audio recorded, transcribed verbatim, and analyzed within a constructivist theoretical framework using inductive thematic analysis. Results: A total of 3 high-order themes were generated to capture users’ experiences and engagement with Quit Coach: anthropomorphism of and accountability to Quit Coach (ie, users ascribing human-like characteristics and thoughts to the chatbot, which helped foster a sense of accountability to it), Quit Coach’s interaction style and format (eg, positive and motivational tone of voice and quick and easy-to-complete check-ins), and users’ perceived need for support (ie, chatbot engagement was motivated by seeking distraction from cravings or support to maintain motivation to stay quit). Conclusions: Anthropomorphism of a quick-response chatbot implemented within a popular smoking cessation app appeared to be enabled by its interaction style and format and users’ perceived need for support, which may have given rise to feelings of accountability and increased engagement. %M 35797093 %R 10.2196/36869 %U https://formative.jmir.org/2022/7/e36869 %U https://doi.org/10.2196/36869 %U http://www.ncbi.nlm.nih.gov/pubmed/35797093 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 7 %P e38243 %T The Effect of Tailored, Daily, Smartphone Feedback to Lifestyle Self-Monitoring on Weight Loss at 12 Months: the SMARTER Randomized Clinical Trial %A Burke,Lora E %A Sereika,Susan M %A Bizhanova,Zhadyra %A Parmanto,Bambang %A Kariuki,Jacob %A Cheng,Jessica %A Beatrice,Britney %A Cedillo,Maribel %A Pulantara,I Wayan %A Wang,Yuhan %A Loar,India %A Conroy,Molly B %+ School of Nursing, University of Pittsburgh, 3500 Victoria St, Pittsburgh, PA, 15261, United States, 1 412 779 0555, lbu100@pitt.edu %K self-monitoring %K behavioral intervention/weight loss %K feedback messages %K engagement %K mHealth %K adherence %K obesity %K randomized clinical trial %K smart scales %K physical activity trackers %K digital health %D 2022 %7 5.7.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Self-monitoring (SM) is the centerpiece of behavioral weight loss treatment, but the efficacy of smartphone-delivered SM feedback (FB) has not been tested in large, long-term, randomized trials. Objective: The aim of this study was to establish the efficacy of providing remote FB to diet, physical activity (PA), and weight SM on improving weight loss outcomes when comparing the SM plus FB (SM+FB) condition to the SM-only condition in a 12-month randomized controlled trial. The study was a single-site, population-based trial that took place in southwestern Pennsylvania, USA, conducted between 2018 and 2021. Participants were smartphone users age ≥18 years, able to engage in moderate PA, with a mean BMI between 27 and 43 kg/m2. Methods: All participants received a 90-minute, one-to-one, in-person behavioral weight loss counseling session addressing behavioral strategies, establishing participants’ dietary and PA goals, and instructing on use of the PA tracker (Fitbit Charge 2), smart scale, and diet SM app. Only SM+FB participants had access to an investigator-developed smartphone app that read SM data, in which an algorithm selected tailored messages sent to the smartphone up to 3 times daily. The SM-only participants did not receive any tailored FB based on SM data. The primary outcome was percent weight change from baseline to 12 months. Secondary outcomes included engagement with digital tools (eg, monthly percentage of FB messages opened and monthly percentage of days adherent to the calorie goal). Results: Participants (N=502) were on average 45.0 (SD 14.4) years old with a mean BMI of 33.7 (SD 4.0) kg/m2. The sample was 79.5% female (n=399/502) and 82.5% White (n=414/502). At 12 months, retention was 78.5% (n=394/502) and similar by group (SM+FB: 202/251, 80.5%; SM: 192/251, 76.5%; P=.28). There was significant percent weight loss from baseline in both groups (SM+FB: –2.12%, 95% CI –3.04% to –1.21%, P<.001; SM: –2.39%, 95% CI –3.32% to –1.47%; P<.001), but no difference between the groups (–0.27%; 95% CI –1.57% to 1.03%; t =–0.41; P=.68). Similarly, 26.3% (66/251) of the SM+FB group and 29.1% (73/251) of the SM group achieved ≥5% weight loss (chi-square value=0.49; P=.49). A 1% increase in FB messages opened was associated with a 0.10 greater percent weight loss at 12 months (b=–0.10; 95% CI –0.13 to –0.07; t =–5.90; P<.001). A 1% increase in FB messages opened was associated with 0.12 greater percentage of days adherent to the calorie goal per month (b=0.12; 95% CI 0.07-0.17; F=22.19; P<.001). Conclusions: There were no significant between-group differences in weight loss; however, the findings suggested that the use of commercially available digital SM tools with or without FB resulted in a clinically significant weight loss in over 25% of participants. Future studies need to test additional strategies that will promote greater engagement with digital tools. Trial Registration: Clinicaltrials.gov NCT03367936; https://clinicaltrials.gov/ct2/show/NCT03367936 %M 35787516 %R 10.2196/38243 %U https://www.jmir.org/2022/7/e38243 %U https://doi.org/10.2196/38243 %U http://www.ncbi.nlm.nih.gov/pubmed/35787516 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 7 %P e35884 %T StudyU: A Platform for Designing and Conducting Innovative Digital N-of-1 Trials %A Konigorski,Stefan %A Wernicke,Sarah %A Slosarek,Tamara %A Zenner,Alexander M %A Strelow,Nils %A Ruether,Darius F %A Henschel,Florian %A Manaswini,Manisha %A Pottbäcker,Fabian %A Edelman,Jonathan A %A Owoyele,Babajide %A Danieletto,Matteo %A Golden,Eddye %A Zweig,Micol %A Nadkarni,Girish N %A Böttinger,Erwin %+ Digital Health Center, Hasso Plattner Institute for Digital Engineering, University of Potsdam, Prof.-Dr.-Helmert-Straße 2-3, Potsdam, 14482, Germany, 49 331 5509 4873, stefan.konigorski@hpi.de %K digital interventions %K N-of-1 trial %K SCED %K single-case experimental design %K web application %K mobile application %K app %K digital health %D 2022 %7 5.7.2022 %9 Viewpoint %J J Med Internet Res %G English %X N-of-1 trials are the gold standard study design to evaluate individual treatment effects and derive personalized treatment strategies. Digital tools have the potential to initiate a new era of N-of-1 trials in terms of scale and scope, but fully functional platforms are not yet available. Here, we present the open source StudyU platform, which includes the StudyU Designer and StudyU app. With the StudyU Designer, scientists are given a collaborative web application to digitally specify, publish, and conduct N-of-1 trials. The StudyU app is a smartphone app with innovative user-centric elements for participants to partake in trials published through the StudyU Designer to assess the effects of different interventions on their health. Thereby, the StudyU platform allows clinicians and researchers worldwide to easily design and conduct digital N-of-1 trials in a safe manner. We envision that StudyU can change the landscape of personalized treatments both for patients and healthy individuals, democratize and personalize evidence generation for self-optimization and medicine, and can be integrated in clinical practice. %M 35787512 %R 10.2196/35884 %U https://www.jmir.org/2022/7/e35884 %U https://doi.org/10.2196/35884 %U http://www.ncbi.nlm.nih.gov/pubmed/35787512 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 8 %N 3 %P e37212 %T Characteristics of Users of the Cook for Your Life Website, an Online Nutrition Resource for Persons Affected by Cancer: Descriptive Study %A Rillamas-Sun,Eileen %A Schattenkerk,Liza %A Cobos,Sofia %A Ueland,Katherine %A Gaffney,Ann Ogden %A Greenlee,Heather %+ Fred Hutchinson Cancer Center, Public Health Sciences, 1100 Fairview Ave N., M4-B402, Seattle, WA, 98109, United States, 1 206 667 4502, hgreenlee@fredhutch.org %K oncology nutrition %K eHealth %K website use %K bilingual %D 2022 %7 5.7.2022 %9 Original Paper %J JMIR Cancer %G English %X Background: Accessible nutrition resources tailored to patients with cancer, caregivers of cancer survivors, and people interested in cancer prevention are limited. Cook for Your Life is a bilingual (ie, English and Spanish) website providing science-based, nutrition information for people affected by cancer. Objective: The aim of this study was to describe the characteristics of Cook for Your Life website users. Methods: In December 2020, Cook for Your Life website visitors at least 18 years old were invited to participate in an online English-language survey. A Spanish version was offered in April 2021. Demographic, health, and cooking characteristics were collected. Persons with a cancer history were asked about treatment and side effects. Data were analyzed through December 2021 on those completing over half of the survey. Three groups were compared: people with a history of cancer diagnosis, caregivers of cancer survivors, and the general public (ie, people without a cancer history). Website use data were also compared. Results: Among English-language respondents, 3346 initiated the survey and 2665 (79.65%) completed over half of the questions. Of these, 54.82% (n=1461) had a cancer diagnosis, 8.26% (n=220) were caregivers, and 36.92% (n=984) were from the general public. English-language respondents were US residents (n=2054, 77.07%), with some from Europe (n=285, 10.69%) and Canada (n=170, 6.38%). Cancer survivors were most likely 55 years of age or older, female, non-Hispanic White, with incomes over US $100,000, and college educated. Caregivers and the general public were younger and more racially and geographically diverse. The most common cancer malignancies among English-language cancer survivors were breast (629/1394, 45.12%) and gastrointestinal (209/1394, 14.99%). For Spanish-language respondents, 942 initiated the survey; of these, 681 (72.3%) were analyzed. Of the 681 analyzed, 13.5% (n=92) were cancer survivors, 6.8% (n=46) were caregivers, and 79.7% (n=543) were from the general public. Spanish-language respondents were also more likely to be female and highly educated, but were younger, were from South or Latin America, and had incomes less than US $30,000. Among Spanish-language cancer survivors, breast cancer (27/81, 33%) and gastrointestinal cancer (15/81, 19%) were the most common diagnoses. Website use data on over 2.2 million users from December 2020 to December 2021 showed that 52.29% of traffic was in English and 43.44% was in Spanish. Compared to survey respondents, a higher proportion of website users were male, younger, and from South or Central America and Europe. Conclusions: Cook for Your Life website users were demographically, socioeconomically, and geographically diverse, especially English-language respondents without a cancer history and all Spanish-language respondents. Improvements on website user diversity and reach for all patients with cancer and research on effective strategies for using this digital platform to support cancer prevention, treatment, and survivorship will continue. Trial Registration: ClinicalTrials.gov NCT04200482; https://www.clinicaltrials.gov/ct2/show/NCT04200482 %M 35788100 %R 10.2196/37212 %U https://cancer.jmir.org/2022/3/e37212 %U https://doi.org/10.2196/37212 %U http://www.ncbi.nlm.nih.gov/pubmed/35788100 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 5 %N 3 %P e36770 %T Dose-Response Relationship of a Blended In-Person and Online Family-Based Childhood Obesity Management Program: Secondary Analysis of a Behavior Intervention %A Liu,Sam %A Smith,Nicholas %A Nuss,Kayla %A Perdew,Megan %A Adiputranto,Dimas %A Naylor,Patti-Jean %+ School of Exercise Science, Physical and Health Education, University of Victoria, PO Box 1700 STN CSC, Victoria, BC, V8W 2Y2, Canada, 1 2507218392, samliu@uvic.ca %K engagement %K dose response %K childhood obesity %K web-based intervention %K child %K obesity %K weight %K web based %K intervention %K family %K families %K lifestyle %K parent %K parental support %K healthy eating %K family support %K physical activity %K diet %K exercise %K fitness %K online portal %D 2022 %7 5.7.2022 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: The Early Intervention Program (EIP) was a 10-week, blended, in-person and online lifestyle intervention for families with children who were off the healthy weight trajectory. The engagement pattern and the dose response of EIP have not been examined. Objective: The aims of this paper are to examine families’ engagement patterns with the EIP and to evaluate the dose-response relationship between EIP engagement patterns and physical activity and healthy eating–related outcomes at 10 weeks. Methods: Families with children (8-12 years old) who are off the healthy weight trajectory (child BMI ≥85th percentile for age and sex) were recruited. Pre- and postintervention questionnaires assessed child lifestyle behaviors, parental support behaviors, family lifestyle habits, as well as parental physical activity and healthy-eating identity. Hierarchical cluster analysis of both in-person and online components was used to classify engagement patterns. Regression analysis assessed differences in outcomes by engagement groups. Results: Two distinct clusters of engagement groups were identified (N=66), which were in-person (IP; n=40, 61%) and in-person + online (IP+; n=26, 39%) engagement. Relative to the IP group at week 10, IP+ showed a greater child moderate-to-vigorous physical activity level (1.53, SD 0.56; P=.008), child physical activity confidence (1.04, SD 0.37; P=.007), parental support for child physical activity (5.54, SD 2.57; P=.04) and healthy eating (2.43, SD 1.16; P=.04), family habits for physical activity (3.02, SD 1.50; P=.049) and healthy eating (3.95, SD 1.84; P=.04), and parental identity for physical activity (2.82, SD 1.19; P=.02). Conclusions: The online EIP portal complemented the in-person sessions. Additional engagement with the portal was associated with greater improvements in child physical activity and parental support behaviors, habits, and identity for physical activity. %M 35787514 %R 10.2196/36770 %U https://pediatrics.jmir.org/2022/3/e36770 %U https://doi.org/10.2196/36770 %U http://www.ncbi.nlm.nih.gov/pubmed/35787514 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 7 %P e38005 %T Improvements in Depression Outcomes Following a Digital Cognitive Behavioral Therapy Intervention in a Polychronic Population: Retrospective Study %A Venkatesan,Aarathi %A Forster,Benjamin %A Rao,Prasanna %A Miller,Melissa %A Scahill,Michael %+ Vida Health, 100 Montgomery St, Ste 750, San Francisco, CA, 94104, United States, 1 14159891017, aarathi.venkatesan@vida.com %K depression %K anxiety %K CBT %K digital mental health intervention %K cognitive behavioral therapy %K digital health %K obesity %K diabetes %K mental health %D 2022 %7 5.7.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital mental health interventions have shown promise in reducing barriers to effective care for depression. Depression and related mental disorders are known to be highly comorbid with common chronic physical conditions, such as obesity and type 2 diabetes. While some research has explored the interaction dynamics of treating populations living with both mental and physical disorders, very little is known about such dynamics in digital care. Objective: We aimed to examine the effectiveness of a 12-week, therapist-supported, app-based cognitive behavioral therapy program in improving symptoms of depression and anxiety. The studied population included adults with a heavy burden of chronic physical disease, including obesity and type 2 diabetes. Methods: A total of 1512 participants with at least moderate depression were enrolled. The treatment cohort consisted of 831 (54.96%) participants who completed a follow-up assessment. The program included structured lessons and tools (ie, exercises and practices) and offered one-on-one weekly video counseling sessions with a licensed therapist for 12 weeks and monthly sessions thereafter. The clinically validated 8-item Patient Health Questionnaire (PHQ-8) and the 7-item Generalized Anxiety Disorder scale (GAD-7) were used to assess depression and anxiety, respectively. Linear mixed-effects modeling was employed to examine changes in depression and anxiety over time. Given correlation among various measures of program usage, a composite variable for depth of usage was used to analyze the correlation between usage and changes in depressive symptoms. Body weight changes from baseline were assessed primarily with digitally connected scales. Results: Out of 831 participants in the treatment cohort, 74.5% (n=619) showed a clinically significant reduction in depressive symptom severity after 12 weeks, where follow-up PHQ-8 scores had shifted downward by at least one diagnostic category. In total, 67.5% (n=561) of the participants showed a reliable improvement in PHQ-8 scores as measured by the reliable change index. There was an average reduction of 5.9 (SD 5.2) points (P<.001) between baseline and follow-up. Greater program usage was correlated with greater likelihood of reliable improvement in depressive symptoms (odds ratio 1.3, 95% CI 1.1-1.5; P=.002). An exploratory analysis of body weight changes with a multilevel, mixed-effect model suggested that reliable improvement in depressive symptoms at follow-up was associated with significantly greater weight loss at 9 months (β=–1.11, P=.002). Conclusions: The results provide further support that digital interventions can support clinically meaningful improvements in depression. Some form of synergy in treatment of comorbid depression and obesity or diabetes could be studied in future research. The study was limited by postintervention participant attrition as well as the retrospective observational study design. %M 35788442 %R 10.2196/38005 %U https://formative.jmir.org/2022/7/e38005 %U https://doi.org/10.2196/38005 %U http://www.ncbi.nlm.nih.gov/pubmed/35788442 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 3 %P e34925 %T The Influencing Contexts and Potential Mechanisms Behind the Use of Web-Based Self-management Support Interventions: Realistic Evaluation %A Engelen,Marscha %A van Gaal,Betsie %A Vermeulen,Hester %A Zuidema,Rixt %A Bredie,Sebastian %A van Dulmen,Sandra %+ IQ Healthcare, Radboud Institute for Health Sciences, Radboud university medical center, P O Box 9101, Nijmegen, 6500 HB, Netherlands, 31 630261845, marscha.engelen@radboudumc.nl %K self-management %K telemedicine %K chronic disease %K cardiovascular diseases %K rheumatoid arthritis %K patient dropouts %K realistic evaluation %K program use %D 2022 %7 1.7.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Self-management can increase self-efficacy and quality of life and improve disease outcomes. Effective self-management may also help reduce the pressure on health care systems. However, patients need support in dealing with their disease and in developing skills to manage the consequences and changes associated with their condition. Web-based self-management support programs have helped patients with cardiovascular disease (CVD) and rheumatoid arthritis (RA), but program use has been low. Objective: This study aimed to identify the patient, disease, and program characteristics that determine whether patients use web-based self-management support programs or not. Methods: A realistic evaluation methodology was used to provide a comprehensive overview of context (patient and disease characteristics), mechanism (program characteristics), and outcome (program use). Secondary data of adult patients with CVD (n=101) and those with RA (n=77) were included in the study. The relationship between context (sex, age, education, employment status, living situation, self-management [measured using Patient Activation Measure-13], quality of life [measured using RAND 36-item health survey], interaction efficacy [measured using the 5-item perceived efficacy in patient-physician interactions], diagnosis, physical comorbidity, and time since diagnosis) and outcome (program use) was analyzed using logistic regression analyses. The relationship between mechanism (program design, implementation strategies, and behavior change techniques [BCTs]) and outcome was analyzed through a qualitative interview study. Results: This study included 68 nonusers and 111 users of web-based self-management support programs, of which 56.4% (101/179) were diagnosed with CVD and 43.6% (78/179) with RA. Younger age and a lower level of education were associated with program use. An interaction effect was found between program use and diagnosis and 4 quality of life subscales (social functioning, physical role limitations, vitality, and bodily pain). Patients with CVD with higher self-management and quality of life scores were less likely to use the program, whereas patients with RA with higher self-management and quality of life scores were more likely to use the program. Interviews with 10 nonusers, 10 low users, and 18 high users were analyzed to provide insight into the relationship between mechanisms and outcome. Program use was encouraged by an easy-to-use, clear, and transparent design and by recommendations from professionals and email reminders. A total of 5 BCTs were identified as potential mechanisms to promote program use: tailored information, self-reporting behavior, delayed feedback, providing information on peer behavior, and modeling. Conclusions: This realistic evaluation showed that certain patient, disease, and program characteristics (age, education, diagnosis, program design, type of reminder, and BCTs) are associated with the use of web-based self-management support programs. These results represent the first step in improving the tailoring of web-based self-management support programs. Future research on the interaction between patient and program characteristics should be conducted to improve the tailoring of participants to program components. %M 35776437 %R 10.2196/34925 %U https://humanfactors.jmir.org/2022/3/e34925 %U https://doi.org/10.2196/34925 %U http://www.ncbi.nlm.nih.gov/pubmed/35776437 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 6 %P e36091 %T Development of a WeChat-based Mobile Messaging Smoking Cessation Intervention for Chinese Immigrant Smokers: Qualitative Interview Study %A Jiang,Nan %A Rogers,Erin S %A Cupertino,Paula %A Zhao,Xiaoquan %A Cartujano-Barrera,Francisco %A Lyu,Joanne Chen %A Hu,Lu %A Sherman,Scott E %+ Department of Population Health, Grossman School of Medicine, New York University, 180 Madison Ave, Rm #17-54, New York, NY, 10016, United States, 1 646 501 3553, Nan.Jiang@nyulangone.org %K smoking cessation %K text messaging %K mobile health %K Chinese American %D 2022 %7 30.6.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Smoking remains a major public health issue among Chinese immigrants. Smoking cessation programs that focus on this population are scarce and have a limited population-level impact due to their low reach. Mobile messaging interventions have the potential to reach large audiences and expand smokers’ access to smoking cessation treatment. Objective: This study describes the development of a culturally and linguistically appropriate mobile messaging smoking cessation intervention for Chinese immigrant smokers delivered via WeChat, the most frequently used social media platform among Chinese people globally. Methods: This study had 2 phases. In phase 1, we developed a mobile message library based on social cognitive theory and the US Clinical Practice Guidelines for Treating Tobacco Use and Dependence. We culturally adapted messages from 2 social cognitive theory-based text messaging smoking cessation programs (SmokefreeTXT and Decídetexto). We also developed new messages targeting smokers who were not ready to quit smoking and novel content addressing Chinese immigrant smokers’ barriers to quitting and common misconceptions related to willpower and nicotine replacement therapy. In phase 2, we conducted in-depth interviews with 20 Chinese immigrant smokers (including 7 women) in New York City between July and August 2021. The interviews explored the participants’ smoking and quitting experiences followed by assessment of the text messages. Participants reviewed 17 text messages (6 educational messages, 3 self-efficacy messages, and 8 skill messages) via WeChat and rated to what extent the messages enhanced their motivation to quit, promoted confidence in quitting, and increased awareness about quitting strategies. The interviews sought feedback on poorly rated messages, explored participant preferences for content, length, and format, discussed their concerns with WeChat cessation intervention, and solicited recommendations for frequency and timing of messages. Results: Overall, participants reported that the messages enhanced their motivation to quit, offered encouragement, and made them more informed about how to quit. Participants particularly liked the messages about the harms of smoking and strategies for quitting. They reported barriers to applying some of the quitting strategies, including coping with stress and staying abstinent at work. Participants expressed strong interest in the WeChat mobile messaging cessation intervention and commented on its potential to expand their access to smoking cessation treatment. Conclusions: Mobile messages are well accepted by Chinese immigrant smokers. Research is needed to assess the feasibility, acceptability, and efficacy of WeChat mobile messaging smoking cessation interventions for promoting abstinence among Chinese immigrant smokers. %M 35771603 %R 10.2196/36091 %U https://formative.jmir.org/2022/6/e36091 %U https://doi.org/10.2196/36091 %U http://www.ncbi.nlm.nih.gov/pubmed/35771603 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 6 %P e33813 %T Therapeutic Alliance in Web-Based Treatment for Eating Disorders: Secondary Analysis of a Randomized Controlled Trial %A Stoeten,Claudia %A de Haan,Hein Arnoud %A Postel,Marloes Gerda %A Brusse-Keizer,Marjolein %A ter Huurne,Elke Daniëlle %+ Tactus Addiction Care, Keulenstraat 3, 7418 ET, Deventer, 7400 AD, Netherlands, 31 883822887, h.dehaan@tactus.nl %K therapeutic alliance %K TA %K treatment completion %K cognitive behavioral therapy %K CBT %K web-CBT %K eating disorders %D 2022 %7 30.6.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: In face-to-face therapy for eating disorders, therapeutic alliance (TA) is an important predictor of symptom reduction and treatment completion. To date, however, little is known about TA during web-based cognitive behavioral therapy (web-CBT) and its association with symptom reduction, treatment completion, and the perspectives of patients versus therapists. Objective: This study aimed to investigate TA ratings measured at interim and after treatment, separately for patients and therapists; the degree of agreement between therapists and patients (treatment completers and noncompleters) for TA ratings; and associations between patient and therapist TA ratings and both eating disorder pathology and treatment completion. Methods: A secondary analysis was performed on randomized controlled trial data of a web-CBT intervention for eating disorders. Participants were 170 females with bulimia nervosa (n=33), binge eating disorder (n=68), or eating disorder not otherwise specified (n=69); the mean age was 39.6 (SD 11.5) years. TA was operationalized using the Helping Alliance Questionnaire (HAQ). Paired t tests were conducted to assess the change in TA from interim to after treatment. Intraclass correlations were calculated to determine cross-informant agreement with regard to HAQ scores between patients and therapists. A total of 2 stepwise regressive procedures (at interim and after treatment) were used to examine which HAQ scores predicted eating disorder pathology and therapy completion. Results: For treatment completers (128/170, 75.3%), the HAQ-total scores and HAQ-Helpfulness scores for both patients and therapists improved significantly from interim to post treatment. For noncompleters (42/170, 24.7%), all HAQ scores decreased significantly. For all HAQ scales, the agreement between patients and therapists was poor. However, the agreement was slightly better after treatment than at interim. Higher patient scores on the helpfulness subscale of the HAQ at interim and after treatment were associated with less eating disorder psychopathology. A positive association was found between the HAQ-total patient scores at interim and treatment completion. Finally, posttreatment HAQ-total patient scores and posttreatment HAQ-Helpfulness scores of therapists were positively associated with treatment completion. Conclusions: Our study showed that TA in web-CBT is predictive of eating disorder pathology and treatment completion. Of particular importance is patients’ confidence in their abilities as measured with the HAQ-Helpfulness subscale when predicting posttreatment eating disorder pathology and treatment completion. %M 35771608 %R 10.2196/33813 %U https://formative.jmir.org/2022/6/e33813 %U https://doi.org/10.2196/33813 %U http://www.ncbi.nlm.nih.gov/pubmed/35771608 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 6 %N 1 %P e29035 %T Movement as Medicine for Cardiovascular Disease Prevention: Pilot Feasibility Study of a Physical Activity Promotion Intervention for At-Risk Patients in Primary Care %A Knittle,Keegan %A Charman,Sarah J %A O'Connell,Sophie %A Avery,Leah %A Catt,Michael %A Sniehotta,Falko F %A Trenell,Michael I %+ Population Health Sciences Institute, Newcastle University, Baddiley-Clark Building, Newcastle upon Tyne, NE1 7RU, United Kingdom, 44 191 208 2258, michael.trenell@ncl.ac.uk %K primary care %K physical activity %K cardiovascular disease %K prevention %K internet-based intervention %K motivational interviewing %K self-regulation %D 2022 %7 29.6.2022 %9 Original Paper %J JMIR Cardio %G English %X Background: Physical activity (PA) can reduce cardiovascular disease (CVD) risk factors, and although primary care settings offer a large reach to promote PA and reduce CVD risk, primary health care professionals may lack self-efficacy and tools to effectively promote PA in practice. Movement as Medicine for CVD Prevention is a suite of 2 theory-based, web-based behavioral interventions—one for health care professionals and one for patients—which may offer a pathway for promoting PA and reducing CVD risk in primary care. Objective: This study aims to examine the feasibility and possible effects of Movement as Medicine for CVD Prevention. Methods: This nonrandomized pilot study recruited participants from primary care organizations in the Northeast of England. Enrolled health care professionals followed a theory-based, web-based course on PA counseling and motivational interviewing techniques. After the course, health care professionals delivered behavior change consultations based on motivational interviewing to inactive individuals with >20% risk of developing CVD within 10 years. Patients were then given access to a website based on self-determination and self-regulation theories, which targeted increased levels of PA. Outcomes were assessed at baseline and after 3 months, and patient data were analyzed on an intention-to-treat basis in a multiple imputation data set. Results: Recruitment rates of primary care organizations fell below expectations. A total of 11 health care professionals from 3 enrolled primary care organizations completed the web-based course and reported increases in important theoretical determinants of PA promotion in practice (eg, self-efficacy, Cohen d=1.24, 95% CI 0.67-1.80; and planning, Cohen d=0.85, 95% CI −0.01 to 1.69). A total of 83 patients were enrolled in the study, and 58 (70%) completed both the baseline and 3-month assessments. Compared with baseline, patients had higher levels of objective (Cohen d=0.77, 95% CI 0.13-1.41) but not subjective (Cohen d=0.40, 95% CI −0.03 to 0.83) moderate to vigorous PA at 3 months. Patients also reported higher levels of the PA determinants of intention, self-efficacy, intrinsic motivation, and action planning and action control at 3 months (effect sizes ranged from Cohen d=0.39 to 0.60). Conclusions: The Movement as Medicine for CVD Prevention intervention seems to have the potential to improve patient PA behaviors and important determinants of health care professionals’ PA promotion practices. However, the recruitment rates of primary care organizations in this study were low and would need to be increased to examine the efficacy of the program. This study offers several insights into improving the feasibility of this primary care PA promotion pathway. Trial Registration: ISRCTN Registry ISRCTN14582348; http://www.isrctn.com/ISRCTN14582348 %M 35767316 %R 10.2196/29035 %U https://cardio.jmir.org/2022/1/e29035 %U https://doi.org/10.2196/29035 %U http://www.ncbi.nlm.nih.gov/pubmed/35767316 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 6 %P e36809 %T Long-term Effects of a Social Media–Based Intervention (Run4Love) on Depressive Symptoms of People Living With HIV: 3-Year Follow-up of a Randomized Controlled Trial %A Guo,Yan %A Li,Yingqi %A Yu,Chuanchuan %A Xu,He %A Hong,Y Alicia %A Wang,Xiaolan %A Zhang,Nanxiang %A Zeng,Yu %A Monroe-Wise,Aliza %A Li,Linghua %A Liu,Cong %A Cai,Weiping %A Lin,Aihua %+ Department of Medical Statistics, School of Public Health, Sun Yat-sen University, #74 Zhongshan 2nd Road, Guangzhou, 510080, China, 86 020 87334202, Yan.Guo1@umassmed.edu %K HIV %K depressive symptoms %K mobile health %K mHealth %K social media–based %K long-term intervention effect %D 2022 %7 28.6.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Emerging studies have shown the effectiveness of mobile health (mHealth) interventions in reducing depressive symptoms among people living with HIV. Most of these studies included only short-term follow-up, with limited data on long-term effects. Objective: The purpose of this study is to assess the long-term effects of a randomized controlled trial called Run4Love on depressive symptoms among people living with HIV at 1-year and 3-year follow-ups. Methods: A total of 300 people living with HIV with depressive symptoms were recruited and randomized to an intervention or a control group in Guangzhou, China, from September 2017 to January 2018. The intervention group received a 3-month Run4Love program, including adapted evidence-based cognitive behavioral stress management courses and exercise promotion via WeChat (Tencent), a popular social media app. The control group received usual care and a brochure on nutrition. The primary outcome was reduction in depressive symptoms, measured using the Center for Epidemiological Studies–Depression (CES-D) scale. Data used in this study were collected at baseline and at the 1-year and 3-year follow-ups. Generalized estimating equations were used to examine the group differences at 1-year and 3-year follow-ups. Results: Approximately half of the participants completed the assessment at 1-year (149/300, 49.7%) and 3-year (177/300, 59%) follow-ups. At 1-year follow-up, participants in the intervention group reported significant reduction in depressive symptoms compared with the control group (CES-D: from 23.9 to 18.1 in the intervention group vs from 24.3 to 23.3 in the control group; mean −4.79, SD 13.56; 95% CI −7.78 to −1.81; P=.002). At 3-year follow-up, between-group difference in CES-D remained statistically significant (from 23.9 to 20.5 in the intervention group vs from 24.3 to 24.4 in the control group; mean −3.63, SD 13.35; 95% CI −6.71 to −0.54; P=.02). No adverse events were reported during the 3-year follow-up period. Conclusions: The mHealth intervention, Run4Love, significantly reduced depressive symptoms among people living with HIV, and the intervention effects were sustained at 1-year and 3-year follow-ups. Further research is needed to explore the mechanisms of the long-term effects of mHealth interventions such as Run4Love and to implement these effective interventions among people living with HIV. Trial Registration: Chinese Clinical Trial Registry ChiCTR-IPR-17012606; https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR-IPR-17012606 International Registered Report Identifier (IRRID): RR2-10.2196/10274 %M 35763324 %R 10.2196/36809 %U https://www.jmir.org/2022/6/e36809 %U https://doi.org/10.2196/36809 %U http://www.ncbi.nlm.nih.gov/pubmed/35763324 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 6 %P e31921 %T What are Digital Public Health Interventions? First Steps Toward a Definition and an Intervention Classification Framework %A Wienert,Julian %A Jahnel,Tina %A Maaß,Laura %+ Health Psychology, Social Sciences, IU International University for Applied Sciences, Kaiserplatz 1, Bad Reichenhall, 83435, Germany, 49 1725858645, julian.wienert@iu.org %K digital health %K digital Public Health %K digital public health interventions %K digital health technologies %K mHealth %K eHealth %K participatory approach %K framework %K mobile phone %D 2022 %7 28.6.2022 %9 Viewpoint %J J Med Internet Res %G English %X Digital public health is an emerging field in population-based research and practice. The fast development of digital technologies provides a fundamentally new understanding of improving public health by using digitalization, especially in prevention and health promotion. The first step toward a better understanding of digital public health is to conceptualize the subject of the assessment by defining what digital public health interventions are. This is important, as one cannot evaluate tools if one does not know what precisely an intervention in this field can be. Therefore, this study aims to provide the first definition of digital public health interventions. We will merge leading models for public health functions by the World Health Organization, a framework for digital health technologies by the National Institute for Health and Care Excellence, and a user-centered approach to intervention development. Together, they provide an overview of the functions and areas of use for digital public health interventions. Nevertheless, one must keep in mind that public health functions can differ among different health care systems, limiting our new framework’s universal validity. We conclude that a digital public health intervention should address essential public health functions through digital means. Furthermore, it should include members of the target group in the development process to improve social acceptance and achieve a population health impact. %M 35763320 %R 10.2196/31921 %U https://www.jmir.org/2022/6/e31921 %U https://doi.org/10.2196/31921 %U http://www.ncbi.nlm.nih.gov/pubmed/35763320 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 2 %P e34278 %T User Perceptions of eHealth and mHealth Services Promoting Physical Activity and Healthy Diets: Systematic Review %A Bergevi,Julia %A Andermo,Susanne %A Woldamanuel,Yohannes %A Johansson,Unn-Britt %A Hagströmer,Maria %A Rossen,Jenny %+ Department of Health Promoting Science, Sophiahemmet University, Lindstedsvägen 8, Stockholm, 11486, Sweden, 46 701718634, jenny.rossen@shh.se %K acceptability %K behavior change %K engagement %K health technology %K noncommunicable diseases %K usability %K user feedback %K qualitative studies %K physical activity %K healthy diet %D 2022 %7 28.6.2022 %9 Review %J JMIR Hum Factors %G English %X Background: Physical activity and a diet that follows general recommendations can help to prevent noncommunicable diseases. However, most adults do not meet current recommended guidelines, and support for behavior change needs to be strengthened. There is growing evidence that shows the benefits of eHealth and mobile health (mHealth) services in promoting healthy habits; however, their long-term effectiveness is uncertain because of nonadherence. Objective: We aimed to explore users’ perceptions of acceptability, engagement, and usability of eHealth and mHealth services that promote physical activity, healthy diets, or both in the primary or secondary prevention of noncommunicable diseases. Methods: We conducted a systematic review with a narrative synthesis. We performed the literature search in PubMed, PsycINFO, and CINAHL electronic databases in February 2021 and July 2021. The search was limited to papers published in English between 2016 and 2021. Papers on qualitative and mixed method studies that encompassed eHealth and mHealth services for adults with a focus on physical activity, healthy diet, or both in the primary or secondary prevention of noncommunicable diseases were included. Three authors screened the studies independently, and 2 of the authors separately performed thematic analysis of qualitative data. Results: With an initial finding of 6308 articles and the removal of 427 duplicates, 23 articles were deemed eligible for inclusion in the review. Based on users’ preferences, an overarching theme—eHealth and mHealth services provide value but need to be tailored to individual needs—and 5 subthemes—interactive and integrated; varying and multifunctional; easy, pedagogic, and attractive; individualized and customizable; and reliable—emerged. Conclusions: New evidence on the optimization of digital services that promote physical activity and healthy diets has been synthesized. The findings represent users’ perceptions of acceptability, engagement, and usability of eHealth and mHealth services and show that services should be personalized, dynamic, easily manageable, and reliable. These findings can help improve adherence to digital health-promoting services. %M 35763339 %R 10.2196/34278 %U https://humanfactors.jmir.org/2022/2/e34278 %U https://doi.org/10.2196/34278 %U http://www.ncbi.nlm.nih.gov/pubmed/35763339 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 6 %P e34863 %T Effectiveness of Recruitment Strategies of Latino Smokers: Secondary Analysis of a Mobile Health Smoking Cessation Randomized Clinical Trial %A Arana-Chicas,Evelyn %A Cartujano-Barrera,Francisco %A Rieth,Katherine K %A Richter,Kimber K %A Ellerbeck,Edward F %A Cox,Lisa Sanderson %A Graves,Kristi D %A Diaz,Francisco J %A Catley,Delwyn %A Cupertino,Ana Paula %+ Department of Surgery, University of Rochester School of Medicine & Dentistry, 265 Crittenden Blvd, Rochester, NY, 14642, United States, 1 585 287 4217, Evelyn_Arana@urmc.rochester.edu %K smoking cessation %K Latino health, Latino recruitment %K health disparities %K participant recruitment %D 2022 %7 27.6.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Latinos remain disproportionately underrepresented in clinical trials, comprising only 2%-3% of research participants. In order to address health disparities, it is critically important to increase enrollment of Latino smokers in smoking cessation trials. There is limited research examining effective recruitment strategies for this population. Objective: The purpose of this study was to compare the effectiveness of direct versus mass and high- versus low-effort recruitment strategies on recruitment and retention of Latino smokers to a randomized smoking cessation trial. We also examine how the type of recruitment might have influenced the characteristics of enrolled participants. Methods: Latino smokers were enrolled into Decídetexto from 4 states—New Jersey, Kansas, Missouri, and New York. Participants were recruited from August 2018 until March 2021. Mass recruitment strategies included English and Spanish advertisements to the Latino community via flyers, Facebook ads, newspapers, television, radio, church bulletins, and our Decídetexto website. Direct, high-effort strategies included referrals from clinics or community-based organizations with whom we partnered, in-person community outreach, and patient registry calls. Direct, low-effort strategies included texting or emailing pre-existing lists of patients who smoked. A team of trained bilingual (English and Spanish) recruiters from 9 different Spanish-speaking countries of origin conducted recruitment, assessed eligibility, and enrolled participants into the trial. Results: Of 1112 individuals who were screened, 895 (80.5%) met eligibility criteria, and 457 (457/895, 51.1%) enrolled in the trial. Within the pool of screened individuals, those recruited by low-effort recruitment strategies (both mass and direct) were significantly more likely to be eligible (odds ratio [OR] 1.67, 95% CI 1.01-2.76 and OR 1.70, 95% CI 0.98-2.96, respectively) and enrolled in the trial (OR 2.60, 95% CI 1.81-3.73 and OR 3.02, 95% CI 2.03-4.51, respectively) compared with those enrolled by direct, high-effort strategies. Among participants enrolled, the retention rates at 3 months and 6 months among participants recruited via low-effort strategies (both mass and direct) were similar to participants recruited via direct, high-effort methods. Compared with enrolled participants recruited via direct (high- and low-effort) strategies, participants recruited via mass strategies were less likely to have health insurance (44.0% vs 71.2% and 71.7%, respectively; P<.001), lived fewer years in the United States (22.4 years vs 32.4 years and 30.3 years, respectively; P<.001), more likely to be 1st generation (92.7% vs 76.5% and 77.5%, respectively; P=.007), more likely to primarily speak Spanish (89.3% vs 65.8% and 66.3%, respectively), and more likely to be at high risk for alcohol abuse (5.8 mean score vs 3.8 mean score and 3.9 mean score, respectively; P<.001). Conclusions: Although most participants were recruited via direct, high-effort strategies, direct low-effort recruitment strategies yielded a screening pool more likely to be eligible for the trial. Mass recruitment strategies were associated with fewer acculturated enrollees with lower access to health services—groups who might benefit a great deal from the intervention. Trial Registration: ClinicalTrials.gov identifier: NCT03586596; https://clinicaltrials.gov/ct2/show/NCT03586596 International Registered Report Identifier (IRRID): RR2-10.1016/j.cct.2020.106188 %M 35759320 %R 10.2196/34863 %U https://www.jmir.org/2022/6/e34863 %U https://doi.org/10.2196/34863 %U http://www.ncbi.nlm.nih.gov/pubmed/35759320 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 6 %P e37414 %T Remotely Delivered Behavioral Weight Loss Intervention Using an Ad Libitum Plant-Based Diet: Pilot Acceptability, Feasibility, and Preliminary Results %A Chwyl,Christina %A Wright,Nicholas %A M Turner-McGrievy,Gabrielle %A L Butryn,Meghan %A M Forman,Evan %+ Center for Weight, Eating, and Lifestyle Sciences, Drexel University, 3141 Chestnut Street, Philadelphia, PA, 19104, United States, 1 267 606 0414, cmc646@drexel.edu %K vegetarian diet %K vegan diet %K overweight %K eHealth %K behavioral intervention %D 2022 %7 23.6.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Many traditional lifestyle interventions use calorie prescriptions, but most individuals have difficulty sustaining calorie tracking and thus weight loss. In contrast, whole food plant-based diets (WFPBDs) have previously shown significant weight loss without this issue. However, most WFPBD interventions are face-to-face and time-intensive, and do not leverage gold standard behavioral strategies for health behavior change. Objective: This open pilot trial was the first to evaluate the feasibility of a fully featured, remotely delivered behavioral weight loss intervention using an ad libitum WFPBD. Methods: Over 12 weeks, participants (N=15) with overweight or obesity received a newly designed program that integrated behavioral weight loss and a WFPBD prescription via weekly web-based modules and brief phone coaching calls. Assessments were performed at baseline, midtreatment (6 weeks), and after treatment (12 weeks). Results: The intervention was rated as highly acceptable (mean 4.40 out of 5, SE 0.18), and attrition was low (6.7%). In all, intention-to-treat analyses revealed that 69% (10.4/15) of the participants lost 5% of their weight (mean –5.89, SE 0.68 kg). Predefined benchmarks for quality of life were met. Conclusions: A pilot digital behavioral weight loss intervention with a non–energy-restricted WFPBD was feasible, and the mean acceptability was high. Minimal contact time (80-150 minutes of study interventionist time per participant over 12 weeks) led to clinically relevant weight loss and dietary adherence for most participants (10.4/15, 69% and 11.8/15, 79%, respectively), and quality of life improvements (reliable change indices >1.53). We hope that this work will serve as a springboard for future larger scale randomized controlled studies evaluating the efficacy of such programs for weight loss, dietary change, and quality of life. Trial Registration: ClinicalTrials.gov NCT04892030; https://clinicaltrials.gov/ct2/show/NCT04892030 %M 35737443 %R 10.2196/37414 %U https://formative.jmir.org/2022/6/e37414 %U https://doi.org/10.2196/37414 %U http://www.ncbi.nlm.nih.gov/pubmed/35737443 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 6 %P e39026 %T Supporting People Who Have Lost a Close Person by Bereavement or Separation: Protocol of a Randomized Controlled Trial Comparing Two French-Language Internet-Based Interventions %A Debrot,Anik %A Kheyar,Maya %A Efinger,Liliane %A Berthoud,Laurent %A Pomini,Valentino %+ Cognitive and Affective Regulation Laboratory, Institute of Psychology, University of Lausanne, Géopolis, Lausanne, 1015, Switzerland, 41 216923239, anik.debrot@unil.ch %K internet-based interventions %K grief %K bereavement %K separation %K divorce %K identity %K digital health %K mental health %K psychotherapy %D 2022 %7 23.6.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Internet-based interventions (IBIs) are as efficient as face-to-face psychotherapy for a variety of mental health disorders, including complicated grief. Most evidence stems from guided IBIs. However, recent research indicates that the benefit of guidance is lower in more interactive IBIs. As such, providing guidance only to people requiring it (guidance on demand) appears a cost-effective solution. This is particularly important to develop given the recent rise in grief symptoms in the context of the COVID-19 pandemic. This paper presents the protocol of a randomized controlled trial comparing the efficacy and adherence rate of 2 IBIs for grief-related symptoms after the loss a close one following death or romantic separation, using a guidance on demand framework. LIVIA 2.0 was developed based on theoretical and empirical findings on grief processes and IBIs, and it will be compared to LIVIA 1 that has already demonstrated its efficacy. Objective: Our main hypotheses are that LIVIA 1 (control condition) and LIVIA 2.0 (experimental condition) increase participants’ well-being and decrease their distress at posttest and at follow-up, that LIVIA 2.0 is more efficient than LIVIA 1 for all outcomes, and that LIVIA 2.0 has less dropouts than LIVIA 1. Methods: Outcomes will be assessed at pretest, posttest (12 weeks later), and follow-up (24 weeks later). We will recruit 234 participants through a variety of means, including social media and contacts with the press. Primary outcomes are grief symptoms, depressive symptoms, and eudemonic well-being. Secondary outcomes are anxiety symptoms, grief coping strategies, aspects related to self-identity reorganization, and program satisfaction. LIVIA 2.0 participants will additionally undergo a weekly mood and grief symptom monitoring, allowing us to explore the short-term efficacy of the sessions. Results: The creation and development of the content of LIVIA 2.0 was completed during the first phase of the project. Participant recruitment will begin in May 2022 and will last until January 2023. Conclusions: This study will emphasize the relevance of the innovations included in LIVIA 2.0 regarding the efficacy and dropout rate of IBIs for grief symptoms and will allow investigations on how these changes impact the demand for guidance. In the current postpandemic times, developing and assessing IBIs targeting grief symptoms are particularly critical given the rise in grief-related symptoms. Trial Registration: clinicaltrials.gov NCT05219760; https://tinyurl.com/3dzztjts International Registered Report Identifier (IRRID): PRR1-10.2196/39026 %M 35737454 %R 10.2196/39026 %U https://www.researchprotocols.org/2022/6/e39026 %U https://doi.org/10.2196/39026 %U http://www.ncbi.nlm.nih.gov/pubmed/35737454 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 6 %P e35285 %T The Aim2Be mHealth Intervention for Children With Overweight or Obesity and Their Parents: Person-Centered Analyses to Uncover Digital Phenotypes %A De-Jongh González,Olivia %A Tugault-Lafleur,Claire N %A Buckler,E Jean %A Hamilton,Jill %A Ho,Josephine %A Buchholz,Annick %A Morrison,Katherine M %A Ball,Geoff DC %A Mâsse,Louise C %+ School of Population and Public Health, University of British Columbia, BC Children's Hospital Research Institute, 4480 Oak St., Vancouver, BC, V6H 3V4, Canada, 1 6048752000 ext 5563, lmasse@bcchr.ubc.ca %K mobile health %K mHealth %K childhood obesity %K digital phenotypes %K latent class analysis %D 2022 %7 22.6.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite the growing number of mobile health (mHealth) interventions targeting childhood obesity, few studies have characterized user typologies derived from individuals’ patterns of interactions with specific app features (digital phenotypes). Objective: This study aims to identify digital phenotypes among 214 parent-child dyads who used the Aim2Be mHealth app as part of a randomized controlled trial conducted between 2019 and 2020, and explores whether participants’ characteristics and health outcomes differed across phenotypes. Methods: Latent class analysis was used to identify distinct parent and child phenotypes based on their use of the app’s behavioral, gamified, and social features over 3 months. Multinomial logistic regression models were used to assess whether the phenotypes differed by demographic characteristics. Covariate-adjusted mixed-effect models evaluated changes in BMI z scores (zBMI), diet, physical activity, and screen time across phenotypes. Results: Among parents, 5 digital phenotypes were identified: socially engaged (35/214, 16.3%), independently engaged (18/214, 8.4%) (socially and independently engaged parents are those who used mainly the social or the behavioral features of the app, respectively), fully engaged (26/214, 12.1%), partially engaged (32/214, 15%), and unengaged (103/214, 48.1%) users. Married parents were more likely to be fully engaged than independently engaged (P=.02) or unengaged (P=.01) users. Socially engaged parents were older than fully engaged (P=.02) and unengaged (P=.01) parents. The latent class analysis revealed 4 phenotypes among children: fully engaged (32/214, 15%), partially engaged (61/214, 28.5%), dabblers (42/214, 19.6%), and unengaged (79/214, 36.9%) users. Fully engaged children were younger than dabblers (P=.04) and unengaged (P=.003) children. Dabblers lived in higher-income households than fully and partially engaged children (P=.03 and P=.047, respectively). Fully engaged children were more likely to have fully engaged (P<.001) and partially engaged (P<.001) parents than unengaged children. Compared with unengaged children, fully and partially engaged children had decreased total sugar (P=.006 and P=.004, respectively) and energy intake (P=.03 and P=.04, respectively) after 3 months of app use. Partially engaged children also had decreased sugary beverage intake compared with unengaged children (P=.03). Similarly, children with fully engaged parents had decreased zBMI, whereas children with unengaged parents had increased zBMI over time (P=.005). Finally, children with independently engaged parents had decreased caloric intake, whereas children with unengaged parents had increased caloric intake over time (P=.02). Conclusions: Full parent-child engagement is critical for the success of mHealth interventions. Further research is needed to understand program design elements that can affect participants’ engagement in supporting behavior change. Trial Registration: ClinicalTrials.gov NCT03651284; https://clinicaltrials.gov/ct2/show/NCT03651284 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-020-4080-2 %M 35731547 %R 10.2196/35285 %U https://www.jmir.org/2022/6/e35285 %U https://doi.org/10.2196/35285 %U http://www.ncbi.nlm.nih.gov/pubmed/35731547 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 6 %P e36521 %T Predictors of Disengagement and Symptom Improvement Among Adults With Depression Enrolled in Talkspace, a Technology-Mediated Psychotherapy Platform: Naturalistic Observational Study %A Darnell,Doyanne %A Pullmann,Michael D %A Hull,Thomas D %A Chen,Shiyu %A Areán,Patricia %+ Department of Psychiatry & Behavioral Sciences, University of Washington, 325 Ninth Avenue, Box 359911, Seattle, WA, 98104, United States, 1 206 744 9108, darnelld@uw.edu %K depression %K psychotherapy %K disengagement %K internet %K web-based %K technology-mediated psychotherapy %D 2022 %7 22.6.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Depression is a common psychiatric condition with an estimated lifetime prevalence for major depression of 16.6% in the US adult population and is effectively treated through psychotherapy. The widespread availability of the internet and personal devices such as smartphones are changing the landscape of delivery of psychotherapy; however, little is known about whether and for whom this type of therapy is beneficial, and whether having synchronous video-based sessions provides additional benefits to clients above and beyond messaging-based therapy. Objective: This study examined the outcomes associated with the use of a digital platform (Talkspace) for technology-mediated psychotherapy. We examined the duration of client engagement in therapy and client depression score trajectories over 16 weeks. We explored the association of client characteristics, therapist characteristics, and service plan type with time-to-disengagement and trajectories of change in depression scores. Methods: This naturalistic observational study assessed data collected routinely by the platform between January 2016 and January 2018 and examined psychotherapy outcomes among a large representative sample of adult clients with clinically significant depression. Treatment disengagement was defined as a lack of client-initiated communication for more than 4 weeks. Clients completed the Patient Health Questionnaire-8 item (PHQ-8) at intake and every 3 weeks via an in-app survey. Cox regression analysis was used to examine the time until and predictors of disengagement. Changes in depression scores and predictors of change over time were examined using mixed-effects regression. Results: The study included 5890 clients and 1271 therapists. Client scores on the PHQ-8 declined over time, with the average client improving from a score of 15 to below the clinical cutoff of 10 by week 6. At the same time point, 37% of clients had disengaged from the therapy. When combined into a final Cox regression model, those who were more likely to disengage were clients aged 18 to 25 years versus those aged ≥50 years (odds ratio [OR] 0.82, 95% CI 0.74-0.9; P<.001), had higher education (OR 1.14, 95% CI 1.06-1.22; P<.001), had been in therapy before (OR 1.09, 95% CI 1.02-1.17; P=.01), and were living with a partner but unmarried versus single (OR 1.14, 95% CI 1.02-1.27; P=.02). Having a therapist with >10 years of experience was related to lower odds of disengagement (OR 0.87, 95% CI 0.8-0.94; P=.01). When combined into a final regression model predicting improvement in depression scores over time, clients showing more improvement were those with an associate’s degree or higher (linear estimate=−0.07, P=.002) and higher intake PHQ-8 scores (estimate=3.73, P<.001). There were no differences based on the plan type. Conclusions: Our findings add to the growing literature showing the benefits of technology-mediated psychotherapy over a relatively brief period (16 weeks). %M 35731563 %R 10.2196/36521 %U https://formative.jmir.org/2022/6/e36521 %U https://doi.org/10.2196/36521 %U http://www.ncbi.nlm.nih.gov/pubmed/35731563 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 6 %P e35496 %T Conceptual Invariance, Trajectories, and Outcome Associations of Working Alliance in Unguided and Guided Internet-Based Psychological Interventions: Secondary Analysis of a Randomized Controlled Trial %A Luo,Xiaochen %A Bugatti,Matteo %A Molina,Lucero %A Tilley,Jacqueline L %A Mahaffey,Brittain %A Gonzalez,Adam %+ Department of Counseling Psychology, Santa Clara University, 500 El Camino Real, Santa Clara, CA, 95050, United States, 1 408 554 4000, xluo@scu.edu %K working alliance %K internet-based psychological interventions %K video support %K text support %K trajectory %K MyCompass %D 2022 %7 21.6.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: The role of working alliance remains unclear for many forms of internet-based interventions (IBIs), a set of effective psychotherapy alternatives that do not require synchronous interactions between patients and therapists. Objective: This study examined the conceptual invariance, trajectories, and outcome associations of working alliance across an unguided IBI and guided IBIs that incorporated clinician support through asynchronous text messaging or video messaging. Methods: Adults with high education attainment (n=145) with subclinical levels of anxiety, stress, or depressive symptoms were randomized to 1 of 3 treatment conditions for 7 weeks. All participants received treatments from MyCompass, an unguided IBI using cognitive behavior therapy. Participants in condition 2 and 3 received supplemental, asynchronous clinician support through text and video, respectively. Working alliance with the IBIs was measured weekly using select items from the 12-item version of the Agnew Relationship Measure. Symptom and functional outcomes were assessed at baseline, at the end of treatment, and 1-month follow-up. Results: Working alliance with the IBIs was conceptually invariant across the 3 conditions. Working alliance followed a quadratic pattern of change over time for all conditions and declined significantly only in the text-support condition. After controlling for baseline symptoms, higher baseline levels of working alliance predicted less depression and less functional impairment at follow-up, whereas faster increases in working alliance predicted less worry at the end of treatment and at follow-up, all of which only occurred in the video-support condition. Conclusions: Working alliance with the IBIs was generally established in the initial sessions. Although working alliance is conceptually invariant across IBIs with or without clinician support, the associations between working alliance and treatment outcomes among IBIs may differ depending on clinician involvement and the modalities of support. Trial Registration: ClinicalTrials.gov NCT05122429; https://clinicaltrials.gov/ct2/show/NCT05122429 %M 35727626 %R 10.2196/35496 %U https://mental.jmir.org/2022/6/e35496 %U https://doi.org/10.2196/35496 %U http://www.ncbi.nlm.nih.gov/pubmed/35727626 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 6 %P e35021 %T UK Adults’ Exercise Locations, Use of Digital Programs, and Associations with Physical Activity During the COVID-19 Pandemic: Longitudinal Analysis of Data From the Health Behaviours During the COVID-19 Pandemic Study %A Schneider,Verena %A Kale,Dimitra %A Herbec,Aleksandra %A Beard,Emma %A Fisher,Abigail %A Shahab,Lion %+ Department of Behavioural Science and Health, University College London, 1–19 Torrington Place, London, WC1E 6BT, United Kingdom, 44 20 7679 1720, verena.schneider.19@ucl.ac.uk %K pandemic %K physical activity %K longitudinal %K United Kingdom %K digital health %K tele-exercise %K moderate-to-vigorous physical activity %K muscle-strengthening activity %K COVID-19 %K home-based exercise %K exercise %K telemedicine %K longitudinal %K health behavior %K behavior %K data %D 2022 %7 21.6.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital physical activity (PA) program use has been associated with higher PA guideline adherence during COVID-19 pandemic confinements. However, little is known longitudinally about exercise locations (inside vs outside the home environment), digital program use, and their associations with moderate-to-vigorous PA (MVPA) and muscle-strengthening activities (MSAs) during the pandemic. Objective: The aims of this study were to assess the relationship between exercise location and use of digital programs with PA guideline adherence during the COVID-19 pandemic, describe how individuals exercised inside and outside of their home environments, and explore which sociodemographic and contextual factors were associated with exercise locations and digital PA program use. Methods: Active UK adults (N=1938) who participated in the 1-month follow-up survey of the Health Behaviours During the COVID-19 Pandemic (HEBECO) study (FU1, June-July 2020) and at least one more follow-up survey (FU2, August-September; FU3, November-December 2020) reported exercise locations and types of exercises inside and outside their homes, including digital programs (online/app-based fitness classes/programs), MVPA, and MSA. Generalized linear mixed models were used to assess associations of exercise location and digital PA program use with PA guideline adherence (MVPA, MSA, full [combined] adherence), and predictors of exercise location and digital program use. Results: As the pandemic progressed, active UK adults were less likely to exercise inside or to use digital PA programs compared with periods of initial confinement: 61% (95% CI 58%-63%; weighted n=1024), 50% (95% CI 48%-53%; weighted n=786), and 49% (95% CI 46%-51%; weighted n=723) performed any exercise inside their homes at FU1, FU2, and FU3, respectively. At FU1, FU2, and FU3, 22% (95% CI 21%-25%; weighted n=385), 17% (95% CI 15%-19%; weighted n=265), and 16% (95% CI 14%-18%; weighted n=241) used digital PA programs, respectively. Most participants who exercised inside already owned indoor equipment, used digital PA programs, or had their own workout routines, whereas MVPA and gentle walking were the most common exercise types performed outside the home. Being female, nonwhite, having a condition limiting PA, indoor exercising space, a lower BMI, and living in total isolation were associated with increased odds of exercising inside the home or garden compared with outside exercise only. Digital PA program users were more likely to be younger, female, highly educated, have indoor space to exercise, and a lower BMI. While exercising inside was positively associated with MSA and exercising outside was positively associated with MVPA guideline adherence, both inside (vs outside only) and outside (vs inside only) activities contributed to full PA guideline adherence (odds ratio [OR] 5.05, 95% CI 3.17-8.03 and OR 1.89, 95% CI 1.10-3.23, respectively). Digital PA program use was associated with a higher odds of MSA (OR 3.97-8.71) and full PA (OR 2.24-3.95), but not with MVPA guideline adherence. Conclusions: During the COVID-19 pandemic, full PA guideline adherence was associated with exercising inside and outside of one’s home environment and using digital PA programs. More research is needed to understand the reach, long-term adherence, and differences between digital PA solutions. %M 35584123 %R 10.2196/35021 %U https://formative.jmir.org/2022/6/e35021 %U https://doi.org/10.2196/35021 %U http://www.ncbi.nlm.nih.gov/pubmed/35584123 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 6 %P e24111 %T Effectiveness of Using Virtual Reality–Supported Exercise Therapy for Upper Extremity Motor Rehabilitation in Patients With Stroke: Systematic Review and Meta-analysis of Randomized Controlled Trials %A Chen,Jiayin %A Or,Calvin Kalun %A Chen,Tianrong %+ Department of Industrial and Manufacturing Systems Engineering, The University of Hong Kong, Room 8-7, 8/F., Haking Wong Building, Pokfulam, Hong Kong, China (Hong Kong), 852 39172587, klor@hku.hk %K virtual reality %K stroke %K rehabilitation %K upper extremity %K meta-analysis %D 2022 %7 20.6.2022 %9 Review %J J Med Internet Res %G English %X Background: In recent years, efforts have been made to implement virtual reality (VR) to support the delivery of poststroke upper extremity motor rehabilitation exercises. Therefore, it is important to review and analyze the existing research evidence of its effectiveness. Objective: Through a systematic review and meta-analysis of randomized controlled trials, this study examined the effectiveness of using VR-supported exercise therapy for upper extremity motor rehabilitation in patients with stroke. Methods: This study followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The CINAHL Plus, MEDLINE, Web of Science, Embase, and Cochrane Library databases were searched on December 31, 2021. Changes in outcomes related to impairments in upper extremity functions and structures, activity limitations, and participation restrictions in life situations from baseline to after intervention, after intervention to follow-up assessment, and baseline to follow-up assessment were examined. Standardized mean differences (SMDs) were calculated using a random-effects model. Subgroup analyses were performed to determine whether the differences in treatment outcomes depended on age, stroke recovery stage, VR program type, therapy delivery format, similarities in intervention duration between study groups, intervention duration in VR groups, and trial length. Results: A total of 42 publications representing 43 trials (aggregated sample size=1893) were analyzed. Compared with the control groups that used either conventional therapy or no therapy, the intervention groups that used VR to support exercise therapy showed significant improvements in upper extremity motor function (Fugl-Meyer Assessment-Upper Extremity; SMD 0.45, 95% CI 0.21-0.68; P<.001), range of motion (goniometer; SMD 1.01, 95% CI 0.50-1.52; P<.001), muscle strength (Manual Muscle Testing; SMD 0.79, 95% CI 0.28-1.30; P=.002), and independence in day-to-day activities (Functional Independence Measure; SMD 0.23, 95% CI 0.06-0.40; P=.01, and modified Rankin Scale; SMD 0.57, 95% CI 0.01-1.12; P=.046). Significant subgroup differences were observed in hand dexterity (Box and Block Test), spasticity (Ashworth Scale or modified Ashworth Scale), arm and hand motor ability (Wolf Motor Function Test and Manual Function Test), hand motor ability (Jebsen Hand Function Test), and quality of life (Stroke Impact Scale). There was no evidence that the benefits of VR-supported exercise therapy were maintained after the intervention ended. Conclusions: VR-supported upper extremity exercise therapy can be effective in improving motor rehabilitation results. Our review showed that of the 12 rehabilitation outcomes examined during the course of VR-based therapy, significant improvements were detected in 2 (upper extremity motor function and range of motion), and both significant and nonsignificant improvements were observed in another 2 (muscle strength and independence in day-to-day activities), depending on the measurement tools or methods used. Trial Registration: PROSPERO CRD42021256826; https://tinyurl.com/2uarftbh %M 35723907 %R 10.2196/24111 %U https://www.jmir.org/2022/6/e24111 %U https://doi.org/10.2196/24111 %U http://www.ncbi.nlm.nih.gov/pubmed/35723907 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 2 %P e31029 %T A Reference Architecture for Data-Driven and Adaptive Internet-Delivered Psychological Treatment Systems: Software Architecture Development and Validation Study %A Mukhiya,Suresh Kumar %A Lamo,Yngve %A Rabbi,Fazle %+ Western Norway University of Applied Sciences, Inndalsveien 28, 5063 Bergen, Bergen, 5063, Norway, 47 55 58 58 00, itsmeskm99@gmail.com %K software architecture %K adaptive system %K IDPT system %K health care systems %K ICBT %K adaptive strategies %K personalized therapies %K reference architecture %D 2022 %7 20.6.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Internet-delivered psychological treatment (IDPT) systems are software applications that offer psychological treatments via the internet. Such IDPT systems have become one of the most commonly practiced and widely researched forms of psychotherapy. Evidence shows that psychological treatments delivered by IDPT systems can be an effective way of treating mental health morbidities. However, current IDPT systems have high dropout rates and low user adherence. The primary reason is that the current IDPT systems are not flexible, adaptable, and personalized as they follow a fixed tunnel-based treatment architecture. A fixed tunnel-based architecture follows predefined, sequential treatment content for every patient, irrespective of their context, preferences, and needs. Moreover, current IDPT systems have poor interoperability, making it difficult to reuse and share treatment materials. There is a lack of development and documentation standards, conceptual frameworks, and established (clinical) guidelines for such IDPT systems. As a result, several ad hoc forms of IDPT models exist. Consequently, developers and researchers have tended to reinvent new versions of IDPT systems, making them more complex and less interoperable. Objective: This study aimed to design, develop, and evaluate a reference architecture (RA) for adaptive systems that can facilitate the design and development of adaptive, interoperable, and reusable IDPT systems. Methods: This study was conducted in collaboration with a large interdisciplinary project entitled INTROMAT (Introducing Mental Health through Adaptive Technology), which brings together information and communications technology researchers, information and communications technology industries, health researchers, patients, clinicians, and patients’ next of kin to reach its vision. First, we investigated previous studies and state-of-the-art works based on the project’s problem domain and goals. On the basis of the findings from these investigations, we identified 2 primary gaps in current IDPT systems: lack of adaptiveness and limited interoperability. Second, we used model-driven engineering and Domain-Driven Design techniques to design, develop, and validate the RA for building adaptive, interoperable, and reusable IDPT systems to address these gaps. Third, based on the proposed RA, we implemented a prototype as the open-source software. Finally, we evaluated the RA and open-source implementation using empirical (case study) and nonempirical approaches (software architecture analysis method, expert evaluation, and software quality attributes). Results: This paper outlines an RA that supports flexible user modeling and the adaptive delivery of treatments. To evaluate the proposed RA, we developed an open-source software based on the proposed RA. The open-source framework aims to improve development productivity, facilitate interoperability, increase reusability, and expedite communication with domain experts. Conclusions: Our results showed that the proposed RA is flexible and capable of adapting interventions based on patients’ needs, preferences, and context. Furthermore, developers and researchers can extend the proposed RA to various health care interventions. %M 35723905 %R 10.2196/31029 %U https://humanfactors.jmir.org/2022/2/e31029 %U https://doi.org/10.2196/31029 %U http://www.ncbi.nlm.nih.gov/pubmed/35723905 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 6 %P e29640 %T Possible Impact of a 12-Month Web- and Smartphone-Based Program to Improve Long-term Physical Activity in Patients Attending Spa Therapy: Randomized Controlled Trial %A Fillol,Florie %A Paris,Ludivine %A Pascal,Sébastien %A Mulliez,Aurélien %A Roques,Christian-François %A Rousset,Sylvie %A Duclos,Martine %+ Biomouv SAS Inc, 259 Rue Saint Honoré, Paris, 75001, France, 33 0664421389, florie.fillol@gmail.com %K physical activity %K spa %K mobile phone %K older adults %K internet %K exercise %K aged %K sedentary behavior %K quality of life %K follow-up studies %D 2022 %7 16.6.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Lack of physical activity (PA) and sedentary behaviors are leading risk factors for noncommunicable diseases (NCDs). Web- and smartphone-based interventions are effective in increasing PA in older adults and in patients with NCD. In many countries, spa therapy, commonly prescribed to patients with NCD, represents an ideal context to initiating lifestyle changes. Objective: This study aimed to evaluate, in patients attending spa therapy, the effectiveness of an intervention combining a face-to-face coaching and, when returning home, a web- and smartphone-based PA program on the achievement of PA guidelines (PAG) 12 months after the end of spa therapy. Methods: This was a 12-month, prospective, parallel-group randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received PA usual advice. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants were assessed by phone every 2 months. Primary outcome was meeting PAG (PA ≥600 metabolic equivalent of task) at 12 months. Secondary outcomes were meeting current PAG at 6 months; sedentary time, weight, waist circumference, PA, and quality of life at 6 and 12 months. Objective use data of the web- and smartphone-based PA program were collected. Analytic methods included intention to treat and constrained longitudinal data analyses. Results: The study sample included 228 participants (n=176, 77.2% females) with a mean age of 62.4 (SD 6.7) years and a mean BMI of 28.2 (SD 4.2) kg/m2. Approximately 53.9% (123/228) of the participants were retired. No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group than in the control group (81% vs 67% respectively, odds ratio 2.34, 95% CI 1.02-5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight, and waist circumference at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in the intervention group than in the control group (mean difference: 4.1, 95% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 (SD 4.5) months. Attrition rate during the first 2 months was 20.4% (23/113) whereas 39.8% (45/113) of the participants used the program for at least 10 months. Conclusions: PA increased in both the intervention group and the control group. However, at 12 months, more participants met PAG in the intervention group compared with the controls. This indicates that the web- and smartphone-based program could have maintained PA in the intervention group. In addition, a spa therapy seems to be an ideal time and framework to implement PA education. Trial Registration: ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796 %M 35708743 %R 10.2196/29640 %U https://www.jmir.org/2022/6/e29640 %U https://doi.org/10.2196/29640 %U http://www.ncbi.nlm.nih.gov/pubmed/35708743 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 6 %P e38113 %T Design and Preliminary Findings of Adherence to the Self-Testing for Our Protection From COVID-19 (STOP COVID-19) Risk-Based Testing Protocol: Prospective Digital Study %A Herbert,Carly %A Kheterpal,Vik %A Suvarna,Thejas %A Broach,John %A Marquez,Juan Luis %A Gerber,Ben %A Schrader,Summer %A Nowak,Christopher %A Harman,Emma %A Heetderks,William %A Fahey,Nisha %A Orvek,Elizabeth %A Lazar,Peter %A Ferranto,Julia %A Noorishirazi,Kamran %A Valpady,Shivakumar %A Shi,Qiming %A Lin,Honghuang %A Marvel,Kathryn %A Gibson,Laura %A Barton,Bruce %A Lemon,Stephenie %A Hafer,Nathaniel %A McManus,David %A Soni,Apurv %+ Division of Clinical Informatics, Department of Medicine, University of Massachusetts Chan Medical School, 55 Lake Avenue North, Worcester, MA, 01655, United States, 1 774 442 4107, apurv.soni@umassmed.edu %K COVID-19 %K rapid antigen tests %K COVID-19 testing %K infectious disease %K disease spread %K prevention %K coronavirus %K adherence %K reporting %K mHealth %K health application %K mobile health %K digital health %K public health %K surveillance %K health care %K smartphone app %K vaccination %K digital surveillance %D 2022 %7 16.6.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Serial testing for SARS-CoV-2 is recommended to reduce spread of the virus; however, little is known about adherence to recommended testing schedules and reporting practices to health departments. Objective: The Self-Testing for Our Protection from COVID-19 (STOP COVID-19) study aims to examine adherence to a risk-based COVID-19 testing strategy using rapid antigen tests and reporting of test results to health departments. Methods: STOP COVID-19 is a 12-week digital study, facilitated using a smartphone app for testing assistance and reporting. We are recruiting 20,000 participants throughout the United States. Participants are stratified into high- and low-risk groups based on history of COVID-19 infection and vaccination status. High-risk participants are instructed to perform twice-weekly testing for COVID-19 using rapid antigen tests, while low-risk participants test only in the case of symptoms or exposure to COVID-19. All participants complete COVID-19 surveillance surveys, and rapid antigen results are recorded within the smartphone app. Primary outcomes include participant adherence to a risk-based serial testing protocol and percentage of rapid tests reported to health departments. Results: As of February 2022, 3496 participants have enrolled, including 1083 high-risk participants. Out of 13,730 tests completed, participants have reported 13,480 (98.18%, 95% CI 97.9%-98.4%) results to state public health departments with full personal identifying information or anonymously. Among 622 high-risk participants who finished the study period, 35.9% showed high adherence to the study testing protocol. Participants with high adherence reported a higher percentage of test results to the state health department with full identifying information than those in the moderate- or low-adherence groups (high: 71.7%, 95% CI 70.3%-73.1%; moderate: 68.3%, 95% CI 66.0%-70.5%; low: 63.1%, 59.5%-66.6%). Conclusions: Preliminary results from the STOP COVID-19 study provide important insights into rapid antigen test reporting and usage, and can thus inform the use of rapid testing interventions for COVID-19 surveillance. %M 35649180 %R 10.2196/38113 %U https://formative.jmir.org/2022/6/e38113 %U https://doi.org/10.2196/38113 %U http://www.ncbi.nlm.nih.gov/pubmed/35649180 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 6 %P e36004 %T The Effects of Nonclinician Guidance on Effectiveness and Process Outcomes in Digital Mental Health Interventions: Systematic Review and Meta-analysis %A Leung,Calista %A Pei,Julia %A Hudec,Kristen %A Shams,Farhud %A Munthali,Richard %A Vigo,Daniel %+ Department of Psychiatry, Faculty of Medicine, University of British Columbia, 2255 Wesbrook Mall, Vancouver, BC, V6T2B8, Canada, 1 6048228048, daniel.vigo@ubc.ca %K digital mental health %K nonclinician guidance %K e-Mental health intervention %K internet-based intervention %K mental health %K task shifting %K digital health %K digital health intervention %K patient outcome %D 2022 %7 15.6.2022 %9 Review %J J Med Internet Res %G English %X Background: Digital mental health interventions are increasingly prevalent in the current context of rapidly evolving technology, and research indicates that they yield effectiveness outcomes comparable to in-person treatment. Integrating professionals (ie, psychologists and physicians) into digital mental health interventions has become common, and the inclusion of guidance within programs can increase adherence to interventions. However, employing professionals to enhance mental health programs may undermine the scalability of digital interventions. Therefore, delegating guidance tasks to paraprofessionals (peer supporters, technicians, lay counsellors, or other nonclinicians) can help reduce costs and increase accessibility. Objective: This systematic review and meta-analysis evaluates the effectiveness, adherence, and other process outcomes of nonclinician-guided digital mental health interventions. Methods: Four databases (MEDLINE, Embase, CINAHL, and PsycINFO) were searched for randomized controlled trials published between 2010 and 2020 examining digital mental health interventions. Three journals that focus on digital intervention were hand searched; gray literature was searched using ProQuest and the Cochrane Central Register of Control Trials (CENTRAL). Two researchers independently assessed risk of bias using the Cochrane risk-of-bias tool version 2. Data were collected on effectiveness, adherence, and other process outcomes, and meta-analyses were conducted for effectiveness and adherence outcomes. Nonclinician-guided interventions were compared with treatment as usual, clinician-guided interventions, and unguided interventions. Results: Thirteen studies qualified for inclusion. Nonclinician-guided interventions yielded higher posttreatment effectiveness outcomes when compared to conditions involving control programs (eg, online psychoeducation and monitored attention control) or wait-list controls (k=7, Hedges g=–0.73; 95% CI –1.08 to –0.38). There were also significant differences between nonclinician-guided interventions and unguided interventions (k=6, Hedges g=–0.17; 95% CI –0.23 to –0.11). In addition, nonclinician-guided interventions did not differ in effectiveness from clinician-guided interventions (k=3, Hedges g=0.08; 95% CI –0.01 to 0.17). These results suggest that guided digital mental health interventions are helpful to improve mental health outcomes regardless of the qualifications of the individual performing the intervention, and that the presence of a nonclinician guide improves effectiveness outcomes compared to having no guide. Nonclinician-guided interventions did not yield significantly different adherence outcomes when compared with unguided interventions (k=3, odds ratio 1.58; 95% CI 0.51 to 4.92), although a general trend of improved adherence was observed within nonclinician-guided interventions. Conclusions: Integrating paraprofessionals and nonclinicians appears to improve the outcomes of digital mental health interventions, and may also enhance adherence outcomes (though this trend was nonsignificant). Further research should focus on the specific types of tasks these paraprofessionals can successfully provide (ie, psychosocial support, therapeutic alliance, and technical augmentation) and their associated outcomes. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020191226; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=191226 %M 35511463 %R 10.2196/36004 %U https://www.jmir.org/2022/6/e36004 %U https://doi.org/10.2196/36004 %U http://www.ncbi.nlm.nih.gov/pubmed/35511463 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 6 %P e37874 %T Impact of Web-Based Cognitive Behavioral Therapy for Insomnia on Stress, Health, Mood, Cognitive, Inflammatory, and Neurodegenerative Outcomes in Rural Dementia Caregivers: Protocol for the NiteCAPP CARES and NiteCAPP SHARES Randomized Controlled Trial %A McCrae,Christina S %A Curtis,Ashley F %A Cottle,Amelia %A Beversdorf,David B %A Shenker,Joel %A Mooney,Brian P %A Popescu,Mihail %A Rantz,Marilyn %A Groer,Maureen %A Stein,Phyllis %A Golzy,Mojgan %A Stearns,Melanie A %A Simenson,Angelynn %A Nair,Neetu %A Rowe,Meredeth A %+ University of Missouri, 1 Hospital Drive, Columbia, MO, 65212, United States, 1 573 882 0982, mccraec@health.missouri.edu %K caregiver %K CBT-I %K cognition %K dementia %K inflammation %K insomnia %K neurodegeneration %D 2022 %7 14.6.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic insomnia affects up to 63% of family dementia caregivers. Research suggests that chronic insomnia prompts changes in central stress processing that have downstream negative effects on health and mood, as well as on cognitive, inflammatory, and neurodegenerative functioning. We hypothesize that cognitive behavioral therapy for insomnia (CBT-I) will reverse those downstream effects by improving insomnia and restoring healthy central stress processing. Rural caregivers are particularly vulnerable, but they have limited access to CBT-I; therefore, we developed an accessible digital version using community input (NiteCAPP CARES). Objective: This trial will evaluate the acceptability, feasibility, and short-term and long-term effects of NiteCAPP CARES on the sleep and stress mechanisms underlying poor caregiver health and functioning. Methods: Dyads (n=100) consisting of caregivers with chronic insomnia and their coresiding persons with dementia will be recruited from Columbia and surrounding areas in Missouri, United States. Participant dyads will be randomized to 4 weeks (plus 4 bimonthly booster sessions) of NiteCAPP CARES or a web-based sleep hygiene control (NiteCAPP SHARES). Participants will be assessed at baseline, after treatment, and 6- and 12-month follow-ups. The following assessments will be completed by caregivers: 1 week of actigraphy and daily diaries measuring sleep, Insomnia Severity Index, arousal (heart rate variability), inflammation (blood-derived biomarkers: interleukin-6 and C-reactive protein), neurodegeneration (blood-derived biomarkers: plasma amyloid beta [Aβ40 and Aβ42], total tau, and phosphorylated tau [p-tau181 and p-tau217]), cognition (Joggle battery, NIH Toolbox for Assessment of Neurological and Behavioral Function, and Cognitive Failures Questionnaire), stress and burden, health, and mood (depression and anxiety). Persons with dementia will complete 1 week of actigraphy at each time point. Results: Recruitment procedures started in February 2022. All data are expected to be collected by 2026. Full trial results are planned to be published by 2027. Secondary analyses of baseline data will be subsequently published. Conclusions: This randomized controlled trial tests NiteCAPP CARES, a web-based CBT-I for rural caregivers. The knowledge obtained will address not only what outcomes improve but also how and why they improve and for how long, which will help us to modify NiteCAPP CARES to optimize treatment potency and support future pragmatic testing and dissemination. Trial Registration: ClinicalTrials.gov NCT04896775; https://clinicaltrials.gov/ct2/show/NCT04896775 International Registered Report Identifier (IRRID): PRR1-10.2196/37874 %M 35700020 %R 10.2196/37874 %U https://www.researchprotocols.org/2022/6/e37874 %U https://doi.org/10.2196/37874 %U http://www.ncbi.nlm.nih.gov/pubmed/35700020 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 6 %P e34706 %T Internet-Based Prevention Program of Victimization for Youth in Care and Care Leavers (EMPOWER YOUTH): Protocol for a Randomized Controlled Trial %A Wagner,Birgit %A Reuter,Laurence %A van Noort,Betteke Maria %+ Department of Psychology, Medical School Berlin, Rüdesheimer Str. 50, Berlin, 14197, Germany, 49 30 7668375841, birgit.wagner@medicalschool-berlin.de %K foster care %K youth in care %K victimization %K prevention %K online program %D 2022 %7 14.6.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: The global estimate of the number of children in institutional care is around 5 million, with around 1 million of these children living in Europe. In Germany, about 75,000 children and adolescents find themselves in the foster care system and about 93,000 additional children and adolescents are living in institutions. Traumatic experiences and neglect in childhood are highly prevalent among these youth in care and are related to severe long-term effects. Childhood maltreatment and abuse can increase the risk of future victimization experiences. Although youth in care are at risk of victimization or revictimization, no specific evidence-based prevention program has been designed to address these specific needs. Objective: This study aims to evaluate the efficacy of a newly developed 6-module internet-based prevention program of victimization for youth in care, named EMPOWER YOUTH. Methods: In a randomized controlled trial, the intervention group will be compared to a waiting-list control group with an unblinded 1:1 allocation ratio. Assessments will take place before randomization (baseline) and at follow-up 18 weeks after baseline (ie, 12 weeks after finishing the last module of the program). The primary endpoint is the number of victimization, and online and offline bullying experiences (composite score) at the 18-week follow-up. Secondary endpoints are risk-taking behavior, aggressive tendencies, empathy, prosocial behavior, depressiveness, and loneliness at follow-up. The expected outcome requires a sample size of 156 subjects to achieve a power of 80%. Assuming a 30% dropout rate at follow-up, we require 225 participants to be allocated to the trial. Participants are youth in care, that is, adolescents in foster care, adopted adolescents, or young care leavers aged 14 to 21 years. Results: Ethical approval was granted by the Ethics Committee of the Medical School Berlin in March 2021 (MSB-2021/55). Recruitment started in September 2021 and is planned until November 2022. The results are expected to be published in January 2023. Conclusions: Given the increased likelihood for future victimization experiences among youth in care, there is a strong need for a low-threshold intervention specifically for this high-risk age group. There are no existing nationwide mental health programs exclusively for youth in care in Germany. Trial Registration: German Clinical Trials Register DRKS00024749; https://tinyurl.com/tjaahayw International Registered Report Identifier (IRRID): DERR1-10.2196/34706 %M 35700035 %R 10.2196/34706 %U https://www.researchprotocols.org/2022/6/e34706 %U https://doi.org/10.2196/34706 %U http://www.ncbi.nlm.nih.gov/pubmed/35700035 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 10 %N 2 %P e32218 %T The Role of Agency and Threat Immediacy in Interactive Digital Narrative Fear Appeals for the Prevention of Excessive Alcohol Use: Randomized Controlled Trial %A Engelbrecht,Hendrik %A van der Laan,Laura Nynke %A van Enschot,Renske %A Krahmer,Emiel %+ Tilburg School of Humanities and Digital Sciences, Tilburg University, Warandelaan 2, Tilburg, 5037AB, Netherlands, 31 134663383, h.engelbrecht@tilburguniversity.edu %K young adults %K college students %K alcohol abuse %K drinking %K EPPM %K fear appeals %K agency %K serious games %D 2022 %7 13.6.2022 %9 Original Paper %J JMIR Serious Games %G English %X Background: Serious games for the training of prevention behaviors have been widely recognized as potentially valuable tools for adolescents and young adults across a variety of risk behaviors. However, the role of agency as a distinguishing factor from traditional health interventions has seldom been isolated and grounded in the persuasive health communication theory. Fear appeals have different effects on intentions to perform prevention behaviors depending on the immediacy of the consequences. Looking into how to increase self-efficacy beliefs for health behavior with distant consequences is the first step toward improving game-based interventions for adverse health outcomes. Objective: This study aimed to investigate the effect of agency on self-efficacy and the intention to drink less alcohol in an interactive digital narrative fear appeal. Furthermore, the communicated immediacy of threat outcomes was evaluated as a potential moderator of the effect of agency on self-efficacy. Methods: A web-based experimental study was conducted with university students (N=178). The participants were presented with a fear appeal outlining the consequences of excessive alcohol use in a fully automated web-based interactive narrative. Participants either had perceived control over the outcome of the narrative scenario (high agency) or no control over the outcome (low agency). The threat was either framed as a short-term (high immediacy) or long-term (low immediacy) negative health outcome resulting from the execution of the risk behavior (drinking too much alcohol). Results: A total of 123 valid cases were analyzed. Self-efficacy and intention to limit alcohol intake were not influenced by the agency manipulation. Self-efficacy was shown to be a significant predictor of behavioral intention. The immediacy of the threat did not moderate the relationship between agency and self-efficacy. Conclusions: Although agency manipulation was successful, we could not find evidence of an effect of agency or threat immediacy on self-efficacy. The implications for different operationalizations of different agency concepts, as well as the malleability of self-efficacy beliefs for long-term threats, are discussed. The use of repeated versus single interventions and different threat types (eg, health and social threats) should be tested empirically to establish a way forward for diversifying intervention approaches. Trial Registration: ClinicalTrials.gov NCT05321238; https://www.clinicaltrials.gov/ct2/show/NCT05321238 %M 35699976 %R 10.2196/32218 %U https://games.jmir.org/2022/2/e32218 %U https://doi.org/10.2196/32218 %U http://www.ncbi.nlm.nih.gov/pubmed/35699976 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 6 %P e36012 %T Effectiveness and Cost-effectiveness of Online Brief Mindfulness-based Cognitive Therapy for the Improvement of Productivity in the Workplace: Study Protocol for a Randomized Controlled Trial %A Sado,Mitsuhiro %A Yamada,Masashi %A Ninomiya,Akira %A Nagaoka,Maki %A Goto,Naho %A Koreki,Akihiro %A Nakagawa,Atsuo %A Segal,Zindel %A Mimura,Masaru %+ Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 1608582, Japan, 81 0333531211 ext 62454, mitsusado@keio.jp %K mindfulness-based cognitive therapy %K mindfulness %K cognitive therapy %K occupational health %K workplace %K randomized controlled trial %K cost-effectiveness %K cost %K online %K internet-based %K eHealth %K mental health %K heath outcome %K work %K stress %K burnout %K productivity %K employee %D 2022 %7 13.6.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Numerous studies have demonstrated the effectiveness of mindfulness-based programs (MBPs) among both clinical and nonclinical populations. These data document positive impacts in the workplace, including reducing perceived stress and burnout and increasing well-being. However, the effectiveness for productivity, which is of most interest to managers and administrators, is still unclear. In addition, MBPs in the workplace tend to be modified by reducing the number of the program sessions or delivering content online to improve accessibility. To date, however, the impact of MBPs that feature these modifications on productivity in the workplace has not been investigated. Objective: The study aims to investigate the effectiveness and cost-effectiveness of online-delivered brief mindfulness-based cognitive therapy (bMBCT) for improving productivity and other work-related outcomes among healthy workers compared to the waitlist control. Methods: We will conduct a 4-week randomized controlled trial (RCT) with a 6-month follow-up. Employees are included in the study if they (1) are between the ages of 20 and 65 years and (2) work longer than 30 hours weekly. Employees are randomly allocated to either the bMBCT group or the waitlist control group. The primary outcome of the study is the mean difference of productivity measured by the World Health Organization Health and Work Performance Questionnaire (WHO-HPQ) between the groups at 4, 16, and 28 weeks. Secondary outcomes include several clinical outcomes and health economics evaluation. Results: We started recruiting participants in August 2021, and the intervention began in October 2021. A total of 104 participants have been enrolled in the study as of October 2021. The intervention is scheduled to be completed in December 2023. Data collection will be completed by the end of January 2024. Conclusions: The novelty of the study is that (1) it will investigate bMBCT’s effectiveness on productivity, which is still unclear, and (2) samples are recruited from 3 companies in different industries. The limitations of the study are that (1) all measures assessed are in self-report format and (2) we lack an active control group. This study has the potential to provide new data on the relationship between MBPs and occupational health and productivity. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000044721; https://tinyurl.com/4e2fh873 International Registered Report Identifier (IRRID): DERR1-10.2196/36012 %M 35387762 %R 10.2196/36012 %U https://www.researchprotocols.org/2022/6/e36012 %U https://doi.org/10.2196/36012 %U http://www.ncbi.nlm.nih.gov/pubmed/35387762 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 6 %P e36826 %T Evaluation of the Web-Based OutsidePlay-ECE Intervention to Influence Early Childhood Educators’ Attitudes and Supportive Behaviors Toward Outdoor Play: Randomized Controlled Trial %A Brussoni,Mariana %A Han,Christina S %A Lin,Yingyi %A Jacob,John %A Munday,Fritha %A Zeni,Megan %A Walters,Melanie %A Oberle,Eva %+ Department of Pediatrics, Faculty of Medicine, University of British Columbia, 4480 Oak St, Vancouver, BC, V6H 0B3, Canada, 1 604 875 3712, mbrussoni@bcchr.ubc.ca %K risk perception %K risky play %K risk reframing %K early childhood education %K tolerance of risk in play %K child care %K outside play %K preschool %D 2022 %7 10.6.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Outdoor play is critical to children’s healthy development and well-being. Early learning and childcare centers (ELCCs) are important venues for increasing children’s outdoor play opportunities, and early childhood educators’ (ECE) perception of outdoor play can be a major barrier to outdoor play. The OutsidePlay-ECE risk-reframing intervention is a fully automated and open access web-based intervention to reframe ECEs’ perceptions of the importance of outdoor play and risk in play and to promote a change in their practice in supporting it in ELCC settings. We grounded the intervention in social cognitive theory and behavior change techniques. Objective: The aim of this study is to evaluate the effectiveness of the OutsidePlay-ECE web-based risk-reframing intervention. Methods: We conducted a single-blind randomized controlled trial in Canada between December 2020 and June 2021 to test the OutsidePlay-ECE risk-reframing intervention for ECEs. We recruited participants using social media and mass emails through our partner and professional networks. We invited ECEs and administrators working in an ELCC, who can speak, read, and understand English. We randomized consented participants to the intervention or control condition. The participants allocated to the intervention condition received a link to the OutsidePlay-ECE intervention. Participants allocated to the control condition read the Position Statement on Active Outdoor Play, a 4-page document on research and recommendations for action in addressing barriers to outdoor play. The primary outcome was a change in tolerance of risk in play. The secondary outcome was goal attainment. We collected data on the web via REDCap (Vanderbilt University) at baseline and 1 week and 3 months after intervention. Results: A total of 563 participants completed the baseline survey, which assessed their demographics and tolerance of risk in play. They were then randomized: 281 (49.9%) to the intervention and 282 (50.1%) to the control condition. Of these, 136 (48.4%) and 220 (78%) participants completed the baseline requirements for the intervention and control conditions, respectively. At 1 week after intervention, 126 (44.8%) and 209 (74.1%) participants completed follow-up assessments, respectively, and at 3 months after intervention, 119 (42.3%) and 195 (69.1%) participants completed the assessments, respectively. Compared with participants in the control condition, participants in the intervention group had significantly higher tolerance of risk in play at 1 week (β=.320; P=.001) and 3 months after intervention (β=.251; P=.009). Intention-to-treat analyses replicated these findings (β=.335; P<.001 and β=.271; P=.004, respectively). No significant intervention effect was found for goal attainment outcomes (odds ratio 1.124, 95% CI 0.335-3.774; P=.85). Conclusions: The results of this randomized controlled trial demonstrated that the OutsidePlay-ECE intervention was effective and had a sustained effect in increasing ECEs’ and administrators’ tolerance of risk in play. It was not effective in increasing goal attainment. Trial Registration: ClinicalTrials.gov NCT04624932; https://clinicaltrials.gov/ct2/show/NCT04624932 International Registered Report Identifier (IRRID): RR2-10.2196/31041 %M 35687394 %R 10.2196/36826 %U https://www.jmir.org/2022/6/e36826 %U https://doi.org/10.2196/36826 %U http://www.ncbi.nlm.nih.gov/pubmed/35687394 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 6 %P e35260 %T Internet-Delivered Cognitive Behavioral Therapy in Patients With Irritable Bowel Syndrome: Systematic Review and Meta-Analysis %A Kim,Hyunjung %A Oh,Younjae %A Chang,Sun Ju %+ College of Nursing, Research Institute of Nursing Science, Seoul National University, 103 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea, 82 10 5226 8262, changsj@snu.ac.kr %K cognitive behavioral therapy %K irritable bowel syndrome %K internet %K symptom %K quality of life %D 2022 %7 10.6.2022 %9 Review %J J Med Internet Res %G English %X Background: Irritable bowel syndrome is a common functional gastrointestinal disorder that negatively affects all aspects of life. With the widespread use of the internet, internet-delivered cognitive behavioral therapy has been developed and applied to control symptoms and improve the quality of life of those with irritable bowel syndrome. However, few studies have systematically reviewed the effectiveness of internet-delivered cognitive behavioral therapy on irritable bowel syndrome. Objective: This study aimed to systematically review studies that examined the use of internet-delivered cognitive behavioral therapy in patients with irritable bowel syndrome and to evaluate the effects of internet-delivered cognitive behavioral therapy on the improvement of symptom severity, quality of life, psychological status, and cost-effectiveness. Methods: This meta-analysis involved the search of 6 databases for relevant publications. From the 1224 publications identified through database searches, 9 randomized controlled trials were finally included in the analysis. Results: The internet-delivered cognitive behavioral therapies including exposure-based cognitive behavioral therapy, cognitive behavioral therapy for self-management, and cognitive behavioral therapy for stress management were provided in 5 to 13 sessions for 5 to 10 weeks. Internet-delivered cognitive behavioral therapy had medium-to-large effects on symptom severity (standardized mean difference [SMD] –0.633; 95% CI –0.861 to –0.4304), quality of life (SMD 0.582; 95% CI 0.396-0.769), and cost-effectiveness (–0.372; 95% CI –0.704 to –0.039) at postintervention. The effects on symptom severity remained over time even after the intervention, short-term follow-up (SMD –0.391; 95% CI –0.560 to –0.221), and long-term follow-up (SMD –0.357; 95% CI –0.541 to –0.172). There was no significant difference in psychological status, including anxiety and depression, in those with irritable bowel syndrome compared to the controls during the postintervention period. Conclusions: This review demonstrates that internet-delivered cognitive behavioral therapy could be a cost-effective intervention for improving symptoms and the quality of life in patients with irritable bowel syndrome. However, studies are still insufficient regarding the use of internet-delivered cognitive behavioral therapy in these patients; therefore, more high-quality studies are required in the future. %M 35687389 %R 10.2196/35260 %U https://www.jmir.org/2022/6/e35260 %U https://doi.org/10.2196/35260 %U http://www.ncbi.nlm.nih.gov/pubmed/35687389 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 6 %P e31485 %T Toward Improved Treatment and Empowerment of Individuals With Parkinson Disease: Design and Evaluation of an Internet of Things System %A Karni,Liran %A Jusufi,Ilir %A Nyholm,Dag %A Klein,Gunnar Oskar %A Memedi,Mevludin %+ Centre for Empirical Research on Information Systems, Örebro University School of Business, Fakultetsgatan 1, Örebro, 702 81, Sweden, 46 19 301218, liran.karni@oru.se %K Internet of Things %K wearable technology %K Parkinson disease %K patient empowerment %K objective measures %K self-assessment %K self-management %K web interface %D 2022 %7 9.6.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Parkinson disease (PD) is a chronic degenerative disorder that causes progressive neurological deterioration with profound effects on the affected individual’s quality of life. Therefore, there is an urgent need to improve patient empowerment and clinical decision support in PD care. Home-based disease monitoring is an emerging information technology with the potential to transform the care of patients with chronic illnesses. Its acceptance and role in PD care need to be elucidated both among patients and caregivers. Objective: Our main objective was to develop a novel home-based monitoring system (named EMPARK) with patient and clinician interface to improve patient empowerment and clinical care in PD. Methods: We used elements of design science research and user-centered design for requirement elicitation and subsequent information and communications technology (ICT) development. Functionalities of the interfaces were the subject of user-centric multistep evaluation complemented by semantic analysis of the recorded end-user reactions. The ICT structure of EMPARK was evaluated using the ICT for patient empowerment model. Results: Software and hardware system architecture for the collection and calculation of relevant parameters of disease management via home monitoring were established. Here, we describe the patient interface and the functional characteristics and evaluation of a novel clinician interface. In accordance with our previous findings with regard to the patient interface, our current results indicate an overall high utility and user acceptance of the clinician interface. Special characteristics of EMPARK in key areas of interest emerged from end-user evaluations, with clear potential for future system development and deployment in daily clinical practice. Evaluation through the principles of ICT for patient empowerment model, along with prior findings from patient interface evaluation, suggests that EMPARK has the potential to empower patients with PD. Conclusions: The EMPARK system is a novel home monitoring system for providing patients with PD and the care team with feedback on longitudinal disease activities. User-centric development and evaluation of the system indicated high user acceptance and usability. The EMPARK infrastructure would empower patients and could be used for future applications in daily care and research. %M 35679097 %R 10.2196/31485 %U https://formative.jmir.org/2022/6/e31485 %U https://doi.org/10.2196/31485 %U http://www.ncbi.nlm.nih.gov/pubmed/35679097 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 6 %P e32396 %T A Pharmacy-Based eHealth Intervention Promoting Correct Use of Medication in Patients With Asthma and COPD: Nonrandomized Pre-Post Study %A Schnoor,Kyma %A Versluis,Anke %A Bakema,Robbert %A van Luenen,Sanne %A Kooij,Marcel J %A van den Heuvel,J Maurik %A Teichert,Martina %A Honkoop,Persijn J %A van Boven,Job F M %A Chavannes,Niels H %A Aardoom,Jiska J %+ Department of Public Health and Primary Care, Leiden University Medical Center, Hippocratespad 21, Postzone V0-P, PO Box 9600, Leiden, , Netherlands, 31 7152668605, j.j.aardoom@lumc.nl %K asthma %K COPD %K medication adherence %K exacerbations %K pharmacy %K eHealth %D 2022 %7 8.6.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Asthma and chronic obstructive pulmonary disease (COPD) affect millions of people worldwide. While medication can control and improve disease symptoms, incorrect use of medication is a common problem. The eHealth intervention SARA (Service Apothecary Respiratory Advice) aims to improve participants’ correct use of inhalation medication by providing information and as-needed tailored follow-up support by a pharmacist. Objective: The primary aim of this study was to investigate the effect of SARA on exacerbation rates in participants with asthma and COPD. Secondary aims were to investigate its effects in terms of adherence to maintenance medication and antimycotic treatment. Methods: In this nonrandomized pre-post study, medication dispensing data from 382 Dutch community pharmacies were included. Exacerbation rates were assessed with dispensed short-course oral corticosteroids. Medication adherence between new and chronic users was assessed by calculating the proportion of days covered from dispensed inhalation maintenance medication. Antimycotic treatment was investigated from dispensed oral antimycotics in participants who were also dispensed inhaled corticosteroids (ICS). Outcomes were assessed 1 year before and 1 year after implementation of SARA and were compared between SARA participants and control participants. More specifically, for exacerbation rates and medication adherence, a difference score was calculated (ie, 1 year after SARA minus 1 year before SARA) and was subsequently compared between the study groups with independent-samples t tests. For antimycotics, the relative number of participants who were dispensed antimycotics was calculated and subsequently analyzed with a mixed-effects logistic regression. Results: The study population comprised 9452 participants, of whom 2400 (25.39%) were SARA participants. The mean age of the population was 60.8 (15.0) years, and approximately two-thirds (n=5677, 60.06%) were female. The results showed an increase in mean exacerbation rates over time for both study groups (SARA: 0.05; control: 0.15). However, this increase in exacerbation rates was significantly lower for SARA participants (t9450=3.10, 95% CI 0.04-0.16; P=.002; Cohen d=0.06). Chronic users of inhalation medication in both study groups showed an increase in mean medication adherence over time (SARA: 6.73; control: 4.48); however, this increase was significantly higher for SARA participants (t5886=–2.74, 95% CI –3.86 to –0.84; P=.01; Cohen d=–0.07). Among new users of inhalation medication, results showed no significant difference in medication adherence between SARA and control participants in the year after implementation of SARA (t1434=–1.85, 95% CI –5.60 to 0.16; P=.06; Cohen d=–0.10). Among ICS users, no significant differences between the study groups were found over time in terms of the proportion of participants who were dispensed antimycotics (t5654=0.29, 95% CI –0.40 to 0.54; P=.76; Cohen d=0). Conclusions: This study provides preliminary evidence that the SARA eHealth intervention might have the potential to decrease exacerbation rates and improve medication adherence among patients with asthma and COPD. %M 35675120 %R 10.2196/32396 %U https://www.jmir.org/2022/6/e32396 %U https://doi.org/10.2196/32396 %U http://www.ncbi.nlm.nih.gov/pubmed/35675120 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 6 %P e35747 %T mHealth Research for Weight Loss, Physical Activity, and Sedentary Behavior: Bibliometric Analysis %A Wu,Chieh-Chen %A Huang,Chih-Wei %A Wang,Yao-Chin %A Islam,Md.Mohaimenul %A Kung,Woon-Man %A Weng,Yung-Ching %A Su,Chun-Hsien %+ Graduate Institute of Sport Coaching Science, College of Kinesiology and Health, Chinese Culture University, No. 55, Hwa-Kang Road, Yang-Ming-Shan, Taipei, 11114, Taiwan, 886 2 2861 0511, chsu@ulive.pccu.edu.tw %K mobile health %K weight loss %K physical activity %K sedentary behavior %K bibliometric analysis %K mHealth %K weight %K behavior %K research %K literature %K bibliometric %K journal %K trend %K app %D 2022 %7 8.6.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Research into mobile health (mHealth) technologies on weight loss, physical activity, and sedentary behavior has increased substantially over the last decade; however, no research has been published showing the research trend in this field. Objective: The purpose of this study was to provide a dynamic and longitudinal bibliometric analysis of recent trends of mHealth research for weight loss, physical activity, and sedentary behavior. Methods: A comprehensive search was conducted through Web of Science to retrieve all existing relevant documents published in English between January 1, 2010, and November 1, 2021. We developed appropriate research questions; based on the proven bibliometric approaches, a search strategy was formulated to screen the title for eligibility. Finally, we conducted bibliometric analyses to explore the growth rate of publications; publication patterns; and the most productive authors, institutions, and countries, and visualized the trends in the field using a keyword co-occurrence network. Results: The initial search identified 8739 articles, of which 1035 were included in the analyses. Our findings show an exponential growth trend in the number of annual publications of mHealth technology research in these fields. JMIR mHealth and uHealth (n=214, 20.67%), Journal of Medical Internet Research (n=71, 6.86%), and BMC Public Health (n=36, 3.47%) were the top 3 journals, publishing higher numbers of articles. The United States remained the leading contributor in these areas (n=405, 39.13%), followed by Australia (n=154, 14.87%) and England (n=125, 12.07%). Among the universities, the University of Sydney (n=36, 3.47%) contributed the most mHealth technology research in these areas; however, Deakin University (n=25, 2.41%) and the National University of Singapore (n=23, 2.22%) were in the second and third positions, respectively. Conclusions: Although the number of papers published on mobile technologies for weight loss, physical activity, and sedentary behavior was initially low, there has been an overall increase in these areas in recent years. The findings of the study indicate that mobile apps and technologies have substantial potential to reduce weight, increase physical activity, and change sedentary behavior. Indeed, this study provides a useful overview of the publication trends and valuable guidance on future research directions and perspectives in this rapidly developing field. %M 35675126 %R 10.2196/35747 %U https://www.jmir.org/2022/6/e35747 %U https://doi.org/10.2196/35747 %U http://www.ncbi.nlm.nih.gov/pubmed/35675126 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 6 %P e30817 %T Measurement of Adherence to mHealth Physical Activity Interventions and Exploration of the Factors That Affect the Adherence: Scoping Review and Proposed Framework %A Yang,Yang %A Boulton,Elisabeth %A Todd,Chris %+ School of Health Sciences, Faculty of Biology, Medicine & Health, University of Manchester, Jean McFarlane Building, Manchester, M13 9PL, United Kingdom, 44 07422943521, yang.yang-3@manchester.ac.uk %K mobile health %K mHealth %K physical activity %K adherence %K framework %K scoping review %K mobile phone %D 2022 %7 8.6.2022 %9 Review %J J Med Internet Res %G English %X Background: Mobile health (mHealth) is widely used as an innovative approach to delivering physical activity (PA) programs. Users’ adherence to mHealth programs is important to ensure the effectiveness of mHealth-based programs. Objective: Our primary aim was to review the literature on the methods used to assess adherence, factors that could affect users’ adherence, and the investigation of the association between adherence and health outcomes. Our secondary aim was to develop a framework to understand the role of adherence in influencing the effectiveness of mHealth PA programs. Methods: MEDLINE, PsycINFO, EMBASE, and CINAHL databases were searched to identify studies that evaluated the use of mHealth to promote PA in adults aged ≥18 years. We used critical interpretive synthesis methods to summarize the data collected. Results: In total, 54 papers were included in this review. We identified 31 specific adherence measurement methods, which were summarized into 8 indicators; these indicators were mapped to 4 dimensions: length, breadth, depth, and interaction. Users’ characteristics (5 factors), technology-related factors (12 factors), and contextual factors (1 factor) were reported to have impacts on adherence. The included studies reveal that adherence is significantly associated with intervention outcomes, including health behaviors, psychological indicators, and clinical indicators. A framework was developed based on these review findings. Conclusions: This study developed an adherence framework linking together the adherence predictors, comprehensive adherence assessment, and clinical effectiveness. This framework could provide evidence for measuring adherence comprehensively and guide further studies on adherence to mHealth-based PA interventions. Future research should validate the utility of this proposed framework. %M 35675111 %R 10.2196/30817 %U https://www.jmir.org/2022/6/e30817 %U https://doi.org/10.2196/30817 %U http://www.ncbi.nlm.nih.gov/pubmed/35675111 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 6 %P e30630 %T Evaluation of Dietary Management Using Artificial Intelligence and Human Interventions: Nonrandomized Controlled Trial %A Okaniwa,Fusae %A Yoshida,Hiroshi %+ Department of Theoretical Social Security Research, National Institute of Population and Social Security Research, 2-2-3 Uchisaiwaicho, Chiyoda-ku, Tokyo, 100-0011, Japan, 81 3 3595 2984, okaniwa-fusae@ipss.go.jp %K health promotion %K dietary management %K intervention %K artificial intelligence %K body fat percentage %K body mass index %K behavioral economics %K nonprofessional %K Japan %D 2022 %7 8.6.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: There has been an increase in personal health records with the increased use of wearable devices and smartphone apps to improve health. Traditional health promotion programs by human professionals have limitations in terms of cost and reach. Due to labor shortages and to save costs, there has been a growing emphasis in the medical field on building health guidance systems using artificial intelligence (AI). AI will replace advanced human tasks to some extent in the future. However, it is difficult to sustain behavioral change through technology alone at present. Objective: This study investigates whether AI alone can effectively encourage healthy behaviors or whether human interventions are needed to achieve and sustain health-related behavioral change. We examined the effectiveness of AI and human interventions to encourage dietary management behaviors. In addition, we elucidated the conditions for maximizing the effect of AI on health improvement. We hypothesized that the combination of AI and human interventions will maximize their effectiveness. Methods: We conducted a 3-month experiment by recruiting participants who were users of a smartphone diet management app. We recruited 102 participants and divided them into 3 groups. Treatment group I received text messages using the standard features of the app (AI-based text message intervention). Treatment group II received video messages from a companion, in addition to the text messages (combined text message and human video message intervention by AI). The control group used the app to keep a dietary record, but no feedback was provided (no intervention). We examine the participants’ continuity and the effects on physical indicators. Results: Combined AI and video messaging (treatment group II) led to a lower dropout rate from the program compared to the control group, and the Cox proportional-hazards model estimate showed a hazard ratio (HR) of 0.078, which was statistically significant at the 5% level. Further, human intervention with AI and video messaging significantly reduced the body fat percentage (BFP) of participants after 3 months compared to the control group, and the rate of reduction was greater in the group with more individualized intervention. The AI-based text messages affected the BMI but had no significant effect on the BFP. Conclusions: This experiment shows that it is challenging to sustain participants' healthy behavior with AI intervention alone. The results also suggest that even if the health information conveyed is the same, the information conveyed by humans and AI is more effective in improving health than the information sent by AI alone. The support received from the companion in the form of video messages may have promoted voluntary health behaviors. It is noteworthy that companions were competent, even though they were nonexperts. This means that person-to-person communication is crucial for health interventions. %M 35675107 %R 10.2196/30630 %U https://formative.jmir.org/2022/6/e30630 %U https://doi.org/10.2196/30630 %U http://www.ncbi.nlm.nih.gov/pubmed/35675107 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 6 %P e30065 %T Computerized Psychological Interventions in Veterans and Service Members: Systematic Review of Randomized Controlled Trials %A Pearson,Rahel %A Carl,Emily %A Creech,Suzannah K %+ Veterans Health Administration Veterans Integrated Service Network 17, Center of Excellence for Research on Returning War Veterans, Central Texas Veterans Affairs Healthcare System, 4800 Memorial Drive (151C), Waco, TX, 76711, United States, 1 2542975155, rahel.pearson@va.gov %K computer %K digital %K internet %K interventions %K veterans %K service members %K review %K mobile phone %D 2022 %7 3.6.2022 %9 Review %J J Med Internet Res %G English %X Background: Computerized psychological interventions can overcome logistical and psychosocial barriers to the use of mental health care in the Veterans Affairs and Department of Defense settings. Objective: In this systematic review, we aim to outline the existing literature, with the goal of describing: the scope and quality of the available literature, intervention characteristics, study methods, study efficacy, and study limitations and potential directions for future research. Methods: Systematic searches of two databases (PsycINFO and PubMed) using PRISMA (Preferred Reporting Item for Systematic Reviews and Meta-Analyses) guidelines were conducted from inception until November 15, 2020. The following inclusion criteria were used: the study was published in an English language peer-reviewed journal, participants were randomly allocated to a computerized psychological intervention or a control group (non–computerized psychological intervention active treatment or nonactive control group), an intervention in at least one treatment arm was primarily delivered through the computer or internet with or without additional support, participants were veterans or service members, and the study used validated measures to examine the effect of treatment on psychological outcomes. Results: This review included 23 studies that met the predefined inclusion criteria. Most studies were at a high risk of bias. Targeted outcomes, participant characteristics, type of support delivered, adherence, and participant satisfaction were described. Most of the examined interventions (19/24, 79%) yielded positive results. Study limitations included participant characteristics limiting study inference, high rates of attrition, and an overreliance on self-reported outcomes. Conclusions: Relatively few high-quality studies were identified, and more rigorous investigations are needed. Several recommendations for future research are discussed, including the adoption of methods that minimize attrition, optimize use, and allow for personalization of treatment. %M 35657663 %R 10.2196/30065 %U https://www.jmir.org/2022/6/e30065 %U https://doi.org/10.2196/30065 %U http://www.ncbi.nlm.nih.gov/pubmed/35657663 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 6 %N 1 %P e29926 %T Internet-Based Cognitive Behavioral Therapy and its Association With Self-efficacy, Depressive Symptoms, and Physical Activity: Secondary Analysis of a Randomized Controlled Trial in Patients With Cardiovascular Disease %A Johansson,Peter %A Lundgren,Johan %A Andersson,Gerhard %A Svensson,Erland %A Mourad,Ghassan %+ Department of Health, Medicine and Caring Sciences, Linköping University, Kungsgatan 40, Norrköping, 601 74, Sweden, 46 0700896548, peter.b.johansson@liu.se %K internet-based cognitive behavioral therapy %K cardiovascular disease %K depression %K self-efficacy %K physical activity %K mental health %K depression %K digital health %K online health %K digital therapy %K cognition %K self-care %K CVD %K internet-based %K cardiology %K heart disease %K cardiac health %K cognitive behavioral therapy %D 2022 %7 3.6.2022 %9 Original Paper %J JMIR Cardio %G English %X Background: In patients with cardiovascular disease (CVD), knowledge about the associations among changes in depressive symptoms, self-efficacy, and self-care activities has been requested. This is because such knowledge can be helpful in the design of behavioral interventions aimed to improve self-efficacy, reduce depressive symptoms, and improve performance of self-care activities in CVD patients. Objective: We aim to evaluate if internet-based cognitive behavioral therapy (iCBT) improves self-efficacy and explore the relationships among changes in depressive symptoms, self-efficacy, and physical activity, as well as the influence of iCBT on these relationships. Methods: This study received funding in January 2015. Participant recruitment took place between January 2017 and February 2018, and the main findings were published in 2019. This study is a secondary analysis of data collected in a randomized controlled study evaluating the effects of a 9-week iCBT program compared to an online discussion forum (ODF) on depressive symptoms in patients with CVD (N=144). Data were collected at baseline and at the 9-week follow-up. Analysis of covariance was used to evaluate the differences in self-efficacy between the iCBT and ODF groups. Structural equation modeling explored the relationships among changes in depressive symptoms, self-efficacy, and physical activity, as well as the influence of iCBT on these relationships. Results: At follow-up, a significant difference in the increase in self-efficacy favoring iCBT was found (P=.04, Cohen d=0.27). We found an indirect association between changes in depressive symptoms and physical activity (β=–.24, P<.01), with the change in self-efficacy acting as a mediator. iCBT had a direct effect on the changes in depressive symptoms, which in turn influenced the changes in self-efficacy (β=.23, P<.001) and physical activity (β=.12, P<.001). Conclusions: Self-efficacy was improved by iCBT. However, the influence of iCBT on self-efficacy and physical activity was mostly mediated by improvements in depressive symptoms. Trial Registration: ClinicalTrials.gov NCT02778074; https://clinicaltrials.gov/ct2/show/NCT02778074 %M 35657674 %R 10.2196/29926 %U https://cardio.jmir.org/2022/1/e29926 %U https://doi.org/10.2196/29926 %U http://www.ncbi.nlm.nih.gov/pubmed/35657674 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 6 %P e35947 %T Indicated Web-Based Prevention for Women With Anorexia Nervosa Symptoms: Randomized Controlled Efficacy Trial %A Jacobi,Corinna %A Vollert,Bianka %A Hütter,Kristian %A von Bloh,Paula %A Eiterich,Nadine %A Görlich,Dennis %A Taylor,C Barr %+ Department of Clinical Psychology and Psychotherapy, Faculty of Psychology, Technische Universität Dresden, Chemnitzer Strasse 46, Dresden, 01187, Germany, 49 351 46338576, corinna.jacobi@tu-dresden.de %K anorexia nervosa %K internet %K indicated prevention %D 2022 %7 2.6.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Although preventive interventions for eating disorders in general have shown promise, interventions specifically targeting individuals at risk for anorexia nervosa (AN) are lacking. Objective: The aim of this study was to determine the efficacy of a guided, indicated web-based prevention program for women at risk for AN. Methods: We conducted a randomized controlled efficacy trial for women at risk for AN. Assessments were carried out at baseline (before the intervention), after the intervention (10 weeks after baseline), and at 6- and 12-month follow-ups (FUs). A total of 168 women with low body weight (17.5 kg/m2≤BMI≤19 kg/m2) and high weight concerns or with normal body weight (19 kg/m240% of emergencies. Few apps outperformed laypersons in either deciding whether emergency care was required or whether self-care was sufficient. No apps outperformed the laypersons on both decisions. Conclusions: Triage performance of symptom checkers has, on average, not improved over the course of 5 years. It decreased in 2 use cases (advice on when emergency care is required and when no health care is needed for the moment). However, triage capability varies widely within the sample of symptom checkers. Whether it is beneficial to seek advice from symptom checkers depends on the app chosen and on the specific question to be answered. Future research should develop resources (eg, case vignette repositories) to audit the capabilities of symptom checkers continuously and independently and provide guidance on when and to whom they should be recommended. %M 35536633 %R 10.2196/31810 %U https://www.jmir.org/2022/5/e31810 %U https://doi.org/10.2196/31810 %U http://www.ncbi.nlm.nih.gov/pubmed/35536633 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 5 %N 2 %P e36317 %T Parental Knowledge, Self-confidence, and Usability Evaluation of a Web-Based Infographic for Pediatric Concussion: Multimethod Study %A Campbell,Alyson %A Hartling,Lisa %A Plourde,Vickie %A Scott,Shannon D %+ Faculty of Nursing, University of Alberta, Level 3 Edmonton Clinic Health Academy, 11405 87 Avenue, Edmonton, AB, T6G 1C9, Canada, 1 780 492 1037, shannon.scott@ualberta.ca %K concussion %K mTBI %K usability evaluation %K knowledge assessment %K knowledge translation %K parent knowledge %K parent confidence %K patient engagement %K educational tool %D 2022 %7 10.5.2022 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Concussions, which are known as mild traumatic brain injuries, are complex injuries caused by direct or indirect blows to the head and are increasingly being recognized as a significant public health concern for children and their families. Previous research has identified few studies examining the efficacy of educational interventions on parental concussion knowledge. The aim of this research was to actively work together with children who have experienced a concussion and their parents to develop, refine, and evaluate the usability of a web-based infographic for pediatric concussion. Objective: The objective of this study was to report on the usability of the infographic, parental knowledge, and self-confidence in pediatric concussion knowledge before and after exposure to the infographic. Methods: A multiphase, multimethod research design using patient engagement techniques was used to develop a web-based infographic. For this phase of the research (usability, knowledge, and confidence evaluation), parents who could communicate in English were recruited via social media platforms and invited to complete web-based questionnaires. Electronic preintervention and postintervention questionnaires were administered to parents to assess changes to concussion knowledge and confidence after viewing the infographic. A usability questionnaire with 11 items was also completed. Results: A web-based, infographic was developed. The infographic is intended for parents and children and incorporates information that parents and children identified as both wants and needs about concussion alongside the best available research evidence on pediatric concussion. A total of 31 surveys were completed by parents. The mean scores for each item on the usability surveys ranged from 8.03 (SD 1.70) to 9.26 (SD 1.09) on a 10-point Likert scale, indicating that the usability components of the infographic were largely positive. There was no statistically significant difference between preintervention and postintervention knowledge scores (Z=−0.593; P=.55; both preintervention and postintervention knowledge scores had a median of 9 out of 10). In contrast, there was a statistically significant difference between preintervention (mean 3.9/5, SD 0.56) and postintervention (mean 4.4/5, SD 0.44) confidence in knowledge scores (t30=−5.083; P<.001). Conclusions: Our results demonstrate that parents positively rated a web-based, infographic for pediatric concussion. In addition, although there was no statistically significant difference overall in parents’ knowledge scores before and after viewing the infographic, their confidence in their knowledge did significantly increase. These results suggest that using a web-based infographic as a knowledge translation intervention may be useful in increasing parents’ confidence in managing their child’s concussion. %M 35536631 %R 10.2196/36317 %U https://pediatrics.jmir.org/2022/2/e36317 %U https://doi.org/10.2196/36317 %U http://www.ncbi.nlm.nih.gov/pubmed/35536631 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 2 %P e35065 %T A Mobile App for Prevention of Cardiovascular Disease and Type 2 Diabetes Mellitus: Development and Usability Study %A Buss,Vera Helen %A Varnfield,Marlien %A Harris,Mark %A Barr,Margo %+ Australian e-Health Research Centre, Commonwealth Scientific and Industrial Research Organisation, Level 7, Surgical, Treatment and Rehabilitation Service, 296 Herston Road, Herston, 4029, Australia, 61 732533603, vera.buss@csiro.au %K mobile health %K behavior change intervention %K primary prevention %K health promotion %K cardiovascular disease %K diabetes mellitus, type 2 %K mobile phone %D 2022 %7 10.5.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM) are posing a huge burden on health care systems worldwide. Mobile apps can deliver behavior change interventions for chronic disease prevention on a large scale, but current evidence for their effectiveness is limited. Objective: This paper reported on the development and user testing of a mobile app that aims at increasing risk awareness and engaging users in behavior change. It would form part of an intervention for primary prevention of CVD and T2DM. Methods: The theoretical framework of the app design was based on the Behaviour Change Wheel, combined with the capability, opportunity, and motivation for behavior change system and the behavior change techniques from the Behavior Change Technique Taxonomy (version 1). In addition, evidence from scientific literature has guided the development process. The prototype was tested for user-friendliness via an iterative approach. We conducted semistructured interviews with individuals in the target populations, which included the System Usability Scale. We transcribed and analyzed the interviews using descriptive statistics for the System Usability Scale and thematic analysis to identify app features that improved utility and usability. Results: The target population was Australians aged ≥45 years. The app included 4 core modules (risk score, goal setting, health measures, and education). In these modules, users learned about their risk for CVD and T2DM; set goals for smoking, alcohol consumption, diet, and physical activity; and tracked them. In total, we included 12 behavior change techniques. We conducted 2 rounds of usability testing, each involving 5 participants. The average age of the participants was 58 (SD 8) years. Totally, 60% (6/10) of the participants owned iPhone Operating System phones, and 40% (4/10) of them owned Android phones. In the first round, we identified a technical issue that prevented 30% (3/10) of the participants from completing the registration process. Among the 70% (7/10) of participants who were able to complete the registration process, 71% (5/7) rated the app above average, based on the System Usability Scale. During the interviews, we identified some issues related to functionality, content, and language and clarity. We used the participants’ feedback to improve these aspects. Conclusions: We developed the app using behavior change theory and scientific evidence. The user testing allowed us to identify and remove technical errors and integrate additional functions into the app, which the participants had requested. Next, we will evaluate the feasibility of the revised version of the app developed through this design process and usability testing. %M 35536603 %R 10.2196/35065 %U https://humanfactors.jmir.org/2022/2/e35065 %U https://doi.org/10.2196/35065 %U http://www.ncbi.nlm.nih.gov/pubmed/35536603 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 5 %P e32006 %T Factors Predicting Engagement of Older Adults With a Coach-Supported eHealth Intervention Promoting Lifestyle Change and Associations Between Engagement and Changes in Cardiovascular and Dementia Risk: Secondary Analysis of an 18-Month Multinational Randomized Controlled Trial %A Coley,Nicola %A Andre,Laurine %A Hoevenaar-Blom,Marieke P %A Ngandu,Tiia %A Beishuizen,Cathrien %A Barbera,Mariagnese %A van Wanrooij,Lennard %A Kivipelto,Miia %A Soininen,Hilkka %A van Gool,Willem %A Brayne,Carol %A Moll van Charante,Eric %A Richard,Edo %A Andrieu,Sandrine %A , %A , %+ Center for Epidemiology and Research in Population health (CERPOP), University of Toulouse III Paul Sabatier (UPS), National Institute of Health and Medical Research (INSERM) mixed research unit (UMR) 1295, 37 allées Jules Guesde, Toulouse, 31000, France, 33 561145680, nicola.coley@inserm.fr %K aging %K eHealth %K disparities %K engagement %K prevention %K cardiovascular %K lifestyle %K risk factors %D 2022 %7 9.5.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital health interventions could help to prevent age-related diseases, but little is known about how older adults engage with such interventions, especially in the long term, or whether engagement is associated with changes in clinical, behavioral, or biological outcomes in this population. Disparities in engagement levels with digital health interventions may exist among older people and be associated with health inequalities. Objective: This study aimed to describe older adults’ engagement with an eHealth intervention, identify factors associated with engagement, and examine associations between engagement and changes in cardiovascular and dementia risk factors (blood pressure, cholesterol, BMI, physical activity, diet, and cardiovascular and dementia risk scores). Methods: This was a secondary analysis of the 18-month randomized controlled Healthy Ageing Through Internet Counselling in the Elderly trial of a tailored internet-based intervention encouraging behavior changes, with remote support from a lifestyle coach, to reduce cardiovascular and cognitive decline risk in 2724 individuals aged ≥65 years, recruited offline in the Netherlands, Finland, and France. Engagement was assessed via log-in frequency, number of lifestyle goals set, measurements entered and messages sent to coaches, and percentage of education materials read. Clinical and biological data were collected during in-person visits at baseline and 18 months. Lifestyle data were self-reported on a web-based platform. Results: Of the 1389 intervention group participants, 1194 (85.96%) sent at least one message. They logged in a median of 29 times, and set a median of 1 goal. Higher engagement was associated with significantly greater improvement in biological and behavioral risk factors, with evidence of a dose-response effect. Compared with the control group, the adjusted mean difference (95% CI) in 18-month change in the primary outcome, a composite z-score comprising blood pressure, BMI, and cholesterol, was −0.08 (−0.12 to −0.03), −0.04 (−0.08 to 0.00), and 0.00 (−0.08 to 0.08) in the high, moderate, and low engagement groups, respectively. Low engagers showed no improvement in any outcome measures compared with the control group. Participants not using a computer regularly before the study engaged much less with the intervention than those using a computer up to 7 (adjusted odds ratio 5.39, 95% CI 2.66-10.95) or ≥7 hours per week (adjusted odds ratio 6.58, 95% CI 3.21-13.49). Those already working on or with short-term plans for lifestyle improvement at baseline, and with better cognition, engaged more. Conclusions: Greater engagement with an eHealth lifestyle intervention was associated with greater improvement in risk factors in older adults. However, those with limited computer experience, who tended to have a lower level of education, or who had poorer cognition engaged less. Additional support or forms of intervention delivery for such individuals could help minimize potential health inequalities associated with the use of digital health interventions in older people. %M 35385395 %R 10.2196/32006 %U https://www.jmir.org/2022/5/e32006 %U https://doi.org/10.2196/32006 %U http://www.ncbi.nlm.nih.gov/pubmed/35385395 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 5 %P e27707 %T The Role of Emotion Regulation and Loss-Related Coping Self-efficacy in an Internet Intervention for Grief: Mediation Analysis %A Brodbeck,Jeannette %A Berger,Thomas %A Biesold,Nicola %A Rockstroh,Franziska %A Schmidt,Stefanie J %A Znoj,Hansjoerg %+ Department of Clinical Psychology and Psychotherapy, University of Bern, Fabrikstrasse 8, Bern, 3012, Switzerland, 41 316843805, jeannette.brodbeck@unibe.ch %K grief %K divorce %K separation %K bereavement %K internet intervention %K emotion regulation %K coping self-efficacy %K mediation %D 2022 %7 6.5.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Internet interventions for mental disorders and psychological problems such as prolonged grief have established their efficacy. However, little is known about how internet interventions work and the mechanisms through which they are linked to the outcomes. Objective: As a first step in identifying mechanisms of change, this study aimed to examine emotion regulation and loss-related coping self-efficacy as putative mediators in a randomized controlled trial of a guided internet intervention for prolonged grief symptoms after spousal bereavement or separation or divorce. Methods: The sample comprised older adults who reported prolonged grief or adaptation problems after bereavement, separation, or divorce and sought help from a guided internet intervention. They were recruited mainly via newspaper articles. The outcome variables were grief symptoms assessed using the Texas Revised Inventory of Grief and psychopathology symptoms assessed using the Brief Symptom Inventory. A total of 6 module-related items assessed loss-focused emotion regulation and loss-related coping self-efficacy. In the first step, path models were used to examine emotion regulation and loss-related coping self-efficacy as single mediators for improvements in grief and psychopathology symptoms. Subsequently, exploratory path models with the simultaneous inclusion of emotion regulation and self-efficacy were used to investigate the specificity and relative strength of these variables as parallel mediators. Results: A total of 100 participants took part in the guided internet intervention. The average age was 51.11 (SD 13.60) years; 80% (80/100) were separated or divorced, 69% (69/100) were female, and 76% (76/100) were of Swiss origin. The internet intervention increased emotion regulation skills (β=.33; P=.001) and loss-related coping self-efficacy (β=.30; P=.002), both of which correlated with improvements in grief and psychopathology symptoms. Path models suggested that emotion regulation and loss-related coping self-efficacy were mediators for improvement in grief. Emotion regulation showed a significant indirect effect (β=.13; P=.009), whereas coping self-efficacy showed a trend (β=.07; P=.06). Both were confirmed as mediators for psychopathology (β=.12, P=.02; β=.10; P=.02, respectively). The path from the intervention to the improvement in grief remained significant when including the mediators (β=.26, P=.004; β=.32, P≤.001, respectively) in contrast to the path from the intervention to improvements in psychopathology (β=.15, P=.13; β=.16, P=.10, respectively). Conclusions: Emotion regulation and loss-related coping self-efficacy are promising therapeutic targets for optimizing internet interventions for grief. Both should be further examined as transdiagnostic or disorder-specific putative mediators in internet interventions for other disorders. Trial Registration: ClinicalTrials.gov NCT02900534; https://clinicaltrials.gov/ct2/show/NCT02900534 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-016-1759-5 %M 35522459 %R 10.2196/27707 %U https://mental.jmir.org/2022/5/e27707 %U https://doi.org/10.2196/27707 %U http://www.ncbi.nlm.nih.gov/pubmed/35522459 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 5 %P e33505 %T Health Care Professionals’ Experiences of Web-Based Symptom Checkers for Triage: Cross-sectional Survey Study %A Kujala,Sari %A Hörhammer,Iiris %+ Department of Computer Science, Aalto University, PO Box 15400, Espoo, FI-00076, Finland, 358 503862768, sari.kujala@aalto.fi %K adoption %K symptom checker %K triage %K health care professional %K survey %K online health %K digital health %K health organizations %K health care %D 2022 %7 5.5.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based symptom checkers are promising tools that provide help to patients seeking guidance on health problems. Many health organizations have started using them to enhance triage. Patients use the symptom checker to report their symptoms online and submit the report to the health care center through the system. Health care professionals (registered nurse, practical nurse, general physician, physiotherapist, etc) receive patient inquiries with urgency rating, decide on actions to be taken, and communicate these to the patients. The success of the adoption, however, depends on whether the tools can efficiently support health care professionals’ workflow and achieve their support. Objective: This study explores the factors influencing health care professionals’ support for a web-based symptom checker for triage. Methods: Data were collected through a web-based survey of 639 health care professionals using either of the two most used web-based symptom checkers in the Finnish public primary care. Linear regression models were fitted to study the associations between the study variables and health care professionals’ support for the symptom checkers. In addition, the health care professionals’ comments collected via survey were qualitatively analyzed to elicit additional insights about the benefits and challenges of the clinical use of symptom checkers. Results: Results show that the perceived beneficial influence of the symptom checkers on health care professionals’ work and the perceived usability of the tools were positively associated with professionals’ support. The perceived benefits to patients and organizational support for use were positively associated, and threat to professionals’ autonomy was negatively associated with health care professionals’ support. These associations were, however, not independent of other factors included in the models. The influences on professionals’ work were both positive and negative; the tools streamlined work by providing preliminary information on patients and reduced the number of phone calls, but they also created extra work as the professionals needed to call patients and ask clarifying questions. Managing time between the use of symptom checkers and other tasks was also challenging. Meanwhile, according to health care professionals’ experience, the symptom checkers benefited patients as they received help quickly with a lower threshold for care. Conclusions: The efficient use of symptom checkers for triage requires usable solutions that support health care professionals’ work. High-quality information about the patients’ conditions and an efficient way of communicating with patients are needed. Using a new eHealth tool also requires that health organizations and teams reorganize their workflows and work distributions to support clinical processes. %M 35511254 %R 10.2196/33505 %U https://www.jmir.org/2022/5/e33505 %U https://doi.org/10.2196/33505 %U http://www.ncbi.nlm.nih.gov/pubmed/35511254 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 5 %P e37292 %T A Group-Facilitated, Internet-Based Intervention to Promote Mental Health and Well-Being in a Vulnerable Population of University Students: Randomized Controlled Trial of the Be Well Plan Program %A Fassnacht,Daniel B %A Ali,Kathina %A van Agteren,Joep %A Iasiello,Matthew %A Mavrangelos,Teri %A Furber,Gareth %A Kyrios,Michael %+ College of Education, Psychology and Social Work, Flinders University, Sturt Road, Bedford Park, Adelaide, 5042, Australia, 61 8 8201 2621, dan.fassnacht@flinders.edu.au %K COVID-19 %K mental health %K well-being %K depression %K anxiety %K online %K digital %K intervention %K Be Well Plan %K health outcome %K online health %K digital health %K health intervention %K primary outcome %K cognition %K randomized control trial %K resilience %K participant satisfaction %K student %D 2022 %7 5.5.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: A growing literature supports the use of internet-based interventions to improve mental health outcomes. However, most programs target specific symptoms or participant groups and are not tailored to facilitate improvements in mental health and well-being or do not allow for needs and preferences of individual participants. The Be Well Plan, a 5-week group-facilitated, internet-based mental health and well-being group intervention addresses these gaps, allowing participants to select a range of activities that they can tailor to their specific characteristics, needs, and preferences. Objective: This study aims to test whether the Be Well Plan program was effective in improving primary outcomes of mental well-being, resilience, anxiety, and depression compared to a waitlist control group during the COVID-19 pandemic; secondary outcomes included self-efficacy, a sense of control, and cognitive flexibility. The study further seeks to examine participants’ engagement and satisfaction with the program. Methods: A randomized controlled trial (RCT) was conducted with 2 parallel arms, an intervention and a waitlist control group. The intervention involved 5 weekly 2-hour sessions, which were facilitated in group format using Zoom videoconferencing software. University students were recruited via social media posts, lectures, emails, flyers, and posters. Results: Using an intentional randomization 2:1 allocation strategy, we recruited 215 participants to the trial (n=126, 58.6%, intervention group; n=89, 41.4%, waitlist control group). Of the 126 participants assigned to the intervention group, 75 (59.5%) commenced the program and were included in modified intention-to-treat (mITT) analyses. mITT intervention participants attended, on average, 3.41 sessions (SD 1.56, median 4); 55 (73.3%) attended at least 4 sessions, and 25 (33.3%) attended all 5 sessions. Of the 49 intervention group participants who completed the postintervention assessment, 47 (95.9%) were either very satisfied (n=31, 66%) or satisfied (n=16, 34%). The mITT analysis for well-being (F1,162=9.65, P=.002, Cohen d=0.48) and resilience (F1,162=7.85, P=.006, Cohen d=0.44) showed significant time × group interaction effects, suggesting that both groups improved over time, but the Be Well Plan (intervention) group showed significantly greater improvement compared to the waitlist control group. A similar pattern of results was observed for depression and anxiety (Cohen d=0.32 and 0.37, respectively), as well as the secondary outcomes (self-efficacy, Cohen d=0.50; sense of control, Cohen d=0.42; cognitive flexibility, Cohen d=0.65). Larger effect sizes were observed in the completer analyses. Reliable change analysis showed that the majority of mITT participants (58/75, 77.3%) demonstrated a significant reliable improvement in at least 1 of the primary outcomes. Conclusions: The Be Well Plan program was effective in improving mental health and well-being, including mental well-being, resilience, depression, and anxiety. Participant satisfaction scores and attendance indicated a high degree of engagement and satisfaction with the program. Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12621000180819; https://tinyurl.com/2p8da5sk %M 35471196 %R 10.2196/37292 %U https://mental.jmir.org/2022/5/e37292 %U https://doi.org/10.2196/37292 %U http://www.ncbi.nlm.nih.gov/pubmed/35471196 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 5 %P e27277 %T A Multifaceted Intervention to Improve Medication Adherence in Kidney Transplant Recipients: An Exploratory Analysis of the Fidelity of the TAKE IT Trial %A Yoon,Esther S %A Hur,Scott %A Curtis,Laura M %A Wynia,Aiden H %A Zheng,Pauline %A Nair,Sumi S %A Bailey,Stacy C %A Serper,Marina %A Reese,Peter P %A Ladner,Daniela P %A Wolf,Michael S %+ Center for Applied Health Research on Aging, Feinberg School of Medicine, Northwestern University, 750 N. Lake Shore Drive, Chicago, IL, 60611, United States, 1 3125034948, esther.yoon@northwestern.edu %K kidney transplantation %K medication adherence %K fidelity %K digital health %K patient portal %D 2022 %7 5.5.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Inadequate adherence to prescribed immunosuppressive medication regimens among kidney transplant recipients is common, yet interventions are needed to support patients in sustaining adequate adherence to prescribed regimens and achieving optimal transplant outcomes. Objective: We examined the preliminary fidelity of a transplant center-based, multifaceted adherence monitoring strategy known as TAKE IT. Methods: The TAKE IT strategy includes: (1) routine, online, monthly patient self-report adherence assessments; (2) care alerts directed to nurses; (3) quarterly reports monitoring tacrolimus values and adherence trends; (4) support tools tailored to specific adherence concerns. A 2-arm, patient-randomized trial is underway at two large transplant centers (N=449). To evaluate the initial fidelity of TAKE IT, we investigated patient uptake of monthly adherence assessments during the course of a 3-month period, whether any disparities emerged, and the nature of any reported adherence concerns. Results: Among 202 patients randomized and exposed to TAKE IT for 3-months or more, 81% (164/202) completed an adherence assessment, 73% (148/202) completed at least two, and 57% (116/202) completed all monthly assessments. Overall, 50% (82/164) of kidney transplant recipients reported at least one adherence concern over the 3-month assessment period. The most common barriers were classified as regimen-related (eg, regimen complexity), cognitive (eg, forgetfulness), and medical (eg, side effects). Higher-income participants were more likely to complete all surveys compared to lower-income participants (P=.01). Conclusions: TAKE IT demonstrated 81% (164/202) completion of an adherence assessment, 73% (148/202) completion of at least two, and 57% (116/202) completion of all monthly assessments during this brief, initial observation period. Among those that did respond to the online assessments, the majority demonstrated sustained engagement. Additional monitoring modalities could also be offered to meet patient preferences to ensure all patients’ medication use can be properly monitored. Trial Registration: ClinicalTrials.gov NCT03104868; https://clinicaltrials.gov/ct2/show/NCT03104868 %M 35511225 %R 10.2196/27277 %U https://formative.jmir.org/2022/5/e27277 %U https://doi.org/10.2196/27277 %U http://www.ncbi.nlm.nih.gov/pubmed/35511225 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 5 %P e30073 %T Delivering Mindfulness-Based Interventions for Insomnia, Pain, and Dysfunctional Eating Through a Text Messaging App: Three Randomized Controlled Trials Investigating the Effectiveness and Mediating Mechanisms %A Li,Amanda CM %A Wong,Keith KL %A Chio,Floria HN %A Mak,Winnie WS %A Poon,Loretta WH %+ Department of Psychology, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, Hong Kong, 852 39436577, wwsmak@psy.cuhk.edu.hk %K text messaging %K mindfulness %K insomnia %K pain %K dysregulated eating %K mHealth %K mental health %K SMS %K distress %K intervention %K outcome %K mobile interventions %D 2022 %7 3.5.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Although text messaging has the potential to be the core intervention modality, it is often used as an adjunct only. To improve health and alleviate the distress related to insomnia, pain, and dysregulated eating of people living in urban areas, text messaging–based mindfulness-based interventions were designed and evaluated in 3 randomized controlled trials. Objective: This study investigated the effectiveness and mediating mechanisms of text messaging–based mindfulness-based interventions for people with distress related to insomnia, pain, or dysregulated eating. Methods: In these trials, 333, 235, and 351 participants were recruited online and randomized to intervention and wait-list control conditions for insomnia, pain, and dysregulated eating, respectively. Participants experienced 21 days of intervention through WhatsApp Messenger. Participants completed pre-, post-, 1-month follow-up, and 3-month follow-up self-report questionnaires online. The retention rates at postmeasurements were 83.2% (139/167), 77.1% (91/118), and 72.9% (129/177) for intervention groups of insomnia, pain, and dysregulated eating, respectively. Participants’ queries were answered by a study technician. Primary outcomes included insomnia severity, presleep arousal, pain intensity, pain acceptance, and eating behaviors. Secondary outcomes included mindfulness, depression, anxiety, mental well-being, and functional impairments. Mindfulness, dysfunctional beliefs and attitudes about sleep, pain catastrophizing, and reactivity to food cues were hypothesized to mediate the relationship between the intervention and outcomes. Results: For all 3 studies, the intervention groups showed significant improvement on most outcomes at 1-month follow-up compared to their respective wait-list control groups; some primary outcomes (eg, insomnia, pain, dysregulated eating indicators) and secondary outcomes (eg, depression, anxiety symptoms) were sustained at 3-month follow-up. Medium-to-large effect sizes were found at postassessments in most outcomes in all studies. In the intervention for insomnia, mediation analyses showed that dysfunctional beliefs and attitudes about sleep mediated the effect of the intervention on all primary outcomes and most secondary outcomes at both 1-month and 3-month follow-ups, whereas mindfulness mediated the intervention effect on presleep arousal at 1-month and 3-month follow-ups. In the intervention for pain, pain catastrophizing mediated the effect of intervention on pain intensity and functioning at both 1-month and 3-month follow-ups, whereas mindfulness only mediated the effect of intervention on anxiety and depressive symptoms. In the intervention for dysregulated eating, power of food mediated the effect of intervention on both uncontrolled and emotional eating at both 1-month and 3-month follow-ups and mindfulness was found to mediate the effect on depressive symptoms at both 1-month and 3-month follow-ups. Conclusions: These 3 studies converged and provided empirical evidence that mindfulness-based interventions delivered through text messaging are effective in improving distress related to sleep, pain, and dysregulated eating. Text messaging has the potential to be a core intervention modality to improve various common health outcomes for people living a fast-paced lifestyle. Trial Registration: Clinical Research and Biostatistics Clinical Trials Registry CUHK_CCRB00559; https://tinyurl.com/24rkwarz %M 35503653 %R 10.2196/30073 %U https://www.jmir.org/2022/5/e30073 %U https://doi.org/10.2196/30073 %U http://www.ncbi.nlm.nih.gov/pubmed/35503653 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 5 %N 2 %P e35847 %T Delivering Personalized Recommendations to Support Caregivers of People Living With Dementia: Mixed Methods Study %A Cha,Jinhee %A Peterson,Colleen M %A Millenbah,Ashley N %A Louwagie,Katie %A Baker,Zachary G %A Shah,Ayush %A Jensen,Christine J %A Gaugler,Joseph E %+ Medical School and School of Public Health, University of Minnesota, 420 Delaware St SE, Minneapolis, MN, 55455, United States, 1 6513523161, cha00003@umn.edu %K caregivers %K caregiving %K Alzheimer %K dementia %K intervention %K COVID-19 %D 2022 %7 3.5.2022 %9 Original Paper %J JMIR Aging %G English %X Background: Estimates suggest that 6.2 million Americans aged ≥65 years are living with Alzheimer dementia in 2021, and by 2060, this number could more than double to 13.8 million. As a result, public health officials anticipate a greater need for caregivers of persons with Alzheimer disease or related dementia and support resources for both people living with dementia and their caregivers. Despite the growing need for dementia caregiver support services, there is a lack of consensus regarding how to tailor these services to best meet the heterogeneous needs of individual caregivers. To fill this gap, Care to Plan (CtP), a web-based tool for caregivers of people living with dementia, was developed to provide tailored support recommendations to dementia caregivers. Objective: The aim of this study is to formally explore the feasibility, acceptability, and utility of CtP for 20 family members of people living with dementia within a health system over a 1-month time period using a mixed methods parallel convergent design. Methods: A moderately sized health system in the mid-Atlantic region was selected as the site for CtP implementation, where 20 caregivers who were family members of people living with dementia were enrolled. The web-based CtP tool was used by caregivers and facilitated by a health care professional (ie, a senior care navigator [SCN]). Caregivers were given a 21-item review checklist to assess barriers and facilitators associated with reviewing CtP with an SCN. Following the 21-item review checklist, semistructured telephone interviews, which included 18 open-ended questions, focused on the facilitators of and barriers to CtP implementation and recommendations for future implementation. Results: Quantitative results suggested that 85% (17/20) of caregivers indicated that CtP was helpful and 90% (18/20) would recommend CtP to someone in a similar situation. The qualitative analysis identified 4 themes regarding facilitators of and barriers to implementation: caregiver factors, SCN factors, CtP tool system factors, and recommendations and resources factors. Conclusions: CtP was found to be not only feasible but also a valuable tool for caregivers seeking resources for themselves and their people living with dementia. Long-term evaluation findings aim to generate results on how CtP can be integrated into care plans for caregivers and how SCNs can provide additional support for caregivers of people living with dementia over an extended period. %M 35503650 %R 10.2196/35847 %U https://aging.jmir.org/2022/2/e35847 %U https://doi.org/10.2196/35847 %U http://www.ncbi.nlm.nih.gov/pubmed/35503650 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 5 %P e36775 %T Therapeutic Alliance in Online and Face-to-face Psychological Treatment: Comparative Study %A Mercadal Rotger,Josep %A Cabré,Victor %+ Institut Universitari de Salut Mental Vidal i Barraquer, Universitat Ramon Llull, C/ Sant Gervasi de Cassoles 88-90, Barcelona, 08022, Spain, 34 660221557, jmercadal@fvb.cat %K online psychological intervention %K therapeutic alliance %K digital health %K mental health %K mental health education %K mental health treatment %K health interventions %K health professional %K online health %K web-based health %K intervention modality %D 2022 %7 2.5.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Since the COVID-19 pandemic, the number of online mental health treatments have grown exponentially. Additionally, it seems inevitable that this technical resource is here to stay at health centers. However, there is still very little scholarly literature published on this topic, and therefore, the impact of the changes that have had to be dealt with in this regard has not been studied. Objective: This study aims to evaluate the differences in the establishment of the therapeutic alliance (TA) based on the intervention modality (online or face-to-face), the type of attachment, and diagnosis. Methods: A total of 291 subjects participated in the study, 149 (51.2%) of whom were men and 142 were (48.8%) women between the ages of 18 and 30 years. The instruments used were sociodemographic data, SOFTA-o (System for Observing Family Therapeutic Alliances—observational), and Relationship Questionnaire. Results: The results show that the treatments conducted face-to-face obtain significantly better scores in the creation of the TA than those conducted online (t=–42.045, df=289, P<.001). The same holds true with attachment, in that users with secure attachment show a better TA than those with insecure attachment (t=6.068, P<.001,), although there were no significant differences with the diagnosis (F=4.566, P=.44), age (r=0.02, P=.70), and sex (t=0.217, P=.33). Conclusions: We believe that professionals are not yet prepared to conduct remote treatment with a degree of efficacy similar to that of face-to-face. It is essential for professionals to receive training in this new technical resource and to understand and incorporate the variants it entails into their daily practice. %M 35499910 %R 10.2196/36775 %U https://mental.jmir.org/2022/5/e36775 %U https://doi.org/10.2196/36775 %U http://www.ncbi.nlm.nih.gov/pubmed/35499910 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 5 %P e35048 %T Engagement, Predictors, and Outcomes of a Trauma Recovery Digital Mental Health Intervention: Longitudinal Study %A Yeager,Carolyn M %A Benight,Charles C %+ Lyda Hill Institute for Human Resilience, University of Colorado Colorado Springs, Fourth Floor, 4863 North Nevada Avenue, Colorado Springs, CO, 80918, United States, 1 (719) 413 8075, cyeager@uccs.edu %K engagement %K digital health %K digital mental health intervention %K social cognitive theory %K SCT %K self-efficacy %K outcome expectations %K trauma %K posttraumatic stress disorder %K PTSD %D 2022 %7 2.5.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Worldwide, exposure to potentially traumatic events is extremely common, and many individuals develop posttraumatic stress disorder (PTSD) along with other disorders. Unfortunately, considerable barriers to treatment exist. A promising approach to overcoming treatment barriers is a digital mental health intervention (DMHI). However, engagement with DMHIs is a concern, and theoretically based research in this area is sparse and often inconclusive. Objective: The focus of this study is on the complex issue of DMHI engagement. On the basis of the social cognitive theory framework, the conceptualization of engagement and a theoretically based model of predictors and outcomes were investigated using a DMHI for trauma recovery. Methods: A 6-week longitudinal study with a national sample of survivors of trauma was conducted to measure engagement, predictors of engagement, and mediational pathways to symptom reduction while using a trauma recovery DMHI (time 1: N=915; time 2: N=350; time 3: N=168; and time 4: N=101). Results: Confirmatory factor analysis of the engagement latent constructs of duration, frequency, interest, attention, and affect produced an acceptable model fit (χ22=8.3; P=.02; comparative fit index 0.973; root mean square error of approximation 0.059; 90% CI 0.022-0.103). Using the latent construct, the longitudinal theoretical model demonstrated adequate model fit (comparative fit index 0.929; root mean square error of approximation 0.052; 90% CI 0.040-0.064), indicating that engagement self-efficacy (β=.35; P<.001) and outcome expectations (β=.37; P<.001) were significant predictors of engagement (R2=39%). The overall indirect effect between engagement and PTSD symptom reduction was significant (β=–.065; P<.001; 90% CI –0.071 to –0.058). This relationship was serially mediated by both skill activation self-efficacy (β=.80; P<.001) and trauma coping self-efficacy (β=.40; P<.001), which predicted a reduction in PTSD symptoms (β=−.20; P=.02). Conclusions: The results of this study may provide a solid foundation for formalizing the nascent science of engagement. Engagement conceptualization comprised general measures of attention, interest, affect, and use that could be applied to other applications. The longitudinal research model supported 2 theoretically based predictors of engagement: engagement self-efficacy and outcome expectancies. A total of 2 task-specific self-efficacies—skill activation and trauma coping—proved to be significant mediators between engagement and symptom reduction. Taken together, this model can be applied to other DMHIs to understand engagement, as well as predictors and mechanisms of action. Ultimately, this could help improve the design and development of engaging and effective trauma recovery DMHIs. %M 35499857 %R 10.2196/35048 %U https://mental.jmir.org/2022/5/e35048 %U https://doi.org/10.2196/35048 %U http://www.ncbi.nlm.nih.gov/pubmed/35499857 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e29258 %T Internet-Delivered Cognitive Behavioral Therapy for Insomnia Comorbid With Chronic Pain: Randomized Controlled Trial %A Wiklund,Tobias %A Molander,Peter %A Lindner,Philip %A Andersson,Gerhard %A Gerdle,Björn %A Dragioti,Elena %+ Pain and Rehabilitation Centre, and Department of Health, Medicine and Caring Sciences, Linköping University, Brigadgatan 22, Linkoping, 581 85, Sweden, 46 763251361, elena.dragioti@liu.se %K insomnia %K chronic pain %K comorbid %K CBT-i %K RCT %K web-based CBT %K pain %K online health %K online treatment %K digital health %K mental health %K rehabilitation %D 2022 %7 29.4.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Patients with chronic pain often experience insomnia symptoms. Pain initiates, maintains, and exacerbates insomnia symptoms, and vice versa, indicating a complex situation with an additional burden for these patients. Hence, the evaluation of insomnia-related interventions for patients with chronic pain is important. Objective: This randomized controlled trial examined the effectiveness of internet-based cognitive behavioral therapy for insomnia (ICBT-i) for reducing insomnia severity and other sleep- and pain-related parameters in patients with chronic pain. Participants were recruited from the Swedish Quality Registry for Pain Rehabilitation. Methods: We included 54 patients (mean age 49.3, SD 12.3 years) who were randomly assigned to the ICBT-i condition and 24 to an active control condition (applied relaxation). Both treatment conditions were delivered via the internet. The Insomnia Severity Index (ISI), a sleep diary, and a battery of anxiety, depression, and pain-related parameter measurements were assessed at baseline, after treatment, and at a 6-month follow-up (only ISI, anxiety, depression, and pain-related parameters). For the ISI and sleep diary, we also recorded weekly measurements during the 5-week treatment. Negative effects were also monitored and reported. Results: Results showed a significant immediate interaction effect (time by treatment) on the ISI and other sleep parameters, namely, sleep efficiency, sleep onset latency, early morning awakenings, and wake time after sleep onset. Participants in the applied relaxation group reported no significant immediate improvements, but both groups exhibited a time effect for anxiety and depression at the 6-month follow-up. No significant improvements on pain-related parameters were found. At the 6-month follow-up, both the ICBT-i and applied relaxation groups had similar sleep parameters. For both treatment arms, increased stress was the most frequently reported negative effect. Conclusions: In patients with chronic pain, brief ICBT-i leads to a more rapid decline in insomnia symptoms than does applied relaxation. As these results are unique, further research is needed to investigate the effect of ICBT-i on a larger sample size of people with chronic pain. Using both treatments might lead to an even better outcome in patients with comorbid insomnia and chronic pain. Trial Registration: ClinicalTrials.gov NCT03425942; https://clinicaltrials.gov/ct2/show/NCT03425942 %M 35486418 %R 10.2196/29258 %U https://www.jmir.org/2022/4/e29258 %U https://doi.org/10.2196/29258 %U http://www.ncbi.nlm.nih.gov/pubmed/35486418 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 8 %N 2 %P e31815 %T The Acceptability of an Electronically Delivered Acceptance- and Mindfulness-Based Physical Activity Intervention for Survivors of Breast Cancer: One-Group Pretest-Posttest Design %A Robertson,Michael C %A Cox-Martin,Emily %A Shegog,Ross %A Markham,Christine M %A Fujimoto,Kayo %A Durand,Casey P %A Brewster,Abenaa %A Lyons,Elizabeth J %A Liao,Yue %A Flores,Sara A %A Basen-Engquist,Karen M %+ Department of Nutrition, Metabolism, and Rehabilitation Sciences, The University of Texas Medical Branch, 301 University Blvd, Galveston, TX, 77555, United States, 1 409 772 3030, mcrobert@utmb.edu %K cancer survivors %K exercise %K mindfulness %K Acceptance and Commitment Therapy %K behavioral sciences %D 2022 %7 29.4.2022 %9 Original Paper %J JMIR Cancer %G English %X Background: Survivors of breast cancer can face internal barriers to physical activity, such as uncertainty and frustration stemming from physical limitations, decreased physical functioning, fatigue, and pain. Interventions that draw from the principles of Acceptance and Commitment Therapy (ACT) may help survivors of breast cancer overcome some of the internal barriers associated with physical activity. Objective: The primary aim of this study was to investigate the acceptability of an electronically delivered physical activity intervention for survivors of breast cancer, centered on ACT processes. Methods: This study used a 1-group pretest-posttest design. We recruited 80 insufficiently active female survivors of breast cancer using a web-based recruitment strategy. The 8-week intervention consisted of weekly modules that featured didactic lessons and experiential exercises targeting key ACT processes in the context of physical activity promotion (namely, values, committed action, acceptance, defusion, and contacting the present moment). We determined intervention acceptability according to study retention (≥70%), adherence rates (≥75% of the participants completing ≥50% of the modules), and posttest survey scores reflecting the perceived ease of use, perceived usefulness, and interest and enjoyment of the intervention (≥5 on a 7-point Likert-type scale). We also evaluated changes in self-reported aerobic and muscle strengthening–physical activity, physical activity acceptance, physical activity regulation, and health-related outcomes. Results: The retention rate (61/80, 76%), adherence rate (60/80, 75%), average perceived ease of use (6.17, SD 1.17), perceived usefulness (5.59, SD 1.40), and interest and enjoyment scores (5.43, SD 1.40) met the acceptability criteria. Participants increased their self-reported aerobic physical activity (Cohen d=1.04), muscle strengthening–physical activity (Cohen d=1.02), physical activity acceptance (cognitive acceptance: Cohen d=0.35; behavioral commitment: Cohen d=0.51), physical activity regulation (identified regulation: Cohen d=0.37; integrated regulation: Cohen d=0.66), increased their ability to participate in social roles and activities (Cohen d=0.18), and reported less fatigue (Cohen d=0.33) and sleep disturbance (Cohen d=0.53). Conclusions: Electronically delivered acceptance- and mindfulness-based interventions may be useful for promoting physical activity in survivors of breast cancer. Further research is needed to refine these approaches and evaluate their effectiveness. %M 35486425 %R 10.2196/31815 %U https://cancer.jmir.org/2022/2/e31815 %U https://doi.org/10.2196/31815 %U http://www.ncbi.nlm.nih.gov/pubmed/35486425 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 8 %N 2 %P e29292 %T Communicating Treatment-Related Symptoms Using Passively Collected Data and Satisfaction/Loyalty Ratings: Exploratory Study %A Kudel,Ian %A Perry,Toni %+ Varian, a Siemens Healthineers Company, 3100 Hansen Way, Palo Alto, CA, 94304, United States, 1 518 902 8554, ian.kudel@varian.com %K electronic patient-reported outcomes %K ePRO %K cancer %K symptoms %K health-related quality of life %D 2022 %7 29.4.2022 %9 Original Paper %J JMIR Cancer %G English %X Background: Electronic patient-reported outcomes’ real time communication of treatment-related symptoms is increasingly associated with better outcomes including longer survival and less health care resource use, but the primary method of collecting this information, static questionnaires, has not evolved. Objective: The aim of this paper is to describe the use of Noona’s three methods of communicating treatment-related symptoms, which are as follows: (1) Noona symptom questionnaires (NSQ), which incorporate branching logic; (2) a diary; and (3) secure messaging, the last two of which have NSQ reporting functionality. It also aims to explore, using multivariable analyses, whether patients find value using these features. Methods: Noona users (N=1081) who have an active account for more than 30 days, who responded to the satisfaction/loyalty item, and who were undergoing active cancer treatment (systemic or radiotherapy) in the United States were included in this study. All study data were collected via software embedded within Noona code. This includes metadata, patient activities (measured in clicks), and responses to a satisfaction/loyalty question (“How likely are you to recommend Noona to another patient”) displayed on the Noona home page. Results: Noona users expressed a high degree of satisfaction/loyalty when asked to rate how likely they would recommend Noona to another patient. Multivariable analyses indicate small but significant effects for some of the analyses. Use of NSQs were significantly related to satisfaction/loyalty, users of NSQs had significantly higher satisfaction/loyalty than those who did not use any, and secure communication use was significantly higher for those who rated the app highly compared to those who did not. These relationships will likely be further explicated with the use of satisfaction/loyalty questions that focus specifically on feature use. Conclusions: Noona is well liked by respondents, and exploratory multivariable analyses demonstrate the potential for using passively and minimally invasive data to demonstrate value. %M 35175206 %R 10.2196/29292 %U https://cancer.jmir.org/2022/2/e29292 %U https://doi.org/10.2196/29292 %U http://www.ncbi.nlm.nih.gov/pubmed/35175206 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e30058 %T Effects of Using a Text Message Intervention on Psychological Constructs and the Association Between Changes to Psychological Constructs and Medication Adherence in People With Type 2 Diabetes: Results From a Randomized Controlled Feasibility Study %A Bartlett,Yvonne Kiera %A Farmer,Andrew %A Newhouse,Nikki %A Miles,Lisa %A Kenning,Cassandra %A French,David P %+ Manchester Centre for Health Psychology, School of Health Sciences, University of Manchester, Coupland 1 Building, Oxford Road, Manchester, M13 9PL, United Kingdom, 44 161 3065436, kiera.bartlett.uom@gmail.com %K medication adherence %K type 2 diabetes mellitus %K behavior change techniques %K text messaging %K feasibility studies %K diabetes %K medication %K digital health %D 2022 %7 29.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Poor adherence to oral medications is common in people with type 2 diabetes and can lead to an increased chance of health complications. Text messages may provide an effective delivery method for an intervention; however, thus far, the majority of these interventions do not specify either a theoretical basis or propose specific mechanisms of action. This makes it hard to determine how and whether an intervention is having an effect. The text messages included in the current intervention have been developed to deliver specific behavior change techniques. These techniques are the “active ingredients” of the intervention and were selected to target psychological constructs identified as predictors of medication adherence. Objective: There are 2 aims of this study: (1) to assess whether a text message intervention with specified behavior change techniques can change the constructs that predict medication adherence behaviors in people with type 2 diabetes and (2) to assess whether changes to psychological constructs are associated with changes in self-reported medication adherence. Methods: We conducted a randomized controlled, 6-month feasibility trial. Adults prescribed oral medication for type 2 diabetes (N=209) were recruited from general practice and randomized to either receive a text message–based intervention or care as usual. Data were analyzed with repeated measures analysis of covariance and Spearman rho correlation coefficients. Results: For 8 of the 14 constructs that were measured, a significant time-by-condition interaction was found: necessity beliefs, intention, maintenance self-efficacy, recovery self-efficacy, action control, prompts and cues, social support, and satisfaction with experienced consequences all increased in the intervention group compared to the control group. Changes in action self-efficacy, intention, automaticity, maintenance self-efficacy, and satisfaction with experienced consequences were positively associated with changes in self-reported medication adherence. Conclusions: A relatively low-cost, scalable, text message–only intervention targeting medication adherence using behavior change techniques can influence psychological constructs that predict adherence. Not only do these constructs predict self-reported medication adherence, but changes in these constructs are correlated with changes in self-reported medication adherence. These findings support the promise of text message–based interventions for medication adherence in this population and suggest likely mechanisms of action. Trial Registration: ISRCTN Registry ISRCTN13404264; https://www.isrctn.com/ISRCTN13404264 %M 35486430 %R 10.2196/30058 %U https://formative.jmir.org/2022/4/e30058 %U https://doi.org/10.2196/30058 %U http://www.ncbi.nlm.nih.gov/pubmed/35486430 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e32625 %T Adherence to a Multidisciplinary Lifestyle Program for Patients With Atrial Fibrillation and Obesity: Feasibility Study %A Tenbult,Nicole %A Kraal,Jos %A Brouwers,Rutger %A Spee,Ruud %A Eijsbouts,Sabine %A Kemps,Hareld %+ Telemedicine and Rehabilitation in Chronic Disease, Flow, Center for Prevention, Máxima MC, Dominee Theodor Fliednerstraat 1, Veldhoven/Eindhoven, 5631 BM, Netherlands, 31 040 8888220, nicole.van.limpt@mmc.nl %K cardiac rehabilitation %K atrial fibrillation %K obesity %K participation %K completion %K adherence %K lifestyle %D 2022 %7 29.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Atrial fibrillation is commonly associated with obesity. Observational studies have shown that weight loss is associated with improved prognosis and a decrease in atrial fibrillation frequency and severity. However, despite these benefits, nonadherence to lifestyle programs is common. Objective: In this study, we evaluated adherence to and feasibility of a multidisciplinary lifestyle program focusing on behavior change in patients with atrial fibrillation and obesity. Methods: Patients with atrial fibrillation and obesity participated in a 1-year goal-oriented cardiac rehabilitation program. After baseline assessment, the first 3 months included a cardiac rehabilitation intervention with 4 fixed modules: lifestyle counseling (with an advanced nurse practitioner), exercise training, dietary consultation, and psychosocial therapy; relaxation sessions were an additional optional treatment module. An advanced nurse practitioner monitored the personal lifestyle of each individual patient, with assessments and consultations at 3 months (ie, immediately after the intervention) and at the end of the year (ie, 9 months after the intervention). At each timepoint, level of physical activity, personal goals and progress, atrial fibrillation symptoms and frequency (Atrial Fibrillation Severity Scale), psychosocial stress (Generalized Anxiety Disorder–7), and depression (Patient Health Questionnaire–9) were assessed. The primary endpoints were adherence (defined as the number of visits attended as percentage of the number of planned visits) and completion rates of the cardiac rehabilitation intervention (defined as performing at least of 80% of the prescribed sessions). In addition, we performed an exploratory analysis of effects of the cardiac rehabilitation program on weight and atrial fibrillation symptom frequency and severity. Results: Patients with atrial fibrillation and obesity (male: n=8; female: n=2; age: mean 57.2 years, SD 9.0; baseline weight: mean 107.2 kg, SD 11.8; baseline BMI: mean 32.4 kg/m2, SD 3.5) were recruited. Of the 10 participants, 8 participants completed the 3-month cardiac rehabilitation intervention, and 2 participants did not complete the cardiac rehabilitation intervention (both because of personal issues). Adherence to the fixed treatment modules was 95% (mean 3.8 sessions attended out of mean 4 planned) for lifestyle counseling, 86% (mean 15.2 sessions attended out of mean 17.6 planned) for physiotherapy sessions, 88% (mean 3.7 sessions attended out of mean 4.1 planned) for dietician consultations, and 60% (mean 0.6 sessions attended out of mean 1.0 planned) for psychosocial therapy; 70% of participants (7/10) were referred to the optional relaxation sessions, for which adherence was 86% (mean 2 sessions attended out of mean 2.4 planned). The frequency of atrial fibrillation symptoms was reduced immediately after the intervention (before: mean 35.6, SD 3.8; after: mean 31.2, SD 3.3), and this was sustained at 12 months (mean 24.8, SD 3.2). The severity of atrial fibrillation complaints immediately after the intervention (mean 20.0, SD 3.7) and at 12 months (mean 9.3, SD 3.6) were comparable to that at baseline (mean 16.6, SD 3.3). Conclusions: A 1-year multidisciplinary lifestyle program for obese patients with atrial fibrillation was found to be feasible, with high adherence and completion rates. Exploratory analysis revealed a sustained reduction in atrial fibrillation symptoms; however, these results remain to be confirmed in large-scale studies. %M 35486435 %R 10.2196/32625 %U https://formative.jmir.org/2022/4/e32625 %U https://doi.org/10.2196/32625 %U http://www.ncbi.nlm.nih.gov/pubmed/35486435 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e36338 %T A Framework for Femtech: Guiding Principles for Developing Digital Reproductive Health Tools in the United States %A Krishnamurti,Tamar %A Birru Talabi,Mehret %A Callegari,Lisa S %A Kazmerski,Traci M %A Borrero,Sonya %+ Division of General Internal Medicine, University of Pittsburgh, 200 Meyran Avenue, Suite 200, Pittsburgh, PA, 15213, United States, 1 4126924855, tamark@pitt.edu %K United States %K North America %K femtech %K mHealth %K health equity %K pregnancy %K women's health %K preterm birth %K contraception %K family planning %K reproductive care %K sterilization %K cystic fibrosis %K rheumatic disease %K eHealth %K mobile health %K reproductive health %K digital health %K health technology %K health outcomes %D 2022 %7 28.4.2022 %9 Viewpoint %J J Med Internet Res %G English %X The United States has abysmal reproductive health indices that, in part, reflect stark inequities experienced by people of color and those with preexisting medical conditions. The growth of “femtech,” or technology-based solutions to women’s health issues, in the public and private sectors is promising, yet these solutions are often geared toward health-literate, socioeconomically privileged, and/or relatively healthy white cis-women. In this viewpoint, we propose a set of guiding principles for building technologies that proactively identify and address these critical gaps in health care for people from socially and economically marginalized populations that are capable of pregnancy, as well as people with serious chronic medical conditions. These guiding principles require that such technologies: (1) include community stakeholders in the design, development, and deployment of the technology; (2) are grounded in person-centered frameworks; and (3) address health disparities as a strategy to advance health equity and improve health outcomes. %M 35482371 %R 10.2196/36338 %U https://www.jmir.org/2022/4/e36338 %U https://doi.org/10.2196/36338 %U http://www.ncbi.nlm.nih.gov/pubmed/35482371 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e35595 %T Training Resources Targeting Social Media Skills to Inform Rehabilitation for People Who Have an Acquired Brain Injury: Scoping Review %A Brunner,Melissa %A Rietdijk,Rachael %A Togher,Leanne %+ Faculty of Medicine and Health, University of Sydney, Level 6, Susan Wakil Health Building, Western Avenue, Eora Nation, Camperdown, 2006, Australia, 61 2 86279866, melissa.brunner@sydney.edu.au %K brain injury %K social media %K training %K social communication %K scoping review %D 2022 %7 28.4.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: In 2020 and 2021, people increasingly used the internet to connect socially and professionally. However, people with an acquired brain injury (ABI) experience challenges in using social media, and rehabilitation professionals have reported feeling underprepared to support them in its use. To date, no review of social media skills training to inform ABI rehabilitation has been conducted. Objective: This scoping review aimed to examine research on interventions addressing social media skills and safety, with a focus on people living with health conditions; free web-based resources for the general public on social media skills training; and currently available online support groups for people with ABI. Methods: An integrative scoping review was conducted, with a systematic search strategy applied in March and November 2020 across OvidSP (MEDLINE, AMED, PsycINFO, and Embase), Scopus, Web of Science, CINAHL, Google Scholar, Google, and Facebook. The data collected were critically appraised and synthesized to describe the key content and features of social media training resources. Results: This review identified 47 peer-reviewed academic articles, 48 social media training websites, and 120 online support groups for people with ABI. A key recommendation was interactive training with practical components addressing cybersafety, how to use platforms, and how to connect with others. However, no social media training resources that were relevant and accessible for people with ABI were identified. Conclusions: Training resources to support people with ABI in safely using social media are limited. The key content to be addressed and the features to be incorporated into web-based social media training were determined, including the need for interactive training that is co-designed and safe and incorporates practical components that support people with ABI. These findings can be used to inform the development of web-based evidence-based support for people with ABI who may be vulnerable when participating in social media. %M 35482369 %R 10.2196/35595 %U https://www.jmir.org/2022/4/e35595 %U https://doi.org/10.2196/35595 %U http://www.ncbi.nlm.nih.gov/pubmed/35482369 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 5 %N 2 %P e35625 %T A Text Messaging Intervention to Support Latinx Family Caregivers of Individuals With Dementia (CuidaTEXT): Development and Usability Study %A Perales-Puchalt,Jaime %A Acosta-Rullán,Mariola %A Ramírez-Mantilla,Mariana %A Espinoza-Kissell,Paul %A Vidoni,Eric %A Niedens,Michelle %A Ellerbeck,Edward %A Hinton,Ladson %A Loera,Linda %A Ramírez,A Susana %A Lara,Esther %A Watts,Amber %A Williams,Kristine %A Resendez,Jason %A Burns,Jeffrey %+ Alzheimer’s Disease Research Center, School of Medicine, University of Kansas Medical Center, 4350 Shawnee Mission Parkway, Fairway, KS, 66205, United States, 1 913 588 3716, jperales@kumc.edu %K Latinx individuals %K mHealth %K dementia %K caregiving %D 2022 %7 28.4.2022 %9 Original Paper %J JMIR Aging %G English %X Background: Latinx family caregivers of individuals with dementia face many barriers to caregiver support access. Interventions to alleviate these barriers are urgently needed. Objective: This study aimed to describe the development of CuidaTEXT, a tailored SMS text messaging intervention to support Latinx family caregivers of individuals with dementia. Methods: CuidaTEXT is informed by the stress process framework and social cognitive theory. We developed and refined CuidaTEXT using a mixed methods approach that included thematic analysis and descriptive statistics. We followed 6 user-centered design stages, namely, the selection of design principles, software vendor collaboration, evidence-based foundation, caregiver and research and clinical advisory board guidance, sketching and prototyping, and usability testing of the prototype of CuidaTEXT among 5 Latinx caregivers. Results: CuidaTEXT is a bilingual 6-month-long SMS text messaging–based intervention tailored to caregiver needs that includes 1-3 daily automatic messages (n=244) about logistics, dementia education, self-care, social support, end of life, care of the person with dementia, behavioral symptoms, and problem-solving strategies; 783 keyword-driven text messages for further help with the aforementioned topics; live chat interaction with a coach for further help; and a 19-page reference booklet summarizing the purpose and functions of the intervention. The 5 Latinx caregivers who used the prototype of CuidaTEXT scored an average of 97 out of 100 on the System Usability Scale. Conclusions: CuidaTEXT’s prototype demonstrated high usability among Latinx caregivers. CuidaTEXT’s feasibility is ready to be tested. %M 35482366 %R 10.2196/35625 %U https://aging.jmir.org/2022/2/e35625 %U https://doi.org/10.2196/35625 %U http://www.ncbi.nlm.nih.gov/pubmed/35482366 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e35108 %T Promoting Health Behavior Change in the Preconception Period: Combined Approach to Intervention Planning %A Scott,Jodie %A Oxlad,Melissa %A Dodd,Jodie %A Szabo,Claudia %A Deussen,Andrea %A Turnbull,Deborah %+ School of Psychology, The University of Adelaide, 230 North Terrace, Adelaide, 5005, Australia, 61 8 8313 4455, jodie.scott@adelaide.edu.au %K intervention mapping %K preconception %K behavior change %K healthy lifestyle %K maternal health %K weight management %D 2022 %7 28.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Half of women begin pregnancy above the healthy weight range, increasing the risk of complications and adversely affecting the lifelong health of their babies. Maternal obesity remains the strongest risk factor for offspring obesity across childhood, adolescence, and adulthood. Previous research suggests that women should be encouraged to be within a healthy weight range before conception to improve health outcomes. Objective: We outlined the intervention planning and design process to develop an evidence-informed eHealth intervention to promote weight management. The intervention, based on psychological theories and behavior change techniques, has been developed for women affected by overweight or obesity who intend to become pregnant. The Begin Better web application is part of an integrated program being evaluated in a clinical trial to assess if weight management before pregnancy can influence clinical outcomes for mothers and babies. Methods: Our intervention development process was guided by intervention mapping and person-based methods. This study documents steps 2 to 4 of a 6-step iterative intervention mapping approach informed by the Information-Motivation-Behavioral Skills model and the findings of a previous interview study. We defined behavior change objectives for each of the Information-Motivation-Behavioral Skills behavioral determinants as well as theory-based behavior change techniques and practical strategies. We also used persuasive system design principles to assist in translating these strategies into a digital environment. Results: The resultant intervention comprises nutritional and physical activity content along with psychological strategies, which are notably absent from mainstream weight management programs. Strategies to increase motivation, garner social support, and promote self-care are integral to maintaining engagement with the intervention, which aims to improve lifestyle behaviors and enhance well-being. Important elements include tracking mechanisms for percentage progress toward goals to enable feedback on behaviors and outcomes; in-application messages of praise on entry of goals or habits; and strategies to prompt habit formation and action planning via small, easily achievable steps toward positive change. Conclusions: Design decisions and processes for idea generation about intervention content, format, and delivery are often not reported. In this study, we respond to this gap in the literature and outline a process that is potentially transferable to the development of other interventions. %M 35482370 %R 10.2196/35108 %U https://formative.jmir.org/2022/4/e35108 %U https://doi.org/10.2196/35108 %U http://www.ncbi.nlm.nih.gov/pubmed/35482370 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e34253 %T Fidelity to Program Specification of the National Health Service Digital Diabetes Prevention Program Behavior Change Technique Content and Underpinning Theory: Document Analysis %A Hawkes,Rhiannon E %A Miles,Lisa M %A French,David P %+ Manchester Centre for Health Psychology, Division of Psychology and Mental Health, University of Manchester, Coupland 1 Building, Oxford Road, Manchester, M13 9PL, United Kingdom, 44 0161 275 2605, david.french@manchester.ac.uk %K diabetes prevention %K digital interventions %K behavior change %K fidelity %D 2022 %7 27.4.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The National Health Service (NHS) Diabetes Prevention Program is a behavior change intervention for adults in England who are identified as being at high risk of developing type 2 diabetes. The face-to-face service was launched in 2016, followed by a digital service (NHS Digital Diabetes Prevention Program [NHS-DDPP]) in 2019. A total of 4 service providers were commissioned to deliver the NHS-DDPP and were required to deliver the digital service in line with a program specification detailing the key intervention content. The fidelity of the behavior change content in the digital service (ie, the extent to which the program is delivered as intended) is currently unknown. Digital interventions may allow higher fidelity as staff do not have to be trained to deliver all intervention content. Assessing fidelity of the intervention design is particularly important to establish the planned behavior change content in the NHS-DDPP and the extent to which this adheres to the program specification. This is the first known independent assessment of design fidelity in a large-scale digital behavior change intervention. Objective: This study aims to assess the fidelity of the behavior change content in each of the 4 NHS-DDPP providers’ intervention designs to the full program specification. Methods: We conducted a document review of each provider’s NHS-DDPP intervention design, along with interviews with program developers employed by the 4 digital providers (n=6). Providers’ intervention design documents and interview transcripts were coded for behavior change techniques (BCTs; ie, the active ingredients of the intervention) using the Behavior Change Technique Taxonomy version 1 and underpinning theory using the Theory Coding Scheme framework. The BCTs identified in each digital provider’s intervention design were compared with the 19 BCTs included in the program specification. Results: Of the 19 BCTs specified in the program specification, the 4 providers planned to deliver 16 (84%), 17 (89%), 16 (84%), and 16 (84%) BCTs, respectively. An additional 41 unspecified BCTs were included in at least one of the 4 digital providers’ intervention designs. By contrast, inconsistent use of the underpinning theory was apparent across providers, and none of the providers had produced a logic model to explain how their programs were expected to work. All providers linked some of their planned BCTs to theoretical constructs; however, justification for the inclusion of other BCTs was not described. Conclusions: The fidelity of BCT content in the NHS-DDPP was higher than that previously documented for the face-to-face service. Thus, if service users engage with the NHS-DDPP, this should increase the effectiveness of the program. However, given that a clear theoretical underpinning supports the translation of BCTs in intervention designs to intervention delivery, the absence of a logic model describing the constructs to be targeted by specific BCTs is potentially problematic. %M 35476035 %R 10.2196/34253 %U https://www.jmir.org/2022/4/e34253 %U https://doi.org/10.2196/34253 %U http://www.ncbi.nlm.nih.gov/pubmed/35476035 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 4 %P e33080 %T Comparing the Ratio of Therapist Support to Internet Sessions in a Blended Therapy Delivered to Trauma-Exposed Veterans: Quasi-experimental Comparison Study %A Cloitre,Marylene %A Amspoker,Amber Bush %A Fletcher,Terri L %A Hogan,Julianna B %A Jackson,Christie %A Jacobs,Adam %A Shammet,Rayan %A Speicher,Sarah %A Wassef,Miryam %A Lindsay,Jan %+ National Center for PTSD Dissemination and Training Division, Veterans Administration Palo Alto Health Care System, 795 Willow Road, Palo Alto, CA, 94025, United States, 1 415 603 8093, marylene.cloitre@gmail.com %K PTSD %K depression %K veterans %K blended therapy %K iCBT %K web-based %K webSTAIR %K noninferiority %K mental health %K digital health %D 2022 %7 27.4.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Blended models of therapy, which incorporate elements of both internet and face-to-face methods, have been shown to be effective, but therapists and patients have expressed concerns that fewer face-to-face therapy sessions than self-guided internet sessions may be associated with lower therapeutic alliance, lower program completion rates, and poorer outcomes. Objective: A multisite quasi-experimental comparison study with a noninferiority design implemented in routine clinical care was used to assess webSTAIR, a 10-module blended therapy derived from STAIR (skills training in affective and interpersonal regulation) for trauma-exposed individuals delivered with 10 weekly therapist sessions (termed Coach10) compared to 5 biweekly sessions (Coach5). It was hypothesized that Coach5 would be as good as Coach10 in a range of outcomes. Methods: A total of 202 veterans were enrolled in the study with 101 assigned to Coach5 and 101 to Coach10. Posttraumatic stress disorder (PTSD) symptoms, depression, emotion regulation, interpersonal problems, and social functioning measures were collected pre-, mid-, and posttreatment, and at a 3-month follow-up. Noninferiority analyses were conducted on symptom outcome measures. Comparisons were made of continuous and categorical measures regarding participant and therapist activities. Results: Participants reported moderate to severe levels of baseline PTSD, depression, or both. Significant reductions were obtained in all symptom measures posttreatment and at the 3-month follow up. Coach5 was not inferior to Coach10 in any outcome. Therapeutic alliance was at an equivalently high level across the 2 treatment conditions; completion rates and web usage were similar. Total session time was substantially less for the Coach5 therapists than the Coach10 therapists. Both programs were associated with a low, but equal number of therapist activities related to scheduling and crisis or motivational sessions. Conclusions: A blended model delivered with 5 sessions of therapist support was noninferior to 10 sessions in individuals with moderate to severe symptoms. Future studies identifying patient characteristics as moderators of outcomes with high versus low doses of therapist support will help create flexible, technology-based intervention programming. %M 35475777 %R 10.2196/33080 %U https://mental.jmir.org/2022/4/e33080 %U https://doi.org/10.2196/33080 %U http://www.ncbi.nlm.nih.gov/pubmed/35475777 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e32630 %T The Effects of Health Care Chatbot Personas With Different Social Roles on the Client-Chatbot Bond and Usage Intentions: Development of a Design Codebook and Web-Based Study %A Nißen,Marcia %A Rüegger,Dominik %A Stieger,Mirjam %A Flückiger,Christoph %A Allemand,Mathias %A v Wangenheim,Florian %A Kowatsch,Tobias %+ Centre for Digital Health Interventions, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, Zurich, 8092, Switzerland, 41 44 632 65 66, mnissen@ethz.ch %K chatbot %K conversational agent %K social roles %K interpersonal closeness %K social role theory %K working alliance %K design %K persona %K digital health intervention %K web-based experiment %D 2022 %7 27.4.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The working alliance refers to an important relationship quality between health professionals and clients that robustly links to treatment success. Recent research shows that clients can develop an affective bond with chatbots. However, few research studies have investigated whether this perceived relationship is affected by the social roles of differing closeness a chatbot can impersonate and by allowing users to choose the social role of a chatbot. Objective: This study aimed at understanding how the social role of a chatbot can be expressed using a set of interpersonal closeness cues and examining how these social roles affect clients’ experiences and the development of an affective bond with the chatbot, depending on clients’ characteristics (ie, age and gender) and whether they can freely choose a chatbot’s social role. Methods: Informed by the social role theory and the social response theory, we developed a design codebook for chatbots with different social roles along an interpersonal closeness continuum. Based on this codebook, we manipulated a fictitious health care chatbot to impersonate one of four distinct social roles common in health care settings—institution, expert, peer, and dialogical self—and examined effects on perceived affective bond and usage intentions in a web-based lab study. The study included a total of 251 participants, whose mean age was 41.15 (SD 13.87) years; 57.0% (143/251) of the participants were female. Participants were either randomly assigned to one of the chatbot conditions (no choice: n=202, 80.5%) or could freely choose to interact with one of these chatbot personas (free choice: n=49, 19.5%). Separate multivariate analyses of variance were performed to analyze differences (1) between the chatbot personas within the no-choice group and (2) between the no-choice and the free-choice groups. Results: While the main effect of the chatbot persona on affective bond and usage intentions was insignificant (P=.87), we found differences based on participants’ demographic profiles: main effects for gender (P=.04, ηp2=0.115) and age (P<.001, ηp2=0.192) and a significant interaction effect of persona and age (P=.01, ηp2=0.102). Participants younger than 40 years reported higher scores for affective bond and usage intentions for the interpersonally more distant expert and institution chatbots; participants 40 years or older reported higher outcomes for the closer peer and dialogical-self chatbots. The option to freely choose a persona significantly benefited perceptions of the peer chatbot further (eg, free-choice group affective bond: mean 5.28, SD 0.89; no-choice group affective bond: mean 4.54, SD 1.10; P=.003, ηp2=0.117). Conclusions: Manipulating a chatbot’s social role is a possible avenue for health care chatbot designers to tailor clients’ chatbot experiences using user-specific demographic factors and to improve clients’ perceptions and behavioral intentions toward the chatbot. Our results also emphasize the benefits of letting clients freely choose between chatbots. %M 35475761 %R 10.2196/32630 %U https://www.jmir.org/2022/4/e32630 %U https://doi.org/10.2196/32630 %U http://www.ncbi.nlm.nih.gov/pubmed/35475761 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 2 %P e35671 %T Understanding People With Chronic Pain Who Use a Cognitive Behavioral Therapy–Based Artificial Intelligence Mental Health App (Wysa): Mixed Methods Retrospective Observational Study %A Meheli,Saha %A Sinha,Chaitali %A Kadaba,Madhura %+ Wysa Inc, 131 Dartmouth St, Boston, MA, United States, 1 916 753 7824, chaitali@wysa.io %K chronic pain %K digital mental health %K mobile health %K mHealth %K pain management %K artificial intelligence %K cognitive behavioral therapy %K conversational agent %K software agent %K pain conditions %K depression %K anxiety %D 2022 %7 27.4.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Digital health interventions can bridge barriers in access to treatment among individuals with chronic pain. Objective: This study aimed to evaluate the perceived needs, engagement, and effectiveness of the mental health app Wysa with regard to mental health outcomes among real-world users who reported chronic pain and engaged with the app for support. Methods: Real-world data from users (N=2194) who reported chronic pain and associated health conditions in their conversations with the mental health app were examined using a mixed methods retrospective observational study. An inductive thematic analysis was used to analyze the conversational data of users with chronic pain to assess perceived needs, along with comparative macro-analyses of conversational flows to capture engagement within the app. Additionally, the scores from a subset of users who completed a set of pre-post assessment questionnaires, namely Patient Health Questionnaire-9 (PHQ-9) (n=69) and Generalized Anxiety Disorder Assessment-7 (GAD-7) (n=57), were examined to evaluate the effectiveness of Wysa in providing support for mental health concerns among those managing chronic pain. Results: The themes emerging from the conversations of users with chronic pain included health concerns, socioeconomic concerns, and pain management concerns. Findings from the quantitative analysis indicated that users with chronic pain showed significantly greater app engagement (P<.001) than users without chronic pain, with a large effect size (Vargha and Delaney A=0.76-0.80). Furthermore, users with pre-post assessments during the study period were found to have significant improvements in group means for both PHQ-9 and GAD-7 symptom scores, with a medium effect size (Cohen d=0.60-0.61). Conclusions: The findings indicate that users look for tools that can help them address their concerns related to mental health, pain management, and sleep issues. The study findings also indicate the breadth of the needs of users with chronic pain and the lack of support structures, and suggest that Wysa can provide effective support to bridge the gap. %M 35314422 %R 10.2196/35671 %U https://humanfactors.jmir.org/2022/2/e35671 %U https://doi.org/10.2196/35671 %U http://www.ncbi.nlm.nih.gov/pubmed/35314422 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 8 %N 2 %P e36788 %T Mobile-Based Self-management Application Requirements for Patients With Gastric Cancer: Quantitative Descriptive Study of Specialist and Patient Perspectives %A Yazdanian,Azade %A Mehdizadeh,Hamed %A Balaghafari,Azita %A Kahouei,Mahdi %A Masoudinezhad,Maede %+ Department of Health Information Technology, School of Allied Medical Sciences, Mazandaran University of Medical Sciences, MAZUMS Campus, Farah Abad Blvd, Sari, 4818911916, Iran, 98 1133543246, hamed13sep@gmail.com %K digital health, eHealth %K telehealth %K mHealth %K mobile app %K self-management %K patient education %K needs assessment, requirements analysis, stomach neoplasm, gastric cancer %D 2022 %7 27.4.2022 %9 Original Paper %J JMIR Cancer %G English %X Background: Gastric cancer is one of the most common gastrointestinal cancers. Patients with gastric cancer experience disabilities and complications that lead to reduced quality of life. Empowering these patients by providing them with information and self-management skills can help reduce side effects and improve their quality of life. Objective: The aim of this study was to identify the user requirements for developing a mobile-based self-management app to support patients with gastric cancer. Methods: Data were analyzed using descriptive statistics and frequency distribution reports using IBM SPSS Statistics software. Results: All of the data elements and functional requirements except “data recording times” and “weight changes in graphs” were identified as essential by clinical experts and patients. Among the functional requirements required in a gastric cancer self-management app, the capabilities related to informing, announcing warnings, and reminders are included. In the demographic data section, most patients (14/26, 53%) did not comment on the importance of recording data such as name, surname, and place of residence, and the demographic data section was met with less agreement from patients than clinicians. Conclusions: Applying the requirements mentioned in this study can improve the self-management of patients with gastric cancer. Such apps can play an important role in empowering patients and improving their quality of life. However, the apps need to be designed and implemented to see how they can meet users’ requirements. %M 35475920 %R 10.2196/36788 %U https://cancer.jmir.org/2022/2/e36788 %U https://doi.org/10.2196/36788 %U http://www.ncbi.nlm.nih.gov/pubmed/35475920 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e34654 %T Live Video Mind-Body Program for Patients With Knee Osteoarthritis, Comorbid Depression, and Obesity: Development and Feasibility Pilot Study %A Mace,Ryan A %A Greenberg,Jonathan %A Lemaster,Nicole %A Duarte,Brooke %A Penn,Terence %A Kanaya,Millan %A Doorley,James D %A Burris,Jessica L %A Jacobs,Cale A %A Vranceanu,Ana-Maria %+ Department of Orthopaedic Surgery & Sports Medicine, University of Kentucky, 740 S Limestone, Suite K401, Lexington, KY, 40536-0284, United States, 1 (859) 797 8197, cale.jacobs@uky.edu %K knee osteoarthritis %K depression %K obesity %K mind-body %K physical activity %K mixed-methods %K mobile phone %D 2022 %7 27.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Knee osteoarthritis (KOA) is the most common joint disorder in the United States and a leading cause of disability. Depression and obesity are highly comorbid with KOA and accelerate knee degeneration and disability through biopsychosocial mechanisms. Mind-body physical activity programs can engage biological, mechanical, and psychological mechanisms to improve outcomes in KOA, but such programs are not currently available. Objective: This mixed methods study aims to adapt a mind-body activity program for the unique needs of patients with KOA, depression, and obesity (GetActive-OA) delivered via live video. Methods: Participants were adults (aged ≥45 years) from rural Kentucky with obesity (BMI≥30 kg/m2), idiopathic KOA with mild to moderate radiographic changes, and elevated depressive symptoms (9-item Patient Health Questionnaire ≥10) recruited from 2 orthopedic centers. In phase 1, we developed GetActive-OA and the study protocol using qualitative focus group feedback from the study population (N=9; 2 focus groups, 90 minutes) and multidisciplinary expertise from clinical psychologists and orthopedic researchers. In phase 2, we explored the initial feasibility, credibility, and acceptability of GetActive-OA, live video delivery, and study procedures via an open pilot with exit interviews (N=5; 1 group). This research was guided by National Institutes of Health (NIH) model stage IA. Results: Phase 1 qualitative analyses revealed nuanced information about challenges with coping and increasing activity, high interest in a mind-body activity program, program participation facilitators (flexibility with technology) and barriers (amotivation and forgetfulness), and perceived challenges with data collection procedures (blood and urine samples and homework). Phase 2 quantitative analyses showed that GetActive-OA met most a priori feasibility markers: acceptability (80%), expectancy (100%), credibility (100%), clinician adherence (90%), homework adherence (80%), questionnaire data collection (100%), program satisfaction (100%), and safety (100%). Adherence to ActiGraph wear (80% baseline, 20% posttest) and collection of blood samples (60%) were low. Participation in GetActive-OA was associated with signals of improvements in general coping (Cohen d=2.41), pain catastrophizing (Cohen d=1.24), depression (Cohen d=0.88), anxiety (Cohen d=0.78), self-efficacy (Cohen d=0.73), pain (Cohen d=0.39), and KOA symptoms (Cohen d=0.36). Qualitative exit interviews confirmed quantitative findings and provided valuable information to optimize the program and protocol. Conclusions: Patients with KOA, depression, and obesity from rural Kentucky were interested in a live video mind-body activity program. GetActive-OA shows promise; however, the program and protocol require further NIH stage I refinement before formal efficacy testing (NIH model stage II). International Registered Report Identifier (IRRID): RR2-10.1016/j.conctc.2021.100720 %M 35475787 %R 10.2196/34654 %U https://formative.jmir.org/2022/4/e34654 %U https://doi.org/10.2196/34654 %U http://www.ncbi.nlm.nih.gov/pubmed/35475787 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 9 %N 2 %P e34819 %T Exercise-Based Real-time Telerehabilitation for Older Adult Patients Recently Discharged After Transcatheter Aortic Valve Implantation: Mixed Methods Feasibility Study %A Brocki,Barbara Cristina %A Andreasen,Jan Jesper %A Aaroe,Jens %A Andreasen,Jane %A Thorup,Charlotte Brun %+ Department of Physiotherapy and Occupational Therapy, Aalborg University Hospital, Hobrovej 18-22, Aalborg, 9000, Denmark, 45 97664238, bcb@rn.dk %K telerehabilitation %K transcatheter aortic valve implantation %K cardiac surgery %K cardiac rehabilitation %K exercise training %K older adults %K tablet %D 2022 %7 26.4.2022 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: The use of telehealth technology to improve functional recovery following transcatheter aortic valve implantation (TAVI) has not been investigated. Objective: In this study, we aimed to examine the feasibility of exercise-based cardiac telerehabilitation after TAVI. Methods: This was a single-center, prospective, nonrandomized study using a mixed methods approach. Data collection included testing, researchers’ observations, logbooks, and individual patient interviews, which were analyzed using a content analysis approach. The intervention lasted 3 weeks and consisted of home-based web-based exercise training, an activity tracker, a TAVI information website, and 1 web-based session with a nurse. Results: Of the initially included 13 patients, 5 (40%) completed the study and were interviewed; the median age was 82 (range 74-84) years, and the sample comprised 3 men and 2 women. Easy access to supervised exercise training at home with real-time feedback and use of the activity tracker to count daily steps were emphasized by the patients who completed the intervention. Reasons for patients not completing the program included poor data coverage, participants’ limited information technology skills, and a lack of functionality in the systems used. No adverse events were reported. Conclusions: Exercise-based telerehabilitation for older people after TAVI, in the population as included in this study, and delivered as a web-based intervention, does not seem feasible, as 60% (8/13) of patients did not complete the study. Those completing the intervention highly appreciated the real-time feedback during the web-based training sessions. Future studies should address aspects that support retention rates and enhance patients’ information technology skills. %M 35471263 %R 10.2196/34819 %U https://rehab.jmir.org/2022/2/e34819 %U https://doi.org/10.2196/34819 %U http://www.ncbi.nlm.nih.gov/pubmed/35471263 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e36143 %T Developing Mobile Health Interventions With Implementation in Mind: Application of the Multiphase Optimization Strategy (MOST) Preparation Phase to Diabetes Prevention Programming %A MacPherson,Megan %A Merry,Kohle %A Locke,Sean %A Jung,Mary %+ School of Health and Exercise Sciences, University of British Columbia, 3333 University Way, Kelowna, BC, V1V 1V7, Canada, 1 2508079670, mary.jung@ubc.ca %K text messaging %K prediabetic state %K telemedicine %K telecommunications %K exercise %K diet %K preventive medicine %K mHealth %K intervention development %K behavior change %K mobile phone %D 2022 %7 26.4.2022 %9 Viewpoint %J JMIR Form Res %G English %X With thousands of mobile health (mHealth) solutions on the market, patients and health care providers struggle to identify which solution to use and prescribe. The lack of evidence-based mHealth solutions may be because of limited research on intervention development and the continued use of traditional research methods for mHealth evaluation. The Multiphase Optimization Strategy (MOST) is a framework that aids in developing interventions that produce the best-expected outcomes (ie, effectiveness), given constraints imposed on affordability, scalability, and efficiency (also known as achieving intervention EASE). The preparation phase of the MOST highlights the importance of formative intervention development—a stage often overlooked and rarely published. The aim of the preparation phase of the MOST is to identify candidate intervention components, create a conceptual model, and define the optimization objective. Although the MOST sets these 3 targets, no guidance is provided on how to conduct quality research within the preparation phase and what specific steps can be taken to identify potential intervention components, develop the conceptual model, and achieve intervention EASE with the implementation context in mind. To advance the applicability of the MOST within the field of implementation science, this study provides an account of the methods used to develop an mHealth intervention using the MOST. Specifically, we provide an example of how to achieve the goals of the preparation phase by outlining the formative development of an mHealth-prompting intervention within a diabetes prevention program. In addition, recommendations are proposed for future researchers to consider when conducting formative research on mHealth interventions with implementation in mind. Given its considerable reach, mHealth has the potential to positively affect public health by decreasing implementation costs and improving accessibility. The MOST is well-suited for the efficient development and optimization of mHealth interventions. By using an implementation-focused lens and outlining the steps in developing an mHealth intervention using the preparation phase of the MOST, this study may guide future intervention developers toward maximizing the impact of mHealth outside academia. %M 35471473 %R 10.2196/36143 %U https://formative.jmir.org/2022/4/e36143 %U https://doi.org/10.2196/36143 %U http://www.ncbi.nlm.nih.gov/pubmed/35471473 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e29088 %T Effectiveness of Web-Based Personalized Nutrition Advice for Adults Using the eNutri Web App: Evidence From the EatWellUK Randomized Controlled Trial %A Zenun Franco,Rodrigo %A Fallaize,Rosalind %A Weech,Michelle %A Hwang,Faustina %A Lovegrove,Julie A %+ Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Whiteknights, Reading, RG6 6DZ, United Kingdom, 44 0118 378 6418, j.a.lovegrove@reading.ac.uk %K personalized nutrition %K web-based %K nutrition app %K app %K dietary intervention %K eNutri %K precision nutrition %K mHealth %K healthy eating index %K diet quality scores %K FFQ %K food frequency questionnaire %K EatWellUK %D 2022 %7 25.4.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Evidence suggests that eating behaviors and adherence to dietary guidelines can be improved using nutrition-related apps. Apps delivering personalized nutrition (PN) advice to users can provide individual support at scale with relatively low cost. Objective: This study aims to investigate the effectiveness of a mobile web app (eNutri) that delivers automated PN advice for improving diet quality, relative to general population food-based dietary guidelines. Methods: Nondiseased UK adults (aged >18 years) were randomized to PN advice or control advice (population-based healthy eating guidelines) in a 12-week controlled, parallel, single-blinded dietary intervention, which was delivered on the web. Dietary intake was assessed using the eNutri Food Frequency Questionnaire (FFQ). An 11-item US modified Alternative Healthy Eating Index (m-AHEI), which aligned with UK dietary and nutritional recommendations, was used to derive the automated PN advice. The primary outcome was a change in diet quality (m-AHEI) at 12 weeks. Participant surveys evaluated the PN report (week 12) and longer-term impact of the PN advice (mean 5.9, SD 0.65 months, after completion of the study). Results: Following the baseline FFQ, 210 participants completed at least 1 additional FFQ, and 23 outliers were excluded for unfeasible dietary intakes. The mean interval between FFQs was 10.8 weeks. A total of 96 participants were included in the PN group (mean age 43.5, SD 15.9 years; mean BMI 24.8, SD 4.4 kg/m2) and 91 in the control group (mean age 42.8, SD 14.0 years; mean BMI 24.2, SD 4.4 kg/m2). Compared with that in the control group, the overall m-AHEI score increased by 3.5 out of 100 (95% CI 1.19-5.78) in the PN group, which was equivalent to an increase of 6.1% (P=.003). Specifically, the m-AHEI components nuts and legumes and red and processed meat showed significant improvements in the PN group (P=.04). At follow-up, 64% (27/42) of PN participants agreed that, compared with baseline, they were still following some (any) of the advice received and 31% (13/42) were still motivated to improve their diet. Conclusions: These findings suggest that the eNutri app is an effective web-based tool for the automated delivery of PN advice. Furthermore, eNutri was demonstrated to improve short-term diet quality and increase engagement in healthy eating behaviors in UK adults, as compared with population-based healthy eating guidelines. This work represents an important landmark in the field of automatically delivered web-based personalized dietary interventions. Trial Registration: ClinicalTrials.gov NCT03250858; https://clinicaltrials.gov/ct2/show/NCT03250858 %M 35468093 %R 10.2196/29088 %U https://www.jmir.org/2022/4/e29088 %U https://doi.org/10.2196/29088 %U http://www.ncbi.nlm.nih.gov/pubmed/35468093 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e31835 %T Computerized Cognitive Behavioral Therapy Intervention for Depression Among Veterans: Acceptability and Feasibility Study %A Stearns-Yoder,Kelly A %A Ryan,Arthur T %A Smith,Alexandra A %A Forster,Jeri E %A Barnes,Sean M %A Brenner,Lisa A %+ Veterans Affairs Rocky Mountain Mental Illness Research Education and Clinical Center, Rocky Mountain Regional Veterans Affairs Medical Center, 1700 N Wheeling Street, Aurora, CO, 80045, United States, 1 7204151717, kelly.stearns@va.gov %K computerized cognitive behavioral therapy %K depression %K veterans %K acceptability %K feasibility %D 2022 %7 25.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Computerized cognitive behavioral therapies (cCBTs) have been developed to deliver efficient, evidence-based treatment for depression and other mental health conditions. Beating the Blues (BtB) is one of the most empirically supported cCBTs for depression. The previous trial of BtB with veterans included regular guidance by health care personnel, which increased the complexity and cost of the intervention. Objective: This study, conducted by researchers at a Veterans Affairs Medical Center, aims to test the acceptability and feasibility of unguided cCBT for depression among US military veterans. Methods: To examine the acceptability of BtB delivered without additional peer or other mental health care provider support, a before-and-after trial was conducted among United States (US) military veterans experiencing mild to moderate depressive symptoms. The feasibility of the study design for a future efficacy trial was also evaluated. Results: In total, 49 veterans completed preintervention assessments and received access to BtB, and 29 participants completed all postintervention assessments. The predetermined acceptability criterion for the intervention was met. Although the predetermined feasibility criteria regarding screening eligibility rate, number of BtB modules completed, and completion of a posttreatment assessment were not met, the results were comparable with those of other cCBT studies. Conclusions: This is the first study among US military veterans to demonstrate support for the implementation of cCBT for depression without the assistance of a mental health professional or a peer support specialist, suggesting that stand-alone computer-aided interventions may be viable. Ideas for improving feasibility in future trials based on this study are discussed. %M 35468088 %R 10.2196/31835 %U https://formative.jmir.org/2022/4/e31835 %U https://doi.org/10.2196/31835 %U http://www.ncbi.nlm.nih.gov/pubmed/35468088 %0 Journal Article %@ 2562-7600 %I JMIR Publications %V 5 %N 1 %P e36702 %T Acceptance of an Internet-Based Team Development Tool Aimed at Improving Work-Related Well-being in Nurses: Cross-sectional Study %A Broetje,Sylvia %A Bauer,Georg F %A Jenny,Gregor J %+ Center of Salutogenesis, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Hirschengraben 84, Zurich, 8001, Switzerland, 41 446344854, sylvia.libro@gmail.com %K digital intervention %K eHealth %K nurses %K online intervention %K organizational health %K technology acceptance %K UTAUT %K workplace health promotion %K mHealth %D 2022 %7 22.4.2022 %9 Original Paper %J JMIR Nursing %G English %X Background: Workplace health interventions can produce beneficial health- and business-related outcomes. However, such interventions have traditionally focused on lifestyle behaviors of individuals, mostly not considering the role of working conditions. The wecoach intervention is an internet-based tool that combines both a digital and a participatory team development approach aimed at addressing critical job demands and resources as key aspects of health-promoting working conditions. Nursing staff are particularly affected by challenging working conditions and could potentially benefit greatly. Understanding the acceptance of novel workplace health promotion approaches is a critical precursor to their successful implementation and use. Objective: This study aims to examine the factors influencing the acceptance of a digitally supported team development tool among nurse managers. Methods: A sample of 32 nurse managers from 3 German-speaking countries tested wecoach and completed our online questionnaire. Hypotheses were based on the unified theory of acceptance and use of technology (UTAUT) and the organizational health development (OHD) model and were tested using multiple regression analyses. Results: Our analyses found that merely capacities on the team level (CapTeam) significantly contributed to the acceptance of wecoach, although only after the other variables were excluded in the stepwise multiple regression analysis. The UTAUT predictors were unable to add significant variance explanation beyond that, and their inclusion masked the contribution of CapTeam. Conclusions: For the acceptance of a digitally supported participatory tool, the fit with the team, its culture, and its motivation are of critical importance, while aspects proposed by traditional acceptance models, such as the UTAUT, may not be applicable. %M 35452403 %R 10.2196/36702 %U https://nursing.jmir.org/2022/1/e36702 %U https://doi.org/10.2196/36702 %U http://www.ncbi.nlm.nih.gov/pubmed/35452403 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e30218 %T Conditions for the Successful Integration of an eHealth Tool "StopBlues" Into Community-Based Interventions in France: Results From a Multiple Correspondence Analysis %A Turmaine,Kathleen %A Dumas,Agnès %A Chevreul,Karine %A , %+ Université Paris Cité, ECEVE, UMR 1123, Inserm, 10 avenue de Verdun, Paris, 75010, France, 33 1 57 27 86 89, kathleen.turmaine@inserm.fr %K eHealth %K internet-based intervention %K community participation %K health promotion %K prevention %K mental health %D 2022 %7 22.4.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: For over a decade, digital health has held promise for enabling broader access to health information, education, and services for the general population at a lower cost. However, recent studies have shown mixed results leading to a certain disappointment regarding the benefits of eHealth technologies. In this context, community-based health promotion represents an interesting and efficient conceptual framework that could help increase the adoption of digital health solutions and facilitate their evaluation. Objective: To understand how the local implementation of the promotion of an eHealth tool, StopBlues (SB), aimed at preventing psychological distress and suicide, varied according to local contexts and if the implementation was related to the use of the tool. Methods: The study was nested within a cluster-randomized controlled trial that was conducted to evaluate the effectiveness of the promotion, with before and after observation (NCT03565562). Data from questionnaires, observations, and institutional sources were collected in 27 localities where SB was implemented. A multiple correspondence analysis was performed to assess the relations between context, type of implementation and promotion, and use of the tool. Results: Three distinct promotion patterns emerged according to the profiles of the localities that were associated with specific SB utilization rates. From highest to lowest utilization rates, they are listed as follows: the privileged urban localities, investing in health that implemented a high-intensity and digital promotion, demonstrating a greater capacity to take ownership of the project; the urban, but less privileged localities that, in spite of having relatively little experience in health policy implementation, managed to implement a traditional and high-intensity promotion; and the rural localities, with little experience in addressing health issues, that implemented low-intensity promotion but could not overcome the challenges associated with their local context. Conclusions: These findings indicate the substantial influence of local context on the reception of digital tools. The urban and socioeconomic status profiles of the localities, along with their investment and pre-existing experience in health, appear to be critical for shaping the promotion and implementation of eHealth tools in terms of intensity and use of digital communication. The more digital channels used, the higher the utilization rates, ultimately leading to the overall success of the intervention. International Registered Report Identifier (IRRID): RR2-10.1186/s13063-020-04464-2 %M 35451977 %R 10.2196/30218 %U https://www.jmir.org/2022/4/e30218 %U https://doi.org/10.2196/30218 %U http://www.ncbi.nlm.nih.gov/pubmed/35451977 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e35940 %T Unguided Computer-Assisted Self-Help Interventions Without Human Contact in Patients With Obsessive-Compulsive Disorder: Systematic Review and Meta-analysis %A Imai,Hissei %A Tajika,Aran %A Narita,Hisashi %A Yoshinaga,Naoki %A Kimura,Kenichi %A Nakamura,Hideki %A Takeshima,Nozomi %A Hayasaka,Yu %A Ogawa,Yusuke %A Furukawa,Toshi %+ Department of Health Promotion and Human Behavior, Graduate School of Medicine, School of Public Health, Kyoto University, Yoshida Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan, 81 75 753 9491, ihits@hotmail.com %K randomized controlled trial %K RCT %K information technology %K psychotherapy %K treatment adherence %K anxiety disorder %K anxiety %K OCD %K obsessive-compulsive disorder %K systematic review %K meta-analysis %K mental health %K computer-assisted %K therapy %K efficacy %K acceptability %K eHealth %K mental illness %D 2022 %7 21.4.2022 %9 Review %J J Med Internet Res %G English %X Background: Computer-assisted treatment may reduce therapist contact and costs and promote client participation. This meta-analysis examined the efficacy and acceptability of an unguided computer-assisted therapy in patients with obsessive-compulsive disorder (OCD) compared with a waiting list or attention placebo. Objective: This study aimed to evaluate the effectiveness and adherence of computer-assisted self-help treatment without human contact in patients with OCD using a systematic review and meta-analysis approach. Methods: Randomized controlled trials with participants primarily diagnosed with OCD by health professionals with clinically significant OCD symptoms as measured with validated scales were included. The interventions included self-help treatment through the internet, computers, and smartphones. We excluded interventions that used human contact. We conducted a search on PubMed, Cochrane Central Register of Controlled Trials, EMBASE, World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov, as well as the reference lists of the included studies. The risk of bias was evaluated using version 2 of the Cochrane risk-of-bias tool for randomized trials. We calculated the standardized mean differences for continuous outcomes and risk ratios for dichotomous outcomes. The primary outcomes were short-term improvement of OCD symptoms measured by validated scales and dropout for any reason. Results: We included 11 randomized controlled trials with a total of 983 participants. The results indicated that unguided computer-assisted self-help therapy was significantly more effective than a waiting list or psychological placebo (standard mean difference −0.47, 95% CI −0.73 to −0.22). Unguided computer-assisted self-help therapy had more dropouts for any reason than waiting list or psychological placebo (risk ratio 1.98, 95% CI 1.21 to 3.23). However, the quality of evidence was very low because of the risk of bias and inconsistent results among the included studies. The subgroup analysis showed that exposure response and prevention and an intervention duration of more than 4 weeks strengthen the efficacy without worsening acceptability. Only a few studies have examined the interaction between participants and systems, and no study has used gamification. Most researchers only used text-based interventions, and no study has used a mobile device. The overall risk of bias of the included studies was high and the heterogeneity of results was moderate to considerable. Conclusions: Unguided computer-assisted self-help therapy for OCD is effective compared with waiting lists or psychological placebo. An exposure response and prevention component and intervention duration of more than 4 weeks may strengthen the efficacy without worsening the acceptability of the therapy. Trial Registration: PROSPERO (International Prospective Register of Systematic Reviews) CRD42021264644; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=264644 %M 35451993 %R 10.2196/35940 %U https://www.jmir.org/2022/4/e35940 %U https://doi.org/10.2196/35940 %U http://www.ncbi.nlm.nih.gov/pubmed/35451993 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 4 %P e34005 %T A Web-Based Well-being Program for Health Care Workers (Thrive): Protocol for a Randomized Controlled Trial %A Egan,Luke A %A Mulcahy,Mary %A Tuqiri,Karen %A Gatt,Justine M %+ Neuroscience Research Australia, Margarete Ainsworth Building, Barker St, Randwick, 2031, Australia, 61 2 9399 1812, j.gatt@neura.edu.au %K well-being %K Composure, Own-worth, Mastery, Positivity, Achievement, and Satisfaction for Wellbeing %K COMPAS-W %K mental health %K resilience %K health care %K hospital %K brain %K neuroscience %K online %K randomized controlled trial %K RCT %D 2022 %7 21.4.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Mental health has come to be understood as not merely the absence of mental illness but also the presence of mental well-being, and recent interventions have sought to increase well-being in various populations. A population that deserves particular attention is that of health care workers, whose occupations entail high levels of stress, especially given the ongoing COVID-19 pandemic. A neuroscience-based web-based well-being program for health care workers—the Thrive program—has been newly developed to promote habits and activities that contribute to brain health and overall mental well-being. Objective: This paper describes the protocol for a randomized controlled trial whose objective is to evaluate the Thrive program in comparison with an active control condition to measure whether the program is effective at increasing well-being and decreasing symptoms of psychological distress in health care workers at a designated Australian hospital. Methods: The trial will comprise two groups (intervention vs active control) and 4 measurement occasions over a 12-week period. A survey will be administered in each of weeks 0, 4, 8, and 12, and the well-being program will be delivered in weeks 1-7 (via web-based video presentations or digital pamphlets). Each of the 4 surveys will comprise a range of questionnaires to measure well-being, psychological distress, and other key variables. The planned analyses will estimate group-by-time interaction effects to test the hypothesis that mental health will increase over time in the intervention condition relative to the active control condition. Results: The Thrive program was delivered to a small number of wards at the hospital between February 2021 and July 2021, and it will be delivered to the remaining wards from October 2021 to December 2021. A power calculation has recommended a sample size of at least 200 participants in total. A linear mixed model will be used to estimate the interaction effects. Conclusions: This trial seeks to evaluate a new web-based well-being program for health care workers at a major public hospital. It will contribute to the growing body of research on mental well-being and ways to promote it. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621000027819; https://tinyurl.com/58wwjut9 International Registered Report Identifier (IRRID): DERR1-10.2196/34005 %M 35451973 %R 10.2196/34005 %U https://www.researchprotocols.org/2022/4/e34005 %U https://doi.org/10.2196/34005 %U http://www.ncbi.nlm.nih.gov/pubmed/35451973 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e33886 %T Message Frame–Tailoring in Digital Health Communication: Intervention Redesign and Usability Testing %A van Strien-Knippenberg,Inge S %A Altendorf,Maria B %A Hoving,Ciska %A van Weert,Julia C M %A Smit,Eline S %+ Department of Communication Science, Amsterdam School of Communication Research, University of Amsterdam, Nieuwe Achtergracht 166, Amsterdam, 1018 WV, Netherlands, 31 645139863, i.vanstrien@amsterdamumc.nl %K digital health communication %K web-based computer tailoring %K smoking cessation intervention %K message framing %K usability testing %D 2022 %7 21.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Message frame–tailoring based on the need for autonomy is a promising strategy to improve the effectiveness of digital health communication interventions. An example of a digital health communication intervention is Personal Advice in Stopping smoking (PAS), a web-based content-tailored smoking cessation program. PAS was effective in improving cessation success rates, but its effect sizes were small and disappeared after 6 months. Therefore, investigating whether message frame–tailoring based on the individual’s need for autonomy might improve effect rates is worthwhile. However, to our knowledge, this has not been studied previously. Objective: To investigate whether adding message frame–tailoring based on the need for autonomy increases the effectiveness of content-tailored interventions, the PAS program was redesigned to incorporate message frame–tailoring also. This paper described the process of redesigning the PAS program to include message frame–tailoring, providing smokers with autonomy-supportive or controlling message frames—depending on their individual need for autonomy. Therefore, we aimed to extend framing theory, tailoring theory, and self-determination theory. Methods: Extension of the framing theory, tailoring theory, and self-determination theory by redesigning the PAS program to include message frame–tailoring was conducted in close collaboration with scientific and nonscientific smoking cessation experts (n=10), smokers (n=816), and communication science students (n=19). Various methods were used to redesign the PAS program to include message frame–tailoring with optimal usability: usability testing, think-aloud methodology, heuristic evaluations, and a web-based experiment. Results: The most autonomy-supportive and controlling message frames were identified, the cutoff point for the need for autonomy to distinguish between people with high and those with low need for autonomy was determined, and the usability was optimized. Conclusions: This resulted in a redesigned digital health communication intervention that included message frame–tailoring and had optimal usability. A detailed description of the redesigning process of the PAS program is provided. Trial Registration: Netherlands Trial Register NL6512 (NRT6700); https://www.trialregister.nl/trial/6512 %M 35451988 %R 10.2196/33886 %U https://formative.jmir.org/2022/4/e33886 %U https://doi.org/10.2196/33886 %U http://www.ncbi.nlm.nih.gov/pubmed/35451988 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e33320 %T Publicly Available, Interactive Web-Based Tools to Support Advance Care Planning: Systematic Review %A Dupont,Charlèss %A Smets,Tinne %A Monnet,Fanny %A Pivodic,Lara %A De Vleminck,Aline %A Van Audenhove,Chantal %A Van den Block,Lieve %+ End-of-Life Care Research Group, Vrije Universiteit Brussel & Ghent University, Laarbeeklaan 103, Brussels, 1090, Belgium, 32 484 433 257, charless.dupont@vub.be %K advance care planning %K systematic review %K web-based tools %K health communication %K quality of online content %D 2022 %7 20.4.2022 %9 Review %J J Med Internet Res %G English %X Background: There is an increasing number of interactive web-based advance care planning (ACP) support tools, which are web-based aids in any format encouraging reflection, communication, and processing of publicly available information, most of which cannot be found in the peer-reviewed literature. Objective: This study aims to conduct a systematic review of web-based ACP support tools to describe the characteristics, readability, and quality of content and investigate whether and how they are evaluated. Methods: We systematically searched the web-based gray literature databases OpenGrey, ClinicalTrials.gov, ProQuest, British Library, Grey Literature in the Netherlands, and Health Services Research Projects in Progress, as well as Google and app stores, and consulted experts using the following eligibility criteria: web-based, designed for the general population, accessible to everyone, interactive (encouraging reflection, communication, and processing of information), and in English or Dutch. The quality of content was evaluated using the Quality Evaluation Scoring Tool (score 0-28—a higher score indicates better quality). To synthesize the characteristics of the ACP tools, readability and quality of content, and whether and how they were evaluated, we used 4 data extraction tables. Results: A total of 30 tools met the eligibility criteria, including 15 (50%) websites, 10 (33%) web-based portals, 3 (10%) apps, and 2 (7%) with a combination of formats. Of the 30 tools, 24 (80%) mentioned a clear aim, including 7 (23%) that supported reflection or communication, 8 (27%) that supported people in making decisions, 7 (23%) that provided support to document decisions, and 2 (7%) that aimed to achieve all these aims. Of the 30 tools, 7 (23%) provided information on the development, all of which were developed in collaboration with health care professionals, and 3 (10%) with end users. Quality scores ranged between 11 and 28, with most of the lower-scoring tools not referring to information sources. Conclusions: A variety of ACP support tools are available on the web, varying in the quality of content. In the future, users should be involved in the development process of ACP support tools, and the content should be substantiated by scientific evidence. Trial Registration: PROSPERO CRD42020184112; https://tinyurl.com/mruf8b43 %M 35442207 %R 10.2196/33320 %U https://www.jmir.org/2022/4/e33320 %U https://doi.org/10.2196/33320 %U http://www.ncbi.nlm.nih.gov/pubmed/35442207 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e30138 %T Cannabis Use in Adults Who Screen Positive for Attention Deficit/Hyperactivity Disorder: CANreduce 2.0 Randomized Controlled Trial Subgroup Analysis %A Ahlers,Joachim %A Baumgartner,Christian %A Augsburger,Mareike %A Wenger,Andreas %A Malischnig,Doris %A Boumparis,Nikolaos %A Berger,Thomas %A Stark,Lars %A Ebert,David D %A Haug,Severin %A Schaub,Michael P %+ Swiss Research Institute for Public Health and Addiction, University of Zurich, Konradstrasse 32, Zurich, 8005, Switzerland, 41 444481160, joachim.ahlers@wisemed.ch %K attention deficit/hyperactivity disorder %K ADHD %K cannabis %K cannabis use disorder %K CANreduce %K web-based self-help tool %K online tool %K online health %K mental health %K digital health %K anxiety %K depression %D 2022 %7 20.4.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Prevalence rates for lifetime cannabis use and cannabis use disorder are much higher in people with attention deficit/hyperactivity disorder than in those without. CANreduce 2.0 is an intervention that is generally effective at reducing cannabis use in cannabis misusers. This self-guided web-based intervention (6-week duration) consists of modules grounded in motivational interviewing and cognitive behavioral therapy. Objective: We aimed to evaluate whether the CANreduce 2.0 intervention affects cannabis use patterns and symptom severity in adults who screen positive for attention deficit/hyperactivity disorder more than in those who do not. Methods: We performed a secondary analysis of data from a previous study with the inclusion criterion of cannabis use at least once weekly over the last 30 days. Adults with and without attention deficit/hyperactivity disorder (based on the Adult Attention deficit/hyperactivity disorder Self-Report screener) who were enrolled to the active intervention arms of CANreduce 2.0 were compared regarding the number of days cannabis was used in the preceding 30 days, the cannabis use disorder identification test score (CUDIT) and the severity of dependence scale score (SDS) at baseline and the 3-month follow-up. Secondary outcomes were Generalized Anxiety Disorder score, Center for Epidemiological Studies Depression scale score, retention, intervention adherence, and safety. Results: Both adults with (n=94) and without (n=273) positive attention-deficit/hyperactivity disorder screening reported significantly reduced frequency (reduction in consumption days: with: mean 11.53, SD 9.28, P<.001; without: mean 8.53, SD 9.4, P<.001) and severity of cannabis use (SDS: with: mean 3.57, SD 3.65, P<.001; without: mean 2.47, SD 3.39, P<.001; CUDIT: with: mean 6.38, SD 5.96, P<.001; without: mean 5.33, SD 6.05, P<.001), as well as anxiety (with: mean 4.31, SD 4.71, P<.001; without: mean 1.84, SD 4.22, P<.001) and depression (with: mean 10.25, SD 10.54; without: mean 4.39, SD 10.22, P<.001). Those who screened positive for attention deficit/hyperactivity disorder also reported significantly decreased attention deficit/hyperactivity disorder scores (mean 4.65, SD 4.44, P<.001). There were no significant differences in change in use (P=.08), dependence (P=.95), use disorder (P=.85), attention deficit/hyperactivity disorder status (P=.84), depression (P=.84), or anxiety (P=.26) between baseline and final follow-up, dependent on positive attention-deficit/hyperactivity disorder screening. Attention deficit/hyperactivity disorder symptom severity at baseline was not associated with reduced cannabis use frequency or severity but was linked to greater reductions in depression (Spearman ρ=.33) and anxiety (Spearman ρ=.28). Individuals with positive attention deficit/hyperactivity disorder screening were significantly less likely to fill out the consumption diary (P=.02), but the association between continuous attention deficit/hyperactivity disorder symptom severity and retention (Spearman ρ=−0.10, P=.13) was nonsignificant. There also was no significant intergroup difference in the number of completed modules (with: mean 2.10, SD 2.33; without: mean 2.36, SD 2.36, P=.34), and there was no association with attention deficit/hyperactivity disorder symptom severity (Spearman ρ=−0.09; P=.43). The same was true for the rate of adverse effects (P=.33). Conclusions: Cannabis users screening positive for attention deficit/hyperactivity disorder may benefit from CANreduce 2.0 to decrease the frequency and severity of cannabis dependence and attenuate symptoms of depression and attention deficit/hyperactivity disorder-related symptoms. This web-based program’s advantages include its accessibility for remote users and a personalized counselling option that may contribute to increased adherence and motivation to change among program users. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 11086185; http://www.isrctn.com/ISRCTN11086185 %M 35442196 %R 10.2196/30138 %U https://www.jmir.org/2022/4/e30138 %U https://doi.org/10.2196/30138 %U http://www.ncbi.nlm.nih.gov/pubmed/35442196 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e26339 %T From the United Kingdom to Australia—Adapting a Web-Based Self-management Education Program to Support the Management of Type 2 Diabetes: Tutorial %A Olson,Jenny %A Hadjiconstantinou,Michelle %A Luff,Carly %A Watts,Karen %A Watson,Natasha %A Miller,Venus %A Schofield,Deborah %A Khunti,Kamlesh %A Davies,Melanie J %A Calginari,Sara %+ Department of Kinesiology, The Pennsylvania State University, Recreation Hall, University Park, PA, 16801, United States, 1 8143083411, Jenny.Olson@psu.edu %K diabetes mellitus %K type 2 %K technology %K self-management %D 2022 %7 20.4.2022 %9 Tutorial %J J Med Internet Res %G English %X Diabetes self-management education and support can improve outcomes in people with diabetes. Providing health interventions via digital modes of delivery can extend the reach of programs delivered through traditional means. The web-based version of the Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (MyDESMOND) is a digital diabetes education and support program for people with type 2 diabetes. The program was originally developed in the United Kingdom and is evidence-based, grounded in behavioral theory, and designed through a rigorous process of intervention mapping. As such, MyDESMOND was considered an ideal candidate for adaptation to the Australian setting. Program content and the digital platform were modified to suit the local context to increase the likelihood that the revised version of MyDESMOND will deliver similar outcomes to the original program. The aim of this paper is to describe the systematic processes undertaken to adapt the digital MyDESMOND diabetes education and support program for people with type 2 diabetes to the Australian setting. The adaptation involved a multidisciplinary group with a diverse range of skills and expertise—a governance structure was established, a skilled project team was appointed, and stakeholder engagement was strategically planned. The adaptation of the program content included modifications to the clinical recommendations, the inclusion of local resources, practical changes, and revisions to optimize readability. A 2-stage independent review of the modified content was enacted. Digital adaptations were informed by relevant standards, local legislative requirements, and considerations of data sovereignty. The digital platform was extensively tested before deployment to the production setting. MyDESMOND is the first evidence-based digital diabetes education and support program for Australians with type 2 diabetes. This paper provides a road map for the adaptation of digital health interventions to new contexts. %M 35442198 %R 10.2196/26339 %U https://www.jmir.org/2022/4/e26339 %U https://doi.org/10.2196/26339 %U http://www.ncbi.nlm.nih.gov/pubmed/35442198 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e34312 %T Promoting Physical Activity in a Spanish-Speaking Latina Population of Low Socioeconomic Status With Chronic Neurological Disorders: Proof-of-Concept Study %A Garbin,Alexander %A Díaz,Jesús %A Bui,Vy %A Morrison,Janina %A Fisher,Beth E %A Palacios,Carina %A Estrada-Darley,Ingrid %A Haase,Danielle %A Wing,David %A Amezcua,Lilyana %A Jakowec,Michael W %A Kaplan,Charles %A Petzinger,Giselle %+ Physical Therapy Program, Department of Physical Medicine and Rehabilitation, University of Colorado Anschutz Medical Campus, Mail Stop C244, 13121 E 17th Ave, Room 310B, Aurora, CO, 80045, United States, 1 303 724 9590, alexander.garbin@cuanschutz.edu %K exercise %K quality of life %K motivation %K promotion %K community study %K clinical trial %D 2022 %7 20.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Physical activity (PA) is known to improve quality of life (QoL) as well as reduce mortality and disease progression in individuals with chronic neurological disorders. However, Latina women are less likely to participate in recommended levels of PA due to common socioeconomic barriers, including limited resources and access to exercise programs. Therefore, we developed a community-based intervention with activity monitoring and behavioral coaching to target these barriers and facilitate sustained participation in an exercise program promoting PA. Objective: The aim of this study was to determine the feasibility and efficacy of a community-based intervention to promote PA through self-monitoring via a Fitbit and behavioral coaching among Latina participants with chronic neurological disorders.  Methods: We conducted a proof-of-concept study among 21 Spanish-speaking Latina participants recruited from the Los Angeles County and University of Southern California (LAC+USC) neurology clinic; participants enrolled in the 16-week intervention at The Wellness Center at The Historic General Hospital in Los Angeles. Demographic data were assessed at baseline. Feasibility was defined by participant attrition and Fitbit adherence. PA promotion was determined by examining change in time spent performing moderate-to-vigorous PA (MVPA) over the 16-week period. The effect of behavioral coaching was assessed by quantifying the difference in MVPA on days when coaching occurred versus on days without coaching. Change in psychometric measures (baseline vs postintervention) and medical center visits (16 weeks preintervention vs during the intervention) were also examined. Results: Participants were of low socioeconomic status and acculturation. A total of 19 out of 21 (90%) participants completed the study (attrition 10%), with high Fitbit wear adherence (mean 90.31%, SD 10.12%). Time performing MVPA gradually increased by a mean of 0.16 (SD 0.23) minutes per day (P<.001), which was equivalent to an increase of approximately 18 minutes in MVPA over the course of the 16-week study period. Behavioral coaching enhanced intervention effectiveness as evidenced by a higher time spent on MVPA on days when coaching occurred via phone (37 min/day, P=.02) and in person (45.5 min/day, P=.01) relative to days without coaching (24 min/day). Participants improved their illness perception (effect size g=0.30) and self-rated QoL (effect size g=0.32). Additionally, a reduction in the number of medical center visits was observed (effect size r=0.44), and this reduction was associated with a positive change in step count during the study period (P.=04). Conclusions: Self-monitoring with behavioral coaching is a feasible community-based intervention for PA promotion among Latina women of low socioeconomic status with chronic neurological conditions. PA is known to be important for brain health in neurological conditions but remains relatively unexplored in minority populations. Trial Registration: ClinicalTrials.gov NCT04820153; https://clinicaltrials.gov/ct2/show/NCT04820153 %M 35442197 %R 10.2196/34312 %U https://formative.jmir.org/2022/4/e34312 %U https://doi.org/10.2196/34312 %U http://www.ncbi.nlm.nih.gov/pubmed/35442197 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e32960 %T Formative Provider Testing of a New Encounter Decision Aid for Smoking Cessation: Questionnaire Study %A Hollanda De Sa Neto,Herul %A Habfast-Robertson,Ines %A Hempel-Bruder,Christina %A Durand,Marie-Anne %A Jacot-Sadowski,Isabelle %A Khazaal,Yasser %A Berlin,Ivan %A Selby,Kevin %+ Center for Primary Care and Public Health (Unisanté), Rue de Bugnon 44, Lausanne, 1010, Switzerland, 41 79 556 67 53, kevin.selby@unisante.ch %K decision aid %K smoking cessation %K electronic tool %K shared decision-making %D 2022 %7 20.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Smoking cessation is an essential part of preventing and reducing the risk of smoking-associated morbidity and mortality. However, there is often little time to discuss smoking cessation in primary care. Decision aids (DAs) designed for clinic visits (encounter DAs) need to be clear, short, and concise to optimize therapeutic education, increase interaction, and improve the therapeutic alliance. Such a DA for smoking cessation could potentially improve counseling and increase the use of pharmacological treatments. Objective: We aimed to collect feedback on an electronic encounter DA that facilitates physician-patient interaction and shared decision-making for smoking cessation in primary care. Methods: We developed an electronic, encounter DA (howtoquit.ch) from a paper version created by our team in 2017 following user-centered design principles. The DA is a 1-page interactive website presenting and comparing medications for tobacco cessation and electronic cigarettes. Each smoking cessation medication has a drop down menu that presents additional information, a video demonstration, and prescribing information for physicians. To test the DA, we submitted a questionnaire to approximately 20 general practitioner residents of an academic general medicine department, 5 general practitioners, and 6 experts in the field of smoking cessation. The questionnaire consisted of 4 multiple-choice and 2 free-text questions assessing the usability or acceptability of the DA, the acquisition of new knowledge for practitioners, the perceived utility in supporting shared decision-making, perceived strengths and weaknesses, and whether the participants would recommend the tool to other clinicians. Results: In all, 6 residents, 3 general practitioners in private practice, and 2 tobacco cessation experts completed the questionnaire (N=11), with 4 additional experts providing open-text feedback. On the 11 questionnaires, the DA was rated as practical and intuitive (mean 4.6/5), and providers felt it supported shared decision-making (mean 4.4/5), as comparisons were readily possible. Inclusion of explanatory videos was seen as a bonus. Several changes were suggested, like grouping together similar medications and adding a landing page to briefly explain the site. Changes were implemented according to end-user comments. Conclusions: The overall assessment of the encounter DA by a group of physicians and experts was positive. The ultimate objective is to have the tool deployed and easily accessible for all to use. %M 35442200 %R 10.2196/32960 %U https://formative.jmir.org/2022/4/e32960 %U https://doi.org/10.2196/32960 %U http://www.ncbi.nlm.nih.gov/pubmed/35442200 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e33416 %T A Tailored Web-Based Video Intervention (ParentCoach) to Support Parents With Children With Sleeping Problems: User-Centered Design Approach %A Preuhs,Katharina %A van Keulen,Hilde %A Andree,Rosa %A Wins,Sophie %A van Empelen,Pepijn %+ Expertise Group Child Health, Netherlands Organization for Applied Scientific Research (TNO), Schipholweg 77, Leiden, 2316 ZL, Netherlands, 31 611700552, pepijn.vanempelen@tno.nl %K positive parenting %K usability testing %K lower health literacy %K user-centered design %K iterative development %K eHealth %K web-based intervention %K mobile health %K mHealth %K parenting %D 2022 %7 19.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Many parents frequently struggle with undesirable or problematic behavior (ie, temper tantrums and whining) displayed by their child. To support parents in promoting positive parenting skills (ie, recognizing challenging situations and reacting appropriately), the interactive video e-learning tool ParentCoach was developed. The tool aims to teach parents generic behavioral responses by means of situational learning, tailoring, and problem solving. The first demonstration focused on sleeping problems. Objective: The aim of this paper is to illustrate the user-centered development of ParentCoach. Methods: We conducted usability, understandability, and acceptance tests among the target group (29 parents, 7 youth health care professionals, and 4 individuals with former lower health literacy) in different phases of the development process via focus groups, interviews, and surveys. This allowed for relevant insights on specifications and user requirements to guide the development and revision of the tool in each iteration. Results: Iterative testing and development allowed for the final demonstration of ParentCoach to be experienced as a relevant and accessible parenting intervention that can be used as a stand-alone program or in combination with another program. Conclusions: This paper elaborates on the iterative development process and its benefits for the final demonstration of ParentCoach. %M 35438640 %R 10.2196/33416 %U https://formative.jmir.org/2022/4/e33416 %U https://doi.org/10.2196/33416 %U http://www.ncbi.nlm.nih.gov/pubmed/35438640 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 4 %P e37106 %T Investigating Why and How Young Adults Use Protective Behavioral Strategies for Alcohol and Marijuana Use: Protocol for Developing a Randomized Controlled Trial %A Lewis,Melissa A %A Litt,Dana M %A Fairlie,Anne M %A Kilmer,Jason R %A Kannard,Emma %A Resendiz,Raul %A Walker,Travis %+ Health Behavior and Health Systems, University of North Texas Health Science Center, 3500 Camp Bowie BLVD, Fort Worth, TX, 76107, United States, 1 817 735 5136, melissa.lewis@unthsc.edu %K alcohol use %K marijuana use %K protective behavioral strategies %K intervention development %K young adults %D 2022 %7 19.4.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Young adulthood is associated with increased alcohol and marijuana use compared with other developmental periods. Alcohol and marijuana use place individuals at high risk for acute and long-term negative consequences. Despite the relatively large cross-sectional and longitudinal literature on protective behavioral strategies (PBS; behaviors that individuals can use to limit consequences and reduce substance use), little is known about why young adults choose to use PBS on specific occasions or why they might use PBS differently across occasions (ie, quality and consistency). There is significant room for improvement in the conceptualization, application, and understanding of PBS. Objective: This study aims to develop a novel, brief web-based and SMS text messaging intervention, with input from young adults who use alcohol and marijuana, which addresses the extent to which motivations for PBS use and nonuse (marijuana or alcohol) and the quality of PBS use (the degree of effectiveness or degree of implementation) differ when using alcohol alone versus concurrently or simultaneously with marijuana. Methods: This research will be conducted in 2 phases. Phase 1 will involve web-based focus groups (N=100) and cognitive interviews (N=10) to determine why young adults (aged 18-24 years) use or do not use specific PBS related to alcohol and marijuana use and elicit feedback on how motivations and the quality of PBS could be incorporated into a web-based and SMS text messaging PBS intervention as well as elicit feedback on developed intervention material. In phase 2, young adults (N=200; aged 18-24 years), who typically use alcohol and marijuana for at least 2 days per week, will be randomized to either the intervention or waitlist control group. The intervention will be brief, web-based, focusing on self-selected alcohol and marijuana PBS messages and motives for using alcohol- and marijuana-related PBS, and including intervention content delivered via SMS text messages 3 days a week (random day, Friday, and Saturday) over 8 consecutive weeks. All participants will report on PBS use, motivations for PBS use (and nonuse), quality of PBS use, and alcohol and marijuana use in morning surveys timed to occur the day after the intervention SMS text messages for those in the intervention group. Results: Recruitment and enrollment for phase 1 began in January 2022. Recruitment for phase 2 is anticipated to begin in January 2023. Upon completion of the phase 2 pilot, we will examine the feasibility, acceptability, and preliminary effect sizes of the newly developed brief web-based and SMS text messaging intervention. Conclusions: This study will provide an in-depth understanding of young adults’ PBS use and has the potential to develop a more efficacious intervention for co-occurring or simultaneous alcohol and marijuana behaviors. Trial Registration: ClinicalTrials.gov NCT04978129; https://clinicaltrials.gov/ct2/show/NCT04978129 International Registered Report Identifier (IRRID): DERR1-10.2196/37106 %M 35438642 %R 10.2196/37106 %U https://www.researchprotocols.org/2022/4/e37106 %U https://doi.org/10.2196/37106 %U http://www.ncbi.nlm.nih.gov/pubmed/35438642 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e29380 %T Weight Loss Trajectories and Related Factors in a 16-Week Mobile Obesity Intervention Program: Retrospective Observational Study %A Kim,Ho Heon %A Kim,Youngin %A Michaelides,Andreas %A Park,Yu Rang %+ Department of Biomedical Systems Informatics, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea, 82 010 5240 3434, yurangpark@yuhs.ac %K clustering %K mobile health %K weight loss %K weight management %K behavior management %K time series analysis %K mHealth %K obesity %K outcomes %K machine learning %K mobile app %K adherence %K prediction %K mobile phone %D 2022 %7 15.4.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: In obesity management, whether patients lose ≥5% of their initial weight is a critical factor in clinical outcomes. However, evaluations that take only this approach are unable to identify and distinguish between individuals whose weight changes vary and those who steadily lose weight. Evaluation of weight loss considering the volatility of weight changes through a mobile-based intervention for obesity can facilitate understanding of an individual’s behavior and weight changes from a longitudinal perspective. Objective: The aim of this study is to use a machine learning approach to examine weight loss trajectories and explore factors related to behavioral and app use characteristics that induce weight loss. Methods: We used the lifelog data of 13,140 individuals enrolled in a 16-week obesity management program on the health care app Noom in the United States from August 8, 2013, to August 8, 2019. We performed k-means clustering with dynamic time warping to cluster the weight loss time series and inspected the quality of clusters with the total sum of distance within the clusters. To identify use factors determining clustering assignment, we longitudinally compared weekly use statistics with effect size on a weekly basis. Results: The initial average BMI value for the participants was 33.6 (SD 5.9) kg/m2, and it ultimately reached 31.6 (SD 5.7) kg/m2. Using the weight log data, we identified five clusters: cluster 1 (sharp decrease) showed the highest proportion of participants who reduced their weight by >5% (7296/11,295, 64.59%), followed by cluster 2 (moderate decrease). In each comparison between clusters 1 and 3 (yo-yo) and clusters 2 and 3, although the effect size of the difference in average meal record adherence and average weight record adherence was not significant in the first week, it peaked within the initial 8 weeks (Cohen d>0.35) and decreased after that. Conclusions: Using a machine learning approach and clustering shape-based time series similarities, we identified 5 weight loss trajectories in a mobile weight management app. Overall adherence and early adherence related to self-monitoring emerged as potential predictors of these trajectories. %M 35436211 %R 10.2196/29380 %U https://www.jmir.org/2022/4/e29380 %U https://doi.org/10.2196/29380 %U http://www.ncbi.nlm.nih.gov/pubmed/35436211 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e36721 %T An mHealth Self-management System for Support Children With Acute Lymphocytic Leukemia and Their Caregivers: Qualitative Co-design Study %A Mehdizadeh,Hamed %A Asadi,Farkhondeh %A Emami,Hassan %A Mehrvar,Azim %A Nazemi,Eslam %+ Health Information Technology and Management Department, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Qods Square, Darband St, Tehran, 1441663773, Iran, 98 21 2271 8531, asadifar@sbmu.ac.ir %K digital health %K eHealth %K mHealth %K mobile app %K smartphone %K mobile phone %K self-management %K patient education %K children %K caregivers %K acute lymphocytic leukemia %K user-centered design %D 2022 %7 15.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The unique features of smartphones have extended their use in different fields, especially in the health care domain. These features offer new opportunities to support patients with chronic conditions by providing them with information, education, and self-management skills. We developed a digital self-management system to support children with cancer and their caregivers in Iran (low- and middle-income country). Objective: This study is aimed at the development and preliminary evaluation of a cancer self-management system (CanSelfMan) tailored to the needs of children with cancer and their parents or caregivers. Methods: This study was conducted in collaboration with a multidisciplinary team between January and February 2020 at MAHAK’s Pediatric Cancer Treatment and Research Center. We developed a self-management system in six stages: requirement analysis, conformity assessment, preparation of educational content, app prototyping, preliminary evaluation, and developing the final version. Results: A total of 35 people (n=24, 69% parents and n=11, 31% children) volunteered to participate in the study. However, only 63% (15/24) of parents and 73% (8/11) of children were eligible to participate. By adopting a user-centered design approach, we developed a mobile app, CanSelfMan, that includes five main modules (knowledge base, self-management tips, self-assessment report, ask a question, and reminders) that provide access to reliable information about acute lymphocytic leukemia and the self-management skills required for side effect measurement and reporting. A web-based dashboard was also developed for oncologists and included a dashboard to monitor users’ symptoms and answer their questions. Conclusions: The CanSelfMan app can support these groups by providing access to reliable information about cancer, facilitating communication between children or parents and health care providers, and helping promote medication adherence through a reminder function. The active participation of the target group can help identify their needs. Therefore, through the involvement of stakeholders such as patients, caregivers, and oncologists in the design process, we improved usability and ensured that the final product was useful. This app is now ready to proceed with feasibility studies. %M 35228195 %R 10.2196/36721 %U https://formative.jmir.org/2022/4/e36721 %U https://doi.org/10.2196/36721 %U http://www.ncbi.nlm.nih.gov/pubmed/35228195 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e35614 %T Evaluation of the Immediate Effects of Web-Based Intervention Modules for Goals, Planning, and Coping Planning on Physical Activity: Secondary Analysis of a Randomized Controlled Trial on Weight Loss Maintenance %A Mattila,Elina %A Horgan,Graham %A Palmeira,António L %A O'Driscoll,Ruairi %A Stubbs,R James %A Heitmann,Berit L %A Marques,Marta M %+ VTT Technical Research Centre of Finland Ltd, Visiokatu 4, Tampere, 33720, Finland, 358 407162230, elina.m.mattila@vtt.fi %K digital intervention %K Fitbit %K weight %K weight loss maintenance %K physical activity %K fitness %K exercise %K goal setting %K action planning %K coping planning %K control trial %K secondary analysis %K RCT %K randomized controlled trial %K long-term effect %K short-term effect %K immediate effect %K sustained effect %D 2022 %7 14.4.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The use of digital interventions can be accurately monitored via log files. However, monitoring engagement with intervention goals or enactment of the actual behaviors targeted by the intervention is more difficult and is usually evaluated based on pre-post measurements in a controlled trial. Objective: The objective of this paper is to evaluate if engaging with 2 digital intervention modules focusing on (1) physical activity goals and action plans and (2) coping with barriers has immediate effects on the actual physical activity behavior. Methods: The NoHoW Toolkit (TK), a digital intervention developed to support long-term weight loss maintenance, was evaluated in a 2 x 2 factorial randomized controlled trial. The TK contained various modules based on behavioral self-regulation and motivation theories, as well as contextual emotion regulation approaches, and involved continuous tracking of weight and physical activity through connected commercial devices (Fitbit Aria and Charge 2). Of the 4 trial arms, 2 had access to 2 modules directly targeting physical activity: a module for goal setting and action planning (Goal) and a module for identifying barriers and coping planning (Barriers). Module visits and completion were determined based on TK log files and time spent in the module web page. Seven physical activity metrics (steps; activity; energy expenditure; fairly active, very active and total active minutes; and distance) were compared before and after visiting and completing the modules to examine whether the modules had immediate or sustained effects on physical activity. Immediate effect was determined based on 7-day windows before and after the visit, and sustained effects were evaluated for 1 to 8 weeks after module completion. Results: Out of the 811 participants, 498 (61.4%) visited the Goal module and 406 (50.1%) visited the Barriers module. The Barriers module had an immediate effect on very active and total active minutes (very active minutes: before median 24.2, IQR 10.4-43.0 vs after median 24.9, IQR 10.0-46.3; P=.047; total active minutes: before median 45.1, IQR 22.9-74.9 vs after median 46.9, IQR 22.4-78.4; P=.03). The differences were larger when only completed Barriers modules were considered. The Barriers module completion was also associated with sustained effects in fairly active and total active minutes for most of the 8 weeks following module completion and for 3 weeks in very active minutes. Conclusions: The Barriers module had small, significant, immediate, and sustained effects on active minutes measured by a wrist-worn activity tracker. Future interventions should pay attention to assessing barriers and planning coping mechanisms to overcome them. Trial Registration: ISRCTN Registry ISRCTN88405328; https://www.isrctn.com/ISRCTN88405328 %M 35436232 %R 10.2196/35614 %U https://www.jmir.org/2022/4/e35614 %U https://doi.org/10.2196/35614 %U http://www.ncbi.nlm.nih.gov/pubmed/35436232 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e31889 %T Social Media–Based Interventions for Health Behavior Change in Low- and Middle-Income Countries: Systematic Review %A Seiler,Jessie %A Libby,Tanya E %A Jackson,Emahlea %A Lingappa,JR %A Evans,WD %+ Department of Epidemiology, University of Washington, 3980 15th Ave NE, Seattle, WA, 98195, United States, 1 206 543 1065, jseiler@uw.edu %K social media %K behavior change %K low- and middle-income countries %K mobile phone %D 2022 %7 14.4.2022 %9 Review %J J Med Internet Res %G English %X Background: Despite the wealth of evidence regarding effective health behavior change techniques using digital interventions to focus on residents of high-income countries, there is limited information of a similar nature for low- and middle-income countries. Objective: The aim of this review is to identify and describe the available literature on effective social media–based behavior change interventions within low- and middle-income countries. Methods: This systematic review was conducted in accordance with the 2009 PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. We searched PubMed, Embase, Elsevier, CINAHL, PsycInfo, and Global Index Medicus, and the final search was conducted on April 6, 2021. We excluded studies published before 2000 because of the subject matter. We included studies that evaluated interventions conducted at least partly on a social media platform. Results: We identified 1832 studies, of which 108 (5.89%) passed title-abstract review and were evaluated by full-text review. In all, 30.6% (33/108) were included in the final analysis. Although 22 studies concluded that the social media intervention was effective, only 13 quantified the level of social media engagement, of which, few used theory (n=8) or a conceptual model (n=5) of behavior change. Conclusions: We identified gaps in the settings of interventions, types and sectors of interventions, length of follow-up, evaluation techniques, use of theoretical and conceptual models, and discussions of the privacy implications of social media use. Trial Registration: PROSPERO CRD42020223572; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=223572 %M 35436220 %R 10.2196/31889 %U https://www.jmir.org/2022/4/e31889 %U https://doi.org/10.2196/31889 %U http://www.ncbi.nlm.nih.gov/pubmed/35436220 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 2 %P e32628 %T Process and Information Needs When Searching for and Selecting Apps for Smoking Cessation: Qualitative Study Using Contextual Inquiry %A Hendriks,Ylva %A Peek,Sebastiaan %A Kaptein,Maurits %A Bongers,Inge %+ Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, PO Box 90153, Tilburg, 5000 LE, Netherlands, 31 13 466 4892, ylva.hendriks@tilburguniversity.edu %K mHealth and eHealth %K contextual inquiry %K decision-making %K mobile app search and selection %K apps for smoking cessation %K mobile apps %K mobile phone %D 2022 %7 14.4.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Hundreds of apps are available to support people in their quest to quit smoking. It has been hypothesized that selecting an app from a sizable volume without any aid can be overwhelming and difficult. However, little is known about how people choose apps for smoking cessation and what exactly people want to know about an app before choosing to install it. Understanding the decision-making process may ultimately be helpful in creating tools to help people meaningfully select apps. Objective: The aim of this study is to obtain insights into the process of searching and selecting mobile apps for smoking cessation and map the range of actions and the accompanying reasons during the search, focusing on the information needs and experiences of those who aim to find an app. Methods: Contextual inquiries were conducted with 10 Dutch adults wanting to quit smoking by using an app. During the inquiries, we observed people as they chose an app. In addition, 2 weeks later, there was a short semistructured follow-up interview over the phone. Through convenience and purposive sampling, we included participants differing in gender, age, and educational level. We used thematic analysis to analyze the transcribed interviews and leveraged a combination of video and audio recordings to understand what is involved in searching and selecting apps for smoking cessation. Results: The process of finding smoking cessation apps is comprehensive: participants explored, evaluated, and searched for information; imagined using functions; compared apps; assessed the trustworthiness of apps and information; and made several decisions while navigating the internet and app stores. During the search, the participants gained knowledge of apps and developed clearer ideas about their wishes and requirements. Confidence and trust in these apps to help quitting remained quite low or even decreased. Although the process was predominantly a positive experience, the whole process took time and energy and caused negative emotions such as frustration and disappointment for some participants. In addition, without the participants realizing it, errors in information processing occurred, which affected the choices they made. All participants chose an app with the explicit intention of using it. After 2 weeks, of the 10 participants, 6 had used the app, of whom only 1 extensively. Conclusions: Finding an app in the current app stores that contains functions and features expected to help in quitting smoking takes considerable time and energy, can be a negative experience, and is prone to errors in information processing that affect decision-making. Therefore, we advise the further development of decision aids, such as advanced filters, recommender systems and curated health app portals, and make a number of concrete recommendations for the design of such systems. %M 35436217 %R 10.2196/32628 %U https://humanfactors.jmir.org/2022/2/e32628 %U https://doi.org/10.2196/32628 %U http://www.ncbi.nlm.nih.gov/pubmed/35436217 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e26438 %T Single-Session, Internet-Based Cognitive Behavioral Therapy to Improve Parenting Skills to Help Children Cope With Anxiety During the COVID-19 Pandemic: Feasibility Study %A Korpilahti-Leino,Tarja %A Luntamo,Terhi %A Ristkari,Terja %A Hinkka-Yli-Salomäki,Susanna %A Pulkki-Råback,Laura %A Waris,Otto %A Matinolli,Hanna-Maria %A Sinokki,Atte %A Mori,Yuko %A Fukaya,Mami %A Yamada,Yuko %A Sourander,Andre %+ Research Centre for Child Psychiatry, Department of Clinical Medicine, Faculty of Medicine, University of Turku, Lemminkäisenkatu 3, Turku, 20520, Finland, 358 50 365 3447, andre.sourander@utu.fi %K adolescent %K anxiety %K child %K cognitive behavioral therapy %K coping %K COVID-19 %K Internet %K mental health %K parents %K web-based %D 2022 %7 13.4.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The COVID-19 pandemic has had a major impact on families’ daily routines and psychosocial well-being, and technology has played a key role in providing socially distanced health care services. Objective: The first objective of this paper was to describe the content and delivery of a single-session, internet-based cognitive behavioral therapy (iCBT) intervention, which has been developed to help parents cope with children’s anxiety and manage daily situations with their children. The second objective was to report user adherence and satisfaction among the first participants who completed the intervention. Methods: The Let’s Cope Together intervention has been developed by our research group. It combines evidence-based CBT elements, such as psychoeducation and skills to manage anxiety, with parent training programs that strengthen how parents interact with their child and handle daily situations. A pre-post design was used to examine user satisfaction and the skills the parents learned. Participants were recruited using advertisements, media activity, day care centers, and schools and asked about background characteristics, emotional symptoms, and parenting practices before they underwent the iCBT. After they completed the 7 themes, they were asked what new parenting skills they had learned from the iCBT and how satisfied they were with the program. Results: Of the 602 participants who filled in the baseline survey, 196 (32.6%) completed the program’s 7 themes, and 189 (31.4%) completed the postintervention survey. Most (138/189, 73.0%) of the participants who completed the postintervention survey were satisfied with the program and had learned skills that eased both their anxiety (141/189, 74.6%) and their children’s anxiety (157/189, 83.1%). The majority (157/189, 83.1%) reported that they learned how to organize their daily routines better, and just over one-half (100/189, 53.0%) reported that the program improved how they planned each day with their children. Conclusions: The single-session iCBT helped parents to face the psychological demands of the COVID-19 pandemic. Future studies should determine how the participation rate and adherence can be optimized in digital, universal interventions. This will help to determine what kinds of programs should be developed, including their content and delivery. %M 35138265 %R 10.2196/26438 %U https://www.jmir.org/2022/4/e26438 %U https://doi.org/10.2196/26438 %U http://www.ncbi.nlm.nih.gov/pubmed/35138265 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 4 %P e33473 %T Web-Based Single Session Intervention for Perceived Control Over Anxiety During COVID-19: Randomized Controlled Trial %A Mullarkey,Michael %A Dobias,Mallory %A Sung,Jenna %A Ahuvia,Isaac %A Shumake,Jason %A Beevers,Christopher %A Schleider,Jessica %+ Department of Psychology, Stony Brook University, 100 Nicolls Rd, Stony Brook, NY, 11794, United States, 1 6316326000, Michael.Mullarkey@stonybrook.edu %K anxiety %K COVID-19 %K single-session intervention %K SSI %K perceived control %K intervention %K mental health %K control %K online intervention %K telemedicine %K telehealth %K scalable %D 2022 %7 12.4.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Anxiety is rising across the United States during the COVID-19 pandemic, and social distancing mandates preclude in-person mental health care. Greater perceived control over anxiety has predicted decreased anxiety pathology, including adaptive responses to uncontrollable stressors. Evidence suggests that no-therapist, single-session interventions can strengthen perceived control over emotions like anxiety; similar programs, if designed for the COVID-19 context, could hold substantial public health value. Objective: Our registered report evaluated a no-therapist, single-session, online intervention targeting perceived control over anxiety in the COVID-19 context against a placebo intervention encouraging handwashing. We tested whether the intervention could (1) decrease generalized anxiety and increase perceived control over anxiety and (2) achieve this without decreasing social-distancing intentions. Methods: We tested these questions using a between-subjects design in a weighted-probability sample of US adults recruited via a closed online platform (ie, Prolific). All outcomes were indexed via online self-report questionnaires. Results: Of 522 randomized individuals, 500 (95.8%) completed the baseline survey and intervention. Intent-to-treat analyses using all randomized participants (N=522) found no support for therapeutic or iatrogenic effects; effects on generalized anxiety were d=–0.06 (95% CI –0.27 to 0.15; P=.48), effects on perceived control were d=0.04 (95% CI –0.08 to 0.16; P=.48), and effects on social-distancing intentions were d=–0.02 (95% CI –0.23 to 0.19; P=.83). Conclusions: Strengths of this study included a large, nationally representative sample and adherence to open science practices. Implications for scalable interventions, including the challenge of targeting perceived control over anxiety, are discussed. Trial Registration: ClinicalTrials.gov NCT04459455; https://clinicaltrials.gov/show/NCT04459455 %M 35230962 %R 10.2196/33473 %U https://mental.jmir.org/2022/4/e33473 %U https://doi.org/10.2196/33473 %U http://www.ncbi.nlm.nih.gov/pubmed/35230962 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e29842 %T Computerized Cognitive Behavioral Therapy for Treatment of Depression and Anxiety in Adolescents: Systematic Review and Meta-analysis %A Wickersham,Alice %A Barack,Tamara %A Cross,Lauren %A Downs,Johnny %+ Institute of Psychiatry, Psychology & Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, United Kingdom, 44 (0)20 7848 0002, alice.wickersham@kcl.ac.uk %K adolescent %K anxiety %K depression %K meta-analysis %D 2022 %7 11.4.2022 %9 Review %J J Med Internet Res %G English %X Background: Depression and anxiety are major public health concerns among adolescents. Computerized cognitive behavioral therapy (cCBT) has emerged as a potential intervention, but its efficacy in adolescents remains unestablished. Objective: This review aimed to systematically review and meta-analyze findings on the efficacy of cCBT for the treatment of adolescent depression and anxiety. Methods: Embase, PsycINFO, and Ovid MEDLINE were systematically searched for randomized controlled trials in English, which investigated the efficacy of cCBT for reducing self-reported depression or anxiety in adolescents aged 11 to 19 years. Titles, abstracts, and full texts were screened for eligibility by 2 independent researchers (TB and LC). A random-effects meta-analysis was conducted to pool the effects of cCBT on depression and anxiety symptom scores compared with the control groups. Study quality was assessed using the Cochrane Collaboration Risk of Bias tool. Results: A total of 16 randomized controlled trials were eligible for inclusion in this review, of which 13 (81%) were included in the meta-analysis. The quality of the studies was mixed, with 5 (31%) studies rated as good overall, 2 (13%) rated as fair, and 9 (56%) rated as poor. Small but statistically significant effects of cCBT were detected, with cCBT conditions showing lower symptom scores at follow-up compared with control conditions for both anxiety (standardized mean difference −0.21, 95% CI −0.33 to −0.09; I2=36.2%) and depression (standardized mean difference −0.23, 95% CI −0.39 to −0.07; I2=59.5%). Secondary analyses suggested that cCBT may be comparable with alternative, active interventions (such as face-to-face therapy or treatment as usual). Conclusions: This meta-analysis reinforces the efficacy of cCBT for the treatment of anxiety and depression and is the first to examine this exclusively in adolescents. Future research could aim to identify the active components of these interventions toward optimizing their development and increasing the feasibility and acceptability of cCBT in this age group. Trial Registration: PROSPERO CRD42019141941; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=141941 %M 35404263 %R 10.2196/29842 %U https://www.jmir.org/2022/4/e29842 %U https://doi.org/10.2196/29842 %U http://www.ncbi.nlm.nih.gov/pubmed/35404263 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e28504 %T Association Between Mobile App Use and Caregivers’ Support System, Time Spent on Caregiving, and Perceived Well-being: Survey Study From a Large Employer %A Ozluk,Pelin %A Cobb,Rebecca %A Hoots,Alyson %A Sylwestrzak,Malgorzata %+ HealthCore Inc, 123 Justison Street Suite 200, Wilmington, DE, 19801, United States, 1 302 230 2023, pozluk@healthcore.com %K caregiving %K mobile app %K mobile phone %D 2022 %7 11.4.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Mobile technology to address caregiver needs has been on the rise. There is limited evidence of effectiveness of such technologies on caregiver experiences. Objective: This study evaluates the effectiveness of ianacare, a mobile app, among employees of a large employer. ianacare mobilizes personal social circles to help with everyday tasks. Through the use of ianacare, we evaluate the associations between coordinating caregiving tasks among a caregiver’s personal support network and outcomes related to the caregiver’s support system, time use, perceived productivity, and perceived health and well-being. Caregiver tasks include tasks such as meal preparation, respite care, pet care, and transportation. Time use is the measure of a caregiver’s time spent on caregiving tasks and how much time they had to take off from work to attend planned or unplanned caregiving tasks. Methods: We conducted 2 surveys to assess within-participant changes in outcomes for the unpaid, employed, caregivers after 6 weeks of using the mobile app (n=176) between March 30, 2020, and May 11, 2020. The surveys contained questions in three domains: the caregiver’s support system, time use and perceived productivity, and perceived health and well-being. The results of the linear probability models are presented below. Results: App use was significantly associated with decreasing the probability of doing most caregiving tasks alone by 9.1% points (SE 0.04; P=.01) and increasing the probability of at least one person helping the primary caregiver by 8.0% points (SE 0.035; P=.02). App use was also associated with improving the time use of the primary caregiver who took significantly less time off work to attend to caregiving duties by 12.5% points (SE 0.04; P=.003) and decreased the probability of spending more than 30 hours weekly on caregiving by 9.1% points (SE 0.04; P=.02). Additional findings on the positive impact of the app included a decrease in the probability of reporting feeling overwhelmed by caregiving tasks by 12.5% points (SE 0.04; P=.003) and a decrease in the probability of reporting negative health effects by 6.8% points (SE 0.04; P=.07) because of caregiving. Although subjects reported that COVID-19 increased their stress attributed to caregiving and prevented them from requesting help for some caregiving tasks, using the app was still associated with improvements in receiving help and lessening of the negative effects of caregiving on the caregivers. Conclusions: App use was associated with improvements in 7 of 11 caregiver outcomes across three main categories: their support system, time spent on caregiving, and perceived health and well-being. These findings provide encouraging evidence that the mobile app can significantly reduce caregiver burden by leveraging a caregiver’s support network despite the additional challenges brought by COVID-19 on caregivers. %M 35404266 %R 10.2196/28504 %U https://www.jmir.org/2022/4/e28504 %U https://doi.org/10.2196/28504 %U http://www.ncbi.nlm.nih.gov/pubmed/35404266 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e35554 %T Effectiveness of Digital Interventions for Preventing Alcohol Consumption in Pregnancy: Systematic Review and Meta-analysis %A Oh,Sarah Soyeon %A Moon,Jong Youn %A Chon,Doukyoung %A Mita,Carol %A Lawrence,Jourdyn A %A Park,Eun-Cheol %A Kawachi,Ichiro %+ Department of Preventive Medicine, Gachon University College of Medicine, 191 Hambangmoe-ro, Yeonsu-gu, Incheon, 21936, Republic of Korea, 82 8572647167, moonjy@gachon.ac.kr %K fetal alcohol spectrum disorders %K fetal alcohol syndrome %K digital health %K pregnancy %K alcohol consumption %K text message %K text messaging %K alcohol %K digital intervention %K mother %K systematic review %K meta-analysis %K mobile health %K mHealth %K computer-based intervention %K internet-based intervention %D 2022 %7 11.4.2022 %9 Review %J J Med Internet Res %G English %X Background: Alcohol consumption in pregnancy has been associated with serious fetal health risks and maternal complications. While previous systematic reviews of digital interventions during pregnancy have targeted smoking cessation and flu vaccine uptake, few studies have sought to evaluate their effectiveness in preventing alcohol consumption during pregnancy. Objective: This systematic review aims to assess (1) whether digital interventions are effective in preventing alcohol consumption during the pregnancy/pregnancy-planning period, and (2) the differential effectiveness of alternative digital intervention platforms (ie, computers, mobiles, and text messaging services). Methods: PubMed, Embase, CINAHL, and Web of Science were searched for studies with digital interventions aiming to prevent alcohol consumption among pregnant women or women planning to become pregnant. A random effects primary meta-analysis was conducted to estimate the combined effect size and extent to which different digital platforms were successful in preventing alcohol consumption in pregnancy. Results: Six studies were identified and included in the final review. The primary meta-analysis produced a sample-weighted odds ratio (OR) of 0.62 (95% CI 0.42-0.91; P=.02) in favor of digital interventions decreasing the risk of alcohol consumption during pregnancy when compared to controls. Computer/internet-based interventions (OR 0.59, 95% CI 0.38-0.93) were an effective platform for preventing alcohol consumption. Too few studies of text messaging (OR 0.29, 95% CI 0.29-2.52) were available to draw a conclusion. Conclusions: Overall, our review highlights the potential for digital interventions to prevent alcohol consumption among pregnant women and women planning to become pregnant. Considering the advantages of digital interventions in promoting healthy behavioral changes, future research is necessary to understand how certain platforms may increase user engagement and intervention effectiveness to prevent women from consuming alcohol during their pregnancies. %M 35404257 %R 10.2196/35554 %U https://www.jmir.org/2022/4/e35554 %U https://doi.org/10.2196/35554 %U http://www.ncbi.nlm.nih.gov/pubmed/35404257 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 2 %P e35641 %T Understanding the Potential of Mental Health Apps to Address Mental Health Needs of the Deaf and Hard of Hearing Community: Mixed Methods Study %A Borghouts,Judith %A Neary,Martha %A Palomares,Kristina %A De Leon,Cinthia %A Schueller,Stephen M %A Schneider,Margaret %A Stadnick,Nicole %A Mukamel,Dana B %A Sorkin,Dara H %A Brown,Dakota %A McCleerey-Hooper,Shannon %A Moriarty,Gloria %A Eikey,Elizabeth V %+ Department of Medicine, University of California, Irvine, 100 Theory, Irvine, CA, 92617, United States, 1 9498240246, jborghou@uci.edu %K mental health %K deaf and hard of hearing community %K mHealth %K digital health %K needs assessment %K deaf %K hard of hearing %K hearing %K focus group %K survey %K mixed methods %K intervention %K health app %K user needs %D 2022 %7 11.4.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Mental health concerns are a significant issue among the deaf and hard of hearing (D/HH) community, but community members can face several unique challenges to accessing appropriate resources. Objective: The aim of this study was to investigate the mental health needs of the D/HH community and how mental health apps may be able to support these needs. Methods: A total of 10 members of the D/HH community participated in a focus group and survey to provide their perspectives and experiences. Participants were members of the Center on Deafness Inland Empire team, which comprises people with lived experience as members of and advocates for the D/HH community. Results: Findings identified a spectrum of needs for mental health apps, including offering American Sign Language and English support, increased education of mental health to reduce stigma around mental health, direct communication with a Deaf worker, and apps that are accessible to a range of community members in terms of culture, resources required, and location. Conclusions: These findings can inform the development of digital mental health resources and outreach strategies that are appropriate for the D/HH community. %M 35404259 %R 10.2196/35641 %U https://humanfactors.jmir.org/2022/2/e35641 %U https://doi.org/10.2196/35641 %U http://www.ncbi.nlm.nih.gov/pubmed/35404259 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e33974 %T Use and Effect of Embodied Conversational Agents for Improving Eating Behavior and Decreasing Loneliness Among Community-Dwelling Older Adults: Randomized Controlled Trial %A Kramer,Lean L %A van Velsen,Lex %A Clark,Jenna L %A Mulder,Bob C %A de Vet,Emely %+ Consumption and Healthy Lifestyles, Wageningen University & Research, Hollandseweg 1, Wageningen, 6706 KN, Netherlands, 31 623412092, lean.kramer@wur.nl %K eHealth %K online intervention %K embodied conversational agent %K lifestyle change %K older adult %K user experience %K eating habits %K eating behavior %D 2022 %7 11.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Embodied conversational agents (ECAs) have been proposed as a promising interaction modality for the delivery of programs focused on promoting lifestyle changes. However, it is not understood what factors influence the health effects of ECAs or their use. Objective: We aimed to (1) identify whether ECAs could persuade community-dwelling older adults to change their dietary behavior and whether ECA use could decrease loneliness, (2) test the pathways to these effects, and (3) understand factors influencing the use of ECAs. Methods: A randomized controlled trial was conducted. The intervention group received access to the PACO service for 8 weeks. The waitlist group started PACO use after waiting for 4 weeks. Two primary outcomes (eating behavior and loneliness) were assessed via online questionnaires at intake, upon joining the waitlist, after 4 weeks, and after 8 weeks. The third primary outcome (use) was assessed via data logs. Secondary outcomes were measured at the same time points, via questionnaires or an optional interview. Results: In total, 32 participants completed the intervention. We found a significant correlation between use in minutes on the one hand, and perceived usefulness (r=0.39, P=.03) and enjoyment on the other (r=0.38, P=.03). However, these did not predict use in the full regression model (F2,29=1.98, P=.16, R2=0.12). Additionally, PACO use did not lead to improvement in eating behavior (χ22=0.34, P=.85) or a decrease in loneliness (χ22=0.02, P=.99). Conclusions: Our study did not provide any concluding evidence about factors that are linked to the use or health effects of ECAs. Future service design could benefit from either creating a functional design catering to the predominant stage in the precaution adoption process model of the targeted population, or by personalizing the service based on an intake in which the end user’s stage is determined. Trial Registration: ClinicalTrials.gov NCT04510883; https://clinicaltrials.gov/ct2/show/NCT04510883 International Registered Report Identifier (IRRID): RR2-10.2196/22186 %M 35404255 %R 10.2196/33974 %U https://formative.jmir.org/2022/4/e33974 %U https://doi.org/10.2196/33974 %U http://www.ncbi.nlm.nih.gov/pubmed/35404255 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 5 %N 2 %P e26760 %T Improved Digital Therapy for Developmental Pediatrics Using Domain-Specific Artificial Intelligence: Machine Learning Study %A Washington,Peter %A Kalantarian,Haik %A Kent,John %A Husic,Arman %A Kline,Aaron %A Leblanc,Emilie %A Hou,Cathy %A Mutlu,Onur Cezmi %A Dunlap,Kaitlyn %A Penev,Yordan %A Varma,Maya %A Stockham,Nate Tyler %A Chrisman,Brianna %A Paskov,Kelley %A Sun,Min Woo %A Jung,Jae-Yoon %A Voss,Catalin %A Haber,Nick %A Wall,Dennis Paul %+ Departments of Pediatrics (Systems Medicine) and Biomedical Data Science, Stanford University, Stanford, CA, United States, 1 5126800926, peterwashington@stanford.edu %K computer vision %K emotion recognition %K affective computing %K autism spectrum disorder %K pediatrics %K mobile health %K digital therapy %K convolutional neural network %K machine learning %K artificial intelligence %D 2022 %7 8.4.2022 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Automated emotion classification could aid those who struggle to recognize emotions, including children with developmental behavioral conditions such as autism. However, most computer vision emotion recognition models are trained on adult emotion and therefore underperform when applied to child faces. Objective: We designed a strategy to gamify the collection and labeling of child emotion–enriched images to boost the performance of automatic child emotion recognition models to a level closer to what will be needed for digital health care approaches. Methods: We leveraged our prototype therapeutic smartphone game, GuessWhat, which was designed in large part for children with developmental and behavioral conditions, to gamify the secure collection of video data of children expressing a variety of emotions prompted by the game. Independently, we created a secure web interface to gamify the human labeling effort, called HollywoodSquares, tailored for use by any qualified labeler. We gathered and labeled 2155 videos, 39,968 emotion frames, and 106,001 labels on all images. With this drastically expanded pediatric emotion–centric database (>30 times larger than existing public pediatric emotion data sets), we trained a convolutional neural network (CNN) computer vision classifier of happy, sad, surprised, fearful, angry, disgust, and neutral expressions evoked by children. Results: The classifier achieved a 66.9% balanced accuracy and 67.4% F1-score on the entirety of the Child Affective Facial Expression (CAFE) as well as a 79.1% balanced accuracy and 78% F1-score on CAFE Subset A, a subset containing at least 60% human agreement on emotions labels. This performance is at least 10% higher than all previously developed classifiers evaluated against CAFE, the best of which reached a 56% balanced accuracy even when combining “anger” and “disgust” into a single class. Conclusions: This work validates that mobile games designed for pediatric therapies can generate high volumes of domain-relevant data sets to train state-of-the-art classifiers to perform tasks helpful to precision health efforts. %M 35394438 %R 10.2196/26760 %U https://pediatrics.jmir.org/2022/2/e26760 %U https://doi.org/10.2196/26760 %U http://www.ncbi.nlm.nih.gov/pubmed/35394438 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e30877 %T Prioritizing Support Offered to Caregivers by Examining the Status Quo and Opportunities for Enhancement When Using Web-Based Self-reported Health Questionnaires: Descriptive Qualitative Study %A Coles,Theresa %A Lucas,Nicole %A Daniell,Erin %A Sullivan,Caitlin %A Wang,Ke %A Olsen,Jennifer M %A Shepherd-Banigan,Megan %+ Department of Population Health Sciences, Duke University, 215 Morris St, Durham, NC, 27701, United States, 1 919 613 7994, theresa.coles@duke.edu %K caregiver %K web-based questionnaires %K self-report questionnaires %K caregiver outcomes %K intervention technology %K patient-reported outcome measures %D 2022 %7 8.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The Rosalynn Carter Institute for Caregivers (RCI) offers evidence-based interventions to promote caregivers’ health and well-being. Trained coaches regularly meet with caregivers to offer education and instructions to improve caregiver health, build skill sets, and increase resilience. Two of these interventions, RCI Resources for Enhancing Alzheimer's Caregiver Health (REACH) and Operation Family Caregiver (OFC), use a set of caregiver-reported questionnaires to monitor caregivers’ health status and needs. Objective: This study aims to describe how web-based assessment questionnaires are used to identify and monitor caregiver status in the RCI REACH and OFC programs and outlines perceived enhancements to the web-based system that could support caregiver-coach encounters by directing priorities. Methods: This was a descriptive, qualitative study. Data were collected via semistructured interviews with caregivers and coaches in the RCI REACH and OFC programs from July 2020 to October 2020. During the interviews, participants were asked to describe how the assessment questionnaires were used to inform caregiver-coach encounters, perceived usefulness of enhancements to web-based display, and preference for the structure of score results. The interviews were recorded, transcribed, and coded using structural and interpretive codes from a structured codebook. Qualitative content analysis was used to identify themes and summarize the results. Results: A total of 25 caregivers (RCI REACH: 13/25, 52%; OFC: 12/25, 48%) and 11 coaches (RCI REACH: 5/11, 45%; OFC: 6/11, 55%) were interviewed. Most caregivers indicated that the assessment questions were relevant to their caregiving experience. Some caregivers and coaches indicated that they thought the assessment should be administered multiple times throughout the program to evaluate the caregiver progress. Overall, caregivers did not want their scores to be compared with those of other caregivers, and there was heterogeneity in how caregivers preferred to view their results at the question or topic level. Coaches were uncertain as to which and how much of the results from the self-reported questionnaires should be shared with caregivers. Overall, the results were very similar, regardless of program affiliation (RCI REACH vs OFC). Conclusions: Web-based and procedural enhancements were identified to enrich caregiver-coach encounters. New and enhanced strategies for using web-based assessment questionnaires to direct priorities in the caregiver-coach encounters included integrating figures showing caregiver progress at the individual caregiver level, ability to toggle results through different figures focused on individual versus aggregate results, and support for interpreting scores. The results of this qualitative study will drive the next steps for RCI’s web-based platform and expand on current standards for administering self-reported questionnaires in clinical practice settings. %M 35394436 %R 10.2196/30877 %U https://formative.jmir.org/2022/4/e30877 %U https://doi.org/10.2196/30877 %U http://www.ncbi.nlm.nih.gov/pubmed/35394436 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e16141 %T Effectiveness of a Pharmacist-Led Web-Based Medication Adherence Tool With Patient-Centered Communication: Results of a Clustered Randomized Controlled Trial %A van Lieshout,Jan %A Lacroix,Joyca %A van Halteren,Aart %A Teichert,Martina %+ Scientific Center for Quality of Healthcare (IQ healthcare), Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, Nijmegen, 6500HB, Netherlands, 31 024 361 53 05, jan.vanlieshout@radboudumc.nl %K medication adherence %K improvement %K intervention %K web-based %K tailored intervention %K patient centered %K barriers %K primary care %K cardiovascular diseases %K diabetes %D 2022 %7 7.4.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Growing numbers of people use medication for chronic conditions; nonadherence is common, leading to poor disease control. A web-based tool to identify an increased risk for nonadherence with related potential individual barriers might facilitate tailored interventions and improve adherence. Objective: This study aims to assess the effectiveness of a newly developed tool aimed at improving medication adherence. Methods: We performed a cluster randomized controlled trial in patients initiating cardiovascular or oral blood glucose–lowering medication. Participants were recruited from community pharmacies. They completed an online questionnaire comprising assessments of their risk for medication nonadherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients with high nonadherence risk in face-to-face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by pharmacists. Barriers of control patients were not presented nor discussed and these patients received usual care. The primary outcome was the effectiveness of the intervention on medication adherence at 8 months’ follow-up between patients with an increased nonadherence risk from the intervention and control groups, calculated from dispensing data. Results: Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (B=–0.01; 95% CI –0.59 to 0.57; P=.96), nor in the post hoc per-protocol analysis (B=0.19; 95% CI –0.50 to 0.89; P=.58). Conclusions: This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effectiveness were identified. These explanations relate, for instance, to high medication adherence in the control group, study power, and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. Trial Registration: The Netherlands National Trial Register NTR5186; https://tinyurl.com/5d8w99hk %M 35389359 %R 10.2196/16141 %U https://www.jmir.org/2022/4/e16141 %U https://doi.org/10.2196/16141 %U http://www.ncbi.nlm.nih.gov/pubmed/35389359 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 4 %P e29211 %T Characterizing Use of a Multicomponent Digital Intervention to Predict Treatment Outcomes in First-Episode Psychosis: Cluster Analysis %A O'Sullivan,Shaunagh %A Schmaal,Lianne %A D'Alfonso,Simon %A Toenders,Yara Jo %A Valentine,Lee %A McEnery,Carla %A Bendall,Sarah %A Nelson,Barnaby %A Gleeson,John F %A Alvarez-Jimenez,Mario %+ Orygen, 35 Poplar Road, Parkville, 3052, Australia, 61 428 282 470, shaunagh.osullivan@orygen.org.au %K digital intervention %K digital health %K youth mental health %K psychotic disorders %K clustering %K usage metrics %K log data %K social networking %D 2022 %7 7.4.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Multicomponent digital interventions offer the potential for tailored and flexible interventions that aim to address high attrition rates and increase engagement, an area of concern in digital mental health. However, increased flexibility in use makes it difficult to determine which components lead to improved treatment outcomes. Objective: This study aims to identify user profiles on Horyzons, an 18-month digital relapse prevention intervention for first-episode psychosis that incorporates therapeutic content and social networking, along with clinical, vocational, and peer support, and to examine the predictive value of these user profiles for treatment outcomes. A secondary objective is to compare each user profile with young people receiving treatment as usual (TAU). Methods: Participants comprised 82 young people (aged 16-27 years) with access to Horyzons and 84 receiving TAU, recovering from first-episode psychosis. In addition, 6-month use data from the therapy and social networking components of Horyzons were used as features for K-means clustering for joint trajectories to identify user profiles. Social functioning, psychotic symptoms, depression, and anxiety were assessed at baseline and 6-month follow-up. General linear mixed models were used to examine the predictive value of user profiles for treatment outcomes and between each user profile with TAU. Results: A total of 3 user profiles were identified based on the following system use metrics: low use, maintained use of social components, and maintained use of both therapy and social components. The maintained therapy and social group showed improvements in social functioning (F2,51=3.58; P=.04), negative symptoms (F2,51=4.45; P=.02), and overall psychiatric symptom severity (F2,50=3.23; P=.048) compared with the other user profiles. This group also showed improvements in social functioning (F1,62=4.68; P=.03), negative symptoms (F1,62=14.61; P<.001), and overall psychiatric symptom severity (F1,63=5.66; P=.02) compared with the TAU group. Conversely, the maintained social group showed increases in anxiety compared with the TAU group (F1,57=7.65; P=.008). No differences were found between the low use group and the TAU group on treatment outcomes. Conclusions: Continued engagement with both therapy and social components might be key in achieving long-term recovery. Maintained social use and low use outcomes were broadly comparable with TAU, emphasizing the importance of maintaining engagement for improved treatment outcomes. Although the social network may be a key ingredient to increase sustained engagement, as users engaged with this more consistently, it should be leveraged as a tool to engage young people with therapeutic content to bring about social and clinical benefits. %M 35389351 %R 10.2196/29211 %U https://mental.jmir.org/2022/4/e29211 %U https://doi.org/10.2196/29211 %U http://www.ncbi.nlm.nih.gov/pubmed/35389351 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e33787 %T From Digital Health to Digital Well-being: Systematic Scoping Review %A Smits,Merlijn %A Kim,Chan Mi %A van Goor,Harry %A Ludden,Geke D S %+ Department of Surgery, Radboud University Medical Center, Geert Grooteplein Zuid 10, Nijmegen, 6525 GA, Netherlands, 31 634165922, merlijnsmits@hotmail.com %K well-being %K design %K evaluation %K technology assessment %K digital health %K eHealth %K mHealth %K telehealth %K mobile phone %D 2022 %7 4.4.2022 %9 Review %J J Med Internet Res %G English %X Background: Digital health refers to the proper use of technology for improving the health and well-being of people and enhancing the care of patients through the intelligent processing of clinical and genetic data. Despite increasing interest in well-being in both health care and technology, there is no clear understanding of what constitutes well-being, which leads to uncertainty in how to create well-being through digital health. In an effort to clarify this uncertainty, Brey developed a framework to define problems in technology for well-being using the following four categories: epistemological problem, scope problem, specification problem, and aggregation problem. Objective: This systematic scoping review aims to gain insights into how to define and address well-being in digital health. Methods: We followed the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. Papers were identified from 6 databases and included if they addressed the design or evaluation of digital health and reported the enhancement of patient well-being as their purpose. These papers were divided into design and evaluation papers. We studied how the 4 problems in technology for well-being are considered per paper. Results: A total of 117 studies were eligible for analysis (n=46, 39.3% design papers and n=71, 60.7% evaluation papers). For the epistemological problem, the thematic analysis resulted in various definitions of well-being, which were grouped into the following seven values: healthy body, functional me, healthy mind, happy me, social me, self-managing me, and external conditions. Design papers mostly considered well-being as healthy body and self-managing me, whereas evaluation papers considered the values of healthy mind and happy me. Users were rarely involved in defining well-being. For the scope problem, patients with chronic care needs were commonly considered as the main users. Design papers also regularly involved other users, such as caregivers and relatives. These users were often not involved in evaluation papers. For the specification problem, most design and evaluation papers focused on the provision of care support through a digital platform. Design papers used numerous design methods, whereas evaluation papers mostly considered pre-post measurements and randomized controlled trials. For the aggregation problem, value conflicts were rarely described. Conclusions: Current practice has found pragmatic ways of circumventing or dealing with the problems of digital health for well-being. Major differences exist between the design and evaluation of digital health, particularly regarding their conceptualization of well-being and the types of users studied. In addition, we found that current methodologies for designing and evaluating digital health can be improved. For optimal digital health for well-being, multidisciplinary collaborations that move beyond the common dichotomy of design and evaluation are needed. %M 35377328 %R 10.2196/33787 %U https://www.jmir.org/2022/4/e33787 %U https://doi.org/10.2196/33787 %U http://www.ncbi.nlm.nih.gov/pubmed/35377328 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e27900 %T Effectiveness of an Internet-Based and Telephone-Assisted Training for Parents of 4-Year-Old Children With Disruptive Behavior: Implementation Research %A Sourander,Andre %A Ristkari,Terja %A Kurki,Marjo %A Gilbert,Sonja %A Hinkka-Yli-Salomäki,Susanna %A Kinnunen,Malin %A Pulkki-Råback,Laura %A McGrath,Patrick J %+ Department of Child Psychiatry, University of Turku, Lemminkäisenkatu 3, Teutori 3rd floor, Turku, 20014, Finland, 358 40 5571633, andre.sourander@utu.fi %K parent training %K early intervention %K implementation %K disruptive behavior %K behavior problems %K preschool children %K internet-assisted %K child mental health %K mental health %K behavior %K intervention %K children %K parents %D 2022 %7 4.4.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: There is a lack of effectiveness studies when digital parent training programs are implemented in real-world practice. The efficacy of the internet-based and telephone-assisted Finnish Strongest Families Smart Website (SFSW) parent training intervention on the disruptive behavior of 4-year-old children was studied in a randomized controlled trial setting in Southwest Finland between 2011 and 2013. After that, the intervention was implemented nationwide in child health clinics from 2015 onwards. Objective: The main aim of this study was to compare the treatment characteristics and effectiveness of the SFSW parent training intervention between the families who received the intervention when it was implemented as a normal practice in child health clinics and the families who received the same intervention during the randomized controlled trial. Methods: The implementation group comprised 600 families who were recruited in the SFSW intervention between January 2015 and May 2017 in real-world implementation. The RCT intervention group comprised 232 families who were recruited between October 2011 and November 2013. The same demographic and child and parent measures were collected from both study groups and were compared using linear mixed-effect models for repeated measurements. The child psychopathology and functioning level were measured using the Child Behavior Checklist (CBCL) version 1.5-5 for preschool children, the Inventory of Callous-Unemotional Traits (ICU), and a modified version of the Barkley Home Situations Questionnaire. Parenting skills were measured using the 31-item Parenting Scale and the shorter 21-item Depression, Anxiety and Stress Scale (DASS-21). The estimated child and parent outcomes were adjusted for CBCL externalizing scores at baseline, maternal education, duration of the behavior problems, and paternal age. The baseline measurements of each outcome were used as covariates. Results: The implementation group was more likely to complete the intervention than the RCT intervention group (514/600, 85.7% vs 176/232, 75.9%, respectively; P<.001). There were no significant differences between the implementation and RCT intervention groups with regard to child measures, including CBCL externalizing score (–0.2, 95% CI –1.3 to 1.6; P=.83), total score (–0.7, 95% CI –3.0 to 4.5; P=.70), internalizing score (–0.3, 95% CI –1.0 to 1.6; P=.64), and ICU total score (–0.4, 95% Cl –1.9 to 1.2; P=.64). No significant difference was detected in the Parenting Scale total score (0.0, 95% Cl –0.1 to 0.1; P=.50), while DASS-21 total score differed nearly significantly (2.5, 95% Cl 0.0-5.1; P=.05), indicating better improvement in the implementation group. Conclusions: The internet-based and telephone-assisted SFSW parent training intervention was effectively implemented in real-world settings. These findings have implications for addressing the unmet needs of children with disruptive behavior problems. Our initiative could also provide a quick socially distanced solution for the considerable mental health impact of the COVID-19 pandemic. Trial Registration: ClinicalTrials.gov NCT01750996; https://clinicaltrials.gov/ct2/show/NCT01750996 International Registered Report Identifier (IRRID): RR2-10.1186/1471-2458-13-985 %M 35377332 %R 10.2196/27900 %U https://www.jmir.org/2022/4/e27900 %U https://doi.org/10.2196/27900 %U http://www.ncbi.nlm.nih.gov/pubmed/35377332 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 4 %P e22124 %T The Efficacy of Health Information Technology in Supporting Health Equity for Black and Hispanic Patients With Chronic Diseases: Systematic Review %A Senteio,Charles %A Murdock,Paul Joseph %+ Department of Library and Information Science, School of Communication and Information, Rutgers University, 4 Huntington St, New Brunswick, NJ, 08901-1071, United States, 1 8489327586, charles.senteio@rutgers.edu %K chronic disease %K minority health %K technology assessment %K biomedical %K self-management %K systematic review %K mobile phone %D 2022 %7 4.4.2022 %9 Review %J J Med Internet Res %G English %X Background: Racial inequity persists for chronic disease outcomes amid the proliferation of health information technology (HIT) designed to support patients in following recommended chronic disease self-management behaviors (ie, medication behavior, physical activity, and dietary behavior and attending follow-up appointments). Numerous interventions that use consumer-oriented HIT to support self-management have been evaluated, and some of the related literature has focused on racial minorities who experience disparate chronic disease outcomes. However, little is known about the efficacy of these interventions. Objective: This study aims to conduct a systematic review of the literature that describes the efficacy of consumer-oriented HIT interventions designed to support self-management involving African American and Hispanic patients with chronic diseases. Methods: We followed an a priori protocol using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses)-Equity 2012 Extension guidelines for systematic reviews that focus on health equity. Themes of interest included the inclusion and exclusion criteria. We identified 7 electronic databases, created search strings, and conducted the searches. We initially screened results based on titles and abstracts and then performed full-text screening. We then resolved conflicts and extracted relevant data from the included articles. Results: In total, there were 27 included articles. The mean sample size was 640 (SD 209.5), and 52% (14/27) of the articles focused on African American participants, 15% (4/27) of the articles focused on Hispanic participants, and 33% (9/27) included both. Most articles addressed 3 of the 4 self-management behaviors: medication (17/27, 63%), physical activity (17/27, 63%), and diet (16/27, 59%). Only 15% (4/27) of the studies focused on follow-up appointment attendance. All the articles investigated HIT for use at home, whereas 7% (2/27) included use in the hospital. Conclusions: This study addresses a key gap in research that has not sufficiently examined what technology designs and capabilities may be effective for underserved populations in promoting health behavior in concordance with recommendations. %M 35377331 %R 10.2196/22124 %U https://www.jmir.org/2022/4/e22124 %U https://doi.org/10.2196/22124 %U http://www.ncbi.nlm.nih.gov/pubmed/35377331 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 4 %P e34002 %T Brief Digital Interventions to Support the Psychological Well-being of NHS Staff During the COVID-19 Pandemic: 3-Arm Pilot Randomized Controlled Trial %A De Kock,Johannes H %A Latham,Helen Ann %A Cowden,Richard G %A Cullen,Breda %A Narzisi,Katia %A Jerdan,Shaun %A Munoz,Sarah-Anne %A Leslie,Stephen J %A Stamatis,Andreas %A Eze,Jude %+ Division of Rural Health and Wellbeing, Institute of Health Research and Innovation, School of Health, University of the Highlands and Islands, 12b Ness Walk, Inverness, IV3 5SQ, United Kingdom, 44 01463 255000, Hannes.De@nhs.scot %K eHealth %K public health %K depression %K anxiety %K well-being %K mobile health %K intervention studies %K staff %K occupational health %K NHS %K intervention %K support %K COVID-19 %K randomized controlled trial %D 2022 %7 4.4.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Health and social care staff are at high risk of experiencing adverse mental health (MH) outcomes during the COVID-19 pandemic. Hence, there is a need to prioritize and identify ways to effectively support their psychological well-being (PWB). Compared to traditional psychological interventions, digital psychological interventions are cost-effective treatment options that allow for large-scale dissemination and transcend social distancing, overcome rurality, and minimize clinician time. Objective: This study reports MH outcomes of a Consolidated Standards of Reporting Trials (CONSORT)-compliant parallel-arm pilot randomized controlled trial (RCT) examining the potential usefulness of an existing and a novel digital psychological intervention aimed at supporting psychological health among National Health Service (NHS) staff working through the COVID-19 pandemic. Methods: NHS Highland (NHSH) frontline staff volunteers (N=169) were randomly assigned to the newly developed NHSH Staff Wellbeing Project (NHSWBP), an established digital intervention (My Possible Self [MPS]), or a waitlist (WL) group for 4 weeks. Attempts were made to blind participants to which digital intervention they were allocated. The interventions were fully automated, without any human input or guidance. We measured 5 self-reported psychological outcomes over 3 time points: before (baseline), in the middle of (after 2 weeks), and after treatment (4 weeks). The primary outcomes were anxiety (7-item General Anxiety Disorder), depression (Patient Health Questionnaire), and mental well-being (Warwick-Edinburgh Mental Well-being Scale). The secondary outcomes included mental toughness (Mental Toughness Index) and gratitude (Gratitude Questionnaire-6). Results: Retention rates mid- and postintervention were 77% (n=130) and 63.3% (n=107), respectively. Postintervention, small differences were noted between the WL and the 2 treatment groups on anxiety (vs MPS: Cohen d=0.07, 95% CI –0.20 to 0.33; vs NHSWBP: Cohen d=0.06, 95% CI –0.19 to 0.31), depression (vs MPS: Cohen d=0.37, 95% CI 0.07-0.66; vs NHSWBP: Cohen d=0.18, 95% CI –0.11 to 0.46), and mental well-being (vs MPS: Cohen d=–0.04, 95% CI –0.62 to –0.08; vs NHSWBP: Cohen d=–0.15, 95% CI –0.41 to 0.10). A similar pattern of between-group differences was found for the secondary outcomes. The NHSWBP group generally had larger within-group effects than the other groups and displayed a greater rate of change compared to the other groups on all outcomes, except for gratitude, where the rate of change was greatest for the MPS group. Conclusions: Our analyses provided encouraging results for the use of brief digital psychological interventions in improving PWB among health and social care workers. Future multisite RCTs, with power to reliably detect differences, are needed to determine the efficacy of contextualized interventions relative to existing digital treatments. Trial Registration: ISRCTN Registry (ISRCTN) ISRCTN18107122; https://www.isrctn.com/ISRCTN18107122 %M 35044927 %R 10.2196/34002 %U https://mental.jmir.org/2022/4/e34002 %U https://doi.org/10.2196/34002 %U http://www.ncbi.nlm.nih.gov/pubmed/35044927 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 5 %N 2 %P e34822 %T Tele-Active Rehabilitation for Youth With Concussion: Evidence-Based and Theory-Informed Intervention Development %A Shore,Josh %A Nalder,Emily %A Hutchison,Michael %A Reed,Nick %A Hunt,Anne %+ Department of Occupational Science and Occupational Therapy, University of Toronto, Rehabilitation Sciences Building, 160-500 University Ave., Toronto, ON, M5G 1V7, Canada, 1 (416) 946 8568, anne.hunt@utoronto.ca %K concussion %K pediatrics %K active rehabilitation %K telehealth %K exercise %K mobile phone %D 2022 %7 4.4.2022 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Active rehabilitation involving subsymptom threshold exercise combined with education and support promotes recovery in youth with concussion but is typically delivered in person, which may limit accessibility for families because of a lack of services in their communities or logistical challenges to attending in-person sessions. Objective: This paper describes the evidence-based and theory-informed development of the Tele-Active Rehabilitation (Tele-AR) intervention for pediatric concussion, which was specifically designed for remote service delivery. Methods: The intervention was designed by clinician-researchers with experience in pediatric concussion rehabilitation following the Medical Research Council guidance for developing complex interventions. Development involved a critical review of the literature to identify existing evidence, the expansion of the theoretical basis for active rehabilitation, and the modeling of the intervention process and outcomes. Results: Tele-AR is a 6-week home exercise and education and support program facilitated through weekly videoconferencing appointments with a clinician. Exercise consists of low- to moderate-intensity subsymptom threshold aerobic activity and coordination drills that are individualized to participant needs and interests (prescribed for 3 days per week). Education includes the evidence-supported Concussion & You self-management program, which covers topics related to energy management, nutrition, hydration, sleep hygiene, and return to activity. Elements of self-determination theory are incorporated to support motivation and engagement. We present a logic model describing predicted intervention effects using a biopsychosocial conceptualization of outcomes after concussion. Conclusions: The Tele-AR intervention may help to increase access to care that improves recovery and promotes a timely return to activity in youth with concussion. Future research is needed to evaluate the feasibility and efficacy of this approach. %M 35377326 %R 10.2196/34822 %U https://pediatrics.jmir.org/2022/2/e34822 %U https://doi.org/10.2196/34822 %U http://www.ncbi.nlm.nih.gov/pubmed/35377326 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 2 %P e34134 %T Application of a Web-based Self-assessment Triage Tool During the COVID-19 Pandemic: Descriptive Study %A Nowicka,Anna %A Jaszczak,Jakub %A Szymanek Pasternak,Anna %A Simon,Krzysztof %+ Provincial Specialist Hospital them. J. Gromkowski, Koszarowa 5, Wrocław, 51-149, Poland, 48 660427576, nowickanna@gmail.com %K COVID-19 %K symptom checker %K preclinical triage %K self-assessment tool %K online applications %K COVID-19 remote triage %K COVID-19 self-assessment %D 2022 %7 4.4.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: The COVID-19 pandemic has sped up the implementation of telehealth solutions in medicine. A few symptom checkers dedicated for COVID-19 have been described, but it remains unclear whether and how they can affect patients and health systems. Objective: This paper demonstrates our experiences with the COVID-19 risk assessment (CRA) tool. We tried to determine who the user of the web-based COVID-19 triage app is and compare this group with patients in the infectious diseases ward’s admission room to evaluate who could benefit from implementing the COVID-19 online symptom checker as a remote triage solution. Methods: We analyzed the answers of 248,862 people interacting with an online World Health Organization–based triage tool for assessing the probability of SARS-CoV-2 infection. These users filled in an online questionnaire between April 7 and August 6, 2020. Based on the presented symptoms, risk factors, and demographics, the tool assessed whether the user’s answers were suggestive of COVID-19 and recommended appropriate action. Subsequently, we compared the sociodemographic and clinical characteristics of tool users with patients admitted to the Infectious Diseases Admission Room of J. Gromkowski Hospital in Wrocław. Results: The CRA tool tended to be used by asymptomatic or oligosymptomatic individuals (171,226 [68.80%] of all users). Most users were young (162,432 [65.27%] were below 40 years of age) and without comorbidities. Only 77,645 (31.20%) of the self-assessment app users were suspected of COVID-19 based on their reported symptoms. On the contrary, most admission room patients were symptomatic—symptoms such as fever, cough, and dyspnea were prevalent in both COVID-19-positive and COVID-19-negative patients. COVID-19-suspected patients in the CRA tool group presented similar COVID-19 symptoms as those who presented to the admission room. These were cough (25,062/40,007 [62.64%] in the CRA tool group vs 138/232 [59.48%] in the admission room group), fever (23,123/40,007 [57.80%] in the CRA tool group vs 146/232 [62.93%] in the admission room group), and shortness of breath (15,157/40,007 [37.89%] in the CRA tool group vs 87/232 [37.50%] in the admission room group). Conclusions: The comparison between the symptomatology of the users interacting with the CRA tool and those visiting the admission room revealed 2 major patient groups who could have benefited from the implementation of the self-assessment app in preclinical triage settings. The primary users of the CRA tool were young, oligosymptomatic individuals looking for screening for COVID-19 and reassurance early in the COVID-19 pandemic. The other group were users presenting the typical symptoms suggestive of COVID-19 at that time. The CRA tool recognized these individuals as potentially COVID-19 positive and directed them to the proper level of care. These use cases fulfil the idea of preclinical triage; however, the accuracy and influence on health care must be examined in the clinical setting. %M 35168192 %R 10.2196/34134 %U https://humanfactors.jmir.org/2022/2/e34134 %U https://doi.org/10.2196/34134 %U http://www.ncbi.nlm.nih.gov/pubmed/35168192 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e31839 %T The Impact of Web-Based Physical Activity Interventions on Depression and Anxiety Among College Students: Randomized Experimental Trial %A Murray,Andy %A Marenus,Michele %A Cahuas,Ana %A Friedman,Kathryn %A Ottensoser,Haley %A Kumaravel,Varun %A Sanowski,Julia %A Chen,Weiyun %+ Physical Activity and Health Laboratory, School of Kinesiology, University of Michigan, SKB 4250, 830 N University Ave, Ann Arbor, MI, 48109, United States, 1 (734) 615 0376, chenwy@umich.edu %K depression %K anxiety %K college students %K mindfulness %K aerobic exercise %K resistance training %K web-based intervention %D 2022 %7 1.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Depression and anxiety are growing issues for college students, with both aerobic resistance training and mindfulness yoga exercises known to be effective in reducing symptoms and severity. However, no known research is available comparing these 2 depression and anxiety interventions simultaneously and in a web-based environment. Objective: This study aims to determine the effects of a web-based aerobic resistance exercise intervention (WeActive) and a web-based yoga mindfulness exercise intervention (WeMindful) on depression and anxiety symptoms in college students. Methods: The participants were 77 college students who anonymously completed a Qualtrics survey, including the Generalized Anxiety Disorder Scale and the Major Depression Inventory at baseline and after the intervention. Participants were randomly assigned to either the WeActive or WeMindful group and underwent two 30-minute web-based aerobic resistance exercise lessons or yoga mindfulness lessons per week for 8 weeks. Results: The results of analysis of covariance with repeated measures indicated that although not statistically significant, both groups showed a notable decrease in anxiety with a marginally significant main effect of time (F1=3.485; P=.07; η2=0.047) but no significant main effect of group and no significant interaction effect of time with group. The 2 intervention groups experienced a significant decrease in depression with the main effect of time (F=3.892; P=.05; η2=0.052). There was no significant main effect of group or interaction effect of time with group for depression. Conclusions: College students in both WeActive and WeMindful groups experienced a significant decrease in depression symptoms and a decrease, although not significant, in anxiety as well. The study suggests that web-based WeActive and WeMindful interventions are effective approaches to managing US college students’ depression and anxiety during a pandemic. %M 35363151 %R 10.2196/31839 %U https://formative.jmir.org/2022/4/e31839 %U https://doi.org/10.2196/31839 %U http://www.ncbi.nlm.nih.gov/pubmed/35363151 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 4 %P e33783 %T Efficacy of a Digital Acceptance and Commitment Therapy Intervention for the Improvement of Self-management Behaviors and Psychological Flexibility in Adults With Cardiac Disease: Protocol for a Single Case Experimental Design %A Moran,Orla %A Doyle,Julie %A Giggins,Oonagh %A McHugh,Louise %A Gould,Evelyn %A Smith,Suzanne %A Gavin,Shane %A Sojan,Nisanth %A Boyle,Gordon %+ NetwellCASALA, Dundalk Institute of Technology, PJ Carroll Building, Dublin Road, Dundalk, A91 K584, Ireland, 353 429370400 ext 2074, orla.moran@dkit.ie %K cardiac disease %K acceptance and commitment therapy %K distress management %K self-management %K single case experimental design %K digital health %D 2022 %7 1.4.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Research indicates that the management of distress levels in those with cardiac disease is not only important for improving quality of life and functioning but also critical for condition management; adherence to treatment; and, ultimately, disease prognosis and progression. Acceptance and commitment therapy (ACT) has consistently demonstrated positive long-term outcomes across a wide array of conditions, including chronic illness. However, most empirical investigations conducted to date have also involved in-person therapy, which can be difficult to access, particularly for those dealing with the demands of chronic disease. Objective: The objective of our research is to evaluate a digital ACT intervention for improving self-management behaviors and distress levels in those with cardiac conditions. Methods: The digital ACT intervention will be delivered via a digital health self-management platform over 6 sessions. This will involve a randomized, multiple baseline, single case experimental design with approximately 3 to 15 adults with cardiac disease. The independent variable for each participant will be the pre-post intervention phase. The dependent variables will be a daily self-report measure of psychological flexibility as well as objective measures of condition self-management (eg, blood pressure readings) and engagement with the app (eg, completing guided mindfulness). One-to-one qualitative interviews will also be conducted to further examine participants’ experiences with using the intervention and what factors contribute to or impede successful outcomes. Results: Participant recruitment and data collection began in October 2021, and it is projected that the study findings will be available for dissemination by spring 2022. Conclusions: The findings will be discussed in terms of how a digital ACT intervention can best meet the needs of cardiac patients. International Registered Report Identifier (IRRID): PRR1-10.2196/33783 %M 35363156 %R 10.2196/33783 %U https://www.researchprotocols.org/2022/4/e33783 %U https://doi.org/10.2196/33783 %U http://www.ncbi.nlm.nih.gov/pubmed/35363156 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e25224 %T Effect of a Lifestyle-Focused Web-Based Application on Risk Factor Management in Patients Who Have Had a Myocardial Infarction: Randomized Controlled Trial %A Ögmundsdóttir Michelsen,Halldóra %A Sjölin,Ingela %A Bäck,Maria %A Gonzalez Garcia,Manuel %A Olsson,Anneli %A Sandberg,Camilla %A Schiopu,Alexandru %A Leósdóttir,Margrét %+ Department of Clinical Sciences Malmö, Lund University, Jan Waldenströms Gata 35, Malmö, 205 02, Sweden, 46 4061000, halldora.michelsen@med.lu.se %K eHealth %K cardiac rehabilitation %K cardiovascular %K mobile device app %K risk factors %K web-based application %K mobile phone %D 2022 %7 31.3.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Cardiac rehabilitation is central in reducing mortality and morbidity after myocardial infarction. However, the fulfillment of guideline-recommended cardiac rehabilitation targets is unsatisfactory. eHealth offers new possibilities to improve clinical care. Objective: This study aims to assess the effect of a web-based application designed to support adherence to lifestyle advice and self-control of risk factors (intervention) in addition to center-based cardiac rehabilitation, compared with cardiac rehabilitation only (usual care). Methods: All 150 patients participated in cardiac rehabilitation. Patients randomized to the intervention group (n=101) received access to the application for 25 weeks where information about lifestyle (eg, diet and physical activity), risk factors (eg, weight and blood pressure [BP]), and symptoms could be registered. The software provided feedback and lifestyle advice. The primary outcome was a change in submaximal exercise capacity (Watts [W]) between follow-up visits. Secondary outcomes included changes in modifiable risk factors between baseline and follow-up visits and uptake and adherence to the application. Regression analysis was used, adjusting for relevant baseline variables. Results: There was a nonsignificant trend toward a larger change in exercise capacity in the intervention group (n=66) compared with the usual care group (n=40; +14.4, SD 19.0 W, vs +10.3, SD 16.1 W; P=.22). Patients in the intervention group achieved significantly larger BP reduction compared with usual care patients at 2 weeks (systolic −27.7 vs −16.4 mm Hg; P=.006) and at 6 to 10 weeks (systolic −25.3 vs −16.4 mm Hg; P=.02, and diastolic −13.4 vs −9.1 mm Hg; P=.05). A healthy diet index score improved significantly more between baseline and the 2-week follow-up in the intervention group (+2.3 vs +1.4 points; P=.05), mostly owing to an increase in the consumption of fish and fruit. At 6 to 10 weeks, 64% (14/22) versus 46% (5/11) of smokers in the intervention versus usual care groups had quit smoking, and at 12 to 14 months, the respective percentages were 55% (12/22) versus 36% (4/11). However, the number of smokers in the study was low (33/149, 21.9%), and the differences were nonsignificant. Attendance in cardiac rehabilitation was high, with 96% (96/100) of patients in the intervention group and 98% (48/49) of patients receiving usual care only attending 12- to 14-month follow-up. Uptake (logging data in the application at least once) was 86.1% (87/101). Adherence (logging data at least twice weekly) was 91% (79/87) in week 1 and 56% (49/87) in week 25. Conclusions: Complementing cardiac rehabilitation with a web-based application improved BP and dietary habits during the first months after myocardial infarction. A nonsignificant tendency toward better exercise capacity and higher smoking cessation rates was observed. Although the study group was small, these positive trends support further development of eHealth in cardiac rehabilitation. Trial Registration: ClinicalTrials.gov NCT03260582; https://clinicaltrials.gov/ct2/show/NCT03260582 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-018-3118-1 %M 35357316 %R 10.2196/25224 %U https://www.jmir.org/2022/3/e25224 %U https://doi.org/10.2196/25224 %U http://www.ncbi.nlm.nih.gov/pubmed/35357316 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e27945 %T Effect of Source Type and Protective Message on the Critical Evaluation of News Messages on Facebook: Randomized Controlled Trial in the Netherlands %A Folkvord,Frans %A Snelting,Freek %A Anschutz,Doeschka %A Hartmann,Tilo %A Theben,Alexandra %A Gunderson,Laura %A Vermeulen,Ivar %A Lupiáñez-Villanueva,Francisco %+ Open Evidence Research, Open Evidence, Avinguda Tibidabo 35, Barcelona, 08035, Spain, 34 31610948122, fransfolkvord@gmail.com %K health communication %K disinformation %K protective message %K source %K critical evaluation %K critical thinking %D 2022 %7 31.3.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Disinformation has become an increasing societal concern, especially due to the speed that news is shared in the digital era. In particular, disinformation in the health care sector can lead to serious casualties, as the current COVID-19 crisis clearly shows. Objective: The main aim of this study was to experimentally examine the effects of information about the source and a protective warning message on users’ critical evaluation of news items, as well as the perception of accuracy of the news item. Methods: A 3 (unreliable vs reliable vs no identified source) × 2 (with protective message vs without) between-subject design was conducted among 307 participants (mean age 29 (SD 10.9] years). Results: The results showed a significant effect of source information on critical evaluation. In addition, including a protective message did not significantly affect critical evaluation. The results showed no interaction between type of source and protective message on critical evaluation. Conclusions: Based on these results, it is questionable whether including protective messages to improve critical evaluation is a way to move forward and improve critical evaluation of health-related news items, although effective methodologies to tackle the spread of disinformation are highly needed. Trial Registration: ClinicalTrials.gov NCT05030883; https://clinicaltrials.gov/ct2/show/NCT05030883 %M 35357314 %R 10.2196/27945 %U https://www.jmir.org/2022/3/e27945 %U https://doi.org/10.2196/27945 %U http://www.ncbi.nlm.nih.gov/pubmed/35357314 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e31419 %T Efficacy, Benefits, and Harms of a Self-management App in a Swedish Trauma-Exposed Community Sample (PTSD Coach): Randomized Controlled Trial %A Hensler,Ida %A Sveen,Josefin %A Cernvall,Martin %A Arnberg,Filip K %+ National Centre for Disaster Psychiatry, Department of Medical Sciences, Uppsala University, Akademiska sjukhuset ing. 10 van. 3, Uppsala, 75185, Sweden, 46 186170896, ida.hensler@neuro.uu.se %K PTSD %K self-management app %K mHealth %K RCT %K negative effects %K mobile phone %D 2022 %7 30.3.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Self-guided interventions may complement and overcome obstacles to in-person treatment options. The efficacy of app interventions targeting posttraumatic stress disorder (PTSD) is unclear, and results from previous studies on PTSD Coach—an app for managing trauma-related distress—are inconsistent. Objective: This study investigates whether access to the Swedish version of the PTSD Coach affects posttraumatic stress, depressive, and somatic symptoms. In addition, we aim to assess the perceived helpfulness, satisfaction, negative effects, response, and remission related to PTSD Coach. Methods: Adults who had experienced potentially traumatic events in the past 2 years were randomized (1:1) to have access to PTSD Coach (n=89) or be on the waitlist (n=90). We assessed clinical characteristics at baseline (semistructured interviews and self-rating scales) and after 3 months (self-rating scales). We analyzed the data in R software using linear mixed effects models, chi-square tests, and Fisher exact test. Results: Intention-to-treat analyses indicated that access to PTSD Coach decreased posttraumatic stress and depressive symptoms but not somatic symptoms. More participants who had access to PTSD Coach responded with clinically significant improvement and fewer instances of probable PTSD after 3 months compared with waitlist controls. Overall, participants found that PTSD Coach was slightly to moderately helpful and moderately satisfactory. Half of the intervention group (36/71, 51%) reported at least one negative reaction related to using PTSD Coach (eg, disappointment with the app or its results, arousal of stress, or distressing memories). Conclusions: Using PTSD Coach may trigger symptoms among a few users; however, most of them perceived PTSD Coach as helpful and satisfactory. This study showed that having access to PTSD Coach helped improve psychological trauma-related symptoms. In addition, we have discussed implications for future research and clinical practice. Trial Registration: ClinicalTrials.gov NCT04094922; https://clinicaltrials.gov/ct2/show/NCT04094922 %M 35353052 %R 10.2196/31419 %U https://www.jmir.org/2022/3/e31419 %U https://doi.org/10.2196/31419 %U http://www.ncbi.nlm.nih.gov/pubmed/35353052 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 3 %P e30571 %T Web-Based TangPlan and WeChat Combination to Support Self-management for Patients With Type 2 Diabetes: Randomized Controlled Trial %A Xia,Shu-Fang %A Maitiniyazi,Gusonghan %A Chen,Yue %A Wu,Xiao-Ya %A Zhang,Yu %A Zhang,Xiao-Yan %A Li,Zi-Yuan %A Liu,Yuan %A Qiu,Yu-Yu %A Wang,Jun %+ Department of Rehabilitation, Wuxi 9th Affiliated Hospital of Soochow University, NO. 999, Liangxi Road, Wuxi, 214063, China, 86 51085867999, wangjun2115@suda.edu.cn %K type 2 diabetes %K glucose control %K TangPlan %K WeChat %K self-management %D 2022 %7 30.3.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: China has the largest number of patients with type 2 diabetes mellitus (T2DM) in the world. However, owing to insufficient knowledge of self-management in patients with diabetes, blood glucose (BG) control is poor. Most diabetes-related self-management applications fail to bring significant benefits to patients with T2DM because of the low use rate and difficult operation. Objective: This study aims to examine the effectiveness of the combination of the self-designed web-based T2DM management software TangPlan and WeChat on fasting BG (FBG), glycated hemoglobin (HbA1c), body weight, blood pressure (BP), and lipid profiles in patients with T2DM over a 6-month period. Methods: Participants were recruited and randomized into the TangPlan and WeChat or control groups. Participants in the control group received usual care, whereas the TangPlan and WeChat participants received self-management guidance with the help of TangPlan and WeChat from health care professionals, including BG self-monitoring; healthy eating; active physical exercise; increasing medication compliance; and health education during follow-ups, lectures, or web-based communication. They were also asked to record and send self-management data to the health care professionals via WeChat to obtain timely and effective guidance on diabetes self-management. Results: In this study, 76.9% (120/156) of participants completed the 6-month follow-up visit. After the intervention, FBG (mean 6.51, SD 1.66 mmol/L; P=.048), HbA1c (mean 6.87%, SD 1.11%; P<.001), body weight (mean 66.50, SD 9.51 kg; P=.006), systolic BP (mean 127.03, SD 8.00 mm Hg; P=.005), diastolic BP (mean 75.25, SD 5.88 mm Hg; P=.03), serum low-density lipoprotein cholesterol (mean 2.50, SD 0.61 mmol/L; P=.006), and total cholesterol (mean 4.01, SD 0.83 mmol/L; P=.02) in the TangPlan and WeChat group were all significantly lower, whereas serum high-density lipoprotein cholesterol (mean 1.20, SD 0.25 mmol/L; P=.01) was remarkably higher than in those in the control group. Compared with the baseline data, significance was found in the mean change in FBG (95% CI −0.83 to −0.20; P=.002), HbA1c (95% CI −1.92 to −1.28; P<.001), body weight (95% CI −3.13 to −1.68; P<.001), BMI (95% CI −1.10 to −0.60; P<.001), systolic BP (95% CI −7.37 to −3.94; P<.001), diastolic BP (95% CI −4.52 to −2.33; P<.001), triglycerides (95% CI −0.16 to −0.03; P=.004), serum low-density lipoprotein cholesterol (95% CI −0.54 to −0.30; P<.001), and total cholesterol (95% CI −0.60 to −0.34; P<.001) in the TangPlan and WeChat group but not in the control group (P=.08-.88). Conclusions: Compared with usual care for patients with T2DM, the combination of TangPlan and WeChat was effective in improving glycemic control (decrease in HbA1c and BG levels) and serum lipid profiles as well as reducing body weight in patients with T2DM after 6 months. Trial Registration: Chinese Clinical Trial Registry ChiCTR2000028843; https://tinyurl.com/559kuve6 %M 35353055 %R 10.2196/30571 %U https://mhealth.jmir.org/2022/3/e30571 %U https://doi.org/10.2196/30571 %U http://www.ncbi.nlm.nih.gov/pubmed/35353055 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e34301 %T Barriers and Considerations in the Design and Implementation of Digital Behavioral Interventions: Qualitative Analysis %A Marcu,Gabriela %A Ondersma,Steven J %A Spiller,Allison N %A Broderick,Brianna M %A Kadri,Reema %A Buis,Lorraine R %+ Department of Family Medicine, University of Michigan, 1018 Fuller Street, Ann Arbor, MI, 48104-1213, United States, 1 734 998 7120, buisl@umich.edu %K computers %K mobile apps %K screening %K brief interventions %K diagnosis %K computer-assisted/methods %K surveys and questionnaires %K motivational interviewing %K therapy %K implementation %K qualitative %K mobile phone %D 2022 %7 30.3.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital behavioral interventions have become increasingly popular for their ability to support patient diagnosis and treatment, chronic disease self-management, behavior change, and adherence to recommended care. However, digital intervention development is impeded by challenges such as limited technical skills, limited access to developers, and cost. The purpose of this study is to elicit in-depth qualitative feedback from intervention developers who have interest in digital behavioral interventions but lack programming skills regarding the barriers they experience and key considerations in the design and implementation of digital interventions. Objective: This study aims to understand barriers in the design and implementation of digital behavioral interventions, as well as to identify key considerations for researchers who are developing these interventions. Methods: We conducted semistructured qualitative interviews with 18 researchers who had experience either designing (but not coding) digital behavioral interventions or running research studies with them. Participants were a convenience sample of users of the Computerized Intervention Authoring System platform, an existing no-code development platform for building digital intervention content, and were recruited through either direct email solicitation or snowball sampling. All interviews were conducted and recorded over videoconference between February and April 2020. Recordings from interviews were transcribed and thematically analyzed by multiple coders. Results: Interviews were completed with 18 participants and lasted between 24 and 65 (mean 46.9, SD 11.3) minutes. Interviewees were predominantly female (17/18, 94%) and represented different job roles, ranging from researcher to project/study staff. Three key barriers in the development of digital behavior interventions were identified during interviews: lack of cross-disciplinary understanding; variability in recipients’ technology access, infrastructure, and literacy; and the idea that evidence-based in-person interactions do not translate directly to digital interactions. Interviewees identified several key considerations that interventionists learned to prioritize, which have the potential to overcome these barriers and lead to successful interventions. Conclusions: Barriers in the development of digital behavioral interventions are often created by a lack of cross-disciplinary understanding, which can lead to difficulties conceptualizing interventions, unrealistic expectations in terms of cost, and confusion about the development process. Moreover, concerns about research study participant characteristics and access to technology, as well as the translation of in-person interventions to digital, are apparent. Appropriate training in how to work with software development teams may help future digital behavior intervention creators overcome these barriers and may lead to new, exciting innovations in this space. %M 35353043 %R 10.2196/34301 %U https://www.jmir.org/2022/3/e34301 %U https://doi.org/10.2196/34301 %U http://www.ncbi.nlm.nih.gov/pubmed/35353043 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e34300 %T The Perceived Benefits of Digital Interventions for Behavioral Health: Qualitative Interview Study %A Marcu,Gabriela %A Ondersma,Steven J %A Spiller,Allison N %A Broderick,Brianna M %A Kadri,Reema %A Buis,Lorraine R %+ Department of Family Medicine, University of Michigan, 1018 Fuller Street, Ann Arbor, MI, 48104-1213, United States, 1 734 998 7120, buisl@umich.edu %K computers %K mobile apps %K screening %K brief interventions %K diagnosis %K computer-assisted/methods %K surveys and questionnaires %K motivational interviewing %K therapy %K computer-assisted/methods %K implementation %K qualitative %K mobile phone %D 2022 %7 30.3.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital interventions have gained momentum in terms of behavioral health. However, owing to lacking standard approaches or tools for creating digital behavioral interventions, clinical researchers follow widely varying conceptions of how best to go about digital intervention development. Researchers also face significant cost-, time-, and expertise-related challenges in digital intervention development. Improving the availability of tools and guidance for researchers will require a thorough understanding of the motivations and needs of researchers seeking to create digital interventions. Objective: This study aims to understand the perceptions of behavioral researchers toward digital interventions, and inform the use of these interventions, by documenting the reasons why researchers are increasingly focusing their efforts on digital interventions and their perspectives on the perceived benefits that digital approaches can provide for researchers and intervention recipients. Methods: We conducted semistructured qualitative interviews with 18 researchers who had experience designing digital behavioral interventions or running studies with them. A convenience sample of interviewees was recruited from among users of the Computerized Intervention Authoring System platform, a web-based tool that facilitates the process of creating and deploying digital interventions in behavioral research. Interviews were conducted over teleconference between February and April 2020. Recordings from the interviews were transcribed and thematically analyzed by multiple coders. Results: Interviews were completed with 18 individuals and lasted between 24 and 65 (mean 46.9, SD 11.3) minutes. Interviewees were predominantly female (17/18, 94%) and represented different job roles, ranging from researcher to project or study staff. Four major themes came out of the interviews concerning the benefits of digital interventions for behavioral health: convenience and flexibility for interventionists and recipients, support for implementing evidence-based interventions with fidelity, scaling and improving access to interventions, and getting a foot in the door despite stigma and disenfranchisement. Conclusions: Interviewees described a number of important potential benefits of digital interventions, particularly with respect to scientific rigor, scalability, and overcoming barriers to reaching more people. There are complex considerations with regard to translating behavior change strategies into digital forms of delivery, and interventionists make individual, sometimes unexpected, choices with minimal evidence of their relative effectiveness. Future research should investigate how behavioral researchers can be supported in making these choices toward usability, ease of access, and approachability of digital interventions. Our study underscores the need for authoring platforms that can facilitate the process of creating and deploying digital interventions to reach their full potential for interventionists and recipients alike. %M 35353045 %R 10.2196/34300 %U https://www.jmir.org/2022/3/e34300 %U https://doi.org/10.2196/34300 %U http://www.ncbi.nlm.nih.gov/pubmed/35353045 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 3 %P e34744 %T PTSD Coach Version 3.1: A Closer Look at the Reach, Use, and Potential Impact of This Updated Mobile Health App in the General Public %A Hallenbeck,Haijing Wu %A Jaworski,Beth K %A Wielgosz,Joseph %A Kuhn,Eric %A Ramsey,Kelly M %A Taylor,Katherine %A Juhasz,Katherine %A McGee-Vincent,Pearl %A Mackintosh,Margaret-Anne %A Owen,Jason E %+ Dissemination and Training Division, National Center for Posttraumatic Stress Disorder, Veterans Affairs Palo Alto Health Care System, 795 Willow Rd, Menlo Park, CA, 94025, United States, 1 650 493 5000, haijing.hallenbeck@stanford.edu %K posttraumatic stress disorder %K trauma %K mental health %K mHealth %K mobile app %K public health %K self-management %K mobile phone %D 2022 %7 29.3.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: With widespread smartphone ownership, mobile health apps (mHealth) can expand access to evidence-based interventions for mental health conditions, including posttraumatic stress disorder (PTSD). Research to evaluate new features and capabilities in these apps is critical but lags behind app development. The initial release of PTSD Coach, a free self-management app developed by the US Departments of Veterans Affairs and Defense, was found to have a positive public health impact. However, major stakeholder-driven updates to the app have yet to be evaluated. Objective: We aimed to characterize the reach, use, and potential impact of PTSD Coach Version 3.1 in the general public. As part of characterizing use, we investigated the use of specific app features, which extended previous work on PTSD Coach. Methods: We examined the naturalistic use of PTSD Coach during a 1-year observation period between April 20, 2020, and April 19, 2021, using anonymous in-app event data to generate summary metrics for users. Results: During the observation period, PTSD Coach was broadly disseminated to the public, reaching approximately 150,000 total users and 20,000 users per month. On average, users used the app 3 times across 3 separate days for 18 minutes in total, with steep drop-offs in use over time; a subset of users, however, demonstrated high or sustained engagement. More than half of users (79,099/128,691, 61.46%) accessed one or more main content areas of the app (ie, Manage Symptoms, Track Progress, Learn, or Get Support). Among content areas, features under Manage Symptoms (including coping tools) were accessed most frequently, by over 40% of users (53,314/128,691, 41.43% to 56,971/128,691, 44.27%, depending on the feature). Users who provided initial distress ratings (56,971/128,691, 44.27%) reported relatively high momentary distress (mean 6.03, SD 2.52, on a scale of 0-10), and the use of a coping tool modestly improved momentary distress (mean −1.38, SD 1.70). Among users who completed at least one PTSD Checklist for DSM-5 (PCL-5) assessment (17,589/128,691, 13.67%), PTSD symptoms were largely above the clinical threshold (mean 49.80, SD 16.36). Among users who completed at least two PCL-5 assessments (4989/128,691, 3.88%), PTSD symptoms decreased from the first to last assessment (mean −4.35, SD 15.29), with approximately one-third (1585/4989, 31.77%) of these users experiencing clinically significant improvements. Conclusions: PTSD Coach continues to fulfill its mission as a public health resource. Version 3.1 compares favorably with version 1 on most metrics related to reach, use, and potential impact. Although benefits appear modest on an individual basis, the app provides these benefits to a large population. For mHealth apps to reach their full potential in supporting trauma recovery, future research should aim to understand the utility of individual app features and identify strategies to maximize overall effectiveness and engagement. %M 35348458 %R 10.2196/34744 %U https://mental.jmir.org/2022/3/e34744 %U https://doi.org/10.2196/34744 %U http://www.ncbi.nlm.nih.gov/pubmed/35348458 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 3 %P e30754 %T Measuring Adherence Within a Self-Guided Online Intervention for Depression and Anxiety: Secondary Analyses of a Randomized Controlled Trial %A Hanano,Maria %A Rith-Najarian,Leslie %A Boyd,Meredith %A Chavira,Denise %+ Department of Psychology, University of California, Los Angeles, 1285 Franz Hall, Box 951563, Los Angeles, CA, 90095, United States, 1 9493501523, mariahanano@g.ucla.edu %K self-guided %K adherence %K depression %K anxiety %K online intervention %D 2022 %7 28.3.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Self-guided online interventions offer users the ability to participate in an intervention at their own pace and address some traditional service barriers (eg, attending in-person appointments, cost). However, these interventions suffer from high dropout rates, and current literature provides little guidance for defining and measuring online intervention adherence as it relates to clinical outcomes. Objective: This study aims to develop and test multiple measures of adherence to a specific self-guided online intervention, as guided by best practices from the literature. Methods: We conducted secondary analyses on data from a randomized controlled trial of an 8-week online cognitive behavioral program that targets depression and anxiety in college students. We defined multiple behavioral and attitudinal adherence measures at varying levels of effort (ie, low, moderate, and high). Linear regressions were run with adherence terms predicting improvement in the primary outcome measure, the 21-item Depression, Anxiety, and Stress Scale (DASS-21). Results: Of the 947 participants, 747 initiated any activity and 449 provided posttest data. Results from the intent-to-treat sample indicated that high level of effort for behavioral adherence significantly predicted symptom change (F4,746=17.18, P<.001; and β=–.26, P=.04). Moderate level of effort for attitudinal adherence also significantly predicted symptom change (F4,746=17.25, P<.001; and β=–.36, P=.03). Results differed in the initiators-only sample, such that none of the adherence measures significantly predicted symptom change (P=.09-.27). Conclusions: Our findings highlight the differential results of dose-response models testing adherence measures in predicting clinical outcomes. We summarize recommendations that might provide helpful guidance to future researchers and intervention developers aiming to investigate online intervention adherence. Trial Registration: ClinicalTrials.gov NCT04361045; https://clinicaltrials.gov/ct2/show/NCT04361045 %M 35343901 %R 10.2196/30754 %U https://mental.jmir.org/2022/3/e30754 %U https://doi.org/10.2196/30754 %U http://www.ncbi.nlm.nih.gov/pubmed/35343901 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 5 %N 1 %P e34967 %T Effectiveness of Mobile Apps in Promoting Healthy Behavior Changes and Preventing Obesity in Children: Systematic Review %A Yau,Kiana W %A Tang,Tricia S %A Görges,Matthias %A Pinkney,Susan %A Kim,Annie D %A Kalia,Angela %A Amed,Shazhan %+ Research Institute, BC Children's Hospital, A4-196, 950 West 28 Avenue, Vancouver, BC, V5Z 4H4, Canada, 1 604 875 3113, SAmed@cw.bc.ca %K childhood obesity %K mobile health %K health behaviors %K prevention %K study design %K systematic review %K mobile phone %D 2022 %7 28.3.2022 %9 Review %J JMIR Pediatr Parent %G English %X Background: Mobile apps have been increasingly incorporated into healthy behavior promotion interventions targeting childhood obesity. However, their effectiveness remains unclear. Objective: This paper aims to conduct a systematic review examining the effectiveness of mobile apps aimed at preventing childhood obesity by promoting health behavior changes in diet, physical activity, or sedentary behavior in children aged 8 to 12 years. Methods: MEDLINE, Embase, PsycINFO, CINAHL, and ERIC were systematically searched for peer-reviewed primary studies from January 2008 to July 2021, which included children aged 8 to 12 years; involved mobile app use; and targeted at least one obesity-related factor, including diet, physical activity, or sedentary behavior. Data extraction and risk of bias assessments were conducted by 2 authors. Results: Of the 13 studies identified, most used a quasi-experimental design (n=8, 62%). Significant improvements in physical activity (4/8, 50% studies), dietary outcomes (5/6, 83% studies), and BMI (2/6, 33% studies) were reported. All 6 multicomponent interventions and 57% (4/7) of standalone interventions reported significant outcomes in ≥1 behavioral change outcome measured (anthropometric, physical activity, dietary, and screen time outcomes). Gamification, behavioral monitoring, and goal setting were common features of the mobile apps used in these studies. Conclusions: Apps for health behavior promotion interventions have the potential to increase the adoption of healthy behaviors among children; however, their effectiveness in improving anthropometric measures remains unclear. Further investigation of studies that use more rigorous study designs, as well as mobile apps as a standalone intervention, is needed. %M 35343908 %R 10.2196/34967 %U https://pediatrics.jmir.org/2022/1/e34967 %U https://doi.org/10.2196/34967 %U http://www.ncbi.nlm.nih.gov/pubmed/35343908 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 5 %N 1 %P e32420 %T A Digital Health Program Targeting Physical Activity Among Adolescents With Overweight or Obesity: Open Trial %A Cummings,Caroline %A Crochiere,Rebecca %A Lansing,Amy Hughes %A Patel,Riya %A Stanger,Catherine %+ Department of Psychological Sciences, Texas Tech University, PO Box 42051, Lubbock, TX, 79409, United States, 1 8068340931, carolicu@ttu.edu %K mHealth program %K physical activity %K adolescent overweight %K adolescent obesity %K incentives %K mobile phone %D 2022 %7 28.3.2022 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Prior studies suggest that mobile health physical activity programs that provide only weekly or daily text-based health coaching evidence limit the efficacy in improving physical activity in adolescents with overweight or obesity. It is possible that incentives, combined with health coaching and daily feedback on goal success, may increase program efficacy; however, such programs have not yet been tested with adolescents with overweight and obesity. Objective: This study aims to examine the feasibility and acceptability of a 12-week, incentive-based, mobile health physical activity program with text-based health coaching, goal setting, and self-monitoring for adolescents with overweight or obesity. Program adherence and changes in tracked physical activity (ie, steps and active minutes while wearing a Fitbit [Google LLC]), body mass, and body fat are assessed. Methods: A total of 28 adolescents aged 13 to 18 years with a BMI ≥90th percentile participated in the program. Of the 28 participants, 2 (7%) were lost to follow-up; thus, data from 26 (93%) participants were used in analyses. Results: Participant-reported acceptability was high, with all mean ratings of text-based coaching, Fitbit use, and the overall program being >5 on a 7-point scale. In addition, 85% (23/26) of participants reported that they would like to continue to wear the Fitbit. Program adherence was also high, as participants wore the Fitbit on 91.1% (SD 12.6%) of days on average and met their weekly goals for an average of 7 (SD 3.5) of 11 possible weeks. There were no demographic (ie, sex, age, and baseline body mass) differences in the percentage of days participants wore their Fitbit. Across the 12-week study, there were significant improvements in tracked daily active minutes (P=.006) and steps (P<.001) and significant pre- to posttest improvements in body fat percentage (P=.04). Conclusions: The pilot program improved adolescent physical activity and physical health. A larger factorial design trial with adaptive daily goals may clarify the role of each program component in driving physical activity. %M 35343903 %R 10.2196/32420 %U https://pediatrics.jmir.org/2022/1/e32420 %U https://doi.org/10.2196/32420 %U http://www.ncbi.nlm.nih.gov/pubmed/35343903 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e33073 %T Patient- and Provider-Reported Experiences of a Mobile Novel Digital Therapeutic in People With Opioid Use Disorder (reSET-O): Feasibility and Acceptability Study %A Kawasaki,Sarah %A Mills-Huffnagle,Sara %A Aydinoglo,Nicole %A Maxin,Halley %A Nunes,Edward %+ Department of Psychiatry and Behavioral Health, Penn State Health, 500 University Drive, Box H073, Hershey, PA, 17033, United States, 1 7177826844, skawasaki@pennstatehealth.psu.edu %K reSET-O %K digital therapeutic %K opioid use disorder %K prescription digital therapeutic %D 2022 %7 25.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Medications for the treatment of opioid use disorder, such as buprenorphine, are effective and essential for addressing the opioid epidemic. However, high dropout rates from medication remain a challenge. Behavioral treatment with contingency management and cognitive behavioral counseling has shown promise for improving the outcomes of buprenorphine treatment but is complicated to deliver. The delivery of behavioral treatment through technology-based platforms has the potential to make it more feasible for widespread dissemination. Objective: reSET-O is a prescription digital therapeutic and a commercial adaptation of the Therapeutic Education System, an internet-based program with a Community Reinforcement Approach to cognitive behavioral therapy. It delivers cognitive behavioral therapy modules and contingency management rewards upon completion of modules and negative urine drug screens. This pilot study aims to assess the feasibility and acceptability of reSET-O in a community-based opioid treatment program with a Hub and Spoke model of care as part of a larger strategy to maintain individuals in treatment. Objective and qualitative results, as well as acceptability and likeability of reSET-O, were obtained from 15 individuals. Methods: English-speaking individuals aged ≥18 years with a diagnosis of current opioid use disorder were recruited after being on buprenorphine for at least 1 week of treatment. Two 12-week prescriptions for reSET-O were written for the 24-week study. Patient reports of drug use and likeability scales of reSET-O were conducted at weeks 4, 8, 12, and 24 of the study. Qualitative interviews were also conducted. A total of 4 providers were recruited and provided feedback on the acceptability and feasibility of reSET-O. Results: Of the 15 participants who participated in this pilot study, 7 (47%) completed 24 weeks, and 8 (53%) were unable to complete because of dropout after enrollment, attrition in treatment, or incarceration. An average of US $96 in contingency management rewards were earned by participants for the completion of modules for the duration of the pilot study. Participants’ subjective feedback revealed that reSET-O was easy to use, enjoyable, and helped provide a safe space to admit recurring substance use. Conclusions: reSET-O was well accepted based on patient and provider feedback in this pilot study; however, adherence and retention in treatment remain areas for improvement. Randomized control trials are needed to assess whether retention of community-based buprenorphine treatment is enhanced through the use of technology-based behavioral interventions such as reSET-O. %M 35333189 %R 10.2196/33073 %U https://formative.jmir.org/2022/3/e33073 %U https://doi.org/10.2196/33073 %U http://www.ncbi.nlm.nih.gov/pubmed/35333189 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e29384 %T Internet-Delivered Cognitive Behavioral Therapy for Generalized Anxiety Disorder in Nationwide Routine Care: Effectiveness Study %A Ritola,Ville %A Lipsanen,Jari Olavi %A Pihlaja,Satu %A Gummerus,Eero-Matti %A Stenberg,Jan-Henry %A Saarni,Suoma %A Joffe,Grigori %+ Department of Psychiatry, Helsinki University Hospital and University of Helsinki, P.O. Box 100, Helsinki, 00029 HUS, Finland, 358 405136500, grigori.joffe@hus.fi %K CBT %K iCBT %K cognitive behavioral therapy %K routine care %K generalized anxiety disorder %K internet %K web-based %K digital health %K mental health %D 2022 %7 24.3.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Therapist-supported, internet-delivered cognitive behavioral therapy (iCBT) is efficacious for generalized anxiety disorder (GAD), but few studies are yet to report its effectiveness in routine care. Objective: In this study, we aim to examine whether a new 12-session iCBT program for GAD is effective in nationwide routine care. Methods: We administered a specialized, clinic-delivered, therapist-supported iCBT for GAD in 1099 physician-referred patients. The program was free of charge for patients, and the completion time was not predetermined. We measured symptoms with web-based questionnaires. The primary measure of anxiety was the GAD 7-item scale (GAD-7); secondary measures were, for pathological worry, the Penn State Worry Questionnaire and, for anxiety and impairment, the Overall Anxiety Severity and Impairment Scale. Results: Patients completed a mean 7.8 (SD 4.2; 65.1%) of 12 sessions, and 44.1% (485/1099) of patients completed all sessions. The effect size in the whole sample for GAD-7 was large (Cohen d=0.97, 95% CI 0.88-1.06). For completers, effect sizes were very large (Cohen d=1.34, 95% CI 1.25-1.53 for GAD-7; Cohen d=1.14, 95% CI 1.00-1.27 for Penn State Worry Questionnaire; and Cohen d=1.23, 95% CI 1.09-1.37 for Overall Anxiety Severity and Impairment Scale). Noncompleters also benefited from the treatment. Greater symptomatic GAD-7–measured relief was associated with more completed sessions, older age, and being referred from private or occupational care. Of the 894 patients with a baseline GAD-7 score ≥10, approximately 421 (47.1%) achieved reliable recovery. Conclusions: This nationwide, free-of-charge, therapist-supported HUS Helsinki University Hospital–iCBT for GAD was effective in routine care, but further research must establish effectiveness against other treatments and optimize the design of iCBT for GAD for different patient groups and individual patients. %M 35323119 %R 10.2196/29384 %U https://www.jmir.org/2022/3/e29384 %U https://doi.org/10.2196/29384 %U http://www.ncbi.nlm.nih.gov/pubmed/35323119 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e25906 %T The Effectiveness of Physical Activity-Promoting Web- and Mobile-Based Distance Weight Loss Interventions on Body Composition in Rehabilitation Settings: Systematic Review, Meta-analysis, and Meta-Regression Analysis %A Lahtio,Heli %A Rintala,Aki %A Immonen,Jaakko %A Sjögren,Tuulikki %+ Faculty of Sport and Health Sciences, The University of Jyväskylä, Keskussairaalantie 4, Jyväskylä, 40014, Finland, 358 14 260 1211, heli.lahtio@gmail.com %K technology %K weight loss %K rehabilitation %K overweight %K obesity %K body mass index %K waist circumference %K body fat percentage %K mobile phone %D 2022 %7 24.3.2022 %9 Review %J J Med Internet Res %G English %X Background: Overweight and obesity are major problems worldwide, and they lead to an increased risk for several diseases. The use of technology in the treatment of obesity is promising, but in the existing literature, there is considerable uncertainty regarding its efficacy. In this review, we included web- and mobile-based weight loss interventions that were implemented remotely in rehabilitation settings. Objective: The aim of this systematic review is to study the effectiveness of physical activity-promoting web- and mobile-based distance weight loss interventions in rehabilitation settings on body composition in comparison with control groups that did not use technology. Methods: Studies were searched from 9 databases. The inclusion criteria were as follows: population: age 18-65 years; intervention: physical activity-promoting web- and mobile-based distance weight loss interventions; comparison: control groups without the use of technology; outcome: changes in BMI, waist circumference, or body fat percentage; study design: randomized controlled trial. The quality of the studies was assessed by 2 researchers. Meta-analysis was performed, and we also conducted a meta-regression analysis to evaluate the factors associated with the changes in body composition outcomes if statistical heterogeneity was observed. Results: The meta-analysis included 30 studies. The mean quality of the studies was 7 of 13 (SD 1.9; range 3-10). A statistically significant difference was observed in BMI (mean difference [MD] 0.83, 95% CI 0.51-1.15 kg/m2; P<.001), waist circumference (MD 2.45, 95% CI 1.83-3.07 cm; P<.001), and body fat percentage (MD 1.07%, 95% CI 0.74%-1.41%; P<.001) in favor of the weight loss groups using web- or mobile-based interventions. Meta-regression analyses found an association between personal feedback and BMI (P=.04), but other factors did not play a role in explaining statistical heterogeneity. Conclusions: Web- and mobile-based distance weight loss interventions significantly reduced BMI, waist circumference, and body fat percentage. Future studies should focus on the comparability of the intervention content. Future studies are needed to better understand weight loss and identify which components are essential in achieving it. Trial Registration: PROSPERO CRD42016035831; https://tinyurl.com/7c93tvd4 %M 35323126 %R 10.2196/25906 %U https://www.jmir.org/2022/3/e25906 %U https://doi.org/10.2196/25906 %U http://www.ncbi.nlm.nih.gov/pubmed/35323126 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e33852 %T Effect of Information and Communication Technology–Based Self-management System DialBeticsLite on Treating Abdominal Obesity in the Specific Health Guidance in Japan: Randomized Controlled Trial %A Kondo,Masahiro %A Okitsu,Teru %A Waki,Kayo %A Yamauchi,Toshimasa %A Nangaku,Masaomi %A Ohe,Kazuhiko %+ Department of Biomedical Informatics, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8654, Japan, 81 3 5800 9129, kwaki-tky@m.u-tokyo.ac.jp %K mHealth %K smartphone app %K abdominal obesity %K self-management %K telemedicine %K digital health %K app %K obesity %K overweight %K weight %K randomized controlled trial %K intervention %K lifestyle %K behavior %K mobile phone %D 2022 %7 24.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Mobile health (mHealth) interventions, a more cost-effective approach compared with traditional methods of delivering lifestyle coaching in person, have been shown to improve physical parameters and lifestyle behavior among overweight populations. In Japan, the Specific Health Checkups and Specific Health Guidance (SHG) started in 2008 to treat obesity and abdominal obesity. However, the effectiveness of SHG is limited owing to its in-person counseling. The effect of mHealth on SHG has yet to be demonstrated. Objective: This study aims to determine whether a mobile self-management app (DialBeticsLite) could make the SHG more beneficial among patients with abdominal obesity to achieve a reduction in visceral fat area (VFA). Methods: This study was an open-label, 2-arm, parallel-design randomized controlled trial. We recruited 122 people in September 2017 and randomly assigned them into either the intervention or control group. All participants attended an educational group session that delivered information regarding diet and exercise. In addition, participants in the intervention group were asked to use DialBeticsLite for 3 months. DialBeticsLite facilitated the daily recording of several physical parameters and lifestyle behavior and provided feedback to encourage an improvement in behavior. The primary outcome was the change in VFA from baseline to the 3-month follow-up. Secondary outcomes included changes in both physical and metabolic parameters from baseline to the 3-month follow-up. The Welch 2-tailed t test was conducted to analyze the effects of DialBeticsLite on both the primary and secondary outcomes. Results: Of the 122 participants recruited, 75 (61.5%) were analyzed because 47 (38.5%) were excluded: 37 (30.3%) because of ineligibility and 10 (8.2%) because of withdrawal of consent. The mean age was 49.3 (SD 6.1) years in the intervention group (41/75, 55%) and 48.5 (SD 5.3) years in the control group (34/75, 45%), and all participants were men, although unintentionally. The baseline characteristics did not differ significantly between the intervention and control groups, except for VFA. The average change of VFA was −23.5 (SD 20.6) cm2 in the intervention group and +1.9 (SD 16.2) cm2 in the control group (P<.001). Statistically significant differences were also found for the change of body weight, BMI, and waist circumference. These findings did not change after adjusting for VFA at the baseline. The intervention had no significant effect on any of the metabolic parameters. An exploratory analysis showed significant associations between the change in VFA and steps per day and between the change in VFA and calorie intake per day within the intervention group. Conclusions: Our findings indicate that an mHealth intervention facilitating the daily monitoring of several physical parameters and lifestyle behavior can be highly effective in inducing visceral fat loss and weight loss among adults eligible for SHG. Trial Registration: UMIN Clinical Trials Registry UMIN000042045; https://tinyurl.com/4vat3v53 %M 35323122 %R 10.2196/33852 %U https://formative.jmir.org/2022/3/e33852 %U https://doi.org/10.2196/33852 %U http://www.ncbi.nlm.nih.gov/pubmed/35323122 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e31831 %T Review of Mobile Apps for Women With Anxiety in Pregnancy: Maternity Care Professionals’ Guide to Locating and Assessing Anxiety Apps %A Evans,Kerry %A Donelan,Jasper %A Rennick-Egglestone,Stefan %A Cox,Serena %A Kuipers,Yvonne %+ School of Health Sciences, University of Nottingham, Medical School, Queen's Medical Centre, Nottingham, NG7 2HA, United Kingdom, 44 115 95 15559, kerry.evans1@nottingham.ac.uk %K anxiety %K pregnancy %K antenatal %K mobile applications %K digital interventions %K mHealth %K mobile app %K psychological well-being %K maternity %K evaluation %K quality assessment %D 2022 %7 23.3.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Mental health and pregnancy apps are widely available and have the potential to improve health outcomes and enhance women’s experience of pregnancy. Women frequently access digital information throughout their pregnancy. However, health care providers and women have little information to guide them toward potentially helpful or effective apps. Objective: This review aimed to evaluate a methodology for systematically searching and reviewing commercially available apps that support pregnant women with symptoms of anxiety in order to assist maternity care professionals in identifying resources that they could recommend for these women. Methods: A stepwise systematic approach was used to identify, select, describe, and assess the most popular and highly user-rated apps available in the United Kingdom from January to March 2021. This included developing a script-based search strategy and search process, writing evaluation criteria, and conducting a narrative description and evaluation of the selected apps. Results: Useful search terms were identified, which included nonclinical, aspirational, and problem-based phrases. There were 39 apps selected for inclusion in the review. No apps specifically targeted women with anxiety in pregnancy. Of the 39 apps included in the review, 33 (85%) focused solely on mind-body techniques to promote relaxation, stress reduction, and psychological well-being. Only 8 of the 39 (21%) apps included in the review reported that health care professionals had contributed to app development and only 1/39 (3%) provided empirical evidence on the effectiveness and acceptability of the app. The top 12/39 (31%) apps were evaluated by 2 independent reviewers using the developed criteria and scores. There was a small negative correlation between the reviewers’ scores and app user rating scores, with higher user rating scores associated with lower reviewer scores. Conclusions: App developers, publishers, and maternity care professionals should seek advice from women with lived experience of anxiety symptoms in pregnancy to locate, promote, and optimize the visibility of apps for pregnant women. There is a lack of resources that provide coping strategies based on current evidence for the treatment of anxiety in pregnancy. Maternity care providers are limited in their ability to locate and recommend acceptable and trustworthy apps because of the lack of information on the evidence base, development, and testing of apps. Maternity care professionals and women need access to libraries of trusted apps that have been evaluated against relevant and established criteria. %M 35319482 %R 10.2196/31831 %U https://www.jmir.org/2022/3/e31831 %U https://doi.org/10.2196/31831 %U http://www.ncbi.nlm.nih.gov/pubmed/35319482 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e28927 %T Digital Assessment Tools Using Animation Features to Quantify Alcohol Consumption: Systematic App Store and Literature Review %A Wiemker,Veronika %A Neufeld,Maria %A Bunova,Anna %A Danquah,Ina %A Ferreira-Borges,Carina %A Konigorski,Stefan %A Rastogi,Ankit %A Probst,Charlotte %+ Heidelberg Institute of Global Health, Medical Faculty and University Hospital, Heidelberg University, Im Neuenheimer Feld 130.3, Heidelberg, 69120, Germany, 49 6221 56 5040, charlotte.probst@uni-heidelberg.de %K alcohol consumption %K harmful and hazardous drinking %K screening %K assessment methods %K eHealth %K mobile apps %K visualization %K animation features %K AUDIT %K primary health care %D 2022 %7 23.3.2022 %9 Review %J J Med Internet Res %G English %X Background: Accurate and user-friendly assessment tools for quantifying alcohol consumption are a prerequisite for effective interventions to reduce alcohol-related harm. Digital assessment tools (DATs) that allow the description of consumed alcoholic drinks through animation features may facilitate more accurate reporting than conventional approaches. Objective: This review aims to identify and characterize freely available DATs in English or Russian that use animation features to support the quantitative assessment of alcohol consumption (alcohol DATs) and determine the extent to which such tools have been scientifically evaluated in terms of feasibility, acceptability, and validity. Methods: Systematic English and Russian searches were conducted in iOS and Android app stores and via the Google search engine. Information on the background and content of eligible DATs was obtained from app store descriptions, websites, and test completions. A systematic literature review was conducted in Embase, MEDLINE, PsycINFO, and Web of Science to identify English-language studies reporting the feasibility, acceptability, and validity of animation-using alcohol DATs. Where possible, the evaluated DATs were accessed and assessed. Owing to the high heterogeneity of study designs, results were synthesized narratively. Results: We identified 22 eligible alcohol DATs in English, 3 (14%) of which were also available in Russian. More than 95% (21/22) of tools allowed the choice of a beverage type from a visually displayed selection. In addition, 36% (8/22) of tools enabled the choice of a drinking vessel. Only 9% (2/22) of tools allowed the simulated interactive pouring of a drink. For none of the tools published evaluation studies were identified in the literature review. The systematic literature review identified 5 exploratory studies evaluating the feasibility, acceptability, and validity of 4 animation-using alcohol DATs, 1 (25%) of which was available in the searched app stores. The evaluated tools reached moderate to high scores on user rating scales and showed fair to high convergent validity when compared with established assessment methods. Conclusions: Animation-using alcohol DATs are available in app stores and on the web. However, they often use nondynamic features and lack scientific background information. Explorative study data suggest that such tools might enable the user-friendly and valid assessment of alcohol consumption and could thus serve as a building block in the reduction of alcohol-attributable health burden worldwide. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020172825; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020172825 %M 35319472 %R 10.2196/28927 %U https://www.jmir.org/2022/3/e28927 %U https://doi.org/10.2196/28927 %U http://www.ncbi.nlm.nih.gov/pubmed/35319472 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e31449 %T Social Media–Delivered Patient Education to Enhance Self-management and Attitudes of Patients with Type 2 Diabetes During the COVID-19 Pandemic: Randomized Controlled Trial %A Leong,Cheng Man %A Lee,Ting-I %A Chien,Yu-Mei %A Kuo,Li-Na %A Kuo,Yu-Feng %A Chen,Hsiang-Yin %+ Department of Clinical Pharmacy, School of Pharmacy, Taipei Medical University, R714, 7th Floor, Health and Science Building, No.250, Wuxing St., Xinyi Dist., Taipei, 110, Taiwan, 886 2 2736 1661 ext 6175, shawn@tmu.edu.tw %K diabetes %K COVID-19 %K education %K video %K social media %K health literacy %K self-care activity %K type 2 diabetes %K attitude %K mHealth %D 2022 %7 23.3.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The use of mobile health technologies has been necessary to deliver patient education to patients with diabetes during the COVID-19 pandemic. Objective: This open-label randomized controlled trial evaluated the effects of a diabetes educational platform—Taipei Medical University–LINE Oriented Video Education—delivered through a social media app. Methods: Patients with type 2 diabetes were recruited from a clinic through physician referral. The social media–based program included 51 videos: 10 about understanding diabetes, 10 about daily care, 6 about nutrition care, 21 about diabetes drugs, and 4 containing quizzes. The intervention group received two or three videos every week and care messages every 2 weeks through the social media platform for 3 months, in addition to usual care. The control group only received usual care. Outcomes were measured at clinical visits through self-reported face-to-face questionnaires at baseline and at 3 months after the intervention, including the Simplified Diabetes Knowledge Scale (true/false version), the Diabetes Care Profile–Attitudes Toward Diabetes Scales, the Summary of Diabetes Self-Care Activities, and glycated hemoglobin (HbA1c) levels. Health literacy was measured at baseline using the Newest Vital Sign tool. Differences in HbA1c levels and questionnaire scores before and after the intervention were compared between groups. The associations of knowledge, attitudes, and self-care activities with health literacy were assessed. Results: Patients with type 2 diabetes completed the 3-month study, with 91 out of 181 (50.3%) patients in the intervention group and 90 (49.7%) in the control group. The change in HbA1c did not significantly differ between groups (intervention group: mean 6.9%, SD 0.8% to mean 7.0%, SD 0.9%, P=.34; control group: mean 6.7%, SD 0.6% to mean 6.7%, SD 0.7%, P=.91). Both groups showed increased mean knowledge scores at 12 weeks, increasing from 68.3% (SD 16.4%) to 76.7% (SD 11.7%; P<.001) in the intervention group and from 64.8% (SD 18.2%) to 73.2% (SD 12.6%; P<.001) in the control group. Positive improvements in attitudes and self-care activities were only observed in the intervention group (attitudes: mean difference 0.2, SD 0.5, P=.001; self-care activities: mean difference 0.3, SD 1.2, P=.03). A 100% utility rate was achieved for 8 out of 21 (38%) medication-related videos. Low health literacy was a significant risk factor for baseline knowledge scores in the intervention group, with an odds ratio of 2.80 (95% CI 1.28-6.12; P=.01); this became insignificant after 3 months. Conclusions: The social media–based program was effective at enhancing the knowledge, attitudes, and self-care activities of patients with diabetes. This intervention was also helpful for patients with low health literacy in diabetes knowledge. The program represents a potentially useful tool for delivering diabetes education to patients through social media, especially during the COVID-19 pandemic. Trial Registration: ClinicalTrials.gov NCT04876274; https://clinicaltrials.gov/ct2/show/results/NCT04876274 %M 35319478 %R 10.2196/31449 %U https://www.jmir.org/2022/3/e31449 %U https://doi.org/10.2196/31449 %U http://www.ncbi.nlm.nih.gov/pubmed/35319478 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 3 %P e32212 %T Web-Based Versus Print-Based Physical Activity Intervention for Community-Dwelling Older Adults: Crossover Randomized Trial %A Pischke,Claudia R %A Voelcker-Rehage,Claudia %A Ratz,Tiara %A Peters,Manuela %A Buck,Christoph %A Meyer,Jochen %A von Holdt,Kai %A Lippke,Sonia %+ Institute of Medical Sociology, Centre for Health and Society, Medical Faculty, Heinrich Heine University Duesseldorf, Moorenstrasse 5, Duesseldorf, 40225, Germany, 49 211 81 ext 08599, ClaudiaRuth.Pischke@med.uni-duesseldorf.de %K physical activity %K older adults %K eHealth %K print-based intervention %K web-based intervention %K physical activity promotion %K healthy aging %K preferences %K randomized trial %K mobile phone %D 2022 %7 23.3.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Fewer than half of older German adults engage in the recommended levels of endurance training. Objective: The study aim is to compare the acceptance and effectiveness of two interventions for physical activity (PA) promotion among initially inactive community-dwelling older adults ≥60 years in a 9-month, crossover randomized trial. Methods: Participants were recruited in person and randomized to one of the following interventions for self-monitoring PA: a print-based intervention (PRINT: 113/242, 46.7%) or a web-based intervention (WEB: 129/242, 53.3%). Furthermore, 29.5% (38/129) of those in the web-based intervention group received a PA tracker in addition to WEB (WEB+). After randomization, the participants and researchers were not blinded. The participants’ baseline intervention preferences were retrospectively assessed. All the intervention groups were offered 10 weekly face-to-face group sessions. Afterward, participants could choose to stay in their group or cross over to one of the other groups, and group sessions were continued monthly for another 6 months. 3D accelerometers to assess PA and sedentary behavior (SB) at baseline (T0), 3-month follow-up (T1), and 9-month follow-up (T2) were used. Adherence to PA recommendations, attendance of group sessions, and intervention acceptance were assessed using self-administered paper-based questionnaires. Linear mixed models were used to calculate differences in moderate to vigorous PA (MVPA) and SB between time points and intervention groups. Results: Of the 242 initially recruited participants, 91 (37.6%) were randomized to the WEB group; 38 (15.7%) to the WEB+ group; and 113 (46.7%) to the PRINT group. Overall, 80.6% (195/242) of the participants completed T1. Only 0.4% (1/242) of the participants changed from the WEB group to the PRINT group and 6.2% (15/242) moved from the PRINT group to the WEB group (WEB-WEB: 103/249, (41.4%); PRINT-PRINT: 76/249, 30.5%) when offered to cross over at T1. Furthermore, 66.1% (160/242) of participants completed T2. MVPA in minutes per day increased between baseline and T1, but these within-group changes disappeared after adjusting for covariates. MVPA decreased by 9 minutes per day between baseline and T2 (βtime=−9.37, 95% CI −18.58 to −0.16), regardless of the intervention group (WEB vs PRINT: βgroup*time=−3.76, 95% CI −13.33 to 5.82, WEB+ vs PRINT: βgroup*time=1.40, 95% CI −11.04 to 13.83). Of the participants, 18.6% (38/204) met the PA recommendations at T0, 16.4% (26/159) at T1, and 20.3% (28/138) at T2. For SB, there were no significant group differences or group-by-time interactions at T1 or T2. Intervention acceptance was generally high. The use of intervention material was high to moderate at T1 and decreased by T2. Conclusions: There was little movement between intervention groups at T1 when given the choice, and participation was not associated with increases in PA or decreases in SB over time. Trial Registration: German Clinical Trials Register DRKS00016073; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00016073 %M 35319484 %R 10.2196/32212 %U https://mhealth.jmir.org/2022/3/e32212 %U https://doi.org/10.2196/32212 %U http://www.ncbi.nlm.nih.gov/pubmed/35319484 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 1 %P e34294 %T Patients’ Experiences of Using a Smartphone App After Cardiac Rehabilitation: Qualitative Study %A Lunde,Pernille %A Bye,Asta %A Bruusgaard,Kari Anette %A Hellem,Elisabet %A Nilsson,Birgitta Blakstad %+ Department of Physiotherapy, Faculty of Health Sciences, Oslo Metropolitan University, PB 4, St. Olavs Plass, Oslo, 0130, Norway, 47 48063537, plunde@oslomet.no %K mHealth %K mobile health %K cardiac rehabilitation %K mobile phone app %K smartphone %K lifestyle %D 2022 %7 23.3.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Exercise-based cardiac rehabilitation (CR) is a crucial part of the treatment of patients with cardiac diseases, and adherence to healthy behavior is a prerequisite to improve long-term prognosis. Unfortunately, adherence to healthy behavior adapted in CR is challenging for many cardiac patients in the long term. Recently, we demonstrated that follow-up conducted via an app for 1 year significantly improved adherence to healthy behavior after CR. To increase the knowledge and understanding of mobile Health (mHealth) interventions that can promote acceptance and adherence, qualitative research investigating patients’ experiences with these interventions is warranted. Objective: The aim was to investigate patient experiences with individualized long-term follow-up conducted via an app for 1 year and their thoughts about what features promoted adherence to healthy behavior after CR. The purpose was to increase the understanding of significant findings previously reported and to guide future development of similar interventions in the field of adherence. Methods: A qualitative study with individual interviews was conducted from November 2018 to May 2019. A thematic interview guide was used when conducting the semistructured in-depth interviews. The interviews were audio recorded and transcribed successively during the period in which the interviews were conducted. Texts were managed and systematized by NVivo. Interviews were analyzed by qualitative content analysis. Codes and themes were inductively developed. Results: Ten patients who had participated in a randomized controlled trial evaluating the effect of follow-up conducted via an app on adherence to healthy behavior after CR were included. The median patient age was 65 years (range 46-72 years), and both genders were represented. The analysis resulted in the following 4 themes describing the patients’ experiences: (1) The person behind the app is crucial for motivation and adherence; (2) The app as a commitment; (3) The app as a path to independence; and (4) Suggestions for improvements. Features experienced as beneficial to promote adherence were individualized feedback and the use of goal setting. The significance of the person behind the app (the supervisor) who provided individualized feedback was a consistent finding. This person seemed to promote motivation in general and to enable other known behavioral change techniques. Conclusions: The person behind the app (the supervisor) seems to be one of the most significant success factors in promoting adherence to healthy behavior after CR. This indicates that a health care provider must actively participate in a patient’s process of adherence to healthy behavior, even when using interventions, including an app. Future development of interventions in the field of adherence should strive to create tools that enable an ongoing collaborative relationship between the patient and the health care provider. The follow-up should be based on the patient’s own goals, and individualized feedback should be provided. %M 35319476 %R 10.2196/34294 %U https://humanfactors.jmir.org/2022/1/e34294 %U https://doi.org/10.2196/34294 %U http://www.ncbi.nlm.nih.gov/pubmed/35319476 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e24725 %T Clinical Outcomes Among Working Adults Using the Health Integrator Smartphone App: Analyses of Prespecified Secondary Outcomes in a Randomized Controlled Trial %A Bonn,Stephanie %A Licitra,Gabriella %A Bellocco,Rino %A Trolle Lagerros,Ylva %+ Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, T2, Karolinska University Hospital, Stockholm, 171 76, Sweden, 46 08 51779173, stephanie.bonn@ki.se %K adults %K body composition %K exercise %K HbA1c %K healthy lifestyle %K metabolic health %K mobile app %K randomized controlled trial %K smartphone %D 2022 %7 21.3.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: There is a need to find new methods that can enhance the individuals’ engagement in self-care and increase compliance to a healthy lifestyle for the prevention of noncommunicable diseases and improved quality of life. Mobile health (mHealth) apps could provide large-scale, cost-efficient digital solutions to implement lifestyle change, which as a corollary may enhance quality of life. Objective: Here we evaluate if the use of a smartphone-based self-management system, the Health Integrator app, with or without telephone counseling by a health coach, had an effect on clinical variables (secondary outcomes) of importance for noncommunicable diseases. Methods: The study was a 3-armed parallel randomized controlled trial. Participants were randomized to a control group or to 1 of 2 intervention groups using the Health Integrator app with or without additional telephone counseling for 3 months. Clinical variables were assessed before the start of the intervention (baseline) and after 3 months. Due to the nature of the intervention, targeting lifestyle changes, participants were not blinded to their allocation. Robust linear regression with complete case analysis was performed to study the intervention effect among the intervention groups, both in the entire sample and stratifying by type of work (office worker vs bus driver) and sex. Results: Complete data at baseline and follow-up were obtained from 205 and 191 participants, respectively. The mean age of participants was 48.3 (SD 10) years; 61.5% (126/205) were men and 52.2% (107/205) were bus drivers. Improvements were observed at follow-up among participants in the intervention arms. There was a small statistically significant effect on waist circumference (β=–0.97, 95% CI –1.84 to –0.10) in the group receiving the app and additional coach support compared to the control group, but no other statistically significant differences were seen. However, participants receiving only the app had statistically significantly lower BMI (β=–0.35, 95% CI –0.61 to –0.09), body weight (β=–1.08, 95% CI –1.92 to –0.26), waist circumference (β=–1.35, 95% CI –2.24 to –0.45), and body fat percentage (β=–0.83, 95% CI –1.65 to –0.02) at follow-up compared to the controls. There was a statistically significant difference in systolic blood pressure between the two intervention groups at follow-up (β=–3.74, 95% CI –7.32 to –0.16); no other statistically significant differences in outcome variables were seen. Conclusions: Participants randomized to use the Health Integrator smartphone app showed small but statistically significant differences in body weight, BMI, waist circumference, and body fat percentage compared to controls after a 3-month intervention. The effect of additional coaching together with use of the app is unclear. Trial Registration: ClinicalTrials.gov NCT03579342; https://clinicaltrials.gov/ct2/show/NCT03579342 International Registered Report Identifier (IRRID): RR2-10.1186/s12889-019-6595-6 %M 35311677 %R 10.2196/24725 %U https://www.jmir.org/2022/3/e24725 %U https://doi.org/10.2196/24725 %U http://www.ncbi.nlm.nih.gov/pubmed/35311677 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e30231 %T Effect of Sleep Disturbance Symptoms on Treatment Outcome in Blended Cognitive Behavioral Therapy for Depression (E-COMPARED Study): Secondary Analysis %A Jensen,Esben Skov %A Ladegaard,Nicolai %A Mellentin,Angelina Isabella %A Ebert,David Daniel %A Titzler,Ingrid %A Araya,Ricardo %A Cerga Pashoja,Arlinda %A Hazo,Jean-Baptiste %A Holtzmann,Jérôme %A Cieslak,Roman %A Smoktunowicz,Ewelina %A Baños,Rosa %A Herrero,Rocio %A García-Palacios,Azucena %A Botella,Cristina %A Berger,Thomas %A Krieger,Tobias %A Holmberg,Trine Theresa %A Topooco,Naira %A Andersson,Gerhard %A van Straten,Annemieke %A Kemmeren,Lise %A Kleiboer,Annet %A Riper,Heleen %A Mathiasen,Kim %+ Centre for Telepsychiatry, Mental Health Services of Southern Denmark, Odense, Denmark, 1 61677747, kmathiasen@health.sdu.dk %K blended care %K bCBT %K cognitive behavioral therapy %K digital intervention %K major depressive disorder %K sleep disturbance %K sleep disorder %K mental health %K digital health %K mobile phone %D 2022 %7 21.3.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Sleep disturbance symptoms are common in major depressive disorder (MDD) and have been found to hamper the treatment effect of conventional face-to-face psychological treatments such as cognitive behavioral therapy. To increase the dissemination of evidence-based treatment, blended cognitive behavioral therapy (bCBT) consisting of web-based and face-to-face treatment is on the rise for patients with MDD. To date, no study has examined whether sleep disturbance symptoms have an impact on bCBT treatment outcomes and whether it affects bCBT and treatment-as-usual (TAU) equally. Objective: The objectives of this study are to investigate whether baseline sleep disturbance symptoms have an impact on treatment outcomes independent of treatment modality and whether sleep disturbance symptoms impact bCBT and TAU in routine care equally. Methods: The study was based on data from the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment Versus Treatment-as-Usual) study, a 2-arm, multisite, parallel randomized controlled, noninferiority trial. A total of 943 outpatients with MDD were randomized to either bCBT (476/943, 50.5%) or TAU consisting of routine clinical MDD treatment (467/943, 49.5%). The primary outcome of this study was the change in depression symptom severity at the 12-month follow-up. The secondary outcomes were the change in depression symptom severity at the 3- and 6-month follow-up and MDD diagnoses at the 12-month follow-up, assessed using the Patient Health Questionnaire-9 and Mini-International Neuropsychiatric Interview, respectively. Mixed effects models were used to examine the association of sleep disturbance symptoms with treatment outcome and treatment modality over time. Results: Of the 943 patients recruited for the study, 558 (59.2%) completed the 12-month follow-up assessment. In the total sample, baseline sleep disturbance symptoms did not significantly affect change in depressive symptom severity at the 12-month follow-up (β=.16, 95% CI –0.04 to 0.36). However, baseline sleep disturbance symptoms were negatively associated with treatment outcome for bCBT (β=.49, 95% CI 0.22-0.76) but not for TAU (β=–.23, 95% CI −0.50 to 0.05) at the 12-month follow-up, even when adjusting for baseline depression symptom severity. The same result was seen for the effect of sleep disturbance symptoms on the presence of depression measured with Mini-International Neuropsychiatric Interview at the 12-month follow-up. However, for both treatment formats, baseline sleep disturbance symptoms were not associated with depression symptom severity at either the 3- (β=.06, 95% CI −0.11 to 0.23) or 6-month (β=.09, 95% CI −0.10 to 0.28) follow-up. Conclusions: Baseline sleep disturbance symptoms may have a negative impact on long-term treatment outcomes in bCBT for MDD. This effect was not observed for TAU. These findings suggest that special attention to sleep disturbance symptoms might be warranted when MDD is treated with bCBT. Future studies should investigate the effect of implementing modules specifically targeting sleep disturbance symptoms in bCBT for MDD to improve long-term prognosis. %M 35311687 %R 10.2196/30231 %U https://www.jmir.org/2022/3/e30231 %U https://doi.org/10.2196/30231 %U http://www.ncbi.nlm.nih.gov/pubmed/35311687 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 3 %P e31040 %T Comparing Reminders Sent via SMS Text Messaging and Email for Improving Adherence to an Electronic Health Program: Randomized Controlled Trial %A Kulhánek,Adam %A Lukavska,Katerina %A Gabrhelík,Roman %A Novák,Daniel %A Burda,Václav %A Prokop,Jindřich %A Holter,Marianne T S %A Brendryen,Håvar %+ Department of Addictology, General University Hospital in Prague, Apolinářská 4, Prague, 12000, Czech Republic, 420 224 968 273, katerina.lukavska@lf1.cuni.cz %K eHealth %K randomized controlled trial %K adherence %K reminders %K SMS text messaging %K email %K smoking cessation %K text message %D 2022 %7 18.3.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: eHealth interventions can help people change behavior (eg, quit smoking). Reminders sent via SMS text messaging or email may improve the adherence to web-based programs and increase the probability of successful behavior change; however, it is unclear whether their efficiency is affected by the modality of the communication channel. Objective: A 2-armed randomized control trial was conducted to compare the effect of providing reminders via SMS text messaging versus email on the adherence to an eHealth program for smoking cessation and on the probability to initiate a quit attempt. Methods: Smokers were recruited via an internet-based advertisement. A total of 591 participants who diverted from intended use of the program (ie, failed to log on to a session) were automatically randomized to the experimental (SMS text messaging reminder, n=304) or the active comparator (email reminder, n=287) group. Results: Unexpectedly, we found that the mode of reminder delivery did not significantly affect either the adherence, namely the number of completed program sessions, with the SMS text messaging reminder group showing a mean of 4.30 (SD 3.24) and the email reminder group showing a mean of 4.36 (SD 3.27) (t586=0.197, P=.84, and Cohen d=0.016), or the outcome, namely the quit smoking attempt rate (34.2% in the SMS text messaging group vs 31.7% in the email group; χ21=0.4, P=.52). Secondary analyses showed that age, gender, and education had significant effects on program adherence and education on the outcome. Moreover, we found a significant interaction effect between the mode of reminder delivery and gender on program adherence, suggesting that the effectiveness of SMS text message reminders might be different for females and males. However, this particular finding should be treated with care as it was based on post hoc subgroup analysis. Conclusions: This study indicates that the modality of user reminders to log on increased neither the program adherence nor the probability of quitting smoking. This suggests that program developers may save costs using emails instead of SMS text messaging reminders. Trial Registration: ClinicalTrials.gov NCT03276767; https://clinicaltrials.gov/ct2/show/ NCT03276767 %M 35302945 %R 10.2196/31040 %U https://mhealth.jmir.org/2022/3/e31040 %U https://doi.org/10.2196/31040 %U http://www.ncbi.nlm.nih.gov/pubmed/35302945 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 3 %P e32123 %T The Effectiveness of a Nonguided Mindfulness App on Perceived Stress in a Nonclinical Dutch Population: Randomized Controlled Trial %A Kranenburg,Leonieke W %A Gillis,Jamie %A Mayer,Birgit %A Hoogendijk,Witte J G %+ Section of Medical Psychology, Department of Psychiatry, Erasmus University Medical Center, PO Box 2040, Rotterdam, 3000 CA, Netherlands, 31 10 7040139, l.kranenburg@erasmusmc.nl %K mHealth %K mindfulness %K stress %K burnout %K non-clinical population %K nonclinical %D 2022 %7 18.3.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Mindfulness has become increasingly popular, and positive outcomes have been reported for mindfulness-based interventions (MBIs) in reducing stress. These findings make room for innovative perspectives on how MBIs could be applied, for instance through mobile health (mHealth). Objective: The aim of this study is to investigate whether a nonguided mindfulness mobile app can decrease perceived stress in a nonclinical Dutch population over the course of 8 weeks, with follow-up at 6 months. Methods: A randomized controlled trial was performed to compare an experimental group that made use of a structured 8-week mHealth mindfulness program and a control group after 8 weeks, with follow-up after 6 months. Participants were recruited via a national television program. The primary outcome measure was perceived stress as measured by the Perceived Stress Scale, secondary outcomes were symptoms of burnout (measured using the visual analog scale [VAS]) and psychological symptoms (measured using the Four-Dimensional Symptom Questionnaire [4DSQ] at follow-up). Outcomes were analyzed using a multilevel regression model. Results: At baseline, 587 respondents were included. Results showed no postintervention differences between groups for the level of perceived stress. With regard to the secondary outcome measures, the VAS for emotional exhaustion and physical exhaustion showed significantly lower scores for the experimental group after 8 weeks (P=.04 and P=.01, respectively), but not at follow-up. There were no differences between groups for psychological symptoms measured using the 4DSQ. Conclusions: These findings do not support our hypothesis that using the mindfulness app would reduce stress levels. However, our findings related to diminished exhaustion at 8 weeks are encouraging and require further investigation. Trial Registration: ClinicalTrials.gov NCT05246800; https://clinicaltrials.gov/show/NCT05246800 %M 35302504 %R 10.2196/32123 %U https://mental.jmir.org/2022/3/e32123 %U https://doi.org/10.2196/32123 %U http://www.ncbi.nlm.nih.gov/pubmed/35302504 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e27588 %T Effectiveness, Cost-effectiveness, and Cost-Utility of a Digital Smoking Cessation Intervention for Cancer Survivors: Health Economic Evaluation and Outcomes of a Pragmatic Randomized Controlled Trial %A Mujcic,Ajla %A Blankers,Matthijs %A Boon,Brigitte %A Verdonck-de Leeuw,Irma M %A Smit,Filip %A van Laar,Margriet %A Engels,Rutger %+ Erasmus School of Social and Behavioural Sciences, Erasmus University, Burgemeester Oudlaan 50, Rotterdam, 3062PA, Netherlands, 31 30 29 59 256, amujcic@trimbos.nl %K smoking cessation %K cancer survivors %K effectiveness %K cost-effectiveness %K eHealth %D 2022 %7 17.3.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Smoking cessation (SC) interventions may contribute to better treatment outcomes and the general well-being of cancer survivors. Objective: This study aims to evaluate the effectiveness, cost-effectiveness, and cost-utility of a digital interactive SC intervention compared with a noninteractive web-based information brochure for cancer survivors. Methods: A health economic evaluation alongside a pragmatic 2-arm parallel-group randomized controlled trial was conducted with follow-ups at 3, 6, and 12 months. The study was conducted in the Netherlands over the internet from November 2016 to September 2019. The participants were Dutch adult smoking cancer survivors with the intention to quit smoking. In total, 165 participants were included and analyzed: 83 (50.3%) in the MyCourse group and 82 (49.7%) in the control group. In the intervention group, participants had access to a newly developed, digital, minimally guided SC intervention (MyCourse-Quit Smoking). Control group participants received a noninteractive web-based information brochure on SC. Both groups received unrestricted access to usual care. The primary outcome was self-reported 7-day smoking abstinence at the 6-month follow-up. Secondary outcomes were quality-adjusted life years gained, number of cigarettes smoked, nicotine dependence, and treatment satisfaction. For the health economic evaluation, intervention costs, health care costs, and costs stemming from productivity losses were assessed over a 12-month horizon. Results: At the 6-month follow-up, the quit rates were 28% (23/83) and 26% (21/82) in the MyCourse and control groups, respectively (odds ratio 0.47, 95% CI 0.03-7.86; P=.60). In both groups, nicotine dependence scores were reduced at 12 months, and the number of smoked cigarettes was reduced by approximately half. The number of cigarettes decreased more over time, and the MyCourse group demonstrated a significantly greater reduction at the 12-month follow-up (incidence rate ratio 0.87; 95% CI 0.76-1.00; P=.04). Intervention costs were estimated at US $193 per participant for the MyCourse group and US $74 for the control group. The mean per-participant societal costs were US $25,329 (SD US $29,137) and US $21,836 (SD US $25,792), respectively. In the cost-utility analysis, MyCourse was not preferred over the control group from a societal perspective. With smoking behavior as the outcome, the MyCourse group led to marginally better results per reduced pack-year against higher societal costs, with a mean incremental cost-effectiveness ratio of US $52,067 (95% CI US $32,515-US $81,346). Conclusions: At 6 months, there was no evidence of a differential effect on cessation rates; in both groups, approximately a quarter of the cancer survivors quit smoking and their number of cigarettes smoked was reduced by half. At 12 months, the MyCourse intervention led to a greater reduction in the number of smoked cigarettes, albeit at higher costs than for the control group. No evidence was found for a differential effect on quality-adjusted life years. Trial Registration: The Netherlands Trial Register NTR6011; https://www.trialregister.nl/trial/5434 International Registered Report Identifier (IRRID): RR2-10.1186/s12885-018-4206-z %M 35297777 %R 10.2196/27588 %U https://www.jmir.org/2022/3/e27588 %U https://doi.org/10.2196/27588 %U http://www.ncbi.nlm.nih.gov/pubmed/35297777 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e27760 %T An mHealth Intervention to Reduce the Packing of Discretionary Foods in Children’s Lunch Boxes in Early Childhood Education and Care Services: Cluster Randomized Controlled Trial %A Pearson,Nicole %A Finch,Meghan %A Sutherland,Rachel %A Kingsland,Melanie %A Wolfenden,Luke %A Wedesweiler,Taya %A Herrmann,Vanessa %A Yoong,Sze Lin %+ Hunter New England Population Health, Longworth Avenue, Wallsend, 2308, Australia, 61 02 49246031 ext 46031, Nicole.Pearson@health.nsw.gov.au %K nutrition %K mHealth %K child %K preschool %K parents %D 2022 %7 17.3.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Interventions in early childhood education and care (ECEC) services have the potential to improve children’s diet at the population level. Objective: This study aims to test the efficacy of a mobile health intervention in ECEC services to reduce parent packing of foods high in saturated fat, sugar, and sodium (discretionary foods) in children’s (aged 3-6 years) lunch boxes. Methods: A cluster randomized controlled trial was undertaken with 355 parent and child dyads recruited by phone and in person from 17 ECEC services (8 [47%] intervention and 9 [53%] control services). Parents in the intervention group received a 10-week fully automated program targeting barriers to packing healthy lunch boxes delivered via an existing service communication app. The program included weekly push notifications, within-app messages, and links to further resources, including websites and videos. The control group did not receive any intervention. The primary outcomes were kilojoules from discretionary foods and associated nutrients (saturated fat, free sugars, and sodium) packed in children’s lunch boxes. Secondary outcomes included consumption of kilojoules from discretionary foods and related nutrients and the packing and consumption of serves of discretionary foods and core food groups. Photography and weights of foods in children’s lunch boxes were recorded by trained researchers before and after the trial to assess primary and secondary outcomes. Outcome assessors were blinded to service allocation. Feasibility, appropriateness, and acceptability were assessed via an ECEC service manager survey and a parent web-based survey. Use of the app was assessed via app analytics. Results: Data on packed lunch box contents were collected for 88.8% (355/400) of consenting children at baseline and 84.3% (337/400) of children after the intervention. There was no significant difference between groups in kilojoule from discretionary foods packed (77.84 kJ, 95% CI −163.49 to 319.18; P=.53) or the other primary or secondary outcomes. The per-protocol analysis, including only data from children of parents who downloaded the app, also did not find any statistically significant change in primary (−1.98 kJ, 95% CI −343.87 to 339.90; P=.86) or secondary outcomes. Approximately 61.8% (102/165) of parents in the intervention group downloaded the app, and the mean service viewing rate of weekly within-app messages was 26% (SD 14.9). Parents who responded to the survey and participating services agreed that it was appropriate to receive lunch box information via the app (40/50, 80% and 6/8, 75%, respectively). Conclusions: The intervention was unable to demonstrate an impact on kilojoules or associated nutrients from discretionary foods packed in children’s lunch boxes. Low app downloads and program message views indicate a need to explore how to improve factors related to implementation before further testing similar mobile health interventions in this setting. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618000133235; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374379 %M 35297768 %R 10.2196/27760 %U https://www.jmir.org/2022/3/e27760 %U https://doi.org/10.2196/27760 %U http://www.ncbi.nlm.nih.gov/pubmed/35297768 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 3 %P e25441 %T Usage Intensity of a Relapse Prevention Program and Its Relation to Symptom Severity in Remitted Patients With Anxiety and Depression: Pre-Post Study %A Krijnen-de Bruin,Esther %A Muntingh,Anna DT %A Bourguignon,Evelien M %A Hoogendoorn,Adriaan %A Maarsingh,Otto R %A van Balkom,Anton JLM %A Batelaan,Neeltje M %A van Straten,Annemieke %A van Meijel,Berno %+ Department of Health, Sports and Welfare, Research Group Mental Health Nursing, Inholland University of Applied Sciences, De Boelelaan 1109, Amsterdam, 1081 HV, Netherlands, 31 20 495 1111, esther.krijnendebruin@inholland.nl %K relapse prevention %K anxiety disorder %K depressive disorder %K eHealth %K primary care practice %K usage intensity %K self-management %K mobile phone %D 2022 %7 16.3.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Given that relapse is common in patients in remission from anxiety and depressive disorders, relapse prevention is needed in the maintenance phase. Although existing psychological relapse prevention interventions have proven to be effective, they are not explicitly based on patients’ preferences. Hence, we developed a blended relapse prevention program based on patients’ preferences, which was delivered in primary care practices by mental health professionals (MHPs). This program comprises contact with MHPs, completion of core and optional online modules (including a relapse prevention plan), and keeping a mood and anxiety diary in which patients can monitor their symptoms. Objective: The aims of this study were to provide insight into (1) usage intensity of the program (over time), (2) the course of symptoms during the 9 months of the study, and (3) the association between usage intensity and the course of symptoms. Methods: The Guided E-healTh for RElapse prevention in Anxiety and Depression (GET READY) program was guided by 54 MHPs working in primary care practices. Patients in remission from anxiety and depressive disorders were included. Demographic and clinical characteristics, including anxiety and depressive symptoms, were collected via questionnaires at baseline and after 3, 6, and 9 months. Log data were collected to assess the usage intensity of the program. Results: A total of 113 patients participated in the study. Twenty-seven patients (23.9%) met the criteria for the minimal usage intensity measure. The core modules were used by ≥70% of the patients, while the optional modules were used by <40% of the patients. Usage decreased quickly over time. Anxiety and depressive symptoms remained stable across the total sample; a minority of 15% (12/79) of patients experienced a relapse in their anxiety symptoms, while 10% (8/79) experienced a relapse in their depressive symptoms. Generalized estimating equations analysis indicated a significant association between more frequent face-to-face contact with the MHPs and an increase in both anxiety symptoms (β=.84, 95% CI .39-1.29) and depressive symptoms (β=1.12, 95% CI 0.45-1.79). Diary entries and the number of completed modules were not significantly associated with the course of symptoms. Conclusions: Although the core modules of the GET READY program were used by most of the patients and all patients saw an MHP at least once, usage decreased quickly over time. Most patients remained stable while participating in the study. The significant association between the frequency of contact and the course of symptoms most likely indicates that those who received more support had more symptoms, and thus, it is questionable whether the support offered by the program was sufficient to prevent these patients from relapsing. International Registered Report Identifier (IRRID): RR2-10.1186/s12888-019-2034-6 %M 35293876 %R 10.2196/25441 %U https://mental.jmir.org/2022/3/e25441 %U https://doi.org/10.2196/25441 %U http://www.ncbi.nlm.nih.gov/pubmed/35293876 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 3 %P e30966 %T Effects of a Person-Centered eHealth Intervention for Patients on Sick Leave Due to Common Mental Disorders (PROMISE Study): Open Randomized Controlled Trial %A Cederberg,Matilda %A Alsén,Sara %A Ali,Lilas %A Ekman,Inger %A Glise,Kristina %A Jonsdottir,Ingibjörg H %A Gyllensten,Hanna %A Swedberg,Karl %A Fors,Andreas %+ Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Box 457, Gothenburg, 40530, Sweden, 46 766182014, matilda.cederberg@gu.se %K depression %K anxiety %K stress %K patient-centered care %K person-centered care %K telehealth %K mHealth %K sickness absence %K intervention %K randomized controlled trial %K mobile phone %D 2022 %7 15.3.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Sick leave due to common mental disorders (CMDs) is a public health problem in several countries, including Sweden. Given that symptom relief does not necessarily correspond to return to work, health care interventions focusing on factors that have proven important to influence the return to work process, such as self-efficacy, are warranted. Self-efficacy is also a central concept in person-centered care. Objective: The aim of this study is to evaluate the effects of a person-centered eHealth intervention for patients on sick leave due to CMDs. Methods: A randomized controlled trial of 209 patients allocated to either a control group (107/209, 51.2%) or an intervention group (102/209, 48.8%) was conducted. The control group received usual care, whereas the intervention group received usual care with the addition of a person-centered eHealth intervention. The intervention was built on person-centered care principles and consisted of telephone support and a web-based platform. The primary outcome was a composite score of changes in general self-efficacy (GSE) and level of sick leave at the 6-month follow-up. An intention-to-treat analysis included all participants, and a per-protocol analysis consisted of those using both the telephone support and the web-based platform. Results: At the 3-month follow-up, in the intention-to-treat analysis, more patients in the intervention group improved on the composite score than those in the control group (20/102, 19.6%, vs 10/107, 9.3%; odds ratio [OR] 2.37, 95% CI 1.05-5.34; P=.04). At the 6-month follow-up, the difference was no longer significant between the groups (31/100, 31%, vs 25/107, 23.4%; OR 1.47, 95% CI 0.80-2.73; P=.22). In the per-protocol analysis, a significant difference was observed between the intervention and control groups at the 3-month follow-up (18/85, 21.2%, vs 10/107, 9.3%; OR 2.6, 95% CI 1.13-6.00; P=.02) but not at 6 months (30/84, 35.7%, vs 25/107, 23.4%; OR 1.8, 95% CI 0.97-3.43; P=.06). Changes in GSE drove the effects in the composite score, but the intervention did not affect the level of sick leave. Conclusions: A person-centered eHealth intervention for patients on sick leave due to CMDs improved GSE but did not affect the level of sick leave. Trial Registration: ClinicalTrials.gov NCT03404583; https://clinicaltrials.gov/ct2/show/NCT03404583 %M 35289756 %R 10.2196/30966 %U https://mental.jmir.org/2022/3/e30966 %U https://doi.org/10.2196/30966 %U http://www.ncbi.nlm.nih.gov/pubmed/35289756 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e25821 %T Cost-effectiveness of Web-Based and Home-Based Postnatal Psychoeducational Interventions for First-time Mothers: Economic Evaluation Alongside Randomized Controlled Trial %A Zheng,Qishi %A Shi,Luming %A Zhu,Lixia %A Jiao,Nana %A Chong,Yap Seng %A Chan,Sally Wai-Chi %A Chan,Yiong Huak %A Luo,Nan %A Wang,Wenru %A He,Honggu %+ Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 2, Clinical Research Centre, Block MD11, 10 Medical Drive, Singapore, 117597, Singapore, 65 65167448, nurhhg@nus.edu.sg %K anxiety %K cost-effectiveness %K depression %K first-time mother %K home-based %K postnatal %K psychoeducational %K self-efficacy %K social support %K web-based %D 2022 %7 11.3.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The cost-effectiveness of interventions has attracted increasing interest among researchers. Although web-based and home-based psychoeducational interventions have been developed to improve first-time mothers’ postnatal health outcomes, very limited studies have reported their cost-effectiveness. Objective: The aim of this study was to evaluate the cost-effectiveness of web-based and home-based postnatal psychoeducational interventions for first-time mothers during the early postpartum period. Methods: A randomized controlled 3-group pretest and posttest design was adopted, and cost-effectiveness analysis from the health care’s perspective was conducted. A total of 204 primiparas were recruited from a public tertiary hospital in Singapore from October 2016 to August 2017 who were randomly allocated to the web-based intervention (n=68), home-based intervention (n=68), or control (n=68) groups. Outcomes of maternal parental self-efficacy, social support, postnatal depression, anxiety, and health care resource utilization were measured using valid and reliable instruments at baseline and at 1 month, 3 months, and 6 months after childbirth. The generalized linear regression models on effectiveness and cost were used to assess the incremental cost-effectiveness ratios of the web-based and home-based intervention programs compared to routine care. Projections of cumulative cost over 5 years incurred by the 3 programs at various coverage levels (ie, 10%, 50%, and 100%) were also estimated. Results: The web-based intervention program dominated the other 2 programs (home-based program and routine care) with the least cost (adjusted costs of SGD 376.50, SGD 457.60, and SGD 417.90 for web-based, home-based, and control group, respectively; SGD 1=USD 0.75) and the best improvements in self-efficacy, social support, and psychological well-being. When considering the implementation of study programs over the next 5 years by multiplying the average cost per first-time mother by the estimated average number of first-time mothers in Singapore during the 5-year projection period, the web-based program was the least costly program at all 3 coverage levels. Based on the 100% coverage, the reduced total cost reached nearly SGD 7.1 million and SGD 11.3 million when compared to control and home-based programs at the end of the fifth year, respectively. Conclusions: The web-based approach was promisingly cost-effective to deliver the postnatal psychoeducational intervention to first-time mothers and could be adopted by hospitals as postnatal care support. Trial Registration: ISRCTN registry ISRCTN45202278; https://www.isrctn.com/ISRCTN45202278 %M 35275078 %R 10.2196/25821 %U https://www.jmir.org/2022/3/e25821 %U https://doi.org/10.2196/25821 %U http://www.ncbi.nlm.nih.gov/pubmed/35275078 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 3 %P e31780 %T Telehealth Versus Face-to-face Psychotherapy for Less Common Mental Health Conditions: Systematic Review and Meta-analysis of Randomized Controlled Trials %A Greenwood,Hannah %A Krzyzaniak,Natalia %A Peiris,Ruwani %A Clark,Justin %A Scott,Anna Mae %A Cardona,Magnolia %A Griffith,Rebecca %A Glasziou,Paul %+ Institute for Evidence-Based Healthcare, Bond University, 14 University Drive, Robina, 4226, Australia, 61 755955816 ext 55816, hgreenwo@bond.edu.au %K telemedicine %K psychology %K mental health %K psychotherapy %K primary health care %K behavioral sciences %K systematic review %D 2022 %7 11.3.2022 %9 Review %J JMIR Ment Health %G English %X Background: Mental disorders are a leading cause of distress and disability worldwide. To meet patient demand, there is a need for increased access to high-quality, evidence-based mental health care. Telehealth has become well established in the treatment of illnesses, including mental health conditions. Objective: This study aims to conduct a robust evidence synthesis to assess whether there is evidence of differences between telehealth and face-to-face care for the management of less common mental and physical health conditions requiring psychotherapy. Methods: In this systematic review, we included randomized controlled trials comparing telehealth (telephone, video, or both) versus the face-to-face delivery of psychotherapy for less common mental health conditions and physical health conditions requiring psychotherapy. The psychotherapy delivered had to be comparable between the telehealth and face-to-face groups, and it had to be delivered by general practitioners, primary care nurses, or allied health staff (such as psychologists and counselors). Patient (symptom severity, overall improvement in psychological symptoms, and function), process (working alliance and client satisfaction), and financial (cost) outcomes were included. Results: A total of 12 randomized controlled trials were included, with 931 patients in aggregate; therapies included cognitive behavioral and family therapies delivered in populations encompassing addiction disorders, eating disorders, childhood mental health problems, and chronic conditions. Telehealth was delivered by video in 7 trials, by telephone in 3 trials, and by both in 1 trial, and the delivery mode was unclear in 1 trial. The risk of bias for the 12 trials was low or unclear for most domains, except for the lack of the blinding of participants, owing to the nature of the comparison. There were no significant differences in symptom severity between telehealth and face-to-face therapy immediately after treatment (standardized mean difference [SMD] 0.05, 95% CI −0.17 to 0.27) or at any other follow-up time point. Similarly, there were no significant differences immediately after treatment between telehealth and face-to-face care delivery on any of the other outcomes meta-analyzed, including overall improvement (SMD 0.00, 95% CI −0.40 to 0.39), function (SMD 0.13, 95% CI −0.16 to 0.42), working alliance client (SMD 0.11, 95% CI −0.34 to 0.57), working alliance therapist (SMD −0.16, 95% CI −0.91 to 0.59), and client satisfaction (SMD 0.12, 95% CI −0.30 to 0.53), or at any other time point (3, 6, and 12 months). Conclusions: With regard to effectively treating less common mental health conditions and physical conditions requiring psychological support, there is insufficient evidence of a difference between psychotherapy delivered via telehealth and the same therapy delivered face-to-face. However, there was no includable evidence in this review for some serious mental health conditions, such as schizophrenia and bipolar disorders, and further high-quality research is needed to determine whether telehealth is a viable, equivalent treatment option for these conditions. %M 35275081 %R 10.2196/31780 %U https://mental.jmir.org/2022/3/e31780 %U https://doi.org/10.2196/31780 %U http://www.ncbi.nlm.nih.gov/pubmed/35275081 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 5 %N 1 %P e30795 %T Online-Delivered Over Staff-Delivered Parenting Intervention for Young Children With Disruptive Behavior Problems: Cost-Minimization Analysis %A Ingels,Justin B %A Corso,Phaedra S %A Prinz,Ronald J %A Metzler,Carol W %A Sanders,Matthew R %+ Department of Health Policy and Management, College of Public Health, University of Georgia, 105 Spear Road, Athens, GA, 30602, United States, 1 706 713 2738, ingels@uga.edu %K online parenting intervention %K child disruptive behavior problems %K cost-minimization analysis %K online versus staff delivery %K evidence-based parenting support %K population reach %D 2022 %7 11.3.2022 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: High-prevalence childhood mental health problems like early-onset disruptive behavior problems (DBPs) pose a significant public health challenge and necessitate interventions with adequate population reach. The treatment approach of choice for childhood DBPs, namely evidence-based parenting intervention, has not been sufficiently disseminated when relying solely on staff-delivered services. Online-delivered parenting intervention is a promising strategy, but the cost minimization of this delivery model for reducing child DBPs is unknown compared with the more traditional staff-delivered modality. Objective: This study aimed to examine the cost-minimization of an online parenting intervention for childhood disruptive behavior problems compared with the staff-delivered version of the same content. This objective, pursued in the context of a randomized trial, made use of cost data collected from parents and service providers. Methods: A cost-minimization analysis (CMA) was conducted comparing the online and staff-delivered parenting interventions. Families (N=334) with children 3-7 years old, who exhibited clinically elevated disruptive behavior problems, were randomly assigned to the two parenting interventions. Participants, delivery staff, and administrators provided data for the CMA concerning family participation time and expenses, program delivery time (direct and nondirect), and nonpersonnel resources (eg, space, materials, and access fee). The CMA was conducted using both intent-to-treat and per-protocol analytic approaches. Results: For the intent-to-treat analyses, the online parenting intervention reflected significantly lower program costs (t168=23.2; P<.001), family costs (t185=9.2; P<.001), and total costs (t171=19.1; P<.001) compared to the staff-delivered intervention. The mean incremental cost difference between the interventions was $1164 total costs per case. The same pattern of significant differences was confirmed in the per-protocol analysis based on the families who completed their respective intervention, with a mean incremental cost difference of $1483 per case. All costs were valued or adjusted in 2017 US dollars. Conclusions: The online-delivered parenting intervention in this randomized study produced substantial cost minimization compared with the staff-delivered intervention providing the same content. Cost minimization was driven primarily by personnel time and, to a lesser extent, by facilities costs and family travel time. The CMA was accomplished with three critical conditions in place: (1) the two intervention delivery modalities (ie, online and staff) held intervention content constant; (2) families were randomized to the two parenting interventions; and (3) the online-delivered intervention was previously confirmed to be non-inferior to the staff-delivered intervention in significantly reducing the primary outcome, child disruptive behavior problems. Given those conditions, cost minimization for the online parenting intervention was unequivocal. Trial Registration: ClinicalTrials.gov NCT02121431; https://clinicaltrials.gov/ct2/show/NCT02121431 %M 35275084 %R 10.2196/30795 %U https://pediatrics.jmir.org/2022/1/e30795 %U https://doi.org/10.2196/30795 %U http://www.ncbi.nlm.nih.gov/pubmed/35275084 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e27791 %T Implementation of Cognitive Behavioral Therapy in e–Mental Health Apps: Literature Review %A Denecke,Kerstin %A Schmid,Nicole %A Nüssli,Stephan %+ Institute for Medical Informatics, Bern University of Applied Sciences, Quellgasse 21, Biel, 2501, Switzerland, 41 32 321 67 94, kerstin.denecke@bfh.ch %K cognitive behavioral therapy %K mHealth %K e–mental health %K chatbot %K mobile phone %D 2022 %7 10.3.2022 %9 Review %J J Med Internet Res %G English %X Background: To address the matter of limited resources for treating individuals with mental disorders, e–mental health has gained interest in recent years. More specifically, mobile health (mHealth) apps have been suggested as electronic mental health interventions accompanied by cognitive behavioral therapy (CBT). Objective: This study aims to identify the therapeutic aspects of CBT that have been implemented in existing mHealth apps and the technologies used. From these, we aim to derive research gaps that should be addressed in the future. Methods: Three databases were screened for studies on mHealth apps in the context of mental disorders that implement techniques of CBT: PubMed, IEEE Xplore, and ACM Digital Library. The studies were independently selected by 2 reviewers, who then extracted data from the included studies. Data on CBT techniques and their technical implementation in mHealth apps were synthesized narratively. Results: Of the 530 retrieved citations, 34 (6.4%) studies were included in this review. mHealth apps for CBT exploit two groups of technologies: technologies that implement CBT techniques for cognitive restructuring, behavioral activation, and problem solving (exposure is not yet realized in mHealth apps) and technologies that aim to increase user experience, adherence, and engagement. The synergy of these technologies enables patients to self-manage and self-monitor their mental state and access relevant information on their mental illness, which helps them cope with mental health problems and allows self-treatment. Conclusions: There are CBT techniques that can be implemented in mHealth apps. Additional research is needed on the efficacy of the mHealth interventions and their side effects, including inequalities because of the digital divide, addictive internet behavior, lack of trust in mHealth, anonymity issues, risks and biases for user groups and social contexts, and ethical implications. Further research is also required to integrate and test psychological theories to improve the impact of mHealth and adherence to the e–mental health interventions. %M 35266875 %R 10.2196/27791 %U https://www.jmir.org/2022/3/e27791 %U https://doi.org/10.2196/27791 %U http://www.ncbi.nlm.nih.gov/pubmed/35266875 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 9 %N 1 %P e28875 %T Comparison of the Impact of Conventional and Web-Based Pulmonary Rehabilitation on Physical Activity in Patients With Chronic Obstructive Pulmonary Disease: Exploratory Feasibility Study %A Chaplin,Emma %A Barnes,Amy %A Newby,Chris %A Houchen-Wolloff,Linzy %A Singh,Sally J %+ Centre for Exercise and Rehabilitation Science, National Institute for Health Research Leicester Biomedical Research Centre- Respiratory, University Hospitals of Leicester National Health Service Trust, Groby Road, Leicester, LE3 9QP, United Kingdom, 44 116 258 3181, emma.chaplin@uhl-tr.nhs.uk %K SPACE for COPD %K internet %K web-based %K chronic obstructive pulmonary disease %K pulmonary rehabilitation %K physical activity %K exercise %K chronic disease %K COPD %K rehabilitation %D 2022 %7 10.3.2022 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: Pulmonary Rehabilitation (PR) increases exercise capacity, with less clear evidence regarding physical activity (PA). The World Health Organization recommends at least 150-300 minutes of moderate-intensity or 75-150 minutes of vigorous-intensity aerobic PA per week to reduce the risks of chronic disease. Objective: The objective of this study was to assess the effectiveness of conventional PR versus web-based PR with respect to changes in PA. Methods: Patients with COPD were randomized to either conventional PR classes (n=51) or a web-based PR program (n=52) for 7 weeks in a feasibility study. Accelerometers (Sensewear) were worn before and after the intervention, and PA was measured as steps per day and mean bouts of moderate activity for ≥2, ≥5, ≥10, and ≥20 minutes. Measures were derived for patients with ≥8 hours of data per day for ≥4 days, using the R package for statistical analysis. Variables were explored to examine their relationships with bouts of activity. Results: Baseline characteristics did not differ significantly between groups. Complete PA data were available for the groups receiving web-based (n=20) and conventional (n=34) PR interventions. The web-based PR group demonstrated a nonsignificant increase in the number of steps per day, which mainly comprised short bouts of moderate to vigorous intensity PA when compared to the conventional PR group (P=.20). The conventional PR group demonstrated increased 20-minute bouts of PA by 49.1%, although this was not significant (P=.07). At baseline, age (r=–0.21, P=.04), BMI (r=–0.311, P=.004), and FEV1 (forced expiratory volume in 1 second; % predicted; r=–0.248, P=.048) were significantly correlated with 10-minute bouts of PA; however, this was not observed post intervention. Conclusions: The analysis revealed a nonsignificant difference in the pattern of PA between groups receiving conventional vs web-based PR—the former being associated with an increase in 20-minute bouts, while the latter having demonstrated an increase in the number of steps per day. There appears to be a differing response emerging between the two interventions. Trial Registration: International Clinical Trials Registry ISRCTN03142263; https://tinyurl.com/y4dmfyrb %M 35266871 %R 10.2196/28875 %U https://rehab.jmir.org/2022/1/e28875 %U https://doi.org/10.2196/28875 %U http://www.ncbi.nlm.nih.gov/pubmed/35266871 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e33883 %T The Effect of the Imacoco Care Psychoeducation Website on Improving Psychological Distress Among Workers During the COVID-19 Pandemic: Randomized Controlled Trial %A Imamura,Kotaro %A Sasaki,Natsu %A Sekiya,Yuki %A Watanabe,Kazuhiro %A Sakuraya,Asuka %A Matsuyama,Yutaka %A Nishi,Daisuke %A Kawakami,Norito %+ Department of Mental Health, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan, 81 3 5841 3522, nkawakami@m.u-tokyo.ac.jp %K COVID-19 %K education %K internet-based intervention %K occupational groups %K psychological distress %K mental health %K digital health %K health intervention %K psychoeducation %D 2022 %7 10.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The prolonged COVID-19 pandemic has affected mental health among workers. Psychoeducational intervention via a website could be effective for primary prevention of mental illness among workers in the current COVID-19 pandemic. Objective: The aim of this randomized controlled trial is to examine the effect of a newly developed online psychoeducational website named Imacoco Care on reducing psychological distress and fear about COVID-19 infection among workers. Methods: Participants in the study were recruited from registered members of a web survey company in Japan. Participants who fulfilled the eligibility criteria were randomly allocated to the intervention or control group. Participants in the intervention group were invited to access the Imacoco Care program within a month after the baseline survey. The Kessler Psychological Distress Scale (K6) and the Fear of COVID-19 Scale (FCV-19S) scores were obtained at baseline and at 1- and 3-month follow-ups. Results: A total of 1200 workers were randomly allocated to the intervention and control groups (n=600 [50%] per group). The Imacoco Care intervention group showed a significant favorable effect on K6 scores (P=.03) with a small effect size (ES; Cohen d=–0.14) and an adverse effect on FCV-19S scores (P=.01) with a small ES (Cohen d=0.16) at 3-month follow-up. In the per protocol analysis (including only participants who had read the Imacoco Care content at least 1 time), the Imacoco Care intervention group also showed a significant favorable effect on reducing K6 scores (P=.03), while an adverse effect on FCV-19S scores was not significant (P=.06) in the intervention group at 3-month follow-up. Conclusions: A web-based psychoeducation approach may be effective for improving psychological distress among workers; however, it may be important not only to distribute information but also to encourage active engagement with the content of the program to prevent adverse effects of psychoeducational intervention. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000042556; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048548 %M 35133972 %R 10.2196/33883 %U https://formative.jmir.org/2022/3/e33883 %U https://doi.org/10.2196/33883 %U http://www.ncbi.nlm.nih.gov/pubmed/35133972 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e34088 %T System-Level Factors Associated With Telephone and Video Visit Use: Survey of Safety-Net Clinicians During the Early Phase of the COVID-19 Pandemic %A Sharma,Anjana E %A Khoong,Elaine C %A Sierra,Maribel %A Rivadeneira,Natalie A %A Nijagal,Malini A %A Su,George %A Lyles,Courtney R %A DeFries,Triveni %A Tuot,Delphine S %A Sarkar,Urmimala %+ Department of Family & Community Medicine, University of California San Francisco, 995 Potrero Ave, Ward 83, San Francisco, CA, 94110, United States, 1 4155708619, anjana.sharma@ucsf.edu %K telemedicine %K safety-net hospitals %K health care delivery %K ambulatory care %K vulnerable populations %K COVID-19 %K survey %K vulnerable %K telehealth %K hospital %K safety %K delivery %K video %K implementation %K health system %D 2022 %7 10.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The COVID-19 pandemic prompted safety-net health care systems to rapidly implement telemedicine services with little prior experience, causing disparities in access to virtual visits. While much attention has been given to patient barriers, less is known regarding system-level factors influencing telephone versus video-visit adoption. As telemedicine remains a preferred service for patients and providers, and reimbursement parity will not continue for audio visits, health systems must evaluate how to support higher-quality video visit access. Objective: This study aimed to assess health system–level factors and their impact on telephone and video visit adoption to inform sustainability of telemedicine for ambulatory safety-net sites. Methods: We conducted a cross-sectional survey among ambulatory care clinicians at a hospital-linked ambulatory clinic network serving a diverse, publicly insured patient population between May 28 and July 14, 2020. We conducted bivariate analyses assessing health care system–level factors associated with (1) high telephone adoption (4 or more visits on average per session); and (2) video visit adoption (at least 1 video visit on average per session). Results: We collected 311 responses from 643 eligible clinicians, yielding a response rate of 48.4%. Clinician respondents (N=311) included 34.7% (n=108) primary or urgent care, 35.1% (n=109) medical, and 7.4% (n=23) surgical specialties. Our sample included 178 (57.2%) high telephone adopters and 81 (26.05%) video adopters. Among high telephone adopters, 72.2% utilized personal devices for telemedicine (vs 59.0% of low telephone adopters, P=.04). Video nonadopters requested more training in technical aspects than adopters (49.6% vs 27.2%, P<.001). Primary or urgent care had the highest proportion of high telephone adoption (84.3%, compared to 50.4% of medical and 37.5% of surgical specialties, P<.001). Medical specialties had the highest proportion of video adoption (39.1%, compared to 14.8% of primary care and 12.5% of surgical specialties, P<.001). Conclusions: Personal device access and department specialty were major factors associated with high telephone and video visit adoption among safety-net clinicians. Desire for training was associated with lower video visit use. Secure device access, clinician technical trainings, and department-wide assessments are priorities for safety-net systems implementing telemedicine. %M 35148271 %R 10.2196/34088 %U https://formative.jmir.org/2022/3/e34088 %U https://doi.org/10.2196/34088 %U http://www.ncbi.nlm.nih.gov/pubmed/35148271 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e27202 %T An mHealth Intervention to Improve Medication Adherence and Health Outcomes Among Patients With Coronary Heart Disease: Randomized Controlled Trial %A Ni,Zhao %A Wu,Bei %A Yang,Qing %A Yan,Lijing L %A Liu,Changqing %A Shaw,Ryan J %+ School of Medicine, Yale University, 135 College Street, New Haven, CT, 06510, United States, 1 646 617 2232, zhao.ni@yale.edu %K mHealth %K medication adherence %K coronary disease %K blood pressure %K China %K randomized controlled trial %D 2022 %7 9.3.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The treatment of many chronic illnesses involves long-term pharmaceutical therapy, but it is an ongoing challenge to find effective ways to improve medication adherence to promote good health outcomes. Cardioprotective medications can prevent the enlargement of harmful clots, cardiovascular symptoms, and poor therapeutic outcomes, such as uncontrolled high blood pressure and hyperlipidemia, for patients with coronary heart disease. Poor adherence to cardioprotective medications, however, has been reported as a global health concern among patients with coronary heart disease, and it is particularly a concern in China. Objective: This study aimed to evaluate the efficacy of a mobile health (mHealth) intervention using 2 mobile apps to improve medication adherence and health outcomes. Methods: A randomized, placebo-controlled, 2-arm parallel study was conducted in a major university-affiliated medical center located in Chengdu, China. Participants were recruited by flyers and health care provider referrals. Each participant was observed for 90 days, including a 60-day period of mHealth intervention and a 30-day period of nonintervention follow-up. The study coordinator used WeChat and Message Express to send educational materials and reminders to take medication, respectively. Participants used WeChat to receive both the educational materials and reminders. Participants in the control group only received educational materials. This study received ethics approval from the Duke Health Institutional Review Board (Pro00073395) on May 5, 2018, and was approved by West China Hospital (20170331180037). Recruitment began on May 20, 2018. The pilot phase of this study was registered on June 8, 2016, and the current, larger-scale study was retrospectively registered on January 11, 2021 (ClinicalTrials.gov). Results: We recruited 230 patients with coronary heart disease. Of these patients, 196 completed the baseline survey and received the intervention. The majority of participants were married (181/196, 92.4%), male (157/196, 80.1%), and lived in urban China (161/196, 82.1%). Participants’ average age was 61 years, and half were retired (103/191, 53.9%). More than half the participants (121/196, 61.7%) were prescribed at least 5 medications. The mean decrease in medication nonadherence score was statistically significant at both 60 days (t179=2.04, P=.04) and 90 days (t155=3.48, P<.001). Systolic blood pressure and diastolic blood pressure decreased in the experimental group but increased in the control group. The mean decrease in diastolic blood pressure was statistically significant at both 60 days (t160=2.07, P=.04) and 90 days (t164=2.21, P=.03). The mean decrease in systolic blood pressure was significantly different in the groups at 90 days (t165=3.12, P=.002). Conclusions: The proposed mHealth intervention can improve medication adherence and health outcomes, including systolic blood pressure and diastolic blood pressure. Trial Registration: ClinicalTrials.gov NCT02793830; https://clinicaltrials.gov/ct2/show/NCT02793830 and ClinicalTrials.gov NCT04703439; https://clinicaltrials.gov/ct2/show/NCT04703439 %M 35262490 %R 10.2196/27202 %U https://www.jmir.org/2022/3/e27202 %U https://doi.org/10.2196/27202 %U http://www.ncbi.nlm.nih.gov/pubmed/35262490 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e26374 %T Weight Loss Trajectories in Healthy Weight Coaching: Cohort Study %A Kupila,Sakris K E %A Venäläinen,Mikko S %A Suojanen,Laura-Unnukka %A Rosengård-Bärlund,Milla %A Ahola,Aila J %A Elo,Laura L %A Pietiläinen,Kirsi H %+ Obesity Research Unit, Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, P.O. Box 63, University of Helsinki, Helsinki, FI-00014, Finland, 358 02941911, sakris.kupila@helsinki.fi %K acceptance and commitment therapy %K body weight %K eHealth %K obesity management %K real-life intervention %K web-based %K mobile phone %D 2022 %7 9.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: As global obesity prevalence continues to increase, there is a need for accessible and affordable weight management interventions, such as web-based programs. Objective: This paper aims to assess the outcomes of healthy weight coaching (HWC), a web-based obesity management program integrated into standard Finnish clinical care. Methods: HWC is an ongoing, structured digital 12-month program based on acceptance and commitment therapy. It includes weekly training sessions focused on lifestyle, general health, and psychological factors. Participants received remote one-on-one support from a personal coach. In this real-life, single-arm, prospective cohort study, we examined the total weight loss, weight loss profiles, and variables associated with weight loss success and program retention in 1189 adults (963 women) with a BMI >25 kg/m² among participants of the program between October 2016 and March 2019. Absolute (kg) and relative (%) weight loss from the baseline were the primary outcomes. We also examined the weight loss profiles, clustered based on the dynamic time-warping distance, and the possible variables associated with greater weight loss success and program retention. We compared different groups using the Mann-Whitney test or Kruskal-Wallis test for continuous variables and the chi-squared test for categorical variables. We analyzed changes in medication using the McNemar test. Results: Among those having reached the 12-month time point (n=173), the mean weight loss was 4.6% (SE 0.5%), with 43% (n=75) achieving clinically relevant weight loss (≥5%). Baseline BMI ≥40 kg/m² was associated with a greater weight loss than a lower BMI (mean 6.6%, SE 0.9%, vs mean 3.2%, SE 0.6%; P=.02). In addition, more frequent weight reporting was associated with greater weight loss. No significant differences in weight loss were observed according to sex, age, baseline disease, or medication use. The total dropout rate was 29.1%. Dropouts were slightly younger than continuers (47.2, SE 0.6 years vs 49.2, SE 0.4 years; P=.01) and reported their weight less frequently (3.0, SE 0.1 entries per month vs 3.3, SE 0.1 entries per month; P<.001). Conclusions: A comprehensive web-based program such as HWC is a potential addition to the repertoire of obesity management in a clinical setting. Heavier patients lost more weight, but weight loss success was otherwise independent of baseline characteristics. %M 35262494 %R 10.2196/26374 %U https://formative.jmir.org/2022/3/e26374 %U https://doi.org/10.2196/26374 %U http://www.ncbi.nlm.nih.gov/pubmed/35262494 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e29663 %T The Effectiveness of Mobile Phone Messaging–Based Interventions to Promote Physical Activity in Type 2 Diabetes Mellitus: Systematic Review and Meta-analysis %A Alsahli,Mohammed %A Abd-Alrazaq,Alaa %A Househ,Mowafa %A Konstantinidis,Stathis %A Blake,Holly %+ Division of Information and Computing Technology, College of Science and Engineering, Hamad Bin Khalifa University, Qatar Foundation, PO Box 34110, Doha Al Luqta St, Ar-Rayyan, Doha, 11023/2093, Qatar, 974 55708549, mhouseh@hbku.edu.qa %K type 2 diabetes mellitus %K physical activity %K mobile phone messaging %K systematic review %K meta-analysis %D 2022 %7 8.3.2022 %9 Review %J J Med Internet Res %G English %X Background: The prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide. Physical activity (PA) is an important aspect of self-care and first line management for T2DM. SMS text messaging can be used to support self-management in people with T2DM, but the effectiveness of mobile text message–based interventions in increasing PA is still unclear. Objective: This study aims to assess the effectiveness of mobile phone messaging on PA in people with T2DM by summarizing and pooling the findings of previous literature. Methods: A systematic review was conducted to accomplish this objective. Search sources included 5 bibliographic databases (MEDLINE, Cochrane Library, CINAHL, Web of Science, and Embase), the search engine Google Scholar (Google Inc), and backward and forward reference list checking of the included studies and relevant reviews. A total of 2 reviewers (MA and AA) independently carried out the study selection, data extraction, risk of bias assessment, and quality of evidence evaluation. The results of the included studies were synthesized narratively and statistically, as appropriate. Results: We included 3.8% (6/151) of the retrieved studies. The results of individual studies were contradictory regarding the effectiveness of mobile text messaging on PA. However, a meta-analysis of the results of 5 studies showed no statistically significant effect (P=.16) of text messages on PA in comparison with no intervention. A meta-analysis of the findings of 2 studies showed a nonsignificant effect (P=.14) of text messages on glycemic control. Of the 541 studies, 2 (0.4%) found a nonsignificant effect of text messages on anthropometric measures (weight and BMI). Conclusions: We could not draw a definitive conclusion regarding the effectiveness of text messaging on PA, glycemic control, weight, or BMI among patients with T2MD, given the limited number of included studies and their high risk of bias. Therefore, there is a need for more high-quality primary studies. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020156465; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=156465 %M 35258463 %R 10.2196/29663 %U https://www.jmir.org/2022/3/e29663 %U https://doi.org/10.2196/29663 %U http://www.ncbi.nlm.nih.gov/pubmed/35258463 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 5 %N 1 %P e30364 %T The Development of an mHealth Tool for Children With Long-term Illness to Enable Person-Centered Communication: User-Centered Design Approach %A Wiljén,Angelica %A Chaplin,John Eric %A Crine,Vanessa %A Jobe,William %A Johnson,Ensa %A Karlsson,Katarina %A Lindroth,Tomas %A Schwarz,Anneli %A Stenmarker,Margaretha %A Thunberg,Gunilla %A Öhlén,Joakim %A Nilsson,Stefan %+ Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Box 457, Gothenburg, 405 30, Sweden, 46 738538951, stefan.nilsson.4@gu.se %K children %K communication %K long-term illness %K mHealth %K pediatric care %K person-centered care %K symptom assessment %K universal design %D 2022 %7 8.3.2022 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Children with long-term illnesses frequently experience symptoms that could negatively affect their daily lives. These symptoms are often underreported in health care. Despite a large number of mobile health (mHealth) tools, few are based on a theoretical framework or supported by scientific knowledge. Incorporating universal design when developing a product can promote accessibility and facilitate person-centered communication. Objective: The aim of this study is to identify the symptom-reporting needs of children with cancer and congenital heart defects that could be satisfied by using a mobile app. Another aim is to evaluate how the child might interact with the app by considering universal design principles and to identify parents’ views and health care professionals’ expectations and requirements for an mHealth tool. Methods: User-centered design is an iterative process that focuses on an understanding of the users. The adapted user-centered design process includes 2 phases with 4 stages. Phase 1 involved interviews with 7 children with long-term illnesses, 8 parents, and 19 health care professionals to determine their needs and wishes for support; a workshop with 19 researchers to deepen our understanding of the needs; and a workshop with developers to establish a preliminary tool to further investigate needs and behaviors. Phase 2 involved interviews with 10 children with long-term illnesses, 9 parents, and 21 health care professionals to evaluate the mock-up (prototype) of the mHealth tool. Data were synthesized using the interpretive description technique. Results: A total of 4 aspects of needs emerged from the synthesis of the data, as follows: different perspectives on provided and perceived support; the need for an easy-to-use, non–clinic-based tool to self-report symptoms and to facilitate communication; the need for safety by being in control and reaching the child’s voice; and a way of mapping the illness journey to facilitate recall and improve diagnostics. The children with long-term illnesses expressed a need to not only communicate about pain but also communicate about anxiety, fatigue, fear, and nausea. Conclusions: The findings of this study indicated that the PicPecc (Pictorial Support in Person-Centered Care for Children) app is a potential solution for providing communicative support to children with long-term illnesses dealing with multiple symptoms and conditions. The interview data also highlighted symptoms that are at risk of being overlooked if they are not included in the mobile app. Further studies are needed to include usability testing and evaluation in hospitals and home care settings. %M 35258466 %R 10.2196/30364 %U https://pediatrics.jmir.org/2022/1/e30364 %U https://doi.org/10.2196/30364 %U http://www.ncbi.nlm.nih.gov/pubmed/35258466 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e32669 %T A Tailored App for the Self-management of Musculoskeletal Conditions: Evidencing a Logic Model of Behavior Change %A Berry,Alice %A McClellan,Carey %A Wanless,Ben %A Walsh,Nicola %+ University of the West of England, Glenside Campus, Blackberry Hill, Bristol, BS16 1DD, United Kingdom, 44 117 32 87802, alice.berry@uwe.ac.uk %K musculoskeletal %K supported self-management %K behavior change %K digital health intervention %K behavior change wheel %D 2022 %7 8.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Musculoskeletal conditions such as joint pain are a growing problem, affecting 18.8 million people in the United Kingdom. Digital health interventions (DHIs) are a potentially effective way of delivering information and supporting self-management. It is vital that the development of such interventions is transparent and can illustrate how individual components work, how they link back to the theoretical constructs they are attempting to change, and how this might influence outcomes. getUBetter is a DHI developed to address the lack of personalized, supported self-management tools available to patients with musculoskeletal conditions by providing knowledge, skills, and confidence to navigate through a self-management journey. Objective: The aim of this study was to map a logic model of behavior change for getUBetter to illustrate how the content and functionality of the DHI are aligned with recognized behavioral theory, effective behavior change techniques, and clinical guidelines. Methods: A range of behavior change models and frameworks were used, including the behavior change wheel and persuasive systems design framework, to map the logic model of behavior change underpinning getUBetter. The three main stages included understanding the behavior the intervention is attempting to change, identifying which elements of the intervention might bring about the desired change in behavior, and describing intervention content and how this can be optimally implemented. Results: The content was mapped to 25 behavior change techniques, including information about health consequences, instruction on how to perform a behavior, reducing negative emotions, and verbal persuasion about capability. Mapping to the persuasive system design framework illustrated the use of a number of persuasive design principles, including tailoring, personalization, simulation, and reminders. Conclusions: This process enabled the proposed mechanisms of action and theoretical foundations of getUBetter to be comprehensively described, highlighting the key techniques used to support patients to self-manage their condition. These findings provide guidance for the ongoing evaluation of the effectiveness (including quality of engagement) of the intervention and highlight areas that might be strengthened in future iterations. %M 35258462 %R 10.2196/32669 %U https://formative.jmir.org/2022/3/e32669 %U https://doi.org/10.2196/32669 %U http://www.ncbi.nlm.nih.gov/pubmed/35258462 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 1 %P e31376 %T Mobile Health to Support Community-Integration of Individuals With Disabilities Using iMHere 2.0: Focus Group Study %A Ward,Rebecca E %A Setiawan,I Made Agus %A Quinby,Eleanor %A Fair,Melva %A Ambadar,Zara %A Parmanto,Bambang %A Dicianno,Brad E %+ Human Engineering Research Laboratories, Veterans Affairs Pittsburgh Healthcare System, VA Pittsburgh Healthcare System, 6425 Penn AVE, Suite 400, Pittsburgh, PA, 15206-4022, United States, 1 412 822 3700, dicianno@pitt.edu %K community integration %K self-care %K mobile health %K smartphone %K rehabilitation %K disability %K mobile phone %D 2022 %7 4.3.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Mobile health (mHealth) systems that support self-management can improve medical, functional, and psychosocial outcomes for individuals with disabilities and chronic conditions. The mHealth systems can potentially be expanded to support community integration. Objective: The purposes of this study were to (1) partner with a community-based organization that supports community integration of individuals with disabilities; (2) identify software requirements needed to support community participation; and (3) iteratively refine an existing mHealth application to include new requirements. Methods: Community Living and Support Services (CLASS), a nonprofit organization that serves individuals with disabilities in Pittsburgh, Pennsylvania, was identified as the focus group for this study. Key stakeholders within the Community Partners Program at CLASS proposed design requirements for an existing mHealth application, Interactive Mobile Health and Rehabilitation (iMHere) 2.0, that has been used to support self-management. Results: We gathered qualitative data from a focus group composed of CLASS members to develop and iteratively revise iMHere 2.0 to include new modules and features to support community integration. A caregiver app was also developed. The new system contains features to support finance, transportation, client and caregiver communication, calendar and checklist management, upcoming medical and nonmedical appointments, social engagement, pain management, and access to a personal profile. Modifications were made to the following existing modules: education, mood, personal health record, goals, medications, and nutrition. Conclusions: A successful partnership with a community-based organization that supports individuals with disabilities resulted in a newly designed mHealth system with features to support community integration. %M 35254274 %R 10.2196/31376 %U https://humanfactors.jmir.org/2022/1/e31376 %U https://doi.org/10.2196/31376 %U http://www.ncbi.nlm.nih.gov/pubmed/35254274 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e33701 %T Digital Life Coaching During Stem Cell Transplantation: Development and Usability Study %A Banerjee,Rahul %A Huang,Chiung-Yu %A Dunn,Lisa %A Knoche,Jennifer %A Ryan,Chloe %A Brassil,Kelly %A Jackson,Lindsey %A Patel,Dhiren %A Lo,Mimi %A Arora,Shagun %A Wong,Sandy W %A Wolf,Jeffrey %A Martin III,Thomas %A Dhruva,Anand %A Shah,Nina %+ Division of Hematology/Oncology, Department of Medicine, University of California San Francisco, 400 Parnassus Avenue, San Francisco, CA, 94158, United States, 1 415 353 8000, rahul.banerjee.md@gmail.com %K digital health %K life coaching %K multiple myeloma %K stem cell transplantation %K stem cell therapy %K cancer %K high-dose chemotherapy %K patient engagement %K feasibility %K digital life coaching %K mobile phone %D 2022 %7 4.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: For patients with multiple myeloma receiving high-dose chemotherapy followed by autologous stem cell transplantation (SCT), acute life disruptions and symptom burden may lead to worsened quality of life (QOL) and increased emotional distress. Digital life coaching (DLC), whereby trained coaches deliver personalized well-being–related support via phone calls and SMS text messaging, has been shown to improve QOL among SCT survivors. However, DLC has not been investigated during the acute peri-SCT period, which is generally characterized by symptomatic exacerbations and 2-week hospitalizations. Objective: We launched a single-arm pilot study to investigate the feasibility of patient engagement with DLC during this intensive period. Methods: We approached English-speaking adult patients with multiple myeloma undergoing autologous SCT at our center. Enrolled patients received 16 weeks of virtual access to a life coach beginning on day −5 before SCT. Coaches used structured frameworks to help patients identify and overcome personal barriers to well-being. Patients chose the coaching topics and preferred communication styles. Our primary endpoint was ongoing DLC engagement, defined as bidirectional conversations occurring at least once every 4 weeks during the study period. Secondary endpoints were electronic patient-reported outcome assessments of QOL, distress, and sleep disturbances. Results: Of the 20 patients who were screened, 17 (85%) chose to enroll and 15 (75%) underwent SCT as planned. Of these 15 patients (median age 65 years, range 50-81 years), 11 (73%) demonstrated ongoing DLC engagement. The median frequency of bidirectional conversations during the 3-month study period was once every 6.2 days (range 3.9-28 days). During index hospitalizations with median lengths of stay of 16 days (range 14-31 days), the median frequency of conversations was once every 5.3 days (range 2.7-15 days). Electronic patient-reported outcome assessments (94% adherence) demonstrated an expected QOL nadir during the second week after SCT. The prevalence of elevated distress was highest immediately before and after SCT, with 69% of patients exhibiting elevated distress on day −5 and on day +2. Conclusions: DLC may be feasible for older patients during intensive hospital-based cancer treatments such as autologous SCT for multiple myeloma. The limitations of our study include small sample size, selection bias among enrolled patients, and heterogeneity in DLC use. Based on the positive results of this pilot study, a larger phase 2 randomized study of DLC during SCT is underway to investigate the efficacy of DLC with regard to patient well-being. Trial Registration: ClinicalTrials.gov NCT04432818; https://clinicaltrials.gov/ct2/show/NCT04432818. %M 35039279 %R 10.2196/33701 %U https://formative.jmir.org/2022/3/e33701 %U https://doi.org/10.2196/33701 %U http://www.ncbi.nlm.nih.gov/pubmed/35039279 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 1 %P e31317 %T Developing an Educational Website for Women With Endometriosis-Associated Dyspareunia: Usability and Stigma Analysis %A Abdulai,Abdul-Fatawu %A Howard,A Fuchsia %A Yong,Paul J %A Noga,Heather %A Parmar,Gurkiran %A Currie,Leanne M %+ The School of Nursing, University of British Columbia, T201-2211 Wesbrook Mall, Vancouver, BC, V6T 2B5, Canada, 1 7782230137, Fatawu@student.ubc.ca %K endometriosis %K sexual pain %K dyspareunia %K usability testing %K think-aloud %K stigma %K web sites %K digital health %K informatics %D 2022 %7 3.3.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Endometriosis is a chronic condition that affects approximately 10% of women worldwide. Despite its wide prevalence, knowledge of endometriosis symptoms, such as pelvic pain, and treatments remains relatively low. This not only leads to a trivialization of symptoms and delayed diagnosis but also fuels myths and misconceptions about pain symptoms. At the same time, the use of web-based platforms for information seeking is particularly common among people with conditions that are perceived as stigmatizing and difficult to discuss. The Sex, Pain, and Endometriosis website is an educational resource designed to provide evidence-based information on endometriosis and sexual pain to help people understand the condition, feel empowered, dispel myths, and destigmatize endometriosis-associated sexual pain. Objective: The study objective is to evaluate the usability of the website and assess for destigmatizing properties of sexual health–related web-based resources. Methods: We conducted a usability analysis by using a think-aloud observation, a postsystem usability questionnaire, and follow-up interviews with 12 women with endometriosis. The think-aloud data were analyzed using the framework by Kushniruk and Patel for analyzing usability video data, the questionnaire data were analyzed using descriptive statistics, and the follow-up interviews were analyzed using simple content analysis. We conducted a usability assessment by deductively analyzing the interview data via a trauma-informed care framework and a content analysis approach. Results: Through usability analysis, we found the website to be simple, uncluttered, satisfying, and easy to use. However, 30 minor usability problems related to navigation; website response; the comprehension of graphics, icons, and tabs; the understanding of content; and mismatch between the website and users’ expectations were reported. In our stigma analysis, we found the web content to be nonstigmatizing. The participants suggested ways in which websites could be designed to address stigma, including ensuring privacy, anonymity, inclusiveness, and factual and nonjudgmental content, as well as providing opportunities for web-based engagement. Conclusions: Overall, the participants found the website to be useful, easy to use, and satisfying. The usability problems identified were largely minor and informed the website redesign process. In the context of the limited literature on stigma and website design, this paper offers useful strategies on how sexual health–related websites can be designed to be acceptable and less stigmatizing to individuals with sensitive health issues. %M 35238789 %R 10.2196/31317 %U https://humanfactors.jmir.org/2022/1/e31317 %U https://doi.org/10.2196/31317 %U http://www.ncbi.nlm.nih.gov/pubmed/35238789 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 3 %P e35332 %T Evaluation of Digital Interventions for Physical Activity Promotion: Protocol for a Scoping Review %A De Santis,Karina Karolina %A Jahnel,Tina %A Mergenthal,Lea %A Zeeb,Hajo %A Matthias,Katja %+ Department of Prevention and Evaluation, Leibniz Institute for Prevention Research and Epidemiology – BIPS, Achterstraße 30, Bremen, 28359, Germany, 49 421 218 56 908, desantis@leibniz-bips.de %K evaluation %K digital intervention %K physical activity promotion %K scoping review %K digital health %D 2022 %7 3.3.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Digital interventions (DIs) could support physical activity (PA) promotion, according to recent reviews. However, it remains unclear if and how DIs for PA promotion are evaluated; thus, it is unclear if they support behavior change in real-world settings. A mapping of evidence from published reviews is required to focus on the evaluation of DIs for PA promotion. Objective: The aim of our study is to investigate evaluation strategies for any outcome in the context of DIs for PA promotion by conducting a scoping review of published reviews. Methods: Our scoping review adheres to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. The information sources include bibliographic databases (MEDLINE, PsycINFO, and CINAHL) and the bibliographies of the selected studies. The electronic search strategy was developed and conducted in collaboration with an experienced database specialist. The electronic search was conducted in English with no limits up to March 19, 2021, for sources with the terms digital intervention AND evaluation AND physical activity in titles or abstracts. After deduplication, 300 reviews selected from 4912 search results were assessed for eligibility by 2 authors working independently. The inclusion criteria were (1) healthy or clinical samples (population), (2) DIs for PA promotion (intervention), (3) comparisons to any other intervention or no intervention (comparison), (4) evaluation strategies (methods, results, or frameworks) for any outcome in the context of DIs for PA promotion (outcome), and (5) any published review (study type). According to the consensus reached during a discussion, 40 reviews met the inclusion criteria—36 from the electronic search and 4 from the manual search of the bibliographies of the 36 reviews. All reviews reported the evaluation strategies for any outcomes in the context of DIs for PA promotion in healthy or clinical samples. Data coding and the quality appraisal of systematic reviews are currently being performed independently by 2 authors. Results: Our scoping review includes data from 40 published reviews (1 rapid review, 9 scoping reviews, and 30 systematic reviews). The focus of data coding is on evaluation strategies in the context of DIs for PA promotion and on the critical appraisal of the included systematic reviews. The final consensus regarding all data is expected in early 2022. Conclusions: Interventions for PA promotion that are supported by digital technologies require evaluation to ensure their efficacy in real-world settings. Our scoping review is needed because it addresses novel objectives that focus on such evaluations and are not answered in the published reviews identified in our search. The evaluation strategies addressing DIs for PA promotion will be mapped to synthesize the results that have been reported in published reviews so far. International Registered Report Identifier (IRRID): DERR1-10.2196/35332 %M 35238321 %R 10.2196/35332 %U https://www.researchprotocols.org/2022/3/e35332 %U https://doi.org/10.2196/35332 %U http://www.ncbi.nlm.nih.gov/pubmed/35238321 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 1 %P e28697 %T Supporting Management of Noncommunicable Diseases With Mobile Health (mHealth) Apps: Experimental Study %A Kela,Neta %A Eytam,Eleanor %A Katz,Adi %+ Shamoon College of Engineering, 84 Jabotinsky St, Ashdod, 77245, Israel, 972 088519309, neta.kela@gmail.com %K mHealth %K digital health %K instrumentality %K aesthetics %K symbolic value %K preference %D 2022 %7 2.3.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Noncommunicable diseases (NCDs) are the leading global health problem in this century and are the principal causes of death and health care spending worldwide. Mobile health (mHealth) apps can help manage and prevent NCDs if people are willing to use them as supportive tools. Still, many people are reluctant to adopt these technologies. Implementing new apps could result in earlier intervention for many health conditions, preventing more serious complications. Objective: This research project aimed to test the factors that facilitate the adoption of mHealth apps by users with NCDs. We focused on determining, first, what user interface (UI) qualities and complexity levels appeal to users in evaluating mHealth apps. We also wanted to determine whether people prefer that the data collected by an mHealth app be analyzed using a physician or an artificial intelligence (AI) algorithm. The contribution of this work is both theoretical and practical. We examined users’ considerations when adopting mHealth apps that promote healthy lifestyles and helped them manage their NCDs. Our results can also help direct mHealth app UI designers to focus on the most appealing aspects of our findings. Methods: A total of 347 respondents volunteered to rate 3 models of mHealth apps based on 16 items that measured instrumentality, aesthetics, and symbolism. Respondents rated each model after reading 1 of 2 different scenarios. In one scenario, a physician analyzed the data, whereas, in the other, the data were analyzed by an AI algorithm. These scenarios tested the degree of trust people placed in AI algorithms versus the “human touch” of a human physician regarding analyzing data collected by an mHealth app. Results: As shown by the responses, the involvement of a human physician in the application had a significant effect (P<.001) on the perceived instrumentality of the simple model. The complex model with more controls was rated significantly more aesthetic when associated with a physician performing data analysis rather than an AI algorithm (P=.03). Conclusions: Generally, when participants found a human touch in the mHealth app (connection to a human physician who they assumed would analyze their data), they judged the app more favorably. Simple models were evaluated more positively than complex ones, and aesthetics and symbolism were salient predictors of preference. These trends suggest that designers and developers of mHealth apps should keep the designs simple and pay special attention to aesthetics and symbolic value. %M 35234653 %R 10.2196/28697 %U https://humanfactors.jmir.org/2022/1/e28697 %U https://doi.org/10.2196/28697 %U http://www.ncbi.nlm.nih.gov/pubmed/35234653 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e26525 %T Supporting Behavior Change in Sedentary Adults via Real-time Multidimensional Physical Activity Feedback: Mixed Methods Randomized Controlled Trial %A Western,Max James %A Standage,Martyn %A Peacock,Oliver James %A Nightingale,Tom %A Thompson,Dylan %+ Department for Health, University of Bath, Claverton Down, Bath, BA2 7AY, United Kingdom, 44 1225 383732, M.J.Western@bath.ac.uk %K physical activity %K feedback %K wearables %K behavior change %K sedentary time %D 2022 %7 2.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Increasing physical activity (PA) behavior remains a public health priority, and wearable technology is increasingly being used to support behavior change efforts. Using wearables to capture and provide comprehensive, visually persuasive, multidimensional feedback with real-time support may be a promising way of increasing PA in inactive individuals. Objective: This study aims to explore whether a 6-week self-monitoring intervention using composite web-based multidimensional PA feedback with real-time daily feedback supports increased PA in adults. Methods: A 6-week, mixed methods, 2-armed exploratory randomized controlled trial with 6-week follow-up was used, whereby low to moderately active (PA level [PAL] <2.0) adults (mean age 51.3 years, SD 8.4 years; women 28/51, 55%) were randomly assigned to receive the self-monitoring intervention (36/51, 71%) or waiting list control (15/51, 29%). Assessment of PA across multiple health-harnessing PA dimensions (eg, PAL, weekly moderate to vigorous intensity PA, sedentary time, and steps), psychosocial cognitions (eg, behavioral regulation, barrier self-efficacy, and habit strength), and health were made at the prerandomization baseline at 6 and 12 weeks. An exploratory analysis of the mean difference and CIs was conducted using the analysis of covariance model. After the 12-week assessment, intervention participants were interviewed to explore their views on the program. Results: There were no notable differences in any PA outcome immediately after the intervention; however, at 12 weeks, moderate-to-large effects were observed with a mean difference in PAL of 0.09 (95% CI 0.02-0.15; effect size [Hedges g] 0.8), daily moderate-intensity PA of 24 (95% CI 0-45; Hedges g=0.6) minutes, weekly moderate-to-vigorous intensity PA of 195 (95% CI 58-331; Hedges g=0.8) minutes, and steps of 1545 (95% CI 581-2553; Hedges g=0.7). Descriptive analyses suggested that the differences in PA at 12 weeks were more pronounced in women and participants with lower baseline PA levels. Immediately after the intervention, there were favorable differences in autonomous motivation, controlled motivation, perceived competence for PA, and barrier self-efficacy, with the latter sustained at follow-up. Qualitative data implied that the intervention was highly informative for participants and that the real-time feedback element was particularly useful in providing tangible, day-to-day behavioral support. Conclusions: Using wearable trackers to capture and present sophisticated multidimensional PA feedback combined with discrete real-time support may be a useful way of facilitating changes in behavior. Further investigation into the ways of optimizing the use of wearables in inactive participants and testing the efficacy of this approach via a robust study design is warranted. Trial Registration: ClinicalTrials.gov NCT02432924; https://clinicaltrials.gov/ct2/show/NCT02432924 %M 35234658 %R 10.2196/26525 %U https://formative.jmir.org/2022/3/e26525 %U https://doi.org/10.2196/26525 %U http://www.ncbi.nlm.nih.gov/pubmed/35234658 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e32130 %T Increasing the Effectiveness of a Physical Activity Smartphone Intervention With Positive Suggestions: Randomized Controlled Trial %A Skvortsova,Aleksandrina %A Cohen Rodrigues,Talia %A de Buisonjé,David %A Kowatsch,Tobias %A Santhanam,Prabhakaran %A Veldhuijzen,Dieuwke S %A van Middendorp,Henriët %A Evers,Andrea %+ Department of Psychology, McGill University, 1205 avenue du Docteur-Penfield, Montreal, QC, H3A 1B1, Canada, 1 4386303664, a.skvortsova@fsw.leidenuniv.nl %K eHealth %K mobile health %K physical activity %K walking %K positive suggestions %K outcome expectations %K mobile phone %D 2022 %7 1.3.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: eHealth interventions have the potential to increase the physical activity of users. However, their effectiveness varies, and they often have only short-term effects. A possible way of enhancing their effectiveness is to increase the positive outcome expectations of users by giving them positive suggestions regarding the effectiveness of the intervention. It has been shown that when individuals have positive expectations regarding various types of interventions, they tend to benefit from these interventions more. Objective: The main objective of this web-based study is to investigate whether positive suggestions can change the expectations of participants regarding the effectiveness of a smartphone physical activity intervention and subsequently enhance the number of steps the participants take during the intervention. In addition, we study whether suggestions affect perceived app effectiveness, engagement with the app, self-reported vitality, and fatigue of the participants. Methods: This study involved a 21-day fully automated physical activity intervention aimed at helping participants to walk more steps. The intervention was delivered via a smartphone-based app that delivered specific tasks to participants (eg, setting activity goals or looking for social support) and recorded their daily step count. Participants were randomized to either a positive suggestions group (69/133, 51.9%) or a control group (64/133, 48.1%). Positive suggestions emphasizing the effectiveness of the intervention were implemented in a web-based flyer sent to the participants before the intervention. Suggestions were repeated on days 8 and 15 of the intervention via the app. Results: Participants significantly increased their daily step count from baseline compared with 21 days of the intervention (t107=−8.62; P<.001) regardless of the suggestions. Participants in the positive suggestions group had more positive expectations regarding the app (B=−1.61, SE 0.47; P<.001) and higher expected engagement with the app (B=3.80, SE 0.63; P<.001) than the participants in the control group. No effects of suggestions on the step count (B=−22.05, SE 334.90; P=.95), perceived effectiveness of the app (B=0.78, SE 0.69; P=.26), engagement with the app (B=0.78, SE 0.75; P=.29), and vitality (B=0.01, SE 0.11; P=.95) were found. Positive suggestions decreased the fatigue of the participants during the 3 weeks of the intervention (B=0.11, SE 0.02; P<.001). Conclusions: Although the suggestions did not affect the number of daily steps, they increased the positive expectations of the participants and decreased their fatigue. These results indicate that adding positive suggestions to eHealth physical activity interventions might be a promising way of influencing subjective but not objective outcomes of interventions. Future research should focus on finding ways of strengthening the suggestions, as they have the potential to boost the effectiveness of eHealth interventions. Trial Registration: Open Science Framework 10.17605/OSF.IO/CWJES; https://osf.io/cwjes %M 35230245 %R 10.2196/32130 %U https://www.jmir.org/2022/3/e32130 %U https://doi.org/10.2196/32130 %U http://www.ncbi.nlm.nih.gov/pubmed/35230245 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 3 %P e35234 %T The Behavior Change Techniques Used in Canadian Online Smoking Cessation Programs: Content Analysis %A Struik,Laura %A Rodberg,Danielle %A Sharma,Ramona H %+ School of Nursing, University of British Columbia, 1147 Research Road, Kelowna, BC, V1V 1V7, Canada, 1 2508078000, laura.struik@ubc.ca %K content analysis %K smoking cessation %K internet %K behavior change technique %K mental health %K smoking %K online program %K website %K government %K federal %K provincial %D 2022 %7 1.3.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Smoking rates in Canada remain unacceptably high, and cessation rates have stalled in recent years. Online cessation programs, touted for their ability to reach many different populations anytime, have shown promise in their efficacy. The Government of Canada has therefore funded provincial and national smoking cessation websites countrywide. However, little is known about the behavior change techniques (BCTs) that underpin the content of these websites, which is key to establishing the quality of the websites, as well as a way forward for evaluation. Objective: The purpose of this study, therefore, is to apply the BCTTv1 taxonomy to Canadian provincial and federal websites, and to determine which BCTs they use. Methods: A total of 12 government-funded websites across Canada were included for analysis. Using deductive content analysis and through training in applying the BCTTv1 taxonomy, the website content was coded according to the 93 BCTs across the 16 BCT categories. Results: Of the 16 BCT categories, 14 were present within the websites. The most widely represented BCT categories (used in all 12 websites) included goals and planning, social support, natural consequences, and regulation. Implementation of BCTs within these categories varied across the sites. Conclusions: Analyzing the content of online smoking cessation websites using the BCTTv1 taxonomy is an appropriate method for identifying the behavior change content of these programs. The findings offer programmers and researchers tangible directions for prioritizing and enhancing provincial and national smoking cessation programs, and an evaluation framework to assess smoking cessation outcomes in relation to the web-based content. %M 35230253 %R 10.2196/35234 %U https://mental.jmir.org/2022/3/e35234 %U https://doi.org/10.2196/35234 %U http://www.ncbi.nlm.nih.gov/pubmed/35230253 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 2 %P e26479 %T A Web-Based Cognitive Behavioral Therapy, Mindfulness Meditation, and Yoga Intervention for Posttraumatic Stress Disorder: Single-Arm Experimental Clinical Trial %A Kirk,Megan A %A Taha,Bilal %A Dang,Kevin %A McCague,Hugh %A Hatzinakos,Dimitrios %A Katz,Joel %A Ritvo,Paul %+ Yale Center for Emotional Intelligence, Yale School of Medicine, Yale University, 350 George Street, 3rd Floor, New Haven, CT, 06511, United States, 1 203 432 4326 ext 24326, megan.kirkchang@yale.edu %K posttraumatic stress disorder %K cognitive therapy %K internet delivery %K pupillometry %K psychophysiology %K PTSD %K therapy %K cognitive behavioral therapy %K mindfulness %K intervention %D 2022 %7 28.2.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Posttraumatic stress disorder (PTSD) is a debilitating, undertreated condition. The web-based delivery of cognitive behavioral therapy supplemented with mindfulness meditation and yoga is a viable treatment that emphasizes self-directed daily practice. Objective: This study aims to examine the effectiveness of a web-based cognitive behavioral therapy, mindfulness, and yoga (CBT-MY) program designed for daily use. Methods: We conducted an 8-week, single-arm, experimental, registered clinical trial on adults reporting PTSD symptoms (n=22; aged 18-35 years). Each participant received web-based CBT-MY content and an hour of web-based counseling each week. Pre-post outcomes included self-reported PTSD symptom severity, depression, anxiety, chronic pain, and mindfulness. Pre-post psychophysiological outcomes included peak pupil dilation (PPD) and heart rate variability (HRV). HRV and PPD were also compared with cross-sectional data from a non-PTSD comparison group without a history of clinical mental health diagnoses and CBT-MY exposure (n=46). Results: Pre-post intention-to-treat analyses revealed substantial improvements in PTSD severity (d=1.60), depression (d=0.83), anxiety (d=0.99), and mindfulness (d=0.88). Linear multilevel mixed models demonstrated a significant pre-post reduction in PPD (B=−0.06; SE=0.01; P<.001; d=0.90) but no significant pre-post change in HRV (P=.87). Overall, participants spent an average of 11.53 (SD 22.76) min/day on self-directed mindfulness practice. Conclusions: Web-based CBT-MY was associated with clinically significant symptom reductions and significant PPD changes, suggesting healthier autonomic functioning. Future randomized controlled trials are needed to further examine the gains apparent in this single-arm study. Trial Registration: ClinicalTrials.gov NCT03684473; https://clinicaltrials.gov/ct2/show/NCT03684473 %M 34499613 %R 10.2196/26479 %U https://mental.jmir.org/2022/2/e26479 %U https://doi.org/10.2196/26479 %U http://www.ncbi.nlm.nih.gov/pubmed/34499613 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 5 %N 1 %P e29623 %T Older Adults’ and Clinicians’ Perspectives on a Smart Health Platform for the Aging Population: Design and Evaluation Study %A Cristiano,Alessia %A Musteata,Stela %A De Silvestri,Sara %A Bellandi,Valerio %A Ceravolo,Paolo %A Cesari,Matteo %A Azzolino,Domenico %A Sanna,Alberto %A Trojaniello,Diana %+ Center for Advanced Technology in Health and Wellbeing, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Milan, Italy, 39 0226432919, trojaniello.diana@hsr.it %K smart health %K remote monitoring %K requirement elicitation %K older population %K age-related chronic conditions %K healthy aging %K Internet of Things %K mobile phone %D 2022 %7 28.2.2022 %9 Original Paper %J JMIR Aging %G English %X Background: Over recent years, interest in the development of smart health technologies aimed at supporting independent living for older populations has increased. The integration of innovative technologies, such as the Internet of Things, wearable technologies, artificial intelligence, and ambient-assisted living applications, represents a valuable solution for this scope. Designing such an integrated system requires addressing several aspects (eg, equipment selection, data management, analytics, costs, and users’ needs) and involving different areas of expertise (eg, medical science, service design, biomedical and computer engineering). Objective: The objective of this study is 2-fold; we aimed to design the functionalities of a smart health platform addressing 5 chronic conditions prevalent in the older population (ie, hearing loss, cardiovascular diseases, cognitive impairments, mental health problems, and balance disorders) by considering both older adults’ and clinicians’ perspectives and to evaluate the identified smart health platform functionalities with a small group of older adults. Methods: Overall, 24 older adults (aged >65 years) and 118 clinicians were interviewed through focus group activities and web-based questionnaires to elicit the smart health platform requirements. Considering the elicited requirements, the main functionalities of smart health platform were designed. Then, a focus group involving 6 older adults was conducted to evaluate the proposed solution in terms of usefulness, credibility, desirability, and learnability. Results: Eight main functionalities were identified and assessed—cognitive training and hearing training (usefulness: 6/6, 100%; credibility: 6/6, 100%; desirability: 6/6, 100%; learnability: 6/6, 100%), monitoring of physiological parameters (usefulness: 6/6, 100%; credibility: 6/6, 100%; desirability: 6/6, 100%; learnability: 5/6, 83%), physical training (usefulness: 6/6, 100%; credibility: 6/6, 100%; desirability: 5/6, 83%; learnability: 2/6, 33%), psychoeducational intervention (usefulness: 6/6, 100%; credibility: 6/6, 100%; desirability: 4/6, 67%; learnability: 2/6, 33%), mood monitoring (usefulness: 4/6, 67%; credibility: 4/6, 67%; desirability: 3/6, 50%; learnability: 5/6, 50%), diet plan (usefulness: 5/6, 83%; credibility: 4/6, 67%; desirability: 1/6, 17%; learnability: 2/6, 33%), and environment monitoring and adjustment (usefulness: 1/6, 17%; credibility: 1/6, 17%; desirability: 0/6, 0%; learnability: 0/6, 0%). Most of them were highly appreciated by older participants, with the only exception being environment monitoring and adjustment. The results showed that the proposed functionalities met the needs and expectations of users (eg, improved self-management of patients’ disease and enhanced patient safety). However, some aspects need to be addressed (eg, technical and privacy issues). Conclusions: The presented smart health platform functionalities seem to be able to meet older adults’ needs and desires to enhance their self-awareness and self-management of their medical condition, encourage healthy and independent living, and provide evidence-based support for clinicians’ decision-making. Further research with a larger and more heterogeneous pool of stakeholders in terms of demographics and clinical conditions is needed to assess system acceptability and overall user experience in free-living conditions. %M 35225818 %R 10.2196/29623 %U https://aging.jmir.org/2022/1/e29623 %U https://doi.org/10.2196/29623 %U http://www.ncbi.nlm.nih.gov/pubmed/35225818 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e31675 %T The 3-Month Effectiveness of a Stratified Blended Physiotherapy Intervention in Patients With Nonspecific Low Back Pain: Cluster Randomized Controlled Trial %A Koppenaal,Tjarco %A Pisters,Martijn F %A Kloek,Corelien JJ %A Arensman,Remco M %A Ostelo,Raymond WJG %A Veenhof,Cindy %+ Research Group Empowering Healthy Behaviour, Department of Health Innovations and Technology, Fontys University of Applied Sciences, Postbus 347, 5600 AH, Eindhoven, Netherlands, 31 653945086, t.koppenaal@fontys.nl %K eHealth %K nonspecific low back pain %K physiotherapy %K blended care %K mobile phone %D 2022 %7 25.2.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Patient education, home-based exercise therapy, and advice on returning to normal activities are established physiotherapeutic treatment options for patients with nonspecific low back pain (LBP). However, the effectiveness of physiotherapy interventions on health-related outcomes largely depends on patient self-management and adherence to exercise and physical activity recommendations. e-Exercise LBP is a recently developed stratified blended care intervention comprising a smartphone app integrated with face-to-face physiotherapy treatment. Following the promising effects of web-based applications on patients’ self-management skills and adherence to exercise and physical activity recommendations, it is hypothesized that e-Exercise LBP will improve patients’ physical functioning. Objective: This study aims to investigate the short-term (3 months) effectiveness of stratified blended physiotherapy (e-Exercise LBP) on physical functioning in comparison with face-to-face physiotherapy in patients with nonspecific LBP. Methods: The study design was a multicenter cluster randomized controlled trial with intention-to-treat analysis. Patients with nonspecific LBP aged ≥18 years were asked to participate in the study. The patients were treated with either stratified blended physiotherapy or face-to-face physiotherapy. Both interventions were conducted according to the Dutch physiotherapy guidelines for nonspecific LBP. Blended physiotherapy was stratified according to the patients’ risk of developing persistent LBP using the Keele STarT Back Screening Tool. The primary outcome was physical functioning (Oswestry Disability Index, range 0-100). Secondary outcomes included pain intensity, fear-avoidance beliefs, and self-reported adherence. Measurements were taken at baseline and at the 3-month follow-up. Results: Both the stratified blended physiotherapy group (104/208, 50%) and the face-to-face physiotherapy group (104/208, 50%) had improved clinically relevant and statistically significant physical functioning; however, there was no statistically significant or clinically relevant between-group difference (mean difference −1.96, 95% CI −4.47 to 0.55). For the secondary outcomes, stratified blended physiotherapy showed statistically significant between-group differences in fear-avoidance beliefs and self-reported adherence. In patients with a high risk of developing persistent LBP (13/208, 6.3%), stratified blended physiotherapy showed statistically significant between-group differences in physical functioning (mean difference −16.39, 95% CI −27.98 to −4.79) and several secondary outcomes. Conclusions: The stratified blended physiotherapy intervention e-Exercise LBP is not more effective than face-to-face physiotherapy in patients with nonspecific LBP in improving physical functioning in the short term. For both stratified blended physiotherapy and face-to-face physiotherapy, within-group improvements were clinically relevant. To be able to decide whether e-Exercise LBP should be implemented in daily physiotherapy practice, future research should focus on the long-term cost-effectiveness and determine which patients benefit most from stratified blended physiotherapy. Trial Registration: ISRCTN Registry 94074203; https://doi.org/10.1186/ISRCTN94074203 International Registered Report Identifier (IRRID): RR2-10.1186/s12891-020-3174-z %M 35212635 %R 10.2196/31675 %U https://www.jmir.org/2022/2/e31675 %U https://doi.org/10.2196/31675 %U http://www.ncbi.nlm.nih.gov/pubmed/35212635 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 2 %P e35776 %T A Brief, Daily, Online Mental Health and Well-being Intervention for University Staff During the COVID-19 Pandemic: Program Description and Outcomes Using a Mixed Methods Design %A Parker,Alexandra %A Dash,Sarah %A Bourke,Matthew %A Patten,Rhiannon %A Craike,Melinda %A Baldwin,Peter %A Hosking,Warwick %A Levinger,Itamar %A Apostolopoulos,Vasso %A de Courten,Maximilian %A Sharples,Jenny %A Naslund,Monika %A Stavropoulos,Vasileios %A Woessner,Mary %A Sonn,Christopher %A Stansen,Caroline %A Pascoe,Michaela %+ Institute for Health and Sport, Victoria University, Ballarat Road, Melbourne, 3011, Australia, 61 399195874, alex.parker@vu.edu.au %K workplace mental health %K well-being %K mental health promotion %K online intervention %K telehealth %K COVID-19 pandemic %K COVID-19 %K pandemic %K health promotion %D 2022 %7 25.2.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The unprecedented changes and isolation measures to contain COVID-19 have had multiple psychological and social impacts, with implications for professional and personal functioning. Evidence-informed interventions that can be rapidly implemented under pandemic conditions to support mental health during such times are urgently needed. Objective: The aim of this study was to determine the acceptability and preliminary outcomes of a daily online mental health promotion program for tertiary education staff during the COVID-19 pandemic. Methods: The “Victoria University (VU) Elevenses” program was delivered as an uncontrolled intervention at Victoria University (VU) in the western metropolitan region of Melbourne, Australia. In April 2020, an email invitation was sent to all academic and professional staff inviting them to: (1) participate in the program and (2) opt-in to the research component. The “VU Elevenses” program provided 10-15–minute microinterventions comprising lifestyle and well-being strategies to promote mental health via an online meeting platform at 11 AM each weekday. A mixed methods approach was used to evaluate the program, combining structured questionnaires with semistructured interviews to investigate the experiences of staff who participated in the program. Results: Between 16 and 90 participants provided weekly program feedback. A total of 106 university staff opted into the longitudinal research component and 10 staff participated in the interviews. Participants reported high levels of satisfaction with sessions and perceived benefits for mental health. Approximately one quarter of participants reported moderate to severe symptoms of depression, anxiety, and stress at baseline, with significant reductions in these symptoms in the first 7 weeks of the program, corresponding with easing in mandatory isolation (“lockdown”) restrictions. Symptoms of depression, anxiety, and stress all increased when lockdown measures were reintroduced, but not to the same levels as found during the initial lockdown period. Overall changes in depression and anxiety from baseline to the end of the program were explained by changes in COVID-19–related distress, whereas changes in self-compassion explained changes in stress. Conclusions: We show that it is feasible and acceptable to develop and deliver a program of brief interventions in a timely manner, using a simple and accessible online platform. Although participation in the program was initially associated with reduced symptoms of depression, anxiety, and stress, participants’ mental health worsened with the reintroduction of a “lockdown” period. However, as symptoms of depression, anxiety, and stress did not return to levels observed at the start of the VU Elevenses program, participation in the uncontrolled intervention may have offered a protective benefit against the impact of the second significant lockdown period. %M 35044304 %R 10.2196/35776 %U https://formative.jmir.org/2022/2/e35776 %U https://doi.org/10.2196/35776 %U http://www.ncbi.nlm.nih.gov/pubmed/35044304 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 2 %P e33451 %T Evaluation of an Experimental Web-based Educational Module on Opioid-related Occupational Safety Among Police Officers: Protocol for a Randomized Pragmatic Trial to Minimize Barriers to Overdose Response %A Simmons,Janie %A Elliott,Luther %A Bennett,Alex S %A Beletsky,Leo %A Rajan,Sonali %A Anders,Brad %A Dastparvardeh,Nicole %+ Department of Social and Behavioral Sciences, School of Global Public Health, New York University, 708 Broadway, 4th floor, Rm. 459, New York, NY, 10003, United States, 1 2129923807, js8822@nyu.edu %K occupational health %K law enforcement %K police/education %K naloxone %K opioid overdose prevention and response training %K online education %K opioids %K occupational risk %D 2022 %7 25.2.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: As drug-related morbidity and mortality continue to surge, police officers are on the front lines of the North American overdose (OD) crisis. Drug law enforcement shapes health risks among people who use drugs (PWUD), while also impacting the occupational health and wellness of officers. Effective interventions to align law enforcement practices with public health and occupational safety goals remain underresearched. Objective: The Opioids and Police Safety Study (OPS) aims to shift police practices relating to PWUD. It adapts and evaluates the relative effectiveness of a curriculum that bundles content on public health promotion with occupational risk reduction (ORR) to supplement a web-based OD response and naloxone training platform (GetNaloxoneNow.org, or GNN). This novel approach has the potential to improve public health and occupational safety practices, including using naloxone to reverse ODs, referring PWUD to treatment and other supportive services, and avoiding syringe confiscation. Methods: This longitudinal study uses a randomized pragmatic trial design. A sample of 300 active-duty police officers from select counties in Pennsylvania, Vermont, and New Hampshire with high OD fatality rates will be randomized (n=150 each) to either the experimental arm (GNN + OPS) or the control arm (GNN + COVID-19 ORR). A pre- and posttraining survey will be administered to all 300 officers, after which they will be administered quarterly surveys for 12 months. A subsample of police officers will also be qualitatively followed in a simultaneous embedded mixed-methods approach. Research ethics approval was obtained from the New York University Institutional Review Board. Results: Results will provide an understanding of the experiences, knowledge, and perceptions of this sample of law enforcement personnel. Generalized linear models will be used to analyze differences in key behavioral outcomes between the participants in each of the 2 study arms and across multiple time points (anticipated minimum effect size to be detected, d=0.50). Findings will be disseminated widely, and the training products will be available nationally once the study is completed. Conclusions: The OPS is the first study to longitudinally assess the impact of a web-based opioid-related ORR intervention for law enforcement in the U.S. Our randomized pragmatic clinical trial aims to remove barriers to life-saving police engagement with PWUD/people who inject drugs by focusing both on the safety of law enforcement and evidence-based and best practices for working with persons at risk of an opioid OD. Our simultaneous embedded mixed-methods approach will provide empirical evaluation of the diffusion of the naloxone-based response among law enforcement. Trial Registration: ClinicalTrail.gov NCT05008523; https://clinicaltrials.gov/show/NCT05008523 International Registered Report Identifier (IRRID): DERR1-10.2196/33451 %M 35212639 %R 10.2196/33451 %U https://www.researchprotocols.org/2022/2/e33451 %U https://doi.org/10.2196/33451 %U http://www.ncbi.nlm.nih.gov/pubmed/35212639 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e31530 %T Digitally Supported Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Secondary Analysis of Long-Term User Engagement Trajectories in a Randomized Controlled Trial %A Lavikainen,Piia %A Mattila,Elina %A Absetz,Pilvikki %A Harjumaa,Marja %A Lindström,Jaana %A Järvelä-Reijonen,Elina %A Aittola,Kirsikka %A Männikkö,Reija %A Tilles-Tirkkonen,Tanja %A Lintu,Niina %A Lakka,Timo %A van Gils,Mark %A Pihlajamäki,Jussi %A Martikainen,Janne %+ School of Pharmacy, University of Eastern Finland, P.O. Box 1627, Kuopio, 70211, Finland, 358 407024682, piia.lavikainen@uef.fi %K type 2 diabetes %K user engagement %K digital behavior change intervention %K trajectories %K habit formation %K mobile health %D 2022 %7 24.2.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital health interventions may offer a scalable way to prevent type 2 diabetes (T2D) with minimal burden on health care systems by providing early support for healthy behaviors among adults at increased risk for T2D. However, ensuring continued engagement with digital solutions is a challenge impacting the expected effectiveness. Objective: We aimed to investigate the longitudinal usage patterns of a digital healthy habit formation intervention, BitHabit, and the associations with changes in T2D risk factors. Methods: This is a secondary analysis of the StopDia (Stop Diabetes) study, an unblinded parallel 1-year randomized controlled trial evaluating the effectiveness of the BitHabit app alone or together with face-to-face group coaching in comparison with routine care in Finland in 2017-2019 among community-dwelling adults (aged 18 to 74 years) at an increased risk of T2D. We used longitudinal data on usage from 1926 participants randomized to the digital intervention arms. Latent class growth models were applied to identify user engagement trajectories with the app during the study. Predictors for trajectory membership were examined with multinomial logistic regression models. Analysis of covariance was used to investigate the association between trajectories and 12-month changes in T2D risk factors. Results: More than half (1022/1926, 53.1%) of the participants continued to use the app throughout the 12-month intervention. The following 4 user engagement trajectories were identified: terminated usage (904/1926, 46.9%), weekly usage (731/1926, 38.0%), twice weekly usage (208/1926, 10.8%), and daily usage (83/1926, 4.3%). Active app use during the first month, higher net promoter score after the first 1 to 2 months of use, older age, and better quality of diet at baseline increased the odds of belonging to the continued usage trajectories. Compared with other trajectories, daily usage was associated with a higher increase in diet quality and a more pronounced decrease in BMI and waist circumference at 12 months. Conclusions: Distinct long-term usage trajectories of the BitHabit app were identified, and individual predictors for belonging to different trajectory groups were found. These findings highlight the need for being able to identify individuals likely to disengage from interventions early on, and could be used to inform the development of future adaptive interventions. Trial Registration: ClinicalTrials.gov NCT03156478; https://clinicaltrials.gov/ct2/show/NCT03156478 International Registered Report Identifier (IRRID): RR2-10.1186/s12889-019-6574-y %M 35200147 %R 10.2196/31530 %U https://www.jmir.org/2022/2/e31530 %U https://doi.org/10.2196/31530 %U http://www.ncbi.nlm.nih.gov/pubmed/35200147 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e33062 %T Digital Health Technologies to Improve Medication Adherence and Treatment Outcomes in Patients With Tuberculosis: Systematic Review of Randomized Controlled Trials %A Ridho,Abdurahman %A Alfian,Sofa D %A van Boven,Job F M %A Levita,Jutti %A Yalcin,Esin Aki %A Le,Ly %A Alffenaar,Jan-Willem %A Hak,Eelko %A Abdulah,Rizky %A Pradipta,Ivan S %+ Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Jl. Raya Bandung-Sumedang Km. 21, Jatinangor, Sumedang, 45363, Indonesia, 62 842 888888 ext 3510, ivanpradipta@unpad.ac.id %K tuberculosis %K intervention %K eHealth %K medication adherence technology %K nonadherence %K digital health %K systematic review %K treatment outcomes %D 2022 %7 23.2.2022 %9 Review %J J Med Internet Res %G English %X Background: Nonadherence to medication in tuberculosis (TB) hampers optimal treatment outcomes. Digital health technology (DHT) seems to be a promising approach to managing problems of nonadherence to medication and improving treatment outcomes. Objective: This paper systematically reviews the effect of DHT in improving medication adherence and treatment outcomes in patients with TB. Methods: A literature search in PubMed and Cochrane databases was conducted. Randomized controlled trials (RCTs) that analyzed the effect of DHT interventions on medication adherence outcomes (treatment completion, treatment adherence, missed doses, and noncompleted rate) and treatment outcomes (cure rate and smear conversion) were included. Adult patients with either active or latent TB infection were included. The Jadad score was used for evaluating the study quality. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guideline was followed to report study findings. Results: In all, 16 RCTs were selected from 552 studies found, and 6 types of DHT interventions for TB were identified: 3 RCTs examined video directly observed therapy (VDOT), 1 examined video-observed therapy (VOT), 1 examined an ingestible sensor, 1 examined phone call reminders, 2 examined medication monitor boxes, and 8 examined SMS text message reminders. The outcomes used were treatment adherence, including treatment completion, treatment adherence, missed dose, and noncompleted rate, as well as clinical outcomes, including cure rate and smear conversion. In treatment completion, 4 RCTs (VDOT, VOT, ingestible sensor, SMS reminder) found significant effects, with odds ratios and relative risks (RRs) ranging from 1.10 to 7.69. Treatment adherence was increased in 1 study by SMS reminders (RR 1.05; 95% CI 1.04-1.06), and missed dose was reduced in 1 study by a medication monitor box (mean ratio 0.58; 95% CI 0.42-0.79). In contrast, 3 RCTs of VDOT and 3 RCTs of SMS reminders did not find significant effects for treatment completion. Moreover, no improvement was found in treatment adherence in 1 RCT of VDOT, missed dose in 1 RCT of SMS reminder, and noncompleted rate in 1 RCT of a monitor box, and 2 RCTs of SMS reminders. For clinical outcomes such as cure rate, 2 RCTs reported that phone calls (RR 1.30; 95% CI 1.07-1.59) and SMS reminders (OR 2.47; 95% CI 1.13-5.43) significantly affected cure rates. However, 3 RCTs found that SMS reminders did not have a significant impact on cure rate or smear conversion. Conclusions: It was found that DHT interventions can be a promising approach. However, the interventions exhibited variable effects regarding effect direction and the extent of improving TB medication adherence and clinical outcomes. Developing DHT interventions with personalized feedback is required to have a consistent and beneficial effect on medication adherence and outcomes among patients with TB. %M 35195534 %R 10.2196/33062 %U https://www.jmir.org/2022/2/e33062 %U https://doi.org/10.2196/33062 %U http://www.ncbi.nlm.nih.gov/pubmed/35195534 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e33337 %T Digitalized Cognitive Behavioral Interventions for Depressive Symptoms During Pregnancy: Systematic Review %A Wan Mohd Yunus,Wan Mohd Azam %A Matinolli,Hanna-Maria %A Waris,Otto %A Upadhyaya,Subina %A Vuori,Miika %A Korpilahti-Leino,Tarja %A Ristkari,Terja %A Koffert,Tarja %A Sourander,Andre %+ Research Centre for Child Psychiatry, University of Turku, Lemminkäisenkatu 3/Teutori 3. floor, Turku, 20014, Finland, 358 503653447, andsou@utu.fi %K pregnancy %K antenatal depression %K systematic review %K cognitive behavior therapy %K digital interventions %K COVID-19 %D 2022 %7 23.2.2022 %9 Review %J J Med Internet Res %G English %X Background: Studies have shown a high prevalence of depression during pregnancy, and there is also evidence that cognitive behavioral therapy (CBT) is one of the most effective psychosocial interventions. Emerging evidence from randomized controlled trials (RCTs) has shown that technology has been successfully harnessed to provide CBT interventions for other populations. However, very few studies have focused on their use during pregnancy. This approach has become increasingly important in many clinical areas due to the COVID-19 pandemic, and our study aimed to expand the knowledge in this particular clinical area. Objective: Our systematic review aimed to bring together the available research-based evidence on digitalized CBT interventions for depression symptoms during pregnancy. Methods: A systematic review of the Web of Science, Cochrane Central Register of Controlled Trials, CINAHL, MEDLINE, Embase, PsycINFO, Scopus, ClinicalTrials.gov, and EBSCO Open Dissertations databases was carried out from the earliest available evidence to October 27, 2021. Only RCT studies published in English were considered. The PRISMA (Preferred Reporting Items of Systematic Reviews and Meta-analyses) guidelines were followed, and the protocol was registered on the Prospective Register of Systematic Reviews. The risk of bias was assessed using the revised Cochrane risk-of-bias tool for randomized trials. Results: The review identified 7 studies from 5 countries (the United States, China, Australia, Norway, and Sweden) published from 2015 to 2021. The sample sizes ranged from 25 to 1342 participants. The interventions used various technological elements, including text, images, videos, games, interactive features, and peer group discussions. They comprised 2 guided and 5 unguided approaches. Using digitalized CBT interventions for depression during pregnancy showed promising efficacy, with guided intervention showing higher effect sizes (Hedges g=1.21) than the unguided interventions (Hedges g=0.14-0.99). The acceptability of the digitalized CBT interventions was highly encouraging, based on user feedback. Attrition rates were low for the guided intervention (4.5%) but high for the unguided interventions (22.1%-46.5%). A high overall risk of bias was present for 6 of the 7 studies. Conclusions: Our search only identified a small number of digitalized CBT interventions for pregnant women, despite the potential of this approach. These showed promising evidence when it came to efficacy and positive outcomes for depression symptoms, and user feedback was positive. However, the overall risk of bias suggests that the efficacy of the interventions needs to be interpreted with caution. Future studies need to consider how to mitigate these sources of biases. Digitalized CBT interventions can provide prompt, effective, evidence-based interventions for pregnant women. This review increases our understanding of the importance of digitalized interventions during pregnancy, including during the COVID-19 pandemic. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020216159; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=216159 %M 35195532 %R 10.2196/33337 %U https://www.jmir.org/2022/2/e33337 %U https://doi.org/10.2196/33337 %U http://www.ncbi.nlm.nih.gov/pubmed/35195532 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 8 %N 2 %P e19877 %T Use of a Smartphone Self-assessment App for a Tobacco-Induced Disease (COPD, Cardiovascular Diseases, Cancer) Screening Strategy and to Encourage Smoking Cessation: Observational Study %A Stavaux,Edouard %A Goupil,François %A Barreau,Guillaume %A Septans,Anne Lise %A Dautzenberg,Bertrand %A Foulet-Rogé,Armelle %A Padilla,Norbert %A Urban,Thierry %A Denis,Fabrice %+ Institut Inter-Regional de Cancérologie Jean Bernard, 9 rue Beauverger, Le Mans, 72000, France, 33 684190480, f.denis@ilcgroupe.fr %K smoking cessation %K mobile health %K self-assessment, lung cancer %K early detection %K tobacco-induced pathologies %D 2022 %7 23.2.2022 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: Patient self-assessment via a mobile app detects actionable symptoms and has been shown to detect lung cancer relapses early, thereby lengthening survival. Objective: The purpose of this study was to assess the incidence of chief symptoms associated with the main tobacco-induced pathologies in both current and ex-smokers through a self-assessment smartphone app and to evaluate the app’s capacity to encourage users to quit smoking or reduce consumption, as well as its impact on early lung cancer stages at the time of diagnosis. Methods: Current and ex-smokers were recruited through an advertising campaign in Sarthe county (France) proposing the free download of a smartphone app. App users were asked to answer 13 questions related to symptoms associated with tobacco-induced diseases (chronic obstructive pulmonary disease [COPD], cardiovascular diseases, cancer). In the event of any positive answer, a message was displayed recommending the user to consult a physician. In addition, they were asked about smoking cessation intention before and after answering these 13 questions. Finally, incidence of stage 1 or 2 lung cancers diagnosed during the launch period of our application was evaluated by comparing data from various sources to those from the same period during the previous year. Results: Of the 5671 users who were eligible for evaluation, an alert was sent to the majority (4118/5671, 72.6%), with a higher incidence for current smokers (2833/3679, 77.0% vs 1298/1992, 65.2%; P<.001). The most frequent symptoms triggering the notifications were fatigue (2023/5671, 35.7%), cough (1658/5671, 29.2%), dyspnea (1502/5671, 26.5%), and persistent chest pain (1286/5671, 22.7%). Of the current smokers, 14.0% (515/3679) showed symptoms suggesting COPD, 15.5% (571/3679) showed symptoms suggesting stable angina, 12.4% (455/3679) probably had lower extremity artery disease, and 6.8% (249/3679) had possible cancer. Of the users, 36.5% (1343/3679) claimed that they thought about quitting smoking, and 48.7% (1795/3679) had thought about reducing their consumption. Surgery-eligible stage 1 and 2 lung cancer incidence was 24% (14/58) during the study period versus 9% (5/54) during the previous year in Sarthe county (P=.04), whereas it remained unchanged in the neighboring county of Maine-et-Loire. Conclusions: A majority of current and ex-smokers showed worrying symptoms, and the use of a self-assessment smartphone app may drive a majority of smokers toward the intention of smoking cessation or decreasing consumption. A randomized study should be performed to confirm this intention and to support the potential increase of symptomatic lung cancer detection at early, surgery-accessible stages. Trial Registration: ClinicalTrials.gov NCT04048954; https://www.clinicaltrials.gov/ct2/show/NCT04048954 %M 35195530 %R 10.2196/19877 %U https://publichealth.jmir.org/2022/2/e19877 %U https://doi.org/10.2196/19877 %U http://www.ncbi.nlm.nih.gov/pubmed/35195530 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 2 %P e31909 %T Crowdsourced Community Support Resources Among Patients Discharged From the Emergency Department During the COVID-19 Pandemic: Pilot Feasibility Study %A Agarwal,Anish K %A Southwick,Lauren %A Schneider,Rachelle %A Pelullo,Arthur %A Ortiz,Robin %A Klinger,Elissa V %A Gonzales,Rachel E %A Rosin,Roy %A Merchant,Raina M %+ Department of Emergency Medicine, University of Pennsylvania, 3600 Civic Center Boulevard, Philadelphia, PA, 19104, United States, 1 2674280125, Anish.Agarwal@pennmedicine.upenn.edu %K COVID-19 %K mHealth %K CHW %K digital health %K platform %K crowdsource %K support %K community %K health system %K monitoring %K virtual care %K text message %K model %K community health worker %K pilot study %K feasibility %D 2022 %7 23.2.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: The COVID-19 pandemic has placed strains on communities. During this public health crisis, health systems have created remote methods of monitoring symptom progression and delivering care virtually. Objective: Using an SMS text message-based system, we sought to build and test a remote model to explore community needs, connect individuals to curated resources, and facilitate community health worker intervention when needed during the pandemic. The primary aims of this pilot study were to establish the feasibility (ie, engagement with the text line) and acceptability (ie, participant ratings of resources and service) of delivering automated well-being resources via smartphone technology. Methods: Eligible patients (aged 18 years or older, having a cell phone with SMS text messaging capability, and recently visited the emergency department) were identified using the electronic health record. The patients were consented to enroll and begin receiving COVID-19–related information and links to community resources. We collected open-ended and close-ended resource and mood ratings. We calculated the frequencies and conducted a thematic review of the open-ended responses. Results: In 7 weeks, 356 participants were enrolled; 13,917 messages were exchanged including 333 resource ratings (mean 4) and 673 well-being scores (mean 6.8). We received and coded 386 open-ended responses, most of which elaborated upon their self-reported mood score (29%). Overall, 77% (n=274) of our participants rated the platform as a service they would highly recommend to a family member or friend. Conclusions: This approach is designed to broaden the reach of health systems, tailor to community needs in real time, and connect at-risk individuals with robust community health support. %M 35037886 %R 10.2196/31909 %U https://mental.jmir.org/2022/2/e31909 %U https://doi.org/10.2196/31909 %U http://www.ncbi.nlm.nih.gov/pubmed/35037886 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 1 %P e32815 %T Development and Usability of a Text Messaging Program for Women With Gestational Diabetes: Mixed Methods Study %A Blair,Rachel A %A Horn,Christine E %A Dias,Jennifer M %A McDonnell,Marie E %A Seely,Ellen W %+ Division of Endocrinology, Diabetes, and Hypertension, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 221 Longwood Avenue, Boston, MA, 02115, United States, 1 6177329479, rblair4@bwh.harvard.edu %K gestational diabetes mellitus %K SMS text messaging %K mobile phone %K mobile health %K pregnancy %K blood glucose self-monitoring %D 2022 %7 22.2.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Gestational diabetes mellitus (GDM) affects 5%-10% of pregnancies and can lead to serious fetal and maternal complications. SMS text messaging is an effective way to improve diabetes management outside of pregnancy, but has not been well studied in GDM. Objective: This study aimed to perform user experience testing and assess usability and acceptability of an SMS text messaging program (Text 4 Success) for women with GDM. Methods: An automated 2-way texting program was developed. It included (1) reminders to check blood glucose levels, (2) positive feedback to user-reported glucose levels, (3) weekly educational messages, and (4) weekly motivational messages. For the user experience testing, women received simulated messages. For the usability study, women were enrolled in the program and received messages for 2 weeks. All women participated in semistructured interviews. For women in the usability study, data from glucose measuring devices were downloaded to assess adherence to self-monitoring of blood glucose (SMBG), measured as the percentage of recommended SMBG checks performed (a secondary outcome). Results: Ten women participated in user experience testing. Suggestions for optimization included further customization of message timing and minimization of jargon, which were incorporated. Ten women participated in the usability study. All 10 would recommend the program to other women with GDM. Participants liked the immediate feedback to glucose values. Suggestions included further flexibility of messages related to mealtimes and the ability to aggregate blood glucose data into a table or graph. Overall, adherence to SMBG testing was high at baseline (222/238 recommended checks, 93%). In comparing the week prior to the trial with the 2 weeks during the trial, there was a small but statistically insignificant difference (P=.48) in the percentage of recommended SMBG performed (median 93% [25th-75th IQR 89%-100%] vs median 97% [25th-75th IQR 92%-100%]). Conclusions: Overall, women with GDM would recommend the Text 4 Success in GDM program and think it is helpful for GDM self-management. The program was usable and acceptable. The program may be better suited to those who have low levels of adherence to SMBG at baseline or to women at time of their diagnosis of GDM. Adaptations to the program will be made based on user suggestions. Further study of SMS text messaging to improve SMBG in GDM is needed. %M 35191851 %R 10.2196/32815 %U https://humanfactors.jmir.org/2022/1/e32815 %U https://doi.org/10.2196/32815 %U http://www.ncbi.nlm.nih.gov/pubmed/35191851 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 2 %P e31116 %T eHealth Interventions for Treatment and Prevention of Depression, Anxiety, and Insomnia During Pregnancy: Systematic Review and Meta-analysis %A Silang,Katherine A %A Sohal,Pooja R %A Bright,Katherine S %A Leason,Jennifer %A Roos,Leslie %A Lebel,Catherine %A Giesbrecht,Gerald F %A Tomfohr-Madsen,Lianne M %+ Department of Psychology, University of Calgary, 2500 University Drive, NW, Calgary, AB, T2N 1N4, Canada, 1 403 220 2243, ltomfohr@ucalgary.ca %K eHealth %K pregnancy %K depression %K anxiety %K insomnia %K mobile phone %D 2022 %7 21.2.2022 %9 Review %J JMIR Ment Health %G English %X Background: Pregnancy is associated with an increased risk for depression, anxiety, and insomnia. eHealth interventions provide a promising and accessible treatment alternative to face-to-face interventions. Objective: The objective of this systematic review and meta-analysis is to determine the effectiveness of eHealth interventions in preventing and treating depression, anxiety, and insomnia during pregnancy. Secondary aims are to identify demographic and intervention moderators of effectiveness. Methods: A total of 5 databases (PsycINFO, Medline, CINAHL, Embase, and Cochrane) were searched from inception to May 2021. Terms related to eHealth, pregnancy, randomized controlled trials (RCTs), depression, anxiety, and insomnia were included. RCTs and pilot RCTs were included if they reported an eHealth intervention for the prevention or treatment of depression, anxiety, or insomnia in pregnant women. Study screening, data extractions, and quality assessment were conducted independently by 2 reviewers from an 8-member research team (KAS, PRS, Hangsel Sanguino, Roshni Sohail, Jasleen Kaur, Songyang (Mark) Jin, Makayla Freeman, and Beatrice Valmana). Random-effects meta-analyses of pooled effect sizes were conducted to determine the effect of eHealth interventions on prenatal mental health. Meta-regression analyses were conducted to identify potential moderators. Results: In total, 17 studies were included in this review that assessed changes in depression (11/17, 65%), anxiety (10/17, 59%), and insomnia (3/17, 18%). Several studies included both depression and anxiety symptoms as outcomes (7/17, 41%). The results indicated that during pregnancy, eHealth interventions showed small effect sizes for preventing and treating symptoms of anxiety and depression and a moderate effect size for treating symptoms of insomnia. With the exception of intervention type for the outcome of depressive symptoms, where mindfulness interventions outperformed other intervention types, no significant moderators were detected. Conclusions: eHealth interventions are an accessible and promising resource for treating symptoms of anxiety, depression, and insomnia during pregnancy. However, more research is necessary to identify ways to increase the efficacy of eHealth interventions for this population. Trial Registration: PROSPERO (International Prospective Register of Systematic Reviews) CRD42020205954; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=205954 %M 35188471 %R 10.2196/31116 %U https://mental.jmir.org/2022/2/e31116 %U https://doi.org/10.2196/31116 %U http://www.ncbi.nlm.nih.gov/pubmed/35188471 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 5 %N 1 %P e30340 %T Parents’ Experience With a Mobile Health Intervention to Influence Human Papillomavirus Vaccination Decision Making: Mixed Methods Study %A Becker,Elisabeth RB %A Shegog,Ross %A Savas,Lara S %A Frost,Erica L %A Coan,Sharon P %A Healy,C Mary %A Spinner,Stanley W %A Vernon,Sally W %+ University of Texas Health Science Center at Houston, 7000 Fannin St., Houston, TX, 77030, United States, 1 (713) 500 9677, elisabethrbecker@gmail.com %K human papillomavirus %K vaccination %K user experience %K parent %K mHealth %K HPV %K vaccine %K HPV vaccine %K parenting %K pediatrics %K sexual health %K cervical cancer %K adolescents %K mHealth %K app %K application %D 2022 %7 21.2.2022 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Human papillomavirus (HPV)-attributed cancers are preventable, yet HPV vaccination rates severely lag behind other adolescent vaccinations. HPVcancerFree (HPVCF) is a mobile health (mHealth) intervention developed to influence parental HPV vaccination decision making by raising awareness of HPV, reducing HPV vaccination barriers, and enabling HPV vaccination scheduling and reminders through a smartphone app. Evaluating the user experience of mHealth interventions is a vital component in assessing their quality and success but tends to be underreported in mHealth intervention evaluation. Objective: We aimed to evaluate the user experience of HPVCF, an HPV cancer prevention app designed for a pediatric clinic network, using mixed methods data collected from log files, survey measures, and qualitative feedback. Methods: Study data were evaluated from parents in a large US pediatric clinic network using HPVCF in the treatment study condition of a group randomized controlled trial. Log data captured HPVCF retention and use. Postintervention rating scales and items assessed HPVCF utility, usefulness, understandability, appeal, credibility, and perceived impact. Overall quality was evaluated using the user version of the Mobile Application Rating Scale (uMars). Open-ended responses assessed parent recommendations for HPVCF enhancement. Results: The 98 parents were mainly female (n=94, 96%), 41 (5.67) years of age, college educated (n=55, 56%), and White and non-Hispanic (n=55, 56%) and had private health insurance for their children (n=75, 77%). Parents used HPVCF 197 times, with the average visit duration approximating 3.5 minutes. The uMARS app quality score was positively skewed (4.2/5.0). Mean ratings were highest for information (4.46 [SD 0.53]) and lowest for engagement (3.74 [SD 0.69]). In addition, of 95 parents, 45 (47%) rated HPVCF as helpful in HPV vaccination decision making and 16 (17%) attributed HPV vaccine initiation to HPVCF. Parents reported that HPVCF increased their awareness (84/95, 88%), knowledge (84/95, 88%), and HPV vaccination intentions (64/95, 67%). Most of the 98 parents rated the 4 HPVCF components as useful (72-92 [73%-94%]). Parents also agreed that HPVCF is clear (86/95, 91%), accurate (86/95, 91%), and more helpful than other HPV vaccine information they had received (89/95, 94%) and that they would recommend it to others (81/95, 85%). In addition, parents suggested ways to increase awareness and engagement with the app, along with opportunities to enhance the content and functionality. Conclusions: HPVCF was well received by parents and performed well on indicators of quality, usefulness, utility, credibility, and perceived impact. This study contributes a multimethod and multimeasure evaluation to the growing body of literature focused on assessing the user experience of patient-focused technology-mediated applications for HPV education. %M 35188469 %R 10.2196/30340 %U https://pediatrics.jmir.org/2022/1/e30340 %U https://doi.org/10.2196/30340 %U http://www.ncbi.nlm.nih.gov/pubmed/35188469 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 2 %P e30974 %T Web-Based Lifestyle Interventions for Survivors of Cancer: Usability Study %A Williams,Victoria %A Brown,Nashira %A Moore,Justin Xavier %A Farrell,David %A Perumean-Chaney,Suzanne %A Schleicher,Erica %A Fontaine,Kevin %A Demark-Wahnefried,Wendy %A Pekmezi,Dori %+ Department of Health Behavior, University of Alabama at Birmingham, 1665 University Boulevard, Birmingham, AL, 35233, United States, 1 205 934 4993, contact@drvaw.com %K cancer survivors %K diet %K exercise %K lifestyle %K internet %K physical activity %K web-based %K website %K weight management %K digital health %K cancer %K online health %D 2022 %7 21.2.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Internet-based lifestyle programs are increasingly being used to deliver health behavior change interventions to survivors of cancer. However, little is known about website use in this population or its association with healthy lifestyle changes. Objective: The aim of this study is to describe lifestyle intervention website use (log-ins, time on website, and page views) among survivors of cancer and patterns of use by participant characteristics. In addition, associations were explored between website use and changes in healthy lifestyle knowledge and practice. Methods: A total of 35 survivors of cancer were recruited between August 2017 and 2018 to participate in a 2-week, single-arm pilot test of the SurvivorSHINE lifestyle intervention website. Knowledge and practices related to healthy diet and physical activity behaviors were measured at baseline and follow-up. Website use (eg, time spent on the website, frequency of log-ins, and page views) were collected from the SurvivorSHINE administrative site during the intervention period. Patterns of use were examined by participants’ gender and race. Correlations between website use and changes in healthy lifestyle knowledge, physical activity, diet, and weight were explored. Mann–Whitney U tests were used to compare demographic factors on website use. Results: Participants logged into the SurvivorSHINE intervention website an average of 3.2 (SD 2) times over the 2-week period and spent a total average of 94 (SD 56) minutes viewing the website during the intervention. Examining website activity, 1905 page views were logged. The User Profile (344 page views) and Home sections (301 page views) were the most frequently visited components. No associations were observed between the frequency of log-ins or the total time on the website, improvements in knowledge related to healthy lifestyles, or changes in body weight or dietary intake. However, the total time on the website was positively correlated with improvements in accelerometer-measured physical activity (r=0.74; P=.02) and self-reported physical activity (r=0.35; P=.04). Conclusions: Survivors of cancer demonstrated clear interest in a diet and exercise intervention website, as evidenced by their frequency of log-ins, page views on numerous features, and total viewing time. Moreover, increased website use was correlated with improvements in physical activity. %M 35188468 %R 10.2196/30974 %U https://formative.jmir.org/2022/2/e30974 %U https://doi.org/10.2196/30974 %U http://www.ncbi.nlm.nih.gov/pubmed/35188468 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 2 %P e34889 %T A Digital Mental Health Intervention in an Orthopedic Setting for Patients With Symptoms of Depression and/or Anxiety: Feasibility Prospective Cohort Study %A Leo,Ashwin J %A Schuelke,Matthew J %A Hunt,Devyani M %A Metzler,John P %A Miller,J Philip %A Areán,Patricia A %A Armbrecht,Melissa A %A Cheng,Abby L %+ Division of Physical Medicine and Rehabilitation, Department of Orthopedic Surgery, Washington University in St Louis School of Medicine, 660 South Euclid Avenue, St Louis, MO, 63110, United States, 1 3147472823, chengal@wustl.edu %K digital health %K mental health %K depression %K anxiety %K chronic pain %K musculoskeletal %K orthopedic %K pain management %K health intervention %K mobile phone %D 2022 %7 21.2.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Symptoms of depression and anxiety commonly coexist with chronic musculoskeletal pain, and when this occurs, standard orthopedic treatment is less effective. However, mental health intervention is not yet a routine part of standard orthopedic treatment, in part because of access-related barriers. Digital mental health intervention is a potential scalable resource that could be feasibly incorporated into orthopedic care. Objective: This study’s primary purpose was to assess the feasibility of introducing a digital mental health intervention (Wysa) in an outpatient orthopedic setting to patients with coexisting symptoms of depression and/or anxiety. The secondary purpose was to perform a preliminary effectiveness analysis of the intervention. Methods: In this single-arm, prospective cohort study, participants included adult patients (18 years and older) who presented to a nonsurgical orthopedic specialist at a single tertiary care academic center for evaluation of a musculoskeletal condition and who self-reported symptoms of depression and/or anxiety (Patient-Reported Outcomes Measurement Information System [PROMIS] Depression and/or Anxiety score ≥55). Face-to-face enrollment was performed by a research coordinator immediately after the participant’s encounter with an orthopedic clinician. Participants were provided 2 months of access to a mobile app called Wysa, which is an established, multicomponent digital mental health intervention that uses chatbot technology and text-based access to human counselors to deliver cognitive behavioral therapy, mindfulness training, and sleep tools, among other features. For this study, Wysa access also included novel, behavioral activation–based features specifically developed for users with chronic pain. Primary feasibility outcomes included the study recruitment rate, retention rate, and engagement rate with Wysa (defined as engagement with a therapeutic Wysa tool at least once during the study period). Secondary effectiveness outcomes were between-group differences in mean longitudinal PROMIS mental and physical health score changes at 2-month follow-up between high and low Wysa users, defined by a median split. Results: The recruitment rate was 29.3% (61/208), retention rate was 84% (51/61), and engagement rate was 72% (44/61). Compared to low users, high users reported greater improvement in PROMIS Anxiety scores (between-group difference −4.2 points, 95% CI −8.1 to −0.2; P=.04) at the 2-month follow-up. Between-group differences in PROMIS Depression (−3.2 points, 95% CI −7.5 to 1.2; P=.15) and Pain Interference scores (−2.3 points, 95% CI −6.3 to 1.7; P=.26) favored high users but did not meet statistical significance. Improvements in PROMIS Physical Function scores were comparable between groups. Conclusions: Delivery of a digital mental health intervention within the context of orthopedic care is feasible and has the potential to improve mental health and pain-related impairment to a clinically meaningful degree. Participants’ engagement rates exceeded industry standards, and additional opportunities to improve recruitment and retention were identified. Further pilot study followed by a definitive, randomized controlled trial is warranted. Trial Registration: ClinicalTrials.gov NCT04640090; https://clinicaltrials.gov/ct2/show/NCT04640090 %M 35039278 %R 10.2196/34889 %U https://formative.jmir.org/2022/2/e34889 %U https://doi.org/10.2196/34889 %U http://www.ncbi.nlm.nih.gov/pubmed/35039278 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 2 %P e32918 %T Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial %A Farmer,Andrew %A Jones,Louise %A Newhouse,Nikki %A Kenning,Cassandra %A Williams,Nicola %A Chi,Yuan %A Bartlett,Y Kiera %A Plumpton,Catrin %A McSharry,Jenny %A Cholerton,Rachel %A Holmes,Emily %A Robinson,Stephanie %A Allen,Julie %A Gudgin,Bernard %A Velardo,Carmelo %A Rutter,Heather %A Horne,Rob %A Tarassenko,Lionel %A Williams,Veronika %A Locock,Louise %A Rea,Rustam %A Yu,Ly-Mee %A Hughes,Dyfrig %A Bower,Peter %A French,David %+ Nuffield Department of Primary Care Health Sciences, University of Oxford, Gibson Building, Radcliffe Observatory Quarter, Oxford, OX2 6GG, United Kingdom, 44 1865 617942, andrew.farmer@phc.ox.ac.uk %K diabetes %K SMS text messages %K cardiovascular risk prevention %K medication adherence %K digital health %K randomized controlled trial %D 2022 %7 21.2.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Type 2 diabetes is a common lifelong condition that affects over 400 million people worldwide. The use of effective medications and active self-management can reduce the risk of serious complications. However, people often have concerns when starting new medications and face difficulties in taking their medications regularly. Support provided by brief messages delivered through mobile phone–based SMS text messages can be effective in some long-term conditions. We have identified promising behavior change techniques (BCTs) to promote medication adherence in this population via a systematic review and developed SMS text messages that target these BCTs. Feasibility work has shown that these messages have fidelity to intended BCTs, are acceptable to patients, and are successful in changing the intended determinants of medication adherence. We now plan to test this intervention on a larger scale in a clinical trial. Objective: The aim of this trial is to determine the effectiveness and cost-effectiveness of this intervention for reducing cardiovascular risk in people with type 2 diabetes by comparing it with usual care. Methods: The trial will be a 12-month, multicenter, individually randomized controlled trial in primary care and will recruit adults (aged ≥35 years) with type 2 diabetes in England. Consenting participants will be randomized to receive short SMS text messages intended to affect a change in medication adherence 3 to 4 times per week in addition to usual care. The aim is to test the effectiveness and cost-effectiveness of the intervention when it is added to usual care. The primary clinical outcome will be a composite cardiovascular risk measure. Data including patient-reported measures will be collected at baseline, at 13 and 26 weeks, and at the end of the 12-month follow-up period. With 958 participants (479 in each group), the trial is powered at 92.5% to detect a 4–percentage point difference in cardiovascular risk. The analysis will follow a prespecified plan. A nested quantitative and qualitative process analysis will be used to examine the putative mechanisms of behavior change and wider contextual influences. A health economic analysis will be used to assess the cost-effectiveness of the intervention. Results: The trial has completed the recruitment phase and is in the follow-up phase. The publication of results is anticipated in 2024. Conclusions: This trial will provide evidence regarding the effectiveness and cost-effectiveness of this intervention for people with type 2 diabetes. Trial Registration: ISRCTN Registry ISRCTN15952379; https://www.isrctn.com/ISRCTN15952379 International Registered Report Identifier (IRRID): DERR1-10.2196/32918 %M 35188478 %R 10.2196/32918 %U https://www.researchprotocols.org/2022/2/e32918 %U https://doi.org/10.2196/32918 %U http://www.ncbi.nlm.nih.gov/pubmed/35188478 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 10 %N 1 %P e31570 %T A Serious Puzzle Game to Enhance Adherence to Antirheumatic Drugs in Patients With Rheumatoid Arthritis: Systematic Development Using Intervention Mapping %A Pouls,Bart PH %A Bekker,Charlotte L %A van Dulmen,Sandra %A Vriezekolk,Johanna E %A van den Bemt,Bart JF %+ Department of Rheumatology Research, Sint Maartenskliniek, Hengstdal 3, Nijmegen, 6574NA, Netherlands, 31 612502678, b.pouls@maartenskliniek.nl %K medication adherence %K serious game %K eHealth %K rheumatoid arthritis %K intervention mapping %K intervention development %D 2022 %7 18.2.2022 %9 Original Paper %J JMIR Serious Games %G English %X Background: Patients’ implicit attitudes toward medication need and concerns may influence their adherence. Targeting these implicit attitudes by combining game-entertainment with medication-related triggers might improve medication adherence in patients with rheumatoid arthritis (RA). Objective: The aim of this study was to describe the systematic development of a serious game to enhance adherence to antirheumatic drugs by using intervention mapping. Methods: A serious game was developed using the intervention mapping framework guided by a multidisciplinary expert group, which proceeded along 6 steps: (1) exploring the problem by assessing the relationship between medication adherence and implicit attitudes, (2) defining change objectives, (3) selecting evidence-based behavior change techniques that focused on adjusting implicit attitudes, (4) designing the intervention, (5) guaranteeing implementation by focusing on intrinsic motivation, and (6) planning a scientific evaluation. Results: Based on the problem assessment and guided by the Dual-Attitude Model, implicit negative and illness-related attitudes of patients with RA were defined as the main target for the intervention. Consequently, the change objective was “after the intervention, participants have a more positive attitude toward antirheumatic drugs.” Attention bias modification, evaluative conditioning, and goal priming were the techniques chosen to implicitly target medication needs. These techniques were redesigned into medication-related triggers and built in the serious puzzle game. Thirty-seven patients with RA tested the game at several stages. Intrinsic motivation was led by the self-determination theory and addressed the 3 needs, that is, competence, autonomy, and relatedness. The intervention will be evaluated in a randomized clinical trial that assesses the effect of playing the serious game on antirheumatic drug adherence. Conclusions: We systematically developed a serious game app to enhance adherence to antirheumatic drugs among patients with RA by using the intervention mapping framework. This paper could serve as a guideline for other health care providers when developing similar interventions. %M 35179510 %R 10.2196/31570 %U https://games.jmir.org/2022/1/e31570 %U https://doi.org/10.2196/31570 %U http://www.ncbi.nlm.nih.gov/pubmed/35179510 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 2 %P e33603 %T Consistency With and Disengagement From Self-monitoring of Weight, Dietary Intake, and Physical Activity in a Technology-Based Weight Loss Program: Exploratory Study %A Carpenter,Chelsea A %A Eastman,Abraham %A Ross,Kathryn M %+ Department of Clinical and Health Psychology, College of Public Health and Health Professions, University of Florida, PO Box 100165, Gainesville, FL, 32610, United States, 1 (352) 294 8433, kmross@phhp.ufl.edu %K self-monitoring %K adherence %K weight loss %K digital tools %K mobile phone %D 2022 %7 18.2.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital self-monitoring tools offer promise to improve adherence to self-monitoring of weight and weight-related behaviors; however, less is known regarding the patterns of participant consistency and disengagement with these tools. Objective: This study characterizes the consistency of use and time to disengagement with digital self-monitoring tools during a 6-month weight loss intervention and investigates whether the provision of phone-based intervention improved self-monitoring adherence. Methods: Participants were 54 adults with overweight or obesity (mean age 49.6 years, SD 12.4 years; mean BMI 32.6 kg/m2, SD 3.2 kg/m2) enrolled in a pilot trial assessing the impact of self-monitoring technology (Fitbit Zip, Aria scale, and smartphone app), with and without additional interventionist contact, on weight loss. All participants received weight loss education and were asked to self-monitor weight, dietary intake, and physical activity daily throughout the 6-month program. Consistency was defined as the number of weeks that participants adhered to self-monitoring recommendations (7 out of 7 days). Disengagement was defined as the first of 2 consecutive weeks that the 7-day self-monitoring adherence goal was not met. Wilcoxon signed-rank tests were used to examine differences in consistency and disengagement by behavioral targets. t tests (2-tailed) and Cox proportional hazards models were used to examine whether providing additional interventionist contact would lead to significant improvements in consistency and time to disengagement from self-monitoring tools, respectively. Linear regressions were used to examine associations between consistency, time to disengagement, and weight loss. Results: Participants consistently self-monitored physical activity for more weeks (mean 17.4 weeks, SD 8.5 weeks) than weight (mean 11.1 weeks, SD 8.5 weeks) or dietary intake (mean 10.8 weeks, SD 8.7 weeks; P<.05). Similarly, participants had a significantly longer time to disengagement from self-monitoring of physical activity (median 19.5 weeks) than weight (4 weeks) or dietary intake (10 weeks; P<.001). Participants randomized to receive additional interventionist contact had significantly greater consistency and longer time to disengagement for self-monitoring of dietary intake compared with participants who did not (P=.006); however, there were no statistically significant differences between groups for self-monitoring of weight or physical activity (P=.24 and P=.25, respectively). Greater consistency and longer time to disengagement were associated with greater weight loss for self-monitoring of weight and dietary intake (P<.001 and P=.004, respectively) but not for physical activity (P=.57). Conclusions: Results demonstrated that self-monitoring adherence differed by behavioral target, with greater consistency and longer time to disengagement associated with lower-burden tools (ie, self-monitoring of physical activity). Consistent with supportive accountability theory, additional interventionist contact improved consistency and lengthened time to disengagement from self-monitoring of dietary intake. Given the observed associations between consistency, disengagement, and weight loss outcomes, it is important to identify additional methods of increasing consistency and engagement with digital self-monitoring tools. %M 35179513 %R 10.2196/33603 %U https://formative.jmir.org/2022/2/e33603 %U https://doi.org/10.2196/33603 %U http://www.ncbi.nlm.nih.gov/pubmed/35179513 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e25948 %T Positive Coping as a Mediator of Mobile Health Intervention Effects on Quality of Life Among People Living With HIV: Secondary Analysis of the Randomized Controlled Trial Run4Love %A Zeng,Yu %A Guo,Yan %A Ho,Rainbow Tin Hung %A Zhu,Mengting %A Zeng,Chengbo %A Monroe-Wise,Aliza %A Li,Yiran %A Qiao,Jiaying %A Zhang,Hanxi %A Cai,Weiping %A Li,Linghua %A Liu,Cong %+ Department of Medical Statistic, School of Public Health, Sun Yat-sen University, Guangzhou, China, 86 020 87334202, Yan.Guo1@umassmed.edu %K mediation effect %K mobile health %K quality of life %K positive coping %K HIV %K randomized controlled trial %D 2022 %7 17.2.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The effectiveness of psychosocial interventions on quality of life (QOL) among people living with HIV has been validated, including mobile health (mHealth) interventions. However, it is unclear which components of such interventions account for these effects. Objective: This study aims to examine positive coping as a potential mediator of the effects of an mHealth intervention on QOL among people living with HIV. Methods: For this secondary analysis, we used data from an mHealth-based randomized controlled trial, Run4Love, which was conducted to improve QOL and mental health outcomes of people living with HIV. A total of 300 participants were randomly assigned to the intervention group to receive the adapted cognitive-behavioral stress management courses and regular physical activity promotion or the waitlist control group in a 1:1 ratio. Our analysis focused on positive coping and QOL, which were repeatedly measured at baseline and at 3-, 6-, and 9-month follow-ups. Latent growth curve models were constructed to explore the mediating role of positive coping in the effects of the mHealth intervention on QOL. Results: Positive coping served as a mediator in the effect of the mHealth intervention on QOL for up to 9 months. The mHealth intervention had a significant and positive indirect effect on the slope of QOL via the slope of positive coping (b=2.592×1.620=4.198, 95% CI 1.189-7.207, P=.006). The direct effect of the intervention was not significant (b=0.552, 95% CI −2.154 to 3.258, P=.69) when controlling for the mediator. Conclusions: The longitudinal findings suggest that positive coping could be a crucial mediator of the mHealth intervention in enhancing QOL among people living with HIV. These findings underscore the importance of improving positive coping skills in mHealth interventions to improve QOL among people living with HIV. %M 35175209 %R 10.2196/25948 %U https://www.jmir.org/2022/2/e25948 %U https://doi.org/10.2196/25948 %U http://www.ncbi.nlm.nih.gov/pubmed/35175209 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 5 %N 1 %P e27615 %T Effectiveness of Pediatric Teleconsultation to Prevent Skin Conditions in Infants and Reduce Parenting Stress in Mothers: Randomized Controlled Trial %A Ando,Tomohisa %A Mori,Rintaro %A Takehara,Kenji %A Asukata,Mari %A Ito,Shuichi %A Oka,Akira %+ Department of Health Policy, National Center for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo, 157-8535, Japan, 81 334170181, ando-tm@ncchd.go.jp %K teleconsultation %K email newsletters %K eHealth %K pediatrician %K infant %K mother %K atopic dermatitis %K parenting stress %K randomized controlled trial %K stress %K dermatitis %K parenting %K pediatrics %K email %K children %K Japan %D 2022 %7 17.2.2022 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: In Japan, eHealth for infants and mothers is currently an important aspect, but its effectiveness has rarely been examined. For infants, skin problems, including atopic dermatitis (AD), which is known to lead to other allergic diseases, are one of the most common conditions. Mothers of infants are prone to experiencing parenting stress, which adversely affects mothers’ and children’s well-being. Additionally, studies have reported that AD among offspring enhances parenting stress, and postnatal maternal psychological problems can increase the risk of AD in children. Objective: This study evaluated the effectiveness of pediatric teleconsultation for preventing AD in infants and reducing parenting stress in mothers in Japan. Methods: The study was an open-label, randomized, parallel-armed controlled trial. In total, 318 pairs of infants and mothers in the Yokohama City Sakae Ward were recruited when they submitted birth cards to the ward, received the explanation about the trial, and provided informed consent on the website for this trial. Eligible pairs of infants and mothers were randomly assigned to the intervention group (n=140) or the control group (n=138). Participants in the intervention and control groups received routine postnatal care from local government services. In addition, participants in the intervention group had the option to combine routine pediatric services with teleconsultation and email newsletters without charge from the date of registration until the infant turned 4 months. Primary outcomes were (1) the prevalence of AD in infants diagnosed based on the United Kingdom Working Party criteria and (2) parenting stress and mental status of mothers assessed using the Parenting Stress Index-Short Form (PSI-SF) and General Health Questionnaire-12 (GHQ-12). Data were collected by the ward office staff and researcher during the 4-month checkup. Results: The prevalence of AD in infants was significantly lower in the intervention group than in the control group during the 4-month checkup (20% vs 33%, P=.02; relative risk ratio, 0.709 [95% CI 0.519-0.969]). No significant differences were observed in the PSI-SF and GHQ-12 scores between the 2 groups. There was a significant difference in the prevalence of AD between participants who used teleconsultation services and email newsletters, participants who did not use teleconsultation services but received email newsletters, and participants who neither received nor used either service (18% vs 22% vs 33%, P=.048). Conclusions: This is the first randomized controlled trial demonstrating that routine pediatric care combined with teleconsultation and email newsletters was effective in reducing the prevalence of AD in infants. The findings highlight the potential of pediatric eHealth to become a useful new strategy for preventing AD. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000029774; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034022 %M 34678753 %R 10.2196/27615 %U https://pediatrics.jmir.org/2022/1/e27615 %U https://doi.org/10.2196/27615 %U http://www.ncbi.nlm.nih.gov/pubmed/34678753 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 2 %P e32716 %T Think-Aloud Testing of a Novel Safer Drinking App for College Students During COVID-19: Usability Study %A Smith,Jessica Gomez %A Alamiri,Nour Sami %A Biegger,Grace %A Frederick,Christina %A Halbert,Jennifer P %A Ingersoll,Karen S %+ Center for Behavioral Health & Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, 560 Ray C Hunt Dr, Charlottesville, VA, 22903, United States, 1 434 243 0581, KES7A@hscmail.mcc.virginia.edu %K app development %K college binge drinking %K think aloud testing %K formative research %K mobile phone %D 2022 %7 17.2.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Hazardous alcohol consumption, and binge drinking in particular, continues to be common among college students, posing the greatest risk for their health and safety. Despite widespread exposure to evidence-based preventive interventions among US undergraduates, only modest and temporary effects on risky drinking occur. Formative studies have demonstrated that students want a more engaging intervention tool for risky drinking that can be used just in time. Objective: The purpose of this study is to test the appeal, relevance, and perceived utility of a draft mobile app for safer student drinking at a public university in Virginia. Methods: Undergraduate student participants tested the draft mobile app via a web-based prototype that tailors to individual feedback with hot spots that responded to their taps to mimic app functionality. They narrated their impressions, navigation, and comments in a standardized think-aloud procedure. After each round of think-aloud interviews, researchers debriefed the investigators and developers to discuss findings and brainstorm app modifications. Results: Minor changes to the functionality and aesthetics would improve usability of the app (eg, option for light mode in app settings). Student testers recommended tailoring the app to the needs of college students and to aspects of the local university’s drinking culture. Conclusions: Findings from this study will be synthesized with information gained from other formative work to determine the final app features. We will test the app in a pilot randomized trial to assess app use and the impact of the app on college student drinking behavior over several months. %M 35175210 %R 10.2196/32716 %U https://formative.jmir.org/2022/2/e32716 %U https://doi.org/10.2196/32716 %U http://www.ncbi.nlm.nih.gov/pubmed/35175210 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e28093 %T Remotely Delivered Interventions to Support Women With Symptoms of Anxiety in Pregnancy: Mixed Methods Systematic Review and Meta-analysis %A Evans,Kerry %A Rennick-Egglestone,Stefan %A Cox,Serena %A Kuipers,Yvonne %A Spiby,Helen %+ School of Health Sciences, University of Nottingham, Queen's Medical Centre, Derby Rd, Lenton, Nottingham, NG7 2HA, United Kingdom, 44 7596783920, kerry.evans1@nottingham.ac.uk %K anxiety %K pregnancy %K antenatal %K systematic review %K digital interventions %K eHealth %K remote interventions %K electronic health %K parenting %K remote delivery %K therapy %K CBT %K fear %K distress %K mobile phone %D 2022 %7 15.2.2022 %9 Review %J J Med Internet Res %G English %X Background: Symptoms of anxiety are common in pregnancy, with severe symptoms associated with negative outcomes for women and babies. Low-level psychological therapy is recommended for women with mild to moderate anxiety, with the aim of preventing an escalation of symptoms and providing coping strategies. Remotely delivered interventions have been suggested to improve access to treatment and support and provide a cost-effective, flexible, and timely solution. Objective: This study identifies and evaluates remotely delivered, digital, or web-based interventions to support women with symptoms of anxiety during pregnancy. Methods: This mixed methods systematic review followed a convergent segregated approach to synthesize qualitative and quantitative data. The ACM Digital Library, Allied and Complementary Medicine Database, Applied Social Sciences Index and Abstracts, Centre for Reviews and Dissemination database, the Cochrane Central Register of Controlled Trials, the Cochrane Library, CINAHL, Embase, Health Technology Assessment Library, IEEE Xplore, Joanna Briggs Institute, Maternity and Infant Care, MEDLINE, PsycINFO, and the Social Science Citation Index were searched in October 2020. Quantitative or qualitative primary research that included pregnant women and evaluated remotely delivered interventions reporting measures of anxiety, fear, stress, distress, women’s views, and opinions were included. Results: Overall, 3 qualitative studies and 14 quantitative studies were included. Populations included a general antenatal population and pregnant women having anxiety and depression, fear of childbirth, insomnia, and preterm labor. Interventions included cognitive behavioral therapy, problem solving, mindfulness, and educational designs. Most interventions were delivered via web-based platforms, and 62% (8/13) included direct contact from trained therapists or coaches. A meta-analysis of the quantitative data found internet-based cognitive behavioral therapy and facilitated interventions showed a beneficial effect in relation to the reduction of anxiety scores (standardized mean difference −0.49, 95% CI −0.75 to −0.22; standardized mean difference −0.48, 95% CI −0.75 to −0.22). Due to limitations in the amount of available data and study quality, the findings should be interpreted with caution. Synthesized findings found some evidence to suggest that interventions are more effective when women maintain regular participation which may be enhanced by providing regular contact with therapists or peer support, appropriate targeting of interventions involving components of relaxation and cognitive-based skills, and providing sufficient sessions to develop new skills without being too time consuming. Conclusions: There is limited evidence to suggest that women who are pregnant may benefit from remotely delivered interventions. Components of interventions that may improve the effectiveness and acceptability of remotely delivered interventions included providing web-based contact with a therapist, health care professional, or peer community. Women may be more motivated to complete interventions that are perceived as relevant or tailored to their needs. Remote interventions may also provide women with greater anonymity to help them feel more confident in disclosing their symptoms. %M 35166688 %R 10.2196/28093 %U https://www.jmir.org/2022/2/e28093 %U https://doi.org/10.2196/28093 %U http://www.ncbi.nlm.nih.gov/pubmed/35166688 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e28703 %T The Efficacy of a Smartphone-Based App on Stress Reduction: Randomized Controlled Trial %A Hwang,Hyunchan %A Kim,Sun Mi %A Netterstrøm,Bo %A Han,Doug Hyun %+ Department of Psychiatry, College of Medicine, Chung-Ang University, 102 Heukseok-ro, Dongjak-gu, Seoul, 156-756, Republic of Korea, 82 2 6299 1508, hduk70@gmail.com %K stress reduction %K third-wave cognitive behavioral therapy %K individual tailored treatment %K randomized controlled trial %K digital therapeutics %D 2022 %7 15.2.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Stress management in the workplace is essential for a healthy mental and physical state. Due to technological advancements, individually tailored therapy and online cognitive behavioral therapy (CBT) are on the rise. Objective: This study analyzed the efficacy of a smartphone app based on third-wave CBT tailored to an individual. Methods: A randomized controlled trial was conducted with 126 participants who were divided into 2 groups. The intervention group used the smartphone app BetterLife for 10 weeks, while the control group was placed on a waiting list for the same duration. The Perceived Stress Scale–10 (PSS), Korean Utrecht Work Engagement Scale–9 (UWES), World Health Organization Quality of Life Assessment (WHOQOL), Beck Depression Inventory–II (BDI), and Beck Anxiety Inventory (BAI) were administered at baseline and after 10 weeks to both groups. Results: Of the 126 participants, 11 dropped out during the trial. A 2-way repeated measure analysis of covariance was conducted, controlling for baseline BDI. There were greater improvements in PSS (F=24.33, P<.001, η2=0.17) and UWESK scores (F=8.32, P=.0046, η2=0.06) in the intervention group than in the control group. WHOQOL scores exhibited statistically significant improvement in the intervention group in the overall quality of life (F=8.19, P=.0049, η2=0.06), physical health (F=8.87, P=.003, η2=0.07), psychological health (F=13.32, P<.001, η2=0.10), social relationships (F=19.43, P<.001, η2=0.14), and environmental domains (F=10.14, P=.002, η2=0.08) but not overall health (F=1.68, P=.20). BDI (F=7.17, P=.008, η2=0.06) and BAI (F=6.00, P=.02, η2=0.05) showed a statistically significant improvement in the intervention group, but this significance did not survive the Bonferroni correction (P<.005). Conclusions: These results provide evidence that smartphone-based CBT is a viable option for reducing stress in the workplace. Trial Registration: Clinical Research Information Service KCT0003231; https://cris.nih.go.kr/cris/search/detailSearch.do/15137 %M 35166687 %R 10.2196/28703 %U https://www.jmir.org/2022/2/e28703 %U https://doi.org/10.2196/28703 %U http://www.ncbi.nlm.nih.gov/pubmed/35166687 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 2 %P e32251 %T Effects on Adherence to a Mobile App–Based Self-management Digital Therapeutics Among Patients With Coronary Heart Disease: Pilot Randomized Controlled Trial %A Li,Yuxi %A Gong,Yanjun %A Zheng,Bo %A Fan,Fangfang %A Yi,Tieci %A Zheng,Yimei %A He,Pengkang %A Fang,Jin %A Jia,Jia %A Zhu,Qin %A Jiang,Jie %A Huo,Yong %+ Department of Cardiology, Peking University First Hospital, Xishiku No. 8, Xicheng District, Beijing, 100034, China, 86 83572283, huoyong@263.net.cn %K coronary heart disease %K secondary prevention %K self-management %K mobile app %K adherence %K digital therapeutics %K mobile phone %D 2022 %7 15.2.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The adherence to secondary prevention treatment in patients with coronary heart disease (CHD) is low. Digital therapeutics (DTx) refers to an emerging branch of medicine that delivers medical interventions directly to patients using evidence-based, clinically evaluated, technology-based software algorithms or apps to facilitate disease management, which may be an efficient tool to optimize adherence. Objective: This paper aims to investigate the effect of mobile app–based self-management DTx on long-term use of secondary prevention medications in patients with CHD in China. Methods: This pilot study was a parallel-designed, open-labeled, single-center, randomized controlled trial. Hospitalized patients with CHD admitted to Peking University First Hospital between April 2016 and June 2017 were randomized before discharge on a 1:1 ratio. The intervention group received regular follow-up combined with DTx, which is a self-management mobile app already installed on an Android 5 (Mi Pad 1, Xiaomi Corporation) tablet. Structured data from the hospital informatics system were integrated automatically, and medication, lifestyle intervention plan, follow-up protocol, and patient education materials were also provided according to the diagnosis. Participants could use DTx for self-management at home. The control group was under conventional hospital–based follow-up care. Patients were followed up for 1 year, and the primary end point was the percentage of all guideline-recommended medications at 12 months. The secondary end points included the percentage adhered to standard secondary prevention medications at 6 months, the control rate of lipid profile, and blood pressure at 6 months and 1 year. Results: Among 300 randomized patients with CHD, 290 (96.7%) were included in the final analysis, including 49.3% (143/290) and 50.7% (147/290) of patients from the intervention and control groups, respectively. Baseline characteristics were similar between the 2 groups. There was a statistically significant improvement in the percentage of all guideline-recommended medications at 12 months in the intervention group compared with the control group (relative risk [RR] 1.34, 95% CI 1.12-1.61; P=.001), and there was no interaction with baseline characteristics. The intervention group had a significantly higher proportion of patients achieving blood pressure under control (systolic blood pressure <140 mm Hg and diastolic blood pressure <90 mm Hg) and low-density lipoprotein cholesterol <1.8 mmol/L (RR 1.45, 95% CI 1.22-1.72; P<.001 and RR 1.40, 95% CI 1.11-1.75; P=.004, respectively) at 12 months. Furthermore, on logistic regression, the intervention group had a lower risk of withdrawing from guideline-recommended medications (odds ratio 0.46, 95% CI 0.27-0.78; P=.004). Conclusions: Among patients with CHD, using a mobile app–based self-management DTx in addition to traditional care resulted in a significant improvement in guideline-recommended medication adherence at 12 months. The results of the trial will be applicable to primary care centers, especially in rural areas with less medical resources. Trial Registration: ClinicalTrials.gov NCT03565978; https://clinicaltrials.gov/ct2/show/NCT03565978 %M 34906924 %R 10.2196/32251 %U https://mhealth.jmir.org/2022/2/e32251 %U https://doi.org/10.2196/32251 %U http://www.ncbi.nlm.nih.gov/pubmed/34906924 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e30675 %T Digital Health Interventions for Weight Management in Children and Adolescents: Systematic Review and Meta-analysis %A Kouvari,Matina %A Karipidou,Melina %A Tsiampalis,Thomas %A Mamalaki,Eirini %A Poulimeneas,Dimitrios %A Bathrellou,Eirini %A Panagiotakos,Demosthenes %A Yannakoulia,Mary %+ Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Eleftheriou Venizelou 70, Athens, 17671, Greece, 30 6944362633, myianna@hua.gr %K childhood obesity %K eHealth %K mHealth %K digital health %K youth %K mobile phone %D 2022 %7 14.2.2022 %9 Review %J J Med Internet Res %G English %X Background: Recent meta-analyses suggest the use of technology-based interventions as a treatment option for obesity in adulthood. Similar meta-analytic approaches for children are scarce. Objective: The aim of this meta-analysis is to examine the effect of technology-based interventions on overweight and obesity treatment in children and adolescents. Methods: A systematic literature search was performed using MEDLINE (PubMed), Scopus, and Cochrane Library for randomized clinical trials to identify interventional studies published between January 2000 and February 2021. Results: In total, 9 manuscripts from 8 clinical trials of 582 children or adolescents were considered eligible. BMI, BMI z-score, and other BMI-related baseline metrics during and after intervention were considered as primary outcomes. In 7 of 8 studies, a technology-based intervention was applied in addition to conventional care. Of the 8 studies, 6 studies were conducted in the United States, 1 in Australia, and 1 in northwestern Europe. In total, 5 studies included adolescents, whereas the rest addressed children aged 9 to 12 years. Intervention duration ranged from 3 to 24 months. Significant differences between groups in BMI metric changes were reported by 5 of the 8 studies. Pooled analysis revealed an overall significant decrease in BMI metrics in the intervention group (standardized mean difference –0.61, 95% CI –1.10 to –0.13; P=.01). Subgroup analysis revealed that significance was lost in case of no parental involvement (standardized mean difference –0.36, 95% CI –0.83 to 0.11; P=.14). The small number of clinical trials found, the varying study quality, and the study heterogeneity are some limitations of this review. Conclusions: The studies reported herein describe functional and acceptable technology-based approaches, in addition to conventional treatments, to enhance weight loss in young populations. %M 35156934 %R 10.2196/30675 %U https://www.jmir.org/2022/2/e30675 %U https://doi.org/10.2196/30675 %U http://www.ncbi.nlm.nih.gov/pubmed/35156934 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e27584 %T Internet-Based Audiologist-Guided Cognitive Behavioral Therapy for Tinnitus: Randomized Controlled Trial %A W Beukes,Eldré %A Andersson,Gerhard %A Fagelson,Marc %A Manchaiah,Vinaya %+ Vision and Hearing Research Centre, Anglia Ruskin University, East Road, Cambridge, CB1 1TP, United Kingdom, 44 07951113157, eldre.beukes@aru.co.uk %K tinnitus %K cognitive behavioral therapy %K internet intervention %K web-based intervention %K randomized controlled trial %K telehealth %K teleaudiology %K eHealth %D 2022 %7 14.2.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Tinnitus is a symptom that can be very distressing owing to hearing sounds not related to any external sound source. Managing tinnitus is notoriously difficult, and access to evidence-based care is limited. Cognitive behavioral therapy (CBT) is a tinnitus management strategy with the most evidence of effectiveness but is rarely offered to those distressed by tinnitus. The provision of internet-based CBT for tinnitus overcomes accessibility barriers; however, it is not currently readily available in the United States. Objective: The aim of this study is to investigate the efficacy of internet-based CBT compared with that of weekly monitoring for the management of tinnitus in reducing tinnitus distress; reducing tinnitus-related comorbidities, including tinnitus cognitions, insomnia, anxiety, and depression; and assessing the stability of the intervention effects 2 months after the intervention. Methods: A 2-arm randomized clinical trial comparing audiologist-guided internet-based CBT (n=79) to a weekly monitoring group (n=79) with a 2-month follow-up assessed the efficacy of internet-based CBT. Eligible participants included adults seeking help for tinnitus. Recruitment was conducted on the web using an open-access website. Participants were randomized via 1:1 allocation, but blinding was not possible. The study was undertaken by English or Spanish speakers on the web. The primary outcome was a change in tinnitus distress as measured using the Tinnitus Functional Index. Secondary outcome measures included anxiety, depression, insomnia, tinnitus cognition, hearing-related difficulties, and quality of life. Results: Internet-based CBT led to a greater reduction in tinnitus distress (mean 36.57, SD 22) compared with that in weekly monitoring (mean 46.31, SD 20.63; effect size: Cohen d=0.46, 95% CI 0.14-0.77) using an intention-to-treat analysis. For the secondary outcomes, there was a greater reduction in negative tinnitus cognition and insomnia. The results remained stable over the 2-month follow-up period. No important adverse events were observed. Further, 16% (10/158) of participants withdrew, with low overall compliance rates for questionnaire completion of 72.3% (107/148) at T1, 61% (91/148) at T2, and 42% (62/148) at T3. Conclusions: This study is the first to evaluate and indicate the efficacy of audiologist-delivered internet-based CBT in reducing tinnitus distress in a US population. It was also the first study to offer internet-based CBT in Spanish to accommodate the large Hispanic population in the United States. The results have been encouraging, and further work is indicated in view of making such an intervention applicable to a wider population. Further work is required to improve compliance and attract more Spanish speakers. Trial Registration: ClinicalTrials.gov NCT04004260; https://clinicaltrials.gov/ct2/show/NCT04004260 %M 35156936 %R 10.2196/27584 %U https://www.jmir.org/2022/2/e27584 %U https://doi.org/10.2196/27584 %U http://www.ncbi.nlm.nih.gov/pubmed/35156936 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 5 %N 1 %P e26008 %T Considerations for a Social Media Physical Activity Program: Exploratory Study %A Scott-Andrews,Katherine Q %A Lane,Annalise %A Rock,Sarah %A Robinson,Leah E %+ School of Kinesiology, University of Michigan, 830 N University Ave, Ann Arbor, MI, 48109, United States, 1 734 647 7645, lerobin@umich.edu %K physical activity %K motor skills %K programs and interventions %K social media %D 2022 %7 14.2.2022 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Social media may be a powerful platform to combat parents’ and children’s low physical activity levels. Objective: This study surveyed parents’ beliefs about physical activity in order to expand the extant literature concerning the interest in and the design of an effective and feasible social media physical activity (SMPA) program. Methods: Primary caregivers (n=250; 215 [86%] mothers, 164 [65.6%] White) of children aged 6-12 years completed an online questionnaire. Interest was examined through responses on the questionnaire; beliefs (ie, perceptions, knowledge, and support) about physical activity were examined using Spearman correlations; and to support the SMPA program design, researchers examined a combination of multiple-choice and free-response questions. For the free-response questions, the researchers performed open coding related to perceived benefits, barriers, and motivators. Results: Parent respondents (n=215, 86%) were interested in a SMPA program tailored for families. Regarding beliefs, parents exhibited a monotonic relationship between 2 questions related to perceptions of physical activity levels in their children (rs(250)=.310, P<.001), knowledge about physical activity and motor skills (rs(250)=.328, P<.001), and support of physical activity and motor skills (rs(250)=.385, P<.001). Parents perceived benefits of a SMPA program, highlighting family time and health. Barriers included time constraints, a lack of motivation, and environmental factors. Conclusions: Parents are interested in supporting healthy family behaviors using a SMPA program. An effective program should emphasize motor skill activities, be fun and family oriented, and incorporate incentives, goal setting, and advice and tips. SMPA also needs to address identified barriers, such as those regarding time and environment. %M 35156926 %R 10.2196/26008 %U https://pediatrics.jmir.org/2022/1/e26008 %U https://doi.org/10.2196/26008 %U http://www.ncbi.nlm.nih.gov/pubmed/35156926 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 2 %P e27500 %T Early Development of a Virtual Coach for Healthy Coping Interventions in Type 2 Diabetes Mellitus: Validation Study %A Bassi,Giulia %A Donadello,Ivan %A Gabrielli,Silvia %A Salcuni,Silvia %A Giuliano,Claudio %A Forti,Stefano %+ Department of Developmental and Socialization Psychology, University of Padova, Via Venezia 8, Padova, 35131, Italy, 39 3477334405, giulia.bassi@phd.unipd.it %K virtual coach %K early development %K type 2 diabetes mellitus %K healthy coping %K Wizard of Oz %K ORBIT model %K pilot study %K mobile phone %D 2022 %7 11.2.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Mobile health solutions aimed at monitoring tasks among people with diabetes mellitus (DM) have been broadly applied. However, virtual coaches (VCs), embedded or not in mobile health, are considered valuable means of improving patients’ health-related quality of life and ensuring adherence to self-care recommendations in diabetes management. Despite the growing need for effective, healthy coping digital interventions to support patients’ self-care and self-management, the design of psychological digital interventions that are acceptable, usable, and engaging for the target users still represents the main challenge, especially from a psychosocial perspective. Objective: This study primarily aims to test VC interventions based on psychoeducational and counseling approaches to support and promote healthy coping behaviors in adults with DM. As a preliminary study, university students have participated in it and have played the standardized patients’ (SPs) role with the aim of improving the quality of the intervention protocol in terms of user acceptability, experience, and engagement. The accuracy of users’ role-playing is further analyzed. Methods: This preliminary study is based on the Obesity-Related Behavioral Intervention Trial model, with a specific focus on its early phases. The healthy coping intervention protocol was initially designed together with a team of psychologists following the main guidelines and recommendations for psychoeducational interventions for healthy coping in the context of DM. The protocol was refined with the support of 3 experts in the design of behavioral intervention technologies for mental health and well-being, who role-played 3 SPs’ profiles receiving the virtual coaching intervention in a Wizard of Oz setting via WhatsApp. A refined version of the healthy coping protocol was then iteratively tested with a sample of 18 university students (mean age 23.61, SD 1.975 years) in a slightly different Wizard of Oz evaluation setting. Participants provided quantitative and qualitative postintervention feedback by reporting their experiences with the VC. Clustering techniques on the logged interactions and dialogs between the VC and users were collected and analyzed to identify additional refinements for future VC development. Results: Both quantitative and qualitative analyses showed that the digital healthy coping intervention was perceived as supportive, motivating, and able to trigger self-reflection on coping strategies. Analyses of the logged dialogs showed that most of the participants accurately played the SPs’ profile assigned, confirming the validity and usefulness of this testing approach in preliminary assessments of behavioral digital interventions and protocols. Conclusions: This study outlined an original approach to the early development and iterative testing of digital healthy coping interventions for type 2 DM. Indeed, the intervention was well-accepted and proved its effectiveness in the definition and refinement of the initial protocol and of the user experience with a VC before directly involving real patients in its subsequent use and testing. %M 35147505 %R 10.2196/27500 %U https://formative.jmir.org/2022/2/e27500 %U https://doi.org/10.2196/27500 %U http://www.ncbi.nlm.nih.gov/pubmed/35147505 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e28233 %T Web-Based Cognitive Testing in Psychiatric Research: Validation and Usability Study %A Lynham,Amy Joanne %A Jones,Ian R %A Walters,James T R %+ Medical Research Council Centre for Neuropsychiatric Genetics and Genomics, Division of Psychiatry and Clinical Neurosciences, School of Medicine, Cardiff University, Cardiff, CF24 4HQ, United Kingdom, 44 29206 88434, waltersjt@cardiff.ac.uk %K cognition %K mental health %K online %K digital %K assessment %K validation %K memory %K attention %K mobile phone %D 2022 %7 10.2.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Cognitive impairments are features of many psychiatric disorders and affect functioning. A barrier to cognitive research on psychiatric disorders is the lack of large cross-disorder data sets. However, the collection of cognitive data can be logistically challenging and expensive. Web-based collection may be an alternative; however, little is known about who does and does not complete web-based cognitive assessments for psychiatric research. Objective: The aims of this study are to develop a web-based cognitive battery for use in psychiatric research, validate the battery against the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery, and compare the characteristics of the participants who chose to take part with those of the individuals who did not participate. Methods: Tasks were developed by The Many Brains Project and selected to measure the domains specified by the MATRICS initiative. We undertook a cross-validation study of 65 participants with schizophrenia, bipolar disorder, depression, or no history of psychiatric disorders to compare the web-based tasks with the MATRICS Consensus Cognitive Battery. Following validation, we invited participants from 2 large ongoing genetic studies, which recruited participants with psychiatric disorders to complete the battery and evaluated the demographic and clinical characteristics of those who took part. Results: Correlations between web-based and MATRICS tasks ranged between 0.26 and 0.73. Of the 961 participants, 887 (92.3%) completed at least one web-based task, and 644 (67%) completed all tasks, indicating adequate completion rates. Predictors of web-based participation included being female (odds ratio [OR] 1.3, 95% CI 1.07-1.58), ethnicity other than White European (OR 0.66, 95% CI 0.46-0.96), higher levels of education (OR 1.19, 95% CI 1.11-1.29), diagnosis of an eating disorder (OR 2.17, 95% CI 1.17-4) or depression and anxiety (OR 5.12, 95% CI 3.38-7.83), and absence of a diagnosis of schizophrenia (OR 0.59, 95% CI 0.35-0.94). Lower performance on the battery was associated with poorer functioning (B=−1.76, SE 0.26; P<.001). Conclusions: Our findings offer valuable insights into the advantages and disadvantages of testing cognitive function remotely for mental health research. %M 35142640 %R 10.2196/28233 %U https://www.jmir.org/2022/2/e28233 %U https://doi.org/10.2196/28233 %U http://www.ncbi.nlm.nih.gov/pubmed/35142640 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 2 %P e30272 %T Effects of a Mindfulness App on Employee Stress in an Australian Public Sector Workforce: Randomized Controlled Trial %A Bartlett,Larissa %A Martin,Angela J %A Kilpatrick,Michelle %A Otahal,Petr %A Sanderson,Kristy %A Neil,Amanda L %+ Wicking Dementia Research and Education Centre, University of Tasmania, 19 Liverpool Street, Hobart, 7000, Australia, 61 409791606, larissa.bartlett@utas.edu.au %K mindfulness %K stress %K apps %K smartphone app %K employee %K workplace %K performance %K mobile phone %D 2022 %7 10.2.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Workplace-based mindfulness programs have good evidence for improving employee stress and mental health outcomes, but less is known about their effects on productivity and citizenship behaviors. Most of the available evidence is derived from studies of mindfulness programs that use class-based approaches. Mindfulness apps can increase access to training, but whether self-directed app use is sufficient to realize benefits equivalent to class-based mindfulness programs is unknown. Objective: We assessed the effectiveness of a mindfulness app, both with and without supporting classes, for reducing employees’ perceived stress. Changes in mindfulness, mental health, quality of life, perceptions of job demand, control and support, productivity indicators, organizational citizenship, and mindful behaviors at work were also investigated. Methods: Tasmanian State Service employees were invited by the Tasmanian Training Consortium to a 3-arm randomized controlled trial investigating the effects of a mindfulness app on stress. The app used in the Smiling Mind Workplace Program formed the basis of the intervention. The app includes lessons, activities, and guided meditations, and is supported by 4 instructional emails delivered over 8 weeks. Engagement with the app for 10-20 minutes, 5 days a week, was recommended. Reported data were collected at baseline (time point 0), 3 months from baseline (time point 1 [T1]), and at 6-month follow-up (time point 2). At time point 0, participants could nominate a work-based observer to answer surveys about participants’ behaviors. Eligible participants (n=211) were randomly assigned to self-guided app use plus four 1-hour classes (app+classes: 70/211, 33.2%), self-guided app use (app-only: 71/211, 33.6%), or waitlist control (WLC; 70/211, 33.2%). Linear mixed effects models were used to assess changes in the active groups compared with the WLC at T1 and for a head-to-head comparison of the app+classes and app-only groups at follow-up. Results: App use time was considerably lower than recommended (app+classes: 120/343 minutes; app-only: 45/343 minutes). Compared with the WLC at T1, no significant change in perceived stress was observed in either active group. However, the app+classes group reported lower psychological distress (β=−1.77, SE 0.75; P=.02; Cohen d=–0.21) and higher mindfulness (β=.31, SE 0.12; P=.01; Cohen d=0.19). These effects were retained in the app+classes group at 6 months. No significant changes were observed for the app-only group or for other outcomes. There were no significant changes in observer measures at T1, but by time point 2, the app+classes participants were more noticeably mindful and altruistic at work than app-only participants. Conclusions: Including classes in the training protocol appears to have motivated engagement and led to benefits, whereas self-guided app use did not realize any significant results. Effect sizes were smaller and less consistent than meta-estimates for class-based mindfulness training. Trial Registration: Australian New Zealand Clinical Trials Register ACTRN12617001386325; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372942&isReview %M 35142630 %R 10.2196/30272 %U https://mhealth.jmir.org/2022/2/e30272 %U https://doi.org/10.2196/30272 %U http://www.ncbi.nlm.nih.gov/pubmed/35142630 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e27735 %T Attrition Within Digital Health Interventions for People With Multiple Sclerosis: Systematic Review and Meta-analysis %A Bevens,William %A Weiland,Tracey %A Gray,Kathleen %A Jelinek,George %A Neate,Sandra %A Simpson-Yap,Steve %+ Centre for Epidemiology and Biostatistics, The University of Melbourne, 207 Bouverie Street, Carlton, 3053, Australia, 61 0498337231, william.bevens@unimelb.edu.au %K digital health %K meta-analysis %K self-management %K eHealth %K attrition %K digital health interventions %K DHI %K multiple sclerosis %K MS %K randomized controlled trials %D 2022 %7 9.2.2022 %9 Review %J J Med Internet Res %G English %X Background: Digital health interventions have revolutionized multiple sclerosis (MS) care by supporting people with MS to better self-manage their disease. It is now understood that the technological elements that comprise this category of digital health interventions can influence participant engagement in self-management programs, and people with MS can experience significant barriers, influenced by these elements, to remaining engaged during a period of learning. It is essential to explore the influence of technological elements in mitigating attrition. Objective: This study aimed to examine the study design and technological elements of documented digital health interventions targeted at people with MS—digital health interventions that were intended to support a program of engagement over a defined period—and to explore how these correlated with attrition among participants of randomized controlled trials (RCTs). Methods: We conducted a systematic review and meta-analysis of RCTs (n=32) describing digital health self-management interventions for people with MS. We analyzed attrition in included studies, using a random-effects model and meta-regression to measure the association between potential moderators. Results: There were no measured differences in attrition between the intervention and control arms; however, some of the heterogeneity observed was explained by the composite technological element score. The pooled attrition rates for the intervention and control arms were 14.7% and 15.6%, respectively. Conclusions: This paper provides insight into the technological composition of digital health interventions designed for people with MS and describes the degree of attrition in both study arms. This paper will aid in the design of future studies in this area, particularly for digital health interventions of this type. %M 35138262 %R 10.2196/27735 %U https://www.jmir.org/2022/2/e27735 %U https://doi.org/10.2196/27735 %U http://www.ncbi.nlm.nih.gov/pubmed/35138262 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e28747 %T Effectiveness of Unguided Internet-Based Cognitive Behavioral Therapy and the Three Good Things Exercise for Insomnia: 3-Arm Randomized Controlled Trial %A Sato,Daisuke %A Sekizawa,Yoichi %A Sutoh,Chihiro %A Hirano,Yoshiyuki %A Okawa,Sho %A Hirose,Motohisa %A Takemura,Ryo %A Shimizu,Eiji %+ Department of Cognitive Behavioral Physiology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670, Japan, 81 043 226 2027, daisuke-sato@umin.ac.jp %K insomnia %K internet-based treatment %K cognitive behavioral therapy %K positive psychology %K randomized controlled trial %K mobile phone %D 2022 %7 9.2.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The treatment of insomnia with sleep medication causes problems such as long-term use, dependence, and significant economic losses, including medical expenses. Evidence-based lifestyle guidance is required to improve insomnia symptoms not only in person but also in easy-to-use web-based formats. Objective: This study aims to clarify whether unguided internet-based cognitive behavioral therapy (ICBT) or the Three Good Things (TGT) exercise, both administered as self-help internet interventions without email support, could improve insomnia symptoms compared with a waiting list control (WLC) group. Methods: A 4-week program was implemented, and participants were randomly allocated to 1 of the 3 groups. The primary outcome measure was the Pittsburgh Sleep Questionnaire (PSQI) score at 4 weeks compared with baseline. Results: Of the 21,394 individuals invited to participate, 312 (1.46%) met the eligibility criteria and were randomly assigned to 1 of the 3 groups. Of these 312 individuals, 270 (86.5%; ICBT 79/270, 29.3%; TGT 88/270, 32.6%; and WLC 103/270, 38.1%) completed a postintervention survey at 4 and 8 weeks. The adjusted mean changes of the primary outcome measure (PSQI) in the ICBT (−1.56, 95% CI −2.52 to −0.59; P<.001) and TGT (−1.15, 95% CI −2.08 to −0.23; P=.002) groups at 4 weeks from baseline showed a significant improvement compared with the WLC group. The adjusted mean changes in the secondary outcome measures of sleep onset latency, total sleep time, Athens Insomnia Scale score, and Patient Health Questionnaire-9 score at 4 weeks from baseline, as well as in the PSQI at 8 weeks from baseline, showed significant improvement for ICBT. Moreover, total sleep time, Athens Insomnia Scale, and Patient Health Questionnaire-9 scores at 4 weeks from baseline showed a significant improvement in the TGT group compared with the WLC group. Conclusions: A total of 4 weeks of unguided ICBT and TGT exercises improved insomnia. Trial Registration: University Hospital Medical Information Network Clinical Trial Registry UMIN000034927; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039814 %M 35138259 %R 10.2196/28747 %U https://www.jmir.org/2022/2/e28747 %U https://doi.org/10.2196/28747 %U http://www.ncbi.nlm.nih.gov/pubmed/35138259 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 2 %P e31018 %T Web-Based Interventions to Help Australian Adults Address Depression, Anxiety, Suicidal Ideation, and General Mental Well-being: Scoping Review %A Skaczkowski,Gemma %A van der Kruk,Shannen %A Loxton,Sophie %A Hughes-Barton,Donna %A Howell,Cate %A Turnbull,Deborah %A Jensen,Neil %A Smout,Matthew %A Gunn,Kate %+ Department of Rural Health, Allied Health and Human Performance, University of South Australia, North Terrace, Adelaide, 5001, Australia, 61 417852537, kate.gunn@unisa.edu.au %K web-based interventions %K depression %K anxiety %K suicide %K well-being %K mental health %K technology %K access to health care %D 2022 %7 8.2.2022 %9 Review %J JMIR Ment Health %G English %X Background: A large number of Australians experience mental health challenges at some point in their lives. However, in many parts of Australia, the wait times to see general practitioners and mental health professionals can be lengthy. With increasing internet use across Australia, web-based interventions may help increase access to timely mental health care. As a result, this is an area of increasing research interest, and the number of publicly available web-based interventions is growing. However, it can be confusing for clinicians and consumers to know the resources that are evidence-based and best meet their needs. Objective: This study aims to scope out the range of web-based mental health interventions that address depression, anxiety, suicidal ideation, or general mental well-being and are freely available to Australian adults, along with their impact, acceptability, therapeutic approach, and key features. Methods: The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for scoping reviews (PRISMA-ScR [PRISMA extension for Scoping Reviews]) guided the review process. Keywords for the search were depression, anxiety, suicide, and well-being. The search was conducted using Google as well as the key intervention databases Beacon, Head to Health, and e-Mental Health in Practice. Interventions were deemed eligible if they targeted depression, anxiety, suicidal ideation, or general mental well-being (eg, resilience) in adults; and were web-based, written in English, interactive, free, and publicly available. They also had to be guided by an evidence-based therapeutic approach. Results: Overall, 52 eligible programs were identified, of which 9 (17%) addressed depression, 15 (29%) addressed anxiety, 13 (25%) addressed general mental well-being, and 13 (25%) addressed multiple issues. Only 4% (2/52) addressed distress in the form of suicidal ideation. The most common therapeutic approach was cognitive behavioral therapy. Half of the programs guided users through exercises in a set sequence, and most programs enabled users to log in and complete the activities on their own without professional support. Just over half of the programs had been evaluated for their effectiveness in reducing symptoms, and 11% (6/52) were being evaluated at the time of writing. Program evaluation scores ranged from 44% to 100%, with a total average score of 85%. Conclusions: There are numerous web-based programs for depression, anxiety, suicidal ideation, and general well-being, which are freely and publicly available in Australia. However, identified gaps include a lack of available web-based interventions for culturally and linguistically diverse populations and programs that use newer therapeutic approaches such as acceptance and commitment therapy and dialectical behavior therapy. Despite most programs included in this review being of good quality, clinicians and consumers should pay careful attention when selecting which program to recommend and use, as variations in the levels of acceptability and impact of publicly available programs do exist. %M 35133281 %R 10.2196/31018 %U https://mental.jmir.org/2022/2/e31018 %U https://doi.org/10.2196/31018 %U http://www.ncbi.nlm.nih.gov/pubmed/35133281 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 2 %P e27642 %T Therapist-Assisted Web-Based Intervention for Prolonged Grief Disorder After Cancer Bereavement: Randomized Controlled Trial %A Kaiser,Julia %A Nagl,Michaela %A Hoffmann,Rahel %A Linde,Katja %A Kersting,Anette %+ Department of Psychosomatic Medicine and Psychotherapy, University of Leipzig, Semmelweisstraße 10, Leipzig, 04103, Germany, 49 34197 ext 18943, julia.kaiser@medizin.uni-leipzig.de %K digital interventions %K grief %K traumatic loss %K treatment effectiveness evaluation %K cognitive behavioral therapy %K neoplasms %D 2022 %7 8.2.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Bereavement due to cancer increases the risk of prolonged grief disorder. However, specialized treatment options for prolonged grief after a loss due to illness are still scarce. Objective: The aim of this study is to extend previous findings by evaluating a web-based cognitive behavioral intervention with asynchronous therapist support, consisting of structured writing tasks adapted specifically for prolonged grief after cancer bereavement. Methods: The intervention was evaluated in a purely web-based randomized waitlist-controlled trial. Open-access recruitment of participants was conducted on the web. Prolonged grief (Inventory of Complicated Grief), depression, anxiety, posttraumatic stress, posttraumatic growth, somatization, sleep quality, and mental and physical health were assessed on the web via validated self-report measures. Results: A total of 87 participants were randomized into the intervention group (IG; 44/87, 51%) or the waitlist control group (43/87, 49%). Of the participants, 7% (6/87) dropped out of the study (5/44, 11%, in the IG). Of the 39 completers in the IG, 37 (95%) completed all intervention tasks. The intervention reduced symptoms of prolonged grief (intention-to-treat: P<.001; η2=0.34; Cohen d=0.80) to a clinically significant extent. It had favorable effects on depression, anxiety, posttraumatic stress, posttraumatic growth, and overall mental health but not on somatization, sleep quality, or physical health. Conclusions: The web-based intervention for prolonged grief after cancer bereavement is effective in reducing symptoms of prolonged grief disorder and accompanying syndromes in a timely, easily realizable manner and addresses specific challenges of bereavement to illness. Considering web-based approaches in future mental health care policy and practice can reduce health care gaps for those who are bereaved to cancer. Trial Registration: German Clinical Trial Register U1111–1186-6255; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00011001 %M 35133286 %R 10.2196/27642 %U https://mental.jmir.org/2022/2/e27642 %U https://doi.org/10.2196/27642 %U http://www.ncbi.nlm.nih.gov/pubmed/35133286 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 2 %P e29393 %T Home-Based Spirometry Telemonitoring After Allogeneic Hematopoietic Cell Transplantation: Mixed Methods Evaluation of Acceptability and Usability %A Sheshadri,Ajay %A Makhnoon,Sukh %A Alousi,Amin M %A Bashoura,Lara %A Andrade,Rene %A Miller,Christopher J %A Stolar,Karen R %A Arain,Muhammad Hasan %A Noor,Laila %A Balagani,Amulya %A Jain,Akash %A Blanco,David %A Ortiz,Abel %A Taylor,Michael S %A Stenzler,Alex %A Mehta,Rohtesh %A Popat,Uday R %A Hosing,Chitra %A Ost,David E %A Champlin,Richard E %A Dickey,Burton F %A Peterson,Susan K %+ Department of Pulmonary Medicine, The University of Texas MD Anderson Cancer Center, 1400 Pressler Unit 1462, Houston, TX, 77030, United States, 1 7135631987, asheshadri@mdanderson.org %K allogeneic hematopoietic cell transplantation %K home-based spirometry %K acceptability %K usability %K mixed methods evaluation %K patient perspectives %K spirometry %K feasibility %K mHealth %K home-based %K remote care %K respirology %K pulmonary medicine %K mobile phone %D 2022 %7 7.2.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Home-based spirometry (HS) allows for the early detection of lung complications in recipients of an allogeneic hematopoietic cell transplant (AHCT). Although the usability and acceptability of HS are critical for adherence, patient-reported outcomes of HS use remain poorly understood in this setting. Objective: The aim of this study is to design a longitudinal, mixed methods study to understand the usability and acceptability of HS among recipients of AHCT. Methods: Study participants performed HS using a Bluetooth-capable spirometer that transmitted spirometry data to the study team in real time. In addition, participants completed usability questionnaires and in-depth interviews and reported their experiences with HS. Analysis of interview data was guided by the constructs of performance expectancy, effort expectancy, and social influence from the Unified Theory of Acceptance and Use of Technology model. Results: Recipients of AHCT found HS to be highly acceptable despite modest technological barriers. On average, participants believed that the HS was helpful in managing symptoms related to AHCT (scores ranging from 2.22 to 2.68 on a scale of 0-4) and for early detection of health-related problems (score range: 2.88-3.12). Participants viewed HS favorably and were generally supportive of continued use. No significant barriers to implementation were identified from the patient’s perspective. Age and gender were not associated with the patient perception of HS. Conclusions: Study participants found HS acceptable and easy to use. Some modifiable technical barriers to performing HS were identified; however, wider implementation of pulmonary screening is feasible from the patient’s perspective. %M 35129455 %R 10.2196/29393 %U https://formative.jmir.org/2022/2/e29393 %U https://doi.org/10.2196/29393 %U http://www.ncbi.nlm.nih.gov/pubmed/35129455 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 8 %N 2 %P e25890 %T Effectiveness of Mobile Phone and Web-Based Interventions for Diabetes and Obesity Among African American and Hispanic Adults in the United States: Systematic Review %A Enyioha,Chineme %A Hall,Matthew %A Voisin,Christiane %A Jonas,Daniel %+ Department of Family Medicine, University of North Carolina at Chapel Hill, 590 Manning Drive, Chapel Hill, NC, 27514, United States, 1 9849744888, chineme_enyioha@med.unc.edu %K mHealth %K mobile health %K technology %K diabetes %K obesity %K African American %K Hispanic %D 2022 %7 4.2.2022 %9 Review %J JMIR Public Health Surveill %G English %X Background: Mobile health (mHealth) and web-based technological advances allow for new approaches to deliver behavioral interventions for chronic diseases such as obesity and diabetes. African American and Hispanic adults experience a disproportionate burden of major chronic diseases. Objective: This paper reviews the evidence for mHealth and web-based interventions for diabetes and obesity in African American and Hispanic adults. Methods: Literature searches of PubMed/Medline, The Cochrane Library, EMBASE, CINAHL Plus, Global Health, Scopus, and Library & Information Science Source were conducted for relevant English-language articles. Articles identified through searches were reviewed by 2 investigators and, if they met the inclusion criteria, were extracted and assessed for risk of bias. Findings were summarized in tabular and narrative format. The overall strength of the evidence was assessed as high, moderate, low, or insufficient on the basis of risk of bias, consistency of findings, directness, precision, and other limitations. Results: Searches yielded 2358 electronic publications, 196 reports were found to be eligible for inclusion, and 7 studies met the eligibility criteria. All 7 included studies were randomized control trials. Five studies evaluated the effectiveness of an mHealth intervention for weight loss, including one that evaluated the effectiveness for diabetes and two studies focused on diabetes. Of all the studies that focused on weight loss, 3 reported significant differences in weight loss in participants in the intervention group compared with those in the usual care group. Although all studies on diabetes control showed greater improvement in glycemic control for the intervention group compared to that in the control group, only one study showed a significant difference between the 2 groups. Conclusions: This analysis indicates that there are few published studies that assessed mHealth interventions among minority populations and focused on weight or diabetes. Although the overall strength of evidence was low for diabetes control, it was moderate for weight loss, and our findings suggest that mHealth and web-based interventions may provide a promising approach for interventions among African American and Hispanic adults who have obesity or diabetes. %M 35119368 %R 10.2196/25890 %U https://publichealth.jmir.org/2022/2/e25890 %U https://doi.org/10.2196/25890 %U http://www.ncbi.nlm.nih.gov/pubmed/35119368 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 2 %P e29537 %T Preferences for Technology-Mediated Behavioral Lifestyle Interventions With Different Levels of Coach and Peer Support Among Latino Men: Comparative Study Within One Arm of a Randomized Controlled Trial %A Rosas,Lisa G %A Lv,Nan %A Xiao,Lan %A Azar,Kristen MJ %A Hooker,Steven P %A Venditti,Elizabeth M %A Lewis,Megan A %A Zavella,Patricia %A Ma,Jun %+ Department of Epidemiology and Population Health, Stanford University, 1701 Page Mill Rd., 2nd Floor, Palo Alto, CA, 94304, United States, 1 6505759519, lgrosas@stanford.edu %K Latino men’s health %K technology-mediated behavioral interventions %K weight management %K mobile phone %D 2022 %7 4.2.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Although Latino men have the highest prevalence (45%) of obesity among all men in the United States, traditional weight loss interventions have not effectively engaged this hard-to-reach and diverse group. Offering choices among technology-mediated weight loss interventions may offer advantages. Objective: The aim of this study is to examine Latino men’s preferences among 3 weight loss intervention options. We also examined whether attendance in group sessions (videoconference and in person) and weight loss differed according to intervention choice. Methods: Latino men (n=200; mean age 47.3, SD 11.8 years) participated in a comparative effectiveness trial based on primary care and were randomized to receive the 1-year HOMBRE (Hombres con Opciones para Mejorar su Bienestar para Reducir Enfermedades Crónicas; English translation: Men With Options to Improve Their Well-being and Reduce Chronic Disease) intervention. HOMBRE is a weight loss intervention that offers 3 delivery options. During an orientation session, a trained bilingual coach helped men select 1 of the 3 intervention options that differed in coach, peer support, and available language. We used canonical discriminant analysis to assess multivariate associations of demographic, clinical, employment, cultural, and technology use and access factors with men’s intervention choices. We used generalized linear models to estimate weight loss at 6, 12, and 18 months for men in each intervention option. Results: Among Latino men, 28% (56/200) chose videoconference groups, 31% (62/200) chose web-based videos, and 41% (82/200) chose in-person groups. The canonical discriminant analysis identified 1 orthogonal dimension that distinguished between men who chose an in-person group and men who chose web-based videos. Men who were older, spoke Spanish, and did not use a computer frequently had a higher probability of choosing in-person groups versus web-based videos. For men who selected a group delivery option, 86.9% (107/123) attended ≥25% of the sessions, 83.7% (103/123) attended ≥50% of the sessions, and 73.2% (90/123) attended ≥75% of the sessions, with no differences by type of group (videoconference or in person). Men who chose videoconference and in-person group sessions lost significantly more weight at 6 months (both P<.001) and 18 months (P=.02 and P=.04, respectively) than those who chose web-based videos. Men who chose in-person group sessions also lost significantly more weight at 12 months (P=.008) than those who chose web-based videos. Conclusions: There were significant differences according to demographic, employment, cultural, and technology use factors between men who chose 1 of the 3 intervention options. Men who chose one of the group-based options (videoconference or in person) lost significantly more weight than those who chose web-based videos. Providing options that accommodate the diversity of Latino men’s preferences is important for increasing engagement in behavioral interventions. Trial Registration: ClinicalTrials.gov NCT03092960; https://clinicaltrials.gov/ct2/show/NCT03092960 %M 35119377 %R 10.2196/29537 %U https://formative.jmir.org/2022/2/e29537 %U https://doi.org/10.2196/29537 %U http://www.ncbi.nlm.nih.gov/pubmed/35119377 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e30880 %T The Effect of Adjunct Telephone Support on Adherence and Outcomes of the Reboot Online Pain Management Program: Randomized Controlled Trial %A Gardner,Tania %A Schultz,Regina %A Haskelberg,Hila %A Newby,Jill M %A Wheatley,Jane %A Millard,Michael %A Faux,Steven G %A Shiner,Christine T %+ Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, 406 Victoria St, Sydney, 2010, Australia, 61 0410449766, taniagardner@optusnet.com.au %K chronic pain %K online pain management %K telephone support %K clinician guidance %K adherence %K digital health %K eHealth %K internet interventions %K multidisciplinary %D 2022 %7 3.2.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-based treatment programs present a solution for providing access to pain management for those unable to access clinic-based multidisciplinary pain programs. Attrition from internet interventions is a common issue. Clinician-supported guidance can be an important feature in web-based interventions; however, the optimal level of therapist guidance and expertise required to improve adherence remains unclear. Objective: The aim of this study is to evaluate whether augmenting the existing Reboot Online program with telephone support by a clinician improves program adherence and effectiveness compared with the web-based program alone. Methods: A 2-armed, CONSORT (Consolidated Standards of Reporting Trials)–compliant, registered randomized controlled trial with one-to-one group allocation was conducted. It compared a web-based multidisciplinary pain management program, Reboot Online, combined with telephone support (n=44) with Reboot Online alone (n=45) as the control group. Participants were recruited through web-based social media and the This Way Up service provider network. The primary outcome for this study was adherence to the Reboot Online program. Adherence was quantified through three metrics: completion of the program, the number of participants who enrolled into the program, and the number of participants who commenced the program. Data on adherence were collected automatically through the This Way Up platform. Secondary measures of clinical effectiveness were also collected. Results: Reboot Online combined with telephone support had a positive effect on enrollment and commencement of the program compared with Reboot Online without telephone support. Significantly more participants from the Reboot Online plus telephone support group enrolled (41/44, 93%) into the course than those from the control group (35/45, 78%; χ21=4.2; P=.04). Furthermore, more participants from the intervention group commenced the course than those from the control group (40/44, 91% vs 27/45, 60%, respectively; χ21=11.4; P=.001). Of the participants enrolled in the intervention group, 43% (19/44) completed the course, and of those in the control group, 31% (14/45) completed the course. When considering the subgroup of those who commenced the program, there was no significant difference between the proportions of people who completed all 8 lessons in the intervention (19/40, 48%) and control groups (14/27, 52%; χ21=1.3; P=.24). The treatment efficacy on clinical outcome measures did not differ between the intervention and control groups. Conclusions: Telephone support improves participants’ registration, program commencement, and engagement in the early phase of the internet intervention; however, it did not seem to have an impact on overall course completion or efficacy. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619001076167; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619001076167 %M 35113021 %R 10.2196/30880 %U https://www.jmir.org/2022/2/e30880 %U https://doi.org/10.2196/30880 %U http://www.ncbi.nlm.nih.gov/pubmed/35113021 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 2 %P e30295 %T Use of a Smartphone App Versus Motivational Interviewing to Increase Walking Distance and Weight Loss in Overweight/Obese Adults With Peripheral Artery Disease: Pilot Randomized Trial %A Collins,Tracie %A Geana,Mugur %A Overton,Kathryn %A Benton,Mary %A Lu,Liuqiang %A Khan,Faarina %A Rohleder,Mason %A Ahluwalia,Jasjit %A Resnicow,Ken %A Zhu,Yiliang %+ College of Population Health, University of New Mexico, MSC09 5070, 1 University of New Mexico, Albuquerque, NM, 87131-0001, United States, 1 505 272 4979, tccollins@salud.unm.edu %K mobile health %K smartphone app %K peripheral artery disease %K motivational interviewing %D 2022 %7 3.2.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Walking therapy improves functional outcomes in patients with peripheral artery disease (PAD). Less is known about the additive benefit of a dietary intervention. Objective: Our objectives were to develop a smartphone app and, as a pilot, explore its potential efficacy as compared to motivational interviewing (MI) to increase walking distance and promote weight loss in overweight/obese adults with PAD. Methods: We conducted a 3-month, 2-arm randomized pilot study at the University of Kansas. Inclusion criteria were BMI >27 kg/m2 and symptomatic PAD, defined by an ankle-brachial index <0.9. Patients were randomized into 2 groups: MI, delivered through in-person and telephone counseling, and app, a mobile smartphone app. Both interventions encouraged walking for exercise and healthy dietary habits (increasing fruits and vegetables and whole grains while reducing fat and sugary drinks). We assessed medical history at baseline. At baseline and 3 months, participants completed an assessment of 6-minute walking distance, weight, quality of life, exercise behaviors, and dietary habits. The primary outcome was 3-month change in walking distance. Secondary outcomes were changes in weight, quality of life, exercise behaviors, and dietary habits. We used a Wilcoxon rank-sum test to analyze the primary and secondary outcomes at 3 months within the MI and app groups and to compare the changes between the groups with adjustment for baseline. Results: We randomized 29 participants with a mean age of 66.03 (SD 8.12) years; 25 participants completed the trial. At baseline, mean walking distance among completers was 260.40 (SD 94.32) meters and 326.15 (SD 69.28) meters for MI and app participants, respectively. At 3 months, the mean walking distance was 298.67 (SD 101.20) meters and 331.19 (SD 58.63) meters for MI and app participants, respectively (group difference P=.03, adjusting for baseline). Increase in walking distance at 3 months was 40.5 meters (95% CI 6.77 to 61.34; P=.02) in MI group. At baseline, mean body weight was 253.10 (SD 59.45) lbs and 225.13 (SD 58.93) lbs for MI and app participants, respectively. At 3 months, mean body weight was 242.14 (SD 58.54) lbs and 223.44 (SD 59.54) lbs for MI and app, respectively (group difference P=.006, adjusting for baseline). Pre-post study decrease in weight was 10.1 lbs (95% CI –17.9 to –3.0) and 2.3 lbs (95% CI –3.4 to –0.7) in MI and app group, respectively. Comparing baseline to 3 months, there were no statistically significant differences in quality of life, exercise behaviors, or dietary habits. Conclusions: Our study demonstrates that MI can promote walking and weight loss in overweight/obese adults with PAD. The smartphone app showed a small weight loss but no statistically significant increase in walking distance. As this was a pilot study, future large-scale studies are needed to replicate the efficacy of MI to promote weight loss in overweight or obese adults with PAD. Trial Registration: ClinicalTrials.gov NCT03694652; https://clinicaltrials.gov/ct2/show/NCT03694652 %M 35113020 %R 10.2196/30295 %U https://formative.jmir.org/2022/2/e30295 %U https://doi.org/10.2196/30295 %U http://www.ncbi.nlm.nih.gov/pubmed/35113020 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 2 %P e27794 %T The Effects of mHealth-Based Gamification Interventions on Participation in Physical Activity: Systematic Review %A Xu,Linqi %A Shi,Hongyu %A Shen,Meidi %A Ni,Yuanyuan %A Zhang,Xin %A Pang,Yue %A Yu,Tianzhuo %A Lian,Xiaoqian %A Yu,Tianyue %A Yang,Xige %A Li,Feng %+ School of Nursing, Jilin University, 965 Xinjiang Street, Changchun, 130012, China, 86 1 779 008 9009, fli@jlu.edu.cn %K mobile health %K gamification %K physical activity %K systematic review %K mobile phone %D 2022 %7 3.2.2022 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: It is well known that regular physical exercise has associated benefits; yet, participation remains suboptimal. Mobile health (mHealth) has become an indispensable medium to deliver behavior change interventions, and there is a growing interest in the gamification apps in mHealth to promote physical activity (PA) participation. Gamification could use game design elements (such as points, leaderboards, and progress bars), and it has the potential to increase motivation for PA and engagement. However, mHealth-based gamification interventions are still emerging, and little is known about the application status and efficacy of such interventions. Objective: This systematic review aims to investigate gamification apps in mHealth for improving PA levels and simultaneously summarize the impact of gamification interventions on PA participation. Methods: We searched PubMed, Scopus, Web of Science, Embase, CINAHL (EBSCO host), and IEEE Xplore from inception to December 20, 2020. Original empirical research exploring the effects of gamification interventions on PA participation was included. The papers described at least one outcome regarding exercise or PA participation, which could be subjective self-report or objective indicator measurement. Of note, we excluded studies about serious games or full-fledged games. Results: Of 2944 studies identified from the database search, 50 (1.69%) were included, and the information was synthesized. The review revealed that gamification of PA had been applied to various population groups and broadly distributed among young people but less distributed among older adults and patients with a disease. Most of the studies (30/50, 60%) combined gamification with wearable devices to improve PA behavior change, and 50% (25/50) of the studies used theories or principles for designing gamified PA interventions. The most frequently used game elements were goal-setting, followed by progress bars, rewards, points, and feedback. This review demonstrated that gamification interventions could increase PA participation; however, the results were mixed, and modest changes were attained, which could be attributed to the heterogeneity across studies. Conclusions: Overall, this study provides an overview of the existing empirical research in PA gamification interventions and provides evidence for the efficacy of gamification in enhancing PA participation. High-quality empirical studies are needed in the future to assess the efficacy of a combination of gamification and wearable activity devices to promote PA, and further exploration is needed to investigate the optimal implementation of these features of game elements and theories to enhance PA participation. %M 35113034 %R 10.2196/27794 %U https://mhealth.jmir.org/2022/2/e27794 %U https://doi.org/10.2196/27794 %U http://www.ncbi.nlm.nih.gov/pubmed/35113034 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 2 %P e30811 %T Interactive Mobile Phone HIV Adherence Support for Men Who Have Sex With Men in the Philippines Connect for Life Study: Mixed Methods Approach to Intervention Development and Pilot Testing %A O'Connor,Cara %A Leyritana,Katerina %A Doyle,Aoife M %A Lewis,James J %A Gill,Randeep %A Salvaña,Edsel Maurice %+ Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, United Kingdom, 44 791336248, caraoc@gmail.com %K mHealth %K adherence %K HIV %K antiretroviral therapy %K intervention development %K mobile phone %D 2022 %7 3.2.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The HIV epidemic in the Philippines is one of the fastest growing epidemics globally, and infections among men who have sex with men are rising at an alarming rate. The World Health Organization recommends the use of mobile health (mHealth) technologies to engage patients in care and ensure high levels of adherence to antiretroviral therapy (ART). Existing mHealth interventions can be adapted and tailored to the context and population served. Objective: This study aims to create a locally tailored intervention using a mobile phone platform to support treatment adherence for HIV patients on ART in the Philippines. Methods: A mixed methods approach guided by the Behavior Change Wheel framework was used to adapt an existing mHealth adherence support platform for the local setting and target population. A literature review, retrospective clinical record review, and focus group discussions with patients were conducted to understand the drivers of ART adherence and tailor the intervention accordingly. The resulting intervention was pilot-tested for 8 weeks, followed by focus group discussions with patients who received the intervention to assess the acceptability of the design. Results: Key issues contributing to nonadherence included side effects, lack of behavioral skills for pill taking, social support, mental health, and substance use. Patients identified mHealth as an acceptable mode of intervention delivery and wanted mHealth services to be highly personalizable. The study team, clinicians, and software developers integrated these findings into the intervention, which included a menu of services as follows: pill reminders, health tips, adherence feedback, appointment reminders, and symptom reporting. During the pilot phase, technical issues in the interactive voice response system (IVRS) were identified and addressed. Patients who participated in the pilot phase expressed a preference for SMS text messaging over the IVRS. Patients responded positively to the appointment reminders and health tips, whereas patient feedback on daily and weekly pill reminders and adherence feedback was mixed. Conclusions: The mobile phone–based SMS text messaging and IVRS intervention was acceptable to men who have sex with men in Manila, the Philippines, and qualitative analysis suggested that the intervention helped promote ART adherence and appointment attendance. %M 35113030 %R 10.2196/30811 %U https://formative.jmir.org/2022/2/e30811 %U https://doi.org/10.2196/30811 %U http://www.ncbi.nlm.nih.gov/pubmed/35113030 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e30457 %T Effectiveness of eHealth and mHealth Interventions Supporting Children and Young People Living With Juvenile Idiopathic Arthritis: Systematic Review and Meta-analysis %A Butler,Sonia %A Sculley,Dean %A Santos,Derek %A Fellas,Antoni %A Gironès,Xavier %A Singh-Grewal,Davinder %A Coda,Andrea %+ School of Bioscience and Pharmacy, College of Health, Medicine and Wellbeing, University of Newcastle, 10 Chittaway Rd, Ourimbah, 2258, Australia, 61 421945914, sonia.butler@newcastle.edu.au %K eHealth %K mobile health %K mHealth %K juvenile idiopathic arthritis %K pediatric %K effectiveness %K pain %K physical activity %K health-related quality of life %K self-management %K education %K mobile phone %D 2022 %7 2.2.2022 %9 Review %J J Med Internet Res %G English %X Background: Juvenile idiopathic arthritis (JIA) management aims to promote remission through timely, individualized, well-coordinated interdisciplinary care using a range of pharmacological, physical, psychological, and educational interventions. However, achieving this goal is workforce-intensive. Harnessing the burgeoning eHealth and mobile health (mHealth) interventions could be a resource-efficient way of supplementing JIA management. Objective: This systematic review aims to identify the eHealth and mHealth interventions that have been proven to be effective in supporting health outcomes for children and young people (aged 1-18 years) living with JIA. Methods: We systematically searched 15 databases (2018-2021). Studies were eligible if they considered children and young people (aged 1-18 years) diagnosed with JIA, an eHealth or mHealth intervention, any comparator, and health outcomes related to the used interventions. Independently, 2 reviewers screened the studies for inclusion and appraised the study quality using the Downs and Black (modified) checklist. Study outcomes were summarized using a narrative, descriptive method and, where possible, combined for a meta-analysis using a random-effects model. Results: Of the 301 studies identified in the search strategy, 15 (5%) fair-to-good–quality studies met the inclusion criteria, which identified 10 interventions for JIA (age 4-18.6 years). Of these 10 interventions, 5 (50%) supported symptom monitoring by capturing real-time data using health applications, electronic diaries, or web-based portals to monitor pain or health-related quality of life (HRQoL). Within individual studies, a preference was demonstrated for real-time pain monitoring over recall pain assessments because of a peak-end effect, improved time efficiency (P=.002), and meeting children’s and young people’s HRQoL needs (P<.001) during pediatric rheumatology consultations. Furthermore, 20% (2/10) of interventions supported physical activity promotion using a web-based program or a wearable activity tracker. The web-based program exhibited a moderate effect, which increased endurance time, physical activity levels, and moderate to vigorous physical activity (standardized mean difference [SMD] 0.60, SD 0.02-1.18; I2=79%; P=.04). The final 30% (3/10) of interventions supported self-management development through web-based programs, or apps, facilitating a small effect, reducing pain intensity (SMD −0.14, 95% CI −0.43 to 0.15; I2=53%; P=.33), and increasing disease knowledge and self-efficacy (SMD 0.30, 95% CI 0.03-0.56; I2=74%; P=.03). These results were not statistically significant. No effect was seen regarding pain interference, HRQoL, anxiety, depression, pain coping, disease activity, functional ability, or treatment adherence. Conclusions: Evidence that supports the inclusion of eHealth and mHealth interventions in JIA management is increasing. However, this evidence needs to be considered cautiously because of the small sample size, wide CIs, and moderate to high statistical heterogeneity. More rigorous research is needed on the longitudinal effects of real-time monitoring, web-based pediatric rheumatologist–children and young people interactions, the comparison among different self-management programs, and the use of wearable technologies as an objective measurement for monitoring physical activity before any recommendations that inform current practice can be given. %M 35107431 %R 10.2196/30457 %U https://www.jmir.org/2022/2/e30457 %U https://doi.org/10.2196/30457 %U http://www.ncbi.nlm.nih.gov/pubmed/35107431 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e31565 %T Real-world Implementation of a Smartphone-Based Psychoeducation Program for Bipolar Disorder: Observational Ecological Study %A García-Estela,Aitana %A Cantillo,Jordi %A Angarita-Osorio,Natalia %A Mur-Milà,Estanislao %A Anmella,Gerard %A Pérez,Víctor %A Vieta,Eduard %A Hidalgo-Mazzei,Diego %A Colom,Francesc %+ Mental Health Research Group, Hospital del Mar Medical Research Institute (IMIM), Office 202, PRBB Building, Doctor Aiguader, 88, Barcelona, 08003, Spain, 34 933160400 ext 1493, fcolom@imim.es %K bipolar disorder %K psychoeducation %K smartphone %K app %K SIMPLe %K Intervention %K mobile phone %D 2022 %7 2.2.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: SIMPLe is an internet‐delivered self‐management mobile app for bipolar disorder (BD) designed to combine technology with evidence-based interventions and facilitate access to psychoeducational content. The SIMPLe app was launched to the real world to make it available worldwide within the context of BD treatment. Objective: The main aims of this study are as follows: to describe app use, engagement, and retention rates based on server data; to identify patterns of user retention over the first 6-month follow-up of use; and to explore potential factors contributing to discontinuation of app use. Methods: This was an observational ecological study in which we pooled available data from a real-world implementation of the SIMPLe app. Participation was open on the project website, and the data-collection sources were a web-based questionnaire on clinical data and treatment history administered at inclusion and at 6 months, subjective data gathered through continuous app use, and the use patterns captured by the app server. Characteristics and engagement of regular users, occasional users, and no users were compared using 2-tailed t tests or analysis of variance or their nonparametric equivalent. Survival analysis and risk functions were applied to regular users’ data to examine and compare use and user retention. In addition, a user evaluation analysis was performed based on satisfaction, perceived usefulness, and reasons to discontinue app use. Results: We included 503 participants with data collected between 2016 and 2018, of whom 77.5% (n=390) used the app. Among the app users, 44.4% (173/390) completed the follow-up assessment, and data from these participants were used in our analyses. Engagement declined gradually over the first 6 months of use. The probability of retention of the regular users after 1 month of app use was 67.4% (263/390; 95% CI 62.7%-72.4%). Age (P=.002), time passed since illness onset (P<.001), and years since diagnosis of BD (P=.048) correlate with retention duration. In addition, participants who had been diagnosed with BD for longer used the app on more days (mean 97.73, SD 69.15 days; P=.002) than those who had had a more recent onset (mean 66.49, SD 66.18 days; P=.002) or those who had been diagnosed more recently (mean 73.45, SD 66 days; P=.01). Conclusions: The user retention rate of the app decreased rapidly after each month until reaching only one-third of the users at 6 months. There exists a strong association between age and app engagement of individuals with BD. Other variables such as years lived with BD, diagnosis of an anxiety disorder, and taking antipsychotics seem relevant as well. Understanding these associations can help in the definition of the most suitable user profiles for predicting trends of engagement, optimization of app prescription, and management. %M 35107440 %R 10.2196/31565 %U https://www.jmir.org/2022/2/e31565 %U https://doi.org/10.2196/31565 %U http://www.ncbi.nlm.nih.gov/pubmed/35107440 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e27781 %T Perceived Acceptability and Experiences of a Digital Psychoeducation and Peer Support Intervention (COPe-support): Interview Study With Carers Supporting Individuals With Psychosis %A Batchelor,Rachel %A Gulshan,Sarah %A Shritharan,Halpana %A Williams,Elen %A Henderson,Claire %A Gillard,Steve %A Woodham,Luke A %A Cornelius,Victoria %A Elkes,Jack %A Sin,Jacqueline %+ School of Health Sciences, City, University of London, Myddelton Street Building, 1 Myddelton Street, London, EC1R 1UW, United Kingdom, 44 07817027035, jacqueline.sin@city.ac.uk %K eHealth %K family carers %K qualitative research %K psychosis %K peer support %K web-based psychoeducation %K mobile phone %D 2022 %7 2.2.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based mental health interventions offer a novel, accessible, and self-paced approach to care delivery to family carers (ie, relatives and close friends who support a loved one with psychosis). We coproduced COPe-support (Carers fOr People with Psychosis e-support), a psychoeducational intervention delivered via an enriched web-based learning environment with network support from professionals and peers. In addition to the rigorous investigation of the effectiveness of COPe-support on the well-being of carers and mental health outcomes, it is imperative to understand the experiences of using the web-based intervention by carers and its associated web-based implementation and facilitation strategies. Objective: This study aims to explore the experiences of carers and perceived acceptability of COPe-support and its different components, how carers found engagement with COPe-support affected their own well-being and caregiving, and the ideas of carers for improving COPe-support and its delivery to inform any future wider implementation. Methods: We conducted a qualitative study, individually interviewing 35 carers, following their use of COPe-support for 8 months through a web-based, randomized controlled trial across England. A semistructured guide with open-ended questions was used to explore the experiences of carers and perceived acceptability of the intervention and their ideas to improve the provision. All interviews were conducted remotely through mobile phones or internet communication media, audio recorded and transcribed verbatim. We used a thematic analysis framework to analyze the data. Results: Three key themes were identified: remote, flexible, and personalized support; impacts on well-being and outlook on caregiving; and future implementation and integration with existing services. Overall, carers found COPe-support a flexible source of knowledge and support from professionals and peers that they could personalize to suit their own needs and convenience. Participants described gaining self-confidence, hope, and a sense of connectivity with others in a similar situation, which helped ameliorate isolation and perceived stigma. Most importantly, COPe-support promoted self-care among the carers themselves. Participants’ experiences, use, and activity on COPe-support varied greatly and differed among carers of various ages and levels of computer literacy. Conclusions: Nearly all participants had a positive experience with COPe-support and supported its wider implementation as a beneficial adjunctive support resource for carers in the future. Any future scale-up of such an intervention needs to consider feedback from carers and suggestions for further improvement. These included having more graphics and audiovisual content materials, improving the navigation, and building in more interactional and customization options to suit various user styles, such as emoji reactions, live web-based chat, opting in and out of updates, and choosing the frequency of reminders. To ensure successful implementation, we should also consider factors pertinent to reaching more carers and integrating the web-based resources with other conventional services. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 89563420; https://www.isrctn.com/ISRCTN89563420 International Registered Report Identifier (IRRID): RR2-10.1186/s12888-020-02528-w %M 35107439 %R 10.2196/27781 %U https://www.jmir.org/2022/2/e27781 %U https://doi.org/10.2196/27781 %U http://www.ncbi.nlm.nih.gov/pubmed/35107439 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e34574 %T Behavioral Efficacy of a Sexual Health Mobile App for Men Who Have Sex With Men: Randomized Controlled Trial of Mobile Messaging for Men %A Sullivan,Patrick Sean %A Stephenson,Rob %A Hirshfield,Sabina %A Mehta,Cyra Christina %A Zahn,Ryan %A Bauermeister,Jose A %A Horvath,Keith %A Chiasson,Mary Ann %A Gelaude,Deborah %A Mullin,Shelby %A Downing Jr,Martin J %A Olansky,Evelyn Jolene %A Wiatrek,Sarah %A Rogers,Erin Q %A Rosenberg,Eli %A Siegler,Aaron J %A Mansergh,Gordon %+ Department of Epidemiology, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, Atlanta, GA, 30322, United States, 1 404 210 6039, pssulli@emory.edu %K HIV prevention %K mHealth %K tool %K video %K randomized clinical trial %K app %K prevention %K HIV %K PrEP %K STI %K testing %K behavior %K efficacy %K men who have sex with men %K MSM %K sexuality %K gay %K bisexual %K United States %D 2022 %7 2.2.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Gay, bisexual, and other men who have sex with men (GBMSM) face the highest burden of HIV in the United States, and there is a paucity of efficacious mobile health (mHealth) HIV prevention and care interventions tailored specifically for GBMSM. We tested a mobile app combining prevention messages and access to core prevention services for GBMSM. Objective: This study aims to measure the efficacy of the Mobile Messaging for Men (M-cubed) app and related services to increase HIV prevention and care behaviors in diverse US GBMSM. Methods: We conducted a randomized open-label study with a waitlist control group among GBMSM in 3 groups (low-risk HIV-negative group, high-risk HIV-negative group, and living-with-HIV [LWH] group) recruited online and in venues in Atlanta, Detroit, and New York City. Participants were randomly assigned to receive access to the app immediately or at 9 months after randomization. The app provided prevention messages in 6 domains of sexual health and offered ordering of at-home HIV and sexually transmitted infection test kits, receiving preexposure prophylaxis (PrEP) evaluations and navigation, and service locators. Serostatus- and risk-specific prevention outcomes were evaluated at baseline, at the end of the intervention period, and at 3, 6, and 9 months after the intervention period. Results: In total, 1226 GBMSM were enrolled and randomized; of these 611 (49.84%) were assigned to the intervention group and 608 (99.51%) were analyzed, while 615 (50.16%) were assigned to the control group and 612 (99.51%) were analyzed. For high-risk GBMSM, allocation to the intervention arm was associated with higher odds of HIV testing during the intervention period (adjusted odds ratio [aOR] 2.02, 95% CI 1.11-3.66) and with higher odds of using PrEP in the 3 months after the intervention period (aOR 2.41, 95% CI 1.00-5.76, P<.05). No changes in HIV prevention or care were associated with allocation to the intervention arm for the low-risk HIV-negative and LWH groups. Conclusions: Access to the M-cubed app was associated with increased HIV testing and PrEP use among high-risk HIV-negative GBMSM in 3 US cities. The app could be made available through funded HIV prevention providers; additional efforts are needed to understand optimal strategies to implement the app outside of the research setting. Trial Registration: ClinicalTrials.gov NCT03666247; https://clinicaltrials.gov/ct2/show/NCT03666247 International Registered Report Identifier (IRRID): RR2-10.2196/16439 %M 35025755 %R 10.2196/34574 %U https://www.jmir.org/2022/2/e34574 %U https://doi.org/10.2196/34574 %U http://www.ncbi.nlm.nih.gov/pubmed/35025755 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 1 %P e32112 %T Adoption of the Website and Mobile App of a Preventive Health Program Across Neighborhoods With Different Socioeconomic Conditions in the Netherlands: Longitudinal Study %A Agachi,Elena %A Bijmolt,Tammo H A %A Mierau,Jochen O %A van Ittersum,Koert %+ Department of Marketing, Faculty of Economics and Business, University of Groningen, PO Box 800, Groningen, 9700 AV, Netherlands, 31 50 363 3686, e.agachi@rug.nl %K eHealth %K mHealth %K mobile health %K mobile app %K internet %K preventive health program %K health disparities %K NSES %K program adoption %K survival analysis %D 2022 %7 2.2.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Socioeconomic disparities in the adoption of preventive health programs represent a well-known challenge, with programs delivered via the web serving as a potential solution. The preventive health program examined in this study is a large-scale, open-access web-based platform operating in the Netherlands, which aims to improve the health behaviors and wellness of its participants. Objective: This study aims to examine the differences in the adoption of the website and mobile app of a web-based preventive health program across socioeconomic groups. Methods: The 83,466 participants in this longitudinal, nonexperimental study were individuals who had signed up for the health program between July 2012 and September 2019. The rate of program adoption per delivery means was estimated using the Prentice, Williams, and Peterson Gap–Time model, with the measure of neighborhood socioeconomic status (NSES) used to distinguish between population segments with different socioeconomic characteristics. Registration to the health program was voluntary and free, and not within a controlled study setting, allowing the observation of the true rate of adoption. Results: The estimation results indicate that program adoption across socioeconomic groups varies depending on the program’s delivery means. For the website, higher NSES groups have a higher likelihood of program adoption compared with the lowest NSES group (hazard ratio 1.03, 95% CI 1.01-1.05). For the mobile app, the opposite holds: higher NSES groups have a lower likelihood of program adoption compared with the lowest NSES group (hazard ratio 0.94, 95% CI 0.91-0.97). Conclusions: Promoting preventive health programs using mobile apps can help to increase program adoption among the lowest socioeconomic segments. Given the increasing use of mobile phones among disadvantaged population groups, structuring future health interventions to include mobile apps as means of delivery can support the stride toward diminishing health disparities. %M 35107433 %R 10.2196/32112 %U https://humanfactors.jmir.org/2022/1/e32112 %U https://doi.org/10.2196/32112 %U http://www.ncbi.nlm.nih.gov/pubmed/35107433 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 2 %P e30410 %T Remote Assessment of Cardiovascular Risk Factors and Cognition in Middle-Aged and Older Adults: Proof-of-Concept Study %A Eastman,Jennifer A %A Kaup,Allison R %A Bahorik,Amber L %A Butcher,Xochitl %A Attarha,Mouna %A Marcus,Gregory M %A Pletcher,Mark J %A Olgin,Jeffrey E %A Barnes,Deborah E %A Yaffe,Kristine %+ San Francisco VA Medical Center, 4150 Clement St., San Francisco, CA, 94121, United States, 1 951 760 6711, jennifer.eastman@ucsf.edu %K mHealth %K internet %K mobile health %K digital health %K eHealth %K cardiovascular %K risk factors %K cognition %K cognitive impairment %K remote cognitive assessment %K aging %D 2022 %7 2.2.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Adults with cardiovascular disease risk factors (CVRFs) are also at increased risk of developing cognitive decline and dementia. However, it is often difficult to study the relationships between CVRFs and cognitive function because cognitive assessment typically requires time-consuming in-person neuropsychological evaluations that may not be feasible for real-world situations. Objective: We conducted a proof-of-concept study to determine if the association between CVRFs and cognitive function could be detected using web-based, self-administered cognitive tasks and CVRF assessment. Methods: We recruited 239 participants aged ≥50 years (mean age 62.7 years, SD 8.8; 42.7% [n=102] female, 88.7% [n=212] White) who were enrolled in the Health eHeart Study, a web-based platform focused on cardiac disease. The participants self-reported CVRFs (hypertension, high cholesterol, diabetes, and atrial fibrillation) using web-based health surveys between August 2016 and July 2018. After an average of 3 years of follow-up, we remotely evaluated episodic memory, working memory, and executive function via the web-based Posit Science platform, BrainHQ. Raw data were normalized and averaged into 3 domain scores. We used linear regression models to examine the association between CVRFs and cognitive function. Results: CVRF prevalence was 62.8% (n=150) for high cholesterol, 45.2% (n=108) for hypertension, 10.9% (n=26) for atrial fibrillation, and 7.5% (n=18) for diabetes. In multivariable models, atrial fibrillation was associated with worse working memory (β=-.51, 95% CI -0.91 to -0.11) and worse episodic memory (β=-.31, 95% CI -0.59 to -0.04); hypertension was associated with worse episodic memory (β=-.27, 95% CI -0.44 to -0.11). Diabetes and high cholesterol were not associated with cognitive performance. Conclusions: Self-administered web-based tools can be used to detect both CVRFs and cognitive health. We observed that atrial fibrillation and hypertension were associated with worse cognitive function even in those in their 60s and 70s. The potential of mobile assessments to detect risk factors for cognitive aging merits further investigation. %M 35107430 %R 10.2196/30410 %U https://formative.jmir.org/2022/2/e30410 %U https://doi.org/10.2196/30410 %U http://www.ncbi.nlm.nih.gov/pubmed/35107430 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 2 %P e33374 %T An Internet-Based Cognitive Behavioral Therapy Program for Anxiety and Depression (Tranquility): Adaptation Co-design and Fidelity Evaluation Study %A Patterson,Victoria C %A Rossi,Meghan A %A Pencer,Alissa %A Wozney,Lori %+ Department of Psychology and Neuroscience, Dalhousie University, P.O. Box 15000, Halifax, NS, B3H 4R2, Canada, 1 9024944466, alissa.pencer@dal.ca %K cognitive behavioral therapy %K anxiety %K depression %K fidelity %K usability %D 2022 %7 2.2.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Internet-based cognitive behavioral therapy (iCBT) is a necessary step toward increasing the accessibility of mental health services. Yet, few iCBT programs have been evaluated for their fidelity to the therapeutic principles of cognitive behavioral therapy (CBT) or usability standards. In addition, many existing iCBT programs do not include treatments targeting both anxiety and depression, which are commonly co-occurring conditions. Objective: This study aims to evaluate the usability of Tranquility—a novel iCBT program for anxiety—and its fidelity to CBT principles. This study also aims to engage in a co-design process to adapt Tranquility to include treatment elements for depression. Methods: CBT experts (n=6) and mental health–informed peers (n=6) reviewed the iCBT program Tranquility. CBT experts assessed Tranquility’s fidelity to CBT principles and were asked to identify necessary interventions for depression by using 2 simulated client case examples. Mental health–informed peers engaged in 2 co-design focus groups to discuss adaptations to the existing anxiety program and the integration of interventions for depression. Both groups completed web-based surveys assessing the usability of Tranquility and the likelihood that they would recommend the program. Results: The CBT experts’ mean rating of Tranquility’s fidelity to CBT principles was 91%, indicating a high fidelity to CBT. Further, 5 out of 6 CBT experts and all mental health–informed peers (all participants: 11/12, 88%) rated Tranquility as satisfactory, indicating that they may recommend Tranquility to others, and they rated its usability highly (mean 76.56, SD 14.07). Mental health–informed peers provided suggestions on how to leverage engagement with Tranquility (eg, adding incentives and notification control). Conclusions: This preliminary study demonstrated the strong fidelity of Tranquility to CBT and usability standards. The results highlight the importance of involving stakeholders in the co-design process and future opportunities to increase engagement. %M 34910660 %R 10.2196/33374 %U https://formative.jmir.org/2022/2/e33374 %U https://doi.org/10.2196/33374 %U http://www.ncbi.nlm.nih.gov/pubmed/34910660 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e30416 %T Long-term Effectiveness of a Smartphone App Combined With a Smart Band on Weight Loss, Physical Activity, and Caloric Intake in a Population With Overweight and Obesity (Evident 3 Study): Randomized Controlled Trial %A Lugones-Sanchez,Cristina %A Recio-Rodriguez,Jose I %A Agudo-Conde,Cristina %A Repiso-Gento,Irene %A G Adalia,Esther %A Ramirez-Manent,José Ignacio %A Sanchez-Calavera,Maria Antonia %A Rodriguez-Sanchez,Emiliano %A Gomez-Marcos,Manuel A %A Garcia-Ortiz,Luis %A , %+ Primary Care Research Unit of Salamanca (APISAL), Institute of Biomedical Research of Salamanca, Health Service of Castilla y León, Avda Portugal 83, 2nd Fl., Salamanca, 37005, Spain, 34 923291100 ext 54750, crislugsa@gmail.com %K mobile app %K telemedicine %K eHealth %K weight control %K exercise %K obesity %K mobile phone %D 2022 %7 1.2.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Multicomponent mobile health approaches can improve lifestyle intervention results, although little is known about their long-term effectiveness. Objective: This study aims to evaluate the long-term effectiveness (12 months) of a multicomponent mobile health intervention—combining a smartphone app, an activity tracker wristband, and brief counseling, compared with a brief counseling group only—on weight loss and improving body composition, physical activity, and caloric intake in Spanish sedentary adults with overweight or obesity. Methods: We conducted a randomized controlled, multicenter clinical trial (Evident 3). A total of 650 participants were recruited from 5 primary care centers, with 318 participants in the intervention group (IG) and 332 in the control group (CG). All participants were briefly counseled about a healthy diet and physical activity at the baseline visit. For the 3-month intervention period, the IG received training to use the app to promote healthy lifestyles and the smart band (Mi Band 2, Xiaomi). All measurements were performed at baseline and at 3 and 12 months. Physical activity was measured using the International Physical Activity Questionnaire–Short Form. Nutritional habits were assessed using the Food Frequency Questionnaire and Adherence to Mediterranean diet questionnaire. Results: Of the 650 participants included, 563 (86.6%) completed the 3-month visit and 443 (68.2%) completed the 12-month visit. After 12 months, the IG showed net differences in weight (−0.26, 95% CI −1.21 to 0.70 kg; P=.02), BMI (−0.06, 95% CI −0.41 to 0.28 points; P=.01), waist-height ratio (−0.25, 95% CI −0.94 to 0.44; P=.03), body adiposity index (−0.33, 95% CI −0.77 to 0.11; P=.03), waist circumference (−0.48, 95% CI −1.62 to 0.66 cm, P=.04) and hip circumference (−0.69, 95% CI –1.62 to 0.25 cm; P=.03). Both groups lowered daily caloric intake and increased adherence to the Mediterranean diet, with no differences between the groups. The IG increased light physical activity time (32.6, 95% CI −30.3 to 95.04 min/week; P=.02) compared with the CG. Analyses by subgroup showed changes in body composition variables in women, people aged >50 years, and married people. Conclusions: The low-intensity intervention of the Evident 3 study showed, in the IG, benefits in weight loss, some body composition variables, and time spent in light physical activity compared with the CG at 3 months, but once the devices were collected, the downward trend was not maintained at the 12-month follow-up. No differences in nutritional outcomes were observed between the groups. Trial Registration: ClinicalTrials.gov NCT03175614; https://clinicaltrials.gov/ct2/show/NCT03175614 International Registered Report Identifier (IRRID): RR2-10.1097/MD.0000000000009633 %M 35103609 %R 10.2196/30416 %U https://www.jmir.org/2022/2/e30416 %U https://doi.org/10.2196/30416 %U http://www.ncbi.nlm.nih.gov/pubmed/35103609 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e30095 %T Effectiveness, Cost-effectiveness, and Cost-Utility of a Digital Alcohol Moderation Intervention for Cancer Survivors: Health Economic Evaluation and Outcomes of a Pragmatic Randomized Controlled Trial %A Mujcic,Ajla %A Blankers,Matthijs %A Boon,Brigitte %A Berman,Anne H %A Riper,Heleen %A van Laar,Margriet %A Engels,Rutger %+ Erasmus School of Social and Behavioural Sciences, Erasmus University Rotterdam, Burgemeester Oudlaan 50, Rotterdam, 3062 PA, Netherlands, 31 30 29 59 256, amujcic@trimbos.nl %K alcohol %K brief interventions %K cancer survivors %K effectiveness %K cost-effectiveness %K eHealth %K mobile phone %D 2022 %7 1.2.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Alcohol moderation (AM) interventions may contribute to better treatment outcomes and the general well-being of cancer survivors. Objective: This study evaluates the effectiveness, cost-effectiveness, and cost-utility of MyCourse, a digital AM intervention, compared with a noninteractive digital information brochure for cancer survivors. Methods: A health economic evaluation alongside a pragmatic 2-arm parallel-group randomized controlled trial was conducted with follow-ups at 3, 6, and 12 months after randomization. The study was conducted on the web in the Netherlands from 2016 to 2019. Participants were adult 10-year cancer survivors drinking over the Dutch-recommended drinking guidelines (≤7 standard units [10 g of alcohol] per week) with the intention to moderate or quit drinking. Overall, 103 participants were randomized and analyzed: 53 (51.5%) in the MyCourse group and 50 (48.5%) in the control group. In the MyCourse group, participants had access to a newly developed, digital, minimally guided AM intervention, MyCourse–Moderate Drinking. The primary outcome was the self-reported number of standard drinks (10 g of ethanol) consumed in the past 7 days at the 6-month follow-up. The secondary outcome measures were alcohol-related problems as measured by the Alcohol Use Disorders Identification Test (AUDIT) and treatment satisfaction. For the health economic evaluation, health care costs, costs because of productivity losses, and intervention costs were assessed over a 12-month horizon. Results: Alcohol use at the 6-month follow-up decreased by 38% in the MyCourse group and by 33% in the control group. No difference in 7-day alcohol use was found between the groups (B=2.1, 95% CI −7.6 to 3.1; P=.22) at any of the follow-ups. AUDIT scores for alcohol-related problems decreased over time in both groups, showing no significant difference between the groups (Cohen d=0.3, 95% CI −0.1 to 0.6; P=.21). Intervention costs per participant were estimated at US $279 for the MyCourse group and US $74 for the control group. The mean societal costs were US $18,092 (SD 25,662) and US $23,496 (SD 34,327), respectively. The MyCourse group led to fewer gained quality-adjusted life years at lower societal costs in the cost-utility analysis. In the cost-effectiveness analysis, the MyCourse group led to a larger reduction in drinking units over time at lower societal costs (incremental cost-effectiveness ratio per reduced drink: US $ −1158, 95% CI −1609 to −781). Conclusions: At 6 months, alcohol use was reduced by approximately one-third in both groups, with no significant differences between the digital intervention MyCourse and a noninteractive web-based brochure. At 12 months, cost-effectiveness analyses showed that MyCourse led to a larger reduction in drinking units over time, at lower societal costs. The MyCourse group led to marginally fewer gained quality-adjusted life years, also at lower societal costs. Trial Registration: Netherlands Trial Register NTR6010; https://www.trialregister.nl/trial/5433 International Registered Report Identifier (IRRID): RR2-10.1186/s12885-018-4206-z %M 35103605 %R 10.2196/30095 %U https://www.jmir.org/2022/2/e30095 %U https://doi.org/10.2196/30095 %U http://www.ncbi.nlm.nih.gov/pubmed/35103605 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 2 %P e31911 %T Elements That Underpin the Design, Development, and Evaluation of Social Media Health Interventions: Protocol for a Scoping Review %A Nizam,Mohammed Zayan %A Powell,Leigh %A Zary,Nabil %+ Institute for Excellence in Health Professions Education, Mohammed Bin Rashid University of Medicine and Health Sciences, Building 14, Dubai Healthcare City, PO Box 505055, Dubai, 800 MBRU, United Arab Emirates, 971 585960762, Nabil.Zary@mbru.ac.ae %K social media %K health intervention %K behavior change models %K health improvement %K intervention design %K models of design %K evaluating interventions %D 2022 %7 1.2.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Social media use has grown tremendously over the years. Given the volume and diversity of people on social media and the amount of information being exchanged, it is perhaps unsurprising that social media is being used as an avenue to disseminate and deliver health interventions. There exists an opportunity for social media health interventions to make a positive impact on health. However, there is a need to understand more about the ways in which these interventions are designed, developed, and evaluated. This scoping protocol will review the current state of this field by charting the elements that drive the design, development, and evaluation of these interventions. This includes charting models, frameworks, and rationales for the interventions, as well as the platforms being used, and the health behaviors being targeted. This intention of this scoping review is to help inform those who wish to develop effective social media health interventions. Objective: The objective of this review is to map the elements that drive the design, development, and evaluation of social media health interventions. We define “social media health intervention” as interventions that make use of social media platforms to disseminate or deliver health-related information and educational initiatives to the public. We will seek to chart the elements that drive the design, development, and delivery of such interventions, including their platforms and targeted health behaviors. Methods: The methodological framework for this review is guided by Arksey and O’Malley and enhancements by later studies. We will search relevant literature from 9 databases: (1) PubMed, (2) PsycINFO, (3) EMBASE, (4) Web of Science, (5) Scopus, (6) CINAHL, (7) ERIC, (8) MEDLINE, and (9) Google Scholar. The literature will be screened by at least two reviewers in 2 stages: (1) title/abstract screening against the eligibility criteria; and (2) eligible articles will then undergo a full-text screening. Data will be charted using the data charting tool developed by the authors. Results: The results of this study will be presented in a final scoping review paper, divided into 2 sections. The first section will describe the search strategy and study selection process and will contain the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flowchart. The second section will provide key details pertaining to the review objective and question. Conclusions: This review will help guide scholars looking to build social media health interventions toward evidence-based practices in design and evaluation. International Registered Report Identifier (IRRID): PRR1-10.2196/31911 %M 34848388 %R 10.2196/31911 %U https://www.researchprotocols.org/2022/2/e31911 %U https://doi.org/10.2196/31911 %U http://www.ncbi.nlm.nih.gov/pubmed/34848388 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 1 %P e30583 %T Investigating When, Which, and Why Users Stop Using a Digital Health Intervention to Promote an Active Lifestyle: Secondary Analysis With A Focus on Health Action Process Approach–Based Psychological Determinants %A Schroé,Helene %A Crombez,Geert %A De Bourdeaudhuij,Ilse %A Van Dyck,Delfien %+ Department of Movement and Sports Sciences, Faculty of Medicine and Health, Ghent University, Watersportlaan 2, Ghent, 9000, Belgium, 32 9264 63 63, helene.schroe@ugent.be %K digital health %K psychosocial determinants %K health action process approach %K physical activity %K sedentary behavior %K attrition %K dropout %K mobile health %K healthy life style %K health behaviors %D 2022 %7 31.1.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Digital health interventions have gained momentum to change health behaviors such as physical activity (PA) and sedentary behavior (SB). Although these interventions show promising results in terms of behavior change, they still suffer from high attrition rates, resulting in a lower potential and accessibility. To reduce attrition rates in the future, there is a need to investigate the reasons why individuals stop using the interventions. Certain demographic variables have already been related to attrition; however, the role of psychological determinants of behavior change as predictors of attrition has not yet been fully explored. Objective: The aim of this study was to examine when, which, and why users stopped using a digital health intervention. In particular, we aimed to investigate whether psychological determinants of behavior change were predictors for attrition. Methods: The sample consisted of 473 healthy adults who participated in the intervention MyPlan 2.0 to promote PA or reduce SB. The intervention was developed using the health action process approach (HAPA) model, which describes psychological determinants that guide individuals in changing their behavior. If participants stopped with the intervention, a questionnaire with 8 question concerning attrition was sent by email. To analyze when users stopped using the intervention, descriptive statistics were used per part of the intervention (including pre- and posttest measurements and the 5 website sessions). To analyze which users stopped using the intervention, demographic variables, behavioral status, and HAPA-based psychological determinants at pretest measurement were investigated as potential predictors of attrition using logistic regression models. To analyze why users stopped using the intervention, descriptive statistics of scores to the attrition-related questionnaire were used. Results: The study demonstrated that 47.9% (227/473) of participants stopped using the intervention, and drop out occurred mainly in the beginning of the intervention. The results seem to indicate that gender and participant scores on the psychological determinants action planning, coping planning, and self-monitoring were predictors of first session, third session, or whole intervention completion. The most endorsed reasons to stop using the intervention were the time-consuming nature of questionnaires (55%), not having time (50%), dissatisfaction with the content of the intervention (41%), technical problems (39%), already meeting the guidelines for PA/SB (31%), and, to a lesser extent, the experience of medical/emotional problems (16%). Conclusions: This study provides some directions for future studies. To decrease attrition, it will be important to personalize interventions on different levels, questionnaires (either for research purposes or tailoring) should be kept to a minimum especially in the beginning of interventions by, for example, using objective monitoring devices, and technical aspects of digital health interventions should be thoroughly tested in advance. Trial Registration: ClinicalTrials.gov NCT03274271; https://clinicaltrials.gov/ct2/show/NCT03274271 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-019-3456-7 %M 35099400 %R 10.2196/30583 %U https://mhealth.jmir.org/2022/1/e30583 %U https://doi.org/10.2196/30583 %U http://www.ncbi.nlm.nih.gov/pubmed/35099400 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e31674 %T The Effect of Internet-Delivered Cognitive Behavioral Therapy Versus Psychoeducation Only on Psychological Distress in Patients With Noncardiac Chest Pain: Randomized Controlled Trial %A Mourad,Ghassan %A Eriksson-Liebon,Magda %A Karlström,Patric %A Johansson,Peter %+ Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden, 46 +46736209582, ghassan.mourad@liu.se %K cardiac anxiety %K cognitive behavioral therapy %K health-related quality of life %K internet delivered %K noncardiac chest pain %K psychological distress %D 2022 %7 28.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Patients with recurrent episodes of noncardiac chest pain (NCCP) experience cardiac anxiety as they misinterpret the pain to be cardiac related and avoid physical activity that they think could threaten their lives. Psychological interventions, such as internet-delivered cognitive behavioral therapy (iCBT), targeting anxiety can be a feasible solution by supporting patients to learn how to perceive and handle their chest pain. Objective: This study aims to evaluate the effects of a nurse-led iCBT program on cardiac anxiety and other patient-reported outcomes in patients with NCCP. Methods: Patients with at least two health care consultations because of NCCP during the past 6 months, and who were experiencing cardiac anxiety (Cardiac Anxiety Questionnaire score ≥24), were randomized into 5 weeks of iCBT (n=54) or psychoeducation (n=55). Patients were aged 54 (SD 17) years versus 57 (SD 16) years and were mainly women (32/54, 59% vs 35/55, 64%). The iCBT program comprised psychoeducation, mindfulness, and exposure to physical activity, with weekly homework assignments. The primary outcome was cardiac anxiety. The secondary outcomes were fear of bodily sensations, depressive symptoms, health-related quality of life, and chest pain frequency. Intention-to-treat analysis was applied, and the patients were followed up for 3 months. Mixed model analysis was used to determine between-group differences in primary and secondary outcomes. Results: No significant differences were found between the iCBT and psychoeducation groups regarding cardiac anxiety or any of the secondary outcomes in terms of the interaction effect of time and group over the 3-month follow-up. iCBT demonstrated a small effect size on cardiac anxiety (Cohen d=0.31). In the iCBT group, 36% (16/44) of patients reported a positive reliable change score (≥11 points on the Cardiac Anxiety Questionnaire), and thus an improvement in cardiac anxiety, compared with 27% of (13/48) patients in the psychoeducation group. Within-group analysis showed further significant improvement in cardiac anxiety (P=.04) at the 3-month follow-up compared with the 5-week follow-up in the iCBT group but not in the psychoeducation group. Conclusions: iCBT was not superior to psychoeducation in decreasing cardiac anxiety in patients with NCCP. However, iCBT tends to have better long-term effects on psychological distress, including cardiac anxiety, health-related quality of life, and NCCP frequency than psychoeducation. The effects need to be followed up to draw more reliable conclusions. Trial Registration: ClinicalTrials.gov NCT03336112; https://www.clinicaltrials.gov/ct2/show/NCT03336112 %M 35089153 %R 10.2196/31674 %U https://www.jmir.org/2022/1/e31674 %U https://doi.org/10.2196/31674 %U http://www.ncbi.nlm.nih.gov/pubmed/35089153 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e21063 %T Digital Health Promotion and Prevention in Settings: Scoping Review %A Stark,Anna Lea %A Geukes,Cornelia %A Dockweiler,Christoph %+ School of Public Health, Centre for ePublic Health, Bielefeld University, Universitätsstraße 25, Bielefeld, 33615, Germany, 49 521 106 67859, lea.stark@uni-bielefeld.de %K setting approach %K health promotion %K health prevention %K eHealth %K internet %K behavior change %K web-based intervention %K technology %K mobile phone %D 2022 %7 28.1.2022 %9 Review %J J Med Internet Res %G English %X Background: Digital technologies are increasingly integrating into people’s daily living environments such as schools, sport clubs, and health care facilities. These settings play a crucial role for health promotion and prevention because they affect the health of their members, as the World Health Organization has declared. Implementing digital health promotion and prevention in settings offers the opportunity to reach specific target groups, lower the costs of implementation, and improve the health of the population. Currently, there is a lack of scientific evidence that reviews the research on digital health promotion and prevention in settings. Objective: This scoping review aims to provide an overview of research targeting digital health promotion and primary prevention in settings. It assesses the range of scientific literature regarding outcomes such as applied technology, targeted setting, and area of health promotion or prevention, as well as identifies research gaps. Methods: The scoping review was conducted following the Levac, Colquhoun, and O'Brien framework. We searched scientific databases and gray literature for articles on digital setting–based health promotion and prevention published from 2010 to January 2020. We included empirical and nonempirical publications in English or German and excluded secondary or tertiary prevention and health promotion at the workplace. Results: From 8888 records, the search resulted in 200 (2.25%) included publications. We identified a huge diversity of literature regarding digital setting–based health promotion and prevention. The variety of technology types extends from computer- and web-based programs to mobile devices (eg, smartphone apps) and telemonitoring devices (sensors). We found analog, digital, and blended settings in which digital health promotion and prevention takes place. The most frequent analog settings were schools (39/200, 19.5%) and neighborhoods or communities (24/200, 12%). Social media apps were also included because in some studies they were defined as a (digital) setting. They accounted for 31.5% (63/200) of the identified settings. The most commonly focused areas of health promotion and prevention were physical activity (81/200, 40.5%), nutrition (45/200, 22.5%), and sexual health (34/200, 17%). Most of the interventions combined several health promotion or prevention methods, including environmental change; providing information, social support, training, or incentives; and monitoring. Finally, we found that the articles mostly reported on behavioral rather than structural health promotion and prevention. Conclusions: The research field of digital health promotion and prevention in settings is heterogeneous. At the same time, we identified research gaps regarding the absence of valid definitions of relevant terms (eg, digital settings) and the lack of literature on structural health promotion and prevention in settings. Therefore, it remains unclear how digital technologies can contribute to structural (or organizational) changes in settings. More research is needed to successfully implement digital technologies to achieve health promotion and prevention in settings. %M 35089140 %R 10.2196/21063 %U https://www.jmir.org/2022/1/e21063 %U https://doi.org/10.2196/21063 %U http://www.ncbi.nlm.nih.gov/pubmed/35089140 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e30673 %T Describing Transitions in Adherence to Physical Activity Self-monitoring and Goal Attainment in an Online Behavioral Weight Loss Program: Secondary Analysis of a Randomized Controlled Trial %A Stansbury,Melissa L %A Harvey,Jean %A Krukowski,Rebecca A %A Pellegrini,Christine A %A Wang,Xuewen %A West,Delia Smith %+ Department of Exercise Science, Arnold School of Public Health, University of South Carolina, Discovery 1 Bldg, Suite 403, 915 Greene Street, Columbia, SC, 29208, United States, 1 803 777 0510, stansbm@email.sc.edu %K physical activity %K adherence %K self-monitoring %K goal attainment %K lifestyle intervention %D 2022 %7 28.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Standard behavioral weight loss interventions often set uniform physical activity (PA) goals and promote PA self-monitoring; however, adherence remains a challenge, and recommendations may not accommodate all individuals. Identifying patterns of PA goal attainment and self-monitoring behavior will offer a deeper understanding of how individuals adhere to different types of commonly prescribed PA recommendations (ie, minutes of moderate-to-vigorous physical activity [MVPA] and daily steps) and guide future recommendations for improved intervention effectiveness. Objective: This study examined weekly patterns of adherence to step-based and minute-based PA goals and self-monitoring behavior during a 6-month online behavioral weight loss intervention. Methods: Participants were prescribed weekly PA goals for steps (7000-10,000 steps/day) and minutes of MVPA (50-200 minutes/week) as part of a lifestyle program. Goals gradually increased during the initial 2 months, followed by 4 months of fixed goals. PA was self-reported daily on the study website. For each week, participants were categorized as adherent if they self-monitored their PA and met the program PA goal, suboptimally adherent if they self-monitored but did not meet the program goal, or nonadherent if they did not self-monitor. The probability of transitioning into a less adherent status was examined using multinomial logistic regression. Results: Participants (N=212) were predominantly middle-aged females with obesity, and 67 (31.6%) self-identified as a racial/ethnic minority. Initially, 73 (34.4%) participants were categorized as adherent to step-based goals, with 110 [51.9%] suboptimally adherent and 29 [13.7%] nonadherent, and there was a high probability of either remaining suboptimally adherent from week to week or transitioning to a nonadherent status. However, 149 (70.3%) participants started out adherent to minute-based goals (34 [16%] suboptimally adherent and 29 [13.7%] nonadherent), with suboptimally adherent seen as the most variable status. During the graded goal phase, participants were more likely to transition to a less adherent status for minute-based goals (odds ratio [OR] 1.39, 95% CI 1.31-1.48) compared to step-based goals (OR 1.24, 95% CI 1.17-1.30); however, no differences were seen during the fixed goal phase (minute-based goals: OR 1.06, 95% CI 1.05-1.08; step-based goals: OR 1.07, 95% CI 1.05-1.08). Conclusions: States of vulnerability to poor PA adherence can emerge rapidly and early in obesity treatment. There is a window of opportunity within the initial 2 months to bring more people toward adherent behavior, especially those who fail to meet the prescribed goals but engage in self-monitoring. Although this study describes the probability of adhering to step- and minute-based targets, it will be prudent to determine how individual characteristics and contextual states relate to these behavioral patterns, which can inform how best to adapt interventions. Trial Registration: ClinicalTrials.gov NCT02688621; https://clinicaltrials.gov/ct2/show/NCT02688621 %M 35089159 %R 10.2196/30673 %U https://www.jmir.org/2022/1/e30673 %U https://doi.org/10.2196/30673 %U http://www.ncbi.nlm.nih.gov/pubmed/35089159 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 1 %P e26049 %T FOCUS mHealth Intervention for Veterans With Serious Mental Illness in an Outpatient Department of Veterans Affairs Setting: Feasibility, Acceptability, and Usability Study %A Buck,Benjamin %A Nguyen,Janelle %A Porter,Shelan %A Ben-Zeev,Dror %A Reger,Greg M %+ Behavioral Research in Technology and Engineering (BRiTE) Center, Department of Psychiatry and Behavioral Sciences, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, United States, 1 206 221 8518, buckbe@uw.edu %K mHealth %K veterans %K schizophrenia %K serious mental illness %K mobile phone %D 2022 %7 28.1.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Veterans with serious mental illnesses (SMIs) face barriers to accessing in-person evidence-based interventions that improve illness management. Mobile health (mHealth) has been demonstrated to be feasible, acceptable, effective, and engaging among individuals with SMIs in community mental health settings. mHealth for SMIs has not been tested within the Department of Veterans Affairs (VA). Objective: This study examines the feasibility, acceptability, and preliminary effectiveness of an mHealth intervention for SMI in the context of VA outpatient care. Methods: A total of 17 veterans with SMIs were enrolled in a 1-month pilot trial of FOCUS, a smartphone-based self-management intervention for SMI. At baseline and posttest, they completed measures examining symptoms and functional recovery. The participants provided qualitative feedback related to the usability and acceptability of the intervention. Results: Veterans completed on an average of 85.0 (SD 96.1) interactions with FOCUS over the 1-month intervention period. They reported high satisfaction, usability, and acceptability, with nearly all participants (16/17, 94%) reporting that they would recommend the intervention to a fellow veteran. Clinicians consistently reported finding mHealth-related updates useful for informing their care. Qualitative feedback indicated that veterans thought mHealth complemented their existing VA services well and described potential opportunities to adapt FOCUS to specific subpopulations (eg, combat veterans) as well as specific delivery modalities (eg, groups). In the 1-month period, the participants experienced small improvements in self-assessed recovery, auditory hallucinations, and quality of life. Conclusions: The FOCUS mHealth intervention is feasible, acceptable, and usable among veterans. Future work should develop and examine VA-specific implementation approaches of FOCUS for this population. %M 35089151 %R 10.2196/26049 %U https://mental.jmir.org/2022/1/e26049 %U https://doi.org/10.2196/26049 %U http://www.ncbi.nlm.nih.gov/pubmed/35089151 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 1 %P e31712 %T Social Equity in the Efficacy of Computer-Based and In-Person Brief Alcohol Interventions Among General Hospital Patients With At-Risk Alcohol Use: A Randomized Controlled Trial %A Freyer-Adam,Jennis %A Baumann,Sophie %A Bischof,Gallus %A Staudt,Andreas %A Goeze,Christian %A Gaertner,Beate %A John,Ulrich %+ Institute for Medical Psychology, University Medicine Greifswald, Walther-Rathenau-Str. 48, Greifswald, 17475, Germany, 49 3834865606, Jennis.Freyer-Adam@med.uni-greifswald.de %K brief alcohol intervention %K electronic %K eHealth %K digital %K motivational interviewing %K socioeconomic status %K equity %K social inequality %K transtheoretical model %K moderator %K mental health %K public health %K alcohol interventions %K digital intervention %K digital health intervention %K alcohol use %D 2022 %7 28.1.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Social equity in the efficacy of behavior change intervention is much needed. While the efficacy of brief alcohol interventions (BAIs), including digital interventions, is well established, particularly in health care, the social equity of interventions has been sparsely investigated. Objective: We aim to investigate whether the efficacy of computer-based versus in-person delivered BAIs is moderated by the participants’ socioeconomic status (ie, to identify whether general hospital patients with low-level education and unemployed patients may benefit more or less from one or the other way of delivery compared to patients with higher levels of education and those that are employed). Methods: Patients with nondependent at-risk alcohol use were identified through systematic offline screening conducted on 13 general hospital wards. Patients were approached face-to-face and asked to respond to an app for self-assessment provided by a mobile device. In total, 961 (81% of eligible participants) were randomized and received their allocated intervention: computer-generated and individually tailored feedback letters (CO), in-person counseling by research staff trained in motivational interviewing (PE), or assessment only (AO). CO and PE were delivered on the ward and 1 and 3 months later, were based on the transtheoretical model of intentional behavior change and required the assessment of intervention data prior to each intervention. In CO, the generation of computer-based feedback was created automatically. The assessment of data and sending out feedback letters were assisted by the research staff. Of the CO and PE participants, 89% (345/387) and 83% (292/354) received at least two doses of intervention, and 72% (280/387) and 54% (191/354) received all three doses of intervention, respectively. The outcome was change in grams of pure alcohol per day after 6, 12, 18, and 24 months, with the latter being the primary time-point of interest. Follow-up interviewers were blinded. Study group interactions with education and employment status were tested as predictors of change in alcohol use using latent growth modeling. Results: The efficacy of CO and PE did not differ by level of education (P=.98). Employment status did not moderate CO efficacy (Ps≥.66). Up to month 12 and compared to employed participants, unemployed participants reported significantly greater drinking reductions following PE versus AO (incidence rate ratio 0.44, 95% CI 0.21-0.94; P=.03) and following PE versus CO (incidence rate ratio 0.48, 95% CI 0.24–0.96; P=.04). After 24 months, these differences were statistically nonsignificant (Ps≥.31). Conclusions: Computer-based and in-person BAI worked equally well independent of the patient’s level of education. Although findings indicate that in the short-term, unemployed persons may benefit more from BAI when delivered in-person rather than computer-based, the findings suggest that both BAIs have the potential to work well among participants with low socioeconomic status. Trial Registration: ClinicalTrials.gov NCT01291693; https://clinicaltrials.gov/ct2/show/NCT01291693 %M 35089156 %R 10.2196/31712 %U https://mental.jmir.org/2022/1/e31712 %U https://doi.org/10.2196/31712 %U http://www.ncbi.nlm.nih.gov/pubmed/35089156 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e23762 %T Quality of Life and Multilevel Contact Network Structures Among Healthy Adults in Taiwan: Online Participatory Cohort Study %A Yen,Tso-Jung %A Chan,Ta-Chien %A Fu,Yang-Chih %A Hwang,Jing-Shiang %+ Institute of Statistical Science, Academia Sinica, Environmental Changes Research Building, No.128, Academia Road, Section 2, Nankang, Taipei, 11529, Taiwan, 886 0981451477, tjyen@stat.sinica.edu.tw %K contact diary %K egocentric networks %K social support %K weak ties %K World Health Organization Quality of Life Survey %K quality of life %K networks %K demography %K society %D 2022 %7 28.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: People’s quality of life diverges on their demographics, socioeconomic status, and social connections. Objective: By taking both demographic and socioeconomic features into account, we investigated how quality of life varied on social networks using data from both longitudinal surveys and contact diaries in a year-long (2015-2016) study. Methods: Our 4-wave, repeated measures of quality of life followed the brief version of the World Health Organization Quality of Life scale (WHOQOL-BREF). In our regression analysis, we integrated these survey measures with key time-varying and multilevel network indices based on contact diaries. Results: People’s quality of life may decrease if their daily contacts contain high proportions of weak ties. In addition, people tend to perceive a better quality of life when their daily contacts are face-to-face or initiated by others or when they contact someone who is in a good mood or someone with whom they can discuss important life issues. Conclusions: Our findings imply that both functional and structural aspects of the social network play important but different roles in shaping people’s quality of life. %M 35089142 %R 10.2196/23762 %U https://www.jmir.org/2022/1/e23762 %U https://doi.org/10.2196/23762 %U http://www.ncbi.nlm.nih.gov/pubmed/35089142 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e31858 %T Methods for Human-Centered eHealth Development: Narrative Scoping Review %A Kip,Hanneke %A Keizer,Julia %A da Silva,Marcia C %A Beerlage-de Jong,Nienke %A Köhle,Nadine %A Kelders,Saskia M %+ Centre for eHealth and Wellbeing Research, Department of Psychology, Health and Technology, University of Twente, Drienerlolaan 5, Enschede, 7500 AE, Netherlands, 31 +31534896536, h.kip@utwente.nl %K eHealth %K community-based participatory research %K human-centered design %K CeHRes Roadmap %K internet-based intervention %K technological innovations %D 2022 %7 27.1.2022 %9 Review %J J Med Internet Res %G English %X Background: Thorough holistic development of eHealth can contribute to a good fit among the technology, its users, and the context. However, despite the availability of frameworks, not much is known about specific research activities for different aims, phases, and settings. This results in researchers having to reinvent the wheel. Consequently, there is a need to synthesize existing knowledge on research activities for participatory eHealth development processes. Objective: The 3 main goals of this review are to create an overview of the development strategies used in studies based on the CeHRes (Center for eHealth Research) Roadmap, create an overview of the goals for which these methods can be used, and provide insight into the lessons learned about these methods. Methods: We included eHealth development studies that were based on the phases and/or principles of the CeHRes Roadmap. This framework was selected because of its focus on participatory, iterative eHealth design in context and to limit the scope of this review. Data were extracted about the type of strategy used, rationale for using the strategy, research questions, and reported information on lessons learned. The most frequently mentioned lessons learned were summarized using a narrative, inductive approach. Results: In the included 160 papers, a distinction was made between overarching development methods (n=10) and products (n=7). Methods are used to gather new data, whereas products can be used to synthesize previously collected data and support the collection of new data. The identified methods were focus groups, interviews, questionnaires, usability tests, literature studies, desk research, log data analyses, card sorting, Delphi studies, and experience sampling. The identified products were prototypes, requirements, stakeholder maps, values, behavior change strategies, personas, and business models. Examples of how these methods and products were applied in the development process and information about lessons learned were provided. Conclusions: This study shows that there is a plethora of methods and products that can be used at different points in the development process and in different settings. To do justice to the complexity of eHealth development, it seems that multiple strategies should be combined. In addition, we found no evidence for an optimal single step-by-step approach to develop eHealth. Rather, researchers need to select the most suitable research methods for their research objectives, the context in which data are collected, and the characteristics of the participants. This study serves as a first step toward creating a toolkit to support researchers in applying the CeHRes Roadmap to practice. In this way, they can shape the most suitable and efficient eHealth development process. %M 35084359 %R 10.2196/31858 %U https://www.jmir.org/2022/1/e31858 %U https://doi.org/10.2196/31858 %U http://www.ncbi.nlm.nih.gov/pubmed/35084359 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e27759 %T Web Portals for Patients With Chronic Diseases: Scoping Review of the Functional Features and Theoretical Frameworks of Telerehabilitation Platforms %A Morimoto,Yuh %A Takahashi,Tetsuya %A Sawa,Ryuichi %A Saitoh,Masakazu %A Morisawa,Tomoyuki %A Kagiyama,Nobuyuki %A Kasai,Takatoshi %A Dinesen,Birthe %A Hollingdal,Malene %A Refsgaard,Jens %A Daida,Hiroyuki %+ Faculty of Health Science, Juntendo University, 2-1-1 Hongo Bunkyo-ku, Tokyo, 1138421, Japan, 81 338133111 ext 3900, daida@juntendo.ac.jp %K telerehabilitation %K web portal %K chronic disease %K monitoring/data tracking function %K patient-centered care %D 2022 %7 27.1.2022 %9 Review %J J Med Internet Res %G English %X Background: The COVID-19 pandemic has required an increased need for rehabilitation activities applicable to patients with chronic diseases. Telerehabilitation has several advantages, including reducing clinic visits by patients vulnerable to infectious diseases. Digital platforms are often used to assist rehabilitation services for patients in remote settings. Although web portals for medical use have existed for years, the technology in telerehabilitation remains a novel method. Objective: This scoping review investigated the functional features and theoretical approaches of web portals developed for telerehabilitation in patients with chronic diseases. Methods: PubMed and Web of Science were reviewed to identify articles associated with telerehabilitation. Of the 477 nonduplicate articles reviewed, 35 involving 14 portals were retrieved for the scoping review. The functional features, targeted diseases, and theoretical approaches of these portals were studied. Results: The 14 portals targeted patients with chronic obstructive pulmonary disease, cardiovascular, osteoarthritis, multiple sclerosis, cystic fibrosis diseases, and stroke and breast cancer survivors. Monitoring/data tracking and communication functions were the most common, followed by exercise instructions and diary/self-report features. Several theoretical approaches, behavior change techniques, and motivational techniques were found to be utilized. Conclusions: The web portals could unify and display multiple types of data and effectively provide various types of information. Asynchronous correspondence was more favorable than synchronous, real-time interactions. Data acquisition often required assistance from other digital tools. Various functions with patient-centered principles, behavior change strategies, and motivational techniques were observed for better support shifting to a healthier lifestyle. These findings suggested that web portals for telerehabilitation not only provided entrance into rehabilitation programs but also reinforced participant-centered treatment, adherence to rehabilitation, and lifestyle changes over time. %M 35084355 %R 10.2196/27759 %U https://www.jmir.org/2022/1/e27759 %U https://doi.org/10.2196/27759 %U http://www.ncbi.nlm.nih.gov/pubmed/35084355 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 1 %P e29621 %T Impact of Smartphone App–Based Psychological Interventions for Reducing Depressive Symptoms in People With Depression: Systematic Literature Review and Meta-analysis of Randomized Controlled Trials %A Serrano-Ripoll,Maria J %A Zamanillo-Campos,Rocío %A Fiol-DeRoque,Maria A %A Castro,Adoración %A Ricci-Cabello,Ignacio %+ Balearic Islands Health Services, Primary Care Research Unit of Mallorca, Escola Graduada, 3, Palma de Mallorca, 07002, Spain, 34 971175883, mjserranor@yahoo.es %K smartphone technology %K mental health interventions %K depression %K eHealth %K mHealth %K apps %K systematic review %K meta-analysis %K mobile phone %D 2022 %7 27.1.2022 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Depression is a serious, disabling mental disorder that severely affects quality of life. Patients with depression often do not receive adequate treatment. App-based psychotherapy is considered to have great potential to treat depression owing to its reach and easy accessibility. Objective: We aim to analyze the impact of app-based psychological interventions for reducing depressive symptoms in people with depression. Methods: We conducted a systematic literature review and meta-analysis. We searched Medline, Embase, PsycINFO, Web of Science, and Cochrane Central Register of Controlled Trials from inception to December 23, 2020. We selected randomized controlled trials to examine the impact of app-based psychological interventions for reducing depressive symptoms in people with depression. Study selection, data extraction, and critical appraisal (using the Cochrane Risk of Bias tool for randomized studies and the ROBINS-I tool for nonrandomized studies) were conducted independently by 2 reviewers. Where possible, we pooled data using random effects meta-analyses to obtain estimates of the effect size of the intervention. We conducted post hoc meta-regression analyses to explore the factors associated with intervention success. Results: After screening 3468 unique references retrieved from bibliographic searches and assessing the eligibility of 79 full texts, we identified 12 trials (2859 participants) evaluating 14 different interventions. Of 14 trials, 7 (58%) were conducted in the United States; 3 (25%) trials, in Asia (Japan, South Korea, and China); 1 (8%) trial, in Australia; and 1 (8%) trial, in Germany. Of the 12 trials, 5 (42%) trials presented a low risk of bias. The mean duration of the interventions was 6.6 (SD 2.8) weeks. Two-thirds of the interventions were based on cognitive behavioral therapy alone or included it in combination with cognitive control therapy, positive psychology, brief behavioral activation, or mindfulness- and acceptance-based therapy. With no evidence of publication bias, a pooled analysis of 83% (10/12) of the trials and 86% (12/14) of the interventions showed that app-based interventions, compared with a control group receiving usual care or minimal intervention, produced a moderate reduction in depressive symptoms (standardized mean difference [SMD] −0.51, 95% CI −0.69 to −0.33; 2018/2859, 70.58% of the participants; I2=70%). Our meta-regression analyses indicated that there was a greater reduction in symptoms of depression (P=.04) in trials that included participants with moderate to severe depression (SMD −0.67, 95% CI −0.79 to −0.55), compared with trials with participants exhibiting mild to moderate depression (SMD −0.15, 95% CI −0.43 to −0.12). Conclusions: App-based interventions targeted at people with depression produce moderate reductions in the symptoms of depression. More methodologically robust trials are needed to confirm our findings, determine which intervention features are associated with greater improvements, and identify those populations most likely to benefit from this type of intervention. Trial Registration: PROSPERO CRD42019145689; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=145689 %M 35084346 %R 10.2196/29621 %U https://mhealth.jmir.org/2022/1/e29621 %U https://doi.org/10.2196/29621 %U http://www.ncbi.nlm.nih.gov/pubmed/35084346 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 7 %N 1 %P e31451 %T Barriers and Drivers Regarding the Use of Mobile Health Apps Among Patients With Type 2 Diabetes Mellitus in the Netherlands: Explanatory Sequential Design Study %A Bults,Marloes %A van Leersum,Catharina Margaretha %A Olthuis,Theodorus Johannes Josef %A Bekhuis,Robin Enya Marije %A den Ouden,Marjolein Elisabeth Maria %+ Technology, Health & Care Research Group, Saxion University of Applied Sciences, M.H. Tromplaan 28, Enschede, 7513 AB, Netherlands, 31 620946213, m.bults@saxion.nl %K type 2 diabetes %K self-management %K mobile health, mobile apps %K prevention %K mixed methods research %K acceptance %K mobile phone %D 2022 %7 27.1.2022 %9 Original Paper %J JMIR Diabetes %G English %X Background: Self-monitoring of blood glucose levels, food intake, and physical activity supports self-management of patients with type 2 diabetes mellitus (T2DM). There has been an increase in the development and availability of mobile health apps for T2DM. Objective: The aim of this study is to explore the actual use of mobile health apps for diabetes among patients with T2DM and the main barriers and drivers among app users and nonusers. Methods: An explanatory sequential design was applied, starting with a web-based questionnaire followed by semistructured in-depth interviews. Data were collected between July and December 2020. Questionnaire data from 103 respondents were analyzed using IBM SPSS Statistics (version 25.0). Descriptive statistics were performed for the actual use of apps and items of the Unified Theory of Acceptance and Use of Technology (UTAUT). The UTAUT includes 4 key constructs: performance expectancy (the belief that an app will help improve health performance), effort expectancy (level of ease associated with using an app), social influence (social support), and facilitating conditions (infrastructural support). Differences between users and nonusers were analyzed using chi-square tests for individual items. Independent 2-tailed t tests were performed to test for differences in mean scores per the UTAUT construct. In total, 16 respondents participated in the interviews (10 users and 6 nonusers of apps for T2DM). We performed content analysis using a deductive approach on all transcripts, guided by the UTAUT. Results: Regarding actual use, 55.3% (57/103) were nonusers and 44.7% (46/103) were users of apps for T2DM. The main driver for the use of apps was the belief that using apps for managing diabetes would result in better personal health and well-being. The time and energy required to keep track of the data and understand the app were mentioned as barriers. Mean scores were significantly higher among users compared with nonusers of apps for T2DM for the constructs performance expectancy (4.06, SD 0.64 vs 3.29, SD 0.89; P<.001), effort expectancy (4.04, SD 0.62 vs 3.50, SD 0.82; P<.001), social influence (3.59, SD 0.55 vs 3.29, SD 0.54; P=.007), and facilitating conditions (4.22, SD 0.48 vs 3.65, SD 0.70; P<.001). On the basis of 16 in-depth interviews, it was recognized that health care professionals play an important role in supporting patients with T2DM in using apps. However, respondents noticed that their health care professionals were often not supportive of the use of apps for managing diabetes, did not show interest, or did not talk about apps. Reimbursement by insurance companies was mentioned as a missing facilitator. Conclusions: Empowering health care professionals’ engagement is of utmost importance in supporting patients with T2DM in the use of apps. Insurance companies can play a role in facilitating the use of diabetes apps by ensuring reimbursement. %M 35084357 %R 10.2196/31451 %U https://diabetes.jmir.org/2022/1/e31451 %U https://doi.org/10.2196/31451 %U http://www.ncbi.nlm.nih.gov/pubmed/35084357 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 1 %P e32359 %T Gamified Web-Delivered Attentional Bias Modification Training for Adults With Chronic Pain: Protocol for a Randomized, Double-blind, Placebo-Controlled Trial %A Vermeir,Julie F %A White,Melanie J %A Johnson,Daniel %A Crombez,Geert %A Van Ryckeghem,Dimitri M L %+ School of Psychology and Counselling, Faculty of Health, Queensland University of Technology, 170 Victoria Park Road, Brisbane, 4059, Australia, 61 731384714, julie.vermeir@hdr.qut.edu.au %K chronic pain %K cognition %K attentional bias %K gamification %K motivation %K randomized controlled trial %K web-based intervention %K pain management %K digital intervention %K digital health %D 2022 %7 27.1.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: To date, research has found variable success in using attentional bias modification training (ABMT) procedures in pain samples. Several factors could contribute to these mixed findings, including boredom and low motivation. Indeed, training paradigms are repetitive, which can lead to disengagement and high dropout rates. A potential approach to overcoming some of these barriers is to attempt to increase motivation and engagement through gamification (ie, the use of game elements) of this procedure. To date, research has yet to explore the gamified format of ABMT for chronic pain and its potential for the transfer of benefits. Objective: The aim of this study is to investigate the effects of a gamified web-delivered ABMT intervention in a sample of adults with chronic pain via a randomized, double-blind, placebo-controlled trial. Methods: A total of 120 adults with chronic musculoskeletal pain, recruited from clinical (hospital outpatient waiting list) and nonclinical (wider community) settings, will be included in this randomized, double-blind, placebo-controlled, 3-arm trial. Participants will be randomly assigned to complete 6 web-based sessions of dot-probe nongamified sham control ABMT, nongamified standard ABMT, or gamified ABMT across a period of 3 weeks. Active ABMT conditions will aim to train attention away from pain-relevant words. Participant outcomes will be assessed at pretraining, during training, immediately after training, and at the 1-month follow-up. Primary outcomes include pain intensity, pain interference, and behavioral and self-reported engagement. Secondary outcomes include attentional bias for pain, anxiety, depression, interpretation bias for pain, and perceived improvement. Results: The ethical aspects of this research project have been approved by the human research ethics committees of the Royal Brisbane and Women’s Hospital (HREC/2020/QRBW/61743) and Queensland University of Technology (2000000395). Study recruitment commenced in August 2021 and is ongoing. Data collection and analysis are expected to be concluded by October 2022 and January 2023, respectively. Conclusions: This trial will be the first to evaluate the effects of gamification techniques in a pain ABMT intervention. The findings will provide important information on the potential therapeutic benefits of gamified pain ABMT programs, shed light on the motivational influences of certain game elements in the context of pain, and advance our understanding of chronic pain. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620000803998; https://anzctr.org.au/ACTRN12620000803998.aspx International Registered Report Identifier (IRRID): PRR1-10.2196/32359 %M 35084344 %R 10.2196/32359 %U https://www.researchprotocols.org/2022/1/e32359 %U https://doi.org/10.2196/32359 %U http://www.ncbi.nlm.nih.gov/pubmed/35084344 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 1 %P e32136 %T Effects of Acceptance and Commitment Therapy (ACT) on Mental Health and Resiliency of Migrant Live-in Caregivers in Canada: Pilot Randomized Wait List Controlled Trial %A Vahabi,Mandana %A Pui-Hing Wong,Josephine %A Moosapoor,Masoomeh %A Akbarian,Abdolreza %A Fung,Kenneth %+ Daphne Cockwell School of Nursing, Ryerson University, 350 Victoria Street, Toronto, ON, M5B 2K3, Canada, 1 416 979 5000 ext 552725, mvahabi@ryerson.ca %K migrant live-in caregiver %K women %K mental health %K acceptance and commitment therapy %K depression %K anxiety %K stress %K psychological inflexibility %K resilience %K social identity %D 2022 %7 27.1.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Temporary migrant live-in caregivers constitute a vulnerable stream of temporary foreign workers in Canada. This is because the majority are racialized women from the Global South, the gendered nature of caregiving work has historically been undervalued, and their working and living spheres are intertwined which makes application of labor laws and surveillance almost impossible. Their invisible position in the fabric of Canadian society along with their precarious employment and immigration status place their mental health at jeopardy. There is a paucity of research about psychological support for this population. Objective: Our pilot study Women Empowerment—Caregiver Acceptance and Resilience E-Learning (WE2CARE) aimed to assess the efficacy of a 6-week online delivery of a psychological intervention based on acceptance and commitment therapy (ACT) in reducing psychological distress and promoting resiliency among live-in care givers in the Greater Toronto Area. Methods: A pilot randomized wait list controlled design was used. Participants were recruited by two community peer champions working with community health organizations serving migrant live-in caregivers. A total of 36 participants were recruited and randomly assigned to the intervention and wait list control groups; 7 dropped out of the study due to competing life priorities. Standardized self-reported surveys were administered online pre-, post-, and 6-week postintervention to assess mental distress (DASS-21), psychological flexibility (AAQ-2), mindfulness (CAMS-R), and Multi-System Model of Resilience (MSMR-I). Independent and dependent t tests were used to compare study outcomes at pre, post, and 6-week follow-up across and within both arms of the study. Linear mixed effects models were created for each outcome of interest from baseline to postintervention among intervention and control participants. Self-reported impact of the WE2CARE intervention was examined using independent t tests across the study arms. Results: Average age of participants was 38 years. Many were born in the Philippines (23/29, 79%). The data on the impact of the psychological intervention showed a lower level of depression, anxiety, and stress among the intervention group compared with the control. However, the differences were not significant due to small sample size and COVID-19 crisis (6.94 vs 9.50, P=.54; 6.94 vs 10.83, P=.20; 7.76 vs 10.33, P=.44, respectively). There was a significant improvement in mindful qualities and external resilience, particularly in life satisfaction and accessible support among the intervention group (37.18 vs 32.92, t22=2.35, P=.03; 20.29 vs 16.5, t21=2.98, P=.007; 8.47 vs 6.75, t14=2.41, P=.03; 7.59 vs 5.33, t16=.008, respectively). Conclusions: WE2CARE is among the first studies exploring the efficacy of online delivery of ACT in addressing mental health challenges among live-in caregivers. While there are increased web-based ACT interventions, few use group videoconferencing to promote peer connection and mutual support. WE2CARE showed promising results in reducing psychological distress and promoting mindfulness and resiliency. The intervention highly motivated participants to engage collectively in building social support networks. International Registered Report Identifier (IRRID): RR2-10.2196/preprints.31211 %M 35084337 %R 10.2196/32136 %U https://formative.jmir.org/2022/1/e32136 %U https://doi.org/10.2196/32136 %U http://www.ncbi.nlm.nih.gov/pubmed/35084337 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e31754 %T Challenges of Telemonitoring Programs for Complex Chronic Conditions: Randomized Controlled Trial With an Embedded Qualitative Study %A Ware,Patrick %A Shah,Amika %A Ross,Heather Joan %A Logan,Alexander Gordon %A Segal,Phillip %A Cafazzo,Joseph Antony %A Szacun-Shimizu,Katarzyna %A Resnick,Myles %A Vattaparambil,Tessy %A Seto,Emily %+ Centre for Global eHealth Innovation, University Health Network, 190 Elizabeth St., Toronto, ON, M5G 2C4, Canada, 1 (416) 340 4800 ext 4765, Patrick.Ware@uhn.ca %K telemonitoring %K telemedicine %K heart failure %K diabetes %K hypertension %K tertiary health care %K multiple chronic conditions %K mobile phone %D 2022 %7 26.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite the growing prevalence of people with complex conditions and evidence of the positive impact of telemonitoring for single conditions, little research exists on telemonitoring for this population. Objective: This randomized controlled trial and embedded qualitative study aims to evaluate the impact on and experiences of patients and health care providers (HCPs) using a telemonitoring system with decision support to manage patients with complex conditions, including those with multiple chronic conditions, compared with the standard of care. Methods: A pragmatic, unblinded, 6-month randomized controlled trial sought to recruit 146 patients with ≥1 diagnosis of heart failure (HF), uncontrolled hypertension (HT), and insulin-requiring diabetes mellitus (DM) from outpatient specialty settings in Toronto, Ontario, Canada. Participants were randomized into the control and telemonitoring groups, with the latter being instructed to take readings relevant to their conditions. The telemonitoring system contained an algorithm that generated decision support in the form of actionable self-care directives to patients and alerts to HCPs. The primary outcome was health status (36-Item Short Form Health Survey questionnaire). Secondary outcomes included anxiety and depression, self-efficacy in chronic disease management, and self-reported health service use. HF-related quality of life and self-care measures were also collected from patients followed for HF. Within- and between-group change scores were analyzed for statistical significance (P<.05). A convenience sample of HCPs and patients in the intervention group was interviewed about their experiences. Results: A total of 96 patients were recruited and randomized. Recruitment was terminated early because of implementation challenges and the onset of the COVID-19 pandemic. No significant within- and between-group differences were found for the main primary and secondary outcomes. However, a within-group analysis of patients with HF found improvements in self-care maintenance (P=.04) and physical quality of life (P=.046). Opinions expressed by the 5 HCPs and 13 patients who were interviewed differed based on the monitored conditions. Although patients with HF reported benefitting from actionable self-care guidance and meaningful interactions with their HCPs, patient and HCP users of the DM and HT modules did not think telemonitoring improved the clinical management of those conditions to the same degree. These differing experiences were largely attributed to the siloed nature of specialty care and the design of the decision support, whereby fluctuations in the status of HT and DM typically required less urgent interventions compared with patients with HF. Conclusions: We recommend that future research conceive telemonitoring as a program and that self-management and clinical decision support are necessary but not sufficient components of such programs for patients with complex conditions and lower acuity. We conclude that telemonitoring for patients with complex conditions or within multidisciplinary care settings may be best operationalized through nurse-led models of care. Trial Registration: ClinicalTrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852 International Registered Report Identifier (IRRID): RR2-10.2196/resprot.8367 %M 35080502 %R 10.2196/31754 %U https://www.jmir.org/2022/1/e31754 %U https://doi.org/10.2196/31754 %U http://www.ncbi.nlm.nih.gov/pubmed/35080502 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e30566 %T The Effectiveness of Sequentially Delivered Web-Based Interventions on Promoting Physical Activity and Fruit-Vegetable Consumption Among Chinese College Students: Mixed Methods Study %A Duan,Yanping %A Liang,Wei %A Wang,Yanping %A Lippke,Sonia %A Lin,Zhihua %A Shang,Borui %A Baker,Julien Steven %+ Department of Sport, Physical Education and Health, Faculty of Social Sciences, Hong Kong Baptist University, 12/F Hong Kong Baptist University Shek Mun Campus, 8 On Muk Street, Shek Mun, Shatin, Hong Kong, HKG, China (Hong Kong), 852 34113038, duanyp@hkbu.edu.hk %K web-based intervention %K physical activity %K fruit-vegetable consumption %K college students %K health action process approach %K mixed methods %K quantitative research %K qualitative research %D 2022 %7 26.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based interventions for multiple health behavior change (MHBC) appear to be a promising approach to change unhealthy habits. Limited research has tested this assumption in promoting physical activity (PA) and fruit-vegetable consumption (FVC) among Chinese college students. Moreover, the timing of MHBC intervention delivery and the order of components need to be addressed. Objective: This study aims to examine the effectiveness of 2 sequentially delivered 8-week web-based interventions on physical activity, FVC, and health-related outcomes (BMI, depression, and quality of life) and the differences in the intervention effects between the 2 sequential delivery patterns. The study also aims to explore participants’ experiences of participating in the health program. Methods: We conducted a randomized controlled trial, in which 552 eligible college students (mean 19.99, SD 1.04 years, 322/552, 58.3% female) were randomly assigned to 1 of 3 groups: PA-first group (4 weeks of PA followed by 4 weeks of FVC intervention), FVC-first group (4 weeks of FVC followed by 4 weeks of PA intervention), and a control group (8 weeks of placebo treatment unrelated to PA and FVC). The treatment content of two intervention groups was designed based on the Health Action Process Approach (HAPA) framework. A total of four web-based assessments were conducted: at baseline (T1, n=565), after 4 weeks (T2, after the first behavior intervention, n=486), after 8 weeks (T3, after the second behavior intervention, n=420), and after 12 weeks (T4, 1-month postintervention follow-up, n=348). In addition, after the completion of the entire 8-week intervention, 18 participants (mean 19.56, SD 1.04 years, 10/18, 56% female) who completed the whole program were immediately invited to attend one-to-one and face-to-face semistructured interviews. The entire study was conducted during the fall semester of 2017. Results: The quantitative data supported superior effects on physical activity, FVC, and BMI in the 2 sequential intervention groups compared with the control group. There were no significant differences in physical activity, FVC, and health-related outcomes between the 2 intervention groups after 8 weeks. The FVC-first group contributed to more maintenance of FVC compared with the PA-first group after 12 weeks. Four major themes with several subthemes were identified in the qualitative thematic analysis: PA and FVC behavior, health-related outcomes, correlates of behavior change, and contamination detection. Conclusions: This study provides empirical evidence for the effectiveness of sequentially delivered, web-based MHBC interventions on PA and FVC among Chinese college students. The timing issue of MHBC intervention delivery was preliminarily addressed. Qualitative findings provide an in-depth understanding and supplement the quantitative findings. Overall, this study may contribute considerably to future web-based MHBC interventions. Trial Registration: ClinicalTrials.gov NCT03627949; https://clinicaltrials.gov/ct2/show/NCT03627949 International Registered Report Identifier (IRRID): RR2-10.1186/s12889-019-7438-1 %M 35080497 %R 10.2196/30566 %U https://www.jmir.org/2022/1/e30566 %U https://doi.org/10.2196/30566 %U http://www.ncbi.nlm.nih.gov/pubmed/35080497 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 1 %P e34033 %T Randomized Waitlist-Control Trial of a Web-Based Stress-Management and Resiliency Program for Adolescent and Young Adult Cancer Survivors: Protocol for the Bounce Back Study %A Mizrach,Helen %A Goshe,Brett %A Park,Elyse R %A Recklitis,Christopher %A Greer,Joseph A %A Chang,Yuchiao %A Frederick,Natasha %A Abrams,Annah %A Tower,Mary D %A Walsh,Emily A %A Huang,Mary %A Kenney,Lisa %A Homans,Alan %A Miller,Karen %A Denninger,John %A Usmani,Ghazala Naheed %A Peppercorn,Jeffrey %A Perez,Giselle K %+ Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, United States, 1 9084992113, hmizrach@mgh.harvard.edu %K cancer survivorship %K adolescent and young adult (AYA) %K resiliency %K stress management %K coping %D 2022 %7 26.1.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: The emotional health of adolescent and young adult (AYA) cancer survivors is compromised both during and after cancer treatment. Targeted programs designed to support AYAs’ ability to cope with stress in the years following treatment completion are lacking. Mind-body programs may ameliorate the negative psychological and emotional effects of stress and assist AYAs with managing the psychosocial challenges of early survivorship. Objective: Our randomized waitlist-control trial aims to assess the feasibility, acceptability, and preliminary efficacy of a virtual group program (Bounce Back) to promote stress management and resiliency among posttreatment AYAs. Methods: Bounce Back is a stress management and resiliency program delivered via videoconference by a trained mental health clinician. Sessions were adapted from an evidence-based mind-body program (Stress Management and Resiliency Training - Relaxation Response Resiliency Program [SMART-3RP]) grounded in relaxation response elicitation, mindfulness, cognitive behavioral therapy, and positive psychology. Seventy-two AYAs (diagnosed with cancer between ages 14 years and 29 years and had completed cancer treatment within the last 5 years) were randomly assigned to the Bounce Back program or waitlist-control group and completed assessments at baseline, 3 months postbaseline, and 6 months postbaseline. The primary aim of the study is to determine the feasibility and acceptability of the Bounce Back program. Descriptive statistics, including means, frequencies, and ranges supplemented by qualitative exit interview feedback will be used to characterize the sample and to summarize feasibility and acceptability. The exploratory aims are to evaluate the preliminary effects of the program on stress coping and psychosocial outcome measures (ie, anxiety, depression) collected across the 3 time points. Results: This study was funded by the National Cancer Institute in July 2017. Study procedures were approved by the Dana-Farber Harvard Cancer Center Institutional Review Board in October 2018 (Protocol 18-428). The randomized trial was conducted from July 2019 to March 2021. Quantitative data collection is complete, and qualitative exit interview data collection is ongoing. Results are expected to be published in peer-reviewed journals and presented at local, national, or international meetings in the coming years. Conclusions: Few evidence-based programs exist that tackle the key transitional issues faced by AYA cancer survivors. Future analyses will help us determine the feasibility and acceptability of the Bounce Back program and its impact on AYA stress coping and psychological well-being. Trial Registration: ClinicalTrials.gov NCT03768336; https://clinicaltrials.gov/ct2/show/NCT03768336 International Registered Report Identifier (IRRID): DERR1-10.2196/34033 %M 35080500 %R 10.2196/34033 %U https://www.researchprotocols.org/2022/1/e34033 %U https://doi.org/10.2196/34033 %U http://www.ncbi.nlm.nih.gov/pubmed/35080500 %0 Journal Article %@ 2562-7600 %I JMIR Publications %V 5 %N 1 %P e31380 %T Web-Based Training for Nurses on Using a Decision Aid to Support Shared Decision-making About Prenatal Screening: Parallel Controlled Trial %A Poulin Herron,Alex %A Agbadje,Titilayo Tatiana %A Guay-Bélanger,Sabrina %A Ngueta,Gérard %A Roch,Geneviève %A Rousseau,François %A Légaré,France %+ VITAM - Research Center on Sustainable Health, Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale, 2480, chemin de la Canardière, Quebec City, QC, G1G 2G1, Canada, 1 418 663 5313 ext 12286, France.Legare@mfa.ulaval.ca %K shared decision-making %K prenatal screening %K training %K nurses %K nursing %K behavioral intention %K trisomy %K Down syndrome %K continuing professional development %K continuing education %K medical education %K decision aid %K screening %K prenatal %K pediatrics %D 2022 %7 25.1.2022 %9 Original Paper %J JMIR Nursing %G English %X Background: Nurses play an important role in supporting pregnant women making decisions about prenatal screening for Down syndrome. We developed a web-based shared decision-making (SDM) training program for health professionals focusing on Down syndrome screening decisions. Objective: In this study, we aim to assess the impact of an SDM training program on nurses’ intention to use a decision aid with pregnant women deciding on prenatal screening for Down syndrome. Methods: In this 2-arm, parallel controlled trial, French-speaking nurses working with pregnant women in the province of Quebec were recruited by a private survey firm. They were allocated by convenience either to the intervention group (web-based SDM course that included prenatal screening) or to the control group (web-based course focusing on prenatal screening alone, with no SDM content). The primary outcome was the intention to use a decision aid. Secondary outcomes were psychosocial variables of intention, knowledge, satisfaction, acceptability, perceived usefulness, and reaction to the pedagogical approach. All outcomes were self-assessed through web-based questionnaires, including the space for written comments. We used 2-tailed Student t test and Fisher exact test to compare continuous and categorical variables between groups, respectively. Results: Of the 57 participants assessed for eligibility, 40 (70%) were allocated to the intervention (n=20) or control group (n=20) and 36 (n=18 in each) completed the courses. The mean age of the participants was 41 (SD 9) years. Most were women (39/40, 98%), White (38/40, 95%), clinical nurses (28/40, 70%), and had completed at least a bachelor’s degree (30/40, 75%). After the intervention, the mean score of intention was 6.3 (SD 0.8; 95% CI 5.9-6.7) for the intervention group and 6.0 (SD 1.2; 95% CI 5.42-6.64) for the control group (scale 1-7). The differences in intention and other psychosocial variable scores between the groups were not statistically significant. Knowledge scores for SDM were significantly higher in the intervention group (79%, 95% CI 70-89 vs 64%, 95% CI 57-71; P=.009). The intervention was significantly more acceptable in the intervention group (4.6, 95% CI 4.4-4.8 vs 4.3, 95% CI 4.1-4.5; P=.02), and reaction to the pedagogical approach was also significantly more positive in the intervention group (4.7, 95% CI 4.5-4.8 vs 4.4, 95% CI 4.2-4.5; P=.02). There was no significant difference in overall satisfaction (or in perceived usefulness). Furthermore, 17 participants (9 in the intervention group and 8 in the control group) provided written comments on the intervention. Conclusions: This study focuses on web-based nursing education and its potential to support pregnant women’s decision-making needs. It shows that nurses’ intention to use a decision aid to enhance SDM in prenatal care is high, with or without training, but that their knowledge about SDM can be improved with web-based training. International Registered Report Identifier (IRRID): RR2-10.2196/17878 %M 34874274 %R 10.2196/31380 %U https://nursing.jmir.org/2022/1/e31380 %U https://doi.org/10.2196/31380 %U http://www.ncbi.nlm.nih.gov/pubmed/34874274 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 1 %P e33798 %T Active Use and Engagement in an mHealth Initiative Among Young Men With Obesity: Mixed Methods Study %A Gorny,Alexander Wilhelm %A Chee,Wei Chian Douglas %A Müller-Riemenschneider,Falk %+ Centre of Excellence for Soldier Performance, Singapore Armed Forces, Pasir Laba Camp, Blk 130 #03-09, Singapore, 637901, Singapore, 65 81337238, alexander_gorny@u.nus.edu %K mHealth %K physical activity %K health promoting financial incentives %K weight loss maintenance %K young men %D 2022 %7 25.1.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The effectiveness of mobile health (mHealth) approaches that employ wearable technology to promote physical activity have been the subject of concern due to the declining active use observed in trial settings. Objective: To better contextualize active use, this study aimed to identify the barriers and enablers to engagement in a tracker-based mHealth initiative among young men who had recently completed a 19-week residential weight loss program. Methods: A mixed methods study was conducted among 167 young men who had voluntarily enrolled in the national steps challenge (NSC), an mHealth physical activity promotion initiative, following a residential weight loss intervention. A subsample of 29 enrollees with a body mass index of 29.6 (SD 3.1) participated in semistructured interviews and additional follow-up assessments. Quantitative systems data on daily step count rates were used to describe active use. Qualitative data were coded and analyzed to elicit barriers and enablers to microlevel engagement in relation to the NSC, focusing on tracker and smartphone use. We further elicited barriers and enablers to macrolevel engagement by exploring attitudes and behaviors toward the NSC. Using triangulation, we examined how qualitative engagement in the NSC could account for quantitative findings on active use. Using integration of findings, we discussed how the mHealth intervention might have changed physical activity behavior. Results: Among the 167 original enrollees, active use declined from 72 (47%) in week 1 to 27 (17%) in week 21. Mean daily step counts peaked in week 1 at 10,576 steps per day and were variable throughout the NSC. Barriers to engagement had occurred in the form of technical issues leading to abandonment, device switching, and offline tracking. Passive attitudes toward step counting and disinterest in the rewards had also prevented deeper engagement. Enablers of engagement included self-monitoring and coaching features, while system targets and the implicit prospect of reward had fostered new physical activity behaviors. Conclusions: Our study showed that as the NSC is implemented in this population, more emphasis should be placed on technical support and personalized activity targets to promote lasting behavior change. %M 35076399 %R 10.2196/33798 %U https://formative.jmir.org/2022/1/e33798 %U https://doi.org/10.2196/33798 %U http://www.ncbi.nlm.nih.gov/pubmed/35076399 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e33631 %T Effectiveness of Internet-Based Cognitive Behavioral Therapy With Telephone Support for Noncardiac Chest Pain: Randomized Controlled Trial %A Thesen,Terje %A Himle,Joseph A %A Martinsen,Egil W %A Walseth,Liv T %A Thorup,Frode %A Gallefoss,Frode %A Jonsbu,Egil %+ Distriktspsykiatrisk senter Solvang, Sørlandet Hospital, Sørlandet sykehus Helse Foretak, Servicebox 416, Kristiansand, 4604, Norway, 47 38174800, terje.thesen@sshf.no %K noncardiac chest pain %K internet-based treatment %K internet-assisted treatment %K cognitive behavioral therapy %K psychosomatic medicine %K randomized controlled trial %K pain %K treatment %K internet-based cognitive behavioral therapy %K effectiveness %K support %K intervention %D 2022 %7 24.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Noncardiac chest pain has a high prevalence and is associated with reduced quality of life, anxiety, avoidance of physical activity, and high societal costs. There is a lack of an effective, low-cost, easy to distribute intervention to assist patients with noncardiac chest pain. Objective: In this study, we aimed to investigate the effectiveness of internet-based cognitive behavioral therapy with telephone support for noncardiac chest pain. Methods: We conducted a randomized controlled trial, with a 12-month follow-up period, to compare internet-based cognitive behavioral therapy to a control condition (treatment as usual). A total of 162 participants aged 18 to 70 years with a diagnosis of noncardiac chest pain were randomized to either internet-based cognitive behavioral therapy (n=81) or treatment as usual (n=81). The participants in the experimental condition received 6 weekly sessions of internet-based cognitive behavioral therapy. The sessions covered different topics related to coping with noncardiac chest pain (education about the heart, physical activity, interpretations/attention, physical reactions to stress, optional panic treatment, and maintaining change). Between sessions, the participants also engaged in individually tailored physical exercises with increasing intensity. In addition to internet-based cognitive behavioral therapy sessions, participants received a brief weekly call from a clinician to provide support, encourage adherence, and provide access to the next session. Participants in the treatment-as-usual group received standard care for their noncardiac chest pain without any restrictions. Primary outcomes were cardiac anxiety, measured with the Cardiac Anxiety Questionnaire, and fear of bodily sensations, measured with the Body Sensations Questionnaire. Secondary outcomes were depression, measured using the Patient Health Questionnaire; health-related quality of life, measured using the EuroQol visual analog scale; and level of physical activity, assessed with self-report question. Additionally, a subgroup analysis of participants with depressive symptoms at baseline (PHQ-9 score ≥5) was conducted. Assessments were conducted at baseline, posttreatment, and at 3- and 12-month follow-ups. Linear mixed models were used to evaluate treatment effects. Cohen d was used to calculate effect sizes. Results: In the main intention-to-treat analysis at the 12-month follow-up time point, participants in the internet-based cognitive behavioral therapy group had significant improvements in cardiac anxiety (–3.4 points, 95% CI –5.7 to –1.1; P=.004, d=0.38) and a nonsignificant improvement in fear of bodily sensations (–2.7 points, 95% CI –5.6 to 0.3; P=.07) compared with the treatment-as-usual group. Health-related quality of life at the 12-month follow-up improved with statistical and clinical significance in the internet-based cognitive behavioral therapy group (8.8 points, 95% CI 2.8 to 14.8; P=.004, d=0.48) compared with the treatment-as-usual group. Physical activity had significantly (P<.001) increased during the 6-week intervention period for the internet-based cognitive behavioral therapy group. Depression significantly improved posttreatment (P=.003) and at the 3-month follow-up (P=.03), but not at the 12-month follow-up (P=.35). Participants with depressive symptoms at baseline seemed to have increased effect of the intervention on cardiac anxiety (d=0.55) and health-related quality of life (d=0.71) at the 12-month follow-up. In the internet-based cognitive behavioral therapy group, 84% of the participants (68/81) completed at least 5 of the 6 sessions. Conclusions: This study provides evidence that internet-based cognitive behavioral therapy with minimal therapist contact and a focus on physical activity is effective in reducing cardiac anxiety and increasing health related quality of life in patients with noncardiac chest pain. Trial Registration: ClinicalTrials.gov NCT03096925; http://clinicaltrials.gov/ct2/show/NCT03096925 %M 35072641 %R 10.2196/33631 %U https://www.jmir.org/2022/1/e33631 %U https://doi.org/10.2196/33631 %U http://www.ncbi.nlm.nih.gov/pubmed/35072641 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e26555 %T Using Intervention Mapping to Develop a Decision Support System–Based Smartphone App (selfBACK) to Support Self-management of Nonspecific Low Back Pain: Development and Usability Study %A Svendsen,Malene Jagd %A Sandal,Louise Fleng %A Kjær,Per %A Nicholl,Barbara I %A Cooper,Kay %A Mair,Frances %A Hartvigsen,Jan %A Stochkendahl,Mette Jensen %A Søgaard,Karen %A Mork,Paul Jarle %A Rasmussen,Charlotte %+ The National Research Centre for the Working Environment, Lersø Parkallé 105, Copenhagen, 2100, Denmark, 45 20259734, mas@nfa.dk %K intervention mapping %K behavior change %K low back pain %K self-management %K mHealth %K app-based intervention %K decision support system %K digital health intervention %K mobile phone %D 2022 %7 24.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: International guidelines consistently endorse the promotion of self-management for people with low back pain (LBP); however, implementation of these guidelines remains a challenge. Digital health interventions, such as those that can be provided by smartphone apps, have been proposed as a promising mode of supporting self-management in people with chronic conditions, including LBP. However, the evidence base for digital health interventions to support self-management of LBP is weak, and detailed descriptions and documentation of the interventions are lacking. Structured intervention mapping (IM) constitutes a 6-step process that can be used to guide the development of complex interventions. Objective: The aim of this paper is to describe the IM process for designing and creating an app-based intervention designed to support self-management of nonspecific LBP to reduce pain-related disability. Methods: The first 5 steps of the IM process were systematically applied. The core processes included literature reviews, brainstorming and group discussions, and the inclusion of stakeholders and representatives from the target population. Over a period of >2 years, the intervention content and the technical features of delivery were created, tested, and revised through user tests, feasibility studies, and a pilot study. Results: A behavioral outcome was identified as a proxy for reaching the overall program goal, that is, increased use of evidence-based self-management strategies. Physical exercises, education, and physical activity were the main components of the self-management intervention and were designed and produced to be delivered via a smartphone app. All intervention content was theoretically underpinned by the behavior change theory and the normalization process theory. Conclusions: We describe a detailed example of the application of the IM approach for the development of a theory-driven, complex, and digital intervention designed to support self-management of LBP. This description provides transparency in the developmental process of the intervention and can be a possible blueprint for designing and creating future digital health interventions for self-management. %M 35072645 %R 10.2196/26555 %U https://www.jmir.org/2022/1/e26555 %U https://doi.org/10.2196/26555 %U http://www.ncbi.nlm.nih.gov/pubmed/35072645 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 9 %N 1 %P e29008 %T Effectiveness, User Engagement and Experience, and Safety of a Mobile App (Lumi Nova) Delivering Exposure-Based Cognitive Behavioral Therapy Strategies to Manage Anxiety in Children via Immersive Gaming Technology: Preliminary Evaluation Study %A Lockwood,Joanna %A Williams,Laura %A Martin,Jennifer L %A Rathee,Manjul %A Hill,Claire %+ National Institute of Health Research MindTech MedTech Co-operative, School of Medicine, University of Nottingham, Institute of Mental Health, Jubilee Campus, Triumph Road, Nottingham, NG7 2TU, United Kingdom, 44 115 8231294, joanna.lockwood@nottingham.ac.uk %K anxiety %K children %K exposure therapy %K cognitive behavioral therapy %K immersive gaming %K digital intervention %K app %K smartphone %K mobile phone %D 2022 %7 24.1.2022 %9 Original Paper %J JMIR Ment Health %G English %X Background: Childhood anxiety disorders are a prevalent mental health problem that can be treated effectively with cognitive behavioral therapy, in which exposure is a key component; however, access to treatment is poor. Mobile-based apps on smartphones or tablets may facilitate the delivery of evidence-based therapy for child anxiety, thereby overcoming the access and engagement barriers of traditional treatment. Apps that deliver therapeutic content via immersive gaming technology could offer an effective, highly engaging, and flexible treatment proposition. Objective: In this paper, we aim to describe a preliminary multi-method evaluation of Lumi Nova, a mobile app intervention targeting mild to moderate anxiety problems in children aged 7-12 years using exposure therapy delivered via an immersive game. The primary objective is to evaluate the effectiveness, user engagement and experience, and safety of the beta version of Lumi Nova. Methods: Lumi Nova was co-designed with children, parents, teachers, clinicians, game industry experts, and academic partnerships. In total, 120 community-based children with mild to moderate anxiety and their guardians were enrolled to participate in an 8-week pilot study. The outcome measures captured the app’s effectiveness (anxiety symptoms, child-identified goal-based outcomes, and functional impairment), user engagement (game play data and ease-of-use ratings), and safety (mood ratings and adverse events). The outcome measures before and after the intervention were available for 30 children (age: mean 9.8, SD 1.7 years; girls: 18/30, 60%; White: 24/30, 80%). Additional game play data were automatically generated for 67 children (age: mean 9.6, SD 1.53 years; girls: 35/67, 52%; White: 42/67, 63%). Postintervention open-response data from 53% (16/30) of guardians relating to the primary objectives were also examined. Results: Playing Lumi Nova was effective in reducing anxiety symptom severity over the 8-week period of game play (t29=2.79; P=.009; Cohen d=0.35) and making progress toward treatment goals (z=2.43; P=.02), but there were no improvements in relation to functional impairment. Children found it easy to play the game and engaged safely with therapeutic content. However, the positive effects were small, and there were limitations to the game play data. Conclusions: This preliminary study provides initial evidence that an immersive mobile game app may safely benefit children experiencing mild to moderate anxiety. It also demonstrates the value of the rigorous evaluation of digital interventions during the development process to rapidly improve readiness for full market launch. %M 35072644 %R 10.2196/29008 %U https://mental.jmir.org/2022/1/e29008 %U https://doi.org/10.2196/29008 %U http://www.ncbi.nlm.nih.gov/pubmed/35072644 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 10 %N 1 %P e32400 %T Evaluation of an AIDS Educational Mobile Game (AIDS Fighter · Health Defense) for Young Students to Improve AIDS-Related Knowledge, Stigma, and Attitude Linked to High-Risk Behaviors in China: Randomized Controlled Trial %A Tang,Jian %A Zheng,Yu %A Zhang,Daiying %A Yu,Xingli %A Ren,Jianlan %A Li,Mei %A Luo,Yue %A Tian,Min %A Chen,Yanhua %+ Department of Nursing, The Affiliated Hospital of Southwest Medical University, 25 Taiping Street, Jiangyang District, Luzhou, 646000, China, 86 18982765016, chen_yanhua25@163.com %K young students %K AIDS education %K educational game %K game-based intervention %K serious games %K public health %K HIV %K AIDS epidemic %K stigma %K health defense %K health knowledge %K digital health %K digital health intervention %D 2022 %7 24.1.2022 %9 Original Paper %J JMIR Serious Games %G English %X Background: The AIDS epidemic among young students is serious, and effective preventive interventions are urgently needed. Game-based intervention has become an innovative way to change healthy behaviors, and we have developed an AIDS educational game called AIDS Fighter · Health Defense. Objective: In this study, we tested the effect of AIDS Fighter · Health Defense on young students in improving AIDS-related knowledge, stigma, and attitude related to high-risk behaviors in Southwest China. Methods: A randomized controlled trial was conducted from September 14 to 27, 2020. In total, 96 students from 2 classes in a middle school were selected by stratified cluster sampling in Luzhou City, Southwest China. The students were randomly divided into the intervention group (n=50, 52%) and the control group (n=46, 48%). The intervention group played the AIDS educational game AIDS Fighter · Health Defense; the control group learned AIDS-related knowledge through independent learning on the QQ chat group. An AIDS-related knowledge questionnaire, a stigma scale, and an attitude questionnaire on AIDS-related high-risk behaviors were used to measure the effect of the AIDS educational game via face-to-face interviews. The user experience of the game was assessed using the Educational Game User Experience Evaluation Scale. The difference was statistically significant at P≤.05. Results: After the intervention, the AIDS knowledge awareness rate (X̅ [SD], %) of the intervention and control groups were 70.09 (SD 11.58) and 57.49 (SD 16.58), with t=4.282 and P<.001. The stigma scores of the 2 groups were 2.44 (SD 0.57) and 2.48 (SD 0.47), with t=0.373 and P=0.71. The positive rate (X̅ [SD], %) of attitudes of high-risk AIDS behaviors of the 2 groups were 82.00 (SD 23.44) and 79.62 (SD 17.94), with t=0.555 and P=0.58. The mean percentage of the game evaluation was 54.73% as excellent, 31.45% as good, 13.09% as medium, and 0.73% as poor. Conclusions: AIDS Fighter · Health Defense could increase AIDS-related knowledge among young students, but the effect of the game in reducing AIDS-related stigma and improving the attitudes of high-risk AIDS behaviors was not seen. Long-term effects and large-scale studies are needed to assess the efficacy of game-based intervention. Trial Registration: Chinese Clinical Trial Registry ChiCTR2000038230; https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2000038230 %M 34870603 %R 10.2196/32400 %U https://games.jmir.org/2022/1/e32400 %U https://doi.org/10.2196/32400 %U http://www.ncbi.nlm.nih.gov/pubmed/34870603 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e31935 %T The Relative Contributions of Live and Recorded Online Mindfulness Training Programs to Lower Stress in the Workplace: Longitudinal Observational Study %A Wolever,Ruth Q %A Finn,Michael T M %A Shields,Denise %+ Osher Center for Integrative Health at Vanderbilt, Department of Physical Medicine & Rehabilitation, Vanderbilt University School of Medicine, 3401 West End Ave, Suite 380, Nashville, TN, 37203, United States, 1 919 622 2819, ruth.wolever@vumc.org %K mindfulness %K live versus recorded %K synchronous %K asynchronous %K workplace %K digital health %K online %K live teaching %K contribution %K training %K stress %K longitudinal %K observational %K platform %K eHealth %K mental health %D 2022 %7 21.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite numerous gaps in the literature, mindfulness training in the workplace is rapidly proliferating. Many “online” or “digital mindfulness” programs do not distinguish between live teaching and recorded or asynchronous sessions, yet differences in delivery mode (eg, face-to-face, online live, online self-guided, other) may explain outcomes. Objective: The aim of this study was to use existing data from an online mindfulness solutions company to assess the relative contribution of live and recorded mindfulness training to lower perceived stress in employees. Methods: Perceived stress and the amount of live and recorded online mindfulness training accessed by employees were assessed during eMindful’s One-Percent Challenge (OPC). The OPC is a 30-day program wherein participants are encouraged to spend 1% of their day (14 minutes) practicing mindfulness meditation on the platform. We used linear mixed-effects models to assess the relationship between stress reduction and usage of components of the eMindful platform (live teaching and recorded options) while controlling for potential reporting bias (completion) and sampling bias. Results: A total of 8341 participants from 44 companies registered for the OPC, with 7757 (93.00%) completing stress assessments prior to the OPC and 2360 (28.29%) completing the postassessment. Approximately one-quarter of the participants (28.86%, 2407/8341) completed both assessments. Most of the completers (2161/2407, 89.78%) engaged in the platform at least once. Among all participants (N=8341), 8.78% (n=707) accessed only recorded sessions and 33.78% (n=2818) participated only in the live programs. Most participants engaged in both live and recorded options, with those who used any recordings (2686/8341, 32.20%) tending to use them 3-4 times. Controlling for completer status, any participation with the eMindful OPC reduced stress (B=–0.32, 95% CI –0.35 to –0.30, SE=0.01, t2393.25=–24.99, P<.001, Cohen d=–1.02). Participation in live programs drove the decrease in stress (B=–0.03, SE=0.01, t3258.61=–3.03, P=.002, d=–0.11), whereas participation in recorded classes alone did not. Regular practice across the month led to a greater reduction in stress. Conclusions: Our findings are in stark contrast to the rapid evolution of online mindfulness training for the workplace. While the market is reproducing apps and recorded teaching at an unprecedented pace, our results demonstrate that live mindfulness programs with recorded or on-demand programs used to supplement live practices confer the strongest likelihood of achieving a significant decrease in stress levels. %M 35060911 %R 10.2196/31935 %U https://www.jmir.org/2022/1/e31935 %U https://doi.org/10.2196/31935 %U http://www.ncbi.nlm.nih.gov/pubmed/35060911 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 1 %P e32211 %T A Virtual Coach (Motibot) for Supporting Healthy Coping Strategies Among Adults With Diabetes: Proof-of-Concept Study %A Bassi,Giulia %A Giuliano,Claudio %A Perinelli,Alessio %A Forti,Stefano %A Gabrielli,Silvia %A Salcuni,Silvia %+ Department of Developmental and Socialization Psychology, University of Padova, Via Venezia 8, Padova, 35131, Italy, 39 3477334405, giulia.bassi@phd.unipd.it %K virtual coach %K diabetes mellitus %K adults %K psychosocial factors %K mindfulness %K proof-of-concept study %K mobile phone %D 2022 %7 21.1.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Motivation is a core component of diabetes self-management because it allows adults with diabetes mellitus (DM) to adhere to clinical recommendations. In this context, virtual coaches (VCs) have assumed a central role in supporting and treating common barriers related to adherence. However, most of them are mainly focused on medical and physical purposes, such as the monitoring of blood glucose levels or following a healthy diet. Objective: This proof-of-concept study aims to evaluate the preliminary efficacy of a VC intervention for psychosocial support before and after the intervention and at follow-up. The intent of this VC is to motivate adults with type 1 DM and type 2 DM to adopt and cultivate healthy coping strategies to reduce symptoms of depression, anxiety, perceived stress, and diabetes-related emotional distress, while also improving their well-being. Methods: A total of 13 Italian adults with DM (18-51 years) interacted with a VC, called Motibot (motivational bot) using the Telegram messaging app. The interaction covered 12 sessions, each lasting 10 to 20 minutes, during which the user could dialogue with the VC by inputting text or tapping an option on their smartphone screen. Motibot is developed within the transtheoretical model of change to deliver the most appropriate psychoeducational intervention based on the user’s motivation to change. Results: Results showed that over the 12 sessions, there were no significant changes before and after the intervention and at follow-up regarding psychosocial factors. However, most users showed a downward trend over the 3 time periods in depression and anxiety symptoms, thereby presenting good psychological well-being and no diabetes-related emotional distress. In addition, users felt motivated, involved, encouraged, emotionally understood, and stimulated by Motibot during the interaction. Indeed, the analyses of semistructured interviews, using a text mining approach, showed that most users reported a perceived reduction in anxiety, depression, and/or stress symptoms. Moreover, users indicated the usefulness of Motibot in supporting and motivating them to find a mindful moment for themselves and to reflect on their own emotions. Conclusions: Motibot was well accepted by users, particularly because of the inclusion of mindfulness practices, which motivated them to adopt healthy coping skills. To this extent, Motibot provided psychosocial support for adults with DM, particularly for those with mild and moderate symptoms, whereas those with severe symptoms may benefit more from face-to-face psychotherapy. %M 35060918 %R 10.2196/32211 %U https://humanfactors.jmir.org/2022/1/e32211 %U https://doi.org/10.2196/32211 %U http://www.ncbi.nlm.nih.gov/pubmed/35060918 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 1 %P e33449 %T An Acceptance and Commitment Therapy Prototype Mobile Program for Individuals With a Visible Difference: Mixed Methods Feasibility Study %A Zucchelli,Fabio %A Donnelly,Olivia %A Rush,Emma %A White,Paul %A Gwyther,Holly %A Williamson,Heidi %A , %+ Health and Applied Sciences, University of the West of England, Frenchay Campus, Bristol, BS16 1QY, United Kingdom, 44 7816449143, fabio.zucchelli@uwe.ac.uk %K mobile health %K acceptance and commitment therapy %K appearance %K mixed methods %K mobile phone %D 2022 %7 21.1.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Mobile apps may offer a valuable platform for delivering evidence-based psychological interventions for individuals with atypical appearances, or visible differences, who experience psychosocial appearance concerns such as appearance-based social anxiety and body dissatisfaction. Before this study, researchers and stakeholders collaboratively designed an app prototype based on acceptance and commitment therapy (ACT), an evidence-based form of cognitive behavioral therapy that uses strategies such as mindfulness, clarification of personal values, and value-based goal setting. The intervention also included social skills training, an established approach for increasing individuals’ confidence in managing social interactions, which evoke appearance-based anxiety for many. Objective: In this study, the authors aim to evaluate the feasibility of an ACT-based app prototype via the primary objectives of user engagement and acceptability and the secondary feasibility objective of clinical safety and preliminary effectiveness. Methods: To address the feasibility objectives, the authors used a single-group intervention design with mixed methods in a group of 36 participants who have a range of visible differences. The authors collected quantitative data via measures of program use, satisfaction ratings, and changes over 3 time points spanning 12 weeks in outcomes, including selected ACT process measures (experiential avoidance, cognitive defusion, and valued action), scales of appearance concerns (appearance-based life disengagement, appearance-fixing behaviors, appearance self-evaluation, and fear of negative appearance evaluation), and clinical well-being (depression and anxiety). Semistructured exit interviews with a subsample of 12 participants provided qualitative data to give a more in-depth understanding of participants’ views and experiences of the program. Results: In terms of user engagement, adherence rates over 6 sessions aligned with the upper boundary of those reported across mobile mental health apps, with over one-third of participants completing all sessions over 12 weeks, during which a steady decline in adherence was observed. Time spent on sessions matched design intentions, and engagement frequencies highlighted semiregular mindfulness practice, mixed use of value-based goal setting, and high engagement with social skills training. The findings indicate a good overall level of program acceptability via satisfaction ratings, and qualitative interview findings offer positive feedback as well as valuable directions for revisions. Overall, testing for clinical safety and potential effectiveness showed encouraging changes over time, including favorable changes in appearance-related life disengagement, appearance-fixing behaviors, and selected ACT measures. No iatrogenic effects were indicated for depression or anxiety. Conclusions: An ACT-based mobile program for individuals struggling with visible differences shows promising proof of concept in addressing appearance concerns, although further revisions and development are required before further development and more rigorous evaluation. %M 35060908 %R 10.2196/33449 %U https://formative.jmir.org/2022/1/e33449 %U https://doi.org/10.2196/33449 %U http://www.ncbi.nlm.nih.gov/pubmed/35060908 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 1 %P e34546 %T Outcomes Following eHealth Weight Management Interventions in Adults With Overweight and Obesity From Low Socioeconomic Groups: Protocol for a Systematic Review %A Myers-Ingram,Richard %A Sampford,Jade %A Milton-Cole,Rhian %A Jones,Gareth David %+ Department of Physiotherapy, Guy's and St Thomas' NHS Foundation Trust, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, United Kingdom, 44 020 7188 7188 ext 53587, richard.myersingram@gstt.nhs.uk %K obesity %K eHealth %K technology %K weight management %K weight loss %K low socioeconomic status %K socioeconomic %K systematic review %K weight %K obese %D 2022 %7 20.1.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Obesity is a complex health condition with multiple associated comorbidities and increased economic costs. People from low socioeconomic status (SES) backgrounds are more likely to be overweight and obese and are less successful in traditional weight management programs. It is possible that eHealth interventions may be more successful in reaching people from low SES groups than traditional face-to-face models, by overcoming certain barriers associated with traditional interventions. It is not yet known, however, if eHealth weight management interventions are effective in people living with overweight and obesity from a low SES background. Objective: The primary aim of this study is to evaluate the efficacy of eHealth weight management interventions for people with overweight and obesity from low SES groups. Methods: A systematic review on relevant electronic databases (MEDLINE, Embase, Emcare, and CINAHL) will be undertaken to identify eligible studies published in English up until May 2021. Using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement to guide the systematic review, two reviewers will independently screen, select, and extract data and complete a risk of bias assessment of search results according to predefined criteria. Studies that have investigated an eHealth weight management intervention within a low SES population will be included. Primary outcomes include weight, BMI, and percentage weight change compared at baseline and at least one other time point. Secondary outcomes may include a range of anthropometric and physical fitness and activity measures. If sufficient studies are homogeneous, then we will pool results of individual outcomes using meta-analysis. Results: Searches have been completed, resulting in 2256 studies identified. Once duplicates were removed, 1545 studies remained for title and abstract review. Conclusions: The use of eHealth in weight management programs has increased significantly in recent years and will continue to do so; however, it is uncertain if eHealth weight management programs are effective in a low SES population. The results of this systematic review will therefore provide a summary of the evidence for interventions using eHealth for people living with overweight and obesity and from a low SES background. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42021243973; https://tinyurl.com/2p8fxtnw International Registered Report Identifier (IRRID): DERR1-10.2196/34546 %M 35049506 %R 10.2196/34546 %U https://www.researchprotocols.org/2022/1/e34546 %U https://doi.org/10.2196/34546 %U http://www.ncbi.nlm.nih.gov/pubmed/35049506 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e25384 %T Encouraging Behavior Changes and Preventing Cardiovascular Diseases Using the Prevent Connect Mobile Health App: Conception and Evaluation of App Quality %A Agher,Dahbia %A Sedki,Karima %A Despres,Sylvie %A Albinet,Jean-Pierre %A Jaulent,Marie-Christine %A Tsopra,Rosy %+ Inserm, University Sorbonne Paris Nord, Sorbonne University, Laboratory of Medical Informatics and Knowledge Engineering in e-Health, LIMICS, 15 Rue de l'école de Médecine, Paris, 75006, France, 33 0619260049, agherdahbia2@gmail.com %K digital health %K mHealth, mobile application %K IT %K technology %K prevention %K cardiovascular risk factor %K behavior change %K primary care %D 2022 %7 20.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Cardiovascular diseases are a major cause of death worldwide. Mobile health apps could help in preventing cardiovascular diseases by improving modifiable risk factors such as eating habits, physical activity levels, and alcohol or tobacco consumption. Objective: The aim of this study was to design a mobile health app, Prevent Connect, and to assess its quality for (1) assessing patient behavior for 4 cardiovascular risk factors (unhealthy eating, sedentary lifestyle, alcohol, and tobacco consumption) and (2) suggesting personalized recommendations and mobile health interventions for risky behaviors. Methods: The knowledge base of the app is based on French national recommendations for healthy eating, physical activity, and limiting alcohol and tobacco consumption. It contains a list of patient behaviors and related personalized recommendations and digital health interventions. The interface was designed according to usability principles. Its quality was assessed by a panel of 52 users in a 5-step process: completion of the demographic form, visualization of a short presentation of the app, testing of the app, completion of the user version of the Mobile App Rating Scale (uMARS), and an open group discussion. Results: This app assesses patient behaviors through specific questionnaires about 4 risk factors (unhealthy eating, sedentary lifestyle, alcohol, and tobacco consumption) and suggests personalized recommendations and digital health interventions for improving behavior. The app was deemed to be of good quality, with a mean uMARS quality score of 4 on a 5-point Likert scale. The functionality and information content of the app were particularly appreciated, with a mean uMARS score above 4. Almost all the study participants appreciated the navigation system and found the app easy to use. More than three-quarters of the study participants found the app content relevant, concise, and comprehensive. The aesthetics and the engagement of the app were also appreciated (uMARS score, 3.7). Overall, 80% (42/52) of the study participants declared that the app helped them to become aware of the importance of addressing health behavior, and 65% (34/52) said that the app helped motivate them to change lifestyle habits. Conclusions: The app assessed the risky behaviors of the patients and delivered personalized recommendations and digital health interventions for multiple risk factors. The quality of the app was considered to be good, but the impact of the app on behavior changes is yet to be demonstrated and will be assessed in further studies. %M 35049508 %R 10.2196/25384 %U https://www.jmir.org/2022/1/e25384 %U https://doi.org/10.2196/25384 %U http://www.ncbi.nlm.nih.gov/pubmed/35049508 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e28638 %T Engagement With a Mobile Phone–Based Life Skills Intervention for Adolescents and Its Association With Participant Characteristics and Outcomes: Tree-Based Analysis %A Paz Castro,Raquel %A Haug,Severin %A Debelak,Rudolf %A Jakob,Robert %A Kowatsch,Tobias %A Schaub,Michael P %+ Swiss Research Institute for Public Health and Addiction, University of Zurich, Konradstrasse 32, Zurich, 8051, Switzerland, 41 444481180, raquel.paz@isgf.uzh.ch %K engagement %K life skills %K adolescents %K mobile phone %K machine learning %K decision tree %K mobile phone %D 2022 %7 19.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Mobile phone–delivered life skills programs are an emerging and promising way to promote mental health and prevent substance use among adolescents, but little is known about how adolescents actually use them. Objective: The aim of this study is to determine engagement with a mobile phone–based life skills program and its different components, as well as the associations of engagement with adolescent characteristics and intended substance use and mental health outcomes. Methods: We performed secondary data analysis on data from the intervention group (n=750) from a study that compared a mobile phone–based life skills intervention for adolescents recruited in secondary and upper secondary school classes with an assessment-only control group. Throughout the 6-month intervention, participants received 1 SMS text message prompt per week that introduced a life skills topic or encouraged participation in a quiz or individual life skills training or stimulated sharing messages with other program participants through a friendly contest. Decision trees were used to identify predictors of engagement (use and subjective experience). The stability of these decision trees was assessed using a resampling method and by graphical representation. Finally, associations between engagement and intended substance use and mental health outcomes were examined using logistic and linear regression analyses. Results: The adolescents took part in half of the 50 interactions (mean 23.6, SD 15.9) prompted by the program, with SMS text messages being the most used and contests being the least used components. Adolescents who did not drink in a problematic manner and attended an upper secondary school were the ones to use the program the most. Regarding associations between engagement and intended outcomes, adolescents who used the contests more frequently were more likely to be nonsmokers at follow-up than those who did not (odds ratio 0.86, 95% CI 0.76-0.98; P=.02). In addition, adolescents who read the SMS text messages more attentively were less likely to drink in a problematic manner at follow-up (odds ratio 0.43, 95% CI 1.29-3.41; P=.003). Finally, participants who used the program the most and least were more likely to increase their well-being from baseline to 6-month follow-up compared with those with average engagement (βs=.39; t586=2.66; P=.008; R2=0.24). Conclusions: Most of the adolescents participating in a digital life skills program that aimed to prevent substance use and promote mental health engaged with the intervention. However, measures to increase engagement in problem drinkers should be considered. Furthermore, efforts must be made to ensure that interventions are engaging and powerful across different educational levels. First results indicate that higher engagement with digital life skills programs could be associated with intended outcomes. Future studies should apply further measures to improve the reach of lower-engaged participants at follow-up to establish such associations with certainty. %M 35044309 %R 10.2196/28638 %U https://www.jmir.org/2022/1/e28638 %U https://doi.org/10.2196/28638 %U http://www.ncbi.nlm.nih.gov/pubmed/35044309 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 1 %P e31989 %T A Remote Health Coaching, Text-Based Walking Program in Ethnic Minority Primary Care Patients With Overweight and Obesity: Feasibility and Acceptability Pilot Study %A Smart,Mary H %A Nabulsi,Nadia A %A Gerber,Ben S %A Gupta,Itika %A Di Eugenio,Barbara %A Ziebart,Brian %A Sharp,Lisa K %+ Department of Pharmacy Systems, Outcomes and Policy, College of Pharmacy, University of Illinois Chicago, 833 South Wood St, Chicago, IL, 60612, United States, 1 312 355 3569, sharpl@uic.edu %K mHealth %K Fitbit %K SMART goals %K texting %K health coach %K mobile phone %D 2022 %7 19.1.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Over half of US adults have at least one chronic disease, including obesity. Although physical activity is an important component of chronic disease self-management, few reach the recommended physical activity goals. Individuals who identify as racial and ethnic minorities are disproportionally affected by chronic diseases and physical inactivity. Interventions using consumer-based wearable devices have shown promise for increasing physical activity among patients with chronic diseases; however, populations with the most to gain, such as minorities, have been poorly represented to date. Objective: This study aims to assess the feasibility, acceptability, and preliminary outcomes of an 8-week text-based coaching and Fitbit program aimed at increasing the number of steps in a predominantly overweight ethnic minority population. Methods: Overweight patients (BMI >25 kg/m2) were recruited from an internal medicine clinic located in an inner-city academic medical center. Fitbit devices were provided. Using 2-way SMS text messaging, health coaches (HCs) guided patients to establish weekly step goals that were specific, measurable, attainable, realistic, and time-bound. SMS text messaging and Fitbit activities were managed using a custom-designed app. Program feasibility was assessed via the recruitment rate, retention rate (the proportion of eligible participants completing the 8-week program), and patient engagement (based on the number of weekly text message goals set with the HC across the 8-week period). Acceptability was assessed using a qualitative, summative evaluation. Exploratory statistical analysis included evaluating the average weekly steps in week 1 compared with week 8 using a paired t test (2-tailed) and modeling daily steps over time using a linear mixed model. Results: Of the 33 patients initially screened; 30 (91%) patients were enrolled in the study. At baseline, the average BMI was 39.3 (SD 9.3) kg/m2, with 70% (23/33) of participants presenting as obese. A total of 30% (9/30) of participants self-rated their health as either fair or poor, and 73% (22/30) of participants set up ≥6 weekly goals across the 8-week program. In total, 93% (28/30) of participants completed a qualitative summative evaluation, and 10 themes emerged from the evaluation: patient motivation, convenient SMS text messaging experience, social support, supportive accountability, technology support, self-determined goals, achievable goals, feedback from Fitbit, challenges, and habit formation. There was no significant group change in the average weekly steps for week 1 compared with week 8 (mean difference 7.26, SD 6209.3; P=.99). However, 17% (5/30) of participants showed a significant increase in their daily steps. Conclusions: Overall, the results demonstrate the feasibility and acceptability of a remotely delivered walking study that included an HC; SMS text messaging; a wearable device (Fitbit); and specific, measurable, attainable, realistic, and time-bound goals within an ethnic minority patient population. Results support further development and testing in larger samples to explore efficacy. %M 35044308 %R 10.2196/31989 %U https://formative.jmir.org/2022/1/e31989 %U https://doi.org/10.2196/31989 %U http://www.ncbi.nlm.nih.gov/pubmed/35044308 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 1 %P e24239 %T A Digital Intervention for Respiratory Tract Infections (Internet Dr): Process Evaluation to Understand How to Support Self-care for Minor Ailments %A Miller,Sascha %A Yardley,Lucy %A Smith,Peter %A Weal,Mark %A Anderson,Alexander %A Stuart,Beth %A Little,Paul %A Morrison,Leanne %+ Center for Clinical and Community Applications of Health Psychology, Department of Psychology, University of Southampton, Building 44, Highfield Campus, Southampton, SO17 1BJ, United Kingdom, 44 02380595000, S.Miller@soton.ac.uk %K illness behavior %K self-care %K internet %K evaluation studies %K respiratory tract infection %K mobile phone %D 2022 %7 19.1.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Approximately 57 million physician appointments annually in the United Kingdom are for minor ailments. These illnesses could be self-cared for, which would potentially lower patients’ anxiety, increase their confidence, and be more convenient. In a randomized controlled trial of the Internet Dr digital intervention, patients with access to the intervention had fewer consultations for respiratory tract infections (RTIs). Having established intervention efficacy, further examination of trial data is required to understand how the intervention works. Objective: This paper reports a process evaluation of Internet Dr usage by the intervention group. The evaluation aims to demonstrate how meaningful usage metrics (ie, interactions that are specific and relevant to the intervention) can be derived from the theoretical principles underlying the intervention, then applied to examine whether these interactions are effective in supporting self-care for RTIs, for whom, and at what time. Methods: The Internet Dr trial recorded patients’ characteristics and usage data over 24 weeks. At follow-up, users reported whether their levels of enablement to cope with their illness changed over the trial period. The Medical Research Council process evaluation guidance and checklists from the framework for Analyzing and Measuring Usage and Engagement Data were applied to structure research questions examining associations between usage and enablement. Results: Viewing pages containing advice on caring for RTIs were identified as a meaningful metric for measuring intervention usage. Almost half of the users (616/1491, 42.31%) viewed at least one advice page, with most people (478/616, 77.6%) accessing them when they initially enrolled in the study. Users who viewed an advice page reported increased enablement to cope with their illness as a result of having participated in the study compared with users who did not (mean 2.12, SD 2.92 vs mean 1.65, SD 3.10; mean difference 0.469, 95% CI 0.082-0.856). The target population was users who had visited their general practitioners for an RTI in the year before the trial, and analyses revealed that this group was more likely to access advice pages (odds ratio 1.35, 95% CI 1.159-1.571; P<.001). Conclusions: The process evaluation identifies viewing advice pages as associated with increased enablement to self-care, even when accessed in the absence of a RTI, meaning that dissemination activities need not be restricted to targeting users who are ill. The intervention was effective at reaching the target population of users who had previously consulted their general practitioners. However, attrition before reaching advice pages was high, highlighting the necessity of prioritizing access during the design phase. These findings provide guidance on how the intervention may be improved and disseminated and have wider implications for minor ailment interventions. %M 35044317 %R 10.2196/24239 %U https://formative.jmir.org/2022/1/e24239 %U https://doi.org/10.2196/24239 %U http://www.ncbi.nlm.nih.gov/pubmed/35044317 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e29703 %T Adherence, Efficacy, and Safety of Wearable Technology–Assisted Combined Home-Based Exercise in Chinese Patients With Ankylosing Spondylitis: Randomized Pilot Controlled Clinical Trial %A Wang,Yiwen %A Liu,Xingkang %A Wang,Weimin %A Shi,Yanyun %A Ji,Xiaojian %A Hu,Lidong %A Wang,Lei %A Yin,Yiquan %A Xie,Siyuan %A Zhu,Jian %A Zhang,Jianglin %A Jiao,Wei %A Huang,Feng %+ Department of Rheumatology and Immunology, First Medical Center, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Beijing, 100853, China, 86 010 5549 9314, fhuang@301hospital.com.cn %K ankylosing spondylitis %K wearable technology %K home-based exercise %K combined exercise %K randomized controlled trial %K RCT %K exercise %K wearable %K photoplethysmography %K spondyloarthritis %D 2022 %7 18.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Clinical practice guidelines recommend that exercise is essential in the self-management of ankylosing spondylitis (AS). Attending supervised interventions requiring periodic medical center visits can be difficult and patients may decline participation, whereas effective home-based exercise interventions that do not require regular medical center visits are likely to be more accessible for AS patients. Objective: The goal of the research was to investigate the adherence, efficacy, and safety of a wearable technology–assisted combined home-based exercise program in AS. Methods: This was a 16-week investigator-initiated, assessor-blinded, randomized, pilot controlled trial conducted at Chinese People’s Liberation Army General Hospital. We enrolled patients with AS who had no regular exercise habits and had been stable in drug treatment for the preceding month. Patients were randomly assigned (1:1) using a computer algorithm. An exercise program consisting of moderate-intensity aerobic exercise and functional exercise was given to the patients in the intervention group. The exercise intensity was controlled by a Mio FUSE Heart Rate Monitor wristband, which uses photoplethysmography to measure heart rate. Patients in the control group received usual care. The primary outcome was the difference in the Ankylosing Spondylitis Disease Activity Score (ASDAS). The secondary outcomes were patient global assessment (PGA), physician global assessment (PhGA), total pain, nocturnal pain, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BAS Functional Index (BASFI), BAS Metrology Index (BASMI), Spondyloarthritis International Society Health Index (ASAS HI), 36-item Short Form Survey (SF-36), maximal oxygen uptake (VO2) max, body composition, range of motion of joints, and muscle endurance tests. Retention rate, adherence rate, barriers to being active, and adverse events were also assessed. Results: A total of 77 patients were screened, of whom 55 (71%) patients were enrolled; 2% (1/55) withdrew without treatment after randomization. Patients were assigned to the intervention (n=26) or control group (n=28). The median adherence rate of the prescribed exercise protocol was 84.2% (IQR 48.7%-97.9%). For the primary outcome, between-group difference of ASDAS was significant, favoring the intervention (–0.2, 95% CI –0.4 to 0.02, P=.03). For the secondary outcomes, significant between-group differences at 16 weeks were detected in PGA, PhGA, total pain, BASDAI, BASDAI-fatigue, BASDAI–spinal pain, BASDAI–morning stiffness intensity, BASFI, and BASMI. Moreover, the frequency of difficulty in ASAS HI-motivation at 16 weeks was less in the intervention group (P=.03). Between-group difference for change from baseline were also detected in VO2 max, SF-36, back extensor endurance test, and the range of motion of cervical lateral flexion at 16 weeks. Lack of time, energy, and willpower were the most distinct barriers to being active. Incidences of adverse events were similar between groups (P=.11). Conclusions: Our pilot study suggests that this technology-assisted combined home-based exercise program can improve the clinical outcomes of patients with AS who have no exercise habit, with good adherence and safety profile. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900024244; http://www.chictr.org.cn/showproj.aspx?proj=40176 %M 35040798 %R 10.2196/29703 %U https://www.jmir.org/2022/1/e29703 %U https://doi.org/10.2196/29703 %U http://www.ncbi.nlm.nih.gov/pubmed/35040798 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 7 %N 1 %P e25105 %T Evaluation of a Web Platform to Record Lifestyle Habits in Subjects at Risk of Developing Type 2 Diabetes in a Middle-Income Population: Prospective Interventional Study %A Sevilla-Gonzalez,Magdalena Del Rocio %A Bourguet-Ramirez,Brigette %A Lazaro-Carrera,Laura Sofia %A Martagon-Rosado,Alexandro J %A Gomez-Velasco,Donaji Veronica %A Viveros-Ruiz,Tannia Leticia %+ Clinical and Translational Epidemiology Unit, Massachusetts General Hospital, 100 Cambridge St, Boston, MA, 02114, United States, 1 6176435806, msevillagonzalez@mgh.harvard.edu %K mHealth %K prediabetes %K type 2 diabetes %K preventive medicine %K diabetes %K lifestyle %K body mass index %D 2022 %7 17.1.2022 %9 Original Paper %J JMIR Diabetes %G English %X Background: Lifestyle is the focus of type 2 diabetes (T2D) prevention strategies. Prevention strategies using mobile health (mHealth)–based therapy have shown positive results for T2D prevention in high-income settings, but little is known about their effectiveness in low- and middle-income populations where the burden of T2D is substantial. “Vida Sana” is a web platform designed to record lifestyle habits and medication use within a lifestyle change program. Objective: We sought to identify the barriers, feasibility, usability, and effectiveness of Vida Sana to record lifestyle habits in subjects at risk of developing T2D in a middle-income setting. Methods: This was a 3-month prospective interventional study in Mexican individuals. A total of 77 subjects at risk of T2D (with prediabetes and BMI between 24 and 40 kg/m2) were selected. Feasibility was assessed by study retention. Usability was evaluated with the System Usability Scale (SUS). Effectiveness measures included changes in weight, body composition, BMI, glycated hemoglobin A1c (HbA1c), and fasting blood glucose from baseline to 3 months. Linear regression models were used to account for covariates. Results: The feasibility of Vida Sana was 42%, with 33 subjects using the platform, and the usability was 48.7 (SD 14.24). Reported barriers to platform usage were; difficulty in accessing the platform from difficulty of use (12 subjects, 36%), lack of time to record their habits (11 subjects, 34%), lack of interest to record their habits (6 subjects, 18%), and lack of resources (4 subjects, 11%). The platform was effective for lowering glucose in fasting (–3.1 mg/dL vs –0.11 [SD 8.08] mg/dL; P=.038) and at 2 hours (–16.9 mg/dL vs 2.5 [SD 26.1] mg/dL; P=.045), body fat percentage (–1.3 [–2.2 to –0.7] vs –1.02 [–1.9 to –0.3]; P=.02), and waist circumference (–3.2 [SD 5.1] cm vs –1.7 [SD 5.0] cm; P=.02) independent of their age, sex, treatment, and education level. Conclusions: The use of the web platform was effective for improving glycemic and anthropometric parameters in a population at risk of developing diabetes. Improving accessibility and ease of navigation could improve the acceptance of digital health solutions in a middle-income population. %M 35037888 %R 10.2196/25105 %U https://diabetes.jmir.org/2022/1/e25105 %U https://doi.org/10.2196/25105 %U http://www.ncbi.nlm.nih.gov/pubmed/35037888 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 6 %N 1 %P e24174 %T The Impact of a Mobile App on Participation in Cardiac Rehabilitation and Understanding Barriers to Success: Comparative Cohort Study %A Rivers,John T %A Smith,Carla %A Smith,Ian %A Cameron,James %+ Queensland Cardiovascular Group, St Andrew's Specialist Centre, 457 Wickham Terrace, Brisbane, 4004, Australia, 61 438601941, johnr@qcg.com.au %K cardiac rehabilitation %K digital health %K smartphone app %K Cardihab %K participation rates %K rehabilitation %K cardiology %K heart %K app %K barrier %D 2022 %7 17.1.2022 %9 Original Paper %J JMIR Cardio %G English %X Background: Poor patient uptake of cardiac rehabilitation (CR) remains a challenge for multiple reasons including geographic, time, cultural, cost, and psychological constraints. Objective: We evaluated the impact on CR participation rates associated with the addition of the option of mobile app–based CR (Cardihab) for patients declining conventional CR. Methods: A total of 204 consecutive patients were offered CR following angioplasty; of these, 99 were in cohort 1 (offered conventional CR only) and 105 were in cohort 2 (app-based CR offered to those declining conventional CR). Patients in each cohort were followed throughout a 6-week CR program and participation rates were compared for both groups. Patients in cohort 2 declining both forms of CR were interviewed to assess reasons for nonparticipation. Results: CR participation improved from 21% (95% CI 14%-30%) to 63% (95% CI 53%-71%) with the addition of the app (P<.001). Approximately 25% (9/39) of the group declining the app-based program identified technology issues as the reason for nonparticipation. The remainder declined both CR programs or were ineligible due to frailty or comorbidities. Conclusions: Providing patients with the additional option of an app-based CR program substantially improved CR participation. Technology and psychological barriers can limit CR participation. Further innovation in CR delivery systems is required to improve uptake. %M 35037891 %R 10.2196/24174 %U https://cardio.jmir.org/2022/1/e24174 %U https://doi.org/10.2196/24174 %U http://www.ncbi.nlm.nih.gov/pubmed/35037891 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 5 %N 1 %P e33118 %T Development of a Community-Based e-Health Program for Older Adults With Chronic Diseases: Pilot Pre-Post Study %A Wu,Vivien Xi %A Dong,Yanhong %A Tan,Poh Choo %A Gan,Peiying %A Zhang,Di %A Chi,Yuchen %A Chao,Felicia Fang Ting %A Lu,Jinhua %A Teo,Boon Heng Dennis %A Tan,Yue Qian %+ Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 2, Clinical Research Centre, Block MD11, 10 Medical Drive, Singapore, 117597, Singapore, 65 66012756, nurwux@nus.edu.sg %K eHealth %K self-management %K older adults %K chronic disease %K community care %K elderly %K community %K innovation %K development %K pilot %K evaluation %K health literacy %K empowerment %K feasibility %K engagement %D 2022 %7 17.1.2022 %9 Original Paper %J JMIR Aging %G English %X Background: Chronic diseases may impact older adults’ health outcomes, health care costs, and quality of life. Self-management is expected to encourage individuals to make autonomous decisions, adhere to treatment plans, deal with emotional and social consequences, and provide choices for healthy lifestyle. New eHealth solutions significantly increase the health literacy and empower patients in self-management of chronic conditions. Objective: This study aims to develop a Community-Based e-Health Program (CeHP) for older adults with chronic diseases and conduct a pilot evaluation. Methods: A pilot study with a 2-group pre- and posttest repeated measures design was adopted. Community-dwelling older adults with chronic diseases were recruited from senior activity centers in Singapore. A systematic 3-step process of developing CeHP was coupled with a smart-device application. The development of the CeHP intervention consists of theoretical framework, client-centric participatory action research process, content validity assessment, and pilot testing. Self-reported survey questionnaires and health outcomes were measured before and after the CeHP. The instruments used were the Self-care of Chronic Illness Inventory (SCCII), Healthy Aging Instrument (HAI), Short-Form Health Literacy Scale, 12 Items (HLS-SF 12), Patient Empowerment Scale (PES), and Social Support Questionnaire, 6 items. The following health outcomes were measured: Montreal Cognitive Assessment, Symbol Digit Modalities Test, total cholesterol (TC), high-density lipoproteins, low-density lipoproteins/very-low-density lipoproteins (LDL/VLDL), fasting glucose, glycated hemoglobin (HbA1c), and BMI. Results: The CeHP consists of health education, monitoring, and an advisory system for older adults to manage their chronic conditions. It is an 8-week intensive program, including face-to-face and eHealth (Care4Senior App) sessions. Care4Senior App covers health education topics focusing on the management of hypertension, hyperlipidemia, and diabetes, brain health, healthy diet, lifestyle modification, medication adherence, exercise, and mindfulness practice. Content validity assessment indicated that the content of the CeHP is valid, with a content validity index (CVI) ranging 0.86-1 and a scale-CVI of 1. Eight participants in the CeHP group and 4 in the control group completed both baseline and post intervention assessments. Participants in the CeHP group showed improvements in fasting glucose, HbA1c, TC, LDL/VLDL, BMI, SCCII indices (Maintenance, Monitoring, and Management), HAI, and PES scores post intervention, although these changes were not significant. For the participants in the control group, the scores for SCCII (management and confidence) and HLS-SF 12 decreased post intervention. Conclusions: The CeHP is feasible, and it engages and empowers community-dwelling older adults to manage their chronic conditions. The rigorous process of program development and pilot evaluation provided valid evidence to expand the CeHP to a larger-scale implementation to encourage self-management, reduce debilitating complications of poorly controlled chronic diseases, promote healthy longevity and social support, and reduce health care costs. %M 35037882 %R 10.2196/33118 %U https://aging.jmir.org/2022/1/e33118 %U https://doi.org/10.2196/33118 %U http://www.ncbi.nlm.nih.gov/pubmed/35037882 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 1 %P e32627 %T Expert-Moderated Peer-to-Peer Online Support Group for People With Knee Osteoarthritis: Mixed Methods Randomized Controlled Pilot and Feasibility Study %A Egerton,Thorlene %A Lawford,Belinda J %A Campbell,Penny K %A Plinsinga,Melanie L %A Spiers,Libby %A Mackenzie,David A %A Graham,Bridget %A Mills,Kathryn %A Eyles,Jillian %A Knox,Gabrielle %A Metcalf,Ben %A Maclachlan,Liam R %A Besomi,Manuela %A Dickson,Chris %A Abraham,Charles %A Vicenzino,Bill %A Hodges,Paul W %A Hunter,David J %A Bennell,Kim L %+ Centre for Health, Exercise & Sports Medicine, The University of Melbourne, Level 7, Alan Gilbert Building, Melbourne, VIC 3010, Australia, 61 3 83441233, thorlene.egerton@unimelb.edu.au %K support group %K online support group %K knee %K osteoarthritis %K arthritis %K online forums %K patient education %K self-efficacy %K health literacy %K self-management %K qualitative %D 2022 %7 17.1.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Osteoarthritis (OA) is a major problem globally. First-line management comprises education and self-management strategies. Online support groups may be a low-cost method of facilitating self-management. Objective: The aim of this randomized controlled pilot study is to evaluate the feasibility of the study design and implementation of an evidence-informed, expert-moderated, peer-to-peer online support group (My Knee Community) for people with knee OA. The impacts on psychological determinants of self-management, selected self-management behaviors, and health outcomes were secondary investigations. Methods: This mixed methods study evaluated study feasibility (participant recruitment, retention, and costs), experimental intervention feasibility (acceptability and fidelity to the proposed design, including perceived benefit, satisfaction, and member engagement), psychological determinants (eg, self-efficacy and social support), behavioral measures, health outcomes, and harms. Of a total of 186, 63 (33.9%) participants (41/63, 65% experimental and 22/63, 35% control) with self-reported knee OA were recruited from 186 volunteers. Experimental group participants were provided membership to My Knee Community, which already had existing nonstudy members, and were recommended a web-based education resource (My Joint Pain). The control group received the My Joint Pain website recommendation only. Participants were not blinded to their group allocation or the study interventions. Participant-reported data were collected remotely using web-based questionnaires. A total of 10 experimental group participants also participated in semistructured interviews. The transcribed interview data and all forum posts by the study participants were thematically analyzed. Results: Study feasibility was supported by acceptable levels of retention; however, there were low levels of engagement with the support group by participants: 15% (6/41) of participants did not log in at all; the median number of times visited was 4 times per participant; only 29% (12/41) of participants posted, and there were relatively low levels of activity overall on the forum. This affected the results for satisfaction (overall mean 5.9/10, SD 2.7) and perceived benefit (17/31, 55%: yes). There were no differences among groups for quantitative outcomes. The themes discussed in the interviews were connections and support, information and advice, and barriers and facilitators. Qualitative data suggest that there is potential for people to derive benefit from connecting with others with knee OA by receiving support and assisting with unmet informational needs. Conclusions: Although a large-scale study is feasible, the intervention implementation was considered unsatisfactory because of low levels of activity and engagement by members. We recommend that expectations about the support group need to be made clear from the outset. Additionally, the platform design needs to be more engaging and rewarding, and membership should only be offered to people willing to share their personal stories and who are interested in learning from the experiences of others. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619001230145; http://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377958 %M 35037880 %R 10.2196/32627 %U https://formative.jmir.org/2022/1/e32627 %U https://doi.org/10.2196/32627 %U http://www.ncbi.nlm.nih.gov/pubmed/35037880 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 8 %N 1 %P e29485 %T A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Results of a Randomized Clinical Trial %A Fu,Mei Rosemary %A Axelrod,Deborah %A Guth,Amber A %A Scagliola,Joan %A Rampertaap,Kavita %A El-Shammaa,Nardin %A Qiu,Jeanna M %A McTernan,Melissa L %A Frye,Laura %A Park,Christopher S %A Yu,Gary %A Tilley,Charles %A Wang,Yao %+ School of Nursing-Camden, Rutgers University, 530 Federal Street, Camden, NJ, 08102, United States, 1 9739861758, mei.r.fu@rutgers.edu %K pain %K lymphatic exercises %K symptoms %K lymphedema %K breast cancer %K health behavior %K mHealth %D 2022 %7 17.1.2022 %9 Original Paper %J JMIR Cancer %G English %X Background: The-Optimal-Lymph-Flow (TOLF) is a patient-centered, web- and mobile-based mHealth system that delivers safe, easy, and feasible digital therapy of lymphatic exercises and limb mobility exercises. Objective: The purpose of this randomized clinical trial (RCT) was to evaluate the effectiveness of the web- and mobile-based TOLF system for managing chronic pain and symptoms related to lymphedema. The primary outcome includes pain reduction, and the secondary outcomes focus on symptom relief, limb volume difference measured by infrared perometer, BMI, and quality of life (QOL) related to pain. We hypothesized that participants in the intervention group would have improved pain and symptom experiences, limb volume difference, BMI, and QOL. Methods: A parallel RCT with a control–experimental, pre- and posttest, and repeated-measures design were used. A total of 120 patients were recruited face-to-face at the point of care during clinical visits. Patients were randomized according to pain in a 1:1 ratio into either the arm precaution (AP) control group to improve limb mobility and arm protection or The-Optimal-Lymph flow (TOLF) intervention group to promote lymph flow and limb mobility. Trial outcomes were evaluated at baseline and at week 12 after the intervention. Descriptive statistics, Fisher exact tests, Wilcoxon rank-sum tests, t test, and generalized linear mixed effects models were performed for data analysis. Results: At the study endpoint of 12 weeks, significantly fewer patients in the TOLF intervention group compared with the AP control group reported chronic pain (45% [27/60] vs 70% [42/60]; odds ratio [OR] 0.39, 95% CI 0.17-0.90; P=.02). Patients who received the TOLF intervention were significantly more likely to achieve a complete reduction in pain (50% [23/46] vs 22% [11/51]; OR 3.56, 95% CI 1.39-9.76; P=.005) and soreness (43% [21/49] vs 22% [11/51]; OR 2.60, 95% CI 1.03-6.81; P=.03). Significantly lower median severity scores were found in the TOLF group for chronic pain (MedTOLF=0, IQR 0-1 vs MedAP=1, IQR 0-2; P=.02) and general bodily pain (MedTOLF=1, IQR=0-1.5 vs MedAP=1, IQR 1-3; P=.04). Compared with the AP control group, significantly fewer patients in the TOLF group reported arm/hand swelling (P=.04), heaviness (P=.03), redness (P=.03), and limited movement in shoulder (P=.02) and arm (P=.03). No significant differences between the TOLF and AP groups were found in complete reduction of aching (P=.12) and tenderness (P=.65), mean numbers of lymphedema symptom reported (P=.11), ≥5% limb volume differences (P=.48), and BMI (P=.12). Conclusions: The TOLF intervention had significant benefits for breast cancer survivors to manage chronic pain, soreness, general bodily pain, arm/hand swelling, heaviness, and impaired limb mobility. The intervention resulted in a 13% reduction (from 40% [24/60] to 27% [16/60]) in proportions of patients who took pain medications compared with the AP control group, which had a 5% increase (from 40% [24/60] to 45% [27/60]). A 12% reduction (from 27% [16/60] to 15% [9/60]) in proportions of patients with ≥5% limb volume differences was found in the TOLF intervention, while a 5% increase in the AP control group (from 40% [24/60] to 45% [27/60]) was found. In conclusion, the TOLF intervention can be a better choice for breast cancer survivors to reduce chronic pain and limb volume. Trial Registration: Clinicaltrials.gov NCT02462226; https://clinicaltrials.gov/ct2/show/NCT02462226 International Registered Report Identifier (IRRID): RR2-10.2196/resprot.5104 %M 35037883 %R 10.2196/29485 %U https://cancer.jmir.org/2022/1/e29485 %U https://doi.org/10.2196/29485 %U http://www.ncbi.nlm.nih.gov/pubmed/35037883 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e31664 %T Factors Associated With the Experience of Cognitive Training Apps for the Prevention of Dementia: Cross-sectional Study Using an Extended Health Belief Model %A Lee,Jaegyeong %A Lim,Jung Min %+ Department of Pharmacology, Yonsei University College of Medicine, Avison Biomedical Research Center, Room 318, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea, 82 2 2228 0925, dreamist88@gmail.com %K cognitive training apps %K dementia knowledge %K health belief model %K middle-aged %K logistic regression analysis %K dementia %K Alzheimer disease %K cognition %K mobile apps %K health apps %D 2022 %7 14.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The prevalence and economic burden of dementia are increasing dramatically. Using information communication technology to improve cognitive functions is proven to be effective and holds the potential to serve as a new and efficient method for the prevention of dementia. Objective: The aim of this study was to identify factors associated with the experience of mobile apps for cognitive training in middle-aged adults. We evaluated the relationships between the experience of cognitive training apps and structural variables using an extended health belief model. Methods: An online survey was conducted on South Korean participants aged 40 to 64 years (N=320). General characteristics and dementia knowledge were measured along with the health belief model constructs. Statistical analysis and logistic regression analysis were performed. Results: Higher dementia knowledge (odds ratio [OR] 1.164, P=.02), higher perceived benefit (OR 1.373, P<.001), female gender (OR 0.499, P=.04), and family history of dementia (OR 1.933, P=.04) were significantly associated with the experience of cognitive training apps for the prevention of dementia. Conclusions: This study may serve as a theoretical basis for the development of intervention strategies to increase the use of cognitive training apps for the prevention of dementia. %M 35029540 %R 10.2196/31664 %U https://www.jmir.org/2022/1/e31664 %U https://doi.org/10.2196/31664 %U http://www.ncbi.nlm.nih.gov/pubmed/35029540 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 7 %N 1 %P e23243 %T A 12-Month Follow-Up of the Effects of a Digital Diabetes Prevention Program (VP Transform for Prediabetes) on Weight and Physical Activity Among Adults With Prediabetes: Secondary Analysis %A Batten,Ryan %A Alwashmi,Meshari F %A Mugford,Gerald %A Nuccio,Misa %A Besner,Angele %A Gao,Zhiwei %+ Memorial University of Newfoundland, 300 Prince Philip Drive, St John's, NL, A1B 3V6, Canada, 1 7096910728, mfa720@mun.ca %K mHealth %K mobile health %K diabetes %K DPP %K diabetes prevention program %K digital health %K longitudinal study %K prevention %K weight loss %K physical activity %D 2022 %7 14.1.2022 %9 Original Paper %J JMIR Diabetes %G English %X Background: The prevalence of diabetes is increasing rapidly. Previous research has demonstrated the efficacy of a diabetes prevention program (DPP) in lifestyle modifications that can prevent or delay the onset of type 2 diabetes among individuals at risk. Digital DPPs have the potential to use technology, in conjunction with behavior change science, to prevent prediabetes on a national and global scale. Objective: The aim of this study is to investigate the effects of a digital DPP (Virgin Pulse [VP] Transform for Prediabetes) on weight and physical activity among participants who had completed 12 months of the program. Methods: This study was a secondary analysis of retrospective data of adults with prediabetes who were enrolled in VP Transform for Prediabetes for 12 months of the program. The program incorporates interactive mobile computing, remote monitoring, an evidence-based curriculum, behavior tracking tools, health coaching, and online peer support to prevent or delay the onset of type 2 diabetes. Results: The sample (N=1095) was comprised of people with prediabetes who completed at least 9 months of the VP Transform for Prediabetes program. Participants were 67.7% (n=741) female, with a mean age of 53.6 (SD 9.75) years. After 12 months, participants decreased their weight by an average of 10.9 lbs (5.5%; P<.001) and increased their physical activity by 91.2 (P<.001) minutes. Conclusions: These results suggest that VP Transform for Prediabetes is effective at preventing type 2 diabetes through a significant reduction in body weight and increase of physical activity. Furthermore, these results suggest that the DPP remains effective 12 months after beginning the program. A prospective randomized controlled clinical study is warranted to validate these findings. %M 35029532 %R 10.2196/23243 %U https://diabetes.jmir.org/2022/1/e23243 %U https://doi.org/10.2196/23243 %U http://www.ncbi.nlm.nih.gov/pubmed/35029532 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 1 %P e35593 %T A Mindfulness-Based Intervention to Alleviate Stress From Discrimination Among Young Sexual and Gender Minorities of Color: Protocol for a Pilot Optimization Trial %A Cook,Stephanie H %A Wood,Erica P %A Mirin,Nicholas %A Bandel,Michelle %A Delorme,Maxline %A Gad,Laila %A Jayakar,Olive %A Mustafa,Zainab %A Tatar,Raquel %A Javdani,Shabnam %A Godfrey,Erin %+ Department of Social and Behavioral Sciences, School of Global Public Health, New York University, 708 Broadway, 7th Floor, New York, NY, 10003, United States, 1 212 992 5635, sc5810@nyu.edu %K sexual and gender minorities %K racial/ethnic minorities %K mindfulness %K mobile phone %D 2022 %7 14.1.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Young sexual and gender minorities (SGMs) of color may face unique experiences of discrimination based on their intersectional positions (eg, discrimination based on both racial or ethnic identity and sexual identity). Emerging evidence suggests that mindfulness practices may reduce stress from discrimination and improve overall well-being among young SGM. Moreover, the omnipresence of smartphone access among racial or ethnic and sexual minority communities provides a method through which to administer mindfulness-based interventions among young SGMs of color. Objective: This paper outlines the protocol of the Optimizing a Daily Mindfulness Intervention to Reduce Stress from Discrimination among Young Sexual and Gender Minorities of Color (REDUCE) study, a pilot optimization trial of a smartphone-based mindfulness intervention that was developed in conjunction with the Healthy Minds Program (HMP) with the aim of reducing stress from discrimination among young SGMs. Methods: In total, 80 young (ages 18-29 years) SGMs of color will be enrolled in the study. The HMP is a self-guided meditation practice, and participants will be randomized to either a control condition or an intervention that uses a neuroscience-based approach to mindfulness. We will use the multiphase optimization strategy to assess which combination of mindfulness interventions is the most effective at reducing stress from discrimination among young SGMs of color. A combination of mindfulness-based meditation intervention components will be examined, comprising mindfulness-based practices of awareness, connection, and purpose. Awareness refers to the practice of self-awareness, which reduces the mind’s ability to be distracted and instead be present in the moment. Connection refers to the practice of connection with oneself and others and emphasizes on empathy and compassion with oneself and others. Purpose encourages goal-making in accordance with one’s values and management of behavior in accordance with these goals. In addition, we will assess the feasibility and acceptability of the HMP application among young SGMs of color. Results: The REDUCE study was approved by the Institutional Review Board of New York University, and recruitment and enrollment began in the winter of 2021. We expect to complete enrollment by the summer of 2022. The results will be disseminated via social media, journal articles, abstracts, or presentations, as well as to participants, who will be given the opportunity to provide feedback to the researchers. Conclusions: This optimization trial is designed to test the efficacy, feasibility, and acceptability of implementing an application-based, mindfulness-based intervention to reduce stress from discrimination and improve well-being among young SGMs of color. Evidence from this study will assist in the creation of a sustainable, culturally relevant mobile app–based mindfulness intervention to reduce stress from discrimination among young SGMs of color. Trial Registration: Clinicaltrials.gov NCT05131360; https://clinicaltrials.gov/ct2/show/NCT05131360 International Registered Report Identifier (IRRID): DERR1-10.2196/35593 %M 34928237 %R 10.2196/35593 %U https://www.researchprotocols.org/2022/1/e35593 %U https://doi.org/10.2196/35593 %U http://www.ncbi.nlm.nih.gov/pubmed/34928237 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e29559 %T Web-Based Problem-solving Training With and Without Peer Support in Veterans With Unmet Mental Health Needs: Pilot Study of Feasibility, User Acceptability, and Participant Engagement %A Possemato,Kyle %A Wu,Justina %A Greene,Carolyn %A MacQueen,Rex %A Blonigen,Daniel %A Wade,Michael %A Owen,Jason %A Keane,Terence %A Brief,Deborah %A Lindley,Steven %A Prins,Annabel %A Mackintosh,Margaret-Anne %A Carlson,Eve %+ National Center for Post Traumatic Stress Disorder, Veterans Affairs Palo Alto Health Care System, 3801 Miranda Avenue, Palo Alto, CA, 94304, United States, 1 6507143064, eve.carlson@va.gov %K problem-solving training %K mHealth %K peer specialists %K veterans %D 2022 %7 13.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: eHealth tools have the potential to meet the mental health needs of individuals who experience barriers to accessing in-person treatment. However, most users have less than optimal engagement with eHealth tools. Coaching from peer specialists may increase their engagement with eHealth. Objective: This pilot study aims to test the feasibility and acceptability of a novel, completely automated web-based system to recruit, screen, enroll, assess, randomize, and then deliver an intervention to a national sample of military veterans with unmet mental health needs; investigate whether phone-based peer support increases the use of web-based problem-solving training compared with self-directed use; and generate hypotheses about potential mechanisms of action for problem-solving and peer support for future full-scale research. Methods: Veterans (N=81) with unmet mental health needs were recruited via social media advertising and enrolled and randomized to the self-directed use of a web-based problem-solving training called Moving Forward (28/81, 35%), peer-supported Moving Forward (27/81, 33%), or waitlist control (26/81, 32%). The objective use of Moving Forward was measured with the number of log-ins. Participants completed pre- and poststudy measures of mental health symptoms and problem-solving confidence. Satisfaction was also assessed post treatment. Results: Automated recruitment, enrollment, and initial assessment methods were feasible and resulted in a diverse sample of veterans with unmet mental health needs from 38 states. Automated follow-up methods resulted in 46% (37/81) of participants completing follow-up assessments. Peer support was delivered with high fidelity and was associated with favorable participant satisfaction. Participants randomized to receive peer support had significantly more Moving Forward log-ins than those of self-directed Moving Forward participants, and those who received peer support had a greater decrease in depression. Problem-solving confidence was associated with greater Moving Forward use and improvements in mental health symptoms among participants both with and without peer support. Conclusions: Enrolling and assessing individuals in eHealth studies without human contact is feasible; however, different methods or designs are necessary to achieve acceptable participant engagement and follow-up rates. Peer support shows potential for increasing engagement in web-based interventions and reducing symptoms. Future research should investigate when and for whom peer support for eHealth is helpful. Problem-solving confidence should be further investigated as a mechanism of action for web-based problem-solving training. Trial Registration: ClinicalTrials.gov NCT03555435; http://clinicaltrials.gov/ct2/show/NCT03555435 %M 35023846 %R 10.2196/29559 %U https://www.jmir.org/2022/1/e29559 %U https://doi.org/10.2196/29559 %U http://www.ncbi.nlm.nih.gov/pubmed/35023846 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e30026 %T Engagement Strategies to Improve Adherence and Retention in Web-Based Mindfulness Programs: Systematic Review %A Winter,Natalie %A Russell,Lahiru %A Ugalde,Anna %A White,Victoria %A Livingston,Patricia %+ Centre for Quality and Patient Safety Research in the Institute for Health Transformation, Deakin University, 1 Gheringhap Street, Geelong, 3220, Australia, 61 3 5227 1100, n.heynsbergh@deakin.edu.au %K chronic disease %K chronic illness %K digital health %K digital technology %K internet mindfulness %K mindfulness based stress reduction %K patient dropouts %K mobile phone %D 2022 %7 12.1.2022 %9 Review %J J Med Internet Res %G English %X Background: Web-based mindfulness programs may be beneficial in improving the well-being outcomes of those living with chronic illnesses. Adherence to programs is a key indicator in improving outcomes; however, with the digitization of programs, it is necessary to enhance engagement and encourage people to return to digital health platforms. More information is needed on how engagement strategies have been used in web-based mindfulness programs to encourage adherence. Objective: The aim of this study is to develop a list of engagement strategies for web-based mindfulness programs and evaluate the impact of engagement strategies on adherence. Methods: A narrative systematic review was conducted across the MEDLINE Complete, CINAHL Complete, APA PsycINFO, and Embase databases and followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines. Articles were screened using the population, intervention, comparator, and outcome framework. Adults aged >18 years with chronic health conditions were included in the study. Mindfulness interventions, including those in combination with mindfulness-based cognitive therapy, delivered on the web through the internet or smartphone technology were included. Interventions lasted at least 2 weeks. Studies with a randomized controlled trial design or a pilot randomized controlled trial design were included. Engagement strategies, including web-based program features and facilitator-led strategies, adherence, and retention, were included. Results: A total of 1265 articles were screened, of which 19 were relevant and were included in the review. On average, 70.98% (2258/3181) of the study participants were women with a mean age of 46 (SD 13) years. Most commonly, mindfulness programs were delivered to people living with mental health conditions (8/19, 42%). Of the 19 studies, 8 (42%) used only program features to encourage adherence, 5 (26%) used facilitator-led strategies, and 6 (32%) used a combination of the two. Encouraging program adherence was the most common engagement strategy used, which was used in 77% (10/13) of the facilitator-led studies and 57% (8/14) of the program feature studies. Nearly two-thirds (63%) of the studies provided a definition of adherence, which varied between 50% and 100% completion across studies. The overall mean participant compliance to the mindfulness programs was 56% (SD 15%). Most studies (10/19, 53%) had a long-term follow-up, with the most common follow-up period being 12 weeks after intervention (3/10, 30%). After the intervention, the mean retention was 78% (SD 15%). Conclusions: Engagement strategies in web-based mindfulness programs comprise reminders to use the program. Other features may be suitable for encouraging adherence to interventions, and a facilitator-led component may result in higher retention. There is variance in the way adherence is measured, and intervention lengths and follow-up periods are inconsistent. More thorough reporting and a standardized framework for measuring adherence are needed to more accurately assess adherence and engagement strategies. %M 35019851 %R 10.2196/30026 %U https://www.jmir.org/2022/1/e30026 %U https://doi.org/10.2196/30026 %U http://www.ncbi.nlm.nih.gov/pubmed/35019851 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 1 %P e34792 %T Single-Group Trial of an Internet-Delivered Insomnia Intervention Among Higher-Intensity Family Caregivers: Rationale and Protocol for a Mixed Methods Study %A Shaffer,Kelly M %A Ritterband,Lee M %A You,Wen %A Buysse,Daniel J %A Mattos,Meghan K %A Camacho,Fabian %A Glazer,Jillian V %A Klinger,Julie %A Donovan,Heidi %+ Center for Behavioral Health and Technology, University of Virginia, PO Box 801075, Charlottesville, VA, 22908, United States, 1 4349821022, kshaffer@virginia.edu %K family caregiver %K cognitive behavioral therapy %K insomnia %K sleep initiation and maintenance disorders %K eHealth %K protocol %K mobile phone %D 2022 %7 12.1.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Family caregivers are more likely to experience insomnia relative to noncaregivers but have significant barriers to accessing gold standard cognitive behavioral therapy for insomnia treatment. Delivering interventions to caregivers through the internet may help increase access to care, particularly among higher-intensity caregivers who provide assistance with multiple care tasks over many hours per week. Although there are existing internet interventions that have been thoroughly studied and demonstrated as effective in the general population, the extent to which these interventions may be effective for caregivers without tailoring to address this population’s unique psychosocial needs has not been studied. Objective: The goal of this trial is to determine what tailoring may be necessary for which caregivers to ensure they receive optimal benefit from an existing evidence-based, internet-delivered cognitive behavioral therapy for insomnia program named Sleep Healthy Using the Internet (SHUTi). Specifically, we will test the association between caregivers’ engagement with SHUTi and their caregiving context characteristics (ie, caregiving strain, self-efficacy, and guilt) and environment (ie, proximity to care recipient; functional status, cognitive status, and problem behavior of care recipient; and type of care provided). Among caregivers using the program, we will also test the associations between change in known treatment mechanisms (sleep beliefs and sleep locus of control) and caregiving context factors. Methods: A total of 100 higher-intensity caregivers with significant insomnia symptoms will be recruited from across the United States to receive access to SHUTi in an open-label trial with mixed methods preassessments and postassessments. At postassessment (9 weeks following preassessment completion), participants will be categorized according to their engagement with the program (nonusers, incomplete users, or complete users). Study analyses will address 3 specific aims: to examine the association between caregivers’ engagement with SHUTi and their caregiving context (aim 1a); to describe caregivers’ barriers to and motivations for SHUTi engagement from open-ended survey responses (aim 1b); and among caregivers using SHUTi, to determine whether cognitive mechanisms of change targeted by SHUTi are associated with differences in caregiving context (aim 2). Results: Institutional review board approvals have been received. Data collection is anticipated to begin in December 2021 and is expected to be completed in 2023. Conclusions: Findings will inform the next research steps for tailoring and testing SHUTi for optimal impact and reach among caregivers. Beyond implication to the SHUTi program, the findings will be translatable across intervention programs and will hold significant promise to reduce inefficiencies in developing digital health interventions for caregivers while also increasing their impact and reach for this underserved population. Trial Registration: ClinicalTrials.gov; NCT04986904; https://clinicaltrials.gov/ct2/show/NCT04986904?term=NCT04986904 International Registered Report Identifier (IRRID): PRR1-10.2196/34792 %M 35019846 %R 10.2196/34792 %U https://www.researchprotocols.org/2022/1/e34792 %U https://doi.org/10.2196/34792 %U http://www.ncbi.nlm.nih.gov/pubmed/35019846 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e27939 %T Effectiveness of Live Health Professional–Led Group eHealth Interventions for Adult Mental Health: Systematic Review of Randomized Controlled Trials %A Currie,Cheryl L %A Larouche,Richard %A Voss,M Lauren %A Trottier,Maegan %A Spiwak,Rae %A Higa,Erin %A Scott,David R %A Tallow,Treena %+ Faculty of Health Sciences, University of Lethbridge, 4401 University Drive, Lethbridge, AB, T1K 3M4, Canada, 1 4033324060, cheryl.currie@uleth.ca %K systematic review %K telemedicine %K eHealth %K mHealth %K e-therapy %K mobile interventions %K internet %K adult %K mental health %K anxiety %K depression %K substance use %K bereavement %K physical activity %K CBT %K psychotherapy %K group %K synchronous %K videoconference %K teleconference %D 2022 %7 11.1.2022 %9 Review %J J Med Internet Res %G English %X Background: The COVID-19 pandemic has had adverse impacts on mental health and substance use worldwide. Systematic reviews suggest eHealth interventions can be effective at addressing these problems. However, strong positive eHealth outcomes are often tied to the intensity of web-based therapist guidance, which has time and cost implications that can make the population scale-up of more effective interventions difficult. A way to offset cost while maintaining the intensity of therapist guidance is to offer eHealth programs to groups rather than more standard one-on-one formats. Objective: This systematic review aims to assess experimental evidence for the effectiveness of live health professional–led group eHealth interventions on mental health, substance use, or bereavement among community-dwelling adults. Within the articles selected for our primary aim, we also seek to examine the impact of interventions that encourage physical activity compared with those that do not. Methods: Overall, 4 databases (MEDLINE, CINAHL, PsycINFO, and the Cochrane Library) were searched in July 2020. Eligible studies were randomized controlled trials (RCTs) of eHealth interventions led by health professionals and delivered entirely to adult groups by videoconference, teleconference, or webchat. Eligible studies reported mental health, substance use, or bereavement as primary outcomes. The results were examined by outcome, eHealth platform, and intervention length. Postintervention data were used to calculate effect size by study. The findings were summarized using the Synthesis Without Meta-Analysis guidelines. Risk of bias was assessed using the Cochrane Collaboration Tool. Results: Of the 4099 identified studies, 21 (0.51%) RCTs representing 20 interventions met the inclusion criteria. These studies examined mental health outcomes among 2438 participants (sample size range: 47-361 participants per study) across 7 countries. When effect sizes were pooled, live health professional–led group eHealth interventions had a medium effect on reducing anxiety compared with inactive (Cohen d=0.57) or active control (Cohen d=0.48), a medium to small effect on reducing depression compared with inactive (Cohen d=0.61) or active control (Cohen d=0.21), and mixed effects on mental distress and coping. Interventions led by videoconference, and those that provided 8-12 hours of live health professional–led group contact had more robust effects on adult mental health. Risk of bias was high in 91% (19/21) of the studies. Heterogeneity across interventions was significant, resulting in low to very low quality of evidence. No eligible RCT was found that examined substance use, bereavement, or physical activity. Conclusions: Live eHealth group interventions led by health professionals can foster moderate improvements in anxiety and moderate to small improvements in depression among community-based adults, particularly those delivered by videoconference and those providing 8-12 hours of synchronous engagement. Trial Registration: PROSPERO CRD42020187551; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=187551 International Registered Report Identifier (IRRID): RR2-10.1186/s13643-020-01479-3 %M 34878409 %R 10.2196/27939 %U https://www.jmir.org/2022/1/e27939 %U https://doi.org/10.2196/27939 %U http://www.ncbi.nlm.nih.gov/pubmed/34878409 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 1 %P e27192 %T Effect of an Integrative Mobile Health Intervention in Patients With Hypertension and Diabetes: Crossover Study %A Oh,Sang Woo %A Kim,Kyoung-Kon %A Kim,Sung Soo %A Park,Su Kyung %A Park,Sangshin %+ Department of Family Medicine, Dongguk University Ilsan Hospital, Dongguk University College of Medicine, 27, Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, 10326, Republic of Korea, 82 31 961 7490, osw6021@naver.com %K diabetes mellitus type 2 %K obesity %K hypertension %K mHealth %K mobile phone %D 2022 %7 11.1.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Obesity, hypertension, and type 2 diabetes mellitus (T2DM) are worldwide epidemics that inflict burdens on both public health and health care costs. Self-management plays an important role in the proper management of these 3 chronic diseases, and in this context, mobile health (mHealth) can be a cost-effective self-management tool. Objective: The aim of this pilot study is to evaluate the effects of an integrative mHealth approach for obesity, hypertension, and T2DM on body fat, blood pressure, and blood glucose levels and demonstrate the clinical outcomes. The participants were patients aged 40 to 70 years who were treated for T2DM (hemoglobin A1c [HbA1c] above 6.0%) without insulin or hypertension and obesity, controlled with pharmacotherapy. Methods: This pilot study was performed using a controlled, randomized, 3-month, 2-period crossover design. A total of 37 participants were recruited from 2 university hospitals in South Korea. Integrative mHealth comprised 4 parts: self-measuring home devices for monitoring blood glucose and blood pressure; 2 smartphone apps, where one gathered lifestyle data, giving them feedback with health information, and the other provided drug information and reminders of the medication schedule; unmanned kiosks for official measurement of blood pressure and body composition; and web-based access to participants’ health information. Results: Data from the 32 participants were analyzed. Their mean HbA1c level was 7.5% (SD 0.8, ranging from 6.1% to 9.4%). Approximately 38% (12/32) of the participants had hypertension. BMIs of all participants except 1 were >23 kg/m2. The input rates of food intake and exercise to the smartphone app were very low (24.9% and 5.3%, respectively). On the contrary, the input rate of medicine intake was high (84.0%). Moreover, there was no significant difference in the input rate of taking medicine irrespective of whether the mHealth period was before or after the conventional treatment period (80.3% and 87.3%, respectively; P=.06). Among the 3 input functions of food intake, exercise, and medicine intake in smartphone apps, the input of medicine intake was a more helpful, easier to use, and better-designed function than the others. There were no significant differences in changes in body weight (−0.519 kg vs 0 kg), BMI (−0.133 kg/m2 vs −0.167 kg/m2), body composition (body fat −0.255% vs 0.172%), blood pressure (systolic −0.226 mm Hg vs −2.839 mm Hg), and HbA1c (−0.269% vs –0.009%) between the integrative mHealth and conventional treatment groups. However, in proportion to the elevation in the input rate of taking medicine, body fat mass (P=.04) and HbA1c (P=.03) were lower in the integrative mHealth group. Conclusions: Although smartphone apps can influence body fat and blood glucose levels, they have failed to show clinical improvement. A higher input rate of taking medicine was related to significantly lower body fat mass and HbA1c levels. %M 35014961 %R 10.2196/27192 %U https://mhealth.jmir.org/2022/1/e27192 %U https://doi.org/10.2196/27192 %U http://www.ncbi.nlm.nih.gov/pubmed/35014961 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e28230 %T Digital Intervention Strategies for Increasing Physical Activity Among Preschoolers: Systematic Review %A Swindle,Taren %A Poosala,Anwesh B %A Zeng,Nan %A Børsheim,Elisabet %A Andres,Aline %A Bellows,Laura L %+ Department of Pediatrics, University of Arkansas Medical Sciences, Little Rock, AR, United States, 1 8702360997, tswindle@uams.edu %K physical activity %K preschool children %K digital %K technology %K intervention %D 2022 %7 11.1.2022 %9 Review %J J Med Internet Res %G English %X Background: Digital interventions are increasingly used to improve health behaviors. Improved access and lower costs (relative to in-person interventions) make such interventions appealing. Specifically, digital platforms may be a promising approach for increasing physical activity (PA) in young children. Objective: The goal of this systematic review was three-pronged: (1) to determine the quality of studies using digital PA intervention strategies with preschool-aged children (ie, 3 to 5 years old); (2) to assess the efficacy of digital interventions and approaches designed to improve PA in preschool-aged children; and (3) to examine theoretical application and implementation outcomes with current approaches to digital PA interventions. Methods: This review identified and summarized studies on digitally supported interventions for promoting PA in preschool-aged children. We generated 3 lists of relevant search terms that included technology-related terms, PA-related terms, and weight-related terms. The search included Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, and Daily, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus. Study selection was led by a single author and verified by a second; the same 2 authors assessed study quality using a standardized tool, and 3 authors completed data extraction on PA outcomes, theory application, and implementation outcomes. Results: In total, 601 studies were identified; 8 met the inclusion criteria. For study quality, only 2 studies received an overall rating of strong quality and low risk of bias. All but 1 study had a small sample size (<100). Positive and significant changes in child PA outcomes were reported in only 2 studies with weak overall quality, both of which used child-directed approaches. In total, 5 studies applied a behavioral theory for designing the intervention; no patterns of effectiveness were identified based on the application of theory. Finally, no studies reported on the implementation outcomes of adoption, cost, penetration, or sustainability; 1 study did not assess any implementation outcomes, and no single study reported on more than 2 implementation outcomes. Studies measured the implementation outcome of acceptability most frequently (n=4), and researchers assessed fidelity in 3 studies. Conclusions: The interventions with a significant effect on PA used child-centered activities; parent-directed digital interventions alone were ineffective for improving PA. Future research with rigorous designs, monitoring of implementation outcomes, and testing of the contributions of digital components will advance understanding of the effectiveness of digital interventions for increasing PA in children. %M 35014962 %R 10.2196/28230 %U https://www.jmir.org/2022/1/e28230 %U https://doi.org/10.2196/28230 %U http://www.ncbi.nlm.nih.gov/pubmed/35014962 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 1 %P e27631 %T Combining Farmers’ Preferences With Evidence-Based Strategies to Prevent and Lower Farmers’ Distress: Co-design and Acceptability Testing of ifarmwell %A Gunn,Kate M %A Skaczkowski,Gemma %A Dollman,James %A Vincent,Andrew D %A Short,Camille E %A Brumby,Susan %A Barrett,Alison %A Harrison,Nathan %A Turnbull,Deborah %+ Department of Rural Health, Allied Health and Human Performance, University of South Australia, City East Campus BJ2-03, North Terrace, Adelaide, 5001, Australia, 61 417852537, kate.gunn@unisa.edu.au %K farm %K agriculture %K rural %K drought %K mental health %K stress %K coping %K online intervention %K acceptance and commitment therapy %D 2022 %7 11.1.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Farming is physically and psychologically hazardous. Farmers face many barriers to help seeking from traditional physical and mental health services; however, improved internet access now provides promising avenues for offering support. Objective: This study aims to co-design with farmers the content and functionality of a website that helps them adopt transferable coping strategies and test its acceptability in the broader farming population. Methods: Research evidence and expert opinions were synthesized to inform key design principles. A total of 18 farmers detailed what they would like from this type of website. Intervention logic and relevant evidence-based strategies were mapped. Website content was drafted and reviewed by 2 independent mental health professionals. A total of 9 farmers provided detailed qualitative feedback on the face validity of the draft content. Subsequently, 9 farmers provided feedback on the website prototype. Following amendments and internal prototype testing and optimization, prototype usability (ie, completion rate) was examined with 157 registered website users who were (105/157, 66.9%) female, aged 21-73 years; 95.5% (149/156) residing in inner regional to very remote Australia, and 68.2% (107/157) “sheep, cattle and/or grain farmers.” Acceptability was examined with a subset of 114 users who rated at least module 1. Interviews with 108 farmers who did not complete all 5 modules helped determine why, and detailed interviews were conducted with 18 purposively sampled users. Updates were then made according to adaptive trial design methodology. Results: This systematic co-design process resulted in a web-based resource based on acceptance and commitment therapy and designed to overcome barriers to engagement with traditional mental health and well-being strategies—ifarmwell. It was considered an accessible and confidential source of practical and relevant farmer-focused self-help strategies. These strategies were delivered via 5 interactive modules that include written, drawn, and audio- and video-based psychoeducation and exercises, as well as farming-related jokes, metaphors, examples, and imagery. Module 1 included distress screening and information on how to speak to general practitioners about mental health–related concerns (including a personalized conversation script). Modules were completed fortnightly. SMS text messages offered personalized support and reminders. Qualitative interviews and star ratings demonstrated high module acceptability (average 4.06/5 rating) and suggested that additional reminders, higher quality audio recordings, and shorter modules would be useful. Approximately 37.1% (52/140) of users who started module 1 completed all modules, with too busy or not got to it yet being the main reason for non-completion, and previous module acceptability not predicting subsequent module completion. Conclusions: Sequential integration of research evidence, expert knowledge, and farmers’ preferences in the co-design process allowed for the development of a self-help intervention that focused on important intervention targets and was acceptable to this difficult-to-engage group. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12617000506392; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372526 %M 35014963 %R 10.2196/27631 %U https://humanfactors.jmir.org/2022/1/e27631 %U https://doi.org/10.2196/27631 %U http://www.ncbi.nlm.nih.gov/pubmed/35014963 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 1 %P e33438 %T Patients’ Expectations and Experiences With a Mental Health–Focused Supportive Text Messaging Program: Mixed Methods Evaluation %A Shalaby,Reham %A Vuong,Wesley %A Eboreime,Ejemai %A Surood,Shireen %A Greenshaw,Andrew J %A Agyapong,Vincent Israel Opoku %+ Department of Psychiatry, University of Alberta, 1E1 Walter Mackenzie Health Sciences Centre (WMC), 8440 112 St NW, Edmonton, AB, T6G 2B7, Canada, 1 17807144315, vincent.agyapong@nshealth.ca %K supportive text messages %K patients’ experience %K mental health %K mixed methods %D 2022 %7 11.1.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Web-based services are an economical and easily scalable means of support that uses existing technology. Text4Support is a supportive, complementary text messaging service that supports people with different mental health conditions after they are discharged from inpatient psychiatric care. Objective: In this study, we aim to assess user satisfaction with the Text4Support service to gain a better understanding of subscribers’ experiences. Methods: This was a mixed methods study using secondary data from a pilot observational controlled trial. The trial included 181 patients discharged from acute psychiatric care and distributed into 4 randomized groups. Out of the 4 study groups in the initial study, 2 groups who received supportive text messages (89/181, 49.2% of patients), either alone or alongside a peer support worker, were included. Thematic and descriptive analyses were also performed. Differences in feedback based on sex at birth and primary diagnosis were determined using univariate analysis. The study was registered with ClinicalTrials.gov (trial registration number: NCT03404882). Results: Out of 89 participants, 36 (40%) completed the follow-up survey. The principal findings were that Text4Support was well perceived with a high satisfaction rate either regarding the feedback of the messages or their perceived impact. Meanwhile, there was no statistically significant difference between satisfactory items based on the subscriber’s sex at birth or primary diagnosis. The patients’ initial expectations were either neutral or positive in relation to the expected nature or the impact of the text messages received on their mental well-being. In addition, the subscribers were satisfied with the frequency of the messages, which were received once daily for 6 consecutive months. The participants recommended more personalized messages or mutual interaction with health care personnel. Conclusions: Text4Support was generally well perceived by patients after hospital discharge, regardless of their sex at birth or mental health diagnosis. Further personalization and interactive platforms were recommended by participants that may need to be considered when designing similar future services. %M 35014972 %R 10.2196/33438 %U https://formative.jmir.org/2022/1/e33438 %U https://doi.org/10.2196/33438 %U http://www.ncbi.nlm.nih.gov/pubmed/35014972 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e29302 %T Users’ Experiences With the NoHoW Web-Based Toolkit With Weight and Activity Tracking in Weight Loss Maintenance: Long-term Randomized Controlled Trial %A Mattila,Elina %A Hansen,Susanne %A Bundgaard,Lise %A Ramsey,Lauren %A Dunning,Alice %A Silva,Marlene N %A Harjumaa,Marja %A Ermes,Miikka %A Marques,Marta M %A Matos,Marcela %A Larsen,Sofus C %A Encantado,Jorge %A Santos,Inês %A Horgan,Graham %A O'Driscoll,Ruairi %A Turicchi,Jake %A Duarte,Cristiana %A Palmeira,António L %A Stubbs,R James %A Heitmann,Berit Lilienthal %A Lähteenmäki,Liisa %+ VTT Technical Research Centre of Finland Ltd, Tekniikantie 21, Espoo, 02150, Finland, 358 407162230, elina.m.mattila@vtt.fi %K digital behavior change intervention %K user experience %K technology acceptance %K weight-loss maintenance %K focus groups %K mixed methods %K mobile phone %D 2022 %7 10.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital behavior change interventions (DBCIs) offer a promising channel for providing health promotion services. However, user experience largely determines whether they are used, which is a precondition for effectiveness. Objective: The primary aim of this study is to evaluate user experiences with the NoHoW Toolkit (TK)—a DBCI that targets weight loss maintenance—over a 12-month period by using a mixed methods approach and to identify the main strengths and weaknesses of the TK and the external factors affecting its adoption. The secondary aim is to objectively describe the measured use of the TK and its association with user experience. Methods: An 18-month, 2×2 factorial randomized controlled trial was conducted. The trial included 3 intervention arms receiving an 18-week active intervention and a control arm. The user experience of the TK was assessed quantitatively through electronic questionnaires after 1, 3, 6, and 12 months of use. The questionnaires also included open-ended items that were thematically analyzed. Focus group interviews were conducted after 6 months of use and thematically analyzed to gain deeper insight into the user experience. Log files of the TK were used to evaluate the number of visits to the TK, the total duration of time spent in the TK, and information on intervention completion. Results: The usability level of the TK was rated as satisfactory. User acceptance was rated as modest; this declined during the trial in all the arms, as did the objectively measured use of the TK. The most appreciated features were weekly emails, graphs, goal setting, and interactive exercises. The following 4 themes were identified in the qualitative data: engagement with features, decline in use, external factors affecting user experience, and suggestions for improvements. Conclusions: The long-term user experience of the TK highlighted the need to optimize the technical functioning, appearance, and content of the DBCI before and during the trial, similar to how a commercial app would be optimized. In a trial setting, the users should be made aware of how to use the intervention and what its requirements are, especially when there is more intensive intervention content. Trial Registration: ISRCTN Registry ISRCTN88405328; https://www.isrctn.com/ISRCTN88405328 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2019-029425 %M 35006081 %R 10.2196/29302 %U https://www.jmir.org/2022/1/e29302 %U https://doi.org/10.2196/29302 %U http://www.ncbi.nlm.nih.gov/pubmed/35006081 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e22957 %T The Impact of Synchronous Telehealth Services With a Digital Platform on Day-by-Day Home Blood Pressure Variability in Patients with Cardiovascular Diseases: Retrospective Cohort Study %A Chen,Ying-Hsien %A Hung,Chi-Sheng %A Huang,Ching-Chang %A Lee,Jen-Kuang %A Yu,Jiun-Yu %A Ho,Yi-Lwun %+ Department of Internal Medicine, National Taiwan University Hospital, #7, Chung-Shan South Road, Taipei, 100225, Taiwan, 886 2 23123456 ext 65524, ylho@ntu.edu.tw %K blood pressure %K variability %K telehealth %K hypertension %K cardiovascular disease %K chronic disease %K heart %K digital platform %K cohort %K management %K intervention %D 2022 %7 10.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Hypertension is associated with a large global disease burden with variable control rates across different regions and races. Telehealth has recently emerged as a health care strategy for managing chronic diseases, but there are few reports regarding the effects of synchronous telehealth services on home blood pressure (BP) control and variability. Objective: The objective of this study is to investigate the effect of synchronous telehealth services with a digital platform on home BP. Methods: This retrospective study was conducted by the Taiwan ELEctroHEALTH study group at the Telehealth Center of the National Taiwan University Hospital. We analyzed home BP data taken from 2888 patients with cardiovascular disease (CVD) enrolled in our telehealth program between 2009 to 2017. Of the 2888 patients with CVD, 348 (12.05%) patients who received home BP surveillance for ≥56 days were selected for BP analysis. Patients were stratified into three groups: (1) poorly controlled hypertension, (2) well-controlled hypertension, and (3) nonhypertension. The mean, SD, coefficient of variation (CV), and average real variability were calculated. Results: Telehealth interventions significantly and steadily reduced systolic blood pressure (SBP) in the poorly controlled hypertension group from 144.8.2±9.2 to 133.7±10.2 mmHg after 2 months (P<.001). BP variability reduced in all patients: SBP-SD decreased from 7.8±3.4 to 7.3±3.4 after 2 months (P=.004), and SBP-CV decreased from 6.3±2.5 to 5.9±2.6 after 2 months (P=.004). Event-free survival (admission) analysis stratified by SBP-SD showed longer time to first hospitalization for Q1 patients compared with Q4 patients (P=.02, odds ratio 2.15, 95% CI 1.18-3.89). Conclusions: Synchronous telehealth intervention may improve home BP control and decrease day-by-day home BP variability in patients with CVD. %M 35006089 %R 10.2196/22957 %U https://www.jmir.org/2022/1/e22957 %U https://doi.org/10.2196/22957 %U http://www.ncbi.nlm.nih.gov/pubmed/35006089 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 1 %P e26526 %T Use of a Mobile Peer Support App Among Young People With Nonsuicidal Self-injury: Small-scale Randomized Controlled Trial %A Kruzan,Kaylee Payne %A Whitlock,Janis %A Bazarova,Natalya N %A Bhandari,Aparajita %A Chapman,Julia %+ Center for Behavioral Intervention Technologies, Northwestern University, 750 N Lake Shore Drive, Chicago, IL, 60611, United States, 1 312 503 6585, kaylee.kruzan@northwestern.edu %K nonsuicidal self-injury %K randomized controlled trial %K mobile app %K peer support %K urges %K digital intervention %D 2022 %7 10.1.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Nonsuicidal self-injury (NSSI) is a widespread behavior among adolescents and young adults. Although many individuals who self-injure do not seek treatment, there is evidence for web-based help-seeking through web-based communities and mobile peer support networks. However, few studies have rigorously tested the efficacy of such platforms on outcomes relevant for NSSI recovery. Objective: The aim of this small-scale preregistered randomized controlled trial is to provide preliminary insight into the shorter- and longer-term efficacy of the use of a peer support app, TalkLife, in reducing NSSI frequency and urges and increasing readiness to change. In addition, we explore contact with informal support, interest in therapy, and attitudes toward professional help–seeking. Methods: Individuals aged 16-25 years with current (within 3 months) and chronic (>6 episodes in the past year) NSSI history were eligible to participate in this study. After baseline assessments, the intervention group was instructed to use the app actively (eg, post or comment at least three times per week) and the control group received weekly psychoeducational materials through email, for 8 weeks. Follow-up was assessed at 1 month and 2 months. Linear mixed modeling was used to evaluate condition and time point effects for the primary outcomes of NSSI frequency and urges, readiness to change, contact with informal support, interest in therapy, and attitudes toward professional help–seeking. Results: A total of 131 participants were included in the analysis. We evidenced a significant effect of condition on NSSI frequency such that the participants using the peer support app self-injured less over the course of the study (mean 1.30, SE 0.18) than those in the control condition (mean 1.62, SE 0.18; P=.02; η2=0.02). We also evidenced a significant condition effect of readiness to change such that the treatment participants reported greater confidence in their ability to change their NSSI behavior (mean 6.28, SE 0.41) than the control participants (mean 5.67, SE 0.41; P=.04; η2=0.02). No significant differences were observed for contact with informal support, interest in therapy, or attitudes toward professional help–seeking. Conclusions: Use of the peer support app was related to reduced NSSI frequency and greater confidence in one’s ability to change NSSI behavior over the course of the study period, but no effects on NSSI urges, contact with informal support, interest in therapy, or attitudes toward professional help–seeking were observed. The findings provide preliminary support for considering the use of mobile peer support apps as a supplement to NSSI intervention and point to the need for larger-scale trials. Trial Registration: Open Science Foundation; https://osf.io/3uay9 %M 35006076 %R 10.2196/26526 %U https://formative.jmir.org/2022/1/e26526 %U https://doi.org/10.2196/26526 %U http://www.ncbi.nlm.nih.gov/pubmed/35006076 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e25419 %T Designing Effective eHealth Interventions for Underserved Groups: Five Lessons From a Decade of eHealth Intervention Design and Deployment %A Lee,Edmund WJ %A McCloud,Rachel F %A Viswanath,Kasisomayajula %+ Wee Kim Wee School of Communication and Information, Nanyang Technological University, 31 Nanyang Link, Wee Kim Wee School of Communication and Information Building, Singapore, 637718, Singapore, 65 69083429, elwj88@gmail.com %K eHealth %K mobile health %K communication inequalities %K health disparities %K health informatics %K mobile phone %D 2022 %7 7.1.2022 %9 Viewpoint %J J Med Internet Res %G English %X Despite the proliferation of eHealth interventions, such as web portals, for health information dissemination or the use of mobile apps and wearables for health monitoring, research has shown that underserved groups do not benefit proportionately from these eHealth interventions. This is largely because of usability issues and the lack of attention to the broader structural, physical, and psychosocial barriers to technology adoption and use. The objective of this paper is to draw lessons from a decade of experience in designing different user-centered eHealth interventions (eg, web portals and health apps) to inform future work in leveraging technology to address health disparities. We draw these lessons from a series of interventions from the work we have done over 15 years in the Viswanath laboratory at the Dana-Farber Cancer Institute and Harvard TH Chan School of Public Health, focusing on three projects that used web portals and health apps targeted toward underserved groups. The projects were the following: Click to Connect, which was a community-based eHealth intervention that aimed to improve internet skills and health literacy among underserved groups by providing home access to high-speed internet, computer, and internet training classes, as well as a dedicated health web portal with ongoing technical support; PLANET MassCONECT, which was a knowledge translation project that built capacity among community-based organizations in Boston, Lawrence, and Worcester in Massachusetts to adopt evidence-based health promotion programs; and Smartphone App for Public Health, which was a mobile health research that facilitated both participatory (eg, surveys) and passive data (eg, geolocations and web-browsing behaviors) collection for the purpose of understanding tobacco message exposure in individuals’ built environment. Through our work, we distilled five key principles for researchers aiming to design eHealth interventions for underserved groups. They are as follows: develop a strategic road map to address communication inequalities (ie, a concrete action plan to identify the barriers faced by underserved groups and customize specific solutions to each of them), engage multiple stakeholders from the beginning for the long haul, design with usability—readability and navigability—in mind, build privacy safeguards into eHealth interventions and communicate privacy–utility tradeoffs in simplicity, and strive for an optimal balance between open science aspirations and protection of underserved groups. %M 34994700 %R 10.2196/25419 %U https://www.jmir.org/2022/1/e25419 %U https://doi.org/10.2196/25419 %U http://www.ncbi.nlm.nih.gov/pubmed/34994700 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e33348 %T Digital Behavior Change Interventions for the Prevention and Management of Type 2 Diabetes: Systematic Market Analysis %A Keller,Roman %A Hartmann,Sven %A Teepe,Gisbert Wilhelm %A Lohse,Kim-Morgaine %A Alattas,Aishah %A Tudor Car,Lorainne %A Müller-Riemenschneider,Falk %A von Wangenheim,Florian %A Mair,Jacqueline Louise %A Kowatsch,Tobias %+ Future Health Technologies Programme, Campus for Research Excellence and Technological Enterprise, Singapore-ETH Centre, 1 Create Way, CREATE Tower, #06-01, Singapore, 138602, Singapore, 65 82645302, roman.keller@sec.ethz.ch %K digital health companies %K health care %K type 2 diabetes %K prevention %K management %K conversational agent %K digital behavior change intervention %K investment %K just-in-time adaptive intervention %K digital health %K diabetes %K agent %K behavior %D 2022 %7 7.1.2022 %9 Review %J J Med Internet Res %G English %X Background: Advancements in technology offer new opportunities for the prevention and management of type 2 diabetes. Venture capital companies have been investing in digital diabetes companies that offer digital behavior change interventions (DBCIs). However, little is known about the scientific evidence underpinning such interventions or the degree to which these interventions leverage novel technology-driven automated developments such as conversational agents (CAs) or just-in-time adaptive intervention (JITAI) approaches. Objective: Our objectives were to identify the top-funded companies offering DBCIs for type 2 diabetes management and prevention, review the level of scientific evidence underpinning the DBCIs, identify which DBCIs are recognized as evidence-based programs by quality assurance authorities, and examine the degree to which these DBCIs include novel automated approaches such as CAs and JITAI mechanisms. Methods: A systematic search was conducted using 2 venture capital databases (Crunchbase Pro and Pitchbook) to identify the top-funded companies offering interventions for type 2 diabetes prevention and management. Scientific publications relating to the identified DBCIs were identified via PubMed, Google Scholar, and the DBCIs’ websites, and data regarding intervention effectiveness were extracted. The Diabetes Prevention Recognition Program (DPRP) of the Center for Disease Control and Prevention in the United States was used to identify the recognition status. The DBCIs’ publications, websites, and mobile apps were reviewed with regard to the intervention characteristics. Results: The 16 top-funded companies offering DBCIs for type 2 diabetes received a total funding of US $2.4 billion as of June 15, 2021. Only 4 out of the 50 identified publications associated with these DBCIs were fully powered randomized controlled trials (RCTs). Further, 1 of those 4 RCTs showed a significant difference in glycated hemoglobin A1c (HbA1c) outcomes between the intervention and control groups. However, all the studies reported HbA1c improvements ranging from 0.2% to 1.9% over the course of 12 months. In addition, 6 interventions were fully recognized by the DPRP to deliver evidence-based programs, and 2 interventions had a pending recognition status. Health professionals were included in the majority of DBCIs (13/16, 81%,), whereas only 10% (1/10) of accessible apps involved a CA as part of the intervention delivery. Self-reports represented most of the data sources (74/119, 62%) that could be used to tailor JITAIs. Conclusions: Our findings suggest that the level of funding received by companies offering DBCIs for type 2 diabetes prevention and management does not coincide with the level of evidence on the intervention effectiveness. There is considerable variation in the level of evidence underpinning the different DBCIs and an overall need for more rigorous effectiveness trials and transparent reporting by quality assurance authorities. Currently, very few DBCIs use automated approaches such as CAs and JITAIs, limiting the scalability and reach of these solutions. %M 34994693 %R 10.2196/33348 %U https://www.jmir.org/2022/1/e33348 %U https://doi.org/10.2196/33348 %U http://www.ncbi.nlm.nih.gov/pubmed/34994693 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 1 %P e31482 %T App-Based Relaxation Exercises for Patients With Chronic Neck Pain: Pragmatic Randomized Trial %A Pach,Daniel %A Blödt,Susanne %A Wang,Jiani %A Keller,Theresa %A Bergmann,Beatrice %A Rogge,Alizé A %A Barth,Jürgen %A Icke,Katja %A Roll,Stephanie %A Witt,Claudia M %+ Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Sonneggstrasse 6, Zurich, 8091, Switzerland, 41 44 2552396, claudia.witt@uzh.ch %K neck pain %K relaxation %K RCT %K mHealth %K smartphone app %K mobile phone %D 2022 %7 7.1.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Chronic neck pain is a highly prevalent condition. Learning a relaxation technique is recommended by numerous guidelines for chronic neck pain. Smartphone apps can provide relaxation exercises; however, their effectiveness, especially in a self-care setting, is unclear. Objective: The aim of this pragmatic randomized trial is to evaluate whether app-based relaxation exercises, including audio-based autogenic training, mindfulness meditation, or guided imagery, are more effective in reducing chronic neck pain than usual care alone. Methods: Smartphone owners aged 18 to 65 years with chronic (>12 weeks) neck pain and the previous week’s average neck pain intensity ≥4 on the Numeric Rating Scale (0=no pain to 10=worst possible pain) were randomized into either an intervention group to practice app-based relaxation exercises or a control group (usual care and app for data entry only). For both groups, the follow-up data were collected using app-based diaries and questionnaires. The primary outcome was the mean neck pain intensity during the first 3 months based on daily measurements. Secondary outcomes included neck pain based on weekly measurements, pain acceptance, neck pain–related stress, sick-leave days, pain medication intake, and adherence, which were all measured until the 6-month follow-up. For the primary analysis, analysis of covariance adjusted for baseline neck pain intensity was used. Results: We screened 748 participants and enrolled 220 participants (mean age 38.9, SD 11.3 years; mean baseline neck pain 5.7, SD 1.3 points). The mean neck pain intensity in both groups decreased over 3 months; however, no statistically significant difference between the groups was found (intervention: 4.1 points, 95% CI 3.8-4.4; control: 3.8 points, 95% CI 3.5-4.1; group difference: 0.3 points, 95% CI −0.2 to 0.7; P=.23). In addition, no statistically significant between-group differences regarding neck pain intensity after 6 months, responder rate, pain acceptance, pain medication intake, or sick-leave days were observed. There were no serious adverse events that were considered related to the trial intervention. In week 12, only 40% (44/110) of the participants in the intervention group continued to practice the exercises with the app. Conclusions: The study app did not effectively reduce chronic neck pain or keep the participants engaged in exercising in a self-care setting. Future studies on app-based relaxation interventions should take into account the most recent scientific findings for behavior change techniques. Trial Registration: ClinicalTrials.gov NCT02019134; https://clinicaltrials.gov/ct2/show/NCT02019134 International Registered Report Identifier (IRRID): RR2-10.1186/1745-6215-15-490 %M 34994708 %R 10.2196/31482 %U https://mhealth.jmir.org/2022/1/e31482 %U https://doi.org/10.2196/31482 %U http://www.ncbi.nlm.nih.gov/pubmed/34994708 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 1 %P e34530 %T A Web-Based Alcohol and Other Drug Prevention Program (Strong & Deadly Futures) for Aboriginal and Torres Strait Islander School Students: Protocol for a Cluster Randomized Controlled Trial %A Stapinski,Lexine %A Routledge,Kylie %A Snijder,Mieke %A Doyle,Michael %A Champion,Katrina %A Chapman,Cath %A Ward,James %A Baumgart,Amanda %A Lee,K S Kylie %A Teesson,Maree %A Newton,Nicola %+ The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Lvl 6, Jane Foss Russell Building G02, Darlington, 2006, Australia, 61 286279039, lexine.stapinski@sydney.edu.au %K Aboriginal and Torres Strait Islander %K prevention %K alcohol %K tobacco %K substance use %K universal prevention %K well-being %K harm minimization %K Indigenous %K web-based %D 2022 %7 7.1.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: There are no available school-based alcohol and drug prevention programs with evidence of effectiveness among Aboriginal and Torres Strait Islander youth. To address this, we codeveloped the Strong & Deadly Futures well-being and alcohol and drug prevention program in partnership with an Indigenous creative design agency and 4 Australian schools. Objective: This paper presents the protocol to evaluate the effectiveness of Strong & Deadly Futures in reducing alcohol and other drug use and improving well-being among Aboriginal and Torres Strait Islander youth. Methods: The target sample will be 960 year 7 and 8 students from 24 secondary schools in Australia, of which approximately 40% (384/960) will identify as Aboriginal or Torres Strait Islander. The study design is a 2-group, parallel cluster randomized controlled trial with allocation concealment. Recruited schools will be block randomized (ratio 1:1), stratified by geographical remoteness, by an independent statistician. Schools will be randomized to receive Strong & Deadly Futures, a web-based alcohol and drug prevention and social and emotional well-being program that delivers curriculum-aligned content over 6 lessons via an illustrated story, or health education as usual (control). Control schools will be supported to implement Strong & Deadly Futures following trial completion. Surveys will be administered at baseline, 6 weeks, 12 months, and 24 months (primary end point) post baseline. Primary outcomes are alcohol use (adapted from the National Drug Strategy Household Survey), tobacco use (Standard High School Youth Risk Behavior Survey), and psychological distress (Kessler-5 Psychological Distress Scale). Secondary outcomes are alcohol and drug knowledge and intentions, alcohol-related harms, binge drinking, cannabis use, well-being, empowerment, appreciation of cultural diversity, and truancy. Results: The trial was funded by the National Health and Medical Research Council in January 2019, approved by the Human Research Ethics Committee of the University of Sydney (2020/039, April 2020), the Aboriginal Health and Medical Research Council of New South Wales (1620/19, February 2020), the Western Australian Aboriginal Health Ethics Committee (998, October 2021), and the ethics committees of each participating school, including the New South Wales Department of Education (2020170, June 2020), Catholic Education Western Australia (RP2020/39, November 2020), and the Queensland Department of Education (550/27/2390, August 2021). Projected dates of data collection are 2022-2024, and we expect to publish the results in 2025. A total of 24 schools have been recruited as of submission of the manuscript. Conclusions: This will be the first cluster randomized controlled trial of a culturally inclusive, school-based alcohol and drug prevention program for Aboriginal and Torres Strait Islander youth; therefore, it has significant potential to address alcohol and other drug harms among Aboriginal and Torres Strait Islander youth. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620001038987; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380038&isReview=true International Registered Report Identifier (IRRID): PRR1-10.2196/34530 %M 34994696 %R 10.2196/34530 %U https://www.researchprotocols.org/2022/1/e34530 %U https://doi.org/10.2196/34530 %U http://www.ncbi.nlm.nih.gov/pubmed/34994696 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e30077 %T Effectiveness of Digital Counseling Environments on Anxiety, Depression, and Adherence to Treatment Among Patients Who Are Chronically Ill: Systematic Review %A Paalimäki-Paakki,Karoliina %A Virtanen,Mari %A Henner,Anja %A Nieminen,Miika T %A Kääriäinen,Maria %+ Research Unit of Nursing Science and Health Management, University of Oulu, Aapistie 5 A, Oulu, 90220, Finland, 358 505365959, karoliina.paalimaki-paakki@oamk.fi %K mHealth %K mobile health %K eHealth %K digital health %K mobile apps %K smartphone apps %K web-based %K telemedicine %K chronic diseases %K noncommunicable diseases %K web-based interventions %K mobile phone %D 2022 %7 6.1.2022 %9 Review %J J Med Internet Res %G English %X Background: Patients who are chronically ill need novel patient counseling methods to support their self-care at different stages of the disease. At present, knowledge of how effective digital counseling is at managing patients’ anxiety, depression, and adherence to treatment seems to be fragmented, and the development of digital counseling will require a more comprehensive view of this subset of interventions. Objective: This study aims to identify and synthesize the best available evidence on the effectiveness of digital counseling environments at improving anxiety, depression, and adherence to treatment among patients who are chronically ill. Methods: Systematic searches of the EBSCO (CINAHL), PubMed, Scopus, and Web of Science databases were conducted in May 2019 and complemented in October 2020. The review considered studies that included adult patients aged ≥18 years with chronic diseases; interventions evaluating digital (mobile, web-based, and ubiquitous) counseling interventions; and anxiety, depression, and adherence to treatment, including clinical indicators related to adherence to treatment, as outcomes. Methodological quality was assessed using the standardized Joanna Briggs Institute critical appraisal tool for randomized controlled trials or quasi-experimental studies. As a meta-analysis could not be conducted because of considerable heterogeneity in the reported outcomes, narrative synthesis was used to synthesize the results. Results: Of the 2056 records screened, 20 (0.97%) randomized controlled trials, 4 (0.19%) pilot randomized controlled trials, and 2 (0.09%) quasi-experimental studies were included. Among the 26 included studies, 10 (38%) digital, web-based interventions yielded significantly positive effects on anxiety, depression, adherence to treatment, and the clinical indicators related to adherence to treatment, and another 18 (69%) studies reported positive, albeit statistically nonsignificant, changes among patients who were chronically ill. The results indicate that an effective digital counseling environment comprises high-quality educational materials that are enriched with multimedia elements and activities that engage the participant in self-care. Because of the methodological heterogeneity of the included studies, it is impossible to determine which type of digital intervention is the most effective for managing anxiety, depression, and adherence to treatment. Conclusions: This study provides compelling evidence that digital, web-based counseling environments for patients who are chronically ill are more effective than, or at least comparable to, standard counseling methods; this suggests that digital environments could complement standard counseling. %M 34989681 %R 10.2196/30077 %U https://www.jmir.org/2022/1/e30077 %U https://doi.org/10.2196/30077 %U http://www.ncbi.nlm.nih.gov/pubmed/34989681 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e28368 %T A New Remote Guided Method for Supervised Web-Based Cognitive Testing to Ensure High-Quality Data: Development and Usability Study %A Leong,Victoria %A Raheel,Kausar %A Sim,Jia Yi %A Kacker,Kriti %A Karlaftis,Vasilis M %A Vassiliu,Chrysoula %A Kalaivanan,Kastoori %A Chen,S H Annabel %A Robbins,Trevor W %A Sahakian,Barbara J %A Kourtzi,Zoe %+ Psychology, School of Social Sciences, Nanyang Technological University, 48 Nanyang Avenue, Singapore, 639818, Singapore, 65 6514 1052, victorialeong@ntu.edu.sg %K web-based testing %K neurocognitive assessment %K COVID-19 %K executive functions %K learning %D 2022 %7 6.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The global COVID-19 pandemic has triggered a fundamental reexamination of how human psychological research can be conducted safely and robustly in a new era of digital working and physical distancing. Online web-based testing has risen to the forefront as a promising solution for the rapid mass collection of cognitive data without requiring human contact. However, a long-standing debate exists over the data quality and validity of web-based studies. This study examines the opportunities and challenges afforded by the societal shift toward web-based testing and highlights an urgent need to establish a standard data quality assurance framework for online studies. Objective: This study aims to develop and validate a new supervised online testing methodology, remote guided testing (RGT). Methods: A total of 85 healthy young adults were tested on 10 cognitive tasks assessing executive functioning (flexibility, memory, and inhibition) and learning. Tasks were administered either face-to-face in the laboratory (n=41) or online using remote guided testing (n=44) and delivered using identical web-based platforms (Cambridge Neuropsychological Test Automated Battery, Inquisit, and i-ABC). Data quality was assessed using detailed trial-level measures (missed trials, outlying and excluded responses, and response times) and overall task performance measures. Results: The results indicated that, across all data quality and performance measures, RGT data was statistically-equivalent to in-person data collected in the lab (P>.40 for all comparisons). Moreover, RGT participants out-performed the lab group on measured verbal intelligence (P<.001), which could reflect test environment differences, including possible effects of mask-wearing on communication. Conclusions: These data suggest that the RGT methodology could help ameliorate concerns regarding online data quality—particularly for studies involving high-risk or rare cohorts—and offer an alternative for collecting high-quality human cognitive data without requiring in-person physical attendance. %M 34989691 %R 10.2196/28368 %U https://www.jmir.org/2022/1/e28368 %U https://doi.org/10.2196/28368 %U http://www.ncbi.nlm.nih.gov/pubmed/34989691 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 1 %P e30408 %T Game Plan—a Brief Web-Based Intervention to Improve Uptake and Use of HIV Pre-exposure Prophylaxis (PrEP) and Reduce Alcohol Use Among Gay and Bisexual Men: Content Analysis %A Wray,Tyler B %A Chan,Philip A %A Guigayoma,John P %A Kahler,Christopher W %+ Department of Behavioral and Social Sciences, School of Public Health, Brown University, 121 S. Main Street, Box G-S121-5, Providence, RI, 02903, United States, 1 4018636659, tyler_wray@brown.edu %K HIV %K pre-exposure prophylaxis %K alcohol use %K mHealth %K eHealth %K intervention %K mobile phone %D 2022 %7 5.1.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: HIV pre-exposure prophylaxis (PrEP) has considerable potential for reducing incidence among high-risk groups, such as gay, bisexual, and other men who have sex with men (GBM). However, PrEP’s effectiveness is closely linked with consistent use, and a variety of individual-level barriers, including alcohol use, could impede optimal uptake and use. Web-based interventions can encourage medication adherence, HIV prevention behaviors, and responsible drinking and may help support PrEP care, particularly in resource-limited settings. Objective: We previously developed a web application called Game Plan that was designed to encourage heavy drinking GBM to use HIV prevention methods and reduce their alcohol use and was inspired by brief motivational interventions. This paper aims to describe the web-based content we designed for integration into Game Plan to help encourage PrEP uptake and consistent use among GBM. In this paper, we also aim to describe this content and its rationale. Methods: Similar to the original site, these components were developed iteratively, guided by a thorough user-centered design process involving consultation with subject-matter experts, usability interviews and surveys, and user experience surveys. Results: In addition to Game Plan’s pre-existing content, the additional PrEP components provide specific, personal, and digestible feedback to users about their level of risk for HIV without PrEP and illustrate how much consistent PrEP use could reduce it; personal feedback about their risk for common sexually transmitted infections to address low-risk perceptions; content challenging common beliefs and misconceptions about PrEP to reduce stigma; content confronting familiar PrEP and alcohol beliefs; and a change planning module that allows users to select specific goals for starting and strategies for consistent PrEP use. Users can opt into a weekly 2-way SMS text messaging program that provides similar feedback over a 12-week period after using Game Plan and follows up on the goals they set. Conclusions: Research preliminarily testing the efficacy of these components in improving PrEP outcomes, including uptake, adherence, sexually transmitted infection rates, and alcohol use, is currently ongoing. If supported, these components could provide a scalable tool that can be used in resource-limited settings in which face-to-face intervention is difficult. %M 34989679 %R 10.2196/30408 %U https://formative.jmir.org/2022/1/e30408 %U https://doi.org/10.2196/30408 %U http://www.ncbi.nlm.nih.gov/pubmed/34989679 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 1 %P e25586 %T Dose–Response Effects of Patient Engagement on Health Outcomes in an mHealth Intervention: Secondary Analysis of a Randomized Controlled Trial %A Li,Yiran %A Guo,Yan %A Hong,Y Alicia %A Zeng,Yu %A Monroe-Wise,Aliza %A Zeng,Chengbo %A Zhu,Mengting %A Zhang,Hanxi %A Qiao,Jiaying %A Xu,Zhimeng %A Cai,Weiping %A Li,Linghua %A Liu,Cong %+ Department of Medical Statistics, School of Public Health, 74 Zhongshan 2nd Road, Guangzhou, 510080, China, 86 020 87333239, Yan.Guo1@umassmed.edu %K mHealth %K patient engagement %K dose–response relationship %K long-term effect %K generalized linear mixed effects model %D 2022 %7 4.1.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The dose–response relationship between patient engagement and long-term intervention effects in mobile health (mHealth) interventions are understudied. Studies exploring long-term and potentially changing relationships between patient engagement and health outcomes in mHealth interventions are needed. Objective: This study aims to examine dose–response relationships between patient engagement and 3 psychosocial outcomes in an mHealth intervention, Run4Love, using repeated measurements of outcomes at baseline and 3, 6, and 9 months. Methods: This study is a secondary analysis using longitudinal data from the Run4Love trial, a randomized controlled trial with 300 people living with HIV and elevated depressive symptoms to examine the effects of a 3-month mHealth intervention on reducing depressive symptoms and improving quality of life (QOL). We examined the relationships between patient engagement and depressive symptoms, QOL, and perceived stress in the intervention group (N=150) using 4–time-point outcome measurements. Patient engagement was assessed using the completion rate of course assignments and frequency of items completed. Cluster analysis was used to categorize patients into high- and low-engagement groups. Generalized linear mixed effects models were conducted to investigate the dose–response relationships between patient engagement and outcomes. Results: The cluster analysis identified 2 clusters that were distinctively different from each other. The first cluster comprised 72 participants with good compliance to the intervention, completing an average of 74% (53/72) of intervention items (IQR 0.22). The second cluster comprised 78 participants with low compliance to the intervention, completing an average of 15% (11/72) of intervention items (IQR 0.23). Results of the generalized linear mixed effects models showed that, compared with the low-engagement group, the high-engagement group had a significant reduction in more depressive symptoms (β=−1.93; P=.008) and perceived stress (β=−1.72; P<.001) and an improved QOL (β=2.41; P=.01) over 9 months. From baseline to 3, 6, and 9 months, the differences in depressive symptoms between the 2 engagement groups were 0.8, 1.6, 2.3, and 3.7 points, respectively, indicating widening between-group differences over time. Similarly, between-group differences in QOL and perceived stress increased over time (group differences in QOL: 0.9, 1.9, 4.7, and 5.1 points, respectively; group differences in the Perceived Stress Scale: 0.9, 1.4, 2.3, and 3.0 points, respectively). Conclusions: This study revealed a positive long-term dose–response relationship between patient engagement and 3 psychosocial outcomes among people living with HIV and elevated depressive symptoms in an mHealth intervention over 9 months using 4 time-point repeat measurement data. The high- and low-engagement groups showed significant and widening differences in depressive symptoms, QOL, and perceived stress at the 3-, 6-, and 9-month follow-ups. Future mHealth interventions should improve patient engagement to achieve long-term and sustained intervention effects. Trial Registration: Chinese Clinical Trial Registry ChiCTR-IPR-17012606; https://www.chictr.org.cn/showproj.aspx?proj=21019 %M 34982724 %R 10.2196/25586 %U https://mhealth.jmir.org/2022/1/e25586 %U https://doi.org/10.2196/25586 %U http://www.ncbi.nlm.nih.gov/pubmed/34982724 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e27696 %T A Mobile Intervention to Link Young Female Entertainment Workers in Cambodia to Health and Gender-Based Violence Services: Randomized Controlled Trial %A Brody,Carinne %A Chhoun,Pheak %A Tuot,Sovannary %A Fehrenbacher,Anne E %A Moran,Alexander %A Swendeman,Dallas %A Yi,Siyan %+ Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, #10-01, Singapore, 117549, Singapore, 65 87533823, siyan@nus.edu.sg %K mHealth %K female sex workers %K HIV %K sexually transmitted infection %K linkage to services %K sexual and reproductive health %K gender-based violence %K low- and middle-income countries %D 2022 %7 4.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Female entertainment workers (FEWs) in Cambodia experience a greater prevalence of human immunodeficiency virus (HIV), other sexually transmitted infections (STIs), psychological distress, substance abuse, and gender-based violence (GBV) than the general female population. Reaching FEWs with health education and linking them to services has been difficult because of their hidden and stigmatized status. Objective: This study evaluated the efficacy of the Mobile Link intervention in improving FEWs’ health by engaging and connecting them to existing HIV, sexual and reproductive health, and GBV services. Methods: A randomized controlled trial was conducted between March 2018 and June 2019 in the capital city and 3 other provinces in Cambodia. FEWs in the intervention arm received automated twice-weekly Short Message Service messages and voice messages with health information and direct links to outreach workers. The control group received the existing standard care, including free HIV and STI counseling and testing and a toll-free helpline staffed by trained counselors. We used a stratified random sampling method to select participants from 5 study sites in the 4 selected provinces. Initially, we randomly selected 600 participants from a list of 4000 FEWs by age group (18-24 and 25-30 years) and study site using a random number generator and enrolled them in person. The primary outcome measures included self-reported HIV and STI testing, condom use, and contraceptive use assessed through a face-to-face structured interview. We also measured secondary outcomes, including contact with outreach workers, escorted referral service use, forced drinking, and GBV experiences. Intervention effects were modeled using repeated measures, multilevel mixed-effects logistic regression. Results: A total of 1118 participants were recruited and enrolled in the study. We included 218 FEWs in the intervention arm and 170 FEWs in the control arm in the per protocol analyses after removing 730 dropouts. Evidence of positive intervention effects was detected for the following secondary outcomes: contacting an outreach worker (at 30 weeks: adjusted odds ratio [AOR] 3.29, 95% CI 1.28-8.47), receiving an escorted referral (at 30 weeks: AOR 2.86, 95% CI 1.09-7.52; at 60 weeks: AOR 8.15, 95% CI 1.65-40.25), and never being forced to drink at work (at 60 weeks: AOR 3.95, 95% CI 1.62-9.60). Over time, no significant differences between intervention and control groups were observed for any primary outcomes in the fully adjusted models. Conclusions: The Mobile Link intervention effectively connected FEWs with outreach workers and escorted referrals but did not show an effect on primary outcomes. Reduced forced drinking at work was also significantly more extensive in the intervention group than in the control group. Longer-term messaging may increase access to services and impact FEWs’ health outcomes in the future. Trial Registration: Clinicaltrials.gov NCT03117842; https://clinicaltrials.gov/ct2/show/NCT03117842 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-018-2614-7 %M 34982716 %R 10.2196/27696 %U https://www.jmir.org/2022/1/e27696 %U https://doi.org/10.2196/27696 %U http://www.ncbi.nlm.nih.gov/pubmed/34982716 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 1 %P e30352 %T A Mobile App to Increase Fruit and Vegetable Acceptance Among Finnish and Polish Preschoolers: Randomized Trial %A Vepsäläinen,Henna %A Skaffari,Essi %A Wojtkowska,Katarzyna %A Barlińska,Julia %A Kinnunen,Satu %A Makkonen,Riikka %A Heikkilä,Maria %A Lehtovirta,Mikko %A Ray,Carola %A Suhonen,Eira %A Nevalainen,Jaakko %A Sajaniemi,Nina %A Erkkola,Maijaliisa %+ Department of Food and Nutrition, University of Helsinki, PO Box 66, Helsinki, 00014, Finland, 358 443581467, henna.vepsalainen@helsinki.fi %K gamification %K intervention %K behavior change %K health game %K games for health %K smartphone app %K mobile phone %D 2022 %7 4.1.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Early childhood education and care (ECEC) centers are ideal venues for food education. As smartphones and tablets are becoming increasingly popular in ECEC centers, technology can be used to deliver such pedagogical content. Evidence suggests that video games can affect fruit and vegetable (FV) consumption among 9- to 12-year-old children, but studies among preschoolers are scarce. Objective: This paper describes the development of the Mole’s Veggie Adventures app and its effectiveness in increasing FV acceptance among Finnish and Polish preschoolers aged 3 to 6 years. Methods: A multiprofessional team created an app to be used in ECEC centers in groups of 3 to 10 children. The app aimed to increase vegetable acceptance, and it was built using elements that support the development of self-regulation and social skills. Altogether, 7 Finnish and 4 Polish ECEC centers participated in the study. Before randomization, parents reported background factors and their children’s willingness to taste different FVs. The ECEC professionals in the intervention arm were instructed to use the app at least once a week during the 3- to 4-week intervention period. The main outcomes in this unblinded, cluster-randomized study were FV acceptance and relative FV acceptance. The first was calculated as a sum variable describing the children’s willingness to taste 25 different FVs, the second as FV acceptance divided by the number of FVs served. We used analysis of covariance to compare the FV acceptance and relative FV acceptance scores between the intervention and control groups at follow-up. Results: A total of 221 children were included in the analysis. At follow-up, the intervention group (115/221, 52%) had higher FV acceptance scores (baseline adjusted difference of mean 7.22; 95% CI 1.41-13.03) than the control group (106/221, 48%). The intervention effect was parallel for relative FV acceptance scores (baseline adjusted difference of mean 0.28; 95% CI 0.05-0.52). Conclusions: The Mole’s Veggie Adventures app has the potential to increase FV acceptance among preschoolers and can be a valuable tool in supporting food education in ECEC centers. Furthermore, the app can be feasibly incorporated into preschool routines in countries with different educational environments. Trial Registration: ClinicalTrials.gov NCT05173311; https://tinyurl.com/4vfbh283 %M 34982718 %R 10.2196/30352 %U https://mhealth.jmir.org/2022/1/e30352 %U https://doi.org/10.2196/30352 %U http://www.ncbi.nlm.nih.gov/pubmed/34982718 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 1 %P e30474 %T Using Health Concept Surveying to Elicit Usable Evidence: Case Studies of a Novel Evaluation Methodology %A Mariakakis,Alex %A Karkar,Ravi %A Patel,Shwetak N %A Kientz,Julie A %A Fogarty,James %A Munson,Sean A %+ Department of Computer Science, University of Toronto, Bahen Centre for Information Technology, Room 4283, 40 St. George Street, Toronto, ON, M5S 2E4, Canada, 1 416 978 5359, mariakakis@cs.toronto.edu %K mobile health %K survey instrument %K health screening %K health belief model %K path analysis %K user design %K health technology %K health intervention technology %K digital health %K mobile phone %D 2022 %7 3.1.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Developers, designers, and researchers use rapid prototyping methods to project the adoption and acceptability of their health intervention technology (HIT) before the technology becomes mature enough to be deployed. Although these methods are useful for gathering feedback that advances the development of HITs, they rarely provide usable evidence that can contribute to our broader understanding of HITs. Objective: In this research, we aim to develop and demonstrate a variation of vignette testing that supports developers and designers in evaluating early-stage HIT designs while generating usable evidence for the broader research community. Methods: We proposed a method called health concept surveying for untangling the causal relationships that people develop around conceptual HITs. In health concept surveying, investigators gather reactions to design concepts through a scenario-based survey instrument. As the investigator manipulates characteristics related to their HIT, the survey instrument also measures proximal cognitive factors according to a health behavior change model to project how HIT design decisions may affect the adoption and acceptability of an HIT. Responses to the survey instrument were analyzed using path analysis to untangle the causal effects of these factors on the outcome variables. Results: We demonstrated health concept surveying in 3 case studies of sensor-based health-screening apps. Our first study (N=54) showed that a wait time incentive could influence more people to go see a dermatologist after a positive test for skin cancer. Our second study (N=54), evaluating a similar application design, showed that although visual explanations of algorithmic decisions could increase participant trust in negative test results, the trust would not have been enough to affect people’s decision-making. Our third study (N=263) showed that people might prioritize test specificity or sensitivity depending on the nature of the medical condition. Conclusions: Beyond the findings from our 3 case studies, our research uses the framing of the Health Belief Model to elicit and understand the intrinsic and extrinsic factors that may affect the adoption and acceptability of an HIT without having to build a working prototype. We have made our survey instrument publicly available so that others can leverage it for their own investigations. %M 34982038 %R 10.2196/30474 %U https://humanfactors.jmir.org/2022/1/e30474 %U https://doi.org/10.2196/30474 %U http://www.ncbi.nlm.nih.gov/pubmed/34982038 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 12 %P e31367 %T Centering Lived Experience in Developing Digital Interventions for Suicide and Self-injurious Behaviors: User-Centered Design Approach %A Kruzan,Kaylee Payne %A Meyerhoff,Jonah %A Biernesser,Candice %A Goldstein,Tina %A Reddy,Madhu %A Mohr,David C %+ Center for Behavioral Intervention Technologies, Feinberg School of Medicine, Northwestern University, 750 N Lake Shore Dr, Chicago, IL, 60611, United States, 1 3125036585, kaylee.kruzan@northwestern.edu %K user-centered design %K intervention %K suicide %K nonsuicidal self-injury %K lived experience %K technology-enabled services %K digital intervention %K engagement %K mobile phone %D 2021 %7 24.12.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: The prevalence of self-injurious thoughts and behaviors (SITB) signals a growing public health crisis. Despite a recognized need for improved and scalable interventions, the field of SITB intervention faces several challenges: existing interventions are often time and resource intensive, most individuals with SITB do not seek formal mental health care, and efficacious treatments are characterized by small effects. Combined, these challenges indicate a need for improved SITB interventions for individuals in formal treatment and those who are not treatment engaged but are at high risk of worsening mental health and future suicide attempts. Objective: We present a methodological approach and set of techniques that may address these challenges by centering the lived experience of individuals with SITB in the process of developing needed services: user-centered design (UCD). Methods: We highlight the value of UCD in the context of digital interventions for SITB by describing the UCD approach and explicating how it can be leveraged to include lived experience throughout the development and evaluation process. We provide a detailed case example highlighting 3 phases of the early development process that can be used to design an intervention that is engaging and meets end-user needs. In addition, we point to novel applications of UCD to complement new directions in SITB research. Results: In this paper, we offer a 2-pronged approach to meet these challenges. First, in terms of addressing access to effective interventions, digital interventions hold promise to extend the reach of evidence-based treatments outside of brick-and-mortar health care settings. Second, to address challenges related to treatment targets and engagement, we propose involving individuals with lived experience in the design and research process. Conclusions: UCD offers a well-developed and systematic process to center the unique needs, preferences, and perceived barriers of individuals with lived SITB experience in the development and evaluation of digital interventions. %M 34951602 %R 10.2196/31367 %U https://mental.jmir.org/2021/12/e31367 %U https://doi.org/10.2196/31367 %U http://www.ncbi.nlm.nih.gov/pubmed/34951602 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 12 %P e32932 %T A Smartphone-Based Self-management Intervention for Individuals With Bipolar Disorder (LiveWell): Protocol Development for an Expert System to Provide Adaptive User Feedback %A Goulding,Evan H %A Dopke,Cynthia A %A Michaels,Tania %A Martin,Clair R %A Khiani,Monika A %A Garborg,Christopher %A Karr,Chris %A Begale,Mark %+ Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, Suite 7-102, 303 East Chicago Ave, Chicago, IL, 60611, United States, 1 312 503 1189, e-goulding@fsm.northwestern.edu %K adaptive %K personalized %K self-management %K smartphone %K behavioral intervention technology %K mHealth %K bipolar disorder %K depression %K mania %D 2021 %7 24.12.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Bipolar disorder is a severe mental illness that results in significant morbidity and mortality. While pharmacotherapy is the primary treatment, adjunctive psychotherapy can improve outcomes. However, access to therapy is limited. Smartphones and other technologies can increase access to therapeutic strategies that enhance self-management while simultaneously augmenting care by providing adaptive delivery of content to users as well as alerts to providers to facilitate clinical care communication. Unfortunately, while adaptive interventions are being developed and tested to improve care, information describing the components of adaptive interventions is often not published in sufficient detail to facilitate replication and improvement of these interventions. Objective: To contribute to and support the improvement and dissemination of technology-based mental health interventions, we provide a detailed description of the expert system for adaptively delivering content and facilitating clinical care communication for LiveWell, a smartphone-based self-management intervention for individuals with bipolar disorder. Methods: Information from empirically supported psychotherapies for bipolar disorder, health psychology behavior change theories, and chronic disease self-management models was combined with user-centered design data and psychiatrist feedback to guide the development of the expert system. Results: Decision points determining the timing of intervention option adaptation were selected to occur daily and weekly based on self-report data for medication adherence, sleep duration, routine, and wellness levels. These data were selected for use as the tailoring variables determining which intervention options to deliver when and to whom. Decision rules linking delivery of options and tailoring variable thresholds were developed based on existing literature regarding bipolar disorder clinical status and psychiatrist feedback. To address the need for treatment adaptation with varying clinical statuses, decision rules for a clinical status state machine were developed using self-reported wellness rating data. Clinical status from this state machine was incorporated into hierarchal decision tables that select content for delivery to users and alerts to providers. The majority of the adaptive content addresses sleep duration, medication adherence, managing signs and symptoms, building and utilizing support, and keeping a regular routine, as well as determinants underlying engagement in these target behaviors as follows: attitudes and perceptions, knowledge, support, evaluation, and planning. However, when problems with early warning signs, symptoms, and transitions to more acute clinical states are detected, the decision rules shift the adaptive content to focus on managing signs and symptoms, and engaging with psychiatric providers. Conclusions: Adaptive mental health technologies have the potential to enhance the self-management of mental health disorders. The need for individuals with bipolar disorder to engage in the management of multiple target behaviors and to address changes in clinical status highlights the importance of detailed reporting of adaptive intervention components to allow replication and improvement of adaptive mental health technologies for complex mental health problems. %M 34951598 %R 10.2196/32932 %U https://formative.jmir.org/2021/12/e32932 %U https://doi.org/10.2196/32932 %U http://www.ncbi.nlm.nih.gov/pubmed/34951598 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e33877 %T Condomless Anal Sex Associated With Heterogeneous Profiles Of HIV Pre-Exposure Prophylaxis Use and Sexual Activities Among Men Who Have Sex With Men: A Latent Class Analysis Using Sex Diary Data on a Mobile App %A Yu,Yi-Fang %A Wu,Huei-Jiuan %A Ku,Stephane Wen-Wei %A Huang,Po-Hsien %A Li,Chia-Wen %A Huang,Poyao %A Strong,Carol %+ Department of Public Health, College of Medicine, National Cheng Kung University, 1 University Road, Tainan, 70101, Taiwan, 886 662353535, carol.chiajung@gmail.com %K mobile apps %K pre-exposure prophylaxis %K PrEP %K latent class analysis %K men who have sex with men %K MSM %K condom %K sex diaries %K adherence %K app %K sex %K diary %K sexual health %K HIV %K Taiwan %K risk %K prevention %D 2021 %7 23.12.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: New innovative technologies, such as mobile apps, have been developed to increase pre-exposure prophylaxis (PrEP) adherence and the use of log sex diaries. The contiguity of mobile apps reduces the recall bias that generally affects reported condom and PrEP use. However, none of the currently used mobile apps were designed for event-driven PrEP users, and few studies have demonstrated the potential usage of sex diary data to facilitate the understanding of the different HIV risks among heterogeneous profiles of sex diaries and PrEP use. Objective: We aim to discriminate the heterogeneous profiles of sex events and PrEP use and examine the risk of condomless anal sex among different types of sex events. Methods: We recruited 35 adult men who have sex with men from two medical centers in Taiwan since May 2020 and followed up for four months. Participants were on PrEP or willing to take PrEP. They were asked to log their sex events, PrEP use, and dosing regimens on a mobile app to improve their PrEP adherence. Latent class analysis was used to distinguish profiles of sex events and PrEP use. Indicators included correct intake of PrEP for each sex event, participants’ sexual positioning, partner’s HIV status, and age. Results: A total of 551 sex events were classified into three classes by latent class analysis: PrEP nonadherent flip-flopping (234/551, 42%), PrEP imperfect-adherent power bottoming (284/551, 52%), and PrEP adherent serodiscordant topping (33/551, 6%). “PrEP nonadherent flip-flopping” sex events were more likely to involve condomless anal sex than “PrEP imperfect-adherent power bottoming” (OR 1.83, 95% CI 1.03-3.25) after considering random intercepts for individuals, and this class needed to increase their PrEP adherence and use of condoms. “PrEP imperfect-adherent power bottoming” realized their own risk and packaged PrEP with condoms to protect themselves. Up to 99% (32/33) of sex events in “PrEP adherent serodiscordant topping” were protected by PrEP, but all of the sex events in this group were condomless. Conclusions: Using the sex diary data could advance the capacity to identify high-risk groups. HIV prevention strategy should be more flexible and combine PrEP with condom use for future HIV prevention. %M 34941560 %R 10.2196/33877 %U https://www.jmir.org/2021/12/e33877 %U https://doi.org/10.2196/33877 %U http://www.ncbi.nlm.nih.gov/pubmed/34941560 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 12 %P e34534 %T Getting “Back on Track” After a Cardiac Event: Protocol for a Randomized Controlled Trial of a Web-Based Self-management Program %A Rogerson,Michelle C %A Jackson,Alun C %A Navaratnam,Hema S %A Le Grande,Michael R %A Higgins,Rosemary O %A Clarke,Joanne %A Murphy,Barbara M %+ Australian Centre for Heart Health, 75-79 Chetwynd St, North Melbourne, 3051, Australia, 61 3 9326 8544, michelle.rogerson@australianhearthealth.org.au %K coronary heart disease %K heart disease %K coronary %K cardiovascular %K prevention %K RCT %K randomized control trial %K secondary prevention %K self-management %K online %K randomised controlled trial %K health behaviours %K health behaviour %K health behavior %K depression %K cognitive behaviour therapy %K motivational interviewing %D 2021 %7 23.12.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: After a cardiac event, a large majority of patients with cardiac conditions do not achieve recommended behavior change targets for secondary prevention. Mental health issues can also impact the ability to engage in health behavior change. There is a need for innovative, flexible, and theory-driven eHealth programs, which include evidence-based strategies to assist patients with cardiac conditions with their recovery, especially in behavioral and emotional self-management. Objective: The aim of this study is to determine the short- and longer-term behavioral and emotional well-being outcomes of the Back on Track web-based self-management program. In addition, this study will test whether there is enhanced benefit of providing one-on-one telephone support from a trained lifestyle counselor, over and above benefit obtained through completing the web-based program alone. Methods: People who have experienced a cardiac event in the previous 12 months and have access to the internet will be eligible for this study (N=120). Participants will be randomly assigned to one of the two study conditions: either “self-directed” completion of the Back on Track program (without assistance) or “supported” completion of the Back on Track program (additional 2 telephone sessions with a lifestyle counselor). All participants will have access to the web-based Back on Track program for 2 months. Telephone sessions with the supported arm participants will occur at approximately 2 and 6 weeks post enrollment. Measures will be assessed at baseline, and then 2 and 6 months later. Outcome measures assessed at all 3 timepoints include dietary intake, physical activity and sitting time, smoking status, anxiety and depression, stage of change, and self-efficacy in relation to behavioral and emotional self-management, quality of life, and self-rated health and well-being. A demographic questionnaire will be included at baseline only and program acceptability at 2 months only. Results: Recruitment began in May 2020 and concluded in August 2021. Data collection for the 6-month follow-up will be completed by February 2022, and data analysis and publication of results will be completed by June 2022. A total of 122 participants were enrolled in this study. Conclusions: The Back on Track trial will enable us to quantify the behavioral and emotional improvements obtained and maintained for patients with cardiac conditions and, in particular, to compare two modes of delivery: (1) fully self-directed delivery and (2) supported by a lifestyle counselor. We anticipate that the web-based Back on Track program will assist patients in their recovery and self-management after an acute event, and represents an effective, flexible, and easily accessible adjunct to center-based rehabilitation programs. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620000102976; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378920&isReview=true International Registered Report Identifier (IRRID): DERR1-10.2196/34534 %M 34941550 %R 10.2196/34534 %U https://www.researchprotocols.org/2021/12/e34534 %U https://doi.org/10.2196/34534 %U http://www.ncbi.nlm.nih.gov/pubmed/34941550 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e22107 %T Effectiveness and Moderators of an Internet-Based Mobile-Supported Stress Management Intervention as a Universal Prevention Approach: Randomized Controlled Trial %A Ebert,David Daniel %A Franke,Marvin %A Zarski,Anna-Carlotta %A Berking,Matthias %A Riper,Heleen %A Cuijpers,Pim %A Funk,Burkhardt %A Lehr,Dirk %+ Department of Sport and Health Sciences, Technical University of Munich, Georg-Brauchle-Ring 60/62, TUM Campus D, Munich, 80992, Germany, 49 15116781057, david.daniel.ebert@tum.de %K stress management intervention %K universal prevention %K occupational health %K moderators %D 2021 %7 22.12.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Emerging evidence indicates the effectiveness of internet-based mobile-supported stress management interventions (iSMIs) in highly stressed employees. It is yet unclear, however, whether iSMIs are also effective without a preselection process in a universal prevention approach, which more closely resembles routine occupational health care. Moreover, evidence for whom iSMIs might be suitable and for whom not is scarce. Objective: The aim of this study was to evaluate the iSMI GET.ON Stress in a universal prevention approach without baseline inclusion criteria and to examine the moderators of the intervention effects. Methods: A total of 396 employees were randomly assigned to the intervention group or the 6-month waiting list control group. The iSMI consisted of 7 sessions and 1 booster session and offered no therapeutic guidance. Self-report data were assessed at baseline, 7 weeks, and at 6 months following randomization. The primary outcome was perceived stress. Several a priori defined moderators were explored as potential effect modifiers. Results: Participants in the intervention group reported significantly lower perceived stress at posttreatment (d=0.71, 95% CI 0.51-0.91) and at 6-month follow-up (d=0.61, 95% CI 0.41-0.81) compared to those in the waiting list control group. Significant differences with medium-to-large effect sizes were found for all mental health and most work-related outcomes. Resilience (at 7 weeks, P=.04; at 6 months, P=.01), agreeableness (at 7 weeks, P=.01), psychological strain (at 6 months, P=.04), and self-regulation (at 6 months, P=.04) moderated the intervention effects. Conclusions: This study indicates that iSMIs can be effective in a broad range of employees with no need for preselection to achieve substantial effects. The subgroups that might not profit had extreme values on the respective measures and represented only a very small proportion of the investigated sample, thereby indicating the broad applicability of GET.ON Stress. Trial Registration: German Clinical Trials Register DRKS00005699; https://www.drks.de/DRKS00005699 %M 34941541 %R 10.2196/22107 %U https://www.jmir.org/2021/12/e22107 %U https://doi.org/10.2196/22107 %U http://www.ncbi.nlm.nih.gov/pubmed/34941541 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e23513 %T The Long-Term Effectiveness of Internet-Based Interventions on Multiple Health Risk Behaviors: Systematic Review and Robust Variance Estimation Meta-analysis %A Tzelepis,Flora %A Mitchell,Aimee %A Wilson,Louise %A Byrnes,Emma %A Haschek,Alexandra %A Leigh,Lucy %A Oldmeadow,Christopher %+ School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, 2308, Australia, 61 2 49246275, flora.tzelepis@newcastle.edu.au %K internet %K multiple health behaviors %K tobacco %K nutrition %K alcohol %K physical activity %D 2021 %7 21.12.2021 %9 Review %J J Med Internet Res %G English %X Background: Smoking tobacco, poor nutrition, risky alcohol use, and physical inactivity (SNAP) behaviors tend to cluster together. Health benefits may be maximized if interventions targeted multiple health risk behaviors together rather than addressing single behaviors. The internet has wide reach and is a sustainable mode for delivery of interventions for multiple health behaviors. However, no systematic reviews have examined the long-term effectiveness of internet-based interventions on any combination of or all SNAP behaviors in adults aged 18 years or older. Objective: This systematic review examined, among adults (aged ≥18 years), the effectiveness of internet-based interventions on SNAP behaviors collectively in the long term compared with a control condition. Methods: The electronic databases Medline, PsycINFO, Embase, CINAHL, and Scopus were searched to retrieve studies describing the effectiveness of internet-based interventions on ≥2 SNAP behaviors published by November 18, 2019. The reference lists of retrieved articles were also checked to identify eligible publications. The inclusion criteria were randomized controlled trials or cluster randomized controlled trials with adults examining an internet-based intervention measuring the effect on ≥2 SNAP behaviors at least 6 months postrecruitment and published in English in a peer-reviewed journal. Two reviewers independently extracted data from included studies and assessed methodological quality using the Quality Assessment Tool for Quantitative Studies. A robust variance estimation meta-analysis was performed to examine the long-term effectiveness of internet-based interventions on all 4 SNAP risk behavior outcomes. All SNAP outcomes were coded so they were in the same direction, with higher scores equating to worse health risk behaviors. Results: The inclusion criteria were met by 11 studies: 7 studies measured the effect of an internet-based intervention on nutrition and physical activity; 1 study measured the effect on smoking, nutrition, and physical activity; and 3 studies measured the effect on all SNAP behaviors. Compared with the control group, internet-based interventions achieved an overall significant improvement across all SNAP behaviors in the long term (standardized mean difference –0.12 [improvement as higher scores = worse health risk outcomes], 95% CI –0.19 to –0.05; I2=1.5%, P=.01). The global methodological quality rating was “moderate” for 1 study, while the remaining 10 studies were rated as “weak.” Conclusions: Internet-based interventions were found to produce an overall significant improvement across all SNAP behaviors collectively in the long term. Internet-based interventions targeting multiple SNAP behaviors have the potential to maximize long-term improvements to preventive health outcomes. %M 34931990 %R 10.2196/23513 %U https://www.jmir.org/2021/12/e23513 %U https://doi.org/10.2196/23513 %U http://www.ncbi.nlm.nih.gov/pubmed/34931990 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e24114 %T Design and Development of a Suite of Intimate Partner Violence Screening and Safety Planning Web Apps: User-Centered Approach %A O'Campo,Patricia %A Velonis,Alisa %A Buhariwala,Pearl %A Kamalanathan,Janisha %A Hassan,Maha Awaiz %A Metheny,Nicholas %+ MAP Center for Urban Health Solutions, St. Michael's Hospital, 30 Bond St, Toronto, ON, M5W 1W8, Canada, 1 4766304000, patricia.ocampo@unityhealth.to %K intimate partner violence %K web-based applications %K women %K user-centered design %D 2021 %7 21.12.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The popularity of mobile health (mHealth) technology has resulted in the development of numerous apps for almost every condition and disease management. mHealth and eHealth solutions for increasing awareness about, and safety around, intimate partner violence are no exception. These apps allow women to control access to these resources and provide unlimited, and with the right design features, safe access when these resources are needed. Few apps, however, have been designed in close collaboration with intended users to ensure relevance and effectiveness. Objective: The objective of this paper is to discuss the design of a suite of evidence-based mHealth and eHealth apps to facilitate early identification of unsafe relationship behaviors and tailored safety planning to reduce harm from violence including the methods by which we collaborated with and sought input from a population of intended users. Methods: A user-centered approach with aspects of human-centered design was followed to design a suite of 3 app-based safety planning interventions. Results: This review of the design suite of app-based interventions revealed challenges faced and lessons learned that may inform future efforts to design evidence-based mHealth and eHealth interventions. Conclusions: Following a user-centered approach can be helpful in designing mHealth and eHealth interventions for marginalized and vulnerable populations, and led to novel insights that improved the design of our interventions. %M 34931998 %R 10.2196/24114 %U https://www.jmir.org/2021/12/e24114 %U https://doi.org/10.2196/24114 %U http://www.ncbi.nlm.nih.gov/pubmed/34931998 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 12 %P e30000 %T Understanding Engagement Strategies in Digital Interventions for Mental Health Promotion: Scoping Review %A Saleem,Maham %A Kühne,Lisa %A De Santis,Karina Karolina %A Christianson,Lara %A Brand,Tilman %A Busse,Heide %+ Department of Prevention and Evaluation, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Achterstraße 30, Bremen, 28359, Germany, 49 42121856 ext 923, saleem@leibniz-bips.de %K digital interventions %K mental health promotion %K engagement %K scoping review %K mobile phone %D 2021 %7 20.12.2021 %9 Review %J JMIR Ment Health %G English %X Background: Digital interventions offer a solution to address the high demand for mental health promotion, especially when facing physical contact restrictions or lacking accessibility. Engagement with digital interventions is critical for their effectiveness; however, retaining users’ engagement throughout the intervention is challenging. It remains unclear what strategies facilitate engagement with digital interventions that target mental health promotion. Objective: Our aim is to conduct a scoping review to investigate user engagement strategies and methods to evaluate engagement with digital interventions that target mental health promotion in adults. Methods: This scoping review adheres to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for scoping reviews. The search was conducted in 7 electronic databases from inception to April 2020. The inclusion criteria for studies were as follows: adult (aged ≥18 years) users of digital interventions for mental health promotion from the general population; any digital intervention for mental health promotion; and user engagement strategies described in the intervention design. We extracted the following data items: study characteristics, digital intervention (type and engagement strategy), evaluation of engagement strategy (method and result specifying whether the strategy was effective at facilitating engagement), and features of engagement (extent of use and subjective experience of users). Results: A total of 2766 studies were identified, of which 16 (0.58%) met the inclusion criteria. The 16 studies included randomized controlled trials (6/16, 37%), studies analyzing process data (5/16, 31%), observational studies (3/16, 19%), and qualitative studies (2/16, 13%). The digital interventions for mental health promotion were either web based (12/16, 75%) or mobile app based (4/16, 25%). The engagement strategies included personalized feedback about intervention content or users’ mental health status; guidance regarding content and progress through e-coaching; social forums, and interactivity with peers; content gamification; reminders; and flexibility and ease of use. These engagement strategies were deemed effective based on qualitative user feedback or responses on questionnaires or tools (4/16, 25%), usability data (5/16, 31%), or both (7/16, 44%). Most studies identified personalized support in the form of e-coaching, peer support through a social platform, personalized feedback, or joint videoconference sessions as an engaging feature. Conclusions: Personalized support during the intervention, access to social support, and personalized feedback seem to promote engagement with digital interventions for mental health promotion. These findings need to be interpreted with caution because the included studies were heterogeneous, had small sample sizes, and typically did not address engagement as the primary outcome. Despite the importance of user engagement for the effectiveness of digital interventions, this field has not yet received much attention. Further research is needed on the effectiveness of different strategies required to facilitate user engagement in digital interventions for mental health promotion. %M 34931995 %R 10.2196/30000 %U https://mental.jmir.org/2021/12/e30000 %U https://doi.org/10.2196/30000 %U http://www.ncbi.nlm.nih.gov/pubmed/34931995 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 4 %N 4 %P e29731 %T Toward a Behavior Theory–Informed and User-Centered Mobile App for Parents to Prevent Infant Falls: Development and Usability Study %A Cooray,Nipuna %A Sun,Si Louise %A Ho,Catherine %A Adams,Susan %A Keay,Lisa %A Nassar,Natasha %A Brown,Julie %+ The George Institute for Global Health, Faculty of Medicine and Health, UNSW Sydney, Level 5/1, King Street, Newtown, 2042, Australia, 61 468311723, ncooray@georgeinstitute.org.au %K child injury %K Behaviour Change Wheel %K mobile app %K mobile phone %D 2021 %7 20.12.2021 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Falls account for approximately 50% of infant injury hospitalizations, and caretaker behavior is central to preventing infant falls. Behavior theory–informed interventions for injury prevention have been suggested, but to date, few have been reported. The potential of using smartphones for injury prevention intervention delivery is also underexploited. Objective: This study aims to develop a behavior theory– and evidence-based as well as user-centered digital intervention as a mobile app for parents to prevent infant falls following agile development practices. Methods: Infant falls while feeding was selected as the fall mechanism to demonstrate the approach being taken to develop this intervention. In phase 1, the Behaviour Change Wheel was used as a theoretical framework supported by a literature review to define intervention components that were then implemented as a mobile app. In phase 2, after the person-based approach, user testing through think-aloud interviews and comprehension assessments were used to refine the content and implementation of the intervention. Results: The target behaviors identified in phase 1 were adequate rest for the newborn’s mother and safe feeding practices defined as prepare, position, and place. From behavioral determinants and the Behaviour Change Wheel, the behavior change functions selected to achieve these target behaviors were psychological capability, social opportunity, and reflective motivation. The selected behavior change techniques aligned with these functions were providing information on health consequences, using a credible source, instruction on performing each behavior, and social support. The defined intervention was implemented in a draft Android app. In phase 2, 4 rounds of user testing were required to achieve the predefined target comprehension level. The results from the think-aloud interviews were used to refine the intervention content and app features. Overall, the results from phase 2 revealed that users found the information provided to be helpful. Features such as self-tracking and inclusion of the social and environmental aspects of falls prevention were liked by the participants. Important feedback for the successful implementation of the digital intervention was also obtained from the user testing. Conclusions: To our knowledge, this is the first study to apply the Behaviour Change Wheel to develop a digital intervention for child injury prevention. This study provides a detailed example of evidence-based development of a behavior theory–informed mobile intervention for injury prevention refined using the person-based approach. %M 34932004 %R 10.2196/29731 %U https://pediatrics.jmir.org/2021/4/e29731 %U https://doi.org/10.2196/29731 %U http://www.ncbi.nlm.nih.gov/pubmed/34932004 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 4 %N 4 %P e17723 %T Recruitment and Retention of Parents of Adolescents in a Text Messaging Trial (MyTeen): Secondary Analysis From a Randomized Controlled Trial %A Chu,Joanna Ting Wai %A Wadham,Angela %A Jiang,Yannan %A Stasiak,Karolina %A Shepherd,Matthew %A Bullen,Christopher %+ The National Institute for Health Innovation, School of Population Health, University of Auckland, Private Bag 92019 Victoria Street West, Auckland, 1142, New Zealand, 64 3737599, jt.chu@auckland.ac.nz %K parenting %K mHealth %K text messaging %K recruitment %D 2021 %7 20.12.2021 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Parenting programs are well established as an effective strategy for enhancing both parenting skills and the well-being of the child. However, recruitment for family programs in clinical and nonclinical settings remains low. Objective: This study aims to describe the recruitment and retention methods used in a text messaging program (MyTeen) trial for parents of adolescents (10-15 years) and identify key lessons learned. We aim to provide insights and direction for researchers who seek to recruit parents and build on the limited literature on recruitment and retention strategies for parenting program trials. Methods: A recruitment plan was developed, monitored, and modified as needed throughout the course of the project. Strategies to facilitate recruitment were identified (eg, program content and recruitment material, staff characteristics, and study procedures). Traditional and web-based recruitment strategies were used. Results: Over a 5-month period, 319 parents or caregivers expressed interest in our study, of which 221 agreed to participate in the study, exceeding our recruitment target of 214 participants. Attrition was low at the 1-month (4.5% overall; intervention group: n=5, 4.6%; control group: n=5, 4.5%) and 3-month follow-ups (9% overall; intervention group: n=10, 9.2%; control group: n=10, 8.9%). Conclusions: The use of web-based recruitment strategies appeared to be most effective for recruiting and retaining parents in a text-messaging program trial. However, we encountered recruitment challenges (ie, underrepresentation of ethnic minority groups and fathers) similar to those reported in the literature. Therefore, efforts to engage ethnic minorities and fathers are needed. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618000117213; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374307 %M 34932007 %R 10.2196/17723 %U https://pediatrics.jmir.org/2021/4/e17723 %U https://doi.org/10.2196/17723 %U http://www.ncbi.nlm.nih.gov/pubmed/34932007 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 12 %P e28128 %T A Wearable Activity Tracker Intervention With and Without Weekly Behavioral Support Emails to Promote Physical Activity Among Women Who Are Overweight or Obese: Randomized Controlled Trial %A Black,Melissa %A Brunet,Jennifer %+ School of Human Kinetics, Faculty of Health Sciences, University of Ottawa, 125 University Private, Ottawa, ON, K1N6N5, Canada, 1 6135625800 ext 3068, jennifer.brunet@uottawa.ca %K behavior change %K motivation %K obesity %K physical activity %K women %K mobile phone %D 2021 %7 16.12.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Physical activity (PA) plays a fundamental role in combating the current obesity epidemic; however, most women who are overweight or obese are generally physically inactive. Wearable activity tracker interventions can help increase the PA levels in this population. Supplementing such interventions with behavioral support emails may further improve their effectiveness, but this remains to be confirmed. Objective: This study aims to determine if adding behavioral support emails to a wearable activity tracker intervention can further increase PA levels among women who are overweight or obese in comparison to a wearable activity tracker–only intervention and a control condition. Methods: Women with a BMI ≥25 kg/m2 who were not meeting the Canadian PA guidelines for aerobic and strength training were randomized into 1 of 3 groups. Group 1 received 6 weekly behavioral support emails, a wearable activity tracker, and a copy of the Canadian PA guidelines. Group 2 received a wearable activity tracker and a copy of the Canadian PA guidelines, and group 3 (control condition) received a copy of the Canadian PA guidelines. Self-reported data for walking and moderate to vigorous intensity PA were collected preintervention (week 0; prerandomization), postintervention (7 weeks postrandomization), and at follow-up (21 weeks postrandomization) and analyzed as metabolic equivalent of task minutes per week. In addition, potential mechanisms of behavior change (ie, basic psychological needs satisfaction and motivational regulations) were assessed for within- and between-group differences at all 3 time points. Data were analyzed using nonparametric statistical tests. Results: A total of 49 women were recruited; data from 47 women (mean age 37.57 years, SD 11.78 years; mean BMI 31.69 kg/m2, SD 5.97 kg/m2) were available for analysis. Group 1 reported a significant increase in walking from preintervention to postintervention (χ22=7.5; P=.02) but not in moderate to vigorous intensity PA (P=.24). Group 1 also reported significant increases in perceptions of competence from preintervention to follow-up (χ22=7.6; P=.02) and relatedness from preintervention to follow-up (χ22=8.7; P=.005). Increases in perceived autonomy were observed for group 2 (χ22=7.0) and group 3 (χ22=10.6). There were no significant changes in the motivational regulations within the groups. The difference between the groups was not significant for any outcome variable. Conclusions: The results suggest that adding behavioral support emails to a wearable activity tracker intervention may help to increase time spent walking and perceptions of competence and relatedness for PA among women who are overweight or obese. Trial Registration: ClinicalTrials.gov NCT03601663; http://clinicaltrials.gov/ct2/show/NCT03601663 %M 34927590 %R 10.2196/28128 %U https://mhealth.jmir.org/2021/12/e28128 %U https://doi.org/10.2196/28128 %U http://www.ncbi.nlm.nih.gov/pubmed/34927590 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 12 %P e26814 %T An Adjunctive Internet-Based Intervention to Enhance Treatment for Depression in Adults: Randomized Controlled Trial %A Pérez,J Carola %A Fernández,Olga %A Cáceres,Cristián %A Carrasco,Álvaro E %A Moessner,Markus %A Bauer,Stephanie %A Espinosa-Duque,Daniel %A Gloger,Sergio %A Krause,Mariane %+ Facultad de Psicología, Universidad del Desarrollo, Avda La Plaza 680, Las Condes, Santiago, 7610658, Chile, 56 997 051 989, janetperez@udd.cl %K depression %K e-mental health %K blended care %K internet %D 2021 %7 16.12.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: Internet-based interventions promise to enhance the accessibility of mental health care for a greater number of people and in more remote places. Their effectiveness has been shown for the prevention and treatment of various mental disorders. However, their potential when delivered as add-on to conventional treatment (ie, blended care) is less clear. Objective: The aim of this study is to study the effectiveness of an internet intervention (ASCENSO) implemented in addition to face-to-face treatment as usual (TAU) for depression. Methods: A 2-arm, parallel-group, randomized controlled trial was conducted in an outpatient private mental health care center in Chile. In all, 167 adults, diagnosed with major depressive disorder, without severe comorbidities, and with internet access, were included. Eighty-four participants were assigned to the intervention group and received medical and psychological TAU from the mental health center plus access to the ASCENSO online platform. The control group (n=83) received only TAU. The ASCENSO platform includes psycho-educational information, depressive symptom monitoring and feedback, and managing emergencies based on the principles of cognitive behavioral therapy. Emergency management was mental health provider–assisted. TAU includes access to primary care physicians and psychiatrists, to a brief individual psychotherapy, and to medication when needed. The baseline questionnaires were administered in person, and 6- and 9-months assessments were conducted online. Depression symptoms and quality of life were measured by self-administered questionnaires, and treatment adherence was determined via the Mental Health Center’s internal records. The usage of ASCENSO was assessed by server logs. Reduction on depressive symptomatology was considered as the primary outcome of the intervention and quality of life as a secondary outcome. Results: Of the 84 participants in the intervention group, 5 participants (6%) never accessed the online platform. Of the remaining 79 participants who accessed ASCENSO, 1 (1%, 1/79) did not answer any of the symptom questionnaire, and most participants (72/79, 91%) answered the monitoring questionnaires irregularly. The ASCENSO intervention implemented in addition to face-to-face care did not improve the outcome of the usual care delivered at the mental health center, either in terms of reduction of depressive symptoms (F2,6087= 0.48; P=.62) or in the improvement of quality of life (EQ-5D-3L: F2,7678=0.24; P=.79 and EQ-VAS: F2,6670= 0.13; P=.88). In contrast, for the primary (F2,850=78.25; P<.001) and secondary outcomes (EQ-5D-3L: F2,1067=37.87; EQ-VAS: F2,4390= 51.69; P<.001) in both groups, there was an improvement from baseline to 6 months (P<.001), but there was no change at 9 months. In addition, no effects on adherence to or use of TAU were found. Finally, the dropout rate for the face-to-face treatment component was 54% (45/84) for the intervention group versus 39% (32/83) for the control group (P=.07). Conclusions: The fact that the adjunctive access to ASCENSO did not improve outcome could be due to both the rather high effectiveness of TAU and to patients’ limited use of the online platform. Trial Registration: ClinicalTrials.gov NCT03093467; https://clinicaltrials.gov/ct2/show/NCT03093467 %M 34927594 %R 10.2196/26814 %U https://mental.jmir.org/2021/12/e26814 %U https://doi.org/10.2196/26814 %U http://www.ncbi.nlm.nih.gov/pubmed/34927594 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e22672 %T A Digital Platform to Support Self-management of Multiple Chronic Conditions (ProACT): Findings in Relation to Engagement During a One-Year Proof-of-Concept Trial %A Doyle,Julie %A Murphy,Emma %A Gavin,Shane %A Pascale,Alessandra %A Deparis,Stéphane %A Tommasi,Pierpaolo %A Smith,Suzanne %A Hannigan,Caoimhe %A Sillevis Smitt,Myriam %A van Leeuwen,Cora %A Lastra,Julia %A Galvin,Mary %A McAleer,Patricia %A Tompkins,Lorraine %A Jacobs,An %A M Marques,Marta %A Medina Maestro,Jaime %A Boyle,Gordon %A Dinsmore,John %+ NetwellCASALA, Dundalk Institute of Technology, Dublin Road, Dundalk, A91 K584, Ireland, 353 429370497, julie.doyle@dkit.ie %K digital health %K aging %K multimorbidity %K chronic disease %K self-management %K integrated care %K longitudinal study %K engagement %K usability %K mobile phone %D 2021 %7 15.12.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Populations globally are ageing, resulting in higher incidence rates of chronic diseases. Digital health platforms, designed to support those with chronic conditions to self-manage at home, offer a promising solution to help people monitor their conditions and lifestyle, maintain good health, and reduce unscheduled clinical visits. However, despite high prevalence rates of multimorbidity or multiple chronic conditions, most platforms tend to focus on a single disease. A further challenge is that despite the importance of users actively engaging with such systems, little research has explored engagement. Objective: The objectives of this study are to design and develop a digital health platform, ProACT, for facilitating older adults self-managing multimorbidity, with support from their care network, and evaluate end user engagement and experiences with this platform through a 12-month trial. Methods: The ProACT digital health platform is presented in this paper. The platform was evaluated in a year-long proof-of-concept action research trial with 120 older persons with multimorbidity in Ireland and Belgium. Alongside the technology, participants had access to a clinical triage service responding to symptom alerts and a technical helpdesk. Interactions with the platform during the trial were logged to determine engagement. Semistructured interviews were conducted with participants and analyzed using inductive thematic analysis, whereas usability and user burden were examined using validated questionnaires. Results: This paper presents the ProACT platform and its components, along with findings on engagement with the platform and its usability. Of the 120 participants who participated, 24 (20%) withdrew before the end of the study, whereas 3 (2.5%) died. The remaining 93 participants actively used the platform until the end of the trial, on average, taking 2 or 3 health readings daily over the course of the trial in Ireland and Belgium, respectively. The participants reported ProACT to be usable and of low burden. Findings from interviews revealed that participants experienced multiple benefits as a result of using ProACT, including improved self-management, health, and well-being and support from the triage service. For those who withdrew, barriers to engagement were poor health and frustration when technology, in particular sensing devices, did not work as expected. Conclusions: This is the first study to present findings from a longitudinal study of older adults using digital health technology to self-manage multimorbidity. Our findings show that older adults sustained engagement with the technology and found it usable. Potential reasons for these results include a strong focus on user-centered design and engagement throughout the project lifecycle, resulting in a platform that meets user needs, as well as the integration of behavior change techniques and personal analytics into the platform. The provision of triage and technical support services alongside the platform during the trial were also important facilitators of engagement. International Registered Report Identifier (IRRID): RR2-10.2196/22125 %M 34914612 %R 10.2196/22672 %U https://www.jmir.org/2021/12/e22672 %U https://doi.org/10.2196/22672 %U http://www.ncbi.nlm.nih.gov/pubmed/34914612 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e25902 %T Feasibility of a Web-Based Implementation Intervention to Improve Child Dietary Intake in Early Childhood Education and Care: Pilot Randomized Controlled Trial %A Barnes,Courtney %A Yoong,Sze Lin %A Nathan,Nicole %A Wolfenden,Luke %A Wedesweiler,Taya %A Kerr,Jayde %A Ward,Dianne S %A Grady,Alice %+ Hunter New England Population Health, Locked Bag 10, Wallsend, Newcastle, 2287, Australia, 61 0249246678, courtney.barnes@health.nsw.gov.au %K childcare center %K web-based %K nutrition %K healthy eating %K randomized controlled trial %K intervention %K implementation %D 2021 %7 15.12.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Internationally, the implementation of evidence-based healthy eating policies and practices within early childhood education and care (ECEC) settings that encourage children’s healthy diet is recommended. Despite the existence of evidence-based healthy eating practices, research indicates that current implementation rates are inadequate. Web-based approaches provide a potentially effective and less costly approach to support ECEC staff with implementing nutrition policies and practices. Objective: The broad aim of this pilot randomized controlled trial is to assess the feasibility of assessing the impact of a web-based program together with health promotion officer (HPO) support on ECEC center implementation of healthy eating policies and practices. Specifically, we seek to describe the completion rate of study evaluation processes (participant consent and data collection rates); examine ECEC center uptake, acceptability, and appropriateness of the intervention and implementation strategies; understand the potential cost of delivering and receiving implementation support strategies; and describe the potential impact of the web-based intervention on the implementation of targeted healthy eating practices among centers in the intervention group. Methods: A 6-month pilot implementation trial using a cluster-randomized controlled trial design was conducted in 22 ECEC centers within the Hunter New England region of New South Wales, Australia. Potentially eligible centers were distributed a recruitment package and telephoned by the research team to assess eligibility and obtain consent. Centers randomly allocated to the intervention group received access to a web-based program, together with HPO support (eg, educational outreach visit and local technical assistance) to implement 5 healthy eating practices. The web-based program incorporated audit with feedback, development of formal implementation blueprints, and educational materials to facilitate improvement in implementation. The centers allocated to the control group received the usual care. Results: Of the 57 centers approached for the study, 22 (47%) provided consent to participate. Data collection components were completed by 100% (22/22) of the centers. High uptake for implementation strategies provided by HPOs (10/11, 91% to 11/11, 100%) and the web-based program (11/11, 100%) was observed. At follow-up, intervention centers had logged on to the program at an average of 5.18 (SD 2.52) times. The web-based program and implementation support strategies were highly acceptable (10/11, 91% to 11/11, 100%). Implementation of 4 healthy eating practices improved in the intervention group, ranging from 19% (2/11) to 64% (7/11). Conclusions: This study provides promising pilot data to warrant the conduct of a fully powered implementation trial to assess the impact of the program on ECEC healthy eating practice implementation. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619001158156; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378099 International Registered Report Identifier (IRRID): RR2-10.1186/s40814-020-00707-w %M 34914617 %R 10.2196/25902 %U https://www.jmir.org/2021/12/e25902 %U https://doi.org/10.2196/25902 %U http://www.ncbi.nlm.nih.gov/pubmed/34914617 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e26381 %T mUzima Mobile Electronic Health Record (EHR) System: Development and Implementation at Scale %A Were,Martin Chieng %A Savai,Simon %A Mokaya,Benard %A Mbugua,Samuel %A Ribeka,Nyoman %A Cholli,Preetam %A Yeung,Ada %+ Department of Biomedical Informatics, Vanderbilt University Medical Center, 2525 West End Avenue, Suite 750, Nashville, TN, 37203, United States, 1 615 322 9374, martin.c.were@vumc.org %K mobile health %K electronic medical records %K developing countries %K digital divide %K digital health %K global health %D 2021 %7 14.12.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The predominant implementation paradigm of electronic health record (EHR) systems in low- and middle-income countries (LMICs) relies on standalone system installations at facilities. This implementation approach exacerbates the digital divide, with facilities in areas with inadequate electrical and network infrastructure often left behind. Mobile health (mHealth) technologies have been implemented to extend the reach of digital health, but these systems largely add to the problem of siloed patient data, with few seamlessly interoperating with the EHR systems that are now scaled nationally in many LMICs. Robust mHealth applications that effectively extend EHR systems are needed to improve access, improve quality of care, and ameliorate the digital divide. Objective: We report on the development and scaled implementation of mUzima, an mHealth extension of the most broadly deployed EHR system in LMICs (OpenMRS). Methods: The “Guidelines for reporting of health interventions using mobile phones: mobile (mHealth) evidence reporting assessment (mERA)” checklist was employed to report on the mUzima application. The World Health Organization (WHO) Principles for Digital Development framework was used as a secondary reference framework. Details of mUzima’s architecture, core features, functionalities, and its implementation status are provided to highlight elements that can be adapted in other systems. Results: mUzima is an open-source, highly configurable Android application with robust features including offline management, deduplication, relationship management, security, cohort management, and error resolution, among many others. mUzima allows providers with lower-end Android smartphones (version 4.4 and above) who work remotely to access historical patient data, collect new data, view media, leverage decision support, conduct store-and-forward teleconsultation, and geolocate clients. The application is supported by an active community of developers and users, with feature priorities vetted by the community. mUzima has been implemented nationally in Kenya, is widely used in Rwanda, and is gaining scale in Uganda and Mozambique. It is disease-agnostic, with current use cases in HIV, cancer, chronic disease, and COVID-19 management, among other conditions. mUzima meets all WHO’s Principles of Digital Development, and its scaled implementation success has led to its recognition as a digital global public good and its listing in the WHO Digital Health Atlas. Conclusions: Greater emphasis should be placed on mHealth applications that robustly extend reach of EHR systems within resource-limited settings, as opposed to siloed mHealth applications. This is particularly important given that health information exchange infrastructure is yet to mature in many LMICs. The mUzima application demonstrates how this can be done at scale, as evidenced by its adoption across multiple countries and for numerous care domains. %M 34904952 %R 10.2196/26381 %U https://www.jmir.org/2021/12/e26381 %U https://doi.org/10.2196/26381 %U http://www.ncbi.nlm.nih.gov/pubmed/34904952 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e27886 %T Web-Based Return of Individual Patient-Reported Outcome Results Among Patients With Lymphoma: Randomized Controlled Trial %A Oerlemans,Simone %A Arts,Lindy Paulina Johanna %A Kieffer,Jacobien M %A Prins,Judith %A Hoogendoorn,Mels %A van der Poel,Marjolein %A Koster,Ad %A Lensen,Chantal %A Stevens,Wendy Bernadina Catharina %A Issa,Djamila %A Pruijt,Johannes F M %A Oosterveld,Margriet %A van der Griend,René %A Nijziel,Marten %A Tick,Lidwine %A Posthuma,Eduardus F M %A van de Poll-Franse,Lonneke V %+ Department of Research and Development, Netherlands Comprehensive Cancer Organisation, Godebaldkwartier 419, 3511 DT, Utrecht, Netherlands, 31 088 234 60 00, s.oerlemans@iknl.nl %K lymphoma %K patient-reported outcomes %K return of individual results %K randomized controlled trial %K self-management %D 2021 %7 14.12.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: There has been a cultural shift toward patient engagement in health, with a growing demand from patients to access their results. Objective: The Lymphoma Intervention (LIVE) trial is conducted to examine the impact of return of individual patient-reported outcome (PRO) results and a web-based self-management intervention on psychological distress, self-management, satisfaction with information, and health care use in a population-based setting. Methods: Return of PRO results included comparison with age- and sex-matched peers and was built into the Patient-Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship registry. The self-management intervention is an adaptation of a fully automated evidence-based intervention for breast cancer survivors. Patients with lymphoma who completed the web-based questionnaire were equally randomized to care as usual, return of PRO results, and return of PRO results plus self-management intervention. Patients completed questionnaires 9 to 18 months after diagnosis (T0; n=227), 4 months (T1; n=190), 12 months (T2; n=170), and 24 months (T3; n=98). Results: Of all invited patients, 51.1% (456/892) responded and web-based participants (n=227) were randomly assigned to care as usual (n=76), return of PRO results (n=74), or return of PRO results and access to Living with lymphoma (n=77). Return of PRO results was viewed by 76.7% (115/150) of those with access. No statistically significant differences were observed for psychological distress, self-management, satisfaction with information provision, and health care use between patients who received PRO results and those who did not (P>.05). Use of the self-management intervention was low (2/76, 3%), and an effect could therefore not be determined. Conclusions: Return of individual PRO results seems to meet patients’ wishes but had no beneficial effects on patient outcome. No negative effects were found when individual PRO results were disclosed, and the return of individual PRO results can therefore be safely implemented in daily clinical practice. Trial Registration: Netherlands Trial Register NTR5953; https://www.trialregister.nl/trial/5790 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-017-1943-2 %M 34904948 %R 10.2196/27886 %U https://www.jmir.org/2021/12/e27886 %U https://doi.org/10.2196/27886 %U http://www.ncbi.nlm.nih.gov/pubmed/34904948 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e30291 %T Long-Term Effects of a Web-Based Low-FODMAP Diet Versus Probiotic Treatment for Irritable Bowel Syndrome, Including Shotgun Analyses of Microbiota: Randomized, Double-Crossover Clinical Trial %A Ankersen,Dorit Vedel %A Weimers,Petra %A Bennedsen,Mette %A Haaber,Anne Birgitte %A Fjordside,Eva Lund %A Beber,Moritz Emanuel %A Lieven,Christian %A Saboori,Sanaz %A Vad,Nicolai %A Rannem,Terje %A Marker,Dorte %A Paridaens,Kristine %A Frahm,Suzanne %A Jensen,Lisbeth %A Rosager Hansen,Malte %A Burisch,Johan %A Munkholm,Pia %+ Department of Gastroenterology, North Zealand University Hospital, Frederikssundsvej 30, Frederikssund, 3600, Denmark, 45 48292078, pia.munkholm@regionh.dk %K irritable bowel syndrome %K web-based low-FODMAP diet %K probiotics %K randomized trial %K web-based %K IBS %K symptom management %K treatment outcomes %K outcomes %K treatment %K microbiota %K microbiome %K gastroenterology %K mobile app %K mHealth %K eHealth %D 2021 %7 14.12.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The long-term management of irritable bowel syndrome (IBS) poses many challenges. In short-term studies, eHealth interventions have been demonstrated to be safe and practical for at-home monitoring of the effects of probiotic treatments and a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs). IBS has been linked to alterations in the microbiota. Objective: The aim of this study was to determine whether a web-based low-FODMAP diet (LFD) intervention and probiotic treatment were equally good at reducing IBS symptoms, and whether the response to treatments could be explained by patients’ microbiota. Methods: Adult IBS patients were enrolled in an open-label, randomized crossover trial (for nonresponders) with 1 year of follow-up using the web application IBS Constant Care (IBS CC). Patients were recruited from the outpatient clinic at the Department of Gastroenterology, North Zealand University Hospital, Denmark. Patients received either VSL#3 for 4 weeks (2 × 450 billion colony-forming units per day) or were placed on an LFD for 4 weeks. Patients responding to the LFD were reintroduced to foods high in FODMAPs, and probiotic responders received treatments whenever they experienced a flare-up of symptoms. Treatment response and symptom flare-ups were defined as a reduction or increase, respectively, of at least 50 points on the IBS Severity Scoring System (IBS-SSS). Web-based ward rounds were performed daily by the study investigator. Fecal microbiota were analyzed by shotgun metagenomic sequencing (at least 10 million 2 × 100 bp paired-end sequencing reads per sample). Results: A total of 34 IBS patients without comorbidities and 6 healthy controls were enrolled in the study. Taken from participating subjects, 180 fecal samples were analyzed for their microbiota composition. Out of 21 IBS patients, 12 (57%) responded to the LFD and 8 (38%) completed the reintroduction of FODMAPs. Out of 21 patients, 13 (62%) responded to their first treatment of VSL#3 and 7 (33%) responded to multiple VSL#3 treatments. A median of 3 (IQR 2.25-3.75) probiotic treatments were needed for sustained symptom control. LFD responders were reintroduced to a median of 14.50 (IQR 7.25-21.75) high-FODMAP items. No significant difference in the median reduction of IBS-SSS for LFD versus probiotic responders was observed, where for LFD it was –126.50 (IQR –196.75 to –76.75) and for VSL#3 it was –130.00 (IQR –211.00 to –70.50; P>.99). Responses to either of the two treatments were not able to be predicted using patients’ microbiota. Conclusions: The web-based LFD intervention and probiotic treatment were equally efficacious in managing IBS symptoms. The response to treatments could not be explained by the composition of the microbiota. The IBS CC web application was shown to be practical, safe, and useful for clinical decision making in the long-term management of IBS. Although this study was underpowered, findings from this study warrant further research in a larger sample of patients with IBS to confirm these long-term outcomes. Trial Registration: ClinicalTrials.gov NCT03586622; https://clinicaltrials.gov/ct2/show/NCT03586622 %M 34904950 %R 10.2196/30291 %U https://www.jmir.org/2021/12/e30291 %U https://doi.org/10.2196/30291 %U http://www.ncbi.nlm.nih.gov/pubmed/34904950 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e30151 %T One-Year Remission Rate of Chronic Headache Comparing Video and Face-to-Face Consultations by Neurologist: Randomized Controlled Trial %A Bekkelund,Svein Ivar %A Müller,Kai Ivar %+ Department of Clinical Medicine, The Arctic University of Norway, Hansine Hansens veg 18, Tromsø, 9037, Norway, 47 90185090, svein-ivar.bekkelund@uit.no %K chronic headache %K remission %K video consultation %K telemedicine %K eHealth %K digital consultation %K consultation %K treatment %K follow-up %K RCT %K randomized controlled trial %D 2021 %7 13.12.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic headache causing severe headache-related disability for those affected by the disease is under- or misdiagnosed in many cases and therefore requires easy access to a specialist for optimal health care management. Objective: The goal of the research is to determine whether video consultations are noninferior to face-to-face consultations in treating chronic headache patients referred to a specialist in Northern Norway. Methods: Patients included in the study were recruited from general practice referrals to a specialist at a neurological department in Northern Norway (Tromsø) and diagnosed according to the International Headache Society classification system. In a randomized controlled design, the 1-year remission rate of chronic headache (change from ≥15 to <15 headache days per month during the last 3 months), patient satisfaction with a specialist consultation, and need for follow-up consultations by general practitioners were compared between groups consulted by video and face-to-face in a post hoc analysis. Data were collected by interview (baseline) and questionnaire (follow-up). Results: From a baseline cohort of 402 headache patients consecutively referred from general practice to a specialist over 2.5 years, 58.0% (233/402) were classified as chronic headache and included in this study. Response rates were 71.7% (86/120) in the video group and 67.3% (76/113) in the face-to-face group. One-year remission from chronic headache was achieved in 43.0% (37/86) in the video group and 39.5% (30/76) in the face-to-face group (P=.38). Patient satisfaction with consultations were 86.5% (32/37; video) and 93.3% (28/30; face-to-face; P=.25). A total of 30% (11/37) in the video group and 53% (16/30) in the face-to-face group consulted general practitioners during the follow-up period (P=.03), and median number of consultations was 1 (IQR 0-13) and 1.5 (IQR 0-15), respectively (P=.19). Conclusions: One-year remission rate from chronic headache was about 40% regardless of consultation form. Likewise, patient satisfaction with consultation and need for follow-up visits in general practice post consultation was similar. Treating chronic headache patients by using video consultations is not inferior to face-to-face consultations and may be used in clinical neurological practice. Trial Registration: ClinicalTrials.gov NCT02270177; https://clinicaltrials.gov/ct2/show/NCT02270177 %M 34898455 %R 10.2196/30151 %U https://www.jmir.org/2021/12/e30151 %U https://doi.org/10.2196/30151 %U http://www.ncbi.nlm.nih.gov/pubmed/34898455 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e31293 %T Effectiveness of Videoconference-Delivered Cognitive Behavioral Therapy for Adults With Psychiatric Disorders: Systematic and Meta-Analytic Review %A Matsumoto,Kazuki %A Hamatani,Sayo %A Shimizu,Eiji %+ Research Center for Child Mental Development, Chiba University, 1-8-1, Inohana, Chuo-ku,, Chiba, Japan, 81 43 226 2975, axpa0219@chiba-u.jp %K videoconference-delivered cognitive behavioral therapy %K depression %K anxiety %K psychiatric disorders %K systematic review %K meta-analysis %K digital health %K mental health %K cognitive therapy %K internet-based therapy %K cognition %K neurodevelopment %K communication technology %K health technology %K psychological disorders %K anxiety disorder %D 2021 %7 13.12.2021 %9 Review %J J Med Internet Res %G English %X Background: Cognitive behavioral therapy (CBT) is the gold standard of psychotherapy for psychiatric disorders. However, the format of delivering CBT in person limits access to the intervention. The advancements in information and communication technology, especially the internet, present an opportunity for cognitive behavioral therapists to service patients or clients in remote areas through videoconferencing. Although many randomized controlled trials of videoconference-delivered cognitive behavioral therapy (VCBT) have already been conducted, the overall estimated effect size of VCBT for psychiatric disorders has not been examined by systematic reviews and meta-analyses. Objective: This study attempts to evaluate the effectiveness of VCBT for psychiatric disorders through a systematic and meta-analytic review. Methods: A systematic review and meta-analysis of studies in which VCBT was directly compared to control groups (such as treatment as usual, attention control, wait-list control, and other minimal supports) was carried out. To identify previous studies that meet our study objective, 2 independent reviewers undertook a systematic search through seven databases: MEDLINE (via PubMed), Web of Science, Science Direct, PsycINFO, CINAHL, LILACS, and SciELO. Other databases (ClinicalTrials.gov and Cochrane Central Resister of Controlled Trials) were also checked. All studies included in the review were assessed using the quality criteria of the Cochrane Collaboration. Statistical analysis was performed by using Cochrane Review Manager (RevMan, version 5.4.0). Standardized mean difference was used in major meta-analyses where a P value of .05 or less was the threshold for statistical significance. A heterogeneity test and the chi-square test were performed to assess the presence and extent of statistical heterogeneity with significance set at P<.10. Funnel plots were visually inspected to assess the risk of bias. Subgroup analyses were conducted for each disorder to estimate intervention effects. Results: The systematic search resulted in 16 studies (total N=1745) that met the criteria for this study and were included in the review. There were 10 studies on depressive symptoms, 3 on chronic pain, 1 on generalized anxiety disorder, 1 on obsessive-compulsive disorder, and 1 on hypochondriasis. The quality and risk of bias was also assessed. Results showed a pooled effect size (Hedge g) post treatment of −0.49 (95% CI –0.68 to –0.29), indicating that VCBT is effective for clients with psychiatric disorders. Study quality did not affect outcomes. Conclusions: While the overall results indicate the effectiveness of VCBT, there are still only a limited number of studies on specific psychiatric and somatic conditions. Therefore, more randomized controlled trials are needed to establish the effectiveness of VCBT for different disorders. Trial Registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42021224832; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=224832 %M 34898445 %R 10.2196/31293 %U https://www.jmir.org/2021/12/e31293 %U https://doi.org/10.2196/31293 %U http://www.ncbi.nlm.nih.gov/pubmed/34898445 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 12 %P e32450 %T The Life Goals Self-Management Mobile App for Bipolar Disorder: Consumer Feasibility, Usability, and Acceptability Study %A Ryan,Kelly A %A Smith,Shawna N %A Yocum,Anastasia K %A Carley,Isabel %A Liebrecht,Celeste %A Navis,Bethany %A Vest,Erica %A Bertram,Holli %A McInnis,Melvin G %A Kilbourne,Amy M %+ Department of Psychiatry, University of Michigan, 2101 Commonwealth Blvd, Suite C, Ann Arbor, MI, 48105, United States, 1 734 936 5524, karyan@umich.edu %K self-management %K app %K bipolar disorder %K symptom management %K mental health %K feasibility %K usability %K acceptability %K intervention %K bipolar %K coping %K survey %K engagement %D 2021 %7 13.12.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Life Goals is an evidence-based self-management intervention that assists individuals with bipolar disorder (BD) by aligning BD symptom coping strategies with their personal goals. The intervention can be availed via in-person and telephonic sessions, and it has been recently developed as an individualized, customizable mobile app. Objective: We examined the feasibility, usability, and acceptability of the Life Goals self-management app among individuals diagnosed with BD who used the app for up to 6 months. Methods: A total of 28 individuals with BD used the Life Goals app on their personal smartphone for 6 months. They completed key clinical outcome measurements of functioning, disability, and psychiatric symptoms at baseline, 3 months, and 6 months, in addition to a poststudy survey about usability and satisfaction. Results: Participants used the app for a median of 25 times (IQR 13-65.75), and for a longer time during the first 3 months of the study. The modules on depression and anxiety were the most frequently used, accounting for 35% and 22% of total usage, respectively. Overall, the study participants found the app useful (15/25, 60%) and easy to use (18/25, 72%), and they reported that the screen displayed the material adequately (22/25, 88%). However, less than half of the participants found the app helpful in managing their health (10/25, 40%) or in making progress on their wellness goals (9/25, 36%). Clinical outcomes showed a trend for improvements in mental and physical health and mania-related well-being. Conclusions: The Life Goals app showed feasibility of use among individuals with BD. Higher user engagement was observed in the initial 3 months with users interested more frequently in the mood modules than other wellness modules. Participants reported acceptability with the ease of app use and satisfaction with the app user interface, but the app showed low success in encouraging self-management within this small sample. The Life Goals app is a mobile health technology that can provide individuals with serious mental illness with more flexible access to evidence-based treatments. %M 34898452 %R 10.2196/32450 %U https://formative.jmir.org/2021/12/e32450 %U https://doi.org/10.2196/32450 %U http://www.ncbi.nlm.nih.gov/pubmed/34898452 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 12 %P e25129 %T Behavioral Theories and Motivational Features Underlying eHealth Interventions for Adolescent Antiretroviral Adherence: Systematic Review %A Bezabih,Alemitu Mequanint %A Gerling,Kathrin %A Abebe,Workeabeba %A Abeele,Vero Vanden %+ Department of Computer Science, e-Media Research Lab, Katholieke Universiteit Leuven, Andreas Vesaliusstraat 13, Leuven, 3000, Belgium, 32 0485949954, alem.bezabih@kuleuven.be %K HIV %K adolescents %K ART adherence %K eHealth %K health theories %K behavior change techniques %K motivational design principles %D 2021 %7 10.12.2021 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: eHealth systems provide new opportunities for the delivery of antiretroviral therapy (ART) adherence interventions for adolescents. They may be more effective if grounded in health behavior theories and behavior change techniques (BCTs). Prior reviews have examined the effectiveness, feasibility, and acceptability of these eHealth systems. However, studies have not systematically explored the use of health behavior theories and BCTs in the design of these applications. Objective: The purpose of this review was to explore whether health behavior theories and BCTs were considered to ground designs of eHealth systems supporting adolescents’ (10-24 years) ART adherence. More specifically, we examined which specific theories and BCTs were applied, and how these BCTs were implemented as design features. Additionally, we investigated the quality and effect of eHealth systems. Methods: A systematic search was performed on IEEE Xplore, ACM, ScienceDirect, PubMed, Scopus, and Web of Science databases from 2000 to 2020. Theory use and BCTs were coded using the Theory Coding Scheme and the Behavior Change Technique Taxonomy version 1 (BCTTv1), respectively. Design features were identified using the lenses of motivational design for mobile health (mHealth). The number of BCTs and design features for each eHealth system and their prevalence across all systems were assessed. Results: This review identified 16 eHealth systems aiming to support ART adherence among adolescents. System types include SMS text message reminders (n=6), phone call reminders (n=3), combined SMS text message and phone call reminders (n=1), electronic adherence monitoring devices (n=3), smartphone apps (n=1), smartphone serious games (n=1), gamified smartphone apps (n=1), leveraging existing social media (n=2), web-based applications (n=1), videoconferencing (n=1), and desktop applications (n=1). Nine were grounded in theory, of which 3 used theories extensively. The impact of adolescent developmental changes on ART adherence was not made explicit. A total of 42 different BCTs and 24 motivational design features were used across systems. Ten systems reported positive effects on 1 or more outcomes; however, of these ten systems, only 3 reported exclusively positive effects on all the outcomes they measured. As much as 6 out of 16 reported purely no effect in all the outcomes measured. Conclusions: Basic applications (SMS text messaging and phone calls) were most frequent, although more advanced systems such as mobile apps and games are also emerging. This review indicated gaps in the use of theory and BCTs, and particularly the impact of developmental changes on ART adherence was not adequately considered. Together with adopting a developmental orientation, future eHealth systems should effectively leverage health theories and consider developing more advanced systems that open the door to using BCTs more comprehensively. Overall, the impact of eHealth systems on adolescent ART adherence and its mediators is promising, but conclusive evidence on effect still needs to be provided. %M 34890353 %R 10.2196/25129 %U https://mhealth.jmir.org/2021/12/e25129 %U https://doi.org/10.2196/25129 %U http://www.ncbi.nlm.nih.gov/pubmed/34890353 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 12 %P e26665 %T Evaluation of Repeated Web-Based Screening for Predicting Postpartum Depression: Prospective Cohort Study %A Haßdenteufel,Kathrin %A Lingenfelder,Katrin %A Schwarze,Cornelia E %A Feisst,Manuel %A Brusniak,Katharina %A Matthies,Lina Maria %A Goetz,Maren %A Wallwiener,Markus %A Wallwiener,Stephanie %+ Department of Obstetrics and Gynecology, Heidelberg University, Im Neuenheimer Feld 440, Heidelberg, D-69120, Germany, 49 62215637551, stephanie.wallwiener@med.uni-heidelberg.de %K postpartum depression %K Edinburgh Postnatal Depression Scale %K screening %K pregnancy %K algorithm %D 2021 %7 10.12.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: Postpartum depression (PPD) is a severe mental disorder that often results in poor maternal-infant attachment and negatively impacts infant development. Universal screening has recently been recommended to identify women at risk, but the optimal screening time during pregnancy has not been defined so far. Thus, web-based technologies with widespread use among women of childbearing age create new opportunities to detect pregnancies with a high risk for adverse mental health outcomes at an early stage. Objective: The aim of this study was to stratify the risk for PPD and to determine the optimal screening time during pregnancy by using a web-based screening tool collecting electronic patient-reported outcomes (ePROs) as the basis for a screening algorithm. Methods: In total, 214 women were repeatedly tested for depressive symptoms 5 times during and 3 times after pregnancy by using the Edinburgh Postnatal Depression Scale (EPDS), accessible on a web-based pregnancy platform, developed by the authors of this study. For each prenatal assessment, the area under the curve (AUC), sensitivity, specificity, and predictive values for PPD were calculated. Multivariate logistic regression analyses were applied to identify further potential predictors, such as age, education, parity, relationship quality, and anxiety, to increase predictive accuracy. Results: Digitally collected data from 214 pregnant women were analyzed. The predictive accuracy of depressive symptoms 3 and 6 months postpartum was reasonable to good regarding the screening in the second (AUC=0.85) and third (AUC=0.75) trimester. The multivariate logistic regression analyses resulted in an excellent AUC of 0.93 at 3 months and a good AUC of 0.87 at 6 months postpartum. Conclusions: The best predictive accuracy for PPD has been shown for screening between the 24th and the 28th gestational week (GW) and seems to be beneficial for identifying women at risk. In combination with the aforementioned predictive factors, the discriminatory power improved, particularly at 3 months postpartum. Screening for depression during pregnancy, combined with the women’s personal risk profile, can be used as a starting point for developing a digital screening algorithm. Thereby, web-based assessment tools constitute feasible, efficient, and cost-effective approaches. Thus, they seem to be beneficial in detecting high-risk pregnancies in order to improve maternal and infant birth outcomes in the long term. %M 34890349 %R 10.2196/26665 %U https://mental.jmir.org/2021/12/e26665 %U https://doi.org/10.2196/26665 %U http://www.ncbi.nlm.nih.gov/pubmed/34890349 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 12 %P e34381 %T An eHealth Intervention for Promoting COVID-19 Knowledge and Protective Behaviors and Reducing Pandemic Distress Among Sexual and Gender Minorities: Protocol for a Randomized Controlled Trial (#SafeHandsSafeHearts) %A Newman,Peter A %A Chakrapani,Venkatesan %A Williams,Charmaine %A Massaquoi,Notisha %A Tepjan,Suchon %A Roungprakhon,Surachet %A Akkakanjanasupar,Pakorn %A Logie,Carmen %A Rawat,Shruta %+ Factor-Inwentash Faculty of Social Work, University of Toronto, 246 Bloor Street West, Toronto, ON, M5S 1V4, Canada, 1 416 946 8611, p.newman@utoronto.ca %K COVID-19 %K eHealth %K RCT %K protective behaviors %K psychological distress %K LGBT+ %K India %K Thailand %D 2021 %7 10.12.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Existing data on COVID-19 disparities among vulnerable populations portend excess risk for lesbian, gay, bisexual, transgender (LGBT) and other persons outside of heteronormative and cisgender identities (ie, LGBT+). Owing to adverse social determinants of health, including pervasive HIV and sexual stigma, harassment, violence, barriers in access to health care, and existing health and mental health disparities, sexual and gender minorities in India and Thailand are at disproportionate risk for SARS-CoV-2 infection and severe disease. Despite global health disparities among LGBT+ populations, there is a lack of coordinated, community-engaged interventions to address the expected excess burden of COVID-19 and public health–recommended protective measures. Objective: We will implement a randomized controlled trial (RCT) to evaluate the effectiveness of a brief, peer-delivered eHealth intervention to increase COVID-19 knowledge and public health–recommended protective behaviors, and reduce psychological distress among LGBT+ people residing in Bangkok, Thailand, and Mumbai, India. Subsequent to the RCT, we will conduct exit interviews with purposively sampled subgroups, including those with no intervention effect. Methods: SafeHandsSafeHearts is a 2-site, parallel waitlist-controlled RCT to test the efficacy of a 3-session, peer counselor–delivered eHealth intervention based on motivational interviewing and psychoeducation. The study methods, online infrastructure, and content were pilot-tested with LGBT+ individuals in Toronto, Canada, before adaptation and rollout in the other contexts. The primary outcomes are COVID-19 knowledge (index based on US Centers for Disease Control and Prevention [CDC] items), protective behaviors (index based on World Health Organization and US CDC guidelines), depression (Patient Health Questionnaire-2), and anxiety (Generalized Anxiety Disorder-2). Secondary outcomes include loneliness, COVID-19 stress, and intended care-seeking. We will enroll 310 participants in each city aged 18 years and older. One-third of the participants will be cisgender gay, bisexual, and other men who have sex with men; one-third will be cisgender lesbian, bisexual, and other women who have sex with women; and one-third will be transfeminine, transmasculine, and gender nonbinary people. Participants will be equally stratified in the immediate intervention and waitlist control groups. Participants are mainly recruited from online social media accounts of community-based partner organizations. They can access the intervention on a computer, tablet, or mobile phone. SafeHandsSafeHearts involves 3 sessions delivered weekly over 3 successive weeks. Exit interviews will be conducted online with 3 subgroups (n=12 per group, n=36 in each city) of purposively selected participants to be informed by RCT outcomes and focal populations of concern. Results: The RCT was funded in 2020. The trials started recruitment as of August 1, 2021, and all RCT data collection will likely be completed by January 31, 2022. Conclusions: The SafeHandsSafeHearts RCT will provide evidence about the effectiveness of a brief, peer-delivered eHealth intervention developed for LGBT+ populations amid the COVID-19 pandemic. If the intervention proves effective, it will provide a basis for future scale-up in India and Thailand, and other low- and middle-income countries. Trial Registration: ClinicalTrials.gov NCT04870723; https://clinicaltrials.gov/ct2/show/NCT04870723 International Registered Report Identifier (IRRID): DERR1-10.2196/34381 %M 34726610 %R 10.2196/34381 %U https://www.researchprotocols.org/2021/12/e34381 %U https://doi.org/10.2196/34381 %U http://www.ncbi.nlm.nih.gov/pubmed/34726610 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 12 %P e29573 %T Mobile Intervention to Improve Sleep and Functional Health of Veterans With Insomnia: Randomized Controlled Trial %A Reilly,Erin Dawna %A Robinson,Stephanie A %A Petrakis,Beth Ann %A Gardner,Melissa M %A Wiener,Renda Soylemez %A Castaneda-Sceppa,Carmen %A Quigley,Karen S %+ Mental Illness Research, Education, and Clinical Center, VA Bedford Healthcare System, 200 Springs Road, Bedford, MA, 01730, United States, 1 781 687 4191, erin.reilly@va.gov %K cognitive behavioral therapy %K mobile app %K physical activity %K insomnia %D 2021 %7 9.12.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Insomnia is a prevalent and debilitating disorder among veterans. Cognitive behavioral therapy for insomnia (CBTI) can be effective for treating insomnia, although many cannot access this care. Technology-based solutions and lifestyle changes, such as physical activity (PA), offer affordable and accessible self-management alternatives to in-person CBTI. Objective: This study aims to extend and replicate prior pilot work to examine whether the use of a mobile app for CBTI (cognitive behavioral therapy for insomnia coach app [CBT-i Coach]) improves subjective and objective sleep outcomes. This study also aims to investigate whether the use of the CBT-i Coach app with adjunctive PA improves sleep outcomes more than CBT-i Coach alone. Methods: A total of 33 veterans (mean age 37.61 years, SD 9.35 years) reporting chronic insomnia were randomized to use either the CBT-i Coach app alone or the CBT-i Coach app with a PA intervention over 6 weeks, with outcome measures of objective and subjective sleep at pre- and posttreatment. Results: Although the PA manipulation was unsuccessful, both groups of veterans using the CBT-i Coach app showed significant improvement from baseline to postintervention on insomnia (P<.001), sleep quality (P<.001), and functional sleep outcomes (P=.002). Improvements in subjective sleep outcomes were similar in those with and without posttraumatic stress disorder and mild-to-moderate sleep apnea. We also observed a significant but modest increase in objective sleep efficiency (P=.02). Conclusions: These findings suggest that the use of a mobile app–delivered CBTI is feasible and beneficial for improving sleep outcomes in veterans with insomnia, including those with comorbid conditions such as posttraumatic stress disorder or mild-to-moderate sleep apnea. Trial Registration: ClinicalTrials.gov NCT03305354; https://clinicaltrials.gov/ct2/show/NCT03305354 %M 34889746 %R 10.2196/29573 %U https://formative.jmir.org/2021/12/e29573 %U https://doi.org/10.2196/29573 %U http://www.ncbi.nlm.nih.gov/pubmed/34889746 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 12 %P e17314 %T Evaluation of a Web-Based Stress Management Program for Persons Experiencing Work-Related Stress in Sweden (My Stress Control): Randomized Controlled Trial %A Eklund,Caroline %A Söderlund,Anne %A Elfström,Magnus L %+ Department of Physical Therapy, School of Health, Care and Social Welfare, Mälardalen University, Box 883, Västerås, 72123, Sweden, 46 736484426, caroline.eklund@mdh.se %K behavior change %K behavior medicine %K internet %K stress prevention %D 2021 %7 9.12.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: Stress is one of the most common reasons for sick leave. Web-based interventions have the potential to reach an unlimited number of users at a low cost and have been shown to be effective in addressing several health-related problems. Handling stress on an individual level is related to behavior change. To support behavioral changes in stress management, My Stress Control (MSC) was developed. The development of MSC was based on several health psychology theories and models; however, central in the development were Social Cognitive Theory, Theory of Reasoned Action, Theory of Planned Behavior, Transactional Theory of Stress and Coping, and the Transtheoretical Model and Stages of Change. MSC is a fully automated program. The program is tailored to the user’s specific needs for stress management and behavior change. Objective: In this study, we aim to conduct a randomized controlled trial to evaluate the extent to which MSC affects perceived stress in persons experiencing work-related stress. Methods: This was a randomized controlled trial with 2 arms. Study participants were recruited by visiting the worksites and workplace meetings. Participants were assigned to the intervention or wait-list group. Web-based questionnaires were used before and after the intervention to collect data. Perceived stress measured using the Perceived Stress Scale-14 was the primary outcome measurement. Analyses were conducted for both between-group and within-group changes. Results: A total of 92 participants were included in this study: 48 (52%) in the intervention group and 44 (48%) in the wait-list group. Overall, 25% (12/48) of participants in the intervention group and 43% (19/44) of participants in the wait-list group completed the postintervention assessment. There were no significant effects on perceived stress between the intervention and wait-list groups or within the groups. A small effect size (Cohen d=0.25) was found when comparing mean change over time on the primary outcome measure between the intervention and wait-list groups. In addition, a small effect size was found between pre- and postintervention assessments within the intervention group (Cohen d=0.38) as well as within the wait-list group (Cohen d=0.25). Conclusions: The effect of MSC on perceived stress remains uncertain. As adherence was low in the intervention group, elements or features that facilitate adherence and engagement must be further developed before firmer conclusions regarding the effect of MSC can be made. Trial Registration: ClinicalTrials.gov NCT03077568; https://clinicaltrials.gov/ct2/show/NCT03077568 %M 34889772 %R 10.2196/17314 %U https://mental.jmir.org/2021/12/e17314 %U https://doi.org/10.2196/17314 %U http://www.ncbi.nlm.nih.gov/pubmed/34889772 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 4 %N 4 %P e27645 %T Technology Support Challenges and Recommendations for Adapting an Evidence-Based Exercise Program for Remote Delivery to Older Adults: Exploratory Mixed Methods Study %A Gell,Nancy %A Hoffman,Elise %A Patel,Kushang %+ Department of Anesthesiology and Pain Medicine, University of Washington, 1959 NE Pacific Street, Box 356540, Seattle, WA, 98195-6540, United States, 1 2066168052, kvpatel@uw.edu %K tele-exercise %K technology %K older adults %K adult learning theory %K knee osteoarthritis %K mobile phone %D 2021 %7 9.12.2021 %9 Original Paper %J JMIR Aging %G English %X Background: Tele-exercise has emerged as a means for older adults to participate in group exercise during the COVID-19 pandemic. However, little is known about the technology support needs of older adults for accessing tele-exercise. Objective: This study aims to examine the needs of older adults for transition to tele-exercise, identify barriers to and facilitators of tele-exercise uptake and continued participation, and describe technology support challenges and successes encountered by older adults starting tele-exercise. Methods: We used an exploratory, sequential mixed methods study design. Participants were older adults with symptomatic knee osteoarthritis (N=44) who started participating in a remotely delivered program called Enhance Fitness. Before the start of the classes, a subsample of the participants (n=10) completed semistructured phone interviews about their technology support needs and the barriers to and facilitators for technology adoption. All of the participants completed the surveys including the Senior Technology Acceptance Model scale and a technology needs assessment. The study team recorded the technology challenges encountered and the attendance rates for 48 sessions delivered over 16 weeks. Results: Four themes emerged from the interviews: participants desire features in a tele-exercise program that foster accountability, direct access to helpful people who can troubleshoot and provide guidance with technology is important, opportunities to participate in high-value activities motivate willingness to persevere through the technology concerns, and belief in the ability to learn new things supersedes technology-related frustration. Among the participants in the tele-exercise classes (mean age 74, SD 6.3 years; 38/44, 86% female; mean 2.5, SD 0.9 chronic conditions), 71% (31/44) had a computer with a webcam, but 41% (18/44) had little or no experience with videoconferencing. The initial technology orientation sessions lasted on average 19.3 (SD 10.3) minutes, and 24% (11/44) required a follow-up assistance call. During the first 2 weeks of tele-exercise, 47% of participants (21/44) required technical assistance, which decreased to 12% (5/44) during weeks 3 to 16. The median attendance was 100% for the first 6 sessions and 93% for the subsequent 42 sessions. Conclusions: With appropriate support, older adults can successfully participate in tele-exercise. Recommendations include individualized technology orientation sessions, experiential learning, and availability of standby technical assistance, particularly during the first 2 weeks of classes. Continued development of best practices in this area may allow previously hard-to-reach populations of older adults to participate in health-enhancing, evidence-based exercise programs. %M 34889743 %R 10.2196/27645 %U https://aging.jmir.org/2021/4/e27645 %U https://doi.org/10.2196/27645 %U http://www.ncbi.nlm.nih.gov/pubmed/34889743 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 12 %P e31995 %T A Web-Based Service Delivery Model for Communication Training After Brain Injury: Protocol for a Mixed Methods, Prospective, Hybrid Type 2 Implementation-Effectiveness Study %A Miao,Melissa %A Power,Emma %A Rietdijk,Rachael %A Brunner,Melissa %A Debono,Deborah %A Togher,Leanne %+ University of Technology Sydney, PO Box 123 Broadway, Ultimo, Sydney, 2007, Australia, 61 2 95147348, melissa.miao@uts.edu.au %K implementation science %K patient-outcome assessment %K internet interventions %K acquired brain injury %K delivery of health care %K caregivers %K speech-language pathology %D 2021 %7 9.12.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Acquired brain injuries (ABIs) commonly cause cognitive-communication disorders, which can have a pervasive psychosocial impact on a person’s life. More than 135 million people worldwide currently live with ABI, and this large and growing burden is increasingly surpassing global rehabilitation service capacity. A web-based service delivery model may offer a scalable solution. The Social Brain Toolkit is an evidence-based suite of 3 web-based communication training interventions for people with ABI and their communication partners. Successful real-world delivery of web-based interventions such as the Social Brain Toolkit requires investigation of intervention implementation in addition to efficacy and effectiveness. Objective: The aim of this study is to investigate the implementation and effectiveness of the Social Brain Toolkit as a web-based service delivery model. Methods: This is a mixed methods, prospective, hybrid type 2 implementation-effectiveness study, theoretically underpinned by the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework of digital health implementation. We will document implementation strategies preemptively deployed to support the launch of the Social Brain Toolkit interventions, as well as implementation strategies identified by end users through formative evaluation of the Social Brain Toolkit. We will prospectively observe implementation outcomes, selected on the basis of the NASSS framework, through quantitative web analytics of intervention use, qualitative and quantitative pre- and postintervention survey data from all users within a specified sample frame, and qualitative interviews with a subset of users of each intervention. Qualitative implementation data will be deductively analyzed against the NASSS framework. Quantitative implementation data will be analyzed descriptively. We will obtain effectiveness outcomes through web-based knowledge tests, custom user questionnaires, and formal clinical tools. Quantitative effectiveness outcomes will be analyzed through descriptive statistics and the Reliable Change Index, with repeated analysis of variance (pretraining, posttraining, and follow-up), to determine whether there is any significant improvement within this participant sample. Results: Data collection commenced on July 2, 2021, and is expected to conclude on June 1, 2022, after a 6-month sample frame of analytics for each Social Brain Toolkit intervention. Data analysis will occur concurrently with data collection until mid-2022, with results expected for publication late 2022 and early 2023. Conclusions: End-user evaluation of the Social Brain Toolkit’s implementation can guide intervention development and implementation to reach and meet community needs in a feasible, scalable, sustainable, and acceptable manner. End user feedback will be directly incorporated and addressed wherever possible in the next version of the Social Brain Toolkit. Learnings from these findings will benefit the implementation of this and future web-based psychosocial interventions for people with ABI and other populations. Trial Registration: Australia and New Zealand Clinical Trials Registry ACTRN12621001170819; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12621001170819, Australia and New Zealand Clinical Trials Registry ACTRN12621001177842; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12621001177842, Australia and New Zealand Clinical Trials Registry ACTRN12621001180808; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12621001180808 International Registered Report Identifier (IRRID): DERR1-10.2196/31995 %M 34889770 %R 10.2196/31995 %U https://www.researchprotocols.org/2021/12/e31995 %U https://doi.org/10.2196/31995 %U http://www.ncbi.nlm.nih.gov/pubmed/34889770 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e17185 %T Internet and Face-to-face Cognitive Behavioral Therapy for Postnatal Depression Compared With Treatment as Usual: Randomized Controlled Trial of MumMoodBooster %A Milgrom,Jeannette %A Danaher,Brian G %A Seeley,John R %A Holt,Christopher J %A Holt,Charlene %A Ericksen,Jennifer %A Tyler,Milagra S %A Gau,Jeff M %A Gemmill,Alan W %+ Parent-Infant Research Institute, Heidelberg Repatriation Hospital, 300 Waterdale Rd, Heidelberg Heights, 3081, Australia, 61 3 9496 4496, alan.gemmill@austin.org.au %K postnatal depression %K postpartum depression %K postnatal anxiety %K postpartum anxiety %K cognitive behavioral therapy %K internet intervention %K web-based intervention %K randomized controlled trial %K online intervention %K treatment %K mobile phone %D 2021 %7 8.12.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Previous research has confirmed that symptoms of postnatal depression (PND) can be ameliorated through internet-delivered psychological interventions. Advantages of internet-delivered treatment include anonymity, convenience, and catering to women who are unable to access face-to-face (FTF) treatments. To date, no research has examined the efficacy of such interventions compared directly with FTF treatments in women clinically diagnosed with PND. Objective: This study aims to compare the efficacy of one of the first web-based cognitive behavioral therapy (CBT) interventions (internet CBT+coach calls) for PND (MumMoodBooster [MMB]) with FTF-CBT in a randomized controlled trial (RCT). Methods: In this study, 116 postnatal women with a Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition (DSM-IV) diagnosis of major or minor depression were randomized to MMB (39/116, 33.6%), FTF-CBT (39/116, 33.6%), or a treatment-as-usual (TAU) control condition (38/116, 32.8%). Diagnostic status was determined at baseline and at 21-week follow-up using the Structured Clinical Interview for the DSM-IV. Severity of anxiety and depressive symptoms was evaluated using the Depression Anxiety Stress Scales and the revised Beck Depression Inventory at baseline, 12-week follow-up (after treatment), and 21-week follow-up. Results: Of the 116 participants, 107 (92.2%) had a diagnosis of major depression at baseline. Rates of remission from a major or minor depressive episode at 21 weeks in both the FTF-CBT and MMB groups were superior to that of the TAU group (56.6% and 47.7% less likely to be depressed, respectively) and they were not significantly different from each other. Although remission rates differed between TAU and FTF-CBT, growth models showed that, in terms of symptom reduction across time, the FTF-CBT treatment was not significantly better than TAU. By comparison, MMB was statistically superior to both TAU and FTF-CBT in reducing symptoms of depression, anxiety, and stress from baseline to the 21-week follow-up (large and moderate effect sizes). Thus, after 21 weeks, the average symptom scores for depression and anxiety of women receiving MMB were approximately half those of women in both the TAU and FTF-CBT groups. Conclusions: In this RCT, MMB was at least as effective as FTF-CBT in achieving remission from a diagnosed PND episode. MMB was superior to TAU and FTF-CBT in encouraging and maintaining reduction of symptom severity over the 21-week follow-up for depressed postnatal women. These findings replicate results of prior studies on MMB that showed clinically significant improvements in depressive symptoms, and they provide direct empirical support that internet-delivered treatment for depressed postnatal women is a viable alternative to FTF treatment. The generalizability of the results needs to be examined in future research, as RCTs of internet-based versus FTF treatments necessarily involve a subset of people who are willing to undertake either modality of treatment. Trial Registration: Australia and New Zealand Clinical Trials Registry (ANZCTR) ACTRN12613000881730; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364683&isReview=true %M 34889742 %R 10.2196/17185 %U https://www.jmir.org/2021/12/e17185 %U https://doi.org/10.2196/17185 %U http://www.ncbi.nlm.nih.gov/pubmed/34889742 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 12 %P e29661 %T Effectiveness and Feasibility of Internet-Based Interventions for Grief After Bereavement: Systematic Review and Meta-analysis %A Zuelke,Andrea E %A Luppa,Melanie %A Löbner,Margrit %A Pabst,Alexander %A Schlapke,Christine %A Stein,Janine %A Riedel-Heller,Steffi G %+ Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, Philipp-Rosenthal-Str. 55, Leipzig, 04103, Germany, 49 3419715483, andrea.zuelke@medizin.uni-leipzig.de %K grief %K systematic review %K meta-analysis %K internet-based %K online therapy %D 2021 %7 8.12.2021 %9 Review %J JMIR Ment Health %G English %X Background: Although grief and its symptoms constitute a normal reaction to experiences of loss, some of those affected still report elevated levels of distress after an extended period, often termed complicated grief. Beneficial treatment effects of face-to-face therapies, for example, grief counseling or cognitive behavioral therapy against complicated grief, have been reported. Evaluations of internet- and mobile-based interventions targeting symptoms of grief in bereaved individuals with regard to objective quality criteria are currently lacking. Objective: We aim to conduct a systematic review and meta-analysis on the effectiveness and feasibility of internet- and mobile-based interventions against symptoms of grief after bereavement. Methods: We conducted systematic literature searches of randomized controlled trials or feasibility studies published before January 9, 2020, following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, in PubMed, PsycINFO, Web of Science Core Collection, and the Cochrane Library. The quality of evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluations system. We further assessed aspects of feasibility and rated quality of interventions using criteria suggested by an expert panel on mental health care (German Association for Psychiatry, Psychotherapy, and Psychosomatics). A random-effects meta-analysis was conducted to assess between-group effect sizes. Results: In total, 9 trials (N=1349) were included. Of these, 7 studies were analyzed meta-analytically. Significant effects were found for symptoms of grief (g=0.54, 95% CI 0.32-0.77), depression (g=0.44, 95% CI 0.20-0.68), and posttraumatic stress (g=0.82, 95% CI 0.63-1.01). Heterogeneity was moderate for grief and depression (I2=48.75% and 55.19%, respectively) and low for posttraumatic stress symptoms (I2=0%). The overall quality of evidence was graded low (grief and depression) to moderate (posttraumatic stress). User satisfaction with the interventions was high, as was the quality of the interventions assessed using objective quality criteria. Conclusions: Internet- or mobile-based interventions might constitute an effective treatment approach against symptoms of grief in bereaved adults. However, the small sample sizes and limited number of studies included in the review warrant further investigation. Trial Registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42012002100; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=131428 %M 34889769 %R 10.2196/29661 %U https://mental.jmir.org/2021/12/e29661 %U https://doi.org/10.2196/29661 %U http://www.ncbi.nlm.nih.gov/pubmed/34889769 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e31917 %T A Theory-Based, Multidisciplinary Approach to Cocreate a Patient-Centric Digital Solution to Enhance Perioperative Health Outcomes Among Colorectal Cancer Patients and Their Family Caregivers: Development and Evaluation Study %A Wan,Su Wei %A Chong,Choon Seng %A Toh,Ee-Lin %A Lim,Siew Hoon %A Loi,Carol TT %A Lew,Yuen Foong Henry %A Chua,Matthew Chin Heng %A Jee,Xin Pei %A Liu,Guangyu %A Zhu,Lixia %A Pikkarainen,Minna %A He,Hong-Gu %+ Alice Lee Centre for Nursing Studies, National University of Singapore, Level 2, Clinical Research Centre, Block MD11, 10 Medical Drive, Singapore, 117597, Singapore, 65 65167448, nurhhg@nus.edu.sg %K colorectal cancer %K digital solutions %K mobile health %K psychosocial %K mHealth %K smartphone app %K mobile phone app %D 2021 %7 7.12.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Elective colorectal cancer (CRC) surgeries offer enhanced surgical outcomes but demand high self-efficacy in prehabilitation and competency in self-care and disease management postsurgery. Conventional strategies to meet perioperative needs have not been pragmatic, and there remains a pressing need for novel technologies that could improve health outcomes. Objective: The aim of this paper was to describe the development of a smartphone-based interactive CRC self-management enhancement psychosocial program (iCanManage) in order to improve health outcomes among patients who undergo elective CRC surgeries and their family caregivers. Methods: A multidisciplinary international team comprising physicians, specialist nurses, a psychologist, software engineers, academic researchers, cancer survivors, patient ambassadors, and ostomy care medical equipment suppliers was formed to facilitate the development of this patient-centric digital solution. The process occurred in several stages: (1) review of current practice through clinic visits and on-site observations; (2) review of literature and findings from preliminary studies; (3) content development grounded in an underpinning theory; (4) integration of support services; and (5) optimizing user experience through improving interface aesthetics and customization. In our study, 5 participants with CRC performed preliminary assessments on the quality of the developed solution using the 20-item user version of the Mobile App Rating Scale (uMARS), which had good psychometric properties. Results: Based on the collected uMARS data, the smartphone app was rated highly for functionality, aesthetics, information quality, and perceived impact, and moderately for engagement and subjective quality. Several limiting factors such as poor agility in the adoption of digital technology and low eHealth literacy were identified despite efforts to promote engagement and ensure ease of use of the mobile app. To overcome such barriers, additional app-training sessions, an instruction manual, and regular telephone calls will be incorporated into the iCanManage program during the trial period. Conclusions: This form of multidisciplinary collaboration is advantageous as it can potentially streamline existing care paths and allow the delivery of more holistic care to the CRC population during the perioperative period. Should the program be found to be effective and sustainable, hospitals adopting this digital solution may achieve better resource allocation and reduce overall health care costs in the long run. Trial Registration: ClinicalTrials.gov NCT04159363; https://clinicaltrials.gov/ct2/show/NCT04159363 %M 34878991 %R 10.2196/31917 %U https://www.jmir.org/2021/12/e31917 %U https://doi.org/10.2196/31917 %U http://www.ncbi.nlm.nih.gov/pubmed/34878991 %0 Journal Article %@ 2291-9694 %I JMIR Publications %V 9 %N 12 %P e23285 %T A Smartphone App (AnSim) With Various Types and Forms of Messages Using the Transtheoretical Model for Cardiac Rehabilitation in Patients With Coronary Artery Disease: Development and Usability Study %A Choi,Jah Yeon %A Kim,Ji Bak %A Lee,Sunki %A Lee,Seo-Joon %A Shin,Seung Eon %A Park,Se Hyun %A Park,Eun Jin %A Kim,Woohyeun %A Na,Jin Oh %A Choi,Cheol Ung %A Rha,Seung-Woon %A Park,Chang Gyu %A Seo,Hong Seog %A Ahn,Jeonghoon %A Jeong,Hyun-Ghang %A Kim,Eung Ju %+ Sports Medical Center, Korea University Guro Hospital, Seoul, 08308, Republic of Korea, 82 2 2626 3020, withnoel@empas.com %K cardiac rehabilitation %K smartphone app %K coronary heart disease %D 2021 %7 7.12.2021 %9 Original Paper %J JMIR Med Inform %G English %X Background: Despite strong evidence of clinical benefit, cardiac rehabilitation (CR) programs are currently underutilized and smartphone-based CR strategies are thought to address this unmet need. However, data regarding the detailed process of development are scarce. Objective: This study focused on the development of a smartphone-based, patient-specific, messaging app for patients who have undergone percutaneous coronary intervention (PCI). Methods: The AnSim app was developed in collaboration with a multidisciplinary team that included cardiologists, psychiatrists, nurses, pharmacists, nutritionists, and rehabilitation doctors and therapists. First, a focus group interview was conducted, and the narratives of the patients were analyzed to identify their needs and preferences. Based on the results, health care experts and clinicians drafted messages into 5 categories: (1) general information regarding cardiovascular health and medications, (2) nutrition, (3) physical activity, (4) destressing, and (5) smoking cessation. In each category, 90 messages were developed according to 3 simplified steps of the transtheoretical model of behavioral change: (1) precontemplation, (2) contemplation and preparation, and (3) action and maintenance. After an internal review and feedback from potential users, a bank of 450 messages was developed. Results: The focus interview was conducted with 8 patients with PCI within 1 year, and 450 messages, including various forms of multimedia, were developed based on the transtheoretical model of behavioral change in each category. Positive feedback was obtained from the potential users (n=458). The mean Likert scale score was 3.95 (SD 0.39) and 3.91 (SD 0.39) for readability and usefulness, respectively, and several messages were refined based on the feedback. Finally, the patient-specific message delivery system was developed according to the baseline characteristics and stages of behavioral change in each participant. Conclusions: We developed an app (AnSim), which includes a bank of 450 patient-specific messages, that provides various medical information and CR programs regarding coronary heart disease. The detailed process of multidisciplinary collaboration over the course of the study provides a scientific basis for various medical professionals planning smartphone-based clinical research. %M 34878987 %R 10.2196/23285 %U https://medinform.jmir.org/2021/12/e23285 %U https://doi.org/10.2196/23285 %U http://www.ncbi.nlm.nih.gov/pubmed/34878987 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 12 %P e26185 %T The Effects of the ManageHF4Life Mobile App on Patients With Chronic Heart Failure: Randomized Controlled Trial %A Dorsch,Michael P %A Farris,Karen B %A Rowell,Brigid E %A Hummel,Scott L %A Koelling,Todd M %+ Department of Clinical Pharmacy, College of Pharmacy, University of Michigan, 428 Church St, Ann Arbor, MI, 48109, United States, 1 734 647 1452, mdorsch@med.umich.edu %K mHealth %K remote monitoring %K self-management %K self-care %K heart failure %K medical therapy %K mobile app %D 2021 %7 7.12.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The successful management of heart failure (HF) involves guideline-based medical therapy as well as self-management behavior. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. Objective: The aim of this paper was to evaluate the efficacy of enhanced self-management via a mobile app intervention on health-related quality of life, self-management, and HF readmissions. Methods: A single-center randomized controlled trial was performed. Participants older than 45 years and admitted for acute decompensated HF or recently discharged in the past 4 weeks were included. The intervention group (“app group”) used a mobile app, and the intervention prompted daily self-monitoring and promoted self-management. The control group (“no-app group”) received usual care. The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score from baseline to 6 and 12 weeks. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire score and recurrent HF admissions. Results: A total of 83 participants were enrolled and completed all baseline assessments. Baseline characteristics were similar between the groups except for the prevalence of ischemic HF. The app group had a reduced MLHFQ at 6 weeks (mean 37.5, SD 3.5 vs mean 48.2, SD 3.7; P=.04) but not at 12 weeks (mean 44.2, SD 4 vs mean 45.9, SD 4; P=.78), compared to the no-app group. There was no effect of the app on the SCHFI at 6 or 12 weeks. The time to first HF readmission was not statistically different between the app group and the no-app group (app group 11/42, 26% vs no-app group 12/41, 29%; hazard ratio 0.89, 95% CI 0.39-2.02; P=.78) over 12 weeks. Conclusions: The adaptive mobile app intervention, which focused on promoting self-monitoring and self-management, improved the MLHFQ at 6 weeks but did not sustain its effects at 12 weeks. No effect was seen on HF self-management measured by self-report. Further research is needed to enhance engagement in the app for a longer period and to determine if the app can reduce HF readmissions in a larger study. Trial Registration: ClinicalTrials.gov NCT03149510; https://clinicaltrials.gov/ct2/show/NCT03149510 %M 34878990 %R 10.2196/26185 %U https://mhealth.jmir.org/2021/12/e26185 %U https://doi.org/10.2196/26185 %U http://www.ncbi.nlm.nih.gov/pubmed/34878990 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 4 %N 4 %P e17959 %T The Role of Education, Monitoring, and Symptom Perception in Internet-Based Self-management Among Adolescents With Asthma: Secondary Analysis of a Randomized Controlled Trial %A Beerthuizen,Thijs %A Rikkers-Mutsaerts,E R V M %A Snoeck-Stroband,Jiska B %A Sont,Jacob K %+ Department of Biomedical Data Sciences, Medical Decision Making, Leiden University Medical Center, Albinusdreef 2, J-10-S, Leiden, 2333ZA, Netherlands, 31 715264578, j.k.sont@lumc.nl %K web-based monitoring %K internet self-management %K adolescents %K asthma %K education %K perception %D 2021 %7 7.12.2021 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Internet-based self-management programs improve asthma control and the asthma-related quality of life in adults and adolescents. The components of self-management programs include education and the web-based self-monitoring of symptoms; the latter requires adequate perception in order to timely adjust lifestyle or medication or to contact a care provider. Objective: We aimed to test the hypothesis that adherence to education and web-based monitoring and adequate symptom perception are important determinants for the improvement of asthma control in self-management programs. Methods: We conducted a subgroup analysis of the intervention group of a randomized controlled trial, which included adolescents who participated in the internet-based self-management arm. We assessed the impacts that attendance in education sessions, the frequency of web-based monitoring, and the level of perception had on changes in asthma control (Asthma Control Questionnaire [ACQ]) and asthma-related quality of life (Pediatric Asthma Quality of Life Questionnaire) from baseline to 12 months after intervention. Results: Adolescents who attended education sessions had significant and clinically relevant improvements in asthma control (ACQ score difference: −0.6; P=.03) and exhibited a nonsignificant trend of improvement in asthma-related quality of life (Pediatric Asthma Quality of Life Questionnaire score difference: −0.45; P=.15) when compared to those who did not adhere to education. Frequent monitoring alone did not improve asthma control (P=.07) and quality of life (P=.44) significantly, but its combination with education did result in improved ACQ scores (difference: −0.88; P=.02). There were no significant differences in outcomes between normoperceivers and hypoperceivers. Conclusions: Education, especially in combination with frequent web-based monitoring, is an important determinant for the 1-year outcomes of asthma control in internet-based self-management programs for adolescents with partly controlled and uncontrolled asthma; however, we could not establish the effect of symptom perception. This study provides important knowledge on the effects of asthma education and monitoring in daily life. %M 34879001 %R 10.2196/17959 %U https://pediatrics.jmir.org/2021/4/e17959 %U https://doi.org/10.2196/17959 %U http://www.ncbi.nlm.nih.gov/pubmed/34879001 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e25305 %T A Theory- and Evidence-Based Digital Intervention Tool for Weight Loss Maintenance (NoHoW Toolkit): Systematic Development and Refinement Study %A Marques,Marta M %A Matos,Marcela %A Mattila,Elina %A Encantado,Jorge %A Duarte,Cristiana %A Teixeira,Pedro J %A Stubbs,R James %A Sniehotta,Falko F %A Ermes,Miikka %A Harjumaa,Marja %A Leppänen,Juha %A Välkkynen,Pasi %A Silva,Marlene N %A Ferreira,Cláudia %A Carvalho,Sérgio %A Palmeira,Lara %A Horgan,Graham %A Heitmann,Berit Lilienthal %A Evans,Elizabeth H %A Palmeira,António L %+ Comprehensive Health Research Centre, NOVA Medical School, Universidade Nova de Lisboa, Rua do Instituto Bacteriológico, nº 5 l, Lisbon, 1150-190, Portugal, 351 218803105, mmarques@nms.unl.pt %K mHealth %K behavior change techniques %K weight management %K motivation %K self-regulation %K emotion regulation %K self-monitoring %K user testing %K logic models %D 2021 %7 3.12.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Many weight loss programs show short-term effectiveness, but subsequent weight loss maintenance is difficult to achieve. Digital technologies offer a promising means of delivering behavior change approaches at low costs and on a wide scale. The Navigating to a Healthy Weight (NoHoW) project, which was funded by the European Union’s Horizon 2020 research and innovation program, aimed to develop, test, and evaluate a digital toolkit designed to promote successful long-term weight management. The toolkit was tested in an 18-month, large-scale, international, 2×2 factorial (motivation and self-regulation vs emotion regulation) randomized controlled trial that was conducted on adults with overweight or obesity who lost ≥5% of their body weight in the preceding 12 months before enrollment into the intervention. Objective: This paper aims to describe the development of the NoHoW Toolkit, focusing on the logic models, content, and specifications, as well as the results from user testing. Methods: The toolkit was developed by using a systematic approach, which included the development of the theory-based logic models, the selection of behavior change techniques, the translation of these techniques into a web-based app (NoHoW Toolkit components), technical development, and the user evaluation and refinement of the toolkit. Results: The toolkit included a set of web-based tools and inputs from digital tracking devices (smart scales and activity trackers) and modules that targeted weight, physical activity, and dietary behaviors. The final toolkit comprised 34 sessions that were distributed through 15 modules and provided active content over a 4-month period. The motivation and self-regulation arm consisted of 8 modules (17 sessions), the emotion regulation arm was presented with 7 modules (17 sessions), and the combined arm received the full toolkit (15 modules; 34 sessions). The sessions included a range of implementations, such as videos, testimonies, and questionnaires. Furthermore, the toolkit contained 5 specific data tiles for monitoring weight, steps, healthy eating, mood, and sleep. Conclusions: A systematic approach to the development of digital solutions based on theory, evidence, and user testing may significantly contribute to the advancement of the science of behavior change and improve current solutions for sustained weight management. Testing the toolkit by using a 2×2 design provided a unique opportunity to examine the effect of motivation and self-regulation and emotion regulation separately, as well as the effect of their interaction in weight loss maintenance. %M 34870602 %R 10.2196/25305 %U https://www.jmir.org/2021/12/e25305 %U https://doi.org/10.2196/25305 %U http://www.ncbi.nlm.nih.gov/pubmed/34870602 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 12 %P e27956 %T Conversational Agent for Healthy Lifestyle Behavior Change: Web-Based Feasibility Study %A Dhinagaran,Dhakshenya Ardhithy %A Sathish,Thirunavukkarasu %A Soong,AiJia %A Theng,Yin-Leng %A Best,James %A Tudor Car,Lorainne %+ Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Clinical Sciences Building, 11 Mandalay Road, Singapore, 308232, Singapore, 65 69041258, lorainne.tudor.car@ntu.edu.sg %K chatbot %K conversational agents %K behavior change %K healthy lifestyle behavior change %K pilot study %K feasibility trial %K usability %K acceptability %K preliminary efficacy %K mobile phone %D 2021 %7 3.12.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: The rising incidence of chronic diseases is a growing concern, especially in Singapore, which is one of the high-income countries with the highest prevalence of diabetes. Interventions that promote healthy lifestyle behavior changes have been proven to be effective in reducing the progression of prediabetes to diabetes, but their in-person delivery may not be feasible on a large scale. Novel technologies such as conversational agents are a potential alternative for delivering behavioral interventions that promote healthy lifestyle behavior changes to the public. Objective: The aim of this study is to assess the feasibility and acceptability of using a conversational agent promoting healthy lifestyle behavior changes in the general population in Singapore. Methods: We performed a web-based, single-arm feasibility study. The participants were recruited through Facebook over 4 weeks. The Facebook Messenger conversational agent was used to deliver the intervention. The conversations focused on diet, exercise, sleep, and stress and aimed to promote healthy lifestyle behavior changes and improve the participants’ knowledge of diabetes. Messages were sent to the participants four times a week (once for each of the 4 topics of focus) for 4 weeks. We assessed the feasibility of recruitment, defined as at least 75% (150/200) of our target sample of 200 participants in 4 weeks, as well as retention, defined as 33% (66/200) of the recruited sample completing the study. We also assessed the participants’ satisfaction with, and usability of, the conversational agent. In addition, we performed baseline and follow-up assessments of quality of life, diabetes knowledge and risk perception, diet, exercise, sleep, and stress. Results: We recruited 37.5% (75/200) of the target sample size in 1 month. Of the 75 eligible participants, 60 (80%) provided digital informed consent and completed baseline assessments. Of these 60 participants, 56 (93%) followed the study through till completion. Retention was high at 93% (56/60), along with engagement, denoted by 50% (30/60) of the participants communicating with the conversational agent at each interaction. Acceptability, usability, and satisfaction were generally high. Preliminary efficacy of the intervention showed no definitive improvements in health-related behavior. Conclusions: The delivery of a conversational agent for healthy lifestyle behavior change through Facebook Messenger was feasible and acceptable. We were unable to recruit our planned sample solely using the free options in Facebook. However, participant retention and conversational agent engagement rates were high. Our findings provide important insights to inform the design of a future randomized controlled trial. %M 34870611 %R 10.2196/27956 %U https://formative.jmir.org/2021/12/e27956 %U https://doi.org/10.2196/27956 %U http://www.ncbi.nlm.nih.gov/pubmed/34870611 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e26987 %T Clinical Efficacy and Psychological Mechanisms of an App-Based Digital Therapeutic for Generalized Anxiety Disorder: Randomized Controlled Trial %A Roy,Alexandra %A Hoge,Elizabeth A %A Abrante,Pablo %A Druker,Susan %A Liu,Tao %A Brewer,Judson A %+ Department of Behavioral and Social Sciences, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02903, United States, 1 401 863 2826, judson_brewer@brown.edu %K anxiety %K generalized anxiety disorder %K worry %K mindfulness %K mHealth %K digital therapeutics %K mobile phone %D 2021 %7 2.12.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Current treatments for generalized anxiety disorder (GAD) often yield suboptimal outcomes, partly because of insufficient targeting of underlying psychological mechanisms (eg, avoidance reinforcement learning). Mindfulness training (MT) has shown efficacy for anxiety; yet, widespread adoption has been limited, partly because of the difficulty in scaling in-person–based delivery. Digital therapeutics are emerging as potentially viable treatments; however, very few have been empirically validated. Objective: The aim of this study is to test the efficacy and mechanism of an app-delivered MT that was designed to target a potential mechanism of anxiety (reinforcement learning), based on which previous studies have shown concern regarding feedback and the perpetuation of anxiety through negative reinforcement. Methods: Individuals with GAD were recruited using social media advertisements and randomized during an in-person visit to receive treatment as usual (n=33) or treatment as usual+app−delivered MT (Unwinding Anxiety; n=32). The latter was composed of 30 modules to be completed over a 2-month period. Associated changes in outcomes were assessed using self-report questionnaires 1 and 2 months after treatment initiation. Results: We randomized 65 participants in this study, and a modified intent-to-treat approach was used for analysis. The median number of modules completed by the MT group was 25.5 (IQR 17) out of 30; 46% (13/28) of the participants completed the program. In addition, the MT group demonstrated a significant reduction in anxiety (GAD-7) compared with the control group at 2 months (67% vs 14%; median change in GAD-7: –8.5 [IQR 6.5] vs –1.0 [IQR 5.0]; P<.001; 95% CI 6-10). Increases in mindfulness at 1 month (nonreactivity subscale) mediated decreases in worry at 2 months (Penn State Worry Questionnaire; P=.02) and decreases in worry at 1 month mediated reductions in anxiety at 2 months (P=.03). Conclusions: To our knowledge, this is the first report on the efficacy and mechanism of an app-delivered MT for GAD. These findings demonstrate the clinical efficacy of MT as a digital therapeutic for individuals with anxiety (number needed to treat=1.6). These results also link recent advances in our mechanistic understanding of anxiety with treatment development, showing that app-delivered MT targets key reinforcement learning pathways, resulting in tangible, clinically meaningful reductions in worry and anxiety. Evidence-based, mechanistically targeted digital therapeutics have the potential to improve health at a population level at a low cost. Trial Registration: ClinicalTrials.gov NCT03683472; https://clinicaltrials.gov/ct2/show/NCT03683472 %M 34860673 %R 10.2196/26987 %U https://www.jmir.org/2021/12/e26987 %U https://doi.org/10.2196/26987 %U http://www.ncbi.nlm.nih.gov/pubmed/34860673 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e30855 %T Frequency of Online Health Information Seeking and Types of Information Sought Among the General Chinese Population: Cross-sectional Study %A Xiong,Zihui %A Zhang,Liang %A Li,Zhong %A Xu,Wanchun %A Zhang,Yan %A Ye,Ting %+ School of Medicine and Health Management, Tongji Medical College, Huazhong University of Science and Technology, No 13 Hangkong Rd, Qiaokou District, Wuhan, 430030, China, 86 134 7621 5639, yeting@hust.edu.cn %K online health information seeking %K sociodemographic factors %K information types %K Chinese population %K information seeking behavior %K demography %K China %K online health information %D 2021 %7 2.12.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The internet is one of the most popular health information resources, and the Chinese constitute one-fifth of the online users worldwide. As internet penetration continues to rise, more details on the Chinese population seeking online health information need to be known based on the current literature. Objective: This study aims to explore the sociodemographic differences in online health information seeking (OHIS), including the frequency of OHIS and the types of online health information sought among the general Chinese population in mainland China. Methods: A cross-sectional study for assessing the residents’ health care needs with self-administered questionnaires was implemented in 4 counties and districts in China from July 2018 to August 2018. Pearson’s chi-square test was used to identify the sociodemographic differences between infrequent and frequent online health information seekers. We also performed binary logistic regression for the 4 types of online health information as the dependent variables and the sociodemographic factors as the independent variables. Results: Compared with infrequent online health information seekers, frequent seekers were more likely to be female (infrequent: 1654/3318; 49.85%; frequent: 1015/1831, 55.43%), older (over 60 years old; infrequent: 454/3318, 13.68%; frequent: 282/1831, 15.40%), married (infrequent: 2649/3318, 79.84%; frequent: 1537/1831, 83.94%), and better educated (bachelor’s or above; infrequent: 834/3318, 25.14%; frequent: 566/1831, 30.91%). They were also more likely to earn a higher income (over RMB ¥50k [RMB ¥1=US $0.15641]; infrequent: 1139/3318, 34.33%; frequent: 710/1831, 34.78%), have commercial health insurance (infrequent: 628/3318, 18.93%; frequent: 470/1831, 25.67%), and have reported illness in the past 12 months (infrequent: 659/3318, 19.86%; frequent: 415/1831, 22.67%). Among the 4 health information types, health science popularization was the most searched for information by Chinese online health information seekers (3654/5149, 70.79%), followed by healthy behaviors (3567/5149, 69.28%), traditional Chinese medicine (1931/5149, 37.50%), and medical concerns (1703/5149, 33.07%). The binary logistic regression models showed that males were less likely to seek information on healthy behaviors (adjusted odds ratio [AOR] 0.69, 95% CI 0.61-0.78) and traditional Chinese medicine (AOR 0.64, 95% CI 0.57-0.73), and respondents who had at least 1 chronic disease were more likely to seek information on medical concerns (AOR 1.27, 95% CI 1.07-1.51) and traditional Chinese medicine (AOR 1.26, 95% CI 1.06-1.49). Conclusions: Sociodemographic factors were associated with the frequency of OHIS and types of information sought among the general Chinese population. The results remind providers of online health information to consider the needs of specific population groups when tailoring and presenting health information to the target population. %M 34860676 %R 10.2196/30855 %U https://www.jmir.org/2021/12/e30855 %U https://doi.org/10.2196/30855 %U http://www.ncbi.nlm.nih.gov/pubmed/34860676 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 8 %N 4 %P e31213 %T Effect of a Mobile Health App on Adherence to Physical Health Treatment: Retrospective Analysis %A Greenstein,Jay %A Topp,Robert %A Etnoyer-Slaski,Jena %A Staelgraeve,Michael %A McNulty,John %+ Kaizenovate, Kaizo Clinical Research Institute, Kaizo Health, 827E Rockville Pike, Rockville, MD, 20852, United States, 1 301 251 2777, drjay@kaizo-health.com %K adherence %K self-discharge %K phone app %K physical therapy %K chiropractor %K mobile phone %D 2021 %7 2.12.2021 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: Adherence to prescribed medical interventions can predict the efficacy of the treatment. In physical health clinics, not adhering to prescribed therapy can take the form of not attending a scheduled clinic visit (no-show appointment) or prematurely terminating treatment against the advice of the provider (self-discharge). A variety of interventions, including mobile phone apps, have been introduced for patients to increase their adherence to attending scheduled clinic visits. Limited research has examined the impact of a mobile phone app among patients attending chiropractic and rehabilitation clinic visits. Objective: This study aims to compare adherence to prescribed physical health treatment among patients attending a chiropractic and rehabilitation clinic who did and did not choose to adopt a phone-based app to complement their treatment. Methods: The medical records of new patients who presented for care during 2019 and 2020 at 5 community-based chiropractic and rehabilitation clinics were reviewed for the number of kept and no-show appointments and to determine whether the patient was provider-discharged or self-discharged. During this 24-month study, 36.28% (1497/4126) of patients seen in the targeted clinics had downloaded the Kanvas app on their mobile phone, whereas the remaining patients chose not to download the app (usual care group). The gamification component of the Kanvas app provided the patient with a point every time they attended their visits, which could be redeemed as an incentive. Results: During both 2019 and 2020, the Kanvas app group was provider-discharged at a greater rate than the usual care group. The Kanvas app group kept a similar number of appointments compared with the usual care group in 2019 but kept significantly more appointments than the usual care group in 2020. During 2019, both groups exhibited a similar number of no-show appointments; however, in 2020, the Kanvas app group demonstrated more no-show appointments than the usual care group. When collapsed across years and self-discharged, the Kanvas app group had a greater number of kept appointments compared with the usual care group. When provider-discharged, both groups exhibited a similar number of kept appointments. The Kanvas app group and the usual care group were similar in the number of no-show appointments when provider-discharged, and when self-discharged, the Kanvas app group had more no-show appointments compared with the usual care group. Conclusions: Patients who did or did not have access to the Kanvas app and were provider-discharged exhibited a similar number of kept appointments and no-show appointments. When patients were self-discharged and received the Kanvas app, they exhibited 3.2 more kept appointments and 0.94 more no-show appointments than the self-discharged usual care group. %M 34655468 %R 10.2196/31213 %U https://rehab.jmir.org/2021/4/e31213 %U https://doi.org/10.2196/31213 %U http://www.ncbi.nlm.nih.gov/pubmed/34655468 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 12 %P e24840 %T Development of a Web-Based School Support System Within the AVATAR Project for Psychosocial Well-being in Adolescents: Pilot Feasibility Study %A Mastorci,Francesca %A Piaggi,Paolo %A Trivellini,Gabriele %A Doveri,Cristina %A Casu,Anselmo %A Bastiani,Luca %A Marinaro,Irene %A Vassalle,Cristina %A Pingitore,Alessandro %+ Clinical Physiology Institute, Consiglio Nazionale delle Ricerche Area della Ricerca di Pisa (CNR), Via Moruzzi 1, Pisa, 56124, Italy, 39 050312605, pingi@ifc.cnr.it %K adolescent %K well-being management %K schools %K web tool %K health promotion %D 2021 %7 2.12.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Health and well-being promotions are key points of educational programs for adolescents within schools. There are several health education programs mainly based on lifestyle habit changes; however, social and emotional dimensions should be considered within these educational strategies. Objective: This study aimed to (1) develop a new web-based school support system to assess and analyze individual, classroom, and scholastic institute data on lifestyle habits, social context, emotional status, and scholastic performance; (2) create a web tool for managing the well-being of adolescents through a dynamic and personalized interface that provides immediate feedback that allows the school to monitor progress; and (3) evaluate, in a pilot study, the feasibility of this web-based school support system in order to build health programs that are specific to the needs of the studied population. Methods: The AVATAR (a new purpose for the promotion and evaluation of health and well-being among healthy teenagers) method consists of integrating the information coming from different questionnaires. In particular, to allow planning didactic and educational actions based on the results obtained, the AVATAR approach allows subdivision of the results of the different observed variables and the 4 components into the following 3 percentile categories: modify, improve, and maintain. The AVATAR web platform was designed to collect data on lifestyle, emotional status, and social context from junior high schools in terms of the fundamental aspects of adolescent daily life, with free use by the scholastic community (scholars, teachers, and parents). In this pilot/feasibility study, data from 331 students were acquired between 2018 and 2019 at the beginning of the scholastic year (pre) and at the end following the school-based program (post). Results: Preliminary results showed that after school planning and specific program implementation, defined after AVATAR feedback, students reported better well-being perception characterized by higher perception in psychological well-being (P=.001), mood (P=.001), self-perception (P=.006), and autonomy (P=.001), and an increase in the perception of financial resources (P=.001), which helped in developing healthy lifestyle habits (P=.007). In the social context assessment, students reported stronger relationships with family (P=.02) and peers (P=.001), and a lower perception of bullying (P=.001). Conclusions: The AVATAR web-based platform is a feasible and flexible tool for the health and well-being management of adolescents from epidemiological, preventive, and educational points of view. In particular, it can be used to (1) promote information campaigns aimed at modifying risk behaviors in the student population, (2) sensitize students and put them at the center of their growth path, (3) inform institutions about the health and well-being of the school population, (4) ensure health programs are acceptable and feasible to users before launching on a large scale, and (5) improve the relationship of users (school) and educational agencies with research groups. %M 34860668 %R 10.2196/24840 %U https://formative.jmir.org/2021/12/e24840 %U https://doi.org/10.2196/24840 %U http://www.ncbi.nlm.nih.gov/pubmed/34860668 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 12 %P e22390 %T Use and Appreciation of a Web-Based, Computer-Tailored Diet and Physical Activity Intervention Based on the Self-determination Theory: Evaluation Study of Process and Predictors %A Coumans,Juul M J %A Oenema,Anke %A Bolman,Catherine A W %A Lechner,Lilian %+ Department of Health Psychology, Faculty of Psychology, Open University of the Netherlands, Valkenburgerweg 177, Heerlen, 6419 AT, Netherlands, 31 45 576 2635, juul.coumans@ou.nl %K diet %K physical activity %K eHealth %K self-determination theory %K motivational interviewing %K process evaluation %K nonusage attrition %D 2021 %7 2.12.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: eHealth is a promising tool for promoting lifestyle behaviors such as a healthy diet and physical activity (PA). However, making people use interventions is a crucial and challenging problem in eHealth. More insight into use patterns and predicting factors is needed to improve future interventions. Objective: This study aims to examine the use, predictors of use, and appreciation of a web-based, computer-tailored, dietary and PA promotion intervention, MyLifestyleCoach, which is based on the self-determination theory. First, we depict the participants’ flow in the intervention and identify moments when they are likely to discontinue use. Second, we investigate whether demographic, motivational, and program-related characteristics predict the use of several intervention elements. Finally, we report the appreciation scores for the intervention and the participant and program characteristics associated with these scores. Methods: This study was based on data from web-based self-report questionnaires. Here, objectively assessed intervention use data were analyzed from participants randomized to the intervention condition. Multiple stepwise (logistic) regression analyses were conducted to examine the predictors of intervention use and evaluation scores. Results: Our findings indicate a low full completion rate for the intervention among those who chose and completed the diet module (49/146, 33.6%), the PA module (2/12, 17%), and both modules (58/273, 21.2%). Several points in the intervention where participants were likely to stop using the intervention were identified. Autonomous and intrinsic motivation toward diet were related to the completion of the initial sessions of the intervention (ie, the opening session in which participants could choose which module to follow and the first session of the diet module). In contrast, controlled motivation was linked to the completion of both modules (initial and follow-up sessions). Appreciation scores were somewhat positive. Appreciation was predicted by several motivational constructs, such as amotivation and basic psychological needs (eg, competence) and program-related features (eg, number of completed sessions). Conclusions: This study adds meaningful information on the use and appreciation of a web-based, computer-tailored dietary and PA intervention, MyLifestyleCoach. The results indicate that different types of motivations, such as extrinsic and intrinsic motivation, are at play at the points when people are likely to stop using the intervention. The intervention was appreciated fairly well, and several motivational constructs and fulfillment of basic psychological needs were associated with appreciation. Practical implications of these findings have been provided in this study. %M 34860670 %R 10.2196/22390 %U https://formative.jmir.org/2021/12/e22390 %U https://doi.org/10.2196/22390 %U http://www.ncbi.nlm.nih.gov/pubmed/34860670 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 5 %N 2 %P e31985 %T Toward the Value Sensitive Design of eHealth Technologies to Support Self-management of Cardiovascular Diseases: Content Analysis %A Cruz-Martínez,Roberto Rafael %A Wentzel,Jobke %A Bente,Britt Elise %A Sanderman,Robbert %A van Gemert-Pijnen,Julia EWC %+ Department of Psychology, Health and Technology, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Cubicus Bldg, 10, De Zul, Enschede, 7522 NJ, Netherlands, 31 683186149, r.cruzmartinez@utwente.nl %K eHealth %K self-management %K self-care %K cardiovascular diseases %K value sensitive design %K values %K content analysis %D 2021 %7 1.12.2021 %9 Original Paper %J JMIR Cardio %G English %X Background: eHealth can revolutionize the way self-management support is offered to chronically ill individuals such as those with a cardiovascular disease (CVD). However, patients’ fluctuating motivation to actually perform self-management is an important factor for which to account. Tailoring and personalizing eHealth to fit with the values of individuals promises to be an effective motivational strategy. Nevertheless, how specific eHealth technologies and design features could potentially contribute to values of individuals with a CVD has not been explicitly studied before. Objective: This study sought to connect a set of empirically validated, health-related values of individuals with a CVD with existing eHealth technologies and their design features. The study searched for potential connections between design features and values with the goal to advance knowledge about how eHealth technologies can actually be more meaningful and motivating for end users. Methods: Undertaking a technical investigation that fits with the value sensitive design framework, a content analysis of existing eHealth technologies was conducted. We matched 11 empirically validated values of CVD patients with 70 design features from 10 eHealth technologies that were previously identified in a systematic review. The analysis consisted mainly of a deductive coding stage performed independently by 3 members of the study team. In addition, researchers and developers of 6 of the 10 reviewed technologies provided input about potential feature-value connections. Results: In total, 98 connections were made between eHealth design features and patient values. This meant that some design features could contribute to multiple values. Importantly, some values were more often addressed than others. CVD patients’ values most often addressed were related to (1) having or maintaining a healthy lifestyle, (2) having an overview of personal health data, (3) having reliable information and advice, (4) having extrinsic motivators to accomplish goals or health-related activities, and (5) receiving personalized care. In contrast, values less often addressed concerned (6) perceiving low thresholds to access health care, (7) receiving social support, (8) preserving a sense of autonomy over life, and (9) not feeling fear, anxiety, or insecurity about health. Last, 2 largely unaddressed values were related to (10) having confidence and self-efficacy in the treatment or ability to achieve goals and (11) desiring to be seen as a person rather than a patient. Conclusions: Positively, existing eHealth technologies could be connected with CVD patients’ values, largely through design features that relate to educational support, self-monitoring support, behavior change support, feedback, and motivational incentives. Other design features such as reminders, prompts or cues, peer-based or expert-based human support, and general system personalization were also connected with values but in narrower ways. In future studies, the inferred feature-value connections must be validated with empirical data from individuals with a CVD or similar chronic conditions. %M 34855608 %R 10.2196/31985 %U https://cardio.jmir.org/2021/2/e31985 %U https://doi.org/10.2196/31985 %U http://www.ncbi.nlm.nih.gov/pubmed/34855608 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e31734 %T Long-term Effectiveness of a Multistrategy Behavioral Intervention to Increase the Nutritional Quality of Primary School Students’ Online Lunch Orders: 18-Month Follow-up of the Click & Crunch Cluster Randomized Controlled Trial %A Wyse,Rebecca %A Delaney,Tessa %A Stacey,Fiona %A Lecathelinais,Christophe %A Ball,Kylie %A Zoetemeyer,Rachel %A Lamont,Hannah %A Sutherland,Rachel %A Nathan,Nicole %A Wiggers,John H %A Wolfenden,Luke %+ Hunter New England Population Health, Locked Bag 10, Wallsend, 2287, Australia, 61 2 404 20272, r.wyse@newcastle.edu.au %K child diet %K consumer behavior %K intervention %K RCT %K public health nutrition %K obesity %K school %K school canteen %K long-term follow-up %K choice architecture %K public health %K nutrition %K children %K diet %K eHealth %K school lunch %D 2021 %7 29.11.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: School food services, including cafeterias and canteens, are an ideal setting in which to improve child nutrition. Online canteen ordering systems are increasingly common and provide unique opportunities to deliver choice architecture strategies to nudge users to select healthier items. Despite evidence of short-term effectiveness, there is little evidence regarding the long-term effectiveness of choice architecture interventions, particularly those delivered online. Objective: This study determined the long-term effectiveness of a multistrategy behavioral intervention (Click & Crunch) embedded within an existing online school lunch-ordering system on the energy, saturated fat, sugar, and sodium content of primary school students’ lunch orders 18 months after baseline. Methods: This cluster randomized controlled trial (RCT) involved a cohort of 2207 students (aged 5-12 years) from 17 schools in New South Wales, Australia. Schools were randomized to receive either a multistrategy behavioral intervention or the control (usual online ordering only). The intervention strategies ran continuously for 14-16.5 months until the end of follow-up data collection. Trial primary outcomes (ie, mean total energy, saturated fat, sugar and sodium content of student online lunch orders) and secondary outcomes (ie, the proportion of online lunch order items that were categorized as everyday, occasional, and caution) were assessed over an 8-week period at baseline and 18-month follow-up. Results: In all, 16 schools (94%) participated in the 18-month follow-up. Over time, from baseline to follow-up, relative to control orders, intervention orders had significantly lower energy (–74.1 kJ; 95% CI [–124.7, –23.4]; P=.006) and saturated fat (–0.4 g; 95% CI [–0.7, –0.1]; P=.003) but no significant differences in sugar or sodium content. Relative to control schools, the odds of purchasing everyday items increased significantly (odds ratio [OR] 1.2; 95% CI [1.1, 1.4]; P=.009, corresponding to a +3.8% change) and the odds of purchasing caution items significantly decreased among intervention schools (OR 0.7, 95% CI [0.6, 0.9]; P=.002, corresponding to a –2.6% change). There was no between-group difference over time in canteen revenue. Conclusions: This is the first study to investigate the sustained effect of a choice architecture intervention delivered via an online canteen ordering systems in schools. The findings suggest that there are intervention effects up to 18-months postbaseline in terms of decreased energy and saturated fat content and changes in the relative proportions of healthy and unhealthy food purchased for student lunches. As such, this intervention approach may hold promise as a population health behavior change strategy within schools and may have implications for the use of online food-ordering systems more generally; however, more research is required. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618000855224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375075 %M 34847063 %R 10.2196/31734 %U https://www.jmir.org/2021/11/e31734 %U https://doi.org/10.2196/31734 %U http://www.ncbi.nlm.nih.gov/pubmed/34847063 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e27639 %T Effectiveness of a Mobile Device–Based Resilience Training Program in Reducing Depressive Symptoms and Enhancing Resilience and Quality of Life in Parents of Children With Cancer: Randomized Controlled Trial %A Luo,Yuanhui %A Xia,Wei %A Cheung,Ankie Tan %A Ho,Laurie Long Kwan %A Zhang,Jingping %A Xie,Jianhui %A Xiao,Pin %A Li,Ho Cheung William %+ Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, New Territories, Room 831, Esther Lee Building, Hong Kong, China, 86 39430889, williamli@cuhk.edu.hk %K depressive symptoms %K pediatric cancer %K parents %K quality of life %K resilience %K mobile phone %D 2021 %7 29.11.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Caring for children with cancer can be a stressful experience for parents and may have negative effects on their physical and psychological well-being. Although evidence has shown that resilience is associated with positive psychological well-being, few interventions have been specifically designed to enhance the resilience of parents of children with cancer. Objective: The aim of this study is to examine the effectiveness of a mobile device–based resilience training program in reducing depressive symptoms and enhancing resilience and quality of life (QoL) in parents of children with cancer. Methods: Parents of children diagnosed with cancer were recruited from the pediatric oncology wards of 3 tertiary hospitals in China. The participants were randomly assigned to either the experimental group (52/103, 50.5%) to undergo an 8-week mobile device–based resilience training program or to the control group (51/103, 49.5%) to receive an 8-week program of placebo information. The study outcomes included resilience, depressive symptoms, and QoL, as measured by the Connor–Davidson Resilience Scale, the Self-Rating Depression Scale, and the Short Form of the 6-Dimension Health Survey, respectively. All data were collected at baseline and at 2 and 6 months of follow-up. The data analysis followed the intention-to-treat principle. A generalized estimating equation was used to examine the effects of the intervention. Results: The participants were mostly female (72/103, 69.9%), and their mean age was 33.6 (SD 5.2) years. The participants in the experimental group showed significantly higher levels of resilience (mean 67.96, SD 15.8 vs mean 58.27, SD 19.0; P<.001) and lower levels of depressive symptoms (mean 40.17, SD 9.9 vs mean 46.04, SD 10.9; P<.001) than those in the control group at 6 months of follow-up. The intervention showed statistically significant effects in improving resilience (β=6.082; P=.01) and decreasing depressive symptoms (β=−2.772; P=.04) relative to the control group. The QoL score in the experimental group was higher than that in the control group at 6 months of follow-up (mean 0.79, SD 0.2 vs mean 0.76, SD 0.3; P=.07); however, no statistically significant intervention effect was detected (β=.020; P=.38). Conclusions: The mobile device–based resilience training program effectively enhanced resilience and alleviated depressive symptoms in parents of children with cancer. It is highly recommended that health care professionals incorporate this resilience training program when providing psychological care to parents of children with cancer. Trial Registration: Clinical.Trials.gov NCT04038242; http://clinicaltrials.gov/ct2/show/NCT04038242 %M 34847060 %R 10.2196/27639 %U https://www.jmir.org/2021/11/e27639 %U https://doi.org/10.2196/27639 %U http://www.ncbi.nlm.nih.gov/pubmed/34847060 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 11 %P e32199 %T Examining the Effectiveness of Gamification in Mental Health Apps for Depression: Systematic Review and Meta-analysis %A Six,Stephanie G %A Byrne,Kaileigh A %A Tibbett,Thomas P %A Pericot-Valverde,Irene %+ Department of Psychology, Clemson University, 418 Brackett Hall, Clemson, SC, 29634, United States, 1 864 656 3935, kaileib@clemson.edu %K depression %K reward %K gamification %K mental health apps %K apps %D 2021 %7 29.11.2021 %9 Review %J JMIR Ment Health %G English %X Background: Previous research showed that computerized cognitive behavioral therapy can effectively reduce depressive symptoms. Some mental health apps incorporate gamification into their app design, yet it is unclear whether features differ in their effectiveness to reduce depressive symptoms over and above mental health apps without gamification. Objective: The aim of this study was to determine whether mental health apps with gamification elements differ in their effectiveness to reduce depressive symptoms when compared to those that lack these elements. Methods: A meta-analysis of studies that examined the effect of app-based therapy, including cognitive behavioral therapy, acceptance and commitment therapy, and mindfulness, on depressive symptoms was performed. A total of 5597 articles were identified via five databases. After screening, 38 studies (n=8110 participants) remained for data extraction. From these studies, 50 total comparisons between postintervention mental health app intervention groups and control groups were included in the meta-analysis. Results: A random effects model was performed to examine the effect of mental health apps on depressive symptoms compared to controls. The number of gamification elements within the apps was included as a moderator. Results indicated a small to moderate effect size across all mental health apps in which the mental health app intervention effectively reduced depressive symptoms compared to controls (Hedges g=–0.27, 95% CI –0.36 to –0.17; P<.001). The gamification moderator was not a significant predictor of depressive symptoms (β=–0.03, SE=0.03; P=.38), demonstrating no significant difference in effectiveness between mental health apps with and without gamification features. A separate meta-regression also did not show an effect of gamification elements on intervention adherence (β=–1.93, SE=2.28; P=.40). Conclusions: The results show that both mental health apps with and without gamification elements were effective in reducing depressive symptoms. There was no significant difference in the effectiveness of mental health apps with gamification elements on depressive symptoms or adherence. This research has important clinical implications for understanding how gamification elements influence the effectiveness of mental health apps on depressive symptoms. %M 34847058 %R 10.2196/32199 %U https://mental.jmir.org/2021/11/e32199 %U https://doi.org/10.2196/32199 %U http://www.ncbi.nlm.nih.gov/pubmed/34847058 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 11 %P e29712 %T Association of Innate and Acquired Aerobic Capacity With Resilience in Healthy Adults: Protocol for a Randomized Controlled Trial of an 8-Week Web-Based Physical Exercise Intervention %A Ochmann,David T %A Philippi,Keito F A %A Zeier,Peter %A Sandner,Magdalena %A Hillen,Barlo %A Neuberger,Elmo W I %A Ruiz de Azua,Inigo %A Lieb,Klaus %A Wessa,Michèle %A Lutz,Beat %A Simon,Perikles %A Brahmer,Alexandra %+ Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg-University Mainz, Albert-Schweitzer-Str. 22, Mainz, 55128, Germany, 49 61313937283, albrahme@uni-mainz.de %K stress resilience %K eHealth %K aerobic capacity %K peak oxygen uptake %K cortisol %K kynurenic acid %K endocannabinoids %D 2021 %7 29.11.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Physical activity alleviates chronic stress. The latest research suggests a relationship between resilience and physical fitness. Beneficial adaptations of the hypothalamic-pituitary-adrenal axis, sympathetic nervous system, endocannabinoid system, and tryptophan pathway, which are induced by an active lifestyle, are considered to be conducive to resilience. However, detailed knowledge on the molecular link between the effects of acute and chronic physical exercise and improved resilience to stress in humans is missing. Moreover, the relationship between innate and acquired aerobic capacity and resilience is poorly understood. Objective: The aim of this study is to implement a human exercise intervention trial addressing the following main hypotheses: a high innate aerobic capacity is associated with high resilience to stress, and web-based physical exercise training improves aerobic capacity of physically inactive adults, which is accompanied by improved resilience. In this setting, we will analyze the relationship between resilience parameters and innate and acquired aerobic capacity as well as circulating signaling molecules. Methods: A total of 70 healthy, physically inactive (<150 minutes/week of physical activity) adults (aged 18-45 years) will be randomly assigned to an intervention or control group. Participants in the intervention group will receive weekly training using progressive endurance and interval running adapted individually to their remotely supervised home training performance via web-based coach support. A standardized incremental treadmill exercise test will be performed before and after the intervention period of 8 weeks to determine the innate and acquired aerobic capacity (peak oxygen uptake). Before and after the intervention, psychological tests and questionnaires that characterize parameters implicated in resilience will be applied. Blood and saliva will be sampled for the analysis of cortisol, lactate, endocannabinoids, catecholamines, kynurenic acid, and further circulating signal transducers. Statistical analysis will provide comprehensive knowledge on the relationship between aerobic capacity and resilience, as well as the capacity of peripheral factors to mediate the promoting effects of exercise on resilience. Results: The study was registered in October 2019, and enrollment began in September 2019. Of the 161 participants who were initially screened via a telephone survey, 43 (26.7%) fulfilled the inclusion criteria and were included in the study. Among the 55% (17/31) of participants in the intervention group and 45% (14/31) of participants in the control group who completed the study, no serious adverse incidents were reported. Of 43 participants, 4 (9%) withdrew during the program (for individual reasons) and 8 (19%) have not yet participated in the program; moreover, further study recruitment was paused for an indeterminate amount of time because of the COVID-19 pandemic. Conclusions: Our study aims to further define the physiological characteristics of human resilience, and it may offer novel approaches for the prevention and therapy of mental disorders via an exercise prescription. International Registered Report Identifier (IRRID): DERR1-10.2196/29712 %M 34847062 %R 10.2196/29712 %U https://www.researchprotocols.org/2021/11/e29712 %U https://doi.org/10.2196/29712 %U http://www.ncbi.nlm.nih.gov/pubmed/34847062 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e23659 %T The Baby Steps Web Program for the Well-Being of New Parents: Randomized Controlled Trial %A Kavanagh,David John %A Connolly,Jennifer %A Fisher,Jane %A Halford,W Kim %A Hamilton,Kyra %A Hides,Leanne %A Milgrom,Jeannette %A Rowe,Heather %A Scuffham,Paul A %A White,Katherine M %A Wittkowski,Anja %A Appleton,Shelley %A Sanders,Davina %+ Centre for Children’s Health Research, Queensland University of Technology, 62 Raymond Terrace, South Brisbane Qld, 4101, Australia, 61 419 479227, david.kavanagh@qut.edu.au %K perinatal %K depression %K prevention %K men %K self-guided %K internet %D 2021 %7 26.11.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: New parents face increased risks of emotional distress and relationship dissatisfaction. Digital interventions increase support access, but few preventive programs are optimized for both parents. Objective: This study aims to conduct the first randomized controlled trial on universal self-guided digital programs to support positive perinatal adjustment of both mothers and fathers. Effects of childcare information (Baby Care) and information plus an interactive program (Baby Steps Wellbeing) were compared from the third trimester baseline to 3 and 6 months subsequently. Methods: The study recruited 388 co-parenting male-female adult couples expecting their first single child (26-38 weeks’ gestation), using web-based registration. Most (337/388, 86.8%) were obtained from prenatal hospital classes. Couples’ randomization was automated and stratified by Edinburgh Postnatal Depression Scale (EPDS) scores (50% couples scored high if either mother >7, father >5). All assessments were web-based self-reports: the EPDS and psychosocial quality of life were primary outcomes; relationship satisfaction, social support, and self-efficacy for parenting and support provision were secondary. Linear mixed models provided intention-to-treat analyses, with linear and quadratic effects for time and random intercepts for participants and couples. Results: Selection criteria were met by 63.9% (248/388) of couples, who were all randomized. Most participants were married (400/496, 80.6%), tertiary educated (324/496, 65.3%), employed full time (407/496, 82%), and born in Australia (337/496, 67.9%). Their mean age was 32.2 years, and average gestation was 30.8 weeks. Using an EPDS cutoff score of 13, 6.9% (18/248) of men, and 16.1% (40/248) of women screened positive for depression at some time during the 6 months. Retention of both partners was 80.6% (201/248) at the 6-month assessments, and satisfaction with both programs was strong (92% ≥50). Only 37.3% (185/496) of participants accessed their program more than once, with higher rates for mothers (133/248, 53.6%) than fathers (52/248, 20.9%; P<.001). The EPDS, quality of life, and social support did not show differential improvements between programs, but Baby Steps Wellbeing gave a greater linear increase in self-efficacy for support provision (P=.01; Cohen d=0.26) and lower reduction in relationship satisfaction (P=.03; Cohen d=0.20) than Baby Care alone. Mothers had greater linear benefits in parenting self-efficacy over time than fathers after receiving Baby Steps Wellbeing rather than Baby Care (P=.01; Cohen d=0.51). However, the inclusion of program type in analyses on parenting self-efficacy and relationship satisfaction did not improve model fit above analyses with only parent gender and time. Conclusions: Three secondary outcomes showed differential benefits from Baby Steps Wellbeing, but for one (parenting self-efficacy), the effect only occurred for mothers, perhaps reflecting their greater program use. Increased engagement will be needed for more definitive testing of the potential benefits of Baby StepsWellbeing for perinatal adjustment. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12614001256662; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367277 %M 34842534 %R 10.2196/23659 %U https://www.jmir.org/2021/11/e23659 %U https://doi.org/10.2196/23659 %U http://www.ncbi.nlm.nih.gov/pubmed/34842534 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e29742 %T Mechanisms of Change in Digital Health Interventions for Mental Disorders in Youth: Systematic Review %A Domhardt,Matthias %A Engler,Sophie %A Nowak,Hannah %A Lutsch,Arne %A Baumel,Amit %A Baumeister,Harald %+ Department of Clinical Psychology and Psychotherapy, Ulm University, Lise-Meitner-Str. 16, Ulm, D-89081, Germany, 49 73150 32803, matthias.domhardt@uni-ulm.de %K children and adolescents %K mental disorders %K mediator %K mechanisms of change %K digital health intervention %K psychotherapy %K mobile phone %D 2021 %7 26.11.2021 %9 Review %J J Med Internet Res %G English %X Background: Digital health interventions (DHIs) are efficacious for several mental disorders in youth; however, integrated, evidence-based knowledge about the mechanisms of change in these interventions is lacking. Objective: This systematic review aims to comprehensively evaluate studies on mediators and mechanisms of change in different DHIs for common mental disorders in children and adolescents. Methods: A systematic literature search of the electronic databases Cochrane Central Register of Controlled Trials, Embase, MEDLINE, and PsycINFO was conducted, complemented by backward and forward searches. Two independent reviewers selected studies for inclusion, extracted the data, and rated the methodological quality of eligible studies (ie, risk of bias and 8 quality criteria for process research). Results: A total of 25 studies that have evaluated 39 potential mediators were included in this review. Cognitive mediators were the largest group of examined intervening variables, followed by a broad range of emotional and affective, interpersonal, parenting behavior, and other mediators. The mediator categories with the highest percentages of significant intervening variables were the groups of affective mediators (4/4, 100%) and combined cognitive mediators (13/19, 68%). Although more than three-quarters of the eligible studies met 5 or more quality criteria, causal conclusions have been widely precluded. Conclusions: The findings of this review might guide the empirically informed advancement of DHIs, contributing to improved intervention outcomes, and the discussion of methodological recommendations for process research might facilitate mediation studies with more pertinent designs, allowing for conclusions with higher causal certainty in the future. %M 34842543 %R 10.2196/29742 %U https://www.jmir.org/2021/11/e29742 %U https://doi.org/10.2196/29742 %U http://www.ncbi.nlm.nih.gov/pubmed/34842543 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 4 %N 4 %P e28652 %T An App-Based Mindfulness-Based Self-compassion Program to Support Caregivers of People With Dementia: Participatory Feasibility Study %A Goodridge,Donna %A Reis,Nathan %A Neiser,Jenna %A Haubrich,Tim %A Westberg,Bev %A Erickson-Lumb,Laura %A Storozinski,Jo %A Gonzales,Cesar %A Michael,Joanne %A Cammer,Allison %A Osgood,Nathaniel %+ Department of Medicine, University of Saskatchewan, Room E1216, Health Sciences Building, 107 Wiggins Road, Saskatoon, SK, S7N 2Z4, Canada, 1 3069664209, donna.goodridge@usask.ca %K virtual support programs %K caregivers %K dementia %K mindfulness %K self-compassion %K mobile health %K mobile applications %K elderly %K older adults %K usability %K feasibility %K smartphone app %K mobile phone %D 2021 %7 26.11.2021 %9 Original Paper %J JMIR Aging %G English %X Background: The number of persons with dementia is steadily growing, as is the number of individuals supporting persons with dementia. Primary caregivers of persons with dementia are most often family members or spouses of the persons with dementia, and they are more likely to experience increased stress and other negative effects than individuals who are not primary caregivers. Although in-person support groups have been shown to help buffer the negative impacts of caregiving, some caregivers live in isolated or rural communities and are unable to make the burdensome commitment of traveling to cities. Using an interdisciplinary approach, we developed a mobile smartphone support app designed for primary caregivers of persons with dementia, with the goal of reducing caregiver burden and easing stress. The app features a 12-week intervention, largely rooted in mindfulness-based self-compassion (MBSC), because MBSC has been linked to minimizing stress, depression, and anxiety. Objective: The primary objectives of our program are twofold: to explore the feasibility of a 12-week mobile support program and to conduct an initial efficacy evaluation of changes in perceived caregiver burden, coping styles, and emotional well-being of caregivers before and after the program. Methods: Our feasibility study used a 2-phase participatory pretest and posttest design, focusing on acceptability, demand, practicality, implementation, and efficacy. At phase I, we recruited 57 primary caregivers of persons with dementia (mean age 76.3, SD 12.9 years), comprising spouses (21/57, 37%), children (21/57, 37%), and friends or relatives (15/57, 26%) of persons with dementia, of whom 29 (51%) completed all measures at both pre- and postprogram. The content of the program featured a series of MBSC podcasts. Our primary outcome measure was caregiver burden, with secondary outcome measures including coping styles and emotional well-being. Daily ecological momentary assessments enabled us to ask participants, “How are you feeling today?” Phase II of our study involved semistructured follow-up interviews with most participants (n=21) who completed phase I. Results: Our findings suggest that our app or program meets the feasibility criteria examined. Notably, participants generally accepted the program and believed it could be a useful resource. Emotional well-being increased significantly (P=.04), and emotion-based coping significantly decreased (P=.01). Participants generally considered the app or program to be a helpful resource. Conclusions: Although there were no significant changes in caregiver burden, we were encouraged by the increased emotional well-being of our participants following the completion of our program. We also conclude that our app or program demonstrated feasibility (ie, acceptability, practicality, implementation, and efficacy) and can provide a much-needed resource for primary caregivers of persons with dementia. In the subsequent version of the program, we will respond to participant feedback by incorporating web-based weekly sessions and incorporating an outcome measure of self-compassion. %M 34842530 %R 10.2196/28652 %U https://aging.jmir.org/2021/4/e28652 %U https://doi.org/10.2196/28652 %U http://www.ncbi.nlm.nih.gov/pubmed/34842530 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 11 %P e27404 %T Self-directed Technology-Based Therapeutic Methods for Adult Patients Receiving Mental Health Services: Systematic Review %A Saad,Anthony %A Bruno,Deanna %A Camara,Bettina %A D’Agostino,Josephine %A Bolea-Alamanac,Blanca %+ Department of Psychiatry, Women's College Hospital, 76 Grenville St, Toronto, ON, M5S 1B2, Canada, 1 6473312707, Blanca.BoleaAlamanac@wchospital.ca %K digital therapeutics %K self-directed %K mental health %K telehealth %K technology %K mobile applications %K telemedicine %K internet %K mobile phone %D 2021 %7 26.11.2021 %9 Review %J JMIR Ment Health %G English %X Background: Technological interventions used to treat illnesses and promote health are grouped under the umbrella term of digital therapeutics. The use of digital therapeutics is becoming increasingly common in mental health. Although many technologies are currently being implemented, research supporting their usability, efficacy, and risk requires further examination, especially for those interventions that can be used without support. Objective: This review aims to identify the evidence-based, self-directed, technology-based methods of care that can be used in adult patients after they are discharged from mental health services. The interventions reviewed are automated with no human input required (either at the patient’s or at the technology’s end), so the patients can implement them without any support. Methods: A systematic review was conducted according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and PROSPERO (International Prospective Register of Systematic Reviews) guidelines in 3 databases: PubMed, Web of Science, and OVID. The inclusion criteria were self-directed, automated, and technology-based interventions related to mental health, primarily for adults, having a solid evaluation process. The interventions had to be self-directed, in that the participants could use the technology without any external guidance. Results: We identified 36 papers that met the inclusion criteria: 26 randomized controlled trials, 9 nonrandomized controlled trial quantitative studies, and 1 qualitative study. The technologies used included websites, automated text messaging, phone apps, videos, computer software, and integrated voice response. There were 22 studies focused on internet-based cognitive behavioral therapies as a therapeutic paradigm compared with the waitlist, web-based human-delivered therapy, and other interventions. Among these studies, 14 used paradigms other than the internet-based cognitive behavioral therapy. Of the 8 studies comparing guided and unguided digital care, 3 showed no differences, 3 favored guided interventions, and 2 favored unguided interventions. The research also showed that dropout rates were as high as 80%, citing potential problems with the acceptability of the suggested technologies. Conclusions: There is limited research on the efficacy and suitability of self-directed technology-based care options for mental health. Digital technologies have the potential to bridge the gap between ambulatory care and independent living. However, these interventions may need to be developed collaboratively with the users to encourage their acceptability and to avoid high dropout rates. %M 34842556 %R 10.2196/27404 %U https://mental.jmir.org/2021/11/e27404 %U https://doi.org/10.2196/27404 %U http://www.ncbi.nlm.nih.gov/pubmed/34842556 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e25466 %T Electrophysiological Brain Changes Associated With Cognitive Improvement in a Pediatric Attention Deficit Hyperactivity Disorder Digital Artificial Intelligence-Driven Intervention: Randomized Controlled Trial %A Medina,Rafael %A Bouhaben,Jaime %A de Ramón,Ignacio %A Cuesta,Pablo %A Antón-Toro,Luis %A Pacios,Javier %A Quintero,Javier %A Ramos-Quiroga,Josep Antoni %A Maestú,Fernando %+ Sincrolab Ltd, Prensa 7, Madrid, 28033, Spain, 34 630 364 425, nacho@sincrolab.es %K ADHD %K cognitive stimulation %K magnetoencephalography %K artificial intelligence %K Conners continuous performance test %K KAD_SCL_01 %K AI %K cognitive impairment %K attention deficit hyperactivity disorder %K pediatrics %K children %K rehabilitation %D 2021 %7 26.11.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Cognitive stimulation therapy appears to show promising results in the rehabilitation of impaired cognitive processes in attention deficit hyperactivity disorder. Objective: Encouraged by this evidence and the ever-increasing use of technology and artificial intelligence for therapeutic purposes, we examined whether cognitive stimulation therapy implemented on a mobile device and controlled by an artificial intelligence engine can be effective in the neurocognitive rehabilitation of these patients. Methods: In this randomized study, 29 child participants (25 males) underwent training with a smart, digital, cognitive stimulation program (KAD_SCL_01) or with 3 commercial video games for 12 weeks, 3 days a week, 15 minutes a day. Participants completed a neuropsychological assessment and a preintervention and postintervention magnetoencephalography study in a resting state with their eyes closed. In addition, information on clinical symptoms was collected from the child´s legal guardians. Results: In line with our main hypothesis, we found evidence that smart, digital, cognitive treatment results in improvements in inhibitory control performance. Improvements were also found in visuospatial working memory performance and in the cognitive flexibility, working memory, and behavior and general executive functioning behavioral clinical indexes in this group of participants. Finally, the improvements found in inhibitory control were related to increases in alpha-band power in all participants in the posterior regions, including 2 default mode network regions of the interest: the bilateral precuneus and the bilateral posterior cingulate cortex. However, only the participants who underwent cognitive stimulation intervention (KAD_SCL_01) showed a significant increase in this relationship. Conclusions: The results seem to indicate that smart, digital treatment can be effective in the inhibitory control and visuospatial working memory rehabilitation in patients with attention deficit hyperactivity disorder. Furthermore, the relation of the inhibitory control with alpha-band power changes could mean that these changes are a product of plasticity mechanisms or changes in the neuromodulatory dynamics. Trial Registration: ISRCTN Registry ISRCTN71041318; https://www.isrctn.com/ISRCTN71041318 %M 34842533 %R 10.2196/25466 %U https://www.jmir.org/2021/11/e25466 %U https://doi.org/10.2196/25466 %U http://www.ncbi.nlm.nih.gov/pubmed/34842533 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 4 %N 4 %P e30160 %T Digital Interventions to Promote Healthy Eating in Children: Umbrella Review %A Prowse,Rachel %A Carsley,Sarah %+ Division of Community Health and Humanities, Faculty of Medicine, Memorial University of Newfoundland, 300 Prince Philip Drive, St. John's, NL, A1B 3V6, Canada, 1 709 864 6622, rprowse@mun.ca %K children %K healthy eating %K eHealth %K nutrition intervention %K nutrition education %K food literacy %K digital health %K virtual delivery %K digital interventions %K nutrition interventions %K best practices %K education %K mobile phone %D 2021 %7 25.11.2021 %9 Review %J JMIR Pediatr Parent %G English %X Background: eHealth and web-based service delivery have become increasingly common during the COVID-19 pandemic. Digital interventions may be highly appealing to young people; however, their effectiveness compared with that of the usual face-to-face interventions is unknown. As nutrition interventions merge with the digital world, there is a need to determine the best practices for digital interventions for children. Objective: The aim of this study is to examine the effectiveness of digital nutrition interventions for children on dietary outcomes compared with status quo interventions (eg, conventional face-to-face programming or nondigital support). Methods: We conducted an umbrella review of systematic reviews of studies assessing primary research on digital interventions aimed at improving food and nutrition outcomes for children aged <18 years compared with conventional nutrition education were eligible for inclusion. Results: In total, 11 systematic reviews published since 2015 were included (7/11, 64%, were of moderate quality). Digital interventions ranged from internet, computer, or mobile interventions to websites, programs, apps, email, videos, CD-ROMs, games, telehealth, SMS text messages, and social media, or a combination thereof. The dose and duration of the interventions varied widely (single to multiple exposures; 1-60 minutes). Many studies have been informed by theory or used behavior change techniques (eg, feedback, goal-setting, and tailoring). The effect of digital nutrition interventions for children on dietary outcomes is small and inconsistent. Digital interventions seemed to be the most promising for improving fruit and vegetable intake compared with other nutrition outcomes; however, reviews have found mixed results. Conclusions: Owing to the heterogeneity and duration of digital interventions, follow-up evaluations, comparison groups, and outcomes measured, the effectiveness of these interventions remains unclear. High-quality evidence with common definitions for digital intervention types evaluated with validated measures is needed to improve the state of evidence, to inform policy and program decisions for health promotion in children. Now is the time for critical, robust evaluation of the adopted digital interventions during and after the COVID-19 pandemic to establish best practices for nutrition interventions for children. %M 34842561 %R 10.2196/30160 %U https://pediatrics.jmir.org/2021/4/e30160 %U https://doi.org/10.2196/30160 %U http://www.ncbi.nlm.nih.gov/pubmed/34842561 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e29666 %T Effects of Internet-Based Cognitive Behavioral Therapy for Harmful Alcohol Use and Alcohol Dependence as Self-help or With Therapist Guidance: Three-Armed Randomized Trial %A Johansson,Magnus %A Berman,Anne H %A Sinadinovic,Kristina %A Lindner,Philip %A Hermansson,Ulric %A Andréasson,Sven %+ Department of Global Public Health, Karolinska Institutet, Solnavägen 1E, Stockholm, 11365, Sweden, 46 727249971, magnus.johansson.1@ki.se %K alcohol dependence %K alcohol use disorders %K internet-based interventions %K internet-based cognitive behavioral therapy %K ICBT %K cognitive behavioral therapy %K CBT %K eHealth %K alcohol use %K substance abuse %K outcomes %K help-seeking behavior %K internet-based interventions %K alcohol dependence %K mobile phone %D 2021 %7 24.11.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Alcohol use is a major contributor to health loss. Many persons with harmful use or alcohol dependence do not obtain treatment because of limited availability or stigma. They may use internet-based interventions as an alternative way of obtaining support. Internet-based interventions have previously been shown to be effective in reducing alcohol consumption in studies that included hazardous use; however, few studies have been conducted with a specific focus on harmful use or alcohol dependence. The importance of therapist guidance in internet-based cognitive behavioral therapy (ICBT) programs is still unclear. Objective: This trial aims to investigate the effects of a web-based alcohol program with or without therapist guidance among anonymous adult help-seekers. Methods: A three-armed randomized controlled trial was conducted to compare therapist-guided ICBT and self-help ICBT with an information-only control condition. Swedish-speaking adult internet users with alcohol dependence (3 or more International Classification of Diseases, Tenth Revision criteria) or harmful alcohol use (alcohol use disorder identification test>15) were included in the study. Participants in the therapist-guided ICBT and self-help ICBT groups had 12-week access to a program consisting of 5 main modules, as well as a drinking calendar with automatic feedback. Guidance was given by experienced therapists trained in motivational interviewing. The primary outcome measure was weekly alcohol consumption in standard drinks (12 g of ethanol). Secondary outcomes were alcohol-related problems measured using the total alcohol use disorder identification test-score, diagnostic criteria for alcohol dependence and alcohol use disorder, depression, anxiety, health, readiness to change, and access to other treatments or support. Follow-up was conducted 3 (posttreatment) and 6 months after recruitment. Results: During the recruitment period, from March 2015 to March 2017, 1169 participants were included. Participants had a mean age of 45 (SD 13) years, and 56.72% (663/1169) were women. At the 3-month follow-up, the therapist-guided ICBT and control groups differed significantly in weekly alcohol consumption (−3.84, 95% Cl −6.53 to −1.16; t417=2.81; P=.005; Cohen d=0.27). No significant differences were found in weekly alcohol consumption between the self-help ICBT group and the therapist-guided ICBT at 3 months, between the self-help ICBT and the control group at 3 months, or between any of the groups at the 6-month follow-up. A limitation of the study was the large number of participants who were completely lost to follow-up (477/1169, 40.8%). Conclusions: In this study, a therapist-guided ICBT program was not found to be more effective than the same program in a self-help ICBT version for reducing alcohol consumption or other alcohol-related outcomes. In the short run, therapist-guided ICBT was more effective than information. Only some internet help-seekers may need a multisession program and therapist guidance to change their drinking when they use internet-based interventions. Trial Registration: ClinicalTrials.gov NCT02377726; https://clinicaltrials.gov/ct2/show/NCT02377726 %M 34821563 %R 10.2196/29666 %U https://www.jmir.org/2021/11/e29666 %U https://doi.org/10.2196/29666 %U http://www.ncbi.nlm.nih.gov/pubmed/34821563 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 11 %P e24332 %T Implementation Outcome Scales for Digital Mental Health (iOSDMH): Scale Development and Cross-sectional Study %A Sasaki,Natsu %A Obikane,Erika %A Vedanthan,Rajesh %A Imamura,Kotaro %A Cuijpers,Pim %A Shimazu,Taichi %A Kamada,Masamitsu %A Kawakami,Norito %A Nishi,Daisuke %+ Department of Mental Health, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan, 81 3 5841 3521, d-nishi@m.u-tokyo.ac.jp %K implementation outcomes %K acceptability %K appropriateness %K feasibility %K harm %D 2021 %7 23.11.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital mental health interventions are being used more than ever for the prevention and treatment of psychological problems. Optimizing the implementation aspects of digital mental health is essential to deliver the program to populations in need, but there is a lack of validated implementation outcome measures for digital mental health interventions. Objective: The primary aim of this study is to develop implementation outcome scales of digital mental health for different levels of stakeholders involved in the implementation process: users, providers, and managers or policy makers. The secondary aim is to validate the developed scale for users. Methods: We developed English and Japanese versions of the implementation outcome scales for digital mental health (iOSDMH) based on the literature review and panel discussions with experts in implementation research and web-based psychotherapy. The study developed acceptability, appropriateness, feasibility, satisfaction, and harm as the outcome measures for users, providers, and managers or policy makers. We conducted evidence-based interventions via the internet using UTSMeD, a website for mental health information (N=200). Exploratory factor analysis (EFA) was conducted to assess the structural validity of the iOSDMH for users. Satisfaction, which consisted of a single item, was not included in the EFA. Results: The iOSDMH was developed for users, providers, and managers or policy makers. The iOSDMH contains 19 items for users, 11 items for providers, and 14 items for managers or policy makers. Cronbach α coefficients indicated intermediate internal consistency for acceptability (α=.665) but high consistency for appropriateness (α=.776), feasibility (α=.832), and harm (α=.777) of the iOSDMH for users. EFA revealed 3-factor structures, indicating acceptability and appropriateness as close concepts. Despite the similarity between these 2 concepts, we inferred that acceptability and appropriateness should be used as different factors, following previous studies. Conclusions: We developed iOSDMH for users, providers, and managers. Psychometric assessment of the scales for users demonstrated acceptable reliability and validity. Evaluating the components of digital mental health implementation is a major step forward in implementation science. %M 34817391 %R 10.2196/24332 %U https://formative.jmir.org/2021/11/e24332 %U https://doi.org/10.2196/24332 %U http://www.ncbi.nlm.nih.gov/pubmed/34817391 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e30690 %T Clinical Effectiveness and Cost-effectiveness of Videoconference-Based Integrated Cognitive Behavioral Therapy for Chronic Pain: Randomized Controlled Trial %A Taguchi,Kayoko %A Numata,Noriko %A Takanashi,Rieko %A Takemura,Ryo %A Yoshida,Tokiko %A Kutsuzawa,Kana %A Yoshimura,Kensuke %A Nozaki-Taguchi,Natsuko %A Ohtori,Seiji %A Shimizu,Eiji %+ Research Center for Child Mental Development, Chiba University, Inohana 1-8-1, Chuo-ku, Chiba, 260-8670, Japan, 81 043 226 2027 ext 5208, k.taguchi@chiba-u.jp %K cognitive behavioral therapy %K chronic pain %K medical economic evaluation %K EQ-5D-5L %K telemedicine %D 2021 %7 22.11.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Cognitive behavioral therapy is known to improve the management of chronic pain. However, the components of this therapy are still being investigated and debated. Objective: This study aimed to examine the effectiveness of an integrated cognitive behavioral therapy program with new components (attention-shift, memory work, video feedback, and image training) delivered via videoconferencing. Methods: This study was unblinded and participants were recruited and assessed face-to-face in the outpatient department. We conducted a randomized controlled trial for chronic pain to compare 16 weekly videoconference-based cognitive behavioral therapy (vCBT) sessions provided by a therapist with treatment as usual (TAU). Thirty patients (age range, 22-75 years) with chronic pain were randomly assigned to either vCBT (n=15) or TAU (n=15). Patients were evaluated at week 1 (baseline), week 8 (midintervention), and week 16 (postintervention). The primary outcome was the change in pain intensity, which was recorded using the numerical rating scale at 16 weeks from the baseline. Secondary outcomes were pain severity and pain interference, which were assessed using the Brief Pain Inventory. Additionally, we evaluated disability, pain catastrophizing cognition, depression, anxiety, quality of life, and cost utility. Results: In the eligibility assessment, 30 patients were eventually randomized and enrolled; finally, 15 patients in the vCBT and 14 patients in the TAU group were analyzed. Although no significant difference was found between the 2 groups in terms of changes in pain intensity by the numerical rating scale scores at week 16 from baseline (P=.36), there was a significant improvement in the comprehensive evaluation of pain by total score of Brief Pain Inventory (–1.43, 95% CI –2.49 to –0.37, df=24; P=.01). Further, significant improvement was seen in pain interference by using the Brief Pain Inventory (–9.42, 95% CI –14.47 to –4.36, df=25; P=.001) and in disability by using the Pain Disability Assessment Scale (–1.95, 95% CI –3.33 to –0.56, df=24; P=.008) compared with TAU. As for the Medical Economic Evaluation, the incremental cost-effectiveness ratio for 1 year was estimated at 2.9 million yen (about US $25,000) per quality-adjusted life year gained. Conclusions: The findings of our study suggest that integrated cognitive behavioral therapy delivered by videoconferencing in regular medical care may reduce pain interference but not pain intensity. Further, this treatment method may be cost-effective, although this needs to be further verified using a larger sample size. Trial Registration: University Hospital Medical Information Network UMIN000031124; https://tinyurl.com/2pr3xszb %M 34813489 %R 10.2196/30690 %U https://www.jmir.org/2021/11/e30690 %U https://doi.org/10.2196/30690 %U http://www.ncbi.nlm.nih.gov/pubmed/34813489 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e29664 %T Reactance to Social Authority in a Sugar Reduction Informational Video: Web-Based Randomized Controlled Trial of 4013 Participants %A Hachaturyan,Violetta %A Adam,Maya %A Favaretti,Caterina %A Greuel,Merlin %A Gates,Jennifer %A Bärnighausen,Till %A Vandormael,Alain %+ Heidelberg Institute of Global Health, University of Heidelberg, 130.3 Im Neuenheimer Feld, Heidelberg, 69210, Germany, 49 6221 56 5344, alain.vandormael@uni-heidelberg.de %K sugar reduction %K reactance %K animated video %K digital intervention %K health communication %D 2021 %7 22.11.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Short and animated story-based (SAS) videos can be an effective strategy for promoting health messages. However, health promotion strategies often motivate the rejection of health messages, a phenomenon known as reactance. In this study, we examine whether the child narrator of a SAS video (perceived as nonthreatening, with low social authority) minimizes reactance to a health message about the consumption of added sugars. Objective: This study aims to determine whether our SAS intervention video attenuates reactance to the sugar message when compared with a content placebo video (a health message about sunscreen) and a placebo video (a nonhealth message about earthquakes) and determine if the child narrator is more effective at reducing reactance to the sugar message when compared with the mother narrator (equivalent social authority to target audience) or family physician narrator (high social authority) of the same SAS video. Methods: This is a web-based randomized controlled trial comparing an intervention video about sugar reduction narrated by a child, the child’s mother, or the family physician with a content placebo video about sunscreen use and a placebo video about earthquakes. The primary end points are differences in the antecedents to reactance (proneness to reactance, threat level of the message), its components (anger and negative cognition), and outcomes (source appraisal and attitude). We performed analysis of variance on data collected (N=4013) from participants aged 18 to 59 years who speak English and reside in the United Kingdom. Results: Between December 9 and December 11, 2020, we recruited 38.62% (1550/4013) men, 60.85% (2442/4013) women, and 0.52% (21/4013) others for our study. We found a strong causal relationship between the persuasiveness of the content promoted by the videos and the components of reactance. Compared with the placebo (mean 1.56, SD 0.63) and content placebo (mean 1.76, SD 0.69) videos, the intervention videos (mean 1.99, SD 0.83) aroused higher levels of reactance to the message content (P<.001). We found no evidence that the child narrator (mean 1.99, SD 0.87) attenuated reactance to the sugar reduction message when compared with the physician (mean 1.95, SD 0.79; P=.77) and mother (mean 2.03, SD 0.83; P=.93). In addition, the physician was perceived as more qualified, reliable, and having more expertise than the child (P<.001) and mother (P<.001) narrators. Conclusions: Although children may be perceived as nonthreatening messengers, we found no evidence that a child narrator attenuated reactance to a SAS video about sugar consumption when compared with a physician. Furthermore, our intervention videos, with well-intended goals toward audience health awareness, aroused higher levels of reactance when compared with the placebo videos. Our results highlight the challenges in developing effective interventions to promote persuasive health messages. Trial Registration: German Clinical Trials Registry DRKS00022340; https://tinyurl.com/mr8dfena International Registered Report Identifier (IRRID): RR2-10.2196/25343 %M 34813490 %R 10.2196/29664 %U https://www.jmir.org/2021/11/e29664 %U https://doi.org/10.2196/29664 %U http://www.ncbi.nlm.nih.gov/pubmed/34813490 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 4 %N 4 %P e27630 %T Internet-Based Psychotherapy Intervention for Depression Among Older Adults Receiving Home Care: Qualitative Study of Participants’ Experiences %A Xiang,Xiaoling %A Kayser,Jay %A Sun,Yihang %A Himle,Joseph %+ School of Social Work, University of Michigan, 1080 S University Ave, Ann Arbor, MI, 48109, United States, 1 7347636581, xiangxi@umich.edu %K internet-based cognitive behavioral therapy %K homebound older adults %K home care %K direct care workers %K depression %K qualitative study %D 2021 %7 22.11.2021 %9 Original Paper %J JMIR Aging %G English %X Background: Depression is common among homebound older adults. Internet-based cognitive behavioral therapy (iCBT) is a promising but understudied approach for treating depression among older adults with disabilities. Objective: This study aims to understand the experiences of homebound older adults who participated in a pilot feasibility trial of an iCBT for depression. Methods: The participants included 21 homebound older adults who participated in a generic iCBT program that was not specifically designed for older adults and 8 home care workers who assisted in the iCBT program. Informants completed semistructured individual interviews, which were transcribed verbatim and analyzed using methods informed by grounded theory. A hierarchical code structure of themes and subthemes was developed after an iterative process of constant comparisons and questionings of the initial codes. The data analysis was conducted by using dedoose, a web app for mixed methods research. Results: Three themes and various subthemes emerged related to participants’ experience of the iCBT intervention, as follows: intervention impact, which involved subthemes related to participants’ perceived impact of the intervention; challenges and difficulties, which involved subthemes on the challenges and difficulties that participants experienced in the intervention; and facilitators, which involved subthemes on the factors that facilitated intervention use and engagement. Conclusions: iCBT is a promising intervention for homebound older adults experiencing depression. Home care workers reported improved relationships with their clients and that the program did not add a burden to their duties. Future programs should involve accessible technical features and age-adapted content to improve user experience, uptake, and adherence. Trial Registration: ClinicalTrials.gov NCT04267289; https://clinicaltrials.gov/ct2/show/NCT04267289 %M 34813491 %R 10.2196/27630 %U https://aging.jmir.org/2021/4/e27630 %U https://doi.org/10.2196/27630 %U http://www.ncbi.nlm.nih.gov/pubmed/34813491 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 11 %P e32306 %T A Smartphone-Based Self-Management Intervention for Individuals with Bipolar Disorder (LiveWell): Qualitative Study on User Experiences of the Behavior Change Process %A Jonathan,Geneva K %A Dopke,Cynthia A %A Michaels,Tania %A Martin,Clair R %A Ryan,Chloe %A McBride,Alyssa %A Babington,Pamela %A Goulding,Evan H %+ Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, 680 N Lake Shore Dr Suite 1520, Chicago, IL, 60660, United States, 1 312 503 1189, e-goulding@fsm.northwestern.edu %K behavioral intervention technology %K mHealth %K bipolar disorder %K depression %K illness management %K smartphone %K behavior change %K early warning signs %K self-management %K qualitative %K behavior %K intervention %K management %K user experience %K perception %K utilization %D 2021 %7 22.11.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: Bipolar disorder is a severe mental illness characterized by recurrent episodes of depressed, elevated, and mixed mood states. The addition of psychotherapy to pharmacological management can decrease symptoms, lower relapse rates, and improve quality of life; however, access to psychotherapy is limited. Mental health technologies such as smartphone apps are being studied as a means to increase access to and enhance the effectiveness of adjunctive psychotherapies for bipolar disorder. Individuals with bipolar disorder find this intervention format acceptable, but our understanding of how people utilize and integrate these tools into their behavior change and maintenance processes remains limited. Objective: The objective of this study was to explore how individuals with bipolar disorder perceive and utilize a smartphone intervention for health behavior change and maintenance. Methods: Individuals with bipolar disorder were recruited via flyers placed at university-affiliated and private outpatient mental health practices to participate in a pilot study of LiveWell, a smartphone-based self-management intervention. At the end of the study, all participants completed in-depth qualitative exit interviews. The behavior change framework developed to organize the intervention design was used to deductively code behavioral targets and determinants involved in target engagement. Inductive coding was used to identify themes not captured by this framework. Results: In terms of behavioral targets, participants emphasized the importance of managing mood episode–related signs and symptoms. They also discussed the importance of maintaining regular routines, sleep duration, and medication adherence. Participants emphasized that receiving support from a coach as well as seeking and receiving assistance from family, friends, and providers were important for managing behavioral targets and staying well. In terms of determinants, participants stressed the important role of monitoring for their behavior change and maintenance efforts. Monitoring facilitated self-awareness and reflection, which was considered valuable for staying well. Some participants also felt that the intervention facilitated learning information necessary for managing bipolar disorder but others felt that the information provided was too basic. Conclusions: In addition to addressing acceptability, satisfaction, and engagement, a person-based design of mental health technologies can be used to understand how people experience the impact of these technologies on their behavior change and maintenance efforts. This understanding may then be used to guide ongoing intervention development. The participants’ perceptions aligned with the intervention’s primary behavioral targets and use of a monitoring tool as a core intervention feature. Participant feedback further indicates that developing additional content and tools to address building and engaging social support may be an important avenue for improving LiveWell. A comprehensive behavior change framework to understand participant perceptions of their behavior change and maintenance efforts may help facilitate ongoing intervention development. %M 34813488 %R 10.2196/32306 %U https://mental.jmir.org/2021/11/e32306 %U https://doi.org/10.2196/32306 %U http://www.ncbi.nlm.nih.gov/pubmed/34813488 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 11 %P e30590 %T Effectiveness of Self-Guided Virtual Reality–Based Cognitive Behavioral Therapy for Panic Disorder: Randomized Controlled Trial %A Shin,Bokyoung %A Oh,Jooyoung %A Kim,Byung-Hoon %A Kim,Hesun Erin %A Kim,Hyunji %A Kim,Suji %A Kim,Jae-Jin %+ Department of Psychiatry, Yonsei University College of Medicine, Gangnam Severance Hospital, Yonsei University Health System, 211 Eonju-ro, Gangnam-gu, Seoul, 06273, Republic of Korea, 82 2 2019 3342, ojuojuoju@yuhs.ac %K virtual reality %K panic disorder %K cognitive behavioral therapy %K exposure therapy %K intervention %D 2021 %7 22.11.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: Virtual reality (VR) is as effective a technique as traditional cognitive behavioral therapy (CBT) and a promising tool for treating panic disorder symptoms because VR exposure can be safer and has better acceptability than in vivo exposure and is more immersive than exposure through imagination. CBT techniques can be delivered more effectively using VR as well. So far, VR has required high-quality devices, but the development of mobile VR technology has improved user availability. At the same time, a well-structured form of VR can be reproduced and used anywhere. This means that VR can be used to provide a self-guided form of treatment and address the high treatment costs of evidence-based therapy and the lack of professional therapists. This study aimed to investigate the potential of self-guided VR as an alternative to high-cost treatment. Objective: The main goal of this study was to offer data about the efficacy of a mobile app-based self-led VR CBT in the treatment of panic disorder. Methods: A total of 54 subjects with panic disorder were enrolled in this study and randomly assigned to either the VR treatment group or waitlist group. The VR treatment was designed to be total 12 sessions for 4 weeks. The VR treatment consists of 4 steps in which patients are gradually exposed to phobic stimuli while learning to cope with panic symptoms in each stage. The effectiveness of treatment was assessed through the Panic Disorder Severity Scale, Hamilton Rating Scale for Depression, Body Sensations Questionnaire, Albany Panic and Phobia Questionnaire, Anxiety Sensitivity Index, State-Trait Anxiety Inventory, Hospital Anxiety and Depression Scale, Korean Inventory of Social Avoidance and Distress Scale, Korean Inventory of Depressive Symptomatology, and Perceived Stress Scale. In addition, physiological changes using heart rate variability were evaluated. Results: In within-group analyses, the VR treatment group exhibited improvements in panic disorder symptoms, anxiety, and depression after 4 weeks, while the waitlist group did not show any significant improvement. Compared to the waitlist group, the VR treatment group showed significantly greater improvements in the Panic Disorder Severity Scale in both completer analysis and intention-to-treat analysis. Heart rate variability in the VR treatment group showed improvement in normalized high frequency from baseline to postassessment with no significant differences in any outcome measure between groups. Conclusions: The self-guided, mobile app-based VR intervention was effective in the treatment of panic symptoms and restoring the autonomic nervous system demonstrating the validity of the use of VR for self-guided treatment. VR treatment can be a cost-effective therapeutic approach. Trial Registration: ClinicalTrials.gov NCT04985019; https://clinicaltrials.gov/ct2/show/NCT04985019 %M 34813486 %R 10.2196/30590 %U https://mental.jmir.org/2021/11/e30590 %U https://doi.org/10.2196/30590 %U http://www.ncbi.nlm.nih.gov/pubmed/34813486 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e26480 %T Willingness of Chinese Men Who Have Sex With Men to Use Smartphone-Based Electronic Readers for HIV Self-testing: Web-Based Cross-sectional Study %A Marley,Gifty %A Fu,Gengfeng %A Zhang,Ye %A Li,Jianjun %A Tucker,Joseph D %A Tang,Weiming %A Yu,Rongbin %+ School of Public Health, Nanjing Medical University, 101 Longmian Avenue, Jiangning District, Nanjing, 211166, China, 86 13851545125, rongbinyu@njmu.edu.cn %K smartphone-based electronic reader %K electronic readers %K HIV self-testing %K HIVST %K self-testing %K cellular phone–based readers %K mHealth %D 2021 %7 19.11.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The need for strategies to encourage user-initiated reporting of results after HIV self-testing (HIVST) persists. Smartphone-based electronic readers (SERs) have been shown capable of reading diagnostics results accurately in point-of-care diagnostics and could bridge the current gaps between HIVST and linkage to care. Objective: Our study aimed to assess the willingness of Chinese men who have sex with men (MSM) in the Jiangsu province to use an SER for HIVST through a web-based cross-sectional study. Methods: From February to April 2020, we conducted a convenience web-based survey among Chinese MSM by using a pretested structured questionnaire. Survey items were adapted from previous HIVST feasibility studies and modified as required. Prior to answering reader-related questions, participants watched a video showcasing a prototype SER. Statistical analysis included descriptive analysis, chi-squared test, and multivariable logistic regression. P values less than .05 were deemed statistically significant. Results: Of 692 participants, 369 (53.3%) were aged 26-40 years, 456 (65.9%) had ever self-tested for HIV, and 493 (71.2%) were willing to use an SER for HIVST. Approximately 98% (483/493) of the willing participants, 85.3% (459/538) of ever self-tested and never self-tested, and 40% (46/115) of unwilling participants reported that SERs would increase their HIVST frequency. Engaging in unprotected anal intercourse with regular partners compared to consistently using condoms (adjusted odds ratio [AOR] 3.04, 95% CI 1.19-7.74) increased the odds of willingness to use an SER for HIVST. Participants who had ever considered HIVST at home with a partner right before sex compared to those who had not (AOR 2.99, 95% CI 1.13-7.90) were also more willing to use an SER for HIVST. Playing receptive roles during anal intercourse compared to playing insertive roles (AOR 0.05, 95% CI 0.02-0.14) was associated with decreased odds of being willing to use an SER for HIVST. The majority of the participants (447/608, 73.5%) preferred to purchase readers from local Centers of Disease Control and Prevention offices and 51.2% (311/608) of the participants were willing to pay less than US $4.70 for a reader device. Conclusions: The majority of the Chinese MSM, especially those with high sexual risk behaviors, were willing to use an SER for HIVST. Many MSM were also willing to self-test more frequently for HIV with an SER. Further research is needed to ascertain the diagnostic and real-time data-capturing capacity of prototype SERs during HIVST. %M 34806988 %R 10.2196/26480 %U https://www.jmir.org/2021/11/e26480 %U https://doi.org/10.2196/26480 %U http://www.ncbi.nlm.nih.gov/pubmed/34806988 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 8 %N 4 %P e26612 %T Digital Therapeutic Care and Decision Support Interventions for People With Low Back Pain: Systematic Review %A Lewkowicz,Daniel %A Slosarek,Tamara %A Wernicke,Sarah %A Winne,Antonia %A Wohlbrandt,Attila M %A Bottinger,Erwin %+ Digital Health Center, Hasso Plattner Institute, University of Potsdam, Prof.-Dr.-Helmert-Str. 2-3, Potsdam, 14482, Germany, 49 (0)331 55094843, daniel.lewkowicz@hpi.de %K digital therapeutic care %K decision support interventions %K low back pain %K behavior change techniques %K back %K orthopedic %K systematic review %K digital therapy %K decision support %K mobile phone %D 2021 %7 19.11.2021 %9 Review %J JMIR Rehabil Assist Technol %G English %X Background: Low back pain (LBP) is the leading cause of worldwide years lost because of disability, with a tremendous economic burden for health care systems. Digital therapeutic care (DTC) programs provide a scalable, universally accessible, and low-cost approach to the multidisciplinary treatment of LBP. Moreover, novel decision support interventions such as personalized feedback messages, push notifications, and data-driven activity recommendations amplify DTC by guiding the user through the program while aiming to increase overall engagement and sustainable behavior change. Objective: This systematic review aims to synthesize recent scientific literature on the impact of DTC apps for people with LBP and outline the implementation of add-on decision support interventions, including their effect on user retention and attrition rates. Methods: We searched bibliographic databases, including MEDLINE, Cochrane Library, Web of Science, and the Physiotherapy Evidence Database, from March 1, 2016, to October 15, 2020, in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and conducted this review based on related previously published systematic reviews. Besides randomized controlled trials (RCTs), we also included study designs with the evidence level of at least a retrospective comparative study. This enables the consideration of real-world user-generated data and provides information regarding the adoption and effectiveness of DTC apps in a real-life setting. For the appraisal of the risk of bias, we used the Risk of Bias 2 Tool and the Risk of Bias in Non-Randomized Studies of Interventions Tool for the RCTs and nonrandomized trials, respectively. The included studies were narratively synthesized regarding primary and secondary outcome measures, DTC components, applied decision support interventions, user retention, and attrition rates. Results: We retrieved 1388 citations, of which 12 studies are included in this review. Of the 12 studies, 6 (50%) were RCTs and 6 (50%) were nonrandomized trials. In all included studies, lower pain levels and increased functionality compared with baseline values were observed in the DTC intervention group. A between-group comparison revealed significant improvements in pain and functionality levels in 67% (4/6) of the RCTs. The study population was mostly homogeneous, with predominantly female, young to middle-aged participants of normal to moderate weight. The methodological quality assessment revealed moderate to high risks of biases, especially in the nonrandomized trials. Conclusions: This systematic review demonstrates the benefits of DTC for people with LBP. There is also evidence that decision support interventions benefit overall engagement with the app and increase participants’ ability to self-manage their recovery process. Finally, including retrospective evaluation studies of real-world user-generated data in future systematic reviews of digital health intervention trials can reveal new insights into the benefits, challenges, and real-life adoption of DTC programs. %M 34807837 %R 10.2196/26612 %U https://rehab.jmir.org/2021/4/e26612 %U https://doi.org/10.2196/26612 %U http://www.ncbi.nlm.nih.gov/pubmed/34807837 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 5 %N 2 %P e27016 %T Usability and Perceived Usefulness of the AFib 2gether Mobile App in a Clinical Setting: Single-Arm Intervention Study %A Kapoor,Alok %A Hayes,Anna %A Patel,Jay %A Patel,Harshal %A Andrade,Andreza %A Mazor,Kathleen %A Possidente,Carl %A Nolen,Kimberly %A Hegeman-Dingle,Rozelle %A McManus,David %+ Department of Medicine, University of Massachusetts Chan Medical School, 55 North Lake Ave, Worcester, MA, 01655, United States, 1 9178564538, alok.kapoor@umassmemorial.org %K shared decision-making %K mobile health %K stroke risk %K anticoagulation risk %K anticoagulation %K atrial fibrillation %K anticoagulation therapy %K atrial flutter %K mobile phone %D 2021 %7 19.11.2021 %9 Original Paper %J JMIR Cardio %G English %X Background: Although the American Heart Association and other professional societies have recommended shared decision-making as a way for patients with atrial fibrillation (AF) or atrial flutter to make informed decisions about using anticoagulation (AC), the best method for facilitating shared decision-making remains uncertain. Objective: The aim of this study is to assess the AFib 2gether mobile app for usability, perceived usefulness, and the extent and nature of shared decision-making that occurred for clinical encounters between patients with AF and their cardiology providers in which the app was used. Methods: We identified patients visiting a cardiology provider between October 2019 and May 2020. We measured usability from patients and providers using the Mobile App Rating Scale. From the 8 items of the Mobile App Rating Scale, we reported the average score (out of 5) for domains of functionality, esthetics, and overall quality. We administered a 3-item questionnaire to patients relating to their perceived usefulness of the app and a separate 3-item questionnaire to providers to measure their perceived usefulness of the app. We performed a chart review to track the occurrence of AC within 6 months of the index visit. We also audio recorded a subset of the encounters to identify evidence of shared decision-making. Results: We facilitated shared decision-making visits for 37 patients visiting 13 providers. In terms of usability, patients’ average ratings of functionality, esthetics, and overall quality were 4.51 (SD 0.61), 4.26 (SD 0.51), and 4.24 (SD 0.89), respectively. In terms of usefulness, 41% (15/37) of patients agreed that the app improved their knowledge regarding AC, and 62% (23/37) agreed that the app helped clarify to their provider their preferences regarding AC. Among providers, 79% (27/34) agreed that the app helped clarify their patients’ preferences, 82% (28/34) agreed that the app saved them time, and 59% (20/34) agreed that the app helped their patients make decisions about AC. In addition, 32% (12/37) of patients started AC after their shared decision-making visits. We audio recorded 25 encounters. Of these, 84% (21/25) included the mention of AC for AF, 44% (11/25) included the discussion of multiple options for AC, 72% (18/25) included a provider recommendation for AC, and 48% (12/25) included the evidence of patient involvement in the discussion. Conclusions: Patients and providers rated the app with high usability and perceived usefulness. Moreover, one-third of the patients began AC, and approximately 50% (12/25) of the encounters showed evidence of patient involvement in decision-making. In the future, we plan to study the effect of the app on a larger sample and with a controlled study design. Trial Registration: ClinicalTrials.gov NCT04118270; https://clinicaltrials.gov/ct2/show/NCT04118270 International Registered Report Identifier (IRRID): RR2-21986 %M 34806997 %R 10.2196/27016 %U https://cardio.jmir.org/2021/2/e27016 %U https://doi.org/10.2196/27016 %U http://www.ncbi.nlm.nih.gov/pubmed/34806997 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 11 %P e31041 %T A Web-Based Risk-Reframing Intervention to Influence Early Childhood Educators’ Attitudes and Supportive Behaviors Toward Outdoor Play: Protocol for the OutsidePlay Study Randomized Controlled Trial %A Brussoni,Mariana %A Han,Christina S %A Jacob,John %A Munday,Fritha %A Zeni,Megan %A Walters,Melanie %A Cheng,Tina %A Schneeberg,Amy %A Fox,Emily %A Oberle,Eva %+ Department of Pediatrics, University of British Columbia, F511-4480 Oak St, Vancouver, BC, V6H 0B3, Canada, 1 604 875 3712, mbrussoni@bcchr.ubc.ca %K early years %K risky play %K teacher %K childcare %K early learning %K risk perception %K outdoor play %D 2021 %7 18.11.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Early learning and childcare centers (ELCCs) can offer young children critical opportunities for quality outdoor play. There are multiple actual and perceived barriers to outdoor play at ELCCs, ranging from safety fears and lack of familiarity with supporting play outdoors to challenges around diverse perspectives on outdoor play among early childhood educators (ECEs), administrators, licensing officers, and parents. Objective: Our study objective is to develop and evaluate a web-based intervention that influences ECEs’ and ELCC administrators’ perceptions and practices in support of children’s outdoor play at ELCCs. Methods: The development of the fully automated, open-access, web-based intervention was guided by the intervention mapping process. We first completed a needs assessment through focus groups of ECEs, ELCC administrators, and licensing officers. We identified key issues, needs, and challenges; opportunities to influence behavior change; and intervention outcomes and objectives. This enabled us to develop design objectives and identify features of the OutsidePlay web-based intervention that are central to addressing the issues, needs, and challenges of ECEs and ELCC administrators. We used social cognitive theory and behavior change techniques to select methods, applications, and technology to deliver the intervention. We will use a two-parallel-group randomized controlled trial (RCT) design to evaluate the efficacy of the intervention. We will recruit 324 ECEs and ELCC administrators through a variety of web-based means, including Facebook advertisements and mass emails through our partner networks. The RCT study will be a purely web-based trial where outcomes will be self-assessed through questionnaires. The RCT participants will be randomized into the intervention group or the control group. The control group participants will read the Position Statement on Active Outdoor Play. Results: The primary outcome is increased tolerance of risk in children’s play, as measured by the Teacher Tolerance of Risk in Play Scale. The secondary outcome is self-reported attainment of a self-developed behavior change goal. We will use mixed effects models to test the hypothesis that there will be a difference between the intervention and control groups with respect to tolerance of risk in children’s play. Differences in goal attainment will be tested using logistic regression analysis. Conclusions: The OutsidePlay web-based intervention guides users through a personalized journey that is split into 3 chapters. An effective intervention that addresses the barriers to outdoor play in ELCC settings has the potential to improve children’s access to outdoor play and support high-quality early childhood education. Trial Registration: ClinicalTrials.gov NCT04624932; https://clinicaltrials.gov/ct2/show/NCT04624932 International Registered Report Identifier (IRRID): DERR1-10.2196/31041 %M 34792479 %R 10.2196/31041 %U https://www.researchprotocols.org/2021/11/e31041 %U https://doi.org/10.2196/31041 %U http://www.ncbi.nlm.nih.gov/pubmed/34792479 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e29003 %T Effectiveness of Information and Communication Technology on Obesity in Childhood and Adolescence: Systematic Review and Meta-analysis %A Park,Jihyun %A Park,Mi-Jeong %A Seo,Young-Gyun %+ Department of Family Medicine, Hallym University Sacred Heart Hospital, 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang, 14068, Republic of Korea, 82 31 380 3805, yg035@daum.net %K ICT %K eHealth %K mHealth %K weight loss %K obesity %K BMI %K meta-analysis %K randomized controlled trial %K children %K adolescents %K mobile phone %D 2021 %7 17.11.2021 %9 Review %J J Med Internet Res %G English %X Background: Internet or mobile device use as a form of information and communication technology (ICT) can be more effective in weight loss and weight maintenance than traditional obesity interventions. Objective: The study aims to assess the effectiveness of child-centered ICT interventions on obesity-related outcomes. Methods: Articles were retrieved from the Cochrane Central Register of Controlled Trials, Embase, and PubMed web-based databases. We selected randomized controlled trials in which the participants were aged <18 years. The primary outcomes were BMI, body weight, BMI z-score, waist circumference, and percentage body fat. Results: In total, 10 of the initial 14,867 studies identified in the databases were selected according to the inclusion criteria. A total of 640 participants were included in the intervention group and 619 in the comparator group. Meta-analyses were conducted considering various subgroups (intervention type, comparator type, target participants, mean age, sex, BMI status, and follow-up period). Overall, ICT interventions demonstrated no significant effect on BMI, body weight, BMI z-score, waist circumference, and percentage body fat. Subgroup analyses revealed that the effect of the intervention was statistically significant for the following: web intervention (weighted mean difference [WMD]=−1.26 kg/m2, 95% CI −2.24 to −0.28), lifestyle modification comparator (WMD=−1.75, 95% CI −2.76 to −0.74), intervention involving both boys and girls (WMD=−1.30, 95% CI −2.14 to −0.46), and intervention involving obesity only (WMD=−1.92, 95% CI −3.75 to −0.09). Conclusions: The meta-analysis results for children with obesity who used the web intervention program confirmed significant effects on BMI reduction compared with lifestyle modification. Evidence from the meta-analysis identified internet technology as a useful tool for weight loss in children with obesity. %M 34787572 %R 10.2196/29003 %U https://www.jmir.org/2021/11/e29003 %U https://doi.org/10.2196/29003 %U http://www.ncbi.nlm.nih.gov/pubmed/34787572 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e26931 %T Digital Interventions on Healthy Lifestyle Management: Systematic Review %A Chatterjee,Ayan %A Prinz,Andreas %A Gerdes,Martin %A Martinez,Santiago %+ Department for Information and Communication Technologies, Centre for e-Health, University of Agder, Jon Lilletuns Vei 9, Grimstad, 4879, Norway, 47 94719372, ayan.chatterjee@uia.no %K eHealth %K digital intervention %K lifestyle %K obesity %K challenges %K mobile phone %D 2021 %7 17.11.2021 %9 Review %J J Med Internet Res %G English %X Background: Digital interventions have tremendous potential to improve well-being and health care conveyance by improving adequacy, proficiency, availability, and personalization. They have gained acknowledgment in interventions for the management of a healthy lifestyle. Therefore, we are reviewing existing conceptual frameworks, digital intervention approaches, and associated methods to identify the impact of digital intervention on adopting a healthier lifestyle. Objective: This study aims to evaluate the impact of digital interventions on weight management in maintaining a healthy lifestyle (eg, regular physical activity, healthy habits, and proper dietary patterns). Methods: We conducted a systematic literature review to search the scientific databases (Nature, SpringerLink, Elsevier, IEEE Xplore, and PubMed) that included digital interventions on healthy lifestyle, focusing on preventing obesity and being overweight as a prime objective. Peer-reviewed articles published between 2015 and 2020 were included. We used the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and a framework for an evidence-based systematic review. Furthermore, we improved the review process by adopting the Rayyan tool and the Scale for the Assessment of Narrative Review Articles. Results: Our initial searches identified 780 potential studies through electronic and manual searches; however, 107 articles in the final stage were cited following the specified inclusion and exclusion criteria. The identified methods for a successful digital intervention to promote a healthy lifestyle are self-monitoring, self-motivation, goal setting, personalized feedback, participant engagement, psychological empowerment, persuasion, digital literacy, efficacy, and credibility. In this study, we identified existing conceptual frameworks for digital interventions, different approaches to provide digital interventions, associated methods, and execution challenges and their impact on the promotion of healthy lifestyle management. Conclusions: This systematic literature review selected intervention principles (rules), theories, design features, ways to determine efficient interventions, and weaknesses in healthy lifestyle management from established digital intervention approaches. The results help us understand how digital interventions influence lifestyle management and overcome the existing shortcomings. It serves as a basis for further research with a focus on designing, developing, testing, and evaluating the generation of personalized lifestyle recommendations as a part of digital health interventions. %M 34787575 %R 10.2196/26931 %U https://www.jmir.org/2021/11/e26931 %U https://doi.org/10.2196/26931 %U http://www.ncbi.nlm.nih.gov/pubmed/34787575 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e28185 %T Efficacy of Interventions That Incorporate Mobile Apps in Facilitating Weight Loss and Health Behavior Change in the Asian Population: Systematic Review and Meta-analysis %A Ang,Siew Min %A Chen,Juliana %A Liew,Jia Huan %A Johal,Jolyn %A Dan,Yock Young %A Allman-Farinelli,Margaret %A Lim,Su Lin %+ Department of Dietetics, National University Hospital, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore, 65 67725166, siew_min_ang@nuhs.edu.sg %K systematic review %K meta-analysis %K mobile app %K obesity %K weight loss %K Asian %K diet %K physical activity %K adults %K mobile phone %D 2021 %7 16.11.2021 %9 Review %J J Med Internet Res %G English %X Background: Smartphone apps have shown potential in enhancing weight management in Western populations in the short to medium term. With a rapidly growing obesity burden in Asian populations, researchers are turning to apps as a service delivery platform to reach a larger target audience to efficiently address the problem. Objective: This systematic review and meta-analysis aims to determine the efficacy of interventions that incorporate apps in facilitating weight loss and health behavior change in the Asian population. Methods: A total of 6 databases were searched in June 2020. The eligible studies included controlled trials in which an app was used in the intervention. The participants were aged 18 years or older and were of Asian ethnicity. A meta-analysis to test intervention efficacy, subgroup analyses, and post hoc analyses was conducted to determine the effects of adding an app to usual care and study duration. The primary outcome was absolute or percentage weight change, whereas the secondary outcomes were changes to lifestyle behaviors. Results: A total of 21 studies were included in this review, and 17 (81%) were selected for the meta-analysis. The pooled effect size across 82% (14/17) of the randomized controlled trials for weight change was small to moderate (Hedges g=–0.26; 95% CI –0.41 to –0.11), indicating slightly greater weight loss achieved in the intervention group; however, this may not be representative of long-term studies (lasting for more than a year). Supplementing multicomponent usual care with an app led to greater weight loss (Hedges g=–0.28; 95% CI –0.47 to –0.09). Asian apps were largely culturally adapted and multifunctional, with the most common app features being communication with health professionals and self-monitoring of behaviors and outcomes. Conclusions: More evidence is required to determine the efficacy of apps in the long term and address the low uptake of apps to maximize the potential of the intervention. Future research should determine the efficacy of each component of the multicomponent intervention to facilitate the designing of studies that are most effective and cost-efficient for weight management. Trial Registration: PROSPERO CRD42020165240; https://tinyurl.com/2db4tvn6 %M 34783674 %R 10.2196/28185 %U https://www.jmir.org/2021/11/e28185 %U https://doi.org/10.2196/28185 %U http://www.ncbi.nlm.nih.gov/pubmed/34783674 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 7 %N 4 %P e22140 %T Technology-Based Interventions for Cancer Caregivers: Concept Analysis %A Su,Zhaohui %A Li,Xiaoshan %A McDonnell,Dean %A Fernandez,Andrea A %A Flores,Bertha E %A Wang,Jing %+ Florida State University College of Nursing, 98 Varsity Way, Suite 472B, Tallahassee, FL, 32306-4310, United States, 1 850 644 6844, jingwang@nursing.fsu.edu %K concept analysis %K caregivers %K cancer %K oncology %K technology-based interventions %K mobile phone %D 2021 %7 16.11.2021 %9 Original Paper %J JMIR Cancer %G English %X Background: Cancer is a taxing chronic disease that demands substantial care, most of which is shouldered by informal caregivers. As a result, cancer caregivers often have to manage considerable challenges that could result in severe physical and psychological health consequences. Technology-based interventions have the potential to address many, if not all, of the obstacles caregivers encounter while caring for patients with cancer. However, although the application of technology-based interventions is on the rise, the term is seldom defined in research or practice. Considering that the lack of conceptual clarity of the term could compromise the effectiveness of technology-based interventions for cancer caregivers, timely research is needed to bridge this gap. Objective: This study aims to clarify the meaning of technology-based interventions in the context of cancer caregiving and provide a definition that can be used by cancer caregivers, patients, clinicians, and researchers to facilitate evidence-based research and practice. Methods: The 8-step concept analysis method by Walker and Avant was used to analyze the concept of technology-based interventions in the context of cancer caregiving. PubMed, PsycINFO, CINAHL, and Scopus were searched for studies that examined technology-based interventions for cancer caregivers. Results: The defining attributes of technology-based interventions were recognized as being accessible, affordable, convenient, and user-friendly. On the basis of insights gained on the defining attributes, antecedents to, and consequences of technology-based interventions through the concept analysis process, technology-based interventions were defined as the use of technology to design, develop, and deliver health promotion contents and strategies aimed at inducing or improving positive physical or psychological health outcomes in cancer caregivers. Conclusions: This study clarified the meaning of technology-based interventions in the context of cancer caregiving and provided a clear definition that can be used by caregivers, patients, clinicians, and researchers to facilitate evidence-based oncology practice. A clear conceptualization of technology-based interventions lays foundations for better intervention design and research outcomes, which in turn have the potential to help health care professionals address the needs and preferences of cancer caregivers more cost-effectively. %M 34783664 %R 10.2196/22140 %U https://cancer.jmir.org/2021/4/e22140 %U https://doi.org/10.2196/22140 %U http://www.ncbi.nlm.nih.gov/pubmed/34783664 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 4 %N 4 %P e16824 %T Developing a Management Guide (the DemPower App) for Couples Where One Partner Has Dementia: Nonrandomized Feasibility Study %A Lasrado,Reena %A Bielsten,Therese %A Hann,Mark %A Schumm,James %A Reilly,Siobhan Theresa %A Davies,Linda %A Swarbrick,Caroline %A Dowlen,Robyn %A Keady,John %A Hellström,Ingrid %+ Social Care & Society, The University of Manchester, Oxford Road, Manchester, M13 9PL, United Kingdom, 44 1613067884, reena.lasrado@manchester.ac.uk %K dementia guide %K self-management for couples with dementia %K dementia self-help %K dementia app %K dementia resource %K feasibility study %K nonrandomized study %K dementia intervention %D 2021 %7 16.11.2021 %9 Original Paper %J JMIR Aging %G English %X Background: Promoting the health and well-being of couples where one partner has dementia is an overlooked area of care practice. Most postdiagnostic services currently lack a couple-centered approach and have a limited focus on the couple relationship. To help address this situation, we developed a tablet-based self-management guide (DemPower) focused on helping couples enhance their well-being and relationship quality. Objective: The aim of this study is to investigate the feasibility and acceptability of the DemPower app. Methods: A nonrandomized feasibility design was used to evaluate the DemPower intervention over 3 months among couples where a partner had a diagnosis of dementia. The study recruited 25 couples in the United Kingdom and 19 couples in Sweden. Outcome measures were obtained at baseline and postintervention. The study process and interventions were evaluated at various stages. Results: The study was completed by 48% (21/44) of couples where one partner had dementia, of whom 86% (18/21) of couples accessed all parts of the DemPower app. Each couple spent an average of 8 hours (SD 3.35 hours) using the app during the study period. In total, 90% (19/21) of couples reported that all sections of DemPower were useful in addressing various aspects of daily life and helped to focus on how they interacted in their relationship. Of the 4 core subjects on which the DemPower app was structured, home and neighborhood received the highest number of visits. Couples used activity sections more often than the core subject pages. The perception of DemPower’s utility varied with each couple’s lived experience of dementia, geographic location, relationship dynamics, and opportunities for social interaction. A 5.2-point increase in the dementia quality of life score for people with dementia and a marginal increase in the Mutuality scale (+1.23 points) for caregiver spouses were found. Design and navigational challenges were reported in the DemPower app. Conclusions: The findings suggest that the DemPower app is a useful resource for couples where one partner has dementia and that the implementation of the app requires the support of memory clinics to reach couples at early diagnosis. Trial Registration: ISRCTN Registry ISRCTN10122979; http://www.isrctn.com/ISRCTN10122979 %M 34783666 %R 10.2196/16824 %U https://aging.jmir.org/2021/4/e16824 %U https://doi.org/10.2196/16824 %U http://www.ncbi.nlm.nih.gov/pubmed/34783666 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e29201 %T A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE %A Ben-Zeev,Dror %A Chander,Ayesha %A Tauscher,Justin %A Buck,Benjamin %A Nepal,Subigya %A Campbell,Andrew %A Doron,Guy %+ Behavioral Research in Technology and Engineering Center, Department of Psychiatry and Behavioral Sciences, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, United States, 1 206 685 9655, dbenzeev@uw.edu %K mobile health %K schizophrenia %K bipolar disorder %K depression %K mobile phone %D 2021 %7 12.11.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: People with serious mental illness (SMI) have significant unmet mental health needs. Development and testing of digital interventions that can alleviate the suffering of people with SMI is a public health priority. Objective: The aim of this study is to conduct a fully remote randomized waitlist-controlled trial of CORE, a smartphone intervention that comprises daily exercises designed to promote reassessment of dysfunctional beliefs in multiple domains. Methods: Individuals were recruited via the web using Google and Facebook advertisements. Enrolled participants were randomized into either active intervention or waitlist control groups. Participants completed the Beck Depression Inventory-Second Edition (BDI-II), Generalized Anxiety Disorder-7 (GAD-7), Hamilton Program for Schizophrenia Voices, Green Paranoid Thought Scale, Recovery Assessment Scale (RAS), Rosenberg Self-Esteem Scale (RSES), Friendship Scale, and Sheehan Disability Scale (SDS) at baseline (T1), 30-day (T2), and 60-day (T3) assessment points. Participants in the active group used CORE from T1 to T2, and participants in the waitlist group used CORE from T2 to T3. Both groups completed usability and accessibility measures after they concluded their intervention periods. Results: Overall, 315 individuals from 45 states participated in this study. The sample comprised individuals with self-reported bipolar disorder (111/315, 35.2%), major depressive disorder (136/315, 43.2%), and schizophrenia or schizoaffective disorder (68/315, 21.6%) who displayed moderate to severe symptoms and disability levels at baseline. Participants rated CORE as highly usable and acceptable. Intent-to-treat analyses showed significant treatment×time interactions for the BDI-II (F1,313=13.38; P<.001), GAD-7 (F1,313=5.87; P=.01), RAS (F1,313=23.42; P<.001), RSES (F1,313=19.28; P<.001), and SDS (F1,313=10.73; P=.001). Large effects were observed for the BDI-II (d=0.58), RAS (d=0.61), and RSES (d=0.64); a moderate effect size was observed for the SDS (d=0.44), and a small effect size was observed for the GAD-7 (d=0.20). Similar changes in outcome measures were later observed in the waitlist control group participants following crossover after they received CORE (T2 to T3). Approximately 41.5% (64/154) of participants in the active group and 60.2% (97/161) of participants in the waitlist group were retained at T2, and 33.1% (51/154) of participants in the active group and 40.3% (65/161) of participants in the waitlist group were retained at T3. Conclusions: We successfully recruited, screened, randomized, treated, and assessed a geographically dispersed sample of participants with SMI entirely via the web, demonstrating that fully remote clinical trials are feasible in this population; however, study retention remains challenging. CORE showed promise as a usable, acceptable, and effective tool for reducing the severity of psychiatric symptoms and disability while improving recovery and self-esteem. Rapid adoption and real-world dissemination of evidence-based mobile health interventions such as CORE are needed if we are to shorten the science-to-service gap and address the significant unmet mental health needs of people with SMI during the COVID-19 pandemic and beyond. Trial Registration: ClinicalTrials.gov NCT04068467; https://clinicaltrials.gov/ct2/show/NCT04068467 %M 34766913 %R 10.2196/29201 %U https://www.jmir.org/2021/11/e29201 %U https://doi.org/10.2196/29201 %U http://www.ncbi.nlm.nih.gov/pubmed/34766913 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 11 %P e28024 %T Improvements in Diet and Physical Activity–Related Psychosocial Factors Among African Americans Using a Mobile Health Lifestyle Intervention to Promote Cardiovascular Health: The FAITH! (Fostering African American Improvement in Total Health) App Pilot Study %A Cyriac,Jissy %A Jenkins,Sarah %A Patten,Christi A %A Hayes,Sharonne N %A Jones,Clarence %A Cooper,Lisa A %A Brewer,LaPrincess C %+ Department of Cardiovascular Medicine, Mayo Clinic College of Medicine, 200 First St. SW, Rochester, MN, 55905, United States, 1 507 266 1376, brewer.laprincess@mayo.edu %K African Americans %K cardiovascular health disparities %K mHealth lifestyle intervention %K diet %K physical activity %K mobile phone %D 2021 %7 12.11.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: African Americans continue to have suboptimal cardiovascular health (CVH) related to diet and physical activity (PA) behaviors compared with White people. Mobile health (mHealth) interventions are innovative platforms to improve diet and PA and have the potential to mitigate these disparities. However, these are understudied among African Americans. Objective: This study aims to examine whether an mHealth lifestyle intervention is associated with improved diet and PA-related psychosocial factors in African Americans and whether these changes correlate with diet and PA behavioral change. Methods: This study is a retrospective analysis evaluating changes in diet and PA-related self-regulation, social support, perceived barriers, and CVH behaviors (daily fruit and vegetable intake and moderate-intensity PA [MPA] per week) in 45 African American adults (mean age 48.7 years, SD 12.9 years; 33/45, 73% women) enrolled in the FAITH! (Fostering African American Improvement in Total Health) app pilot study. The intervention is a 10-week, behavioral theory–informed, community-based mHealth lifestyle intervention delivered through a mobile app platform. Participants engaged with 3 core FAITH! app features: multimedia education modules focused on CVH with self-assessments of CVH knowledge, self-monitoring of daily fruit and vegetable intake and PA, and a sharing board for social networking. Changes in self-reported diet and PA-related self-regulation, social support, perceived barriers, and CVH behaviors were assessed by electronic surveys collected at baseline and 28 weeks postintervention. Changes in diet and PA-related psychosocial factors from pre- to postintervention were assessed using paired 2-tailed t tests. The association of changes in diet and PA-related psychosocial variables with daily fruit and vegetable intake and MPA per week was assessed using Spearman correlation. Associations between baseline and 28-week postintervention changes in diet and PA-related psychosocial measures and CVH behaviors with covariates were assessed by multivariable linear regression. Results: Participants reported improvements in 2 subscales of diet self-regulation (decrease fat and calorie intake, P=.01 and nutrition tracking, P<.001), one subscale of social support for healthy diet (friend discouragement, P=.001), perceived barriers to healthy diet (P<.001), and daily fruit and vegetable intake (P<.001). Improvements in diet self-regulation (increase fruit, vegetable, and grain intake, and nutrition tracking) and social support for healthy diet (friend encouragement) had moderate positive correlations with daily fruit and vegetable intake (r=0.46, r=0.34, and r=0.43, respectively). A moderate negative correlation was observed between perceived barriers to healthy diet and daily fruit and vegetable intake (r=−0.25). Participants reported increases in PA self-regulation (P<.001). Increase in social support subscales for PA (family and friend participation) had a moderate positive correlation with MPA per week (r=0.51 and r=0.61, respectively). Conclusions: Our findings highlight key diet and PA-related psychosocial factors to target in future mHealth lifestyle interventions aimed at promoting CVH in African Americans. %M 34766917 %R 10.2196/28024 %U https://mhealth.jmir.org/2021/11/e28024 %U https://doi.org/10.2196/28024 %U http://www.ncbi.nlm.nih.gov/pubmed/34766917 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 11 %P e30332 %T Experiences of Wearable Technology by Persons with Knee Osteoarthritis Participating in a Physical Activity Counseling Intervention: Qualitative Study Using a Relational Ethics Lens %A Leese,Jenny %A MacDonald,Graham %A Backman,Catherine L %A Townsend,Anne %A Nimmon,Laura %A Li,Linda C %+ Faculty of Medicine, The University of British Columbia, Vancouver, BC, Canada, 1 604 207 4020, lli@arthritisresearch.ca %K relational ethics %K physical activity %K wearable %K arthritis %K qualitative %D 2021 %7 12.11.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Current evidence indicates physical activity wearables could support persons with knee osteoarthritis (OA) to be more physically active. However, recent evidence also identifies some persons with arthritis experience guilt or worry while using a wearable if they are not as active as they feel they should be. Questions remain around how persons with knee OA experience benefits or downsides using a wearable in their everyday lives. Better understanding is needed if wearables are to be incorporated in arthritis self-management in ethically aware ways. Objective: Using an ethics lens, we aimed to describe a range of experiences from persons with knee OA who used a wearable during a physical activity counseling intervention study. Methods: This is a secondary analysis of qualitative interviews nested within a randomized controlled trial. Guided by phenomenography, we explored the experiences of persons with knee OA following participation in a physical activity counseling intervention that involved using a Fitbit Flex and biweekly phone calls with a study physiotherapist (PT) in an 8-week period. Benefits or downsides experienced in participants’ relationships with themselves or the study PT when using the wearable were identified using a relational ethics lens. Results: Interviews with 21 participants (12 females and 9 males) aged 40 to 82 years were analyzed. Education levels ranged from high school graduates (4/21, 19%) to bachelor’s degrees or above (11/21, 52%). We identified 3 categories of description: (1) participants experienced their wearable as a motivating or nagging influence to be more active, depending on how freely they were able to make autonomous choices about physical activity in their everyday lives; (2) some participants felt a sense of accomplishment from seeing progress in their wearable data, which fueled their motivation; (3) for some participants, sharing wearable data helped to build mutual trust in their relationship with the study PT. However, they also expressed there was potential for sharing wearable data to undermine this trust, particularly if this data was inaccurate. Conclusions: Findings provide an early glimpse into positive and negative emotional impacts of using a wearable that can be experienced by participants with knee OA when participating in a randomized controlled trial to support physical activity. To our knowledge, this is the first qualitative study that uses a relational ethics lens to explore how persons with arthritis experienced changes in their relationship with a health professional when using a wearable during research participation. %M 34766912 %R 10.2196/30332 %U https://mhealth.jmir.org/2021/11/e30332 %U https://doi.org/10.2196/30332 %U http://www.ncbi.nlm.nih.gov/pubmed/34766912 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 11 %P e26221 %T Dropout From an Internet-Delivered Cognitive Behavioral Therapy Intervention for Adults With Depression and Anxiety: Qualitative Study %A Lawler,Kate %A Earley,Caroline %A Timulak,Ladislav %A Enrique,Angel %A Richards,Derek %+ E-Mental Health Research Group, School of Psychology, Trinity College Dublin, College Green, Dublin, Ireland, 353 851510008, lawlerka@tcd.ie %K depression %K anxiety %K iCBT %K dropout %K internet interventions %D 2021 %7 12.11.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Treatment dropout continues to be reported from internet-delivered cognitive behavioral therapy (iCBT) interventions, and lower completion rates are generally associated with lower treatment effect sizes. However, evidence is emerging to suggest that completion of a predefined number of modules is not always necessary for clinical benefit or consideration of the needs of each individual patient. Objective: The aim of this study is to perform a qualitative analysis of patients’ experiences with an iCBT intervention in a routine care setting to achieve a deeper insight into the phenomenon of dropout. Methods: A total of 15 purposively sampled participants (female: 8/15, 53%) from a larger parent randomized controlled trial were interviewed via telephone using a semistructured interview schedule that was developed based on the existing literature and research on dropout in iCBT. Data were analyzed using a descriptive-interpretive approach. Results: The experience of treatment leading to dropout can be understood in terms of 10 domains: relationship to technology, motivation to start, background knowledge and attitudes toward iCBT, perceived change in motivation, usage of the program, changes due to the intervention, engagement with content, experience interacting with the supporter, experience of web-based communication, and termination of the supported period. Conclusions: Patients who drop out of treatment can be distinguished in terms of their change in motivation: those who felt ready to leave treatment early and those who had negative reasons for dropping out. These 2 groups of participants have different treatment experiences, revealing the potential attributes and nonattributes of dropout. The reported between-group differences should be examined further to consider those attributes that are strongly descriptive of the experience and regarded less important than those that have become loosely affiliated. %M 34766909 %R 10.2196/26221 %U https://formative.jmir.org/2021/11/e26221 %U https://doi.org/10.2196/26221 %U http://www.ncbi.nlm.nih.gov/pubmed/34766909 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e22369 %T Remote Digital Psychiatry for Mobile Mental Health Assessment and Therapy: MindLogger Platform Development Study %A Klein,Arno %A Clucas,Jon %A Krishnakumar,Anirudh %A Ghosh,Satrajit S %A Van Auken,Wilhelm %A Thonet,Benjamin %A Sabram,Ihor %A Acuna,Nino %A Keshavan,Anisha %A Rossiter,Henry %A Xiao,Yao %A Semenuta,Sergey %A Badioli,Alessandra %A Konishcheva,Kseniia %A Abraham,Sanu Ann %A Alexander,Lindsay M %A Merikangas,Kathleen R %A Swendsen,Joel %A Lindner,Ariel B %A Milham,Michael P %+ MATTER Lab, Child Mind Institute, 101 East 56th Street, New York, NY, 10022, United States, 1 347 577 2091, arno@childmind.org %K mental health %K mHealth %K mobile health %K digital health %K eHealth %K digital psychiatry %K digital phenotyping %K teletherapy %K mobile device %K mobile phone %K smartphone %K ecological momentary assessment %K ecological momentary intervention %K EMA %K EMI %K ESM %K experience sampling %K experience sampling methods %D 2021 %7 11.11.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Universal access to assessment and treatment of mental health and learning disorders remains a significant and unmet need. There are many people without access to care because of economic, geographic, and cultural barriers, as well as the limited availability of clinical experts who could help advance our understanding and treatment of mental health. Objective: This study aims to create an open, configurable software platform to build clinical measures, mobile assessments, tasks, and interventions without programming expertise. Specifically, our primary requirements include an administrator interface for creating and scheduling recurring and customized questionnaires where end users receive and respond to scheduled notifications via an iOS or Android app on a mobile device. Such a platform would help relieve overwhelmed health systems and empower remote and disadvantaged subgroups in need of accurate and effective information, assessment, and care. This platform has the potential to advance scientific research by supporting the collection of data with instruments tailored to specific scientific questions from large, distributed, and diverse populations. Methods: We searched for products that satisfy these requirements. We designed and developed a new software platform called MindLogger, which exceeds the requirements. To demonstrate the platform’s configurability, we built multiple applets (collections of activities) within the MindLogger mobile app and deployed several of them, including a comprehensive set of assessments underway in a large-scale, longitudinal mental health study. Results: Of the hundreds of products we researched, we found 10 that met our primary requirements with 4 that support end-to-end encryption, 2 that enable restricted access to individual users’ data, 1 that provides open-source software, and none that satisfy all three. We compared features related to information presentation and data capture capabilities; privacy and security; and access to the product, code, and data. We successfully built MindLogger mobile and web applications, as well as web browser–based tools for building and editing new applets and for administering them to end users. MindLogger has end-to-end encryption, enables restricted access, is open source, and supports a variety of data collection features. One applet is currently collecting data from children and adolescents in our mental health study, and other applets are in different stages of testing and deployment for use in clinical and research settings. Conclusions: We demonstrated the flexibility and applicability of the MindLogger platform through its deployment in a large-scale, longitudinal, mobile mental health study and by building a variety of other mental health–related applets. With this release, we encourage a broad range of users to apply the MindLogger platform to create and test applets to advance health care and scientific research. We hope that increasing the availability of applets designed to assess and administer interventions will facilitate access to health care in the general population. %M 34762054 %R 10.2196/22369 %U https://www.jmir.org/2021/11/e22369 %U https://doi.org/10.2196/22369 %U http://www.ncbi.nlm.nih.gov/pubmed/34762054 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 11 %P e30435 %T Public Perceptions of Diabetes, Healthy Living, and Conversational Agents in Singapore: Needs Assessment %A Dhinagaran,Dhakshenya Ardhithy %A Sathish,Thirunavukkarasu %A Kowatsch,Tobias %A Griva,Konstadina %A Best,James Donovan %A Tudor Car,Lorainne %+ Lee Kong Chian School of Medicine, Nanyang Technological University Singapore, Clinical Sciences Building, 11 Mandalay Road, Singapore, 308232, Singapore, 65 69041258, lorainne.tudor.car@ntu.edu.sg %K conversational agents %K chatbots %K diabetes %K prediabetes %K healthy lifestyle change %K mobile phone %D 2021 %7 11.11.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: The incidence of chronic diseases such as type 2 diabetes is increasing in countries worldwide, including Singapore. Health professional–delivered healthy lifestyle interventions have been shown to prevent type 2 diabetes. However, ongoing personalized guidance from health professionals is not feasible or affordable at the population level. Novel digital interventions delivered using mobile technology, such as conversational agents, are a potential alternative for the delivery of healthy lifestyle change behavioral interventions to the public. Objective: We explored perceptions and experiences of Singaporeans on healthy living, diabetes, and mobile health (mHealth) interventions (apps and conversational agents). This study was conducted to help inform the design and development of a conversational agent focusing on healthy lifestyle changes. Methods: This qualitative study was conducted in August and September 2019. A total of 20 participants were recruited from relevant healthy living Facebook pages and groups. Semistructured interviews were conducted in person or over the telephone using an interview guide. Interviews were transcribed and analyzed in parallel by 2 researchers using Burnard’s method, a structured approach for thematic content analysis. Results: The collected data were organized into 4 main themes: use of conversational agents, ubiquity of smartphone apps, understanding of diabetes, and barriers and facilitators to a healthy living in Singapore. Most participants used health-related mobile apps as well as conversational agents unrelated to health care. They provided diverse suggestions for future conversational agent-delivered interventions. Participants also highlighted several knowledge gaps in relation to diabetes and healthy living. Regarding barriers to healthy living, participants mentioned frequent dining out, high stress levels, lack of work-life balance, and lack of free time to engage in physical activity. In contrast, discipline, preplanning, and sticking to a routine were important for enabling a healthy lifestyle. Conclusions: Participants in this study commonly used mHealth interventions and provided important insights into their knowledge gaps and needs in relation to changes in healthy lifestyle behaviors. Future digital interventions such as conversational agents focusing on healthy lifestyle and diabetes prevention should aim to address the barriers highlighted in our study and motivate individuals to adopt healthy lifestyle behavior. %M 34762053 %R 10.2196/30435 %U https://formative.jmir.org/2021/11/e30435 %U https://doi.org/10.2196/30435 %U http://www.ncbi.nlm.nih.gov/pubmed/34762053 %0 Journal Article %@ 2291-9694 %I JMIR Publications %V 9 %N 11 %P e28090 %T Toward Personalized Web-Based Cognitive Rehabilitation for Patients With Ischemic Stroke: Elo Rating Approach %A Garcia-Rudolph,Alejandro %A Opisso,Eloy %A Tormos,Jose M %A Madai,Vince Istvan %A Frey,Dietmar %A Becerra,Helard %A Kelleher,John D %A Bernabeu Guitart,Montserrat %A López,Jaume %+ Institut Guttmann Hospital de Neurorehabilitacio, Cami de Can Ruti s/n, Badalona, Spain, 34 934 97 77 00, alejandropablogarcia@gmail.com %K cognitive rehabilitation %K Elo rating %K predictors %K stroke rehabilitation %K web-based tasks %D 2021 %7 10.11.2021 %9 Original Paper %J JMIR Med Inform %G English %X Background: Stroke is a worldwide cause of disability; 40% of stroke survivors sustain cognitive impairments, most of them following inpatient rehabilitation at specialized clinical centers. Web-based cognitive rehabilitation tasks are extensively used in clinical settings. The impact of task execution depends on the ratio between the skills of the treated patient and the challenges imposed by the task itself. Thus, treatment personalization requires a trade-off between patients’ skills and task difficulties, which is still an open issue. In this study, we propose Elo ratings to support clinicians in tasks assignations and representing patients’ skills to optimize rehabilitation outcomes. Objective: This study aims to stratify patients with ischemic stroke at an early stage of rehabilitation into three levels according to their Elo rating; to show the relationships between the Elo rating levels, task difficulty levels, and rehabilitation outcomes; and to determine if the Elo rating obtained at early stages of rehabilitation is a significant predictor of rehabilitation outcomes. Methods: The PlayerRatings R library was used to obtain the Elo rating for each patient. Working memory was assessed using the DIGITS subtest of the Barcelona test, and the Rey Auditory Verbal Memory Test (RAVLT) was used to assess verbal memory. Three subtests of RAVLT were used: RAVLT learning (RAVLT075), free-recall memory (RAVLT015), and recognition (RAVLT015R). Memory predictors were identified using forward stepwise selection to add covariates to the models, which were evaluated by assessing discrimination using the area under the receiver operating characteristic curve (AUC) for logistic regressions and adjusted R2 for linear regressions. Results: Three Elo levels (low, middle, and high) with the same number of patients (n=96) in each Elo group were obtained using the 50 initial task executions (from a total of 38,177) for N=288 adult patients consecutively admitted for inpatient rehabilitation in a clinical setting. The mid-Elo level showed the highest proportions of patients that improved in all four memory items: 56% (54/96) of them improved in DIGITS, 67% (64/96) in RAVLT075, 58% (56/96) in RAVLT015, and 53% (51/96) in RAVLT015R (P<.001). The proportions of patients from the mid-Elo level that performed tasks at difficulty levels 1, 2, and 3 were 32.1% (3997/12,449), 31.% (3997/12,449), and 36.9% (4595/12,449), respectively (P<.001), showing the highest match between skills (represented by Elo level) and task difficulties, considering the set of 38,177 task executions. Elo ratings were significant predictors in three of the four models and quasi-significant in the fourth. When predicting RAVLT075 and DIGITS at discharge, we obtained R2=0.54 and 0.43, respectively; meanwhile, we obtained AUC=0.73 (95% CI 0.64-0.82) and AUC=0.81 (95% CI 0.72-0.89) in RAVLT075 and DIGITS improvement predictions, respectively. Conclusions: Elo ratings can support clinicians in early rehabilitation stages in identifying cognitive profiles to be used for assigning task difficulty levels. %M 34757325 %R 10.2196/28090 %U https://medinform.jmir.org/2021/11/e28090 %U https://doi.org/10.2196/28090 %U http://www.ncbi.nlm.nih.gov/pubmed/34757325 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 11 %P e30313 %T Development of a Severity Score and Comparison With Validated Measures for Depression and Anxiety: Validation Study %A Lynch,William %A Platt,Michael L %A Pardes,Adam %+ NeuroFlow, Inc, 111 S Independence Mall E, Suite 701, Philadelphia, PA, United States, 1 267 671 7316, adam@neuroflow.com %K PHQ-9 %K GAD-7 %K depression assessment %K anxiety assessment %K measurement-based care %K integrated behavioral health %D 2021 %7 10.11.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Less than 10% of the individuals seeking behavioral health care receive measurement-based care (MBC). Technology has the potential to implement MBC in a secure and efficient manner. To test this idea, a mobile health (mHealth) platform was developed with the goal of making MBC easier to deliver by clinicians and more accessible to patients within integrated behavioral health care. Data from over 3000 users of the mHealth platform were used to develop an output severity score, a robust screening measure for depression and anxiety. Objective: The aim of this study is to compare severity scores with scores from validated assessments for depression and anxiety and scores from clinician review to evaluate the potential added value of this new measure. Methods: The severity score uses patient-reported and passively collected data related to behavioral health on an mHealth platform. An artificial intelligence–derived algorithm was developed that condenses behavioral health data into a single, quantifiable measure for longitudinal tracking of an individual’s depression and anxiety symptoms. Linear regression and Bland-Altman analyses were used to evaluate the relationships and differences between severity scores and Personal Health Questionnaire-9 (PHQ-9) or Generalized Anxiety Disorder-7 (GAD-7) scores from over 35,000 mHealth platform users. The severity score was also compared with a review by a panel of expert clinicians for a subset of 250 individuals. Results: Linear regression results showed a strong correlation between the severity score and PHQ-9 (r=0.74; P<.001) and GAD-7 (r=0.80; P<.001) changes. A strong positive correlation was also found between the severity score and expert panel clinical review (r=0.80-0.84; P<.001). However, Bland-Altman analysis and the evaluation of outliers on regression analysis showed that the severity score was significantly different from the PHQ-9. Conclusions: Clinicians can reliably use the mHealth severity score as a proxy measure for screening and monitoring behavioral health symptoms longitudinally. The severity score may identify at-risk individuals who are not identified by the PHQ-9. Further research is warranted to evaluate the sensitivity and specificity of the severity score. %M 34757319 %R 10.2196/30313 %U https://formative.jmir.org/2021/11/e30313 %U https://doi.org/10.2196/30313 %U http://www.ncbi.nlm.nih.gov/pubmed/34757319 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e27897 %T Mediating Effects of Stigma and Depressive Symptoms in a Social Media–Based Intervention to Improve Long-term Quality of Life Among People Living With HIV: Secondary Analysis of a Randomized Controlled Trial %A Li,Yiran %A Guo,Yan %A Hong,Y Alicia %A Zeng,Chengbo %A Zeng,Yu %A Zhang,Hanxi %A Zhu,Mengting %A Qiao,Jiaying %A Cai,Weiping %A Li,Linghua %A Liu,Cong %+ Department of Medical Statistics, School of Public Health, Sun Yat-sen University, #74 2nd Zhongshan Road, Guangzhou, 510080, China, 86 020 87334202, guoy8@mail.sysu.edu.cn %K mHealth %K HIV %K depressive symptoms %K quality of life %K structural equation model %D 2021 %7 9.11.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Mobile health (mHealth) interventions have been shown to effectively improve the quality of life (QOL) among people living with HIV. However, little is known about the long-term effects of mHealth interventions. Objective: This study aims to explore the intervention mechanisms of a social media–based intervention, Run4Love, on the QOL of people with HIV over across a 9-month follow-up period. Methods: We recruited people living with HIV who were concurrently experiencing elevated depressive symptoms from an HIV outpatient clinic in South China. A total of 300 eligible participants were randomized either to the intervention group or the control group in a 1:1 ratio after they provided informed consent and completed a baseline survey. The intervention group received a 3-month WeChat-based intervention, comprising cognitive-behavioral stress management (CBSM) courses and physical activity promotion. The control group received a printed brochure on nutrition guidelines in addition to the usual care for HIV treatment. Neither participants nor the research staff were blinded to group assignment. All patients were followed at 3, 6, and 9 months. The primary outcome was depressive symptoms. Structural equation model (SEM) with longitudinal data was conducted to examine the sequential mediating effects of HIV-related stigma and depressive symptoms on the long-term intervention effects on participants’ QOL. Results: About 91.3% (274/300), 88.3% (265/300), and 86.7% (260/300) of all participants completed follow-up surveys at 3, 6, and 9 months, respectively. Results showed that the intervention had significantly improved participants' QOL at 9 months, via complete mediating effects of reduced HIV-related stigma at 3 months and decreased depressive symptoms at 6 months. No adverse events were reported. Conclusions: These findings underscore the critical roles of HIV-related stigma and depressive symptoms in an mHealth intervention with long-term effects on QOL improvements. We call for targeted mHealth interventions to improve QOL among people living with HIV, especially social media–based interventions that can address HIV-related stigma and alleviate depressive symptoms. Trial Registration: Chinese Clinical Trial Registry ChiCTR-IPR-17012606; https://www.chictr.org.cn/showproj.aspx?proj=21019 %M 34751654 %R 10.2196/27897 %U https://www.jmir.org/2021/11/e27897 %U https://doi.org/10.2196/27897 %U http://www.ncbi.nlm.nih.gov/pubmed/34751654 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 11 %P e32847 %T Mechanisms of Smartphone Apps for Cigarette Smoking Cessation: Results of a Serial Mediation Model From the iCanQuit Randomized Trial %A Bricker,Jonathan B %A Levin,Michael %A Lappalainen,Raimo %A Mull,Kristin %A Sullivan,Brianna %A Santiago-Torres,Margarita %+ Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, M3-B232, Seattle, WA, 98109, United States, 1 2066675074, jbricker@fredhutch.org %K mediation %K engagement %K digital %K mHealth: smartphone %K acceptance %K smoking %K cessation %K app %K randomized controlled trial %K model %K intervention %D 2021 %7 9.11.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Engagement with digital interventions is a well-known predictor of treatment outcomes, but this knowledge has had limited actionable value. Instead, learning why engagement with digital interventions impact treatment outcomes can lead to targeted improvements in their efficacy. Objective: This study aimed to test a serial mediation model of an Acceptance and Commitment Therapy (ACT) smartphone intervention for smoking cessation. Methods: In this randomized controlled trial, participants (N=2415) from 50 US states were assigned to the ACT-based smartphone intervention (iCanQuit) or comparison smartphone intervention (QuitGuide). Their engagement with the apps (primary measure: number of logins) was measured during the first 3 months, ACT processes were measured at baseline and 3 months (acceptance of internal cues to smoke, valued living), and smoking cessation was measured at 12 months with 87% follow-up retention. Results: There was a significant serial mediation effect of iCanQuit on smoking cessation through multiple indicators of intervention engagement (ie, total number of logins, total number of minutes used, and total number of unique days of use) and in turn through increases in mean acceptance of internal cues to smoke from baseline to 3 months. Analyses of the acceptance subscales showed that the mediation was through acceptance of physical sensations and emotions, but not acceptance of thoughts. There was no evidence that the effect of the iCanQuit intervention was mediated through changes in valued living. Conclusions: In this first study of serial mediators underlying the efficacy of smartphone apps for smoking cessation, our results suggest the effect of the iCanQuit ACT-based smartphone app on smoking cessation was mediated through multiple indicators of engagement and in turn through increases in the acceptance of physical sensations and emotions that cue smoking. Trial Registration: Clinical Trials.gov NCT02724462; https://clinicaltrials.gov/ct2/show/NCT02724462 %M 34751662 %R 10.2196/32847 %U https://mhealth.jmir.org/2021/11/e32847 %U https://doi.org/10.2196/32847 %U http://www.ncbi.nlm.nih.gov/pubmed/34751662 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 11 %P e18969 %T Exploring the Barriers to and Motivators for Using Digital Mental Health Interventions Among Construction Personnel in Nigeria: Qualitative Study %A Nwaogu,Janet Mayowa %A Chan,Albert P C %A Naslund,John A %A Hon,Carol K H %A Belonwu,Christopher %A Yang,Jackie %+ Department of Building and Real Estate, The Hong Kong Polytechnic University, Kowloon, Hong Kong, 852 52243597, janet.nwaogu@connect.polyu.hk %K mental health %K construction personnel %K digital technology %K digital intervention %K barriers %K motivators %K mobile phone %D 2021 %7 9.11.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Work-related stress in the construction industry increases the prevalence of depression and anxiety among personnel. In low-resource settings such as Nigeria, construction personnel face high demands and severe working conditions but only have a few services to address their mental health needs. With emerging research showing that digital interventions can be used to self-manage mental health across diverse settings, there may be new opportunities to support construction personnel in the construction industry. Objective: This study aims to determine the use of digital interventions for mental health management among construction personnel in Nigeria and to explore the factors that facilitate or impede the use of these interventions. Methods: This qualitative study explored the perspectives of a convenience sample of 62 construction personnel. The data were subjected to inductive content analysis. Results: A total of 6 barrier and 3 motivator themes were identified and categorized into 2 groups. The barrier themes were subcategorized into barriers to adoption and barriers to persistent use, whereas the motivator themes were subcategorized into intrinsic and extrinsic motivators. Lack of awareness and knowledge about the interventions may constitute a barrier to adoption and use. Participants frequently reported concerns regarding their effectiveness and usability. Conclusions: This study provides an understanding of the design needs required to facilitate sustained self-management of mental health based on the experiences and expectations of construction personnel with digital interventions. %M 34751652 %R 10.2196/18969 %U https://formative.jmir.org/2021/11/e18969 %U https://doi.org/10.2196/18969 %U http://www.ncbi.nlm.nih.gov/pubmed/34751652 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 11 %P e31170 %T Mobile Apps That Promote Emotion Regulation, Positive Mental Health, and Well-being in the General Population: Systematic Review and Meta-analysis %A Eisenstadt,Mia %A Liverpool,Shaun %A Infanti,Elisa %A Ciuvat,Roberta Maria %A Carlsson,Courtney %+ Evidence Based Practice Unit, Anna Freud National Centre for Children and Families and University College London, 4-8 Rodney Street, London, N1 9JH, United Kingdom, 44 7989165986, mia.eisenstadt@annafreud.org %K systematic review %K MHapp, mHealth %K mental health %K well-being %K emotion regulation %K mobile apps %K effectiveness %K monitoring %K management %K mental health app %D 2021 %7 8.11.2021 %9 Review %J JMIR Ment Health %G English %X Background: Among the general public, there appears to be a growing need and interest in receiving digital mental health and well-being support. In response to this, mental health apps (MHapps) are becoming available for monitoring, managing, and promoting positive mental health and well-being. Thus far, evidence supports favorable outcomes when users engage with MHapps, yet there is a relative paucity of reviews on apps that support positive mental health and well-being. Objective: We aimed to systematically review the available research on MHapps that promote emotion regulation, positive mental health, and well-being in the general population aged 18-45 years. More specifically, the review aimed at providing a systematic description of the theoretical background and features of MHapps while evaluating any potential effectiveness. Methods: A comprehensive literature search of key databases, including MEDLINE (via Ovid), EMBASE (via Ovid), PsycINFO (via Ovid), Web of Science, and the Cochrane Register of Controlled Trials (CENTRAL), was performed until January 2021. Studies were included if they described standalone mental health and well-being apps for adults without a formal mental health diagnosis. The quality of all studies was assessed against the Mixed Methods Appraisal Tool. In addition, the Cochrane Risk-of-Bias tool (RoB-2) was used to assess randomized control trials (RCTs). Data were extracted using a modified extraction form from the Cochrane Handbook of Systematic Reviews. A narrative synthesis and meta-analysis were then undertaken to address the review aims. Results: In total, 3156 abstracts were identified. Of these, 52 publications describing 48 MHapps met the inclusion criteria. Together, the studies evaluated interventions across 15 countries. Thirty-nine RCTs were identified suggesting some support for the role of individual MHapps in improving and promoting mental health and well-being. Regarding the pooled effect, MHapps, when compared to controls, showed a small effect for reducing mental health symptoms (k=19, Hedges g=–0.24, 95% CI –0.34 to –0.14; P<.001) and improving well-being (k=13, g=0.17, 95% CI 0.05-0.29, P=.004), and a medium effect for emotion regulation (k=6, g=0.49, 95% CI 0.23-0.74, P<.001). There is also a wide knowledge base of creative and innovative ways to engage users in techniques such as mood monitoring and guided exercises. Studies were generally assessed to contribute unclear or a high risk of bias, or to be of medium to low methodological quality. Conclusions: The emerging evidence for MHapps that promote positive mental health and well-being suggests promising outcomes. Despite a wide range of MHapps, few apps specifically promote emotion regulation. However, our findings may position emotion regulation as an important mechanism for inclusion in future MHapps. A fair proportion of the included studies were pilot or feasibility trials (k=17, 33%), and full-scale RCTs reported high attrition rates and nondiverse samples. Given the number and pace at which MHapps are being released, further robust research is warranted to inform the development and testing of evidence-based programs. %M 34747713 %R 10.2196/31170 %U https://mental.jmir.org/2021/11/e31170 %U https://doi.org/10.2196/31170 %U http://www.ncbi.nlm.nih.gov/pubmed/34747713 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 11 %P e30622 %T The Relationship Between Weight Loss Outcomes and Engagement in a Mobile Behavioral Change Intervention: Retrospective Analysis %A Carey,Alissa %A Yang,Qiuchen %A DeLuca,Laura %A Toro-Ramos,Tatiana %A Kim,Youngin %A Michaelides,Andreas %+ Academic Research, Noom Inc, Fl 9, 229 W 28th St, New York, NY, 10001, United States, 1 631 938 1248, andreas@noom.com %K engagement %K mHealth %K obesity %K weight management %K Noom %K application %K app %K behavioral change %K digital behavior change interventions %D 2021 %7 8.11.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: There is large variance in weight loss outcomes of digital behavior change interventions (DBCIs). It has been suggested that different patterns of engagement in the program could be responsible for this variance in outcomes. Previous studies have found that the amount of engagement on DBCIs, such as the number of meals logged or articles read, is positively associated with weight loss. Objective: This retrospective study extends previous research by observing how important weight loss outcomes (high weight loss: 10% or greater body weight loss; moderate weight loss: between 5% to 10%; stable weight: 0 plus or minus 1%) are associated with engagement on a publicly available mobile DBCI (Noom) from 9 to 52 weeks. Methods: Engagement and weight data for eligible participants (N=11,252) were extracted from the Noom database. Engagement measures included the number of articles read, meals logged, steps recorded, messages to coach, exercise logged, weigh-ins, and days with 1 meal logged per week. Weight was self-reported on the program. Multiple linear regressions examined how weight loss outcome (moderate and high vs stable) was associated with each engagement measure across 3 study time periods: 9-16 weeks, 17-32 weeks, and 33-52 weeks. Results: At 9-16 weeks, among the 11,252 participants, 2594 (23.05%) had stable weight, 6440 (57.23%) had moderate weight loss, and 2218 (19.71%) had high weight loss. By 33-52 weeks, 525 (18.21%) had stable weight, 1214 (42.11%) had moderate weight loss, and 1144 (39.68%) had high weight loss. Regression results showed that moderate weight loss and high weight loss outcomes were associated with all engagement measures to a significantly greater degree than was stable weight (all P values <.001). These differences held across all time periods with the exception of exercise for the moderate weight loss category at 1 time period of 33-52 weeks. Exercise logging increased from 9 to 52 weeks regardless of the weight loss group. Conclusions: Our results suggest that these clinically important weight loss outcomes are related to the number of articles read, meals logged, steps recorded, messages to coach, exercise logged, weigh-ins, and days with 1 meal logged per week both in the short-term and long-term (ie, 1 year) on Noom. This provides valuable data on engagement patterns over time on a self-directed mobile DBCI, can help inform how interventions tailor recommendations for engagement depending on how much weight individuals have lost, and raises important questions for future research on engagement in DBCIs. %M 34747706 %R 10.2196/30622 %U https://mhealth.jmir.org/2021/11/e30622 %U https://doi.org/10.2196/30622 %U http://www.ncbi.nlm.nih.gov/pubmed/34747706 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 9 %N 4 %P e29044 %T Feasibility of a Sensor-Controlled Digital Game for Heart Failure Self-management: Randomized Controlled Trial %A Radhakrishnan,Kavita %A Julien,Christine %A Baranowski,Tom %A O'Hair,Matthew %A Lee,Grace %A Sagna De Main,Atami %A Allen,Catherine %A Viswanathan,Bindu %A Thomaz,Edison %A Kim,Miyong %+ School of Nursing, The University of Texas Austin, 1710 Red River St, Austin, TX, 78701, United States, 1 512 471 7936, Kradhakrishnan@mail.nur.utexas.edu %K heart failure %K digital game %K sensor %K self-management %K older adults %K weight monitoring %K physical activity %K behaviors %K mobile phone %D 2021 %7 8.11.2021 %9 Original Paper %J JMIR Serious Games %G English %X Background: Poor self-management of heart failure (HF) contributes to devastating health consequences. Our innovative sensor-controlled digital game (SCDG) integrates data from sensors to trigger game rewards, progress, and feedback based on the real-time behaviors of individuals with HF. Objective: The aim of this study is to compare daily weight monitoring and physical activity behavior adherence by older adults using an SCDG intervention versus a sensors-only intervention in a feasibility randomized controlled trial. Methods: English-speaking adults with HF aged 55 years or older who owned a smartphone and could walk unassisted were recruited from Texas and Oklahoma from November 2019 to August 2020. Both groups were given activity trackers and smart weighing scales to track behaviors for 12 weeks. The feasibility outcomes of recruitment, retention, intervention engagement, and satisfaction were assessed. In addition to daily weight monitoring and physical activity adherence, the participants’ knowledge, functional status, quality of life, self-reported HF behaviors, motivation to engage in behaviors, and HF-related hospitalization were also compared between the groups at baseline and at 6, 12, and 24 weeks. Results: A total of 38 participants with HF—intervention group (IG; 19/38, 50%) and control group (CG; 19/38, 50%)—were enrolled in the study. Of the 38 participants, 18 (47%) were women, 18 (47%) were aged 65 years or older, 21 (55%) had been hospitalized with HF in the past 6 months, and 29 (76%) were White. Furthermore, of these 38 participants, 31 (82%)—IG (15/19, 79%) and CG (16/19, 84%)—had both weight monitoring and physical activity data at the end of 12 weeks, and 27 (71%)—IG (14/19, 74%) and CG (13/19, 68%)—participated in follow-up assessments at 24 weeks. For the IG participants who installed the SCDG app (15/19, 79%), the number of days each player opened the game app was strongly associated with the number of days the player engaged in weight monitoring (r=0.72; P=.04) and the number of days with physical activity step data (r=0.9; P<.001). The IG participants who completed the satisfaction survey (13/19, 68%) reported that the SCDG was easy to use. Trends of improvement in daily weight monitoring and physical activity in the IG, as well as within-group improvements in HF functional status, quality of life, knowledge, self-efficacy, and HF hospitalization in both groups, were observed in this feasibility trial. Conclusions: Playing an SCDG on smartphones was feasible and acceptable for older adults with HF for motivating daily weight monitoring and physical activity. A larger efficacy trial of the SCDG intervention will be needed to validate trends of improvement in daily weight monitoring and physical activity behaviors. Trial Registration: ClinicalTrials.gov NCT03947983; https://clinicaltrials.gov/ct2/show/NCT03947983 %M 34747701 %R 10.2196/29044 %U https://games.jmir.org/2021/4/e29044 %U https://doi.org/10.2196/29044 %U http://www.ncbi.nlm.nih.gov/pubmed/34747701 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e28322 %T A Digital Self-management Program (Help to Overcome Problems Effectively) for People Living With Cancer: Feasibility Randomized Controlled Trial %A Wright,Hayley %A Martin,Faith %A Clyne,Wendy %A Clark,Cain C T %A Matouskova,Gabriela %A McGillion,Michael %A Turner,Andrew %+ Centre for Intelligent Healthcare, Research Institute for Health and Wellbeing, Coventry University, Priory Street, Coventry, CV1 5FB, United Kingdom, 44 7599782465, hsx116@coventry.ac.uk %K self-management %K cancer %K survivorship %K digital %K positive psychology %D 2021 %7 5.11.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: We present the results of a feasibility, randomized waitlist control group (CG) parallel design study with a 1:1 allocation ratio. Participants were randomized into an intervention group (IG) or a waitlist CG. The intervention was a 6-week digital self-management program, Help to Overcome Problems Effectively (HOPE), for people with cancer. Objective: This study aims to test the feasibility of a digitally delivered self-management program for people with cancer. This will inform the design of a definitive randomized controlled trial. In addition, a preliminary assessment of the impact of the HOPE program via secondary outcomes will be used to assess signals of efficacy in a trial context. Methods: Participants were drawn from an opportunity sample, referred by Macmillan Cancer Support, and were invited via email to participate in the study (N=61). Primary outcomes were rates of recruitment, retention, follow-up, completion and adherence, sample size and effect size estimation, and assessment of progression criteria for a definitive trial. Secondary outcomes were self-report measures of participants’ positive mental well-being, depression, anxiety, and patient activation (ie, confidence in managing their cancer). The intervention and data collection took place on the web. Results: The recruitment rate was 77% (47/61). A total of 41 participants completed the baseline questionnaires and were randomized to either the IG (n=21) or the waitlist CG (n=20). The retention rate (attending all program sessions) was greater than 50% (all: 21/41, 51%, IG: 10/21, 48%; and CG: 11/20, 55%). The follow-up rate (completing all questionnaires) was greater than 80% (all: 33/41, 80%; IG: 16/21, 76%; and CG: 17/20, 85%). The completion rate (attending ≥3 sessions and completing all questionnaires) was greater than 60% (all: 25/41, 61%; IG: 13/21, 62%; and CG: 12/20, 60%). Engagement data showed that participants viewed between half (5.1/10, 51%) and three-quarters (12.2/16, 76%) of the pages in each session. Conclusions: All progression criteria for a definitive trial were met, as supported by the primary outcome data. The IG showed improved postprogram scores on measures of positive mental well-being, depression, anxiety, and patient activation. A full-scale trial of the digital HOPE program for people with cancer will allow us to fully evaluate the efficacy of the intervention relative to a CG. Trial Registration: ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250 International Registered Report Identifier (IRRID): RR2-10.2196/24264 %M 34738912 %R 10.2196/28322 %U https://www.jmir.org/2021/11/e28322 %U https://doi.org/10.2196/28322 %U http://www.ncbi.nlm.nih.gov/pubmed/34738912 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e25159 %T The Sociological Perspective of Users’ Invisible Work: A Qualitative Research Framework for Studying Digital Health Innovations Integration %A Trupia,Dilara Vanessa %A Mathieu-Fritz,Alexandre %A Duong,Tu Anh %+ LATTS, Univ Gustave Eiffel, CNRS, Ecole des Ponts, 5 boulevard Descartes, Cité Descartes, Bâtiment Bois de l’Etang, Marne-la-Vallée, F-77454, France, 33 618635423, dilaratrupia@gmail.com %K digital health innovations %K qualitative analysis %K sociological framework %K invisible work %K patient work %K user work %K participatory health care %K chronic illness %K self-quantification %D 2021 %7 4.11.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: When new technology is integrated into a care pathway, it faces resistance due to the changes it introduces into the existing context. To understand the success or failure of digital health innovations, it is necessary to pay attention to the adjustments that users must perform to make them work, by reshaping the context and sometimes by altering the ways in which they perform activities. This adaptation work, most of which remains invisible, constitutes an important factor in the success of innovations and the ways in which they transform care practices. Objective: This work aims to present a sociological framework for studying new health technology uses through a qualitative analysis of the different types of tasks and activities that users, both health professionals and patients, must perform to integrate these technologies and make them work in their daily routine. Methods: This paper uses a three-part method to structure a theoretical model to study users’ invisible work. The first part of the method includes a thematic literature review, previously published by one of the coauthors, of major sociological studies conducted on digital health innovations integration into existing care organizations and practices. The second part extends this review to introduce definitions and applications of the users’ invisible work concept. The third part consists of producing a theoretical framework to study the concept according to the different contexts and practices of the users. Results: The paper proposes four dimensions (organizational, interactional, practical, and experiential), each composed of a set of criteria that allow a comparative analysis of different users’ work according to different health technologies. Conclusions: This framework can be applied both as an analytical tool in a research protocol and as an agenda to identify less visible adoption criteria for digital health technologies. %M 34734832 %R 10.2196/25159 %U https://www.jmir.org/2021/11/e25159 %U https://doi.org/10.2196/25159 %U http://www.ncbi.nlm.nih.gov/pubmed/34734832 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e23852 %T Adaptation of a Theory-Based Social Networking and Gamified App-Based Intervention to Improve Pre-Exposure Prophylaxis Adherence Among Young Men Who Have Sex With Men in Bangkok, Thailand: Qualitative Study %A Songtaweesin,Wipaporn Natalie %A LeGrand,Sara %A Bandara,Shashika %A Piccone,Caitlin %A Wongharn,Prissana %A Moonwong,Juthamanee %A Jupimai,Thidarat %A Saisaengjan,Chutima %A Theerawit,Tuangtip %A Muessig,Kathryn %A Hightow-Weidman,Lisa %A Puthanakit,Thanyawee %A Phanuphak,Nittaya %A Tangmunkongvorakul,Arunrat %+ Research Institute for Health Sciences, Chiang Mai University, 110 Intavarorot Road, Tambol Siphum, Amphur Muang, Chiang Mai, 50200, Thailand, 66 815942773, arunrat@rihes.org %K mobile health %K young men who have sex with men %K pre-exposure prophylaxis %K adherence %K mobile phone %D 2021 %7 4.11.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: HIV disproportionately affects young Thai men who have sex with men (YMSM). Recent studies report a high incidence and prevalence of HIV among Thai YMSM. The Thai national guidelines have recommended pre-exposure prophylaxis (PrEP) since 2014 for key populations; free PrEP has been piloted since 2019. Smartphone-based mobile health (mHealth) interventions provide an optimal platform for innovative PrEP adherence interventions for Thai YMSM. Objective: This study aims to adapt the P3 (Prepared, Protected, emPowered) app, developed with YMSM and transwomen in the United States to improve PrEP adherence and persistence for YMSM in Thailand. The app aims to provide daily adherence support and addresses gaps in staff available for large-scale PrEP rollout needed to see population-level effects of HIV prevention. Methods: We conducted focus group discussions (FGDs) with YMSM and key informant interviews (KIIs) with PrEP care providers in Bangkok, Thailand, to investigate PrEP adherence facilitators and barriers, preferences for functions and features in mHealth apps among YMSM, and how to best adapt the P3 app to the Thai context. We conducted four FGDs with 4-8 participants per group and 15 KIIs. Results: For FGDs, 23 YMSM participated with a mean age of 20 years (range 18-21), 96% (22/23) enrolled in full-time education, and all owned smartphones. The mean age of KII participants was 40 (range 26-60) years; most were state health service providers, with the majority being counselors (6/15, 40%) and physicians (6/15, 40%). Overall, the facilitators and barriers for PrEP adherence identified were similar to those of MSM and YMSM globally including the United States. Key themes included general recommendations for improving mHealth apps in Thailand, such as presenting reliable information in an appealing format, minimizing privacy risks, and addressing connectivity challenges. Additional themes focused on P3 Thailand adaptations and were related to cultural and stylistic preferences, engagement strategies, and recommendations for new functions. To develop the adapted app, P3 Thailand, these findings were balanced with resource limitations resulting in the prioritization of minor modifications: changes in app esthetics (color scheme, iconography, and imagery) and changes in the presentation of information in two of the app’s features. FGDs identified similar PrEP adherence facilitators and barriers to those already addressed within the app. Conclusions: The core elements of the P3 app address major PrEP facilitators and barriers for Thai YMSM; however, changes to the app features, including stylistic presentation, were needed to appropriately customize the app to the Thai context. Given the similarities of facilitators and barriers for PrEP adherence globally, adapting existing PrEP mHealth solutions based on input from end users and key informants provides a promising approach. However, partnerships with local app designers and developers can improve the adaptation process and final product. Trial Registration: ClinicalTrials.gov NCT04413708; http://clinicaltrials.gov/ct2/show/NCT04413708 %M 34734828 %R 10.2196/23852 %U https://www.jmir.org/2021/11/e23852 %U https://doi.org/10.2196/23852 %U http://www.ncbi.nlm.nih.gov/pubmed/34734828 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e31274 %T Adherence With Online Therapy vs Face-to-Face Therapy and With Online Therapy vs Care as Usual: Secondary Analysis of Two Randomized Controlled Trials %A Lippke,Sonia %A Gao,Lingling %A Keller,Franziska Maria %A Becker,Petra %A Dahmen,Alina %+ Department of Psychology and Methods, Jacobs University Bremen, Campus Ring 1, Bremen, 28759, Germany, 49 421200 ext 4730, s.lippke@jacobs-university.de %K psychotherapeutic aftercare %K medical rehabilitation %K online therapy %K face-to-face therapy %K care as usual %K retention %K dropout %D 2021 %7 3.11.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Adherence to internet-delivered interventions targeting mental health such as online psychotherapeutic aftercare is important for the intervention’s impact. High dropout rates limit the impact and generalizability of findings. Baseline differences may be putting patients at risk for dropping out, making comparisons between online with face-to-face (F2F) therapy and care as usual (CAU) necessary to examine. Objective: This study investigated adherence to online, F2F, and CAU interventions as well as study dropout among these groups and the subjective evaluation of the therapeutic relationship. Sociodemographic, social-cognitive, and health-related variables were considered. Methods: In a randomized controlled trial, 6023 patients were recruited, and 300 completed the baseline measures (T1), 144 completed T2 (retention 44%-52%), and 95 completed T3 (retention 24%-36%). Sociodemographic variables (eg, age, gender, marital status, educational level), social-cognitive determinants (eg, self-efficacy, social support), health-related variables (eg, depressiveness), and expectation towards the treatment for patients assigned to online or F2F were measured at T1. Results: There were no significant differences between the groups regarding dropout rates (χ21=0.02-1.06, P≥.30). Regarding adherence to the treatment condition, the online group outperformed the F2F and CAU conditions (P≤.01), indicating that patients randomized into the F2F and CAU control groups were much more likely to show nonadherent behavior in comparison with the online therapy groups. Within study groups, gender differences were significant only in the CAU group at T2, with women being more likely to drop out. At T3, age and marital status were also only significant in the CAU group. Patients in the online therapy group were significantly more satisfied with their treatment than patients in the F2F group (P=.02; Eta²=.09). Relationship satisfaction and success satisfaction were equally high (P>.30; Eta²=.02). Combining all study groups, patients who reported lower depressiveness scores at T1 (T2: odds ratio [OR] 0.55, 95% CI 0.35-0.87; T3: OR 0.56, 95% CI 0.37-0.92) were more likely to be retained, and patients who had higher self-efficacy (T2: OR 0.57, 95% CI 0.37-0.89; T3: OR 0.52, 95% CI 0.32-0.85) were more likely to drop out at T2 and T3. Additionally, at T3, the lower social support that patients reported was related to a higher likelihood of remaining in the study (OR 0.68, 95% CI 0.48-0.96). Comparing the 3 intervention groups, positive expectation was significantly related with questionnaire completion at T2 and T3 after controlling for other variables (T2: OR 1.64, 95% CI 1.08-2.50; T3: OR 1.59, 95% CI 1.01-2.51). Conclusions: While online interventions have many advantages over F2F variants such as saving time and effort to commute to F2F therapy, they also create difficulties for therapists and hinder their ability to adequately react to patients’ challenges. Accordingly, patient characteristics that might put them at risk for dropping out or not adhering to the treatment plan should be considered in future research and practice. Online aftercare, as described in this research, should be provided more often to medical rehabilitation patients. Trial Registration: ClinicalTrials.gov NCT04989842; https://clinicaltrials.gov/ct2/show/NCT04989842 %M 34730541 %R 10.2196/31274 %U https://www.jmir.org/2021/11/e31274 %U https://doi.org/10.2196/31274 %U http://www.ncbi.nlm.nih.gov/pubmed/34730541 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 8 %N 4 %P e16864 %T Biopsychosocial Profiles of Patients With Cardiac Disease in Remote Rehabilitation Processes: Mixed Methods Grounded Theory Approach %A Anttila,Marjo-Riitta %A Soderlund,Anne %A Paajanen,Teemu %A Kivistö,Heikki %A Kokko,Katja %A Sjögren,Tuulikki %+ Faculty of Sport and Health Sciences, University of Jyväskylä, PO BOX 35, Jyväskylä, FI-40014 University of Jyväskylä, Finland, 358 408054648, marjo-riitta.m-r.anttila@jyu.fi %K coronary disease %K experience %K biopsychosocial model %K digital cardiac rehabilitation %K mixed methods grounded theory %K web-based program %K physical activity %K self-efficacy %K quality of life %D 2021 %7 3.11.2021 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: Digital development has caused rehabilitation services and rehabilitees to become increasingly interested in using technology as a part of rehabilitation. This study was based on a previously published study that categorized 4 groups of patients with cardiac disease based on different experiences and attitudes toward technology (e-usage groups): feeling outsider, being uninterested, reflecting benefit, and enthusiastic using. Objective: This study identifies differences in the biopsychosocial profiles of patients with cardiac disease in e-usage groups and deepen the understanding of these profiles in cardiac rehabilitation. Methods: Focus group interviews and measurements were conducted with 39 patients with coronary heart disease, and the mean age was 54.8 (SD 9.4, range 34-77) years. Quantitative data were gathered during a 12-month rehabilitation period. First, we used analysis of variance and Tukey honestly significant difference test, a t test, or nonparametric tests—Mann–Whitney and Kruskal–Wallis tests—to compare the 4 e-usage groups—feeling outsider, being uninterested, reflecting benefit, and enthusiastic using—in biopsychosocial variables. Second, we compared the results of the 4 e-groups in terms of recommended and reference values. This analysis contained 13 variables related to biomedical, psychological, and social functioning. Finally, we formed biopsychosocial profiles based on the integration of the findings by constant comparative analysis phases through classic grounded theory. Results: The biomedical variables were larger for waistline (mean difference [MD] 14.2; 95% CI 1.0-27.5; P=.03) and lower for physical fitness (MD −0.72; 95% CI −1.4 to −0.06; P=.03) in the being uninterested group than in the enthusiastic using group. The feeling outsider group had lower physical fitness (MD −55.8; 95% CI −110.7 to −0.92; P=.047) than the enthusiastic using group. For psychosocial variables, such as the degree of self-determination in exercise (MD −7.3; 95% CI −13.5 to −1.1; P=.02), the being uninterested group had lower values than the enthusiastic using group. Social variables such as performing guided tasks in the program (P=.03) and communicating via messages (P=.03) were lower in the feeling outsider group than in the enthusiastic using group. The feeling outsider and being uninterested groups had high-risk lifestyle behaviors, and adherence to the web-based program was low. In contrast, members of the being uninterested group were interested in tracking their physical activity. The reflecting benefit and enthusiastic using groups had low-risk lifestyle behavior and good adherence to web-based interventions; however, the enthusiastic using group had low self-efficacy in exercise. These profiles showed how individuals reflected their lifestyle risk factors differently. We renamed the 4 groups as building self-awareness, increasing engagement, maintaining a healthy lifestyle balance, and strengthening self-confidence. Conclusions: The results facilitate more effective and meaningful personalization guidance and inform the remote rehabilitation. Professionals can tailor individual web-based lifestyle risk interventions using these biopsychosocial profiles. %M 34730548 %R 10.2196/16864 %U https://rehab.jmir.org/2021/4/e16864 %U https://doi.org/10.2196/16864 %U http://www.ncbi.nlm.nih.gov/pubmed/34730548 %0 Journal Article %@ 2562-0959 %I JMIR Publications %V 4 %N 2 %P e25918 %T Supporting Self-management Among Young People With Acne Vulgaris Through a Web-Based Behavioral Intervention: Development and Feasibility Randomized Controlled Trial %A Ip,Athena %A Muller,Ingrid %A Geraghty,Adam W A %A Rumsby,Kate %A Stuart,Beth %A Little,Paul %A Santer,Miriam %+ Primary Care, Population Sciences and Medical Education, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, United Kingdom, 44 (023) 8059 1779, a.ip@soton.ac.uk %K feasibility study %K acne vulgaris %K intervention study %K self-management %K primary care %K acne %K dermatology %D 2021 %7 3.11.2021 %9 Original Paper %J JMIR Dermatol %G English %X Background: Acne is a common skin condition that is most prevalent in young people. It can have a substantial impact on the quality of life, which can be minimized with the appropriate use of topical treatments. Nonadherence to topical treatments for acne is common and often leads to treatment failure. Objective: The aim of this study is to develop a web-based behavioral intervention to support the self-management of acne and to assess the feasibility of recruitment, retention, and engagement of users with the intervention. Methods: The intervention was developed iteratively using the LifeGuide software and following the person-based approach for intervention development. The target behavior was appropriate use of topical treatments. Barriers and facilitators identified from the qualitative research and evidence from the wider literature were used to identify techniques to improve and promote their use. Young people with acne aged 14-25 years who had received treatment for acne in the past 6 months were invited to participate through mail-out from primary care practices in the South of England in a parallel, unblinded randomized trial. Participants were automatically randomized using a computer-generated algorithm to usual care or to usual care plus access to the web-based intervention. Usage data was collected, and a series of questionnaires, including the primary outcome measure for skin-specific quality of life (Skindex-16), were collected at baseline and at the 4- and 6-week follow-ups. Results: A total of 1193 participants were invited, and 53 young people with acne were randomized to usual care (27/53, 51%) or usual care plus intervention (26/53, 49%). The response rate for the primary outcome measure (Skindex-16) was 87% at 4 weeks, 6 weeks, and at both time points. The estimate of mean scores between groups (with 95% CI) using linear regression showed a trend in the direction of benefit for the web-based intervention group in the primary outcome measure (Skindex-16) and secondary measures (Patient Health Questionnaire-4 and the Problematic Experiences of Therapy Scale). Intervention usage data showed high uptake of the core module in the usual care plus web-based intervention group, with 88% (23/26) of participants completing the module. Uptake of the optional modules was low, with less than half visiting each (myth-busting quiz: 27%; living with spots or acne: 42%; oral antibiotics: 19%; what are spots or acne: 27%; other treatments: 27%; talking to your general practitioner: 12%). Conclusions: This study demonstrated the feasibility of delivering a trial of a web-based intervention to support self-management in young people with acne. Additional work is needed before a full definitive trial, including enhancing engagement with the intervention, recruitment, and follow-up rates. Trial Registration: ISRCTN 78626638; https://tinyurl.com/n4wackrw %M 37632804 %R 10.2196/25918 %U https://derma.jmir.org/2021/2/e25918 %U https://doi.org/10.2196/25918 %U http://www.ncbi.nlm.nih.gov/pubmed/37632804 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e29862 %T Examining the Effectiveness of 3D Virtual Reality Training on Problem-solving, Self-efficacy, and Teamwork Among Inexperienced Volunteers Helping With Drug Use Prevention: Randomized Controlled Trial %A Chiang,Chih-Huei %A Huang,Chiu-Mieh %A Sheu,Jiunn-Jye %A Liao,Jung-Yu %A Hsu,Hsiao-Pei %A Wang,Shih-Wen %A Guo,Jong-Long %+ Department of Health Promotion and Health Education, College of Education, National Taiwan Normal University, No.162, Sec. 1, He-ping East Road, Taipei, 10610, Taiwan, 886 77493715, jonglong@ntnu.edu.tw %K 3D virtual reality %K volunteers %K problem-solving %K self-efficacy %K teamwork %D 2021 %7 2.11.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Illegal drug usage among adolescents is a critical health problem. The Taiwanese government provides an accompanying volunteer program to prevent students who experiment with drugs from reusing them. An appropriate training program can improve volunteers’ abilities to assist students using drugs. Problem-solving, self-efficacy, and teamwork are critical abilities for inexperienced volunteers who help with drug use prevention. By interacting with the animation or 3D virtual reality (VR) in the virtual scene, learners can immerse themselves in the virtual environment to learn, and 3D VR can increase learning opportunities and reduce the cost of human and material resources. Objective: The aim of this study was to examine the effectiveness of spherical video-based virtual reality (SVVR) training in improving problem-solving, self-efficacy, and teamwork among volunteers who helped prevent adolescents from using illegal drugs. Methods: This study used a randomized controlled design with a total of 68 participants in the experimental (n=35) and control (n=33) groups. The participants in the experimental group received the SVVR training program and their counterparts in the control group did not receive any training. Results: Generalized estimating equation analyses indicated that the experimental group showed significant posttraining improvements in problem-solving and self-efficacy but not teamwork when compared with the control group. Conclusions: The results of this study revealed that SVVR could improve participants’ problem-solving skills and self-efficacy for assisting students in not using illegal drugs. However, future studies are suggested to develop effective SVVR to assist inexperienced volunteers in enhancing their teamwork abilities. We believed that introducing the training program to more sites can enhance volunteer training so that volunteers can have a better companionship effect when helping students quit drugs. Trial Registration: ClinicalTrials.gov NCT05072431; https://clinicaltrials.gov/ct2/show/NCT05072431 %M 34726606 %R 10.2196/29862 %U https://www.jmir.org/2021/11/e29862 %U https://doi.org/10.2196/29862 %U http://www.ncbi.nlm.nih.gov/pubmed/34726606 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e28999 %T Exploratory Data Mining Techniques (Decision Tree Models) for Examining the Impact of Internet-Based Cognitive Behavioral Therapy for Tinnitus: Machine Learning Approach %A Rodrigo,Hansapani %A Beukes,Eldré W %A Andersson,Gerhard %A Manchaiah,Vinaya %+ School of Mathematical and Statistical Sciences, University of Texas Rio Grande Valley, 1201 W University Drive, Edinburgh, TX, 78539, United States, 1 9566652313, hansapani.rodrigo@utrgv.edu %K tinnitus %K internet interventions %K digital therapeutics %K cognitive behavioral therapy %K artificial intelligence %K machine learning %K data mining %K decision tree %K random forest %D 2021 %7 2.11.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: There is huge variability in the way that individuals with tinnitus respond to interventions. These experiential variations, together with a range of associated etiologies, contribute to tinnitus being a highly heterogeneous condition. Despite this heterogeneity, a “one size fits all” approach is taken when making management recommendations. Although there are various management approaches, not all are equally effective. Psychological approaches such as cognitive behavioral therapy have the most evidence base. Managing tinnitus is challenging due to the significant variations in tinnitus experiences and treatment successes. Tailored interventions based on individual tinnitus profiles may improve outcomes. Predictive models of treatment success are, however, lacking. Objective: This study aimed to use exploratory data mining techniques (ie, decision tree models) to identify the variables associated with the treatment success of internet-based cognitive behavioral therapy (ICBT) for tinnitus. Methods: Individuals (N=228) who underwent ICBT in 3 separate clinical trials were included in this analysis. The primary outcome variable was a reduction of 13 points in tinnitus severity, which was measured by using the Tinnitus Functional Index following the intervention. The predictor variables included demographic characteristics, tinnitus and hearing-related variables, and clinical factors (ie, anxiety, depression, insomnia, hyperacusis, hearing disability, cognitive function, and life satisfaction). Analyses were undertaken by using various exploratory machine learning algorithms to identify the most influencing variables. In total, 6 decision tree models were implemented, namely the classification and regression tree (CART), C5.0, GB, XGBoost, AdaBoost algorithm and random forest models. The Shapley additive explanations framework was applied to the two optimal decision tree models to determine relative predictor importance. Results: Among the six decision tree models, the CART (accuracy: mean 70.7%, SD 2.4%; sensitivity: mean 74%, SD 5.5%; specificity: mean 64%, SD 3.7%; area under the receiver operating characteristic curve [AUC]: mean 0.69, SD 0.001) and gradient boosting (accuracy: mean 71.8%, SD 1.5%; sensitivity: mean 78.3%, SD 2.8%; specificity: 58.7%, SD 4.2%; AUC: mean 0.68, SD 0.02) models were found to be the best predictive models. Although the other models had acceptable accuracy (range 56.3%-66.7%) and sensitivity (range 68.6%-77.9%), they all had relatively weak specificity (range 31.1%-50%) and AUCs (range 0.52-0.62). A higher education level was the most influencing factor for ICBT outcomes. The CART decision tree model identified 3 participant groups who had at least an 85% success probability following the undertaking of ICBT. Conclusions: Decision tree models, especially the CART and gradient boosting models, appeared to be promising in predicting ICBT outcomes. Their predictive power may be improved by using larger sample sizes and including a wider range of predictive factors in future studies. %M 34726612 %R 10.2196/28999 %U https://www.jmir.org/2021/11/e28999 %U https://doi.org/10.2196/28999 %U http://www.ncbi.nlm.nih.gov/pubmed/34726612 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 4 %N 4 %P e26842 %T Youths’ and Parents’ Experiences and Perceived Effects of Internet-Based Cognitive Behavioral Therapy for Anxiety Disorders in Primary Care: Mixed Methods Study %A Lilja,Josefine Lotten %A Rupcic Ljustina,Mirna %A Nissling,Linnea %A Larsson,Anna Caroline %A Weineland,Sandra %+ Research, Development, Education and Innovation, Primary Health Care, Region Västra Götaland, Kungsgatan 12, Göteborg, 411 19, Sweden, 46 769402969, josefine.lilja@vgregion.se %K internet %K CBT %K cognitive behavioral therapy %K adolescents %K parents %K anxiety %K primary care %K mixed methods %K experiences %K youths %K digital health %D 2021 %7 1.11.2021 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Anxiety is common among youths in primary care. Face-to-face treatment has been the first choice for clinicians, but during the COVID-19 pandemic, digital psychological interventions have substantially increased. Few studies have examined young people’s interest in internet treatment or the attitudes they and their parents have toward it. Objective: This study aims to investigate adolescents’ and parents’ attitudes toward and experiences of internet-based cognitive behavioral anxiety treatment in primary care and its presumptive effects. Methods: The study used mixed methods, analyzing qualitative data thematically and quantitative data with nonparametric analysis. Participants were 14 adolescents and 14 parents recruited in adolescent primary health care clinics. The adolescents and their parents filled out mental health questionnaires before and after treatment, and were interviewed during ongoing treatment. Results: The quantitative data indicated that the internet-delivered cognitive behavioral therapy program used in this study was successful in reducing symptoms (χ22=8.333; P=.02) and that adolescents’ motivation is essential to the treatment outcome (r=0.58; P=.03). The qualitative results show that youths highly value their independence and freedom to organize treatment work on their own terms. The parents expressed uncertainty about their role and how to support their child in treatment. It was important for parents to respect the youths’ need for autonomy while also engaging with them in the treatment work. Conclusions: Internet treatment in primary care is accepted by both youths and their parents, who need clarification about the difference between their role and the therapist’s role. Patient motivation should be considered before treatment, and therapists need to continue to develop the virtual alliance. Finally, primary care should be clearer in informing adolescents and their parents about the possibility of internet treatment. %M 34723830 %R 10.2196/26842 %U https://pediatrics.jmir.org/2021/4/e26842 %U https://doi.org/10.2196/26842 %U http://www.ncbi.nlm.nih.gov/pubmed/34723830 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 10 %P e30768 %T Moderators of the Effect of a Self-directed Digitally Delivered Exercise Program for People With Knee Osteoarthritis: Exploratory Analysis of a Randomized Controlled Trial %A Nelligan,Rachel K %A Hinman,Rana S %A McManus,Fiona %A Lamb,Karen E %A Bennell,Kim L %+ Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, 161 Barry Street, Parkville, 3010, Australia, 61 403652115, rachel.nelligan@unimelb.edu.au %K digital %K text messaging %K exercise %K moderators %K osteoarthritis %K RCT %K clinical trial %K subgroups %K pain %K function %K knee osteoarthritis %K rehabilitation %K digital health %D 2021 %7 29.10.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: A 24-week self-directed digitally delivered intervention was found to improve pain and function in people with knee osteoarthritis (OA). However, it is possible that this intervention may be better suited to certain subgroups of people with knee OA compared to others. Objective: The aim of this study was to explore whether certain individual baseline characteristics moderate the effects of a self-directed digitally delivered intervention on changes in pain and function over 24 weeks in people with knee OA. Methods: An exploratory analysis was conducted on data from a randomized controlled trial involving 206 people with a clinical diagnosis of knee OA. This trial compared a self-directed digitally delivered intervention comprising of web-based education, exercise, and physical activity program supported by automated exercise behavior change mobile phone text messages to web-based education alone (control). The primary outcomes were changes in overall knee pain (assessed on an 11-point numerical rating scale) and physical function (assessed using the Western Ontario and McMaster Universities Osteoarthritis Index function subscale [WOMAC]) at 24 weeks. Five baseline patient characteristics were selected as the potential moderators: (1) number of comorbidities, (2) number of other painful joints, (3) pain self-efficacy, (4) exercise self-efficacy, and (5) self-perceived importance of exercise. Separate linear regression models for each primary outcome and each potential moderator were fit, including treatment group, moderator, and interaction between treatment group and moderator, adjusting for the outcome at baseline. Results: There was evidence that pain self-efficacy moderated the effect of the intervention on physical function compared to the control at 24 weeks (interaction P=.02). Posthoc assessment of the mean change in WOMAC function by treatment arm showed that each 1-unit increase in baseline pain self-efficacy was associated with a 1.52 (95% CI 0.27 to 2.78) unit improvement in the control group. In contrast, a reduction of 0.62 (95% CI –1.93 to 0.68) units was observed in the intervention group with each unit increase in pain self-efficacy. There was only weak evidence that pain self-efficacy moderated the effect of the intervention on pain and that number of comorbidities, number of other painful joints, exercise self-efficacy, or exercise importance moderated the effect of the intervention on pain or function. Conclusions: With the exception of pain self-efficacy, which moderated changes in function but not pain, we found limited evidence that our selected baseline patient characteristics moderated intervention outcomes. This indicates that people with a range of baseline characteristics respond similarly to the unsupervised digitally delivered exercise intervention. As these findings are exploratory in nature, they require confirmation in future studies. %M 34714252 %R 10.2196/30768 %U https://www.jmir.org/2021/10/e30768 %U https://doi.org/10.2196/30768 %U http://www.ncbi.nlm.nih.gov/pubmed/34714252 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 10 %P e29001 %T Factors Associated With Behavioral and Psychological Symptoms of Dementia: Prospective Observational Study Using Actigraphy %A Cho,Eunhee %A Kim,Sujin %A Hwang,Sinwoo %A Kwon,Eunji %A Heo,Seok-Jae %A Lee,Jun Hong %A Ye,Byoung Seok %A Kang,Bada %+ Mo-Im Kim Nursing Research Institute, College of Nursing, Yonsei University, 50-1, Yonsei-Ro, Seodaemun-gu, Seoul, 03722, Republic of Korea, 82 222283274, bdkang@yuhs.ac %K behavioral and psychological symptoms %K dementia %K older adults %K actigraphy %K sleep %K activity %K risk factors %D 2021 %7 29.10.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Although disclosing the predictors of different behavioral and psychological symptoms of dementia (BPSD) is the first step in developing person-centered interventions, current understanding is limited, as it considers BPSD as a homogenous construct. This fails to account for their heterogeneity and hinders development of interventions that address the underlying causes of the target BPSD subsyndromes. Moreover, understanding the influence of proximal factors—circadian rhythm–related factors (ie, sleep and activity levels) and physical and psychosocial unmet needs states—on BPSD subsyndromes is limited, due to the challenges of obtaining objective and/or continuous time-varying measures. Objective: The aim of this study was to explore factors associated with BPSD subsyndromes among community-dwelling older adults with dementia, considering sets of background and proximal factors (ie, actigraphy-measured sleep and physical activity levels and diary-based caregiver-perceived symptom triggers), guided by the need-driven dementia-compromised behavior model. Methods: A prospective observational study design was employed. Study participants included 145 older adults with dementia living at home. The mean age at baseline was 81.2 (SD 6.01) years and the sample consisted of 86 (59.3%) women. BPSD were measured with a BPSD diary kept by caregivers and were categorized into seven subsyndromes. Independent variables consisted of background characteristics and proximal factors (ie, sleep and physical activity levels measured using actigraphy and caregiver-reported contributing factors assessed using a BPSD diary). Generalized linear mixed models (GLMMs) were used to examine the factors that predicted the occurrence of BPSD subsyndromes. We compared the models based on the Akaike information criterion, the Bayesian information criterion, and likelihood ratio testing. Results: Compared to the GLMMs with only background factors, the addition of actigraphy and diary-based data improved model fit for every BPSD subsyndrome. The number of hours of nighttime sleep was a predictor of the next day’s sleep and nighttime behaviors (odds ratio [OR] 0.9, 95% CI 0.8-1.0; P=.005), and the amount of energy expenditure was a predictor for euphoria or elation (OR 0.02, 95% CI 0.0-0.5; P=.02). All subsyndromes, except for euphoria or elation, were significantly associated with hunger or thirst and urination or bowel movements, and all BPSD subsyndromes showed an association with environmental change. Age, marital status, premorbid personality, and taking sedatives were predictors of specific BPSD subsyndromes. Conclusions: BPSD are clinically heterogeneous, and their occurrence can be predicted by different contributing factors. Our results for various BPSD suggest a critical window for timely intervention and care planning. Findings from this study will help devise symptom-targeted and individualized interventions to prevent and manage BPSD and facilitate personalized dementia care. %M 34714244 %R 10.2196/29001 %U https://www.jmir.org/2021/10/e29001 %U https://doi.org/10.2196/29001 %U http://www.ncbi.nlm.nih.gov/pubmed/34714244 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 10 %P e26280 %T The Development of a Web-Based Tobacco Tracker Tool to Crowdsource Campus Environmental Reports for Smoke and Tobacco–Free College Policies: Mixed Methods Study %A Loureiro,Sabrina F %A Pulvers,Kim %A Gosdin,Melissa M %A Clift,Keavagh %A Rice,Myra %A Tong,Elisa K %+ Department of Internal Medicine, University of California Davis, 4150 V Street, Suite 2400, Sacramento, CA, 95817, United States, 1 (916) 734 7005, ektong@ucdavis.edu %K tobacco cessation %K college smoke and tobacco–free policies %K crowdsourcing %K environmental reporting %K public health %K smoke and tobacco research %D 2021 %7 29.10.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: College campuses in the United States have begun implementing smoke and tobacco–free policies to discourage the use of tobacco. Smoke and tobacco–free policies, however, are contingent upon effective policy enforcement. Objective: This study aimed to develop an empirically derived web-based tracking tool (Tracker) for crowdsourcing campus environmental reports of tobacco use and waste to support smoke and tobacco–free college policies. Methods: An exploratory sequential mixed methods approach was utilized to inform the development and evaluation of Tracker. In October 2018, three focus groups across 2 California universities were conducted and themes were analyzed, guiding Tracker development. After 1 year of implementation, users were asked in April 2020 to complete a survey about their experience. Results: In the focus groups, two major themes emerged: barriers and facilitators to tool utilization. Further Tracker development was guided by focus group input to address these barriers (eg, information, policing, and logistical concerns) and facilitators (eg, environmental motivators and positive reinforcement). Amongst 1163 Tracker reports, those who completed the user survey (n=316) reported that the top motivations for using the tool had been having a cleaner environment (212/316, 79%) and health concerns (185/316, 69%). Conclusions: Environmental concerns, a motivator that emerged in focus groups, shaped Tracker’s development and was cited by the majority of users surveyed as a top motivator for utilization. %M 34714248 %R 10.2196/26280 %U https://www.jmir.org/2021/10/e26280 %U https://doi.org/10.2196/26280 %U http://www.ncbi.nlm.nih.gov/pubmed/34714248 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 10 %P e28924 %T Implementation Strategies to Improve Engagement With a Multi-Institutional Patient Portal: Multimethod Study %A Fujioka,Jamie Keiko %A Bickford,Julia %A Gritke,Jennifer %A Stamenova,Vess %A Jamieson,Trevor %A Bhatia,R Sacha %A Desveaux,Laura %+ Women's College Hospital Institute for Health Systems Solutions and Virtual Care, 76 Grenville St, Room 6319, Toronto, ON, M5S 1B2, Canada, 1 416 323 6400, laura.desveaux@wchospital.ca %K patient portal %K electronic health record %K patient health record %K digital health %D 2021 %7 28.10.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Comprehensive multi-institutional patient portals that provide patients with web-based access to their data from across the health system have been shown to improve the provision of patient-centered and integrated care. However, several factors hinder the implementation of these portals. Although barriers and facilitators to patient portal adoption are well documented, there is a dearth of evidence examining how to effectively implement multi-institutional patient portals that transcend traditional boundaries and disparate systems. Objective: This study aims to explore how the implementation approach of a multi-institutional patient portal impacted the adoption and use of the technology and to identify the lessons learned to guide the implementation of similar patient portal models. Methods: This multimethod study included an analysis of quantitative and qualitative data collected during an evaluation of the multi-institutional MyChart patient portal that was deployed in Southwestern Ontario, Canada. Descriptive statistics were performed to understand the use patterns during the first 15 months of implementation (between August 2018 and October 2019). In addition, 42 qualitative semistructured interviews were conducted with 18 administrative stakeholders, 16 patients, 7 health care providers, and 1 informal caregiver to understand how the implementation approach influenced user experiences and to identify strategies for improvement. Qualitative data were analyzed using an inductive thematic analysis approach. Results: Between August 2018 and October 2019, 15,271 registration emails were sent, with 67.01% (10,233/15,271) registered for an account across 38 health care sites. The median number of patients registered per site was 19, with considerable variation (range 1-2114). Of the total number of sites, 55% (21/38) had ≤30 registered patients, whereas only 2 sites had over 1000 registered patients. Interview participants perceived that the patient experience of the portal would have been improved by enhancing the data comprehensiveness of the technology. They also attributed the lack of enrollment to the absence of a broad rollout and marketing strategy across sites. Participants emphasized that provider engagement, change management support, and senior leadership endorsement were central to fostering uptake. Finally, many stated that regional alignment and policy support should have been sought to streamline implementation efforts across participating sites. Conclusions: Without proper management and planning, multi-institutional portals can suffer from minimal adoption. Data comprehensiveness is the foundational component of these portals and requires aligned policies and a key base of technology infrastructure across all participating sites. It is important to look beyond the category of the technology (ie, patient portal) and consider its functionality (eg, data aggregation, appointment scheduling, messaging) to ensure that it aligns with the underlying strategic priorities of the deployment. It is also critical to establish a clear vision and ensure buy-ins from organizational leadership and health care providers to support a cultural shift that will enable a meaningful and widespread engagement. %M 34709195 %R 10.2196/28924 %U https://www.jmir.org/2021/10/e28924 %U https://doi.org/10.2196/28924 %U http://www.ncbi.nlm.nih.gov/pubmed/34709195 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 10 %P e32548 %T The Effect of a WeChat-Based Tertiary A-Level Hospital Intervention on Medication Adherence and Risk Factor Control in Patients With Stable Coronary Artery Disease: Multicenter Prospective Study %A Shi,Boqun %A Liu,Xi %A Dong,Qiuting %A Yang,Yuxiu %A Cai,Zhongxing %A Wang,Haoyu %A Yin,Dong %A Wang,Hongjian %A Dou,Kefei %A Song,Weihua %+ Cardiometabolic Medicine Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No 167 North Lishi Road, Xicheng District, Beijing, 100037, China, 86 1088396863, songweihua@fuwai.com %K WeChat %K telemedicine %K coronary artery disease %K medication adherence %K mobile phone %D 2021 %7 27.10.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: In China, ischemic heart disease is the main cause of mortality. Having cardiac rehabilitation and a secondary prevention program in place is a class IA recommendation for individuals with coronary artery disease. WeChat-based interventions seem to be feasible and efficient for the follow-up and management of chronic diseases. Objective: This study aims to evaluate the effectiveness of a tertiary A-level hospital, WeChat-based telemedicine intervention in comparison with conventional community hospital follow-up on medication adherence and risk factor control in individuals with stable coronary artery disease. Methods: In this multicenter prospective study, 1424 patients with stable coronary artery disease in Beijing, China, were consecutively enrolled between September 2018 and September 2019 from the Fuwai Hospital and 4 community hospitals. At 1-, 3-, 6-, and 12-month follow-up, participants received healthy lifestyle recommendations and medication advice. Subsequently, the control group attended an offline outpatient clinic at 4 separate community hospitals. The intervention group had follow-up visits through WeChat-based telemedicine management. The main end point was medication adherence, which was defined as participant compliance in taking all 4 cardioprotective medications that would improve the patient’s outcome (therapies included antiplatelet therapy, β-blockers, statins, and angiotensin-converting-enzyme inhibitors or angiotensin-receptor blockers). Multivariable generalized estimating equations were used to compare the primary and secondary outcomes between the 2 groups and to calculate the relative risk (RR) at 12 months. Propensity score matching and inverse probability of treatment weighting were performed as sensitivity analyses, and propensity scores were calculated using a multivariable logistic regression model. Results: At 1 year, 88% (565/642) of patients in the intervention group and 91.8% (518/564) of patients in the control group had successful follow-up data. We matched 257 pairs of patients between the intervention and control groups. There was no obvious advantage in medication adherence with the 4 cardioprotective drugs in the intervention group (172/565, 30.4%, vs 142/518, 27.4%; RR 0.99, 95% CI 0.97-1.02; P=.65). The intervention measures improved smoking cessation (44/565, 7.8%, vs 118/518, 22.8%; RR 0.48, 95% CI 0.44-0.53; P<.001) and alcohol restriction (33/565, 5.8%, vs 91/518, 17.6%; RR 0.47, 95% CI 0.42-0.54; P<.001). Conclusions: The tertiary A-level hospital, WeChat-based intervention did not improve adherence to the 4 cardioprotective medications compared with the traditional method. Tertiary A-level hospital, WeChat-based interventions have a positive effect on improving lifestyle, such as quitting drinking and smoking, in patients with stable coronary artery disease and can be tried as a supplement to community hospital follow-up. Trial Registration: ClinicalTrials.gov NCT04795505; https://clinicaltrials.gov/ct2/show/NCT04795505 %M 34569467 %R 10.2196/32548 %U https://mhealth.jmir.org/2021/10/e32548 %U https://doi.org/10.2196/32548 %U http://www.ncbi.nlm.nih.gov/pubmed/34569467 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 4 %N 4 %P e30169 %T A Chatbot to Engage Parents of Preterm and Term Infants on Parental Stress, Parental Sleep, and Infant Feeding: Usability and Feasibility Study %A Wong,Jill %A Foussat,Agathe C %A Ting,Steven %A Acerbi,Enzo %A van Elburg,Ruurd M %A Mei Chien,Chua %+ Department of Neonatology, KK Women’s and Children’s Hospital, 100 Bukit Timah Rd, Singapore, 229899, Singapore, 65 6394 1240, chua.mei.chien@singhealth.com.sg %K chatbot %K parental stress %K parental sleep %K infant feeding %K preterm infants %K term infants %K sleep %K stress %K eHealth %K support %K anxiety %K usability %D 2021 %7 26.10.2021 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Parents commonly experience anxiety, worry, and psychological distress in caring for newborn infants, particularly those born preterm. Web-based therapist services may offer greater accessibility and timely psychological support for parents but are nevertheless labor intensive due to their interactive nature. Chatbots that simulate humanlike conversations show promise for such interactive applications. Objective: The aim of this study is to explore the usability and feasibility of chatbot technology for gathering real-life conversation data on stress, sleep, and infant feeding from parents with newborn infants and to investigate differences between the experiences of parents with preterm and term infants. Methods: Parents aged ≥21 years with infants aged ≤6 months were enrolled from November 2018 to March 2019. Three chatbot scripts (stress, sleep, feeding) were developed to capture conversations with parents via their mobile devices. Parents completed a chatbot usability questionnaire upon study completion. Responses to closed-ended questions and manually coded open-ended responses were summarized descriptively. Open-ended responses were analyzed using the latent Dirichlet allocation method to uncover semantic topics. Results: Of 45 enrolled participants (20 preterm, 25 term), 26 completed the study. Parents rated the chatbot as “easy” to use (mean 4.08, SD 0.74; 1=very difficult, 5=very easy) and were “satisfied” (mean 3.81, SD 0.90; 1=very dissatisfied, 5 very satisfied). Of 45 enrolled parents, those with preterm infants reported emotional stress more frequently than did parents of term infants (33 vs 24 occasions). Parents generally reported satisfactory sleep quality. The preterm group reported feeding problems more frequently than did the term group (8 vs 2 occasions). In stress domain conversations, topics linked to “discomfort” and “tiredness” were more prevalent in preterm group conversations, whereas the topic of “positive feelings” occurred more frequently in the term group conversations. Interestingly, feeding-related topics dominated the content of sleep domain conversations, suggesting that frequent or irregular feeding may affect parents’ ability to get adequate sleep or rest. Conclusions: The chatbot was successfully used to collect real-time conversation data on stress, sleep, and infant feeding from a group of 45 parents. In their chatbot conversations, term group parents frequently expressed positive emotions, whereas preterm group parents frequently expressed physical discomfort and tiredness, as well as emotional stress. Overall, parents who completed the study gave positive feedback on their user experience with the chatbot as a tool to express their thoughts and concerns. Trial Registration: ClinicalTrials.gov NCT03630679; https://clinicaltrials.gov/ct2/show/NCT03630679 %M 34544679 %R 10.2196/30169 %U https://pediatrics.jmir.org/2021/4/e30169 %U https://doi.org/10.2196/30169 %U http://www.ncbi.nlm.nih.gov/pubmed/34544679 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 10 %P e29397 %T Predictors of Booster Engagement Following a Web-Based Brief Intervention for Alcohol Misuse Among National Guard Members: Secondary Analysis of a Randomized Controlled Trial %A Coughlin,Lara N %A Blow,Frederic C %A Walton,Maureen %A Ignacio,Rosalinda V %A Walters,Heather %A Massey,Lynn %A Barry,Kristen L %A McCormick,Richard %+ Addiction Center, Department of Psychiatry, University of Michigan, 2800 Plymouth Rd, Ann Arbor, MI, 48109, United States, 1 734 615 4774, laraco@med.umich.edu %K alcohol use %K National Guard %K brief intervention %K boosters %K engagement %D 2021 %7 26.10.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: Alcohol misuse is a major health concern among military members. Reserve component members face unique barriers as they live off base with limited access to behavioral health services. Web and app-based brief interventions are a promising means to improve access to treatment for those who misuse alcohol, with the use of booster sessions to enhance effectiveness, solidify gains, and reinforce changes. However, little is known about who will engage in booster sessions. Objective: This study aims to evaluate booster engagement across booster delivery modalities (Web and Peer) and identify participant-specific factors associated with booster session engagement. Methods: Following a brief web-based alcohol misuse intervention in National Guard members (N=739), we examined engagement in a series of three booster sessions. Using unadjusted and adjusted models, demographic and clinical characteristics that may serve as predictors of booster session engagement were examined across the 2 arms of the trial with different types of booster sessions: peer-delivered (N=245) and web-delivered (N=246). Results: Booster session completion was greater for Peer than Web Booster sessions, with 142 (58%) service members in the Peer Booster arm completing all three boosters compared with only 108 (44%) of participants in the Web Booster arm (χ23=10.3; P=.006). In a model in which the 2 groups were combined, socioeconomic factors predicted booster engagement. In separate models, the demographic and clinical predictors of booster engagement varied between the 2 delivery modalities. Conclusions: The use of peer-delivered boosters, especially among subsets of reserve members at risk of lack of engagement, may foster greater uptake and improve treatment outcomes. Trial Registration: ClinicalTrials.gov NCT02181283; https://clinicaltrials.gov/ct2/show/NCT02181283 %M 34698652 %R 10.2196/29397 %U https://mental.jmir.org/2021/10/e29397 %U https://doi.org/10.2196/29397 %U http://www.ncbi.nlm.nih.gov/pubmed/34698652 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 10 %P e19915 %T Comparative Effectiveness of Enhanced Patient Instructions for Bowel Preparation Before Colonoscopy: Network Meta-analysis of 23 Randomized Controlled Trials %A Tian,Xu %A Yi,Li-Juan %A Han,Yang %A Chen,Hui %A Liu,Xiao-Ling %A Chen,Wei-Qing %A Jiménez-Herrera,Maria F %+ Nursing Department, Universitat Rovira i Virgili, Avinguda Catalunya, 35, Tarragona, 43002, Spain, 34 977299426, maria.jimenez@urv.cat %K colonoscopy %K bowel preparation %K patient instruction %K systematic review %K network meta-analysis %D 2021 %7 25.10.2021 %9 Review %J J Med Internet Res %G English %X Background: Various enhanced patient instructions (EPIs) have been used for bowel preparation (BP) and our previous meta-analysis also demonstrated the efficacy of EPIs in increasing the colonic polyp and adenoma detection rates; however, the optimal method for adequate BP has not yet been developed. Objective: We performed a network meta-analysis to determine the optimal instructions. Methods: We searched for randomized controlled trials (RCTs) comparing the effectiveness of EPIs with each other or standard patient instructions (SPIs) for BP. We performed direct and Bayesian network meta-analyses for all instructions and used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria to appraise the quality of evidence. Results: We included 23 RCTs (7969 patients) comparing 10 different instructions. In direct meta-analyses, most of the EPIs, except visual aids and mobile apps, increased the adequate preparation rate (APR). Network meta-analyses showed that additional explanations were superior to visual aids (odds ratio [OR] 0.35, 95% CI 0.19-0.59), telephone calls (OR 0.62, 95% CI 0.37-0.99), educational videos (OR 0.79, 95% CI 0.5-0.77), and mobile apps (OR 0.33, 95% CI 0.14-0.68) with low-to-high-quality evidence; newly designed booklets (OR 3.28, 95% CI 1.59-6.16), SMS text messaging (OR 2.33, 95% CI 1.28-3.91), telephone calls (OR 1.86, 95% CI 1.03-1.78), educational videos (OR 2.33, 95% CI 1.40-3.65), and social media applications (OR 2.42, 95% CI 1.4-3.93) were superior to visual aids and mobile apps with low-to-high-quality evidence. SMS text messaging, telephone calls, and social media applications increase adherence to and satisfaction with the BP regime. Social media applications reduce the risk of adverse events (AEs). Telephone calls and social media applications increase the polyp detection rate (PDR). Conclusions: Newly designed booklets, telephone calls, educational videos, and social media applications can improve the quality of BP. Telephone calls and social media applications improve adherence to and satisfaction with the BP regime, reduce the risk of AEs, and increase the PDR. Trial Registration: INPLASY (International Platform of Registered Systematic Review and Meta-analysis Protocols) INPLASY2020120103; https://inplasy.com/inplasy-2020-12-0103/ %M 34694227 %R 10.2196/19915 %U https://www.jmir.org/2021/10/e19915 %U https://doi.org/10.2196/19915 %U http://www.ncbi.nlm.nih.gov/pubmed/34694227 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 5 %N 2 %P e33252 %T Values of Importance to Patients With Cardiovascular Disease as a Foundation for eHealth Design and Evaluation: Mixed Methods Study %A Bente,Britt E %A Wentzel,Jobke %A Groeneveld,Rik GH %A IJzerman,Renée VH %A de Buisonjé,David R %A Breeman,Linda D %A Janssen,Veronica R %A Kraaijenhagen,Roderik %A Pieterse,Marcel E %A Evers,Andrea WM %A van Gemert-Pijnen,Julia EWC %+ Department of Psychology, Health and Technology, Centre for eHealth and Wellbeing Research, University of Twente, Drienerlolaan 5, Enschede, 7522 NB, Netherlands, 31 53 489 9660, b.e.bente@utwente.nl %K patient values %K health behavior %K lifestyle %K mobile app %K user-centered design %K eHealth %K cardiovascular disease %K behavior %K app %K design %K cardiovascular %K evaluation %K platform %K support %K intervention %D 2021 %7 22.10.2021 %9 Original Paper %J JMIR Cardio %G English %X Background: eHealth interventions are developed to support and facilitate patients with lifestyle changes and self-care tasks after being diagnosed with a cardiovascular disease (CVD). Creating long-lasting effects on lifestyle change and health outcomes with eHealth interventions is challenging and requires good understanding of patient values. Objective: The aim of the study was to identify values of importance to patients with CVD to aid in designing a technological lifestyle platform. Methods: A mixed method design was applied, combining data from usability testing with an additional online survey study, to validate the outcomes of the usability tests. Results: A total of 11 relevant patient values were identified, including the need for security, support, not wanting to feel anxious, tailoring of treatment, and personalized, accessible care. The validation survey shows that all values but one (value 9: To have extrinsic motivation to accomplish goals or activities [related to health/lifestyle]) were regarded as important/very important. A rating of very unimportant or unimportant was given by less than 2% of the respondents (value 1: 4/641, 0.6%; value 2: 10/641, 1.6%; value 3: 9/641, 1.4%; value 4: 5/641, 0.8%; value 5: 10/641, 1.6%; value 6: 4/641, 0.6%; value 7: 10/639, 1.6%; value 8: 4/639, 0.6%; value 10: 3/636, 0.5%; value 11: 4/636, 0.6%) to all values except but one (value 9: 56/636, 8.8%). Conclusions: There is a high consensus among patients regarding the identified values reflecting goals and themes central to their lives, while living with or managing their CVD. The identified values can serve as a foundation for future research to translate and integrate these values into the design of the eHealth technology. This may call for prioritization of values, as not all values can be met equally. %M 34677130 %R 10.2196/33252 %U https://cardio.jmir.org/2021/2/e33252 %U https://doi.org/10.2196/33252 %U http://www.ncbi.nlm.nih.gov/pubmed/34677130 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 10 %P e29989 %T Examining the Preliminary Effectiveness and Acceptability of a Web-Based Training Program for Australian Secondary School Teachers: Pilot Study of the BEAM (Building Educators’ Skills in Adolescent Mental Health) Program %A Parker,Belinda L %A Anderson,Melissa %A Batterham,Philip J %A Gayed,Aimee %A Subotic-Kerry,Mirjana %A Achilles,Melinda R %A Chakouch,Cassandra %A Werner-Seidler,Aliza %A Whitton,Alexis E %A O’Dea,Bridianne %+ Black Dog Institute, 3 Hospital Rd, Randwick, NSW, 2031, Australia, 61 29382 8509, b.odea@blackdog.org.au %K mental health %K training %K high school teachers %K youth %K mental health programs %K secondary schools %D 2021 %7 22.10.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: Secondary schools are increasingly supporting adolescents’ mental health and well-being, yet many teachers report that they lack the skills and confidence to do so. Building Educators’ skills in Adolescent Mental Health (BEAM) is a web-based training program developed to improve secondary school teachers’ knowledge and confidence in caring for students’ mental health. Objective: This pilot study examined the preliminary effectiveness and acceptability of the BEAM program for improving mental health knowledge, attitudes, confidence, helping behaviors, and psychological distress among secondary school teachers. Methods: A single-arm pilot trial was conducted from July to December 2019 among secondary school teachers located in New South Wales, Australia, who were employed in leadership positions responsible for managing student well-being (ie, Year Advisors). Participants had access to the BEAM program for 6 weeks. Self-report surveys, delivered at baseline, postintervention (6-weeks post baseline) and 3-month follow-up (19 weeks post baseline) were used to measure changes in training outcomes. Acceptability was assessed by program use, barriers, satisfaction, and participants’ perceptions of program effectiveness. Results: A total of 70 secondary school teachers took part (mean age 36.5 years, SD 9.41 years, range 24-60 years). Significant improvements in confidence were reported at postintervention and 3-month follow-up. Significant improvements in helping behaviors were reported at 3-month follow-up only. There was also a significant reduction in psychological distress at postintervention. Participants agreed that the program content was easy to understand and relevant, but program completion was challenged by lack of time, competing priorities, and forgetfulness. Conclusions: Findings indicated that a web-based training program may be beneficial for improving secondary school teachers’ abilities to care for students’ mental health; however, program modifications are required to increase training completions. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619000821190, Universal Trial Number U1111-1232-7680; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377529 %M 34677134 %R 10.2196/29989 %U https://mental.jmir.org/2021/10/e29989 %U https://doi.org/10.2196/29989 %U http://www.ncbi.nlm.nih.gov/pubmed/34677134 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 10 %P e27263 %T An Enhanced SMS Text Message–Based Support and Reminder Program for Young Adults With Type 2 Diabetes (TEXT2U): Randomized Controlled Trial %A Middleton,Timothy %A Constantino,Maria %A McGill,Margaret %A D'Souza,Mario %A Twigg,Stephen M %A Wu,Ted %A Thiagalingam,Aravinda %A Chow,Clara %A Wong,Jencia %+ Diabetes Centre, Royal Prince Alfred Hospital, Missenden Road, Camperdown, 2050, Australia, 61 295155888, timothy.middleton@health.nsw.gov.au %K young-onset type 2 diabetes %K SMS %K clinic attendance %K engagement %K diabetes %K digital health %K mobile health %K adolescents %D 2021 %7 21.10.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Clinic attendance, metabolic control, engagement in self-management, and psychological health are suboptimal in young-onset (age of onset <40 years) type 2 diabetes. Objective: We examined the effectiveness of an enhanced SMS text message–based support and reminder program in improving clinic attendance, metabolic control, engagement in self-management, and psychological health in young-onset type 2 diabetes. Methods: A 12-month, parallel-arm, randomized controlled trial comparing an enhanced, semipersonalized SMS text message–based intervention (incorporating 1-8 supportive and/or informative text messages per month) against standard care was conducted in a specialized clinic for young adult type 2 diabetes. The primary outcome was maintenance of 100% attendance at scheduled quarterly clinical appointments. Secondary outcomes included (1) metabolic indices, (2) pathology and self-monitored blood glucose (SMBG) data availability, and (3) psychosocial well-being. Results: A total of 40 participants were randomized, and 32 completed their 12-month study visit. The average participant age was 32.7 (SD 5.1) years, 50% (20/40) were male, and baseline glycated hemoglobin A1c (HbA1c) was 7.3% (SD 1.9%) (56 mmol/mol, SD 20). A higher proportion of the intervention group achieved 100% attendance (12/21, 57%, vs 5/19, 26%, for the control group); Kaplan-Meier analysis demonstrated significantly greater cumulative attendance in the intervention group (P=.04). There were no between-group differences in HbA1c, BMI, lipids, or availability of pathology and SMBG data. Odds of recording an improvement in the Diabetes Empowerment Scale–Short Form score were higher in the intervention group at 6 months (odds ratio [OR] 4.3, 95% CI 1.1-17), with attenuation of this effect at study end (OR 3.1, 95% CI 0.9-11). Program acceptability was high; >90% of participants would recommend the program to new patients. Conclusions: An enhanced SMS text message–based support and reminder program doubled scheduled clinic attendance rates for patients with young-onset type 2 diabetes. The program was highly acceptable and provided early support for patient empowerment but had no significant effect on measures of metabolic control or self-management. Trial Registration: Australian and New Zealand Clinical Trials Registry (ACTRN12618000479202); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373579 %M 34524102 %R 10.2196/27263 %U https://www.jmir.org/2021/10/e27263 %U https://doi.org/10.2196/27263 %U http://www.ncbi.nlm.nih.gov/pubmed/34524102 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 10 %P e32100 %T Outcomes of a Blended Care Coaching Program for Clients Presenting With Moderate Levels of Anxiety and Depression: Pragmatic Retrospective Study %A Wu,Monica S %A Chen,Shih-Yin %A Wickham,Robert E %A O’Neil-Hart,Shane %A Chen,Connie %A Lungu,Anita %+ Lyra Health, 287 Lorton Ave, Burlingame, CA, 94010, United States, 1 877 505 7147, mwu@lyrahealth.com %K blended care %K coaching %K cognitive %K behavior %K depression %K anxiety %K digital health %K retrospective %K mental health %K CBT %K cognitive behavioral therapy %K outcome %K video conference %D 2021 %7 21.10.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: Depression and anxiety are leading causes of disability worldwide, but access to quality mental health care is limited by myriad factors. Cognitive-behavioral coaching is rooted in evidence-based principles and has the potential to address some of these unmet care needs. Harnessing technology to facilitate broader dissemination within a blended care model shows additional promise for overcoming barriers to care. Objective: The aim of this study is to evaluate the outcomes of a blended care coaching (BCC) program for clients presenting with moderate levels of anxiety and depression in real-world settings. Methods: This study examined retrospective data from US-based individuals (N=1496) who presented with moderate levels of depression and anxiety symptoms and who received blended care coaching services. Using a short-term framework, clients met with coaches via a secure video conference platform and also received digital video lessons and exercises. To evaluate the effectiveness of the BCC program, mixed effects modeling was used to examine growth trajectories of anxiety and depression scores over the course of care. Results: Out of the total sample of 1496 clients, 75.9% (n=1136) demonstrated reliable improvement, and 88.6% (n=1326) recovered based on either the Generalized Anxiety Disorder-7 scale (anxiety) or Patient Health Questionnaire-9 (depression). On average, clients exhibited a significant decline in anxiety and depression symptoms during the initial weeks of coaching, with a continued decline over subsequent weeks at a lower rate. Engaging in a coaching session was associated with lower anxiety (b=–1.04) and depression (b=–0.79) symptoms in the same week, as well as lower anxiety (b=–0.74) and depression (b=–0.91) symptoms the following week (P<.001). Conclusions: The BCC program demonstrated strong outcomes in decreasing symptomology for clients presenting with moderate levels of anxiety and depression. When clients received coaching sessions, significant decreases in symptoms were observed, reflecting the importance of session attendance. Additionally, the steepest declines in symptoms tended to occur during the initial weeks of coaching, emphasizing the importance of client buy-in and early engagement. Collectively, these findings have implications for addressing unmet mental health care needs in a more accessible, cost-effective manner. %M 34673534 %R 10.2196/32100 %U https://mental.jmir.org/2021/10/e32100 %U https://doi.org/10.2196/32100 %U http://www.ncbi.nlm.nih.gov/pubmed/34673534 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 10 %P e29913 %T Six-Month Outcomes from the NEXit Junior Trial of a Text Messaging Smoking Cessation Intervention for High School Students: Randomized Controlled Trial With Bayesian Analysis %A Bendtsen,Marcus %A Bendtsen,Preben %A Müssener,Ulrika %+ Department of Health, Medicine and Caring Sciences, Linköping University, Building 511, Linköping, 58183, Sweden, 46 13286975, marcus.bendtsen@liu.se %K smoking %K cessation %K text messaging %K high school %K randomized controlled trial %K intervention %K student %K young adult %K teenager %K outcome %K Bayesian %K Sweden %K prevalence %K lifestyle %K behavior %D 2021 %7 21.10.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The prevalence of daily or occasional smoking among high school students in Sweden was approximately 20% in 2019, which is problematic since lifestyle behaviors are established in adolescence and track into adulthood. The Nicotine Exit (NEXit) Junior trial was conducted in response to a lack of evidence for the effects of text message smoking cessation interventions among high school students in Sweden. Objective: The aim of this study was to estimate the 3- and 6-month effects of a text messaging intervention among high school students in Sweden on smoking cessation outcomes. Methods: A 2-arm, single-blind randomized controlled trial was employed to estimate the effects of the intervention on smoking cessation in comparison to treatment as usual. Participants were recruited from high schools in Sweden using advertising and promotion by school staff from January 10, 2018, to January 10, 2019. Weekly or daily smokers who were willing to make a quit attempt were eligible for inclusion. Prolonged abstinence and point prevalence of smoking cessation were measured at 3 and 6 months after randomization. Results: Complete case analysis was possible on 57.9% (310/535) of the participants at 6 months, with no observed statistically significant effect on 5-month prolonged abstinence (odds ratio [OR] 1.27, 95% CI 0.73-2.20; P=.39) or 4-week smoking cessation (OR 1.42; 95% CI 0.83-2.46; P=.20). Sensitivity analyses using imputation yielded similar findings. Unplanned Bayesian analyses showed that the effects of the intervention were in the anticipated direction. The findings were limited by the risk of bias induced by high attrition (42.1%). The trial recruited high school students in a pragmatic setting and included both weekly and daily smokers; thus, generalization to the target population is more direct compared with findings obtained under more strict study procedures. Conclusions: Higher than expected attrition rates to follow-up 6 months after randomization led to null hypothesis tests being underpowered; however, unplanned Bayesian analyses found that the effects of the intervention were in the anticipated direction. Future trials of smoking cessation interventions targeting high school students should aim to prepare strategies for increasing retention to mid- and long-term follow-up. Trial Registration: IRCTN Registry ISRCTN15396225; https://www.isrctn.com/ISRCTN15396225 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-018-3028-2 %M 34673532 %R 10.2196/29913 %U https://mhealth.jmir.org/2021/10/e29913 %U https://doi.org/10.2196/29913 %U http://www.ncbi.nlm.nih.gov/pubmed/34673532 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 10 %P e30491 %T Learning About the Current State of Digital Mental Health Interventions for Canadian Youth to Inform Future Decision-Making: Mixed Methods Study %A Kemp,Jessica %A Chorney,Jill %A Kassam,Iman %A MacDonald,Julie %A MacDonald,Tara %A Wozney,Lori %A Strudwick,Gillian %+ Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, 1001 Queen St W, Toronto, ON, M6J 1H4, Canada, 1 416 535 8501, gillian.strudwick@camh.ca %K youth mental health %K digital mental health %K COVID-19 %K digital mental health interventions %K e-mental health %D 2021 %7 19.10.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The COVID-19 pandemic has increased the demand for youth mental health services in Canada as disruptions to clinical care continue to persist due to the risk of transmission and exposure to the virus. Digital mental health interventions, including web-based resources and mobile apps, have provided opportunities to support youth mental health remotely across Canada. There is a need to better understand how these digital interventions are being selected, recommended, and used in various regions across Canada. Objective: A national jurisdictional scan was completed to (1) determine what web-based programs, apps, and websites are promoted and licensed in Canada for youth mental health; (2) identify criteria and decision-making processes that Canadian jurisdictions use to select web-based programs, apps, and websites for youth mental health; and (3) identify upcoming trends, innovations, and digital mental health possibilities that are emerging in the youth sector. Methods: The aims of the jurisdictional scan were addressed through a review of related academic and grey literature; stakeholder interviews, including individuals involved in various areas of the youth mental health sector; and a social media review of pertinent Twitter content. Results: A total of 66 web-based resources and apps were identified for use by youth in Canada. 16 stakeholder interviews were completed and included discussions with researchers, clinicians, youth organizations, and others involved in digital interventions for youth mental health. These discussions identified a limited use of frameworks used to guide decision-making processes when selecting digital interventions. Many clinicians agreed on a similar set of eligibility requirements for youth mental health apps and digital resources, such as the evidence base and cultural relevance of the intervention. Stakeholders also identified upcoming trends and innovations in the youth digital mental health space, including artificial intelligence, digital phenotyping, and personalized therapy. Over 4 weeks, 2184 tweets were reviewed to identify and compare global and national trends and innovations involving digital mental health and youth. Key trends included the promotion of regional chat services as well as the effects of the COVID-19 pandemic on youth mental health and access to care. Conclusions: As organizations begin to plan for the delivery of mental health care following the pandemic, there are concerns about the sustainability of these digital mental health interventions as well as a need for services to be more informed by the experiences and preferences of youth. %M 34665141 %R 10.2196/30491 %U https://www.jmir.org/2021/10/e30491 %U https://doi.org/10.2196/30491 %U http://www.ncbi.nlm.nih.gov/pubmed/34665141 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 10 %P e26305 %T Detecting Parkinson Disease Using a Web-Based Speech Task: Observational Study %A Rahman,Wasifur %A Lee,Sangwu %A Islam,Md Saiful %A Antony,Victor Nikhil %A Ratnu,Harshil %A Ali,Mohammad Rafayet %A Mamun,Abdullah Al %A Wagner,Ellen %A Jensen-Roberts,Stella %A Waddell,Emma %A Myers,Taylor %A Pawlik,Meghan %A Soto,Julia %A Coffey,Madeleine %A Sarkar,Aayush %A Schneider,Ruth %A Tarolli,Christopher %A Lizarraga,Karlo %A Adams,Jamie %A Little,Max A %A Dorsey,E Ray %A Hoque,Ehsan %+ Department of Computer Science, University of Rochester, 250 Hutchinson Rd, Rochester, NY, 14620, United States, 1 5857487677, echowdh2@ur.rochester.edu %K Parkinson’s disease %K speech analysis %K improving access and equity in health care %K mobile phone %D 2021 %7 19.10.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Access to neurological care for Parkinson disease (PD) is a rare privilege for millions of people worldwide, especially in resource-limited countries. In 2013, there were just 1200 neurologists in India for a population of 1.3 billion people; in Africa, the average population per neurologist exceeds 3.3 million people. In contrast, 60,000 people receive a diagnosis of PD every year in the United States alone, and similar patterns of rising PD cases—fueled mostly by environmental pollution and an aging population—can be seen worldwide. The current projection of more than 12 million patients with PD worldwide by 2040 is only part of the picture given that more than 20% of patients with PD remain undiagnosed. Timely diagnosis and frequent assessment are key to ensure timely and appropriate medical intervention, thus improving the quality of life of patients with PD. Objective: In this paper, we propose a web-based framework that can help anyone anywhere around the world record a short speech task and analyze the recorded data to screen for PD. Methods: We collected data from 726 unique participants (PD: 262/726, 36.1% were women; non-PD: 464/726, 63.9% were women; average age 61 years) from all over the United States and beyond. A small portion of the data (approximately 54/726, 7.4%) was collected in a laboratory setting to compare the performance of the models trained with noisy home environment data against high-quality laboratory-environment data. The participants were instructed to utter a popular pangram containing all the letters in the English alphabet, “the quick brown fox jumps over the lazy dog.” We extracted both standard acoustic features (mel-frequency cepstral coefficients and jitter and shimmer variants) and deep learning–based embedding features from the speech data. Using these features, we trained several machine learning algorithms. We also applied model interpretation techniques such as Shapley additive explanations to ascertain the importance of each feature in determining the model’s output. Results: We achieved an area under the curve of 0.753 for determining the presence of self-reported PD by modeling the standard acoustic features through the XGBoost—a gradient-boosted decision tree model. Further analysis revealed that the widely used mel-frequency cepstral coefficient features and a subset of previously validated dysphonia features designed for detecting PD from a verbal phonation task (pronouncing “ahh”) influence the model’s decision the most. Conclusions: Our model performed equally well on data collected in a controlled laboratory environment and in the wild across different gender and age groups. Using this tool, we can collect data from almost anyone anywhere with an audio-enabled device and help the participants screen for PD remotely, contributing to equity and access in neurological care. %M 34665148 %R 10.2196/26305 %U https://www.jmir.org/2021/10/e26305 %U https://doi.org/10.2196/26305 %U http://www.ncbi.nlm.nih.gov/pubmed/34665148 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 4 %P e29739 %T A Novel Mobile Health App to Educate and Empower Young People With Type 1 Diabetes to Exercise Safely: Prospective Single-Arm Mixed Methods Pilot Study %A Shetty,Vinutha B %A Soon,Wayne H K %A Roberts,Alison G %A Fried,Leanne %A Roby,Heather C %A Smith,Grant J %A Fournier,Paul A %A Jones,Timothy W %A Davis,Elizabeth A %+ Department of Endocrinology and Diabetes, Perth Children's Hospital, 15 Hospital Avenue, Nedlands, Perth, 6009, Australia, 61 864562222, vinutha.shetty@health.wa.gov.au %K mobile health app %K exercise %K acT1ve %K type 1 diabetes %K young people %K blood glucose level %D 2021 %7 14.10.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Empowering young people with type 1 diabetes (T1D) to manage their blood glucose levels during exercise is a complex challenge faced by health care professionals due to the unpredictable nature of exercise and its effect on blood glucose levels. Mobile health (mHealth) apps would be useful as a decision-support aid to effectively contextualize a blood glucose result and take appropriate action to optimize glucose levels during and after exercise. A novel mHealth app acT1ve was recently developed, based on expert consensus exercise guidelines, to provide real-time support for young people with T1D during exercise. Objective: Our aim was to pilot acT1ve in a free-living setting to assess its acceptability and functionality, and gather feedback on the user experience before testing it in a larger clinical trial. Methods: A prospective single-arm mixed method design was used. Ten participants with T1D (mean age 17.7 years, SD 4.2 years; mean HbA1c, 54 mmol/mol, SD 5.5 mmol/mol [7.1%, SD 0.5%]) had acT1ve installed on their phones, and were asked to use the app to guide their exercise management for 6 weeks. At the end of 6 weeks, participants completed both a semistructured interview and the user Mobile Application Rating Scale (uMARS). All semistructured interviews were transcribed. Thematic analysis was conducted whereby interview transcripts were independently analyzed by 2 researchers to uncover important and relevant themes. The uMARS was scored for 4 quality subscales (engagement, functionality, esthetics, and information), and a total quality score was obtained from the weighted average of the 4 subscales. Scores for the 4 objective subscales were determined by the mean score of each of its individual questions. The perceived impact and subjective quality of acT1ve for each participant were calculated by averaging the scores of their related questions, but were not considered in the total quality score. All scores have a maximal possible value of 5, and they are presented as medians, IQRs, and ranges. Results: The main themes arising from the interview analysis were “increased knowledge,” “increased confidence to exercise,” and “suitability” for people who were less engaged in exercise. The uMARS scores for acT1ve were high (out of 5) for its total quality (median 4.3, IQR 4.2-4.6), engagement (median 3.9, IQR 3.6-4.2), functionality (median 4.8, IQR 4.5-4.8), information (median 4.6, IQR 4.5-4.8), esthetics (median 4.3, IQR 4.0-4.7), subjective quality (median 4.0, IQR 3.8-4.2), and perceived impact (median 4.3, IQR 3.6-4.5). Conclusions: The acT1ve app is functional and acceptable, with a high user satisfaction. The efficacy and safety of this app will be tested in a randomized controlled trial in the next phase of this study. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619001414101; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378373 %M 34647896 %R 10.2196/29739 %U https://diabetes.jmir.org/2021/4/e29739 %U https://doi.org/10.2196/29739 %U http://www.ncbi.nlm.nih.gov/pubmed/34647896 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 10 %P e25772 %T The Use of Task Shifting to Improve Treatment Engagement in an Internet-Based Mindfulness Intervention Among Chinese University Students: Randomized Controlled Trial %A Rodriguez,Marcus %A Eisenlohr-Moul,Tory A %A Weisman,Jared %A Rosenthal,M Zachary %+ Pitzer College, 1050 N Mills Ave, BN 205, Claremont, CA, 91711, United States, 1 9784605088, jweisman@pitzer.edu %K mindfulness %K mental health %K social support %K internet-based intervention %K treatment outcome %K university students %K smartphone %K mobile phone %D 2021 %7 13.10.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Traditional in-person psychotherapies are incapable of addressing global mental health needs. Use of computer-based interventions is one promising solution for closing the gap between the amount of global mental health treatment needed and received. Objective: Although many meta-analyses have provided evidence supporting the efficacy of self-guided, computer-based interventions, most report low rates of treatment engagement (eg, high attrition and low adherence). The aim of this study is to investigate the efficacy of an adjunctive treatment component that uses task shifting, wherein mental health care is provided by nonspecialist peer counselors to enhance engagement in an internet-based, self-directed, evidence-based mindfulness intervention among Chinese university students. Methods: From 3 universities across China, 54 students who reported at least mild stress, anxiety, or depression were randomly assigned to a 4-week internet-based mindfulness intervention (MIND) or to the intervention plus peer counselor support (MIND+), respectively. Be Mindful delivers all the elements of mindfulness-based cognitive therapy in an internet-based, 4-week course. Participants completed daily monitoring of mindfulness practice and mood, as well as baseline and posttreatment self-reported levels of depression, anxiety, stress, and trait mindfulness. We screened 56 volunteer peer counselor candidates who had no former training in the delivery of mental health services. Of these, 10 were invited to participate in a day-long training, and 4 were selected. Peer counselors were instructed to provide 6 brief (15-20 minute) sessions each week, to help encouraging participants to complete the internet-based intervention. Peer counselors received weekly web-based group supervision. Results: For both conditions, participation in the internet-based intervention was associated with significant improvements in mindfulness and mental health outcomes. The pre-post effect sizes (Cohen d) for mindfulness, depression, anxiety, and stress were 0.55, 0.95, 0.89, and 1.13, respectively. Participants assigned to the MIND+ (vs MIND) condition demonstrated significantly less attrition and more adherence, as indicated by a greater likelihood of completing posttreatment assessments (16/27, 59% vs 7/27, 26%; χ21=6.1; P=.01) and a higher percentage of course completion (72.6/100, 72.6% vs 50.7/100, 50.7%; t52=2.10; P=.04), respectively. No significant between-group differences in daily frequency and duration of mindfulness practice were observed. Multilevel logistic growth models showed that MIND+ participants reported significantly greater pre-post improvements in daily stress ratings (interaction estimate 0.39, SE 0.18; t317=2.29; P=.02) and depression (interaction estimate 0.38, SE 0.16; t330=2.37; P=.02) than those in the MIND condition. Conclusions: This study provides new insights into effective ways of leveraging technology and task shifting to implement large-scale mental health initiatives that are financially feasible, easily transportable, and quickly scalable in low-resource settings. The findings suggest that volunteer peer counselors receiving low-cost, low-intensity training and supervision may significantly improve participants’ indices of treatment engagement and mental health outcomes in an internet-based mindfulness intervention among Chinese university students. %M 34643532 %R 10.2196/25772 %U https://formative.jmir.org/2021/10/e25772 %U https://doi.org/10.2196/25772 %U http://www.ncbi.nlm.nih.gov/pubmed/34643532 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 10 %P e25622 %T Supporting the Mental Health Needs of Military Partners Through the Together Webinar Program: Pilot Randomized Controlled Trial %A Hendrikx,Laura Josephine %A Murphy,Dominic %+ Combat Stress, Tyrwhitt House, Oaklawn Road, Leatherhead, KT22 0BX, United Kingdom, 44 01372 587 017, dominic.murphy@combatstress.com %K mental health support %K online group-based support %K military partners %D 2021 %7 12.10.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: Despite an increased risk of psychological difficulties, there remains a lack of evidence-based support for the mental health needs of military partners. Objective: This study aims to investigate whether the Together Webinar Programme (TTP-Webinar), a 6-week structured, remote access group intervention would reduce military partners’ experience of common mental health difficulties and secondary trauma symptoms. Methods: A pilot randomized controlled trial was used to compare the TTP-Webinar intervention with a waitlist control. The sample was UK treatment-seeking veterans engaged in a mental health charity. A total of 196 military partners (1 male and 195 females; aged mean 42.28, SD 10.82 years) were randomly allocated to the intervention (n=97) or waitlist (n=99) condition. Outcome measures were self-reported measures of common mental health difficulties, secondary trauma symptoms, and overall quality of life rating. Results: Compared with the waitlist, military partners in the TTP-Webinar had reduced common mental health difficulties (P=.02) and secondary trauma symptoms (P=.001). However, there was no difference in quality-of-life ratings (P=.06). Conclusions: The results suggest that TTP-Webinar is an effective intervention to support the mental health difficulties of military partners. This study provides promising evidence that webinars may be an appropriate platform for providing group-based support. Trial Registration: ClinicalTrials.gov NCT05013398; https://clinicaltrials.gov/ct2/show/NCT05013398 %M 34636734 %R 10.2196/25622 %U https://mental.jmir.org/2021/10/e25622 %U https://doi.org/10.2196/25622 %U http://www.ncbi.nlm.nih.gov/pubmed/34636734 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 10 %P e29064 %T Development of a Theoretically Informed Web-Based Mind-Body Wellness Intervention for Patients With Primary Biliary Cholangitis: Formative Study %A Watt,Makayla %A Spence,John C %A Tandon,Puneeta %+ University of Alberta, 130-University Campus, Edmonton, AB, T6G2X8, Canada, 1 780 492 9844, ptandon@ualberta.ca %K liver disease %K meditation %K yoga %K breathwork %K behavior theory %K COM-B model %K behaviour change wheel %K behaviour change taxonomy %K internet %K digital %D 2021 %7 8.10.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Mind-body interventions have the potential to positively impact the symptom burden associated with primary biliary cholangitis (PBC). Interventions are more likely to be effective if they are informed by a theoretical framework. The Behaviour Change Wheel (BCW) and the behaviour change technique taxonomy version 1 (BCTv1) provide frameworks for intervention development. Objective: This study describes how theory has guided the development of a 12-week multicomponent mind-body wellness intervention for PBC. Methods: The steps involved in developing the BCW intervention included specifying the target behavior; explaining barriers and facilitators using the Capability, Opportunity, Motivation, and Behaviour and the theoretical domains framework; identifying intervention functions to target explanatory domains; and selecting relevant behavior change techniques to address intervention functions. Qualitative data from patients with inflammatory bowel disease using an earlier version of the program and feedback from a PBC patient advisory team were used to guide intervention development. Results: Barriers and facilitators to intervention participation associated with capability, opportunity, and motivation were identified. Intervention functions and behavior change techniques were identified to target each barrier and facilitator. Conclusions: The Peace Power Pack PBC intervention was developed to help individuals with PBC manage their symptom burden. The theoretical frameworks employed in this intervention provide direction on targeting antecedents of behavior and allow standardized reporting of intervention components. Trial Registration: ClinicalTrials.gov NCT04791527; https://clinicaltrials.gov/ct2/show/NCT04791527 %M 34623317 %R 10.2196/29064 %U https://formative.jmir.org/2021/10/e29064 %U https://doi.org/10.2196/29064 %U http://www.ncbi.nlm.nih.gov/pubmed/34623317 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 10 %P e26266 %T Conducting Digital Health Care Research: Document Analysis of Challenges Experienced During Intervention Development and Feasibility Study Setup of an Internet-Administered Intervention for Parents of Children Treated for Cancer %A Woodford,Joanne %A Karlsson,Mathilda %A Hagström,Josefin %A Hägg Sylvén,Ylva %A Norbäck,Kajsa %A Grönqvist,Helena %A von Essen,Louise %+ Healthcare Sciences and e-Health, Department of Women’s and Children’s Health, Uppsala University, MTC House, Dag Hammarskjölds väg 14B, Uppsala, 752 37, Sweden, 46 704250714, louise-von.essen@kbh.uu.se %K parents %K internet-administered cognitive behavior therapy %K low intensity CBT %K feasibility study %K challenges %K digital healthcare research %D 2021 %7 8.10.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: The design and conduct of research to develop, test, and evaluate complex health care interventions is challenging. Although the existing literature describes key challenges associated with the design and conduct of definitive (evaluation) trials, there is a lack of information concerning specific challenges associated with the intervention development phase and setup of feasibility studies. In particular, the literature is scarce concerning the challenges associated with conducting digital health care research, such as research on internet-administered interventions and research using digital features to support the execution of study procedures (eg, recruitment, consent, retention, and data collection and management). This study is conducted in the context of the intervention development and feasibility study setup phases of an internet-administered, guided, low-intensity cognitive behavioral therapy–based intervention for parents of children previously treated for cancer. Objective: The aim of this study is to explore the challenges experienced during the development phase of the internet-administered intervention and digital features to support the execution of the study procedures and a feasibility study setup. Methods: To explore the key challenges experienced, we conducted a document analysis of written records from all study meetings held by the research team (meeting minutes) between June 7, 2018, and January 10, 2020, guided by a thematic analysis approach. Furthermore, discussion groups with members of the research team were held to develop a more detailed understanding of the key challenges experienced. Methods and results are reported in accordance with the relevant items from the Standards for Reporting Qualitative Research checklist. Results: Six main themes were identified: decision-making and communication, expertise, external constraints, flexibility, planning and scheduling, and technical constraints. Conclusions: Significant challenges were experienced during the intervention development and setup phases of the feasibility study. Implications are discussed to inform future design, conduct, and planning of internet-administered intervention development and feasibility studies, especially within the context of digital health care research. %M 34433524 %R 10.2196/26266 %U https://formative.jmir.org/2021/10/e26266 %U https://doi.org/10.2196/26266 %U http://www.ncbi.nlm.nih.gov/pubmed/34433524 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 10 %P e31173 %T A Personalized, Interactive, Cognitive Behavioral Therapy–Based Digital Therapeutic (MODIA) for Adjunctive Treatment of Opioid Use Disorder: Development Study %A Meyer,Björn %A Utter,Geri-Lynn %A Hillman,Catherine %+ GAIA AG, Hans-Henny-Jahnn-Weg 53, Hamburg, 22085, Germany, 49 40351052 ext 31, bjoern.meyer@gaia-group.com %K MODIA %K opioid use disorder %K digital therapeutic %K cognitive behavioral therapy %K medication-assisted treatment %K Broca %D 2021 %7 8.10.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: Opioid use disorder (OUD) is characterized by the inability to control opioid use despite attempts to stop use and negative consequences to oneself and others. The burden of opioid misuse and OUD is a national crisis in the United States with substantial public health, social, and economic implications. Although medication-assisted treatment (MAT) has demonstrated efficacy in the management of OUD, access to effective counseling and psychosocial support is a limiting factor and a significant problem for many patients and physicians. Digital therapeutics are an innovative class of interventions that help prevent, manage, or treat diseases by delivering therapy using software programs. These applications can circumvent barriers to uptake, improve treatment adherence, and enable broad delivery of evidence-based management strategies to meet service gaps. However, few digital therapeutics specifically targeting OUD are available, and additional options are needed. Objective: To this end, we describe the development of the novel digital therapeutic MODIA. Methods: MODIA was developed by an international, multidisciplinary team that aims to provide effective, accessible, and sustainable management for patients with OUD. Although MODIA is aligned with principles of cognitive behavioral therapy, it was not designed to present any 1 specific treatment and uses a broad range of evidence-based behavior change techniques drawn from cognitive behavioral therapy, mindfulness, acceptance and commitment therapy, and motivational interviewing. Results: MODIA uses proprietary software that dynamically tailors content to the users’ responses. The MODIA program comprises 24 modules or “chats” that patients are instructed to work through independently. Patient responses dictate subsequent content, creating a “simulated dialogue” experience between the patient and program. MODIA also includes brief motivational text messages that are sent regularly to prompt patients to use the program and help them transfer therapeutic techniques into their daily routines. Thus, MODIA offers individuals with OUD a custom-tailored, interactive digital psychotherapy intervention that maximizes the personal relevance and emotional impact of the interaction. Conclusions: As part of a clinician-supervised MAT program, MODIA will allow more patients to begin psychotherapy concurrently with opioid maintenance treatment. We expect access to MODIA will improve the OUD management experience and provide sustainable positive outcomes for patients. %M 34623309 %R 10.2196/31173 %U https://mental.jmir.org/2021/10/e31173 %U https://doi.org/10.2196/31173 %U http://www.ncbi.nlm.nih.gov/pubmed/34623309 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 10 %P e28933 %T Virtual Education Program to Support Providers Caring for People With Intellectual and Developmental Disabilities During the COVID-19 Pandemic: Rapid Development and Evaluation Study %A Thakur,Anupam %A Pereira,Cheryl %A Hardy,Jenny %A Bobbette,Nicole %A Sockalingam,Sanjeev %A Lunsky,Yona %+ Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, 1025 Queen Street West, Toronto, ON, M6J 1H1, Canada, 1 6476185764, anupam.thakur@camh.ca %K COVID-19 %K coronavirus %K pandemic %K intellectual disability %K mental health %K community of practice %K ECHO, virtual %K capacity-building %D 2021 %7 7.10.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: People with intellectual and developmental disabilities are at increased health-related risk due to the COVID-19 pandemic. Virtual training programs that support providers in caring for the physical and mental health needs of this population, as well provide psychological support to the providers themselves, are needed during the pandemic. Objective: This paper describes the design, delivery, and evaluation of a virtual educational COVID-19–focused Extension for Community Healthcare Outcomes program to support providers during the COVID-19 pandemic in caring for the mental health of people with intellectual and developmental disabilities. Methods: A rapid design thinking approach was used to develop a 6-session program that incorporates mindfulness practice, a wellness check, COVID-19–related research and policy updates, a didactic presentation on a combination mental health and COVID-19 related topic, and a case-based discussion to encourage practical learning. We used the first 5 outcome levels of Moore’s evaluation framework—focusing on participation, satisfaction, learning, self-efficacy, and change in practice—which were rated (out of 5) by care providers from health and disability service sectors, as well as additional reflection measures about innovations to the program. Qualitative feedback from open-text responses from participants were analyzed using modified manifest content analysis. Results: A total of 104 care providers from health and disability service sectors participated in the program. High levels of engagement (81 participants per session on average) and satisfaction (overall satisfaction score: mean 4.31, SD 0.17) were observed. Self-efficacy (score improvement: 19.8%), support, and coping improved. Participants also rated the newly developed COVID-19 program and its innovative components highly. Open text feedback showed participants felt that the Extension for Community Healthcare Outcomes program expanded their knowledge and competency and created a sense of being part of a community of practice; provided value for the COVID-19 innovations; supported resource-sharing within and beyond program participants; and facilitated changes to participants’ approaches to client care in practice and increased participants’ confidence in supporting clients and families. Conclusions: The Extension for Community Healthcare Outcomes program is an effective model for capacity-building programs with a shared-learning approach. Future iterations should include targeted evaluation of long-term outcomes such as staff burnout. %M 34617917 %R 10.2196/28933 %U https://mental.jmir.org/2021/10/e28933 %U https://doi.org/10.2196/28933 %U http://www.ncbi.nlm.nih.gov/pubmed/34617917 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 10 %P e32544 %T Effectiveness of Telehealth Interventions for Women With Postpartum Depression: Systematic Review and Meta-analysis %A Zhao,Liuhong %A Chen,Jingfen %A Lan,Liuying %A Deng,Ni %A Liao,Yan %A Yue,Liqun %A Chen,Innie %A Wen,Shi Wu %A Xie,Ri-hua %+ Department of Nursing, The Seventh Affiliated Hospital, Southern Medical University, 28 Liguan Road, Lishui, Foshan, 528244, China, 86 189 2869 7126, xierihua928@hotmail.com %K telehealth %K postpartum depression %K anxiety %K meta-analysis %D 2021 %7 7.10.2021 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Postpartum depression (PPD) is a prevalent mental health problem with serious adverse consequences for affected women and their infants. Clinical trials have found that telehealth interventions for women with PPD result in increased accessibility and improved treatment effectiveness. However, no comprehensive synthesis of evidence from clinical trials by systematic review has been conducted. Objective: The aim of this study is to evaluate the effectiveness of telehealth interventions in reducing depressive symptoms and anxiety in women with PPD. To enhance the homogeneity and interpretability of the findings, this systematic review focuses on PPD measured by the Edinburgh Postnatal Depression Scale (EPDS). Methods: PubMed, The Cochrane Library, CINAHL, PsycINFO, CNKI, and Wanfang were electronically searched to identify randomized controlled trials (RCTs) on the effectiveness of telehealth interventions for women with PPD from inception to February 28, 2021. Data extraction and quality assessment were performed independently by two researchers. The quality of included studies was assessed using the Cochrane risk-of-bias tool, and meta-analysis was performed using RevMan 5.4 software. Results: Following the search, 9 RCTs with a total of 1958 women with PPD were included. The EPDS (mean difference=–2.99, 95% CI –4.52 to –1.46; P<.001) and anxiety (standardized mean difference=–0.39, 95% CI –0.67 to –0.12; P=.005) scores were significantly lower in the telehealth group compared with the control group. Significant subgroup differences were found in depressive symptoms according to the severity of PPD, telehealth technology, specific therapy, and follow-up time (P<.001). Conclusions: Telehealth interventions could effectively reduce the symptoms of depression and anxiety in women with PPD. However, better designed and more rigorous large-scale RCTs targeting specific therapies are needed to further explore the potential of telehealth interventions for PPD. Trial Registration: PROSPERO CRD42021258541; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=258541 %M 34617909 %R 10.2196/32544 %U https://mhealth.jmir.org/2021/10/e32544 %U https://doi.org/10.2196/32544 %U http://www.ncbi.nlm.nih.gov/pubmed/34617909 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 7 %N 4 %P e26226 %T Features That Middle-aged and Older Cancer Survivors Want in Web-Based Healthy Lifestyle Interventions: Qualitative Descriptive Study %A Ivankova,Nataliya V %A Rogers,Laura Q %A Herbey,Ivan I %A Martin,Michelle Y %A Pisu,Maria %A Pekmezi,Dorothy %A Thompson,Lieu %A Schoenberger-Godwin,Yu-Mei M %A Oster,Robert A %A Fontaine,Kevin %A Anderson,Jami L %A Kenzik,Kelly %A Farrell,David %A Demark-Wahnefried,Wendy %+ Department of Health Services Administration, University of Alabama at Birmingham, SHPB 569, 1720 2nd Avenue South, Birmingham, AL, 35294-1212, United States, 1 12059962422, nivankov@uab.edu %K cancer survivors %K diet %K physical activity %K lifestyle %K internet %K interventions %K qualitative %K eHealth %K mobile phone %D 2021 %7 6.10.2021 %9 Original Paper %J JMIR Cancer %G English %X Background: With the increasing number of older cancer survivors, it is imperative to optimize the reach of interventions that promote healthy lifestyles. Web-based delivery holds promise for increasing the reach of such interventions with the rapid increase in internet use among older adults. However, few studies have explored the views of middle-aged and older cancer survivors on this approach and potential variations in these views by gender or rural and urban residence. Objective: The aim of this study was to explore the views of middle-aged and older cancer survivors regarding the features of web-based healthy lifestyle programs to inform the development of a web-based diet and exercise intervention. Methods: Using a qualitative descriptive approach, we conducted 10 focus groups with 57 cancer survivors recruited from hospital cancer registries in 1 southeastern US state. Data were analyzed using inductive thematic and content analyses with NVivo (version 12.5, QSR International). Results: A total of 29 male and 28 female urban and rural dwelling Black and White survivors, with a mean age of 65 (SD 8.27) years, shared their views about a web-based healthy lifestyle program for cancer survivors. Five themes emerged related to program content, design, delivery, participation, technology training, and receiving feedback. Cancer survivors felt that web-based healthy lifestyle programs for cancer survivors must deliver credible, high-quality, and individually tailored information, as recommended by health care professionals or content experts. Urban survivors were more concerned about information reliability, whereas women were more likely to trust physicians’ recommendations. Male and rural survivors wanted information to be tailored to the cancer type and age group. Privacy, usability, interaction frequency, and session length were important factors for engaging cancer survivors with a web-based program. Female and rural participants liked the interactive nature and visual appeal of the e-learning sessions. Learning from experts, an attractive design, flexible schedule, and opportunity to interact with other cancer survivors in Facebook closed groups emerged as factors promoting program participation. Low computer literacy, lack of experience with web program features, and concerns about Facebook group privacy were important concerns influencing cancer survivors’ potential participation. Participants noted the importance of technology training, preferring individualized help to standardized computer classes. More rural cancer survivors acknowledged the need to learn how to use computers. The receipt of regular feedback about progress was noted as encouragement toward goal achievement, whereas women were particularly interested in receiving immediate feedback to stay motivated. Conclusions: Important considerations for designing web-based healthy lifestyle interventions for middle-aged and older cancer survivors include program quality, participants’ privacy, ease of use, attractive design, and the prominent role of health care providers and content experts. Cancer survivors’ preferences based on gender and residence should be considered to promote program participation. %M 34612832 %R 10.2196/26226 %U https://cancer.jmir.org/2021/4/e26226 %U https://doi.org/10.2196/26226 %U http://www.ncbi.nlm.nih.gov/pubmed/34612832 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 10 %P e25217 %T Feasibility of a Mobile Health App for Routine Outcome Monitoring and Feedback in SMART Recovery Mutual Support Groups: Stage 1 Mixed Methods Pilot Study %A Kelly,Peter J %A Beck,Alison K %A Deane,Frank P %A Larance,Briony %A Baker,Amanda L %A Hides,Leanne %A Manning,Victoria %A Shakeshaft,Anthony %A Neale,Joanne %A Kelly,John F %A Oldmeadow,Christopher %A Searles,Andrew %A Palazzi,Kerrin %A Lawson,Kenny %A Treloar,Carla %A Gray,Rebecca M %A Argent,Angela %A McGlaughlin,Ryan %+ School of Psychology, Faculty of Arts, Social Sciences and Humanities, University of Wollongong, Northfields Ave, Wollongong, 2522, Australia, 61 2 4239 2382, alisonbe@uow.edu.au %K mHealth %K SMART Recovery %K mutual support group %K mutual aid %K routine outcome monitoring %K treatment progress feedback %K addiction %K mobile phone %D 2021 %7 6.10.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Mutual support groups are an important source of long-term help for people impacted by addictive behaviors. Routine outcome monitoring (ROM) and feedback are yet to be implemented in these settings. SMART Recovery mutual support groups focus on self-empowerment and use evidence-based techniques (eg, motivational and behavioral strategies). Trained facilitators lead all SMART Recovery groups, providing an opportunity to implement ROM. Objective: The aim of this stage 1 pilot study is to explore the feasibility, acceptability, and preliminary outcomes of a novel, purpose-built mobile health ROM and feedback app (SMART Track) in mutual support groups coordinated by SMART Recovery Australia (SRAU) over 8 weeks. Methods: SMART Track was developed during phase 1 of this study using participatory design methods and an iterative development process. During phase 2, 72 SRAU group participants were recruited to a nonrandomized, prospective, single-arm trial of the SMART Track app. Four modes of data collection were used: ROM data directly entered by participants into the app; app data analytics captured by Amplitude Analytics (number of visits, number of unique users, visit duration, time of visit, and user retention); baseline, 2-, and 8-week follow-up assessments conducted through telephone; and qualitative telephone interviews with a convenience sample of study participants (20/72, 28%) and facilitators (n=8). Results: Of the 72 study participants, 68 (94%) created a SMART Track account, 64 (88%) used SMART Track at least once, and 42 (58%) used the app for more than 5 weeks. During week 1, 83% (60/72) of participants entered ROM data for one or more outcomes, decreasing to 31% (22/72) by the end of 8 weeks. The two main screens designed to provide personal feedback data (Urges screen and Overall Progress screen) were the most frequently visited sections of the app. Qualitative feedback from participants and facilitators supported the acceptability of SMART Track and the need for improved integration into the SRAU groups. Participants reported significant reductions between the baseline and 8- week scores on the Severity of Dependence Scale (mean difference 1.93, SD 3.02; 95% CI 1.12-2.73) and the Kessler Psychological Distress Scale-10 (mean difference 3.96, SD 8.31; 95% CI 1.75-6.17), but no change on the Substance Use Recovery Evaluator (mean difference 0.11, SD 7.97; 95% CI –2.02 to 2.24) was reported. Conclusions: Findings support the feasibility, acceptability, and utility of SMART Track. Given that sustained engagement with mobile health apps is notoriously difficult to achieve, our findings are promising. SMART Track offers a potential solution for ROM and personal feedback, particularly for people with substance use disorders who attend mutual support groups. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619000686101; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377336 International Registered Report Identifier (IRRID): RR2-10.2196/15113 %M 34612829 %R 10.2196/25217 %U https://www.jmir.org/2021/10/e25217 %U https://doi.org/10.2196/25217 %U http://www.ncbi.nlm.nih.gov/pubmed/34612829 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 10 %P e26104 %T A Web-Based Intervention (Germ Defence) to Increase Handwashing During a Pandemic: Process Evaluations of a Randomized Controlled Trial and Public Dissemination %A Miller,Sascha %A Ainsworth,Ben %A Weal,Mark %A Smith,Peter %A Little,Paul %A Yardley,Lucy %A Morrison,Leanne %+ Center for Clinical and Community Applications of Health Psychology, Department of Psychology, University of Southampton, Building 44 Highfield Campus, Southampton, SO17 1BJ, United Kingdom, 44 02380595000, sm2t07@soton.ac.uk %K behavior %K infection %K prevention %K respiratory tract infection %K internet %K evaluation studies %K pandemic %K COVID-19 %K transmission %K virus %K influenza %K respiratory %K intervention %K digital intervention %K dissemination %D 2021 %7 5.10.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Washing hands helps prevent transmission of seasonal and pandemic respiratory viruses. In a randomized controlled trial (RCT) during the swine flu outbreak, participants with access to a fully automated, digital intervention promoting handwashing reported washing their hands more often and experienced fewer respiratory tract infections than those without access to the intervention. Based on these findings, the intervention was adapted, renamed as “Germ Defence,” and a study was designed to assess the preliminary dissemination of the intervention to the general public to help prevent the spread of seasonal colds and flu. Objective: This study compares the process evaluations of the RCT and Germ Defence dissemination to examine (1) how web-based research enrollment procedures affected those who used the intervention, (2) intervention usage in the 2 contexts, and (3) whether increased intentions to wash hands are replicated once disseminated. Methods: The RCT ran between 2010 and 2012 recruiting participants offline from general practices, with restricted access to the intervention (N=9155). Germ Defence was disseminated as an open access website for use by the general public from 2016 to 2019 (N=624). The process evaluation plan was developed using Medical Research Council guidance and the framework for Analyzing and Measuring Usage and Engagement Data. Both interventions contained a goal-setting section where users self-reported current and intended handwashing behavior across 7 situations. Results: During web-based enrolment, 54.3% (17,511/32,250) of the RCT participants dropped out of the study compared to 36.5% (358/982) of Germ Defence users. Having reached the start of the intervention, 93.8% (8586/9155) of RCT users completed the core section, whereas 65.1% (406/624) of Germ Defence users reached the same point. Users across both studies selected to increase their handwashing in 5 out of 7 situations, including before eating snacks (RCT mean difference 1.040, 95% CI 1.016-1.063; Germ Defence mean difference 0.949, 95% CI 0.766-1.132) and after blowing their nose, sneezing, or coughing (RCT mean difference 0.995, 95% CI 0.972-1.019; Germ Defence mean difference 0.842, 95% CI 0.675-1.008). Conclusions: By comparing the preliminary dissemination of Germ Defence to the RCT, we were able to examine the potential effects of the research procedures on uptake and attrition such as the sizeable dropout during the RCT enrolment procedure that may have led to a more motivated sample. The Germ Defence study highlighted the points of attrition within the intervention. Despite sample bias in the trial context, the intervention replicated increases in intentions to handwash when used “in the wild.” This preliminary dissemination study informed the adaptation of the intervention for the COVID-19 health emergency, and it has now been disseminated globally. Trial Registration: ISRCTN Registry ISRCTN75058295; https://www.isrctn.com/ISRCTN75058295 %M 34519661 %R 10.2196/26104 %U https://www.jmir.org/2021/10/e26104 %U https://doi.org/10.2196/26104 %U http://www.ncbi.nlm.nih.gov/pubmed/34519661 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 7 %N 4 %P e25464 %T Characteristics of Participants and Nonparticipants in a Blended Internet-Based Physical Activity Trial for Breast and Prostate Cancer Survivors: Cross-sectional Study %A vd Wiel,Hester J %A Stuiver,Martijn M %A May,Anne M %A van Grinsven,Susan %A Benink,Marlou F A %A Aaronson,Neil K %A Oldenburg,Hester S A %A van der Poel,Henk G %A van Harten,Wim H %A Groen,Wim G %+ Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam, Netherlands, 31 0205129111, w.v.harten@nki.nl %K internet-based intervention %K physical activity %K nonparticipants %K breast cancer survivors %K prostate cancer survivors %K RCT %D 2021 %7 5.10.2021 %9 Original Paper %J JMIR Cancer %G English %X Background: As the number of cancer survivors is increasing, it is important to be able to offer exercise and physical activity (PA)–promoting interventions that are both effective and reasonably accessible. Internet-based interventions are typically less expensive and more accessible alternatives to on-site supervised interventions. Currently, little is known about the characteristics of nonparticipants in PA promotion trials in the cancer survivorship setting, both in general and specifically in trials using internet-supported interventions. Objective: This study aims to gain insight into the characteristics associated with nonparticipation in a blended internet-based supported intervention trial to promote PA. Methods: Breast and prostate cancer survivors, 3-36 months after primary curative treatment, were invited to participate in the PABLO trial; this trial compared an internet-based intervention to enhance PA levels, with or without additional support from a physical therapist, to usual care. Participants and nonparticipants were asked to complete a comprehensive questionnaire assessing sociodemographics, fatigue, and health-related quality of life. Baseline data for participants and nonparticipants were compared using the independent Student t test and chi-square test. Results: The inclusion rate in the trial was 11.03% (137/1242). Of the nonparticipants, 13.95% (154/1104) completed the questionnaire. Participants were more highly educated (P=.04), had a paid job less often (P=.03), and were on sick leave more often (P=.03). They reported less PA per week, both moderate (P=.03) and vigorous (P<.01), before diagnosis and during leisure time (P<.01, effect size [ES]=0.44). They reported a significantly lower stage of change (P≤.01), lower self-efficacy (P<.01, ES=0.61), perceived barriers to PA (P<.01, ES=0.54), and more general fatigue (P<.01, ES=0.60). Participants reported lower health-related quality of life for most domains (ES ranging from 0.34 for mental health to 0.48 for social functioning). No significant differences were found for other sociodemographics, mood state, or attitudes toward or perceived social support for PA. Conclusions: The participants who self-selected for trial participation reported lower PA levels before diagnosis and a stronger need for support compared with nonparticipants. The trial thus included those patients who might benefit the most from internet-based supportive PA interventions. Trial Registration: Netherlands trial register NTR6911; https://www.trialregister.nl/trial/6733 %M 34609311 %R 10.2196/25464 %U https://cancer.jmir.org/2021/4/e25464 %U https://doi.org/10.2196/25464 %U http://www.ncbi.nlm.nih.gov/pubmed/34609311 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 10 %P e15519 %T Assessing the Acceptability and Feasibility of a Web-Based Screening for Psychoactive Substance Users Among a French Sample of University Students and Workers: Mixed Methods Prospective Study %A Anthoine,Emmanuelle %A Caillon,Julie %A Deparis,Xavier %A Blanche,Michel %A Lebeaupin,Maxime %A Brochard,Marc-Antoine %A Venisse,Jean-Luc %A Moret,Leïla %+ PHU11 Public Health Department, Centre Hospitalier Universitaire (CHU) de Nantes, Hopital Saint-Jacques, 85 Rue Saint-Jacques, Nantes, 44093, France, 33 2 40 84 69 24, lmoret@chu-nantes.fr %K feasibility study %K preventive medicine %K addiction %K screening and brief intervention %K web-based app %D 2021 %7 1.10.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Early detection in the prevention of addictive behaviors remains a complex question in practice for most first-line health care workers (HCWs). Several prevention measures have successfully included a screening stage followed by a brief intervention in case of risk-related use or referral to an addiction center for problematic use. Whereas early detection is highly recommended by the World Health Organization, it is not usually performed in practice. Objective: The aim of this study was to assess the acceptability and feasibility of a web-based app, called Pulsio Santé, for health service users and first-line prevention HCW and to carry out an exhaustive process of early detection of psychoactive substance use behaviors. Methods: A mixed methods prospective study was conducted in 2 departments: HCWs from the regional occupational health department and from the university department of preventive medicine dedicated to students were invited to participate. Participants 18 years or older who had been seen in 2017 by a HCW from one of the departments were eligible. The study procedure comprised 5 phases: (1) inclusion of the participants after a face-to-face consultation with an HCW; (2) reception of a text message by participants on their smartphone or by email; (3) self-assessment by participants regarding their substance use with the Pulsio Santé app; (4) if participants agreed, transfer of the results to the HCW; and (5) if participants declined, a message to invite them to get in touch with their general practitioner should the assessment detect a risk. Several feasibility and acceptability criteria were assessed by an analysis of a focus group with the HCW that explored 4 themes (usefulness and advantages, problems and limitations, possible improvements, and finally, integration into routine practice). Results: A total of 1474 people were asked to participate, with 42 HCWs being involved. The percentage of people who agreed to receive a text message or an email, which was considered as the first level of acceptability, was 79.17% (1167/1474). The percentage of participants who clicked on the self-assessment link, considered as the second level of acceptability, was 60.24% (703/1167). The percentage of participants who completed their self-evaluation entirely, which was considered as the first level of feasibility, was 76.24% (536/703). The percentage of participants who shared the results of their evaluation with the HCWs, considered as the second level of feasibility, was 79.48% (426/536). The qualitative study showed that there were obstacles on the side of HCWs in carrying out the recommended interventions for people at risk based on their online screening, such as previous training or adaptations in accordance with specific populations. Conclusions: Quantitative results showed good acceptability and feasibility of the Pulsio Santé app by users and HCWs. There is a need for further studies more directly focused on the limitations highlighted by the qualitative results. %M 34596571 %R 10.2196/15519 %U https://formative.jmir.org/2021/10/e15519 %U https://doi.org/10.2196/15519 %U http://www.ncbi.nlm.nih.gov/pubmed/34596571 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e26418 %T Psychoeducational Messaging to Reduce Alcohol Use for College Students With Type 1 Diabetes: Internet-Delivered Pilot Trial %A Wisk,Lauren E %A Magane,Kara M %A Nelson,Eliza B %A Tsevat,Rebecca K %A Levy,Sharon %A Weitzman,Elissa R %+ Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine, University of California Los Angeles, 1100 Glendon Ave, Suite 850, Los Angeles, CA, 90024, United States, 1 3102675308, lwisk@mednet.ucla.edu %K adolescent %K young adult %K diabetes mellitus %K type 1 %K binge drinking %K alcohol drinking %K self care %K risk-taking %K universities %K students %K attitude %K mobile phone %D 2021 %7 30.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: College environments promote high-volume or binge alcohol consumption among youth, which may be especially harmful to those with type 1 diabetes (T1D). Little is known about the acceptability and effectiveness of interventions targeting reduced alcohol use by college students with T1D, and it is unclear whether intervention framing (specifically, the narrator of intervention messages) matters with respect to affecting behavior change. Interventions promoted by peer educators may be highly relatable and socially persuasive, whereas those delivered by clinical providers may be highly credible and motivating. Objective: The aim of this study is to determine the acceptability and impacts of an alcohol use psychoeducational intervention delivered asynchronously through web-based channels to college students with T1D. The secondary aim is to compare the impacts of two competing versions of the intervention that differed by narrator (peer vs clinician). Methods: We recruited 138 college students (aged 17-25 years) with T1D through web-based channels and delivered a brief intervention to participants randomly assigned to 1 of 2 versions that differed only with respect to the audiovisually recorded narrator. We assessed the impacts of the exposure to the intervention overall and by group, comparing the levels of alcohol- and diabetes-related knowledge, perceptions, and use among baseline, immediately after the intervention, and 2 weeks after intervention delivery. Results: Of the 138 enrolled participants, 122 (88.4%) completed all follow-up assessments; the participants were predominantly women (98/122, 80.3%), were White non-Hispanic (102/122, 83.6%), and had consumed alcohol in the past year (101/122, 82.8%). Both arms saw significant postintervention gains in the knowledge of alcohol’s impacts on diabetes-related factors, health-protecting attitudes toward drinking, and concerns about drinking. All participants reported significant decreases in binge drinking 2 weeks after the intervention (21.3%; odds ratio 0.48, 95% CI 0.31-0.75) compared with the 2 weeks before the intervention (43/122, 35.2%). Changes in binge drinking after the intervention were affected by changes in concerns about alcohol use and T1D. Those who viewed the provider narrator were significantly more likely to rate their narrator as knowledgeable and trustworthy; there were no other significant differences in intervention effects by the narrator. Conclusions: The intervention model was highly acceptable and effective at reducing self-reported binge drinking at follow-up, offering the potential for broad dissemination and reach given the web-based format and contactless, on-demand content. Both intervention narrators increased knowledge, improved health-protecting attitudes, and increased concerns regarding alcohol use. The participants’ perceptions of expertise and credibility differed by narrator. Trial Registration: ClinicalTrials.gov NCT02883829; https://clinicaltrials.gov/ct2/show/NCT02883829 International Registered Report Identifier (IRRID): RR2-10.1177/1932296819839503 %M 34591022 %R 10.2196/26418 %U https://www.jmir.org/2021/9/e26418 %U https://doi.org/10.2196/26418 %U http://www.ncbi.nlm.nih.gov/pubmed/34591022 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e25837 %T Development, Feasibility, Acceptability, and Utility of an Expressive Speech-Enabled Digital Health Agent to Deliver Online, Brief Motivational Interviewing for Alcohol Misuse: Descriptive Study %A Boustani,Maya %A Lunn,Stephanie %A Visser,Ubbo %A Lisetti,Christine %+ Department of Psychology, Loma Linda University, 11130 Anderson St, Suite 117, Loma Linda, CA, 92350, United States, 1 909 558 7680, mboustani@llu.edu %K digital health agent %K virtual health assistant %K online intervention %K alcohol abuse %K brief intervention %K motivational interviewing %K intelligent virtual agent %K embodied conversational agent %D 2021 %7 29.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital health agents — embodied conversational agents designed specifically for health interventions — provide a promising alternative or supplement to behavioral health services by reducing barriers to access to care. Objective: Our goals were to (1) develop an expressive, speech-enabled digital health agent operating in a 3-dimensional virtual environment to deliver a brief behavioral health intervention over the internet to reduce alcohol use and to (2) understand its acceptability, feasibility, and utility with its end users. Methods: We developed an expressive, speech-enabled digital health agent with facial expressions and body gestures operating in a 3-dimensional virtual office and able to deliver a brief behavioral health intervention over the internet to reduce alcohol use. We then asked 51 alcohol users to report on the digital health agent acceptability, feasibility, and utility. Results: The developed digital health agent uses speech recognition and a model of empathetic verbal and nonverbal behaviors to engage the user, and its performance enabled it to successfully deliver a brief behavioral health intervention over the internet to reduce alcohol use. Descriptive statistics indicated that participants had overwhelmingly positive experiences with the digital health agent, including engagement with the technology, acceptance, perceived utility, and intent to use the technology. Illustrative qualitative quotes provided further insight about the potential reach and impact of digital health agents in behavioral health care. Conclusions: Web-delivered interventions delivered by expressive, speech-enabled digital health agents may provide an exciting complement or alternative to traditional one-on-one treatment. They may be especially helpful for hard-to-reach communities with behavioral workforce shortages. %M 34586074 %R 10.2196/25837 %U https://www.jmir.org/2021/9/e25837 %U https://doi.org/10.2196/25837 %U http://www.ncbi.nlm.nih.gov/pubmed/34586074 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 9 %P e30305 %T Effectiveness of an Internet-Based Machine-Guided Stress Management Program Based on Cognitive Behavioral Therapy for Improving Depression Among Workers: Protocol for a Randomized Controlled Trial %A Kawakami,Norito %A Imamura,Kotaro %A Watanabe,Kazuhiro %A Sekiya,Yuki %A Sasaki,Natsu %A Sato,Nana %A , %+ Department of Mental Health, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 1130033, Japan, 81 358413521, nkawakami@m.u-tokyo.ac.jp %K deep learning %K unguided intervention %K universal prevention %K workplace %K depression %K machine learning %D 2021 %7 29.9.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: The effect of an unguided internet-based cognitive behavioral therapy (iCBT) stress management program on depression may be enhanced by applying artificial intelligence (AI) technologies to guide participants adopting the program. Objective: The aim of this study is to describe a research protocol to investigate the effect of a newly developed iCBT stress management program adopting AI technologies on improving depression among healthy workers during the COVID-19 pandemic. Methods: This study is a two-arm, parallel, randomized controlled trial. Participants (N=1400) will be recruited, and those who meet the inclusion criteria will be randomly allocated to the intervention or control (treatment as usual) group. A 6-week, six-module, internet-based stress management program, SMART-CBT, has been developed that includes machine-guided exercises to help participants acquire CBT skills, and it applies machine learning and deep learning technologies. The intervention group will participate in the program for 10 weeks. The primary outcome, depression, will be measured using the Beck Depression Inventory II at baseline and 3- and 6-month follow-ups. A mixed model repeated measures analysis will be used to test the intervention effect (group × time interactions) in the total sample (universal prevention) on an intention-to-treat basis. Results: The study was at the stage of recruitment of participants at the time of submission. The data analysis related to the primary outcome will start in January 2022, and the results might be published in 2022 or 2023. Conclusions: This is the first study to investigate the effectiveness of a fully automated machine-guided iCBT program for improving subthreshold depression among workers using a randomized controlled trial design. The study will explore the potential of a machine-guided stress management program that can be disseminated online to a large number of workers with minimal cost in the post–COVID-19 era. Trial Registration: UMIN Clinical Trials Registry(UMIN-CTR) UMIN000043897; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050125 International Registered Report Identifier (IRRID): PRR1-10.2196/30305 %M 34460414 %R 10.2196/30305 %U https://www.researchprotocols.org/2021/9/e30305 %U https://doi.org/10.2196/30305 %U http://www.ncbi.nlm.nih.gov/pubmed/34460414 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e29412 %T Just-in-Time Adaptive Mechanisms of Popular Mobile Apps for Individuals With Depression: Systematic App Search and Literature Review %A Teepe,Gisbert W %A Da Fonseca,Ashish %A Kleim,Birgit %A Jacobson,Nicholas C %A Salamanca Sanabria,Alicia %A Tudor Car,Lorainne %A Fleisch,Elgar %A Kowatsch,Tobias %+ Centre for Digital Health Interventions, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, Zurich, 8092, Switzerland, 41 76 419 09 91, gteepe@ethz.ch %K depression %K digital mental health %K smartphone applications %K just-in-time adaptive interventions %K effectiveness %K mobile phone %D 2021 %7 28.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The number of smartphone apps that focus on the prevention, diagnosis, and treatment of depression is increasing. A promising approach to increase the effectiveness of the apps while reducing the individual’s burden is the use of just-in-time adaptive intervention (JITAI) mechanisms. JITAIs are designed to improve the effectiveness of the intervention and reduce the burden on the person using the intervention by providing the right type of support at the right time. The right type of support and the right time are determined by measuring the state of vulnerability and the state of receptivity, respectively. Objective: The aim of this study is to systematically assess the use of JITAI mechanisms in popular apps for individuals with depression. Methods: We systematically searched for apps addressing depression in the Apple App Store and Google Play Store, as well as in curated lists from the Anxiety and Depression Association of America, the United Kingdom National Health Service, and the American Psychological Association in August 2020. The relevant apps were ranked according to the number of reviews (Apple App Store) or downloads (Google Play Store). For each app, 2 authors separately reviewed all publications concerning the app found within scientific databases (PubMed, Cochrane Register of Controlled Trials, PsycINFO, Google Scholar, IEEE Xplore, Web of Science, ACM Portal, and Science Direct), publications cited on the app’s website, information on the app’s website, and the app itself. All types of measurements (eg, open questions, closed questions, and device analytics) found in the apps were recorded and reviewed. Results: None of the 28 reviewed apps used JITAI mechanisms to tailor content to situations, states, or individuals. Of the 28 apps, 3 (11%) did not use any measurements, 20 (71%) exclusively used self-reports that were insufficient to leverage the full potential of the JITAIs, and the 5 (18%) apps using self-reports and passive measurements used them as progress or task indicators only. Although 34% (23/68) of the reviewed publications investigated the effectiveness of the apps and 21% (14/68) investigated their efficacy, no publication mentioned or evaluated JITAI mechanisms. Conclusions: Promising JITAI mechanisms have not yet been translated into mainstream depression apps. Although the wide range of passive measurements available from smartphones were rarely used, self-reported outcomes were used by 71% (20/28) of the apps. However, in both cases, the measured outcomes were not used to tailor content and timing along a state of vulnerability or receptivity. Owing to this lack of tailoring to individual, state, or situation, we argue that the apps cannot be considered JITAIs. The lack of publications investigating whether JITAI mechanisms lead to an increase in the effectiveness or efficacy of the apps highlights the need for further research, especially in real-world apps. %M 34309569 %R 10.2196/29412 %U https://www.jmir.org/2021/9/e29412 %U https://doi.org/10.2196/29412 %U http://www.ncbi.nlm.nih.gov/pubmed/34309569 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e20520 %T Use of a Mobile Lifestyle Intervention App as an Early Intervention for Adolescents With Obesity: Single-Cohort Study %A Chew,Chu Shan Elaine %A Davis,Courtney %A Lim,Jie Kai Ethel %A Lim,Chee Meng Micheal %A Tan,Yi Zhen Henny %A Oh,Jean Yin %A Rajasegaran,Kumudhini %A Chia,Yong Hwa Michael %A Finkelstein,Eric Andrew %+ KK Women's and Children's Hospital, 100 Bukit Timah Road, Singapore, 229899, Singapore, 65 62255554, elaine.chew.c.s@singhealth.com.sg %K pediatric obesity %K mobile health %K apps %K health behavior %K mHealth %K obesity %K adolescent %K lifestyle %K well-being %K mobile phone %D 2021 %7 28.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Effective, resource-efficient treatment is urgently needed to address the high rates of pediatric and adolescent obesity. This need has been accelerated by the COVID-19 pandemic. The use of a mobile health tool as an early intervention before a clinic-based multidisciplinary weight management program could be an effective treatment strategy that is appropriate during a pandemic. Objective: This study aims to assess the effectiveness of and adolescent engagement with a mobile app–based lifestyle intervention program as an early intervention before enrollment in a clinic-based multidisciplinary weight management program. Methods: This prospective single-cohort study involved adolescents, aged 10-16 years, who were overweight and obese (defined as BMI percentile above the 85th percentile). Participants used the mobile Kurbo app as an early intervention before enrolling in a clinic-based multidisciplinary weight management program. Kurbo’s health coaches provided weekly individual coaching informed by a model of supportive accountability via video chat, and participants self-monitored their health behavior. The implementation of Kurbo as an early intervention was evaluated using the reach, effectiveness, adoption, implementation, and maintenance framework by reach (number who consented to participate out of all patients approached), implementation (Kurbo engagement and evaluation), and effectiveness as measured by the primary outcome of the BMI z-score at 3 months. Secondary outcome measures included changes in body fat percentage, nutrition and physical activity levels, and quality of life at 3 months. Maintenance was defined as the outcome measures at 6-month follow-up. Results: Of the 73 adolescents who were approached for enrollment, 40 (55%) of adolescents were recruited. The mean age was 13.8 (SD 1.7) years, and the mean BMI z-score was 2.07 (SD 0.30). In the multiethnic Asian sample, 83% (33/40) of the participants had household incomes below the national median. Kurbo engagement was high, with 83% (33/40) of participants completing at least 7 coaching sessions. In total, 78% (18/23) of participants rated the app as good to excellent and 70% (16/23) stated that they would recommend it to others. There were no statistically significant changes in BMI z-scores at 3 months (P=.19) or 6 months (P=.27). Participants showed statistically significant improvements in measured body fat percentage, self-reported quality of life, and self-reported caloric intake from the 3-day food diaries at 3 and 6 months. Conclusions: The use of Kurbo before enrollment in an outpatient multidisciplinary clinical care intervention is a feasible strategy to expand the reach of adolescent obesity management services to a low-income and racially diverse population. Although there was no significant change in BMI z-scores, the use of Kurbo as an early intervention could help to improve quality of life and reduce body fat percentage and total caloric intake. %M 34581672 %R 10.2196/20520 %U https://www.jmir.org/2021/9/e20520 %U https://doi.org/10.2196/20520 %U http://www.ncbi.nlm.nih.gov/pubmed/34581672 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e19794 %T Patients’ Perspectives on the Usability of a Blended Approach to an Integrated Intervention for Patients With Medically Unexplained Physical Symptoms: Mixed Methods Study %A Toonders,Suze Adriana Johanna %A van Westrienen,Paula Elisabeth %A Konings,Sophie %A Nieboer,Marianne E %A Veenhof,Cindy %A Pisters,Martijn F %+ Department of Health Innovation and Technology, Fontys University of Applied Sciences, Dominee Theodor Fliednerstraat 2, Eindhoven, 5600 AH, Netherlands, 31 641621939, s.a.j.toonders@umcutrecht.nl %K usability %K medically unexplained physical symptoms %K blended care %D 2021 %7 28.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Medically unexplained physical symptoms are physical symptoms, such as pain, fatigue, and dizziness, that persist for more than a few weeks and cannot be explained after adequate medical examination. Treatment for preventing the chronicity of symptoms is recommended. A promising approach is identifying patients who are at risk and subsequently offering a blended care intervention that focuses on promoting self-management while using eHealth as a supportive tool. When these interventions match with a patient’s expectations, their effectiveness grows. Objective: This study aimed to obtain more insights into usability from the patient perspective to improve future interventions. Methods: A mixed methods design (ie, the use of qualitative and quantitative data) was used. Through semistructured interviews, in-depth insights were gained into patients’ perspectives on usability. The analysis process was continuous and iterative. Data were synthesized and categorized into different themes. The System Usability Scale, which measures the usability of a system, was used to compare participants that found usability to be low, medium, or high. This study was approved by the Medical Ethical Committee Utrecht (approval number: 17-391/C). Results: Saturation was reached after interviewing 13 participants. The following four themes emerged from the interviews: motivations and expectations prior to participating in the program, the applicability of e-coaching, the role of health care professionals, and the integrated design of the blended approach. Conclusions: The successful implementation of integrated blended care interventions based on patients’ perspectives requires matching treatments to patients’ individual situations and motivations. Furthermore, personalizing the relative frequency of face-to-face appointments and e-coaching can improve usability. %M 34581674 %R 10.2196/19794 %U https://www.jmir.org/2021/9/e19794 %U https://doi.org/10.2196/19794 %U http://www.ncbi.nlm.nih.gov/pubmed/34581674 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 9 %P e20892 %T Effectiveness of Using Mobile Technology to Improve Cognitive and Social Skills Among Individuals With Autism Spectrum Disorder: Systematic Literature Review %A Leung,Phil Wai Shun %A Li,Shirley Xin %A Tsang,Carmen Sze Oi %A Chow,Bellavista Long Ching %A Wong,William Chi Wai %+ Department of Family Medicine and Primary Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 3/F, Ap Lei Chau Clinic, 161 Main Street, Ap Lei Chau, Hong Kong, China (Hong Kong), 852 25185657, wongwcw@hku.hk %K autism spectrum disorder %K mobile devices %K systematic review %K randomized controlled trial %K social skills %K cognitive skills %D 2021 %7 28.9.2021 %9 Review %J JMIR Ment Health %G English %X Background: Mobile technology has become a necessity in the lives of people in many countries. Its characteristics and advantages also make it a potential medium of intervention for people with autism spectrum disorder (ASD). Objective: The objective of this review was to evaluate previous evidence, obtained in randomized controlled trials (RCTs), on the effectiveness of using mobile devices as the medium of intervention targeting social and cognitive skills among individuals with ASD. Methods: Literature search was conducted on electronic databases including Medline, PsycInfo, PsycArticles, Education Resources Information Centre, and Social Science Citation Index. Only RCTs published in English and after year 2000 were included for this review. Data extraction was carried out by 2 independent reviewers using constant comparative methods. Results: Totally 10 RCTs were identified. Most of the findings indicated that mobile devices could be an effective medium of intervention for people with ASD, among which 6 indicated significant intervention effects and 2 showed mixed findings. Effective intervention was more likely to be achieved in the studies that recruited older participants (aged over 9 years), targeting practical skills that could be readily applied in real life, or using pictures or materials that were highly relevant in daily life in the apps or mobile devices. Furthermore, the use of mobile devices was also reported to promote participation in the intervention among individuals with ASD. Conclusions: The results suggested that mobile devices could be a promising means for the delivery of interventions targeting people with ASD. Although including a small number of studies was a limitation of this review, the results provided useful implications for designing effective mobile technology–assisted interventions for the ASD population in future studies. %M 34581681 %R 10.2196/20892 %U https://mental.jmir.org/2021/9/e20892 %U https://doi.org/10.2196/20892 %U http://www.ncbi.nlm.nih.gov/pubmed/34581681 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e28355 %T Effect of a Brief Web-Based Educational Intervention on Willingness to Consider Human Papillomavirus Vaccination for Children in Japan: Randomized Controlled Trial %A Suzuki,Yukio %A Sukegawa,Akiko %A Ueda,Yutaka %A Sekine,Masayuki %A Enomoto,Takayuki %A Miyagi,Etsuko %+ Department of Obstetrics and Gynecology, Graduate School of Medicine, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan, 81 45 787 2800, yetii@yokohama-cu.ac.jp %K human papillomavirus %K human papillomavirus vaccination %K behavioral insights %K behavioral change %K web-based randomized controlled trial %D 2021 %7 27.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The human papillomavirus (HPV) vaccination rate in Japan has fallen to nearly zero since the suspension of governmental proactive recommendations in 2013, owing to the development of purported adverse events. Objective: This study aimed to evaluate the effects of a brief web-based educational intervention using the theory of behavioral insights on the willingness of adults to consider the HPV vaccine for their daughters and sons. Methods: We recruited 1660 participants aged 20 years or older in March 2018 via a webpage and provided them with a 10-item questionnaire related to the following aspects: awareness regarding HPV infection and vaccination, willingness for immunization, and actions for prevention. We randomly stratified participants based on sex and age with or without a brief educational intervention involving scientific information presented in an easy-to-read format. Results: Only 484 (29.2%) of the respondents were aware of the benefits of HPV vaccination. Although only 352 (21.2%) of the respondents displayed a willingness for immunization of their daughters, there were 40 (4.8%) more respondents in the intervention group with this willingness (adjusted odds ratio [aOR] 1.32, 95% CI 1.04-1.69). In a subanalysis, the willingness toward vaccination for daughters in men was significantly higher in the intervention group (aOR 1.46, 95% CI 1.05-2.02). However, such a difference was not observed among women (aOR 1.20, 95% CI 0.83-1.73). Conclusions: This study suggests that a brief web-based educational intervention increases the willingness of adults to consider the HPV vaccine for their children, especially among men. Thus, providing adequate information to men may be a useful strategy to improve the currently low rates of HPV vaccination. Trial Registration: UMIN Clinical Trials Registry UMIN000049745 (UMIN-CTR); https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049745 %M 34569941 %R 10.2196/28355 %U https://www.jmir.org/2021/9/e28355 %U https://doi.org/10.2196/28355 %U http://www.ncbi.nlm.nih.gov/pubmed/34569941 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e26545 %T An Ostomy Self-management Telehealth Intervention for Cancer Survivors: Technology-Related Findings From a Randomized Controlled Trial %A Weinstein,Ronald S %A Holcomb,Michael J %A Mo,Julia %A Yonsetto,Peter %A Bojorquez,Octavio %A Grant,Marcia %A Wendel,Christopher S %A Tallman,Nancy J %A Ercolano,Elizabeth %A Cidav,Zuleyha %A Hornbrook,Mark C %A Sun,Virginia %A McCorkle,Ruth %A Krouse,Robert S %+ Arizona Telemedicine Program, The University of Arizona Health Sciences, 1501 N Campbell AHSL 1156, Tucson, AZ, 85724, United States, 1 5203733552, rweinstein@telemedicine.arizona.edu %K telehealth %K telemedicine %K cloud computing %K ostomy %K cancer survivors %K family caregivers %K self-management %K patient education %K videoconferencing %K mobile phone %D 2021 %7 27.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: An Ostomy Self-management Telehealth (OSMT) intervention by nurse educators and peer ostomates can equip new ostomates with critical knowledge regarding ostomy care. A telehealth technology assessment aim was to measure telehealth engineer support requirements for telehealth technology–related (TTR) incidents encountered during OSMT intervention sessions held via a secure cloud-based videoconferencing service, Zoom for Healthcare. Objective: This paper examines technology-related challenges, issues, and opportunities encountered in the use of telehealth in a randomized controlled trial intervention for cancer survivors living with a permanent ostomy. Methods: The Arizona Telemedicine Program provided telehealth engineering support for 105 OSMT sessions, scheduled for 90 to 120 minutes each, over a 2-year period. The OSMT groups included up to 15 participants, comprising 4-6 ostomates, 4-6 peer ostomates, 2 nurse educators, and 1 telehealth engineer. OSMT-session TTR incidents were recorded contemporaneously in detailed notes by the research staff. TTR incidents were categorized and tallied. Results: A total of 97.1% (102/105) OSMT sessions were completed as scheduled. In total, 3 OSMT sessions were not held owing to non–technology-related reasons. Of the 93 ostomates who participated in OSMT sessions, 80 (86%) completed their OSMT curriculum. TTR incidents occurred in 36.3% (37/102) of the completed sessions with varying disruptive impacts. No sessions were canceled or rescheduled because of TTR incidents. Disruptions from TTR incidents were minimized by following the TTR incident prevention and incident response plans. Conclusions: Telehealth videoconferencing technology can enable ostomates to participate in ostomy self-management education by incorporating dedicated telehealth engineering support. Potentially, OSMT greatly expands the availability of ostomy self-management education for new ostomates. Trial Registration: ClinicalTrials.gov NCT02974634; https://clinicaltrials.gov/ct2/show/NCT02974634 %M 34086595 %R 10.2196/26545 %U https://www.jmir.org/2021/9/e26545 %U https://doi.org/10.2196/26545 %U http://www.ncbi.nlm.nih.gov/pubmed/34086595 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 9 %N 3 %P e26084 %T A Cognitive Behavioral Therapy–, Biofeedback-, and Game-Based eHealth Intervention to Treat Anxiety in Children and Young People With Long-Term Physical Conditions (Starship Rescue): Co-design and Open Trial %A Thabrew,Hiran %A Stasiak,Karolina %A Kumar,Harshali %A Naseem,Tarique %A Frampton,Christopher %A Merry,Sally %+ Department of Psychological Medicine, University of Auckland, Building 507, School of Medicine, Level 3, 22-30 Park Avenue, Grafton, Auckland, 1011, New Zealand, 64 21 402 055, h.thabrew@auckland.ac.nz %K long-term physical conditions %K chronic illness %K anxiety %K eHealth %K gaming %K young people %K treatment %K cognitive behavioral therapy %K biofeedback %D 2021 %7 24.9.2021 %9 Original Paper %J JMIR Serious Games %G English %X Background: Approximately 10%-12% of New Zealand children and young people have long-term physical conditions (chronic illnesses) and are more likely to develop psychological problems, particularly anxiety and depression. Delayed treatment leads to worse health care and poorer long-term outcomes. Recently, eHealth interventions, especially those based on principles of cognitive behavioral therapy and biofeedback, have been shown to be moderately effective in reducing anxiety. However, these modalities have rarely been combined. Young people have expressed a preference for well-designed and technology-based support to deal with psychological issues. Objective: This study aims to co-design and evaluate the acceptability and usability of a cognitive behavioral therapy and biofeedback-based, 5-module eHealth game called Starship Rescue and to provide preliminary evidence regarding its effectiveness in addressing anxiety and quality of life in young people with long-term physical conditions. Methods: Starship Rescue was co-designed with 15 children and young people from a tertiary hospital in New Zealand. Following this, 24 others aged 10-17 years participated in an open trial of the game, accessing it over an 8-week period. The acceptability of the game to all participants was assessed using a brief, open-ended questionnaire. More detailed feedback was obtained from a subset of 10 participants via semistructured interviews. Usability was evaluated via device-recorded frequency and duration of access on completion of the game and the System Usability Scale. Anxiety levels were measured at baseline, completion, and 3 months after completion of the game using the Generalized Anxiety Disorder 7-item scale and Spence Child Anxiety Scale, and at the start of each module and on completion using an embedded Likert visual analog scale. Quality of life was measured at baseline, completion, and 3 months after completion using the Pediatric Quality of Life Inventory scale. Results: Users gave Starship Rescue an overall rating of 5.9 out of 10 (range 3-10) and a mean score of 71 out of 100 (SD 11.7; minimum 47.5; maximum 90) on the System Usability Scale. The mean period for the use of the game was just over 11 weeks (78.8 days, 13.5 hours, 40 minutes). Significant reductions in anxiety were noted between the start and end of the game on the Generalized Anxiety Disorder 7-item scale (−4.6; P<.001), Spence Child Anxiety Scale (−9.6; P=.005), and the Likert visual analog scales (−2.4; P=.001). Quality of life also improved on the Pediatric Quality of Life Inventory scale (+4.3; P=.04). All changes were sustained at the 3-month follow-up. Conclusions: This study provides preliminary evidence for Starship Rescue as an acceptable, usable, and effective eHealth intervention for treating anxiety in young people with long-term physical conditions. Further evaluation is planned via a randomized controlled trial. Trial Registration: Australian New Zealand Clinical Trials Network Registry (ANZCTR) ACTRN12616001253493; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371443 %M 34559053 %R 10.2196/26084 %U https://games.jmir.org/2021/3/e26084 %U https://doi.org/10.2196/26084 %U http://www.ncbi.nlm.nih.gov/pubmed/34559053 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e19896 %T Factors Affecting Engagement in Web-Based Health Care Patient Information: Narrative Review of the Literature %A Oktay,Liam Alperen %A Abuelgasim,Eyad %A Abdelwahed,Aida %A Houbby,Nour %A Lampridou,Smaragda %A Normahani,Pasha %A Peters,Nicholas %A Jaffer,Usman %+ Imperial College NHS Trust, Praed Street, London, W2 0NE, United Kingdom, 44 7968872992, usman.jaffer@nhs.net %K patient education %K web-based health information %K internet %K patient engagement %K mobile phone %D 2021 %7 23.9.2021 %9 Review %J J Med Internet Res %G English %X Background: Web-based content is rapidly becoming the primary source of health care information. There is a pressing need for web-based health care content to not only be accurate but also be engaging. Improved engagement of people with web-based health care content has the potential to inform as well as influence behavioral change to enable people to make better health care choices. The factors associated with better engagement with web-based health care content have previously not been considered. Objective: The aims of this study are to identify the factors that affect engagement with web-based health care content and develop a framework to be considered when creating such content. Methods: A comprehensive search of the PubMed and MEDLINE database was performed from January 1, 1946, to January 5, 2020. The reference lists of all included studies were also searched. The Medical Subject Headings database was used to derive the following keywords: “patient information,” “online,” “internet,” “web,” and “content.” All studies in English pertaining to the factors affecting engagement in web-based health care patient information were included. No restrictions were set on the study type. Analysis of the themes arising from the results was performed using inductive content analysis. Results: The search yielded 814 articles, of which 56 (6.9%) met our inclusion criteria. The studies ranged from observational and noncontrolled studies to quasi-experimental studies. Overall, there was significant heterogeneity in the types of interventions and outcome assessments, which made quantitative assessment difficult. Consensus among all authors of this study resulted in six categories that formed the basis of a framework to assess the factors affecting engagement in web-based health care content: easy to understand, support, adaptability, accessibility, visuals and content, and credibility and completeness. Conclusions: There is a paucity of high-quality data relating to the factors that improve the quality of engagement with web-based health care content. Our framework summarizes the reported studies, which may be useful to health care content creators. An evaluation of the utility of web-based content to engage users is of significant importance and may be accessible through tools such as the Net Promoter score. Web 3.0 technology and development of the field of psychographics for health care offer further potential for development. Future work may also involve improvement of the framework through a co-design process. %M 34554104 %R 10.2196/19896 %U https://www.jmir.org/2021/9/e19896 %U https://doi.org/10.2196/19896 %U http://www.ncbi.nlm.nih.gov/pubmed/34554104 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 9 %P e29110 %T Low Carb Program Health App Within a Hospital-Based Obesity Setting: Observational Service Evaluation %A Hanson,Petra %A Summers,Charlotte %A Panesar,Arjun %A Oduro-Donkor,Dominic %A Lange,Maria %A Menon,Vinod %A Barber,Thomas M %+ DDM Health, Technology House, Science Park, University of Warwick, Coventry, CV4 7EZ, United Kingdom, 44 2476712201, charlotte@ddm.health %K obesity %K low carb program %K eHealth %K mobile app %K digital health %K health intervention %K mobile health %K COVID-19 %D 2021 %7 23.9.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Obesity underlies much chronic disease. Digitalization of obesity management provides an opportunity to innovate our traditional model of health care delivery within this setting, and to transform its scalability potentially to the population level. Objective: The objective was to assess the feasibility and effectiveness of the Low Carb Program app for weight loss, applied within our hospital-based (tier 3) obesity service. Due to the disrupting effects of the COVID-19 pandemic on our obesity service, we compared the clinical outcomes from the Low Carb Program app applied in the context of remote patient appointments over the telephone with the prepandemic traditional standard of care. Methods: We invited patients who attended our hospital-based obesity service to engage with the Low Carb Program smartphone app. We combined this approach with remote delivery (over the telephone) of obesity management from medical and psychology members of our obesity team during the COVID-19 pandemic. Outcome variables included changes in body weight and changes in HbA1c as a marker of glycemic control. We compared data from the Low Carb Program group with a retrospective control group (n=126) that had received traditional face-to-face obesity management from our team without concomitant use of the Low Carb Program app in the pre–COVID-19 era. T test comparisons were employed, with P<.05 considered significant. Results: The mean weight of participants (n=105) was 130.2 kg, with 59% (n=62) females and a mean age of 48.8 years. Most participants (90/105, 86%) completed the Low Carb Program app registration process and engaged with the Low Carb Program app program; at follow-up, most participants (88/105, 84%) had actively engaged with the Low Carb Program app within the prior 30 days. The majority of participants (58/105, 55%) self-reported outcomes within the app. Mean duration of clinical follow-up for recruited participants who received the app was 7.4 months. Paired data were available for 48 participants for body weight and 41 participants for HbA1c. Paired sample t test analysis revealed a statistically significant mean loss of body weight of 2.7 kg (P=.001) and improvement in HbA1c of 3.3 mmol/mol (P=.01). The mean weight of control group patients (n=126) was 137.1 kg, with 74% (93/126) females and a mean age of 44.4 years. The mean follow-up for this group was 6 months. Data comparisons between the app user group and the pre–COVID-19 retrospective control group revealed equivalence for loss of body weight and change in HbA1c between the two groups. Conclusions: We provide evidence to support the feasibility of implementing the Low Carb Program app combined with remote management; this is the first proof of concept for digitalized management within a hospital-based (tier 3) obesity service. We demonstrate the potential clinical efficacy of the approach in terms of improvements in body weight and glycemic control. %M 34449405 %R 10.2196/29110 %U https://formative.jmir.org/2021/9/e29110 %U https://doi.org/10.2196/29110 %U http://www.ncbi.nlm.nih.gov/pubmed/34449405 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e28976 %T Building Primary Health Care Personnel’s Support for a Patient Portal While Alleviating eHealth-Related Stress: Survey Study %A Hörhammer,Iiris %A Kujala,Sari %A Hilama,Pirjo %A Heponiemi,Tarja %+ Department of Industrial Engineering and Management, Aalto University, Otaniementie 1, Espoo, 02150, Finland, 358 503430063, iiris.riippa@aalto.fi %K patient portal %K implementation %K adoption %K health care personnel %K eHealth-related stress %D 2021 %7 22.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Health care personnel’s (HCP) engagement in patient portal implementation is necessary in embedding the use of the portal in everyday practices of a health care organization. While portal implementation may raise personnel’s positive expectations of the benefits in patient care, it is often also stressful for them due to increased workloads and disruptions in clinical workflows. An understanding of social and technical factors that build personnel’s support for patient portal implementation and alleviate their eHealth-related stress is therefore needed to realize the full potential of portals. Objective: The aim of this study was to explore the influence of managerial implementation practices, information technology (IT) usability, and personnel’s eHealth competences on support for patient portal implementation and eHealth-related stress among primary HCP. Methods: The data were collected through a survey of 919 members at 2 health organizations in Finland. Linear and logistic regression models were fitted to study the associations between the variables. Results: Professionals’ eHealth competence (β=.15, P<.001), usability (β=.11, P<.001), and implementation practices (β=.07, P<.001) were positively associated with professionals’ support and negatively associated with professionals eHealth-related stress (β=−.07, P=.010; β=−.27, P<.001; and β=−.14, P<.001, respectively). Professionals’ support was associated with their promotion of the portal to the patients (odds ratio 1.22, 95% CI 1.07-1.40). Conclusions: The adoption of appropriate implementation practices and the usability of the technology can build personnel’s support for a patient portal and alleviate their stress related to eHealth. Personnel’s support is manifested in their promotion of the portal to patients. Health care managers are encouraged to consider the usability of the technology and the good implementation practices, such as proper informing, engagement of the personnel in planning the services, and allocation of resources to improve eHealth competence, as prerequisites for meaningful and sustainable use of patient portals. %M 34550087 %R 10.2196/28976 %U https://www.jmir.org/2021/9/e28976 %U https://doi.org/10.2196/28976 %U http://www.ncbi.nlm.nih.gov/pubmed/34550087 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e25922 %T Facilitator Contact, Discussion Boards, and Virtual Badges as Adherence Enhancements to a Web-Based, Self-guided, Positive Psychological Intervention for Depression: Randomized Controlled Trial %A Moskowitz,Judith Tedlie %A Addington,Elizabeth L %A Shiu,Eva %A Bassett,Sarah M %A Schuette,Stephanie %A Kwok,Ian %A Freedman,Melanie E %A Leykin,Yan %A Saslow,Laura R %A Cohn,Michael A %A Cheung,Elaine O %+ Department of Medical Social Sciences, Osher Center for Integrative Medicine, Northwestern University Feinberg School of Medicine, 625 N Michigan Ave, Suite 2700, Chicago, IL, 60611, United States, 1 3125037712, judith.moskowitz@northwestern.edu %K mHealth %K adherence %K depression %K discussion board %K gamification %K positive psychological intervention %K mobile phone %D 2021 %7 22.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Adherence to self-guided interventions tends to be very low, especially in people with depression. Prior studies have demonstrated that enhancements may increase adherence, but little is known about the efficacy of various enhancements in comparison to, or in combination with, one another. Objective: The aim of our study is to test whether 3 enhancements—facilitator contact (FC), an online discussion board, and virtual badges (VB)—alone, or in combination, improve adherence to a self-guided, web-based intervention for depression. We also examined whether age, gender, race, ethnicity, comfort with technology, or baseline depression predicted adherence or moderated the effects that each enhancement had on adherence. Methods: Participants were recruited through web-based sources and, after completing at least 4 out of 7 daily emotion reports, were sequentially assigned to 1 of 9 conditions—the intervention alone; the intervention plus 1, 2, or all 3 enhancements; or an emotion reporting control condition. The intervention was a positive psychological program consisting of 8 skills that specifically targeted positive emotions, and it was delivered over 5 weeks in a self-guided, web-based format. We operationalized adherence as the number of skills accessed. Results: A total of 602 participants were enrolled in this study. Participants accessed, on average, 5.61 (SD 2.76) of 8 skills. The total number of enhancements participants received (0-3) did not predict the number of skills accessed. Participants who were assigned to the VB+FC condition accessed significantly more skills than those in the intervention only conditions. Furthermore, participants in arms that received the combination of both the VB and FC enhancements (VB+FC and VB+FC+online discussion board) accessed a greater number of skills relative to the number of skills accessed by participants who received either VB or FC without the other. Moderation analyses revealed that the receipt of VB (vs no VB) predicted higher adherence among participants with moderately severe depression at baseline. Conclusions: The results suggested that the VB+FC combination significantly increased the number of skills accessed in a self-guided, web-based intervention for elevated depression. We have provided suggestions for refinements to these enhancements, which may further improve adherence. Trial Registration: ClinicalTrials.gov NCT02861755; http://clinicaltrials.gov/ct2/show/NCT02861755 %M 34550076 %R 10.2196/25922 %U https://www.jmir.org/2021/9/e25922 %U https://doi.org/10.2196/25922 %U http://www.ncbi.nlm.nih.gov/pubmed/34550076 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e30107 %T A Web-Based Integrated Management Program for Improving Medication Adherence and Quality of Life, and Reducing Readmission in Patients With Atrial Fibrillation: Randomized Controlled Trial %A Hsieh,Hui-Ling %A Kao,Chi-Wen %A Cheng,Shu-Meng %A Chang,Yue-Cune %+ School of Nursing, National Defense Medical Center, No 161, Sec 6, Minchuan E Rd, Neihu District, Taipei, 11490, Taiwan, 886 2 8792 3100, chiwenkao@ndmctsgh.edu.tw %K web-based program %K atrial fibrillation %K coping strategy %K medication adherence %K readmission %K health-related quality of life %D 2021 %7 22.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Atrial fibrillation (AF) is related to a variety of chronic diseases and life-threatening complications. It is estimated that by 2050, there will be 72 million patients with AF in Asia, of which 2.9 million will have AF-associated stroke. AF has become a major issue for health care systems. Objective: We aimed to evaluate the effects of a web-based integrated management program on improving coping strategies, medication adherence, and health-related quality of life (HRQoL) in patients with AF, and to detect the effect on decreasing readmission events. Methods: The parallel-group, single-blind, prospective randomized controlled trial recruited patients with AF from a medical center in northern Taiwan and divided them randomly into intervention and control groups. Patients in the intervention group received the web-based integrated management program, whereas those in the control group received usual care. The measurement tools included the Brief Coping Orientation to Problems Experienced (COPE) scale, Medication Adherence Rating Scale (MARS), the three-level version of the EuroQoL five-dimension self-report questionnaire (EQ-5D-3L), and readmission events 2 years after initiating the intervention. Data were collected at 4 instances (baseline, 1 month, 3 months, and 6 months after initiating the intervention), and analyzed with generalized estimating equations (GEEs). Results: A total of 231 patients were recruited and allocated into an intervention (n=115) or control (n=116) group. The mean age of participants was 73.08 (SD 11.71) years. Most participants were diagnosed with paroxysmal AF (171/231, 74%), and the most frequent comorbidity was hypertension (162/231, 70.1%). Compared with the control group, the intervention group showed significantly greater improvement in approach coping strategies, medication adherence, and HRQoL at 1, 3, and 6 months (all P<.05). In addition, the intervention group showed significantly fewer readmission events within 2 years (OR 0.406, P=.03), compared with the control group. Conclusions: The web-based integrated management program can significantly improve patients' coping strategy and medication adherence. Therefore, it can empower patients to maintain disease stability, which is a major factor in improving their HRQoL and reducing readmission events within 2 years. Trial Registration: ClinicalTrials.gov NCT04813094; https://clinicaltrials.gov/ct2/show/NCT04813094. %M 34550084 %R 10.2196/30107 %U https://www.jmir.org/2021/9/e30107 %U https://doi.org/10.2196/30107 %U http://www.ncbi.nlm.nih.gov/pubmed/34550084 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 9 %P e30990 %T Feasibility and Acceptability of a Web-Based Caregiver Decision Aid (Safety in Dementia) for Firearm Access: Pilot Randomized Controlled Trial %A Betz,Marian E %A Polzer,Evan %A Nearing,Kathryn %A Knoepke,Christopher E %A Johnson,Rachel L %A Meador,Lauren %A Matlock,Daniel D %+ Department of Emergency Medicine, University of Colorado Anschutz Medical Campus, 12401 E 17th Avenue, B-215, Aurora, CO, 80045, United States, 1 7208486777, marian.betz@ucdenver.edu %K dementia %K cognitive impairment %K firearm %K decision aid %K caregivers %K safety %K feasibility %K pilot trial %K Alzheimer disease %K caregiver support %D 2021 %7 22.9.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Firearms are common in the households of persons with Alzheimer disease and related dementias (ADRD). Safety in Dementia (SiD) is a free web-based decision aid that was developed to support ADRD caregivers in addressing firearm access. Objective: We aimed to evaluate the feasibility and acceptability of SiD among a web-based sample of ADRD caregivers. Methods: SiD was tested in 2 phases by using participants who were recruited from a web-based convenience sample (Amazon Mechanical Turk participants). In phase 1, caregivers were randomized to view either the intervention (SiD) or the control (Alzheimer’s Association materials), and the blinding of participants to the study arms was conducted. In phase 2, caregivers of individuals with ADRD and firearm access were recruited; all of these participants viewed the firearm section of SiD. In both phases, participants viewed SiD independently for as long as they wanted. Measures for evaluating decision-making and SiD acceptability were used, and these were assessed via a self-administered web-based questionnaire. Results: Participants were recruited for phases 1 (n=203) and 2 (n=54). Although it was feasible to collect the study outcome data in a web-based format, in phase 1, there were no significant differences between SiD and the control in terms of decision-making and self-efficacy. The majority (137/203, 67.5%) of phase 1 participants spent between 5 and 10 minutes reviewing the resources. In phase 2, 61% (33/54) of participants spent 5 to 10 minutes viewing the firearm section, and 31% (17/54) spent 10 to 20 minutes viewing this section. Usability and acceptability were high across the phases. Conclusions: SiD represents a new resource for promoting safety among people with dementia, and high acceptability was achieved in a pilot trial. In this sample, SiD performed similarly to Alzheimer’s Association materials in supporting decision-making and self-efficacy. %M 34550082 %R 10.2196/30990 %U https://formative.jmir.org/2021/9/e30990 %U https://doi.org/10.2196/30990 %U http://www.ncbi.nlm.nih.gov/pubmed/34550082 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 9 %P e17913 %T Development, Implementation, and Effectiveness of a Self-sustaining, Web-Based LGBTQ+ National Platform: A Framework for Centralizing Local Health Care Resources and Culturally Competent Providers %A Nowaskie,Dustin Z %+ Department of Psychiatry, Indiana University School of Medicine, 355 W 16th Street, #2364, Indianapolis, IN, 46202, United States, 1 317 963 7307, dznowaskie@gmail.com %K cultural competency %K disparities %K e-health %K healthcare %K internet %K LGBTQ+ %K online platform %K providers %K resources %K eHealth %K health care %D 2021 %7 22.9.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: The lesbian, gay, bisexual, transgender, queer, and other sexual and gender minority (LGBTQ+) population has long faced substantial marginalization, discrimination, and health care disparities compared to the cisgender, heterosexual population. As the etiology of such disparities is multifaceted, finding concrete solutions for LGBTQ+ health care equity is challenging. However, the internet may offer the space to initiate an effective model. Objective: In an effort to make LGBTQ+ public resources and culturally competent providers transparent, modernize medical education, and promote cultural competency, OutCare Health—a nonprofit 501(c)(3) multidisciplinary, multicenter web-based platform—was created. Methods: The organization employs a cyclic, multidimensional framework to conduct needs assessments, identify resources and providers, promote these efforts on the website, and educate the next generation of providers. LGBTQ+ public health services are identified via the internet, email, and word of mouth and added to the Public Resource Database; culturally competent providers are recruited to the OutList directory via listservs, medical institutions, local organizations, and word of mouth; and mentors are invited to the Mentorship Program by emailing OutList providers. These efforts are replicated across nearly 30 states in the United States. Results: The organization has identified over 500 public health organizations across all states, recognized more than 2000 OutList providers across all states and 50 specialties, distributed hundreds of thousands of educational materials, received over 10,000 monthly website visits (with 83% unique viewership), and formed nearly 30 state-specific teams. The total number of OutList providers and monthly website views has doubled every 12-18 months. The majority of OutList providers are trained in primary, first point-of-care specialties such as family medicine, infectious disease, internal medicine, mental health, obstetrics and gynecology, and pediatrics. Conclusions: A web-based LGBTQ+ platform is a feasible, effective model to identify public health resources, culturally competent providers, and mentors as well as provide cultural competency educational materials and education across the country. Such a platform also has the opportunity to reach self-perpetuating sustainability. The cyclic, multidisciplinary, multidimensional, multicenter framework presented here appears to be pivotal in achieving such growth and stability. Other organizations and medical institutions should heavily consider using this framework to reach their own communities with high-quality, culturally competent care for the LGBTQ+ population. %M 34550083 %R 10.2196/17913 %U https://formative.jmir.org/2021/9/e17913 %U https://doi.org/10.2196/17913 %U http://www.ncbi.nlm.nih.gov/pubmed/34550083 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 9 %P e27570 %T Evaluation of a Commercial Mobile Health App for Depression and Anxiety (AbleTo Digital+): Retrospective Cohort Study %A Anton,Margaret T %A Greenberger,Heidi Mochari %A Andreopoulos,Evie %A Pande,Reena L %+ AbleTo, Inc, 320 W, 37th Street, 5th floor, New York, NY, 10018, United States, 1 (347) 926 5527, margaret.anton@ableto.com %K digital mental health %K mHealth %K iCBT %K coaching %K depression %K generalized anxiety %K social anxiety %K mobile phone %D 2021 %7 21.9.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital solutions, such as web-based and mobile interventions, have the potential to streamline pathways to mental health services and improve access to mental health care. Although a growing number of randomized trials have established the efficacy of digital interventions for common mental health problems, less is known about the real-world impact of these tools. AbleTo Digital+, a commercially available mental health app for depression and anxiety, offers a unique opportunity to understand the clinical impact of such tools delivered in a real-world context. Objective: The primary aim of this study is to examine the magnitude of change in depression and anxiety symptoms among individuals who used AbleTo Digital+ programs. The secondary aim is to evaluate Digital+ module completion, including the use of 1:1 coaching. Methods: In this retrospective cohort study, we analyzed previously collected and permanently deidentified data from a consecutive cohort of 1896 adults who initiated using one of the three Digital+ eight-module programs (depression, generalized anxiety, or social anxiety) between January 1 and June 30, 2020. Depression, generalized anxiety, and social anxiety symptoms were assessed within each program using the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7, and the Social Phobia Inventory, respectively. Linear mixed effects models were built to assess the association between module completion and symptom change among users who completed at least four modules and had at least mild baseline symptom elevations, controlling for age, gender, and baseline symptom severity. Digital+ use, including module completion, 1:1 coaching calls, and in-app coach messaging, was also evaluated. Results: Significant effects were observed among depression (Cohen d=1.5), generalized anxiety (Cohen d=1.2), and social anxiety (Cohen d=1.0) program participants who completed at least four modules and had mild baseline elevations (n=470). Associations between module completion and change in depression (β=−1.2; P<.001), generalized anxiety (β=−1.1; P<.001), and social anxiety (β=−2.4; P<.001) symptom scores retained significance with covariate adjustment. Participants completed an average of 2.6 (SD 2.7) modules. The average total length of app use was 52.2 (SD 83.5) days. Approximately two-thirds of the users engaged in at least 1 coaching call (66.82%, 1267/1896) or in-app text messaging (66.09%, 1253/1896). Participants who completed at least four modules participated in significantly more coaching calls per module (mean 1.1, SD 0.7) than users who completed fewer than four modules (mean 1.0, SD 1.2; t1407=−2.1; P=.03). Conclusions: This study demonstrated that AbleTo Digital+ users experienced significant reductions in depression, generalized anxiety, and social anxiety symptoms throughout the program. %M 34546170 %R 10.2196/27570 %U https://formative.jmir.org/2021/9/e27570 %U https://doi.org/10.2196/27570 %U http://www.ncbi.nlm.nih.gov/pubmed/34546170 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e25171 %T How Self-tracking and the Quantified Self Promote Health and Well-being: Systematic Review %A Feng,Shan %A Mäntymäki,Matti %A Dhir,Amandeep %A Salmela,Hannu %+ Department of Management and Entrepreneurship, Turku School of Economics, University of Turku, Rehtorinpellonkatu 3, Turku, 20500, Finland, 358 504867657, matti.mantymaki@utu.fi %K self-tracking %K quantified self %K health %K well-being %K systematic literature review %K literature review %D 2021 %7 21.9.2021 %9 Review %J J Med Internet Res %G English %X Background: Self-tracking technologies are widely used in people’s daily lives and health care. Academic research on self-tracking and the quantified self has also accumulated rapidly in recent years. Surprisingly, there is a paucity of research that reviews, classifies, and synthesizes the state of the art with respect to self-tracking and the quantified self. Objective: Our objective was to identify the state of the art of self-tracking and the quantified self in terms of health and well-being. Methods: We have undertaken a systematic literature review on self-tracking and the quantified self in promoting health and well-being. After a rigorous literature search, followed by inclusions, exclusions, and the application of article quality assessment protocols, 67 empirical studies qualified for the review. Results: Our results demonstrate that prior research has focused on 3 stakeholders with respect to self-tracking and the quantified self, namely end users, patients and people with illnesses, and health care professionals and caregivers. We used these stakeholder groups to cluster the research themes of the reviewed studies. We identified 11 research themes. There are 6 themes under the end-user cluster: user motivation and goal setting, usage and effects of self-tracking, continuance intention and long-term usage, management of personal data, rejection and discontinuance, and user characteristics. The patient and people with illnesses cluster contains three themes: usage experience of patients and people with illnesses, management of patient-generated data, and advantages and disadvantages in the clinical context. The health care professional and caregiver cluster contains two themes: collaboration among patients, health care professionals, and caregivers, and changes in the roles of patients and professionals. Moreover, we classified the future research suggestions given in the literature into 5 directions in terms of research designs and research topics. Finally, based on our reflections on the observations from the review, we suggest four future research directions: (1) users’ cognitions and emotions related to processing and interpreting the information produced by tracking devices and apps; (2) the dark side of self-tracking (eg, its adverse psychosocial consequences); (3) self-tracking as a societal phenomenon; and (4) systemic impacts of self-tracking on health care and the actors involved. Conclusions: This systematic literature review contributes to research and practice by assisting future research activities and providing practitioners with a concise overview of the state of the art of self-tracking and the quantified self. %M 34546176 %R 10.2196/25171 %U https://www.jmir.org/2021/9/e25171 %U https://doi.org/10.2196/25171 %U http://www.ncbi.nlm.nih.gov/pubmed/34546176 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 9 %P e29454 %T School-Based Suicide Risk Assessment Using eHealth for Youth: Systematic Scoping Review %A Exner-Cortens,Deinera %A Baker,Elizabeth %A Gray,Shawna %A Fernandez Conde,Cristina %A Rivera,Rocio Ramirez %A Van Bavel,Marisa %A Vezina,Elisabeth %A Ambrose,Aleta %A Pawluk,Chris %A Schwartz,Kelly D %A Arnold,Paul D %+ Department of Psychology, University of Calgary, 2500 University Drive NW, Calgary, AB, T2N1N4, Canada, 1 4032208871, deinera.exner2@ucalgary.ca %K suicide %K risk assessment %K youth %K eHealth %K school mental health %K mobile phone %D 2021 %7 21.9.2021 %9 Review %J JMIR Ment Health %G English %X Background: Suicide is a leading cause of death among youth and a prominent concern for school mental health providers. Indeed, schools play a key role in suicide prevention, including participating in risk assessments with students expressing suicidal ideation. In the context of the COVID-19 pandemic, many schools now need to offer mental health services, including suicide risk assessment, via eHealth platforms. Post pandemic, the use of eHealth risk assessments will support more accessible services for youth living in rural and remote areas. However, as the remote environment is a new context for many schools, guidance is needed on best practices for eHealth suicide risk assessment among youth. Objective: This study aims to conduct a rapid, systematic scoping review to explore promising practices for conducting school-based suicide risk assessment among youth via eHealth (ie, information technologies that allow for remote communication). Methods: This review included peer-reviewed articles and gray literature published in English between 2000 and 2020. Although we did not find studies that specifically explored promising practices for school-based suicide risk assessment among youth via eHealth platforms, we found 12 peer-reviewed articles and 23 gray literature documents that contained relevant information addressing our broader study purpose; thus, these 35 sources were included in this review. Results: We identified five key recommendation themes for school-based suicide risk assessment among youth via eHealth platforms in the 12 peer-reviewed studies. These included accessibility, consent procedures, session logistics, safety planning, and internet privacy. Specific recommendation themes from the 23 gray literature documents substantially overlapped with and enhanced three of the themes identified in the peer-reviewed literature—consent procedures, session logistics, and safety planning. In addition, based on findings from the gray literature, we expanded the accessibility theme to a broader theme termed youth engagement, which included information on accessibility and building rapport, establishing a therapeutic space, and helping youth prepare for remote sessions. Finally, a new theme was identified in the gray literature findings, specifically concerning school mental health professional boundaries. A second key difference between the gray and peer-reviewed literature was the former’s focus on issues of equity and access and how technology can reinforce existing inequalities. Conclusions: For school mental health providers in need of guidance, we believe that these six recommendation themes (ie, youth engagement, school mental health professional boundaries, consent procedures, session logistics, safety planning, and internet privacy) represent the most promising directions for school-based suicide risk assessment among youth using eHealth tools. However, suicide risk assessment among youth via eHealth platforms in school settings represents a critical research gap. On the basis of the findings of this review, we provide specific recommendations for future research, including the need to focus on the needs of diverse youth. %M 34546178 %R 10.2196/29454 %U https://mental.jmir.org/2021/9/e29454 %U https://doi.org/10.2196/29454 %U http://www.ncbi.nlm.nih.gov/pubmed/34546178 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 9 %P e31976 %T The Finding My Way UK Clinical Trial: Adaptation Report and Protocol for a Replication Randomized Controlled Efficacy Trial of a Web-Based Psychological Program to Support Cancer Survivors %A Hulbert-Williams,Nicholas J %A Leslie,Monica %A Hulbert-Williams,Lee %A Koczwara,Bogda %A Watson,Eila K %A Hall,Peter S %A Ashley,Laura %A Coulson,Neil S %A Jackson,Richard %A Millington,Sue %A , %A Beatty,Lisa %+ Centre for Contextual Behavioural Science, School of Psychology, University of Chester, Parkgate Road, Chester, CH1 4BJ, United Kingdom, 44 1244511950, n.hulbertwilliams@chester.ac.uk %K cancer %K survivorship %K psychosocial intervention %K digital health %K quality of life %K protocol %K mobile phone %D 2021 %7 20.9.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cancer survivors frequently report a range of unmet psychological and supportive care needs; these often continue after treatment has finished and are predictive of psychological distress and poor health-related quality of life. Web-based interventions demonstrate good efficacy in addressing these concerns and are more accessible than face-to-face interventions. Finding My Way (FMW) is a web-based, psycho-educational, and cognitive behavioral therapy intervention for cancer survivors developed in Australia. Previous trials have demonstrated that FMW is acceptable, highly adhered to, and effective in reducing the impact of distress on quality of life while leading to cost savings through health resource use reduction. Objective: This study aims to adapt the Australian FMW website for a UK cancer care context and then undertake a single-blinded, randomized controlled trial of FMW UK against a treatment-as-usual waitlist control. Methods: To an extent, our trial design replicates the existing Australian randomized controlled trial of FMW. Following a comprehensive adaptation of the web resource, we will recruit 294 participants (147 per study arm) from across clinical sites in North West England and North Wales. Participants will have been diagnosed with cancer of any type in the last 6 months, have received anticancer treatment with curative intent, be aged ≥16 years, be proficient in English, and have access to the internet and an active email address. Participants will be identified and recruited through the National Institute for Health Research clinical research network. Measures of distress, quality of life, and health economic outcomes will be collected using a self-report web-based questionnaire at baseline, midtreatment, posttreatment, and both 3- and 6-month follow-up. Quantitative data will be analyzed using intention-to-treat mixed model repeated measures analysis. Embedded semistructured qualitative interviews will probe engagement with, and experiences of using, FMW UK and suggestions for future improvements. Results: The website adaptation work was completed in January 2021. A panel of cancer survivors and health care professionals provided feedback on the test version of FMW UK. Feedback was positive overall, although minor updates were made to website navigation, inclusivity, terminology, and the wording of the Improving Communication and Sexuality and Intimacy content. Recruitment for the clinical trial commenced in April 2021. We aim to report on findings from mid-2023. Conclusions: Replication studies are an important aspect of the scientific process, particularly in psychological and clinical trial literature, especially in different geographical settings. Before replicating the FMW trial in the UK setting, content updating was required. If FMW UK now replicates Australian findings, we will have identified a novel and cost-effective method of psychosocial care delivery for cancer survivors in the United Kingdom. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 14317248; https://www.isrctn.com/ISRCTN14317248 International Registered Report Identifier (IRRID): DERR1-10.2196/31976 %M 34542420 %R 10.2196/31976 %U https://www.researchprotocols.org/2021/9/e31976 %U https://doi.org/10.2196/31976 %U http://www.ncbi.nlm.nih.gov/pubmed/34542420 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e24307 %T Virtual Reality Technology Use in Cigarette Craving and Smoking Interventions (I “Virtually” Quit): Systematic Review %A Keijsers,Merel %A Vega-Corredor,Maria Cecilia %A Tomintz,Melanie %A Hoermann,Simon %+ School of Product Design, College of Engineering, University of Canterbury, 9 Engineering Road, Christchurch, 8041, New Zealand, 64 3 369 2457, simon.hoermann@canterbury.ac.nz %K virtual reality technology %K nicotine dependency %K nicotine addiction %K smoking addiction %K smoking intervention %K smoking therapy %K Electronic Nicotine Delivery Systems %D 2021 %7 17.9.2021 %9 Review %J J Med Internet Res %G English %X Background: Over the last 2 decades, virtual reality technologies (VRTs) have been proposed as a way to enhance and improve smoking cessation therapy. Objective: This systematic review aims to evaluate and summarize the current knowledge on the application of VRT in various smoking cessation therapies, as well as to explore potential directions for future research and intervention development. Methods: A literature review of smoking interventions using VRT was conducted. Results: Not all intervention studies included an alternative therapy or a placebo condition against which the effectiveness of the intervention could be benchmarked, or a follow-up measure to ensure that the effects were lasting. Virtual reality (VR) cue exposure therapy was the most extensively studied intervention, but its effect on long-term smoking behavior was inconsistent. Behavioral therapies such as a VR approach-avoidance task or gamified interventions were less common but reported positive results. Notably, only 1 study combined Electronic Nicotine Delivery Devices with VRT. Conclusions: The inclusion of a behavioral component, as is done in the VR approach-avoidance task and gamified interventions, may be an interesting avenue for future research on smoking interventions. As Electronic Nicotine Delivery Devices are still the subject of much controversy, their potential to support smoking cessation remains unclear. For future research, behavioral or multicomponent interventions are promising avenues of exploration. Future studies should improve their validity by comparing their intervention group with at least 1 alternative or placebo control group, as well as incorporating follow-up measures. %M 34533471 %R 10.2196/24307 %U https://www.jmir.org/2021/9/e24307 %U https://doi.org/10.2196/24307 %U http://www.ncbi.nlm.nih.gov/pubmed/34533471 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e19232 %T Remote Consultations Versus Standard Face-to-Face Appointments for Liver Transplant Patients in Routine Hospital Care: Feasibility Randomized Controlled Trial of myVideoClinic %A Damery,Sarah %A Jones,Janet %A O'Connell Francischetto,Elaine %A Jolly,Kate %A Lilford,Richard %A Ferguson,James %+ Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, United Kingdom, 44 1214147661, j.e.jones@bham.ac.uk %K digital health %K remote consultation %K patient satisfaction %K feasibility %K VSQ-9 %K secondary care %K liver transplant patients %K mobile phone %D 2021 %7 17.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Using technology to reduce the pressure on the National Health Service (NHS) in England and Wales is a key government target, and the NHS Long-Term Plan outlines a strategy for digitally enabled outpatient care to become mainstream by 2024. In 2020, the COVID-19 response saw the widespread introduction of remote consultations for patient follow-up, regardless of individual preferences. Despite this rapid change, there may be enduring barriers to the effective implementation of remote appointments into routine practice once the unique drivers for change during the COVID-19 pandemic no longer apply, to which pre-COVID implementation studies can offer important insights. Objective: This study aims to evaluate the feasibility of using real-time remote consultations between patients and secondary care physicians for routine patient follow-up at a large hospital in the United Kingdom and to assess whether patient satisfaction differs between intervention and usual care patients. Methods: Clinically stable liver transplant patients were randomized to real-time remote consultations in which their hospital physician used secure videoconferencing software (intervention) or standard face-to-face appointments (usual care). Participants were asked to complete postappointment questionnaires over 12 months. Data were analyzed on an intention-to-treat basis. The primary outcome was the difference in scores between baseline and study end by patient group for the three domains of patient satisfaction (assessed using the Visit-Specific Satisfaction Instrument). An embedded qualitative process evaluation used interviews to assess patient and staff experiences. Results: Of the 54 patients who were randomized, 29 (54%) received remote consultations, and 25 (46%) received usual care (recruitment rate: 54/203, 26.6%). The crossover between study arms was high (13/29, 45%). A total of 129 appointments were completed, with 63.6% (82/129) of the questionnaires being returned. Patient satisfaction at 12 months increased in both the intervention (25 points) and usual care (14 points) groups. The within-group analysis showed that the increases were significant for both intervention (P<.001) and usual care (P=.02) patients; however, the between-group difference was not significant after controlling for baseline scores (P=.10). The qualitative process evaluation showed that—according to patients—remote consultations saved time and money, were less burdensome, and caused fewer negative impacts on health. Technical problems with the software were common, and only 17% (5/29) of patients received all appointments over video. Both consultants and patients saw remote consultations as positive and beneficial. Conclusions: Using technology to conduct routine follow-up appointments remotely may ease some of the resource and infrastructure challenges faced by the UK NHS and free up clinic space for patients who must be seen face-to-face. Our findings regarding the advantages and challenges of using remote consultations for routine follow-ups of liver transplant patients have important implications for service organization and delivery in the postpandemic NHS. Trial Registration: ISRCTN Registry 14093266; https://www.isrctn.com/ISRCTN14093266 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-018-2953-4 %M 34533461 %R 10.2196/19232 %U https://www.jmir.org/2021/9/e19232 %U https://doi.org/10.2196/19232 %U http://www.ncbi.nlm.nih.gov/pubmed/34533461 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e22312 %T Web-Based Behavioral Intervention Utilizing Narrative Persuasion for HIV Prevention Among Chinese Men Who Have Sex With Men (HeHe Talks Project): Intervention Development %A Xin,Meiqi %A Coulson,Neil S %A Jiang,Crystal Li %A Sillence,Elizabeth %A Chidgey,Andrew %A Kwan,Norman Nok Man %A Mak,Winnie W S %A Goggins,William %A Lau,Joseph Tak Fai %A Mo,Phoenix Kit Han %+ Centre for Health Behaviours Research, Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, 202D, School of Public Health, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, New Territories, Hong Kong, Hong Kong, 852 22528765, phoenix.mo@cuhk.edu.hk %K narrative persuasion %K firsthand experiential stories %K online intervention %K HIV prevention %K sexual behavior %K men who have sex with men %D 2021 %7 16.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: In the era of potent antiretroviral therapy, a high level of condomless anal intercourse continues to drive increases in HIV incidence in recent years among men who have sex with men. Effective behavior change strategies for promoting HIV-preventive behaviors are warranted. Narrative persuasion is a novel health communication approach that has demonstrated its persuasive advantages in overcoming resistance to counterattitudinal messages. The efficacy of narrative persuasion in promoting health behavior changes has been well documented, but critical research gaps exist for its application to HIV prevention. Objective: In this study, we aimed to (1) capitalize on narrative persuasion to design a web-based multisession intervention for reducing condomless anal intercourse among men who have sex with men in Hong Kong (the HeHe Talks Project) by following a systematic development process; and (2) describe the main components of the narrative intervention that potentially determine its persuasiveness. Methods: Persuasive themes and subtopics related to reducing condomless anal intercourse were initially proposed based on epidemiological evidence. The biographic narrative interview method was used to elicit firsthand experiential stories from a maximum variation sample of local men who have sex with men with diverse backgrounds and experiences related to HIV prevention; different types of role models were established accordingly. Framework analysis was used to aggregate the original quotations from narrators into collective narratives under 6 intervention themes. A dedicated website was finally developed for intervention delivery. Results: A series of video-based intervention messages in biographic narrative format (firsthand experiential stories shared by men who have sex with men) combined with topic-equivalent argumentative messages were produced and programmed into 6 intervention sessions. The 6-week intervention program can be automatically delivered and monitored online. Conclusions: We systematically created a web-based HIV prevention intervention derived from peer-generated stories. Strategies used to enhance the efficacy of the narrative intervention have been discussed within basic communication components. This paper describes the methods and experiences of the rigorous development of a narrative communication intervention for HIV prevention, which enables replication of the intervention in the future. %M 34528889 %R 10.2196/22312 %U https://www.jmir.org/2021/9/e22312 %U https://doi.org/10.2196/22312 %U http://www.ncbi.nlm.nih.gov/pubmed/34528889 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 9 %P e28044 %T Testing the Differential Impact of an Internet-Based Mental Health Intervention on Outcomes of Well-being and Psychological Distress During COVID-19: Uncontrolled Intervention Study %A van Agteren,Joep %A Ali,Kathina %A Fassnacht,Daniel B %A Iasiello,Matthew %A Furber,Gareth %A Howard,Alexis %A Woodyatt,Lydia %A Musker,Michael %A Kyrios,Mike %+ Wellbeing and Resilience Centre, South Australian Health and Medical Research Institute, North Terrace, Adelaide, 5000, Australia, 61 881284944, joep.vanagteren@sahmri.com %K COVID-19 %K internet-based interventions %K mental health %K well-being %K intervention %K study %K impact %K internet %K online intervention %K distress %K resilience %K depression %K anxiety %K stress %D 2021 %7 15.9.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: During COVID-19, the psychological distress and well-being of the general population has been precarious, increasing the need to determine the impact of complementary internet-based psychological interventions on both positive mental health as well as distress states. Psychological distress and mental well-being represent distinct dimensions of our mental health, and congruent changes in outcomes of distress and well-being do not necessarily co-occur within individuals. When testing intervention impact, it is therefore important to assess change in both outcomes at the individual level, rather than solely testing group differences in average scores at the group level. Objective: This study set out to investigate the differential impact of an internet-based group mental health intervention on outcomes of positive mental health (ie, well-being, life satisfaction, resilience) and indicators of psychological distress (ie, depression, anxiety, stress). Methods: A 5-week mental health intervention was delivered to 89 participants using the Zoom platform during 2020. Impact on outcomes of distress, well-being, and resilience was assessed at the start and end of the program with multiple analysis of variance (MANOVA) and reliable change indices (RCIs) being used to determine program impact at the group and individual levels, respectively. Results: The intervention significantly improved all mental health outcomes measured, (F6,83=5.60, P<.001; Wilks Λ=.71; partial η2=.29) showing small to moderate effect sizes on individual outcomes. The largest effect sizes were observed for life satisfaction and overall well-being (η2=.22 and η2=.2, respectively). Larger effect sizes were noted for those with problematic mental health scores at baseline. A total of 92% (82/89) of participants demonstrated reliable change in at least one mental health outcome. Differential response patterns using RCI revealed that more than one-half of the participants showed improvement in both mental well-being and psychological distress, over one-quarter in outcomes of well-being only, and almost one-fifth in distress only. Conclusions: The results provide evidence for the significant impact of an internet-based mental health intervention during COVID-19 and indicate the importance of assessing dimensions of both well-being and distress when determining mental health intervention effectiveness. %M 34357876 %R 10.2196/28044 %U https://mental.jmir.org/2021/9/e28044 %U https://doi.org/10.2196/28044 %U http://www.ncbi.nlm.nih.gov/pubmed/34357876 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 9 %P e26029 %T A Cyberbullying Media-Based Prevention Intervention for Adolescents on Instagram: Pilot Randomized Controlled Trial %A Kutok,Emily R %A Dunsiger,Shira %A Patena,John V %A Nugent,Nicole R %A Riese,Alison %A Rosen,Rochelle K %A Ranney,Megan L %+ Brown-Lifespan Center for Digital Health, 139 Point Street, Providence, RI, 02903, United States, 1 (401) 444 2557, megan_ranney@brown.edu %K cyberbullying %K adolescents %K mobile application %K messaging %K brief interventions %K social media %K recruitment %K mobile phone %D 2021 %7 15.9.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: Between 15% and 70% of adolescents report experiencing cybervictimization. Cybervictimization is associated with multiple negative consequences, including depressed mood. Few validated, easily disseminated interventions exist to prevent cybervictimization and its consequences. With over 97% of adolescents using social media (such as YouTube, Facebook, Instagram, or Snapchat), recruiting and delivering a prevention intervention through social media and apps may improve accessibility of prevention tools for at-risk youth. Objective: This study aims to evaluate the feasibility and acceptability of and obtain preliminary outcome data on IMPACT (Intervention Media to Prevent Adolescent Cyber-Conflict Through Technology), a brief, remote app-based intervention to prevent and reduce the effect of cyberbullying. Methods: From January 30, 2020, to May 3, 2020, a national sample of 80 adolescents with a history of past-year cybervictimization was recruited through Instagram for a randomized control trial of IMPACT, a brief, remote research assistant–led intervention and a fully automated app-based program, versus enhanced web-based resources (control). Feasibility and acceptability were measured by consent, daily use, and validated surveys. Although not powered for efficacy, outcomes (victimization, bystander self-efficacy, and well-being) were measured using validated measures at 8 and 16 weeks and evaluated using a series of longitudinal mixed models. Results: Regarding feasibility, 24.5% (121/494) of eligible participants provided contact information; of these, 69.4% (84/121) completed full enrollment procedures. Of the participants enrolled, 45% (36/80) were randomized into the IMPACT intervention and 55% (44/80) into the enhanced web-based resources groups. All participants randomized to the intervention condition completed the remote intervention session, and 89% (77/80) of the daily prompts were answered. The retention rate was 99% (79/80) at 8 weeks and 96% (77/80) at 16 weeks for all participants. Regarding acceptability, 100% (36/36) of the intervention participants were at least moderately satisfied with IMPACT overall, and 92% (33/36) of the participants were at least moderately satisfied with the app. At both 8 and 16 weeks, well-being was significantly higher (β=1.17, SE 0.87, P=.02 at 8 weeks and β=3.24, SE 0.95, P<.001 at 16 weeks) and psychological stress was lower (β=−.66, SE 0.08, P=.04 at 8 weeks and β=−.89, SE 0.09, P<.001 at 16 weeks) among IMPACT users than among control group users. Participants in the intervention group attempted significantly more bystander interventions than those in the control group at 8 weeks (β=.82, SE 0.42; P=.02). Conclusions: This remote app-based intervention for victims of cyberbullying was feasible and acceptable, increased overall well-being and bystander interventions, and decreased psychological stress. Our findings are especially noteworthy given that the trial took place during the COVID-19 pandemic. The use of Instagram to recruit adolescents can be a successful strategy for identifying and intervening with those at the highest risk of cybervictimization. Trial Registration: ClinicalTrials.gov NCT04259216; http://clinicaltrials.gov/ct2/show/NCT04259216. %M 34524103 %R 10.2196/26029 %U https://mental.jmir.org/2021/9/e26029 %U https://doi.org/10.2196/26029 %U http://www.ncbi.nlm.nih.gov/pubmed/34524103 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 9 %P e30802 %T Co-Development of a Web-Based Hub (eSocial-hub) to Combat Social Isolation and Loneliness in Francophone and Anglophone Older People in the Linguistic Minority Context (Quebec, Manitoba, and New Brunswick): Protocol for a Mixed Methods Interventional Study %A Beogo,Idrissa %A Ramdé,Jean %A Nguemeleu Tchouaket,Eric %A Sia,Drissa %A Bationo,Nebila Jean-Claude %A Collin,Stephanie %A Anne,Abdoulaye %A Gagnon,Marie-Pierre %+ École des sciences infirmières, Faculté des sciences de la santé, Université d'Ottawa, 451 Smyth Rd, Ottawa, ON, K1H 8M5, Canada, 1 6135625432, ibeogo@uottawa.ca %K older people %K nursing facility %K nursing home %K long-term care home %K linguistic minority %K digital health %K COVID-19 %K social isolation %K loneliness %K older adults %K development %K isolation %K minority %K community %D 2021 %7 15.9.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: The first wave of the COVID-19 pandemic has severely hit Canadian nursing facilities (81% of deaths). To this toll, public health measures (eg, visitation restriction) have subsequently deepened the social isolation and loneliness of residents in nursing facilities (NFs), especially those in linguistic minority settings: Anglophone institutions in Quebec and Francophone institutions outside Quebec. However, very few COVID-19 initiatives targeting these populations specifically have been documented. Given the limited number of NFs serving linguistic minorities in Canadian populations, families and loved ones often live far from these facilities, sometimes even in other provinces. This context places the digital solutions as particularly relevant for the present COVID-19 pandemic as well as in the post–COVID-19 era. Objective: This project aims to co-develop a virtual community of practice through a web-based platform (eSocial-hub) to combat social isolation and loneliness among the older people in linguistic minority settings in Canada. Methods: An interventional study using a sequential mixed methods design will be conducted. Four purposely selected NFs will be included, 2 among facilities in Manitoba and 2 in New Brunswick; and 2 Anglophone NFs in Quebec will serve as knowledge users. The development of eSocial-hub will include an experimental 4-month phase involving the following end users: (1) older people (n=3 per NF), (2) families of the participating older people (n=3 per NF), and (3) frontline staff (nurse and health care aid; n=2 per NF). Results: Activities and solutions aiming at reducing social isolation and loneliness will be implemented and then evaluated with the project stakeholders, and the best practices generated. The assessment will be conducted using indicators derived from the 5 domains of the Consolidated Framework for Implementation Research. The project will be led by an interdisciplinary team and will involve a multisectoral partnership. Conclusions: The project will develop a promising and generalizable solution that uses virtual technology to help reduce social isolation and loneliness among the older people. International Registered Report Identifier (IRRID): PRR1-10.2196/30802 %M 34464326 %R 10.2196/30802 %U https://www.researchprotocols.org/2021/9/e30802 %U https://doi.org/10.2196/30802 %U http://www.ncbi.nlm.nih.gov/pubmed/34464326 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 9 %P e31621 %T Pediatric Weight Management Through mHealth Compared to Face-to-Face Care: Cost Analysis of a Randomized Control Trial %A Tully,Louise %A Sorensen,Jan %A O'Malley,Grace %+ Obesity Research and Care Group, Division of Population Health Sciences, School of Physiotherapy, Royal College of Surgeons in Ireland, University of Medicine and Health Sciences, Beaux Lane House, Level -1, Mercer St, Dublin, D02 DH60, Ireland, 353 014022100, louisetully@rcsi.com %K childhood obesity %K pediatric weight management %K economic evaluation %K digital health %K telemedicine %K mHealth %D 2021 %7 14.9.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mobile health (mHealth) may improve pediatric weight management capacity and the geographical reach of services, and overcome barriers to attending physical appointments using ubiquitous devices such as smartphones and tablets. This field remains an emerging research area with some evidence of its effectiveness; however, there is a scarcity of literature describing economic evaluations of mHealth interventions. Objective: We aimed to assess the economic viability of using an mHealth approach as an alternative to standard multidisciplinary care by evaluating the direct costs incurred within treatment arms during a noninferiority randomized controlled trial (RCT). Methods: A digitally delivered (via a smartphone app) maintenance phase of a pediatric weight management program was developed iteratively with patients and families using evidence-based approaches. We undertook a microcosting exercise and budget impact analysis to assess the costs of delivery from the perspective of the publicly funded health care system. Resource use was analyzed alongside the RCT, and we estimated the costs associated with the staff time and resources for service delivery per participant. Results: In total, 109 adolescents participated in the trial, and 84 participants completed the trial (25 withdrew from the trial). We estimated the mean direct cost per adolescent attending usual care at €142 (SD 23.7), whereas the cost per adolescent in the mHealth group was €722 (SD 221.1), with variations depending on the number of weeks of treatment completion. The conversion rate for the reference year 2013 was $1=€0.7525. The costs incurred for those who withdrew from the study ranged from €35 to €681, depending on the point of dropout and study arm. The main driver of the costs in the mHealth arm was the need for health professional monitoring and support for patients on a weekly basis. The budget impact for offering the mHealth intervention to all newly referred patients in a 1-year period was estimated at €59,046 using the assessed approach. Conclusions: This mHealth approach was substantially more expensive than usual care, although modifications to the intervention may offer opportunities to reduce the mHealth costs. The need for monitoring and support from health care professionals (HCPs) was not eliminated using this delivery model. Further research is needed to explore the cost-effectiveness and economic impact on families and from a wider societal perspective. Trial Registration: ClinicalTrials.gov NCT01804855; https://clinicaltrials.gov/ct2/show/NCT01804855 %M 34519665 %R 10.2196/31621 %U https://mhealth.jmir.org/2021/9/e31621 %U https://doi.org/10.2196/31621 %U http://www.ncbi.nlm.nih.gov/pubmed/34519665 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e25486 %T Promoting Physical Activity Through Conversational Agents: Mixed Methods Systematic Review %A Luo,Tiffany Christina %A Aguilera,Adrian %A Lyles,Courtney Rees %A Figueroa,Caroline Astrid %+ School of Social Welfare, University of California, Berkeley, Haviland Hall, Berkeley, CA, 94720-7400, United States, 1 650 228 3514, tiffany.luo@berkeley.edu %K physical activity %K health behavior %K behavior change %K conversational agent %K virtual agent %K chatbot %K digital health %K eHealth %K mHealth %K mobile health %K mobile phone %D 2021 %7 14.9.2021 %9 Review %J J Med Internet Res %G English %X Background: Regular physical activity (PA) is crucial for well-being; however, healthy habits are difficult to create and maintain. Interventions delivered via conversational agents (eg, chatbots or virtual agents) are a novel and potentially accessible way to promote PA. Thus, it is important to understand the evolving landscape of research that uses conversational agents. Objective: This mixed methods systematic review aims to summarize the usability and effectiveness of conversational agents in promoting PA, describe common theories and intervention components used, and identify areas for further development. Methods: We conducted a mixed methods systematic review. We searched seven electronic databases (PsycINFO, PubMed, Embase, CINAHL, ACM Digital Library, Scopus, and Web of Science) for quantitative, qualitative, and mixed methods studies that conveyed primary research on automated conversational agents designed to increase PA. The studies were independently screened, and their methodological quality was assessed using the Mixed Methods Appraisal Tool by 2 reviewers. Data on intervention impact and effectiveness, treatment characteristics, and challenges were extracted and analyzed using parallel-results convergent synthesis and narrative summary. Results: In total, 255 studies were identified, 7.8% (20) of which met our inclusion criteria. The methodological quality of the studies was varied. Overall, conversational agents had moderate usability and feasibility. Those that were evaluated through randomized controlled trials were found to be effective in promoting PA. Common challenges facing interventions were repetitive program content, high attrition, technical issues, and safety and privacy concerns. Conclusions: Conversational agents hold promise for PA interventions. However, there is a lack of rigorous research on long-term intervention effectiveness and patient safety. Future interventions should be based on evidence-informed theories and treatment approaches and should address users’ desires for program variety, natural language processing, delivery via mobile devices, and safety and privacy concerns. %M 34519653 %R 10.2196/25486 %U https://www.jmir.org/2021/9/e25486 %U https://doi.org/10.2196/25486 %U http://www.ncbi.nlm.nih.gov/pubmed/34519653 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 9 %P e25294 %T A Suite of Mobile Conversational Agents for Daily Stress Management (Popbots): Mixed Methods Exploratory Study %A Mauriello,Matthew Louis %A Tantivasadakarn,Nantanick %A Mora-Mendoza,Marco Antonio %A Lincoln,Emmanuel Thierry %A Hon,Grace %A Nowruzi,Parsa %A Simon,Dorien %A Hansen,Luke %A Goenawan,Nathaniel H %A Kim,Joshua %A Gowda,Nikhil %A Jurafsky,Dan %A Paredes,Pablo Enrique %+ Stanford School of Medicine, Stanford University, 291 Campus Drive, Stanford, CA, 94305, United States, 1 650 723 2300, pparedes@stanford.edu %K conversational agents %K virtual agent %K chatbot %K therapy %K stress relief %K stress management %K mental health %K stress %K exploratory %K support %K mobile phone %D 2021 %7 14.9.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Approximately 60%-80% of the primary care visits have a psychological stress component, but only 3% of patients receive stress management advice during these visits. Given recent advances in natural language processing, there is renewed interest in mental health chatbots. Conversational agents that can understand a user’s problems and deliver advice that mitigates the effects of daily stress could be an effective public health tool. However, such systems are complex to build and costly to develop. Objective: To address these challenges, our aim is to develop and evaluate a fully automated mobile suite of shallow chatbots—we call them Popbots—that may serve as a new species of chatbots and further complement human assistance in an ecosystem of stress management support. Methods: After conducting an exploratory Wizard of Oz study (N=14) to evaluate the feasibility of a suite of multiple chatbots, we conducted a web-based study (N=47) to evaluate the implementation of our prototype. Each participant was randomly assigned to a different chatbot designed on the basis of a proven cognitive or behavioral intervention method. To measure the effectiveness of the chatbots, the participants’ stress levels were determined using self-reported psychometric evaluations (eg, web-based daily surveys and Patient Health Questionnaire-4). The participants in these studies were recruited through email and enrolled on the web, and some of them participated in follow-up interviews that were conducted in person or on the web (as necessary). Results: Of the 47 participants, 31 (66%) completed the main study. The findings suggest that the users viewed the conversations with our chatbots as helpful or at least neutral and came away with increasingly positive sentiment toward the use of chatbots for proactive stress management. Moreover, those users who used the system more often (ie, they had more than or equal to the median number of conversations) noted a decrease in depression symptoms compared with those who used the system less often based on a Wilcoxon signed-rank test (W=91.50; Z=−2.54; P=.01; r=0.47). The follow-up interviews with a subset of the participants indicated that half of the common daily stressors could be discussed with chatbots, potentially reducing the burden on human coping resources. Conclusions: Our work suggests that suites of shallow chatbots may offer benefits for both users and designers. As a result, this study’s contributions include the design and evaluation of a novel suite of shallow chatbots for daily stress management, a summary of benefits and challenges associated with random delivery of multiple conversational interventions, and design guidelines and directions for future research into similar systems, including authoring chatbot systems and artificial intelligence–enabled recommendation algorithms. %M 34519655 %R 10.2196/25294 %U https://formative.jmir.org/2021/9/e25294 %U https://doi.org/10.2196/25294 %U http://www.ncbi.nlm.nih.gov/pubmed/34519655 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e28349 %T Acceptability of a Brief Web-Based Theory-Based Intervention to Prevent and Reduce Self-harm: Mixed Methods Evaluation %A Keyworth,Chris %A O'Connor,Rory %A Quinlivan,Leah %A Armitage,Christopher J %+ School of Psychology, University of Leeds, Woodhouse, Leeds, LS2 9JT, United Kingdom, 44 01133433738, c.keyworth@leeds.ac.uk %K self-harm %K implementation intentions %K acceptability %K online %K volitional help sheet %K digital health %K mental health %D 2021 %7 14.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The volitional help sheet (VHS) for self-harm equips people with a means of responding automatically to triggers for self-harm with coping strategies. Although there is some evidence of its efficacy, improving acceptability and making the intervention available in a web-based format may be crucial to increasing effectiveness and reach. Objective: This study aims to use the Theoretical Framework of Acceptability (TFA) to explore the acceptability of the VHS, examine for whom and under what circumstances this intervention is more or less acceptable, and develop a series of recommendations for how the VHS can be used to support people in reducing repeat self-harm. Methods: We explored acceptability in two phases. First, our patient and public involvement partners evaluated the original VHS from a lived experience perspective, which was subsequently translated into a web-based format. Second, a representative sample of adults in the United Kingdom who had previously self-harmed were recruited via a YouGov survey (N=514) and were asked to rate the acceptability of the VHS based on the seven constructs of the TFA, namely, affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy. Data were analyzed using descriptive statistics, one-tailed t tests, and binary logistic regression. A directed content analysis approach was used to analyze qualitative data. Results: Participants in the web-based survey rated the VHS as positive (affective attitude; t457=4.72; P<.001); were confident using it (self-efficacy; t457=9.54; P<.001); felt they did not have to give up any benefits, profits, or values when using it (opportunity costs; t439=−15.51; P<.001); understood it and how it worked (intervention coherence; t464=11.90; P<.001); and were confident that it would achieve its purpose (perceived effectiveness; t466=2.04; P=.04). The TFA domain burden appeared to be an important indicator of acceptability. Lower levels of perceived burden when using the VHS tool were more prevalent among younger adults aged 18-24 years (OR 3.63, 95% CI 1.50-8.78), people of White ethnic background (OR 3.02, 95% CI 1.06-8.613), and people without a long-term health condition (OR 1.53, 95% CI 1.01-2.30). Perceived modifications to further improve acceptability included improved formatting (burden), the feature to add new situations and responses or amend existing ones (ethicality), and clearer instructions and further detail about the purpose of the VHS (intervention coherence). Conclusions: Our findings show high levels of acceptability among some people who have previously self-harmed, particularly among younger adults, people of White ethnic backgrounds, and people without long-term health conditions. Future research should aim to improve acceptability among older adults, people from minority ethnic groups, and people with long-term health conditions. %M 34518153 %R 10.2196/28349 %U https://www.jmir.org/2021/9/e28349 %U https://doi.org/10.2196/28349 %U http://www.ncbi.nlm.nih.gov/pubmed/34518153 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e26315 %T Smartphone-Based Interventions to Reduce Sedentary Behavior and Promote Physical Activity Using Integrated Dynamic Models: Systematic Review %A Daryabeygi-Khotbehsara,Reza %A Shariful Islam,Sheikh Mohammed %A Dunstan,David %A McVicar,Jenna %A Abdelrazek,Mohamed %A Maddison,Ralph %+ Institute for Physical Activity and Nutrition, Deakin University, 75 Pigdons Road, Waurn Ponds Victoria, Geelong, 3216, Australia, 61 3 924 45936, reza.d@deakin.edu.au %K smartphone %K mobile phone %K physical activity %K sedentary behavior %K computational models %K control systems %K systematic review %D 2021 %7 13.9.2021 %9 Review %J J Med Internet Res %G English %X Background: Traditional psychological theories are inadequate to fully leverage the potential of smartphones and improve the effectiveness of physical activity (PA) and sedentary behavior (SB) change interventions. Future interventions need to consider dynamic models taken from other disciplines, such as engineering (eg, control systems). The extent to which such dynamic models have been incorporated in the development of interventions for PA and SB remains unclear. Objective: This review aims to quantify the number of studies that have used dynamic models to develop smartphone-based interventions to promote PA and reduce SB, describe their features, and evaluate their effectiveness where possible. Methods: Databases including PubMed, PsycINFO, IEEE Xplore, Cochrane, and Scopus were searched from inception to May 15, 2019, using terms related to mobile health, dynamic models, SB, and PA. The included studies involved the following: PA or SB interventions involving human adults; either developed or evaluated integrated psychological theory with dynamic theories; used smartphones for the intervention delivery; the interventions were adaptive or just-in-time adaptive; included randomized controlled trials (RCTs), pilot RCTs, quasi-experimental, and pre-post study designs; and were published from 2000 onward. Outcomes included general characteristics, dynamic models, theory or construct integration, and measured SB and PA behaviors. Data were synthesized narratively. There was limited scope for meta-analysis because of the variability in the study results. Results: A total of 1087 publications were screened, with 11 publications describing 8 studies included in the review. All studies targeted PA; 4 also included SB. Social cognitive theory was the major psychological theory upon which the studies were based. Behavioral intervention technology, control systems, computational agent model, exploit-explore strategy, behavioral analytic algorithm, and dynamic decision network were the dynamic models used in the included studies. The effectiveness of quasi-experimental studies involved reduced SB (1 study; P=.08), increased light PA (1 study; P=.002), walking steps (2 studies; P=.06 and P<.001), walking time (1 study; P=.02), moderate-to-vigorous PA (2 studies; P=.08 and P=.81), and nonwalking exercise time (1 study; P=.31). RCT studies showed increased walking steps (1 study; P=.003) and walking time (1 study; P=.06). To measure activity, 5 studies used built-in smartphone sensors (ie, accelerometers), 3 of which used the phone’s GPS, and 3 studies used wearable activity trackers. Conclusions: To our knowledge, this is the first systematic review to report on smartphone-based studies to reduce SB and promote PA with a focus on integrated dynamic models. These findings highlight the scarcity of dynamic model–based smartphone studies to reduce SB or promote PA. The limited number of studies that incorporate these models shows promising findings. Future research is required to assess the effectiveness of dynamic models in promoting PA and reducing SB. Trial Registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42020139350; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=139350. %M 34515637 %R 10.2196/26315 %U https://www.jmir.org/2021/9/e26315 %U https://doi.org/10.2196/26315 %U http://www.ncbi.nlm.nih.gov/pubmed/34515637 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e29672 %T Efficacy of a Single-Session “Empowered Relief” Zoom-Delivered Group Intervention for Chronic Pain: Randomized Controlled Trial Conducted During the COVID-19 Pandemic %A Ziadni,Maisa S %A Gonzalez-Castro,Lluvia %A Anderson,Steven %A Krishnamurthy,Parthasarathy %A Darnall,Beth D %+ Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, 1070 Arastradero Road, Palo Alto, CA, 94304, United States, 1 6507365494, mziadni@stanford.edu %K single-session %K empowered relief %K Zoom-delivered %K pain catastrophizing %K pain intensity %K randomized-controlled trial %K chronic pain %D 2021 %7 10.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Cognitive behavioral therapy–pain is an evidence-based treatment for chronic pain that can have significant patient burden, including health care cost, travel, multiple sessions, and lack of access in remote areas. Objective: The study aims to pilot test the efficacy of a single-session videoconference-delivered empowered relief (ER) intervention compared to waitlist control (WLC) conditions among individuals with chronic pain. We hypothesized that ER would be superior to WLC in reducing pain catastrophizing, pain intensity, and other pain-related outcomes at 1-3 months posttreatment. Methods: We conducted a randomized controlled trial involving a web-based sample of adults (N=104) aged 18-80 years with self-reported chronic pain. Participants were randomized (1:1) to 1 of 2 unblinded study groups: ER (50/104, 48.1%) and WLC (54/104, 51.9%). Participants allocated to ER completed a Zoom-delivered class, and all participants completed follow-up surveys at 2 weeks and 1, 2, and 3 months posttreatment. All the study procedures were performed remotely and electronically. The primary outcome was pain catastrophizing 1-month posttreatment, with pain intensity, pain bothersomeness, and sleep disruption as secondary outcomes. We also report a more rigorous test of the durability of treatment effects at 3 months posttreatment. Data were collected from September 2020 to February 2021 and analyzed using intention-to-treat analysis. The analytic data set included participants (18/101, 17.8% clinic patients; 83/101, 82.1% community) who completed at least one study survey: ER (50/101, 49.5%) and WLC (51/104, 49%). Results: Participants (N=101) were 69.3% (70/101) female, with a mean age of 49.76 years (SD 13.90; range 24-78); 32.7% (33/101) had an undergraduate degree and self-reported chronic pain for 3 months. Participants reported high engagement (47/50, 94%), high satisfaction with ER (mean 8.26, SD 1.57; range 0-10), and high satisfaction with the Zoom platform (46/50, 92%). For the between-groups factor, ER was superior to WLC for all primary and secondary outcomes at 3 months posttreatment (highest P<.001), and between-groups Cohen d effect sizes ranged from 0.45 to 0.79, indicating that the superiority was of moderate to substantial clinical importance. At 3 months, clinically meaningful pain catastrophizing scale (PCS) reductions were found for ER but not for WLC (ER: PCS −8.72, 42.25% reduction; WLC: PCS −2.25, 11.13% reduction). ER resulted in significant improvements in pain intensity, sleep disturbance, and clinical improvements in pain bothersomeness. Conclusions: Zoom-delivered ER had high participant satisfaction and very high engagement. Among adults with chronic pain, this single-session, Zoom-delivered, skills-based pain class resulted in clinically significant improvement across a range of pain-related outcomes that was sustained at 3 months. Web-based delivery of ER could allow greater accessibility of home-based pain treatment and could address the inconveniences and barriers faced by patients when attempting to receive in-person care. Trial Registration: ClinicalTrials.gov NCT04546685; https://clinicaltrials.gov/ct2/show/NCT04546685 %M 34505832 %R 10.2196/29672 %U https://www.jmir.org/2021/9/e29672 %U https://doi.org/10.2196/29672 %U http://www.ncbi.nlm.nih.gov/pubmed/34505832 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 9 %P e30367 %T Adapting to the Pandemic: Protocol of a Web-Based Perinatal Health Study to Improve Maternal and Infant Outcomes %A Tzilos Wernette,Golfo %A Countryman,Kristina %A Mmeje,Okeoma %A Ngo,Quyen M %A Zlotnick,Caron %+ Department of Family Medicine, University of Michigan Medical School, 1018 Fuller Street, Ann Arbor, MI, 48104, United States, 1 17349987120, gtzilos@med.umich.edu %K COVID-19 %K pregnancy %K COVID-19 pandemic %K alcohol use %K drug use %K sexually transmitted infections %K technology-delivered interventions %D 2021 %7 10.9.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: The identification of interconnected health risks during the perinatal period offers an opportunity to prevent negative maternal and infant health outcomes. Marijuana, opioid, and other substance use during pregnancy is a rapidly growing public health concern with significant and costly health consequences for the woman and the developing fetus. Pregnant persons who misuse substances are disproportionately more likely to engage in risky sexual behaviors resulting in sexually transmitted infections (STIs), which are on the rise in this population and can lead to adverse effects on maternal health and on fetal development. Objective: Our goal is to continue testing an innovative and low-cost technology-delivered intervention, the Health Check-Up for Expectant Moms (HCEM), which simultaneously targets alcohol and drug use and STI risk during pregnancy, both of which are on the rise during the COVID-19 pandemic. Methods: We describe the ways in which we have adapted the web-based HCEM intervention to continue recruitment and study enrollment during the pandemic. Results: Study recruitment, visits, and participant safety assessments were all successfully modified during the initial year of the COVID-19 pandemic. Compared to in-person recruitment that occurred prepandemic, remote recruitment yielded a greater proportion of women enrolled in the study (83/136, 61.0% vs 43/52, 83%) in a shorter period (12 months vs 7 months). Conclusions: Despite study challenges related to the pandemic, including time and effort adapting to a remote protocol, remote recruitment and visits for this study were found to constitute a successful approach. Trial Registration: ClinicalTrials.gov NCT03826342; https://clinicaltrials.gov/ct2/show/NCT03826342 International Registered Report Identifier (IRRID): DERR1-10.2196/30367 %M 34351867 %R 10.2196/30367 %U https://www.researchprotocols.org/2021/9/e30367 %U https://doi.org/10.2196/30367 %U http://www.ncbi.nlm.nih.gov/pubmed/34351867 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 3 %P e25751 %T Evaluation of the Low Carb Program Digital Intervention for the Self-Management of Type 2 Diabetes and Prediabetes in an NHS England General Practice: Single-Arm Prospective Study %A Summers,Charlotte %A Tobin,Simon %A Unwin,David %+ DDM Health, Technology House, Science Park, University of Warwick, Coventry, CV4 7EZ, United Kingdom, 44 7969091134, Charlotte@ddm.health %K Low Carb Program %K low carbohydrate %K diabetes %K type 2 diabetes intervention %K diabetes prevention %K self-management %K behavior change %K prediabetes %D 2021 %7 9.9.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Type 2 diabetes mellitus has serious health consequences, including blindness, amputation, and stroke. Researchers and clinicians are increasingly in agreement that type 2 diabetes may be effectively treated with a carbohydrate-reduced diet. Digital apps are increasingly used as an adjunct to traditional health care provisions to support remote self-management of long-term health conditions. Objective: Our objective was to evaluate the real-world 12-month outcomes of patients prescribed the Low Carb Program digital health intervention at a primary care National Health Service (NHS) site. The Low Carb Program is a nutritionally focused, 12-session, digitally delivered, educational behavior change intervention for glycemic control and weight loss for adults with prediabetes and type 2 diabetes. The program educates and supports sustainable dietary changes focused on carbohydrate restriction by utilizing behavior change techniques, including goal setting, peer support, and behavioral self-monitoring, as well as personalized downloadable resources, including recipes and meal plans tailored to ethnicity, weekly shopping budget, and dietary preferences. Methods: This study evaluated the real-world outcomes of patients recruited to the Low Carb Program at an NHS general practice in Southport, United Kingdom. All of the NHS patients recruited to the program were diagnosed with type 2 diabetes or prediabetes and were given access to the program at no cost. A total of 45 participants, with a mean age of 54.8 years (SD 13.2), were included in the study. Women made up 42% (19/45) of the sample. The mean hemoglobin A1c (HbA1c) of the sample was 56.7 mmol/mol (SD 16.95) and the mean body weight was 89.4 kg (SD 13.8). Results: Of the 45 study participants recruited to the program, all of them (100%) activated their accounts and 37 (82%) individuals reported outcomes at 12 months. All 45 (100%) patients completed at least 40% of the lessons and 32 (71%) individuals completed more than nine out of 12 core lessons of the program. Glycemic control and weight loss improved, particularly for participants who completed more than nine core lessons in the program over 12 months. The mean HbA1c went from 58.8 mmol/mol at baseline to 54.0 mmol/mol, representing a mean reduction of 4.78 mmol/mol (SD 4.60; t31=5.87; P<.001). Results showed an average total body weight reduction of 4.17%, with an average weight reduction of 3.85 kg (SD 2.49; t31=9.27; P<.001) at the 12-month follow-up point. Conclusions: A digital app prescribed to adults with type 2 diabetes and prediabetes in a primary care setting supporting a transition to a low-carbohydrate diet has been shown to be effective in improving glycemic control and enabling weight loss. Further research to understand more about factors affecting engagement with the app and further positive health implications would be valuable. %M 34499035 %R 10.2196/25751 %U https://diabetes.jmir.org/2021/3/e25751 %U https://doi.org/10.2196/25751 %U http://www.ncbi.nlm.nih.gov/pubmed/34499035 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e27162 %T Effectiveness of a Dyadic Buddy App for Smoking Cessation: Randomized Controlled Trial %A Schwaninger,Philipp %A Berli,Corina %A Scholz,Urte %A Lüscher,Janina %+ Applied Social and Health Psychology, Department of Psychology, University of Zurich, Binzmühlestrasse 14/14, Zurich, 8050, Switzerland, 41 44 635 72 25, philipp.schwaninger@psychologie.uzh.ch %K mHealth %K smartphone app %K smoking cessation %K buddy %K social support %K mobile phone %D 2021 %7 9.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Tobacco smoking is one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real time. This randomized controlled trial investigated the effectiveness of an app that encourages individuals to quit smoking with the help of a social network member (buddy) in daily life. Objective: The objective of this study is to test the effectiveness of the SmokeFree buddy app compared with a control group with self-reported smoking abstinence and carbon monoxide (CO)–verified smoking abstinence as primary outcomes and self-reports of smoked cigarettes per day (CPD) as a secondary outcome. Methods: A total of 162 adults who smoked participated in this single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Around a self-set quit date (ie, 7 days before the self-set quit date and 20 days after) and 6 months later, participants of the intervention and control groups reported on daily smoking abstinence and CPD in end-of-day diaries. Daily smoking abstinence was verified via daily exhaled CO assessments. This assessment was administered via an app displaying results of exhaled CO, thus addressing self-monitoring in both groups. In addition, participants in the intervention group used the SmokeFree buddy app, a multicomponent app that facilitates social support from a buddy of choice. Results: A significant reduction in CPD from baseline to the 6-month follow-up was observed among participants in both groups. Multilevel analyses revealed no significant intervention effect on self-reported and CO-verified daily smoking abstinence at the quit date and 3 weeks later. However, CPD was lower at the quit date and 3 weeks later in the intervention group than in the control group. No significant differences between groups were found for any outcome measures 6 months after the quit date. Overall, low app engagement and low perceived usefulness were observed. Conclusions: Despite some encouraging short-term findings on the amount of smoking, the SmokeFree buddy app did not have beneficial effects on smoking abstinence over and above the self-monitoring control condition. Future studies should examine whether and what support processes can be effectively stimulated and how app use can be improved to better achieve this goal. Trial Registration: ISRCTN Registry 11154315; https://www.isrctn.com/ISRCTN11154315 International Registered Report Identifier (IRRID): RR2-10.1186/s12889-019-7723-z %M 34499045 %R 10.2196/27162 %U https://www.jmir.org/2021/9/e27162 %U https://doi.org/10.2196/27162 %U http://www.ncbi.nlm.nih.gov/pubmed/34499045 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e26434 %T Developing an Asthma Self-management Intervention Through a Web-Based Design Workshop for People With Limited Health Literacy: User-Centered Design Approach %A Salim,Hani %A Lee,Ping Yein %A Sharif-Ghazali,Sazlina %A Cheong,Ai Theng %A Wong,Jasmine %A Young,Ingrid %A Pinnock,Hilary %A , %+ NIHR Global Health Research Unit on Respiratory Health (RESPIRE), Usher Institute, The University of Edinburgh, Old Medical School, Doorway 3, Teviot Place, Edinburgh, EH8 9AG, United Kingdom, 44 0131 650 94, hilary.pinnock@ed.ac.uk %K asthma %K self-management %K design sprint %K health literacy %K mobile phone %D 2021 %7 9.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Technology, including mobile apps, has the potential to support self-management of long-term conditions and can be tailored to enhance adoption. We developed an app to support asthma self-management among people with limited health literacy in a web-based workshop (to ensure physical distancing during the COVID-19 pandemic). Objective: The aim of this study is to develop and test a prototype asthma self-management mobile app tailored to the needs of people with limited health literacy through a web-based workshop. Methods: We recruited participants from a primary care center in Malaysia. We adapted a design sprint methodology to a web-based workshop in five stages over 1 week. Patients with asthma and limited health literacy provided insights into real-life self-management issues in stage 1, which informed mobile app development in stages 2-4. We recruited additional patients to test the prototype in stage 5 using a qualitative research design. Participants gave feedback through a concurrent thinking-aloud process moderated by a researcher. Each interview lasted approximately 1 hour. Screen recordings of app browsing activities were performed. Interviews were audio-recorded and analyzed using a thematic approach to identify utility and usability issues. Results: The stakeholder discussion identified four themes: individual, family, friends, and society and system levels. Five patients tested the prototype. Participants described 4 ways in which the app influenced or supported self-management (utility): offering information, providing access to an asthma action plan, motivating control of asthma through support for medication adherence, and supporting behavior change through a reward system. Specific usability issues addressed navigation, comprehension, and layout. Conclusions: This study proved that it was possible to adapt the design sprint workshop to a web-based format with the added advantage that it allowed the development and the testing process to be done efficiently through various programs. The resultant app incorporated advice from stakeholders, including sources for information about asthma, medication and appointment reminders, accessible asthma action plans, and sources for social support. The app is now ready to move to feasibility testing. %M 34499039 %R 10.2196/26434 %U https://www.jmir.org/2021/9/e26434 %U https://doi.org/10.2196/26434 %U http://www.ncbi.nlm.nih.gov/pubmed/34499039 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 9 %P e25168 %T Combined Use of Web-Based and In-Person Education on Ill Health Self-management Skills in Adults With Bipolar Disorder: Protocol for a Mixed Methods Study %A Hatzioannou,Anna %A Chatzittofis,Andreas %A Koutroubas,Virginia Sunday %A Papastavrou,Evridiki %A Karanikola,Maria %+ Nursing Department, School of Health Sciences, Cyprus University of Technology, 15 Vragadinou Street, Limassol, 3041, Cyprus, 357 99786069, maria.karanikola@cut.ac.cy %K education %K empowerment %K bipolar disorders %K self-management %K bipolar %K mental health %D 2021 %7 8.9.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Addressing the enhancement of ill health self-management skills in adults diagnosed with bipolar disorder may be considered an important intervention for health care systems worldwide. Objective: This protocol describes the study “Management of my Bipolarity” (MoB), which aims to develop an educational intervention for adults with bipolar disorder and assess its effectiveness. The objectives include (a) a literature review on bipolar disorder educational interventions; (b) a qualitative exploration of the educational needs of people with bipolar disorder; (c) development of an educational intervention based on objectives (a) and (b) (ie, the MoB educational intervention); and (d) exploration of the effectiveness of the intervention regarding participants’ knowledge of their mental health condition and enhancement of their ill health self-management skills. The MoB educational intervention will consist of an in-person and a web-based intervention in the form of a digital platform. Methods: The proposed interventional study is a combination of a qualitative and a quantitative design (mixed methods study). A focus group and content analysis will be implemented for the qualitative assessment of the educational needs of adults with bipolar disorder. The intervention will be developed based on the qualitative data of the study and relevant literature. The effectiveness of the acquired knowledge and self-management skills will be assessed according to (a) substance use behavior, (b) health locus of control, (c) impulse control, (d) adherence to pharmacotherapy, (e) relapse prevention, (f) improvement of quality of life, and (g) bipolar disorder knowledge level via structured instruments in the quantitative part of the study using descriptive and inferential statistics (SPSS version 24.0). Results: A total of 13 patients with bipolar disorder have been interviewed (8 women, 5 men) to identify educational needs to be covered through the intervention. Moreover, a literature review on bipolar disorder educational interventions has been completed. These data have been incorporated in the design of the MoB in-person intervention and the digital platform. The digital platform is live, and the development of the MoB in-person intervention was completed at the end of 2020. The recruitment of the participants for the intervention (40 patients) and the control group (40 patients) began during the first semester of 2021. Moreover, by tracking the platform for 1.5 years, we have recorded that 2180 users have visited the platform with an average session duration of almost 2 minutes. Mobile and tablet devices are being used by 70% of the visitors. Conclusions: Since new parameters regarding educational interventions will be explored, these findings are expected to provide evidence that participation in structured educational interventions offers patients the opportunity to improve adherence to pharmacotherapy and increase their quality of life. Trial Registration: ClinicalTrials.gov NCT04643210; https://clinicaltrials.gov/ct2/show/NCT04643210 International Registered Report Identifier (IRRID): DERR1-10.2196/25168 %M 34494969 %R 10.2196/25168 %U https://www.researchprotocols.org/2021/9/e25168 %U https://doi.org/10.2196/25168 %U http://www.ncbi.nlm.nih.gov/pubmed/34494969 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e26054 %T Effectiveness of a Multistrategy Behavioral Intervention to Increase the Nutritional Quality of Primary School Students’ Web-Based Canteen Lunch Orders (Click & Crunch): Cluster Randomized Controlled Trial %A Wyse,Rebecca %A Delaney,Tessa %A Stacey,Fiona %A Zoetemeyer,Rachel %A Lecathelinais,Christophe %A Lamont,Hannah %A Ball,Kylie %A Campbell,Karen %A Rissel,Chris %A Attia,John %A Wiggers,John %A Yoong,Sze Lin %A Oldmeadow,Christopher %A Sutherland,Rachel %A Nathan,Nicole %A Reilly,Kathryn %A Wolfenden,Luke %+ School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia, 61 49246310, rebecca.wyse@health.nsw.gov.au %K nudge %K choice architecture %K intervention %K online canteen %K online ordering systems %K digital interventions %K school children %K school food service %K canteens %K menu labeling %D 2021 %7 7.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: School food outlets represent a key setting for public health nutrition intervention. The recent proliferation of web-based food ordering systems provides a unique opportunity to support healthy purchasing from schools. Embedding evidence-based choice architecture strategies within these routinely used systems provides the opportunity to impact the purchasing decisions of many users simultaneously and warrants investigation. Objective: This study aims to assess the effectiveness of a multistrategy behavioral intervention implemented via a web-based school canteen lunch ordering system in reducing the energy, saturated fat, sugar, and sodium content of primary students’ web-based lunch orders. Methods: The study used a parallel-group, cohort, cluster randomized controlled trial design with 2207 students from 17 Australian primary schools. Schools with a web-based canteen lunch ordering system were randomly assigned to receive either a multistrategy behavioral intervention that included choice architecture strategies embedded in the web-based system (n=9 schools) or the standard web-based ordering system only (n=8 control schools). Automatically collected student purchasing data at baseline (term 2, 2018) and 12 months later (term 2, 2019) were used to assess trial outcomes. Primary trial outcomes included the mean energy (kJ), saturated fat (g), sugar (g), and sodium (mg) content of student lunch orders. Secondary outcomes included the proportion of all web-based lunch order items classified as everyday, occasional, and caution (based on the New South Wales Healthy School Canteen Strategy) and canteen revenue. Results: From baseline to follow-up, the intervention lunch orders had significantly lower energy content (−69.4 kJ, 95% CI −119.6 to −19.1; P=.01) and saturated fat content (−0.6 g, 95% CI −0.9 to −0.4; P<.001) than the control lunch orders, but they did not have significantly lower sugar or sodium content. There was also a small significant between-group difference in the percentage of energy from saturated fat (−0.9%, 95% CI −1.4% to −0.5%; P<.001) but not in the percentage of energy from sugar (+1.1%, 95% CI 0.2% to 1.9%; P=.02). Relative to control schools, intervention schools had significantly greater odds of having everyday items purchased (odds ratio [OR] 1.7, 95% CI 1.5-2.0; P<.001), corresponding to a 9.8% increase in everyday items, and lower odds of having occasional items purchased (OR 0.7, 95% CI 0.6-0.8; P<.001), corresponding to a 7.7% decrease in occasional items); however, there was no change in the odds of having caution (least healthy) items purchased (OR 0.8, 95% CI 0.7-1.0; P=.05). Furthermore, there was no change in schools’ revenue between groups. Conclusions: Given the evidence of small statistically significant improvements in the energy and saturated fat content, acceptability, and wide reach, this intervention has the potential to influence dietary choices at a population level, and further research is warranted to determine its impact when implemented at scale. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000855224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375075. International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2019-030538 %M 34491207 %R 10.2196/26054 %U https://www.jmir.org/2021/9/e26054 %U https://doi.org/10.2196/26054 %U http://www.ncbi.nlm.nih.gov/pubmed/34491207 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 9 %P e27137 %T Recovery Following Peer and Text Messaging Support After Discharge From Acute Psychiatric Care in Edmonton, Alberta: Controlled Observational Study %A Shalaby,Reham %A Hrabok,Marianne %A Spurvey,Pamela %A Abou El-Magd,Rabab M %A Knox,Michelle %A Rude,Rebecca %A Vuong,Wesley %A Surood,Shireen %A Urichuk,Liana %A Snaterse,Mark %A Greenshaw,Andrew J %A Li,Xin-Min %A Agyapong,Vincent Israel Opoku %+ Department of Psychiatry, University of Alberta, 1E1 Walter Mackenzie Health Sciences Centre, 8440 112 St NW, Edmonton, AB, T6G 2B7, Canada, 1 7807144315, agyapong@ualberta.ca %K peer support %K recovery %K controlled observational study %K inpatients %K mental health %K supportive text messages %D 2021 %7 3.9.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Peer support is an emotional, social, and practical help provided by nonprofessionals to assist others in sustaining health behaviors. Peer support is valued in recovery-oriented models of mental health and is becoming increasingly implemented at the organizational level. Text messaging is a relatively low-cost, high-impact, and easily scalable program that uses existing technology, is devoid of geographic barriers, and is easily accessible to end users. Objective: This study aims to evaluate the effectiveness of an innovative peer support system plus a supportive text messaging program on the recovery of discharged patients from acute psychiatric care. Methods: This prospective, rater blinded, controlled observational study included 181 patients who were discharged from acute psychiatric care. Patients were randomized to one of four conditions: treatment as usual (follow-up care), daily supportive text messages only, peer support only, or peer support plus daily supportive text messages. A standardized self-report measure of recovery (Recovery Assessment Scale [RAS]) was completed at baseline, 6 weeks, 3 months, and 6 months. Descriptive analysis, one-way analysis of variance, and repeated measures multivariate analysis of covariance were used to examine the changes in the RAS among the study groups and over the follow-up time points. Results: A total of 65 patients completed the assessments at each time point. For the overall sample, higher scores were found for the peer support plus text message condition compared with the text message only and treatment as usual condition on several scales (ie, willingness to ask for help and personal confidence and hope) and total score on the RAS, after 6 months of intervention. Conclusions: Peer support plus supportive text messaging seems to result in improved recovery compared with other interventions. It may be advisable to incorporate the two interventions as part of routine practice for patients with psychiatric disorders upon hospital discharge. %M 34477565 %R 10.2196/27137 %U https://formative.jmir.org/2021/9/e27137 %U https://doi.org/10.2196/27137 %U http://www.ncbi.nlm.nih.gov/pubmed/34477565 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 3 %P e17431 %T Health Internet Technology for Chronic Conditions: Review of Diabetes Management Apps %A Sneha,Sweta %A Thalla,Srivarun %A Rischie,Ishaan %A Shahriar,Hossain %+ Kennesaw State University, 560 Parliament Garden Way, Kennesaw, GA, 30144, United States, 1 770 853 0661, ssneha@kennesaw.edu %K chronic disease %K diabetes %K blood glucose %K diabetes management %K mHealth disease apps %K diabetes apps %K best Apple diabetes apps %D 2021 %7 31.8.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Mobile health (mHealth) smartphone apps have shown promise in the self-management of chronic disease. In today’s oversaturated health app market, selection criteria that consumers are employing to choose mHealth apps for disease self-management are of paramount importance. App quality is critical in monitoring disease controls but is often linked to consumer popularity rather than clinical recommendations of effectiveness in disease management. Management of key disease variances can be performed through these apps to increase patient engagement in disease self-management. This paper provides a comprehensive review of features found in mHealth apps frequently used in the self- management of diabetes. Objective: The purpose of this study was to review features of frequently used and high consumer-rated mHealth apps used in the self-management of diabetes. This study aimed to highlight key features of consumer-favored mHealth apps used in the self-management of diabetes. Methods: A 2-fold approach was adopted involving the Apple iOS store and the Google search engine. The primary search was conducted on the Apple iOS store using the term “diabetes apps” (device used: Apple iPad). The top 5 most frequently used mHealth apps were identified and rated by the number of consumer reviews, app ratings, and the presence of key diabetes management features, such as dietary blood glucose, A1C, insulin, physical activity, and prescription medication. A subsequent Google search was conducted using the search term “best Apple diabetes apps.” The top 3 search results—“Healthline,” “Everyday Health,” and “Diabetes Apps–American Diabetes Association”—were explored. Results: In total, 12 mHealth apps were reviewed due to their appearing across 4 evaluated sources. Only 1 health app—Glucose Buddy Diabetes Tracker—appeared as the most frequently used within the Apple iOS store and across the other 3 sources. The OneTouch Reveal app ranked first on the list in the iOS store with 39,000 consumer reviews and a rating of 4.7 out of 5.0 stars but only appeared in 1 of the other 3 sources. Blood glucose tracking was present across all apps, but other disease management features varied in type with at least 3 of the 5 key features being present across the 12 reviewed apps. Subscription cost and integration needs were present in the apps which could impact consumers’ decision to select apps. Although mobile app preference was assessed and defined by the number of consumer reviews and star ratings, there were no scientific standards used in the selection and ranking of the health apps within this study. Conclusions: mHealth apps have shown promise in chronic disease management, but a surge in development of these nonregulated health solutions points to a need for regulation, standardization, and quality control. A governing body of health IT professionals, clinicians, policymakers, payors, and patients could be beneficial in defining health app standards for effective chronic disease management. Variabilities in features, cost, and other aspects of management could be reduced by regulatory uniformity, which would increase patient engagement and improve disease outcomes. %M 34463627 %R 10.2196/17431 %U https://diabetes.jmir.org/2021/3/e17431 %U https://doi.org/10.2196/17431 %U http://www.ncbi.nlm.nih.gov/pubmed/34463627 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 8 %P e26861 %T A Mobile Health App (WYZ) for Engagement in Care and Antiretroviral Therapy Adherence Among Youth and Young Adults Living With HIV: Single-Arm Pilot Intervention Study %A Saberi,Parya %A Lisha,Nadra E %A Erguera,Xavier A %A Hudes,Estie Sid %A Johnson,Mallory O %A Ruel,Theodore %A Neilands,Torsten B %+ Department of Medicine, University of California, San Francisco, 550 16th street, San Francisco, CA, 94143, United States, 1 415 502 1000 ext 17171, Parya.Saberi@ucsf.edu %K youth living with HIV %K mobile health %K mobile app %K engagement in care %K antiretroviral therapy adherence %K pilot %D 2021 %7 31.8.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Youth are globally recognized as being vulnerable to HIV. Younger age has been correlated with worse health outcomes. Mobile health (mHealth) interventions have the potential to interact with youth where they are, using a device they already access. Objective: Using predefined benchmarks, we sought to evaluate the feasibility and acceptability of WYZ, an mHealth app, for improved engagement in care and antiretroviral therapy (ART) adherence among youth and young adults living with HIV. WYZ was designed and developed with input from youth and young adults living with HIV using a human-centered design approach and was based on the information, motivation, and behavioral skills framework to address common barriers to care and ART adherence among youth and young adults living with HIV. Methods: We recruited youth and young adults living with HIV (18-29 years old) from the San Francisco Bay Area to take part in a 6-month pilot trial. Their participation included completing baseline and exit surveys, and participating in seven phone check-ins about their use of WYZ. Results: Youth and young adults living with HIV (N=79) reported high levels of feasibility and acceptability with WYZ use. We met predefined benchmarks for recruitment (79/84, 94%), mean logins per week (5.3), tracking ART adherence (5442/9393, 57.9%), posting chat topics per week (4.8), and app crashes reported per week (0.24). The ease of app download, install, and setup, and comfort with security, privacy, and anonymity were highly rated (all over 91%). Additionally, participants reported high satisfaction for a research project that was remotely conducted. Participants used the app for shorter timeframes compared to the predefined benchmark. Conclusions: We noted high feasibility and acceptability with WYZ. Further research to examine the efficacy of WYZ will enable youth and young adults living with HIV and their providers to make informed decisions when using, recommending, and prescribing the app for improved engagement in HIV care and ART adherence. Trial Registration: ClinicalTrials.gov NCT03587857; https://clinicaltrials.gov/ct2/show/NCT03587857 %M 34463622 %R 10.2196/26861 %U https://formative.jmir.org/2021/8/e26861 %U https://doi.org/10.2196/26861 %U http://www.ncbi.nlm.nih.gov/pubmed/34463622 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 8 %P e21938 %T Effects of the Interactive Web-Based Video “Mon Coeur, Mon BASIC” on Drug Adherence of Patients With Myocardial Infarction: Randomized Controlled Trial %A Bruggmann,Christel %A Adjedj,Julien %A Sardy,Sylvain %A Muller,Olivier %A Voirol,Pierre %A Sadeghipour,Farshid %+ Department of Pharmacy, University Hospital of Geneva, Rue Gabrielle Perret-Gentil 4, Geneva, 1205, Switzerland, 41 796146714, cbruggmann@gmail.com %K acute coronary syndrome %K eHealth %K drug adherence %K mHealth %K mobile phone %D 2021 %7 30.8.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Secondary prevention strategies after acute coronary syndrome (ACS) presentation with the use of drug combinations are essential to reduce the recurrence of cardiovascular events. However, lack of drug adherence is known to be common in this population and to be related to treatment failure. To improve drug adherence, we developed the “Mon Coeur, Mon BASIC” video. This online video has been specifically designed to inform patients about their disease and their current medications. Interactivity has been used to increase patient attention, and the video can also be viewed on smartphones and tablets. Objective: The objective of this study was to assess the long-term impact of an informative web-based video on drug adherence in patients admitted for an ACS. Methods: This randomized study was conducted with consecutive patients admitted to University Hospital of Lausanne for ACS. We randomized patients to an intervention group, which had access to the web-based video and a short interview with the pharmacist, and a control group receiving usual care. The primary outcome was the difference in drug adherence, assessed with the Adherence to Refills and Medication Scale (ARMS; 9 multiple-choice questions, scores ranging from 12 for perfect adherence to 48 for lack of adherence), between groups at 1, 3, and 6 months. We assessed the difference in ARMS score between both groups with the Wilcoxon rank sum test. Secondary outcomes were differences in knowledge, readmissions, and emergency room visits between groups and patients’ satisfaction with the video. Results: Sixty patients were included at baseline. The median age of the participants was 59 years (IQR 49-69), and 85% (51/60) were male. At 1 month, 51 patients participated in the follow-up, 50 patients participated at 3 months, and 47 patients participated at 6 months. The mean ARMS scores at 1 and 6 months did not differ between the intervention and control groups (13.24 vs 13.15, 13.52 vs 13.68, respectively). At 3 months, this score was significantly lower in the intervention group than in the control group (12.54 vs 13.75; P=.03). We observed significant increases in knowledge from baseline to 1 and 3 months, but not to 6 months, in the intervention group. Readmissions and emergency room visits have been very rare, and the proportion was not different among groups. Patients in the intervention group were highly satisfied with the video. Conclusions: Despite a lower sample size than we expected to reach, we observed that the “Mon Coeur, Mon BASIC” web-based interactive video improved patients’ knowledge and seemed to have an impact on drug adherence. These results are encouraging, and the video will be offered to all patients admitted to our hospital with ACS. Trial Registration: ClinicalTrials.gov NCT03949608; https://clinicaltrials.gov/ct2/show/NCT03949608 %M 34459744 %R 10.2196/21938 %U https://www.jmir.org/2021/8/e21938 %U https://doi.org/10.2196/21938 %U http://www.ncbi.nlm.nih.gov/pubmed/34459744 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 8 %P e30951 %T Web- and Mindfulness-Based Intervention to Prevent Chronic Pain After Cardiac Surgery: Protocol for a Pilot Randomized Controlled Trial %A Martorella,Geraldine %A Hanley,Adam W %A Pickett,Scott M %A Gelinas,Céline %+ Tallahassee Memorial Healthcare Center for Research and Evidence-Based Practice, College of Nursing, Florida State University, 98 Varsity Way, Tallahassee, FL, 32306, United States, 1 8506446028, gmartorella@fsu.edu %K postoperative pain %K cardiac surgery %K chronic pain %K web-based %K mindfulness %K mobile phone %D 2021 %7 30.8.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cardiac surgery is a frequently performed procedure. However, pain after cardiac surgery may become chronic (lasting >3 months) in adults. Once discharged from the hospital, patients are at greater risk of developing chronic postsurgical pain (CPSP) and of prolonged opioid use, as they need to self-manage their pain. Psychological risk and protective factors such as pain-related catastrophic thoughts and pain acceptance determine their ability to cope and their use of opioids, which is crucial for self-management of pain. Studies on mindfulness-based cognitive therapy (MBCT) have multiplied their potential effects on pain acceptance and catastrophic thoughts. However, web-based MBCT for the prevention of CPSP has not yet been examined. Objective: The aim of this study is to pilot test a 4-week-long web-based MBCT intervention for adults following discharge from the hospital by assessing the acceptability or feasibility of the intervention and examining preliminary effects on pain intensity, pain interference with activities and opioid use, and pain acceptance and catastrophic thoughts in the 6 months following surgery. Methods: A double-blinded pilot randomized controlled trial will be used to assess a web-based MBCT intervention. Patients will be selected according to the following criteria: age ≥18 years; first-time elective cardiac surgery via a median sternotomy; worst pain in the past week score ≥4/10; ability to understand and complete questionnaires in English; and ability to use an electronic device such as a smartphone, computer, or tablet. After baseline measures, 32 participants will be randomized into two groups: one receiving both the brief, 4-week-long web-based MBCT intervention and usual care (experimental group) and the other receiving only one standardized, web-based educational session with weekly reminders and usual care (attention control group). Peer-reviewed competitive funding was received from Florida State University’s Council on Research & Creativity in January 2021, as well as research ethics approval from Florida State University's institutional review board. Results: Recruitment began in June 2021. Unfortunately, because of the current COVID-19 pandemic, recruitment is not progressing as expected. Recruitment strategies are constantly monitored and updated according to latest data and restrictions surrounding the pandemic. Conclusions: This research is significant because it targets the trajectory of CPSP, a leading cause of disability and opioid misuse. This is the first study to assess MBCT for the prevention of CPSP after cardiac surgery in the recovery phase. This approach is innovative because it promotes self-management of pain through the modulation of individual factors. If successful, the intervention could be expanded to numerous populations at risk of chronic pain. International Registered Report Identifier (IRRID): DERR1-10.2196/30951 %M 34459749 %R 10.2196/30951 %U https://www.researchprotocols.org/2021/8/e30951 %U https://doi.org/10.2196/30951 %U http://www.ncbi.nlm.nih.gov/pubmed/34459749 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 8 %P e29061 %T Digital Technology Tools to Examine Patient Adherence to a Prescription-Only Omega-3 Polyunsaturated Fatty Acid Therapy To Mitigate Cardiovascular Risk: Protocol for a Prospective Observational Study and Preliminary Demographic Analysis %A Arutyunov,Gregory P %A Arutyunov,Alexander G %A Ageev,Fail T %A Fofanova,Tatiana V %+ Pirogov Russian National Research Medical University, Department of Internal Medicine, Ostrovityanova Street, Moscow, 117997, Russian Federation, 7 9103281989, arut@ossn.ru %K omega-3-acid ethyl esters %K myocardial infarction %K hypertriglyceridemia %K adherence %K compliance %K persistence %K mHealth %K eHealth %K patient-reported outcomes %D 2021 %7 30.8.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Sustained adherence and persistence with prescription medications is considered essential to achieve maximal treatment benefit for patients with major chronic, noncommunicable diseases such as hyperlipidemia and lipid-associated cardiovascular disease. It is widely documented, however, that many patients with these conditions have poor long-term adherence to their treatments. The population of Russia is affected by poor adherence in the same ways as populations elsewhere and continues to have high rates of cardiovascular disease. Objective: The purpose of this study was to examine patient adherence to a prescription-only preparation of highly purified omega-3 polyunsaturated fatty acids (1.2 to 1 eicosapentaenoic acid to docosahexaenoic ratio, 90% purity) in a large sample of patients at risk for cardiovascular diseases using digital technology to monitor patient behavior and as an outreach facility for patient education and engagement. Methods: We conducted a 6-month prospective observational study (DIAPAsOn) at >100 centers in the Russian Federation. A bespoke electronic data capture and patient engagement system were developed with a well-established Russian technology supplier that enables information obtained during clinic visits to be supplemented by remote patient self-reporting. Other aspects of the program included raising patients' awareness about their condition via educational materials available in personal patient accounts in the electronic system. Results: From an initial cohort of 3000 patients, a safety population of 2572 patients (age: mean 60 years) with an equal proportion of men and women has been characterized. There was widespread concomitant cardiovascular pathology and commensurate use of multiple classes of cardiovascular medication, notably lipid-modifying and antihypertensive drugs. The program was completed by 1975 patients, of whom 780 were prescribed highly purified omega-3 polyunsaturated fatty acid supplements for secondary prevention after myocardial infarction and 1195 were prescribed highly purified omega-3 polyunsaturated fatty acid supplements for hypertriglyceridemia. Data collection and analysis have been completed. Conclusions: DIAPAsOn will provide insights into patient adherence with prescription-grade omega-3 polyunsaturated fatty acid therapy and perspectives on the role of mobile technology in monitoring and encouraging adherence to therapy. %M 34459746 %R 10.2196/29061 %U https://www.researchprotocols.org/2021/8/e29061 %U https://doi.org/10.2196/29061 %U http://www.ncbi.nlm.nih.gov/pubmed/34459746 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 8 %P e27824 %T Informing Patients With Esophagogastric Cancer About Treatment Outcomes by Using a Web-Based Tool and Training: Development and Evaluation Study %A van de Water,Loïs F %A van den Boorn,Héctor G %A Hoxha,Florian %A Henselmans,Inge %A Calff,Mart M %A Sprangers,Mirjam A G %A Abu-Hanna,Ameen %A Smets,Ellen M A %A van Laarhoven,Hanneke W M %+ Department of Medical Oncology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, Amsterdam, , Netherlands, 31 205665955, h.vanlaarhoven@amsterdamumc.nl %K prediction tool %K communication skills training %K shared decision-making %K risk communication %K treatment outcomes %K esophageal cancer %K gastric cancer %K patient-physician communication %D 2021 %7 27.8.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Due to the increasing use of shared decision-making, patients with esophagogastric cancer play an increasingly important role in the decision-making process. To be able to make well-informed decisions, patients need to be adequately informed about treatment options and their outcomes, namely survival, side effects or complications, and health-related quality of life. Web-based tools and training programs can aid physicians in this complex task. However, to date, none of these instruments are available for use in informing patients with esophagogastric cancer about treatment outcomes. Objective: This study aims to develop and evaluate the feasibility of using a web-based prediction tool and supporting communication skills training to improve how physicians inform patients with esophagogastric cancer about treatment outcomes. By improving the provision of treatment outcome information, we aim to stimulate the use of information that is evidence-based, precise, and personalized to patient and tumor characteristics and is communicated in a way that is tailored to individual information needs. Methods: We designed a web-based, physician-assisted prediction tool—Source—to be used during consultations by using an iterative, user-centered approach. The accompanying communication skills training was developed based on specific learning objectives, literature, and expert opinions. The Source tool was tested in several rounds—a face-to-face focus group with 6 patients and survivors, semistructured interviews with 5 patients, think-aloud sessions with 3 medical oncologists, and interviews with 6 field experts. In a final pilot study, the Source tool and training were tested as a combined intervention by 5 medical oncology fellows and 3 esophagogastric outpatients. Results: The Source tool contains personalized prediction models and data from meta-analyses regarding survival, treatment side effects and complications, and health-related quality of life. The treatment outcomes were visualized in a patient-friendly manner by using pictographs and bar and line graphs. The communication skills training consisted of blended learning for clinicians comprising e-learning and 2 face-to-face sessions. Adjustments to improve both training and the Source tool were made according to feedback from all testing rounds. Conclusions: The Source tool and training could play an important role in informing patients with esophagogastric cancer about treatment outcomes in an evidence-based, precise, personalized, and tailored manner. The preliminary evaluation results are promising and provide valuable input for the further development and testing of both elements. However, the remaining uncertainty about treatment outcomes in patients and established habits in doctors, in addition to the varying trust in the prediction models, might influence the effectiveness of the tool and training in daily practice. We are currently conducting a multicenter clinical trial to investigate the impact that the combined tool and training have on the provision of information in the context of treatment decision-making. %M 34448703 %R 10.2196/27824 %U https://www.jmir.org/2021/8/e27824 %U https://doi.org/10.2196/27824 %U http://www.ncbi.nlm.nih.gov/pubmed/34448703 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 8 %P e21686 %T The Effectiveness of a Web-Based Self-Help Program to Reduce Alcohol Use Among Adults With Drinking Patterns Considered Harmful, Hazardous, or Suggestive of Dependence in Four Low- and Middle-Income Countries: Randomized Controlled Trial %A Schaub,Michael P %A Tiburcio,Marcela %A Martínez-Vélez,Nora %A Ambekar,Atul %A Bhad,Roshan %A Wenger,Andreas %A Baumgartner,Christian %A Padruchny,Dzianis %A Osipchik,Sergey %A Poznyak,Vladimir %A Rekve,Dag %A Landi Moraes,Fabricio %A Monezi Andrade,André Luiz %A Oliveira Souza-Formigoni,Maria Lucia %A , %+ Swiss Research Institute for Public Health and Addiction, University of Zurich, Konradstrasse 32, Zurich, 8005, Switzerland, 41 44 448 22 60, michael.schaub@isgf.uzh.ch %K alcohol %K internet %K public health %K self-help %K World Health Organization %D 2021 %7 27.8.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Given the scarcity of alcohol prevention and use disorder treatments in many low- and middle-income countries (LMICs), the World Health Organization has launched an eHealth portal that includes the web-based self-help program “Alcohol e-Health.” Objective: We aimed to test the effectiveness of the Alcohol e-Health program in a randomized controlled trial. Methods: This was a two-arm, individually randomized, and controlled trial across four LMICs comparing the self-help program and a psychoeducation and internet access as usual waiting list. Participants were broadly recruited from community samples in Belarus, Brazil, India, and Mexico from January 2016 through January 2019. The primary outcome measure was change in the Alcohol Use Disorders Identification Test (AUDIT) score with a time frame of 6 months between baseline and follow-up. Secondary outcomes included self-reported numbers of standard drinks over the previous week and cessation of harmful or hazardous drinking (AUDIT score <8). Results: For this study, we recruited 1400 predominantly male (n=982, 70.1%) at least harmful or hazardous alcohol drinkers. The mean age was 37.6 years (SD 10.5). The participants were recruited from Brazil (n=587), Mexico (n=509), India (n=212), and Belarus (n=92). Overall, complete case analysis identified higher AUDIT changes in the intervention group (B=−4.18, 95% CI −5.42 to −2.93, P<.001, d=0.56) that were mirrored by changes in weekly standard drinks (B=−9.34, 95% CI −15.90 to −2.77, P=.005, d=0.28) and cessation rates for harmful or hazardous drinking (χ21=14.56, N=561, P<.001). The supplementary intention-to-treat analyses largely confirmed these initial results. Conclusions: The expansion of the Alcohol e-Health program to other LMICs with underdeveloped alcohol prevention and treatment systems for alcohol use disorders should be considered after successful replication of the present results. Trial Registration: ISRCTN ISRCTN14037475; https://www.isrctn.com/ISRCTN14037475 International Registered Report Identifier (IRRID): RR2-10.1111/add.14034 %M 34448710 %R 10.2196/21686 %U https://www.jmir.org/2021/8/e21686 %U https://doi.org/10.2196/21686 %U http://www.ncbi.nlm.nih.gov/pubmed/34448710 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 8 %P e23978 %T Internet-Based HIV Self-Testing Among Men Who Have Sex With Men Through Pre-exposure Prophylaxis: 3-Month Prospective Cohort Analysis From China %A Zhang,Jing %A Tucker,Joseph %A Tang,Weiming %A Wang,Hongyi %A Chu,Zhenxing %A Hu,Qinghai %A Huang,Xiaojie %A Chen,Yaokai %A Wang,Hui %A He,Xiaoqing %A Li,Yao %A Zhang,Lukun %A Hu,Zhili %A Bao,Rantong %A Li,Shangcao %A Li,Hang %A Ding,Haibo %A Jiang,Yongjun %A Geng,Wenqing %A Xu,Junjie %A Shang,Hong %+ NHC Key Laboratory of AIDS Immunology, National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, No. 155 Nanjingbei Street, Shenyang, 110001, China, 86 83282634, hongshang100@hotmail.com %K HIV self-testing %K men who have sex with men %K pre-exposure prophylaxis %K secondary distribution %K usage %D 2021 %7 27.8.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Routine HIV testing accompanied with pre-exposure prophylaxis (PrEP) requires innovative support in a real-world setting. Objective: This study aimed to determine the usage of HIV self-testing (HIVST) kits and their secondary distribution to partners among men who have sex with men (MSM) in China, who use PrEP, in an observational study between 2018 and 2019. Methods: In 4 major cities in China, we prospectively followed-up MSM from the China Real-world oral PrEP demonstration study, which provides daily or on-demand PrEP for 12 months, to assess the usage and secondary distribution of HIVST on quarterly follow-ups. Half of the PrEP users were randomized to receive 2 HIVSTs per month in addition to quarterly facility-based HIV testing. We evaluated the feasibility of providing HIVST to PrEP users. Results: We recruited 939 MSM and randomized 471 to receive HIVST, among whom 235 (49.9%) were daily and 236 (50.1%) were on-demand PrEP users. At baseline, the median age was 29 years, 390 (82.0%) men had at least college-level education, and 119 (25.3%) had never undergone facility-based HIV testing before. Three months after PrEP initiation, 341 (74.5%) men had used the HIVST provided to them and found it very easy to use. Among them, 180 of 341 (52.8%) men had distributed the HIVST kits it to other MSM, and 132 (51.6%) among the 256 men who returned HIVST results reported that used it with their sexual partners at the onset of intercourse. Participants on daily PrEP were more likely to use HIVST (adjusted hazard ratio=1.3, 95% CI 1.0-1.6) and distribute HIVST kits (adjusted hazard ratio=1.3, 95% CI 1.1-1.7) than those using on-demand PrEP. Conclusions: MSM who used PrEP had a high rate of usage and secondary distribution of HIVST kits, especially among those on daily PrEP, which suggested high feasibility and necessity for HIVST after PrEP initiation. Assuming that fourth-generation HIVST kits are available, HIVST may be able to replace facility-based HIV testing to a certain extent. Trial Registration: Chinese Clinical Trial Registry ChiCTR1800020374; https://www.chictr.org.cn/showprojen.aspx?proj=32481 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2019-036231 %M 34448709 %R 10.2196/23978 %U https://www.jmir.org/2021/8/e23978 %U https://doi.org/10.2196/23978 %U http://www.ncbi.nlm.nih.gov/pubmed/34448709 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 8 %P e26223 %T Factors That Help and Hinder the Implementation of Digital Depression Prevention Programs: School-Based Cross-sectional Study %A Beames,Joanne R %A Johnston,Lara %A O'Dea,Bridianne %A Torok,Michelle %A Christensen,Helen %A Boydell,Katherine M %A Werner-Seidler,Aliza %+ Black Dog Institute, University of New South Wales, Hospital Road, Randwick, 2031, Australia, 61 2 9382 ext 8776, j.beames@blackdog.org.au %K secondary school %K depression %K prevention %K digital %K barrier %K facilitator %K teacher %K counselor %K principal %K student %D 2021 %7 27.8.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital prevention programs that are delivered in a school environment can inoculate young people against depression. However, little is known about the school-based factors that help and hinder the implementation of these programs. Staff members are integral for supporting mental health programs in schools and are likely to have a wealth of expertise and knowledge about the factors that affect implementation. Objective: The primary objective of this study was to explore the barriers and facilitators to implementing a digital depression prevention program in Australian secondary schools with teachers, counselors, and principals. The secondary objective was to explore variations in these factors across different school contexts, including the school type (government or nongovernment), location (capital city, regional/or rural areas), and socioeconomic status (SES) (low, medium, high). Methods: This quantitative cross-sectional survey study assessed the barriers and facilitators to implementing a hypothetical digital prevention program in Australian schools. The survey was taken by 97 teachers (average age 38.3 years), 93 counselors (average age 39.5 years), and 11 principals (average age 50.9 years) across Australia between November 2017 and July 2018. Results: A range of barriers and facilitators relating to logistics and resources, staff support, and program factors were endorsed by the surveyed staff. Consistent with prior research, common barriers included a lack of time and resources (ie, staff and rooms). These barriers were particularly evident in government, rural/regional, and low socioeconomic schools. Other barriers were specific to digital delivery, including privacy issues and a lack of clarity around staff roles and responsibilities. Facilitators included upskilling staff through training, embedding the program into the curriculum, and other program factors including universal delivery, screening of students’ mental health, and clear referral pathways. Knowledge about the program efficacy was also perceived as important by a large proportion of the respondents. Conclusions: The digital depression prevention program was perceived as suitable for use within different schools in Australia, although certain factors need to be considered to enable effective implementation. Logistics and resources, support, and program factors were identified as particularly important for school-based implementation. To maximize the effectiveness in delivering digital programs, implementation may need to be tailored to the staff roles and school types. %M 34448701 %R 10.2196/26223 %U https://www.jmir.org/2021/8/e26223 %U https://doi.org/10.2196/26223 %U http://www.ncbi.nlm.nih.gov/pubmed/34448701 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 8 %P e27709 %T A Machine Learning Approach to Passively Informed Prediction of Mental Health Risk in People with Diabetes: Retrospective Case-Control Analysis %A Yu,Jessica %A Chiu,Carter %A Wang,Yajuan %A Dzubur,Eldin %A Lu,Wei %A Hoffman,Julia %+ Livongo Health, Inc, 150 W Evelyn Ave, Ste 150, Mountain View, CA, 94041, United States, 1 6508048434, jessica.yu@livongo.com %K diabetes mellitus %K mental health %K risk detection %K passive sensing %K ecological momentary assessment %K machine learning %D 2021 %7 27.8.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Proactive detection of mental health needs among people with diabetes mellitus could facilitate early intervention, improve overall health and quality of life, and reduce individual and societal health and economic burdens. Passive sensing and ecological momentary assessment are relatively newer methods that may be leveraged for such proactive detection. Objective: The primary aim of this study was to conceptualize, develop, and evaluate a novel machine learning approach for predicting mental health risk in people with diabetes mellitus. Methods: A retrospective study was designed to develop and evaluate a machine learning model, utilizing data collected from 142,432 individuals with diabetes enrolled in the Livongo for Diabetes program. First, participants’ mental health statuses were verified using prescription and medical and pharmacy claims data. Next, four categories of passive sensing signals were extracted from the participants’ behavior in the program, including demographics and glucometer, coaching, and event data. Data sets were then assembled to create participant-period instances, and descriptive analyses were conducted to understand the correlation between mental health status and passive sensing signals. Passive sensing signals were then entered into the model to train and test its performance. The model was evaluated based on seven measures: sensitivity, specificity, precision, area under the curve, F1 score, accuracy, and confusion matrix. SHapley Additive exPlanations (SHAP) values were computed to determine the importance of individual signals. Results: In the training (and validation) and three subsequent test sets, the model achieved a confidence score greater than 0.5 for sensitivity, specificity, area under the curve, and accuracy. Signals identified as important by SHAP values included demographics such as race and gender, participant’s emotional state during blood glucose checks, time of day of blood glucose checks, blood glucose values, and interaction with the Livongo mobile app and web platform. Conclusions: Results of this study demonstrate the utility of a passively informed mental health risk algorithm and invite further exploration to identify additional signals and determine when and where such algorithms should be deployed. %M 34448707 %R 10.2196/27709 %U https://www.jmir.org/2021/8/e27709 %U https://doi.org/10.2196/27709 %U http://www.ncbi.nlm.nih.gov/pubmed/34448707 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 8 %P e30098 %T Telemental Health For Youth With Chronic Illnesses: Systematic Review %A Lau,Nancy %A Colt,Susannah F %A Waldbaum,Shayna %A O'Daffer,Alison %A Fladeboe,Kaitlyn %A Yi-Frazier,Joyce P %A McCauley,Elizabeth %A Rosenberg,Abby R %+ Palliative Care and Resilience Lab, Center for Clinical and Translational Research, Seattle Children’s Research Institute, 1920 Terry Ave, Seattle, WA, 98101, United States, 1 206 884 0569, nancy.lau@seattlechildrens.org %K telehealth care %K mental health %K psychosocial issues %K psychiatry %K psychology %K child %K chronic disease %D 2021 %7 27.8.2021 %9 Review %J JMIR Ment Health %G English %X Background: Children, adolescents, and young adults with chronic conditions experience difficulties coping with disease-related stressors, comorbid mental health problems, and decreased quality of life. The COVID-19 pandemic has led to a global mental health crisis, and telemental health has necessarily displaced in-person care. However, it remains unknown whether such remote interventions are feasible or efficacious. We aimed to fill this research-practice gap. Objective: In this systematic review, we present a synthesis of studies examining the feasibility and efficacy of telemental health interventions for youth aged ≤25 years with chronic illnesses. Methods: PubMed, Embase, Web of Science, PsycInfo, and Cochrane Database of Systematic Reviews were searched from 2008 to 2020. We included experimental, quasiexperimental, and observational studies of telemental health interventions designed for children, adolescents, and young adults aged ≤25 years with chronic illnesses, in which feasibility or efficacy outcomes were measured. Only English-language publications in peer-reviewed journals were included. We excluded studies of interventions for caregivers or health care providers, mental health problems not in the context of a chronic illness, disease and medication management, and prevention programs for healthy individuals. Results: We screened 2154 unique study records and 109 relevant full-text articles. Twelve studies met the inclusion criteria, and they represented seven unique telemental health interventions. Five of the studies included feasibility outcomes and seven included efficacy outcomes. All but two studies were pilot studies with relatively small sample sizes. Most interventions were based on cognitive behavioral therapy and problem-solving therapy. The subset of studies examining intervention feasibility concluded that telemental health interventions were appropriate, acceptable, and satisfactory to patients and their parents. Technology did not create barriers in access to care. For the subset of efficacy studies, evidence in support of the efficacy of telemental health was mixed. Significant heterogeneity in treatment type, medical diagnoses, and outcomes precluded a meta-analysis. Conclusions: The state of the science for telemental health interventions designed for youth with chronic illnesses is in a nascent stage. Early evidence supports the feasibility of telehealth-based delivery of traditional in-person interventions. Few studies have assessed efficacy, and current findings are mixed. Future research should continue to evaluate whether telemental health may serve as a sustainable alternative to in-person care after the COVID pandemic. %M 34448724 %R 10.2196/30098 %U https://mental.jmir.org/2021/8/e30098 %U https://doi.org/10.2196/30098 %U http://www.ncbi.nlm.nih.gov/pubmed/34448724 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 8 %P e26079 %T Overview and Strategy Analysis of Technology-Based Nonpharmacological Interventions for In-Hospital Delirium Prevention and Reduction: Systematic Scoping Review %A Kim,Chan Mi %A van der Heide,Esther M %A van Rompay,Thomas J L %A Verkerke,Gijsbertus J %A Ludden,Geke D S %+ Department of Design, Production, and Management, Faculty of Engineering Technology, University of Twente, De Horst (Building 20), Enschede, Netherlands, 31 53 489 8450, c.m.kim@utwente.nl %K intensive care unit %K delirium %K delirium prevention %K delirium reduction %K delirium treatment %K technology %K technology-based intervention %K strategy %K nonpharmacological %K systematic scoping review %D 2021 %7 26.8.2021 %9 Review %J J Med Internet Res %G English %X Background: Delirium prevention is crucial, especially in critically ill patients. Nonpharmacological multicomponent interventions for preventing delirium are increasingly recommended and technology-based interventions have been developed to support them. Despite the increasing number and diversity in technology-based interventions, there has been no systematic effort to create an overview of these interventions for in-hospital delirium prevention and reduction. Objective: This systematic scoping review was carried out to answer the following questions: (1) what are the technologies currently used in nonpharmacological technology-based interventions for preventing and reducing delirium? and (2) what are the strategies underlying these currently used technologies? Methods: A systematic search was conducted in Scopus and Embase between 2015 and 2020. A selection was made in line with the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). Studies were eligible if they contained any type of technology-based interventions and assessed delirium-/risk factor–related outcome measures in a hospital setting. Data extraction and quality assessment were performed using a predesigned data form. Results: A total of 31 studies were included and analyzed focusing on the types of technology and the strategies used in the interventions. Our review revealed 8 different technology types and 14 strategies that were categorized into the following 7 pathways: (1) restore circadian rhythm, (2) activate the body, (3) activate the mind, (4) induce relaxation, (5) provide a sense of security, (6) provide a sense of control, and (7) provide a sense of being connected. For all technology types, significant positive effects were found on either or both direct and indirect delirium outcomes. Several similarities were found across effective interventions: using a multicomponent approach or including components comforting the psychological needs of patients (eg, familiarity, distraction, soothing elements). Conclusions: Technology-based interventions have a high potential when multidimensional needs of patients (eg, physical, cognitive, emotional) are incorporated. The 7 pathways pinpoint starting points for building more effective technology-based interventions. Opportunities were discussed for transforming the intensive care unit into a healing environment as a powerful tool to prevent delirium. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020175874; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=175874 %M 34435955 %R 10.2196/26079 %U https://www.jmir.org/2021/8/e26079 %U https://doi.org/10.2196/26079 %U http://www.ncbi.nlm.nih.gov/pubmed/34435955 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 8 %P e23360 %T Development and Evaluation of Acceptability and Feasibility of a Web-Based Intervention for Patients With Bipolar Disorder in Iran: Implementation Study %A Ashrafi,Agaah %A Tabatabaee,Maryam %A Sharifi,Vandad %+ Department of Psychiatry, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Avenue, Roozbeh Hospital, Tehran, Iran, 98 9123875869, vsharifi@tums.ac.ir %K bipolar disorder %K psychoeducation %K web-based intervention %K feasibility %K acceptability %D 2021 %7 17.8.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Psychoeducation for bipolar disorder has a significant impact on symptoms and treatment adherence. In Iran, as a low-resource setting, infrastructural barriers, such as inadequate mental health professionals, difficulties in transportation, and costs of care, may hinder optimum delivery of this evidence-based intervention to patients. Objective: This study sought to explore the acceptability and feasibility of a web-based intervention for bipolar patients in Iran. Methods: A website has been developed as a platform for providing psychoeducational content about bipolar disorder. Patients were chosen via a convenient sampling method in 2018-2019. The main component of the intervention included streaming 7 weekly video clips after attending a single in-person meeting, as well as a medication self-monitoring application. Information was collected about the feasibility and acceptability of the intervention. Results: We invited 45 patients from the day center and the outpatient clinic of Roozbeh psychiatric hospital and some private clinics in Tehran. Of the 23 patients (51%) who attended the first in-person session and provided informed consent, 14 patients dropped out during the study. While 9 patients completed the course (attended 4 or more online sessions), only 5 watched all the video sessions. The rate of adherence to the intervention and frequency of exposure to the website were much higher for those recruited from the private and outpatient clinics. Conclusions: This web-based intervention can be feasible and acceptable only for a subgroup of patients with specific educational status and socioeconomic level. %M 34402794 %R 10.2196/23360 %U https://formative.jmir.org/2021/8/e23360 %U https://doi.org/10.2196/23360 %U http://www.ncbi.nlm.nih.gov/pubmed/34402794 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 8 %P e31061 %T Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial %A Kawai,Yuki %A Sankoda,Akiko %A Waki,Kayo %A Miyake,Kana %A Hayashi,Aki %A Mieno,Makiko %A Wakui,Hiromichi %A Tsurutani,Yuya %A Saito,Jun %A Hirawa,Nobuhito %A Yamakawa,Tadashi %A Komiya,Shiro %A Isogawa,Akihiro %A Satoh,Shinobu %A Minami,Taichi %A Osada,Uru %A Iwamoto,Tamio %A Takano,Tatsuro %A Terauchi,Yasuo %A Tamura,Kouichi %A Yamauchi,Toshimasa %A Kadowaki,Takashi %A Nangaku,Masaomi %A Kashihara,Naoki %A Ohe,Kazuhiko %+ Department of Planning, Information and Management, University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan, 81 3 5800 9129, kwaki-tky@m.u-tokyo.ac.jp %K diabetic kidney disease %K microalbuminuria %K albuminuria %K diabetes mellitus %K self-management support system %K mHealth %K randomized controlled trial %K diabetes %K kidney %K chronic disease %K support %K self-management %K efficacy %K protocol %K therapy %K intervention %K self-care %K behavior %D 2021 %7 17.8.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Diabetic kidney disease (DKD) is one of the main complications of type 2 diabetes mellitus (T2DM). DKD is a known risk factor for end-stage renal disease, cardiovascular disease, and all-cause death. Effective intervention for early-stage DKD is vital to slowing down the progression of kidney disease and improve prognoses. Mobile health (mHealth) is reportedly effective in supporting patients’ self-care and improving glycemic control, but the impact of mHealth on DKD has yet to be shown. Objective: The purpose of this study is to evaluate the efficacy of standard therapy with the addition of a self-management support system, DialBetesPlus, in patients with DKD and microalbuminuria. Methods: This study is a prospective, randomized, open-label, multicenter clinical trial. The target population consists of 160 patients diagnosed with T2DM accompanied by microalbuminuria. We randomly assigned the patients to 2 groups—the intervention group using DialBetesPlus in addition to conventional therapy and the control group using conventional therapy alone. DialBetesPlus is a smartphone application that supports patients’ self-management of T2DM. The study period was 12 months, with a follow-up survey at 18 months. The primary outcome was a change in albuminuria levels at 12 months. Secondary outcomes included changes in physical parameters, blood test results (glycemic control, renal function, and lipid metabolism), lifestyle habits, self-management scores, medication therapy, and quality of life. Results: The study was approved in April 2018. We began recruiting patients in July 2018 and completed recruiting in August 2019. The final 18-month follow-up was conducted in March 2021. We recruited 159 patients and randomly allocated 70 into the intervention group and 61 into the control group, with 28 exclusions due to withdrawal of consent, refusal to continue, or ineligibility. The first results are expected to be available in 2021. Conclusions: This is the first randomized controlled trial assessing the efficacy of mHealth on early-stage DKD. We expect that albuminuria levels will decrease significantly in the intervention group due to improved glycemic control with ameliorated self-care behaviors. Trial Registration: UMIN-CTR UMIN000033261; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000037924 International Registered Report Identifier (IRRID): DERR1-10.2196/31061 %M 34402802 %R 10.2196/31061 %U https://www.researchprotocols.org/2021/8/e31061 %U https://doi.org/10.2196/31061 %U http://www.ncbi.nlm.nih.gov/pubmed/34402802 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 8 %P e23834 %T Efficiency, Usability, and Outcomes of Proctored Next-Level Exams for Proficiency Testing in Primary Care Education: Observational Study %A Schoenmakers,Birgitte %A Wens,Johan %+ Department of Public Health and Primary Care, KU Leuven, Kapucijnenvoer 33/7001, Leuven, 3000, Belgium, 32 495235639, birgitte.schoenmakers@kuleuven.be %K primary care %K education %K graduate %K medical education %K testing %K assessment %K app %K COVID-19 %K efficiency %K accuracy %D 2021 %7 16.8.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: The COVID-19 pandemic has affected education and assessment programs and has resulted in complex planning. Therefore, we organized the proficiency test for admission to the Family Medicine program as a proctored exam. To prevent fraud, we developed a web-based supervisor app for tracking and tracing candidates’ behaviors. Objective: We aimed to assess the efficiency and usability of the proctored exam procedure and to analyze the procedure’s impact on exam scores. Methods: The application operated on the following three levels to register events: the recording of actions, analyses of behavior, and live supervision. Each suspicious event was given a score. To assess efficiency, we logged the technical issues and the interventions. To test usability, we counted the number of suspicious students and behaviors. To analyze the impact that the supervisor app had on students’ exam outcomes, we compared the scores of the proctored group and those of the on-campus group. Candidates were free to register for off-campus participation or on-campus participation. Results: Of the 593 candidates who subscribed to the exam, 472 (79.6%) used the supervisor app and 121 (20.4%) were on campus. The test results of both groups were comparable. We registered 15 technical issues that occurred off campus. Further, 2 candidates experienced a negative impact on their exams due to technical issues. The application detected 22 candidates with a suspicion rating of >1. Suspicion ratings mainly increased due to background noise. All events occurred without fraudulent intent. Conclusions: This pilot observational study demonstrated that a supervisor app that records and registers behavior was able to detect suspicious events without having an impact on exams. Background noise was the most critical event. There was no fraud detected. A supervisor app that registers and records behavior to prevent fraud during exams was efficient and did not affect exam outcomes. In future research, a controlled study design should be used to compare the cost-benefit balance between the complex interventions of the supervisor app and candidates’ awareness of being monitored via a safe browser plug-in for exams. %M 34398786 %R 10.2196/23834 %U https://formative.jmir.org/2021/8/e23834 %U https://doi.org/10.2196/23834 %U http://www.ncbi.nlm.nih.gov/pubmed/34398786 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 8 %P e29529 %T New Internet-Based Warfarin Anticoagulation Management Approach After Mechanical Heart Valve Replacement: Prospective, Multicenter, Randomized Controlled Trial %A Zhu,Zhihui %A Li,Chenyu %A Shen,Jinglun %A Wu,Kaisheng %A Li,Yuehuan %A Liu,Kun %A Zhang,Fan %A Zhang,Zhenhua %A Li,Yan %A Han,Jie %A Qin,Ying %A Yang,Yu %A Fan,Guangpu %A Zhang,Huajun %A Ding,Zheng %A Xu,Dong %A Chen,Yu %A Zheng,Yingli %A Zheng,Zhe %A Meng,Xu %A Zhang,Haibo %+ Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, 2 Anzhen Rd, Beijing, 100029, China, 86 1 337 010 3561, zhanghb2318@163.com %K RCT %K warfarin %K telemedicine %K TTR %K complication %D 2021 %7 13.8.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Mechanical heart valve replacement (MHVR) is an effective method for the treatment of severe heart valve disease; however, it subjects patient to lifelong warfarin therapy after MHVR with the attendant risk of bleeding and thrombosis. Whether internet-based warfarin management reduces complications and improves patient quality of life remains unknown. Objective: This study aimed to compare the effects of internet-based warfarin management and the conventional approach in patients who received MHVR in order to provide evidence regarding alternative strategies for long-term anticoagulation. Methods: This was a prospective, multicenter, randomized, open-label, controlled clinical trial with a 1-year follow-up. Patients who needed long-term warfarin anticoagulation after MHVR were enrolled and then randomly divided into conventional and internet-based management groups. The percentage of time in the therapeutic range (TTR) was used as the primary outcome, while bleeding, thrombosis, and other events were the secondary outcomes. Results: A total of 721 patients were enrolled. The baseline characteristics did not reach statistical differences between the 2 groups, suggesting the random assignment was successful. As a result, the internet-based group showed a significantly higher TTR (mean 0.53, SD 0.24 vs mean 0.46, SD 0.21; P<.001) and fraction of time in the therapeutic range (mean 0.48, SD 0.22 vs mean 0.42, SD 0.19; P<.001) than did those in the conventional group. Furthermore, as expected, the anticoagulation complications, including the bleeding and embolic events had a lower frequency in the internet-based group than in the conventional group (6.94% vs 12.74%; P=.01). Logistic regression showed that internet-based management increased the TTR by 7% (odds ratio [OR] 1.07, 95% CI 1.05-1.09; P<.001) and reduced the bleeding and embolic risk by 6% (OR 0.94, 95% CI 0.92-0.96; P=.01). Moreover, low TTR was found to be a risk factor for bleeding and embolic events (OR 0.87, 95% CI 0.83-0.91; P=.005). Conclusions: The internet-based warfarin management is superior to the conventional method, as it can reduce the anticoagulation complications in patients who receive long-term warfarin anticoagulation after MHVR. Trial Registration: Chinese Clinical Trial Registry ChiCTR1800016204; http://www.chictr.org.cn/showproj.aspx?proj=27518 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2019-032949 %M 34397393 %R 10.2196/29529 %U https://www.jmir.org/2021/8/e29529 %U https://doi.org/10.2196/29529 %U http://www.ncbi.nlm.nih.gov/pubmed/34397393 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 8 %P e24839 %T Effectiveness of Internet-Based Cognitive Behavior Therapy (Fatigue in Teenagers on the Internet) for Adolescents With Chronic Fatigue Syndrome in Routine Clinical Care: Observational Study %A Albers,Eline %A Nijhof,Linde N %A Berkelbach van der Sprenkel,Emma E %A van de Putte,Elise M %A Nijhof,Sanne L %A Knoop,Hans %+ Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute, Meibergdreef 9, Amsterdam, 1105 AZ, Netherlands, 31 20 566 4661, hans.knoop@amsterdamumc.nl %K Fatigue in Teenagers on the Internet %K cognitive behavior therapy %K fatigue %K chronic fatigue syndrome %K adolescents %K implementation %D 2021 %7 13.8.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-based cognitive behavior therapy (I-CBT) for adolescents with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) has been shown to be effective in a randomized controlled trial (RCT; Fatigue in Teenagers on the Internet [FITNET]). FITNET can cause a significant reduction in fatigue and disability. Objective: We aimed to investigate whether FITNET treatment implemented in routine clinical care (IMP-FITNET) was as effective, using the outcomes of the FITNET RCT as the benchmark. Methods: Outcomes of CFS/ME adolescents who started IMP-FITNET between October 2012 and March 2018 as part of routine clinical care were compared to the outcomes in the FITNET RCT. The primary outcome was fatigue severity assessed posttreatment. The secondary outcomes were self-reported physical functioning, school attendance, and recovery rates. Clinically relevant deterioration was assessed posttreatment, and for this outcome, a face-to-face CBT trial was used as the benchmark. The attitude of therapists toward the usability of IMP-FITNET was assessed through semistructured interviews. The number of face-to-face consultations during IMP-FITNET was registered. Results: Of the 384 referred adolescents with CFS/ME, 244 (63.5%) started IMP-FITNET, 84 (21.9%) started face-to-face CBT, and 56 (14.6%) were not eligible for CBT. Posttreatment scores for fatigue severity (mean 26.0, SD 13.8), physical functioning (mean 88.2, SD 15.0), and full school attendance (mean 84.3, SD 26.5) fell within the 95% CIs of the FITNET RCT. Deterioration of fatigue and physical functioning after IMP-FITNET was observed at rates of 1.2% (n=3) and 4.1% (n=10), respectively, which is comparable to a waiting list condition (fatigue: 1.2% vs 5.7%, χ21=3.5, P=.06; physical functioning: 4.1% vs 11.4%, χ21=3.3, P=.07). Moreover, 41 (16.8%) IMP-FITNET patients made use of face-to-face consultations. Conclusions: IMP-FITNET is an effective and safe treatment for adolescents with CFS/ME in routine clinical care. %M 34397389 %R 10.2196/24839 %U https://www.jmir.org/2021/8/e24839 %U https://doi.org/10.2196/24839 %U http://www.ncbi.nlm.nih.gov/pubmed/34397389 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 8 %P e20678 %T Artificial Intelligence–Based Chatbot for Anxiety and Depression in University Students: Pilot Randomized Controlled Trial %A Klos,Maria Carolina %A Escoredo,Milagros %A Joerin,Angela %A Lemos,Viviana Noemí %A Rauws,Michiel %A Bunge,Eduardo L %+ Interdisciplinary Center for Research in Health and Behavioral Sciences (CIICSAC), Universidad Adventista del Plata (UAP)., National Scientific and Technical Research Council (CONICET)., 25 de Mayo 99, Libertador San Martín, Entre Ríos, 3103, Argentina, 54 3435064263, mcarolinaklos@gmail.com %K artificial intelligence %K chatbots %K conversational agents %K mental health %K anxiety %K depression %K college students %D 2021 %7 12.8.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Artificial intelligence–based chatbots are emerging as instruments of psychological intervention; however, no relevant studies have been reported in Latin America. Objective: The objective of the present study was to evaluate the viability, acceptability, and potential impact of using Tess, a chatbot, for examining symptoms of depression and anxiety in university students. Methods: This was a pilot randomized controlled trial. The experimental condition used Tess for 8 weeks, and the control condition was assigned to a psychoeducation book on depression. Comparisons were conducted using Mann-Whitney U and Wilcoxon tests for depressive symptoms, and independent and paired sample t tests to analyze anxiety symptoms. Results: The initial sample consisted of 181 Argentinian college students (158, 87.2% female) aged 18 to 33. Data at week 8 were provided by 39 out of the 99 (39%) participants in the experimental condition and 34 out of the 82 (41%) in the control group. On an average, 472 (SD 249.52) messages were exchanged, with 116 (SD 73.87) of the messages sent from the users in response to Tess. A higher number of messages exchanged with Tess was associated with positive feedback (F2,36=4.37; P=.02). No significant differences between the experimental and control groups were found from the baseline to week 8 for depressive and anxiety symptoms. However, significant intragroup differences demonstrated that the experimental group showed a significant decrease in anxiety symptoms; no such differences were observed for the control group. Further, no significant intragroup differences were found for depressive symptoms. Conclusions: The students spent a considerable amount of time exchanging messages with Tess and positive feedback was associated with a higher number of messages exchanged. The initial results show promising evidence for the usability and acceptability of Tess in the Argentinian population. Research on chatbots is still in its initial stages and further research is needed. %M 34092548 %R 10.2196/20678 %U https://formative.jmir.org/2021/8/e20678 %U https://doi.org/10.2196/20678 %U http://www.ncbi.nlm.nih.gov/pubmed/34092548 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 8 %P e29026 %T Evaluation of a Digital Health Initiative in Illicit Substance Use: Cross-sectional Survey Study %A Kershaw,Steph %A Birrell,Louise %A Deen,Hannah %A Newton,Nicola C %A Stapinski,Lexine A %A Champion,Katrina E %A Kay-Lambkin,Frances %A Teesson,Maree %A Chapman,Cath %+ The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Level 6, Jane Foss Russell building, Camperdown, Sydney, 2006, Australia, 61 2 8627 9018, steph.kershaw@sydney.edu.au %K methamphetamine %K eHealth %K substance-related disorders %K internet %K preventive psychiatry %K health education %K mobile phone %D 2021 %7 10.8.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The Cracks in the Ice (CITI) community toolkit was developed to provide evidence-based, up-to-date information and resources about crystal methamphetamine to Australians. Given the high rates of internet use in the community and the potential for misinformation, CITI has the potential to play an important role in improving knowledge and challenging misconceptions surrounding crystal methamphetamine. Objective: This study aims to determine (1) whether the CITI toolkit is achieving its aim of disseminating evidence-based information and resources to people who use crystal methamphetamine, their family and friends, health professionals, and the general community and (2) examine the association between the use of CITI and the knowledge and attitudes about crystal methamphetamine. Methods: A cross-sectional web-based survey, open to Australian residents (aged ≥18 years), was conducted from November 2018 to March 2019. People who had previously visited the website (referred to as “website visitors” in this study) and those who had not (“naïve”) were recruited. At baseline, knowledge, attitudes, and demographics were assessed. CITI website visitors then completed a series of site evaluation questions, including the System Usability Scale (SUS), and naïve participants were asked to undertake a guided site tour of a replicated version of the site before completing the evaluation questions and repeating knowledge and attitude scales. Results: Of a total 2108 participants, 564 (26.7%) reported lifetime use of crystal methamphetamine, 434 (20.6%) were family/friends, 288 (13.7%) were health professionals, and 822 (38.9%) were community members. The average SUS score was 73.49 (SD 13.30), indicating good site usability. Health professionals reported significantly higher SUS scores than community members (P=.02) and people who used crystal methamphetamine (P<.001). Website visitors had significantly higher baseline knowledge than naïve participants (P<.001). Among naïve participants, knowledge scores increased following exposure to the website (mean 15.2, SE 0.05) compared to baseline (mean 14.4, SE 0.05; P<.001). The largest shifts in knowledge were observed for items related to prevalence, legal issues, and the effects of the drug. Stigmatizing attitude scores among the naïve group were significantly lower following exposure to CITI (mean 41.97, SE 0.21) compared to baseline (mean 44.3, SE 0.21; P<.001). Conclusions: This study provides an innovative evaluation of a national eHealth resource. CITI is achieving its aim of disseminating evidence-based, nonstigmatizing, and useful information and resources about crystal methamphetamine to key end user groups and has received good usability scores across its target groups. Interaction with CITI led to immediate improvements in knowledge about crystal methamphetamine and a decrease in stigmatizing attitudes. CITI demonstrates the important role of digital information and support platforms for translating evidence into practice and improving knowledge and reducing stigma. %M 34383690 %R 10.2196/29026 %U https://www.jmir.org/2021/8/e29026 %U https://doi.org/10.2196/29026 %U http://www.ncbi.nlm.nih.gov/pubmed/34383690 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 8 %N 3 %P e27452 %T Designing Consumer Health Information Technology to Support Biform and Articulation Work: A Qualitative Study of Diet and Nutrition Management as Patient Work %A Rogers,Courtney C %A Moutinho Jr,Thomas J %A Liu,Xiaoyue %A Valdez,Rupa S %+ Department of Public Health Sciences, University of Virginia, PO Box 800717, Hospital West Complex, Charlottesville, VA, 22908, United States, 1 434 982 2510, rsv9d@virginia.edu %K Crohn disease %K inflammatory bowel diseases %K chronic disease %K self-management %K consumer health information technology %K qualitative research %K user-centered design %K patient work %K context %K articulation work %K diet %K nutrition %D 2021 %7 10.8.2021 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Diet and nutrition management is an integral component of Crohn disease (CD) management. This type of management is highly variable and individualized and, thus, requires personalized approaches. Consumer health information technology (CHIT) designed to support CD management has typically supported this task as everyday life work and, not necessarily, as illness work. Moreover, CHIT has rarely supported the ways in which diet and nutrition management requires coordination between multiple forms of patient work. Objective: The purpose of this study was to investigate diet and nutrition management as biform work, identify components of articulation work, and provide guidance on how to design CHIT to support this work. Methods: We performed a qualitative study in which we recruited participants from CD-related Facebook pages and groups. Results: Semistructured interviews with 21 individuals showed that diet and nutrition management strategies were highly individualized and variable. Four themes emerged from the data, emphasizing the interactions of diet and nutrition with physical, emotional, information, and technology-enabled management. Conclusions: This study shows that the extent to which diet and nutrition management is biform work fluctuates over time and that articulation work can be continuous and unplanned. The design guidance specifies the need for patient-facing technologies to support interactions among diet and nutrition and other management activities such as medication intake, stress reduction, and information seeking, as well as to respond to the ways in which diet and nutrition management needs change over time. %M 34383664 %R 10.2196/27452 %U https://humanfactors.jmir.org/2021/3/e27452 %U https://doi.org/10.2196/27452 %U http://www.ncbi.nlm.nih.gov/pubmed/34383664 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 8 %P e28855 %T Design of the Maternal Website EMAeHealth That Supports Decision-Making During Pregnancy and in the Postpartum Period: Collaborative Action Research Study %A Artieta-Pinedo,Isabel %A Paz-Pascual,Carmen %A Bully,Paola %A Espinosa,Maite %A , %+ Osakidetza-Basque Health Service, Biocruces-Bizkaia Health Research Institute, Osi Barakaldo-Sestao, Lurkizaga S/N, Barakaldo, 48901, Spain, 34 946006667, misabel.artieta@ehu.eus %K prenatal education %K women %K patient decision aid %K decision-making %K clinical decision support systems %K action research and pregnancy %K implementation science %K health service needs and demands %D 2021 %7 9.8.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Despite the benefit maternal education has for women, it needs new tools to increase its effectiveness and scope, in tune with the needs of current users. Objective: We attempted to develop a multifunctional personalized eHealth platform aimed at the self-management of health in relation to maternity, which can be considered a flexible and adaptable maternal education tool. Methods: The International Patient Decision Aid Standards (IPDAS) were applied. A website prototype was developed for implementation in the public health system using a collaborative action research process, in which experts and patients participate, with qualitative research techniques, as well as focus groups, prioritization, and consensus techniques. Results: We have proposed a website that includes (1) systematically updated information related to clinical practice guidelines, (2) interaction between peers and users/professionals, (3) instruments for self-assessment of health needs as a basis for working on counseling, agreement on actions, help in the search for resources, support in decision-making, and monitoring and evaluation of results, and (4) access for women to their clinical data and the option of sharing the data with other health agents. These components, with different access requirements, would be reviewed through iterative cycles depending on the frequency and effectiveness resulting from their use and would be accessible from any digital device. Conclusions: A website that supports maternal education should contain not only information, but also resources for individual attention and social support. Its usefulness for the health and satisfaction of women should be evaluated in various different environments. %M 34383670 %R 10.2196/28855 %U https://formative.jmir.org/2021/8/e28855 %U https://doi.org/10.2196/28855 %U http://www.ncbi.nlm.nih.gov/pubmed/34383670 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 8 %P e25389 %T Web-Based Guidance Through Assisted Reproductive Technology (myFertiCare): Patient-Centered App Development and Qualitative Evaluation %A Sparidaens,Ellen Marie %A Hermens,Rosella P M %A Braat,Didi D M %A Nelen,Willianne L D M %A Fleischer,Kathrin %+ Department of Obstetrics and Gynaecology, Radboud University Medical Center, PO Box 9101, Nijmegen, 6500HB, Netherlands, 31 (0)243617351, ellenmarie.sparidaens@radboudumc.nl %K eHealth %K infertility %K interactive %K mobile apps %K patient education %K patient-centered care %K personalized %K topic %D 2021 %7 3.8.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Providing patient-centered fertility care is known to improve quality of life and can reduce anxiety and depression. In a previous study, we established the need for a web-based app providing personalized information and interactive functionalities among couples undergoing intracytoplasmic sperm injection with surgically retrieved sperm. Objective: This study aimed to design, develop, and qualitatively evaluate a multifaceted web-based app for infertile couples undergoing intracytoplasmic sperm injection with surgically retrieved sperm during their treatment trajectory. Methods: The web-based app was developed in three phases: (1) we established a patient-centered functional design, (2) developed the app in collaboration with medical and technical professionals, and (3) qualitatively evaluated the app among couples using a think-aloud method. Results: The basis of the app is the couple’s visualized treatment trajectory. The app provides personalized and interactive functionalities; for example, customized information and communication options. During qualitative evaluation, myFertiCare was highly appreciated and received a median score of 8 out of 10. The main improvements made upon conclusion of the think-aloud sessions were related to faster login and easier app navigation. Conclusions: A patient-centered web-based app aimed at guiding couples through their fertility treatment course was systematically designed, developed, and positively evaluated by patients and medical and technical professionals. %M 34342591 %R 10.2196/25389 %U https://www.jmir.org/2021/8/e25389 %U https://doi.org/10.2196/25389 %U http://www.ncbi.nlm.nih.gov/pubmed/34342591 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e30709 %T Online-Delivered Group and Personal Exercise Programs to Support Low Active Older Adults’ Mental Health During the COVID-19 Pandemic: Randomized Controlled Trial %A Beauchamp,Mark R %A Hulteen,Ryan M %A Ruissen,Geralyn R %A Liu,Yan %A Rhodes,Ryan E %A Wierts,Colin M %A Waldhauser,Katrina J %A Harden,Samantha H %A Puterman,Eli %+ School of Kinesiology, University of British Columbia, 6081 University Blvd, Vancouver, BC, V6T 1Z1, Canada, 1 604 822 4864, mark.beauchamp@ubc.ca %K COVID-19 %K randomized trial %K mental health %K physical activity %D 2021 %7 30.7.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: In response to the COVID-19 pandemic, experts in mental health science emphasized the importance of developing and evaluating approaches to support and maintain the mental health of older adults. Objective: The aim of this study was to assess whether a group-based exercise program relative to a personal exercise program (both delivered online) and waitlist control (WLC) can improve the psychological health of previously low active older adults during the early stages of the COVID-19 pandemic. Methods: The Seniors COVID-19 Pandemic and Exercise (SCOPE) trial was a 3-arm, parallel randomized controlled trial conducted between May and September 2020 in which low active older adults (aged ≥65 years) were recruited via media outlets and social media. After baseline assessments, consented participants were randomized to one of two 12-week exercise programs (delivered online by older adult instructors) or a WLC condition. A total of 241 older adults (n=187 women) provided baseline measures (via online questionnaires), were randomized (ngroup=80, npersonal=82, ncontrol=79), and completed measures every 2 weeks for the duration of the trial. The trial’s primary outcome was psychological flourishing. Secondary outcomes included global measures of mental and physical health, life satisfaction, and depression symptoms. Results: The results of latent growth modeling revealed no intervention effects for flourishing, life satisfaction, or depression symptoms (P>.05 for all). Participants in the group condition displayed improved mental health relative to WLC participants over the first 10 weeks (effect size [ES]=0.288-0.601), and although the week 12 effect (ES=0.375) was in the same direction the difference was not statistically significant (P=.089). Participants in the personal condition displayed improved mental health, when compared with WLC participants, in the same medium ES range (ES=0.293-0.565) over the first 8 weeks, and while the effects were of a similar magnitude at weeks 10 (ES=0.455, P=.069) and 12 (ES=0.258, P=.353), they were not statistically significant. In addition, participants in the group condition displayed improvements in physical health when compared with the WLC (ES=0.079-0.496) across all 12 weeks of the study following baseline. No differences were observed between the personal exercise condition and WLC for physical health (slope P=.271). Conclusions: There were no intervention effects for the trial’s primary outcome (ie, psychological flourishing). It is possible that the high levels of psychological flourishing at baseline may have limited the extent to which those indicators could continue to improve further through intervention (ie, potential ceiling effects). However, the intervention effects for mental and physical health point to the potential capacity of low-cost and scalable at-home programs to support the mental and physical health of previously inactive adults in the COVID-19 pandemic. Trial Registration: ClinicalTrials.gov NCT04412343; https://clinicaltrials.gov/ct2/show/NCT04412343 %M 34328433 %R 10.2196/30709 %U https://www.jmir.org/2021/7/e30709 %U https://doi.org/10.2196/30709 %U http://www.ncbi.nlm.nih.gov/pubmed/34328433 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e27861 %T Supporting Patient-Clinician Interaction in Chronic HIV Care: Design and Development of a Patient-Reported Outcomes Software Application %A Herrmann,Susan %A Power,Brad %A Rashidi,Amineh %A Cypher,Mark %A Mastaglia,Frank %A Grace,Amy %A McKinnon,Elizabeth %A Sarrot,Pierre %A Michau,Christophe %A Skinner,Matthew %A Desai,Renae %A Duracinsky,Martin %+ Medical School, University of Western Australia, 35 Stirling Hwy, Crawley, 6009, Australia, 61 0417997934, Susan.Herrmann@uwa.edu.au %K physician-patient communication %K eHealth %K primary care %K ambulatory care %K information systems %K user-centered design %K user context %K patient reported outcomes %K qualitative research %K health care %K HIV care %K mobile phone %D 2021 %7 30.7.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The consideration of health-related quality of life (HRQL) is a hallmark of best practice in HIV care. Information technology offers an opportunity to more closely engage patients with chronic HIV infection in their long-term management and support a focus on HRQL. However, the implementation of patient-reported outcome (PRO) measures, such as HRQL in routine care, is challenged by the need to synthesize data generated by questionnaires, the complexity of collecting data between patient visits, and the integration of results into clinical decision-making processes. Objective: Our aim is to design and pilot-test a multimedia software platform to overcome these challenges and provide a vehicle to increase focus on HRQL issues in HIV management. Methods: A multidisciplinary team in France and Australia conducted the study with 120 patients and 16 doctors contributing to the design and development of the software. We used agile development principles, user-centered design, and qualitative research methods to develop and pilot the software platform. We developed a prototype application to determine the acceptability of the software and piloted the final version with 41 Australian and 19 French residents using 2 validated electronic questionnaires, the Depression, Anxiety and Stress Scale-21 Items, and the Patient Reported Outcomes Quality of Life-HIV. Results: Testing of the prototype demonstrated that patients wanted an application that was intuitive and without excessive instruction, so it felt effortless to use, as well as secure and discreet. Clinicians wanted the PRO data synthesized, presented clearly and succinctly, and clinically actionable. Safety concerns for patients and clinicians included confidentiality, and the potential for breakdown in communication if insufficient user training was not provided. The final product, piloted with patients from both countries, showed that most respondents found the application easy to use and comprehend. The usability testing survey administered found that older Australians had reduced scores for understanding the visual interface (P=.004) and finding the buttons organized (P=.02). Three-fourths of the respondents were concerned with confidentiality (P=.007), and this result was more prevalent in participants with higher anxiety and stress scores (P=.01), as measured by the Depression, Anxiety and Stress Scale-21 Items. These statistical associations were not observed in 15 French patients who completed the same questionnaire. Conclusions: Digital applications in health care should be safe and fit for purpose. Our software was acceptable to patients and shows potential to overcome some barriers to the implementation of PROs in routine care. The design of the clinicians’ interface presents a solution to the problem of voluminous data, both synthesizing and providing a snapshot of longitudinal data. The next stage is to conduct a randomized controlled trial to determine whether patients experience increased satisfaction with care and whether doctors perceive that they deliver better clinical care without compromising efficiency. %M 34328442 %R 10.2196/27861 %U https://www.jmir.org/2021/7/e27861 %U https://doi.org/10.2196/27861 %U http://www.ncbi.nlm.nih.gov/pubmed/34328442 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 7 %P e30241 %T An Avatar-Led Digital Smoking Cessation Program for Sexual and Gender Minority Young Adults: Intervention Development and Results of a Single-Arm Pilot Trial %A Heffner,Jaimee L %A Watson,Noreen L %A Serfozo,Edit %A Kelly,Megan M %A Reilly,Erin D %A Kim,Daniella %A Baker,Kelsey %A Scout,N F N %A Karekla,Maria %+ Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, M3-B232, Seattle, WA, 98109, United States, 1 2066677314, jheffner@fredhutch.org %K LGBT %K embodied agent %K tobacco cessation %K nicotine dependence %K user-centered design %K avatar %K digital health %K minority %K young adult %K teenager %K smoking %K cessation %K intervention %K development %K pilot trial %D 2021 %7 30.7.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Sexual and gender minority young adults have a high prevalence of smoking and unique barriers to accessing tobacco treatment. Objective: To address these challenges as well as their preferences for sexual and gender minority–targeted interventions and digital programs, we developed and evaluated the acceptability, preliminary efficacy, and impact on theory-based change processes of an acceptance and commitment therapy–based digital program called Empowered, Queer, Quitting, and Living (EQQUAL). Methods: Participants (n=22) of a single-arm trial conducted to evaluate the program were young adults, age 18 to 30 years, who self-identified as sexual and gender minority individuals and smoked at least one cigarette per day. All participants received access to the EQQUAL program. Participants completed web-based surveys at baseline and at a follow-up 2 months after enrollment. We verified self-reported smoking abstinence with biochemical testing; missing data were counted as smoking or using tobacco. Results: For young adults who logged in at least once (n=18), the mean number of log-ins was 5.5 (SD 3.6), mean number of sessions completed was 3.1 (SD 2.6), and 39% (7/18) completed all 6 sessions. Overall, 93% of participants (14/15) were satisfied with the EQQUAL program, 100% (15/15) found it easy to use, and 100% (15/15) said it helped them be clearer about how to quit. Abstinence from smoking or using tobacco was confirmed with biochemical testing for 23% of participants (5/22). Both quantitative and qualitative results suggested a positive overall response to the avatar guide, with areas for future improvement largely centered on the avatar’s appearance and movements. Conclusions: Treatment acceptability of EQQUAL was very promising. The rate of abstinence, which was biochemically confirmed, was 3 times higher than that of the only other digital program to date that has targeted sexual and gender minority young adults and 6 to 13 times higher than those of nontargeted digital smoking interventions among sexual and gender minority young adults. Planned improvements for the next iteration of the program include making the avatar’s movements more natural; offering multiple avatar guides with different on characteristics such as race, ethnicity, and gender identity from which to choose; and providing a support forum for users to connect anonymously with peers. %M 34328430 %R 10.2196/30241 %U https://formative.jmir.org/2021/7/e30241 %U https://doi.org/10.2196/30241 %U http://www.ncbi.nlm.nih.gov/pubmed/34328430 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e26376 %T App-Tailoring Requirements to Increase Stress Management Competencies Within Families: Cross-sectional Survey Study %A Bischoff,Laura Luise %A Baumann,Hannes %A Meixner,Charlotte %A Nixon,Patricia %A Wollesen,Bettina %+ Department of Movement Science, Faculty of Psychology and Human Movement, University of Hamburg, Mollerstraße 10, Hamburg, 20148, Germany, 49 40 42838 93, laura.bischoff@uni-hamburg.de %K mhealth %K ehealth %K mobile applications %K stress management %K app features %K gamification %K family %K personality traits %D 2021 %7 30.7.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Families experiencing high levels of psychological distress are considered a particularly vulnerable population for adverse effects on mental and physical health. Moreover, highly stressed individuals engage less in mental health promoting activities and show low stress management competencies. App-based stress interventions seem promising for the treatment and prevention of stress outcomes and might be a low-threshold solution. Objective: The aim of this study was to identify the requirements for a tailored app to reduce stress in a cohort of highly stressed families that have low stress management skills. Methods: Parents (n=1008; age: mean 47.7 years, SD 6.1; female: 599/1008, 59.7%) completed an extensive web-based survey and were subdivided into a target (stressed individuals with low stress competency) and nontarget group according to their reported stress level and stress management competencies. Group differences were analyzed using analysis of variance. In principal component analysis with Kaiser varimax rotation, personally defined stress management goals were grouped into components. Linear regression models were also calculated. Results: A 3-factor solution cumulatively explained 56% of the variance in personally defined goals of interest for stress management with (1) active strategies (25.61% explained variance), (2) general competency (17.95% explained variance) and (3) passive strategies (12.45% explained variance). The groups differed in age (F1,978=27.67, P<.001), health index (F1,958=246.14, P<.001), personally defined general-competency goal (F1,958=94.16 P<.001), as well as “information acquisition” (F1,971=14.75, P<.001) and “need for stimulation” (F1,981=54.49, P<.001) personality traits. A regression model showed that for the active strategies goals of interest, only app feature information or instructional videos had a significant effect (P=.02). The general competency factor showed none, and the passive strategies factor showed significant effects for 2 app features—suggestions for planning possible activities with the family (P=.01) and diaries for documentation and development of strategies (P=.03). Conclusions: The results of this survey study highlight the need to develop an app to increase stress management competencies that takes into consideration perceived stress level, stress management skills, personality, and personally defined goals of the user. The content of the app should be tailored to previously detected personality traits, especially selective information acquisition and low need for stimulation. Furthermore, personally defined stress management goals seem to affect interest in some features. %M 34328439 %R 10.2196/26376 %U https://www.jmir.org/2021/7/e26376 %U https://doi.org/10.2196/26376 %U http://www.ncbi.nlm.nih.gov/pubmed/34328439 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e26235 %T Older Adults’ Experiences of Behavior Change Support in a Digital Fall Prevention Exercise Program: Qualitative Study Framed by the Self-determination Theory %A Pettersson,Beatrice %A Janols,Rebecka %A Wiklund,Maria %A Lundin-Olsson,Lillemor %A Sandlund,Marlene %+ Physiotherapy, Department of Community Medicine and Rehabilitation, Umeå University, Umeå, 90187, Sweden, 46 907865224, beatrice.pettersson@umu.se %K accidental falls %K aged %K exercise %K qualitative research %K eHealth %K self-management %K fall prevention %K behavior change %K self-determination theory %K classification of motivation and behavior change techniques %D 2021 %7 30.7.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Exercise is an effective intervention to prevent falls in older adults; however, long-term adherence is often poor. To increase adherence, additional support for behavior change has been advocated. However, consistency in the reporting of interventions using behavior change techniques is lacking. Recently, a classification system has been developed to increase consistency in studies using behavior change techniques within the self-determination theory. Objective: This study aimed to explore expressions of self-determination among community-dwelling older adults using a self-managed digital fall prevention exercise program comprising behavior change support (the Safe Step program), which was developed in co-creation with intended users. Methods: The qualitative study design was based on open-ended responses to questionnaires, and individual and focus group interviews. A deductive qualitative content analysis was applied using the classification system of motivation and behavior change techniques as an analytical matrix, followed by an inductive analysis. Twenty-five participants took part in a feasibility study and exercised in their homes with the Safe Step program for 4 months. The exercise program was available on computers, smartphones, and tablets, and was fully self-managed. Results: In the deductive analysis, expressions of support were demonstrated for all three basic human psychological needs, namely, autonomy, competence, and relatedness. These expressions were related to 11 of the 21 motivation and behavior change techniques in the classification system. The inductive analysis indicated that autonomy (to be in control) was valued and enabled individual adaptations according to different rationales for realizing exercise goals. However, the experience of autonomy was also two-sided and depended on the participants’ competence in exercise and the use of technology. The clarity of the program and exercise videos was seen as key for support in performance and competent choices. Although augmented techniques for social support were requested, support through relatedness was found within the program. Conclusions: In this study, the Safe Step program supported the establishment of new exercise routines, as well as the three basic human psychological needs, with autonomy and competence being expressed as central in this context. Based on the participants’ experiences, a proposed addition to the classification system used as an analytical matrix has been presented. Trial Registration: ClinicalTrials.gov NCT02916849; https://clinicaltrials.gov/ct2/show/NCT02916849 %M 34328438 %R 10.2196/26235 %U https://www.jmir.org/2021/7/e26235 %U https://doi.org/10.2196/26235 %U http://www.ncbi.nlm.nih.gov/pubmed/34328438 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e21202 %T Preadolescent Students’ Engagement With an mHealth Intervention Fostering Social Comparison for Health Behavior Change: Crossover Experimental Study %A Nuijten,Raoul Ceasar Yannic %A Van Gorp,Pieter %A Borghouts,Tom %A Le Blanc,Pascale %A Van den Berg,Pauline %A Kemperman,Astrid %A Hadian,Ehsan %A Simons,Monique %+ Department of Industrial Engineering, Eindhoven University of Technology, Groene Loper 3, Eindhoven, 5612 AE, Netherlands, 31 0614906142, r.c.y.nuijten@tue.nl %K mHealth %K health promotion %K social comparison %K competitiveness %K collaboration %K gamification %K preadolescents %K high school students %D 2021 %7 29.7.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Contemporary mobile health (mHealth) interventions use various behavior change techniques to promote healthier lifestyles. Social comparison is one of the techniques that is consensually agreed to be effective in engaging the general population in mHealth interventions. However, it is unclear how this strategy can be best used to engage preadolescents. Nevertheless, this strategy has great potential for this target audience, as they are particularly developing their social skills. Objective: This study aims to evaluate how social comparison drives preadolescents’ engagement with an mHealth app. Methods: We designed a 12-week crossover experiment in which we studied 3 approaches to implementing behavior change via social comparison. This study was hosted in a school environment to leverage naturally existing social structures among preadolescents. During the experiment, students and teachers used an mHealth tool that awarded points for performing healthy activities. Participants could read their aggregated scores on a leaderboard and compare their performance with others. In particular, these leaderboards were tweaked to implement 3 approaches of the social comparison technique. The first approach focused on intragroup comparison (ie, students and teachers competing against each other to obtain the most points), whereas the other two approaches focused on intergroup comparison (ie, classes of students and their mentoring teachers collaborating to compete against other classes). Additionally, in the third approach, the performance of teachers was highlighted to further increase students’ engagement through teachers’ natural exemplary function. To obtain our results, we used linear modeling techniques to analyze the dropout rates and engagement levels for the different approaches. In such analyses, we also considered individual participant traits. Results: Our sample included 313 participants—290 students (92.7%) and 23 teachers (7.3%). It was found that student engagement levels dropped over time and declined during holidays. However, students seemed to monitor the intergroup competitions more closely than the intragroup competitions, as they, on average, checked the mHealth app more often when they were engaged in team-based comparisons. Students, on average, performed the most unique activities when they were engaged in the second intergroup setting, perhaps because their teachers were most active in this setting. Moreover, teachers seemed to play an important role in engaging their students, as their relationship with their students influenced the engagement of the students. Conclusions: When using social comparison to engage preadolescents with an mHealth tool, an intergroup setting, rather than an intragroup competition, motivated them to engage with the app but did not necessarily motivate them to perform more activities. It seems that the number of unique activities that preadolescents perform depends on the activeness of a role model. Moreover, this effect is amplified by preadolescents’ perceptions of closeness to that role model. %M 34326041 %R 10.2196/21202 %U https://www.jmir.org/2021/7/e21202 %U https://doi.org/10.2196/21202 %U http://www.ncbi.nlm.nih.gov/pubmed/34326041 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e25973 %T Turn on, Tune in, and Drop out: Predictors of Attrition in a Prospective Observational Cohort Study on Psychedelic Use %A Hübner,Sebastian %A Haijen,Eline %A Kaelen,Mendel %A Carhart-Harris,Robin Lester %A Kettner,Hannes %+ Centre for Psychedelic Research, Imperial College London, Du Cane Rd, Burlington Danes Building, London, W12 0TY, United Kingdom, 44 020 7589 5111, hannes.kettner17@imperial.ac.uk %K attrition %K digital data %K dropout %K educational level %K personality %K psychedelics %K web-based research %K web-based survey %D 2021 %7 28.7.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The resurgence of research and public interest in the positive psychological effects of psychedelics, together with advancements in digital data collection techniques, have brought forth a new type of research design, which involves prospectively gathering large-scale naturalistic data from psychedelic users; that is, before and after the use of a psychedelic compound. A methodological limitation of such studies is their high attrition rate, particularly owing to participants who stop responding after initial study enrollment. Importantly, study dropout can introduce systematic biases that may affect the interpretability of results. Objective: Based on a previously collected sample (baseline n=654), here we investigated potential determinants of study attrition in web-based prospective studies on psychedelic use. Methods: Logistic regression models were used to examine demographic, psychological trait and state, and psychedelic-specific predictors of dropout. Predictors were assessed 1 week before, 1 day after, and 2 weeks after psychedelic use, with attrition being defined as noncompletion of the key endpoint 4 weeks post experience. Results: Predictors of attrition were found among demographic variables including age (β=0.024; P=.007) and educational levels, as well as personality traits, specifically conscientiousness (β=–0.079; P=.02) and extraversion (β=0.082; P=.01). Contrary to prior hypotheses, neither baseline attitudes toward psychedelics nor the intensity of acute challenging experiences were predictive of dropout. Conclusions: The baseline predictors of attrition identified here are consistent with those reported in longitudinal studies in other scientific disciplines, suggesting their transdisciplinary relevance. Moreover, the lack of an association between attrition and psychedelic advocacy or negative drug experiences in our sample contextualizes concerns about problematic biases in these and related data. %M 34319246 %R 10.2196/25973 %U https://www.jmir.org/2021/7/e25973 %U https://doi.org/10.2196/25973 %U http://www.ncbi.nlm.nih.gov/pubmed/34319246 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 7 %N 3 %P e28370 %T Usability, Acceptability, and Safety Analysis of a Computer-Tailored Web-Based Exercise Intervention (ExerciseGuide) for Individuals With Metastatic Prostate Cancer: Multi-Methods Laboratory-Based Study %A Evans,Holly EL %A Forbes,Cynthia C %A Galvão,Daniel A %A Vandelanotte,Corneel %A Newton,Robert U %A Wittert,Gary %A Chambers,Suzanne %A Vincent,Andrew D %A Kichenadasse,Ganessan %A Girard,Danielle %A Brook,Nicholas %A Short,Camille E %+ Freemasons Centre for Male Health & Wellbeing, School of Medicine, University of Adelaide, Level 7, South Australian Health & Medical Research Institute, North Terrace, Adelaide, 5000, Australia, 61 8 8128 4043, holly.evans@adelaide.edu.au %K exercise %K metastatic prostate cancer %K behavioral change %K eHealth %K computer-tailoring %K usability %K acceptability %D 2021 %7 28.7.2021 %9 Original Paper %J JMIR Cancer %G English %X Background: Digital health interventions such as tailored websites are emerging as valuable tools to provide individualized exercise and behavioral change information for individuals diagnosed with cancer. Objective: The aim of this study is to investigate and iteratively refine the acceptability and usability of a web-based exercise intervention (ExerciseGuide) for men with metastatic prostate cancer and determine how well individuals can replicate the video-based exercise prescription. Methods: A laboratory-based multi-methods design was used, incorporating questionnaires, think-aloud tests, interviews, and movement screening among 11 men aged 63 to 82 years with metastatic prostate cancer. Overall, 9 participants were undergoing androgen deprivation therapy, and 2 were completing chemotherapy. Data were collected in two waves, with changes made for quality improvement after participant 5. Results: The intervention’s usability score was deemed moderate overall but improved after modifications (from 60, SD 2.9 to 69.6, SD 2.2 out of 100). Overall, the participants found the intervention acceptable, with scores improving from wave 1 (24.2, SD 1.1 out of 30) to wave 2 (26.3, SD 2.1 out of 30). The personalized multimodal exercise prescription and computer-tailored education were seen as valuable. After wave 1, website navigation videos were added, medical terminology was simplified, and a telehealth component was included after expert real-time telehealth support was requested. Wave 2 changes included the added variety for aerobic exercise modes, reduced computer-tailoring question loads, and improved consistency of style and grammar. Finally, the participants could replicate the resistance exercise videos to a satisfactory level as judged by the movement screen; however, additional technique cueing within the videos is recommended to address safety concerns. Conclusions: The acceptability and usability of ExerciseGuide were deemed satisfactory. Various problems were identified and resolved. Notably, the participants requested the inclusion of personalized expert support through telehealth. The resistance training algorithms were shown to provide appropriate content safely, and the users could replicate the exercise technique unaided to a satisfactory level. This study has optimized the ExerciseGuide intervention for further investigation in this population. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618001978257; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001978257 %M 34318759 %R 10.2196/28370 %U https://cancer.jmir.org/2021/3/e28370 %U https://doi.org/10.2196/28370 %U http://www.ncbi.nlm.nih.gov/pubmed/34318759 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 7 %N 7 %P e29060 %T The Effect of a Wordless, Animated, Social Media Video Intervention on COVID-19 Prevention: Online Randomized Controlled Trial %A Vandormael,Alain %A Adam,Maya %A Greuel,Merlin %A Gates,Jennifer %A Favaretti,Caterina %A Hachaturyan,Violetta %A Bärnighausen,Till %+ Heidelberg Institute of Global Health, Heidelberg University, 130.3 Im Neuenheimer Feld, Heidelberg, 69120, Germany, 49 163 481 3452, alain.vandormael@uni-heidelberg.de %K social media %K cultural and social implications %K randomized controlled trial %K list experiment %K information literacy %K COVID-19 %K pandemic %K digital health %K infodemiology %K global health %K public health %D 2021 %7 27.7.2021 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: Innovative approaches to the dissemination of evidence-based COVID-19 health messages are urgently needed to counter social media misinformation about the pandemic. To this end, we designed a short, wordless, animated global health communication video (the CoVideo), which was rapidly distributed through social media channels to an international audience. Objective: The objectives of this study were to (1) establish the CoVideo’s effectiveness in improving COVID-19 prevention knowledge, and (2) establish the CoVideo’s effectiveness in increasing behavioral intent toward COVID-19 prevention. Methods: In May and June 2020, we enrolled 15,163 online participants from the United States, Mexico, the United Kingdom, Germany, and Spain. We randomized participants to (1) the CoVideo arm, (2) an attention placebo control (APC) arm, and (3) a do-nothing arm, and presented 18 knowledge questions about preventive COVID-19 behaviors, which was our first primary endpoint. To measure behavioral intent, our second primary endpoint, we randomized participants in each arm to five list experiments. Results: Globally, the video intervention was viewed 1.2 million times within the first 10 days of its release and more than 15 million times within the first 4 months. Knowledge in the CoVideo arm was significantly higher (mean 16.95, 95% CI 16.91-16.99) than in the do-nothing (mean 16.86, 95% CI 16.83-16.90; P<.001) arm. We observed high baseline levels of behavioral intent to perform many of the preventive behaviors featured in the video intervention. We were only able to detect a statistically significant impact of the CoVideo on one of the five preventive behaviors. Conclusions: Despite high baseline levels, the intervention was effective at boosting knowledge of COVID-19 prevention. We were only able to capture a measurable change in behavioral intent toward one of the five COVID-19 preventive behaviors examined in this study. The global reach of this health communication intervention and the high voluntary engagement of trial participants highlight several innovative features that could inform the design and dissemination of public health messages. Short, wordless, animated videos, distributed by health authorities via social media, may be an effective pathway for rapid global health communication during health crises. Trial Registration: German Clinical Trials Register DRKS00021582; https://tinyurl.com/6r4zkbbn International Registered Report Identifier (IRRID): RR2-10.1186/s13063-020-04942-7 %M 34174778 %R 10.2196/29060 %U https://publichealth.jmir.org/2021/7/e29060 %U https://doi.org/10.2196/29060 %U http://www.ncbi.nlm.nih.gov/pubmed/34174778 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e23029 %T A Brief Intervention to Increase Uptake and Adherence of an Internet-Based Program for Depression and Anxiety (Enhancing Engagement With Psychosocial Interventions): Randomized Controlled Trial %A Batterham,Philip J %A Calear,Alison L %A Sunderland,Matthew %A Kay-Lambkin,Frances %A Farrer,Louise M %A Christensen,Helen %A Gulliver,Amelia %+ Centre for Mental Health Research, Research School of Population Health, The Australian National University, 63 Eggleston Rd, Acton, Canberra, 2601, Australia, 61 02612 ext 51031, philip.batterham@anu.edu.au %K implementation %K mental health %K adherence %K uptake %K engagement-facilitation intervention %K internet %K randomized controlled trial %D 2021 %7 27.7.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Psychosocial, self-guided, internet-based programs are effective in treating depression and anxiety. However, the community uptake of these programs is poor. Recent approaches to increasing engagement (defined as both uptake and adherence) in internet-based programs include brief engagement facilitation interventions (EFIs). However, these programs require evaluation to assess their efficacy. Objective: The aims of this hybrid implementation effectiveness trial are to examine the effects of a brief internet-based EFI presented before an internet-based cognitive behavioral therapy self-help program (myCompass 2) in improving engagement (uptake and adherence) with that program (primary aim), assess the relative efficacy of the myCompass 2 program, and determine whether greater engagement was associated with improved efficacy (greater reduction in depression or anxiety symptoms) relative to the control (secondary aim). Methods: A 3-arm randomized controlled trial (N=849; recruited via social media) assessed the independent efficacy of the EFI and myCompass 2. The myCompass 2 program was delivered with or without the EFI; both conditions were compared with an attention control condition. The EFI comprised brief (5 minutes), tailored audio-visual content on a series of click-through linear webpages. Results: Uptake was high in all groups; 82.8% (703/849) of participants clicked through the intervention following the pretest survey. However, the difference in uptake between the EFI + myCompass 2 condition (234/280, 83.6%) and the myCompass 2 alone condition (222/285, 77.9%) was not significant (n=565; χ21=29.2; P=.09). In addition, there was no significant difference in the proportion of participants who started any number of modules (1-14 modules) versus those who started none between the EFI + myCompass 2 (214/565, 37.9%) and the myCompass 2 alone (210/565, 37.2%) conditions (n=565; χ21<0.1; P=.87). Finally, there was no significant difference between the EFI + myCompass 2 and the myCompass 2 alone conditions in the number of modules started (U=39366.50; z=−0.32; P=.75) or completed (U=39494.0; z=−0.29; P=.77). The myCompass 2 program was not found to be efficacious over time for symptoms of depression (F4,349.97=1.16; P=.33) or anxiety (F4,445.99=0.12; P=.98). However, planned contrasts suggested that myCompass 2 may have been effective for participants with elevated generalized anxiety disorder symptoms (F4,332.80=3.50; P=.01). Conclusions: This brief internet-based EFI did not increase the uptake of or adherence to an existing internet-based program for depression and anxiety. Individuals’ motivation to initiate and complete internet-based self-guided interventions is complex and remains a significant challenge for self-guided interventions. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618001565235; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375839 %M 34313595 %R 10.2196/23029 %U https://www.jmir.org/2021/7/e23029 %U https://doi.org/10.2196/23029 %U http://www.ncbi.nlm.nih.gov/pubmed/34313595 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e26551 %T Exploring the Role of Web-Based Interventions in the Self-management of Dementia: Systematic Review and Narrative Synthesis %A Lee,Abigail Rebecca %A Gerritzen,Esther Vera %A McDermott,Orii %A Orrell,Martin %+ Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Jubilee Campus, Triumph Road, Nottingham, United Kingdom, 44 7890 021703, abigail.lee1@nottingham.ac.uk %K systematic review %K narrative synthesis %K dementia %K web %K app %K online %K mobile phone %K self-management %D 2021 %7 26.7.2021 %9 Review %J J Med Internet Res %G English %X Background: The increasing prevalence of dementia has promoted a move toward equipping people with the skills required for greater self-management of the condition to enable a better quality of life. Self-management encompasses numerous skills, such as goal setting and decision making, which aim to improve an individual’s physical and mental well-being when they live with long-term health conditions. Effective self-management may lead to increased well-being and quality of life. Reviews of web-based and app-based interventions have suggested that they have the potential to provide self-management support for people living with a range of conditions, including dementia. Objective: The aim of this review is to explore the existing use of web-based or app-based interventions that facilitate or support self-management in dementia and discuss their effectiveness in promoting self-management and independence. Methods: A total of 5 electronic databases were systematically searched for relevant articles published between January 2010 and March 2020. Included studies were appraised using the Downs and Black checklist and the Critical Appraisal Skills Program qualitative research checklist. A narrative synthesis framework was applied using tables and conceptual mapping to explore the relationships within and among studies. Results: A total of 2561 articles were identified from the initial search, of which 11 (0.43%) met the inclusion criteria for the final analysis. These included 5 quantitative, 4 mixed methods, and 2 qualitative studies. All the included articles were of fair to high quality across the two appraisal measures. Interventions were delivered through a range of web-based and app-based technologies and targeted several self-management concepts. However, there was inconsistency regarding the domains, often affected by dementia, that were targeted by the interventions reviewed. Conclusions: Web-based and app-based interventions for dementia can be delivered through a range of means and can target different aspects of self-management. The small number of studies included in this review report positive outcomes that seem to support the use of these interventions for people living with dementia. However, there is a clear need for more high-quality research into this type of intervention delivery and for studies that use a much larger number of participants across the dementia spectrum. Future research should consider the barriers to and facilitators of intervention adoption highlighted in this review and whether interventions can encompass the physical, social, cognitive, and emotional domains affected by dementia. %M 34309575 %R 10.2196/26551 %U https://www.jmir.org/2021/7/e26551 %U https://doi.org/10.2196/26551 %U http://www.ncbi.nlm.nih.gov/pubmed/34309575 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e21502 %T Efficacy, Use, and Acceptability of a Web-Based Self-management Intervention Designed to Maximize Sexual Well-being in Men Living With Prostate Cancer: Single-Arm Experimental Study %A O'Connor,Sean R %A Flannagan,Carrie %A Parahoo,Kader %A Steele,Mary %A Thompson,Samantha %A Jain,Suneil %A Kirby,Michael %A Brady,Nuala %A Maguire,Roma %A Connaghan,John %A McCaughan,Eilis M %+ Centre for Public Health, Queen's University Belfast, Institute of Clinical Science, Royal Victoria Hospital, Belfast, BT12 6BA, United Kingdom, 44 28 9097 6350, s.oconnor@qub.ac.uk %K prostate cancer %K sexual well-being %K digital interventions %K self-management %D 2021 %7 26.7.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Sexual dysfunction is a frequent side effect associated with different prostate cancer treatment approaches. It can have a substantial impact on men and their partners and is associated with increased psychological morbidity. Despite this, sexual concerns are often not adequately addressed in routine practice. Evidence-based web-based interventions have the potential to provide ongoing information and sexual well-being support throughout all stages of care. Objective: The aim of this study is to examine the efficacy of a web-based self-management intervention designed to maximize sexual well-being in men living with prostate cancer and explore user perspectives on usability and acceptability. Methods: We used a single-arm study design, and participants were provided with access to the 5-step intervention for a period of 3 months. The intervention content was tailored based on responses to brief screening questions on treatment type, relationship status, and sexual orientation. Efficacy was assessed by using two-tailed, paired sample t tests for comparing the mean differences between pre- and postintervention measurements for exploring the participants’ self-reported knowledge and understanding, sexual satisfaction, and comfort in discussing sexual issues. Usability and acceptability were determined based on the program use data and a postintervention survey for exploring perceived usefulness. Results: A total of 109 participants were recruited for this study. Significant postintervention improvements at follow-up were observed in the total scores (out of 20) from the survey (mean 12.23/20 points, SD 2.46 vs mean 13.62/20, SD 2.31; t88=9.570; P=.001) as well as in individual item scores on the extent to which the participants agreed that they had sufficient information to manage the impact that prostate cancer had on their sex life (mean 2.31/4 points, SD 0.86 vs mean 2.57/4, SD 0.85; t88=3.660; P=.001) and had the potential to have a satisfying sex life following treatment (mean 2.38/4 points, SD 0.79 vs mean 3.17/4, SD 0.78; t88=7.643; P=.001). The median number of intervention sessions was 3 (range 1-11), and intervention sessions had a median duration of 22 minutes (range 8-77). Acceptable usability scores were reported, with the highest result observed for the question on the extent to which the intervention provided relevant information. Conclusions: This study provides evidence on the efficacy of a tailored web-based intervention for maximizing sexual well-being in men living with prostate cancer. The results indicate that the intervention may improve one’s self-perceived knowledge and understanding of how to manage sexual issues and increase self-efficacy or the belief that a satisfactory sex life could be achieved following treatment. The findings will be used to refine the intervention content before testing as part of a larger longitudinal study for examining its effectiveness. %M 34309580 %R 10.2196/21502 %U https://www.jmir.org/2021/7/e21502 %U https://doi.org/10.2196/21502 %U http://www.ncbi.nlm.nih.gov/pubmed/34309580 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 4 %N 3 %P e26690 %T Evaluating Digital Program Support for the Physical Activity 4 Everyone (PA4E1) School Program: Mixed Methods Study %A Mclaughlin,Matthew %A Duff,Jed %A McKenzie,Tom %A Campbell,Elizabeth %A Sutherland,Rachel %A Wiggers,John %A Wolfenden,Luke %+ School of Medicine and Public Health, University of Newcastle, University Dr, Callaghan, 2308, Australia, 61 402448504, Matthew.Mclaughlin1@health.nsw.gov.au %K process evaluation %K engagement %K think-aloud methodology %K mixed methods %K physical activity %K website %K digital health intervention %K implementation support %K delivery mode %K scale-up %D 2021 %7 26.7.2021 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Effectively scaled-up physical activity interventions are urgently needed to address the high prevalence of physical inactivity. To facilitate scale-up of an efficacious school-based physical activity program (Physical Activity 4 Everyone [PA4E1]), provision of implementation support to physical education (PE) teachers was adapted from face-to-face and paper-based delivery modes to partial delivery via a website. A lack of engagement (usage and subjective experience) with digital delivery modes, including websites, may in part explain the typical reduction in effectiveness of scaled-up interventions that use digital delivery modes. A process evaluation focused on the PA4E1 website was undertaken. Objective: The 2 objectives were to (1) describe the usage of the PA4E1 program website by in-school champions (PE teachers leading the program within their schools) and PE teachers using quantitative methods; (2) examine the usage, subjective experience, and usability of the PA4E1 program website from the perspective of in-school champions using mixed methods. Methods: The first objective used website usage data collected across all users (n=273) throughout the 9 school terms of the PA4E1 implementation support. The 4 usage measures were sessions, page views, average session duration, and downloads. Descriptive statistics were calculated and explored across the duration of the 26-month program. The second objective used mixed methods, triangulating data from the first objective with data from a think-aloud survey and usability test completed by in-school champions (n=13) at 12 months. Qualitative data were analyzed thematically alongside descriptive statistics from the quantitative data in a triangulation matrix, generating cross-cutting themes using the “following a thread” approach. Results: For the first objective, in-school champions averaged 48.0 sessions per user, PE teachers 5.8 sessions. PE teacher sessions were of longer duration (10.5 vs 7.6 minutes) and included more page views (5.4 vs 3.4). The results from the mixed methods analysis for the second objective found 9 themes and 2 meta-themes. The first meta-theme indicated that the website was an acceptable and appropriate delivery mode, and usability of the website was high. The second meta-theme found that the website content was acceptable and appropriate, and identified specific suggestions for improvement. Conclusions: Digital health interventions targeting physical activity often experience issues of lack of user engagement. By contrast, the findings from both the quantitative and mixed methods analyses indicate high usage and overall acceptability and appropriateness of the PA4E1 website to school teachers. The findings support the value of the website within a multidelivery mode implementation intervention to support schools to implement physical activity promoting practices. The analysis identified suggested intervention refinements, which may be adopted for future iterations and further scale-up of the PA4E1 program. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12617000681358; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372870 %M 34309565 %R 10.2196/26690 %U https://pediatrics.jmir.org/2021/3/e26690 %U https://doi.org/10.2196/26690 %U http://www.ncbi.nlm.nih.gov/pubmed/34309565 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 7 %P e22709 %T Internet-Administered Cognitive Behavioral Therapy for Common Mental Health Difficulties in Parents of Children Treated for Cancer: Intervention Development and Description Study %A Woodford,Joanne %A Farrand,Paul %A Hagström,Josefin %A Hedenmalm,Li %A von Essen,Louise %+ Uppsala University, Healthcare Sciences and e-Health, Department of Women’s and Children’s Health, MTC-huset: Dag Hammarskjölds väg 14B, 1 tr, Uppsala, 751 85, Sweden, 46 070 4250714, louise-von.essen@kbh.uu.se %K parents %K eMental health %K internet-administered cognitive behavioral therapy %K ICBT %K TIDieR %K CBT self-help %K low-intensity CBT %K mobile phone %D 2021 %7 22.7.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Following the end of a child’s treatment for cancer, parents may report psychological distress. However, there is a lack of evidence-based interventions that are tailored to the population, and psychological support needs are commonly unmet. An internet-administered low-intensity cognitive behavioral therapy (LICBT)–based intervention (EJDeR [internetbaserad självhjälp för föräldrar till barn som avslutat en behandling mot cancer]) may provide a solution. Objective: The first objective is to provide an overview of a multimethod approach that was used to inform the development of the EJDeR intervention. The second objective is to provide a detailed description of the EJDeR intervention in accordance with the Template for Intervention Description and Replication (TIDieR) checklist. Methods: EJDeR was developed through a multimethod approach, which included the use of existing evidence, the conceptualization of distress, participatory action research, a cross-sectional survey, and professional and public involvement. Depending on the main presenting difficulty identified during assessment, LICBT behavioral activation or worry management treatment protocols are adopted for the treatment of depression or generalized anxiety disorder when experienced individually or when comorbid. EJDeR is delivered via the Uppsala University Psychosocial Care Programme (U-CARE) portal, a web-based platform that is designed to deliver internet-administered LICBT interventions and includes secure videoconferencing. To guide parents in the use of EJDeR, weekly written messages via the portal are provided by e-therapists comprising final year psychology program students with training in cognitive behavioral therapy. Results: An overview of the development process and a description of EJDeR, which was informed by the TIDieR checklist, are presented. Adaptations that were made in response to public involvement are highlighted. Conclusions: EJDeR represents a novel, guided, internet-administered LICBT intervention for supporting parents of children treated for cancer. Adopting the TIDieR checklist offers the potential to enhance fidelity to the intervention protocol and facilitate later implementation. The intervention is currently being tested in a feasibility study (the ENGAGE study). International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2018-023708 %M 34142662 %R 10.2196/22709 %U https://formative.jmir.org/2021/7/e22709 %U https://doi.org/10.2196/22709 %U http://www.ncbi.nlm.nih.gov/pubmed/34142662 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 7 %P e24308 %T Smartphone-Based Interventions for Physical Activity Promotion: Scoping Review of the Evidence Over the Last 10 Years %A Domin,Alex %A Spruijt-Metz,Donna %A Theisen,Daniel %A Ouzzahra,Yacine %A Vögele,Claus %+ Research Group: Self-Regulation and Health, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Maison des Sciences Humaines, 11, Porte des Sciences, Esch-sur-Alzette, L-4366, Luxembourg, 352 46 66 44 9389, alex.domin@uni.lu %K scoping review %K smartphone application %K physical activity %K behavior change %K mobile health %K research design %K mHealth %K adolescents %K adults %K BCT %K mobile phonescoping review %K smartphone application %K physical activity %K behavior change %K mobile health %K research design %K mHealth %K adolescents %K adults %K BCT %K mobile phone %D 2021 %7 21.7.2021 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Several reviews of mobile health (mHealth) physical activity (PA) interventions suggest their beneficial effects on behavior change in adolescents and adults. Owing to the ubiquitous presence of smartphones, their use in mHealth PA interventions seems obvious; nevertheless, there are gaps in the literature on the evaluation reporting processes and best practices of such interventions. Objective: The primary objective of this review is to analyze the development and evaluation trajectory of smartphone-based mHealth PA interventions and to review systematic theory- and evidence-based practices and methods that are implemented along this trajectory. The secondary objective is to identify the range of evidence (both quantitative and qualitative) available on smartphone-based mHealth PA interventions to provide a comprehensive tabular and narrative review of the available literature in terms of its nature, features, and volume. Methods: We conducted a scoping review of qualitative and quantitative studies examining smartphone-based PA interventions published between 2008 and 2018. In line with scoping review guidelines, studies were not rejected based on their research design or quality. This review, therefore, includes experimental and descriptive studies, as well as reviews addressing smartphone-based mHealth interventions aimed at promoting PA in all age groups (with a subanalysis conducted for adolescents). Two groups of studies were additionally included: reviews or content analyses of PA trackers and meta-analyses exploring behavior change techniques and their efficacy. Results: Included articles (N=148) were categorized into 10 groups: commercial smartphone app content analyses, smartphone-based intervention review studies, activity tracker content analyses, activity tracker review studies, meta-analyses of PA intervention studies, smartphone-based intervention studies, qualitative formative studies, app development descriptive studies, qualitative follow-up studies, and other related articles. Only 24 articles targeted children or adolescents (age range: 5-19 years). There is no agreed evaluation framework or taxonomy to code or report smartphone-based PA interventions. Researchers did not state the coding method, used various evaluation frameworks, or used different versions of behavior change technique taxonomies. In addition, there is no consensus on the best behavior change theory or model that should be used in smartphone-based interventions for PA promotion. Commonly reported systematic practices and methods have been successfully identified. They include PA recommendations, trial designs (randomized controlled trials, experimental trials, and rapid design trials), mixed methods data collection (surveys, questionnaires, interviews, and focus group discussions), scales to assess app quality, and industry-recognized reporting guidelines. Conclusions: Smartphone-based mHealth interventions aimed at promoting PA showed promising results for behavior change. Although there is a plethora of published studies on the adult target group, the number of studies and consequently the evidence base for adolescents is limited. Overall, the efficacy of smartphone-based mHealth PA interventions can be considerably improved through a more systematic approach of developing, reporting, and coding of the interventions. %M 34287209 %R 10.2196/24308 %U https://mhealth.jmir.org/2021/7/e24308 %U https://doi.org/10.2196/24308 %U http://www.ncbi.nlm.nih.gov/pubmed/34287209 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 7 %P e27891 %T Associations Between Physiological Signals Captured Using Wearable Sensors and Self-reported Outcomes Among Adults in Alcohol Use Disorder Recovery: Development and Usability Study %A Alinia,Parastoo %A Sah,Ramesh Kumar %A McDonell,Michael %A Pendry,Patricia %A Parent,Sara %A Ghasemzadeh,Hassan %A Cleveland,Michael John %+ Department of Human Development, Washington State University, 501 Johnson Tower, Pullman, WA, 99164, United States, 1 509 335 2870, michael.cleveland@wsu.edu %K alcohol relapse prevention %K stress markers %K alcohol consumption %K electrodermal activity %K heart rate variability %K emotion %K mobile phone %D 2021 %7 21.7.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Previous research has highlighted the role of stress in substance misuse and addiction, particularly for relapse risk. Mobile health interventions that incorporate real-time monitoring of physiological markers of stress offer promise for delivering tailored interventions to individuals during high-risk states of heightened stress to prevent alcohol relapse. Before such interventions can be developed, measurements of these processes in ambulatory, real-world settings are needed. Objective: This research is a proof-of-concept study to establish the feasibility of using a wearable sensor device to continuously monitor stress in an ambulatory setting. Toward that end, we first aimed to examine the quality of 2 continuously monitored physiological signals—electrodermal activity (EDA) and heart rate variability (HRV)—and show that the data follow standard quality measures according to the literature. Next, we examined the associations between the statistical features extracted from the EDA and HRV signals and self-reported outcomes. Methods: Participants (N=11; female: n=10) were asked to wear an Empatica E4 wearable sensor for continuous unobtrusive physiological signal collection for up to 14 days. During the same time frame, participants responded to a daily diary study using ecological momentary assessment of self-reported stress, emotions, alcohol-related cravings, pain, and discomfort via a web-based survey, which was conducted 4 times daily. Participants also participated in structured interviews throughout the study to assess daily alcohol use and to validate self-reported and physiological stress markers. In the analysis, we first used existing artifact detection methods and physiological signal processing approaches to assess the quality of the physiological data. Next, we examined the descriptive statistics for self-reported outcomes. Finally, we investigated the associations between the features of physiological signals and self-reported outcomes. Results: We determined that 87.86% (1,032,265/1,174,898) of the EDA signals were clean. A comparison of the frequency of skin conductance responses per minute with previous research confirmed that the physiological signals collected in the ambulatory setting were successful. The results also indicated that the statistical features of the EDA and HRV measures were significantly correlated with the self-reported outcomes, including the number of stressful events marked on the sensor device, positive and negative emotions, and experienced pain and discomfort. Conclusions: The results demonstrated that the physiological data collected via an Empatica E4 wearable sensor device were consistent with previous literature in terms of the quality of the data and that features of these physiological signals were significantly associated with several self-reported outcomes among a sample of adults diagnosed with alcohol use disorder. These results suggest that ambulatory assessment of stress is feasible and can be used to develop tailored mobile health interventions to enhance sustained recovery from alcohol use disorder. %M 34287205 %R 10.2196/27891 %U https://formative.jmir.org/2021/7/e27891 %U https://doi.org/10.2196/27891 %U http://www.ncbi.nlm.nih.gov/pubmed/34287205 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e17874 %T The Efficacy of eHealth Interventions for the Treatment of Adults Diagnosed With Full or Subthreshold Binge Eating Disorder: Systematic Review and Meta-analysis %A Moghimi,Elnaz %A Davis,Caroline %A Rotondi,Michael %+ School of Kinesiology and Health Science, Faculty of Health, York University, 4700 Keele Street, Toronto, ON, M3J 1P3, Canada, 1 416 736 2100 ext 77239, elnazm@yorku.ca %K internet %K cognitive behavioral therapy %K guided self-help %K obesity %K weight loss %K eating disorder %K binge eating %K mobile phone %D 2021 %7 20.7.2021 %9 Review %J J Med Internet Res %G English %X Background: There has been a recent rise in the use of eHealth treatments for a variety of psychological disorders, including eating disorders. Objective: This meta-analysis of randomized controlled trials is the first to evaluate the efficacy of eHealth interventions specifically for the treatment of binge eating disorder (characterized by compulsive overconsumption of food, in a relatively short period, and without compensatory behaviors such as purging or fasting). Methods: A search on the electronic databases PubMed, Web of Science, Embase, MEDLINE, and CINAHL was conducted for randomized controlled trials that compared the efficacy of eHealth treatment interventions with waitlist controls. Results: From the databases searched, 3 studies (298 participants in total) met the inclusion criteria. All interventions were forms of internet-based guided cognitive behavioral therapy. The results of the analysis demonstrated that when compared with waitlist controls, individuals enrolled in eHealth interventions experienced a reduction in objective binge episodes (standardized mean difference [SMD] −0.77, 95% CI −1.38 to −0.16) and eating disorder psychopathology (SMD −0.71, 95% CI −1.20 to −0.22), which included shape (SMD −0.61, 95% CI −1.01 to −0.22) and weight concerns (SMD −0.91, 95% CI −1.33 to −0.48). There was no significant difference in BMI between the eHealth interventions and controls (SMD −0.01, 95% CI −0.40 to 0.39). Conclusions: These findings provide promising results for the use of internet-based cognitive behavioral therapy for binge eating disorder treatment and support the need for future research to explore the efficacy of these eHealth interventions. %M 34283028 %R 10.2196/17874 %U https://www.jmir.org/2021/7/e17874 %U https://doi.org/10.2196/17874 %U http://www.ncbi.nlm.nih.gov/pubmed/34283028 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 7 %P e30334 %T Combining Ketamine and Internet-Based Cognitive Behavioral Therapy for the Treatment of Posttraumatic Stress Disorder: Protocol for a Randomized Controlled Trial %A Philipp-Muller,Aaron Emile %A Reshetukha,Taras %A Vazquez,Gustavo %A Milev,Roumen %A Armstrong,Dawn %A Jagayat,Jasleen %A Alavi,Nazanin %+ Centre for Neuroscience Studies, Queen's University, Botterell Hall, 18 Stuart St., Kingston, ON, K7L 3N6, Canada, 1 (613) 544 3310, 19aepm1@queensu.ca %K mental health %K PTSD %K psychotherapy %K cognitive behavioral therapy %K online %K internet %K electronic %K virtual %K mental health care %K ketamine %D 2021 %7 20.7.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Over one third of patients with posttraumatic stress disorder (PTSD) do not respond to current interventions. Ketamine presents a potential treatment option; however, its effects are temporary. Administering ketamine alongside psychotherapy is one potential means of prolonging its effects; however, only a few studies have investigated this treatment method to date, and none have tested ketamine with internet-based or electronically delivered cognitive behavioral therapy (e-CBT). Objective: This open-label randomized controlled trial aims to assess the efficacy of a combined treatment method of subanesthetic intravenous ketamine and e-CBT for treating patients with PTSD. Methods: In total, 20 patients with refractory PTSD recruited from a community clinic will be randomly assigned to either an experimental group (n=10), receiving a combination of ketamine and therapist-administered e-CBT over 14 weeks, or a waitlist control group (n=10), receiving the experimental treatment after 14 weeks. Both groups will be assessed for the symptoms of PTSD and comorbid disorders before treatment, at two midway points, and at the end of the experiment. Results: PTSD symptoms of participants in the experimental group are expected to improve significantly more than those of participants in the waitlist control group (P=.05) with a large effect size (η2=0.14). Conclusions: This is the first study to assess the relationship between e-CBT and ketamine and their combined ability to treat refractory PTSD. If successful, this study will open web-based, asynchronous therapeutic options for patients with PTSD and will provide new insights into the functional role of glutamate in trauma-related disorders as well as in learning, memory, and fear extinction. Trial Registration: ClinicalTrials.gov NCT04771767; https://clinicaltrials.gov/ct2/show/NCT04771767. International Registered Report Identifier (IRRID): PRR1-10.2196/30334 %M 34092549 %R 10.2196/30334 %U https://www.researchprotocols.org/2021/7/e30334 %U https://doi.org/10.2196/30334 %U http://www.ncbi.nlm.nih.gov/pubmed/34092549 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 7 %P e28168 %T New Evidence in the Booming Field of Online Mindfulness: An Updated Meta-analysis of Randomized Controlled Trials %A Sommers-Spijkerman,Marion %A Austin,Judith %A Bohlmeijer,Ernst %A Pots,Wendy %+ Department of Rehabilitation, Physical Therapy Science and Sports, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, 3584 CX, Netherlands, 31 652783025, m.p.j.spijkerman-6@umcutrecht.nl %K mindfulness %K mental health %K intervention %K online %K meta-analysis %K mobile phone %D 2021 %7 19.7.2021 %9 Review %J JMIR Ment Health %G English %X Background: There is a need to regularly update the evidence base on the effectiveness of online mindfulness-based interventions (MBIs), especially considering how fast this field is growing and developing. Objective: This study presents an updated meta-analysis of randomized controlled trials assessing the effects of online MBIs on mental health and the potential moderators of these effects. Methods: We conducted a systematic literature search in PsycINFO, PubMed, and Web of Science up to December 4, 2020, and included 97 trials, totaling 125 comparisons. Pre-to-post and pre-to-follow-up between-group effect sizes (Hedges g) were calculated for depression, anxiety, stress, well-being, and mindfulness using a random effects model. Results: The findings revealed statistically significant moderate pre-to-post effects on depression (g=0.34, 95% CI 0.18-0.50; P<.001), stress (g=0.44, 95% CI 0.32-0.55; P<.001), and mindfulness (g=0.40, 95% CI 0.30-0.50; P<.001) and small effects on anxiety (g=0.26, 95% CI 0.18-0.33; P<.001). For well-being, a significant small effect was found only when omitting outliers (g=0.22, 95% CI 0.15-0.29; P<.001) or low-quality studies (g=0.26, 95% CI 0.12-0.41; P<.001). Significant but small follow-up effects were found for depression (g=0.25, 95% CI 0.12-0.38) and anxiety (g=0.23, 95% CI 0.13-0.32). Subgroup analyses revealed that online MBIs resulted in higher effect sizes for stress when offered with guidance. In terms of stress and mindfulness, studies that used inactive control conditions yielded larger effects. For anxiety, populations with psychological symptoms had higher effect sizes. Adherence rates for the interventions ranged from 35% to 92%, but most studies lacked clear definitions or cut-offs. Conclusions: Our findings not only demonstrate that online MBIs are booming but also corroborate previous findings that online MBIs are beneficial for improving mental health outcomes in a broad range of populations. To advance the field of online MBIs, future trials should pay specific attention to methodological quality, adherence, and long-term follow-up measurements. %M 34279240 %R 10.2196/28168 %U https://mental.jmir.org/2021/7/e28168 %U https://doi.org/10.2196/28168 %U http://www.ncbi.nlm.nih.gov/pubmed/34279240 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 7 %P e28321 %T Intervention Use and Symptom Change With Unguided Internet-Based Cognitive Behavioral Therapy for Depression During the COVID-19 Pandemic: Log Data Analysis of a Convenience Sample %A Oehler,Caroline %A Scholze,Katharina %A Reich,Hanna %A Sander,Christian %A Hegerl,Ulrich %+ Forschungszentrum Depression, Stiftung Deutsche Depressionshilfe, Goerdelerring 9, Leipzig, 04109, Germany, 49 34122387420, caroline.oehler@medizin.uni-leipzig.de %K iCBT %K internet-based cognitive behavioral therapy %K internet-based treatment %K internet- and mobile-based intervention %K depression %K guidance %K unguided %K COVID-19 %D 2021 %7 16.7.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: Internet- and mobile-based interventions are most efficacious in the treatment of depression when they involve some form of guidance, but providing guidance requires resources such as trained personnel, who might not always be available (eg, during lockdowns to contain the COVID-19 pandemic). Objective: The current analysis focuses on changes in symptoms of depression in a guided sample of patients with depression who registered for an internet-based intervention, the iFightDepression tool, as well as the extent of intervention use, compared to an unguided sample. The objective is to further understand the effects of guidance and adherence on the intervention’s potential to induce symptom change. Methods: Log data from two convenience samples in German routine care were used to assess symptom change after 6-9 weeks of intervention as well as minimal dose (finishing at least two workshops). A linear regression model with changes in Patient Health Questionnaire (PHQ-9) score as a dependent variable and guidance and minimal dose as well as their interaction as independent variables was specified. Results: Data from 1423 people with symptoms of depression (n=940 unguided, 66.1%) were included in the current analysis. In the linear regression model predicting symptom change, a significant interaction of guidance and minimal dose revealed a specifically greater improvement for patients who received guidance and also worked with the intervention content (β=–1.75, t=–2.37, P=.02), while there was little difference in symptom change due to guidance in the group that did not use the intervention. In this model, the main effect of guidance was only marginally significant (β=–.53, t=–1.78, P=.08). Conclusions: Guidance in internet-based interventions for depression is not only an important factor to facilitate adherence, but also seems to further improve results for patients adhering to the intervention compared to those who do the same but without guidance. %M 34115604 %R 10.2196/28321 %U https://mental.jmir.org/2021/7/e28321 %U https://doi.org/10.2196/28321 %U http://www.ncbi.nlm.nih.gov/pubmed/34115604 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e25537 %T A Digital Intervention for Primary Care Practitioners to Support Antidepressant Discontinuation (Advisor for Health Professionals): Development Study %A Bowers,Hannah %A Kendrick,Tony %A van Ginneken,Nadja %A Glowacka,Marta %A Williams,Samantha %A Leydon,Geraldine M %A May,Carl %A Dowrick,Christopher %A Moncrieff,Joanna %A Johnson,Chris F %A Moore,Michael %A Laine,Rebecca %A Geraghty,Adam W A %+ Primary Care, Population Sciences and Medical Education, University of Southampton, Aldermoor, Southampton, SO15 5HT, United Kingdom, 44 2380591743, h.m.bowers@soton.ac.uk %K antidepressant discontinuation %K intervention development %K depression %K primary care %K digital intervention %D 2021 %7 16.7.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The number of people receiving antidepressants has increased in the past 3 decades, mainly because of people staying on them longer. However, in many cases long-term treatment is not evidence based and risks increasing side effects. Additionally, prompting general practitioners (GPs) to review medication does not improve the rate of appropriate discontinuation. Therefore, GPs and other health professionals may need help to support patients discontinuing antidepressants in primary care. Objective: This study aims to develop a digital intervention to support practitioners in helping patients discontinue inappropriate long-term antidepressants (as part of a wider intervention package including a patient digital intervention and patient telephone support). Methods: A prototype digital intervention called Advisor for Health Professionals (ADvisor HP) was planned and developed using theory, evidence, and a person-based approach. The following elements informed development: a literature review and qualitative synthesis, an in-depth qualitative study, the development of guiding principles for design elements, and theoretical behavioral analyses. The intervention was then optimized through think-aloud qualitative interviews with health professionals while they were using the prototype intervention. Results: Think-aloud qualitative interviews with 19 health professionals suggested that the digital intervention contained useful information and was readily accessible to practitioners. The development work highlighted a need for further guidance on drug tapering schedules for practitioners and clarity about who is responsible for broaching the subject of discontinuation. Practitioners highlighted the need to have information in easily and quickly accessible formats because of time constraints in day-to-day practice. Some GPs felt that some information was already known to them but understood why this was included. Practitioners differed in their ideas about how they would use ADvisor HP in practice, with some preferring to read the resource in its entirety and others wanting to dip in and out as needed. Changes were made to the wording and structure of the intervention in response to the feedback provided. Conclusions: ADvisor HP is a digital intervention that has been developed using theory, evidence, and a person-based approach. The optimization work suggests that practitioners may find this tool to be useful in supporting the reduction of long-term antidepressant use. Further quantitative and qualitative evaluation through a randomized controlled trial is needed to examine the feasibility, effectiveness, and cost-effectiveness of the intervention. %M 34269688 %R 10.2196/25537 %U https://www.jmir.org/2021/7/e25537 %U https://doi.org/10.2196/25537 %U http://www.ncbi.nlm.nih.gov/pubmed/34269688 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e23227 %T The Effects of Continuous Usage of a Diabetes Management App on Glycemic Control in Real-world Clinical Practice: Retrospective Analysis %A Tu,Yu-Zhen %A Chang,Ya-Ting %A Chiou,Hung-Yi %A Lai,Ken %+ H2 Inc, 4F, No 32, Aly 18, Ln 478, Ruiguang Rd, Neihu Dist, Taipei, Taiwan, 886 287976661 ext 105, klai@health2sync.com %K app %K diabetes care %K diabetes %K digital intervention %K digital therapeutics %K glycemic control %K mobile app %K mHealth %K real-world data %K therapy %D 2021 %7 15.7.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The efficacy of digital technology in improving diabetes management has typically been demonstrated through studies such as randomized controlled trials, which have reported a steeper reduction in hemoglobin A1c (HbA1c) values for patients who adopted a digital solution. However, evidence from real-world clinical practice is still limited. Objective: This study aimed to evaluate the effectiveness of digital interventions by tracking HbA1c improvements over 1 year in real-world clinical settings. Methods: Patients used the Health2Sync mobile app to track self-measured outcomes and communicate with health care professionals (HCPs). HCPs used the web-based Patient Management Platform to monitor patient data, view test results from clinical laboratories, and communicate with patients. Patients who have been onboarded for at least 13 months and have consecutive HbA1c findings for 5 quarters were included in the analysis. They were then stratified into 3 groups (high, mid, and low retention) based on their level of use of Health2Sync in the first 6 months of onboarding. A mixed model was built to compare the slopes of the rate of reduction in HbA1c among the groups. In addition, these patients’ retention on the app from the seventh to the 12th month was verified through multiple comparisons. Results: A sample of 2036 users was included in the analysis. With the mixed model coefficient estimates, we found that app users had significant HbA1c percentage reductions as the passed quarter count increased (t=–9.869; P<.001), and that effectiveness increased in the high (t=–5.173) and mid retention (t=–6.620) groups as the interaction effects were significantly negative compared to that in the low retention group (P<.001) in the passed quarter count. The low retention group also had the highest average HbA1c value at the end of 13 months (high: 7.01%, SD 1.02%; mid: 6.99%, SD 1.00%; low: 7.17%, SD 1.14%) (Bonferroni correction: high vs low, P=.07; mid vs low, P=.02; high vs mid, P>.99). The level of use of the app remained consistent in the seventh to the 12th month after onboarding (high: 5.23 [SD 1.37] months, mid: 2.43 [SD 1.68] months, low: 0.41 [SD 0.97] months) (P<.001). Conclusions: Our analysis shows that continuous usage of the diabetes management app is associated with better glycemic control in real-world clinical practice. Further studies are required to reveal the efficacy for specific diabetes types and to observe effects beyond 1 year. %M 34264192 %R 10.2196/23227 %U https://www.jmir.org/2021/7/e23227 %U https://doi.org/10.2196/23227 %U http://www.ncbi.nlm.nih.gov/pubmed/34264192 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 7 %P e16949 %T Barriers to the Use of Web-Based Mental Health Programs for Preventing Depression: Qualitative Study %A Eccles,Heidi %A Nannarone,Molly %A Lashewicz,Bonnie %A Attridge,Mark %A Marchand,Alain %A Aiken,Alice %A Ho,Kendall %A Wang,JianLi %+ The Institute of Mental Health Research, University of Ottawa, Room 5404, 1145 Carling Ave, Ottawa, ON, K1Z 7K4, Canada, 1 6137226521 ext 6057, jlwang@ucalgary.ca %K prevention %K mental health %K depression %K problem solving therapy %K barriers %K web-based program %K qualitative study %D 2021 %7 15.7.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Depression has a profound impact on population health. Although using web-based mental health programs to prevent depression has been found to be effective in decreasing depression incidence, there are obstacles preventing their use, as reflected by the low rates of use and adherence. Objective: The aims of the study are to understand the barriers to using web-based mental health programs for the prevention of depression and the possible dangers or concerns regarding the use of such programs. Methods: BroMatters and HardHat were two randomized controlled trials (RCTs) that evaluated the effectiveness of e–mental health programs for preventing workplace depression. In the BroMatters RCT, only working men who were at high risk of having a major depressive episode were included. The participants were assigned to either the control group or 1 of 2 intervention groups. The control participants had access to the general depression information on the BroMatters website. Intervention group 1 had access to BroMatters and BroHealth—the depression prevention program. Intervention group 2 had access to BroMatters and BroHealth along with weekly access to a qualified coach through telephone calls. The HardHat trial targeted both men and women at high risk of having a major depressive episode. The participants in the intervention group were given access to the HardHat depression prevention program (which included a web-based coach), whereas HardHat access was only granted to the control group once the study was completed. This qualitative study recruited male participants from the intervention groups of the two RCTs. A total of 2 groups of participants were recruited from the BroMatters study (after a baseline interview: n=41; 1 month after the RCT: n=20; 61/744, 8.2%), and 1 group was recruited from the HardHat RCT 1 month after the initial quantitative interview (9/103, 8.7%). Semistructured interviews were performed with the participants (70/847, 8.3%) and analyzed using content analysis. Results: There were both personal and program-level barriers to program use. The three personal barriers included time, stress level, and the perception of depression prevention. Content, functionality, and dangers were the program-level barriers to the use of web-based mental health programs. Large amounts of text and functionality issues within the programs decreased participants’ engagement. The dangers associated with web-based mental health programs included privacy breaches and inadequate help for severe symptoms. Conclusions: There are personal and program-level barriers to the use of web-based mental health programs. The stigmatization of help seeking for depression symptoms affects the time spent on the program, as does the public perception of depression. Certain barriers may be mitigated by program updates, whereas others may require a complete shift in the perception of depression prevention. %M 34264195 %R 10.2196/16949 %U https://formative.jmir.org/2021/7/e16949 %U https://doi.org/10.2196/16949 %U http://www.ncbi.nlm.nih.gov/pubmed/34264195 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e28244 %T Behavioral Activation and Depression Symptomatology: Longitudinal Assessment of Linguistic Indicators in Text-Based Therapy Sessions %A Burkhardt,Hannah A %A Alexopoulos,George S %A Pullmann,Michael D %A Hull,Thomas D %A Areán,Patricia A %A Cohen,Trevor %+ Department of Biomedical Informatics and Medical Education, University of Washington, 850 Republican St, Seattle, WA, 98109, United States, 1 206 897 4636, haalbu@uw.edu %K natural language processing %K text analysis %K behavioral activation %K depression %K digital interventions %K mental health %D 2021 %7 14.7.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Behavioral activation (BA) is rooted in the behavioral theory of depression, which states that increased exposure to meaningful, rewarding activities is a critical factor in the treatment of depression. Assessing constructs relevant to BA currently requires the administration of standardized instruments, such as the Behavioral Activation for Depression Scale (BADS), which places a burden on patients and providers, among other potential limitations. Previous work has shown that depressed and nondepressed individuals may use language differently and that automated tools can detect these differences. The increasing use of online, chat-based mental health counseling presents an unparalleled resource for automated longitudinal linguistic analysis of patients with depression, with the potential to illuminate the role of reward exposure in recovery. Objective: This work investigated how linguistic indicators of planning and participation in enjoyable activities identified in online, text-based counseling sessions relate to depression symptomatology over time. Methods: Using distributional semantics methods applied to a large corpus of text-based online therapy sessions, we devised a set of novel BA-related categories for the Linguistic Inquiry and Word Count (LIWC) software package. We then analyzed the language used by 10,000 patients in online therapy chat logs for indicators of activation and other depression-related markers using LIWC. Results: Despite their conceptual and operational differences, both previously established LIWC markers of depression and our novel linguistic indicators of activation were strongly associated with depression scores (Patient Health Questionnaire [PHQ]-9) and longitudinal patient trajectories. Emotional tone; pronoun rates; words related to sadness, health, and biology; and BA-related LIWC categories appear to be complementary, explaining more of the variance in the PHQ score together than they do independently. Conclusions: This study enables further work in automated diagnosis and assessment of depression, the refinement of BA psychotherapeutic strategies, and the development of predictive models for decision support. %M 34259637 %R 10.2196/28244 %U https://www.jmir.org/2021/7/e28244 %U https://doi.org/10.2196/28244 %U http://www.ncbi.nlm.nih.gov/pubmed/34259637 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 7 %P e18741 %T Assessing the Contribution of Self-Monitoring Through a Commercial Weight Loss App: Mediation and Predictive Modeling Study %A Farage,Gregory %A Simmons,Courtney %A Kocak,Mehmet %A Klesges,Robert C %A Talcott,G Wayne %A Richey,Phyllis %A Hare,Marion %A Johnson,Karen C %A Sen,Saunak %A Krukowski,Rebecca %+ Department of Preventive Medicine, College of Medicine, University of Tennessee Health Science Center, 66 N Pauline St, Memphis, TN, 38163, United States, 1 901 448 2426, rkrukows@uthsc.edu %K weight loss %K self-monitoring %K obesity %K apps %K behavioral intervention %D 2021 %7 14.7.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Electronic self-monitoring technology has the potential to provide unique insights into important behaviors for inducing weight loss. Objective: The aim of this study is to investigate the effects of electronic self-monitoring behavior (using the commercial Lose It! app) and weight loss interventions (with differing amounts of counselor feedback and support) on 4- and 12-month weight loss. Methods: In this secondary analysis of the Fit Blue study, we compared the results of two interventions of a randomized controlled trial. Counselor-initiated participants received consistent support from the interventionists, and self-paced participants received assistance upon request. The participants (N=191), who were active duty military personnel, were encouraged to self-monitor their diet and exercise with the Lose It! app or website. We examined the associations between intervention assignment and self-monitoring behaviors. We conducted a mediation analysis of the intervention assignment for weight loss through multiple mediators—app use (calculated from the first principal component [PC] of electronically collected variables), number of weigh-ins, and 4-month weight change. We used linear regression to predict weight loss at 4 and 12 months, and the accuracy was measured using cross-validation. Results: On average, the counselor-initiated–treatment participants used the app more frequently than the self-paced–treatment participants. The first PC represented app use frequencies, the second represented calories recorded, and the third represented reported exercise frequency and exercise caloric expenditure. We found that 4-month weight loss was partially mediated through app use (ie, the first PC; 60.3%) and the number of weigh-ins (55.8%). However, the 12-month weight loss was almost fully mediated by 4-month weight loss (94.8%). Linear regression using app data from the first 8 weeks, the number of self–weigh-ins at 8 weeks, and baseline data explained approximately 30% of the variance in 4-month weight loss. App use frequency (first PC; P=.001), self-monitored caloric intake (second PC; P=.001), and the frequency of self-weighing at 8 weeks (P=.008) were important predictors of 4-month weight loss. Predictions for 12-month weight with the same variables produced an R2 value of 5%; only the number of self–weigh-ins was a significant predictor of 12-month weight loss. The R2 value using 4-month weight loss as a predictor was 31%. Self-reported exercise did not contribute to either model (4 months: P=.77; 12 months: P=.15). Conclusions: We found that app use and daily reported caloric intake had a substantial impact on weight loss prediction at 4 months. Our analysis did not find evidence of an association between participant self-monitoring exercise information and weight loss. As 12-month weight loss was completely mediated by 4-month weight loss, intervention targets should focus on promoting early and frequent dietary intake self-monitoring and self-weighing to promote early weight loss, which leads to long-term success. Trial Registration: ClinicalTrials.gov NCT02063178; https://clinicaltrials.gov/ct2/show/NCT02063178 %M 34259635 %R 10.2196/18741 %U https://mhealth.jmir.org/2021/7/e18741 %U https://doi.org/10.2196/18741 %U http://www.ncbi.nlm.nih.gov/pubmed/34259635 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 7 %P e26951 %T A Mobile Phone–Based Life-Skills Training Program for Substance Use Prevention Among Adolescents: Cluster-Randomized Controlled Trial %A Haug,Severin %A Paz Castro,Raquel %A Wenger,Andreas %A Schaub,Michael Patrick %+ Swiss Research Institute for Public Health and Addiction at Zurich University, Konradstrasse 32, Zurich, 8005, Switzerland, 41 444481174, severin.haug@isgf.uzh.ch %K life skills %K substance use %K prevention %K adolescents %K mobile phone %D 2021 %7 13.7.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Life skills are abilities for adaptive and positive behavior that enable individuals to deal effectively with the demands and challenges of everyday life. Life-skills training programs conducted within the school curriculum are effective in preventing the onset and escalation of substance use among adolescents. However, their dissemination is impeded due to their large resource requirements. Life-skills training provided via mobile phones may provide a more economic and scalable approach. Objective: The goal of this study was to test the appropriateness (ie, acceptance, use, and evaluation) and short-term efficacy of a mobile phone–based life-skills training program to prevent substance use among adolescents within a controlled trial. Methods: The study design was a two-arm, parallel-group, cluster-randomized controlled trial with assessments at baseline and follow-up assessments after 6 and 18 months. This report includes outcomes measured up to the 6-month follow-up. The efficacy of the intervention was tested in comparison to an assessment-only control group. The automated intervention program SmartCoach included online feedback and individually tailored text messages provided over 22 weeks. The contents were based on social cognitive theory and addressed self-management skills, social skills, and substance use resistance skills. Linear mixed models and generalized linear mixed models, as well as logistic or linear regressions, were used to investigate changes between baseline and 6-month follow-up in the following outcomes: 30-day prevalence rates of problem drinking, tobacco use, and cannabis use as well as quantity of alcohol use, quantity of cigarettes smoked, cannabis use days, perceived stress, well-being, and social skills. Results: A total of 1759 students from 89 Swiss secondary and upper secondary school classes were invited to participate in the study. Of these, 1473 (83.7%) students participated in the study; the mean age was 15.4 years (SD 1.0) and 55.2% (813/1473) were female. Follow-up assessments at 6 months were completed by 1233 (83.7%) study participants. On average, program participants responded to half (23.6 out of 50) of the prompted activities. Program evaluations underlined its appropriateness for the target group of secondary school students, with the majority rating the program as helpful and individually tailored. The results concerning the initial effectiveness of this program based on 6-month follow-up data are promising, with three of nine outcomes of the intention-to-treat analyses showing beneficial developments of statistical significance (ie, quantity of alcohol use, quantity of tobacco use, and perceived stress; P<.05) and another three outcomes (ie, problem drinking prevalence, cannabis use days, and social skills) showing beneficial developments of borderline significance (P<.10). Conclusions: The results showed good acceptance of this intervention program that could be easily and economically implemented in school classes. Initial results on program efficacy indicate that it might be effective in both preventing or reducing substance use and fostering life skills; however, data from the final 18-month follow-up assessments will be more conclusive. Trial Registration: ISRCTN Registry ISRCTN41347061; https://doi.org/10.1186/ISRCTN41347061 %M 34255703 %R 10.2196/26951 %U https://mhealth.jmir.org/2021/7/e26951 %U https://doi.org/10.2196/26951 %U http://www.ncbi.nlm.nih.gov/pubmed/34255703 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 7 %P e26498 %T A Mobile-Based Intervention to Increase Self-esteem in Students With Depressive Symptoms: Randomized Controlled Trial %A Bruhns,Alina %A Lüdtke,Thies %A Moritz,Steffen %A Bücker,Lara %+ University Medical Center Hamburg-Eppendorf (UKE), Martinistraße 52, Hamburg, 20251, Germany, 49 40741055868, l.buecker@uke.de %K mHealth %K depression %K depressive symptoms %K students’ mental health %K self-help smartphone app %K mobile phone %K self-esteem %D 2021 %7 12.7.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Depressive symptoms are one of the most common and ever-increasing mental health problems among students worldwide. Conventional treatment options, particularly psychotherapy, do not reach all students in need of help. Internet- and mobile-based interventions are promising alternatives for narrowing the treatment gap. Objective: In the framework of a randomized controlled trial, we aim to investigate the effectiveness, acceptance, and side effects of a self-help smartphone app (MCT & More) based on cognitive behavioral therapy, mindfulness, acceptance and commitment therapy, and metacognitive training in a sample of students with self-reported depressive symptoms. Furthermore, we were interested in examining the influence of treatment expectations and attitudes toward internet- and mobile-based interventions on treatment adherence and effectiveness. Methods: A total of 400 students were recruited via open access websites and randomized to either the intervention group (n=200), who received access to the self-help smartphone app MCT & More for a period of 4 weeks, or to a wait-list control group (n=200). The Patient Health Questionnaire-9 (depression) served as the primary outcome parameter, and the Rosenberg Self-esteem Scale (self-esteem) and the global item of the World Health Organization Quality of Life-abbreviated version (quality of life) served as the secondary outcome parameters. The Attitudes Towards Psychological Online Interventions was used to measure attitudes toward internet- and mobile-based interventions. Outcome expectations were assessed using the Patient Questionnaire on Therapy Expectation and Evaluation, and side effects were assessed using the Inventory for Assessing Negative Effects of Psychotherapy. Results: Per-protocol (PP), complete-case, and intention-to-treat analyses showed a significantly higher reduction in depressive symptoms (PP: F1,222=3.98; P=.047; d=0.26) and a significantly higher increase in self-esteem (PP: F1,220=8.79; P=.003; d=0.40) in the intervention group than in the wait-list control group. Most participants regularly used the self-help smartphone app (91/120, 75.8%, at least once a week). The more positive the attitude toward internet- and mobile-based interventions (r=0.260; P=.004) and the more positive the outcome expectation (r=0.236; P=.009), the more frequently the self-help smartphone app was used. Conclusions: The effectiveness of the self-help smartphone app MCT & More was demonstrated among students with depressive symptoms compared with a wait-list control group. The app could be offered regularly as a low-threshold intervention to enhance students’ health. Trial Registration: German Clinical Trials Register DRKS00020941; https://tinyurl.com/pr84w6er %M 34255711 %R 10.2196/26498 %U https://mhealth.jmir.org/2021/7/e26498 %U https://doi.org/10.2196/26498 %U http://www.ncbi.nlm.nih.gov/pubmed/34255711 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e24278 %T Experience Sampling and Programmed Intervention Method and System for Planning, Authoring, and Deploying Mobile Health Interventions: Design and Case Reports %A Cunha,Bruna Carolina Rodrigues %A Rodrigues,Kamila Rios Da Hora %A Zaine,Isabela %A da Silva,Elias Adriano Nogueira %A Viel,Caio César %A Pimentel,Maria Da Graça Campos %+ Federal Institute of Education, Science and Technology of São Paulo, Avenida Doutor Ênio Pires de Camargo, 2971, Capivari, 13360-000, Brazil, 55 1921466700, bruna.rodrigues@ifsp.edu.br %K mobile apps %K mHealth %K intervention %K experience sampling %K method %K monitoring %K Experience Sampling and Programmed Intervention Method %K experience sampling method %K ecological momentary assessment %K just-in-time adaptive intervention %D 2021 %7 12.7.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Health professionals initiating mobile health (mHealth) interventions may choose to adapt apps designed for other activities (eg, peer-to-peer communication) or to employ purpose-built apps specialized in the required intervention, or to exploit apps based on methods such as the experience sampling method (ESM). An alternative approach for professionals would be to create their own apps. While ESM-based methods offer important guidance, current systems do not expose their design at a level that promotes replicating, specializing, or extending their contributions. Thus, a twofold solution is required: a method that directs specialists in planning intervention programs themselves, and a model that guides specialists in adopting existing solutions and advises software developers on building new ones. Objective: The main objectives of this study are to design the Experience Sampling and Programmed Intervention Method (ESPIM), formulated toward supporting specialists in deploying mHealth interventions, and the ESPIM model, which guides health specialists in adopting existing solutions and advises software developers on how to build new ones. Another goal is to conceive and implement a software platform allowing specialists to be users who actually plan, create, and deploy interventions (ESPIM system). Methods: We conducted the design and evaluation of the ESPIM method and model alongside a software system comprising integrated web and mobile apps. A participatory design approach with stakeholders included early software prototype, predesign interviews with 12 health specialists, iterative design sustained by the software as an instance of the method’s conceptual model, support to 8 real case studies, and postdesign interviews. Results: The ESPIM comprises (1) a list of requirements for mHealth experience sampling and intervention-based methods and systems, (2) a 4-dimension planning framework, (3) a 7-step-based process, and (4) an ontology-based conceptual model. The ESPIM system encompasses web and mobile apps. Eight long-term case studies, involving professionals in psychology, gerontology, computer science, speech therapy, and occupational therapy, show that the method allowed specialists to be actual users who plan, create, and deploy interventions via the associated system. Specialists’ target users were parents of children diagnosed with autism spectrum disorder, older persons, graduate and undergraduate students, children (age 8-12), and caregivers of older persons. The specialists reported being able to create and conduct their own studies without modifying their original design. A qualitative evaluation of the ontology-based conceptual model showed its compliance to the functional requirements elicited. Conclusions: The ESPIM method succeeds in supporting specialists in planning, authoring, and deploying mobile-based intervention programs when employed via a software system designed and implemented according to its conceptual model. The ESPIM ontology–based conceptual model exposes the design of systems involving active or passive sampling interventions. Such exposure supports the evaluation, implementation, adaptation, or extension of new or existing systems. %M 34255652 %R 10.2196/24278 %U https://www.jmir.org/2021/7/e24278 %U https://doi.org/10.2196/24278 %U http://www.ncbi.nlm.nih.gov/pubmed/34255652 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e23959 %T Recruitment and Retention Strategies Among Racial and Ethnic Minorities in Web-Based Intervention Trials: Retrospective Qualitative Analysis %A Hwang,DaSol Amy %A Lee,Alex %A Song,Jae Min %A Han,Hae-Ra %+ Johns Hopkins University School of Nursing, 525 N Wolfe St, Room 533, Baltimore, MD, 21205, United States, 1 410 614 2669, hhan3@jh.edu %K recruitment and retention %K web-based intervention %K clinical trial %K Korean American %K racial/ethnic minority %D 2021 %7 12.7.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Racial and ethnic minority groups are underrepresented in health research, contributing to persistent health disparities in the United States. Identifying effective recruitment and retention strategies among minority groups and their subpopulations is an important research agenda. Web-based intervention approaches are becoming increasingly popular with the ubiquitous use of the internet. However, it is not completely clear which recruitment and retention strategies have been successful in web-based intervention trials targeting racial and ethnic minorities. Objective: This study aims to describe lessons learned in recruiting and retaining one of the understudied ethnic minority women—Korean Americans—enrolled in a web-based intervention trial and to compare our findings with the strategies reported in relevant published web-based intervention trials. Methods: Multiple sources of data were used to address the objectives of this study, including the study team’s meeting minutes, participant tracking and contact logs, survey reports, and postintervention interviews. In addition, an electronic search involving 2 databases (PubMed and CINAHL) was performed to identify published studies using web-based interventions. Qualitative analysis was then performed to identify common themes addressing recruitment and retention strategies across the trials using web-based intervention modalities. Results: A total of 9 categories of recruitment and retention strategies emerged: authentic care; accommodation of time, place, and transportation; financial incentives; diversity among the study team; multiple, yet standardized modes of communication; mobilizing existing community relationships with efforts to build trust; prioritizing features of web-based intervention; combined use of web-based and direct recruitment; and self-directed web-based intervention with human support. Although all the studies included in the analysis combined multiple strategies, prioritizing features of web-based intervention or use of human support were particularly relevant for promoting recruitment and retention of racial and ethnic minorities in web-based intervention trials. Conclusions: The growing prevalence of internet use among racial and ethnic minority populations represents an excellent opportunity to design and deliver intervention programs via the internet. Future research should explore and compare successful recruitment and retention methods among race and ethnic groups for web-based interventions. Trial Registration: ClinicalTrials.gov NCT03726619; https://clinicaltrials.gov/ct2/show/NCT03726619. %M 34255658 %R 10.2196/23959 %U https://www.jmir.org/2021/7/e23959 %U https://doi.org/10.2196/23959 %U http://www.ncbi.nlm.nih.gov/pubmed/34255658 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 7 %P e25285 %T A Web-Based Social Network Tool (GENIE) for Supporting Self-management Among High Users of the Health Care System: Feasibility and Usability Study %A Valaitis,Ruta %A Cleghorn,Laura %A Vassilev,Ivaylo %A Rogers,Anne %A Ploeg,Jenny %A Kothari,Anita %A Risdon,Cathy %A Gillett,James %A Guenter,Dale %A Dolovich,Lisa %+ School of Nursing, McMaster University, 128 Main Street West, Hamilton, ON, L8S 4K1, Canada, 1 9055772022, valaitis@mcmaster.ca %K web-based tool %K usability %K feasibility %K self-management %K social network %K primary care %K health and social services %K linkages %K high systems users %K volunteers %D 2021 %7 12.7.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Primary care providers are well positioned to foster self-management through linking patients to community-based health and social services (HSSs). This study evaluated a web-based tool—GENIE (Generating Engagement in Network Involvement)—to support the self-management of adults. GENIE empowers patients to leverage their personal social networks and increase their access to HSSs. GENIE maps patients’ personal social networks, elicits preferences, and filters local HSSs from a community service directory based on patient’s interests. Trained volunteers (an extension of the primary care team) conducted home visits and conducted surveys related to life and health goals in the context of the Health TAPESTRY (Teams Advancing Patient Experience: Strengthening Quality) program, in which the GENIE tool was implemented. GENIE reports were uploaded to an electronic medical record for care planning by the team. Objective: This study aims to explore patients’, volunteers’, and clinicians’ perceptions of the feasibility, usability, and perceived outcomes of GENIE—a tool for community-dwelling adults who are high users of the health care system. Methods: This study involved 2 primary care clinician focus groups and 1 clinician interview (n=15), 1 volunteer focus group (n=3), patient telephone interviews (n=8), field observations that captured goal-action sequences to complete GENIE, and GENIE utilization statistics. The patients were enrolled in a primary care program—Health TAPESTRY—and Ontario’s Health Links Program, which coordinates care for the highest users of the health care system. NVivo 11 (QSR International) was used to support qualitative data analyses related to feasibility and perceived outcomes, and descriptive statistics were used for quantitative data. Results: Most participants reported positive overall perceptions of GENIE. However, feasibility testing showed that participants had a partial understanding of the tool; volunteer facilitation was critical to support the implementation of GENIE; clinicians perceived their navigation ability as superior to that of GENIE supported by volunteers; and tool completion took 39 minutes, which made the home visit too long for some. Usability challenges included difficulties completing some sections of the tool related to medical terminology and unclear instructions, limitations in the quality and quantity of HSSs results, and minor technological challenges. Almost all patients identified a community program or activity of interest. Half of the patients (4/8, 50%) followed up on HSSs and added new members to their network, whereas 1 participant lost a member. Clinicians’ strengthened their understanding of patients’ personal social networks and needs, and patients felt less social isolation. Conclusions: This study demonstrated the potential of GENIE, when supported by volunteers, to expand patients’ social networks and link them to relevant HSSs. Volunteers require training to implement GENIE for self-management support, which may help overcome the time limitations faced by primary care clinicians. Refining the filtering capability of GENIE to address adults’ needs may improve primary care providers’ confidence in using such tools. %M 34255654 %R 10.2196/25285 %U https://formative.jmir.org/2021/7/e25285 %U https://doi.org/10.2196/25285 %U http://www.ncbi.nlm.nih.gov/pubmed/34255654 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 3 %P e28309 %T Evaluation of Web-Based and In-Person Methods to Recruit Adults With Type 1 Diabetes for a Mobile Exercise Intervention: Prospective Observational Study %A Ash,Garrett I %A Griggs,Stephanie %A Nally,Laura M %A Stults-Kolehmainen,Matthew %A Jeon,Sangchoon %A Brandt,Cynthia %A Gulanski,Barbara I %A Spanakis,Elias K %A Baker,Julien S %A Whittemore,Robin %A Weinzimer,Stuart A %A Fucito,Lisa M %+ Pain, Research, Informatics, Medical Comorbidities and Education Center, Veterans Affairs Connecticut Healthcare System, 11-ACSLG, Building 35A, Rm 235, 950 Campbell Ave, West Haven, CT, 06516, United States, 1 2034443079, garrett.ash@yale.edu %K type 1 diabetes mellitus %K exercise %K behavior and behavior mechanisms %K mobile phone %D 2021 %7 8.7.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Our clinical trial of a mobile exercise intervention for adults 18 to 65 years old with type 1 diabetes (T1D) occurred during COVID-19 social distancing restrictions, prompting us to test web-based recruitment methods previously underexplored for this demographic. Objective: Our objectives for this study were to (1) evaluate the effectiveness and cost of using social media news feed advertisements, a clinic-based approach method, and web-based snowball sampling to reach inadequately active adults with T1D and (2) compare characteristics of enrollees against normative data. Methods: Participants were recruited between November 2019 and August 2020. In method #1, Facebook and Instagram news feed advertisements ran for five 1-to-8-day windows targeting adults (18 to 64 years old) in the greater New Haven and Hartford, Connecticut, areas with one or more diabetes-related profile interest. If interested, participants completed a webform so that the research team could contact them for eligibility screening. In method #2, patients 18 to 24 years old with T1D were approached in person at clinical visits in November and December 2019. Those who were interested immediately completed eligibility screening. Older patients could not be approached due to clinic restrictions. In method #3, snowball sampling was conducted by physically active individuals with T1D contacting their peers on Facebook and via email for 48 days, with details to contact the research staff to express interest and complete eligibility screening. Other methods referred participants to the study similarly to snowball sampling. Results: In method #1, advertisements were displayed to 11,738 unique viewers and attracted 274 clickers (2.33%); 20 participants from this group (7.3%) volunteered, of whom 8 (40%) were eligible. Costs averaged US $1.20 per click and US $95.88 per eligible volunteer. Men had lower click rates than women (1.71% vs 3.17%; P<.001), but their responsiveness and eligibility rates did not differ. In method #2, we approached 40 patients; 32 of these patients (80%) inquired about the study, of whom 20 (63%) volunteered, and 2 of these volunteers (10%) were eligible. Costs including personnel for in-person approaches averaged US $21.01 per inquirer and US $479.79 per eligible volunteer. In method #3, snowball sampling generated 13 inquirers; 12 of these inquirers (92%) volunteered, of whom 8 (67%) were eligible. Incremental costs to attract inquirers were negligible, and total costs averaged US $20.59 per eligible volunteer. Other methods yielded 7 inquirers; 5 of these inquirers (71%) volunteered, of whom 2 (40%) were eligible. Incremental costs to attract inquirers were negligible, and total costs averaged US $34.94 per eligible volunteer. Demographic overrepresentations emerged in the overall cohort (ie, optimal glycemic control, obesity, and low exercise), among those recruited by news feed advertisements (ie, obesity and older age), and among those recruited by snowball sampling (ie, optimal glycemic control and low exercise). Conclusions: Web-based advertising and recruitment strategies are a promising means to attract adults with T1D to clinical trials and exercise interventions, with costs comparing favorably to prior trials despite targeting an uncommon condition (ie, T1D) and commitment to an intervention. These strategies should be tailored in future studies to increase access to higher-risk participants. Trial Registration: ClinicalTrials.gov NCT04204733; https://clinicaltrials.gov/ct2/show/NCT04204733 %M 34047700 %R 10.2196/28309 %U https://diabetes.jmir.org/2021/3/e28309 %U https://doi.org/10.2196/28309 %U http://www.ncbi.nlm.nih.gov/pubmed/34047700 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 7 %P e28667 %T A Web-Based Cognitive Bias Modification Intervention (Re-train Your Brain) for Emerging Adults With Co-occurring Social Anxiety and Hazardous Alcohol Use: Protocol for a Multiarm Randomized Controlled Pilot Trial %A Prior,Katrina %A Salemink,Elske %A Wiers,Reinout W %A Teachman,Bethany A %A Piggott,Monique %A Newton,Nicola C %A Teesson,Maree %A Baillie,Andrew J %A Manning,Victoria %A McLellan,Lauren F %A Mahoney,Alison %A Stapinski,Lexine A %+ The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Level 6, Jane Foss Russell building (G02), Sydney, 2006, Australia, 61 02 8627 9032, katrina.prior@sydney.edu.au %K alcohol %K anxiety %K cognitive bias modification %K interpretation bias %K approach bias %K emerging adults %D 2021 %7 7.7.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Alcohol use and anxiety disorders commonly co-occur, resulting in a more severe clinical presentation and poorer response to treatment. Research has shown that approach bias modification (ApBM) and interpretation bias modification (IBM) cognitive retraining interventions can be efficacious adjunctive treatments that improve outcomes for alcohol use and social anxiety, respectively. However, the acceptability, feasibility, and clinical utility of combining ApBM and IBM programs to optimize treatments among comorbid samples are unknown. It is also unclear whether integrating ApBM and IBM within each training session or alternating them between each session is more acceptable and efficacious. Objective: This paper describes the protocol for a randomized controlled pilot trial investigating the feasibility, acceptability, and preliminary efficacy of the Re-train Your Brain intervention—an adjunct web-based ApBM+IBM program—among a clinical sample of emerging adults with hazardous alcohol use and social anxiety. Methods: The study involves a three-arm randomized controlled pilot trial in which treatment-seeking emerging adults (18-30 years) with co-occurring hazardous alcohol use and social anxiety will be individually randomized to receive the Re-train Your Brain integrated program, delivered with 10 biweekly sessions focusing on both social anxiety and alcohol each week, plus treatment as usual (TAU; ie, the model of care provided in accordance with standard practice at their service; n=30); the Re-train Your Brain alternating program, delivered with 10 biweekly sessions focusing on social anxiety one week and alcohol the next week, plus TAU (n=30); or TAU only (n=30). Primary outcomes include feasibility (uptake, follow-up rates, treatment adherence, attrition, and adverse events) and acceptability (system usability, client satisfaction, user experience, and training format preference). Secondary efficacy outcomes include changes in alcohol approach and interpretation biases, social anxiety, and alcohol use (eg, drinks per day, binge drinking, drinking motives, severity of dependence, and cravings). The primary end point will be posttreatment (6 weeks postbaseline), with a secondary end point at 3 months postbaseline. Descriptive statistics will be conducted for primary outcomes, whereas intention-to-treat, multilevel mixed effects analysis for repeated measures will be performed for secondary outcomes. Results: This study is funded from 2019 to 2023 by Australian Rotary Health. Recruitment is expected to be completed by mid-2022 to late 2022, with follow-ups completed by early 2023. Conclusions: This study will be the first to evaluate whether an ApBM+IBM program is acceptable to treatment-seeking, emerging adults and whether it can be feasibly delivered via the web, in settings where it will ultimately be used (eg, at home). The findings will broaden our understanding of the types of programs that emerging adults will engage with and whether the program may be an efficacious treatment option for this comorbidity. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620001273976; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364131 International Registered Report Identifier (IRRID): PRR1-10.2196/28667 %M 34255726 %R 10.2196/28667 %U https://www.researchprotocols.org/2021/7/e28667 %U https://doi.org/10.2196/28667 %U http://www.ncbi.nlm.nih.gov/pubmed/34255726 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e26704 %T Efficacy of a Just-in-Time Adaptive Intervention to Promote HIV Risk Reduction Behaviors Among Young Adults Experiencing Homelessness: Pilot Randomized Controlled Trial %A Santa Maria,Diane %A Padhye,Nikhil %A Businelle,Michael %A Yang,Yijiong %A Jones,Jennifer %A Sims,Alexis %A Lightfoot,Marguerita %+ Cizik School of Nursing, University of Texas Health Science Center at Houston, 6901 Bertner Ave, Houston, TX, 77030, United States, 1 713 500 2190, diane.m.santamaria@uth.tmc.edu %K youth %K homelessness %K HIV %K prevention %K just-in-time adaptive interventions %K mHealth %K ecological momentary assessments %K drug use %K stress %K intervention %K smartphone %K mobile phone %K drug %K efficacy %K pilot %K feasibility %K predictor %K risk %K behavior %D 2021 %7 6.7.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: People experiencing homelessness have higher rates of HIV than those who are stably housed. Mental health needs, substance use problems, and issues unique to homelessness such as lack of shelter and transiency need to be considered with regard to HIV prevention. To date, HIV prevention interventions for young adults experiencing homelessness have not specifically addressed modifiable real-time factors such as stress, sexual or drug use urge, or substance use, or been delivered at the time of heightened risk. Real-time, personalized HIV prevention messages may reduce HIV risk behaviors. Objective: This pilot study tested the initial efficacy of an innovative, smartphone-based, just-in-time adaptive intervention that assessed predictors of HIV risk behaviors in real time and automatically provided behavioral feedback and goal attainment information. Methods: A randomized attention control design was used among young adults experiencing homelessness, aged 18-25 years, recruited from shelters and drop-in centers in May 2019. Participants were randomized to either a control or an intervention group. The intervention (called MY-RID [Motivating Youth to Reduce Infection and Disconnection]) consisted of brief messages delivered via smartphone over 6 weeks in response to preidentified predictors that were assessed using ecological momentary assessments. Bayesian hierarchical regression models were used to assess intervention effects on sexual activity, drug use, alcohol use, and their corresponding urges. Results: Participants (N=97) were predominantly youth (mean age 21.2, SD 2.1 years) who identified as heterosexual (n=51, 52%), male (n=56, 57%), and African American (n=56, 57%). Reports of sexual activity, drug use, alcohol use, stress, and all urges (ie, sexual, drug, alcohol) reduced over time in both groups. Daily drug use reduced by a factor of 13.8 times over 6 weeks in the intervention group relative to the control group (Multimedia Appendix 4). Lower urges for sex were found in the intervention group relative to the control group over the duration of the study. Finally, there was a statistically significant reduction in reports of feeling stressed the day before between the intervention and control conditions (P=.03). Conclusions: Findings indicate promising intervention effects on drug use, stress, and urges for sex in a hard-to-reach, high-risk population. The MY-RID intervention should be further tested in a larger randomized controlled trial to further investigate its efficacy and impact on sexual risk behaviors. Trial Registration: ClinicalTrials.gov NCT03911024; https://clinicaltrials.gov/ct2/show/NCT03911024 %M 34255679 %R 10.2196/26704 %U https://www.jmir.org/2021/7/e26704 %U https://doi.org/10.2196/26704 %U http://www.ncbi.nlm.nih.gov/pubmed/34255679 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 7 %P e29538 %T Empowering Anxious Parents to Manage Child Avoidance Behaviors: Randomized Control Trial of a Single-Session Intervention for Parental Accommodation %A Sung,Jenna Y %A Mumper,Emma %A Schleider,Jessica Lee %+ Department of Psychology, Stony Brook University, Psychology-B 340, Stony Brook, NY, 11794-2500, United States, 1 631 632 4131, jessica.schleider@stonybrook.edu %K acceptability %K adolescent mental health %K adolescent %K anxiety %K avoidance %K behavior %K child mental health %K children %K digital mental health %K intervention %K mental health %K parent %K prevention %K young adult %D 2021 %7 6.7.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: A majority of youth who need anxiety treatment never access support. This disparity reflects a need for more accessible, scalable interventions—particularly those that may prevent anxiety in high-risk children, mitigating future need for higher-intensity care. Self-guided single-session interventions (SSIs) may offer a promising path toward this goal, given their demonstrated clinical utility, potential for disseminability, and low cost. However, existing self-guided SSIs have been designed for completion by adolescents already experiencing symptoms, and their potential for preventing anxiety in children—for instance, by mitigating known anxiety risk factors—remains unexplored. Objective: This trial evaluated the acceptability and proximal effects of project EMPOWER: a web-based, self-guided SSI designed to reduce parental accommodation, a parenting behavior known to increase the risk of anxiety in offspring. Methods: In total, 301 parents who reported elevated anxiety symptoms with children aged 4-10 years received either project EMPOWER or an informational control (containing psychoeducational materials and resources); parents self-reported their accommodation of child anxiety and overall distress tolerance at baseline and 2-week follow-up. Results: Relative to control-group parents, those who received the intervention outlined in project EMPOWER reported significant reductions in their accommodation of child anxiety (ds=0.61; P<.001) and significant increases in their distress tolerance (ds=0.43; P<.001) from baseline to 2-week follow-up. Additionally, parents rated project EMPOWER as highly acceptable (ie, easy to use, helpful, and engaging) in accordance with preregistered benchmarks. Conclusions: Project EMPOWER is an acceptable self-guided SSI for parents of children at-risk for anxiety, which yields proximal reductions in clinically relevant targets. Trial Registration: ClinicalTrials.gov NCT04453865; https://tinyurl.com/4h84j8t9 %M 34255718 %R 10.2196/29538 %U https://mental.jmir.org/2021/7/e29538 %U https://doi.org/10.2196/29538 %U http://www.ncbi.nlm.nih.gov/pubmed/34255718 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e25850 %T Studying Microtemporal, Within-Person Processes of Diet, Physical Activity, and Related Factors Using the APPetite-Mobile-App: Feasibility, Usability, and Validation Study %A Ruf,Alea %A Koch,Elena Doris %A Ebner-Priemer,Ulrich %A Knopf,Monika %A Reif,Andreas %A Matura,Silke %+ Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe University, Heinrich-Hoffmann-Straße 10, Frankfurt, 60528, Germany, 49 69 6301 83348, alea.ruf@kgu.de %K diet %K physical activity %K microtemporal processes %K within-person factors %K ecological momentary assessment %K smartphone-app %K mobile phone %K mHealth %K dietary assessment %K feasibility %K usability %K validity %D 2021 %7 5.7.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Diet and physical activity (PA) have a major impact on physical and mental health. However, there is a lack of effective strategies for sustaining these health-protective behaviors. A shift to a microtemporal, within-person approach is needed to capture dynamic processes underlying eating behavior and PA, as they change rapidly across minutes or hours and differ among individuals. However, a tool that captures these microtemporal, within-person processes in daily life is currently not present. Objective: The APPetite-mobile-app is developed for the ecological momentary assessment of microtemporal, within-person processes of complex dietary intake, objectively recorded PA, and related factors. This study aims to evaluate the feasibility and usability of the APPetite-mobile-app and the validity of the incorporated APPetite-food record. Methods: The APPetite-mobile-app captures dietary intake event-contingently through a food record, captures PA continuously through accelerometers, and captures related factors (eg, stress) signal-contingently through 8 prompts per day. Empirical data on feasibility (n=157), usability (n=84), and validity (n=44) were collected within the Eat2beNICE-APPetite-study. Feasibility and usability were examined in healthy participants and psychiatric patients. The relative validity of the APPetite-food record was assessed with a subgroup of healthy participants by using a counterbalanced crossover design. The reference method was a 24-hour recall. In addition, the energy intake was compared with the total energy expenditure estimated from accelerometry. Results: Good feasibility, with compliance rates above 80% for prompts and the accelerometer, as well as reasonable average response and recording durations (prompt: 2.04 min; food record per day: 17.66 min) and latencies (prompts: 3.16 min; food record: 58.35 min) were found. Usability was rated as moderate, with a score of 61.9 of 100 on the System Usability Scale. The evaluation of validity identified large differences in energy and macronutrient intake between the two methods at the group and individual levels. The APPetite-food record captured higher dietary intakes, indicating a lower level of underreporting, compared with the 24-hour recall. Energy intake was assessed fairly accurately by the APPetite-food record at the group level on 2 of 3 days when compared with total energy expenditure. The comparison with mean total energy expenditure (2417.8 kcal, SD 410) showed that the 24-hour recall (1909.2 kcal, SD 478.8) underestimated habitual energy intake to a larger degree than the APPetite-food record (2146.4 kcal, SD 574.5). Conclusions: The APPetite-mobile-app is a promising tool for capturing microtemporal, within-person processes of diet, PA, and related factors in real time or near real time and is, to the best of our knowledge, the first of its kind. First evidence supports the good feasibility and moderate usability of the APPetite-mobile-app and the validity of the APPetite-food record. Future findings in this context will build the foundation for the development of personalized lifestyle modification interventions, such as just-in-time adaptive interventions. %M 34342268 %R 10.2196/25850 %U https://www.jmir.org/2021/7/e25850 %U https://doi.org/10.2196/25850 %U http://www.ncbi.nlm.nih.gov/pubmed/34342268 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 7 %P e27774 %T Time to Change for Mental Health and Well-being via Virtual Professional Coaching: Longitudinal Observational Study %A Jeannotte,Alexis M %A Hutchinson,Derek M %A Kellerman,Gabriella R %+ BetterUp, Inc, 1200 Folsom Street, San Francisco, CA, 94103, United States, 1 7034022166, ajeannotte28@gmail.com %K professional coaching %K virtual coaching %K mental health %K psychological well-being %K stress %K resilience %K life satisfaction %K longitudinal %K intervention %K well-being %K satisfaction %K coach %K observational %D 2021 %7 5.7.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Optimal mental health yields many benefits and reduced costs to employees and organizations; however, the workplace introduces challenges to building and maintaining mental health that affect well-being. Although many organizations have introduced programming to aid employee mental health and well-being, the uptake and effectiveness of these efforts vary. One barrier to developing more effective interventions is a lack of understanding about how to improve well-being over time. This study examined not only whether employer-provided coaching is an effective strategy to improve mental health and well-being in employees but also how this intervention changes well-being in stages over time. Objective: The goal of this study was to determine whether BetterUp, a longitudinal one-on-one virtual coaching intervention, improves components of mental health and psychological well-being, and whether the magnitude of changes vary in stages over time. This is the first research study to evaluate the effectiveness of professional coaching through three repeated assessments, moving beyond a pre-post intervention design. The outcomes of this study will enable coaches and employers to design more targeted interventions by outlining when to expect maximal growth in specific outcomes throughout the coaching engagement. Methods: Three identical assessments were completed by 391 users of BetterUp: prior to the start of coaching, after approximately 3-4 months of coaching, and again after 6-7 months of coaching. Three scales were used to evaluate psychological and behavioral dimensions that support management of mental health: stress management, resilience, and life satisfaction. Six additional scales were used to assess psychological well-being: emotional regulation, prospection ability, finding purpose and meaning, self-awareness, self-efficacy, and social connection. Results: Using mixed-effects modeling, varying rates of change were observed in several dimensions of mental health and psychological well-being. Initial rapid improvements in the first half of the intervention, followed by slower growth in the second half of the intervention were found for prospection ability, self-awareness, self-efficacy, social connection, emotional regulation, and a reduction in stress (range of unstandardized β values for each assessment: .10-.19). Life satisfaction improved continuously throughout the full intervention period (β=.13). Finding purpose in meaning at work and building resilience both grew continuously throughout the coaching intervention, but larger gains were experienced in the second half of the intervention (β=.08-.18), requiring the full length of the intervention to realize maximal growth. Conclusions: The results demonstrate the effectiveness of BetterUp virtual one-on-one coaching to improve psychological well-being, while mitigating threats to mental health such as excessive and prolonged stress, low resilience, and poor satisfaction with life. The improvements across the collection of outcomes were time-dependent, and provide important insights to users and practitioners about how and when to expect maximal improvements in a range of interrelated personal and professional outcomes. %M 33993102 %R 10.2196/27774 %U https://www.jmir.org/2021/7/e27774 %U https://doi.org/10.2196/27774 %U http://www.ncbi.nlm.nih.gov/pubmed/33993102 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 7 %P e24915 %T Examining the Impact of an mHealth Behavior Change Intervention With a Brief In-Person Component for Cancer Survivors With Overweight or Obesity: Randomized Controlled Trial %A Walsh,Jane C %A Richmond,Janice %A Mc Sharry,Jenny %A Groarke,AnnMarie %A Glynn,Liam %A Kelly,Mary Grace %A Harney,Owen %A Groarke,Jenny M %+ Centre for Improving Health-Related Quality of Life, School of Psychology, Queen's University Belfast, David Keir Building, Belfast, BT7 1NN, United Kingdom, 44 02890974886, j.groarke@qub.ac.uk %K cancer survivors %K overweight %K obesity %K health behavior %K goals %K accelerometry %K text messaging %K technology %K Ireland %K self-management %K mobile phone %D 2021 %7 5.7.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Cancer survivorship in Ireland is increasing in both frequency and longevity. However, a significant proportion of cancer survivors do not reach the recommended physical activity levels and have overweight. This has implications for both physical and psychological health, including an increased risk of subsequent and secondary cancers. Mobile health (mHealth) interventions demonstrate potential for positive health behavior change, but there is little evidence for the efficacy of mobile technology in improving health outcomes in cancer survivors with overweight or obesity. Objective: This study aims to investigate whether a personalized mHealth behavior change intervention improves physical and psychological health outcomes in cancer survivors with overweight or obesity. Methods: A sample of 123 cancer survivors (BMI≥25 kg/m2) was randomly assigned to the standard care control (n=61) or intervention (n=62) condition. Group allocation was unblinded. The intervention group attended a 4-hour tailored lifestyle education and information session with physiotherapists, a dietician, and a clinical psychologist to support self-management of health behavior. Over the following 12 weeks, participants engaged in personalized goal setting to incrementally increase physical activity (with feedback and review of goals through SMS text messaging contact with the research team). Direct measures of physical activity were collected using a Fitbit accelerometer. Data on anthropometric, functional exercise capacity, dietary behavior, and psychological measures were collected at face-to-face assessments in a single hospital site at baseline (T0), 12 weeks (T1; intervention end), and 24 weeks (T2; follow-up). Results: The rate of attrition was 21% (13/61) for the control condition and 14% (9/62) for the intervention condition. Using intent-to-treat analysis, significant reductions in BMI (F2,242=4.149; P=.02; ηp2=0.033) and waist circumference (F2,242=3.342; P=.04; ηp2=0.027) were observed in the intervention group. Over the 24-week study, BMI was reduced by 0.52 in the intervention condition, relative to a nonsignificant reduction of 0.11 in the control arm. Waist circumference was reduced by 3.02 cm in the intervention condition relative to 1.82 cm in the control condition. Physical activity level was significantly higher in the intervention group on 8 of the 12 weeks of the intervention phase and on 5 of the 12 weeks of the follow-up period, accounting for up to 2500 additional steps per day (mean 2032, SD 270). Conclusions: The results demonstrate that for cancer survivors with a BMI≥25 kg/m2, lifestyle education and personalized goal setting using mobile technology can yield significant changes in clinically relevant health indicators. Further research is needed to elucidate the mechanisms of behavior change and explore the capacity for mHealth interventions to improve broader health and well-being outcomes in the growing population of cancer survivors. Trial Registration: ISRCTN Registry ISRCTN18676721; https://www.isrctn.com/ISRCTN18676721 International Registered Report Identifier (IRRID): RR2-10.2196/13214 %M 36260394 %R 10.2196/24915 %U https://mhealth.jmir.org/2021/7/e24915 %U https://doi.org/10.2196/24915 %U http://www.ncbi.nlm.nih.gov/pubmed/36260394 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 6 %P e28952 %T A Web-Based Intervention to Increase Smokers’ Intentions to Participate in a Cessation Study Offered at the Point of Lung Screening: Factorial Randomized Trial %A Neil,Jordan M %A Chang,Yuchiao %A Goshe,Brett %A Rigotti,Nancy %A Gonzalez,Irina %A Hawari,Saif %A Ballini,Lauren %A Haas,Jennifer S %A Marotta,Caylin %A Wint,Amy %A Harris,Kim %A Crute,Sydney %A Flores,Efren %A Park,Elyse R %+ Health Promotion Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, 655 Research Parkway, 1404, Oklahoma City, OK, 73104, United States, 1 6034430743, jordan-neil@ouhsc.edu %K clinical trials recruitment %K digital outreach %K message design experiment %K smoking cessation %K lung cancer screening %K prospect theory %D 2021 %7 30.6.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Screen ASSIST is a cessation trial offered to current smokers at the point of lung cancer screening. Because of the unique position of promoting a prevention behavior (smoking cessation) within the context of a detection behavior (lung cancer screening), this study employed prospect theory to design and formatively evaluate a targeted recruitment video prior to trial launch. Objective: The aim of this study was to identify which message frames were most effective at promoting intent to participate in a smoking cessation study. Methods: Participants were recruited from a proprietary opt-in online panel company and randomized to a 2 (benefits of quitting vs risks of continuing to smoke at the time of lung screening; BvR) × 2 (gains of participating vs losses of not participating in a cessation study; GvL) message design experiment (N=314). The primary outcome was self-assessed intent to participate in a smoking cessation study. Message effectiveness and lung cancer risk perception measures were also collected. Analysis of variance examined the main effect of the 2 message factors and a least absolute shrinkage and selection operator (LASSO) approach identified predictors of intent to participate in a multivariable model. A mediation analysis was conducted to determine the direct and indirect effects of message factors on intent to participate in a cessation study. Results: A total of 296 participants completed the intervention. There were no significant differences in intent to participate in a smoking cessation study between message frames (P=.12 and P=.61). In the multivariable model, quit importance (P<.001), perceived message relevance (P<.001), and affective risk response (ie, worry about developing lung cancer; P<.001) were significant predictors of intent to participate. The benefits of quitting frame significantly increased affective risk response (Meanbenefits 2.60 vs Meanrisk 2.40; P=.03), which mediated the relationship between message frame and intent to participate (b=0.24; 95% CI 0.01-0.47; P=.03). Conclusions: This study provides theoretical and practical guidance on how to design and evaluate proactive recruitment messages for a cessation trial. Based on our findings, we conclude that heavy smokers are more responsive to recruitment messages that frame the benefits of quitting as it increased affective risk response, which predicted greater intention to participate in a smoking cessation study. %M 34255651 %R 10.2196/28952 %U https://formative.jmir.org/2021/6/e28952 %U https://doi.org/10.2196/28952 %U http://www.ncbi.nlm.nih.gov/pubmed/34255651 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 6 %P e26619 %T The Effectiveness and Usability of Online, Group-Based Interventions for People With Severe Obesity: Protocol for a Systematic Review %A Milne-Ives,Madison %A Swancutt,Dawn %A Burns,Lorna %A Pinkney,Jonathan %A Tarrant,Mark %A Calitri,Raff %A Chatterjee,Arunangsu %A Meinert,Edward %+ Centre for Health Technology, University of Plymouth, 6 Kirkby Place, Plymouth, PL4 6DT, United Kingdom, 44 1752600600, edward.meinert@plymouth.ac.uk %K internet-based interventions %K telemedicine %K group-based interventions %K obesity %K severe obesity %K obesity management %K weight loss %K weight reduction programs %K diet therapy %K exercise %K systematic review %K weight management %D 2021 %7 30.6.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Globally, obesity is a growing crisis. Despite obesity being preventable, over a quarter of the UK adult population is currently considered clinically obese (typically body mass index ≥35 kg/m2). Access to treatment for people with severe obesity is limited by long wait times and local availability. Online and group-based interventions provide means of increasing the accessibility of obesity prevention and treatment services. However, there has been no prior review of the effectiveness of group-based interventions delivered online for people with severe obesity. Objective: The purpose of this systematic review protocol is to provide an evaluation of the effectiveness and usability of different types of online, group-based interventions for people with severe obesity. Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) and the Population, Intervention, Comparator, Outcome, and Study (PICOS) frameworks were used to structure this review. The review will systematically search 7 databases: MEDLINE, Embase, the Cumulative Index of Nursing and Allied Health Literature, APA PsycNet, Web of Science, CENTRAL, and the ProQuest Dissertations and Theses databases. Two authors (MM-I and LB) will independently screen the titles and abstracts of identified articles, select studies for inclusion based on the eligibility criteria, and extract data into a standardized form. Any disagreements will be discussed and resolved by a third reviewer (EM) if necessary. Risk of bias will be assessed using the Cochrane Collaboration Risk of Bias 2 tool and a descriptive analysis will be used to evaluate effectiveness and usability. Results: The systematic review has not yet been started. It is expected to be completed and submitted for publication by December 2021. Conclusions: This systematic review will summarize the effectiveness and usability of online, group-based interventions for people with obesity. It will identify the types of online delivery that have the strongest support to help inform the development of more useful and engaging interventions for people with severe obesity. Trial Registration: National Institute for Health Research, PROSPERO CRD42021227101; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021227101 International Registered Report Identifier (IRRID): PRR1-10.2196/26619 %M 34255710 %R 10.2196/26619 %U https://www.researchprotocols.org/2021/6/e26619 %U https://doi.org/10.2196/26619 %U http://www.ncbi.nlm.nih.gov/pubmed/34255710 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 7 %N 6 %P e23990 %T Development of the Czech Childhood Cancer Information System: Data Analysis and Interactive Visualization %A Krejčí,Denisa %A Karolyi,Matěj %A Pehalová,Lucie %A Ščavnický,Jakub %A Zapletalová,Michaela %A Katinová,Ivana %A Štěrba,Jaroslav %A Starý,Jan %A Šnajdrová,Lenka %A Komenda,Martin %A Dušek,Ladislav %+ Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Kamenice 3, Brno, 62500, Czech Republic, 420 608273417, Denisa.Krejci@uzis.cz %K cancer epidemiology %K children %K data visualization %K software development %D 2021 %7 29.6.2021 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: The knowledge of cancer burden in the population, its time trends, and the possibility of international comparison is an important starting point for cancer programs. A reliable interactive tool describing cancer epidemiology in children and adolescents has been nonexistent in the Czech Republic until recently. Objective: The goal of this study is to develop a new web portal entitled the Czech Childhood Cancer Information System (CCCIS), which would provide information on childhood cancer epidemiology in the Czech Republic. Methods: Data on childhood cancers have been obtained from the Czech National Cancer Registry. These data were validated using the clinical database of childhood cancer patients and subsequently combined with data from the National Register of Hospitalised Patients and with data from death certificates. These validated data were then used to determine the incidence and survival rates of childhood cancer patients aged 0 to 19 years who were diagnosed in the period 1994 to 2016 (N=9435). Data from death certificates were used to monitor long-term mortality trends. The technical solution is based on the robust PHP development Symfony framework, with the PostgreSQL system used to accommodate the data basis. Results: The web portal has been available for anyone since November 2019, providing basic information for experts (ie, analyses and publications) on individual diagnostic groups of childhood cancers. It involves an interactive tool for analytical reporting, which provides information on the following basic topics in the form of graphs or tables: incidence, mortality, and overall survival. Feedback was obtained and the accuracy of outputs published on the CCCIS portal was verified using the following methods: the validation of the theoretical background and the user testing. Conclusions: We developed software capable of processing data from multiple sources, which is freely available to all users and makes it possible to carry out automated analyses even for users without mathematical background; a simple selection of a topic to be analyzed is required from the user. %M 34185010 %R 10.2196/23990 %U https://publichealth.jmir.org/2021/6/e23990 %U https://doi.org/10.2196/23990 %U http://www.ncbi.nlm.nih.gov/pubmed/34185010 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e24584 %T Effectiveness and Acceptance of Technology-Based Psychological Interventions for the Acute Treatment of Unipolar Depression: Systematic Review and Meta-analysis %A Köhnen,Moritz %A Kriston,Levente %A Härter,Martin %A Baumeister,Harald %A Liebherz,Sarah %+ Department of Medical Psychology, University Medical Center Hamburg–Eppendorf, Martinistr 52, Building West 26, Hamburg, , Germany, 49 40 7410 57705, m.koehnen@uke.de %K internet %K digital health %K digital mental health %K telephone %K psychotherapy %K depressive disorder %K systematic review %K meta-analysis %K technology-based psychological interventions %D 2021 %7 13.6.2021 %9 Review %J J Med Internet Res %G English %X Background: Evidence on technology-based psychological interventions (TBIs) for the acute treatment of depression is rapidly growing. Despite extensive research in this field, there is a lack of research determining effectiveness and acceptance of TBIs considering different application formats in people with a formally diagnosed depressive disorder. Objective: The goal of the review was to investigate the effectiveness and acceptance of TBIs in people with diagnosed depression with particular focus on application formats (stand-alone interventions, blended treatments, collaborative and/or stepped care interventions). Methods: Studies investigating adults with diagnosed unipolar depressive disorders receiving any kind of psychotherapeutic treatment delivered (at least partly) by a technical medium and conducted as randomized controlled trials (RCTs) were eligible for inclusion. We searched CENTRAL (Cochrane Central Register of Controlled Trials; August 2020), MEDLINE, PsycINFO, PSYNDEX, CINAHL (January 2018), clinical trial registers, and sources of grey literature (January 2019). Two independent authors decided about study inclusion and extracted data. We performed random effects meta-analyses to synthesize the data. Results: Database searches resulted in 15,546 records of which 78 completed studies were included. TBIs delivered as stand-alone interventions showed positive effects on posttreatment depression severity when compared to treatment as usual (SMD –0.44, 95% CI –0.73 to –0.15, k=10; I²=86%), attention placebo (SMD –0.51, 95% CI –0.73 to –0.30; k=12; I²=66%), and waitlist controls (SMD –1.01, 95% CI –1.23 to –0.79; k=19; I²=73%). Superior long-term effects on depression severity were shown when TBIs were compared to treatment as usual (SMD –0.24, 95% CI –0.41 to –0.07; k=6; I²=48%) attention placebo (SMD –0.23, 95% CI –0.40 to –0.07; k=7; I²=21%) and waitlist controls (SMD –0.74, 95% CI –1.31 to –0.18; k=3; I²=79%). TBIs delivered as blended treatments (providing a TBI as an add-on to face-to-face treatment) yielded beneficial effects on posttreatment depression severity (SMD –0.27, 95% CI –0.48 to –0.05; k=8; I²=53%) compared to face-to-face treatments only. Additionally, TBIs delivered within collaborative care trials were more effective in reducing posttreatment (SMD –0.20, 95% CI –0.36 to –0.04; k=2; I²=0%) and long-term (SMD –0.23, 95% CI –0.39 to –0.07; k=2; I²=0%) depression severity than usual care. Dropout rates did not differ between the intervention and control groups in any comparison (all P≥.09). Conclusions: We found that TBIs are effective not only when delivered as stand-alone interventions but also when they are delivered as blended treatments or in collaborative care trials for people with diagnosed depression. Our results may be useful to inform routine care, since we focused specifically on different application formats, formally diagnosed patients, and the long-term effectiveness of TBIs. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42016050413; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42016050413 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2018-028042 %M 36260395 %R 10.2196/24584 %U https://www.jmir.org/2021/6/e24584/ %U https://doi.org/10.2196/24584 %U http://www.ncbi.nlm.nih.gov/pubmed/36260395 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e27218 %T Machine Learning Analysis to Identify Digital Behavioral Phenotypes for Engagement and Health Outcome Efficacy of an mHealth Intervention for Obesity: Randomized Controlled Trial %A Kim,Meelim %A Yang,Jaeyeong %A Ahn,Woo-Young %A Choi,Hyung Jin %+ Department of Biomedical Sciences, Seoul National University College of Medicine, 28 Yungun-Dong, Chongno-Gu, Seoul, Republic of Korea, 82 27408204, hjchoi@snu.ac.kr %K digital phenotype %K clinical efficacy %K in-app engagement %K machine learning analysis %K mobile phone %D 2021 %7 24.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The digital health care community has been urged to enhance engagement and clinical outcomes by analyzing multidimensional digital phenotypes. Objective: This study aims to use a machine learning approach to investigate the performance of multivariate phenotypes in predicting the engagement rate and health outcomes of digital cognitive behavioral therapy. Methods: We leveraged both conventional phenotypes assessed by validated psychological questionnaires and multidimensional digital phenotypes within time-series data from a mobile app of 45 participants undergoing digital cognitive behavioral therapy for 8 weeks. We conducted a machine learning analysis to discriminate the important characteristics. Results: A higher engagement rate was associated with higher weight loss at 8 weeks (r=−0.59; P<.001) and 24 weeks (r=−0.52; P=.001). Applying the machine learning approach, lower self-esteem on the conventional phenotype and higher in-app motivational measures on digital phenotypes commonly accounted for both engagement and health outcomes. In addition, 16 types of digital phenotypes (ie, lower intake of high-calorie food and evening snacks and higher interaction frequency with mentors) predicted engagement rates (mean R2 0.416, SD 0.006). The prediction of short-term weight change (mean R2 0.382, SD 0.015) was associated with 13 different digital phenotypes (ie, lower intake of high-calorie food and carbohydrate and higher intake of low-calorie food). Finally, 8 measures of digital phenotypes (ie, lower intake of carbohydrate and evening snacks and higher motivation) were associated with a long-term weight change (mean R2 0.590, SD 0.011). Conclusions: Our findings successfully demonstrated how multiple psychological constructs, such as emotional, cognitive, behavioral, and motivational phenotypes, elucidate the mechanisms and clinical efficacy of a digital intervention using the machine learning method. Accordingly, our study designed an interpretable digital phenotype model, including multiple aspects of motivation before and during the intervention, predicting both engagement and clinical efficacy. This line of research may shed light on the development of advanced prevention and personalized digital therapeutics. Trial Registration: ClinicalTrials.gov NCT03465306; https://clinicaltrials.gov/ct2/show/NCT03465306 %M 34184991 %R 10.2196/27218 %U https://www.jmir.org/2021/6/e27218/ %U https://doi.org/10.2196/27218 %U http://www.ncbi.nlm.nih.gov/pubmed/34184991 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e25256 %T A Multicomponent mHealth-Based Intervention (SWAP IT) to Decrease the Consumption of Discretionary Foods Packed in School Lunchboxes: Type I Effectiveness–Implementation Hybrid Cluster Randomized Controlled Trial %A Sutherland,Rachel %A Brown,Alison %A Nathan,Nicole %A Yoong,Serene %A Janssen,Lisa %A Chooi,Amelia %A Hudson,Nayerra %A Wiggers,John %A Kerr,Nicola %A Evans,Nicole %A Gillham,Karen %A Oldmeadow,Christopher %A Searles,Andrew %A Reeves,Penny %A Davies,Marc %A Reilly,Kathryn %A Cohen,Brad %A Wolfenden,Luke %+ Hunter New England Population Health, Booth Building, Longworth Avenue, Wallsend, Australia, 61 2 4924 6499, rachel.sutherland@health.nsw.gov.au %K childhood obesity %K lunchboxes %K children %K child nutrition %K mHealth %K schools %K hybrid %K randomized controlled trial %K technology %D 2021 %7 24.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: There is significant opportunity to improve the nutritional quality of foods packed in children’s school lunchboxes. Interventions that are effective and scalable targeting the school and home environment are therefore warranted. Objective: This study aimed to assess the effectiveness of a multicomponent, mobile health–based intervention, SWAP IT, in reducing the energy contribution of discretionary (ie, less healthy) foods and drinks packed for children to consume at school. Methods: A type I effectiveness–implementation hybrid cluster randomized controlled trial was conducted in 32 primary schools located across 3 local health districts in New South Wales, Australia, to compare the effects of a 6-month intervention targeting foods packed in children’s lunchboxes with those of a usual care control. Primary schools were eligible if they were not participating in other nutrition studies and used the required school communication app. The Behaviour Change Wheel was used to co-design the multicomponent SWAP IT intervention, which consisted of the following: school lunchbox nutrition guidelines, curriculum lessons, information pushed to parents digitally via an existing school communication app, and additional parent resources to address common barriers to packing healthy lunchboxes. The primary outcome, mean energy (kilojoules) content of discretionary lunchbox foods and drinks packed in lunchboxes, was measured via observation using a validated school food checklist at baseline (May 2019) and at 6-month follow-up (October 2019). Additional secondary outcomes included mean lunchbox energy from discretionary foods consumed, mean total lunchbox energy packed and consumed, mean energy content of core lunchbox foods packed and consumed, and percentage of lunchbox energy from discretionary and core foods, all of which were also measured via observation using a validated school food checklist. Measures of school engagement, consumption of discretionary foods outside of school hours, and lunchbox cost were also collected at baseline and at 6-month follow-up. Data were analyzed via hierarchical linear regression models, with controlling for clustering, socioeconomic status, and remoteness. Results: A total of 3022 (3022/7212, 41.90%) students consented to participate in the evaluation (mean age 7.8 years; 1487/3022, 49.22% girls). There were significant reductions between the intervention and control groups in the primary trial outcome, mean energy (kilojoules) content of discretionary foods packed in lunchboxes (–117.26 kJ; 95% CI –195.59 to –39.83; P=.003). Relative to the control, the intervention also significantly reduced secondary outcomes regarding the mean total lunchbox energy (kilojoules) packed (–88.38 kJ; 95% CI –172.84 to –3.92; P=.04) and consumed (–117.17 kJ; 95% CI –233.72 to –0.62; P=.05). There was no significant difference between groups in measures of student engagement, consumption of discretionary foods outside of school hours, or cost of foods packed in children’s lunchboxes. Conclusions: The SWAP IT intervention was effective in reducing the energy content of foods packed for and consumed by primary school–aged children at school. Dissemination of the SWAP IT program at a population level has the potential to influence a significant proportion of primary school–aged children, impacting weight status and associated health care costs. Trial Registration: Australian Clinical Trials Registry ACTRN12618001731280; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376191&isReview=true International Registered Report Identifier (IRRID): RR2-10.1186/s12889-019-7725-x %M 34185013 %R 10.2196/25256 %U https://www.jmir.org/2021/6/e25256/ %U https://doi.org/10.2196/25256 %U http://www.ncbi.nlm.nih.gov/pubmed/34185013 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e26771 %T Acceptability and Effectiveness of Artificial Intelligence Therapy for Anxiety and Depression (Youper): Longitudinal Observational Study %A Mehta,Ashish %A Niles,Andrea Nicole %A Vargas,Jose Hamilton %A Marafon,Thiago %A Couto,Diego Dotta %A Gross,James Jonathan %+ Department of Psychology, Stanford University, Building 420, 450 Jane Stanford Way, Stanford, CA, 94305, United States, 1 650 724 5436, ashm@stanford.edu %K digital mental health treatment %K acceptability %K effectiveness %K anxiety %K depression %D 2021 %7 22.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Youper is a widely used, commercially available mobile app that uses artificial intelligence therapy for the treatment of anxiety and depression. Objective: Our study examined the acceptability and effectiveness of Youper. Further, we tested the cumulative regulation hypothesis, which posits that cumulative emotion regulation successes with repeated intervention engagement will predict longer-term anxiety and depression symptom reduction. Methods: We examined data from paying Youper users (N=4517) who allowed their data to be used for research. To characterize the acceptability of Youper, we asked users to rate the app on a 5-star scale and measured retention statistics for users’ first 4 weeks of subscription. To examine effectiveness, we examined longitudinal measures of anxiety and depression symptoms. To test the cumulative regulation hypothesis, we used the proportion of successful emotion regulation attempts to predict symptom reduction. Results: Youper users rated the app highly (mean 4.36 stars, SD 0.84), and 42.66% (1927/4517) of users were retained by week 4. Symptoms decreased in the first 2 weeks of app use (anxiety: d=0.57; depression: d=0.46). Anxiety improvements were maintained in the subsequent 2 weeks, but depression symptoms increased slightly with a very small effect size (d=0.05). A higher proportion of successful emotion regulation attempts significantly predicted greater anxiety and depression symptom reduction. Conclusions: Youper is a low-cost, completely self-guided treatment that is accessible to users who may not otherwise access mental health care. Our findings demonstrate the acceptability and effectiveness of Youper as a treatment for anxiety and depression symptoms and support continued study of Youper in a randomized clinical trial. %M 34155984 %R 10.2196/26771 %U https://www.jmir.org/2021/6/e26771 %U https://doi.org/10.2196/26771 %U http://www.ncbi.nlm.nih.gov/pubmed/34155984 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e27853 %T Facebook Users’ Interactions, Organic Reach, and Engagement in a Smoking Cessation Intervention: Content Analysis %A Pócs,Dávid %A Adamovits,Otília %A Watti,Jezdancher %A Kovács,Róbert %A Kelemen,Oguz %+ Department of Behavioral Sciences, Faculty of Medicine, University of Szeged, Szentháromság u. 5, Szeged, 6722, Hungary, 36 62 420 530, drpocsdavid@gmail.com %K smoking %K smoking cessation %K behavior %K health behavior %K internet %K social media %K love %K comment %K motivation %K language %K public health %D 2021 %7 21.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Facebook can be a suitable platform for public health interventions. Facebook users can express their reaction to the given social media content in many ways using interaction buttons. The analysis of these interactions can be advantageous in increasing reach and engagement of public health interventions. Objective: This research aimed at understanding how Facebook users’ interactions correlate with organic reach and engagement regarding the same smoking cessation support contents. Methods: The study population consisted of Facebook users who were reached by a public smoking cessation support page without advertising. We included 1025 nonpaid Facebook posts (N=1025) which used smoking cessation strategies based on a motivational interviewing counseling style. The following data were collected from the “Post Details”: the number of people who saw the given nonpaid content (organic reach) which consisted of fan and nonfan reach according to previous “page like” activity; each rate of “engagement indicators” (such as the symbols of “like,” “love,” “haha,” “wow,” “sad,” “angry”; or other interactions: “shares,” “comments,” “clicks”); and the rate of negative Facebook interactions (eg, “post hides” or “unlike of page”). Overall, these data were analyzed with the Spearman correlation method. Results: Surprisingly, we found a significant negative correlation between organic reach and the “like” reaction (rs=–0.418; P<.001). The strongest significant positive correlations of organic reach were observed with the “haha” reaction (rs=0.396; P<.001), comments (rs=0.368; P<.001), and the “love” reaction (rs=0.264; P<.001). Furthermore, nonfan reach correlated positively with “shares” (rs=0.388; P<.001) and clicks (rs=0.135; P<.001), while fan reach correlated positively with the “haha” reaction (rs=0.457; P<.001), comments (rs=0.393; P<.001), and the “love” reaction (rs=0.310; P<.001). Contrary to expectations, the “like” reaction was sharply separated by significant negative correlations from “wow” (rs=–0.077; P=.013), “sad” (rs=–0.120; P<.001), “angry” reactions (rs=–0.136; P<.001), and comments (rs=–0.130; P<.001). Additionally, a high rate of negative Facebook interactions was significantly associated with “wow” (rs=0.076; P=.016) and “sad” reactions (rs=0.091; P=.003). Conclusions: This study has shown that it is possible to hypothesize a disadvantage of the “like” reaction and advantages of other interactions (eg, the “haha” reaction or “comments”) in content algorithmic ranking on Facebook. In addition, the correlational analysis revealed a need of a further categorization to fan-specific interactions (eg, “haha” or “love” reactions) and nonfan-specific interactions (eg, “shares” and “clicks”). Regarding the direction of the correlations, these findings suggest that some interactions (eg, negative Facebook interactions, “wow,” “sad,” and “angry” reactions) may decrease the engagement, while other interactions (“like,” “love,” “haha” reactions, “shares,” and “clicks”) may increase the engagement during Facebook-based smoking cessation interventions. This hypothesis-generating research offers an important insight into the relationship between organic reach, engagement, and Facebook users’ interactions for public health professionals who design Facebook-based interventions. %M 34152280 %R 10.2196/27853 %U https://www.jmir.org/2021/6/e27853 %U https://doi.org/10.2196/27853 %U http://www.ncbi.nlm.nih.gov/pubmed/34152280 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e25522 %T A Comprehensive 6A Framework for Improving Patient Self-Management of Hypertension Using mHealth Services: Qualitative Thematic Analysis %A Song,Ting %A Liu,Fang %A Deng,Ning %A Qian,Siyu %A Cui,Tingru %A Guan,Yingping %A Arnolda,Leonard %A Zhang,Zhenyu %A Yu,Ping %+ Centre for Digital Transformation, School of Computing and Information Technology, Faculty of Engineering and Information Sciences, University of Wollongong, Northfields Avenue, Wollongong, 2522, Australia, 61 2 4221 5412, ping@uow.edu.au %K patient experience %K mHealth %K mobile phone %K mobile app %K intervention %K self-management %K high blood pressure %K chronic disease management %K qualitative research %D 2021 %7 21.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Hypertension affects over 15% of the world’s population and is a significant global public health and socioeconomic challenge. Mobile health (mHealth) services have been increasingly introduced to support hypertensive patients to improve their self-management behaviors, such as adherence to pharmacotherapy and lifestyle modifications. Objective: This study aims to explore patients’ perceptions of mHealth services and the mechanisms by which the services support them to self-manage their hypertension. Methods: A semistructured, in-depth interview study was conducted with 22 outpatients of the General Hospital of Ningxia Medical University from March to May 2019. In 2015, the hospital introduced an mHealth service to support community-dwelling outpatients with self-management of hypertension. Content analysis was conducted by following a grounded theory approach for inductive thematic extraction. Constant comparison and categorization classified the first-level codes with similar meanings into higher-level themes. Results: The patient-perceived mechanisms by which the mHealth service supported their self-management of hypertension were summarized as 6A: access, assessment, assistance, awareness, ability, and activation. With the portability of mobile phones and digitization of information, the mHealth service provided outpatients with easy access to assess their vital signs and self-management behaviors. The assessment results gave the patients real-time awareness of their health conditions and self-management performance, which activated their self-management behaviors. The mHealth service also gave outpatients access to assistance, which included health education and self-management reminders. Both types of assistance could also be activated by abnormal assessment results, that is, uncontrolled or deteriorating blood pressure values, discomfort symptoms, or not using the service for a long period. With its scalable use to handle any possible information and services, the mHealth service provided outpatients with educational materials to learn at their own pace. This led to an improvement in self-management awareness and ability, again activating their self-management behaviors. The patients would like to see further improvements in the service to provide more useful, personalized information and reliable services. Conclusions: The mHealth service extended the traditional hypertension care model beyond the hospital and clinician’s office. It provided outpatients with easy access to otherwise inaccessible hypertension management services. This led to process improvement for outpatients to access health assessment and health care assistance and improved their awareness and self-management ability, which activated their hypertension self-management behaviors. Future studies can apply the 6A framework to guide the design, implementation, and evaluation of mHealth services for outpatients to self-manage chronic conditions. %M 34152272 %R 10.2196/25522 %U https://www.jmir.org/2021/6/e25522 %U https://doi.org/10.2196/25522 %U http://www.ncbi.nlm.nih.gov/pubmed/34152272 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e25470 %T Fidelity of Delivery and Contextual Factors Influencing Children’s Level of Engagement: Process Evaluation of the Online Remote Behavioral Intervention for Tics Trial %A Khan,Kareem %A Hollis,Chris %A Hall,Charlotte L %A Murray,Elizabeth %A Davies,E Bethan %A Andrén,Per %A Mataix-Cols,David %A Murphy,Tara %A Glazebrook,Cris %+ Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham, Institute of Mental Health, Jubilee Campus, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, United Kingdom, 44 0115 823 1294, kareem.khan@nottingham.ac.uk %K process evaluation %K implementation fidelity %K Tourette syndrome %K chronic tic disorders %K online behavioral intervention %K mixed methods %K children and young people %D 2021 %7 21.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The Online Remote Behavioral Intervention for Tics (ORBIT) study was a multicenter randomized controlled trial of a complex intervention that consisted of a web-based behavioral intervention for children and young people with tic disorders. In the first part of a two-stage process evaluation, we conducted a mixed methods study exploring the reach, dose, and fidelity of the intervention and contextual factors influencing engagement. Objective: This study aims to explore the fidelity of delivery and contextual factors underpinning the ORBIT trial. Methods: Baseline study data and intervention usage metrics from participants in the intervention arm were used as quantitative implementation data (N=112). The experiences of being in the intervention were explored through semistructured interviews with children (n=20) and parent participants (n=20), therapists (n=4), and referring clinicians (n=6). A principal component analysis was used to create a comprehensive, composite measure of children and young people’s engagement with the intervention. Engagement factor scores reflected relative uptake as assessed by a range of usage indices, including chapters accessed, number of pages visited, and number of log-ins. The engagement factor score was used as the dependent variable in a multiple linear regression analysis with various contextual variables as independent variables to assess if there were any significant predictors of engagement. Results: The intervention was implemented with high fidelity, and participants deemed the intervention acceptable and satisfactory. The engagement was high, with child participants completing an average of 7.5 of 10 (SD 2.7) chapters, and 88.4% (99/112) of participants completed the minimum of the first four chapters—the predefined threshold effective dose. Compared with the total population of children with tic disorders, participants in the sample tended to have more educated parents and lived in more economically advantaged areas; however, socioeconomic factors were not related to engagement factor scores. Factors associated with higher engagement factor scores included participants enrolled at the London site versus the Nottingham site (P=.01), self-referred versus clinic referred (P=.04), higher parental engagement as evidenced by the number of parental chapters completed (n=111; ρ=0.73; P<.001), and more therapist time for parents (n=111; ρ=0.46; P<.001). A multiple linear regression indicated that parents’ chapter completion (β=.69; t110=10.18; P<.001) and therapist time for parents (β=.19; t110=2.95; P=.004) were the only significant independent predictors of child engagement factor scores. Conclusions: Overall, the intervention had high fidelity of delivery and was evaluated positively by participants, although reach may have been constrained by the nature of the randomized controlled trial. Parental engagement and therapist time for parents were strong predictors of intervention implementation, which has important implications for designing and implementing digital therapeutic interventions in child and adolescent mental health services. International Registered Report Identifier (IRRID): RR2-10.1186/s13063-019-3974-3 %M 34152270 %R 10.2196/25470 %U https://www.jmir.org/2021/6/e25470 %U https://doi.org/10.2196/25470 %U http://www.ncbi.nlm.nih.gov/pubmed/34152270 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 6 %P e27981 %T Trajectories of Change in an Open-access Internet-Based Cognitive Behavior Program for Childhood and Adolescent Anxiety: Open Trial %A March,Sonja %A Batterham,Philip J %A Rowe,Arlen %A Donovan,Caroline %A Calear,Alison L %A Spence,Susan H %+ Centre for Health Research and School of Psychology and Counselling, University of Southern Queensland, Sinnathamby Blvd, Springfield, 4300, Australia, 61 734704434, sonja.march@usq.edu.au %K iCBT %K child %K adolescent %K anxiety %K online %K trajectories of change %D 2021 %7 18.6.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: Although evidence bolstering the efficacy of internet-based cognitive behavioral therapy (iCBT) for treating childhood anxiety has been growing continuously, there is scant empirical research investigating the timing of benefits made in iCBT programs (eg, early or delayed). Objective: This study aims to examine the patterns of symptom trajectories (changes in anxiety) across an iCBT program for anxiety (BRAVE Self-Help). Methods: This study’s participants included 10,366 Australian youth aged 7 to 17 years (4140 children aged 7-12 years; 6226 adolescents aged 12-17 years) with elevated anxiety who registered for the BRAVE Self-Help program. Participants self-reported their anxiety symptoms at baseline or session 1 and then at the commencement of each subsequent session. Results: The results show that young people completing the BRAVE Self-Help program tend to fall into two trajectory classes that can be reliably identified in terms of high versus moderate baseline levels of anxiety and subsequent reduction in symptoms. Both high and moderate anxiety severity trajectory classes showed significant reductions in anxiety, with the greatest level of change being achieved within the first six sessions for both classes. However, those in the moderate anxiety severity class tended to show reductions in anxiety symptoms to levels below the elevated range, whereas those in the high symptom group tended to remain in the elevated range despite improvements. Conclusions: These findings suggest that those in the high severity group who do not respond well to iCBT on a self-help basis may benefit from the additional support provided alongside the program or a stepped-care approach where progress is monitored and support can be provided as necessary. %M 34142971 %R 10.2196/27981 %U https://mental.jmir.org/2021/6/e27981 %U https://doi.org/10.2196/27981 %U http://www.ncbi.nlm.nih.gov/pubmed/34142971 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e22151 %T The Association Between Logging Steps Using a Website, App, or Fitbit and Engaging With the 10,000 Steps Physical Activity Program: Observational Study %A Rayward,Anna T %A Vandelanotte,Corneel %A Van Itallie,Anetta %A Duncan,Mitch J %+ School of Health, Medical and Applied Sciences, Central Queensland University, Bruce Highway, Rockhampton, 4700, Australia, 61 240553239, anna.rayward@newcastle.edu.au %K physical activity intervention %K activity trackers %K engagement %K Fitbit %K pedometer %K eHealth %K mobile phone %D 2021 %7 18.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Engagement is positively associated with the effectiveness of digital health interventions. It is unclear whether tracking devices that automatically synchronize data (eg, Fitbit) produce different engagement levels compared with manually entering data. Objective: This study examines how different step logging methods in the freely available 10,000 Steps physical activity program differ according to age and gender and are associated with program engagement. Methods: A subsample of users (n=22,142) of the free 10,000 Steps physical activity program were classified into one of the following user groups based on the step-logging method: Website Only (14,617/22,142, 66.01%), App Only (2100/22,142, 9.48%), Fitbit Only (1705/22,142, 7.7%), Web and App (2057/22,142, 9.29%), and Fitbit Combination (combination of web, app, and Fitbit; 1663/22,142, 7.51%). Generalized linear regression and binary logistic regression were used to examine differences between user groups’ engagement and participation parameters. The time to nonusage attrition was assessed using Cox proportional hazards regression. Results: App Only users were significantly younger and Fitbit user groups had higher proportions of women compared with other groups. The following outcomes were significant and relative to the Website Only group. The App Only group had fewer website sessions (odds ratio [OR] −6.9, 95% CI −7.6 to −6.2), whereas the Fitbit Only (OR 10.6, 95% CI 8.8-12.3), Web and App (OR 1.5, 95% CI 0.4-2.6), and Fitbit Combination (OR 8.0; 95% CI 6.2-9.7) groups had more sessions. The App Only (OR −0.7, 95% CI −0.9 to −0.4) and Fitbit Only (OR −0.5, 95% CI −0.7 to −0.2) groups spent fewer minutes on the website per session, whereas the Fitbit Combination group (OR 0.2, 95% CI 0.0-0.5) spent more minutes. All groups, except the Fitbit Combination group, viewed fewer website pages per session. The mean daily step count was lower for the App Only (OR −201.9, 95% CI −387.7 to −116.0) and Fitbit Only (OR −492.9, 95% CI −679.9 to −305.8) groups but higher for the Web and App group (OR 258.0, 95% CI 76.9-439.2). The Fitbit Only (OR 5.0, 95% CI 3.4-6.6), Web and App (OR 7.2, 95% CI 5.9-8.6), and Fitbit Combination (OR 15.6, 95% CI 13.7-17.5) groups logged a greater number of step entries. The App Only group was less likely (OR 0.65, 95% CI 0.46-0.94) and other groups were more likely to participate in Challenges. The mean time to nonusage attrition was 35 (SD 26) days and was lower than average in the Website Only and App Only groups and higher than average in the Web and App and Fitbit Combination groups. Conclusions: Using a Fitbit in combination with the 10,000 Steps app or website enhanced engagement with a real-world physical activity program. Integrating tracking devices that synchronize data automatically into real-world physical activity interventions is one strategy for improving engagement. %M 34142966 %R 10.2196/22151 %U https://www.jmir.org/2021/6/e22151 %U https://doi.org/10.2196/22151 %U http://www.ncbi.nlm.nih.gov/pubmed/34142966 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 6 %P e15551 %T Typology and Impact of YouTube Videos Posted in Response to a Student Suicide Crisis: Social Media Metrics and Content Analyses %A Cheng,Qijin %A Lui,Carrie %A Ip,Flora Wai Lam %A Yip,Paul Siu Fai %+ Hong Kong Jockey Club Centre for Suicide Research and Prevention, The University of Hong Kong, 2/F, 5 Sassoon Road, Pokfulam, Hong Kong, China (Hong Kong), 852 28315232, sfpyip@hku.hk %K suicide %K suicide prevention %K social media %K infodemiology %K internet %K digital health %K YouTube %K impact evaluation %K network visualization %D 2021 %7 18.6.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: Videos relating to suicide are available on YouTube, but their characteristics and impacts have seldom been examined. Objective: This study aimed to examine YouTube videos posted in response to a sudden spate of student suicides in Hong Kong during the 2015-2016 school year and evaluate the impacts of those videos. Methods: Keyword search was performed on YouTube, and relevant videos were identified. Video typology was examined through content analysis, specifically grouping the videos by who uploaded the videos, what presentation formats were used in the videos, whether the videos were originally created by the uploaders, and whether the videos disclosed the uploaders’ personal experiences with suicide. Impacts of the videos were assessed in terms of reach (measured by view count), engagement (measured by comment count), and insights (measured as to what extent the comments to each video could reveal personal suicide risk and attitude toward help-seeking). Statistical analysis was conducted to compare the impacts of different types of videos. The 7 most impactful videos that were originally created by the YouTubers were selected for further analysis. They were compared with 7 videos uploaded by the same YouTubers right before the student suicide videos and 7 right after the student suicide videos. The comparison focused on their impacts and the network structure of the comments to those videos. Results: A total of 162 relevant YouTube videos were identified. They were uploaded by 7 types of stakeholders, and the most common format was one person talking to the camera. A total of 87.0% (141/162) of the videos were originally created by the uploaders and only 8.0% (13/162) of the videos disclosed uploader personal experiences with suicide. The uploader profiles being popular or top YouTubers and the video containing disclosure of the uploader’s personal experiences were found to be significantly correlated with greater impacts (P<.001). Focusing on the 7 most impactful original videos, it is found that those videos generated more engagement, especially more interactions between the viewers, and more insights than regular videos uploaded by the same YouTubers. Conclusions: When responding to a youth suicide crisis, videos made by key opinion leaders on YouTube sharing their own experiences of overcoming suicide risks could generate significant positive impacts. These types of videos offer a precious opportunity to craft online campaigns and activities to raise suicide prevention awareness and engage vulnerable youth. %R 10.2196/15551 %U https://mental.jmir.org/2021/6/e15551/ %U https://doi.org/10.2196/15551 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 7 %N 2 %P e25569 %T Home-Based Telehealth Exercise Intervention in Early-On Survivors of Childhood Acute Lymphoblastic Leukemia: Feasibility Study %A Lambert,Genevieve %A Alos,Nathalie %A Bernier,Pascal %A Laverdière,Caroline %A Kairy,Dahlia %A Drummond,Kenneth %A Dahan-Oliel,Noémi %A Lemay,Martin %A Veilleux,Louis-Nicolas %+ Motion Analysis Center, Shriners Hospital for Children - Canada, 1003 Decarie Blvd, Montreal, QC, H4A 0A9, Canada, 1 514 282 7175, ln.veilleux@mcgill.ca %K exercise therapy %K rehabilitation %K acute lymphoblastic leukemia %K intervention study %K telehealth %K mobile phone %D 2021 %7 16.6.2021 %9 Original Paper %J JMIR Cancer %G English %X Background: Acute lymphoblastic leukemia is the most common type of pediatric cancer. Acute lymphoblastic leukemia causes an altered bone mineral homeostasis state, which can contribute to osteopenia, and bone fractures, most commonly vertebral fractures. With the increasing number of childhood cancer survivors, late adverse effects such as musculoskeletal comorbidities are often reported and are further influenced by inactive lifestyle habits. Physical activity has been shown to increase the mechanical workload of the bone, mitigating bone impairment in other cancer-specific populations. Objective: This interventional pilot study aims to investigate the use of telehealth to deliver a home-based exercise intervention for early-on survivors of bone marrow–related hematological malignancies and to assess its impact on survivors’ musculoskeletal and functional health. Methods: We aimed to recruit a group of 12 early-on survivors of acute lymphoblastic leukemia, within 6 months to 5 years of treatment, to participate in and complete the proposed telehealth intervention with a parent. The 16-week intervention included 40 potential home-based physical activity interventions supervised by a kinesiologist through a telehealth internet platform, with monthly progression. Patients were recruited to the cohort if they were able to participate in the intervention during the first month (minimum 12 weeks of intervention). Evaluation before and after the intervention protocol highlighted differences in functional capacities and musculoskeletal health of patients using mechanography, peripheral quantitative computed tomography, 6-minute walk test, and grip force test. Results: The recruitment rate for the intervention was low (12/57, 21% of contacted patients). Of 12 patients, 3 were excluded (1=relapse, 1=failure to meet technical requirements, and 1=abandoned). The 9 patients who completed the intervention (6 girls; mean age 10.93, SD 2.83 years; mean BMI 21.58, SD 6.55 kg/m2; mean time since treatment completion 36.67, SD 16.37 months) had a mean adherence of 89% and a completion rate of 75%. In addition, these patients showed functional improvements in lower limb muscle force and power as well as in the 6-minute walk test distance. Participants also showed improved bone health after the intervention on the following parameters: bone mineral content, stress-strain index, total and cortical cross-sectional area at the 14% site (P=.03, P=.01, P=.01, and P=.001, respectively) and 38% site of the tibia (P=.003, P=.04, P=.001, and P=.003, respectively). Conclusions: High adherence and participation rates suggest that telehealth is a feasible method to deliver exercise interventions to young early-on survivors of acute lymphoblastic leukemia. The proposed intervention seems promising in providing benefits to patients’ functional performance and bone health, but a large-scale study is needed to confirm this assumption. %M 34132645 %R 10.2196/25569 %U https://cancer.jmir.org/2021/2/e25569 %U https://doi.org/10.2196/25569 %U http://www.ncbi.nlm.nih.gov/pubmed/34132645 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 6 %P e27489 %T Feasibility and Efficacy of Delivering Cognitive Behavioral Therapy Through an Online Psychotherapy Tool for Depression: Protocol for a Randomized Controlled Trial %A Alavi,Nazanin %A Stephenson,Callum %A Yang,Megan %A Kumar,Anchan %A Shao,Yijia %A Miller,Shadé %A Yee,Caitlin S %A Stefatos,Anthi %A Gholamzadehmir,Maedeh %A Abbaspour,Zara %A Jagayat,Jasleen %A Shirazi,Amirhossein %A Omrani,Mohsen %A Patel,Archana %A Patel,Charmy %A Groll,Dianne %+ Department of Psychiatry, Queen's University, Hotel Dieu Hospital, 166 Brock Street, Kingston, ON, K7L 5G2, Canada, 1 6135443310, nalavi@gmail.com %K mental health %K depression %K psychotherapy %K cognitive behavioral therapy %K online %K internet %K electronic %K virtual %K mental health care %D 2021 %7 16.6.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Major depressive disorder (MDD) is a prevalent and debilitating mental health disorder. Among different therapeutic approaches (eg, medication and psychotherapy), psychotherapy in the form of cognitive behavioral therapy (CBT) is considered the gold standard treatment for MDD. However, although efficacious, CBT is not readily accessible to many patients in need because of hurdles such as stigma, long wait times, high cost, the large time commitment for health care providers, and cultural or geographic barriers. Electronically delivered cognitive behavioral therapy (e-CBT) can effectively address many of these accessibility barriers. Objective: This study aims to investigate the efficacy and feasibility of implementing an e-CBT program compared with in-person treatment for MDD. It is hypothesized that the e-CBT program will offer results comparable with those of the in-person treatment program, regarding symptom reduction and quality of life improvement. Methods: This nonrandomized controlled trial intervention will provide e-CBT for MDD through the Online Psychotherapy Tool, a secure, cloud-based, digital mental health platform. Participants (aged 18-65 years) will be offered 12 weekly sessions of an e-CBT program tailored to MDD to address their depressive symptoms. Participants (n=55) will complete predesigned modules and homework assignments while receiving personalized feedback and interacting with a therapist through the platform. Using clinically validated symptomology questionnaires, the efficacy of the e-CBT program will be compared with that of a group (n=55) receiving in-person CBT. Questionnaires will be completed at baseline, at week 6 and week 12, and at a 6-month follow-up. Focus groups will be conducted to investigate personal, cultural, and social factors impacting the accessibility and feasibility of implementing a web-based psychotherapy tool from a patient and care provider perspective. Inclusion criteria include diagnosis of MDD, competence to consent to participate, ability to speak and read English, and consistent and reliable access to the internet. Exclusion criteria include active psychosis, acute mania, severe alcohol or substance use disorder, and active suicidal or homicidal ideation. Results: Ethics approval was obtained in January 2019, and recruitment of participants began in June 2019. Recruitment has been conducted via social media, web-based communities, and physician referrals. To date, 52 participants have been recruited to the e-CBT group, and 48 patients have been recruited to the in-person CBT group. Data collection is expected to be completed by March 2021, and analyses are expected to be completed by June 2021, as linear regression (for continuous outcomes) and binomial regression analysis (for categorical outcomes) are still being conducted. Conclusions: The results of this study can provide valuable information for the development of more accessible and scalable mental health interventions with increased care capacity for MDD, without sacrificing the quality of care. Trial Registration: ClinicalTrials.gov NCT04478058; http://clinicaltrials.gov/ct2/show/NCT04478058 International Registered Report Identifier (IRRID): DERR1-10.2196/27489 %M 33990076 %R 10.2196/27489 %U https://www.researchprotocols.org/2021/6/e27489 %U https://doi.org/10.2196/27489 %U http://www.ncbi.nlm.nih.gov/pubmed/33990076 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e26991 %T Mobile Health in Chronic Disease Management and Patient Empowerment: Exploratory Qualitative Investigation Into Patient-Physician Consultations %A Stampe,Kathrine %A Kishik,Sharon %A Müller,Sune Dueholm %+ Department of Management, School of Business and Social Sciences, Aarhus University, Fuglesangs Allé 4, Aarhus V, DK-8210, Denmark, 45 61776176, sdm@mgmt.au.dk %K compliance %K empowerment %K mHealth %K patient-physician consultation %K power %D 2021 %7 15.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic diseases often present severe consequences for those affected. The management and treatment of chronic diseases largely depend on patients’ lifestyle choices and how they cope with the disease in their everyday lives. Accordingly, the ability of patients to self-manage diseases is a highly relevant topic. In relation to self-management, studies refer to patient empowerment as strengthening patients’ voices and enabling them to assert control over their health and treatment. Mobile health (mHealth) provides cost-efficient means to support self-management and foster empowerment. Objective: There is a scarcity of research investigating how mHealth affects patient empowerment during patient-physician consultations. The objective of this study is to address this knowledge gap by investigating how mHealth affects consultations and patient empowerment. Methods: We relied on data from an ethnographic field study of 6 children and adolescents diagnosed with juvenile idiopathic arthritis. We analyzed 6 patient-physician consultations and drew on Michel Foucault’s concepts of power and power technology. Results: Our results suggest that the use of mHealth constitutes practices that structure the consultations around deviations and noncompliant patient behavior. Our analysis shows how mHealth is used to discipline patients and correct their behavior. We argue that the use of mHealth during consultations may unintentionally lead to relevant aspects of patients’ lives related to the disease being ignored; thus, inadvertently, patients’ voices may be silenced. Conclusions: Our results show that concrete uses of mHealth may conflict with extant literature on empowerment, which emphasizes the importance of strengthening the patients’ voices and enabling patients to take more control of their health and treatment. We contribute to the state-of-the-art knowledge by showing that the use of mHealth may have unintended consequences that do not lead to empowerment. Our analysis underscores the need for further research to investigate how mHealth impacts patient empowerment during consultations. %M 34128817 %R 10.2196/26991 %U https://www.jmir.org/2021/6/e26991 %U https://doi.org/10.2196/26991 %U http://www.ncbi.nlm.nih.gov/pubmed/34128817 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 4 %N 2 %P e19114 %T Efficacy of a Web-Based Intervention (Smart Choices 4 Teens) for Facilitating Parent-Adolescent Communication About Relationships and Sexuality: Randomized Controlled Trial %A Bourdeau,Beth %A Miller,Brenda A %A Byrnes,Hilary F %A Woodall,W Gill %A Buller,David B %A Grube,Joel W %+ Division of Prevention Science, University of California San Francisco, 550 16th Street, 3rd Floor, San Francisco, CA, 94143, United States, 1 4155021000, Beth.Bourdeau@ucsf.edu %K adolescent %K sexual behavior %K parenting %K intervention %K randomized controlled trial %K mobile phone %D 2021 %7 15.6.2021 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: There is a need for interventions that promote healthy decision making among adolescents and leverage the ongoing impact of parental relationships through older adolescence and young adulthood. These interventions should maximize adolescent engagement and be easily accessible to families in terms of cost, duration, and logistics related to participation. Objective: This study aims to test the efficacy of the healthy relationships and sexual decision-making component of a web-based intervention for older adolescents and their parents, ascertain whether the efficacy varies by gender, and assess its efficacy over time. Methods: A randomized controlled trial was conducted for the web-based, self-paced intervention Smart Choices 4 Teens from 2014 to 2015. Families (N=411) with adolescents aged 16-17 years were randomly assigned to the intervention or control condition. Surveys assessing aspects of sexual communication were administered at baseline and at 6, 12, and 18 months. Generalized estimating equations were used to determine the impact of exposure to the relationships component of the intervention on sexual communication by parents, as reported by adolescents. Results: Less than half (88/206, 42.7%) of the intervention group participated in the third and final intervention component, which was focused on relationships and sexual decision making. Participation in the relationships component increased the frequency of parental sexual communication and increased the number of dating rules after accounting for other significant adolescent characteristics. The impact of the intervention varied little by gender, although it did demonstrate an impact on communication reports over the follow-up survey administrations. Conclusions: Smart Choices 4 Teens demonstrated efficacy in increasing the frequency of sexual communication between parents and adolescents in the long term. Trial Registration: ClinicalTrials.gov NCT03521115; https://clinicaltrials.gov/ct2/show/NCT03521115 %M 34128818 %R 10.2196/19114 %U https://pediatrics.jmir.org/2021/2/e19114 %U https://doi.org/10.2196/19114 %U http://www.ncbi.nlm.nih.gov/pubmed/34128818 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 4 %N 2 %P e25671 %T Web-Based Delivery of the Caregiving Essentials Course for Informal Caregivers of Older Adults in Ontario: Mixed Methods Evaluation Study %A Rottenberg,Shelley %A Williams,Allison %+ School of Earth, Environment & Society, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada, 1 905 525 9140, rottensm@mcmaster.ca %K informal caregivers %K family caregivers %K older adults %K elder care %K web-based intervention %K online intervention %K online course %K health education %K eHealth %K evaluation %D 2021 %7 15.6.2021 %9 Original Paper %J JMIR Aging %G English %X Background: Many informal caregivers of older adults have limited time because of the number of responsibilities that their caregiving role entails. This population often experiences high levels of burden due to the stressful nature of their work and are vulnerable to developing negative psychological health outcomes. Easily accessible and flexible knowledge interventions are needed to alleviate the burden and stress experienced by this group. Objective: This study aims to evaluate the acceptability of the web-based delivery of the Caregiving Essentials course for informal caregivers of older adults. Both the strengths and limitations of using a web-based platform to provide information and resources were explored to see whether the method of delivery enhanced or hindered the overall course experience for participants. Methods: A mixed methodology of web-based pre- (n=111) and postcourse surveys (n=39) and telephone interviews (n=26) was used to collect both qualitative and quantitative data from participants. Individual interviews were also conducted with key stakeholders (n=6), and a focus group was conducted with nursing students (n=5) who were involved in the project. Results: The web-based delivery of the course provided participants with greater accessibility to the course because it allowed them to work independently through the modules at their own pace wherever and whenever. The discussion boards were also identified as a major strength because of the opportunity for social interaction and the sense of community that many felt through sharing their experiences. Some barriers to participation included age-related factors, issues with navigating aspects of the course, and concerns about privacy and anonymity. Some key suggestions included more engaging methods of web-based communication and the reorganization of the module content to reduce the amount of text and streamline information. Conclusions: The web-based delivery of Caregiving Essentials appeared to enhance the overall course experience by increasing accessibility and allowing participants to interact with the learning materials and other caregivers. The findings from this evaluation can be used to create and improve the web-based delivery of both the current and emerging interventions for caregivers. %M 34128815 %R 10.2196/25671 %U https://aging.jmir.org/2021/2/e25671 %U https://doi.org/10.2196/25671 %U http://www.ncbi.nlm.nih.gov/pubmed/34128815 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e25069 %T Feasibility and Acceptability of a Mobile Phone App Intervention for Coping With Cancer as a Young Adult: Pilot Trial and Thematic Analysis %A Poort,Hanneke %A Ryan,Annelise %A MacDougall,Katelyn %A Malinowski,Paige %A MacDonald,Anna %A Markin,Zach %A Pirl,William %A Greer,Joseph %A Fasciano,Karen %+ Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, United States, 1 6175827617, hanneke_poort@dfci.harvard.edu %K mobile phone %K mobile phone application %K cancer %K feasibility %D 2021 %7 11.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Many young adult patients do not receive adequate psychosocial services to help them cope with cancer. Objective: This study aims to assess the feasibility and acceptability of a smartphone app (iaya) intervention that was designed to create an engaged community of young adult patients and help them learn emotional coping skills. Methods: For this single-group pilot trial, 25 young adult patients aged 18-39 years who were receiving active cancer treatment were asked to use the iaya app for 12 weeks. To collect app use data, we used Mixpanel, an analytics platform for apps. Feasibility was assessed through rates of app sessions and the number of coping exercises engaged, and intervention acceptability was evaluated by using an app usability questionnaire and through qualitative interviews at study completion. We collected patient-reported outcome data at baseline and at week 12 to explore self-efficacy for coping with cancer, self-efficacy for managing emotions, perceived emotional support, and quality of life. Results: Baseline patient-reported outcome data indicated that participants scored relatively low on perceived emotional support but reasonably high on self-efficacy for coping with cancer and managing emotions as well as quality of life. Participants had a mean of 13 app sessions (SD 14) and 2 coping exercises (SD 3.83) in 12 weeks. Only 9% (2/23) of participants met our combined feasibility definition of ≥10 app sessions and ≥3 coping skills from different categories. The participants’ mean usability score was 73.7% (SD 10.84), which exceeded our predefined threshold of ≥70%, and qualitative feedback was generally positive. Conclusions: Although perceived acceptable by patients, the iaya smartphone app did not meet the a priori feasibility criteria as a stand-alone app intervention. Future studies should screen participants for unmet coping needs and consider integrating the app as part of psychosocial care for young adult patients. %M 34114957 %R 10.2196/25069 %U https://www.jmir.org/2021/6/e25069 %U https://doi.org/10.2196/25069 %U http://www.ncbi.nlm.nih.gov/pubmed/34114957 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 6 %P e21728 %T Web-Based Self-management Program (SPACE for COPD) for Individuals Hospitalized With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease: Nonrandomized Feasibility Trial of Acceptability %A Houchen-Wolloff,Linzy %A Orme,Mark %A Barradell,Amy %A Clinch,Lisa %A Chaplin,Emma %A Gardiner,Nikki %A Singh,Sally J %+ Centre for Exercise and Rehabilitation Science, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, United Kingdom, 44 116 250 2759, Linzy.Houchen@uhl-tr.nhs.uk %K COPD %K telehealth %K digital health %K internet %K rehabilitation %K quantitative %K qualitative %K exercise %D 2021 %7 11.6.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Hospital admissions due to the acute exacerbation of chronic obstructive pulmonary disease (AECOPD) are costly for individuals and health services. Pulmonary rehabilitation (PR) is known to reduce hospital readmissions when delivered after hospitalization, but the uptake and completion of PR following hospitalization remains poor (<10% of those eligible in the UK audit data). A web-based platform of the SPACE (Self-management Program of Activity Coping and Education) for COPD (chronic obstructive pulmonary disease) has previously shown promising results in patients with stable COPD but has not been tested following an AECOPD. Objective: This study aims to assess the feasibility and acceptability of a web-based self-management program. Methods: A nonrandomized feasibility study for patients with confirmed AECOPD who were deemed web literate was conducted. All patients consented during their hospitalization and received access to the website following discharge in addition to usual care. The program aims to facilitate patients to better understand and manage their condition through education and home-based exercises. Participants were asked to complete the Bristol COPD Knowledge Questionnaire at baseline and after 6 months. A total of 14 participants were also interviewed (n=8 completers; n=6 noncompleters) regarding their experiences with the web-based program and trial. The interviews were analyzed using thematic analysis. Results: In total, 2080 patients were screened for eligibility, of which 100 patients (age: mean 71.2 years, SD 9.3 years; male: 55/100, 55%; forced expiratory volume in 1 second/forced vital capacity ratio: mean 0.46, SD 0.14; pack-years: mean 50.2, SD 31.0; current smokers: 35/100, 35%) were recruited (4.8% of those screened). The main reason for ineligibility was a lack of web literacy (1366/1980, 68.98%). In total, 18% (18/100) of patients had completed the web program by 6 months, with others still registered in the program (27/100, 27%), and more than half did not register (55/100, 55%). There was a mean change in Bristol COPD Knowledge Questionnaire scores at 6 months of 7.8 (SD 10.2) points. Qualitative interviews identified three main themes: preparing for, engagement with, and benefits of the study and program. A total of 57% (57/100) accepted a referral to PR on discharge and 19% (19/100) had completed the program after 6 months. Conclusions: On the basis of the challenges of recruiting, retaining, and engaging participants in a web-based self-management program, it is not a feasible approach to roll out widely. This study acknowledges that this is a challenging time for patients with an AECOPD to engage in exercise and self-management education. However, for patients who were able to engage in such an intervention, the completion rate of PR was double the previous audit estimates from the United Kingdom, disease knowledge improved, and the intervention was of value to patients. Trial Registration: ISRCTN Registry 13081008; https://www.isrctn.com/ISRCTN13081008 %M 34114960 %R 10.2196/21728 %U https://mhealth.jmir.org/2021/6/e21728 %U https://doi.org/10.2196/21728 %U http://www.ncbi.nlm.nih.gov/pubmed/34114960 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 6 %P e27526 %T Adaptation of a Live Video Mind–Body Program to a Web-Based Platform for English-Speaking Adults With Neurofibromatosis: Protocol for the NF-Web Study %A Lester,Ethan Gabriel %A Hopkins,Sarah Whitall %A Popok,Paula Jean %A Vranceanu,Ana-Maria %+ Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, 1 Bowdoin Square,, 1st Floor, Suite 100, Boston, MA, 02114, United States, 1 617 724 4977, avranceanu@mgh.harvard.edu %K neurofibromatosis %K quality of life %K stress management %K mind–body %K asynchronous delivery %K resiliency %K mobile phone %D 2021 %7 10.6.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Neurofibromatosis (NF) is a rare genetic condition associated with lower but modifiable quality of life (QoL). Although a virtual live video program (Relaxation Response Resiliency Program for Neurofibromatosis [3RP-NF]; efficacy randomized controlled trial underway) that we created has been made available, ongoing barriers impede some patients from engaging in this intervention. A necessary next step is to develop a stand-alone web-based intervention that reduces barriers to accessing NF-specific psychosocial care. Objective: First, we aim to develop a web-based platform (Neurofibromatosis-Web [NF-Web]) of our mind–body resiliency program (3RP-NF) through qualitative interviews with participants from an adult efficacy randomized controlled trial. Second, we aim to iteratively optimize the feasibility, acceptability, credibility, and satisfaction of the NF-Web platform through open pilot trials with participant exit interviews and explore quantitative outcomes within this sample. Here, we describe the protocol and study design, intervention, and analysis plan. Methods: For aim 1, we will invite completers from our efficacy trial to participate in qualitative interviews. We will use data from these interviews to adapt the content of the live video program for asynchronous delivery and understand how to create a user-friendly format for an engaging web platform. For aim 2, we will enroll eligible participants recruited for the efficacy trial who could not enroll because of treatment barriers. Eligible participants will complete QoL, depression, anxiety, pain, treatment satisfaction, and program credibility measures at baseline and posttest. Inclusion criteria are identical to those for the efficacy trial, including stress and coping difficulties (self-report), no change in antidepressant medication in the past 3 months, no psychotherapy in the past 3 months, no major upcoming surgeries in the next 12 months, English speaking, ability to complete questionnaires on the web and participate in live video interventions, and consent before participation. The primary outcomes are feasibility, treatment satisfaction, and credibility. The secondary outcomes include physical, psychological, social, and environmental QoL; depression; anxiety; pain intensity; and pain interference. We will enroll at least two group cohorts and iteratively refine the program based on participant feedback after each cohort completes the open pilot trial. Results: This trial is ongoing. We have completed the interviews (n=23) and analyzed the data to construct the website. Afterward, we will recruit our cohorts for the trial (approximately n=15/cohort; total=30). Recruitment will end by May 2021, with plans to analyze the data by October 2021. Conclusions: We will develop the first web platform for people with NF with difficulties managing stress and NF symptoms and report on feasibility and preliminary effects in improving QoL and psychosocial functioning. NF-Web has potential to extend the reach of our 3RP-NF intervention by removing barriers to care, including lack of trained providers, scheduling difficulties, and appearance concerns. International Registered Report Identifier (IRRID): DERR1-10.2196/27526 %M 34110294 %R 10.2196/27526 %U https://www.researchprotocols.org/2021/6/e27526 %U https://doi.org/10.2196/27526 %U http://www.ncbi.nlm.nih.gov/pubmed/34110294 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e25794 %T A Web-Based Time-Use Application to Assess Diet and Movement Behavior in Asian Schoolchildren: Development and Usability Study of My E-Diary for Activities and Lifestyle (MEDAL) %A Chia,Airu %A Chew,Muhammad Naeem Jia Sheng %A Tan,Sarah Yi Xuan %A Chan,Mei Jun %A T Colega,Marjorelee %A Toh,Jia Ying %A Natarajan,Padmapriya %A Lança,Carla %A Shek,Lynette P %A Saw,Seang-Mei %A Müller-Riemenschneider,Falk %A Chong,Mary Foong-Fong %+ Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, Singapore, 117549, Singapore, 65 6516 4969, mary_chong@nus.edu.sg %K time use %K web-based %K diet %K movement behaviors %K usability %K schoolchildren %D 2021 %7 9.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based time-use diaries for schoolchildren are limited, and existing studies focus mostly on capturing physical activities and sedentary behaviors but less comprehensively on dietary behaviors. Objective: This study aims to describe the development of My E-Diary for Activities and Lifestyle (MEDAL)—a self-administered, web-based time-use application to assess diet and movement behavior—and to evaluate its usability in schoolchildren in Singapore. Methods: MEDAL was developed through formative research and an iterative user-centric design approach involving small groups of schoolchildren (ranging from n=5 to n=15, aged 7-13 years). To test the usability, children aged 10-11 years were recruited from 2 primary schools in Singapore to complete MEDAL for 2 weekdays and 2 weekend days and complete a 10-item usability questionnaire. Results: The development process revealed that younger children (aged <9 years) were less able to complete MEDAL independently. Of the 204 participants (118/204, 57.8% boys, and 31/201, 15.4% overweight) in the usability study, 57.8% (118/204) completed 3 to 4 days of recording, whereas the rest recorded for 2 days or less. The median time taken to complete MEDAL was 14.2 minutes per day. The majority of participants agreed that instructions were clear (193/203, 95.1%), that MEDAL was easy to use (173/203, 85.2%), that they liked the application (172/202, 85.1%), and that they preferred recording their activities on the web than on paper (167/202, 82.7%). Among all the factors evaluated, recording for 4 days was the least satisfactory component reported. Compared with boys, girls reported better recall ability and agreed that the time spent on completing 1-day entry was appropriate. Conclusions: MEDAL appears to be a feasible application to capture diet and movement behaviors in children aged 10-12 years, particularly in the Asian context. Some gender differences in usability performance were observed, but the majority of the participants had a positive experience using MEDAL. The validation of the data collected through the application is in progress. %M 34106084 %R 10.2196/25794 %U https://www.jmir.org/2021/6/e25794 %U https://doi.org/10.2196/25794 %U http://www.ncbi.nlm.nih.gov/pubmed/34106084 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 4 %N 2 %P e27958 %T Building Primary-School Children’s Resilience through a Web-Based Interactive Learning Environment: Quasi-Experimental Pre-Post Study %A Nicolaidou,Iolie %A Stavrou,Evi %A Leonidou,Georgia %+ Department of Communication and Internet Studies, Cyprus University of Technology, PO Box 50329, Limassol, 3603, Cyprus, 357 25 002105, iolie.nicolaidou@cut.ac.cy %K COVID-19 %K interactive learning environment %K internet-based cognitive behavioral therapy %K parents %K prevention intervention %K primary school children %K psychological resilience %K teachers %D 2021 %7 9.6.2021 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Resilience is a person’s mental ability to deal with challenging situations adaptively and is a crucial stress management skill. Psychological resilience and finding ways to cope in crises is a highly relevant topic considering the COVID-19 pandemic, which enforced quarantine, social distancing measures, and school closures worldwide. Parents and children are currently living with increased stress due to COVID-19. We need to respond with immediate ways to strengthen children’s resilience. Internet-based cognitive behavioral therapy interventions for children's stress management overcome accessibility issues such as the inability to visit mental health experts owing to COVID-19 movement restrictions. An interactive learning environment was created, based on the preventive program “Friends,” to overcome accessibility issues associated with delivering cognitive behavioral therapy–based interventions in formal and informal education settings. Objective: This study aimed to examine the effectiveness of a web-based learning environment on resilience in (1) reducing anxiety symptoms and (2) increasing emotion recognition and recognition of stress management techniques among 9-10-year-old children. We also aimed to evaluate the learning environment’s usability. Methods: A quasi-experimental pretest-posttest control group design was used. In total, 20 fourth graders in the experimental group interacted with the learning environment over 6 weekly 80-minute sessions. Further, 21 fourth graders constituted the control group. The main data sources were (1) a psychometric tool to measure children’s anxiety symptoms, namely the Greek translation of the original Spence Children’s Anxiety Scale, (2) 3 open-ended questions assessing emotion recognition and recognition of stress management techniques, and (3) the System Usability Scale to measure the usability of the learning environment. Results: In both groups, there was a small but nonsignificant postintervention reduction in reported anxiety symptoms, except for obsessive-compulsive disorder symptoms in the experimental group. A paired samples t test revealed that students’ reported symptom scores of obsessive-compulsive disorder significantly decreased from 1.06 (SD 0.68) to 0.76 (SD 0.61) (t19= 5.16; P=.01). The experimental group revealed a significant increase in emotion recognition (t19=–6.99; P<.001), identification of somatic symptoms of stress (t19=–7.31; P<.001), and identification of stress management techniques (t19=–6.85; P<.001). The learning environment received a satisfactory usability score. The raw average system usability score was 76.75 (SD 8.28), which is in the 80th percentile rank and corresponds to grade B. Conclusions: This study shows that interactive learning environments might deliver resilience interventions in an accessible and cost-effective manner in formal education, potentially even in distance-learning conditions owing to the COVID-19 pandemic. Interactive learning environments on resilience are also valuable tools for parents who can use them with their children at home, for informal learning, using mobile devices. As such, they could be a promising first-step, low-intensity intervention that children and the youth can easily access. %M 34106080 %R 10.2196/27958 %U https://pediatrics.jmir.org/2021/2/e27958 %U https://doi.org/10.2196/27958 %U http://www.ncbi.nlm.nih.gov/pubmed/34106080 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 6 %P e24952 %T An Intervention to Improve Medication Adherence in People With Heart Disease (Text4HeartII): Randomized Controlled Trial %A Maddison,Ralph %A Jiang,Yannan %A Stewart,Ralph %A Scott,Tony %A Kerr,Andrew %A Whittaker,Robyn %A Benatar,Jocelyn %A Rolleston,Anna %A Estabrooks,Paul %A Dale,Leila %+ Institute for Physical Activity and Nutrition, Deakin University, 221 Burwood Highway, Burwood, 3125, Australia, 61 3 924 46218, ralph.maddison@deakin.edu.au %K cardiovascular disease %K self-management %K text messaging %K risk factors %D 2021 %7 9.6.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mobile health technologies have the potential to improve the reach and delivery of interventions for promoting long-term secondary prevention of coronary heart disease. Objective: This study aims to determine the effectiveness of an SMS text messaging intervention (Text4HeartII) for improving adherence to medication and lifestyle changes over and above usual care in people with coronary heart disease at 24 and 52 weeks. Methods: A two-arm, parallel, randomized controlled trial was conducted in New Zealand. Participants with a recent acute coronary syndrome were randomized to receive usual cardiac services alone (control, n=153) or a 24-week SMS text message program for supporting self-management plus usual cardiac services (n=153). The primary outcome was adherence to medication at 24 weeks, defined as a medication possession ratio of 80% or more for aspirin, statin, and antihypertensive therapy. Secondary outcomes included medication possession ratio at 52 weeks, self-reported medication adherence, adherence to healthy lifestyle behaviors, and health-related quality of life at 24 and 52 weeks. Results: Participants were predominantly male (113/306, 80.3%) and European New Zealanders (210/306, 68.6%), with a mean age of 61 years (SD 11 years). Groups were comparable at baseline. National hospitalization and pharmacy dispensing records were available for all participants; 92% (282/306, 92.1%) of participants completed a 24-week questionnaire and 95.1% (291/306) of participants completed a 52-week questionnaire. Adherence with 3 medication classes were lower in the intervention group than in the control group (87/153, 56.8% vs 105/153, 68.6%, odds ratio 0.60, 95% CI 0.38-0.96; P=.03) and 52 weeks (104/153, 67.9% vs 83/153, 54.2%; odds ratio 0.56, 95% CI 0.35-0.89; P=.01). Self-reported medication adherence scores showed the same trend at 52 weeks (mean difference 0.3; 95% CI 0.01-0.59; P=.04). Moreover, self-reported adherence to health-related behaviors was similar between groups. Conclusions: Text4HeartII did not improve dispensed medication or adherence to a favorable lifestyle over and above usual care. This finding contrasts with previous studies and highlights that the benefits of text interventions may depend on the context in which they are used. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12616000422426; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370398. International Registered Report Identifier (IRRID): RR2-10.1186/s13063-018-2468-z %M 34106081 %R 10.2196/24952 %U https://mhealth.jmir.org/2021/6/e24952 %U https://doi.org/10.2196/24952 %U http://www.ncbi.nlm.nih.gov/pubmed/34106081 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 6 %P e25952 %T Benefits of Digital Health Resources for Substance Use Concerns in Women: Scoping Review %A Quilty,Lena %A Agic,Branka %A Coombs,Michelle %A Kristy,Betty-Lou %A Shakespeare,Jill %A Spafford,Adrienne %A Besa,Reena %A Dematagoda,Shadini %A Patel,Alina %A Persaud,Rebecca %A Buckley,Leslie %+ Centre for Addiction and Mental Health, 1025 Queen Street West, Toronto, ON, M6J 1H1, Canada, 1 4165358501, Lena.Quilty@camh.ca %K women %K female %K gender-specific %K digital health %K internet %K mobile app %K technology %K technology interventions %K technology-based intervention %K web-based intervention %K substance use concerns %K trauma %D 2021 %7 7.6.2021 %9 Review %J JMIR Ment Health %G English %X Background: Digital health resources are being increasingly used to support women with substance use concerns. Although empirical research has demonstrated that these resources have promise, the available evidence for their benefit in women requires further investigation. Evidence supports the capacity of interventions that are sex-, gender-, and trauma-informed to improve treatment access and outcomes and to reduce health system challenges and disparities. Indeed, both sex- and gender-specific approaches are critical to improve health and gender equity. Violence and trauma are frequent among those with substance use concerns, but they disproportionately affect those who identify as female or women, further underscoring the need for trauma-informed care as well. Objective: The objective of this investigation was to evaluate the evidence supporting the efficacy or effectiveness of online or mobile interventions for risky or harmful substance use in adults who identify as female or women, or who report a history of trauma. Methods: This scoping review is based on an academic search in MEDLINE, APA PsycINFO, Embase, Cochrane Central, and CINAHL, as well as a grey literature search in US and Canadian government and funding agency websites. Of the 7807 records identified, 465 remained following title and abstract screening. Of these, 159 met all eligibility criteria and were reviewed and synthesized. Results: The 159 records reflected 141 distinct studies and 125 distinct interventions. Investigations and the interventions evaluated predominantly focused on alcohol use or general substance use. Evaluated digital health resources included multisession and brief-session interventions, with a wide range of therapeutic elements. Multisession online and mobile interventions exhibited beneficial effects in 86.1% (105/122) of studies. Single-session interventions similarly demonstrated beneficial effects in 64.2% (43/67) of study conditions. Most investigations did not assess gender identity or conduct sex- or gender-based analyses. Only 13 investigations that included trauma were identified. Conclusions: Despite the overall promise of digital health interventions for substance use concerns, direct or quantitative evidence on the efficacy or effectiveness of interventions in females or women specifically is weak. %M 34096879 %R 10.2196/25952 %U https://mental.jmir.org/2021/6/e25952 %U https://doi.org/10.2196/25952 %U http://www.ncbi.nlm.nih.gov/pubmed/34096879 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 6 %P e23986 %T Factors Predicting Trial Engagement, Treatment Satisfaction, and Health-Related Quality of Life During a Web-Based Treatment and Social Networking Trial for Binge Drinking and Depression in Young Adults: Secondary Analysis of a Randomized Controlled Trial %A Sanatkar,Samineh %A Heinsch,Milena %A Baldwin,Peter Andrew %A Rubin,Mark %A Geddes,Jenny %A Hunt,Sally %A Baker,Amanda L %A Woodcock,Kathryn %A Lewin,Terry J %A Brady,Kathleen %A Deady,Mark %A Thornton,Louise %A Teesson,Maree %A Kay-Lambkin,Frances %+ Centre for Brain and Mental Health Research, School of Medicine and Public Health, The University of Newcastle, University Drive, Callaghan, 2308, Australia, 61 02 9065 9179, samineh.sanatkar@uon.edu.au %K digital mental health %K personality %K negative affect %K study engagement %K life quality %D 2021 %7 7.6.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: Mental health and alcohol use problems are among the most common causes of disease burden in young Australians, frequently co-occur (comorbidity), and lead to significant lifetime burden. However, comorbidities remain significantly underdetected and undertreated in health settings. Digital mental health tools designed to identify at-risk individuals, encourage help-seeking, or deliver treatment for comorbidity have the potential to address this service gap. However, despite a strong body of evidence that digital mental health programs provide an effective treatment option for a range of mental health and alcohol use problems in young adults, research shows that uptake rates can be low. Thus, it is important to understand the factors that influence treatment satisfaction and quality-of-life outcomes for young adults who access e–mental health interventions for comorbidity. Objective: In this study, we seek to understand the factors that influence treatment satisfaction and quality-of-life outcomes for young adults who access e–mental health interventions for comorbid alcohol and mood disorders. The aim is to determine the importance of personality (ie, Big Five personality traits and intervention attitudes), affective factors (ie, depression, anxiety, and stress levels), and baseline alcohol consumption in predicting intervention trial engagement at sign-up, satisfaction with the online tool, and quality of life at the end of the iTreAD (Internet Treatment for Alcohol and Depression) trial. Methods: Australian adults (N=411) aged between 18 and 30 years who screened positive for depression and alcohol use problems signed up for the iTreAD project between August 2014 and October 2015. During registration, participants provided information about their personality, current affective state, alcohol use, treatment expectations, and basic demographic information. Subsequent follow-up surveys were used to gauge the ongoing trial engagement. The last follow-up questionnaire, completed at 64 weeks, assessed participants’ satisfaction with web-based treatment and quality-of-life outcomes. Results: Multiple linear regression analyses were used to assess the relative influence of predictor variables on trial engagement, treatment satisfaction, and quality-of-life outcomes. The analyses revealed that the overall predictive effects of personality and affective factors were 20% or lower. Neuroticism constituted a unique predictor of engagement with the iTreAD study in that neuroticism facilitated the return of web-based self-assessments during the study. The return of incentivized follow-up assessments predicted treatment satisfaction, and state-based depression predicted variance in quality-of-life reports at study completion. Conclusions: Our findings suggest that traditional predictors of engagement observed in face-to-face research may not be easily transferable to digital health interventions, particularly those aimed at comorbid mental health concerns and alcohol misuse among young adults. More research is needed to identify what determines engagement in this population to optimally design and execute digital intervention studies with multiple treatment aims. Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN): 12614000310662; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365137&isReview=true. International Registered Report Identifier (IRRID): RR2-10.1186/s12889-015-2365-2 %M 34096873 %R 10.2196/23986 %U https://mental.jmir.org/2021/6/e23986 %U https://doi.org/10.2196/23986 %U http://www.ncbi.nlm.nih.gov/pubmed/34096873 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e20981 %T Weight Loss and Usage of an Online Commercial Weight Loss Program (the CSIRO Total Wellbeing Diet Online) Delivered in an Everyday Context: Five-Year Evaluation in a Community Cohort %A Hendrie,Gilly A %A Baird,Danielle L %A Brindal,Emily %A Williams,Gemma %A Brand-Miller,Jennie %A Muhlhausler,Beverly %+ Nutrition and Health Program, Commonwealth Scientific and Industrial Research Organisation, PO Box 10041, Adelaide, 5000, Australia, 61 8 8305 0662, GILLY.HENDRIE@CSIRO.AU %K obesity %K obesity management %K weight loss %K internet-based intervention %D 2021 %7 7.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Obesity is a global public health challenge, and there is a need for more evidence-based self-management programs that support longer-term, sustained weight loss. Objective: This study used data from the Commonwealth Scientific and Industrial Research Organisation (CSIRO) Total Wellbeing Diet Online program to determine the reach and weight loss results over its first 5 years. Methods: Participants were adults who joined the commercial weight loss program of their own volition between October 2014 and September 2019 (N=61,164). Information collected included year of birth, sex, height, weight, and usage data (eg, entries into the food diary, views of the menu, and program content). Weight loss and percentage of starting body weight lost were calculated. Members were divided into 2 groups for analysis: “stayers” were members who signed up for at least 12 weeks of the program and recorded a weight entry at baseline and at the end of the program, while “starters” began the program but did not record a weight after 12 weeks. Descriptive statistics and multiple linear regression were used to describe weight loss and determine the member and program characteristics associated with weight loss. Results: Data were available from 59,686 members for analysis. Members were predominately female (48,979/59,686, 82.06%) with an average age of 50 years (SD 12.6). The average starting weight was 90.2 kg (SD 19.7), and over half of all members (34,195/59,688, 57.29%) were classified as obese. At week 12, 94.56% (56,438/59,686) of the members had a paid program membership, which decreased to 41.48% (24,756/59,686) at 24 weeks. At week 12, 52.03% (29,115/55,958) of the remaining members were actively using the platform, and by week 24, 26.59% (14,880/55,958) were using the platform. The average weight loss for all members was 2.8 kg or 3.1% of their starting body weight. Stayers lost 4.9 kg (5.3% of starting body weight) compared to starters, who lost 1.6 kg (1.7% of starting body weight). Almost half (11,082/22,658, 48.91%) the members who stayed on the program lost 5% or more of their starting body weight, and 15.48% (3507/22,658) achieved a weight loss of 10% or more. Of the members who were classified as class 1 obese when they joined the program, 41.39% (3065/7405) who stayed on the program were no longer classified as obese at the end, and across all categories of obesity, 24% (3180/13,319) were no longer classified as obese at the end of the program. Based on multiple linear regression, platform usage was the strongest predictor of weight loss (β=.263; P<.001), with higher usage associated with greater weight loss. Conclusions: This comprehensive evaluation of a commercial, online weight loss program showed that it was effective for weight loss, particularly for members who finished the program and were active in using the platform and tools provided. If the results demonstrated here can be achieved at an even greater scale, the potential social and economic benefits will be extremely significant. %M 34096869 %R 10.2196/20981 %U https://www.jmir.org/2021/6/e20981 %U https://doi.org/10.2196/20981 %U http://www.ncbi.nlm.nih.gov/pubmed/34096869 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e24712 %T Evaluation of the Effectiveness of Digital Technology Interventions to Reduce Loneliness in Older Adults: Systematic Review and Meta-analysis %A Shah,Syed Ghulam Sarwar %A Nogueras,David %A van Woerden,Hugo Cornelis %A Kiparoglou,Vasiliki %+ NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, OX3 9DU, United Kingdom, 44 1865221262, sarwar.shah@ouh.nhs.uk %K loneliness %K older people %K digital technology %K effectiveness %K efficacy %K evidence %K systematic review %K meta-analysis %D 2021 %7 4.6.2021 %9 Review %J J Med Internet Res %G English %X Background: Loneliness is a serious public health issue, and its burden is increasing in many countries. Loneliness affects social, physical, and mental health, and it is associated with multimorbidity and premature mortality. In addition to social interventions, a range of digital technology interventions (DTIs) are being used to tackle loneliness. However, there is limited evidence on the effectiveness of DTIs in reducing loneliness, especially in adults. The effectiveness of DTIs in reducing loneliness needs to be systematically assessed. Objective: The objective of this study is to assess the effectiveness of DTIs in reducing loneliness in older adults. Methods: We conducted electronic searches in PubMed, MEDLINE, CINAHL, Embase, and Web of Science for empirical studies published in English from January 1, 2010, to July 31, 2019. The study selection criteria included interventional studies that used any type of DTIs to reduce loneliness in adults (aged ≥18 years) with a minimum intervention duration of 3 months and follow-up measurements at least 3 months after the intervention. Two researchers independently screened articles and extracted data using the PICO (participant, intervention, comparator, and outcome) framework. The primary outcome measure was loneliness. Loneliness scores in both the intervention and control groups at baseline and at follow-up at 3, 4, 6, and 12 months after the intervention were extracted. Data were analyzed via narrative synthesis and meta-analysis using RevMan (The Cochrane Collaboration) software. Results: A total of 6 studies were selected from 4939 screened articles. These studies included 1 before and after study and 5 clinical trials (4 randomized clinical trials and 1 quasi-experimental study). All of these studies enrolled a total of 646 participants (men: n=154, 23.8%; women: n=427, 66.1%; no gender information: n=65, 10.1%) with an average age of 73-78 years (SD 6-11). Five clinical trials were included in the meta-analysis, and by using the random effects model, standardized mean differences (SMDs) were calculated for each trial and pooled across studies at the 3-, 4-, and 6-month follow-ups. The overall effect estimates showed no statistically significant difference in the effectiveness of DTIs compared with that of usual care or non-DTIs at follow-up at 3 months (SMD 0.02; 95% CI −0.36 to 0.40; P=.92), 4 months (SMD −1.11; 95% CI −2.60 to 0.38; P=.14), and 6 months (SMD −0.11; 95% CI −0.54 to 0.32; P=.61). The quality of evidence was very low to moderate in these trials. Conclusions: Our meta-analysis shows no evidence supporting the effectiveness of DTIs in reducing loneliness in older adults. Future research may consider randomized controlled trials with larger sample sizes and longer durations for both the interventions and follow-ups. International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2019-032455 %M 34085942 %R 10.2196/24712 %U https://www.jmir.org/2021/6/e24712 %U https://doi.org/10.2196/24712 %U http://www.ncbi.nlm.nih.gov/pubmed/34085942 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e26421 %T Influence of Baseline User Characteristics and Early Use Patterns (24-Hour) on Long-Term Adherence and Effectiveness of a Web-Based Weight Loss Randomized Controlled Trial: Latent Profile Analysis %A Andrade,Andre Q %A Beleigoli,Alline %A Diniz,Maria De Fatima %A Ribeiro,Antonio Luiz %+ Flinders Digital Health Research Centre, Flinders University, Tonsley Boulevard, Tonsley, Adelaide, , Australia, 61 08 2013303, alline.beleigoli@flinders.edu.au %K obesity %K overweight %K web platform %K digital health %K engagement %K latent profile analysis %K online interventions %K use data %K weight loss %K weight loss platform %D 2021 %7 3.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Low adherence to real-world online weight loss interventions reduces long-term efficacy. Baseline characteristics and use patterns are determinants of long-term adherence, but we lack cohesive models to guide how to adapt interventions to users’ needs. We also lack information whether very early use patterns (24 hours) help describe users and predict interventions they would benefit from. Objective: We aim to understand the impact of users’ baseline characteristics and early (initial 24 hours) use patterns of a web platform for weight loss on user adherence and weight loss in the long term (24 weeks). Methods: We analyzed data from the POEmaS randomized controlled trial, a study that compared the effectiveness of a weight loss platform with or without coaching and a control approach. Data included baseline behavior and use logs from the initial 24 hours after platform access. Latent profile analysis (LPA) was used to identify classes, and Kruskal-Wallis was used to test whether class membership was associated with long-term (24 weeks) adherence and weight loss. Results: Among 828 participants assigned to intervention arms, 3 classes were identified through LPA: class 1 (better baseline health habits and high 24-hour platform use); class 2 (better than average health habits, but low 24-hour platform use); class 3 (worse baseline health habits and low 24-hour platform use). Class membership was associated with long-term adherence (P<.001), and class 3 members had the lowest adherence. Weight loss was not associated with class membership (P=.49), regardless of the intervention arm (platform only or platform + coach). However, class 2 users assigned to platform + coach lost more weight than those assigned to platform only (P=.02). Conclusions: Baseline questionnaires and use data from the first 24 hours after log-in allowed distinguishing classes, which were associated with long-term adherence. This suggests that this classification might be a useful guide to improve adherence and assign interventions to individual users. Trial Registration: ClinicalTrials.gov NCT03435445; https://clinicaltrials.gov/ct2/show/NCT03435445 International Registered Report Identifier (IRRID): RR2-10.1186/s12889-018-5882-y %M 34081012 %R 10.2196/26421 %U https://www.jmir.org/2021/6/e26421 %U https://doi.org/10.2196/26421 %U http://www.ncbi.nlm.nih.gov/pubmed/34081012 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e26143 %T Patients and Professionals as Partners in Hypertension Care: Qualitative Substudy of a Randomized Controlled Trial Using an Interactive Web-Based System Via Mobile Phone %A Andersson,Ulrika %A Bengtsson,Ulrika %A Ranerup,Agneta %A Midlöv,Patrik %A Kjellgren,Karin %+ Department of Clinical Sciences Malmö, Lund University, PO Box 50332, Malmö, 202 13, Sweden, 46 070 6251729, ulrika.andersson.4418@med.lu.se %K eHealth %K digital health %K hypertension %K mobile phones %K patient-professional partnership %K person-centered care %K self-management %D 2021 %7 3.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The use of technology has the potential to support the patient´s active participation regarding treatment of hypertension. This might lead to changes in the roles of the patient and health care professional and affect the partnership between them. Objective: The aim of this qualitative study was to explore the partnership between patients and health care professionals and the roles of patients and professionals in hypertension management when using an interactive web-based system for self-management of hypertension via the patient’s own mobile phone. Methods: Focus group interviews were conducted with 22 patients and 15 professionals participating in a randomized controlled trial in Sweden aimed at lowering blood pressure (BP) using an interactive web-based system via mobile phones. The interviews were audiorecorded and transcribed and analyzed using thematic analysis. Results: Three themes were identified: the technology, the patient, and the professional. The technology enabled documentation of BP treatment, mainly for sharing knowledge between the patient and the professional. The patients gained increased knowledge of BP values and their relation to daily activities and treatment. They were able to narrate about their BP treatment and take a greater responsibility, inspired by new insights and motivation for lifestyle changes. Based on the patient’s understanding of hypertension, professionals could use the system as an educational tool and some found new ways of communicating BP treatment with patients. Some reservations were raised about using the system, that it might be too time-consuming to function in clinical practice and that too much measuring could result in stress for the patient and an increased workload for the professionals. In addition, not all professionals and patients had adopted the instructions regarding the use of the system, resulting in less realization of its potential. Conclusions: The use of the system led to the patients taking on a more active role in their BP treatment, becoming more of an expert of their BP. When using the system as intended, the professionals experienced it as a useful resource for communication regarding BP and lifestyle. Patients and professionals described a consultation on more equal grounds. The use of technology in hypertension management can promote a constructive and person-centered partnership between patient and professional. However, implementation of a new way of working should bring benefits and not be considered a burden for the professionals. To establish a successful partnership, both the patient and the professional need to be motivated toward a new way of working. Trial Registration: ClinicalTrials.gov NCT03554382; https://clinicaltrials.gov/ct2/show/NCT03554382 %M 34081021 %R 10.2196/26143 %U https://www.jmir.org/2021/6/e26143 %U https://doi.org/10.2196/26143 %U http://www.ncbi.nlm.nih.gov/pubmed/34081021 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e25006 %T Chatbots to Support People With Dementia and Their Caregivers: Systematic Review of Functions and Quality %A Ruggiano,Nicole %A Brown,Ellen L %A Roberts,Lisa %A Framil Suarez,C Victoria %A Luo,Yan %A Hao,Zhichao %A Hristidis,Vagelis %+ Department of Computer Science and Engineering, University of California, Riverside, 317 Winston Chung Hall, 900 University Ave, Riverside, CA, 92521, United States, 1 951 827 2478, vagelis@cs.ucr.edu %K dementia %K caregivers %K chatbots %K conversation agents %K mobile apps %K mobile phone %D 2021 %7 3.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Over the past decade, there has been an increase in the use of information technologies to educate and support people with dementia and their family caregivers. At the same time, chatbot technologies have become increasingly popular for use by the public and have been identified as having benefits for health care delivery. However, little is known about how chatbot technologies may benefit people with dementia and their caregivers. Objective: This study aims to identify the types of current commercially available chatbots that are designed for use by people with dementia and their caregivers and to assess their quality in terms of features and content. Methods: Chatbots were identified through a systematic search on Google Play Store, Apple App Store, Alexa Skills, and the internet. An evidence-based assessment tool was used to evaluate the features and content of the identified apps. The assessment was conducted through interrater agreement among 4 separate reviewers. Results: Of the 505 initial chatbots identified, 6 were included in the review. The chatbots assessed varied significantly in terms of content and scope. Although the chatbots were generally found to be easy to use, some limitations were noted regarding their performance and programmed content for dialog. Conclusions: Although chatbot technologies are well established and commonly used by the public, their development for people with dementia and their caregivers is in its infancy. Given the successful use of chatbots in other health care settings and for other applications, there are opportunities to integrate this technology into dementia care. However, more evidence-based chatbots that have undergone end user evaluation are needed to evaluate their potential to adequately educate and support these populations. %M 34081019 %R 10.2196/25006 %U https://www.jmir.org/2021/6/e25006 %U https://doi.org/10.2196/25006 %U http://www.ncbi.nlm.nih.gov/pubmed/34081019 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e23473 %T Application of the eHealth Literacy Model in Digital Health Interventions: Scoping Review %A El Benny,Mariam %A Kabakian-Khasholian,Tamar %A El-Jardali,Fadi %A Bardus,Marco %+ Department of Health Promotion and Community Health, Faculty of Health Sciences, American University of Beirut, PO-Box 11-0236, Riad-El-Solh, Beirut, 1107 2020, Lebanon, 961 1 350 0000 ext 4694, marco.bardus@gmail.com %K eHealth literacy %K digital health interventions %K consumer health information %K scoping review %K mHealth %K mobile phone %D 2021 %7 3.6.2021 %9 Review %J J Med Internet Res %G English %X Background: Digital health interventions (DHIs) are increasingly being adopted globally to address various public health issues. DHIs can be categorized according to four main types of technology: mobile based, web based, telehealth, and electronic health records. In 2006, Norman and Skinner introduced the eHealth literacy model, encompassing six domains of skills and abilities (basic, health, information, scientific, media, and computer) needed to effectively understand, process, and act on health-related information. Little is known about whether these domains are assessed or accounted for in DHIs. Objective: This study aims to explore how DHIs assess and evaluate the eHealth literacy model, describe which health conditions are addressed, and which technologies are used. Methods: We conducted a scoping review of the literature on DHIs, based on randomized controlled trial design and reporting the assessment of any domain of the eHealth literacy model. MEDLINE, CINAHL, Embase, and Cochrane Library were searched. A duplicate selection and data extraction process was performed; we charted the results according to the country of origin, health condition, technology used, and eHealth literacy domain. Results: We identified 131 unique DHIs conducted in 26 different countries between 2001 and 2020. Most DHIs were conducted in English-speaking countries (n=81, 61.8%), delivered via the web (n=68, 51.9%), and addressed issues related to noncommunicable diseases (n=57, 43.5%) or mental health (n=26, 19.8%). None of the interventions assessed all six domains of the eHealth literacy model. Most studies focused on the domain of health literacy (n=96, 73.2%), followed by digital (n=19, 14.5%), basic and media (n=4, 3%), and information and scientific literacy (n=1, 0.7%). Of the 131 studies, 7 (5.3%) studies covered both health and digital literacy. Conclusions: Although many selected DHIs assessed health or digital literacy, no studies comprehensively evaluated all domains of the eHealth literacy model; this evidence might be overlooking important factors that can mediate or moderate the effects of these interventions. Future DHIs should comprehensively assess the eHealth literacy model while developing or evaluating interventions to understand how and why interventions can be effective. %M 34081023 %R 10.2196/23473 %U https://www.jmir.org/2021/6/e23473 %U https://doi.org/10.2196/23473 %U http://www.ncbi.nlm.nih.gov/pubmed/34081023 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 6 %P e24901 %T Assessing Health-Related Quality of Life, Morbidity, and Survival Status for Individuals With Down Syndrome in Pakistan (DS-Pak): Protocol for a Web-Based Collaborative Registry %A Siddiqui,Ayat %A Ladak,Laila Akbar %A Kazi,Abdul Momin %A Kaleem,Sidra %A Akbar,Fizza %A Kirmani,Salman %+ Department of Pediatrics, Aga Khan University Hospital, National Stadium Rd, Karachi, 74800, Pakistan, 92 34930051, laila.ladak@aku.edu %K Down syndrome %K registry %K web-based registry %K health-related quality of life %K lower-middle income country %K mobile health %K patient-reported outcome %D 2021 %7 3.6.2021 %9 Proposal %J JMIR Res Protoc %G English %X Background: Down syndrome is the most common chromosomal disorder, with a global incidence of 1 in 700 live births. However, the true prevalence, associated morbidities, and health-related quality of life (HRQOL) of these individuals and their families are not well documented, especially in low- and middle-income countries such as Pakistan. Disease-specific documentation in the form of a collaborative registry is required to better understand this condition and the associated health outcomes. This protocol paper describes the aims and processes for developing the first comprehensive, web-based collaborative registry for Down syndrome in a Pakistani cohort. Objective: This study aims to assess the HRQOL, long-term survival, and morbidity of individuals with Down syndrome by using a web-based collaborative registry. Methods: The registry data collection will be conducted at the Aga Khan University Hospital and at the Karachi Down Syndrome Program. Data will be collected by in-person interviews or virtually via telephone or video interviews. Participants of any age and sex with Down syndrome (trisomy 21) will be recruited. After receiving informed consent and assent, a series of tablet-based questionnaires will be administered. The questionnaires aim to assess the sociodemographic background, clinical status, and HRQOL of the participants and their families. Data will be uploaded to a secure cloud server to allow for real-time access to participant responses by the clinicians to plan prompt interventions. Patient safety and confidentiality will be maintained by using multilayer encryption and unique coded patient identifiers. The collected data will be analyzed using IBM SPSS Statistics for Windows, Version 22.0 (IBM Corporation), with the mean and SD of continuous variables being reported. Categorical variables will be analyzed with their percentages being reported and with a P value cutoff of .05. Multivariate regression analysis will be conducted to identify predictors related to the HRQOL in patients with Down syndrome. Survival analysis will be reported using the Kaplan-Meier survival curves. Results: The web-based questionnaire is currently being finalized before the commencement of pilot testing. This project has not received funding at the moment (ethical review committee approval reference ID: 2020-3582-11145). Conclusions: This registry will allow for a comprehensive understanding of Down syndrome in low- and middle-income countries. This can provide the opportunity for data-informed interventions, which are tailored to the specific needs of this patient population and their families. Although this web-based registry is a proof of concept, it has the potential to be expanded to national, regional, and international levels. International Registered Report Identifier (IRRID): PRR1-10.2196/24901 %M 34081014 %R 10.2196/24901 %U https://www.researchprotocols.org/2021/6/e24901 %U https://doi.org/10.2196/24901 %U http://www.ncbi.nlm.nih.gov/pubmed/34081014 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 2 %P e28033 %T Improved Glycemic Control With a Digital Health Intervention in Adults With Type 2 Diabetes: Retrospective Study %A Zimmermann,Gretchen %A Venkatesan,Aarathi %A Rawlings,Kelly %A Scahill,Michael D %+ Vida Health, 100 Montgomery Street, Suite 750, San Francisco, CA, 94104, United States, 1 415 989 1017, aarathi.venkatesan@vida.com %K type 2 diabetes %K digital health %K diabetes intervention %K diabetes %K mobile health %K mHealth %K app-based %K health coaching %K HbA1c %K glycemic improvements %D 2021 %7 2.6.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Traditional lifestyle interventions have shown limited success in improving diabetes-related outcomes. Digital interventions with continuously available support and personalized educational content may offer unique advantages for self-management and glycemic control. Objective: In this study, we evaluated changes in glycemic control among participants with type 2 diabetes who enrolled in a digital diabetes management program. Methods: The study employed a single-arm, retrospective design. A total of 950 participants with a hemoglobin A1c (HbA1c) baseline value of at least 7.0% enrolled in the Vida Health Diabetes Management Program. The intervention included one-to-one remote sessions with a Vida provider and structured lessons and tools related to diabetes management. HbA1c was the primary outcome measure. Of the 950 participants, 258 (27.2%) had a follow-up HbA1c completed at least 90 days from program start. Paired t tests were used to evaluate changes in HbA1c between baseline and follow-up. Additionally, a cluster-robust multiple regression analysis was employed to evaluate the relationship between high and low program usage and HbA1c change. A repeated measures analysis of variance was used to evaluate the difference in HbA1c as a function of the measurement period (ie, pre-Vida enrollment, baseline, and postenrollment follow-up). Results: We observed a significant reduction in HbA1c of –0.81 points between baseline (mean 8.68, SD 1.7) and follow-up (mean 7.88, SD 1.46; t257=7.71; P<.001). Among participants considered high risk (baseline HbA1c≥8), there was an average reduction of –1.44 points between baseline (mean 9.73, SD 1.68) and follow-up (mean 8.29, SD 1.64; t139=9.14; P<.001). Additionally, average follow-up HbA1c (mean 7.82, SD 1.41) was significantly lower than pre-enrollment HbA1c (mean 8.12, SD 1.46; F2, 210=22.90; P<.001) There was also significant effect of program usage on HbA1c change (β=–.60; P<.001) such that high usage was associated with a greater decrease in HbA1c (mean –1.02, SD 1.60) compared to low usage (mean –.61, SD 1.72). Conclusions: The present study revealed clinically meaningful improvements in glycemic control among participants enrolled in a digital diabetes management intervention. Higher program usage was associated with greater improvements in HbA1c. The findings of the present study suggest that a digital health intervention may represent an accessible, scalable, and effective solution to diabetes management and improved HbA1c. The study was limited by a nonrandomized, observational design and limited postenrollment follow-up data. %M 34075880 %R 10.2196/28033 %U https://diabetes.jmir.org/2021/2/e28033 %U https://doi.org/10.2196/28033 %U http://www.ncbi.nlm.nih.gov/pubmed/34075880 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e24303 %T Sexual Health Influencer Distribution of HIV/Syphilis Self-Tests Among Men Who Have Sex With Men in China: Secondary Analysis to Inform Community-Based Interventions %A Yang,Nancy %A Wu,Dan %A Zhou,Yi %A Huang,Shanzi %A He,Xi %A Tucker,Joseph %A Li,Xiaofeng %A Smith,Kumi M %A Jiang,Xiaohui %A Wang,Yehua %A Huang,Wenting %A Fu,Hongyun %A Bao,Huanyu %A Jiang,Hongbo %A Dai,Wencan %A Tang,Weiming %+ Dermatology Hospital of Southern Medical University, No 2 Lujing Road, Yuexiu District, Guangzhou, 510091, China, 86 15920567132, weiming_tang@med.unc.edu %K sexual health influencer %K men who have sex with men %K HIV %K syphilis %K self-test %K sexual health %K influencer %K social network %K peers %D 2021 %7 1.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Social network–based strategies can expand HIV/syphilis self-tests among men who have sex with men (MSM). Sexual health influencers are individuals who are particularly capable of spreading information about HIV and other sexually transmitted infections (STIs) within their social networks. However, it remains unknown whether a sexual health influencer can encourage their peers to self-test for HIV/syphilis. Objective: The aims of this study were to examine the impact of MSM sexual health influencers on improving HIV/syphilis self-test uptake within their social networks compared to that of nonsexual health influencers. Methods: In Zhuhai, China, men 16 years or older, born biologically male, who reported ever having had sex with a man, and applying for HIV/syphilis self-tests were enrolled online as indexes and encouraged to distribute self-tests to individuals (alters) in their social network. Indexes scoring >3 on a sexual health influencer scale were considered to be sexual health influencers (Cronbach α=.87). The primary outcome was the mean number of alters encouraged to test per index for sexual health influencers compared with the number encouraged by noninfluencers. Results: Participants included 371 indexes and 278 alters. Among indexes, 77 (20.8%) were sexual health influencers and 294 (79.2%) were noninfluencers. On average, each sexual health influencer successfully encouraged 1.66 alters to self-test compared to 0.51 alters encouraged by each noninfluencer (adjusted rate ratio 2.07, 95% CI 1.59-2.69). More sexual health influencers disclosed their sexual orientation (80.5% vs 67.3%, P=.02) and were community-based organization volunteers (18.2% vs 2.7%, P<.001) than noninfluencers. More alters of sexual health influencers came from a rural area (45.5% vs 23.8%, P<.001), had below-college education (57.7% vs 37.1%, P<.001), and had multiple casual male sexual partners in the past 6 months (25.2% vs 11.9%, P<.001). Conclusions: Being a sexual health influencer was associated with encouraging more alters with less testing access to self-test for HIV/syphilis. Sexual health influencers can be engaged as seeds to expand HIV/syphilis testing coverage. %M 34061035 %R 10.2196/24303 %U https://www.jmir.org/2021/6/e24303 %U https://doi.org/10.2196/24303 %U http://www.ncbi.nlm.nih.gov/pubmed/34061035 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 5 %P e27965 %T Engagement and Effectiveness of a Healthy-Coping Intervention via Chatbot for University Students During the COVID-19 Pandemic: Mixed Methods Proof-of-Concept Study %A Gabrielli,Silvia %A Rizzi,Silvia %A Bassi,Giulia %A Carbone,Sara %A Maimone,Rosa %A Marchesoni,Michele %A Forti,Stefano %+ Digital Health Lab, Fondazione Bruno Kessler, Via Sommarive 18, Trento, 38123, Italy, 39 0461 312 47 ext 247, sgabrielli@fbk.eu %K mobile mental health %K chatbots %K anxiety %K stress %K university students %K digital health %K healthy-coping intervention %K COVID-19 %D 2021 %7 28.5.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: University students are increasingly reporting common mental health problems, such as stress, anxiety, and depression, and they frequently face barriers to seeking psychological support because of stigma, cost, and availability of mental health services. This issue is even more critical in the challenging time of the COVID-19 pandemic. Digital mental health interventions, such as those delivered via chatbots on mobile devices, offer the potential to achieve scalability of healthy-coping interventions by lowering cost and supporting prevention. Objective: The goal of this study was to conduct a proof-of-concept evaluation measuring the engagement and effectiveness of Atena, a psychoeducational chatbot supporting healthy coping with stress and anxiety, among a population of university students. Methods: In a proof-of-concept study, 71 university students were recruited during the COVID-19 pandemic; 68% (48/71) were female, they were all in their first year of university, and their mean age was 20.6 years (SD 2.4). Enrolled students were asked to use the Atena psychoeducational chatbot for 4 weeks (eight sessions; two per week), which provided healthy-coping strategies based on cognitive behavioral therapy, positive psychology, and mindfulness techniques. The intervention program consisted of conversations combined with audiovisual clips delivered via the Atena chatbot. Participants were asked to complete web-based versions of the 7-item Generalized Anxiety Disorder scale (GAD-7), the 10-item Perceived Stress Scale (PSS-10), and the Five-Facet Mindfulness Questionnaire (FFMQ) at baseline and postintervention to assess effectiveness. They were also asked to complete the User Engagement Scale–Short Form at week 2 to assess engagement with the chatbot and to provide qualitative comments on their overall experience with Atena postintervention. Results: Participants engaged with the Atena chatbot an average of 78 (SD 24.8) times over the study period. A total of 61 out of 71 (86%) participants completed the first 2 weeks of the intervention and provided data on engagement (10/71, 14% attrition). A total of 41 participants out of 71 (58%) completed the full intervention and the postintervention questionnaires (30/71, 42% attrition). Results from the completer analysis showed a significant decrease in anxiety symptoms for participants in more extreme GAD-7 score ranges (t39=0.94; P=.009) and a decrease in stress symptoms as measured by the PSS-10 (t39=2.00; P=.05) for all participants postintervention. Participants also improved significantly in the describing and nonjudging facets, based on their FFMQ subscale scores, and asked for some improvements in the user experience with the chatbot. Conclusions: This study shows the benefit of deploying a digital healthy-coping intervention via a chatbot to support university students experiencing higher levels of distress. While findings collected during the COVID-19 pandemic show promise, further research is required to confirm conclusions. %M 33950849 %R 10.2196/27965 %U https://mhealth.jmir.org/2021/5/e27965 %U https://doi.org/10.2196/27965 %U http://www.ncbi.nlm.nih.gov/pubmed/33950849 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 5 %P e29583 %T Olfactory Training and Visual Stimulation Assisted by a Web Application for Patients With Persistent Olfactory Dysfunction After SARS-CoV-2 Infection: Observational Study %A Denis,Fabrice %A Septans,Anne-Lise %A Periers,Lea %A Maillard,Jean-Michel %A Legoff,Florian %A Gurden,Hirac %A Moriniere,Sylvain %+ Institut Inter-Regional Jean Bernard - ELSAN, 9 Rue Beauverger, Le Mans, France, 33 684190480, fabrice.denis.home@gmail.com %K olfactory dysfunction %K SARS-CoV-2 %K olfactory training %K web application, eHealth %K real-life study %K COVID-19 %K app %K training %K stimulation %K olfactory %K dysfunction %K smell %K observational %K senses %K nose %D 2021 %7 27.5.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Persistent olfactory dysfunction is a significant complication of SARS-CoV-2 infection. Olfactory training involving aromatic oils has been recommended to improve olfactory recovery, but quantitative data are missing. Objective: We aimed to quantify the benefit of olfactory training and visual stimulation assisted by a dedicated web application for patients who experienced olfactory dysfunction for ≥1 month. Methods: We performed an observational, real-life, data-based study on a cohort of patients who experienced at least 1 month of persistent olfactory dysfunction between January 30 and March 26, 2021. An analysis was performed after a mean olfactory training time of 4 weeks, and at least 500 patients were assessable for primary outcome assessment. Participants exposed themselves twice daily to odors from 4 high-concentration oils and visual stimulation assisted by a dedicated web application. Improvement was defined as a 2-point increase on a 10-point, self-assessed olfactory visual analogue scale. Results: In total, 548 patients were assessable for primary outcome assessment. The mean baseline, self-assessed olfactory score was 1.9 (SD 1.7), and this increased to 4.6 (SD 2.8) after a mean olfactory training time of 27.7 days (SD 17.2). Olfactory training was associated with at least a 2-point increase in 64.2% (352/548) of patients. The rate of patients’ olfactory improvement was higher for patients who trained for more than 28 days than that rate for patients who trained for less than 28 days (73.3% vs 59%; P=.002). The time to olfactory improvement was 8 days faster for patients with hyposmia compared to the time to improvement for patients with anosmia (P<.001). This benefit was observed regardless of the duration of the olfactory dysfunction. Conclusions: Olfactory training and visual stimulation assisted by a dedicated web application was associated with significant improvement in olfaction, especially after 28 days of olfactory training. %M 34003765 %R 10.2196/29583 %U https://www.jmir.org/2021/5/e29583 %U https://doi.org/10.2196/29583 %U http://www.ncbi.nlm.nih.gov/pubmed/34003765 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 5 %P e24417 %T Recorded Mental Health Recovery Narratives as a Resource for People Affected by Mental Health Problems: Development of the Narrative Experiences Online (NEON) Intervention %A Slade,Mike %A Rennick-Egglestone,Stefan %A Llewellyn-Beardsley,Joy %A Yeo,Caroline %A Roe,James %A Bailey,Sylvia %A Smith,Roger Andrew %A Booth,Susie %A Harrison,Julian %A Bhogal,Adaresh %A Penas Morán,Patricia %A Hui,Ada %A Quadri,Dania %A Robinson,Clare %A Smuk,Melanie %A Farkas,Marianne %A Davidson,Larry %A van der Krieke,Lian %A Slade,Emily %A Bond,Carmel %A Nicholson,Joe %A Grundy,Andrew %A Charles,Ashleigh %A Hare-Duke,Laurie %A Pollock,Kristian %A Ng,Fiona %+ School of Health Sciences, Institute of Mental Health, University of Nottingham, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, United Kingdom, 44 115 409326, stefan.egglestone@nottingham.ac.uk %K narratives %K storytelling %K intervention development %K mental health %K online intervention %K patient involvement %K narrative medicine %K internet %K recovery %K mobile phone %D 2021 %7 27.5.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: The internet enables sharing of narratives about health concerns on a substantial scale, and some digital health narratives have been integrated into digital health interventions. Narratives describing recovery from health problems are a focus of research, including those presented in recorded (eg, invariant) form. No clinical trial has been conducted on a web-based intervention providing access to a collection of Recorded Recovery Narratives (RRNs). Objective: This study presents knowledge produced through the development of the Narrative Experiences Online (NEON) Intervention, a web-based intervention incorporating the algorithmic recommendation of RRNs. Methods: Knowledge was gathered through knowledge integration (KI) activities. KI1 synthesized previous studies to produce the NEON Impact Model describing how accessing RRNs produces health-related outcomes. KI2 developed curation principles for the NEON Collection of RRNs through consultation with the NEON Lived Experience Advisory Panel and the curation of a preliminary collection. KI3 identified harm minimization strategies for the NEON Intervention through consultation with the NEON International Advisory Board and Lived Experience Advisory Panel. The NEON Intervention was finalized through 2 research studies (RS). In RS1, mental health service users (N=40) rated the immediate impact of randomly presented narratives to validate narrative feedback questions used to inform the recommendation algorithm. In RS2, mental health service users (n=25) were interviewed about their immediate response to a prototype of the NEON Intervention and trial procedures and then were interviewed again after 1 month of use. The usability and acceptability of the prototype and trial procedures were evaluated and refinements were made. Results: KI1 produced the NEON Impact Model, which identifies moderators (recipient and context), mechanisms of connection (reflection, comparison, learning, and empathy), processes (identification of change from narrative structure or content and internalization of observed change), and outcomes (helpful and unhelpful). KI2 identified 22 curation principles, including a mission to build a large, heterogeneous collection to maximize opportunities for connection. KI3 identified seven harm minimization strategies, including content warnings, proactive and reactive blocking of narratives, and providing resources for the self-management of emotional distress. RS1 found variation in the impact of narratives on different participants, indicating that participant-level feedback on individual narratives is needed to inform a recommender system. The order of presentation did not predict narrative feedback. RS2 identified amendments to web-based trial procedures and the NEON Intervention. Participants accessed some narratives multiple times, use reduced over the 4-week period, and narrative feedback was provided for 31.8% (105/330) of narrative accesses. Conclusions: RRNs can be integrated into web-based interventions. Evaluating the NEON Intervention in a clinical trial is feasible. The mixed methods design for developing the NEON Intervention can guide its extension to other clinical populations, the design of other web-based mental health interventions, and the development of narrative-based interventions in mental health. %M 34042595 %R 10.2196/24417 %U https://formative.jmir.org/2021/5/e24417 %U https://doi.org/10.2196/24417 %U http://www.ncbi.nlm.nih.gov/pubmed/34042595 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 5 %P e27772 %T Determining the Efficacy of Electronic Cognitive Behavioral Therapy for Generalized Anxiety Disorder Compared to Pharmaceutical Interventions: Protocol for a Quasi-Experimental Study %A Alavi,Nazanin %A Stephenson,Callum %A Yang,Megan %A Shirazi,Amirhossein %A Shao,Yijia %A Kumar,Anchan %A Yee,Caitlin S %A Miller,Shadé %A Stefatos,Anthi %A Gholamzadehmir,Maedeh %A Abbaspour,Zara %A Patel,Archana %A Patel,Charmy %A Reshetukha,Taras %A Omrani,Mohsen %A Groll,Dianne %+ Department of Psychiatry, Queen's University, Hotel Dieu Hospital, 166 Brock Street, Kingston, ON, K7L 5G2, Canada, 1 6135443310, nazanin.alavi@queensu.ca %K eHealth %K mental health %K anxiety %K generalized anxiety disorder %K cognitive behavioral therapy %K psychotherapy %K online %K internet %K electronic %K virtual %K mental health care %D 2021 %7 27.5.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Generalized anxiety disorder (GAD) is an extremely prevalent and debilitating mental health disorder. Currently, the gold standard treatment for GAD is cognitive behavioral therapy (CBT) and/or pharmacotherapy. The most common medications used to treat GAD are selective serotonin reuptake inhibitors and selective norepinephrine reuptake inhibitors. While CBT is the gold standard treatment for GAD, it is costly, time-consuming, and often inaccessible. Fortunately, the electronic delivery of CBT (e-CBT) has emerged as a promising solution to address these barriers. e-CBT has shown to offer comparable results to in-person CBT while improving accessibility for patients and time efficiency for clinicians. Objective: This study aims to investigate the treatment efficacy of e-CBT compared to and in conjunction with pharmacotherapy for GAD. Methods: This study will use a quasi-experimental design to allow patients the freedom to choose which treatment modality they would like to receive. Participants with a diagnosis of GAD will be enrolled in 1 of 3 possible treatment arms: (1) e-CBT, (2) medication, or (3) a combination of e-CBT and medication. The e-CBT program will include a 12-week psychotherapy program delivered through the Online Psychotherapy Tool—a secure, cloud-based, digital mental health platform. The treatment efficacy of e-CBT will be compared with that of medication alone and medication in combination with e-CBT. Results: The study received ethics approval in April 2019 and participant recruitment began in June 2019. Participant recruitment has been conducted through social media advertisements, physical advertisements, and physician referrals. To date, 146 participants (e-CBT: n=53; medication: n=49; combination: n=44) have been recruited. Data collection is expected to conclude by June 2021, and data analysis is expected to be completed by October 2021. Linear regression (for continuous outcomes) and binomial regression (for categorical outcomes) analysis will be conducted using interpretive qualitative methods. Conclusions: If either the efficacy of e-CBT is shown to be comparable to that of medication or the effects of both treatments are augmented when used in tandem, these findings could have major implications on the mental health care system. e-CBT is a more accessible and affordable treatment that could increase mental health care capacity 4-fold if proven viable. Trial Registration: ClinicalTrials.gov NCT04478526; https://clinicaltrials.gov/ct2/show/NCT04478526 International Registered Report Identifier (IRRID): DERR1-10.2196/27772 %M 33857917 %R 10.2196/27772 %U https://www.researchprotocols.org/2021/5/e27772 %U https://doi.org/10.2196/27772 %U http://www.ncbi.nlm.nih.gov/pubmed/33857917 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 5 %P e26643 %T Personalization of Conversational Agent-Patient Interaction Styles for Chronic Disease Management: Two Consecutive Cross-sectional Questionnaire Studies %A Gross,Christoph %A Schachner,Theresa %A Hasl,Andrea %A Kohlbrenner,Dario %A Clarenbach,Christian F %A Wangenheim,Forian V %A Kowatsch,Tobias %+ Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, Zurich, 8006, Switzerland, 41 44 632 03 67, tschachner@ethz.ch %K conversational agents %K chatbots %K human-computer interaction %K physician-patient interaction styles %K deliberative interaction %K paternalistic interaction %K digital health %K chronic conditions %K disease management %K COPD %K chronic obstructive pulmonary disease %D 2021 %7 26.5.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Conversational agents (CAs) for chronic disease management are receiving increasing attention in academia and the industry. However, long-term adherence to CAs is still a challenge and needs to be explored. Personalization of CAs has the potential to improve long-term adherence and, with it, user satisfaction, task efficiency, perceived benefits, and intended behavior change. Research on personalized CAs has already addressed different aspects, such as personalized recommendations and anthropomorphic cues. However, detailed information on interaction styles between patients and CAs in the role of medical health care professionals is scant. Such interaction styles play essential roles for patient satisfaction, treatment adherence, and outcome, as has been shown for physician-patient interactions. Currently, it is not clear (1) whether chronically ill patients prefer a CA with a paternalistic, informative, interpretive, or deliberative interaction style, and (2) which factors influence these preferences. Objective: We aimed to investigate the preferences of chronically ill patients for CA-delivered interaction styles. Methods: We conducted two studies. The first study included a paper-based approach and explored the preferences of chronic obstructive pulmonary disease (COPD) patients for paternalistic, informative, interpretive, and deliberative CA-delivered interaction styles. Based on these results, a second study assessed the effects of the paternalistic and deliberative interaction styles on the relationship quality between the CA and patients via hierarchical multiple linear regression analyses in an online experiment with COPD patients. Patients’ sociodemographic and disease-specific characteristics served as moderator variables. Results: Study 1 with 117 COPD patients revealed a preference for the deliberative (50/117) and informative (34/117) interaction styles across demographic characteristics. All patients who preferred the paternalistic style over the other interaction styles had more severe COPD (three patients, Global Initiative for Chronic Obstructive Lung Disease class 3 or 4). In Study 2 with 123 newly recruited COPD patients, younger participants and participants with a less recent COPD diagnosis scored higher on interaction-related outcomes when interacting with a CA that delivered the deliberative interaction style (interaction between age and CA type: relationship quality: b=−0.77, 95% CI −1.37 to −0.18; intention to continue interaction: b=−0.49, 95% CI −0.97 to −0.01; working alliance attachment bond: b=−0.65, 95% CI −1.26 to −0.04; working alliance goal agreement: b=−0.59, 95% CI −1.18 to −0.01; interaction between recency of COPD diagnosis and CA type: working alliance goal agreement: b=0.57, 95% CI 0.01 to 1.13). Conclusions: Our results indicate that age and a patient’s personal disease experience inform which CA interaction style the patient should be paired with to achieve increased interaction-related outcomes with the CA. These results allow the design of personalized health care CAs with the goal to increase long-term adherence to health-promoting behavior. %M 33913814 %R 10.2196/26643 %U https://www.jmir.org/2021/5/e26643 %U https://doi.org/10.2196/26643 %U http://www.ncbi.nlm.nih.gov/pubmed/33913814 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 5 %P e24190 %T Mobile Apps to Improve Medication Adherence in Cardiovascular Disease: Systematic Review and Meta-analysis %A Al-Arkee,Shahd %A Mason,Julie %A Lane,Deirdre A %A Fabritz,Larissa %A Chua,Winnie %A Haque,M Sayeed %A Jalal,Zahraa %+ Institute of Clinical Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, United Kingdom, 44 0121 414 4042, s.k.k.al-arkee@pgr.bham.ac.uk %K mobile health care applications %K medication adherence %K cardiovascular disease %K systematic review %K mobile phone %D 2021 %7 25.5.2021 %9 Review %J J Med Internet Res %G English %X Background: Adherence rates of preventative medication for cardiovascular disease (CVD) have been reported as 57%, and approximately 9% of all CVD events in Europe are attributable to poor medication adherence. Mobile health technologies, particularly mobile apps, have the potential to improve medication adherence and clinical outcomes. Objective: The objective of this study is to assess the effects of mobile health care apps on medication adherence and health-related outcomes in patients with CVD. This study also evaluates apps’ functionality and usability and the involvement of health care professionals in their use. Methods: Electronic databases (MEDLINE [Ovid], PubMed Central, Cochrane Library, CINAHL Plus, PsycINFO [Ovid], Embase [Ovid], and Google Scholar) were searched for randomized controlled trials (RCTs) to investigate app-based interventions aimed at improving medication adherence in patients with CVD. RCTs published in English from inception to January 2020 were reviewed. The Cochrane risk of bias tool was used to assess the included studies. Meta-analysis was performed for clinical outcomes and medication adherence, with meta-regression analysis used to evaluate the impact of app intervention duration on medication adherence. Results: This study included 16 RCTs published within the last 6 years. In total, 12 RCTs reported medication adherence as the primary outcome, which is the most commonly self-reported adherence. The duration of the interventions ranged from 1 to 12 months, and sample sizes ranged from 24 to 412. Medication adherence rates showed statistically significant improvements in 9 RCTs when compared with the control, and meta-analysis of the 6 RCTs reporting continuous data showed a significant overall effect in favor of the app intervention (mean difference 0.90, 95% CI 0.03-1.78) with a high statistical heterogeneity (I2=93.32%). Moreover, 9 RCTs assessed clinical outcomes and reported an improvement in systolic blood pressure, diastolic blood pressure, total cholesterol, and low-density lipoprotein cholesterol levels in the intervention arm. Meta-analysis of these clinical outcomes from 6 RCTs favored app interventions, but none were significant. In the 7 trials evaluating app usability, all were found to be acceptable. There was a great variation in the app characteristics. A total of 10 RCTs involved health care professionals, mainly physicians and nurses, in the app-based interventions. The apps had mixed functionality: 2 used education, 7 delivered reminders, and 7 provided reminders in combination with educational support. Conclusions: Apps tended to increase medication adherence, but interventions varied widely in design, content, and delivery. Apps have an acceptable degree of usability; yet the app characteristics conferring usability and effectiveness are ill-defined. Future large-scale studies should focus on identifying the essential active components of successful apps. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42019121385; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=121385 %M 34032583 %R 10.2196/24190 %U https://www.jmir.org/2021/5/e24190 %U https://doi.org/10.2196/24190 %U http://www.ncbi.nlm.nih.gov/pubmed/34032583 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 5 %P e25955 %T Evaluation of the My Diabetes Care Patient Portal Intervention: Protocol for a Pilot Randomized Controlled Trial %A Martinez,William %A Hackstadt,Amber J %A Hickson,Gerald B %A Rosenbloom,S Trent %A Elasy,Tom A %+ Department of Medicine, Vanderbilt University Medical Center, 2525 West End Avenue, Nashville, TN, 37203, United States, 1 615 936 1010, william.martinez@vumc.org %K patient portals %K self-management %K patient activation %K diabetes mellitus %K type 2 %K health literacy %K health knowledge %K attitudes %K practice %K mobile phone %D 2021 %7 25.5.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: My Diabetes Care (MDC) is a multi-faceted intervention embedded within an established patient portal, My Health at Vanderbilt. MDC is designed to help patients better understand their diabetes health data and support self-care. MDC uses infographics to visualize and summarize patients’ diabetes health data, incorporates motivational strategies, provides literacy-level appropriate educational resources, and links to a diabetes online patient support community and diabetes news feeds. Objective: This study aims to evaluate the effects of MDC on patient activation in adult patients with type 2 diabetes mellitus. Moreover, we plan to assess secondary outcomes, including system use and usability, and the effects of MDC on cognitive and behavioral outcomes (eg, self-care and self-efficacy). Methods: We are conducting a 6-month, 2-arm, parallel-design, pragmatic pilot randomized controlled trial of the effect of MDC on patient activation. Adult patients with type 2 diabetes mellitus are recruited from primary care clinics affiliated with Vanderbilt University Medical Center. Participants are eligible for the study if they are currently being treated with at least one diabetes medication, are able to speak and read in English, are 21 years or older, and have an existing My Health at Vanderbilt account and reliable access to a desktop or laptop computer with internet access. We exclude patients living in long-term care facilities, patients with known cognitive deficits or severe visual impairment, and patients currently participating in any other diabetes-related research study. Participants are randomly assigned to MDC or usual care. We collect self-reported survey data, including the Patient Activation Measure (R) at baseline, 3 months, and 6 months. We will use mixed-effects regression models to estimate potentially time-varying intervention effects while adjusting for the baseline measure of the outcome. The mixed-effects model will use fixed effects for patient-level characteristics and random effects for health care provider variables (eg, primary care physicians). Results: This study is ongoing. Recruitment was closed in May 2020; 270 patients were randomized. Of those randomized, most (214/267, 80.1%) were non-Hispanic White, and 13.1% (35/267) were non-Hispanic Black, 43.7% (118/270) reported being 65 years or older, and 33.6% (90/268) reported limited health literacy. We obtained at least 95.6% (258/270) completion among participants through the 3-month follow-up assessment. Conclusions: This randomized controlled trial will be one of the first to evaluate a patient-facing diabetes digital health intervention delivered via a patient portal. By embedding MDC into Epic’s MyChart platform with more than 127 million patient records, our intervention is directly integrated into routine care, highly scalable, and sustainable. Our findings and evolving patient portal functionality will inform the continued development of MDC to best meet users’ needs and a larger trial focused on the impact of MDC on clinical end points. Trial Registration: ClinicalTrials.gov NCT03947333; https://clinicaltrials.gov/ct2/show/NCT03947333 International Registered Report Identifier (IRRID): DERR1-10.2196/25955 %M 34032578 %R 10.2196/25955 %U https://www.researchprotocols.org/2021/5/e25955 %U https://doi.org/10.2196/25955 %U http://www.ncbi.nlm.nih.gov/pubmed/34032578 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 5 %P e28221 %T Intelligent Personalized Exercise Prescription Based on an eHealth Promotion System to Improve Health Outcomes of Middle-Aged and Older Adult Community Dwellers: Pretest–Posttest Study %A Sun,Ting %A Xu,Yang %A Xie,Hui %A Ma,Zuchang %A Wang,Yu %+ Anhui Province Key Laboratory of Medical Physics and Technology, Institute of Intelligent Machines, Hefei Institutes of Physical Sciences, Chinese Academy of Sciences, 350# Shushan Lake Rode, Hefei, 230031, China, 86 0551 65591104, ZCMa121@126.com %K exercise prescription %K cardiovascular function %K body composition %K bone mineral density %K physical fitness %D 2021 %7 24.5.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: A scientific, personalized, and quantitative exercise prescription that has the potential to be an important therapeutic agent for all ages in the prevention of chronic disease is highly recommended. However, it is often poorly implemented, as clinicians lack the necessary knowledge and skills while participants have low adherence due to design defects (eg, prescriptions fail to take individual willingness, the appeal of exercise, and complex physical conditions into account). Intelligent personalized prescription is thus worth exploring. Objective: The aim of this study was to investigate whether a year-long cloud platform–based and intelligent personalized exercise prescription intervention could improve Chinese middle-aged and older adult community dwellers’ health outcomes. Methods: A total of 177 participants (aged 52-85 years; mean 67.93, SD 7.05) were recruited from 2 Chinese community health service centers in Anhui Province, China. The exercise intervention was delivered over 12 months with a single-group pretest–posttest design. After being assessed in terms of physical activity, health-related lifestyle, history of chronic diseases and drug use, family history of disease and cardiovascular function, body composition, bone mineral density, and physical fitness through an eHealth promotion system, participants with relative contraindications for exercise were personally prescribed the health care exercise mode by an intelligent system, while those without relative contraindication and who had a regular exercise habit were prescribed the scientific fitness mode. Paired t tests were used for the analysis. Results: A total of 97 participants were classified into the health care mode, and the remaining 80 participants were assigned to the scientific fitness mode. Significant changes in heart rate (mean difference [MD] 2.97; 95% CI 1.1-4.84; P=.002), subendocardial viability ratio (MD –0.13; CI: –1.19 to –0.63; P<.001), weight (MD 0.99; CI 0.29-1.69; P=.006), BMI (MD 0.38; CI 0.11-0.64; P=.006), body fat rate (MD 0.88; CI 0.24-1.51; P=.007), fat mass (MD 0.92; CI 0.33-1.53; P=.003), and brachial-ankle pulse wave velocity (MD: –0.72; CI –1.17 to –0.27; P=.002) were observed among participants with the health care mode exercise prescriptions at the 12-month postintervention versus the baseline assessment, while no changes in systolic blood pressure, diastolic blood pressure, muscle mass, bone mineral density, t value, z value, balance, or ability were discerned. The results showed a functional decline in the physical fitness of both groups, including in handgrip strength (healthcare mode: MD 4.41; scientific fitness mode: MD 3.11), vital capacity (healthcare mode: MD 261.99; scientific fitness mode: MD 250.78), and agility (healthcare mode MD=–0.35; scientific fitness mode: MD=–0.39) with all P values <.001, except handgrip strength in the scientific fitness mode (P=.002). There were no significant differences in other parameters among participants with scientific fitness mode exercise prescriptions. Conclusions: The observations suggest that our exercise prescription intervention program might promote certain health outcomes in Chinese middle-aged and older adult community dwellers, yet we are unable to recommend such a program given the existing limitations. Future randomized controlled trials with diverse samples are warranted to confirm our findings. %M 34028359 %R 10.2196/28221 %U https://www.jmir.org/2021/5/e28221 %U https://doi.org/10.2196/28221 %U http://www.ncbi.nlm.nih.gov/pubmed/34028359 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 5 %P e25609 %T Guided Internet-Based Cognitive Behavioral Therapy for Insomnia: Health-Economic Evaluation From the Societal and Public Health Care Perspective Alongside a Randomized Controlled Trial %A Buntrock,Claudia %A Lehr,Dirk %A Smit,Filip %A Horvath,Hanne %A Berking,Matthias %A Spiegelhalder,Kai %A Riper,Heleen %A Ebert,David Daniel %+ Chair of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nuremberg, Nägelsbachstr 25a, Erlangen, 91052, Germany, 49 09131 8567568, claudia.buntrock@fau.de %K insomnia %K internet-based cognitive behavioural therapy %K iCBT-I %K economic evaluation %K cost-effectiveness %K cost-utility %K cognitive behavioral therapy %K behavior %K sleep %K economics %K public health %K perspective %D 2021 %7 24.5.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The evidence base for internet-based cognitive behavioral therapy for insomnia (iCBT-I) is firm; however, little is known about iCBT-I’s health-economic effects. Objective: This study aimed to evaluate the cost-effectiveness and cost–utility of iCBT-I in reducing insomnia among schoolteachers. Methods: Schoolteachers (N=128) with clinically significant insomnia symptoms and work-related rumination were randomized to guided iCBT-I or a wait list control group, both with unrestricted access to treatment as usual. Health care use, patient and family expenditures, and productivity losses were self-assessed and used for costing from a societal and a public health care perspective. Costs were related to symptom-free status (score <8 on the insomnia severity index) and quality-adjusted life years (QALYs) gained. Sampling error was handled using nonparametric bootstrapping. Results: Statistically significant differences favoring the intervention group were found for both health outcomes (symptom-free status yes or no: β=.30; 95% CI 0.16-0.43; QALYs: β=.019, 95% CI 0.01-0.03). From a societal perspective, iCBT-I had a 94% probability of dominating the wait list control for both health outcomes. From a public health care perspective, iCBT-I was more effective but also more expensive than the wait list control, resulting in an incremental cost-effectiveness ratio of €650 per symptom-free individual. In terms of QALYs, the incremental cost-effectiveness ratio was €11,285. At a willingness-to-pay threshold of €20,000 per QALY gained, the intervention’s probability of being cost-effective was 89%. Conclusions: Our trial indicates that iCBT could be considered as a good value-for-money intervention for insomnia. Trial Registration: German Clinical Trial Registry: DRKS00004700; https://tinyurl.com/2nnk57jm International Registered Report Identifier (IRRID): RR2-10.1186/1745-6215-14-169 %M 34028361 %R 10.2196/25609 %U https://www.jmir.org/2021/5/e25609 %U https://doi.org/10.2196/25609 %U http://www.ncbi.nlm.nih.gov/pubmed/34028361 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 5 %P e25465 %T Internet-Based Cognitive Behavioral Therapy for Patients Reporting Symptoms of Anxiety and Depression After Myocardial Infarction: U-CARE Heart Randomized Controlled Trial Twelve-Month Follow-up %A Humphries,Sophia Monica %A Wallert,John %A Norlund,Fredrika %A Wallin,Emma %A Burell,Gunilla %A von Essen,Louise %A Held,Claes %A Olsson,Erik Martin Gustaf %+ Clinical Psychology in Healthcare, Department of Women's and Children's Health, Uppsala University, Akademiska Hospital, Uppsala, 75185, Sweden, 46 760341186, sophia.humphries@kbh.uu.se %K myocardial infarction %K iCBT %K psychological treatment %K cardiovascular health %K cognitive behavior therapy %K internet %K cardiovascular %K infarction %K treatment %K anxiety %K depression %D 2021 %7 24.5.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The U-CARE Heart trial was one of the first randomized controlled trials to evaluate the effect of internet-based cognitive behavioral therapy on self-reported symptoms of anxiety or depression for patients with a recent myocardial infarction. While the effects of internet-based cognitive behavioral therapy on Hospital Anxiety and Depression Scale (HADS) scores at 14 weeks postbaseline were not significant, in this study, we investigated possible long-term effects of treatment. Objective: The aim of this study was to evaluate the long-term effectiveness of internet-based cognitive behavioral therapy on self-reported symptoms of anxiety and depression in patients 12 months after a myocardial infarction and to explore subsequent occurrences of cardiovascular disease events. Methods: Shortly after acute myocardial infarction, 239 patients (33% female, mean age 59.6 years) reporting mild-to-moderate symptoms of anxiety or depression were randomized to 14 weeks of therapist-guided internet-based cognitive behavioral therapy (n=117) or treatment as usual (n=122). Data from national registries were used to explore group differences in clinical outcomes such as cardiovascular disease and cardiovascular-related mortality for a follow-up period of up to 5 years: group differences in HADS total score 1 year post–myocardial infarction, the primary outcome, was analyzed using multiple linear regression. Secondary outcomes, such as HADS anxiety and depression subscales and the Cardiac Anxiety Questionnaire total score (CAQ), which measures heart-focused anxiety, were analyzed in the same way. Multiple imputation was used to account for missing data, and a pooled treatment effect was estimated. Adjusted Cox proportional hazards models were used to estimate hazard ratios (HRs) for data pertaining to registry outcomes. Results: Both groups reported lower HADS total scores 1 year after myocardial infarction than those at baseline. HADS total scores were not significantly different between the treatment and control groups 1 year after myocardial infarction (β=–1.14, 95% CI –2.73 to 0.45, P=.16). CAQ was the only measure improved significantly by internet-based cognitive behavioral therapy when compared with treatment as usual (β=–2.58, 95% CI –4.75 to –0.42, P=.02) before adjusting for multiple comparisons. The composite outcome of nonfatal cardiovascular events and cardiovascular-related mortality did not differ between groups but was numerically higher in the internet-based cognitive behavioral therapy group, who were at slightly greater risk (HR 1.8, 95% CI 0.96 to 3.4, P=.07). Adjusting for previous myocardial infarction and diabetes attenuated this estimate (HR 1.5, 95% CI 0.8 to 2.8, P=.25). Conclusions: Internet-based cognitive behavioral therapy was not superior in reducing self-reported symptoms of depression or anxiety compared to treatment as usual at the 1-year follow-up after myocardial infarction. A reduction in cardiac-related anxiety was observed but was not significant after adjusting for multiple comparisons. There was no difference in risk of cardiovascular events between the treatment groups. Low treatment adherence, which might have affected treatment engagement and outcomes, should be considered when interpreting these results. Trial Registration: ClinicalTrials.gov NCT01504191; https://clinicaltrials.gov/ct2/show/NCT01504191 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-015-0689-y %M 34028358 %R 10.2196/25465 %U https://www.jmir.org/2021/5/e25465 %U https://doi.org/10.2196/25465 %U http://www.ncbi.nlm.nih.gov/pubmed/34028358 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 5 %P e25401 %T Leveraging Genomic Associations in Precision Digital Care for Weight Loss: Cohort Study %A Sinha,Ranjan %A Kachru,Dashyanng %A Ricchetti,Roshni Ray %A Singh-Rambiritch,Simitha %A Muthukumar,Karthik Marimuthu %A Singaravel,Vidhya %A Irudayanathan,Carmel %A Reddy-Sinha,Chandana %A Junaid,Imran %A Sharma,Garima %A Francis-Lyon,Patricia Alice %+ Digbi Health, 13105 Delson Ct, Los Altos, CA, 94022, United States, 1 510 883 3721, patricia@digbihealth.com %K obesity %K digital therapeutics %K precision nutrition %K nutrigenomics %K personalized nutrition %K mHealth %K mobile apps %K gut microbiota %K machine learning %K health coaching %K lifestyle medicine %K mobile phone %D 2021 %7 19.5.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The COVID-19 pandemic has highlighted the urgency of addressing an epidemic of obesity and associated inflammatory illnesses. Previous studies have demonstrated that interactions between single-nucleotide polymorphisms (SNPs) and lifestyle interventions such as food and exercise may vary metabolic outcomes, contributing to obesity. However, there is a paucity of research relating outcomes from digital therapeutics to the inclusion of genetic data in care interventions. Objective: This study aims to describe and model the weight loss of participants enrolled in a precision digital weight loss program informed by the machine learning analysis of their data, including genomic data. It was hypothesized that weight loss models would exhibit a better fit when incorporating genomic data versus demographic and engagement variables alone. Methods: A cohort of 393 participants enrolled in Digbi Health’s personalized digital care program for 120 days was analyzed retrospectively. The care protocol used participant data to inform precision coaching by mobile app and personal coach. Linear regression models were fit of weight loss (pounds lost and percentage lost) as a function of demographic and behavioral engagement variables. Genomic-enhanced models were built by adding 197 SNPs from participant genomic data as predictors and refitted using Lasso regression on SNPs for variable selection. Success or failure logistic regression models were also fit with and without genomic data. Results: Overall, 72.0% (n=283) of the 393 participants in this cohort lost weight, whereas 17.3% (n=68) maintained stable weight. A total of 142 participants lost 5% bodyweight within 120 days. Models described the impact of demographic and clinical factors, behavioral engagement, and genomic risk on weight loss. Incorporating genomic predictors improved the mean squared error of weight loss models (pounds lost and percent) from 70 to 60 and 16 to 13, respectively. The logistic model improved the pseudo R2 value from 0.193 to 0.285. Gender, engagement, and specific SNPs were significantly associated with weight loss. SNPs within genes involved in metabolic pathways processing food and regulating fat storage were associated with weight loss in this cohort: rs17300539_G (insulin resistance and monounsaturated fat metabolism), rs2016520_C (BMI, waist circumference, and cholesterol metabolism), and rs4074995_A (calcium-potassium transport and serum calcium levels). The models described greater average weight loss for participants with more risk alleles. Notably, coaching for dietary modification was personalized to these genetic risks. Conclusions: Including genomic information when modeling outcomes of a digital precision weight loss program greatly enhanced the model accuracy. Interpretable weight loss models indicated the efficacy of coaching informed by participants’ genomic risk, accompanied by active engagement of participants in their own success. Although large-scale validation is needed, our study preliminarily supports precision dietary interventions for weight loss using genetic risk, with digitally delivered recommendations alongside health coaching to improve intervention efficacy. %M 33849843 %R 10.2196/25401 %U https://www.jmir.org/2021/5/e25401 %U https://doi.org/10.2196/25401 %U http://www.ncbi.nlm.nih.gov/pubmed/33849843 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 5 %P e15649 %T Effectiveness of eHealth Nutritional Interventions for Middle-Aged and Older Adults: Systematic Review and Meta-analysis %A Robert,Caroline %A Erdt,Mojisola %A Lee,James %A Cao,Yuanyuan %A Naharudin,Nurhazimah Binte %A Theng,Yin-Leng %+ Wee Kim Wee School of Communication and Information, Nanyang Technological University, 31 Nanyang Link, Singapore, 637331, Singapore, 65 69083444, carolinerobertjong@gmail.com %K eHealth %K mHealth %K nutritional intervention %K nutrition apps %K middle-aged %K older adults %K systematic review %K meta-analysis %D 2021 %7 17.5.2021 %9 Review %J J Med Internet Res %G English %X Background: The risk of development of chronic diseases related to poor nutrition increases with age. In the face of an aging population, it is important for health care sectors to find solutions in delivering health services efficiently and effectively to middle-aged and older adults. Objective: The aim of this systematic review and meta-analysis was to consolidate the literature that reported the effectiveness of eHealth apps in delivering nutritional interventions for middle-aged and older adults. Methods: A literature search from five databases (PubMed, CINAHL, Cochrane, Web of Science, and Global Health) from the past 5 years was performed. Studies were selected for inclusion that used eHealth to deliver nutritional interventions to adults aged 40 years and above, and reported health and behavioral outcomes. Two independent reviewers searched for research articles and assessed the eligibility of studies to be included in the review. A third reviewer resolved disagreements on study inclusion. We also assessed the quality of the included studies using the CONSORT 2010 checklist. Results: A total of 70 studies were included for analysis. The study quality ranged from 44% to 85%. The most commonly used eHealth intervention type was mobile apps (22/70, 31%). The majority of studies (62/70, 89%) provided multicomponent health interventions, which aimed to improve nutrition and other health behaviors (eg, exercise, smoking cessation, medication adherence). Meta-analysis results indicated high and significant heterogeneity; hence, conclusions based on these results should be considered with caution. Nonetheless, the results generally showed that eHealth interventions improved anthropometric and clinical outcomes, but not behavioral outcomes such as fruit and vegetable consumption. Conclusions: The use of eHealth apps to deliver health interventions has been increasing in recent years, and these apps have the potential to deliver health services to a larger group of people. Our findings showed that the effectiveness of eHealth apps to deliver health interventions for middle-aged to older adults was supported by the improvement of anthropometric and clinical outcomes. Future work could aim to develop research frameworks in administering eHealth interventions to address heterogeneity in this field of research. %M 33999005 %R 10.2196/15649 %U https://www.jmir.org/2021/5/e15649 %U https://doi.org/10.2196/15649 %U http://www.ncbi.nlm.nih.gov/pubmed/33999005 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 5 %P e27088 %T Effects of Providing Tailored Information About e-Cigarettes in a Web-Based Smoking Cessation Intervention: Protocol for a Randomized Controlled Trial %A Elling,Jan Mathis %A Crutzen,Rik %A Talhout,Reinskje %A de Vries,Hein %+ Department of Health Promotion, Maastricht University/CAPHRI, P Debyeplein 1, Maastricht, 6229 HA, Netherlands, 31 433882425, m.elling@maastrichtuniversity.nl %K digital health %K eHealth %K mHealth %K electronic cigarette %K e-cigarette %K electronic nicotine delivery system %K ENDS %K smoking %K smoking cessation %K computer tailoring %D 2021 %7 14.5.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: There is an ongoing debate whether electronic cigarettes (e-cigarettes) should be advocated for smoking cessation. Because of this uncertainty, information about the use of e-cigarettes for smoking cessation is usually not provided in governmental smoking cessation communications. However, there is an information need among smokers because despite this uncertainty, e-cigarettes are used by many smokers to reduce and quit tobacco smoking. Objective: The aim of this study is to describe the protocol of a randomized controlled trial that assesses the effect of providing tailored information about e-cigarettes compared to not providing this information on determinants of decision making and smoking reduction and abstinence. This information is provided in the context of a digital smoking cessation intervention. Methods: A randomized controlled trial with a 6-month follow-up period will be conducted among adult smokers motivated to quit smoking within 5 years. Participants will be 1:1 randomized into either the intervention condition or control condition. In this trial, which is grounded on the I-Change model, participants in both conditions will receive tailored feedback on attitude, social influence, preparatory plans, self-efficacy, and coping plans. Information on 6 clusters of smoking cessation methods (face-to-face counselling, eHealth interventions, telephone counselling, group-based programs, nicotine replacement therapy, and prescription medication) will be provided in both conditions. Smokers in the intervention condition will also receive detailed tailored information on e-cigarettes, while smokers in the control condition will not receive this information. The primary outcome measure will be the number of tobacco cigarettes smoked in the past 7 days. Secondary outcome measures will include 7-day point prevalence tobacco abstinence, 7-day point prevalence e-cigarette abstinence, and determinants of decision making (ie, knowledge and attitude regarding e-cigarettes). All outcomes will be self-assessed through web-based questionnaires. Results: This project is supported by a research grant of the National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu). Ethical approval was granted by the Ethics Review Committee Health, Medicine and Life Sciences at Maastricht University (FHML-REC/2019/072). Recruitment began in March 2020 and was completed by July 2020. We enrolled 492 smokers in this study. The results are expected to be published in June 2021. Conclusions: The experimental design of this study allows conclusions to be formed regarding the effects of tailored information about e-cigarettes on decision making and smoking behavior. Our findings can inform the development of future smoking cessation interventions. Trial Registration: Dutch Trial Register Trial NL8330; https://www.trialregister.nl/trial/8330 International Registered Report Identifier (IRRID): DERR1-10.2196/27088 %M 33988520 %R 10.2196/27088 %U https://www.researchprotocols.org/2021/5/e27088 %U https://doi.org/10.2196/27088 %U http://www.ncbi.nlm.nih.gov/pubmed/33988520 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 5 %P e19688 %T Effectiveness of Digital Interventions for Reducing Behavioral Risks of Cardiovascular Disease in Nonclinical Adult Populations: Systematic Review of Reviews %A Gold,Natalie %A Yau,Amy %A Rigby,Benjamin %A Dyke,Chris %A Remfry,Elizabeth Alice %A Chadborn,Tim %+ Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, United Kingdom, 44 9767839044, n.gold@lse.ac.uk %K alcohol %K behavior change %K cardiovascular disease %K diet %K digital interventions %K digital medicine %K internet interventions %K mHealth %K mobile interventions %K physical activity %K smoking %K tobacco %K mobile phone %D 2021 %7 14.5.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital health interventions are increasingly being used as a supplement or replacement for face-to-face services as a part of predictive prevention. They may be offered to those who are at high risk of cardiovascular disease and need to improve their diet, increase physical activity, stop smoking, or reduce alcohol consumption. Despite the popularity of these interventions, there is no overall summary and comparison of the effectiveness of different modes of delivery of a digital intervention to inform policy. Objective: This review aims to summarize the effectiveness of digital interventions in improving behavioral and health outcomes related to physical activity, smoking, alcohol consumption, or diet in nonclinical adult populations and to identify the effectiveness of different modes of delivery of digital interventions. Methods: We reviewed articles published in the English language between January 1, 2009, and February 25, 2019, that presented a systematic review with a narrative synthesis or meta-analysis of any study design examining digital intervention effectiveness; data related to adults (≥18 years) in high-income countries; and data on behavioral or health outcomes related to diet, physical activity, smoking, or alcohol, alone or in any combination. Any time frame or comparator was considered eligible. We searched MEDLINE, Embase, PsycINFO, Cochrane Reviews, and gray literature. The AMSTAR-2 tool was used to assess review confidence ratings. Results: We found 92 reviews from the academic literature (47 with meta-analyses) and 2 gray literature items (1 with a meta-analysis). Digital interventions were typically more effective than no intervention, but the effect sizes were small. Evidence on the effectiveness of digital interventions compared with face-to-face interventions was mixed. Most trials reported that intent-to-treat analysis and attrition rates were often high. Studies with long follow-up periods were scarce. However, we found that digital interventions may be effective for up to 6 months after the end of the intervention but that the effects dissipated by 12 months. There were small positive effects of digital interventions on smoking cessation and alcohol reduction; possible effectiveness in combined diet and physical activity interventions; no effectiveness for interventions targeting physical activity alone, except for when interventions were delivered by mobile phone, which had medium-sized effects; and no effectiveness observed for interventions targeting diet alone. Mobile interventions were particularly effective. Internet-based interventions were generally effective. Conclusions: Digital interventions have small positive effects on smoking, alcohol consumption, and in interventions that target a combination of diet and physical activity. Small effects may have been due to the low efficacy of treatment or due to nonadherence. In addition, our ability to make inferences from the literature we reviewed was limited as those interventions were heterogeneous, many reviews had critically low AMSTAR-2 ratings, analysis was typically intent-to-treat, and follow-up times were relatively short. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42019126074; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=126074. %M 33988126 %R 10.2196/19688 %U https://www.jmir.org/2021/5/e19688 %U https://doi.org/10.2196/19688 %U http://www.ncbi.nlm.nih.gov/pubmed/33988126 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 5 %P e24494 %T Improving Medication Adherence Through Adaptive Digital Interventions (iMedA) in Patients With Hypertension: Protocol for an Interrupted Time Series Study %A Etminani,Kobra %A Göransson,Carina %A Galozy,Alexander %A Norell Pejner,Margaretha %A Nowaczyk,Sławomir %+ Center for Applied Intelligent Systems Research, Halmstad University, Kristian IV:s väg 3, Halmstad, 30118, Sweden, 46 35167332, kobra.etminani@hh.se %K medication adherence %K hypertension %K digital intervention %K mHealth %K artificial intelligence %D 2021 %7 12.5.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: There is a strong need to improve medication adherence (MA) for individuals with hypertension in order to reduce long-term hospitalization costs. We believe this can be achieved through an artificial intelligence agent that helps the patient in understanding key individual adherence risk factors and designing an appropriate intervention plan. The incidence of hypertension in Sweden is estimated at approximately 27%. Although blood pressure control has increased in Sweden, barely half of the treated patients achieved adequate blood pressure levels. It is a major risk factor for coronary heart disease and stroke as well as heart failure. MA is a key factor for good clinical outcomes in persons with hypertension. Objective: The overall aim of this study is to design, develop, test, and evaluate an adaptive digital intervention called iMedA, delivered via a mobile app to improve MA, self-care management, and blood pressure control for persons with hypertension. Methods: The study design is an interrupted time series. We will collect data on a daily basis, 14 days before, during 6 months of delivering digital interventions through the mobile app, and 14 days after. The effect will be analyzed using segmented regression analysis. The participants will be recruited in Region Halland, Sweden. The design of the digital interventions follows the just-in-time adaptive intervention framework. The primary (distal) outcome is MA, and the secondary outcome is blood pressure. The design of the digital intervention is developed based on a needs assessment process including a systematic review, focus group interviews, and a pilot study, before conducting the longitudinal interrupted time series study. Results: The focus groups of persons with hypertension have been conducted to perform the needs assessment in a Swedish context. The design and development of digital interventions are in progress, and the interventions are planned to be ready in November 2020. Then, the 2-week pilot study for usability evaluation will start, and the interrupted time series study, which we plan to start in February 2021, will follow it. Conclusions: We hypothesize that iMedA will improve medication adherence and self-care management. This study could illustrate how self-care management tools can be an additional (digital) treatment support to a clinical one without increasing burden on health care staff. Trial Registration: ClinicalTrials.gov NCT04413500; https://clinicaltrials.gov/ct2/show/NCT04413500 International Registered Report Identifier (IRRID): DERR1-10.2196/24494 %M 33978593 %R 10.2196/24494 %U https://www.researchprotocols.org/2021/5/e24494 %U https://doi.org/10.2196/24494 %U http://www.ncbi.nlm.nih.gov/pubmed/33978593 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 5 %P e27410 %T Guided Internet-Based Cognitive Behavioral Therapy for Depression: Implementation Cost-Effectiveness Study %A Piera-Jiménez,Jordi %A Etzelmueller,Anne %A Kolovos,Spyros %A Folkvord,Frans %A Lupiáñez-Villanueva,Francisco %+ Open Evidence Research Group, Universitat Oberta de Catalunya, Rambla del Poblenou 156, Barcelona, 08018, Spain, 34 651041515, jpieraj@uoc.edu %K digital health %K telemedicine %K eHealth %K e–mental health %K internet-based cognitive behavioral therapy %K depression %K iCBT %K implementation %K cost-effectiveness %K cognitive behavioral therapy %K CBT %K cost %D 2021 %7 11.5.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Major depressive disorder is a chronic condition; its prevalence is expected to grow with the aging trend of high-income countries. Internet-based cognitive-behavioral therapy has proven efficacy in treating major depressive disorder. Objective: The objective of this study was to assess the cost-effectiveness of implementing a community internet-based cognitive behavioral therapy intervention (Super@, the Spanish program for the MasterMind project) for treating major depressive disorder. Methods: The cost-effectiveness of the Super@ program was assessed with the Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing tool, using a 3-state Markov model. Data from the cost and effectiveness of the intervention were prospectively collected from the implementation of the program by a health care provider in Badalona, Spain; the corresponding data for usual care were gathered from the literature. The health states, transition probabilities, and utilities were computed using Patient Health Questionnaire–9 scores. Results: The analysis was performed using data from 229 participants using the Super@ program. Results showed that the intervention was more costly than usual care; the discounted (3%) and nondiscounted incremental cost-effectiveness ratios were €29,367 and €26,484 per quality-adjusted life-year, respectively (approximately US $35,299 and $31,833, respectively). The intervention was cost-effective based on the €30,000 willingness-to-pay threshold typically applied in Spain (equivalent to approximately $36,060). According to the deterministic sensitivity analyses, the potential reduction of costs associated with intervention scale-up would reduce the incremental cost-effectiveness ratio of the intervention, although it remained more costly than usual care. A discount in the incremental effects up to 5% exceeded the willingness-to-pay threshold of €30,000. Conclusions: The Super@ program, an internet-based cognitive behavioral therapy intervention for treating major depressive disorder, cost more than treatment as usual. Nevertheless, its implementation in Spain would be cost-effective from health care and societal perspectives, given the willingness-to-pay threshold of €30,000 compared with treatment as usual. %M 33973857 %R 10.2196/27410 %U https://www.jmir.org/2021/5/e27410 %U https://doi.org/10.2196/27410 %U http://www.ncbi.nlm.nih.gov/pubmed/33973857 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 5 %P e27610 %T Initial Outcomes of Transdiagnostic Internet-Delivered Cognitive Behavioral Therapy Tailored to Public Safety Personnel: Longitudinal Observational Study %A Hadjistavropoulos,Heather D %A McCall,Hugh C %A Thiessen,David L %A Huang,Ziyin %A Carleton,R Nicholas %A Dear,Blake F %A Titov,Nickolai %+ Department of Psychology, University of Regina, Administration-Humanities Building, AH 345, 3737 Wascana Parkway, Regina, SK, S4S 0A2, Canada, 1 306 585 5133, Heather.Hadjistavropoulos@uregina.ca %K internet %K cognitive behavior therapy %K anxiety %K depression %K posttraumatic stress disorder %K public safety personnel %K CBT %K internet-based cognitive behavioral therapy %K ICBT %K PTSD %K outcome %K diagnosis %K longitudinal %K observational %K literature %K effectiveness %D 2021 %7 5.5.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Canadian public safety personnel (PSP) experience high rates of mental health disorders and face many barriers to treatment. Internet-delivered cognitive behavioral therapy (ICBT) overcomes many such barriers, and is effective for treating depression, anxiety, and posttraumatic stress disorder (PTSD) symptoms. Objective: This study was designed to fill a gap in the literature regarding the use of ICBT tailored specifically for PSP. We examined the effectiveness of a tailored ICBT program for treating depression, anxiety, and PTSD symptoms among PSP in the province of Saskatchewan. Methods: We employed a longitudinal single-group open-trial design (N=83) with outcome measures administered at screening and at 8 weeks posttreatment. Data were collected between December 5, 2019 and September 11, 2020. Primary outcomes included changes in depression, anxiety, and PTSD symptoms. Secondary outcomes included changes in functional impairment; symptoms of panic, social anxiety, and anger; as well as treatment satisfaction, working alliance, and program usage patterns. Results: Clients reported large symptom reductions on measures of depression and anxiety, as well as moderate reductions on measures of PTSD and secondary symptoms, except for social anxiety. Most clients who reported symptoms above clinical cut-offs on measures of depression, anxiety, and PTSD during screening experienced clinically significant symptom reductions. Results suggested good engagement, treatment satisfaction, and working alliance. Conclusions: Tailored, transdiagnostic ICBT demonstrated promising outcomes as a treatment for depression, anxiety, and PTSD among Saskatchewan PSP and warrants further investigation. Trial Registration: Clinicaltrials.gov NCT04127032; https://www.clinicaltrials.gov/ct2/show/NCT04127032 %M 33949959 %R 10.2196/27610 %U https://www.jmir.org/2021/5/e27610 %U https://doi.org/10.2196/27610 %U http://www.ncbi.nlm.nih.gov/pubmed/33949959 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 5 %P e25288 %T Information and Communication Technology Use in Suicide Prevention: Scoping Review %A Rassy,Jessica %A Bardon,Cécile %A Dargis,Luc %A Côté,Louis-Philippe %A Corthésy-Blondin,Laurent %A Mörch,Carl-Maria %A Labelle,Réal %+ Department of Psychology, Université du Québec à Montréal, CP 8888, succ Centre-Ville, Montréal, QC, H3C 3P8, Canada, 1 514 987 4184, labelle.real@uqam.ca %K suicide prevention %K information and communication technology %K scoping review %K mobile phone %D 2021 %7 4.5.2021 %9 Review %J J Med Internet Res %G English %X Background: The use of information and communication technology (ICT) in suicide prevention has progressed rapidly over the past decade. ICT plays a major role in suicide prevention, but research on best and promising practices has been slow. Objective: This paper aims to explore the existing literature on ICT use in suicide prevention to answer the following question: what are the best and most promising ICT practices for suicide prevention? Methods: A scoping search was conducted using the following databases: PubMed, PsycINFO, Sociological Abstracts, and IEEE Xplore. These databases were searched for articles published between January 1, 2013, and December 31, 2018. The five stages of the scoping review process were as follows: identifying research questions; targeting relevant studies; selecting studies; charting data; and collating, summarizing, and reporting the results. The World Health Organization suicide prevention model was used according to the continuum of universal, selective, and indicated prevention. Results: Of the 3848 studies identified, 115 (2.99%) were selected. Of these, 10 regarded the use of ICT in universal suicide prevention, 53 referred to the use of ICT in selective suicide prevention, and 52 dealt with the use of ICT in indicated suicide prevention. Conclusions: The use of ICT plays a major role in suicide prevention, and many promising programs were identified through this scoping review. However, large-scale evaluation studies are needed to further examine the effectiveness of these programs and strategies. In addition, safety and ethics protocols for ICT-based interventions are recommended. %M 33820754 %R 10.2196/25288 %U https://www.jmir.org/2021/5/e25288 %U https://doi.org/10.2196/25288 %U http://www.ncbi.nlm.nih.gov/pubmed/33820754 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e27463 %T CANreduce 2.0 Adherence-Focused Guidance for Internet Self-Help Among Cannabis Users: Three-Arm Randomized Controlled Trial %A Baumgartner,Christian %A Schaub,Michael Patrick %A Wenger,Andreas %A Malischnig,Doris %A Augsburger,Mareike %A Walter,Marc %A Berger,Thomas %A Stark,Lars %A Ebert,David Daniel %A Keough,Matthew T %A Haug,Severin %+ Swiss Research Institute for Public Health and Addiciton, University of Zurich, Konradstrasse 32, Zürich, 8005, Switzerland, 41 444481160, christian.baumgartner@isgf.uzh.ch %K cannabis %K common mental disorders %K adherence %K social presence %K internet %K cognitive behavioral therapy %K motivational interviewing %K therapy %K mental health %K mental disorder %K adherence %K guidance %K self-help %K drug abuse %K randomized controlled trial %D 2021 %7 30.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite increasing demand for treatment among cannabis users in many countries, most users are not in treatment. Internet-based self-help offers an alternative for those hesitant to seek face-to-face therapy, though low effectiveness and adherence issues often arise. Objective: Through adherence-focused guidance enhancement, we aimed to increase adherence to and the effectiveness of internet-based self-help among cannabis users. Methods: From July 2016 to May 2019, cannabis users (n=775; male: 406/575, 70.6%, female: 169/575, 29.4%; age: mean 28.3 years) not in treatment were recruited from the general population and were randomly assigned to (1) an adherence-focused guidance enhancement internet-based self-help intervention with social presence, (2) a similar intervention with an impersonal service team, and (3) access to internet as usual. Controls who were placed on a waiting list for the full intervention after 3 months underwent an assessment and had access to internet as usual. The primary outcome measurement was cannabis-use days over the preceding 30 days. Secondary outcomes included cannabis-dependence severity, changes in common mental disorder symptoms, and intervention adherence. Differences between the study arms in primary and secondary continuous outcome variables at baseline, posttreatment, and follow-up were tested using pooled linear models. Results: All groups exhibited reduced cannabis-use days after 3 months (social presence: –8.2 days; service team: –9.8 days; internet as usual: –4.2 days). The participants in the service team group (P=.01, d=.60) reported significantly fewer cannabis-use days than those in the internet as usual group; the reduction of cannabis use in the social presence group was not significant (P=.07, d=.40). There was no significant difference between the 2 intervention groups regarding cannabis-use reduction. The service team group also exhibited superior improvements in cannabis-use disorder, cannabis-dependence severity, and general anxiety symptoms after 3 months to those in the internet as usual group. Conclusions: The adherence-focused guidance enhancement internet-based self-help intervention with an impersonal service team significantly reduced cannabis use, cannabis-use disorder, dependence severity, and general anxiety symptoms. Trial Registration: ISRCTN Registry ISRCTN11086185; http://www.isrctn.com/ISRCTN11086185 %M 33929333 %R 10.2196/27463 %U https://www.jmir.org/2021/4/e27463 %U https://doi.org/10.2196/27463 %U http://www.ncbi.nlm.nih.gov/pubmed/33929333 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e26699 %T Long-term Effectiveness of mHealth Physical Activity Interventions: Systematic Review and Meta-analysis of Randomized Controlled Trials %A Mönninghoff,Annette %A Kramer,Jan Niklas %A Hess,Alexander Jan %A Ismailova,Kamila %A Teepe,Gisbert W %A Tudor Car,Lorainne %A Müller-Riemenschneider,Falk %A Kowatsch,Tobias %+ Institute for Customer Insight, University of St. Gallen, Bahnhofstrasse 8, St. Gallen, 9000, Switzerland, 41 76 229 3150, Annette.Moenninghoff@unisg.ch %K mHealth %K physical activity %K systematic review %K meta-analysis %K mobile phone %D 2021 %7 30.4.2021 %9 Review %J J Med Internet Res %G English %X Background: Mobile health (mHealth) interventions can increase physical activity (PA); however, their long-term impact is not well understood. Objective: The primary aim of this study is to understand the immediate and long-term effects of mHealth interventions on PA. The secondary aim is to explore potential effect moderators. Methods: We performed this study according to the Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. We searched PubMed, the Cochrane Library, SCOPUS, and PsycINFO in July 2020. Eligible studies included randomized controlled trials of mHealth interventions targeting PA as a primary outcome in adults. Eligible outcome measures were walking, moderate-to-vigorous physical activity (MVPA), total physical activity (TPA), and energy expenditure. Where reported, we extracted data for 3 time points (ie, end of intervention, follow-up ≤6 months, and follow-up >6 months). To explore effect moderators, we performed subgroup analyses by population, intervention design, and control group type. Results were summarized using random effects meta-analysis. Risk of bias was assessed using the Cochrane Collaboration tool. Results: Of the 2828 identified studies, 117 were included. These studies reported on 21,118 participants with a mean age of 52.03 (SD 14.14) years, of whom 58.99% (n=12,459) were female. mHealth interventions significantly increased PA across all the 4 outcome measures at the end of intervention (walking standardized mean difference [SMD] 0.46, 95% CI 0.36-0.55; P<.001; MVPA SMD 0.28, 95% CI 0.21-0.35; P<.001; TPA SMD 0.34, 95% CI 0.20-0.47; P<.001; energy expenditure SMD 0.44, 95% CI 0.13-0.75; P=.01). Only 33 studies reported short-term follow-up measurements, and 8 studies reported long-term follow-up measurements in addition to end-of-intervention results. In the short term, effects were sustained for walking (SMD 0.26, 95% CI 0.09-0.42; P=.002), MVPA (SMD 0.20, 95% CI 0.05-0.35; P=.008), and TPA (SMD 0.53, 95% CI 0.13-0.93; P=.009). In the long term, effects were also sustained for walking (SMD 0.25, 95% CI 0.10-0.39; P=.001) and MVPA (SMD 0.19, 95% CI 0.11-0.27; P<.001). We found the study population to be an effect moderator, with higher effect scores in sick and at-risk populations. PA was increased both in scalable and nonscalable mHealth intervention designs and regardless of the control group type. The risk of bias was rated high in 80.3% (94/117) of the studies. Heterogeneity was significant, resulting in low to very low quality of evidence. Conclusions: mHealth interventions can foster small to moderate increases in PA. The effects are maintained long term; however, the effect size decreases over time. The results encourage using mHealth interventions in at-risk and sick populations and support the use of scalable mHealth intervention designs to affordably reach large populations. However, given the low evidence quality, further methodologically rigorous studies are warranted to evaluate the long-term effects. %M 33811021 %R 10.2196/26699 %U https://www.jmir.org/2021/4/e26699 %U https://doi.org/10.2196/26699 %U http://www.ncbi.nlm.nih.gov/pubmed/33811021 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e25672 %T Experiences and Factors Affecting Usage of an eHealth Tool for Self-Management Among People With Chronic Obstructive Pulmonary Disease: Qualitative Study %A Marklund,Sarah %A Tistad,Malin %A Lundell,Sara %A Östrand,Lina %A Sörlin,Ann %A Boström,Carina %A Wadell,Karin %A Nyberg,Andre %+ Section of Physiotherapy, Department of Community Medicine and Rehabilitation, Umeå University, Department of Physiotherapy, Biologihuset, Umeå, 90187, Sweden, 46 0907869835, sarah.marklund@umu.se %K COPD %K qualitative content analysis %K eHealth %K self-management %K primary care %K chronic disease %D 2021 %7 30.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Self-management strategies are regarded as highly prioritized in chronic obstructive pulmonary disease (COPD) treatment guidelines. However, individual and structural barriers lead to a staggering amount of people with COPD that are not offered support for such strategies, and new approaches are urgently needed to circumvent these barriers. A promising way of delivering health services such as support for self-management strategies is the use of eHealth tools. However, there is a lack of knowledge about the usage of, and factors affecting the use of, eHealth tools over time in people with COPD. Objective: This study aimed, among people with COPD, to explore and describe the experiences of an eHealth tool over time and factors that might affect usage. Methods: The eHealth tool included information on evidence-based self-management treatment for people with COPD, including texts, pictures, videos as well as interactive components such as a step registration function with automatized feedback. In addition to the latter, automated notifications of new content and pedometers were used as triggers to increase usage. After having access to the tool for 3 months, 16 individuals (12 women) with COPD were individually interviewed. At 12 months’ access to the tool, 7 (5 women) of the previous 16 individuals accepted a second individual interview. Data were analyzed using qualitative content analysis. User frequency was considered in the analysis, and participants were divided into users and nonusers/seldom users depending on the number of logins and minutes of usage per month. Results: Three main categories, namely, ambiguous impact, basic conditions for usage, and approaching capability emerged from the analysis, which, together with their subcategories, reflect the participants’ experiences of using the eHealth tool. Nonusers/seldom users (median 1.5 logins and 1.78 minutes spent on the site per month) reported low motivation, a higher need for technical support, a negative view about the disease and self-management, and had problematic health literacy as measured by the Communicative and Critical Health Literacy Scale (median [range] 154 [5-2102]). Users (median 10 logins and 43 minutes per month) felt comfortable with information technology (IT) tools, had a positive view on triggers, and had sufficient health literacy (median [range] 5 [5-1400]). Benefits including behavior changes were mainly expressed after 12 months had passed and mainly among users. Conclusions: Findings of this study indicate that the level of motivation, comfortability with IT tools, and the level of health literacy seem to affect usage of an eHealth tool over time. Besides, regarding behavioral changes, gaining benefits from the eHealth tool seems reserved for the users and specifically after 12 months, thus suggesting that eHealth tools can be suitable media for supporting COPD-specific self-management skills, although not for everyone or at all times. These novel findings are of importance when designing new eHealth tools as well as when deciding on whether or not an eHealth tool might be appropriate to use if the goal is to support self-management among people with COPD. Trial Registration: ClinicalTrials.gov NCT02696187; https://clinicaltrials.gov/ct2/show/NCT02696187 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2017-016851 %M 33929327 %R 10.2196/25672 %U https://www.jmir.org/2021/4/e25672 %U https://doi.org/10.2196/25672 %U http://www.ncbi.nlm.nih.gov/pubmed/33929327 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e24316 %T A Peer-to-Peer Live-Streaming Intervention for Children During COVID-19 Homeschooling to Promote Physical Activity and Reduce Anxiety and Eye Strain: Cluster Randomized Controlled Trial %A Zheng,Yingfeng %A Wang,Wei %A Zhong,Yuxin %A Wu,Fengchun %A Zhu,Zhuoting %A Tham,Yih-Chung %A Lamoureux,Ecosse %A Xiao,Liang %A Zhu,Erta %A Liu,Haoning %A Jin,Ling %A Liang,Linyi %A Luo,Lixia %A He,Mingguang %A Morgan,Ian %A Congdon,Nathan %A Liu,Yizhi %+ State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, No 7 Jinsui Rd, Room 509, Zhujiang New Town, Guangzhou, 510060, China, 86 13922286455, yingfeng.zheng@qq.com %K homeschooling %K children %K anxiety, digital eye strain %K peer to peer %K live streaming %K digital health %K intervention %K health information %K physical activity %K COVID-19 %K online learning %K behavior %K app %K mobile phone %D 2021 %7 30.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The COVID-19 pandemic has led to worldwide school closures, with millions of children confined to online learning at home. As a result, children may be susceptible to anxiety and digital eye strain, highlighting a need for population interventions. Objective: The objective of our study was to investigate whether a digital behavior change intervention aimed at promoting physical activity could reduce children’s anxiety and digital eye strain while undergoing prolonged homeschooling during the COVID-19 pandemic. Methods: In this cluster randomized controlled trial, homeschooled grade 7 students at 12 middle schools in southern China were recruited through local schools and randomly assigned by the school to receive (1:1 allocation): (1) health education information promoting exercise and ocular relaxation, and access to a digital behavior change intervention, with live streaming and peer sharing of promoted activities (intervention), or (2) health education information only (control). The primary outcome was change in self-reported anxiety score. Secondary outcomes included change in self-reported eye strain and sleep quality. Results: On March 16, 2020, 1009 children were evaluated, and 954 (94.5%) eligible children of consenting families were included in the intention-to-treat analysis. Children in the intervention (n=485, 6 schools) and control (n=469, 6 schools) groups were aged 13.5 (SD 0.5) years, and 52.3% (n=499) were male. The assigned interventions were completed by 896 children (intervention: n=467, 96.3%; control: n=429, 91.5%). The 2-week change in square-root–transformed self-reported anxiety scores was greater in the intervention (–0.23, 95% CI –0.27 to –0.20) vs control group (0.12, 95% CI 0.09-0.16; unadjusted difference –0.36, 95% CI –0.63 to –0.08; P=.02). There was a significant reduction in square-root–transformed eye strain in the intervention group (–0.08, 95% CI –0.10 to 0.06) compared to controls (0.07, 95% CI 0.05-0.09; difference –0.15, 95% CI –0.26 to –0.03; P=.02). Change in sleep quality was similar between the two groups. Conclusions: This digital behavior change intervention reduced children’s anxiety and eye strain during COVID-19–associated online schooling. Trial Registration: ClinicalTrials.gov NCT04309097; http://clinicaltrials.gov/ct2/show/NCT04309097 %M 33882021 %R 10.2196/24316 %U https://www.jmir.org/2021/4/e24316 %U https://doi.org/10.2196/24316 %U http://www.ncbi.nlm.nih.gov/pubmed/33882021 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 4 %P e29161 %T Using an Information Package to Reduce Patients’ Risk of Renal Damage: Protocol for a Randomized Feasibility Trial %A Leitch,Sharon %A Smith,Alesha %A Zeng,Jiaxu %A Stokes,Tim %+ Department of General Practice and Rural Health, Otago Medical School – Dunedin Campus, University of Otago, 55 Hanover Street, Dunedin, 9016, New Zealand, 64 0212619996, sharon.leitch@otago.ac.nz %K triple whammy %K medication safety %K patient education %K general practice %K NSAID %K digital intervention %K primary care %K safety %K protocol %K feasibility %K randomized controlled trial %K risk %K kidney %K renal %K information %K acceptability %D 2021 %7 30.4.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are a common cause of renal damage, especially when taken together with angiotensin-converting enzyme inhibitors (ACE-i) or angiotensin II receptor blockers (ARBs) plus a diuretic — a combination known as the “triple whammy.” New Zealand patients are at high risk of the “triple whammy” because they can easily purchase NSAIDs without a prescription and in nonpharmacy retail settings (eg, the supermarket), there is no legal requirement to include patient information sheets with medication, and direct-to-consumer drug advertising is permitted. A patient information package has been developed for those at greatest risk of the “triple whammy,” consisting of a printable PDF and an interactive online learning activity. This information package aims to inform patients about their elevated risk of harm from NSAIDS and discourage use of NSAIDs. A randomized control trial was planned to assess the effect of the information package. Objective: This study aims to pilot the trial procedures for recruiting patients and providing patient information online and to assess the acceptability of the patient information package. Methods: A two-armed randomized feasibility trial will be undertaken in Northland, New Zealand. We will recruit 50 patients who are at least 18 years old from those who have signed up to receive email alerts through their general practice. Patients eligible for this study have been prescribed an ACE-i or ARB plus a diuretic in the past 3 months. They will be randomly allocated to 2 study arms. The intervention arm will receive access to an information package plus usual care; the control arm will receive usual care alone. Online surveys will be used to assess NSAID knowledge and NSAID use at baseline and after 2 weeks for both arms. The intervention arm will also evaluate the information package in an additional survey based on Normalization Process Theory (NPT) concepts. We will report the number and proportion of participants who are eligible and consent to participate in the trial. Response and drop-out rates will be reported for each trial arm. The numbers of patients who interact with the education package will be reported together with the patient evaluation of it. Results: Funding has been obtained from the Health Research Council of New Zealand (HRC 18-031). The University of Otago Human Research Ethics Committee (H21/016) has approved this trial. Consultation has been undertaken with The Ngai Tahu research consultation committee. The trial commenced on April 12, 2021. Conclusions: This feasibility trial will test the study processes prior to commencing a randomized controlled trial and will determine the acceptability of the patient information package. We anticipate this work will provide useful information for other researchers attempting similar work. International Registered Report Identifier (IRRID): PRR1-10.2196/29161 %M 33929338 %R 10.2196/29161 %U https://www.researchprotocols.org/2021/4/e29161 %U https://doi.org/10.2196/29161 %U http://www.ncbi.nlm.nih.gov/pubmed/33929338 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e26939 %T Exploring the Role of Persuasive Design in Unguided Internet-Delivered Cognitive Behavioral Therapy for Depression and Anxiety Among Adults: Systematic Review, Meta-analysis, and Meta-regression %A McCall,Hugh C %A Hadjistavropoulos,Heather D %A Sundström,Christopher Richard Francis %+ Department of Psychology, University of Regina, 3737 Wascana Pkwy, Regina, SK, S4S 0A2, Canada, 1 306 585 4111, hugh.c.mccall@gmail.com %K ICBT %K internet %K depression %K anxiety %K persuasive design %K eHealth %D 2021 %7 29.4.2021 %9 Review %J J Med Internet Res %G English %X Background: Internet-delivered cognitive behavioral therapy (ICBT) is an effective treatment that can overcome barriers to mental health care. Various research groups have suggested that unguided ICBT (ie, ICBT without therapist support) and other eHealth interventions can be designed to enhance user engagement and thus outcomes. The persuasive systems design framework captures most design recommendations for eHealth interventions, but there is little empirical evidence that persuasive design is related to clinical outcomes in unguided ICBT. Objective: This study aims to provide an updated meta-analysis of randomized controlled trials of unguided ICBT for depression and anxiety, describe the frequency with which various persuasive design principles are used in such interventions, and use meta-regression to explore whether a greater number of persuasive design elements predicts efficacy in unguided ICBT for depression and anxiety. Methods: We conducted a systematic review of 5 databases to identify randomized controlled trials of unguided ICBT for depression and anxiety. We conducted separate random effects meta-analyses and separate meta-regressions for depression and anxiety interventions. Each meta-regression included 2 steps. The first step included, as a predictor, whether each intervention was transdiagnostic. For the meta-regression of ICBT for depression, the first step also included the type of control condition. The number of persuasive design principles identified for each intervention was added as a predictor in the second step to reveal the additional variance in effect sizes explained by persuasive design. Results: Of the 4471 articles we identified in our search, 46 (1.03%) were eligible for inclusion in our analyses. Our meta-analyses showed effect sizes (Hedges g) ranging from 0.22 to 0.31 for depression interventions, depending on the measures taken to account for bias in the results. We found a mean effect size of 0.45 (95% CI 0.33-0.56) for anxiety interventions, with no evidence that the results were inflated by bias. Included interventions were identified as using between 1 and 13 persuasive design principles, with an average of 4.95 (SD 2.85). The meta-regressions showed that a greater number of persuasive design principles predicted greater efficacy in ICBT for depression (R2 change=0.27; B=0.04; P=.02) but not anxiety (R2 change=0.05; B=0.03; P=.17). Conclusions: These findings show wide variability in the use of persuasive design in unguided ICBT for depression and anxiety and provide preliminary support for the proposition that more persuasively designed interventions are more efficacious, at least in the treatment of depression. Further research is needed to clarify the role of persuasive design in ICBT. %M 33913811 %R 10.2196/26939 %U https://www.jmir.org/2021/4/e26939 %U https://doi.org/10.2196/26939 %U http://www.ncbi.nlm.nih.gov/pubmed/33913811 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 4 %P e27826 %T Development of a Novel Intervention (Mindful Steps) to Promote Long-Term Walking Behavior in Chronic Cardiopulmonary Disease: Protocol for a Randomized Controlled Trial %A Litrownik,Daniel %A Gilliam,Elizabeth A %A Wayne,Peter M %A Richardson,Caroline R %A Kadri,Reema %A Rist,Pamela M %A Moy,Marilyn L %A Yeh,Gloria Y %+ Division of General Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Boston, MA, United States, 1 617 754 1423, DLITROW@gmail.com %K mind–body exercise %K internet-mediated intervention %K behavior change %K physical activity %K COPD %K heart failure %D 2021 %7 29.4.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite current rehabilitation programs, long-term engagement in physical activity remains a significant challenge for patients with chronic obstructive pulmonary disease (COPD) and heart failure (HF). Novel strategies to promote physical activity in these populations are greatly needed. Emerging literature on the benefits of both mind–body interventions and web-based interventions provide the rationale for the development of the Mindful Steps intervention for increasing walking behavior. Objective: This study aims to develop a novel multimodal mind–body exercise intervention through adaptation of an existing web-based physical activity intervention and incorporation of mind–body exercise, and to pilot test the delivery of the new intervention, Mindful Steps, in a randomized controlled feasibility trial in older adults with COPD and/or HF. Methods: In phase 1, guided by a theoretical conceptual model and review of the literature on facilitators and barriers of physical activity in COPD and HF, we convened an expert panel of researchers, mind–body practitioners, and clinicians to inform development of the novel, multimodal intervention. In phase 2, we are conducting a pilot randomized controlled feasibility trial of the Mindful Steps intervention that includes in-person mind–body exercise classes, an educational website, online mind–body videos, and a pedometer with step-count feedback and goals to increase walking behavior in patients with COPD and/or HF. Outcomes include feasibility measures as well as patient-centered measures. Results: The study is currently ongoing. Phase 1 intervention development was completed in March 2019, and phase 2 data collection began in April 2019. Conclusions: Through the integration of components from a web-based physical activity intervention and mind–body exercise, we created a novel, multimodal program to impact long-term physical activity engagement for individuals with COPD and HF. This developmental work and pilot study will provide valuable information needed to design a future clinical trial assessing efficacy of this multimodal approach. Trial Registration: ClinicalTrials.gov NCT03003780; https://clinicaltrials.gov/ct2/show/NCT03003780 International Registered Report Identifier (IRRID): DERR1-10.2196/27826 %M 33913819 %R 10.2196/27826 %U https://www.researchprotocols.org/2021/4/e27826 %U https://doi.org/10.2196/27826 %U http://www.ncbi.nlm.nih.gov/pubmed/33913819 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e24861 %T A Web-Based and In-Person Risk Reframing Intervention to Influence Mothers’ Tolerance for, and Parenting Practices Associated With, Children’s Outdoor Risky Play: Randomized Controlled Trial %A Brussoni,Mariana %A Han,Christina S %A Lin,Yingyi %A Jacob,John %A Pike,Ian %A Bundy,Anita %A Faulkner,Guy %A Gardy,Jennifer %A Fisher,Brian %A Mâsse,Louise %+ Department of Pediatrics, Faculty of Medicine, University of British Columbia, F508 – 4480 Oak Street, Vancouver, BC, V6H 3V4, Canada, 1 6048753712, mbrussoni@bcchr.ubc.ca %K outdoor play %K mothering %K independent mobility %K physical activity %K risk perception %K risky play %K risk reframing %D 2021 %7 27.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Outdoor risky play, such as climbing, racing, and independent exploration, is an important part of childhood and is associated with various positive physical, mental, and developmental outcomes for children. Parental attitudes and fears, particularly mothers’, are a major deterrent to children’s opportunities for outdoor risky play. Objective: The aim of this study was to evaluate the efficacy of 2 versions of an intervention to reframe mothers’ perceptions of risk and change parenting behaviors: a web-based intervention or an in-person workshop, compared with the control condition. Methods: The Go Play Outside! randomized controlled trial was conducted in Canada from 2017 to 2018. Participants were recruited through social media, snowball sampling, and community notices. Mothers of children aged 6-12 years were self-assessed through eligibility questions, and those eligible and consented to participate in the study were randomized into a fully automated web-based intervention, the in-person workshop, or the control condition. The intervention was underpinned by social cognitive theory, incorporating behavior change techniques. Participants progressed through a series of self-reflection exercises and developed a goal for change. Control participants received the Position Statement on Active Outdoor Play. The primary outcome was increase in tolerance of risky play and the secondary outcome was goal attainment. Data were collected online via REDCap at baseline, 1 week, and 3 months after the intervention. Randomization was conducted using sealed envelope. Allocations were concealed to researchers at assignment and data analysis. We conducted mediation analyses to examine whether the intervention influenced elements of social cognitive theory, as hypothesized. Results: A total of 451 mothers were randomized and completed baseline sociodemographic assessments: 150 in the web-based intervention, 153 in the in-person workshop, and 148 in the control condition. Among these, a total of 351 mothers completed the intervention. At 1 week after the intervention, 113, 85, and 135 mothers completed assessments for each condition, respectively, and at 3 months after the intervention, 105, 84, and 123 completed the assessments, respectively. Compared with mothers in the control condition, mothers in the web-based intervention had significantly higher tolerance of risky play at 1 week (P=.004) and 3 months after the intervention (P=.007); and mothers in the in-person workshop had significantly higher tolerance of risky play at 1 week after the intervention (P=.02). No other significant outcomes were found. None of the potential mediators were found to significantly mediate the outcomes. Conclusions: The trial demonstrates that the web-based intervention was effective in increasing mothers’ tolerance for risk in play. Trial Registration: ClinicalTrials.gov NCT03374683; https://clinicaltrials.gov/ct2/show/NCT03374683 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-018-2552-4 %M 33904820 %R 10.2196/24861 %U https://www.jmir.org/2021/4/e24861 %U https://doi.org/10.2196/24861 %U http://www.ncbi.nlm.nih.gov/pubmed/33904820 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e25333 %T An Internet-Based Intervention for Cardiovascular Disease Management Integrated With Primary Care Electronic Health Records: Mixed Methods Evaluation of Implementation Fidelity and User Engagement %A Coorey,Genevieve %A Peiris,David %A Scaria,Anish %A Mulley,John %A Neubeck,Lis %A Hafiz,Nashid %A Redfern,Julie %+ The George Institute for Global Health, Sydney, Australia, 1 King St, Newtown, Sydney, 2042, Australia, 61 80524644, gcoorey@georgeinstitute.org.au %K eHealth %K electronic health record %K web-based intervention %K implementation fidelity %K user engagement %K mixed methods %K cardiovascular disease %K primary health care %K mobile phone %D 2021 %7 26.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Growing evidence supports the benefits of eHealth interventions to increase patient engagement and improve outcomes for a range of conditions. However, ineffective program delivery and usage attrition limit exposure to these interventions and may reduce their effectiveness. Objective: This study aims to evaluate the delivery fidelity of an eHealth intervention, describe use patterns, compare outcomes between low and high users, and identify mediating factors on intervention delivery and receipt. Methods: This is a mixed methods study of an internet-based intervention being evaluated for effectiveness in a randomized controlled trial (RCT). The intervention comprised medication and cardiovascular disease (CVD) risk data uploaded from the primary care electronic health record (EHR); interactive, personalized CVD risk score estimation; goal setting and self-monitoring; an interactive social forum; and optional receipt of heart health messages. Fidelity was assessed over 12 months. Trial outcomes were compared between low and high users. Data sources included program delivery records, web log data, trial data, and thematic analysis of communication records. Results: Most participants in the intervention group (451/486, 93%) had an initial training session conducted by telephone (413/447, 92.4% of participants trained), with a mean duration of 44 minutes (range 10-90 minutes). Staff conducted 98.45% (1776/1804) of the expected follow-ups, mostly by telephone or email. Of the 451 participants who commenced log-ins, 46.8% (211) were categorized as low users (defined as at least one log-in in 3 or fewer months of follow-up), 40.4% (182) were categorized as high users (at least one log-in in more than 3 months of follow-up), and 12.8% (58) were nonadopters (no log-ins after their training session). The mean log-in frequency was 3-4 per month in ongoing users. There was no significant difference between the groups in the primary trial outcome of adherence to guideline-recommended medications (P=.44). In unadjusted analyses, high users had significantly greater eHealth literacy scores (P=.003) and were more likely to meet recommended weekly targets for fruit (P=.03) and fish (P=.004) servings; however, the adjusted findings were not significant. Interactive screen use was highest for goal tracking and lowest for the chat forum. Screens with EHR-derived data held only an early interest for most users. Fidelity measures (reach, content, dose delivered, and dose received) were influenced by the facilitation strategies used by staff, invisible qualities of staff-participant communication, and participants’ responsiveness to intervention attributes. Conclusions: A multifeature internet-based intervention was delivered with high fidelity to the RCT protocol and was regularly used by 40.4% (182/451) of users over 12 months. Higher log-in frequency as an indicator of greater intervention exposure was not associated with statistically significant improvements in eHealth literacy scores, lifestyle changes, or clinical outcomes. Attributes of the intervention and individualized support influenced initial and ongoing use. %M 33900204 %R 10.2196/25333 %U https://www.jmir.org/2021/4/e25333 %U https://doi.org/10.2196/25333 %U http://www.ncbi.nlm.nih.gov/pubmed/33900204 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 4 %P e22670 %T A Web-Based Lifestyle Intervention Aimed at Improving Cognition in Patients With Cancer Returning to Work in an Outpatient Setting: Protocol for a Randomized Controlled Trial %A Drijver,A Josephine %A Reijneveld,Jaap C %A Wesselman,Linda M P %A Klein,Martin %+ Department of Neurology, Amsterdam UMC, ZH 2 A 63, De Boelelaan 1117, Amsterdam, 1081 HV, Netherlands, 31 20444 4219, a.drijver@amsterdamumc.nl %K cancer %K cognitive functioning %K lifestyle %K web-based intervention %K RCT %K cancer-related cognitive impairment %D 2021 %7 26.4.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: A high percentage of patients with cancer experience cognitive impairment after cancer treatment, resulting in a decreased health-related quality of life and difficulty returning to work. Consequently, there is a need for effective treatment options to improve cognitive functioning in these patients. In a healthy aging population, multidomain web-based lifestyle interventions have been found to be effective in preventing cognitive decline and improving cognitive functioning. Objective: This study aims to investigate the feasibility and effectiveness of the web-based lifestyle intervention Mijn Fitte Brein (My Fit Brain [MFB]) on cognitive functioning in patients with cancer returning to work. Methods: The study consists of a feasibility study (N=10), followed by a randomized controlled trial (RCT; N=220). Patients will be recruited by their occupational physicians after their return to work following cancer treatment. Mijn Fitte Brein is organized into 4-week cycles in which patients set a lifestyle goal using the Goal Attainment Scale, receive weekly tips and support, and finally evaluate whether they succeeded in achieving this goal. Lifestyle goals are based on 6 domains: physical exercise, diet, sleep, stress, alcohol use, and smoking. In the feasibility study, data on user experience (structured interview) and usability, assessed with the Post-Study System Usability Scale, will be collected and used to optimize Mijn Fitte Brein. In the RCT, patients will be randomized 1:1 between an intervention group and a control group. Patients will be assessed at baseline, 3 months, and 6 months. The primary outcome measure is subjective cognitive functioning, assessed with the Functional Assessment of Cancer Therapy–Cognitive Function (FACT-Cog). Secondary outcome measures are lifestyle, objective cognitive functioning, and work and psychosocial factors. Results: Recruitment for the feasibility study has started in February 2020. As of July 2020, however, no patients have been enrolled (due to COVID-19 restrictions). The findings of the feasibility study will be used to optimize the Mijn Fitte Brein intervention. Enrollment for the RCT will continue when possible. The feasibility study will take 6 months (including making adjustments to the intervention), and the RCT will take 2 years. The final results are expected in 2024. The results of the feasibility study and the RCT will be published in peer-reviewed journals. Conclusions: This is the first time the feasibility and efficacy of a multidomain web-based lifestyle intervention will be studied in patients with cancer. If Mijn Fitte Brein is found to be effective in decreasing cognitive complaints in these patients returning to work, it will be a promising treatment option because of being both affordable and accessible. Trial Registration: Netherlands Trial Register NL8407; https://www.trialregister.nl/trial/8407 International Registered Report Identifier (IRRID): DERR1-10.2196/22670 %M 33900201 %R 10.2196/22670 %U https://www.researchprotocols.org/2021/4/e22670 %U https://doi.org/10.2196/22670 %U http://www.ncbi.nlm.nih.gov/pubmed/33900201 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e25480 %T Feasibility of a Web-Based Psychoeducation Course and Experiences of Caregivers Living With a Person With Schizophrenia Spectrum Disorder: Mixed Methods Study %A Laine,Anna %A Anttila,Minna %A Hirvonen,Heli %A Välimäki,Maritta %+ Department of Nursing Science, University of Turku, 20014 University of Turku, Turku, , Finland, 358 406890546, mava@utu.fi %K caregiver %K informal caregiver %K internet %K mental health %K psychoeducation %K schizophrenia %K mobile phone %D 2021 %7 23.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Schizophrenia is a severe mental illness that burdens both patients and caregivers. Objective: The aim of this study is to examine the feasibility of a web-based psychoeducation course targeted at caregivers of persons with schizophrenia spectrum disorders (SSDs) and to describe their experiences of living with a person with SSD based on the material caregivers produced during the web-based course. Methods: A convergent, parallel, mixed methods study design was used. First, caregivers’ engagement in the course was evaluated quantitatively. Second, the overview of the course feedback was evaluated using quantitative and qualitative methods. Third, the experiences of being a caregiver to a person with SSD were analyzed qualitatively with the thematic analysis of the writings caregivers produced during the web-based course. Results: A total of 30 caregivers participated in the study and a web-based psychoeducation course. Less than two-thirds (18/30, 60%) completed the course. Content was most often logged for the first module, Orientation (3465 log-ins), and the lowest number of log-ins was recorded for the Daily life module (1061 log-ins). Feedback on the course varied; over half (10/17, 59%) of the caregivers considered the content to be very good or good, about half (9/17, 53%) considered the website layout to be good, only 6% (1/17) felt that the usability of the website was poor, and no one felt that it was very poor. From the reported experiences of being a caregiver to a person with SSD, 3 themes were formed: the caregiver’s own well-being, relationship with the person with SSD, and experience of health care services. Conclusions: The web-based psychoeducation course for caregivers living with a person with SSD seems to be especially suitable for those who have little experience as a caregiver. In the future, more planning and the consideration of aspects related to the needs of specific target groups, course content, practical arrangements, and scheduling should be taken into account. In addition, although caregivers can improve their own well-being in different ways, they need regular support and cooperation from health care professionals. %M 33890862 %R 10.2196/25480 %U https://www.jmir.org/2021/4/e25480 %U https://doi.org/10.2196/25480 %U http://www.ncbi.nlm.nih.gov/pubmed/33890862 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e23487 %T A Direct-to-Public Peer Support Program (Big White Wall) Versus Web-Based Information to Aid the Self-management of Depression and Anxiety: Results and Challenges of an Automated Randomized Controlled Trial %A Morriss,Richard %A Kaylor-Hughes,Catherine %A Rawsthorne,Matthew %A Coulson,Neil %A Simpson,Sandra %A Guo,Boliang %A James,Marilyn %A Lathe,James %A Moran,Paul %A Tata,Laila J %A Williams,Laura %+ Institute of Mental Health, University of Nottingham, Jubilee Campus, Triumph Road, Nottingham, NG7 2TU, United Kingdom, 44 1158230427, richard.morriss@nottingham.ac.uk %K peer support %K digital mental health %K depression %K anxiety %K population reach %K productivity %K mobile phone %D 2021 %7 23.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Effective help for depression and anxiety reaches a small proportion of people who might benefit from it. The scale of the problem suggests the need for effective, safe web-based public health services delivered directly to the public. One model, the Big White Wall (BWW), offers peer support at low cost. As these interventions are delivered digitally, we tested whether a randomized controlled trial (RCT) intervention could also be fully delivered and evaluated digitally. Objective: This study aims to determine the reach, feasibility, acceptability, baseline costs, and outcomes of a public health campaign for an automated RCT of the BWW, providing digital peer support and information, compared with a standard website used by the National Health Service Moodzone (MZ), to people with probable mild-to-moderate depression and anxiety disorder. The primary outcome was the change in self-rated well-being at 6 weeks, measured using the Warwick-Edinburgh Mental Well-Being Scale. Methods: An 18-month campaign was conducted across Nottinghamshire, the United Kingdom (target population 914,000) to advertise the trial directly to the public through general marketing, web-based and social media sources, health services, other public services, and third-sector groups. The population reach of this campaign was examined by the number of people accessing the study website and self-registering to the study. A pragmatic, parallel-group, single-blind RCT was then conducted using a fully automated trial website in which eligible participants were randomized to receive either 6 months of access to BWW or signposted to MZ. Those eligible for participation were aged >16 years with probable mild-to-moderate depression or anxiety disorders. Results: Of 6483 visitors to the study website, 1510 (23.29%) were eligible. Overall, 790 of 1510 (52.32%) visitors participated. Of 790 visitors, 397 (50.3%) were randomized to BWW and 393 (49.7%) to MZ. Their mean age was 38 (SD 13.8) years, 81.0% (640/790) were female, 93.4% (738/790) were White, and 47.4% (271/572) had no contact with health services in the previous 3 months. We estimated 3-month productivity losses of £1001.01 (95% CI 868.75-1133.27; US $1380.79; 95% CI 1198.35-1563.23) per person for those employed. Only 16.6% (131/790) participants completed the primary outcome assessment. There were no differences in the primary or secondary outcomes between the 2 groups. Conclusions: Most participants reached and those eligible for this trial of digital interventions were White women not in recent contact with health services and whose productivity losses represent a significant annual societal burden. A fully automated RCT recruiting directly from the public failed to recruit and retain sufficient participants to test the clinical effectiveness of this digital intervention, primarily because it did not personally engage participants and explain how these unfamiliar interventions might benefit them. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 12673428; https://www.isrctn.com/ISRCTN12673428 International Registered Report Identifier (IRRID): RR2-10.2196/resprot.8061 %M 33890858 %R 10.2196/23487 %U https://www.jmir.org/2021/4/e23487 %U https://doi.org/10.2196/23487 %U http://www.ncbi.nlm.nih.gov/pubmed/33890858 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e22477 %T eHealth Interventions to Address Sexual Health, Substance Use, and Mental Health Among Men Who Have Sex With Men: Systematic Review and Synthesis of Process Evaluations %A Meiksin,Rebecca %A Melendez-Torres,G J %A Falconer,Jane %A Witzel,T Charles %A Weatherburn,Peter %A Bonell,Chris %+ London School of Hygiene & Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, United Kingdom, 44 (0)20 7927 2893, rebecca.meiksin@lshtm.ac.uk %K eHealth %K digital health %K men who have sex with men %K sexual health %K HIV %K STI %K substance use %K mental health %K systematic review %K process evaluation %D 2021 %7 23.4.2021 %9 Review %J J Med Internet Res %G English %X Background: Men who have sex with men (MSM) face disproportionate risks concerning HIV and other sexually transmitted infections, substance use, and mental health. These outcomes constitute an interacting syndemic among MSM; interventions addressing all 3 together could have multiplicative effects. eHealth interventions can be accessed privately, and evidence from general populations suggests these can effectively address all 3 health outcomes. However, it is unclear how useable, accessible, or acceptable eHealth interventions are for MSM and what factors affect this. Objective: We undertook a systematic review of eHealth interventions addressing sexual risk, substance use, and common mental illnesses among MSM and synthesized evidence from process evaluations. Methods: We searched 19 databases, 3 trials registers, OpenGrey, and Google, and supplemented this by reference checks and requests to experts. Eligible reports were those that discussed eHealth interventions offering ongoing support to MSM aiming to prevent sexual risk, substance use, anxiety or depression; and assessed how intervention delivery or receipt varied with characteristics of interventions, providers, participants, or context. Reviewers screened citations on titles, abstracts, and then full text. Reviewers assessed quality of eligible studies, and extracted data on intervention, study characteristics, and process evaluation findings. The analysis used thematic synthesis. Results: A total of 12 reports, addressing 10 studies of 8 interventions, were eligible for process synthesis. Most addressed sexual risk alone or with other outcomes. Studies were assessed as medium and high reliability (reflecting the trustworthiness of overall findings) but tended to lack depth and breadth in terms of the process issues explored. Intervention acceptability was enhanced by ease of use; privacy protection; use of diverse media; opportunities for self-reflection and to gain knowledge and skills; and content that was clear, interactive, tailored, reflective of MSM’s experiences, and affirming of sexual-minority identity. Technical issues and interventions that were too long detracted from acceptability. Some evidence suggested that acceptability varied by race or ethnicity and educational level; findings on variation by socioeconomic status were mixed. No studies explored how intervention delivery or receipt varied by provider characteristics. Conclusions: Findings suggest that eHealth interventions targeting sexual risk, substance use, and mental health are acceptable for MSM across sociodemographic groups. We identified the factors shaping MSM’s receipt of such interventions, highlighting the importance of tailored content reflecting MSM’s experiences and of language affirming sexual-minority identities. Intervention developers can draw on these findings to increase the usability and acceptability of integrated eHealth interventions to address the syndemic of sexual risk, substance use, and mental ill health among MSM. Evaluators of these interventions can draw on our findings to plan evaluations that explore the factors shaping usability and acceptability. %M 33890855 %R 10.2196/22477 %U https://www.jmir.org/2021/4/e22477 %U https://doi.org/10.2196/22477 %U http://www.ncbi.nlm.nih.gov/pubmed/33890855 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e19187 %T Web-Based Smartphone Algorithm for Calculating Blood Pressure From Photoplethysmography Remotely in a General Adult Population: Validation Study %A Holyoke,Paul %A Yogaratnam,Karthika %A Kalles,Elizabeth %+ SE Research Centre, SE Health, 90 Allstate Parkway, Markham, ON, L3R 6H3, Canada, 1 4168923791, paulholyoke@sehc.com %K blood pressure measurement %K remote monitoring %K hypertension %D 2021 %7 23.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Outside of a clinical setting, oscillometric devices make remote monitoring of blood pressure and virtual care more convenient and feasible. HeartBeat Technologies Ltd developed a novel approach to measuring blood pressure remotely after an initial blood pressure reading by a nurse using the conventional measurement method. Using a finger pulse oximeter, a photoplethysmogram wave is transmitted by Bluetooth to a smartphone or tablet. A smartphone app (MediBeat) transmits the photoplethysmogram to a server for analysis by a proprietary algorithm—the person’s current blood pressure is sent back to the smartphone and to the individual’s health care provider. Objective: This study sought to determine whether the HeartBeat algorithm calculates blood pressure as accurately as required by the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) for validation of blood pressure measuring devices. Methods: ESH-IP2 requirements, modified to conform to a more recent international consensus statement, were followed. The ESH-IP2 establishes strict guidelines for the conduct and reporting of any validation of any device to measure blood pressure, including using the standard manual blood pressure instrument as a comparator and specific required accuracy levels for low, medium, and high ranges of blood pressure readings. The consensus statement requires a greater number of study participants for each of the blood pressure ranges. The validation of the accuracy of the algorithm was conducted with a Contec CMS50EW pulse oximeter and a Samsung Galaxy XCover 4 smartphone. Results: The differences between the HeartBeat-calculated and the manually measured blood pressures of 62 study participants did not meet the ESH-IP2 standards for accuracy for either systolic or diastolic blood pressure measurements. There was no discernible pattern in the inaccuracies of the HeartBeat-calculated measurements. Conclusions: The October 4, 2019 version of the HeartBeat algorithm, implemented in combination with the MediBeat app, a pulse oximeter, and an Android smartphone, was not sufficiently accurate for use in a general adult population. Trial Registration: ClinicalTrials.gov NCT04082819; http://clinicaltrials.gov/ct2/show/NCT04082819 %M 33890856 %R 10.2196/19187 %U https://www.jmir.org/2021/4/e19187 %U https://doi.org/10.2196/19187 %U http://www.ncbi.nlm.nih.gov/pubmed/33890856 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 4 %P e24605 %T Implementing a Peer Advocate Mental Health Digital Intervention Program for Ohio Youth: Descriptive Pilot Study %A Albritton,Tashuna %A Ford,Kelsey Lynett %A Elsbernd,Kira %A Santodomingo,Melodie %A Juzang,Ivan %A Weddington,Pam %A Bull,Sheana %+ CUNY School of Medicine, City College of New York, 160 Convent Ave, New York, NY, 10031, United States, 1 212 650 8224, talbritton@med.cuny.edu %K mental health %K adolescent %K digital health %K suicide prevention %K social support %K youth %D 2021 %7 23.4.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: In the United States, millions of adolescents report poor mental health, where 1 in 5 teenagers considers suicide. Reducing stigma and fostering peer support remains critical for positive mental health interventions and programs. Increasingly, digital mental health tools have emerged with great promise, leveraging social networks. Despite the potential, limited understanding of such comprehensive programs and their implementation exist. Objective: The objective of this study investigates a piloted digital mental health training program (Be Present) for youth, specifically describing the impact on youth behavioral outcomes and user engagement and identifying high-risk youth in the early phases of prevention. Methods: Eligibility included Ohio residents (aged 14 to 22 years) to be enrolled as either a Friend or a Peer Advocate. From May 1 to June 1, 2019, participants completed the Advocate training course, taking pretest and posttest surveys. Single-arm descriptive analyses measured youth outcomes (self-efficacy, intentions, behaviors, social support, knowledge, and sources of strength) and engagement and assessed risk based on survey responses. Results: A total of 65 adolescents participated, with 54 completing both pretest and posttest surveys. The majority of participants included non-Hispanic White females. Findings illustrated a significant increase in self-report of referrals for mental health services as well as in perceptions that youth had of experiencing social support; however, no significant differences were found for measures of self-efficacy, knowledge, and sources of strength between pretest and posttest surveys. Roughly two-thirds of the participants completed all of the Advocate training modules, and we observed a gradual decline in engagement. Most respondents who received escalated high-risk response messages identified as female. Conclusions: The pilot presented promise for implementing a digital mental health program focused on peer support, specifically observing reported youth behavioral outcomes and user engagement and identifying high-risk youth. Various limitations exist given the small nonrepresentative sample and lack of control group. All findings should be considered preliminary to a larger trial and underscore the feasibility of delivering online training programs to bolster adolescent mental health. Such formative evaluation proved critical for future implementation and research, offering opportunity for substantial improvements for real-world digital mental health programs. %M 33890868 %R 10.2196/24605 %U https://mental.jmir.org/2021/4/e24605 %U https://doi.org/10.2196/24605 %U http://www.ncbi.nlm.nih.gov/pubmed/33890868 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 4 %P e26268 %T Digital Health Interventions in Prevention, Relapse, and Therapy of Mild and Moderate Depression: Scoping Review %A Tokgöz,Pinar %A Hrynyschyn,Robert %A Hafner,Jessica %A Schönfeld,Simone %A Dockweiler,Christoph %+ School of Public Health, Bielefeld University, Universitätsstraße 25, Bielefeld, 33615, Germany, 49 521 106 67136, pinar.tokgoez@uni-bielefeld.de %K digital health %K depression %K scoping review %K health care %D 2021 %7 16.4.2021 %9 Review %J JMIR Ment Health %G English %X Background: Depression is a major cause for disability worldwide, and digital health interventions are expected to be an augmentative and effective treatment. According to the fast-growing field of information and communication technologies and its dissemination, there is a need for mapping the technological landscape and its benefits for users. Objective: The purpose of this scoping review was to give an overview of the digital health interventions used for depression. The main goal of this review was to provide a comprehensive review of the system landscape and its technological state and functions, as well as its evidence and benefits for users. Methods: A scoping review was conducted to provide a comprehensive overview of the field of digital health interventions for the treatment of depression. PubMed, PSYNDEX, and the Cochrane Library were searched by two independent researchers in October 2020 to identify relevant publications of the last 10 years, which were examined using the inclusion and exclusion criteria. To conduct the review, we used Rayyan, a freely available web tool. Results: In total, 65 studies were included in the qualitative synthesis. After categorizing the studies into the areas of prevention, early detection, therapy, and relapse prevention, we found dominant numbers of studies in the area of therapy (n=52). There was only one study for prevention, 5 studies for early detection, and 7 studies for relapse prevention. The most dominant therapy approaches were cognitive behavioral therapy, acceptance and commitment therapy, and problem-solving therapy. Most of the studies revealed significant effects of digital health interventions when cognitive behavioral therapy was applied. Cognitive behavioral therapy as the most dominant form was often provided through web-based systems. Combined interventions consisting of web-based and smartphone-based approaches are increasingly found. Conclusions: Digital health interventions for treating depression are quite comprehensive. There are different interventions focusing on different fields of care. While most interventions can be beneficial to achieve a better depression treatment, it can be difficult to determine which approaches are suitable. Cognitive behavioral therapy through digital health interventions has shown good effects in the treatment of depression, but treatment for depression still stays very individualistic. %M 33861201 %R 10.2196/26268 %U https://mental.jmir.org/2021/4/e26268 %U https://doi.org/10.2196/26268 %U http://www.ncbi.nlm.nih.gov/pubmed/33861201 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 4 %P e24647 %T A Gamified, Social Media–Inspired, Web-Based Personalized Normative Feedback Alcohol Intervention for Lesbian, Bisexual, and Queer-Identified Women: Protocol for a Hybrid Trial %A Boyle,Sarah C %A LaBrie,Joseph W %+ HeadsUp Labs, Department of Psychology, Loyola Marymount University, 1 LMU Drive, Suite 3787, Los Angeles, CA, 90045, United States, 1 8182909940, sarah.boyle@lmu.edu %K sexual minority women %K alcohol %K intervention %K social norms %K gamification %K protocol %K mobile phone %D 2021 %7 16.4.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Sexual minority women are more likely to drink alcohol, engage in heavy drinking, and experience alcohol-related problems than heterosexual women. However, culturally tailored interventions for this population have been slow to emerge. Objective: This type 1 effectiveness-implementation trial examines the feasibility and efficacy of a gamified, culturally tailored, personalized normative feedback (PNF) alcohol intervention for sexual minority women who psychologically identify as lesbian, bisexual, or queer (LBQ). Methods: The core components of a PNF intervention were delivered within LezParlay, a fun, social media–inspired, digital competition designed to challenge negative stereotypes about LBQ women and increase visibility. The competition was advertised on the web through social media platforms and collaboration with LBQ community organizations. After 2 rounds of play by a large cohort of LBQ women, a subsample of 500 drinkers already taking part in the competition were invited to participate in the evaluation study. Study participants were randomized to receive 1 of 3 unique sequences of PNF (ie, alcohol and stigma coping, alcohol and control, or control topics only) over 2 intervention rounds. Randomization was fully automated by the web app, and both researchers and participants were blinded. Results: Analyses will evaluate whether PNF on alcohol use reduces participants’ drinking and negative consequences at 2 and 4 months postintervention; examine whether providing PNF on stigma-coping behaviors, in addition to alcohol use, further reduces alcohol use and consequences beyond PNF on alcohol alone; identify mediators and moderators of intervention efficacy; and examine broader LezParlay app engagement, acceptability, and perceived benefits. Conclusions: This incognito intervention approach is uniquely oriented toward engaging and preventing alcohol-related risks among community populations of LBQ women who may view their heavy drinking as normative and not in need of change because of the visibility of alcohol use in sexual minority community spaces. Thus, this intervention strategy diverges from, and is intended to complement, more intensive programs being developed to meet the needs of LBQ women already motivated to reduce their consumption. Trial Registration: ClinicalTrials.gov NCT03884478; https://clinicaltrials.gov/ct2/show/NCT03884478 International Registered Report Identifier (IRRID): DERR1-10.2196/24647 %M 33861212 %R 10.2196/24647 %U https://www.researchprotocols.org/2021/4/e24647 %U https://doi.org/10.2196/24647 %U http://www.ncbi.nlm.nih.gov/pubmed/33861212 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e25358 %T Participant Perceptions of Facilitators and Barriers to Adherence in a Digital Mental Health Intervention for a Nonclinical Cohort: Content Analysis %A Renfrew,Melanie Elise %A Morton,Darren Peter %A Northcote,Maria %A Morton,Jason Kyle %A Hinze,Jason Scott %A Przybylko,Geraldine %+ Lifestyle Medicine and Health Research Centre, Avondale University College, 582 Freemans Drive, Cooranbong, NSW, 2265, Australia, 61 405445151, melanie.renfrew@avondale.edu.au %K web-based mental health %K health promotion %K eHealth %K adherence %K participant perceptions %K mobile phone %D 2021 %7 14.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital mental health promotion interventions (MHPIs) present a scalable opportunity to attenuate the risk of mental health distress among nonclinical cohorts. However, adherence is frequently suboptimal, and little is known about participants’ perspectives concerning facilitators and barriers to adherence in community-based settings. Objective: This study aimed to examine participants’ perceptions of facilitators and barriers to adherence in a web- and mobile app–based MHPI for a nonclinical cohort. Methods: This qualitative study used inductive, reflexive thematic analysis to explore free-text responses in a postintervention evaluation of a 10-week digital MHPI. The intervention was administered using a web and mobile app from September to December 2018. Participants (N=320) were Australian and New Zealand members of a faith-based organization who self-selected into the study, owned a mobile phone with messaging capability, had an email address and internet access, were fluent in English, provided informed consent, and gave permission for their data to be used for research. The postintervention questionnaire elicited participants’ perceptions of facilitators and barriers to adherence during the intervention period. Results: Key factors that facilitated adherence were engaging content, time availability and management, ease of accessibility, easy or enjoyable practical challenges, high perceived value, and personal motivation to complete the intervention. The primary perceived barrier to adherence was the participants’ lack of time. Other barriers included completing and recording practical activities, length of video content, technical difficulties, and a combination of personal factors. Conclusions: Time scarcity was the foremost issue for the nonclinical cohort engaged in this digital MHPI. Program developers should streamline digital interventions to minimize the time investment for participants. This may include condensed content, optimization of intuitive web and app design, simplified recording of activities, and greater participant autonomy in choosing optional features. Nonetheless, participants identified a multiplicity of other interindividual factors that facilitated or inhibited adherence. %M 33851925 %R 10.2196/25358 %U https://www.jmir.org/2021/4/e25358 %U https://doi.org/10.2196/25358 %U http://www.ncbi.nlm.nih.gov/pubmed/33851925 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 4 %P e24976 %T Feasibility and Acceptability of a Smoking Cessation Smartphone App (My QuitBuddy) in Older Persons: Pilot Randomized Controlled Trial %A Peek,Jenny %A Hay,Karen %A Hughes,Pauline %A Kostellar,Adrienne %A Kumar,Subodh %A Bhikoo,Zaheerodin %A Serginson,John %A Marshall,Henry M %+ The University of Queensland Thoracic Research Centre, The Prince Charles Hospital, Level 2, Admin Building, Rode Rd, Chermside, 4032, Australia, 61 (07) 3139 6802, jenny.peek@health.qld.gov.au %K mHealth %K mobile apps %K motivation %K smartphone %K smoking cessation %K tobacco smoking %D 2021 %7 14.4.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Although many smoking cessation smartphone apps exist, few have been independently evaluated, particularly in older populations. In 2017, of the 112 commercially available smoking cessation apps in Australia, only 6 were deemed to be of high quality, in that they partially adhered to Australian guidelines. Mobile health (mHealth) apps have the potential to modify smoking behavior at a relatively low cost; however, their acceptability in older smokers remains unknown. Rigorous scientific evaluation of apps is thus urgently needed to assist smokers and clinicians alike. Objective: We conducted a pilot randomized controlled trial to evaluate the feasibility of a large-scale trial to assess the use and acceptability of a high-quality smoking cessation app in older smokers. Methods: Adult inpatient and outpatient smokers with computer and smartphone access were recruited face to face and via telephone interviews from Metropolitan Hospitals in Brisbane, Australia. Participants were randomized 1:1 to the intervention (requested to download the “My QuitBuddy” smoking cessation app on their smartphone) or the control group (provided access to a tailored smoking cessation support webpage [Quit HQ]). The My QuitBuddy app is freely available from app stores and provides personalized evidenced-based smoking cessation support. Quit HQ offers regular email support over 12 weeks. No training or instructions on the use of these e-resources were given to participants. Outcomes at 3 months included recruitment and retention rates, use and acceptability of e-resource (User Version of the Mobile App Rating Scale [uMARS]), changes in quitting motivation (10-point scale), and self-reported smoking abstinence. Results: We randomized 64 of 231 potentially eligible individuals (27.7%). The mean age of participants was 62 (SD 8). Nicotine dependence was moderate (mean Heaviness of Smoking Index [HSI] 2.8 [SD 1.2]). At 3 months the retention rate was (58/64, 91%). A total of 15 of 31 participants in the intervention arm (48%) used the app at least once, compared with 10 of 33 (30%) in the control arm. uMARS scores for e-resource use and acceptability were statistically similar (P=.29). Motivation to quit was significantly higher in the intervention arm compared with the control arm (median 6 [IQR 4-8] versus 4 [IQR 4-5], respectively, P=.02). According to the intention-to-treat analysis, smoking abstinence was nonsignificantly higher in the intervention group (4/31 [13%], 95% CI 4%-30%, versus 2/33 [6%], 95% CI 1%-20%; P=.42). The estimated number needed to treat was 14. Conclusions: Internet and mHealth smoking cessation resources appear acceptable to a minority of older smokers. Smokers who engaged with the allocated e-resources rated them equally, and there were trends toward greater uptake, increased motivation, and higher abstinence rates in the app group; however, only the change in motivation reached statistical significance (median score 6 versus 4, respectively, P=.02). This results of this pilot study suggest that apps may improve quit outcomes in older adults who are willing to use them. Further research into user–app interactions should be undertaken to facilitate improvements in app design and consumer engagement. These favorable trends should be explored in larger trials with sufficient statistical power. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619000159156; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376849&isReview=true %M 33851923 %R 10.2196/24976 %U https://formative.jmir.org/2021/4/e24976 %U https://doi.org/10.2196/24976 %U http://www.ncbi.nlm.nih.gov/pubmed/33851923 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e25219 %T Predictors of Parental Barriers to Reduce Excessive Child Screen Time Among Parents of Under-Five Children in Selangor, Malaysia: Cross-sectional Study %A Mansor,Elliza %A Ahmad,Norliza %A Raj,Diana %A Mohd Zulkefli,Nor Afiah %A Mohd Shariff,Zalilah %+ Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, 43400, Malaysia, 60 019 271 0577, lizaahmad@upm.edu.my %K child %K self-efficacy %K screen time %K Malaysia %K parent-child relations %K public sector %K children %K screen %K parental %D 2021 %7 13.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Globally, there is an increasing prevalence of excessive screen time exposure among young children, including in Malaysia. Parents are advised to limit this exposure, but there are barriers for many of them to follow this recommendation. To date, there is a lack of research on the factors that cause these parental barriers. Objective: This study aimed to determine the parental barrier toward the reduction of excessive child screen time and its predictors among parents of children aged younger than 5 years in the Petaling District, Selangor, Malaysia. Methods: A cross-sectional study was conducted from April 2019 to June 2020 among 789 parent-child dyads attending child health clinics in the Petaling District. Validated self-administered questionnaires were used to capture information on sociodemographic, parental, child-related, and environmental factors and parental barriers. Stratified sampling with probability proportionate to size was employed. Data were analyzed using SPSS Statistics version 25 (IBM Corp). Descriptive analysis and bivariable analysis were performed before multiple linear regression was used to identify predictors of parental barriers. Results: The overall mean score of parental barriers was 3.51 (SD 0.83), indicating that the average numbers of barriers experienced by parents were more than 3. The multivariable analysis showed that the predictors of parental barriers included monthly household income (adjusted β=–.03, 95% CI –0.05 to –0.02), parents who worked in public sectors (adjusted β=.18, 95% CI 0.06 to 0.29), positive parental attitude on screens (adjusted β=.68, 95% CI 0.58 to 0.79), low parent self-efficacy to influence child’s physical activity (adjusted β=–.32, 95% CI –0.43 to –0.20), and child screen time (adjusted β=.04, 95% CI 0.02 to 0.06). Conclusions: The strongest predictor of parental barriers to reduce excessive child screen time was the positive parental attitude on screen time which could contribute to their abilities to limit child screen time. Thus, future intervention strategies should aim to foster correct parental attitudes toward screen time activities among young children. %M 33847590 %R 10.2196/25219 %U https://www.jmir.org/2021/4/e25219 %U https://doi.org/10.2196/25219 %U http://www.ncbi.nlm.nih.gov/pubmed/33847590 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 7 %N 2 %P e18819 %T A Home-Based Mobile Health Intervention to Replace Sedentary Time With Light Physical Activity in Older Cancer Survivors: Randomized Controlled Pilot Trial %A Blair,Cindy K %A Harding,Elizabeth %A Wiggins,Charles %A Kang,Huining %A Schwartz,Matthew %A Tarnower,Amy %A Du,Ruofei %A Kinney,Anita Y %+ Department of Internal Medicine, University of New Mexico, 1 University of New Mexico, MSC07-4025, Albuquerque, NM, United States, 1 5059257907, CiBlair@salud.unm.edu %K light-intensity physical activity %K physical activity %K sedentary behavior %K mobile health %K cancer survivors %K consumer wearable %K activity monitor %K mobile phone %D 2021 %7 13.4.2021 %9 Original Paper %J JMIR Cancer %G English %X Background: Older cancer survivors are at risk of the development or worsening of both age- and treatment-related morbidity. Sedentary behavior increases the risk of or exacerbates these chronic conditions. Light-intensity physical activity (LPA) is more common in older adults and is associated with better health and well-being. Thus, replacing sedentary time with LPA may provide a more successful strategy to reduce sedentary time and increase physical activity. Objective: This study primarily aims to evaluate the feasibility, acceptability, and preliminary efficacy of a home-based mobile health (mHealth) intervention to interrupt and replace sedentary time with LPA (standing and stepping). The secondary objective of this study is to examine changes in objective measures of physical activity, physical performance, and self-reported quality of life. Methods: Overall, 54 cancer survivors (aged 60-84 years) were randomized in a 1:1:1 allocation to the tech support intervention group, tech support plus health coaching intervention group, or waitlist control group. Intervention participants received a Jawbone UP2 activity monitor for use with their smartphone app for 13 weeks. Tech support and health coaching were provided via 5 telephone calls during the 13-week intervention. Sedentary behavior and physical activity were objectively measured using an activPAL monitor for 7 days before and after the intervention. Results: Participants included survivors of breast cancer (21/54, 39%), prostate cancer (16/54, 30%), and a variety of other cancer types; a mean of 4.4 years (SD 1.6) had passed since their cancer diagnosis. Participants, on average, were 70 years old (SD 4.8), 55% (30/54) female, 24% (13/54) Hispanic, and 81% (44/54) overweight or obese. Malfunction of the Jawbone trackers occurred in one-third of the intervention group, resulting in enrollment stopping at 54 rather than the initial goal of 60 participants. Despite these technical issues, the retention in the intervention was high (47/54, 87%). Adherence was high for wearing the tracker (29/29, 100%) and checking the app daily (28/29, 96%) but low for specific aspects related to the sedentary features of the tracker and app (21%-25%). The acceptability of the intervention was moderately high (81%). There were no significant between-group differences in total sedentary time, number of breaks, or number of prolonged sedentary bouts. There were no significant between-group differences in physical activity. The only significant within-group change occurred within the health coaching group, which increased by 1675 daily steps (95% CI 444-2906; P=.009). This increase was caused by moderate-intensity stepping rather than light-intensity stepping (+15.2 minutes per day; 95% CI 4.1-26.2; P=.008). Conclusions: A home-based mHealth program to disrupt and replace sedentary time with stepping was feasible among and acceptable to older cancer survivors. Future studies are needed to evaluate the optimal approach for replacing sedentary behavior with standing and/or physical activity in this population. Trial Registration: ClinicalTrials.gov NCT03632694; https://clinicaltrials.gov/ct2/show/NCT03632694 %M 33847588 %R 10.2196/18819 %U https://cancer.jmir.org/2021/2/e18819 %U https://doi.org/10.2196/18819 %U http://www.ncbi.nlm.nih.gov/pubmed/33847588 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e19743 %T Perceptions of and Opinions on a Computerized Behavioral Activation Program for the Treatment of Depression in Young People: Thematic Analysis %A Tindall,Lucy %A Toner,Paul %A Mikocka-Walus,Antonina %A Wright,Barry %+ Department of Health Sciences, University of York, Heslington, York, YO105DD, United Kingdom, 44 7976774636, lucy.tindall@york.ac.uk %K depression %K qualitative %K thematic analysis %K young people %K health care professionals %K computerized therapies %D 2021 %7 13.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression is one of the leading causes of illness and disability in young people, with approximately 20% having experienced a depressive episode by the age of 18 years. Behavioral activation (BA), a National Institute for Health and Care Excellence–recommended treatment for adults with depression, has shown preliminary support for its use with young people. BA may have the potential to be adapted and delivered in a computerized format to address the barriers often associated with young people accessing support. Despite the benefits of adopting computerized therapy delivery, the limited effectiveness of some programs has been attributed to a failure to tailor interventions to patients and practices. Therefore, while developing new treatments, it is important that target users be involved in the intervention design. Objective: This qualitative study aims to explore the views and preferences of young people and health care professionals regarding the development of a new computerized BA therapy for young people with low mood or depression, to ensure that the therapy was suitable for the target user. Methods: Semistructured focus groups and individual interviews were conducted with young people (those with experience in accessing support and those without) and health care professionals regarding the development of a new computerized BA therapy for young people with low mood or depression. The data were analyzed using thematic analysis. Results: A total of 27 individuals, comprising both health care professionals and young people, participated in this study. Vital information pertaining to the important components of a new therapy, including its presentation, delivery, and content, was collected. Conclusions: Variations in perspectives highlighted the need to adopt a systemic approach in therapy development by considering the opinions of young people with and without experience in accessing mental health support and health care professionals. %M 33847594 %R 10.2196/19743 %U https://www.jmir.org/2021/4/e19743 %U https://doi.org/10.2196/19743 %U http://www.ncbi.nlm.nih.gov/pubmed/33847594 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 7 %N 2 %P e26010 %T A Novel Behavioral Intervention for Rural Appalachian Cancer Survivors (weSurvive): Participatory Development and Proof-of-Concept Testing %A Porter,Kathleen J %A Moon,Katherine E %A LeBaron,Virginia T %A Zoellner,Jamie M %+ Department of Public Health Sciences, School of Medicine, University of Virginia, , Christiansburg, VA, United States, 1 4342706599, kjporter@virginia.edu %K cancer survivors %K quality of life %K behavior change %K rural %K feasibility %K Appalachia %D 2021 %7 12.4.2021 %9 Original Paper %J JMIR Cancer %G English %X Background: Addressing the modifiable health behaviors of cancer survivors is important in rural communities that are disproportionately impacted by cancer (eg, those in Central Appalachia). However, such efforts are limited, and existing interventions may not meet the needs of rural communities. Objective: This study describes the development and proof-of-concept testing of weSurvive, a behavioral intervention for rural Appalachian cancer survivors. Methods: The Obesity-Related Behavioral Intervention Trials (ORBIT) model, a systematic model for designing behavioral interventions, informed the study design. An advisory team (n=10) of community stakeholders and researchers engaged in a participatory process to identify desirable features for interventions targeting rural cancer survivors. The resulting multimodal, 13-week weSurvive intervention was delivered to 12 participants across the two cohorts. Intervention components included in-person group classes and group and individualized telehealth calls. Indicators reflecting five feasibility domains (acceptability, demand, practicality, implementation, and limited efficacy) were measured using concurrent mixed methods. Pre-post changes and effect sizes were assessed for limited efficacy data. Descriptive statistics and content analysis were used to summarize data for other domains. Results: Participants reported high program satisfaction (acceptability). Indicators of demand included enrollment of cancer survivors with various cancer types and attrition (1/12, 8%), recruitment (12/41, 30%), and attendance (median 62%) rates. Dietary (7/12, 59%) and physical activity (PA; 10/12, 83%) behaviors were the most frequently chosen behavioral targets. However, the findings indicate that participants did not fully engage in action planning activities, including setting specific goals. Implementation indicators showed 100% researcher fidelity to delivery and retention protocols, whereas practicality indicators highlighted participation barriers. Pre-post changes in limited efficacy outcomes regarding cancer-specific beliefs and knowledge and behavior-specific self-efficacy, intentions, and behaviors were in desired directions and demonstrated small and moderate effect sizes. Regarding dietary and PA behaviors, effect sizes for fruit and vegetable intake, snacks, dietary fat, and minutes of moderate-to-vigorous activity were small (Cohen d=0.00 to 0.32), whereas the effect sizes for change in PA were small to medium (Cohen d=0.22 to 0.45). Conclusions: weSurvive has the potential to be a feasible intervention for rural Appalachian cancer survivors. It will be refined and further tested based on the study findings, which also provide recommendations for other behavioral interventions targeting rural cancer survivors. Recommendations included adding additional recruitment and engagement strategies to increase demand and practicality as well as increasing accountability and motivation for participant involvement in self-monitoring activities through the use of technology (eg, text messaging). Furthermore, this study highlights the importance of using a systematic model (eg, the ORBIT framework) and small-scale proof-of-concept studies when adapting or developing behavioral interventions, as doing so identifies the intervention’s potential for feasibility and areas that need improvement before time- and resource-intensive efficacy trials. This could support a more efficient translation into practice. %M 33843597 %R 10.2196/26010 %U https://cancer.jmir.org/2021/2/e26010 %U https://doi.org/10.2196/26010 %U http://www.ncbi.nlm.nih.gov/pubmed/33843597 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e19875 %T Combining Web-Based Gamification and Physical Nudges With an App (MoveMore) to Promote Walking Breaks and Reduce Sedentary Behavior of Office Workers: Field Study %A Mamede,André %A Noordzij,Gera %A Jongerling,Joran %A Snijders,Merlijn %A Schop-Etman,Astrid %A Denktas,Semiha %+ Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University Rotterdam, Burgemeester Oudlaan 50, Rotterdam, 3062 PA, Netherlands, 31 10 408 8789, mamedesoaresbraga@essb.eur.nl %K internet %K eHealth %K mHealth %K mobile phone %K lifestyle %K obesity %K social network %K multilevel analysis %K physical exercise %D 2021 %7 12.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Sedentary behavior (SB) and lack of physical activity (PA) have been associated with poorer health outcomes and are increasingly prevalent in individuals working in sedentary occupations such as office jobs. Gamification and nudges have attracted attention as promising strategies to promote changes in health behavior. However, most effectiveness studies thus far lacked active controls, and few studies have tested interventions combining these strategies. Objective: This study investigates the effectiveness of combining a gamified digital app with physical nudges to increase PA and reduce SB in Dutch office workers. Methods: Employees in the municipality of Rotterdam (N=298) from two office locations were randomized at the location level to either a 10-week intervention, combining a 5-week gamification phase encompassing a gamified digital app with social support features and a 5-week physical nudges phase, or to an active control (ie, basic digital app with self-monitoring and goal setting). The primary outcome was the daily step count, objectively measured via accelerometers. Secondary outcomes were self-reported PA and SB measured at baseline and at 5, 10, and 14 weeks. Mixed effects models were used to analyze the effects of the intervention on the outcome measures. Results: A total of 78.5% (234/298) of participants completed the study and provided accelerometer data, whereas 36.9% (110/298) participants completed the self-report measures at 14 weeks. In the gamification phase, step count data were missing for 13.5% (473/3492) of observations in the control and 11.4% (445/3888) in the intervention condition; however, these percentages increased to 39.6% (1154/2910) and 59.6% (1932/3492) at follow-up, respectively. During the gamification phase, intervention participants increased their number of daily steps by 634 (95% CI 154.2-1113.8; P=.01) more than participants in the control group, after controlling for relevant factors. Improvements were not sustained during the physical nudges phase (P=.76) or follow-up (P=.88). Conclusions: A digital intervention with gamification and social support features significantly increased the step count of office workers compared with an active control. Physical nudges in the workplace were insufficient to promote the maintenance of behavioral changes achieved in the gamification phase. Future research should explore the long-term effectiveness of similar gamified digital interventions. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 49129401; https://www.isrctn.com/ISRCTN14881571 %M 33843593 %R 10.2196/19875 %U https://www.jmir.org/2021/4/e19875 %U https://doi.org/10.2196/19875 %U http://www.ncbi.nlm.nih.gov/pubmed/33843593 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 4 %P e26554 %T Generating Intervention Concepts for Reducing Adolescent Relationship Abuse Inequities Among Sexual and Gender Minority Youth: Protocol for a Web-Based, Longitudinal, Human-Centered Design Study %A Coulter,Robert W S %A Mitchell,Shannon %A Prangley,Kelly %A Smallwood,Seth %A Bonanno,Leyna %A Foster,Elizabeth N %A Wilson,Abby %A Miller,Elizabeth %A Chugani,Carla D %+ Department of Behavioral and Community Health Sciences, Graduate School of Public Health, University of Pittsburgh, 130 DeSoto St, Pittsburgh, PA, 15261, United States, 1 4126240647, robert.ws.coulter@pitt.edu %K sexual and gender minorities %K adolescent %K psychosocial intervention %K internet-based intervention %K intimate partner violence %D 2021 %7 12.4.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Sexual and gender minority youth (SGMY; eg, lesbian, gay, bisexual, and transgender youth) are at greater risk than their cisgender heterosexual peers for adolescent relationship abuse (ARA; physical, sexual, or psychological abuse in a romantic relationship). However, there is a dearth of efficacious interventions for reducing ARA among SGMY. To address this intervention gap, we designed a novel web-based methodology leveraging the field of human-centered design to generate multiple ARA intervention concepts with SGMY. Objective: This paper aims to describe study procedures for a pilot study to rigorously test the feasibility, acceptability, and appropriateness of using web-based human-centered design methods with SGMY to create novel, stakeholder-driven ARA intervention concepts. Methods: We are conducting a longitudinal, web-based human-centered design study with 45-60 SGMY (aged between 14 and 18 years) recruited via social media from across the United States. Using MURAL (a collaborative, visual web-based workspace) and Zoom (a videoconferencing platform), the SGMY will participate in four group-based sessions (1.5 hours each). In session 1, the SGMY will use rose-thorn-bud to individually document their ideas about healthy and unhealthy relationship characteristics and then use affinity clustering as a group to categorize their self-reported ideas based on similarities and differences. In session 2, the SGMY will use rose-thorn-bud to individually critique a universal evidence-based intervention to reduce ARA and affinity clustering to aggregate their ideas as a group. In session 3, the SGMY will use a creative matrix to generate intervention ideas for reducing ARA among them and force-rank the intervention ideas based on their potential ease of implementation and potential impact using an importance-difficulty matrix. In session 4, the SGMY will generate and refine intervention concepts (from session 3 ideations) to reduce ARA using round robin (for rapid iteration) and concept poster (for fleshing out ideas more fully). We will use content analyses to document the intervention concepts. In a follow-up survey, the SGMY will complete validated measures about the feasibility, acceptability, and appropriateness of the web-based human-centered design methods (a priori benchmarks for success: means >3.75 on each 5-point scale). Results: This study was funded in February 2020. Data collection began in August 2020 and will be completed by April 2021. Conclusions: Through rigorous testing of the feasibility of our web-based human-centered design methodology, our study may help demonstrate the use of human-centered design methods to engage harder-to-reach stakeholders and actively involve them in the co-creation of relevant interventions. Successful completion of this project also has the potential to catalyze intervention research to address ARA inequities for SGMY. Finally, our approach may be transferable to other populations and health topics, thereby advancing prevention science and health equity. International Registered Report Identifier (IRRID): DERR1-10.2196/26554 %M 33843601 %R 10.2196/26554 %U https://www.researchprotocols.org/2021/4/e26554 %U https://doi.org/10.2196/26554 %U http://www.ncbi.nlm.nih.gov/pubmed/33843601 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e24690 %T Social Network Analysis of the Effects of a Social Media–Based Weight Loss Intervention Targeting Adults of Low Socioeconomic Status: Single-Arm Intervention Trial %A Xu,Ran %A Cavallo,David %+ Department of Allied Health Sciences, College of Agriculture, Health and Natural Resources, University of Connecticut, Koons Hall 326, Storrs, CT, , United States, 1 860 486 2945, Ran.2.xu@uconn.edu %K weight loss intervention %K social media intervention %K electronic health %K social network analysis %D 2021 %7 9.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Obesity is a known risk factor for cardiovascular disease risk factors, including hypertension and type II diabetes. Although numerous weight loss interventions have demonstrated efficacy, there is considerably less evidence about the theoretical mechanisms through which they work. Delivering lifestyle behavior change interventions via social media provides unique opportunities for understanding mechanisms of intervention effects. Server data collected directly from web-based platforms can provide detailed, real-time behavioral information over the course of intervention programs that can be used to understand how interventions work. Objective: The objective of this study was to demonstrate how social network analysis can facilitate our understanding of the mechanisms underlying a social media–based weight loss intervention. Methods: We performed secondary analysis by using data from a pilot study that delivered a dietary and physical activity intervention to a group of participants via Facebook. We mapped out participants’ interaction networks over the 12-week intervention period and linked participants’ network characteristics (eg, in-degree, out-degree, network constraint) to participants’ changes in theoretical mediators (ie, dietary knowledge, perceived social support, self-efficacy) and weight loss by using regression analysis. We also performed mediation analyses to explore how the effects of social network measures on weight loss could be mediated by the aforementioned theoretical mediators. Results: In this analysis, 47 participants from 2 waves completed the study and were included. We found that increases in the number of posts, comments, and reactions significantly predicted weight loss (β=–.94, P=.04); receiving comments positively predicted changes in self-efficacy (β=7.81, P=.009), and the degree to which one’s network neighbors are tightly connected with each other weakly predicted changes in perceived social support (β=7.70, P=.08). In addition, change in self-efficacy mediated the relationship between receiving comments and weight loss (β=–.89, P=.02). Conclusions: Our analyses using data from this pilot study linked participants’ network characteristics with changes in several important study outcomes of interest such as self-efficacy, social support, and weight. Our results point to the potential of using social network analysis to understand the social processes and mechanisms through which web-based behavioral interventions affect participants’ psychological and behavioral outcomes. Future studies are warranted to validate our results and to further explore the relationship between network dynamics and study outcomes in similar and larger trials. %M 33835033 %R 10.2196/24690 %U https://www.jmir.org/2021/4/e24690 %U https://doi.org/10.2196/24690 %U http://www.ncbi.nlm.nih.gov/pubmed/33835033 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e24639 %T Perspectives of Inpatients With Cirrhosis and Caregivers on Using Health Information Technology: Cross-sectional Multicenter Study %A Acharya,Chathur %A Sehrawat,Tejasav S %A McGuire,Deborah B %A Shaw,Jawaid %A Fagan,Andrew %A McGeorge,Sara %A Olofson,Amy %A White,Melanie B %A Gavis,Edith %A Kamath,Patrick S %A Bergstrom,Lori %A Bajaj,Jasmohan Singh %+ Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, 1201 Broad Rock Boulevard, Richmond, VA, 23249, United States, 1 804 675 5802, jasmohan.bajaj@vcuhealth.org %K hepatic encephalopathy %K cirrhosis %K outcomes %K acceptance %K PatientBuddy %K ascites %K readmissions %K hepatic %K encephalopathy %D 2021 %7 9.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Health information technology (IT) interventions to decrease readmissions for cirrhosis may be limited by patient-associated factors. Objective: The aim of this study was to determine perspectives regarding adoption versus refusal of health IT interventions among patient-caregiver dyads. Methods: Inpatients with cirrhosis and their caregivers were approached to participate in a randomized health IT intervention trial requiring daily contact with research teams via the Patient Buddy app. This app focuses on ascites, medications, and hepatic encephalopathy over 30 days. Regression analyses for characteristics associated with acceptance were performed. For those who declined, a semistructured interview was performed with themes focused on caregivers, protocol, transport/logistics, technology demands, and privacy. Results: A total of 349 patient-caregiver dyads were approached (191 from Virginia Commonwealth University, 56 from Richmond Veterans Affairs Medical Center, and 102 from Mayo Clinic), 87 of which (25%) agreed to participate. On regression, dyads agreeing included a male patient (odds ratio [OR] 2.08, P=.01), gastrointestinal bleeding (OR 2.3, P=.006), or hepatic encephalopathy admission (OR 2.0, P=.01), whereas opioid use (OR 0.46, P=.03) and alcohol-related etiology (OR 0.54, P=.02) were associated with refusal. Race, study site, and other admission reasons did not contribute to refusing participation. Among the 262 dyads who declined randomization, caregiver reluctance (43%), perceived burden (31%), technology-related issues (14%), transportation/logistics (10%), and others (4%), but not privacy, were highlighted as major concerns. Conclusions: Patients with cirrhosis admitted with hepatic encephalopathy and gastrointestinal bleeding without opioid use or alcohol-related etiologies were more likely to participate in a health IT intervention focused on preventing readmissions. Caregiver and study burden but not privacy were major reasons to decline participation. Reducing perceived patient-caregiver burden and improving communication may improve participation. Trial Registration: ClinicalTrials.gov NCT03564626; https://www.clinicaltrials.gov/ct2/show/NCT03564626 %M 33744844 %R 10.2196/24639 %U https://www.jmir.org/2021/4/e24639 %U https://doi.org/10.2196/24639 %U http://www.ncbi.nlm.nih.gov/pubmed/33744844 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e22399 %T A Digital Patient-Provider Communication Intervention (InvolveMe): Qualitative Study on the Implementation Preparation Based on Identified Facilitators and Barriers %A Seljelid,Berit %A Varsi,Cecilie %A Solberg Nes,Lise %A Øystese,Kristin Astrid %A Børøsund,Elin %+ Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Box 4950 Nydalen, Oslo, N-0424, Norway, 47 22894357, elin.borosund@rr-research.no %K eHealth %K digital communication %K secure messages %K digital symptom assessment %K implementation %K tailoring %K Consolidated Framework for Implementation Research %K CFIR %K facilitators %K barriers %K stakeholders %D 2021 %7 8.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic health conditions are affecting an increasing number of individuals, who experience various symptoms that decrease their quality of life. Digital communication interventions that enable patients to report their symptoms have been shown to positively impact chronic disease management by improving access to care, patient-provider communication, clinical outcomes, and health-related quality of life. These interventions have the potential to prepare patients and health care providers (HCPs) before visits and improve patient-provider communication. Despite the recent rapid development and increasing number of digital communication interventions that have shown positive research results, barriers to realizing the benefits offered through these types of interventions still exist. Objective: The aim of this study is to prepare for the implementation of a digital patient-provider communication intervention in the daily workflow at 2 outpatient clinics by identifying potential determinants of implementation using the Consolidated Framework for Implementation Research (CFIR) to tailor the use of digital communication intervention to the intended context and identify key aspects for an implementation plan. Methods: A combination of focus groups, workshops, and project steering committee meetings was conducted with HCPs (n=14) and patients (n=2) from 2 outpatient clinics at a university hospital. The CFIR was used to guide data collection and analysis. Transcripts, written minutes, and notes were analyzed and coded into 5 CFIR domains using thematic analysis. Results: Data were examined and analyzed into 18 CFIR constructs relevant to the study purpose. On the basis of the identified determinants, important intervention tailoring includes adjustments to the digital features and adjustments to fit the clinical workflow and a decision to conduct a future pilot study. Furthermore, it was decided to provide the intervention to patients as early as possible in their disease trajectory, with tailored information about its use. Key aspects for the implementation plan encompassed maintaining the identified engagement and positive attitude, involving key stakeholders in the implementation process, and providing the needed support and training. Conclusions: This study offers insight into the involvement of stakeholders in the tailoring and implementation planning of a digital communication intervention in clinical practice. Stakeholder involvement in the identification of implementation facilitators and barriers can contribute to the tailoring of digital communication interventions and how they are used and can also inform systematic and targeted implementation planning. %M 33830063 %R 10.2196/22399 %U https://www.jmir.org/2021/4/e22399 %U https://doi.org/10.2196/22399 %U http://www.ncbi.nlm.nih.gov/pubmed/33830063 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 4 %P e21444 %T Reasons for Discontinuing Active Participation on the Internet Forum Tinnitus Talk: Mixed Methods Citizen Science Study %A Budimir,Sanja %A Kuska,Martin %A Spiliopoulou,Myra %A Schlee,Winfried %A Pryss,Rüdiger %A Andersson,Gerhard %A Goedhart,Hazel %A Harrison,Stephen %A Vesala,Markku %A Hegde,Gourish %A Langguth,Berthold %A Pieh,Christoph %A Probst,Thomas %+ Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Dr.-Karl-Dorrek-Strasse 30, Krems an der Donau, 3500, Austria, 43 27328932531, sanja.budimir@donau-uni.ac.at %K tinnitus %K Tinnitus Talk %K Internet forum %K dropout %K reasons for discontinuation %D 2021 %7 8.4.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Tinnitus Talk is a nonprofit online self-help forum. Asking inactive users about their reasons for discontinued usage of health-related online platforms such as Tinnitus Talk is important for quality assurance. Objective: The aim of this study was to explore reasons for discontinued use of Tinnitus Talk, and their associations to the perceptions of Tinnitus Talk and the age of users who ceased logging on to the platform. Methods: Initially, 13,745 users that did not use Tinnitus Talk within the previous 2 months were contacted and the response rate was 20.47% (n=2814). After dataset filtering, a total of 2172 past members of Tinnitus Talk were included in the analyses. Nine predefined reasons for discontinued usage of Tinnitus Talk were included in the survey as well as one open question. Moreover, there were 14 predefined questions focusing on perception of Tinnitus Talk (usefulness, content, community, and quality of members’ posts). Mixed methods analyses were performed. Frequencies and correlation coefficients were calculated for quantitative data, and grounded theory methodology was utilized for exploration of the qualitative data. Results: Quantitative analysis revealed reasons for discontinued use of Tinnitus Talk as well as associations of these reasons with perceptions of Tinnitus Talk and age. Among the eight predefined reasons for discontinued use of Tinnitus Talk, the most frequently reported was not finding the information they were looking for (451/2695, 16.7%). Overall, the highest rated perception of Tinnitus Talk was content-related ease of understanding (mean 3.9, SD 0.64). A high number (nearly 40%) of participants provided additional free text explaining why they discontinued use. Qualitative analyses identified a total of 1654 specific reasons, more than 93% of which (n=1544) could be inductively coded. The coding system consisted of 33 thematically labeled codes clustered into 10 categories. The most frequent additional reason for discontinuing use was thinking that there is no cure or help for tinnitus symptoms (375/1544, 24.3%). Significant correlations (P<.001) were observed between reasons for discontinued usage and perception of Tinnitus Talk. Several reasons for discontinued usage were associated with the examined dimensions of perception of Tinnitus Talk (usefulness, content, community, as well as quality of members’ posts). Moreover, significant correlations (P<.001) between age and reasons for discontinued use were found. Older age was associated with no longer using Tinnitus Talk because of not finding what they were looking for. In addition, older participants had a generally less positive perception of Tinnitus Talk than younger participants (P<.001). Conclusions: This study contributes to understanding the reasons for discontinued usage of online self-help platforms, which are typically only reported according to the dropout rates. Furthermore, specific groups of users who did not benefit from Tinnitus Talk were identified, and several practical implications for improvement of the structure, content, and goals of Tinnitus Talk were suggested. %M 33830060 %R 10.2196/21444 %U https://formative.jmir.org/2021/4/e21444 %U https://doi.org/10.2196/21444 %U http://www.ncbi.nlm.nih.gov/pubmed/33830060 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 7 %N 4 %P e22759 %T Respondent Characteristics and Dietary Intake Data Collected Using Web-Based and Traditional Nutrition Surveillance Approaches: Comparison and Usability Study %A Timon,Claire M %A Walton,Janette %A Flynn,Albert %A Gibney,Eileen R %+ Institute of Food and Health, University College Dublin, Institute of Food and Health, University College Dublin, Belfield, Dublin, 4, Ireland, 353 17162819, eileen.gibney@ucd.ie %K diet %K survey and questionnaire %K technology %K nutrition surveillance %D 2021 %7 7.4.2021 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: There are many constraints to conducting national food consumption surveys for national nutrition surveillance, including cost, time, and participant burden. Validated web-based dietary assessment technologies offer a potential solution to many of these constraints. Objective: This study aims to investigate the feasibility of using a previously validated, web-based, 24-hour recall dietary assessment tool (Foodbook24) for nutrition surveillance by comparing the demographic characteristics and the quality of dietary intake data collected from a web-based cohort of participants in Ireland to those collected from the most recent Irish National Adult Nutrition Survey (NANS). Methods: Irish adult participants (aged ≥18 years) were recruited to use Foodbook24 (a web-based tool) between March and October 2016. Demographic and dietary intake (assessed by means of 2 nonconsecutive, self-administered, 24-hour recalls) data were collected using Foodbook24. Following the completion of the study, the dietary intake data collected from the web-based study were statistically weighted to represent the age-gender distribution of intakes reported in the NANS (2008-2010) to facilitate the controlled comparison of intake data. The demographic characteristics of the survey respondents were investigated using descriptive statistics. The controlled comparison of weighted mean daily nutrient intake data collected from the Foodbook24 web-based study (329 plausible reporters of a total of 545 reporters) and the mean daily nutrient intake data collected from the NANS (1051 plausible reporters from 1500 reporters) was completed using the Wilcoxon–Mann-Whitney U test in Creme Nutrition software. Results: Differences between the demographic characteristics of the survey participants across the 2 surveys were observed. Notable differences included a lower proportion of adults aged ≥65 years and a higher proportion of females who participated in the web-based Foodbook24 study relative to the NANS study (P<.001). Similar ranges of mean daily intake for the majority of nutrients and food groups were observed (eg, energy [kilocalorie per day] and carbohydrate [gram per day]), although significant differences for some nutrients (eg, riboflavin [mg/10 MJ], P<.001 and vitamin B12 [µg/10 MJ], P<.001) and food groups were identified. A high proportion of participants (200/425, 47.1%) reported a willingness to continue using Foodbook24 for an additional 6 months. Conclusions: These findings suggest that by using targeted recruitment strategies in the future to ensure the recruitment of a more representative sample, there is potential for web-based methodologies such as Foodbook24 to be used for nutrition surveillance efforts in Ireland. %M 33825694 %R 10.2196/22759 %U https://publichealth.jmir.org/2021/4/e22759 %U https://doi.org/10.2196/22759 %U http://www.ncbi.nlm.nih.gov/pubmed/33825694 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e21466 %T Internet-Based Cognitive Behavioral Therapy for Informal Caregivers: Randomized Controlled Pilot Trial %A Biliunaite,Ieva %A Kazlauskas,Evaldas %A Sanderman,Robbert %A Truskauskaite-Kuneviciene,Inga %A Dumarkaite,Austeja %A Andersson,Gerhard %+ Department of Behavioural Sciences and Learning, Linköping University, Campus Valla, Linköping, 581 83, Sweden, 46 13 28 69 10, ieva.biliunaite@liu.se %K caregiver burden %K informal caregivers %K internet intervention %K cognitive behavioral therapy %K eHealth %K mHealth %D 2021 %7 7.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Caregiving for a family member can result in reduced well-being for the caregiver. Internet-delivered cognitive behavioral therapy (ICBT) may be one way to support this population. This is especially the case for caregivers in countries with limited resources, but high demand for psychological services. Objective: In this study we evaluated the effects of a therapist-guided 8-week-long ICBT intervention for informal caregivers. Methods: In total, 63 participants were recruited online and randomized either to the intervention or to the wait-list control group. The main study outcome was the Caregiver Burden Inventory (CBI). Secondary outcomes included measures of caregiver depression, anxiety, stress, and quality of life. Results: Moderate between-group effect sizes were observed for the CBI measure, in favor of the intervention group, with a Cohen d=–0.70 for the intention-to-treat analysis. Analyses of the subscales of the CBI showed significant reductions on the subscales of Development and Physical Health. Moderate reductions were found for depression and anxiety scores as indicated by the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) scores. Large between-group effects were observed for reduction in stress and increase in quality of life as indicated by the Perceived Stress Scale-14 (PSS-14), The Brunnsviken Brief Quality of Life Scale (BBQ), and The World Health Organization-Five Well-Being Index (WHO-5). In addition, participants experienced little to no difficulty in using the program and were mostly satisfied with the intervention’s platform and the choice of content. Conclusions: This is the first internet intervention study for informal caregivers in Lithuania. The results suggest that therapist-guided ICBT can be effective in reducing caregiver burden, anxiety, depression, stress, and improving quality of life. Trial Registration: ClinicalTrials.gov NCT04052724; https://clinicaltrials.gov/ct2/show/NCT04052724 %M 33825687 %R 10.2196/21466 %U https://www.jmir.org/2021/4/e21466 %U https://doi.org/10.2196/21466 %U http://www.ncbi.nlm.nih.gov/pubmed/33825687 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e25502 %T The Healing Hearts Together Randomized Controlled Trial and the COVID-19 Pandemic: A Tutorial for Transitioning From an In-Person to a Web-Based Intervention %A Lalande,Kathleen %A Greenman,Paul S %A Bouchard,Karen %A Johnson,Susan M %A Tulloch,Heather %+ Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, ON, K1Y 4W7, Canada, 1 613 696 7000 ext 19705, hetulloch@ottawaheart.ca %K web-based intervention %K internet-based intervention %K randomized controlled trial %K COVID-19 %K research %K tutorial %K digital medicine %K behavioral medicine %K telehealth %K telemedicine %K cardiovascular rehabilitation %D 2021 %7 6.4.2021 %9 Tutorial %J J Med Internet Res %G English %X Supportive couple relationships are associated with reduced risk of chronic illness development, such as cardiovascular disease, as well as improved secondary prevention. Healing Hearts Together (HHT) is an 8-week couples-based intervention designed to improve relationship quality, mental health, quality of life, and cardiovascular health among couples in which one partner has experienced a cardiac event. A randomized controlled trial began in October 2019 to test the efficacy of the in-person, group-based HHT program as compared to usual care. In March of 2020, all recruitment, assessments, and interventions halted due to the COVID-19 pandemic. Guided by optimal virtual care principles, as well as by Hom and colleagues’ four-stage framework—consultation, adaptation, pilot-testing, and test launch—this paper is a tutorial for the step-by-step transition planning and implementation of a clinical research intervention from an in-person to a web-based format, using the HHT program as an example. Clinical and research considerations are reviewed, including (1) privacy, (2) therapeutic aspects of the intervention, (3) group cohesion, (4) research ethics, (5) participant recruitment, (6) assessment measures, (7) data collection, and (8) data analyses. This tutorial can assist clinical researchers in transitioning their research programs to a web-based format during the pandemic and beyond. %M 33729984 %R 10.2196/25502 %U https://www.jmir.org/2021/4/e25502 %U https://doi.org/10.2196/25502 %U http://www.ncbi.nlm.nih.gov/pubmed/33729984 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e24260 %T Moderated Online Social Therapy for Young People With Active Suicidal Ideation: Qualitative Study %A Bailey,Eleanor %A Robinson,Jo %A Alvarez-Jimenez,Mario %A Nedeljkovic,Maja %A Valentine,Lee %A Bendall,Sarah %A D'Alfonso,Simon %A Gilbertson,Tamsyn %A McKechnie,Ben %A Rice,Simon %+ Orygen, Locked Bag 10, 35 Poplar Road, Parkville, 3052, Australia, 61 412483600, eleanor.bailey@orygen.org.au %K suicide %K youth %K social media %K internet-based intervention %D 2021 %7 5.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based interventions are a promising approach to support youth at risk of suicide, and those incorporating peer-to-peer social networking may have the added potential to target interpersonal states of perceived burdensomeness and thwarted belongingness. Owing to feasibility and safety concerns, including fear of contagion, this had not been tested until recently. In 2018, we conducted a pilot evaluation to test the feasibility, safety, and acceptability of a Moderated Online Social Therapy intervention, called Affinity, with a sample of young people with active suicidal ideation. Objective: The aim of this study is to report qualitative data collected from study participants regarding their experience of the web-based social network and the consequent safety features. Methods: Affinity is a closed website incorporating 3 key components: therapeutic content delivered via comics, peer-to-peer social networking, and moderation by peers and clinicians. Semistructured interviews were conducted with 17 young people who participated in the pilot study after 8 weeks of exposure to the intervention. Interview data from 2 young people who did not use Affinity were excluded from the analysis. The interviews were analyzed using thematic analysis, with the frequency of responses characterized using the consensual qualitative research method. The results are reported in accordance with the Consolidated Criteria for Reporting Qualitative Research checklist. Results: A total of 4 overarching themes were identified: a safe and supportive environment, the importance of mutual experiences, difficulty engaging and connecting, and the pros and cons of banning discussions about suicide. Interestingly, although Affinity was perceived to be safe and free of judgment, concerns about negative evaluation and triggering others were significant barriers to posting on the social network. Participants generally supported the banning of conversations about suicide, although for some this was perceived to reinforce stigma or was associated with frustration and distress. Conclusions: The results not only support the safety and potential therapeutic benefit of the social networking aspect of Affinity but also highlight several implementation challenges. There is a need to carefully balance the need for stringent safety and design features while ensuring that the potential for therapeutic benefit is maximized. %M 33818392 %R 10.2196/24260 %U https://www.jmir.org/2021/4/e24260 %U https://doi.org/10.2196/24260 %U http://www.ncbi.nlm.nih.gov/pubmed/33818392 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e19439 %T A Mobile App for Self-management of Urgency and Mixed Urinary Incontinence in Women: Randomized Controlled Trial %A Wadensten,Towe %A Nyström,Emma %A Franzén,Karin %A Lindam,Anna %A Wasteson,Elisabet %A Samuelsson,Eva %+ Family Medicine, Department of Public Health and Clinical Medicine, Umeå University, Umeå, SE-90187, Sweden, 46 907855000, towe.wadensten@umu.se %K eHealth %K mHealth %K urinary incontinence %K urgency urinary incontinence %K mixed urinary incontinence %K self-management %K mobile app %K smartphone app %K women %D 2021 %7 5.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Many women experience urgency (UUI) and mixed (MUI) urinary incontinence but commonly hesitate to seek care. Treatment access and self-management for these conditions can be supported through eHealth approaches. Objective: This study aimed to investigate the efficacy of the mobile app Tät II for self-management of UUI and MUI in women. Methods: This randomized controlled trial included women ≥18 years old with UUI or MUI and ≥2 leakages per week. Those with red-flag symptoms were excluded. Participants were recruited via analog and digital advertisements and screened for initial selection through a web-based questionnaire. Data were collected using another questionnaire and a 2-day bladder diary. A telephone interview confirmed the symptom diagnosis. Participants were randomized (1:1) to receive access to a treatment app (including pelvic floor muscle training, bladder training, psychoeducation, lifestyle advice, tailored advice, exercise log, reinforcement messages, and reminders) or an information app (control group), with no external treatment guidance provided. The primary outcome was incontinence symptoms at the 15-week follow-up, measured using the International Consultation on Incontinence Questionnaire (ICIQ)−Urinary Incontinence Short Form (ICIQ-UI SF). Urgency symptoms were assessed using the ICIQ−Overactive Bladder Module (ICIQ-OAB) and quality of life using the ICIQ−Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). Incontinence episode frequency (IEF) was calculated per bladder diary entries. Improvement was measured using the Patient’s Global Impression of Improvement. All outcomes were self-reported. Cure was defined as no leakages per the bladder diary. Intention-to-treat analysis was performed. Results: Between April 2017 and March 2018, 123 women (mean age 58.3, SD 9.6 years) were randomized to the treatment (n=60, 2 lost to follow-up) or information (n=63) group. Of these, 35 (28%) women had UUI, and 88 (72%) had MUI. Mean ICIQ-UI SF score at follow-up was lower in the treatment group than in the information group (estimated difference −3.1, 95% CI −4.8 to −1.3). The estimated between-group difference was −1.8 (95% CI −2.8 to −0.99) for mean ICIQ-OAB score and −6.3 (95% CI −10.5 to −2.1) for the mean ICIQ-LUTSqol score at follow-up. IEF reduction from baseline to follow-up was greater in the treatment group (−10.5, IQR −17.5 to −3.5) than in the information group (P<.001). Improvement was reported by 87% (52/60) of treatment group participants and by 30% (19/63) of information group participants. The cure rate was 32% in the treatment group, and 6% in the information group (odds ratio 5.4, 95% CI 1.9-15.6; P=.002). About 67% (40/60) of the treatment group participants used the app more than thrice a week. Conclusions: The treatment app was effective for improving urgency and mixed incontinence in women. When self-management is appropriate, this app may be a good alternative to pharmacological treatment or other conservative management, thus increasing access to care. Trial Registration: ClinicalTrials.gov NCT03097549; https://clinicaltrials.gov/ct2/show/NCT03097549 %M 33818395 %R 10.2196/19439 %U https://www.jmir.org/2021/4/e19439 %U https://doi.org/10.2196/19439 %U http://www.ncbi.nlm.nih.gov/pubmed/33818395 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e24602 %T Blended Self-Management Interventions to Reduce Disease Burden in Patients With Chronic Obstructive Pulmonary Disease and Asthma: Systematic Review and Meta-analysis %A Song,Xiaoyue %A Hallensleben,Cynthia %A Zhang,Weihong %A Jiang,Zongliang %A Shen,Hongxia %A Gobbens,Robbert J J %A Kleij,Rianne M J J Van Der %A Chavannes,Niels H %A Versluis,Anke %+ Department of Public Health and Primary Care, Leiden University Medical Center, Albinusdreef 2, Leiden, 2333 ZA, Netherlands, 31 613836216, x.song@lumc.nl %K blended intervention %K COPD %K asthma %K meta-analysis %K systematic review %D 2021 %7 31.3.2021 %9 Review %J J Med Internet Res %G English %X Background: Chronic obstructive pulmonary disease (COPD) and asthma have a high prevalence and disease burden. Blended self-management interventions, which combine eHealth with face-to-face interventions, can help reduce the disease burden. Objective: This systematic review and meta-analysis aims to examine the effectiveness of blended self-management interventions on health-related effectiveness and process outcomes for people with COPD or asthma. Methods: PubMed, Web of Science, COCHRANE Library, Emcare, and Embase were searched in December 2018 and updated in November 2020. Study quality was assessed using the Cochrane risk of bias (ROB) 2 tool and the Grading of Recommendations, Assessment, Development, and Evaluation. Results: A total of 15 COPD and 7 asthma randomized controlled trials were included in this study. The meta-analysis of COPD studies found that the blended intervention showed a small improvement in exercise capacity (standardized mean difference [SMD] 0.48; 95% CI 0.10-0.85) and a significant improvement in the quality of life (QoL; SMD 0.81; 95% CI 0.11-1.51). Blended intervention also reduced the admission rate (relative ratio [RR] 0.61; 95% CI 0.38-0.97). In the COPD systematic review, regarding the exacerbation frequency, both studies found that the intervention reduced exacerbation frequency (RR 0.38; 95% CI 0.26-0.56). A large effect was found on BMI (d=0.81; 95% CI 0.25-1.34); however, the effect was inconclusive because only 1 study was included. Regarding medication adherence, 2 of 3 studies found a moderate effect (d=0.73; 95% CI 0.50-0.96), and 1 study reported a mixed effect. Regarding self-management ability, 1 study reported a large effect (d=1.15; 95% CI 0.66-1.62), and no effect was reported in that study. No effect was found on other process outcomes. The meta-analysis of asthma studies found that blended intervention had a small improvement in lung function (SMD 0.40; 95% CI 0.18-0.62) and QoL (SMD 0.36; 95% CI 0.21-0.50) and a moderate improvement in asthma control (SMD 0.67; 95% CI 0.40-0.93). A large effect was found on BMI (d=1.42; 95% CI 0.28-2.42) and exercise capacity (d=1.50; 95% CI 0.35-2.50); however, 1 study was included per outcome. There was no effect on other outcomes. Furthermore, the majority of the 22 studies showed some concerns about the ROB, and the quality of evidence varied. Conclusions: In patients with COPD, the blended self-management interventions had mixed effects on health-related outcomes, with the strongest evidence found for exercise capacity, QoL, and admission rate. Furthermore, the review suggested that the interventions resulted in small effects on lung function and QoL and a moderate effect on asthma control in patients with asthma. There is some evidence for the effectiveness of blended self-management interventions for patients with COPD and asthma; however, more research is needed. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42019119894; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=119894 %M 33788700 %R 10.2196/24602 %U https://www.jmir.org/2021/3/e24602 %U https://doi.org/10.2196/24602 %U http://www.ncbi.nlm.nih.gov/pubmed/33788700 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e21839 %T A Uniquely Targeted, Mobile App-Based HIV Prevention Intervention for Young Transgender Women: Adaptation and Usability Study %A Kuhns,Lisa M %A Hereth,Jane %A Garofalo,Robert %A Hidalgo,Marco %A Johnson,Amy K %A Schnall,Rebecca %A Reisner,Sari L %A Belzer,Marvin %A Mimiaga,Matthew J %+ Ann & Robert H Lurie Children's Hospital of Chicago, Potocsnak Family Division of Adolescent and Young Adult Medicine, 225 E Chicago Avenue, Box 161, Chicago, IL, 60611, United States, 1 312 227 7760, lkuhns@luriechildrens.org %K transgender persons %K HIV %K mobile app %K mHealth %K mobile phone %D 2021 %7 31.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Young transgender women (YTW) are a key population for HIV-related risk reduction, yet very few interventions have been developed to meet their needs. Mobile health interventions with the potential for both efficacy and wide reach are a promising strategy to reduce HIV risk among YTW. Objective: This study aims to adapt an efficacious group-based intervention to a mobile app, Project LifeSkills, to reduce HIV risk among YTW, and to test its acceptability and usability. Methods: The group-based intervention was adapted to a mobile app, LifeSkills Mobile, with input from an expert advisory group and feedback from YTW collected during user-centered design sessions. A beta version of the app was then tested in a usability evaluation using a think-aloud protocol with debriefing interviews, recordings of screen activity, and assessments of usability via the Post-Study System Usability Questionnaire (PSSUQ) and the Health Information Technology Usability Evaluation Scale (Health-ITUES). Results: YTW (n=8; age: mean 24 years, SD 3 years; racial or ethnic minority: 7/8, 88%) provided feedback on the app prototype in design sessions and then tested a beta version of the app in a usability trial (n=10; age: mean 24 years, SD 3 years; racial or ethnic minority: 8/10, 80%). Both usability ratings (Health-ITUES: mean 4.59, SD 0.86; scale range: 1-5) and ratings for satisfaction and accessibility (PSSUQ: mean 4.64, SD 0.90; scale range 1-5) were in the good to excellent range. No functional bugs were identified, and all mobile activities were deployed as expected. Participant feedback from the usability interviews indicated very good salience of the intervention content among the focal population. Participants’ suggestions to further increase app engagement included adding animation, adding audio, and reducing the amount text. Conclusions: We conclude that the LifeSkills Mobile app is a highly usable and engaging mobile app for HIV prevention among YTW. %M 33787503 %R 10.2196/21839 %U https://www.jmir.org/2021/3/e21839 %U https://doi.org/10.2196/21839 %U http://www.ncbi.nlm.nih.gov/pubmed/33787503 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 3 %P e24871 %T Optimizing Engagement in an Online Dietary Intervention for Depression (My Food & Mood Version 3.0): Cohort Study %A Young,Claire Louise %A Mohebbi,Mohammadreza %A Staudacher,Heidi M %A Kay-Lambkin,Frances %A Berk,Michael %A Jacka,Felice Nellie %A O'Neil,Adrienne %+ Food & Mood Centre, Institute for Mental and Physical Health and Clinical Translation, Deakin University, PO Box 281, Geelong, Victoria, 3220, Australia, 61 406754668, youngc@deakin.edu.au %K online intervention %K nutritional psychiatry %K depression %K low mood %K dietary intervention %K eHealth %K mHealth %K dietary intervention %K engagement %K nonusage attrition %D 2021 %7 31.3.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: Online interventions can be a cost-effective and efficient way to deliver programs to large numbers of people regardless of geographic location. However, attrition in web-based interventions is often an issue. Developing ways to keep participants engaged is important for ensuring validity and limiting potential biases. We developed a web-based dietary intervention as part of The My Food & Mood study which aimed to optimize ways to engage participants with low mood or depressive symptoms to promote dietary behavior change. Different versions of the My Food & Mood program were tested during optimization. Iterations were developed based on user feedback and usage analysis. Objective: The purpose of this study was to compare engagement and nonusage attrition across 4 program iterations—which differed by platform format, delivery mode, and activity type—to create an optimized version. Methods: Each program version contained modular videos with key activities with respect to implementing behavior change techniques of equivalent levels of required participation and length: version 1.0, desktop program and smartphone app; version 2.1, desktop or smartphone program; version 2.2, desktop program; and version 3.0, smartphone app. Adults with PHQ-8 scores of 5 or greater were recruited online and assigned to 1 of the 4 versions. Participants were asked to use the program for 8 weeks and complete measures at weeks 4 and 8. Engagement data were collected from the web-based platform system logs and customized reports. Cox regression survival analysis examined nonusage attrition and Kruskal-Wallis tests compared engagement across each cohort. Results: A total of 614 adults participated. Kruskal-Wallis tests showed significant differences across the 4 cohorts in all engagement measures. The smartphone app (version 3.0) had the greatest engagement as measured by weeks engaged, total usage time, total time key activities, number of active sessions, percentage of activities completed against protocol, goals completed, and percentage of videos watched. Cox regression multivariate survival analysis showed referral from a health practitioner (hazard ratio [HR] 0.344, P=.001) and greater proficiency with computers (HR 0.796, P=.049) reduced the risk of nonusage attrition. Computer confidence was associated with an increased risk of nonusage attrition. Conclusions: My Food & Mood version 3.0, a dietary intervention delivered via smartphone app with self-monitoring tools for diet quality and mood monitoring, was the version with greatest engagement in a population with low mood or depression. The iterative design techniques employed and analysis of feedback from participants resulted in a program that achieved lower rates of nonusage attrition and higher rates of intensity of use. %M 33787501 %R 10.2196/24871 %U https://mental.jmir.org/2021/3/e24871 %U https://doi.org/10.2196/24871 %U http://www.ncbi.nlm.nih.gov/pubmed/33787501 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e25208 %T Comparative Success of Recruitment Strategies for an Exercise Intervention Trial Among Women With Polycystic Ovary Syndrome: Observational Study %A Benham,Jamie L %A Booth,Jane E %A Friedenreich,Christine M %A Rabi,Doreen M %A Sigal,Ronald J %+ Department of Medicine, Cumming School of Medicine, University of Calgary, Richmond Road Diagnostic and Treatment Centre, Room 1898, 1820 Richmond Road SW, Calgary, AB, T2T 5C7, Canada, 1 403 955 8327, rsigal@ucalgary.ca %K aerobic exercise %K exercise %K exercise training %K ovary %K polycystic ovary syndrome %K recruitment %K well-being %K women’s health %D 2021 %7 30.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Effective and efficient participant recruitment is a key determinant of the success of a research program. Previously reported recruitment strategies have displayed variable success rates in studies on women with polycystic ovary syndrome (PCOS). Objective: This study aimed to evaluate the effectiveness and cost per participant of the recruitment strategies that we used in a prospective randomized controlled trial to examine the effects of exercise training among inactive women with PCOS, who are aged 18-40 years. Methods: The 4 recruitment methods we used were as follows: (1) referral by health care providers or by word of mouth, (2) media (eg, local newspaper stories and radio interviews), (3) Facebook advertisements, and (4) unpaid advertisements including posters and websites. The proportions of potential, eligible, and enrolled participants recruited with each method were determined and compared using tests of proportion. The time investment and cost per participant enrolled were calculated for each recruitment strategy. Results: Of 200 potential participants screened, 98 (49%) were recruited from unpaid advertisements (posters and websites), 70 (35%) from Facebook advertisements, 16 (8%) by referral, and 16 (8%) from traditional media (newspaper and radio). Every potential participant was recruited from separate means (ie, no participant was approached through more than one recruitment method). A total of 109 (54.5%) women were deemed eligible for participation in the trial, and 60 (30.0%) were enrolled. The proportion of potential participants who completed the trial was higher for those recruited from traditional media than from Facebook advertisements (n=7/16, 44% vs n=13/70, 19%, respectively; P=.03) or unpaid advertisements (n=7/16, 44% vs n=13/98, 13%, respectively; P=.002). The cost per participant was Can $18.21 (US $14.46) for Facebook advertisements and Can $43.88 (US $34.85) for unpaid advertisements. There were no direct trial costs for referrals or traditional media. Conclusions: For this trial, each method was important for recruiting inactive women with PCOS because no participant reported learning about the trial through more than one method. Unpaid advertisements and Facebook advertisements helped recruit the largest number of participants in the trial, the former resulting in a higher cost per participant than the latter. Trial Registration: ClinicalTrials.gov NCT03362918; https://clinicaltrials.gov/ct2/show/NCT03362918 %M 33783363 %R 10.2196/25208 %U https://www.jmir.org/2021/3/e25208 %U https://doi.org/10.2196/25208 %U http://www.ncbi.nlm.nih.gov/pubmed/33783363 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 1 %P e26621 %T Diabetes Engagement and Activation Platform for Implementation and Effectiveness of Automated Virtual Type 2 Diabetes Self-Management Education: Randomized Controlled Trial %A Sabo,Roy %A Robins,Jo %A Lutz,Stacy %A Kashiri,Paulette %A Day,Teresa %A Webel,Benjamin %A Krist,Alex %+ Virginia Commonwealth University, 830 East Main Street, Richmond, VA, United States, 1 804 828 3047, roy.sabo@vcuhealth.org %K type 2 diabetes mellitus %K self-management education %K patient engagement %K informatics %D 2021 %7 29.3.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Patients with type 2 diabetes require recommendations for self-management education and support. Objective: In this study, we aim to design the Diabetes Engagement and Activation Platform (DEAP)—an automated patient education tool integrated into primary care workflow—and examine its implementation and effectiveness. Methods: We invited patients aged 18-85 years with a hemoglobin A1c (HbA1c) level ≥8 to participate in a randomized controlled trial comparing DEAP with usual care. DEAP modules addressing type 2 diabetes self-management education and support domains were programmed into patient portals, each with self-guided educational readings, videos, and questions. Care teams received patient summaries and were alerted to patients with low confidence or requesting additional help. HbA1c, BMI, and systolic and diastolic blood pressure (DBP) were measured. Results: Out of the 680 patients invited to participate, 337 (49.5%) agreed and were randomized. All of the 189 intervention patients accessed the first module, and 140 patients (74.1%) accessed all 9 modules. Postmodule knowledge and confidence scores were high. Only 18 patients requested additional help from the care team. BMI was lower for intervention patients than controls at 3 months (31.7 kg/m2 vs 32.1 kg/m2; P=.04) and 6 months (32.5 kg/m2 vs 33.0 kg/m2; P=.003); improvements were even greater for intervention patients completing at least one module. There were no differences in 3- or 6-month HbA1c or blood pressure levels in the intent-to-treat analysis. However, intervention patients completing at least one module compared with controls had a better HbA1c level (7.6% vs 8.2%; P=.03) and DBP (72.3 mm Hg vs 75.9 mm Hg; P=.01) at 3 months. Conclusions: The findings of this study concluded that a significant proportion of patients will participate in an automated virtual diabetes self-management program embedded into patient portals and health systems show promise in helping patients manage their diabetes, weight, and blood pressure. Trial Registration: ClinicalTrials.gov NCT02957721; https://clinicaltrials.gov/ct2/show/NCT02957721 %M 33779567 %R 10.2196/26621 %U https://diabetes.jmir.org/2021/1/e26621 %U https://doi.org/10.2196/26621 %U http://www.ncbi.nlm.nih.gov/pubmed/33779567 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e25933 %T Voice-Based Conversational Agents for the Prevention and Management of Chronic and Mental Health Conditions: Systematic Literature Review %A Bérubé,Caterina %A Schachner,Theresa %A Keller,Roman %A Fleisch,Elgar %A v Wangenheim,Florian %A Barata,Filipe %A Kowatsch,Tobias %+ Center for Digital Health Interventions, Department of Management, Technology, and Economics, ETH Zurich, WEV G 214, Weinbergstrasse 56/58, Zurich, 8092, Switzerland, 41 44 633 8419, berubec@ethz.ch %K voice %K speech %K delivery of health care %K noncommunicable diseases %K conversational agents %K mobile phone %K smart speaker %K monitoring %K support %K chronic disease %K mental health %K systematic literature review %D 2021 %7 29.3.2021 %9 Review %J J Med Internet Res %G English %X Background: Chronic and mental health conditions are increasingly prevalent worldwide. As devices in our everyday lives offer more and more voice-based self-service, voice-based conversational agents (VCAs) have the potential to support the prevention and management of these conditions in a scalable manner. However, evidence on VCAs dedicated to the prevention and management of chronic and mental health conditions is unclear. Objective: This study provides a better understanding of the current methods used in the evaluation of health interventions for the prevention and management of chronic and mental health conditions delivered through VCAs. Methods: We conducted a systematic literature review using PubMed MEDLINE, Embase, PsycINFO, Scopus, and Web of Science databases. We included primary research involving the prevention or management of chronic or mental health conditions through a VCA and reporting an empirical evaluation of the system either in terms of system accuracy, technology acceptance, or both. A total of 2 independent reviewers conducted the screening and data extraction, and agreement between them was measured using Cohen kappa. A narrative approach was used to synthesize the selected records. Results: Of 7170 prescreened papers, 12 met the inclusion criteria. All studies were nonexperimental. The VCAs provided behavioral support (n=5), health monitoring services (n=3), or both (n=4). The interventions were delivered via smartphones (n=5), tablets (n=2), or smart speakers (n=3). In 2 cases, no device was specified. A total of 3 VCAs targeted cancer, whereas 2 VCAs targeted diabetes and heart failure. The other VCAs targeted hearing impairment, asthma, Parkinson disease, dementia, autism, intellectual disability, and depression. The majority of the studies (n=7) assessed technology acceptance, but only few studies (n=3) used validated instruments. Half of the studies (n=6) reported either performance measures on speech recognition or on the ability of VCAs to respond to health-related queries. Only a minority of the studies (n=2) reported behavioral measures or a measure of attitudes toward intervention-targeted health behavior. Moreover, only a minority of studies (n=4) reported controlling for participants’ previous experience with technology. Finally, risk bias varied markedly. Conclusions: The heterogeneity in the methods, the limited number of studies identified, and the high risk of bias show that research on VCAs for chronic and mental health conditions is still in its infancy. Although the results of system accuracy and technology acceptance are encouraging, there is still a need to establish more conclusive evidence on the efficacy of VCAs for the prevention and management of chronic and mental health conditions, both in absolute terms and in comparison with standard health care. %M 33658174 %R 10.2196/25933 %U https://www.jmir.org/2021/3/e25933 %U https://doi.org/10.2196/25933 %U http://www.ncbi.nlm.nih.gov/pubmed/33658174 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 8 %N 1 %P e20721 %T Applying Website Rankings to Digital Health Centers in the United States to Assess Public Engagement: Website Usability Study %A Calvano,Joshua David %A Fundingsland Jr,Edwin Lauritz %A Lai,Deborah %A Silacci,Sara %A Raja,Ali S %A He,Shuhan %+ Department of Research, Rocky Vista University College of Osteopathic Medicine, 8401 S Chambers Rd, Parker, CO, 80134, United States, 1 3033732008, joshua.calvano@rvu.edu %K website usability %K digital health %K health care website %K usability testing %K web interventions %K digital health care %K web crawler %D 2021 %7 29.3.2021 %9 Original Paper %J JMIR Hum Factors %G English %X Background: As the public increasingly uses the internet to search for resources and information regarding health and medicine, it is important that health care organizations provide adequate web resources. Website usability refers to the ease of user experience on a website. In this study, we conducted usability analyses on digital health center websites. Objective: The primary aims of this study were to (1) replicate a preexisting usability scoring methodology for digital health centers; (2) apply and test this replicated usability scoring methodology on a sample set of digital health center websites; and (3) derive recommendations from the results on potential areas of improvements for our sample of digital health center websites. Methods: Website usability testing was conducted from March 1, 2020, to March 15, 2020. We replicated a methodology and scoring system from previous literature and applied them to digital health center websites. Our sample included 67 digital health centers that were affiliated with US universities or hospital systems. Usability was split into the following four broad categories: accessibility, marketing, content quality, and technology. Usability tools were used to score websites in each of the four categories. The composite of the key factors of each category was used to generate a general usability and overall usability score for each website. Results: The category with the highest average score (6.3) was content quality. The content quality score also had the highest SD (2.18) and an SE of 0.27. The lowest performing category was technology, which had an average score of 0.9. The technology score also had the smallest SD (0.07) and an SE of 0.01. Conclusions: Our data suggest that content quality, on average, was the highest scoring variable among digital health center websites. As content is crucial to digital health knowledge, it is justified that digital health centers invest more resources into creating quality content. The overall lowest scoring variable was technology. Potential reasons for this finding include designated funding for servers, a lack of regulatory frameworks for social media presence and liability, and infrequent website audits. An easy approach for improving this variable is increasing website speed. Accessibility is another area that organizations can potentially improve. We recommend that these organizations perform periodic audits of their web presence with usability tools. %M 33779564 %R 10.2196/20721 %U https://humanfactors.jmir.org/2021/1/e20721 %U https://doi.org/10.2196/20721 %U http://www.ncbi.nlm.nih.gov/pubmed/33779564 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e25786 %T A Smartphone-Delivered Ecological Momentary Intervention for Problem Gambling (GamblingLess: Curb Your Urge): Single-Arm Acceptability and Feasibility Trial %A Hawker,Chloe O %A Merkouris,Stephanie S %A Youssef,George J %A Dowling,Nicki A %+ Deakin University, 1 Gheringhap St, Geelong, 3220, Australia, 61 03 9244 5610, chawker@deakin.edu.au %K gambling %K craving %K urge %K self-efficacy %K relapse %K smartphone %K self-help %K treatment %K ecological momentary assessment %K ecological momentary intervention %K mobile phone %D 2021 %7 26.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Low uptake rates of traditional gambling treatments highlight the need for innovative treatment modalities. Smartphone apps can provide unprecedented access to real-time ecological momentary interventions (EMIs) delivered in people’s everyday lives. Objective: This study aims to examine the acceptability, feasibility, and preliminary effectiveness of GamblingLess: Curb Your Urge, the first smartphone app–delivered EMI that aims to prevent gambling episodes by reducing craving intensity in people seeking help for gambling problems. Methods: This study was a single-arm, 5-week acceptability and feasibility trial (1-week baseline and 4-week intervention periods) involving ecological momentary assessments (EMAs) delivered 3 times daily. The EMAs measured gambling episodes, cravings, and self-efficacy. Web-based evaluations at baseline, postintervention, and 1-month follow-up measured gambling outcomes (severity, cravings, frequency, expenditure, and self-efficacy) and the intervention’s perceived helpfulness, relevance, burden, satisfaction, and impact in relation to gambling cravings. Results: A total of 36 participants, of whom 22/36 (61%) were male and 34/36 (94%) were problem gamblers, completed the baseline measures, with 61% (22/36) completing the postintervention evaluation and 58% (21/36) completing the follow-up evaluation. The intervention was considered acceptable, as participants perceived all intervention content to be above average in helpfulness and the EMA to be highly relevant but somewhat burdensome. Participants reported that they were satisfied with the intervention and that the intervention improved their knowledge, attitudes, awareness, behavior change, intention to change, and help-seeking behavior for gambling cravings. Regarding the intervention’s feasibility, compliance rates for the EMA (51%) and EMI (15%) were low; however, the intervention was used 166 times, including 59 uses within 60 minutes of EMA completion and 107 on-demand uses. Regarding the intervention’s preliminary effectiveness, descriptive EMA data showed that, compared with the baseline period, 71% and 72% reductions in the average number of gambling episodes and craving occurrences were reported in the intervention period, respectively. In addition, clustered paired-sample two-tailed t tests revealed a significant 5.4% reduction in real-time craving intensity (P=.01) immediately after intervention use, which increased to 10.5% (P=.01), where use was recommended based on craving occurrence. At the group level, significant medium-to-large reductions were observed in mean gambling symptom severity (P=.01 and .003), cravings (P=.03 and .02), frequency (P=.01 and .004), and expenditure (P=.04 and .003) at postintervention and follow-up; moreover, increased mean gambling self-efficacy and craving self-efficacy (P=.01 and .01) were observed at postintervention and increased gambling self-efficacy (P=.04) was observed at follow-up. At the individual level, over a quarter of participants (6/22, 27% to 10/21, 48%) could be categorized as recovered or improved regarding their gambling symptom severity and cravings. Conclusions: The results support the acceptability, feasibility, and preliminary effectiveness of this app-delivered EMI for preventing gambling episodes through craving management in people with gambling problems, which has implications for extending the reach of evidence-based treatment to moments of vulnerability in people’s everyday lives. %M 33769294 %R 10.2196/25786 %U https://www.jmir.org/2021/3/e25786 %U https://doi.org/10.2196/25786 %U http://www.ncbi.nlm.nih.gov/pubmed/33769294 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e25031 %T Mobile HIV Testing Through Social Networking Platforms: Comparative Study %A Chiou,Piao-Yi %A Ko,Nai-Ying %A Chien,Chien-Yu %+ School of Nursing, College of Medicine, National Taiwan University, No 2-1, Xuzhou Road, Zhongzheng District, Taipei City, 100, Taiwan, 886 2 23123456 ext 88427, purechiou2@gmail.com %K HIV testing %K internet-based intervention %K men who have sex with men %K mobile apps %K mobile phone %K risk-taking %K social networking %K voluntary counseling and testing %D 2021 %7 26.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Improving HIV screening in key populations is a crucial strategy to achieve the goal of eliminating AIDS in 2030. Social networking platforms can be used to recruit high risk-taking men who have sex with men (MSM) to promote the delivery of voluntary counseling and testing (VCT) as mobile HIV testing. Therefore, client recruitment and availability of mobile HIV testing through social networking platforms requires further evaluation. Objective: The aim of this study is to compare the effects of targeting high risk-taking MSM and HIV case finding between two mobile HIV testing recruitment approaches: through the traditional website-based approach and through social networking platforms. Methods: A comparative study design and propensity score matching was applied. The traditional VCT model, that is, the control group, recruited MSM through a website, and a trained research assistant visited the walk-in testing station at a gay village on Friday and Saturday nights. The social networking VCT model, the experimental group, recruited MSM from social networking platforms by periodically reloading into and conducting web-based discussions on dating apps and Facebook. The participants then referred to others in their social networks via a popular messenger app in Taiwan. The test was conducted at a designated time and place during weekdays by a trained research assistant. Across both modes of contact, before the mobile HIV testing, participants needed to provide demographic characteristics and respond to a questionnaire about HIV risk-taking behaviors. Results: We recruited 831 MSM over 6 months, with a completion rate of 8.56% (616/7200) in the traditional VCT model and 20.71% (215/1038) in the social networking VCT model. After propensity score matching, there were 215 MSM in each group (mean age 29.97, SD 7.61 years). The social networking model was more likely to reach MSM with HIV risk-taking behaviors, that is, those seeking sexual activity through social media, having multiple sexual partners and unprotected anal intercourse, having experience of recreational drug use, and never having or not regularly having an HIV test, compared with the traditional model. HIV positive rates (incidence rate ratio 3.40, 95% CI 1.089-10.584; P=.03) and clinic referral rates (incidence rate ratio 0.03, 95% CI 0.001-0.585; P=.006) were significantly higher among those in the social networking VCT model than in the traditional VCT model. Conclusions: Through effective recruitment strategies on social networking platforms, the social networking VCT mode can be smoothly promoted, as compared with the traditional VCT model, to target high risk-taking MSM and increase testing outcomes. %M 33769298 %R 10.2196/25031 %U https://www.jmir.org/2021/3/e25031 %U https://doi.org/10.2196/25031 %U http://www.ncbi.nlm.nih.gov/pubmed/33769298 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e24366 %T Blended Acceptance and Commitment Therapy Versus Face-to-face Cognitive Behavioral Therapy for Older Adults With Anxiety Symptoms in Primary Care: Pragmatic Single-blind Cluster Randomized Trial %A Witlox,Maartje %A Garnefski,Nadia %A Kraaij,Vivian %A de Waal,Margot W M %A Smit,Filip %A Bohlmeijer,Ernst %A Spinhoven,Philip %+ Faculty of Social and Behavioural Sciences, Section of Clinical Psychology, Institute of Psychology, Leiden University, Wassenaarseweg 52, Leiden, 2333 AK, Netherlands, 31 0611858085, m.witlox@fsw.leidenuniv.nl %K acceptance and commitment therapy %K anxiety %K older adults %K internet interventions %K cognitive behavioral therapy %D 2021 %7 26.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Anxiety symptoms in older adults are prevalent and disabling but often go untreated. Most trials on psychological interventions for anxiety in later life have examined the effectiveness of face-to-face cognitive behavioral therapy (CBT). To bridge the current treatment gap, other treatment approaches and delivery formats should also be evaluated. Objective: This study is the first to examine the effectiveness of a brief blended acceptance and commitment therapy (ACT) intervention for older adults with anxiety symptoms, compared with a face-to-face CBT intervention. Methods: Adults aged between 55-75 years (n=314) with mild to moderately severe anxiety symptoms were recruited from general practices and cluster randomized to either blended ACT or face-to-face CBT. Assessments were performed at baseline (T0), posttreatment (T1), and at 6- and 12-month follow-ups (T2 and T3, respectively). The primary outcome was anxiety symptom severity (Generalized Anxiety Disorder-7). Secondary outcomes were positive mental health, depression symptom severity, functional impairment, presence of Diagnostic and Statistical Manual of Mental Disorders V anxiety disorders, and treatment satisfaction. Results: Conditions did not differ significantly regarding changes in anxiety symptom severity during the study period (T0-T1: B=.18, P=.73; T1-T2: B=−.63, P=.26; T1-T3: B=−.33, P=.59). Large reductions in anxiety symptom severity (Cohen d≥0.96) were found in both conditions post treatment, and these were maintained at the 12-month follow-up. The rates of clinically significant changes in anxiety symptoms were also not different for the blended ACT group and CBT group (χ21=0.2, P=.68). Regarding secondary outcomes, long-term effects on positive mental health were significantly stronger in the blended ACT group (B=.27, P=.03, Cohen d=0.29), and treatment satisfaction was significantly higher for blended ACT than CBT (B=3.19, P<.001, Cohen d=0.78). No other differences between the conditions were observed in the secondary outcomes. Conclusions: The results show that blended ACT is a valuable treatment alternative to CBT for anxiety in later life. Trial Registration: Netherlands Trial Register TRIAL NL6131 (NTR6270); https://www.trialregister.nl/trial/6131 %M 33769293 %R 10.2196/24366 %U https://www.jmir.org/2021/3/e24366 %U https://doi.org/10.2196/24366 %U http://www.ncbi.nlm.nih.gov/pubmed/33769293 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e18517 %T Attitudes and Engagement of Pregnant and Postnatal Women With a Web-Based Emotional Health Tool (Mummatters): Cross-sectional Study %A Reilly,Nicole %A Austin,Marie-Paule %+ Centre for Health Service Development, Australian Health Services Research Institute, University of Wollongong, Building 234 (iC Enterprise 1), Innovation Campus, Wollongong, 2522, Australia, 61 0242218045, nreilly@uow.edu.au %K pregnancy %K postpartum %K self-assessment %K depression %K risk %D 2021 %7 26.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Mummatters is a web-based health tool that allows women to self-assess the symptoms of depression and the presence of psychosocial risk factors throughout pregnancy and the postnatal period. It aims to increase women’s awareness of their own symptoms or risk factors and their knowledge of the available support options, to encourage engagement with these support options (as appropriate), and to facilitate communication about emotional health issues between women and their health care providers. Objective: The aim of this study is to report the uptake of mummatters; the sociodemographic and psychosocial risk profiles of a subsample of users; and the acceptability, credibility, perceived effect, and motivational appeal of the tool. The help-seeking behaviors of the subsample of users and barriers to help seeking were also examined. Methods: Mummatters was launched in November 2016. Women who completed the mummatters baseline assessment were invited to complete a web-based follow-up survey 1 month later. Results: A total of 2817 women downloaded and used mummatters between November 13, 2016, and May 22, 2018, and 140 women participated in the follow-up study. Approximately half of these women (51%; 72/140) were Whooley positive (possible depression), and 43% (60/140) had an elevated psychosocial risk score on the Antenatal Risk Questionnaire. Mummatters was rated favorably by pregnant and postnatal women in terms of its acceptability (94%-99%), credibility (93%-97%), appeal (78%-91%), and potential to affect a range of health behaviors specific to supporting emotional wellness during the perinatal period (78%-93%). Whooley-positive women were more likely to speak with their families than with a health care provider about their emotional health. Normalizing symptoms and stigma were key barriers to seeking help. Conclusions: Although mummatters was rated positively by consumers, only 53% (19/36) to 61% (22/36) of women with possible depression reported speaking to their health care providers about their emotional health. There was a trend for more prominent barriers to seeking help among postnatal women than among pregnant women. Future studies that investigate whether social barriers to seeking help are greater once a woman has an infant are warranted. Such barriers potentially place these women at greater risk of remaining untreated, as the demands on them are greater. %M 33769302 %R 10.2196/18517 %U https://www.jmir.org/2021/3/e18517 %U https://doi.org/10.2196/18517 %U http://www.ncbi.nlm.nih.gov/pubmed/33769302 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e17908 %T Evaluating Glycemic Control in Patients of South Asian Origin With Type 2 Diabetes Using a Digital Therapeutic Platform: Analysis of Real-World Data %A Krishnakumar,Arjun %A Verma,Ritika %A Chawla,Rajeev %A Sosale,Aravind %A Saboo,Banshi %A Joshi,Shilpa %A Shaikh,Maaz %A Shah,Abhishek %A Kolwankar,Siddhesh %A Mattoo,Vinod %+ Wellthy Therapeutics Pvt Ltd, 20, Nagin Mahal, 5th Floor, 82, Veer Nariman Road, Churchgate, Mumbai, 400020, India, 91 9833962132, sid.kolwankar@wellthy.care %K digital therapeutics %K type 2 diabetes %K behavior change %K diabetes self-management %K lifestyle intervention %K mobile phone %D 2021 %7 25.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital therapeutics are evidence-based therapeutic interventions driven by high-quality software programs for the treatment, prevention, or management of a medical disorder or disease. Many studies in the western population have shown the effectiveness of mobile app–based digital therapeutics for improving glycemic control in patients with type 2 diabetes (T2D). However, few studies have assessed similar outcomes in the South Asian population. Objective: This study aims to investigate the real-world effectiveness of the Wellthy CARE digital therapeutic for improving glycemic control among the South Asian population of Indian origin. Methods: We analyzed deidentified data from 102 patients with T2D from India enrolled in a 16-week structured self-management program delivered using the Wellthy CARE mobile app. Patients recorded their meals, weight, physical activity, and blood sugar in the app, and they received lessons on self-care behaviors (healthy eating, being active, monitoring, medication adherence, problem solving, healthy coping, and reducing risks); feedback provided by an artificial intelligence–powered chatbot; and periodic interactions with certified diabetes educators via voice calls and chats. The primary outcome of the program was a change in glycated hemoglobin A1c (HbA1c). Secondary outcomes included the difference between preintervention and postintervention fasting blood glucose (FBG) and postprandial blood glucose (PPBG) levels; changes in BMI and weight at the completion of 16 weeks; and the association between program engagement and the changes in HbA1c, FBG, and PPBG levels. Results: At the end of 16 weeks, the average change in HbA1c was –0.49% (n=102; 95% CI −0.73 to 0.25; P<.001). Of all the patients, 63.7% (65/102) had improved HbA1c levels, with a mean change of −1.16% (n=65; 95% CI −1.40 to −0.92; P<.001). The mean preintervention and postintervention FBG levels were 145 mg/dL (n=51; 95% CI 135-155) and 134 mg/dL (n=51; 95% CI 122-146; P=.02) and PPBG levels were 188 mg/dL (n=51; 95% CI 172-203) and 166 mg/dL (n=51; 95% CI 153-180; P=.03), respectively. The mean changes in BMI and weight were –0.47 kg/m2 (n=59; 95% CI −0.22 to −0.71; P<.001) and –1.32 kg (n=59; 95% CI −0.63 to −2.01; P<.001), respectively. There was a stepwise decrease in HbA1c, FBG, and PPBG levels as the program engagement increased. Patients in the highest tertile of program engagement had a significantly higher reduction in HbA1c (−0.84% vs −0.06%; P=.02), FBG (−21.4 mg/dL vs −0.18 mg/dL; P=.02), and PPBG levels (−22.03 mg/dL vs 2.35 mg/dL; P=.002) than those in the lowest tertile. Conclusions: The use of the Wellthy CARE digital therapeutic for patients with T2D showed a significant reduction in the levels of HbA1c, FBG, and PPBG after 16 weeks. A higher level of participation showed improved glycemic control, suggesting the potential of the Wellthy CARE platform for better management of the disease. %M 33764306 %R 10.2196/17908 %U https://www.jmir.org/2021/3/e17908 %U https://doi.org/10.2196/17908 %U http://www.ncbi.nlm.nih.gov/pubmed/33764306 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e24387 %T Barriers to and Facilitators of User Engagement With Digital Mental Health Interventions: Systematic Review %A Borghouts,Judith %A Eikey,Elizabeth %A Mark,Gloria %A De Leon,Cinthia %A Schueller,Stephen M %A Schneider,Margaret %A Stadnick,Nicole %A Zheng,Kai %A Mukamel,Dana %A Sorkin,Dara H %+ University of California Irvine, 6210 Donald Bren Hall, Irvine, CA, 92697-3425, United States, 1 9498240246, jborghou@uci.edu %K mHealth %K eHealth %K mental health %K depression %K anxiety %K behavior %K mobile phone %D 2021 %7 24.3.2021 %9 Review %J J Med Internet Res %G English %X Background: Digital mental health interventions (DMHIs), which deliver mental health support via technologies such as mobile apps, can increase access to mental health support, and many studies have demonstrated their effectiveness in improving symptoms. However, user engagement varies, with regard to a user’s uptake and sustained interactions with these interventions. Objective: This systematic review aims to identify common barriers and facilitators that influence user engagement with DMHIs. Methods: A systematic search was conducted in the SCOPUS, PubMed, PsycINFO, Web of Science, and Cochrane Library databases. Empirical studies that report qualitative and/or quantitative data were included. Results: A total of 208 articles met the inclusion criteria. The included articles used a variety of methodologies, including interviews, surveys, focus groups, workshops, field studies, and analysis of user reviews. Factors extracted for coding were related to the end user, the program or content offered by the intervention, and the technology and implementation environment. Common barriers included severe mental health issues that hampered engagement, technical issues, and a lack of personalization. Common facilitators were social connectedness facilitated by the intervention, increased insight into health, and a feeling of being in control of one’s own health. Conclusions: Although previous research suggests that DMHIs can be useful in supporting mental health, contextual factors are important determinants of whether users actually engage with these interventions. The factors identified in this review can provide guidance when evaluating DMHIs to help explain and understand user engagement and can inform the design and development of new digital interventions. %M 33759801 %R 10.2196/24387 %U https://www.jmir.org/2021/3/e24387 %U https://doi.org/10.2196/24387 %U http://www.ncbi.nlm.nih.gov/pubmed/33759801 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e23137 %T Key Variables for Effective eHealth Designs for Individuals With and Without Mental Health Disorders: 2^12-4 Fractional Factorial Experiment %A Rotondi,Armando J %A Grady,Jonathan %A Hanusa,Barbara H %A Haas,Gretchen L %A Spring,Michael R %A Abebe,Kaleab Z %A Luther,James %A Gurklis,John %+ Mental Illness Research, Education and Clinical Center (MIRECC), VA Pittsburgh Health Care System, Department of Veterans Affairs, Research Office Bld, (151R-U), University Drive C, Pittsburgh, PA, 15240, United States, 1 412 360 2369, armandorotondi1@gmail.com %K schizophrenia %K severe mental illness %K eHealth %K eHealth design %K website %K usability %K website design %K website usability %K fractional factorial design %D 2021 %7 24.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: eHealth applications not only offer the potential to increase service convenience and responsiveness but also expand the ability to tailor services to improve relevance, engagement, and use. To achieve these goals, it is critical that the designs are intuitive. Limited research exists on designs that work for those with a severe mental illness (SMI), many of whom have difficulty traveling for treatments, reject or infrequently seek treatment, and tend to discontinue treatments for significant periods. Objective: This study aims to evaluate the influence of 12 design variables (eg, navigational depth, reading level, and use of navigational lists) on the usability of eHealth application websites for those with and without SMI. Methods: A 212-4 fractional factorial experiment was used to specify the designs of 256 eHealth websites. This approach systematically varied the 12 design variables. The final destination contents of all websites were identical, and only the designs of the navigational pages varied. The 12 design elements were manipulated systematically to allow the assessment of combinations of design elements rather than only one element at a time. Of the 256 websites, participants (n=222) sought the same information on 8 randomly selected websites. Mixed effect regressions, which accounted for the dependency of the 8 observations within participants, were used to test for main effects and interactions on the ability and time to find information. Classification and regression tree analyses were used to identify effects among the 12 variables on participants’ abilities to locate information, for the sample overall and each of the 3 diagnostic groups of participants (schizophrenia spectrum disorder [SSD], other mental illnesses, and no mental illness). Results: The best and worst designs were identified for each of these 4 groups. The depth of a website’s navigation, that is, the number of screens users needed to navigate to find the desired content, had the greatest influence on usability (ability to find information) and efficiency (time to find information). The worst performing designs for those with SSD had a 9% success rate, and the best had a 51% success rate: the navigational designs made a 42% difference in usability. For the group with other mental illnesses, the design made a 50% difference, and for those with no mental illness, a 55% difference was observed. The designs with the highest usability had several key design similarities, as did those with the poorest usability. Conclusions: It is possible to identify evidence-based strategies for designing eHealth applications that result in significantly better performance. These improvements in design benefit all users. For those with SSD or other SMIs, there are designs that are highly effective. Both the best and worst designs have key similarities but vary in some characteristics. %M 33759796 %R 10.2196/23137 %U https://www.jmir.org/2021/3/e23137 %U https://doi.org/10.2196/23137 %U http://www.ncbi.nlm.nih.gov/pubmed/33759796 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e23533 %T Human Coaching Methodologies for Automatic Electronic Coaching (eCoaching) as Behavioral Interventions With Information and Communication Technology: Systematic Review %A Chatterjee,Ayan %A Gerdes,Martin %A Prinz,Andreas %A Martinez,Santiago %+ Department for Information and Communication Technologies, Centre for e-Health, University of Agder, Jon Lilletuns Vei 9, Grimstad, 4879, Norway, 47 38141000, ayan.chatterjee@uia.no %K coaching %K electronic coaching %K human behavior %K healthy lifestyle %K persuasive technology %D 2021 %7 24.3.2021 %9 Review %J J Med Internet Res %G English %X Background: We systematically reviewed the literature on human coaching to identify different coaching processes as behavioral interventions and methods within those processes. We then reviewed how those identified coaching processes and the used methods can be utilized to improve an electronic coaching (eCoaching) process for the promotion of a healthy lifestyle with the support of information and communication technology (ICT). Objective: This study aimed to identify coaching and eCoaching processes as behavioral interventions and the methods behind these processes. Here, we mainly looked at processes (and corresponding models that describe coaching as certain processes) and the methods that were used within the different processes. Several methods will be part of multiple processes. Certain processes (or the corresponding models) will be applicable for both human coaching and eCoaching. Methods: We performed a systematic literature review to search the scientific databases EBSCOhost, Scopus, ACM, Nature, SpringerLink, IEEE Xplore, MDPI, Google Scholar, and PubMed for publications that included personal coaching (from 2000 to 2019) and persuasive eCoaching as behavioral interventions for a healthy lifestyle (from 2014 to 2019). The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) framework was used for the evidence-based systematic review and meta-analysis. Results: The systematic search resulted in 79 publications, including 72 papers and seven books. Of these, 53 were related to behavioral interventions by eCoaching and the remaining 26 were related to human coaching. The most utilized persuasive eCoaching methods were personalization (n=19), interaction and cocreation (n=17), technology adoption for behavior change (n= 17), goal setting and evaluation (n=16), persuasion (n=15), automation (n=14), and lifestyle change (n=14). The most relevant methods for human coaching were behavior (n=23), methodology (n=10), psychology (n=9), and mentoring (n=6). Here, “n” signifies the total number of articles where the respective method was identified. In this study, we focused on different coaching methods to understand the psychology, behavioral science, coaching philosophy, and essential coaching processes for effective coaching. We have discussed how we can integrate the obtained knowledge into the eCoaching process for healthy lifestyle management using ICT. We identified that knowledge, coaching skills, observation, interaction, ethics, trust, efficacy study, coaching experience, pragmatism, intervention, goal setting, and evaluation of coaching processes are relevant for eCoaching. Conclusions: This systematic literature review selected processes, associated methods, strengths, and limitations for behavioral interventions from established coaching models. The identified methods of coaching point toward integrating human psychology in eCoaching to develop effective intervention plans for healthy lifestyle management and overcome the existing limitations of human coaching. %M 33759793 %R 10.2196/23533 %U https://www.jmir.org/2021/3/e23533 %U https://doi.org/10.2196/23533 %U http://www.ncbi.nlm.nih.gov/pubmed/33759793 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 4 %N 1 %P e23193 %T A Theory of Change for Web-Based Therapy and Support Services for Children and Young People: Collaborative Qualitative Exploration %A Hanley,Terry %A Sefi,Aaron %A Grauberg,Janet %A Prescott,Julie %A Etchebarne,Andre %+ University of Manchester, Oxford Road, Manchester, M13 9PL, United Kingdom, 44 1612758815, terry.hanley@manchester.ac.uk %K telepsychology %K digital mental health %K online therapy %K young people %K Kooth %K Theory of Change %K positive virtual ecosystems %D 2021 %7 22.3.2021 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Web-based counseling and support has become increasingly commonplace for children and young people (CYP). Currently, there is limited research that focuses on the mechanisms of change within complex telepsychology platforms, a factor that makes designing and implementing outcome measures challenging. Objective: This project aims to articulate a theory of change (ToC) for Kooth, a web-based therapy and support platform for CYP. Methods: A collaborative qualitative research design involving professional staff, academic partners, and young people was used to develop the ToC. The following three major reflective phases were engaged: a scoping workshop involving professional staff and academic partners, a series of explorative projects were completed to inform the development of the ToC, and the draft ToC was reviewed for coherence by key stakeholders (young people, online professionals, and service managers). Results: A collaboratively developed ToC was presented. This was divided into the conditions that lead to individuals wanting to access web-based therapy and support (eg, individuals wanting support there and then or quickly), the mode of service delivery (eg, skilled and experienced professionals able to build empathetic relationships with CYP), and the observed and reported changes that occur as a consequence of using the service (eg, individuals being better able to manage current and future situations). Conclusions: Developing the ToC helps to shed light on how web-based therapy and support services aid the mental health and well-being of CYP. Furthermore, it helps to understand the development of positive virtual ecosystems and can be used to devise evaluative tools for CYP telepsychology providers. %M 33749615 %R 10.2196/23193 %U https://pediatrics.jmir.org/2021/1/e23193 %U https://doi.org/10.2196/23193 %U http://www.ncbi.nlm.nih.gov/pubmed/33749615 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e22548 %T In-Clinic Versus Web-Based Multidisciplinary Exercise-Based Rehabilitation for Treatment of Low Back Pain: Prospective Clinical Trial in an Integrated Practice Unit Model %A Raiszadeh,Kamshad %A Tapicer,Jonathan %A Taitano,Lissa %A Wu,Jonathan %A Shahidi,Bahar %+ Department of Orthopaedic Surgery, University of California San Diego, 9500 Gilman Dr, MC0863, San Diego, CA, United States, 1 858 822 0439, bshahidi@health.ucsd.edu %K low back pain %K telehealth %K online therapy %K physical therapy %K integrated practice unit %K rehabilitation %D 2021 %7 18.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The recent onset of the COVID-19 pandemic has highlighted the need to reduce barriers to access physical therapy and associated care through the use of web-based programs and telehealth for those seeking treatment for low back pain (LBP). Despite this need, few studies have compared the effectiveness of clinic-based versus web-based or telehealth services. Objective: This study aims to compare the clinical outcomes of clinic-based multidisciplinary therapy in an integrated practice unit (C-IPU) model with online integrated multidisciplinary therapy (O-IPU) in individuals undergoing conservative care for LBP. Methods: A total of 1090 participants were prospectively recruited to participate in a clinical trial registry (NCT04081896) through the SpineZone rehabilitation IPU program. All participants provided informed consent. Participants were allocated to the C-IPU (N=988) or O-IPU (N=102) groups based on their personal preferences. The C-IPU program consisted of a high-intensity machine-based core muscle resistance training program, whereas the O-IPU program consisted of therapist-directed home core strengthening exercises through a web-based platform. Changes in LBP symptom severity (Numeric Pain Rating Scale), disability (Oswestry Disability Index), goal achievement (Patient-Specific Functional Scale), and frequency of opioid use were compared between the C-IPU and O-IPU groups using multivariate linear regression modeling adjusted for age, gender, treatment number, program duration, and baseline pain and disability. Results: Approximately 93.03% (1014/1090) of the participants completed their recommended programs, with no group differences in dropout rates (P=.78). The C-IPU group showed greater pain relief (P<.001) and reductions in disability (P=.002) than the O-IPU group, whereas the O-IPU group reported greater improvements in goal achievement (P<.001). Both programs resulted in reduced opioid use frequency, with 19.0% (188/988) and 21.5% (22/102) of participants reporting cessation of opioid use for C-IPU and O-IPU programs, respectively, leaving only 5.59% (61/1090) of participants reporting opioid use at the end of their treatment. Conclusions: Both in-clinic and web-based multidisciplinary programs are beneficial in reducing pain, disability, and opioid use and in improving goal achievement. The differences between these self-selected groups shed light on patient characteristics, which require further investigation and could help clinicians optimize these programs. Trial Registration: ClinicalTrials.gov NCT04081896; https://clinicaltrials.gov/ct2/show/NCT04081896 %M 33734088 %R 10.2196/22548 %U https://www.jmir.org/2021/3/e22548 %U https://doi.org/10.2196/22548 %U http://www.ncbi.nlm.nih.gov/pubmed/33734088 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 8 %N 1 %P e24343 %T Emotional Reactions and Likelihood of Response to Questions Designed for a Mental Health Chatbot Among Adolescents: Experimental Study %A Mariamo,Audrey %A Temcheff,Caroline Elizabeth %A Léger,Pierre-Majorique %A Senecal,Sylvain %A Lau,Marianne Alexandra %+ Department of Educational and Counselling Psychology, McGill University, 3700 McTavish St, Montreal, QC, H3A 1Y2, Canada, 1 5149697302, audrey.mariamo@mail.mcgill.ca %K chatbots %K conversational agents %K mental health %K well-being %K adolescents %K user experience %K user preferences %D 2021 %7 18.3.2021 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Psychological distress increases across adolescence and has been associated with several important health outcomes with consequences that can extend into adulthood. One type of technological innovation that may serve as a unique intervention for youth experiencing psychological distress is the conversational agent, otherwise known as a chatbot. Further research is needed on the factors that may make mental health chatbots destined for adolescents more appealing and increase the likelihood that adolescents will use them. Objective: The aim of this study was to assess adolescents’ emotional reactions and likelihood of responding to questions that could be posed by a mental health chatbot. Understanding adolescent preferences and factors that could increase adolescents’ likelihood of responding to chatbot questions could assist in future mental health chatbot design destined for youth. Methods: We recruited 19 adolescents aged 14 to 17 years to participate in a study with a 2×2×3 within-subjects factorial design. Each participant was sequentially presented with 96 chatbot questions for a duration of 8 seconds per question. Following each presentation, participants were asked to indicate how likely they were to respond to the question, as well as their perceived affective reaction to the question. Demographic data were collected, and an informal debriefing was conducted with each participant. Results: Participants were an average of 15.3 years old (SD 1.00) and mostly female (11/19, 58%). Logistic regressions showed that the presence of GIFs predicted perceived emotional valence (β=–.40, P<.001), such that questions without GIFs were associated with a negative perceived emotional valence. Question type predicted emotional valence, such that yes/no questions (β=–.23, P=.03) and open-ended questions (β=–.26, P=.01) were associated with a negative perceived emotional valence compared to multiple response choice questions. Question type also predicted the likelihood of response, such that yes/no questions were associated with a lower likelihood of response compared to multiple response choice questions (β=–.24, P=.03) and a higher likelihood of response compared to open-ended questions (β=.54, P<.001). Conclusions: The findings of this study add to the rapidly growing field of teen-computer interaction and contribute to our understanding of adolescent user experience in their interactions with a mental health chatbot. The insights gained from this study may be of assistance to developers and designers of mental health chatbots. %M 33734089 %R 10.2196/24343 %U https://humanfactors.jmir.org/2021/1/e24343 %U https://doi.org/10.2196/24343 %U http://www.ncbi.nlm.nih.gov/pubmed/33734089 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 8 %N 1 %P e19519 %T Using a Web-Based App to Deliver Rehabilitation Strategies to Persons With Chronic Conditions: Development and Usability Study %A Richardson,Julie %A Letts,Lori %A Sinclair,Susanne %A Chan,David %A Miller,Jordan %A Donnelly,Catherine %A Smith-Turchyn,Jenna %A Wojkowski,Sarah %A Gravesande,Janelle %A Loyola Sánchez,Adalberto %+ School of Rehabilitation Science, Faculty of Health Sciences, McMaster University, 1400 Main Street West, IAHS Room 403, Hamilton, ON, L8S 1C7, Canada, 1 905 525 9140 ext 27811, jrichard@mcmaster.ca %K rehabilitation %K physiotherapy %K occupational therapy %K self-management %K function %K web-based application %K usability %K user-centered design %D 2021 %7 18.3.2021 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: The global rise in the incidence of chronic conditions and aging is associated with increased disability. Physiotherapists and occupational therapists can mitigate the resulting burden on the health care system with their expertise in optimizing function. Rehabilitation self-management strategies can assist people with chronic conditions to accept, adjust, and manage different aspects of their daily functioning. Interventions delivered using technology have the potential to increase the accessibility, availability, and affordability of rehabilitation self-management support and services. Objective: This study aims to describe the development and usability evaluation of iamable, a web-based app created to provide rehabilitation self-management support for people with chronic conditions. Methods: The development and evaluation of iamable were undertaken in several phases. We used user-centered design principles and an iterative process that included consultations with rehabilitation experts; developed a prototype; and conducted usability tests, heuristic evaluations, and a focus group analysis. Results: The iamable app was developed to provide rehabilitation self-management strategies in the areas of exercise, fall prevention, fatigue management, pain management, physical activity, and stress management. We engaged adults aged ≥45 years with at least one chronic condition (N=11) in usability testing. They identified navigation and the understanding of instructions as the primary issues for end users. During the heuristic evaluation, clinicians (N=6) recommended that some areas of app content should be more succinct and that help should be more readily available. The focus group provided input to help guide clinical simulation testing, including strategies for selecting patients and overcoming barriers to implementation. Conclusions: We engaged end users and clinicians in the development and evaluation of the iamable app in an effort to create a web-based tool that was useful to therapists and their patients. By addressing usability issues, we were able to ensure that patients had access to rehabilitation strategies that could be used to help them better manage their health. Our app also provides therapists with a platform that they can trust to empower their patients to be more active in the management of chronic conditions. This paper provides a resource that can be used by others to develop and evaluate web-based health apps. %M 33734090 %R 10.2196/19519 %U https://rehab.jmir.org/2021/1/e19519 %U https://doi.org/10.2196/19519 %U http://www.ncbi.nlm.nih.gov/pubmed/33734090 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e24926 %T Developing a Web-Based Shared Decision-Making Tool for Fertility Preservation Among Reproductive-Age Women With Breast Cancer: An Action Research Approach %A Tseng,Ling-Ming %A Lien,Pei-Ju %A Huang,Chen-Yu %A Tsai,Yi-Fang %A Chao,Ta-Chung %A Huang,Sheng-Miauh %+ MacKay Medical College, Department of Nursing, No. 46, Section 3, Zhongzheng Road, Sanzhi District, New Taipei City, 252, Taiwan, 886 2 26360303 ext 1316, r910862@yahoo.com.tw %K breast cancer %K shared decision making %K website %K action research %K fertility preservation %D 2021 %7 17.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The pregnancy rate after cancer treatment for female survivors is lower than that of the general population. Future infertility is a significant concern for patients with breast cancer and is associated with a poor quality of life. Reproductive-age patients with breast cancer have safe options when choosing a type of fertility preservation method to be applied. Better information and support resources aimed at women to support their decision making are needed. Objective: The objective of this study was to develop a web-based shared decision-making tool for helping patients with breast cancer make decisions on fertility preservation. Methods: We used the action research cycle of observing, reflecting, planning, and acting to develop a web-based shared decision-making tool. The following four phrases were applied: (1) observe and reflect—collect and analyze the decision-making experiences of patients and health care providers; (2) reflect and plan—apply the initial results to create a paper design and modify the content; (3) plan and act—brainstorm about the web pages and modify the content; (4) act and observe—evaluate the effectiveness and refine the website’s shared decision-making tool. Interviews, group meetings, and constant dialogue were conducted between the various participants at each step. Effectiveness was evaluated using the Preparation for Decision-Making scale. Results: Five major parts were developed with the use of the action research approach. The Introduction (part 1) describes the severity of cancer treatment and infertility. Options (part 2) provides the knowledge of fertility preservation. The shared decision-making tool was designed as a step-by-step process (part 3) that involves the comparison of options, patient values, and preferences; their knowledge regarding infertility and options; and reaching a collective decision. Resources (part 4) provides information on the hospitals that provide such services, and References (part 5) lists all the literature cited in the website. The results show the web-based shared decision-making meets both patients’ and health providers’ needs and helps reproductive-age patients with breast cancer make decisions about fertility preservation. Conclusions: We have created the first web-based shared decision-making tool for making fertility preservation decisions in Taiwan. We believe female patients of reproductive age will find the tool useful and its use will become widespread, which should increase patient autonomy and improve communication about fertility preservation with clinicians. Trial Registration: Clinicaltrials.gov NCT04602910; https://clinicaltrials.gov/ct2/show/NCT04602910 %M 33729164 %R 10.2196/24926 %U https://www.jmir.org/2021/3/e24926 %U https://doi.org/10.2196/24926 %U http://www.ncbi.nlm.nih.gov/pubmed/33729164 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 3 %P e22147 %T A Smartphone App to Restore Optimal Weight (SPAROW) in Women With Recent Gestational Diabetes Mellitus: Randomized Controlled Trial %A Lim,Karen %A Chan,Shiao-Yng %A Lim,Su Lin %A Tai,Bee Choo %A Tsai,Cammy %A Wong,Su Ren %A Ang,Siew Min %A Yew,Tong Wei %A Tai,E Shyong %A Yong,Eu Leong %+ Department of Obstetrics and Gynecology, National University Hospital, Yong Loo Lin School of Medicine, National University of Singapore, 5 Lower Kent Ridge Rd, Singapore, 119074, Singapore, 65 81125777, obgyel@nus.edu.sg %K randomized controlled trial %K gestational diabetes mellitus %K prevention %K weight loss %K mobile phone %D 2021 %7 16.3.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Women with a history of gestational diabetes mellitus (GDM) are at an increased risk of developing type 2 diabetes mellitus (T2DM). Lifestyle interventions aimed at postpartum weight loss to reduce T2DM risk have been reported, but poor compliance remains a barrier. Smartphone-based interventions may improve compliance, but data on its use in women with recent GDM are limited. Objective: This trial aimed to investigate the efficacy of a smartphone app in restoring optimal weight following delivery in women with GDM, in the setting of a population with high rates of GDM and type 2 diabetes. Methods: In this unblinded randomized controlled trial, 200 women with GDM were randomized to receive the intervention or standard care following delivery. The intervention enabled logging of weight, meals, and activity, with web-based interaction with a team comprising dieticians, a physiotherapist, and an occupational therapist. The primary outcome was an achievement of optimal weight (defined as the restoration of first trimester weight if first trimester BMI≤23 kg/m2 or weight loss of at least 5% from first trimester weight if first trimester BMI>23 kg/m2) at 4 months post partum. Secondary outcome measures included absolute weight loss, serum metabolic markers, self-reported nutritional intake, health education, and quality of life via questionnaires and user engagement in the intervention group. Results: In total, 40% (38/96) of women in the intervention group achieved optimal weight at 4 months post delivery compared with 32% (28/93) in the control group (P=.27). Compared with the control group, women in the intervention group reported significantly reduced caloric intake at 4 months after delivery (P<.001) and higher health-directed behavior scores (P=.045). The intervention group also reported increased emotional distress scores (P=.01). At 4 months, participant engagement with the intervention was maintained at 60.8% (SD 33.9%). Conclusions: Although a statistically significant increase in women achieving healthy weight was not observed, this app remains promising, as women in the intervention group reported improved health behaviors and lower caloric intake. Importantly, the high retention rates suggest that a larger study with a longer follow-up period might confirm the effectiveness of this app for weight management. Trial Registration: ClinicalTrials.gov NCT03324737; https://clinicaltrials.gov/ct2/show/NCT03324737 International Registered Report Identifier (IRRID): RR2-10.1186/s12889-019-7691-3 %M 33724204 %R 10.2196/22147 %U https://mhealth.jmir.org/2021/3/e22147 %U https://doi.org/10.2196/22147 %U http://www.ncbi.nlm.nih.gov/pubmed/33724204 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e22465 %T Web-Based Dietary and Physical Activity Intervention Programs for Patients With Hypertension: Scoping Review %A Baderol Allam,Fatimah Najihah %A Ab Hamid,Mohd Ramadan %A Buhari,Siti Sabariah %A Md Noor,Harrinni %+ Centre for Dietetics Studies, Faculty of Health Sciences, Universiti Teknologi MARA, Puncak Alam, Malaysia, 60 332584424, ramadan7230@uitm.edu.my %K hypertension %K blood pressure %K education %K website-based %K dietary intake %K physical activity %D 2021 %7 15.3.2021 %9 Review %J J Med Internet Res %G English %X Background: Hypertension is the root cause of many chronic diseases. Lifestyle changes (ie, dietary alterations and physical activity) are seen to be an important step in the prevention and treatment of hypertension. Educating people through web-based interventional programs could offer an effective solution and help these patients with hypertension in the existing health care scenario. Objective: In this study, the researchers conducted a scoping literature review of the web-based dietary changes and physical activity–related intervention programs designed for the patients with hypertension and identified the methodologies, effectiveness, protocols, and theories, which could affect and improve existing clinical activities. Methods: This review followed the scoping review methodology to identify and process the peer-reviewed studies published between 2010 and 2020. The literature searches were conducted on the following electronic databases: PubMed, Web of Science, MEDLINE (Medical Literature Analysis and Retrieval System Online), ScienceDirect, Scopus, and Google Scholar. By using relevant search terms, studies were included if they offered information related to the web-based intervention tools, specifically dietary and physical activity intervention for patients with hypertension. Studies written or translated in English language and published within the date range (January 2010 to March 2020) were included. Results: Overall, 1441 articles were initially identified. The reviewers included 35 articles after removing duplicates and screening titles. Only 21 articles were assessed for full review, and 15 were kept for analysis. The researchers selected 15 web-based intervention articles published on the topic of hypertension from 7 countries. A few of these 15 web-based tools (4, 27%) included more than 3 functions and provided a lot of important information (such as appointments, health records, or viewable care). Several tools were standalone tools (11, 73%), while most of the tools supported communication intervention–related lifestyle or behavioral changes (13, 87%) and medication adherence (6, 40%). It was found that physicians (9, 60%), allied health professionals (5, 33%), and nurses (5, 33%) were the health care providers who generally used these tools for communicating with their patients. More than half of the above tools (10, 67%) were assessed by different researchers in randomized controlled trials, while 5 tools (33%) were investigated in nonrandomized studies. Conclusions: We identified many web-based intervention programs for patients with hypertension from the literature databases. The findings indicate that numerous benefits can be derived after using a web-based dietary and physical activity intervention program for hypertension focusing on lifestyle changes. However, developers need to consider the preferences of the patients with regard to the information or the design features while developing or modifying web-based educational websites. These tools could be used for designing a patient-tailored website intervention program that is based on diet and physical activities for patients with hypertension. %M 33720036 %R 10.2196/22465 %U https://www.jmir.org/2021/3/e22465 %U https://doi.org/10.2196/22465 %U http://www.ncbi.nlm.nih.gov/pubmed/33720036 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e24590 %T Commencement of and Retention in Web-Based Interventions and Response to Prompts and Reminders: Longitudinal Observational Study Based on Two Randomized Controlled Trials %A Andriopoulos,Athanasios %A Olsson,Erik M G %A Hägg Sylvén,Ylva %A Sjöström,Jonas %A Johansson,Birgitta %A von Essen,Louise %A Grönqvist,Helena %+ Department of Women's and Children's Health, Uppsala University, Akademiska sjukhuset, Uppsala, 75185, Sweden, 46 736236500, helena.gronqvist@kbh.uu.se %K log data analysis %K use pattern %K retention %K dropout %K attrition %K online intervention %K online data %D 2021 %7 12.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based interventions are effective for several psychological problems. However, recruitment, adherence, and missing data are challenges when evaluating these interventions. Objective: This study aimed to describe the use patterns during the commencement phase, possible retention patterns (continuation of data provision), and responses to prompts and reminders among participants in 2 randomized controlled trials (RCTs) evaluating web-based interventions. Methods: Data on use patterns logged in 2 RCTs aiming to reduce symptoms of anxiety and depression among adult patients recently diagnosed with cancer (AdultCan RCT) and patients with a recent myocardial infarction (Heart RCT) were analyzed. The web-based intervention in the AdultCan trial consisted of unguided self-help and psychoeducation and that in the Heart trial consisted of therapist-supported cognitive behavioral therapy. In total, 2360 participants’ use patterns at first log-in, including data collection at baseline (ie, commencement) and at 2 follow-ups, were analyzed. Both the intervention and comparison groups were analyzed. Results: At commencement, 70.85% (909/1283) and 86.82% (935/1077) of the participants in AdultCan and Heart RCTs, respectively, logged in and completed baseline data collection after receiving a welcome email with log-in credentials. The median duration of the first log-in was 44 minutes and 38 minutes in AdultCan and Heart RCTs, respectively. Slightly less than half of the participants’ first log-ins were completed outside standard office hours. More than 80% (92/114 and 103/111) of the participants in both trials explored the intervention within 2 weeks of being randomized to the treatment group, with a median duration of 7 minutes and 47 minutes in AdultCan and Heart RCTs, respectively. There was a significant association between intervention exploration time during the first 2 weeks and retention in the Heart trial but not in the AdultCan trial. However, the control group was most likely to retain and provide complete follow-up data. Across the 3 time points of data collection explored in this study, the proportion of participants responding to all questionnaires within 1 week from the prompt, without a reminder, varied between 35.45% (413/1165) and 66.3% (112/169). After 2 reminders, up to 97.6% (165/169) of the participants responded. Conclusions: Most participants in both RCTs completed the baseline questionnaires within 1 week of receiving the welcome email. Approximately half of them answered questions at baseline data collection outside office hours, suggesting that the time flexibility inherent in web-based interventions contributes to commencement and use. In contrast to what was expected, the intervention groups generally had lower completion rates than the comparison groups. About half of the participants completed the questionnaires without a reminder, but thereafter, reminders contributed to both baseline and follow-up retention, suggesting they were effective. Strategies to increase commencement of and retention in eHealth interventions are important for the future development of effective interventions and relevant research. %M 33709937 %R 10.2196/24590 %U https://www.jmir.org/2021/3/e24590 %U https://doi.org/10.2196/24590 %U http://www.ncbi.nlm.nih.gov/pubmed/33709937 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e22564 %T An Interactive Web-Based Sexual Health Literacy Program for Safe Sex Practice for Female Chinese University Students: Multicenter Randomized Controlled Trial %A Wong,Janet Yuen-Ha %A Zhang,Wen %A Wu,Yongda %A Choi,Edmond Pui Hang %A Lo,Herman Hay Ming %A Wong,Wendy %A Chio,Jasmine Hin Man %A Tam,Hau Lin Cherry %A Ngai,Fei Wan %A Tarrant,Marie %A Wang,Man Ping %A Ngan,Hextan Yuen-Sheung %A Fong,Daniel Yee-Tak %+ School of Nursing, University of Hong Kong, Pokfulam, Hong Kong SAR, Hong Kong, 852 39176645, dytfong@hku.hk %K sexual health %K eHealth %K women's health %K sex education %K health literacy %D 2021 %7 12.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Sexual health concerns among young adults worldwide help to motivate preventative practices against sexually transmitted infections. To foster better sexual health, sexual health literacy must be enhanced. Little research has been conducted on the impact of gender power dynamics on sexual health, such as sexual coercion, even though the prevalence of sexual coercion remains high in China. Objective: This study describes the development and systematic evaluation of a web-based sexual health literacy intervention called “Smart Girlfriend” for female Chinese university students. Methods: A multicenter randomized controlled trial was conducted with 781 female university students at 5 universities with dormitories in Hong Kong. Inclusion criteria were used to select unmarried, female, Chinese university students who were ≥18 years old and had not received a sexual health intervention in the past 12 months. Participants were randomly assigned to 2 groups: one group received an interactive web-based sexual health literacy intervention and the other group received a single webpage of online information about condom use. The intervention content was based on the Health Belief Model and the Continuum of Conflict and Control theory. The primary outcome was self-reported consistency of condom use with every partner at 3-month and 6-month follow-up assessments, analyzed using zero/one inflated beta (ZOIB) regression. The secondary outcome was an appraisal of the knowledge, attitudes, norms, and self-efficacy of condom use using the 25-item Multidimensional Condom Attitudes Scale (MCAS). The intention to treat was applied in analyses. Results: Of 1503 individuals that were screened, 781 (52%) were randomized into 2 groups. The retention rates at the 3-month and 6-month follow-ups were 92% and 91%, respectively. Most participants were born locally (536/746, 72%), and 18% (134/746) self-reported as a sexual minority. ZOIB results regarding the consistency of condom use were not significant [model 1: odds ratio (OR) 2.25 with a 95% credible interval (CrI) of 0.84-6.36; model 2: OR 8.03 (95% CrI 0.22-330.31); model 3: OR 1.21 (95% CrI 0.78-1.86)]. Consistency in the intervention group was 5% higher (95% CI −1.90 to 11.63) than the control group at the 3-month follow-up, and 1% higher (95% CI −5.81 to 8·02) at the 6-month follow-up. MCAS scores at the 3-month follow-up were significantly higher in the intervention group (mean 122.51, SD 15.97) than the control group (mean 119.86, SD 15.85; P=.02). Conclusions: An interactive web-based sexual health literacy program did not significantly increase the consistency of condom use compared to a single webpage of condom use information; however, it did temporarily improve knowledge, attitudes, norms, and self-efficacy regarding condom use. Future revisions of this intervention should be personalized and delivered with a proactive approach. Trial Registration: ClinicalTrials.gov NCT03695679; https://clinicaltrials.gov/ct2/show/NCT03695679 %M 33709941 %R 10.2196/22564 %U https://www.jmir.org/2021/3/e22564 %U https://doi.org/10.2196/22564 %U http://www.ncbi.nlm.nih.gov/pubmed/33709941 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e24905 %T Effort-Optimized Intervention Model: Framework for Building and Analyzing Digital Interventions That Require Minimal Effort for Health-Related Gains %A Baumel,Amit %A Muench,Frederick J %+ Partnership to End Addiction, 711 Third Avenue, New York, NY, 10017, United States, 1 9175320623, fmuench@toendaddiction.org %K behavior change %K digital health %K mental health %K addiction %K intervention %K behavioral health %K effort %K salience %K persuasive design %D 2021 %7 12.3.2021 %9 Viewpoint %J J Med Internet Res %G English %X The majority of digital health interventions lean on the promise of bringing health and self-care into people’s homes and hands. However, these interventions are delivered while people are in their triggering environments, which places competing demands on their attention. Individuals struggling to change or learn a new behavior have to work hard to achieve even a minor change because of the automatic forces propelling them back to their habitual behaviors. We posit that effort and burden should be explored at the outset and throughout the digital intervention development process as a core therapeutic mechanism, beyond the context of design or user experience testing. In effort-focused conceptualization, it is assumed that, even though goals are rational and people want to achieve them, they are overtaken by competing cognitive, emotional, and environmental processes. We offer the term effort-optimized intervention to describe interventions that focus on user engagement in the face of competing demands. We describe design components based on a 3-step process for planning an effort-optimized intervention: (1) nurturing effortless cognitive and environmental salience to help people keep effort-related goals prominent despite competition; (2) making it as effortless as possible to complete therapeutic activities to avoid ego depletion and self-efficacy reduction; and (3) turning the necessary effortful activities into sustainable assets. We conclude by presenting an example of designing a digital health intervention based on the effort-optimized intervention model. %M 33709943 %R 10.2196/24905 %U https://www.jmir.org/2021/3/e24905 %U https://doi.org/10.2196/24905 %U http://www.ncbi.nlm.nih.gov/pubmed/33709943 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e24906 %T Risk Factors and Leadership in a Digitalized Working World and Their Effects on Employees’ Stress and Resources: Web-Based Questionnaire Study %A Bregenzer,Anita %A Jimenez,Paulino %+ Institute of Psychology, University of Graz, Universitätsplatz 2, Graz, 8010, Austria, 43 316380 ext 5128, paul.jimenez@uni-graz.at %K digitalization %K leadership %K new ways of working %K resources %K stress %D 2021 %7 12.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: In today’s world of work, the digitalization of work and communication processes is increasing, and will increase even further. This increase in digitalization at the workplace brings many new aspects of working life to light, such as working in virtual teams, mobile working, expectations of being constantly available, and the need for support in adapting and learning new digital tools. These changes to the workplace can contain risks that might harm the well-being of employees. Leaders can support the well-being of their employees in terms of protecting and replenishing their work-related resources to cope with critical work demands. This so-called health-promoting leadership could serve as a buffer between risk at the workplace and critical outcomes, such as stress, by amplifying work-related resources. Objective: This study’s aims were twofold. First, we wanted to investigate if risk factors related to higher digitalization at the workplace can be identified and if these risk factors have an impairing effect on the well-being of employees (eg, higher stress and lower resources). Second, we wanted to investigate if the health-impairing effects of these risk factors can be reduced by health-promoting leadership. Methods: A total of 1412 employees from Austria, Germany, and Switzerland took part in this online study and provided information on their perceived risks at the workplace, their leaders’ health-promoting behaviors, and their work-related stress and resources. Results: The results of a hierarchical regression analysis showed that all four risk factors of digital work (distributed team work, mobile work, constant availability, and inefficient technical support) were related to higher stress at the workplace. In addition, distributed team work and inefficient technical support were associated with lower work-related resources. A possible buffer effect of health-promoting leadership between these risks and employee well-being was visible for inefficient technical support. In particular, in the case of having fewer support opportunities in learning and using digital tools, leaders could weaken the potential critical effects on stress. As for the other risk factors, leaders might engage in a different leadership behavior to improve their employees’ well-being, as the physical distance between leaders and employees in virtual team work or mobile work could make health-promoting leadership more difficult. Conclusions: In a digitalized working world, solutions are needed to create working conditions that benefit employees. The results of this study strongly support the importance of investigating risk factors associated with an increase in digitalization at the workplace in addition to traditional risk factors. As for leadership, leaders need to show leadership behavior adapted to a digitalized workplace in order to reduce employee stress and increase work-related resources. %M 33709933 %R 10.2196/24906 %U https://www.jmir.org/2021/3/e24906 %U https://doi.org/10.2196/24906 %U http://www.ncbi.nlm.nih.gov/pubmed/33709933 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e24135 %T Electronic Health Risk Behavior Screening With Integrated Feedback Among Adolescents in Primary Care: Randomized Controlled Trial %A Richardson,Laura %A Parker,Elizabeth Oshrin %A Zhou,Chuan %A Kientz,Julie %A Ozer,Elizabeth %A McCarty,Carolyn %+ Seattle Children's Research Institute, 1900 9th Ave, Seattle, WA, 98101, United States, 1 (206) 884 7300, laura.richardson@seattlechildrens.org %K adolescent health services %K primary care %D 2021 %7 12.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Health risk behaviors are the most common sources of morbidity among adolescents. Adolescent health guidelines (Guidelines for Preventive Services by the AMA and Bright Futures by the Maternal Child Health Bureau) recommend screening and counseling, but the implementation is inconsistent. Objective: This study aims to test the efficacy of electronic risk behavior screening with integrated patient-facing feedback on the delivery of adolescent-reported clinician counseling and risk behaviors over time. Methods: This was a randomized controlled trial comparing an electronic tool to usual care in five pediatric clinics in the Pacific Northwest. A total of 300 participants aged 13-18 years who attended a well-care visit between September 30, 2016, and January 12, 2018, were included. Adolescents were randomized after consent by employing a 1:1 balanced age, sex, and clinic stratified schema with 150 adolescents in the intervention group and 150 in the control group. Intervention adolescents received electronic screening with integrated feedback, and the clinicians received a summary report of the results. Control adolescents received usual care. Outcomes, assessed via online survey methods, included adolescent-reported receipt of counseling during the visit (measured a day after the visit) and health risk behavior change (measured at 3 and 6 months after the visit). Results: Of the original 300 participants, 94% (n=282), 94.3% (n=283), and 94.6% (n=284) completed follow-up surveys at 1 day, 3 months, and 6 months, respectively, with similar levels of attrition across study arms. The mean risk behavior score at baseline was 2.86 (SD 2.33) for intervention adolescents and 3.10 (SD 2.52) for control adolescents (score potential range 0-21). After adjusting for age, gender, and random effect of the clinic, intervention adolescents were 36% more likely to report having received counseling for endorsed risk behaviors than control adolescents (adjusted rate ratio 1.36, 95% CI 1.04 to 1.78) 1 day after the well-care visit. Both the intervention and control groups reported decreased risk behaviors at the 3- and 6-month follow-up assessments, with no significant group differences in risk behavior scores at either time point (3-month group difference: β=−.15, 95% CI −0.57 to −0.01, P=.05; 6-month group difference: β=−.12, 95% CI −0.29 to 0.52, P=.57). Conclusions: Although electronic health screening with integrated feedback improves the delivery of counseling by clinicians, the impact on risk behaviors is modest and, in this study, not significantly different from usual care. More research is needed to identify effective strategies to reduce risk in the context of well-care. Trial Registration: ClinicalTrials.gov NCT02882919; https://clinicaltrials.gov/ct2/show/NCT02882919 %M 33709942 %R 10.2196/24135 %U https://www.jmir.org/2021/3/e24135 %U https://doi.org/10.2196/24135 %U http://www.ncbi.nlm.nih.gov/pubmed/33709942 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e18348 %T e-Mental Health Program Usage Patterns in Randomized Controlled Trials and in the General Public to Inform External Validity Considerations: Sample Groupings Using Cluster Analyses %A Sanatkar,Samineh %A Baldwin,Peter %A Huckvale,Kit %A Christensen,Helen %A Harvey,Samuel %+ Black Dog Institute, The University of New South Wales Sydney, Hospital Road, Randwick, 2031, Australia, 61 9382 4368, s.sanatkar@unsw.edu.au %K e-mental health %K engagement patterns %K external validity %K randomized controlled trial %K community sample %D 2021 %7 11.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Randomized controlled trials (RCTs) with vigorous study designs are vital for determining the efficacy of treatments. Despite the high internal validity attributed to RCTs, external validity concerns limit the generalizability of results to the general population. Bias can be introduced, for example, when study participants who self-select into a trial are more motivated to comply with study conditions than are other individuals. These external validity considerations extend to e-mental health (eMH) research, especially when eMH tools are designed for public access and provide minimal or no supervision. Objective: Clustering techniques were employed to identify engagement profiles of RCT participants and community users of a self-guided eMH program. This exploratory approach inspected actual, not theorized, RCT participant and community user engagement patterns. Both samples had access to the eMH program over the same time period and received identical usage recommendations on the eMH program website. The aim of this study is to help gauge expectations of similarities and differences in usage behaviors of an eMH tool across evaluation and naturalistic contexts. Methods: Australian adults signed up to myCompass, a self-guided online treatment program created to reduce mild to moderate symptoms of negative emotions. They did so either by being part of an RCT onboarding (160/231, 69.6% female) or by accessing the program freely on the internet (5563/8391, 66.30% female) between October 2011 and October 2012. During registration, RCT participants and community users provided basic demographic information. Usage metrics (number of logins, trackings, and learning activities) were recorded by the system. Results: Samples at sign-up differed significantly in age (P=.003), with community users being on average 3 years older (mean 41.78, SD 13.64) than RCT participants (mean 38.79, SD 10.73). Furthermore, frequency of program use was higher for RCT participants on all usage metrics compared to community users through the first 49 days after registration (all P values <.001). Two-step cluster analyses revealed 3 user groups in the RCT sample (Nonstarters, 10-Timers, and 30+-Timers) and 2 user groups in the community samples (2-Timers and 20-Timers). Groups seemed comparable in patterns of use but differed in magnitude, with RCT participant usage groups showing more frequent engagement than community usage groups. Only the high-usage group among RCT participants approached myCompass usage recommendations. Conclusions: Findings suggested that external validity concerns of RCT designs may arise with regards to the predicted magnitude of eMH program use rather than overall usage styles. Following up RCT nonstarters may help provide unique insights into why individuals choose not to engage with an eMH program despite generally being willing to participate in an eMH evaluation study. Overestimating frequency of engagement with eMH tools may have theoretical implications and potentially impact economic considerations for plans to disseminate these tools to the general public. %M 33704070 %R 10.2196/18348 %U https://www.jmir.org/2021/3/e18348 %U https://doi.org/10.2196/18348 %U http://www.ncbi.nlm.nih.gov/pubmed/33704070 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e24006 %T User-Centered Development of a Web Platform Supporting Community-Based Health Care Organizations for Older Persons in Need of Support: Qualitative Focus Group Study %A Biehl,Verena %A Becker,Heidrun %A Ogrin,Alenka %A Reissner,Alenka %A Burger,Johannes %A Glaessel,Andrea %+ Institute of Health Sciences, Zurich University of Applied Sciences, Katharina-Sulzer-Platz 9, Winterthur, CH-8401, Switzerland, 41 58 934 4397, andrea.glaessel@zhaw.ch %K community-based health care services %K older persons in need of support %K user-centered design %K focus groups %K qualitative research %K web platform %D 2021 %7 10.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The ongoing changes in population demographics increase the relevance of dignified aging across Europe. Community-based health care (CBHC) organizations are necessary to provide sustainable strategies for organizing care for older persons in need of support. To support the digitalization of these organizations, new business models and suitable web platforms are necessary. Objective: This study, which is part of the European Active and Assisted Living (AAL) project called “ICareCoops”, aimed to explore concepts, approaches, and workflows of CBHC organizations to achieve a comprehensive understanding of extant services offered and relevant requirements to support these services with information and computer technology (ICT) solutions. Methods: A qualitative study with six focus groups (FGs) with 40 participants was conducted in Switzerland and Slovenia to identify potential stakeholders’ needs and requirements for the user-centered development of a web platform. Data were collected from three different stakeholder groups: (1) older persons in need of support as care receivers, (2) significant others of older persons in need of support, and (3) managers or care providers of CBHC organizations. A semistructured interview guide with open questions was used for data collection. FG sessions were audio-recorded and transcribed verbatim. Thematic content analysis was used to analyze the content of the FG sessions. To assist with further web platform development, the responses of the FG participants were translated into user stories to describe technical requirements. Results: By analyzing the transcripts, five main categories were identified: (1) ICT usage behavior of users, (2) challenges of web platform usage, (3) content and technical requirements for the web platform, (4) form and services of CBHC organizations, and (5) rationales of CBHC organizations. The main issues identified were the need for seniors to have individual contact with the CBHC organization and the possibility to coordinate routine services via the web platform, such as ordering meals-on-wheels or booking a caregiver to accompany an older person to the doctor. Conclusions: The majority of participants showed a lack of familiarity with the usage of ICT. Nevertheless, they were open-minded regarding web platform usage to facilitate workflows and to benefit CBHC organizations. Cooperatives as an organizational model demonstrate a high potential to address users’ needs. Therefore, the web platform offers an essential tool for innovative health care models in the future. Searching for care services, contacting care providers, and communicating with care providers was preferred via personal contact and seemed to be the key element for user acceptance and for the successful implementation of a web platform like “ICareCoops” to support CBHC organizations. %M 33688837 %R 10.2196/24006 %U https://www.jmir.org/2021/3/e24006 %U https://doi.org/10.2196/24006 %U http://www.ncbi.nlm.nih.gov/pubmed/33688837 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e24380 %T Online Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth With Major Depressive Disorders: Randomized Controlled Trial %A Ritvo,Paul %A Knyahnytska,Yuliya %A Pirbaglou,Meysam %A Wang,Wei %A Tomlinson,George %A Zhao,Haoyu %A Linklater,Renee %A Bai,Shari %A Kirk,Megan %A Katz,Joel %A Harber,Lillian %A Daskalakis,Zafiris %+ Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, United States, 1 (858) 534 2230, zdaskalakis@health.ucsd.edu %K intervention study %K telemedicine %K electronic CBT %K clinical trial %K depression %K cognitive behavioral therapy %K CBT %K online therapy %K online intervention %K youth %K young adult %D 2021 %7 10.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Approximately 70% of mental health disorders appear prior to 25 years of age and can become chronic when ineffectively treated. Individuals between 18 and 25 years old are significantly more likely to experience mental health disorders, substance dependencies, and suicidality. Treatment progress, capitalizing on the tendencies of youth to communicate online, can strategically address depressive disorders. Objective: We performed a randomized controlled trial (RCT) that compared online mindfulness-based cognitive behavioral therapy (CBT-M) combined with standard psychiatric care to standard psychiatric care alone in youth (18-30 years old) diagnosed with major depressive disorder. Methods: Forty-five participants were randomly assigned to CBT-M and standard care (n=22) or to standard psychiatric care alone (n=23). All participants were provided standard psychiatric care (ie, 1 session per month), while participants in the experimental group received an additional intervention consisting of the CBT-M online software program. Interaction with online workbooks was combined with navigation coaching delivered by phone and secure text messaging. Results: In a two-level linear mixed-effects model intention-to-treat analysis, significant between-group differences were found for the Beck Depression Inventory-II score (difference –8.54, P=.01), Quick Inventory of Depressive Symptoms score (difference –4.94, P=.001), Beck Anxiety Inventory score (difference –11.29, P<.001), and Brief Pain Inventory score (difference –1.99, P=.03), while marginal differences were found for the Five Facet Mindfulness Questionnaire–Nonjudging subscale (difference –2.68, P=.05). Conclusions: These results confirm that youth depression can be effectively treated with online CBT-M that can be delivered with less geographic restriction. Trial Registration: Clinical Trials.gov NCT03406052; https://www.clinicaltrials.gov/ct2/show/NCT03406052 %M 33688840 %R 10.2196/24380 %U https://www.jmir.org/2021/3/e24380 %U https://doi.org/10.2196/24380 %U http://www.ncbi.nlm.nih.gov/pubmed/33688840 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 3 %P e24534 %T The Impact of a Web-Based Mindfulness, Nutrition, and Physical Activity Platform on the Health Status of First-Year University Students: Protocol for a Randomized Controlled Trial %A Trottier,Claire F %A Lieffers,Jessica R L %A Johnson,Steven T %A Mota,João F %A Gill,Roshni K %A Prado,Carla M %+ Human Nutrition Research Unit, Department of Agricultural, Food and Nutritional Science, University of Alberta, 2-004 Li Ka Shing Centre for Health and Innovation, 8602 - 112 Street, Edmonton, AB, T6G 2R3, Canada, 1 780 492 7934, cprado@ualberta.ca %K internet-based intervention %K wellness programs %K dietary intake %K physical activity %K mindfulness %K quality of life %K randomized controlled trial %D 2021 %7 10.3.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: First-year university students are at an increased risk for developing mental health issues and a poor nutritional status. Self-care plays an essential role in optimizing mental health and can prevent or manage stress, anxiety, and depression. Web-based self-monitoring of diet and physical activity can lead to similar or improved health outcomes compared with conventional methods. Such tools are also popular among university students. Objective: The primary aim of this 12-week randomized controlled trial is to assess the impact of a web-based wellness platform on perceived stress among first-year university students. The secondary aim is to assess the effects of the platform on diet quality. The exploratory objectives are to explore the effects of the platform on body composition, health-related quality of life, mindfulness, mental well-being, and physical activity. Methods: A total of 97 first-year undergraduate students were randomized to either the intervention (n=48) or control (n=49) group. The intervention consisted of access to a web-based platform called My Viva Plan (MVP), which aims to support healthy living by focusing on the topics of mindfulness, nutrition, and physical activity. The platform is fully automated and guided by the principles of cognitive behavioral theory. Participants in the intervention group were instructed to use the MVP as frequently as possible over 12 weeks. The control group did not receive access to MVP. Perceived stress was assessed using the Stress Indicators Questionnaire at baseline, week 6, and week 12. Three-day food records were used to analyze the dietary intake at baseline and week 12. Health-related quality of life, mindfulness, mental well-being, and physical activity questionnaires were completed at baseline, week 6, and week 12. Body composition was assessed at baseline and week 12. Study assessments were completed in person at baseline and week 12 and electronically at week 6. Results: Study recruitment started in August 2018, with batch enrollment for students registered in the fall (September 2018 to December 2018) and winter (January 2019 to April 2019) academic terms at the University of Alberta, Edmonton, Alberta. Conclusions: This study is the first to explore the impact of a web-based platform designed to promote health and wellness on perceived stress and diet quality among first-year university students. Trial Registration: ClinicalTrials.gov NCT03579264; https://clinicaltrials.gov/ct2/show/NCT03579264. International Registered Report Identifier (IRRID): DERR1-10.2196/24534 %M 33688844 %R 10.2196/24534 %U https://www.researchprotocols.org/2021/3/e24534 %U https://doi.org/10.2196/24534 %U http://www.ncbi.nlm.nih.gov/pubmed/33688844 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e17438 %T Opportunities and Challenges for Digital Social Prescribing in Mental Health: Questionnaire Study %A Patel,Shivani %A Craigen,Gerry %A Pinto da Costa,Mariana %A Inkster,Becky %+ South London and Maudsley NHS Trust, Denmark Hill, London, United Kingdom, 44 3228 6000 ext 1234, shivaninpatel183@gmail.com %K mental health %K technology %K psychiatry %K mobile phone %D 2021 %7 9.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The concept of digital social prescription usually refers to social prescriptions that are facilitated by using technology. Tools that enable such digital social prescriptions may be beneficial in recommending nonmedical activities to people with mental illness. As these tools are still somewhat novel and emerging, little is known about their potential advantages and disadvantages. Objective: The objective of this study is to identify the potential opportunities and challenges that may arise from digital social prescriptions. Methods: We developed a qualitative questionnaire that was disseminated through social media (Facebook and Twitter). A purposive sample targeting digital mental health experts and nonexperts was approached. The questionnaire asked participants’ views about digital social prescription; the core elements linked with a definition of digital social prescription; and the strengths, weaknesses, opportunities, and threats associated with digital social prescription. Results: Four core elements were recommended to define the concept of digital social prescription: digital, facilitate, user, and social. The main strength identified was the possibility to rapidly start using digital social prescription tools, which were perceived as cost-effective. The main weaknesses were their poor adherence and difficulties with using such tools. The main opportunities were an increased access to social prescription services and the prevention of serious mental illness. The main threats were certain groups being disadvantaged, patients being subject to unintended negative consequences, and issues relating to confidentiality and data protection. Conclusions: Although digital social prescriptions may be able to effectively augment the social prescriptions, a careful consideration of practical challenges and data ethics is imperative in the design and implementation of such technologies. %M 33687338 %R 10.2196/17438 %U https://www.jmir.org/2021/3/e17438 %U https://doi.org/10.2196/17438 %U http://www.ncbi.nlm.nih.gov/pubmed/33687338 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 3 %P e23613 %T Development of a Web-Based Intervention Course to Promote Students’ Well-Being and Studying in Universities: Protocol for an Experimental Study Design %A Asikainen,Henna %A Katajavuori,Nina %+ Faculty of Educational Sciences, University of Helsinki, Viikinkaari 9, PO Box 59, Helsinki, 00014, Finland, 358 445532494, henna.asikainen@helsinki.fi %K approaches to learning %K psychological flexibility %K well-being %K online intervention tool %K peer support %K reflection %D 2021 %7 9.3.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: The decline in the well-being among university students well as increasing dropouts has become a serious issue in universities around the world. Thus, effective ways to support students’ well-being and their ability to study are highly needed. Objective: The purpose of this study was to build an intervention course for university students, which promotes both students’ well-being as well as their learning and study skills, and to describe the experimental study design that explores the effects of this intervention course. Methods: Research has shown that psychological flexibility has a great effect on the well-being as well as the study skills of students pursuing higher education. The basis of our intervention course was to promote psychological flexibility and students’ study skills with the help of peer support and reflection. Results: This course was offered as a voluntary course to all the students at the University of Helsinki twice during the academic year 2020-2021. The first course was from October to December and the second course was from January to March. This course was advertised in fall 2020 through social media and by different student organizations and program leaders at different faculties of the University of Helsinki. As of October 2020, we enrolled 566 students comprising 310 students for the course in fall 2020 and 256 students for the course in spring 2021. Of the 256 students who enrolled in the second course, 170 students voluntarily participated in this study and they answered the questionnaires, including all the measures, simultaneously with the participants in the first group and thus served as the control group. The effect of this course will be measured with multiple data, including questionnaire data, reflective journals, and physiological data of well-being with a longitudinal experimental design. This research very strictly follows the ethical guidelines drawn up by the Finnish National Board on Research Integrity. We expect to publish the results of this study in fall 2021 at the latest. Conclusions: We argue that a web-based, 8-week intervention course, which promotes both student well-being and their study skills, is a good way to support students pursuing higher education, and both aspects should be considered when supporting university students. International Registered Report Identifier (IRRID): DERR1-10.2196/23613 %M 33687336 %R 10.2196/23613 %U https://www.researchprotocols.org/2021/3/e23613 %U https://doi.org/10.2196/23613 %U http://www.ncbi.nlm.nih.gov/pubmed/33687336 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e25885 %T Designing the Optimal Digital Health Intervention for Patients’ Use Before and After Elective Orthopedic Surgery: Qualitative Study %A Robinson,Anna %A Slight,Robert D %A Husband,Andrew K %A Slight,Sarah P %+ School of Pharmacy, Newcastle University, King George VI Building, Newcastle University, Newcastle upon Tyne, NE1 7RU, United Kingdom, 44 191 208 6000, Sarah.slight@newcastle.ac.uk %K digital technology %K orthopedic surgery %K behavior change %K perioperative care %K prehabilitation %K qualitative research %K mHealth %K eHealth %K mobile phone %D 2021 %7 8.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Health behavior changes made by patients during the perioperative period can impact the outcomes and success of elective surgeries. However, there remains a limited understanding of how best to support patients during this time, particularly through the use of digital health interventions. Recognizing and understanding the potential unmet needs of elective orthopedic surgery patients is central to motivating healthier behavior change, improving recovery, and optimizing overall surgical success in the short and long term. Objective: The aim of this study is to explore patient perspectives on technology features that would help support them to change their lifestyle behaviors during the pre- and postoperative periods, and that could potentially maintain long-term healthy lifestyles following recovery. Methods: Semistructured interviews with pre- and postoperative elective orthopedic patients were conducted between May and June 2020 using telephone and video call–based software. Patient perspectives on the use of digital technologies to complement current surgical care and support with lifestyle behavior changes were discussed. Interviews were audio recorded and transcribed verbatim. Reflexive thematic analysis enabled the development of themes from the data, with QSR NVivo software (version 12) facilitating data management. Ethical approval was obtained from the National Health Service Health Research Authority. Results: A total of 18 participants were interviewed. Four themes were developed from the data regarding the design and functionality of digital technologies to best support the perioperative journey. These center around an intervention’s ability to incorporate interactive, user-centered features; direct a descriptive and structured recovery; enable customizable, patient-controlled settings; and deliver both general and specific surgical advice in a timely manner. Interventions that are initiated preoperatively and continued postoperatively were perceived as beneficial. Interventions designed with personalized milestones were found to better guide patients through a structured recovery. Individualized tailoring of preparatory and recovery information was desired by patients with previously high levels of physical activity before surgery. The use of personalized progression-based exercises further encouraged physical recovery; game-like rewards and incentives were regarded as motivational for making and sustaining health behavior change. In-built video calling and messaging features offered connectivity with peers and clinicians for supported care delivery. Conclusions: Specific intervention design and functionality features can provide better, structured support for elective orthopedic patients across the entire surgical journey and beyond. This study provides much-needed evidence relating to the optimal design and timing of digital interventions for elective orthopedic surgical patients. Findings from this study suggest a desire for personalized perioperative care, in turn, supporting patients to make health behavior changes to optimize surgical success. These findings should be used to influence future co-design projects to enable the design and implementation of patient-focused, tailored, and targeted digital health technologies within modern health care settings. %M 33683208 %R 10.2196/25885 %U https://www.jmir.org/2021/3/e25885 %U https://doi.org/10.2196/25885 %U http://www.ncbi.nlm.nih.gov/pubmed/33683208 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 3 %P e20036 %T Transdiagnostic Internet Intervention for Indonesian University Students With Depression and Anxiety: Evaluation of Feasibility and Acceptability %A Rahmadiana,Metta %A Karyotaki,Eirini %A Schulte,Mieke %A Ebert,David Daniel %A Passchier,Jan %A Cuijpers,Pim %A Berger,Thomas %A van Ballegooijen,Wouter %A Wimbarti,Supra %A Riper,Heleen %+ Department of Clinical, Neuro and Developmental Psychology, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, Amsterdam, 1081 BT, Netherlands, 31 20 5988951, m.r.rahmadiana@vu.nl %K anxiety %K cultural adaptation %K depression %K guided %K internet-based intervention %K transdiagnostic %K university students %D 2021 %7 5.3.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: University students with depression and anxiety do not easily receive or seek treatment; therefore, internet-based interventions have been suggested to be a promising way to improve treatment accessibility and availability. However, it has not been examined whether a guided, culturally adapted, transdiagnostic, internet-based intervention is effective for treating symptoms of depression, anxiety, or both among university students in Indonesia. Objective: This study aims to investigate the feasibility (acceptability and satisfaction, usability, and uptake) of a guided, culturally adapted, transdiagnostic, internet-based intervention among university students with symptoms of depression, anxiety, or both in Indonesia. Methods: Students from Universitas Gadjah Mada, Yogyakarta, Indonesia, were screened for symptoms of depression, anxiety, or both, and filled online informed consent, demographic questionnaires, and a quality of life measure at pretreatment assessment (T0). Subsequently, the participants started the intervention. Seven weeks after T0, the primary outcomes of this feasibility study were analyzed at posttreatment assessment (T1) using the 8-item Client Satisfaction Questionnaire (CSQ-8) and the System Usability Scale (SUS). Mean and SDs for the CSQ-8 and SUS were calculated to examine feasibility. Within-group secondary outcomes (depression, anxiety, and quality of life) were inspected for outliers and normal distribution. Paired-sample t tests were used to investigate differences between time points of secondary outcomes. A mixed-method approach of quantitative and qualitative analyses was adopted. Both the primary and secondary outcomes were additionally explored with an individual semistructured interview and synthesized descriptively. Results: A total of 50 participants completed the intervention. We found a moderate to high level of satisfaction and acceptability, a slightly below-average level of desirable usability (≥70), and an adherence rate of 52% which was higher than expected given the novelty of the intervention. Results for the secondary outcomes indicated a decrease in depression and anxiety. For depression, the overall mean difference between the 2 time points for depression was 3.92 (95% CI 2.75-5.1; Hedges g 1.15; P<.001). For anxiety, the overall mean difference between the 2 time points was 3.34 (95% CI 2.06-4.61; Hedges g 1.02; P<.001). Further, a moderate effect in improving quality of life was found (g=0.50). Overall, participants were positive about the online intervention and ECoaches (online guidance), and they found the intervention to be culturally appropriate. Conclusions: A culturally adapted, transdiagnostic, internet-based intervention appears to be acceptable and feasible for reducing symptoms of depression, anxiety, or both, and increasing quality of life in university students in Indonesia. Future studies should include a randomized controlled trial to assess the effectiveness of such interventions as they may supplement existing counseling services in universities, reduce the treatment costs, and maximize treatment accessibility in low-resourced settings. International Registered Report Identifier (IRRID): RR2-10.1016/j.invent.2018.11.002 %M 33666553 %R 10.2196/20036 %U https://mental.jmir.org/2021/3/e20036 %U https://doi.org/10.2196/20036 %U http://www.ncbi.nlm.nih.gov/pubmed/33666553 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e18433 %T Association of Spontaneous and Induced Self-Affirmation With Smoking Cessation in Users of a Mobile App: Randomized Controlled Trial %A Seaman,Elizabeth L %A Robinson,Cendrine D %A Crane,David %A Taber,Jennifer M %A Ferrer,Rebecca A %A Harris,Peter R %A Klein,William M P %+ CDC Foundation, 600 Peachtree Street NE, Suite 1000, Atlanta, GA, 30308, United States, 1 4438524139, eseaman@cdcfoundation.org %K smoking cessation %K smartphone %K mHealth %K sadness %K self-affirmation %K spontaneous self-affirmation %K apps %K mobile phone %D 2021 %7 5.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Most smokers attempt to stop using cigarettes numerous times before successfully quitting. Cigarette cravings may undermine perceived competence to quit and thus constitute psychological threats to the individual’s self-concept. Self-affirmation may promote smoking cessation by offsetting these threats. Objective: This study examines whether self-affirmation is associated with smoking cessation in the context of a cessation app. Two types of self-affirmation are examined: tendency to spontaneously self-affirm, and self-affirmation inductions added to a publicly available smoking cessation app (Smoke-Free Quit Smoking Now). In addition, this study explores whether optimism and emotional states (happiness, anger, anxiousness, hopefulness, sadness) predict smoking cessation. Methods: All users who met the inclusion criteria, provided consent to participate, and completed a baseline assessment, including all individual difference measures, were randomized to 1 of 4 conditions. Half of the participants were randomly assigned to complete a self-affirmation induction upon study entry. Orthogonally, half of the participants were randomly assigned to receive self-affirming text notifications during their quit attempt or to receive conventional notifications. The induction and the text notifications were fully automated, and all data were collected through self-assessments in the app. Self-reported smoking cessation was assessed 1 month and 3 months following study entry. Results: The study enrolled 7899 participants; 647 completed the 1-month follow-up. Using an intent-to-treat analysis at the 1-month follow-up, 7.2% (569/7899) of participants self-reported not smoking in the previous week and 6.4% (503/7899) self-reported not smoking in the previous month. Greater tendency to spontaneously self-affirm predicted a greater likelihood of cessation (P<.001) at 1 month after controlling for smoking-related variables. Neither self-affirmation induction influenced cessation. In addition, spontaneous self-affirmation did not moderate the relationship between self-affirmation inductions and cessation. Greater baseline sadness was associated with a lower likelihood of reporting successful cessation. Optimism predicted past-week cessation at the 1-month follow-up, and both happiness and anger predicted past-month cessation at the 1-month follow-up; however, none of these potential predictors moderated the relationship between self-affirmation conditions and successful cessation. Conclusions: Spontaneous self-affirmation may be an important psychological resource for managing threats to self-concept during the smoking cessation process. Sadness may hinder quit attempts. Future research can explicate how spontaneous versus induced self-affirmation can promote smoking cessation and examine boundary conditions for the effectiveness of disseminated self-affirmation interventions. Trial Registration: ISRCTN Registry 56646695; https://www.isrctn.com/ISRCTN56646695 %M 33666561 %R 10.2196/18433 %U https://www.jmir.org/2021/3/e18433 %U https://doi.org/10.2196/18433 %U http://www.ncbi.nlm.nih.gov/pubmed/33666561 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e20829 %T Evaluating a Hybrid Web-Based Training Program for Panic Disorder and Agoraphobia: Randomized Controlled Trial %A Ebenfeld,Lara %A Lehr,Dirk %A Ebert,David Daniel %A Kleine Stegemann,Stefan %A Riper,Heleen %A Funk,Burkhardt %A Berking,Matthias %+ Leuphana University, Universitätsallee 1, Lüneburg, 21335, Germany, 49 4131 677 1708, lara.ebenfeld@gmail.com %K panic disorder %K agoraphobia %K treatment %K internet %K mobile phone %K randomized controlled trial %D 2021 %7 4.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Previous studies provide evidence for the effectiveness of web-based interventions for panic disorder with and without agoraphobia. Smartphone-based technologies hold significant potential for further enhancing the accessibility and efficacy of such interventions. Objective: This randomized controlled trial aims to evaluate the efficacy of a guided, hybrid web-based training program based on cognitive behavioral therapy for adults with symptoms of panic disorder. Methods: Participants (N=92) with total scores in the Panic and Agoraphobia Scale ranging from 9 to 28 were recruited from the general population and allocated either to a hybrid intervention (GET.ON Panic) or to a wait-list control group. The primary outcome was the reduction in panic symptoms, as self-assessed using a web-based version of the Panic and Agoraphobia Scale. Results: Analysis of covariance-based intention-to-treat analyses revealed a significantly stronger decrease in panic symptoms posttreatment (F=9.77; P=.002; Cohen d=0.66; 95% CI 0.24-1.08) in the intervention group than in the wait-list control group. Comparisons between groups of the follow-up measures at 3 and 6 months yielded even stronger effects (3-month follow-up: F=17.40, P<.001, Cohen d=0.89, 95% CI 0.46-1.31; 6-month follow-up: F=14.63, P<.001, Cohen d=0.81, 95% CI 0.38-1.24). Conclusions: Hybrid web-based training programs may help reduce the symptoms of panic disorder and hence play an important role in improving health care for patients with this debilitating disorder. Trial Registration: German Clinical Trial Register DRKS00005223; https://tinyurl.com/f4zt5ran International Registered Report Identifier (IRRID): RR2-10.1186/1745-6215-15-427 %M 33661121 %R 10.2196/20829 %U https://www.jmir.org/2021/3/e20829 %U https://doi.org/10.2196/20829 %U http://www.ncbi.nlm.nih.gov/pubmed/33661121 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 8 %N 1 %P e22944 %T Comparing an eHealth Program (My Hip Journey) With Standard Care for Total Hip Arthroplasty: Randomized Controlled Trial %A Saunders,Rosemary %A Seaman,Karla %A Emery,Laura %A Bulsara,Max %A Ashford,Catherine %A McDowall,Judith %A Gullick,Karen %A Ewens,Beverley %A Sullivan,Trudy %A Foskett,Charlotte %A Whitehead,Lisa %+ School of Nursing and Midwifery, Edith Cowan University, 270 Joondalup Drive, Joondalup, Australia, 61 8 6304 3513, rosemary.saunders@ecu.edu.au %K hip arthroplasty %K education %K eHealth program %K rehabilitation %K economic evaluation %D 2021 %7 3.3.2021 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: The role of eHealth programs to support patients through surgical pathways, including total hip arthroplasty (THA), is rapidly growing and offers the potential to improve patient engagement, self-care, and outcomes. Objective: The aim of this study is to compare the effects of an eHealth program (intervention) versus standard care for pre- and postoperative education on patient outcomes for primary THA. Methods: A prospective parallel randomized controlled trial with two arms (standard care and standard care plus access to the eHealth education program) was conducted. Participants included those who underwent THA. Outcome measures were collected preadmission, at 6 weeks, and at 3 and 6 months after surgery. The primary outcome was the Hip Dysfunction and Osteoarthritis Outcome Score. Secondary outcomes were a 5-level 5-dimension quality of life measure and the self-efficacy for managing chronic disease scale. Demographic and clinical characteristics were also collected. A satisfaction survey was completed by all participants 6 weeks after surgery, and those in the intervention arm completed an additional survey specific to the eHealth program. Results: A total of 99 patients were recruited: 50 in the eHealth program (intervention) and 49 in standard care (control). Clinical improvements were demonstrated in both groups across all time points. Per-protocol analysis demonstrated no differences between the groups for all outcome measures across all time points. Participants in the eHealth program reported that the program was accessible, that they felt comfortable using it, and that the information was helpful. Conclusions: This study demonstrated that the eHealth program, in addition to standard care, had no additional benefit to THA recovery compared with standard care alone. The study found that the eHealth program was highly valued by participants, and it supported the preoperative preparation, recovery, and postoperative rehabilitation of participants. Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12617001433392; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373657 %M 33656449 %R 10.2196/22944 %U https://rehab.jmir.org/2021/1/e22944 %U https://doi.org/10.2196/22944 %U http://www.ncbi.nlm.nih.gov/pubmed/33656449 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e15846 %T Effects of Information Architecture on the Effectiveness and User Experience of Web-Based Patient Education in Middle-Aged and Older Adults: Online Randomized Experiment %A Dekkers,Tessa %A Melles,Marijke %A Vehmeijer,Stephan B W %A de Ridder,Huib %+ Faculty of Behavioural, Management and Social sciences, University of Twente, Drienerlolaan 5, Enschede, 7522 NB, Netherlands, 31 534899741, t.dekkers@utwente.nl %K user-computer interface %K total joint replacement %K user-centered design %K health education %K mobile phone %K computer-assisted instruction %K patient education as topic %K models, theoretical %K middle aged %K aged %K humans %K internet %D 2021 %7 3.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based patient education is increasingly offered to improve patients’ ability to learn, remember, and apply health information. Efficient organization, display, and structural design, that is, information architecture (IA), can support patients’ ability to independently use web-based patient education. However, the role of IA in the context of web-based patient education has not been examined systematically. Objective: To support intervention designers in making informed choices that enhance patients’ learning, this paper describes a randomized experiment on the effects of IA on the effectiveness, use, and user experience of a patient education website and examines the theoretical mechanisms that explain these effects. Methods: Middle-aged and older adults with self-reported hip or knee joint complaints were recruited to use and evaluate 1 of 3 patient education websites containing information on total joint replacement surgery. Each website contained the same textual content based on an existing leaflet but differed in the employed IA design (tunnel, hierarchical, or matrix design). Participants rated the websites on satisfaction, engagement, control, relevance, trust, and novelty and completed an objective knowledge test. Analyses of variance and structural equation modeling were used to examine the effects of IA and construct a theoretical model. Results: We included 215 participants in our analysis. IA did not affect knowledge gain (P=.36) or overall satisfaction (P=.07) directly. However, tunnel (mean 3.22, SD 0.67) and matrix (mean 3.17, SD 0.69) architectures were found to provide more emotional support compared with hierarchical architectures (mean 2.86, SD 0.60; P=.002). Furthermore, increased perceptions of personal relevance in the tunnel IA (β=.18) were found to improve satisfaction (β=.17) indirectly. Increased perceptions of active control in the matrix IA (β=.11) also improved satisfaction (β=.27) indirectly. The final model of the IA effects explained 74.3% of the variance in satisfaction and 6.8% of the variance in knowledge and achieved excellent fit (χ217,215=14.7; P=.62; root mean square error of approximation=0.000; 95% CI [0.000-0.053]; comparative fit index=1.00; standardized root mean square residual=0.044). Conclusions: IA has small but notable effects on users’ experiences with web-based health education interventions. Web-based patient education designers can employ tunnel IA designs to guide users through sequentially ordered content or matrix IA to offer users more control over navigation. Both improve user satisfaction by increasing user perceptions of relevance (tunnel) and active control (matrix). Although additional research is needed, hierarchical IA designs are currently not recommended, as hierarchical content is perceived as less supportive, engaging, and relevant, which may diminish the use and, in turn, the effect of the educational intervention. %M 33656446 %R 10.2196/15846 %U https://www.jmir.org/2021/3/e15846 %U https://doi.org/10.2196/15846 %U http://www.ncbi.nlm.nih.gov/pubmed/33656446 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e19309 %T Development of a Web-Based Mindfulness Program for People With Multiple Sclerosis: Qualitative Co-Design Study %A Sesel,Amy-Lee %A Sharpe,Louise %A Beadnall,Heidi N %A Barnett,Michael H %A Szabo,Marianna %A Naismith,Sharon L %+ School of Psychology, University of Sydney, Camperdown NSW, Sydney, 2006, Australia, 61 2 9351 4558, amy-lee.sesel@sydney.edu.au %K multiple sclerosis %K mindfulness %K depression %K program development %K internet intervention %K qualitative research %D 2021 %7 2.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Mindfulness-based stress reduction is an efficacious treatment for people with chronic health problems; however, it is highly intensive and time-consuming, which is a barrier for service provision. Objective: This study aims to develop an internet-delivered adapted version of mindfulness-based stress reduction for people with multiple sclerosis to make the intervention more accessible. Methods: We co-designed a web-based mindfulness program with end users, that is, people with multiple sclerosis (N=19). Iterative feedback was also collected from a subsample of the initial group of end users (n=11), and the program was reviewed by experts (n=8). Results: We identified three main themes common to people with multiple sclerosis: dealing with uncertainty and fears for the future, grief and loss, and social isolation. These themes were incorporated into narratives throughout the program. People with multiple sclerosis who reviewed the program gave feedback that the program was relatable, feasible, and acceptable. Experts agreed that the program appropriately represented the main tenets of mindfulness. Iterative feedback was used to further refine the program. Conclusions: The web-based mindfulness program that we developed was viewed positively by both experts and end users. The program reflects common concerns for people with multiple sclerosis and has the potential to meet important unmet psychological needs. A randomized controlled trial was planned to determine the efficacy of the program. %M 33650980 %R 10.2196/19309 %U https://www.jmir.org/2021/3/e19309 %U https://doi.org/10.2196/19309 %U http://www.ncbi.nlm.nih.gov/pubmed/33650980 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 5 %N 1 %P e24524 %T Internet-Delivered Exposure-Based Therapy for Symptom Preoccupation in Atrial Fibrillation: Uncontrolled Pilot Trial %A Särnholm,Josefin %A Skúladóttir,Helga %A Rück,Christian %A Klavebäck,Sofia %A Ólafsdóttir,Eva %A Pedersen,Susanne S %A Braunschweig,Frieder %A Ljótsson,Brjánn %+ Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Nobelsv. 9, Stockholm, 171 65, Sweden, 46 736373295, josefin.sarnholm@ki.se %K atrial fibrillation %K arrhythmia %K cognitive behavior therapy %K quality of life %K anxiety %D 2021 %7 2.3.2021 %9 Original Paper %J JMIR Cardio %G English %X Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia in the adult population. AF is associated with a poor quality of life (QoL) and, in many patients, current medical treatments are inadequate in alleviating AF symptoms (eg, palpitations). Patients often present with symptom preoccupation in terms of symptom fear, avoidance, and control behaviors. Internet-delivered cognitive behavior therapy is effective for treating other somatic disorders but has never been evaluated in patients with AF. Objective: The aim of this study is to evaluate the efficacy and feasibility of AF-specific internet-delivered cognitive behavior therapy. Methods: We conducted an uncontrolled pilot study in which 19 patients with symptomatic paroxysmal AF underwent internet-delivered cognitive behavior therapy. Participants completed self-assessments at pretreatment, posttreatment, and at a 6-month follow-up along with handheld electrocardiogram measurements with symptom registration. The treatment lasted 10 weeks and included exposure to physical sensations, reduction in avoidance behavior, and behavioral activation. Results: We observed large within-group improvements in the primary outcome, AF-specific QoL (Cohen d=0.80; P<.001), and in symptom preoccupation (Cohen d=1.24; P<.001) at posttreatment; the results were maintained at the 6-month follow-up. Treatment satisfaction and adherence rates were also high. We observed an increased AF burden, measured by electrocardiogram, at the 6-month follow-up, but a significant decrease was observed in the overestimation of AF symptoms at posttreatment and 6-month follow-up. Exploratory mediation analysis showed that a reduction in symptom preoccupation mediated the effects of internet-delivered cognitive behavior therapy on AF-specific QoL. Conclusions: This study presents preliminary evidence for the potential efficacy and feasibility of a novel approach in treating patients with symptomatic AF with internet-delivered cognitive behavior therapy. Trial Registration: ClinicalTrials.gov NCT02694276; https://clinicaltrials.gov/ct2/show/NCT02694276 %M 33650972 %R 10.2196/24524 %U https://cardio.jmir.org/2021/1/e24524 %U https://doi.org/10.2196/24524 %U http://www.ncbi.nlm.nih.gov/pubmed/33650972 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e24134 %T A Novel Mobile App (Heali) for Disease Treatment in Participants With Irritable Bowel Syndrome: Randomized Controlled Pilot Trial %A Rafferty,Aaron J %A Hall,Rick %A Johnston,Carol S %+ College of Health Solutions, Arizona State University, HLTHN 532 Phoenix Downtown Campus, Phoenix, AZ, 85004, United States, 1 602 496 2539, Carol.johnston@asu.edu %K irritable bowel syndrome %K artificial intelligence %K mobile app %K low FODMAP diet %K randomized controlled trial %D 2021 %7 2.3.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: A diet high in fermentable, oligo-, di-, monosaccharides and polyols (FODMAPs) has been shown to exacerbate symptoms of irritable bowel syndrome (IBS). Previous literature reports significant improvement in IBS symptoms with initiation of a low FODMAP diet (LFD) and monitored reintroduction. However, dietary adherence to the LFD is difficult, with patients stating that the information given by health care providers is often generalized and nonspecific, requiring them to search for supplementary information to fit their needs. Objective: The aim of our study was to determine whether Heali, a novel artificial intelligence dietary mobile app can improve adherence to the LFD, IBS symptom severity, and quality of life outcomes in adults with IBS or IBS-like symptoms over a 4-week period. Methods: Participants were randomized into 2 groups: the control group (CON), in which participants received educational materials, and the experimental group (APP), in which participants received access to the mobile app and educational materials. Over the course of this unblinded online trial, all participants completed a battery of 5 questionnaires at baseline and at the end of the trial to document IBS symptoms, quality of life, LFD knowledge, and LFD adherence. Results: We enrolled 58 participants in the study (29 in each group), and 25 participants completed the study in its entirety (11 and 14 for the CON and APP groups, respectively). Final, per-protocol analyses showed greater improvement in quality of life score for the APP group compared to the CON group (31.1 and 11.8, respectively; P=.04). Reduction in total IBS symptom severity score was 24% greater for the APP group versus the CON group. Although this did not achieve significance (–170 vs –138 respectively; P=.37), the reduction in the subscore for bowel habit dissatisfaction was 2-fold greater for the APP group than for the CON group (P=.05). Conclusions: This initial study provides preliminary evidence that Heali may provide therapeutic benefit to its users, specifically improvements in quality of life and bowel habits. Although this study was underpowered, findings from this study warrant further research in a larger sample of participants to test the efficacy of Heali app use to improve outcomes for patients with IBS. Trial Registration: ClinicalTrials.gov NCT04256551; https://clinicaltrials.gov/ct2/show/NCT04256551 %M 33650977 %R 10.2196/24134 %U https://www.jmir.org/2021/3/e24134 %U https://doi.org/10.2196/24134 %U http://www.ncbi.nlm.nih.gov/pubmed/33650977 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 3 %P e13591 %T Web-Based Dietary Intake Estimation to Assess the Reproducibility and Relative Validity of the EatWellQ8 Food Frequency Questionnaire: Validation Study %A Alawadhi,Balqees %A Fallaize,Rosalind %A Franco,Rodrigo Zenun %A Hwang,Faustina %A Lovegrove,Julie %+ Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, Department of Food and Nutritional Sciences, University of Reading, Whiteknights, Reading, RG6 6AP, United Kingdom, 44 0118 378 6418, j.a.lovegrove@reading.ac.uk %K web-based %K Kuwait %K weighed food record %K app %K food frequency questionnaire %K validation %K dietary assessment %D 2021 %7 2.3.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: The web-based EatWellQ8 food frequency questionnaire (FFQ) was developed as a dietary assessment tool for healthy adults in Kuwait. Validation against reliable instruments and assessment of its reproducibility are required to ensure the accuracy of the EatWellQ8 FFQ in computing nutrient intake. Objective: This study aims to assess the reproducibility and relative validity of the EatWellQ8 146-item FFQ, which included images of food portion sizes based on The Composition of Foods by McCance and Widdowson and food composition tables from Kuwait and the Kingdom of Bahrain, against a paper-based FFQ (PFFQ) and a 4-day weighed food record (WFR). Methods: Reproducibility of the EatWellQ8 FFQ was assessed using a test-retest methodology. Participants were required to complete the FFQ at 2 time points, 4 weeks apart. To assess the relative validity of the EatWellQ8 FFQ, a subset of the participants were asked to complete a PFFQ or a 4-day WFR 1 week after the administration of the EatWellQ8 FFQ. The level of agreement between nutrient and food group intakes was estimated by repeated EatWellQ8 FFQ administration. The EatWellQ8 FFQ, PFFQ, and 4-day WFR were also evaluated using the Bland-Altman methodology and classified into quartiles of daily intake. Crude unadjusted correlation coefficients were also calculated for nutrients and food groups. Results: A total of 99 Kuwaiti participants (64/99, 65% female and 35/99, 35% male) completed the study—53 participated in the reproducibility study and the 4-day WFR validity study (mean age 37.1 years, SD 9.9) and 46 participated in the PFFQ validity study (mean age 36.2 years, SD 8.3). Crude unadjusted correlations for repeated EatWellQ8 FFQs ranged from 0.37 to 0.93 (mean r=0.67, SD 0.14; 95% CI 0.11-0.95) for nutrients and food groups (P=.01). Mean cross-classification into exact agreement plus adjacent was 88% for nutrient intakes and 86% for food groups, and Bland-Altman plots showed good agreement for energy-adjusted macronutrient intakes. The association between the EatWellQ8 FFQ and PFFQ varied, with crude unadjusted correlations ranging from 0.42 to 0.73 (mean r=0.46, SD 0.12; 95% CI −0.02 to 0.84; P=.046). Mean cross-classification into exact agreement plus adjacent was 84% for nutrient intake and 74% for food groups. Bland-Altman plots showed moderate agreement for both energy and energy-controlled nutrient intakes. Crude unadjusted correlations for the EatWellQ8 FFQ and the 4-day WFR ranged from 0.40 to 0.88 (mean r=0.58, SD 0.13; 95% CI 0.01-0.58; P=.01). Mean cross-classification into exact agreement plus adjacent was 85% for nutrient intake and 83% for food groups. Bland-Altman plots showed moderate agreement for energy-adjusted macronutrient intakes. Conclusions: The results indicate that the web-based EatWellQ8 FFQ is reproducible for assessing nutrient and food group intake and has moderate agreement compared with a PFFQ and a 4-day WFR for measuring energy and nutrient intakes. %M 33650974 %R 10.2196/13591 %U https://formative.jmir.org/2021/3/e13591 %U https://doi.org/10.2196/13591 %U http://www.ncbi.nlm.nih.gov/pubmed/33650974 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 3 %P e19239 %T Interplay of Support, Comparison, and Surveillance in Social Media Weight Management Interventions: Qualitative Study %A Chang,Leanne %A Chattopadhyay,Kaushik %A Li,Jialin %A Xu,Miao %A Li,Li %+ Department of Endocrinology and Metabolism, Ningbo First Hospital, 59 Liuting Street, Ningbo, Zhejiang 315010, China, 86 574 8708 5588, lilyningbo@163.com %K obesity %K social comparison %K social media %K social support %K surveillance %K weight control %D 2021 %7 1.3.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: There has been a significant increase in the trend of using social media as a platform to deliver weight management interventions. This illustrates a need to develop a holistic understanding of doctor-patient communication and peer-to-peer communication in social media interventions and to determine their influences on weight management for people with overweight or obesity. Such studies will highlight how social media can be more effectively integrated into weight management programs to enhance individuals’ short-term and long-term weight management behaviors. Objective: The aim of this study was to examine patients’ experiences with doctor-patient communication and peer interactions in a social media–based (WeChat) weight management program, and to describe the interplay of three social influence factors—social support, social comparison, and surveillance—in their weight control practices. The program, designed and implemented by the research team located in a tertiary referral hospital in a southeastern province in China, included both diet and physical activity components that targeted people with overweight or obesity. Methods: We conducted in-depth interviews with 32 program participants of different ages (mean 35.6, SD 7.7 years), gender (18 women), duration of program membership (mean 1.4 years), and weight loss outcomes (54% weight loss to 9% weight gain). All interview data were audio-recorded, transcribed, and translated using the translation-backtranslation technique. Nvivo software was used to facilitate the coding process. Results: Results of thematic analysis indicated the distinct functions of professionally led support and peer support. Professional support was presented in the form of knowledge infusion, efficacy enhancement, and provision of timely feedback. Peer support fostered empathy and sense of belonging, and had a mutually reinforcing relationship with peer comparison and peer-based surveillance. Peer comparison enhanced motivation and positive competition. However, it also reinforced negative group norms, and resulted in downturns in reference standards and collective inactivity. Social media surveillance prompted participants’ reactions to the gaze from medical professionals and peers that could be encouraging or inhibiting. Surveillance enhanced vigilance with weight control norms; however, its influence weakened when participants chose to fake weight data and turn off notifications. Findings from this study illustrated the interrelated and fluctuating influences of support, comparison, and surveillance. Conclusions: The interactive traits of social media eased the practices of social support and social comparison, and created new forms of surveillance. This study contributes to an in-depth understanding of social media influences on individuals’ weight control behaviors. Practical implications of the study concern improved strategies for maintaining the positive dynamics of social media interactions and preventing negative resistance to surveillance technology. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900025861; http://www.chictr.org.cn/showprojen.aspx?proj=42497 %M 33646130 %R 10.2196/19239 %U https://mhealth.jmir.org/2021/3/e19239 %U https://doi.org/10.2196/19239 %U http://www.ncbi.nlm.nih.gov/pubmed/33646130 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 3 %P e23022 %T Using a Tablet-Based App to Deliver Evidence-Based Practices for Suicidal Patients in the Emergency Department: Pilot Randomized Controlled Trial %A Dimeff,Linda A %A Jobes,David A %A Koerner,Kelly %A Kako,Nadia %A Jerome,Topher %A Kelley-Brimer,Angela %A Boudreaux,Edwin D %A Beadnell,Blair %A Goering,Paul %A Witterholt,Suzanne %A Melin,Gabrielle %A Samike,Vicki %A Schak,Kathryn M %+ Evidence Based Practice Institute, Inc, 7241 36th Avenue SW, Seattle, WA, 98126, United States, 1 206 284 7371, linda.dimeff@jasprhealth.com %K suicide %K emergency department %K digital technology %K suicide prevention %D 2021 %7 1.3.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: Emergency departments (EDs) have the potential to provide evidence-based practices for suicide prevention to patients who are acutely suicidal. However, few EDs have adequate time and personnel resources to deliver recommended evidence-based assessment and interventions. To raise the clinical standard of care for patients who are suicidal and seeking psychiatric crisis services in the ED, we developed Jaspr Health, a tablet-based app for direct use by such patients, which enables the delivery of 4 evidence-based practices. Objective: This study aims to evaluate the feasibility, acceptability, and effectiveness of Jaspr Health among suicidal adults in EDs. Methods: Patients who were acutely suicidal and seeking psychiatric crisis services participated in an unblinded pilot randomized controlled trial while in the ED. Participants were randomly assigned to Jaspr Health (n=14) or care as usual (control; n=17) groups. Participants were assessed at baseline, and a 2-hour posttest using self-report measures and a semistructured interview were conducted. Results: Conditions differed significantly at baseline with regard to age but not other demographic variables or baseline measures. On average, participants had been in the ED for 17 hours before enrolling in the study. Over their lifetime, 84% (26/31) of the sample had made a suicide attempt (mean 3.4, SD 6.4) and 61% (19/31) had engaged in nonsuicidal self-injurious behaviors, with an average rate of 8.8 times in the past 3 months. All established feasibility and acceptability criteria were met: no adverse events occurred, participants’ app use was high, Jaspr Health app user satisfaction ratings were high, and all participants using Jaspr Health recommended its use for other suicidal ED patients. Comparisons between study conditions provide preliminary support for the effectiveness of the app: participants using Jaspr Health reported a statistically significant increase in receiving 4 evidence-based suicide prevention interventions and overall satisfaction ratings with their ED experience. In addition, significant decreases in distress and agitation, along with significant increases in learning to cope more effectively with current and future suicidal thoughts, were observed among participants using Jaspr Health compared with those receiving care as usual. Conclusions: Even with limited statistical power, the results showed that Jaspr Health is feasible, acceptable, and clinically effective for use by ED patients who are acutely suicidal and seeking ED-based psychiatric crisis services. Trial Registration: ClinicalTrials.gov NCT03584386; https://clinicaltrials.gov/ct2/show/NCT03584386 %M 33646129 %R 10.2196/23022 %U https://mental.jmir.org/2021/3/e23022 %U https://doi.org/10.2196/23022 %U http://www.ncbi.nlm.nih.gov/pubmed/33646129 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 2 %P e22197 %T Infection Control Behavior at Home During the COVID-19 Pandemic: Observational Study of a Web-Based Behavioral Intervention (Germ Defence) %A Ainsworth,Ben %A Miller,Sascha %A Denison-Day,James %A Stuart,Beth %A Groot,Julia %A Rice,Cathy %A Bostock,Jennifer %A Hu,Xiao-Yang %A Morton,Katherine %A Towler,Lauren %A Moore,Michael %A Willcox,Merlin %A Chadborn,Tim %A Gold,Natalie %A Amlôt,Richard %A Little,Paul %A Yardley,Lucy %+ Department of Psychology, University of Bath, Claverton Down, Bath, BA27AY, United Kingdom, 44 01225388388, ba548@bath.ac.uk %K COVID-19 %K novel coronavirus %K behavior change %K digital medicine %K infection control %K infectious disease %K protection %K digital health %D 2021 %7 25.2.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: To control the COVID-19 pandemic, people should adopt protective behaviors at home (self-isolation, social distancing, putting shopping and packages aside, wearing face coverings, cleaning and disinfecting, and handwashing). There is currently limited support to help individuals conduct these behaviors. Objective: This study aims to report current household infection control behaviors in the United Kingdom and examine how they might be improved. Methods: This was a pragmatic cross-sectional observational study of anonymous participant data from Germ Defence between May 6-24, 2020. Germ Defence is an open-access fully automated website providing behavioral advice for infection control within households. A total of 28,285 users sought advice from four website pathways based on household status (advice to protect themselves generally, to protect others if the user was showing symptoms, to protect themselves if household members were showing symptoms, and to protect a household member who is at high risk). Users reported current infection control behaviors within the home and intentions to change these behaviors. Results: Current behaviors varied across all infection control measures but were between sometimes (face covering: mean 1.61, SD 1.19; social distancing: mean 2.40, SD 1.22; isolating: mean 2.78, SD 1.29; putting packages and shopping aside: mean 2.75, SD 1.55) and quite often (cleaning and disinfecting: mean 3.17, SD 1.18), except for handwashing (very often: mean 4.00, SD 1.03). Behaviors were similar regardless of the website pathway used. After using Germ Defence, users recorded intentions to improve infection control behavior across all website pathways and for all behaviors (overall average infection control score mean difference 0.30, 95% CI 0.29-0.31). Conclusions: Self-reported infection control behaviors other than handwashing are lower than is optimal for infection prevention, although handwashing is much higher. Advice using behavior change techniques in Germ Defence led to intentions to improve these behaviors. Promoting Germ Defence within national and local public health and primary care guidance could reduce COVID-19 transmission. %M 33566791 %R 10.2196/22197 %U https://www.jmir.org/2021/2/e22197 %U https://doi.org/10.2196/22197 %U http://www.ncbi.nlm.nih.gov/pubmed/33566791 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 7 %N 2 %P e18487 %T Evaluating the Effectiveness of a Web-Based Program (POP4Teens) to Prevent Prescription Opioid Misuse Among Adolescents: Randomized Controlled Trial %A Marsch,Lisa A %A Moore,Sarah K %A Grabinski,Michael %A Bessen,Sarah Y %A Borodovsky,Jacob %A Scherer,Emily %+ Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth College, 46 Centerra Pkwy, Lebanon, NH, 03766, United States, 1 9176789280, sarah.k.moore@dartmouth.edu %K opioids %K prevention and control %K adolescent %K randomized controlled trial %K internet %D 2021 %7 25.2.2021 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: Prescription opioid (PO) use is common among adolescents in the United States. Despite recent declines from unprecedented peaks in adolescent PO use (eg, in 2012-2013), there is seemingly paradoxical evidence that PO-related consequences (eg, opioid use disorder and overdoses) are increasing. These trends and their possible consequences emphasize the importance of prevention efforts targeting PO misuse. To our knowledge, we have developed the first interactive web-based program (POP4Teens [P4T]) focused specifically on the prevention of PO misuse among adolescents. Objective: This study aimed to evaluate the effectiveness of P4T, a web-based program designed to prevent adolescent PO misuse, in comparison with JustThinkTwice (JTT), an active control website, on PO-related attitudes, knowledge, risk perception, and intentions to use. Methods: We conducted a web-based randomized controlled trial in 2018. A total of 406 adolescents (aged 12-17 years) were randomly assigned to either P4T or JTT. The outcome variables were attitudes, knowledge, and risk perceptions associated with PO misuse, intentions to use POs, and program feedback. Data were collected at baseline and at 1, 3, and 6 months. Results: Both programs resulted in significant and sustained improvements in intention to use POs, increased perceived risk, impacted expectancies consistent with prevention, and improved PO refusal skills. P4T produced significantly greater increases in PO-related knowledge than JTT did, and it was reportedly easier to use and more liked. Baseline scores for youth reporting past-year medical use of POs, friends who engage in nonmedical use of POs, and/or poor mental health underscored their at-risk status compared with youth from the other groups. Conclusions: P4T positively impacted all study variables that are known to prevent PO misuse among teens. Moreover, its web-based nature simplifies the dissemination and implementation of this novel tool designed to help meet the challenges of the evolving national opioid crisis. Trial Registration: ClinicalTrials.gov NCT02737696; https://clinicaltrials.gov/ct2/show/NCT02737696 %M 33629961 %R 10.2196/18487 %U https://publichealth.jmir.org/2021/2/e18487 %U https://doi.org/10.2196/18487 %U http://www.ncbi.nlm.nih.gov/pubmed/33629961 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 2 %P e15946 %T Development and Feasibility of a Web-Based Decision Aid for Patients With Ulcerative Colitis: Qualitative Pilot Study %A Kim,Andrew H %A Girgis,Afaf %A De Cruz,Peter %A Siegel,Corey A %A Karimi,Neda %A Ruban,Sasha O %A Sechi,Alexandra J %A Ng,Wa Sang Watson %A Andrews,Jane M %A Connor,Susan J %+ Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, The University of New South Wales, Department of Gastroenterology Liverpool Hospital, Sydney, Australia, 61 2 8738 4085, Susan.Connor1@health.nsw.gov.au %K shared decision making %K decision aid %K ulcerative colitis %D 2021 %7 25.2.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Shared decision making (SDM) is becoming an important part of ulcerative colitis (UC) management because of the increasing complexity of available treatment choices and their trade-offs. The use of decision aids (DA) may be effective in increasing patients’ participation in UC management but their uptake has been limited due to high attrition rates and lack of a participatory approach to their design and implementation. Objective: The primary aim of this study is to explore the perspectives of Australian patients and their clinicians regarding the feasibility and acceptability of myAID, a web-based DA, in informing treatment decisions in UC. The secondary aim is to use the findings of this pilot study to inform the design of a cluster randomized clinical trial (CRCT) to assess the efficacy of the DA compared with usual care. Methods: myAID, a DA was designed and developed using a participatory approach by a multidisciplinary team of clinicians, patients, and nonmedical volunteers. A qualitative pilot study to evaluate the DA, involving patients with UC facing new treatment decisions and inflammatory bowel disease clinicians, was undertaken. Results: A total of 11 patients with UC and 15 clinicians provided feedback on myAID. Themes explored included the following: Acceptability and usability of myAID—myAID was found to be acceptable by the majority of clinicians as a tool to facilitate SDM, uptake was thought to vary depending on clinicians’ approaches to patient education and practice, potential to overcome time restrictions associated with outpatient clinics was identified, presentation of unbiased information enabling patients to digest information at their own pace was noted, and potential to provoke anxiety among patients with a new diagnosis or mild disease was raised; Perceived role and usefulness of myAID—discordance was observed between patients who prioritized voicing preferences and clinicians who prioritized treatment adherence, and myAID facilitated early discussion of medical versus surgical treatment options; Target population and timing of use—greatest benefit was perceived at the time of initiating or changing treatment and following commencement of immunosuppressive therapy; and Potential concerns and areas for improvement—some perceived that use of myAID may precipitate anxiety by increasing decisional conflict and impact the therapeutic relationship between patient and the clinician and may increase resource requirements. Conclusions: These preliminary findings suggest that patients and clinicians consider myAID as a feasible and acceptable tool to facilitate SDM for UC management. These pilot data have informed a participatory approach to the design of a CRCT, which will evaluate the clinical efficacy of myAID compared with usual care. Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12617001246370; http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617001246370. %M 33629956 %R 10.2196/15946 %U https://www.jmir.org/2021/2/e15946 %U https://doi.org/10.2196/15946 %U http://www.ncbi.nlm.nih.gov/pubmed/33629956 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 2 %P e17573 %T A Novel User Utility Score for Diabetes Management Using Tailored Mobile Coaching: Secondary Analysis of a Randomized Controlled Trial %A Lee,Min-Kyung %A Lee,Da Young %A Ahn,Hong-Yup %A Park,Cheol-Young %+ Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea, 82 2 2001 1869, cydoctor@chol.com %K type 2 diabetes %K mobile applications %K diabetes management %K patient engagement %D 2021 %7 24.2.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mobile health applications have been developed to support diabetes self-management, but their effectiveness could depend on patient engagement. Therefore, patient engagement must be examined through multifactorial tailored behavioral interventions from an individual perspective. Objective: This study aims to evaluate the usefulness of a novel user utility score (UUS) as a tool to measure patient engagement by using a mobile health application for diabetes management. Methods: We conducted a subanalysis of results from a 12-month randomized controlled trial of a tailored mobile coaching (TMC) system among insurance policyholders with type 2 diabetes. UUS was calculated as the sum of the scores for 4 major core components (range 0-8): frequency of self-monitoring blood glucose testing, dietary and exercise records, and message reading rate. We explored the association between UUS for the first 3 months and glycemic control over 12 months. In addition, we investigated the relationship of UUS with blood pressure, lipid profile, and self-report scales assessing diabetes self-management. Results: We divided 72 participants into 2 groups based on UUS for the first 3 months: UUS:0-4 (n=38) and UUS:5-8 (n=34). There was a significant between-group difference in glycated hemoglobin test (HbA1c) levels for the 12-months study period (P=.011). The HbA1c decrement at 12 months in the UUS:5-8 group was greater than that of the UUS:0-4 group [–0.92 (SD 1.24%) vs –0.33 (SD 0.80%); P=.049]. After adjusting for confounding factors, UUS was significantly associated with changes in HbA1c at 3, 6, and 12 months; the regression coefficients were –0.113 (SD 0.040; P=.006), –0.143 (SD 0.045; P=.002), and –0.136 (SD 0.052; P=.011), respectively. Change differences in other health outcomes between the 2 groups were not observed throughout a 12-month follow-up. Conclusions: UUS as a measure of patient engagement was associated with changes in HbA1c over the study period of the TMC system and could be used to predict improved glycemic control in diabetes self-management through mobile health interventions. Trial Registration: ClinicalTrial.gov NCT03033407; https://clinicaltrials.gov/ct2/show/NCT03033407 %M 33625363 %R 10.2196/17573 %U https://mhealth.jmir.org/2021/2/e17573 %U https://doi.org/10.2196/17573 %U http://www.ncbi.nlm.nih.gov/pubmed/33625363 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 2 %P e20445 %T Effects of Smartphone-Based Stress Management on Improving Work Engagement Among Nurses in Vietnam: Secondary Analysis of a Three-Arm Randomized Controlled Trial %A Sasaki,Natsu %A Imamura,Kotaro %A Tran,Thuy Thi Thu %A Nguyen,Huong Thanh %A Kuribayashi,Kazuto %A Sakuraya,Asuka %A Bui,Thu Minh %A Nguyen,Quynh Thuy %A Nguyen,Nga Thi %A Nguyen,Giang Thi Huong %A Zhang,Melvyn Weibin %A Minas,Harry %A Sekiya,Yuki %A Watanabe,Kazuhiro %A Tsutsumi,Akizumi %A Shimazu,Akihito %A Kawakami,Norito %+ Department of Mental Health, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, , Japan, 81 3 5841 3522, nkawakami@m.u-tokyo.ac.jp %K stress management %K mental health %K occupational health %K digital health %K workplace %K LMICs %K South-East Asia %K health care professionals %D 2021 %7 23.2.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Work engagement is important for employee well-being and work performance. However, no intervention study has investigated the effect of an eMental Health intervention on work engagement among workers in low- and middle-income countries (LMICs). Objective: The aim of the study was to examine the effects of a newly developed smartphone-based stress management program (ABC Stress Management) on improving work engagement among hospital nurses in Vietnam, an LMIC. Methods: Full-time registered nurses (n=949) were randomly assigned to one of 2 intervention groups or a control group. The intervention groups were a 6-week, 6-lesson program offering basic cognitive behavioral therapy (CBT-based stress management skills), provided in either free-choice (program A) or fixed order (program B). Work engagement was assessed at baseline and 3-month and 7-month follow-ups in each of the 3 groups. Results: The scores of work engagement in both intervention groups improved from baseline to 3-month follow-up, and then decreased at the 7-month follow-up, while the score steadily increased from baseline to 7-month follow-up in the control group. Program B showed a significant intervention effect on improving work engagement at the 3-month follow-up (P=.049) with a small effect size (Cohen d= 0.16; 95% CI 0.001 to 0.43]). Program A showed nonsignificant trend (d=0.13; 95% CI –0.014 to 0.41; P=.07) toward improved engagement at 3 months. Neither program achieved effectiveness at the 7-month follow-up. Conclusions: The study demonstrated that a fixed order (program B) delivery of a smartphone-based stress management program was effective in improving work engagement in nurses in Vietnam. However, the effect was small and only temporary. Further improvement of this program is required to achieve a greater effect size and more sustained, longer lasting impact on work engagement. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000033139; tinyurl.com/55gxo253 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2018-025138 %M 33620328 %R 10.2196/20445 %U https://www.jmir.org/2021/2/e20445 %U https://doi.org/10.2196/20445 %U http://www.ncbi.nlm.nih.gov/pubmed/33620328 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 2 %P e18524 %T A Web-Based Computer-Tailored Program to Improve Treatment Adherence in Patients With Type 2 Diabetes: Randomized Controlled Trial %A Vluggen,Stan %A Candel,Math %A Hoving,Ciska %A Schaper,Nicolaas C %A de Vries,Hein %+ Department of Health Promotion, Maastricht University, P. Debyeplein 1, Maastricht, 6229 HA, Netherlands, 31 043 3881557, stan.vluggen@maastrichtuniversity.nl %K type 2 diabetes mellitus %K treatment adherence %K eHealth %K computer-tailoring %K randomized controlled trial %D 2021 %7 23.2.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Adherence to core type 2 diabetes mellitus (T2DM) treatment behaviors is suboptimal, and nonadherence is generally not limited to one treatment behavior. The internet holds promise for programs that aim to improve adherence. We developed a computer-tailored eHealth program for patients with T2DM to improve their treatment adherence, that is, adherence to both a healthy lifestyle and medical behaviors. Objective: The objective of this study is to examine the effectiveness of the eHealth program in a randomized controlled trial. Methods: Patients with T2DM were recruited by their health professionals and randomized into either the intervention group, that is, access to the eHealth program for 6 months, or a waiting-list control group. In total, 478 participants completed the baseline questionnaire, of which 234 gained access to the eHealth program. Of the 478 participants, 323 were male and 155 were female, the mean age was 60 years, and the participants had unfavorable BMI and HbA1c levels on average. Outcome data were collected through web-based assessments on physical activity (PA) levels, caloric intake from unhealthy snacks, and adherence to oral hypoglycemic agents (OHAs) and insulin therapy. Changes to separate behaviors were standardized and summed into a composite change score representing changes in the overall treatment adherence. Further standardization of this composite change score yielded the primary outcome, which can be interpreted as Cohen d (effect size). Standardized change scores observed in separate behaviors acted as secondary outcomes. Mixed linear regression analyses were conducted to examine the effectiveness of the intervention on overall and separate treatment behavior adherence, accommodating relevant covariates and patient nesting. Results: After the 6-month follow-up assessment, 47.4% (111/234) of participants in the intervention group and 72.5% (177/244) of participants in the control group were retained. The overall treatment adherence improved significantly in the intervention group compared with the control group, reflected by a small effect size (d=0.27; 95% CI 0.032 to 0.509; P=.03). When considering changes in separate treatment behaviors, a significant decrease was observed only in caloric intake from unhealthy snacks in comparison with the control group (d=0.36; 95% CI 0.136 to 0.584; P=.002). For adherence to PA (d=−0.14; 95% CI −0.388 to 0.109; P=.27), OHAs (d=0.27; 95% CI −0.027 to 0.457; P=.08), and insulin therapy (d=0.35; 95% CI −0.066 to 0.773; P=.10), no significant changes were observed. These results from the unadjusted analyses were comparable with the results of the adjusted analyses, the per-protocol analyses, and the sensitivity analyses. Conclusions: Our multibehavior program significantly improved the overall treatment adherence compared with the control group. To further enhance the impact of the intervention in the personal, societal, and economic areas, a wide-scale implementation of our eHealth intervention is suggested. Trial Registration: Netherlands Trial Register NL664; https://www.trialregister.nl/trial/6664 %M 33620321 %R 10.2196/18524 %U https://www.jmir.org/2021/2/e18524 %U https://doi.org/10.2196/18524 %U http://www.ncbi.nlm.nih.gov/pubmed/33620321 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 2 %P e26292 %T An 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality Program for Chronic Low Back Pain: Double-Blind, Randomized, Placebo-Controlled Trial Conducted During COVID-19 %A Garcia,Laura M %A Birckhead,Brandon J %A Krishnamurthy,Parthasarathy %A Sackman,Josh %A Mackey,Ian G %A Louis,Robert G %A Salmasi,Vafi %A Maddox,Todd %A Darnall,Beth D %+ Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, 1070 Arastradero Road, Ste 200, MC5596, Palo Alto, CA, 94304, United States, 1 15035778377, bdarnall@stanford.edu %K virtual reality %K low back pain %K opioids %K chronic pain %K behavioral health %K pain treatment, randomized controlled trial %K COVID-19 %D 2021 %7 22.2.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic low back pain is the most prevalent chronic pain condition worldwide and access to behavioral pain treatment is limited. Virtual reality (VR) is an immersive technology that may provide effective behavioral therapeutics for chronic pain. Objective: We aimed to conduct a double-blind, parallel-arm, single-cohort, remote, randomized placebo-controlled trial for a self-administered behavioral skills-based VR program in community-based individuals with self-reported chronic low back pain during the COVID-19 pandemic. Methods: A national online convenience sample of individuals with self-reported nonmalignant low back pain with duration of 6 months or more and with average pain intensity of 4 or more/10 was enrolled and randomized 1:1 to 1 of 2 daily (56-day) VR programs: (1) EaseVRx (immersive pain relief skills VR program); or (2) Sham VR (2D nature content delivered in a VR headset). Objective device use data and self-reported data were collected. The primary outcomes were the between-group effect of EaseVRx versus Sham VR across time points, and the between–within interaction effect representing the change in average pain intensity and pain-related interference with activity, stress, mood, and sleep over time (baseline to end-of-treatment at day 56). Secondary outcomes were global impression of change and change in physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, pain medication use, and user satisfaction. Analytic methods included intention-to-treat and a mixed-model framework. Results: The study sample was 179 adults (female: 76.5%, 137/179; Caucasian: 90.5%, 162/179; at least some college education: 91.1%, 163/179; mean age: 51.5 years [SD 13.1]; average pain intensity: 5/10 [SD 1.2]; back pain duration ≥5 years: 67%, 120/179). No group differences were found for any baseline variable or treatment engagement. User satisfaction ratings were higher for EaseVRx versus Sham VR (P<.001). For the between-groups factor, EaseVRx was superior to Sham VR for all primary outcomes (highest P value=.009), and between-groups Cohen d effect sizes ranged from 0.40 to 0.49, indicating superiority was moderately clinically meaningful. For EaseVRx, large pre–post effect sizes ranged from 1.17 to 1.3 and met moderate to substantial clinical importance for reduced pain intensity and pain-related interference with activity, mood, and stress. Between-group comparisons for Physical Function and Sleep Disturbance showed superiority for the EaseVRx group versus the Sham VR group (P=.022 and .013, respectively). Pain catastrophizing, pain self-efficacy, pain acceptance, prescription opioid use (morphine milligram equivalent) did not reach statistical significance for either group. Use of over-the-counter analgesic use was reduced for EaseVRx (P<.01) but not for Sham VR. Conclusions: EaseVRx had high user satisfaction and superior and clinically meaningful symptom reduction for average pain intensity and pain-related interference with activity, mood, and stress compared to sham VR. Additional research is needed to determine durability of treatment effects and to characterize mechanisms of treatment effects. Home-based VR may expand access to effective and on-demand nonpharmacologic treatment for chronic low back pain. Trial Registration: ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177 International Registered Report Identifier (IRRID): RR2-10.2196/25291 %M 33484240 %R 10.2196/26292 %U https://www.jmir.org/2021/2/e26292 %U https://doi.org/10.2196/26292 %U http://www.ncbi.nlm.nih.gov/pubmed/33484240 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 2 %P e23612 %T Hybrid Ubiquitous Coaching With a Novel Combination of Mobile and Holographic Conversational Agents Targeting Adherence to Home Exercises: Four Design and Evaluation Studies %A Kowatsch,Tobias %A Lohse,Kim-Morgaine %A Erb,Valérie %A Schittenhelm,Leo %A Galliker,Helen %A Lehner,Rea %A Huang,Elaine M %+ Centre for Digital Health Interventions, Department of Management, Technology, and Economics, ETH Zurich, WEV-G, Weinbergstrasse 56/58, Zurich, 8092, Switzerland, 41 712247244, tkowatsch@ethz.ch %K ubiquitous coaching %K augmented reality %K health care %K treatment adherence %K design science research %K physiotherapy %K chronic back pain %K pain %K chronic pain %K exercise %K adherence %K treatment %K conversational agent %K smartphone %K mobile phone %D 2021 %7 22.2.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Effective treatments for various conditions such as obesity, cardiac heart diseases, or low back pain require not only personal on-site coaching sessions by health care experts but also a significant amount of home exercises. However, nonadherence to home exercises is still a serious problem as it leads to increased costs due to prolonged treatments. Objective: To improve adherence to home exercises, we propose, implement, and assess the novel coaching concept of hybrid ubiquitous coaching (HUC). In HUC, health care experts are complemented by a conversational agent (CA) that delivers psychoeducation and personalized motivational messages via a smartphone, as well as real-time exercise support, monitoring, and feedback in a hands-free augmented reality environment. Methods: We applied HUC to the field of physiotherapy and conducted 4 design-and-evaluate loops with an interdisciplinary team to assess how HUC is perceived by patients and physiotherapists and whether HUC leads to treatment adherence. A first version of HUC was evaluated by 35 physiotherapy patients in a lab setting to identify patients’ perceptions of HUC. In addition, 11 physiotherapists were interviewed about HUC and assessed whether the CA could help them build up a working alliance with their patients. A second version was then tested by 15 patients in a within-subject experiment to identify the ability of HUC to address adherence and to build a working alliance between the patient and the CA. Finally, a 4-week n-of-1 trial was conducted with 1 patient to show one experience with HUC in depth and thereby potentially reveal real-world benefits and challenges. Results: Patients perceived HUC to be useful, easy to use, and enjoyable, preferred it to state-of-the-art approaches, and expressed their intentions to use it. Moreover, patients built a working alliance with the CA. Physiotherapists saw a relative advantage of HUC compared to current approaches but initially did not see the potential in terms of a working alliance, which changed after seeing the results of HUC in the field. Qualitative feedback from patients indicated that they enjoyed doing the exercise with an augmented reality–based CA and understood better how to do the exercise correctly with HUC. Moreover, physiotherapists highlighted that HUC would be helpful to use in the therapy process. The longitudinal field study resulted in an adherence rate of 92% (11/12 sessions; 330/360 repetitions; 33/36 sets) and a substantial increase in exercise accuracy during the 4 weeks. Conclusions: The overall positive assessments from both patients and health care experts suggest that HUC is a promising tool to be applied in various disorders with a relevant set of home exercises. Future research, however, must implement a variety of exercises and test HUC with patients suffering from different disorders. %M 33461957 %R 10.2196/23612 %U https://www.jmir.org/2021/2/e23612 %U https://doi.org/10.2196/23612 %U http://www.ncbi.nlm.nih.gov/pubmed/33461957 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 1 %P e25295 %T Early Insights From a Digitally Enhanced Diabetes Self-Management Education and Support Program: Single-Arm Nonrandomized Trial %A Wilson-Anumudu,Folasade %A Quan,Ryan %A Castro Sweet,Cynthia %A Cerrada,Christian %A Juusola,Jessie %A Turken,Michael %A Bradner Jasik,Carolyn %+ Omada Health, Inc, 500 Sansome Street, Suite 200, San Francisco, CA, 94111, United States, 1 6502696532, folasade.anumudu@omadahealth.com %K diabetes education %K digital health %K remote monitoring %K type 2 diabetes %D 2021 %7 22.2.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Translation of diabetes self-management education and support (DSMES) into a digital format can improve access, but few digital programs have demonstrated outcomes using rigorous evaluation metrics. Objective: The aim of this study was to evaluate the impact of a digital DSMES program on hemoglobin A1c (HbA1c) for people with type 2 diabetes. Methods: A single-arm, nonrandomized trial was performed to evaluate a digital DSMES program that includes remote monitoring and lifestyle change, in addition to comprehensive diabetes education staffed by a diabetes specialist. A sample of 195 participants were recruited using an online research platform (Achievement Studies, Evidation Health Inc). The primary outcome was change in laboratory-tested HbA1c from baseline to 4 months, and secondary outcomes included change in lipids, diabetes distress, and medication adherence. Results: At baseline, participants had a mean HbA1c of 8.9% (SD 1.9) and mean BMI of 37.5 kg/m2 (SD 8.3). The average age was 45.1 years (SD 8.9), 70% were women, and 67% were White. At 4-month follow up, the HbA1c decreased by 0.8% (P<.001, 95% CI –1.1 to –0.5) for the total population and decreased by 1.4% (P<.001, 95% CI –1.8 to –0.9) for those with an HbA1c of >9.0% at baseline. Diabetes distress and medication adherence were also significantly improved between baseline and follow up. Conclusions: This study provides early evidence that a digitally enhanced DSMES program improves HbA1c and disease self-management outcomes. %M 33616533 %R 10.2196/25295 %U https://diabetes.jmir.org/2021/1/e25295 %U https://doi.org/10.2196/25295 %U http://www.ncbi.nlm.nih.gov/pubmed/33616533 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 2 %P e23786 %T Effects of eHealth-Based Multiple Health Behavior Change Interventions on Physical Activity, Healthy Diet, and Weight in People With Noncommunicable Diseases: Systematic Review and Meta-analysis %A Duan,Yanping %A Shang,Borui %A Liang,Wei %A Du,Gaohui %A Yang,Min %A Rhodes,Ryan E %+ Department of Social Sciences, Hebei Sport University, 82 Xuefu Road, Shijiazhuang, 050041, China, 86 15383112089, borui_shang_pe@qq.com %K systematic review %K meta-analysis %K noncommunicable disease %K multiple health behavior change %K weight-related %K physical activity %K healthy diet %K eHealth %D 2021 %7 22.2.2021 %9 Review %J J Med Internet Res %G English %X Background: Noncommunicable diseases (NCDs) are associated with the burden of premature deaths and huge medical costs globally. There is an increasing number of studies combining a multiple health behavior change (MHBC) intervention paradigm with eHealth approaches to jointly promote weight-related health behaviors among people with NCD; yet, a comprehensive summary of these studies is lacking. Objective: This review aims to meta-analyze the effectiveness and systematically summarize the characteristics of the relevant intervention studies for improving the outcomes of physical activity, healthy diet, and weight among people with NCD. Methods: Following PRISMA guidelines, 4 electronic databases (PsycINFO, PubMed, Scopus, SPORTDiscus) were systematically searched to identify eligible articles based on a series of inclusion and exclusion criteria. Article selection, quality assessment, and data extraction were independently performed by 2 authors. The standardized mean difference (SMD) was calculated to evaluate the effectiveness of interventions for 3 intervention outcomes (physical activity, healthy diet, and weight), and subsequent subgroup analyses were performed for gender, age, intervention duration, channel, and theory. Calculations were conducted, and figures were produced in SPSS 22 and Review Manager 5.3. Results: Of the 664 original hits generated by the systematic searches, 15 eligible studies with moderate to high quality were included. No potential publication bias was detected using statistical analyses. Studies varied in intervention channel, intensity, and content. The meta-analysis revealed that the eHealth MHBC interventions significantly promoted physical activity (SMD 0.85, 95% CI 0.23 to 1.47, P=.008) and healthy diet (SMD 0.78, 95% CI 0.13 to 1.43, P=.02), but did not contribute to a healthy weight status (SMD –0.13, 95% CI= –0.47 to 0.20, P=.43) among people with NCDs, compared to the control conditions. Results from subgroup analysis indicated that theory-based interventions achieved greater effect than nontheory-based interventions in promoting physical activity, and interventions with traditional approaches (SMS, telephone) were more effective than those with modern internet-based approaches in promoting healthy diet. Conclusions: The results of this review indicates that eHealth MHBC interventions achieve preliminary success in promoting physical activity and healthy diet behaviors among people with NCD. Future studies could improve the intervention design to achieve better intervention effectiveness. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42019118629; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=118629 %M 33616534 %R 10.2196/23786 %U https://www.jmir.org/2021/2/e23786 %U https://doi.org/10.2196/23786 %U http://www.ncbi.nlm.nih.gov/pubmed/33616534 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 2 %P e23180 %T Associations Between Digital Health Intervention Engagement, Physical Activity, and Sedentary Behavior: Systematic Review and Meta-analysis %A Mclaughlin,Matthew %A Delaney,Tessa %A Hall,Alix %A Byaruhanga,Judith %A Mackie,Paul %A Grady,Alice %A Reilly,Kathryn %A Campbell,Elizabeth %A Sutherland,Rachel %A Wiggers,John %A Wolfenden,Luke %+ School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, 2308, Australia, 61 02 4924 6477, Matthew.Mclaughlin1@health.nsw.gov.au %K engagement %K adherence %K digital health intervention %K digital behavior change intervention %K physical activity %K sedentary behavior %K mobile phone %D 2021 %7 19.2.2021 %9 Review %J J Med Internet Res %G English %X Background: The effectiveness of digital health interventions is commonly assumed to be related to the level of user engagement with the digital health intervention, including measures of both digital health intervention use and users’ subjective experience. However, little is known about the relationships between the measures of digital health intervention engagement and physical activity or sedentary behavior. Objective: This study aims to describe the direction and strength of the association between engagement with digital health interventions and physical activity or sedentary behavior in adults and explore whether the direction of association of digital health intervention engagement with physical activity or sedentary behavior varies with the type of engagement with the digital health intervention (ie, subjective experience, activities completed, time, and logins). Methods: Four databases were searched from inception to December 2019. Grey literature and reference lists of key systematic reviews and journals were also searched. Studies were eligible for inclusion if they examined a quantitative association between a measure of engagement with a digital health intervention targeting physical activity and a measure of physical activity or sedentary behavior in adults (aged ≥18 years). Studies that purposely sampled or recruited individuals on the basis of pre-existing health-related conditions were excluded. In addition, studies were excluded if the individual engaging with the digital health intervention was not the target of the physical activity intervention, the study had a non–digital health intervention component, or the digital health interventions targeted multiple health behaviors. A random effects meta-analysis and direction of association vote counting (for studies not included in meta-analysis) were used to address objective 1. Objective 2 used vote counting on the direction of the association. Results: Overall, 10,653 unique citations were identified and 375 full texts were reviewed. Of these, 19 studies (26 associations) were included in the review, with no studies reporting a measure of sedentary behavior. A meta-analysis of 11 studies indicated a small statistically significant positive association between digital health engagement (based on all usage measures) and physical activity (0.08, 95% CI 0.01-0.14, SD 0.11). Heterogeneity was high, with 77% of the variation in the point estimates explained by the between-study heterogeneity. Vote counting indicated that the relationship between physical activity and digital health intervention engagement was consistently positive for three measures: subjective experience measures (2 of 3 associations), activities completed (5 of 8 associations), and logins (6 of 10 associations). However, the direction of associations between physical activity and time-based measures of usage (time spent using the intervention) were mixed (2 of 5 associations supported the hypothesis, 2 were inconclusive, and 1 rejected the hypothesis). Conclusions: The findings indicate a weak but consistent positive association between engagement with a physical activity digital health intervention and physical activity outcomes. No studies have targeted sedentary behavior outcomes. The findings were consistent across most constructs of engagement; however, the associations were weak. %M 33605897 %R 10.2196/23180 %U http://www.jmir.org/2021/2/e23180/ %U https://doi.org/10.2196/23180 %U http://www.ncbi.nlm.nih.gov/pubmed/33605897 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 2 %P e25175 %T A Web-Based eHealth Intervention to Improve the Quality of Life of Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Controlled Trial %A Gustafson Sr,David H %A Mares,Marie-Louise %A Johnston,Darcie C %A Mahoney,Jane E %A Brown,Randall T %A Landucci,Gina %A Pe-Romashko,Klaren %A Cody,Olivia J %A Gustafson Jr,David H %A Shah,Dhavan V %+ Center for Health Enhancement Systems Studies, University of Wisconsin–Madison, Mechanical Engineering, 4th Fl, 1513 University Avenue, Madison, WI, 53706, United States, 1 608 890 2615, dcjohnston@wisc.edu %K eHealth %K telemedicine %K aged %K geriatrics %K multiple chronic conditions %K depression %K social support %K quality of life %K primary care %K health expenditures %K mobile phone %D 2021 %7 19.2.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Multiple chronic conditions (MCCs) are common among older adults and expensive to manage. Two-thirds of Medicare beneficiaries have multiple conditions (eg, diabetes and osteoarthritis) and account for more than 90% of Medicare spending. Patients with MCCs also experience lower quality of life and worse medical and psychiatric outcomes than patients without MCCs. In primary care settings, where MCCs are generally treated, care often focuses on laboratory results and medication management, and not quality of life, due in part to time constraints. eHealth systems, which have been shown to improve multiple outcomes, may be able to fill the gap, supplementing primary care and improving these patients’ lives. Objective: This study aims to assess the effects of ElderTree (ET), an eHealth intervention for older adults with MCCs, on quality of life and related measures. Methods: In this unblinded study, 346 adults aged 65 years and older with at least 3 of 5 targeted high-risk chronic conditions (hypertension, hyperlipidemia, diabetes, osteoarthritis, and BMI ≥30 kg/m2) were recruited from primary care clinics and randomized in a ratio of 1:1 to one of 2 conditions: usual care (UC) plus laptop computer, internet service, and ET or a control consisting of UC plus laptop and internet but no ET. Patients with ET have access for 12 months and will be followed up for an additional 6 months, for a total of 18 months. The primary outcomes of this study are the differences between the 2 groups with regard to measures of quality of life, psychological well-being, and loneliness. The secondary outcomes are between-group differences in laboratory scores, falls, symptom distress, medication adherence, and crisis and long-term health care use. We will also examine the mediators and moderators of the effects of ET. At baseline and months 6, 12, and 18, patients complete written surveys comprising validated scales selected for good psychometric properties with similar populations; laboratory data are collected from eHealth records; health care use and chronic conditions are collected from health records and patient surveys; and ET use data are collected continuously in system logs. We will use general linear models and linear mixed models to evaluate primary and secondary outcomes over time, with treatment condition as a between-subjects factor. Separate analyses will be conducted for outcomes that are noncontinuous or not correlated with other outcomes. Results: Recruitment was conducted from January 2018 to December 2019, and 346 participants were recruited. The intervention period will end in June 2021. Conclusions: With self-management and motivational strategies, health tracking, educational tools, and peer community and support, ET may help improve outcomes for patients coping with ongoing, complex MCCs. In addition, it may relieve some stress on the primary care system, with potential cost implications. Trial Registration: ClinicalTrials.gov NCT03387735; https://www.clinicaltrials.gov/ct2/show/NCT03387735. International Registered Report Identifier (IRRID): DERR1-10.2196/25175 %M 33605887 %R 10.2196/25175 %U http://www.researchprotocols.org/2021/2/e25175/ %U https://doi.org/10.2196/25175 %U http://www.ncbi.nlm.nih.gov/pubmed/33605887 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 2 %P e24893 %T Access to Technology and Preferences for an mHealth Intervention to Promote Medication Adherence in Pediatric Acute Lymphoblastic Leukemia: Approach Leveraging Behavior Change Techniques %A Heneghan,Mallorie B %A Hussain,Tasmeen %A Barrera,Leonardo %A Cai,Stephanie W %A Haugen,Maureen %A Morgan,Elaine %A Rossoff,Jenna %A Weinstein,Joanna %A Hijiya,Nobuko %A Cella,David %A Badawy,Sherif M %+ Division of Pediatric Hematology/Oncology, Department of Pediatrics, University of Utah, 100 N Mario Capecchi Drive, Salt Lake City, UT, 84113, United States, 1 801 662 4700, Mallorie.Heneghan@hsc.utah.edu %K acute lymphoblastic leukemia %K medication adherence %K behavior change technique %K oral chemotherapy %K mHealth %K patient-centered %D 2021 %7 18.2.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Suboptimal adherence to 6-mercaptopurine (6-MP) is prevalent in pediatric acute lymphoblastic leukemia (ALL) and associated with increased risk of relapse. Rapid uptake of personal technology makes mobile health (mHealth) an attractive platform to promote adherence. Objective: Study objectives were to examine access to mobile technology and preferences for an mHealth intervention to improve medication adherence in pediatric ALL. Methods: A cross-sectional survey was administered in oncology clinic to parents of children with ALL as well as adolescents and young adults (AYAs) with ALL receiving maintenance chemotherapy. Results: A total of 49 parents (median age [IQR] 39 [33-42] years; female 76% [37/49]) and 15 patients (median age [IQR] 17 [16-19]; male 80% [12/15]) participated. All parents and AYAs owned electronic tablets, smartphones, or both. Parents’ most endorsed mHealth app features included a list of medications (71%, 35/49), information about 6-MP (71%, 35/49), refill reminders (71%, 35/49), and reminders to take 6-MP (71%, 35/49). AYAs' most endorsed features included refill reminders (73%, 11/15), reminders to take 6-MP (73%, 11/15), and tracking 6-MP (73%, 11/15). Conclusions: Parents and AYAs reported ubiquitous access to mobile technology and strong interest in multiple adherence-specific mHealth app features. Parents and AYAs provided valuable insight into preferred features for a multifunctional behavioral intervention (mHealth app) to promote medication adherence in pediatric ALL. %M 33599621 %R 10.2196/24893 %U http://www.jmir.org/2021/2/e24893/ %U https://doi.org/10.2196/24893 %U http://www.ncbi.nlm.nih.gov/pubmed/33599621 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 2 %P e20329 %T Induction of Efficacy Expectancies in an Ambulatory Smartphone-Based Digital Placebo Mental Health Intervention: Randomized Controlled Trial %A Stalujanis,Esther %A Neufeld,Joel %A Glaus Stalder,Martina %A Belardi,Angelo %A Tegethoff,Marion %A Meinlschmidt,Gunther %+ Department of Clinical Psychology and Cognitive Behavioral Therapy, International Psychoanalytic University Berlin, Stromstraße 1, Berlin, 10555, Germany, 49 30 300117 710, gunther.meinlschmidt@ipu-berlin.de %K digital placebo effect %K efficacy expectancies %K ecological momentary assessment %K mHealth %K mobile phone %K placebo effect %K randomized controlled trial %K smartphone-based intervention %D 2021 %7 17.2.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: There is certain evidence on the efficacy of smartphone-based mental health interventions. However, the mechanisms of action remain unclear. Placebo effects contribute to the efficacy of face-to-face mental health interventions and may also be a potential mechanism of action in smartphone-based interventions. Objective: This study aimed to investigate whether different types of efficacy expectancies as potential factors underlying placebo effects could be successfully induced in a smartphone-based digital placebo mental health intervention, ostensibly targeting mood and stress. Methods: We conducted a randomized, controlled, single-blinded, superiority trial with a multi-arm parallel design. Participants underwent an Android smartphone-based digital placebo mental health intervention for 20 days. We induced prospective efficacy expectancies via initial instructions on the purpose of the intervention and retrospective efficacy expectancies via feedback on the success of the intervention at days 1, 4, 7, 10, and 13. A total of 132 healthy participants were randomized to a prospective expectancy–only condition (n=33), a retrospective expectancy–only condition (n=33), a combined expectancy condition (n=34), or a control condition (n=32). As the endpoint, we assessed changes in efficacy expectancies with the Credibility Expectancy Questionnaire, before the intervention and on days 1, 7, 14, and 20. For statistical analyses, we used a random effects model for the intention-to-treat sample, with intervention day as time variable and condition as two factors: prospective expectancy (yes vs no) and retrospective expectancy (yes vs no), allowed to vary over participant and intervention day. Results: Credibility (β=−1.63; 95% CI −2.37 to −0.89; P<.001) and expectancy (β=−0.77; 95% CI −1.49 to −0.05; P=.04) decreased across the intervention days. For credibility and expectancy, we found significant three-way interactions: intervention day×prospective expectancy×retrospective expectancy (credibility: β=2.05; 95% CI 0.60-3.50; P=.006; expectancy: β=1.55; 95% CI 0.14-2.95; P=.03), suggesting that efficacy expectancies decreased least in the combined expectancy condition and the control condition. Conclusions: To our knowledge, this is the first empirical study investigating whether efficacy expectancies can be successfully induced in a specifically designed placebo smartphone-based mental health intervention. Our findings may pave the way to diminish or exploit digital placebo effects and help to improve the efficacy of digital mental health interventions. Trial Registration: Clinicaltrials.gov NCT02365220; https://clinicaltrials.gov/ct2/show/NCT02365220. %M 33594991 %R 10.2196/20329 %U http://mhealth.jmir.org/2021/2/e20329/ %U https://doi.org/10.2196/20329 %U http://www.ncbi.nlm.nih.gov/pubmed/33594991 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 2 %P e18311 %T Effect of a Parent-Focused eHealth Intervention on Children’s Fruit, Vegetable, and Discretionary Food Intake (Food4toddlers): Randomized Controlled Trial %A Røed,Margrethe %A Medin,Anine C %A Vik,Frøydis N %A Hillesund,Elisabet R %A Van Lippevelde,Wendy %A Campbell,Karen %A Øverby,Nina C %+ Department of Nutrition and Public Health, University of Agder, Boks 422, Kristiansand, 4604, Norway, 47 91311933, margrethe.roed@uia.no %K toddler %K child %K eHealth %K intervention %K randomized controlled trial %K fruit %K vegetable %K discretionary food %D 2021 %7 16.2.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: In Western countries, children’s diets are often low in fruits and vegetables and high in discretionary foods. Diet in early life tends to track through childhood and youth and even into adulthood. Interventions should, therefore, be delivered in periods when habitual traits are established, as in toddlerhood when children adapt to their family’s diet. Objective: In this study, we assessed the effect of the Food4toddlers eHealth intervention, which aimed to enhance toddlers’ diets by shaping their food and eating environment. Methods: The Food4toddlers randomized controlled trial was conducted in Norway in 2017-2018. Parent-child dyads were recruited through social media. In total, 298 parents completed an online questionnaire at baseline (mean child age 10.9 months, SD 1.2). Postintervention questionnaires were completed immediately after the intervention (ie, follow-up 1; mean child age 17.8 months, SD 1.3) and 6 months after the intervention (ie, follow-up 2; mean child age 24.2 months, SD 1.9). The intervention was guided by social cognitive theory, which targets the linked relationship between the person, the behavior, and the environment. The intervention group (148/298, 49.7%) got access to the Food4toddlers website for 6 months from baseline. The website included information on diet and on how to create a healthy food and eating environment as well as activities, recipes, and collaboration opportunities. To assess intervention effects on child diet from baseline to follow-up 1 and from baseline to follow-up 2, we used generalized estimating equations and a time × group interaction term. Between-group differences in changes over time for frequency and variety of fruits and vegetables and frequency of discretionary foods were assessed. Results: At follow-up 1, a significant time × group interaction was observed for the frequency of vegetable intake (P=.02). The difference between groups in the change from baseline to follow-up 1 was 0.46 vegetable items per day (95% CI 0.06-0.86) in favor of the intervention group. No other significant between-group differences in dietary changes from baseline to follow-up 1 or follow-up 2 were observed. However, there is a clear time trend showing that the intake of discretionary foods increases by time from less than 1 item per week at baseline to more than 4 items per week at 2 years of age (P<.001), regardless of group. Conclusions: A positive intervention effect was observed for the frequency of vegetable intake at follow-up 1 but not at follow-up 2. No other between-group effects on diet were observed. eHealth interventions of longer duration, including reminders after the main content of the intervention has been delivered, may be needed to obtain long-terms effects, along with tailoring in a digital or a personal form. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 92980420; https://doi.org/10.1186/ISRCTN92980420 %M 33591279 %R 10.2196/18311 %U http://www.jmir.org/2021/2/e18311/ %U https://doi.org/10.2196/18311 %U http://www.ncbi.nlm.nih.gov/pubmed/33591279 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 2 %P e25578 %T Durability of Abstinence After Completing a Comprehensive Digital Smoking Cessation Program Incorporating a Mobile App, Breath Sensor, and Coaching: Cohort Study %A Marler,Jennifer D %A Fujii,Craig A %A Galanko,Joseph A %A Balbierz,Daniel J %A Utley,David S %+ Carrot Inc., 1400A Seaport Blvd, Suite 501, Redwood City, CA, 94063, United States, 1 415 757 7696, marler@carrot.co %K smoking cessation %K digital health %K smartphone %K digital sensor %K carbon monoxide %K breath sensor %K biofeedback %K mobile apps %K health promotion %K app %D 2021 %7 15.2.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite decreasing prevalence over the last several decades, cigarette smoking remains the leading cause of preventable death and disease, underscoring the need for innovative, effective solutions. Pivot is a novel, inclusive smoking cessation program designed for smokers along the entire spectrum of readiness to quit. Pivot leverages proven methods and technological advancements, including a personal portable breath carbon monoxide sensor, smartphone app, and in-app text-based coaching. We previously reported outcomes from the end of active Pivot program participation in 319 adult smokers. Herein, we report longer-term follow up in this cohort. Objective: The aim of this study was to assess and report participant outcomes 3 months after completion of Pivot, including smoking behavior, quit rates, continuous abstinence rates and durability, and predictors of abstinence. Methods: This prospective remote cohort study included US-based cigarette smokers aged 18 to 65 years who smoked ≥5 cigarettes per day (CPD). Three months after completion of active participation in Pivot, final follow-up data were collected via an online questionnaire. Outcomes included smoking behavior (CPD and quit attempts), self-reported quit rates (7- and 30-day point prevalence abstinence [PPA]), and continuous abstinence rates (proportion who achieved uninterrupted abstinence) and duration. Exploratory regression analyses were performed to identify baseline characteristics associated with achievement of 7-day PPA, 30-day PPA, and continuous abstinence. Results: A total of 319 participants completed onboarding (intention-to-treat [ITT]); 288/319 participants (90.3%) completed follow up (completers) at a mean of 7.2 (SD 1.2) months after onboarding. At final follow up, CPD were reduced by 52.6% (SE 2.1; P<.001) among all 319 participants, and most completers (152/288, 52.8%) reduced their CPD by at least 50%. Overall, most completers (232/288, 80.6%) made at least one quit attempt. Quit rates increased after the end of Pivot; using ITT analyses, 35.4% (113/319) achieved 7-day PPA and 31.3% (100/319) achieved 30-day PPA at final follow up compared with 32.0% (102/319) and 27.6% (88/319), respectively, at the end of the Pivot program. Continuous abstinence was achieved in about a quarter of those who onboarded (76/319, 23.8%) and in most who reported 30-day PPA at the end of Pivot (76/88, 86.4%), with a mean abstinence duration of 5.8 (SD 0.6) months. In exploratory regression analyses, lower baseline CPD, more positive baseline attitudes reflecting higher self-efficacy (higher confidence to quit and lower perceived difficulty of quitting), and higher education were associated with achieving abstinence. Conclusions: This study provides the first longer-term outcomes of the Pivot smoking cessation program. At final follow up, quit rates increased and continuous abstinence was favorable; the majority who achieved abstinence at the end of Pivot sustained abstinence throughout follow up. Decreases in CPD persisted and most participants made a quit attempt. Overall, final follow-up outcomes were stable or improved when compared to previous outcomes from the end of the program. These findings validate earlier results, and suggest that Pivot is an effective and durable solution for smoking cessation. Trial Registration: ClinicalTrials.gov NCT03295643; https://clinicaltrials.gov/ct2/show/NCT03295643 %M 33482628 %R 10.2196/25578 %U http://www.jmir.org/2021/2/e25578/ %U https://doi.org/10.2196/25578 %U http://www.ncbi.nlm.nih.gov/pubmed/33482628 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 2 %P e24703 %T Effectiveness of Smartphone-Based Cognitive Behavioral Therapy Among Patients With Major Depression: Systematic Review of Health Implications %A Hrynyschyn,Robert %A Dockweiler,Christoph %+ Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Health and Nursing Science, Campus Virchow Klinikum, Berlin, 13353, Germany, 49 30 450 529 124, robert.hrynyschyn@charite.de %K mobile health %K depression %K cognitive behavioral therapy %K systematic review %K mobile phone %D 2021 %7 10.2.2021 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Depression is often associated with rapid changes in mood and quality of life that persist for a period of 2 weeks. Despite medical innovations, there are problems in the provision of care. Long waiting times for treatment and high recurrence rates of depression cause enormous costs for health care systems. At the same time, comprehensive limitations in physical, psychological, and social dimensions are observed for patients with depression, which significantly reduce their quality of life. In addition to patient-specific limitations, undersupply and inappropriate health care have been determined. For this reason, new forms of care are discussed. Smartphone-based therapy is considered to have great potential due to its reach and easy accessibility. Low socioeconomic groups, which are always difficult to reach for public health interventions, can now be accessed due to the high dispersion of smartphones. There is still little information about the impact and mechanisms of smartphone-based therapy on depression. In a systematic literature review, the health implications of smartphone-based therapy were presented in comparison with standard care. Objective: The objective of this review was to identify and summarize the existing evidence regarding smartphone-based cognitive behavioral therapy for patients with depression and to present the health implications of smartphone-based cognitive behavioral therapy of considered endpoints. Methods: A systematic literature review was conducted to identify relevant studies by means of inclusion and exclusion criteria. For this purpose, the PubMed and Psyndex databases were systematically searched using a search syntax. The endpoints of depressive symptoms, depression-related anxiety, self-efficacy or self-esteem, and quality of life were analyzed. Identified studies were evaluated for study quality and risk of bias. After applying the inclusion and exclusion criteria, 8 studies were identified. Results: The studies examined in this review reported contradictory results regarding the investigated endpoints. In addition, due to clinical and methodological heterogeneity, it was difficult to derive evident results. All included studies reported effects on depressive symptoms. The other investigated endpoints were only reported by isolated studies. Only 50% (4/8) of the studies reported effects on depression-related anxiety, self-efficacy or self-esteem, and quality of life. Conclusions: No clear implications of smartphone-based cognitive behavioral therapy could be established. Evidence for the treatment of depression using smartphone-based cognitive behavioral therapy is limited. Additional research projects are needed to demonstrate the effects of smartphone-based cognitive behavioral therapy in the context of evidence-based medicine and to enable its translation into standard care. Participatory technology development might help to address current problems in mobile health intervention studies. %M 33565989 %R 10.2196/24703 %U http://mhealth.jmir.org/2021/2/e24703/ %U https://doi.org/10.2196/24703 %U http://www.ncbi.nlm.nih.gov/pubmed/33565989 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 2 %P e23502 %T Recommendations for Designing Health Information Technologies for Mental Health Drawn From Self-Determination Theory and Co-design With Culturally Diverse Populations: Template Analysis %A Cheng,Vanessa Wan Sze %A Piper,Sarah E %A Ottavio,Antonia %A Davenport,Tracey A %A Hickie,Ian B %+ Brain and Mind Centre, The University of Sydney, 94 Mallett Street, Camperdown, Sydney, 2050, Australia, 61 93510774, vanessa.cheng@sydney.edu.au %K mental health %K health information technologies %K self-determination theory %K eHealth %K internet %K digital health %K adolescent %K mental health services %K young adult %K LGBTQ persons %K mobile phone %K rural health %D 2021 %7 10.2.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Culturally diverse populations (including Aboriginal and Torres Strait Islander people, people of diverse genders and sexualities, and culturally and linguistically diverse people) in nonurban areas face compounded barriers to accessing mental health care. Health information technologies (HITs) show promising potential to overcome these barriers. Objective: This study aims to identify how best to improve a mental health and well-being HIT for culturally diverse Australians in nonurban areas. Methods: We conducted 10 co-design workshops (N=105 participants) in primary youth mental health services across predominantly nonurban areas of Australia and conducted template analysis on the workshop outputs. Owing to local (including service) demographics, the workshop participants naturalistically reflected culturally diverse groups. Results: We identified 4 main themes: control, usability, affirmation, and health service delivery factors. The first 3 themes overlap with the 3 basic needs postulated by self-determination theory (autonomy, competence, and relatedness) and describe participant recommendations on how to design an HIT. The final theme includes barriers to adopting HITs for mental health care and how HITs can be used to support care coordination and delivery. Hence, it describes participant recommendations on how to use an HIT. Conclusions: Although culturally diverse groups have specific concerns, their expressed needs fall broadly within the relatively universal design principles identified in this study. The findings of this study provide further support for applying self-determination theory to the design of HITs and reflect the tension in designing technologies for complex problems that overlap multiple medical, regulatory, and social domains, such as mental health care. Finally, we synthesize the identified themes into general recommendations for designing HITs for mental health and provide concrete examples of design features recommended by participants. %M 33565985 %R 10.2196/23502 %U https://www.jmir.org/2021/2/e23502 %U https://doi.org/10.2196/23502 %U http://www.ncbi.nlm.nih.gov/pubmed/33565985 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 2 %P e21700 %T Evidence on Technology-Based Psychological Interventions in Diagnosed Depression: Systematic Review %A Köhnen,Moritz %A Dreier,Mareike %A Seeralan,Tharanya %A Kriston,Levente %A Härter,Martin %A Baumeister,Harald %A Liebherz,Sarah %+ Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistr 52, Hamburg, 20246, Germany, 49 407410 ext 57705, m.koehnen@uke.de %K internet %K telephone %K psychotherapy %K depression %K depressive disorder %K systematic review %K mobile phone %D 2021 %7 10.2.2021 %9 Review %J JMIR Ment Health %G English %X Background: Evidence on technology-based psychological interventions (TBIs) for the treatment of depression is rapidly growing and covers a broad scope of research. Despite extensive research in this field, guideline recommendations are still limited to the general effectiveness of TBIs. Objective: This study aims to structure evidence on TBIs by considering different application areas (eg, TBIs for acute treatment and their implementation in health care, such as stand-alone interventions) and treatment characteristics (eg, therapeutic rationale of TBIs) to provide a comprehensive evidence base and to identify research gaps in TBIs for diagnosed depression. Moreover, the reporting of negative events in the included studies is investigated in this review to enable subsequent safety assessment of the TBIs. Methods: Randomized controlled trials on adults diagnosed with unipolar depression receiving any kind of psychotherapeutic treatment, which was at least partly delivered by a technical medium, were eligible for inclusion in our preregistered systematic review. We searched for trials in CENTRAL (Cochrane Central Register of Controlled Trials; until August 2020), MEDLINE, PsycINFO, PSYNDEX, CINAHL; until the end of January 2018), clinical trial registers, and sources of gray literature (until the end of January 2019). Study selection and data extraction were conducted by 2 review authors independently. Results: Database searches resulted in 15,546 records, of which 241 publications were included, representing 83 completed studies and 60 studies awaiting classification (ie, preregistered studies, study protocols). Almost all completed studies (78/83, 94%) addressed the acute treatment phase, being largely either implemented as stand-alone interventions (66/83, 80%) or blended treatment approaches (12/83, 14%). Studies on TBIs for aftercare (4/83, 5%) and for bridging waiting periods (1/83, 1%) were scarce. Most TBI study arms (n=107) were guided (59/107, 55.1%), delivered via the internet (80/107, 74.8%), and based on cognitive behavioral treatment approaches (88/107, 79.4%). Almost all studies (77/83, 93%) reported information on negative events, considering dropouts from treatment as a negative event. However, reports on negative events were heterogeneous and largely unsystematic. Conclusions: Research has given little attention to studies evaluating TBIs for aftercare and for bridging waiting periods in people with depression, even though TBIs are seen as highly promising in these application areas; thus, high quality studies are urgently needed. In addition, the variety of therapeutic rationales on TBIs has barely been represented by identified studies hindering the consideration of patient preferences when planning treatment. Finally, future studies should use specific guidelines to systematically assess and report negative events. Trial Registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42016050413; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42016050413. International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2018-028042 %M 33565981 %R 10.2196/21700 %U https://mental.jmir.org/2021/2/e21700 %U https://doi.org/10.2196/21700 %U http://www.ncbi.nlm.nih.gov/pubmed/33565981 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 2 %P e22694 %T Identification of Behavior Change Techniques From Successful Web-Based Interventions Targeting Alcohol Consumption, Binge Eating, and Gambling: Systematic Review %A Humphreys,Gabrielle %A Evans,Rebecca %A Makin,Harriet %A Cooke,Richard %A Jones,Andrew %+ School of Psychology, University of Liverpool, Eleanor Rathbone Building, L69 7ZT, Liverpool, United Kingdom, 44 07311550101, gabrielle.humphreys@liverpool.ac.uk %K systematic review %K web-based intervention %K behavior and behavior mechanism %K behavior change technique %K alcohol consumption %K binge eating %K gambling %D 2021 %7 9.2.2021 %9 Review %J J Med Internet Res %G English %X Background: Web-based interventions are thought to overcome barriers to treatment, such as accessibility and geographical location, which can undermine the effectiveness of traditional face-to-face interventions. Owing to these features, researchers are increasingly testing the efficacy of web-based interventions as ways to reduce alcohol misuse, binge eating, and gambling. However, many web-based interventions have poorly defined mechanisms of action; therefore, it is often uncertain how they propose to bring about behavior change. Objective: This systematic review aims to identify effective behavior change techniques (BCTs) present in web-based interventions aimed at reducing alcohol consumption, binge eating, or gambling. Methods: This systematic review covered research conducted in the last 20 years. Inclusion criteria for interventions were web-based administration; targeting alcohol use, binge eating, and/or gambling; and reporting on baseline and postintervention measures of behavior. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines were followed. We coded intervention effectiveness, study quality, and BCTs present in the interventions. Results: Following removal of 4152 ineligible articles, 45 were included in the review: 32 (71%) targeted alcohol misuse, 6 (13%) targeted binge eating, and 7 (16%) targeted gambling. In total, 5 frequency counts were performed to identify the most commonly used BCTs: all studies, effective interventions, high-quality studies at 2 thresholds, and both high quality and effective studies. The results obtained from this were integrated to identify 7 BCTs. These 7 BCTs were problem solving, feedback on behavior, self-monitoring of behavior, self-monitoring of outcomes, instruction on how to perform a behavior, information about social and health consequences, and social comparison. A total of 4 BCTs were found in all frequency counts: feedback on behavior, self-monitoring of behavior, instruction on how to perform a behavior, and social comparison. Self-monitoring of outcomes of behavior was found in 3 of the 5 frequency counts, problem solving was found in 2 frequency counts, and information about social and health consequences was found in 1 frequency count. Conclusions: This systematic review identified 7 of the most frequently used BCTs used in web-based interventions focused on alcohol misuse, binge eating, and gambling. These results can inform the development of evidence-based eHealth interventions that have the potential to lead to effective, positive behavior changes in all 3 areas. %M 33560243 %R 10.2196/22694 %U http://www.jmir.org/2021/2/e22694/ %U https://doi.org/10.2196/22694 %U http://www.ncbi.nlm.nih.gov/pubmed/33560243 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 1 %P e15410 %T Feasibility of the Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitor (IDEAL CGM) Training and Follow-Up Support Intervention: Randomized Controlled Pilot Study %A Smith,Madison B %A Albanese-O'Neill,Anastasia %A Yao,Yingwei %A Wilkie,Diana J %A Haller,Michael J %A Keenan,Gail M %+ College of Nursing, University of Florida, 1225 Center Drive, HPNP Room 3229, PO Box 100197, Gainesville, FL, United States, 1 4074432555, madisonbricksmith@gmail.com %K type 1 diabetes mellitus %K continuous glucose monitor %K web-based training %K diabetes education %K intervention %D 2021 %7 9.2.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Proper training and follow-up for patients new to continuous glucose monitor (CGM) use are required to maintain adherence and achieve diabetes-related outcomes. However, CGM training is hampered by the lack of evidence-based standards and poor reimbursement. We hypothesized that web-based CGM training and education would be effective and could be provided with minimal burden to the health care team. Objective: The aim of this study was to perform a pilot feasibility study testing a theory-driven, web-based intervention designed to provide extended training and follow-up support to adolescents and young adults newly implementing CGM and to describe CGM adherence, glycemic control, and CGM-specific psychosocial measures before and after the intervention. Methods: The “Intervention Designed to Educate and improve Adherence through Learning to use CGM (IDEAL CGM)” web-based training intervention was based on supporting literature and theoretical concepts adapted from the health belief model and social cognitive theory. Patients new to CGM, who were aged 15-24 years with type 1 diabetes for more than 6 months were recruited from within a public university’s endocrinology clinic. Participants were randomized to enhanced standard care or enhanced standard care plus the IDEAL CGM intervention using a 1:3 randomization scheme. Hemoglobin A1c levels and psychosocial measures were assessed at baseline and 3 months after start of the intervention. Results: Ten eligible subjects were approached for recruitment and 8 were randomized. Within the IDEAL CGM group, 4 of the 6 participants received exposure to the web-based training. Half of the participants completed at least 5 of the 7 modules; however, dosage of the intervention and level of engagement varied widely among the participants. This study provided proof of concept for use of a web-based intervention to deliver follow-up CGM training and support. However, revisions to the intervention are needed in order to improve engagement and determine feasibility. Conclusions: This pilot study underscores the importance of continued research efforts to optimize the use of web-based intervention tools for their potential to improve adherence and glycemic control and the psychosocial impact of the use of diabetes technologies without adding significant burden to the health care team. Enhancements should be made to the intervention to increase engagement, maximize responsiveness, and ensure attainment of the skills necessary to achieve consistent use and improvements in glycemic control prior to the design of a larger well-powered clinical trial to establish feasibility. Trial Registration: ClinicalTrials.gov NCT03367351, https://clinicaltrials.gov/ct2/show/NCT03367351. %M 33560234 %R 10.2196/15410 %U http://diabetes.jmir.org/2021/1/e15410/ %U https://doi.org/10.2196/15410 %U http://www.ncbi.nlm.nih.gov/pubmed/33560234 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 2 %P e22220 %T A Web-Based Self-Management Support Prototype for Adults With Chronic Kidney Disease (My Kidneys My Health): Co-Design and Usability Testing %A Donald,Maoliosa %A Beanlands,Heather %A Straus,Sharon E %A Smekal,Michelle %A Gil,Sarah %A Elliott,Meghan J %A Herrington,Gwen %A Harwood,Lori %A Waldvogel,Blair %A Delgado,Maria %A Sparkes,Dwight %A Tong,Allison %A Grill,Allan %A Novak,Marta %A James,Matthew Thomas %A Brimble,K Scott %A Samuel,Susan %A Tu,Karen %A Farragher,Janine %A Hemmelgarn,Brenda R %+ Faculty of Medicine and Dentistry, University of Alberta, 2J2.01 Walter C MacKenzie Health Sciences Centre, Edmonton, AB, T6G 2B7, Canada, 1 780 492 9728, Brenda.Hemmelgarn@albertahealthservices.ca %K chronic kidney disease %K knowledge-to-action framework %K integrated knowledge translation %K patient engagement %K patient-oriented research %K self-management %K web-based intervention %D 2021 %7 9.2.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Supporting patients to self-manage their chronic kidney disease (CKD) has been identified as a research priority by patients with CKD and those who care for them. Self-management has been shown to slow CKD progression and improve the quality of life of individuals living with the disease. Previous work has identified a need for a person-centered, theory-informed, web-based tool for CKD self-management that can be individualized to a patient’s unique situation, priorities, and preferences. We addressed this gap using an integrated knowledge translation method and patient engagement principles. Objective: The aim of this study is to conduct systematic co-design and usability testing of a web-based self-management prototype for adults with CKD (nondialysis and nontransplant) and their caregivers to enhance self-management support. Methods: A multistep, iterative system development cycle was used to co-design and test the My Kidneys My Health prototype. The 3-step process included creating website features and content using 2 sequential focus groups with patients with CKD and caregivers, heuristic testing using the 10 heuristic principles by Nielsen, and usability testing through in-person 60-minute interviews with patients with CKD and their caregivers. Patients with CKD, caregivers, clinicians, researchers, software developers, graphic designers, and policy makers were involved in all steps of this study. Results: In step 1, 18 participants (14 patients and 4 caregivers) attended one of the 2 sequential focus groups. The participants provided specific suggestions for simplifying navigation as well as suggestions to incorporate video, text, audio, interactive components, and visuals to convey information. A total of 5 reviewers completed the heuristic analysis (step 2), identifying items mainly related to navigation and functionality. Furthermore, 5 participants completed usability testing (step 3) and provided feedback on video production, navigation, features and functionality, and branding. Participants reported visiting the website repeatedly for the following features: personalized food tool, my health care provider question list, symptom guidance based on CKD severity, and medication advice. Usability was high, with a mean system usability score of 90 out of 100. Conclusions: The My Kidneys My Health prototype is a systematically developed, multifaceted, web-based CKD self-management support tool guided by the theory and preferences of patients with CKD and their caregivers. The website is user friendly and provides features that improve user experience by tailoring the content and resources to their needs. A feasibility study will provide insights into the acceptability of and engagement with the prototype and identify preliminary patient-reported outcomes (eg, self-efficacy) as well as potential factors related to implementation. This work is relevant given the shift to virtual care during the current pandemic times and provides patients with support when in-person care is restricted. %M 33560245 %R 10.2196/22220 %U https://formative.jmir.org/2021/2/e22220 %U https://doi.org/10.2196/22220 %U http://www.ncbi.nlm.nih.gov/pubmed/33560245 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 2 %P e18119 %T Adoption of Digital Health Technologies in the Practice of Behavioral Health: Qualitative Case Study of Glucose Monitoring Technology %A May,Suepattra G %A Huber,Caroline %A Roach,Meaghan %A Shafrin,Jason %A Aubry,Wade %A Lakdawalla,Darius %A Kane,John M %A Forma,Felicia %+ PRECISIONheor, 11100 Santa Monica Blvd, Suite 500, Los Angeles, CA, 90025, United States, 1 310 984 7739, suepattra.may-slater@precisionvh.com %K digital technology %K chronic disease %K blood glucose self-monitoring %K diabetes self-management %K real-time systems %K mental illness %K mobile phone %D 2021 %7 3.2.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Evaluation of patients with serious mental illness (SMI) relies largely on patient or caregiver self-reported symptoms. New digital technologies are being developed to better quantify the longitudinal symptomology of patients with SMI and facilitate disease management. However, as these new technologies become more widely available, psychiatrists may be uncertain about how to integrate them into daily practice. To better understand how digital tools might be integrated into the treatment of patients with SMI, this study examines a case study of a successful technology adoption by physicians: endocrinologists’ adoption of digital glucometers. Objective: This study aims to understand the key facilitators of and barriers to clinician and patient adoption of digital glucose monitoring technologies to identify lessons that may be applicable across other chronic diseases, including SMIs. Methods: We conducted focus groups with practicing endocrinologists from 2 large metropolitan areas using a semistructured discussion guide designed to elicit perspectives of and experiences with technology adoption. The thematic analysis identified barriers to and facilitators of integrating digital glucometers into clinical practice. Participants also provided recommendations for integrating digital health technologies into clinical practice more broadly. Results: A total of 10 endocrinologists were enrolled: 60% (6/10) male; a mean of 18.4 years in practice (SD 5.6); and 80% (8/10) working in a group practice setting. Participants stated that digital glucometers represented a significant change in the treatment paradigm for diabetes care and facilitated more effective care delivery and patient engagement. Barriers to the adoption of digital glucometers included lack of coverage, provider reimbursement, and data management support, as well as patient heterogeneity. Participant recommendations to increase the use of digital health technologies included expanding reimbursement for clinician time, streamlining data management processes, and customizing the technologies to patient needs. Conclusions: Digital glucose monitoring technologies have facilitated more effective, individualized care delivery and have improved patient engagement and health outcomes. However, key challenges faced by the endocrinologists included lack of reimbursement for clinician time and nonstandardized data management across devices. Key recommendations that may be relevant for other diseases include improved data analytics to quickly and accurately synthesize data for patient care management, streamlined software, and standardized metrics. %M 33533725 %R 10.2196/18119 %U https://www.jmir.org/2021/2/e18119 %U https://doi.org/10.2196/18119 %U http://www.ncbi.nlm.nih.gov/pubmed/33533725 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 2 %P e21465 %T Two Web-Based and Theory-Based Interventions With and Without Brief Motivational Interviewing in the Promotion of Human Papillomavirus Vaccination Among Chinese Men Who Have Sex With Men: Randomized Controlled Trial %A Wang,Zixin %A Lau,Joseph T F %A Ip,Tsun Kwan Mary %A Yu,Yebo %A Fong,Francois %A Fang,Yuan %A Mo,Phoenix K H %+ JC School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong, Room 508, School of Public Health,, Prince of Wales Hospital, Shatin, NT, Hong Kong, 666888, China, 86 22528740, wangzx@cuhk.edu.hk %K HPV vaccination %K web-based health promotion %K randomized controlled trial %K men who have sex with men %K China %K mobile phone %D 2021 %7 2.2.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Human papillomavirus (HPV) vaccination is effective in the prevention of vaccine-type genital warts and cancers among men who have sex with men (MSM). Objective: The primary objective of this randomized controlled trial (RCT) is to evaluate the efficacies of 2 web- and theory–based interventions with and without brief motivational interviewing (MI) over the phone to increase the completion of HPV vaccination among unvaccinated participants within a 24-month follow-up period compared with the control group. Methods: A 3-arm parallel-group RCT was conducted between July 2017 and December 2019. Five telephone surveys were conducted at baseline and at 3, 6, 9, and 24 months by blinded interviewers. Participants were Hong Kong Chinese–speaking MSM aged between 18 and 45 years with regular internet access who were recruited from outreaching at venues, web-based recruitment, and peer referral. Those who had ever received HPV vaccination were excluded. A total of 624 participants were randomized into either the online tutorial (OT) only group (n=208), the OT plus MI group (OT-MI; n=208), or the control group (n=208). In total, 459 (459/624, 73.6%) completed the follow-up evaluation at 24 months. Participants in the OT group received a fully automated OT developed based on the health belief model. On top of the same OT, the OT-MI group received brief MI over the phone. Reminders were sent to the participants of the OT and OT-MI groups after 1, 2, 4, 6, and 8 months. Participants in the control group received web-based health communication messages unrelated to HPV or HPV vaccination. The research team validated the self-reported HPV vaccination uptake. Intention-to-treat analysis was used for outcome analyses. Logistic regression models and multivariable linear regression models were used to test the between-group differences in primary and secondary outcomes. Baron and Kenny’s methods were used to test the mediation hypothesis. Results: The participants in the OT-MI group reported a significantly higher validated completion of HPV vaccination at 24 months than the control group (36/208, 17.3% vs 15/208, 7.2%; P=.006). However, the difference in HPV vaccination completion between the OT and the control groups (24/208, 11.5% vs 15/208, 7.2%; P=.17), or between OT-MI and OT groups (P=.13), was not statistically significant. The association between randomization status (OT-MI group vs control group) and HPV vaccination completion became statistically nonsignificant after controlling for changes in the perceived susceptibility to HPV (24 months vs baseline), whereas perceived susceptibility remained strongly associated with HPV vaccination uptake in the model (P<.001). Changes in perceived susceptibility fully mediated the intervention effect. Conclusions: Theory-based OT with brief MI over the phone was effective in increasing HPV vaccination completion among Chinese MSM. Perceived susceptibility is an active theoretical component that causes behavioral changes. Trial Registration: ClinicalTrials.gov NCT03286907; https://clinicaltrials.gov/ct2/show/NCT03286907 %M 33528372 %R 10.2196/21465 %U https://www.jmir.org/2021/2/e21465 %U https://doi.org/10.2196/21465 %U http://www.ncbi.nlm.nih.gov/pubmed/33528372 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 2 %P e26130 %T A Couples-Based Intervention (Ghya Bharari Ekatra) for the Primary Prevention of Intimate Partner Violence in India: Pilot Feasibility and Acceptability Study %A Kalokhe,Ameeta Shivdas %A Iyer,Sandhya %A Gadhe,Keshav %A Katendra,Tuman %A Kolhe,Ambika %A Rahane,Girish %A Stephenson,Rob %A Sahay,Seema %+ Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, 5003 CNR Building, 1518 Clifton Road, Atlanta, GA, 30322, United States, 1 404 712 1924, akalokh@emory.edu %K intimate partner violence %K prevention %K pilot study %K gender-based violence %K domestic violence %K violence %K India %K intervention %K prevalence %K mental health %K acceptance %K safety %K feasibility %K efficacy %D 2021 %7 1.2.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: The high global prevalence of intimate partner violence (IPV) and its association with poor physical and mental health underscore the need for effective primary prevention. We previously developed Ghya Bharari Ekatra (GBE), a couples-based primary prevention intervention for IPV among newly married couples residing in slum communities in Pune, India. Objective: Through this pilot study, we aimed to explore the acceptance, safety, feasibility, and preliminary efficacy of GBE. Methods: Between January and May 2018, we enrolled and assigned 20 couples to receive GBE plus information on IPV support services and 20 control couples to receive information on IPV support services alone. The GBE intervention was delivered over 6 weekly sessions to groups of 3 to 5 couples by lay peer educators in the communities in which the participants resided. Intervention components addressed relationship quality, resilience, communication and conflict negotiation, self-esteem, sexual communication and sexual health knowledge, and norms around IPV. Outcome evaluation included exit interviews with participants and peers to examine acceptance and feasibility challenges and baseline and 3-month follow-up interviews to examine change in IPV reporting and mental health (by women) and alcohol misuse (by men). The process evaluation examined dose delivered, dose received, fidelity, recruitment, participation rate, and context. Results: Half (40/83) of the eligible couples approached agreed to participate in the GBE intervention. Retention rates were high (17/20, 85% across all 6 sessions), feedback from exit interviews suggested the content and delivery methods were very well received, and the community was highly supportive of the intervention. The principal feasibility challenge involved recruiting men with the lowest income who were dependent on daily wages. No safety concerns were reported by female participants over the course of the intervention or at the 3-month follow-up. There were no reported physical or sexual IPV events in either group, but there were fewer incidents of psychological abuse in GBE participants (3/17, 18%) versus control participants (4/16, 25%) at 3-month follow-up. There was also significant improvement in the overall mental health of female intervention participants and declines in the control participants (change in mean General Health Questionnaire-12 score: –0.13 in intervention vs 0.13 in controls; P=.10). Conclusions: GBE has high acceptance, feasibility, and preliminary efficacy in preventing IPV and improving mental health among women. Next steps include refining the intervention content based on pilot findings and examining intervention efficacy through a large-scale randomized trial with longer follow-up. Trial Registration: ClinicalTrials.gov NCT03332134; https://clinicaltrials.gov/ct2/show/NCT03332134. Clinical Trials Registry of India CTRI/2018/01/011596; http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=21443 International Registered Report Identifier (IRRID): RR2-10.2196/11533 %M 33459278 %R 10.2196/26130 %U https://formative.jmir.org/2021/2/e26130 %U https://doi.org/10.2196/26130 %U http://www.ncbi.nlm.nih.gov/pubmed/33459278 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 2 %P e21335 %T Negative and Positive Affect Regulation in a Transdiagnostic Internet-Based Protocol for Emotional Disorders: Randomized Controlled Trial %A Díaz-García,Amanda %A González-Robles,Alberto %A García-Palacios,Azucena %A Fernández-Álvarez,Javier %A Castilla,Diana %A Bretón,Juana María %A Baños,Rosa María %A Quero,Soledad %A Botella,Cristina %+ Department of Psychology and Sociology, Universidad de Zaragoza, Calle Cdad. Escolar, S/N, 44003 Teruel, Teruel, 44003, Spain, 34 878618154, amandadiaz@unizar.es %K transdiagnostic %K positive affectivity %K negative affectivity %K emotion regulation %K emotional disorders %K internet %D 2021 %7 1.2.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Emotional disorders (EDs) are among the most prevalent mental disorders. Existing evidence-based psychological treatments are not sufficient to reduce the disease burden of mental disorders. It is therefore essential to implement innovative solutions to achieve a successful dissemination of psychological treatment protocols, and in this regard, the use of information and communication technologies such as the internet can be very useful. Furthermore, the literature suggests that not everyone with an ED receives the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which attempts to address the underlying processes common to EDs. Most of these transdiagnostic interventions focus primarily on downregulating negative affectivity (NA), and less attention has been paid to strengths and the upregulation of positive affectivity, despite its importance for well-being and mental health. Objective: This study aims to evaluate the efficacy of a transdiagnostic internet-based treatment for EDs in a community sample. Methods: A 3-armed randomized controlled trial was conducted. A total of 216 participants were randomly assigned to a transdiagnostic internet-based protocol (TIBP), a TIBP+ positive affect (PA) component, or a waiting list (WL) control group. The treatment protocol contained core components mainly addressed to downregulate NA (ie, present-focused emotional awareness and acceptance, cognitive flexibility, behavioral and emotional avoidance patterns, and interoceptive and situational exposure) as well as a PA regulation component to promote psychological strengths and enhance well-being. Data on depression, anxiety, quality of life, neuroticism and extraversion, and PA/NA before and after treatment were analyzed. Expectations and opinions of treatment were also analyzed. Results: Within-group comparisons indicated significant pre-post reductions in the two experimental conditions. In the TIBP+PA condition, the effect sizes were large for all primary outcomes (d=1.42, Beck Depression Inventory [BDI-II]; d=0.91, Beck Anxiety Inventory [BAI]; d=1.27, Positive and Negative Affect Schedule-Positive [PANAS-P]; d=1.26, Positive and Negative Affect Schedule-Negative [PANAS-N]), whereas the TIBP condition yielded large effect sizes for BDI-II (d=1.19) and PANAS-N (d=1.28) and medium effect sizes for BAI (d=0.63) and PANAS-P (d=0.69). Between-group comparisons revealed that participants who received one of the two active treatments scored better at posttreatment than WL participants. Although there were no statistically significant differences between the two intervention groups on the PA measure, effect sizes were consistently larger in the TIBP+PA condition than in the standard transdiagnostic protocol. Conclusions: Overall, the findings indicate that EDs can be effectively treated with a transdiagnostic intervention via the internet, as significant improvements in depression, anxiety, and quality of life measures were observed. Regarding PA measures, promising effects were found, but more research is needed to study the role of PA as a therapeutic component. Trial Registration: ClinicalTrials.gov NCT02578758; https://clinicaltrials.gov/ct2/show/NCT02578758 International Registered Report Identifier (IRRID): RR2-10.1186/s12888-017-1297-z %M 33522977 %R 10.2196/21335 %U https://www.jmir.org/2021/2/e21335 %U https://doi.org/10.2196/21335 %U http://www.ncbi.nlm.nih.gov/pubmed/33522977 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 2 %P e26155 %T Feasibility of a Web-Based Platform (Trial My App) to Efficiently Conduct Randomized Controlled Trials of mHealth Apps For Patients With Cardiovascular Risk Factors: Protocol For Evaluating an mHealth App for Hypertension %A Lokker,Cynthia %A Jezrawi,Rita %A Gabizon,Itzhak %A Varughese,Jobin %A Brown,Michael %A Trottier,Dan %A Alvarez,Elizabeth %A Schwalm,Jon-David %A McGillion,Michael %A Ma,Jinhui %A Bhagirath,Vinai %+ Health Information Research Unit, Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main St W, CRL 125, Hamilton, ON, L8S4L8, Canada, 1 905259140 ext 22208, LOKKERC@MCMASTER.CA %K mHealth %K mobile health %K hypertension %K app %K patient-oriented %K feasibility %K cardiovascular disease %K internet-administered %K randomized controlled trial %D 2021 %7 1.2.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Mobile health (mHealth) interventions can improve health by improving cardiovascular risk factors, but their adoption in care by physicians and patients is untapped. Few mHealth apps have been evaluated in clinical trials, and due to the fast pace of technological development, those previously evaluated are often outdated by the time trial results are available. Given the rapid pace of change in this field, it is not feasible to rigorously evaluate mHealth apps with current methodologies. Objective: The overall aim of this pilot study was to test the feasibility of using a web research platform called Trial My App to conduct efficient and rigorous web-based randomized controlled trials (RCTs) of mHealth apps relevant to patients with cardiovascular risk factors by evaluating an app that targets hypertension. Methods: For this study, 200 participants with suboptimally controlled hypertension will be recruited through advertisements in newsletters, media, and the internet, as well as through referrals from their health care providers. Screening, consent, randomization, and collection of patient-important health confidence and self-management ability outcomes will be conducted online through the Trial My App research platform. Participants will be randomized into 2 groups: 100 that will use an mHealth app for tracking hypertension and 100 that will be considered as an educational control. All participants will complete questionnaires at 0, 1, 3 and 6 months after enrolment. A substudy to validate the method of blood pressure readings and the consistency of data entered through Trial My App will be conducted with 40 participants. Results: The development of the Trial My App web platform has been completed. The creation of survey instruments has been completed in collaboration with our patient partners and advisory board. Recruitment is expected to begin in the first quarter of 2021; data collection and analysis are expected to be completed approximately 1 year after study commencement. Results will be disseminated through conferences and publications. The primary outcomes of this study include the feasibility of conducting an RCT using the Trial My App platform by reporting recruitment, retention, and completion statistics. We will validate app-entered data with a standard 7-day home blood pressure measurement method. Lastly, the pilot, nonblinded RCT will assess the effectiveness of the mHealth app in improving the control of hypertension compared with the control of hypertension in the educational control group. Conclusions: This study will determine if it is feasible to use the Trial My App web-based platform to evaluate the effectiveness of mHealth apps for patients with cardiovascular risk factors. As more mHealth apps are evaluated in RCTs, patients will be able to select apps that meet their needs and physicians will be able to make evidence-based recommendations to their patients for apps aimed at improving cardiovascular health. Trial Registration: ClinicalTrials.gov NCT04528654; https://clinicaltrials.gov/ct2/show/NCT04528654 International Registered Report Identifier (IRRID): PRR1-10.2196/26155 %M 33522978 %R 10.2196/26155 %U https://www.researchprotocols.org/2021/2/e26155 %U https://doi.org/10.2196/26155 %U http://www.ncbi.nlm.nih.gov/pubmed/33522978 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e23690 %T A Tailored Web- and Text-Based Intervention to Increase Physical Activity for Latino Men: Protocol for a Randomized Controlled Feasibility Trial %A Gans,Kim M %A Dulin,Akilah %A Palomo,Vanessa %A Benitez,Tanya %A Dunsiger,Shira %A Dionne,Laura %A Champion,Gregory %A Edgar,Rachelle %A Marcus,Bess %+ Department of Human Development and Family Sciences, University of Connecticut, 348 Mansfield Road, U-1058, Storrs, CT, 06269-1058, United States, 1 8604863865, kim.gans@uconn.edu %K physical activity %K Latino %K Hispanic %K men %K eHealth %K expert system %K internet %K text messaging %K mobile phone %K social media %D 2021 %7 29.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Latino men in the United States report low physical activity (PA) levels and related health conditions (eg, diabetes and obesity). Engaging in regular PA can reduce the risk of chronic diseases and yield many health benefits; however, there is a paucity of interventions developed exclusively for Latino men. Objective: To address the need for culturally relevant PA interventions, this study aims to develop and evaluate Hombres Saludables, a 6-month theory-based, tailored web- and text message-based PA intervention in Spanish for Latino men. This protocol paper describes the study design, intervention, and evaluation methods for Hombres Saludables. Methods: Latino men aged 18-65 years were randomized to either the individually tailored PA internet intervention arm or the nutrition and wellness internet control arm. The PA intervention included 2 check-in phone calls; automated SMS text messages; a pedometer; a 6-month gym membership; access to a private Facebook group; and an interactive website with PA tracking, goal setting, and individually tailored PA content. The primary outcomes were feasibility, acceptability, and efficacy (minutes per week of total moderate-to-vigorous PA assessed via the ActiGraph GT3X+ accelerometer worn at the waist and 7-day physical activity recall at baseline and 6 months). Secondary outcomes examined potential moderators (eg, demographics, acculturation, and environmental variables) and mediators (eg, self-efficacy and cognitive and behavioral processes of change) of treatment effects at 6 months post randomization. Results: This study was funded in September 2016. Initial institutional review board approval was received in February 2017, and focus groups and intervention development were conducted from April 2017 to January 2018. Recruitment for the clinical trial was carried out from February 2018 to July 2019. Baseline data collection was carried out from February 2018 to October 2019, with a total of 43 participants randomized. Follow-up data were collected through April 2020. Data cleaning and analysis are ongoing. Conclusions: We developed and tested protocols for a highly accessible, culturally and linguistically relevant, theory-driven PA intervention for Latino men. Hombres Saludables used an innovative, interactive, web- and text message–based intervention for improving PA among Latino men, an underserved population at risk of low PA and related chronic disease. If the intervention demonstrates feasibility, acceptability, and preliminary efficacy, we will refine and evaluate it in a larger randomized control trial. Trial Registration: Clinicaltrials.gov: NCT03196570; https://clinicaltrials.gov/ct2/show/NCT03196570 International Registered Report Identifier (IRRID): DERR1-10.2196/23690 %M 33512327 %R 10.2196/23690 %U http://www.researchprotocols.org/2021/1/e23690/ %U https://doi.org/10.2196/23690 %U http://www.ncbi.nlm.nih.gov/pubmed/33512327 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 1 %P e23410 %T Effectiveness of Smartphone-Based Mindfulness Training on Maternal Perinatal Depression: Randomized Controlled Trial %A Sun,Yaoyao %A Li,Yanyan %A Wang,Juan %A Chen,Qingyi %A Bazzano,Alessandra N %A Cao,Fenglin %+ School of Nursing and Rehabilitation, Shandong University, 44 Wenhua Xi Road, Jinan, 250012, China, 86 053188382291, caofenglin2008@126.com %K mindfulness %K pregnancy %K perinatal care %K depression %K mHealth %K mobile health %K psychosocial intervention %D 2021 %7 27.1.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite potential for benefit, mindfulness remains an emergent area in perinatal mental health care, and evidence of smartphone-based mindfulness training for perinatal depression is especially limited. Objective: The objective of this study was to evaluate the effectiveness of a smartphone-based mindfulness training intervention during pregnancy on perinatal depression and other mental health problems with a randomized controlled design. Methods: Pregnant adult women who were potentially at risk of perinatal depression were recruited from an obstetrics clinic and randomized to a self-guided 8-week smartphone-based mindfulness training during pregnancy group or attention control group. Mental health indicators were surveyed over five time points through the postpartum period by online self-assessment. The assessor who collected the follow-up data was blind to the assignment. The primary outcome was depression as measured by symptoms, and secondary outcomes were anxiety, stress, affect, sleep, fatigue, memory, and fear. Results: A total of 168 participants were randomly allocated to the mindfulness training (n=84) or attention control (n=84) group. The overall dropout rate was 34.5%, and 52.4% of the participants completed the intervention. Mindfulness training participants reported significant improvement of depression (group × time interaction χ24=16.2, P=.003) and secondary outcomes (χ24=13.1, P=.01 for anxiety; χ24=8.4, P=.04 for positive affect) compared to attention control group participants. Medium between-group effect sizes were found on depression and positive affect at postintervention, and on anxiety in late pregnancy (Cohen d=0.47, –0.49, and 0.46, respectively). Mindfulness training participants reported a decreased risk of positive depressive symptom (Edinburgh Postnatal Depression Scale [EPDS] score>9) compared to attention control participants postintervention (odds ratio [OR] 0.391, 95% CI 0.164-0.930) and significantly higher depression symptom remission with different EPDS reduction scores from preintervention to postintervention (OR 3.471-27.986). Parity did not show a significant moderating effect; however, for nulliparous women, mindfulness training participants had significantly improved depression symptoms compared to nulliparous attention control group participants (group × time interaction χ24=18.1, P=.001). Conclusions: Smartphone-based mindfulness training is an effective intervention in improving maternal perinatal depression for those who are potentially at risk of perinatal depression in early pregnancy. Nulliparous women are a promising subgroup who may benefit more from mindfulness training. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900028521; http://www.chictr.org.cn/showproj.aspx?proj=33474 %M 33502326 %R 10.2196/23410 %U http://www.jmir.org/2021/1/e23410/ %U https://doi.org/10.2196/23410 %U http://www.ncbi.nlm.nih.gov/pubmed/33502326 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 1 %P e22698 %T Efficacy of a Transdiagnostic Self-Help Internet Intervention for Reducing Depression, Anxiety, and Suicidal Ideation in Adults: Randomized Controlled Trial %A Batterham,Philip J %A Calear,Alison L %A Farrer,Louise %A Gulliver,Amelia %A Kurz,Ella %+ Centre for Mental Health Research, Research School of Population Health, Australian National University, 63 Eggleston Road, Canberra ACT, 2601, Australia, 61 261251031, philip.batterham@anu.edu.au %K depression %K anxiety %K randomized controlled trial %K internet %K implementation science %D 2021 %7 22.1.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Low-intensity self-guided mental health interventions that are delivered on the web may meet the needs and preferences of adults with mild to moderate symptoms. However, few clinical trials have examined the effectiveness of self-guided transdiagnostic interventions within a naturalistic setting. Objective: This randomized controlled trial (RCT) tests the effectiveness of the video-based transdiagnostic intervention FitMindKit in reducing depression symptoms (primary outcome), anxiety symptoms, disability, and suicidal ideation, relative to an attention-matched control condition called HealthWatch. Methods: The RCT was conducted with adults living in the Australian Capital Territory, Australia. Participants (n=1986) were recruited through the web using social media advertisements, screened for psychological distress, and then randomized to receive one of two 4-week programs: FitMindKit (12-module psychotherapy intervention) or HealthWatch (12-module program providing general health information). Participants were assessed at baseline and at 4 weeks postbaseline. To maintain the ecological validity of the trial, participants completed brief assessments and interventions without direct researcher contact or incentives. Results: Mixed model repeated-measures analyses of variance demonstrated that FitMindKit significantly improved depression symptoms (F1,701.7=3.97; P=.047), along with panic symptoms (F1,706.5=5.59; P=.02) and social anxiety symptoms (F1,680.0=12.37; P<.001), relative to the attention control condition. There were no significant effects on other outcomes. Conclusions: Self-guided transdiagnostic interventions can be beneficial when delivered directly to end users through the internet. Despite low adherence and small effect sizes, the availability of such interventions is likely to fill a critical gap in the accessibility of mental health services for the community. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618001688279; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376113. International Registered Report Identifier (IRRID): RR2-10.1016/j.conctc.2019.100341 %M 33480860 %R 10.2196/22698 %U https://www.jmir.org/2021/1/e22698 %U https://doi.org/10.2196/22698 %U http://www.ncbi.nlm.nih.gov/pubmed/33480860 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 7 %N 1 %P e18396 %T Cardiovascular Assessment Tool for Breast Cancer Survivors and Oncology Providers: Usability Study %A Weaver,Kathryn E %A Klepin,Heidi D %A Wells,Brian J %A Dressler,Emily V %A Winkfield,Karen M %A Lamar,Zanetta S %A Avery,Tiffany P %A Pajewski,Nicholas M %A Hundley,W Gregory %A Johnson,Aimee %A Davidson,Eleanor C %A Lopetegui,Marcelo %A Foraker,Randi E %+ Institute for Informatics, Washington University in St Louis School of Medicine, 600 S Taylor Avenue, Suite 102, Campus Box 8102, St Louis, MO, 63110, United States, 1 314 273 2211, randi.foraker@wustl.edu %K electronic health records %K clinical decision support %K usability testing %K cardiovascular diseases %K cancer survivors %K breast cancer %D 2021 %7 21.1.2021 %9 Original Paper %J JMIR Cancer %G English %X Background: Cardiovascular health is of increasing concern to breast cancer survivors and their health care providers, as many survivors are more likely to die from cardiovascular disease than cancer. Implementing clinical decision support tools to address cardiovascular risk factor awareness in the oncology setting may enhance survivors’ attainment or maintenance of cardiovascular health. Objective: We sought to evaluate survivors’ awareness of cardiovascular risk factors and examine the usability of a novel electronic health record enabled cardiovascular health tool from the perspective of both breast cancer survivors and oncology providers. Methods: Breast cancer survivors (n=49) recruited from a survivorship clinic interacted with the cardiovascular health tool and completed pre and posttool assessments about cardiovascular health knowledge and perceptions of the tool. Oncologists, physician assistants, and nurse practitioners (n=20) who provide care to survivors also viewed the cardiovascular health tool and completed assessments of perceived usability and acceptability. Results: Enrolled breast cancer survivors (84% White race, 4% Hispanic ethnicity) had been diagnosed 10.8 years ago (SD 6.0) with American Joint Committee on Cancer stage 0, I, or II (45/49, 92%). Prior to viewing the tool, 65% of survivors (32/49) reported not knowing their level for one or more cardiovascular health factors (range 0-4). On average, only 45% (range 0%-86%) of survivors’ known cardiovascular health factors were at an ideal level. More than 50% of survivors had ideal smoking status (45/48, 94%) or blood glucose level (29/45, 64%); meanwhile, less than 50% had ideal blood pressure (12/49, 24%), body mass index (12/49, 24%), cholesterol level (17/35, 49%), diet (7/49, 14%), and physical activity (10/49. 20%). More than 90% of survivors thought the tool was easy to understand (46/47, 98%), improved their understanding (43/47, 91%), and was helpful (45/47, 96%); overall, 94% (44/47 survivors) liked the tool. A majority of survivors (44/47, 94%) thought oncologists should discuss cardiovascular health during survivorship care. Most (12/20, 60%) oncology providers (female: 12/20, 60%; physicians: 14/20, 70%) had been practicing for more than 5 years. Most providers agreed the tool provided useful information (18/20, 90%), would help their effectiveness (18/20, 90%), was easy to use (20/20, 100%), and presented information in a useful format (19/20, 95%); and 85% of providers (17/20) reported they would use the tool most or all of the time when providing survivorship care. Conclusions: These usability data demonstrate acceptability of a cardiovascular health clinical decision support tool in oncology practices. Oncology providers and breast cancer survivors would likely value the integration of such apps in survivorship care. By increasing awareness and communication regarding cardiovascular health, electronic health record–enabled tools may improve survivorship care delivery for breast cancer and ultimately patient outcomes. %M 33475511 %R 10.2196/18396 %U http://cancer.jmir.org/2021/1/e18396/ %U https://doi.org/10.2196/18396 %U http://www.ncbi.nlm.nih.gov/pubmed/33475511 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e19506 %T Optimizing an Obesity Treatment Using the Multiphase Optimization Strategy Framework: Protocol for a Randomized Factorial Trial %A Bennett,Gary G %A Steinberg,Dori %A Bolton,Jamiyla %A Gallis,John A %A Treadway,Cayla %A Askew,Sandy %A Kay,Melissa C %A Pollak,Kathryn I %A Turner,Elizabeth L %+ Duke Global Health Institute, Duke University, 310 Trent Drive, Room 236, Durham, NC, 27708, United States, 1 9193954119, jamiyla.bolton@duke.edu %K text message %K digital health %K weight loss %K personalized %D 2021 %7 18.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Effective weight loss interventions exist, yet few can be scaled up for wide dissemination. Further, none has been fully delivered via text message. We used the multiphase optimization strategy (MOST) to develop multicomponent interventions that consist only of active components, those that have been experimentally determined to impact the chosen outcome. Objective: The goal of this study is to optimize a standalone text messaging obesity intervention, Charge, using the MOST framework to experimentally determine which text messaging components produce a meaningful contribution to weight change at 6 months. Methods: We designed a 6-month, weight loss texting intervention based on our interactive obesity treatment approach (iOTA). Participants are randomized to one of 32 experimental conditions to test which standalone text messaging intervention components produce a meaningful contribution to weight change at 6 months. Results: The project was funded in February 2017; enrollment began in January 2018 and data collection was completed in June 2019. Data analysis is in progress and first results are expected to be submitted for publication in 2021. Conclusions: Full factorial trials are particularly efficient in terms of cost and logistics when leveraged for standalone digital treatments. Accordingly, MOST has the potential to promote the rapid advancement of digital health treatments. Subject to positive findings, the intervention will be low cost, immediately scalable, and ready for dissemination. This will be of great potential use to the millions of Americans with obesity and the providers who treat them. Trial Registration: ClinicalTrials.gov NCT03254940; https://clinicaltrials.gov/ct2/show/NCT03254940 International Registered Report Identifier (IRRID): RR1-10.2196/19506 %M 33459600 %R 10.2196/19506 %U http://www.researchprotocols.org/2021/1/e19506/ %U https://doi.org/10.2196/19506 %U http://www.ncbi.nlm.nih.gov/pubmed/33459600 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 1 %P e20491 %T Digital Intervention With Lifestyle Coach Support to Target Dietary and Physical Activity Behaviors of Adults With Nonalcoholic Fatty Liver Disease: Systematic Development Process of VITALISE Using Intervention Mapping %A Hallsworth,Kate %A McPherson,Stuart %A Anstee,Quentin M %A Flynn,Darren %A Haigh,Laura %A Avery,Leah %+ Centre for Rehabilitation, School of Health & Life Sciences, Teesside University, Centuria Building, Middlesbrough, United Kingdom, 44 1642384130 ext 4130, leah.avery@tees.ac.uk %K nonalcoholic fatty liver disease %K internet-based intervention %K lifestyle %K diet %K physical activity %K weight loss %D 2021 %7 15.1.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Nonalcoholic fatty liver disease (NAFLD) is linked to excessive calorie consumption, physical inactivity, and being overweight. Patients with NAFLD can halt or decelerate progression and potentially reverse their condition by changing their lifestyle behavior. International guidelines recommend the use of lifestyle interventions; however, there remains a discordance between published guidelines and clinical practice. This is primarily due to a lack of NAFLD-specific interventions to support weight loss and improve liver function. Objective: This study aims to use intervention mapping to systematically develop a digital intervention to support patients with NAFLD to initiate and maintain changes in their dietary and physical activity behavior to promote weight loss. Methods: Intervention mapping consisted of 6 steps: step 1 involved a needs assessment with primary and secondary health care professionals (HCPs) and patients with NAFLD; step 2 involved identification of the social cognitive determinants of change and behavioral outcomes of the intervention; step 3 involved linking social cognitive determinants of behavioral outcomes with behavior change techniques to effectively target dietary and physical activity behavior; step 4 involved the development of a prototype digital intervention that integrated the strategies from step 3, and the information content was identified as important for improving knowledge and skills from steps 1 and 2; step 5 involved the development of an implementation plan with a digital provider of lifestyle behavior change programs to patients with NAFLD using their delivery platform and lifestyle coaches; and step 6 involved piloting the digital intervention with patients to obtain data on access, usability, and content. Results: A digital intervention was developed, consisting of 8 modules; self-regulatory tools; and provision of telephone support by trained lifestyle coaches to help facilitate behavioral intention, enactment, and maintenance. A commercial provider of digital lifestyle behavior change programs enrolled 16 patients with NAFLD to the prototype intervention for 12 consecutive weeks. A total of 11 of the 16 participants successfully accessed the intervention and continued to engage with the content following initial log-in (on average 4 times over the piloting period). The most frequently accessed modules were welcome to the program, understanding NAFLD, and food and NAFLD. Goal setting and self-monitoring tools were accessed on 22 occasions (4 times per tool on average). A total of 3 out of 11 participants requested access to a lifestyle coach. Conclusions: Intervention mapping provided a systematic methodological framework to guide a theory- and evidence-informed co-design intervention development process for patients and HCPs. The digital intervention with remote support by a lifestyle coach was acceptable to patients with NAFLD and feasible to deliver. Issues with initial access, optimization of information content, and promoting the value of remote lifestyle coach support require further development ahead of future research to establish intervention effectiveness. %M 33448929 %R 10.2196/20491 %U http://www.jmir.org/2021/1/e20491/ %U https://doi.org/10.2196/20491 %U http://www.ncbi.nlm.nih.gov/pubmed/33448929 %0 Journal Article %@ 2561-9128 %I JMIR Publications %V 4 %N 1 %P e23090 %T Swedish Web Version of the Quality of Recovery Scale Adapted for Patients Undergoing Local Anesthesia and Peripheral Nerve Blockade (SwQoR-LA): Prospective Psychometric Evaluation Study %A Nilsson,Ulrica %A Dahlberg,Karuna %A Jaensson,Maria %+ Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Alfred Nobels Allé 23, Huddinge, 14183, Sweden, 46 70 420 34 95, ulrica.nilsson@ki.se %K day surgery %K local anesthesia %K peripheral nerve blockade %K postoperative recovery %K psychometric evaluation %D 2021 %7 15.1.2021 %9 Original Paper %J JMIR Perioper Med %G English %X Background: The frequency and timing of assessing patient symptoms and discomfort during postoperative recovery are goals. Therefore, real-time recovery evaluation has been suggested to identify specific deficits in patient recovery. Objective: This study aimed to psychometrically evaluate the Swedish Web Version of the Quality of Recovery (SwQoR) Scale adapted for patients undergoing local and peripheral nerve block (SwQoR-LA). Methods: This was a secondary analysis of a psychometric evaluation of 107 patients aged ≥18 years undergoing day surgery under local or peripheral nerve block anesthesia at 4 different day surgery departments in Sweden. The SwQoR-LA, available through a mobile app called Recovery Assessment by Phone Points (RAPP), was completed daily on postoperative days 1-7. Results: Some evidence of construct validity was supported, and discriminant validity was found in 7 of 8 items related to general anesthesia. The internal consistency was acceptable (.87-.89), and the split-half reliability was 0.80-0.86. Cohen d effect size was 0.98, and the percentage of change from baseline was 43.4%. No floor nor ceiling effects were found. Conclusions: The SwQoR-LA is valid, reliable, responsive, and clinically feasible for digital real-time recovery assessment of patient recovery to identify specific deficits in patient recovery and detect those patients who might benefit from a timely intervention. Trial Registration: ClinicalTrials.gov NCT02492191; https://clinicaltrials.gov/ct2/show/NCT02492191 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2015-009901 %M 33448932 %R 10.2196/23090 %U http://periop.jmir.org/2021/1/e23090/ %U https://doi.org/10.2196/23090 %U http://www.ncbi.nlm.nih.gov/pubmed/33448932 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e25746 %T A Live Video Mind-Body Treatment to Prevent Persistent Symptoms Following Mild Traumatic Brain Injury: Protocol for a Mixed Methods Study %A Greenberg,Jonathan %A Singh,Tanya %A Iverson,Grant L %A Silverberg,Noah D %A Macklin,Eric A %A Parker,Robert A %A Giacino,Joseph T %A Yeh,Gloria Y %A Vranceanu,Ana-Maria %+ Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, 1 Bowdoin Square Suite #100, Boston, MA, 02114, United States, 1 6176439402, jgreenberg5@mgh.harvard.edu %K mild traumatic brain injury %K anxiety %K mixed methods %K intervention development %D 2021 %7 14.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Every year, approximately 42 million people sustain a mild traumatic brain injury (mTBI, also known as concussion), with particularly high rates among college-aged individuals. A substantial proportion of these people (44%-64%) develop persistent symptoms that are challenging to treat, costly, and associated with significant disability. Anxiety has emerged as a risk factor for progression from acute to persistent mTBI symptoms. Objective: This study aims to develop, adapt, and establish the feasibility of the Toolkit for Optimal Recovery after Concussions (TOR-C), an innovative mind-body program aimed at preventing persistent symptoms among young adults with mTBI and comorbid anxiety. Here, we describe the proposed study design, methodology, measurement, and treatment manuals. Methods: In phase 1, we will conduct individual, live video qualitative interviews (up to n=20) with college-aged individuals with mTBI and comorbid anxiety to inform adaptation of the intervention and study procedures. In phase 2, an open pilot of the live video TOR-C (n=5) with exit interviews will be conducted to explore the initial feasibility, acceptability, and credibility of the program and to refine the study procedures. Phase 3 will involve conducting a feasibility randomized controlled trial (N=50) of the TOR-C versus a health education control (Health Enhancement for Concussions; HE-C), both delivered via live video, to establish feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection; feasibility, credibility, and acceptability of the live video TOR-C and HE-C (adherence, retention, fidelity, and satisfaction) following prespecified benchmarks; and a signal of improvement in outcomes. Results: Phase 1 of the study has been approved by the Massachusetts General Hospital Institutional Review Board. Study completion is anticipated by early 2025. Conclusions: We will develop and test the first mind-body intervention focused on prevention of persistent symptoms following mTBI in young adults with comorbid anxiety problems. This will allow us to establish feasibility markers in postconcussive symptoms, anxiety, disability, and fear avoidance to inform a future efficacy trial of the TOR-C versus HE-C. International Registered Report Identifier (IRRID): PRR1-10.2196/25746 %M 33443484 %R 10.2196/25746 %U https://www.researchprotocols.org/2021/1/e25746 %U https://doi.org/10.2196/25746 %U http://www.ncbi.nlm.nih.gov/pubmed/33443484 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 1 %P e21275 %T Effects of Web-Based Social Connectedness on Older Adults’ Depressive Symptoms: A Two-Wave Cross-Lagged Panel Study %A Hwang,Juwon %A Toma,Catalina L %A Chen,Junhan %A Shah,Dhavan V %A Gustafson,David %A Mares,Marie-Louise %+ School of Journalism and Mass Communication, University of Wisconsin, 5007 Vilas Hall, 821 University Ave., Madison, WI, 53706, United States, 1 6083324571, jhwang79@wisc.edu %K depressive symptoms %K older adults %K web-based intervention %K online social support %K patient health questionnaire %K longitudinal survey %K mobile phone %D 2021 %7 13.1.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Depressive symptoms are the most prevalent mental health concern among older adults (possibly heightened during the COVID-19 pandemic), which raises questions about how such symptoms can be lowered in this population. Existing research shows that offline social connectedness is a protective factor against depression in older adults; however, it is unknown whether web-based social connectedness can have similar effects. Objective: This study investigates whether social connectedness on a support website protects older adults against depressive symptoms over the course of a year, above and beyond the protective effect of offline social connectedness. The secondary aim is to determine whether older adults with increased depressive symptoms are more likely to engage in social connectedness on this website. Thus, we examine depressive symptoms as both an outcome and predictor of web-based social connectedness to fully understand the chain of causality among these variables. Finally, we compare web-based social connectedness with offline social connectedness in their ability to lower depressive symptoms among older adults. Methods: A total of 197 adults aged 65 years or older were given access to a social support website, where they were able to communicate with each other via a discussion forum for a year. Participants’ social connectedness on the web-based platform, conceptualized as message production and consumption, was measured using behavioral log data as the number of messages participants wrote and read, respectively, during the first 6 months (t1) and the following 6 months (t2) of the study. Participants self-reported their offline social connectedness as the number of people in their support networks, and they reported their depressive symptoms using the Patient Health Questionnaire-8 both at baseline (t1) and at 12-month follow-up (t2). To ascertain the flow of causality between these variables, we employed a cross-lagged panel design, in which all variables were measured at t1 and t2. Results: After controlling for the effect of offline support networks at t1, web-based message consumption at t1 decreased older adults’ depressive symptoms at t2 (β=−.11; P=.02), but web-based message production at t1 did not impact t2 depressive symptoms (β=.12; P=.34). Web-based message consumption had a larger effect (β=−.11; P=.02) than offline support networks (β=−.08; P=.03) in reducing older adults’ depressive symptoms over time. Higher baseline depressive symptoms did not predict increased web-based message consumption (β=.12; P=.36) or production (β=.02; P=.43) over time. Conclusions: The more messages older adults read on the web-based forum for the first 6 months of the study, the less depressed they felt at the 1-year follow-up, above and beyond the availability of offline support networks at baseline. This pinpoints the substantial potential of web-based communication to combat depressive symptoms in this vulnerable population. International Registered Report Identifier (IRRID): RR2-10.1186/s13063-015-0713-2 %M 33439143 %R 10.2196/21275 %U http://www.jmir.org/2021/1/e21275/ %U https://doi.org/10.2196/21275 %U http://www.ncbi.nlm.nih.gov/pubmed/33439143 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 1 %P e18299 %T Effects of Website Interactivity on Skin Cancer–Related Intentions and User Experience: Factorial Randomized Experiment %A Niu,Zhaomeng %A Willoughby,Jessica Fitts %A Coups,Elliot J %A Stapleton,Jerod L %+ Section of Behavioral Sciences, Division of Medical Oncology, Rutgers Institute of New Jersey, 195 Little Albany Street, Room 5549-20, New Brunswick, NJ, 08903, United States, 1 5093393076, niuzm321@gmail.com %K behavioral intention %K computer-mediated communication %K skin cancer %K interactivity %K user experience %D 2021 %7 13.1.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital media technologies provide users with the ability to interact with content and to receive information based on their preferences and engagement. Objective: We used skin cancer and sun protection as a health topic to explore how modality interactivity, interface tools that afford users greater activity, resulting in greater depth and breadth of mentally representing and experiencing mediated content, and message interactivity, the extent to which the system allows users to exchange messages back and forth on health websites, influenced users’ attitudes, knowledge, behavioral intentions, and experience. Methods: We employed a 2×2 (modality interactivity: high vs low; message interactivity: high vs low) between-subject online experiment for which 4 websites were created. Participants (n=293) were recruited using Amazon Mechanical Turk and randomly assigned into to 1 of 4 conditions. After browsing the website, participants completed an online survey regarding their experience and cognitive perceptions. General linear models and path analysis were used to analyze the data. Results: Both modality interactivity (P=.001) and message interactivity (P<.001) had an impact on intention to use sun protection. Attitudes toward health websites and perceived knowledge mediated the effects of modality interactivity and message interactivity on sun protection use intention, individually. Participants in the high modality interactivity and high message interactivity condition felt more satisfied (P=.02). Participants in the low message interactivity condition had more interest in the experience with health websites than participants in the high message interactivity condition (P=.044). Conclusions: Findings suggested that modality interactivity influenced intention to use sun protection directly as well as via attitudes toward the websites. Message interactivity impacted intention to use sunscreen directly and also through perceived knowledge. Implications for designing health websites and health intervention content are discussed. %M 33439131 %R 10.2196/18299 %U http://www.jmir.org/2021/1/e18299/ %U https://doi.org/10.2196/18299 %U http://www.ncbi.nlm.nih.gov/pubmed/33439131 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 1 %P e21445 %T Resource-Based Internet Intervention (Med-Stress) to Improve Well-Being Among Medical Professionals: Randomized Controlled Trial %A Smoktunowicz,Ewelina %A Lesnierowska,Magdalena %A Carlbring,Per %A Andersson,Gerhard %A Cieslak,Roman %+ Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland, 48 506354565, esmoktunowicz@swps.edu.pl %K well-being %K job stress %K internet intervention %K self-efficacy %K perceived social support %K medical professionals %D 2021 %7 11.1.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Medical professionals are exposed to multiple and often excessive demands in their work environment. Low-intensity internet interventions allow them to benefit from psychological support even when institutional help is not available. Focusing on enhancing psychological resources—self-efficacy and perceived social support—makes an intervention relevant for various occupations within the medical profession. Previously, these resources were found to operate both individually or sequentially with self-efficacy either preceding social support (cultivation process) or following it (enabling process). Objective: The objective of this randomized controlled trial is to compare the efficacy of 4 variants of Med-Stress, a self-guided internet intervention that aims to improve the multifaceted well-being of medical professionals. Methods: This study was conducted before the COVID-19 pandemic. Participants (N=1240) were recruited mainly via media campaigns and social media targeted ads. They were assigned to 1 of the following 4 groups: experimental condition reflecting the cultivation process, experimental condition reflecting the enabling process, active comparator enhancing only self-efficacy, and active comparator enhancing only perceived social support. Outcomes included 5 facets of well-being: job stress, job burnout, work engagement, depression, and job-related traumatic stress. Measurements were taken on the web at baseline (time 1), immediately after intervention (time 2), and at a 6-month follow-up (time 3). To analyze the data, linear mixed effects models were used on the intention-to-treat sample. The trial was partially blinded as the information about the duration of the trial, which was different for experimental and control conditions, was public. Results: At time 2, job stress was lower in the condition reflecting the cultivation process than in the one enhancing social support only (d=−0.21), and at time 3, participants in that experimental condition reported the lowest job stress when compared with all 3 remaining study groups (ds between −0.24 and −0.41). For job-related traumatic stress, we found a significant difference between study groups only at time 3: stress was lower in the experimental condition in which self-efficacy was enhanced first than in the active comparator enhancing solely social support (d=−0.24). The same result was found for work engagement (d=−0.20), which means that it was lower in exactly the same condition that was found beneficial for stress relief. There were no differences between study conditions for burnout and depression neither at time 2 nor at time 3. There was a high dropout in the study (1023/1240, 82.50% at posttest), reflecting the pragmatic nature of this trial. Conclusions: The Med-Stress internet intervention improves some components of well-being—most notably job stress—when activities are completed in a specific sequence. The decrease in work engagement could support the notion of dark side of this phenomenon, but further research is needed. Trial Registration: ClinicalTrials.gov NCT03475290; https://clinicaltrials.gov/ct2/show/NCT03475290 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-019-3401-9 %M 33427674 %R 10.2196/21445 %U https://www.jmir.org/2021/1/e21445 %U https://doi.org/10.2196/21445 %U http://www.ncbi.nlm.nih.gov/pubmed/33427674 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 1 %P e19737 %T Uptake of Proactively Offered Online and Telephone Support Services Targeting Multiple Health Risk Behaviors Among Vocational Education Students: Process Evaluation of a Cluster Randomized Controlled Trial %A Atorkey,Prince %A Paul,Christine %A Bonevski,Billie %A Wiggers,John %A Mitchell,Aimee %A Byrnes,Emma %A Lecathelinais,Christophe %A Tzelepis,Flora %+ School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, University Drive, Callaghan, Newcastle, 2308, Australia, 61 0249246565, prince.atorkey@uon.edu.au %K uptake %K proactive offer %K online support services %K telephone support services %K multiple health risk behaviors %K vocational education students %D 2021 %7 6.1.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: A high proportion of vocational education students smoke tobacco, have inadequate nutrition (ie, low fruit and vegetable intake), drink alcohol at risky levels, or are physically inactive. The extent to which vocational education students will sign up for proactively offered online and telephone support services for multiple health risk behaviors is unknown. Objective: The aim of this study is to examine the uptake of proactively offered online and telephone support services for smoking, nutrition, alcohol consumption, and physical activity risk behaviors, individually and in combination, among vocational education students in the Technical and Further Education (TAFE) setting. The characteristics associated with the uptake of online or telephone services for smoking, nutrition, alcohol consumption, and physical activity risk behaviors were also examined. Methods: Vocational education students enrolled in a TAFE class in New South Wales, Australia, which ran for 6 months or more, were recruited to participate in a cluster randomized controlled trial from May 2018 to May 2019. In the intervention arm, participants who did not meet the Australian health guidelines for each of the smoking, nutrition, alcohol consumption, and physical activity risk behaviors were provided electronic feedback and proactively offered online and telephone support services. Uptake of support was measured by whether participants signed up for the online and telephone services they were offered. Results: Vocational education students (N=551; mean age 25.7 years, SD 11.1; 310/551, 56.3% male) were recruited into the intervention arm. Uptake of the proactive offer of either online or telephone services was 14.5% (59/406) for fruit and vegetables, 12.7% (29/228) for physical activity, 6.8% (13/191) for smoking, and 5.5% (18/327) for alcohol use. Uptake of any online or telephone service for at least two health behaviors was 5.8% (22/377). Participants who were employed (odds ratio [OR] 0.10, 95% CI 0.01-0.72) and reported not being anxious (OR 0.11, 95% CI 0.02-0.71) had smaller odds of signing up for online or telephone services for smoking, whereas participants who reported not being depressed had greater odds (OR 10.25, 95% CI 1.30-80.67). Participants who intended to change their physical activity in the next 30 days had greater odds (OR 4.01, 95% CI 1.33-12.07) of signing up for online or telephone services for physical activity. Employed participants had smaller odds (OR 0.18, 95% CI 0.06-0.56) of signing up for support services for at least two behaviors. Conclusions: Although the uptake of proactively offered online and telephone support services is low, these rates appear to be higher than the self-initiated use of some of these services in the general population. Scaling up the proactive offer of online and telephone services may produce beneficial health outcomes. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12618000723280; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375001. %M 33404504 %R 10.2196/19737 %U https://www.jmir.org/2021/1/e19737 %U https://doi.org/10.2196/19737 %U http://www.ncbi.nlm.nih.gov/pubmed/33404504 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 1 %P e18934 %T Digital Health Needs of Women With Postpartum Depression: Focus Group Study %A Lackie,Madison E %A Parrilla,Julia S %A Lavery,Brynn M %A Kennedy,Andrea L %A Ryan,Deirdre %A Shulman,Barbara %A Brotto,Lori A %+ Women's Health Research Institute, BC Women's Hospital + Health Centre, Box 42B, H214 - 4500 Oak St., Vancouver, BC, V6H 3N1, Canada, 1 604 875 3459, lori.brotto@vch.ca %K postpartum depression %K perinatal mental health %K eHealth %K women’s health %K reproductive health %K maternal health %K qualitative research %K focus groups %K user-centered design %K knowledge translation %K self-management %D 2021 %7 6.1.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Although approximately 10% of new mothers in Canada develop postpartum depression (PPD), they face many barriers when accessing care. eHealth offers a unique opportunity to provide psychosocial skills and support to new mothers; however, patient populations are not consistently engaged in eHealth development processes. Thus, the diversity of women’s backgrounds and needs are often not reflected in existing tools. Objective: This study aims to engage women from a variety of backgrounds and locations around British Columbia (BC) who have previously experienced PPD to determine the unmet psychoeducational needs of women with PPD and how a web-enabled platform used to deliver psychosocial skills and education to assist in the management of PPD could fulfill those needs. Methods: Focus groups were conducted in 7 cities across BC with a total of 31 women (mean age 34.5 years, SD 4.9), with each group ranging from 2-7 participants. Focus groups were cofacilitated by the study coordinator and a local service provider in each community using a semistructured guide to discuss participants’ needs, ideas, and opinions as they relate to the use of technology in PPD management. Transcripts were approached inductively using thematic analysis to identify themes and qualitative description to frame what was observed in the data. Results: A total of 5 themes were identified: bridging gaps to meet needs; providing validation to combat stigma; nurturing capacity to cope, manage, and/or reach wellness; empowering people to take ownership over their mental health; and offering customization to ensure relevance. Each theme identified a need (eg, combatting stigma) and a way to address that need using a web-enabled intervention (eg, providing validation). At the intersection of these themes was the overarching value of promoting agency for women experiencing PPD. Conclusions: Ultimately, new mothers require accessible mental health care that promotes their agency in mental health care decision making. Our participants believed that a web-enabled intervention could help meet this need. These data will be used to guide the design of such an intervention, with the eventual implementation of this resource as a first-line management option for PPD. %M 33404506 %R 10.2196/18934 %U https://www.jmir.org/2021/1/e18934 %U https://doi.org/10.2196/18934 %U http://www.ncbi.nlm.nih.gov/pubmed/33404506 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 1 %P e21542 %T Effect of Internet-Based Rehabilitation Programs on Improvement of Pain and Physical Function in Patients with Knee Osteoarthritis: Systematic Review and Meta-analysis of Randomized Controlled Trials %A Xie,Su-Hang %A Wang,Qian %A Wang,Li-Qiong %A Wang,Lin %A Song,Kang-Ping %A He,Cheng-Qi %+ Rehabilitation Medicine Center, West China Hospital, Sichuan University, No 37 Guoxue Street, Wuhou District, Chengdu, Sichuan, 610041, China, 86 28 8542 2847, hxkfhcq2015@126.com %K internet-based rehabilitation %K knee %K osteoarthritis %K pain %K physical function %K meta-analysis %K review %K telerehabilitation %K eHealth %K telemedicine %D 2021 %7 5.1.2021 %9 Review %J J Med Internet Res %G English %X Background: Osteoarthritis (OA) is a chronic, debilitating, and degenerative joint disease. However, it is difficult for patients with knee OA to access conventional rehabilitation when discharging from the hospital. Internet-based rehabilitation is one of the promising telemedicine strategies to provide a means combining monitoring, guidance, and treatment for patients with knee OA. Objective: The aim of this study was to conduct a systematic review and meta-analysis for assessing the effect of internet-based rehabilitation programs on pain and physical function in patients with knee OA. Methods: Keywords related to knee OA and internet-based rehabilitation were systematically searched in the Web of Science, MEDLINE, EMBASE, CENTRAL, Scopus, PEDro (Physiotherapy Evidence Database), CNKI, SinoMed, and WANFANG databases from January 2000 to April 2020. Only randomized controlled trials were included. The authors independently screened the literature. The main outcome measures were focused on pain and physical function. A meta-analysis was performed on the collected data. Review Manager (RevMan, version 5.3) was used for all analyses. Results: The systematic review identified 6 randomized controlled trials, 4 of which were included in the meta-analysis, comprising a total of 791 patients with knee OA. The meta-analysis with the fixed-effects model showed that the internet-based rehabilitation programs could significantly alleviate the osteoarthritic pain for patients compared with conventional rehabilitation (standardized mean difference [SMD] –0.21, 95% CI  −0.4 to –0.01, P=.04). No significant difference was found in the improvement of physical function in patients with knee OA compared with conventional rehabilitation within 2 to 12 months (SMD –0.08, 95% CI −0.27 to 0.12, P=.43). Conclusions: This systematic review shows that internet-based rehabilitation programs could improve the pain but not physical function for patients with knee OA. However, there was a very small number of studies that could be included in the review and meta-analysis. Thus, further studies with large sample sizes are warranted to promote the effectiveness of internet-based rehabilitation and to develop its personalized design. %M 33399542 %R 10.2196/21542 %U https://www.jmir.org/2021/1/e21542 %U https://doi.org/10.2196/21542 %U http://www.ncbi.nlm.nih.gov/pubmed/33399542 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 12 %P e19658 %T Internet-Based Support and Coaching With Complementary Clinic Visits for Young People With Attention-Deficit/Hyperactivity Disorder and Autism: Controlled Feasibility Study %A Sehlin,Helena %A Hedman Ahlström,Britt %A Bertilsson,Ingrid %A Andersson,Gerhard %A Wentz,Elisabet %+ Gillberg Neuropsychiatry Centre, Institute of Neuroscience and Physiology, University of Gothenburg, Kungsgatan 12, Gothenburg, SE 411 19, Sweden, 46 736838212, helena.sehlin@vgregion.se %K attention-deficit/hyperactivity disorder %K autism %K coaching %K internet-based intervention %K social support %D 2020 %7 31.12.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Individuals with attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) can experience obstacles in traditional health care situations due to difficulties associated with their impairment. Objective: This controlled study aims to investigate the feasibility of an internet-based support and coaching intervention (IBSC), including 2 weekly chat sessions and 2 complementary clinic visits with coaches over the course of 8 weeks, for adolescents and young adults with ADHD and/or ASD in 2 naturalistic routine care settings. Methods: Individuals with ADHD and/or ASD aged 15-32 years were recruited in 2 clinical settings, where they received either IBSC (n=24) or treatment as usual (TAU; n=20). Outcome measures included self-report questionnaires assessing quality of life (Manchester Short Assessment for Quality of Life), sense of coherence (Sense Of Coherence 29), self-esteem (Rosenberg Self-Esteem Scale), and anxiety and depressive symptoms (Hospital Anxiety and Depression Scale [HADS] and Montgomery-Åsberg Depression Rating Scale-Self-reported, respectively). Results: Significant between-group effects were observed in measures of anxiety (HADS) at postintervention (P=.02) as well as at the 6-month follow-up (P=.004). Significant between-group effects were also noted for depressive symptoms (HADS) postintervention (P=.04). The between-group effects were partially explained by a deterioration in the TAU group. A significant increase in self-esteem (P=.04) as well as a decrease in anxiety (P=.003) at the 6-month follow-up was observed in the intervention group following IBSC. Findings from a qualitative study of the intervention are consistent with the results. Conclusions: The findings from this study suggest that IBSC holds promise as a feasible complement or alternative to traditional face-to-face health care meetings. %M 33382381 %R 10.2196/19658 %U http://www.jmir.org/2020/12/e19658/ %U https://doi.org/10.2196/19658 %U http://www.ncbi.nlm.nih.gov/pubmed/33382381 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 12 %P e19238 %T Feasibility and Acceptability of a Remotely Delivered, Web-Based Behavioral Intervention for Men With Prostate Cancer: Four-Arm Randomized Controlled Pilot Trial %A Chan,June M %A Van Blarigan,Erin L %A Langlais,Crystal S %A Zhao,Shoujun %A Ramsdill,Justin W %A Daniel,Kimi %A Macaire,Greta %A Wang,Elizabeth %A Paich,Kellie %A Kessler,Elizabeth R %A Beer,Tomasz M %A Lyons,Karen S %A Broering,Jeanette M %A Carroll,Peter R %A Kenfield,Stacey A %A Winters-Stone,Kerri M %+ University of California, San Francisco, UCSF Box 0560, 550 16th St. 2nd Floor, San Francisco, CA, 94158, United States, 1 415 476 1111 ext 13608, erin.vanblarigan@ucsf.edu %K diet %K physical activity %K exercise %K lifestyle %K cancer %K survivorship %K text messages %K internet %D 2020 %7 31.12.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Diet and exercise may be associated with quality of life and survival in men with prostate cancer. Objective: This study aimed to determine the feasibility and acceptability of a remotely delivered web-based behavioral intervention among men with prostate cancer. Methods: We conducted a multi-site 4-arm pilot randomized controlled trial of a 3-month intervention (TrueNTH Community of Wellness). Eligibility included self-reported prostate cancer diagnosis, having a personal device that connected to the internet, age ≥18 years, and ability to read English and receive text messages and emails. Men receiving chemotherapy or radiation, or those who reported contraindications to exercise, could participate with physician clearance. Participants were randomized (1:1:1:1) to additive intervention levels: website; website and personalized diet and exercise prescription; website, personalized prescription, Fitbit, and text messages; and website, personalized prescription, Fitbit, text messages, and 2 30-minute phone calls—one with an exercise trainer and one with a registered dietician. Primary outcomes were feasibility (accrual and attrition) and acceptability (survey data and website use). We described self-reported diet and exercise behavior at the time of enrollment, 3 months, and 6 months as secondary outcomes. Results: In total, 202 men consented and were randomized between August 2017 and September 2018 (level 1: 49, level 2: 51, level 3: 50, level 4: 52). A total of 160 men completed the onboarding process and were exposed to their randomly assigned intervention (38, 38, 42, and 42 in levels 1, 2, 3, and 4, respectively). The follow-up rate was 82.7% (167/202) at 3 months and 77.2% (156/202) at 6 months. Participants had a median age of 70 years and were primarily White and college educated. Website visit frequency over the 3-month intervention period increased across levels (median: 2, 9, 11, and 16 visits for levels 1, 2, 3, and 4, respectively). Most were satisfied or very satisfied with the intervention (20/39, 51%; 27/42, 64%; 23/44, 52%; and 27/42, 64% for levels 1, 2, 3, and 4, respectively). The percentage of men who reported being very satisfied was highest among level 4 participants (10/42, 24% vs 4/39, 10%; 5/42, 12%; and 5/44, 11% for levels 1, 2, and 3, respectively). Dissatisfaction was highest in level 1 (5/39, 13% vs 1/42, 2%; 3/44, 7%; and 2/42, 5% for levels 2, 3, and 4, respectively). We observed small improvements in diet and physical activity at 3 months among men in level 4 versus those in level 1. Conclusions: A web-based, remotely delivered, tailored behavioral intervention for men with prostate cancer is feasible. Future studies are warranted to increase the effect of the intervention on patient behavior while maintaining sustainability and scalability as well as to design and implement interventions for more diverse populations. Trial Registration: ClinicalTrials.gov NCT03406013; http://clinicaltrials.gov/ct2/show/NCT03406013 %M 33382378 %R 10.2196/19238 %U http://www.jmir.org/2020/12/e19238/ %U https://doi.org/10.2196/19238 %U http://www.ncbi.nlm.nih.gov/pubmed/33382378 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 12 %P e21328 %T Digital Health Interventions for People With Type 2 Diabetes to Develop Self-Care Expertise, Adapt to Identity Changes, and Influence Other’s Perception: Qualitative Study %A Turnbull,Sophie %A Lucas,Patricia J %A Hay,Alastair D %A Cabral,Christie %+ Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, United Kingdom, 44 7855 115, sophie.turnbull@bristol.ac.uk %K social identity %K diabetes mellitus %K internet-based intervention %K health care disparities %K socioeconomic factors %K self care %D 2020 %7 21.12.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: A diagnosis of type 2 diabetes (T2D) results in widespread changes to a person’s life and can be experienced as an assault on their sense of self. The resources available to an individual influence how the individual adapts to their diabetic identity and subsequently engages in self-care. Digital interventions can be viewed as a resource that people can draw on to adapt to the diagnosis. However, there is an indication that people from disadvantaged groups find digital health technologies more challenging to access and use, which may increase health inequalities. Objective: This study aims to gain insights into how and why people with T2D use digital self-care technology and how experiences vary between individuals and social groups. Methods: A purposive sample of people who had used a digital intervention to help them self-care for their T2D were recruited for the study. Semistructured interviews were conducted, and data were analyzed thematically. Results: A diverse sample of 21 participants were interviewed. Participants used digital interventions to help them to understand and feel more in control of their bodies. Digital interventions were used by participants to project their chosen identity to others. Participants selected technology that allowed them to confirm and enact their preferred positive identities, both by avoiding stigma and by becoming experts in their disease or treatment. Participants preferred using digital interventions that helped them conceal their diabetes, including by buying discrete blood glucose monitors. Some participants used technology to increase their sense of power in their interaction with clinicians, whereas others used technology to demonstrate their goodness. Conclusions: The technology that people with T2D have access to shapes the way they are able to understand and control their bodies and support preferred social identities. %M 33346733 %R 10.2196/21328 %U http://www.jmir.org/2020/12/e21328/ %U https://doi.org/10.2196/21328 %U http://www.ncbi.nlm.nih.gov/pubmed/33346733 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 3 %N 2 %P e19749 %T Qualitative Evaluation of Web-Based Digital Intervention to Prevent and Reduce Excessive Alcohol Use and Harm Among Young People Aged 14-15 Years: A “Think-Aloud” Study %A Tinner,Laura Elizabeth %A Kaner,Eileen %A Garnett,Claire %A Mitchell,Siobhan %A Hickman,Matthew %A Campbell,Rona %A MacArthur,Georgina %+ Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, United Kingdom, 44 117 33 13401, laura.tinner@bristol.ac.uk %K public health %K adolescent %K mobile phone %K alcoholic intoxication %K internet %D 2020 %7 15.12.2020 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: In the United Kingdom, despite some downward trends in alcohol use among young people, over one-fifth of young people reported excessive alcohol use in the past month, which is associated with short- and long-term harm to health. Digital interventions to reduce alcohol use, such as websites, among young people present an appealing and cost-effective mode of intervention that can be integrated into the education system. However, relatively few school-based digital alcohol-focused interventions have been developed and evaluated for young people in the United Kingdom. Objective: This study aims to develop a novel web-based intervention, Rethink Alcohol, to prevent and reduce excessive alcohol use and related harm among young people aged between 14 and 15 years, and explore the views of young people, teachers, and youth workers in relation to the content, design, and usability of the intervention. Methods: Intervention development followed the person-based approach, using theories of social norms and social influence. Qualitative “Think-Aloud” interviews, either one-to-one or paired, were conducted while participants perused and worked through the web-based intervention, talking aloud. Participants included 20 young people (12 female, 8 male), 5 youth workers (4 female, 1 male), 3 teachers (2 male, 1 female), and 1 (male) clinical professional, recruited via youth groups and professional networks. Interviews were audio recorded, transcribed verbatim, and analyzed thematically. Results: The prototype web-based intervention included normative feedback, information, a quiz, interactive activities, and scenarios. On a rating scale of impressions from poor (1) to excellent (5), participants gave an average score of 3.6/5. A total of 5 themes were identified: content, credibility of the website, making the website easy to understand, design and navigation, and suitability for the audience. These themes reflected views that the content was interesting, credible, informative, and embodied a neutral and nonjudgmental tone, but stronger messaging was needed regarding social pressures and short-term risks regarding safety and risk behavior alongside clarity around pathways of risk; credibility and trustworthiness of information were critical features, determined in part, by the professionalism of design and referencing of sources of information provided; and messages should be succinct and come to life through design and interactive features. Conclusions: Together, the data illustrated the importance and challenge of communicating nuanced alcohol-focused public health messages to young people in concise, clear, nonjudgmental, and appealing ways. Young people report interest in clear, credible, neutral, and interactive messages regarding social pressures and short-term risks of alcohol use via a web-based intervention. There is scope for optimization and feasibility testing of the Rethink Alcohol intervention. %M 33320100 %R 10.2196/19749 %U http://pediatrics.jmir.org/2020/2/e19749/ %U https://doi.org/10.2196/19749 %U http://www.ncbi.nlm.nih.gov/pubmed/33320100 %0 Journal Article %@ 2369-3762 %I JMIR Publications %V 6 %N 2 %P e19871 %T Evaluation of a Web-Based ADHD Awareness Training in Primary Care: Pilot Randomized Controlled Trial With Nested Interviews %A French,Blandine %A Hall,Charlotte %A Perez Vallejos,Elvira %A Sayal,Kapil %A Daley,David %+ Division of Psychiatry & Applied Psychology School of Medicine, University of Nottingham, Triumph Road, Jubilee Campus, Nottingham, , United Kingdom, 44 01158230261, david.daley@nottingham.ac.uk %K ADHD %K primary care %K general practice %K randomized controlled trial %K online intervention %K interviews %D 2020 %7 11.12.2020 %9 Original Paper %J JMIR Med Educ %G English %X Background: Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder affecting up to 5% of children and adults. Undiagnosed and untreated ADHD can result in adverse long-term health, educational, and social impacts for affected individuals. Therefore, it is important to identify this disorder as early as possible. General practitioners (GPs) frequently play a gatekeeper role in access to specialist services in charge of diagnosis and treatment. Studies have shown that their lack of knowledge and understanding about ADHD can create barriers to care. Objective: This pilot randomized controlled trial assesses the efficacy of a web-based psychoeducation program on ADHD tailored for GPs. Methods: A total of 221 participants were randomized to either a sham intervention control or an awareness training intervention and they completed questionnaires on ADHD knowledge, confidence, and attitude at 3 time points (preintervention, postintervention, and 2-week follow-up). Participants in the intervention arm were invited to participate in a survey and follow-up interview between 3 and 6 months after the intervention. Results: The responses of 109 GPs were included in the analysis. The knowledge (P<.001) and confidence (P<.001) of the GPs increased after the intervention, whereas misconceptions decreased (P=.04); this was maintained at the 2-week follow-up (knowledge, P<.001; confidence, P<.001; misconceptions, P=.03). Interviews and surveys also confirmed a change in practice over time. Conclusions: These findings demonstrate that a short web-based intervention can increase GPs’ understanding, attitude, and practice toward ADHD, potentially improving patients’ access to care. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN45400501; http://www.isrctn.com/ISRCTN45400501. %M 33306027 %R 10.2196/19871 %U http://mededu.jmir.org/2020/2/e19871/ %U https://doi.org/10.2196/19871 %U http://www.ncbi.nlm.nih.gov/pubmed/33306027 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 12 %P e21436 %T A Remote Nutritional Intervention to Change the Dietary Habits of Patients Undergoing Ablation of Atrial Fibrillation: Randomized Controlled Trial %A Goni,Leticia %A de la O,Víctor %A Barrio-López,M Teresa %A Ramos,Pablo %A Tercedor,Luis %A Ibañez-Criado,Jose Luis %A Castellanos,Eduardo %A Ibañez Criado,Alicia %A Macias Ruiz,Rosa %A García-Bolao,Ignacio %A Almendral,Jesus %A Martínez-González,Miguel Ángel %A Ruiz-Canela,Miguel %+ Department of Preventive Medicine and Public Health, University of Navarra, C/ Irunlarrea, 1, Pamplona, Spain, 34 948425600 ext 806395, mcanela@unav.es %K atrial fibrillation %K secondary prevention %K remote intervention %K Mediterranean diet %K olive oil %D 2020 %7 7.12.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: The Prevention With Mediterranean Diet (PREDIMED) trial supported the effectiveness of a nutritional intervention conducted by a dietitian to prevent cardiovascular disease. However, the effect of a remote intervention to follow the Mediterranean diet has been less explored. Objective: This study aims to assess the effectiveness of a remotely provided Mediterranean diet–based nutritional intervention in obtaining favorable dietary changes in the context of a secondary prevention trial of atrial fibrillation (AF). Methods: The PREvention of recurrent arrhythmias with Mediterranean diet (PREDIMAR) study is a 2-year multicenter, randomized, controlled, single-blinded trial to assess the effect of the Mediterranean diet enriched with extra virgin olive oil (EVOO) on the prevention of atrial tachyarrhythmia recurrence after catheter ablation. Participants in sinus rhythm after ablation were randomly assigned to an intervention group (Mediterranean diet enriched with EVOO) or a control group (usual clinical care). The remote nutritional intervention included phone contacts (1 per 3 months) and web-based interventions with provision of dietary recommendations, and participants had access to a web page, a mobile app, and printed resources. The information is divided into 6 areas: Recommended foods, Menus, News and Online resources, Practical tips, Mediterranean diet classroom, and Your personal experience. At baseline and at 1-year and 2-year follow-up, the 14-item Mediterranean Diet Adherence Screener (MEDAS) questionnaire and a semiquantitative food frequency questionnaire were collected by a dietitian by phone. Results: A total of 720 subjects were randomized (365 to the intervention group, 355 to the control group). Up to September 2020, 560 subjects completed the first year (560/574, retention rate 95.6%) and 304 completed the second year (304/322, retention rate 94.4%) of the intervention. After 24 months of follow-up, increased adherence to the Mediterranean diet was observed in both groups, but the improvement was significantly higher in the intervention group than in the control group (net between-group difference: 1.8 points in the MEDAS questionnaire (95% CI 1.4-2.2; P<.001). Compared with the control group, the Mediterranean diet intervention group showed a significant increase in the consumption of fruits (P<.001), olive oil (P<.001), whole grain cereals (P=.002), pulses (P<.001), nuts (P<.001), white fish (P<.001), fatty fish (P<.001), and white meat (P=.007), and a significant reduction in refined cereals (P<.001), red and processed meat (P<.001), and sweets (P<.001) at 2 years of intervention. In terms of nutrients, the intervention group significantly increased their intake of omega-3 (P<.001) and fiber (P<.001), and they decreased their intake of carbohydrates (P=.02) and saturated fatty acids (P<.001) compared with the control group. Conclusions: The remote nutritional intervention using a website and phone calls seems to be effective in increasing adherence to the Mediterranean diet pattern among AF patients treated with catheter ablation. Trial Registration: ClinicalTrials.gov NCT03053843; https://www.clinicaltrials.gov/ct2/show/NCT03053843 %M 33284131 %R 10.2196/21436 %U http://www.jmir.org/2020/12/e21436/ %U https://doi.org/10.2196/21436 %U http://www.ncbi.nlm.nih.gov/pubmed/33284131 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 12 %P e23273 %T Effectiveness of WeChat for Improving Exclusive Breastfeeding in Huzhu County China: Randomized Controlled Trial %A Wu,Qiong %A Huang,Yiwen %A Liao,Zijun %A van Velthoven,Michelle Helena %A Wang,Wei %A Zhang,Yanfeng %+ Capital Institute of Pediatrics, No. 2 Yabao Road, Chaoyang District, Beijing, 100020, China, 86 10 85695554, summyzh@126.com %K breastfeeding %K exclusive breastfeeding %K WeChat %K mHealth %K randomized controlled trial %D 2020 %7 3.12.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: The benefits of breastfeeding for both infants and mothers have been well recognized. However, the exclusive breastfeeding rate in China is low and decreasing. Mobile technologies have rapidly developed; communication apps such as WeChat (one of the largest social networking platforms in China) are widely used and have the potential to conveniently improve health behaviors. Objective: This study aimed to assess the effectiveness of using WeChat to improve breastfeeding practices. Methods: This 2-arm randomized controlled trial was conducted among pregnant women from May 2019 to April 2020 in Huzhu County, Qinghai Province, China. Pregnant women were eligible to participate if they were aged 18 years or older, were 11 to 37 weeks pregnant with a singleton fetus, had no known illness that could limit breastfeeding after childbirth, used WeChat through their smartphone, and had access to the internet. A total of 344 pregnant women were recruited at baseline, with 170 in the intervention group and 174 in the control group. Women in the intervention group received breastfeeding knowledge and promotion information weekly through a WeChat official account from their third month of pregnancy to 6 months postpartum. The primary outcome of exclusive and predominant breastfeeding rate was measured 0-1 month, 2-3 months, and 4-5 months postpartum. Results: At 0-1 month postpartum, the exclusive breastfeeding rate was significantly higher in the intervention group than that in the control group (81.1% vs 63.3%; odds ratio [OR] 2.75, 95% CI 1.58-4.78; P<.001). Similarly, mothers in the intervention group were more likely to provide predominantly breast milk (OR 2.77, 95% CI 1.55-4.96; P<.001) and less likely to give dairy products to their children (OR 0.40, 95% CI 0.21-0.75; P=.005). There was no statistically significant difference for exclusive breastfeeding rate 2-3 months (P=.09) and 4-5 months postpartum (P=.27), though more children in the intervention group were exclusively breastfed than those in the control group 2-3 months postpartum (intervention: 111/152, 73.0%; control: 96/152, 63.2%) and 4-5 months postpartum(intervention: 50/108, 46.3%; control: 46/109, 42.2%). Conclusions: This study is the first effort to promote exclusive breastfeeding through WeChat in China, which proved to be an effective method of promoting exclusive breastfeeding in early life. WeChat health education can be used in addition to local breastfeeding promotion programs. Trial Registration: Chinese Clinical Trial Registry ChiCTR1800017364; http://www.chictr.org.cn/showproj.aspx?proj=29325 International Registered Report Identifier (IRRID): RR2-10.1186/s12889-019-7676-2 %M 33270026 %R 10.2196/23273 %U https://www.jmir.org/2020/12/e23273 %U https://doi.org/10.2196/23273 %U http://www.ncbi.nlm.nih.gov/pubmed/33270026 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 12 %P e19150 %T A Mobile- and Web-Based Health Intervention Program for Diabetes and Prediabetes Self-Management (BetaMe/Melon): Process Evaluation Following a Randomized Controlled Trial %A Signal,Virginia %A McLeod,Melissa %A Stanley,James %A Stairmand,Jeannine %A Sukumaran,Nitin %A Thompson,Donna-Marie %A Henderson,Kelly %A Davies,Cheryl %A Krebs,Jeremy %A Dowell,Anthony %A Grainger,Rebecca %A Sarfati,Diana %+ Department of Public Health, University of Otago Wellington, 23a Mein Street, Newtown, Wellington, , New Zealand, 64 212631385, virginia.signal@otago.ac.nz %K diabetes mellitus %K prediabetes %K self-management %K eHealth %K mobile apps %K evaluation %K diabetes %K digital health %K app %K utilization %K user perception %K user %D 2020 %7 1.12.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Technology-assisted self-management programs are increasingly recommended to patients with long-term conditions such as diabetes. However, there are a number of personal and external factors that affect patients’ abilities to engage with and effectively utilize such programs. A randomized controlled trial of a multi-modal online program for diabetes self-management (BetaMe/Melon) was conducted in a primary care setting, and a process evaluation was completed at the end of the study period. Objective: This process evaluation aimed to examine the utilization patterns of BetaMe/Melon, identify which components participants found most (and least) useful, and identify areas of future improvement. Methods: Process evaluation data were collected for intervention arm participants from 3 sources: (1) the mobile/web platform (to identify key usage patterns over the 16-week core program), (2) an online questionnaire completed during the final study assessment, and (3) interviews conducted with a subset of participants following the study period. Participants were classified as “actively engaged” if any usage data was recorded for the participant (in any week), and patterns were reported by age, gender, ethnicity, and diabetes/prediabetes status. The online questionnaire asked participants about the usefulness of the program and whether they would recommend BetaMe/Melon to others according to a 5-point Likert Scale. Of 23 invited participants, 18 participated in a digitally recorded, semistructured telephone interview. Interview data were thematically analyzed. Results: Out of the 215 participants, 198 (92%) received an initial health coaching session, and 160 (74%) were actively engaged with the program at some point during the 16-week core program. Engagement varied by demographic, with women, younger participants, and ethnic majority populations having higher rates of engagement. Usage steadily declined from 50% at Week 0 to 23% at Week 15. Participants ranked component usefulness as education resources (63.7%), health coaches (59.2%), goal tracking (48.8%), and online peer support (42.1%). Although 53% agreed that the program was easy to use, 64% would recommend the program to others. Interview participants found BetaMe/Melon useful overall, with most identifying beneficial outcomes such as increased knowledge, behavioral changes, and weight loss. Barriers to engagement were program functionality, internet connectivity, incomplete delivery of all program components, and participant motivation. Participants suggested a range of improvements to the BetaMe/Melon program. Conclusions: The program was generally well received by participants; active engagement was initially high, although it declined steadily. Maintaining participant engagement over time, individualizing programs, and addressing technical barriers are important to maximize potential health benefits from online diabetes self-management programs. Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12617000549325; https://tinyurl.com/y622b27q %M 33258776 %R 10.2196/19150 %U https://www.jmir.org/2020/12/e19150 %U https://doi.org/10.2196/19150 %U http://www.ncbi.nlm.nih.gov/pubmed/33258776 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 12 %P e18074 %T Stakeholder Feedback of Electronic Medication Adherence Products: Qualitative Analysis %A Faisal,Sadaf %A Ivo,Jessica %A McDougall,Aidan %A Patel,Tejal %+ School of Pharmacy, University of Waterloo, 10 Victoria St S, Kitchener, ON, N2G 1C5, Canada, 1 519 888 4567 ext 21337, t5patel@uwaterloo.ca %K medication nonadherence %K technology %K aged %K patient preferences %K eHealth %K qualitative research %K adherence %D 2020 %7 1.12.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Medication management among older adults continues to be a challenge, and innovative electronic medication adherence products have been developed to address this need. Objective: The aim of this study is to examine user experience with electronic medication adherence products, with particular emphasis on features, usefulness, and preferences. Methods: Older adults, caregivers, and health care providers tested the usability of 22 electronic medication adherence products. After testing 5 products, participants were invited to participate in a one-on-one interview to investigate their perceptions and experiences with the features, usefulness, and preference for electronic medication adherence products tested. The interviews were audio recorded, transcribed, and analyzed using exploratory inductive coding to generate themes. The first 13 interviews were independently coded by 2 researchers. The percentage agreement and Cohen kappa after analyzing those interviews were 79% and 0.79, respectively. A single researcher analyzed the remaining interviews. Results: Of the 37 participants, 21 (57%) were older adults, 5 (14%) were caregivers, and 11 (30%) were health care providers. The themes and subthemes generated from the qualitative analysis included product factors (subthemes: simplicity and product features, including availability and usability of alarms, portability, restricted access to medications, and storage capacity) and user factors (subthemes: sentiment, affordability, physical and cognitive capability, and technology literacy and learnability). Conclusions: Electronic medication adherence products have the potential to enable independent medication management in older adults. The choice of a particular product should be made after considering individual preferences for product features, affordability, and the sentiment of the users. Older adults, caregivers, and health care providers prefer electronic medication adherence products that are simple to set up and use, are portable, have easy-to-access medication compartments, are secure, and have adequate storage capacity. %M 33258778 %R 10.2196/18074 %U https://www.jmir.org/2020/12/e18074 %U https://doi.org/10.2196/18074 %U http://www.ncbi.nlm.nih.gov/pubmed/33258778 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 3 %N 2 %P e15833 %T Usability of eHealth and Mobile Health Interventions by Young People Living With Juvenile Idiopathic Arthritis: Systematic Review %A Butler,Sonia %A Sculley,Dean %A Santos,Derek Santos %A Fellas,Antoni %A Gironès,Xavier %A Singh-Grewal,Davinder %A Coda,Andrea %+ School of Bioscience and Pharmacy, University of Newcastle, 10 Chittaway Rd, Ourimbah, New South Wales, 2258, Australia, 61 421945914, sonia.butler@newcastle.edu.au %K juvenile idiopathic arthritis %K child %K adolescence %K eHealth %K mHealth %K systematic review %K mobile phone %K pain %K physical activity %K self-management %K quality of life %D 2020 %7 1.12.2020 %9 Review %J JMIR Pediatr Parent %G English %X Background: Considering the changing landscape of internet use and rising ownership of digital technology by young people, new methods could be considered to improve the current model of juvenile idiopathic arthritis (JIA) management. Objective: This systematic review aims to evaluate the usability of eHealth and mobile health (mHealth) interventions currently available for young people living with JIA. Methods: The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used to oversee this review. We systematically searched 15 databases for 252 potential studies; 2 authors independently screened all quantitative studies reporting the use of eHealth and mHealth interventions for young people (aged 1-18 years) diagnosed with JIA. Studies were excluded if they did not report outcome measures or were reviews, commentaries, or qualitative studies. Study methodological quality was scored using the Down and Black (modified) checklist. A narrative descriptive methodology was used to quantify the data because of heterogeneity across the studies. Results: A total of 11 studies were included in this review, reporting 7 eHealth and mHealth interventions for young people (aged 4-18 years) living with JIA, targeting health issues such as pain, health-related quality of life, physical activity, and chronic disease self-management. The usability of the interventions was facilitated through training and ongoing support. The engagement was promoted by a combination of persuasive influences, and barriers preventing adherence were removed through personal reminders and flexible program schedules to cater to JIA and non-JIA illnesses or other commonly seen activities in childhood. The feedback obtained was that most young people and their parents liked the interventions. Conclusions: The results of this review need to be considered cautiously because of the lack of rigorous testing and heterogeneity, which limits the detailed descriptions of data synthesis. Further research is needed to consider gender differences, associated costs, and the effectiveness of the interventions on health outcomes to better support young people living with JIA. %M 33258786 %R 10.2196/15833 %U http://pediatrics.jmir.org/2020/2/e15833/ %U https://doi.org/10.2196/15833 %U http://www.ncbi.nlm.nih.gov/pubmed/33258786 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 12 %P e16729 %T A Web-Based Mental Health Intervention to Improve Social and Occupational Functioning in Adults With Type 2 Diabetes (The Springboard Trial): 12-Month Outcomes of a Randomized Controlled Trial %A Baldwin,Peter Andrew %A Sanatkar,Samineh %A Clarke,Janine %A Fletcher,Susan %A Gunn,Jane %A Wilhelm,Kay %A Campbell,Lesley %A Zwar,Nicholas %A Harris,Mark %A Lapsley,Helen %A Hadzi-Pavlovic,Dusan %A Christensen,Helen %A Proudfoot,Judy %+ Black Dog Institute, Hospital Road, Randwick, 2031, Australia, 61 0293824521, p.baldwin@unsw.edu.au %K type 2 diabetes %K depression %K internet %D 2020 %7 1.12.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: People with type 2 diabetes mellitus (T2DM) often experience mental health symptoms that exacerbate illness and increase mortality risk. Access to psychological support is low in people with T2DM. Detection of depression is variable in primary care and can be further hampered by mental health stigma. Electronic mental health (eMH) programs may provide an accessible, private, nonstigmatizing mental health solution for this group. Objective: This study aims to evaluate the efficacy over 12 months of follow-up of an eMH program (myCompass) for improving social and occupational functioning in a community sample of people with T2DM and self-reported mild-to-moderate depressive symptoms. myCompass is a fully automated and self-guided web-based public health program for people with depression or anxiety. The effects of myCompass on depressive symptoms, diabetes-related distress, anxiety symptoms, and self-care behavior were also examined. Methods: Adults with T2DM and mild-to-moderate depressive symptoms (N=780) were recruited via online advertisements, community organizations, and general practices. Screening, consent, and self-report questionnaires were administered online. Eligible participants were randomized to receive either myCompass (n=391) or an attention control generic health literacy program (Healthy Lifestyles; n=379) for 8 weeks. At baseline and at 3, 6, and 12 months postintervention, participants completed the Work and Social Adjustment Scale, the Patient Health Questionnaire-9 item, the Diabetes Distress Scale, the Generalized Anxiety Disorder Questionnaire-7 item, and items from the Self-Management Profile for Type 2 Diabetes. Glycosylated hemoglobin measurements were obtained at baseline and 6 and 12 months postintervention. Results: A total of 38.9% (304/780) of the trial participants completed all postintervention assessments. myCompass users logged in on an average of 6 times and completed an average of 0.29 modules. Healthy Lifestyles users logged in on an average of 4 times and completed an average of 1.37 modules. At baseline, the mean scores on several outcome measures, including the primary outcome of work and social functioning, were close to the normal range, despite a varied and extensive recruitment process. Intention-to-treat analyses revealed slightly greater improvement at 12 months in work and social functioning for the Healthy Lifestyles group relative to the myCompass group. All participants reported equivalent improvements in depression anxiety, diabetes distress, diabetes self-management, and glycemic control across the trial. Conclusions: The Healthy Lifestyles group reported higher ratings of social and occupational functioning than the myCompass group, but no differences were observed for any secondary outcome. Although these findings should be interpreted in light of the near-floor symptom scores at baseline, the trial yields important insights into how people with T2DM might be engaged in eMH programs and the challenges of focusing specifically on mental health. Several avenues emerge for continued investigation into how best to deal with the growing mental health burden in adults with T2DM. Trial Registration: Australian New Zealand Clinical Trials Registry Number (ACTRN) 12615000931572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368109&isReview=true %M 33258790 %R 10.2196/16729 %U https://www.jmir.org/2020/12/e16729 %U https://doi.org/10.2196/16729 %U http://www.ncbi.nlm.nih.gov/pubmed/33258790 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 12 %P e22634 %T Screening for Depression in Daily Life: Development and External Validation of a Prediction Model Based on Actigraphy and Experience Sampling Method %A Minaeva,Olga %A Riese,Harriëtte %A Lamers,Femke %A Antypa,Niki %A Wichers,Marieke %A Booij,Sanne H %+ Interdisciplinary Center Psychopathology and Emotion regulation (ICPE), Department of Psychiatry, University Medical Center Groningen, University of Groningen, Hanzeplein 1, Groningen, 9713 GZ, Netherlands, 31 50 361 2065, o.minaeva@umcg.nl %K actigraphy %K activity tracker %K depression %K experience sampling method %K prediction model %K screening %D 2020 %7 1.12.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: In many countries, depressed individuals often first visit primary care settings for consultation, but a considerable number of clinically depressed patients remain unidentified. Introducing additional screening tools may facilitate the diagnostic process. Objective: This study aimed to examine whether experience sampling method (ESM)-based measures of depressive affect and behaviors can discriminate depressed from nondepressed individuals. In addition, the added value of actigraphy-based measures was examined. Methods: We used data from 2 samples to develop and validate prediction models. The development data set included 14 days of ESM and continuous actigraphy of currently depressed (n=43) and nondepressed individuals (n=82). The validation data set included 30 days of ESM and continuous actigraphy of currently depressed (n=27) and nondepressed individuals (n=27). Backward stepwise logistic regression analysis was applied to build the prediction models. Performance of the models was assessed with goodness-of-fit indices, calibration curves, and discriminative ability (area under the receiver operating characteristic curve [AUC]). Results: In the development data set, the discriminative ability was good for the actigraphy model (AUC=0.790) and excellent for both the ESM (AUC=0.991) and the combined-domains model (AUC=0.993). In the validation data set, the discriminative ability was reasonable for the actigraphy model (AUC=0.648) and excellent for both the ESM (AUC=0.891) and the combined-domains model (AUC=0.892). Conclusions: ESM is a good diagnostic predictor and is easy to calculate, and it therefore holds promise for implementation in clinical practice. Actigraphy shows no added value to ESM as a diagnostic predictor but might still be useful when ESM use is restricted. %M 33258783 %R 10.2196/22634 %U https://www.jmir.org/2020/12/e22634 %U https://doi.org/10.2196/22634 %U http://www.ncbi.nlm.nih.gov/pubmed/33258783 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 12 %P e22631 %T Mobile Texting and Lay Health Supporters to Improve Schizophrenia Care in a Resource-Poor Community in Rural China (LEAN Trial): Randomized Controlled Trial Extended Implementation %A Cai,Yiyuan %A Gong,Wenjie %A He,Hua %A Hughes,James P %A Simoni,Jane %A Xiao,Shuiyuan %A Gloyd,Stephen %A Lin,Meijuan %A Deng,Xinlei %A Liang,Zichao %A He,Wenjun %A Dai,Bofeng %A Liao,Jing %A Hao,Yuantao %A Xu,Dong (Roman) %+ School of Public Health, Sun Yat-sen University, No 74 Zhongshan Road 2, Yuexiu District, Guangzhou, China, 86 020 87335523, haoyt@mail.sysu.edu.cn %K medication adherence %K mobile texting %K lay health worker %K resource-poor community %K primary health care %K quality of care %K mHealth %K schizophrenia %D 2020 %7 1.12.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Schizophrenia is a severe and disabling condition that presents a dire health equity challenge. Our initial 6-month trial (previously reported) using mobile texting and lay health supporters, called LEAN, significantly improved medication adherence from 0.48 to 0.61 (adjusted mean 0.11, 95% CI 0.03 to 0.20, P=.007) for adults with schizophrenia living in a resource-poor village in rural China. Objective: We explored the effectiveness of our texting program in improving participants’ medication adherence, functioning, and symptoms in an extended implementation of the intervention after its initial phase. Methods: In an approximated stepped-wedge wait-list design randomized controlled trial, 277 community-dwelling villagers with schizophrenia were assigned 1:1 in phase 1 into intervention and wait-list control groups. The intervention group received (1) lay health supporters (medication or care supervisors), (2) e-platform (mobile-texting reminders and education message) access, (3) a token gift for positive behavioral changes, and (4) integration with the existing government community-mental health program (the 686 Program) while the wait-listed control group initially only received the 686 Program. Subsequently (in the extended period), both groups received the LEAN intervention plus the 686 Program. The primary outcome was antipsychotic medication adherence (percentage of dosages taken over the past month assessed by unannounced home-based pill counts). The secondary outcomes were symptoms measured during visits to 686 Program psychiatrists using the Clinical Global Impression scale for schizophrenia and functioning measured by trained student assessors using the World Health Organization Disability Assessment Schedule 2.0. Other outcomes included data routinely collected in the 686 Program system (refill records, rehospitalization due to schizophrenia, death for any reason, suicide, wandering, and violent behaviors). We used intention-to-treat analysis and missing data were imputed. A generalized estimating equation model was used to assess program effects on antipsychotics medication adherence, symptoms, and functioning. Results: Antipsychotics medication adherence improved from 0.48 in the control period to 0.58 in the extended intervention period (adjusted mean difference 0.11, 95% CI 0.04 to 0.19; P=.004). We also noted an improvement in symptoms (adjusted mean difference –0.26, 95% CI –0.50 to –0.02; P=.04; Cohen d effect size 0.20) and a reduction in rehospitalization (0.37, 95% CI 0.18 to 0.76; P=.007; number-needed-to-treat 8.05, 95% CI 4.61 to 21.41). There was no improvement in functioning (adjusted mean difference 0.02, 95% CI –0.01 to 0.06; P=.18; Cohen d effect size 0.04). Conclusions: In an extended implementation, our intervention featuring mobile texting messages and lay health workers in a resource-poor community setting was more effective than the 686 Program alone in improving medication adherence, improving symptoms, and reducing rehospitalization. Trial Registration: Chinese Clinical Trial Registry; ChiCTR-ICR-15006053 https://tinyurl.com/y5hk8vng %M 33258788 %R 10.2196/22631 %U https://www.jmir.org/2020/12/e22631 %U https://doi.org/10.2196/22631 %U http://www.ncbi.nlm.nih.gov/pubmed/33258788 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 11 %P e21066 %T Adaptive Elements in Internet-Delivered Psychological Treatment Systems: Systematic Review %A Mukhiya,Suresh Kumar %A Wake,Jo Dugstad %A Inal,Yavuz %A Pun,Ka I %A Lamo,Yngve %+ Western Norway University of Applied Sciences, Inndalsveien 28, Bergen, 5063, Norway, 47 55 58 58 00, skmu@hvl.no %K cognitive behavioural therapy %K internet-delivered psychological treatment %K adaptive treatment %K internet-based treatment %K adaptive system %K mental health %K literature review %K architecture centric development %K tailored internet interventions %K flexible mHealth internet interventions %D 2020 %7 27.11.2020 %9 Review %J J Med Internet Res %G English %X Background: Internet-delivered psychological treatments (IDPTs) are built on evidence-based psychological treatment models, such as cognitive behavioral therapy, and are adjusted for internet use. The use of internet technologies has the potential to increase access to evidence-based mental health services for a larger proportion of the population with the use of fewer resources. However, despite extensive evidence that internet interventions can be effective in the treatment of mental health disorders, user adherence to such internet intervention is suboptimal. Objective: This review aimed to (1) inspect and identify the adaptive elements of IDPT for mental health disorders, (2) examine how system adaptation influences the efficacy of IDPT on mental health treatments, (3) identify the information architecture, adaptive dimensions, and strategies for implementing these interventions for mental illness, and (4) use the findings to create a conceptual framework that provides better user adherence and adaptiveness in IDPT for mental health issues. Methods: The review followed the guidelines from Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The research databases Medline (PubMed), ACM Digital Library, PsycINFO, CINAHL, and Cochrane were searched for studies dating from January 2000 to January 2020. Based on predetermined selection criteria, data from eligible studies were analyzed. Results: A total of 3341 studies were initially identified based on the inclusion criteria. Following a review of the title, abstract, and full text, 31 studies that fulfilled the inclusion criteria were selected, most of which described attempts to tailor interventions for mental health disorders. The most common adaptive elements were feedback messages to patients from therapists and intervention content. However, how these elements contribute to the efficacy of IDPT in mental health were not reported. The most common information architecture used by studies was tunnel-based, although a number of studies did not report the choice of information architecture used. Rule-based strategies were the most common adaptive strategies used by these studies. All of the studies were broadly grouped into two adaptive dimensions based on user preferences or using performance measures, such as psychometric tests. Conclusions:  Several studies suggest that adaptive IDPT has the potential to enhance intervention outcomes and increase user adherence. There is a lack of studies reporting design elements, adaptive elements, and adaptive strategies in IDPT systems. Hence, focused research on adaptive IDPT systems and clinical trials to assess their effectiveness are needed. %M 33245285 %R 10.2196/21066 %U http://www.jmir.org/2020/11/e21066/ %U https://doi.org/10.2196/21066 %U http://www.ncbi.nlm.nih.gov/pubmed/33245285 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 11 %P e19391 %T Scientific Publication Patterns of Mobile Technologies and Apps for Posttraumatic Stress Disorder Treatment: Bibliometric Co-Word Analysis %A Kulakli,Atik %A Shubina,Ivanna %+ Department of Management Information Systems, College of Business Administration, American University of the Middle East, Block 6, Building 1, Egaila, 54200, Kuwait, 965 22251400, atik.kulakli@aum.edu.kw %K posttraumatic stress disorder (PTSD) %K mobile technologies %K mobile apps %K treatment %K text analysis %K co-word analysis %K bibliometric %K Web of Science %D 2020 %7 26.11.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mobile apps are viewed as a promising opportunity to provide support for patients who have posttraumatic stress disorder (PTSD). The development of mobile technologies and apps shows similar trends in PTSD treatment. Therefore, this emerging research field has received substantial attention. Consequently, various research settings are planned for current and further studies. Objective: The aim of this study was to explore the scientific patterns of research domains related to mobile apps and other technologies for PTSD treatment in scholarly publications, and to suggest further studies for this emerging research field. Methods: We conducted a bibliometric analysis to identify publication patterns, most important keywords, trends for topicality, and text analysis, along with construction of a word cloud for papers published in the last decade (2010 to 2019). Research questions were formulated based on the relevant literature. In particular, we concentrated on highly ranked sources. Based on the proven bibliometric approach, the data were ultimately retrieved from the Web of Science Core Collection (Clarivate Analytics). Results: A total of 64 studies were found concerning the research domains. The vast majority of the papers were written in the English language (63/64, 98%) with the remaining article (1/64, 2%) written in French. The articles were written by 323 authors/coauthors from 11 different countries, with the United States predominating, followed by England, Canada, Italy, the Netherlands, Australia, France, Germany, Mexico, Sweden, and Vietnam. The most common publication type was peer-reviewed journal articles (48/64, 75%), followed by reviews (8/64, 13%), meeting abstracts (5/64, 8%), news items (2/64, 3%), and a proceeding (1/64, 2%). There was a mean of 6.4 papers published per year over the study period. There was a 100% increase in the number of publications published from 2016 to 2019 with a mean of 13.33 papers published per year during this latter period. Conclusions: Although the number of papers on mobile technologies for PTSD was quite low in the early period, there has been an overall increase in this research domain in recent years (2016-2019). Overall, these findings indicate that mobile health tools in combination with traditional treatment for mental disorders among veterans increase the efficiency of health interventions, including reducing PTSD symptoms, improving quality of life, conducting intervention evaluation, and monitoring of improvements. Mobile apps and technologies can be used as supportive tools in managing pain, anger, stress, and sleep disturbance. These findings therefore provide a useful overview of the publication trends on research domains that can inform further studies and highlight potential gaps in this field. %M 33242019 %R 10.2196/19391 %U http://mhealth.jmir.org/2020/11/e19391/ %U https://doi.org/10.2196/19391 %U http://www.ncbi.nlm.nih.gov/pubmed/33242019 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 11 %P e18364 %T Gamified Text Messaging Contingent on Device-Measured Steps: Randomized Feasibility Study of a Physical Activity Intervention for Cancer Survivors %A Robertson,Michael C %A Lyons,Elizabeth J %A Liao,Yue %A Baum,Miranda L %A Basen-Engquist,Karen M %+ Department of Behavioral Science, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, United States, 1 713 745 3123, kbasenen@mdanderson.org %K cancer survivors %K physical activity %K motivation %K self-control %K mobile health %K mobile phone %K technology %D 2020 %7 24.11.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Physical activity can confer diverse benefits on cancer survivors. Unfortunately, many cancer survivors are not sufficiently active. The efficacy of physical activity interventions for this population may be increased by grounding them in Self-Determination Theory (SDT). Combining game design elements with wearable technologies may be a useful and scalable approach to targeting SDT constructs to promote cancer survivors’ physical activity. Objective: The primary aim of this study is to evaluate the feasibility and acceptability of Steps2Health, a physical activity intervention for cancer survivors. It also aims to investigate the effects of the intervention on motivation, physical activity, and step count. Methods: We randomized 78 insufficiently active cancer survivors to an experimental or comparison group. All participants received a physical activity tracker. The experimental group participants also received a set sequence of multimedia messaging service messages that were triggered in real time by meeting predetermined cumulative step count totals. Messages presented information about a virtual journey and included photographs and vivid descriptions of locations to increase autonomous motivation. Additional messages targeted perceptions of relatedness (eg, role modeling) and competence (eg, facilitating mastery experiences). We administered pre- and postintervention surveys and conducted 15 individual interviews to evaluate the intervention. We performed directed content analysis of qualitative data and conducted mixed effects linear modeling to investigate participants’ changes in motivation, self-reported physical activity, and device-measured step counts. Results: There was minimal loss to follow-up (3/78, 4%), the device wear rate was high (2548/3044, 83.71% of days), and technical problems with messaging based on real-time step counts were limited. Our qualitative data analysis revealed 3 overarching themes: accessibility, autonomous motivation, and relatedness. Participants successfully navigated the technological aspects and game design elements of the intervention. Participants found messages targeting autonomous motivation and competence or self-efficacy to be enjoyable and compelling, but one feasibility criterion for participant engagement (response rate to text messages) was not met. Messages targeting relatedness were less highly rated than the messages targeting autonomous motivation and competence or self-efficacy. During the intervention, both groups increased their motivation for physical activity (B=0.16; 95% CI 0.01 to 0.30; P=.04; d=0.49), and assignment to the experimental group was associated with increased self-reported leisure activity score (B=10.78; 95% CI 3.54 to 18.02; P=.005; d=0.64). The experimental group had greater increases in daily step counts over time (B=322.08; 95% CI 54.01 to 590.15; P=.02; d=0.28). Conclusions: This study supports the feasibility of using real-time game design elements to target SDT constructs and increase cancer survivors’ physical activity. Overall, our findings support the acceptability of the Steps2Health intervention, but fostering active participant engagement and targeting relatedness may present additional challenges. Steps2Health may help cancer survivors increase their physical activity levels. %M 33231551 %R 10.2196/18364 %U https://mhealth.jmir.org/2020/11/e18364 %U https://doi.org/10.2196/18364 %U http://www.ncbi.nlm.nih.gov/pubmed/33231551 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 11 %P e18104 %T Importance of Multiple Reinforcing Comments and Areas for Change in Optimizing Dietary and Exercise Self-Monitoring Feedback in Behavioral Weight Loss Programs: Factorial Design %A Krukowski,Rebecca %A Kim,Hyeonju %A Stansbury,Melissa %A Li,Qian %A Sen,Saunak %A Farage,Gregory %A West,Delia %+ Department of Preventive Medicine, College of Medicine, University of Tennessee Health Science Center, 66 N. Pauline, Memphis, TN, 38163, United States, 1 9014482426, rkrukows@uthsc.edu %K overweight %K obesity %K weight loss %K feedback %K diet records %K compliance %K counselor %D 2020 %7 23.11.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Individualized dietary and physical activity self-monitoring feedback is a core element of behavioral weight loss interventions and is associated with clinically significant weight loss. To our knowledge, no studies have evaluated individuals’ perspectives on the composition of feedback messages or the effect of feedback composition on the motivation to self-monitor. Objective: This study aims to assess the perceptions of feedback emails as a function of the number of comments that reinforce healthy behavior and the number of areas for change (ie, behavioral changes that the individual might make to have an impact on weight) identified. Methods: Emailed feedback followed a factorial design with 2 factors (ie, reinforcing comments and areas for change), each with 3 levels (ie, 1, 4, or 8 comments). A total of 250 adults with overweight or obesity who were interested in weight loss were recruited from the Qualtrics research panel. Participants read 9 emails presented in a random order. For each email, respondents answered 8 questions about the likelihood to self-monitor in the future, motivation for behavioral change, and perceptions of the counselor and the email. A mixed effects ordinal logistic model was used to compute conditional odds ratios and predictive margins (ie, average predicted probability) on a 5-point Likert response scale to investigate the optimal combination level of the 2 factors. Results: Emails with more reinforcing comments or areas for change were better received, with small incremental benefits for 8 reinforcing comments or areas for change versus 4 reinforcing comments or areas for change. Interactions indicated that the best combination for 3 of 8 outcomes assessed (ie, motivation to make behavioral changes, counselor’s concern for their welfare, and the perception that the counselor likes them) was the email with 8 reinforcing comments and 4 areas for change. Emails with 4 reinforcing comments and 4 areas for change resulted in the highest average probability of individuals who reported being very likely to self-monitor in the future. Conclusions: The study findings suggest how feedback might be optimized for efficacy. Future studies should explore whether the composition of feedback email affects actual self-monitoring performance. %M 33226348 %R 10.2196/18104 %U https://www.jmir.org/2020/11/e18104 %U https://doi.org/10.2196/18104 %U http://www.ncbi.nlm.nih.gov/pubmed/33226348 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 11 %P e19570 %T Pre-Conception Interventions for Subfertile Couples Undergoing Assisted Reproductive Technology Treatment: Modeling Analysis %A Steegers-Theunissen,Régine %A Hoek,Annemieke %A Groen,Henk %A Bos,Annelies %A van den Dool,Grada %A Schoonenberg,Marieke %A Smeenk,Jesper %A Creutzberg,Eva %A Vecht,Loes %A Starmans,Luc %A Laven,Joop %+ Department of Obstetrics and Gynaecology, Erasmus MC, University Medical Center, Office EE-2271a, Dr.Molewaterplein 40, 3015 GD, Rotterdam, Netherlands, 31 107038255, r.steegers@erasmusmc.nl %K fertility, periconception, pregnancy chance, Smarter Pregnancy, cost-effectiveness, nutrition, obesity, IVF treatment %K mobile and web-based lifestyle apps %D 2020 %7 23.11.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Approximately 1 in 7 couples experience subfertility, many of whom have lifestyles that negatively affect fertility, such as poor nutrition, low physical activity, obesity, smoking, or alcohol consumption. Reducing lifestyle risk factors prior to pregnancy or assisted reproductive technology treatment contributes to the improvement of reproductive health, but cost-implications are unknown. Objective: The goal of this study was to evaluate reproductive, maternal pregnancy, and birth outcomes, as well as the costs of pre-conception lifestyle intervention programs in subfertile couples and obese women undergoing assisted reproductive technology. Methods: Using a hypothetical model based on quantitative parameters from published literature and expert opinion, we evaluated the following lifestyle intervention programs: (1) Smarter Pregnancy, an online tool; (2) LIFEstyle, which provides outpatient support for obese women; (3) concurrent use of both Smarter Pregnancy and LIFEstyle for obese women; (4) smoking cessation in men; and (5) a mindfulness mental health support program using group therapy sessions. The model population was based on data from the Netherlands. Results: All model-based analyses of the lifestyle interventions showed a reduction in the number of in vitro fertilization, intracytoplasmic sperm injection, or intrauterine insemination treatments required to achieve pregnancy and successful birth for couples in the Netherlands. Smarter Pregnancy was modeled to have the largest increase in spontaneous pregnancy rate (13.0%) and the largest absolute reduction in potential assisted reproductive technology treatments. Among obese subfertile women, LIFEstyle was modeled to show a reduction in the occurrence of gestational diabetes, maternal hypertensive pregnancy complications, and preterm births by 4.4%, 3.8%, and 3.0%, respectively, per couple. Modeled cost savings per couple per year were €41 (US $48.66), €360 (US $427.23), €513 (US $608.80), €586 (US $695.43), and €1163 (US $1380.18) for smoking cessation, mindfulness, Smarter Pregnancy, combined Smarter Pregnancy AND LIFEstyle, and LIFEstyle interventions, respectively. Conclusions: Although we modeled the potential impact on reproductive outcomes and costs of fertility treatment rather than collecting real-world data, our model suggests that of the lifestyle interventions for encouraging healthier behaviors, all are likely to be cost effective and appear to have positive effects on reproductive, maternal pregnancy, and birth outcomes. Further real-world data are required to determine the cost-effectiveness of pre-conception lifestyle interventions, including mobile apps and web-based tools that help improve lifestyle, and their effects on reproductive health. We believe that further implementation of the lifestyle app Smarter Pregnancy designed for subfertile couples seeking assistance to become pregnant is likely to be cost-effective and would allow reproductive health outcomes to be collected. %M 33226349 %R 10.2196/19570 %U https://mhealth.jmir.org/2020/11/e19570 %U https://doi.org/10.2196/19570 %U http://www.ncbi.nlm.nih.gov/pubmed/33226349 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 11 %P e18826 %T Engagement With a Web-Based Intervention to Reduce Harmful Drinking: Secondary Analysis of a Randomized Controlled Trial %A Nordholt,Paul U %A Christalle,Eva %A Zill,Jördis M %A Dirmaier,Jörg %+ Institute and Outpatient Clinic of Medical Psychology, University Medical Center Hamburg-Eppendorf, Department of Medical Psychology, Martinistr 52, Hamburg, 20246, Germany, 49 407410 ext 59137, dirmaier@uke.de %K engagement %K usage %K alcohol %K eHealth %K mHealth %K readiness to change %K self-efficacy %K outcome expectancy %D 2020 %7 20.11.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Engagement with digital behavior change interventions (DBCIs) is considered a prerequisite for intervention efficacy. However, in many trials on DBCIs, participants use the intervention either only little or not at all. Objective: To analyze engagement with a web-based intervention to reduce harmful drinking, we explored (1) whether engagement with a web-based alcohol intervention is related to drinking outcomes, (2) which user characteristics are associated with measures of engagement, and (3) whether reported outcomes are associated with data captured by voluntary intervention questionnaires. Methods: We analyzed data of the intervention arm of a randomized controlled trial on a DBCI to reduce risky alcohol consumption. Data were collected at baseline (T0), after 90 days (T1), and at the end of the 180-day usage period (T2). Engagement with the intervention was measured via system usage data as well as self-reported usage. Drinking behavior was measured as average daily alcohol consumption as well as the number of binge drinking days. User characteristics included demographics, baseline drinking behavior, readiness to change, alcohol-related outcome expectancies, and alcohol abstinence self-efficacy. Following a bivariate approach, we performed two-tailed Welch’s t tests and Wilcoxon signed rank/Mann-Whitney U tests or calculated correlation coefficients. Results: The data of 306 users were analyzed. Time spent engaging with the intervention as measured by system usage did not match self-reported usage. Higher self-reported usage was associated with higher reductions in average daily alcohol consumption (T1: ρ=0.39, P<.001; T2: ρ=0.29, P=.015) and in binge drinking days (T1: ρ=0.62, P<.001; T2: ρ=0.3, P=.006). Higher usage was reported from users who were single (T1: P<.001; T2: P<.001), users without children (T1: P<.001; T2: P<.001), users who did not start or finish secondary education (T1: P<.001; T2: P<.001), users without academic education (T1: P<.001; T2: P<.001), and those who worked (T1: P=.001; T2: P=.004). Relationships between self-reported usage and clinical or psychological baseline characteristics were complex. For system usage, the findings were mixed. Reductions in drinking captured by intervention questionnaires were associated with reported outcomes. Conclusions: Though self-reported usage could be consistently linked to better outcomes and multiple user characteristics, our findings add to the overall inconclusive evidence that can be found throughout the literature. Our findings indicate potential benefits of self-reports as measures of engagement and intervention questionnaires as a basis for tailoring of intervention content. Future studies should adopt a theory-driven approach to engagement research utilizing psychometrically sound self-report questionnaires and include short ecological momentary assessments within the DBCIs. Trial Registration: German Clinical Trials Register DRKS00006104; https://tinyurl.com/y22oc5jo %M 33216008 %R 10.2196/18826 %U https://www.jmir.org/2020/11/e18826 %U https://doi.org/10.2196/18826 %U http://www.ncbi.nlm.nih.gov/pubmed/33216008 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 11 %P e18691 %T Patients’ Experiences of Telephone-Based and Web-Based Cognitive Behavioral Therapy for Irritable Bowel Syndrome: Longitudinal Qualitative Study %A Hughes,Stephanie %A Sibelli,Alice %A Everitt,Hazel A %A Moss-Morris,Rona %A Chalder,Trudie %A Harvey,J Matthew %A Vas Falcao,Andrea %A Landau,Sabine %A O'Reilly,Gilly %A Windgassen,Sula %A Holland,Rachel %A Little,Paul %A McCrone,Paul %A Goldsmith,Kimberley %A Coleman,Nicholas %A Logan,Robert %A Bishop,Felicity L %+ Centre for Clinical and Community Applications of Health Psychology, Department of Psychology, University of Southampton, Department of Psychology (B44), Highfield Campus, Southampton, SO17 1BJ, United Kingdom, 44 2380599020, f.l.bishop@southampton.ac.uk %K irritable bowel syndrome %K cognitive behavioral therapy %K internet %K primary health care %K self-management %D 2020 %7 20.11.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Cognitive behavioral therapy (CBT) is recommended in guidelines for people with refractory irritable bowel syndrome (IBS). However, the availability of CBT is limited, and poor adherence has been reported in face-to-face CBT. Objective: Nested within a randomized controlled trial of telephone- and web-delivered CBT for refractory IBS, this qualitative study aims to identify barriers to and facilitators of engagement over time with the interventions, identify social and psychological processes of change, and provide insight into trial results. Methods: A longitudinal qualitative study was nested in a randomized controlled trial. Repeated semistructured interviews were conducted at 3 (n=34) and 12 months (n=25) post baseline. Participants received telephone-based CBT (TCBT; n=17 at 3 months and n=13 at 12 months) or web-based CBT (WCBT; n=17 at 3 months and n=12 at 12 months). Inductive thematic analysis was used to analyze the data. Results: Participants viewed CBT as credible for IBS, perceived their therapists as knowledgeable and supportive, and liked the flexibility of web-based and telephone-based delivery; these factors facilitated engagement. Potential barriers to engagement in both groups (mostly overcome by our participants) included initial skepticism and concerns about the biopsychosocial nature of CBT, initial concerns about telephone-delivered talking therapy, challenges of maintaining motivation and self-discipline given already busy lives, and finding nothing new in the WCBT (WCBT group only). Participants described helpful changes in their understanding of IBS, attitudes toward IBS, ability to recognize IBS patterns, and IBS-related behaviors. Consistent with the trial results, participants described lasting positive effects on their symptoms, work, and social lives. Reasons and remedies for some attenuation of effects were identified. Conclusions: Both TCBT and WCBT for IBS were positively received and had lasting positive impacts on participants’ understanding of IBS, IBS-related behaviors, symptoms, and quality of life. These forms of CBT may broaden access to CBT for IBS. %M 33216002 %R 10.2196/18691 %U https://www.jmir.org/2020/11/e18691 %U https://doi.org/10.2196/18691 %U http://www.ncbi.nlm.nih.gov/pubmed/33216002 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 7 %N 11 %P e15149 %T Health Personnel’s Perceived Usefulness of Internet-Based Interventions for Parents of Children Younger Than 5 Years: Cross-Sectional Web-Based Survey Study %A Størksen,Hege Therese %A Haga,Silje Marie %A Slinning,Kari %A Drozd,Filip %+ Department for Infant Mental Health, Regional Centre for Child and Adolescent Mental Health, Eastern and Southern Norway, Gullhaugveien 1-3, Oslo, 0484, Norway, 47 95972822, hege.storksen@r-bup.no %K internet %K parent support %K children %K mental health %K acceptability %K health care services %D 2020 %7 18.11.2020 %9 Original Paper %J JMIR Ment Health %G English %X Background: Approximately 10%-15% of children struggle with different socioemotional and psychological difficulties in infancy and early childhood. Thus, health service providers should have access to mental health interventions that can reach more parents than traditional face-to-face interventions. However, despite increasing evidence on the efficacy of internet-based mental health interventions, the pace in transferring such interventions to health care has been slow. One of the major suggested barriers to this may be the health personnel’s attitudes to perceived usefulness of internet-based interventions. Objective: The purpose of this study was to examine health professionals’ perceived usefulness of internet-based mental health interventions and to identify the key areas that they consider new internet-based services to be useful. Methods: Between May and September 2018, 2884 leaders and practitioners of infant and child health services were recruited to a cross-sectional web-based survey through the following channels: (1) existing email addresses from the Regional Centre for Child and Adolescent Mental Health, Eastern and Southern Norway, course database, (2) an official mailing list to infant and child health services, (3) social media, or (4) other recruitment channels. Respondents filled in background information and were asked to rate the usefulness of internet-based interventions for 12 different infant and child mental health problem areas based on the broad categories from the Diagnostic Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood (DC:0-5). Perceived usefulness was assessed with 1 global item: “How often do you think internet-based self-help programs can be useful for following infant and child mental health problems in your line of work?” The answers were scored on a 4-point scale ranging from 0 (never) to 3 (often). Results: The participants reported that they sometimes or often perceived internet-based interventions as useful for different infant and child mental health problems (scale of 0-3, all means>1.61). Usefulness of internet-based interventions was rated acceptable for sleep problems (mean 2.22), anxiety (mean 2.09), and social withdrawal and shyness (mean 2.07), whereas internet-based interventions were rated as less useful for psychiatric problems such as obsessive behaviors (mean 1.89), developmental disorders (mean 1.91), or trauma (mean 1.61). Further, there were a few but small differences in perceived usefulness between service leaders and practitioners (all effect sizes<0.32, all P<.02) and small-to-moderate differences among daycare centers, well-baby clinics, municipal child welfare services, and child and adolescent mental health clinics (all effect sizes<0.69, all P<.006). Conclusions: Internet-based interventions for different infant and child mental health problems within services such as daycare centers, well-baby clinics, municipal child welfare services, and child and adolescent mental health clinics are sometimes or often perceived as useful. These encouraging findings can support the continued exploration of internet-based mental health interventions as a way to improve parental support. %M 33206058 %R 10.2196/15149 %U http://mental.jmir.org/2020/11/e15149/ %U https://doi.org/10.2196/15149 %U http://www.ncbi.nlm.nih.gov/pubmed/33206058 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 11 %P e20709 %T Mindfulness-Based Programs for Patients With Cancer via eHealth and Mobile Health: Systematic Review and Synthesis of Quantitative Research %A Matis,Juraj %A Svetlak,Miroslav %A Slezackova,Alena %A Svoboda,Marek %A Šumec,Rastislav %+ Department of Psychology and Psychosomatics, Faculty of Medicine, Masaryk University, Kamenice 126/3, Brno, +42062500, Czech Republic, 420 773111330, msvetlak@med.muni.cz %K eHealth %K mHealth %K mindfulness %K cancer %K systematic review %K mobile phone %D 2020 %7 16.11.2020 %9 Review %J J Med Internet Res %G English %X Background: eHealth mindfulness-based programs (eMBPs) are on the rise in complex oncology and palliative care. However, we are still at the beginning of answering the questions of how effective eMBPs are and for whom, and what kinds of delivery modes are the most efficient. Objective: This systematic review aims to examine the feasibility and efficacy of eMBPs in improving the mental health and well-being of patients with cancer, to describe intervention characteristics and delivery modes of these programs, and to summarize the results of the included studies in terms of moderators, mediators, and predictors of efficacy, adherence, and attrition. Methods: In total, 4 databases (PubMed, PsycINFO, Scopus, and Web of Knowledge) were searched using relevant search terms (eg, mindfulness, program, eHealth, neoplasm) and their variations. No restrictions were imposed on language or publication type. The results of the efficacy of eMBPs were synthesized through the summarizing effect estimates method. Results: A total of 29 published papers describing 24 original studies were included in this review. In general, the results indicate that eMBPs have the potential to reduce the levels of stress, anxiety, depression, fatigue, sleep problems, and pain, and improve the levels of mindfulness, posttraumatic growth, and some parameters of general health. The largest median of Cohen d effect sizes were observed in reducing anxiety and depression (within-subject: median −0.38, IQR −0.62 to −0.27; between-group: median −0.42, IQR −0.58 to −0.22) and facilitating posttraumatic growth (within-subject: median 0.42, IQR 0.35 to 0.48; between-group: median 0.32, IQR 0.22 to 0.39). The efficacy of eMBP may be comparable with that of parallel, face-to-face MBPs in some cases. All studies that evaluated the feasibility of eMBPs reported that they are feasible for patients with cancer. Potential moderators, mediators, and predictors of the efficacy, attrition, and adherence of eMBPs are discussed. Conclusions: Although the effects of the reviewed studies were highly heterogeneous, the review provides evidence that eMBPs are an appropriate way for mindfulness practice to be delivered to patients with cancer. Thus far, existing eMBPs have mostly attempted to convert proven face-to-face mindfulness programs to the eHealth mode. They have not yet fully exploited the potential of eHealth technology. %M 33196452 %R 10.2196/20709 %U http://www.jmir.org/2020/11/e20709/ %U https://doi.org/10.2196/20709 %U http://www.ncbi.nlm.nih.gov/pubmed/33196452 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 7 %N 11 %P e17405 %T A Mobile Health Mindfulness Intervention for Women With Moderate to Moderately Severe Postpartum Depressive Symptoms: Feasibility Study %A Avalos,Lyndsay A %A Aghaee,Sara %A Kurtovich,Elaine %A Quesenberry Jr,Charles %A Nkemere,Linda %A McGinnis,MegAnn K %A Kubo,Ai %+ Kaiser Permanente Northern California, Division of Research, 2000 Broadway, Oakland, CA, 94612, United States, 1 510 891 3426, Lyndsay.A.Avalos@kp.org %K depression %K postpartum %K health services, mental %K eHealth %K mental health %K internet-based intervention %K mindfulness %K behavioral intervention %K mobile phone %D 2020 %7 12.11.2020 %9 Original Paper %J JMIR Ment Health %G English %X Background: Approximately 20% of women suffer from postpartum depression (PPD). Due to barriers such as limited access to care, half of the women with PPD do not receive treatment. Therefore, it is critical to identify effective and scalable interventions. Traditional mindfulness programs have been effective in reducing depressive symptoms, however access remains a barrier. A self-paced mobile health (mHealth) mindfulness program may fit the lifestyle of busy mothers who are unable to attend in-person classes. However, little is known regarding the feasibility or efficacy of mHealth mindfulness interventions in postpartum women with depressive symptoms. Objective: This study aims to assess the feasibility, acceptability, and preliminary efficacy of an mHealth mindfulness intervention for postpartum women with moderate to moderately severe depressive symptoms. Methods: We conducted a single-arm feasibility trial of an mHealth mindfulness intervention within Kaiser Permanente Northern California (KPNC), a large integrated health care system. Participants were identified through clinician referral and electronic health records via KPNC's universal perinatal depression screening program and recruited by the study team. Inclusion criteria included the following: English-speaking, up to 6 months postpartum with a Patient Health Questionnaire (PHQ-8) score of 10 to 19, and no regular mindfulness/meditation practice. Participants were asked to use a mindfulness app, Headspace, 10 to 20 min/day for 6 weeks. Baseline and postintervention surveys captured data on patient-reported outcomes (depression and stress symptoms, sleep quality, and mindfulness). Semistructured interviews captured acceptability. Retention and adherence were used to assess feasibility. Results: Of the 115 women who were contacted and met the eligibility criteria or declined participation before eligibility assessment, 27 (23%) were enrolled. In addition, 70% (19/27) completed the study. The mean age of participants was 31 years (SD 5.2), 30% (8/27) were non-Hispanic White, and, on average, participants were 12.3 weeks postpartum (SD 5.7). Of the women who completed the study, 100% (19/19) used the Headspace app at least once, and nearly half (9/19, 47%) used the app on ≥50% of the days during the 6-week intervention period. Of the 16 participants who completed the postintervention interview, 69% (11/16) reported that they were very or extremely satisfied with the app. Interviews indicated that women appreciated the variety of meditations and felt that the program led to reduced anxiety and improved sleep. Significant improvements in pre- and postintervention scores were observed for depressive symptoms (PHQ-8: −3.8, P=.004), perceived stress (10-item Perceived Stress Scale: −6.0, P=.005), and sleep quality (Pittsburgh Sleep Quality Index: −2.1, P=.02, indicating less sleep disturbance). Improvements in mindfulness were also significant (Five Facet Mindfulness Questionnaire-Short Form: 10.9, P=.01). Conclusions: An mHealth mindfulness intervention for postpartum women with moderate to moderately severe depressive symptoms is feasible and acceptable. An efficacy trial is warranted. %M 33180028 %R 10.2196/17405 %U https://mental.jmir.org/2020/11/e17405 %U https://doi.org/10.2196/17405 %U http://www.ncbi.nlm.nih.gov/pubmed/33180028 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 11 %P e21799 %T Postdischarge Intervention for Stroke Caregivers: Protocol for a Randomized Controlled Trial %A LeLaurin,Jennifer H %A Lamba,Avi H %A Eliazar-Macke,Nathaniel D %A Schmitzberger,Magda K %A Freytes,I Magaly %A Dang,Stuti %A Vogel,W Bruce %A Levy,Charles E %A Klanchar,S Angelina %A Beyth,Rebecca J %A Shorr,Ronald I %A Uphold,Constance R %+ North Florida/South Georgia Veterans Health System, 1601 SW Archer Rd, Gainesville, FL, 32608, United States, 1 352 376 1611, jlelaurin@ufl.edu %K COVID-19 %K stroke %K caregivers %K depression %K burden %K randomized controlled trial %K web-based intervention %K problem-solving %D 2020 %7 11.11.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: The majority of stroke survivors return to their homes and need assistance from family caregivers to perform activities of daily living. These increased demands coupled with the lack of preparedness for their new roles lead to a high risk for caregivers developing depressive symptoms and other negative outcomes. Follow-up home support and problem-solving interventions with caregivers are crucial for maintaining stroke survivors in their homes. Problem-solving interventions are effective but are underused in practice because they require large amounts of staff time to implement and are difficult for caregivers logistically. Objective: The aim of this study is to test a problem-solving intervention for stroke caregivers that can be delivered over the telephone during the patient’s transitional care period (time when the stroke survivor is discharged to home) followed by 8 asynchronous online sessions. Methods: The design is a two-arm parallel randomized clinical trial with repeated measures. We will enroll 240 caregivers from eight Veterans Affairs (VA) medical centers. Participants randomized into the intervention arm receive a modified problem-solving intervention that uses telephone and web-based support and training with interactive modules, fact sheets, and tools on the previously developed and nationally available Resources and Education for Stroke Caregivers’ Understanding and Empowerment Caregiver website. In the usual care group, no changes are made in the information, discharge planning, or care the patients who have had a stroke normally receive, and caregivers have access to existing VA resources (eg, caregiver support line, self-help materials). The primary outcome is a change in caregiver depressive symptoms at 11 and 19 weeks after baseline data collection. Secondary outcomes include changes in stroke caregivers’ burden, knowledge, positive aspects of caregiving, self-efficacy, perceived stress, health-related quality of life, and satisfaction with care and changes in stroke survivors’ functional abilities and health care use. The team will also determine the budgetary impact, facilitators, barriers, and best practices for implementing the intervention. Throughout all phases of the study, we will collaborate with members of an advisory panel. Results: Study enrollment began in June 2015 and is ongoing. The first results are expected to be submitted for publication in 2021. Conclusions: This is the first known study to test a transitional care and messaging center intervention combined with technology to decrease caregiver depressive symptoms and to improve the recovery of stroke survivors. If successful, findings will support an evidence-based model that can be transported into clinical practice to improve the quality of caregiving post stroke. Trial Registration: ClinicalTrials.gov NCT01600131; https://www.clinicaltrials.gov/ct2/show/NCT01600131 International Registered Report Identifier (IRRID): DERR1-10.2196/21799 %M 33174856 %R 10.2196/21799 %U http://www.researchprotocols.org/2020/11/e21799/ %U https://doi.org/10.2196/21799 %U http://www.ncbi.nlm.nih.gov/pubmed/33174856 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 11 %P e20167 %T Assessing the Efficacy and Acceptability of a Web-Based Intervention for Resilience Among College Students: Pilot Randomized Controlled Trial %A Enrique Roig,Angel %A Mooney,Olwyn %A Salamanca-Sanabria,Alicia %A Lee,Chi Tak %A Farrell,Simon %A Richards,Derek %+ E-mental Health Research Group, School of Psychology, Trinity College Dublin, The University of Dublin, College Green, Dublin, , Ireland, 353 1 896 1000, enriquea@tcd.ie %K web-based intervention %K resilience %K well-being %K positive psychology %K human support %K automated support %K college students %K randomized controlled trial %D 2020 %7 11.11.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: College students are at elevated risk for developing mental health problems and face specific barriers around accessing evidence-based treatment. Web-based interventions that focus on mental health promotion and strengthening resilience represent one possible solution. Providing support to users has shown to reduce dropout in these interventions. Further research is needed to assess the efficacy and acceptability of these interventions and explore the viability of automating support. Objective: This study investigated the feasibility of a new web-based resilience program based on positive psychology, provided with human or automated support, in a sample of college students. Methods: A 3-armed closed pilot randomized controlled trial design was used. Participants were randomized to the intervention with human support (n=29), intervention with automated support (n=26), or waiting list (n=28) group. Primary outcomes were resilience and well-being, respectively measured by the Connor–Davidson Resilience Scale and Pemberton Happiness Index. Secondary outcomes included measures of depression and anxiety, self-esteem, and stress. Outcomes were self-assessed through online questionnaires. Intention-to-treat and per-protocol analyses were conducted. Results: All participants demonstrated significant improvements in resilience and related outcomes, including an unexpected improvement in the waiting list group. Within- and between-group effect sizes ranged from small to moderate and within-group effects were typically larger for the human than automated support group. A total of 36 participants began the program and completed 46.46% of it on average. Participants were generally satisfied with the program and found it easy to use. Conclusions: Findings support the feasibility of the intervention. Preliminary evidence for the equal benefit of human and automated support needs to be supported by further research with a larger sample. Results of this study will inform the development of a full-scale trial, from which stronger conclusions may be drawn. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 11866034; http://www.isrctn.com/ISRCTN11866034 International Registered Report Identifier (IRRID): RR2-10.1016/j.invent.2019.100254 %M 33174530 %R 10.2196/20167 %U http://formative.jmir.org/2020/11/e20167/ %U https://doi.org/10.2196/20167 %U http://www.ncbi.nlm.nih.gov/pubmed/33174530 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 3 %N 2 %P e22329 %T eHealth and mHealth Psychosocial Interventions for Youths With Chronic Illnesses: Systematic Review %A Lau,Nancy %A Waldbaum,Shayna %A Parigoris,Ryan %A O'Daffer,Alison %A Walsh,Casey %A Colt,Susannah F %A Yi-Frazier,Joyce P %A Palermo,Tonya M %A McCauley,Elizabeth %A Rosenberg,Abby R %+ Palliative Care and Resilience Lab, Center for Clinical and Translational Research, Seattle Children's Research Institute, 1920 Terry Ave, Seattle, WA, 98101, United States, 1 206 884 0569, nancy.lau@seattlechildrens.org %K pediatrics %K chronic illness %K mHealth %K eHealth %K psychosocial interventions %K mental health %D 2020 %7 10.11.2020 %9 Review %J JMIR Pediatr Parent %G English %X Background: An estimated 12.8% of children and adolescents experience chronic health conditions that lead to poor quality of life, adjustment and coping issues, and concurrent mental health problems. Digital health deployment of psychosocial interventions to support youth with chronic illness has become increasingly popular with the advent of the technological advances in the digital age. Objective: Our objectives were to systematically review published efficacy studies of eHealth and mHealth (mobile health) psychosocial interventions for youths with chronic illnesses and review intervention theory and treatment components. Methods: PubMed, Embase, Web of Science, PsycInfo, and Cochrane Database of Systematic Reviews were searched for studies published from 2008 to 2019 of eHealth and mHealth psychosocial interventions designed for children and adolescents with chronic illnesses in which efficacy outcomes were reported. We excluded studies of interventions for caregivers, healthy youth, disease and medication management, and telehealth interventions that function solely as a platform to connect patients to providers via phone, text, or videoconference. Results: We screened 2551 articles and 133 relevant full-text articles. Sixteen efficacy studies with psychosocial and health outcomes representing 12 unique interventions met the inclusion criteria. Of the included studies, 12 were randomized controlled trials and 4 were prospective cohort studies with no comparison group. Most interventions were based in cognitive behavioral theory and designed as eHealth interventions; only 2 were designed as mHealth interventions. All but 2 interventions provided access to support staff via text, phone, email, or discussion forums. The significant heterogeneity in intervention content, intervention structure, medical diagnoses, and outcomes precluded meta-analysis. For example, measurement time points ranged from immediately postcompletion of the mHealth program to 18 months later, and we identified 39 unique outcomes of interest. The majority of included studies (11/16, 69%) reported significant changes in measured health and/or psychosocial posttreatment outcomes, with small to large effect sizes. Conclusions: Although the available literature on the efficacy of eHealth and mHealth psychosocial interventions for youth with chronic illnesses is limited, preliminary research suggests some evidence of positive treatment responses. Future studies should continue to evaluate whether digital health platforms may be a viable alternative model of delivery to traditional face-to-face approaches. %M 33075743 %R 10.2196/22329 %U http://pediatrics.jmir.org/2020/2/e22329/ %U https://doi.org/10.2196/22329 %U http://www.ncbi.nlm.nih.gov/pubmed/33075743 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 6 %N 2 %P e19362 %T Web-Based Lifestyle Interventions for Prostate Cancer Survivors: Qualitative Study %A Wang,Elizabeth Y %A Graff,Rebecca E %A Chan,June M %A Langlais,Crystal S %A Broering,Jeanette M %A Ramsdill,Justin W %A Kessler,Elizabeth R %A Winters-Stone,Kerri M %A Van Blarigan,Erin L %A Kenfield,Stacey A %+ University of California, San Francisco, 550 16th St, 6th Floor, Box 1695, San Francisco, CA, 94158, United States, 1 5622616634, eyw2107@cumc.columbia.edu %K cancer survivorship %K digital health %K technology-based intervention %K internet-based intervention %K usability %D 2020 %7 10.11.2020 %9 Original Paper %J JMIR Cancer %G English %X Background: Exercise and a healthy diet can improve the quality of life and prognosis of prostate cancer survivors, but there have been limited studies on the feasibility of web-based lifestyle interventions in this population. Objective: This study aims to develop a data-driven grounded theory of web-based engagement by prostate cancer survivors based on their experience in the Community of Wellness, a 12-week randomized clinical trial designed to support healthy diet and exercise habits. Methods: TrueNTH’s Community of Wellness was a four-arm pilot study of men with prostate cancer (N=202) who received progressive levels of behavioral support (level 1: website; level 2: website with individualized diet and exercise recommendations; level 3: website with individualized diet and exercise recommendations, Fitbit, and text messages; and level 4: website with individualized diet and exercise recommendations, Fitbit and text messages, and separate phone calls with an exercise trainer and a registered dietitian). The primary aim of the study is to determine the feasibility and estimate the effects on behaviors (results reported in a separate paper). Following the 12-week intervention, we invited participants to participate in 4 focus groups, one for each intervention level. In this report, we used grounded theory analyses including open, axial, and selective coding to generate codes and themes from the focus group transcripts. Categories were refined across levels using embodied categorization and constant comparative methods. Results: In total, 20 men with prostate cancer participated in the focus groups: 5, 4, 5, and 6 men in levels 1, 2, 3, and 4, respectively. Participants converged on 5 common factors influencing engagement with the intervention: environment (home environment, competing priorities, and other lifestyle programs), motivation (accountability and discordance experienced within the health care system), preparedness (technology literacy, health literacy, trust, and readiness to change), program design (communication, materials, and customization), and program support (education, ally, and community). Each of these factors influenced the survivors’ long-term impressions and habits. We proposed a grounded theory associating these constructs to describe the components contributing to the intuitiveness of a web-based lifestyle intervention. Conclusions: These analyses suggest that web-based lifestyle interventions are more intuitive when we optimize participants’ technology and health literacy; tailor interface design, content, and feedback; and leverage key motivators (ie, health care providers, family members, web-based coach) and environmental factors (ie, familiarity with other lifestyle programs). Together, these grounded theory–based efforts may improve engagement with web-based interventions designed to support prostate cancer survivorship. %M 33170126 %R 10.2196/19362 %U http://cancer.jmir.org/2020/2/e19362/ %U https://doi.org/10.2196/19362 %U http://www.ncbi.nlm.nih.gov/pubmed/33170126 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 11 %P e17494 %T Personalized Web-Based Weight Loss Behavior Change Program With and Without Dietitian Online Coaching for Adults With Overweight and Obesity: Randomized Controlled Trial %A Beleigoli,Alline %A Andrade,Andre Q %A Diniz,Maria De Fatima %A Ribeiro,Antonio Luiz %+ Flinders Digital Health Research Centre, Flinders University, Sturt North (N213), GPO Box 2100, Adelaide, 5001, Australia, 61 8 82013303, alline.beleigoli@flinders.edu.au %K obesity %K overweight %K healthy eating %K diet %K digital health %K web platform %K online coaching %K personalized web interventions %D 2020 %7 5.11.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: The effect of computer- or human-delivered personalized feedback on the effectivess of web-based behavior change platforms for weight loss is unclear. Objective: We aimed to compare the effectiveness of a web-based behavior change intervention personalized through either computerized or human-delivered feedback with a nonpersonalized intervention in promoting weight loss in community-based adults with overweight or obesity. Methods: This pragmatic, 3-group, parallel-arm, randomized trial recruited students and staff in a Brazilian public university who were aged 18 to 60 years, had a BMI of ≥25 kg/m2, and were not pregnant. Participants were allocated to one of 3 groups: platform only (24-week behavior change program delivered using a web platform with personalized computer-delivered feedback), platform plus coaching (same 24-week web-based behavior change program plus 12 weeks of personalized feedback delivered online by a dietitian), or waiting list (nonpersonalized dietary and physical activity recommendations delivered through an e-booklet and videos). Self-reported weight at 24 weeks was the primary outcome. Changes in dietary and physical activity habits within 24 weeks were secondary outcomes. Results: Among the 1298 participants, 375 (28.89%) were lost to follow-up. In the intention-to-treat analysis, the platform-only and platform plus coaching groups had greater mean weight loss than the waiting-list group at 24 weeks (–1.08 kg, 95% CI –1.41 to –0.75 vs –1.57 kg, 95% CI –1.92 to –1.22 vs –0.66 kg, 95% CI –0.98 to –0.34, respectively). The platform-only and platform plus coaching groups, compared with the waiting list group, had a greater increase in the consumption of vegetables (3%, 95% CI 1% to 6% vs 5%, 95% CI 2% to 8% vs –3%, 95% CI –5% to 0%) and fruits (9%, 95% CI 6% to 12% vs 6%, 95% CI 2% to 9% vs 2%, 95% CI 0% to 6%) and a larger reduction in ultraprocessed food intake (–18%, 95% CI –23% to –13% vs –25%, 95% CI –30% to –20% vs –12%, 95% CI –16% to –8%). Changes in physical activity did not differ across the groups. Engagement was higher in the platform plus coaching group than in the platform-only group (7.6 vs 5.2 completed sessions; P=.007). Longer usage of the platform was associated with clinically meaningful (≥5%) weight loss (odds ratio 1.02, 95% CI 1.01 to 1.04). Conclusions: The web-based behavior change programs with computer- and human-delivered personalized feedback led to greater, albeit small-magnitude, weight loss within 24 weeks. Improvement in multiple dietary habits, but not physical activity, were also greater in the personalized programs compared with the nonpersonalized one. The human-delivered personalized feedback by the online dietitian coach increased user engagement with the program and was associated with a significantly higher chance of clinically meaningful weight loss. Trial Registration: ClinicalTrials.gov NCT03435445; https://clinicaltrials.gov/ct2/show/NCT03435445 International Registered Report Identifier (IRRID): RR2-10.2196/10.1186/s12889-018-5882-y %M 33151151 %R 10.2196/17494 %U https://www.jmir.org/2020/11/e17494 %U https://doi.org/10.2196/17494 %U http://www.ncbi.nlm.nih.gov/pubmed/33151151 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 11 %P e22878 %T Mobile App Strategy to Facilitate Human Papillomavirus Vaccination Among Young Men Who Have Sex With Men: Pilot Intervention Study %A Fontenot,Holly B %A White,Bradley Patrick %A Rosenberger,Joshua G %A Lacasse,Hailee %A Rutirasiri,Chokdee %A Mayer,Kenneth H %A Zimet,Gregory %+ School of Nursing and Dental Hygiene, University of Hawaii at Manoa, 2528 McCarthy Mall, Webster Hall 412, Honolulu, HI, 96822, United States, 1 808 956 4917, hbfont@hawaii.edu %K human papillomavirus %K men who have sex with men %K vaccination %K mobile health tool %K mHealth %D 2020 %7 4.11.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Mobile app-based interventions have been identified as potential facilitators for vaccination among young men who have sex with men (MSM). Objective: This pilot study aimed to test the feasibility of a theoretically informed mobile health (mHealth) tool designed to reduce health disparities and facilitate human papillomavirus (HPV) vaccination among a sample of young MSM. Methods: The development of the mHealth tool was guided by previous research, implementation intention theory, and design thinking. We recruited MSM aged 18-26 years through a popular online dating app and linked participants to our mHealth tool, which provided HPV vaccine information and fostered access to care. Results: A total of 42 young MSM participated in this pilot study in Boston, Massachusetts. Participants reported variable HPV knowledge (ie, high knowledge of HPV risk factors and low knowledge of HPV-related cancer risks for men) and positive vaccine beliefs and attitudes. Of those who were either unvaccinated, not up to date, or did not report vaccine status, 23% (8/35) utilized the mHealth tool to obtain HPV vaccination. Participants primarily utilized the tool’s (1) educational components and (2) capabilities facilitating concrete vaccine action plans. Conclusions: We recruited an underserved at-risk population of youth via an online dating app for our mHealth intervention that resulted in in-person health care delivery. This study was limited by enrollment challenges, including low willingness to download the mHealth tool to mobile devices. %M 33146621 %R 10.2196/22878 %U https://www.jmir.org/2020/11/e22878 %U https://doi.org/10.2196/22878 %U http://www.ncbi.nlm.nih.gov/pubmed/33146621 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e20113 %T A Web Application About Herd Immunity Using Personalized Avatars: Development Study %A Hakim,Hina %A Bettinger,Julie A %A Chambers,Christine T %A Driedger,S Michelle %A Dubé,Eve %A Gavaruzzi,Teresa %A Giguere,Anik M C %A Kavanagh,Éric %A Leask,Julie %A MacDonald,Shannon E %A Orji,Rita %A Parent,Elizabeth %A Paquette,Jean-Sébastien %A Roberge,Jacynthe %A Sander,Beate %A Scherer,Aaron M %A Tremblay-Breault,Martin %A Wilson,Kumanan %A Reinharz,Daniel %A Witteman,Holly O %+ Department of Family and Emergency Medicine, Laval University, 1050 avenue de la Médecine, Pavillon Ferdinand-Vandry 2881, Université Laval, Quebec City, QC, G1V 0A6, Canada, 1 418 656 2131 ext 3981, holly.witteman@fmed.ulaval.ca %K community immunity %K herd immunity %K vaccination %K vaccine hesitancy %K avatar %K web application %D 2020 %7 30.10.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Herd immunity or community immunity refers to the reduced risk of infection among susceptible individuals in a population through the presence and proximity of immune individuals. Recent studies suggest that improving the understanding of community immunity may increase intentions to get vaccinated. Objective: This study aims to design a web application about community immunity and optimize it based on users’ cognitive and emotional responses. Methods: Our multidisciplinary team developed a web application about community immunity to communicate epidemiological evidence in a personalized way. In our application, people build their own community by creating an avatar representing themselves and 8 other avatars representing people around them, for example, their family or coworkers. The application integrates these avatars in a 2-min visualization showing how different parameters (eg, vaccine coverage, and contact within communities) influence community immunity. We predefined communication goals, created prototype visualizations, and tested four iterative versions of our visualization in a university-based human-computer interaction laboratory and community-based settings (a cafeteria, two shopping malls, and a public library). Data included psychophysiological measures (eye tracking, galvanic skin response, facial emotion recognition, and electroencephalogram) to assess participants’ cognitive and affective responses to the visualization and verbal feedback to assess their interpretations of the visualization’s content and messaging. Results: Among 110 participants across all four cycles, 68 (61.8%) were women and 38 (34.5%) were men (4/110, 3.6%; not reported), with a mean age of 38 (SD 17) years. More than half (65/110, 59.0%) of participants reported having a university-level education. Iterative changes across the cycles included adding the ability for users to create their own avatars, specific signals about who was represented by the different avatars, using color and movement to indicate protection or lack of protection from infectious disease, and changes to terminology to ensure clarity for people with varying educational backgrounds. Overall, we observed 3 generalizable findings. First, visualization does indeed appear to be a promising medium for conveying what community immunity is and how it works. Second, by involving multiple users in an iterative design process, it is possible to create a short and simple visualization that clearly conveys a complex topic. Finally, evaluating users’ emotional responses during the design process, in addition to their cognitive responses, offers insights that help inform the final design of an intervention. Conclusions: Visualization with personalized avatars may help people understand their individual roles in population health. Our app showed promise as a method of communicating the relationship between individual behavior and community health. The next steps will include assessing the effects of the application on risk perception, knowledge, and vaccination intentions in a randomized controlled trial. This study offers a potential road map for designing health communication materials for complex topics such as community immunity. %M 33124994 %R 10.2196/20113 %U https://www.jmir.org/2020/10/e20113 %U https://doi.org/10.2196/20113 %U http://www.ncbi.nlm.nih.gov/pubmed/33124994 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e20790 %T Effects of a Mobile and Web App (Thought Spot) on Mental Health Help-Seeking Among College and University Students: Randomized Controlled Trial %A Wiljer,David %A Shi,Jenny %A Lo,Brian %A Sanches,Marcos %A Hollenberg,Elisa %A Johnson,Andrew %A Abi-Jaoudé,Alexxa %A Chaim,Gloria %A Cleverley,Kristin %A Henderson,Joanna %A Isaranuwatchai,Wanrudee %A Levinson,Andrea %A Robb,Janine %A Wong,Howard W %A Voineskos,Aristotle %+ UHN Digital, University Health Network, 190 Elizabeth Street, R. Fraser Elliott Building RFE 3-411, Toronto, ON, Canada, 1 416 340 4800 ext 6322, david.wiljer@uhn.ca %K crowdsourcing %K help-seeking behavior %K mental health %K mobile applications %K randomized controlled trial %K school mental health services %K social support %K young adult %D 2020 %7 30.10.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Mental health disorders are the most prevalent health issues among postsecondary students, yet few solutions to this emerging crisis exist. While mobile health technologies are touted as promising solutions for the unmet mental health needs of these students, the efficacy of these tools remains unclear. In response to these gaps, this study evaluates Thought Spot, a mobile and web app created through participatory design research. Objective: The goal of the research is to examine the impact of Thought Spot on mental health and wellness help-seeking intentions, behaviors, attitudes, self-stigma, and self-efficacy among postsecondary students in Canada. Methods: A 2-armed randomized controlled trial involving students from three postsecondary institutions was conducted. Students were eligible if they were aged 17 to 29 years, enrolled in full-time or part-time studies, functionally competent in English, and had access to a compatible digital device. The usual care group received a mental health services information pamphlet. The intervention group received the Thought Spot app on their digital device. Thought Spot is a standalone app that allows users to add, review, and search crowdsourced information about nearby mental health and wellness services. Users can also track their mood on the app. Outcomes were self-assessed through questionnaires collected at baseline and 3 and 6 months. The primary outcome was change in formal help-seeking intentions from baseline to 6 months, measured by the General Help-Seeking Questionnaire. A mixed-effects model was used to compare the impact of usual care and intervention on the primary outcome (formal help-seeking intentions). Secondary outcomes included changes in informal help-seeking intentions and help-seeking behaviors, help-seeking attitudes, self-stigma, and self-efficacy. Results: A total of 481 students were randomized into two groups: 240 to usual care, and 241 to the intervention group. There were no significant differences in help-seeking intentions between the usual care and intervention groups over 6 months (F2,877=0.85; P=.43, f=0.04). Both groups demonstrated similar increases in formal help-seeking intentions at 3 and 6 months (F2,877=23.52; P<.001, f=0.21). Compared with males, females sought more help from formal resources (OR 1.86; 95% CI 1.22 to 2.83, P=.001). Females were less likely to seek help from informal sources than males (OR 0.80; 95% CI 0.22 to 0.73, P<.001). Conclusions: Prompting postsecondary students about mental health and help-seeking appears to increase help-seeking intentions. mHealth interventions may be as effective as information pamphlets in increasing formal help-seeking but may confer a small advantage in driving help-seeking from informal sources. Although there is enthusiasm, developers and health policy experts should exercise caution and thoroughly evaluate these types of digital tools. Future studies should explore the cost-effectiveness of digital interventions and develop strategies for improving their efficacy. Trial Registration: ClinicalTrials.gov NCT03412461; https://clinicaltrials.gov/ct2/show/NCT03412461 International Registered Report Identifier (IRRID): RR2-10.2196/resprot.6446 %M 33124984 %R 10.2196/20790 %U http://www.jmir.org/2020/10/e20790/ %U https://doi.org/10.2196/20790 %U http://www.ncbi.nlm.nih.gov/pubmed/33124984 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e16378 %T Effectiveness of a Peer-Led Web-Based Intervention to Improve General Self-Efficacy in Using Dating Apps Among Young Adults: Randomized Clustered Trial %A Wong,William CW %A Sun,Wai Han %A Chia,Shu Ming Cheryl %A Tucker,Joseph D %A Mak,William PH %A Song,Lin %A Choi,Kitty Wai Ying %A Lau,Stephanie Tsz Hei %A Wan,Eric Yuk Fai %+ Department of Family Medicine and Primary Care, University of Hong Kong, 3/F, Ap Lei Chau Clinic, 161 Main Street, Ap Lei Chau,, Hong Kong, China, 852 64883866, wongwcw@hku.hk %K internet %K sexual health %K self-efficacy %K young adult %K risk assessment %D 2020 %7 30.10.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Online dating apps are popular platforms for seeking romance and sexual relationships among young adults. As mobile apps can easily gain access to a pool of strangers (“new friends”) at any time and place, it leads to heightened sexual health risks and privacy concerns. Objective: This study aimed to evaluate the effectiveness of a peer-led web-based intervention for online dating apps to prepare Chinese college students so that they have better self-efficacy when using dating apps. Methods: An open clustered randomized controlled trial was conducted among students from three colleges (The University of Hong Kong, Hang Seng University of Hong Kong, and Yijin Programme of Vocational Training College) in Hong Kong. Students aged 17 to 27 years who attended common core curriculum or general education were randomized into intervention and control groups. The intervention material, developed with high peer engagement, included four short videos, an interactive scenario game, and a risk assessment tool. An existing website promoting physical activities and healthy living was used as a control. Using the information, motivation, and behavioral skills (IMB) approach to design the evaluation, questionnaires covering participants’ sociodemographics and dating app characteristics, as well as the general self-efficacy scale (GSE) as the primary outcome and the risk propensity scale (RPS) as the secondary outcome were administered before, immediately after, and at 1 month after the intervention. Intention-to-treat analysis was adopted, and between-group differences were assessed using the Mann-Whitney U test. A post-hoc multiple linear regression model was used to examine the correlates of the GSE and RPS. Results: A total of 578 eligible participants (290 in the intervention group and 288 in the control group) participated in the study with 36 lost to follow-up. There were more female participants (318/542, 58.7%) than male participants in the sample, reflecting the distribution of college students. Over half of the participants (286/542, 52.8%) reported the following reasons for using dating apps: being curious (170/498, 34.1%), trying to make new friends (158/498, 31.7%), and finding friends with similar interests (121/498, 24.3%). Overall, the participants in the intervention group reported favorable experiences when compared with the finding in the control group. There was significant improvement in the GSE score and reduction in the RPS score (P<.001) in the intervention group. University of Hong Kong students were more susceptible to risk reduction after the intervention when compared with students from the other two institutions. Conclusions: The online intervention was effective in improving general self-efficacy and reducing risk tendency among young students. Future work is needed to determine if this approach is cost-effective and such behavioral change is sustainable. Trial Registration: ClinicalTrials.gov NCT03685643; https://clinicaltrials.gov/ct2/show/NCT03685643. International Registered Report Identifier (IRRID): RR2-10.1186/s13063-018-3167-5 %M 33124987 %R 10.2196/16378 %U http://www.jmir.org/2020/10/e16378/ %U https://doi.org/10.2196/16378 %U http://www.ncbi.nlm.nih.gov/pubmed/33124987 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e20631 %T Digital Micro Interventions for Behavioral and Mental Health Gains: Core Components and Conceptualization of Digital Micro Intervention Care %A Baumel,Amit %A Fleming,Theresa %A Schueller,Stephen M %+ University of Haifa, Abba Khoushy Ave 199, Haifa, 3498838, Israel, 972 48240111, abaumel@univ.haifa.ac.il %K micro intervention %K mental health %K mhealth %K eHealth %K engagement %K intervention %K adherence %K behavior change %K behavioral health %D 2020 %7 29.10.2020 %9 Viewpoint %J J Med Internet Res %G English %X Although many people access publicly available digital behavioral and mental health interventions, most do not invest as much effort in these interventions as hoped or intended by intervention developers, and ongoing engagement is often low. Thus, the impact of such interventions is minimized by a misalignment between intervention design and user behavior. Digital micro interventions are highly focused interventions delivered in the context of a person’s daily life with little burden on the individual. We propose that these interventions have the potential to disruptively expand the reach of beneficial therapeutics by lowering the bar for entry to an intervention and the effort needed for purposeful engagement. This paper provides a conceptualization of digital micro interventions, their component parts, and principles guiding their use as building blocks of a larger therapeutic process (ie, digital micro intervention care). The model represented provides a structure that could improve the design, delivery, and research on digital micro interventions and ultimately improve behavioral and mental health care and care delivery. %M 33118946 %R 10.2196/20631 %U http://www.jmir.org/2020/10/e20631/ %U https://doi.org/10.2196/20631 %U http://www.ncbi.nlm.nih.gov/pubmed/33118946 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e19685 %T Web-Based Patient-Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care): Multicenter Pragmatic Nonrandomized Trial %A Girgis,Afaf %A Durcinoska,Ivana %A Arnold,Anthony %A Descallar,Joseph %A Kaadan,Nasreen %A Koh,Eng-Siew %A Miller,Andrew %A Ng,Weng %A Carolan,Martin %A Della-Fiorentina,Stephen A %A Avery,Sandra %A Delaney,Geoff P %+ Centre for Oncology Education and Research Translation, Ingham Institute for Applied Medical Research, 1 Campbell St, Liverpool, Sydney, 2170, Australia, 61 0412142841, afaf.girgis@unsw.edu.au %K patient-reported outcomes (PROs) %K eHealth %K patient-centered care %K electronic health record %K nonrandomized controlled trial %K emergency department presentations %K pragmatic trial %K symptom screening %D 2020 %7 29.10.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite the acceptability and efficacy of e–patient-reported outcome (ePRO) systems, implementation in routine clinical care remains challenging. Objective: This pragmatic trial implemented the PROMPT-Care (Patient Reported Outcome Measures for Personalized Treatment and Care) web-based system into existing clinical workflows and evaluated its effectiveness among a diverse population of patients with cancer. Methods: Adult patients with solid tumors receiving active treatment or follow-up care in four cancer centers were enrolled. The PROMPT-Care intervention supported patient management through (1) monthly off-site electronic PRO physical symptom and psychosocial well-being assessments, (2) automated electronic clinical alerts notifying the care team of unresolved clinical issues following two consecutive assessments, and (3) tailored online patient self-management resources. Propensity score matching was used to match controls with intervention patients in a 4:1 ratio for patient age, sex, and treatment status. The primary outcome was a reduction in emergency department presentations. Secondary outcomes were time spent on chemotherapy and the number of allied health service referrals. Results: From April 2016 to October 2018, 328 patients from four public hospitals received the intervention. Matched controls (n=1312) comprised the general population of patients with cancer, seen at the participating hospitals during the study period. Emergency department visits were significantly reduced by 33% (P=.02) among patients receiving the intervention compared with patients in the matched controls. No significant associations were found in allied health referrals or time to end of chemotherapy. At baseline, the most common patient reported outcomes (above-threshold) were fatigue (39%), tiredness (38.4%), worry (32.9%), general wellbeing (32.9%), and sleep (24.1%), aligning with the most frequently accessed self-management domain pages of physical well-being (36%) and emotional well-being (23%). The majority of clinical feedback reports were reviewed by nursing staff (729/893, 82%), largely in response to the automated clinical alerts (n=877). Conclusions: Algorithm-supported web-based systems utilizing patient reported outcomes in clinical practice reduced emergency department presentations among a diverse population of patients with cancer. This study also highlighted the importance of (1) automated triggers for reviewing above-threshold results in patient reports, rather than passive manual review of patient records; (2) the instrumental role nurses play in managing alerts; and (3) providing patients with resources to support guided self-management, where appropriate. Together, these factors will inform the integration of web-based PRO systems into future models of routine cancer care. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12616000615482; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370633 International Registered Report Identifier (IRRID): RR2-10.1186/s12885-018-4729-3 %M 33118954 %R 10.2196/19685 %U http://www.jmir.org/2020/10/e19685/ %U https://doi.org/10.2196/19685 %U http://www.ncbi.nlm.nih.gov/pubmed/33118954 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e16774 %T Toward a Digital Platform for the Self-Management of Noncommunicable Disease: Systematic Review of Platform-Like Interventions %A Tighe,Sarah A %A Ball,Kylie %A Kensing,Finn %A Kayser,Lars %A Rawstorn,Jonathan C %A Maddison,Ralph %+ Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, VIC 3125, Australia, 61 92468383 ext 95590, stighe@deakin.edu.au %K noncommunicable diseases %K chronic disease %K web-based intervention %K mobile health %K self-management %K health behavior %K mobile phone %D 2020 %7 28.10.2020 %9 Review %J J Med Internet Res %G English %X Background: Digital interventions are effective for health behavior change, as they enable the self-management of chronic, noncommunicable diseases (NCDs). However, they often fail to facilitate the specific or current needs and preferences of the individual. A proposed alternative is a digital platform that hosts a suite of discrete, already existing digital health interventions. A platform architecture would allow users to explore a range of evidence-based solutions over time to optimize their self-management and health behavior change. Objective: This review aims to identify digital platform-like interventions and examine their potential for supporting self-management of NCDs and health behavior change. Methods: A literature search was conducted in January 2020 using EBSCOhost, PubMed, Scopus, and EMBASE. No digital platforms were identified, so criteria were broadened to include digital platform-like interventions. Eligible platform-like interventions offered a suite of discrete, evidence-based health behavior change features to optimize self-management of NCDs in an adult population and provided digitally supported guidance for the user toward the features best suited to their needs and preferences. Data collected on interventions were guided by the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online Telehealth) checklist, including evaluation data on effectiveness and process outcomes. The quality of the included literature was assessed using the Mixed Methods Appraisal Tool. Results: A total of 7 studies were included for review. Targeted NCDs included cardiovascular diseases (CVD; n=3), diabetes (n=3), and chronic obstructive pulmonary disease (n=1). The mean adherence (based on the number of follow-up responders) was 69% (SD 20%). Of the 7 studies, 4 with the highest adherence rates (80%) were also guided by behavior change theories and took an iterative, user-centered approach to development, optimizing intervention relevance. All 7 interventions presented algorithm-supported user guidance tools, including electronic decision support, smart features that interact with patterns of use, and behavior change stage-matching tools. Of the 7 studies, 6 assessed changes in behavior. Significant effects in moderate-to-vigorous physical activity were reported, but for no other specific health behaviors. However, positive behavior change was observed in studies that focused on comprehensive behavior change measures, such as self-care and self-management, each of which addresses several key lifestyle risk factors (eg, medication adherence). No significant difference was found for psychosocial outcomes (eg, quality of life). Significant changes in clinical outcomes were predominately related to disease-specific, multifaceted measures such as clinical disease control and cardiovascular risk score. Conclusions: Iterative, user-centered development of digital platform structures could optimize user engagement with self-management support through existing, evidence-based digital interventions. Offering a palette of interventions with an appropriate degree of guidance has the potential to facilitate disease-specific health behavior change and effective self-management among a myriad of users, conditions, or stages of care. %M 33112239 %R 10.2196/16774 %U http://www.jmir.org/2020/10/e16774/ %U https://doi.org/10.2196/16774 %U http://www.ncbi.nlm.nih.gov/pubmed/33112239 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e16802 %T 24-Month Outcomes of Primary Care Web-Based Depression Prevention Intervention in Adolescents: Randomized Clinical Trial %A Van Voorhees,Benjamin %A Gladstone,Tracy R G %A Sobowale,Kunmi %A Brown,C Hendricks %A Aaby,David A %A Terrizzi,Daniela A %A Canel,Jason %A Ching,Eumene %A Berry,Anita D %A Cantorna,James %A Eder,Milton %A Beardslee,William %A Fitzgibbon,Marian %A Marko-Holguin,Monika %A Schiffer,Linda %A Lee,Miae %A de Forest,Sarah A %A Sykes,Emily E %A Suor,Jennifer H %A Crawford,Theodore J %A Burkhouse,Katie L %A Goodwin,Brady C %A Bell,Carl %+ Department of General Pediatrics, University of Illinois at Chicago, College of Medicine, 840 South Wood Street (MC 856), Chicago, IL, United States, 1 312 996 8352, bvanvoor@uic.edu %K adolescent %K depression %K prevention %K scalable %K eHealth %D 2020 %7 28.10.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Adolescent depression carries a high burden of disease worldwide, but access to care for this population is limited. Prevention is one solution to curtail the negative consequences of adolescent depression. Internet interventions to prevent adolescent depression can overcome barriers to access, but few studies examine long-term outcomes. Objective: This study compares CATCH-IT (Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training), an internet-based intervention, to a general health education active control for depression onset at 12 and 24 months in adolescents presenting to primary care settings. Methods: A 2-site randomized trial, blinded to the principal investigators and assessors, was conducted comparing Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training to health education to prevent depressive episodes in 369 adolescents (193 youths were randomly assigned to Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training and 176 to health education) with subthreshold depressive symptoms or prior depressive episodes. Participants were recruited from primary care settings in the United States. The primary outcome was the occurrence of a depressive episode, determined by the Depression Symptom Rating. The secondary outcome was functioning, measured by the Global Assessment Scale. Results: In intention-to-treat analyses, the adjusted hazard ratio favoring Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training for first depressive episode was not statistically significant at 12 months (hazard ratio 0.77, 95% CI 0.42-1.40, P=.39) and 24 months (hazard ratio 0.87, 95% CI 0.52-1.47, P=.61). Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training provided preventive benefit for first depressive episode for those with mild hopelessness or at least moderate paternal monitoring at baseline. Global Assessment Scale scores improved comparably in both groups (intention-to-treat). Conclusions: A technology-based intervention for adolescent depression prevention implemented in primary care did not have additional benefit at 12 or 24 months. Further research is necessary to determine whether internet interventions have long-term benefit. Trial Registration: ClinicalTrials.gov NCT01893749; http://clinicaltrials.gov/ct2/show/NCT01893749. %M 33112254 %R 10.2196/16802 %U https://www.jmir.org/2020/10/e16802 %U https://doi.org/10.2196/16802 %U http://www.ncbi.nlm.nih.gov/pubmed/33112254 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 10 %P e17898 %T Follow-Up of Cancer Patients Receiving Anti-PD-(L)1 Therapy Using an Electronic Patient-Reported Outcomes Tool (KISS): Prospective Feasibility Cohort Study %A Iivanainen,Sanna %A Alanko,Tuomo %A Vihinen,Pia %A Konkola,Teemu %A Ekstrom,Jussi %A Virtanen,Henri %A Koivunen,Jussi %+ Department of Oncology and Radiotherapy, Oulu University Hospital, PB 22, 90029 OYS, Oulu, Finland, 358 83153789, jussi.koivunen@ppshp.fi %K ePRO %K immune checkpoint inhibitors %K symptoms %K side-effects %K anti-PD-(L)1 therapy %D 2020 %7 28.10.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: Immune checkpoint inhibitors (ICIs) have become a standard of care for various tumor types. Their unique spectrum of side effects demands continuous and long-lasting assessment of symptoms. Electronic patient-reported outcome (ePRO) follow-up has been shown to improve survival and quality of life of cancer patients treated with chemotherapy. Objective: This study aimed to investigate whether ePRO follow-up of cancer patients treated with ICIs is feasible. The study analyzed (1) the variety of patient reported symptoms, (2) etiology of alerts, (3) symptom correlations, and (4) patient compliance. Methods: In this prospective, one-arm, multi-institutional study, we recruited adult cancer patients whose advanced cancer was treated with anti-programmed cell death protein 1 (PD)- ligand (L)1 agents in outpatient settings. The ePRO tool consisted of a weekly questionnaire evaluating the presence of typical side effects, with an algorithm assessing the severity of the symptom according to National Cancer Institute Common Terminology Criteria for Adverse Events and an urgency algorithm sending alerts to the care team. A patient experience survey was conducted monthly. The patients were followed up to 6 months or until disease progression. Results: A total of 889 symptom questionnaires was completed by 37 patients (lung cancer, n=15; melanoma, n=9; genitourinary cancer, n=9; head and neck cancer, n=4). Patients showed good adherence to ePRO follow-up. The most common grade 1 symptoms were fatigue (28%) and itching (13%), grade 2 symptoms were loss of appetite (12%) and nausea (12%), and grade 3-4 symptoms were cough (6%) and loss of appetite (4%). The most common reasons for alerts were loss of appetite and shortness of breath. In the treatment benefit analysis, positive correlations were seen between clinical benefit and itching as well as progressive disease and chest pain. Conclusions: According to the results, ePRO follow-up of cancer patients receiving ICIs is feasible. ePROs capture a wide range of symptoms. Some symptoms correlate to treatment benefit, suggesting that individual prediction models could be generated. Trial Registration: Clinical Trials Register, NCT3928938; https://clinicaltrials.gov/ct2/show/NCT03928938 %M 33112242 %R 10.2196/17898 %U http://formative.jmir.org/2020/10/e17898/ %U https://doi.org/10.2196/17898 %U http://www.ncbi.nlm.nih.gov/pubmed/33112242 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e22324 %T Efficacy of Electronic Acupuncture Shoes for Chronic Low Back Pain: Double-Blinded Randomized Controlled Trial %A Yeh,Bo-Yan %A Liu,Geng-Hao %A Lee,Tzung-Yan %A Wong,Alice May-Kuen %A Chang,Hen-Hong %A Chen,Yu-Sheng %+ Division of Acupuncture and Moxibustion, Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Linkou, No.123, Dinghu Rd., Guishan Township, Taoyuan, 33378, Taiwan, 886 33196200 ext 2613, cusp01@cgmh.org.tw %K acupuncture %K electronic acupuncture shoes %K low back pain %K medical device %K self-treatment %K mHealth %D 2020 %7 26.10.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic low back pain is a common problem and is associated with high costs, including those related to health care and indirect costs due to absence at work or reduced productivity. Previous studies have demonstrated that acupuncture or electroacupuncture can relieve low back pain. Electronic acupuncture shoes (EAS) are a novel device designed in this study. This device combines the properties of acupuncture and transcutaneous electrical nerve stimulation for clinical use. Objective: The aim of this study was to evaluate the efficacy of EAS in patients with chronic low back pain. Methods: In this prospective double-blinded randomized controlled study, the data of 83 patients who experienced chronic low back pain were analyzed. Patients came to our clinic for 20 visits and underwent assessment and treatment. Patients were randomly allocated to receive either EAS plus placebo nonsteroidal anti-inflammatory drugs (NSAIDs) (EAS group, n=42) or sham EAS plus NSAIDs (NSAID group, n=41). The visual analog scale (VAS) score and range of motion were assessed at baseline, before and after each EAS treatment, and 2 weeks after the last treatment. The time for achieving pain remission was recorded. Quality of life was assessed at the 2nd, 14th, and 20th visits. Results: After 6 weeks of treatment, the treatment success rate in each visit in the EAS group was higher than that in the NSAID group, as revealed by the intention-to-treat (ITT) and per-protocol (PP) analyses, but significant differences were observed only during the 16th visit in the ITT analysis (EAS group: 31/37, 84% and NSAID group: 21/34, 62%; P=.04). The change in the VAS score from baseline in each visit in the EAS group was greater than that in the NSAID group, as revealed by the ITT and PP analyses, and significant differences were observed in the 5th visit and 9th visit in the ITT analysis (P=.048 and P=.048, respectively). Significant differences were observed in the left rotation in the 2nd visit and 4th visit (P=.049 and P=.03, respectively). No significant differences were observed in the VAS score before and after treatment in each visit and in the quality of life in both groups. Conclusions: EAS might serve as a reliable alternative therapeutic tool for patients with chronic low back pain who are contraindicated for oral NSAIDs. Trial Registration: ClinicalTrials.gov NCT02468297 https://clinicaltrials.gov/ct2/show/NCT02468297 %M 33104004 %R 10.2196/22324 %U http://www.jmir.org/2020/10/e22324/ %U https://doi.org/10.2196/22324 %U http://www.ncbi.nlm.nih.gov/pubmed/33104004 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 10 %P e17522 %T Mobile Social Network–Based Smoking Cessation Intervention for Chinese Male Smokers: Pilot Randomized Controlled Trial %A Chen,Jinsong %A Ho,Elsie %A Jiang,Yannan %A Whittaker,Robyn %A Yang,Tingzhong %A Bullen,Christopher %+ National Institute for Health Innovation, School of Population Health, University of Auckland, 22-30 Park Ave, Grafton, Auckland, 1023, New Zealand, 64 0220951065, jinsong.chen@auckland.ac.nz %K mHealth %K mobile smoking cessation %K social network-based intervention %K smoking cessation %K public health %K gamified health interventions %D 2020 %7 23.10.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Around 2 million Chinese people, mostly men, die annually from tobacco-related diseases; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation support. Objective: This study aimed to test the preliminary effectiveness and feasibility for a mobile social network (WeChat)–based smoking cessation intervention (SCAMPI program) among Chinese male smokers. Methods: Chinese male smokers aged 25-44 years were recruited online from WeChat, the most widely used social media platform in China. Individuals using other smoking cessation interventions or who lacked capacity to provide online informed consent were excluded. Participants were randomly assigned (1:1) to intervention or control groups. Neither participants nor researchers were masked to assignment. The trial was fully online. All data were collected via WeChat. The intervention group received access to the full-version SCAMPI program, a Chinese-language smoking cessation program based on the Behaviour Change Wheel framework and relevant cessation guidelines. Specific intervention functions used in the program include: planning to help users make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, information about smoking harms, motivational messages to help users overcome urges, standardized tests for users to assess their levels of nicotine dependence and lung health, as well as a social platform to encourage social support between users. The control group had access to a static WeChat page of contacts for standard smoking cessation care. Both groups received incentive credit payments for participating. The primary outcome was 30-day biochemically verified smoking abstinence at 6 weeks after randomization, with missing data treated as not quitting. Secondary outcomes were other smoking status measures, reduction of cigarette consumption, study feasibility (recruitment and retention rate), and acceptability of and satisfaction with the program. Results: The program recorded 5736 visitors over a 13-day recruitment period. We recruited 80 participants who were randomly allocated to two arms (n=40 per arm). At 6 weeks, 36 of 40 (90%) intervention participants and 35 of 40 (88%) control participants provided complete self-reported data on their daily smoking status via WeChat. Biochemically verified smoking abstinence at 6 weeks was determined for 10 of 40 (25%) intervention participants and 2 of 40 (5%) control participants (RR=5, 95% CI 1.2-21.4, P=.03). In the intervention group, the calculator function, motivational messages, and health tests were underused (less than once per week per users). Participants rated their satisfaction with the intervention program as 4.56 out of 5.00. Conclusions: Our program is a novel, accessible, and acceptable smoking cessation intervention for Chinese male smokers. A future trial with a greater sample size and longer follow-up will identify if it is as effective as these preliminary data suggest. Trial Registration: ANZCTR registry, ACTRN12618001089224; https://tinyurl.com/y536n7sx International Registered Report Identifier (IRRID): RR2-18071 %M 33095184 %R 10.2196/17522 %U http://mhealth.jmir.org/2020/10/e17522/ %U https://doi.org/10.2196/17522 %U http://www.ncbi.nlm.nih.gov/pubmed/33095184 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e23868 %T Health-Related Quality of Life Improvements in Systemic Lupus Erythematosus Derived from a Digital Therapeutic Plus Tele-Health Coaching Intervention: Randomized Controlled Pilot Trial %A Khan,Faiz %A Granville,Nora %A Malkani,Raja %A Chathampally,Yash %+ EVP, CityMD, 101 Long Drive Court, Dix Hills, NY, 11746, United States, 1 516 426 9086, fkhan@citymd.net %K systemic lupus erythematosus %K digital health %K digital therapeutic %K autoimmunity %K food as medicine %K dietary intervention %K health-related quality of life %K lifestyle medicine %K mobile health %K environmental influences on autoimmunity %D 2020 %7 20.10.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Systemic lupus erythematosus (SLE), a systemic autoimmune disease with no known cure, remains poorly understood and patients suffer from many gaps in care. Recent work has suggested that dietary and other lifestyle factors play an important role in triggering and propagating SLE in some susceptible individuals. However, the magnitude of influence of these triggers, how to identify pertinent triggers in individual patients, and whether removing these triggers confers clinical benefit is unknown. Objective: To demonstrate that a digital therapeutic intervention, utilizing a mobile app that allows self-tracking of dietary, environmental, and lifestyle triggers, paired with telehealth coaching, added to usual care, improves quality of life in patients with SLE compared with usual care alone. Methods: In this randomized controlled pilot study, adults with SLE were assigned to a 16-week digital therapeutic intervention plus usual care or usual care alone. Primary outcome measures were changes from baseline to 16 weeks on 3 validated health-related quality of life (HRQoL) tools: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Brief Pain Inventory-Short Form (BPI-SF), and Lupus Quality of Life (LupusQoL). Results: A total of 50 patients were randomized (23 control, 27 intervention). In per-protocol analysis, the intervention group achieved significantly greater improvement than the control group in 9 of 11 domains: FACIT-F (34% absolute improvement for the intervention group vs –1% for the control group, P<.001), BPI-SF-Pain Interference (25% vs 0%, P=.02), LupusQoL-Planning (17% vs 0%, P=.004), LupusQoL-Pain (13% vs 0%, P=.004), LupusQoL-Emotional Health (21% vs 4%, P=.02), and LupusQoL-Fatigue (38% vs 13%, P<.001) were significant when controlling for multiple comparisons; BPI-SF-Pain Severity (13% vs –6%, P=.049), LupusQoL-Physical Health (17% vs 3%, P=.049), and LupusQoL-Burden to Others (33% vs 4%, P=.04) were significant at an unadjusted 5% significance level. Conclusions: A digital therapeutic intervention that pairs self-tracking with telehealth coaching to identify and remove dietary, environmental, and lifestyle symptom triggers resulted in statistically significant, clinically meaningful improvements in HRQoL when added to usual care in patients with SLE. Trial Registration: ClinicalTrials.gov NCT03426384; https://clinicaltrials.gov/ct2/show/NCT03426384 %M 33079070 %R 10.2196/23868 %U https://www.jmir.org/2020/10/e23868 %U https://doi.org/10.2196/23868 %U http://www.ncbi.nlm.nih.gov/pubmed/33079070 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e16255 %T Tailored Web-Based Smoking Interventions and Reduced Attrition: Systematic Review and Meta-Analysis %A Shah,Amika %A Chaiton,Michael %A Baliunas,Dolly %A Schwartz,Robert %+ Dalla Lana School of Public Health, University of Toronto, 155 College St, Toronto, ON, M5S 2S1, Canada, 1 416 978 7096, michael.chaiton@camh.ca %K internet %K world wide web %K smoking cessation %K web-based intervention %D 2020 %7 19.10.2020 %9 Review %J J Med Internet Res %G English %X Background: The increasing number of internet users presents an opportunity to deliver health interventions to large populations. Despite their potential, many web-based interventions, including those for smoking cessation, face high rates of attrition. Further consideration of how intervention features impact attrition is needed. Objective: The aim of this systematic review is to investigate whether tailored web-based smoking cessation interventions for smokers are associated with reduced rates of attrition compared with active or passive untailored web-based interventions. The outcomes of interest were dropout attrition at 1-, 3-, 6-, and 12-month follow-ups. Methods: Literature searches were conducted in May 2018 and updated in May 2020 on MEDLINE (Medical Literature Analysis and Retrieval System Online), PsycINFO (Psychological Information), EMBASE (Excerpta Medica dataBASE), CINAHL (Cumulated Index to Nursing and Allied Health Literature), Scopus, and the Cochrane Tobacco Addiction Group Specialized Register with the following search terms: smoking cessation, tailored, or web- or internet-based. Included studies were published in English before or in May 2020 using a randomized controlled trial design. Studies were restricted to those with web-based delivery, a tailored intervention group, an untailored control group, and a reported outcome of smoking cessation. Studies were assessed for methodological quality using the Cochrane Risk of Bias tool. Two reviewers independently extracted the study characteristics and the number of participants lost to follow-up for each treatment group. Results: A total of 13 studies were included in the systematic review, of which 11 (85%) were included in the meta-analysis. Tailoring had no statistically significant effect on dropout attrition at 1-month (risk ratio [RR]=1.02, 95% CI 0.95-1.09; P=.58; I2=78%), 3-month (RR=0.99, 95% CI 0.95-1.04; P=.80; I2=73%), 6-month (RR=1.00, 95% CI 0.95-1.05; P=.90; I2=43%), or 12-month (RR=0.97, 95% CI 0.92-1.02; P=.26; I2=28%) follow-ups. Subgroup analyses suggested that there was a statistically significant effect of tailoring between the active and passive subgroups at 1-month (P=.03), 3-month (P<.001), and 6-month (P=.02) follow-ups but not at 12-month follow-up (P=.25). Conclusions: The results suggest that tailoring of web-based smoking cessation interventions may not be associated with reduced rates of dropout attrition at 1-, 3-, 6-, or 12-month follow-ups. Significant differences between studies that include untailored active and passive control groups suggest that the role of tailoring may be more prominent when studies include a passive control group. These findings may be because of variability in the presence of additional features, the definition of smokers used, and the duration of smoking abstinence measured. Future studies should incorporate active web-based controls, compare the impact of different tailoring strategies, and include populations outside of the Western countries. %M 33074158 %R 10.2196/16255 %U https://www.jmir.org/2020/10/e16255 %U https://doi.org/10.2196/16255 %U http://www.ncbi.nlm.nih.gov/pubmed/33074158 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e17720 %T Identifying the Value of an eHealth Intervention Aimed at Cognitive Impairments: Observational Study in Different Contexts and Service Models %A Jurkeviciute,Monika %A van Velsen,Lex %A Eriksson,Henrik %A Lifvergren,Svante %A Trimarchi,Pietro Davide %A Andin,Ulla %A Svensson,Johan %+ Centre for Healthcare Improvement, Chalmers University of Technology, Vera Sandbergs Allé 8, Gothenburg, 41296, Sweden, 46 766061558, monika.jurkeviciute@chalmers.se %K eHealth value %K evaluation of value %K eHealth intervention %K cognitive impairment %K role of context %K cost benefit %D 2020 %7 8.10.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Value is one of the central concepts in health care, but it is vague within the field of summative eHealth evaluations. Moreover, the role of context in explaining the value is underexplored, and there is no explicit framework guiding the evaluation of the value of eHealth interventions. Hence, different studies conceptualize and operationalize value in different ways, ranging from measuring outcomes such as clinical efficacy or behavior change of patients or professionals to measuring the perceptions of various stakeholders or in economic terms. Objective: The objective of our study is to identify contextual factors that determine similarities and differences in the value of an eHealth intervention between two contexts. We also aim to reflect on and contribute to the discussion about the specification, assessment, and relativity of the “value” concept in the evaluation of eHealth interventions. Methods: The study concerned a 6-month eHealth intervention targeted at elderly patients (n=107) diagnosed with cognitive impairment in Italy and Sweden. The intervention introduced a case manager role and an eHealth platform to provide remote monitoring and coaching services to the patients. A model for evaluating the value of eHealth interventions was designed as monetary and nonmonetary benefits and sacrifices, based on the value conceptualizations in eHealth and marketing literature. The data was collected using the Mini–Mental State Examination (MMSE), the clock drawing test, and the 5-level EQ-5D (EQ-5D-5L). Semistructured interviews were conducted with patients and health care professionals. Monetary data was collected from the health care and technology providers. Results: The value of an eHealth intervention applied to similar types of populations but differed in different contexts. In Sweden, patients improved cognitive performance (MMSE mean 0.85, SD 1.62, P<.001), reduced anxiety (EQ-5D-5L mean 0.16, SD 0.54, P=.046), perceived their health better (EQ-5D-5L VAS scale mean 2.6, SD 9.7, P=.035), and both patients and health care professionals were satisfied with the care. However, the Swedish service model demonstrated an increased cost, higher workload for health care professionals, and the intervention was not cost-efficient. In Italy, the patients were satisfied with the care received, and the health care professionals felt empowered and had an acceptable workload. Moreover, the intervention was cost-effective. However, clinical efficacy and quality of life improvements have not been observed. We identified 6 factors that influence the value of eHealth intervention in a particular context: (1) service delivery design of the intervention (process of delivery), (2) organizational setup of the intervention (ie, organizational structure and professionals involved), (3) cost of different treatments, (4) hourly rates of staff for delivering the intervention, (5) lifestyle habits of the population (eg, how physically active they were in their daily life and if they were living alone or with family), and (6) local preferences on the quality of patient care. Conclusions: Value in the assessments of eHealth interventions need to be considered beyond economic terms, perceptions, or behavior changes. To obtain a holistic view of the value created, it needs to be operationalized into monetary and nonmonetary outcomes, categorizing these into benefits and sacrifices. %M 33064089 %R 10.2196/17720 %U http://www.jmir.org/2020/10/e17720/ %U https://doi.org/10.2196/17720 %U http://www.ncbi.nlm.nih.gov/pubmed/33064089 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e22326 %T Internet-Based Multimodal Pain Program With Telephone Support for Adults With Chronic Temporomandibular Disorder Pain: Randomized Controlled Pilot Trial %A Lam,Julia %A Svensson,Peter %A Alstergren,Per %+ Department of Orofacial Pain and Jaw Function, Faculty of Odontology, Malmö universitet, Malmö, 205 06, Sweden, 46 767690002, Julia.lam@mau.se %K chronic pain %K cognitive behavior therapy %K combined modality therapy %K facial pain %K feasibility studies %K health services research %K internet-based intervention %K occlusal splints %K pilot projects %K temporomandibular disorders %D 2020 %7 13.10.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic pain from temporomandibular disorders remains an undertreated condition with debate regarding the most effective treatment modalities. Objective: The aim of the study was to investigate the treatment effect of an internet-based multimodal pain program on chronic temporomandibular disorder pain and evaluate the feasibility of a larger randomized controlled trial. Methods: An unblinded randomized controlled pilot trial was conducted with 43 participants (34 females, 9 males; median age 27, IQR 23-37 years) with chronic temporomandibular pain. Participants were recruited within the Public Dental Health Service and randomized to intervention (n=20) or active control (n=23). The intervention comprised a dentist-assisted internet-based multimodal pain program with 7 modules based on cognitive behavior therapy and self-management principles. The control group received conventional occlusal splint therapy. Primary outcomes included characteristic pain intensity, pain-related disability, and jaw functional limitation. Secondary outcomes were depression, anxiety, catastrophizing, and stress. Outcomes were self-assessed through questionnaires sent by mail at 3 and 6 months after treatment start. Feasibility evaluation included testing the study protocol and estimation of recruitment and attrition rates in the current research setting. Results: Only 49% of participants (21/43) provided data at the 6-month follow-up (internet-based multimodal pain program: n=7; control: n=14). Of the 20 participants randomized to the internet-based multimodal pain program, 14 started treatment and 8 completed all 7 modules of the program. Between-group analysis showed no significant difference for any outcome measure at 3- or 6-month follow-up—characteristic pain intensity (3 months: P=.58; 6 months: P=.41), pain-related disability (3 months: P=.51; 6 months: P=.12), jaw functional limitation (3 months: P=.45; 6 months: P=.90), degree of depression (3 months: P=.64; 6 months: P=.65), anxiety (3 months: P=.93; 6 months: P=.31), stress (3 months: P=.66; 6 months: P=.74), or catastrophizing (3 months: P=.86; 6 months: P=.85). Within-group analysis in the internet-based multimodal pain program group showed a significant reduction in jaw functional limitation score at the 6-month follow-up compared to baseline (Friedman: χ2=10.2, P=.04; Wilcoxon: z=–2.3, P=.02). In the occlusal splint group, jaw function limitation was also reduced at the 6-month follow-up (Friedman: χ2=20.0, P=.045; Wilcoxon: z=–2.3, P=.02), and there was a reduction in characteristic pain intensity at the 3- and 6-month follow-up (Friedman: χ2=25.1, P=.01; Wilcoxon 3 months: z=–3.0, P=.003; Wilcoxon 6 months: z=-3.3, P=.001). Conclusions: This study was not able to demonstrate a difference in treatment outcome between an internet-based multimodal pain program and occlusal splint therapy in patients with chronic temporomandibular pain. However, the findings suggested that the internet-based multimodal pain program improves jaw function. The results also confirmed the treatment effect of occlusal splint therapy for chronic temporomandibular pain. Furthermore, because of the high attrition rate, this pilot study showed that a randomized controlled trial with this design is not feasible. Trial Registration: ClinicalTrials.gov NCT04363762; https://clinicaltrials.gov/show/NCT04363762 %M 33048053 %R 10.2196/22326 %U http://www.jmir.org/2020/10/e22326/ %U https://doi.org/10.2196/22326 %U http://www.ncbi.nlm.nih.gov/pubmed/33048053 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e23954 %T Fitbit-Based Interventions for Healthy Lifestyle Outcomes: Systematic Review and Meta-Analysis %A Ringeval,Mickael %A Wagner,Gerit %A Denford,James %A Paré,Guy %A Kitsiou,Spyros %+ Research Chair in Digital Health, HEC Montreal, 3000, Cote-Sainte-Catherine Road, Montreal, QC, H1Y3K9, Canada, 1 514 882 8672, guy.pare@hec.ca %K Fitbit %K wearables %K healthy lifestyle %K meta-analysis %K literature review %K fuzzy-set qualitative comparative analysis %D 2020 %7 12.10.2020 %9 Review %J J Med Internet Res %G English %X Background: Unhealthy behaviors, such as physical inactivity, sedentary lifestyle, and unhealthful eating, remain highly prevalent, posing formidable challenges in efforts to improve cardiovascular health. While traditional interventions to promote healthy lifestyles are both costly and effective, wearable trackers, especially Fitbit devices, can provide a low-cost alternative that may effectively help large numbers of individuals become more physically fit and thereby maintain a good health status. Objective: The objectives of this meta-analysis are (1) to assess the effectiveness of interventions that incorporate a Fitbit device for healthy lifestyle outcomes (eg, steps, moderate-to-vigorous physical activity, and weight) and (2) to identify which additional intervention components or study characteristics are the most effective at improving healthy lifestyle outcomes. Methods: A systematic review was conducted, searching the following databases from 2007 to 2019: MEDLINE, EMBASE, CINAHL, and CENTRAL (Cochrane). Studies were included if (1) they were randomized controlled trials, (2) the intervention involved the use of a Fitbit device, and (3) the reported outcomes were related to healthy lifestyles. The main outcome measures were related to physical activity, sedentary behavior, and weight. All the studies were assessed for risk of bias using Cochrane criteria. A random-effects meta-analysis was conducted to estimate the treatment effect of interventions that included a Fitbit device compared with a control group. We also conducted subgroup analysis and fuzzy-set qualitative comparative analysis (fsQCA) to further disentangle the effects of intervention components. Results: Our final sample comprised 41 articles reporting the results of 37 studies. For Fitbit-based interventions, we found a statistically significant increase in daily step count (mean difference [MD] 950.54, 95% CI 475.89-1425.18; P<.001) and moderate-to-vigorous physical activity (MD 6.16, 95% CI 2.80-9.51; P<.001), a significant decrease in weight (MD −1.48, 95% CI −2.81 to −0.14; P=.03), and a nonsignificant decrease in objectively assessed and self-reported sedentary behavior (MD −10.62, 95% CI −35.50 to 14.27; P=.40 and standardized MD −0.11, 95% CI −0.48 to 0.26; P=.56, respectively). In general, the included studies were at low risk for bias, except for performance bias. Subgroup analysis and fsQCA demonstrated that, in addition to the effects of the Fitbit devices, setting activity goals was the most important intervention component. Conclusions: The use of Fitbit devices in interventions has the potential to promote healthy lifestyles in terms of physical activity and weight. Fitbit devices may be useful to health professionals for patient monitoring and support. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42019145450; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42019145450 %M 33044175 %R 10.2196/23954 %U http://www.jmir.org/2020/10/e23954/ %U https://doi.org/10.2196/23954 %U http://www.ncbi.nlm.nih.gov/pubmed/33044175 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e18447 %T Experiences of Serving and Ex-Serving Members With the PTSD Coach Australia App: Mixed Methods Study %A Shakespeare-Finch,Jane %A Alichniewicz,Karolina K %A Strodl,Esben %A Brown,Kelly %A Quinn,Catherine %A Hides,Leanne %A White,Angela %A Gossage,Gabrial %A Poerio,Loretta %A Batras,Dimitri %A Jackson,Samantha %A Styles,Jess %A Kavanagh,David %+ Queensland University of Technology, Victoria Park Road, Kelvin Grove, Brisbane, 4059, Australia, 61 0731384932, j.shakespeare-finch@qut.edu.au %K PTSD %K stress disorders, posttraumatic %K self-management %K evaluation, qualitative %K health, veterans %K armed forces personnel %D 2020 %7 8.10.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: PTSD Coach Australia is an app for serving and ex-serving defense members and was adapted for the Australian context in 2013 from PTSD Coach, which was created in the United States. Objective: This study aimed to provide a user-centered evaluation of the app from the perspective of serving and ex-serving members of the Australian Defence Force. Methods: Qualitative data were collected in response to questions to participants in 1 of 5 workshops (n=29) or in telephone interviews (n=24). Quantitative data were collected using the user version of Mobile Apps Rating Scale (uMARS). Results: Analysis of the qualitative data demonstrated mixed support for the app. While some people found it extremely useful, especially as an adjunct to therapy, others pointed out limitations and cautioned against the app potentially triggering symptoms in people with PTSD. This perceived risk was usually found to stem from frustration with the app’s functionality rather than its content. Participants spoke about the helpful and unhelpful aspects of the app and barriers to its use and made suggestions for improvement. Many participants encouraged its continued use and highlighted the need for it to be promoted more broadly, as many were not aware of it until they were invited to participate in this research. Conclusions: PTSD Coach Australia was seen in a positive light by some participants, but others thought it had too much text and the potential to trigger a traumatic response in users with PTSD. A need to update the app was also a common comment as was the need to increase awareness of the app’s existence. %M 33030438 %R 10.2196/18447 %U https://www.jmir.org/2020/10/e18447 %U https://doi.org/10.2196/18447 %U http://www.ncbi.nlm.nih.gov/pubmed/33030438 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e23024 %T Effectiveness of a Participatory and Interactive Virtual Reality Intervention in Patients With Social Anxiety Disorder: Longitudinal Questionnaire Study %A Kim,Hyun-Jin %A Lee,Seulki %A Jung,Dooyoung %A Hur,Ji-Won %A Lee,Heon-Jeong %A Lee,Sungkil %A Kim,Gerard J %A Cho,Chung-Yean %A Choi,Seungmoon %A Lee,Seung-Moo %A Cho,Chul-Hyun %+ Department of Psychiatry, College of Medicine, Chungnam National University, 82 Munhwa-ro, Jung-gu, Daejeon, 35015, Republic of Korea, 82 449954775, david0203@gmail.com %K anxiety %K social anxiety disorder %K virtual reality %K intervention %K effectiveness %K questionnaires %D 2020 %7 6.10.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Social anxiety disorder (SAD) is characterized by excessive fear of negative evaluation and humiliation in social interactions and situations. Virtual reality (VR) treatment is a promising intervention option for SAD. Objective: The purpose of this study was to create a participatory and interactive VR intervention for SAD. Treatment progress, including the severity of symptoms and the cognitive and emotional aspects of SAD, was analyzed to evaluate the effectiveness of the intervention. Methods: In total, 32 individuals with SAD and 34 healthy control participants were enrolled in the study through advertisements for online bulletin boards at universities. A VR intervention was designed consisting of three stages (introduction, core, and finishing) and three difficulty levels (easy, medium, and hard) that could be selected by the participants. The core stage was the exposure intervention in which participants engaged in social situations. The effectiveness of treatment was assessed through Beck Anxiety inventory (BAI), State‐Trait Anxiety Inventory (STAI), Internalized Shame Scale (ISS), Post-Event Rumination Scale (PERS), Social Phobia Scale (SPS), Social Interaction Anxiety Scale (SIAS), Brief-Fear of Negative Evaluation Scale (BFNE), and Liebowitz Social Anxiety Scale (LSAS). Results: In the SAD group, scores on the BAI (F=4.616, P=.009), STAI-Trait (F=4.670, P=.004), ISS (F=6.924, P=.001), PERS-negative (F=1.008, P<.001), SPS (F=8.456, P<.001), BFNE (F=6.117, P=.004), KSAD (F=13.259, P<.001), and LSAS (F=4.103, P=.009) significantly improved over the treatment process. Compared with the healthy control group before treatment, the SAD group showed significantly higher scores on all scales (P<.001), and these significant differences persisted even after treatment (P<.001). In the comparison between the VR treatment responder and nonresponder subgroups, there was no significant difference across the course of the VR session. Conclusions: These findings indicated that a participatory and interactive VR intervention had a significant effect on alleviation of the clinical symptoms of SAD, confirming the usefulness of VR for the treatment of SAD. VR treatment is expected to be one of various beneficial therapeutic approaches in the future. Trial Registration: Clinical Research Information Service (CRIS) KCT0003854; https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=13508 %M 33021481 %R 10.2196/23024 %U http://www.jmir.org/2020/10/e23024/ %U https://doi.org/10.2196/23024 %U http://www.ncbi.nlm.nih.gov/pubmed/33021481 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 7 %N 10 %P e22833 %T Preliminary Outcomes of a Digital Therapeutic Intervention for Smoking Cessation in Adult Smokers: Randomized Controlled Trial %A Webb,Jamie %A Peerbux,Sarrah %A Smittenaar,Peter %A Siddiqui,Sarim %A Sherwani,Yusuf %A Ahmed,Maroof %A MacRae,Hannah %A Puri,Hannah %A Bhalla,Sangita %A Majeed,Azeem %+ Digital Therapeutics Inc, ‍2443 Fillmore St, San Francisco, CA, 94115, United States, 1 650 684 5503, jamie@quitgenius.com %K digital %K smoking %K cessation %K mobile %K randomized controlled trial %K app %K mobile phone %K mHealth %D 2020 %7 6.10.2020 %9 Original Paper %J JMIR Ment Health %G English %X Background: Tobacco smoking remains the leading cause of preventable death and disease worldwide. Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness. Objective: Our objective was to test the preliminary effectiveness of Quit Genius, a novel digital therapeutic intervention for smoking cessation. Methods: A 2-arm, single-blinded, parallel-group randomized controlled trial design was used. Participants were recruited via referrals from primary care practices and social media advertisements in the United Kingdom. A total of 556 adult smokers (aged 18 years or older) smoking at least 5 cigarettes a day for the past year were recruited. Of these, 530 were included for the final analysis. Participants were randomized to one of 2 interventions. Treatment consisted of a digital therapeutic intervention for smoking cessation consisting of a smartphone app delivering cognitive behavioral therapy content, one-to-one coaching, craving tools, and tracking capabilities. The control intervention was very brief advice along the Ask, Advise, Act model. All participants were offered nicotine replacement therapy for 3 months. Participants in a random half of each arm were pseudorandomly assigned a carbon monoxide device for biochemical verification. Outcomes were self-reported via phone or online. The primary outcome was self-reported 7-day point prevalence abstinence at 4 weeks post quit date. Results: A total of 556 participants were randomized (treatment: n=277; control: n=279). The intention-to-treat analysis included 530 participants (n=265 in each arm; 11 excluded for randomization before trial registration and 15 for protocol violations at baseline visit). By the quit date (an average of 16 days after randomization), 89.1% (236/265) of those in the treatment arm were still actively engaged. At the time of the primary outcome, 74.0% (196/265) of participants were still engaging with the app. At 4 weeks post quit date, 44.5% (118/265) of participants in the treatment arm had not smoked in the preceding 7 days compared with 28.7% (76/265) in the control group (risk ratio 1.55, 95% CI 1.23-1.96; P<.001; intention-to-treat, n=530). Self-reported 7-day abstinence agreed with carbon monoxide measurement (carbon monoxide <10 ppm) in 96% of cases (80/83) where carbon monoxide readings were available. No harmful effects of the intervention were observed. Conclusions: The Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 65853476; https://www.isrctn.com/ISRCTN65853476 %M 33021488 %R 10.2196/22833 %U https://mental.jmir.org/2020/10/e22833 %U https://doi.org/10.2196/22833 %U http://www.ncbi.nlm.nih.gov/pubmed/33021488 %0 Journal Article %@ 2291-9694 %I JMIR Publications %V 8 %N 10 %P e16077 %T Personalized Web-Based Cognitive Rehabilitation Treatments for Patients with Traumatic Brain Injury: Cluster Analysis %A Garcia-Rudolph,Alejandro %A Garcia-Molina,Alberto %A Opisso,Eloy %A Tormos Muñoz,Jose %+ Institut Guttmann Hospital de Neurorehabilitacio, Cami de Can Ruti s/n, Badalona, Spain, 34 93 497 77 00, alejandropablogarcia@gmail.com %K cluster analysis %K traumatic brain injury %K web-based rehabilitation %D 2020 %7 6.10.2020 %9 Original Paper %J JMIR Med Inform %G English %X Background: Traumatic brain injury (TBI) is a leading cause of disability worldwide. TBI is a highly heterogeneous disease, which makes it complex for effective therapeutic interventions. Cluster analysis has been extensively applied in previous research studies to identify homogeneous subgroups based on performance in neuropsychological baseline tests. Nevertheless, most analyzed samples are rarely larger than a size of 100, and different cluster analysis approaches and cluster validity indices have been scarcely compared or applied in web-based rehabilitation treatments. Objective: The aims of our study were as follows: (1) to apply state-of-the-art cluster validity indices to different cluster strategies: hierarchical, partitional, and model-based, (2) to apply combined strategies of dimensionality reduction by using principal component analysis and random forests and perform stability assessment of the final profiles, (3) to characterize the identified profiles by using demographic and clinically relevant variables, and (4) to study the external validity of the obtained clusters by considering 3 relevant aspects of TBI rehabilitation: Glasgow Coma Scale, functional independence measure, and execution of web-based cognitive tasks. Methods: This study was performed from August 2008 to July 2019. Different cluster strategies were executed with Mclust, factoextra, and cluster R packages. For combined strategies, we used the FactoMineR and random forest R packages. Stability analysis was performed with the fpc R package. Between-group comparisons for external validation were performed using 2-tailed t test, chi-square test, or Mann-Whitney U test, as appropriate. Results: We analyzed 574 adult patients with TBI (mostly severe) who were undergoing web-based rehabilitation. We identified and characterized 3 clusters with strong internal validation: (1) moderate attentional impairment and moderate dysexecutive syndrome with mild memory impairment and normal spatiotemporal perception, with almost 66% (111/170) of the patients being highly educated (P<.05); (2) severe dysexecutive syndrome with severe attentional and memory impairments and normal spatiotemporal perception, with 49.2% (153/311) of the patients being highly educated (P<.05); (3) very severe cognitive impairment, with 45.2% (42/93) of the patients being highly educated (P<.05). We externally validated them with severity of injury (P=.006) and functional independence assessments: cognitive (P<.001), motor (P<.001), and total (P<.001). We mapped 151,763 web-based cognitive rehabilitation tasks during the whole period to the 3 obtained clusters (P<.001) and confirmed the identified patterns. Stability analysis indicated that clusters 1 and 2 were respectively rated as 0.60 and 0.75; therefore, they were measuring a pattern and cluster 3 was rated as highly stable. Conclusions: Cluster analysis in web-based cognitive rehabilitation treatments enables the identification and characterization of strong response patterns to neuropsychological tests, external validation of the obtained clusters, tailoring of cognitive web-based tasks executed in the web platform to the identified profiles, thereby providing clinicians a tool for treatment personalization, and the extension of a similar approach to other medical conditions. %M 33021482 %R 10.2196/16077 %U https://medinform.jmir.org/2020/10/e16077 %U https://doi.org/10.2196/16077 %U http://www.ncbi.nlm.nih.gov/pubmed/33021482 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e16782 %T Mechanisms of Action of a Web-Based Intervention With Health Professional Support to Increase Adherence to Nebulizer Treatments in Adults With Cystic Fibrosis: Qualitative Interview Study %A Drabble,Sarah J %A O'Cathain,Alicia %A Scott,Alexander J %A Arden,Madelynne A %A Keating,Samuel %A Hutchings,Marlene %A Maguire,Chin %A Wildman,Martin %+ School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent St, Sheffield, S1 4DA, United Kingdom, 44 07711973986, s.j.drabble@sheffield.ac.uk %K United Kingdom %K cystic fibrosis %K adherence %K compliance %K health behavior %K psychological theory %K process evaluation %K qualitative research %K interview %K patient portals %K telehealth %D 2020 %7 6.10.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Adherence to nebulizer treatments in adults with cystic fibrosis (CF) is often low. A new complex intervention to help adults with CF increase their adherence to nebulizer treatments was tested in a pilot randomized controlled trial (RCT) in 2 UK CF centers. Patients used a nebulizer with electronic monitoring capabilities that transferred data automatically to a digital platform (CFHealthHub) to monitor adherence over time and to a tailored website to display graphs of adherence data and educational and problem-solving information about adherence. A trained interventionist helped patients identify ways to increase their adherence. Objective: This study aims to explore the mechanisms of action underpinning the intervention. Methods: A qualitative interview study was conducted concurrently with a pilot RCT. In total, 25 semistructured interviews were conducted with 3 interventionists at 2 time points, 14 patients in the intervention arm of the trial, and 5 members of the multidisciplinary teams offering wider care to patients. A framework approach was used for the analysis. Results: The intervention was informed by a theoretical framework of behavior change. There was evidence of the expected behavior change mechanisms of action. There was also evidence of additional mechanisms of action associated with effective telehealth interventions for self-management support: relationships, visibility, and fit. Patients described how building a relationship with the interventionist through face-to-face visits with someone who cared about them and their progress helped them to consider ways of increasing adherence to medication. Rather than seeing the visibility of adherence data to clinicians as problematic, patients found this motivating, particularly if they received praise about progress made. The intervention was tailored to individuals, but there were challenges in how the intervention fitted into some patients’ busy lives when delivered through a desktop computer. Conclusions: The mechanisms of action associated with effective telehealth interventions for self-management operated within this new intervention. The intervention was modified to strengthen mechanisms of action based on these findings, for example, delivery through an app accessed via mobile phones and then tested in an RCT in 19 UK CF centers. Trial Registration: International Standard Randomized Controlled Trial Number 13076797; http://www.isrctn.com/ISRCTN13076797 %M 32697197 %R 10.2196/16782 %U https://www.jmir.org/2020/10/e16782 %U https://doi.org/10.2196/16782 %U http://www.ncbi.nlm.nih.gov/pubmed/32697197 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e21336 %T Twelve-Month Follow-Up to a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention for Rural Adults With Depression Symptoms: Single-Arm Longitudinal Study %A Schure,Mark %A McCrory,Bernadette %A Tuchscherer Franklin,Kathryn %A Greist,John %A Weissman,Ruth Striegel %+ Department of Health & Human Development, Montana State University, 305 Herrick Hall, Bozeman, MT, 59717, United States, 1 406 994 3248, mark.schure@montana.edu %K internet-based cognitive behavior therapy %K depression %K anxiety %K long-term outcomes %K iCBT %K CBT %K therapy %K mental health %K outcome %D 2020 %7 2.10.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-based cognitive behavior therapy (iCBT) interventions have the potential to help individuals with depression, regardless of time and location. Yet, limited information exists on the longer-term (>6 months) effects of iCBT and adherence to these interventions. Objective: The primary aim of this study was to evaluate the longitudinal (12 months) effectiveness of a fully automated, self-guided iCBT intervention called Thrive, designed to enhance engagement with a rural population of adults with depression symptoms. The secondary aim was to determine whether the program adherence enhanced the effectiveness of the Thrive intervention. Methods: We analyzed data from 181 adults who used the Thrive intervention. Using self-reports, participants were evaluated at baseline, 8 weeks, 6 months, and 12 months for the primary outcome of depression symptom severity using the Patient Health Questionnaire-9 (PHQ-9) scale and secondary outcome measures, namely, the Generalized Anxiety Disorder Scale-7 (GAD-7) scores, Work and Social Adjustment Scale (WSAS) scores, Conner-Davidson Resilience Scale-10 (CD-RISC-10) scores, and suicidal ideation (ninth item of the PHQ-9 scale) scores. The Thrive program adherence was measured using the numbers of program logins, page views, and lessons completed. Results: The assessment response rates for 8-week, 6-month, and 12-month outcomes were 58.6% (106/181), 50.3% (91/181), and 51.4% (93/181), respectively. By 8 weeks, significant improvements were observed for all outcome measures. These improvements were maintained at 12 months with mean reductions in severities of depression (mean –6.5; P<.001) and anxiety symptoms (mean –4.3; P<.001). Improvements were also observed in work and social functioning (mean –6.9; P<.001) and resilience (mean 4.3; P<.001). Marked decreases were observed in suicidal ideation (PHQ-9 ninth item score >1) at 6 months (16.5%) and 12 months (17.2%) compared to baseline (39.8%) (P<.001). In regard to the program adherence, cumulative counts of page views and lessons completed were significantly related to lower PHQ-9, GAD-7, and WSAS scores and higher CD-RISC-10 scores (all P values <.001 with an exception of page views with WSAS for which P value was .02). Conclusions: The Thrive intervention was effective at reducing depression and anxiety symptom severity and improving functioning and resilience among a population of adults from mostly rural communities in the United States. These gains were maintained at 1 year. Program adherence, measured by the number of logins and lessons completed, indicates that users who engage more with the program benefit more from the intervention. Trial Registration: ClinicalTrials.gov NCT03244878; https://clinicaltrials.gov/ct2/show/NCT03244878 %M 33006561 %R 10.2196/21336 %U https://www.jmir.org/2020/10/e21336 %U https://doi.org/10.2196/21336 %U http://www.ncbi.nlm.nih.gov/pubmed/33006561 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e17526 %T Predictors and Effects of Usage of an Online Mindfulness Intervention for Distressed Cancer Patients: Usability Study %A Cillessen,Linda %A van de Ven,Monique OM %A Compen,Félix R %A Bisseling,Else M %A van der Lee,Marije L %A Speckens,Anne EM %+ Department of Psychiatry, Center for Mindfulness, Radboud University Medical Center, Postbus 9101, Nijmegen, 6500 HB, Netherlands, 31 (0)24 361 5445, linda.cillessen@radboudumc.nl %K internet intervention %K eHealth %K mindfulness %K mindfulness-based cognitive therapy %K usage %K log data %K uptake %K adherence %K cancer %K oncology %D 2020 %7 2.10.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: One in three cancer patients experience high psychological distress. Mindfulness-based interventions are effective in reducing psychological distress in this patient group. However, these interventions lack availability and flexibility, which may compromise participation in the intervention for cancer patients experiencing late symptoms like fatigue or pain. Therefore, mindfulness-based interventions are increasingly offered via the internet. However, little is known about the usage of these online mindfulness-based interventions. Objective: The aim of this study was to (1) predict uptake of and adherence to online mindfulness-based cognitive therapy (eMBCT) using baseline patient characteristics (demographic, cancer-related, personality, and psychological variables) and (2) examine the relations between adherence and treatment outcomes in eMBCT for cancer patients. Methods: A total of 125 cancer patients were assigned to eMBCT in a parent randomized controlled trial comparing MBCT and eMBCT with treatment as usual in distressed cancer patients. Various usage measures of eMBCT were automatically tracked within the online program. Based on activity of use, participants were classified as nonusers, minimal users, low users, and intended users. Questionnaires were used to assess baseline characteristics (preintervention) and outcomes (pre- and postintervention). To answer the research questions, data were analyzed with t tests, χ2 tests, and linear regression models. Results: Based on weekly activity, participants were classified as nonusers (n=17, 13.6%), who completed no exercises in MBCT; minimal users (n=31, 24.8%), who completed at least one exercise of one to three sessions; low users (n=12, 9.6%), who completed at least one exercise of four to seven sessions; and intended users (n=65, 52.0%), who completed at least one exercise of eight to nine sessions. Nonusers had more fear of cancer recurrence at baseline than users (uptake), and intended users were more conscientious than minimal and low users (adherence). Intended users reported a larger reduction in psychological distress and more improvement of positive mental health (ie, emotional, psychological, and social well-being) after the intervention than other participants. Conclusions: This study showed that adherence was related to improved patient outcomes. Patients with strong fear of recurrence or low levels of conscientiousness should receive extra attention, as they are less likely to respectively start or complete eMBCT. Future research may focus on the development of flexible and adaptive eMBCT programs to fit individual needs. %M 33006567 %R 10.2196/17526 %U https://www.jmir.org/2020/10/e17526 %U https://doi.org/10.2196/17526 %U http://www.ncbi.nlm.nih.gov/pubmed/33006567 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e22811 %T Assessment of a Personal Interactive Carbon Monoxide Breath Sensor in People Who Smoke Cigarettes: Single-Arm Cohort Study %A Marler,Jennifer D %A Fujii,Craig A %A Wong,Kristine S %A Galanko,Joseph A %A Balbierz,Daniel J %A Utley,David S %+ Carrot Inc., 1400A Seaport Blvd., Ste. 501, Redwood City, CA, 94063, United States, 1 4157577696, marler@carrot.co %K smoking cessation %K digital health %K smartphone %K digital sensor %K carbon monoxide %K breath sensor %K biofeedback %D 2020 %7 2.10.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Tobacco use is the leading cause of preventable morbidity and mortality. Existing evidence-based treatments are underutilized and have seen little recent innovation. The success of personal biofeedback interventions in other disease states portends a similar opportunity in smoking cessation. The Pivot Breath Sensor is a personal interactive FDA-cleared (over-the-counter) device that measures carbon monoxide (CO) in exhaled breath, enabling users to link their smoking behavior and CO values, and track their progress in reducing or quitting smoking. Objective: The objective of this study is to assess the Pivot Breath Sensor in people who smoke cigarettes, evaluating changes in attitudes toward quitting smoking, changes in smoking behavior, and use experience. Methods: US adults (18-80 years of age, ≥10 cigarettes per day [CPD]) were recruited online for this remote 12-week study. Participants completed a screening call, informed consent, and baseline questionnaire, and then were mailed their sensor. Participants were asked to submit 4 or more breath samples per day and complete questionnaires at 1-4, 8, and 12 weeks. Outcomes included attitudes toward quitting smoking (Stage of Change, success to quit, and perceived difficulty of quitting), smoking behavior (quit attempts, CPD reduction, and 7-, 30-day point prevalence abstinence [PPA]), and use experience (impact and learning). Results: Participants comprised 234 smokers, mean age 39.9 (SD 11.3) years, 52.6% (123/234) female, mean CPD 20.3 (SD 8.0). The 4- and 12-week questionnaires were completed by 92.3% (216/234) and 91.9% (215/234) of participants, respectively. Concerning attitude outcomes, at baseline, 15.4% (36/234) were seriously thinking of quitting in the next 30 days, increasing to 38.9% (84/216) at 4 weeks and 47.9% (103/215) at 12 weeks (both P<.001). At 12 weeks, motivation to quit was increased in 39.1% (84/215), unchanged in 54.9% (118/215), and decreased in 6.0% (13/215; P<.001). Additional attitudes toward quitting improved from baseline to 12 weeks: success to quit 3.3 versus 5.0 (P<.001) and difficulty of quitting 2.8 versus 4.3 (P<.001). Regarding smoking behavior, at 4 weeks, 28.2% (66/234) had made 1 or more quit attempts (≥1 day of abstinence), increasing to 48.3% (113/234) at 12 weeks. At 4 weeks, 23.1% (54/234) had reduced CPD by 50% or more, increasing to 38.5% (90/234) at 12 weeks. At 12 weeks, CPD decreased by 41.1% from baseline (P<.001), and 7- and 30-day PPA were 12.0% (28/234) and 6.0% (14/234), respectively. Concerning use experience, 75.3% (171/227) reported the sensor increased their motivation to quit. More than 90% (>196/214) indicated the sensor taught them about their CO levels and smoking behavior, and 73.1% (166/227) reported that seeing their CO values made them want to quit smoking. Conclusions: Use of the Pivot Breath Sensor resulted in a significant increase in motivation to quit, a reduction in CPD, and favorable quit attempt rates. These outcomes confer increased likelihood of quitting smoking. Accordingly, the results support a role for biofeedback via personal CO breath sampling in smoking cessation. Trial Registration: ClinicalTrials.gov NCT04133064; https://clinicaltrials.gov/ct2/show/NCT04133064 %M 32894829 %R 10.2196/22811 %U https://www.jmir.org/2020/10/e22811 %U https://doi.org/10.2196/22811 %U http://www.ncbi.nlm.nih.gov/pubmed/32894829 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e19378 %T Impact of a Blended Periconception Lifestyle Care Approach on Lifestyle Behaviors: Before-and-After Study %A van der Windt,Melissa %A van der Kleij,Rianne Maria %A Snoek,Katinka Marianne %A Willemsen,Sten Paul %A Dykgraaf,Ramon Henny Maria %A Laven,Joop Stephanus Elisabeth %A Schoenmakers,Sam %A Steegers-Theunissen,Régine Patricia Maria %+ Department of Obstetrics and Gynecology, Erasmus University Medical Center, PO Box 2040, Rotterdam, 3000CA, Netherlands, +31 107038255, r.steegers@erasmusmc.nl %K eHealth %K periconception period %K lifestyle intervention %D 2020 %7 30.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Periconception lifestyle behaviors affect maternal, paternal, offspring, and transgenerational health outcomes. Previous research in other target populations has shown that personalized lifestyle interventions, in which face-to-face counseling and eHealth (“blended care”) are combined, may effectively target these lifestyle behaviors. Objective: We aimed to assess the effectiveness of a periconceptional lifestyle intervention on the improvement of specific lifestyle components. Methods: A blended periconception lifestyle care approach was developed, combining the outpatient lifestyle counseling service “Healthy Pregnancy” with the eHealth platform “Smarter Pregnancy” (www.smarterpregnancy.co.uk) in which lifestyle was coached for 24 weeks. All couples contemplating pregnancy or already pregnant (≤12 weeks of gestation) who visited the outpatient clinics of the Department of Obstetrics and Gynecology at the Erasmus University Medical Center (Erasmus MC), Rotterdam, the Netherlands, between June and December 2018, were invited to participate. We measured changes in lifestyle behaviors at weeks 12 and 24 compared with baseline. Generalized estimating equations were used to analyze the changes in lifestyle behaviors over time. Subgroup analyses were performed for women with obesity (BMI ≥30 kg/m2), women pregnant at the start of the intervention, and those participating as a couple. Results: A total of 539 women were screened for eligibility, and 450 women and 61 men received the blended periconception intervention. Among the participating women, 58.4% (263/450) were included in the preconception period. Moreover, 78.9% (403/511) of the included participants completed the online lifestyle coaching. At baseline, at least one poor lifestyle behavior was present in most women (379/450, 84.2%) and men (58/61, 95.1%). In the total group, median fruit intake increased from 1.8 to 2.2 pieces/day (P<.001) and median vegetable intake increased from 151 to 165 grams/day (P<.001) after 24 weeks of online coaching. The probability of taking folic acid supplementation among women increased from 0.97 to 1 (P<.001), and the probability of consuming alcohol and using tobacco in the total group decreased from 0.25 to 0.19 (P=.002) and from 0.20 to 0.15 (P=.63), respectively. Overall, the program showed the strongest effectiveness for participating couples. Particularly for vegetable and fruit intake, their consumption increased from 158 grams/day and 1.8 pieces/day at baseline to 190 grams/day and 2.7 pieces/day at the end of the intervention, respectively. Conclusions: We succeeded in including most participating women in the preconception period. A high compliance rate was achieved and users demonstrated improvements in several lifestyle components. The blended periconception lifestyle care approach seems to be an effective method to improve lifestyle behaviors. The next step is to further disseminate this approach and to perform a randomized trial to compare the use of blended care with the provision of only eHealth. Additionally, the clinical relevance of these results will need to be substantiated further. %M 32996885 %R 10.2196/19378 %U http://www.jmir.org/2020/9/e19378/ %U https://doi.org/10.2196/19378 %U http://www.ncbi.nlm.nih.gov/pubmed/32996885 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e20283 %T Rates of Attrition and Dropout in App-Based Interventions for Chronic Disease: Systematic Review and Meta-Analysis %A Meyerowitz-Katz,Gideon %A Ravi,Sumathy %A Arnolda,Leonard %A Feng,Xiaoqi %A Maberly,Glen %A Astell-Burt,Thomas %+ Western Sydney Diabetes, Western Sydney Local Health District, Blacktown Road, Blacktown NSW, , Australia, 61 2 9881 8878, gideon.meyerowitzkatz@health.nsw.gov.au %K chronic disease %K mHealth %K mobile apps %K attrition %K dropout %D 2020 %7 29.9.2020 %9 Review %J J Med Internet Res %G English %X Background: Chronic disease represents a large and growing burden to the health care system worldwide. One method of managing this burden is the use of app-based interventions; however attrition, defined as lack of patient use of the intervention, is an issue for these interventions. While many apps have been developed, there is some evidence that they have significant issues with sustained use, with up to 98% of people only using the app for a short time before dropping out and/or dropping use down to the point where the app is no longer effective at helping to manage disease. Objective: Our objectives are to systematically appraise and perform a meta-analysis on dropout rates in apps for chronic disease and to qualitatively synthesize possible reasons for these dropout rates that could be addressed in future interventions. Methods: MEDLINE (Medical Literature Analysis and Retrieval System Online), PubMed, Cochrane CENTRAL (Central Register of Controlled Trials), and Embase were searched from 2003 to the present to look at mobile health (mHealth) and attrition or dropout. Studies, either randomized controlled trials (RCTs) or observational trials, looking at chronic disease with measures of dropout were included. Meta-analysis of attrition rates was conducted in Stata, version 15.1 (StataCorp LLC). Included studies were also qualitatively synthesized to examine reasons for dropout and avenues for future research. Results: Of 833 studies identified in the literature search, 17 were included in the review and meta-analysis. Out of 17 studies, 9 (53%) were RCTs and 8 (47%) were observational trials, with both types covering a range of chronic diseases. The pooled dropout rate was 43% (95% CI 29-57), with observational studies having a higher dropout rate (49%, 95% CI 27-70) than RCTs in more controlled scenarios, which only had a 40% dropout rate (95% CI 16-63). The studies were extremely varied, which is represented statistically in the high degree of heterogeneity (I2>99%). Qualitative synthesis revealed a range of reasons relating to attrition from app-based interventions, including social, demographic, and behavioral factors that could be addressed. Conclusions: Dropout rates in mHealth interventions are high, but possible areas to minimize attrition exist. Reducing dropout rates will make these apps more effective for disease management in the long term. Trial Registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42019128737; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42019128737 %M 32990635 %R 10.2196/20283 %U http://www.jmir.org/2020/9/e20283/ %U https://doi.org/10.2196/20283 %U http://www.ncbi.nlm.nih.gov/pubmed/32990635 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e19945 %T The Influence of Three Modes of Human Support on Attrition and Adherence to a Web- and Mobile App–Based Mental Health Promotion Intervention in a Nonclinical Cohort: Randomized Comparative Study %A Renfrew,Melanie Elise %A Morton,Darren Peter %A Morton,Jason Kyle %A Hinze,Jason Scott %A Przybylko,Geraldine %A Craig,Bevan Adrian %+ Lifestyle and Health Research Centre, Avondale University College, 582 Freemans Drive, Cooranbong, NSW, Australia, 61 405445151, melanie.renfrew@avondale.edu.au %K human support %K adherence %K attrition %K engagement %K web-based mental health %K health promotion %K eHealth %K SMS %K videoconferencing %D 2020 %7 29.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: The escalating prevalence of mental health disorders necessitates a greater focus on web- and mobile app–based mental health promotion initiatives for nonclinical groups. However, knowledge is scant regarding the influence of human support on attrition and adherence and participant preferences for support in nonclinical settings. Objective: This study aimed to compare the influence of 3 modes of human support on attrition and adherence to a digital mental health intervention for a nonclinical cohort. It evaluated user preferences for support and assessed whether adherence and outcomes were enhanced when participants received their preferred support mode. Methods: Subjects participated in a 10-week digital mental health promotion intervention and were randomized into 3 comparative groups: standard group with automated emails (S), standard plus personalized SMS (S+pSMS), and standard plus weekly videoconferencing support (S+VCS). Adherence was measured by the number of video lessons viewed, points achieved for weekly experiential challenge activities, and the total number of weeks that participants recorded a score for challenges. In the postquestionnaire, participants ranked their preferred human support mode from 1 to 4 (S, S+pSMS, S+VCS, S+pSMS & VCS combined). Stratified analysis was conducted for those who received their first preference. Preintervention and postintervention questionnaires assessed well-being measures (ie, mental health, vitality, depression, anxiety, stress, life satisfaction, and flourishing). Results: Interested individuals (N=605) enrolled on a website and were randomized into 3 groups (S, n=201; S+pSMS, n=202; S+VCS, n=201). Prior to completing the prequestionnaire, a total of 24.3% (147/605) dropped out. Dropout attrition between groups was significantly different (P=.009): 21.9% (44/201) withdrew from the S group, 19.3% (39/202) from the S+pSMS group, and 31.6% (64/202) from the S+VCS group. The remaining 75.7% (458/605) registered and completed the prequestionnaire (S, n=157; S+pSMS, n=163; S+VCS, n=138). Of the registered participants, 30.1% (138/458) failed to complete the postquestionnaire (S, n=54; S+pSMS, n=49; S+VCS, n=35), but there were no between-group differences (P=.24). For the 69.9% (320/458; S, n=103; S+pSMS, n=114; S+VCS, n=103) who completed the postquestionnaire, no between-group differences in adherence were observed for mean number of videos watched (P=.42); mean challenge scores recorded (P=.71); or the number of weeks that challenge scores were logged (P=.66). A total of 56 participants (17.5%, 56/320) received their first preference in human support (S, n=22; S+pSMS, n=26; S+VCS, n=8). No differences were observed between those who received their first preference and those who did not with regard to video adherence (P=.91); challenge score adherence (P=.27); or any of the well-being measures including, mental health (P=.86), vitality (P=.98), depression (P=.09), anxiety (P=.64), stress (P=.55), life satisfaction (P=.50), and flourishing (P=.47). Conclusions: Early dropout attrition may have been influenced by dissatisfaction with the allocated support mode. Human support mode did not impact adherence to the intervention, and receiving the preferred support style did not result in greater adherence or better outcomes. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): 12619001009101; http://www.anzctr.org.au/ACTRN12619001009101.aspx %M 32990633 %R 10.2196/19945 %U http://www.jmir.org/2020/9/e19945/ %U https://doi.org/10.2196/19945 %U http://www.ncbi.nlm.nih.gov/pubmed/32990633 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e19703 %T Promoting Safe Injection Practices, Substance Use Reduction, Hepatitis C Testing, and Overdose Prevention Among Syringe Service Program Clients Using a Computer-Tailored Intervention: Pilot Randomized Controlled Trial %A Hochstatter,Karli R %A Hull,Shawnika J %A Sethi,Ajay K %A Burns,Marguerite E %A Mundt,Marlon P %A Westergaard,Ryan P %+ Columbia University School of Social Work, 1255 Amsterdam Ave, New York, NY, 10027, United States, 1 2128512300, krh2151@columbia.edu %K hepatitis C virus %K intravenous drug abuse %K drug overdose %K harm reduction %K web-based intervention %D 2020 %7 29.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Syringe service programs (SSPs) are safe, highly effective programs for promoting health among people who inject drugs. However, resource limitations prevent the delivery of a full package of prevention services to many clients in need. Computer-tailored interventions may represent a promising approach for providing prevention information to people who inject drugs in resource-constrained settings. Objective: The aim of this paper is to assess the effect of a computer-tailored behavioral intervention, called Hep-Net, on safe injection practices, substance use reduction, overdose prevention, and hepatitis C virus (HCV) testing among SSP clients. Methods: Using a social network–based recruitment strategy, we recruited clients of an established SSP in Wisconsin and peers from their social networks. Participants completed a computerized baseline survey and were then randomly assigned to receive the Hep-Net intervention. Components of the intervention included an overall risk synthesis, participants’ selection of a behavioral goal, and an individualized risk reduction exercise. Individuals were followed up 3 months later to assess their behavior change. The effect of Hep-Net on receiving an HCV screening test, undergoing Narcan training, reducing the frequency of drug use, and sharing drug equipment was assessed. The individual’s readiness to change each behavior was also examined. Results: From 2014 to 2015, a total of 235 people who injected drugs enrolled into the Hep-Net study. Of these, 64.3% (151/235) completed the follow-up survey 3-6 months postenrollment. Compared with the control group, individuals who received the Hep-Net intervention were more likely to undergo HCV testing (odds ratio [OR] 2.23, 95% CI 1.05-4.74; P=.04) and receive Narcan training (OR 2.25, 95% CI 0.83-6.06; P=.11), and they shared drug equipment less frequently (OR 0.06, 95% CI 0.55-0.65; P<.001). Similarly, individuals who received the intervention were more likely to advance in their stage of readiness to change these 3 behaviors. However, intervention participants did not appear to reduce the frequency of drug use or increase their readiness to reduce drug use more than control participants, despite the fact that the majority of the intervention participants selected this as the primary goal to focus on after participation in the baseline survey. Conclusions: Implementing computer-based risk reduction interventions in SSPs may reduce harms associated with the sharing of injection equipment and prevent overdose deaths; however, brief computerized interventions may not be robust enough to overcome the challenges associated with reducing and ceasing drug use when implemented in settings centered on the delivery of prevention services. Trial Registration: ClinicalTrials.gov NCT02474043; https://clinicaltrials.gov/ct2/show/NCT02474043 International Registered Report Identifier (IRRID): RR2-10.2196/resprot.4830 %M 32990630 %R 10.2196/19703 %U http://www.jmir.org/2020/9/e19703/ %U https://doi.org/10.2196/19703 %U http://www.ncbi.nlm.nih.gov/pubmed/32990630 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e21749 %T Behavior Change Text Messages for Home Exercise Adherence in Knee Osteoarthritis: Randomized Trial %A Bennell,Kim %A Nelligan,Rachel K %A Schwartz,Sarah %A Kasza,Jessica %A Kimp,Alexander %A Crofts,Samuel JC %A Hinman,Rana S %+ Department of Physiotherapy, University of Melbourne, Centre for Health, Exercise and Sports Medicine, Level 7, Alan Gilbert Building, 161 Barry St, Carlton, 3053, Australia, 61 383444135, k.bennell@unimelb.edu.au %K knee osteoarthritis %K exercise %K patient compliance %K mobile phone %K randomized controlled trial %D 2020 %7 28.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Exercise is a core recommended treatment for knee osteoarthritis (OA), yet adherence declines, particularly following cessation of clinician supervision. Objective: This study aims to evaluate whether a 24-week SMS intervention improves adherence to unsupervised home exercise in people with knee OA and obesity compared with no SMS. Methods: A two-group superiority randomized controlled trial was performed in a community setting. Participants were people aged 50 years with knee OA and BMI ≥30 kg/m2 who had undertaken a 12-week physiotherapist-supervised exercise program as part of a preceding clinical trial. Both groups were asked to continue their home exercise program unsupervised three times per week for 24 weeks and were randomly allocated to a behavior change theory–informed, automated, semi-interactive SMS intervention addressing exercise barriers and facilitators or to control (no SMS). Primary outcomes were self-reported home exercise adherence at 24 weeks measured by the Exercise Adherence Rating Scale (EARS) Section B (0-24, higher number indicating greater adherence) and the number of days exercised in the past week (0-3). Secondary outcomes included self-rated adherence (numeric rating scale), knee pain, physical function, quality of life, global change, physical activity, self-efficacy, pain catastrophizing, and kinesiophobia. Results: A total of 110 participants (56 SMS group and 54 no SMS) were enrolled and 99 (90.0%) completed both primary outcomes (48/56, 86% SMS group and 51/54, 94% no SMS). At 24 weeks, the SMS group reported higher EARS scores (mean 16.5, SD 6.5 vs mean 13.3, SD 7.0; mean difference 3.1, 95% CI 0.8-5.5; P=.01) and more days exercised in the past week (mean 1.8, SD 1.2 vs mean 1.3, SD 1.2; mean difference 0.6, 95% CI 0.2-1.0; P=.01) than the control group. There was no evidence of between-group differences in secondary outcomes. Conclusions: An SMS program increased self-reported adherence to unsupervised home exercise in people with knee OA and obesity, although this did not translate into improved clinical outcomes. Trial Registration: Australian New Zealand Clinical Trials Registry 12617001243303; https://tinyurl.com/y2ud7on5 International Registered Report Identifier (IRRID): RR2-10.1186/s12891-019-2801-z %M 32985994 %R 10.2196/21749 %U http://www.jmir.org/2020/9/e21749/ %U https://doi.org/10.2196/21749 %U http://www.ncbi.nlm.nih.gov/pubmed/32985994 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e18233 %T Effectiveness of Human Versus Computer-Based Instructions for Exercise on Physical Activity–Related Health Competence in Patients with Hip Osteoarthritis: Randomized Noninferiority Crossover Trial %A Durst,Jennifer %A Roesel,Inka %A Sudeck,Gorden %A Sassenberg,Kai %A Krauss,Inga %+ Department of Sports Medicine, University Hospital, University of Tuebingen, Hoppe-Seyler-Str. 6, Tuebingen, 72076, Germany, 49 7071 2986486, inga.krauss@med.uni-tuebingen.de %K digital app %K exercise %K movement control %K self-efficacy %K control competence %K mHealth %K osteoarthritis %K tablet %D 2020 %7 28.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Hip and knee osteoarthritis is ranked as the 11th highest contributor to global disability. Exercise is a core treatment in osteoarthritis. The model for physical activity–related health competence describes possibilities to empower patients to perform physical exercises in the best possible health-promoting manner while taking into account their own physical condition. Face-to-face supervision is the gold standard for exercise guidance. Objective: The aim of this study was to evaluate whether instruction and guidance via a digital app is not inferior to supervision by a physiotherapist with regard to movement quality, control competence for physical training, and exercise-specific self-efficacy. Methods: Patients with clinically diagnosed hip osteoarthritis were recruited via print advertisements, emails and flyers. The intervention consisted of two identical training sessions with one exercise for mobility, two for strength, and one for balance. One session was guided by a physiotherapist and the other was guided by a fully automated tablet computer-based app. Both interventions took place at a university hospital. Outcomes were assessor-rated movement quality, and self-reported questionnaires on exercise-specific self-efficacy and control competence for physical training. Participants were randomly assigned to one of two treatment sequences. One sequence started with the app in the first session followed by the physiotherapist in the second session after a minimum washout phase of 27 days (AP group) and the other sequence occurred in the reverse order (PA group). Noninferiority was defined as a between-treatment effect (gIG)<0.2 in favor of the physiotherapist-guided training, including the upper confidence interval. Participants, assessors, and the statistician were neither blinded to the treatment nor to the treatment sequence. Results: A total of 54 participants started the first training session (32 women, 22 men; mean age 62.4, SD 8.2 years). The treatment sequence groups were similar in size (PA: n=26; AP: n=28). Seven subjects did not attend the second training session (PA: n=3; AP: n=4). The app was found to be inferior to the physiotherapist in all outcomes considered, except for movement quality of the mobility exercise (gIG –0.13, 95% CI –0.41-0.16). In contrast to the two strengthening exercises in different positions (supine gIG 0.76, 95% CI 0.39-1.13; table gIG 1.19, 95% CI 0.84-1.55), movement quality of the balance exercise was close to noninferiority (gIG 0.15, 95% CI –0.17-0.48). Exercise-specific self-efficacy showed a strong effect in favor of the physiotherapist (gIG 0.84, 95% CI 0.46-1.22). In terms of control competence for physical training, the app was only slightly inferior to the physiotherapist (gIG 0.18, 95% CI –0.14-0.50). Conclusions: Despite its inferiority in almost all measures of interest, exercise-specific self-efficacy and control competence for physical training did improve in patients who used the digital app. Movement quality was acceptable for exercises that are easy to conduct and instruct. The digital app opens up possibilities as a supplementary tool to support patients in independent home training for less complex exercises; however, it cannot replace a physiotherapist. Trial Registration: German Clinical Trial Register: DRKS00015759; http://www.drks.de/DRKS00015759 %M 32985991 %R 10.2196/18233 %U http://www.jmir.org/2020/9/e18233/ %U https://doi.org/10.2196/18233 %U http://www.ncbi.nlm.nih.gov/pubmed/32985991 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e19431 %T An Internet-Based Intervention Augmented With a Diet and Physical Activity Consultation to Decrease the Risk of Dementia in At-Risk Adults in a Primary Care Setting: Pragmatic Randomized Controlled Trial %A Anstey,Kaarin J %A Cherbuin,Nicolas %A Kim,Sarang %A McMaster,Mitchell %A D'Este,Catherine %A Lautenschlager,Nicola %A Rebok,George %A McRae,Ian %A Torres,Susan J %A Cox,Kay L %A Pond,Constance Dimity %+ School of Psychology, University of New South Wales, Matthews Building, Kensington, Sydney, 2031, Australia, 61 412935746, k.anstey@unsw.edu.au %K risk reduction behavior %K dementia prevention & control %K primary prevention %K pragmatic clinical trial %K prevention %K primary care %D 2020 %7 24.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: There is a need to develop interventions to reduce the risk of dementia in the community by addressing lifestyle factors and chronic diseases over the adult life course. Objective: This study aims to evaluate a multidomain dementia risk reduction intervention, Body Brain Life in General Practice (BBL-GP), targeting at-risk adults in primary care. Methods: A pragmatic, parallel, three-arm randomized trial involving 125 adults aged 18 years or older (86/125, 68.8% female) with a BMI of ≥25 kg/m2 or a chronic health condition recruited from general practices was conducted. The arms included (1) BBL-GP, a web-based intervention augmented with an in-person diet and physical activity consultation; (2) a single clinician–led group, Lifestyle Modification Program (LMP); and (3) a web-based control. The primary outcome was the Australian National University Alzheimer Disease Risk Index Short Form (ANU-ADRI-SF). Results: Baseline assessments were conducted on 128 participants. A total of 125 participants were randomized to 3 groups (BBL-GP=42, LMP=41, and control=42). At immediate, week 18, week 36, and week 62 follow-ups, the completion rates were 43% (18/42), 57% (24/42), 48% (20/42), and 48% (20/42), respectively, for the BBL-GP group; 71% (29/41), 68% (28/41), 68% (28/41), and 51% (21/41), respectively, for the LMP group; and 62% (26/42), 69% (29/42), 60% (25/42), and 60% (25/42), respectively, for the control group. The primary outcome of the ANU-ADRI-SF score was lower for the BBL-GP group than the control group at all follow-ups. These comparisons were all significant at the 5% level for estimates adjusted for baseline differences (immediate: difference in means −3.86, 95% CI −6.81 to −0.90, P=.01; week 18: difference in means −4.05, 95% CI −6.81 to −1.28, P<.001; week 36: difference in means −4.99, 95% CI −8.04 to −1.94, P<.001; and week 62: difference in means −4.62, 95% CI −7.62 to −1.62, P<.001). Conclusions: A web-based multidomain dementia risk reduction program augmented with allied health consultations administered within the general practice context can reduce dementia risk exposure for at least 15 months. This study was limited by a small sample size, and replication on a larger sample with longer follow-up will strengthen the results. Trial Registration: Australian clinical trials registration number (ACTRN): 12616000868482; https://anzctr.org.au/ACTRN12616000868482.aspx. %M 32969833 %R 10.2196/19431 %U http://www.jmir.org/2020/9/e19431/ %U https://doi.org/10.2196/19431 %U http://www.ncbi.nlm.nih.gov/pubmed/32969833 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 9 %P e18259 %T Guided Self-Help Behavioral Activation Intervention for Geriatric Depression: Protocol for Pilot Randomized Controlled Trial %A Wang,Xiaoxia %A Zhou,Xiaoyan %A Yang,Hui %+ Department of Basic Psychology, College of Psychology, Army Medical University, 30 # Gaotanyan Main Street, Shapingba District, Chongqing, 400038, China, 86 023 68771770, lemonowang@gmail.com %K psychiatry %K clinical %K psychology %K geriatric depression %K guided self-help %K behavior activation %K behavior inhibition %K behavior treatment %D 2020 %7 24.9.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Aging is a social concern. The increased incidence of depression in older populations in China poses a challenge to the health care system. Older adults who are depressed often suffer from a lack of motivation. Behavioral activation treatment, an evidence-based guided self-help treatment, is effective in reducing anhedonia and amotivation in depression; however, the efficacy of guided self-help behavioral activation in older adults with depression is not yet known. Objective: The aim of this study is to pilot a self-help guided intervention for the treatment of depression in older adults. Methods: This study has been designed as a pilot randomized controlled trial with inpatients (n=60; to be randomly allocated 1:1) between the ages of 60 and 70 and who have major depressive disorder. Patients attending clinical psychological clinics at the Mental Health Center of Chongqing will be randomized to either receive guided self-help behavioral activation (intervention) or to be on a 6-week waiting list (control). Participants in the treatment group will receive 6 sessions of guided self-help behavioral activation delivered over the telephone. The waiting list control group will receive the intervention after a period of 6 weeks. Exclusion criteria will be individuals who are at significant risk of harming themselves or others, who have a primary mental health disorder other than depression, or who have an intellectual disability that would hamper their ability to participate in the intervention. Effects of the treatment will be observed using outcomes in 3 domains: (1) clinical outcomes (symptom severity, recovery rate), (2) process variables (patient satisfaction, attendance, dropout), and (3) economic outcomes (cost and resource use). We will also examine mediators of outcomes in terms of patient variables (behavioral activation or inhibition motivation). We hypothesize that guided self-help behavioral activation will have a beneficial effect. Results: The study was approved by the research ethics committee of the Mental Health Center of Chongqing in November 2019. As of July 2020, recruitment had not yet begun. Data collection is expected to be completed by December 2020. Data analysis is expected to be completed by June 2021. Results will then be disseminated to patients, to the public, to clinicians, and to researchers through publications in journals and presentations at conferences. Conclusions: This will be the first study in China to investigate guided self-help interventions for patients who are older adults and who are depressed, a group which is currently underrepresented in mental health research. The intervention is modular and adapted from an empirically supported behavioral activation treatment for depression. The generalizability and broad inclusion criteria are strengths. Trial Registration: Chinese Clinical Trial Register ChiCTR1900026066; http://www.chictr.org.cn/showprojen.aspx?proj=43548 International Registered Report Identifier (IRRID): PRR1-10.2196/18259 %M 32518060 %R 10.2196/18259 %U https://www.researchprotocols.org/2020/9/e18259 %U https://doi.org/10.2196/18259 %U http://www.ncbi.nlm.nih.gov/pubmed/32518060 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e17906 %T Self-Practice of Stabilizing and Guided Imagery Techniques for Traumatized Refugees via Digital Audio Files: Qualitative Study %A Zehetmair,Catharina %A Nagy,Ede %A Leetz,Carla %A Cranz,Anna %A Kindermann,David %A Reddemann,Luise %A Nikendei,Christoph %+ Department of General Internal Medicine and Psychosomatics, Center for Psychosocial Medicine, University Hospital of Heidelberg, Thibautstraße 4, Heidelberg, 69115, Germany, 49 6221568373, Catharina.Zehetmair@med.uni-heidelberg.de %K stabilizing techniques %K guided imagery %K refugees %K qualitative analyses %K posttraumatic stress disorder %K mental health %K PTSD %K audio %K therapy %D 2020 %7 23.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Refugees have an increased risk of developing mental health problems. There are insufficient psychosocial care structures to meet the resulting need for support. Stabilizing and guided imagery techniques have shown promising results in increasing traumatized refugees’ emotional stabilization. If delivered via audio files, the techniques can be practiced autonomously and independent of time, space, and human resources or stable treatment settings. Objective: This study aimed to evaluate the self-practice of stabilizing and guided imagery techniques via digital audio files for traumatized refugees living in a reception and registration center in Germany. Methods: From May 2018 to February 2019, 42 traumatized refugees participated in our study. At T1, patients received digital audio files in English, French, Arabic, Farsi, Turkish, or Serbian for self-practice. Nine days later, at T2, a face-to-face interview was conducted. Two months after T2, a follow-up interview took place via telephone. Results: At T2, about half of the patients reported the daily practice of stabilizing and guided imagery techniques. At follow-up, the average frequency of practice was once weekly or more for those experiencing worse symptoms. No technical difficulties were reported. According to T2 and follow-up statements, the techniques helped the patients dealing with arousal, concentration, sleep, mood, thoughts, empowerment, and tension. The guided imagery technique “The Inner Safe Place” was the most popular. Self-practice was impeded by postmigratory distress factors, like overcrowded accommodations. Conclusions: The results show that self-practice of stabilizing and guided imagery techniques via digital audio files was helpful to and well accepted by the assessed refugees. Even though postmigratory distress factors hampered self-practice, “The Inner Safe Place” technique was particularly well received. Overall, the self-practiced audio-based stabilizing and guided imagery techniques showed promising results among the highly vulnerable group of newly arrived traumatized refugees. %M 32965229 %R 10.2196/17906 %U http://www.jmir.org/2020/9/e17906/ %U https://doi.org/10.2196/17906 %U http://www.ncbi.nlm.nih.gov/pubmed/32965229 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e17880 %T Exploring Participants’ Experiences of a Web-Based Program for Bulimia and Binge Eating Disorder: Qualitative Study %A Yim,See Heng %A Bailey,Emma %A Gordon,Gemma %A Grant,Nina %A Musiat,Peter %A Schmidt,Ulrike %+ King's College London, Institute of Psychiatry, Psychology and Neuroscience , PO Box 59, 16 De Crespigny Park, London, SE5 8AF, United Kingdom, 44 2078480160, see.yim@hmc.ox.ac.uk %K eHealth %K self-help %K eating disorders %K bulimia %K binge eating disorder %K internet-based intervention %K qualitative research %D 2020 %7 23.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Guided cognitive behavioral self-help is a recommended first-line treatment for eating disorders (EDs) such as bulimia nervosa (BN) or binge eating disorder (BED). Online versions of such self-help programs are increasingly being studied in randomized controlled trials (RCTs), with some evidence that they can reduce ED symptoms, although intervention dropout is variable across interventions. However, in-depth research into participants’ experiences and views on the acceptability of web-based interventions is limited. Objective: This is a qualitative process study of participants’ experiences of everyBody Plus, a web-based cognitive behavioral intervention, integrated into a large RCT to aid the interpretation of the main trial’s results. To our knowledge, this is the first such study in digital intervention for EDs research to include real-time feedback into the qualitative analysis. This study aims to build upon the emerging literature by qualitatively exploring participants’ experiences of a web-based intervention for BN and BED. Methods: Participants were those who took part in the UK arm of a larger RCT investigating the efficacy of the everyBody Plus intervention. Reflexive thematic analysis was completed on 2 sources of data from the online platform: real-time feedback quotes provided at the end of completing a module on the platform (N=104) and semistructured telephone interview transcripts (n=12). Results: Four main themes were identified. The first theme identified positive and negative user experiences, with a desire for a more customized and personalized intervention. Another theme positively reflected on how flexible and easy the intervention was to embed into daily life, compared with the silo of face-to-face therapy. The third theme identified how the intervention had a holistic impact cognitively, emotionally, interpersonally, and behaviorally. The final theme was related to how the intervention was not a one size fits all and how the perceived usefulness and relevance were often dependent on participants’ demographic and clinical characteristics. Conclusions: Overall, participants reported positive experiences with the use of the everyBody Plus web-based intervention, including flexibility of use and the potential to holistically impact people’s lives. The participants also provided valuable suggestions for how similar future web-based interventions could be improved and, in the context of EDs, how programs can be designed to be more inclusive of people by encompassing different demographic and clinical characteristics. %M 32965235 %R 10.2196/17880 %U http://www.jmir.org/2020/9/e17880/ %U https://doi.org/10.2196/17880 %U http://www.ncbi.nlm.nih.gov/pubmed/32965235 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e18519 %T Understanding the Steps Toward Mobile Early Intervention for Mothers and Their Infants Exiting the Neonatal Intensive Care Unit: Descriptive Examination %A Baggett,Kathleen M %A Davis,Betsy %A Landry,Susan H %A Feil,Edward G %A Whaley,Anna %A Schnitz,Alana %A Leve,Craig %+ Mark Chaffin Center for Healthy Development, School of Public Health, Georgia State Universtiy, 14th Marietta Street NW, Suite 100&200, GA 30303, Atlanta, GA, 30303, United States, 1 4044131571, kbaggett@gsu.edu %K early intervention %K equity %K NICU %K low birthweight %K transition %K mobile internet intervention %K infants %K mothers %D 2020 %7 22.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Neonatal intensive care unit (NICU) history, combined with systemic inequities for mothers of nondominant cultures and mothers who are socioeconomically disadvantaged, places infants at an extraordinary risk for poor developmental outcomes throughout life. Although receipt of early intervention (EI) is the best single predictor of developmental outcomes among children with and at risk for early developmental delays, mothers and infants with the greatest needs are least likely to receive EI. Mobile internet-based interventions afford substantial advantages for overcoming logistical challenges that often prevent mothers who are economically disadvantaged from accessing EI. However, the bridge from the NICU to a mobile internet intervention has been virtually unexplored. Objective: This study aims to examine progression flow from NICU exit referral to an early mobile internet intervention to increase EI access and promote parent mediation of infant social-emotional and communication development. Methods: Three NICUs serving the urban poor in a Midwestern city were provided support in establishing an electronic NICU exit referral mechanism into a randomized controlled trial of a mobile internet intervention for mothers and their infants. Measurement domains to reflect the bridge to service included each crucial gateway required for navigating the path into Part C EI, including referral, screening, assessment, and intervention access. An iterative process was used and documented to facilitate each NICU in establishing an individualized accountability plan for sharing referral materials with mothers before their NICU exit. Subsequent to the referral, progression flow was documented on the basis of a real-time electronic recording of service receipt and contact records. Mother and infant risk characteristics were also assessed. Descriptive analyses were conducted to summarize and characterize each measurement domain. Results: NICU referral rates for EI were 3 to 4 times higher for open-shared versus closed-single gatekeeper referral processes. Of 86 referred dyads, 67 (78%) were screened, and of those screened, 51 (76%) were eligible for assessment. Of the 51 assessment-eligible mothers and infants, 35 dyads (69%) completed the assessment and 31 (89%) went on to complete at least one remote coaching intervention session. The dyads who accessed and engaged in intervention were racially and ethnically diverse and experiencing substantial adversity. Conclusions: The transition from the NICU to home was fraught with missed opportunities for an EI referral. Beyond the referral, the most prominent reason for not participating in screening was that mothers could not be located after exiting the NICU. Stronger NICU referral mechanisms for EI are needed. It may be essential to initiate mobile interventions before exiting the NICU for maintaining post-NICU contact with some mothers. In contrast to a closed, single point of referral gatekeeper systems in NICUs, open, shared referral gating systems may be less stymied by individual service provider biases and disruptions. %M 32960178 %R 10.2196/18519 %U http://www.jmir.org/2020/9/e18519/ %U https://doi.org/10.2196/18519 %U http://www.ncbi.nlm.nih.gov/pubmed/32960178 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e17927 %T Effectiveness of a Web-Based SUpport PRogram (SUPR) for Hearing Aid Users Aged 50+: Two-Arm, Cluster Randomized Controlled Trial %A Meijerink,Janine FJ %A Pronk,Marieke %A Lissenberg-Witte,Birgit I %A Jansen,Vera %A Kramer,Sophia E %+ Otolaryngology—Head and Neck Surgery, Ear and Hearing, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, Amsterdam, Netherlands, 1 +31 020 444 905, m.pronk@amsterdamumc.nl %K hearing loss %K hearing aids %K auditory rehabilitation %K self-management %K communication programs %K internet %K hearing aid dispensing practice %K randomized controlled trial %D 2020 %7 22.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Hearing aid (HA) use is known to improve health outcomes for people with hearing loss. Despite that, HA use is suboptimal, and communication issues and hearing-related activity limitations and participation restrictions often remain. Web-based self-management communication programs may support people with hearing loss to effectively self-manage the impact of hearing loss in their daily lives. Objective: The goal of the research is to examine the short- and long-term effects of a web-based self-management SUpport PRogram (SUPR) on communication strategy use (primary outcome) and a range of secondary outcomes for HA users aged 50 years and older. Methods: Clients of 36 HA dispensing practices were randomized to SUPR (SUPR recipients; n=180 HA users) and 34 to care as usual (controls; n=163 HA users). SUPR recipients received a practical support booklet and online materials delivered via email over the course of their 6-month HA rehabilitation trajectory. They were encouraged to appoint a communication partner and were offered optional email contact with the HA dispensing practice. The online materials included 3 instruction videos on HA handling, 5 videos on communication strategies, and 3 testimonial videos. Care as usual included a HA fitting rehabilitation trajectory only. Measurements were carried out at baseline, immediately postintervention, 6 months postintervention, and 12 months postintervention. The primary outcome measure was self-reported use of communication strategies (3 subscales of the Communication Profile for the Hearing Impaired [CPHI]). Secondary outcome measures included self-reported personal adjustment to hearing loss (CPHI); use, satisfaction and benefit of HAs and SUPR (use questionnaire; International Outcome Inventory for Hearing Aids [IOI-HA], Alternative Interventions [IOI-AI]); recommendation of HA dispensing services; self-efficacy for HA handling (Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids [MARS-HA]); readiness to act on hearing loss (University of Rhode Island Change Assessment adapted for hearing loss [URICA-HL]); and hearing disability (Amsterdam Inventory for Auditory Disability and Handicap [AIADH]). Results: Linear mixed model analyses (intention to treat) showed no significant differences between the SUPR and control group in the course of communication strategy use (CPHI). Immediately postintervention, SUPR recipients showed significantly higher self-efficacy for advanced HA handling than the controls, which was sustained at 12 months (MARS-HA; mean difference immediately postintervention: 5.3, 95% CI 0.3 to 10.4; P=.04). Also, SUPR recipients showed significantly greater HA satisfaction than controls immediately postintervention (IOI-HA; 0.3, 95% CI 0.09 to 0.5; P=.006), which was sustained at 12 months, and significantly greater HA use than the controls immediately postintervention (IOI-HA; 0.3, 95% CI 0.02 to 0.5; P=.03), which was not sustained at 12 months. Conclusions: This study provides ground to recommend adding SUPR to standard HA dispensing care, as long-term, modest improvements in HA outcomes were observed. Further research is needed to evaluate what adjustments to SUPR are needed to establish long-term effectiveness on outcomes in the psychosocial domain. Trial Registration: ISRCTN77340339; http://www.isrctn.com/ISRCTN77340339 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2016-015012 %M 32960175 %R 10.2196/17927 %U http://www.jmir.org/2020/9/e17927/ %U https://doi.org/10.2196/17927 %U http://www.ncbi.nlm.nih.gov/pubmed/32960175 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e15307 %T Identifying Mobile Health Engagement Stages: Interviews and Observations for Developing Brief Message Content %A Burns,Kara %A Nicholas,Rebekah %A Beatson,Amanda %A Chamorro-Koc,Marianella %A Blackler,Alethea %A Gottlieb,Udo %+ School of Advertising, Marketing and Public Relations, QUT Business School, Queensland University of Technology, George St, Brisbane, QLD, 4000, Australia, 61 414294967, drkaraburns@gmail.com %K mobile health %K text messaging %K social media %K mobile phone %K health communication %D 2020 %7 22.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Interest in mobile health (mHealth) has increased recently, and research suggests that mHealth devices can enhance end-user engagement, especially when used in conjunction with brief message content. Objective: This research aims to explore the stages of engagement framework for mHealth devices and develop a method to generate brief message content to promote sustained user engagement. This study uses the framework by O’Brien and Toms as a point of departure, where engagement is defined as the uptake or the use of an mHealth device. The framework is a linear repeatable process, including point of engagement, period of engagement, disengagement, and re-engagement. Each stage is characterized by attributes related to a person’s technology experience. Although the literature has identified stages of engagement for health-related technology, few studies explore mHealth engagement. Furthermore, little research has determined a method for creating brief message content at each stage in this engagement journey. Methods: Interviews and observations from 19 participants who used mHealth technologies (apps, devices, or wellness websites) in a solo capacity were recruited for sample group 1. In sample group 2, interviews, and observations from 25 participants using mHealth technologies in a group capacity through the Global Corporate Challenge were used. These samples were investigated at 3 time points in both research contexts. The results underwent deductive-inductive thematic analysis for the engagement stages’ framework and attributes. Results: In addition to the 4 stages identified by O’Brien and Toms, 2 additional stages, self-management and limited engagement, were identified. Self-management captures where users had disengaged from their technology but were still engaged with their health activity. Limited engagement captures where group mHealth users had minimal interaction with their mHealth technology but continued to engage in a group fitness activity. The results revealed that mHealth engagement stages were nonlinear and embedded in a wider engagement context and that each stage was characterized by a combination of 49 attributes that could be organized into 8 themes. Themes documented the total user experience and included technology usability, technology features, technology aesthetics, use motivations, health awareness, goal setting, social support, and interruptions. Different themes were found to have more relevance at different engagement stages. Knowing themes and attributes at all engagement stages allows technology developers and health care professionals to generate relevant brief message content informed by a person-centered approach. Conclusions: This research extends an existing engagement stages framework and identifies attributes and themes relevant to mHealth technology users’ total user experience and incorporates concepts derived from health, business studies, and information systems literature. In addition, we offer a practical 5-step process based on a person-centered approach to develop mHealth technology brief message content for sustained engagement. %M 32960181 %R 10.2196/15307 %U http://www.jmir.org/2020/9/e15307/ %U https://doi.org/10.2196/15307 %U http://www.ncbi.nlm.nih.gov/pubmed/32960181 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e19066 %T Designing a Web-Based Psychological Intervention for Patients With Myocardial Infarction With Nonobstructive Coronary Arteries: User-Centered Design Approach %A Humphries,Sophia Monica %A Rondung,Elisabet %A Norlund,Fredrika %A Sundin,Örjan %A Tornvall,Per %A Held,Claes %A Spaak,Jonas %A Lyngå,Patrik %A Olsson,Erik M G %+ Department of Women's and Children's Health, Uppsala University, Akademiska Hospital, Uppsala, 75185, Sweden, 46 760341186, sophia.humphries@kbh.uu.se %K web-based intervention %K iCBT %K myocardial infarction %K nonobstructive coronary arteries %K patient involvement %K psychological treatment %K MINOCA %K takotsubo cardiomyopathy %D 2020 %7 17.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: The involvement of patient research partners (PRPs) in research aims to safeguard the needs of patient groups and produce new interventions that are developed based on patient input. Myocardial infarction with nonobstructive coronary arteries (MINOCA), unlike acute myocardial infarction (MI) with obstructive coronary arteries, is presented with no significant obstructive coronary artery disease. Patients with this diagnosis are a subset of those diagnosed with traditional MI and often need more psychological support, something that is presently not established in the current treatment scheme in Swedish health care or elsewhere, to our knowledge. An internet-delivered intervention might offer patients with MINOCA the opportunity to access a psychological treatment that is tailored to their specific needs after MINOCA and could therefore supplement the existing medical care in an easily accessible format. Objective: This paper aims to describe the development of a therapist-guided, internet-delivered psychological intervention designed specifically for patients with MINOCA. Methods: The study used a participatory design that involved 7 PRPs diagnosed with MINOCA who collaborated with a team consisting of researchers, cardiologists, and psychologists. Intervention content was developed iteratively and presented to the PRPs across several prototypes, each continually adjusted and redesigned according to the feedback received. The intervention and experience of it were discussed by PRPs in a final meeting and then presented to a panel of 2 clinical psychologists and a cardiologist for further input. Results: The outcome of the collaboration between PRPs and the research group produced a web-based psychological 9-step program focusing on stress, worry, and valued action. The input from PRPs contributed substantially to the therapy content, homework tasks, interactive activities, multimedia, and design presentation. Conclusions: Working with PRPs to develop an intervention for people with MINOCA produced a web-based intervention that can be further evaluated with the goal of offering a new psychological treatment option to a patient group currently without one. Direct contribution from PRPs enabled us to obtain relevant, insightful, and valuable feedback that was put towards the overall design and content of the intervention. %M 32940615 %R 10.2196/19066 %U http://www.jmir.org/2020/9/e19066/ %U https://doi.org/10.2196/19066 %U http://www.ncbi.nlm.nih.gov/pubmed/32940615 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e18037 %T Sun Safe Partners Online: Pilot Randomized Controlled Clinical Trial %A Manne,Sharon %A Buller,David %A Devine,Katie %A Heckman,Carolyn %A Pagoto,Sherry %A Frederick,Sara %A Mitarotondo,Anna %+ Rutgers Cancer Institute of New Jersey, CINJ, 195 Little Albany Street, New Brunswick, NJ, 08903, United States, 1 732 235 9780, mannesl@cinj.rutgers.edu %K sun protection %K behavior intervention %K online interventions %K couples %K skin cancer prevention %K mobile phone %D 2020 %7 17.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Harnessing supportive influences in close relationships is an innovative and potentially effective strategy to improve sun protection behaviors. Objective: This pilot randomized controlled clinical trial evaluates the feasibility and impact of Sun Safe Partners Online, a web-based, couples-focused intervention to improve sun protection behavior. Methods: A total of 75 couples reporting suboptimal levels of sun protection recruited from Facebook advertisements were randomized to receive a web-based intervention called Sun Safe Partners Online or a Generic Online Sun Safety Information intervention. Sun Safe Partners Online had 4 individual-focused modules and 4 couples-focused modules. Feasibility was assessed by study enrollment, engagement, follow-up survey completion, and intervention evaluation. Participants completed baseline and a 1-month postintervention survey assessing sun protection and exposure, along with individual and relationship attitudes about the importance of sun protection. Results: Using Facebook as a recruitment strategy resulted in rapid enrollment and higher acceptance than for the prior telephone and print trial. The follow-up survey completion was higher in the Generic Online condition (100%) than in the Sun Safe Partners Online condition (87.2%). Engagement in Sun Safe Partners Online was high, with more than two-thirds of participants completing all modules. Evaluations of Sun Safe Partners Online content and features as well as ease of navigation were excellent. Sun Safe Partners Online showed small effects on sun protection behaviors and sun exposure on weekends compared with the Generic Online intervention and moderate effect size increases in the Sun Safe Partners Online condition. Conclusions: This study uses a novel approach to facilitate engagement in sun protection by harnessing the influence of relationships among spouses and cohabiting partners. A couples-focused intervention may hold promise as a means to improve sun protection behaviors beyond interventions focused solely on individuals by leveraging the concern, collaboration, and support among intimate partners and addressing relationship-based barriers to sun protection. Trial Registration: ClinicalTrials.gov NCT04549675; https://clinicaltrials.gov/ct2/show/NCT04549675 %M 32673215 %R 10.2196/18037 %U https://www.jmir.org/2020/9/e18037 %U https://doi.org/10.2196/18037 %U http://www.ncbi.nlm.nih.gov/pubmed/32673215 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e16450 %T User Experience and Effects of an Individually Tailored Transdiagnostic Internet-Based and Mobile-Supported Intervention for Anxiety Disorders: Mixed-Methods Study %A Weisel,Kiona K %A Zarski,Anna-Carlotta %A Berger,Thomas %A Krieger,Tobias %A Moser,Christian T %A Schaub,Michael P %A Görlich,Dennis %A Berking,Matthias %A Ebert,David D %+ Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Nägelsbachstraße 25a, Erlangen, Germany, 49 (0)9131 ext 8567570, kiona.weisel@fau.de %K transdiagnostic %K anxiety %K depression %K tailored %K internet intervention %D 2020 %7 16.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet interventions have been shown to be effective in treating anxiety disorders. Most interventions to date focus on single disorders and disregard potential comorbidities. Objective: The aim of this mixed-methods study was to investigate feasibility, user experience, and effects of a newly developed individually tailored transdiagnostic guided internet intervention for anxiety disorders. Methods: This study is an uncontrolled, within-group, baseline, postintervention pilot trial with an embedded qualitative and quantitative process and effect evaluation. In total, 49 adults with anxiety disorders (generalized anxiety disorder n=20, social phobia n=19, agoraphobia without panic n=12, panic with agoraphobia n=6, panic without agoraphobia n=4, subclinical depression n=41) received access to the 7-session intervention. We examined motivation and expectations, intervention use, user experience, impact, and modification requests. Qualitative data were assessed using semistructured interviews and analyzed by qualitative content analysis. Quantitative outcomes included symptom severity of anxiety and depression (Hamilton Anxiety Rating Scale [HAM-A], Quick Item Inventory of Depressive Symptomatology clinician rating [QIDS-C]), diagnostic status in clinical interviews (Mini International Neuropsychiatric Interview [MINI]), and web-based self-reports (Generalized Anxiety Disorder–7 [GAD-7], Center for Epidemiological Studies Depression Scale [CES-D], Beck Anxiety Inventory [BAI], Panic and Agoraphobia Scale [PAS], Social Phobia Scale [SPS], Patient Health Questionnaire–9 [PHQ-9]) at baseline and postassessment. Quantitative data was analyzed by comparing within-group means expressed as Cohen d. Results: Anxiety symptom severity (HAM-A d=1.19) and depressive symptoms (QIDS-C d=0.42) improved significantly, and 54% (21/39) no longer were diagnosed as having any anxiety disorder. The main positive effects were the general improvement of disease burden and attentiveness to feelings and risk situations while the main negative effects experienced were lack of change in disease burden and symptom deterioration. The most prevalent reasons for participation were the advantages of online treatment, symptom burden, and openness toward online treatment. Helpful factors included support, psychoeducation and practicing strategies in daily life; the main hindering factors were too little individualization and being overwhelmed by the content and pace. Conclusions: The intervention was found to be feasible and results show preliminary data indicating potential efficacy for improving anxiety and depression. The next step should be the evaluation within a randomized controlled trial. Concerning intervention development, it was found that future interventions should emphasize individualization even more in order to further improve the fit to individual characteristics, preferences, and needs. %M 32936085 %R 10.2196/16450 %U http://www.jmir.org/2020/9/e16450/ %U https://doi.org/10.2196/16450 %U http://www.ncbi.nlm.nih.gov/pubmed/32936085 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 9 %P e15625 %T Role of a Digital Return-To-Work Solution for Individuals With Common Mental Disorders: Qualitative Study of the Perspectives of Three Stakeholder Groups %A Engdahl,Patrik %A Svedberg,Petra %A Lexén,Annika %A Bejerholm,Ulrika %+ Mental Health, Activity and Participation, Department of Health Science, Lund University, PO Box 157, Lund, SE-22100, Sweden, 46 462221958, patrik.engdahl@med.lu.se %K qualitative method %K mental health %K mHealth %K quality improvement %K vocational rehabilitation %D 2020 %7 16.9.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: Although effective return-to-work (RTW) interventions are not widely available for individuals with common mental disorders on sick leave, there is potential for transforming such interventions into a digital solution in an effort to make them more widely available. However, little is currently known about the viewpoints of different stakeholder groups, which are critical for successful development and implementation of a digital RTW intervention in health care services. Objective: The aim of this study was to examine stakeholder groups’ perspectives on the role and legitimacy of a digital RTW solution called mWorks for individuals with common mental disorders who are on sick leave. Methods: A purposeful snowball sampling method was utilized to recruit respondents. Semistructured individual and focus group interviews were conducted for stakeholder groups of service users, RTW professionals, and influential managers regarding their experiences, needs, and preferences for mWorks. Content analysis generated themes and categories that constituted the main findings. Results: The legitimacy of a digital RTW solution was high among all stakeholder groups since such a tool was perceived to enable service users to take control over their RTW process. This was mainly a product of accessible support and promotion of service user decision making, which had the potential to empower service users. All respondents stressed the importance of fostering a positive user experience with usability and emphasis on service user resources and strengths, as opposed to various limitations and shortcomings. Stakeholder groups highlighted critical content to facilitate RTW, such as the need to clarify a back-to-work plan, accompanied by an accessible RTW network and strategies for handling mental health problems. Implementation challenges primarily involved influential managers’ concern of legislation incompatibility with innovative technology, and RTW professionals’ concern of the possibility that digital solutions may replace them to a certain extent. Conclusions: This formative research emphasizes the importance of shifting power from RTW professionals to service users. mWorks can play a role in mediating service user control over the RTW process, and thereby increase their empowerment. A digital RTW solution may facilitate the circumvention of implementation barriers associated with introducing evidence-based RTW interventions in a traditional RTW context. %M 32936089 %R 10.2196/15625 %U http://formative.jmir.org/2020/9/e15625/ %U https://doi.org/10.2196/15625 %U http://www.ncbi.nlm.nih.gov/pubmed/32936089 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 9 %P e17269 %T Providing Unique Support for Health Study Among Young Black and Latinx Men Who Have Sex With Men and Young Black and Latinx Transgender Women Living in 3 Urban Cities in the United States: Protocol for a Coach-Based Mobile-Enhanced Randomized Control Trial %A Arrington-Sanders,Renata %A Hailey-Fair,Kimberly %A Wirtz,Andrea %A Cos,Travis %A Galai,Noya %A Brooks,Durryle %A Castillo,Marne %A Dowshen,Nadia %A Trexler,Constance %A D’Angelo,Lawrence J %A Kwait,Jennafer %A Beyrer,Chris %A Morgan,Anthony %A Celentano,David %A , %+ Division of Adolescent and Young Adult Medicine, Johns Hopkins School of Medicine, 200 North Wolfe Street, Baltimore, MD, United States, 1 4105028166, rarring3@jhmi.edu %K African-American %K Latinx %K men and transgender %K HIV %K youth %K mobile phone %D 2020 %7 16.9.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: The US National HIV/AIDS Strategy 2020 calls for increasing access to care, improving outcomes of people living with HIV, and targeting biomedical prevention efforts, including access to pre-exposure prophylaxis (PrEP) in communities where HIV is most heavily concentrated. The cities of Baltimore, Maryland (MD); Washington, DC; and Philadelphia, Pennsylvania (PA) are disproportionately burdened by high rates of new cases of HIV infection, with high prevalence among young Black and Latinx men who have sex with men (YBLMSM) and young Black and Latinx transgender women (YBLTW) aged 15-24 years. Objective: This study aims (1) to identify and recruit YBLMSM and YBLTW who are at risk or living with HIV in Baltimore, MD; Philadelphia, PA; and Washington, DC, using respondent-driven sampling (RDS) with targeted seed selection, and (2) to assess the efficacy of a coach-based mobile-enhanced intervention (MEI) compared with standard of care (SOC) to increase successful engagement and retention into HIV, PrEP, and substance use treatment care across the HIV care and prevention continua in 3 Mid-Atlantic cities. This paper describes the protocol and progress as of October 20, 2019. Methods: This study uses a multiphase mixed methods design. The first phase is a formative, qualitative research with focus group discussions and key informant interviews. The second phase consists of evaluating the ability of RDS with targeted seed selection. The third phase includes 2 embedded randomized controlled trials (RCTs), where participants complete a baseline sociobehavioral survey, rapid HIV testing, and eligible youth enroll in parallel status-dependent RCTs that randomize the participant to 1 of 2 study arms: MEI with coach or SOC. Participants are asked to complete a web-based survey and provide biologic specimens—HIV-1 RNA (viral load) or HIV-1 antibody test and urine drug screen—at baseline and at 3, 6, and 12 months, and an exit interview at 18 months. Results: A formative qualitative research was conducted in February 2017 and May 2018, and this led to further refinement of recruitment and study methods. Aim 1 recruitment began in September 2017 with subsequent enrollment into the RCTs. Recruitment is ongoing with 520 participants screened and 402 (77.3%) enrolled in aim 1 by October 2020. Of these, 159 are enrolled in the 2 randomized trials: 36 (22.6%) HIV-positive not virally suppressed (aim 2) and 123 (77.4%) high-risk HIV-negative (aim 3). Conclusions: This study has the potential to significantly impact the medical and substance use services provided to YBLMSM and YBLTW in the United States by providing rigorous scientific evidence outlining approaches and strategies that improve the uptake and engagement of YBLMSM and YBLTW in the HIV treatment and prevention continuum. Trial Registration: ClinicalTrials.gov NCT03194477; https://clinicaltrials.gov/ct2/show/NCT03194477 International Registered Report Identifier (IRRID): DERR1-10.2196/17269 %M 32935662 %R 10.2196/17269 %U https://www.researchprotocols.org/2020/9/e17269 %U https://doi.org/10.2196/17269 %U http://www.ncbi.nlm.nih.gov/pubmed/32935662 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e20701 %T Artificial Intelligence-Based Conversational Agents for Chronic Conditions: Systematic Literature Review %A Schachner,Theresa %A Keller,Roman %A v Wangenheim,Florian %+ Department of Management, Technology, and Economics, ETH Zurich, WEV G 228, Weinbergstr 56/58, Zurich , Switzerland, 41 446325209, tschachner@ethz.ch %K artificial intelligence %K conversational agents %K chatbots %K healthcare %K chronic diseases %K systematic literature review %D 2020 %7 14.9.2020 %9 Review %J J Med Internet Res %G English %X Background: A rising number of conversational agents or chatbots are equipped with artificial intelligence (AI) architecture. They are increasingly prevalent in health care applications such as those providing education and support to patients with chronic diseases, one of the leading causes of death in the 21st century. AI-based chatbots enable more effective and frequent interactions with such patients. Objective: The goal of this systematic literature review is to review the characteristics, health care conditions, and AI architectures of AI-based conversational agents designed specifically for chronic diseases. Methods: We conducted a systematic literature review using PubMed MEDLINE, EMBASE, PyscInfo, CINAHL, ACM Digital Library, ScienceDirect, and Web of Science. We applied a predefined search strategy using the terms “conversational agent,” “healthcare,” “artificial intelligence,” and their synonyms. We updated the search results using Google alerts, and screened reference lists for other relevant articles. We included primary research studies that involved the prevention, treatment, or rehabilitation of chronic diseases, involved a conversational agent, and included any kind of AI architecture. Two independent reviewers conducted screening and data extraction, and Cohen kappa was used to measure interrater agreement.A narrative approach was applied for data synthesis. Results: The literature search found 2052 articles, out of which 10 papers met the inclusion criteria. The small number of identified studies together with the prevalence of quasi-experimental studies (n=7) and prevailing prototype nature of the chatbots (n=7) revealed the immaturity of the field. The reported chatbots addressed a broad variety of chronic diseases (n=6), showcasing a tendency to develop specialized conversational agents for individual chronic conditions. However, there lacks comparison of these chatbots within and between chronic diseases. In addition, the reported evaluation measures were not standardized, and the addressed health goals showed a large range. Together, these study characteristics complicated comparability and open room for future research. While natural language processing represented the most used AI technique (n=7) and the majority of conversational agents allowed for multimodal interaction (n=6), the identified studies demonstrated broad heterogeneity, lack of depth of reported AI techniques and systems, and inconsistent usage of taxonomy of the underlying AI software, further aggravating comparability and generalizability of study results. Conclusions: The literature on AI-based conversational agents for chronic conditions is scarce and mostly consists of quasi-experimental studies with chatbots in prototype stage that use natural language processing and allow for multimodal user interaction. Future research could profit from evidence-based evaluation of the AI-based conversational agents and comparison thereof within and between different chronic health conditions. Besides increased comparability, the quality of chatbots developed for specific chronic conditions and their subsequent impact on the target patients could be enhanced by more structured development and standardized evaluation processes. %M 32924957 %R 10.2196/20701 %U http://www.jmir.org/2020/9/e20701/ %U https://doi.org/10.2196/20701 %U http://www.ncbi.nlm.nih.gov/pubmed/32924957 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e19256 %T Digital Health Tools and Patients With Drug Use Disorders: Qualitative Patient Experience Study of the Electronic Case-Finding and Help Assessment Tool (eCHAT) %A Choy,Melinda Ada %A Sturgiss,Elizabeth %A Goodyear-Smith,Felicity %A Smith,Gavin JD %+ Academic Unit of General Practice, College of Health and Medicine, The Australian National University, Building 4, Level 2, The Canberra Hospital, Garran, 2605, Australia, 61 5124 5592, melinda.choy@anu.edu.au %K eCHAT %K eHealth %K mHealth %K digital health %K drug use disorders %K patient experience %K stigma %K patient experience %K family medicine %K general practice %D 2020 %7 14.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: One of the promises of digital health is to better engage patients and improve care for vulnerable populations. Patients with drug use disorders are a vulnerable population who often do not receive the care they need, both for their drug use disorders as well as their other health care needs. Appropriate primary care for patients with drug use disorders needs to be patient-centered, holistic, highly accessible, and engaging. The electronic Case-finding and Help Assessment Tool (eCHAT) was designed as a patient-centered tool for the identification and measurement of problematic health behaviors and mood states. Objective: The aim of this study was to explore the patient experience of eCHAT at an Australian family medicine clinic for patients with drug use disorders. Methods: A total of 12 semistructured interviews were conducted with patients, two interviews were conducted with doctors, and one focus group was conducted with patient advocates who were former patients of the clinic where the study took place. The transcripts were analyzed using inductive thematic analysis. Results: The key themes identified from the interviews and the focus group were as follows: (1) eCHAT helped reduce stigma related to drug use in the doctor-patient consultation, (2) restricted answer options impacted the ability of patients to tell their stories, (3) patient-related response factors, (4) increased efficiency in the consultation process, and (5) divergence in level of concern around security and privacy. Conclusions: eCHAT has the potential to help vulnerable patients in primary care to engage more with their doctors and reduce experiences of stigma. eCHAT may be a useful digital health intervention in a family medicine clinic for patients with drug use disorders. It has the potential to improve patient engagement and access to health care, which are crucial areas of need in this vulnerable population. However, it is important to clearly communicate the privacy risk of digital health tools and to implement eCHAT such that it will add value to, rather than displace, in-person consultations with the family doctor. %M 32924959 %R 10.2196/19256 %U http://www.jmir.org/2020/9/e19256/ %U https://doi.org/10.2196/19256 %U http://www.ncbi.nlm.nih.gov/pubmed/32924959 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e11543 %T Motivation Predicts Change in Nurses’ Physical Activity Levels During a Web-Based Worksite Intervention: Results From a Randomized Trial %A Brunet,Jennifer %A Tulloch,Heather E %A Wolfe Phillips,Emily %A Reid,Robert D %A Pipe,Andrew L %A Reed,Jennifer L %+ Faculty of Health Sciences, University of Ottawa, Montpetit Hall 339, 125 University Private, Ottawa, ON, K1N 6N5, Canada, 1 613 562 5800 ext 3068, jennifer.brunet@uottawa.ca %K physical activity %K motivation %K wearable technology %K nurses %D 2020 %7 11.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Low physical activity levels can negatively affect the health of nurses. Given the low physical activity levels reported by nurses, there is a clear need for brief and economical interventions designed to increase physical activity levels in this population. We developed a web-based intervention that used motivational strategies to increase nurses’ physical activity levels. The intervention provided the nurses with feedback from an activity monitor coupled with a web-based individual, friend, or team physical activity challenge. Objective: In this parallel-group randomized trial, we examine whether nurses’ motivation at baseline predicted changes in objectively measured physical activity levels during the 6-week intervention. Methods: The participants were 76 nurses (n=74, 97% female; mean age 46, SD 11 years) randomly assigned to 1 of 3 physical activity challenge conditions: (1) individual, (2) friend, or (3) team. The nurses completed a web-based questionnaire designed to assess motivational regulations for physical activity levels before the intervention and wore a Tractivity activity monitor before and during the 6-week intervention. We analyzed data using multilevel modeling for repeated measures. Results: The nurses’ physical activity levels increased (linear estimate=10.30, SE 3.15; P=.001), but the rate of change decreased over time (quadratic estimate=−2.06, SE 0.52; P<.001). External and identified regulations (ß=−2.08 to 11.55; P=.02 to .04), but not intrinsic and introjected regulations (ß=−.91 to 6.29; P=.06 to .36), predicted changes in the nurses’ physical activity levels. Conclusions: Our findings provide evidence that an intervention that incorporates self-monitoring and physical activity challenges can be generally effective in increasing nurses’ physical activity levels in the short term. They also suggest that drawing solely on organismic integration theory to predict changes in physical activity levels among the nurses participating in web-based worksite interventions may have been insufficient. Future research should examine additional personal (eg, self-efficacy) and occupational factors (eg, shift length and shift type) that influence physical activity levels to identify potential targets for intervention among nurses. Trial Registration: ClinicalTrials.gov NCT04524572; https://clinicaltrials.gov/ct2/show/NCT04524572 %M 32915158 %R 10.2196/11543 %U http://www.jmir.org/2020/9/e11543/ %U https://doi.org/10.2196/11543 %U http://www.ncbi.nlm.nih.gov/pubmed/32915158 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e18038 %T Factors Affecting the Implementation of Electronic Antiretroviral Therapy Adherence Monitoring and Associated Interventions for Routine HIV Care in Uganda: Qualitative Study %A Haberer,Jessica E %A Garrison,Lindsey %A Tumuhairwe,John Bosco %A Baijuka,Robert %A Tindimwebwa,Edna %A Tinkamanyire,James %A Burns,Bridget F %A Asiimwe,Stephen %+ Center for Global Health, Massachusetts General Hospital, 125 Nashua St, Suite 722, Boston, MA, United States, 1 617 724 0351, jhaberer@partners.org %K adherence %K antiretroviral therapy %K electronic monitoring %K implementation science %D 2020 %7 10.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: High, sustained adherence to HIV antiretroviral therapy (ART) is critical for achieving viral suppression, which in turn leads to important individual health benefits and reduced secondary viral transmission. Electronic adherence monitors record a date-and-time stamp with each opening as a proxy for pill-taking behavior. These monitors can be combined with interventions (eg, data-informed adherence counseling, SMS-based adherence support, and/or alarms) and have been shown to improve adherence in multiple settings. Their use, however, has largely been limited to the research context. Objective: The goal of the research was to use the Consolidated Framework for Implementation Research (CFIR) to understand factors relevant for implementing a low-cost electronic adherence monitor and associated interventions for routine HIV clinical care in Uganda. Methods: We conducted in-depth qualitative interviews with health care administrators, clinicians, and ART clients about likes and dislikes of the features and functions of electronic adherence monitors and associated interventions, their potential to influence HIV care, suggestions on how to measure their value, and recommendations for their use in routine care. We used an inductive, content analysis approach to understand participant perspectives, identifying aspects of CFIR most relevant to technology implementation in this setting. Results: We interviewed 34 health care administrators/clinicians and 15 ART clients. Participants largely saw the monitors and associated interventions as favorable and beneficial for supporting adherence and improving clinical outcomes through efficient, differentiated care. Relevant outside factors included structural determinants of health, international norms around supporting adherence, and limited funding that necessitates careful assessment of costs and benefits. Within the clinic, the adherence data were felt likely to improve the quality of counseling and thereby morale, as well as increase the efficiency of care delivery. Existing infrastructure and care expenditures and the need for proper training were other noted considerations. At the individual level, the desire for good health and a welcomed pressure to adhere favored uptake of the monitors, although some participants were concerned with clients not using the monitors as planned and the influence of poverty, stigma, and need for privacy. Finally, participants felt that decisions around the implementation process would have to come from the Ministry of Health and other funders and would be influenced by sustainability of the technology and the target population for its use. Coordination across the health care system would be important for implementation. Conclusions: Low-cost electronic adherence monitoring combined with data-informed counseling, SMS-based support, and/or alarms have potential for use in routine HIV care in Uganda. Key metrics of successful implementation will include their impact on efficiency of care delivery and clinical outcomes with careful attention paid to factors such as stigma and cost. Further theory-driven implementation science efforts will be needed to move promising technology from research into clinical care. Trial Registration: ClinicalTrials.gov NCT03825952; https://clinicaltrials.gov/ct2/show/NCT03825952 %M 32687473 %R 10.2196/18038 %U http://www.jmir.org/2020/9/e18038/ %U https://doi.org/10.2196/18038 %U http://www.ncbi.nlm.nih.gov/pubmed/32687473 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e19468 %T Internet-Based Supportive Interventions for Family Caregivers of People With Dementia: Systematic Review and Meta-Analysis %A Leng,Minmin %A Zhao,Yajie %A Xiao,Hongmei %A Li,Ce %A Wang,Zhiwen %+ School of Nursing, Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China, 86 15901566817, wzwjing@sina.com %K family caregivers %K dementia %K supportive interventions %K internet %K systematic review %D 2020 %7 9.9.2020 %9 Review %J J Med Internet Res %G English %X Background: Caring for people with dementia is perceived as one of the most stressful and difficult forms of caring. Family caregivers always experience high levels of psychological burden and physical strain, so effective and practical support is essential. Internet-based supportive interventions can provide convenient and efficient support and education to potentially reduce the physical and psychological burden associated with providing care. Objective: This review aimed to (1) assess the efficacy of internet-based supportive interventions in ameliorating health outcomes for family caregivers of people with dementia, and (2) evaluate the potential effects of internet-based supportive intervention access by caregivers on their care recipients. Methods: An electronic literature search of the PubMed, EMBASE, Web of Science, CINAHL, Cochrane Library, and PsycINFO databases was conducted up to January 2020. Two reviewers (ML and YZ) worked independently to identify randomized controlled trials (RCTs) that met the inclusion criteria and independently extracted data. The quality of the included RCTs was evaluated using the approach recommended by the Cochrane Handbook for Systematic Reviews of Interventions. Standardized mean differences (SMDs) with 95% CIs were applied to calculate the pooled effect sizes. Results: In total, 17 RCTs met the eligibility criteria and were included in this systematic review. The meta-analysis showed that internet-based supportive interventions significantly ameliorated depressive symptoms (SMD=–0.21; 95% CI –0.31 to –0.10; P<.001), perceived stress (SMD=–0.40; 95% CI –0.55 to –0.24; P<.001), anxiety (SMD=–0.33; 95% CI –0.51 to –0.16; P<.001), and self-efficacy (SMD=0.19; 95% CI 0.05-0.33; P=.007) in dementia caregivers. No significant improvements were found in caregiver burden, coping competence, caregiver reactions to behavioral symptoms, or quality of life. Six studies assessed the unintended effects of internet-based supportive intervention access by caregivers on their care recipients. The results showed that internet-based supportive interventions had potential benefits on the quality of life and neuropsychiatric symptoms in care recipients. Conclusions: Internet-based supportive interventions are generally effective at ameliorating depressive symptoms, perceived stress, anxiety, and self-efficacy in dementia caregivers and have potential benefits on care recipients. Future studies are encouraged to adopt personalized internet-based supportive interventions to improve the health of family caregivers and their care recipients. Trial Registration: PROSPERO CRD42020162434; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=162434 %M 32902388 %R 10.2196/19468 %U http://www.jmir.org/2020/9/e19468/ %U https://doi.org/10.2196/19468 %U http://www.ncbi.nlm.nih.gov/pubmed/32902388 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e17285 %T Engagement With Motivational Interviewing and Cognitive Behavioral Therapy Components of a Web-Based Alcohol Intervention, Elicitation of Change Talk and Sustain Talk, and Impact on Drinking Outcomes: Secondary Data Analysis %A Mujcic,Ajla %A Linke,Stuart %A Hamilton,Fiona %A Phillips,Alexandria %A Khadjesari,Zarnie %+ Erasmus School of Social and Behavioural Sciences, Erasmus University Rotterdam, Burgemeester Oudlaan 50, Rotterdam, Netherlands, 31 030 29 59 256, amujcic@trimbos.nl %K eHealth %K digital health %K self-management %K alcohol use %K motivational interviewing %K cognitive behavioural therapy %K engagement %D 2020 %7 1.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Down Your Drink (DYD) is a widely used unguided web-based alcohol moderation program for the general public based on cognitive behavioral therapy (CBT) and motivational interviewing (MI); it provides users with many opportunities to enter free-text responses. Objective: The aim of this study was to assess participants’ use of key CBT and MI components, the presence of change talk and sustain talk within their responses, and whether these data are associated with drinking outcomes after 3 months. Methods: An exploratory secondary data analysis was conducted on data collected in 2008 from the definitive randomized trial of DYD (N=503). Past week alcohol use at baseline and 3-month follow-up were measured with the TOT-AL. Covariates included baseline alcohol use, age, gender, education level, and word count of the responses. Use of MI and CBT components and presence of change talk and sustain talk were coded by two independent coders (Cohen κ range 0.91-1). Linear model regressions on the subsample of active users (n=410) are presented along with a negative binomial regression. Results: The most commonly used component was the listing of pros and cons of drinking. The number of listed high-risk situations was associated with lower alcohol use at 3-month follow-up (Badj −2.15, 95% CI −3.92 to −0.38, P=.02). Findings on the effects of the percentage of change talk and the number of listed strategies to deal with high-risk situations were inconsistent. Conclusions: An unguided web-based alcohol moderation program can elicit change talk and sustain talk. This secondary analysis suggests that the number of listed high-risk situations can predict alcohol use at 3-month follow-up. Other components show inconsistent findings and should be studied further. %M 32870162 %R 10.2196/17285 %U https://www.jmir.org/2020/9/e17285 %U https://doi.org/10.2196/17285 %U http://www.ncbi.nlm.nih.gov/pubmed/32870162 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e18100 %T Effects of Internet-Based Cognitive Behavioral Therapy in Routine Care for Adults in Treatment for Depression and Anxiety: Systematic Review and Meta-Analysis %A Etzelmueller,Anne %A Vis,Christiaan %A Karyotaki,Eirini %A Baumeister,Harald %A Titov,Nickolai %A Berking,Matthias %A Cuijpers,Pim %A Riper,Heleen %A Ebert,David Daniel %+ Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nuremberg, Nägelsbachstr 25a, Erlangen, 91052, Germany, 49 9131 85 67575, anne.etzelmueller@fau.de %K internet-based interventions %K depression %K anxiety %K effectiveness %K acceptability %K routine care %D 2020 %7 31.8.2020 %9 Review %J J Med Internet Res %G English %X Background: Although there is evidence for the efficacy of internet-based cognitive behavioral therapy (iCBT), the generalizability of results to routine care is limited. Objective: This study systematically reviews effectiveness studies of guided iCBT interventions for the treatment of depression or anxiety. Methods: The acceptability (uptake, participants’ characteristics, adherence, and satisfaction), effectiveness, and negative effects (deterioration) of nonrandomized pre-post designs conducted under routine care conditions were synthesized using systematic review and meta-analytic approaches. Results: A total of 19 studies including 30 groups were included in the analysis. Despite high heterogeneity, individual effect sizes of investigated studies indicate clinically relevant changes, with effect sizes ranging from Hedges’ g=0.42-1.88, with a pooled effect of 1.78 for depression and 0.94 for anxiety studies. Uptake, participants’ characteristics, adherence, and satisfaction indicate a moderate to high acceptability of the interventions. The average deterioration across studies was 2.9%. Conclusions: This study provides evidence supporting the acceptability and effectiveness of guided iCBT for the treatment of depression and anxiety in routine care. Given the high heterogeneity between interventions and contexts, health care providers should select interventions that have been proven in randomized controlled clinical trials. The successful application of iCBT may be an effective way of increasing health care in multiple contexts. %M 32865497 %R 10.2196/18100 %U http://www.jmir.org/2020/8/e18100/ %U https://doi.org/10.2196/18100 %U http://www.ncbi.nlm.nih.gov/pubmed/32865497 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e17790 %T Effectiveness of Mobile Health Interventions Promoting Physical Activity and Lifestyle Interventions to Reduce Cardiovascular Risk Among Individuals With Metabolic Syndrome: Systematic Review and Meta-Analysis %A Sequi-Dominguez,Irene %A Alvarez-Bueno,Celia %A Martinez-Vizcaino,Vicente %A Fernandez-Rodriguez,Rubén %A del Saz Lara,Alicia %A Cavero-Redondo,Iván %+ Universidad de Castilla-La Mancha, Health and Social Research Center, Edificio Melchor Cano Campus Universitario de Cuenca, Camino de Pozuelo, s/n, Cuenca, 16071, Spain, 34 969 179 100 ext 4659, celia.alvarezbueno@uclm.es %K mobile health %K mobile technology %K telemedicine %K metabolic syndrome %K physical activity %K lifestyle intervention %K systematic review %K meta-analysis %D 2020 %7 31.8.2020 %9 Review %J J Med Internet Res %G English %X Background: Physical activity and lifestyle interventions, such as a healthy diet, have been proven to be effective approaches to manage metabolic syndrome. However, these interventions require great commitment from patients and clinicians owing to their economic costs, time consumption, and lack of immediate results. Objective: The aim of this systematic review and meta-analysis was to analyze the effect of mobile-based health interventions for reducing cardiometabolic risk through the promotion of physical activity and healthy lifestyle behaviors. Methods: PubMed, Scopus, Web of Science, Cochrane Central Register of Controlled Trials, and SPORTdiscus databases were searched for experimental studies evaluating cardiometabolic risk indicators among individuals with metabolic syndrome who were included in technology-assisted physical activity and lifestyle interventions. Effect sizes, pooled mean changes, and their respective 95% CIs were calculated using the DerSimonian and Laird method. Outcomes included the following clinical and biochemical parameters: body composition (waist circumference [WC] and BMI), blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), glucose tolerance (fasting plasma glucose [FPG] and glycated hemoglobin A1c [HbA1c]), and lipid profile (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and triglycerides). Results: A total of nine studies were included in the meta-analysis. Owing to the scarcity of studies, only pooled mean pre-post changes in the intervention groups were estimated. Significant mean changes were observed for BMI (−1.70 kg/m2, 95% CI −3.20 to −0.20; effect size: −0.46; P=.03), WC (−5.77 cm, 95% CI −9.76 to −1.77; effect size: −0.54; P=.005), SBP (−7.33 mmHg, 95% CI −13.25 to −1.42; effect size: −0.43; P=.02), DBP (−3.90 mmHg, 95% CI −7.70 to −0.11; effect size: −0.44; P=.04), FPG (−3.65 mg/dL, 95% CI −4.79 to −2.51; effect size: −0.39; P<.001), and HDL-C (4.19 mg/dL, 95% CI 2.43-5.95; effect size: 0.23; P<.001). Conclusions: Overall, mobile-based health interventions aimed at promoting physical activity and healthy lifestyle changes had a strong positive effect on cardiometabolic risk indicators among individuals with metabolic syndrome. Nevertheless, further research is required to compare this approach with usual care in order to support the incorporation of these technologies in health systems. Trial Registration: PROSPERO CRD42019125461; https://tinyurl.com/y3t4wog4. %M 32865503 %R 10.2196/17790 %U http://www.jmir.org/2020/8/e17790/ %U https://doi.org/10.2196/17790 %U http://www.ncbi.nlm.nih.gov/pubmed/32865503 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e16437 %T Web-Based Interventions for Dietary Behavior in Adults With Type 2 Diabetes: Systematic Review of Randomized Controlled Trials %A Dening,Jedha %A Islam,Sheikh Mohammed Shariful %A George,Elena %A Maddison,Ralph %+ Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Locked Bag 20000, Geelong, Victoria, 3220, Australia, 61 3 924 68393, shariful.islam@deakin.edu.au %K type 2 diabetes %K dietary behavior %K diet %K glycemic control %K self-management %K eHealth %K web-based %K HbA1c %D 2020 %7 28.8.2020 %9 Review %J J Med Internet Res %G English %X Background: Type 2 diabetes mellitus (T2DM) is among the most prevalent noncommunicable health conditions worldwide, affecting over 500 million people globally. Diet is a key aspect of T2DM management with dietary modification shown to elicit clinically meaningful outcomes such as improved glycemic control, and reductions in weight and cardiovascular disease risk factors. Web-based interventions provide a potentially convenient and accessible method for delivering dietary education, but its effects on dietary behavior in people with T2DM are unknown. Objective: The objective of this review was to determine the effectiveness of web-based interventions on dietary behavior change and glycemic control in people with T2DM. Methods: Per PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, systematic literature searches were performed using Medline, Embase, The Cochrane Library, and CINAHL to retrieve papers from January 2013 to May 2019. Randomized controlled trials of web-based interventions in adults with T2DM with reported dietary assessment were included. Population and intervention characteristics, dietary guidelines and assessments, and significant clinical outcomes were extracted. Differences between groups and within groups were assessed for dietary behavior and clinical outcomes. Results: There were 714 records screened, and five studies comprising 1056 adults were included. Studies measured dietary changes by assessing overall diet quality, changes in specific dietary components, or dietary knowledge scores. Significant improvements in dietary behavior were reported in four out of the five studies, representing healthier food choices, improvements in eating habits, reductions in carbohydrates, added sugar, sodium, saturated fat and overall fat intake, and/or increases in dietary knowledge. Three studies found significant mean reductions for hemoglobin A1c ranging from –0.3% to –0.8%, and/or weight ranging from –2.3 kg to –12.7 kg, fasting blood glucose (–1 mmol/L), waist circumference (–1 cm), and triglycerides (–60.1 mg/dL). These studies provided varied dietary recommendations from standard dietary guidelines, national health program guidelines, and a very low carbohydrate ketogenic diet. Conclusions: This review provided evidence that web-based interventions may be an effective way to support dietary behavior change in people with T2DM, potentially leading to changes in glycemic control and other clinical outcomes. However, the evidence should be viewed as preliminary as there were only five studies included with considerable heterogeneity in terms of the diets recommended, the dietary assessment measures used, the complexity of the interventions, and the modes and methods of delivery. %M 32857059 %R 10.2196/16437 %U http://www.jmir.org/2020/8/e16437/ %U https://doi.org/10.2196/16437 %U http://www.ncbi.nlm.nih.gov/pubmed/32857059 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 7 %N 8 %P e21304 %T Digital Cognitive Behavior Therapy Intervention for Depression and Anxiety: Retrospective Study %A Venkatesan,Aarathi %A Rahimi,Lily %A Kaur,Manpreet %A Mosunic,Christopher %+ Vida Health, 100 Montgomery St, Ste 750, San Francisco, CA, 94104, United States, 1 (415) 989 1017, aarathi.venkatesan@vida.com %K depression %K anxiety %K CBT %K digital mental health intervention %K digital therapeutics %K cognitive behavioral therapy %K therapy %K digital health %K intervention %K mental health %D 2020 %7 26.8.2020 %9 Original Paper %J JMIR Ment Health %G English %X Background: Digital mental health interventions offer a scalable solution that reduces barriers to seeking care for clinical depression and anxiety. Objective: We aimed to examine the effectiveness of a 12-week therapist supported, app-based cognitive behavioral therapy program in improving symptoms of depression and anxiety within 9 months. Methods: A total of 323 participants with mild to moderately severe depression or anxiety were enrolled in a 12-week digital cognitive behavior therapy program. The analysis was restricted to participants who provided at least one follow-up assessment after baseline. As a result, 146 participants (45.2%) were included in the analysis—74 (50.7%) participants completed assessments at 3 months, 31 participants (21.2%) completed assessments at 6 months, and 21 participants (14.4%) completed assessments at 9 months. The program included structured lessons and tools (ie, exercises and practices) as well as one-on-one weekly video counseling sessions with a licensed therapist for 12 weeks and monthly check-in sessions for 1 year. The clinically validated Patient Health Questionnaire (PHQ-8) and Generalized Anxiety Disorder Scale (GAD-7) were used to assess depression and anxiety, respectively. Linear mixed-effects modeling was employed to examine changes in depression and anxiety over time. Results: We observed a significant positive effect of program time on improvement in depression (β=–0.12, P<.001) and anxiety scores (β=–0.10, P<.001). At the end of the 12-week intervention, we observed an average reduction of 3.76 points (95% CI –4.76 to –2.76) in PHQ-8 scores. Further reductions in depression were seen at program month 6 (4.75-point reduction, 95% CI –6.61 to –2.88) and program month 9 (6.42-point reduction, 95% CI –8.66 to –6.55, P<.001). A similar pattern of improvement emerged for anxiety, with a 3.17-point reduction at the end of the 12-week intervention (95% CI –4.21 to –2.13). These improvements were maintained at program month 6 (4.87-point reduction, 95% CI –6.85 to –2.87) and program month 9 (5.19-point, 95% –6.85 to 4.81). In addition, greater program engagement during the first 12 weeks predicted a greater reduction in depression (β=–0.29, P<.001) Conclusions: The results suggest that digital interventions can support sustained and clinically meaningful improvements in depression and anxiety. Furthermore, it appears that strong initial digital mental health intervention engagement may facilitate this effect. However, the study was limited by postintervention participant attrition as well as the retrospective observational study design. %M 32845246 %R 10.2196/21304 %U http://mental.jmir.org/2020/8/e21304/ %U https://doi.org/10.2196/21304 %U http://www.ncbi.nlm.nih.gov/pubmed/32845246 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e17459 %T Information and Communications Technology–Based Interventions Targeting Patient Empowerment: Framework Development %A Karni,Liran %A Dalal,Koustuv %A Memedi,Mevludin %A Kalra,Dipak %A Klein,Gunnar Oskar %+ Centre for Empirical Research on Information Systems, Örebro University School of Business, Fakultetsgatan 1, Örebro, 70281, Sweden, 46 19 301218, liran.karni@oru.se %K empowerment %K ICT intervention %K digital health %K eHealth %K framework model %K ICT patient empowerment model (ICT4PEM) %D 2020 %7 26.8.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Empowerment of patients is often an explicit goal of various information and communications technology (ICT) (electronic, digital) interventions where the patients themselves use ICT tools via the internet. Although several models of empowerment exist, a comprehensive and pragmatic framework is lacking for the development of such interventions. Objective: This study proposes a framework for digital interventions aiming to empower patients that includes a methodology that links objectives, strategies, and evaluation. Methods: This study is based on a literature review and iterated expert discussions including a focus group to formulate the proposed model. Our model is based on a review of various models of empowerment and models of technology intervention. Results: Our framework includes the core characteristics of the empowerment concept (control, psychological coping, self-efficacy, understanding, legitimacy, and support) as well as a set of empowerment consequences: expressed patient perceptions, behavior, clinical outcomes, and health systems effects. The framework for designing interventions includes strategies to achieve empowerment goals using different ICT services. Finally, the intervention model can be used to define project evaluations where the aim is to demonstrate empowerment. The study also included example indicators and associated measurement instruments. Conclusions: This framework, which includes definitions, can be useful for the design and evaluation of digital interventions targeting patient empowerment and assist in the development of methods to measure results in this dimension. Further evaluation in the form of interventional studies will be needed to assess the generalizability of the model. %M 32845245 %R 10.2196/17459 %U http://www.jmir.org/2020/8/e17459/ %U https://doi.org/10.2196/17459 %U http://www.ncbi.nlm.nih.gov/pubmed/32845245 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e17015 %T Improving Patients’ Medication Adherence and Outcomes in Nonhospital Settings Through eHealth: Systematic Review of Randomized Controlled Trials %A Wong,Zoie SY %A Siy,Braylien %A Da Silva Lopes,Katharina %A Georgiou,Andrew %+ Graduate School of Public Health, St. Luke's International University, 5/F, 3-6-2 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan, 81 07041295996, zoiesywong@gmail.com %K eHealth %K self-administered drug %K self-management %K medication adherence %K nonhospital settings %K randomized controlled trial %D 2020 %7 20.8.2020 %9 Review %J J Med Internet Res %G English %X Background: Electronic health (eHealth) refers to the use of information and communication technologies for health. It plays an increasingly important role in patients’ medication management. Objective: To assess evidence on (1) whether eHealth for patients’ medication management can improve drug adherence and health outcomes in nonhospital settings and (2) which eHealth functions are commonly used and are effective in improving drug adherence. Methods: We searched for randomized controlled trials (RCTs) on PubMed, MEDLINE, CINAHL, EMBASE, EmCare, ProQuest, Scopus, Web of Science, ScienceDirect, and IEEE Xplore, in addition to other published sources between 2000 and 2018. We evaluated the studies against the primary outcome measure of medication adherence and multiple secondary health care outcome measures relating to adverse events, quality of life, patient satisfaction, and health expenditure. The quality of the studies included was assessed using the Cochrane Collaboration’s Risk of Bias (RoB) tool. Results: Our initial search yielded 9909 records, and 24 studies met the selection criteria. Of these, 13 indicated improvement in medication adherence at the significance level of P<.1 and 2 indicated an improved quality of life at the significance level of P<.01. The top 3 functions that were employed included mechanisms to communicate with caregivers, monitoring health features, and reminders and alerts. eHealth functions of providing information and education, and dispensing treatment and administration support tended to favor improved medication adherence outcomes (Fisher exact test, P=.02). There were differences in the characteristics of the study population, intervention design, functionality provided, reporting adherence, and outcome measures among the included studies. RoB assessment items, including blinding of outcome assessment and method for allocation concealment, were not explicitly reported in a large number of studies. Conclusions: All the studies included were designed for patient home-based care application and provided a mechanism to communicate with caregivers. A targeted study population such as older patients should be considered to maximize the public health impact on the self-management of diseases. Trial Registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42018096627; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=96627 %M 32663145 %R 10.2196/17015 %U http://www.jmir.org/2020/8/e17015/ %U https://doi.org/10.2196/17015 %U http://www.ncbi.nlm.nih.gov/pubmed/32663145 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 8 %P e17191 %T Two-Way Text Messaging to Support Self-Care and Delivery of an Online Sexual Health Service: Mixed Methods Evaluation %A Shanks,Sarah %A Morelli,Alessandra %A Ardines,Elena %A Holdsworth,Gillian %A Baraitser,Paula %+ SH:24, 35a Westminster Bridge Road, London, SE1 7JB, United Kingdom, 1 02076202250, sshanks@nhs.net %K SMS %K text message %K digital health %K sexual health %K self-care %K mobile phone %D 2020 %7 20.8.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Digital health care is increasingly used to improve health service accessibility and reduce costs. Remote health care requires a significant self-management role for service users, and this generates information provision and support needs that should be reflected in service planning. SMS text messaging offers a convenient and low-cost method of communication and is increasingly used across digital health care services to provide remote support. Objective: The aim of this study was to quantify the number of messages generated through user interaction with a two-way SMS text messaging support service within an online sexual health service and to thematically explore the content of the messages and type of support required to facilitate self-management. Methods: The content of all SMS text messages received by an online sexual health service was analyzed from April 4, 2018, to July 5, 2018. Messages were classified as being either administrative or clinical in nature and service or user initiated. For those messages that were both clinical and user initiated, a qualitative thematic analysis was completed to fully describe the content of the interactions. Results: A total of 267 actionable messages were generated per 1000 orders requested through the service. Of the 8562 messages, 5447 (63.62%) messages were administrative and 3115 (36.38%) were clinical. Overall, 4306 of the 8562 messages (50.29%) responded to service-generated queries reflecting the public health and clinical responsibilities of an online provider, and 4256 (49.71%) were user-generated queries, demonstrating a willingness by users to proactively engage with a two-way SMS text messaging support service. Of the 3115 clinical messages, 968 (31.08%) clinical messages were user initiated and shared personal and complex clinical information, including requests for help with the self-testing process and personalized clinical advice relating to symptoms and treatment. Conclusions: This study demonstrates the willingness of users of an online sexual health service to engage with two-way SMS text messaging and provides insight into the quantity and nature of the support required to facilitate service delivery and self-care. Further work is required to understand the range of clinical problems that can be managed within this medium. %M 32815820 %R 10.2196/17191 %U http://mhealth.jmir.org/2020/8/e17191/ %U https://doi.org/10.2196/17191 %U http://www.ncbi.nlm.nih.gov/pubmed/32815820 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 8 %P e19226 %T Primary Care Peer-Supported Internet-Mediated Psychological Treatment for Adults With Anxiety Disorders: Mixed Methods Study %A Nissling,Linnea %A Fahlke,Claudia %A Lilja,Josefine L %A Skoglund,Ingmarie %A Weineland,Sandra %+ Department of Psychology, University of Gothenburg, Haraldsgatan 1, Gothenburg, 413 14, Sweden, 46 725 029 216, linnea.nissling@vgregion.se %K iCBT %K cognitive behavioral therapy %K internet-based intervention %K anxiety disorders %K primary care %K treatment adherence and compliance %K peer support %D 2020 %7 20.8.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: The effect of internet-delivered cognitive behavioral therapy (iCBT) on anxiety in adults is well-known. However, patient dropouts and poor adherence to treatment are common. Feelings of belonging and empowerment from the treatment might be key to the completion of iCBT. Peer support workers are people with a personal experience of mental health problems, trained to provide professional support to people who require mental health care. Objective: This study aims to assess patient experiences; the feasibility, safety, and acceptability; and preliminary effectiveness on anxiety and depression, empowerment, and adherence to treatment in an 8-week peer-supported iCBT program for patients with anxiety disorders treated in primary care. Methods: This was a single-arm mixed methods feasibility study. Participants were patients referred to a central unit for iCBT in primary care. Quantitative data were collected pre-, post-, and 3 months postintervention. Qualitative data were collected through semistructured interviews. Results: A total of 9 participants completed the quantitative outcome assessment. Statistically significant improvements were observed in perceived empowerment at a 3-month follow-up, and significant decreases in anxiety, depression, and psychological distress at the end of the treatment were maintained at a 3-month follow-up. In total, 8 of the 9 patients showed improvement in the severity of their symptoms of anxiety. Adherence to treatment was good among the participants. No serious adverse events were reported. Eight participants were enrolled in the qualitative analysis. The qualitative results showed 3 main themes: (1) real contact in an online world, (2) empowering experiences, and (3) being behind the wheel. Qualitative results largely emphasized the personal relationship and supported the acceptability of adding peer support to iCBT. Conclusions: Peer support in digital treatment seems to be a safe and acceptable intervention. The preliminary results suggest the effectiveness of peer support on patient empowerment, anxiety, depression, psychological distress, and adherence to treatment. The results indicate the need for future studies to evaluate the effect of adding peer support to iCBT in larger randomized controlled trials. %M 32815819 %R 10.2196/19226 %U http://formative.jmir.org/2020/8/e19226/ %U https://doi.org/10.2196/19226 %U http://www.ncbi.nlm.nih.gov/pubmed/32815819 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 7 %N 8 %P e18642 %T Barriers and Facilitators for Referrals of Primary Care Patients to Blended Internet-Based Psychotherapy for Depression: Mixed Methods Study of General Practitioners’ Views %A Titzler,Ingrid %A Berking,Matthias %A Schlicker,Sandra %A Riper,Heleen %A Ebert,David Daniel %+ Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nürnberg, Nägelsbachstraße 25a, Erlangen, 91052, Germany, 49 91318567567, ingrid.titzler@fau.de %K barriers and facilitators %K general practitioners %K depression %K referral %K blended therapy %K internet-based intervention %K mobile phone %K psychotherapy %K qualitative research %D 2020 %7 18.8.2020 %9 Original Paper %J JMIR Ment Health %G English %X Background: Major depressive disorder (MDD) is highly prevalent and often managed by general practitioners (GPs). GPs mostly prescribe medication and show low referral rates to psychotherapy. Many patients remain untreated. Blended psychotherapy (bPT) combines internet-based interventions with face-to-face psychotherapy and could increase treatment access and availability. Effectively implementing bPT in routine care requires an understanding of professional users’ perspectives and behavior. Objective: This study aims to identify barriers and facilitators perceived by GPs in referring patients to bPT. Explanations for variations in referral rates were examined. Methods: Semistructured interviews were conducted with 12 of 110 GPs participating in a German randomized controlled trial (RCT) to investigate barriers to and facilitators for referrals to bPT for MDD (10 web-based modules, app-based assessments, and 6 face-to-face sessions). The interview guide was based on the theoretical domains framework. The interviews were audio recorded and transcribed verbatim, and the qualitative content was analyzed by 2 independent coders (intercoder agreement, k=0.71). A follow-up survey with 12 interviewed GPs enabled the validation of emergent themes. The differences in the barriers and facilitators identified between groups with different characteristics (eg, GPs with high or low referral rates) were described. Correlations between referrals and characteristics, self-rated competences, and experiences managing depression of the RCT-GPs (n=76) were conducted. Results: GPs referred few patients to bPT, although varied in their referral rates, and interviewees referred more than twice as many patients as RCT-GPs (interview-GPs: mean 6.34, SD 9.42; RCT-GPs: mean 2.65, SD 3.92). A negative correlation was found between GPs’ referrals and their self-rated pharmacotherapeutic competence, r(73)=−0.31, P<.001. The qualitative findings revealed a total of 19 barriers (B) and 29 facilitators (F), at the levels of GP (B=4 and F=11), patient (B=11 and F=9), GP practice (B=1 and F=3), and sociopolitical circumstances (B=3 and F=6). Key barriers stated by all interviewed GPs included “little knowledge about internet-based interventions” and “patients’ lack of familiarity with technology/internet/media” (number of statements, each k=22). Key facilitators were “perceived patient suitability, e.g. well-educated, young” (k=22) and “no conflict with GP’s role” (k=16). The follow-up survey showed a very high agreement rate of at least 75% for 71% (34/48) of the identified themes. Descriptive findings indicated differences between GPs with low and high referral rates in terms of which and how many barriers (low: mean 9.75, SD 1.83; high: mean 10.50, SD 2.38) and facilitators (low: mean 18.25, SD 4.13; high: mean 21.00; SD 3.92) they mentioned. Conclusions: This study provides insights into factors influencing GPs’ referrals to bPT as gatekeepers to depression care. Barriers and facilitators should be considered when designing implementation strategies to enhance referral rates. The findings should be interpreted with care because of the small and self-selected sample and low response rates. %M 32673213 %R 10.2196/18642 %U http://mental.jmir.org/2020/8/e18642/ %U https://doi.org/10.2196/18642 %U http://www.ncbi.nlm.nih.gov/pubmed/32673213 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e19500 %T Adherence of Female Health Care Workers to the Use a Web-Based Tool for Improving and Modifying Lifestyle: Prospective Target Group Pilot Study %A Jukic,Tomislav %A Ihan,Alojz %A Petek Šter,Marija %A Strojnik,Vojko %A Stubljar,David %A Starc,Andrej %+ Institute of Microbiology and Immunology, Ljubljana, Slovenia, 386 40842593, d.stubljar@gmail.com %K mHealth %K eHealth %K health care workers %K occupational stress %K burnout %K adherence %K web-based tool %D 2020 %7 14.8.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Health care professionals are exposed to the psychological and physiological effects of stress, which is a well-known risk factor for various mental and physical health problems. Objective: The aims of this study were to assess the adherence of female health care workers to use a web-based tool for improving and modifying lifestyle and to identify the potential factors influencing their adherence. Methods: A prospective, observational study was performed. A total of 80 female health care workers (physicians and gradated nurses) from 2 university medical centers and female members of a family medicine society participated. Participants completed a questionnaire that inquired about their basic demographic data and physical fitness. Physical fitness was assessed by the Rockport Fitness Walking Test. Adherence to a web-based application (24@life) was followed for 3 months and the number of log-ins into the application was counted. Results: The study was conducted from March to October 2019. Significantly high workload has been detected in all groups (P<.05), except in the general practitioner with normal workload group. The graduated nurse working in the surgery room group showed chronic stress with elevated S-cortisol levels (>690 nmol/L); activated cellular immune system with elevated concentrations of lymphocytes (reference 1.1-2.5 × 109 cells/L), CD3 cells (reference 0.7-1.9 × 109 cells/L), CD8 cells (reference 0.2-0.7 × 109 cells/L), and HLA-DR/CD3 cells (reference 0.04-0.2 × 109 cells/L); and the worst quality of sleep (mean 2.8 [SD 1.2]). Only 32 of 80 participants (40%) were adherent to the web-based application. Participants most frequently viewed web pages on areas of physical activity (497 times) and nutrition (332 times). No factors or participant’s characteristics such as weight (odds ratio [OR] 1.026, 95% CI 0.977-1.078), BMI (OR 0.993, 95% CI 0.834-1.184), age (OR 0.970, 95% CI 0.910-1.034), or stress level (OR 0.997, 95% CI 0.995-1.000) were identified to affect the adherence rates. Conclusions: Female health care workers exposed to high workload did not find the web-based application useful for improving and modifying their lifestyle. Therefore, other strategies that might help health care workers facing stress and improve their lifestyle should be identified. %M 32687475 %R 10.2196/19500 %U https://www.jmir.org/2020/8/e19500 %U https://doi.org/10.2196/19500 %U http://www.ncbi.nlm.nih.gov/pubmed/32687475 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e20368 %T e-INEBRIA Special Interest Group Roadmap for Best Practices for Research on Brief Digital Interventions for Problematic Alcohol and Illicit Drug Use %A Schaub,Michael Patrick %A Berman,Anne H %A López Pelayo,Hugo %A Boumparis,Nikolaos %A Khadjesari,Zarnie %A Blankers,Matthijs %A Gual,Antoni %A Riper,Heleen %A Pas,Lodewijk %+ Swiss Research Institute for Public Health and Addiction ISGF, University of Zurich, Konradstrasse 32, Zurich, 8005, Switzerland, 41 (0) 44 4481165, michael.schaub@isgf.uzh.ch %K brief interventions %K mobile applications %K good practice %K implementation research %K quality assurance %D 2020 %7 14.8.2020 %9 Viewpoint %J J Med Internet Res %G English %X There is great potential for scaling up the delivery of brief interventions for alcohol and illicit drug use, given the increasing coverage of mobile devices and technologies for digital interventions, including apps for smartphones and tablets. However, while the number of digital interventions is increasing rapidly, the involvement of brief-intervention researchers and the development of good practices has just begun. In 2018, the Special Interest Group on digital interventions of the International Network on Brief Interventions for Alcohol & Other Drugs (e-INEBRIA SIG) initiated a conversation regarding possible avenues of future research, which subsequently became a roadmap for digital interventions. This roadmap consists of points considered relevant for future research, ongoing technological developments, and their implementation across a continuum of prevention and care. Moreover, it outlines starting points for the diversification of brief digital interventions, as well as next steps for quality improvement and implementation in public health and clinical practice. The roadmap of the e-INEBRIA SIG on digital interventions is a starting point that indicates relevant next steps and provides orientation for researchers and interested practitioners with regard to the ambiguous literature and the complexity of current digital interventions. %M 32586786 %R 10.2196/20368 %U http://www.jmir.org/2020/8/e20368/ %U https://doi.org/10.2196/20368 %U http://www.ncbi.nlm.nih.gov/pubmed/32586786 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e19861 %T Text Messaging Adherence Intervention for Adolescents and Young Adults with Chronic Kidney Disease: Pilot Randomized Controlled Trial and Stakeholder Interviews %A Eaton,Cyd %A Comer,Margaret %A Pruette,Cozumel %A Psoter,Kevin %A Riekert,Kristin %+ Pulmonary & Critical Care Medicine, Johns Hopkins University School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD, 21224, United States, 1 410 550 3988, ceaton4@jhmi.edu %K medication adherence %K mobile health %K pediatrics %K kidney diseases %K kidney %K mHealth %K adherence %K adolescent %K young adult %K intervention %D 2020 %7 14.8.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Up to one-third of adolescents and young adults (11-21 years old) with chronic kidney disease exhibit suboptimal rates of adherence to renal-protective antihypertensive medications. Mobile health interventions may promote higher adherence to these medicines in these individuals, but empirical research is needed to inform best practices for applying these modalities. Objective: In this multiphase investigation, we developed and tested a theoretically informed text messaging intervention based on the COM-B model, a well-established health intervention framework stating that capability, opportunity, and motivation interactively modify health behaviors, to improve participants’ antihypertensive medication adherence in a pilot randomized controlled trial. Qualitative data on user experiences were obtained. Methods: In phase 1, intervention messages (Reminder+COM-B Message) were developed via stakeholder engagement of participants and pediatric nephrologists. In phase 2, the Reminder+COM-B Message intervention was tested against a Reminder-only Message active control condition in an 8-week pilot randomized controlled trial. The primary outcome was daily electronically monitored antihypertensive medication adherence and secondary outcomes included pre-post participant surveys of adherence self-efficacy, adherence barriers, outcome expectancies for taking medicine, and motivation for and importance of taking medicine. In phase 3, qualitative interviews related to user experiences were conducted with participants in the Reminder+COM-B Message intervention group. Results: Following phase 1, 34 participants (mean age 16.59 years, 41% female, 38% African American/Black, 35% hypertension diagnosis) completed the phase 2 pilot randomized controlled trial (n=18 in the Reminder+COM-B Message intervention group, n=16 in the Reminder-only Message active control group). All participants in the Reminder+COM-B Message intervention group completed a phase 3 qualitative interview. Overall, study procedures were feasible and the Reminder+COM-B Message intervention was acceptable to the participants (eg, 15/18 participants reported reading the majority of messages sent to them, 0/18 reported that the messages reduced their desire to take medicine). Prerandomization, there were no significant group differences in the rate of change in daily adherence over time. However, postrandomization, there was a significant group by time interaction (B=.01, P=.04) in which daily adherence decreased significantly over time in the Reminder-only Message active control group but remained stable in the Reminder+COM-B Message intervention group. There were no significant differences between groups in pre-post changes in survey responses. Qualitative interviews revealed participants’ perceptions of how the Reminder+COM-B Message intervention changed adherence behavior and highlighted several areas for improving the intervention (eg, adapt messaging timing, intensity, and content to match daily adherence, send praise when medicine is taken). Conclusions: The Reminder+COM-B Message intervention was feasible and acceptable to adolescents/young adults and demonstrated potential to promote participants’ daily medication adherence beyond simple reminders. Further research is needed to determine the Reminder+COM-B Message intervention’s mechanisms of adherence behavior change and to incorporate qualitative participant feedback into a modified version of this intervention to enhance its acceptability. Trial Registration: ClinicalTrials.gov NCT03651596; https://clinicaltrials.gov/ct2/show/NCT03651596 %M 32795983 %R 10.2196/19861 %U http://www.jmir.org/2020/8/e19861/ %U https://doi.org/10.2196/19861 %U http://www.ncbi.nlm.nih.gov/pubmed/32795983 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e18355 %T Understanding Self-Guided Web-Based Educational Interventions for Patients With Chronic Health Conditions: Systematic Review of Intervention Features and Adherence %A Xie,Li Feng %A Itzkovitz,Alexandra %A Roy-Fleming,Amelie %A Da Costa,Deborah %A Brazeau,Anne-Sophie %+ School of Human Nutrition, McGill University, 21111 Lakeshore, Ste-Anne-de-Bellevue, Sainte-Anne-de-Bellevue, QC, H9X 3V9, Canada, 1 514 398 7848, anne-sophie.brazeau@mcgill.ca %K chronic disease %K online learning %K self-management %K mobile phone %D 2020 %7 13.8.2020 %9 Review %J J Med Internet Res %G English %X Background: Chronic diseases contribute to 71% of deaths worldwide every year, and an estimated 15 million people between the ages of 30 and 69 years die mainly because of cardiovascular disease, cancer, chronic respiratory diseases, or diabetes. Web-based educational interventions may facilitate disease management. These are also considered to be a flexible and low-cost method to deliver tailored information to patients. Previous studies concluded that the implementation of different features and the degree of adherence to the intervention are key factors in determining the success of the intervention. However, limited research has been conducted to understand the acceptability of specific features and user adherence to self-guided web interventions. Objective: This systematic review aims to understand how web-based intervention features are evaluated, to investigate their acceptability, and to describe how adherence to web-based self-guided interventions is defined and measured. Methods: Studies published on self-guided web-based educational interventions for people (≥14 years old) with chronic health conditions published between January 2005 and June 2020 were reviewed following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement protocol. The search was performed using the PubMed, Cochrane Library, and EMBASE (Excerpta Medica dataBASE) databases; the reference lists of the selected articles were also reviewed. The comparison of the interventions and analysis of the features were based on the published content from the selected articles. Results: A total of 20 studies were included. Seven principal features were identified, with goal setting, self-monitoring, and feedback being the most frequently used. The acceptability of the features was measured based on the comments collected from users, their association with clinical outcomes, or device adherence. The use of quizzes was positively reported by participants. Self-monitoring, goal setting, feedback, and discussion forums yielded mixed results. The negative acceptability was related to the choice of the discussion topic, lack of face-to-face contact, and technical issues. This review shows that the evaluation of adherence to educational interventions was inconsistent among the studies, limiting comparisons. A clear definition of adherence to an intervention is lacking. Conclusions: Although limited information was available, it appears that features related to interaction and personalization are important for improving clinical outcomes and users’ experience. When designing web-based interventions, the selection of features should be based on the targeted population’s needs, the balance between positive and negative impacts of having human involvement in the intervention, and the reduction of technical barriers. There is a lack of consensus on the method of evaluating adherence to an intervention. Both investigations of the acceptability features and adherence should be considered when designing and evaluating web-based interventions. A proof-of-concept or pilot study would be useful for establishing the required level of engagement needed to define adherence. %M 32788152 %R 10.2196/18355 %U http://www.jmir.org/2020/8/e18355/ %U https://doi.org/10.2196/18355 %U http://www.ncbi.nlm.nih.gov/pubmed/32788152 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e17155 %T A Novel Multimodal Digital Service (Moderated Online Social Therapy+) for Help-Seeking Young People Experiencing Mental Ill-Health: Pilot Evaluation Within a National Youth E-Mental Health Service %A Alvarez-Jimenez,Mario %A Rice,Simon %A D'Alfonso,Simon %A Leicester,Steven %A Bendall,Sarah %A Pryor,Ingrid %A Russon,Penni %A McEnery,Carla %A Santesteban-Echarri,Olga %A Da Costa,Gustavo %A Gilbertson,Tamsyn %A Valentine,Lee %A Solves,Laia %A Ratheesh,Aswin %A McGorry,Patrick D %A Gleeson,John %+ Orygen, 35 Poplar Rd, Parkville, 3052, Australia, 61 9966 9383, mario.alvarez@orygen.org.au %K mHealth %K youth %K social media %K social networking %K mobile phone %K internet-based intervention %D 2020 %7 13.8.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Mental ill-health is the leading cause of disability worldwide. Moreover, 75% of mental health conditions emerge between the ages of 12 and 25 years. Unfortunately, due to lack of resources and limited engagement with services, a majority of young people affected by mental ill-health do not access evidence-based support. To address this gap, our team has developed a multimodal, scalable digital mental health service (Enhanced Moderated Online Social Therapy [MOST+]) merging real-time, clinician-delivered web chat counseling; interactive user-directed online therapy; expert and peer moderation; and peer-to-peer social networking. Objective: The primary aim of this study is to ascertain the feasibility, acceptability, and safety of MOST+. The secondary aims are to assess pre-post changes in clinical, psychosocial, and well-being outcomes and to explore the correlations between system use, perceived helpfulness, and secondary outcome variables. Methods: Overall, 157 young people seeking help from a national youth e-mental health service were recruited over 5 weeks. MOST+ was active for 9 weeks. All participants had access to interactive online therapy and integrated web chat counseling. Additional access to peer-to-peer social networking was granted to 73 participants (46.5%) for whom it was deemed safe. The intervention was evaluated via an uncontrolled single-group study. Results: Overall, 93 participants completed the follow-up assessment. Most participants had moderate (52/157, 33%) to severe (96/157, 61%) mental health conditions. All a priori feasibility, acceptability, and safety criteria were met. Participants provided mean scores of ≥3.5 (out of 5) on ease of use (mean 3.7, SD 1.1), relevancy (mean 3.9, SD 1.0), helpfulness (mean 3.5, SD 0.9), and overall experience (mean 3.9, SD 0.8). Moreover, 98% (91/93) of participants reported a positive experience using MOST+, 82% (70/93) reported that using MOST+ helped them feel better, 86% (76/93) felt more socially connected using it, and 92% (86/93) said they would recommend it to others. No serious adverse events or inappropriate use were detected, and 97% (90/93) of participants reported feeling safe. There were statistically significant improvements in 8 of the 11 secondary outcomes assessed: psychological distress (d=−0.39; P<.001), perceived stress (d=−0.44; P<.001), psychological well-being (d=0.51; P<.001), depression (d=−0.29; P<.001), loneliness (d=−0.23; P=.04), social support (d=0.30; P<.001), autonomy (d=0.36; P=.001), and self-competence (d=0.30; P<.001). There were significant correlations between system use, perceived helpfulness, and a number of secondary outcome variables. Conclusions: MOST+ is a feasible, acceptable, and safe online clinical service for young people with mental ill-health. The high level of perceived helpfulness, the significant improvements in secondary outcomes, and the correlations between indicators of system use and secondary outcome variables provide initial support for the therapeutic potential of MOST+. MOST+ is a promising and scalable platform to deliver standalone e-mental health services as well as enhance the growing international network of face-to-face youth mental health services. %M 32788151 %R 10.2196/17155 %U https://www.jmir.org/2020/8/e17155 %U https://doi.org/10.2196/17155 %U http://www.ncbi.nlm.nih.gov/pubmed/32788151 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e17834 %T Impact of a Multicomponent Digital Therapeutic Mobile App on Medication Adherence in Patients with Chronic Conditions: Retrospective Analysis %A Wiecek,Elyssa %A Torres-Robles,Andrea %A Cutler,Rachelle Louise %A Benrimoj,Shalom Isaac %A Garcia-Cardenas,Victoria %+ Graduate School of Health, University of Technology Sydney, , Sydney, , Australia, +61 (02) 9514 9297, victoria.garciacardenas@uts.edu.au %K medication adherence %K medication compliance %K mobile phone %K mobile apps %K mHealth %K gamification %D 2020 %7 12.8.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Strategies to improve medication adherence are widespread in the literature; however, their impact is limited in real practice. Few patients persistently engage long-term to improve health outcomes, even when they are aware of the consequences of poor adherence. Despite the potential of mobile phone apps as a tool to manage medication adherence, there is still limited evidence of the impact of these innovative interventions. Real-world evidence can assist in minimizing this evidence gap. Objective: The objective of this study was to analyze the impact over time of a previously implemented digital therapeutic mobile app on medication adherence rates in adults with any chronic condition. Methods: A retrospective observational study was performed to assess the adherence rates of patients with any chronic condition using Perx Health, a digital therapeutic that uses multiple components within a mobile health app to improve medication adherence. These components include gamification, dosage reminders, incentives, educational components, and social community components. Adherence was measured through mobile direct observation of therapy (MDOT) over 3-month and 6-month time periods. Implementation adherence, defined as the percentage of doses in which the correct dose of a medication was taken, was assessed across the study periods, in addition to timing adherence or percentage of doses taken at the appropriate time (±1 hour). The Friedman test was used to compare differences in adherence rates over time. Results: We analyzed 243 and 130 patients who used the app for 3 months and 6 months, respectively. The average age of the 243 patients was 43.8 years (SD 15.5), and 156 (64.2%) were female. The most common medications prescribed were varenicline, rosuvastatin, and cholecalciferol. The median implementation adherence was 96.6% (IQR 82.1%-100%) over 3 months and 96.8% (IQR 87.1%-100%) over 6 months. Nonsignificant differences in adherence rates over time were observed in the 6-month analysis (Fr(2)=4.314, P=.505) and 3-month analysis (Fr(2)=0.635, P=.728). Similarly, the timing adherence analysis revealed stable trends with no significant changes over time. Conclusions: Retrospective analysis of users of a medication adherence management mobile app revealed a positive trend in maintaining optimal medication adherence over time. Mobile technology utilizing gamification, dosage reminders, incentives, education, and social community interventions appears to be a promising strategy to manage medication adherence in real practice. %M 32784183 %R 10.2196/17834 %U http://www.jmir.org/2020/8/e17834/ %U https://doi.org/10.2196/17834 %U http://www.ncbi.nlm.nih.gov/pubmed/32784183 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e17768 %T Recruiting Adolescents With Chronic Fatigue Syndrome/Myalgic Encephalomyelitis to Internet-Delivered Therapy: Internal Pilot Within a Randomized Controlled Trial %A Anderson,Emma %A Parslow,Roxanne %A Hollingworth,William %A Mills,Nicola %A Beasant,Lucy %A Gaunt,Daisy %A Metcalfe,Chris %A Kessler,David %A Macleod,John %A Pywell,Susan %A Pitts,Kieren %A Price,Simon %A Stallard,Paul %A Knoop,Hans %A Van de Putte,Elise %A Nijhof,Sanne %A Bleijenberg,Gijs %A Crawley,Esther %+ Centre for Academic Child Health, Bristol Medical School: Population Health Sciences, University of Bristol, 1-5 Whiteladies Road, Bristol, United Kingdom, 44 117 4283102, emma.anderson@bristol.ac.uk %K pediatrics %K chronic fatigue syndrome %K myalgic encephalomyelitis %K cognitive behavioral therapy %K eHealth %K online systems %K e-therapy %K e-counseling %K pilot projects %K qualitative research %D 2020 %7 12.8.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) in adolescents is common and disabling. Teenagers in the United Kingdom are more likely to recover if they access specialist care, but most do not have access to a local specialist CFS/ME service. Delivering treatment remotely via the internet could improve access to treatment. Objective: This study aims to assess (1) the feasibility of recruitment and retention into a trial of internet-delivered specialist treatment for adolescents with CFS/ME and (2) the acceptability of trial processes and 2 web-based treatments (to inform continuation to full trial). Methods: This study is an internal pilot for the initial 12 months of a full randomized controlled trial (RCT), with integrated qualitative methods (analysis of recruitment consultations and participant and clinician interviews). Recruitment and treatment were delivered remotely from a specialist pediatric CFS/ME treatment service within a hospital in South West United Kingdom. Adolescents (aged 11-17 years) from across the United Kingdom with a diagnosis of CFS/ME and no access to local specialist treatment were referred by their general practitioner to the treatment center. Eligibility assessment and recruitment were conducted via remote methods (telephone and on the web), and participants were randomized (via a computer-automated system) to 1 of 2 web-based treatments. The trial intervention was Fatigue in Teenagers on the InterNET in the National Health Service, a web-based modular CFS/ME-specific cognitive behavioral therapy program (designed to be used by young people and their parents or caregivers) supported by individualized clinical psychologist electronic consultations (regular, scheduled therapeutic message exchanges between participants and therapist within the platform). The comparator was Skype-delivered activity management with a CFS/ME clinician (mainly a physiotherapist or occupational therapist). Both treatments were intended to last for up to 6 months. The primary outcomes were (1) the number of participants recruited (per out-of-area referrals received between November 1, 2016, to October 31, 2017) and the proportion providing 6-month outcome data (web-based self-report questionnaire assessing functioning) and (2) the qualitative outcomes indicating the acceptability of trial processes and treatments. Results: A total of 89 out of 150 (59.3% of potentially eligible referrals) young people and their parents or caregivers were recruited, with 75 out of 89 (84.2%) providing 6-month outcome data. Overall, web-based treatment was acceptable; however, participants and clinicians described both the advantages and disadvantages of remote methods. No serious adverse events were reported. Conclusions: Recruiting young people (and their parents or caregivers) into an RCT of web-based treatment via remote methods is feasible and acceptable. Delivering specialist treatment at home via the internet is feasible and acceptable, although some families prefer to travel across the United Kingdom for face-to-face treatment. Trial Registration: ISRCTN 18020851; http://www.isrctn.com/ISRCTN18020851 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-018-2500-3 %M 32784188 %R 10.2196/17768 %U https://www.jmir.org/2020/8/e17768 %U https://doi.org/10.2196/17768 %U http://www.ncbi.nlm.nih.gov/pubmed/32784188 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e13234 %T Comment on “Internet-Based Cognitive Behavioral Therapy With Real-Time Therapist Support via Videoconference for Patients With Obsessive-Compulsive Disorder, Panic Disorder, and Social Anxiety Disorder: Pilot Single-Arm Trial” %A Zargaran,David %A Walsh,Caoimhe %A Koumpa,Foteini Stefania %A Ashraf,Muhammad Arsalan %A White,Amelia Jayne %A Patel,Nikhil %A Tanna,Ravina %A Trepekli,Anna %A Zargaran,Alexander %+ St Thomas' Hospital, Westminster Bridge Rd,, London, SE1 7PH, United Kingdom, 44 02071887188, Davidzargaran@gmail.com %K internet %K CBT %K cognitive behavioral therapy %K telemedicine %K telehealth %D 2020 %7 12.8.2020 %9 Letter to the Editor %J J Med Internet Res %G English %X %M 32784172 %R 10.2196/13234 %U https://www.jmir.org/2020/8/e13234 %U https://doi.org/10.2196/13234 %U http://www.ncbi.nlm.nih.gov/pubmed/32784172 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e19882 %T Understanding the Feasibility, Acceptability, and Efficacy of a Clinical Pharmacist-led Mobile Approach (BPTrack) to Hypertension Management: Mixed Methods Pilot Study %A Buis,Lorraine R %A Roberson,Dana N %A Kadri,Reema %A Rockey,Nicole G %A Plegue,Melissa A %A Danak,Shivang U %A Guetterman,Timothy C %A Johnson,Melanie G %A Choe,Hae Mi %A Richardson,Caroline R %+ Department of Family Medicine, University of Michigan, 1018 Fuller Street, Ann Arbor, MI, 48104, United States, 1 734 998 7120, buisl@umich.edu %K cell phone %K mobile phone %K hypertension %K blood pressure %K medication adherence %K telemedicine %K pharmacists %D 2020 %7 11.8.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Hypertension is a prevalent and costly burden in the United States. Clinical pharmacists within care teams provide effective management of hypertension, as does home blood pressure monitoring; however, concerns about data quality and latency are widespread. One approach to close the gap between clinical pharmacist intervention and home blood pressure monitoring is the use of mobile health (mHealth) technology. Objective: We sought to investigate the feasibility, acceptability, and preliminary effectiveness of BPTrack, a clinical pharmacist-led intervention that incorporates patient- and clinician-facing apps to make electronically collected, patient-generated data available to providers in real time for hypertension management. The patient app also included customizable daily medication reminders and educational messages. Additionally, this study sought to understand barriers to adoption and areas for improvement identified by key stakeholders, so more widespread use of such interventions may be achieved. Methods: We conducted a mixed methods pilot study of BPTrack, to improve blood pressure control in patients with uncontrolled hypertension through a 12-week pre-post intervention. All patients were recruited from a primary care setting where they worked with a clinical pharmacist for hypertension management. Participants completed a baseline visit, then spent 12 weeks utilizing BPTrack before returning to the clinic for follow-up. Collected data from patient participants included surveys pre- and postintervention, clinical measures (for establishing effectiveness, with the primary outcome being a change in blood pressure and the secondary outcome being a change in medication adherence), utilization of the BPTrack app, interviews at follow-up, and chart review. We also conducted interviews with key stakeholders. Results: A total of 15 patient participants were included (13 remained through follow-up for an 86.7% retention rate) in a single group, pre-post assessment pilot study. Data supported the hypothesis that BPTrack was feasible and acceptable for use by patient and provider participants and was effective at reducing patient blood pressure. At the 12-week follow-up, patients exhibited significant reductions in both systolic blood pressure (baseline mean 137.3 mm Hg, SD 11.1 mm Hg; follow-up mean 131.0 mm Hg, SD 9.9 mm Hg; P=.02) and diastolic blood pressure (baseline mean 89.4 mm Hg, SD 7.7 mm Hg; follow-up mean 82.5 mm Hg, SD 8.2 mm Hg; P<.001). On average, patients uploaded at least one blood pressure measurement on 75% (SD 25%) of study days. No improvements in medication adherence were noted. Interview data revealed areas of improvement and refinement for the patient experience. Furthermore, stakeholders require integration into the electronic health record and a modified clinical workflow for BPTrack to be truly useful; however, both patients and stakeholders perceived benefits of BPTrack when used within the context of a clinical relationship. Conclusions: Results demonstrate that a pharmacist-led mHealth intervention promoting home blood pressure monitoring and clinical pharmacist management of hypertension can be effective at reducing blood pressure in primary care patients with uncontrolled hypertension. Our data also support the feasibility and acceptability of these types of interventions for patients and providers. Trial Registration: ClinicalTrials.gov NCT02898584; https://clinicaltrials.gov/ct2/show/NCT02898584 International Registered Report Identifier (IRRID): RR2-10.2196/resprot.8059 %M 32780026 %R 10.2196/19882 %U https://www.jmir.org/2020/8/e19882 %U https://doi.org/10.2196/19882 %U http://www.ncbi.nlm.nih.gov/pubmed/32780026 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e17593 %T Effects of a Brief Electronic Mindfulness-Based Intervention on Relieving Prenatal Depression and Anxiety in Hospitalized High-Risk Pregnant Women: Exploratory Pilot Study %A Goetz,Maren %A Schiele,Claudia %A Müller,Mitho %A Matthies,Lina M %A Deutsch,Thomas M %A Spano,Claudio %A Graf,Johanna %A Zipfel,Stephan %A Bauer,Armin %A Brucker,Sara Y %A Wallwiener,Markus %A Wallwiener,Stephanie %+ Department of Obstetrics and Gynecology, University of Heidelberg, Im Neuenheimer Feld 440, Heidelberg, 69120, Germany, 49 6221 5636956, stephanie.wallwiener@googlemail.com %K pregnancy %K high-risk pregnancy %K hospitalization %K preterm labor %K anxiety %K depression %K psychological stress %K mindfulness %K stress reduction %K mobile app %D 2020 %7 11.8.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Peripartum depression and anxiety disorders are highly prevalent and are correlated with adverse maternal and neonatal outcomes. Antenatal care in Germany does not yet include structured screening and effective low-threshold treatment options for women facing peripartum depression and anxiety disorders. Mindfulness-based interventions (MBIs) are increasingly becoming a focus of interest for the management of such patients. Studies have shown a decrease in pregnancy-related stress and anxiety in expectant mothers following mindfulness programs. Objective: The aim of this study was to explore the clinical effectiveness of a 1-week electronic course of mindfulness on prenatal depression and anxiety in hospitalized, high-risk pregnant women. We hypothesized that participating in a 1-week electronic MBI (eMBI) could alleviate symptoms of depression and anxiety during the hospital stay. Methods: A prospective pilot study with an explorative study design was conducted from January to May 2019 in a sample of 68 women hospitalized due to high-risk pregnancies. After enrolling into the study, the participants were given access to an eMBI app on how to deal with stress, anxiety, and symptoms of depression. Psychometric parameters were assessed via electronic questionnaires comprising the Edinburgh Postnatal Depression Scale (EPDS), State-Trait Anxiety Inventory (STAI-S), and abridged version of the Pregnancy-Related Anxiety Questionnaire (PRAQ-R). Results: We observed a high prevalence of peripartum depression and anxiety among hospitalized high-risk pregnant women: 39% (26/67) of the study participants in the first assessment and 41% (16/39) of the participants in the second assessment achieved EPDS scores above the cutoff value for minor/major depression. The number of participants with anxiety levels above the cutoff value (66% [45/68] of the participants in the first assessment and 67% [26/39] of the participants in the second assessment) was significantly more than that of the participants with anxiety levels below the cutoff value, as measured with the STAI-S. After completing the 1-week electronic course on mindfulness, the participants showed a significant reduction in the mean state anxiety levels (P<.03). Regarding pregnancy-related anxiety, participants who completed more than 50% of the 1-week course showed lower scores in PRAQ-R in the second assessment (P<.05). No significant changes in the EPDS scores were found after completing the intervention. Conclusions: Peripartum anxiety and depression represent a relevant health issue in hospitalized pregnant patients. Short-term eMBIs could have the potential to reduce anxiety levels and pregnancy-related anxiety. However, we observed that compliance to eMBI seems to be related to lower symptoms of pregnancy-related stress among high-risk patients. eMBIs represent accessible mental health resources at reduced costs and can be adapted for hospitalized patients during pregnancy. %M 32780023 %R 10.2196/17593 %U https://www.jmir.org/2020/8/e17593 %U https://doi.org/10.2196/17593 %U http://www.ncbi.nlm.nih.gov/pubmed/32780023 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e17521 %T Understanding Time Series Patterns of Weight and Meal History Reports in Mobile Weight Loss Intervention Programs: Data-Driven Analysis %A Kim,Junetae %A Kam,Hye Jin %A Kim,Youngin %A Lee,Yura %A Lee,Jae-Ho %+ Department of Information Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea, 82 3010 3350, rufiji@gmail.com %K weight loss %K self-reporting %K adherence %K mobile weight loss intervention %K diet %D 2020 %7 11.8.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Mobile apps for weight loss provide users with convenient features for recording lifestyle and health indicators; they have been widely used for weight loss recently. Previous studies in this field generally focused on the relationship between the cumulative nature of self-reported data and the results in weight loss at the end of the diet period. Therefore, we conducted an in-depth study to explore the relationships between adherence to self-reporting and weight loss outcomes during the weight reduction process. Objective: We explored the relationship between adherence to self-reporting and weight loss outcomes during the time series weight reduction process with the following 3 research questions: “How does adherence to self-reporting of body weight and meal history change over time?”, “How do weight loss outcomes depend on weight changes over time?”, and “How does adherence to the weight loss intervention change over time by gender?” Methods: We analyzed self-reported data collected weekly for 16 weeks (January 2017 to March 2018) from 684 Korean men and women who participated in a mobile weight loss intervention program provided by a mobile diet app called Noom. Analysis of variance (ANOVA) and chi-squared tests were employed to determine whether the baseline characteristics among the groups of weight loss results were different. Based on the ANOVA results and slope analysis of the trend indicating participant behavior along the time axis, we explored the relationship between adherence to self-reporting and weight loss results. Results: Adherence to self-reporting levels decreased over time, as previous studies have found. BMI change patterns (ie, absolute BMI values and change in BMI values within a week) changed over time and were characterized in 3 time series periods. The relationships between the weight loss outcome and both meal history and self-reporting patterns were gender-dependent. There was no statistical association between adherence to self-reporting and weight loss outcomes in the male participants. Conclusions: Although mobile technology has increased the convenience of self-reporting when dieting, it should be noted that technology itself is not the essence of weight loss. The in-depth understanding of the relationship between adherence to self-reporting and weight loss outcome found in this study may contribute to the development of better weight loss interventions in mobile environments. %M 32780028 %R 10.2196/17521 %U https://www.jmir.org/2020/8/e17521 %U https://doi.org/10.2196/17521 %U http://www.ncbi.nlm.nih.gov/pubmed/32780028 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e16725 %T Meeting Kids Where They Are At–A Substance Use and Sexual Risk Prevention Program via Telemedicine for African American Girls: Usability and Acceptability Study %A Lopez,Cristina %A Gilmore,Amanda K %A Moreland,Angela %A Danielson,Carla Kmett %A Acierno,Ron %+ Medical University of South Carolina, 99 Jonathan Lucas Street, MSC 161, Charleston, SC, 29425, United States, 1 8438761034, lopezcm@musc.edu %K adolescents %K substance use %K sexual risk reduction %K telehealth %K prevention programs %K mobile phone %D 2020 %7 11.8.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Rural African American youth lack access to drug and sexual risk–taking prevention programs available in more urban areas. Recent data indicate that rural youth now use substances at higher rates and at younger ages than their urban peers. Objective: This study aims to evaluate the initial usability and acceptability of a low-cost, technology-based approach to delivering effective, culturally tailored, integrated substance use disorder (SUD) and HIV risk behavior prevention programs to African American female youth to inform the use of this intervention via telemedicine for rural youth. Methods: Effective SUD prevention strategies and emotion regulation skills were integrated into an existing evidence-based HIV risk reduction program culturally tailored for African American female adolescents—Sisters Informing, Healing, Living, and Empowering (SIHLE)—and delivered to 39 African American female youth via group telehealth. The evaluation of the resulting program, 12-session SIHLEplus, was completed by 27 girls who also completed self-report measures that assessed sexual risk behaviors (eg, number of partners and age of sex initiation), substance use, exposure to traumatic events, and emotion regulation. Results: The descriptive and qualitative results of the pilot study demonstrate the initial usability and acceptability of delivering evidence-based prevention successfully via telehealth to help address health disparities in this vulnerable population. Conclusions: Although more research is needed, the findings from this study suggest that SIHLEplus has demonstrated initial usability and acceptability. %M 32780022 %R 10.2196/16725 %U http://www.jmir.org/2020/8/e16725/ %U https://doi.org/10.2196/16725 %U http://www.ncbi.nlm.nih.gov/pubmed/32780022 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e16961 %T Perceived Effectiveness and Motivations for the Use of Web-Based Mental Health Programs: Qualitative Study %A Eccles,Heidi %A Nannarone,Molly %A Lashewicz,Bonnie %A Attridge,Mark %A Marchand,Alain %A Aiken,Alice %A Ho,Kendall %A Wang,Jianli %+ Work & Mental Health Research Unit, The Institute of Mental Health Research, University of Ottawa, Room 5404, 1145 Carling Ave, Ottawa, ON, K1Z7K4, Canada, 1 6137226521, jianli.wang@theroyal.ca %K prevention %K mental health %K depression %K cognitive behavioral therapy %K motivators %K perceived effectiveness %K internet-based intervention %K interview %D 2020 %7 31.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: The prevalence of depression is high and has been stable despite increased treatment, research, and dissemination. People encounter barriers to seeking traditional mental health services, which could be mitigated by using web-based prevention methods. Objective: This study aims to understand what people at high risk for depression perceive as effective aspects of web-based mental health programs and what motivates people at high risk for depression to use web-based mental health programs. Methods: We conducted an inductive content analysis using telephone interview data from 77 participants at high risk for depression who were recruited from 2 randomized controlled trials (RCTs). Participants from the first RCT were working men who had been randomly assigned to 1 of the following 3 groups: control group, who had access to general depression information from a website called BroMatters; intervention group 1, who had access to the BroMatters website along with the associated BroHealth web-based mental health program; and intervention group 2, who had access to the BroMatters website, the BroHealth web-based mental health program, and telephone sessions with a life coach. Participants from the second RCT were men and women who had been assigned to the intervention group, who received access to the HardHat web-based mental health program, or the control group, who only received access to the HardHat web-based mental health program following completion of the RCT. Participants for this inductive content analysis study were recruited from the intervention groups in both RCTs. Two groups of participants (n=41 and n=20) were recruited from the BroHealth RCT, and a third group comprised 16 participants that were recruited from the HardHat RCT. Results: We generated four categories regarding the perceived effectiveness of web-based programs and five categories related to what motivates the use of web-based programs. Participants identified awareness, program medium and functionality, program content, and coaches as categories related to the effectiveness of the programs. Categories of motivators to use web-based programs included providing reminders or incentives, promotion of the programs, providing appropriate medium and functionality, appropriate content, and perceived need. The final category related to motivators reflects perceptions of participants who were either unsure about what motivates them or believed that there is no way to motivate use. Conclusions: Conflicting evidence was obtained regarding the perceived effectiveness of aspects of the content and functionality of web-based programs. In general, web-based mental health programs were perceived to help increase mental health awareness, especially when it includes live access to a coach. However, the results also revealed that it is difficult to motivate people to begin using web-based mental health programs. Strategies that may motivate the use of such programs include perceived personal need, effective promotion, providing incentives and reminders, and improving functionality. %M 32735216 %R 10.2196/16961 %U http://www.jmir.org/2020/7/e16961/ %U https://doi.org/10.2196/16961 %U http://www.ncbi.nlm.nih.gov/pubmed/32735216 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e15378 %T Participatory Interventions for Sexual Health Promotion for Adolescents and Young Adults on the Internet: Systematic Review %A Martin,Philippe %A Cousin,Lorraine %A Gottot,Serge %A Bourmaud,Aurelie %A de La Rochebrochard,Elise %A Alberti,Corinne %+ Université de Paris, ECEVE, INSERM, 10 Avenue de Verdun, Paris, 75010, France, 33 676606491, philippe.martin@inserm.fr %K sexual health %K health promotion %K internet %K participatory interventions %K adolescents and young adults %K methods %D 2020 %7 31.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: The World Health Organization recommends the development of participatory sexuality education. In health promotion, web-based participatory interventions have great potential in view of the internet’s popularity among young people. Objective: The aim of this review is to describe existing published studies on online participatory intervention methods used to promote the sexual health of adolescents and young adults. Methods: We conducted a systematic review based on international scientific and grey literature. We used the PubMed search engine and Aurore database for the search. Articles were included if they reported studies on participatory intervention, included the theme of sexual health, were conducted on the internet (website, social media, online gaming system), targeted populations aged between 10 and 24 years, and had design, implementation, and evaluation methods available. We analyzed the intervention content, study implementation, and evaluation methods for all selected articles. Results: A total of 60 articles were included, which described 37 interventions; several articles were published about the same intervention. Process results were published in many articles (n=40), in contrast to effectiveness results (n=23). Many of the 37 interventions were developed on websites (n=20). The second most used medium is online social networks (n=13), with Facebook dominating this group (n=8). Online peer interaction is the most common participatory component promoted by interventions (n=23), followed by interaction with a professional (n=16). Another participatory component is game-type activity (n=10). Videos were broadcast for more than half of the interventions (n=20). In total, 43% (n=16) of the interventions were based on a theoretical model, with many using the Information-Motivation-Behavioral Skills model (n=7). Less than half of the interventions have been evaluated for effectiveness (n=17), while one-third (n=12) reported plans to do so and one-fifth (n=8) did not indicate any plan for effectiveness evaluation. The randomized controlled trial is the most widely used study design (n=16). Among the outcomes (evaluated or planned for evaluation), sexual behaviors are the most evaluated (n=14), followed by condom use (n=11), and sexual health knowledge (n=8). Conclusions: Participatory online interventions for young people’s sexual health have shown their feasibility, practical interest, and attractiveness, but their effectiveness has not yet been sufficiently evaluated. Online peer interaction, the major participatory component, is not sufficiently conceptualized and defined as a determinant of change or theoretical model component. One potential development would be to build a conceptual model integrating online peer interaction and support as a component. %M 32735217 %R 10.2196/15378 %U http://www.jmir.org/2020/7/e15378/ %U https://doi.org/10.2196/15378 %U http://www.ncbi.nlm.nih.gov/pubmed/32735217 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e17031 %T Effects of the e-Motivate4Change Program on Metabolic Syndrome in Young Adults Using Health Apps and Wearable Devices: Quasi-Experimental Study %A Lee,Ji-Soo %A Kang,Min-Ah %A Lee,Soo-Kyoung %+ Keimyung University, 1095 Dalgubeol-daero, Dalseo-Gu, Daegu, 42601, Republic of Korea, 82 53 258 7665, soo1005s@gmail.com %K metabolic syndrome %K telemedicine %K mobile apps %K preventive care %K wearable electronic devices %D 2020 %7 30.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: The health behaviors of young adults lag behind those of other age groups, and active health management is needed to improve health behaviors and prevent chronic diseases. In addition, developing good lifestyle habits earlier in life could reduce the risk of metabolic syndrome (MetS) later on. Objective: The aim of this study is to investigate the effects of the e-Motivate4Change program, for which health apps and wearable devices were selected based on user needs. The program was developed for the prevention and management of MetS in young adults. Methods: This experimental study used a nonequivalent control group. In total, 59 students from 2 universities in Daegu, Korea participated in the study (experimental group n=30; control group n=29). Data were collected over 4 months, from June 1 to September 30, 2018. The experimental group received a 12-week e-Motivate4Change program intervention, and the control group received MetS education and booklets without the e-Motivate4Change program intervention. Results: After the program, the experimental group had significantly higher scores for health-related lifestyle (t=3.86; P<.001) and self-efficacy (t=6.00; P<.001) than did the control group. Concerning BMI, there were significant effects by group (F=1.01; P<.001) and for the group × time interaction (F=4.71; P=.034). Concerning cholesterol, there were significant main effects for group (F=4.32; P=.042) and time (F=9.73; P<.001). Conclusions: The e-Motivate4Change program effectively improved participants’ health-related lifestyle scores and self-efficacy, and significantly reduced their BMI and cholesterol levels. The program can be used to identify and prevent MetS among young adults. %M 32729838 %R 10.2196/17031 %U http://www.jmir.org/2020/7/e17031/ %U https://doi.org/10.2196/17031 %U http://www.ncbi.nlm.nih.gov/pubmed/32729838 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e17481 %T A Mobile Health Approach for Improving Outcomes in Suicide Prevention (SafePlan) %A O'Grady,Conor %A Melia,Ruth %A Bogue,John %A O'Sullivan,Mary %A Young,Karen %A Duggan,Jim %+ School of Computer Science, National University of Ireland Galway, University Road, Galway, H91 TK33, Ireland, 353 91493336, james.duggan@nuigalway.ie %K mobile apps %K suicide %K mHealth %D 2020 %7 30.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Suicide is a prominent cause of death worldwide, particularly among young people. It was the second leading cause of death among those aged 15-29 years globally in 2016. Treatment for patients with suicidal thoughts or behaviors often includes face-to-face psychological therapy with a mental health professional. These forms of interventions may involve maintaining and updating paper-based reports or worksheets in between sessions. Mobile technology can offer a way to support the implementation of evidence-based psychological techniques and the acquisition of protective coping skills. Objective: This study aims to develop a mobile app to facilitate service users’ access to mental health support and safety planning. This process involved eliciting expert input from clinicians who are actively engaged in the provision of mental health care. Methods: A survey was distributed to targeted health care professionals to determine what features should be prioritized in a new mobile app relating to suicide prevention. On the basis of the survey results, a clinical design group, comprising 6 members with experience in fields such as mobile health (mHealth), clinical psychology, and suicide prevention, was established. This group was supplemented with further input from additional clinicians who provided feedback over three focus group sessions. The sessions were centered on refining existing app components and evaluating new feature requests. This process was iterated through regular feedback until agreement was reached on the overall app design and functionality. Results: A fully functional mobile app, known as the SafePlan app, was developed and tested with the input of clinicians through an iterative design process. The app’s core function is to provide an interactive safety plan to support users with suicidal thoughts or behaviors as an adjunct to face-to-face therapy. A diary component that facilitates the generalization of skills learned through dialectical behavior therapy was also implemented. Usability testing was carried out on the final prototype by students from a local secondary school, who are representative of the target user population in both age and technology experience. The students were asked to complete a system usability survey (SUS) at the end of this session. The mean overall SUS rating was 71.85 (SD 1.38). Conclusions: The participatory process involving key stakeholders (clinicians, psychologists, and information technology specialists) has resulted in the creation of an mHealth intervention technology that has the potential to increase accessibility to this type of mental health service for the target population. The app has gone through the initial testing phase, and the relevant recommendations have been implemented, and it is now ready for trialing with both clinicians and their patients. %M 32729845 %R 10.2196/17481 %U http://www.jmir.org/2020/7/e17481/ %U https://doi.org/10.2196/17481 %U http://www.ncbi.nlm.nih.gov/pubmed/32729845 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e18157 %T Designing a Personalized Digital Patient Support Program for Patients Treated With Growth Hormone: Key Design Considerations %A Malik,Sumaira %A Moloney,Clare %A Koledova,Ekaterina %A Reston,Jonathan %A Weinman,John %+ Atlantis Healthcare, Building 5 Chiswick Park, Chiswick High Road, London, W4 5YA, United Kingdom, 44 2087474360, sumaira.malik@atlantishealthcare.com %K growth hormone %K behavior change wheel %K somatropin %K adherence %D 2020 %7 29.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Recombinant human growth hormone treatment can optimize growth potential; however, optimal outcomes are not always achieved for several reasons, including poor adherence. The overall objective of this project was to design a patient support program to maximize the chances of treatment success for people being treated with somatropin injection. An approach known as the behavior change wheel was used to enhance the development of the patient support program. The behavior change wheel provided a comprehensive framework to support the design of interventions. Objective: The aim of this paper was to describe how the steps of the behavior change wheel were applied to the development of a patient support program for individuals with growth hormone deficiency undergoing treatment with somatropin. Methods: We followed a series of steps that align to tenets of the behavior change wheel, namely, a narrative literature review to identify which behaviors needed to change and the potential drivers of and barriers to the behaviors, the selection of an intervention strategy and discrete behavior change techniques, and, finally, intervention specification. Results: A recent systematic review identified a range of potentially modifiable factors found to have an influence on patient adherence to growth hormone treatment. Insights from the systematic review were used to guide the development of a patient support program. The final design of the patient support program consisted of four elements: (1) a personalization questionnaire to tailor support for each individual, (2) tailored reminder and support SMS text messages, (3) nurse-led phone calls, and (4) Easypod connect, an automated electronic autoinjector drug-delivery device with a transmitter and connection platform for Saizen (somatropin) that allows automatic recording, storage, and transmission of drug-usage data, thus providing insight into suboptimal adherence. Conclusions: The patient support program that was designed is currently being piloted with patients to assess engagement with the program and determine its impact on patient outcomes. Results from the pilot will be used to further refine the program to ensure it meets user needs. %M 32723712 %R 10.2196/18157 %U http://www.jmir.org/2020/7/e18157/ %U https://doi.org/10.2196/18157 %U http://www.ncbi.nlm.nih.gov/pubmed/32723712 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e17915 %T Evidence Regarding Automatic Processing Computerized Tasks Designed For Health Interventions in Real-World Settings Among Adults: Systematic Scoping Review %A Jayasinghe,Harshani %A Short,Camille E %A Braunack-Mayer,Annette %A Merkin,Ashley %A Hume,Clare %+ School of Public Health, The University of Adelaide, Level 9, Adelaide Health and Medical Sciences Building, The University of Adelaide, Adelaide, 5000, Australia, 61 8313 4634, harshani.jayasinghepedige@adelaide.edu.au %K automatic processing %K computerized tasks %K health interventions %K real-world %K adult %K behavior change, mobile phone %D 2020 %7 29.7.2020 %9 Review %J J Med Internet Res %G English %X Background: Dual process theories propose that the brain uses 2 types of thinking to influence behavior: automatic processing and reflective processing. Automatic processing is fast, immediate, nonconscious, and unintentional, whereas reflective processing focuses on logical reasoning, and it is slow, step by step, and intentional. Most digital psychological health interventions tend to solely target the reflective system, although the automatic processing pathway can have strong influences on behavior. Laboratory-based research has highlighted that automatic processing tasks can create behavior change; however, there are substantial gaps in the field on the design, implementation, and delivery of automatic processing tasks in real-world settings. It is important to identify and summarize the existing literature in this area to inform the translation of laboratory-based research to real-world settings. Objective: This scoping review aims to explore the effectiveness of automatic training tasks, types of training tasks commonly used, mode of delivery, and impacts of gamification on automatic processing tasks designed for digital psychological health interventions in real-world settings among adults. Methods: The scoping review methodology proposed by Arskey and O’Malley and Colquhoun was applied. A scoping review was chosen because of the novelty of the digital automatic processing field and to encompass a broad review of the existing evidence base. Electronic databases and gray literature databases were searched with the search terms “automatic processing,” “computerised technologies,” “health intervention,” “real-world,” and “adults” and synonyms of these words. The search was up to date until September 2018. A manual search was also completed on the reference lists of the included studies. Results: A total of 14 studies met all inclusion criteria. There was a wide variety of health conditions targeted, with the most prevalent being alcohol abuse followed by social anxiety. Attention bias modification tasks were the most prevalent type of automatic processing task, and the majority of tasks were most commonly delivered over the web via a personal computer. Of the 14 studies included in the review, 8 demonstrated significant changes to automatic processes and 4 demonstrated significant behavioral changes as a result of changed automatic processes. Conclusions: This is the first review to synthesize the evidence on automatic processing tasks in real-world settings targeting adults. This review has highlighted promising, albeit limited, research demonstrating that automatic processing tasks may be used effectively in a real-world setting to influence behavior change. %M 32499213 %R 10.2196/17915 %U http://www.jmir.org/2020/7/e17915/ %U https://doi.org/10.2196/17915 %U http://www.ncbi.nlm.nih.gov/pubmed/32499213 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e16234 %T Teens Taking Charge: A Randomized Controlled Trial of a Web-Based Self-Management Program With Telephone Support for Adolescents With Juvenile Idiopathic Arthritis %A Stinson,Jennifer N %A Lalloo,Chitra %A Hundert,Amos S %A Campillo,Sarah %A Cellucci,Tania %A Dancey,Paul %A Duffy,Ciaran %A Ellsworth,Janet %A Feldman,Brian M %A Huber,Adam M %A Johnson,Nicole %A Jong,Geert't %A Oen,Kiem %A Rosenberg,Alan M %A Shiff,Natalie J %A Spiegel,Lynn %A Tse,Shirley M L %A Tucker,Lori %A Victor,Joseph Charles %+ The Hospital for Sick Children, 555 University Ave, Toronto, ON, Canada, 1 (416) 8131500, jennifer.stinson@sickkids.ca %K eHealth %K randomized controlled trial %K adolescents %K juvenile idiopathic arthritis %K self-management %K self-efficacy %K technology %K patient education %K internet %K pediatric pain %D 2020 %7 29.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Juvenile idiopathic arthritis (JIA) is a serious and potentially debilitating pediatric illness. Improved disease self-management may help to improve health outcomes. Objective: This study aimed to evaluate the effectiveness of the Teens Taking Charge Web-based self-management intervention in reducing symptoms and improving health-related quality of life (HRQL) in adolescents with JIA compared with a Web-based education control condition. Methods: Adolescents with JIA aged 12 to 18 years were recruited from 11 Canadian pediatric rheumatology centers. Caregivers were invited to participate along with their child. In addition to standard medical care, participants were randomized to receive either (1) the Teens Taking Charge self-management intervention or (2) a Web-based education control condition for a period of 12 weeks. Adolescents in the intervention group completed website modules addressing cognitive behavioral coping skills, stress management, and other self-management topics, while also receiving monthly telephone calls from a trained health coach. Adolescents in the education control group were instructed to view a series of preselected public JIA educational websites and received monthly calls from a coach who asked about their own best efforts at managing JIA. Caregivers in the intervention group completed website modules related to promoting independence and disease self-management in their child. Caregivers in the education control group were instructed to view a series of preselected public JIA educational websites. Outcome assessment occurred at baseline, 12 weeks (posttreatment), and at 6 and 12 months postrandomization. The primary outcomes were pain intensity, pain interference, and HRQL. Secondary outcomes were emotional symptoms, adherence, coping, knowledge, and self-efficacy. Results: In total, 333 adolescents and 306 caregivers were enrolled. Significant overall reductions in pain intensity (P=.02) and pain interference (P=.007) were observed for intervention group participants compared with those in the education control group, after adjusting for baseline levels. There was a significant overall improvement in HRQL related to problems with pain (P=.02) and problems with daily activities (P=.01). There was also a significant difference in the intervention group over time (P=.008) for HRQL related to treatment problems, with the intervention group participants demonstrating improved HRQL by 12 months compared with education control group participants. Both groups showed nonsignificant improvements compared with baseline in other primary outcomes. There were no significant differences between the groups in any secondary outcomes or caregiver-reported outcomes. Conclusions: The results of this randomized trial suggest that the Teens Taking Charge Web-based intervention is effective at reducing both pain intensity and pain interference, as well as improving HRQL in adolescents with JIA, compared with education control. These effects are sustained for up to 12 months following program completion. The Teens Taking Charge program is now publicly available at no cost. Trial Registration: ClinicalTrials.gov NCT01572896; https://clinicaltrials.gov/ct2/show/NCT01572896 %M 32723728 %R 10.2196/16234 %U https://www.jmir.org/2020/7/e16234 %U https://doi.org/10.2196/16234 %U http://www.ncbi.nlm.nih.gov/pubmed/32723728 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e17673 %T Impact of an Electronic Health Service on Child Participation in Pediatric Oncology Care: Quasiexperimental Study %A Gilljam,Britt-Mari %A Nygren,Jens M %A Svedberg,Petra %A Arvidsson,Susann %+ School of Health and Welfare, Halmstad University, Box 823, Halmstad, 301 18, Sweden, 46 35 16 71 00, Britt-mari.gilljam@hh.se %K cancer %K child care %K communication %K eHealth %K patient participation %D 2020 %7 28.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: For children 6-12 years old, there is a shortage of electronic Health (eHealth) services that promote their participation in health care. Therefore, a digital communication tool, called Sisom, was developed to give children a voice in their health care. Children with long-term diseases want to be more involved in their health care and have the right to receive information, be listened to, express their opinions, and participate in decision making in health care. However, the outcomes of using Sisom in practice at pediatric oncology clinics have not been investigated. Objective: The aim of this study was to investigate children’s participation during appointments with pediatricians at pediatric oncology clinics, with or without the use of the eHealth service Sisom. Methods: A quasiexperimental design with mixed methods was used. We analyzed 27 filmed appointments with pediatricians for 14 children (8 girls and 6 boys) aged 6-12 years (mean 8.3 years) with a cancer diagnosis. The intervention group consisted of children who used Sisom prior to their appointments with pediatricians at a pediatric oncology clinic, and the control group consisted of children who had appointments with pediatricians at 4 pediatric oncology clinics. Data from observations from the videos were quantitatively and qualitatively analyzed. The quantitative analysis included manual calculations of how many times the pediatricians spoke directly to the children, the proportion of the appointment time that the children were talking, and levels of participation by the children. For the qualitative analysis, we used directed content analysis to analyze the children’s levels of participation guided by a framework based on Shier’s model of participation. Results: Pediatricians directed a greater proportion of their discussion toward the child in the intervention group (731 occasions) than in the control group (624 occasions), but the proportion of the appointment time the children talked was almost the same for both the intervention and control groups (mean 17.0 minutes vs 17.6 minutes). The levels of participation corresponded to the first three levels of Shier’s participation model: children were listened to, children were supported to express their views, and children’s views were taken into account. The results showed an increased level of participation by the children in the intervention group. Several codes that were found did not fit into any of the existing categories, and a new category was thus formed: children received information. Conclusions: This study shows that the eHealth service Sisom can increase children’s participation during appointments with health care professionals. Further studies employing a randomized control design focusing on the effects of eHealth services on children’s health outcomes, perceived participation, and cost-effectiveness could make a significant contribution to guiding the implementation of eHealth services in pediatric care. %M 32720907 %R 10.2196/17673 %U http://www.jmir.org/2020/7/e17673/ %U https://doi.org/10.2196/17673 %U http://www.ncbi.nlm.nih.gov/pubmed/32720907 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e17351 %T Changing the Health Behavior of Patients With Cardiovascular Disease Through an Electronic Health Intervention in Three Different Countries: Cost-Effectiveness Study in the Do Cardiac Health: Advanced New Generation Ecosystem (Do CHANGE) 2 Randomized Controlled Trial %A Piera-Jiménez,Jordi %A Winters,Marjolein %A Broers,Eva %A Valero-Bover,Damià %A Habibovic,Mirela %A Widdershoven,Jos W M G %A Folkvord,Frans %A Lupiáñez-Villanueva,Francisco %+ Open Evidence Research Group, Universitat Oberta de Catalunya, Rambla del Poblenou, 156, Barcelona, 08018, Spain, 34 651041515, jpieraj@uoc.edu %K cost-effectiveness %K randomized controlled trial %K RCT %K eHealth %K cardiovascular disease %K engagement %K behavior change %K digital health %D 2020 %7 28.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: During the last few decades, preventing the development of cardiovascular disease has become a mainstay for reducing cardiovascular morbidity and mortality. It has been suggested that interventions should focus more on committed approaches of self-care, such as electronic health techniques. Objective: This study aimed to provide evidence to understand the financial consequences of implementing the “Do Cardiac Health: Advanced New Generation Ecosystem” (Do CHANGE 2) intervention, which was evaluated in a multisite randomized controlled trial to change the health behavior of patients with cardiovascular disease. Methods: The cost-effectiveness analysis of the Do CHANGE 2 intervention was performed with the Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing tool, based on a Markov model of five health states. The following two types of costs were considered for both study groups: (1) health care costs (ie, costs associated with the time spent by health care professionals on service provision, including consultations, and associated unplanned hospitalizations, etc) and (2) societal costs (ie, costs attributed to the time spent by patients and informal caregivers on care activities). Results: The Do CHANGE 2 intervention was less costly in Spain (incremental cost was −€2514.90) and more costly in the Netherlands and Taiwan (incremental costs were €1373.59 and €1062.54, respectively). Compared with treatment as usual, the effectiveness of the Do CHANGE 2 program in terms of an increase in quality-adjusted life-year gains was slightly higher in the Netherlands and lower in Spain and Taiwan. Conclusions: In general, we found that the incremental cost-effectiveness ratio strongly varied depending on the country where the intervention was applied. The Do CHANGE 2 intervention showed a positive cost-effectiveness ratio only when implemented in Spain, indicating that it saved financial costs in relation to the effect of the intervention. Trial Registration: ClinicalTrials.gov NCT03178305; https://clinicaltrials.gov/ct2/show/NCT03178305 %M 32720908 %R 10.2196/17351 %U http://www.jmir.org/2020/7/e17351/ %U https://doi.org/10.2196/17351 %U http://www.ncbi.nlm.nih.gov/pubmed/32720908 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 7 %P e19485 %T A Web-Based Intervention to Prevent Multiple Chronic Disease Risk Factors Among Adolescents: Co-Design and User Testing of the Health4Life School-Based Program %A Champion,Katrina Elizabeth %A Gardner,Lauren Anne %A McGowan,Cyanna %A Chapman,Cath %A Thornton,Louise %A Parmenter,Belinda %A McBride,Nyanda %A Lubans,David R %A McCann,Karrah %A Spring,Bonnie %A Teesson,Maree %A , %A Newton,Nicola Clare %+ The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, The Matilda Centre, Level 6, Jane Foss Russell Building (G02), University of Sydney, NSW, Sydney, 2006, Australia, 61 286279006, katrina.champion@sydney.edu.au %K primary prevention %K schools %K eHealth %K chronic disease %K mobile phone %K health promotion %D 2020 %7 28.7.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: Chronic diseases are the leading cause of death worldwide. Addressing key lifestyle risk factors during adolescence is critical for improving physical and mental health outcomes and reducing chronic disease risk. Schools are ideal intervention settings, and electronic health (eHealth) interventions afford several advantages, including increased student engagement, scalability, and sustainability. Although lifestyle risk behaviors tend to co-occur, few school-based eHealth interventions have targeted multiple behaviors concurrently. Objective: This study aims to summarize the co-design and user testing of the Health4Life school-based program, a web-based cartoon intervention developed to concurrently prevent 6 key lifestyle risk factors for chronic disease among secondary school students: alcohol use, smoking, poor diet, physical inactivity, sedentary recreational screen time, and poor sleep (the Big 6). Methods: The development of the Health4Life program was conducted over 18 months in collaboration with students, teachers, and researchers with expertise relevant to the Big 6. The iterative process involved (1) scoping of evidence and systematic literature review; (2) consultation with adolescents (N=815) via a cross-sectional web-based survey to identify knowledge gaps, attitudes, barriers, and facilitators in relation to the Big 6; (3) content and web development; and (4) user testing of the web-based program with students (n=41) and teachers (n=8) to evaluate its acceptability, relevance, and appeal to the target audience. Results: The co-design process resulted in a six-module, evidence-informed program that uses interactive cartoon storylines and web-based delivery to engage students. Student and teacher feedback collected during user testing was positive in terms of acceptability and relevance. Commonly identified areas for improvement concerned the length of modules, age appropriateness of language and alcohol storyline, the need for character backstories and links to syllabus information, and feasibility of implementation. Modifications were made to address these issues. Conclusions: The Health4Life school-based program is the first universal, web-based program to concurrently address 6 important chronic disease risk factors among secondary school students. By adopting a multiple health behavior change approach, it has the potential to efficiently modify the Big 6 risk factors within one program and to equip young people with the skills and knowledge needed to achieve and maintain good physical and mental health throughout adolescence and into adulthood. %M 32720898 %R 10.2196/19485 %U http://formative.jmir.org/2020/7/e19485/ %U https://doi.org/10.2196/19485 %U http://www.ncbi.nlm.nih.gov/pubmed/32720898 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e14915 %T Mobile Mental Health Apps in China: Systematic App Store Search %A Yin,Huifang %A Wardenaar,Klaas J %A Wang,Yuhao %A Wang,Nan %A Chen,Wenjin %A Zhang,Yan %A Xu,Guangming %A Schoevers,Robert A %+ Tianjin Anding Hospital, No 13, Liulin Road, Hexi district, Tianjin, China, 86 15122997716, xugm@ymail.com %K smartphone %K app %K mobile mental health %K mental illness %K mental health problem %K China %D 2020 %7 27.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Smartphones have become ubiquitous in China, offering a promising way to deliver mental health interventions; however, little is known about the current use and characteristics of smartphone apps for mental health. Objective: The purpose of this study was to gain insight into mobile mental health apps available in China as of December 2018. Methods: A systematic search was conducted to identify and evaluate the most downloaded apps from iOS and Android platforms. Apps were categorized according to their main purpose and downloaded to evaluate their content. Each app’s affiliation, cost, target users, information security, and evidence-based nature were evaluated. Results: Of the 172 unique apps that were identified, there were 37 apps (21.5%) for psychological counseling, 50 apps (29.1%) for assessment, 12 apps (7.0%) to relieve stress, 24 apps (14.0%) for psychoeducation, and 49 (28.4%) multipurpose apps (ie, a combination of counseling and assessment). Most apps were developed for adults in the general population (166/172, 96.5%), rather than for psychiatric patients. App-based counseling was mostly provided by psychologists, and of the assessed apps, only 40% (70/172) used evidence-based scales to assess mental health problems such as anxiety or depressed mood. Guided meditation was used as the main technique in stress-relieving apps. Conclusions: Many apps contained useful and evidence-based elements, such as good quality information, validated measurements, and useful meditation methods; however, for mobile apps to contribute significantly to mental health care in China, considerable challenges remain, including the need for more patient-focused apps that can actually take on the role of a health care provider. In addition, efficacy studies are needed. %M 32716301 %R 10.2196/14915 %U https://www.jmir.org/2020/7/e14915 %U https://doi.org/10.2196/14915 %U http://www.ncbi.nlm.nih.gov/pubmed/32716301 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e14223 %T An mHealth Intervention (ReZone) to Help Young People Self-Manage Overwhelming Feelings: Cluster-Randomized Controlled Trial %A Edridge,Chloe %A Wolpert,Miranda %A Deighton,Jessica %A Edbrooke-Childs,Julian %+ Clinical, Educational and Health Psychology, University College London, Gower Street, London, WC1E 6BT, United Kingdom, 44 020 7443 2218, Chloe.edridge@annafreud.org %K cluster trial %K behavioral difficulties %K schools %K mHealth %K digital %K mental health %D 2020 %7 27.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Mental health difficulties in young people are increasing, and there is a need for evidence on the effectiveness of digital interventions to increase opportunities for supporting mental health in young people. Such studies are complicated due to issues of implementation and adoption, outcome measurement, and appropriate study designs. Objective: The objective of this study was to examine the effectiveness of an mHealth intervention (ReZone) in reducing mental health difficulties in young people. Methods: The cluster-randomized controlled trial enrolled 409 participants aged 10-15 years, and classes were allocated to ReZone or management as usual. Self-reported questionnaires were completed at baseline and 3-month follow-up. Results: There were no significant differences between the ReZone condition and management as usual in the self-reported outcome measures. However, there were 3467 usage sessions, which corresponds to 16.9 times per student (total of 205 students) in classes allocated to ReZone. Conclusions: It is essential to publish studies that do not show significant differences, as these findings can still contribute to the literature, help in learning, and inform the direction of future work. The results reported in this paper could be due to a range of reasons, including whether ReZone has the scope to impact change or limitations related to the setting, context, and appropriateness of an RCT. The findings of this study suggest that ReZone was implemented and adopted. International Registered Report Identifier (IRRID): RR2-10.2196/resprot.7019 %M 32716299 %R 10.2196/14223 %U http://www.jmir.org/2020/7/e14223/ %U https://doi.org/10.2196/14223 %U http://www.ncbi.nlm.nih.gov/pubmed/32716299 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e17422 %T Evaluation of a Web-Based Self-Management Program for Patients With Cardiovascular Disease: Explorative Randomized Controlled Trial %A Engelen,Marscha M %A van Dulmen,Sandra %A Puijk-Hekman,Saskia %A Vermeulen,Hester %A Nijhuis-van der Sanden,Maria WG %A Bredie,Sebastian JH %A van Gaal,Betsie GI %+ IQ Healthcare, Radboud Institute for Health Sciences, Radboud university medical center, PO Box 9101, Nijmegen, Netherlands, 31 654272129, marscha.engelen@radboudumc.nl %K explorative randomized controlled trial %K cardiovascular diseases %K self-management %K eHealth support programs %K internet %K lifestyle %K nursing %D 2020 %7 24.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based self-management programs have the potential to support patients with cardiovascular disease (CVD) in their self-management (eg, by focusing on behavior change and improving physical activity). The intervention mapping framework was used to develop a web-based program called Vascular View. The Vascular View program contained 6 modules (coping with CVD, setting boundaries, lifestyle, healthy nutrition, being physically active, interaction with health professionals) aiming to increase self-management behavior by tailoring to the perceived problems and (support) needs of patients after CVD. Objective: The aim was to test the effectiveness of Vascular View before embarking on a full-scale randomized clinical trial (RCT) by evaluating the potential effectiveness and effect sizes of the Vascular View program and identifying outcome measures most likely to capture the potential benefits. Methods: An explorative RCT was performed. Both control and intervention groups received care as usual and, in addition, the intervention group received 12 months of access to a web-based self-management program. Assessment occurred at baseline, 6 months, and 12 months. Outcome measures included general patient-reported outcome measurements: Illness Perception Questionnaire (IPQ), Rand-36, Patient Activation Measure, and patient self-efficacy. Module-specific patient-reported outcome measurements were Beliefs about Medicines Questionnaire, International Physical Activity Questionnaire, Dutch Healthy Diet Index, Fagerström Test for Nicotine Dependence (FTND), Alcohol Use Disorders Identification Test, and Perceived Efficacy in Patient-Physician Interaction. Linear mixed models for repeated measures using intention-to-treat and per-protocol analysis were applied to study differences between the patients in the intervention and control groups. Floor and ceiling effects were explored to give insight into the outcome measures most likely to capture the potential benefits. Results: A total of 105 patients in the control group and 103 patients in the intervention group participated in the study. A positive direction of change between baseline and 12 months was shown for most outcome measurements in favor of the intervention group, of which 2 out of 10 outcomes showed a significant effect: attribution of cause of the disease to risk factors and immunity factors (IPQ) and dependency of nicotine (FTND). Floor and ceiling effects were seen in the IPQ, Rand-36, and the self-efficacy questionnaire. Conclusions: No conclusion for the efficacy of the Vascular View program or selection of outcome measurements can be taken yet. A process evaluation will be conducted to gain thorough insight into the working elements of the program, patient needs in eHealth, and the use of the program by patients. This can determine for whom web-based self-management programs will work and help to adapt the program. Trial Registration: Dutch Trial Register NTR5412; https://www.trialregister.nl/trial/5303 International Registered Report Identifier (IRRID): RR2-10.2196/resprot.6352 %M 32706708 %R 10.2196/17422 %U http://www.jmir.org/2020/7/e17422/ %U https://doi.org/10.2196/17422 %U http://www.ncbi.nlm.nih.gov/pubmed/32706708 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e14861 %T An Internet-Based Psychological Intervention With a Serious Game to Improve Vitality, Psychological and Physical Condition, and Immune Function in Healthy Male Adults: Randomized Controlled Trial %A Schakel,Lemmy %A Veldhuijzen,Dieuwke S %A van Middendorp,Henriët %A Prins,Corine %A Drittij,Anne M H F %A Vrieling,Frank %A Visser,Leo G %A Ottenhoff,Tom H M %A Joosten,Simone A %A Evers,Andrea W M %+ Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Wassenaarseweg 52, Leiden, Netherlands, 31 715273627, a.evers@fsw.leidenuniv.nl %K BCG vaccination %K cognitive behavioral therapy %K immune system %K stress %K ICBT %D 2020 %7 24.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Recently, internet-based cognitive behavioral therapy (ICBT) and serious gaming interventions have been suggested to enhance accessibility to interventions and engagement in psychological interventions that aim to promote health outcomes. Few studies, however, have investigated their effectiveness in the context of simulated real-life challenges. Objective: We aimed to examine the effectivity of a guided ICBT combined with a serious gaming intervention in improving self-reported psychophysiological and immunological health endpoints in response to psychophysiological and immune-related challenges. Methods: Sixty-nine healthy men were randomly assigned to the intervention condition, receiving ICBT combined with serious gaming for 6 weeks, or the control condition, receiving no intervention. Self-reported vitality was the primary endpoint. Other self-reported psychophysiological and immunological endpoints were assessed following various challenges, including a bacillus Calmette-Guérin vaccination evoking pro-inflammatory responses, 1 and 4 weeks after the intervention period. Results: Although the intervention did not affect vitality-associated parameters, self-reported sleep problems (P=.027) and bodily sensations (P=.042) were lower directly after the intervention compared with controls. Furthermore, wellbeing (P=.024) was higher in the intervention group after the psychophysiological challenges. Although no significant group differences were found for the psychophysiological and immunological endpoints, the data provided preliminary support for increased immunoglobulin antibody responses at the follow-up time points (P<.05). Differential chemokine endpoints between conditions were observed at the end of the test day. Conclusions: The present study provides some support for improving health endpoints with an innovative ICBT intervention. Future research should replicate and further extend the present findings by consistently including challenges and a wide range of immune parameters into the study design. Trial Registration: Nederlands Trial Register NTR5610; https://www.trialregister.nl/trial/5466 %M 32706667 %R 10.2196/14861 %U https://www.jmir.org/2020/7/e14861 %U https://doi.org/10.2196/14861 %U http://www.ncbi.nlm.nih.gov/pubmed/32706667 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e17362 %T Implementing Web-Based Therapy in Routine Mental Health Care: Systematic Review of Health Professionals’ Perspectives %A Davies,Fiona %A Shepherd,Heather L %A Beatty,Lisa %A Clark,Brodie %A Butow,Phyllis %A Shaw,Joanne %+ Psycho-Oncology Co-operative Research Group, School of Psychology, The University of Sydney, Lifehouse Level 6-North (C39Z), Sydney, 2006, Australia, 61 2 8627 0828, heather.shepherd@sydney.edu.au %K health professional views %K implementation %K online psychological therapy %K online CBT %K barriers %K facilitators %K models of care %K cognitive behavioral therapy %K internet-based intervention %D 2020 %7 23.7.2020 %9 Review %J J Med Internet Res %G English %X Background: Web-based therapies hold great promise to increase accessibility and reduce costs of delivering mental health care; however, uptake in routine settings has been low. Objective: Our objective in this review was to summarize what is known about health care professionals’ perceptions of the barriers to and facilitators of the implementation of web-based psychological treatments in routine care of adults in health care settings. Methods: We searched 5 major databases (MEDLINE, EMBASE, PsycINFO, CINAHL, and the Cochrane Library) for qualitative, quantitative, or mixed-methods studies exploring health professionals’ views on computer- or internet-based psychological treatment programs. We coded included articles for risk of bias and extracted data using a prepiloted extraction sheet. Results: We identified 29 eligible articles: 14 qualitative, 11 quantitative, and 4 mixed methods. We identified the following themes: patient factors, health professional factors, the therapeutic relationship, therapy factors, organizational and system factors, and models of care. Health professionals supported web-based therapies only for patients with relatively straightforward, low-risk diagnoses, strong motivation and engagement, high computer literacy and access, and low need for tailored content. They perceived flexibility with timing and location as advantages of web-based therapy, but preferred blended therapy to facilitate rapport and allow active monitoring and follow-up of patients. They emphasized the need for targeted training and organizational support to manage changed workflows. Health professionals were concerned about the confidentiality and security of client data for web-based programs, suggesting that clear and transparent protocols need to be in place to reassure health professionals before they will be willing to refer. Conclusions: Without health professionals’ support, many people will not access web-based therapies. To increase uptake, it is important to ensure that health professionals receive education, familiarization, and training to support them in incorporating web-based therapies into their practice, and to design systems that support health professionals in this new way of working with patients and addressing their concerns. Trial Registration: PROSPERO CRD42018100869; https://tinyurl.com/y5vaoqsk %M 32706713 %R 10.2196/17362 %U http://www.jmir.org/2020/7/e17362/ %U https://doi.org/10.2196/17362 %U http://www.ncbi.nlm.nih.gov/pubmed/32706713 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e17207 %T Adherence to Blended or Face-to-Face Smoking Cessation Treatment and Predictors of Adherence: Randomized Controlled Trial %A Siemer,Lutz %A Brusse-Keizer,Marjolein G J %A Postel,Marloes G %A Ben Allouch,Somaya %A Sanderman,Robbert %A Pieterse,Marcel E %+ Technology, Health & Care Research Group, Saxion University of Applied Sciences, MH Tromplaan 28, Enschede, 7513 AB, Netherlands, 31 17678025906, l.siemer@utwente.nl %K blended treatment %K smoking cessation %K adherence %K predictors %K tobacco %K prevention %D 2020 %7 23.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Blended face-to-face and web-based treatment is a promising way to deliver smoking cessation treatment. Since adherence has been shown to be an indicator of treatment acceptability and a determinant for effectiveness, we explored and compared adherence and predictors of adherence to blended and face-to-face alone smoking cessation treatments with similar content and intensity. Objective: The objectives of this study were (1) to compare adherence to a blended smoking cessation treatment with adherence to a face-to-face treatment; (2) to compare adherence within the blended treatment to its face-to-face mode and web mode; and (3) to determine baseline predictors of adherence to both treatments as well as (4) the predictors to both modes of the blended treatment. Methods: We calculated the total duration of treatment exposure for patients (N=292) of a Dutch outpatient smoking cessation clinic who were randomly assigned either to the blended smoking cessation treatment (n=130) or to a face-to-face treatment with identical components (n=162). For both treatments (blended and face-to-face) and for the two modes of delivery within the blended treatment (face-to-face vs web mode), adherence levels (ie, treatment time) were compared and the predictors of adherence were identified within 33 demographic, smoking-related, and health-related patient characteristics. Results: We found no significant difference in adherence between the blended and the face-to-face treatments. Participants in the blended treatment group spent an average of 246 minutes in treatment (median 106.7% of intended treatment time, IQR 150%-355%) and participants in the face-to-face group spent 238 minutes (median 103.3% of intended treatment time, IQR 150%-330%). Within the blended group, adherence to the face-to-face mode was twice as high as that to the web mode. Participants in the blended group spent an average of 198 minutes (SD 120) in face-to-face mode (152% of the intended treatment time) and 75 minutes (SD 53) in web mode (75% of the intended treatment time). Higher age was the only characteristic consistently found to uniquely predict higher adherence in both the blended and face-to-face groups. For the face-to-face group, more social support for smoking cessation was also predictive of higher adherence. The variability in adherence explained by these predictors was rather low (blended R2=0.049; face-to-face R2=0.076). Within the blended group, living without children predicted higher adherence to the face-to-face mode (R2=0.034), independent of age. Higher adherence to the web mode of the blended treatment was predicted by a combination of an extrinsic motivation to quit, a less negative attitude toward quitting, and less health complaints (R2=0.164). Conclusions: This study represents one of the first attempts to thoroughly compare adherence and predictors of adherence of a blended smoking cessation treatment to an equivalent face-to-face treatment. Interestingly, although the overall adherence to both treatments appeared to be high, adherence within the blended treatment was much higher for the face-to-face mode than for the web mode. This supports the idea that in blended treatment, one mode of delivery can compensate for the weaknesses of the other. Higher age was found to be a common predictor of adherence to the treatments. The low variance in adherence predicted by the characteristics examined in this study suggests that other variables such as provider-related health system factors and time-varying patient characteristics should be explored in future research. Trial Registration: Netherlands Trial Register NTR5113; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5113 %M 32459643 %R 10.2196/17207 %U http://www.jmir.org/2020/7/e17207/ %U https://doi.org/10.2196/17207 %U http://www.ncbi.nlm.nih.gov/pubmed/32459643 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e16380 %T Evaluation of a Blended Physical Activity Intervention for Older Adults: Mixed Methods Study %A Mehra,Sumit %A van den Helder,Jantine %A Visser,Bart %A Engelbert,Raoul H H %A Weijs,Peter J M %A Kröse,Ben J A %+ Applied Psychology, Faculty of Applied Social Sciences and Law, Amsterdam University of Applied Sciences, Wibautstraat 3b, Amsterdam, 1091 GH, Netherlands, 31 0621156956, s.mehra@hva.nl %K frail elderly %K aged %K activities of daily living %K exercise %K health behavior %K telemedicine %K mobile devices %K tablet computers %K usability testing %K evaluation %D 2020 %7 23.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Physical activity can prolong the ability of older adults to live independently. Home-based exercises can help achieve the recommended physical activity levels. A blended intervention was developed to support older adults in performing home-based exercises. A tablet and a personal coach were provided to facilitate the self-regulation of exercise behavior. Objective: In line with the Medical Research Council framework, this study aimed to carry out process evaluation of a blended intervention. The objectives were (1) to assess the long-term usability of the tablet adopted in the blended intervention and (2) to explore how the tablet, in conjunction with a personal coach, supported older adults in performing home-based exercises. Methods: The process evaluation was conducted with a mixed-methods approach. At baseline, older adults participating in the blended intervention were asked to fill out a questionnaire about their general experience with information and communication technology (ICT) devices and rate their own skill level. After 6 months, participants filled out the Usefulness, Satisfaction, and Ease of use (USE) questionnaire to assess the usefulness, satisfaction, and ease of use of the tablet. With a random selection of participants, in-depth interviews were held to explore how the tablet and coach supported the self-regulation. The interviews were double coded and analyzed with the directed content analysis method. Results: At baseline, 29% (65/224) of participants who started the intervention (mean age 72 years) filled out the ICT survey and 36% (37/103) of participants who used the tablet for 6 months (mean age 71 years) filled out the USE questionnaire. Furthermore, with 17% (18/103) of participants (mean age 73 years), follow-up interviews were held. The results of the baseline questionnaire showed that the large majority of participants already had experience with a tablet, used it regularly, and reported being skillful in operating ICT devices. After 6 months of use, the participants rated the usefulness, satisfaction, and ease of use of the tablet on average as 3.8, 4.2, and 4.1, respectively, on a 5-point scale. The analysis of the interviews showed that the participants felt that the tablet supported action planning, behavior execution, and self-monitoring. On the other hand, especially during the first few months, the personal coach added value during the goal setting, behavior execution, and evaluation phases of self-regulation. Conclusions: The results of the process evaluation showed that older adults who participated in the study were positive about the blended intervention that was designed to support them in performing home-based exercises. Participants reported that the tablet helped them to perform the exercises better, more frequently, and safely. It supported them in various phases of self-regulation. The availability of a personal coach was nevertheless crucial. To support physical activity in older adults, a blended approach is promising. %M 32459652 %R 10.2196/16380 %U http://www.jmir.org/2020/7/e16380/ %U https://doi.org/10.2196/16380 %U http://www.ncbi.nlm.nih.gov/pubmed/32459652 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e15732 %T Scheduled Telephone Support for Internet Cognitive Behavioral Therapy for Depression in Patients at Risk for Dropout: Pragmatic Randomized Controlled Trial %A Pihlaja,Satu %A Lahti,Jari %A Lipsanen,Jari Olavi %A Ritola,Ville %A Gummerus,Eero-Matti %A Stenberg,Jan-Henry %A Joffe,Grigori %+ Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Hospital District of Helsinki and Uusimaa, PO Box 590, Helsinki, 00029 HUS, Finland, 358 40 513 6500, Grigori.joffe@hus.fi %K internet CBT %K depression %K scheduled telephone support %K adherence %K routine clinical practice %D 2020 %7 23.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Therapist-supported, internet-delivered cognitive behavioral therapy (iCBT) is efficient in the treatment of depression. However, the optimal mode and intensity of therapist support remain to be identified. Scheduled telephone support (STS) may improve adherence and outcomes but, as it is time- and resource-consuming, should be reserved for patients for whom the usual support may be insufficient. Objective: This paper aims to reveal whether add-on STS for patients at risk of dropping out improves treatment adherence and symptoms in iCBT for depression. Methods: Among patients participating in an ongoing large observational routine clinical practice study of iCBT for depression delivered nationwide by Helsinki University Hospital (HUS-iCBT), those demonstrating a ≥14-day delay in initiation of treatment received invitations to this subsidiary STS study. A total of 100 consenting patients were randomly allocated to either HUS-iCBT as usual (control group, n=50) or HUS-iCBT plus add-on STS (intervention group, n=50). Proportions of those reaching midtreatment and treatment end point served as the primary outcome; secondary outcomes were change in Beck Depression Inventory (BDI)–measured depressive symptoms and time spent in treatment. Results: Add-on STS raised the proportion of patients reaching midtreatment compared with HUS-iCBT as usual (29/50, 58% vs 18/50, 36%; P=.045) and treatment end point (12/50, 24% vs 3/50, 6%; P=.02). Change in BDI score also favored add-on STS (3.63 points vs 1.1 points; P=.049), whereas duration of treatment did not differ. Conclusions: Add-on STS enhances adherence and symptom improvement of patients at risk of dropping out of iCBT for depression in routine clinical practice. Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN) 55123131; http://www.isrctn.com/ISRCTN55123131. %M 32706658 %R 10.2196/15732 %U http://www.jmir.org/2020/7/e15732/ %U https://doi.org/10.2196/15732 %U http://www.ncbi.nlm.nih.gov/pubmed/32706658 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e15024 %T Predictors of Self-Determined Module Choice in a Web-Based Computer-Tailored Diet and Physical Activity Intervention: Secondary Analysis of Data From a Randomized Controlled Trial %A Coumans,Juul M J %A Bolman,Catherine A W %A Oenema,Anke %A Lechner,Lilian %+ Department of Health Psychology, Faculty of Psychology, Open University of the Netherlands, Valkenburgerweg 177, Heerlen , Netherlands, 31 45 576 2635, juul.coumans@ou.nl %K eHealth %K computer-tailoring %K self-determination theory %K multiple health behaviors %K lifestyle promotion %K module choice %D 2020 %7 23.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Tailoring an online intervention to participant preferences (eg, by giving participants a choice which modules to follow) may increase engagement in the intervention, motivation for behavioral change, and possibly intervention effects. So far, little is known about what characteristics predict these module choices. Filling this knowledge gap is useful for optimizing program engagement. Objective: We investigated participant choice for a dietary and/or physical activity (PA) promotion module in our web-based computer-tailored intervention based on self-determination theory (SDT) and motivational interviewing (MI). Furthermore, we investigated which demographic characteristics, current behavior, psychosocial constructs and constructs from SDT and MI, and program-related variables such as advice on which module to follow were associated with these choices. Methods: Observational data were used from the randomized controlled trial MyLifestyleCoach of participants who were randomized into the intervention condition, completed the baseline questionnaire, and made a module choice in the opening session of the intervention. Here, they received advice on their own dietary and PA behavior. At the session’s end, they chose which lifestyle modules they would like to follow (both, diet, PA, or no module). Measurements included demographic information; self-reported diet and PA; and several psychosocial, SDT, and MI constructs. In total, data from 619 Dutch adults (59.6% women; mean age was 51.9 [SD 13.5] years) were analyzed. A stepwise multinomial logistic regression analysis was conducted to investigate which characteristics are related to module choice; the diet module served as reference category as almost everyone was advised to follow this module. Results: Of this sample, 54.8% (339/619) chose to do both the diet and PA module, 25.4% (157/619) chose to follow the diet module, 17.8% (110/619) preferred to follow no module, and 2.1% (13/619) chose to do the PA module only. Furthermore, it was found that older people, those who consumed more fruit, and those who scored lower on importance to change their current diet were more likely to choose no module compared to the diet module. People who had more motivation to change their current PA and those who received strong advice compared with slight advice to follow the diet module were more likely to choose both modules compared with the diet module only. Conclusions: The results show that more than half of the sample was interested in following both the diet and PA module in this online lifestyle intervention. Several characteristics were found to be related to module choice. A future challenge is to examine how this knowledge can be used to improve future interventions, such as tailoring (messages or content) on specific groups or examining where and how MI could be used to motivate people to make a certain module choice. Trial Registration: Netherlands Trial Register NL7333; https://www.trialregister.nl/trial/7333 %M 32706659 %R 10.2196/15024 %U http://www.jmir.org/2020/7/e15024/ %U https://doi.org/10.2196/15024 %U http://www.ncbi.nlm.nih.gov/pubmed/32706659 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 7 %P e17712 %T Internet-Based Cognitive-Behavioral Therapy for College Students With Anxiety, Depression, Social Anxiety, or Insomnia: Four Single-Group Longitudinal Studies of Archival Commercial Data and Replication of Employee User Study %A Attridge,Mark D %A Morfitt,Russell C %A Roseborough,David J %A Jones,Edward R %+ Attridge Consulting, Inc, 1129 Cedar Lake Rd S, Minneapolis, MN, United States, 1 612 889 2398, mark@attridgeconsulting.com %K anxiety %K cognitive behavioral %K college %K depression %K insomnia %K mental health %K social phobia %K stress %D 2020 %7 23.7.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: The growing behavioral health needs of college students have resulted in counseling centers reporting difficulties in meeting student demand. Objective: This study aims to test the real-world voluntary use by college students of 4 digital, self-directed mental health modules based on a cognitive behavioral therapy clinical model. The findings were also compared with those of employee users. Methods: Archival operational data from Learn to Live were extracted for student users at 4 colleges and universities in the Midwest region of the United States (N=951). The inclusion criteria were having clinical symptoms at established levels of moderate or higher severity and the use of 2 or more of the 8 lessons of a program within a 6-month period. Unique users in each program included 347 for depression; 325 for stress, anxiety, and worry; 203 for social anxiety; and 76 for insomnia. Paired t tests (two-tailed) compared the average level of change over time on a standardized measure of clinical symptoms appropriate to each program. Cohen d statistical effect sizes were calculated for each program. Potential moderator factors (age, gender, preliminary comprehensive assessment, number of lessons, duration, live coach support, and live teammate support) were tested together in repeated measures analysis of variance models with covariates in the full sample. Follow-up survey data (n=136) were also collected to explore user satisfaction and outcomes. Select data from another study of the same 4 programs by employee users meeting the same criteria (N=707) were examined for comparison. Results: The percentage of users who improved to a clinical status of no longer being at risk after program use was as follows: stress, anxiety, and worry program (149/325, 45.8%); insomnia program (33/76, 43.4%), depression program (124/347, 35.7%); and social anxiety program (45/203, 22.2%). Significant improvements (all P<.001) over time were found in the mean scores for the clinical measures for each program: stress, anxiety, and worry (t324=16.21; d=1.25); insomnia (t75=6.85; d=1.10); depression (t346=12.71; d=0.91); and social anxiety (t202=8.33; d=0.80). Tests of the moderating factors across programs indicated that greater improvement was strongly associated with the use of more lessons and it also differed by program, by gender (males demonstrated more improvement than females), and by the use of live support (particularly coaching). Analyses of survey data found high satisfaction, improved academic outcomes, and successful integration into the university counseling ecosystem. The operational profile and outcomes of the college students were also similar to those of employee users of the same programs from our other study of employee users. Thus, this study provides a replication. Conclusions: Self-directed internet-based cognitive behavioral therapy mental health modules are promising as a supplement to traditional in-person counseling services provided by college counseling centers. %M 32706662 %R 10.2196/17712 %U http://formative.jmir.org/2020/7/e17712/ %U https://doi.org/10.2196/17712 %U http://www.ncbi.nlm.nih.gov/pubmed/32706662 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e18584 %T Novel Stepped Care Approach to Provide Education and Exercise Therapy for Patellofemoral Pain: Feasibility Study %A De Oliveira Silva,Danilo %A Pazzinatto,Marcella F %A Crossley,Kay M %A Azevedo,Fabio M %A Barton,Christian J %+ La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Plenty Road & Kingsbury Drive, Bundoora VIC, Melbourne, 3086, Australia, 61 0426188766, danilo110190@hotmail.com %K pain %K internet %K knee %K rehabilitation %K eHealth %D 2020 %7 22.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Patellofemoral pain (PFP) impairs joint- and health-related quality of life and may be associated with knee osteoarthritis. We developed a novel, 2-phase, stepped-care approach for PFP, combining (1) self-directed web-based education and exercise therapy with (2) physiotherapist-supported education and exercise therapy. Physiotherapy sessions can be provided using 2 different modalities: face-to-face and telerehabilitation. Objective: This study aims to (1) determine the feasibility of our stepped-care approach, (2) explore patient-reported outcomes following self-directed web-based education and exercise therapy in people with PFP (phase 1), and (3) estimate the differences in treatment effects between face-to-face and telerehabilitation to support further education and exercise therapy (phase 2) in those who had not completely recovered following self-directed care. Methods: Phase 1 involved 6 weeks of self-directed web-based education and exercise therapy. Phase 2 involved random allocation to a further 12 weeks of physiotherapist-led (up to 8 sessions) education and exercise therapy delivered face-to-face or via telerehabilitation to participants who did not rate themselves as completely recovered following phase 1. Feasibility indicators of process, adherence, and participant retention were collected as primary outcomes alongside patient-reported outcomes on Global Rating of Change and knee pain, disability, knee-related quality of life, pain catastrophism, kinesiophobia, and knee self-efficacy. All participants were assessed at baseline, 6 weeks, and 18 weeks. Results: A total of 71 participants were screened to identify 35 participants with PFP to enter the study. Overall, 100% (35/35) and 88% (31/35) of the participants were followed up with at 6 and 18 weeks, respectively. In phase 1 of the study, participants accessed the My Knee Cap website for an average of 6 (7.5) days and performed the exercises for an average of 2.5 (3.6) times per week. A total of 20% (7/35) of the participants reported that they had completely recovered at 6 weeks. Furthermore, 93% (26/28) of the participants who were followed up and had not completely recovered at 6 weeks agreed to be enrolled in phase 2. No statistically significant differences were found between the face-to-face and telerehabilitation groups for any outcome. The novel stepped-care approach was associated with marked improvement or complete recovery in 40% (14/35) of the participants following phase 1 and 71% (25/35) of the participants following phase 2. Conclusions: Self-directed web-based education and exercise therapy for people with PFP is feasible, as noted by the high rate of participant retention and home exercise adherence achieved in this study. Furthermore, 20% (7/35) of people reported complete recovery at 6 weeks. Both face-to-face and telerehabilitation physiotherapy should be considered for those continuing to seek care, as there is no difference in outcomes between these delivery modes. Determining the efficacy of the stepped-care model may help guide more efficient health care for PFP. %M 32706674 %R 10.2196/18584 %U http://www.jmir.org/2020/7/e18584/ %U https://doi.org/10.2196/18584 %U http://www.ncbi.nlm.nih.gov/pubmed/32706674 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e13145 %T Internet-Based Self-Management Support After High-Altitude Climate Treatment for Severe Asthma: Randomized Controlled Trial %A Beerthuizen,Thijs %A Rijssenbeek-Nouwens,Lucia H %A van Koppen,Sophia M %A Khusial,Rishi J %A Snoeck-Stroband,Jiska B %A Sont,Jacob K %+ Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands, Leiden, 2300 RC, Netherlands, 31 71 5264578, j.k.sont@lumc.nl %K self-management %K pulmonary rehabilitation %K severe asthma %K quality of life %K asthma control %K internet %K monitoring %D 2020 %7 22.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: In patients with severe asthma, high-altitude climate treatment has been shown to improve asthma control. However, asthma symptoms and limitations may increase after finishing inpatient rehabilitation programs and returning to sea level. Objective: We assessed the effectiveness of a patient-tailored, internet-based, self-management strategy in addition to usual care after finishing high-altitude climate treatment. Methods: We performed a randomized controlled trial with a 1-year follow-up in patients from a high-altitude asthma center in Davos, Switzerland. At the end of a 12-week multidisciplinary rehabilitation program, 62 adults with asthma were randomized to receive either internet-based self-management support in addition to usual care (n=33) or usual care only after discharge (n=29). The endpoints were changes in asthma-related quality of life according to the Asthma Quality of Life Questionnaire (AQLQ) (a higher score is better) and asthma control according to the Asthma Control Questionnaire (ACQ) (a lower score is better), with a minimally important difference of 0.5 points for both. Results: Asthma-related quality of life and asthma control declined over time in the usual care strategy group, whereas there was a slower decline in the internet-based strategy group. For both endpoints, mixed-model analysis showed a significant positive effect in favor of internet-based self-management during follow-up (mean AQLQ score difference 0.39, 95% CI 0.092-0.69; P=.01 and ACQ score difference −0.50, 95% CI −0.86 to −0.15; P=.006), which was prominent among patients with uncontrolled asthma at discharge (AQLQ score difference 0.59, 95% CI 0.19-0.99; P=.003 and ACQ score difference −0.73, 95% CI −1.18 to −0.28; P=.002). Conclusions: Internet-based self-management support was associated with a smaller decline in quality of life and asthma control as compared with usual care, especially in patients with lower asthma control, after completion of high-altitude climate treatment. Internet-based self-management support in adults with severe asthma seems feasible and effective to maintain quality of life and asthma control. Trial Registration: The trial is registered in the Netherlands Trial Register (NTR1995). %M 32706692 %R 10.2196/13145 %U https://www.jmir.org/2020/7/e13145 %U https://doi.org/10.2196/13145 %U http://www.ncbi.nlm.nih.gov/pubmed/32706692 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 7 %P e15576 %T Effectiveness of Wearable Trackers on Physical Activity in Healthy Adults: Systematic Review and Meta-Analysis of Randomized Controlled Trials %A Tang,Matilda Swee Sun %A Moore,Katherine %A McGavigan,Andrew %A Clark,Robyn A %A Ganesan,Anand N %+ College of Medicine and Public Health, Flinders University, Level 5, Room 5E209 Flinders Medical Centre, Adelaide, Australia, 61 (08) 7221 8200, anand.ganesan@flinders.edu.au %K wearable activity tracker %K physical activity %K healthy adults %K randomized controlled trials %D 2020 %7 22.7.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Wearable trackers are an increasingly popular tool among healthy adults and are used to facilitate self-monitoring of physical activity. Objective: We aimed to systematically review the effectiveness of wearable trackers for improving physical activity and weight reduction among healthy adults. Methods: This review used the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methodology and reporting criteria. English-language randomized controlled trials with more than 20 participants from MEDLINE, CINAHL, Cochrane Library, Web of Science, PubMed, and Scopus (2000-2017) were identified. Studies were eligible for inclusion if they reported an intervention group using wearable trackers, reporting steps per day, total moderate-to-vigorous physical activity, activity, physical activity, energy expenditure, and weight reduction. Results: Twelve eligible studies with a total of 1693 participants met the inclusion criteria. The weighted average age was 40.7 years (95% CI 31.1-50.3), with 64.4% women. The mean intervention duration was 21.4 weeks (95% CI 6.1-36.7). The usage of wearable trackers was associated with increased physical activity (standardized mean difference 0.449, 95% CI 0.10-0.80; P=.01). In the subgroup analyses, however, wearable trackers demonstrated no clear benefit for physical activity or weight reduction. Conclusions: These data suggest that the use of wearable trackers in healthy adults may be associated with modest short-term increases in physical activity. Further data are required to determine if a sustained benefit is associated with wearable tracker usage. %M 32706685 %R 10.2196/15576 %U http://mhealth.jmir.org/2020/7/e15576/ %U https://doi.org/10.2196/15576 %U http://www.ncbi.nlm.nih.gov/pubmed/32706685 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e15591 %T Implementation Strategies for Web-Based Apps for Screening: Scoping Review %A Ooi,Chor Yau %A Ng,Chirk Jenn %A Sales,Anne E %A Lim,Hooi Min %+ University of Malaya eHealth Initiative, Department of Primary Care Medicine, Faculty of Medicine, University of Malaya, , Kuala Lumpur, , Malaysia, 60 79492306, ngcj@um.edu.my %K internet %K mHealth %K eHealth %K mass screening %K implementation strategies %D 2020 %7 20.7.2020 %9 Review %J J Med Internet Res %G English %X Background: Screening is an effective primary prevention strategy in health care, as it enables the early detection of diseases. However, the uptake of such screening remains low. Different delivery methods for screening have been developed and found to be effective in increasing the uptake of screening, including the use of web-based apps. Studies have shown that web-based apps for screening are effective in increasing the uptake of health screening among the general population. However, not much is known about the effective implementation of such web-based apps in the real-world setting. Implementation strategies are theory-based methods or techniques used to enhance the adoption, implementation, and sustainability of evidence-based interventions. Implementation strategies are important, as they allow us to understand how to implement an evidence-based intervention. Therefore, a scoping review to identify the various implementation strategies for web-based apps for screening is warranted. Objective: This scoping review aims to identify (1) strategies used to implement web-based apps for health screening, (2) frameworks used for implementing web-based apps for health screening, (3) outcome measures of implementation strategies, and (4) effective implementation strategies. Methods: This scoping review was conducted based on Arksey and O’Malley’s framework. After identifying the review question, two researchers independently screened and selected relevant literature from PubMed, Embase, Cochrane, Cumulative Index of Nursing and Allied Health Literature, PsycINFO, International Standard Randomised Controlled Trial Number Registry, OpenGrey, ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform, and Web of Science. This was followed by charting the data using a standardized form. Finally, we collated, summarized, and reported the results quantitatively and qualitatively based on the review objectives. Results: A total of 16,476 studies were retrieved, of which 5669 were duplicates. From a total of 10,807 studies, 10,784 studies were excluded based on their titles and abstracts. There were 23 full-text articles reviewed, and 4 articles were included in the final analysis. Many studies were excluded because they focused on the effectiveness and not on the implementation of web-based apps. Facilitation was the most cited implementation strategy used, followed by reminders, clinical champions, and educational meetings and materials. Only 2 studies used implementation frameworks to guide the evaluation of their studies. Common outcome measures for implementation strategies were feasibility, fidelity, and penetration. Implementation strategies reported to be effective were quality improvement meetings, facilitation, educational meetings, and clinical champions. Conclusions: There is a dearth of literature on the implementation of web-based apps for health screening. Implementation strategies were developed without any reported use of implementation theories or frameworks in most studies. More research on the development and evaluation of web-based screening app implementations is needed. %M 32706655 %R 10.2196/15591 %U http://www.jmir.org/2020/7/e15591/ %U https://doi.org/10.2196/15591 %U http://www.ncbi.nlm.nih.gov/pubmed/32706655 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 7 %N 7 %P e15797 %T The Effect of Shame on Patients With Social Anxiety Disorder in Internet-Based Cognitive Behavioral Therapy: Randomized Controlled Trial %A Wang,Haoyu %A Zhao,Qingxue %A Mu,Wenting %A Rodriguez,Marcus %A Qian,Mingyi %A Berger,Thomas %+ School of Psychological and Cognitive Sciences, Peking University, The Philosophical Building 2nd Fl., Yiheyuan Road, Haidian District, Beijing, China, 86 62761081, qmy@pku.edu.cn %K internet-based intervention %K cognitive behavioral therapy %K phobia %K social %K shame %K implosive therapy %D 2020 %7 20.7.2020 %9 Original Paper %J JMIR Ment Health %G English %X Background: Prior research has demonstrated the efficacy of internet-based cognitive behavioral therapy (ICBT) for social anxiety disorder (SAD). However, it is unclear how shame influences the efficacy of this treatment. Objective: This study aimed to investigate the role shame played in the ICBT treatment process for participants with SAD. Methods: A total of 104 Chinese participants (73 females; age: mean 24.92, SD 4.59 years) were randomly assigned to self-help ICBT, guided ICBT, or wait list control groups. For the guided ICBT group, half of the participants were assigned to the group at a time due to resource constraints. This led to a time difference among the three groups. Participants were assessed before and immediately after the intervention using the Social Interaction Anxiety Scale (SIAS), Social Phobia Scale (SPS), and Experience of Shame Scale (ESS). Results: Participants’ social anxiety symptoms (self-help: differences between pre- and posttreatment SIAS=−12.71; Cohen d=1.01; 95% CI 9.08 to 16.32; P<.001 and differences between pre- and posttreatment SPS=11.13; Cohen d=0.89; 95% CI 6.98 to 15.28; P<.001; guided: SIAS=19.45; Cohen d=1.20; 95% CI 14.67 to 24.24; P<.001 and SPS=13.45; Cohen d=0.96; 95% CI 8.26 to 18.64; P<.001) and shame proneness (self-help: differences between pre- and posttreatment ESS=7.34; Cohen d=0.75; 95% CI 3.99 to 10.69; P<.001 and guided: differences between pre- and posttreatment ESS=9.97; Cohen d=0.88; 95% CI 5.36 to 14.57; P<.001) in both the self-help and guided ICBT groups reduced significantly after treatment, with no significant differences between the two intervention groups. Across all the ICBT sessions, the only significant predictors of reductions in shame proneness were the average number of words participants wrote in the exposure module (β=.222; SE 0.175; t96=2.317; P=.02) and gender (β=−.33; SE 0.002; t77=−3.13; P=.002). We also found a mediation effect, wherein reductions in shame fully mediated the relationship between the average number of words participants wrote in the exposure module and reductions in social anxiety symptoms (SIAS: β=−.0049; SE 0.0016; 95% CI −0.0085 to −0.0019 and SPS: β=−.0039; SE 0.0015; 95% CI −0.0075 to −0.0012). Conclusions: The findings of this study suggest that participants’ engagement in the exposure module in ICBT alleviates social anxiety symptoms by reducing the levels of shame proneness. Our study provides a new perspective for understanding the role of shame in the treatment of social anxiety. The possible mechanisms of the mediation effect and clinical implications are discussed. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900021952; http://www.chictr.org.cn/showproj.aspx?proj=36977 %M 32347799 %R 10.2196/15797 %U https://mental.jmir.org/2020/7/e15797 %U https://doi.org/10.2196/15797 %U http://www.ncbi.nlm.nih.gov/pubmed/32347799 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e14822 %T Dose-Response Relationship of a Web-Based Tailored Intervention Promoting Human Papillomavirus Vaccination: Process Evaluation of a Randomized Controlled Trial %A Pot,Mirjam %A Paulussen,Theo GWM %A Ruiter,Robert AC %A Mollema,Liesbeth %A Hofstra,Miranda %A Van Keulen,Hilde M %+ Child Health, Netherlands Organization for Applied Scientific Research (TNO), Schipholweg 77, Leiden, 2316ZL, Netherlands, 31 643234293, mirjampot90@gmail.com %K HPV vaccination %K web-based tailored intervention %K process evaluation %K intervention use %K dose-response relationship %K randomized controlled trial %K informed decision making %D 2020 %7 17.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: In the Netherlands, human papillomavirus (HPV) vaccination uptake remains low. To improve informed decision making (IDM) and HPV vaccination acceptability, we systematically developed an interactive, web-based tailored intervention to which mothers of Dutch girls were invited to participate. Objective: The aim of this study was to provide insight into the intervention’s working mechanisms by evaluating (1) program use, (2) program acceptability, and (3) the relationship of program use with program acceptability and intervention effects (ie, dose-response relationship). Methods: Only mothers from the intervention arm of a randomized controlled trial that assessed the effectiveness of the web-based, tailored intervention were included in this study. They were invited to visit the website of the web-based intervention between baseline (January 2015, just before access to the intervention) and follow up (March 2015, prior to the first HPV vaccination). Indicators for program use were time of website use (ie, duration of intervention exposure) and completeness (ie, proportion of all available web pages visited). HPV vaccination uptake registered by Praeventis was used as the primary outcome. Secondary outcomes were IDM, decisional conflict, and social-psychological determinants of HPV vaccination uptake. Results: Among the 3995 invited mothers, 2509 (62.80%) logged on to the website, 2239 of whom (89.24%) visited at least one page of the intervention components. On average, mothers spent 21.39 minutes (SD 12.41) on the website and completed 50.04% (SD 26.18%) of the website components. Participants rated the website 7.64 (SD 1.39) on a 10-point scale. Program acceptability was significantly associated with completeness (β=4.36, P<.001), but not with time of website use (β=–.07, P=.77). Intention-to-treat analysis (N=3995) showed a significant positive effect of completeness on all outcome measures (all P<.003; Bonferroni-corrected α=.05/15 factors), including on HPV vaccination uptake. Time of website use had a significant positive effect on all outcomes (all P<.003), except for uptake (P=.20), risk perception when not vaccinated (P=.14), subjective norms (P=.03), and habit (P=.01). Conclusions: Program use and acceptability of the intervention were adequate. Completeness was positively associated with acceptability. Furthermore, positive effects (ie, dose-response effects) were found for completeness and time of website use on the mothers’ IDM, decisional conflict, and almost all of the social-psychological determinants of HPV vaccination acceptability. In addition, the extent to which mothers completed the intervention had a positive impact on their daughters’ vaccination uptake. This indicates that the web-based, tailored intervention fits well with the mothers’ needs, and that completeness of use is essential for improving HPV vaccination uptake, acceptability, and IDM. Program use should therefore be promoted. Trial Registration: Netherlands Trial Register NTR4795; https://www.trialregister.nl/trial/4795 %M 32520718 %R 10.2196/14822 %U https://www.jmir.org/2020/7/e14822 %U https://doi.org/10.2196/14822 %U http://www.ncbi.nlm.nih.gov/pubmed/32520718 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 7 %N 7 %P e18595 %T Effectiveness of an 8-Week Web-Based Mindfulness Virtual Community Intervention for University Students on Symptoms of Stress, Anxiety, and Depression: Randomized Controlled Trial %A El Morr,Christo %A Ritvo,Paul %A Ahmad,Farah %A Moineddin,Rahim %A , %+ School of Health Policy and Management, York University, 4700 Keele St. Stong #350, Toronto, ON, M3J 1P3, Canada, 1 4167362100 ext 22053, elmorr@yorku.ca %K virtual community %K virtual care %K mindfulness %K depression %K anxiety %K stress %K students %K online %K randomized controlled trial %K Canada %D 2020 %7 17.7.2020 %9 Original Paper %J JMIR Ment Health %G English %X Background: A student mental health crisis is increasingly acknowledged and will only intensify with the COVID-19 crisis. Given accessibility of methods with demonstrated efficacy in reducing depression and anxiety (eg, mindfulness meditation and cognitive behavioral therapy [CBT]) and limitations imposed by geographic obstructions and localized expertise, web-based alternatives have become vehicles for scaled-up delivery of benefits at modest cost. Mindfulness Virtual Community (MVC), a web-based program informed by CBT constructs and featuring online videos, discussion forums, and videoconferencing, was developed to target depression, anxiety, and experiences of excess stress among university students. Objective: The aim of this study was to assess the effectiveness of an 8-week web-based mindfulness and CBT program in reducing symptoms of depression, anxiety, and stress (primary outcomes) and increasing mindfulness (secondary outcome) within a randomized controlled trial (RCT) with undergraduate students at a large Canadian university. Methods: An RCT was designed to assess undergraduate students (n=160) who were randomly allocated to a web-based guided mindfulness–CBT condition (n=80) or to a waitlist control (WLC) condition (n=80). The 8-week intervention consisted of a web-based platform comprising (1) 12 video-based modules with psychoeducation on students’ preidentified life challenges and applied mindfulness practice; (2) anonymous peer-to-peer discussion forums; and (3) anonymous, group-based, professionally guided 20-minute live videoconferences. The outcomes (depression, anxiety, stress, and mindfulness) were measured via an online survey at baseline and at 8 weeks postintervention using the Patient Health Questionnaire-9 (PHQ9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF). Analyses employed generalized estimation equation methods with AR(1) covariance structures and were adjusted for possible covariates (gender, age, country of birth, ethnicity, English as first language, paid work, unpaid work, relationship status, physical exercise, self-rated health, and access to private mental health counseling). Results: Of the 159 students who provided T1 data, 32 were males and 125 were females with a mean age of 22.55 years. Participants in the MVC (n=79) and WLC (n=80) groups were similar in sociodemographic characteristics at T1 with the exception of gender and weekly hours of unpaid volunteer work. At postintervention follow-up, according to the adjusted comparisons, there were statistically significant between-group reductions in depression scores (β=–2.21, P=.01) and anxiety scores (β=–4.82, P=.006), and a significant increase in mindfulness scores (β=4.84, P=.02) compared with the WLC group. There were no statistically significant differences in perceived stress for MVC (β=.64, P=.48) compared with WLC. Conclusions: With the MVC intervention, there were significantly reduced depression and anxiety symptoms but no significant effect on perceived stress. Online mindfulness interventions can be effective in addressing common mental health conditions among postsecondary populations on a large scale, simultaneously reducing the current burden on traditional counseling services. Trial Registration: ISRCTN Registry ISRCTN12249616; http://www.isrctn.com/ISRCTN12249616 %M 32554380 %R 10.2196/18595 %U http://mental.jmir.org/2020/7/e18595/ %U https://doi.org/10.2196/18595 %U http://www.ncbi.nlm.nih.gov/pubmed/32554380 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e16136 %T Adherence to Established Treatment Guidelines Among Unguided Digital Interventions for Depression: Quality Evaluation of 28 Web-Based Programs and Mobile Apps %A Bubolz,Stefan %A Mayer,Gwendolyn %A Gronewold,Nadine %A Hilbel,Thomas %A Schultz,Jobst-Hendrik %+ Department of General Internal Medicine and Psychosomatics, Heidelberg University Hospital, Im Neuenheimer Feld 130.3, Heidelberg, 69120, Germany, 49 6221 56 38176, nadine.gronewold@med.uni-heidelberg.de %K web-based interventions %K depression %K mHealth %K mental health %K telemedicine %K mobile phone %K eHealth %K electronic mental health %K online therapy %D 2020 %7 13.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based interventions for depression have been widely tested for usability and functioning. However, the few studies that have addressed the therapeutic quality of these interventions have mainly focused on general aspects without consideration of specific quality factors related to particular treatment components. Clinicians and scientists are calling for standardized assessment criteria for web-based interventions to enable effective and trustworthy patient care. Therefore, an extensive evaluation of web-based interventions at the level of individual treatment components based on therapeutic guidelines and manuals is needed. Objective: The objective of this study was to evaluate the quality of unguided web-based interventions for depression at the level of individual treatment components based on their adherence to current gold-standard treatment guidelines and manuals. Methods: A comprehensive online search of popular app stores and search engines in January 2018 revealed 11 desktop programs and 17 smartphone apps that met the inclusion criteria. Programs and apps were included if they were available for German users, interactive, unguided, and targeted toward depression. All programs and apps were tested by three independent researchers following a standardized procedure with a predefined symptom trajectory. During the testing, all web-based interventions were rated with a standardized list of criteria based on treatment guidelines and manuals for depression. Results: Overall interrater reliability for all raters was substantial with an intraclass correlation coefficient of 0.73 and Gwet AC1 value of 0.80. The main features of web-based interventions included mood tracking (24/28, 86%), psychoeducation (21/28, 75%), cognitive restructuring (21/28, 75%), crisis management (20/28, 71%), behavioral activation (19/29, 68%), and relaxation training (18/28, 64%). Overall, therapeutic meaningfulness was rated higher for desktop programs (mean 4.13, SD 1.17) than for smartphone apps (mean 2.92, SD 1.46). Conclusions: Although many exercises from manuals are included in web-based interventions, the necessary therapeutic depth of the interventions is often not reached, and risk management is frequently lacking. There is a need for further research targeting general principles for the development and evaluation of therapeutically sound web-based interventions for depression. %M 32673221 %R 10.2196/16136 %U https://www.jmir.org/2020/7/e16136 %U https://doi.org/10.2196/16136 %U http://www.ncbi.nlm.nih.gov/pubmed/32673221 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 6 %N 3 %P e16083 %T Changes in Health-Risk Behavior, Body Mass Index, Mental Well-Being, and Risk Status Following Participation in a Stepwise Web-Based and Face-to-Face Intervention for Prevention of Lifestyle-Related Diseases: Nonrandomized Follow-Up Cohort Study %A Thilsing,Trine %A Sonderlund,Anders Larrabee %A Sondergaard,Jens %A Svensson,Nanna Herning %A Christensen,Jeanette Reffstrup %A Thomsen,Janus Laust %A Hvidt,Niels Christian %A Larsen,Lars Bruun %+ Research Unit of General Practice, Department of Public Health, University of Southern Denmark, JB Winsloews Vej 9A, Odense, Denmark, 45 65 50 71 95, tthilsing@health.sdu.dk %K health behavior %K noncommunicable diseases %K lifestyle-related disease %K prevention %K patient web portal %K primary health care %K risk reduction behavior %D 2020 %7 9.7.2020 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: Recent evidence suggests the effectiveness of stepwise, targeted approaches for the prevention of lifestyle-related diseases with combinations of web-based and face-to-face interventions showing promising results. Objective: This paper reports on 1-year changes in health-risk behaviors, BMI, self-rated health, mental well-being, and risk of disease at 1-year follow-up after participation in a stepwise intervention that targeted persons at high risk of disease and persons with health-risk behavior. To this end, we distinguish between participants who took up the full intervention (web-based plus face-to-face) and those who received only the web-based intervention. Methods: The Early Detection and Prevention (Danish acronym: TOF) pilot study was conducted as a nonrandomized, 1-year follow-up intervention study in two municipalities in the Region of Southern Denmark. A total of 9400 citizens born between 1957 and 1986 (aged 29 to 60 years) were randomly sampled from participating general practitioner (GP) patient-list systems and were invited to take part in the study. Participants were subsequently stratified into risk groups based on their responses to a questionnaire on health-risk behavior and data from their GP’s electronic patient record (EPR) system. All participants received a digital personal health profile with individualized information on current health-risk behavior and targeted advice on relevant health-risk behavior changes. In addition, patients at high risk of disease, as indicated by their digital health profile, were offered a targeted intervention at their GP. Patients who were not deemed at high risk of disease but who exhibited health-risk behaviors were offered a targeted intervention at their municipal health center (MHC). At 1-year follow-up, health-risk behaviors, self-rated health, BMI, and mental well-being were reassessed by questionnaire, and current information on diagnoses and medical treatment was retrieved from the EPRs. Results: Of 598 patients at high risk of disease or with health-risk behavior, 135 took up the targeted intervention at their GP or MHC and 463 received the personal health profile only. From baseline to 1-year follow-up, the number of patients with unhealthy eating habits decreased, mean mental well-being increased, and smoking prevalence decreased in patients who had received the digital personal health profile alone. Among patients who took up the targeted intervention, unhealthy eating habits and sedentary lifestyles decreased and significant reductions in mean BMI were observed. At 1-year follow up, no health-risk behaviors were detected among 17.4% of patients who at baseline had exhibited health-risk behaviors or high risk of disease. Conclusions: A stepwise targeted preventive approach using web-based and face-to-face elements may lead to favorable lifestyle changes. Specifically, a web-based approach may improve smoking and eating habits and mental well-being, whereas supplementary face-to-face interventions may be necessary to improve exercise habits and BMI. Trial Registration: ClinicalTrials.gov NCT02797392; https://clinicaltrials.gov/ct2/show/NCT02797392 International Registered Report Identifier (IRRID): RR2-10.1186/s12875-018-0820-8 %M 32673269 %R 10.2196/16083 %U https://publichealth.jmir.org/2020/3/e16083 %U https://doi.org/10.2196/16083 %U http://www.ncbi.nlm.nih.gov/pubmed/32673269 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e19734 %T Use of an Unguided, Web-Based Distress Self-Management Program After Breast Cancer Diagnosis: Sub-Analysis of CaringGuidance Pilot Study %A Lally,Robin M %A Kupzyk,Kevin %A Gallo,Steve %A Berry,Donna %+ College of Nursing, Fred & Pamela Buffett Cancer Center, University of Nebraska Medical Center, UNMC College of Nursing Center For Nursing Science, 985330 Nebraska Medical Center, Omaha, NE, 68198-0001, United States, 1 4025595464, robin.lally@unmc.edu %K eHealth %K psychoeducation %K supportive oncology %K distress %K self-management %K oncology %K breast cancer %D 2020 %7 6.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Unguided, web-based psychoeducational interventions are gaining interest as a way to reach patients while reducing pressure on clinical resources. However, there has been little research on how patients with cancer use these interventions. Objective: The objective of this analysis was to evaluate how women newly diagnosed with breast cancer used the unguided web-based, psychoeducational distress self-management program CaringGuidance After Breast Cancer Diagnosis while enrolled in a pilot feasibility study. Methods: Women with stage 0 to II breast cancer diagnosed within the prior three months were recruited from clinics primarily in the Northeastern United States for participation in a 12-week pilot study of CaringGuidance plus usual care versus usual care alone. Usage prompts included sets of emails sent weekly for 12 weeks; standardized congratulatory emails after every two hours of program use, and informative emails for each cognitive-behavioral exercise. Individual user activity on the site was automatically tracked by an analytics system and recorded directly in the CaringGuidance database. Results: Complete usage data were available for 54 subjects. Ninety-eight percent of the intervention group logged into CaringGuidance independently at least once. Thirty-eight (70%) logged in during all three months, 15 (28%) were intermittent users, and one (2%) was a non-user. Users (n=53) averaged 15.6 (SD 9.85) logins. Mean logins were greatest in month 1 (7.26, SD 4.02) and declined in months 2 (4.32, SD 3.66) and month 3 (4.02, SD 3.82). Eleven (21%) used CaringGuidance with both the frequency and activity level intended at study outset, 9 (17%) exceeded intended frequency and activity (high-high users), and 10 (19%) were below expected usage on both login frequency and activity (low-low users). Low-low users and high-high users differed significantly (P<.001) in the total number of views and unique views of all program components. Change in depressive symptoms and the number of sessions (r=.351) and logins (r=.348) between study months 1 and 2 were significantly correlated (P=.018, .019). Higher baseline distress was associated with more unique views of program resources (r=.281, P=.043). Change in intrusive/avoidant thoughts from baseline to month 3, and the number of users’ unique exercise views were negatively correlated (r=–.319, P=.035) so that more unique exercise views, equated with greater decline in intrusive/avoidant thoughts from baseline to month 3. Conclusions: These findings favor the hypothesis that the key ingredient is not the amount of program use, but each user’s self-selected activity within the program. More research is needed on the ideal ways to maintain use, and capture and define engagement and enactment of behaviors by people with cancer accessing unguided, self-management web-based programs. %M 32628117 %R 10.2196/19734 %U https://www.jmir.org/2020/7/e19734 %U https://doi.org/10.2196/19734 %U http://www.ncbi.nlm.nih.gov/pubmed/32628117 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 7 %N 6 %P e20513 %T Acceptability and Utility of an Open-Access, Online Single-Session Intervention Platform for Adolescent Mental Health %A Schleider,Jessica Lee %A Dobias,Mallory %A Sung,Jenna %A Mumper,Emma %A Mullarkey,Michael C %+ Department of Psychology, Stony Brook University, Psychology-B 340, Stony Brook, NY, 11794-2500, United States, 1 9174391872, jessica.schleider@stonybrook.edu %K internet intervention %K online interventions %K youth %K mental health %K adolescent %K depression %K single-session intervention %K intervention %D 2020 %7 30.6.2020 %9 Original Paper %J JMIR Ment Health %G English %X Background: Many youths with mental health needs are unable to access care. Single-session interventions (SSIs) have helped reduce youth psychopathology across multiple trials, promising to broaden access to effective, low-intensity supports. Online, self-guided SSIs may be uniquely scalable, particularly if they are freely available for as-needed use. However, the acceptability of online SSI and their efficacy have remained unexamined outside of controlled trials, and their practical utility is poorly understood. Objective: We evaluated the perceived acceptability and proximal effects of Project YES (Youth Empowerment & Support), an open-access platform offering three online SSIs for youth internalizing distress. Methods: After selecting one of three SSIs to complete, participants (ages 11-17 years) reported pre- and post-SSI levels of clinically relevant outcomes that SSIs may target (eg, hopelessness, self-hate) and perceived SSI acceptability. User-pattern variables, demographics, and depressive symptoms were collected to characterize youths engaging with YES. Results: From September 2019 through March 2020, 694 youths accessed YES, 539 began, and 187 completed a 30-minute, self-guided SSI. SSI completers reported clinically elevated depressive symptoms, on average, and were diverse on several dimensions (53.75% non-white; 78.10% female; 43.23% sexual minorities). Regardless of SSI selection, completers reported pre- to post-program reductions in hopelessness (dav=0.53; dz=0.71), self-hate (dav=0.32; dz=0.61), perceived control (dav=0.60; dz=0.72) and agency (dav=0.39; dz=0.50). Youths rated all SSIs as acceptable (eg, enjoyable, likely to help peers). Conclusions: Results support the perceived acceptability and utility of open-access, free-of-charge SSIs for youth experiencing internalizing distress. Trial Registration: Open Science Framework; osf.io/e52p3 %M 32602846 %R 10.2196/20513 %U http://mental.jmir.org/2020/6/e20513/ %U https://doi.org/10.2196/20513 %U http://www.ncbi.nlm.nih.gov/pubmed/32602846 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 6 %P e17845 %T Evaluating Engagement in a Digital and Dietetic Intervention Promoting Healthy Weight Gain in Pregnancy: Mixed Methods Study %A Willcox,Jane C %A Chai,Daniel %A Beilin,Lawrence J %A Prescott,Susan L %A Silva,Desiree %A Neppe,Cliff %A Huang,Rae-Chi %+ Telethon Kids Institute, Hospital Avenue, Nedlands, Perth, 6009, Australia, 61 0402131555, rae-chi.huang@telethonkids.org.au %K pregnancy %K internet-based intervention %K patient participation %K qualitative research %K eHealth %K body weight %K obesity %D 2020 %7 26.6.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Early excess and inadequate gestational weight gain (GWG) have been associated with negative outcomes for mother and child. The use of digital media to deliver pregnancy lifestyle interventions is increasing, but there is little data on participant engagement. The Pregnancy Lifestyle Activity and Nutrition (PLAN) intervention pilot study was an electronic health and dietetic-delivered intervention program promoting healthy GWG in early pregnancy. Objective: This study aims to explore the interactions of participants with the program and to assess its acceptability. Methods: This study uses both quantitative and qualitative methods using data from parent randomized controlled trial (ACTRN12617000725369). Quantitative data from 22 participants in the intervention arm who completed the study provided measures of the interactions participants had with the digital components of the program and with dietetic consultations. A descriptive qualitative analysis employed semistructured interviews with 9 participants to elicit views on the acceptability of the intervention and its components. Results: The electronic delivery of information and recording of weight from 8 to 20 weeks of gestation were universally accepted. Component (face-to-face dietitian, weight tracker, website information delivery, and SMS goal prompting) acceptability and engagement differed between individuals. A total of 4 key themes emerged from the qualitative analysis: supporting lifestyle change, component acceptability and value, delivery platforms, and engagement barriers. Conclusions: The PLAN intervention and its delivery via a blend of personal dietetic consultations and digital program delivery was found to be acceptable and valuable to pregnant women. Individuals responded differently to various components, emphasizing the importance of including women in the development of lifestyle interventions and allowing participants to choose and tailor programs. Larger randomized controlled trials using these insights in a broader section of the community are needed to inform the iterative development of practical, time-efficient, and cost-effective ways of supporting optimal GWG with the potential to optimize outcomes for pregnant women and their child. %M 32442153 %R 10.2196/17845 %U http://www.jmir.org/2020/6/e17845/ %U https://doi.org/10.2196/17845 %U http://www.ncbi.nlm.nih.gov/pubmed/32442153 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 6 %P e17570 %T Young People’s Experience of a Long-Term Social Media–Based Intervention for First-Episode Psychosis: Qualitative Analysis %A Valentine,Lee %A McEnery,Carla %A O’Sullivan,Shaunagh %A Gleeson,John %A Bendall,Sarah %A Alvarez-Jimenez,Mario %+ Orygen, 35 Poplar Rd, Parkville, 3052, Australia, 61 0417398175, lee.valentine@orygen.org.au %K social media %K social networking %K youth %K young adult %K psychotic disorders %K mHealth %K qualitative research %D 2020 %7 26.6.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital mental health interventions present a unique opportunity to address the lack of social connection and loneliness experienced by young people with first-episode psychosis (FEP). The first generation of digital interventions, however, is associated with high attrition rates. Social media presents an opportunity to target this issue. A new generation of digital intervention has harnessed the popularity of social media to both promote engagement and foster social connectedness in youth mental health interventions. Despite their potential, little is known about how young people engage with, and experience, social media–based interventions as well as the optimal design, implementation, and management needed to ensure young people with psychosis receive benefit. Objective: This study aimed to explore how young people engage with, and experience, a long-term social media–based mental health intervention designed to address social functioning in individuals with FEP. Methods: This qualitative study was based on 12 interviews with young people who used Horyzons, a long-term social media–based mental health intervention, as part of a previous randomized controlled trial. A semistructured phenomenological interview guide with open-ended questions was used to explore young people’s subjective experience of the intervention. All interviews were recorded and transcribed verbatim. Data were analyzed using interpretative phenomenological analysis. Results: A total of 4 superordinate themes emerged during the analysis including (1) shared experience as the catalyst for a cocreated social space, (2) the power of peer support, (3) an upbeat environment, and (4) experiences that interrupt being in Horyzons. Conclusions: We found that Horyzon’s therapeutic social network fostered a connection and an understanding among young people. It also aided in the creation of an embodied experience that afforded young people with FEP a sense of self-recognition and belonging over the long term. However, although we found that most young people had strong positive experiences of a social connection on Horyzons, we also found that they experienced significant barriers that could substantively interrupt their ability to use the platform. We found that social anxiety, paranoia, internalized stigma, lack of autonomy, and social protocol confusion interfered with young people’s usage of the platform. From a design perspective, digital interventions are flexible and thus equipped to begin addressing these implications by providing customizable and personalized treatment options that account for varying levels of social connection and psychological need that could otherwise interrupt young people’s usage of social media–based interventions. %M 32384056 %R 10.2196/17570 %U https://www.jmir.org/2020/6/e17570 %U https://doi.org/10.2196/17570 %U http://www.ncbi.nlm.nih.gov/pubmed/32384056 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 7 %N 6 %P e15942 %T Surveying the Role of Analytics in Evaluating Digital Mental Health Interventions for Transition-Aged Youth: Scoping Review %A Lo,Brian %A Shi,Jenny %A Hollenberg,Elisa %A Abi-Jaoudé,Alexxa %A Johnson,Andrew %A Wiljer,David %+ Education, Technology and Innovation, University Health Network, 3-RFE-441, 190 Elizabeth Street, Toronto, ON, M5G 2C4, Canada, 1 4163404800 ext 6322, David.Wiljer@uhn.ca %K user engagement %K mobile apps %K mHealth %K telemedicine %K mental health %K adolescent %K data analytics %D 2020 %7 25.6.2020 %9 Review %J JMIR Ment Health %G English %X Background: Consumer-facing digital health interventions provide a promising avenue to bridge gaps in mental health care delivery. To evaluate these interventions, understanding how the target population uses a solution is critical to the overall validity and reliability of the evaluation. As a result, usage data (analytics) can provide a proxy for evaluating the engagement of a solution. However, there is paucity of guidance on how usage data or analytics should be used to assess and evaluate digital mental health interventions. Objective: This review aimed to examine how usage data are collected and analyzed in evaluations of mental health mobile apps for transition-aged youth (15-29 years). Methods: A scoping review was conducted using the Arksey and O’Malley framework. A systematic search was conducted on 5 journal databases using keywords related to usage and engagement, mental health apps, and evaluation. A total of 1784 papers from 2008 to 2019 were identified and screened to ensure that they included analytics and evaluated a mental health app for transition-aged youth. After full-text screening, 49 papers were included in the analysis. Results: Of the 49 papers included in the analysis, 40 unique digital mental health innovations were evaluated, and about 80% (39/49) of the papers were published over the past 6 years. About 80% involved a randomized controlled trial and evaluated apps with information delivery features. There were heterogeneous findings in the concept that analytics was ascribed to, with the top 3 being engagement, adherence, and acceptability. There was also a significant spread in the number of metrics collected by each study, with 35% (17/49) of the papers collecting only 1 metric and 29% (14/49) collecting 4 or more analytic metrics. The number of modules completed, the session duration, and the number of log ins were the most common usage metrics collected. Conclusions: This review of current literature identified significant variability and heterogeneity in using analytics to evaluate digital mental health interventions for transition-aged youth. The large proportion of publications from the last 6 years suggests that user analytics is increasingly being integrated into the evaluation of these apps. Numerous gaps related to selecting appropriate and relevant metrics and defining successful or high levels of engagement have been identified for future exploration. Although long-term use or adoption is an important precursor to realizing the expected benefits of an app, few studies have examined this issue. Researchers would benefit from clarification and guidance on how to measure and analyze app usage in terms of evaluating digital mental health interventions for transition-aged youth. Given the established role of adoption in the success of health information technologies, understanding how to abstract and analyze user adoption for consumer digital mental health apps is also an emerging priority. %M 32348261 %R 10.2196/15942 %U https://mental.jmir.org/2020/6/e15942 %U https://doi.org/10.2196/15942 %U http://www.ncbi.nlm.nih.gov/pubmed/32348261 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 6 %P e16631 %T A Blended Physiotherapy Intervention for Persons With Hemophilic Arthropathy: Development Study %A Timmer,Merel A %A Kloek,Corelien J J %A de Kleijn,Piet %A Kuijlaars,Isolde A R %A Schutgens,Roger E G %A Veenhof,Cindy %A Pisters,Martijn F %+ van Creveldkliniek, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, 3508 GA, Netherlands, 31 88 755 1709, m.a.timmer@umcutrecht.nl %K hemophilia %K physiotherapy %K exercise %K eHealth %K blended care %K mobile phone %D 2020 %7 19.6.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Joint bleeds are the hallmark of hemophilia, leading to a painful arthritic condition called as hemophilic arthropathy (HA). Exercise programs are frequently used to improve the physical functioning in persons with HA. As hemophilia is a rare disease, there are not many physiotherapists who are experienced in the field of hemophilia, and regular physiotherapy sessions with an experienced physiotherapist in the field of hemophilia are not feasible for persons with HA. Blended care is an innovative intervention that can support persons with HA at home to perform the advised physical activities and exercises and provide self-management information. Objective: The aim of this study was to develop a blended physiotherapy intervention for persons with HA. Methods: The blended physiotherapy intervention, namely, e-Exercise HA was developed by cocreation with physiotherapists, persons with HA, software developers, and researchers. The content of e-Exercise HA was compiled using the first 3 steps of the Center for eHealth Research roadmap model (ie, contextual inquiry, value specification, and design), including people with experience in the development of previous blended physiotherapy interventions, a literature search, and focus groups. Results: A 12-week blended intervention was developed, integrating face-to-face physiotherapy sessions with a web-based app. The intervention consists of information modules for persons with HA and information modules for physiotherapists, a graded activity program using a self-chosen activity, and personalized video-supported exercises. The information modules consist of text blocks, videos, and reflective questions. The patients can receive pop-ups as reminders and give feedback on the performance of the prescribed activities. Conclusions: In this study, we developed a blended physiotherapy intervention for persons with HA, which consists of information modules, a graded activity program, and personalized video-supported exercises. %M 32558654 %R 10.2196/16631 %U http://www.jmir.org/2020/6/e16631/ %U https://doi.org/10.2196/16631 %U http://www.ncbi.nlm.nih.gov/pubmed/32558654 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 7 %N 6 %P e16730 %T Engaging With a Web-Based Psychosocial Intervention for Psychosis: Qualitative Study of User Experiences %A Arnold,Chelsea %A Williams,Anne %A Thomas,Neil %+ Centre for Mental Health, Swinburne University of Technology, John St, Hawthorn, Australia, 61 3 9214 4476, carnold@swin.edu.au %K psychosis %K engagement %K qualitative research %K eHealth %K internet intervention %K mobile phone %D 2020 %7 19.6.2020 %9 Original Paper %J JMIR Ment Health %G English %X Background: Web-based interventions are increasingly being used for individuals with serious mental illness, including psychosis, and preliminary evidence suggests clinical benefits. To achieve such benefits, individuals must have some level of engagement with the intervention. Currently, little is known about what influences engagement with web-based interventions for individuals with psychotic disorders. Objective: This study aimed to explore users' perspectives on what influenced engagement with a web-based intervention for psychosis. Methods: A qualitative design was employed using semistructured telephone interviews. Participants were 17 adults with psychosis who had participated in a trial examining engagement with a self-guided, web-based intervention promoting personal recovery and self-management of mental health. Results: We identified 2 overarching themes: challenges to using the website and factors supporting persistence. Both of the main themes included several subthemes related to both user-related factors (eg, mental health, personal circumstances, approach to using the website) and users’ experience of the intervention (eg, having experienced similar content previously or finding the material confronting). Conclusions: Individuals with psychosis experienced several challenges to ongoing engagement with a web-based intervention. Adjunctive emails present an important design feature to maintain interest and motivation to engage with the intervention. However, fluctuations in mental health and psychosocial difficulties are a significant challenge. Design and implementation considerations include flexible interventions with tailoring opportunities to accommodate changeable circumstances and individual preferences. %M 32558659 %R 10.2196/16730 %U https://mental.jmir.org/2020/6/e16730 %U https://doi.org/10.2196/16730 %U http://www.ncbi.nlm.nih.gov/pubmed/32558659 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 6 %P e17902 %T Evaluation of an On-Demand Mental Health System for Depression Symptoms: Retrospective Observational Study %A Kunkle,Sarah %A Yip,Manny %A Ξ,Watson %A Hunt,Justin %+ Ginger, 116 New Montgomery St Suite 500, San Francisco, CA, 94105, United States, 1 7175197355, sarah@ginger.io %K mental health %K depression %K digital health %K therapy %K coaching %K behavioral health %K virtual care %D 2020 %7 18.6.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression is an extremely prevalent issue in the United States, with an estimated 7% of adults experiencing at least one major depressive episode in 2017. Although psychotherapy and medication management are effective treatments for depression, significant barriers in accessing care persist. Virtual care can potentially address some of these obstacles. Objective: We conducted a preliminary investigation of utilization characteristics and effectiveness of an on-demand health system for reducing depression symptoms. Methods: Data were analyzed from 1662 users of an on-demand mental health system that includes behavioral health coaching, clinical services (therapy and psychiatry), and self-guided content and assessments primarily via a mobile app platform. Measures included engagement characterized by mobile app data, member satisfaction scores collected via in-app surveys, and depression symptoms via the Patient Health Questionnaire-2 (PHQ-2) at baseline and 8-12 week follow-up. Descriptive statistics are reported for measures, and pre/post-PHQ-2 data were analyzed using the McNemar test. A chi-square test was used to test the association between the proportion of individuals with an improvement in PHQ-2 result and care modality (coaching, therapy, and psychiatry, or hybrid). Results: During the study period, 65.5% of individuals (1089/1662) engaged only in coaching services, 27.6% of individuals (459/1662) were engaged in both coaching and clinical services, 3.3% of individuals (54/1662) engaged only in clinical services, and 3.7% of individuals (61/1662) only used the app. Of the 1662 individuals who completed the PHQ-2 survey, 772 (46.5%) were considered a positive screen at intake, and 890 (53.6%) were considered a negative screen at intake. At follow-up, 477 (28.7%) of individuals screened positive, and 1185 (71.3%) screened negative. A McNemar test showed that there was a statistically significant decrease in the proportion of users experiencing depressed mood and anhedonia more than half the time at follow-up (P<.001). A chi-square test showed there was no significant association between care modality and the proportion of individuals with an improvement in PHQ-2 score. Conclusions: This study provides preliminary insights into which aspects of an on-demand mental health system members are utilizing and levels of engagement and satisfaction over an 8-12 week window. Additionally, there is some signal that this system may be useful for reducing depression symptoms in users over this period. Additional research is required, given the study limitations, and future research directions are discussed. %M 32554387 %R 10.2196/17902 %U http://www.jmir.org/2020/6/e17902/ %U https://doi.org/10.2196/17902 %U http://www.ncbi.nlm.nih.gov/pubmed/32554387 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 6 %P e17586 %T Challenges and Benefits of an Internet-Based Intervention With a Peer Support Component for Older Adults With Depression: Qualitative Analysis of Textual Data %A Chen,Annie T %A Slattery,Krystal %A Tomasino,Kathryn N %A Rubanovich,Caryn Kseniya %A Bardsley,Leland R %A Mohr,David C %+ Department of Biomedical Informatics and Medical Education, University of Washington School of Medicine, 850 Republican Street, Box 358047, UW Medicine South Lake Union, Seattle, WA, 98109, United States, 1 2062219218, atchen@uw.edu %K aged %K depression %K internet %K peer group %K social support %K qualitative research %D 2020 %7 16.6.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Technological interventions provide many opportunities for improving the health and quality of life of older adults. However, interaction with new technologies can also cause frustration. Although these themes have been explored in extant research, much remains to be learned with regard to how the challenges of aging and technology use and the experiences of participating in a social and learning environment are interrelated. Objective: This study aimed to perform a qualitative analysis of data collected from MoodTech, a pilot study of an internet-based intervention with a peer support component for older adults with symptoms of depression, to better understand the participants’ experience of using technological interventions, including the challenges and benefits that they experienced over the course of these interventions. Methods: We employed an inductive qualitative analysis method based on grounded theory methodology and interpretative phenomenological analysis to analyze participant textual data. These textual data were of 3 main types: (1) assignments in which participants challenged their negative thoughts, (2) status updates, and (3) comments in the peer support component of the intervention. Results: We have presented the results through 3 main themes: (1) the challenges of aging as seen through the participants’ comments, (2) the difficulties experienced by the participants in using MoodTech, and (3) the benefits they derived from participating. Conclusions: This paper offers several contributions concerning study participants’ experiences with internet-based cognitive behavioral therapy (iCBT) interventions with a peer support component and design considerations for developing complex technological interventions that support the challenges participants experience due to aging and cognitive difficulties. First, technical issues encountered by older adults within the context of the intervention can interact with and exacerbate the insecurities they experience in life, and it is important to consider how intervention components might be designed to mitigate these issues. Second, peer support can be employed as a mechanism to facilitate communication, support, and collaborative problem solving among participants in an intervention. The insights from this paper can inform the design of iCBT interventions for older adults. %M 32543448 %R 10.2196/17586 %U https://www.jmir.org/2020/6/e17586 %U https://doi.org/10.2196/17586 %U http://www.ncbi.nlm.nih.gov/pubmed/32543448 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 6 %P e15449 %T User-Centered Design of a Mobile Health Intervention to Enhance Exacerbation-Related Self-Management in Patients With Chronic Obstructive Pulmonary Disease (Copilot): Mixed Methods Study %A Korpershoek,Yvonne J G %A Hermsen,Sander %A Schoonhoven,Lisette %A Schuurmans,Marieke J %A Trappenburg,Jaap C A %+ Research Group Chronic Illnesses, University of Applied Sciences Utrecht, Heidelberglaan 7, Utrecht, 3584 CS, Netherlands, 31 6 38763949, yvonne.korpershoek@hu.nl %K mobile health %K mHealth %K user-centered design %K behavior change %K COPD %K exacerbation %K self-management %K self-care %K mobile phone %D 2020 %7 15.6.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Adequate self-management skills are of great importance for patients with chronic obstructive pulmonary disease (COPD) to reduce the impact of COPD exacerbations. Using mobile health (mHealth) to support exacerbation-related self-management could be promising in engaging patients in their own health and changing health behaviors. However, there is limited knowledge on how to design mHealth interventions that are effective, meet the needs of end users, and are perceived as useful. By following an iterative user-centered design (UCD) process, an evidence-driven and usable mHealth intervention was developed to enhance exacerbation-related self-management in patients with COPD. Objective: This study aimed to describe in detail the full UCD and development process of an evidence-driven and usable mHealth intervention to enhance exacerbation-related self-management in patients with COPD. Methods: The UCD process consisted of four iterative phases: (1) background analysis and design conceptualization, (2) alpha usability testing, (3) iterative software development, and (4) field usability testing. Patients with COPD, health care providers, COPD experts, designers, software developers, and a behavioral scientist were involved throughout the design and development process. The intervention was developed using the behavior change wheel (BCW), a theoretically based approach for designing behavior change interventions, and logic modeling was used to map out the potential working mechanism of the intervention. Furthermore, the principles of design thinking were used for the creative design of the intervention. Qualitative and quantitative research methods were used throughout the design and development process. Results: The background analysis and design conceptualization phase resulted in final guiding principles for the intervention, a logic model to underpin the working mechanism of the intervention, and design requirements. Usability requirements were obtained from the usability testing phases. The iterative software development resulted in an evidence-driven and usable mHealth intervention—Copilot, a mobile app consisting of a symptom-monitoring module, and a personalized COPD action plan. Conclusions: By following a UCD process, an mHealth intervention was developed that meets the needs and preferences of patients with COPD, is likely to be used by patients with COPD, and has a high potential to be effective in reducing exacerbation impact. This extensive report of the intervention development process contributes to more transparency in the development of complex interventions in health care and can be used by researchers and designers as guidance for the development of future mHealth interventions. %M 32538793 %R 10.2196/15449 %U https://www.jmir.org/2020/6/e15449 %U https://doi.org/10.2196/15449 %U http://www.ncbi.nlm.nih.gov/pubmed/32538793 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 6 %P e15001 %T Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial %A MacLean,Sarah %A Corsi,Daniel J %A Litchfield,Sadie %A Kucharski,Julia %A Genise,Kira %A Selaman,Zeynep %A Testa,Valerie %A Hatcher,Simon %+ Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1919 Riverside Drive, Suite 406, Ottawa, ON, K1H 7W9, Canada, 1 613 737 8899, shatcher@toh.ca %K major depressive disorder %K secondary care %K randomized controlled trial %K telemedicine %K digital health technologies %K Canada %D 2020 %7 9.6.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression. Objective: We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (The Journal) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks. Methods: We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9). Results: A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was −3.6 (SD 6.6) in the intervention group and −3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t91=−0.37; P=.72, 95% CI −3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t84=−2.73; P=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in The Journal and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in The Journal, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ21=6.3; P=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention. Conclusions: The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective. Trial Registration: ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733 %M 32515740 %R 10.2196/15001 %U https://www.jmir.org/2020/6/e15001 %U https://doi.org/10.2196/15001 %U http://www.ncbi.nlm.nih.gov/pubmed/32515740 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 6 %P e18315 %T Evaluation of Digital Technologies Tailored to Support Young People’s Self-Management of Musculoskeletal Pain: Mixed Methods Study %A Slater,Helen %A Stinson,Jennifer N %A Jordan,Joanne E %A Chua,Jason %A Low,Ben %A Lalloo,Chitra %A Pham,Quynh %A Cafazzo,Joseph A %A Briggs,Andrew M %+ School of Physiotherapy and Exercise Science, Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, 6845, Australia, 61 892663099, H.Slater@curtin.edu.au %K musculoskeletal pain %K mHealth %K eHealth %K self-management %K adolescent %K mobile phone %K smartphone %D 2020 %7 5.6.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital technologies connect young people with health services and resources that support their self-care. The lack of accessible, reliable digital resources tailored to young people with persistent musculoskeletal pain is a significant gap in the health services in Australia. Recognizing the intense resourcing required to develop and implement effective electronic health (eHealth) interventions, the adaptation of extant, proven digital technologies may improve access to pain care with cost and time efficiencies. Objective: This study aimed to test the acceptability and need for adaptation of extant digital technologies, the painHEALTH website and the iCanCope with Pain app, for use by young Australians with musculoskeletal pain. Methods: A 3-phased, mixed methods evaluation was undertaken from May 2019 to August 2019 in Australia. Young people aged 15 to 25 years with musculoskeletal pain for >3 months were recruited. Phases were sequential: (1) phase 1, participant testing (3 groups, each of n=5) of co-designed website prototypes compared with a control website (painHEALTH), with user tasks mapped to eHealth quality and engagement criteria; (2) phase 2, participants’ week-long use of the iCanCope with Pain app with engagement data captured using a real-time analytic platform (daily check-ins for pain, interference, sleep, mood, physical activity, and energy levels; goal setting; and accessing resources); and (3) phase 3, semistructured interviews were conducted to gain insights into participants’ experiences of using these digital technologies. Results: Fifteen young people (12/15, 80% female; mean age 20.5 [SD 3.3] years; range 15-25 years) participated in all 3 phases. The phase 1 aggregated group data informed the recommendations used to guide 3 rapid cycles of prototype iteration. Adaptations included optimizing navigation, improving usability (functionality), and enhancing content to promote user engagement and acceptability. In phase 2, all participants checked in, with the highest frequency of full check-ins attributed to pain intensity (183/183, 100.0%), pain interference (175/183, 95.6%), and mood (152/183, 83.1%), respectively. Individual variability was evident for monitoring progress with the highest frequency of history views for pain intensity (51/183, 32.3%), followed by pain interference (24/183, 15.2%). For the goals set feature, 87% (13/15) of participants set a total of 42 goals covering 5 areas, most frequently for activity (35/42, 83%). For phase 3, metasynthesis of qualitative data highlighted that these digital tools were perceived as youth-focused and acceptable. A total of 4 metathemes emerged: (1) importance of user-centered design to leverage user engagement; (2) website design (features) promoting user acceptability and engagement; (3) app functionality supporting self-management; and (4) the role of wider promotion, health professional digital prescriptions, and strategies to ensure longer-term engagement. Conclusions: Leveraging extant digital tools, with appropriate user-informed adaptations, can help to build capacity tailored to support young people’s self-management of musculoskeletal pain. %M 32442143 %R 10.2196/18315 %U https://www.jmir.org/2020/6/e18315 %U https://doi.org/10.2196/18315 %U http://www.ncbi.nlm.nih.gov/pubmed/32442143 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 6 %P e17849 %T Health Equity in the Effectiveness of Web-Based Health Interventions for the Self-Care of People With Chronic Health Conditions: Systematic Review %A Turnbull,Sophie %A Cabral,Christie %A Hay,Alastair %A Lucas,Patricia J %+ Centre for Academic Primary Care, Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, , United Kingdom, 44 117 331 0590, sophie.turnbull@bristol.ac.uk %K health equity %K self-care %K eHealth %K intervention %K diabetes %K asthma %K pulmonary disease, chronic obstructive %K osteoarthritis %D 2020 %7 5.6.2020 %9 Review %J J Med Internet Res %G English %X Background: Web-based self-care interventions have the potential to reduce health inequalities by removing barriers to access to health care. However, there is a lack of evidence about the equalizing effects of these interventions on chronic conditions. Objective: This study investigated the differences in the effectiveness of web-based behavioral change interventions for the self-care of high burden chronic health conditions (eg, asthma, chronic obstructive pulmonary disease [COPD], diabetes, and osteoarthritis) across socioeconomic and cultural groups. Methods: A systematic review was conducted, following Cochrane review guidelines. We conducted searches in Ovid Medical Literature Analysis and Retrieval System Online and Cumulative Index to Nursing and Allied Health Literature databases. Studies with any quantitative design were included (published between January 1, 2006, and February 20, 2019) if they investigated web-based self-care interventions targeting asthma, COPD, diabetes, and osteoarthritis; were conducted in any high-income country; and reported variations in health, behavior, or psychosocial outcomes across social groups. Study outcomes were investigated for heterogeneity, and the possibility of a meta-analysis was explored. A narrative synthesis was provided together with a novel figure that was developed for this review, displaying heterogeneous outcomes. Results: Overall, 7346 records were screened and 18 studies were included, most of which had a high or critical risk of bias. Important study features and essential data were often not reported. The meta-analysis was not possible due to the heterogeneity of outcomes. There was evidence that intervention effectiveness was modified by participants’ social characteristics. Minority ethnic groups were found to benefit more from interventions than majority ethnic groups. Single studies with variable quality showed that those with higher education, who were employed, and adolescents with divorced parents benefited more from interventions. The evidence for differences by age, gender, and health literacy was conflicting (eg, in some instances, older people benefited more, and in others, younger people benefited more). There was no evidence of differences in income, numeracy, or household size. Conclusions: There was evidence that web-based self-care interventions for chronic conditions can be advantageous for some social groups (ie, minority ethnic groups, adolescents with divorced parents) and disadvantageous for other (ie, low education, unemployed) social groups who have historically experienced health inequity. However, these findings should be treated with caution as most of the evidence came from a small number of low-quality studies. The findings for gender and health literacy were mixed across studies on diabetes, and the findings for age were mixed across studies on asthma, COPD, and diabetes. There was no evidence that income, numeracy, or the number of people living in the household modified intervention effectiveness. We conclude that there appear to be interaction effects, which warrant exploration in future research, and recommend a priori consideration of the predicted interaction effects. Trial Registration: PROSPERO CRD42017056163; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=56163 %M 32459632 %R 10.2196/17849 %U http://www.jmir.org/2020/6/e17849/ %U https://doi.org/10.2196/17849 %U http://www.ncbi.nlm.nih.gov/pubmed/32459632 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 6 %P e15845 %T Efficacy of Three Low-Intensity, Internet-Based Psychological Interventions for the Treatment of Depression in Primary Care: Randomized Controlled Trial %A Gili,Margalida %A Castro,Adoración %A García-Palacios,Azucena %A Garcia-Campayo,Javier %A Mayoral-Cleries,Fermin %A Botella,Cristina %A Roca,Miquel %A Barceló-Soler,Alberto %A Hurtado,María M %A Navarro,MªTeresa %A Villena,Amelia %A Pérez-Ara,M Ángeles %A Riera-Serra,Pau %A Baños,Rosa Mª %+ Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Carretera de Valldemossa, Palma de Mallorca, 07122, Spain, 34 173081, mgili@uib.es %K depression %K primary care %K internet-based interventions %K randomized controlled trial %D 2020 %7 5.6.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Primary care is a major access point for the initial treatment of depression, but the management of these patients is far from optimal. The lack of time in primary care is one of the major difficulties for the delivery of evidence-based psychotherapy. During the last decade, research has focused on the development of brief psychotherapy and cost-effective internet-based interventions mostly based on cognitive behavioral therapy (CBT). Very little research has focused on alternative methods of treatment for depression using CBT. Thus, there is a need for research into other therapeutic approaches. Objective: This study aimed to assess the effectiveness of 3 low-intensity, internet-based psychological interventions (healthy lifestyle psychoeducational program [HLP], focused program on positive affect promotion [PAPP], and brief intervention based on mindfulness [MP]) compared with a control condition (improved treatment as usual [iTAU]). Methods: A multicenter, 4-arm, parallel randomized controlled trial was conducted between March 2015 and March 2016, with a follow-up of 12 months. In total, 221 adults with mild or moderate major depression were recruited in primary care settings from 3 Spanish regions. Patients were randomly distributed to iTAU (n=57), HLP (n=54), PAPP (n=56), and MP (n=54). All patients received iTAU from their general practitioners. The main outcome was the Spanish version of the Patient Health Questionnaire-9 (PHQ-9) from pretreatment (time 1) to posttreatment (time 2) and up to 6 (time 3) and 12 (time 4) months’ follow-up. Secondary outcomes included the visual analog scale of the EuroQol, the Short-Form Health Survey (SF-12), the Positive and Negative Affect Schedule (PANAS), and the Pemberton Happiness Index (PHI). We conducted regression models to estimate outcome differences along study stages. Results: A moderate decrease was detected in PHQ-9 scores from HLP (β=–3.05; P=.01) and MP (β=–3.00; P=.01) compared with iTAU at posttreatment. There were significant differences between all intervention groups and iTAU in physical SF-12 scores at 6 months after treatment. Regarding well-being, MP and PAPP reported better PHI results than iTAU at 6 months post treatment. PAPP intervention significantly decreased PANAS negative affect scores compared with iTAU 12 months after treatment. Conclusions: The low-intensity, internet-based psychological interventions (HLP and MP) for the treatment of depression in primary care are more effective than iTAU at posttreatment. Moreover, all low-intensity psychological interventions are also effective in improving medium- and long-term quality of life. PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression. Nevertheless, it is important to examine possible reasons that could be implicated for PAPP not being effective in reducing depressive symptomatology; in addition, more research is still needed to assess the cost-effectiveness analysis of these interventions. Trial Registration: ISRCTN Registry ISRCTN82388279; http://www.isrctn.com/ISRCTN82388279 International Registered Report Identifier (IRRID): RR2-10.1186/s12888-015-0475-0 %M 32501276 %R 10.2196/15845 %U https://www.jmir.org/2020/6/e15845 %U https://doi.org/10.2196/15845 %U http://www.ncbi.nlm.nih.gov/pubmed/32501276 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 6 %P e15617 %T The Effectiveness of Digital Health Interventions in the Management of Musculoskeletal Conditions: Systematic Literature Review %A Hewitt,Stephanie %A Sephton,Ruth %A Yeowell,Gillian %+ Department of Health Professions, Manchester Metropolitan University, 34 Bonsall Street, Manchester, M15 6GX, United Kingdom, 44 1612472961, g.yeowell@mmu.ac.uk %K musculoskeletal pain %K physical functional performance %K health communication %K online intervention %K web-based intervention %K mobile phone %D 2020 %7 5.6.2020 %9 Review %J J Med Internet Res %G English %X Background: Musculoskeletal conditions are the second greatest contributor to disability worldwide and have significant individual, societal, and economic implications. Due to the growing burden of musculoskeletal disability, an integrated and strategic response is urgently required. Digital health interventions provide high-reach, low-cost, readily accessible, and scalable interventions for large patient populations that address time and resource constraints. Objective: This review aimed to investigate if digital health interventions are effective in reducing pain and functional disability in patients with musculoskeletal conditions. Methods: A systematic review was undertaken to address the research objective. The review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The review protocol was registered with the International Prospective Register of Systematic Reviews before commencement of the study. The following databases were searched: Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica database (EMBASE), Cumulative Index to Nursing and Allied Health Literature, and Scopus from January 1, 2000, to November 15, 2019, using search terms and database specific−medical subject headings terms in various combinations appropriate to the research objective. Results: A total of 19 English language studies were eligible for inclusion. Of the 19 studies that assessed musculoskeletal pain, 9 reported statistically significant reductions following digital intervention. In all, 16 studies investigated functional disability; 10 studies showed a statistically significant improvement. Significant improvements were also found in a range of additional outcomes. Due to the heterogeneity of the results, a meta-analysis was not feasible. Conclusions: This review has demonstrated that digital health interventions have some clinical benefits in the management of musculoskeletal conditions for pain and functional disability. Digital health interventions have the potential to contribute positively toward reducing the multifaceted burden of musculoskeletal conditions to the individual, economy, and society. Trial Registration: PROSPERO CRD42018093343; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=93343 %M 32501277 %R 10.2196/15617 %U https://www.jmir.org/2020/6/e15617 %U https://doi.org/10.2196/15617 %U http://www.ncbi.nlm.nih.gov/pubmed/32501277 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 6 %P e18343 %T A Social Media–Based Support Group for Youth Living With HIV in Nigeria (SMART Connections): Randomized Controlled Trial %A Dulli,Lisa %A Ridgeway,Kathleen %A Packer,Catherine %A Murray,Kate R %A Mumuni,Tolulope %A Plourde,Kate F %A Chen,Mario %A Olumide,Adesola %A Ojengbede,Oladosu %A McCarraher,Donna R %+ FHI 360, 359 Blackwell St, Suite 200, Durham, NC, 27701, United States, 1 9195447040 ext 11396, ldulli@fhi360.org %K HIV %K treatment adherence and compliance %K youth %K social support %K mHealth %K medication adherence %K mobile phone %D 2020 %7 2.6.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Youth living with HIV (YLHIV) enrolled in HIV treatment experience higher loss to follow-up, suboptimal treatment adherence, and greater HIV-related mortality compared with younger children or adults. Despite poorer health outcomes, few interventions target youth specifically. Expanding access to mobile phone technology, in low- and middle-income countries (LMICs) in particular, has increased interest in using this technology to improve health outcomes. mHealth interventions may present innovative opportunities to improve adherence and retention among YLHIV in LMICs. Objective: This study aimed to test the effectiveness of a structured support group intervention, Social Media to promote Adherence and Retention in Treatment (SMART) Connections, delivered through a social media platform, on HIV treatment retention among YLHIV aged 15 to 24 years and on secondary outcomes of antiretroviral therapy (ART) adherence, HIV knowledge, and social support. Methods: We conducted a parallel, unblinded randomized controlled trial. YLHIV enrolled in HIV treatment for less than 12 months were randomized in a 1:1 ratio to receive SMART Connections (intervention) or standard of care alone (control). We collected data at baseline and endline through structured interviews and medical record extraction. We also conducted in-depth interviews with subsets of intervention group participants. The primary outcome was retention in HIV treatment. We conducted a time-to-event analysis examining time retained in treatment from study enrollment to the date the participant was no longer classified as active-on-treatment. Results: A total of 349 YLHIV enrolled in the study and were randomly allocated to the intervention group (n=177) or control group (n=172). Our primary analysis included data from 324 participants at endline. The probability of being retained in treatment did not differ significantly between the 2 study arms during the study. Retention was high at endline, with 75.7% (112/163) of intervention group participants and 83.4% (126/161) of control group participants active on treatment. HIV-related knowledge was significantly better in the intervention group at endline, but no statistically significant differences were found for ART adherence or social support. Intervention group participants overwhelmingly reported that the intervention was useful, that they enjoyed taking part, and that they would recommend it to other YLHIV. Conclusions: Our findings of improved HIV knowledge and high acceptability are encouraging, despite a lack of measurable effect on retention. Retention was greater than anticipated in both groups, likely a result of external efforts that began partway through the study. Qualitative data indicate that the SMART Connections intervention may have contributed to retention, adherence, and social support in ways that were not captured quantitatively. Web-based delivery of support group interventions can permit people to access information and other group members privately, when convenient, and without travel. Such digital health interventions may help fill critical gaps in services available for YLHIV. Trial Registration: ClinicalTrials.gov NCT03516318; https://clinicaltrials.gov/ct2/show/NCT03516318 %M 32484444 %R 10.2196/18343 %U https://www.jmir.org/2020/6/e18343 %U https://doi.org/10.2196/18343 %U http://www.ncbi.nlm.nih.gov/pubmed/32484444 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 6 %P e15964 %T A Digital Pornography Literacy Resource Co-Designed With Vulnerable Young People: Development of "The Gist" %A Davis,Angela C %A Wright,Cassandra JC %A Murphy,Stacey %A Dietze,Paul %A Temple-Smith,Meredith J %A Hellard,Margaret E %A Lim,Megan SC %+ Burnet Institute, GPO Box 2284, Melbourne, 3181, Australia, 61 3 9282 2111, angela.davis@burnet.edu.au %K co-design %K pornography literacy %K sexual health %K sex education %D 2020 %7 1.6.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: The impact of viewing pornography at a young age on the sexual health of subgroups of young people is an important public health issue. However, the topic is complex and extremely sensitive, and best practices for research and harm reduction are yet to be defined. Drawing on cross-disciplinary approaches, such as co-design, is one way to achieve a better understanding of the issue among vulnerable young people and to create needs-based and evidence-informed digital resources to promote pornography literacy. Objective: The objective of this study was to co-design a relevant, usable, and acceptable digital prototype to address the pornography literacy needs of vulnerable young people. Methods: In total, 17 young people aged between 14 and 23 years who were engaged in youth services programs or alternative education programs were recruited to participate in 4 co-design workshops with a multidisciplinary design team. Results: Although the participants could identify problems with pornography and critique its messages, they lacked the information to understand alternative healthy attitudes and behaviors. A digital resource that provides detailed and practical information about sex, sexual ethics, and relationships may help vulnerable young people to identify and contrast with any problematic messages they receive from both pornography and society. Embedding this information with pornography literacy messages may be a more effective way of addressing underlying attitudes. Acknowledging information-seeking patterns and leveraging user interaction patterns from commonly used digital platforms among users may enhance engagement with resources. Importantly, digital platforms are perceived among this group as a source of anonymous secondary information but would not be organically accessed among this group without face-to-face conversations as an access point. Conclusions: This paper highlights the potential for pornography literacy to be embedded within real and practical information about having sex, navigating sexuality, and healthy relationships. The study findings include important recommendations for the conceptualization of digital pornography literacy programs and opportunities for cross-disciplinary co-design research to address complex and emerging health issues. %M 32348268 %R 10.2196/15964 %U https://www.jmir.org/2020/6/e15964 %U https://doi.org/10.2196/15964 %U http://www.ncbi.nlm.nih.gov/pubmed/32348268 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 6 %N 2 %P e19033 %T A Web- and App-Based Connected Care Solution for COVID-19 In- and Outpatient Care: Qualitative Study and Application Development %A Schinköthe,Timo %A Gabri,Mariano Rolando %A Mitterer,Manfred %A Gouveia,Pedro %A Heinemann,Volker %A Harbeck,Nadia %A Subklewe,Marion %+ CANKADO, Eupener Sraße 165, Cologne, 50933, Germany, 49 221 429 153 00, t.schinkoethe@cankado.com %K COVID-19 %K eHealth %K connected care %K telecare %K cloud solution %K telehealth %K public health %K infectious disease %K pandemic %K outbreak %D 2020 %7 1.6.2020 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: From the perspective of health care professionals, coronavirus disease (COVID-19) brings many challenges as well as opportunities for digital health care. One challenge is that health care professionals are at high risk of infection themselves. Therefore, in-person visits need to be reduced to an absolute minimum. Connected care solutions, including telehealth, remote patient monitoring, and secure communications between clinicians and their patients, may rapidly become the first choice in such public health emergencies. Objective: The aim of the COVID-19 Caregiver Cockpit (C19CC) was to implement a free-of-charge, web- and app-based tool for patient assessment to assist health care professionals working in the COVID-19 environment. Methods: Physicians in Argentina, Germany, Iran, Italy, Portugal, Switzerland, and the United States explained their challenges with COVID-19 patient care through unstructured interviews. Based on the collected feedback, the first version of the C19CC was built. In the second round of interviews, the application was presented to physicians, and more feedback was obtained. Results: Physicians identified a number of different scenarios where telemedicine or connected care solutions could rapidly improve patient care. These scenarios included outpatient care, discharge management, remote tracking of patients with chronic diseases, as well as incorporating infected physicians under quarantine into telehealth services. Conclusions: The C19CC is the result of an agile and iterative development process that complements the work of physicians. It aims to improve the care and safety of people who are infected by COVID-19. %M 32406855 %R 10.2196/19033 %U http://publichealth.jmir.org/2020/2/e19033/ %U https://doi.org/10.2196/19033 %U http://www.ncbi.nlm.nih.gov/pubmed/32406855 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 5 %P e17792 %T The Impact of a Tablet App on Adherence to American Heart Association Guidelines During Simulated Pediatric Cardiopulmonary Resuscitation: Randomized Controlled Trial %A Siebert,Johan N %A Lacroix,Laurence %A Cantais,Aymeric %A Manzano,Sergio %A Ehrler,Frederic %+ Department of Pediatric Emergency Medicine, Geneva Children’s Hospital, Geneva University Hospitals, Avenue de la Roseraie, 47, 1211 Geneva 14, Switzerland, 41 795534072, Johan.Siebert@hcuge.ch %K biomedical technologies %K mobile apps %K emergency medicine %K pediatrics %K resuscitation %K guideline adherence %D 2020 %7 27.5.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Evidence-based best practices are the cornerstone to guide optimal cardiopulmonary arrest resuscitation care. Adherence to the American Heart Association (AHA) guidelines for cardiopulmonary resuscitation (CPR) optimizes the management of critically ill patients and increases their chances of survival after cardiac arrest. Despite advances in resuscitation science and survival improvement over the last decades, only approximately 38% of children survive to hospital discharge after in-hospital cardiac arrest and only 6%-20% after out-of-hospital cardiac arrest. Objective: We investigated whether a mobile app developed as a guide to support and drive CPR providers in real time through interactive pediatric advanced life support (PALS) algorithms would increase adherence to AHA guidelines and reduce the time to initiation of critical life-saving maneuvers compared to the use of PALS pocket reference cards. Methods: This study was a randomized controlled trial conducted during a simulation-based pediatric cardiac arrest scenario caused by pulseless ventricular tachycardia (pVT). A total of 26 pediatric residents were randomized into two groups. The primary outcome was the elapsed time in seconds in each allocation group from the onset of pVT to the first defibrillation attempt. Secondary outcomes were time elapsed to (1) initiation of chest compression, (2) subsequent defibrillation attempts, and (3) administration of drugs, including the time intervals between defibrillation attempts and drug doses, shock doses, and the number of shocks. All outcomes were assessed for deviation from AHA guidelines. Results: Mean time to the first defibrillation attempt (121.4 sec, 95% CI 105.3-137.5) was significantly reduced among residents using the app compared to those using PALS pocket cards (211.5 sec, 95% CI 162.5-260.6, P<.001). With the app, 11 out of 13 (85%) residents initiated chest compressions within 60 seconds from the onset of pVT and 12 out of 13 (92%) successfully defibrillated within 180 seconds. Time to all other defibrillation attempts was reduced with the app. Adherence to the 2018 AHA pVT algorithm improved by approximately 70% (P=.001) when using the app following all CPR sequences of action in a stepwise fashion until return of spontaneous circulation. The pVT rhythm was recognized correctly in 51 out of 52 (98%) opportunities among residents using the app compared to only 19 out of 52 (37%) among those using PALS cards (P<.001). Time to epinephrine injection was similar. Among a total of 78 opportunities, incorrect shock or drug doses occurred in 14% (11/78) of cases among those using the cards. These errors were reduced to 1% (1/78, P=.005) when using the app. Conclusions: Use of the mobile app was associated with a shorter time to first and subsequent defibrillation attempts, fewer medication and defibrillation dose errors, and improved adherence to AHA recommendations compared with the use of PALS pocket cards. %M 32292179 %R 10.2196/17792 %U http://www.jmir.org/2020/5/e17792/ %U https://doi.org/10.2196/17792 %U http://www.ncbi.nlm.nih.gov/pubmed/32292179 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 5 %P e16906 %T Integrating People, Context, and Technology in the Implementation of a Web-Based Intervention in Forensic Mental Health Care: Mixed-Methods Study %A Kip,Hanneke %A Sieverink,Floor %A van Gemert-Pijnen,Lisette J E W C %A Bouman,Yvonne H A %A Kelders,Saskia M %+ Centre for eHealth and Wellbeing Research, Department of Psychology, Health and Technology, University of Twente, Drienerlolaan 5, Enschede, Netherlands, 31 053 489 9111, h.kip@utwente.nl %K eHealth %K blended care %K implementation %K log data %K forensic mental health care %D 2020 %7 26.5.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: While eMental health interventions can have many potential benefits for mental health care, implementation outcomes are often disappointing. In order to improve these outcomes, there is a need for a better understanding of complex, dynamic interactions between a broad range of implementation-related factors. These interactions and processes should be studied holistically, paying attention to factors related to context, technology, and people. Objective: The main objective of this mixed-method study was to holistically evaluate the implementation strategies and outcomes of an eMental health intervention in an organization for forensic mental health care. Methods: First, desk research was performed on 18 documents on the implementation process. Second, the intervention’s use by 721 patients and 172 therapists was analyzed via log data. Third, semistructured interviews were conducted with all 18 therapists of one outpatient clinic to identify broad factors that influence implementation outcomes. The interviews were analyzed via a combination of deductive analysis using the nonadoption, abandonment, scale-up, spread, and sustainability framework and inductive, open coding. Results: The timeline generated via desk research showed that implementation strategies focused on technical skills training of therapists. Log data analyses demonstrated that 1019 modules were started, and 18.65% (721/3865) of patients of the forensic hospital started at least one module. Of these patients, 18.0% (130/721) completed at least one module. Of the therapists using the module, 54.1% (93/172 sent at least one feedback message to a patient. The median number of feedback messages sent per therapist was 1, with a minimum of 0 and a maximum of 460. Interviews showed that therapists did not always introduce the intervention to patients and using the intervention was not part of their daily routine. Also, therapists indicated patients often did not have the required conscientiousness and literacy levels. Furthermore, they had mixed opinions about the design of the intervention. Important organization-related factors were the need for more support and better integration in organizational structures. Finally, therapists stated that despite its current low use, the intervention had the potential to improve the quality of treatment. Conclusions: Synthesis of different types of data showed that implementation outcomes were mostly disappointing. Implementation strategies focused on technical training of therapists, while little attention was paid to changes in the organization, design of the technology, and patient awareness. A more holistic approach toward implementation strategies—with more attention to the organization, patients, technology, and training therapists—might have resulted in better implementation outcomes. Overall, adaptivity appears to be an important concept in eHealth implementation: a technology should be easily adaptable to an individual patient, therapists should be trained to deal flexibly with an eMental health intervention in their treatment, and organizations should adapt their implementation strategies and structures to embed a new eHealth intervention. %M 32348285 %R 10.2196/16906 %U http://www.jmir.org/2020/5/e16906/ %U https://doi.org/10.2196/16906 %U http://www.ncbi.nlm.nih.gov/pubmed/32348285 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 5 %P e14093 %T Occupational Health Needs and Predicted Well-Being in Office Workers Undergoing Web-Based Health Promotion Training: Cross-Sectional Study %A Tchir,Devan Richard %A Szafron,Michael Lorne %+ School of Public Health, University of Saskatchewan, 104 Clinic Place, Saskatoon, SK, S7N 2Z4, Canada, 1 3069665468, michael.szafron@usask.ca %K eHealth %K health promotion %K occupational health %K well-being %K internet %K workplace %D 2020 %7 26.5.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Office workers face workplace-related health issues, including stress and back pain, resulting in considerable cost to businesses and health care systems. Workplace health promotion attempts to prevent these health issues, and the internet can be used to deliver workplace health promotion interventions to office workers. Data were provided by Fitbase GmbH, a German company, which specializes in workplace health promotion via the internet (Web-based health). The Web-based health intervention allowed workers to focus on different health categories by using information modules (reading health information) and/or completing practical exercises (guided, interactive health tutorials). Objective: This study aimed to identify the extent to which office workers have workplace-related health issues, assess whether office workers who differ in their health focus also differ in their improved well-being, and assess whether completing practical exercises is associated with improved well-being compared with reading information modules. Methods: Fitbase GmbH collected data for the period of February 2016 to May 2017 from health insurance employees undergoing Web-based health training in Hamburg, Germany. The data consisted of a needs assessment examining health issues faced by office workers, a wellness questionnaire regarding one’s perception of the Web-based health intervention, and activity logs of information modules and practical exercises completed. Through logistic regression, we determined associations between improved well-being from Web-based health training and differences in a worker’s health focus and a worker’s preferred intervention method. Results: Nearly half of the office workers had chronic back pain (1532/3354) and felt tense or irritated (1680/3348). Over four-fifth (645/766) of the office workers indicated that the Web-based health training improved their well-being (P<.001). Office workers who preferred practical exercises compared with information modules had 2.22 times greater odds of reporting improved well-being from the Web-based health intervention (P=.01; 95% CI 1.20-4.11). Office workers with a focus on practical exercises for back health had higher odds of improved well-being compared with other health foci. Office workers focused on practical exercises for back pain had at least two times the odds of having their well-being improved from the Web-based health intervention compared with those focused on stress management (P<.001), mindfulness (P=.02), stress management/mindfulness (P=.005), and eye health (P=.003). No particular health focus was associated with improved well-being for the information modules. Conclusions: Office workers frequently report having back pain and stress. A focus on Web-based health training via practical exercises and practical exercises for back health predict an improvement in office workers’ reported well-being. %M 32452806 %R 10.2196/14093 %U http://www.jmir.org/2020/5/e14093/ %U https://doi.org/10.2196/14093 %U http://www.ncbi.nlm.nih.gov/pubmed/32452806 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 5 %P e14570 %T A Personalized eHealth Intervention for Lifestyle Changes in Patients With Cardiovascular Disease: Randomized Controlled Trial %A Broers,Eva Rosalinde %A Kop,Willem Johan %A Denollet,Johan %A Widdershoven,Jos %A Wetzels,Mart %A Ayoola,Idowu %A Piera-Jimenez,Jordi %A Habibovic,Mirela %+ Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands, 31 13 466 4020, m.habibovic@tilburguniversity.edu %K cardiovascular diseases %K lifestyle %K habits %K eHealth %K mHealth %D 2020 %7 22.5.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Behavior change methods involving new ambulatory technologies may improve lifestyle and cardiovascular disease outcomes. Objective: This study aimed to provide proof-of-concept analyses of an intervention aiming to increase (1) behavioral flexibility, (2) lifestyle change, and (3) quality of life. The feasibility and patient acceptance of the intervention were also evaluated. Methods: Patients with cardiovascular disease (N=149; mean age 63.57, SD 8.30 years; 50/149, 33.5% women) were recruited in the Do Cardiac Health Advanced New Generation Ecosystem (Do CHANGE) trial and randomized to the Do CHANGE intervention or care as usual (CAU). The intervention involved a 3-month behavioral program in combination with ecological momentary assessment and intervention technologies. Results: The intervention was perceived to be feasible and useful. A significant increase in lifestyle scores over time was found for both groups (F2,146.6=9.99; P<.001), which was similar for CAU and the intervention group (F1,149.9=0.09; P=.77). Quality of life improved more in the intervention group (mean 1.11, SD 0.11) than CAU (mean −1.47, SD 0.11) immediately following the intervention (3 months), but this benefit was not sustained at the 6-month follow-up (interaction: P=.02). No significant treatment effects were observed for behavioral flexibility (F1,149.0=0.48; P=.07). Conclusions: The Do CHANGE 1 intervention was perceived as useful and easy to use. However, no long-term treatment effects were found on the outcome measures. More research is warranted to examine which components of behavioral interventions are effective in producing long-term behavior change. Trial Registration: ClinicalTrials.gov NCT02946281; https://www.clinicaltrials.gov/ct2/show/NCT02946281 %M 32441658 %R 10.2196/14570 %U https://www.jmir.org/2020/5/e14570 %U https://doi.org/10.2196/14570 %U http://www.ncbi.nlm.nih.gov/pubmed/32441658 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 5 %P e16019 %T Efficacy of Text Messaging and Personal Consultation by Pharmacy Students Among Adults With Hypertension: Randomized Controlled Trial %A Zhai,Panpan %A Hayat,Khezar %A Ji,Wenjing %A Li,Qian %A Shi,Li %A Atif,Naveel %A Xu,Sen %A Li,Pengchao %A Du,Qianqian %A Fang,Yu %+ Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, No 76 Yanta West Road, Xi’an, 710061, China, 86 2982655132, yufang@mail.xjtu.edu.cn %K medication adherence %K text messaging %K hypertension %K consultation %K pharmacy students %D 2020 %7 20.5.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Hypertension is one of the leading risk factors for ischemic heart diseases, and high rates of hypertension prevalence have either remained the same or increased in developing countries in recent years. Unfortunately, about 20% to 50% of patients with chronic diseases have been nonadherent to their drug therapy. SMS text messaging and pharmacy student–led consultations have the potential to help patients manage their blood pressure (BP). Objective: The aim of this study was to assess the effectiveness, feasibility, and acceptability of SMS text messaging and consultation to manage the BP of Chinese patients with hypertension. Methods: We conducted a two-arm cluster randomized controlled trial among patients with hypertension in Xi’an City, Shaanxi Province, China, and recruited 384 patients from 8 community health care centers. Patients were randomized into an intervention group to receive SMS text messages and consultations or into a control group to receive usual care for 3 months. We sent SMS text messages at 3-day intervals and collected data at baseline (including demographics, clinical outcomes, medication complexity, side effects, patient behavior, knowledge about hypertension, BP, and medication adherence) and the 3-month follow-up (including BP, medication adherence, and knowledge about hypertension). Results: We assessed 445 patients with hypertension and excluded 61 patients who were not eligible or who had not filled out their questionnaires. The mean age of the patients was 68.5 (SD 7.9) years in the intervention group and 69.4 (SD 9.7) years in the control group, and the sample was primarily female (265/384, 69.0%). Patients in the intervention group showed significant improvements in systolic BP (SBP; mean 134.5 mm Hg, SD 15.5 mm Hg vs mean 140.7 mm Hg, SD 15.2 mm Hg; P=.001), medication adherence (mean 7.4, SD 1.2 vs mean 7.0, SD 1.3; P=.04), and knowledge about hypertension (mean 6.3, SD 0.9 vs mean 5.9, SD 1.2; P=.004) compared with those in the control group. In measures of diastolic BP (DBP), the two arms showed nonsignificant improvements (mean 78.2 mm Hg, SD 9.0 mm Hg vs mean 77.2 mm Hg, SD 10.3 mm Hg; P=.06). In total, 176 patients had controlled BP at the 3-month follow-up (98 patients in the intervention group vs 78 patients in the control group), but it was nonsignificant (P=.08). Conclusions: The use of SMS text messaging and consultation to manage SBP and improve medication adherence is effective, feasible, and acceptable among Chinese patients with hypertension, although a significant difference was not observed with regard to DBP. It is important to maximize the potential of SMS text messaging and consultation by increasing the feasibility and acceptance of mobile interventions and conduct a cost-effectiveness analysis on this method. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900026862; http://www.chictr.org.cn/showproj.aspx?proj=42717. %M 32432556 %R 10.2196/16019 %U https://www.jmir.org/2020/5/e16019 %U https://doi.org/10.2196/16019 %U http://www.ncbi.nlm.nih.gov/pubmed/32432556 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 5 %P e17824 %T Help to Overcome Problems Effectively for Cancer Survivors: Development and Evaluation of a Digital Self-Management Program %A Martin,Faith %A Wright,Hayley %A Moody,Louise %A Whiteman,Becky %A McGillion,Michael %A Clyne,Wendy %A Pearce,Gemma %A Turner,Andy %+ Faculty Research Centre for Intelligent Healthcare, Faculty of Health and Life Sciences, Coventry University, Priory Street, Coventry, CV1 5FB, United Kingdom, 44 02477657498, hsx116@coventry.ac.uk %K positive psychology %K self-management %K hope %K quality of life %K survivorship %K cancer %D 2020 %7 19.5.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: People living with cancer face numerous psychosocial challenges, including cancer-related fatigue, fear of recurrence, and depression. There is a lack of digital interventions tailored to the needs of people living with all types of cancer. We developed a 6-week, digital, peer-delivered, self-management program: iHOPE (Help to Overcome Problems Effectively; where ‘i’ indicates the digital version of the program). The program is underpinned by positive psychology and cognitive behavioral therapy to meet these psychosocial challenges. Objective: This study aimed to assess the feasibility of the iHOPE program among people living with cancer. Program adherence and satisfaction along with changes in psychological distress and positive well-being were measured. Methods: A pre-post, acceptability, and feasibility design was used. People living with cancer (N=114) were recruited via a national cancer charity in the United Kingdom and were given access to the iHOPE program. Demographic and other participant characteristics were recorded. Participants completed digital measures at baseline and the end of the 6-week program for depression, anxiety, cancer-related fatigue, cancer worry or fear of cancer recurrence, positive mental well-being, hope, gratitude, and health status. The website’s system recorded data on the usage of the program. Satisfaction with the program was also measured. Results: A total of 114 participants completed the baseline questionnaires. Of these, 70 people (61.4%) participated in all 6 sessions. The mean number of sessions undertaken was 5.0 (SD 1.5). Moreover, 44.7% (51/114) of participants completed at least three sessions and end-of-program outcome measures. A total of 59 participants completed the satisfaction questionnaire, where ≥90% (54/58) of participants reported that the program was easy to navigate and was well managed by the peer facilitators, and that they found the social networking tools useful. Preliminary efficacy testing among the 51 participants who completed baseline and postprogram outcome measures showed that postprogram scores decreased for depression, anxiety, cancer-related fatigue, and fear of recurrence (all P<.001) and increased for positive mental well-being (P<.001), hope (both P<.001), and gratitude (P=.02). Conclusions: The feasibility evidence is promising, showing that the peer-delivered digital iHOPE program is acceptable and practical. Implementation of the iHOPE program on a wider scale will incorporate further research and development to maximize the completion rates of the measures. Initial effectiveness data suggest positive impacts on important cancer-related quality of life and mental well-being outcomes. A randomized controlled trial design with a longer follow-up is needed to confirm the potential of the iHOPE program for improving mental and physical health outcomes for cancer survivors. %M 32209529 %R 10.2196/17824 %U http://www.jmir.org/2020/5/e17824/ %U https://doi.org/10.2196/17824 %U http://www.ncbi.nlm.nih.gov/pubmed/32209529 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 5 %P e16604 %T User Experiences of an Internet-Based Stepped-Care Intervention for Individuals With Cancer and Concurrent Symptoms of Anxiety or Depression (the U-CARE AdultCan Trial): Qualitative Study %A Igelström,Helena %A Hauffman,Anna %A Alfonsson,Sven %A Sjöström,Jonas %A Cajander,Åsa %A Johansson,Birgitta %+ Department of Neuroscience, Uppsala University, BMC, Box 593, Uppsala, 75124, Sweden, 46 184714761, helena.igelstrom@neuro.uu.se %K interactive web portal %K stepped care %K user experience %K cancer %K interviews %D 2020 %7 19.5.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: The internet-based stepped-care intervention iCAN-DO, used in the multicenter randomized controlled trial AdultCan, was developed for adult patients undergoing treatment for cancer and concurrently experiencing anxiety or depressive symptoms. iCAN-DO aimed to decrease symptoms of anxiety or depression. Step 1 comprises access to a library with psychoeducational material and a peer-support section, as well as the possibility to pose questions to a nurse. Step 2 of the intervention offers treatment consisting of internet-based cognitive behavioral therapy (iCBT) to participants still experiencing anxiety or depression at 1, 4, or 7 months after inclusion. Objective: The study aimed to explore user experiences of delivery, design, and structure of iCAN-DO from the perspective of people with cancer. Methods: We studied user experiences by interviewing 15 informants individually: 10 women with breast cancer (67%), 4 men with prostate cancer (27%), and 1 man with colorectal cancer (7%) with a mean age 58.9 years (SD 8.9). The interviews focused on informants' perceptions of ease of use and of system design and structure. Informants had been included in iCAN-DO for at least 7 months. They were purposefully selected based on activity in Step 1, participation in iCBT (ie, Step 2), gender, and diagnosis. Results: Of the 15 informants, 6 had been offered iCBT (40%). All informants used the internet on a daily basis, but 2 (13%) described themselves as very inexperienced computer users. The analysis revealed three subthemes, concerning how user experiences were affected by disease-specific factors and side effects (User experience in the context of cancer), technical problems (Technical struggles require patience and troubleshooting), and the structure and design of iCAN-DO (Appealing and usable, but rather simple). Conclusions: The results indicate that user experiences were affected by informants’ life situations, the technical aspects and the design of iCAN-DO, and informants’ preferences. The results have generated some developments feasible to launch during the ongoing study, but if iCAN-DO is to be used beyond research interest, a greater level of tailoring of information, features, and design may be needed to improve user experiences. The use of recurrent questionnaires during the treatment period may highlight an individual’s health, but also function as a motivator showing improvements over time. %M 32427108 %R 10.2196/16604 %U http://www.jmir.org/2020/5/e16604/ %U https://doi.org/10.2196/16604 %U http://www.ncbi.nlm.nih.gov/pubmed/32427108 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 5 %P e16629 %T A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness %A Kassavou,Aikaterini %A Mirzaei,Venus %A Brimicombe,James %A Edwards,Simon %A Massou,Efthalia %A Prevost,A Toby %A Griffin,Simon %A Sutton,Stephen %+ The University of Cambridge, Forvie Site, Robinson Way, Cambridge, CB2 0SR, United Kingdom, 44 1223330456, kk532@medschl.cam.ac.uk %K medication adherence %K hypertension %K type 2 diabetes %K text messaging %K interactive voice response %D 2020 %7 19.5.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated. Objective: This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored. Methods: This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement. Results: A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t116=2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI −7.423 to 6.301), and hemoglobin A1c was 4.5 mmol/mol (95% CI −13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction. Conclusions: Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149. %M 32427113 %R 10.2196/16629 %U http://www.jmir.org/2020/5/e16629/ %U https://doi.org/10.2196/16629 %U http://www.ncbi.nlm.nih.gov/pubmed/32427113 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 5 %P e16174 %T Mapping Canadian Men’s Recent and Intended Health Behavior Changes Through the Don’t Change Much Electronic Health Program %A Oliffe,John L %A Black,Nick %A Yiu,Jeffrey %A Flannigan,Ryan K %A McCreary,Donald R %A Goldenberg,S Larry %+ School of Nursing, Faculty of Applied Science, University of British Columbia, T201-2211 Wesbrook Mall, Vancouver, BC, V6T 2B5, Canada, 1 604 822 7638, john.oliffe@ubc.ca %K men’s e-Health %K men’s health behavior change %K men’s health promotion %D 2020 %7 15.5.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Although evaluation studies confirm the strong potential of men’s electronic health (eHealth) programs, there have been calls to more fully understand acceptability, engagement, and behavior change to guide future work. Relatedly, mapping of behavior changes using health promotion theories including the transtheoretical model (or stages of change) has been recommended to build a translatable empirical base to advance design and evaluation considerations for men’s eHealth programs. Objective: This study aimed to use a benchmark sample as a reference group to map the recent and intended health behavior changes in Canadian men who use the Don’t Change Much (DCM) eHealth program. The hypothesis being tested was that increased exposure to DCM would be positively associated with men’s recent and intended health behavior changes. Methods: DCM users (n=863) were sampled for demographic data and self-reported recent and intended health behavior changes. Respondents also reported their usage (frequency and duration) for each of the 3 DCM components (web, newsletter, and social media) and were allocated to limited exposure (257/863, 29.8%), low exposure (431/863, 49.9%), and high exposure (175/863, 20.3%) subgroups. A benchmark sample (n=2000), comprising respondents who had not accessed DCM provided a reference group. Bivariate analysis of recent and intended health behavior changes and DCM exposure levels were used to compute the strength of association between the independent variables (exposure levels) and the 10 categorical dependent variables (recent and intended health behavior changes). Binary logistic regression models were computed for each of the 10 recent and intended health behavior changes. Linear regression was used to model the association between the number of recent and intended changes and the level of exposure to DCM. Results: Compared with the benchmark reference group, DCM high-exposure respondents had significantly increased odds for 9 of the 10 health behavior changes, with the largest effect size observed for Changed diet or Improved eating habits (odds ratio [OR] 5.628, 95% CI 3.932-8.055). High-exposure respondents also had significantly increased odds for 9 intended health changes, with the largest effect sizes observed for Reduce stress level (OR 4.282, 95% CI 3.086-5.941). Moderate effect size (goodness of fit) was observed for increased total number of recent (F12,2850=25.52; P.001; adjusted R2=.093) and intended health behavior changes (F12,2850=36.30; P.001; adjusted R2=.129) among high-exposure respondents. Conclusions: DCM respondents contrasted the predominately precontemplative benchmark sample mapping across the contemplative, preparation, and action stages of the transtheoretical health behavior change model. Almost 10% of variation in the recent and 13% of variation in the intended health behavior changes can be explained by DCM exposure and demographic factors, indicating the acceptability of this men’s eHealth resource. %M 32412423 %R 10.2196/16174 %U https://www.jmir.org/2020/5/e16174 %U https://doi.org/10.2196/16174 %U http://www.ncbi.nlm.nih.gov/pubmed/32412423 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 5 %P e15895 %T The Development of a Web-Based, Patient-Centered Intervention for Patients With Chronic Myeloid Leukemia (CMyLife): Design Thinking Development Approach %A Ector,Geneviève ICG %A Westerweel,Peter E %A Hermens,Rosella PMG %A Braspenning,Karin AE %A Heeren,Barend CM %A Vinck,Oscar MF %A de Jong,Jan JM %A Janssen,Jeroen JWM %A Blijlevens,Nicole MA %+ Department of Hematology, Radboud University Medical Center, Geert Grooteplein Zuid 8, Nijmegen, 6500 Hb, Netherlands, 31 243618810, genevieve.ector@radboudumc.nl %K eHealth %K chronic myeloid leukemia %K patient participation %K mobile apps %D 2020 %7 15.5.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: With the global rise in chronic health conditions, health care is transforming, and patient empowerment is being emphasized to improve treatment outcomes and reduce health care costs. Patient-centered innovations are needed. We focused on patients with chronic myeloid leukemia (CML), a chronic disease with a generally good long-term prognosis because of the advent of tyrosine kinase inhibitors. However, both medication adherence by patients and guideline adherence by physicians are suboptimal, unnecessarily jeopardizing treatment outcomes. Objective: The aim of this study was to develop a patient-centered innovation for patients with CML using a design thinking methodology. Methods: The 5 phases of design thinking (ie, empathize, define, ideate, prototype, and test) were completed, and each phase started with the patient. Stakeholders and end users were identified and interviewed, and observations in the care system were made. Using tools in human-centered design, problems were defined and various prototypes of solutions were generated. These were evaluated by patients and stakeholders and then further refined. Results: The patients desired (1) insights into their own disease; (2) insights into the symptoms experienced, both in terms of knowledge and comprehension; and (3) improvements in the organization of care delivery. A web-based platform, CMyLife, was developed and pilot-tested. It has multiple features, all targeting parts of the bigger solution, including a website with reliable information and a forum, a guideline app, personal medical records with logs of symptoms and laboratory results (including a molecular marker and linked to the guideline app), tailored feedback based on the patients’ symptoms and/or results, screen-to-screen consulting, delivery of medication, and the collection of blood samples at home. Conclusions: The multifeatured innovation, CMyLife, was developed in a multidisciplinary way and with active patient participation. The aim of developing CMyLife was to give patients the tools to monitor their results, interpret these results, and act on them. With this tool, they are provided with the know-how to consider their results in relation to their personal care process. Whether CMyLife achieves its goal and the evaluation of the added value will be the focus of future studies. CML could become the first malignancy for which patients are able to monitor and manage their disease by themselves. %M 32412424 %R 10.2196/15895 %U https://www.jmir.org/2020/5/e15895 %U https://doi.org/10.2196/15895 %U http://www.ncbi.nlm.nih.gov/pubmed/32412424 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 5 %P e15773 %T A Mobile App Lifestyle Intervention to Improve Healthy Nutrition in Women Before and During Early Pregnancy: Single-Center Randomized Controlled Trial %A van Dijk,Matthijs R %A Koster,Maria P H %A Oostingh,Elsje C %A Willemsen,Sten P %A Steegers,Eric A P %A Steegers-Theunissen,Régine P M %+ Department of Obstetrics and Gynaecology, Erasmus Medical Center, University Medical Center Rotterdam, PO Box 2040, Rotterdam, Netherlands, 31 107038254, r.steegers@erasmusmc.nl %K mHealth %K preconception care %K nutrition %K pregnancy %D 2020 %7 15.5.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Unhealthy nutrition contributes to the worldwide rising prevalence of noncommunicable diseases. As most adverse reproductive outcomes originate during the periconception period, effective interventions targeting this period are needed. Therefore, we developed the lifestyle intervention Smarter Pregnancy to empower women to adapt a healthy diet prior to conception and during early pregnancy and performed a randomized controlled trial. Objective: The objectives of this trial were to investigate compliance and effectiveness in women using the Smarter Pregnancy program. Methods: Women aged between 18 and 45 years who were contemplating pregnancy or <13 weeks pregnant and their male partners living in the urban area of Rotterdam, the Netherlands, were eligible for participation. After baseline screening, the intervention group received personal online coaching based on identified inadequate intakes of vegetables, fruits, and folic acid supplements. The sum of these risk factors was used as a dietary risk score (DRS), ranging from 0 (healthy) to 9 (unhealthy). The control group did not receive coaching. We applied an intention-to-treat principle and used a multivariable linear regression model to evaluate the change in DRS after 24 weeks. Compliance was defined as the percentage of women who completed the screening questionnaire at 24 weeks. Results: Of women recruited, 81.2% (177/218) completed the program (intervention: 91/218, 83.5%; control: 86/218, 78.9%; P=.95). After 24 weeks, the reduction in DRS of women in the intervention group was significantly larger than in the control group (β=.75, 95% CI 0.18-1.34). This reduction was mainly due to increased vegetable intake (β=.55, 95% CI 0.25-0.86). Conclusions: The high compliance and the larger improvements in nutritional behaviors, especially vegetable intake, in women in the intervention group emphasizes the effectiveness of empowering women by using the lifestyle change intervention Smarter Pregnancy. Trial Registration: Netherlands Trial Register: NL3927; https://www.trialregister.nl/trial/3927 International Registered Report Identifier (IRRID): RR2-10.1186/s12884-017-1228-5 %M 32412417 %R 10.2196/15773 %U https://www.jmir.org/2020/5/e15773 %U https://doi.org/10.2196/15773 %U http://www.ncbi.nlm.nih.gov/pubmed/32412417 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 5 %P e17018 %T Web-Based Self-Management for Patients With Lymphoma: Assessment of the Reach of Intervention of a Randomized Controlled Trial %A Arts,Lindy P J %A Oerlemans,Simone %A Posthuma,Eduardus F M %A Issa,Djamila E %A Oosterveld,Margriet %A van der Griend,René %A Nijziel,Marten R %A van de Poll-Franse,Lonneke V %+ Netherlands Comprehensive Cancer Organisation, Godebaldkwartier 419, Utrecht, 3511DT, Netherlands, 31 882346000, s.oerlemans@iknl.nl %K reach %K uptake %K participation, web-based intervention %K pragmatic %K randomized controlled trial %K population-based registry %K lymphoma %D 2020 %7 14.5.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Randomized controlled trials (RCTs) often provide accurate estimates of the internal validity of an intervention but lack information on external validity (generalizability). We conducted an RCT on the effectiveness of a self-management intervention among patients with lymphoma in a population-based setting. Objective: The objectives of the current study were to describe the proportion of RCT participants compared to all patients invited to participate, and compare sociodemographic and clinical characteristics of RCT participants with all respondents, all patients invited to participate, and all patients selected from the Netherlands Cancer Registry (NCR) to determine the reach of the intervention. An additional objective was to assess differences on RCT outcome variables between RCT and paper respondents. Methods: Patients with lymphoma or chronic lymphocytic leukemia ≥18 years old at diagnosis from 13 hospitals in the Netherlands were selected from the population-based NCR, which routinely collects data on sociodemographic and clinical characteristics. Eligible patients were invited to participate in an RCT and complete a questionnaire. Web-based completion determined RCT enrollment, whereas paper respondents were followed observationally. Results: A total of 1193 patients were selected from the NCR, 892 (74.77%) of whom were invited to participate in the trial by their hematologist after verifying eligibility. Among those invited, 25.4% (227/892) completed the web-based questionnaire and were enrolled in the RCT. The RCT participants were younger and there was a higher proportion of men than nonparticipants (P<.001). In addition, 25.7% (229/892) of those invited opted to participate in the paper-based observational follow-up study. Compared with paper respondents, RCT participants were younger (P<.001), with a higher proportion of men (P=.002), and had higher education levels (P=.02). RCT participants more often wanted to receive all available information on their disease (P<.001), whereas paper respondents reported higher levels of emotional distress (P=.009). Conclusions: From a population-based sample of eligible patients, the participation rate in the RCT was approximately 25%. RCT participants may not be representative of the target population because of different sociodemographic and clinical characteristics. Since RCT participants represent a minority of the target population, RCT results should be interpreted with caution as patients in the RCT may be those least in need of a self-management intervention. Trial Registration: Netherlands Trial Register NTR5953; https://www.trialregister.nl/trial/5790 %M 32406858 %R 10.2196/17018 %U http://www.jmir.org/2020/5/e17018/ %U https://doi.org/10.2196/17018 %U http://www.ncbi.nlm.nih.gov/pubmed/32406858 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 5 %P e15562 %T Gratitude at Work: Prospective Cohort Study of a Web-Based, Single-Exposure Well-Being Intervention for Health Care Workers %A Adair,Kathryn C %A Rodriguez-Homs,Larissa G %A Masoud,Sabran %A Mosca,Paul J %A Sexton,J Bryan %+ Duke Center for Healthcare Safety and Quality, Duke University Health System, University Tower, Suite 300, 3100 Tower Blvd, Durham, NC, 27707, United States, 1 9196686812, kathryn.c.adair@duke.edu %K burnout %K health care %K positive psychology %K mental health %K emotions %D 2020 %7 14.5.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Emotional exhaustion (EE) in health care workers is common and consequentially linked to lower quality of care. Effective interventions to address EE are urgently needed. Objective: This randomized single-exposure trial examined the efficacy of a gratitude letter–writing intervention for improving health care workers’ well-being. Methods: A total of 1575 health care workers were randomly assigned to one of two gratitude letter–writing prompts (self- vs other focused) to assess differential efficacy. Assessments of EE, subjective happiness, work-life balance, and tool engagement were collected at baseline and 1-week post intervention. Participants received their EE score at baseline and quartile benchmarking scores. Paired-samples t tests, independent t tests, and correlations explored the efficacy of the intervention. Linguistic Inquiry and Word Count software assessed the linguistic content of the gratitude letters and associations with well-being. Results: Participants in both conditions showed significant improvements in EE, happiness, and work-life balance between the intervention and 1-week follow-up (P<.001). The self-focused (vs other) instruction conditions did not differentially predict improvement in any of the measures (P=.91). Tool engagement was high, and participants reporting higher motivation to improve their EE had higher EE at baseline (P<.001) and were more likely to improve EE a week later (P=.03). Linguistic analyses revealed that participants high on EE at baseline used more negative emotion words in their letters (P=.005). Reduction in EE at the 1-week follow-up was predicted at the level of a trend by using fewer first-person (P=.06) and positive emotion words (P=.09). No baseline differences were found between those who completed the follow-up assessment and those who did not (Ps>.05). Conclusions: This single-exposure gratitude letter–writing intervention appears to be a promising low-cost, brief, and meaningful tool to improve the well-being of health care workers. %M 32406864 %R 10.2196/15562 %U https://www.jmir.org/2020/5/e15562 %U https://doi.org/10.2196/15562 %U http://www.ncbi.nlm.nih.gov/pubmed/32406864 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 5 %P e15989 %T Use of Brief Messages Based on Behavior Change Techniques to Encourage Medication Adherence in People With Type 2 Diabetes: Developmental Studies %A Bartlett,Yvonne Kiera %A Farmer,Andrew %A Rea,Rustam %A French,David P %+ Manchester Centre for Health Psychology, University of Manchester, Coupland 1 Building, Oxford Road, Manchester, United Kingdom, 44 161 306 5436, kiera.bartlett@manchester.ac.uk %K behavior change %K behavior change techniques %K type 2 diabetes, brief messages %K mHealth %K medication adherence %D 2020 %7 13.5.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Brief messages are a promising way to improve adherence to medication for people with type 2 diabetes. However, it is often unclear how messages have been developed and their precise content, making it difficult to ascertain why certain messages are successful and some are not. Objective: The goal of the research was to develop messages that have proven fidelity to specified evidence-derived behavior change techniques (BCTs) and are acceptable to people with type 2 diabetes. Methods: Four studies were conducted: (1) a workshop (n=21) where behavioral change researchers and health care professionals developed messages based on specific BCTs or beliefs or concerns related to taking medication, (2) a focus group study with people with type 2 diabetes (n=23) to assess acceptability of the approach, (3) a survey to ascertain the acceptability of a subset of messages to people with type 2 diabetes (n=61) and, (4) a survey with behavior change researchers to assess the fidelity of a subset of messages to their intended BCT (n=18). Results: In study 1, 371 messages based on 38 BCTs and beliefs/concerns were developed. Workshop participants rated BCTs to be relevant to medication adherence (mean 7.12/10 [SD 1.55]) and messages to have good fidelity (mean 7.42/10 [SD 1.19]). In study 2, the approach of providing medication adherence support through text messages was found to be acceptable. In study 3, mean acceptability of all BCTs was found to be above the midpoint (mean 3.49/5 [SD 0.26]). In study 4, mean fidelity for all BCTs was found to be above the midpoint (mean 7.61/10 [SD 1.38]). Conclusions: A library of brief messages acceptable to people with type 2 diabetes and representative of specific evidence-derived BCTs was developed. This approach allowed brief messages to be developed with known content that can be used to test theory. %M 32401214 %R 10.2196/15989 %U https://www.jmir.org/2020/5/e15989 %U https://doi.org/10.2196/15989 %U http://www.ncbi.nlm.nih.gov/pubmed/32401214 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 7 %N 5 %P e16342 %T Combining Web-Based Attentional Bias Modification and Approach Bias Modification as a Self-Help Smoking Intervention for Adult Smokers Seeking Online Help: Double-Blind Randomized Controlled Trial %A Wen,Si %A Larsen,Helle %A Boffo,Marilisa %A Grasman,Raoul P P P %A Pronk,Thomas %A van Wijngaarden,Joeri B G %A Wiers,Reinout W %+ Department of Psychology, University of Amsterdam, Nieuwe Achtergracht 129B, Amsterdam, 1001NK, Netherlands, 31 684128489, si-wen@hotmail.com %K cognitive bias modification %K attentional bias modification %K approach bias modification %K Web-based intervention %K smoking addiction %K smoking cessation %K eHealth %K randomized controlled trial %D 2020 %7 8.5.2020 %9 Original Paper %J JMIR Ment Health %G English %X Background: Automatically activated cognitive motivational processes such as the tendency to attend to or approach smoking-related stimuli (ie, attentional and approach bias) have been related to smoking behaviors. Therefore, these cognitive biases are thought to play a role in maintaining smoking behaviors. Cognitive biases can be modified with cognitive bias modification (CBM), which holds promise as an easy-access and low-cost online intervention. However, little is known about the effectiveness of online interventions combining two varieties of CBM. Targeting multiple cognitive biases may improve treatment outcomes because these biases have been shown to be relatively independent. Objective: This study aimed to test the individual and combined effects of two web-based CBM varieties—attentional bias modification (AtBM) and approach bias modification (ApBM)—in a double-blind randomized controlled trial (RCT) with a 2 (AtBM: active versus sham) × 2 (ApBM: active versus sham) factorial design. Methods: A total of 504 adult smokers seeking online help to quit smoking were randomly assigned to 1 of 4 experimental conditions to receive 11 fully automated CBM training sessions. To increase participants’ intrinsic motivation to change their smoking behaviors, all participants first received brief, automated, tailored feedback. The primary outcome was point prevalence abstinence during the study period. Secondary outcomes included daily cigarette use and attentional and approach bias. All outcomes were repeatedly self-assessed online from baseline to the 3-month follow-up. For the examination of training effects on outcome changes, an intention-to-treat analysis with a multilevel modeling (MLM) approach was adopted. Results: Only 10.7% (54/504) of the participants completed all 11 training sessions, and 8.3% (42/504) of the participants reached the 3-month follow-up assessment. MLM showed that over time, neither AtBM or ApBM nor a combination of both differed from their respective sham training in point prevalence abstinence rates (P=.17, P=.56, and P=.14, respectively), and in changes in daily cigarette use (P=.26, P=.08, and P=.13, respectively), attentional bias (P=.07, P=.81, and P=.15, respectively), and approach bias (P=.57, P=.22, and P=.40, respectively), while daily cigarette use decreased over time across conditions for all participants (P<.001). Conclusions: This RCT provides no support for the effectiveness of combining AtBM and ApBM in a self-help web-based smoking cessation intervention. However, this study had a very high dropout rate and a very low frequency of training usage, indicating an overall low acceptability of the intervention, which precludes any definite conclusion on its efficacy. We discuss how this study can inform future designs and settings of online CBM interventions. Trial Registration: Netherlands Trial Register NTR4678; https://www.trialregister.nl/trial/4678 %M 32383682 %R 10.2196/16342 %U https://mental.jmir.org/2020/5/e16342 %U https://doi.org/10.2196/16342 %U http://www.ncbi.nlm.nih.gov/pubmed/32383682 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 5 %P e14617 %T Web-Based Intervention Effects on Mild Cognitive Impairment Based on Apolipoprotein E Genotype: Quasi-Experimental Study %A Tsolaki,Anthoula C %A Tsolaki,Magda %A Pandria,Niki %A Lazarou,Eftychia %A Gkatzima,Olymbia %A Zilidou,Vasiliki %A Karagianni,Maria %A Iakovidou-Kritsi,Zafiroula %A Kimiskidis,Vasilios K %A Bamidis,Panagiotis D %+ Medical Physics Laboratory, School of Medicine, Aristotle University of Thessaloniki, PO Box 376, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece, 30 2310999310, pdbamidis@gmail.com %K mild cognitive impairment %K APOE ε4 %K computerized training %K exergaming %K Alzheimer disease %D 2020 %7 7.5.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Apolipoprotein E (APOE) ε4 allele is a major genetic risk factor for Alzheimer disease and mild cognitive impairment (MCI). Computer-based training programs can improve cognitive performance in elderly populations. However, the effects of computer-based interventions on MCI APOE ε4 carriers have never been studied before. Objective: The effects of different web-based interventions and the APOE isoform-specific differences in training outcomes are investigated. Methods: Using a quasi-experimental study design, 202 participants with MCI aged 60 years and older took part in three different intervention programs (physical and cognitive [Long-Lasting Memories, or LLM], cognitive [Active Control, or AC], or physical intervention [Physical Training Control, or PTC]) via an innovative information and communication technologies exergaming platform. Participants in each interventional group were subdivided into APOE ε4 carriers and non–APOE ε4 carriers. All participants underwent an extensive neuropsychological evaluation before and after the training, blood tests, and brain imaging. Results: All interventions resulted in multiple statistically significant cognitive benefits after the intervention. Verbal learning (California Verbal Learning Test: immediate recall test score—LLM: P=.04; AC: P<.001), working memory (digit span forward and backward test scores—AC: P=.03; PTC: P=.02 and P=.006, respectively), and long-term memory (California Verbal Learning Test: delayed recall test score—LLM: P=.02; AC: P=.002; and PTC: P=.02) were improved. There was no statistically significant difference among the intervention effects. APOE ε4 presence moderates intervention effects as the LLM intervention improved only their task-switching processing speed (Trail Making Test, Part B: P=.03) and the PTC intervention improved only the working memory (digit span backward: P=.03). No significant performance alteration was noted for the APOE ε4+ cognitive AC training group. Conclusions: None of the applied interventions could be identified as the optimal one; it is suggested, however, that combined cognitive and physical training and physical training via exergaming may be more effective for the high-risk MCI ΑPOE ε4+ subgroup. %M 32379048 %R 10.2196/14617 %U https://www.jmir.org/2020/5/e14617 %U https://doi.org/10.2196/14617 %U http://www.ncbi.nlm.nih.gov/pubmed/32379048 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 5 %P e13980 %T A Facilitated Web-Based Self-Management Tool for People With Type 1 Diabetes Using an Insulin Pump: Intervention Development Using the Behavior Change Wheel and Theoretical Domains Framework %A Reidy,Claire %A Foster,Claire %A Rogers,Anne %+ National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care, School of Health Sciences, Faculty of Environmental & Life Sciences, University of Southampton, University Road, Southampton, SO17 1BJ, United Kingdom, 44 23 8059 7628, c.reidy@soton.ac.uk %K web-based intervention %K behavior change wheel %K type 1 diabetes %K social support %K continuous subcutaneous insulin infusion %K self-management %D 2020 %7 1.5.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Type 1 diabetes (T1D) requires intensive self-management (SM). An insulin pump is designed to better support personal T1D management, but at the same time, it exacerbates the complexity and requirements of SM. Research shows that people with diabetes are likely to benefit from navigating and connecting to local means of social support and resources through web-based interventions that offer flexible, innovative, and accessible SM. However, questions remain as to which behavior change mechanisms within such resources benefit patients most and how to foster engagement with and endorsement of SM interventions. Objective: The aim of this study was to evaluate the perspectives and experiences of people with T1D using an insulin pump and specialist health care professionals (HCPs) and determine what behavior change characteristics and strategies are required to inform the optimization of an existing web-based social network (SN) intervention to support SM. Methods: Focus groups with insulin pump users (n=19) and specialist HCPs (n=20) in 6 National Health Service (NHS) trusts across the south of England examined the barriers and enablers to incorporating and self-managing an insulin pump. An analysis was undertaken using the Behavior Change Wheel and Theoretical Domains Framework, followed by a taxonomy of behavior change techniques (BCTs) to identify the contents of and strategies for the implementation of a complex health intervention. Results: A total of 4 themes represent the SM perspectives and experiences of stakeholders: (1) a desire for access to tailored and appropriate resources and information—the support and information required for successful SM are situational and contextual, and these vary according to time and life circumstances, and therefore, these need to be tailored and appropriate; (2) specific social support preferences—taking away isolation as well as providing shared learnings and practical tips, but limitations included the fear of judgment from others and self-pity from peers; (3) the environmental context, that is, capacity and knowledge of pump clinic HCPs—HCPs acknowledge the patient’s need for holistic support but lack confidence in providing it; and (4) professional responsibility and associated risks and dangers, whereas HCPs are fearful of the consequences of promoting non-NHS SM support, and they question whether SM support fits into their role. BCTs were identified to address these issues. Conclusions: The use of behavioral theory and a validated implementation framework provided a comprehensive approach for systematically identifying barriers and enablers of self-managing T1D with an insulin pump. A web-based SN intervention appears to offer additional forms of SM support while complementing NHS services. However, for intervention implementation, HCPs’ apprehensions about responsibility when signposting to non-NHS SM support would need to be addressed, and opportunistic features would need to be added, through which pump users could actively engage with other people living with T1D. %M 32356776 %R 10.2196/13980 %U https://www.jmir.org/2020/5/e13980 %U https://doi.org/10.2196/13980 %U http://www.ncbi.nlm.nih.gov/pubmed/32356776 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 4 %P e15587 %T Message Delivery for the Treatment of Posttraumatic Stress Disorder: Longitudinal Observational Study of Symptom Trajectories %A Malgaroli,Matteo %A Hull,Thomas Derrick %A Wiltsey Stirman,Shannon %A Resick,Patricia %+ NYU Grossman School of Medicine, One Park Avenue, 8th Floor, New York, NY, 10016, United States, 1 6467544030, matteo.malgaroli@nyulangone.org %K PTSD %K telemedicine %K messaging %K textmessaging %K psychotherapy %K telehealth %K digital health %D 2020 %7 29.4.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Individuals with posttraumatic stress disorder (PTSD) face symptoms that can hinder access to treatment, such as avoidance and guilt. Telemedicine offers a technological solution to increase access to mental health care and overcome barriers to treatment. Although an increasing body of literature focused on synchronous telehealth (eg, live video), no studies have examined the delivery of PTSD treatment via two-way multimedia messages (ie, texting or messaging). Objective: The aim of this study was to conduct a longitudinal observation of treatment for PTSD delivered using two-way asynchronous messaging. We also sought to identify individual and treatment characteristics that could predict the observed outcome differences. Methods: Outpatients diagnosed with PTSD (N=475) received interventions from licensed therapists, which were delivered via messaging once or more than once per day, 5 days a week for 12 weeks. PTSD symptoms were assessed every 3 weeks using the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5. Trajectories of PTSD symptoms were identified using growth mixture modeling (GMM). Using logistic regression, the demographic, treatment, and messaging characteristics of patient groups that improved were compared with the characteristics of patient groups that did not improve. Results: The GMM identified 4 trajectories of PTSD symptoms: moderate improvement (197/475, 41.4%), high symptoms (197/475, 41.4%), chronic symptoms (61/475, 12.9%), and acute improvement (20/475, 4.3%). Patients with a clinically significant reduction in PTSD symptoms (231/475, 48.6%) were more likely to communicate via video (odds ratio [OR] 1.01, 95% CI 1.01-1.05; P=.03), have a higher working alliance with their therapist (OR 1.03, 95% CI 1.01-1.05; P=.02), and be at their first treatment experience (OR 2.03, 95% CI 1.18-3.54; P=.01). Treatment adherence was associated with greater therapeutic alliance (OR 1.07, 95% CI 1.03-1.10; P<.001), education (OR 2.13, 95% CI 1.13-4.03; P=.02), and more patient-generated messages per week (OR 1.08, 95% CI 1.04-1.13; P<.001). Conclusions: Multimedia message delivery for PTSD treatment showed symptom-reduction rates similar to traditional forms of treatment delivery, suggesting further study of messaging as a treatment medium. Most patients completed an 8-week course, reflecting the acceptability of messaging interventions. Delivering treatment via two-way messaging offers increased opportunities for widespread access to mental health care. %M 32347814 %R 10.2196/15587 %U http://www.jmir.org/2020/4/e15587/ %U https://doi.org/10.2196/15587 %U http://www.ncbi.nlm.nih.gov/pubmed/32347814 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 4 %P e17530 %T A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation: Randomized Controlled Trial %A Carrasco-Hernandez,Laura %A Jódar-Sánchez,Francisco %A Núñez-Benjumea,Francisco %A Moreno Conde,Jesús %A Mesa González,Marco %A Civit-Balcells,Antón %A Hors-Fraile,Santiago %A Parra-Calderón,Carlos Luis %A Bamidis,Panagiotis D %A Ortega-Ruiz,Francisco %+ Research and Innovation Group in Biomedical Informatics, Biomedical Engineering and Health Economy, Institute of Biomedicine of Seville, Virgen del Rocío University Hospital, Spanish National Research Council, University of Seville, Avenida Manuel Siurot S/N, Seville, 41013, Spain, 34 670943651, francisco.jodar@juntadeandalucia.es %K smoking cessation %K behavioral change %K health recommender systems %K mHealth %K randomized controlled trial %D 2020 %7 27.4.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Smoking cessation is a persistent leading public health challenge. Mobile health (mHealth) solutions are emerging to improve smoking cessation treatments. Previous approaches have proposed supporting cessation with tailored motivational messages. Some managed to provide short-term improvements in smoking cessation. Yet, these approaches were either static in terms of personalization or human-based nonscalable solutions. Additionally, long-term effects were neither presented nor assessed in combination with existing psychopharmacological therapies. Objective: This study aimed to analyze the long-term efficacy of a mobile app supporting psychopharmacological therapy for smoking cessation and complementarily assess the involved innovative technology. Methods: A 12-month, randomized, open-label, parallel-group trial comparing smoking cessation rates was performed at Virgen del Rocío University Hospital in Seville (Spain). Smokers were randomly allocated to a control group (CG) receiving usual care (psychopharmacological treatment, n=120) or an intervention group (IG) receiving psychopharmacological treatment and using a mobile app providing artificial intelligence–generated and tailored smoking cessation support messages (n=120). The secondary objectives were to analyze health-related quality of life and monitor healthy lifestyle and physical exercise habits. Safety was assessed according to the presence of adverse events related to the pharmacological therapy. Per-protocol and intention-to-treat analyses were performed. Incomplete data and multinomial regression analyses were performed to assess the variables influencing participant cessation probability. The technical solution was assessed according to the precision of the tailored motivational smoking cessation messages and user engagement. Cessation and no cessation subgroups were compared using t tests. A voluntary satisfaction questionnaire was administered at the end of the intervention to all participants who completed the trial. Results: In the IG, abstinence was 2.75 times higher (adjusted OR 3.45, P=.01) in the per-protocol analysis and 2.15 times higher (adjusted OR 3.13, P=.002) in the intention-to-treat analysis. Lost data analysis and multinomial logistic models showed different patterns in participants who dropped out. Regarding safety, 14 of 120 (11.7%) IG participants and 13 of 120 (10.8%) CG participants had 19 and 23 adverse events, respectively (P=.84). None of the clinical secondary objective measures showed relevant differences between the groups. The system was able to learn and tailor messages for improved effectiveness in supporting smoking cessation but was unable to reduce the time between a message being sent and opened. In either case, there was no relevant difference between the cessation and no cessation subgroups. However, a significant difference was found in system engagement at 6 months (P=.04) but not in all subsequent months. High system appreciation was reported at the end of the study. Conclusions: The proposed mHealth solution complementing psychopharmacological therapy showed greater efficacy for achieving 1-year tobacco abstinence as compared with psychopharmacological therapy alone. It provides a basis for artificial intelligence–based future approaches. Trial Registration: ClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/NCT03553173 International Registered Report Identifier (IRRID): RR2-10.2196/12464 %M 32338624 %R 10.2196/17530 %U http://mhealth.jmir.org/2020/4/e17530/ %U https://doi.org/10.2196/17530 %U http://www.ncbi.nlm.nih.gov/pubmed/32338624 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 7 %N 4 %P e17157 %T Long-Term Effectiveness and Cost-Effectiveness of Videoconference-Delivered Cognitive Behavioral Therapy for Obsessive-Compulsive Disorder, Panic Disorder, and Social Anxiety Disorder in Japan: One-Year Follow-Up of a Single-Arm Trial %A Matsumoto,Kazuki %A Hamatani,Sayo %A Nagai,Kazue %A Sutoh,Chihiro %A Nakagawa,Akiko %A Shimizu,Eiji %+ Research Center for Child Mental Development, Chiba University, Inohana 1-8-1, Chuo-ku, Chiba, , Japan, 81 08 043 226 2975, axpa0219@chiba-u.jp %K long-term effectiveness %K cost-effectiveness %K videoconference-delivered cognitive behavioral therapy %K internet-based cognitive behavioral therapy %K obsessive-compulsive disorder %K panic disorder %K social anxiety disorder %D 2020 %7 23.4.2020 %9 Original Paper %J JMIR Ment Health %G English %X Background: Face-to-face individual cognitive behavioral therapy (CBT) and internet-based CBT (ICBT) without videoconferencing are known to have long-term effectiveness for obsessive-compulsive disorder (OCD), panic disorder (PD), and social anxiety disorder (SAD). However, videoconference-delivered CBT (VCBT) has not been investigated regarding its long-term effectiveness and cost-effectiveness. Objective: The purpose of this study was to investigate the long-term effectiveness and cost-effectiveness of VCBT for patients with OCD, PD, or SAD in Japan via a 1-year follow-up to our previous 16-week single-arm study. Methods: Written informed consent was obtained from 25 of 29 eligible patients with OCD, PD, and SAD who had completed VCBT in our clinical trial. Participants were assessed at baseline, end of treatment, and at the follow-up end points of 3, 6, and 12 months. Outcomes were the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), Panic Disorder Severity Scale (PDSS), Liebowitz Social Anxiety Scale (LSAS), Patient Health Questionnaire–9 (PHQ-9), General Anxiety Disorder–7 (GAD-7), and EuroQol-5D-5L (EQ-5D-5L). To analyze long-term effectiveness, we used mixed-model analysis of variance. To analyze cost-effectiveness, we employed relevant public data and derived data on VCBT implementation costs from Japanese national health insurance data. Results: Four males and 21 females with an average age of 35.1 (SD 8.6) years participated in the 1-year follow-up study. Principal diagnoses were OCD (n=10), PD (n=7), and SAD (n=8). The change at 12 months on the Y-BOCS was −4.1 (F1=4.45, P=.04), the change in PDSS was −4.4 (F1=6.83, P=.001), and the change in LSAS was −30.9 (F1=6.73, P=.01). The change in the PHQ-9 at 12 months was −2.7 (F1=7.72, P=.007), and the change in the GAD-7 was −3.0 (F1=7.09, P=.009). QALY at 12 months was 0.7469 (SE 0.0353, 95% Cl 0.6728-0.821), and the change was a significant increase of 0.0379 (P=.01). Total costs to provide the VCBT were ¥60,800 to ¥81,960 per patient. The set threshold was ¥189,500 ($1723, €1579, and £1354) calculated based on willingness to pay in Japan. Conclusions: VCBT was a cost-effective way to effectively treat Japanese patients with OCD, PD, or SAD. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000026609; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030495 %M 32324150 %R 10.2196/17157 %U http://mental.jmir.org/2020/4/e17157/ %U https://doi.org/10.2196/17157 %U http://www.ncbi.nlm.nih.gov/pubmed/32324150 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 4 %P e17688 %T Online Interventions for the Selective Prevention of Illicit Drug Use in Young Drug Users: Exploratory Study %A Tomazic,Tina %A Jerkovic,Olivera Stanojevic %+ Institute of Media Communications, Faculty of Electrical Engineering and Computer Science, University of Maribor, Koroska 46, Maribor, 2000, Slovenia, 386 41704302, tina.tomazic@um.si %K web-based %K intervention %K prevention %K internet %D 2020 %7 22.4.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital technologies have a major impact on the daily lives of young people and are also used to seek information on and help with drug-related issues online. Objective: The aim of this article was to analyze current online interventions for young drug users in Slovenia, with the purpose of contributing to the development of guidelines and key recommendations for effective online interventions. Methods: This study was part of the project Click for Support. We performed a keyword search, received input from national experts in the field of drug prevention, and conducted an assessment of recognized national online interventions through workshop-based discussions with the target group of 20 young drug users. Results: The current online intervention services in Slovenia are satisfactory but are still not sufficiently recognized. The most important issues for young drug users were the design and functionality of the online intervention, presence of a clear structure, possibility of using it on smartphones, comprehensive and quick professional feedback, and data security. Playful elements and the ability to share (experiences) with other or former users were also recognized as important. Conclusions: With effective online interventions, we can include more young drug users, facilitate access to a more affordable service, provide quick professional feedback on patterns of consumption, increase knowledge about the effects and consequences of drugs, and support the reduction or cessation of drug use. From the public health perspective, it is challenging to provide drug interventions broadly to the target group and, hence, decrease inequities. %M 32319962 %R 10.2196/17688 %U http://www.jmir.org/2020/4/e17688/ %U https://doi.org/10.2196/17688 %U http://www.ncbi.nlm.nih.gov/pubmed/32319962 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 4 %P e17089 %T Evaluating an Intervention Program Using WeChat for Patients With Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial %A Jiang,Yuyu %A Liu,Fenglan %A Guo,Jianlan %A Sun,Pingping %A Chen,Zhongyi %A Li,Jinping %A Cai,Liming %A Zhao,Hongqing %A Gao,Ping %A Ding,Zhaosheng %A Wu,Xiaoliang %+ Research Office of Chronic Disease Management and Rehabilitation, Wuxi School of Medicine, Jiangnan University, No 1800 Lihu Avenue, Wuxi, China, 86 0510 85328363, doctoryuyu@jiangnan.edu.cn %K chronic obstructive pulmonary disease %K randomized controlled trial %K self-efficacy %K telemedicine %K the eHealth enhanced chronic care model %K WeChat %D 2020 %7 21.4.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: The application of telemedicine in home pulmonary rehabilitation interventions for the management of patients with chronic obstructive pulmonary disease (COPD) has achieved promising results. Objective: This study aimed to develop a WeChat official account (Pulmonary Internet Explorer Rehabilitation [PeR]) based on social media. It further evaluated the effect of PeR on the quality of life, symptoms, and exercise self-efficacy of patients with COPD. Methods: The functional modules of PeR were developed by a multidisciplinary team according to the electronic health–enhanced chronic care model (eCCM) components. A total of 106 patients were randomly selected (53 in the PeR group and 53 in the outpatient face-to-face group [FtF]). Pulmonary rehabilitation intervention was conducted for 3 months, and the outcome was observed for 3 months. The primary outcome was patient quality of life measured with the COPD assessment test (CAT). The secondary outcomes were evaluated using the modified Medical Research Council scale (mMRC), exercise self-regulatory efficacy scale (Ex-SRES), and St George’s Respiratory Questionnaire (SGRQ). Results: The intention-to-treat analysis was used in the study. A total of 94 participants completed the 6-month pulmonary rehabilitation program. No statistically significant differences were observed in CAT (F1,3=7.78, P=.001), Ex-SRES (F1,3=21.91, P<.001), and mMRC scores (F1,3=29.64, P<.001) between the two groups with the variation in time tendency. The Ex-SRES score had a significant effect on the CAT score (P=.03). The partial regression coefficient of Ex-SRES to CAT was 0.81, and Exp (B) was 2.24. Conclusions: The telemedicine technology was effective using the eCCM combined with a behavioral intervention strategy centering on self-efficacy. Pulmonary rehabilitation at home through PeR and FtF could improve the sense of self-efficacy and quality of life and alleviate symptoms in patients with COPD. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900022770; https://tinyurl.com/tmmvpq3 %M 32314971 %R 10.2196/17089 %U http://www.jmir.org/2020/4/e17089/ %U https://doi.org/10.2196/17089 %U http://www.ncbi.nlm.nih.gov/pubmed/32314971 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 4 %P e14595 %T Sustainability of mHealth Effects on Cardiometabolic Risk Factors: Five-Year Results of a Randomized Clinical Trial %A Bernabe-Ortiz,Antonio %A Pauschardt,Julia %A Diez-Canseco,Francisco %A Miranda,J Jaime %+ CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Avenida Armendáriz 445, Miraflores, Lima, 15074, Peru, 51 12416978, antonio.bernabe@upch.pe %K mHealth %K low- and middle-income countries %K blood pressure %K body weight %D 2020 %7 21.4.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: The long-term effects of mobile health (mHealth) interventions have not been documented, especially in resource-constrained settings. Objective: This study aimed to assess the effects of a 1-year mHealth intervention on blood pressure levels and body weight in low-resource urban settings in Peru, 4 years after the completion of the original study. Methods: Four years after the original Grupo de Investigación en Salud Móvil en America Latina (GISMAL) study, we attempted to contact the 212 individuals originally enrolled in the study in Peru. The primary outcomes were systolic and diastolic blood pressure levels and hypertension incidence. Secondary outcome measures were body weight, BMI, and self-reported target behaviors. The study personnel collecting the data were masked to the group assignment. Linear mixed models were used to evaluate the effects of the intervention on primary and secondary outcomes in an intention-to-treat analysis. Results: Data from 164 (77.4%) of the 212 originally enrolled participants were available and analyzed (80 in the intervention group and 84 in the control group). The intervention did not result in changes in systolic (–2.54 mm Hg, 95% CI –8.23 to 3.15) or diastolic (3.41 mm Hg, 95% CI –0.75 to 7.57) blood pressure compared with the control group. The intervention reduced the risk of developing hypertension, but the result was not significant (risk ratio (RR) 0.76, 95% CI 0.45-1.28). However, those who received the intervention had lower body weight (–5.42 kg, 95% CI –10.4 to –0.48) and BMI (–2.56 kg/m2, 95% CI –4.46 to –0.66). In addition, compared to the control participants, those who received ≥50% of the scheduled calls during the intervention had greater reductions in body weight (–6.23 kg, 95% CI –11.47 to –0.99) and BMI (–2.81 kg/m2, 95% CI –4.77 to –0.85). Conclusions: An mHealth intervention comprising motivational interview calls and SMS text messaging appears to have effects on health 4 years after intervention completion. Although there were no effects on blood pressure levels, important reductions in body weight and BMI were seen 5 years after randomization. Thus, mHealth appears to be a promising preventive strategy for noncommunicable diseases in resource-constrained settings. Trial Registration: Clinicaltrials.gov NCT01295216; https://clinicaltrials.gov/ct2/show/NCT01295216 %M 32314970 %R 10.2196/14595 %U http://www.jmir.org/2020/4/e14595/ %U https://doi.org/10.2196/14595 %U http://www.ncbi.nlm.nih.gov/pubmed/32314970 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 6 %N 2 %P e17733 %T Effectiveness of a Web-Based Intervention to Support Medication Adherence Among People Living With HIV: Web-Based Randomized Controlled Trial %A Côté,José %A Rouleau,Geneviève %A Ramirez-Garcia,Maria Pilar %A Auger,Patricia %A Thomas,Réjean %A Leblanc,Judith %+ Research Centre of the Centre Hospitalier de l’Université de Montréal, 850 Rue Saint-Denis, Montreal, QC, H2X 0A9, Canada, 1 514 890 8000, jose.cote@umontreal.ca %K medication adherence %K people living with HIV %K antiretroviral therapy %K self-management %K nursing %K web-based intervention %K web-based randomized controlled trial %D 2020 %7 20.4.2020 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: Taking antiretroviral therapy (ART) is part of the daily life of people living with HIV. Different electronic health (eHealth) initiatives adjunctive to usual care have been proposed to support optimal medication adherence. A web-based intervention called HIV Treatment, Virtual Nursing Assistance, and Education or VIH-TAVIE (from its French version Virus de l’immunodéficience humaine-Traitement assistance virtuelle infirmière et enseignement) was developed to empower people living with HIV to manage their ART and symptoms optimally. Objective: We aimed to evaluate the effectiveness of VIH-TAVIE in a web-based randomized controlled trial (RCT). Methods: This RCT was entirely web-based, including recruitment, consent granting, questionnaire completion, and intervention exposure (consultation with VIH-TAVIE [experimental group] or websites [control group]). To be eligible for the study, people living with HIV had to be 18 years or older, be on ART for at least 6 months, have internet access, and have internet literacy. Participants were randomly assigned to either the experimental group (n=45) or control group (n=43). The primary outcome was ART adherence. The secondary outcomes included self-efficacy regarding medication intake, symptom-related discomfort, skills and strategies, and social support. All outcomes were measured with a self-administered web-based questionnaire at the following three time points: baseline and 3 and 6 months later. A generalized linear mixed model was built to assess the evolution of ART adherence over time in both groups. Results: The sample included 88 participants, and of these, 73 (83%) were men. The median age of the participants was 42 years. Participants had been diagnosed with HIV a median of 7 years earlier (IQR 3-17) and had been on ART for a median of 5 years (IQR 2-12). The proportion of treatment-adherent participants at baseline was high in both groups (34/41, 83% in the experimental group and 30/39, 77% in the control group). Participants also reported high treatment adherence, high self-efficacy, and high skills; perceived good social support; and experienced low discomfort from symptoms. Analyses revealed no intergroup difference regarding ART adherence (OR 1.9, 95% CI 0.6-6.4). Conclusions: This study highlights the challenges and lessons learned from conducting an entirely web-based RCT among people living with HIV. The challenges were related to the engagement of people living with HIV on the following three levels: starting the web-based study (recruitment), completing the web-based intervention (engagement), and continuing the study (retention). The results contribute to the existing body of knowledge regarding how to conduct web-based evaluation studies of eHealth interventions aimed at developing and strengthening personal skills and abilities. Trial Registration: ClinicalTrials.gov NCT01510340; https://clinicaltrials.gov/ct2/show/NCT01510340 %M 32310145 %R 10.2196/17733 %U http://publichealth.jmir.org/2020/2/e17733/ %U https://doi.org/10.2196/17733 %U http://www.ncbi.nlm.nih.gov/pubmed/32310145 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 4 %P e15474 %T Usage Metrics of Web-Based Interventions Evaluated in Randomized Controlled Trials: Systematic Review %A Koneska,Elena %A Appelbe,Duncan %A Williamson,Paula R %A Dodd,Susanna %+ Department of Biostatistics, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool, L69 3GL, United Kingdom, 44 1517949752, s.r.dodd@liverpool.ac.uk %K internet %K web-based interventions %K randomized controlled trial %K web usage data %K systematic review %D 2020 %7 16.4.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: The evaluation of web-based interventions (defined as an intervention that can be downloaded or accessed on the internet through a web browser) in randomized controlled trials (RCTs) has increased over the past two decades. Little is known about how participants’ use of the intervention is measured, reported, and analyzed in these studies. Objective: This study aimed to review the evaluation of web-based interventions in RCTs, assessing study characteristics and the methods used to record, and adjust for, intervention usage. Methods: A systematic review of the literature was undertaken to identify all published reports of RCTs that involved a web-based intervention. A random sample of 100 published trials was selected for detailed data extraction. Information on trial characteristics was extracted, including whether web usage data were recorded, and if so, the methods used to gather these data and whether these data were used to inform efficacy analyses. Results: A PubMed search identified 812 trials of web-based interventions published up to the end of 2017 and demonstrated a growing trend over time. Of the 100 studies reviewed, 90 studies collected web usage data, but more than half (49/90, 54%) of these studies did not state the method used for recording web usage. Only four studies attempted to check on the reliability of their web usage data collection methods. A total of 39% (35/90) studies reported patterns or levels of web intervention use, of which 21% (19/90) studies adjusted for intervention use in their outcome analysis, but only two of these used appropriate statistical methods. Conclusions: Trialists frequently report a measure of web-based intervention usage but do not always report the collection method or provide enough detail on their analysis of web usage. Appropriate statistical methods to account for intervention use are rarely used and are not well reported even in the very few trials in which they are used. The number of trialists who attempt to check on the reliability of their web usage collection methods is extremely low. %M 32297870 %R 10.2196/15474 %U http://www.jmir.org/2020/4/e15474/ %U https://doi.org/10.2196/15474 %U http://www.ncbi.nlm.nih.gov/pubmed/32297870 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 4 %P e15960 %T Automated Mobile Delivery of Financial Incentives for Smoking Cessation Among Socioeconomically Disadvantaged Adults: Feasibility Study %A Kendzor,Darla E %A Businelle,Michael S %A Waring,Joseph J C %A Mathews,Ashley J %A Geller,Daryl W %A Barton,Jocelyn M %A Alexander,Adam C %A Hébert,Emily T %A Ra,Chaelin K %A Vidrine,Damon J %+ Oklahoma Tobacco Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, 655 Research Parkway, Suite 400, Oklahoma City, OK, 73104, United States, 1 4052718001 ext 50478, Darla-Kendzor@ouhsc.edu %K socioeconomic status %K smoking cessation %K incentives %K mobile health %K mobile phone %D 2020 %7 15.4.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Socioeconomic disadvantage is associated with a reduced likelihood of smoking cessation. Smartphone ownership is increasing rapidly, including among low-income adults, and smartphone interventions for smoking cessation may increase access to smoking cessation treatment among socioeconomically disadvantaged adults. Objective: This study aimed to evaluate the feasibility of an automated smartphone-based approach to delivering financial incentives for smoking cessation. Methods: Socioeconomically disadvantaged adults initiating tobacco cessation treatment were followed from 1 week before a scheduled quit attempt through 26 weeks after the quit date. Participants received telephone counseling and nicotine replacement therapy. Smoking cessation was verified 5 times per week via smartphone prompts to self-report smoking status and submit a breath sample via a portable carbon monoxide (CO) monitor that was connected with participants’ smartphones. Identity was verified during smoking status assessments using smartphone-based facial recognition software. When smoking abstinence and identity were verified, an automated credit card payment was triggered. Participants were incentivized for abstinence on the quit date and up to five days per week during the first 4 weeks after the scheduled quit date, with additional incentives offered during postquit weeks 8 and 12. In total, participants had the opportunity to earn up to US $250 in abstinence-contingent incentives over the first 12 weeks of the quit attempt. Results: Participants (N=16) were predominantly female (12/16, 75%) and non-Hispanic white (11/16, 69%), black (4/16, 25%), or Hispanic of any race (1/16, 6%). Most participants (9/16, 56%) reported an annual household income of 0.30 was observed for main effects on any outcome, results suggest that for some outcomes, the combined intervention was stronger than individual factors alone. Conclusions: This factorial experiment demonstrates the effectiveness of text messaging as a strategy to increase engagement with an internet smoking cessation intervention, resulting in greater overall intervention dose and greater exposure to the core components of tobacco dependence treatment that can promote abstinence. Trial Registration: ClinicalTrials.gov NCT02585206; https://clinicaltrials.gov/ct2/show/NCT02585206. International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2015-010687 %M 32238338 %R 10.2196/17734 %U https://www.jmir.org/2020/4/e17734 %U https://doi.org/10.2196/17734 %U http://www.ncbi.nlm.nih.gov/pubmed/32238338 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 4 %P e15841 %T Efficacy of a Theory-Based Cognitive Behavioral Technique App-Based Intervention for Patients With Insomnia: Randomized Controlled Trial %A Rajabi Majd,Nilofar %A Broström,Anders %A Ulander,Martin %A Lin,Chung-Ying %A Griffiths,Mark D %A Imani,Vida %A Ahorsu,Daniel Kwasi %A Ohayon,Maurice M %A Pakpour,Amir H %+ Department of Rehabilitation Sciences, Hong Kong Polytechnic University, ST534 Department of Rehabilitation Sciences, Hung Hom, , China (Hong Kong), 852 27666755, cylin36933@gmail.com %K app-based intervention %K cognitive behavioral therapy, insomnia %K sleep hygiene %K theory of planned behavior %D 2020 %7 1.4.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Sleep hygiene is important for maintaining good sleep and reducing insomnia. Objective: This study examined the long-term efficacy of a theory-based app (including cognitive behavioral therapy [CBT], theory of planned behavior [TPB], health action process approach [HAPA], and control theory [CT]) on sleep hygiene among insomnia patients. Methods: The study was a 2-arm single-blind parallel-group randomized controlled trial (RCT). Insomnia patients were randomly assigned to a treatment group that used an app for 6 weeks (ie, CBT for insomnia [CBT-I], n=156) or a control group that received only patient education (PE, n=156) through the app. Outcomes were assessed at baseline and 1 month, 3 months, and 6 months postintervention. Primary outcomes were sleep hygiene, insomnia, and sleep quality. Secondary outcomes included attitudes toward sleep hygiene behavior, perceived behavioral control, behavioral intention, action and coping planning, self-monitoring, behavioral automaticity, and anxiety and depression. Linear mixed models were used to evaluate the magnitude of changes in outcomes between the two groups and across time. Results: Sleep hygiene was improved in the CBT-I group compared with the PE group (P=.02 at 1 month, P=.04 at 3 months, and P=.02 at 6 months) as were sleep quality and severity of insomnia. Mediation analyses suggested that perceived behavioral control on sleep hygiene as specified by TPB along with self-regulatory processes from HAPA and CT mediated the effect of the intervention on outcomes. Conclusions: Health care providers might consider using a CBT-I app to improve sleep among insomnia patients. Trial Registration: ClinicalTrials.gov NCT03605732; https://clinicaltrials.gov/ct2/show/NCT03605732 %M 32234700 %R 10.2196/15841 %U http://www.jmir.org/2020/4/e15841/ %U https://doi.org/10.2196/15841 %U http://www.ncbi.nlm.nih.gov/pubmed/32234700 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 3 %P e15033 %T Assessing Real-Time Moderation for Developing Adaptive Mobile Health Interventions for Medical Interns: Micro-Randomized Trial %A NeCamp,Timothy %A Sen,Srijan %A Frank,Elena %A Walton,Maureen A %A Ionides,Edward L %A Fang,Yu %A Tewari,Ambuj %A Wu,Zhenke %+ Department of Statistics, University of Michigan, 1085 South University Ave, Ann Arbor, MI, 48109, United States, 1 7346474820, tnecamp@umich.edu %K mobile health %K digital health %K smartphone %K mobile phone %K wearable devices %K ecological momentary assessment %K depression %K mood %K physical activity %K sleep %K moderator variables %D 2020 %7 31.3.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Individuals in stressful work environments often experience mental health issues, such as depression. Reducing depression rates is difficult because of persistently stressful work environments and inadequate time or resources to access traditional mental health care services. Mobile health (mHealth) interventions provide an opportunity to deliver real-time interventions in the real world. In addition, the delivery times of interventions can be based on real-time data collected with a mobile device. To date, data and analyses informing the timing of delivery of mHealth interventions are generally lacking. Objective: This study aimed to investigate when to provide mHealth interventions to individuals in stressful work environments to improve their behavior and mental health. The mHealth interventions targeted 3 categories of behavior: mood, activity, and sleep. The interventions aimed to improve 3 different outcomes: weekly mood (assessed through a daily survey), weekly step count, and weekly sleep time. We explored when these interventions were most effective, based on previous mood, step, and sleep scores. Methods: We conducted a 6-month micro-randomized trial on 1565 medical interns. Medical internship, during the first year of physician residency training, is highly stressful, resulting in depression rates several folds higher than those of the general population. Every week, interns were randomly assigned to receive push notifications related to a particular category (mood, activity, sleep, or no notifications). Every day, we collected interns’ daily mood valence, sleep, and step data. We assessed the causal effect moderation by the previous week’s mood, steps, and sleep. Specifically, we examined changes in the effect of notifications containing mood, activity, and sleep messages based on the previous week’s mood, step, and sleep scores. Moderation was assessed with a weighted and centered least-squares estimator. Results: We found that the previous week’s mood negatively moderated the effect of notifications on the current week’s mood with an estimated moderation of −0.052 (P=.001). That is, notifications had a better impact on mood when the studied interns had a low mood in the previous week. Similarly, we found that the previous week’s step count negatively moderated the effect of activity notifications on the current week’s step count, with an estimated moderation of −0.039 (P=.01) and that the previous week’s sleep negatively moderated the effect of sleep notifications on the current week’s sleep with an estimated moderation of −0.075 (P<.001). For all three of these moderators, we estimated that the treatment effect was positive (beneficial) when the moderator was low, and negative (harmful) when the moderator was high. Conclusions: These findings suggest that an individual’s current state meaningfully influences their receptivity to mHealth interventions for mental health. Timing interventions to match an individual’s state may be critical to maximizing the efficacy of interventions. Trial Registration: ClinicalTrials.gov NCT03972293; http://clinicaltrials.gov/ct2/show/NCT03972293 %M 32229469 %R 10.2196/15033 %U http://www.jmir.org/2020/3/e15033/ %U https://doi.org/10.2196/15033 %U http://www.ncbi.nlm.nih.gov/pubmed/32229469 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 3 %P e18047 %T Affect-Focused Psychodynamic Internet-Based Therapy for Adolescent Depression: Randomized Controlled Trial %A Lindqvist,Karin %A Mechler,Jakob %A Carlbring,Per %A Lilliengren,Peter %A Falkenström,Fredrik %A Andersson,Gerhard %A Johansson,Robert %A Edbrooke-Childs,Julian %A Dahl,Hanne-Sofie J %A Lindert Bergsten,Katja %A Midgley,Nick %A Sandell,Rolf %A Thorén,Agneta %A Topooco,Naira %A Ulberg,Randi %A Philips,Björn %+ Department of Psychology, Stockholm University, SE-106 91, Stockholm, Sweden, 46 (0)8 16 20 10, bjorn.philips@psychology.su.se %K depressive disorder %K adolescents %K psychodynamic %K internet-based treatment %K treatment outcome %K mobile phone %D 2020 %7 30.3.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Adolescent depression is one of the largest health issues in the world and there is a pressing need for effective and accessible treatments. Objective: This trial examines whether affect-focused internet-based psychodynamic therapy (IPDT) with therapist support is more effective than an internet-based supportive control condition on reducing depression in adolescents. Methods: The trial included 76 adolescents (61/76, 80% female; mean age 16.6 years), self-referred via an open access website and fulfilling criteria for major depressive disorder. Adolescents were randomized to 8 weeks of IPDT (38/76, 50%) or supportive control (38/76, 50%). The primary outcome was self-reported depressive symptoms, measured with the Quick Inventory of Depressive Symptomatology for Adolescents (QIDS-A17-SR). Secondary outcomes were anxiety severity, emotion regulation, self-compassion, and an additional depression measure. Assessments were made at baseline, postassessment, and at 6 months follow-up, in addition to weekly assessments of the primary outcome measure as well as emotion regulation during treatment. Results: IPDT was significantly more effective than the control condition in reducing depression (d=0.82, P=.01), the result of which was corroborated by the second depression measure (d=0.80, P<.001). IPDT was also significantly more effective in reducing anxiety (d=0.78, P<.001) and increasing emotion regulation (d=0.97, P<.001) and self-compassion (d=0.65, P=.003). Significantly more patients in the IPDT group compared to the control group met criteria for response (56% vs 21%, respectively) and remission (35% vs 8%, respectively). Results on depression and anxiety symptoms were stable at 6 months follow-up. On average, participants completed 5.8 (SD 2.4) of the 8 modules. Conclusions: IPDT may be an effective intervention to reduce adolescent depression. Further research is needed, including comparisons with other treatments. Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN) 16206254; http://www.isrctn.com/ISRCTN16206254 %M 32224489 %R 10.2196/18047 %U http://www.jmir.org/2020/3/e18047/ %U https://doi.org/10.2196/18047 %U http://www.ncbi.nlm.nih.gov/pubmed/32224489 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 3 %P e16547 %T Experiences of Internet-Based Stepped Care in Individuals With Cancer and Concurrent Symptoms of Anxiety and Depression: Qualitative Exploration Conducted Alongside the U-CARE AdultCan Randomized Controlled Trial %A Hauffman,Anna %A Alfonsson,Sven %A Igelström,Helena %A Johansson,Birgitta %+ Department of Immunology, Genetics and Pathology, Section of Experimental and Clinical Oncology, Uppsala University, Akademiska University Hospital ing 100 D, Uppsala, SE-751 85, Sweden, 46 18 611 00 00, anna.hauffman@igp.uu.se %K internet-based stepped care %K internet-based interactive health communication application %K internet-based intervention %K telemedicine %K patient portals %K oncology nursing %K self care %K psychoeducation %D 2020 %7 30.3.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Individuals with newly diagnosed cancer may experience impaired health in several aspects and often have a large need for information and support. About 30% will experience symptoms of anxiety and depression, with varying needs of knowledge and support. Despite this, many of these patients lack appropriate support. Internet-based support programs may offer a supplement to standard care services, but must be carefully explored from a user perspective. Objective: The purpose of this study was to explore the participants’ perceptions of the relevance and benefits of an internet-based stepped care program (iCAN-DO) targeting individuals with cancer and concurrent symptoms of anxiety and depression. Methods: We performed a qualitative study with an inductive approach, in which we used semistructured questions to interview 15 individuals using iCAN-DO. We analyzed the interviews using content analysis. Results: The analysis found 17 subcategories regarding the stepped care intervention, resulting in 4 categories. Participants described the need for information as large and looked upon finding information almost as a survival strategy when receiving the cancer diagnosis. iCAN-DO was seen as a useful, reliable source of information and support. It was used as a complement to standard care and as a means to inform next of kin. Increased knowledge was a foundation for continued processing of participants’ own feelings. The optimal time to gain access to iCAN-DO would have been when being informed of the diagnosis. The most common denominator was feeling acknowledged and supported, but with a desire for further adaptation of the system to each individual’s own situation and needs. Conclusions: Users saw the internet-based stepped care program as safe and reliable and used it as a complement to standard care. Similar interventions may gain from more personalized contents, being integrated into standard care, or using symptom tracking to adjust the contents. Offering this type of program close to diagnosis may provide benefits to users. Trial Registration: ClincalTrials.gov NCT-01630681; https://clinicaltrials.gov/ct2/show/NCT01630681 %M 32224483 %R 10.2196/16547 %U http://www.jmir.org/2020/3/e16547/ %U https://doi.org/10.2196/16547 %U http://www.ncbi.nlm.nih.gov/pubmed/32224483 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 3 %P e16769 %T Improving Self-Care in Patients With Coexisting Type 2 Diabetes and Hypertension by Technological Surrogate Nursing: Randomized Controlled Trial %A Or,Calvin Kalun %A Liu,Kaifeng %A So,Mike K P %A Cheung,Bernard %A Yam,Loretta Y C %A Tiwari,Agnes %A Lau,Yuen Fun Emmy %A Lau,Tracy %A Hui,Pui Sze Grace %A Cheng,Hop Chun %A Tan,Joseph %A Cheung,Michael Tow %+ Department of Industrial and Manufacturing Systems Engineering, University of Hong Kong, Room 8-7, Haking Wong Building, Hong Kong, Hong Kong, 852 3917 2587, klor@hku.hk %K technological surrogate nursing %K eHealth %K complex chronic disease %K diabetes %K hypertension %K self-care %K patient safety %D 2020 %7 27.3.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Technological surrogate nursing (TSN) derives from the idea that nurse-caregiver substitutes can be created by technology to support chronic disease self-care. Objective: This paper begins by arguing that TSN is a useful and viable approach to chronic disease self-care. The analysis then focuses on the empirical research question of testing and demonstrating the effectiveness and safety of prototype TSN supplied to patients with the typical complex chronic disease of coexisting type 2 diabetes and hypertension. At the policy level, it is shown that the data allow for a calibration of TSN technology augmentation, which can be readily applied to health care management. Methods: A 24-week, parallel-group, randomized controlled trial (RCT) was designed and implemented among diabetic and hypertensive outpatients in two Hong Kong public hospitals. Participants were randomly assigned to an intervention group, supplied with a tablet-based TSN app prototype, or to a conventional self-managing control group. Primary indices—hemoglobin A1c, systolic blood pressure, and diastolic blood pressure—and secondary indices were measured at baseline and at 8, 12, 16, and 24 weeks after initiation, after which the data were applied to test TSN effectiveness and safety. Results: A total of 299 participating patients were randomized to the intervention group (n=151) or the control group (n=148). Statistically significant outcomes that directly indicated TSN effectiveness in terms of hemoglobin 1c were found in both groups but not with regard to systolic and diastolic blood pressure. These findings also offered indirect empirical support for TSN safety. Statistically significant comparative changes in these primary indices were not observed between the groups but were suggestive of an operational calibration of TSN technology augmentation. Statistically significant changes in secondary indices were obtained in one or both groups, but not between the groups. Conclusions: The RCT’s strong behavioral basis, as well as the importance of safety and effectiveness when complex chronic illness is proximately self-managed by layperson patients, prompted the formulation of the empirical joint hypothesis that TSN would improve patient self-care while satisfying the condition of patient self-safety. Statistical and decision analysis applied to the experimental outcomes offered support for this hypothesis. Policy relevance of the research is demonstrated by the derivation of a data-grounded operational calibration of TSN technology augmentation with ready application to health care management. Trial Registration: ClinicalTrials.gov NCT02799953; https://clinicaltrials.gov/ct2/show/NCT02799953 %M 32217498 %R 10.2196/16769 %U http://www.jmir.org/2020/3/e16769/ %U https://doi.org/10.2196/16769 %U http://www.ncbi.nlm.nih.gov/pubmed/32217498 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 3 %P e15312 %T Brief Web-Based Intervention for Depression: Randomized Controlled Trial on Behavioral Activation %A Jelinek,Lena %A Arlt,Sönke %A Moritz,Steffen %A Schröder,Johanna %A Westermann,Stefan %A Cludius,Barbara %+ Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, Hamburg, 20246, Germany, 49 407410 ext 58087, ljelinek@uke.de %K affective disorders %K depressive symptoms %K brief psychotherapy %K internet %K world wide web %D 2020 %7 26.3.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based interventions have been shown to be effective for the treatment of depression. However, interventions are often complex and include a variety of elements, making it difficult to identify the most effective component(s). Objective: The aim of this pilot study was to shed light on mechanisms in the online treatment of depression by comparing a single-module, fully automated intervention for depression (internet-based behavioral activation [iBA]) to a nonoverlapping active control intervention and a nonactive control group. Methods: We assessed 104 people with at least mild depressive symptoms (Patient Health Questionnaire-9, >4) via the internet at baseline (t0) and 2 weeks (t1) and 4 weeks (t2) later. After the t0 assessment, participants were randomly allocated to one of three groups: (1) iBA (n=37), (2) active control using a brief internet-based mindfulness intervention (iMBI, n=32), or (3) care as usual (CAU, n=35). The primary outcome was improvement in depressive symptoms, as measured using the Patient Health Questionnaire-9. Secondary parameters included changes in activity, dysfunctional attitudes, and quality of life Results: While groups did not differ regarding the change in depression from t0 to t1 (ηp2=.007, P=.746) or t0 to t2 (ηp2=.008, P=.735), iBA was associated with a larger decrease in dysfunctional attitudes from t0 to t2 in comparison to CAU (ηp2=.053, P=.04) and a larger increase in activity from t0 to t1 than the pooled control groups (ηp2=.060, P=.02). A change in depression from t0 to t2 was mediated by a change in activity from t0 to t1. At t1, 22% (6/27) of the participants in the iBA group and 12% (3/25) of the participants in the iMBI group indicated that they did not use the intervention. Conclusions: Although we did not find support for the short-term efficacy of the single-module iBA regarding depression, long-term effects are still conceivable, potentially initiated by changes in secondary outcomes. Future studies should use a longer intervention and follow-up interval. Trial Registration: DKRS (#DRKS00011562) %M 32213470 %R 10.2196/15312 %U http://www.jmir.org/2020/3/e15312/ %U https://doi.org/10.2196/15312 %U http://www.ncbi.nlm.nih.gov/pubmed/32213470 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 3 %P e15824 %T The Association of Therapeutic Alliance With Long-Term Outcome in a Guided Internet Intervention for Depression: Secondary Analysis From a Randomized Control Trial %A Gómez Penedo,Juan Martín %A Babl,Anna Margarete %A grosse Holtforth,Martin %A Hohagen,Fritz %A Krieger,Tobias %A Lutz,Wolfgang %A Meyer,Björn %A Moritz,Steffen %A Klein,Jan Philipp %A Berger,Thomas %+ Department of Clinical Psychology and Psychotherapy, University of Bern, Fabrikstrasse 8, Bern, 3012, Switzerland, 41 31 631 5424, jmgomezpenedo@gmail.com %K internet interventions %K guidance %K alliance %K Working Alliance Inventory for Guided Internet Intervention %K only interventions %K tasks and goals %K bond %D 2020 %7 24.3.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Therapeutic alliance has been well established as a robust predictor of face-to-face psychotherapy outcomes. Although initial evidence positioned alliance as a relevant predictor of internet intervention success, some conceptual and methodological concerns were raised regarding the methods and instruments used to measure the alliance in internet interventions and its association with outcomes. Objective: The aim of this study was to explore the alliance-outcome association in a guided internet intervention using a measure of alliance especially developed for and adapted to guided internet interventions, showing evidence of good psychometric properties. Methods: A sample of 223 adult participants with moderate depression received an internet intervention (ie, Deprexis) and email support. They completed the Working Alliance Inventory for Guided Internet Intervention (WAI-I) and a measure of treatment satisfaction at treatment termination and measures of depression severity and well-being at termination and 3- and 9-month follow-ups. For data analysis, we used two-level hierarchical linear modeling that included two subscales of the WAI-I (ie, tasks and goals agreement with the program and bond with the supporting therapist) as predictors of the estimated values of the outcome variables at the end of follow-up and their rate of change during the follow-up period. The same models were also used controlling for the effect of patient satisfaction with treatment. Results: We found significant effects of the tasks and goals subscale of the WAI-I on the estimated values of residual depressive symptoms (γ02=−1.74, standard error [SE]=0.40, 95% CI −2.52 to −0.96, t206=−4.37, P<.001) and patient well-being (γ02=3.10, SE=1.14, 95% CI 0.87-5.33, t198=2.72, P=.007) at the end of follow-up. A greater score in this subscale was related to lower levels of residual depressive symptoms and a higher level of well-being. However, there were no significant effects of the tasks and goals subscale on the rate of change in these variables during follow-up (depressive symptoms, P=.48; patient well-being, P=.26). The effects of the bond subscale were also nonsignificant when predicting the estimated values of depressive symptoms and well-being at the end of follow-up and the rate of change during that period (depressive symptoms, P=.08; patient well-being, P=.68). Conclusions: The results of this study point out the importance of attuning internet interventions to patients’ expectations and preferences in order to enhance their agreement with the tasks and goals of the treatment. Thus, the results support the notion that responsiveness to a patient’s individual needs is crucial also in internet interventions. Nevertheless, these findings need to be replicated to establish if they can be generalized to different diagnostic groups, internet interventions, and supporting formats. %M 32207689 %R 10.2196/15824 %U https://www.jmir.org/2020/3/e15824 %U https://doi.org/10.2196/15824 %U http://www.ncbi.nlm.nih.gov/pubmed/32207689 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 3 %P e16660 %T Measuring Alliance Toward Embodied Virtual Therapists in the Era of Automated Treatments With the Virtual Therapist Alliance Scale (VTAS): Development and Psychometric Evaluation %A Miloff,Alexander %A Carlbring,Per %A Hamilton,William %A Andersson,Gerhard %A Reuterskiöld,Lena %A Lindner,Philip %+ Department of Psychology, Stockholm University, Frescati Hagväg 8, C402, Stockholm, SE-106 91, Sweden, 46 08 163680, alexander.miloff@psychology.su.se %K alliance %K virtual reality %K exposure therapy %K automated treatment %K psychometric %K embodiment %K virtual therapist %K virtual coach %K avatar %K usability %K presence %K empathy %D 2020 %7 24.3.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Automated virtual reality exposure therapies (VRETs) are self-help treatments conducted by oneself and supported by a virtual therapist embodied visually and/or with audio feedback. This simulates many of the nonspecific relational elements and common factors present in face-to-face therapy and may be a means of improving adherence to and efficacy of self-guided treatments. However, little is known about alliance toward the virtual therapist, despite alliance being an important predictor of treatment outcome. Objective: In this study, we aimed to evaluate the first alliance instrument developed for use with embodied virtual therapists in an automated treatment format—the Virtual Therapist Alliance Scale (VTAS)—by (1) assessing its psychometric properties, (2) verifying the dimensionality of the scale, and (3) determining the predictive ability of the scale with treatment outcome. Methods: A psychometric evaluation and exploratory factor analysis of the VTAS was conducted using data from two samples of spider-fearful patients treated with VRET and the help of an embodied, voice-based virtual therapist (n=70). Multiple regression models and bivariate correlations were used to assess the VTAS relationship with treatment outcome, according to self-reported fear and convergence with presence and user-friendliness process measures. Results: The VTAS showed a sound two-factor solution composed of a primary factor covering task, goal, and copresence; adequate internal consistency; and good convergent validity, including moderate correlation (r=.310, P=.01) with outcomes over follow-up. Conclusions: These preliminary results suggest that alliance toward a virtual therapist is a significant predictor of treatment outcome, favors the importance of a task-goal over bond-factor, and should be explored in studies with larger sample sizes and in additional forms of embodiment. %M 32207690 %R 10.2196/16660 %U https://www.jmir.org/2020/3/e16660 %U https://doi.org/10.2196/16660 %U http://www.ncbi.nlm.nih.gov/pubmed/32207690 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 3 %P e14860 %T Three Decades of Internet- and Computer-Based Interventions for the Treatment of Depression: Protocol for a Systematic Review and Meta-Analysis %A Moshe,Isaac %A Terhorst,Yannik %A Cuijpers,Pim %A Cristea,Ioana %A Pulkki-Råback,Laura %A Sander,Lasse %+ Department of Rehabilitation Psychology and Psychotherapy, University of Freiburg, Engelbergerstrasse 41, Freiburg, 79085, Germany, 49 761 203 3049, lasse.sander@psychologie.uni-freiburg.de %K depression %K internet-based interventions %K meta-analysis %K review %D 2020 %7 24.3.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Depression is one of the leading causes of disability worldwide. Internet- and computer-based interventions (IBIs) have been shown to provide effective, scalable forms of treatment. More than 100 controlled trials and a growing number of meta-analyses published over the past 30 years have demonstrated the efficacy of IBIs in reducing symptoms in the short and long term. Despite the large body of research, no comprehensive review or meta-analysis has been conducted to date that evaluates how the effectiveness of IBIs has evolved over time. Objective: This systematic review and meta-analysis aims to evaluate whether there has been a change in the effectiveness of IBIs on the treatment of depression over the past 30 years and to identify potential variables moderating the effect size. Methods: A sensitive search strategy will be executed across the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and PsycINFO. Data extraction and evaluation will be conducted by two independent researchers. Risk of bias will be assessed. A multilevel meta-regression model will be used to analyze the data and estimate effect size. Results: The search was completed in mid-2019. We expect the results to be submitted for publication in early 2020. Conclusions: The year 2020 will mark 30 years since the first paper was published on the use of IBIs for the treatment of depression. Despite the large and rapidly growing body of research in the field, evaluations of effectiveness to date are missing the temporal dimension. This review will address that gap and provide valuable analysis of how the effectiveness of interventions has evolved over the past three decades; which participant-, intervention-, and study-related variables moderate changes in effectiveness; and where research in the field may benefit from increased focus. Trial Registration: PROSPERO CRD42019136554; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=136554 International Registered Report Identifier (IRRID): PRR1-10.2196/14860 %M 32207695 %R 10.2196/14860 %U http://www.researchprotocols.org/2020/3/e14860/ %U https://doi.org/10.2196/14860 %U http://www.ncbi.nlm.nih.gov/pubmed/32207695 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 3 %P e15172 %T The Effectiveness of a Guided Internet-Based Tool for the Treatment of Depression and Anxiety in Pregnancy (MamaKits Online): Randomized Controlled Trial %A Heller,Hanna M %A Hoogendoorn,Adriaan W %A Honig,Adriaan %A Broekman,Birit F P %A van Straten,Annemieke %+ Department of Psychiatry, Amsterdam Universitair Medische Centra, Vrije Universiteit Amsterdam, de Boelelaan 1117, Amsterdam, 1081 HV, Netherlands, 31 204440196, hm.heller@amsterdamumc.nl %K pregnancy %K depression %K anxiety %K internet %K pregnancy outcome %K treatment %D 2020 %7 23.3.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Pregnant women with symptoms of depression or anxiety often do not receive adequate treatment. In view of the high incidence of these symptoms in pregnancy and their impact on pregnancy outcomes, getting treatment is of the utmost importance. A guided internet self-help intervention may help to provide more women with appropriate treatment. Objective: This study aimed to examine the effectiveness of a guided internet intervention (MamaKits online) for pregnant women with moderate to severe symptoms of anxiety or depression. Assessments took place before randomization (T0), post intervention (T1), at 36 weeks of pregnancy (T2), and 6 weeks postpartum (T3). We also explored effects on perinatal child outcomes 6 weeks postpartum. Methods: This randomized controlled trial included pregnant women (<30 weeks) with depressive symptoms above threshold (ie, Center for Epidemiological Studies Depression scale [CES-D] >16) or anxiety above threshold (ie, Hospital Anxiety and Depression Scale-Anxiety subscale [HADS-A] >8) or both of them. Participants were recruited via general media and flyers in prenatal care waiting rooms or via obstetricians and midwives. After initial assessment, women were randomized to (1) MamaKits online in addition to treatment as usual or (2) treatment as usual (control condition). MamaKits online is a 5-week guided internet intervention based on problem solving treatment. Guidance was was provided by trained students pursuing a Master's in Psychology. Outcomes were based on a Web-based self-report. Women in the control condition were allowed to receive the intervention after the last assessment (6 weeks postpartum). Results: Of the 159 included women, 79 were randomized to MamaKits online, 47% (79/37) of whom completed the intervention. Both groups showed a substantial decrease in affective symptoms on the CES-D, HADS-A, and Edinburgh Postnatal Depression Scale over time. In the intervention group, affective symptoms decreased more than that in the control group, but between-group effect sizes were small to medium (Cohen d at T3=0.45, 0.21, and 0.23 for the 3 questionnaires, respectively) and statistically not significant. Negative perinatal child outcomes did not differ between the 2 groups (χ21=0.1; P=.78). Completer analysis revealed no differences in outcome between the treatment completers and the control group. The trial was terminated early for reasons of futility based on the results of an interim analysis, which we performed because of inclusion problems. Conclusions: Our study did show a significant reduction in affective symptoms in both groups, but the differences in reduction of affective symptoms between the intervention and control groups were not significant. There were also no differences in perinatal child outcomes. Future research should examine for which women these interventions might be effective or if changes in the internet intervention might make the intervention more effective. Trial Registration: Netherlands Trial Register NL4162; https://tinyurl.com/sdckjek %M 32202505 %R 10.2196/15172 %U http://www.jmir.org/2020/3/e15172/ %U https://doi.org/10.2196/15172 %U http://www.ncbi.nlm.nih.gov/pubmed/32202505 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 3 %P e15578 %T The Feasibility and Effectiveness of Web-Based Advance Care Planning Programs: Scoping Review %A van der Smissen,Doris %A Overbeek,Anouk %A van Dulmen,Sandra %A van Gemert-Pijnen,Lisette %A van der Heide,Agnes %A Rietjens,Judith AC %A Korfage,Ida J %+ Department of Public Health, Erasmus MC, University Medical Center Rotterdam, P O Box 2040, Rotterdam, 3000 CA, Netherlands, 31 107038470, d.vandersmissen@erasmusmc.nl %K advance care planning %K Web-based intervention %K decision aids %K patient education %K eHealth %K health communication %K patient-centered care %K chronic disease %D 2020 %7 17.3.2020 %9 Review %J J Med Internet Res %G English %X Background: Advance care planning (ACP) is a process with the overall aim to enhance care in concordance with patients’ preferences. Key elements of ACP are to enable persons to define goals and preferences for future medical treatment and care, to discuss these with family and health care professionals, and to document and review these if appropriate. ACP is usually conducted through personal conversations between a health care professional, a patient, and—if appropriate—family members. Although Web-based ACP programs have the potential to support patients in ACP, their effectiveness is unknown. Objective: This study aimed to assess the feasibility and effectiveness of Web-based, interactive, and person-centered ACP programs. Methods: We systematically searched for quantitative and qualitative studies evaluating Web-based, interactive, and person-centered ACP programs in seven databases including EMBASE, Web of Science, Cochrane Central and Google Scholar. Data on the characteristics of the ACP programs’ content (using a predefined list of 10 key elements of ACP), feasibility, and effectiveness were extracted using a predesigned form. Results: Of 3434 titles and abstracts, 27 studies met the inclusion criteria, evaluating 11 Web-based ACP programs—10 were developed in the United States and one in Ireland. Studied populations ranged from healthy adults to patients with serious conditions. Programs typically contained the exploration of goals and values (8 programs), exploration of preferences for treatment and care (11 programs), guidance for communication about these preferences with health care professionals or relatives (10 programs), and the possibility to generate a document in which preferences can be recorded (8 programs). Reportedly, participants were satisfied with the ACP programs (11/11 studies), considering them as easy to use (8/8 studies) and not burdensome (7/8 studies). Designs of 13 studies allowed evaluating the effectiveness of five programs. They showed that ACP programs significantly increased ACP knowledge (8/8 studies), improved communication between patients and their relatives or health care professionals (6/6 studies), increased ACP documentation (6/6 studies), and improved concordance between care as preferred by the patients and the decisions of clinicians and health care representatives (2/3 studies). Conclusions: Web-based, interactive, and person-centered ACP programs were mainly developed and evaluated in the United States. They contained the key elements of ACP, such as discussing and documenting goals and preferences for future care. As participants considered programs as easy to use and not burdensome, they appeared to be feasible. Among the 13 studies that measured the effectiveness of programs, improvement in ACP knowledge, communication, and documentation was reported. The concordance between preferred and received care is yet understudied. Studies with high-quality study designs in different health care settings are warranted to further establish the feasibility and effectiveness of Web-based ACP programs. %M 32181750 %R 10.2196/15578 %U http://www.jmir.org/2020/3/e15578/ %U https://doi.org/10.2196/15578 %U http://www.ncbi.nlm.nih.gov/pubmed/32181750 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 3 %P e17167 %T Efficacy of a Web App for Cognitive Training (MeMo) Regarding Cognitive and Behavioral Performance in People With Neurocognitive Disorders: Randomized Controlled Trial %A Robert,Philippe %A Manera,Valeria %A Derreumaux,Alexandre %A Ferrandez Y Montesino,Marion %A Leone,Elsa %A Fabre,Roxane %A Bourgeois,Jeremy %+ Cognition Behaviour Technology Lab, Université Côte d'Azur, Institut Claude Pompidou, 10 Rue Moliere, Nice, 06100, France, 33 0492034770, Philippe.ROBERT@univ-cotedazur.fr %K neurocognitive disorders %K Alzheimer disease %K cognition %K motivation %K apathy %K intervention %D 2020 %7 11.3.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Cognitive and behavioral symptoms are the clinical hallmarks of neurocognitive disorders. Cognitive training may be offered to reduce the risks of cognitive decline and dementia and to reduce behavioral symptoms, such as apathy. Information and communication technology approaches, including serious games, can be useful in improving the playful aspect of computerized cognitive training and providing motivating solutions in elderly patients. Objective: The objective of this study was to assess the effectiveness of employing the MeMo (Memory Motivation) Web app with regard to cognitive and behavioral symptoms in patients with neurocognitive disorders. Methods: MeMo is a Web app that can be used on any Web browser (computer or tablet). The training activities proposed in MeMo are divided into the following two parts: memory and mental flexibility/attention. The study included 46 individuals (mean age 79.4 years) with a diagnosis of neurocognitive disorders at the Institut Claude Pompidou Memory Center in Nice. This randomized controlled study compared the evolution of cognition and behavior between patients not using MeMo (control group) and patients using MeMo (MeMo group) for 12 weeks (four sessions per week). Patients underwent memory and attention tests, as well as an apathy assessment at baseline, week 12 (end of the training period), and week 24 (12 weeks after the end of the training sessions). In addition, to assess the impact of high and low game uses, the MeMo group was divided into patients who used MeMo according to the instructions (about once every 2 days; active MeMo group) and those who used it less (nonactive MeMo group). Results: When comparing cognitive and behavioral scores among baseline, week 12, and week 24, mixed model analysis for each cognitive and behavioral score indicated no significant interaction between testing time and group. On comparing the active MeMo group (n=9) and nonactive MeMo group (n=13), there were significant differences in two attention tests (Trial Making Test A [P=.045] and correct Digit Symbol Substitution Test items [P=.045]) and in the Apathy Inventory (AI) (P=.02). Mixed analysis (time: baseline, week 12, and week 24 × number of active days) indicated only one significant interaction for the AI score (P=.01), with a significant increase in apathy in the nonactive MeMo group. Conclusions: This study indicates that the cognitive and behavioral efficacies of MeMo, a Web-based training app, can be observed only with regular use of the app. Improvements were observed in attention and motivation. Trial Registration: ClinicalTrials.gov NCT04142801; https://clinicaltrials.gov/ct2/show/NCT04142801 %M 32159519 %R 10.2196/17167 %U https://www.jmir.org/2020/3/e17167 %U https://doi.org/10.2196/17167 %U http://www.ncbi.nlm.nih.gov/pubmed/32159519 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 3 %P e16907 %T A Mobile Just-in-Time Adaptive Intervention for Smoking Cessation: Pilot Randomized Controlled Trial %A Hébert,Emily T %A Ra,Chaelin K %A Alexander,Adam C %A Helt,Angela %A Moisiuc,Rachel %A Kendzor,Darla E %A Vidrine,Damon J %A Funk-Lawler,Rachel K %A Businelle,Michael S %+ Oklahoma Tobacco Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, 655 Research Parkway, Suite 400, Oklahoma City, OK, 73104, United States, 1 4052718001 ext 50558, Emily-Hebert@ouhsc.edu %K smartphones %K mobile phones %K smoking cessation %K just-in-time adaptive intervention %K mHealth %D 2020 %7 9.3.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Smartphone apps for smoking cessation could offer easily accessible, highly tailored, intensive interventions at a fraction of the cost of traditional counseling. Although there are hundreds of publicly available smoking cessation apps, few have been empirically evaluated using a randomized controlled trial (RCT) design. The Smart-Treatment (Smart-T2) app is a just-in-time adaptive intervention that uses ecological momentary assessments (EMAs) to assess the risk for imminent smoking lapse and tailors treatment messages based on the risk of lapse and reported symptoms. Objective: This 3-armed pilot RCT aimed to determine the feasibility and preliminary efficacy of an automated smartphone-based smoking cessation intervention (Smart-T2) relative to standard in-person smoking cessation clinic care and the National Cancer Institute’s free smoking cessation app, QuitGuide. Methods: Adult smokers who attended a clinic-based tobacco cessation program were randomized into groups and followed for 13 weeks (1 week prequitting through 12 weeks postquitting). All study participants received nicotine patches and gum and were asked to complete EMAs five times a day on study-provided smartphones for 5 weeks. Participants in the Smart-T2 group received tailored treatment messages after the completion of each EMA. Both Smart-T2 and QuitGuide apps offer on-demand smoking cessation treatment. Results: Of 81 participants, 41 (50%) were women and 55 (68%) were white. On average, participants were aged 49.6 years and smoked 22.4 cigarettes per day at baseline. A total of 17% (14/81) of participants were biochemically confirmed 7-day point prevalence abstinent at 12 weeks postquitting (Smart-T2: 6/27, 22%, QuitGuide: 4/27, 15%, and usual care: 4/27, 15%), with no significant differences across groups (P>.05). Participants in the Smart-T2 group rated the app positively, with most participants agreeing that they can rely on the app to help them quit smoking, and endorsed the belief that the app would help them stay quit, and these responses were not significantly different from the ratings given by participants in the usual care group. Conclusions: Dynamic smartphone apps that tailor intervention content in real time may increase user engagement and exposure to treatment-related materials. The results of this pilot RCT suggest that smartphone-based smoking cessation treatments may be capable of providing similar outcomes to traditional, in-person counseling. Trial Registration: ClinicalTrials.gov NCT02930200; https://clinicaltrials.gov/show/NCT02930200 %M 32149716 %R 10.2196/16907 %U https://www.jmir.org/2020/3/e16907 %U https://doi.org/10.2196/16907 %U http://www.ncbi.nlm.nih.gov/pubmed/32149716 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 3 %P e14297 %T The Interactive Web-Based Program MSmonitor for Self-Management and Multidisciplinary Care in Persons With Multiple Sclerosis: Quasi-Experimental Study of Short-Term Effects on Patient Empowerment %A Jongen,Peter Joseph %A ter Veen,Gezien %A Lemmens,Wim %A Donders,Rogier %A van Noort,Esther %A Zeinstra,Esther %+ MS4 Research Institute, Ubbergseweg 34, Nijmegen, 6522 KJ, Netherlands, 31 243239146, ms4ri@kpnmail.nl %K multiple sclerosis %K empowerment %K self-management %K eHealth %K internet-based intervention %K internet-based communication %K personal autonomy %K social participation %K self-efficacy %D 2020 %7 9.3.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Empowerment helps persons with a chronic disease to self-manage their condition and increase their autonomy and participation. MSmonitor (Curavista bv) is an interactive Web-based program for self-management and multidisciplinary care in multiple sclerosis (MS). It includes, among others, short questionnaires on fatigue (Modified Fatigue Impact Scale-5 [MFIS-5]) and health-related quality of life (HRQoL, Leeds Multiple Sclerosis Quality of Life [LMSQoL]); long questionnaires on disabilities, perception of disabilities (Multiple Sclerosis Impact Profile), and HRQoL (Multiple Sclerosis Quality of Life-54); a Medication and Adherence Inventory and an Activity Diary. The combination MFIS-5, LMSQoL, and Medication and Adherence Inventory constitutes the Quick Scan. Objective: This study aimed to investigate the short-term effects of MSmonitor on empowerment in patients with MS. Methods: We conducted a quasi-experimental study in a general hospital. Of the 180 patients with MS, 125 were eligible, 30 used MSmonitor, and 21 participated in the study (mean age 45.4 years, SD 10.2 years). A total of 24 eligible patients who did not use MSmonitor constituted the control group (mean age 49.3 years, SD 11.4 years). At baseline and at 4 months, we assessed self-efficacy (Multiple Sclerosis Self-Efficacy Scale [MSSES]), participation and autonomy (Impact on Participation and Autonomy [IPA] questionnaire), and self-management (Partners In Health [PIH] questionnaire). Differences between time points and groups were tested with paired t tests and χ² tests. Results: In the MSmonitor group, follow-up values remained unchanged for MSSES control (P=.19), MSSES function (P=.62), IPA limitations (P=.26), IPA problems (P=.40), PIH recognition and management of symptoms (P=.52), PIH adherence to treatment (P=.80), and PIH coping (P=.73), whereas the PIH knowledge score had improved (mean 27.8, SD 1.7 vs mean 28.7, SD 2.0; P=.02). The overall utilization rate of the program components was 83% and that of the Quick Scan was 95%. In the control group, all outcomes had remained unchanged. Conclusions: The results suggest that for first-time users of the MSmonitor program and their health care providers, it may not be justified to expect a short-term improvement in empowerment in terms of self-efficacy, self-management, autonomy, or participation. Furthermore, a lack of effect on empowerment is not because of nonusage of the program components. %M 32149713 %R 10.2196/14297 %U https://www.jmir.org/2020/3/e14297 %U https://doi.org/10.2196/14297 %U http://www.ncbi.nlm.nih.gov/pubmed/32149713 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 3 %P e15800 %T A Values-Tailored Web-Based Intervention for New Mothers to Increase Infant Vaccine Uptake: Development and Qualitative Study %A Dempsey,Amanda %A Kwan,Bethany M %A Wagner,Nicole M %A Pyrzanowski,Jennifer %A Brewer,Sarah E %A Sevick,Carter %A Narwaney,Komal %A Resnicow,Kenneth %A Glanz,Jason %+ University of Colorado, Denver, 13199 East Montview Blvd, Suite 300, Aurora, CO, 80045, United States, 1 3037246679, amanda.dempsey@ucdenver.edu %K immunization %K parents %D 2020 %7 5.3.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Vaccine hesitancy among parents leads to childhood undervaccination and outbreaks of vaccine-preventable disease. As the reasons for vaccine hesitancy are diverse, there is often not enough time during regular clinical visits for medical providers to adequately address all the concerns that parents have. Providing individually tailored vaccine information via the internet before a clinical visit may be a good mechanism for effectively allaying parents’ vaccination concerns while also being time efficient. Including tailoring based on values is a promising, but untested, approach to message creation. Objective: This study aimed to describe the process by which we developed a Web-based intervention that is being used in an ongoing randomized controlled trial aimed at improving the timeliness of infant vaccination by reducing parental vaccine hesitancy. Methods: Development of the intervention incorporated evidence-based health behavior theories. A series of interviews, surveys, and feedback sessions were used to iteratively develop the intervention in collaboration with vaccination experts and potential end users. Results: In all, 41 specific content areas were identified to be included in the intervention. User feedback elucidated preferences for specific design elements to be incorporated throughout the website. The tile-based architecture chosen for the website was perceived as easy to use. Creating messages that were two-sided was generally preferred over other message formats. Quantitative surveys identified associations between specific vaccine values and vaccination beliefs, suggesting that values tailoring should vary, depending on the specific belief being endorsed. Conclusions: Using health behavior theories, qualitative and quantitative data, and significant expert and end user input, we created a novel, Web-based intervention to improve infant vaccination timeliness. The intervention is based on tailoring messages according to each individual’s values and beliefs. This intervention is currently being tested in a controlled randomized clinical trial. %M 32134394 %R 10.2196/15800 %U https://www.jmir.org/2020/3/e15800 %U https://doi.org/10.2196/15800 %U http://www.ncbi.nlm.nih.gov/pubmed/32134394 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 3 %P e15509 %T Dyadic Psychosocial eHealth Interventions: Systematic Scoping Review %A Shaffer,Kelly M %A Tigershtrom,Ashley %A Badr,Hoda %A Benvengo,Stephanie %A Hernandez,Marisol %A Ritterband,Lee M %+ Center for Behavioral Health and Technology, University of Virginia School of Medicine, PO Box 801075, Charlottesville, VA, 22908, United States, 1 4349821022, kshaffer@virginia.edu %K behavioral medicine %K caregivers %K couples therapy %K dyads %K eHealth %K family therapy %K internet interventions %K psychosocial interventions %K review %D 2020 %7 4.3.2020 %9 Review %J J Med Internet Res %G English %X Background: Dyadic psychosocial interventions have been found beneficial both for people coping with mental or physical health conditions as well as their family members and friends who provide them with support. Delivering these interventions via electronic health (eHealth) may help increase their scalability. Objective: This scoping review aimed to provide the first comprehensive overview of dyadic eHealth interventions for individuals of all ages affected by mental or physical illness and their family members or friends who support them. The goal was to understand how dyadic eHealth interventions have been used and to highlight areas of research needed to advance dyadic eHealth intervention development and dissemination. Methods: A comprehensive electronic literature search of PubMed, EMBASE, Cochrane, Cumulative Index to Nursing and Allied Health Literature, and PsycINFO was conducted for articles published in the English language through March 2019. Eligible records described a psychosocial eHealth intervention that intervened with both care recipients and their support person. Results: A total of 7113 records were reviewed of which 101 met eligibility criteria. There were 52 unique dyadic eHealth interventions identified, which were tested across 73 different trials. Of the unique interventions, 33 were conducted among dyads of children and their supporting parent, 1 was conducted with an adolescent-young adult care recipient population, and the remaining 18 were conducted among adult dyads. Interventions targeting pediatric dyads most commonly addressed a mental health condition (n=10); interventions targeting adult dyads most commonly addressed cancer (n=9). More than three-fourths of interventions (n=40) required some human support from research staff or clinicians. Most studies (n=64) specified one or more primary outcomes for care recipients, whereas less than one-fourth (n=22) specified primary outcomes for support persons. Where specified, primary outcomes were most commonly self-reported psychosocial or health factors for both care recipients (n=43) and support persons (n=18). Results of the dyadic eHealth intervention tended to be positive for care recipients, but evidence of effects for support persons was limited because of few studies specifying primary outcomes for supporters. Trials of dyadic eHealth interventions were most commonly randomized controlled trials (RCTs; n=44), and RCTs most commonly compared the dyadic eHealth intervention to usual care alone (n=22). Conclusions: This first comprehensive review of dyadic eHealth interventions demonstrates that there is substantial, diverse, and growing literature supporting this interventional approach. However, several significant gaps were identified. Few studies were designed to evaluate the unique effects of dyadic interventions relative to individual interventions. There was also limited assessment and reporting of outcomes for support persons, and there were no interventions meeting our eligibility criteria specifically targeting the needs of older adult dyads. Findings highlight areas of research opportunities for developing dyadic eHealth interventions for novel populations and for increasing access to dyadic care. %M 32130143 %R 10.2196/15509 %U https://www.jmir.org/2020/3/e15509 %U https://doi.org/10.2196/15509 %U http://www.ncbi.nlm.nih.gov/pubmed/32130143 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 2 %P e13055 %T Dose-Response Effect of a Digital Health Intervention During Cardiac Rehabilitation: Subanalysis of Randomized Controlled Trial %A Widmer,R Jay %A Senecal,Conor %A Allison,Thomas G %A Lopez-Jimenez,Francisco %A Lerman,Lilach O %A Lerman,Amir %+ Department of Health Sciences Research, Mayo Clinic, 200 First Street SW, Rochester, MN, United States, 1 507 255 2446, lerman.amir@mayo.edu %K cardiovascular prevention %K secondary prevention %K online %K digital health interventions %D 2020 %7 26.2.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Previous data have validated the benefit of digital health interventions (DHIs) on weight loss in patients following acute coronary syndrome entering cardiac rehabilitation (CR). Objective: The primary purpose of this study was to test the hypothesis that increased DHI use, as measured by individual log-ins, is associated with improved weight loss. Secondary analyses evaluated the association between log-ins and activity within the platform and exercise, dietary, and medication adherence. Methods: We obtained DHI data including active days, total log-ins, tasks completed, educational modules reviewed, medication adherence, and nonmonetary incentive points earned in patients undergoing standard CR following acute coronary syndrome. Linear regression followed by multivariable models were used to evaluate associations between DHI log-ins and weight loss or dietary adherence. Results: Participants (n=61) were 79% male (48/61) with mean age of 61.0 (SD 9.7) years. We found a significant positive association of total log-ins during CR with weight loss (r2=.10, P=.03). Educational modules viewed (r2=.11, P=.009) and tasks completed (r2=.10, P=.01) were positively significantly associated with weight loss, yet total log-ins were not significantly associated with differences in dietary adherence (r2=.05, P=.12) or improvements in minutes of exercise per week (r2=.03, P=.36). Conclusions: These data extend our previous findings and demonstrate increased DHI log-ins portend improved weight loss in patients undergoing CR after acute coronary syndrome. DHI adherence can potentially be monitored and used as a tool to selectively encourage patients to adhere to secondary prevention lifestyle modifications. Trial Registration: ClinicalTrials.gov (NCT01883050); https://clinicaltrials.gov/ct2/show/NCT01883050 %M 32130116 %R 10.2196/13055 %U http://www.jmir.org/2020/2/e13055/ %U https://doi.org/10.2196/13055 %U http://www.ncbi.nlm.nih.gov/pubmed/32130116 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 2 %P e13001 %T Online Self-Management Support for Family Caregivers Dealing With Behavior Changes in Relatives With Dementia (Part 2): Randomized Controlled Trial %A Huis in het Veld,Judith G %A Willemse,Bernadette M %A van Asch,Iris FM %A Groot Zwaaftink,Rob BM %A Verkade,Paul-Jeroen %A Twisk,Jos WR %A Verkaik,Renate %A Blom,Marco M %A van Meijel,Berno %A Francke,Anneke L %+ Department of Public and Occupational Health, Amsterdam University Medical Center, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, Amsterdam, , Netherlands, 31 20 44 45 365, Judith.huisinhetveld@inholland.nl %K dementia %K family caregivers %K self-management %K support %K intervention %D 2020 %7 25.2.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Online contacts with a health professional have the potential to support family caregivers of people with dementia. Objective: The goal of the research was to study the effects of an online self-management support intervention in helping family caregivers deal with behavior changes of a relative with dementia. The intervention—involving among others personal email contacts with a dementia nurse—was compared with online interventions without these email contacts. Methods: A randomized controlled trial was conducted with 81 family caregivers of people with dementia who live at home. Participants were randomly assigned to a (1) major self-management support intervention consisting of personal email contacts with a specialist dementia nurse, online videos, and e-bulletins; (2) medium intervention consisting only of online videos and e-bulletins; or (3) minor intervention consisting of only the e-bulletins. The primary outcome was family caregivers’ self-efficacy in dealing with behavior changes of the relative with dementia. Secondary outcomes were family caregivers’ reports of behavior problems in the people with dementia and the quality of the relationship between the family caregiver and the person with dementia. Measurements were performed at the baseline and at 6 (T1) and 12 weeks (T2) after the baseline. A mixed-model analysis was conducted to compare the outcomes of the 3 intervention arms. Results: Family caregivers participating in the major intervention involving email contacts showed no statistically significant differences in self-efficacy after the intervention compared with the minor intervention involving only e-bulletins (difference –0.02, P=.99). In the adjusted analysis, the medium intervention (involving videos and e-bulletins) showed a negative trend over time (difference –4.21, P=.09) and at T1 (difference –4.71, P=.07) compared with the minor intervention involving only e-bulletins. No statistical differences were found between the intervention arms in terms of the reported behavior problems and the quality of the relationship between the family caregiver and the person with dementia. Conclusions: The expectation that an online self-management support intervention involving email contacts would lead to positive effects and be more effective than online interventions without personal email contacts was not borne out. One explanation might be related to the fact that not all family caregivers who were assigned to that intervention actually made use of the opportunity for personal email contact. The online videos were also not always viewed. To obtain more definite conclusions, future research involving extra efforts to reach higher use rates is required. Trial Registration: Netherlands Trial Registry NTR6237; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6237 (Archived by WebCite at http://www.webcitation.org/6v0S4fxTC) International Registered Report Identifier (IRRID): RR2-10.2196/resprot.8365 %M 32130142 %R 10.2196/13001 %U http://www.jmir.org/2020/2/e13001/ %U https://doi.org/10.2196/13001 %U http://www.ncbi.nlm.nih.gov/pubmed/32130142 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 2 %P e16715 %T Effect of a WeChat-Based Intervention (Run4Love) on Depressive Symptoms Among People Living With HIV in China: Randomized Controlled Trial %A Guo,Yan %A Hong,Y Alicia %A Cai,Weiping %A Li,Linghua %A Hao,Yuantao %A Qiao,Jiaying %A Xu,Zhimeng %A Zhang,Hanxi %A Zeng,Chengbo %A Liu,Cong %A Li,Yiran %A Zhu,Mengting %A Zeng,Yu %A Penedo,Frank J %+ Department of Health Administration and Policy, College of Health and Human Services, George Mason University, 4400 University Dr MS 1J3, Fairfax, VA, United States, 1 7039931929, yhong22@gmu.edu %K HIV %K depression %K mHealth %K WeChat %K randomized controlled trial %D 2020 %7 11.2.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: People living with HIV (PLWH) have high rates of depressive symptoms. However, only a few effective mental health interventions exist for this vulnerable population. Objective: The aim of this study was to assess the efficacy of a WeChat-based intervention, Run4Love, with a randomized controlled trial among 300 people living with HIV and depression (PLWHD) in China. Methods: We recruited PLWH from the HIV outpatient clinic in South China. Participants were screened based on the Center for Epidemiologic Studies-Depression (CES-D) scale. Those who scored 16 or higher were eligible to participate. A total of 300 eligible patients were enrolled. After obtaining informed consent from the participants, completion of a baseline survey, and collection of participants’ hair samples for measuring cortisol, the participants were randomly assigned to an intervention or a control group in a 1:1 ratio. The intervention group received the Run4Love program, delivered via the popular social media app WeChat. Cognitive behavioral stress management courses and weekly reminders of exercise were delivered in a multimedia format. Participants’ progress was monitored with timely and tailored feedback. The control group received usual care and a brochure on nutrition for PLWH. Data were collected at 3, 6, and 9 months. The primary outcome was depression, which was measured by a validated instrument. Results: Participants in the intervention and control groups were comparable at baseline; about 91.3% (139/150), 88.3% (132/150), and 86.7% (130/150) participants completed the 3-, 6-, and 9-month follow-ups, respectively. At the 3-month follow-up, a significant reduction in CES-D score was observed in the intervention group (from 23.9 to 17.7 vs from 24.3 to 23.8; mean difference=−5.77, 95% CI −7.82 to −3.71; P<.001; standard effect size d=0.66). The mean changes in CES-D score from baseline to the 6- and 9-month follow-ups between the two groups remained statistically significant. No adverse events were reported. Conclusions: The WeChat-based mobile health (mHealth) intervention Run4Love significantly reduced depressive symptoms among PLWHD, and the effect was sustained. An app-based mHealth intervention could provide a feasible therapeutic option for many PLWHD in resource-limited settings. Further research is needed to assess generalizability and cost-effectiveness of this intervention. Trial Registration: Chinese Clinical Trial Registry ChiCTR-IPR-17012606; http://www.chictr.org.cn/showproj.aspx?proj=21019 (Archived by WebCite at https://www.webcitation.org/78Bw2vouF) %R 10.2196/16715 %U https://www.jmir.org/2020/2/e16715 %U https://doi.org/10.2196/16715 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 2 %P e15125 %T Impact of a Knowledge Translation Intervention on Physical Activity and Mobility in Older Adults (the Move4Age Study): Randomized Controlled Trial %A Neil-Sztramko,Sarah %A Smith-Turchyn,Jenna %A Richardson,Julie %A Dobbins,Maureen %+ School of Nursing, McMaster University, 1280 Main St W, Hamilton, ON, L8S 4L8, Canada, 1 9055259140 ext 20459, neilszts@mcmaster.ca %K physical activity %K mobility limitation %K aging %K knowledge translation %K randomized controlled trial %D 2020 %7 11.2.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: The McMaster Optimal Aging Portal (the Portal) was launched in 2014 as a knowledge translation (KT) tool to increase access to evidence-based health information. Objective: The purpose of this study was to understand if and how dissemination of mobility information through the Portal impacts physical activity (PA) in older adults. Methods: In this randomized controlled trial, participants (n=510) were assigned to a 12-week mobility-focused KT intervention or self-serve control group. The intervention included weekly email alerts and a study-specific social media hashtag linking to mobility-focused Portal materials. The control group was able to access the Portal on their own but did not receive targeted KT strategies. Participants completed questionnaires (including the Rapid Assessment of Physical Activity to quantify PA) at baseline, end of the study, and 3-month follow-up. Results: Participants were predominantly female (430/510, 84.3%), mean age 64.7 years, with no baseline differences between groups. Over half (277/510, 54.3%) of the participants were classified as “active” at baseline. There was no significant between-group difference in the PA category. Overall, both groups increased their PA with improvements maintained at 3-month follow-up (P<.001). In planned subgroup analyses, the KT intervention had a significant effect for those with poor or fair baseline self-rated health (P=.03). Conclusions: No differences were found between those who received the targeted intervention and a control group with self-serve access to the Portal, except in subgroups with low self-rated health. Both groups did report increases in PA that were sustained beyond participation in a research study. Findings suggest that different KT strategies may be needed for different types of users, with more intense interventions being most impactful for certain groups (ie, those with lower self-rated health). Trial Registration: ClinicalTrials.gov NCT02947230; https://clinicaltrials.gov/ct2/show/NCT02947230 %M 32044750 %R 10.2196/15125 %U https://www.jmir.org/2020/2/e15125 %U https://doi.org/10.2196/15125 %U http://www.ncbi.nlm.nih.gov/pubmed/32044750 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 7 %N 2 %P e15795 %T Examining the Usage, User Experience, and Perceived Impact of an Internet-Based Cognitive Behavioral Therapy Program for Adolescents With Anxiety: Randomized Controlled Trial %A Radomski,Ashley D %A Bagnell,Alexa %A Curtis,Sarah %A Hartling,Lisa %A Newton,Amanda S %+ Department of Pediatrics, University of Alberta, 3-077 Edmonton Clinic Health Academy, 11405 - 87 Avenue, Edmonton, AB, T6G 1C9, Canada, 1 7802485581, mandi.newton@ualberta.ca %K internet %K cognitive behavioral therapy %K computer-assisted therapy %K anxiety %K adolescents %K clinical effectiveness %K satisfaction %K minimal clinically important difference %K treatment adherence %D 2020 %7 5.2.2020 %9 Original Paper %J JMIR Ment Health %G English %X Background: Internet-based cognitive behavioral therapy (iCBT) increases treatment access for adolescents with anxiety; however, completion rates of iCBT programs are typically low. Understanding adolescents’ experiences with iCBT, what program features and changes in anxiety (minimal clinically important difference [MCID]) are important to them, may help explain and improve iCBT program use and impact. Objective: Within a randomized controlled trial comparing a six-session iCBT program for adolescent anxiety, Being Real, Easing Anxiety: Tools Helping Electronically (Breathe), with anxiety-based resource webpages, we aimed to (1) describe intervention use among adolescents allocated to Breathe or webpages and those who completed postintervention assessments (Breathe or webpage respondents); (2) describe and compare user experiences between groups; and (3) calculate an MCID for anxiety and explore relationships between iCBT use, experiences, and treatment response among Breathe respondents. Methods: Enrolled adolescents with self-reported anxiety, aged 13 to 19 years, were randomly allocated to Breathe or webpages. Self-reported demographics and anxiety symptoms (Multidimensional Anxiety Scale for Children—2nd edition [MASC-2]) were collected preintervention. Automatically-captured Breathe or webpage use and self-reported symptoms and experiences (User Experience Questionnaire for Internet-based Interventions) were collected postintervention. Breathe respondents also reported their perceived change in anxiety (Global Rating of Change Scale [GRCS]) following program use. Descriptive statistics summarized usage and experience outcomes, and independent samples t tests and correlations examined relationships between them. The MCID was calculated using the mean MASC-2 change score among Breathe respondents reporting somewhat better anxiety on the GRCS. Results: Adolescents were mostly female (382/536, 71.3%), aged 16.6 years (SD 1.7), with very elevated anxiety (mean 92.2, SD 18.1). Intervention use was low for adolescents allocated to Breathe (mean 2.2 sessions, SD 2.3; n=258) or webpages (mean 2.1 visits, SD 2.7; n=278), but was higher for Breathe (median 6.0, range 1-6; 81/258) and webpage respondents (median 2.0, range 1-9; 148/278). Total user experience was significantly more positive for Breathe than webpage respondents (P<.001). Breathe respondents reported program design and delivery factors that may have challenged (eg, time constraints and program support) or facilitated (eg, demonstration videos, self-management activities) program use. The MCID was a mean MASC-2 change score of 13.8 (SD 18.1). Using the MCID, a positive treatment response was generated for 43% (35/81) of Breathe respondents. Treatment response was not correlated with respondents’ experiences or use of Breathe (P=.32 to P=.88). Conclusions: Respondents reported positive experiences and changes in their anxiety with Breathe; however, their reports were not correlated with program use. Breathe respondents identified program design and delivery factors that help explain their experiences and use of iCBT and inform program improvements. Future studies can apply our measures to compare user experiences between internet-based interventions, interpret treatment outcomes and improve treatment decision making for adolescents with anxiety. Trial Registration: ClinicalTrials.gov NCT02970734; https://clinicaltrials.gov/ct2/show/NCT02970734 %R 10.2196/15795 %U https://mental.jmir.org/2020/2/e15795 %U https://doi.org/10.2196/15795 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 2 %P e14221 %T Feasibility, Acceptability, and Clinical Effectiveness of a Technology-Enabled Cardiac Rehabilitation Platform (Physical Activity Toward Health-I): Randomized Controlled Trial %A Claes,Jomme %A Cornelissen,Véronique %A McDermott,Clare %A Moyna,Niall %A Pattyn,Nele %A Cornelis,Nils %A Gallagher,Anne %A McCormack,Ciara %A Newton,Helen %A Gillain,Alexandra %A Budts,Werner %A Goetschalckx,Kaatje %A Woods,Catherine %A Moran,Kieran %A Buys,Roselien %+ Department of Rehabilitation Sciences, University of Leuven, Herestraat 49, Bus 1510, Leuven, 3000, Belgium, 32 0486388176, roselien.buys@kuleuven.be %K cardiac rehabilitation %K physical activity %K technology %K eHealth %D 2020 %7 4.2.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Cardiac rehabilitation (CR) is highly effective as secondary prevention for cardiovascular diseases (CVDs). Uptake of CR remains suboptimal (30% of eligible patients), and long-term adherence to a physically active lifestyle is even lower. Innovative strategies are needed to counteract this phenomenon. Objective: The Physical Activity Toward Health (PATHway) system was developed to provide a comprehensive, remotely monitored, home-based CR program for CVD patients. The PATHway-I study aimed to investigate its feasibility and clinical efficacy during phase III CR. Methods: Participants were randomized on a 1:1 basis to the PATHway (PW) intervention group or usual care (UC) control group in a single-blind, multicenter, randomized controlled pilot trial. Outcomes were assessed at completion of phase II CR and 6-month follow-up. The primary outcome was physical activity (PA; Actigraph GT9X link). Secondary outcomes included measures of physical fitness, modifiable cardiovascular risk factors, endothelial function, intima-media thickness of the common carotid artery, and quality of life. System usability and patients’ experiences were evaluated only in PW. A mixed-model analysis of variance with Bonferroni adjustment was used to analyze between-group effects over time. Missing values were handled by means of an intention-to-treat analysis. Statistical significance was set at a 2-sided alpha level of .05. Data are reported as mean (SD). Results: A convenience sample of 120 CVD patients (mean 61.4 years, SD 13.5 years; 22 women) was included. The PATHway system was deployed in the homes of 60 participants. System use decreased over time and system usability was average with a score of 65.7 (SD 19.7; range 5-100). Moderate-to-vigorous intensity PA increased in PW (PW: 127 [SD 58] min to 141 [SD 69] min, UC: 146 [SD 66] min to 143 [SD 71] min; Pinteraction=.04; effect size of 0.42), while diastolic blood pressure (PW: 79 [SD 11] mmHg to 79 [SD 10] mmHg, UC: 78 [SD 9] mmHg to 83 [SD 10] mmHg; Pinteraction=.004; effect size of −0.49) and cardiovascular risk score (PW: 15.9% [SD 10.4%] to 15.5% [SD 10.5%], UC: 14.5 [SD 9.7%] to 15.7% [SD 10.9%]; Pinteraction=.004; effect size of −0.36) remained constant, but deteriorated in UC. Conclusions: This pilot study demonstrated the feasibility and acceptability of a technology-enabled, remotely monitored, home-based CR program. Although clinical effectiveness was demonstrated, several challenges were identified that could influence the adoption of PATHway. Trial Registration: ClinicalTrials.gov NCT02717806; https://clinicaltrials.gov/ct2/show/NCT02717806 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2017-016781 %M 32014842 %R 10.2196/14221 %U https://www.jmir.org/2020/2/e14221 %U https://doi.org/10.2196/14221 %U http://www.ncbi.nlm.nih.gov/pubmed/32014842 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 7 %N 1 %P e13392 %T A Culturally Adapted Cognitive Behavioral Internet-Delivered Intervention for Depressive Symptoms: Randomized Controlled Trial %A Salamanca-Sanabria,Alicia %A Richards,Derek %A Timulak,Ladislav %A Connell,Sarah %A Mojica Perilla,Monica %A Parra-Villa,Yamilena %A Castro-Camacho,Leonidas %+ SilverCloud Health, Clinical Research & Innovation, 1 Stephen St Upper, Dublin 8, DR9P, Ireland, 353 87 9343678, drichard@tcd.ie %K culture %K internet %K cognitive behavioral therapy %K depressive symptoms %K students %K South America %D 2020 %7 31.1.2020 %9 Original Paper %J JMIR Ment Health %G English %X Background: Internet-delivered treatments for depressive symptoms have proved to be successful in high-income Western countries. There may be potential for implementing such treatments in low- and middle-income countries such as Colombia, where access to mental health services is limited. Objective: The objective of this study was to assess the efficacy of a culturally adapted cognitive behavioral internet-delivered treatment for college students with depressive symptoms in Colombia. Methods: This was a randomized controlled trial with a 3-month follow-up. The program comprised seven modules. A total of 214 Colombian college students were recruited. They were assessed and randomly assigned to either the treatment group (n=107) or a waiting list (WL) control group (n=107). Participants received weekly support from a trained supporter. The primary outcome was symptoms of depression, as measured by the Patient Health Questionnaire - 9, and the secondary outcomes were anxiety symptoms assessed by the Generalized Anxiety Disorder questionnaire - 7. Other measures, including satisfaction with treatment, were evaluated after 7 weeks. Results: Research attrition and treatment dropouts were high in this study. On average, 7.6 sessions were completed per user. The mean time spent on the program was 3 hours and 18 min. The linear mixed model (LMM) showed significant effects after treatment (t197.54=−5.189; P<.001) for the treatment group, and these effects were maintained at the 3-month follow-up (t39.62=4.668; P<.001). Within-group results for the treatment group yielded a large effect size post treatment (d=1.44; P<.001), and this was maintained at the 3-month follow-up (d=1.81; P<.001). In addition, the LMM showed significant differences between the groups (t197.54=−5.189; P<.001). The results showed a large effect size between the groups (d=0.91; P<.001). In the treatment group, 76.0% (16/107) achieved a reliable change, compared with 32.0% (17/107) in the WL control group. The difference between groups was statistically significant (X22=10.5; P=.001). Conclusions: This study was the first contribution to investigating the potential impact of a culturally adapted internet-delivered treatment on depressive symptoms for college students as compared with a WL control group in South America. Future research should focus on identifying variables associated both with premature dropout and treatment withdrawal at follow-up. Trial Registration: ClinicalTrials.gov NCT03062215; https://clinicaltrials.gov/ct2/show/NCT03062215 %M 32003749 %R 10.2196/13392 %U https://mental.jmir.org/2020/1/e13392 %U https://doi.org/10.2196/13392 %U http://www.ncbi.nlm.nih.gov/pubmed/32003749 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 1 %P e16253 %T An Interactive Web-Based Lethal Means Safety Decision Aid for Suicidal Adults (Lock to Live): Pilot Randomized Controlled Trial %A Betz,Marian E %A Knoepke,Christopher E %A Simpson,Scott %A Siry,Bonnie J %A Clement,Ashley %A Saunders,Tamara %A Johnson,Rachel %A Azrael,Deborah %A Boudreaux,Edwin D %A Omeragic,Faris %A Adams,Leah M %A Almond,Sydney %A Juarez-Colunga,Elizabeth %A Matlock,Daniel D %+ Department of Emergency Medicine, University of Colorado School of Medicine, 12401 E 17th Avenue, B-215, Aurora, CO, 80045, United States, 1 7208486777, marian.betz@cuanschutz.edu %K internet %K firearm %K suicide %K medication %D 2020 %7 29.1.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Counseling to reduce access to lethal means such as firearms and medications is recommended for suicidal adults but does not routinely occur. We developed the Web-based Lock to Live (L2L) decision aid to help suicidal adults and their families choose options for safer home storage. Objective: This study aimed to test the feasibility and acceptability of L2L among suicidal adults in emergency departments (EDs). Methods: At 4 EDs, we enrolled participants (English-speaking, community-dwelling, suicidal adults) in a pilot randomized controlled trial. Participants were randomized in a 13:7 ratio to L2L or control (website with general suicide prevention information) groups and received a 1-week follow-up telephone call. Results: Baseline characteristics were similar between the intervention (n=33) and control (n=16) groups. At baseline, many participants reported having access to firearms (33/49, 67%), medications (46/49, 94%), or both (29/49, 59%). Participants viewed L2L for a median of 6 min (IQR 4-10 min). L2L also had very high acceptability; almost all participants reported that they would recommend it to someone in the same situation, that the options felt realistic, and that L2L was respectful of values about firearms. In an exploratory analysis of this pilot trial, more participants in the L2L group reported reduced firearm access at follow-up, although the differences were not statistically significant. Conclusions: The L2L decision aid appears feasible and acceptable for use among adults with suicide risk and may be a useful adjunct to lethal means counseling and other suicide prevention interventions. Future large-scale studies are needed to determine the effect on home access to lethal means. Trial Registration: ClinicalTrials.gov NCT03478501; https://clinicaltrials.gov/ct2/show/NCT03478501 %M 32012056 %R 10.2196/16253 %U http://www.jmir.org/2020/1/e16253/ %U https://doi.org/10.2196/16253 %U http://www.ncbi.nlm.nih.gov/pubmed/32012056 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 1 %P e15438 %T A Web-Based, Computer-Tailored Intervention to Reduce Alcohol Consumption and Binge Drinking Among Spanish Adolescents: Cluster Randomized Controlled Trial %A Martinez-Montilla,José Manuel %A Mercken,Liesbeth %A de Vries,Hein %A Candel,Math %A Lima-Rodríguez,Joaquín Salvador %A Lima-Serrano,Marta %+ Department of Nursing, School of Nursing, Physiotherapy and Podiatry, University of Seville, Street Avenzoar nº 6, Seville, 41009, Spain, 34 669955295, josmarmon3@alum.us.es %K adolescents %K alcohol consumption %K binge drinking %K cluster randomized controlled trial %K computer tailoring %D 2020 %7 24.1.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Alcohol consumption, including binge drinking (BD) and heavy episodic drinking (HED), is one of the leading risk factors among Spanish adolescents leading to significant social, health, and economic consequences. Reduction of BD and HED in adolescents can be achieved using Web-based, computer-tailored (CT) interventions, providing highly personalized feedback that is adapted to a person’s individual characteristics and needs. Randomized controlled trials assessing the effects of tailored BD reduction programs among Spanish adolescents are scarce. Objective: The aim of this study was to test the effectiveness of the Web-based, CT intervention Alerta Alcohol, aimed at the prevention of BD in Spanish adolescents. As a secondary outcome, effects on HED, weekly consumption, and any consumption were also assessed. The adherence and process evaluation were assessed. Methods: A cluster randomized controlled trial conducted among 15 Spanish schools was developed. Each school was randomized into either an experimental condition (EC) (N=742) or a control condition (CC) (N=505). Finally, 351 participants for the EC and 261 for the CC were included in the analysis (N=612). Baseline assessment took place in January and February 2017. Demographic variables and alcohol use were assessed at baseline. Follow-up assessment of alcohol use took place 4 months later in May and June 2017. Participants were compared according to their randomization group (EC versus CC). After the baseline assessment, participants in the EC started the intervention, which consisted of short stories about BD, in which CT feedback was based on the I-Change Model for behavior change. Participants in the CC group only received the baseline questionnaire. Effects of the intervention were assessed using a three-level mixed logistic regression analysis for BD, HED, and any consumption, and a three-level mixed linear regression analysis for weekly consumption. Results: In total, 1247 adolescents participated in the baseline assessment and 612 participated in the follow-up assessment; the attrition rate was 50.92%. The intervention was effective in reducing HED among adolescents; the odds of HED in the CC was nine times that in the experimental condition (P=.04). No effects were found for BD, weekly consumption, and any consumption. Process evaluations revealed that the adolescents were satisfied with the program (68.8%), would use the program again (52.9%), and would recommend it to someone else (62.8%). Females and non-binge drinkers showed better responses in the process evaluation. Conclusions: Our intervention was effective regarding HED but not regarding BD, weekly consumption, and any consumption. It may be that limiting alcohol consumption to prevent HED was easier in the Spanish context than it was to carry out further steps, such as reducing other patterns of alcohol consumption. Hence, additional actions are needed to accomplish these latter goals, including community approaches and policy actions aimed at denormalizing alcohol consumption among Spanish adolescents. Trial Registration: ClinicalTrials.gov NCT03288896; https://clinicaltrials.gov/ct2/show/NCT03288896 International Registered Report Identifier (IRRID): RR2-10.1186/s12889-018-5346-4 %M 32012064 %R 10.2196/15438 %U http://www.jmir.org/2020/1/e15438/ %U https://doi.org/10.2196/15438 %U http://www.ncbi.nlm.nih.gov/pubmed/32012064 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 1 %P e13077 %T Digital Competencies and Attitudes Toward Digital Adherence Solutions Among Elderly Patients Treated With Novel Anticoagulants: Qualitative Study %A Herrmann,Maximilian %A Boehme,Philip %A Hansen,Arne %A Jansson,Katharina %A Rebacz,Patrick %A Ehlers,Jan P %A Mondritzki,Thomas %A Truebel,Hubert %+ Research & Development, Pharmaceuticals, Bayer Aktiengesellschaft, Apratherweg 18, Wuppertal, 42113, Germany, 49 202360, hubert.truebel@bayer.com %K medication adherence %K eHealth %K mHealth %K digital health %K smartphone %K elderly patients %K compliance %K digital device %K digital competencies %K grounded theory %K delivery of health care %K diffusion of innovation %D 2020 %7 24.1.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Nonadherence to medication is a driver of morbidity and mortality, and complex medication regimens in patients with chronic diseases foster the problem. Digital technology might help, but despite numerous solutions being developed, none are currently widely used, and acceptance rates remain low, especially among the elderly. Objective: This study aimed to better understand and operationalize how new digital solutions can be evaluated. Particularly, the goal was to identify factors that help digital approaches targeting adherence to become more widely accepted. Methods: A qualitative study using a conceptual grounded theory approach was conducted. We included patients aged 65 years and older who routinely took new oral anticoagulants. To generate theses about the digital competencies of the target group with daily medication intake, face-to-face interviews were conducted, recorded, and anonymized. After coding the interviews, categories were generated, discussed, and combined with several theses until saturation of the statements was reached. Results: The methodological approach led to the finding that after interviews in 20 of 77 potentially available patients, a saturation of statements was reached. The average patient’s age was 75 years, and 50% (10/20) of the subjects were female. The data identified five main coding categories—Diseases and medicine, Technology, Autonomy, Patient narrative, and Attitude toward technologies—each including positive and negative subcategories. Main categories and subcategories were summarized as Adherence Radar, which can be considered as a framework to assess the potential of adherence solutions in the process of prototyping and can be applied to all adherence tools in a holistic manner. Conclusions: The Adherence Radar can be used to increase the acceptance rate of digital solutions targeting adherence. For a patient-centric design, an app should be adapted to the individual patient’s needs. According to our results, this application should be based on gender and educational background as well as the individual physician-patient relationship. If used in a proper, individualized manner, digital adherence solutions could become a new cornerstone for the treatment of chronically ill individuals. %M 32012049 %R 10.2196/13077 %U http://www.jmir.org/2020/1/e13077/ %U https://doi.org/10.2196/13077 %U http://www.ncbi.nlm.nih.gov/pubmed/32012049 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 1 %P e14580 %T A Context-Specific Digital Alcohol Brief Intervention in Symptomatic Breast Clinics (Abreast of Health): Development and Usability Study %A Sinclair,Julia M A %A Dutey-Magni,Peter F %A Anderson,Annie S %A Baird,Janis %A Barker,Mary E %A Cutress,Ramsey I %A Kaner,Eileen F S %A McCann,Mark %A Priest,Caspian K %A Copson,Ellen R %+ Faculty of Medicine, University of Southampton, Academic Centre, College Keep, 4-12 Terminus Terrace, Southampton, SO14 3DT, United Kingdom, 44 (023) 8231 0779, julia.sinclair@soton.ac.uk %K cancer %K information seeking behavior %K health risk behaviors %K secondary prevention %K alcohol drinking %K health knowledge %K attitudes %K practice %K health promotion %K health literacy %D 2020 %7 24.1.2020 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Potentially modifiable risk factors account for approximately 23% of breast cancer cases. In the United Kingdom, alcohol consumption alone is held responsible for 8% to 10% of cases diagnosed every year. Symptomatic breast clinics focus on early detection and treatment, but they also offer scope for delivery of low-cost lifestyle interventions to encourage a cancer prevention culture within the cancer care system. Careful development work is required to effectively translate such interventions to novel settings. Objective: The aim of this study was to develop a theory of change and delivery mechanism for a context-specific alcohol and lifestyle brief intervention aimed at women attending screening and symptomatic breast clinics. Methods: A formative study combined evidence reviews, analysis of mixed method data, and user experience research to develop an intervention model, following the 6 Steps in Quality Intervention Development (6SQuID) framework. Results: A Web app focused on improving awareness, encouraging self-monitoring, and reframing alcohol reduction as a positive choice to improve health was found to be acceptable to women. Accessing this in the clinic waiting area on a tablet computer was shown to be feasible. An important facilitator for change may be the heightened readiness to learn associated with a salient health visit (a teachable moment). Women may have increased motivation to change if they can develop a belief in their capability to monitor and, if necessary, reduce their alcohol consumption. Conclusions: Using the 6SQuID framework supported the prototyping and maximized acceptability and feasibility of an alcohol brief intervention for women attending symptomatic breast clinics, regardless of their level of alcohol consumption. %M 32012091 %R 10.2196/14580 %U https://www.researchprotocols.org/2020/1/e14580 %U https://doi.org/10.2196/14580 %U http://www.ncbi.nlm.nih.gov/pubmed/32012091 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 1 %P e15057 %T Efficacy of an Electronic Health Management Program for Patients With Cardiovascular Risk: Randomized Controlled Trial %A Yun,Young Ho %A Kang,EunKyo %A Cho,Young Min %A Park,Sang Min %A Kim,Yong-Jin %A Lee,Hae-Young %A Kim,Kyae Hyung %A Lee,Kiheon %A Koo,Hye Yeon %A Kim,Soojeong %A Rhee,YeEun %A Lee,Jihye %A Min,Jeong Hee %A Sim,Jin-Ah %+ Seoul National University College of Medicine, Department of Family Medicine, 103 Daehak-Ro, Jongno-Gu, Seoul, 03080, Republic of Korea, 82 27408417, lawyun@snu.ac.kr %K health %K hypertension %K diabetes %K hypercholesterolemia %K randomized controlled trial %D 2020 %7 22.1.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: In addition to medication, health behavior management is crucial in patients with multiple risks of cardiovascular mortality. Objective: This study aimed to examine the efficacy of a 3-month Smart Management Strategy for Health–based electronic program (Smart Healthing). Methods: A 2-arm randomized controlled trial was conducted to assess the efficacy of Smart Healthing in 106 patients with at least one indicator of poor disease control and who had hypertension, diabetes, or hypercholesterolemia. The intervention group (n=53) took part in the electronic program, which was available in the form of a mobile app and a Web-based PC application. The program covered 4 areas: self-assessment, self-planning, self-learning, and self-monitoring by automatic feedback. The control group (n=53) received basic educational material concerning disease control. The primary outcome was the percentage of participants who achieved their clinical indicator goal after 12 weeks into the program: glycated hemoglobin (HbA1c) <7.0%, systolic blood pressure (SBP) <140 mmHg, or low-density lipoprotein cholesterol <130 mg/dL. Results: The intervention group showed a significantly higher success rate (in comparison with the control group) for achieving each of 3 clinical indicators at the targeted goal levels (P<.05). Only the patients with hypertension showed a significant improvement in SBP from the baseline as compared with the control group (72.7% vs 35.7%; P<.05). There was a significant reduction in HbA1c in the intervention group compared with the control group (difference=0.54%; P≤.05). In the intervention group, 20% of patients with diabetes exhibited a ≥1% decrease in HbA1c (vs 0% among controls; P≤.05). Conclusions: A short-term self-management strategy-based electronic program intervention may improve clinical outcomes among patients with cardiovascular risks. Trial Registration: ClinicalTrials.gov NCT03294044; https://clinicaltrials.gov/ct2/show/NCT03294044 %M 32012053 %R 10.2196/15057 %U https://www.jmir.org/2020/1/e15057 %U https://doi.org/10.2196/15057 %U http://www.ncbi.nlm.nih.gov/pubmed/32012053 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 1 %P e14780 %T A Web-Based Communication Platform to Improve Home Care Services in Norway (DigiHelse): Pilot Study %A Støme,Linn Nathalie %A Moger,Tron %A Kidholm,Kristian %A Kværner,Kari J %+ Centre for Connected Care, Oslo University Hospital, Kirkeveien 166, Oslo, , Norway, 47 94880825, linast@ous-hf.no %K early health technology assessment %K eHealth %K primary care %K innovation %K behavioral data %D 2020 %7 20.1.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: Home care service in Norway is struggling to meet the increasing demand for health care under restricted budget constraints, although one-fourth of municipal budgets are dedicated to health services. The integration of Web-based technology in at-home care is expected to enhance communication and patient involvement, increase efficiency and reduce cost. DigiHelse is a Web-based platform designed to reinforce home care service in Norway and is currently undergoing a development process to meet the predefined needs of the country’s municipalities. Some of the main features of the platform are digital messages between residents and the home care service, highlighting information on planned and completed visits, the opportunity to cancel visits, and notifications for completed visits. Objective: This study aimed to test the usability and economic feasibility of adopting DigiHelse in four districts in Oslo by applying registry and behavioral data collected throughout a one-year pilot study. Early health technology assessment was used to estimate the potential future value of DigiHelse, including the predictive value of behavior data. Methods: Outcome measures identified by stakeholder insights and scenario drafting in the project’s concept phase were used to assess potential socioeconomic benefits. Aggregated data were collected to assess changes in health consumption at baseline, and then 15 and 52 weeks after DigiHelse was implemented. The present value calculation was updated with data from four intervention groups and one control group. A quasi-experimental difference-in-difference design was applied to estimate the causal effect. Descriptive behavioral data from the digital platform was applied to assess the usability of the platform. Results: Over the total study period (52 weeks), rates increased for all outcome estimates: the number of visits (rate ratio=1.04; P=.10), unnecessary trips (rate ratio=1.37; P=.26), and phone calls (rate ratio=1.24; P=.08). A significant gap was found between the estimated value of DigiHelse in the concept phase and after the one-year pilot. In the present pilot assessment, costs are expected to exceed potential savings by €67 million (US $75 million) over ten years, as compared to the corresponding concept estimates of a potential gain of €172.6 million (US $193.6 million). Interestingly, behavioral data from the digital platform revealed that only 3.55% (121/3405) of recipients actively used the platform after one year. Conclusions: Behavioral data provides a valuable source for assessing usability. In this pilot study, the low adoption rate may, at least in part, explain the inability of DigiHelse to perform as expected. This study points to an early assessment of behavioral data as an opportunity to identify inefficiencies and direct digital development. For DigiHelse, insight into why the recipients in Oslo have not made greater use of the Web-based platform seems to be the next step in ensuring the right improvement measures for the home care service. %M 31958062 %R 10.2196/14780 %U http://formative.jmir.org/2020/1/e14780/ %U https://doi.org/10.2196/14780 %U http://www.ncbi.nlm.nih.gov/pubmed/31958062 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 1 %P e14551 %T Tools for App- and Web-Based Self-Testing of Cognitive Impairment: Systematic Search and Evaluation %A Charalambous,Anna Pavlina %A Pye,Annie %A Yeung,Wai Kent %A Leroi,Iracema %A Neil,Malcolm %A Thodi,Chryssoula %A Dawes,Piers %+ Manchester Centre for Audiology and Deafness, University of Manchester and the Manchester Academic Health Sciences Centre, A3.09 Ellen Wilkinson Building, Manchester, M13 9PL, United Kingdom, 44 1613061758, piers.dawes@manchester.ac.uk %K telemedicine %K eHealth %K mHealth %K dementia %K mild cognitive impairment %K self-assessment %D 2020 %7 17.1.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Tools for app- and Web-based self-testing for identification of cognitive impairment are widely available but are of uncertain quality. Objective: The objective of this study was to undertake a scoping review of app- and Web-based self-tests for cognitive impairment and determine the validity of these tests. Methods: We conducted systematic searches in electronic databases, including Google search, Google Play Store, and iPhone Operating System App Store, using the search terms “Online OR Internet-based AND Memory OR Brain OR Dementia OR mild cognitive impairment OR MCI AND Test OR Screen OR Check.” Results: We identified 3057 tools, of which 25 were included in the review. Most tools meeting the inclusion criteria assessed multiple cognitive domains. The most frequently assessed domains were memory, attention, and executive function. We then conducted an electronic survey with the developers of the tools to identify data relating to development and validation of each tool. If no response to the survey was received, Google (to identify gray literature), Google Scholar, and Medical Literature Analysis and Retrieval System Online were searched using key terms “(name of developer, if available)” AND “(the name of the tool)” to identify any additional data. Only 7 tools had any information concerning psychometric quality, and only 1 tool reported data on performance norms, reliability, validity, sensitivity, and specificity for the detection of cognitive impairment. Conclusions: The number of cognitive self-assessment electronic health tools for cognitive impairment is increasing, but most are of uncertain quality. There is a need for well-validated tools and guidance for users concerning which tools provide reliable information about possible cognitive impairment that could warrant further investigation. %M 31951218 %R 10.2196/14551 %U https://www.jmir.org/2020/1/e14551 %U https://doi.org/10.2196/14551 %U http://www.ncbi.nlm.nih.gov/pubmed/31951218 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 1 %P e15793 %T A Culturally Targeted eLearning Module on Organ Donation (Promotoras de Donación): Design and Development %A Alolod,Gerard P %A Gardiner,Heather %A Agu,Chidera %A Turner,Jennie L %A Kelly,Patrick J %A Siminoff,Laura A %A Gordon,Elisa J %A Norden,Robert %A Daly,Theresa A %A Benitez,Amanda %A Hernandez,Ilda %A Guinansaca,Nancy %A Winther,Lori Ramos %A Bergeron,Caroline D %A Montalvo,Antonette %A Gonzalez,Tony %+ College of Public Health, Temple University, 1700 N Broad St, Suite 417, Philadelphia, PA, 19121, United States, 1 2152049186, gpalolod@temple.edu %K Hispanic Americans %K organ donation %K program development %K program evaluation %K education %D 2020 %7 13.1.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: As an overrepresented population on the transplant waitlist, stagnated rates of organ donation registration among Latinxs must be redressed. Promotoras (community health workers), who are effective at advocating and spearheading health promotion efforts in the Latinx community, show promise in their ability to educate about organ donation and donor registration. Objective: This study aimed (1) to develop an interactive, evidence-based program to educate promotoras about organ donation, the need for organ donors in the Latinx American community, and ways to register as deceased organ donors and (2) to train promotoras to lead discussions about organ donation and to promote the act of donor registration. Methods: In partnership with 4 promotoras organizations, the culturally targeted Promotoras de Donación eLearning module was developed based on input from 12 focus groups conducted with Latina women (n=61) and promotoras (n=37). Formative work, existing literature, the Vested Interest Theory, and the Organ Donation Model guided curriculum development. In partnership with the Gift of Life Institute and regional promotoras, the curriculum was designed, filmed, and developed in a visually appealing module interface. The module was beta-tested with promotoras before launch. Results: Promotoras de Donación, available in Spanish with English subtitling, lasts just over an hour. The module comprised 6 sections including various activities and videos, with the curriculum divided into a skills-based communication component and a didactic educational component. Pre- and posttests assessed the module’s direct effects on promotoras’ organ donation knowledge and attitudes as well as confidence promoting the act of donor registration. Conclusions: This novel, theoretically and empirically based intervention leveraged the existing network of promotoras to promote the act of donor registration. Future research should assess whether the module helps increase rates of donor registration within Latinx communities and reduce disparities in access to transplantation. Trial Registration: ClinicalTrials.gov NCT04007419; https://www.clinicaltrials.gov/ct2/show/NCT04007419 %M 31929102 %R 10.2196/15793 %U https://www.jmir.org/2020/1/e15793 %U https://doi.org/10.2196/15793 %U http://www.ncbi.nlm.nih.gov/pubmed/31929102 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 1 %P e16804 %T Effectiveness and Cost-Effectiveness of a Self-Guided Internet Intervention for Social Anxiety Symptoms in a General Population Sample: Randomized Controlled Trial %A Powell,John %A Williams,Veronika %A Atherton,Helen %A Bennett,Kylie %A Yang,Yaling %A Davoudianfar,Mina %A Hellsing,Annika %A Martin,Angela %A Mollison,Jill %A Shanyinde,Milensu %A Yu,Ly-Mee %A Griffiths,Kathleen M %+ Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, United Kingdom, 44 1865617768, john.powell@phc.ox.ac.uk %K randomized controlled trial %K internet %K self-care %K social anxiety %D 2020 %7 10.1.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Many people are accessing digital self-help for mental health problems, often with little evidence of effectiveness. Social anxiety is one of the most common sources of mental distress in the population, and many people with symptoms do not seek help for what represents a significant public health problem. Objective: This study aimed to evaluate the effectiveness of a self-guided cognitive behavioral internet intervention for people with social anxiety symptoms in the general population. Methods: We conducted a two-group randomized controlled trial in England between May 11, 2016, and June 27, 2018. Adults with social anxiety symptoms who were not receiving treatment for social anxiety were recruited using online advertisements. All participants had unrestricted access to usual care and were randomized in a 1:1 ratio to either a Web-based unguided self-help intervention based on cognitive behavioral principles or a waiting list control group. All outcomes were collected through self-report online questionnaires. The primary outcome was the change in 17-item Social Phobia Inventory (SPIN-17) score from baseline to 6 weeks using a linear mixed-effect model that used data from all time points (6 weeks, 3 months, 6 months, and 12 months). Results: A total of 2122 participants were randomized, and 6 were excluded from analyses because they were ineligible. Of the 2116 eligible randomized participants (mean age 37 years; 80.24%, 1698/2116 women), 70.13% (1484/2116) had follow-up data available for analysis, and 56.95% (1205/2116) had data on the primary outcome, although attrition was higher in the intervention arm. At 6 weeks, the mean (95% CI) adjusted difference in change in SPIN-17 score in the intervention group compared with control was −1.94 (−3.13 to −0.75; P=.001), a standardized mean difference effect size of 0.2. The improvement was maintained at 12 months. Given the high dropout rate, sensitivity analyses explored missing data assumptions, with results that were consistent with those of the primary analysis. The economic evaluation demonstrated cost-effectiveness with a small health status benefit and a reduction in health service utilization. Conclusions: For people with social anxiety symptoms who are not receiving other forms of help, this study suggests that the use of an online self-help tool based on cognitive behavioral principles can provide a small improvement in social anxiety symptoms compared with no intervention, although dropout rates were high. Trial Registration: ClinicalTrials.gov NCT02451878; https://clinicaltrials.gov/ct2/show/NCT02451878 %M 31821151 %R 10.2196/16804 %U http://www.jmir.org/2020/1/e16804/ %U https://doi.org/10.2196/16804 %U http://www.ncbi.nlm.nih.gov/pubmed/31821151 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 1 %P e16211 %T The Effects of a Digital Well-Being Intervention on Patients With Chronic Conditions: Observational Study %A Parks,Acacia C %A Williams,Allison L %A Kackloudis,Gina M %A Stafford,Julia L %A Boucher,Eliane M %A Honomichl,Ryan D %+ Happify, 51 East 12th Street, 5th Floor, New York, NY, 10003, United States, 1 2678798387, acacia@happify.com %K chronic illness %K happiness %K subjective well-being %K psychology, positive %K internet-based intervention %K mobile apps %D 2020 %7 10.1.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic conditions account for 75% of health care costs, and the impact of chronic illness is expected to grow over time. Although subjective well-being predicts better health outcomes, people with chronic conditions tend to report lower well-being. Improving well-being might mitigate costs associated with chronic illness; however, existing interventions can be difficult to access and draw from a single theoretical approach. Happify, a digital well-being intervention program drawing from multiple theoretical traditions to target well-being, has already been established as an efficacious means of improving well-being in both distressed and nondistressed users. Objective: This study aimed to compare change in well-being over time after using Happify for users with and without a chronic condition. Methods: Data were obtained from Happify users, a publicly available digital well-being program accessible via website or mobile phone app. Users work on tracks addressing a specific issue (eg, conquering negative thoughts) composed of games and activities based on positive psychology, cognitive behavioral therapy, and mindfulness principles. The sample included 821 users receiving at least 6 weeks’ exposure to Happify (ranging from 42 to 179 days) who met other inclusion criteria. As part of a baseline questionnaire, respondents reported demographic information (age and gender) and whether they had any of the prespecified chronic conditions: arthritis, diabetes, insomnia, multiple sclerosis, chronic pain, psoriasis, eczema, or some other condition (450 reported a chronic condition, whereas 371 did not). Subjective well-being was assessed with the Happify Scale, a 9-item measure of positive emotionality and life satisfaction. To evaluate changes in well-being over time, a mixed effects linear regression model was fit for subjective well-being, controlling for demographics and platform usage. Results: At baseline, users with a chronic condition had significantly lower subjective well-being (mean 38.34, SD 17.40) than users without a chronic condition (mean 43.65, SD 19.13). However, change trajectories for users with or without a chronic condition were not significantly different; both groups experienced equivalent improvements in well-being. We also found an effect for time from baseline (b=0.071; SE=0.010; P<.01) and number of activities completed (b=0.03; SE=0.009; P<.01), and a 2-way interaction between number of activities completed and time from baseline (b=0.0002; SE=0.00006; P<.01), such that completing more activities and doing so over increasingly longer periods produced improved well-being scores. Conclusions: Data from this study support the conclusion that users with a chronic condition experienced significant improvement over time. Despite reporting lower subjective well-being on the whole, their change trajectory while using Happify was equivalent to those without a chronic condition. Consistent with past research, users who completed more activities over a longer period showed the most improvement. In short, the presence of a chronic condition did not prevent users from showing improved well-being when using Happify. %M 31922491 %R 10.2196/16211 %U https://www.jmir.org/2020/1/e16211 %U https://doi.org/10.2196/16211 %U http://www.ncbi.nlm.nih.gov/pubmed/31922491 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 3 %N 1 %P e15813 %T A Web-Based Intervention for Youth With Physical Disabilities: Comparing the Role of Mentors in 12- and 4-Week Formats %A Lindsay,Sally %A Cagliostro,Elaine %+ Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Road, Toronto, ON, M4G 1R8, Canada, 1 416 525 6220 ext 3654, slindsay@hollandbloorview.ca %K social support %K mentor %K youth %K adolescent %K employment %D 2020 %7 8.1.2020 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Youths with physical disabilities face many barriers in society, including social exclusion, stigma, and difficulties finding employment. Electronic mentoring (e-mentoring) offers a promising opportunity for youths with disabilities and has the potential to improve their inclusion while enhancing career outcomes. However, little is known about the role of mentors in a Web-based e-mentoring format to improve employment outcomes. Objective: This study aimed to explore the role of mentors in engaging youths in an e-mentoring intervention and to compare and contrast mentors’ engagement strategies within a 12- and 4-week format. Methods: This paper drew on a pilot feasibility study, which is a group, Web-based employment readiness intervention involving a discussion forum for youths with physical disabilities. Our intervention involved having trained youth mentors (ie, near-peers who also had a disability) lead Web-based discussion forums while offering peer support and resources, which involved 12 modules completed over both a 12- or 4-week format. We used a mixed method approach including qualitative data (mentor interviews and discussion forum data) and quantitative data (pre-post survey data) comparison. Results: A total of 24 youths participated across 3 e-mentoring intervention groups: 9 in the 12-week format (mean age 17.7 years [SD 1.7]) and 15 in the 4-week format (mean age 19.5 years [SD 2.6]), led by 3 trained youth mentors with disabilities, 2 males and 1 female (mean age 22 years [SD 2.64]). Our findings revealed that mentors engaged youths in the e-mentoring program by providing informational, emotional, and tangible support. We noted more instances of mentors providing advice, empathy, and encouragement in the 12-week format compared with the 4-week format. We also found fewer examples of providing advice, developing a rapport, and social support from mentors in the 4-week format. Our findings revealed no significant differences between the 2 groups regarding time spent in the forum, number of logins, number of posts, and self-rated engagement. Conclusions: Mentors in the 12-week and 4-week format engaged participants differently in providing informational and emotional support, although there were no differences in tangible support provided. Mentors reported that the 12-week format was too long and lacked interaction between participants, whereas the 4-week format felt rushed and had fewer detailed responses from mentees. International Registered Report Identifier (IRRID): RR2-10.2196/resprot.8034 %M 31913132 %R 10.2196/15813 %U https://pediatrics.jmir.org/2020/1/e15813 %U https://doi.org/10.2196/15813 %U http://www.ncbi.nlm.nih.gov/pubmed/31913132 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 1 %P e15445 %T Self-Care Monitoring of Heart Failure Symptoms and Lung Impedance at Home Following Hospital Discharge: Longitudinal Study %A Aamodt,Ina Thon %A Lycholip,Edita %A Celutkiene,Jelena %A von Lueder,Thomas %A Atar,Dan %A Falk,Ragnhild Sørum %A Hellesø,Ragnhild %A Jaarsma,Tiny %A Strömberg,Anna %A Lie,Irene %+ Centre for Patient-Centered Heart and Lung Research, Department of Cardiothoracic Surgery, Oslo University Hospital, Ullevål, Building 63, Box 4956 Nydalen, Oslo, Norway, 47 48090883, inamarieaamodt@gmail.com %K heart failure %K telemedicine %K lung impedance %K diary %K self-care %K prospective study %D 2020 %7 7.1.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Self-care is key to the daily management of chronic heart failure (HF). After discharge from hospital, patients may struggle to recognize and respond to worsening HF symptoms. Failure to monitor and respond to HF symptoms may lead to unnecessary hospitalizations. Objective: This study aimed to (1) determine the feasibility of lung impedance measurements and a symptom diary to monitor HF symptoms daily at home for 30 days following hospital discharge and (2) determine daily changes in HF symptoms of pulmonary edema, lung impedance measurements, and if self-care behavior improves over time when patients use these self-care monitoring tools. Methods: This study used a prospective longitudinal design including patients from cardiology wards in 2 university hospitals—one in Norway and one in Lithuania. Data on HF symptoms and pulmonary edema were collected from 10 participants (mean age 64.5 years; 90% (9/10) male) with severe HF (New York Heart Association classes III and IV) who were discharged home after being hospitalized for an HF condition. HF symptoms were self-reported using the Memorial Symptom Assessment Scale for Heart Failure. Pulmonary edema was measured by participants using a noninvasive lung impedance monitor, the CardioSet Edema Guard Monitor. Informal caregivers aided the participants with the noninvasive measurements. Results: The prevalence and burden of shortness of breath varied from participants experiencing them daily to never, whereas lung impedance measurements varied for individual participants and the group participants, as a whole. Self-care behavior score improved significantly (P=.007) from a median of 56 (IQR range 22-75) at discharge to a median of 81 (IQR range 72-98) 30 days later. Conclusions: Noninvasive measurement of lung impedance daily and the use of a symptom diary were feasible at home for 30 days in HF patients. Self-care behavior significantly improved after 30 days of using a symptom diary and measuring lung impedance at home. Further research is needed to determine if daily self-care monitoring of HF signs and symptoms, combined with daily lung impedance measurements, may reduce hospital readmissions. %M 31909717 %R 10.2196/15445 %U https://www.jmir.org/2020/1/e15445 %U https://doi.org/10.2196/15445 %U http://www.ncbi.nlm.nih.gov/pubmed/31909717 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 1 %P e13346 %T Efficacy of a Self-Help Web-Based Recovery Training in Improving Sleep in Workers: Randomized Controlled Trial in the General Working Population %A Behrendt,Doerte %A Ebert,David Daniel %A Spiegelhalder,Kai %A Lehr,Dirk %+ Department of Health Psychology and Applied Biological Psychology, Institute of Psychology, Leuphana University of Lueneburg, Universitätsallee 1, Lueneburg, 21335, Germany, 49 41316772374, behrendt@leuphana.de %K occupational health %K e-mental-health %K insomnia %K Web-based, cognitive behavioral therapy %K mediators %D 2020 %7 7.1.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Sleep complaints are among the most prevalent health concerns, especially among workers, which may lead to adverse effects on health and work. Internet-delivered cognitive behavioral therapy for insomnia (iCBT-I) offers the opportunity to deliver effective solutions on a large scale. The efficacy of iCBT-I for clinical samples has been demonstrated in recent meta-analyses, and there is evidence that iCBT-I is effective in the working population with severe sleep complaints. However, to date, there is limited evidence from randomized controlled trials that iCBT-I could also be an effective tool for universal prevention among the general working population regardless of symptom severity. Although increasing evidence suggests that negatively toned cognitive activity may be a key factor for the development and maintenance of insomnia, little is known about how iCBT-I improves sleep by reducing presleep cognitive activity. Objective: This study aimed to examine the efficacy of a self-help internet-delivered recovery training, based on principles of iCBT-I tailored to the work-life domain, among the general working population. General and work-related cognitive activities were investigated as potential mediators of the intervention’s effect. Methods: A sample of 177 workers were randomized to receive either the iCBT-I (n=88) or controls (n=89). The intervention is a Web-based training consisting of six 1-week modules. As the training was self-help, participants received nothing but technical support via email. Web-based self-report assessments were scheduled at baseline, at 8 weeks, and at 6 months following randomization. The primary outcome was insomnia severity. Secondary outcomes included measures of mental health and work-related health and cognitive activity. In an exploratory analysis, general and work-related cognitive activities, measured as worry and work-related rumination, were investigated as mediators. Results: Analysis of the linear mixed effects model showed that, relative to controls, participants who received iCBT-I reported significantly lower insomnia severity scores at postintervention (between-group mean difference −4.36; 95% CI −5.59 to − 3.03; Cohen d=0.97) and at 6-month follow-up (between-group difference: −3.64; 95% CI −4.89 to −2.39; Cohen d=0.86). The overall test of group-by-time interaction was significant (P<.001). Significant differences, with small-to-large effect sizes, were also detected for cognitive activity and for mental and work-related health, but not for absenteeism. Mediation analysis demonstrated that work-related rumination (indirect effect: a1b1=−0.80; SE=0.34; 95% boot CI −1.59 to −0.25) and worry (indirect effect: a2b2=−0.37; SE=0.19; 95% boot CI −0.85 to −0.09) mediate the intervention’s effect on sleep. Conclusions: A self-help Web-based recovery training, grounded in the principles of iCBT-I, can be effective in the general working population, both short and long term. Work-related rumination may be a particularly crucial mediator of the intervention’s effect, suggesting that tailoring interventions to the workplace, including components to reduce the work-related cognitive activity, might be important when designing recovery interventions for workers. Trial Registration: German Clinical Trials Register DRKS00007142; https://www.drks.de/DRKS00007142 %M 31909725 %R 10.2196/13346 %U https://www.jmir.org/2020/1/e13346 %U https://doi.org/10.2196/13346 %U http://www.ncbi.nlm.nih.gov/pubmed/31909725 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 1 %P e15592 %T A Web- and Mobile App–Based Mental Health Promotion Intervention Comparing Email, Short Message Service, and Videoconferencing Support for a Healthy Cohort: Randomized Comparative Study %A Renfrew,Melanie Elise %A Morton,Darren Peter %A Morton,Jason Kyle %A Hinze,Jason Scott %A Beamish,Peter James %A Przybylko,Geraldine %A Craig,Bevan Adrian %+ Lifestyle and Health Research Centre, Avondale University College, 582 Freemans Drive, Cooranbong, New South Wales, , Australia, 61 405445151, melrenfrew@gmail.com %K guidance %K health promotion %K eHealth %K short message service %K videoconferencing %D 2020 %7 6.1.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: The rapid increase in mental health disorders has prompted a call for greater focus on mental health promotion and primary prevention. Web- and mobile app–based interventions present a scalable opportunity. Little is known about the influence of human support on the outcomes of these interventions. Objective: This study aimed to compare the influence of 3 modes of human support on the outcomes (ie, mental health, vitality, depression, anxiety, stress, life satisfaction, and flourishing) of a 10-week, Web- and mobile app–based, lifestyle-focused mental health promotion intervention among a healthy adult cohort. Methods: Participants were recruited voluntarily using a combination of online and offline advertising. They were randomized, unblinded into 3 groups differentiated by human support mode: Group 1 (n=201): standard—fully automated emails (S); Group 2 (n=202): standard plus personalized SMS (S+pSMS); and Group 3 (n=202): standard plus weekly videoconferencing support (S+VCS), hosted by 1 trained facilitator. Participants accessed the intervention, including the questionnaire, on a Web-based learning management system or through a mobile app. The questionnaire, administered at pre- and postintervention, contained self-reported measures of mental well-being, including the “mental health” and “vitality” subscales from the Short Form Health Survey-36, Depression Anxiety and Stress Scale-21, Diener Satisfaction With Life Scale (SWLS), and Diener Flourishing Scale. Results: Of 605 potential participants, 458 (S: n=157, S+pSMS: n=163, and S+VCS: n=138) entered the study by completing registration and the preintervention questionnaire. At post intervention, 320 out of 458 participants (69.9%; S: n=103, S+pSMS: n=114, and S+VCS: n=103) completed the questionnaire. Significant within-group improvements were recorded from pre- to postintervention in all groups and in every outcome measure (P≤.001). No significant between-group differences were observed for outcomes in any measure: mental health (P=.77), vitality (P=.65), depression (P=.93), anxiety (P=.25), stress (P.57), SWLS (P=.65), and Flourishing Scale (P=.99). Adherence was not significantly different between groups for mean videos watched (P=.42) and practical activity engagement (P=.71). Participation in videoconference support sessions (VCSSs) was low; 37 out of 103 (35.9%) participants did not attend any VCSSs, and only 19 out of 103 (18.4%) attended 7 or more out of 10 sessions. Stratification within the S+VCS group revealed that those who attended 7 or more VCSSs experienced significantly greater improvements in the domains of mental health (P=.006; d=0.71), vitality (P=.005; d=0.73), depression (P=.04; d=0.54), and life satisfaction (P=.046; d=0.50) compared with participants who attended less than 7. Conclusions: A Web- and mobile app–based mental health promotion intervention enhanced domains of mental well-being among a healthy cohort, irrespective of human support. Low attendance at VCSSs hindered the ability to make meaningful between-group comparisons. Supplementing the intervention with VCSSs might improve outcomes when attendance is optimized. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): 12619001009101; http://www.anzctr.org.au/ACTRN12619001009101.aspx %M 31904578 %R 10.2196/15592 %U https://www.jmir.org/2020/1/e15592 %U https://doi.org/10.2196/15592 %U http://www.ncbi.nlm.nih.gov/pubmed/31904578 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 1 %P e15337 %T Usability Evaluations of Mobile Mental Health Technologies: Systematic Review %A Inal,Yavuz %A Wake,Jo Dugstad %A Guribye,Frode %A Nordgreen,Tine %+ Department of Information Science and Media Studies, University of Bergen, Fosswinckels Gate 6, Bergen, 5020, Norway, 47 41301855, yavuz.inal@uib.no %K systematic review %K mobile %K mHealth %K mental health %K usability evaluation %D 2020 %7 6.1.2020 %9 Review %J J Med Internet Res %G English %X Background: Many mobile health (mHealth) apps for mental health have been made available in recent years. Although there is reason to be optimistic about their effect on improving health and increasing access to care, there is a call for more knowledge concerning how mHealth apps are used in practice. Objective: This study aimed to review the literature on how usability is being addressed and measured in mHealth interventions for mental health problems. Methods: We conducted a systematic literature review through a search for peer-reviewed studies published between 2001 and 2018 in the following electronic databases: EMBASE, CINAHL, PsycINFO, PubMed, and Web of Science. Two reviewers independently assessed all abstracts against the inclusion and exclusion criteria, following the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. Results: A total of 299 studies were initially identified based on the inclusion keywords. Following a review of the title, abstract, and full text, 42 studies were found that fulfilled the criteria, most of which evaluated usability with patients (n=29) and health care providers (n=11) as opposed to healthy users (n=8) and were directed at a wide variety of mental health problems (n=24). Half of the studies set out to evaluate usability (n=21), and the remainder focused on feasibility (n=10) or acceptability (n=10). Regarding the maturity of the evaluated systems, most were either prototypes or previously tested versions of the technology, and the studies included few accounts of sketching and participatory design processes. The most common reason referred to for developing mobile mental health apps was the availability of mobile devices to users, their popularity, and how people in general became accustomed to using them for various purposes. Conclusions: This study provides a detailed account of how evidence of usability of mHealth apps is gathered in the form of usability evaluations from the perspective of computer science and human-computer interaction, including how users feature in the evaluation, how the study objectives and outcomes are stated, which research methods and techniques are used, and what the notion of mobility features is for mHealth apps. Most studies described their methods as trials, gathered data from a small sample size, and carried out a summative evaluation using a single questionnaire, which indicates that usability evaluation was not the main focus. As many studies described using an adapted version of a standard usability questionnaire, there may be a need for developing a standardized mHealth usability questionnaire. %M 31904579 %R 10.2196/15337 %U https://www.jmir.org/2020/1/e15337 %U https://doi.org/10.2196/15337 %U http://www.ncbi.nlm.nih.gov/pubmed/31904579 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 12 %P e15924 %T Exploring the Views of Osteogenesis Imperfecta Caregivers on Internet-Based Technologies: Qualitative Descriptive Study %A Castro,Aimee R %A Chougui,Khadidja %A Bilodeau,Claudette %A Tsimicalis,Argerie %+ Shriners Hospitals for Children-Canada, 1003 Decarie Blvd, Montreal, QC, H4A 0A9, Canada, 1 (514) 3988142, argerie.tsimicalis@mcgill.ca %K smartphone %K caregivers %K pediatrics %K rare diseases %K telemedicine %K quality improvement %K social media %K chronic disease %K osteogenesis imperfecta %D 2019 %7 18.12.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Osteogenesis imperfecta (OI) is a rare genetic condition that can lead to frequent debilitating bone fractures. Family caregivers of children with OI face unique challenges in providing care, which may include limited access to information about the condition, feelings of distress, and experiences of social isolation. Internet-based technologies (IBTs) have been useful for supporting other types of caregivers. However, the views of OI caregivers on IBTs have not been explored. Objective: This study aimed to explore the views of OI caregivers on the uses of IBTs to support them in caring for their children with OI. Methods: A qualitative descriptive study was conducted. Caregivers of children with OI were recruited at a pediatric hospital in Montreal, Canada. Interviews were used to explore each caregiver’s views on the applicability of IBTs in supporting their caregiving needs. The interviews were transcribed verbatim and thematically analyzed. Results: A total of 18 caregivers participated. The caregivers shared that IBTs were useful for facilitating the following activities: daily activities of caregiving (such as providing physical care, supporting relationships, supporting self-care and hope, and managing the logistics of caregiving), OI medical information seeking, and OI social networking. However, they also revealed concerns about the health consequences of IBT use and the quality of IBT content. Concerns regarding IBTs varied somewhat with caregivers’ geographies. Caregivers offered suggestions and strategies for how IBTs can be optimized for caregiving. Conclusions: Family caregivers of children with OI face unique challenges in providing care, which may include lacking access to information about the rare condition and feeling socially isolated. OI caregivers use IBTs to overcome some of these challenges and to support their specific caregiving needs. These findings contribute to the paucity of knowledge by offering varied IBT strategies to support caregiving activities, which may be beneficial for other caregivers. Participants’ suggestions for IBT services can inform the development of new resources for OI caregivers and potentially for other caregivers of children living with rare conditions. %M 31850851 %R 10.2196/15924 %U http://www.jmir.org/2019/12/e15924/ %U https://doi.org/10.2196/15924 %U http://www.ncbi.nlm.nih.gov/pubmed/31850851 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 12 %P e14985 %T Understanding Drivers of Resistance Toward Implementation of Web-Based Self-Management Tools in Routine Cancer Care Among Oncology Nurses: Cross-Sectional Survey Study %A de Wit,Matthijs %A Kleijnen,Mirella %A Lissenberg-Witte,Birgit %A van Uden-Kraan,Cornelia %A Millet,Kobe %A Frambach,Ruud %A Verdonck-de Leeuw,Irma %+ Vrije Universiteit Amsterdam, Department of Clinical, Neuro- and Developmental Psychology, Van der Boechorstraat 7, Amsterdam, 1081 BT, Netherlands, 31 204440988, im.verdonck@vumc.nl %K psycho-oncology %K health-related quality of life %K self-management %K eHealth %K implementation science %K resistance to innovations %D 2019 %7 17.12.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Supporting patients to engage in (Web-based) self-management tools is increasingly gaining importance, but the engagement of health care professionals is lagging behind. This can partly be explained by resistance among health care professionals. Objective: The aim of this study was to investigate drivers of resistance among oncology nurses toward Web-based self-management tools in cancer care. Methods: Drawing from previous research, combining clinical and marketing perspectives, and several variables and instruments, we developed the Resistance to Innovation model (RTI-model). The RTI-model distinguishes between passive and active resistance, which can be enhanced or reduced by functional drivers (incompatibility, complexity, lack of value, and risk) and psychological drivers (role ambiguity, social pressure from the institute, peers, and patients). Both types of drivers can be moderated by staff-, organization-, patient-, and environment-related factors. We executed a survey covering all components of the RTI-model on a cross-sectional sample of nurses working in oncology in the Netherlands. Structural equation modeling was used to test the full model, using a hierarchical approach. In total, 2500 nurses were approached, out of which 285 (11.40%) nurses responded. Results: The goodness of fit statistic of the uncorrected base model of the RTI-model (n=239) was acceptable (χ21=9.2; Comparative Fit Index=0.95; Tucker Lewis index=0.21; Root Mean Square Error of Approximation=0.19; Standardized Root Mean Square=0.016). In line with the RTI-model, we found that both passive and active resistance among oncology nurses toward (Web-based) self-management tools were driven by both functional and psychological drivers. Passive resistance toward Web-based self-management tools was enhanced by complexity, lack of value, and role ambiguity, and it was reduced by institutional social pressure. Active resistance was enhanced by complexity, lack of value, and social pressure from peers, and it was reduced by social pressure from the institute and patients. In contrast to what we expected, incompatibility with current routines was not a significant driver of either passive or active resistance. This study further showed that these drivers of resistance were moderated by expertise (P=.03), managerial support (P=.004), and influence from external stakeholders (government; P=.04). Conclusions: Both passive and active resistance in oncology nurses toward Web-based self-management tools for patients with cancer are driven by functional and psychological drivers, which may be more or less strong, depending on expertise, managerial support, and governmental influence. %M 31845900 %R 10.2196/14985 %U http://www.jmir.org/2019/12/e14985/ %U https://doi.org/10.2196/14985 %U http://www.ncbi.nlm.nih.gov/pubmed/31845900 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 12 %P e15836 %T A Web-Based Self-Titration Program to Control Blood Pressure in Patients With Primary Hypertension: Randomized Controlled Trial %A Kao,Chi-Wen %A Chen,Ting-Yu %A Cheng,Shu-Meng %A Lin,Wei-Shiang %A Chang,Yue-Cune %+ Department of Nursing, Tri-Service General Hospital, No 325, Sec 2, Chenggong Rd, Taipei, 114, Taiwan, 886 2 87923311 ext 17359, chiwenkao@ndmctsgh.edu.tw %K Web-based %K self-titration %K blood pressure %K hypertension %K health-related quality of life %D 2019 %7 5.12.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Hypertension is a major cause of mortality in cardiac, vascular, and renal disease. Effective control of elevated blood pressure has been shown to reduce target organ damage. A Web-based self-titration program may empower patients to control their own disease, share decisions about antihypertensive dose titration, and improve self-management, ultimately improving health-related quality of life. Objective: Our primary aim was to evaluate the effects of a Web-based self-titration program for improving blood pressure control in patients with primary hypertension. Our secondary aim was to evaluate the effects of that program on improving health-related quality of life. Methods: This was a parallel-group, double-blind, randomized controlled trial with assessments at baseline, 3 months, and 6 months. We included patients with primary hypertension (blood pressure>130/80 mm Hg) from a cardiology outpatient department in northern Taiwan and divided them randomly into intervention and control groups. The intervention group received the Web-based self-titration program, while the control group received usual care. The random allocation was concealed from participants and outcome evaluators. Health-related quality of life was measured by the EuroQol five-dimension self-report questionnaire. We used generalized estimating equations to evaluate the effects of the intervention. Results: We included 222 patients and divided them equally into intervention (n=111) and control (n=111) groups. Patients receiving the Web-based self-titration program showed significantly greater improvement in the systolic and diastolic blood pressure control than those who did not receive this program, at 3 months (–21.4 mm Hg and –5.4 mm Hg, respectively; P<.001) and 6 months (–27.8 mm Hg and –9.7 mm Hg, respectively; P<.001). Compared with the control group, the intervention group showed a significant decrease in the overall defined daily dose at both 3 (–0.202, P=.003) and 6 (–0.236, P=.001) months. Finally, health-related quality of life improved significantly in the intervention group compared with the control group at both 3 and 6 months (both, P<.001). Conclusions: A Web-based self-titration program can provide immediate feedback to patients about how to control their blood pressure and manage their disease at home. This program not only decreases mean blood pressure but also increases health-related quality of life in patients with primary hypertension. Trial Registration: ClinicalTrials.gov NCT03470974; https://clinicaltrials.gov/ct2/show/NCT03470974 %M 31804186 %R 10.2196/15836 %U https://www.jmir.org/2019/12/e15836 %U https://doi.org/10.2196/15836 %U http://www.ncbi.nlm.nih.gov/pubmed/31804186 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 2 %N 2 %P e14518 %T A Pragmatic Internet Intervention to Promote Positive Parenting and School Readiness in Early Childhood: Initial Evidence of Program Use and Satisfaction %A McGoron,Lucy %A Ratner,Hilary Horn %A Knoff,Kathryn AG %A Hvizdos,Erica %A Ondersma,Steven J %+ Wayne State University, The Merrill Palmer Skillman Institute for Child and Family Development, 71 E Ferry St, Detroit, MI, 48202, United States, 1 3136642553, Lucy.K.McGoron@wayne.edu %K child rearing %K child development %D 2019 %7 29.11.2019 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Internet-based parenting programs have the potential to connect families to research-informed materials to promote positive child development. However, such programs can only succeed to the extent that the intended population engages with them. Objective: This study aimed to evaluate engagement in the 5-a-Day Parenting program, a technology-based program designed with low-income families in mind, to promote daily use of 5 specific parenting activities conducive to children’s school readiness. Following earlier pilot data, the program was enhanced with an initial motivational e-intervention and tailored text messages designed to promote engagement. Methods: Parents were recruited from local childcare centers and through a participant registry. We examined rates of receipt of program text messages and use of video-based content on the program website, 3 factors that may affect website use, and satisfaction with key program elements. Results: A total of 360 parents of young children learned about the study and had the opportunity to use the 5-a-Day Parenting website. Of these, 94 parents participated in the study, and 33% (31/94) accessed the video-based content on the website at least once. No association was found between website use and program recruitment approach, program-affiliation message, sociocontextual risk, and baseline use of the five parenting activities. Satisfaction with text messages and video-based content was high. Conclusions: For some parents, technology-based programs appear useful; however, engagement could still be enhanced. Additional research should seek innovative strategies for promoting engagement in Web-based parenting programs. %M 31782739 %R 10.2196/14518 %U http://pediatrics.jmir.org/2019/2/e14518/ %U https://doi.org/10.2196/14518 %U http://www.ncbi.nlm.nih.gov/pubmed/31782739 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 11 %P e14343 %T Effects of Mobile Health App Interventions on Sedentary Time, Physical Activity, and Fitness in Older Adults: Systematic Review and Meta-Analysis %A Yerrakalva,Dharani %A Yerrakalva,Dhrupadh %A Hajna,Samantha %A Griffin,Simon %+ Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Institute of Public Health, Cambridge, , United Kingdom, 44 1223 330300, dharaniyerrakalva@googlemail.com %K sedentary behavior %K physical activity %K physical fitness %K aged %K mHealth %K mobile apps %D 2019 %7 28.11.2019 %9 Review %J J Med Internet Res %G English %X Background: High sedentary time, low physical activity (PA), and low physical fitness place older adults at increased risk of chronic diseases, functional decline, and premature mortality. Mobile health (mHealth) apps, apps that run on mobile platforms, may help promote active living. Objective: We aimed to quantify the effect of mHealth app interventions on sedentary time, PA, and fitness in older adults. Methods: We systematically searched five electronic databases for trials investigating the effects of mHealth app interventions on sedentary time, PA, and fitness among community-dwelling older adults aged 55 years and older. We calculated pooled standardized mean differences (SMDs) in these outcomes between the intervention and control groups after the intervention period. We performed a Cochrane risk of bias assessment and Grading of Recommendations, Assessment, Development, and Evaluation certainty assessment. Results: Overall, six trials (486 participants, 66.7% [324/486] women; age mean 68 [SD 6] years) were included (five of these trials were included in the meta-analysis). mHealth app interventions may be associated with decreases in sedentary time (SMD=−0.49; 95% CI −1.02 to 0.03), increases in PA (506 steps/day; 95% CI −80 to 1092), and increases in fitness (SMD=0.31; 95% CI −0.09 to 0.70) in trials of 3 months or shorter and with increases in PA (753 steps/day; 95% CI −147 to 1652) in trials of 6 months or longer. Risk of bias was low for all but one study. The quality of evidence was moderate for PA and sedentary time and low for fitness. Conclusions: mHealth app interventions have the potential to promote changes in sedentary time and PA over the short term, but the results did not achieve statistical significance, possibly because studies were underpowered by small participant numbers. We highlight a need for larger trials with longer follow-up to clarify if apps deliver sustained clinically important effects. %M 31778121 %R 10.2196/14343 %U http://www.jmir.org/2019/11/e14343/ %U https://doi.org/10.2196/14343 %U http://www.ncbi.nlm.nih.gov/pubmed/31778121 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 3 %N 4 %P e13577 %T An Electronic Health Tool to Prepare for the First Orthopedic Consultation: Use and Usability Study %A Claassen,Aniek A O M %A Vliet Vlieland,Thea P M %A Busch,Vincent J J F %A Schers,Henk J %A van den Hoogen,Frank H J %A van den Ende,Cornelia H M %+ Department of Rheumatology, Sint Maartenskliniek, PO Box 9011, Nijmegen, 9700 GM, Netherlands, 31 243659145, a.claassen@maartenskliniek.nl %K osteoarthritis %K patient education %K consultation %K eHealth %K smartphone %K use %D 2019 %7 28.11.2019 %9 Original Paper %J JMIR Form Res %G English %X Background: The use of electronic health (eHealth) technology to prepare patients with hip or knee osteoarthritis (OA) for their first orthopedic consultation seems promising. Exploration of the use and usability of an educational eHealth tool may highlight potential modifications that could increase patient engagement and effectiveness. Objective: This study aimed to (1) identify the use and usability of a stand-alone educational eHealth tool for patients with suspected hip or knee OA, (2) explore whether the recorded questions in the eHealth tool were in line with an existing widely used question prompt list, and (3) investigate whether user characteristics are related to use and usability. Methods: We used data from 144 participants in the intervention group of a randomized controlled trial, who were asked to use the educational eHealth tool to prepare for their upcoming first orthopedic consultation. We defined users and nonusers based on whether they had opened the tool at least once. Users were characterized as active or superficial depending on the extent of their use of the tool. The recorded questions for the consultation preparation were categorized into themes fitting 3 predefined questions or in a remaining category. Usability was measured using the System Usability Scale (SUS, 0-100). Data were collected including the patient demographic and clinical characteristics, knowledge of OA, and internet and smartphone usage in daily life. The characteristics associated with users and nonusers were analyzed using a multivariable logistic regression analysis. Results: A total of 116/144 (80.6%) participants used the educational eHealth tool, of whom 87/116 (75.0%) were active users. Of the three components of the tool (information, my consultation, and medication), medication was the least used (34%). On the basis of recorded questions of the users, the fourth predefined question could be proposed. The mean (SD) SUS score was 64.8 (16.0). No difference was found between the SUS scores of superficial and active users (mean difference 0.04, 95% CI −7.69 to 7.77). Participants with a higher baseline knowledge of OA (odds ratio [OR] 1.2, 95% CI 1.0 to 1.4) and who used the internet less frequently in their daily life (OR 0.6, 95% CI 0.5 to 0.9) were more likely to use the educational eHealth tool. We found no differences between the demographics and clinical characteristics of the superficial and active users. Conclusions: Based on the results of this study, it can be concluded that the use of an educational eHealth tool to prepare patients with hip and knee OA for the first orthopedic consultation is feasible. Our results suggest some improvements that should be made to the content of the tool to improve its usability. No clear practical implications were found to support the implementation of the educational eHealth tool in specific subgroups. Trial Registration: Netherlands Trial Register NTR6262; https://www.trialregister.nl/trial/6262 %M 31778119 %R 10.2196/13577 %U http://formative.jmir.org/2019/4/e13577/ %U https://doi.org/10.2196/13577 %U http://www.ncbi.nlm.nih.gov/pubmed/31778119 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 11 %P e12497 %T Relating Instructional Design Components to the Effectiveness of Internet-Based Mindfulness Interventions: A Critical Interpretive Synthesis %A Lippmann,Marie %A Laudel,Helena %A Heinzle,Marlene %A Narciss,Susanne %+ Department of Psychology, California State University, 400 West First Street, Chico, CA, 95929, United States, 1 530 898 5281, mlippmann@csuchico.edu %K mindfulness %K internet %K instructional design %D 2019 %7 27.11.2019 %9 Review %J J Med Internet Res %G English %X Background: Internet-based mindfulness interventions are a promising approach to address challenges in the dissemination and implementation of mindfulness interventions, but it is unclear how the instructional design components of such interventions are associated with intervention effectiveness. Objective: The objective of this study was to identify the instructional design components of the internet-based mindfulness interventions and provide a framework for the classification of those components relative to the intervention effectiveness. Methods: The critical interpretive synthesis method was applied. In phase 1, a strategic literature review was conducted to generate hypotheses for the relationship between the effectiveness of internet-based mindfulness interventions and the instructional design components of those interventions. In phase 2, the literature review was extended to systematically explore and revise the hypotheses from phase 1. Results: A total of 18 studies were identified in phase 1; 14 additional studies were identified in phase 2. Of the 32 internet-based mindfulness interventions, 18 were classified as more effective, 11 as less effective, and only 3 as ineffective. The effectiveness of the interventions increased with the level of support provided by the instructional design components. The main difference between effective and ineffective interventions was the presence of just-in-time information in the form of reminders. More effective interventions included more supportive information (scores: 1.91 in phases 1 and 2) than less effective interventions (scores: 1.00 in phase 1 and 1.80 in phase 2), more part-task practice (scores: 1.18 in phase 1 and 1.60 in phase 2) than less effective interventions (scores: 0.33 in phase 1 and 1.40 in phase 2), and provided more just-in-time information (scores: 1.35 in phase 1 and 1.67 in phase 2) than less effective interventions (scores: 0.83 in phase 1 and 1.60 in phase 2). The average duration of more effective, less effective, and ineffective interventions differed for the studies of phase 1, with more effective interventions taking up more time (7.45 weeks) than less effective (4.58 weeks) or ineffective interventions (3 weeks). However, this difference did not extend to the studies of phase 2, with comparable average durations of effective (5.86 weeks), less effective (5.6 weeks), and ineffective (7 weeks) interventions. Conclusions: Our results suggest that to be effective, internet-based mindfulness interventions must contain 4 instructional design components: formal learning tasks, supportive information, part-task practice, and just-in-time information. The effectiveness of the interventions increases with the level of support provided by each of these instructional design components. %M 31774413 %R 10.2196/12497 %U http://www.jmir.org/2019/11/e12497/ %U https://doi.org/10.2196/12497 %U http://www.ncbi.nlm.nih.gov/pubmed/31774413 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 11 %P e14729 %T Mechanisms and Effects of a WeChat-Based Intervention on Suicide Among People Living With HIV and Depression: Path Model Analysis of a Randomized Controlled Trial %A Li,Yiran %A Guo,Yan %A Hong,Y Alicia %A Zhu,Mengting %A Zeng,Chengbo %A Qiao,Jiaying %A Xu,Zhimeng %A Zhang,Hanxi %A Zeng,Yu %A Cai,Weiping %A Li,Linghua %A Liu,Cong %+ Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, #74 Zhongshan 2nd Road, Guangzhou, , China, 86 020 87334202, guoy8@mail.sysu.edu.cn %K HIV %K mHealth %K depression %K suicide %D 2019 %7 27.11.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: People living with HIV and depression have high rates of suicide. Studies of mobile health (mHealth) interventions have shown feasibility, acceptability, and efficacy in improving mental health in people living with HIV and depression. However, few studies have examined the mechanisms and effects of mHealth interventions on suicide. Objective: This study was designed to examine the mechanisms and effects of a WeChat-based intervention, Run4Love, on suicide among people living with HIV and depression in China, while considering perceived stress and depressive symptoms as mediators. Methods: A sample of 300 People living with HIV and depression was recruited from the outpatient clinic of a large HIV or AIDS treatment hospital and was randomized to the Run4Love group or a control group. Data were collected at baseline, 3-, 6-, and 9-month follow-ups. Path analysis modeling, with longitudinal data, was used in data analyses. Results: The Run4Love mHealth intervention had a direct effect on reducing suicide rate at the 6-month follow-up (beta=−.18, P=.02) and indirect effect through reducing perceived stress and depressive symptoms at the 3-month follow-up (beta=−.09, P=.001). A partial mediating effect between perceived stress and depressive symptoms accounted for 33% (–0.09/–0.27) of the total effect. Conclusions: Through path analyses, we understood the mechanisms and effects of an mHealth intervention on suicide prevention. The findings underscored the importance of stress reduction and depression treatment in such a program. We call for more effective suicide prevention, especially mHealth interventions targeting the vulnerable population of people living with HIV and depression. Trial Registration: Chinese Clinical Trial Registry ChiCTR-IPR-17012606; http://www.chictr.org.cn/showprojen.aspx?proj=21019 %M 31774411 %R 10.2196/14729 %U https://www.jmir.org/2019/11/e14729 %U https://doi.org/10.2196/14729 %U http://www.ncbi.nlm.nih.gov/pubmed/31774411 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 11 %P e13579 %T Mobile and Web-Based Apps That Support Self-Management and Transition in Young People With Chronic Illness: Systematic Review %A Virella Pérez,Yisselle Ilene %A Medlow,Sharon %A Ho,Jane %A Steinbeck,Katharine %+ The Children’s Hospital at Westmead, Academic Department of Adolescent Medicine, Corner Hawkesbury Road and Hainsworth Street, Locked Bag 4001, Westmead, New South Wales, 2145, Australia, 61 2 9845 2507, yisselle.virella@gmail.com %K adolescent %K mobile app %K Web-based app %K chronic illness %K self-management %K transition to adult care %D 2019 %7 20.11.2019 %9 Review %J J Med Internet Res %G English %X Background: More adolescents with chronic physical illness are living into adulthood, and they require the development of proficient self-management skills to maintain optimal physical health as they transition into adult care services. It is often during this vulnerable transition period that deterioration in illness control is seen as a result of inadequate self-management skills and understanding of their chronic illness. Mobile technology has been proposed as an innovative opportunity to assist in improving the management of chronic conditions as young people transition to adult care services. Over the past 5 years, there has been a significant increase in research into the use of health-related apps. Objective: This study aimed to evaluate the utility and effectiveness of mobile and Web-based health apps that support self-management and transition in young people with chronic physical health illnesses. Methods: We conducted a comprehensive review of the literature in 5 bibliographic databases, using key search terms, considering only articles published from 2013, as we were extending the data from 2 previous systematic reviews. Abstracts were screened for possible inclusion by 2 reviewers. Data extraction and quality assessment tools were used for the evaluation of included studies. Results: A total of 1737 records were identified from the combined electronic searches, and 854 records were removed as duplicates. A total of 68 full articles were further assessed for eligibility, and 6 articles met our review criteria: 3 pilot studies, 2 randomized controlled trials, and 1 prospective cohort study. Publication years ranged from 2015 to 2018. The apps reported were targeted at type 1 diabetes mellitus, epilepsy, asthma, beta thalassemia major, and sickle cell disease, with a combined sample size of 336. A total of 4 studies included in this review reported being effective in increasing knowledge of the targeted condition and increasing therapy adherence, including increased medication adherence. A total of 2 manuscripts only mentioned the word transition. Participant’s satisfaction was reported for all studies. Heterogeneity of the studies prevented meta-analysis. Conclusions: There remain limited data on the effectiveness and use of mobile and Web-based apps, which might facilitate the transition of adolescents with chronic illnesses from pediatric to adult health care services. This systematic review provides an updated overview of available apps for adolescents with chronic illnesses. This systematic review has been unable to provide evidence for effectiveness of this approach, but it does provide insights into future study design, with reference to the development, evaluation, and efficacy of apps tailored for adolescents with chronic illnesses, including the involvement of adolescents in such designs. Trial Registration: PROSPERO CRD42018104611; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=104611 %M 31746773 %R 10.2196/13579 %U http://www.jmir.org/2019/11/e13579/ %U https://doi.org/10.2196/13579 %U http://www.ncbi.nlm.nih.gov/pubmed/31746773 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 11 %P e14754 %T Use of a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention in a Community Population of Adults With Depression Symptoms: Randomized Controlled Trial %A Schure,Mark B %A Lindow,Janet C %A Greist,John H %A Nakonezny,Paul A %A Bailey,Sandra J %A Bryan,William L %A Byerly,Matthew J %+ Department of Health & Human Development, Montana State University, 305 Herrick Hall, Bozeman, MT, United States, 1 406 994 3248, mark.schure@montana.edu %K internet-based cognitive behavior therapy %K iCBT %K depression symptoms %K rural populations %K RCT %K randomized controlled trial %K CBT %D 2019 %7 18.11.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Although internet-based cognitive behavior therapy (iCBT) interventions can reduce depression symptoms, large differences in their effectiveness exist. Objective: The aim of this study was to evaluate the effectiveness of an iCBT intervention called Thrive, which was designed to enhance engagement when delivered as a fully automated, stand-alone intervention to a rural community population of adults with depression symptoms. Methods: Using no diagnostic or treatment exclusions, 343 adults with depression symptoms were recruited from communities using an open-access website and randomized 1:1 to the Thrive intervention group or the control group. Using self-reports, participants were evaluated at baseline and 4 and 8 weeks for the primary outcome of depression symptom severity and secondary outcome measures of anxiety symptoms, work and social adjustment, psychological resilience, and suicidal ideation. Results: Over the 8-week follow-up period, the intervention group (n=181) had significantly lower depression symptom severity than the control group (n=162; P<.001), with a moderate treatment effect size (d=0.63). Moderate to near-moderate effect sizes favoring the intervention group were observed for anxiety symptoms (P<.001; d=0.47), work/social functioning (P<.001; d=0.39), and resilience (P<.001; d=0.55). Although not significant, the intervention group was 45% less likely than the control group to experience increased suicidal ideation (odds ratio 0.55). Conclusions: These findings suggest that the Thrive intervention was effective in reducing depression and anxiety symptom severity and improving functioning and resilience among a mostly rural community population of US adults. The effect sizes associated with Thrive were generally larger than those of other iCBT interventions delivered as a fully automated, stand-alone intervention. Trial Registration: ClinicalTrials.gov NCT03244878; https://clinicaltrials.gov/ct2/show/NCT03244878 %M 31738173 %R 10.2196/14754 %U http://www.jmir.org/2019/11/e14754/ %U https://doi.org/10.2196/14754 %U http://www.ncbi.nlm.nih.gov/pubmed/31738173 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 3 %N 4 %P e13682 %T An Internet-Based Therapeutic Tool for American Indian/Alaska Native Adults With Posttraumatic Stress Disorder: User Testing and Developmental Feasibility Study %A Hiratsuka,Vanessa Y %A Moore,Laurie %A Avey,Jaedon P %A Dirks,Lisa G %A Beach,Barbara D %A Dillard,Denise A %A Novins,Douglas K %+ Research Department, Southcentral Foundation, 4085 Tudor Centre Drive, Anchorage, AK, 99508-5919, United States, 1 907 729 8627, vhiratsuka@scf.cc %K formative research %K posttraumatic stress disorder %K Web-based intervention %K Indians, North American %D 2019 %7 13.11.2019 %9 Original Paper %J JMIR Form Res %G English %X Background: Posttraumatic stress disorder (PTSD) is a major public health concern among American Indian and Alaska Native populations. Primary care clinics are often the first point of contact for American Indian and Alaska Natives seeking health care and are feasible locations for trauma-focused interventions. Objective: Web-based therapeutic interventions have the potential to reduce PTSD symptoms by offering psychoeducation and symptom self-management tools. We investigated the feasibility of a culturally adapted Web-based therapeutic intervention in two American Indian and Alaska Native–serving primary care sites. We developed and tested a self-guided Web-based therapeutic intervention aimed at improving knowledge and awareness of, and provision of guidance, support, and symptom-management for, PTSD symptoms. Methods: A community-based participatory research process was used to refine adaptations to the veteran’s administration’s PTSD Coach Online, to develop new content, and to guide and interpret the results of the feasibility pilot. This process resulted in a 16-guide intervention “Health is Our Tradition: Balance and Harmony after Trauma” website. The feasibility pilot included 24 American Indian and Alaska Natives aged 18 years and older who scored positive on a primary care PTSD screener. Enrolled participants completed a demographic questionnaire, an experience with technology questionnaire, and baseline behavioral health measures. Once measures were complete, research staff described weekly text messages, minimum study expectations for website use, and demonstrated how to use the website. Feasibility measures included self-reported website use, ratings of satisfaction and perceived effectiveness, and website metrics. Feasibility of obtaining measures for an effectiveness trial was also assessed to include behavioral health symptoms and service utilization through self-report instruments and electronic health record queries. Self-reported measures were collected at enrollment and at 6 and 12 weeks post enrollment. Electronic health records were collected from 12 months before study enrollment to 3 months following study enrollment. Changes between enrollment and follow-up were examined with paired t tests, analysis of variance or logistic regression, or the Wilcoxon signed rank test for nonnormally distributed data. Results: The culturally adapted website and associated text message reminders were perceived as satisfactory and effective by participants with no differences by age or gender. The majority of participants (86%, 19/24) reported use of the website at 6 weeks and nearly all (91%, 20/22) at 12 weeks. At 6 weeks, 55% (12/22) of participants reported using the website at the recommended intensity (at least three times weekly), dropping to 36% (8/22) at 12 weeks. Participant use of modules varied from 8% (2/24) to 100% (24/24), with guide completion rates being greater for guides that were only psychoeducational in nature compared with guides that were interactive. There were no significant changes in patterns of diagnoses, screening, medications, or service utilization during exposure to the website. Conclusions: “Health is Our Tradition: Balance and Harmony after Trauma” shows promise for an effectiveness pilot. %M 31719027 %R 10.2196/13682 %U http://formative.jmir.org/2019/4/e13682/ %U https://doi.org/10.2196/13682 %U http://www.ncbi.nlm.nih.gov/pubmed/31719027 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 11 %P e14419 %T Electronic Screening for Alcohol Use and Brief Intervention by Email for University Students: Reanalysis of Findings From a Randomized Controlled Trial Using a Bayesian Framework %A Bendtsen,Marcus %+ Department of Medical and Health Sciences, Linköping University, Linköping, 58183, Sweden, 46 13281000, marcus.bendtsen@liu.se %K Bayesian analysis %K telemedicine %K alcohol %K randomized controlled trial %D 2019 %7 7.11.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Almost a decade ago, Sweden became the first country to implement a national system enabling student health care centers across all universities to routinely administer (via email) an electronic alcohol screening and brief intervention to their students. The Alcohol email assessment and feedback study dismantling effectiveness for university students (AMADEUS-1) trial aimed to assess the effect of the student health care centers’ routine practices by exploiting the lack of any standard timing for the email invitation and by masking trial participation from students. The original analyses adopted the conventional null hypothesis framework, and the results were consistently in the expected direction. However, since for some tests the P values did not pass the conventional .05 threshold, some of the analyses were necessarily inconclusive. Objective: The outcomes of the AMADEUS-1 trial were derived from the first 3 items of the Alcohol Use Disorders Identification Test (AUDIT-C). The aim of this paper was to reanalyze the two primary outcomes of the AMADEUS-1 trial (AUDIT-C scores and prevalence of risky drinking), using the same models used in the original publication but applying a Bayesian inference framework and interpretation. Methods: The same regression models used in the original analysis were employed in this reanalysis (linear and logistic regression). Model parameters were given uniform priors. Markov chain Monte Carlo was used for Bayesian inference, and posterior probabilities were calculated for prespecified thresholds of interest. Results: Where the null hypothesis tests showed inconclusive results, the Bayesian analysis showed that offering an intervention at baseline was preferable compared to offering nothing. At follow-up, the probability of a lower AUDIT-C score among those who had been offered an intervention at baseline was greater than 95%, as was the case when comparing the prevalence of risky drinking. Conclusions: The Bayesian analysis allows for a more consistent perspective of the data collected in the trial, since dichotomization of evidence is not looked for at some arbitrary threshold. Results are presented that represent the data collected in the trial rather than trying to make conclusions about the existence of a population effect. Thus, policy makers can think about the value of keeping the national system without having to navigate the treacherous landscape of statistical significance. Trial Registration: ISRCTN Registry ISRCTN28328154; http://www.isrctn.com/ISRCTN28328154 %M 31697242 %R 10.2196/14419 %U https://www.jmir.org/2019/11/e14419 %U https://doi.org/10.2196/14419 %U http://www.ncbi.nlm.nih.gov/pubmed/31697242 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 11 %P e14269 %T A New Mental Health Mobile App for Well-Being and Stress Reduction in Working Women: Randomized Controlled Trial %A Coelhoso,Cássia Canha %A Tobo,Patricia Renovato %A Lacerda,Shirley Silva %A Lima,Alex Heitor %A Barrichello,Carla Regina Camara %A Amaro Jr,Edson %A Kozasa,Elisa Harumi %+ Hospital Israelita Albert Einstein, Av. Albert Einstein, 627/701 bloco A 2ºSS, Sao Paulo, 05601-901, Brazil, 55 11 99179 9721, ehkozasa@gmail.com %K stress, psychological %K mental health %K health promotion %K mobile applications %K mind-body therapies %K meditation %K behavioral symptoms %K behavioral medicine %K psychology %K women’s health %D 2019 %7 7.11.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Although the availability and use of mobile mental health apps has grown exponentially in recent years, little data are available regarding their efficacy. Objective: This study aimed to evaluate the effectiveness of an app developed to promote stress management and well-being among working women compared with a control app. Methods: Female employees at a private hospital were invited to participate in the study via mailing lists and intranet ads. A total of 653 individuals self-enrolled through the website. Eligible participants were randomized between control (n=240) and intervention (n=250) groups. The well-being mobile app provides an 8-week program with 4 classes per week (including a brief theoretical portion and a 15-min guided practice). The active control app also provided 4 assessments per week that encouraged participants to self-observe how they were feeling for 20 min. We also used the app to conduct Web-based questionnaires (10-item Perceived Stress Scale and 5-item World Health Organization Well-Being Index) and ask specific questions to assess subjective levels of stress and well-being at baseline (t1), midintervention (t4=4 weeks after t1) and postintervention (t8=8 weeks after t1). Both apps were fully automated without any human involvement. Outcomes from the control and intervention conditions at the 3 time points were analyzed using a repeated measures analysis of variance. Results: Among the randomized participants (n=490), 185 participants were excluded at the 4-week follow-up and another 79 at the 8-week follow-up because of noncompliance with the experimental protocol. Participants who did not complete t4 and t8 assessments were equally distributed between groups (t4: control group=34.6% [83/240] and intervention group=40.8% [102/250]; P=.16; t8: control group=29.9% [47/157] and intervention group=21.6% [32/148]; P=.10). Both groups showed a significant increase in general well-being as a function of time (F2,426=5.27; P=.006), but only the intervention group presented a significant increase in work-related well-being (F2,426=8.92; P<.001), as well as a significant reduction in work-related and overall stress (F2,426=5.50; P=.004 and F2,426=8.59; P<.001, respectively). Conclusions: The well-being mobile app was effective in reducing employee stress and improving well-being. Trial Registration: Clinicaltrials.gov NCT02637414; https://clinicaltrials.gov/ct2/show/NCT02637414. %M 31697244 %R 10.2196/14269 %U https://www.jmir.org/2019/11/e14269 %U https://doi.org/10.2196/14269 %U http://www.ncbi.nlm.nih.gov/pubmed/31697244 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 11 %P e13478 %T The Effectiveness of Web-Based Interventions Delivered to Children and Young People With Neurodevelopmental Disorders: Systematic Review and Meta-Analysis %A Khan,Kareem %A Hall,Charlotte L %A Davies,E Bethan %A Hollis,Chris %A Glazebrook,Cris %+ Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham, Innovation Park, Triumph Road, Nottingham, NG7 2TU, United Kingdom, 44 0115 8232438, kareem.khan@nottingham.ac.uk %K online intervention %K effectiveness %K neurodevelopmental disorders %K children and young people %K methodology %K systematic review %D 2019 %7 1.11.2019 %9 Review %J J Med Internet Res %G English %X Background: The prevalence of certain neurodevelopmental disorders, specifically autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD), has been increasing over the last four decades. Nonpharmacological interventions are available that can improve outcomes and reduce associated symptoms such as anxiety, but these are often difficult to access. Children and young people are using the internet and digital technology at higher rates than any other demographic, but although Web-based interventions have the potential to improve health outcomes in those with long-term conditions, no previous reviews have investigated the effectiveness of Web-based interventions delivered to children and young people with neurodevelopmental disorders. Objective: This study aimed to review the effectiveness of randomized controlled trials (RCTs) of Web-based interventions delivered to children and young people with neurodevelopmental disorders. Methods: Six databases and one trial register were searched in August and September 2018. RCTs were included if they were published in a peer-reviewed journal. Interventions were included if they (1) aimed to improve the diagnostic symptomology of the targeted neurodevelopmental disorder or associated psychological symptoms as measured by a valid and reliable outcome measure; (2) were delivered on the Web; (3) targeted a youth population (aged ≤18 years or reported a mean age of ≤18 years) with a diagnosis or suspected diagnosis of a neurodevelopmental disorder. Methodological quality was rated using the Joanna Briggs Institute Critical Appraisal Checklist for RCTs. Results: Of 5140 studies retrieved, 10 fulfilled the inclusion criteria. Half of the interventions were delivered to children and young people with ASDs with the other five targeting ADHD, tic disorder, dyscalculia, and specific learning disorder. In total, 6 of the 10 trials found that a Web-based intervention was effective in improving condition-specific outcomes or reducing comorbid psychological symptoms in children and young people. The 4 trials that failed to find an effect were all delivered by apps. The meta-analysis was conducted on five of the trials and did not show a significant effect, with a high level of heterogeneity detected (n=182 [33.4%, 182/545], 5 RCTs; pooled standardized mean difference=–0.39; 95% CI –0.98 to 0.20; Z=–1.29; P=.19 [I2=72%; P=.006]). Conclusions: Web-based interventions can be effective in reducing symptoms in children and young people with neurodevelopmental disorders; however, caution should be taken when interpreting these findings owing to methodological limitations, the minimal number of papers retrieved, and small samples of included studies. Overall, the number of studies was small and mainly limited to ASD, thus restricting the generalizability of the findings. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews: CRD42018108824; http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018108824 %M 31682573 %R 10.2196/13478 %U https://www.jmir.org/2019/11/e13478 %U https://doi.org/10.2196/13478 %U http://www.ncbi.nlm.nih.gov/pubmed/31682573 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 10 %P e14074 %T Identifying the Most Autonomy-Supportive Message Frame in Digital Health Communication: A 2x2 Between-Subjects Experiment %A Smit,Eline Suzanne %A Zeidler,Chamoetal %A Resnicow,Ken %A de Vries,Hein %+ Department of Communication Science, Amsterdam School of Communication Research, University of Amsterdam, PO Box 15791, Amsterdam, 1001 NG, Netherlands, 31 (0)625258558, E.S.Smit@uva.nl %K health communication %K health behavior %K personal autonomy %K internet %K health promotion %K healthy diet %K self-determination theory %D 2019 %7 30.10.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: The effectiveness of digital health communication may be increased by enhancing autonomy supportiveness. Objective: This study aimed to identify the most autonomy-supportive message frame within an intervention for increasing vegetable intake by testing the effect of the following 2 strategies: (1) using autonomy-supportive language and (2) providing choice. Methods: A Web-based 2 (autonomy-supportive vs controlling language)×2 (choice vs no choice) experiment was conducted among 526 participants, recruited via a research panel. The main outcome measures were perceived autonomy support (measured using the Virtual Care Climate Questionnaire, answered with scores 1 to 5), perceived relevance (measured with one question, answered with scores 1 to 5), and overall evaluation of the intervention (measured with 1 open-ended question, answered with scores 1 to 10). Results: Choice had a significant positive effect on the overall evaluation of the intervention (b=.12; P=.003), whereas for participants with a high need for autonomy, there was a significant positive effect on perceived relevance (b=.13; P=.02). The positive effect of choice on perceived autonomy support approached significance (b=.07; P=.07). No significant effects on any of the three outcomes were observed for language. Conclusions: Results suggest that provision of choice rather than the use of autonomy-supportive language can be an easy-to-implement strategy to increase the effectiveness of digital forms of health communication, especially for people with a high need for autonomy. %M 31670693 %R 10.2196/14074 %U http://www.jmir.org/2019/10/e14074/ %U https://doi.org/10.2196/14074 %U http://www.ncbi.nlm.nih.gov/pubmed/31670693 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 10 %P e12612 %T Assessment of the Efficacy, Safety, and Effectiveness of Weight Control and Obesity Management Mobile Health Interventions: Systematic Review %A Puigdomenech Puig,Elisa %A Robles,Noemí %A Saigí-Rubió,Francesc %A Zamora,Alberto %A Moharra,Montse %A Paluzie,Guillermo %A Balfegó,Mariona %A Cuatrecasas Cambra,Guillem %A Garcia-Lorda,Pilar %A Carrion,Carme %+ Faculty of Health Sciences, Universitat Oberta de Catalunya, Rambla del Poblenou, 156, Barcelona, Spain, 34 934 505 254, mcarrionr@uoc.edu %K mHealth %K obesity %K overweight %K systematic review %K technology assessment %D 2019 %7 25.10.2019 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: The use of apps to tackle overweight and obesity by tracking physical and dietary patterns and providing recommendations and motivation strategies to achieve personalized goals has increased over recent years. However, evidence of the efficacy, effectiveness, and safety of these apps is severely lacking. Objective: The aim of this study was to identify efficacy, safety, and effectiveness criteria used to assess weight control, overweight, and obesity management in mobile health (mHealth) interventions through a systematic review. Methods: PubMed, PsycINFO, Scopus, UK Trial Database, ClinicalTrials.gov, and the Cochrane Library were surveyed up to May 2018. All types of clinical studies were considered. A total of 2 independent reviewers assessed quality using Scottish Intercollegiate Guidelines Network (SIGN) criteria. Ratings were used to provide an overall score for each study (low, moderate, or high). Data were synthesized in evidence tables. Results: From 233 potentially relevant publications, only 28 studies were included. Of these, 13 (46%) were randomized control trials, 11 were single-arm studies (39%), 3 were nonrandomized controlled trials (11%), and 1 study was a cluster randomized trial (4%). The studies were classified as low (15), high (7), and moderate (6) quality according to SIGN criteria. All studies focused on efficacy, with only 1 trial mentioning safety and another 1 effectiveness. In 11 studies, the apps were used as stand-alone interventions, the others were multicomponent studies that included other tools for support such as sensors or websites. The main management tool included in the apps was feedback messaging (24), followed by goal-setting mechanisms (20) and self-monitoring (19). The majority of studies took weight or body mass index loss as the main outcome (22) followed by changes in physical activity (14) and diet (12). Regarding outputs, usability, adherence, and engagement (17) were the most reported, followed by satisfaction (7) and acceptability (4). Conclusions: There is a remarkable heterogeneity among these studies and the majority have methodological limitations that leave considerable room for improvement. Further research is required to identify all relevant criteria for assessing the efficacy of mHealth interventions in the management of overweight and obesity. Trial Registration: PROSPERO CRD42017056761; https://tinyurl.com/y2zhxtjx %M 31654566 %R 10.2196/12612 %U http://mhealth.jmir.org/2019/10/e12612/ %U https://doi.org/10.2196/12612 %U http://www.ncbi.nlm.nih.gov/pubmed/31654566 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 10 %P e13655 %T Improving the Course of Depressive Symptoms After Inpatient Psychotherapy Using Adjunct Web-Based Self-Help: Follow-Up Results of a Randomized Controlled Trial %A Zwerenz,Rüdiger %A Baumgarten,Carlotta %A Becker,Jan %A Tibubos,Ana %A Siepmann,Martin %A Knickenberg,Rudolf J %A Beutel,Manfred E %+ Department of Psychosomatic Medicine and Psychotherapy, University Medical Center, Johannes Gutenberg-University, Untere Zahlbacher Str 8, Mainz, 55131, Germany, 49 61311 75981, ruediger.zwerenz@unimedizin-mainz.de %K depression %K mental health %K internet %K aftercare %K psychotherapy %K psychology, clinical %K inpatients %D 2019 %7 24.10.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: We recently showed in a randomized controlled trial that Web-based self-help as an adjunct improved the effectiveness of multimodal inpatient psychotherapy for depression. Objective: The aims of this study were (1) to determine whether a Web-based self-help adjunctive to multimodal inpatient psychotherapeutic treatment could also improve the course of depressive symptoms and (2) to identify predictors of residual depressive symptoms at follow-up. Methods: Overall, 229 patients were randomized either to the Web-based self-help intervention group (Deprexis) or an active control group (Web-based information about depression and depressive symptoms) in addition to multimodal inpatient psychotherapy. Participants in both groups were able to access their respective Web-based programs for 12 weeks, which meant that they typically had access after discharge from the inpatient unit (mean hospitalization duration: 40 days, T1). Follow-up was performed 6 months after study intake (T3). Results: At follow-up, participants of the Web-based self-help group had considerably lower symptom load regarding depressive symptoms (d=0.58) and anxiety (d=0.46) as well as a better quality of life (d=0.43) and self-esteem (d=0.31) than participants of the control group. Nearly 3 times as many participants of the intervention group compared with the control group achieved remission in accordance with less deterioration. The number needed to treat based on the Beck Depression Inventory-II (BDI-II) improved over time (T1: 7.84, T2: 7.09, and T3: 5.12). Significant outcome predictors were BDI at discharge and treatment group. Conclusions: Web-based self-help as an add-on to multimodal inpatient psychotherapy improved the short-term course of depressive symptoms beyond termination. Residual symptoms at discharge from inpatient treatment and utilization of the Web-based self-help were the major predictors of depressive symptoms at follow-up. Challenges and barriers (eg, costs, therapists’ concerns, or technical barriers) of adding Web-based interventions to inpatient treatment have to be addressed. Trial Registration: ClinicalTrials.gov NCT02196896; https://clinicaltrials.gov/ct2/show/NCT02196896. %M 31651403 %R 10.2196/13655 %U https://www.jmir.org/2019/10/e13655 %U https://doi.org/10.2196/13655 %U http://www.ncbi.nlm.nih.gov/pubmed/31651403 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 6 %N 10 %P e11841 %T Web-Based Cognitive Bias Modification Interventions for Psychiatric Disorders: Scoping Review %A Zhang,Melvyn %A Ying,Jiangbo %A Song,Guo %A Fung,Daniel S S %A Smith,Helen %+ National Addictions Management Service, Institute of Mental Health, 10 Buangkok Green Medical Park, Singapore, 539747, Singapore, 65 63892504, melvynzhangweibin@gmail.com %K cognitive bias %K attention bias %K psychiatry %K eHealth %D 2019 %7 24.10.2019 %9 Review %J JMIR Ment Health %G English %X Background: Cognitive biases refer to automatic attentional or interpretational tendencies, which result in individuals with addictive disorders to automatically attend to substance-related stimuli and those with anxiety disorders to attend to threatening stimuli. To date, several studies have examined the efficacy of cognitive bias modification, and meta-analytical studies have synthesized the evidence for overall efficacy. The clinical utility of cognitive bias modification interventions has previously been limited to the confines of a laboratory, but recent advances in Web technologies can change this. Objective: This scoping review aimed to determine the scope of Web-based cognitive bias interventions and highlight their effectiveness. Methods: Databases (PubMed and MEDLINE, EMBASE, PsycINFO, ScienceDirect, and Cochrane Central) were searched from inception to December 5, 2017. The following search terminologies were used: (“attention bias” OR “cognitive bias” OR “approach bias” OR “avoidance bias” OR “interpretative bias”) AND (“Internet” OR “Web” OR “Online”). The methods for this scoping review are based on the previously published protocol. For the synthesis of the evidence, a narrative synthesis was undertaken, as a meta-analysis was not appropriate, given the lack of reported effect sizes and the heterogeneity in the outcomes reported. Results: Of the 2674 unique articles identified, we identified 22 randomized controlled studies that met our inclusion criteria: alcohol use disorder (n=2), tobacco use disorder (n=2), depressive disorder (n=3), anxiety and depressive symptoms in adolescents (n=3), obsessive-compulsive disorder (OCD; n=2), social anxiety disorder (n=9), and anxiety disorder (n=1). The sample sizes of these studies ranged from 16 to 434 participants. There is preliminary evidence to suggest that Web-based interventions could reduce biases among adolescents with heightened symptoms of anxiety and depression and among individuals with OCD. Conclusions: This is the first scoping review that mapped out the scope of cognitive bias modification interventions for psychiatric disorders. Web-based interventions have been applied predominantly for social anxiety and addictive disorders. Larger cohorts must be used in future studies to better determine the effectiveness of Web-based cognitive bias interventions. International Registered Report Identifier (IRRID): RR1-10.2196/10427 %M 31651410 %R 10.2196/11841 %U http://mental.jmir.org/2019/10/e11841/ %U https://doi.org/10.2196/11841 %U http://www.ncbi.nlm.nih.gov/pubmed/31651410 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 10 %P e13935 %T Mobile Health Coaching on Nutrition and Lifestyle Behaviors for Subfertile Couples Using the Smarter Pregnancy Program: Model-Based Cost-Effectiveness Analysis %A Oostingh,Elsje C %A Ophuis,Robbin H %A Koster,Maria PH %A Polinder,Suzanne %A Lingsma,Hester F %A Laven,Joop SE %A Steegers-Theunissen,Régine PM %+ Erasmus University Medical Center, Postbus 2040, Rotterdam, 3000 CA, Netherlands, 31 107038255, r.steegers@erasmusmc.nl %K preconception %K subfertility %K IVF treatment %K pregnancy %K cost-effectiveness %D 2019 %7 23.10.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The health care costs for reproductive care have substantially increased with the use of in vitro fertilization (IVF) treatment. The mobile health (mHealth) coaching program Smarter Pregnancy is an effective intervention to improve nutrition and lifestyle behaviors and pregnancy rates in (sub)fertile couples, including those who undergo IVF treatment. Therefore, we hypothesize that this mHealth program can also reduce health care costs associated with IVF treatment. Objective: This study aimed to evaluate the cost-effectiveness of the mHealth coaching program Smarter Pregnancy and compare it to usual care in women of subfertile couples who start their first IVF cycle. Methods: This model-based cost-effectiveness analysis was performed on data from couples undergoing IVF treatment at the Erasmus MC, University Medical Center Rotterdam. A decision tree model was used to assess the incremental cost-effectiveness ratio (ICER) of ongoing pregnancies and costs of use of the mHealth program as compared to usual care. A probabilistic sensitivity analysis was performed to consider the uncertainty surrounding the point estimates of the input parameters. Results: Based on our model including 793 subfertile women undergoing IVF treatment, use of the mHealth program resulted in 86 additional pregnancies and saved €270,000 compared to usual care after two IVF cycles, with an ICER of –€3050 (95% CI –3960 to –540) per additional pregnancy. The largest cost saving was caused by the avoided IVF treatment costs. Sensitivity analyses showed that the mHealth program needs to increase the ongoing pregnancy rate by at least 51% after two IVF cycles for cost saving. Conclusions: The mHealth coaching program Smarter Pregnancy is potentially cost saving for subfertile couples preceding their first IVF treatment. Implementation of this mHealth program in routine preconception care for subfertile couples should be seriously considered, given the relatively low costs and promising cost-effectiveness estimates. %M 31647476 %R 10.2196/13935 %U http://mhealth.jmir.org/2019/10/e13935/ %U https://doi.org/10.2196/13935 %U http://www.ncbi.nlm.nih.gov/pubmed/31647476 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 10 %P e13499 %T Electronic Health Record–Based Strategy to Promote Medication Adherence Among Patients With Diabetes: Longitudinal Observational Study %A Bailey,Stacy Cooper %A Wallia,Amisha %A Wright,Sarah %A Wismer,Guisselle A %A Infanzon,Alexandra C %A Curtis,Laura M %A Brokenshire,Samantha A %A Chung,Arlene E %A Reuland,Daniel S %A Hahr,Allison J %A Hornbuckle,Kenneth %A Lockwood,Karen %A Hall,Lori %A Wolf,Michael S %+ Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, 10th floor, 750 N Lake Shore Dr, Chicago, IL, 60611, United States, 1 312 503 5595, stacy-bailey@northwestern.edu %K health literacy %K medication adherence %K patient portal %K clinical decision support %D 2019 %7 21.10.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Poor medication adherence is common; however, few mechanisms exist in clinical practice to monitor how patients take medications in outpatient settings. Objective: This study aimed to pilot test the Electronic Medication Complete Communication (EMC2) strategy, a low-cost, sustainable approach that uses functionalities within the electronic health record to promote outpatient medication adherence and safety. Methods: The EMC2 strategy was implemented in 2 academic practices for 14 higher-risk diabetes medications. The strategy included: (1) clinical decision support alerts to prompt provider counseling on medication risks, (2) low-literacy medication summaries for patients, (3) a portal-based questionnaire to monitor outpatient medication use, and (4) clinical outreach for identified concerns. We recruited adult patients with diabetes who were prescribed a higher-risk diabetes medication. Participants completed baseline and 2-week interviews to assess receipt of, and satisfaction with, intervention components. Results: A total of 100 patients were enrolled; 90 completed the 2-week interview. Patients were racially diverse, 30.0% (30/100) had a high school education or less, and 40.0% (40/100) had limited literacy skills. About a quarter (28/100) did not have a portal account; socioeconomic disparities were noted in account ownership by income and education. Among patients with a portal account, 58% (42/72) completed the questionnaire; 21 of the 42 patients reported concerns warranting clinical follow-up. Of these, 17 were contacted by the clinic or had their issue resolved within 24 hours. Most patients (33/38, 89%) who completed the portal questionnaire and follow-up interview reported high levels of satisfaction (score of 8 or greater on a scale of 1-10). Conclusions: Findings suggest that the EMC2 strategy can be reliably implemented and delivered to patients, with high levels of satisfaction. Disparities in portal use may restrict intervention reach. Although the EMC2 strategy can be implemented with minimal impact on clinic workflow, future trials are needed to evaluate its effectiveness to promote adherence and safety. %M 31638592 %R 10.2196/13499 %U https://www.jmir.org/2019/10/e13499 %U https://doi.org/10.2196/13499 %U http://www.ncbi.nlm.nih.gov/pubmed/31638592 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 10 %P e14065 %T Development of the Therapeutic Alliance and its Association With Internet-Based Mindfulness-Based Cognitive Therapy for Distressed Cancer Patients: Secondary Analysis of a Multicenter Randomized Controlled Trial %A Bisseling,Else %A Cillessen,Linda %A Spinhoven,Philip %A Schellekens,Melanie %A Compen,Félix %A van der Lee,Marije %A Speckens,Anne %+ Radboudumc for Mindfulness, Department of Psychiatry, Radboud University Medical Center, 966/CvM, Postbus 9101, Nijmegen, 6500HB, Netherlands, 31 243615445, else.bisseling@radboudumc.nl %K therapeutic alliance %K telemedicine %K mindfulness %K cancer %K patient dropouts %D 2019 %7 18.10.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Mindfulness-based cognitive therapy (MBCT) is an evidence-based group-based psychological treatment in oncology, resulting in reduction of depressive and anxiety symptoms. Internet-based MBCT (eMBCT) has been found to be an effective alternative for MBCT. The therapeutic alliance (the bond between therapist and patient,) is known to have a significant impact on psychological treatment outcomes, including MBCT. A primary concern in the practice of eMBCT is whether a good therapeutic alliance can develop. Although evidence for the beneficial effect of therapist assistance on treatment outcome in internet-based interventions (IBIs) is accumulating, it is still unclear whether the therapeutic alliance is related to outcome in IBIs. Objective: This study aimed to (1) explore whether early therapeutic alliance predicts treatment dropout in MBCT or eMBCT, (2) compare the development of the therapeutic alliance during eMBCT and MBCT, and (3) examine whether early therapeutic alliance is a predictor of the reduction of psychological distress and the increase of mental well-being at posttreatment in both conditions. Methods: This study was part of a multicenter randomized controlled trial (n=245) on the effectiveness of MBCT or eMBCT for distressed cancer patients. The therapeutic alliance was measured at the start of week 2 (ie, early therapeutic alliance), week 5, and week 9. Outcome measures were psychological distress, measured with the Hospital Anxiety and Depression Scale, and mental well-being, measured with the Mental Health Continuum-Short Form. Results: The strength of early therapeutic alliance did not predict treatment dropout in MBCT or eMBCT (B=−.39; P=.21). Therapeutic alliance increased over time in both conditions (F2,90=16.46; Wilks λ=0.732; P<.001). This increase did not differ between eMBCT and MBCT (F1,91=0.114; P=.74). Therapeutic alliance at week 2 predicted a decrease in psychological distress (B=−.12; t114=−2.656; P=.01) and an increase in mental well-being (B=.23; t113=2.651; P=.01) at posttreatment. The relationship with reduction of psychological distress differed between treatments: a weaker early therapeutic alliance predicted higher psychological distress at posttreatment in MBCT but not in eMBCT (B=.22; t113=2.261; P=.03). Conclusions: A therapeutic alliance can develop in both eMBCT and MBCT. Findings revealed that the strength of early alliance did not predict treatment dropout. Furthermore, the level of therapeutic alliance predicted reduced psychological distress and increased mental well-being at posttreatment in both conditions. Interestingly, the strength of therapeutic alliance appeared to be more related to treatment outcome in group-based MBCT than in eMBCT. Trial Registration: ClinicalTrials.gov NCT02138513; https://clinicaltrials.gov/ct2/show/NCT02138513 %M 31628791 %R 10.2196/14065 %U https://www.jmir.org/2019/10/e14065 %U https://doi.org/10.2196/14065 %U http://www.ncbi.nlm.nih.gov/pubmed/31628791 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 10 %P e14772 %T Reduced Hospitalizations, Emergency Room Visits, and Costs Associated with a Web-Based Health Literacy, Aligned-Incentive Intervention: Mixed Methods Study %A Greene,Jeffrey C %A Haun,Jolie N %A French,Dustin D %A Chambers,Susan L %A Roswell,Robert H %+ MedEncentive, 755 Research Parkway, Suite 440, Oklahoma City, OK, , United States, 1 405 627 9351, jgreene@medencentive.com %K cost control %K health care costs %K health literacy %K information therapy %K aligned incentives %K mutual accountability %D 2019 %7 17.10.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: The association between health literacy and health care costs, particularly for hospitalizations and emergency room services, has been previously observed. Health information interventions aimed at addressing the negative impacts of inadequate health literacy are needed. The MedEncentive Mutual Accountability and Information Therapy (MAIT) Program is a Web-based system designed to improve health and lower costs by aligning patient-doctor incentives. Objective: In this mixed methods study of a Web-based patient-doctor aligned-incentive, information therapy program conducted in an 1800-member employee health plan, we aimed to (1) determine the program’s quantitative impact on hospitalization and emergency room utilization and costs, and (2) assess survey responses about the program’s perceived value. Methods: We used a mixed methods, single within-group, pre-post, descriptive study design. We analyzed quantitative data using pre-post mean utilization and cost differences and summarized the data using descriptive statistics. We used open-ended electronic survey items to collect descriptive data and analyzed them using thematic content analysis. Results: Hospitalizations and emergency room visits per 1000 decreased 32% (26.5/82.4) and 14% (31.3/219.9), respectively, after we implemented the program in 2015-2017, relative to 2013-2014. Correspondingly, the plan’s annual per capita expenditures declined US $675 (95% CI US $470-865), or 10.8% ($675/$6260), after program implementation in 2015-2017 (US $5585 in 2013-2014 dollars), relative to the baseline years of 2013-2014 (US $6260; P<.05). Qualitative findings suggested that respondents valued the program, benefiting from its educational and motivational aspects to better self-manage their health. Conclusions: Analyses suggested that the reported reductions in hospitalizations, emergency room visits, and costs were associated with the program. Qualitative findings indicated that targeted users perceived value in participating in the MAIT Program. Further research with controls is needed to confirm these outcomes and more completely understand the health improvement and cost-containment capabilities of this Web-based health information, patient-doctor, aligned-incentive program. %M 31625948 %R 10.2196/14772 %U https://www.jmir.org/2019/10/e14772 %U https://doi.org/10.2196/14772 %U http://www.ncbi.nlm.nih.gov/pubmed/31625948 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 10 %P e14254 %T A Comparison of Users and Nonusers of a Web-Based Intervention for Carers of Older Persons With Alzheimer Disease and Related Dementias: Mixed Methods Secondary Analysis %A Duggleby,Wendy %A Ploeg,Jenny %A McAiney,Carrie %A Fisher,Kathryn %A Jovel Ruiz,Kathya %A Ghosh,Sunita %A Peacock,Shelley %A Markle-Reid,Maureen %A Williams,Allison %A Triscott,Jean %A Swindle,Jennifer %+ Faculty of Nursing, University of Alberta, 11405 87th Ave, Edmonton, AB, T6G 1C9, Canada, 1 7804928660, wendy.duggleby@ualberta.ca %K Web-based intervention %K carers %K dementia %K multiple chronic conditions %K program evaluation %D 2019 %7 17.10.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: A self-administered Web-based intervention was developed to help carers of persons with Alzheimer disease and related dementias (ADRD) and multiple chronic conditions (MCC) deal with the significant transitions they experience. The intervention, My Tools 4 Care (MT4C), was evaluated during a pragmatic mixed methods randomized controlled trial with 199 carers. Those in the intervention group received free, password-protected access to MT4C for three months. MT4C was found to increase hope in participants at three months compared with the control group. However, in the intervention group, 22% (20/92) did not use MT4C at all during the three-month period. Objective: This mixed methods secondary analysis aimed to (1) examine differences at three months in the outcomes of hope, self-efficacy, and health-related quality of life (HRQOL) scores in users (ie, those who used MT4C at least once during the three-month period) compared with nonusers and (2) identify reasons for nonuse. Methods: Data from the treatment group of a pragmatic mixed methods randomized controlled trial were used. Through audiotaped telephone interviews, trained research assistants collected data on participants’ hope (Herth Hope Index; HHI), self-efficacy (General Self-Efficacy Scale; GSES), and HRQOL (Short-Form 12-item health survey version 2; SF-12v2) at baseline, one month, and three months. Treatment group participants also provided feedback on MT4C through qualitative telephone interviews at one month and three months. Analysis of covariance was used to determine differences at three months, and generalized estimating equations were used to determine significant differences in HHI, GSES, and SF-12v2 between users and nonusers of MT4C from baseline to three months. Interview data were analyzed using content analysis and integrated with quantitative data at the result stage. Results: Of the 101 participants at baseline, 9 (9%) withdrew from the study, leaving 92 participants at three months of which 72 (78%) used MT4C at least once; 20 (22%) participants did not use it at all. At baseline, there were no statistically significant differences in demographic characteristics and in outcome variables (HHI, GSES, and SF-12v2 mental component score and physical component score) between users and nonusers. At three months, participants who used MT4C at least once during the three-month period (users) reported higher mean GSES scores (P=.003) than nonusers. Over time, users had significantly higher GSES scores than nonusers (P=.048). Reasons for nonuse of MT4C included the following: caregiving demands, problems accessing MT4C (poor connectivity, computer literacy, and navigation of MT4C), and preferences (for paper format or face-to-face interaction). Conclusions: Web-based interventions, such as MT4C, have the potential to increase the self-efficacy of carers of persons with ADRD and MCC. Future research with MT4C should consider including educational programs for computer literacy and providing alternate ways to access MT4C in addition to Web-based access. Trial Registration: ClinicalTrials.gov NCT02428387; https://clinicaltrials.gov/ct2/show/NCT02428387 %M 31625947 %R 10.2196/14254 %U https://www.jmir.org/2019/10/e14254 %U https://doi.org/10.2196/14254 %U http://www.ncbi.nlm.nih.gov/pubmed/31625947 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 10 %P e13073 %T Feasibility, Acceptability, and Preliminary Impacts of Web-Based Patient Education on Patients With Schizophrenia Spectrum Disorder: Quasi-Experimental Cluster Study %A Laine,Anna %A Välimäki,Maritta %A Pekurinen,Virve %A Löyttyniemi,Eliisa %A Marttunen,Mauri %A Anttila,Minna %+ Department of Nursing Science, University of Turku, Joukahaisenkatu 3-5, 20014 University of Turku, Turku, Finland, 358 406890546, mava@utu.fi %K mental health %K patient education %K schizophrenia %K feasibility study %K internet %K information system %D 2019 %7 17.10.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based interventions are promising tools for increasing the understanding of illness and treatment among patients with serious mental disorders. Objective: This study aimed to test the feasibility and acceptability of a Web-based patient education intervention using a quasi-experimental cluster design to report feedback on patient education sessions and the website used and to report preliminary evidence of the intervention’s impact on patients with schizophrenia spectrum disorder. Methods: A single-blind, parallel, quasi-experimental cluster study over a 6-month period comparing Web-based education (n=33) with a nonequivalent control group (treatment as usual, n=24) for people with schizophrenia spectrum disorder was conducted. Participants (N=57) were recruited from one psychiatric hospital (6 wards). Feasibility was assessed by participants’ commitment (refusal rate, dropout rate) to the study. Acceptability was assessed as participants’ commitment to the intervention. Patient education sessions and website feedback were assessed by the patients and health care professionals. The preliminary impact of the sessions on patients’ self-efficacy, self-esteem, illness cognition, and knowledge level was measured at baseline and follow-ups (8 weeks, 6 months) with self-rated questionnaires. Results: The refusal rate among patients was high with no statistically significant difference (69% [74/107] in the intervention group, 76% [76/100] in the control group; P=.21). The same result was found for the dropout rates (48% [16/33] vs 58% [14/24]; P=.46). The acceptability of the intervention was good; 31 participants out of 33 (94%) completed all five sessions. Feedback on the intervention was mainly positive; three out of four subscales of session were rated above the midpoint of 4.0. Feedback on the website was also positive, with a grade of good for content (69%, 20/29 patients; 75%, 21/28 professionals), layout (62%, 18/29 patients; 61%, 17/28 professionals), and usability (62%, 18/29 patients; and 68%, 19/28 professionals). The patients using the intervention had significantly higher scores 6 months after the sessions in self-efficacy (baseline mean 26.12, SD 5.64 vs 6-month mean 29.24, SD 6.05; P=.003) and regarding knowledge level about schizophrenia (mean 11.39, SD 4.65 vs 6-month mean 15.06, SD 5.26; P=.002), and lower scores in the subscale of helplessness in illness cognition (mean 2.26, SD 0.96 vs 6-month mean 1.85, SD 0.59; P=.03). Differences from the control group were not significant. No differences were found in patients’ self-esteem or other subscales in illness cognition. Conclusions: The patients were reluctant to participate in the study and tended to drop out before the follow-ups. Once they had participated, their acceptance of the intervention was high. A more effective recruitment strategy and monitoring method will be needed in future studies. To assess the impact of the intervention, a more rigorous study design with an adequately powered sample size will be used in cooperation with outpatient mental health services. %M 31625952 %R 10.2196/13073 %U http://www.jmir.org/2019/10/e13073/ %U https://doi.org/10.2196/13073 %U http://www.ncbi.nlm.nih.gov/pubmed/31625952 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 10 %P e13606 %T Identifying Frameworks for Validation and Monitoring of Consensual Behavioral Intervention Technologies: Narrative Review %A Carbonnel,François %A Ninot,Gregory %+ University Department of General Practice, University of Montpellier, 641 Avenue du Doyen Giraud, UFR Médecine site Nord, Montpellier, 34093, France, 33 684014834, francois.carbonnel@gmail.com %K behavioral intervention technology %K validation %K surveillance %K paradigm %K framework %K nonpharmacological interventions %D 2019 %7 16.10.2019 %9 Review %J J Med Internet Res %G English %X Background: Changing health behaviors, such as smoking, unhealthy eating, inactivity, and alcohol abuse, may have a greater impact on population health than any curative strategy. One of the suggested strategies is the use of behavioral intervention technologies (BITs). They open up new opportunities in the area of prevention and therapy and have begun to show benefits in the durable change of health behaviors in patients or those at risk. A consensual and international paradigm was adopted by health authorities for drugs 50 years ago. It guides their development from research units to their authorization and surveillance. BITs’ generalization brings into question their upstream evaluation before being placed on the market and their downstream monitoring once on the market; this is especially the case in view of the marketing information provided by manufacturers and the scarcity and methodological limits of scientific studies on these tools. Objective: This study aims to identify and categorize the frameworks for the validation and monitoring of BITs proposed in the literature. Methods: We conducted a narrative literature review using MEDLINE, PsycINFO, and Web of Science. The review items included the following: name, publication year, name of the creator (ie, first author), country, funding organization, health focus, target group, and design (ie, linear, iterative, evolutive, and/or concurrent). The frameworks were then categorized based on (1) translational research thanks to a continuum of steps and (2) the three paradigms that may have inspired the frameworks: biomedical, engineering, and/or behavioral. Results: We identified 46 frameworks besides the classic US Food and Drug Administration (FDA) five-phase drug development model. A total of 57% (26/46) of frameworks were created in the 2010s and 61% (28/46) involved the final user in an early and systematic way. A total of 4% (2/46) of frameworks had a linear-only sequence of their phases, 37% (17/46) had a linear and iterative structure, 33% (15/46) added an evolutive structure, and 24% (11/46) were associated with a parallel process. Only 12 out of 46 (26%) frameworks covered the continuum of steps and 12 (26%) relied on the three paradigms. Conclusions: To date, 46 frameworks of BIT validation and surveillance coexist, besides the classic FDA five-phase drug development model, without the predominance of one of them or convergence in a consensual model. Their number has increased exponentially in the last three decades. Three dangerous scenarios are possible: (1) anarchic continuous development of BITs that depend on companies amalgamating health benefits and usability (ie, user experience, data security, and ergonomics) and limiting implementation to several countries; (2) the movement toward the type of framework for drug evaluation centered on establishing its effectiveness before marketing authorization to guarantee its safety for users, which is heavy and costly; and (3) the implementation of a framework reliant on big data analysis based on a posteriori research and an autoregulation of a market, but that does not address the safety risk for the health user, as the market will not regulate safety or efficacy issues. This paper recommends convergence toward an international validation and surveillance framework based on the specificities of BITs, not equivalent to medical devices, to guarantee their effectiveness and safety for users. %M 31621638 %R 10.2196/13606 %U https://www.jmir.org/2019/10/e13606 %U https://doi.org/10.2196/13606 %U http://www.ncbi.nlm.nih.gov/pubmed/31621638 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 10 %P e13674 %T Development and Efficacy of an Electronic, Culturally Adapted Lifestyle Counseling Tool for Improving Diabetes-Related Dietary Knowledge: Randomized Controlled Trial Among Ethnic Minority Adults With Type 2 Diabetes Mellitus %A Abu-Saad,Kathleen %A Murad,Havi %A Barid,Rivka %A Olmer,Liraz %A Ziv,Arnona %A Younis-Zeidan,Nuha %A Kaufman-Shriqui,Vered %A Gillon-Keren,Michal %A Rigler,Shmuel %A Berchenko,Yakir %A Kalter-Leibovici,Ofra %+ Cardiovascular Epidemiology Unit, Gertner Institute for Epidemiology and Health Policy Research, Sheba Medical Center, Ramat Gan, 52621, Israel, 972 526896782, kathleena@gertner.health.gov.il %K diabetes mellitus, type 2 %K diabetes-related dietary knowledge %K lifestyle %K software %K culturally congruent care %K ethnic minorities %D 2019 %7 16.10.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Ethnic minority populations exhibit disproportionately high rates of type 2 diabetes mellitus (T2DM). Electronic health tools have the potential to facilitate the cultural adaptation and tailoring of T2DM education to improve the knowledge and management of diabetes mellitus (DM). Objective: This study aimed (1) to develop an adaptable Interactive Lifestyle Assessment, Counseling, and Education (I-ACE) software to support dietitian-delivered lifestyle counseling among low-socioeconomic status (SES) ethnic minority patients with T2DM and (2) to evaluate its effect on DM-related dietary knowledge and management compared with standard lifestyle advice (SLA) in a randomized controlled trial (RCT). Methods: The I-ACE software, developed in consultation with clinical dieticians, incorporates evidence-based dietary and physical activity (PA) recommendations and educational materials. The features and behavioral change techniques include quantitative lifestyle (dietary intake and PA) assessment and simulation, individually tailored education and recommendations, motivational interviewing, and goal setting. For the unblinded pilot RCT, 50 overweight or obese Arab adults (aged 40-62 years) with poorly controlled T2DM were recruited from primary care clinics and randomly assigned to receive 4 in-person, dietician-delivered counseling sessions over 6 months using either (1) the I-ACE tool (experimental arm) or (2) the SLA methods (comparison arm). All outcome assessments were face-to-face. DM-related dietary knowledge (primary outcome) was measured at baseline, 3, 6, and 12 months. Lifestyle and other parameters were measured before, during, and after the intervention. Multiple linear regression and repeated measures linear mixed models were used to compare the changes in study outcomes and explore time trends in between-group and within-group changes. Results: A total of 25 participants were enrolled in each arm, of whom 24 and 21 completed the final assessment of the primary outcome in the I-ACE and SLA arms, respectively. DM-related lifestyle knowledge increased more rapidly in the I-ACE arm than in the SLA arm (P value for study arm×time interaction=.02). Within the I-ACE arm, the mean (SE) differences in added sugar and dietary fiber intakes from baseline to 12 months were −2.6% (SE 1.0%) of total energy (P=.03) and 2.7 (SE 0.0) g/1000 kcal (P=.003), respectively. The odds of engaging in any leisure PA at 12 months tended to be higher in the I-ACE arm versus SLA arm, but did not reach statistical significance (odds ratio 2.8; 95% CI 0.7-11.6; P=.16). Both arms exhibited significant reductions in HbA1c (P value for change over time <.001). Conclusions: The use of the I-ACE software in a 6-month, 4-session dietician-delivered lifestyle counseling intervention improved the efficiency of lifestyle education, compared with SLA, among low-SES, ethnic minority patients with T2DM. This pilot trial provides justification for conducting a large-scale trial to evaluate its effectiveness and applicability in routine clinical care among ethnically diverse populations. Trial Registration: ClinicalTrials.gov NCT01858506; https://clinicaltrials.gov/ct2/show/NCT01858506. %M 31621640 %R 10.2196/13674 %U https://www.jmir.org/2019/10/e13674 %U https://doi.org/10.2196/13674 %U http://www.ncbi.nlm.nih.gov/pubmed/31621640 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 10 %P e13002 %T Process Evaluation of Nurse-Led Online Self-Management Support for Family Caregivers to Deal With Behavior Changes of a Relative With Dementia (Part 1): Mixed Methods Study %A Huis in het Veld,Judith G %A van Asch,Iris F M %A Willemse,Bernadette M %A Verkade,Paul-Jeroen %A Pot,Anne Margriet %A Blom,Marco M %A Groot Zwaaftink,Rob B M %A Francke,Anneke L %+ Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Van der Boechorststraat 7, Amsterdam, 1081 BT, Netherlands, 31 20 44 45 365, j.huisinhetveld@vumc.nl %K dementia %K internet %K eHealth %K caregiver %D 2019 %7 11.10.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Coping with behavioral changes is a daily challenge for family caregivers in all phases of dementia, and assistance is needed for it. An online self-management support intervention was therefore developed and conducted involving the following elements: (1) email contact with a specialized dementia nurse, (2) online videos, and (3) e-bulletins containing information about behavior changes and how to manage them. Objective: The aim of this study was to understand (1) family caregivers’ actual use of various elements of the online self-management support, (2) family caregivers’ evaluation and satisfaction with the various elements, and (3) nurses’ usage and evaluations of the online support through the tailored email contacts. Methods: A mixed methods design was used in this process evaluation, combining quantitative and qualitative methods including analyses of dementia nurses’ registration forms, the number of clicks on online videos and e-bulletins, evaluation questions answered by family caregivers in a survey questionnaire, semistructured interviews with family caregivers and nurses, and analysis of the content of the email contacts. Results: The actual use of various elements of the online self-management support by family caregivers varied: 78% (21/27) of family caregivers had an email contact with the specialist nurse, 80% (43/54) of family caregivers clicked on an online video, and 37% (30/81) clicked on an e-bulletin. Family caregivers showed positive evaluations and satisfaction. The tailor-made approach in the personal email contacts in particular was valued by the family caregivers. Nurses’ evaluations about providing self-management support online were mixed as it was a relatively new task for them. Conclusions: An important insight is that not all participants made optimum use of the various elements of the intervention. Nurses also said that the email contacts were more often used to express feelings about coping with behavioral changes. More research is needed to investigate the reasons why people accept, adopt, and adhere to online interventions to reduce cases where they are not used and to back them up appropriately with tailored (online) information and advice for their personal situations. %M 31605517 %R 10.2196/13002 %U https://www.jmir.org/2019/10/e13002 %U https://doi.org/10.2196/13002 %U http://www.ncbi.nlm.nih.gov/pubmed/31605517 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 10 %P e14037 %T Internet-Based Cognitive Behavioral Therapy for Chronic Fatigue Syndrome Integrated in Routine Clinical Care: Implementation Study %A Worm-Smeitink,Margreet %A van Dam,Arno %A van Es,Saskia %A van der Vaart,Rosalie %A Evers,Andrea %A Wensing,Michel %A Knoop,Hans %+ Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, PO Box 22660, 1100DD, Amsterdam,, Netherlands, 31 20 4443925, hans.knoop@amsterdamumc.nl %K eHealth %K cognitive behavioral therapy %K health plan implementation %K chronic fatigue syndrome %K attitudes %D 2019 %7 10.10.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: In a clinical trial, internet-based cognitive behavioral therapy (I-CBT) embedded in stepped care was established as noninferior to face-to-face cognitive behavioral therapy (CBT) for chronic fatigue syndrome (CFS). However, treatment effects observed in clinical trials may not necessarily be retained after implementation. Objective: This study aimed to investigate whether stepped care for CFS starting with I-CBT, followed by face-to-face CBT, if needed, was also effective in routine clinical care. Another objective was to explore the role of therapists’ attitudes toward electronic health (eHealth) and manualized treatment on treatment outcome. Methods: I-CBT was implemented in five mental health care centers (MHCs) with nine treatment sites throughout the Netherlands. All patients with CFS were offered I-CBT, followed by face-to-face CBT if still severely fatigued or disabled after I-CBT. Outcomes were the Checklist Individual Strength, physical and social functioning (Short-Form 36), and limitations in daily functioning according to the Work and Social Adjustment Scale. The change scores (pre to post stepped care) were compared with a benchmark: stepped care from a randomized controlled trial (RCT) testing this treatment format. We calculated correlations of therapists’ attitudes toward manualized treatment and eHealth with reduction of fatigue severity. Results: Overall, 100 CFS patients were referred to the centers. Of them, 79 started with I-CBT, 20 commenced directly with face-to-face CBT, and one did not start at all. After I-CBT, 48 patients met step-up criteria; of them, 11 stepped up to face-to-face CBT. Increase in physical functioning (score of 13.4), social functioning (20.4), and reduction of limitations (10.3) after stepped care delivered in routine clinical care fell within the benchmarks of the RCT (95% CIs: 12.8-17.6; 25.2-7.8; and 7.4-9.8, respectively). Reduction of fatigue severity in the MHCs was smaller (12.6) than in the RCT (95% CI 13.2-16.5). After I-CBT only, reduction of fatigue severity (13.2) fell within the benchmark of I-CBT alone (95% CI 11.1-14.2). Twenty therapists treated between one and 18 patients. Therapists were divided into two groups: one with the largest median reduction of fatigue and one with the smallest. Patients treated by the first group had a significantly larger reduction of fatigue severity (15.7 vs 9.0; t=2.42; P=.02). There were no (statistically significant) correlations between therapists’ attitudes and reduction in fatigue. Conclusions: This study is one of the first to evaluate stepped care with I-CBT as a first step in routine clinical care. Although fatigue severity and disabilities were reduced, reduction of fatigue severity appeared smaller than in the clinical trial. Further development of the treatment should aim at avoiding dropout and encouraging stepping up after I-CBT with limited results. Median reduction of fatigue severity varied largely between therapists. Further research will help understand the role of therapists’ attitudes in treatment outcome. %M 31603428 %R 10.2196/14037 %U http://www.jmir.org/2019/10/e14037/ %U https://doi.org/10.2196/14037 %U http://www.ncbi.nlm.nih.gov/pubmed/31603428 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 10 %P e15814 %T Estimating the Impact of Novel Digital Therapeutics in Type 2 Diabetes and Hypertension: Health Economic Analysis %A Nordyke,Robert J %A Appelbaum,Kevin %A Berman,Mark A %+ Better Therapeutics, LLC, 445 Bush Street, Suite 300, San Francisco, CA, United States, 1 617 877 0327, mark@bettertherapeutics.io %K digital therapeutics %K behavioral intervention %K economic evaluation %K diabetes %K hypertension %D 2019 %7 9.10.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Behavioral interventions can meaningfully improve cardiometabolic conditions. Digital therapeutics (DTxs) delivering these interventions may provide benefits comparable to pharmacologic therapies, displacing medications for some patients. Objective: Our objective was to estimate the economic impact of a digital behavioral intervention in type 2 diabetes mellitus (T2DM) and hypertension (HTN) and estimate the impact of clinical inertia on deprescribing medications. Methods: Decision analytic models estimated health resource savings and cost effectiveness from a US commercial payer perspective. A 3-year time horizon was most relevant to the intervention and payer. Effectiveness of the DTx in improving clinical outcomes was based on cohort studies and published literature. Health resource utilization (HRU), health state utilities, and costs were drawn from the literature with costs adjusted to 2018 dollars. Future costs and quality-adjusted life years (QALYs) were discounted at 3%. Sensitivity analyses assessed uncertainty. Results: Average HRU savings ranged from $97 to $145 per patient per month, with higher potential benefits in T2DM. Cost-effectiveness acceptability analyses using a willingness-to-pay of $50,000/QALY indicated that the intervention would be cost effective at total 3-year program costs of $6468 and $6620 for T2DM and HTN, respectively. Sensitivity analyses showed that reduced medication costs are a primary driver of potential HRU savings, and the results were robust within values tested. A resistance to deprescribe medications when a patient’s clinical outcomes improve can substantially reduce the estimated economic benefits. Our models rely on estimates of clinical effectiveness drawn from limited cohort studies with DTxs and cannot account for other disease management programs that may be implemented. Performance of DTxs in real-world settings is required to further validate their economic benefits. Conclusions: The DTxs studied may provide substantial cost savings, in part by reducing the use of conventional medications. Clinical inertia may limit the full cost savings of DTxs. %M 31599740 %R 10.2196/15814 %U https://www.jmir.org/2019/10/e15814 %U https://doi.org/10.2196/15814 %U http://www.ncbi.nlm.nih.gov/pubmed/31599740 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 10 %P e13219 %T Results of MyPlan 2.0 on Physical Activity in Older Belgian Adults: Randomized Controlled Trial %A Van Dyck,Delfien %A Herman,Karel %A Poppe,Louise %A Crombez,Geert %A De Bourdeaudhuij,Ilse %A Gheysen,Freja %+ Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, Watersportlaan 2, Ghent, 9000, Belgium, 32 92646323, delfien.vandyck@ugent.be %K self-regulation %K exercise %K elderly %K eHealth %D 2019 %7 7.10.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: The beneficial effects of physical activity (PA) for older adults are well known. However, few older adults reach the health guideline of 150 min per week of moderate-to-vigorous PA (MVPA). Electronic health (eHealth) interventions are effective in increasing PA levels in older adults in the short term but, rarely, intermediate-term effects after a period without the support of a website or an app have been examined. Furthermore, current theory-based interventions focus mainly on preintentional determinants, although postintentional determinants should also be included to increase the likelihood of successful behavior change. Objective: This study aimed to investigate the effect of the theory-based eHealth intervention, MyPlan 2.0, focusing on pre- and postintentional determinants on both accelerometer-based and self-reported PA levels in older Belgian adults in the short and intermediate term. Methods: This study was a randomized controlled trial with three data collection points: baseline (N=72), post (five weeks after baseline; N=65), and follow-up (three months after baseline; N=65). The study took place in Ghent, and older adults (aged ≥65 years) were recruited through a combination of random and convenience sampling. At all the time points, participants were visited by the research team. Self-reported domain-specific PA was assessed using the International Physical Activity Questionnaire, and accelerometers were used to objectively assess PA. Participants in the intervention group got access to the eHealth intervention, MyPlan 2.0, and used it independently for five consecutive weeks after baseline. MyPlan 2.0 was based on the self-regulatory theory and focused on both pre- and postintentional processes to increase PA. Multilevel mixed-models repeated measures analyses were performed in R (R Foundation for Statistical Computing). Results: Significant (borderline) positive intervention effects were found for accelerometer-based MVPA (baseline−follow-up: intervention group +5 min per day and control group −5 min per day; P=.07) and for accelerometer-based total PA (baseline−post: intervention group +20 min per day and control group −24 min per day; P=.05). MyPlan 2.0 was also effective in increasing self-reported PA, mainly in the intermediate term. A positive intermediate-term intervention effect was found for leisure-time vigorous PA (P=.02), moderate household-related PA (P=.01), and moderate PA in the garden (P=.04). Negative intermediate-term intervention effects were found for leisure-time moderate PA (P=.01) and cycling for transport (P=.07). Conclusions: The findings suggest that theory-based eHealth interventions focusing on pre- and postintentional determinants have the potential for behavior change in older adults. If future studies including larger samples and long-term follow-up can confirm and clarify these findings, researchers and practitioners should be encouraged to use a self-regulation perspective for eHealth intervention development. Trial Registration: Clinicaltrials.gov NCT03194334; https://clinicaltrials.gov/ct2/show/NCT03783611. %M 31593541 %R 10.2196/13219 %U https://www.jmir.org/2019/10/e13219 %U https://doi.org/10.2196/13219 %U http://www.ncbi.nlm.nih.gov/pubmed/31593541 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 10 %P e14112 %T Promoting Social Connection and Deepening Relations Among Older Adults: Design and Qualitative Evaluation of Media Parcels %A Zaine,Isabela %A Frohlich,David Mark %A Rodrigues,Kamila Rios Da Hora %A Cunha,Bruna Carolina Rodrigues %A Orlando,Alex Fernando %A Scalco,Leonardo Fernandes %A Pimentel,Maria Da Graça Campos %+ University of São Paulo, Institute of Mathematics and Computer Sciences, Avenida Trabalhador São Carlense, 400 - Parque Arnold Schimidt, São Carlos - SP, 13566-590, Brazil, 55 163373 9700, isabela.zaine@gmail.com %K social interaction %K interpersonal relations %K communication %K intervention %K experience sampling %K mobile apps %K photography %K video-audio media %K elderly %D 2019 %7 3.10.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Being socially connected is related to well-being, and one way of avoiding social isolation is to deepen existing relationships. Even though existing relationships can be reinforced by regular and meaningful communication, state-of-the-art communication technologies alone do not increase the quality of social connections. Thus, there is a need for the involvement of a trained human facilitator in a network of older adults, preferably for a short period, to promote the deepening of their relationships. Objective: This study aimed to evaluate the hypothesis that a human-facilitated, media-sharing social networking system can improve social connection in a small group of older people, who are more vulnerable to social isolation than most, and deepen their relationships over a period of a few weeks. Methods: We conducted the design and evaluation of Media Parcels, a novel human-facilitated social networking system. Media Parcels is based on the metaphor of a facilitator collecting and delivering parcels in the physical mail. Extending the metaphor, the system supports a facilitator in designing time-based dialogue requesting parcels from participants that bring out their memories and feelings, in collecting the parcels, wrapping them in annotations that communicate the corresponding requests, and delivering the wrapped parcel to a target person. Qualitative evaluation was carried out in two trials with a group of three people each, one with family members (children and father; aged 55, 56, and 82 years old) and the other with a group of friends (aged 72, 72, and 74 years old), over two weeks. In each trial, data were collected in three interviews (pre-, mid-, and posttrial) and via system logging. Results: Collected data indicate positive social effects for deepening and developing relationships. The parcel metaphor was easily understood and the computational system was readily adopted. Preferences with regard to media production or consumption varied among participants. In the family group, children preferred receiving media parcels (because of their sentimental value) to producing them, whereas the father enjoyed both. In the friendship group, preferences varied: one friend enjoyed both producing and receiving, while the other two preferred one over the other. In general, participants reported a preference for the production of items of a certain type depending on the associated content. Apart from having a strong engagement with the system, participants reported feeling closer to each other than usual. Conclusions: For both groups, Media Parcels was effective in promoting media sharing and social connections, resulting in the deepening of existing relationships. Its design informs researchers who are attempting to promote social connection in older adults. %M 31584001 %R 10.2196/14112 %U https://www.jmir.org/2019/10/e14112 %U https://doi.org/10.2196/14112 %U http://www.ncbi.nlm.nih.gov/pubmed/31584001 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 10 %P e14834 %T A Web-Based Intervention for Social Media Addiction Disorder Management in Higher Education: Quantitative Survey Study %A Dogan,Huseyin %A Norman,Helmi %A Alrobai,Amen %A Jiang,Nan %A Nordin,Norazah %A Adnan,Anita %+ Faculty of Education, Universiti Kebangsaan Malaysia, Jalan Reko, Bangi, 43600, Malaysia, 60 389216062, helmi.norman@ukm.edu.my %K Facebook addiction %K intervention features %K postgraduate education %K social media addiction %K obsessive-compulsive disorder (OCD) %K PLS-SEM analysis %D 2019 %7 2.10.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Social media addiction disorder has recently become a major concern and has been reported to have negative impacts on postgraduate studies, particularly addiction to Facebook. Although previous studies have investigated the effects of Facebook addiction disorder in learning settings, there still has been a lack of studies investigating the relationship between online intervention features for Facebook addiction focusing on postgraduate studies. Objective: In an attempt to understand this relationship, this study aimed to carry out an investigation on online intervention features for effective management of Facebook addiction in higher education. Methods: This study was conducted quantitatively using surveys and partial least square-structural equational modeling. The study involved 200 postgraduates in a Facebook support group for postgraduates. The Bergen Facebook Addiction test was used to assess postgraduates’ Facebook addiction level, whereas online intervention features were used to assess postgraduates’ perceptions of online intervention features for Facebook addiction, which are as follows: (1) self-monitoring features, (2) manual control features, (3) notification features, (4) automatic control features, and (5) reward features. Results: The study discovered six Facebook addiction factors (relapse, conflict, salience, tolerance, withdrawal, and mood modification) and five intervention features (notification, auto-control, reward, manual control, and self-monitoring) that could be used in the management of Facebook addiction in postgraduate education. The study also revealed that relapse is the most important factor and mood modification is the least important factor. Furthermore, findings indicated that notification was the most important intervention feature, whereas self-monitoring was the least important feature. Conclusions: The study’s findings (addiction factors and intervention features) could assist future developers and educators in the development of online intervention tools for Facebook addiction management in postgraduate education. %M 31579018 %R 10.2196/14834 %U https://www.jmir.org/2019/10/e14834 %U https://doi.org/10.2196/14834 %U http://www.ncbi.nlm.nih.gov/pubmed/31579018 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 10 %P e14240 %T Diminishing Effects After Recurrent Use of Self-Guided Internet-Based Interventions in Depression: Randomized Controlled Trial %A Bücker,Lara %A Schnakenberg,Patricia %A Karyotaki,Eirini %A Moritz,Steffen %A Westermann,Stefan %+ Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistr 52, Hamburg, 20246, Germany, 49 40 7410 55868, l.buecker@uke.de %K eHealth %K self-management %K depressive symptoms %K randomized controlled trial %D 2019 %7 2.10.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Self-guided internet-based interventions have several advantages over guided interventions and are generally effective in treating psychiatric symptoms. Objective: We aimed to investigate whether the use of a new self-guided internet-based intervention (MOOD) would lead to a significant reduction in depressive symptoms compared with a care-as-usual (CAU) control group in a sample of individuals with depressive symptoms, most of whom had already used a different self-guided internet-based intervention in a previous trial. Methods: A total of 125 individuals were randomized to the intervention condition (MOOD) and received access to the intervention for a period of six weeks or a CAU group. After six weeks, all participants were invited to take part in the post assessment. The Beck Depression Inventory-II served as the primary outcome. Results: Both intention-to-treat as well as per-protocol analyses indicated that the depressive symptomatology decreased in both conditions but showed no advantage for those who had used MOOD. Subsequent moderation analyses suggested that those individuals who had less experience with psychotherapy benefitted to a greater extent compared with those with more experience. Conclusions: Self-guided internet-based interventions are deemed a suitable first-step approach to the treatment of depression. However, our results indicate that they are more efficacious in those with less psychotherapy experience. Trial Registration: ClinicalTrials.gov NCT03795480; http://clinicaltrials.gov/ct2/show/NCT03795480 %M 31579014 %R 10.2196/14240 %U https://www.jmir.org/2019/10/e14240 %U https://doi.org/10.2196/14240 %U http://www.ncbi.nlm.nih.gov/pubmed/31579014 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 10 %P e14407 %T Tailored Web-Based Information for Younger and Older Patients with Cancer: Randomized Controlled Trial of a Preparatory Educational Intervention on Patient Outcomes %A Nguyen,Minh Hao %A Smets,Ellen M A %A Bol,Nadine %A Loos,Eugène F %A van Laarhoven,Hanneke W M %A Geijsen,Debby %A van Berge Henegouwen,Mark I %A Tytgat,Kristien M A J %A van Weert,Julia C M %+ Amsterdam School of Communication Research, University of Amsterdam, Nieuwe Achtergracht 166, 1018 WV, Amsterdam, Netherlands, 31 20 525 368, mh.nguyen@ikmz.uzh.ch %K Web-based tailoring %K internet %K audiovisual media %K patient education %K cancer %K aging %K memory %K anxiety %K patient reported outcomes %K patient participation %K consultation %K health communication %K randomized controlled trial %D 2019 %7 1.10.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Many patients with cancer, including older patients (aged ≥65 years), consult the Web to prepare for their doctor’s visit. In particular, older patients have varying needs regarding the mode in which information is presented (eg, via textual, visual, or audiovisual modes) owing to age-related sensory (eg, impaired vision and hearing) and cognitive decline (eg, reduced processing speed). Therefore, Web-based information targeted at older patient populations is likely to be used and processed more effectively, and evaluated more positively, when tailored to age-related capabilities and preferences. This, in turn, may benefit patient outcomes. Objective: This randomized controlled trial tested the effects of a Web-based tailored educational intervention among newly diagnosed younger (<65 years) and older (≥65 years) patients with cancer. We compared the intervention group who viewed a mode-tailored website (ie, enabling patients to tailor information using textual, visual, and audiovisual modes) with 3 control groups view a nontailored website (ie, text only, text with images, and text with videos). We examined website experience outcomes (ie, website satisfaction, website involvement, knowledge, anxiety, and communication self-efficacy) and consultation experience outcomes (ie, question asking during consultation, anxiety, and information recall). Methods: Patients from a multidisciplinary outpatient clinic (N=232) viewed a mode-tailored or nontailored website as preparation before their hospital consultations to discuss diagnosis and treatment. Data were collected before (T1), during (T2), and after (T3) visitation. Website experience outcomes were assessed with questionnaires (T1). Patients’ question asking was coded from videotaped consultations, and anxiety was assessed through a questionnaire (T2). Telephone interviews were conducted to assess knowledge acquired from the website before (T1) and after consultation (T3), and information recall from the consultation (T3). Results: The preparatory website was well used across all conditions (mean 34 min). Younger patients viewing the mode-tailored website were more satisfied before consultation (P=.02) and reported lower anxiety after consultation (P=.046; vs text only). This pattern was not found in older patients. Mode tailoring yielded no other significant differences in patient outcomes. Regression analyses showed that website involvement (beta=.15; P=.03) and, to a lesser extent, website satisfaction (beta=.15; P=.05) positively associated with knowledge before consultation (T1). In turn, higher knowledge before consultation (beta=.39; P<.001), together with time on the website (beta=.21; P=.002; T1), predicted information recall from consultations (T3). Patients with higher knowledge before consultation (T1) also reported higher knowledge from the website afterward (T3; beta=.22; P=.003). Conclusions: Offering preparatory online information before consultations benefits information processing and patient outcomes of both younger and older newly diagnosed patients with cancer. Younger patients benefit even more when information is offered in a mode-tailored manner. We discuss the theoretical, methodological, and practical implications for patient-provider communication research in an electronic health era. Clinical Trial: Netherlands Trial Register NTR5904; https://www.trialregister.nl/trial/5750 %M 31573911 %R 10.2196/14407 %U https://www.jmir.org/2019/10/e14407 %U https://doi.org/10.2196/14407 %U http://www.ncbi.nlm.nih.gov/pubmed/31573911 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 9 %P e13947 %T Information and Communication Systems to Tackle Barriers to Breastfeeding: Systematic Search and Review %A Tang,Kymeng %A Gerling,Kathrin %A Chen,Wei %A Geurts,Luc %+ e-Media Research Lab, KU Leuven, Andreas Vesaliusstraat 13, Leuven, 3000, Belgium, 32 16 32 24 97, kymeng.tang@kuleuven.be %K breastfeeding %K technology %K review %D 2019 %7 27.9.2019 %9 Review %J J Med Internet Res %G English %X Background: Breastfeeding has many benefits for newborns, mothers, and the wider society. The World Health Organization recommends mothers to feed newborns exclusively with breastmilk for the first 6 months after birth, but breastfeeding rates in many countries fail to align with the recommendations because of various barriers. Breastfeeding success is associated with a number of determinants, such as self-efficacy, intention to breastfeed, and attitudes toward breastfeeding. Information and communication technology (ICT) has been leveraged to support breastfeeding by means of improving knowledge or providing practical supports in different maternal stages. Previous reviews have examined and summarized the effectiveness and credibility of interventions; however, no review has been done from a human-computer interaction perspective that is concerned with novel interaction techniques and the perspective of end users. Objective: The objective of this review was to provide a comprehensive overview of existing digital interventions that support breastfeeding by investigating systems’ objective, technology design, validation process, and quality attributes, both in terms of clinical parameters as well as usability and user experience. Methods: A systematic search was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines in the following libraries: PubMed, Science Direct, Association for Computing Machinery Digital Library (ACM Digital Library), and Institute of Electrical and Electronics Engineers Xplore (IEEE Xplore). Results: A total of 35 papers discussing 30 interventions were included. The main goals of these interventions were organized into 4 categories: breastfeeding education (n=12), breastfeeding promotion (n=8), communication support (n=6), and daily practical support (n=4). Of the interventions, 13 target mothers in the postnatal period. Most interventions come in forms of client communication systems (n=18), which frequently leverage Web technologies, text message, and mobile apps to provide breastfeeding support. Systems predominantly focus on mothers; validation strategies were rather heterogeneous, with 12 user studies concerning usability and user experience and 18 clinical validation studies focusing on the effects of the interventions on breastfeeding determinants; 5 papers did not report results. Generally, straightforward systems (eg, communication tools or Web-based solutions) seem to be more effective than complex interventions (eg, games). Conclusions: Existing information and communication systems offer effective means of improving breastfeeding outcomes, but they do not address all relevant periods in parenthood (eg, the antenatal period) and often do not involve important stakeholders, such as partners. There is an opportunity to leverage more complex technical systems to open up avenues for the broader design of ICT to support breastfeeding; however, considering evaluation outcomes of existing support systems of higher complexity, such systems need to be designed with care. %M 31573903 %R 10.2196/13947 %U https://www.jmir.org/2019/9/e13947/ %U https://doi.org/10.2196/13947 %U http://www.ncbi.nlm.nih.gov/pubmed/31573903 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 9 %P e12137 %T Comparing the Efficacy of an Identical, Tailored Smoking Cessation Intervention Delivered by Mobile Text Messaging Versus Email: Randomized Controlled Trial %A Gram,Inger Torhild %A Larbi,Dillys %A Wangberg,Silje Camilla %+ Norwegian Centre for E-health Research, University Hospital of North Norway, SIVA Innovation Centre Tromsø, Sykehusvn 23, Tromsø, 9038, Norway, 47 92401177, inger.gram@ehealthresearch.no %K eHealth %K electronic mail %K mHealth %K mobile phones %K randomized controlled trial %K smoking cessation %K text-messaging %D 2019 %7 27.9.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: There is a need to deliver smoking cessation support at a population level, both in developed and developing countries. Studies on internet-based and mobile phone–based smoking cessation interventions have shown that these methods can be as effective as other methods of support, and they can have a wider reach at a lower cost. Objective: This randomized controlled trial (RCT) aimed to compare, on a population level, the efficacy of an identical, tailored smoking cessation intervention delivered by mobile text messaging versus email. Methods: We conducted a nationwide 2-arm, double-blinded, fully automated RCT, close to a real-world setting, in Norway. We did not offer incentives to increase participation and adherence or to decrease loss to follow-up. We recruited users of the website, slutta.no, an open, free, multi-component Norwegian internet-based smoking cessation program, from May 2010 until October 2012. Enrolled smokers were considered as having completed a time point regardless of their response status if it was 1, 3, 6, or 12 months post cessation. We assessed 7315 participants using the following inclusion criteria: knowledge of the Norwegian language, age 16 years or older, ownership of a Norwegian cell phone, having an email account, current cigarette smoker, willingness to set a cessation date within 14 days (mandatory), and completion of a baseline questionnaire for tailoring algorithms. Altogether, 6137 participants were eligible for the study and 4378 participants (71.33%) provided informed consent to participate in the smoking cessation trial. We calculated the response rates for participants at the completed 1, 3, 6, and 12 months post cessation. For each arm, we conducted an intention-to-treat (ITT) analysis for each completed time point. The main outcome was 7-day self-reported point prevalence abstinence (PPA) at the completed 6 months post cessation. We calculated effect size of the 7-day self-reported PPA in the text message arm compared with the email arm as odds ratios (ORs) with 95% CIs for the 4 time points post cessation. Results: At 6 months follow-up, 21.06% (384/1823) of participants in the text message arm and 18.62% (333/1788) in the email arm responded (P=.07) to the surveys. In the ITT analysis, 11.46% (209/1823) of participants in the text message arm compared with 10.96% (196/1788) in the email arm (OR 1.05, 95% CI 0.86-1.30) reported to have achieved 7 days PPA. Conclusions: This nationwide, double-blinded, large, fully automated RCT found that 1 in 9 enrolled smokers reported 7-day PPA in both arms, 6 months post cessation. Our study found that identical smoking cessation interventions delivered by mobile text messaging and email may be equally successful at a population level. Trial Registration: ClinicalTrials.gov NCT01103427; https://clinicaltrials.gov/ct2/show/NCT01103427 %M 31573935 %R 10.2196/12137 %U https://mhealth.jmir.org/2019/9/e12137 %U https://doi.org/10.2196/12137 %U http://www.ncbi.nlm.nih.gov/pubmed/31573935 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 9 %P e12500 %T A Web-Based Photo-Alteration Intervention to Promote Sleep: Randomized Controlled Trial %A Perucho,Isabel %A Vijayakumar,Kamalakannan M %A Talamas,Sean N %A Chee,Michael Wei-Liang %A Perrett,David I %A Liu,Jean C J %+ Division of Social Sciences, Yale-NUS College, 16 College Ave West #02-221, Singapore, 138527, Singapore, 65 66013694, jeanliu@yale-nus.edu.sg %K sleep %K public health %K physical appearance %K outward appearance %D 2019 %7 26.9.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Receiving insufficient sleep has wide-ranging consequences for health and well-being. Although educational programs have been developed to promote sleep, these have had limited success in extending sleep duration. To address this gap, we developed a Web-based program emphasizing how physical appearances change with varying amounts of sleep. Objective: The aims of this study were to evaluate (1) whether participants can detect changes in appearances as a function of sleep and (2) whether this intervention can alter habitual sleep patterns. Methods: We conducted a 5-week, parallel-group, randomized controlled trial among 70 habitual short sleepers (healthy adults who reported having <7 hours of sleep routinely). Upon study enrollment, participants were randomly assigned (1:1) to receive either standard information or an appearance-based intervention. Both groups received educational materials about sleep, but those in the appearance group also viewed a website containing digitally edited photographs that showed how they would look with varying amounts of sleep. As the outcome variables, sleep duration was monitored objectively via actigraphy (at baseline and at postintervention weeks 1 and 4), and participants completed a measure of sleep hygiene (at baseline and at postintervention weeks 2, 4, and 5). For each outcome, we ran intention-to-treat analyses using linear mixed-effects models. Results: In total, 35 participants were assigned to each group. Validating the intervention, participants in the appearance group (1) were able to identify what they looked like at baseline and (2) judged that they would look more attractive with a longer sleep duration (t26=10.35, P<.001). In turn, this translated to changes in sleep hygiene. Whereas participants in the appearance group showed improvements following the intervention (F1,107.99=9.05, P=.003), those in the information group did not (F1,84.7=0.19, P=.66). Finally, there was no significant effect of group nor interaction of group and time on actigraphy-measured sleep duration (smallest P=.26). Conclusions: Our findings suggest that an appearance-based intervention, while not sufficient as a stand-alone, could have an adjunctive role in sleep promotion. Trial Registration: ClinicalTrials.gov NCT02491138; https://clinicaltrials.gov/ct2/show/study/NCT02491138. %M 31573913 %R 10.2196/12500 %U https://www.jmir.org/2019/9/e12500 %U https://doi.org/10.2196/12500 %U http://www.ncbi.nlm.nih.gov/pubmed/31573913 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 9 %P e15011 %T An Internet-Based Self-Help Intervention for Skin Picking (SaveMySkin): Pilot Randomized Controlled Trial %A Gallinat,Christina %A Moessner,Markus %A Haenssle,Holger A %A Winkler,Julia K %A Backenstrass,Matthias %A Bauer,Stephanie %+ Center for Psychotherapy Research, University Hospital Heidelberg, Bergheimer Str 54, Heidelberg, Germany, 49 6221567381, christina.gallinat@med.uni-heidelberg.de %K skin picking %K excoriation disorder %K dermatillomania %K internet-based %K self-help %K cognitive-behavioral therapy %D 2019 %7 20.09.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: In spite of the psychosocial burden and medical risks associated with skin picking disorder, the health care system does not provide sufficient treatment for affected individuals to date. Therefore, an internet-based self-help program for skin picking was developed to offer easily accessible support for this population. Objective: This pilot study evaluated the internet-based self-help program SaveMySkin. The 12-week program is based on cognitive-behavioral therapy and contains comprehensive information and exercises, a daily supportive monitoring system, and dermatological and psychological counseling via internet chat. Primary objectives were the investigation of attitudes and expectations toward the program, intervention effects on skin picking severity, user satisfaction, adherence, and willingness to participate. Secondary outcomes included the feasibility of study procedures, adequacy of assessment instruments, effects on skin picking–related impairment, dimensions of skin picking, and general psychological impairment. Methods: A two-arm randomized controlled trial was conducted in a sample of 133 participants (female: 124/133, 93.2%; mean age 26.67 [SD 6.42]) recruited via the internet. Inclusion required a minimum age of 17 years and at least mild skin picking severity. Participants were randomly allocated to the intervention (64/133, 48.1%) or waitlist control group (69/133, 51.9%). All assessments were conducted online and based on self-report. Results: The willingness to participate was very high in the study, so the initially planned sample size of 100 was exceeded after only 18 days. Participant expectations indicate that they believed the program to be beneficial for them (131/133, 98.5%) and provide a feeling of support (119/133, 89.5%). Reasons for study participation were insufficient outpatient health care (83/133, 62.4%) and flexibility regarding time (106/133, 79.7%) and location (109/133, 82.0%). The post-assessment was completed by 65.4% (87/133) of the sample. The majority of the intervention group who completed the entire post-assessment were satisfied with SaveMySkin (28/38, 74%) and agreed that the program is an appropriate support service (35/38, 92%). On average, participants viewed 29.31 (SD 42.02) pages in the program, and 47% (30/64) of the intervention group used the monitoring at least once a week. In comparison with the control group, the intervention group displayed substantial improvements in the skin picking severity total score (Cohen d=0.67) and especially on the subscale Symptom Severity (Cohen d=0.79). No effects on secondary outcomes were found. Conclusions: This study confirms the need for easily accessible interventions for skin picking disorder and the high interest in internet-based self-help within the target population. It provides important insights into the attitudes toward online support and actual user experiences. Participant feedback will be used to further enhance the intervention. Our results point to the preliminary efficacy of SaveMySkin and may lay the foundation for future research into the efficacy and cost-effectiveness of the program in a multicenter clinical trial. Trial Registration: German Clinical Trial Register DRKS00015236; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00015236 International Registered Report Identifier (IRRID): RR2-10.1016/j.conctc.2018.100315 %M 31586368 %R 10.2196/15011 %U https://www.jmir.org/2019/9/e15011 %U https://doi.org/10.2196/15011 %U http://www.ncbi.nlm.nih.gov/pubmed/31586368 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 9 %P e15318 %T Using Relational Agents to Promote Family Communication Around Type 1 Diabetes Self-Management in the Diabetes Family Teamwork Online Intervention: Longitudinal Pilot Study %A Thompson,Debbe %A Callender,Chishinga %A Gonynor,Caroline %A Cullen,Karen W %A Redondo,Maria J %A Butler,Ashley %A Anderson,Barbara J %+ United States Department of Agriculture/Agricultural Research Service Children's Nutrition Research Center, Baylor College of Medicine, 1100 Bates St, Houston, TX, 77030, United States, 1 713 798 7076, dit@bcm.edu %K adolescents %K family communication %K preadolescents %K relational agent %K type 1 diabetes %D 2019 %7 13.09.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Family conflict can reduce adolescent adherence to type 1 diabetes management tasks. The Family Teamwork in-person intervention was shown to be efficacious in reducing conflict and low adherence to diabetes-related tasks. Its reach and potential impact, however, were limited by the need to deliver the intervention sessions in person. Relational agents (ie, computerized versions of humans) have been shown to appeal to diverse audiences and may be an acceptable replacement for a human in technology-based behavior change interventions. Objective: The purpose of this paper is to present the results of a pilot study assessing feasibility and acceptability of Diabetes Family Teamwork Online, an adapted version of the Family Teamwork intervention, delivered over the internet and guided by a relational agent. Methods: Parent-adolescent dyads were recruited through a diabetes care clinic at a large tertiary care hospital in the southwestern United States. A one-group design, with assessments at baseline, immediate postintervention, and 3 months later, was used to assess feasibility. A priori feasibility criteria included an assessment of recruitment, completion, attrition, program satisfaction, therapeutic alliance, attitudes toward the relational agent, and data collection. The institutional review board at Baylor College of Medicine approved the protocol (H-37245). Results: Twenty-seven adolescents aged 10 to 15 years with type 1 diabetes and their parents were enrolled. Criteria used to assess feasibility were (1) recruitment goals were met (n=20), (2) families completed ≥75% of the modules, (3) attrition rate was ≤10%, (4) program satisfaction was high (≥80% of families), (5) therapeutic alliance was high (average score of ≥60/84), (6) families expressed positive attitudes toward the relational agent (average item score of ≥5 on ≥4 items), (7) ≥80% of data were collected at post 1 and post 2, and (8) few technical issues (≤10%) occurred during intervention delivery. All feasibility criteria were met. Qualitative data confirmed that adolescents and parents had positive reactions to both the content and approach. Conclusions: The Diabetes Family Teamwork Online intervention proved to be a feasible and acceptable method for enhancing communication around diabetes management tasks in families with an adolescent who has type 1 diabetes. International Registered Report Identifier (IRRID): RR2-10.2196/resprot.5817 %M 31538940 %R 10.2196/15318 %U https://www.jmir.org/2019/9/e15318/ %U https://doi.org/10.2196/15318 %U http://www.ncbi.nlm.nih.gov/pubmed/31538940 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 9 %P e11759 %T Tailoring Persuasive Electronic Health Strategies for Older Adults on the Basis of Personal Motivation: Web-Based Survey Study %A van Velsen,Lex %A Broekhuis,Marijke %A Jansen-Kosterink,Stephanie %A op den Akker,Harm %+ eHealth Group, Roessingh Research and Development, PO Box 310, Enschede, 7500 AH, Netherlands, 31 0880875754, l.vanvelsen@rrd.nl %K persuasive communication %K health communication %K software design %D 2019 %7 06.09.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Persuasive design, in which the aim is to change attitudes and behaviors by means of technology, is an important aspect of electronic health (eHealth) design. However, selecting the right persuasive feature for an individual is a delicate task and is likely to depend on individual characteristics. Personalization of the persuasive strategy in an eHealth intervention therefore seems to be a promising approach. Objective: This study aimed to develop a method that allows us to model motivation in older adults with respect to leading a healthy life and a strategy for personalizing the persuasive strategy of an eHealth intervention, based on this user model. Methods: We deployed a Web-based survey among older adults (aged >60 years) in the Netherlands. In the first part, we administered an adapted version of the revised Sports Motivation Scale (SMS-II) as input for the user models. Then, we provided each participant with a selection of 5 randomly chosen mock-ups (out of a total of 11), each depicting a different persuasive strategy. After showing each strategy, we asked participants how much they appreciated it. The survey was concluded by addressing demographics. Results: A total of 212 older adults completed the Web-based survey, with a mean age of 68.35 years (SD 5.27 years). Of 212 adults, 45.3% were males (96/212) and 54.7% were female (116/212). Factor analysis did not allow us to replicate the 5-factor structure for motivation, as targeted by the SMS-II. Instead, a 3-factor structure emerged with a total explained variance of 62.79%. These 3 factors are intrinsic motivation, acting to derive satisfaction from the behavior itself (5 items; Cronbach alpha=.90); external regulation, acting because of externally controlled rewards or punishments (4 items; Cronbach alpha=.83); and a-motivation, a situation where there is a lack of intention to act (2 items; r=0.50; P<.001). Persuasive strategies were appreciated differently, depending on the type of personal motivation. In some cases, demographics played a role. Conclusions: The personal type of motivation of older adults (intrinsic, externally regulated, and/or a-motivation), combined with their educational level or living situation, affects an individual’s like or dislike for a persuasive eHealth feature. We provide a practical approach for profiling older adults as well as an overview of which persuasive features should or should not be provided to each profile. Future research should take into account the coexistence of multiple types of motivation within an individual and the presence of a-motivation. %M 31493323 %R 10.2196/11759 %U https://www.jmir.org/2019/9/e11759 %U https://doi.org/10.2196/11759 %U http://www.ncbi.nlm.nih.gov/pubmed/31493323 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 9 %P e14967 %T A Digital Intervention Addressing Alcohol Use Problems (the “Daybreak” Program): Quasi-Experimental Randomized Controlled Trial %A Tait,Robert J %A Paz Castro,Raquel %A Kirkman,Jessica Jane Louise %A Moore,Jamie Christopher %A Schaub,Michael P %+ National Drug Research Institute, Faculty of Health Sciences, Curtin University, GPO Box U 1981, Perth, 6845, Australia, 61 892661610, robert.tait@curtin.edu.au %K alcohol consumption %K internet %K digital health %K intervention study %K social marketing %K health promotion %D 2019 %7 04.09.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Alcohol use is prevalent in many societies and has major adverse impacts on health, but the availability of effective interventions limits treatment options for those who want assistance in changing their patterns of alcohol use. Objective: This study evaluated the new Daybreak program, which is accessible via mobile app and desktop and was developed by Hello Sunday Morning to support high-risk drinking individuals looking to change their relationship with alcohol. In particular, we compared the effect of adding online coaching via real-time chat messages (intervention group) to an otherwise self-guided program (control group). Methods: We designed the intervention as a randomized control trial, but as some people (n=48; 11.9%) in the control group were able to use the online coaching, the main analysis comprised all participants. We collected online surveys at one-month and three-months follow-up. The primary outcome was change in alcohol risk (measured with the alcohol use disorders identification test–consumption [AUDIT–C] score), but other outcomes included the number of standard drinks per week, alcohol-related days out of role, psychological distress (Kessler-10), and quality of life (EUROHIS-QOL). Markers of engagement with the program included posts to the site and comments on the posts of others. The primary analysis used Weighted Generalized Estimating Equations. Results: We recruited 398 people to the intervention group (50.2%) and 395 people to the control group (49.8%). Most were female (71%) and the mean age was 40.1 years. Most participants were classified as probably dependent (550, 69%) on the AUDIT–10, with 243 (31%) classified with hazardous or harmful consumption. We followed up with 334 (42.1%) participants at one month and 293 (36.9%) at three months. By three months there were significant improvements in AUDIT–C scores (down from mean 9.1 [SD 1.9] to 5.8 [SD 3.1]), alcohol consumed per week (down from mean 37.1 [SD 28.3] to mean 17.5 [SD 18.9]), days out of role (down from mean 1.6 [SD 3.6] to 0.5 [SD 1.6]), quality of life (up from 3.2 [SD 0.7] to 3.6 [SD 0.7]) and reduced distress (down from 24.8 [SD 7.0] to 19.0 [SD 6.6]). Accessing online coaching was not associated with improved outcomes, but engagement with the program (eg, posts and comments on the posts of others) were significantly associated with improvements (eg, in AUDIT–C, alcohol use and EUROHIS-QOL). Reduced alcohol use was found for both probably dependent (estimated marginal mean of 40.8 to 20.1 drinks) and hazardous or harmful alcohol users (estimated marginal mean of 22.9 to 11.9 drinks). Conclusions: Clinically significant reductions in alcohol use were found, as well as reduced alcohol risk (AUDIT–C) and days out of role. Importantly, improved alcohol-related outcomes were found for both hazardous or harmful and probably dependent drinkers. Since October 2016, Daybreak has reached more than 50,000 participants. Therefore, there is the potential for the program to have an impact on alcohol-related problems at a population health level, importantly including an effect on probably dependent drinkers. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12618000010291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373110 International Registered Report Identifier (IRRID): RR2-10.2196/9982 %M 31486406 %R 10.2196/14967 %U https://www.jmir.org/2019/9/e14967/ %U https://doi.org/10.2196/14967 %U http://www.ncbi.nlm.nih.gov/pubmed/31486406 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 8 %P e14305 %T The Effect of the Interactive Mobile Health and Rehabilitation System on Health and Psychosocial Outcomes in Spinal Cord Injury: Randomized Controlled Trial %A Kryger,Michael Alan %A Crytzer,Theresa M %A Fairman,Andrea %A Quinby,Eleanor J %A Karavolis,Meredith %A Pramana,Gede %A Setiawan,I Made Agus %A McKernan,Gina Pugliano %A Parmanto,Bambang %A Dicianno,Brad E %+ Department of Physical Medicine and Rehabilitation, University of Pittsburgh, 6425 Penn Ave, Suite 400, Office 4115, Pittsburgh, PA, 15206, United States, 1 412 822 3700, dicianno@pitt.edu %K cellular phone %K emergency departments %K hospitalization %K mobile applications %K pressure ulcer %K rehabilitation %K self-care %K spinal cord injury %K telemedicine %K urinary tract infections %D 2019 %7 28.08.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Individuals with spinal cord injury (SCI) are at risk for secondary medical complications, such as urinary tract infections (UTIs) and pressure injuries, that could potentially be mitigated through improved self-management techniques. The Interactive Mobile Health and Rehabilitation (iMHere) mobile health (mHealth) system was developed to support self-management for individuals with disabilities. Objective: The main objective of this study was to determine if the use of iMHere would be associated with improved health outcomes over a 9-month period. A secondary objective was to determine if the use of iMHere would be associated with improved psychosocial outcomes. Phone usage, app usage, and training time data were also collected to analyze trends in iMHere use. Methods: Overall, 38 participants with SCI were randomized into either the intervention group who used the iMHere system and received standard care or the control group who received standard care without any technology intervention. Health outcomes were recorded for the year before entry into the study and during the 9 months of the study. Participants completed surveys at baseline and every 3 months to measure psychosocial outcomes. Results: The intervention group had a statistically significant reduction in UTIs (0.47 events per person; P=.03; number needed to treat=2.11). Although no psychosocial outcomes changed significantly, there was a nonsignificant trend toward a reduction in mood symptoms in the intervention group compared with the control group meeting the threshold for clinical significance. Approximately 34 min per participant per month were needed on average to manage the system and provide technical support through this mHealth system. Conclusions: The use of the iMHere mHealth system may be a valuable tool in the prevention of UTIs or reductions in depressive symptoms. Given these findings, iMHere has potential scalability for larger populations. Trial Registration: ClinicalTrials.gov NCT02592291; https://clinicaltrials.gov/ct2/show/NCT02592291. %M 31464189 %R 10.2196/14305 %U http://www.jmir.org/2019/8/e14305/ %U https://doi.org/10.2196/14305 %U http://www.ncbi.nlm.nih.gov/pubmed/31464189 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 8 %P e10963 %T The Association Between Web-Based or Face-to-Face Lifestyle Interventions on the Perceived Benefits and Barriers to Exercise in Midlife Women: Three-Arm Equivalency Study %A McGuire,Amanda Mary %A Seib,Charrlotte %A Porter-Steele,Janine %A Anderson,Debra Jane %+ Menzies Health Institute Queensland, Griffith University, Parklands Drive, Southport, 4215, Australia, 61 7 5552 8860, a.mcguire@griffith.edu.au %K exercise %K physical activity %K women %K health behavior %K behavioral medicine %K health promotion %K digital health %K benefits and barriers %D 2019 %7 21.08.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Noncommunicable diseases pose a significant threat to women’s health globally, with most diseases being attributed to modifiable risk factors such as physical inactivity. Women perceive a range of benefits and barriers to exercise; however, there is little evidence about the effect of different lifestyle intervention delivery modes on perceptions of exercise. Objective: This study aimed to compare the effect of a multiple health behavior change (MHBC) intervention called the Women’s Wellness Program. This intervention was delivered in 3 different modes on perceived exercise benefits, perceived exercise barriers, and actual physical activity and exercise in midlife women. Methods: Women aged 45 to 65 years were recruited via the study website. They were assigned in blocks to 3 different treatment groups (A: Web-based independent; B: face-to-face with nurse consultations; and C: Web-based with virtual nurse consultations). All participants received the 12-week intervention that utilizes principles from social-cognitive theory to provide a structured guide to promote healthy lifestyle behaviors with an emphasis on regular exercise and healthy eating. Data were collected using a self-report Web-based questionnaire at baseline (T1) and postintervention (T2) including perceived exercise benefits and barriers and exercise and physical activity. A data analysis examined both within- and between-group changes over time. Results: Participants in this study (N=225) had a mean age of 50.9 years (SD 5.9) and most were married or living with a partner (83.3%, 185/225). Attrition was 30.2% with 157 participants completing the final questionnaire. Women in all intervention groups reported a significant increase in positive perceptions of exercise (P<.05); a significant increase in exercise and overall physical activity (P<.01) with moderate-to-large effect sizes noted for overall physical activity (d=0.5 to d=0.87). Participants receiving support from registered nurses in the face-to-face and Web-based groups had a greater magnitude of change in benefit perceptions and physical activity than those in the Web-based independent group. There was no significant change in exercise barrier perceptions within or between groups over time. Conclusions: The results of this study suggest that the (MHBC) intervention is effective in increasing exercise benefit perceptions, overall physical activity, and exercise in midlife women. Although Web-based programs are cost-effective and flexible and can be delivered remotely, providing a range of options including face-to-face group delivery and personalized electronic health coaching from registered nurses has the potential to enhance participant engagement and motivation. %M 31436162 %R 10.2196/10963 %U https://www.jmir.org/2019/8/e10963/ %U https://doi.org/10.2196/10963 %U http://www.ncbi.nlm.nih.gov/pubmed/31436162 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 8 %P e14630 %T Digital Health Apps in the Clinical Care of Inflammatory Bowel Disease: Scoping Review %A Yin,Andrew Lukas %A Hachuel,David %A Pollak,John P %A Scherl,Ellen J %A Estrin,Deborah %+ Medical College, Weill Cornell Medicine, 1300 York Avenue, New York, NY,, United States, 1 212 746 1067, aly2011@med.cornell.edu %K digital health %K mHealth %K mobile health %K mobile technology %K smartphone %K eHealth %K review %K inflammatory bowel disease %K Crohn’s disease %K ulcerative colitis %D 2019 %7 19.08.2019 %9 Review %J J Med Internet Res %G English %X Background: Digital health is poised to transform health care and redefine personalized health. As Internet and mobile phone usage increases, as technology develops new ways to collect data, and as clinical guidelines change, all areas of medicine face new challenges and opportunities. Inflammatory bowel disease (IBD) is one of many chronic diseases that may benefit from these advances in digital health. This review intends to lay a foundation for clinicians and technologists to understand future directions and opportunities together. Objective: This review covers mobile health apps that have been used in IBD, how they have fit into a clinical care framework, and the challenges that clinicians and technologists face in approaching future opportunities. Methods: We searched PubMed, Scopus, and ClinicalTrials.gov to identify mobile apps that have been studied and were published in the literature from January 1, 2010, to April 19, 2019. The search terms were (“mobile health” OR “eHealth” OR “digital health” OR “smart phone” OR “mobile app” OR “mobile applications” OR “mHealth” OR “smartphones”) AND (“IBD” OR “Inflammatory bowel disease” OR “Crohn's Disease” (CD) OR “Ulcerative Colitis” (UC) OR “UC” OR “CD”), followed by further analysis of citations from the results. We searched the Apple iTunes app store to identify a limited selection of commercial apps to include for discussion. Results: A total of 68 articles met the inclusion criteria. A total of 11 digital health apps were identified in the literature and 4 commercial apps were selected to be described in this review. While most apps have some educational component, the majority of apps focus on eliciting patient-reported outcomes related to disease activity, and a few are for treatment management. Significant benefits have been seen in trials relating to education, quality of life, quality of care, treatment adherence, and medication management. No studies have reported a negative impact on any of the above. There are mixed results in terms of effects on office visits and follow-up. Conclusions: While studies have shown that digital health can fit into, complement, and improve the standard clinical care of patients with IBD, there is a need for further validation and improvement, from both a clinical and patient perspective. Exploring new research methods, like microrandomized trials, may allow for more implementation of technology and rapid advancement of knowledge. New technologies that can objectively and seamlessly capture remote data, as well as complement the clinical shift from symptom-based to inflammation-based care, will help the clinical and health technology communities to understand the full potential of digital health in the care of IBD and other chronic illnesses. %M 31429410 %R 10.2196/14630 %U http://www.jmir.org/2019/8/e14630/ %U https://doi.org/10.2196/14630 %U http://www.ncbi.nlm.nih.gov/pubmed/31429410 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 8 %P e13628 %T Medium-Term Effects of a Tailored Web-Based Parenting Intervention to Reduce Adolescent Risk of Depression and Anxiety: 12-Month Findings From a Randomized Controlled Trial %A Yap,Marie Bee Hui %A Cardamone-Breen,Mairead C %A Rapee,Ronald M %A Lawrence,Katherine A %A Mackinnon,Andrew J %A Mahtani,Shireen %A Jorm,Anthony F %+ School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, 18 Innovation Walk, Wellington Road, Clayton, Melbourne, 3168, Australia, 61 0399051250, marie.yap@monash.edu %K family %K parenting %K mental health %K depression %K anxiety %K adolescent %K internet %K randomized controlled trial %K preventive health services %D 2019 %7 15.08.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Prevention of depression and anxiety disorders early in life is a global health priority. Evidence on risk and protective factors for youth internalizing disorders indicates that the family represents a strategic setting to target preventive efforts. Despite this evidence base, there is a lack of accessible, cost-effective preventive programs for parents of adolescents. To address this gap, we recently developed the Partners in Parenting (PiP) program—an individually tailored Web-based parenting program targeting evidence-based parenting risk and protective factors for adolescent depression and anxiety disorders. We previously reported the postintervention outcomes of a single-blinded parallel-group superiority randomized controlled trial (RCT) in which PiP was found to significantly improve self-reported parenting compared with an active-control condition (educational factsheets). Objective: This study aimed to evaluate the effects of the PiP program on parenting risk and protective factors and symptoms of adolescent depression and anxiety using data from the final assessment time point (12-month follow-up) of this RCT. Methods: Parents (n=359) and adolescents (n=332) were recruited primarily from secondary schools and completed Web-based assessments of parenting and adolescent depression and anxiety symptoms at baseline, postintervention (3 months later), and 12-month follow-up (317 parents, 287 adolescents). Parents in the PiP intervention condition received personalized feedback about their parenting and were recommended a series of up to 9 interactive modules. Control group parents received access to 5 educational factsheets about adolescent development and mental health. Both groups received a weekly 5-min phone call to encourage progress through their program. Results: Intervention group parents completed an average of 73.7% of their intended program. For the primary outcome of parent-reported parenting, the intervention group showed significantly greater improvement from baseline to 12-month follow-up compared with controls, with a medium effect size (Cohen d=0.51; 95% CI 0.30 to 0.72). When transformed data were used, greater reduction in parent-reported adolescent depressive symptoms was observed in the intervention group (Cohen d=−0.21; 95% CI −0.42 to −0.01). Mediation analyses revealed that these effects were mediated by improvements in parenting (indirect effect b=−0.08; 95% CI −0.16 to −0.01). No other significant intervention effects were found for adolescent-reported parenting or adolescent depression or anxiety symptoms. Both groups showed significant reductions in anxiety (both reporters) and depressive (parent reported) symptoms. Conclusions: PiP improved self-reported parenting for up to 9 months postintervention, but its effects on adolescent symptoms were less conclusive, and parent-reported changes were not perceived by adolescents. Nonetheless, given its scalability, PiP may be a useful low-cost, sustainable program to empower parents of adolescents. Trial Registration: Australian Clinical Trials Registration Number (ACTRN): 12615000328572; http://www.anzctr.org.au/ACTRN12615000328572.aspx (Archived by WebCite at http://www.webcitation.org/6qgsZ3Aqj). %M 31418422 %R 10.2196/13628 %U http://www.jmir.org/2019/8/e13628/ %U https://doi.org/10.2196/13628 %U http://www.ncbi.nlm.nih.gov/pubmed/31418422 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 8 %P e14374 %T A Multicomponent eHealth Intervention for Family Carers for People Affected by Psychosis: A Coproduced Design and Build Study %A Sin,Jacqueline %A Henderson,Claire %A Woodham,Luke A %A Sesé Hernández,Aurora %A Gillard,Steve %+ Population Health Research Institute, St George's, University of London, Cranmer Terrace, London, SW17 0RE, United Kingdom, 44 07817027036, jasin@sgul.ac.uk %K eHealth %K family caregivers %K psychosis %K mental health %K participatory research %K public and patient involvement %K coproduction %D 2019 %7 06.08.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Psychosis, including schizophrenia, is the most common severe mental illness affecting 1% of the population worldwide. A large number of people provide long-term support and care for a relative with psychosis. Although psychoeducational interventions, especially those delivered through a face-to-face group format, have an established evidence base for improving the caregiving experience, well-being, and health outcomes, large-scale implementation and access remain limited. There is a demand for such provision to be made through the internet for greater flexibility and wider access. Objective: This study aimed to integrate participatory research methodologies by the public, patients, and carers into the eHealth (electronic health) intervention design and build process to improve the product’s usability and acceptability. Methods: We adapted a structured eHealth intervention build method to include participatory research activities involving key stakeholders and end users to co-design and coproduce our intervention. An expert advisory group (EAG) comprising public involvement members led the formative design and build work using an agile build process. Carers independent from the study were consulted on the evolving drafts of the intervention prototype through focus group meetings. These results were fed back into the intervention build work continuously to ensure end users’ input inform every stage of the process. Results: An EAG comprising individuals with lived experience of psychosis, carers, health care professionals, researchers, voluntary organization workers, and eLearning experts (n=14) was established. A total of 4 coproduction workshops were held over 1 year during which the alpha and beta prototypes were designed and built through the participatory research work. Alongside this, 2 rounds of focus group study with carers (n=24, in 4 groups) were conducted to seek consultation on end users’ views and ideas to optimize the intervention design and usability. Finally, the EAG carried out a Web-based walk-through exercise on the intervention prototype and further refined it to make it ready for an online usability test. The final product contains multiple sections providing information on psychosis and related caregiving topics and interactive discussion forums with experts and peers for psychosocial support. It provides psychoeducation and psychosocial support for carers through the internet, promoting flexible access and individualized choices of information and support. Conclusions: The participatory research work led to the coproduction of a eHealth intervention called COPe-support (Carers fOr People with Psychosis e-support). We believe the study methodology, results, and output have optimized the intervention design and usability, fitting the end users’ needs and usage pattern. COPe-support is currently being tested for its effectiveness in promoting carers’ health outcome through an online randomized controlled trial. Trial Registration: ISRCTN Registry ISRCTN89563420; http://www.isrctn.com/ISRCTN89563420 %M 31389333 %R 10.2196/14374 %U https://www.jmir.org/2019/8/e14374/ %U https://doi.org/10.2196/14374 %U http://www.ncbi.nlm.nih.gov/pubmed/31389333 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 8 %P e13363 %T Efficacy of a Self-Regulation–Based Electronic and Mobile Health Intervention Targeting an Active Lifestyle in Adults Having Type 2 Diabetes and in Adults Aged 50 Years or Older: Two Randomized Controlled Trials %A Poppe,Louise %A De Bourdeaudhuij,Ilse %A Verloigne,Maïté %A Shadid,Samyah %A Van Cauwenberg,Jelle %A Compernolle,Sofie %A Crombez,Geert %+ Department of Movement and Sports Sciences, Ghent University, Watersportlaan 2, Ghent,, Belgium, 32 9 264 63 63, louise.poppe@ugent.be %K eHealth %K mHealth %K physical activity %K type 2 diabetes %K self-regulation %D 2019 %7 02.08.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Adopting an active lifestyle plays a key role in the prevention and management of chronic diseases such as type 2 diabetes mellitus (T2DM). Web-based interventions are able to alter health behaviors and show stronger effects when they are informed by a behavior change theory. MyPlan 2.0 is a fully automated electronic health (eHealth) and mobile health (mHealth) intervention targeting physical activity (PA) and sedentary behavior (SB) based on the Health Action Process Approach (HAPA). Objective: This study aimed to test the short-term effect of MyPlan 2.0 in altering levels of PA and SB and in changing personal determinants of behavior in adults with T2DM and in adults aged ≥50 years. Methods: The study comprised two randomized controlled trials (RCTs) with an identical design. RCT 1 was conducted with adults with T2DM. RCT 2 was performed in adults aged ≥50 years. Data were collected via face-to-face assessments. The participants decided either to increase their level of PA or to decrease their level of SB. The participants were randomly allocated with a 2:1 ratio to the intervention group or the waiting-list control group. They were not blinded for their group allocation. The participants in the intervention group were instructed to go through MyPlan 2.0, comprising 5 sessions with an interval of 1 week between each session. The primary outcomes were objectively measured and self-reported PA (ie, light PA, moderate-to-vigorous PA, total PA, number of steps, and domain-specific [eg, transport-related] PA) and SB (ie, sitting time, number of breaks from sitting time, and length of sitting bouts). Secondary outcomes were self-reported behavioral determinants for PA and SB (eg, self-efficacy). Separate linear mixed models were performed to analyze the effects of MyPlan 2.0 in the two samples. Results: In RCT 1 (n=54), the PA intervention group showed, in contrast to the control group, a decrease in self-reported time spent sitting (P=.09) and an increase in accelerometer-measured moderate (P=.05) and moderate-to-vigorous PA (P=.049). The SB intervention group displayed an increase in accelerometer-assessed breaks from sedentary time in comparison with the control group (P=.005). A total of 14 participants of RCT 1 dropped out. In RCT 2 (n=63), the PA intervention group showed an increase for self-reported total PA in comparison with the control group (P=.003). Furthermore, in contrast to the control group, the SB intervention group decreased their self-reported time spent sitting (P=.08) and increased their accelerometer-assessed moderate (P=.06) and moderate-to-vigorous PA (P=.07). A total of 8 participants of RCT 2 dropped out. Conclusions: For both the samples, the HAPA-based eHealth and mHealth intervention, MyPlan 2.0, was able to improve only some of the primary outcomes. Trial Registration: ClinicalTrials.gov NCT03291171; http://clinicaltrials.gov/ct2/show/NCT03291171. ClinicalTrials.gov NCT03799146; http://clinicaltrials.gov/ct2/show/NCT03799146. International Registered Report Identifier (IRRID): RR2-10.2196/12413 %M 31376274 %R 10.2196/13363 %U https://www.jmir.org/2019/8/e13363/ %U https://doi.org/10.2196/13363 %U http://www.ncbi.nlm.nih.gov/pubmed/31376274 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 8 %P e14145 %T An Internet-Based HIV Self-Testing Program to Increase HIV Testing Uptake Among Men Who Have Sex With Men in Brazil: Descriptive Cross-Sectional Analysis %A De Boni,Raquel Brandini %A Veloso,Valdilea Gonçalves %A Fernandes,Nilo Martinez %A Lessa,Flavia %A Corrêa,Renato Girade %A Lima,Renato De Souza %A Cruz,Marly %A Oliveira,Juliane %A Nogueira,Simone Muniz %A de Jesus,Beto %A Reis,Toni %A Lentini,Nena %A Miranda,Raquel Lima %A Bingham,Trista %A Johnson,Cheryl C %A Barbosa Junior,Aristides %A Grinsztejn,Beatriz %+ Instituto Nacional de Infectologia Evandro Chagas, Oswaldo Cruz Foundation, Av Brasil 4365, Rio de Janeiro, 20530-360, Brazil, 55 21 3865 9122, raqueldeboni@gmail.com %K HIV/AIDS %K HIV self-testing %K key populations %K mobile health %K men %D 2019 %7 01.08.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Approximately 30% of people living with HIV worldwide are estimated to be unaware of their infection. HIV self-testing (HIVST) is a strategy recommended by the World Health Organization to increase access to and uptake of testing among key populations who are at high risk for HIV infection. Objective: This study aimed to describe the development and feasibility of a free, anonymous, internet-based HIVST strategy designed for men who have sex with men in Curitiba, Brazil (electronic testing [e-testing]). Methods: The project was developed under the scope of the “A Hora é Agora” (The Time is Now) program. Individuals aiming to request an HIVST package (two tests each) answered an anonymous 5-minute questionnaire regarding inclusion criteria and sexual risk behavior. Eligible individuals could receive one package every 6 months for free. Website analytics, response to online questionnaires, package distribution, and return of test results were monitored via a platform-integrated system. Results: Between February 2015 and January 2016, the website documented 17,786 unique visitors and 3218 completed online questionnaires. Most individuals self-reported being white (77.0%), young (median age: 25 years, interquartile range: 22-31 years), educated (87.3% completed secondary education or more), and previously tested for HIV (62.5%). Overall, 2526 HIVST packages were delivered; of those, 542 (21.4%) reported a result online or by mail (23 reactive and 11 invalid). During the study period, 37 individuals who reported using e-testing visited the prespecified health facility for confirmatory testing (30 positive, 7 negative). Conclusions: E-testing proved highly feasible and acceptable in this study, thus supporting scale-up to additional centers for men who have sex with men in Brazil. %M 31373276 %R 10.2196/14145 %U https://www.jmir.org/2019/8/e14145/ %U https://doi.org/10.2196/14145 %U http://www.ncbi.nlm.nih.gov/pubmed/31373276 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 8 %P e12775 %T Exploring the Relationship Between Usage and Outcomes of an Internet-Based Intervention for Individuals With Depressive Symptoms: Secondary Analysis of Data From a Randomized Controlled Trial %A Enrique,Angel %A Palacios,Jorge E %A Ryan,Holly %A Richards,Derek %+ E-mental Health Research Group, School of Psychology, University of Dublin Trinity College, Dublin, 2, Ireland, 353 1 554 9771, enriquea@tcd.ie %K Web-based intervention %K depression %K adherence %K engagement %K eHealth %K internet %D 2019 %7 01.08.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet interventions can easily generate objective data about program usage. Increasingly, more studies explore the relationship between usage and outcomes, but they often report different metrics of use, and the findings are mixed. Thus, current evaluations fail to demonstrate which metrics should be considered and how these metrics are related to clinically meaningful change. Objective: This study aimed to explore the relationship between several usage metrics and outcomes of an internet-based intervention for depression. Methods: This is a secondary analysis of data from a randomized controlled trial that examined the efficacy of an internet-based cognitive behavioral therapy for depression (Space from Depression) in an adult community sample. All participants who enrolled in the intervention, regardless of meeting the inclusion criteria, were included in this study. Space from Depression is a 7-module supported intervention, delivered over a period of 8 weeks. Different usage metrics (ie, time spent, modules and activities completed, and percentage of program completion) were automatically collected by the platform, and composite variables from these (eg, activities per session) were computed. A breakdown of the usage metrics was obtained by weeks. For the analysis, the sample was divided into those who obtained a reliable change (RC)—and those who did not. Results: Data from 216 users who completed pre- and posttreatment outcomes were included in the analyses. A total of 89 participants obtained an RC, and 127 participants did not obtain an RC. Those in the RC group significantly spent more time, had more log-ins, used more tools, viewed a higher percentage of the program, and got more reviews from their supporter compared with those who did not obtain an RC. Differences between groups in usage were observed from the first week in advance across the different metrics, although they vanished over time. In the RC group, the usage was higher during the first 4 weeks, and then a significant decrease was observed. Our results showed that specific levels of platform usage, 7 hours total time spent, 15 sessions, 30 tools used, and 50% of program completion, were associated with RC. Conclusions: Overall, the results showed that those individuals who obtained an RC after the intervention had higher levels of exposure to the platform. The usage during the first half of the intervention was higher, and differences between groups were observed from the first week. This study also showed specific usage levels associated with outcomes that could be tested in controlled studies to inform the minimal usage to establish adherence. These results will help to better understand how to use internet-based interventions and what optimal level of engagement can most affect outcomes. Trial Registration: ISRCTN Registry ISRCTN03704676; http://www.isrctn.com/ISRCTN03704676 International Registered Report Identifier (IRRID): RR2-10.1186/1471-244X-14-147 %M 31373272 %R 10.2196/12775 %U https://www.jmir.org/2019/8/e12775/ %U https://doi.org/10.2196/12775 %U http://www.ncbi.nlm.nih.gov/pubmed/31373272 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 7 %P e13906 %T Barriers and Facilitators to the Implementation of a Mobile Insulin Titration Intervention for Patients With Uncontrolled Diabetes: A Qualitative Analysis %A Rogers,Erin %A Aidasani,Sneha R %A Friedes,Rebecca %A Hu,Lu %A Langford,Aisha T %A Moloney,Dana N %A Orzeck-Byrnes,Natasha %A Sevick,Mary Ann %A Levy,Natalie %+ Department of Population Health, New York University School of Medicine, 180 Madison Avenue, New York, NY, 10016, United States, 1 646 501 3556, erin.rogers@nyulangone.org %K type 2 diabetes %K telemedicine %K implementation science %D 2019 %7 31.07.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: In 2016, a short message service text messaging intervention to titrate insulin in patients with uncontrolled type 2 diabetes was implemented at two health care facilities in New York City. Objective: This study aimed to conduct a qualitative evaluation assessing barriers to and the facilitators of the implementation of the Mobile Insulin Titration Intervention (MITI) program into usual care. Methods: We conducted in-depth interviews with 36 patients enrolled in the MITI program and the staff involved in MITI (n=19) in the two health care systems. Interviews were transcribed and iteratively coded by two study investigators, both inductively and deductively using a codebook guided by the Consolidated Framework for Implementation Research. Results: Multiple facilitator themes emerged: (1) MITI had strong relative advantages to in-person titration, including its convenience and time-saving design, (2) the free cost of MITI was important to the patients, (3) MITI was easy to use and the patients were confident in their ability to use it, (4) MITI was compatible with the patients’ home routines and clinic workflow, (5) the patients and staff perceived MITI to have value beyond insulin titration by reminding and motivating the patients to engage in healthy behaviors and providing a source of patient support, and (6) implementation in clinics was made easy by having a strong implementation climate, communication networks to spread information about MITI, and a strong program champion. The barriers identified included the following: (1) language limitations, (2) initial nurse concerns about the scope of practice changes required to deliver MITI, (3) initial provider knowledge gaps about the program, and (4) provider perceptions that MITI might not be appropriate for some patients (eg, older or not tech-savvy). There was also a theme that emerged during the patient and staff interviews of an unmet need for long-term additional diabetes management support among this population, specifically diet, nutrition, and exercise support. Conclusions: The patients and staff were overwhelmingly supportive of MITI and believed that it had many benefits and that it was compatible with the clinic workflow and patients’ lives. Initial implementation efforts should address staff training and nurse concerns. Future research should explore options for integrating additional diabetes support for patients. %M 31368439 %R 10.2196/13906 %U http://mhealth.jmir.org/2019/7/e13906/ %U https://doi.org/10.2196/13906 %U http://www.ncbi.nlm.nih.gov/pubmed/31368439 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 3 %N 3 %P e12507 %T A Web-Based Physical Activity Portal for Individuals Living With a Spinal Cord Injury: Qualitative Study %A Pancer,Max %A Manganaro,Melissa %A Pace,Isabella %A Marion,Patrick %A Gagnon,Dany H %A Laramée,Marie-Thérèse %A Messier,Frédéric %A Amari,Fatima %A Ahmed,Sara %+ School of Physical & Occupational Therapy, Faculty of Medicine, McGill University, 3654 Prom Sir-William-Osler, Montreal, QC, H3G 1Y5, Canada, 1 514 487 1891 ext 185, sara.ahmed@mcgill.ca %K spinal cord injuries %K self-management %K internet %K exercise %K motivation %K volition %D 2019 %7 26.07.2019 %9 Original Paper %J JMIR Form Res %G English %X Background: The population with a spinal cord injury (SCI) largely remains inactive following discharge from rehabilitation despite evidence on the benefits of physical activity. These individuals need to develop skills to self-manage their condition in order to prevent secondary comorbidities and rehospitalization. A Web-based physical activity portal can address this need. Few Web-based interventions incorporate theoretical frameworks, behavior change techniques, and modes of delivery into their design. Objective: This study aimed to identify the preferred features of a Web-based self-management physical activity portal through stakeholder engagement with individuals with a spinal cord injury and health care professionals (HCPs). Methods: An interpretative phenomenology methodology and participatory design, along with an integrated knowledge translation approach, were used to conduct this study. Convenience sampling was used to recruit individuals with an SCI living in the community, who were either interested or already engaging in physical activity, and HCPs working with individuals with an SCI, from three city-based rehabilitation sites. Individual 1-hour sessions involving navigation of an existing website and a semistructured interview were conducted with all participants. Individuals with an SCI completed a demographics questionnaire prior to the individual sessions, while demographic information of the HCPs was collected during their interviews. Additionally, all participants were asked a question on their intention to use or recommend a portal. An in-depth thematic analysis was used to derive themes from participants’ responses. Results: Thirteen individuals with an SCI and nine HCPs participated in the study. Five core themes emerged: (1) knowledge: guidance and barrier management; (2) possibility of achievement: the risks and benefits of physical activity and modelling; (3) self-regulation strategies: action planning, goal setting, tracking, rewards, and reminders; (4) interactivity: peers and professionals; and (5) format: appearance, language, and ease of use. The mean (median) ratings of the likelihood of promoting and using a Web-based portal tailored to individuals’ needs were 9.00 (8.78) and 7.75 (7.88) for HCPs and individuals with an SCI, respectively. Conclusions: This study highlights features of an online self-management platform that can provide individuals with an SCI the motivation and volition to engage in physical activity. These findings will inform the design of a Web-based self-management physical activity portal to increase physical activity adherence and behavior change. %M 31350835 %R 10.2196/12507 %U http://formative.jmir.org/2019/3/e12507/ %U https://doi.org/10.2196/12507 %U http://www.ncbi.nlm.nih.gov/pubmed/31350835 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 7 %P e13063 %T Association Between Physical Activity Intervention Website Use and Physical Activity Levels Among Spanish-Speaking Latinas: Randomized Controlled Trial %A Linke,Sarah E %A Dunsiger,Shira I %A Gans,Kim M %A Hartman,Sheri J %A Pekmezi,Dori %A Larsen,Britta A %A Mendoza-Vasconez,Andrea S %A Marcus,Bess H %+ Department of Family Medicine and Public Health, University of California, San Diego, 9500 Gilman Drive, Box 0725, La Jolla, CA,, United States, 1 858 822 1082, slinke@ucsd.edu %K physical activity %K Latinas %K internet %K treatment engagement %D 2019 %7 24.07.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: The internet’s low cost and potential for high reach makes Web-based channels prime for delivering evidence-based physical activity (PA) interventions. Despite the well-studied success of internet-based PA interventions in primarily non-Hispanic white populations, evidence on Spanish-speaking Latinas’ use of such interventions is lacking. The recent rise in technology use among Latinas in the United States, a population at heightened risk for low PA levels and related conditions, suggests that they may benefit from Web-based PA interventions tailored to their cultural and language preferences. Objective: The goal of the research was to examine participant engagement with various features of an internet-based PA intervention for Latinas and explore how use of these features was differentially associated with adoption and maintenance of PA behavior change. Method: Pasos Hacia la Salud tested a Spanish-language, culturally adapted, individually tailored, internet-based PA intervention versus a Spanish language, internet-based, Wellness Contact Control condition for underactive Latinas (N=205, mean age 39.2 [SD 10.5] years, 84% Mexican American). These analyses examined engagement with the website and explored how use was associated with adoption and maintenance of moderate to vigorous physical activity (MVPA) behavior. Results: Overall, participants logged on to the website an average of 22 times (SD 28) over 12 months, with intervention participants logging on significantly more than controls (29 vs 14.7, P<.001). On average, participants spent more time on the website at months 1, 4, and 6 compared to all other months, with maximum use at month 4. Both log-ins and time spent on the website were significantly related to intervention success (achieving higher mean minutes of MVPA per week at follow-up: b=.48, SE 0.20, P=.02 for objectively measured MVPA and b=.74, SE 0.34, P=.03 for self-reported MVPA at 12 months, controlling for baseline). Furthermore, those meeting guidelines by the Centers for Disease Control and Prevention for PA at 12 months (≥150 minutes per week of MVPA) logged on significantly more than those not meeting guidelines (35 vs 20 over 12 months, P=.002). Among participants in the intervention arm, goal-setting features, personal PA reports, and PA tips were the most used portions of the website. Higher use of these features was associated with greater success in the program (significantly more minutes of self-reported MVPA at 12 months controlling for baseline). Specifically, one additional use of these features per month over 12 months translated into an additional 34 minutes per week of MVPA (goals feature), 12 minutes per week (PA tips), and 42 minutes per week (PA reports). Conclusions: These results demonstrate that greater use of a tailored, Web-based PA intervention, particularly certain features on the site, was significantly related to increased PA levels in Latinas. Trial Registration: ClinicalTrials.gov NCT01834287; https://clinicaltrials.gov/ct2/show/NCT01834287 %M 31342902 %R 10.2196/13063 %U http://www.jmir.org/2019/7/e13063/ %U https://doi.org/10.2196/13063 %U http://www.ncbi.nlm.nih.gov/pubmed/31342902 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 7 %P e14814 %T Dissemination and Effectiveness of the Peer Marketing and Messaging of a Web-Assisted Tobacco Intervention: Protocol for a Hybrid Effectiveness Trial %A Faro,Jamie M %A Orvek,Elizabeth A %A Blok,Amanda C %A Nagawa,Catherine S %A McDonald,Annalise J %A Seward,Gregory %A Houston,Thomas K %A Kamberi,Ariana %A Allison,Jeroan J %A Person,Sharina D %A Smith,Bridget M %A Brady,Kathleen %A Grosowsky,Tina %A Jacobsen,Lewis L %A Paine,Jennifer %A Welch Jr,James M %A Sadasivam,Rajani S %+ Division of Health Informatics and Implementation Science, Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, The Albert Sherman Center, 368 Plantation Street, Worcester, MA, 01605, United States, 1 (774) 455 3744, Jamie.faro@umassmed.edu %K smoking cessation %K peer recruitment %K digital Intervention %K tailored, dissemination %D 2019 %7 23.07.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Smoking continues to be the leading preventable cause of death. Digital Interventions for Smoking Cessation (DISCs) are health communication programs accessible via the internet and smartphones and allow for greater reach and effectiveness of tobacco cessation programs. DISCs have led to increased 6-month cessation rates while also reaching vulnerable populations. Despite this, the impact of DISCs has been limited and new ways to increase access and effectiveness are needed. Objective: We are conducting a hybrid effectiveness-dissemination study. We aim to evaluate the effectiveness of a machine learning–based approach (recommender system) for computer-tailored health communication (CTHC) over a standard CTHC system based on quit rates and risk reduction. In addition, this study will assess the dissemination of providing access to a peer recruitment toolset on recruitment rate and variability of the sample. Methods: The Smoker-to-Smoker (S2S) study is a 6-month hybrid effectiveness dissemination trial conducted nationally among English-speaking, current smokers aged ≥18 years. All eligible participants will register for the DISC (Decide2quit) and be randomized to the recommender system CTHC or the standard CTHC, followed by allocation to a peer recruitment toolset group or control group. Primary outcomes will be 7-day point prevalence and risk reduction at the 6-month follow-up. Secondary outcomes include recruitment rate, website engagement, and patient-reported outcomes collected via the 6-month follow-up questionnaire. All primary analyses will be conducted on an intent-to-treat basis. Results: The project is funded from 2017 to 2020 by the Patient Centered Outcomes Research Institute. Enrollment was completed in early 2019, and 6-month follow-ups will be completed by late 2019. Preliminary data analysis is currently underway. Conclusions: Conducting a hybrid study with both effectiveness and dissemination hypotheses raises some unique challenges in the study design and analysis. Our study addresses these challenges to test new innovations and increase the effectiveness and reach of DISCs. International Registered Report Identifier (IRRID): DERR1-10.2196/14814 %M 31339104 %R 10.2196/14814 %U http://www.researchprotocols.org/2019/7/e14814/ %U https://doi.org/10.2196/14814 %U http://www.ncbi.nlm.nih.gov/pubmed/31339104 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 7 %P e13065 %T The Cost-Effectiveness of an Internet Intervention to Facilitate Mental Health Help-Seeking by Young Adults: Randomized Controlled Trial %A Le,Long Khanh-Dao %A Sanci,Lena %A Chatterton,Mary Lou %A Kauer,Sylvia %A Buhagiar,Kerrie %A Mihalopoulos,Cathrine %+ Deakin Health Economics, Institute for Health Transformation, School of Health and Social Development, Deakin University, 221 Burwood Highway, Burwood, 3125, Australia, 61 392468383, long.le@deakin.edu.au %K economic evaluation %K cost effectiveness %K mental health %K help-seeking %K internet intervention %D 2019 %7 22.07.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Little empirical evidence is available to support the effectiveness and cost-effectiveness of internet interventions to increase help-seeking behavior for mental health in young adults. Objective: The aim of this study was to evaluate the cost-effectiveness of a Web-based mental health help-seeking navigation tool (Link) in comparison with usual help-seeking strategies. Methods: A cost-utility analysis alongside the main randomized trial of Link was conducted from the Australian health care sector perspective. Young adults aged 18 to 25 years were randomized to the Link intervention (n=205) or usual care (n=208) with 1- and 3-month follow-ups. The primary outcome of this study was quality-adjusted life years (QALYs) measured by the assessment of quality of life–4D. Costs were calculated based on the self-reported resource use questionnaire and were reported in 2015 Australian dollars. Primary analyses were conducted as intention-to-treat and reported as incremental cost-effectiveness ratios. Completer analyses were conducted in a sensitivity analysis. Results: Significantly more QALYs were gained in the intervention group than the control group (0.15 vs 0.14; P<.001). The intervention was associated with significantly lower health professional consultation costs at 1-month follow-up (mean costs Aus $98 vs Aus $162; P<.05). Costs of hospital services were lower at 3 months in the intervention arm (mean costs Aus $47 vs Aus $101); however, there was insufficient sample size to detect a significant difference between the groups. There were no statistically significant differences in the total costs between the 2 arms. Relative to the control group, those who received the intervention experienced 0.01 more QALYs (0.00-0.02) and had lower total health sector costs of Aus −$81 (Aus −$348 to Aus $186) over 3 months. The intervention was found to be more effective and less costly compared with usual help-seeking strategies. The intervention was 100% likely to be cost-effective below a willingness-to-pay value-for-money threshold of Aus $28,033 per QALY. Results were robust in the sensitivity analysis. Conclusions: Our study found that the online youth mental health help-seeking Web service is a cost-effective intervention for young people aged 18 to 25 years compared with usual search strategies. Further research is required to confirm these results. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12614001223628; https://www.anzctr.org.au /Trial/Registration/TrialReview.aspx?id=366731 %M 31333199 %R 10.2196/13065 %U http://www.jmir.org/2019/7/e13065/ %U https://doi.org/10.2196/13065 %U http://www.ncbi.nlm.nih.gov/pubmed/31333199 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 7 %P e12869 %T Digital Mental Health Interventions for Depression, Anxiety, and Enhancement of Psychological Well-Being Among College Students: Systematic Review %A Lattie,Emily G %A Adkins,Elizabeth C %A Winquist,Nathan %A Stiles-Shields,Colleen %A Wafford,Q Eileen %A Graham,Andrea K %+ Center for Behavioral Intervention Technologies, Northwestern University, 750 N Lake Shore Drive, 10th Floor, Chicago, IL, 60611, United States, 1 3125033741, emily.lattie@northwestern.edu %K eHealth %K mHealth %K mental health %K students %K universities %D 2019 %7 22.07.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: College students are increasingly reporting common mental health problems, such as depression and anxiety, and they frequently encounter barriers to seeking traditional mental health treatments. Digital mental health interventions, such as those delivered via the Web and apps, offer the potential to improve access to mental health treatment. Objective: This study aimed to review the literature on digital mental health interventions focused on depression, anxiety, and enhancement of psychological well-being among samples of college students to identify the effectiveness, usability, acceptability, uptake, and adoption of such programs. Methods: We conducted a systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (registration number CRD42018092800), and the search strategy was conducted by a medical research librarian in the following databases: MEDLINE (Ovid), EMBASE (Elsevier), PsycINFO (EbscoHost), the Cochrane Library (Wiley), and Web of Science (Thomson Reuters) from the date of inception to April 2019. Data were synthesized using a systematic narrative synthesis framework, and formal quality assessments were conducted to address the risk of bias. Results: A total of 89 studies met the inclusion criteria. The majority of interventions (71/89, 80%) were delivered via a website, and the most common intervention was internet-based cognitive behavioral therapy (28, 31%). Many programs (33, 37%) featured human support in the form of coaching. The majority of programs were either effective (42, 47%) or partially effective (30, 34%) in producing beneficial changes in the main psychological outcome variables. Approximately half of the studies (45, 51%) did not present any usability or acceptability outcomes, and few studies (4, 4%) examined a broad implementation of digital mental health interventions on college campuses. Quality assessments revealed a moderate-to-severe risk of bias in many of the studies. Conclusions: Results suggest that digital mental health interventions can be effective for improving depression, anxiety, and psychological well-being among college students, but more rigorous studies are needed to ascertain the effective elements of these interventions. Continued research on improving the user experience of, and thus user engagement with, these programs appears vital for the sustainable implementation of digital mental health interventions on college campuses. %M 31333198 %R 10.2196/12869 %U http://www.jmir.org/2019/7/e12869/ %U https://doi.org/10.2196/12869 %U http://www.ncbi.nlm.nih.gov/pubmed/31333198 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 7 %P e11086 %T An Evaluation of the Effectiveness of the Modalities Used to Deliver Electronic Health Interventions for Chronic Pain: Systematic Review With Network Meta-Analysis %A Slattery,Brian W %A Haugh,Stephanie %A O'Connor,Laura %A Francis,Kady %A Dwyer,Christopher P %A O'Higgins,Siobhán %A Egan,Jonathan %A McGuire,Brian E %+ School of Nursing and Human Sciences, Dublin City University, Glasnevin, Dublin, 9, Ireland, 353 017008034, brian.slattery@dcu.ie %K eHealth %K mHealth %K digital health %K Virtual Reality %K chronic pain %K systematic review %K network meta-analysis %D 2019 %7 17.07.2019 %9 Review %J J Med Internet Res %G English %X Background: Electronic health (eHealth) is the use of information and communication technology in the context of health care and health research. Recently, there has been a rise in the number of eHealth modalities and the frequency with which they are used to deliver technology-assisted self-management interventions for people living with chronic pain. However, there has been little or no research directly comparing these eHealth modalities. Objective: The aim of this systematic review with a network meta-analysis (NMA) is to compare the effectiveness of eHealth modalities in the context of chronic pain. Methods: Randomized controlled trials (N>20 per arm) that investigated interventions for adults with chronic pain, delivered via an eHealth modality, were included. Included studies were categorized into their primary node of delivery. Data were extracted on the primary outcome, pain interference, and secondary outcomes, pain severity, psychological distress, and health-related quality of life. Pairwise meta-analyses were undertaken where possible, and an NMA was conducted to generate indirect comparisons and rankings of modalities for reducing pain interference. Results: The search returned 18,470 studies with 18,349 being excluded (duplicates=2310; title and abstract=16,039). Of the remaining papers, 30 studies with 5394 randomized participants were included in the review. Rankings tentatively indicated that modern eHealth modalities are the most effective, with a 43% chance that mobile apps delivered the most effective interventions, followed by a 34% chance that interventions delivered via virtual reality were the most effective. Conclusions: This systematic review with an NMA generated comparisons between eHealth modalities previously not compared to determine which delivered the most effective interventions for the reduction of pain interference in chronic pain patients. There are limitations with this review, in particular, the underrepresented nature of some eHealth modalities included in the analysis. However, in the event that the review is regularly updated, a clear ranking of eHealth modalities for the reduction of pain interference will emerge. %M 31317869 %R 10.2196/11086 %U https://www.jmir.org/2019/7/e11086/ %U https://doi.org/10.2196/11086 %U http://www.ncbi.nlm.nih.gov/pubmed/31317869 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 7 %P e13164 %T An Electronic Health Intervention for Dutch Women With Stress Urinary Incontinence: Protocol for a Mixed Methods Study %A Firet,Lotte %A Teunissen,Theodora Alberta Maria %A van der Vaart,Huub %A Assendelft,Willem Jan Jozef %A Notten,Kim Josephina Bernadette %A Kool,Rudolf Bertijn %A Lagro-Janssen,Antoinette Leonarda Maria %+ Department of Primary and Community Care, Radboud Institute for Health Sciences, Radboud University Medical Center, Geert Grooteplein 21, Postbox 9101, Nijmegen, 6500 HB, Netherlands, 31 24 3613110, lotte.firet@radboudumc.nl %K eHealth %K urinary incontinence %K women %K mixed methods design %K pelvic floor muscle training %K study protocol %D 2019 %7 11.07.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Stress urinary incontinence (SUI) is a common problem with a great potential influence on quality of life. Although SUI can be treated effectively with pelvic floor muscle training (PFMT), only a minority of women with this complaint seek help. An internet-based electronic health (eHealth) intervention could make care more accessible. The Swedish eHealth intervention Tät-treatment of Stress Urinary Incontinence offers PFMT and has shown to be effective in reducing symptoms in women with SUI. This intervention might be helpful for Dutch women too, but its adoption needs to be studied as the Netherlands differs from Sweden in terms of geographical characteristics and health care organization. Objective: The objective of this protocol is to investigate the barriers and facilitators to the adoption of an eHealth intervention for Dutch women with SUI and the effects of this intervention. Methods: We are conducting an explanatory sequential mixed methods study among 800 Dutch women with SUI who participate in the translated version of Tät-treatment of Stress Urinary Incontinence. This eHealth intervention takes 3 months. A pre-post study is conducted using surveys, which are sent at baseline (T0), 3 weeks after baseline (T1), posttreatment (T2), and 3 months posttreatment (T3). After the intervention, semistructured interviews will be held with 15 to 20 participants. The primary outcomes are barriers and facilitators to using the Tät-treatment of Stress Urinary Incontinence. This will also be analyzed among groups that differ in age and severity of incontinence. A thematic content analysis of the qualitative data will be performed. The secondary outcomes are: (1) effect on symptoms of urinary incontinence, (2) effect on quality of life, and (3) factors that are potentially associated with success. Effects will be analyzed by a mixed model analysis. Logistic regression analysis will be used to study what patient-related factors are associated with success. Results: Enrollment started in July 2018 and will be finished by December 2019. Data analysis will start in March 2020. Conclusions: An eHealth intervention for Dutch women with SUI is promising because it can make treatment more accessible. The strength of this study is that it explores the possibilities for an internet-based-only treatment for women with SUI by using both quantitative and qualitative research methodologies. The study elaborates on existing results by using a previously tested and effective eHealth program. Insight into the barriers and facilitators to using this program can enhance the implementation of the intervention in the Dutch health care system. Trial Registration: Netherlands Trial Registry (NTR) NTR6956; https://www.trialregister.nl/trial/6570. International Registered Report Identifier (IRRID): DERR1-10.2196/13164 %M 31298222 %R 10.2196/13164 %U https://www.researchprotocols.org/2019/7/e13164/ %U https://doi.org/10.2196/13164 %U http://www.ncbi.nlm.nih.gov/pubmed/31298222 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 7 %P e10876 %T Internet-Based Interventions for Carers of Individuals With Psychiatric Disorders, Neurological Disorders, or Brain Injuries: Systematic Review %A Spencer,Lucy %A Potterton,Rachel %A Allen,Karina %A Musiat,Peter %A Schmidt,Ulrike %+ Section of Eating Disorders, Institute of Psychiatry, Psychology, and Neuroscience, King’s College London, 16 De Crespigny Park, London, SE5 8AF, United Kingdom, 44 2078485608, lucy.spencer@kcl.ac.uk %K internet %K carers %K mental health %K technology %K review %D 2019 %7 09.07.2019 %9 Review %J J Med Internet Res %G English %X Background: Nonprofessional carers who provide support to an individual with a psychiatric or neurological disorder will often themselves experience symptoms of stress, anxiety, or low mood, and they perceive that they receive little support. Internet-based interventions have previously been found to be effective in the prevention and treatment of a range of mental health difficulties in carers. Objective: This review seeks to establish the status of internet-based interventions for informal (nonprofessional) carers of people with psychiatric or neurological disorders by investigating (1) the number and quality of studies evaluating the efficacy or effectiveness of internet-based carer interventions and (2) the impact that such interventions have on carer mental health, as well as (3) how internet-based interventions compare with other intervention types (eg, face-to-face treatment). Methods: A systematic literature search was conducted in January 2019 using the EMBASE (1974-present), Ovid MEDLINE (1946-present), PsychARTICLES, PsychINFO (1806-present), and Global Health (1973-present) databases, via the Ovid Technologies database. Search terms included carer, caregiver, online, technology, internet-based, internet, interactive, intervention, and evaluation. Studies selected for inclusion in this review met the following predetermined criteria: (1) delivering an intervention aimed primarily at informal carers, (2) carers supporting individuals with psychiatric disorders, stroke, dementia, or brain injury, (3) the intervention delivered to the carers was primarily internet based, (4) the study reported a pre- and postquantitative measure of carer depression, anxiety, stress, burden, or quality of life, (5) appeared in a peer-reviewed journal, and (6) was accessible in English. Results: A total of 46 studies were identified for inclusion through the detailed search strategy. The search was conducted, and data were extracted independently by 2 researchers. The majority of studies reported that 1 or more measures relating to carer mental health improved following receipt of a relevant intervention, with interventions for carers of people with traumatic brain injury showing a consistent link with improved outcomes. Conclusions: Studies investigating internet-based interventions for carers of individuals with diverse psychiatric or neurological difficulties show some evidence in support of the effectiveness of these interventions. In addition, such interventions are acceptable to carers. Available evidence is of varying quality, and more high-quality trials are needed. Further research should also establish how specific intervention components, such as structure or interactivity, contribute to their overall efficacy with regard to carer mental health. %M 31290399 %R 10.2196/10876 %U https://www.jmir.org/2019/7/e10876/ %U https://doi.org/10.2196/10876 %U http://www.ncbi.nlm.nih.gov/pubmed/31290399 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 6 %P e13360 %T The Symptoms Targeted for Monitoring in a Web-Based Tracking Tool by Caregivers of People With Dementia and Agitation: Cross-Sectional Study %A Rockwood,Kenneth %A Sanon Aigbogun,Myrlene %A Stanley,Justin %A Wong,Helen %A Dunn,Taylor %A Chapman,Chère A T %A Howlett,Susan E %A Miguelez,Maia %A McGarrigle,Lisa %A Baker,Ross A %+ Geriatric Medicine Research Unit, Nova Scotia Health Authority, 5955 Veterans' Memorial Lane, Halifax, NS, B3H 2E9, Canada, 1 902 473 8687, kenneth.rockwood@dal.ca %K Alzheimer disease %K dementia %K agitation %K neuropsychiatric symptoms %K internet %K caregiver %D 2019 %7 28.06.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: In people with dementia, neuropsychiatric symptoms (NPSs), especially agitation, are associated with worse quality of life and caregiver burden. As NPSs may vary with illness severity, knowledge of how people with dementia and their caregivers describe and rate the importance of agitation symptoms can improve the understanding of the clinical meaningfulness of the manifestations of agitation. The internet provides new opportunities to better understand patient experiences, as patients and caregivers increasingly look to Web-based platforms as a means of managing symptoms. Objective: The aim of this study was to examine Web-based reports from a dementia symptom website to better understand the symptoms of agitation and explore how they are being targeted for monitoring by caregivers of people with dementia. Methods: The Dementia Guide website hosts a Web-based database used by caregivers (97%) and people with dementia (3%). From its 61 dementia symptoms, users can select relevant symptoms that they deem important to monitor or track the effects of treatment. We employed a staging algorithm to determine if individuals had mild cognitive impairment (MCI) or mild, moderate, or severe dementia. Agitation was defined using terms consistent with the International Psychogeriatrics Association’s provisional consensus definition. We compared the proportion of people with NPSs and agitation across stages of dementia severity and studied how many agitation-defining descriptors were selected, and how often they occurred, by stage. Results: As of March 2017, 4121 people had used the tracking tool, of whom 2577 provided sufficient data to allow disease severity staging. NPSs were tracked by 2127/2577 (82.54%) and agitation by 1898/2577 (73.65%). The proportion in whom agitation was tracked increased with increasing cognitive impairment: 68.5% (491/717) in people with MCI, and 72.50% (754/1040), 73.3% (378/516), and 90.5% (275/304) in mild, moderate, and severe dementia, respectively (χ23=54.9; P<.001). The number of NPS and agitation descriptors selected also increased with severity (median number of NPSs=1, 2, 2, and 3 for MCI, mild, moderate, and severe dementia, respectively, Kruskal-Wallis H Test H3=250.47; P<.001; median number of agitation descriptors=1, 2, 3, and 4, H3=146.11; P<.001). Conclusions: NPSs and agitation are common targets for tracking over the course of dementia and appear more frequently with increasing disease severity. These common and distressing symptoms represent clinically meaningful targets in treating people with dementia. %M 31254339 %R 10.2196/13360 %U https://www.jmir.org/2019/6/e13360/ %U https://doi.org/10.2196/13360 %U http://www.ncbi.nlm.nih.gov/pubmed/31254339 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 6 %P e13965 %T A Mobility-Focused Knowledge Translation Randomized Controlled Trial to Improve Physical Activity: Process Evaluation of the Move4Age Study %A Neil-Sztramko,Sarah E %A Smith-Turchyn,Jenna %A Richardson,Julie %A Dobbins,Maureen %+ School of Nursing, McMaster University, 175 Longwood Road South, Suite 210a, Hamilton, ON, L8P0A1, Canada, 1 9055259140 ext 20459, neilszts@mcmaster.ca %K process evaluation %K physical activity %K health information %K mobility %K older adults %K knowledge translation %D 2019 %7 20.06.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Maintaining physical activity and physical function is important for healthy aging. We recently completed a randomized controlled trial of a targeted knowledge translation (KT) intervention delivered through the McMaster Optimal Aging Portal with the goal to increase physical activity and physical mobility in middle-aged and older adults, with results reported elsewhere. Objective: The purpose of this process evaluation study is to explore which KT strategies were used by both intervention and control group participants, as well as the intervention groups’ engagement, satisfaction, and perceived usefulness of the targeted KT intervention. Methods: Data on engagement with the intervention materials were gathered quantitatively through Google Analytics and Hootsuite throughout the intervention. Qualitative data were collected through a combination of open-ended surveys and qualitative interviews with a subset of participants at the end of the study to further understand engagement, satisfaction, and usefulness of the KT strategies. Results: Throughout the intervention period, engagement with content delivered through weekly emails was highest, and participants rated email content most favorably in both surveys and interviews. Participants were generally satisfied with the intervention, noting the ease of participating and the distillation of information in an easy-to-access format being beneficial features. Participants who did not find the intervention useful were those with already high levels of baseline physical activity or physical function and those who were looking for more specific or individualized content. Conclusions: This process evaluation provides insight into our randomized controlled trial findings and provides information that can be used to improve future online KT interventions. Trial Registration: ClinicalTrials.gov NCT02947230; https://clinicaltrials.gov/ct2/show/nct02947230 (Archived by WebCite at http://www.webcitation.org/78t4tR8tM) %M 31223121 %R 10.2196/13965 %U http://www.jmir.org/2019/6/e13965/ %U https://doi.org/10.2196/13965 %U http://www.ncbi.nlm.nih.gov/pubmed/31223121 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 6 %P e13500 %T Comparing Treatment Acceptability and 12-Month Cessation Rates in Response to Web-Based Smoking Interventions Among Smokers Who Do and Do Not Screen Positive for Affective Disorders: Secondary Analysis %A Watson,Noreen L %A Heffner,Jaimee L %A Mull,Kristin E %A McClure,Jennifer B %A Bricker,Jonathan B %+ Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, M3-B232, Seattle, WA,, United States, 1 206 667 2942, nlwatson@fredhutch.org %K smoking %K smoking cessation %K affective disorders %K anxiety %K depression %K eHealth %K Web intervention %K co-occurring disorders %D 2019 %7 19.06.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based cessation programs are now common for intervening with smokers. However, it remains unclear how acceptable or effective these interventions are among people with affective disorders and symptoms (ADS; eg, depression and anxiety). Research examining this is extremely limited, with mixed results on cessation rates. Additional large studies are needed to more fully understand whether Web-based interventions are similarly used and equally effective among people with and without affective disorder symptomology. If not, more targeted Web-based interventions may be required. Objective: The goal of the research was to compare Web-based treatment acceptability (defined by satisfaction and use) and 12-month cessation outcomes between smokers with and without ADS. Methods: Participants (N=2512) were adult smokers enrolled in a randomized, comparative effectiveness trial of two Web-based smoking interventions designed for the general population of smokers. At baseline, participants reported demographic and smoking characteristics and completed measures assessing ADS. Participants were then classified into subgroups based on their self-reported ADS—either into a no ADS group or into six nonmutually exclusive subgroups: depression, posttraumatic stress disorder (PTSD), panic disorder (PD), generalized anxiety disorder (GAD), social anxiety disorder (SAD), and more than one ADS. Surveys at 12 months postrandomization included subjective ratings of treatment acceptability and self-reported smoking cessation. Treatment use (ie, number of log-ins and total duration of exposure) was assessed via automated records. Results: Relative to the no ADS group, all six ADS subgroups reported significantly greater satisfaction with their assigned Web treatment program, but they spent less time logged in than those with no ADS. For number of log-ins, a treatment arm by ADS group interaction was observed across all ADS subgroups except GAD, suggesting that relative to the no ADS group, they logged in less to one website but not the other. At the 12-month follow-up, abstinence rates in the no ADS group (153/520, 29.42%) were significantly higher than for participants who screened positive for depression (306/1267, 24.15%; P=.03), PTSD (294/1215, 24.19%; P=.03), PD (229/1003, 23.83%; P=.009), and two or more ADS (323/1332, 24.25%; P=.03). Post hoc analyses suggest the lower quit rates may be associated with differences in baseline nicotine dependence and levels of commitment to resist smoking in difficult situations. Website use did not explain the differential abstinence rates. Conclusions: Despite reporting higher levels of treatment satisfaction, most smokers with ADS used their assigned intervention less often and had lower quit rates than smokers with no ADS at treatment onset. The results support the need for developing more targeted interventions for smokers with ADS. Trial registration: Clinical Trials.gov NCT01812278; https://clinicaltrials.gov/ct2/show/NCT01812278 (Archived by WebCite at http://www.webcitation.org/78L9cNdG4) %M 31219052 %R 10.2196/13500 %U https://www.jmir.org/2019/6/e13500/ %U https://doi.org/10.2196/13500 %U http://www.ncbi.nlm.nih.gov/pubmed/31219052 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 6 %P e12285 %T Implementation of a Web-Based Work-Related Psychological Aftercare Program Into Clinical Routine: Results of a Longitudinal Observational Study %A Zwerenz,Rüdiger %A Baumgarten,Carlotta %A Dahn,Ingo %A Labitzke,Nicole %A Schwarting,Andreas %A Rudolph,Matthias %A Ferdinand,Peter %A Dederichs-Masius,Ute %A Beutel,Manfred E %+ Department for Psychosomatic Medicine and Psychotherapy, University Medical Center, Johannes Gutenberg-University, Untere Zahlbacher Str 8, Mainz, 55131, Germany, 49 6131175981, ruediger.zwerenz@unimedizin-mainz.de %K aftercare %K internet %K mental health %K psychotherapeutic processes %K return to work %K occupational stress %K health plan implementation %D 2019 %7 18.06.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: As inpatient medical rehabilitation serves to promote work ability, vocational reintegration is a crucial outcome. However, previous Web-based trials on coping with work-related stress have been limited to Web-based recruitment of study participants. Objective: The aim of our study was to evaluate the implementation of an empirically supported transdiagnostic psychodynamic Web-based aftercare program GSA (Gesund und Stressfrei am Arbeitsplatz [Healthy and stress-less at the workplace])-Online plus into the clinical routine of inpatient medical rehabilitation, to identify characteristics of patients who have received the recommendation for GSA-Online plus, and to determine helpfulness of the intervention and satisfaction of the participants as well as improvement in quality of life and mental health status of the regular users of GSA-Online plus. Methods: GSA-Online plus was prescribed by physicians at termination of orthopedic psychosomatic inpatient rehabilitation. Participants’ use of the program, work-related attitudes, distress, and quality of life were assessed on the Web. Results: In 2 rehabilitation centers, 4.4% (112/2562) of rehabilitants got a recommendation for GSA-Online plus during inpatient rehabilitation. Compared with usual person aftercare, the Web-based aftercare program was rarely recommended by physicians. Recommendations were made more frequently in psychosomatic (69/1172, 5.9%) than orthopedic (43/1389, 3.1%) rehabilitation (χ21=11.845, P=.001, Cramér V=−0.068) and to younger patients (P=.004, d=0.28) with longer inpatient treatment duration (P<.001, r=−0.12) and extended sick leaves before inpatient medical rehabilitation (P=.004; Cramér V=0.072). Following recommendation, 77% (86/112) of rehabilitants participated in Web-based aftercare. Completers (50/86, 58%) reported statistically significant improvements between discharge of inpatient treatment and the end of the aftercare program for subjective work ability (P=.02, d=0.41), perceived stress (P=.01, d=−0.38), functioning (P=.002, d=−0.60), and life satisfaction (P=.008, d=0.42). Conclusions: Physicians’ recommendations of Web-based aftercare are well accepted by patients who derive considerable benefits from participation. However, a low rate of prescription compared with other usual aftercare options points to barriers among physicians to prescribing Web-based aftercare. %M 31215515 %R 10.2196/12285 %U http://www.jmir.org/2019/6/e12285/ %U https://doi.org/10.2196/12285 %U http://www.ncbi.nlm.nih.gov/pubmed/31215515 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 6 %P e13253 %T Understanding Long-Term Trajectories in Web-Based Happiness Interventions: Secondary Analysis From Two Web-Based Randomized Trials %A Sanders,Christopher A %A Schueller,Stephen M %A Parks,Acacia C %A Howell,Ryan T %+ Department of Psychological Sciences, University of Missouri, Columbia, 210 McAlester Hall, 320 S 6th St, Columbia, MO, 65211, United States, 1 573 882 6860, c.a.sanders@mail.missouri.edu %K cluster analysis %K depression %K happiness %K random allocation %D 2019 %7 8.6.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: A critical issue in understanding the benefits of Web-based interventions is the lack of information on the sustainability of those benefits. Sustainability in studies is often determined using group-level analyses that might obscure our understanding of who actually sustains change. Person-centric methods might provide a deeper knowledge of whether benefits are sustained and who tends to sustain those benefits. Objective: The aim of this study was to conduct a person-centric analysis of longitudinal outcomes, examining well-being in participants over the first 3 months following a Web-based happiness intervention. We predicted we would find distinct trajectories in people’s pattern of response over time. We also sought to identify what aspects of the intervention and the individual predicted an individual’s well-being trajectory. Methods: Data were gathered from 2 large studies of Web-based happiness interventions: one in which participants were randomly assigned to 1 of 14 possible 1-week activities (N=912) and another wherein participants were randomly assigned to complete 0, 2, 4, or 6 weeks of activities (N=1318). We performed a variation of K-means cluster analysis on trajectories of life satisfaction (LS) and affect balance (AB). After clusters were identified, we used exploratory analyses of variance and logistic regression models to analyze groups and compare predictors of group membership. Results: Cluster analysis produced similar cluster solutions for each sample. In both cases, participant trajectories in LS and AB fell into 1 of 4 distinct groups. These groups were as follows: those with high and static levels of happiness (n=118, or 42.8%, in Sample 1; n=306, or 52.8%, in Sample 2), those who experienced a lasting improvement (n=74, or 26.8% in Sample 1; n=104, or 18.0%, in Sample 2), those who experienced a temporary improvement but returned to baseline (n=37, or 13.4%, in Sample 1; n=82, or 14.2%, in Sample 2), and those with other trajectories (n=47, or 17.0%, in Sample 1; n=87, or 15.0% in Sample 2). The prevalence of depression symptoms predicted membership in 1 of the latter 3 groups. Higher usage and greater adherence predicted sustained rather than temporary benefits. Conclusions: We revealed a few common patterns of change among those completing Web-based happiness interventions. A noteworthy finding was that many individuals began quite happy and maintained those levels. We failed to identify evidence that the benefit of any particular activity or group of activities was more sustainable than any others. We did find, however, that the distressed portion of participants was more likely to achieve a lasting benefit if they continued to practice, and adhere to, their assigned Web-based happiness intervention. %M 31199342 %R 10.2196/13253 %U http://www.jmir.org/2019/6/e13253/ %U https://doi.org/10.2196/13253 %U http://www.ncbi.nlm.nih.gov/pubmed/31199342 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 6 %P e12556 %T Guided Self-Help Works: Randomized Waitlist Controlled Trial of Pacifica, a Mobile App Integrating Cognitive Behavioral Therapy and Mindfulness for Stress, Anxiety, and Depression %A Moberg,Christine %A Niles,Andrea %A Beermann,Dale %+ Pacifica Labs, Inc, 150 S 5th Street, Suite 825, Minneapolis, MN, 55402, United States, 1 6083470325, christine.moberg@gmail.com %K mHealth %K anxiety %K depression %K stress %K cognitive behavioral therapy %K smartphone app %D 2019 %7 8.6.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite substantial improvements in technology and the increased demand for technology-enabled behavioral health tools among consumers, little progress has been made in easing the burden of mental illness. This may be because of the inherent challenges of conducting traditional clinical trials in a rapidly evolving technology landscape. Objective: This study sought to validate the effectiveness of Pacifica, a popular commercially available app for the self-management of mild-to-moderate stress, anxiety, and depression. Methods: A total of 500 adults with mild-to-moderate anxiety or depression were recruited from in-app onboarding to participate in a randomized waitlist controlled trial of Pacifica. We conducted an all-virtual study, recruiting, screening, and randomizing participants through a Web-based participant portal. Study participants used the app for 1 month, with no level of use required, closely mimicking real-world app usage. Participants in the waitlist group were given access to the app after 1 month. Measurements included self-reported symptoms of stress, anxiety, depression, and self-efficacy. We performed an intent-to-treat analysis to examine the interactive effects of time and condition. Results: We found significant interactions between time and group. Participants in the active condition demonstrated significantly greater decreases in depression, anxiety, and stress and increases in self-efficacy. Although we did not find a relationship between overall engagement with the app and symptom improvement, participants who completed relatively more thought record exercises sustained improvements in their symptoms through the 2-month follow-up to a greater degree than those who completed fewer. In addition, we found that participants who reported concomitantly taking psychiatric medications during the trial benefitted less from the app, as measured by the symptoms of anxiety and stress. Conclusions: This study provides evidence that Pacifica, a popular commercially available self-help app, is effective in reducing self-reported symptoms of depression, anxiety, and stress, particularly among individuals who utilize thought records and are not taking psychiatric medication. Trial Registration: ClinicalTrials.gov NCT03333707; https://clinicaltrials.gov/ct2/show/NCT03333707 (Archived by WebCite at http://www.webcitation.org/78YE07ADB) %M 31199319 %R 10.2196/12556 %U https://www.jmir.org/2019/6/e12556/ %U https://doi.org/10.2196/12556 %U http://www.ncbi.nlm.nih.gov/pubmed/31199319 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 6 %P e10980 %T Use of Web-Based Health Services in Individuals With and Without Symptoms of Hypochondria: Survey Study %A Eichenberg,Christiane %A Schott,Markus %+ Sigmund Freud Privat Universität Wien, Freudpl 3, Vienna, 1020, Austria, 49 15124049991, markus.s.c.schott@gmail.com %K hypochondria %K eHealth %K anxiety %K survey %D 2019 %7 10.6.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: An increasing number of people consult physicians because of distressing information found online. Cyberchondria refers to the phenomenon of health anxiety because of online health information. Objective: This study aimed to examine online health research of individuals with and without symptoms of hypochondria and their impact on health anxiety as well as behavior. Methods: An online survey was conducted. Demographic data, health-related internet use, and general health behavior were assessed. The illness attitude scale was used to record symptoms of hypochondria. Results: The final sample consisted of N=471 participants. More than 40% (188/471) of participants showed at least some symptoms of hypochondria. Participants with symptoms of hypochondria used the internet more frequently for health-related purposes and also frequented more online services than individuals without symptoms. Most online health services were rated as more reliable by individuals with symptoms of hypochondria. Changes to behavior such as doctor hopping or ordering nonprescribed medicine online were considered more likely by individuals with symptoms of hypochondria. Conclusions: Results show that individuals with symptoms of hypochondria do not turn to online research as a result of lacking alternatives but rather consult health services on- as well as offline. %M 31199311 %R 10.2196/10980 %U https://www.jmir.org/2019/6/e10980/ %U https://doi.org/10.2196/10980 %U http://www.ncbi.nlm.nih.gov/pubmed/31199311 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 6 %P e11934 %T Data Mining in the Development of Mobile Health Apps: Assessing In-App Navigation Through Markov Chain Analysis %A Stragier,Jeroen %A Vandewiele,Gilles %A Coppens,Paulien %A Ongenae,Femke %A Van den Broeck,Wendy %A De Turck,Filip %A De Marez,Lieven %+ imec-mict, Department of Communication Sciences, Ghent University, Miriam Makeplein 1, Ghent, 9000, Belgium, 32 92649745, jeroen.stragier@ugent.be %K eHealth %K mHealth %K Markov Chain %K log data %K data analytics %D 2019 %7 07.06.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Mobile apps generate vast amounts of user data. In the mobile health (mHealth) domain, researchers are increasingly discovering the opportunities of log data to assess the usage of their mobile apps. To date, however, the analysis of these data are often limited to descriptive statistics. Using data mining techniques, log data can offer significantly deeper insights. Objective: The purpose of this study was to assess how Markov Chain and sequence clustering analysis can be used to find meaningful usage patterns of mHealth apps. Methods: Using the data of a 25-day field trial (n=22) of the Start2Cycle app, an app developed to encourage recreational cycling in adults, a transition matrix between the different pages of the app was composed. From this matrix, a Markov Chain was constructed, enabling intuitive user behavior analysis. Results: Through visual inspection of the transitions, 3 types of app use could be distinguished (route tracking, gamification, and bug reporting). Markov Chain–based sequence clustering was subsequently used to demonstrate how clusters of session types can otherwise be obtained. Conclusions: Using Markov Chains to assess in-app navigation presents a sound method to evaluate use of mHealth interventions. The insights can be used to evaluate app use and improve user experience. %M 31237838 %R 10.2196/11934 %U https://www.jmir.org/2019/6/e11934/ %U https://doi.org/10.2196/11934 %U http://www.ncbi.nlm.nih.gov/pubmed/31237838 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 6 %P e13290 %T Outcomes and Device Usage for Fully Automated Internet Interventions Designed for a Smartphone or Personal Computer: The MobileQuit Smoking Cessation Randomized Controlled Trial %A Danaher,Brian G %A Tyler,Milagra S %A Crowley,Ryann C %A Brendryen,Håvar %A Seeley,John R %+ Prevention Science Institute, University of Oregon, 1600 Millrace Dr, Eugene, OR, 97403, United States, 1 5413464490, bdanaher@uoregon.edu %K tobacco %K smoking %K internet %K eHealth %K mHealth %K smartphone %K device %D 2019 %7 06.06.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Many best practice smoking cessation programs use fully automated internet interventions designed for nonmobile personal computers (desktop computers, laptops, and tablets). A relatively small number of smoking cessation interventions have been designed specifically for mobile devices such as smartphones. Objective: This study examined the efficacy and usage patterns of two internet-based best practices smoking cessation interventions. Methods: Overall, 1271 smokers who wanted to quit were randomly assigned to (1) MobileQuit (designed for—and constrained its use to—mobile devices, included text messaging, and embodied tunnel information architecture) or (2) QuitOnline (designed for nonmobile desktop or tablet computers, did not include text messages, and used a flexible hybrid matrix-hierarchical information architecture). Primary outcomes included self-reported 7-day point-prevalence smoking abstinence at 3- and 6-month follow-up assessments. Program visits were unobtrusively assessed (frequency, duration, and device used for access). Results: Significantly more MobileQuit participants than QuitOnline participants reported quitting smoking. Abstinence rates using intention-to-treat analysis were 20.7% (131/633) vs 11.4% (73/638) at 3 months, 24.6% (156/633) vs 19.3% (123/638) at 6 months, and 15.8% (100/633) vs 8.8% (56/638) for both 3 and 6 months. Using Complete Cases, MobileQuit’s advantage was significant at 3 months (45.6% [131/287] vs 28.4% [73/257]) and the combined 3 and 6 months (40.5% [100/247] vs 25.9% [56/216]) but not at 6 months (43.5% [156/359] vs 34.4% [123/329]). Participants in both conditions reported their program was usable and helpful. MobileQuit participants visited their program 5 times more frequently than did QuitOnline participants. Consistent with the MobileQuit’s built-in constraint, 89.46% (8820/9859) of its visits were made on an intended mobile device, whereas 47.72% (691/1448) of visits to QuitOnline used an intended nonmobile device. Among MobileQuit participants, 76.0% (459/604) used only an intended mobile device, 23.0% (139/604) used both mobile and nonmobile devices, and 0.1% (6/604) used only a nonmobile device. Among QuitOnline participants, 31.3% (137/438) used only the intended nonmobile devices, 16.7% (73/438) used both mobile and nonmobile devices, and 52.1% (228/438) used only mobile devices (primarily smartphones). Conclusions: This study provides evidence for optimizing intervention design for smartphones over a usual care internet approach in which interventions are designed primarily for use on nonmobile devices such as desktop computers, laptops. or tablets. We propose that future internet interventions should be designed for use on all of the devices (multiple screens) that users prefer. We forecast that the approach of designing internet interventions for mobile vs nonmobile devices will be replaced by internet interventions that use a single Web app designed to be responsive (adapt to different screen sizes and operating systems), share user data across devices, embody a pervasive information architecture, and complemented by text message notifications. Trial Registration: ClinicalTrials.gov NCT01952236; https://clinicaltrials.gov/ct2/show/NCT01952236 (Archived by WebCite at http://www.webcitation.org/6zdSxqbf8) %M 31172967 %R 10.2196/13290 %U https://www.jmir.org/2019/6/e13290/ %U https://doi.org/10.2196/13290 %U http://www.ncbi.nlm.nih.gov/pubmed/31172967 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 6 %P e13689 %T The Effectiveness of an App-Based Nurse-Moderated Program for New Mothers With Depression and Parenting Problems (eMums Plus): Pragmatic Randomized Controlled Trial %A Sawyer,Alyssa %A Kaim,Amy %A Le,Huynh-Nhu %A McDonald,Denise %A Mittinty,Murthy %A Lynch,John %A Sawyer,Michael %+ School of Public Health, University of Adelaide, Adelaide Health & Medical Sciences Building, 57 North Terrace, Mail Drop DX 650 550, Adelaide, 5005, Australia, 61 8 81617207, alyssa.sawyer@adelaide.edu.au %K mobile phone %K infant %K mother-child relations %K postnatal depression %K randomized controlled trial %D 2019 %7 04.06.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Postnatal depression and caregiving difficulties adversely affect mothers, infants, and later childhood development. In many countries, resources to help mothers and infants are limited. Online group–based nurse-led interventions have the potential to help address this problem by providing large numbers of mothers with access to professional and peer support during the postnatal period. Objective: This study tested the effectiveness of a 4-month online group–based nurse-led intervention delivered when infants were aged 2 to 6 months as compared with standard care outcomes. Methods: The study was a block randomized control trial. Mothers were recruited at the time they were contacted for the postnatal health check offered to all mothers in South Australia. Those who agreed to participate were randomly assigned to the intervention or standard care. The overall response rate was 63.3% (133/210). Primary outcomes were the level of maternal depressive symptoms assessed with the Edinburgh Postnatal Depression Scale (EPDS) and quality of maternal caregiving assessed using the Parenting Stress Index (PSI; competence and attachment subscales), the Parenting Sense of Competence Scale (PSCS), and the Nursing Child Assessment Satellite Training Scale. Assessments were completed at baseline (mean child age 4.9 weeks [SD 1.4]) and again when infants were aged 8 and 12 months. Results: Outcomes were evaluated using linear generalized estimating equations adjusting for postrandomization group differences in demographic characteristics and the outcome score at baseline. There were no significant differences in the intervention and standard care groups in scores on the PSI competence subscale (P=.69) nor in the PSCS (P=.11). Although the group by time interaction suggested there were differences over time between the EPDS and PSI attachment subscale scores in the intervention and standard care groups (P=.001 and P=.04, respectively), these arose largely because the intervention group had stable scores over time whereas the standard care group showed some improvements between baseline and 12 months. Mothers engaged well with the intervention with at least 60% (43/72) of mothers logging-in once per week during the first 11 weeks of the intervention. The majority of mothers also rated the intervention as helpful and user-friendly. Conclusions: Mothers reported that the intervention was helpful, and the app was described as easy to use. As such, it appears that support for mothers during the postnatal period, provided using mobile phone technology, has the potential to be an important addition to existing services. Possible explanations for the lack of differences in outcomes for the 2 groups in this study are the failure of many mothers to use key components of the intervention and residual differences between the intervention and standard care groups post randomization. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12616001732471; http://www.ANZCTR.org.au/ACTRN12616001732471.aspx (archived on WebCite as http://www.webcitation.org/77zo30GDw) %M 31165715 %R 10.2196/13689 %U https://www.jmir.org/2019/6/e13689/ %U https://doi.org/10.2196/13689 %U http://www.ncbi.nlm.nih.gov/pubmed/31165715 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 6 %N 5 %P e10778 %T A Group-Based Online Intervention to Prevent Postpartum Depression (Sunnyside): Feasibility Randomized Controlled Trial %A Duffecy,Jennifer %A Grekin,Rebecca %A Hinkel,Hannah %A Gallivan,Nicholas %A Nelson,Graham %A O'Hara,Michael W %+ Department of Psychiatry, College of Medicine, University of Illinois at Chicago, 912 S Wood, Chicago, IL, 60612, United States, 1 3124131225, jduffecy@gmail.com %K postpartum depression %K cognitive behavioral therapy %K internet %K social support %D 2019 %7 28.05.2019 %9 Original Paper %J JMIR Ment Health %G English %X Background: Postpartum depression (PPD) has a 20% 3-month prevalence rate. The consequences of PPD are significant for the mother, infant, and the family. There is a need for preventive interventions for PPD, which are effective and accessible; however, many barriers exist for women who attempt to access perinatal depression prevention programs. Internet interventions for the treatment and prevention of depression are widely accepted as efficacious and may overcome some of the issues pertaining to access to treatment barriers perinatal women face. However, internet interventions offered without any human support tend to have low adherence but positive outcomes for those who do complete treatment. Internet support groups often have high levels of adherence but minimal data supporting efficacy as a treatment for depression. Taken together, these findings suggest that combining the treatment components of individual interventions with the support provided by an internet support group might create an intervention with the scalability and cost-effectiveness of an individual intervention and the better outcomes typically found in supported interventions. Objectives: This study aimed to describe the development of a cognitive behavioral therapy (CBT) internet intervention with peer support to prevent PPD and examine preliminary depression and site usage outcomes. Methods: User-centered design groups were used to develop the internet intervention. Once the intervention was developed, women who were 20 to 28 weeks pregnant with symptoms of depression (Patient Health Questionnaire-8 scores of 5-14) but who had no major depression diagnosis were enrolled in a randomized controlled trial (RCT) to compare 8 weeks of a CBT-based internet intervention with peer support to an individual internet intervention designed to prevent PPD. Assessments took place at baseline, 4 weeks, 8 weeks (end of treatment), and then 4 weeks and 6 weeks postpartum. Results: A total of 25 women were randomized. Of these, 24 women completed the RCT. Patient Health Questionnaire-9 scores at 6 weeks postpartum remained below the clinical threshold for referral for treatment in both groups, with depression measures showing a decrease in symptoms from baseline to postpartum. At 6 weeks postpartum, only 4% (1/24) met the criteria for PPD. There was no difference between groups in adherence to the intervention, with an average of 14.55 log-ins over the course of treatment. Conclusions: Results suggest women were responsive to both peer support and individual internet interventions to prevent PPD and that peer support may be a useful feature to keep participants adherent. Trial Registration: ClinicalTrials.gov NCT02121015; https://clinicaltrials.gov/ct2/show/NCT02121015 (archived by WebCite at http://www.webcitation.org/765a7qBKy) %M 31140443 %R 10.2196/10778 %U http://mental.jmir.org/2019/5/e10778/ %U https://doi.org/10.2196/10778 %U http://www.ncbi.nlm.nih.gov/pubmed/31140443 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 5 %P e12965 %T A Mobile Lifestyle Management Program (GlycoLeap) for People With Type 2 Diabetes: Single-Arm Feasibility Study %A Koot,David %A Goh,Paul Soo Chye %A Lim,Robyn Su May %A Tian,Yubing %A Yau,Teng Yan %A Tan,Ngiap Chuan %A Finkelstein,Eric Andrew %+ Health Services and Systems Research, Duke-NUS Medical School, 8 College Road, Singapore,, Singapore, 65 6516 2338, eric.finkelstein@duke-nus.edu.sg %K type 2 diabetes mellitus %K self-management %K mobile health %K mHealth %K mobile phone app %K mobile apps %K health coaching %K blood glucose %K single-arm feasibility study %K RE-AIM %D 2019 %7 24.05.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Singapore’s current prevalence of diabetes exceeds 13.6%. Although lifestyle modification can be effective for reducing the risks for complications of type 2 diabetes mellitus (T2DM), traditional lifestyle interventions are often difficult to administer in the primary care setting due to limited resources. Mobile health apps can address these limitations by offering low-cost, adaptable, and accessible platforms for disseminating lifestyle management interventions. Objective: Using the RE-AIM evaluation framework, this study assessed the potential effectiveness and feasibility of GlycoLeap, a mobile lifestyle management program for people with T2DM, as an add-on to standard care. Methods: This single-arm feasibility study recruited 100 patients with T2DM and glycated hemoglobin (HbA1c) levels of ≥7.5% from a single community health care facility in Singapore. All participants were given access to a 6-month mobile lifestyle management program, GlycoLeap, comprising online lessons and the Glyco mobile phone app with a health coaching feature. The GlycoLeap program was evaluated using 4 relevant dimensions of the RE-AIM framework: (1) reach (percentage who consented to participate out of all patients approached), (2) effectiveness (percentage point change in HbA1c [primary outcome] and weight loss [secondary outcome]), (3) implementation (program engagement as assessed by various participatory metrics), and (4) maintenance (postintervention user satisfaction surveys to predict the sustainability of GlycoLeap). Participants were assessed at baseline and at follow-up (≥12 weeks after starting the intervention). Results: A total of 785 patients were approached of whom 104 consented to participate, placing the reach at 13.2%. Four were excluded after eligibility screening, and 100 patients were recruited. Program engagement (implementation) started out high but decreased with time for all evaluated components. Self-reported survey data suggest that participants monitored their blood glucose on more days in the past week at follow-up compared to baseline (P<.001) and reported positive changes to their diet due to app engagement (P<.001) (implementation). Primary outcome data were available for 83 participants. Statistically significant improvements were observed for HbA1c (–1.3 percentage points, P<.001) with greater improvements for those who logged their weight more often (P=.007) (effectiveness). Participants also had a 2.3% reduction in baseline weight (P<.001) (effectiveness). User satisfaction was high with 74% (59/80) and 79% (63/80) of participants rating the app good or very good and claiming that they would probably or definitely recommend the app to others, respectively (maintenance). Conclusions: Although measures of program engagement decreased with time, clinically significant improvements in HbA1c were achieved with the potential for broader implementation. However, we cannot rule out that these improvements were due to factors unrelated to GlycoLeap. Therefore, we would recommend evaluating the effectiveness and cost effectiveness of GlycoLeap using a randomized controlled trial of at least 12 months. Trial Registration: ClinicalTrials.gov NCT03091517; https://clinicaltrials.gov/ct2/show/NCT03091517 (Archived by WebCite at http://www.webcitation.org/77rNqhwRn) %M 31127720 %R 10.2196/12965 %U http://mhealth.jmir.org/2019/5/e12965/ %U https://doi.org/10.2196/12965 %U http://www.ncbi.nlm.nih.gov/pubmed/31127720 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 5 %P e12246 %T A Web-Based Cognitive Behavior Therapy Intervention to Improve Social and Occupational Functioning in Adults With Type 2 Diabetes (The SpringboarD Trial): Randomized Controlled Trial %A Clarke,Janine %A Sanatkar,Samineh %A Baldwin,Peter Andrew %A Fletcher,Susan %A Gunn,Jane %A Wilhelm,Kay %A Campbell,Lesley %A Zwar,Nicholas %A Harris,Mark %A Lapsley,Helen %A Hadzi-Pavlovic,Dusan %A Christensen,Helen %A Proudfoot,Judy %+ Black Dog Institute, Hospital Road, Randwick, Sydney,, Australia, 61 0293824521, p.baldwin@unsw.edu.au %K type 2 diabetes %K depression %K internet %D 2019 %7 21.05.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Depressive symptoms are common in people with type 2 diabetes mellitus (T2DM). Effective depression treatments exist; however, access to psychological support is characteristically low. Web-based cognitive behavioral therapy (CBT) is accessible, nonstigmatizing, and may help address substantial personal and public health impact of comorbid T2DM and depression. Objective: The aim of this study was to evaluate the Web-based CBT program, myCompass, for improving social and occupational functioning in adults with T2DM and mild-to-moderate depressive symptoms. myCompass is a fully automated, self-guided public health treatment program for common mental health problems. The impact of treatment on depressive symptoms, diabetes-related distress, anxiety symptoms, and self-care behavior was also examined. Methods: Participants with T2DM and mild-to-moderate depressive symptoms (N=780) were recruited online via Google and Facebook advertisements targeting adults with T2DM and via community and general practice settings. Screening, consent, and self-report scales were all self-administered online. Participants were randomized using double-blind computerized block randomization to either myCompass (n=391) for 8 weeks plus a 4-week tailing-off period or an active placebo intervention (n=379). At baseline and postintervention (3 months), participants completed the Work and Social Adjustment Scale, the primary outcome measure. Secondary outcome measures included the Patient Health Questionnaire-9 item, Diabetes Distress Scale, Generalized Anxiety Disorder Questionnaire-7 item, and items from the Self-Management Profile for Type 2 Diabetes. Results: myCompass users logged in an average of 6 times and completed an average of .29 modules. Healthy Lifestyles users logged in an average of 4 times and completed an average of 1.37 modules. At baseline, mean scores on several outcome measures, including the primary outcome of work and social functioning, were near to the normal range, despite an extensive recruitment process. Approximately 61.6% (473/780) of participants completed the postintervention assessment. Intention-to-treat analyses revealed improvement in functioning, depression, anxiety, diabetes distress, and healthy eating over time in both groups. Except for blood glucose monitoring and medication adherence, there were no specific between-group effects. Follow-up analyses suggested the outcomes did not depend on age, morbidity, or treatment engagement. Conclusions: Improvement in social and occupational functioning and the secondary outcomes was generally no greater for myCompass users than for users of the control program at 3 months postintervention. These findings should be interpreted in light of near-normal mean baseline scores on several variables, the self-selected study sample, and sample attrition. Further attention to factors influencing uptake and engagement with mental health treatments by people with T2DM, and the impact of illness comorbidity on patient conceptualization and experience of mental health symptoms, is essential to reduce the burden of T2DM. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12615000931572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368109&isReview=true (Archived by WebCite at http://www.webcitation.org/7850eg8pi) %M 31115345 %R 10.2196/12246 %U http://www.jmir.org/2019/5/e12246/ %U https://doi.org/10.2196/12246 %U http://www.ncbi.nlm.nih.gov/pubmed/31115345 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 5 %P e12201 %T A Digital Behavioral Weight Gain Prevention Intervention in Primary Care Practice: Cost and Cost-Effectiveness Analysis %A Krishnan,Anirudh %A Finkelstein,Eric Andrew %A Levine,Erica %A Foley,Perry %A Askew,Sandy %A Steinberg,Dori %A Bennett,Gary G %+ Program in Health Services and Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore, 65 66015470, anirudh.krishnan@duke-nus.edu.sg %K cost-effectiveness %K cost-benefit analysis %K obesity %K telemedicine %K women’s health %K minority health %K weight gain prevention %K weight gain %D 2019 %7 17.05.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Obesity is one of the largest drivers of health care spending but nearly half of the population with obesity demonstrate suboptimal readiness for weight loss treatment. Black women are disproportionately likely to have both obesity and limited weight loss readiness. However, they have been shown to be receptive to strategies that prevent weight gain. Objective: The aim of this study was to evaluate the costs and cost-effectiveness of a digital weight gain prevention intervention (Shape) for black women. Shape consisted of adaptive telephone-based coaching by health system personnel, a tailored skills training curriculum, and patient self-monitoring delivered via a fully automated interactive voice response system. Methods: A cost and cost-effectiveness analysis based on a randomized clinical trial of the Shape intervention was conducted from the payer perspective. Costs included those of delivering the program to 91 intervention participants in the trial and were summarized by program elements: self-monitoring, skills training, coaching, and administration. Effectiveness was measured in quality-adjusted life years (QALYs). The primary outcome was the incremental cost per QALY of Shape relative to usual care. Results: Shape cost an average of US $758 per participant. The base-case model in which quality of life benefits decay linearly to zero 5 years post intervention cessation, generated an incremental cost-effectiveness ratio (ICER) of US $55,264 per QALY. Probabilistic sensitivity analyses suggest an ICER below US $50,000 per QALY and US $100,000 per QALY in 39% and 98% of simulations, respectively. Results are highly sensitive to durability of benefits, rising to US $165,730 if benefits end 6 months post intervention. Conclusions: Results suggest that the Shape intervention is cost-effective based on established benchmarks, indicating that it can be a part of a successful strategy to address the nation’s growing obesity epidemic in low-income at-risk communities. %M 31102373 %R 10.2196/12201 %U http://www.jmir.org/2019/5/e12201/ %U https://doi.org/10.2196/12201 %U http://www.ncbi.nlm.nih.gov/pubmed/31102373 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 5 %P e11854 %T An Internet-Based Self-Testing Model (Easy Test): Cross-Sectional Survey Targeting Men Who Have Sex With Men Who Never Tested for HIV in 14 Provinces of China %A Jin,Xia %A Xu,Junjie %A Smith,M Kumi %A Xiao,Dong %A Rapheal,Erica R %A Xiu,Xiangfei %A Ding,Zhengwei %A Zhang,Yang %A Jie,Yang %A Liao,Ying %A Cao,Ningxiao %A Wu,Hao %A Bao,Yugang %+ AIDS Healthcare Foundation China Program, No.13, South Road of the 3rd Ring East, Chaoyang District, Beijing, 100021, China, 86 10 67735682, Yugang.Bao@aidshealth.org %K internet %K men who have sex with men (MSM) %K HIV %K China %D 2019 %7 15.05.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: With China’s explosive internet growth, activities such as socializing and partner seeking among men who have sex with men (MSM) has also become Web based through popular services such as Blued. This creates a new mode of health promotion with the potential to instantly reach large numbers of MSM, including those who rarely access traditional offline testing facilities. Objective: This study aimed to assess the feasibility of the Easy Test in increasing access and uptake of HIV testing and treatment services among MSM and to identify demographic and behavioral predictors of program uptake to inform future implementation. Methods: A feasibility study of the Easy Test model was conducted from October 2017 to December 2017 in 14 Chinese provinces. Applicants who provided informed consent completed a self-administered questionnaire and submitted a US $5 deposit to have the free test kit delivered to their homes. Orders were then received, processed, and posted by volunteers from local community-based organizations. Once applicants submitted images of their test results, the deposit was refunded to the applicant. Those whose test results were deemed to be HIV-positive were then connected to a peer navigator to accompany the individual to follow-up medical services. A chi-squared trend test was used to assess the relationship between lifetime HIV testing volume and HIV prevalence. Logistic regression models were used to identify independent risk factors associated with two outcomes: (1) never having tested for HIV and (2) receiving an HIV-positive result. Results: A total of 879 individuals submitted Web-based requests for test kits. Their median age was 28 (interquartile range 24-34 years); 69.3% (609/879) had at least a college education, and 51.5% (453/879) had a monthly income between US $450 to $750; 77.7% (683/879) of the applicants submitted images of their test results, among whom 14.3% (98/683) had an HIV-positive result. Among the 42.9% (293/683) who were first-time testers, the HIV prevalence was 18.8% (55/293). Nearly three-quarters (71/98, 72.4%) of those with a positive test result were connected with a peer navigator and enrolled in treatment. Among the first-time testers, having multiple sexual partners (2-3 sexual partners: adjusted odds ratio [aOR] 2.44, 95% CI 1.08-5.50; 4 or above sexual partners: aOR 3.55, 95% CI 1.18-10.68) and reporting inconsistent condom use in the previous 3 months (aOR 7.95, 95% CI 3.66-17.26) were both associated with an HIV-positive result. An inverse dose response relationship between lifetime HIV testing volume and HIV prevalence was also observed in this study (χ23=55.0; P<.001). Conclusions: The Easy Test model reached a larger portion of first-time testers, many who reported higher risk sexual behaviors. This highlights the potential for an internet-based self-test model to increase access to HIV treatment services for HIV-positive MSM in China. %M 31094339 %R 10.2196/11854 %U https://www.jmir.org/2019/5/e11854/ %U https://doi.org/10.2196/11854 %U http://www.ncbi.nlm.nih.gov/pubmed/31094339 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 6 %N 5 %P e10866 %T Economic Evaluation of an Internet-Based Stress Management Intervention Alongside a Randomized Controlled Trial %A Kählke,Fanny %A Buntrock,Claudia %A Smit,Filip %A Berking,Matthias %A Lehr,Dirk %A Heber,Elena %A Funk,Burkhardt %A Riper,Heleen %A Ebert,David Daniel %+ Institute for Psychology, Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, 2nd Floor, Nägelsbachstrasse 25a, Erlangen, 91052, Germany, 49 9131 85 ext 67568, fanny.kaehlke@fau.de %K work %K occupational stress %K economic evaluation %K internet %K quality of life %K clinical trials, randomized %D 2019 %7 15.05.2019 %9 Original Paper %J JMIR Ment Health %G English %X Background: Work-related stress is widespread among employees and associated with high costs for German society. Internet-based stress management interventions (iSMIs) are effective in reducing such stress. However, evidence for their cost-effectiveness is scant. Objective: The aim of this study was to assess the cost-effectiveness of a guided iSMI for employees. Methods: A sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale≥22) was assigned to either the iSMI or a waitlist control condition (WLC) with unrestricted access to treatment as usual. Participants were recruited in Germany in 2013 and followed through 2014, and data were analyzed in 2017. The iSMI consisted of 7 sessions plus 1 booster session. It was based on problem-solving therapy and emotion regulation techniques. Costs were measured from the societal perspective, including all direct and indirect medical costs. We performed a cost-effectiveness analysis and a cost-utility analysis relating costs to a symptom-free person and quality-adjusted life years (QALYs) gained, respectively. Sampling uncertainty was handled using nonparametric bootstrapping (N=5000). Results: When the society is not willing to pay anything to get an additional symptom-free person (eg, willingness-to-pay [WTP]=€0), there was a 70% probability that the intervention is more cost-effective than WLC. This probability rose to 85% and 93% when the society is willing to pay €1000 and €2000, respectively, for achieving an additional symptom-free person. The cost-utility analysis yielded a 76% probability that the intervention is more cost-effective than WLC at a conservative WTP threshold of €20,000 (US $25,800) per QALY gained. Conclusions: Offering an iSMI to stressed employees has an acceptable likelihood of being cost-effective compared with WLC. Trial Registration: German Clinical Trials Register DRKS00004749; https://www.drks.de/DRKS00004749 International Registered Report Identifier (IRRID): RR2-10.1186/1471-2458-13-655 %M 31094355 %R 10.2196/10866 %U https://mental.jmir.org/2019/5/e10866/ %U https://doi.org/10.2196/10866 %U http://www.ncbi.nlm.nih.gov/pubmed/31094355 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 3 %N 2 %P e12635 %T Treatment Preferences for Internet-Based Cognitive Behavioral Therapy for Insomnia in Japan: Online Survey %A Sato,Daisuke %A Sutoh,Chihiro %A Seki,Yoichi %A Nagai,Eiichi %A Shimizu,Eiji %+ Department of Cognitive Behavioral Physiology, Graduate School of Medicine, Chiba University, 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670, Japan, 81 43 226 2027, daisuke-sato@umin.ac.jp %K patient preference %K insomnia %K internet-based cognitive behavioral therapy %D 2019 %7 15.05.2019 %9 Original Paper %J JMIR Form Res %G English %X Background: The internet has the potential to increase individuals’ access to cognitive behavioral therapy (CBT) for insomnia at low cost. However, treatment preferences regarding internet-based computerized CBT for insomnia have not been fully examined. Objective: The aim was to conduct an anonymous online survey to evaluate treatment preferences for insomnia among patients with insomnia and individuals without insomnia. Methods: We developed an online survey to recruit a total of 600 participants living in the Kanto district in Japan. There were three subgroups: 200 medicated individuals with insomnia, 200 unmedicated individuals with insomnia, and 200 individuals without insomnia. The survey asked questions about the severity of the respondent’s insomnia (using the Athens Insomnia Scale), the frequency of sleep medication use and the level of satisfaction with sleep medication use, the respondent’s knowledge of CBT, his or her preference for CBT for insomnia before drug therapy, preference for CBT versus drug therapy, and preference for internet-based CBT versus face-to-face CBT. Results: Of the 600 respondents, 47.7% (286/600) indicated that they received CBT before drug therapy, and 57.2% (343/600) preferred CBT for insomnia to drug therapy. In addition, 47.0% (282/600) preferred internet-based CBT for insomnia to face-to-face CBT. Although the respondents with insomnia who were taking an insomnia medication had a relatively lower preference for internet-based CBT (40.5%, 81/200), the respondents with insomnia who were not taking an insomnia medication had a relatively higher preference for internet-based CBT (55.5%, 111/200). Conclusions: The results of our online survey suggest that approximately half of the people queried preferred CBT for insomnia to drug therapy, and half of the respondents preferred internet-based CBT for insomnia to face-to-face CBT. %M 31094319 %R 10.2196/12635 %U http://formative.jmir.org/2019/2/e12635/ %U https://doi.org/10.2196/12635 %U http://www.ncbi.nlm.nih.gov/pubmed/31094319 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 5 %P e13333 %T Remediating Reduced Autobiographical Memory in Healthy Older Adults With Computerized Memory Specificity Training (c-MeST): An Observational Before-After Study %A Martens,Kris %A Takano,Keisuke %A Barry,Tom J %A Goedleven,Jolien %A Van den Meutter,Louise %A Raes,Filip %+ Department of Psychology, The University of Hong Kong, Jockey Club Tower, Pokfulam Road, Hong Kong,, China, 86 3917 8927, tom.j.barry@icloud.com %K memory specificity training %K autobiographical memory %K cognitive aging %K online %K depression %K memory %K telemedicine %K rumination, cognitive %D 2019 %7 14.05.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: The ability to retrieve specific autobiographical memories decreases with cognitive aging. This decline is clinically relevant due to its association with impairments in problem solving, daily functioning, and depression. A therapist-delivered group training protocol, Memory Specificity Training (MeST), has been shown to enhance the retrieval of specific memories while ameliorating the impairments and negative outcomes associated with reduced specificity. The therapist-delivered nature of this intervention means it is relatively expensive to deliver and difficult for people with mobility impairments, such as older people, to receive. Objective: The objective of this study was to test if a novel, Web-based computerized version of a group training protocol called Memory Specificity Training, has the potential to increase autobiographical memory specificity and impact associated secondary psychological processes. Methods: A total of 21 participants (13 female; mean age 67.05, SD 6.55) who experienced a deficit in retrieving specific autobiographical memory were trained with c-MeST. We assessed memory specificity at preintervention and postintervention, as well as secondary processes such as depressive symptoms, rumination, and problem-solving skills. Results: Memory specificity increased significantly after participants completed c-MeST (r=.57). Session-to-session scores indicated that autobiographical memory specificity improved most from the online baseline assessment to the first Web-based session. Symptoms or secondary processes such as problem-solving skills did not change significantly. Conclusions: A Web-based automated individual version of MeST is a feasible, low-cost intervention for reduced memory specificity in healthy older adults. Future studies should clarify the preventive impact of c-MeST in other at-risk sample populations with longer follow-up times. %M 31094362 %R 10.2196/13333 %U https://www.jmir.org/2019/5/e13333/ %U https://doi.org/10.2196/13333 %U http://www.ncbi.nlm.nih.gov/pubmed/31094362 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 5 %P e11349 %T Reducing Stress and Preventing Depression (RESPOND): Randomized Controlled Trial of Web-Based Rumination-Focused Cognitive Behavioral Therapy for High-Ruminating University Students %A Cook,Lorna %A Mostazir,Mohammod %A Watkins,Edward %+ SMART Lab, Mood Disorders Centre, School of Psychology, University of Exeter, Sir Henry Wellcome Building for Mood Disorders Research, Queens Drive, Exeter, EX4 4QG, United Kingdom, 44 (0) 139272 ext 4692, E.R.Watkins@exeter.ac.uk %K cognitive behavioral therapy %K depression %K prevention %K rumination, cognitive %K stress, psychological %K student health services %D 2019 %7 13.05.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Prevention of depression is a priority to reduce its global disease burden. Targeting specific risk factors, such as rumination, may improve prevention. Rumination-focused Cognitive Behavioral Therapy (RFCBT) was developed to specifically target depressive rumination. Objective: The primary objective of this study was to test whether guided Web-based RFCBT (i-RFCBT) would prevent the incidence of major depression relative to usual care in UK university students. The secondary objective was to test the feasibility and estimated effect sizes of unguided i-RFCBT. Methods: To address the primary objective, a phase III randomized controlled trial was designed and powered to compare high risk university students (N=235), selected with elevated worry/rumination, recruited via an open access website in response to circulars within universities and internet advertisements, randomized to receive either guided i-RFCBT (interactive Web-based RFCBT, supported by asynchronous written Web-based support from qualified therapists) or usual care control. To address the secondary objective, participants were also randomized to an adjunct arm of unguided (self-administered) i-RFCBT. The primary outcome was the onset of a major depressive episode over 15 months, assessed with structured diagnostic interviews at 3 (postintervention), 6, and 15 months post randomization, conducted by telephone, blind to the condition. Secondary outcomes of symptoms of depression and anxiety and levels of worry and rumination were self-assessed through questionnaires at baseline and the same follow-up intervals. Results: Participants were randomized to guided i-RFCBT (n=82), unguided i-RFCBT (n=76), or usual care (n=77). Guided i-RFCBT reduced the risk of depression by 34% relative to usual care (hazard ratio [HR] 0.66, 95% CI 0.35 to 1.25; P=.20). Participants with higher levels of baseline stress benefited most from the intervention (HR 0.43, 95% CI 0.21 to 0.87; P=.02). Significant improvements in rumination, worry, and depressive symptoms were found in the short-to-medium term. Of the 6 modules, guided participants completed a mean of 3.46 modules (SD 2.25), with 46% (38/82) being compliant (completing ≥4 modules). Similar effect sizes and compliance rates were found for unguided i-RFCBT. Conclusions: Guided i-RFCBT can reduce the onset of depression in high-risk young people reporting high levels of worry/rumination and stress. The feasibility study argues for formally testing unguided i-RFCBT for prevention: if the observed effect sizes are robustly replicated in a phase III trial, it has potential as a scalable prevention intervention. Trial Registration: ISRCTN Registry ISRCTN12683436; https://www.isrctn.com/ISRCTN12683436 (Archived by WebCite at http://www.webcitation.org/77fqycyBX) International Registered Report Identifier (IRRID): RR2-10.1186/s13063-015-1128-9 %M 31094331 %R 10.2196/11349 %U https://www.jmir.org/2019/5/e11349/ %U https://doi.org/10.2196/11349 %U http://www.ncbi.nlm.nih.gov/pubmed/31094331 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 6 %N 2 %P e12700 %T Creating an mHealth App for Colorectal Cancer Screening: User-Centered Design Approach %A Griffin,Lauren %A Lee,Donghee %A Jaisle,Alyssa %A Carek,Peter %A George,Thomas %A Laber,Eric %A Lok,Benjamin %A Modave,François %A Paskett,Electra %A Krieger,Janice %+ STEM Translational Communication Center, University of Florida, Weimer Hall, University of Florida, Gainesville, FL, 32611, United States, 1 2198053886, lngriffin@ufl.edu %K communication %K cell phone %K mobile phone %K culturally appropriate technology %K interdisciplinary research %K colon cancer %K cancer screening %D 2019 %7 08.05.2019 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Patients are increasingly using mobile health (mHealth) apps to monitor their health and educate themselves about medical issues. Despite the increasing popularity of such apps, poor design and usability often lead to suboptimal continued use of these apps and subsequently to poor adherence to the behavior changes at which they are aimed. One solution to these design problems is for app developers to use user-centered design (UCD) principles to consider the context and needs of users during the development process. Objective: This study aimed to present a case study on the design and development process for an mHealth app that uses virtual human technology (VHT) to encourage colorectal cancer (CRC) screening among patients aged 50 years and above. Methods: We have first provided an overview of the project and discussed its utilization of VHT. We have then reviewed UCD principles and how they can be incorporated into the development of health apps. We have described how we used UCD processes during the app’s development. We have then discussed the unique roles played by communication researchers, computer scientists, clinicians, and community participants in creating an mHealth app that is credible, usable, effective, and accessible to its target audience. Results: The principles of UCD were woven throughout the project development, with researchers collecting feedback from patients and providers at all stages and using that feedback to improve the credibility, usability, effectiveness, and accessibility of the mHealth app. The app was designed in an iterative process, which encouraged feedback and improvement of the app and allowed teams from different fields to revisit topics and troubleshoot problems. Conclusions: Implementing a UCD process contributed to the development of an app, which not only reflected cross-disciplinary expertise but also the needs, wants, and concerns of patients. %M 31066688 %R 10.2196/12700 %U http://humanfactors.jmir.org/2019/2/e12700/ %U https://doi.org/10.2196/12700 %U http://www.ncbi.nlm.nih.gov/pubmed/31066688 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 5 %P e10354 %T Qualitative Interview Studies of Working Mechanisms in Electronic Health: Tools to Enhance Study Quality %A Holter,Marianne TS %A Johansen,Ayna B %A Ness,Ottar %A Brinkmann,Svend %A Høybye,Mette T %A Brendryen,Håvar %+ Norwegian Centre for Addiction Research (SERAF), Institute of Clinical Medicine, University of Oslo, Postboks 1039 Blindern, Oslo, 0315, Norway, 47 93623061, marianne.holter@protonmail.com %K telemedicine %K eHealth %K mobile health %K telehealth %K mHealth %K interviews as topic %K health care evaluation mechanisms %K data collection %D 2019 %7 06.05.2019 %9 Viewpoint %J J Med Internet Res %G English %X Future development of electronic health (eHealth) programs (automated Web-based health interventions) will be furthered if program design can be based on the knowledge of eHealth’s working mechanisms. A promising and pragmatic method for exploring potential working mechanisms is qualitative interview studies, in which eHealth working mechanisms can be explored through the perspective of the program user. Qualitative interview studies are promising as they are suited for exploring what is yet unknown, building new knowledge, and constructing theory. They are also pragmatic, as the development of eHealth programs often entails user interviews for applied purposes (eg, getting feedback for program improvement or identifying barriers for implementation). By capitalizing on these existing (applied) user interviews to also pursue (basic) research questions of how such programs work, the knowledge base of eHealth’s working mechanisms can grow quickly. To be useful, such interview studies need to be of sufficient quality, which entails that the interviews should generate enough data of sufficient quality relevant to the research question (ie, rich data). However, getting rich interview data on eHealth working mechanisms can be surprisingly challenging, as several of the authors have experienced. Moreover, when encountering difficulties as we did, there are few places to turn to, there are currently no guidelines for conducting such interview studies in a way that ensure their quality. In this paper, we build on our experience as well as the qualitative literature to address this need, by describing 5 challenges that may arise in such interviews and presenting methodological tools to counteract each challenge. We hope the ideas we offer will spark methodological reflections and provide some options for researchers interested in using qualitative interview studies to explore eHealth’s working mechanisms. %M 31066683 %R 10.2196/10354 %U https://www.jmir.org/2019/5/e10354/ %U https://doi.org/10.2196/10354 %U http://www.ncbi.nlm.nih.gov/pubmed/31066683 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 5 %P e13415 %T Web-Based Interventions to Improve Mental Health in Home Caregivers of People With Dementia: Meta-Analysis %A Zhao,Yinan %A Feng,Hui %A Hu,Mingyue %A Hu,Hengyu %A Li,Hui %A Ning,Hongting %A Chen,Huijing %A Liao,Lulu %A Peng,Linlin %+ Xiangya School of Nursing, Central South University, No 172 Tongzipo Road, Changsha,, China, 86 82650292, feng.hui@csu.edu.cn %K internet %K education %K mental health %K caregivers %K dementia %D 2019 %7 6.5.2019 %9 Review %J J Med Internet Res %G English %X Background: Dementia is a major cause of disability and dependency in older adults worldwide. It is often accompanied by general psychological distress, such as depression and anxiety symptoms, among caregivers of people with dementia (PwD). The physical and mental health of the caregiver is a prerequisite and a promise to help PwD continue to live as long and as well as possible. Web-based interventions can provide convenient and efficient support and an education tool to potentially reduce the negative outcomes associated with providing care. Objective: The aim of this study was to examine the effect of internet-based interventions on the mental health outcomes of family caregivers of PwD and to explore which components of the Web-based interventions play an important role. Methods: A comprehensive literature search was conducted in PubMed, Excerpta Medica dataBASE, PsycINFO, Cochrane Database, and the Cumulative Index to Nursing and Allied Health Literature using relevant terms such as Web-based and caregiver as keywords, covering all studies published before June 2018. A total of 2 reviewers independently reviewed all published abstracts, according to established inclusion and exclusion criteria. We extracted information about the participants, interventions, and results and reviewed article quality in terms of the randomized trial methods, using the approach recommended by the Cochrane Handbook for Systematic Reviews of Interventions. Results: A total of 815 caregivers participated in 6 studies, with 4 of the studies using depression as an outcome. The analysis found that depression scores dropped an average of 0.23 (95% CI −0.38 to −0.07; P<.01) after Web-based interventions. In 2 studies of caregivers who were experiencing anxiety symptoms, the average score for anxiety dropped by 0.32 points (95% CI −0.50 to −0.14; P<.01). However, in terms of coping, pain, and stress, the Web-based interventions showed a poor effect. On the whole, the addition of professional psychological support on the basis of education can improve caregivers’ mental health. Conclusions: Internet-based interventions were generally effective at reducing anxiety and depression in dementia caregivers, although negative results were found in some studies. As for burden and stress, further research is required. %M 31066680 %R 10.2196/13415 %U http://www.jmir.org/2019/5/e13415/ %U https://doi.org/10.2196/13415 %U http://www.ncbi.nlm.nih.gov/pubmed/31066680 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 5 %P e11860 %T Effects, Adherence, and Therapists’ Perceptions of Web- and Mobile-Supported Group Therapy for Depression: Mixed-Methods Study %A Schuster,Raphael %A Kalthoff,Inanna %A Walther,Alexandra %A Köhldorfer,Lena %A Partinger,Edith %A Berger,Thomas %A Laireiter,Anton-Rupert %+ Center for Clinical Psychology, Psychotherapy and Health Psychology, Department of Psychology, University of Salzburg, Hellbrunnerstraße 34, Salzburg, 5020, Austria, 43 6644156146, raphael.schuster@stud.sbg.ac.at %K eHealth %K mobile phone %K computer-assisted therapy %K monitoring %K group therapy %K depression %K professional-patient relations %D 2019 %7 06.05.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Blended group therapy (bGT) has been investigated a several times for anxiety and depression, but information on patients’ adherence to and therapists’ perception of the novel format is nonexistent. Furthermore, many studies investigated mainly female and highly educated populations, limiting the validity of previous findings. Objective: This study aimed to reduce the gaps and limitations of the previous findings by evaluating an integrated internet- and mobile-supported bGT format. Methods: A total of 27 patients diagnosed with major depression (14/27, 52% female and 7/27, 25.9% compulsory education) participated in a 7-week treatment at a university outpatient clinic. Furthermore, 8 novice therapists participated in semistructured interviews and a subsequent cross-validation survey. Results: Primary symptom reduction was high (d=1.31 to 1.51) and remained stable for the follow-up period. Therapists identified advantages (eg, patient engagement, treatment intensification, and improved therapeutic relation) and disadvantages (eg, increased workload, data issues, and undesired effects) of bGT. The required online guidance time was 10.3 min per patient and week, including guidance on exercises (67% or 6.9 min) and intimate communication (33% or 3.4 min). Concerning patients’ adherence to bGT, tracked completion of all Web-based and mobile tasks was high and comparable with group attendance. Conclusions: Results suggest high feasibility of bGT in a gender-balanced, moderately educated sample. bGT provides group therapists with tools for individual care, resulting in an optimization of the therapy process, and high completion rates of the implemented bGT elements. The limited work experience of the involved therapists restricts the study findings, and potential drawbacks need to be regarded in the development of future bGT interventions. %M 31066700 %R 10.2196/11860 %U https://www.jmir.org/2019/5/e11860/ %U https://doi.org/10.2196/11860 %U http://www.ncbi.nlm.nih.gov/pubmed/31066700 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 5 %P e13183 %T Development and Evaluation of a Web-Based Resource for Suicidal Thoughts: NowMattersNow.org %A Whiteside,Ursula %A Richards,Julie %A Huh,David %A Hidalgo,Rianna %A Nordhauser,Rebecca %A Wong,Albert J %A Zhang,Xiaoshan %A Luxton,David D %A Ellsworth,Michael %A Lezine,DeQuincy %+ NowMattersNow.org, 2331 E Madison St, Seattle, WA, 98112, United States, 1 206 679 6349, ursulawhiteside@gmail.com %K dialectical behavior therapy %K suicide %K internet %K help-seeking behavior %K behavior therapy %K crisis intervention %K primary care %K integrated health care systems %D 2019 %7 02.05.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Nearly half of people who die by suicide see a health care provider in the month before their death. With the release of new care guidelines, detection of suicidal patients will likely increase. Providers need access to suicide-specific resources that can be used as part of immediate, brief interventions with a suicidal patient. Web-based suicide prevention resources have the potential to address this need. Objective: This study aimed to describe the development of the NowMattersNow.org website as a resource for individuals with suicidal thoughts and to evaluate the utility of the site via user experience surveys. Methods: NowMattersNow.org is an online video-based free public resource that provides evidence-based teachings, examples, and resources for managing suicidal thoughts and intense emotions focused largely around skills from dialectical behavior therapy. Developed with assistance from mental health consumers, it is intended to address gaps in access to services for suicidal patients in health care systems. Visitors stay an average of a minute and a half on the website. From March 2015 to December 2017, a user experience survey measured self-reported changes on a 1 (not at all) to 5 (completely overwhelming) scale regarding intensity of suicidal thoughts and negative emotions while on the website. Longitudinal regression analyses using generalized estimating equations evaluated the magnitude and statistical significance of user-reported changes in suicidal ideation and negative emotion. In secondary analyses, user-reported changes specific to subgroups, including men aged 36 to 64 years, mental health care providers, and other health care providers were evaluated. Results: During the period of analysis, there were 138,386 unique website visitors. We analyzed surveys (N=3670) collected during that time. Subsamples included men aged 36 to 64 years (n=512), mental health providers (n=460), and other health care providers (n=308). A total of 28% (1028/3670) of survey completers rated their suicidal thoughts as a 5 or “completely overwhelming” when they entered the website. We observed significant reductions in self-reported intensity of suicidal thoughts (–0.21, P<.001) and negative emotions (–0.32, P<.001), including decreases for users with the most severe suicidal thoughts (–6.4%, P<.001), most severe negative emotions (–10.9%, P<.001), and for middle-aged men (–0.13, P<001). Results remained significant after controlling for length of visit to website (before the survey) and technology type (mobile, desktop, and tablet). Conclusions: Survey respondents reported measurable reductions in intensity of suicidal thoughts and emotions, including those rating their suicidal thoughts as completely or almost completely overwhelming and among middle-aged men. Although results from this user-experience survey administered at one point in time to a convenience sample of users must be interpreted with caution, results provide preliminary support for the potential effectiveness of the NowMattersNow.org website as a tool for short-term management of suicidal thoughts and negative emotions. %M 31045498 %R 10.2196/13183 %U http://www.jmir.org/2019/5/e13183/ %U https://doi.org/10.2196/13183 %U http://www.ncbi.nlm.nih.gov/pubmed/31045498 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 4 %P e12463 %T Efficacy of a Web-Based Self-Management Enhancing Program for Patients with Rheumatoid Arthritis: Explorative Randomized Controlled Trial %A Zuidema,Rixt %A van Dulmen,Sandra %A Nijhuis-van der Sanden,Maria %A Meek,Inger %A van den Ende,Cornelia %A Fransen,Jaap %A van Gaal,Betsie %+ Scientific Institute for Quality of Healthcare, Radboud Institute for Health Sciences, Radboud University Medical Center, Postbus 9101, Huispost 114, Nijmegen, PO Box 9101, 6500, Netherlands, 31 2436 5567, rixt.zuidema@radboudumc.nl %K self-management %K internet %K arthritis, rheumatoid %D 2019 %7 30.04.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based self-management enhancing programs have the potential to support patients with rheumatoid arthritis (RA) in their self-management; for example, improve their health status by increasing their self-efficacy or taking their prescribed medication. We developed a Web-based self-management enhancing program in collaboration with RA patients and professionals as co-designers on the basis of the intervention mapping framework. Although self-management programs are complex interventions, it is informative to perform an explorative randomized controlled trial (RCT) before embarking on a larger trial. Objective: This study aimed to evaluate the efficacy of a Web-based self-management enhancing program for patients with RA and identify outcome measures most likely to capture potential benefits. Methods: A multicenter exploratory RCT was performed with an intervention group and a control group. Both groups received care as usual. In addition, the intervention group received 12 months of access to a Web-based self-management program. Assessment occurred at baseline, 6 months, and 12 months. Outcome measures included self-management behavior (Patient Activation Measurement, Self-Management Ability Scale), self-efficacy (Rheumatoid Arthritis task-specific Self-Efficacy, Perceived Efficacy in Patient-Physician Interaction), general health status (RAND-36), focus on fatigue (Modified Pain Coping Inventory for Fatigue), and perceived pain and fatigue (Numeric Rating Scales). A linear mixed model for repeated measures, using the intention-to-treat principle, was applied to study differences between the patients in the intervention (n=78) and control (n=79) groups. A sensitivity analysis was performed in the intervention group to study the influence of patients with high (N=30) and low (N=40) use of the intervention. Results: No positive effects were found regarding the outcome measurements. Effect sizes were low. Conclusions: Based on these results, it is not possible to conclude on the positive effects of the intervention or to select outcome measures to be regarded as the primary/main or secondary outcomes for a future trial. A process evaluation should be performed to provide more insight into the low compliance with and effectiveness of the intervention. This can determine for whom this sort of program will work and help to fine-tune the inclusion criteria. Trial Registration: Netherlands Trial Register NTR4871; https://www.trialregister.nl/trial/4726 %M 31038461 %R 10.2196/12463 %U https://www.jmir.org/2019/4/e12463/ %U https://doi.org/10.2196/12463 %U http://www.ncbi.nlm.nih.gov/pubmed/31038461 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 4 %P e10830 %T “It’s Not Just Technology, It’s People”: Constructing a Conceptual Model of Shared Health Informatics for Tracking in Chronic Illness Management %A Vizer,Lisa M %A Eschler,Jordan %A Koo,Bon Mi %A Ralston,James %A Pratt,Wanda %A Munson,Sean %+ Division of General Medicine and Clinical Epidemiology, School of Medicine, University of North Carolina at Chapel Hill, Health Sciences Library, Rm 333A, CB 7110, 335 S Columbia St, Chapel Hill, NC, 27599-7110, United States, 1 4109082774, LMVizer@unc.edu %K consumer health informatics %K chronic illness %K patient generated health data %K patient reported outcomes %K workflow %K information seeking behavior %K shared decision making %D 2019 %7 29.04.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: For many people, tracking health indicators is central to managing a chronic illness. However, previous informatics research has largely viewed tracking as a solitary process that lacks the characteristics essential to tracking in support of chronic illness management. Objective: To inform development of effective technologies that aid tracking of health indicators to support chronic illness management, this study aimed to construct a health informatics model that accurately describes the work and social context of that tracking work. Methods: As part of a larger project, we conducted semistructured interviews with 40 adults concerning their chronic illness management practices, including tracking and communication. We also assembled transcripts of 30 publicly available videos of 24 adults discussing tracking processes for managing their own chronic illness. We used qualitative methods to analyze interviews and video transcripts through the lens of ongoing personal and health informatics research. Results: We have described the people and work involved in tracking in support of chronic illness management and contributed a Conceptual Model of Shared Health Informatics (CoMSHI). Specifically, we identified the need for a health informatics model that (1) incorporates the ongoing nature of tracking work and (2) represents the social dimension of tracking for illness management. Our model depicts communication, information, collection, integration, reflection, and action work in the social context of the person with chronic illness, informal carers, health care providers, and community members. Conclusions: The resulting CoMSHI yields a more detailed and nuanced viewpoint of tracking in support of chronic illness management and can inform technology design to improve tracking tools to support people in more confident and capable chronic illness management. %M 31033452 %R 10.2196/10830 %U http://www.jmir.org/2019/4/e10830/ %U https://doi.org/10.2196/10830 %U http://www.ncbi.nlm.nih.gov/pubmed/31033452 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 4 %P e11829 %T Developing a Sexual Health Promotion Intervention With Young Men in Prisons: A Rights-Based Participatory Approach %A Templeton,Michelle %A Kelly,Carmel %A Lohan,Maria %+ Queen's University Belfast, School of Nursing and Midwifery, Medical Biology Centre, Belfast, BT97BL, United Kingdom, 44 (0) 28 90 97 ext 2233, m.templeton@qub.ac.uk %K sexual health %K male %K prison %K health promotion %K rights-based participation %D 2019 %7 29.04.2019 %9 Original Paper %J JMIR Res Protoc %G English %X Background: The sexual health of young men in prisons is often among the poorest in any given country. They may have developed sexual behaviors that, from a public health perspective, are considered problematic and burdensome. These include poorer use of condoms and engaging in more frequent casual sex, resulting in higher rates of sexually transmitted infections, including HIV and viral hepatitis. Thus, young incarcerated men are a highly marginalized and socially excluded high-risk group, in greater need of sexual health education and services. Objective: The aim of this study was to create an innovative sexual health promotion intervention, made for and with young men in prisons, to encourage them to avail of regular sexual health checkups. This included developing a Web-based animated-style sexual health promotion intervention (1.42 min) coupled with upskilling the prison nurses to offer a partnership approach to prison health care. This paper focuses on the development of the intervention and the importance of the underpinning rights-based (RB) participatory intervention design. Methods: We employed an RB participatory approach and recruited 14 participants who attended 3 coproduction workshops held within a prison site in Northern Ireland, United Kingdom. A bespoke 3-day training for nurses beforehand, ensured they gained a deeper understanding of the determinants of poor sexual health. The coproduction team comprised young men, prison nurses, nurse sexual health consultant, media company representatives, and facilitator. Workshops focused on content, design, tone and medium of communication for a Web-based intervention that would be appealing and engaging for young incarcerated men. Results: A 1.42-min animation Dick loves Doot was created to promote a positive attitude toward sexual health checkups. The RB approach enabled the young men to participate, have their voices heard and see their stories reflected through the animation. The nurses’ capacities to protect, fulfill, and respect the young men’s rights to appropriate sexual health services and education was also enhanced. Evaluations confirmed that we successfully provided accurate sexual health information in a way that was engaging and accessible and that encouraged the young men to avail of the new prison sexual health services that were set up in the prison and now provided by nurses. Conclusions: The RB participatory approach to health advanced in this study provided a means to (1) gain invaluable insider knowledge to understand the impact of structural determinants on health and health inequalities and strategies by which to target young incarcerated men (2) create inclusive opportunities for developing bespoke targeted interventions, and (3) galvanize collaborative partnerships to disrupt the structures and processes that lead to and encourage health inequities. To reduce future risk, effective treatment, coupled with coproduced interventions that transmit relevant health messages in a relevant and meaningful way, is key to success. %M 31033447 %R 10.2196/11829 %U https://www.researchprotocols.org/2019/4/e11829/ %U https://doi.org/10.2196/11829 %U http://www.ncbi.nlm.nih.gov/pubmed/31033447 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 6 %N 4 %P e11401 %T Evaluating the Feasibility of an Innovative Self-Confidence Webinar Intervention for Depression in the Workplace: A Proof-of-Concept Study %A Wan Mohd Yunus,Wan Mohd Azam %A Musiat,Peter %A Brown,June SL %+ Department of Psychology, School of Human Resource Development and Psychology, Faculty of Social Sciences and Humanities, Universiti Teknologi Malaysia, UTM Johor Bahru, Skudai, Johor, 81310, Malaysia, 60 176136163, azam.yunus@kcl.ac.uk %K online %K videoconferencing %K cognitive behavioral therapy %K depression %K workplace %D 2019 %7 26.04.2019 %9 Original Paper %J JMIR Ment Health %G English %X Background: Depression in the workplace is a very common problem that exacerbates employees’ functioning and consequently influences the productivity of organizations. Despite the commonness of the problem and the currently available interventions, a high proportion of employees do not seek help. A new intervention, a webinar (Web-based seminar), was developed, which integrated the use of technology and the traditional guided therapist support to provide accessible help for the problem of depression in the workplace. Objective: The aim of this study was to explore the feasibility, preliminary outcome, and acceptability of the webinar intervention conducted in organizations. Methods: In total, 2 organizations were invited to participate, and 33 employees participated in this proof-of-concept study. The webinar intervention consisted of 6 1-hour sessions conducted via the Adobe Connect platform, developed by Adobe Inc. The intervention was developed based on a systematic review, focus group studies, and face-to-face self-confidence workshops that utilized cognitive behavior therapy (CBT). The final webinar intervention used CBT and the coping flexibility approach. The structure of the intervention included PowerPoint presentations, animation videos, utilization of chat panels, and whiteboard features. The intervention was conducted live and guided by a consultant psychologist assisted by a moderator. Study outcomes were self-assessed using self-reported Web surveys. The acceptability of the intervention was assessed using self-reported user experience Web surveys and open-ended questions. Results: The findings showed: (1) evidence of feasibility of the intervention: the webinar intervention was successfully conducted in 3 groups, with 6 1-hour sessions for each group, with 82% (23/28) participants completing all 6 sessions; (2) positive improvements in depression: the linear mixed effects modeling analysis recorded a significant overall effect of time primarily for depression (F2, 48.813=31.524; P<.001) with a Hedge g effect size of 0.522 at 1-month follow-up. Individually, 8 subjects showed significant reliable and clinically significant changes, with 3 subjects showing clinically significant change only; and (3) encouraging evidence regarding the acceptability of the webinar intervention among the employees: the user experience score was above average for 4 out of 6 domains measured (perspicuity mean 1.198 [95% CI 0.832-1.564], efficiency mean 1.000 [95% CI 0.571-1.429], dependability mean 1.208 [95% CI 0.899-1.517], and stimulation mean 1.323 [95% CI 0.987-1.659]). The open-ended questions also yielded 52% (47/91) of the responses that reported facilitators, whereas only 12% (11/91) of the responses reported barriers. Conclusions: The self-confidence webinar intervention appears to be a potentially feasible, effective, and acceptable intervention for depression in the workplace that merits further investigation. %M 31025943 %R 10.2196/11401 %U http://mental.jmir.org/2019/4/e11401/ %U https://doi.org/10.2196/11401 %U http://www.ncbi.nlm.nih.gov/pubmed/31025943 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 4 %P e11394 %T Predicting Outcomes from Engagement With Specific Components of an Internet-Based Physical Activity Intervention With Financial Incentives: Process Analysis of a Cluster Randomized Controlled Trial %A Murray,Jennifer M %A French,David P %A Patterson,Christopher C %A Kee,Frank %A Gough,Aisling %A Tang,Jianjun %A Hunter,Ruth F %+ Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Institute of Clinical Science B, Royal Victoria Hospital, Grosvenor Road, Belfast, BT12 6BJ, United Kingdom, 44 2890978955, Jennifer.Murray@qub.ac.uk %K physical activity %K workplace %K randomized controlled trial %K behavior %K maintenance %K motivation %D 2019 %7 19.04.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Investigating participant engagement and nonusage attrition can help identify the likely active ingredients of electronic health interventions. Research on engagement can identify which intervention components predict health outcomes. Research on nonusage attrition is important to make recommendations for retaining participants in future studies. Objective: This study aimed to investigate engagement and nonusage attrition in the Physical Activity Loyalty (PAL) scheme, a 6-month complex physical activity intervention in workplaces in Northern Ireland. The intervention included financial incentives with reward redemption and self-regulation techniques. Specific objectives were (1) to determine whether engagement in specific intervention components predicted physical activity at 6 months, (2) to determine whether engagement in specific intervention components predicted targeted mediators at 6 months, and (3) to investigate predictors of nonusage attrition for participants recording daily activity via the PAL scheme physical activity monitoring system and logging onto the website. Methods: Physical activity was assessed at baseline and 6 months using pedometers (Yamax Digiwalker CW-701, Japan). Markers of engagement and website use, monitoring system use, and reward redemption were collected throughout the scheme. Random-effects generalized least-squares regressions determined whether engagement with specific intervention components predicted 6-month physical activity and mediators. Cox proportional hazards regressions were used to investigate predictors of nonusage attrition (days until first 2-week lapse). Results: A multivariable generalized least-squares regression model (n=230) showed that the frequency of hits on the website’s monitoring and feedback component (regression coefficient [b]=50.2; SE=24.5; P=.04) and the percentage of earned points redeemed for financial incentives (b=9.1; SE=3.3; P=.005) were positively related to 6-month pedometer steps per day. The frequency of hits on the discussion forum (b=−69.3; SE=26.6; P=.009) was negatively related to 6-month pedometer steps per day. Reward redemption was not related to levels of more internal forms of motivation. Multivariable Cox proportional hazards regression models identified several baseline predictors associated with nonusage attrition. These included identified regulation (hazard ratio [HR] 0.88, 95% CI 0.81-0.97), recovery self-efficacy (HR 0.88, 95% CI 0.80-0.98), and perceived workplace environment safety (HR 1.07, 95% CI 1.02-1.11) for using the physical activity monitoring system. The EuroQoL health index (HR 0.33, 95% CI 0.12-0.91), financial motivation (HR 0.93, 95% CI 0.87-0.99), and perceived availability of physical activity opportunities in the workplace environment (HR 0.96, 95% CI 0.93-0.99) were associated with website nonusage attrition. Conclusions: Our results provide evidence opposing one of the main hypotheses of self-determination theory by showing that financial rewards are not necessarily associated with decreases in more internal forms of motivation when offered as part of a complex multicomponent intervention. Identifying baseline predictors of nonusage attrition can help researchers to develop strategies to ensure maximum intervention adherence. Trial Registration: ISRCTN Registry ISRCTN17975376; http://www.isrctn.com/ISRCTN17975376 (Archived by WebCite at http://www.webcitation.org/76VGZsZug) %M 31002304 %R 10.2196/11394 %U https://www.jmir.org/2019/4/e11394/ %U https://doi.org/10.2196/11394 %U http://www.ncbi.nlm.nih.gov/pubmed/31002304 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 4 %P e13281 %T Integration of Rehabilitation Activities Into Everyday Life Through Telerehabilitation: Qualitative Study of Cardiac Patients and Their Partners %A Dinesen,Birthe %A Nielsen,Gitte %A Andreasen,Jan Jesper %A Spindler,Helle %+ Laboratory of Welfare Technologies - Telehealth and Telerehabilitation, Department of Health Science and Technology, Aalborg University, Frederik Bajers vej 7, Aalborg, 9220, Denmark, 45 20515944, bid@hst.aau.dk %K telerehabilitation %K heart diseases %K social media %K qualitative study %D 2019 %7 15.04.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Implementation of cardiac rehabilitation has not been optimal, with patient participation rates below 50%. Factors that contribute to cardiac patients’ lack of participation in rehabilitation programs are patient motivation, logistical difficulties in getting to the rehabilitation facilities, lack of psychosocial elements, and individualization of activities in the rehabilitation programs. Telerehabilitation has been proposed as a new way to address the challenge of engaging and motivating cardiac patients and their partners to participate in rehabilitation. Objective: The aim of this study was to explore the experiences of cardiac patients and their partners of participating in the Teledialog Telerehabilitation Program (TTP). The Teledialog program consisted of a digital rehabilitation plan, transmission of health data from patient’s home to hospital and health care center, and an interactive Web portal with information and training videos. Methods: This case study used a theoretical approach combining the “community of practice” approach and self-determination theory. A triangulation of data collection techniques was used, including documents, participant observation (72 hours), and qualitative interviews with cardiac patients and their partners enrolled in the telerehabilitation group. A total of 14 cardiac patients, 12 patient spouses/partners, and 1 son participated in the study. The participants were interviewed at enrollment in the telerehabilitation program and after 12 weeks of participation in the program. Interview data were analyzed using NVivo 11.0. Results: Patients and their partners found the Web portal ActiveHeart.dk and the electronic rehabilitation (e-rehabilitation) plan to be helpful tools for health education, coordinating rehabilitation goals, creating an overview of the data, and ensuring continuity in the rehabilitation process. The patients felt that the TTP treated them as individuals, gave them a sense of autonomy, and provided enhanced relatedness to health care professionals and partners and a sense of competence as active participants in their own rehabilitation process. Some patients missed being part of a community of practice with other cardiac patients and did not use the Web forum. Patients’ partners found that the telerehabilitation program gave them a sense of security and helped them balance their involvement as a partner to the patient and not push the patient too hard. Conclusions: Cardiac patients and their partners found telerehabilitation technologies a useful digital toolbox in the rehabilitation process. Telerehabilitation motivated the patients to integrate rehabilitation activities into their work schedule and everyday life and made them feel like unique individuals. Participating in the Teledialog Telerehabilitation Program might not be a suitable strategy for all cardiac patients. Being a patient’s partner in the telerehabilitation program was associated with a heightened sense of security, navigation between active involvement in the rehabilitation process, being an equal partner, and not pushing the patient too hard. %M 30985284 %R 10.2196/13281 %U http://www.jmir.org/2019/4/e13281/ %U https://doi.org/10.2196/13281 %U http://www.ncbi.nlm.nih.gov/pubmed/30985284 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 4 %P e11446 %T Web-Based Parent Training Intervention With Telephone Coaching for Disruptive Behavior in 4-Year-Old Children in Real-World Practice: Implementation Study %A Ristkari,Terja %A Kurki,Marjo %A Suominen,Auli %A Gilbert,Sonja %A Sinokki,Atte %A Kinnunen,Malin %A Huttunen,Jukka %A McGrath,Patrick %A Sourander,Andre %+ Department of Child Psychiatry, Turku University Central Hospital, University of Turku, Lemminkäisenkatu 3, Teutori 3rd Floor, Turku, 20014, Finland, 358 504643141, terjaris@utu.fi %K child mental health %K early intervention %K parenting education %K disruptive behavior %K preschool children %D 2019 %7 11.04.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Parent training is the most effective approach to the psychosocial treatment of disruptive behavioral problems in childhood. However, no studies exist on how well Web-based training programs work when they make the transition from the research setting to implementation in primary health care. Objective: The study aimed to examine how the randomized controlled trial (RCT) and implementation study groups of the Strongest Families Smart Website (SFSW) intervention differed in child psychopathology, family demographics and treatment-related factors, such as therapeutic alliance and parents’ satisfaction rates. The intervention was conducted in the pediatric primary health care in Finland. Methods: The study focused on 232 parents who had taken part in the SFSW intervention, which formed part of a 2-arm RCT study, and 882 families that would participate in the subsequent SFSW implementation study group. Both groups comprised parents whose children displayed high levels of parent-reported disruptive behavioral problems when they were screened in child health clinics at 4 years of age. Parents in both groups were provided with the SFSW intervention, which consisted of a Web-based training program with 11 weekly themes and associated telephone sessions. Results: Demographic factors or duration of behavioral problems did not differ statistically or clinically between the RCT and implementation groups. Overall, 42.0% (362/862) of children in the implementation group and 35.4% (80/226) in the RCT intervention group had suffered from behavioral difficulties more than 1 year before the screening phase (χ12=3.2; P=.07). The mean duration of telephone coaching calls was very similar in the implementation and RCT intervention groups, that is, 38 and 37 min per call, respectively (t279.5=0.26; P=.79). The total time spent on the website of the program was 451 min in the implementation group and 431 min in the RCT intervention group (t318.8=1.38; P=.17). In the RCT intervention group, 52 of the 232 participants (22.4%) discontinued the program before the tenth week, whereas in the implementation group, 109 of the 882 participants (12.4%; odds ratio 2.05, 95% CI 1.4-3.0; P<.001) discontinued. Parents in both the implementation (77.1% to 98.5%, 498/742 to 731/742, respectively) and the RCT (64.8% to 98.2%, N=105/162- to 159/162, respectively) groups reported qualitatively similar and high level of posttreatment satisfaction rates in improved parenting skills, expectations, and stress relief. Parents in both groups reported a high level of satisfaction in skills and professionalism of the telephone coaches. Conclusions: The implementation of population-based screening of Web-based parent training intervention with telephone coaching resulted in good feasibility, fidelity, accessibility, and similar satisfaction level post treatment when compared with intervention in RCT research setting. The discontinuation of treatment in the implementation group was exceptionally low. %M 30973337 %R 10.2196/11446 %U https://www.jmir.org/2019/4/e11446/ %U https://doi.org/10.2196/11446 %U http://www.ncbi.nlm.nih.gov/pubmed/30973337 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 4 %P e12686 %T Effectiveness of Internet-Delivered Computerized Cognitive Behavioral Therapy for Patients With Insomnia Who Remain Symptomatic Following Pharmacotherapy: Randomized Controlled Exploratory Trial %A Sato,Daisuke %A Yoshinaga,Naoki %A Nagai,Eiichi %A Nagai,Kazue %A Shimizu,Eiji %+ Department of Cognitive Behavioral Physiology, Graduate School of Medicine, Chiba University, 1-8-1, Inohana, Chuo-ku, Chiba, 260-8670, Japan, 81 43 226 2027, daisuke-sato@umin.ac.jp %K insomnia %K cognitive behavioral therapy %K randomized controlled trial %K internet %K benzodiazepines %K residual symptoms %D 2019 %7 11.04.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: In reality, pharmacotherapy still remains the most common treatment for insomnia. Objective: This study aimed to examine the effectiveness of our internet-delivered computerized cognitive behavioral therapy (ICBT) program as an adjunct to usual care (UC) compared with UC alone in patients with insomnia who remain symptomatic following hypnotics. Methods: We recruited 23 patients with insomnia who remained symptomatic following pharmacologic treatment including benzodiazepines, and we conducted an exploratory randomized controlled trial. The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) at week 6 of the treatment. Secondary outcomes were sleep onset latency, total sleep time, sleep efficiency, number of awakenings, refreshment and soundness of sleep, anxiety by Hospital Anxiety and Depression Scale, depression measured by the Center for Epidemiologic Studies Depression Scale, and quality of life (QOL) measured by the EuroQol-5D. All parameters were measured at weeks 0 (baseline), 6 (postintervention), and 12 (follow-up). Results: The adjusted mean reduction (−6.11) in PSQI at week 6 from baseline in the ICBT plus UC group was significantly (P<.001) larger than the adjusted mean reduction (0.40) in the UC alone group. Significant differences were also found in favor of ICBT plus UC for PSQI, sleep onset latency, sleep efficiency, number of awakenings, and depression at all assessment points. Refreshment, soundness of sleep, anxiety, and QOL improved by week 6 in ICBT plus UC compared with UC alone. There were no reports of adverse events in either group during the study. Conclusions: These results indicated that our 6-week ICBT program is an effective treatment adjunct to UC for improving insomnia and related symptoms even after unsuccessful pharmacotherapy. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry: UMIN000021509; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023545 (Archived by WebCite at http://www.webcitation. org/75tCmwnYt). %M 30973344 %R 10.2196/12686 %U http://www.jmir.org/2019/4/e12686/ %U https://doi.org/10.2196/12686 %U http://www.ncbi.nlm.nih.gov/pubmed/30973344 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 4 %P e12541 %T Addressing Diabetes and Poorly Controlled Hypertension: Pragmatic mHealth Self-Management Intervention %A Lewinski,Allison A %A Patel,Uptal D %A Diamantidis,Clarissa J %A Oakes,Megan %A Baloch,Khaula %A Crowley,Matthew J %A Wilson,Jonathan %A Pendergast,Jane %A Biola,Holly %A Boulware,L Ebony %A Bosworth,Hayden B %+ Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Attn: HSR&D COIN (558/152), 508 Fulton St, Durham, NC,, United States, 1 919 286 0411 ext 7101, hayden.bosworth@duke.edu %K telemedicine %K cardiovascular diseases %K diabetes mellitus type 2 %K vulnerable populations %K renal insufficiency %K professional-patient relations %K hypertension %D 2019 %7 09.04.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Patients with diabetes and poorly controlled hypertension are at increased risk for adverse renal and cardiovascular outcomes. Identifying these patients early and addressing modifiable risk factors is central to delaying renal complications such as diabetic kidney disease. Mobile health (mHealth), a relatively inexpensive and easily scalable technology, can facilitate patient-centered care and promote engagement in self-management, particularly for patients of lower socioeconomic status. Thus, mHealth may be a cost-effective way to deliver self-management education and support. Objective: This feasibility study aimed to build a population management program by identifying patients with diabetes and poorly controlled hypertension who were at risk for adverse renal outcomes and evaluate a multifactorial intervention to address medication self-management. We recruited patients from a federally qualified health center (FQHC) in an underserved, diverse county in the southeastern United States. Methods: Patients were identified via electronic health record. Inclusion criteria were age between 18 and 75 years, diagnosis of type 2 diabetes, poorly controlled hypertension over the last 12 months (mean clinic systolic blood pressure [SBP] ≥140 mm Hg and/or diastolic blood pressure [DBP] ≥90 mm Hg), access to a mobile phone, and ability to receive text messages and emails. The intervention consisted of monthly telephone calls for 6 months by a case manager and weekly, one-way informational text messages. Engagement was defined as the number of phone calls completed during the intervention; individuals who completed 4 or more calls were considered engaged. The primary outcome was change in SBP at the conclusion of the intervention. Results: Of the 141 patients enrolled, 84.0% (118/141) of patients completed 1 or more phone calls and had follow-up SBP measurements for analysis. These patients were on average 56.9 years of age, predominately female (73/118, 61.9%), and nonwhite by self-report (103/118, 87.3%). The proportion of participants with poor baseline SBP control (50/118, 42.4%) did not change significantly at study completion (53/118, 44.9%) (P=.64). Participants who completed 4 or more phone calls (98/118, 83.1%) did not experience a statistically significant decrease in SBP when compared to those who completed fewer calls. Conclusion: We did not reduce uncontrolled hypertension even among the more highly engaged. However, 83% of a predominately minority and low-income population completed at least 67% of the multimodal mHealth intervention. Findings suggest that combining an automated electronic health record system to identify at-risk patients with a tailored mHealth protocol can provide education to this population. While this intervention was insufficient to effect behavioral change resulting in better hypertension control, it does suggest that this FQHC population will engage in low-cost population health applications with a potentially promising impact. Trial Registration: ClinicalTrials.gov NCT02418091; https://clinicaltrials.gov/ct2/show/NCT02418091 (Archived by WebCite at http://www.webcitation.org/76RBvacVU) %M 30964439 %R 10.2196/12541 %U https://www.jmir.org/2019/4/e12541/ %U https://doi.org/10.2196/12541 %U http://www.ncbi.nlm.nih.gov/pubmed/30964439 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 4 %P e11735 %T Implementation of a Novel Electronic Patient-Directed Smoking Cessation Platform for Cancer Patients: Interrupted Time Series Analysis %A Giuliani,Meredith Elana %A Liu,Geoffrey %A Xu,Wei %A Dirlea,Mihaela %A Selby,Peter %A Papadakos,Janet %A Abdelmutti,Nazek %A Yang,Dongyang %A Eng,Lawson %A Goldstein,David Paul %A Jones,Jennifer Michelle %+ Princess Margaret Cancer Centre, 610 University Ave, Toronto, ON, M5G 2C1, Canada, 1 4167864583, jonesbernard5@gmail.com %K neoplasms %K smoking cessation %K implementation science %K quality improvement %D 2019 %7 09.04.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Continued smoking in cancer patients undergoing treatment results in significantly higher rates of treatment toxicities and persistent effects, increased risk of recurrence and second malignancy, and increased all-cause mortality. Despite this, routine tobacco use screening and the provision of smoking cessation treatment has yet to be implemented widely in the cancer setting. Objective: The objective of this study was to implement and evaluate the adoption and impact of an innovative Smoking Cessation e-referral System (CEASE) to promote referrals to smoking cessation programs in cancer patients. Methods: A patient-directed electronic smoking cessation platform (CEASE) was developed to promote smoking screening and referral and implemented at 1 of Canada’s largest cancer centers. The implementation and evaluation were guided by the Ottawa Model of Research Use. An interrupted time series design was used to examine the impact of CEASE on screening rates, referrals offered, and referrals accepted compared with a previous paper-based screening program. A subsample of smokers or recent quitters was also assessed and compared pre- and postimplementation to examine the effect of CEASE on subsequent contact with smoking cessation programs and quit attempts. Results: A total of 17,842 new patients attended clinics over the 20-month study period. The CEASE platform was successfully implemented across all disease sites. Screening rates increased from 44.28% (2366/5343) using the paper-based approach to 65.72% (3538/5383) using CEASE (P<.01), and referrals offered to smokers who indicated interest in quitting increased from 18.6% (58/311) to 98.8% (421/426; P<.01). Accepted referrals decreased from 41% (24/58) to 20.4% (86/421), though the overall proportion of referrals generated from total current/recent tobacco users willing to quit increased from 5.8% (24/414) to 20.2% (86/426) due to the increase in referrals offered. At 1-month postscreening, there was no significant difference in the proportion that was currently using tobacco and had not changed use in the past 4 weeks (pre: 28.9% [24/83] and post: 28.8% [83/288]). However, contact with the referral program increased from 0% to 78% in the postCEASE cohort (P<.001). Conclusions: CEASE is an innovative tool to improve smoking screening and can be implemented in both a time- and cost-effective manner which promotes sustainability. CEASE was successfully implemented across all clinics and resulted in improvements in overall screening and referral rates and engagement with referral services. %M 30964445 %R 10.2196/11735 %U https://www.jmir.org/2019/4/e11735/ %U https://doi.org/10.2196/11735 %U http://www.ncbi.nlm.nih.gov/pubmed/30964445 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 4 %P e10859 %T Technology-Based Alcohol Interventions in Primary Care: Systematic Review %A Ramsey,Alex T %A Satterfield,Jason M %A Gerke,Donald R %A Proctor,Enola K %+ Department of Psychiatry, Washington University School of Medicine, 660 South Euclid, Campus Box 8134, St Louis, MO, 63110, United States, 1 3143625370, aramsey@wustl.edu %K alcohol drinking %K risky health behavior %K alcohol-related disorders %K internet %K computers %K mobile health %K primary health care %K implementation science %K review %D 2019 %7 08.04.2019 %9 Review %J J Med Internet Res %G English %X Background: Primary care settings are uniquely positioned to reach individuals at risk of alcohol use disorder through technology-delivered behavioral health interventions. Despite emerging effectiveness data, few efforts have been made to summarize the collective findings from these delivery approaches. Objective: The aim of this study was to review recent literature on the use of technology to deliver, enhance, or support the implementation of alcohol-related interventions in primary care. We focused on addressing questions related to (1) categorization or target of the intervention, (2) descriptive characteristics and context of delivery, (3) reported efficacy, and (4) factors influencing efficacy. Methods: We conducted a comprehensive search and systematic review of completed studies at the intersection of primary care, technology, and alcohol-related problems published from January 2000 to December 2018 within EBSCO databases, ProQuest Dissertations, and Cochrane Reviews. Of 2307 initial records, 42 were included and coded independently by 2 investigators. Results: Compared with the years of 2000 to 2009, published studies on technology-based alcohol interventions in primary care nearly tripled during the years of 2010 to 2018. Of the 42 included studies, 28 (64%) were randomized controlled trials. Furthermore, studies were rated on risk of bias and found to be predominantly low risk (n=18), followed by moderate risk (n=16), and high risk (n=8). Of the 24 studies with primary or secondary efficacy outcomes related to drinking and drinking-related harms, 17 (71%) reported reduced drinking or harm in all primary and secondary efficacy outcomes. Furthermore, of the 31 studies with direct comparisons with treatment as usual (TAU), 13 (42%) reported that at least half of the primary and secondary efficacy outcomes of the technology-based interventions were superior to TAU. High efficacy was associated with provider involvement and the reported use of an implementation strategy to deliver the technology-based intervention. Conclusions: Our systematic review has highlighted a pattern of growth in the number of studies evaluating technology-based alcohol interventions in primary care. Although these interventions appear to be largely beneficial in primary care, outcomes may be enhanced by provider involvement and implementation strategy use. This review enables better understanding of the typologies and efficacy of these interventions and informs recommendations for those developing and implementing technology-based alcohol interventions in primary care settings. %M 30958270 %R 10.2196/10859 %U https://www.jmir.org/2019/4/e10859/ %U https://doi.org/10.2196/10859 %U http://www.ncbi.nlm.nih.gov/pubmed/30958270 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 3 %N 2 %P e9910 %T A Pilot Randomized Controlled Trial of a Digital Intervention Aimed at Improving Food Purchasing Behavior: The Front-of-Pack Food Labels Impact on Consumer Choice Study %A Harrington,Richard A %A Scarborough,Peter %A Hodgkins,Charo %A Raats,Monique M %A Cowburn,Gill %A Dean,Moira %A Doherty,Aiden %A Foster,Charlie %A Juszczak,Edmund %A Ni Mhurchu,Cliona %A Winstone,Naomi %A Shepherd,Richard %A Timotijevic,Lada %A Rayner,Mike %+ Centre on Population Approaches for Non-Communicable Disease Prevention, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, United Kingdom, 44 1865289248, peter.scarborough@dph.ox.ac.uk %K diet %K randomized controlled trial %D 2019 %7 08.04.2019 %9 Original Paper %J JMIR Form Res %G English %X Background: Most food in the United Kingdom is purchased in supermarkets, and many of these purchases are routinely tracked through supermarket loyalty card data. Using such data may be an effective way to develop remote public health interventions and to measure objectively their effectiveness at changing food purchasing behavior. Objective: The Front-of-pack food Labels: Impact on Consumer Choice (FLICC) study is a pilot randomized controlled trial of a digital behavior change intervention. This pilot trial aimed to collect data on recruitment and retention rates and to provide estimates of effect sizes for the primary outcome (healthiness of ready meals and pizzas purchased) to inform a larger trial. Methods: The intervention consisted of a website where participants could access tailored feedback on previous purchases of ready meals and pizzas, set goals for behavior change, and model and practice the recommended healthy shopping behavior using traffic light labels. The control consisted of Web-based information on traffic light labeling. Participants were recruited via email from a list of loyalty card holders held by the participating supermarket. All food and drink purchases for the participants for the 6 months before recruitment, during the 6-week intervention period, and during a 12-week washout period were transferred to the research team by the participating supermarket. Healthiness of ready meals and pizzas was measured using a predeveloped scale based solely on the traffic light colors on the foods. Questionnaires were completed at recruitment, end of the intervention, and end of washout to estimate the effect of the intervention on variables that mediate behavior change (eg, belief and intention formation). Results: We recruited 496 participants from an initial email to 50,000 people. Only 3 people withdrew from the study, and purchase data were received for all other participants. A total of 208 participants completed all 3 questionnaires. There was no difference in the healthiness of purchased ready meals and pizzas between the intervention and control arms either during the intervention period (P=.32) or at washout (P=.59). Conclusions: Although the FLICC study did not find evidence of an impact of the intervention on food purchasing behavior, the unique methods used in this pilot trial are informative for future studies that plan to use supermarket loyalty card data in collaboration with supermarket partners. The experience of the trial showcases the possibilities and challenges associated with the use of loyalty card data in public health research. Trial Registration: ISRCTN Registry ISRCTN19316955; http://www.isrctn.com/ISRCTN19316955 (Archived by WebCite at http://www.webcitation.org/76IVZ9WjK) International Registered Report Identifier (IRRID): RR2-10.1186/s40814-015-0015-1 %M 30958277 %R 10.2196/formative.9910 %U http://formative.jmir.org/2019/2/e9910/ %U https://doi.org/10.2196/formative.9910 %U http://www.ncbi.nlm.nih.gov/pubmed/30958277 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 4 %P e12003 %T A Digital Game and School-Based Intervention for Students in Hong Kong: Quasi-Experimental Design %A Shum,Angie KY %A Lai,Eliza SY %A Leung,Wing Gi %A Cheng,Mabel NS %A Wong,Ho Kit %A So,Sam WK %A Law,Yik Wa %A Yip,Paul SF %+ The Hong Kong Jockey Club Centre for Suicide Research and Prevention, The University of Hong Kong, 2/F, The Hong Kong Jockey Club Building for Interdisciplinary Research, 5 Sassoon Road, Pokfulam, Hong Kong,, China (Hong Kong), 852 28315232, sfpyip@hku.hk %K digital game-based learning %K school-based learning %K mental health %K schools %K students %K child welfare %K health promotion %K follow-up studies %K internet access %K public health %K non-randomized controlled trials %D 2019 %7 05.04.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: In Hong Kong, with an increasing number of children experiencing mental health issues, there is a need to not only develop innovative interventions but also develop comprehensive prevention interventions so as to reduce their anxiety symptoms and enhance their emotional management and interpersonal relationships. Objective: The aim of this study was to determine the effectiveness of The Adventures of DoReMiFa, an integration model of the cognitive-behavioral approach and positive psychology by using digital game–based and school-based mental health enhancement intervention to magnify the social and emotional health and well-being of the school children in Hong Kong aged 9 to 11 years. Methods: A quasi-experimental design method was used to evaluate this digital game and school-based intervention. The Adventures of DoReMiFa was piloted in 4 primary schools where students were allocated to either an intervention or a control group. The participants were assessed at pre- and postintervention with a 6-month follow-up measuring their mental health knowledge, levels of anxiety symptoms, positive and negative thinking, perspective-taking, and self-esteem. Results: A total of 459 primary school students from 4 primary schools participated in the study. The response rate on the questionnaires answered on the Web was up to 85.1% (391/459). Compared with the control group, the intervention group was found to have significant association with improved mental health knowledge at the time immediately after the intervention (beta=.46; P=.01) and in the 6-month postintervention period (beta=.66; P<.001); for perspective-taking, the intervention group had exhibited a significant improvement 6 months after the completion of the universal program (beta=1.50; P=.03). The intervention, however, was found not to be effective in reducing the rates of anxiety symptoms and negative thinking among the participating students. Conclusions: The Adventures of DoReMiFa, an integration of a digital game–based and school-based mental health enhancement intervention, was shown to be effective in elevating the knowledge of mental health and promoting perspective-taking in the primary school students of Hong Kong. Although there was insufficient evidence to support a reduction in symptoms of anxiety and negative automatic thoughts, the overall results were still encouraging in that a preventive effect was found, indicating that the program has the potential to enhance the mental well-being of schoolchildren. It also suggests that knowledge enhancement may not necessarily lead to behavior change, and more focused effort may be needed to achieve the translation. The implications and limitations of this study and suggestions for future research were also discussed. %M 30950795 %R 10.2196/12003 %U https://www.jmir.org/2019/4/e12003/ %U https://doi.org/10.2196/12003 %U http://www.ncbi.nlm.nih.gov/pubmed/30950795 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 6 %N 4 %P e11521 %T Service Use History of Individuals Enrolling in a Web-Based Suicidal Ideation Treatment Trial: Analysis of Baseline Data %A Wong,Quincy JJ %A Werner-Seidler,Aliza %A Torok,Michelle %A van Spijker,Bregje %A Calear,Alison L %A Christensen,Helen %+ School of Social Sciences and Psychology, Western Sydney University, Kingswood Campus, Sydney,, Australia, 61 2 4736 0080, q.wong@westernsydney.edu.au %K internet %K treatment %K service use %K health service %K suicidal ideation %K suicide, attempted %K suicide %K facilities and services utilization %K telehealth %D 2019 %7 02.04.2019 %9 Original Paper %J JMIR Ment Health %G English %X Background: A significant recent innovation is the development of internet-based psychological treatments for suicidal thinking. However, we know very little about individuals experiencing suicidal ideation who seek help through Web-based services and, in particular, their previous health service use patterns. Objective: We aimed to examine service use history and its correlates among adults experiencing suicidal ideation who enrolled in a Web-based suicidal ideation treatment trial. Methods: We used baseline data of 418 individuals seeking Web-based treatment for their suicidal ideation recruited into a randomized controlled trial of a 6-week Web-based self-help program. Participants at preintervention reported demographic information, clinical characteristics, and health service use over the previous 6 months. Results: Participants had a high rate of service use in the 6 months before enrolling in the treatment trial (404/418, 96.7% of participants had contact with services). The two most common contact points were general practitioners (385/418, 92.1% of participants) and mental health professionals (295/418, 70.6% of participants). Notably, those with a previous single suicide attempt had lower odds of contact with any service than those with no attempt (odds ratio [OR] 0.21, 95% CI 0.05-0.86; P=.03). Those living in rural or remote areas had lower odds of contacting general practitioners (OR 0.35, 95% CI 0.13-0.91; P=.03) or mental health professionals (OR 0.44, 95% CI 0.23-0.83; P=.01) than those living in metropolitan areas. Conclusions: Individuals enrolling in an electronic health intervention trial have often received treatment from general practitioners or mental health professionals. These services can therefore play an important role in preventing the escalation of suicidal thinking. Enrollment in our Web-based treatment trial suggested, though, that face-to-face health services may not be enough. Our study also highlighted the need to improve the provision of coordinated and assertive care after a suicide attempt, as well as health service availability and utilization for those living in rural and remote areas. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12613000410752; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364016 (Archived by WebCite at http://www.webcitation.org/6vK5FvQXy); Universal Trial Number U1111-1141-6595 %M 30938686 %R 10.2196/11521 %U https://mental.jmir.org/2019/4/e11521/ %U https://doi.org/10.2196/11521 %U http://www.ncbi.nlm.nih.gov/pubmed/30938686 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 4 %P e13205 %T Patients’ Needs and Requirements for eHealth Pain Management Interventions: Qualitative Study %A Ledel Solem,Ingrid Konstanse %A Varsi,Cecilie %A Eide,Hilde %A Kristjansdottir,Olöf Birna %A Mirkovic,Jelena %A Børøsund,Elin %A Haaland-Øverby,Mette %A Heldal,Karina %A Schreurs,Karlein MG %A Waxenberg,Lori B %A Weiss,Karen Elizabeth %A Morrison,Eleshia J %A Solberg Nes,Lise %+ Center for Shared Decision Making and Collaborative Care Research, Division of Medicine, Oslo University Hospital, Oslo University Hospital HF, Division of Medicine, Aker hospital, Box 4950 Nydalen, Oslo, N-0424, Norway, 47 23 06 60 04, lise.solberg.nes@rr-research.no %K chronic pain %K eHealth %K self-management %K qualitative methods %K intervention development %K user-centered design %D 2019 %7 01.04.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: A growing body of evidence supports the potential effectiveness of electronic health (eHealth) interventions in managing chronic pain. However, research on the needs and preferences of patients with chronic pain in relation to eHealth interventions is scarce. Eliciting user input in the development of eHealth interventions may be a crucial step toward developing meaningful interventions for patients for potentially improving treatment outcomes. Objective: This study aimed to explore the experiences of patients with chronic pain with regard to information and communication technology, understand how an eHealth intervention can support the everyday needs and challenges of patients with chronic pain, and identify possible facilitators and barriers for patients’ use of an eHealth pain management intervention. Methods: Twenty patients living with chronic pain and five spouses participated in individual interviews. Semistructured interview guides were used to explore participants’ needs, experiences, and challenges in daily life as well as their information and communication technology experiences and preferences for eHealth support interventions. Spouses were recruited and interviewed to gain additional insight into the patients’ needs. The study used qualitative thematic analysis. Results: The participants were generally experienced technology users and reported using apps regularly. They were mainly in favor of using an eHealth self-management intervention for chronic pain and considered it a potentially acceptable way of gathering knowledge and support for pain management. The participants expressed the need for obtaining more information and knowledge, establishing a better balance in everyday life, and receiving support for improving communication and social participation. They provided suggestions for the eHealth intervention content and functionality to address these needs. Accessibility, personalization, and usability were emphasized as important elements for an eHealth support tool. The participants described an ideal eHealth intervention as one that could be used for support and distraction from pain, at any time or in any situation, regardless of varying pain intensity and concentration capacity. Conclusions: This study provides insight into user preferences for eHealth interventions aiming to address self-management for chronic pain. Participants highlighted important factors to be considered when designing and developing eHealth interventions for self-management of chronic pain, illustrating the importance and benefit of including users in the development of eHealth interventions. Trial Registration: ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104. %M 30877780 %R 10.2196/13205 %U https://www.jmir.org/2019/4/e13205/ %U https://doi.org/10.2196/13205 %U http://www.ncbi.nlm.nih.gov/pubmed/30877780 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 3 %P e9958 %T User-Centered Design of a Web-Based Tool to Support Management of Chemotherapy-Related Toxicities in Cancer Patients %A Prince,Rebecca M %A Soung Yee,Anthony %A Parente,Laura %A Enright,Katherine A %A Grunfeld,Eva %A Powis,Melanie %A Husain,Amna %A Gandhi,Sonal %A Krzyzanowska,Monika K %+ University Health Network, 610 University Ave., Toronto, ON,, Canada, 1 416 946 6542, monika.krzyzanowska@uhn.ca %K prototype %K Web-based tool %K toxicity management %K chemotherapy %K self-management %D 2019 %7 28.03.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Cancer patients receiving chemotherapy have high symptom needs that can negatively impact quality of life and result in high rates of unplanned acute care visits. Remote monitoring tools may improve symptom management in this patient population. Objective: This study aimed to design a prototype tool to facilitate remote management of chemotherapy-related toxicities. Methods: User needs were assessed using a participatory, user-centered design methodology that included field observation, interviews, and focus groups, and then analyzed using affinity diagramming. Participants included oncology patients, caregivers, and health care providers (HCPs) including medical oncologists, oncology nurses, primary care physicians, and pharmacists in Ontario, Canada. Overarching themes informed development of a Web-based prototype, which was further refined over 2 rounds of usability testing with end users. Results: Overarching themes were derived from needs assessments, which included 14 patients, 1 caregiver, and 12 HCPs. Themes common to both patients and HCPs included gaps and barriers in current systems, need for decision aids, improved communication and options in care delivery, secure access to credible and timely information, and integration into existing systems. In addition, patients identified missed opportunities, care not meeting their needs, feeling overwhelmed and anxious, and wanting to be more empowered. HCPs identified accountability for patient management as an issue. These themes informed development of a Web-based prototype (bridges), which included toxicity tracking, self-management advice, and HCP communication functionalities. Usability testing with 11 patients and 11 HCPs was generally positive; however, identified challenges included tool integration into existing workflows, need for standardized toxicity self-management advice, issues of privacy and consent, and patient-tailored information. Conclusions: Web-based tools integrating just-in-time self-management advice and HCP support into routine care may address gaps in systems for managing chemotherapy-related toxicities. Attention to the integration of new electronic tools into self-care by patients and practice was a strong theme for both patients and HCP participants and is a key issue that needs to be addressed for wide-scale adoption. %M 30920373 %R 10.2196/jmir.9958 %U http://www.jmir.org/2019/3/e9958/ %U https://doi.org/10.2196/jmir.9958 %U http://www.ncbi.nlm.nih.gov/pubmed/30920373 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 3 %P e11014 %T Social Media Intervention Design: Applying an Affordances Framework %A Moreno,Megan A %A D'Angelo,Jonathan %+ Department of Pediatrics, School of Medicine and Public Health, University of Wisconsin, 2870 University Ave, Suite 200, Madison, WI, 53705, United States, 1 6082632846, mamoreno@pediatrics.wisc.edu %K social media %K health %K adolescent %K research %D 2019 %7 26.03.2019 %9 Viewpoint %J J Med Internet Res %G English %X Social media interventions are a growing area of internet research, particularly for adolescent health. Researchers developing social media intervention approaches face the task of selecting a social media platform for their intervention. In this paper, we present the theoretical framework of affordances to help guide social media platform selection for intervention research. Affordances are a concept often used in fields associated with design and by those systematically studying the impact of a design of an object. Thus, the affordances approach is often used by those considering the impact of information technology and the design of social media platforms. Affordances are often described as properties of artifacts that can be recognized by users and contribute to their function or items that present an action possibility. We describe common affordances that can be applied to intervention design as well as current evidence and an intervention case example for each affordance. A scientific approach for the selection of the appropriate social media platform for a given intervention is an important research priority to advance the field of internet research. %M 30912754 %R 10.2196/11014 %U http://www.jmir.org/2019/3/e11014/ %U https://doi.org/10.2196/11014 %U http://www.ncbi.nlm.nih.gov/pubmed/30912754 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 2 %N 1 %P e12501 %T Feasibility and Acceptability of a Culturally Tailored Website to Increase Fruit and Vegetable Intake and Physical Activity Levels in African American Mother-Child Dyads: Observational Study %A Chung,Alicia %A Wallace,Barbara %A Stanton-Koko,Monica %A Seixas,Azizi %A Jean-Louis,Girardin %+ New York University School of Medicine, 180 Madison Avenue, New York, NY, 10016, United States, 1 646 501 2608, alicia.chung@nyumc.org %K childhood obesity %K eHealth %K social justice %D 2019 %7 22.03.2019 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: African American youth (aged 8-14 years) do not adhere to national dietary and physical activity guidelines. Nonadherence to these recommendations contributes to disproportionate rates of obesity compared with their white counterparts. Culturally tailored electronic health (eHealth) solutions are needed to communicate nutrition and physical activity messages that resonate with this target population. Objective: This study aimed to identify the impact of exposure to a website hosting culturally tailored cartoons to inspire fruit and vegetable uptake and physical activity levels in African American mother-child dyads. Methods: Statistical analysis included paired sample t tests to evaluate knowledge gains, self-efficacy, and readiness to change. Adapted items from Prochaska’s Stages of Change toward the following 4 behaviors were assessed with pre- and posttest surveys: (1) fruit and vegetable selection on my plate, (2) meal preparation, (3) fruit and vegetable selection outside of home, and (4) physical activity. Open-ended comments on videos from mother-child dyads were used to determine user acceptance. Observations of repeated responses during content analysis informed coding and development of key themes. Results: A final sample size of 93 mother-child dyads completed the study. Mothers reported significant improvement from precontemplation or contemplation stages to preparation or action stages for (1) fruit and vegetable selection on her plate (P=.03), (2) meal preparation for her family (P=.01), (3) fruit and vegetable selection outside the home (P<.001), and (4) physical activity (P<.001). Significant improvements were found in knowledge, stage of change, and self-efficacy for the 4 target behaviors of interest (P<.001). Children’s open-ended commentary reported vicarious learning and positive character identification with brown-skinned cartoons exhibiting healthful food and exercise behaviors. Mothers commented on the lack of accessible produce in their neighborhoods not depicted in the cartoon videos. Conclusions: Culturally adapted cartoons that incorporate tailored preferences by African American families, such as race or demography, may help increase adherence to target health behaviors when developing eHealth behavior solutions. %M 31518320 %R 10.2196/12501 %U http://pediatrics.jmir.org/2019/1/e12501/ %U https://doi.org/10.2196/12501 %U http://www.ncbi.nlm.nih.gov/pubmed/31518320 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 3 %P e10855 %T Training Cognitive Functions Using Mobile Apps in Breast Cancer Patients: Systematic Review %A Vergani,Laura %A Marton,Giulia %A Pizzoli,Silvia Francesca Maria %A Monzani,Dario %A Mazzocco,Ketti %A Pravettoni,Gabriella %+ Department of Oncology and Hemato-Oncology, University of Milan, Via Festa del Perdono 7, Milan, 20122, Italy, 39 029 4372099, laura.vergani@ieo.it %K cognitive impairment %K breast cancer %K cognitive training %K intervention %K mobile-based interventions %D 2019 %7 19.03.2019 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Breast cancer is an invalidating disease and its treatment can bring serious side effects that have a physical and psychological impact. Specifically, cancer treatment generally has a strong impact on cognitive function. In recent years, new technologies and eHealth have had a growing influence on health care and innovative mobile apps can be useful tools to deliver cognitive exercise in the patient’s home. Objective: This systematic review gives an overview of the state-of-the-art mobile apps aimed at training cognitive functions to better understand whether these apps could be useful tools to counteract cognitive impairment in breast cancer patients. Methods: We searched in a systematic way all the full-text articles from the PubMed and Embase databases. Results: We found eleven studies using mobile apps to deliver cognitive training. They included a total of 819 participants. App and study characteristics are presented and discussed, including cognitive domains trained (attention, problem solving, memory, cognitive control, executive function, visuospatial function, and language). None of the apps were specifically developed for breast cancer patients. They were generally developed for a specific clinical population. Only 2 apps deal with more than 1 cognitive domain, and only 3 studies focus on the efficacy of the app training intervention. Conclusions: These results highlight the lack of empirical evidence on the efficacy of currently available apps to train cognitive function. Cognitive domains are not well defined across studies. It is noteworthy that no apps are specifically developed for cancer patients, and their applicability to breast cancer should not be taken for granted. Future studies should test the feasibility, usability, and effectiveness of available cognitive training apps in women with breast cancer. Due to the complexity and multidimensionality of cognitive difficulties in this cancer population, it may be useful to design, develop, and implement an ad hoc app targeting cognitive impairment in breast cancer patients. %M 30888326 %R 10.2196/10855 %U https://mhealth.jmir.org/2019/3/e10855/ %U https://doi.org/10.2196/10855 %U http://www.ncbi.nlm.nih.gov/pubmed/30888326 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 3 %P e11276 %T Internet-Based Cognitive Behavioral Therapy in Stepped Care for Chronic Fatigue Syndrome: Randomized Noninferiority Trial %A Worm-Smeitink,Margreet %A Janse,Anthonie %A van Dam,Arno %A Evers,Andrea %A van der Vaart,Rosalie %A Wensing,Michel %A Knoop,Hans %+ Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, PO Box 22660, Amsterdam, 1100DD, Netherlands, 31 205668506, hans.knoop@amc.uva.nl %K eHealth %K chronic fatigue syndrome %K cognitive behavioral therapy %K randomized controlled trial %D 2019 %7 14.03.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-based cognitive behavioral therapy (I-CBT) leads to a reduction of fatigue severity and disability in adults with chronic fatigue syndrome (CFS). However, not all patients profit and it remains unclear how I-CBT is best embedded in the care of CFS patients. Objective: This study aimed to compare the efficacy of stepped care, using therapist-assisted I-CBT, followed by face-to-face (f2f) cognitive behavioral therapy (CBT) when needed, with f2f CBT (treatment as usual [TAU]) on fatigue severity. The secondary aim was to investigate treatment efficiency. Methods: A total of 363 CFS patients were randomized to 1 of the 3 treatment arms (n=121). There were 2 stepped care conditions that differed in the therapists’ feedback during I-CBT: prescheduled or on-demand. When still severely fatigued or disabled after I-CBT, the patients were offered f2f CBT. Noninferiority of both stepped care conditions to TAU was tested using analysis of covariance. The primary outcome was fatigue severity (Checklist Individual Strength). Disabilities (Sickness Impact Profile -8), physical functioning (Medical Outcomes Survey Short Form-36), psychological distress (Symptom Checklist-90), and proportion of patients with clinically significant improvement in fatigue were the secondary outcomes. The amount of invested therapist time was compared between stepped care and TAU. Exploratory comparisons were made between the stepped care conditions of invested therapist time and proportion of patients who continued with f2f CBT. Results: Noninferiority was indicated, as the upper boundary of the one-sided 98.75% CI of the difference in the change in fatigue severity between both forms of stepped care and TAU were below the noninferiority margin of 5.2 (4.25 and 3.81, respectively). The between-group differences on the secondary outcomes were also not significant (P=.11 to P=.79). Both stepped care formats required less therapist time than TAU (median 8 hours, 9 minutes and 7 hours, 25 minutes in stepped care vs 12 hours in TAU; P<.001). The difference in therapist time between both stepped care formats was not significant. Approximately half of the patients meeting step-up criteria for f2f CBT after I-CBT did not continue. Conclusions: Stepped care, including I-CBT followed by f2f CBT when indicated, is noninferior to TAU of f2f CBT and requires less therapist time. I-CBT for CFS can be used as a first step in stepped care. Trial Registration: Nederlands Trial Register NTR4809; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4809 (Archived by WebCite at http://www.webcitation.org/74SWkw1V5) %M 30869642 %R 10.2196/11276 %U http://www.jmir.org/2019/3/e11276/ %U https://doi.org/10.2196/11276 %U http://www.ncbi.nlm.nih.gov/pubmed/30869642 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 3 %P e12441 %T Partnering With Mommy Bloggers to Disseminate Breast Cancer Risk Information: Social Media Intervention %A Wright,Kevin %A Fisher,Carla %A Rising,Camella %A Burke-Garcia,Amelia %A Afanaseva,Dasha %A Cai,Xiaomei %+ George Mason University, Northeast Module, Room 102, Fairfax, VA,, United States, 1 413 362 5611, kwrigh16@gmu.edu %K breast cancer %K environment and public health %K risk reduction behavior %K blogging %K social networking %K social media %K health communication %K information dissemination %D 2019 %7 07.03.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Women are concerned about reducing their breast cancer risk, particularly if they have daughters. Social media platforms, such as blogs written by mothers, are increasingly being recognized as a channel that women use to make personal and family health–related decisions. Government initiatives (eg, Interagency Breast Cancer and Environmental Research Coordinating Committee) and researchers have called for scientists and the community to partner and disseminate scientifically and community-informed environmental risk information. Objective: We developed and evaluated a blog intervention to disseminate breast cancer and environmental risk information to mothers. We teamed with mommy bloggers to disseminate a message that we developed and tailored for mothers and daughters based on scientific evidence from the Breast Cancer and the Environment Research Program (BCERP). We posited that the intervention would influence women’s exposure to, acceptance of, and beliefs about environmental risks while promoting their intention to adopt risk-reducing behaviors. Methods: Using a quasi-experimental design, we recruited 75 mommy bloggers to disseminate the breast cancer risk message on their respective blogs and examined the impact of the intervention on (1) readers exposed to the intervention (n=445) and (2) readers not exposed to the intervention (comparison group; n=353). Results: Following the intervention, blog reader scores indicating exposure to the breast cancer risk and prevention information were greater than scores of blog readers who were not exposed (or did not recall seeing the message; mean 3.92, SD 0.85 and mean 3.45, SD 0.92, respectively; P<.001). Readers who recalled the intervention messages also had higher breast cancer risk and prevention information satisfaction scores compared with readers who did not see (or recall) the messages (mean 3.97, SD 0.75 and mean 3.57, SD 0.94, respectively; P<.001). Blog readers who recalled seeing the intervention messages were significantly more likely to share the breast cancer risk and prevention information they read, with their daughters specifically, than readers who did not recall seeing them (χ21=8.1; P=.004). Those who recalled seeing the intervention messages reported significantly higher breast cancer risk and prevention information influence scores, indicative of behavioral intentions, than participants who did not recall seeing them (mean 11.22, SD 2.93 and mean 10.14, SD 3.24, respectively; P=.003). Most women ranked Facebook as their first choice for receiving breast cancer risk information. Conclusions: Results indicated that blog readers who were exposed to (and specifically recalled) the BCERP-adapted intervention messages from mommy bloggers had higher breast cancer risk and prevention information exposure scores and higher breast cancer risk and prevention information satisfaction and influence scores than those who did not see (or recall) them. Mommy bloggers may be important opinion leaders for some women and key to enhancing the messaging, delivery, and impact of environmental breast cancer risk information on mothers. %M 30843866 %R 10.2196/12441 %U https://www.jmir.org/2019/3/e12441/ %U https://doi.org/10.2196/12441 %U http://www.ncbi.nlm.nih.gov/pubmed/30843866 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 2 %P e11874 %T A Web-Based Intervention (MotivATE) to Increase Attendance at an Eating Disorder Service Assessment Appointment: Zelen Randomized Controlled Trial %A Denison-Day,James %A Muir,Sarah %A Newell,Ciarán %A Appleton,Katherine M %+ Research Centre for Behaviour Change, Psychology Department, Bournemouth University, P104, Poole House, Talbot Campus, Poole, BH12 5BB, United Kingdom, 44 7590989774, jday2@bournemouth.ac.uk %K feeding disorders %K eating disorders %K anorexia nervosa %K bulimia nervosa %K binge-eating disorder %K motivation %K early medical intervention %K Internet %D 2019 %7 27.02.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Early assessment and treatment of eating disorder patients is important for patient outcomes. However, up to a third of people referred for treatment do not access services and 16.4% do not attend their first scheduled assessment appointment. MotivATE is a fully automated, novel, Web-based program intended to increase motivation to change eating disorder behaviors, designed for delivery at the point of invitation to an eating disorder service, with the aim of increasing service attendance. Objective: This paper assesses the impact of MotivATE on attendance at assessment when compared with treatment-as-usual. Methods: A Zelen randomized controlled design was used. All individuals referred to a specialist eating disorder service, Kimmeridge Court in Dorset, UK, over the course of a year (October 24, 2016-October 23, 2017) were randomized to treatment-as-usual only or treatment-as-usual plus an additional letter offering access to MotivATE. Attendance at the initial scheduled assessment appointment was documented. Logistic regression analysis assessed the impact of MotivATE on attendance at assessment. Additional analyses based on levels of engagement with MotivATE were also undertaken. Results: A total of 313 participants took part: 156 (49.8%) were randomized to treatment-as-usual and 157 (50.2%) were randomized to receive the additional offer to access MotivATE. Intention-to-treat analysis between conditions showed no impact of MotivATE on attendance at assessment (odds ratio [OR] 1.35, 95% CI 0.69-2.66, P=.38). Examination of the usage data indicated that only 53 of 157 participants (33.8%) in the MotivATE condition registered with the Web-based intervention. An analysis comparing those that registered with the intervention with those that did not found greater attendance at assessment in those that had registered (OR 9.46, 95% CI 1.22-73.38, P=.03). Conclusions: Our primary analyses suggest no impact of MotivATE on attendance at the first scheduled assessment appointment, but secondary analyses revealed limited engagement with the program and improved attendance in those who did engage. It is unclear, however, if engagement with the program increased motivation and, in turn, attendance or if more motivated individuals were more likely to access the intervention. Further research is required to facilitate engagement with Web-based interventions and to understand the full value of MotivATE for users. Trial Registration: ClinicalTrials.gov NCT02777944; https://clinicaltrials.gov/ct2/show/NCT02777944 (Archived by WebCite at http://www.webcitation.org/75VDEFZZ4) %M 30810533 %R 10.2196/11874 %U http://www.jmir.org/2019/2/e11874/ %U https://doi.org/10.2196/11874 %U http://www.ncbi.nlm.nih.gov/pubmed/30810533 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 2 %P e12854 %T A Smoking Prevention Program Delivered by Medical Students to Secondary Schools in Brazil Called “Education Against Tobacco”: Randomized Controlled Trial %A Lisboa,Oscar Campos %A Bernardes-Souza,Breno %A Xavier,Luiz Eduardo De Freitas %A Almeida,Matheus Rocha %A Corrêa,Paulo César Rodrigues Pinto %A Brinker,Titus Josef %+ National Center for Tumor Diseases, German Cancer Research Center, University of Heidelberg, Im Neuenheimer Feld 460, Heidelberg, 69120, Germany, 49 62213219304, titus.brinker@nct-heidelberg.de %K smoking %K tobacco %K prevention %K medical students %K schools %D 2019 %7 21.02.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Smoking is the largest preventable cause of mortality in Brazil. Education Against Tobacco (EAT) is a network of more than 3500 medical students and physicians across 14 countries who volunteer for school-based smoking prevention programs. EAT educates 50,000 adolescents per year in the classroom setting. A recent quasi-experimental study conducted in Germany showed that EAT had significant short-term smoking cessation effects among adolescents aged 11 to 15 years. Objective: The aim is to measure the long-term effectiveness of the most recent version of the EAT curriculum in Brazil. Methods: A randomized controlled trial was conducted among 2348 adolescents aged 12 to 21 years (grades 7-11) at public secondary schools in Brazil. The prospective experimental design included measurements at baseline and at 6 and 12 months postintervention. The study groups comprised randomized classes receiving the standardized EAT intervention (90 minutes of mentoring in a classroom setting) and control classes in the same schools (no intervention). Data were collected on smoking status, gender, social aspects, and predictors of smoking. The primary endpoint was the difference in the change in smoking prevalence between the intervention group and the control group at 12-month follow-up. Results: From baseline to 12 months, the smoking prevalence increased from 11.0% to 20.9% in the control group and from 14.1% to 15.6% in the intervention group. This difference was statistically significant (P<.01). The effects were smaller for females (control 12.4% to 18.8% vs intervention 13.1% to 14.6%) than for males (control 9.1% to 23.6% vs intervention 15.3% to 16.8%). Increased quitting rates and prevented onset were responsible for the intervention effects. The differences in change in smoking prevalence from baseline to 12 months between the intervention and control groups were increased in students with low school performance. Conclusions: To our knowledge, this is the first randomized trial on school-based tobacco prevention in Brazil that shows significant long-term favorable effects. The EAT program encourages quitting and prevents smoking onset, especially among males and students with low educational background. Trial Registration: ClinicalTrials.gov NCT02725021; https://clinicaltrials.gov/ct2/show/NCT02725021 International Registered Report Identifier (IRRID): RR2-10.2196/resprot.7134 %M 30789347 %R 10.2196/12854 %U http://www.jmir.org/2019/2/e12854/ %U https://doi.org/10.2196/12854 %U http://www.ncbi.nlm.nih.gov/pubmed/30789347 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 2 %P e12894 %T Resilience@Work Mindfulness Program: Results From a Cluster Randomized Controlled Trial With First Responders %A Joyce,Sadhbh %A Shand,Fiona %A Lal,Tara J %A Mott,Brendan %A Bryant,Richard A %A Harvey,Samuel B %+ School of Psychiatry, Faculty of Medicine, University of New South Wales, The Black Dog Institute, Hospital Road, Randwick, 2031, Australia, 61 401297711, sadhbh.joyce@unsw.edu.au %K resilience training %K workplace mental health %K occupational health %K well-being %K online intervention %K employee resilience %K health and safety %K psychological health %K first responders %D 2019 %7 19.02.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: A growing body of research suggests that resilience training can play a pivotal role in creating mentally healthy workplaces, particularly with regard to protecting the long-term well-being of workers. Emerging research describes positive outcomes from various types of resilience training programs (RTPs) among different occupational groups. One specific group of workers that may benefit from this form of proactive resilience training is first responders. Given the nature of their work, first responders are frequently exposed to stressful circumstances and potentially traumatic events, which may impact their overall resilience and well-being over time. Objective: This study aimed to examine whether a mindfulness-based RTP (the Resilience@Work [RAW] Mindfulness Program) delivered via the internet can effectively enhance resilience among a group of high-risk workers. Methods: We conducted a cluster randomized controlled trial (RCT) comprising 24 Primary Fire and Rescue and Hazmat stations within New South Wales. Overall, 12 stations were assigned to the 6-session RAW Mindfulness Program and 12 stations were assigned to the control condition. A total of 143 active full-time firefighters enrolled in the study. Questionnaires were administered at baseline, immediately post training, and at 6-month follow-up. Measurements examined change in both adaptive and bounce-back resilience as well as several secondary outcomes examining resilience resources and acceptance and mindfulness skills. Results: Mixed-model repeated measures analysis found that the overall test of group-by-time interaction was significant (P=.008), with the intervention group increasing in adaptive resilience over time. However, no significant differences were found between the intervention group and the control group in terms of change in bounce-back resilience (P=.09). At 6-month follow-up, the group receiving the RAW intervention had an average increase in their resilience score of 1.3, equating to a moderate-to-large effect size compared with the control group of 0.73 (95% CI 0.38-1.06). Per-protocol analysis found that compared with the control group, the greatest improvements in adaptive resilience were observed among those who completed most of the RAW program, that is, 5 to 6 sessions (P=.002). Conclusions: The results of this RCT suggest that mindfulness-based resilience training delivered in an internet format can create improvements in adaptive resilience and related resources among high-risk workers, such as first responders. Despite a number of limitations, the results of this study suggest that the RAW Mindfulness Program is an effective, scalable, and practical means of delivering online resilience training in high-risk workplace settings. To the best of our knowledge, this is the first time a mindfulness-based RTP delivered entirely via the internet has been tested in the workplace. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12615000574549; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368296 (Archived by WebCite at http://www.webcitation.org/75w4xtrpw). %M 30777846 %R 10.2196/12894 %U http://www.jmir.org/2019/2/e12894/ %U https://doi.org/10.2196/12894 %U http://www.ncbi.nlm.nih.gov/pubmed/30777846 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 2 %P e11065 %T Evaluation of Mothers’ Perceptions of a Technology-Based Supportive Educational Parenting Program (Part 2): Qualitative Study %A Shorey,Shefaly %A Ng,Esperanza Debby %+ National University of Singapore, Level 2 Clinical Research Centre, 10 Medical Drive, Singapore, 117597, Singapore, 65 66011294, nurssh@nus.edu.sg %K education %K mothers %K parenting %K technology %D 2019 %7 13.02.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Transitioning into parenthood can be stressful as parents struggle to cope with new parenting responsibilities. Although perinatal care in hospitals aims to improve parental outcomes, there is a general consensus that it is suboptimal and insufficient. Therefore, many studies have designed intervention methods to supplement support for parents during this stressful period. However, studies often focus on parental outcomes as indicators of their interventions’ success and effectiveness. Studies evaluating participants’ experiences and feedback are limited. Objective: This study aimed to examine the experiences and perceptions of participants who participated in a supportive education parenting program intervention study. Methods: A qualitative semistructured interview was conducted with 16 mothers (6 control and 10 intervention) from a randomized controlled trial. The supportive education parenting program received by the intervention group included 2 phone-based perinatal educational sessions, a phone-based educational session after childbirth, and a 1-month postpartum access to a mobile health app. The interviews were approximately 30- to 60-min long, audiotaped and transcribed verbatim, and analyzed using thematic analysis. Study findings were reported according to the Consolidated Criteria for Reporting Qualitative Research checklist. Results: The 3 main themes evaluating mothers’ experiences and perceptions were generated: (1) changed perspective toward parenthood, (2) journey from pregnancy to after birth, and (3) a way forward. Mothers from the intervention group mostly had good perinatal experiences with sufficient support received, which elevated their emotional well-being and increased parenting involvement. Mothers in the control group, although satisfied with the hospital care received, were more stressed and shared a need for professional advice and extra support. Apart from technical enhancements, mothers also requested extended social support during early pregnancy up to 1 year postpartum, taking into consideration Asian cultural practices. Conclusions: Mothers who received the intervention were overall satisfied with the support provided by the technology-based supportive educational parenting program. The success of the educational program in this study highlights the need to supplement standard care in hospitals with technology-based educational programs. Future research should include fathers’ perceptions to attain an in-depth understanding of overall participants’ experiences and needs in the future development of supportive and educational programs. %M 30758295 %R 10.2196/11065 %U https://www.jmir.org/2019/2/e11065/ %U https://doi.org/10.2196/11065 %U http://www.ncbi.nlm.nih.gov/pubmed/30758295 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 2 %P e10816 %T Effectiveness of a Technology-Based Supportive Educational Parenting Program on Parental Outcomes (Part 1): Randomized Controlled Trial %A Shorey,Shefaly %A Ng,Yvonne Peng Mei %A Ng,Esperanza Debby %A Siew,An Ling %A Mörelius,Evalotte %A Yoong,Joanne %A Gandhi,Mihir %+ Clinical Research Centre, Alice Lee Centre for Nursing Studies, National University of Singapore, 10 Medical Drive, Singapore, 117597, Singapore, 65 66011294, nurssh@nus.edu.sg %K parents %K social support %D 2019 %7 13.02.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Transitioning into parenthood can be stressful for new parents, especially with the lack of continuity of care from health care professionals during the postpartum period. Short hospital stays limit the availability of support and time parents need to be well equipped with parenting and infant care skills. Poor parental adjustment may, in turn, lead to negative parental outcomes and adversely affect the child’s development. For the family’s future well-being, and to facilitate a smoother transition into parenthood, there is a need for easily accessible, technology-based educational programs to support parents during the crucial perinatal period. Objective: This study aimed to examine the effectiveness of a technology-based supportive educational parenting program (SEPP) on parenting outcomes during the perinatal period in couples. Methods: A randomized, single-blinded, parallel-armed, controlled trial was conducted. The study recruited 236 parents (118 couples) from an antenatal clinic of a tertiary hospital in Singapore. Eligible parents were randomly assigned to the intervention group (n=118) or the control group (n=118). The SEPP is based on Bandura’s self-efficacy theory and Bowlby’s theory of attachment. Components of the intervention include 2 telephone-based educational sessions (1 antenatal and 1 immediately postnatal) and a mobile health app follow-up for 1 month. The control group only received routine perinatal care provided by the hospital. Outcome measures including parenting self-efficacy (PSE), parental bonding, perceived social support, parenting satisfaction, postnatal depression (PND), and anxiety were measured using reliable and valid instruments. Data were collected over 6 months at 4 time points: during pregnancy (third trimester), 2 days postpartum, 1 month postpartum, and 3 months postpartum. Outcomes were standardized using baseline means and SDs. Linear mixed models were used to compare the groups for postpartum changes in the outcome variables. Results: The intervention group showed significantly better outcome scores than the control group from baseline to 3 months postpartum for PSE (mean difference, MD, 0.37; 95% CI 0.06 to 0.68; P=.02), parental bonding (MD −1.32; 95% CI −1.89 to −0.75; P<.001), self-perceived social support (MD 0.69; 95% CI 0.18 to 1.19; P=.01), parenting satisfaction (MD 1.40; 95% CI 0.86 to 1.93; P<.001), and PND (MD −0.91; 95% CI −1.34 to −0.49; P<.001). Postnatal anxiety (PNA) scores of the intervention group were only significantly better after adjusting for covariates (MD −0.82; 95% CI −1.15 to −0.49; P<.001). Conclusions: The technology-based SEPP is effective in enhancing parental bonding, PSE, perceived social support and parental satisfaction, and in reducing PND and PNA. Health care professionals could incorporate it with existing hands-on infant care classes and routine care to better meet parents’ needs and create positive childbirth experiences, which may in turn encourage parents to have more children. Trial Registration: ISRCTN Registry ISRCTN48536064; http://www.isrctn.com/ISRCTN48536064 (Archived by WebCite at http://www.webcitation.org/6wMuEysiO). %M 30758289 %R 10.2196/10816 %U http://www.jmir.org/2019/2/e10816/ %U https://doi.org/10.2196/10816 %U http://www.ncbi.nlm.nih.gov/pubmed/30758289 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 2 %P e11964 %T An Internet-Based Childhood Obesity Prevention Program (Time2bHealthy) for Parents of Preschool-Aged Children: Randomized Controlled Trial %A Hammersley,Megan L %A Okely,Anthony D %A Batterham,Marijka J %A Jones,Rachel A %+ Early Start, Faculty of Social Sciences, University of Wollongong, Northfields Avenue, Wollongong, 2522, Australia, 61 242215670, megan.hammersley1@uowmail.edu.au %K internet %K eHealth %K food intake %K physical activity %K screen time %K sleep %K self efficacy %K body mass index %D 2019 %7 08.02.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Electronic health (eHealth) obesity programs offer benefits to traditionally delivered programs and have shown promise in improving obesity-related behaviors in children. Objective: This study aimed to assess the efficacy of a parent-focused, internet-based healthy lifestyle program for preschool-aged children, who are overweight or at or above the fiftieth percentile for body mass index (BMI) for their age and sex, on child BMI, obesity-related behaviors, parent modeling, and parent self-efficacy. Methods: The Time2bHealthy randomized controlled trial was conducted in Australia, during 2016 to 2017. Participants were recruited both online and through more traditional means within the community. Parent or carer, and child (aged 2-5 years) dyads were randomized into an intervention or comparison group. Intervention participants received an 11-week internet-based healthy lifestyle program, underpinned by social cognitive theory, followed by fortnightly emails for 3 months thereafter. Intervention participants set goals and received individual feedback from a dietitian. They were also encouraged to access and contribute to a closed Facebook group to communicate with other participants and the dietitian. Comparison participants received email communication only. Objectively measured child BMI was the primary outcome. Secondary outcomes included objectively measured physical activity, parent-measured and objectively measured sleep habits, and parent-reported dietary intake, screen time, child feeding, parent modeling, and parent self-efficacy. All data were collected at face-to-face appointments at baseline, 3 months, and 6 months by blinded data collectors. Randomization was conducted using a computerized random number generator post baseline data collection. Results: A total of 86 dyads were recruited, with 42 randomized to the intervention group and 44 to the comparison group. Moreover, 78 dyads attended the 3- and 6-month follow-ups, with 7 lost to follow-up and 1 withdrawing. Mean child age was 3.46 years and 91% (78/86) were in the healthy weight range. Overall, 69% (29/42) of participants completed at least 5 of the 6 modules. Intention-to-treat analyses found no significant outcomes for change in BMI between groups. Compared with children in the comparison group, those in the intervention group showed a reduced frequency of discretionary food intake (estimate −1.36, 95% CI −2.27 to −0.45; P=.004), and parents showed improvement in child feeding pressure to eat practices (−0.30, 95% CI 0.06 to −0.00; P=.048) and nutrition self-efficacy (0.43, 95% CI 0.10 to 0.76; P=.01). No significant time by group interaction was found for other outcomes. Conclusions: The trial demonstrated that a parent-focused eHealth childhood obesity prevention program can provide support to improve dietary-related practices and self-efficacy but was not successful in reducing BMI. The target sample size was not achieved, which would have affected statistical power. Trial Registration: Australian New Zealand Clinical Trials Registry ANZCTR12616000119493; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=370030 (Archived by WebCite at http://www.webcitation.org/74Se4S7ZZ). %M 30735139 %R 10.2196/11964 %U http://www.jmir.org/2019/2/e11964/ %U https://doi.org/10.2196/11964 %U http://www.ncbi.nlm.nih.gov/pubmed/30735139 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 2 %P e11079 %T Digital Interventions to Reduce Sedentary Behaviors of Office Workers: Scoping Review %A Huang,Yitong %A Benford,Steve %A Blake,Holly %+ Horizon Centre for Doctoral Training, University of Nottingham, B06, Computer Science, Wollaton Road, Nottingham, NG8 1BB, United Kingdom, 44 115 823255, yitong.huang@nottingham.ac.uk %K telemedicine %K sedentary behavior %K workplace %K technology %K internet %K microcomputers %D 2019 %7 07.02.2019 %9 Review %J J Med Internet Res %G English %X Background: There is a clear public health need to reduce office workers’ sedentary behaviors (SBs), especially in the workplace. Digital technologies are increasingly being deployed in the workplace to measure and modify office workers’ SBs. However, knowledge of the range and nature of research on this topic is limited; it also remains unclear to what extent digital interventions have exploited the technological possibilities. Objective: This study aimed to investigate the technological landscape of digital interventions for SB reduction in office workers and to map the research activity in this field. Methods: Terms related to SB, office worker, and digital technology were applied in various combinations to search Cochrane Library, Joanna Briggs Institute Database of Systematic Reviews, MEDLINE, PsycARTICLES, PsycINFO, Scopus, Association for Computing Machinery Digital Library, Engineering index Compendex, and Google Scholar for the years 2000 to 2017. Data regarding the study and intervention details were extracted. Interventions and studies were categorized into development, feasibility and/piloting, evaluation, or implementation phase based on the UK Medical Research Council (MRC) framework for developing and evaluating complex interventions. A novel framework was developed to classify technological features and annotate technological configurations. A mix of quantitative and qualitative approaches was used to summarize data. Results: We identified 68 articles describing 45 digital interventions designed to intervene with office workers’ SB. A total of 6 common technological features had been applied to interventions with various combinations. Configurations such as “information delivery and mediated organizational and social support” and “digital log and automated tailored feedback” were well established in evaluation and implementation studies; in contrast, the integration of passive data collection, connected devices, and ATF or scheduled prompts was mostly present in development and piloting research. Conclusions: This review is the first to map and describe the use of digital technologies in research on SB reduction in office workers. Interdisciplinary collaborations can help to maximize the potential of technologies. As novel modes of delivery that capitalize on embedded computing and electronics, wireless technologies have been developed and piloted in engineering, computing, and design fields, efforts can be directed to move them to the next phase of evaluation with more rigorous study designs. Quality of research may be improved by fostering conversations between different research communities and encouraging researchers to plan, conduct, and report their research under the MRC framework. This review will be particularly informative to those deciding on areas where further research or development is needed and to those looking to locate the relevant expertise, resources, and design inputs when designing their own systems or interventions. %M 30730294 %R 10.2196/11079 %U http://www.jmir.org/2019/2/e11079/ %U https://doi.org/10.2196/11079 %U http://www.ncbi.nlm.nih.gov/pubmed/30730294 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 2 %P e10985 %T Cardiac Rehabilitees’ Technology Experiences Before Remote Rehabilitation: Qualitative Study Using a Grounded Theory Approach %A Anttila,Marjo-Riitta %A Kivistö,Heikki %A Piirainen,Arja %A Kokko,Katja %A Malinen,Anita %A Pekkonen,Mika %A Sjögren,Tuulikki %+ Faculty of Sport and Health Sciences, University of Jyväskylä, PO Box 35, Jyväskylä,, Finland, 358 40 805 4648, marjo-riitta.m-r.anttila@jyu.fi %K coronary disease %K rehabilitees’ experience %K focus group %K qualitative study %K grounded theory %K remote rehabilitation %K e-health %K e-rehabilitation %K telerehabilitation %K secondary prevention %D 2019 %7 07.02.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Even though technology is becoming increasingly common in rehabilitation programs, insufficient data are as yet available on rehabilitees’ perceptions and experiences. It is important to understand their abilities when using technology for remote rehabilitation. Objective: This is a qualitative study on technology experiences of persons affected by cardiovascular disease assessed before remote rehabilitation. The aim of the study was to explore rehabilitees’ experiences and attitudes toward technology before 12 months of remote rehabilitation. Methods: Qualitative interviews were conducted with 39 rehabilitees in four focus groups. The subjects were aged 34 to 77 years (average age 54.8 years) and 74% (29/39) of them were male. They had been diagnosed with coronary artery disease and were undergoing treatment in a rehabilitation center. The interviews were conducted between September 2015 and November 2016. Data were analyzed using Glaser’s mode of the grounded theory approach. Results: The result of the study was an “identifying e-usage” experience category, which refers to the rehabilitees’ notions of the use of information and communication technologies (e-usage) in the process of behavior change. The main category comprises four subcategories that define the rehabilitees’ technology experience. These subcategories are “feeling outsider,” “being uninterested,” “reflecting benefit,” and “enthusiastic using.” All rehabilitees expected that technology should be simple, flexible, and easy to use and learn. The results reflecting their technology experience can be used in e-rehabilitation programs. Rehabilitees who feel like outsiders and are not interested in technology need face-to-face communication for the major part of rehabilitation, while rehabilitees who reflect benefit and are enthusiastic about the use of technology need incrementally less face-to-face interaction and feel that Web-based coaching could offer sufficient support for rehabilitation. Conclusions: The findings show that persons affected by heart disease had different experiences with technology and expectations toward counseling, while all rehabilitees expected technology to be easy to use and their experiences to be smooth and problem-free. The results can be used more widely in different contexts of social and health care for the planning of and training in remote rehabilitation counseling and education. Trial Registration: ISRCTN Registry ISRCTN61225589; http://www.isrctn.com/ISRCTN61225589 (Archived by WebCite at http://www.webcitation.org/74jmrTXFD) %M 30730298 %R 10.2196/10985 %U http://www.jmir.org/2019/2/e10985/ %U https://doi.org/10.2196/10985 %U http://www.ncbi.nlm.nih.gov/pubmed/30730298 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 2 %P e10265 %T Weight Management in Young Adults: Systematic Review of Electronic Health Intervention Components and Outcomes %A Willmott,Taylor Jade %A Pang,Bo %A Rundle-Thiele,Sharyn %A Badejo,Abi %+ Social Marketing @ Griffith, Griffith Business School, Griffith University, 170 Kessels Road, Nathan, 4111, Australia, 61 737358433, t.willmott@griffith.edu.au %K body weight maintenance %K eHealth %K health behavior %K obesity %K overweight %K review %K technology %K weight gain %K young adult %D 2019 %7 06.02.2019 %9 Review %J J Med Internet Res %G English %X Background: Young adulthood is a vulnerable period for unhealthy lifestyle adoption and excess weight gain. Scant attention has been focused on developing and evaluating effective weight gain prevention strategies for this age group. Electronic health (eHealth) offers potential as a cost-effective means of delivering convenient, individually-tailored, and contextually-meaningful interventions at scale. Objective: The primary aim of this systematic review was to locate and synthesize the evidence on eHealth weight management interventions targeting young adults, with a particular focus on (eHealth) intervention components and outcomes. Methods: A systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The search strategy was executed across the following electronic databases: Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, EBSCO, EMBASE, Emerald, Education Resources Information Center, Medical Literature Analysis and Retrieval System Online, Ovid, ProQuest, PsycINFO, PubMed, Science Direct, Scopus, and Web of Science. Furthermore, 2 reviewers independently assessed records for eligibility: peer-reviewed, published in English, and report evaluations of eHealth weight management interventions targeting healthy young adults (aged 18-35 years). Data were then extracted from studies that met the criteria for inclusion. The methodological quality of studies was independently assessed by 2 reviewers using the Effective Public Health Practice Project’s (EPHPP) quality assessment tool. A comprehensive narrative evidence synthesis was then completed. Results: Out of the 1301 studies assessed for eligibility, 24 met the criteria for inclusion. According to the EPHPP quality assessment tool, overall, 19 studies were as rated weak, 5 as moderate, and none as strong. The narrative synthesis of intervention outcomes found 8 studies reported positive weight-related outcomes, 4 reported mixed outcomes, and 12 did not report any significant changes in weight-related outcomes. The narrative synthesis of (eHealth) intervention components led to 3 levels of classification. A total of 14 studies were classified as Web-based, 3 as mobile-based, and 7 as multicomponent interventions. Following the narrative synthesis, 5 key strategies were thematically identified: self-regulation (goal setting and self-monitoring), tailored or personalized feedback, contact with an interventionist, social support, and behavioral prompts (nudges and reminders) and booster messages. Conclusions: Findings highlight the limited evidence base for eHealth weight management interventions targeting young adults. The complex nature of weight management presents an ongoing challenge for interventionists to identify what works, for whom, how, and when. The quality of the evidence in this review was generally assessed as weak; however, assessment tools such as the EPHPP are principally concerned with what should be and this is seldom equivalent to what works. Thus, while sampling, study design and retention rates will remain key determining factors of reliability and validity, further research attention directed toward the development of guiding tools for community trials is warranted. %M 30724736 %R 10.2196/10265 %U http://www.jmir.org/2019/2/e10265/ %U https://doi.org/10.2196/10265 %U http://www.ncbi.nlm.nih.gov/pubmed/30724736 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 2 %P e9938 %T Electronic Health Program to Empower Patients in Returning to Normal Activities After General Surgical and Gynecological Procedures: Intervention Mapping as a Useful Method for Further Development %A den Bakker,Chantal M %A Schaafsma,Frederieke G %A van der Meij,Eva %A Meijerink,Wilhelmus JHJ %A van den Heuvel,Baukje %A Baan,Astrid H %A Davids,Paul HP %A Scholten,Petrus C %A van der Meij,Suzan %A van Baal,W Marchien %A van Dalsen,Annette D %A Lips,Daniel J %A van der Steeg,Jan Willem %A Leclercq,Wouter KG %A Geomini,Peggy MAJ %A Consten,Esther CJ %A Schraffordt Koops,Steven E %A de Castro,Steve MM %A van Kesteren,Paul JM %A Cense,Huib A %A Stockmann,Hein BAC %A ten Cate,A Dorien %A Bonjer,Hendrik J %A Huirne,Judith AF %A Anema,Johannes R %+ Amsterdam Public Health Research Institute, Department of Occupational and Public Health, VU University Medical Center, Van der Boechorststraat 7, Amsterdam, 1081 BT, Netherlands, 31 204445703, c.denbakker@vumc.nl %K intervention mapping %K eHealth %K return to normal activities %K return to work %K patient reported outcome measures %K colectomy %K hysterectomy %D 2019 %7 06.02.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Support for guiding and monitoring postoperative recovery and resumption of activities is usually not provided to patients after discharge from the hospital. Therefore, a perioperative electronic health (eHealth) intervention (“ikherstel” intervention or “I recover” intervention) was developed to empower gynecological patients during the perioperative period. This eHealth intervention requires a need for further development for patients who will undergo various types of general surgical and gynecological procedures. Objective: This study aimed to further develop the “ikherstel” eHealth intervention using Intervention Mapping (IM) to fit a broader patient population. Methods: The IM protocol was used to guide further development of the “ikherstel” intervention. First, patients’ needs were identified using (1) the information of a process evaluation of the earlier performed “ikherstel” study, (2) a review of the literature, (3) a survey study, and (4) focus group discussions (FGDs) among stakeholders. Next, program outcomes and change objectives were defined. Third, behavior change theories and practical tools were selected for the intervention program. Finally, an implementation and evaluation plan was developed. Results: The outcome for an eHealth intervention tool for patients recovering from abdominal general surgical and gynecological procedures was redefined as “achieving earlier recovery including return to normal activities and work.” The Attitude-Social Influence-Self-Efficacy model was used as a theoretical framework to transform personal and external determinants into change objectives of personal behavior. The knowledge gathered by needs assessment and using the theoretical framework in the preparatory steps of the IM protocol resulted in additional tools. A mobile app, an activity tracker, and an electronic consultation (eConsult) will be incorporated in the further developed eHealth intervention. This intervention will be evaluated in a multicenter, single-blinded randomized controlled trial with 18 departments in 11 participating hospitals in the Netherlands. Conclusions: The intervention is extended to patients undergoing general surgical procedures and for malignant indications. New intervention tools such as a mobile app, an activity tracker, and an eConsult were developed. Trial Registration: Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5686  %M 30724740 %R 10.2196/jmir.9938 %U https://www.jmir.org/2019/2/e9938/ %U https://doi.org/10.2196/jmir.9938 %U http://www.ncbi.nlm.nih.gov/pubmed/30724740 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 2 %P e11128 %T Design and Delivery Features That May Improve the Use of Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Anxiety: A Realist Literature Synthesis With a Persuasive Systems Design Perspective %A Radomski,Ashley D %A Wozney,Lori %A McGrath,Patrick %A Huguet,Anna %A Hartling,Lisa %A Dyson,Michele P %A Bennett,Kathryn %A Newton,Amanda S %+ Department of Pediatrics, University of Alberta, 3-526 Edmonton Clinic Health Academy, 11405 - 87 Avenue, Edmonton, AB, T6G 1C9, Canada, 1 780 248 5581, mandi.newton@ualberta.ca %K internet %K cognitive behavioral therapy %K computer-assisted therapy %K persuasive communication %K anxiety %K children %K adolescents %K review %K adherence %D 2019 %7 05.02.2019 %9 Review %J J Med Internet Res %G English %X Background: Internet-based cognitive behavioral therapy (iCBT) is a persuasive system as its design combines therapeutic content, technological features, and interactions between the user and the program to reduce anxiety for children and adolescents. How iCBT is designed and delivered differs across programs. Although iCBT is considered an effective approach for treating child and adolescent anxiety, rates of program use (eg, module completion) are highly variable for reasons that are not clear. As the extent to which users complete a program can impact anxiety outcomes, understanding what iCBT design and delivery features improve program use is critical for optimizing treatment effects. Objective: The objectives of this study were to use a realist synthesis approach to explore the design and delivery features of iCBT for children and adolescents with anxiety as described in the literature and to examine their relationship to program use outcomes. Methods: A search of published and gray literature was conducted up to November 2017. Prespecified inclusion criteria identified research studies, study protocols, and program websites on iCBT for child and adolescent anxiety. Literature was critically appraised for relevance and methodological rigor. The persuasive systems design (PSD) model, a comprehensive framework for designing and evaluating persuasive systems, was used to guide data extraction. iCBT program features were grouped under 4 PSD categories—Primary task support, Dialogue support, System credibility support, and Social support. iCBT design (PSD Mechanisms) and delivery features (Context of use) were linked to program use (Outcomes) using meta-ethnographic methods; these relationships were described as Context-Mechanism-Outcome configurations. For our configurations, we identified key PSD features and delivery contexts that generated moderate-to-high program use based on moderate-to-high quality evidence found across multiple iCBT programs. Results: A total of 44 documents detailing 10 iCBT programs were included. Seven iCBT programs had at least one document that scored high for relevance; most studies were of moderate-to-high methodological rigor. We developed 5 configurations that highlighted 8 PSD features (Tailoring, Personalization [Primary task supports]; Rewards, Reminders, Social role [Dialogue supports]; and Trustworthiness, Expertise, Authority [System credibility supports]) associated with moderate-to-high program use. Important features of delivery Context were adjunct support (a face-to-face, Web- or email-based communications component) and whether programs targeted the prevention or treatment of anxiety. Incorporating multiple PSD features may have additive or synergistic effects on program use. Conclusions: The Context-Mechanism-Outcome configurations we developed suggest that, when delivered with adjunct support, certain PSD features contribute to moderate-to-high use of iCBT prevention and treatment programs for children and adolescents with anxiety. Standardization of the definition and measurement of program use, formal testing of individual and combined PSD features, and use of real-world design and testing methods are important next steps to improving how we develop and deliver increasingly useful treatments to target users. %M 30720436 %R 10.2196/11128 %U https://www.jmir.org/2019/2/e11128/ %U https://doi.org/10.2196/11128 %U http://www.ncbi.nlm.nih.gov/pubmed/30720436 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 1 %P e10674 %T Electronic Health Program to Empower Patients in Returning to Normal Activities After Colorectal Surgical Procedures: Mixed-Methods Process Evaluation Alongside a Randomized Controlled Trial %A den Bakker,Chantal M %A Huirne,Judith AF %A Schaafsma,Frederieke G %A de Geus,Charlotte %A Bonjer,Hendrik J %A Anema,Johannes R %+ Department of Occupational and Public Health, Amsterdam Public Health Research Institute, VU University Medical Center, Van der Boechorststraat 7, Amsterdam, 1081 BT, Netherlands, 31 20 4445703, c.denbakker@vumc.nl %K return to normal activities %K return to work %K patient reported outcome measures %K colectomy %K process evaluation %D 2019 %7 29.01.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Long-term recovery takes longer than expected despite improved surgical techniques and Enhanced Recovery After Surgery programs. An electronic health (eHealth) care program (“ikherstel”) was developed to partially substitute perioperative care for patients undergoing colorectal surgical procedures. Successfully tested eHealth programs are not always implemented in usual care, and it is, therefore, important to evaluate the process to optimize future implementation. Objective: The aim of this study was to evaluate whether the eHealth intervention was executed as planned. Methods: A mixed-methods process evaluation was carried out alongside a multicenter randomized controlled trial (RCT). This evaluation was performed using the Linnan and Steckler framework for the quantitative part of this study, measuring the components reach, dose delivered, dose received, fidelity, and participants’ attitudes. Total implementation scores were calculated using the averaging approach, in which the sum of all data points is divided by the number of data points and the total adherence to the protocol is measured. For the qualitative part, the Unified Theory of Acceptance and Use of Technology framework was used. The quantitative data were based on participants’ questionnaires, a logistic database, a weblog, and participants’ medical files and were obtained by performing semistructured interviews with participants of the RCT. Results: A total of 151 participants of 340 eligible patients were included in the RCT, of which 73 participants were allocated to the intervention group. On the basis of the quantitative process data, total implementation scores for the website, mobile app, electronic consult, and activity tracker were 64%, 63%, 44%, and 67%, respectively. Participants in the qualitative part experienced the program as supportive and provided guidance on their recovery process after colorectal surgery. Most frequently mentioned barriers were the limited interaction with and feedback from health care professionals and the lack of tailoring of the convalescence plan in case of a different course of recovery. Conclusions: The intervention needs more interaction with and feedback from health care professionals and needs more tailored guidance in case of different recovery or treatment courses. To ensure a successful implementation of the program in daily practice, some adjustments are required to optimize the program in a blended care form. Trial Registration: Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC= 5686 (Archieved by WebCite at http://www.webcitation.org/75LrJaHrr) %M 30694205 %R 10.2196/10674 %U http://www.jmir.org/2019/1/e10674/ %U https://doi.org/10.2196/10674 %U http://www.ncbi.nlm.nih.gov/pubmed/30694205 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 1 %P e12530 %T Internet-Delivered Acceptance and Commitment Therapy for Anxiety Treatment: Systematic Review %A Kelson,Joshua %A Rollin,Audrey %A Ridout,Brad %A Campbell,Andrew %+ Cyberpsychology Research Group, Faculty of Health Sciences, The University of Sydney, City Road, Sydney, 2006, Australia, 61 2 9351 7089, joshnkelson@gmail.com %K anxiety %K anxiety disorders %K acceptance and commitment therapy %K mindfulness %K telemedicine %K internet %K e-therapy %D 2019 %7 29.01.2019 %9 Review %J J Med Internet Res %G English %X Background: Anxiety conditions are debilitating and prevalent throughout the world. Acceptance and Commitment Therapy (ACT) is an effective, acceptance-based behavioral therapy for anxiety. However, there are treatment barriers (eg, financial, geographical, and attitudinal), which prevent people from accessing it. To overcome these barriers, internet-delivered ACT (iACT) interventions have been developed in recent years. These interventions use websites to deliver ACT information and skill training exercises on the Web, either as pure self-help or with therapist guidance. Objective: This systematic review aimed to examine the therapeutic impact of iACT on all anxiety conditions. Methods: The EMBASE, MEDLINE, ProQuest Central, PsycINFO, Scopus, and Web of Science databases were searched up to September 2018. The titles and abstracts of remaining records after deduplication were screened by 2 authors with a total of 36 full-text articles being retained for closer inspection next to eligibility criteria. Empirical studies of all designs, population types, and comparator groups were included if they appraised the impact of iACT treatment on any standardized measure of anxiety. Included studies were appraised on methodological quality and had their data extracted into a standardized coding sheet. Findings were then tabulated, and a narrative synthesis was performed because of the heterogeneity found between studies. Results: A total of 20 studies met inclusion criteria. There were 11 randomized controlled trials (RCTs) and 9 uncontrolled pilot studies. Participants across all studies were adults. The anxiety conditions treated were as follows: generalized anxiety disorder (GAD), social anxiety disorder (SAD), illness anxiety disorder (IAD), and general anxiety symptoms, with or without comorbid physical and mental health problems. A total of 18 studies reported significant anxiety reduction after iACT treatment. This was observed in studies that delivered iACT with (n=13) or without (n=5) therapist guidance. The average attrition rate across all included studies during the active iACT treatment phase was 19.19%. In the 13 studies that assessed treatment satisfaction, participants on average rated their iACT experience with above average to high treatment satisfaction. Conclusions: These findings indicate that iACT can be an efficacious and acceptable treatment for adults with GAD and general anxiety symptoms. More RCT studies are needed to corroborate these early iACT findings using empirical treatments in active control groups (eg, internet-delivered cognitive behavioral therapy). This would potentially validate the promising results found for SAD and IAD as well as address the full spectrum of anxiety disorders. %M 30694201 %R 10.2196/12530 %U http://www.jmir.org/2019/1/e12530/ %U https://doi.org/10.2196/12530 %U http://www.ncbi.nlm.nih.gov/pubmed/30694201 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 1 %P e10353 %T Mobile Apps for Management of Tinnitus: Users’ Survey, Quality Assessment, and Content Analysis %A Sereda,Magdalena %A Smith,Sandra %A Newton,Kiri %A Stockdale,David %+ National Institute for Health Research Nottingham Biomedical Research Centre, Ropewalk House, 113 The Ropewalk, Nottingham, NG1 5DU, United Kingdom, 44 1158232600, Magdalena.Sereda@nottingham.ac.uk %K tinnitus %K mobile apps %K disease management %K surveys and questionnaires %K Mobile Apps Rating Scale %D 2019 %7 23.01.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Tinnitus is the perception of a sound without any outside source. It affects 6 million people in the United Kingdom. Sound therapy is a core component of many tinnitus management programs. Potential mechanisms of benefit include making tinnitus less noticeable, habituation, distracting attention from tinnitus, relaxation, and promoting neuroplastic changes within the brain. In recent years, there has been a substantial increase in the use of mobile technology. This provided an additional medium through which people with tinnitus can access different tinnitus management options, including sound therapy. Objective: The aim of this study was to (1) generate the list of apps that people use for management of their tinnitus, (2) explore reasons for app use and nonuse, (3) perform quality assessment of the most cited apps, and (4) perform content analysis to explore and describe options and management techniques available in the most cited apps. Methods: A Web-based survey consisting of 33 open and closed questions captured (1) demographic information, information about tinnitus, and hearing loss and (2) mobile app–specific information about the motivation to use an app, the apps which respondents used for tinnitus, important factors when choosing an app, devices used to access apps, and reasons for not using apps. The quality of the most cited apps was assessed using the Mobile Apps Rating Scale (MARS). Content and features of the most cited apps were analyzed. Results: Data from 643 respondents were analyzed. The majority of respondents (482/643, 75.0%) had never used an app for management of tinnitus mainly because of lack of awareness (381/643, 59.3%). The list of the 55 apps that people use for their tinnitus was generated. These included apps that were developed specifically for the management of tinnitus; however, the majority of cited apps were developed for other problems (eg, sleep, depression or anxiety, and relaxation). Quality assessment of the 18 most popular apps using MARS resulted in a range of mean scores from 1.6 to 4.2 (out of 5). In line with the current model of tinnitus management, sound was the main focus of the majority of the apps. Other components included relaxation exercises, elements of cognitive behavioral therapy, information and education, and hypnosis. Conclusions: People used apps for the management of their tinnitus; however, this was done mostly as a self-help option, without conjunction with management provided by hearing health care professionals. Further research should consider the place for apps in tinnitus management (stand-alone self-management intervention vs part of the management by a hearing professional). As the content of the apps varies with respect to sound options, information, and management strategies, it seems that the choice of the best management app should be guided by individual patient’s needs and preferences. %M 30672739 %R 10.2196/10353 %U http://mhealth.jmir.org/2019/1/e10353/ %U https://doi.org/10.2196/10353 %U http://www.ncbi.nlm.nih.gov/pubmed/30672739 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 2 %N 1 %P e12199 %T Feasibility and Acceptability of Technology-Based Exercise and Posture Training in Older Adults With Age-Related Hyperkyphosis: Pre-Post Study %A Katzman,Wendy B %A Gladin,Amy %A Lane,Nancy E %A Wong,Shirley %A Liu,Felix %A Jin,Chengshi %A Fukuoka,Yoshimi %+ Department of Physical Therapy and Rehabilitation Science, University of California, San Francisco, 1500 Owens Street, Suite 400, San Francisco, CA, 94158, United States, 1 415 514 6776, wendy.katzman@ucsf.edu %K acceptability %K exercise %K feasibility %K hyperkyphosis %K kyphosis %K posture %K spine %K technology-based %D 2019 %7 21.01.2019 %9 Original Paper %J JMIR Aging %G English %X Background: Hyperkyphosis is common among older adults and is associated with multiple adverse health outcomes. Kyphosis-specific exercise and posture training programs improve hyperkyphosis, but in-person programs are expensive to implement and maintain over long periods. It is unclear if a technology-based posture training program disseminated through a mobile phone is a feasible or acceptable alternative to in-person training among older adults with hyperkyphosis. Objective: The primary purpose was to assess the feasibility of subject recruitment, short-term retention and adherence, and acceptability of a technology-based exercise and posture training program disseminated as video clip links and text messaging prompts via a mobile phone. The secondary purpose was to explore the potential efficacy of this program for kyphosis, physical function, and health-related quality of life in older adults with hyperkyphosis. Methods: In this 6-week pre-post design pilot trial, we recruited community-dwelling adults aged ≥65 years with hyperkyphosis ≥40° (±5°) and access to a mobile phone. The intervention had two parts: (1) exercise and posture training via video clips sent to participants daily via text messaging, including 6 weekly video clip links to be viewed on the participant’s mobile phone, and (2) text messaging prompts to practice good posture. We analyzed the subject recruitment, adherence, retention, and acceptability of the intervention. Outcomes included change in kyphometer-measured kyphosis, occiput-to-wall (OTW) distance, Short Physical Performance Battery score, Scoliosis Research Society (SRS-30) score, Center for Epidemiological Studies Depression score, and Physical Activity Scale for the Elderly (PASE) score. Results: A total of 64 potential participants were recruited, 17 were enrolled, and 12 completed postintervention testing at 6 weeks. The average age was 71.6 (SD 4.9) years, and 50% were women. The median adherence to daily video viewing was 100% (range, 14%-100%) and to practicing good posture at least three times per day was 71% (range, 0%-100%). Qualitative evaluation of intervention acceptability revealed that the mobile phone screen was too small for participants to view the videos well and daily prompts to practice posture were too frequent. Kyphosis, OTW distance, and physical activity significantly improved after the 6-week intervention. Kyphosis decreased by 8° (95% CI –12 to –5; P<.001), OTW decreased by 1.9 cm (95% CI –3.3 to –0.7; P=.007), and physical activity measured by PASE increased by 29 points (95% CI 3 to 54; P=.03). The health-related quality of life SRS-30 score increased by 0.11 point (SD 0.19), but this increase was not statistically significant (P=.09). Conclusions: Technology-based exercise and posture training using video clip viewing and text messaging reminders is feasible and acceptable for a small cohort of older adults with hyperkyphosis. Technology-based exercise and posture training warrants further study as a potential self-management program for age-related hyperkyphosis, which may be more easily disseminated than in-person training. %M 31363712 %R 10.2196/12199 %U http://aging.jmir.org/2019/1/e12199/ %U https://doi.org/10.2196/12199 %U http://www.ncbi.nlm.nih.gov/pubmed/31363712 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 1 %P e9955 %T Informing Adults With Back Pain About Placebo Effects: Randomized Controlled Evaluation of a New Website With Potential to Improve Informed Consent in Clinical Research %A Bishop,Felicity L %A Greville-Harris,Maddy %A Bostock,Jennifer %A Din,Amy %A Graham,Cynthia A %A Lewith,George %A Liossi,Christina %A O'Riordan,Tim %A White,Peter %A Yardley,Lucy %+ Department of Psychology, University of Southampton, Building 44, Highfield Campus, University Road, Southampton,, United Kingdom, 44 2380599020, f.l.bishop@southampton.ac.uk %K placebos %K placebo effects %K informed consent %K research ethics %K health knowledge, attitudes, practice %K internet %D 2019 %7 17.01.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Placebo effects and their underpinning mechanisms are increasingly well understood. However, this is poorly communicated to participants in placebo-controlled trials. For valid informed consent, participants should be informed about the potential benefits and risks of participating in placebo-controlled trials. Existing information leaflets often fail to describe the potential benefits and adverse effects associated with placebo allocation. This study tested the effects of a new website designed to inform patients about placebo effects (The Power of Placebos, PoP). PoP was designed using qualitative methods in combination with theory- and evidence-based approaches to ensure it was engaging, informative, and addressed patients’ concerns. Objective: This study aimed to test the effects of PoP, compared with a control website, on people’s knowledge about placebo and the ability to make an informed choice about taking part in a placebo-controlled trial. Methods: A total of 350 adults with back pain recruited from 26 general practices in Southern England participated in this Web-based study. Participants were randomly assigned to PoP (which presented scientifically accurate information about placebo effects in an engaging way) or a control website (based on existing information leaflets from UK trials). Participants self-completed Web-based pre- and postintervention questionnaire measures of knowledge about placebo effects and preintervention questionnaire measures of attitudes toward and intentions to participate in a placebo-controlled trial. The 2 primary outcomes were (1) knowledge and (2) informed choice to take part in a placebo-controlled trial (computed from knowledge, attitudes, and intentions). Results: After viewing PoP, participants had significantly greater knowledge about placebos (mean 8.28 [SD 1.76]; n=158) than participants who viewed the control (mean 5.60 [SD 2.24]; n=174; F1,329=173.821; P<.001; η2=.346). Participants who viewed PoP were 3.16 times more likely than those who viewed the control to make an informed choice about placebos (χ21=36.5; P<.001). Conclusions: In a sample of adults with back pain, PoP increased knowledge and rates of informed choice about placebos compared with a control website. PoP could be used to improve knowledge about placebo effects in back pain. After essential further development and testing in clinical trial settings, it could support informed consent in placebo-controlled trials. %M 30664462 %R 10.2196/jmir.9955 %U https://www.jmir.org/2019/1/e9955/ %U https://doi.org/10.2196/jmir.9955 %U http://www.ncbi.nlm.nih.gov/pubmed/30664462 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 1 %P e10868 %T A Novel Insight Into the Challenges of Diagnosing Degenerative Cervical Myelopathy Using Web-Based Symptom Checkers %A Davies,Benjamin Marshall %A Munro,Colin Fraser %A Kotter,Mark RN %+ Academic Neurosurgery Unit, Department of Clinical Neurosciences, University of Cambridge, ED Adrian Building, Forvie Site, Robinson Way, Cambridge, CB2 2PY, United Kingdom, 44 7887790773, mrk25@cam.ac.uk %K cord compression %K degenerative cervical myelopathy %K diagnosis %K differential %K spondylosis %D 2019 %7 11.01.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Degenerative cervical myelopathy (DCM) is a common debilitating condition resulting from degeneration of the cervical spine. While decompressive surgery can halt disease progression, existing spinal cord damage is often permanent, leaving patients with lifelong disability. Early surgery improves the likelihood of recovery, yet the average time from the onset of symptoms to correct diagnosis is over 2 years. The majority of delays occur initially, before and within primary care, mainly due to a lack of recognition. Symptom checkers are widely used by patients before medical consultation and can be useful for preliminary triage and diagnosis. Lack of recognition of DCM by symptom checkers may contribute to the delay in diagnosis. Objective: The aims of this study were to investigate whether Web-based symptom checkers were able to recognize relevant symptoms of DCM, to characterize the DCM differential they returned , and to evaluate the diagnostic performance of recognized DCM symptoms. Methods: We pooled classical DCM symptoms from leading review articles. These symptoms were entered into the algorithms used by the top 20 symptom checker websites (N=4; Google Search). The most widely cited symptom checker, WebMD, was used to characterize the differential diagnosis for DCM symptoms. Results: A total of 31 classical DCM symptoms were identified, of which 45% (14/31) listed DCM as a differential and 10% (3/31) placed DCM in the top third of the differential. The mean differential rank for motor symptoms was significantly better than that for arthritic symptoms (P=.01) and the average differential rank for all symptoms (P=.048). The symptom checker WebMD performed best at recognizing DCM, placing the condition nearer to the top of the differential list (mean rank of 5.6) than either Healthline (rank of 12.9, P=.02) or Healthtools.AARP (rank of 15.5, P=.001). On WebMD, only one combination of symptoms resulted in DCM as the primary differential: neck, shoulder, and arm pain with hand weakness. Moreover, 151 differential diagnoses for DCM symptoms were recorded on WebMD. Multiple sclerosis and peripheral neuropathy were the most common differentials, shortlisted for 52% (16/31) and 32% (10/31) of the DCM symptoms, respectively. Conclusions: DCM symptoms are poorly identified by Web-based symptom checkers, which leads to a large differential of many other common conditions. While a diagnosis becomes more likely as the number of symptoms increases, this represents more advanced disease and will not support much-needed earlier diagnosis. Symptom checkers remain an attractive concept with potential. Further research is required to support their optimization. %M 30300137 %R 10.2196/10868 %U http://www.jmir.org/2019/1/e10868/ %U https://doi.org/10.2196/10868 %U http://www.ncbi.nlm.nih.gov/pubmed/30300137 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 1 %P e11566 %T Evaluating a Web-Based Social Anxiety Intervention Among Community Users: Analysis of Real-World Data %A McCall,Hugh Cameron %A Helgadottir,Fjola Dogg %A Menzies,Ross G %A Hadjistavropoulos,Heather D %A Chen,Frances S %+ AI-Therapy, 5515 Stellar Place, North Vancouver, BC, V7R 4N3, Canada, 1 604 652 5440, fjola@ai-therapy.com %K social anxiety %K internet %K cognitive behavioral therapy %K psychotherapy %K mental health %D 2019 %7 10.01.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Social anxiety is both harmful and prevalent. It also currently remains among the most undertreated major mental disorders, due, in part, to socially anxious individuals’ concerns about the stigma and expense of seeking help. The privacy and affordability of computer-aided psychotherapy interventions may render them particularly helpful in addressing these concerns, and they are also highly scalable, but most tend to be only somewhat effective without therapist support. However, a recent evaluation of a new self-guided, 7-module internet-delivered cognitive behavioral therapy intervention called Overcome Social Anxiety found that it was highly effective. Objective: The initial evaluation of Overcome Social Anxiety revealed that it led to significant reductions in symptom severity among university undergraduates. The aim of this study was to extend the results of the initial study and investigate their generalizability by directly evaluating the intervention’s effectiveness among a general community sample. Methods: While signing up for Overcome Social Anxiety, users consented to the usage of their anonymized outcome data for research purposes. Before and after completing the intervention, users completed the Fear of Negative Evaluation Scale (FNE), which we employed as the primary outcome measure. Secondary outcome measures included the Depression Anxiety Stress Scales (DASS) and 2 bespoke questionnaires measuring socially anxious thoughts (Thoughts Questionnaire) and avoidance behaviors (Avoidance Questionnaire). Results: Participants who completed the intervention (102/369, 27.7%) experienced significant reductions in the severity of their symptoms on all measures employed, including FNE (P<.001; Cohen d=1.76), the depression subscale of DASS (P<.001; Cohen d=0.70), the anxiety subscale of DASS (P<.001; Cohen d=0.74), the stress subscale of DASS (P<.001; Cohen d=0.80), the Thoughts Questionnaire (P<.001; Cohen d=1.46), and the Avoidance Questionnaire (P<.001; Cohen d=1.42). Conclusions: Our results provide further evidence that Overcome Social Anxiety reduces the severity of social anxiety symptoms among those who complete it and suggest that its effectiveness extends to the general community. The completion rate is the highest documented for a fully automated intervention for anxiety, depression, or low mood in a real community sample. In addition, our results indicate that Overcome Social Anxiety reduces the severity of symptoms of depression, physiological symptoms of anxiety, and stress in addition to symptoms of social anxiety. %M 30632965 %R 10.2196/11566 %U http://www.jmir.org/2019/1/e11566/ %U https://doi.org/10.2196/11566 %U http://www.ncbi.nlm.nih.gov/pubmed/30632965 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 1 %P e10421 %T Identifying Brief Message Content for Interventions Delivered via Mobile Devices to Improve Medication Adherence in People With Type 2 Diabetes Mellitus: A Rapid Systematic Review %A Long,Hannah %A Bartlett,Yvonne K %A Farmer,Andrew J %A French,David P %+ Manchester Centre for Health Psychology, School of Health Sciences, University of Manchester, Coupland 1 Building, Coupland Street, Manchester, M13 9PL, United Kingdom, 44 161 275 2605, david.french@manchester.ac.uk %K medication adherence %K diabetes mellitus %K systematic review %K text messaging %K mHealth %K self-management %D 2019 %7 09.01.2019 %9 Review %J J Med Internet Res %G English %X Background: Current interventions to support medication adherence in people with type 2 diabetes are generally resource-intensive and ineffective. Brief messages, such as those delivered via short message service (SMS) systems, are increasingly used in digital health interventions to support adherence because they can be delivered on a wide scale and at low cost. The content of SMS text messages is a crucial intervention feature for promoting behavior change, but it is often unclear what the rationale is for chosen wording or any underlying mechanisms targeted for behavioral change. There is little guidance for developing and optimizing brief message content for use in mobile device–delivered interventions. Objective: This review aimed to (1) identify theoretical constructs (ie, the targets that interventions aim to change) and behavioral strategies (ie, features of intervention content) found to be associated with medication adherence in patients with type 2 diabetes and (2) map these onto a standard taxonomy for behavior change techniques (BCTs, that is, active ingredients of interventions used to promote behavioral change, to produce an evidence-based set of approaches that have shown promise of improving adherence in previous studies and which could be further tested in digital health interventions. Methods: A rapid systematic review of existing relevant systematic reviews was conducted. MEDLINE and PsycINFO databases were searched from inception to April 10, 2017. Inclusion criteria were (1) systematic reviews of quantitative data if the studies reviewed identified predictors of or correlates with medication adherence or evaluated medication adherence–enhancing interventions and included adult participants taking medication to manage a chronic physical health condition, and (2) systematic reviews of qualitative studies of experiences of medication adherence for adult participants with type 2 diabetes. Data were extracted on review characteristics and BCTs, theoretical constructs, or behavioral strategies associated with improved adherence. Constructs and strategies were mapped onto the BCT version 1 taxonomy. Results: A total of 1701 references were identified; 25 systematic reviews (19 quantitative reviews, 3 qualitative reviews, and 3 mixed-method reviews) were included. Moreover, 20 theoretical constructs (eg, self-efficacy) and 19 behavioral strategies (eg, habit analysis) were identified in the included reviews. In total, 46 BCTs were identified as being related to medication adherence in type 2 diabetes (eg, habit formation, prompts or cues, and information about health consequences). Conclusions: We identified 46 promising BCTs related to medication adherence in type 2 diabetes on which the content of brief messages delivered through mobile devices to improve adherence could be based. By using explicit systematic review methods and linking our findings to a standardized taxonomy of BCTs, we have described a novel approach for the development of digital message content. Future brief message interventions that aim to support medication adherence could incorporate the identified BCTs. %M 30626562 %R 10.2196/10421 %U https://www.jmir.org/2019/1/e10421/ %U https://doi.org/10.2196/10421 %U http://www.ncbi.nlm.nih.gov/pubmed/30626562 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 1 %P e298 %T Web-Based Digital Health Interventions for Weight Loss and Lifestyle Habit Changes in Overweight and Obese Adults: Systematic Review and Meta-Analysis %A Beleigoli,Alline M %A Andrade,Andre Q %A Cançado,Alexandre G %A Paulo,Matheus NL %A Diniz,Maria De Fátima H %A Ribeiro,Antonio L %+ Internal Medicine Department, Faculty of Medicine, Universidade Federal de Minas Gerais, Avenida Professor Alfredo Balena, 190 Santa Efigenia, Belo Horizonte, 30130100, Brazil, 55 3134099746, abeleigoli@gmail.com %K internet %K mobile phone %K meta-analysis %K obesity %K telemedicine %D 2019 %7 08.01.2019 %9 Review %J J Med Internet Res %G English %X Background: Obesity is a highly prevalent condition with important health implications. Face-to-face interventions to treat obesity demand a large number of human resources and time, generating a great burden to individuals and health system. In this context, the internet is an attractive tool for delivering weight loss programs due to anonymity, 24-hour-accessibility, scalability, and reachability associated with Web-based programs. Objective: We aimed to investigate the effectiveness of Web-based digital health interventions, excluding hybrid interventions and non-Web-based technologies such as text messaging, short message service, in comparison to nontechnology active or inactive (wait list) interventions on weight loss and lifestyle habit changes in individuals with overweight and obesity. Methods: We searched PubMed or Medline, SciELO, Lilacs, PsychNet, and Web of Science up to July 2018, as well as references of previous reviews for randomized trials that compared Web-based digital health interventions to offline interventions. Anthropometric changes such as weight, body mass index (BMI), waist, and body fat and lifestyle habit changes in adults with overweight and obesity were the outcomes of interest. Random effects meta-analysis and meta-regression were performed for mean differences (MDs) in weight. We rated the risk of bias for each study and the quality of evidence across studies using the Grades of Recommendation, Assessment, Development, and Evaluation approach. Results: Among the 4071 articles retrieved, 11 were included. Weight (MD −0.77 kg, 95% CI −2.16 to 0.62; 1497 participants; moderate certainty evidence) and BMI (MD −0.12 kg/m2; 95% CI −0.64 to 0.41; 1244 participants; moderate certainty evidence) changes were not different between Web-based and offline interventions. Compared to offline interventions, digital interventions led to a greater short-term (<6 months follow-up) weight loss (MD −2.13 kg, 95% CI −2.71 to −1.55; 393 participants; high certainty evidence), but not in the long-term (MD −0.17 kg, 95% CI −2.10 to 1.76; 1104 participants; moderate certainty evidence). Meta-analysis was not possible for lifestyle habit changes. High risk of attrition bias was identified in 5 studies. For weight and BMI outcomes, the certainty of evidence was moderate mainly due to high heterogeneity, which was mainly attributable to control group differences across studies (R2=79%). Conclusions: Web-based digital interventions led to greater short-term but not long-term weight loss than offline interventions in overweight and obese adults. Heterogeneity was high across studies, and high attrition rates suggested that engagement is a major issue in Web-based interventions. %M 30622090 %R 10.2196/jmir.9609 %U https://www.jmir.org/2019/1/e298/ %U https://doi.org/10.2196/jmir.9609 %U http://www.ncbi.nlm.nih.gov/pubmed/30622090 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 1 %P e11250 %T Web-Based Exercise as an Effective Complementary Treatment for Patients With Nonalcoholic Fatty Liver Disease: Intervention Study %A Pfirrmann,Daniel %A Huber,Yvonne %A Schattenberg,Jörn Markus %A Simon,Perikles %+ Department of Sports Medicine, Disease Prevention and Rehabilitation, Institute of Sports Science, Johannes Gutenberg University, Johann-Joachim-Becher-Weg 31, Mainz, 55099, Germany, 49 6131 ext 3923586, simonpe@uni-mainz.de %K exercise %K fatty liver %K lifestyle %K NAFLD %K treatment %K Web-based %D 2019 %7 02.01.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Physical inactivity is a major risk factor for nonalcoholic fatty liver disease (NAFLD). Exercise-based prevention interventions for improving cardiorespiratory fitness are a recommended complementary treatment for NAFLD. Achievement of minimally effective physical activity to improve cardiorespiratory fitness among patients typically involves high personal and financial expenses in face-to-face settings. We designed an eHealth approach for patients with NAFLD to improve the cardiorespiratory fitness and report the first results of the HELP (Hepatic Inflammation and Physical Performance in Patients With NASH [nonalcoholic steatohepatitis]) study. Objective: We aimed to assess the effectiveness of an 8-week, tailored, Web-based exercise intervention for cardiorespiratory fitness improvement, expressed as peak oxygen uptake (peak volume of oxygen [VO2peak]), in patients with histologically confirmed NAFLD. Methods: In a 24-month period, 44 patients were enrolled into an 8-week, prospective, single-arm study with 12 weeks of follow-up. After a medical examination and performance diagnostics, a sports therapist introduced the patients to a Web-based platform for individualized training support. Regular individual patient feedback was provided to systematically adapt the weekly exercise schedule, which allowed us to monitor and ensure patient adherence to strength and endurance training and optimize the step-wise progressive exercise load. Exercise progression was based on an a priori algorithm that considered the subjective rate for both perceived exhaustion and general physical discomfort. The VO2peak was assessed at baseline and at the end of the study by spiroergometry. Results: A total of 43 patients completed the intervention with no adverse events. The VO2peak increased significantly by 2.4 mL/kg/min (8.8%; 95% confidence interval [CI]: 1.48-3.27; P<.001) accompanied by a reduction of 1.0 kg in a body weight (95% CI: 0.33-1.58; P=.004) and 1.3 kg in body fat mass (95% CI: 0.27-2.27; P=.01). In an exploratory analysis, step-wise logistic regression analysis revealed low body fat and VO2peak at baseline and the total minutes of endurance training during the intervention as main contributors to a positive change in VO2peak. Our predictive model indicated that the average patient with NAFLD needed 223 min for stabilization of VO2peak and 628 min for average improvement in VO2peak. However, in patients with a VO2peak approximately 20% higher than the average VO2peak, 628 min were only sufficient to stabilize the VO2peak and >40% reduction in the average fat mass would be required to achieve an average outcome. Conclusions: This is the first study to show that patients with NAFLD can be effectively supported by a Web-based approach, which can increase the VO2peak to a similar extent as face-to-face interventions. Patients with low body fat and low VO2peak benefited the most from our intervention. In terms of future treatment strategies, NAFLD patients with high body fat may particularly benefit from body-fat reduction through a strict nutritional intervention, subsequently enabling a more effective exercise intervention. Trial Registration: ClinicalTrials.gov NCT02526732; https://clinicaltrials.gov/ct2/show/NCT02526732 (Archived by WebCite at http://www.webcitation.org/74pXhXXfq) International Registered Report Identifier (IRRID): RR2-10.2196/resprot.8607 %M 30602434 %R 10.2196/11250 %U http://www.jmir.org/2019/1/e11250/ %U https://doi.org/10.2196/11250 %U http://www.ncbi.nlm.nih.gov/pubmed/30602434 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 12 %P e11093 %T Digital Weight Loss Intervention for Parents of Children Being Treated for Obesity: A Prospective Cohort Feasibility Trial %A Kay,Melissa C %A Burroughs,Jasmine %A Askew,Sandy %A Bennett,Gary G %A Armstrong,Sarah %A Steinberg,Dori M %+ Duke Global Digital Health Science Center, Duke Center for Childhood Obesity Research, Duke University, 310 Trent Drive, Durham, NC, 27708, United States, 1 781 249 3062, melissa.kay@duke.edu %K obesity %K parent %K child %K digital weight loss intervention %K self-monitoring %K weight %K text %D 2018 %7 20.12.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: The prevalence of childhood obesity continues to increase, and clinic-based treatment options have failed to demonstrate effectiveness. One of the strongest predictors of child weight is parent weight. Parental treatment for weight loss may indirectly reduce obesity in the child. We have previously demonstrated the effectiveness among adults of a fully automated, evidence-based digital weight loss intervention (Track). However, it is unknown if it is feasible to deliver such a treatment directly to parents with obesity who bring their child with obesity to a weight management clinic for treatment. Objective: The objective of our study was to evaluate the feasibility of and engagement with a digital weight loss intervention among parents of children receiving treatment for obesity. Methods: We conducted a 6-month pre-post feasibility trial among parents or guardians and their children aged 4-16 years presenting for tertiary care obesity treatment. Along with the standard family-based treatment protocol, parents received a 6-month digital weight loss intervention, which included weekly monitoring of personalized behavior change goals via mobile technologies. We examined levels of engagement by tracking completed weeks of self-monitoring and feasibility by assessing change in weight. Results: Participants (N=48) were on average 39 years old, mostly female (35/42, 82% ), non-Hispanic Black individuals (21/41, 51%) with obesity (36/48, 75%). Over a quarter had a yearly household income of 60% of the different uses of theory assessed by the TCS were effective on all behavioral and clinical outcomes measured. None of the 11 studies that met ≤60% of the TCS criteria were fully effective; however, 3 interventions were partially effective (ie, the intervention had a significant impact on some, but not all, of the outcomes measured). Most studies lacked detail on the theoretical constructs and how they were applied to the development and application of the intervention. Conclusions: These findings suggest that greater use of theory in the development and application of digital self-management interventions for asthma may increase their effectiveness. The application of theory alone may not be enough to yield a successful intervention, and other factors (eg, the context in which the intervention is used) should be considered. A systematic approach to the use of theory to guide the design, selection, and application of intervention techniques is needed. %M 30541741 %R 10.2196/jmir.9666 %U https://www.jmir.org/2018/12/e293/ %U https://doi.org/10.2196/jmir.9666 %U http://www.ncbi.nlm.nih.gov/pubmed/30541741 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 4 %P e11473 %T A Web-Based Intervention for Relatives of People Experiencing Psychosis or Bipolar Disorder: Design Study Using a User-Centered Approach %A Honary,Mahsa %A Fisher,Naomi Ruth %A McNaney,Roisin %A Lobban,Fiona %+ School of Computing and Communications, Lancaster University, Room C51, InfoLab21, South Drive, Lancaster, LA1 4WA, United Kingdom, 44 1524 593222, m.honary@lancaster.ac.uk %K mental health %K Web-based intervention %K user-centered design %K caregivers %K bipolar disorder %K psychosis %D 2018 %7 07.12.2018 %9 Original Paper %J JMIR Ment Health %G English %X Background: Relatives of people experiencing bipolar mood episodes or psychosis face a multitude of challenges (eg, social isolation, limited coping strategies, and issues with maintaining relationships). Despite this, there is limited informational and emotional support for people who find themselves in supporting or caring roles. Digital technologies provide us with an opportunity to offer accessible tools, which can be used flexibly to provide evidence-based information and support, allowing relatives to build their understanding of mental health problems and learn from others who have similar experiences. However, to design tools that are useful to relatives, we first need to understand their needs. Objective: The aim of this study was to use a user-centered design approach to develop an accessible Web-based intervention, based on the Relatives Education And Coping Toolkit (REACT) booklet, to support the informational and emotional needs of relatives of people experiencing psychosis or bipolar disorder. Methods: We engaged relatives of people with experiences of bipolar disorder or psychosis in workshops to identify their needs and design requirements for developing a Web-based version of a paper-based toolkit. We used a 2-phase qualitative approach to explore relatives’ views on content, design, and functionalities, which are considered to be engaging and useful in a Web-based intervention. In phase 1, we consulted 24 relatives in 2 workshops to better understand their existing support infrastructure, their barriers for accessing support, unmet needs, and relatives’ views on online support. On the basis of the results of these workshops, we developed a set of design considerations to be explored in a smaller workshop. Workshop 3 then involved working with 2 digitally literate relatives to design a usable and acceptable interface for our Web-based toolkit. Finally, in phase 2, we conducted a heuristic evaluation to assess the usability of the toolkit. Results: Our findings indicated that relatives require technologies that (1) they can place their trust in, particularly when discussing a highly sensitive topic, (2) enable learning from the lived experiences of others while retaining confidentiality, and (3) they can work through at their own pace in a personalized manner. Conclusions: Our study highlights the need for providing a trustworthy, supportive tool where relatives can engage with people who have similar experiences to their own. Our heuristic evaluation showed promise in terms of perceived usability of the REACT Web-based intervention. Through this work, we emphasize the need to involve stakeholders with various characteristics, including users with limited computer literacy or experience in online support. %M 30530457 %R 10.2196/11473 %U http://mental.jmir.org/2018/4/e11473/ %U https://doi.org/10.2196/11473 %U http://www.ncbi.nlm.nih.gov/pubmed/30530457 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 12 %P e291 %T Accessibility and Applicability of Currently Available e-Mental Health Programs for Depression for People With Poststroke Aphasia: Scoping Review %A Clunne,Stephanie Jane %A Ryan,Brooke Jade %A Hill,Annie Jane %A Brandenburg,Caitlin %A Kneebone,Ian %+ School of Health and Rehabilitation Sciences, The University of Queensland, 84A Services Road, St Lucia, Brisbane, QLD 4067, Australia, 61 336 51380, brooke.ryan@uq.edu.au %K aphasia %K stroke %K depression %K mental health %K internet %K technology %K access to health care %D 2018 %7 04.12.2018 %9 Review %J J Med Internet Res %G English %X Background: Depression affects approximately 60% of people with aphasia 1 year post stroke and is associated with disability, lower quality of life, and mortality. Web-delivered mental health (e-mental health) programs are effective, convenient, and cost-effective for the general population and thus are increasingly used in the management of depression. However, it is unknown if such services are applicable and communicatively accessible to people with poststroke aphasia. Objective: The aim of this study was to identify freely available e-mental health programs for depression and determine their applicability and accessibility for people with poststroke aphasia. Methods: A Web-based search was conducted to identify and review freely available e-mental health programs for depression. These programs were then evaluated in terms of their (1) general features via a general evaluation tool, (2) communicative accessibility for people with aphasia via an aphasia-specific communicative accessibility evaluation tool, and (3) empirical evidence for the general population and stroke survivors with and without aphasia. The program that met the most general evaluation criteria and aphasia-specific communicative accessibility evaluation criteria was then trialed by a small subgroup of people with poststroke aphasia. Results: A total of 8 programs were identified. Of these, 4 had published evidence in support of their efficacy for use within the general population. However, no empirical evidence was identified that specifically supported any programs’ use for stroke survivors with or without aphasia. One evidence-based program scored at least 80% (16/19 and 16/20, respectively) on both the general and aphasia-specific communicative accessibility evaluation tools and was subject to a preliminary trial by 3 people with poststroke aphasia. During this trial, participants were either unable to independently use the program or gave it low usability scores on a post-trial satisfaction survey. On this basis, further evaluation was considered unwarranted. Conclusions: Despite fulfilling majority of the general evaluation and aphasia-specific evaluation criteria, the highest rated program was still found to be unsuitable for people with poststroke aphasia. Thus, e-mental health programs require substantial redevelopment if they are likely to be useful to people with poststroke aphasia. %M 30514696 %R 10.2196/jmir.9864 %U https://www.jmir.org/2018/12/e291/ %U https://doi.org/10.2196/jmir.9864 %U http://www.ncbi.nlm.nih.gov/pubmed/30514696 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 11 %P e11050 %T A Practical Do-It-Yourself Recruitment Framework for Concurrent eHealth Clinical Trials: Identification of Efficient and Cost-Effective Methods for Decision Making (Part 2) %A Lattie,Emily G %A Kaiser,Susan M %A Alam,Nameyeh %A Tomasino,Kathryn N %A Sargent,Elizabeth %A Rubanovich,Caryn Kseniya %A Palac,Hannah L %A Mohr,David C %+ Center for Behavioral Intervention Technologies, Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 10th Floor, 750 North Lake Shore Drive, Chicago, IL, 60611, United States, 1 3125033741, emily.lattie@northwestern.edu %K eHealth %K mHealth %K mental health %K recruitment %D 2018 %7 29.11.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: The ability to successfully recruit participants for electronic health (eHealth) clinical trials is largely dependent on the use of efficient and effective recruitment strategies. Determining which types of recruitment strategies to use presents a challenge for many researchers. Objective: The aim of this study was to present an analysis of the time-efficiency and cost-effectiveness of recruitment strategies for eHealth clinical trials, and it describes a framework for cost-effective trial recruitment. Methods: Participants were recruited for one of 5 eHealth trials of interventions for common mental health conditions. A multipronged recruitment approach was used, including digital (eg, social media and Craigslist), research registry-based, print (eg, flyers and posters on public transportation), clinic-based (eg, a general internal medicine clinic within an academic medical center and a large nonprofit health care organization), a market research recruitment firm, and traditional media strategies (eg, newspaper and television coverage in response to press releases). The time costs and fees for each recruitment method were calculated, and the participant yield on recruitment costs was calculated by dividing the number of enrolled participants by the total cost for each method. Results: A total of 777 participants were enrolled across all trials. Digital recruitment strategies yielded the largest number of participants across the 5 clinical trials and represented 34.0% (264/777) of the total enrolled participants. Registry-based recruitment strategies were in second place by enrolling 28.0% (217/777) of the total enrolled participants across trials. Research registry-based recruitment had a relatively high conversion rate from potential participants who contacted our center for being screened to be enrolled, and it was also the most cost-effective for enrolling participants in this set of clinical trials with a total cost per person enrolled at US $8.99. Conclusions: On the basis of these results, a framework is proposed for participant recruitment. To make decisions on initiating and maintaining different types of recruitment strategies, the resources available and requirements of the research study (or studies) need to be carefully examined. %M 30497997 %R 10.2196/11050 %U https://www.jmir.org/2018/11/e11050/ %U https://doi.org/10.2196/11050 %U http://www.ncbi.nlm.nih.gov/pubmed/30497997 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 4 %N 4 %P e12397 %T An Online Support Group Intervention for Adolescents Living with HIV in Nigeria: A Pre-Post Test Study %A Dulli,Lisa %A Ridgeway,Kathleen %A Packer,Catherine %A Plourde,Kate F %A Mumuni,Tolulope %A Idaboh,Tosin %A Olumide,Adesola %A Ojengbede,Oladosu %A McCarraher,Donna R %+ Department of Program Sciences and Technical Support, Health Services Research, Family Health International (FHI 360), 359 Blackwell Street, Durham, NC, 27701, United States, 1 919 544 7040, ldulli@fhi360.org %K adolescents %K digital health intervention %K HIV care continuum %K social support %D 2018 %7 28.11.2018 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: Adolescents living with HIV (ALHIVs) enrolled in HIV treatment services experience greater loss to follow-up and suboptimal adherence than other age groups. HIV-related stigma, disclosure-related issues, lack of social support, and limited HIV knowledge impede adherence to antiretroviral therapy (ART) and retention in HIV services. The 90-90-90 goals for ALHIVs will only be met through strategies targeted to meet their specific needs. Objectives: We aimed to evaluate the feasibility of implementing a social media-based intervention to improve HIV knowledge, social support, ART adherence, and retention among ALHIV aged 15-19 years on ART in Nigeria. Methods: We conducted a single-group pre-post test study from June 2017 to January 2018. We adapted an existing support group curriculum and delivered it through trained facilitators in 5 support groups by using Facebook groups. This pilot intervention included five 1-week sessions. We conducted structured interviews with participants before and after the intervention, extracted clinical data, and documented intervention implementation and participation. In-depth interviews were conducted with a subset of participants at study completion. Quantitative data from structured interviews and group participation data were summarized descriptively, and qualitative data were coded and summarized. Results: A total of 41 ALHIV enrolled in the study. At baseline, 93% of participants reported existing phone access; 65% used the internet, and 64% were Facebook users. In addition, 37 participants completed the 5-session intervention, 32 actively posted comments in at least one session online, and at least half commented in each of the 5 sessions. Facilitators delivered most sessions as intended and on-time. Participants were enthusiastic about the intervention. Aspects of the intervention liked most by participants included interacting with other ALHIVs; learning about HIV; and sharing questions, experiences, and fears. The key recommendations were to include larger support groups and encourage more group interaction. Specific recommendations on various intervention components were made to improve the intervention. Conclusions: This novel intervention was feasible to implement in a predominantly suburban and rural Nigerian setting. Social media may be leveraged to provide much-needed information and social support on platforms accessible and familiar to many people, even in resource-constrained communities. Our findings have been incorporated into the intervention, and an outcome study is underway. Trial Registration: ClinicalTrials.gov NCT03076996; https://clinicaltrials.gov/ct2/show/NCT03076996 (Archived by WebCite at http://www.webcitation.org/73oCCEBBC). %M 30487116 %R 10.2196/12397 %U http://publichealth.jmir.org/2018/4/e12397/ %U https://doi.org/10.2196/12397 %U http://www.ncbi.nlm.nih.gov/pubmed/30487116 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 11 %P e10927 %T Guided Internet-Based Cognitive Behavioral Therapy for Adult Depression and Anxiety in Routine Secondary Care: Observational Study %A Mathiasen,Kim %A Riper,Heleen %A Andersen,Tonny E %A Roessler,Kirsten K %+ Department of Psychology, Faculty of Health Sciences, University of Southern Denmark, Campusvej 55, Odense, 5230, Denmark, 45 61677747, kim.mathiasen@rsyd.dk %K anxiety %K cognitive therapy %K cohort studies %K depression %K Internet %K secondary care %D 2018 %7 28.11.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-based cognitive behavioral therapy (iCBT) is a promising new treatment method for depression and anxiety. However, it is important to determine whether its results can be replicated in routine care before its implementation on a large scale. Although many studies have demonstrated the efficacy of iCBT under controlled conditions, only a few studies have investigated its effectiveness in routine care. Furthermore, several effects of iCBT such as treatment effects in routine care are unclear. Objective: This study aimed to evaluate the clinical effectiveness of iCBT for depression and anxiety in routine secondary care. Methods: n a retrospective cohort study, we analysed patients treated for depression or anxiety in a dedicated iCBT clinic in secondary care in Denmark. Patients were examined before treatment and weekly thereafter by using the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder-7 scales for the diagnoses of depression and anxiety, respectively. Primary analyses were conducted using a linear mixed-effects model with random slope and intercept. Secondary analyses were conducted using baseline characteristics as predictors (gender, age, highest level of education, occupational status, marital status, psychotropic medication use, consumption of alcohol, and leisure drugs). Additionally, logistic regression analyses were used to predict noncompletion of treatment. Results: A total of 203 (depression, N=60; anxiety, N=143) patients were included. Participants were mainly female (78.3% with depression and 65.7% with anxiety), with a mean age of 36.03 (SD 10.97) years (range, 19-67 years) for patients with depression and 36.80 (SD 13.55) years (range, 19-69 years) for patients with anxiety. The completion rates were 62% (37) and 40% (57) for depression and anxiety treatments, respectively. The primary analyses revealed large and significant reductions in the symptom levels of depression (beta=-6.27, SE 0.83, P<.001, d=1.0) and anxiety (beta=-3.78, SE 0.43, P<.001, d=1.1). High baseline severity of the primary disorder was associated with high treatment gains (r=-0.31 for depression; r=-0.41 for anxiety). In patients with anxiety, high baseline severity also predicted a high risk of noncompletion (odds ratio=1.08, CI=1.01-1.16, P=.03). An increase in the baseline severity of the comorbid disorder slightly increased the risk of noncompletion for both disorders (depression: odds ratio=1.03, CI=1.01-1.06, P=.02; anxiety: odds ratio=1.08, CI=1.01-1.16, P=.03). Conclusions: iCBT can be clinically effective in routine care. Since depression and anxiety are costly and debilitating disorders that are vastly undertreated, this finding is important. Additionally, iCBT may help bridge the gap between the need for treatment and its provision. Our results are comparable to the within-group results of efficacy and effectiveness studies. Our noncompletion rates are similar to those observed in psychotherapy but are higher than those reported in similar clinics. Multiple factors predicted outcome and noncompletion. However, all predictor effects were statistically weak. %M 30487118 %R 10.2196/10927 %U http://www.jmir.org/2018/11/e10927/ %U https://doi.org/10.2196/10927 %U http://www.ncbi.nlm.nih.gov/pubmed/30487118 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 11 %P e11602 %T A Web-Based Telemanagement System for Improving Disease Activity and Quality of Life in Patients With Complex Inflammatory Bowel Disease: Pilot Randomized Controlled Trial %A Del Hoyo,Javier %A Nos,Pilar %A Faubel,Raquel %A Muñoz,Diana %A Domínguez,David %A Bastida,Guillermo %A Valdivieso,Bernardo %A Correcher,Marisa %A Aguas,Mariam %+ Gastroenterology Department, La Fe University and Polytechnic Hospital, Av Fernando Abril Martorell 106, Valencia, 46026, Spain, 34 600859948, m.aguas.peris@gmail.com %K Crohn disease %K e-health %K inflammatory bowel disease %K information and communication technology %K telemedicine %K ulcerative colitis %D 2018 %7 27.11.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: The reported efficacy of telemedicine in patients with inflammatory bowel disease (IBD) is inconsistent among studies, and data for complex IBD are lacking. Objective: We aimed to evaluate the impact of remote monitoring using a Web system—Telemonitorización de la Enfermedad de Crohn y Colitis Ulcerosa or Telemonitoring of Crohn’s Disease and Ulcerative Colitis (TECCU)—as compared to standard care and telephone care on health outcomes and health care in patients with complex IBD. Methods: We performed a 3-arm randomized controlled trial. Adult patients with IBD who received immunosuppressants and biological agents were recruited from the IBD Unit of a tertiary university hospital. The patients were randomized into groups to receive remote monitoring (G_TECCU), nurse-assisted telephone care (G_NT), or standard care with in-person visits (G_control). All patients completed the study visits at baseline and at 12 and 24 weeks in addition to each type of intervention. The primary outcome was the percentage of patients in remission at 24 weeks. Secondary health outcomes were quality of life, medication adherence, adverse effects, satisfaction, and social activities. Data on the number of outpatient visits and telephone calls, emergency visits, hospitalizations, IBD-related surgeries, and corticosteroid courses were also collected. Results: A total of 63 patients were selected (21 patients in each group). During the study, 90.5% (19/21) of patients in G_control, 95.2% (20/21) in G_NT, and 85.7% (18/21) in G_TECCU were compliant to the intervention. After 24 weeks, the percentage of patients in remission was higher in G_TECCU (17/21, 81%) than in G_NT (14/21, 66.7%) and G_control (15/21, 71.4%). A higher improvement in disease activity was observed in G_TECCU than in G_control in terms of the Harvey-Bradshaw/Mayo (odds ratio=0.12, 95% CI=0.003-2.162, P=.19) and Harvey-Bradshaw/Walmsley (odds ratio=0.11, 95% CI=0.004-1.55, P=.13) indexes. Improvement in disease activity was associated with a larger reduction in fecal calprotectin values in G_TECCU compared to G_control (estimated intervention effect: odds ratio=–0.90; 95% CI=–1.96 to 0.16, P=.11). All completers adhered to treatment in G_TECCU. In addition, the quality of life, social activities, and satisfaction improved in all 3 groups. Although the number of outpatient visits and telephone calls was lower in G_TECCU than in G_NT and G_control, the safety profile was similar in all 3 groups. Conclusions: This pilot clinical trial suggests that the TECCU Web-based system is a safe strategy for improving health outcomes in patients with complex IBD and reducing the use of health care resources. Trial Registration: ClinicalTrials.gov NCT02943538; https://clinicaltrials.gov/ct2/show/NCT02943538 (Archived by WebCite at http://www.webcitation.org/746CRRtDN). %M 30482739 %R 10.2196/11602 %U http://www.jmir.org/2018/11/e11602/ %U https://doi.org/10.2196/11602 %U http://www.ncbi.nlm.nih.gov/pubmed/30482739 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 11 %P e10971 %T Evidence-Based Evaluation of eHealth Interventions: Systematic Literature Review %A Enam,Amia %A Torres-Bonilla,Johanna %A Eriksson,Henrik %+ Centre for Healthcare Improvement, Technology Management and Economics, Chalmers University of Technology, Vera Sandbergs Alle 8, Gothenburg, 412 96, Sweden, 46 8609449850, amiaenam@gmail.com %K evidence-based practice %K program evaluation %K systematic review %K technology assessment %D 2018 %7 23.11.2018 %9 Review %J J Med Internet Res %G English %X Background: Until now, the use of technology in health care was driven mostly by the assumptions about the benefits of electronic health (eHealth) rather than its evidence. It is noticeable that the magnitude of evidence of effectiveness and efficiency of eHealth is not proportionate to the number of interventions that are regularly conducted. Reliable evidence generated through comprehensive evaluation of eHealth interventions may accelerate the growth of eHealth for long-term successful implementation and help to experience eHealth benefits in an enhanced way. Objective: This study aimed to understand how the evidence of effectiveness and efficiency of eHealth can be generated through evaluation. Hence, we aim to discern (1) how evaluation is conducted in distinct eHealth intervention phases, (2) the aspects of effectiveness and efficiency that are typically evaluated during eHealth interventions, and (3) how eHealth interventions are evaluated in practice. Methods: A systematic literature review was conducted to explore the evaluation methods for eHealth interventions. Preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines were followed. We searched Google Scholar and Scopus for the published papers that addressed the evaluation of eHealth or described an eHealth intervention study. A qualitative analysis of the selected papers was conducted in several steps. Results: We intended to see how the process of evaluation unfolds in distinct phases of an eHealth intervention. We revealed that in practice and in several conceptual papers, evaluation is performed at the end of the intervention. There are some studies that discuss the importance of conducting evaluation throughout the intervention; however, in practice, we found no case study that followed this. For our second research question, we discovered aspects of efficiency and effectiveness that are proposed to be assessed during interventions. The aspects that were recurrent in the conceptual papers include clinical, human and social, organizational, technological, cost, ethical and legal, and transferability. However, the case studies reviewed only evaluate the clinical and human and social aspects. At the end of the paper, we discussed a novel approach to look into the evaluation. Our intention was to stir up a discussion around this approach with the hope that it might be able to gather evidence in a comprehensive and credible way. Conclusions: The importance of evidence in eHealth has not been discussed as rigorously as have the diverse evaluation approaches and evaluation frameworks. Further research directed toward evidence-based evaluation can not only improve the quality of intervention studies but also facilitate successful long-term implementation of eHealth in general. We conclude that the development of more robust and comprehensive evaluation of eHealth studies or an improved validation of evaluation methods could ease the transferability of results among similar studies. Thus, the resources can be used for supplementary research in eHealth. %M 30470678 %R 10.2196/10971 %U http://www.jmir.org/2018/11/e10971/ %U https://doi.org/10.2196/10971 %U http://www.ncbi.nlm.nih.gov/pubmed/30470678 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 11 %P e12052 %T Evaluation of a Web-Based Intervention for Multiple Health Behavior Changes in Patients With Coronary Heart Disease in Home-Based Rehabilitation: Pilot Randomized Controlled Trial %A Duan,Yan Ping %A Liang,Wei %A Guo,Lan %A Wienert,Julian %A Si,Gang Yan %A Lippke,Sonia %+ Department of Sport and Physical Education, Faculty of Social Sciences, Hong Kong Baptist University, 12/F, Shek Mun Campus, 8 On Muk Street, Shek Mun, Shatin, Hong Kong,, China (Hong Kong), 852 3411 3080, duanyp@hkbu.edu.hk %K eHealth %K physical activity %K diet %K cardiac rehabilitation %K health resources %D 2018 %7 19.11.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based and theory-based interventions for multiple health behaviors appears to be a promising approach with respect to the adoption and maintenance of a healthy lifestyle in cardiac patients who have been discharged from the hospital. Until now, no randomized controlled trials have tested this assumption among Chinese rehabilitation patients with coronary heart disease using a Web-based intervention. Objective: The study aim was to evaluate the effect of an 8-week Web-based intervention in terms of physical activity (PA), fruit and vegetable consumption (FVC), lifestyle changes, social-cognitive outcomes, and health outcomes compared with a waiting control group in Chinese cardiac patients. The intervention content was theory-based on the health action process approach. Self-reported data were evaluated, including PA, FVC, healthy lifestyle (the synthesis of PA and FVC), internal resources (combination of intention, self-efficacy, and planning), and an external resource (social support) of PA and FVC behaviors, as well as perceived health outcomes (body mass index, quality of life, and depression). Methods: In a randomized controlled trial, 136 outpatients with coronary heart disease from the cardiac rehabilitation center of a hospital in China were recruited. After randomization and exclusion of unsuitable participants, 114 patients were assigned to 1 of the 2 groups: (1) the intervention group: first 4 weeks on PA and subsequent 4 weeks on FVC and (2) the waiting control group. A total of 2 Web-based assessments were conducted, including 1 at the beginning of the intervention (T1, N=114), and 1 at the end of the 8-week intervention (T2, N=83). The enrollment and follow-up took place from December 2015 to May 2016. Results: The Web-based intervention outperformed the control condition for PA, FVC, internal resources of PA and FVC, and an external resource of FVC, with an eta-squared effect size ranging from 0.06 to 0.43. Furthermore, the intervention effect was seen in the improvement of quality of life (F1,79=16.36, P<.001, η2=.17). When predicting a healthy lifestyle at follow-up, baseline lifestyle (odds ratio, OR 145.60, 95% CI 11.24-1886; P<.001) and the intervention (OR 21.32, 95% CI 2.40-189.20; P=.006) were found to be significant predictors. Internal resources for FVC mediated the effect of the intervention on the adoption of a healthy lifestyle (R2adj=.29; P=.001), indicating that if the intervention increased the internal resource of behavior, the adoption of a healthy lifestyle was more likely. Conclusions: Patients’ psychological resources such as motivation, self-efficacy, planning, and social support as well as lifestyle can be improved by a Web-based intervention that focuses on both PA and FVC. Such an intervention enriches extended rehabilitation approaches for cardiac patients to be active and remain healthy in daily life after hospital discharge. Trial Registration: ClinicalTrials.gov NCT01909349; https://clinicaltrials.gov/ct2/show/NCT01909349 (Archived by WebCite at http://www.webcitation.org/6pHV1A0G1) %M 30455167 %R 10.2196/12052 %U http://www.jmir.org/2018/11/e12052/ %U https://doi.org/10.2196/12052 %U http://www.ncbi.nlm.nih.gov/pubmed/30455167 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 11 %P e292 %T Measuring Engagement in eHealth and mHealth Behavior Change Interventions: Viewpoint of Methodologies %A Short,Camille E %A DeSmet,Ann %A Woods,Catherine %A Williams,Susan L %A Maher,Carol %A Middelweerd,Anouk %A Müller,Andre Matthias %A Wark,Petra A %A Vandelanotte,Corneel %A Poppe,Louise %A Hingle,Melanie D %A Crutzen,Rik %+ Freemasons Foundation Centre for Men's Health, School of Medicine, University of Adelaide, Level 7, South Australian Health and Medical Research Institute, North Terrace, Adelaide, 5000, Australia, 61 61883130532, camille.short@adelaide.edu.au %K telemedicine %K internet %K health promotion %K evaluation studies %K treatment adherence and compliance %K outcome and process assessment (health care) %D 2018 %7 16.11.2018 %9 Viewpoint %J J Med Internet Res %G English %X Engagement in electronic health (eHealth) and mobile health (mHealth) behavior change interventions is thought to be important for intervention effectiveness, though what constitutes engagement and how it enhances efficacy has been somewhat unclear in the literature. Recently published detailed definitions and conceptual models of engagement have helped to build consensus around a definition of engagement and improve our understanding of how engagement may influence effectiveness. This work has helped to establish a clearer research agenda. However, to test the hypotheses generated by the conceptual modules, we need to know how to measure engagement in a valid and reliable way. The aim of this viewpoint is to provide an overview of engagement measurement options that can be employed in eHealth and mHealth behavior change intervention evaluations, discuss methodological considerations, and provide direction for future research. To identify measures, we used snowball sampling, starting from systematic reviews of engagement research as well as those utilized in studies known to the authors. A wide range of methods to measure engagement were identified, including qualitative measures, self-report questionnaires, ecological momentary assessments, system usage data, sensor data, social media data, and psychophysiological measures. Each measurement method is appraised and examples are provided to illustrate possible use in eHealth and mHealth behavior change research. Recommendations for future research are provided, based on the limitations of current methods and the heavy reliance on system usage data as the sole assessment of engagement. The validation and adoption of a wider range of engagement measurements and their thoughtful application to the study of engagement are encouraged. %M 30446482 %R 10.2196/jmir.9397 %U http://www.jmir.org/2018/11/e292/ %U https://doi.org/10.2196/jmir.9397 %U http://www.ncbi.nlm.nih.gov/pubmed/30446482 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 11 %P e280 %T Internet-Delivered Early Interventions for Individuals Exposed to Traumatic Events: Systematic Review %A Ennis,Naomi %A Sijercic,Iris %A Monson,Candice M %+ Department of Psychology, Ryerson University, 350 Victoria Street, Toronto, ON, M5B 2K3, Canada, 1 4169795000 ext 6209, candice.monson@psych.ryerson.ca %K psychological trauma %K secondary prevention %K trauma and stressor-related disorders %K internet %D 2018 %7 14.11.2018 %9 Review %J J Med Internet Res %G English %X Background: Over 75% of individuals are exposed to a traumatic event, and a substantial minority goes on to experience mental health problems that can be chronic and pernicious in their lifetime. Early interventions show promise for preventing trauma following psychopathology; however, a face-to-face intervention can be costly, and there are many barriers to accessing this format of care. Objective: The aim of this study was to systematically review studies of internet-delivered early interventions for trauma-exposed individuals. Methods: A literature search was conducted in PsycINFO and PubMed for papers published between 1991 and 2017. Papers were included if the following criteria were met: (1) an internet-based intervention was described and applied to individuals exposed to a traumatic event; (2) the authors stated that the intervention was intended to be applied early following trauma exposure or as a preventive intervention; and (3) data on mental health symptoms at pre-and postintervention were described (regardless of whether these were primary outcomes). Methodological quality of included studies was assessed using the Downs and Black checklist. Results: The interventions in the 7 studies identified were categorized as selected (ie, delivered to an entire sample after trauma regardless of psychopathology symptoms) or indicated (ie, delivered to those endorsing some level of posttraumatic distress). Selected interventions did not produce significant symptom improvement compared with treatment-as-usual or no intervention control groups. However, indicated interventions yielded significant improvements over other active control conditions on mental health outcomes. Conclusions: Consistent with the notion that many experience natural recovery following trauma, results imply that indicated early internet-delivered interventions hold the most promise in future prevention efforts. More studies that use rigorous methods and clearly defined outcomes are needed to evaluate the efficacy of early internet-delivered interventions. Moreover, basic research on risk and resilience factors following trauma exposure is necessary to inform indicated internet-delivered interventions. %M 30429113 %R 10.2196/jmir.9795 %U https://www.jmir.org/2018/11/e280/ %U https://doi.org/10.2196/jmir.9795 %U http://www.ncbi.nlm.nih.gov/pubmed/30429113 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 11 %P e10114 %T Using Mobile Phones to Examine and Enhance Perceptions of Control in Mildly Depressed and Nondepressed Volunteers: Intervention Study %A Msetfi,Rachel %A O'Sullivan,Donal %A Walsh,Amy %A Nelson,John %A Van de Ven,Pepijn %+ Department of Psychology, Health Research Institute, University of Limerick, Castletroy, Limerick,, Ireland, 353 61202709, rachel.msetfi@ul.ie %K perception of control %K illusory control %K well-being %K depression %K health %K intervention %K causal learning %D 2018 %7 09.11.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Perceived control is strongly linked to healthy outcomes, mental healthiness, and psychological well-being. This is particularly important when people have little control over things that are happening to them. Perceived control studies have been performed extensively in laboratory settings and show that perceived control can be increased by experimental manipulations. Although these studies suggest that it may be possible to improve people’s mental health by increasing their perceived control, there is very little evidence to date to suggest that perceived control can also be influenced in the real world. Objective: The first aim of this study was to test for evidence of a link between noncontrol situations and psychological well-being in the real world using a mobile phone app. The second and arguably more important aim of the study was to test whether a simple instructional intervention on the nature of alternative causes would enhance people’s perceptions of their own control in these noncontrol situations. Methods: We implemented a behavioral action-outcome contingency judgment task using a mobile phone app. An opportunity sample of 106 healthy volunteers scoring low (n=56, no depression) or high (n=50, mild depression) on a depression scale participated. They were given no control over the occurrence of a low- or high-frequency stimulus that was embedded in everyday phone interactions during a typical day lasting 8 hours. The intervention involved instructions that either described a consistent alternative cause against which to assess their own control, or dynamic alternative causes of the outcome. Throughout the day, participants rated their own control over the stimulus using a quantitative judgment scale. Results: Participants with no evidence of depression overestimated their control, whereas those who were most depressed were more accurate in their control ratings. Instructions given to all participants about the nature of alternative causes significantly affected the pattern of perceived control ratings. Instructions describing discrete alternative causes enhanced perceived control for all participants, whereas dynamic alternative causes were linked to less perceived control. Conclusions: Perceptions of external causes are important to perceived control and can be used to enhance people’s perceptions. Theoretically motivated interventions can be used to enhance perceived control using mobile phone apps. This is the first study to do so in a real-world setting. %M 30413398 %R 10.2196/10114 %U http://mhealth.jmir.org/2018/11/e10114/ %U https://doi.org/10.2196/10114 %U http://www.ncbi.nlm.nih.gov/pubmed/30413398 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 11 %P e10226 %T Implementation Tells Us More Beyond Pooled Estimates: Secondary Analysis of a Multicountry mHealth Trial to Reduce Blood Pressure %A Carrillo-Larco,Rodrigo M %A Jiwani,Safia S %A Diez-Canseco,Francisco %A Kanter,Rebecca %A Beratarrechea,Andrea %A Irazola,Vilma %A Ramirez-Zea,Manuel %A Rubinstein,Adolfo %A Martinez,Homero %A Miranda,J Jaime %A , %+ INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama, Calzada Roosevelt 6-25 Zona 11, Guatemala, Apartado Postal 1188, Guatemala, 502 2472 3762, mramirez@incap.int %K Argentina %K behavior %K clinical trial %K Guatemala %K health risk behaviors, lifestyle risk reduction %K mHealth %K Peru %D 2018 %7 01.11.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The uptake of an intervention aimed at improving health-related lifestyles may be influenced by the participant’s stage of readiness to change behaviors. Objective: We conducted secondary analysis of the Grupo de Investigación en Salud Móvil en América Latina (GISMAL) trial according to levels of uptake of intervention (dose-response) to explore outcomes by country, in order to verify the consistency of the trial’s pooled results, and by each participant’s stage of readiness to change a given lifestyle at baseline. The rationale for this secondary analysis is motivated by the original design of the GISMAL study that was independently powered for the primary outcome—blood pressure—for each country. Methods: We conducted a secondary analysis of a mobile health (mHealth) multicountry trial conducted in Argentina, Guatemala, and Peru. The intervention consisted of monthly motivational phone calls by a trained nutritionist and weekly tailored text messages (short message service), over a 12-month period, aimed to enact change on 4 health-related behaviors: salt added to foods when cooking, consumption of high-fat and high-sugar foods, consumption of fruits or vegetables, and practice of physical activity. Results were stratified by country and by participants’ stage of readiness to change (precontemplation or contemplation; preparation or action; or maintenance) at baseline. Exposure (intervention uptake) was the level of intervention (<50%, 50%-74%, and ≥75%) received by the participant in terms of phone calls. Linear regressions were performed to model the outcomes of interest, presented as standardized mean values of the following: blood pressure, body weight, body mass index, waist circumference, physical activity, and the 4 health-related behaviors. Results: For each outcome of interest, considering the intervention uptake, the magnitude and direction of the intervention effect differed by country and by participants’ stage of readiness to change at baseline. Among those in the high intervention uptake category, reductions in systolic blood pressure were only achieved in Peru, whereas fruit and vegetable consumption also showed reductions among those who were at the maintenance stage at baseline in Argentina and Guatemala. Conclusions: Designing interventions oriented toward improving health-related lifestyle behaviors may benefit from recognizing baseline readiness to change and issues in implementation uptake. Trial Registration: ClinicalTrials.gov NCT01295216; http://clinicaltrials.gov/ct2/show/NCT01295216 (Archived by WebCite at http://www.webcitation.org/72tMF0B7B). %M 30389646 %R 10.2196/10226 %U http://mhealth.jmir.org/2018/11/e10226/ %U https://doi.org/10.2196/10226 %U http://www.ncbi.nlm.nih.gov/pubmed/30389646 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 11 %P e11049 %T A Practical Do-It-Yourself Recruitment Framework for Concurrent eHealth Clinical Trials: Simple Architecture (Part 1) %A Palac,Hannah L %A Alam,Nameyeh %A Kaiser,Susan M %A Ciolino,Jody D %A Lattie,Emily G %A Mohr,David C %+ Center for Behavioral Intervention Technologies, Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 10th Floor, 750 North Lake Shore Drive, Chicago, IL, 60611, United States, 1 3125033741, emily.lattie@northwestern.edu %K eHealth %K mHealth %K online recruitment %K REDCap %K referral management %D 2018 %7 01.11.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: The ability to identify, screen, and enroll potential research participants in an efficient and timely manner is crucial to the success of clinical trials. In the age of the internet, researchers can be confronted with large numbers of people contacting the program, overwhelming study staff and frustrating potential participants. Objective: This paper describes a “do-it-yourself” recruitment support framework (DIY-RSF) that uses tools readily available in many academic research settings to support remote participant recruitment, prescreening, enrollment, and management across multiple concurrent eHealth clinical trials. Methods: This work was conducted in an academic research center focused on developing and evaluating behavioral intervention technologies. A needs assessment consisting of unstructured individual and group interviews was conducted to identify barriers to recruitment and important features for the new system. Results: We describe a practical and adaptable recruitment management architecture that used readily available software, such as REDCap (Research Electronic Data Capture) and standard statistical software (eg, SAS, R), to create an automated recruitment framework that supported prescreening potential participants, consent to join a research registry, triaging for management of multiple trials, capture of eligibility information for each phase of a recruitment pipeline, and staff management tools including monitoring of participant flow and task assignment/reassignment features. The DIY-RSF was launched in July 2015. As of July 2017, the DIY-RSF has supported the successful recruitment efforts for eight trials, producing 14,557 participant records in the referral tracking database and 5337 participants in the center research registry. The DIY-RSF has allowed for more efficient use of staff time and more rapid processing of potential applicants. Conclusions: Using tools already supported at many academic institutions, we describe the architecture and utilization of an adaptable referral management framework to support recruitment for multiple concurrent clinical trials. The DIY-RSF can serve as a guide for leveraging common technologies to improve clinical trial recruitment procedures. %M 30389650 %R 10.2196/11049 %U https://www.jmir.org/2018/11/e11049/ %U https://doi.org/10.2196/11049 %U http://www.ncbi.nlm.nih.gov/pubmed/30389650 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 10 %P e10158 %T Web-Based Health Intervention for Young People Who Have a Parent with a Mental Illness: Delphi Study Among Potential Future Users %A Matar,Jodie L %A Maybery,Darryl J %A McLean,Louise A %A Reupert,Andrea %+ Education, Psychology Programs, Monash University, 19 Ancora Imparo Way, Clayton, 3800, Australia, 61 399024587, andrea.reupert@monash.edu %K Delphi studies %K early medical intervention %K internet %K preventative health %K Web-based intervention %K youth %D 2018 %7 31.10.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Young people who have a parent with a mental illness face elevated risks to their mental health and well-being. However, they may not have access to appropriate interventions. Web-based interventions may reach and meet the needs of this at-risk group, yet their preferences regarding the features of this medium are unknown. Objective: This study sought to determine the utility of a Web-based intervention to meet the needs of young people who have a parent with a mental illness and their perspectives regarding the types of features of such a website. Methods: A systematic, 2-round Delphi study was employed to solicit the views of 282 young people aged 16 to 21 years (Round 1, n=14; Round 2, n=268) from urban and regional settings in Australia who self-reported that their parent has a mental illness. “Regional” was used to refer to nonurban participants in the study. After ascertaining whether a Web-based intervention was warranted, Web-based intervention features were identified, including how the site might be facilitated, topics, duration and frequency, and the nature of the professional contact. The extent to which young people agreed on the importance of these factors was assessed. Differences and similarities across gender and location were investigated. A mixed method analytic framework was employed using thematic analysis as well as 2-way between-groups analysis of covariance (ANCOVA) controlling for age and chi-square test of independence analysis. Results: Both rounds highlighted a strong preference for a Web-based intervention. Consensus was reached for a professionally monitored site, young people and professionals having equal input into the weekly facilitated sessions (eg, sharing the lead role in discussions or deciding on relevant session content), unlimited time access, 1-hour, open discussion, weekly sessions over 6 weeks, psychoeducation about mental illness, and considerations for the management of safety violations. There were significant main effects of location type and several of the preferred features for a Web-based intervention for young people who have a parent with a mental illness. However, effect sizes were small to moderate, limiting practical application. Conclusions: Young people aged 16 to 21 years indicated a need for a professionally monitored, psychoeducational, Web-based intervention, with input from professional facilitators and other young people who have a parent with a mental illness, in addition to recommendations to external resources. These findings may inform the development of future Web-based interventions for this highly vulnerable group. %M 30381281 %R 10.2196/10158 %U http://www.jmir.org/2018/10/e10158/ %U https://doi.org/10.2196/10158 %U http://www.ncbi.nlm.nih.gov/pubmed/30381281 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 2 %N 2 %P e10183 %T Multidisciplinary Smartphone-Based Interventions to Empower Patients With Acute Coronary Syndromes: Qualitative Study on Health Care Providers’ Perspectives %A Bashi,Nazli %A Hassanzadeh,Hamed %A Varnfield,Marlien %A Wee,Yong %A Walters,Darren %A Karunanithi,Mohanraj %+ Australian e-Health Research Centre, Level 5 - UQ Health Sciences Building 901/16, Royal Brisbane and Women's Hospital, Herston, 4029, Australia, 61 7 3253 3611, nazli.bashi@csiro.au %K acute coronary syndrome %K focus group %K health care professionals %K mobile phone %K multidisciplinary %K thematic analysis %D 2018 %7 31.10.2018 %9 Original Paper %J JMIR Cardio %G English %X Background: Postdischarge interventions are limited in patients with acute coronary syndrome (ACS) due to few scheduled visits to outpatient clinics and travel from remote areas. Smartphones have become a viable lifestyle technology to deliver educational and health interventions following discharge from hospital. Objective: The purpose of this study was to identify the requirements for the delivery of a mobile health intervention for the postdischarge management of patients with ACS via a multidisciplinary focus group. Methods: We conducted a focus group among health care professionals (n=10) from a large metropolitan hospital in May 2017. These participants from a multidisciplinary team contributed to a 1-hour discussion by responding to 8 questions relating to the applicability of smartphone-based educational and health interventions. Descriptive statistics of the focus group data were analyzed using SPSS. The qualitative data were analyzed according to relevant themes extracted from the focus group transcription, using a qualitative description software program (NVivo 11) and an ontology-based concept mapping approach. Results: The mean age of the participants was 47 (SD 8) years: 3 cardiologists; 2 nurse practitioners; 2 clinical nurses; 2 research scientists; and 1 physiotherapist. Of these participants, 70% (7/10) had experience using electronic health intervention during their professional practice. A total of 7 major themes and their subthemes emerged from the qualitative analysis. Health care providers indicated that comprehensive education on diet, particularly providing daily meal plans, is critical for patients with ACS. In terms of ACS symptoms, a strong recommendation was to focus on educating patients instead of daily monitoring of chest pain and shortness of breathing due to subjectivity and insufficient information for clinicians. Participants pointed that monitoring health measures such as blood pressure and body weight may result in increased awareness of patient physical health, yet may not be sufficient to support patients with ACS via the smartphone-based intervention. Therefore, monitoring pain and emotional status along with other health measures was recommended. Real-time support via FaceTime or video conferencing was indicated as motivational and supportive for patient engagement and self-monitoring. The general demographics of patients with ACS being older, having a low educational level, and a lack of computer skills were identified as potential barriers for engagement with the smartphone-based intervention. Conclusions: A smartphone-based program that incorporates the identified educational materials and health interventions would motivate patients with ACS to engage in the multidisciplinary intervention and improve their health outcomes following discharge from hospital. %M 31758781 %R 10.2196/10183 %U http://cardio.jmir.org/2018/2/e10183/ %U https://doi.org/10.2196/10183 %U http://www.ncbi.nlm.nih.gov/pubmed/31758781 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 10 %P e284 %T Barriers and Facilitators When Implementing Web-Based Disease Monitoring and Management as a Substitution for Regular Outpatient Care in Pediatric Asthma: Qualitative Survey Study %A van den Wijngaart,Lara S %A Geense,Wytske W %A Boehmer,Annemie LM %A Brouwer,Marianne L %A Hugen,Cindy AC %A van Ewijk,Bart E %A Koenen-Jacobs,Marie-José %A Landstra,Anneke M %A Niers,Laetitia EM %A van Onzenoort-Bokken,Lonneke %A Ottink,Mark D %A Rikkers-Mutsaerts,Eleonora RVM %A Groothuis,Iris %A Vaessen-Verberne,Anja A %A Roukema,Jolt %A Merkus,Peter JFM %+ Department of Pediatric Pulmonology, Amalia Children's Hospital, Radboud Institute of Health Sciences, Radboud University Medical Center, Geert Grooteplein 10, Nijmegen, 6500 HB, Netherlands, 31 2414430, lara.vandenwijngaart@radboudumc.nl %K asthma %K barriers and facilitators %K eHealth %K pediatric %K Web-based monitoring %D 2018 %7 30.10.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite their potential benefits, many electronic health (eHealth) innovations evaluated in major studies fail to integrate into organizational routines, and the implementation of these innovations remains problematic. Objective: The purpose of this study was to describe health care professionals’ self-identified perceived barriers and facilitators for the implementation of a Web-based portal to monitor asthmatic children as a substitution for routine outpatient care. Also, we assessed patients’ (or their parents) satisfaction with this eHealth innovation. Methods: Between April and November 2015, we recruited 76 health care professionals (from 14 hospitals). During a period of 6 months, participants received 3 questionnaires to identify factors that facilitated or impeded the use of this eHealth innovation. Questionnaires for patients (or parents) were completed after the 6-month virtual asthma clinic (VAC) implementation period. Results: Major perceived barriers included concerns about the lack of structural financial reimbursement for Web-based monitoring, lack of integration of this eHealth innovation with electronic medical records, the burden of Web-based portal use on clinician workload, and altered patient-professional relationship (due to fewer face-to-face contacts). Major perceived facilitators included enthusiastic and active initiators, a positive attitude of professionals toward eHealth, the possibility to tailor care to individual patients (“personalized eHealth”), easily deliverable care according to current guidelines using the VAC, and long-term profit and efficiency. Conclusions: The implementation of Web-based disease monitoring and management in children is complex and dynamic and is influenced by multiple factors at the levels of the innovation itself, individual professionals, patients, social context, organizational context, and economic and political context. Understanding and defining the barriers and facilitators that influence the context is crucial for the successful implementation and sustainability of eHealth innovations. %M 30377147 %R 10.2196/jmir.9245 %U http://www.jmir.org/2018/10/e284/ %U https://doi.org/10.2196/jmir.9245 %U http://www.ncbi.nlm.nih.gov/pubmed/30377147 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 10 %P e11247 %T Caregiver-Focused, Web-Based Interventions: Systematic Review and Meta-Analysis (Part 2) %A Ploeg,Jenny %A Ali,Muhammad Usman %A Markle-Reid,Maureen %A Valaitis,Ruta %A Bartholomew,Amy %A Fitzpatrick-Lewis,Donna %A McAiney,Carrie %A Sherifali,Diana %+ Faculty of Health Sciences, School of Nursing, McMaster University, 1280 Main Street West, HSC 3N28F, Hamilton, ON, L8S 4K1, Canada, 1 905 525 9140 ext 21435, dsherif@mcmaster.ca %K burden %K caregivers %K chronic conditions %K education %K internet %K meta-analysis %K support %K Web-based interventions %D 2018 %7 26.10.2018 %9 Review %J J Med Internet Res %G English %X Background: Approaches to support the health and well-being of family caregivers of adults with chronic conditions are increasingly important given the key roles caregivers play in helping family members to live in the community. Web-based interventions to support caregivers have the potential to lessen the negative health impacts associated with caregiving and result in improved health outcomes. Objective: The primary objective of this systematic review and meta-analysis was to examine the effect of caregiver-focused, Web-based interventions, compared with no or minimal Web-based interventions, on caregiver outcomes. The secondary objective was to assess the effect of different types of Web-based interventions (eg, education, peer and professional psychosocial support, and electronic monitoring of the care recipient), compared with no or minimal Web-based interventions, on caregiver outcomes. Methods: MEDLINE, EMBASE, CIHAHL, PsychInfo, Cochrane, and AgeLine were searched from January 1995 to April 2017 for relevant randomized controlled trials (RCTs) or controlled clinical trials (CCTs) that compared caregiver-focused, Web-based intervention programs with no or minimal Web-based interventions for caregivers of adults with at least one chronic condition. Studies were included if they involved: adult family or friend caregivers (aged ≥18 years) of adults living in the community with a chronic condition; a caregiver-focused, Web-based intervention of education or psychosocial support or electronic monitoring of the care recipient; and general caregiver outcomes (ie, burden, life satisfaction, self-efficacy or mastery, reaction to problem behavior, self-esteem, strain, and social support). Title and abstract as well as full-text screening were completed in duplicate. Data were extracted by a single reviewer and verified by a second reviewer, and risk of bias assessments were completed accordingly. Where possible, data for these caregiver outcomes were meta-analyzed. Results: The search yielded 7927 unique citations, of which 294 studies were screened at full text. Of those, 14 studies met the inclusion criteria; 12 were RCTs and 1 study was a CCT. One study used an RCT design in 1 country and a CCT design in 2 other countries. The beneficial effects of any Web-based intervention program, compared with no or minimal Web-based intervention, resulted in a mean increase of 0.85 points (95% CI 0.12 to 1.57) for caregiver self-esteem, a mean increase of 0.36 points (95% CI 0.11 to 0.62) for caregiver self-efficacy or mastery, and a mean decrease of 0.32 points (95% CI −0.54 to −0.09) for caregiver strain. However, the results are based on poor-quality studies. Conclusions: The review found evidence for the positive effects of Web-based intervention programs on self-efficacy, self-esteem, and strain of caregivers of adults living with a chronic condition. Further high-quality research is needed to inform the effectiveness of specific types of Web-based interventions on caregiver outcomes. Trial Registration: PROSPERO CRD42018091715; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=91715 (Archived by WebCite at http://www.webcitation.org/738zAa5F5) %M 30368439 %R 10.2196/11247 %U http://www.jmir.org/2018/10/e11247/ %U https://doi.org/10.2196/11247 %U http://www.ncbi.nlm.nih.gov/pubmed/30368439 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 10 %P e11668 %T Geographic Representativeness of a Web-Based Smoking Cessation Intervention: Reach Equity Analysis %A Amato,Michael S %A Graham,Amanda L %+ Schroeder Institute, Truth Initiative, 900 G Street NW, Fourth Floor, Washington, DC, 20001, United States, 1 202 454 5767, mamato@truthinitiative.org %K smoking cessation %K health behavior %K internet %K population health %K rural health %K urban health %K health equity %K telemedicine %D 2018 %7 24.10.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Cigarette smoking is the leading cause of preventable death and disease in the United States. Smoking prevalence is higher in rural areas than in metropolitan areas, due partly to differences in access to cessation treatment. With internet use at 89% of all US adults, digital approaches could increase use of cessation treatment and reduce smoking. Objective: We investigated the extent to which smokers from rural areas use a digital cessation resource. We compared the geographic distribution of registered users of a free Web-based smoking cessation program with the geographic distribution of US smokers. Methods: We mapped user-provided ZIP codes to Rural-Urban Continuum Codes. A total of 59,050 of 118,574 users (49.80%) provided valid ZIP codes from 2013 to 2017. We used US National Survey of Drug Use and Health data from 2013 to 2017 to compare the geographic distribution of our sample of Web-based cessation users with the geographic distribution of US smokers. Reach ratios and 95% confidence intervals quantified the extent to which rural smokers’ representation in the sample was proportionate to their representation in the national smoking population. Reach ratios less than 1 indicate underrepresentation. Results: Smokers from rural areas were significantly underrepresented in 2013 (reach ratio 0.89, 95% CI 0.87-0.91) and 2014 (reach ratio 0.89, 95% CI 0.86-0.92), proportionally represented in 2015 (reach ratio 1.08, 95% CI 1.02-1.14) and 2016 (reach ratio 1.03, 95% CI 0.94-1.14), and proportionally overrepresented in 2017 (reach ratio 1.16, 95% CI 1.12-1.21). Smokers from Large Metro areas were proportionally represented in 2013 and 2014 but underrepresented in 2015 (reach ratio 0.97, 95% CI 0.94-1.00), 2016 (reach ratio 0.89, 95% CI 0.85-0.94), and 2017 (reach ratio 0.89, 95% CI 0.86-0.91). Conclusions: Results suggest that smokers from rural areas are more than proportionally reached by a long-standing digital cessation intervention. The underrepresentation of smokers from Large Metro areas warrants further study. %M 30355557 %R 10.2196/11668 %U http://www.jmir.org/2018/10/e11668/ %U https://doi.org/10.2196/11668 %U http://www.ncbi.nlm.nih.gov/pubmed/30355557 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 10 %P e11160 %T Web-Based Self-Management Programs for Bipolar Disorder: Insights From the Online, Recovery-Oriented Bipolar Individualised Tool Project %A Fletcher,Kathryn %A Foley,Fiona %A Murray,Greg %+ Centre for Mental Health, Faculty of Health, Arts and Design, Swinburne University of Technology, PO Box 218, Hawthorn, VIC, Melbourne, 3122, Australia, 61 3 9214 8900, kfletcher@swin.edu.au %K Web-based intervention %K bipolar disorder %K self-management %D 2018 %7 24.10.2018 %9 Viewpoint %J J Med Internet Res %G English %X Background: Bipolar disorder (BD) is a complex, relapsing mood disorder characterized by considerable morbidity and mortality. Web-based self-management interventions provide marked opportunities for several chronic mental health conditions. However, Web-based self-management programs targeting BD are underrepresented compared with programs targeting other psychiatric conditions. Objective: This paper aims at facilitating future research in the area of self-management of BD and draws insights from the development of one such intervention—the Online, Recovery-Oriented Bipolar Individualised Tool (ORBIT)—that is aimed at improving the quality of life of people with BD. Methods: We have discussed the opportunities and challenges in developing an engaging, evidence-based, safe intervention within the context of the following three nested domains: (1) intervention development; (2) scientific testing of the intervention; and (3) ethical framework including risk management. Results: We gained the following insights across the three abovementioned overlapping domains: Web-based interventions can be optimized through (1) codesign with consumers with lived experience to ensure relevance and appropriateness to the target audience; (2) novel content development processes that iteratively combine evidence-based information with lived experience perspectives, capitalizing on multimedia (eg, videos) that the digital health space provides; and (3) incorporating Web-based communities to connect end users and promote constructive engagement by access to a Web-based coach. Conclusions: Self-management is effective in BD, even for those on the more severe end of the spectrum. While there are challenges to be aware of, guided self-management programs, such as those offered by the ORBIT project, which are specifically developed for Web-based delivery provide highly accessible, engaging, and potentially provocative treatments for chronically ill populations who may otherwise have never engaged with treatment. Key questions about engagement, effectiveness, and cost-effectiveness will be answered by the ORBIT project over the next 18 months. %M 30355553 %R 10.2196/11160 %U http://www.jmir.org/2018/10/e11160/ %U https://doi.org/10.2196/11160 %U http://www.ncbi.nlm.nih.gov/pubmed/30355553 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 10 %P e10821 %T Effect of an eHealth Intervention to Reduce Sickness Absence Frequency Among Employees With Frequent Sickness Absence: Randomized Controlled Trial %A Notenbomer,Annette %A Roelen,Corné %A Groothoff,Johan %A van Rhenen,Willem %A Bültmann,Ute %+ Division Community and Occupational Medicine, Department of Health Sciences, University Medical Center Groningen, University of Groningen, Gebouw 3217 FA10, kamer 609, Antonius van Deusinglaan 1, Groningen, 9713 AV, Netherlands, 31 6 22417514, annette.notenbomer@gmail.com %K occupational health %K sick leave %K randomized controlled trial %K adult %K occupational health physicians %K eHealth %D 2018 %7 23.10.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Frequent sickness absence—that is, 3 or more episodes of sickness absence in 1 year—is a problem for employers and employees. Many employees who have had frequent sickness absence in a prior year also have frequent sickness absence in subsequent years: 39% in the first follow-up year and 61% within 4 years. Moreover, 19% have long-term sickness absence (≥6 weeks) in the first follow-up year and 50% within 4 years. We developed an electronic health (eHealth) intervention, consisting of fully automated feedback and advice, to use either as a stand-alone tool (eHealth intervention–only) or combined with consultation with an occupational physician (eHealth intervention–occupational physician). Objective: This study aimed to evaluate the effect of the eHealth intervention, with or without additional occupational physician consultation, to reduce sickness absence frequency for employees with frequent sickness absence, versus care as usual (CAU). Methods: This study was a three-armed randomized controlled trial. Employees with frequent sickness absence received invitational letters, which were distributed by their employers. The primary outcome measure was the number of register-based sickness absence episodes 12 months after completing the baseline questionnaire. Secondary outcome measures were register-based total sickness absence days and self-assessed burnout, engagement, and work ability. In a process evaluation 3 months after baseline, we examined adherence to the intervention and additional actions such as general practitioner and occupational physician visit, communication with the manager, and lifestyle change. Results: A total of 82 participants were included in the analyses, 21 in the eHealth intervention–only group, 31 in the eHealth intervention–occupational physician group, and 30 in the CAU group. We found no significant difference in sickness absence frequency between the groups at 1-year follow-up. Sickness absence frequency decreased in the eHealth intervention–only group from 3 (interquartile range, IQR 3-4) to 1 episode (IQR 0.3-2.8), in the eHealth intervention–occupational physician group from 4 (IQR 3-5) to 3 episodes (IQR 1-4), and in the CAU group from 3 (IQR 3-4) to 2 episodes (IQR 1-3). For secondary outcomes, we found no significant differences between the intervention groups and the control group. The process evaluation showed that only 3 participants from the eHealth intervention–occupational physician group visited the occupational physician on invitation. Conclusions: Among employees with frequent sickness absence, we found no effect from the eHealth intervention as a stand-alone tool in reducing sickness absence frequency, nor on total sickness absence days, burnout, engagement, or work ability. This might be due to low adherence to the intervention because of insufficient urgency to act. We cannot draw any conclusion on the effect of the eHealth intervention tool combined with an occupational physician consultation (eHealth intervention–occupational physician), due to very low adherence to the occupational physician consultation. An occupational physician consultation could increase a sense of urgency and lead to more focus and appropriate support. As this was the first effectiveness study among employees with frequent sickness absence, strategies to improve recruitment and adherence in occupational eHealth are included. Trial Registration: Netherlands Trial Register NTR4316; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4316 (Archived by WebCite at http://www.webcitation.org/713DHhOFU). %M 30355551 %R 10.2196/10821 %U http://www.jmir.org/2018/10/e10821/ %U https://doi.org/10.2196/10821 %U http://www.ncbi.nlm.nih.gov/pubmed/30355551 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 10 %P e10760 %T A Mobile Videoconference-Based Intervention on Stress Reduction and Resilience Enhancement in Employees: Randomized Controlled Trial %A Kim,Johanna Inyang %A Yun,Je-Yeon %A Park,Heyeon %A Park,Suk-Young %A Ahn,Youngsheen %A Lee,Hansol %A Kim,Tae-Kwon %A Yoon,Sooran %A Lee,Young-Joon %A Oh,Sohee %A Denninger,John W %A Kim,Bung-Nyun %A Kim,Jeong-Hyun %+ Seoul National University Bundang Hospital, 82, Gumi-ro 173 beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 13620, Seongnam,, Republic Of Korea, 82 31 787 2025, retrial3@hanmail.net %K employees %K mobile phone %K randomized controlled trial %K resilience enhancement %K stress reduction %K videoconferencing %D 2018 %7 22.10.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Videoconferencing-based treatments have shown great potential in increasing engagement and compliance by decreasing the barriers of time and distance. In general, employees tend to experience a lot of stress, but find it difficult to visit a clinic during office hours. Objective: The purpose of this study was to investigate the effectiveness of a mobile videoconference-based intervention for stress reduction and resilience enhancement in employees. Methods: In total, 81 participants were randomly allocated to one of the three conditions: mobile videoconferencing, in-person, and self-care; of these, 72 completed the study. All participants underwent assessment via self-reported questionnaires before, immediately after, and 1 month after the intervention. Intervention lasted for 4 weeks and consisted of elements of cognitive behavioral therapy, positive psychology, and meditation. Changes in clinical variables regarding stress and resilience across time were compared between treatment conditions. Results: There were significant condition × time effects on variables measuring perceived stress, resilience, emotional labor, and sleep, demonstrating significantly differential effects across time according to treatment condition. Moreover, there were significant effects of condition on perceived stress and occupational stress. There were no significant differences in any variable between the mobile videoconferencing and in-person conditions at 1 month after the intervention. Conclusions: Results indicate that both mobile videoconferencing and in-person interventions were comparably effective in decreasing stress and enhancing resilience. Further studies with a larger sample size and a longer follow-up period are warranted to investigate the long-term effect of mobile videoconferencing interventions. Trial Registration: ClinicalTrials.gov identifier NCT03256682; https://clinicaltrials.gov/ct2/show/NCT03256682 (Archived by WebCite at http://www.webcitation.org/71W77bwnR) %M 30348630 %R 10.2196/10760 %U http://www.jmir.org/2018/10/e10760/ %U https://doi.org/10.2196/10760 %U http://www.ncbi.nlm.nih.gov/pubmed/30348630 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 4 %P e10022 %T Users’ Intrinsic Goals Linked to Alcohol Dependence Risk Level and Engagement With a Health Promotion Website (Hello Sunday Morning): Observational Study %A Bradshaw,Emma L %A Sahdra,Baljinder K %A Calvo,Rafael A %A Mrvaljevich,Alex %A Ryan,Richard M %+ Institute for Positive Psychology and Education, Level 8, 33 Berry Street, North Sydney,, Australia, 61 0402940263, emma.bradshaw@myacu.edu.au %K alcohol dependence %K aspirations %K goals %K self-determination theory %K website engagement %D 2018 %7 22.10.2018 %9 Original Paper %J JMIR Ment Health %G English %X Background: Hello Sunday Morning (HSM) is a self-guided health promotion website with the aim to improve drinking culture. Members are encouraged to sign up for a 3-month period of alcohol abstention and record and track their progress and goals. Objective: This study used self-determination theory (SDT) to examine the nature of goals subscribed by HSM users to test the extent to which intrinsic goal pursuit was linked to lower alcohol dependency risk and higher engagement with the HSM website. Methods: HSM users (N=2216; 59.75%, 1324/2216, females; aged 18-79 years) completed the World Health Organization’s Alcohol Use Disorders Identification Test (WHO-AUDIT, which measures alcohol dependence risk level) at sign-up and at 4 and 6 months after sign-up. In addition, the website had a goals-subscription feature that allowed participants to share their goals. Two independent raters classified the goals according to a coding system we devised based on SDT, which proposes that intrinsic goals (eg, growth, relationships, community, and health) better promote positive outcomes than extrinsic goals (eg, wealth, fame, and image). Results: Although there was substantial (1016/2216, 45.84%) attrition of HSM users from sign-up to 6 months, the attrition rate could not be attributed to alcohol dependency risk because people in different WHO-AUDIT risk zones were equally likely to be missing at 4 and 6 months after sign-up. The SDT-driven coding of goals yielded the following categories: wealth and image (extrinsic goals); relationships, personal growth, community engagement, and physical health (intrinsic goals); and alcohol use-related goals (which were hard to classify as either extrinsic or intrinsic). Alcohol dependence risk level correlated positively with goals related to money (r=.16), personal growth (r=.17), relationships (r=.10), and alcohol use (r=.25). Website engagement correlated negatively with alcohol dependence risk level (r=.10) and positively with relationship (r=.10) and community goals (r=.12). Conclusions: HSM users with higher alcohol dependence risk tended to engage with the website less, but to the extent that they did, they tended to subscribe to goals related to alcohol use and improving their personal growth, relationships, and finances. In line with SDT, engagement with goals—particularly the intrinsic goals of connecting with close-others and the broader community—related to increased website engagement. Web-based tools intended to promote healthy behaviors in users may be effective in engaging their users if the users’ experience on the website supports the pursuit of intrinsic goals. %M 30348624 %R 10.2196/10022 %U http://mental.jmir.org/2018/4/e10022/ %U https://doi.org/10.2196/10022 %U http://www.ncbi.nlm.nih.gov/pubmed/30348624 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 10 %P e267 %T Promoting Psychological Well-Being at Work by Reducing Stress and Improving Sleep: Mixed-Methods Analysis %A Meyer,Denny %A Jayawardana,Madawa W %A Muir,Samuel D %A Ho,David Yen-Teh %A Sackett,Olivia %+ Department of Statistics, Data Science and Epidemiology, Swinburne University of Technology, John Street, Hawthorn, Melbourne, VIC 3122, Australia, 61 392144824, dmeyer@swin.edu.au %K exercise %K productivity %K healthy lifestyle %D 2018 %7 19.10.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Workplace programs designed to improve the health and psychological well-being of employees are becoming increasingly popular. However, there are mixed reports regarding the effectiveness of such programs and little analysis of what helps people to engage with such programs. Objective: This evaluation of a particularly broad, team-based, digital health and well-being program uses mixed methods to identify the elements of the program that reduce work stress and promote psychological well-being, sleep quality, and productivity of employees. Methods: Participation in the Virgin Pulse Global Challenge program during May to September 2016 was studied. Self-reported stress, sleep quality, productivity, and psychological well-being data were collected both pre- and postprogram. Participant experience data were collected through a third final survey. However, the response rates for the last 2 surveys were only 48% and 10%, respectively. A random forest was used to estimate the probability of the completion of the last 2 surveys based on the preprogram assessment data and the demographic data for the entire sample (N=178,350). The inverse of these estimated probabilities were used as weights in hierarchical linear models in an attempt to address any estimation bias caused by the low response rates. These linear models described changes in psychological well-being, stress, sleep, and productivity over the duration of the program in relation to gender and age, engagement with each of the modules, each of the program features, and participant descriptions of the Virgin Pulse Global Challenge. A 0.1% significance level was used due to the large sample size for the final survey (N=18,653). Results: The final analysis suggested that the program is more beneficial for older people, with 2.9% greater psychological well-being improvements observed on average in the case of women than men (P<.001). With one exception, all the program modules contributed significantly to the outcome measures with the following average improvements observed: psychological well-being, 4.1%-6.0%; quality of sleep, 3.2%-6.9%; work-related stress, 1.7%-6.8%; and productivity, 1.9%-4.2%. However, only 4 of the program features were found to have significant associations with the outcome measures with the following average improvements observed: psychological well-being, 3.7%-5.6%; quality of sleep, 3.4%-6.5%; work-related stress, 4.1%-6.4%; and productivity, 1.6%-3.2%. Finally, descriptions of the Virgin Pulse Global Challenge produced 5 text topics that were related to the outcome measures. Healthy lifestyle descriptions showed a positive association with outcomes, whereas physical activity and step count tracking descriptions showed a negative association with outcomes. Conclusions: The complementary use of qualitative and quantitative survey data in a mixed-methods analysis provided rich information that will inform the development of this and other programs designed to improve employee health. However, the low response rates and the lack of a control group are limitations, despite the attempts to address these problems in the analysis. %M 30341045 %R 10.2196/jmir.9058 %U https://www.jmir.org/2018/10/e267/ %U https://doi.org/10.2196/jmir.9058 %U http://www.ncbi.nlm.nih.gov/pubmed/30341045 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 4 %P e10698 %T Individualized Web-Based Exercise for the Treatment of Depression: Randomized Controlled Trial %A Haller,Nils %A Lorenz,Sonja %A Pfirrmann,Daniel %A Koch,Cora %A Lieb,Klaus %A Dettweiler,Ulrich %A Simon,Perikles %A Jung,Patrick %+ Department of Psychiatry and Psychotherapy, University Medical Center, Untere Zahlbacher Strasse 8, Mainz, 55131, Germany, 49 69633909719, patrick.jung@unimedizin-mainz.de %K depression %K exercise %K Web-based intervention %K eHealth %D 2018 %7 12.10.2018 %9 Original Paper %J JMIR Ment Health %G English %X Background: Due to the high prevalence of depressive disorders, it is mandatory to develop therapeutic strategies that provide universal access and require limited financial and human resources. Web-based therapeutic approaches fulfill these conditions. Objective: The objective of our study was to assess the feasibility, acceptability, and efficacy of a supervised, individualized 8-week Web-based exercise intervention conducted for patients with moderate to severe depression. Methods: We recruited 20 patients with unipolar depression and randomly assigned them into 2 groups (intervention, exercise program group, n=14, and control, treatment-as-usual group, n=6). At baseline, depressive symptoms were rated via the Quick Inventory of Depressive Symptomatology (QIDS) by patients themselves (QIDS–self-report, QIDS-SR) and by a blinded psychiatrist (QIDS–clinician rating, QIDS-C). In addition, performance diagnostics (lactate analysis, spiroergometry during a treadmill walking test) were conducted. Quality of life was assessed via the Short Form-36 questionnaire (SF-36) and self-efficacy via the General Self-Efficacy scale (GSE). In addition, habitual physical activity (HPA) was determined via the Baecke questionnaire. Participants of the intervention group received exercise schedules once weekly with endurance and strength training instructions. Rating of depressive symptoms was repeated after 6-12 days and 8 weeks; performance diagnostics and the completion of all the questionnaires were repeated after 8 weeks only. Results: The severity of depression subsided significantly in the intervention group after 8 weeks (median change in QIDS-SR: −5; interquartile range, IQR: −2 to −10), although it was already evident within the first 6-12 days (median change in QIDS-SR: −6; IQR: −2 to −8). During the intervention, participants undertook a median of 75 (IQR: 63 to 98) minutes of endurance training per week or 84% (16 [IQR: 9 to 19] of 19 [IQR: 15 to 21]) recommended endurance units in total. In addition, 9 (IQR: 4 to 12) of 10 (IQR: 8 to 13) recommended strength training exercise units were conducted during the 8 weeks. Performance diagnostics revealed a substantial increase in the maximum output in Watt for the intervention group after 8 weeks. Moreover, the intervention showed a favorable effect on SF-36 items “emotional well-being” and “social functioning” as well as on GSE and HPA scores. Conclusions: Our individualized Web-based exercise intervention for moderate to severe depression was highly accepted by the patients and led to a significant and clinically relevant improvement of depressive symptoms. Trial Registration: ClinicalTrials.gov NCT02874833; https://clinicaltrials.gov/ct2/show/NCT02874833 (Archived by WebCite at http://www.webcitation.org/72ZUUR4tE) %M 30314962 %R 10.2196/10698 %U http://mental.jmir.org/2018/4/e10698/ %U https://doi.org/10.2196/10698 %U http://www.ncbi.nlm.nih.gov/pubmed/30314962 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 4 %P e60 %T Efficacy and Moderation of Mobile App–Based Programs for Mindfulness-Based Training, Self-Compassion Training, and Cognitive Behavioral Psychoeducation on Mental Health: Randomized Controlled Noninferiority Trial %A Mak,Winnie WS %A Tong,Alan CY %A Yip,Sindy YC %A Lui,Wacy WS %A Chio,Floria HN %A Chan,Amy TY %A Wong,Celia CY %+ Diversity and Well-being Laboratory, Department of Psychology, The Chinese University of Hong Kong, Room 354, Sino Building, Department of Psychology, The Chinese University of Hong Kong, Shatin, NT,, China (Hong Kong), 852 39436577, wwsmak@cuhk.edu.hk %K mental health %K mobile apps %K mindfulness %K compassion %D 2018 %7 11.10.2018 %9 Original Paper %J JMIR Ment Health %G English %X Background: Mindfulness-based interventions, self-compassion training, and cognitive behavioral therapy have garnered much evidence in its salutary effects on mental health. With increasing application of smartphone and mobile technology on health promotion, this study investigated the efficacy and possible moderators of mindfulness, self-compassion, and cognitive behavioral psychoeducation training mobile apps in the improvement of mental health. Objective: The aim of this study was to examine the efficacy of 3 mobile app–based programs: mindfulness-based program, self-compassion program, and cognitive behavioral psychoeducation program in improving mental well-being and reducing psychological distress. Changes in mindful awareness and self-compassion were also assessed. To further delineate the suitability of each program for different types of individuals, individual difference variables (ie, discomfort with emotions and tolerance for ambiguity) were explored for potential moderation. Methods: This study was a 3-arm, randomized, controlled, noninferiority trial examining the efficacy of mindfulness-based program, self-compassion program, and cognitive behavioral psychoeducation. Participants were randomized into either 1 of the 3 conditions. Throughout the 4-week, 28-session program, participants spent 10-15 min daily reviewing the course content and practicing various related exercises. At preprogram, postprogram, and 3-month follow-up, participants also completed Web-based measures of mental well-being, psychological distress, mindful-awareness, and self-compassion as well as the proposed moderators. Results: Among the 2161 study participants, 508 and 349 completed the post- and 3-month follow-up assessment, respectively. All 3 conditions (mindfulness-based program: N=703; cognitive behavioral psychoeducation: N=753; self-compassion program: N=705) were found to be efficacious in improving mental well-being and reducing psychological distress. All conditions enhanced mindful awareness at postprogram. Significant interaction effect was found on self-compassion; cognitive behavioral psychoeducation and self-compassion program, but not mindfulness-based program, significantly enhanced self-compassion at postprogram. No significant differences regarding usage and users’ satisfaction were found among the 3 conditions. None of the proposed moderators were found to be significant. Conclusions: Mindfulness-based, self-compassion, and cognitive behavioral psychoeducation mobile apps were efficacious in improving mental well-being and reducing psychological distress among adults at postprogram and 3-month follow-up. Future app-based psychological training programs should consider gamification and personalization of content or feedback to enhance engagement and mitigate the high attrition rates that are common in app-based health promotion programs. Trial Registration: Chinese Clinical Trial Registry (ChiCTR) ChiCTR-TRC-13003468; http://www.chictr.org.cn/hvshowproject.aspx?id=6220 (Archived by WebCite at http://www.webcitation.org/734PlOz50) %M 30309837 %R 10.2196/mental.8597 %U http://mental.jmir.org/2018/4/e60/ %U https://doi.org/10.2196/mental.8597 %U http://www.ncbi.nlm.nih.gov/pubmed/30309837 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 10 %P e10361 %T Combining Technology and Research to Prevent Scald Injuries (the Cool Runnings Intervention): Randomized Controlled Trial %A Burgess,Jacqueline %A Watt,Kerrianne %A Kimble,Roy M %A Cameron,Cate M %+ Centre for Children's Burns and Trauma Research, University of Queensland, Child Health Research Centre, 62 Graham Street, Brisbane, 4021, Australia, 61 407789078, jacquii@uq.edu.au %K burns %K infant %K child %K mobile apps %K gamification %K injury %K prevention %K parent %D 2018 %7 10.10.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: New technologies, internet accessibility, social media, and increased smartphone ownership provide new opportunities for health researchers to communicate and engage target audiences. An innovative burn prevention intervention was developed using these channels. Objective: The aim of this study was to evaluate the efficacy of Cool Runnings, an app-based intervention to increase knowledge of childhood burn risk (specifically hot beverage scalds) and correct burn first aid among mothers of young children. Methods: This was a 2-group, parallel, single-blinded randomized controlled trial (RCT). Participants were women aged 18 years and above, living in Queensland, Australia, with at least 1 child aged 5-12 months at time of enrollment. The primary outcome measures were change in knowledge about risk of burns and correct burn first aid assessed via 2 methods: (1) overall score and (2) categorized as adequate (score=4) versus inadequate (score<4). Efficacy of gamification techniques was also assessed. Results: In total, 498 participants were recruited via social media and enrolled. At the 6-month follow-up, 244 participants completed the posttest questionnaire. Attrition rates in both groups were similar. Participants who remained in the study did not differ from those lost to follow-up on any characteristics except education level. Although similar at baseline, intervention group participants achieved significantly greater improvement in overall knowledge posttest than control group participants on both primary outcome measures (overall knowledge intervention: mean [SD] of overall knowledge 2.68 [SD 1.00] for intervention vs 2.13 [SD 1.03] for control; 20.7% [25/121] adequate in intervention vs 7.3% [2/123] in control). Consequently, the number needed to treat was 7.46. Logistic regression showed participants exposed to the highest level of disadvantage had 7.3 times higher odds of improved overall knowledge scores than participants in other levels of disadvantage. There were also significant correlations between gamification techniques and knowledge change (P<.001). In addition, odds of knowledge improvement between baseline and 6-month follow-up was higher in participants with low-moderate app activity compared with no app activity (odds ratio [OR] 8.59, 95% CI 2.9-25.02) and much higher in participants with high app activity (OR 18.26, 95% CI 7.1-46.8). Conclusions: Despite substantial loss to follow-up, this RCT demonstrates the Cool Runnings app was an effective intervention for improving knowledge about risks of hot beverage scalds and burn first aid in mothers of young children. The benefits of combining gamification elements in the intervention were also highlighted. Given the low cost and large reach of smartphone apps to deliver content to and engage with targeted populations, the results from this RCT provide important information on how smartphone apps can be used for widespread injury prevention campaigns and public health campaigns generally. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12616000019404; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369745&showOriginal=true&isReview=true (Archived by WebCite at http://www.webcitation.org/72b1E8gTW) %M 30305263 %R 10.2196/10361 %U http://www.jmir.org/2018/10/e10361/ %U https://doi.org/10.2196/10361 %U http://www.ncbi.nlm.nih.gov/pubmed/30305263 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 10 %P e10754 %T Predicting Adherence to Internet-Delivered Psychotherapy for Symptoms of Depression and Anxiety After Myocardial Infarction: Machine Learning Insights From the U-CARE Heart Randomized Controlled Trial %A Wallert,John %A Gustafson,Emelie %A Held,Claes %A Madison,Guy %A Norlund,Fredrika %A von Essen,Louise %A Olsson,Erik Martin Gustaf %+ Clinical Psychology in Healthcare, Department of Women's and Children's Health, Uppsala University, Dag Hammarskjölds väg 14B, SE-75185, Uppsala,, Sweden, 46 729999217, john.wallert@kbh.uu.se %K applied predictive modeling %K cardiac rehabilitation %K linguistics %K supervised machine learning %K recursive feature elimination %K treatment adherence and compliance %K Web-based interventions %D 2018 %7 10.10.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Low adherence to recommended treatments is a multifactorial problem for patients in rehabilitation after myocardial infarction (MI). In a nationwide trial of internet-delivered cognitive behavior therapy (iCBT) for the high-risk subgroup of patients with MI also reporting symptoms of anxiety, depression, or both (MI-ANXDEP), adherence was low. Since low adherence to psychotherapy leads to a waste of therapeutic resources and risky treatment abortion in MI-ANXDEP patients, identifying early predictors for adherence is potentially valuable for effective targeted care. Objectives: The goal of the research was to use supervised machine learning to investigate both established and novel predictors for iCBT adherence in MI-ANXDEP patients. Methods: Data were from 90 MI-ANXDEP patients recruited from 25 hospitals in Sweden and randomized to treatment in the iCBT trial Uppsala University Psychosocial Care Programme (U-CARE) Heart study. Time point of prediction was at completion of the first homework assignment. Adherence was defined as having completed more than 2 homework assignments within the 14-week treatment period. A supervised machine learning procedure was applied to identify the most potent predictors for adherence available at the first treatment session from a range of demographic, clinical, psychometric, and linguistic predictors. The internal binary classifier was a random forest model within a 3×10–fold cross-validated recursive feature elimination (RFE) resampling which selected the final predictor subset that best differentiated adherers versus nonadherers. Results: Patient mean age was 58.4 years (SD 9.4), 62% (56/90) were men, and 48% (43/90) were adherent. Out of the 34 potential predictors for adherence, RFE selected an optimal subset of 56% (19/34; Accuracy 0.64, 95% CI 0.61-0.68, P<.001). The strongest predictors for adherence were, in order of importance, (1) self-assessed cardiac-related fear, (2) sex, and (3) the number of words the patient used to answer the first homework assignment. Conclusions: For developing and testing effective iCBT interventions, investigating factors that predict adherence is important. Adherence to iCBT for MI-ANXDEP patients in the U-CARE Heart trial was best predicted by cardiac-related fear and sex, consistent with previous research, but also by novel linguistic predictors from written patient behavior which conceivably indicate verbal ability or therapeutic alliance. Future research should investigate potential causal mechanisms and seek to determine what underlying constructs the linguistic predictors tap into. Whether these findings replicate for other interventions outside of Sweden, in larger samples, and for patients with other conditions who are offered iCBT should also be investigated. Trial registration: ClinicalTrials.gov NCT01504191; https://clinicaltrials.gov/ct2/show/NCT01504191 (Archived at Webcite at http://www.webcitation.org/6xWWSEQ22) %M 30305255 %R 10.2196/10754 %U http://www.jmir.org/2018/10/e10754/ %U https://doi.org/10.2196/10754 %U http://www.ncbi.nlm.nih.gov/pubmed/30305255 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 4 %P e58 %T Interaction and Engagement with an Anxiety Management App: Analysis Using Large-Scale Behavioral Data %A Matthews,Paul %A Topham,Phil %A Caleb-Solly,Praminda %+ Data Science Group, Computer Science Research Centre, Department of Computer Science and Creative Technologies, University of the West of England, Coldharbour Lane, Bristol, BS161QY, United Kingdom, 44 11732 ext 83353, paul2.matthews@uwe.ac.uk %K anxiety %K mobile phone %K eMental health %K mHealth %D 2018 %7 1.10.2018 %9 Original Paper %J JMIR Ment Health %G English %X Background: SAM (Self-help for Anxiety Management) is a mobile phone app that provides self-help for anxiety management. Launched in 2013, the app has achieved over one million downloads on the iOS and Android platform app stores. Key features of the app are anxiety monitoring, self-help techniques, and social support via a mobile forum (“the Social Cloud”). This paper presents unique insights into eMental health app usage patterns and explores user behaviors and usage of self-help techniques. Objective: The objective of our study was to investigate behavioral engagement and to establish discernible usage patterns of the app linked to the features of anxiety monitoring, ratings of self-help techniques, and social participation. Methods: We use data mining techniques on aggregate data obtained from 105,380 registered users of the app’s cloud services. Results: Engagement generally conformed to common mobile participation patterns with an inverted pyramid or “funnel” of engagement of increasing intensity. We further identified 4 distinct groups of behavioral engagement differentiated by levels of activity in anxiety monitoring and social feature usage. Anxiety levels among all monitoring users were markedly reduced in the first few days of usage with some bounce back effect thereafter. A small group of users demonstrated long-term anxiety reduction (using a robust measure), typically monitored for 12-110 days, with 10-30 discrete updates and showed low levels of social participation. Conclusions: The data supported our expectation of different usage patterns, given flexible user journeys, and varying commitment in an unstructured mobile phone usage setting. We nevertheless show an aggregate trend of reduction in self-reported anxiety across all minimally-engaged users, while noting that due to the anonymized dataset, we did not have information on users also enrolled in therapy or other intervention while using the app. We find several commonalities between these app-based behavioral patterns and traditional therapy engagement. %M 30287415 %R 10.2196/mental.9235 %U https://mental.jmir.org/2018/4/e58/ %U https://doi.org/10.2196/mental.9235 %U http://www.ncbi.nlm.nih.gov/pubmed/30287415 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 10 %P e10455 %T Complaint-Directed Mini-Interventions for Depressive Symptoms: A Health Economic Evaluation of Unguided Web-Based Self-Help Interventions Based on a Randomized Controlled Trial %A Wijnen,Ben FM %A Lokman,Suzanne %A Leone,Stephanie %A Evers,Silvia MAA %A Smit,Filip %+ Centre for Economic Evaluation, Trimbos Institute, Netherlands Institute of Mental Health and Addiction, Da Costakade 45, Utrecht, 3521 VS, Netherlands, 31 030 297 1100, b.wijnen@maastrichtuniversity.nl %K prevention %K depression %K internet-based intervention %K economic evaluation %K quality of life %K cost-effectiveness analysis %K cost-utility analysis %K early medical intervention %K cost-benefit analysis %D 2018 %7 01.10.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression prevention and early intervention have become a top priority in the Netherlands, but with considerable room for improvement. To address this, Web-based complaint-directed mini-interventions (CDMIs) were developed. These brief and low-threshold interventions focus on psychological stress, sleep problems, and worry, because these complaints are highly prevalent, are demonstrably associated with depression, and have substantial economic impact. Objective: The objective of this economic evaluation was to examine the added value of Web-based, unguided, self-help CDMIs compared with a wait-listed control group with unrestricted access to usual care from both a societal and a health care perspective. Methods: This health economic evaluation was embedded in a randomized controlled trial. The study entailed 2 arms, in which 3 Web-based CDMIs were compared with a no-intervention waiting-list control group (which received the intervention after 3 months). We conducted measurements at baseline, and at 3 and 6 months. The primary outcome was the rate of responders to treatment on depressive symptoms as measured by the Inventory of Depressive Symptomatology Self-Report (IDS-SR). We estimated change in quality of life by calculating effect sizes (Cohen d) for individual pre- and posttreatment IDS-SR scores using a conversion factor to map a change in standardized effect size onto a corresponding change in utility. We calculated incremental cost-effectiveness ratios using bootstraps (5000 times) of seemingly unrelated regression equations and constructed cost-effectiveness acceptability curves for the costs per quality-adjusted life-year (QALY) gained. Results: Of 329 study participants, we randomly assigned 165 to the CDMI group. At 3 months, the rate of responders to treatment was 13.9% (23/165) in the CDMI group and 7.3% (12/164) in the control group. At 3 months, participants in the CDMI group gained 0.15 QALYs compared with baseline, whereas participants in the control group gained 0.03 QALYs. Average total costs per patient at 3 months were €2094 for the CDMI group and €2230 for the control group (excluding baseline costs). Bootstrapped seemingly unrelated regression equations models resulted in a dominant incremental cost-effectiveness ratio (ie, lower costs and a higher rate of responders to treatment) for the CDMI group compared with the control group at 3 months, with the same result for the costs per QALY gained. Various sensitivity analyses attested to the robustness of the findings of the main analysis. Conclusions: Brief and low-threshold Web-based, unguided, self-help CDMIs have the potential to be a cost-effective addition to usual care for adults with mild to moderate depressive symptoms. The CDMIs improved health status, while reducing participant health care costs, and hence dominated the care-as-usual control condition. As intervention costs were relatively low, and the internet is readily available in the Western world, we believe CDMIs can be easily implemented on a large scale. Trial Registration: Netherlands Trial Register NTR4612; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4612 (Archived by WebCite at http://www.webcitation.org/6n4PVYddM) %M 30274958 %R 10.2196/10455 %U https://www.jmir.org/2018/10/e10455/ %U https://doi.org/10.2196/10455 %U http://www.ncbi.nlm.nih.gov/pubmed/30274958 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 9 %P e10743 %T Web-Based Cognitive Behavioral Therapy Blended With Face-to-Face Sessions for Major Depression: Randomized Controlled Trial %A Nakao,Shigetsugu %A Nakagawa,Atsuo %A Oguchi,Yoshiyo %A Mitsuda,Dai %A Kato,Noriko %A Nakagawa,Yuko %A Tamura,Noriko %A Kudo,Yuka %A Abe,Takayuki %A Hiyama,Mitsunori %A Iwashita,Satoru %A Ono,Yutaka %A Mimura,Masaru %+ Clinical and Translational Research Center, Keio University Hospital, 35, Shinanomachi, Shinjuku-Ku, Tokyo, 160-8582, Japan, 81 3 3353 1211, anakagawa@keio.jp %K blended cognitive behavioral therapy %K cognitive behavioral therapy %K major depressive disorder %K major depression %K randomized controlled trial %D 2018 %7 21.9.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Meta-analyses of several randomized controlled trials have shown that cognitive behavioral therapy (CBT) has comparable efficacy to antidepressant medication, but therapist availability and cost-effectiveness is a problem. Objective: This study aimed to evaluate the effectiveness of Web-based CBT blended with face-to-face sessions that reduce therapist time in patients with major depression who were unresponsive to antidepressant medications. Methods: A 12-week, assessor-masked, parallel-group, waiting- list controlled, randomized trial was conducted at 3 medical institutions in Tokyo. Outpatients aged 20-65 years with a primary diagnosis of major depression who were taking ≥1 antidepressant medications at an adequate dose for ≥6 weeks and had a 17-item GRID-Hamilton Depression Rating Scale (HAMD) score of ≥14 were randomly assigned (1:1) to blended CBT or waiting-list groups using a computer allocation system, stratified by the study site with the minimization method, to balance age and baseline GRID-HAMD score. The CBT intervention was given in a combined format, comprising a Web-based program and 12 45-minute face-to-face sessions. Thus, across 12 weeks, a participant could receive up to 540 minutes of contact with a therapist, which is approximately two-thirds of the therapist contact time provided in the conventional CBT protocol, which typically provides 16 50-minute sessions. The primary outcome was the alleviation of depressive symptoms, as measured by a change in the total GRID-HAMD score from baseline (at randomization) to posttreatment (at 12 weeks). Moreover, in an exploratory analysis, we investigated whether the expected positive effects of the intervention were sustained during follow-up, 3 months after the posttreatment assessment. Analyses were performed on an intention-to-treat basis, and the primary outcome was analyzed using a mixed-effects model for repeated measures. Results: We randomized 40 participants to either blended CBT (n=20) or waiting-list (n=20) groups. All patients completed the 12-week treatment protocol and were included in the intention-to-treat analyses. Participants in the blended CBT group had significantly alleviated depressive symptoms at week 12, as shown by greater least squares mean changes in the GRID-HAMD score, than those in the waiting list group (−8.9 points vs −3.0 points; mean between-group difference=−5.95; 95% CI −9.53 to −2.37; P<.001). The follow-up effects within the blended CBT group, as measured by the GRID-HAMD score, were sustained at the 3-month follow-up (week 24) and posttreatment (week 12): posttreatment, 9.4 (SD 5.2), versus follow-up, 7.2 (SD 5.7); P=.009. Conclusions: Although our findings warrant confirmation in larger and longer term studies with active controls, these suggest that a combined form of CBT is effective in reducing depressive symptoms in patients with major depression who are unresponsive to antidepressant medications. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry: UMIN000009242; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010852 (Archived by WebCite at http://www.webcitation. org/729VkpyYL) %M 30249583 %R 10.2196/10743 %U http://www.jmir.org/2018/9/e10743/ %U https://doi.org/10.2196/10743 %U http://www.ncbi.nlm.nih.gov/pubmed/30249583 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 9 %P e179 %T An mHealth App for Self-Management of Chronic Lower Back Pain (Limbr): Pilot Study %A Selter,Aliza %A Tsangouri,Christina %A Ali,Sana B %A Freed,Diana %A Vatchinsky,Adrian %A Kizer,James %A Sahuguet,Arnaud %A Vojta,Deneen %A Vad,Vijay %A Pollak,JP %A Estrin,Deborah %+ Cornell Tech, 2 W Loop Rd, New York, NY,, United States, 1 646 971 3716, jpp9@cornell.edu %K low back pain %K chronic disease %K self-assessment %K telemedicine %K self-management %K activities of daily living %K pain %K rehabilitation %D 2018 %7 17.09.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Although mobile health (mHealth) interventions can help improve outcomes among patients with chronic lower back pain (CLBP), many available mHealth apps offer content that is not evidence based. Limbr was designed to enhance self-management of CLBP by packaging self-directed rehabilitation tutorial videos, visual self-report tools, remote health coach support, and activity tracking into a suite of mobile phone apps, including Your Activities of Daily Living, an image-based tool for quantifying pain-related disability. Objective: The aim is to (1) describe patient engagement with the Limbr program, (2) describe patient-perceived utility of the Limbr program, and (3) assess the validity of the Your Activities of Daily Living module for quantifying functional status among patients with CLBP. Methods: This was a single-arm trial utilizing a convenience sample of 93 adult patients with discogenic back pain who visited a single physiatrist from January 2016 to February 2017. Eligible patients were enrolled in 3-month physical therapy program and received the Limbr mobile phone app suite for iOS or Android. The program included three daily visual self-reports to assess pain, activity level, and medication/coping mechanisms; rehabilitation video tutorials; passive activity-level measurement; and chat-based health coaching. Patient characteristics, patient engagement, and perceived utility were analyzed descriptively. Associations between participant characteristics and program interaction were analyzed using multiple linear regression. Associations between Your Activities of Daily Living and Oswestry Disability Index (ODI) assessments were examined using Pearson correlation and hierarchical linear modeling. Results: A total of 93 participants were enrolled; of these, 35 (38%) completed the program (age: mean 46, SD 16 years; female: 22/35, 63%). More than half of completers finished assessments at least every 3 days and 70% (19/27) used the rehabilitation component at least once a week. Among respondents to a Web-based feedback survey, 76% (16/21) found the daily notifications helped them remember to complete their exercises, 81% (17/21) found the system easy to use, and 62% (13/21) rated their overall experience good or excellent. Baseline Your Activities of Daily Living score was a significant predictor of baseline ODI score, with ODI increasing by 0.30 units for every 1-unit increase in Your Activities of Daily Living (P<.001). Similarly, hierarchical linear modeling analysis indicated that Your Activities of Daily Living daily assessment scores were significant predictors of ODI scores over the course of the study (P=.01). Conclusions: Engagement among participants who completed the Limbr program was high, and program utility was rated positively by most respondents. Your Activities of Daily Living was significantly associated with ODI scores, supporting the validity of this novel tool. Future studies should assess the effect of Limbr on clinical outcomes, evaluate its use among a wider patient sample, and explore strategies for reducing attrition. Trial Registration: ClinicalTrials.gov NCT03040310; https://clinicaltrials.gov/ct2/show/NCT03040310 (Archived by WebCite at http://www.webcitation.org/722mEvAiv) %M 30224333 %R 10.2196/mhealth.8256 %U http://mhealth.jmir.org/2018/9/e179/ %U https://doi.org/10.2196/mhealth.8256 %U http://www.ncbi.nlm.nih.gov/pubmed/30224333 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 3 %N 3 %P e13 %T Web-Based Interventions for Depression in Individuals with Diabetes: Review and Discussion %A Franco,Pamela %A Gallardo,Ana María %A Urtubey,Xavier %+ Psychology Department, Universidad del Desarrollo, Av Plaza 680, Santiago, 7610658, Chile, 56 223279110, p.franco@udd.cl %K Web-based intervention %K internet %K depression %K diabetes %K cognitive behavioral therapy %D 2018 %7 14.09.2018 %9 Review %J JMIR Diabetes %G English %X Background: Depression is twice as common in people with diabetes, and this comorbidity worsens the course of both pathologies. In clinical practice guidelines, screening and treatment of depression in patients with diabetes are highly recommended. However, depression is still both underrecognized and undertreated. To find ways to enhance their reach, psychological treatments have taken advantage of benefits of internet and technological devices as delivery formats, providing interventions that require considerably less (or even no) interaction time with therapists. Web-based treatments hold promise for effective interventions at low cost with positive results. Objective: The objectives of this review were to describe Web-based interventions for depression in individuals with diabetes and to discuss these studies’ procedures and findings in light of evidence from a wider range of interventions for depression and diabetes. Methods: A comprehensive literature search was conducted in PsycINFO and MEDLINE electronic databases. Studies were included when they met the following selection criteria: the study was available in a peer-reviewed journal mainly publishing studies written in either English or Spanish; the studied sample comprised individuals with diabetes; the intervention targeted depression symptomatology; the intervention was accessible via the internet; and the intervention was accessible via the internet with little or no clinician support. Results: Overall, 5 research studies were identified in the review. All studies were randomized controlled trials, and most used a wait list as a control; 4 studies reported treatment dropout, rates of which varied from 13% to 42%. Studies supported the notion that the Web-based format is a suitable psychology service delivery option for diabetic individuals with depression (effect size range for completers 0.7-0.89). Interventions varied in their characteristics but most were clinical-assisted, had a cognitive behavioral therapy approach, used diabetes-specific topics, had a weekly modular display, used homework assignments, and had some adherence management strategy. These characteristics are consistent with the intervention features associated with positive results in the literature. Conclusions: The analyzed studies’ findings and procedures are discussed in light of evidence drawn from a wider range of reviews on Web-based interventions for depression and diabetes. Consistent with previous research on depression treatment, Web-based interventions for depression among individuals with diabetes have shown positive results. Future research should contribute new evidence as to why these interventions are effective, for whom, and which particular aspects can increase patients’ adherence. %M 30291082 %R 10.2196/diabetes.9694 %U http://diabetes.jmir.org/2018/3/e13/ %U https://doi.org/10.2196/diabetes.9694 %U http://www.ncbi.nlm.nih.gov/pubmed/30291082 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 9 %P e11652 %T Using Partially-Observed Facebook Networks to Develop a Peer-Based HIV Prevention Intervention: Case Study %A Khanna,Aditya Subhash %A Goodreau,Steven Michael %A Michaels,Stuart %A Schneider,John Alexis %+ Chicago Center for HIV Elimination, Department of Medicine, The University of Chicago, 5841 S Maryland Avenue, MC 5065, Chicago, IL, 60637, United States, 1 773 834 5635, akhanna@medicine.bsd.uchicago.edu %K African Americans %K computer simulation %K data mining %K HIV infections %K peer group %K pre-exposure prophylaxis %K sexual and gender minorities %K social media %K social networking %D 2018 %7 14.09.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: This is a case study from an HIV prevention project among young black men who have sex with men. Individual-level prevention interventions have had limited success among young black men who have sex with men, a population that is disproportionately affected by HIV; peer network–based interventions are a promising alternative. Facebook is an attractive digital platform because it enables broad characterization of social networks. There are, however, several challenges in using Facebook data for peer interventions, including the large size of Facebook networks, difficulty in assessing appropriate methods to identify candidate peer change agents, boundary specification issues, and partial observation of social network data. Objective: This study aimed to explore methodological challenges in using social Facebook networks to design peer network–based interventions for HIV prevention and present techniques to overcome these challenges. Methods: Our sample included 298 uConnect study respondents who answered a bio-behavioral survey in person and whose Facebook friend lists were downloaded (2013-2014). The study participants had over 180,000 total Facebook friends who were not involved in the study (nonrespondents). We did not observe friendships between these nonrespondents. Given the large number of nonrespondents whose networks were partially observed, a relational boundary was specified to select nonrespondents who were well connected to the study respondents and who may be more likely to influence the health behaviors of young black men who have sex with men. A stochastic model-based imputation technique, derived from the exponential random graph models, was applied to simulate 100 networks where unobserved friendships between nonrespondents were imputed. To identify peer change agents, the eigenvector centrality and keyplayer positive algorithms were used; both algorithms are suitable for identifying individuals in key network positions for information diffusion. For both algorithms, we assessed the sensitivity of identified peer change agents to the imputation model, the stability of identified peer change agents across the imputed networks, and the effect of the boundary specification on the identification of peer change agents. Results: All respondents and 78.9% (183/232) of nonrespondents selected as peer change agents by eigenvector on the imputed networks were also selected as peer change agents on the observed networks. For keyplayer, the agreement was much lower; 42.7% (47/110) and 35.3% (110/312) of respondent and nonrespondent peer change agents, respectively, selected on the imputed networks were also selected on the observed network. Eigenvector also produced a stable set of peer change agents across the 100 imputed networks and was much less sensitive to the specified relational boundary. Conclusions: Although we do not have a gold standard indicating which algorithm produces the most optimal set of peer change agents, the lower sensitivity of eigenvector centrality to key assumptions leads us to conclude that it may be preferable. The methods we employed to address the challenges in using Facebook networks may prove timely, given the rapidly increasing interest in using online social networks to improve population health. %M 30217793 %R 10.2196/11652 %U http://www.jmir.org/2018/9/e11652/ %U https://doi.org/10.2196/11652 %U http://www.ncbi.nlm.nih.gov/pubmed/30217793 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 9 %P e10326 %T Mindfulness-Based Resilience Training in the Workplace: Pilot Study of the Internet-Based Resilience@Work (RAW) Mindfulness Program %A Joyce,Sadhbh %A Shand,Fiona %A Bryant,Richard A %A Lal,Tara J %A Harvey,Samuel B %+ School of Psychiatry, Faculty of Medicine, University of New South Wales, The Black Dog Institute, Hospital Road, Randwick, 2031, Australia, 61 401297711, sadhbh.joyce@unsw.edu.au %K resilience training %K workplace mental health %K occupational health %K wellbeing %K online intervention %K employee resilience %K health and safety %K psychological health %D 2018 %7 11.09.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: The impact of mental illness on society is far reaching and has been identified as the leading cause of sickness absence and work disability in most developed countries. By developing evidence-based solutions that are practical, affordable, and accessible, there is potential to deliver substantial economic benefits while improving the lives of individual workers. Academic and industry groups are now responding to this public health issue. A key focus is on developing practical solutions that enhance the mental health and psychological resilience of workers. A growing body of research suggests resilience training may play a pivotal role in the realm of public health and prevention, particularly with regards to protecting the long-term well-being of workers. Objective: Our aim is to examine whether a mindfulness-based resilience-training program delivered via the internet is feasible and engaging to a group of high-risk workers. Additionally, we aim to measure the effect of the Resilience@Work Resilience@Work Mindfulness program on measures of resilience and related skills. Methods: The current pilot study recruited 29 full-time firefighters. Participants were enrolled in the 6-session internet-based resilience-training program and were administered questionnaires prior to training and directly after the program ended. Measurements examined program feasibility, psychological resilience, experiential avoidance, and thought entanglement. Results: Participants reported greater levels of resilience after Resilience@Work training compared to baseline, with a mean increase in their overall resilience score of 1.5 (95% CI -0.25 to 3.18, t14=1.84, P=.09). Compared to baseline, participants also reported lower levels of psychological inflexibility and experiential avoidance following training, with a mean decrease of -1.8 (95% CI -3.78 to 0.20, t13=-1.94, P=.07). With regards to cognitive fusion (thought entanglement), paired-samples t tests revealed a trend towards reduction in mean scores post training (P=.12). Conclusions: This pilot study of the Resilience@Work program suggests that a mindfulness-based resilience program delivered via the Internet is feasible in a high-risk workplace setting. In addition, the firefighters using the program showed a trend toward increased resilience and psychological flexibility. Despite a number of limitations, the results of this pilot study provide some valuable insights into what form of resilience training may be viable in occupational settings particularly among those considered high risk, such as emergency workers. To the best of our knowledge, this is the first time a mindfulness-based resilience-training program delivered wholly via the internet has been tested in the workplace. %M 30206055 %R 10.2196/10326 %U http://www.jmir.org/2018/9/e10326/ %U https://doi.org/10.2196/10326 %U http://www.ncbi.nlm.nih.gov/pubmed/30206055 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 9 %P e259 %T Using New and Innovative Technologies to Assess Clinical Stage in Early Intervention Youth Mental Health Services: Evaluation Study %A Ospina-Pinillos,Laura %A Davenport,Tracey %A Iorfino,Frank %A Tickell,Ashleigh %A Cross,Shane %A Scott,Elizabeth M %A Hickie,Ian B %+ Brain and Mind Centre, The University of Sydney, Shops 1-3, 66-70 Parramatta Road, Camperdown, Sydney,, Australia, 61 028 627 6946, laura.ospinapinillos@sydney.edu.au %K staging model %K mental health %K primary health care %K telemedicine %K symptom assessment health service reform %D 2018 %7 10.09.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Globally there is increasing recognition that new strategies are required to reduce disability due to common mental health problems. As 75% of mental health and substance use disorders emerge during the teenage or early adulthood years, these strategies need to be readily accessible to young people. When considering how to provide such services at scale, new and innovative technologies show promise in augmenting traditional clinic-based services. Objective: The aim of this study was to test new and innovative technologies to assess clinical stage in early intervention youth mental health services using a prototypic online system known as the Mental Health eClinic (MHeC). Methods: The online assessment within the MHeC was compared directly against traditional clinician assessment within 2 Sydney-based youth-specific mental health services (headspace Camperdown and headspace Campbelltown). A total of 204 young people were recruited to the study. Eligible participants completed both face-to-face and online assessments, which were randomly allocated and counterbalanced at a 1-to-3 ratio. These assessments were (1) a traditional 45- to 60-minute headspace face-to-face assessment performed by a Youth Access Clinician and (2) an approximate 60-minute online assessment (including a self-report Web-based survey, immediate dashboard of results, and a video visit with a clinician). All assessments were completed within a 2-week timeframe from initial presentation. Results: Of the 72 participants who completed the study, 71% (51/72) were female and the mean age was 20.4 years (aged 16 to 25 years); 68% (49/72) of participants were recruited from headspace Camperdown and the remaining 32% (23/72) from headspace Campbelltown. Interrater agreement of participants’ stage, as determined after face-to-face assessment or online assessment, demonstrated fair agreement (kappa=.39, P<.001) with concordance in 68% of cases (49/72). Among the discordant cases, those who were allocated to a higher stage by online raters were more likely to report a past history of mental health disorders (P=.001), previous suicide planning (P=.002), and current cannabis misuse (P=.03) compared to those allocated to a lower stage. Conclusions: The MHeC presents a new and innovative method for determining key clinical service parameters. It has the potential to be adapted to varied settings in which young people are connected with traditional clinical services and assist in providing the right care at the right time. %M 30201602 %R 10.2196/jmir.9966 %U http://www.jmir.org/2018/9/e259/ %U https://doi.org/10.2196/jmir.9966 %U http://www.ncbi.nlm.nih.gov/pubmed/30201602 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 2 %N 2 %P e18 %T Adapting a Behavioral Weight Loss Intervention for Delivery via Facebook: A Pilot Series Among Low-Income Postpartum Women %A Silfee,Valerie J %A Lopez-Cepero,Andrea %A Lemon,Stephenie C %A Estabrook,Barbara %A Nguyen,Oanh %A Wang,Monica L %A Rosal,Milagros C %+ Division of Preventive and Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA, 01655, United States, 1 508 856 3173, Milagros.Rosal@umassmed.edu %K Facebook %K health disparities %K postpartum women %K social media %K weight loss %D 2018 %7 10.09.2018 %9 Original Paper %J JMIR Formativ Res %G English %X Background: Efforts to translate evidence-based weight loss interventions, such as the Diabetes Prevention Program (DPP), to low-income postpartum women have resulted in poor intervention attendance and high attrition. Strategies that improve engagement and retention in this population are needed to maximize the reach of evidence-based weight loss interventions. Objective: The objective of this study was to adapt a DPP-based weight loss intervention (Fresh Start) for Facebook delivery and to evaluate its feasibility among low-income postpartum women. Methods: This study comprised 3 single-group pilot studies where feasibility outcomes iteratively informed changes from one pilot to the next. We paralleled the in-person program for Facebook delivery by translating the protocol to a content library of Facebook posts with additional posts from lifestyle coaches. Low-income postpartum women were recruited from Women, Infants, and Children (WIC) clinics in Worcester, Massachusetts. Participants were enrolled into a 16-week weight loss intervention delivered via Facebook. During the first 8 weeks, Facebook intervention posts were delivered 2 times per day, with additional posts from coaches aiming to stimulate interaction among participants or respond to participants’ questions and challenges. For the following 8 weeks, posts were delivered once per day without additional coaching. Feasibility outcomes were engagement (defined by number of likes, comments, and posts measured throughout intervention delivery), acceptability, and retention (survey at follow-up and assessment completion rate, respectively). Changes in weight were also assessed at baseline and follow-up. Results: Pilot 1 had a retention rate of 89% (24/27), and on average, 62% (17/27) of women actively engaged with the group each week during the 8-week coached phase. Mean weight loss was 2.6 (SD 8.64) pounds, and 79% (19/27) would recommend the program to a friend. Pilot 2 had a retention rate of 83% (20/24), and on average, 55% (13/24) of women actively engaged with the group weekly during the 8-week coached phase. Mean weight loss was 2.5 (SD 9.23) pounds, and 80% (16/24) would recommend the program to a friend. Pilot 3 had a retention rate of 88% (14/16), and on average, 67% (11/16) of women actively engaged with the group weekly during the 8-week coached phase. Mean weight loss was 7.0 (SD 11.6) pounds, and 100% (16/16) would recommend the program to a friend. Conclusions: Our findings demonstrated that a Facebook-delivered intervention was acceptable and could be feasibly delivered to low-income postpartum women. Future research is needed to evaluate the efficacy of a Facebook-delivered weight loss intervention. %M 30684423 %R 10.2196/formative.9597 %U http://formative.jmir.org/2018/2/e18/ %U https://doi.org/10.2196/formative.9597 %U http://www.ncbi.nlm.nih.gov/pubmed/30684423 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 2 %N 2 %P e19 %T A Stress Management App Intervention for Cancer Survivors: Design, Development, and Usability Testing %A Børøsund,Elin %A Mirkovic,Jelena %A Clark,Matthew M %A Ehlers,Shawna L %A Andrykowski,Michael A %A Bergland,Anne %A Westeng,Marianne %A Solberg Nes,Lise %+ Center for Shared Decision Making and Collaborative Care Research, Division of Medicine, Oslo University Hospital, PO Box 4950 Nydalen, Oslo, 0424, Norway, 47 92667262, elin.borosund@rr-research.no %K stress management %K mindfulness %K cancer %K eHealth %K mHealth %K mobile apps %K development %K usability %K user-centered design %K mobile phones %D 2018 %7 06.09.2018 %9 Original Paper %J JMIR Formativ Res %G English %X Background: Distress is prevalent in cancer survivors. Stress management interventions can reduce distress and improve quality of life for cancer patients, but many people with cancer are unfortunately not offered or able to attend such in-person stress management interventions. Objective: The objective of this study was to develop an evidence-based stress management intervention for patients living with cancer that can be delivered electronically with wide reach and dissemination. This paper describes the design and development process of a technology-based stress management intervention for cancer survivors, including the exploration phase, intervention content development, iterative software development (including design, development, and formative evaluation of low- and high-level prototypes), and security and privacy considerations. Methods: Design and development processes were iterative and performed in close collaboration with key stakeholders (N=48). In the exploration phase, identifying needs and requirements for the intervention, 28 participants gave input, including male and female cancer survivors (n=11) representing a wide age range (31-81 years) and cancer diagnoses, healthcare providers (n=8) including psychosocial oncology experts, and eHealth experts (n=9) including information technology design and developers. To ensure user involvement in each phase various user-centered design and service design methods were included, such as interviews, usability testing, and think aloud processes. Overall, participants were involved usability testing in the software development and formative evaluation phase, including cancer survivors (n=6), healthy volunteers (n=7), health care providers (n=2), and eHealth experts (n=5). Intervention content was developed by stress management experts based on well-known cognitive behavioral stress management strategies and adjusted to electronic format through multiple iterations with stakeholders. Privacy and security issues were considered throughout. Results: The design and development process identified a variety of stakeholder requirements. Cancer survivors preferred stress management through a mobile app rather than through a personal computer (PC) and identified usefulness, easy access, user friendliness, use of easily understandable language, and many brief sections rather than longer ones as important components of the intervention. These requirements were also supported by recommendations from health care providers and eHealth experts. The final intervention was named StressProffen and the hospital Privacy and Security Protection Committee was part of the final intervention approval to also ensure anchoring in the hospital organization. Conclusions: Interventions, even evidence-based, have little impact if not actively used. This study illustrates how user-centered design and service design can be applied to identify and incorporate essential stakeholder aspects in the entire design and development process. In combination with evidence-based concepts, this process facilitated development of a stress management intervention truly designed for the end users, in this case, cancer survivors. Trial Registration: ClinicalTrials.gov NCT02939612; https://clinicaltrials.gov/ct2/show/NCT02939612 (Archived at WebCite at http://www.webcitation.org/71l9HcfcB) %M 30684438 %R 10.2196/formative.9954 %U http://formative.jmir.org/2018/2/e19/ %U https://doi.org/10.2196/formative.9954 %U http://www.ncbi.nlm.nih.gov/pubmed/30684438 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 9 %P e10302 %T Patient Experiences of Web-Based Cognitive Behavioral Therapy for Heart Failure and Depression: Qualitative Study %A Lundgren,Johan %A Johansson,Peter %A Jaarsma,Tiny %A Andersson,Gerhard %A Kärner Köhler,Anita %+ Division of Nursing Science, Department of Social and Welfare Studies, Linköping University, Campus Norrköping, Kåkenhus, Norrköping, SE-601 74, Sweden, 46 01136 ext 3592, johan.lundgren@liu.se %K cognitive therapy %K content analysis %K depression %K heart failure %K internet %K patient experience %K telehealth %D 2018 %7 05.09.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based cognitive behavioral therapy (wCBT) has been proposed as a possible treatment for patients with heart failure and depressive symptoms. Depressive symptoms are common in patients with heart failure and such symptoms are known to significantly worsen their health. Although there are promising results on the effect of wCBT, there is a knowledge gap regarding how persons with chronic heart failure and depressive symptoms experience wCBT. Objective: The aim of this study was to explore and describe the experiences of participating and receiving health care through a wCBT intervention among persons with heart failure and depressive symptoms. Methods: In this qualitative, inductive, exploratory, and descriptive study, participants with experiences of a wCBT program were interviewed. The participants were included through purposeful sampling among participants previously included in a quantitative study on wCBT. Overall, 13 participants consented to take part in this study and were interviewed via telephone using an interview guide. Verbatim transcripts from the interviews were qualitatively analyzed following the recommendations discussed by Patton in Qualitative Research & Evaluation Methods: Integrating Theory and Practice. After coding each interview, codes were formed into categories. Results: Overall, six categories were identified during the analysis process. They were as follows: “Something other than usual health care,” “Relevance and recognition,” “Flexible, understandable, and safe,” “Technical problems,” “Improvements by real-time contact,” and “Managing my life better.” One central and common pattern in the findings was that participants experienced the wCBT program as something they did themselves and many participants described the program as a form of self-care. Conclusions: Persons with heart failure and depressive symptoms described wCBT as challenging. This was due to participants balancing the urge for real-time contact with perceived anonymity and not postponing the work with the program. wCBT appears to be a valuable tool for managing depressive symptoms. %M 30185405 %R 10.2196/10302 %U http://www.jmir.org/2018/9/e10302/ %U https://doi.org/10.2196/10302 %U http://www.ncbi.nlm.nih.gov/pubmed/30185405 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 2 %N 2 %P e11138 %T Conversation Within a Facebook Smoking Cessation Intervention Trial For Young Adults (Tobacco Status Project): Qualitative Analysis %A McKelvey,Karma %A Ramo,Danielle %+ Weill Institute for Neurosciences, Department of Psychiatry, University of California San Francisco, 401 Parnassus Avenue, San Francisco, CA, 94143, United States, 1 4154767695, danielle.ramo@ucsf.edu %K Facebook %K intervention %K qualitative analysis %K smoking cessation %K social media %K young adults %D 2018 %7 04.09.2018 %9 Original Paper %J JMIR Formativ Res %G English %X Background: Smoking cessation interventions delivered through social media have the potential to engage young people in behavior change. Objective: The aim of this study was to describe participant-posted messages in a Facebook smoking cessation intervention for young adults to discern support for behavior change. Methods: We qualitatively analyzed data from the treatment arm of a randomized trial testing the efficacy of the Tobacco Status Project Facebook intervention. Young adults (N=138) aged 18-25 years (female: 81/138, 58.7%; white: 101/138, 73.2%; mean age 21 years) were recruited using Facebook and placed into one of the 15 secret Facebook groups based on readiness-to-quit smoking. Messages posted to groups for 90 consecutive days were tailored to readiness-to-quit: Not Ready (46/138, 33.3%), Thinking (66/138, 47.8%), and Getting Ready (26/138, 18.8%). Groups were randomized to receive up to US $90 for posting or no incentive. Two independent coders conducted open coding of user posts. We considered content by readiness-to-quit group and incentive condition. Results: There were 4 dominant themes across all groups: coping skills, friends and family, motivation to quit, and benefits of quitting. The dominant themes in Not Ready groups were friends and family (incentive) and motivation to quit (no incentive), whereas coping skills was the dominant theme in Thinking and Getting Ready groups. The expression of themes varied by readiness-to-quit group but not by incentive condition. Conclusions: Intervention messages tailored to readiness-to-quit appear useful in eliciting the desired responses from young adult smokers, with limited influence by monetary incentive. Trial Registration: ClinicalTrials.gov NCT02207036; https://clinicaltrials.gov/ct2/show/NCT02207036 (Archived by WebCite at http://www.webcitation.org/722XAEAAz) %M 30684432 %R 10.2196/11138 %U http://formative.jmir.org/2018/2/e11138/ %U https://doi.org/10.2196/11138 %U http://www.ncbi.nlm.nih.gov/pubmed/30684432 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 8 %P e10398 %T The Influence of Technology Delivery Mode on Intervention Outcomes: Analysis of a Theory-Based Sexual Health Program %A Levitz,Nicole %A Wood,Erica %A Kantor,Leslie %+ Planned Parenthood Federation of America, 123 William Street, New York, NY, 10038, United States, 1 9142623408, nicole.levitz@ppfa.org %K sexual and reproductive health %K public health %K text messaging %K instant messaging %K behavior theory %K internet %D 2018 %7 29.08.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: There are few studies on the role of technology delivery mode on health intervention outcomes. Furthermore, the opportunity to examine potential mode effects on a program that is theory-based and integrates principles of communication and decision-making science to influence sexual and reproductive health outcomes is a new contribution to the literature. Objective: Planned Parenthood Federation of America’s national Chat/Text program can be accessed via short message service (SMS; more commonly referred to as text messaging), Web-based desktop chatting, and mobile phone chatting. The program has been in existence since 2010 and has conducted over 1,000,000 conversations. In this study, we examined whether the mode used to access the program (SMS text, desktop chat, or mobile phone chat) affected program users’ intention to act on the action plan established in their conversation. Methods: Data were examined for a 6-month period from January 2016 to June 2016. The data were collected as a part of the monitoring and evaluation of an ongoing program. We limited our sample to the program’s priority audience of 15-24 years residing within the United States, which resulted in a sample of 64,939 conversations. Available data items for analysis included user demographics, delivery mode, topic discussed, helpfulness rating (on a 4-point scale), user confidence in following through on the intentions made during the conversation (on a 4-point scale), and educator confidence in whether the user would follow through on the stated intention. Linear and multinomial robust regression analyses were conducted to examine the relationships between conversation delivery mode and confidence. Results: No significant relationships between users’ confidence to carry out their intentions and gender or race were found. None of the 3 modalities (SMS text, desktop chat, or mobile phone chat) were significantly associated with user confidence. All the 3 modalities had significant associations with educator confidence and showed similar effect sizes to those of user confidence. Educator confidence was significantly associated with all the topics discussed. Conclusions: The Planned Parenthood Chat/Text program was designed as a tool to improve access to sexual and reproductive health care among young people. The mode of intervention delivery was not associated with users’ confidence in their ability to carry out their stated intention, suggesting that all modes are legitimate for delivering this intervention. Furthermore, each mode worked across gender and race or ethnicity, indicating that this is a modality that can work across groups. %M 30158100 %R 10.2196/10398 %U http://www.jmir.org/2018/8/e10398/ %U https://doi.org/10.2196/10398 %U http://www.ncbi.nlm.nih.gov/pubmed/30158100 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 8 %P e10351 %T Participant Recruitment and Retention in Remote eHealth Intervention Trials: Methods and Lessons Learned From a Large Randomized Controlled Trial of Two Web-Based Smoking Interventions %A Watson,Noreen L %A Mull,Kristin E %A Heffner,Jaimee L %A McClure,Jennifer B %A Bricker,Jonathan B %+ Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, M3-B232, Seattle, WA, 98109, United States, 1 2066672942, nlwatson@fredhutch.org %K recruitment %K retention %K randomized controlled trial %K RCT %K smoking cessation %K web intervention %D 2018 %7 24.08.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite having many advantages, online eHealth trials are not without challenges—notably, participant recruitment, and outcome data retention. Moreover, publications from these trials rarely provide detailed information on the methods used for recruitment and retention or discuss implications of the methods for future studies. Objective: To address this need for empirical guidance regarding recruitment and outcome data retention planning, we aim to describe the methods and lessons learned from the recruitment and retention procedures used in a large randomized trial of 2 Web-based smoking cessation interventions. Methods: To ensure a demographically and geographically diverse participant sample, we used the recruitment strategies (1) traditional, (2) Web-based, and (3) online survey panel methods and adaptively modified each in response to recruitment success. At baseline, participants indicated how they heard about the study and answered demographic questions. To maximize trial retention at each of the 3-, 6-, and 12-month assessment points, 4 survey modalities (first Web, followed by phone, mail, and postcard) were sequentially timed over a 30-day period. Participants received US $25 for submitting their responses, regardless of modality, and received an additional US $10 bonus for completing the Web survey within 24h of electronic notification. Results: We randomized 2637 smokers in 16 months and achieved 88% retention at 12-months. Participants (79.26% female, 72.60% Caucasian) were recruited from all 50 states. The majority of participants were recruited through Facebook (49.43%), followed by the survey panel (20.85%), free internet sources (14.54%), traditional media (11.34%), and Google ads (3.84%). Descriptively, participant demographics varied by recruitment source. Of the completed follow-up surveys, most were completed by Web (92%). Retention rates did not vary by recruitment source. Conclusions: Continuous monitoring and refinement of multiple recruitment methods, particularly of online advertising campaigns, allowed us to maximize the effectiveness of recruitment strategies in recruiting a large, diverse sample of smokers. Likewise, offering multiple follow-up survey modalities in sequential order along with time-dependent bonus incentives enabled us to obtain outcome data from a very high level of enrolled participants for the duration of the trial protocol. These strategies may be similarly useful in other trials. Trial Registration: ClinicalTrials.gov NCT01812278; https://clinicaltrials.gov/ct2/show/NCT01812278 (Archived by WebCite at http://www.webcitation.org/71gy5GLvO) %M 30143479 %R 10.2196/10351 %U http://www.jmir.org/2018/8/e10351/ %U https://doi.org/10.2196/10351 %U http://www.ncbi.nlm.nih.gov/pubmed/30143479 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 8 %P e10003 %T Effect and Process Evaluation of a Smartphone App to Promote an Active Lifestyle in Lower Educated Working Young Adults: Cluster Randomized Controlled Trial %A Simons,Dorien %A De Bourdeaudhuij,Ilse %A Clarys,Peter %A De Cocker,Katrien %A Vandelanotte,Corneel %A Deforche,Benedicte %+ Unit Health Promotion and Education, Department of Public Health, Ghent University, Corneel Heymanslaan 10, Entrance 42 (K3), Ghent, 9000, Belgium, 32 498457442, dorien.simons@ugent.be %K mHealth %K mobile apps %K active transport %K Fitbit %K accelerometers %K mobile phone %K emerging adulthood %K physical activity intervention %K health promotion %D 2018 %7 24.08.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mobile technologies have great potential to promote an active lifestyle in lower educated working young adults, an underresearched target group at a high risk of low activity levels. Objective: The objective of our study was to examine the effect and process evaluation of the newly developed evidence- and theory-based smartphone app “Active Coach” on the objectively measured total daily physical activity; self-reported, context-specific physical activity; and self-reported psychosocial variables among lower educated working young adults. Methods: We recruited 130 lower educated working young adults in this 2-group cluster randomized controlled trial and assessed outcomes at baseline, posttest (baseline+9 weeks), and follow-up (posttest+3 months). Intervention participants (n=60) used the Active Coach app (for 9 weeks) combined with a Fitbit activity tracker. Personal goals, practical tips, and educational facts were provided to encourage physical activity. The control group received print-based generic physical activity information. Both groups wore accelerometers for objective measurement of physical activity, and individual interviews were conducted to assess the psychosocial variables and context-specific physical activity. Furthermore, intervention participants were asked process evaluation questions and generalized linear mixed models and descriptive statistics were applied. Results: No significant intervention effects were found for objectively measured physical activity, self-reported physical activity, and self-reported psychosocial variables (all P>.05). Intervention participants evaluated the Active Coach app and the combined use with the Fitbit wearable as self-explanatory (36/51, 70.6%), user friendly (40/51, 78.4%), and interesting (34/51, 66.7%). Throughout the intervention, we observed a decrease in the frequency of viewing graphical displays in the app (P<.001); reading the tips, facts, and goals (P<.05); and wearing the Fitbit wearable (P<.001). Few intervention participants found the tips and facts motivating (10/41, 24.4%), used them to be physically active (8/41, 19.6%), and thought they were tailored to their lifestyle (7/41, 17.1%). Conclusions: The lack of significant intervention effects might be due to low continuous user engagement. Advice or feedback that was not perceived as adequately tailored and the difficulty to compete with many popular commercial apps on young people’s smartphones may be responsible for a decrease in the engagement. A stand-alone app does not seem sufficient to promote an active lifestyle among lower educated working young adults; therefore, multicomponent interventions (using both technological and human support), as well as context-specific sensing to provide tailored advice, might be needed in this population. Trial Registration: ClinicalTrials.gov NCT02948803; https://clinicaltrials.gov/ct2/show/results/NCT02948803 (Archived by WebCite at http://www.webcitation.org/71OPFwaoA) %M 30143477 %R 10.2196/10003 %U http://mhealth.jmir.org/2018/8/e10003/ %U https://doi.org/10.2196/10003 %U http://www.ncbi.nlm.nih.gov/pubmed/30143477 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 8 %P e255 %T Feasibility and Effects of Digital Interventions to Support People in Recovery From Substance Use Disorders: Systematic Review %A Nesvåg,Sverre %A McKay,James R %+ Centre for Alcohol and Drug Research, Stavanger University Hospital, PO Box 8100, Stavanger,, Norway, 47 908 37 431, ness@sus.no %K digital interventions %K substance use disorders %K recovery support %K feasibility %K effects %D 2018 %7 23.08.2018 %9 Review %J J Med Internet Res %G English %X Background: The development and evaluation of digital interventions aimed at preventing or treating substance use–related problems and disorders is a rapidly growing field. Previous reviews of such interventions reveal a large and complex picture with regard to targeted users, use, and efficacy. Objective: The objective of this review was to investigate the feasibility and effects of interventions developed specifically for digital platforms. These interventions are focused on supporting people in recovery from substance use disorders by helping them achieve their substance use goals and develop a more satisfying life situation. Methods: The review is based on a systematic search in MEDLINE, Embase, PsycInfo, and Cochrane Library databases. Of the 1149 identified articles, 722 were excluded as obviously not relevant. Of the remaining articles, 21 were found to be previous reviews, 269 were on interventions aimed at reducing hazardous alcohol or cannabis use, and 94 were on digitized versions of standard treatment methods. The remaining 43 articles were all read in full and systematically scored by both authors. Results: The 43 articles cover 28 unique interventions, of which 33 have been published after 2013. The interventions are aimed at different target groups (defined by age, substance, or comorbidity). Based on the number of features or modules, the interventions can be categorized as simple or complex. Fourteen of the 18 simple interventions and 9 of the 10 complex interventions have been studied with quantitative controlled methodologies. Thirteen of the 18 simple interventions are integrated in other treatment or support systems, mainly delivered as mobile phone apps, while 6 of the 10 complex interventions are designed as stand-alone interventions, most often delivered on a platform combining desktop/Web and mobile phone technologies. The interventions were generally easy to implement, but in most cases the implementation of the complex interventions was found to be dependent on sustained organizational support. Between 70% and 90% of the participants found the interventions to be useful and easy to use. The rates of sustained use were also generally high, except for simple interventions with an open internet-based recruitment and some information and education modules of the complex interventions. Across all interventions, slightly more than half (55%) of the studies with control groups generated positive findings on 1 or more substance use outcomes, with 57% of the interventions also found to be efficacious in 1 or more studies. In the positive studies, effects were typically in the small to moderate range, with a few studies yielding larger effects. Largely due to the inclusion of stronger control conditions, studies of simple interventions were less likely to produce positive effects. Conclusions: The digital interventions included in this review are in general feasible but are not consistently effective in helping people in recovery from substance use disorder reduce their substance use or achieving other recovery goals. %M 30139724 %R 10.2196/jmir.9873 %U http://www.jmir.org/2018/8/e255/ %U https://doi.org/10.2196/jmir.9873 %U http://www.ncbi.nlm.nih.gov/pubmed/30139724 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 8 %P e244 %T A Web-Based Acceptance-Facilitating Intervention for Identifying Patients' Acceptance, Uptake, and Adherence of Internet- and Mobile-Based Pain Interventions: Randomized Controlled Trial %A Lin,Jiaxi %A Faust,Bianca %A Ebert,David Daniel %A Krämer,Lena %A Baumeister,Harald %+ Institute of Psychology, Department of Clinical Psychology and Psychotherapy, University of Ulm, Albert-Einstein-Allee 47, D Ulm, Ulm, 89069, Germany, 49 07315032800, harald.baumeister@uni-ulm.de %K uptake %K acceptance %K adherence %K eHealth %K chronic pain %K randomized controlled trial %D 2018 %7 21.08.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet- and mobile-based interventions are effective for the treatment of chronic pain. However, little is known about patients’ willingness to engage with these types of interventions and how the uptake of such interventions can be improved. Objective: The aim of this study was to identify people’s acceptance, uptake, and adherence (primary outcomes) with regard to an internet- and mobile-based intervention for chronic pain and the influence of an information video as an acceptance-facilitating intervention (AFI). Methods: In this randomized controlled trial with a parallel design, we invited 489 individuals with chronic pain to participate in a Web-based survey assessing the acceptance of internet- and mobile-based interventions with the offer to receive an unguided internet- and mobile-based intervention for chronic pain after completion. Two versions of the Web-based survey (with and without AFI) were randomly sent to two groups: one with AFI (n=245) and one without AFI (n=244). Participants who completed the Web-based survey with or without AFI entered the intervention group or the control group, respectively. In the survey, the individuals’ acceptance of pain interventions, measured with a 4-item scale (sum score ranging from 4 to 20), predictors of acceptance, sociodemographic and pain-related variables, and physical and emotional functioning were assessed. Uptake rates (log in to the intervention) and adherence (number of completed modules) to the intervention was assessed 4 months after intervention access. To examine which factors influence acceptance, uptake rate, and adherence in the internet- and mobile-based interventions, we conducted additional exploratory subgroup analyses. Results: In total, 57 (intervention group) and 58 (control group) participants in each group completed the survey and were included in the analyses. The groups did not differ with regard to acceptance, uptake rate, or adherence (P=.64, P=.56, P=.75, respectively). Most participants reported moderate (68/115, 59.1%) to high (36/115, 31.3%) acceptance, with 9.6% (11/115) showing low acceptance (intervention group: mean 13.91, SD 3.47; control group: mean 13.61, SD 3.50). Further, 67% (38/57, intervention group) and 62% (36/58, control group) had logged into the intervention. In both groups, an average of 1.04 (SD 1.51) and 1.14 (SD 1.90) modules were completed, respectively. Conclusions: The informational video was not effective with regard to acceptance, uptake rate, or adherence. Despite the high acceptance, the uptake rate was only moderate and adherence was remarkably low. This study shows that acceptance can be much higher in a sample participating in an internet- and mobile-based intervention efficacy trial than in the target population in routine health care settings. Thus, future research should focus not only on acceptance and uptake facilitating interventions but also on ways to influence adherence. Further research should be conducted within routine health care settings with more representative samples of the target population. Trial Registration: German Clinical Trial Registration DRKS00006183; http://www.drks.de/drks_web/navigate.do ?navigationId=trial.HTML&TRIAL_ID=DRKS00006183 (Archived by WebCite at http://www.webcitation.org/70ebHDhne) %M 30131313 %R 10.2196/jmir.9925 %U http://www.jmir.org/2018/8/e244/ %U https://doi.org/10.2196/jmir.9925 %U http://www.ncbi.nlm.nih.gov/pubmed/30131313 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 3 %P e53 %T Digital Characteristics and Dissemination Indicators to Optimize Delivery of Internet-Supported Mindfulness-Based Interventions for People With a Chronic Condition: Systematic Review %A Russell,Lahiru %A Ugalde,Anna %A Milne,Donna %A Austin,David %A Livingston,Patricia M %+ School of Nursing and Midwifery, Deakin University, 11 Gheringhap Street, Geelong, 3220, Australia, 61 392446912, l.russell@deakin.edu.au %K mindfulness %K internet %K chronic condition %D 2018 %7 21.08.2018 %9 Review %J JMIR Ment Health %G English %X Background: Internet-supported mindfulness-based interventions (MBIs) are increasingly being used to support people with a chronic condition. Characteristics of MBIs vary greatly in their mode of delivery, communication patterns, level of facilitator involvement, intervention period, and resource intensity, making it difficult to compare how individual digital features may optimize intervention adherence and outcomes. Objective: The aims of this review were to (1) provide a description of digital characteristics of internet-supported MBIs and examine how these relate to evidence for efficacy and adherence to the intervention and (2) gain insights into the type of information available to inform translation of internet-supported MBIs to applied settings. Methods: MEDLINE Complete, PsycINFO, and CINAHL databases were searched for studies assessing an MBI delivered or accessed via the internet and engaging participants in daily mindfulness-based activities such as mindfulness meditations and informal mindfulness practices. Only studies using a comparison group of alternative interventions (active compactor), usual care, or wait-list were included. Given the broad definition of chronic conditions, specific conditions were not included in the original search to maximize results. The search resulted in 958 articles, from which 11 articles describing 10 interventions met the inclusion criteria. Results: Internet-supported MBIs were more effective than usual care or wait-list groups, and self-guided interventions were as effective as facilitator-guided interventions. Findings were informed mainly by female participants. Adherence to interventions was inconsistently defined and prevented robust comparison between studies. Reporting of factors associated with intervention dissemination, such as population representativeness, program adoption and maintenance, and costs, was rare. Conclusions: More comprehensive descriptions of digital characteristics need to be reported to further our understanding of features that may influence engagement and behavior change and to improve the reproducibility of MBIs. Gender differences in determinants and patterns of health behavior should be taken into account at the intervention design stage to accommodate male and female preferences. Future research could compare MBIs with established evidence-based therapies to identify the population groups that would benefit most from internet-supported programs. Trial Registration: PROSPERO CRD42017078665; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=78665 (Archived by WebCite at http://www.webcitation.org/71ountJpu) %M 30131317 %R 10.2196/mental.9645 %U http://mental.jmir.org/2018/3/e53/ %U https://doi.org/10.2196/mental.9645 %U http://www.ncbi.nlm.nih.gov/pubmed/30131317 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 8 %P e10303 %T Social Media Use in Interventions for Diabetes: Rapid Evidence-Based Review %A Gabarron,Elia %A Årsand,Eirik %A Wynn,Rolf %+ Norwegian Centre for E-health Research, University Hospital of North Norway, Forskningsparken i Breivika 3 etg Sykehusvn 23, Tromso, 9019, Norway, 47 77754030, elia.gabarron@ehealthresearch.no %K social media %K social networking %K health promotion %K intervention studies %K diabetes %D 2018 %7 10.08.2018 %9 Review %J J Med Internet Res %G English %X Background: Health authorities recommend educating diabetic patients and their families and initiating measures aimed at improving self-management, promoting a positive behavior change, and reducing the risk of complications. Social media could provide valid channel to intervene in and deliver diabetes education. However, it is not well known whether the use of these channels in such interventions can help improve the patients’ outcomes. Objective: The objective of our study was to review and describe the current existing evidence on the use of social media in interventions targeting people affected with diabetes. Methods: A search was conducted across 4 databases (PubMed, Scopus, EMBASE, and Cochrane Library).The quality of the evidence of the included primary studies was graded according to the Grading of Recommendations Assessment, Development and Evaluation criteria, and the risk of bias of systematic reviews was assessed by drawing on AMSTAR (A MeaSurement Tool to Assess systematic Reviews) guidelines. The outcomes reported by these studies were extracted and analyzed. Results: We included 20 moderate- and high-quality studies in the review: 17 primary studies and 3 systematic reviews. Of the 16 publications evaluating the effect on glycated hemoglobin (HbA1c) of the interventions using social media, 13 reported significant reductions in HbA1c values. The 5 studies that measured satisfaction with the interventions using social media found positive effects. We found mixed evidence regarding the effect of interventions using social media on health-related quality of life (2 publications found positive effects and 3 found no differences) and on diabetes knowledge or empowerment (2 studies reported improvements and 2 reported no significant changes). Conclusions: There is very little good-quality evidence on the use of social media in interventions aimed at helping people with diabetes. However, the use of these channels is mostly linked to benefits on patients’ outcomes. Public health institutions, clinicians, and other stakeholders who aim at improving the knowledge of diabetic patients could consider the use of social media in their interventions. %M 30097421 %R 10.2196/10303 %U http://www.jmir.org/2018/8/e10303/ %U https://doi.org/10.2196/10303 %U http://www.ncbi.nlm.nih.gov/pubmed/30097421 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 8 %P e10231 %T Differences in the Effect of Internet-Based Cognitive Behavioral Therapy for Improving Nonclinical Depressive Symptoms Among Workers by Time Preference: Randomized Controlled Trial %A Imamura,Kotaro %A Furukawa,Toshi A %A Matsuyama,Yutaka %A Shimazu,Akihito %A Kuribayashi,Kazuto %A Kasai,Kiyoto %A Kawakami,Norito %+ Department of Mental Health, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan, 81 3 5841 3522, nkawakami@m.u-tokyo.ac.jp %K internet-based computerized cognitive behavioral therapy %K time preference %K nonclinical depressive symptoms %K workers %D 2018 %7 10.08.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Previous randomized controlled trials (RCTs) have shown a significant intervention effect of internet-based computerized cognitive behavioral therapy (iCBT) on improving nonclinical depressive symptoms among healthy workers and community residents in a primary prevention setting. Time preference is one’s relative valuation for having a reward (eg, money) at present than at a later date. Time preference may affect the effectiveness of cognitive behavioral therapy. Objective: This RCT aimed to test the difference of intervention effect of an iCBT program on improving nonclinical depressive symptoms between two subgroups classified post-hoc on the basis of time preference among workers in Japan. Methods: All workers in one corporate group (approximate n=20,000) were recruited. Participants who fulfilled the inclusion criteria were randomly allocated to either intervention or control groups. Participants in the intervention group completed 6 weekly lessons and homework assignments within the iCBT program. The Beck Depression Inventory-II (BDI-II) and Kessler’s Psychological Distress Scale (K6) measures were obtained at baseline and 3-, 6-, and 12-month follow-ups. Two subgroups were defined by the median of time preference score at baseline. Results: Only few (835/20,000, 4.2%) workers completed the baseline survey. Of the 835 participants, 706 who fulfilled the inclusion criteria were randomly allocated to the intervention or control group. Participants who selected irrational time preference options were excluded (21 and 18 participants in the intervention and control groups, respectively). A three-way interaction (group [intervention/control] × time [baseline/follow-up] × time preference [higher/lower]) effect of iCBT was significant for BDI-II (t1147.42=2.33, P=.02) and K6 (t1254.04=2.51, P=.01) at the 3-month follow-up, with a greater effect of the iCBT in the group with higher time preference. No significant three-way interaction was found at the 6- and 12-month follow-ups. Conclusions: The effects of the iCBT were greater for the group with higher time preference at the shorter follow-up, but it was leveled off later. Workers with higher time preference may change their cognition or behavior more quickly, but these changes may not persist. Trial Registration: UMIN Clinical Trials Registry UMIN000014146; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000016466 (Archived by WebCite at http://www.webcitation.org/70o2rNk2V) %M 30097419 %R 10.2196/10231 %U http://www.jmir.org/2018/8/e10231/ %U https://doi.org/10.2196/10231 %U http://www.ncbi.nlm.nih.gov/pubmed/30097419 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 8 %P e10012 %T The Effect of Mobile App Interventions on Influencing Healthy Maternal Behavior and Improving Perinatal Health Outcomes: Systematic Review %A Daly,Lisa M %A Horey,Dell %A Middleton,Philippa F %A Boyle,Frances M %A Flenady,Vicki %+ Mater Research Institute, The University of Queensland, Level 3, Aubigny Place, South Brisbane, 4101, Australia, 61 7 3163 5330, lisa.daly@uq.edu.au %K apps %K pregnancy %K perinatal %K maternal %K infant %K mobile %K systematic review %K behavior change %K intervention %D 2018 %7 09.08.2018 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Perinatal morbidity and mortality are significant public health issues with an enduring impact on the health and well-being of women and their families. Millions of pregnant women now download and use mobile applications to access, store, and share health information. However, little is known about the consequences. An investigation of their impact on perinatal health outcomes is particularly topical. Objective: To determine the effects of mobile app interventions during pregnancy on influencing healthy maternal behavior and improving perinatal health outcomes. Methods: Searches of PubMed, Embase, the Cochrane Library, CINAHL, WHO Global Health Library, POPLINE, and CABI Global Health were conducted with no date or language restrictions. Randomized and non-randomized studies were included if they reported perinatal health outcomes of interventions targeting pregnant women, using mobile apps compared with other communication modalities or with standard care. The primary outcome measure was the change in maternal behaviors (as defined by trial authors), by intervention goals. Two reviewers independently extracted data using standardized forms. Results: Four randomized controlled trials (RCTs) involving 456 participants were included. All studies targeted participants in early pregnancy; however, wide variation was evident in participant characteristics, intervention, and study outcomes measures. Three trials were based in hospital settings, comparing women using mobile apps with routine antenatal care. One community-based trial gave all participants a device to promote physical activity; the intervention arm was also given a mobile app. All studies reported data for the primary outcome measure, describing some benefit from the intervention compared with controls. However, few statistically significant primary or secondary outcomes were reported. Due to insufficient data, the planned meta-analysis and subgroup analyses were not performed. Conclusions: Due to limited numbers, heterogeneity of interventions, comparators, and outcome measures, no firm conclusions can be drawn on the effects of mobile application interventions during pregnancy on maternal knowledge, behavior change, and perinatal health outcomes. As millions of women utilize mobile apps during pregnancy, rigorous studies are essential for health care and maternity care providers to optimally design, implement, and evaluate interventions. %M 30093368 %R 10.2196/10012 %U http://mhealth.jmir.org/2018/8/e10012/ %U https://doi.org/10.2196/10012 %U http://www.ncbi.nlm.nih.gov/pubmed/30093368 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 8 %P e10482 %T A Smartphone Game-Based Intervention (Tumaini) to Prevent HIV Among Young Africans: Pilot Randomized Controlled Trial %A Winskell,Kate %A Sabben,Gaëlle %A Akelo,Victor %A Ondeng'e,Ken %A Obong'o,Christopher %A Stephenson,Rob %A Warhol,David %A Mudhune,Victor %+ Rollins School of Public Health, Hubert Department of Global Health, Emory University, 1518 Clifton Road, Atlanta, GA, 30322, United States, 1 (404)727 5286, swinske@emory.edu %K HIV %K youth %K Sub-Saharan Africa %K Kenya %K serious game %K narrative %K smartphone %K pilot study %K randomized controlled trial %K mhealth %K prevention %D 2018 %7 01.08.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: There is a pressing need to ensure that youth in high HIV prevalence settings are prepared for a safer sexual debut. Smartphone ownership is increasing dramatically in low-income and middle-income countries. Smartphone games that are appropriately grounded in behavioral theory and evidence-based practice have the potential to become valuable tools in youth HIV prevention efforts in Sub-Saharan Africa. Objective: To pilot-test a theory-based, empirically grounded smartphone game for young Kenyans designed to increase age and condom use at first sex, aiming to establish directionality of effects on behavior change. Methods: Tumaini (“hope for the future” in Swahili) is an interactive, narrative-based game grounded in social cognitive theory. A randomized controlled pilot study was conducted in Kisumu, Western Kenya, from April to June 2017 with 60 participants aged 11-14 (mean 12.7) years. Intervention arm participants (n=30) were provided with an Android smartphone with Tumaini installed on it and were instructed to play the game for at least 1 hour a day for 16 days; control arm participants (n=30) received no intervention. All participants completed a survey on behavioral mediators, delivered via an audio computer-assisted self-interview system at baseline (T1), post intervention (T2), and at 6 weeks postintervention (T3). The postintervention survey for intervention arm participants included questions eliciting feedback on the game. Intervention arm participants and their parents participated in 8 postintervention focus group discussions. Game log files were analyzed to calculate the length of exposure to the game. Behavioral survey data were analyzed using two-sample t tests to compare mean change from T1 to T2 and to T3 for intervention versus control arm participants. Descriptive statistics on game feedback questions were computed. Focus group transcripts were uploaded to MAXQDA software, where they were labeled with deductive and inductive codes. Data were analyzed thematically and compared across demographics. Results: Intervention arm participants played Tumaini for a mean of approximately 27 hours. The intervention arm showed significant gains in sexual health-related knowledge and self-efficacy (both P<.001), behavioral intention for risk-avoidance strategies and sexual risk communication (P=.006), and overall survey scores (P<.001) compared with the control arm at T3. The postintervention survey revealed high subjective measures of the game’s value, relevance, and appeal. Focus groups identified a wide range of knowledge and skills the participants had gained, including setting goals and planning how to achieve them, which was perceived as a key motivator for avoiding or reducing risk. Conclusions: The study supports the need for further research to assess the efficacy of the game-based intervention. If proven efficacious, smartphone games have the potential to dramatically increase the reach of culturally adapted behavioral interventions while ensuring fidelity to intervention design. Trial Registration: ClinicalTrials.gov NCT03054051; http://clinicaltrials.gov/ct2/show/NCT03054051 (Archived by WebCite at http://www.webcitation.org/70U2gCNtW) %M 30068501 %R 10.2196/10482 %U http://mhealth.jmir.org/2018/8/e10482/ %U https://doi.org/10.2196/10482 %U http://www.ncbi.nlm.nih.gov/pubmed/30068501 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 8 %P e246 %T Blended Smoking Cessation Treatment: Exploring Measurement, Levels, and Predictors of Adherence %A Siemer,Lutz %A Brusse-Keizer,Marjolein GJ %A Postel,Marloes G %A Ben Allouch,Somaya %A Patrinopoulos Bougioukas,Angelos %A Sanderman,Robbert %A Pieterse,Marcel E %+ Research Group Technology, Health & Care, Saxion University of Applied Sciences, MH Tromplaan 28, Enschede, 7513 AB, Netherlands, 31 17678025906, l.siemer@saxion.nl %K blended treatment %K smoking %K adherence %K predictors %K tobacco %K prevention %K cognitive behavioral therapy %D 2018 %7 01.08.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Blended face-to-face and Web-based treatment is a promising way to deliver cognitive behavioral therapy. Since adherence has been shown to be a measure for treatment’s acceptability and a determinant for treatment’s effectiveness, in this study, we explored adherence to a new blended smoking cessation treatment (BSCT). Objective: The objective of our study was to (1) develop an adequate method to measure adherence to BSCT; (2) define an adequate degree of adherence to be used as a threshold for being adherent; (3) estimate adherence to BSCT; and (4) explore the possible predictors of adherence to BSCT. Methods: The data of patients (N=75) were analyzed to trace adherence to BSCT delivered at an outpatient smoking cessation clinic. In total, 18 patient activities (eg, using a Web-based smoking diary tool or responding to counselors’ messages) were selected to measure adherence; the degree of adherence per patient was compared with quitting success. The minimum degree of adherence of patients who reported abstinence was examined to define a threshold for the detection of adherent patients. The number of adherent patients was calculated for each of the 18 selected activities; the degree of adherence over the course of the treatment was displayed; and the number of patients who were adherent was analyzed. The relationship between adherence and 33 person-, smoking-, and health-related characteristics was examined. Results: The method for measuring adherence was found to be adequate as adherence to BSCT correlated with self-reported abstinence (P=.03). Patients reporting abstinence adhered to at least 61% of BSCT. Adherence declined over the course of the treatment; the percentage of adherent patients per treatment activity ranged from 82% at the start of the treatment to 11%-19% at the final-third of BSCT; applying a 61% threshold, 18% of the patients were classified as adherent. Marital status and social modeling were the best independent predictors of adherence. Patients having a partner had 11-times higher odds of being adherent (OR [odds ratio]=11.3; CI: 1.33-98.99; P=.03). For social modeling, graded from 0 (=partner and friends are not smoking) to 8 (=both partner and nearly all friends are smoking), each unit increase was associated with 28% lower odds of being adherent (OR=0.72; CI: 0.55-0.94; P=.02). Conclusions: The current study is the first to explore adherence to a blended face-to-face and Web-based treatment (BSCT) based on a substantial group of patients. It revealed a rather low adherence rate to BSCT. The method for measuring adherence to BSCT could be considered adequate because the expected dose-response relationship between adherence and quitting could be verified. Furthermore, this study revealed that marital status and social modeling were independent predictors of adherence. Trial Registration: Netherlands Trial Registry NTR5113; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5113 (Archived by WebCite at http://www.webcitation.org/71BAPwER8). %M 30068503 %R 10.2196/jmir.9969 %U http://www.jmir.org/2018/8/e246/ %U https://doi.org/10.2196/jmir.9969 %U http://www.ncbi.nlm.nih.gov/pubmed/30068503 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 8 %P e245 %T Effect and Process Evaluation of e-Powered Parents, a Web-Based Support Program for Parents of Children With a Chronic Kidney Disease: Feasibility Randomized Controlled Trial %A Geense,Wytske W %A van Gaal,Betsie GI %A Knoll,Jaqueline L %A Maas,Nienke M %A Kok,Gerjo %A Cornelissen,Elisabeth AM %A Nijhuis-van der Sanden,Maria WG %+ IQ Healthcare, Radboud Institute for Health Science, Radboud University Medical Center, PO Box 9101, 6500 HD, Nijmegen,, Netherlands, 31 24 36 66 868, wytske.geense@radboudumc.nl %K child %K chronic kidney failure %K chronic kidney disease %K effect evaluation %K health promotion %K process evaluation %D 2018 %7 01.08.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Parents of children with chronic kidney disease (CKD) experience high levels of stress in the daily management of their child’s illness. Parents need continuously available support and information, yet online support programs are lacking. e-Powered Parents was developed to fill this gap; it is an online program consisting of (1) medical information, (2) an interactive part, and (3) four training modules (stress management, setting limits, communication, and coping). Prior to a large-scale evaluation, we conducted a feasibility study that consisted of an effect study and a process evaluation. Objective: The objectives of our study were to (1) identify the outcome measures that are most likely to capture the potential benefit, (2) evaluate the potential effectiveness and effect size, and (3) evaluate recruitment, reach, the dose received, and context. Methods: We conducted a feasibility study with a two-armed, wait-list randomized controlled trial (RCT). Prior to baseline, parents (n=146) were randomly allocated to group 1 or group 2. After completing the baseline questionnaire, parents in group 1 were given access to e-Powered Parents, while those in group 2 received usual care. At the 6-month follow-up (T1), all parents received a questionnaire and parents in group 2 were given access to e-Powered Parents as well. After 1.5 years, through an extra measurement (T2), we evaluated the effect of long-term exposure. Outcomes were the child’s quality of life (Child Vulnerability Scale), parental stress (Pediatric Inventory for Parents) and fatigue (Multidimensional Fatigue Inventory), self-efficacy in communication with health care professionals (Perceived Efficacy in Patient-Physician Interactions, PEPPI-5), and parental perceptions of family management (Family Management Measure). Floor and ceiling effects and percentage of parents showing no change in scores were calculated. We used linear mixed models to evaluate the potential effectiveness and effect sizes using the intention-to-treat and per-protocol analyses. In the process evaluation, we evaluated recruitment, reach, the dose received, and context using a questionnaire sent to the parents, log-in data, and a focus group interview with health care professionals. Results: At T1 (n=86) and T2 (n=51), no significant effects were found on any of the five outcomes. The PEPPI-5 showed ceiling effects and high percentages of parents showing no change between the measurement times. The information and interactive part of the intervention were used by 84% (57/68) of the parents in group 1 and 49% (32/65) of the parents in group 2. The information pages were visited most often. Overall, 64% (85/133) of the parents logged in to the training platform and 31% (26/85) actually used the training modules. Conclusions: We did not observe any significant effect on any of the outcomes. This could possibly be explained by the minimal use of the intervention and by parents’ heterogeneity. For continued participation, we recommend a tailored intervention and further studies to find out whether and how online programs could be used to support parents in the management of their child’s CKD. Trial Registration: Netherlands Trial Registry NTR4808; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4808 (Archived by WebCite at http://www.webcitation.org/719rCicvW) %M 30068502 %R 10.2196/jmir.9547 %U http://www.jmir.org/2018/8/e245/ %U https://doi.org/10.2196/jmir.9547 %U http://www.ncbi.nlm.nih.gov/pubmed/30068502 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 7 %P e10756 %T Developing a Digital Marketplace for Family Planning: Pilot Randomized Encouragement Trial %A Green,Eric P %A Augustine,Arun %A Naanyu,Violet %A Hess,Anna-Karin %A Kiwinda,Lulla %+ Duke Global Health Institute, Duke University, Box 90519, Durham, NC, 27708, United States, 1 9196817289, eric.green@duke.edu %K family planning %K unmet need %K contraception %K digital health %K Kenya %D 2018 %7 31.07.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Family planning is an effective tool for preventing death among women who do not want to become pregnant and has been shown to improve newborn health outcomes, advance women’s empowerment, and bring socioeconomic benefits through reductions in fertility and population growth. Yet among the populations that would benefit the most from family planning, uptake remains too low. The emergence of digital health tools has created new opportunities to strengthen health systems and promote behavior change. In this study, women with an unmet need for family planning in Western Kenya were randomized to receive an encouragement to try an automated investigational digital health intervention that promoted the uptake of family planning. Objective: The objectives of the pilot study were to explore the feasibility of a full-scale trial—in particular, the recruitment, encouragement, and follow-up data collection procedures—and to examine the preliminary effect of the intervention on contraception uptake. Methods: This pilot study tested the procedures for a randomized encouragement trial. We recruited 112 women with an unmet need for family planning from local markets in Western Kenya, conducted an eligibility screening, and randomized half of the women to receive an encouragement to try the investigational intervention. Four months after encouraging the treatment group, we conducted a follow-up survey with enrolled participants via short message service (SMS) text message. Results: The encouragement sent via SMS text messages to the treatment group led to differential rates of intervention uptake between the treatment and control groups; however, uptake by the treatment group was lower than anticipated (19/56, 33.9% vs 1/56, 1.8%, in the control group). Study attrition was also substantial. We obtained follow-up data from 44.6% (50/112) of enrolled participants. Among those in the treatment group who tried the intervention, the instrumental variables estimate of the local average treatment effect was an increase in the probability of contraceptive uptake of 41.0 percentage points (95% uncertainty interval −0.03 to 0.85). Conclusions: This randomized encouragement design and study protocol is feasible but requires modifications to the recruitment, encouragement, and follow-up data collection procedures. Trial Registration: ClinicalTrials.gov NCT03224390; https://clinicaltrials.gov/ct2/show/NCT03224390 (Archived by WebCite at http://www.webcitation.org/70yitdJu8) %M 30064968 %R 10.2196/10756 %U http://www.jmir.org/2018/7/e10756/ %U https://doi.org/10.2196/10756 %U http://www.ncbi.nlm.nih.gov/pubmed/30064968 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 2 %N 2 %P e14 %T Web-Based Tailored Intervention to Support Optimal Medication Adherence Among Kidney Transplant Recipients: Pilot Parallel-Group Randomized Controlled Trial %A Côté,José %A Fortin,Marie-Chantal %A Auger,Patricia %A Rouleau,Geneviève %A Dubois,Sylvie %A Boudreau,Nathalie %A Vaillant,Isabelle %A Gélinas-Lemay,Élisabeth %+ Research Centre of the Centre Hospitalier de l’Université de Montréal, 850 St-Denis, Tour St-Antoine, Door S01-128, Montreal, QC, H2X 0A9, Canada, 1 514 890 8000 ext 15536, jose.cote@umontreal.ca %K medication adherence %K transplant recipient %K self-management %K nursing %K Web-based tailored intervention %K randomized controlled trial %D 2018 %7 19.07.2018 %9 Original Paper %J JMIR Formativ Res %G English %X Background: Optimal immunosuppressive medication adherence is essential to graft survival. Transplant-TAVIE is a Web-based tailored intervention developed to promote this adherence. Objective: The objective of our study was to evaluate the Transplant-TAVIE intervention’s acceptability, feasibility, and preliminary efficacy. Methods: In a pilot, parallel-group, randomized controlled trial, we randomly assigned a convenience sample of 70 kidney transplant patients on immunosuppressive medication either to an experimental group (Transplant-TAVIE) or to a control group (existing websites). Kidney transplant recipients had to be older than 18 years, be taking immunosuppressant medication, and have access to the internet to participate in this study. Transplant-TAVIE was composed of three interactive Web-based sessions hosted by a virtual nurse. We documented user appreciation of and exposure to the intervention. Furthermore, we assessed medication adherence, medication self-efficacy, intake-related skills, and medication side effects at baseline and 3 and 6 months later. Analyses of variance were used to assess intergroup differences over time. Results: After baseline questionnaire completion, participants were randomly assigned either to Transplant-TAVIE (n=35) or to the websites (n=35) group. All participants had received their kidney graft <1 year to 32 years earlier (mean 6.8 years). Of the experimental group, 54% (19/35) completed the sessions of Transplant-TAVIE. Users found the intervention to be acceptable—33% were extremely satisfied (6/18), 39% were very satisfied (7/18), and 28% were satisfied (5/18). At baseline and over time, both experimental and control groups reported high medication adherence, high medication self-efficacy, and frequent use of skills related to medication intake. No intergroup differences emerged over time. Conclusions: The results of this study support the feasibility and acceptability of Transplant-TAVIE. It could constitute an accessible adjunct in support of existing specialized services. %M 30684400 %R 10.2196/formative.9707 %U http://formative.jmir.org/2018/2/e14/ %U https://doi.org/10.2196/formative.9707 %U http://www.ncbi.nlm.nih.gov/pubmed/30684400 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 7 %P e10017 %T Effectiveness of a Blended Care Self-Management Program for Caregivers of People With Early-Stage Dementia (Partner in Balance): Randomized Controlled Trial %A Boots,Lizzy MM %A de Vugt,Marjolein E %A Kempen,Gertrudis IJM %A Verhey,Frans RJ %+ Alzheimer Center Limburg, Department of Psychiatry and Neuropsychology, School for Mental Health and Neurosciences, Maastricht University Medical Center, PO Box 616, Maastricht, 6200 MD, Netherlands, 31 43 3881994, l.boots@maastrichtuniversity.nl %K internet %K caregivers %K technology %K therapeutics %D 2018 %7 13.07.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: The benefits of electronic health support for dementia caregivers are increasingly recognized. Reaching caregivers of people with early-stage dementia could prevent high levels of burden and psychological problems in the later stages. Objective: The current study evaluates the effectiveness of the blended care self-management program, Partner in Balance, compared to a control group. Methods: A single-blind randomized controlled trial with 81 family caregivers of community-dwelling people with mild dementia was conducted. Participants were randomly assigned to either the 8-week, blended care self-management Partner in Balance program (N=41) or a waiting-list control group (N=40) receiving usual care (low-frequent counseling). The program combines face-to-face coaching with tailored Web-based modules. Data were collected at baseline and after 8 weeks in writing by an independent research assistant who was blinded to the treatment. The primary proximal outcome was self-efficacy (Caregiver Self-Efficacy Scale) and the primary distal outcome was symptoms of depression (Center for Epidemiological Studies Depression Scale). Secondary outcomes included mastery (Pearlin Mastery Scale), quality of life (Investigation Choice Experiments for the Preferences of Older People), and psychological complaints (Hospital Anxiety and Depression Scale-Anxiety and Perceived Stress Scale). Results: A significant increase in favor of the intervention group was demonstrated for self-efficacy (care management, P=.002; service use P=.001), mastery (P=.001), and quality of life (P=.032). Effect sizes were medium for quality of life (d=0.58) and high for self-efficacy care management and service use (d=0.85 and d=0.93, respectively) and mastery (d=0.94). No significant differences between the groups were found on depressive symptoms, anxiety, and perceived stress. Conclusions: This study evaluated the first blended-care intervention for caregivers of people with early-stage dementia and demonstrated a significant improvement in self-efficacy, mastery, and quality of life after receiving the Partner in Balance intervention, compared to a waiting-list control group receiving care as usual. Contrary to our expectations, the intervention did not decrease symptoms of depression, anxiety, or perceived stress. However, the levels of psychological complaints were relatively low in the study sample. Future studies including long-term follow up could clarify if an increase in self-efficacy results in a decrease or prevention of increased stress and depression. To conclude, the program can provide accessible preventative care to future generations of caregivers of people with early-stage dementia. Trial Registration: Netherlands Trial Register NTR4748; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4748 (Archived by WebCite at http://www.webcitation.org/6vSb2t9Mg) %M 30006327 %R 10.2196/10017 %U http://www.jmir.org/2018/7/e10017/ %U https://doi.org/10.2196/10017 %U http://www.ncbi.nlm.nih.gov/pubmed/30006327 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 5 %N 3 %P e23 %T A Text Message–Based Intervention Targeting Alcohol Consumption Among University Students: User Satisfaction and Acceptability Study %A Müssener,Ulrika %A Thomas,Kristin %A Linderoth,Catharina %A Leijon,Matti %A Bendtsen,Marcus %+ Department of Medical and Health Sciences, Linköping University, Linköping, Sweden, S-58183, Sweden, 46 732702426, ulrika.mussener@liu.se %K students %K text messages %K mobile phones %K SMS %K alcohol consumption intervention %D 2018 %7 10.07.2018 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Heavy consumption of alcohol among university students is a global problem, with excessive drinking being the social norm. Students can be a difficult target group to reach, and only a minority seek alcohol-related support. It is important to develop interventions that can reach university students in a way that does not further stretch the resources of the health services. Text messaging (short message service, SMS)–based interventions can enable continuous, real-time, cost-effective, brief support in a real-world setting, but there is a limited amount of evidence for effective interventions on alcohol consumption among young people based on text messaging. To address this, a text messaging–based alcohol consumption intervention, the Amadeus 3 intervention, was developed. Objective: This study explored self-reported changes in drinking habits in an intervention group and a control group. Additionally, user satisfaction among the intervention group and the experience of being allocated to a control group were explored. Methods: Students allocated to the intervention group (n=460) were asked about their drinking habits and offered the opportunity to give their opinion on the structure and content of the intervention. Students in the control group (n=436) were asked about their drinking habits and their experience in being allocated to the control group. Participants received an email containing an electronic link to a short questionnaire. Descriptive analyses of the distribution of the responses to the 12 questions for the intervention group and 5 questions for the control group were performed. Results: The response rate for the user feedback questionnaire of the intervention group was 38% (176/460) and of the control group was 30% (129/436). The variation in the content of the text messages from facts to motivational and practical advice was appreciated by 77% (135/176) participants, and 55% (97/176) found the number of messages per week to be adequate. Overall, 81% (142/176) participants stated that they had read all or nearly all the messages, and 52% (91/176) participants stated that they were drinking less, and increased awareness regarding negative consequences was expressed as the main reason for reduced alcohol consumption. Among the participants in the control group, 40% (52/129) stated that it did not matter that they had to wait for access to the intervention. Regarding actions taken while waiting for access, 48% (62/129) participants claimed that they continued to drink as before, whereas 35% (45/129) tried to reduce their consumption without any support. Conclusions: Although the main randomized controlled trial was not able to detect a statistically significant effect of the intervention, most participants in this qualitative follow-up study stated that participation in the study helped them reflect upon their consumption, leading to altered drinking habits and reduced alcohol consumption. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN95054707; http://www.isrctn.com/ISRCTN95054707 (Archived by WebCite at http://www.webcitation.org/705putNZT) %M 29991469 %R 10.2196/humanfactors.9641 %U http://humanfactors.jmir.org/2018/3/e23/ %U https://doi.org/10.2196/humanfactors.9641 %U http://www.ncbi.nlm.nih.gov/pubmed/29991469 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 5 %N 2 %P e13 %T Users’ Perspectives, Opportunities, and Barriers of the Strengthen Your Ankle App for Evidence-Based Ankle Sprain Prevention: Mixed-Methods Process Evaluation for a Randomized Controlled Trial %A van Reijen,Miriam %A Asscheman,Marianne %A Vriend,Ingrid %A van Mechelen,Willem %A Verhagen,Evert %+ Amsterdam Collaboration on Health and Safety in Sports, Department of Public & Occupational Health, Amsterdam Public Health Research Institute, VU University Medical Centre, Amsterdam, Van der Boechorststraat 7, Amsterdam, 1081BT, Netherlands, 31 204449691, e.verhagen@vumc.nl %K injury prevention %K ankle injury %K eHealth %K qualitative analysis %K process evaluation %D 2018 %7 06.07.2018 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: The “Strengthen Your Ankle” neuromuscular training program has been thoroughly studied over the past 8 years. This process evaluation is a part of a randomized controlled trial that examined both the short- and long-term effectiveness of this particular program. Although it was shown previously that the program, available both in a printed booklet and as a mobile app, is able to effectively reduce the number of recurrent ankle sprains, participants’ compliance with the program is an ongoing challenge. Objective: This process evaluation explored participants’ opinions regarding both the methods of delivery, using RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) Framework to identify barriers and challenges to program compliance. Although Reach, Effectiveness, and Adaptation were the focus of a previous study, this paper focuses on the implementation and maintenance phases. Methods: Semistructured interviews and online questionnaires were analyzed using qualitative content analysis. Fisher exact, chi-square, and t tests assessed between-group differences in quantitative survey responses. Interviews were assessed by thematic analysis to identify key themes. Results: While there were no significant differences in the perceived simplicity, usefulness, and liking of the exercise during the 8 weeks of the neuromuscular training program, semistructured interviews showed that 14 of 16 participants agreed that an app would be of additional benefits over a booklet. After the 12-month follow-up, when asked how they evaluated the overall use of the app or the booklet, the users of the app gave a mean score of 7.7 (SD 0.99) versus a mean score 7.1 (SD 1.23) for the users of the booklet. This difference in mean score was significant (P=.006). Conclusions: Although both the app and booklet showed a high user satisfaction, the users of the app were significantly more satisfied. Semistructured questionnaires allowed users to address issues they would like to improve in future updates. Including a possibility for feedback and postponement of exercises, an explanation of the use of specific exercises and possibly music were identified as features that might further improve the contentment of the program, probably leading to increased compliance. Trial Registration: Netherlands Trial Register NTR4027; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4027 (Archived by Webcite at http://www.webcitation.org/70MTo9dMV) %M 29980497 %R 10.2196/rehab.8638 %U http://rehab.jmir.org/2018/2/e13/ %U https://doi.org/10.2196/rehab.8638 %U http://www.ncbi.nlm.nih.gov/pubmed/29980497 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 7 %P e237 %T Determinants of Successful eHealth Coaching for Consumer Lifestyle Changes: Qualitative Interview Study Among Health Care Professionals %A Brandt,Carl Joakim %A Søgaard,Gabrielle Isidora %A Clemensen,Jane %A Søndergaard,Jens %A Nielsen,Jesper Bo %+ Research Unit of General Practice, Department of Public Health, University of Southern Denmark, JB Winsløwsvej 9A, Odense C, 5000, Denmark, 45 20141566, cbrandt@health.sdu.dk %K behavior change %K eHealth coaching %K empathy %K lifestyle %K healthy lifestyle %K mHealth %K mobile health units %K primary health care %K primary care %K public health %K relationship %K telemedicine %D 2018 %7 5.7.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Success with lifestyle change, such as weight loss, tobacco cessation, and increased activity level, using electronic health (eHealth) has been demonstrated in numerous studies short term. However, evidence on how to maintain the effect long-term has not been fully explored, even though there is a pressing need for long-term solutions. Recent studies indicate that weight loss can be achieved and maintained over 12 and 20 months in a primary care setting using a collaborative eHealth tool. The effect of collaborative eHealth in promoting lifestyle changes depends on competent and skilled dieticians, nurses, physiotherapists, and occupational therapists acting as eHealth coaches. How such health care professionals perceive delivering asynchronous eHealth coaching and which determinants they find to be essential to achieving successful long-term lifestyle coaching have only been briefly explored and deserve further exploration. Objective: The aim of this study is to analyze how health care professionals perceive eHealth coaching and to explore what influences successful long-term lifestyle change for patients undergoing hybrid eHealth coaching using a collaborative eHealth tool. Methods: A total of 10 health care professionals were recruited by purposive sampling. They were all women aged 36 to 65 years of age with a mean age of 48 years of age. A total of 8/10 (80%) had more than 15 years of experience in their field, and all had more than six months of experience providing eHealth lifestyle coaching using a combination of face-to-face meetings and asynchronous eHealth coaching. They worked in 5 municipalities in the Region of Southern Denmark. We performed individual, qualitative, semistructured, in-depth interviews in their workplace about their experiences with health coaching about lifestyle change, both for their patients and for themselves, and mainly how they perceived using a collaborative eHealth solution as a part of their work. Results: The health care professionals all found establishing and maintaining an empathic relationship essential and that asynchronous eHealth lifestyle coaching challenged this compared to face-to-face coaching. The primary reason was that unlike typical in-person encounters in health care, they did not receive immediate feedback from the patients. We identified four central themes relevant to the health care professionals in their asynchronous eHealth coaching: (1) establishing an empathic relationship, (2) reflection in asynchronous eHealth coaching, (3) identifying realistic goals based on personal barriers, and (4) staying connected in asynchronous coaching. Conclusions: Establishing and maintaining an empathic relationship is probably the most crucial factor for successful subsequent eHealth coaching. It was of paramount importance to get to know the patient first, and the asynchronous interaction aspect presented challenges because of the delay in response times (both ways). It also presented opportunities for reflection before answering. The health care professionals found they had to provide both relational communication and goal-oriented coaching when using eHealth solutions. Going forward, the quality of the health care professional–patient interaction will need attention if patients are to benefit from collaborative eHealth coaching fully. %R 10.2196/jmir.9791 %U http://www.jmir.org/2018/7/e237/ %U https://doi.org/10.2196/jmir.9791 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 7 %P e234 %T Large-Scale Dissemination of Internet-Based Cognitive Behavioral Therapy for Youth Anxiety: Feasibility and Acceptability Study %A March,Sonja %A Spence,Susan H %A Donovan,Caroline L %A Kenardy,Justin A %+ Institute for Resilient Regions, University of Southern Queensland, Sinnathamby Blvd, Springfield, QLD, 4300, Australia, 61 34704434, sonja.march@usq.edu.au %K adolescent %K child %K anxiety disorders %K cognitive behavioral therapy %K eHealth %K public health %D 2018 %7 04.07.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-based cognitive behavioral therapy (iCBT) for child and adolescent anxiety has demonstrated efficacy in randomized controlled trials, but it has not yet been examined when disseminated as a public health intervention. If effective, iCBT programs could be a promising first-step, low-intensity intervention that can be easily accessed by young people. Objective: The objective of our study was to examine the feasibility and acceptability of a publicly available online, self-help iCBT program (BRAVE Self-Help) through exploration of program adherence, satisfaction, and changes in anxiety. Methods: This study was an open trial involving the analysis of data collected from 4425 children and adolescents aged 7-17 years who presented with elevated anxiety at registration (baseline) for the iCBT program that was delivered through an open-access portal with no professional support. We assessed the program satisfaction via a satisfaction scale and measured adherence via the number of completed sessions. In addition, anxiety severity was assessed via scores on the Children’s Anxiety Scale, 8-item (CAS-8) at four time points: baseline, Session 4, Session 7, and Session 10. Results: Participants reported moderate satisfaction with the program and 30% completed three or more sessions. Statistically significant reductions in anxiety were evident across all time points for both children and adolescents. For users who completed six or more sessions, there was an average 4-point improvement in CAS-8 scores (Cohen d=0.87, children; Cohen d=0.81, adolescents), indicating a moderate to large effect size. Among participants who completed nine sessions, 57.7% (94/163) achieved recovery into nonelevated levels of anxiety and 54.6% (89/163) achieved statistically reliable reductions in anxiety. Conclusions: Participant feedback was positive, and the program was acceptable to most young people. Furthermore, significant and meaningful reductions in anxiety symptoms were achieved by many children and adolescents participating in this completely open-access and self-directed iCBT program. Our results suggest that online self-help CBT may offer a feasible and acceptable first step for service delivery to children and adolescents with anxiety. %M 29973338 %R 10.2196/jmir.9211 %U http://www.jmir.org/2018/7/e234/ %U https://doi.org/10.2196/jmir.9211 %U http://www.ncbi.nlm.nih.gov/pubmed/29973338 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 7 %P e232 %T Traditional and Web-Based Technologies to Improve Partner Notification Following Syphilis Diagnosis Among Men Who Have Sex With Men in Lima, Peru: Pilot Randomized Controlled Trial %A Clark,Jesse L %A Segura,Eddy R %A Oldenburg,Catherine E %A Salvatierra,Hector J %A Rios,Jessica %A Perez-Brumer,Amaya Gabriela %A Gonzales,Pedro %A Sheoran,Bhupendra %A Sanchez,Jorge %A Lama,Javier R %+ David Geffen School of Medicine, Division of Infectious Diseases, Department of Medicine, University of California, Los Angeles, 10833 Leconte Avenue, CHS 37-121, Los Angeles, CA, 90095, United States, 1 310 825 3543, jlclark@mednet.ucla.edu %K infectious diseases %K syphilis %K partner notification %K men who have sex with men %K Latin America %D 2018 %7 03.07.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Patient-initiated partner notification (PN) following the diagnosis of a sexually transmitted infection is a critical component of disease control in men who have sex with men (MSM) sexual networks. Both printed and internet-based technologies offer potential tools to enhance traditional partner notification approaches among MSM in resource-limited settings. Objective: This randomized controlled trial aimed to evaluate the effect of 2 different PN technologies on notification outcomes following syphilis diagnosis among MSM in Peru: a Web-based notification system and patient-delivered partner referral cards. Methods: During 2012-2014, we screened 1625 MSM from Lima, Peru, for syphilis infection and enrolled 370 MSM with symptomatic primary or secondary syphilis (n=58) or asymptomatic latent syphilis diagnosed by serology (rapid plasma reagin, RPR, and Microhemagglutination assay for Treponema pallidum antibody; n=312). Prior to enrollment, potential participants used a computer-based self-interviewing system to enumerate their recent sexual partnerships and provide details of their 3 most recent partners. Eligible participants were randomly assigned to one of 4 intervention arms: (1) counseling and patient-initiated Web-based PN (n=95), (2) counseling with Web-based partner notification and partner referral cards (n=84), (3) counseling and partner referral cards (n=97), and (4) simple partner notification counseling (control; n=94). Self-reported partner notification was assessed after 14 days among 354 participants who returned for the follow-up assessment. Results: The median age of enrolled participants was 27 (interquartile range, IQR 23-34) years, with a median of 2 partners (IQR 1-5) reported in the past month. Compared with those who received only counseling (arm 4), MSM provided with access to Web-based partner notification (arms 1 and 2) or printed partner referral cards (arms 2 and 3) were more likely to have notified one or more of their sexual partners (odds ratio, OR, 2.18, 95% CI 1.30-3.66; P=.003 and OR 1.68, 95% CI 1.01-2.79; P=.045, respectively). The proportion of partners notified was also higher in both Web-based partner notification (241/421, 57.2%; P<.001) and referral card (240/467, 51.4%; P=.006) arms than in the control arm (82/232, 35.3%). Conclusions: Both new Web-based technologies and traditional printed materials support patient-directed notification and improve self-reported outcomes among MSM with syphilis. Additional research is needed to refine the use of these partner notification tools in specific partnership contexts. Trial Registration: ClinicalTrials.gov NCT01720641; https://clinicaltrials.gov/ct2/show/NCT01720641 (Archived by WebCite at http://www.webcitation.org/70A89rJL4) %M 29970355 %R 10.2196/jmir.9821 %U http://www.jmir.org/2018/7/e232/ %U https://doi.org/10.2196/jmir.9821 %U http://www.ncbi.nlm.nih.gov/pubmed/29970355 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 7 %P e10668 %T Impact of Internet-Based Interventions on Caregiver Mental Health: Systematic Review and Meta-Analysis %A Sherifali,Diana %A Ali,Muhammad Usman %A Ploeg,Jenny %A Markle-Reid,Maureen %A Valaitis,Ruta %A Bartholomew,Amy %A Fitzpatrick-Lewis,Donna %A McAiney,Carrie %+ School of Nursing, Faculty of Health Sciences, McMaster University, HSC 3N28F, 1280 Main Street West, Hamilton, ON,, Canada, 1 905 525 9140 ext 21435, dsherif@mcmaster.ca %K internet %K support %K education %K mental health %K caregivers %K chronic conditions %D 2018 %7 03.07.2018 %9 Review %J J Med Internet Res %G English %X Background: The health of informal caregivers of adults with chronic conditions is increasingly vital since caregivers comprise a large proportion of supportive care to family members living in the community. Due to efficiency and reach, internet-based interventions for informal caregivers have the potential to mitigate the negative mental health outcomes associated with caregiving. Objective: The objective of this systematic review and meta-analysis was to examine the impact of internet-based interventions on caregiver mental health outcomes and the impact of different types of internet-based intervention programs. Methods: MEDLINE, EMBASE, CINAHL, PsycINFO, Cochrane, and AgeLine databases were searched for randomized controlled trials or controlled clinical trials published from January 1995 to April 2017 that compared internet-based intervention programs with no or minimal internet-based interventions for caregivers of adults with at least 1 chronic condition. The inclusion criteria were studies that included (1) adult informal caregivers (aged 18 years or older) of adults living in the community with a chronic condition; (2) an internet-based intervention program to deliver education, support, or monitoring to informal caregivers; and (3) outcomes of mental health. Title and abstract and full-text screening were completed in duplicate. Data were extracted by a single reviewer and verified by a second reviewer, and risk of bias assessments were completed accordingly. Where possible, data for mental health outcomes were meta-analyzed. Results: The search yielded 7923 unique citations of which 290 studies were screened at full-text. Of those, 13 studies met the inclusion criteria; 11 were randomized controlled trials, 1 study was a controlled clinical trial, and 1 study comprised both study designs. Beneficial effects of any internet-based intervention program resulted in a mean decrease of 0.48 points (95% CI –0.75 to –0.22) for stress and distress and a mean decrease of 0.40 points (95% CI –0.58 to –0.22) for anxiety among caregivers. For studies that examined internet-based information and education plus professional psychosocial support, the meta-analysis results showed small to medium beneficial effect sizes of the intervention for the mental health outcomes of depression (–0.34; 95% CI –0.63 to –0.05) and anxiety (–0.36; 95% CI –0.66 to –0.07). Some suggestion of a beneficial effect on overall health for the use of information and education plus combined peer and professional support was also shown (1.25; 95% CI 0.24 to 2.25). Overall, many studies were of poor quality and were rated at high risk of bias. Conclusions: The review found evidence for the benefit of internet-based intervention programs on mental health for caregivers of adults living with a chronic condition, particularly for the outcomes of caregiver depression, stress and distress, and anxiety. The types of interventions that predominated as efficacious included information and education with or without professional psychological support, and, to a lesser extent, with combined peer and psychological support. Further high-quality research is needed to inform the effectiveness of interactive, dynamic, and multicomponent internet-based interventions. Trial Registration: PROSPERO CRD42017075436; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=75436 (Archived by WebCite at http://www.webcitation.org/709M3tDvn) %M 29970358 %R 10.2196/10668 %U http://www.jmir.org/2018/7/e10668/ %U https://doi.org/10.2196/10668 %U http://www.ncbi.nlm.nih.gov/pubmed/29970358 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 6 %P e10484 %T Web-Based Intervention for Family Carers of Persons with Dementia and Multiple Chronic Conditions (My Tools 4 Care): Pragmatic Randomized Controlled Trial %A Duggleby,Wendy %A Ploeg,Jenny %A McAiney,Carrie %A Peacock,Shelley %A Fisher,Kathryn %A Ghosh,Sunita %A Markle-Reid,Maureen %A Swindle,Jennifer %A Williams,Allison %A Triscott,Jean AC %A Forbes,Dorothy %A Jovel Ruiz,Kathya %+ Faculty of Nursing, University of Alberta, Level 3, ECHA, 11405 87 Avenue, Edmonton, AB, T6G 1C9, Canada, 1 780 492 6764, wendy.duggleby@ualberta.ca %K carers %K dementia %K treatment %K internet %D 2018 %7 29.06.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: My Tools 4 Care (MT4C) is a Web-based intervention that was developed based on the transitions theory. It is an interactive, self-administered, and portable toolkit containing six main sections intended to support carers of community-living persons with Alzheimer’s disease and related dementia and multiple chronic conditions through their transition experiences. Objective: The objective of our study was to evaluate the effectiveness of MT4C with respect to increasing hope, self-efficacy, and health-related quality of life in carers of community-living older persons with Alzheimer’s disease and related dementia and multiple chronic conditions. Methods: A multisite, pragmatic, mixed methods, longitudinal, repeated-measures, randomized controlled trial was conducted between June 2015 and April 2017. Eligible participants were randomized into either treatment (MT4C) or educational control groups. Following baseline measures, carers in the treatment group received 3 months of password-protected access to MT4C. Trained research assistants collected data from participants via phone on hope (Herth Hope Index [HHI]), self-efficacy (General Self-Efficacy Scale), and health-related quality of life (Short Form-12 item [version 2] health survey; SF-12v2) at baseline, 1, 3, and 6 months. The use and cost of health and social services (Health and Social Services Utilization Inventory) among participants were measured at baseline, 3, and 6 months. Analysis of covariance was used to identify group differences at 3 months, and generalized estimating equations were used to identify group differences over time. Results: A total of 199 carers participated in this study, with 101 participants in the treatment group and 98 in the educational control group. Of all, 23% (45/199) participants withdrew during the study for various reasons, including institutionalization or death of the person with dementia and lack of time from the carer. In the treatment group, 73% (74/101) carers used MT4C at least once over the 3-month period. No significant differences in the primary outcome measure (mental component summary score from the SF-12v2) by group or time were noted at 3 months; however, significant differences were evident for HHI-factor 2 (P=.01), with higher hope scores in the treatment group than in the control group. General estimating equations showed no statistically significant group differences in terms of mental component summary score at all time points. Attrition and the fact that not all carers in the treatment group used MT4C may explain the absence of statistically significant results for the main outcome variable. Conclusions: Despite no significant differences between groups in terms of the primary outcome variable (mental component score), the significant differences in terms of one of the hope factors suggest that MT4C had a positive influence on the lives of participants. Trial Registration: ClinicalTrials.gov NCT02428387; https://clinicaltrials.gov/ct2/show/NCT02428387 (Archived by Webcite at http://www.webcitation.org/708oFCR8h). %M 29959111 %R 10.2196/10484 %U http://www.jmir.org/2018/6/e10484/ %U https://doi.org/10.2196/10484 %U http://www.ncbi.nlm.nih.gov/pubmed/29959111 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 6 %P e10457 %T An Online Hand Exercise Intervention for Adults With Rheumatoid Arthritis (mySARAH): Design, Development, and Usability Testing %A Srikesavan,Cynthia %A Williamson,Esther %A Cranston,Tim %A Hunter,John %A Adams,Jo %A Lamb,Sarah E %+ Rehabilitation Research in Oxford, Nuffield Department of Orthopedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Windmill Road, Oxford, OX3 7LD, United Kingdom, 44 01865737907, cynthia.srikesavan@ndorms.ox.ac.uk %K rheumatoid arthritis %K hand joints %K exercise training %K web-based %D 2018 %7 27.06.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: The Strengthening and Stretching for Rheumatoid Arthritis of the Hand (SARAH) program is a tailored, progressive 12-week exercise program for people with hand problems due to rheumatoid arthritis. The program was shown to be clinically and cost-effective in a large clinical trial and is recommended by the UK National Institute for Health and Care Excellence (NICE) guidelines for rheumatoid arthritis in adults. Objective: We have developed an online version of the SARAH program (mySARAH) to make the SARAH program widely accessible to people with rheumatoid arthritis. The purposes of this study were to develop mySARAH and to evaluate and address its usability issues. Methods: We developed mySARAH using a three-step process and gaining feedback from patient contributors. After initial development, mySARAH was tested in two iterative usability cycles in nine participants using a simplified think-aloud protocol and self-reported questionnaires. We also evaluated if participants executed the SARAH exercises correctly after watching the exercise videos included on the website. Results: A preliminary version of mySARAH consisting of six sessions over a 12-week period and delivered via text, exercise videos, images, exercise plan form, exercise calendar, and links to additional information on rheumatoid arthritis was developed. Five participants (1 male; 4 females; median age 64 years) and four participants (four females; median age 64.5 years) took part in the first and second usability testing cycles respectively. Usability issues identified from Cycle 1 such as having a navigation tutorial video and individualised feedback on pain levels were addressed prior to Cycle 2. The need for more instructions to complete the mySARAH patient forms was identified in Cycle 2 and was rectified. Self-reports from both cycles indicated that participants found the program useful and easy to use and were confident in performing the SARAH exercises themselves. Eight of the nine participants correctly demonstrated all the exercises. Conclusions: mySARAH is the first online hand exercise intervention for people with rheumatoid arthritis. We actively involved target users in the development and usability evaluation and ensured mySARAH met their needs and preferences. %M 29950288 %R 10.2196/10457 %U http://www.jmir.org/2018/6/e10457/ %U https://doi.org/10.2196/10457 %U http://www.ncbi.nlm.nih.gov/pubmed/29950288 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 6 %P e146 %T Effectiveness of a Text Messaging–Based Intervention Targeting Alcohol Consumption Among University Students: Randomized Controlled Trial %A Thomas,Kristin %A Müssener,Ulrika %A Linderoth,Catharina %A Karlsson,Nadine %A Bendtsen,Preben %A Bendtsen,Marcus %+ Division of Community Medicine, Department of Medical and Health Sciences, Linköping University, Linköping, 58183, Sweden, 46 733140708, marcus.bendtsen@liu.se %K alcohol consumption intervention %K text message-based intervention %K university students %K brief intervention %D 2018 %7 25.06.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Excessive drinking among university students is a global challenge, leading to significant health risks. However, heavy drinking among students is widely accepted and socially normalized. Mobile phone interventions have attempted to reach students who engage in excessive drinking. A growing number of studies suggest that text message–based interventions could potentially reach many students and, if effective, such an intervention might help reduce heavy drinking in the student community. Objective: The objective of this study was to test the effectiveness of a behavior change theory–based 6-week text message intervention among university students. Methods: This study was a two-arm, randomized controlled trial with an intervention group receiving a 6-week text message intervention and a control group that was referred to treatment as usual at the local student health care center. Outcome measures were collected at baseline and at 3 months after the initial invitation to participate in the intervention. The primary outcome was total weekly alcohol consumption. Secondary outcomes were frequency of heavy episodic drinking, highest estimated blood alcohol concentration, and number of negative consequences attributable to excessive drinking. Results: A total of 896 students were randomized to either the intervention or control group. The primary outcome analysis included 92.0% of the participants in the intervention group and 90.1% of the control group. At follow-up, total weekly alcohol consumption decreased in both groups, but no significant between-group difference was seen. Data on the secondary outcomes included 49.1% of the participants in the intervention group and 41.3% of the control group. No significant between-group difference was seen for any of the secondary outcomes. Conclusions: The present study was under-powered, which could partly explain the lack of significance. However, the intervention, although theory-based, needs to be re-assessed and refined to better support the target group. Apart from establishing which content forms an effective intervention, the optimal length of an alcohol intervention targeting students also needs to be addressed in future studies. Trial Registration: International Standard Randomised Controlled Trial Number ISRCTN95054707; http://www.isrctn.com/ISRCTN95054707 (Archived by WebCite at http://www.webcitation.org/70Ax4vXhd) %M 29941417 %R 10.2196/mhealth.9642 %U http://mhealth.jmir.org/2018/6/e146/ %U https://doi.org/10.2196/mhealth.9642 %U http://www.ncbi.nlm.nih.gov/pubmed/29941417 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 6 %P e207 %T Evaluation of a Diabetes Self-Management Program: Claims Analysis on Comorbid Illnesses, Health Care Utilization, and Cost %A Turner,Ralph M %A Ma,Qinli %A Lorig,Kate %A Greenberg,Jay %A DeVries,Andrea R %+ HealthCore, Inc, 123 Justison Street, Wilmington, DE, 19801, United States, 1 302 230 2000, qma@healthcore.com %K diabetes mellitus %K patient education %K health care utilization %K cost %D 2018 %7 22.06.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: An estimated 30.3 million Americans have diabetes mellitus. The US Department of Health and Human Services created national objectives via its Healthy People 2020 initiative to improve the quality of life for people who either have or are at risk for diabetes mellitus, and hence, lower the personal and national economic burden of this debilitating chronic disease. Diabetes self-management education interventions are a primary focus of this initiative. Objective: The aim of this study was to evaluate the impact of the Better Choices Better Health Diabetes (BCBH-D) self-management program on comorbid illness related to diabetes mellitus, health care utilization, and cost. Methods: A propensity score matched two-group, pre-post design was used for this study. Retrospective administrative medical and pharmacy claims data from the HealthCore Integrated Research Environment were used for outcome variables. The intervention cohort included diabetes mellitus patients who were recruited to a diabetes self-management program. Control cohort subjects were identified from the HealthCore Integrated Research Environment by at least two diabetes-associated claims (International Classification of Diseases-Ninth Revision, ICD-9 250.xx) within 2 years before the program launch date (October 1, 2011-September 30, 2013) but did not participate in BCBH-D. Controls were matched to cases in a 3:1 propensity score match. Outcome measures included pre- and postintervention all-cause and diabetes-related utilization and costs. Cost outcomes are reported as least squares means. Repeated measures analyses (generalized estimating equation approach) were conducted for utilization, comorbid conditions, and costs. Results: The program participants who were identified in HealthCore Integrated Research Environment claims (N=558) were matched to a control cohort of 1669 patients. Following the intervention, the self-management cohort experienced significant reductions for diabetes mellitus–associated comorbid conditions, with the postintervention disease burden being significantly lower (mean 1.6 [SD 1.6]) compared with the control cohort (mean 2.1 [SD 1.7]; P=.001). Postintervention all-cause utilization was decreased in the intervention cohort compared with controls with −40/1000 emergency department visits vs +70/1000; P=.004 and −5780 outpatient visits per 1000 vs −290/1000; P=.001. Unadjusted total all-cause medical cost was decreased by US $2207 in the intervention cohort compared with a US $338 decrease in the controls; P=.001. After adjustment for other variables through structural equation analysis, the direct effect of the BCBH-D was –US $815 (P=.049). Conclusions: Patients in the BCBH-D program experienced reduced all-cause health care utilization and costs. Direct cost savings were US $815. Although encouraging, given the complexity of the patient population, further study is needed to cross-validate the results. %M 29934284 %R 10.2196/jmir.9225 %U http://www.jmir.org/2018/6/e207/ %U https://doi.org/10.2196/jmir.9225 %U http://www.ncbi.nlm.nih.gov/pubmed/29934284 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 6 %P e213 %T The Effectiveness of Web-Based Tailored Smoking Cessation Interventions on the Quitting Process (Project Quit): Secondary Analysis of a Randomized Controlled Trial %A Chakraborty,Bibhas %A Maiti,Raju %A Strecher,Victor J %+ Centre for Quantitative Medicine, Duke-NUS Medical School, Academia, Level 6, 20 College Road, Singapore, 169856, Singapore, 65 6576 7377, bibhas.chakraborty@duke-nus.edu.sg %K smoking cessation %K number of quit attempts %K tailored intervention %K treatment regimen %K Web-based intervention %D 2018 %7 20.06.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Project Quit was a randomized Web-based smoking cessation trial designed and conducted by researchers from the University of Michigan, where its primary outcome was the 7-day point prevalence. One drawback of such an outcome is that it only focuses on smoking behavior over a very short duration, rather than the quitting process over the entire study period. Objective: The aim of this study was to consider the number of quit attempts during the 6-month study period as an alternative outcome, which would better reflect the quitting process. We aimed to find out whether tailored interventions (high vs low) are better in reducing the number of quit attempts for specific subgroups of smokers. Methods: To identify interactions between intervention components of smoking cessation and individual smoker characteristics, we employed Poisson regression to analyze the number of quit attempts. This approach allowed us to construct data-driven, personalized interventions. Results: A negative effect of the number of cigarettes smoked per day (P=.03) and a positive effect of education (P=.03) on the number of quit attempts were detected from the baseline covariates (n=792). Thus, for every 10 extra cigarettes smoked per day, there was a 5.84% decrease in the expected number of quit attempts. Highly educated participants had a 15.49% increase in their expected number of quit attempts compared with their low-educated counterparts. A negative interaction between intervention component story and smoker’s education was also detected (P=.03), suggesting that a high-tailored story given to highly educated people results in 13.50% decrease in the number of quit attempts compared with a low-tailored story. Conclusions: A highly individually tailored story is significantly more effective for smokers with a low level of education. This is consistent with prior findings from Project Quit based on the 7-day point prevalence. %M 29925494 %R 10.2196/jmir.9555 %U http://www.jmir.org/2018/6/e213/ %U https://doi.org/10.2196/jmir.9555 %U http://www.ncbi.nlm.nih.gov/pubmed/29925494 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 6 %P e10528 %T Multicomponent mHealth Intervention for Large, Sustained Change in Multiple Diet and Activity Risk Behaviors: The Make Better Choices 2 Randomized Controlled Trial %A Spring,Bonnie %A Pellegrini,Christine %A McFadden,H G %A Pfammatter,Angela Fidler %A Stump,Tammy K %A Siddique,Juned %A King,Abby C %A Hedeker,Donald %+ Feinberg School of Medicine, Northwestern University, Department of Preventive Medicine, 680 N Lakeshore Drive, Suite 1400, Chicago, IL, 60611, United States, 1 312 503 6579, bspring@northwestern.edu %K health behavior %K risk factors %K mobile health %K behavioral medicine %K randomized controlled trial %D 2018 %7 19.06.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Prevalent co-occurring poor diet and physical inactivity convey chronic disease risk to the population. Large magnitude behavior change can improve behaviors to recommended levels, but multiple behavior change interventions produce small, poorly maintained effects. Objective: The Make Better Choices 2 trial tested whether a multicomponent intervention integrating mHealth, modest incentives, and remote coaching could sustainably improve diet and activity. Methods: Between 2012 and 2014, the 9-month randomized controlled trial enrolled 212 Chicago area adults with low fruit and vegetable and high saturated fat intakes, low moderate to vigorous physical activity (MVPA) and high sedentary leisure screen time. Participants were recruited by advertisements to an open-access website, screened, and randomly assigned to either of two active interventions targeting MVPA simultaneously with, or sequentially after other diet and activity targets (N=84 per intervention) or a stress and sleep contact control intervention (N=44). They used a smartphone app and accelerometer to track targeted behaviors and received personalized remote coaching from trained paraprofessionals. Perfect behavioral adherence was rewarded with an incentive of US $5 per week for 12 weeks. Diet and activity behaviors were measured at baseline, 3, 6, and 9 months; primary outcome was 9-month diet and activity composite improvement. Results: Both simultaneous and sequential interventions produced large, sustained improvements exceeding control (P<.001), and brought all diet and activity behaviors to guideline levels. At 9 months, the interventions increased fruits and vegetables by 6.5 servings per day (95% CI 6.1-6.8), increased MVPA by 24.7 minutes per day (95% CI 20.0-29.5), decreased sedentary leisure by 170.5 minutes per day (95% CI –183.5 to –157.5), and decreased saturated fat intake by 3.6% (95% CI –4.1 to –3.1). Retention through 9-month follow-up was 82.1%. Self-monitoring decreased from 96.3% of days at baseline to 72.3% at 3 months, 63.5% at 6 months, and 54.6% at 9 months (P<.001). Neither attrition nor decline in self-monitoring differed across intervention groups. Conclusions: Multicomponent mHealth diet and activity intervention involving connected coaching and modest initial performance incentives holds potential to reduce chronic disease risk. Trial Registration: ClinicalTrials.gov NCT01249989; https://clinicaltrials.gov/ct2/show/NCT01249989 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT01249989). %M 29921561 %R 10.2196/10528 %U http://www.jmir.org/2018/6/e10528/ %U https://doi.org/10.2196/10528 %U http://www.ncbi.nlm.nih.gov/pubmed/29921561 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 6 %P e211 %T Severely Burdened Individuals Do Not Need to Be Excluded From Internet-Based and Mobile-Based Stress Management: Effect Modifiers of Treatment Outcomes From Three Randomized Controlled Trials %A Weisel,Kiona Krueger %A Lehr,Dirk %A Heber,Elena %A Zarski,Anna-Carlotta %A Berking,Matthias %A Riper,Heleen %A Ebert,David Daniel %+ Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University Erlangen-Nuernberg, 4th Floor, Nägelsbachstraße 25a, Erlangen, 91052, Germany, 49 091318567570, kiona.weisel@fau.de %K anxiety %K depression %K internet %K effect modifier %K randomized controlled trials %K occupational stress %D 2018 %7 19.06.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Although internet-based and mobile-based stress management interventions (iSMIs) may be a promising strategy to reach employees suffering from high chronic stress, it remains unknown whether participants with high symptom severity of depression or anxiety also benefit from iSMIs or should be excluded. Objective: This study aimed to evaluate the efficacy of iSMIs in subgroups with high symptom severity and to test whether baseline symptom severity moderates treatment outcome. Methods: Data from three randomized controlled trials (N=791) were pooled to identify effect modifiers and to evaluate efficacy in subgroups with different levels of initial symptom severity. The outcomes perceived stress (Perceived Stress Scale, PSS), depression severity (Center for Epidemiological Depression Scale, CES-D), and anxiety (Hospital Anxiety and Depression Scale, HADS) symptom severity were assessed at baseline, 7-week postassessment, and 6-month follow-up. Potential moderators were tested in predicting differences in the change of outcome in multiple moderation analyses. Simple slope analyses evaluated efficacy of the iSMI comparing the intervention group with the waitlist control group in subgroups with low, moderate, and severe initial symptomology based on means and SDs of the study population. In addition, subgroups with clinical values of depression (CES-D≥16) and anxiety (HADS≥8) at baseline were explored, and response rates (RRs; 50% symptom reduction) and symptom-free (SF) status (CES-D<16, HADS<8) were reported. Results: Individuals with high stress (PSS≥30), depression (CES-D≥33), anxiety (HADS≥15), and emotional exhaustion (MBI≥5.6) benefited significantly from the intervention with great reductions of stress (dpost=0.86-1.16, dFU=0.93-1.35), depression (dpost=0.69-1.08, dFU=0.91-1.19), and anxiety (dpost=0.79-1.19, dFU=1.06-1.21), and effects were sustained at 6-month follow-up. Symptom severity moderated treatment outcomes, as individuals with higher symptom severity at baseline benefited significantly more from the intervention than individuals with lower symptom severity. Furthermore, 82.9% (656/791) of individuals had clinical depression values at baseline, of which significantly more individuals in the intervention group reached at least 50% symptom reduction or fell under clinical cut-off (RR: 29.2%, 93/318; SF: 39.6%, 126/318) compared with the waitlist control group (RR: 8.0%, 27/338; SF: 18.6%, 63/338) at postassessment. Significantly more individuals with clinical anxiety values at baseline (HADS≥8, 85.3%, 675/791) in the intervention group achieved at least 50% symptom reduction or fell under clinical cut-off (RR: 27.7%, 94/339; SF: 39.8%, 135/339) compared with the WLC (RR: 4.8%, 16/336; SF: 15.5%, 52/336). Conclusions: Highly burdened individuals benefit greatly from iSMIs and therefore should not be excluded from participation. Stress management may be a valid entry point to reach highly burdened individuals who otherwise may not seek treatment. Trial Registration: 1) German Clinical Trials Register DRKS00005112; https://www.drks.de/DRKS00005112 (Archived by WebCite at http://www.webcitation.org/6zmIZwvdA); 2) German Clinical Trials Register DRKS00005384; https://www.drks.de/ DRKS00005384 (Archived by WebCite at http://www.webcitation.org/6zmIerdtr); and 3) German Clinical Trials Register DRKS00004749; https://www.drks.de/DRKS00004749 (Archived by WebCite at http://www.webcitation.org/6zmIjDQPx). %M 29921562 %R 10.2196/jmir.9387 %U http://www.jmir.org/2018/6/e211/ %U https://doi.org/10.2196/jmir.9387 %U http://www.ncbi.nlm.nih.gov/pubmed/29921562 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 6 %P e96 %T Effect Evaluation of a Web-Based Coaching Intervention to Support Implementation of Sex Education Among Secondary School Teachers: Randomized Controlled Trial %A Schutte,Lisette %A Mevissen,Fraukje E.F %A Meijer,Suzanne %A Paulussen,Theo %A van Empelen,Pepijn %A Kok,Gerjo %+ Department of Work and Social Psychology, Maastricht University, PO Box 616, 6200 MD, Maastricht, 6200 MD, Netherlands, 31 433881908, lisette.schutte@maastrichtuniversity.nl %K sex education %K randomized controlled trial %K coaching %K secondary schools %D 2018 %7 18.06.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: The quality of implementation is important to ensure the effectiveness of behavioral change interventions in practice. Implementing such programs with completeness and adherence is not an automatic process and may require additional support. In school settings, the support teachers receive during implementation is often limited and appears to fall short when attempting to preserve completeness and adherence in program delivery. With the aim to improve completeness and adherence of teachers’ delivery of a sexual health promoting intervention (“Long Live Love” [LLL]) in secondary education, a Web-based e-coach was developed (“lesgevenindeliefde.nl”or“teachinglove.nl”). The effectiveness of the e-coach, as part of a broader implementation strategy, in influencing teachers’ implementation was evaluated. Objective: This study aimed to report on the effect evaluation to determine the effect of the Web-based e-coach on teacher implementation of a school-based sex education program called LLL and on its determinants. Methods: A cluster randomized controlled trial (e-coaching vs waiting list control) was conducted with a baseline assessment (T0) and follow-up (T1) 2 weeks after completing the LLL program. A total of 43 schools with 83 teachers participated in the study. In the follow-up, 38 schools participated, 23 in the e-coaching condition with 41 teachers and 15 in the control condition with 26 teachers. Multilevel regression analysis was used to evaluate the effect of the e-coaching website on implementation behavior, namely, completeness and adherence to LLL implementation, and on its determinants. Results: The e-coaching intervention was not found to have an effect on teachers’ implementation behavior; teachers assigned to the experimental e-coaching website did not score higher on completeness (P=.60) or adherence (P=.67) as compared with teachers in the control condition. When comparing the 30 teachers who made actual use of the e-coaching website with the 37 teachers who did not, no significant differences were found either (P≥.54). In addition, there was no effect of e-coaching on the determinants of teacher implementation behavior (t67-75≤0.69; P≥.22). Conclusions: E-coaching was not found to be effective in enhancing completeness of and adherence to LLL by teachers. The lack of effect may be attributed to the intervention content, the limited use, or the study design itself. The e-coaching intervention may not have adequately addressed adherence and completeness of LLL to bring about behavioral change. Furthermore, the e-coaching intervention was not or insufficiently used by teachers. A possible biased sample of motivated, able teachers may have agreed to participate in the study, and a possible “ceiling effect” may have been present because of the high implementation grade. This, however, does not imply that Web-based coaching in itself is an ineffective strategy to promote adherence and completeness of program implementation. A process evaluation is required as follow-up. Trial Registration: International Standard Randomised Controlled Trial Number ISRCTN11754581; http://www.isrctn.com/ISRCTN11754581 (Archived by WebCite at http://www.webcitation.org/70C5TUOOh) %M 29734139 %R 10.2196/jmir.7053 %U http://www.jmir.org/2018/6/e96/ %U https://doi.org/10.2196/jmir.7053 %U http://www.ncbi.nlm.nih.gov/pubmed/29734139 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 6 %P e216 %T Internet-Based Interventions Aimed at Supporting Family Caregivers of People With Dementia: Systematic Review %A Hopwood,Jenny %A Walker,Nina %A McDonagh,Lorraine %A Rait,Greta %A Walters,Kate %A Iliffe,Stephen %A Ross,Jamie %A Davies,Nathan %+ Centre for Ageing Population Studies, Research Department of Primary Care and Population Health, University College London, Rowland Hill Street, Royal Free Hospital, London, NW3 2PF, United Kingdom, 44 2077940500 ext 34141, n.m.davies@ucl.ac.uk %K dementia %K caregivers %K internet %K review %D 2018 %7 12.06.2018 %9 Review %J J Med Internet Res %G English %X Background: Caring for someone with dementia is one of the most challenging caring roles. The need for support for family caregivers has been recognized for some time but is often still lacking. With an aging population, demand on health and social care services is growing, and the population is increasingly looking to the internet for information and support. Objective: In this review, we aimed to (1) identify the key components of existing internet-based interventions designed to support family caregivers of people with dementia, (2) develop an understanding of which components are most valued by caregivers, and (3) consider the evidence of effectiveness of internet-based interventions designed to support family caregivers of people with dementia. Methods: We conducted a systematic search of online databases in April 2018. We searched reference lists and tracked citations. All study designs were included. We adopted a narrative synthesis approach with thematic analysis and tabulation as tools. Results: We identified 2325 studies, of which we included 40. The interventions varied in the number and types of components, duration and dose, and outcomes used to measure effectiveness. The interventions focused on (1) contact with health or social care providers, (2) peer interaction, (3) provision of information, (4) decision support, and (5) psychological support. The overall quality of the studies was low, making interpretation and generalizability of the effectiveness findings difficult. However, most studies suggested that interventions may be beneficial to family caregiver well-being, including positive impacts on depression, anxiety, and burden. Particular benefit came from psychological support provided online, where several small randomized controlled trials suggested improvements in caregiver mental health. Provision of information online was most beneficial when tailored specifically for the individual and used as part of a multicomponent intervention. Peer support provided in online groups was appreciated by most participants and showed positive effects on stress. Finally, online contact with a professional was appreciated by caregivers, who valued easy access to personalized practical advice and emotional support, leading to a reduction in burden and strain. Conclusions: Although mixed, the results indicate a positive response for the use of internet-based interventions by caregivers. More high-quality studies are required to identify the effectiveness of internet interventions aimed at supporting family caregivers, with particular focus on meeting the needs of caregivers during the different stages of dementia. %M 29895512 %R 10.2196/jmir.9548 %U http://www.jmir.org/2018/6/e216/ %U https://doi.org/10.2196/jmir.9548 %U http://www.ncbi.nlm.nih.gov/pubmed/29895512 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 6 %P e201 %T Cost-Effectiveness of Facilitated Access to a Self-Management Website, Compared to Usual Care, for Patients With Type 2 Diabetes (HeLP-Diabetes): Randomized Controlled Trial %A Li,Jinshuo %A Parrott,Steve %A Sweeting,Michael %A Farmer,Andrew %A Ross,Jamie %A Dack,Charlotte %A Pal,Kingshuk %A Yardley,Lucy %A Barnard,Maria %A Hudda,Mohammed %A Alkhaldi,Ghadah %A Murray,Elizabeth %+ Research Department of Primary Care and Population Health, University College London, London, NW3 2PF, United Kingdom, 44 2077940500 ext 38826, elizabeth.murray@ucl.ac.uk %K cost-effectiveness %K type 2 diabetes mellitus %K self-management %K internet %D 2018 %7 08.06.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Type 2 diabetes mellitus is one of the most common long-term conditions, and costs health services approximately 10% of their total budget. Active self-management by patients improves outcomes and reduces health service costs. While the existing evidence suggested that uptake of self-management education was low, the development of internet-based technology might improve the situation. Objective: To establish the cost-effectiveness of a Web-based self-management program for people with type 2 diabetes (HeLP-Diabetes) compared to usual care. Methods: An incremental cost-effectiveness analysis was conducted, from a National Health Service and personal and social services perspective, based on data collected from a multi-center, two-arm individually randomized controlled trial over 12 months. Adults aged 18 or over with a diagnosis of type 2 diabetes and registered with the 21 participating general practices (primary care) in England, UK, were approached. People who were unable to provide informed consent or to use the intervention, terminally ill, or currently participating in a trial of an alternative self-management intervention, were excluded. The participants were then randomized to either usual care plus HeLP-Diabetes, an interactive, theoretically-informed Web-based self-management program, or to usual care plus access to a comparator website containing basic information only. The participants’ intervention costs and wider health care resource use were collected as well as two health-related quality of life measures: the Problem Areas in Diabetes (PAID) Scale and EQ-5D-3L. EQ-5D-3L was then used to calculate quality-adjusted life years (QALYs). The primary analysis was based on intention-to-treat, using multiple imputation to handle the missing data. Results: In total, 374 participants were randomized, with 185 in the intervention group and 189 in the control group. The primary analysis showed incremental cost-effectiveness ratios of £58 (95% CI –411 to 587) per unit improvement on PAID scale and £5550 (95% CI –21,077 to 52,356) per QALY gained by HeLP-Diabetes, compared to the control. The complete case analysis showed less cost-effectiveness and higher uncertainty with incremental cost-effectiveness ratios of £116 (95% CI –1299 to 1690) per unit improvement on PAID scale and £18,500 (95% CI –203,949 to 190,267) per QALY. The cost-effectiveness acceptability curve showed an 87% probability of cost-effectiveness at £20,000 per QALY willingness-to-pay threshold. The one-way sensitivity analyses estimated 363 users would be needed to use the intervention for it to become less costly than usual care. Conclusions: Facilitated access to HeLP-Diabetes is cost-effective, compared to usual care, under the recommended threshold of £20,000 to £30,000 per QALY by National Institute of Health and Care Excellence. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 02123133; http://www.controlled-trials.com/ISRCTN02123133 (Archived by WebCite at http://www.webcitation.org/6zqjhmn00) %M 29884608 %R 10.2196/jmir.9256 %U http://www.jmir.org/2018/6/e201/ %U https://doi.org/10.2196/jmir.9256 %U http://www.ncbi.nlm.nih.gov/pubmed/29884608 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 6 %P e167 %T Online Lifestyle Modification Intervention: Survey of Primary Care Providers’ Attitudes and Views %A Hanna,Reem M %A Fischer,Gary %A Conroy,Molly B %A Bryce,Cindy %A Hess,Rachel %A McTigue,Kathleen %+ Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh, PA, 15213, United States, 1 412 692 4843, kmm34@pitt.edu %K online intervention %K obesity %K health information technology %K referral model %D 2018 %7 08.06.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Online tools are a convenient and effective method of delivering lifestyle interventions to obese adult primary care patients. A referral model allows physicians to efficiently direct their patients to the intervention during a primary care visit. However, little is known of physicians’ perspectives and utilization of the referral model for an online lifestyle modification intervention. Objective: The aim was to evaluate the response of primary care providers (PCPs) to a referral model for implementing a year-long online intervention for weight loss to obese adult patients. Methods: The PCPs at six primary care clinics were asked to refer adult obese patients to a year-long online lifestyle intervention providing self-management support for weight loss. Following the 1-year intervention, all providers at the participating practices were surveyed regarding their views of the program. Respondents completed survey items assessing their attitudes regarding the 1-year intensive weight loss intervention and identifying resources they would find helpful for assisting patients with weight loss. Referring physicians were asked about their level of satisfaction with implementing the counseling services using standard electronic health record referral processes. Attitudes toward obesity counseling among referring and nonreferring providers were compared. Impressions of how smoothly the referral model of obesity treatment integrated with the clinical workflow were also quantified. Results: Of the 67 providers who completed the surveys, nonreferring providers (n=17) were more likely to prefer counseling themselves (P=.04) and to report having sufficient time to do so (P=.03) than referring providers (n=50) were. Nonreferring providers were more likely to report that their patients lacked computer skills (76%, 13/17 vs 34%, 17/50) or had less access to the Internet (65%, 11/17 vs 32%, 16/50). Conclusions: Understanding providers’ views and barriers regarding the integration of online tools will facilitate widespread implementation of an online lifestyle modification intervention. %M 29884605 %R 10.2196/jmir.8616 %U http://www.jmir.org/2018/6/e167/ %U https://doi.org/10.2196/jmir.8616 %U http://www.ncbi.nlm.nih.gov/pubmed/29884605 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 6 %P e199 %T Beyond the Trial: Systematic Review of Real-World Uptake and Engagement With Digital Self-Help Interventions for Depression, Low Mood, or Anxiety %A Fleming,Theresa %A Bavin,Lynda %A Lucassen,Mathijs %A Stasiak,Karolina %A Hopkins,Sarah %A Merry,Sally %+ Faculty of Health, Victoria University of Wellington, Kelburn Parade, Wellington,, New Zealand, 64 800 842 8888, terry.fleming@vuw.ac.nz %K e-therapy %K mobile applications %K eHealth %K depression %K anxiety %D 2018 %7 06.06.2018 %9 Review %J J Med Internet Res %G English %X Background: Digital self-help interventions (including online or computerized programs and apps) for common mental health issues have been shown to be appealing, engaging, and efficacious in randomized controlled trials. They show potential for improving access to therapy and improving population mental health. However, their use in the real world, ie, as implemented (disseminated) outside of research settings, may differ from that reported in trials, and implementation data are seldom reported. Objective: This study aimed to review peer-reviewed articles reporting user uptake and/or ongoing use, retention, or completion data (hereafter usage data or, for brevity, engagement) from implemented pure self-help (unguided) digital interventions for depression, anxiety, or the enhancement of mood. Methods: We conducted a systematic search of the Scopus, Embase, MEDLINE, and PsychINFO databases for studies reporting user uptake and/or usage data from implemented digital self-help interventions for the treatment or prevention of depression or anxiety, or the enhancement of mood, from 2002 to 2017. Additionally, we screened the reference lists of included articles, citations of these articles, and the titles of articles published in Internet Interventions, Journal of Medical Internet Research (JMIR), and JMIR Mental Health since their inception. We extracted data indicating the number of registrations or downloads and usage of interventions. Results: After the removal of duplicates, 970 papers were identified, of which 10 met the inclusion criteria. Hand searching identified 1 additional article. The included articles reported on 7 publicly available interventions. There was little consistency in the measures reported. The number of registrants or downloads ranged widely, from 8 to over 40,000 per month. From 21% to 88% of users engaged in at least minimal use (eg, used the intervention at least once or completed one module or assessment), whereas 7-42% engaged in moderate use (completing between 40% and 60% of modular fixed-length programs or continuing to use apps after 4 weeks). Indications of completion or sustained use (completion of all modules or the last assessment or continuing to use apps after six weeks or more) varied from 0.5% to 28.6%. Conclusions: Available data suggest that uptake and engagement vary widely among the handful of implemented digital self-help apps and programs that have reported this, and that usage may vary from that reported in trials. Implementation data should be routinely gathered and reported to facilitate improved uptake and engagement, arguably among the major challenges in digital health. %R 10.2196/jmir.9275 %U http://www.jmir.org/2018/6/e199/ %U https://doi.org/10.2196/jmir.9275 %0 Journal Article %@ 2291-9694 %I JMIR Publications %V 6 %N 2 %P e37 %T Development and Validation of a Functional Behavioural Assessment Ontology to Support Behavioural Health Interventions %A Merlo,Gianluca %A Chiazzese,Giuseppe %A Taibi,Davide %A Chifari,Antonella %+ Istituto per le Tecnologie Didattiche, Consiglio Nazionale delle Ricerche, Via Ugo La Malfa 153, Palermo, 90146, Italy, 39 0916809207, gianluca.merlo@itd.cnr.it %K ontology %K behavioral interventions %K functional behavioral assessment %K eHealth care %K evidence-based practice %D 2018 %7 31.05.2018 %9 Original Paper %J JMIR Med Inform %G English %X Background: In the cognitive-behavioral approach, Functional Behavioural Assessment is one of the most effective methods to identify the variables that determine a problem behavior. In this context, the use of modern technologies can encourage the collection and sharing of behavioral patterns, effective intervention strategies, and statistical evidence about antecedents and consequences of clusters of problem behaviors, encouraging the designing of function-based interventions. Objective: The paper describes the development and validation process used to design a specific Functional Behavioural Assessment Ontology (FBA-Ontology). The FBA-Ontology is a semantic representation of the variables that intervene in a behavioral observation process, facilitating the systematic collection of behavioral data, the consequential planning of treatment strategies and, indirectly, the scientific advancement in this field of study. Methods: The ontology has been developed deducing concepts and relationships of the ontology from a gold standard and then performing a machine-based validation and a human-based assessment to validate the Functional Behavioural Assessment Ontology. These validation and verification processes were aimed to verify how much the ontology is conceptually well founded and semantically and syntactically correct. Results: The Pellet reasoner checked the logical consistency and the integrity of classes and properties defined in the ontology, not detecting any violation of constraints in the ontology definition. To assess whether the ontology definition is coherent with the knowledge domain, human evaluation of the ontology was performed asking 84 people to fill in a questionnaire composed by 13 questions assessing concepts, relations between concepts, and concepts’ attributes. The response rate for the survey was 29/84 (34.52%). The domain experts confirmed that the concepts, the attributes, and the relationships between concepts defined in the FBA-Ontology are valid and well represent the Functional Behavioural Assessment process. Conclusions: The new ontology developed could be a useful tool to design new evidence-based systems in the Behavioral Interventions practices, encouraging the link with other Linked Open Data datasets and repositories to provide users with new models of eHealth focused on the management of problem behaviors. Therefore, new research is needed to develop and implement innovative strategies to improve the poor reproducibility and translatability of basic research findings in the field of behavioral assessment. %R 10.2196/medinform.7799 %U http://medinform.jmir.org/2018/2/e37/ %U https://doi.org/10.2196/medinform.7799 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 5 %P e10662 %T A Mobile App for Identifying Individuals With Undiagnosed Diabetes and Prediabetes and for Promoting Behavior Change: 2-Year Prospective Study %A Leung,Angela YM %A Xu,Xin Yi %A Chau,Pui Hing %A Yu,Yee Tak Esther %A Cheung,Mike KT %A Wong,Carlos KH %A Fong,Daniel YT %A Wong,Janet YH %A Lam,Cindy LK %+ Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, GH528, 5th Floor, Core G, School of Nursing, Hung Hom, Kowloon, Hong Kong SAR,, China (Hong Kong), 852 27665587, angela.ym.leung@polyu.edu.hk %K diabetes mellitus %K prediabetes %K prediabetic state %K mobile apps %K lifestyle %D 2018 %7 24.05.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: To decrease the burden of diabetes in society, early screening of undiagnosed diabetes and prediabetes is needed. Integrating a diabetes risk score into a mobile app would provide a useful platform to enable people to self-assess their risk of diabetes with ease. Objective: The objectives of this study were to (1) assess the profile of Diabetes Risk Score mobile app users, (2) determine the optimal cutoff value of the Finnish Diabetes Risk Score to identify undiagnosed diabetes and prediabetes in the Chinese population, (3) estimate users’ chance of developing diabetes within 2 years of using the app, and (4) investigate high-risk app users’ lifestyle behavior changes after ascertaining their risk level from the app. Methods: We conducted this 2-phase study among adults via mobile app and online survey from August 2014 to December 2016. Phase 1 adopted a cross-sectional design, with a descriptive analysis of the app users’ profile. We used a Cohen kappa score to show the agreement between the risk level (as shown in the app) and glycated hemoglobin test results. We used sensitivity, specificity, and area under the curve to determine the optimal cutoff value of the diabetes risk score in this population. Phase 2 was a prospective cohort study. We used a logistic regression model to estimate the chance of developing diabetes after using the app. Paired t tests compared high-risk app users’ lifestyle changes. Results: A total of 13,289 people used the app in phase 1a. After data cleaning, we considered 4549 of these as valid data. Most users were male, and 1811 (39.81%) had tertiary education or above. Among them, 188 (10.4%) users agreed to attend the health assessment in phase 1b. We recommend the optimal value of the diabetes risk score for identifying persons with undiagnosed diabetes and prediabetes to be 9, with an area under the receiver operating characteristic curve of 0.67 (95% CI 0.60-0.74), sensitivity of 0.70 (95% CI 0.58-0.80), and specificity of 0.57 (95% CI 0.47-0.66). At the 2-year follow-up, people in the high-risk group had a higher chance of developing diabetes (odds ratio 4.59, P=.048) than the low-risk group. The high-risk app users improved their daily intake of vegetables (baseline: mean 0.76, SD 0.43; follow-up: mean 0.93, SD 0.26; t81=–3.77, P<.001) and daily exercise (baseline: mean 0.40, SD 0.49; follow-up: mean 0.54, SD 0.50; t81=–2.08, P=.04). Conclusions: The Diabetes Risk Score app has been shown to be a feasible and reliable tool to identify persons with undiagnosed diabetes and prediabetes and to predict diabetes incidence in 2 years. The app can also encourage high-risk people to modify dietary habits and reduce sedentary lifestyle. %M 29793901 %R 10.2196/10662 %U http://mhealth.jmir.org/2018/5/e10662/ %U https://doi.org/10.2196/10662 %U http://www.ncbi.nlm.nih.gov/pubmed/29793901 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 5 %P e106 %T Applicability of a Web-Based, Individualized Exercise Intervention in Patients With Liver Disease, Cystic Fibrosis, Esophageal Cancer, and Psychiatric Disorders: Process Evaluation of 4 Ongoing Clinical Trials %A Pfirrmann,Daniel %A Haller,Nils %A Huber,Yvonne %A Jung,Patrick %A Lieb,Klaus %A Gockel,Ines %A Poplawska,Krystyna %A Schattenberg,Jörn Markus %A Simon,Perikles %+ Department of Sports Medicine, Disease Prevention and Rehabilitation, Institute of Sports Science, Johannes Gutenberg University, , Mainz,, Germany, 49 6131 39 23 586, simonpe@uni-mainz.de %K esophageal cancer %K cystic fibrosis %K depression %K nonalcoholic fatty liver disease %K exercise %K eHealth %D 2018 %7 22.05.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: In the primary and secondary prevention of civilization diseases, regular physical activity is recommended in international guidelines to improve disease-related symptoms, delay the progression of the disease, or to enhance postoperative outcomes. In the preoperative context, there has been a paradigm shift in favor of using preconditioning concepts before surgery. Web-based interventions seem an innovative and effective tool for delivering general information, individualized exercise recommendations, and peer support. Objective: Our first objective was to assess feasibility of our Web-based interventional concept and analyze similarities and differences in a sustained exercise implementation in different diseases. The second objective was to investigate the overall participants’ satisfaction with our Web-based concept. Methods: A total of 4 clinical trials are still being carried out, including patients with esophageal carcinoma scheduled for oncologic esophagectomy (internet-based perioperative exercise program, iPEP, study), nonalcoholic fatty liver disease (hepatic inflammation and physical performance in patients with nonalcoholic steatohepatitis, HELP, study), depression (exercise for depression, EXDEP, study), and cystic fibrosis (cystic fibrosis online mentoring for microbiome, exercise, and diet, COMMED, study). During the intervention period, the study population had access to the website with disease-specific content and a disease-specific discussion forum. All participants received weekly, individual tailored exercise recommendations from the sports therapist. The main outcome was the using behavior, which was obtained by investigating the log-in rate and duration. Results: A total of 20 participants (5 from each trial) were analyzed. During the intervention period, a regular contact and a consequent implementation of exercise prescription were easily achieved in all substudies. Across the 4 substudies, there was a significant decrease in log-in rates (P<.001) and log-in durations (P<.001) over time. A detailed view of the different studies shows a significant decrease in log-in rates and log-in durations in the HELP study (P=.004; P=.002) and iPEP study (P=.02; P=.001), whereas the EXDEP study (P=.58; P=.38) and COMMED study (P=.87; P=.56) showed no significant change over the 8-week intervention period. There was no significant change in physical activity within all studies (P=.31). Only in the HELP study, the physical activity level increased steadily over the period analyzed (P=.045). Overall, 17 participants (85%, 17/20) felt secure and were not scared of injury, with no major differences in the subtrials. Conclusions: The universal use of the Web-based intervention appears to be applicable across the heterogonous collectives of our study patients with regard to age and disease. Although the development of physical activity shows only moderate improvements, flexible communication and tailored support could be easily integrated into patients’ daily routine. Trial Registration: iPEP study: ClinicalTrials.gov NCT02478996; https://clinicaltrials.gov/ct2/show/NCT02478996 (Archived by WebCite at http://www.webcitation.org/6zL1UmHaW); HELP study: ClinicalTrials.gov NCT02526732; http://www.webcitation.org/6zJjX7d6K (Archived by WebCite at http://www.webcitation.org/6Nch4ldcL); EXDEP study: ClinicalTrials.gov NCT02874833; https://clinicaltrials.gov/ct2/show/NCT02874833 (Archived by WebCite at http://www.webcitation.org/6zJjj7FuA) %M 29789277 %R 10.2196/resprot.8607 %U http://www.researchprotocols.org/2018/5/e106/ %U https://doi.org/10.2196/resprot.8607 %U http://www.ncbi.nlm.nih.gov/pubmed/29789277 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 5 %P e179 %T Increasing Physical Activity in Mothers Using Video Exercise Groups and Exercise Mobile Apps: Randomized Controlled Trial %A Mascarenhas,Maya Nina %A Chan,June Maylin %A Vittinghoff,Eric %A Van Blarigan,Erin Lynn %A Hecht,Frederick %+ Osher Center for Integrative Medicine, University of California, San Francisco, 1545 Divisadero Street, 4th Floor, San Francisco, CA,, United States, 1 415 890 2878, Maya.Mascarenhas@ucsf.edu %K mobile applications %K videoconferencing %K Internet %K health promotion %K exercise %K social support %K mothers %K randomized controlled trial %D 2018 %7 18.05.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Women significantly decrease their activity levels in the transition to motherhood. Digital health technologies are low cost, scalable, and can provide an effective delivery mechanism for behavior change. This is the first study that examines the use of videoconferencing and mobile apps to create exercise groups for mothers. Objective: The aim of the study was to test the feasibility, acceptability, and effectiveness of an individually adaptive and socially supportive physical activity intervention incorporating videoconferencing and mobile apps for mothers. Methods: The Moms Online Video Exercise Study was an 8-week, 2-armed, Web-based randomized trial comparing the effectiveness of a group exercise intervention with a waitlist control. Healthy mothers with at least 1 child under the age of 12 years were recruited through Facebook and email listservs. Intervention participants joined exercise groups using videoconferencing (Google Hangouts) every morning on weekdays and exercised together in real time, guided by exercise mobile apps (eg, Nike+, Sworkit) of their choice. Waitlist control participants had access to recommended mobile apps and an invitation to join an exercise group after the 8-week study period. Main outcomes assessed included changes in self-reported moderate, vigorous, and moderate to vigorous physical activity (MVPA) minutes per week in aggregate and stratified by whether women met Centers for Disease Control and Prevention guidelines for sufficient aerobic activity at baseline. Outcomes were measured through self-assessed Web-based questionnaires at baseline and 8 weeks. Results: The intervention was effective at increasing exercise for inactive women and proved to be feasible and acceptable to all participants. A total of 64 women were randomized, 30 to intervention and 34 to control. Women attended 2.8 sessions per week. There was a strong, but not statistically significant, trend toward increasing moderate, vigorous, and MVPA minutes for all women. As hypothesized, in the prespecified stratum of women who were inactive at baseline (n=51), intervention participants significantly increased their activity by an average of 50 (95% CI 4.0-95.9, P=.03) MVPA minutes per week more than control participants. They had a corresponding statistically significant net increase of 19 (95% CI 3.2-34.8, P=.02) minutes of vigorous activity. Inactive women in the intervention arm also experienced promising reductions in depression, reporting a statistically significant net decrease in their depression score (−3.8, 95% CI −7.0 to −0.6; P=.02). Conclusions: We found that a group exercise intervention using videoconferencing and mobile apps was a feasible and acceptable way to deliver a physical activity intervention to mothers. The intervention increased physical activity in inactive mothers. Further studies are needed to better establish how long these changes in physical activity can be maintained and whether these findings can be reproduced in a more diverse population. Trial Registration: ClinicalTrials.gov NCT02805140; https://clinicaltrials.gov/ct2/show/NCT02805140 (Archived by WebCite at http://www.webcitation.org/6yYZwRveg) %M 29776899 %R 10.2196/jmir.9310 %U http://www.jmir.org/2018/5/e179/ %U https://doi.org/10.2196/jmir.9310 %U http://www.ncbi.nlm.nih.gov/pubmed/29776899 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 5 %P e149 %T Psychobehavioral Profiles to Assist Tailoring of Interventions for Patients With Hypertension: Latent Profile Analysis %A Tanaka,Rika %A Nolan,Robert P %+ Cardiac eHealth and Behavioural Cardiology Research Unit, Peter Munk Cardiac Centre, University Health Network, 585 University Ave., 6NU-6N617, Toronto, ON, M5G 2N2, Canada, 1 416 340 4800 ext 6038, rika.tanaka@uhnresearch.ca %K hypertension %K depression %K health behavior %K lifestyle %K counseling %D 2018 %7 11.05.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Practice guidelines advocate combining pharmacotherapy with lifestyle counseling for patients with hypertension. To allow for appropriate tailoring of interventions to meet individual patient needs, a comprehensive understanding of baseline patient characteristics is essential. However, few studies have empirically assessed behavioral profiles of hypertensive patients in Web-based lifestyle counseling programs. Objective: The objectives of this study were to (1) specify baseline psychobehavioral profiles of patients with hypertension who were enrolled in a Web-based lifestyle counseling trial, and (2) examine mean differences among the identified profile groups in demographics, psychological distress, self-reported self-care behaviors, physiological outcomes, and program engagement to determine prognostic implications. Methods: Participants (N=264; mean age 57.5 years; 154/264, 58.3% female; 193/264, 73.1% white) were recruited into a longitudinal, double-blind, randomized controlled trial, designed to evaluate an online lifestyle intervention for hypertensive patients. A series of latent profile analyses identified psychobehavioral profiles, indicated by baseline measures of mood, motivation, and health behaviors. Mean differences between profile groups were then explored. Results: A 2-class solution provided the best model fit (the Bayesian information criterion (BIC) is 10,133.11; sample-size adjusted BIC is 10,006.54; Lo-Mendell-Rubin likelihood ratio test is 65.56, P=.001). The 2 profile groups were (1) adaptive adjustment, marked by low distress, high motivation, and somewhat satisfactory engagement in health behaviors and (2) affectively distressed, marked by clinically significant distress. At baseline, on average, affectively distressed patients had lower income, higher body mass index, and endorsed higher stress compared with their adaptive adjustment counterparts. At 12-months post intervention, treatment effects were sustained for systolic blood pressure and Framingham risk index in the adaptive adjustment group, and those in the adaptive adjustment group were 2.4 times more likely to complete the 12-month intervention study, compared with their affectively distressed counterparts. Conclusions: Interventions for patients who are adaptively adjusted may differ in focus from those designed for the affectively distressed patients. As such, this study underscores the importance of identifying psychobehavioral profiles, as they allow for evidence-based tailoring of lifestyle counseling programs for patients with hypertension. Trial Registration: ClinicalTrials.gov NCT01541540; https://clinicaltrials.gov/ct2/show/NCT01541540 (Archived by WebCite at http://www.webcitation.org/6yzZYZcWF) %M 29752248 %R 10.2196/jmir.8757 %U http://www.jmir.org/2018/5/e149/ %U https://doi.org/10.2196/jmir.8757 %U http://www.ncbi.nlm.nih.gov/pubmed/29752248 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 5 %P e10021 %T Moderators of Effects of Internet-Delivered Exercise and Pain Coping Skills Training for People With Knee Osteoarthritis: Exploratory Analysis of the IMPACT Randomized Controlled Trial %A Lawford,Belinda J %A Hinman,Rana S %A Kasza,Jessica %A Nelligan,Rachel %A Keefe,Francis %A Rini,Christine %A Bennell,Kim L %+ Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, 161 Barry Street, Melbourne, 3010, Australia, 61 3 8344 4135, k.bennell@unimelb.edu.au %K telerehabilitation %K moderators %K osteoarthritis %K exercise %D 2018 %7 09.05.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-delivered exercise, education, and pain coping skills training is effective for people with knee osteoarthritis, yet it is not clear whether this treatment is better suited to particular subgroups of patients. Objective: The aim was to explore demographic and clinical moderators of the effect of an internet-delivered intervention on changes in pain and physical function in people with knee osteoarthritis. Methods: Exploratory analysis of data from 148 people with knee osteoarthritis who participated in a randomized controlled trial comparing internet-delivered exercise, education, and pain coping skills training to internet-delivered education alone. Primary outcomes were changes in knee pain while walking (11-point Numerical Rating Scale) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index function subscale) at 3 and 9 months. Separate regression models were fit with moderator variables (age, gender, expectations of outcomes, self-efficacy [pain], education, employment status, pain catastrophizing, body mass index) and study group as covariates, including an interaction between the two. Results: Participants in the intervention group who were currently employed had significantly greater reductions in pain at 3 months than similar participants in the control group (between-group difference: mean 2.38, 95% CI 1.52-3.23 Numerical Rating Scale units; interaction P=.02). Additionally, within the intervention group, pain at 3 months reduced by mean 0.53 (95% CI 0.28-0.78) Numerical Rating Scale units per unit increase in baseline self-efficacy for managing pain compared to mean 0.11 Numerical Rating Scale units (95% CI –0.13 to 0.35; interaction P=.02) for the control group. Conclusions: People who were employed and had higher self-efficacy at baseline were more likely to experience greater improvements in pain at 3 months after an internet-delivered exercise, education, and pain coping skills training program. There was no evidence of a difference in the effect across gender, educational level, expectation of treatment outcome, or across age, body mass index, or tendency to catastrophize pain. Findings support the effectiveness of internet-delivered care for a wide range of people with knee osteoarthritis, but future confirmatory research is needed. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12614000243617; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365812&isReview=true (Archived by WebCite at http://www.webcitation.org/6z466oTPs) %M 29743149 %R 10.2196/10021 %U http://www.jmir.org/2018/5/e10021/ %U https://doi.org/10.2196/10021 %U http://www.ncbi.nlm.nih.gov/pubmed/29743149 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 5 %P e170 %T Web-Based Physical Activity Intervention for Latina Adolescents: Feasibility, Acceptability, and Potential Efficacy of the Niñas Saludables Study %A Larsen,Britta %A Benitez,Tanya %A Cano,Mayra %A Dunsiger,Shira S %A Marcus,Bess H %A Mendoza-Vasconez,Andrea %A Sallis,James F %A Zive,Michelle %+ Department of Family Medicine & Public Health, University of California, San Diego, 9500 Gilman Drive, San Diego, CA, 92093 0725, United States, 1 8585348429, blarsen@ucsd.edu %K exercise %K health behavior %K internet %K eHealth %K telemedicine %D 2018 %7 09.05.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Physical activity is markedly low in Latina adolescents, yet few physical activity interventions have been attempted in this population. Web-based interventions can incorporate theory-based components, be appealing to adolescents, and have potential for low-cost dissemination. Objective: This study aimed to assess the feasibility, acceptability, and potential efficacy of a Web-based physical activity intervention for Latina adolescents in a single-arm pilot trial. Methods: A total of 21 Latina adolescents (aged 12-18 years) who could read and write in English and were underactive (<90 min/week) participated in a 12-week, theory-informed Web-based physical activity intervention. The intervention website was modified from a previous Web-based intervention for Latina adults. Web content was individually tailored based on the responses to monthly questionnaires. Feasibility was measured by recruitment, retention, and adherence/engagement, and acceptability was measured by satisfaction surveys. Physical activity was measured at baseline and follow-up (12 weeks) using the 7-day physical activity recall (PAR) interview and accelerometers. Results: Baseline activity as measured by the 7-day PAR and accelerometers was 24.7 (SD 26.11) and 24.8 (SD 38.3) min/week, respectively. At 12 weeks, 19 participants (90%, 19/21) returned. Adherence and engagement with materials were low, but 72% (15/21) of the participants indicated that they were satisfied with the intervention. Activity at 12 weeks increased by 58.8 (SD 11.33) min/week measured by the 7-day PAR (P<.001). Accelerometer-measured activity did not increase. Activities reported at follow-up were more varied than at baseline, including some activities measured poorly by accelerometers (eg, biking and swimming). Participants suggested simplifying the website and incorporating other technologies. Conclusions: Good retention and increases in self-reported activity suggest a promising approach to delivering a physical activity intervention to Latina adolescents. Incorporating other technologies, such as smartphone apps, could make the intervention more engaging, acceptable, and effective. %M 29743151 %R 10.2196/jmir.9206 %U http://www.jmir.org/2018/5/e170/ %U https://doi.org/10.2196/jmir.9206 %U http://www.ncbi.nlm.nih.gov/pubmed/29743151 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 5 %P e166 %T Effects of Treatment Length and Chat-Based Counseling in a Web-Based Intervention for Cannabis Users: Randomized Factorial Trial %A Jonas,Benjamin %A Tensil,Marc-Dennan %A Tossmann,Peter %A Strüber,Evelin %+ Delphi Gesellschaft für Forschung, Beratung und Projektentwicklung, Kaiserdamm 8, Berlin, 14057, Germany, 49 30 39 40 97 82, jonas@delphi.de %K cannabis %K Internet %K counseling %K random allocation %D 2018 %7 08.05.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital interventions show promise in reducing problematic cannabis use. However, little is known about the effect of moderators in such interventions. The therapist-guided internet intervention Quit the Shit provides 50 days of chat-based (synchronous) and time-lagged (asynchronous) counseling. Objective: In the study, we examined whether the effectiveness of Quit the Shit is reduced by shortening the program or by removing the chat-based counseling option. Methods: We conducted a purely Web-based randomized experimental trial using a two-factorial design (factor 1: real-time-counseling via text-chat: yes vs no; factor 2: intervention duration: 50 days vs 28 days). Participants were recruited on the Quit the Shit website. Follow-ups were conducted 3, 6, and 12 months after randomization. Primary outcome was cannabis-use days during the past 30 days using a Timeline Followback procedure. Secondary outcomes were cannabis quantity, cannabis-use events, cannabis dependency (Severity of Dependence Scale), treatment satisfaction (Client Satisfaction Questionnaire), and working alliance (Working Alliance Inventory-short revised). Results: In total, 534 participants were included in the trial. Follow-up rates were 47.2% (252/534) after 3 months, 38.2% (204/534) after 6 months, and 25.3% (135/534) after 12 months. Provision of real-time counseling (factor 1) was not significantly associated with any cannabis-related outcome but with higher treatment satisfaction (P=.001, d=0.34) and stronger working alliance (P=.008, d=0.22). In factor 2, no significant differences were found in any outcome. The reduction of cannabis use among all study participants was strong (P<.001, d≥1.13). Conclusions: The reduction of program length and the waiver of synchronous communication have no meaningful impact on the effectiveness of Quit the Shit. It therefore seems tenable to abbreviate the program and to offer a self-guided start into Quit the Shit. Due to its positive impact on treatment satisfaction and working alliance, chat-based counseling nevertheless should be provided in Quit the Shit. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN99818059; http://www.isrctn.com/ISRCTN99818059 (Archived by WebCite at http://www.webcitation.org/6uVDeJjfD) %M 29739738 %R 10.2196/jmir.9579 %U http://www.jmir.org/2018/5/e166/ %U https://doi.org/10.2196/jmir.9579 %U http://www.ncbi.nlm.nih.gov/pubmed/29739738 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 5 %P e163 %T Electronic Health Physical Activity Behavior Change Intervention to Self-Manage Cardiovascular Disease: Qualitative Exploration of Patient and Health Professional Requirements %A Walsh,Deirdre MJ %A Moran,Kieran %A Cornelissen,Véronique %A Buys,Roselien %A Cornelis,Nils %A Woods,Catherine %+ MedEx Wellness, School of Health and Human Performance, Dublin City Unviersity, Room A246, Albert College, Dublin, Dublin 9, Ireland, 353 1 7008011, kieran.moran@dcu.ie %K telemedicine %K exercise %K cardiovascular diseases %K rehabilitation %D 2018 %7 08.05.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Cardiovascular diseases are a leading cause of premature death worldwide. International guidelines recommend routine delivery of all phases of cardiac rehabilitation. Uptake of traditional cardiac rehabilitation remains suboptimal, as attendance at formal hospital-based cardiac rehabilitation programs is low, with community-based cardiac rehabilitation rates and individual long-term exercise maintenance even lower. Home-based cardiac rehabilitation programs have been shown to be equally effective in clinical and health-related quality of life outcomes and yet are not readily available. Objective: Given the potential that home-based cardiac rehabilitation programs have, it is important to explore how to appropriately design any such intervention in conjunction with key stakeholders. The aim of this study was to engage with individuals with cardiovascular disease and other professionals within the health ecosystem to (1) understand the personal, social, and physical factors that inhibit or promote their capacity to engage with physical activity and (2) explore their technology competencies, needs, and wants in relation to an eHealth intervention. Methods: Fifty-four semistructured interviews were conducted across two countries. Interviews were audiotaped, transcribed verbatim, and analyzed using thematic analysis. Barriers to the implementation of PATHway were also explored specifically in relation to physical capability and safety as well as technology readiness and further mapped onto the COM-B model for future intervention design. Results: Key recommendations included collection of patient data and use of measurements, harnessing hospital based social connections, and advice to utilize a patient-centered approach with personalization and tailoring to facilitate optimal engagement. Conclusions: In summary, a multifaceted, personalizable intervention with an inclusively designed interface was deemed desirable for use among cardiovascular disease patients both by end users and key stakeholders. In-depth understanding of core needs of the population can aid intervention development and acceptability. %M 29739740 %R 10.2196/jmir.9181 %U http://www.jmir.org/2018/5/e163/ %U https://doi.org/10.2196/jmir.9181 %U http://www.ncbi.nlm.nih.gov/pubmed/29739740 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 5 %P e172 %T Effectiveness of Internet-Based Interventions on Glycemic Control in Patients With Type 2 Diabetes: Meta-Analysis of Randomized Controlled Trials %A Shen,Ying %A Wang,Fengbin %A Zhang,Xing %A Zhu,Xiaorou %A Sun,Qiudan %A Fisher,Edwin %A Sun,Xinying %+ School of Public Health, Peking University Health Science Center, 38, Xueyuan Road, Haidian District, Beijing, China, Beijing, 100191, China, 86 86 13691212050, xysun@bjmu.edu.cn %K internet %K type 2 diabetes mellitus %K HbA1c %K randomized controlled trial %K meta-analysis %D 2018 %7 07.05.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: The popularity of internet as an area of research has grown manifold over the years. Given its rapid development and increasing coverage worldwide, internet-based interventions seem to offer a promising option to ameliorate huge burdens brought by type 2 diabetes mellitus. However, studies conducted by different researchers have provided contradictory results on the effect of internet-based interventions in glycemic control. Objective: This meta-analysis aims to summarize currently available evidence and evaluate the overall impact of internet-based interventions on glycemic management of type 2 diabetic patients. Methods: A systematic literature search was performed in PubMed, ScienceDirect, and Web of Science. Randomized controlled trials that used glycosylated hemoglobin values as the outcome measure of glycemic control were considered. Risk of bias and publication bias were evaluated. Results: Of the 492 studies, 35 were included in meta-analysis, and results indicated that the weighted mean difference (WMD) between usual care and internet-based interventions at endpoint was –0.426% (95% CI –0.540 to –0.312; P<.001). Subgroup analyses revealed that intervention duration ≤3 months yielded optimal performance (WMD –0.51%; 95% CI –0.71 to –0.31; P<.001). Combined mobile and website interventions were substantially superior to solely Web-based and mobile-based interventions in glycemic control (combined WMD –0.77%, 95% CI –1.07 to –0.47; P<.001; Web only: WMD –0.48%; 95% CI –0.71 to –0.24, P<.001; mobile only WMD –0.31%, 95% CI –0.49 to –0.14; P<.001). Furthermore, the effect of interventions with automated feedbacks was similar to those with manual feedbacks, and studies with internet-based educational contents were more effective in glycemic control. The assessment revealed a low risk of bias. Conclusions: In conclusion, utilization of internet-based intervention is beneficial for patients with type 2 diabetes mellitus, and taking full advantage of this type of intervention may substantially reduce the incidence of complications and improve quality of life. Trial Registration: International Prospective Register of Systematic Reviews (PROSPERO): CRD42017058032; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=58032 (Archived by WebCite at http://www.webcitation.org/6yY7eQNHr) %M 29735475 %R 10.2196/jmir.9133 %U http://www.jmir.org/2018/5/e172/ %U https://doi.org/10.2196/jmir.9133 %U http://www.ncbi.nlm.nih.gov/pubmed/29735475 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 5 %P e174 %T Behind the Scenes of Online Therapeutic Feedback in Blended Therapy for Depression: Mixed-Methods Observational Study %A Mol,Mayke %A Dozeman,Els %A Provoost,Simon %A van Schaik,Anneke %A Riper,Heleen %A Smit,Johannes H %+ Department of Psychiatry, Amsterdam Public Health Research Institute, VU University Medical Center, Van der Boechorststraat 7, Amsterdam, 1081 BT, Netherlands, 31 204448180, m.mol@ggzingeest.nl %K cognitive behavioral therapy %K eHealth %K depressive disorder %D 2018 %7 03.05.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: In Internet-delivered cognitive behavioral therapies (iCBT), written feedback by therapists is a substantial part of therapy. However, it is not yet known how this feedback should be given best and which specific therapist behaviors and content are most beneficial for patients. General instructions for written feedback are available, but the uptake and effectiveness of these instructions in iCBT have not been studied yet. Objective: This study aimed to identify therapist behaviors in written online communication with patients in blended CBT for adult depression in routine secondary mental health care, to identify the extent to which the therapists adhere to feedback instructions, and to explore whether therapist behaviors and adherence to feedback instructions are associated with patient outcome. Methods: Adults receiving blended CBT (10 online sessions in combination with 5 face-to-face sessions) for depression in routine mental health care were recruited in the context of the European implementation project MasterMind. A qualitative content analysis was used to identify therapist behaviors in online written feedback messages, and a checklist for the feedback instruction adherence of the therapists was developed. Correlations were explored between the therapist behaviors, therapist instruction adherence, and patient outcomes (number of completed online sessions and symptom change scores). Results: A total of 45 patients (73%, 33/45 female, mean age 35.9 years) received 219 feedback messages given by 19 therapists (84%, 16/19 female). The most frequently used therapist behaviors were informing, encouraging, and affirming. However, these were not related to patient outcomes. Although infrequently used, confronting was positively correlated with session completion (ρ=.342, P=.02). Therapists adhered to most of the feedback instructions. Only 2 feedback aspects were correlated with session completion: the more therapists adhere to instructions containing structure (limiting to 2 subjects and sending feedback within 3 working days) and readability (short sentences and short paragraphs), the less online sessions were completed (ρ=−.340, P=.02 and ρ=−.361, P=.02, respectively). No associations were found with depression symptom change scores. Conclusions: The therapist behaviors found in this study are comparable to previous research. The findings suggest that online feedback instructions for therapists provide sufficient guidance to communicate in a supportive and positive manner with patients. However, the instructions might be improved by adding more therapeutic techniques besides the focus on style and form. %M 29724708 %R 10.2196/jmir.9890 %U http://www.jmir.org/2018/5/e174/ %U https://doi.org/10.2196/jmir.9890 %U http://www.ncbi.nlm.nih.gov/pubmed/29724708 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 5 %P e10028 %T A Mental Health Storytelling Intervention Using Transmedia to Engage Latinas: Grounded Theory Analysis of Participants’ Perceptions of the Story’s Main Character %A Heilemann,MarySue V %A Martinez,Adrienne %A Soderlund,Patricia D %+ School of Nursing, University of California, Los Angeles, Factor Building, Room 5252, Box 956919, Los Angeles, CA, 90095 6919, United States, 1 310 206 4735, mheilema@sonnet.ucla.edu %K depression %K anxiety %K transmedia storytelling %K Internet %K cell phone %K mental health %K eHealth %K mood disorders %K smartphone %D 2018 %7 02.05.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Transmedia storytelling was used to attract English-speaking Latina women with elevated symptoms of depression and anxiety to engage in an intervention that included videos and a webpage with links to symptom management resources. However, a main character for the storyline who was considered dynamic, compelling, and relatable by the target group was needed. Objective: We conducted interviews with 28 English-speaking Latinas (target group) with elevated symptoms of depression or anxiety who participated in an Internet-accessible transmedia storytelling intervention. The objective of this study was to examine participants’ perceptions of the lead character of the story. Development of this character was informed by deidentified data from previous studies with members of the target group. Critique of the character from a panel of therapists informed editing, as did input from women of the target group. Methods: All interviews were conducted via telephone, audio-recorded, and transcribed. Data analysis was guided by grounded theory methodology. Results: Participants embraced the main character, Catalina, related to her as a person with an emotional life and a temporal reality, reported that they learned from her and wanted more episodes that featured her and her life. Grounded theory analysis led to the development of one category (She “just felt so real”: relating to Catalina as a real person with a past, present, and future) with 4 properties. Properties included (1) relating emotionally to Catalina’s vulnerability, (2) recognizing shared experiences, (3) needing to support others while simultaneously lacking self-support, and (4) using Catalina as a springboard for imagining alternative futures. Participants found Catalina’s efforts to pursue mental health treatment to be meaningful and led them to compare themselves to her and consider how they might pursue treatment themselves. Conclusions: When creating a story-based mental health intervention to be delivered through an app, regardless of type, careful development of the main character is valuable. Theoretical guidance, previous deidentified data from the target group, critique from key stakeholders and members of the target group, and preliminary testing are likely to enhance the main character’s relatability and appropriateness, which can increase sustained engagement. %M 29720357 %R 10.2196/10028 %U http://www.jmir.org/2018/5/e10028/ %U https://doi.org/10.2196/10028 %U http://www.ncbi.nlm.nih.gov/pubmed/29720357 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 5 %P e160 %T Web-Based Intervention for Women With Type 1 Diabetes in Pregnancy and Early Motherhood: Critical Analysis of Adherence to Technological Elements and Study Design %A Berg,Marie %A Linden,Karolina %A Adolfsson,Annsofie %A Sparud Lundin,Carina %A Ranerup,Agneta %+ Centre for Person-Centred Care (GPCC), Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Box 457, Gothenburg, 405 30, Sweden, 46 31 7866084, marie.berg@fhs.gu.se %K randomized controlled trial %K eHealth %K mHealth %K case study %D 2018 %7 02.05.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Numerous Web-based interventions have been implemented to promote health and health-related behaviors in persons with chronic conditions. Using randomized controlled trials to evaluate such interventions creates a range of challenges, which in turn can influence the study outcome. Applying a critical perspective when evaluating Web-based health interventions is important. Objective: The objective of this study was to critically analyze and discuss the challenges of conducting a Web-based health intervention as a randomized controlled trial. Method: The MODIAB-Web study was critically examined using an exploratory case study methodology and the framework for analysis offered through the Persuasive Systems Design model. Focus was on technology, study design, and Web-based support usage, with special focus on the forum for peer support. Descriptive statistics and qualitative content analysis were used. Results: The persuasive content and technological elements in the design of the randomized controlled trial included all four categories of the Persuasive Systems Design model, but not all design principles were implemented. The study duration was extended to a period of four and a half years. Of 81 active participants in the intervention group, a maximum of 36 women were simultaneously active. User adherence varied greatly with a median of 91 individual log-ins. The forum for peer support was used by 63 participants. Although only about one-third of the participants interacted in the forum, there was a fairly rich exchange of experiences and advice between them. Thus, adherence in terms of social interactions was negatively affected by limited active participation due to prolonged recruitment process and randomization effects. Lessons learned from this critical analysis are that technology and study design matter and might mutually influence each other. In Web-based interventions, the use of design theories enables utilization of the full potential of technology and promotes adherence. The randomization element in a randomized controlled trial design can become a barrier to achieving a critical mass of user interactions in Web-based interventions, especially when social support is included. For extended study periods, the technology used may need to be adapted in line with newly available technical options to avoid the risk of becoming outdated in the user realm, which in turn might jeopardize study validity in terms of randomized controlled trial designs. Conclusions: On the basis of lessons learned in this randomized controlled trial, we give recommendations to consider when designing and evaluating Web-based health interventions. %M 29720365 %R 10.2196/jmir.9665 %U http://www.jmir.org/2018/5/e160/ %U https://doi.org/10.2196/jmir.9665 %U http://www.ncbi.nlm.nih.gov/pubmed/29720365 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 4 %N 2 %P e34 %T A Gamified Smartphone App to Support Engagement in Care and Medication Adherence for HIV-Positive Young Men Who Have Sex With Men (AllyQuest): Development and Pilot Study %A Hightow-Weidman,Lisa %A Muessig,Kathryn %A Knudtson,Kelly %A Srivatsa,Mala %A Lawrence,Ellena %A LeGrand,Sara %A Hotten,Anna %A Hosek,Sybil %+ Institute of Global Health and Infectious Diseases, University of North Carolina, Bioinformatics Building, Suite 2154, 130 Mason Farm Road, Chapel Hill, NC, 27599-7030, United States, 1 919 843 0033, lisa_hightow@med.unc.edu %K YMSM %K antiretroviral adherence %K smartphone app %K gamification %K social networking %D 2018 %7 30.04.2018 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: HIV disproportionately impacts young men who have sex with men (YMSM) who experience disparities across the HIV care continuum. Addressing antiretroviral therapy (ART) adherence among YMSM is an urgent public health priority. Technology-based interventions—particularly mobile health platforms—can provide tailored adherence interventions and allow YMSM to engage and connect with others. Objective: The objective of this study was to describe the development of AllyQuest, a novel, theoretically-based, smartphone app designed to improve engagement in care and ART adherence and social support among HIV-positive YMSM. Methods: AllyQuest was built on an established platform for patient engagement that embeds social networking and fundamental game mechanics, such as challenges, points, and rewards. A medication tracker provides reminders to promote ART adherence via personalized adherence strategies that are user and context specific; a calendar allows for reflection on adherence over time. After iterative development with input from two youth advisory boards, usability testing was conducted to assess app functionality, comprehension of the educational content, use of intervention features, and overall impressions of app relevance and appeal. A 28-day pilot trial was conducted with 20 HIV+ YMSM to evaluate intervention feasibility and acceptability. Results: Mean age of participants was 21.8 years (range 19-24), and 95% (19/20) of the participants were nonwhite. The mean time of app use was 158.4 min (SD 114.1), with a range of 13 to 441 min. There was a mean of 21.2 days of use (out of a total possible 28 days). There were 222 posts to the daily discussion social wall. Feasibility and acceptability ratings were high. Overall, participants found the app easy to use and navigate, not intrusive, and had few reported technical issues. Higher levels of app usage were positively correlated with HIV self-management outcomes, and there was a statistically significant (P<.05) positive association between the number of days logged into the app and knowledge and confidence in ability to reliably take HIV medications. Conclusions: AllyQuest represents a new, highly scalable solution that is well-suited to meet the specific prevention and care needs of HIV+ YMSM. The development of this intervention is both timely and vital, given the urgency of the ongoing HIV epidemic among YMSM. %M 29712626 %R 10.2196/publichealth.8923 %U http://publichealth.jmir.org/2018/2/e34/ %U https://doi.org/10.2196/publichealth.8923 %U http://www.ncbi.nlm.nih.gov/pubmed/29712626 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 4 %P e159 %T Efficacy of a Community-Based Technology-Enabled Physical Activity Counseling Program for People With Knee Osteoarthritis: Proof-of-Concept Study %A Li,Linda C %A Sayre,Eric C %A Xie,Hui %A Falck,Ryan S %A Best,John R %A Liu-Ambrose,Teresa %A Grewal,Navi %A Hoens,Alison M %A Noonan,Greg %A Feehan,Lynne M %+ Arthritis Research Canada, 5591 No. 3 Road, Richmond, BC, V6X 2C7, Canada, 1 604 207 4020, lli@arthritisresearch.ca %K osteoarthritis %K physical activity %K wearables %K goal setting %K physiotherapy %K eHealth %D 2018 %7 30.04.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Current practice guidelines emphasize the use of physical activity as the first-line treatment of knee osteoarthritis; however, up to 90% of people with osteoarthritis are inactive. Objective: We aimed to assess the efficacy of a technology-enabled counseling intervention for improving physical activity in people with either a physician-confirmed diagnosis of knee osteoarthritis or having passed two validated criteria for early osteoarthritis. Methods: We conducted a proof-of-concept randomized controlled trial. The immediate group received a brief education session by a physical therapist, a Fitbit Flex, and four biweekly phone calls for activity counseling. The delayed group received the same intervention 2 months later. Participants were assessed at baseline (T0) and at the end of 2 months (T1), 4 months (T2), and 6 months (T3). Outcomes included (1) mean time on moderate-to-vigorous physical activity (MVPA ≥3 metabolic equivalents [METs], primary outcome), (2) mean time on MVPA ≥4 METs, (3) mean daily steps, (4) mean time on sedentary activities, (5) Knee Injury and Osteoarthritis Outcome Score (KOOS), and (6) Partners in Health scale. Mixed-effects repeated measures analysis of variance was used to assess five planned contrasts of changes in outcome measures over measurement periods. The five contrasts were (1) immediate T1-T0 vs delayed T1-T0, (2) delayed T2-T1 vs delayed T1-T0, (3) mean of contrast 1 and contrast 2, (4) immediate T1-T0 vs delayed T2-T1, and (5) mean of immediate T2-T1 and delayed T3-T2. The first three contrasts estimate the between-group effects. The latter two contrasts estimate the effect of the 2-month intervention delay on outcomes. Results: We recruited 61 participants (immediate: n=30; delayed: n=31). Both groups were similar in age (immediate: mean 61.3, SD 9.4 years; delayed: mean 62.1, SD 8.5 years) and body mass index (immediate: mean 29.2, SD 5.5 kg/m2; delayed: mean 29.2, SD 4.8 kg/m2). Contrast analyses revealed significant between-group effects in MVPA ≥3 METs (contrast 1 coefficient: 26.6, 95% CI 4.0-49.1, P=.02; contrast 3 coefficient: 26.0, 95% CI 3.1-49.0, P=.03), daily steps (contrast 1 coefficient: 1699.2, 95% CI 349.0-3049.4, P=.02; contrast 2 coefficient: 1601.8, 95% CI 38.7-3164.9, P=.045; contrast 3 coefficient: 1650.5, 95% CI 332.3-2968.7; P=.02), KOOS activity of daily living subscale (contrast 1 coefficient: 6.9, 95% CI 0.1-13.7, P=.047; contrast 3 coefficient: 7.2, 95% CI 0.8-13.6, P=.03), and KOOS quality of life subscale (contrast 1 coefficient: 7.4, 95% CI 0.0-14.7, P=.049; contrast 3 coefficient: 7.3, 95% CI 0.1-14.6, P=.048). We found no significant effect in any outcome measures due to the 2-month delay of the intervention. Conclusions: Our counseling program improved MVPA ≥3 METs, daily steps, activity of daily living, and quality of life in people with knee osteoarthritis. These findings are important because an active lifestyle is an important component of successful self-management. Trial Registration: ClinicalTrials.gov NCT02315664; https://clinicaltrials.gov/ct2/show/NCT02315664 (Archived by WebCite at http://www.webcitation.org/6ynSgUyUC) %M 29712630 %R 10.2196/jmir.8514 %U http://www.jmir.org/2018/4/e159/ %U https://doi.org/10.2196/jmir.8514 %U http://www.ncbi.nlm.nih.gov/pubmed/29712630 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 2 %N 1 %P e10323 %T A Hybrid Web-Based and In-Person Self-Management Intervention Aimed at Preventing Acute to Chronic Pain Transition After Major Lower Extremity Trauma: Feasibility and Acceptability of iPACT-E-Trauma %A Bérubé,Mélanie %A Gélinas,Céline %A Feeley,Nancy %A Martorella,Géraldine %A Côté,José %A Laflamme,G Yves %A Rouleau,Dominique M %A Choinière,Manon %+ Centre intégré universitaire du Nord-de-l’Île-de-Montréal, Hôpital du Sacré-Coeur de Montréal, Trauma Program and Department of Nursing, 5400 Boulevard Gouin Ouest, Montreal, QC, H4J 1C5, Canada, 1 514 338 2222 ext 2654, melanie.berube2@mail.mcgill.ca %K Acute pain %K chronic pain %K wound and injuries %K lower extremity %K self-care %K health promotion %K feasibility studies %K patient acceptance of health care %D 2018 %7 30.04.2018 %9 Original Paper %J JMIR Formativ Res %G English %X Background: A transition from acute to chronic pain frequently occurs after major lower extremity trauma. While the risk factors for developing chronic pain in this population have been extensively studied, research findings on interventions aiming to prevent chronic pain in the trauma context are scarce. Therefore, we developed a hybrid, Web-based and in-person, self-management intervention to prevent acute to chronic pain transition after major lower extremity trauma (iPACT-E-Trauma). Objective: This study aimed to assess the feasibility and acceptability of iPACT-E-Trauma. Methods: Using a descriptive design, the intervention was initiated at a supra-regional level-1 trauma center. Twenty-eight patients ≥18 years old with major lower extremity trauma, presenting with moderate to high pain intensity 24 hours post-injury were recruited. Feasibility assessment was two-fold: 1) whether the intervention components could be provided as planned to ≥80% of participants and 2) whether ≥80% of participants could complete the intervention. The rates for both these variables were calculated. The E-Health Acceptability Questionnaire and the Treatment Acceptability and Preference Questionnaire were used to assess acceptability. Mean scores were computed to determine the intervention’s acceptability. Results: More than 80% of participants received the session components relevant to their condition. However, the Web pages for session 2, on the analgesics prescribed, were accessed by 71% of participants. Most sessions were delivered according to the established timeline for ≥80% of participants. Session 3 and in-person coaching meetings had to be provider earlier for ≥35% of participants. Session duration was 30 minutes or less on average, as initially planned. More than 80% of participants attended sessions and <20% did not apply self-management behaviors relevant to their condition, with the exception of deep breathing relaxation exercises which was not applied by 40% of them. Web and in-person sessions were assessed as very acceptable (mean scores ≥3 on a 0 to 4 descriptive scale) across nearly all acceptability attributes. Conclusions: Findings showed that the iPACT-E-Trauma intervention is feasible and was perceived as highly acceptable by participants. Further tailoring iPACT-E-Trauma to patient needs, providing more training time for relaxation techniques, and modifying the Web platform to improve its convenience could enhance the feasibility and acceptability of the intervention. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 91987302; http://www.controlled-trials.com/ISRCTN91987302 (Archived by WebCite at http://www.webcitation.org/6ynibjPHa) %M 30684418 %R 10.2196/10323 %U http://formative.jmir.org/2018/1/e10323/ %U https://doi.org/10.2196/10323 %U http://www.ncbi.nlm.nih.gov/pubmed/30684418 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 4 %N 1 %P e8 %T A Web-Based Intervention to Reduce Distress After Prostate Cancer Treatment: Development and Feasibility of the Getting Down to Coping Program in Two Different Clinical Settings %A Cockle-Hearne,Jane %A Barnett,Deborah %A Hicks,James %A Simpson,Mhairi %A White,Isabel %A Faithfull,Sara %+ School of Health Sciences, Faculty of Health and Medical Sciences, University of Surrey, Duke of Kent Building, Stag Hill Campus, Guildford, GU2 7XH, United Kingdom, 44 1483 684585, j.cockle-hearne@surrey.ac.uk %K prostatic neoplasms %K Internet %K self-management %K cognitive behavior therapy %K primary health care %K secondary care %D 2018 %7 30.04.2018 %9 Original Paper %J JMIR Cancer %G English %X Background: Distress after prostate cancer treatment is a substantial burden for up to one-third of men diagnosed. Physical and emotional symptoms and health service use can intensify, yet men are reticent to accept support. To provide accessible support that can be cost effectively integrated into care pathways, we developed a unique, Web-based, self-guided, cognitive-behavior program incorporating filmed and interactive peer support. Objective: To assess feasibility of the intervention among men experiencing distress after prostate cancer treatment. Demand, acceptability, change in distress and self-efficacy, and challenges for implementation in clinical practice were measured. Methods: A pre-post, within-participant comparison, mixed-methods research design was followed. Phase I and II were conducted in primary care psychological service and secondary care cancer service, respectively. Men received clinician-generated postal invitations: phase I, 432 men diagnosed <5 years; phase II, 606 men diagnosed <3.5 years. Consent was Web-based. Men with mild and moderate distress were enrolled. Web-based assessment included demographic, disease, treatment characteristics; distress (General Health Questionnaire-28); depression (Patient Health Questionnaire-9); anxiety (General Anxiety Disorder Scale-7); self-efficacy (Self-Efficacy for Symptom Control Inventory); satisfaction (author-generated, Likert-type questionnaire). Uptake and adherence were assessed with reference to the persuasive systems design model. Telephone interviews explored participant experience (phase II, n=10); interviews with health care professionals (n=3) explored implementation issues. Results: A total of 135 men consented (phase I, 61/432, 14.1%; phase II, 74/606, 12.2%); from 96 eligible men screened for distress, 32% (30/96) entered the intervention (phase I, n=10; phase II, n=20). Twenty-four completed the Web-based program and assessments (phase I, n=8; phase II, n=16). Adherence for phase I and II was module completion rate 63% (mean 2.5, SD 1.9) versus 92% (mean 3.7, SD 1.0); rate of completing cognitive behavior therapy exercises 77% (mean 16.1, SD 6.2) versus 88% (mean 18.6, SD 3.9). Chat room activity occurred among 63% (5/8) and 75% (12/16) of men, respectively. In phase I, 75% (6/8) of men viewed all the films; in phase II, the total number of unique views weekly was 16, 11, 11, and 10, respectively. The phase II mood diary was completed by 100% (16/16) of men. Satisfaction was high for the program and films. Limited efficacy testing indicated improvement in distress baseline to post intervention: phase I, P=.03, r=−.55; phase II, P=.001, r=−.59. Self-efficacy improved for coping P=.02, r=−.41. Service assessment confirmed ease of assimilation into clinical practice and clarified health care practitioner roles. Conclusions: The Web-based program is acceptable and innovative in clinical practice. It was endorsed by patients and has potential to positively impact the experience of men with distress after prostate cancer treatment. It can potentially be delivered in a stepped model of psychological support in primary or secondary care. Feasibility evidence is compelling, supporting further evaluative research to determine clinical and cost effectiveness. %M 29712628 %R 10.2196/cancer.8918 %U http://cancer.jmir.org/2018/1/e8/ %U https://doi.org/10.2196/cancer.8918 %U http://www.ncbi.nlm.nih.gov/pubmed/29712628 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 4 %P e148 %T A Single-Session, Web-Based Parenting Intervention to Prevent Adolescent Depression and Anxiety Disorders: Randomized Controlled Trial %A Cardamone-Breen,Mairead C %A Jorm,Anthony F %A Lawrence,Katherine A %A Rapee,Ronald M %A Mackinnon,Andrew J %A Yap,Marie Bee Hui %+ Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton, Melbourne, 3800, Australia, 61 399050723, marie.yap@monash.edu %K adolescent %K mental health %K depression, anxiety, parenting %K family %K preventive health services %K Internet %D 2018 %7 26.04.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression and anxiety disorders are significant contributors to burden of disease in young people, highlighting the need to focus preventive efforts early in life. Despite substantial evidence for the role of parents in the prevention of adolescent depression and anxiety disorders, there remains a need for translation of this evidence into preventive parenting interventions. To address this gap, we developed a single-session, Web-based, tailored psychoeducation intervention that aims to improve parenting practices known to influence the development of adolescent depression and anxiety disorders. Objective: The aim of this study was to evaluate the short-term effects of the intervention on parenting risk and protective factors and symptoms of depression and anxiety in adolescent participants. Methods: We conducted a single-blind, parallel group, superiority randomized controlled trial comparing the intervention with a 3-month waitlist control. The intervention is fully automated and consists of two components: (1) completion of an online self-assessment of current parenting practices against evidence-based parenting recommendations for the prevention of adolescent depression and anxiety disorders and (2) an individually tailored feedback report highlighting each parent’s strengths and areas for improvement based on responses to the self-assessment. A community sample of 349 parents, together with 327 adolescents (aged 12-15 years), were randomized to either the intervention or waitlist control condition. Parents and adolescents completed online self-reported assessments of parenting and adolescent symptoms of depression and anxiety at baseline, 1-month (parent-report of parenting only), and 3-month follow-up. Results: Compared with controls, intervention group parents showed significantly greater improvement in parenting risk and protective factors from baseline to 1-month and 3-month follow-up (F2,331.22=16.36, P<.001), with a small to medium effect size at 3-month follow-up (d=0.33). There were no significant effects of the intervention on adolescent-report of parenting or symptoms of depression or anxiety in the adolescents (all P>.05). Conclusions: Findings suggest that a single-session, individually tailored, Web-based parenting intervention can improve parenting factors that are known to influence the development of depression and anxiety in adolescents. However, our results do not support the effectiveness of the intervention in improving adolescent depression or anxiety symptoms in the short-term. Long-term studies are required to adequately assess the relationship between improving parenting factors and adolescent depression and anxiety outcomes. Nonetheless, this is a promising avenue for the translation of research into a low-cost, sustainable, universal prevention approach. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12615000247572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12615000247572 (Archived by WebCite at http://www.webcitation.org/6v1ha19XG) %M 29699964 %R 10.2196/jmir.9499 %U http://www.jmir.org/2018/4/e148/ %U https://doi.org/10.2196/jmir.9499 %U http://www.ncbi.nlm.nih.gov/pubmed/29699964 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 4 %P e154 %T Guided Web-Based Cognitive Behavior Therapy for Perfectionism: Results From Two Different Randomized Controlled Trials %A Rozental,Alexander %A Shafran,Roz %A Wade,Tracey D %A Kothari,Radha %A Egan,Sarah J %A Ekberg,Linda %A Wiss,Maria %A Carlbring,Per %A Andersson,Gerhard %+ Institute of Child Health, University College London, 30 Guilford Street, London, WC1N 1EH, United Kingdom, 44 0207 905 2232, r.shafran@ucl.ac.uk %K cognitive behavior therapy %K internet %K perfectionism %K follow-up studies %K cognitive therapy %D 2018 %7 26.04.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Perfectionism can become a debilitating condition that may negatively affect functioning in multiple areas, including mental health. Prior research has indicated that internet-based cognitive behavioral therapy can be beneficial, but few studies have included follow-up data. Objective: The objective of this study was to explore the outcomes at follow-up of internet-based cognitive behavioral therapy with guided self-help, delivered as 2 separate randomized controlled trials conducted in Sweden and the United Kingdom. Methods: In total, 120 participants randomly assigned to internet-based cognitive behavioral therapy were included in both intention-to-treat and completer analyses: 78 in the Swedish trial and 62 in the UK trial. The primary outcome measure was the Frost Multidimensional Perfectionism Scale, Concern over Mistakes subscale (FMPS CM). Secondary outcome measures varied between the trials and consisted of the Clinical Perfectionism Questionnaire (CPQ; both trials), the 9-item Patient Health Questionnaire (PHQ-9; Swedish trial), the 7-item Generalized Anxiety Disorder scale (GAD-7; Swedish trial), and the 21-item Depression Anxiety Stress Scale (DASS-21; UK trial). Follow-up occurred after 6 months for the UK trial and after 12 months for the Swedish trial. Results: Analysis of covariance revealed a significant difference between pretreatment and follow-up in both studies. Intention-to-treat within-group Cohen d effect sizes were 1.21 (Swedish trial; 95% CI 0.86-1.54) and 1.24 (UK trial; 95% CI 0.85-1.62) for the FMPS CM. Furthermore, 29 (59%; Swedish trial) and 15 (43%; UK trial) of the participants met the criteria for recovery on the FMPS CM. Improvements were also significant for the CPQ, with effect sizes of 1.32 (Swedish trial; 95% CI 0.97-1.66) and 1.49 (UK trial; 95% CI 1.09-1.88); the PHQ-9, effect size 0.60 (95% CI 0.28-0.92); the GAD-7, effect size 0.67 (95% CI 0.34-0.99); and the DASS-21, effect size 0.50 (95% CI 0.13-0.85). Conclusions: The results are promising for the use of internet-based cognitive behavioral therapy as a way of targeting perfectionism, but the findings need to be replicated and include a comparison condition. %M 29699968 %R 10.2196/jmir.9823 %U http://www.jmir.org/2018/4/e154/ %U https://doi.org/10.2196/jmir.9823 %U http://www.ncbi.nlm.nih.gov/pubmed/29699968 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 4 %P e156 %T Effects of a 12-Week Digital Care Program for Chronic Knee Pain on Pain, Mobility, and Surgery Risk: Randomized Controlled Trial %A Mecklenburg,Gabriel %A Smittenaar,Peter %A Erhart-Hledik,Jennifer C %A Perez,Daniel A %A Hunter,Simon %+ Hinge Health, Inc, 818 Mission St, Ste 200, San Francisco, CA,, United States, 1 415 349 7757, gabriel@hingehealth.com %K osteoarthritis, knee %K chronic pain %K exercise %K education %K cognitive behavioral therapy %K computers, handheld %K coaching %K non-invasive %K digital health %K digital therapy %K digital care program %D 2018 %7 25.04.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic knee pain, most commonly caused by knee osteoarthritis, is a prevalent condition which in most cases can be effectively treated through conservative, non-surgical care involving exercise therapy, education, psychosocial support, and weight loss. However, most people living with chronic knee pain do not receive adequate care, leading to unnecessary use of opiates and surgical procedures. Objective: Assess the efficacy of a remotely delivered digital care program for chronic knee pain. Methods: We enrolled 162 participants into a randomized controlled trial between January and March 2017. Participants were recruited from participating employers using questionnaires for self-assessment of their knee pain, and randomized into treatment (n=101) and control (n=61) groups. Participants in the treatment group were enrolled in the Hinge Health digital care program for chronic knee pain. This is a remotely delivered, home-based 12-week intervention that includes sensor-guided exercise therapy, education, cognitive behavioral therapy, weight loss, and psychosocial support through a personal coach and team-based interactions. The control group received three education pieces regarding self-care for chronic knee pain. Both groups had access to treatment-as-usual. The primary outcome was the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale and KOOS Physical Function Shortform (KOOS-PS). Secondary outcomes were visual analog scales (VAS) for pain and stiffness respectively, surgery intent, and self-reported understanding of the condition and treatment options. Outcome measures were analyzed by intention to treat (excluding 7 control participants who received the digital care program due to administrative error) and per protocol. Results: In an intent-to-treat analysis the digital care program group had a significantly greater reduction in KOOS Pain compared to the control group at the end of the program (greater reduction of 7.7, 95% CI 3.0 to 12.3, P=.002), as well as a significantly greater improvement in physical function (7.2, 95% CI 3.0 to 11.5, P=.001). This was also reflected in the secondary outcomes VAS pain (12.3, 95% CI 5.4 to 19.1, P<.001) and VAS stiffness (13.4, 95% CI 5.6 to 21.1, P=.001). Participants’ self-reported likelihood (from 0% to 100%) of having surgery also reduced more strongly in the digital care program group compared to the control group over the next 1 year (–9.4 percentage points, pp, 95% CI –16.6 to –2.2, P=.01), 2 years (–11.3 pp, 95% CI –20.1 to –2.5, P=.01), and 5 years (–14.6 pp, 95% CI –23.6 to –5.5, P=.002). Interest in surgery (from 0 to 10) also reduced more so in the digital care program compared to control group (–1.0, 95% CI –1.7 to –0.2, P=.01). Participants’ understanding of the condition and treatment options (on a scale from 0 to 4) increased more substantially for participants in the digital care program than those in the control group (0.9, 95% CI 0.6 to 1.3, P<.001). In an analysis on participants that completed the intervention (per protocol analysis) all primary and secondary outcomes remained significant at greater effect magnitudes compared to intention to treat, with those completing the program showing a 61% (95% CI 48 to 74) reduction in VAS pain compared to 21% (95% CI 5 to 38) in the control group (P<.001). Accounting for the cost of administering the program, we estimate net cost savings on surgery alone of US $4340 over 1 year and $7900 over 5 years for those participants completing the digital care program compared to those in the control group receiving treatment-as-usual. In an exploratory subgroup analysis including only participants exhibiting clinical symptoms of osteoarthritis the program proved equally effective. Conclusions: This trial provides strong evidence that a comprehensive 12-week digital care program for chronic knee pain, including osteoarthritis, yields significantly improved outcomes for pain, physical function, stiffness, surgery risk, and understanding of the condition, compared to a control group. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 13307390; http://www.isrctn.com/ISRCTN13307390 (Archived by WebCite at http://www.webcitation.org/6ycwjGL73) %M 29695370 %R 10.2196/jmir.9667 %U http://www.jmir.org/2018/4/e156/ %U https://doi.org/10.2196/jmir.9667 %U http://www.ncbi.nlm.nih.gov/pubmed/29695370 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 4 %P e136 %T Effectiveness of an Internet- and App-Based Intervention for College Students With Elevated Stress: Randomized Controlled Trial %A Harrer,Mathias %A Adam,Sophia Helen %A Fleischmann,Rebecca Jessica %A Baumeister,Harald %A Auerbach,Randy %A Bruffaerts,Ronny %A Cuijpers,Pim %A Kessler,Ronald C %A Berking,Matthias %A Lehr,Dirk %A Ebert,David Daniel %+ Clinical Psychology and Psychotherapy, Friedrich-Alexander-University Erlangen-Nuremberg, Nägelsbachstraße 25a, Erlangen, 91052, Germany, 49 1708237654, mathias.harrer@fau.de %K randomized controlled trial %K stress, psychological %K depression %K telemedicine %K students %K help-seeking behavior %D 2018 %7 23.04.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Mental health problems are highly prevalent among college students. Most students with poor mental health, however, do not receive professional help. Internet-based self-help formats may increase the utilization of treatment. Objective: The aim of this randomized controlled trial was to evaluate the efficacy of an internet-based, app-supported stress management intervention for college students. Methods: College students (n=150) with elevated levels of stress (Perceived Stress Scale 4-item version, PSS-4 ≥8) were randomly assigned to either an internet- and mobile-based stress intervention group with feedback on demand or a waitlist control group. Self-report data were assessed at baseline, posttreatment (7 weeks), and 3-month follow-up. The primary outcome was perceived stress posttreatment (PSS-4). Secondary outcomes included mental health outcomes, modifiable risk and protective factors, and college-related outcomes. Subgroup analyses were conducted in students with clinically relevant symptoms of depression (Center for Epidemiological Studies’ Depression Scale >17). Results: A total of 106 participants (76.8%) indicated that they were first-time help-seekers, and 77.3% (intervention group: 58/75; waitlist control group: 58/75) showed clinically relevant depressive symptoms at baseline. Findings indicated significant effects of the intervention compared with the waitlist control group for stress (d=0.69; 95% CI 0.36-1.02), anxiety (d=0.76; 95% CI 0.43-1.09), depression (d=0.63; 95% CI 0.30-0.96), college-related productivity (d=0.33; 95% CI 0.01-0.65), academic work impairment (d=0.34; 95% CI 0.01-0.66), and other outcomes after 7 weeks (posttreatment). Response rates for stress symptoms were significantly higher for the intervention group (69%, 52/75) compared with the waitlist control group (35%, 26/75, P<.001; number needed to treat=2.89, 95% CI 2.01-5.08) at posttest (7 weeks). Effects were sustained at 3-month follow-up, and similar findings emerged in students with symptoms of depression. Conclusions: Internet- and mobile-based interventions could be an effective and cost-effective approach to reduce consequences of college-related stress and might potentially attract students with clinically relevant depression who would not otherwise seek help. Trial Registration: German Clinical Trial Register DRKS00010212; http://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00010212 (Archived by WebCite at http://www.webcitation.org/6w55Ewhjd) %M 29685870 %R 10.2196/jmir.9293 %U http://www.jmir.org/2018/4/e136/ %U https://doi.org/10.2196/jmir.9293 %U http://www.ncbi.nlm.nih.gov/pubmed/29685870 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 4 %P e145 %T Usage of a Digital Health Workplace Intervention Based on Socioeconomic Environment and Race: Retrospective Secondary Cross-Sectional Study %A Senecal,Conor %A Widmer,R Jay %A Bailey,Kent %A Lerman,Lilach O %A Lerman,Amir %+ Mayo Clinic, 200 1st St SW, Rochester, MN, 55905, United States, 1 507 255 1622, lerman.amir@mayo.edu %K race and ethnicity %K socioeconomic position %K computers %K health services research %K health disparities %D 2018 %7 23.04.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital health tools have been associated with improvement of cardiovascular disease (CVD) risk factors and outcomes; however, the differential use of these technologies among various ethnic and economic classes is not well known. Objective: To identify the effect of socioeconomic environment on usage of a digital health intervention. Methods: A retrospective secondary cross-sectional analysis of a workplace digital health tool use, in association with a change in intermediate markers of CVD, was undertaken over the course of one year in 26,188 participants in a work health program across 81 organizations in 42 American states between 2011 and 2014. Baseline demographic data for participants included age, sex, race, home zip code, weight, height, blood pressure, glucose, lipids, and hemoglobin A1c. Follow-up data was then obtained in 90-day increments for up to one year. Using publicly available data from the American Community Survey, we obtained the median income for each zip code as a marker for socioeconomic status via median household income. Digital health intervention usage was analyzed based on socioeconomic status as well as age, gender, and race. Results: The cohort was found to represent a wide sample of socioeconomic environments from a median income of US $11,000 to $171,000. As a whole, doubling of income was associated with 7.6% increase in log-in frequency. However, there were marked differences between races. Black participants showed a 40.5% increase and Hispanic participants showed a 57.8% increase in use with a doubling of income, compared to 3% for Caucasian participants. Conclusions: The current study demonstrated that socioeconomic data confirms no relevant relationship between socioeconomic environment and digital health intervention usage for Caucasian users. However, a strong relationship is present for black and Hispanic users. Thus, socioeconomic environment plays a prominent role only in minority groups that represent a high-risk group for CVD. This finding identifies a need for digital health apps that are effective in these high-risk groups. %M 29685862 %R 10.2196/jmir.8819 %U http://www.jmir.org/2018/4/e145/ %U https://doi.org/10.2196/jmir.8819 %U http://www.ncbi.nlm.nih.gov/pubmed/29685862 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 1 %N 1 %P e2 %T A Web-Based Intervention to Help Caregivers of Older Adults With Dementia and Multiple Chronic Conditions: Qualitative Study %A Ploeg,Jenny %A McAiney,Carrie %A Duggleby,Wendy %A Chambers,Tracey %A Lam,Annie %A Peacock,Shelley %A Fisher,Kathryn %A Forbes,Dorothy Anne %A Ghosh,Sunita %A Markle-Reid,Maureen %A Triscott,Jean %A Williams,Allison %+ School of Nursing, Faculty of Health Sciences, McMaster University, Health Sciences Centre, Room HSC 3N25C, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada, 1 905 525 9140 ext 22294, ploegj@mcmaster.ca %K Internet %K Web-based interventions %K qualitative research %K caregivers %K aged %K dementia %K multiple chronic conditions %D 2018 %7 23.04.2018 %9 Original Paper %J JMIR Aging %G English %X Background: Caregivers (ie, family members and friends) play a vital role in the ongoing care and well-being of community-living older persons with Alzheimer disease and related dementia in combination with multiple chronic conditions. However, they often do so to the detriment of their own physical, mental, and emotional health. Caregivers often experience multiple challenges in their caregiving roles and responsibilities. Recent evidence suggests that Web-based interventions have the potential to support caregivers by decreasing caregiver stress and burden. However, we know little about how Web-based supports help caregivers. Objective: The objectives of this paper were to describe (1) how the use of a self-administered, psychosocial, supportive, Web-based Transition Toolkit, My Tools 4 Care (MT4C), designed by atmist, Edmonton, Alberta, Canada, helped caregivers of older adults with Alzheimer disease and related dementia and multiple chronic conditions; (2) which features of MT4C caregivers found most and least beneficial; and (3) what changes would they would recommend making to MT4C. Methods: This study was part of a larger multisite mixed-methods pragmatic randomized controlled trial. The qualitative portion of the study and the focus of this paper used a qualitative descriptive design. Data collectors conducted semistructured, open-ended, telephone interviews with study participants who were randomly allocated to use MT4C for 3 months. All interviews were audio-taped and ranged from 20 to 40 min. Interviews were conducted at 1 and 3 months following a baseline interview. Qualitative content analysis was used to analyze collected data. Results: Fifty-six caregivers from Alberta and Ontario, Canada, participated in either one or both of the follow-up interviews (89 interviews in total). Caregivers explained that using MT4C (1) encouraged reflection; (2) encouraged sharing of caregiving experiences; (3) provided a source of information and education; (4) provided affirmation; and for some participants (5) did not help. Caregivers also described features of MT4C that they found most and least beneficial and changes they would recommend making to MT4C. Conclusions: Study results indicate that a self-administered psychosocial supportive Web-based resource helps caregivers of community-dwelling older adults with Alzheimer disease and related dementia and multiple chronic conditions with their complex caregiving roles and responsibilities. The use of MT4C also helped caregivers in identifying supports for caring, caring for self, and planning for future caregiving roles and responsibilities. Caregivers shared important recommendations for future development of Web-based supports. %M 31518230 %R 10.2196/aging.8475 %U http://aging.jmir.org/2018/1/e2/ %U https://doi.org/10.2196/aging.8475 %U http://www.ncbi.nlm.nih.gov/pubmed/31518230 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 4 %P e147 %T Comparative Effectiveness of a Technology-Facilitated Depression Care Management Model in Safety-Net Primary Care Patients With Type 2 Diabetes: 6-Month Outcomes of a Large Clinical Trial %A Wu,Shinyi %A Ell,Kathleen %A Jin,Haomiao %A Vidyanti,Irene %A Chou,Chih-Ping %A Lee,Pey-Jiuan %A Gross-Schulman,Sandra %A Sklaroff,Laura Myerchin %A Belson,David %A Nezu,Arthur M %A Hay,Joel %A Wang,Chien-Ju %A Scheib,Geoffrey %A Di Capua,Paul %A Hawkins,Caitlin %A Liu,Pai %A Ramirez,Magaly %A Wu,Brian W %A Richman,Mark %A Myers,Caitlin %A Agustines,Davin %A Dasher,Robert %A Kopelowicz,Alex %A Allevato,Joseph %A Roybal,Mike %A Ipp,Eli %A Haider,Uzma %A Graham,Sharon %A Mahabadi,Vahid %A Guterman,Jeffrey %+ Suzanne Dworak-Peck School of Social Work, University of Southern California, 1150 S Olive Street, Suite 1400, Los Angeles, CA, 90015, United States, 1 2138216442, shinyiwu@usc.edu %K primary care %K disease management %K depression %K diabetes mellitus %K health information technology %K telemedicine %K comparative effectiveness research %K propensity score %K population health %K patient reported outcome measures %D 2018 %7 23.04.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Comorbid depression is a significant challenge for safety-net primary care systems. Team-based collaborative depression care is effective, but complex system factors in safety-net organizations impede adoption and result in persistent disparities in outcomes. Diabetes-Depression Care-management Adoption Trial (DCAT) evaluated whether depression care could be significantly improved by harnessing information and communication technologies to automate routine screening and monitoring of patient symptoms and treatment adherence and allow timely communication with providers. Objective: The aim of this study was to compare 6-month outcomes of a technology-facilitated care model with a usual care model and a supported care model that involved team-based collaborative depression care for safety-net primary care adult patients with type 2 diabetes. Methods: DCAT is a translational study in collaboration with Los Angeles County Department of Health Services, the second largest safety-net care system in the United States. A comparative effectiveness study with quasi-experimental design was conducted in three groups of adult patients with type 2 diabetes to compare three delivery models: usual care, supported care, and technology-facilitated care. Six-month outcomes included depression and diabetes care measures and patient-reported outcomes. Comparative treatment effects were estimated by linear or logistic regression models that used generalized propensity scores to adjust for sampling bias inherent in the nonrandomized design. Results: DCAT enrolled 1406 patients (484 in usual care, 480 in supported care, and 442 in technology-facilitated care), most of whom were Hispanic or Latino and female. Compared with usual care, both the supported care and technology-facilitated care groups were associated with significant reduction in depressive symptoms measured by scores on the 9-item Patient Health Questionnaire (least squares estimate, LSE: usual care=6.35, supported care=5.05, technology-facilitated care=5.16; P value: supported care vs usual care=.02, technology-facilitated care vs usual care=.02); decreased prevalence of major depression (odds ratio, OR: supported care vs usual care=0.45, technology-facilitated care vs usual care=0.33; P value: supported care vs usual care=.02, technology-facilitated care vs usual care=.007); and reduced functional disability as measured by Sheehan Disability Scale scores (LSE: usual care=3.21, supported care=2.61, technology-facilitated care=2.59; P value: supported care vs usual care=.04, technology-facilitated care vs usual care=.03). Technology-facilitated care was significantly associated with depression remission (technology-facilitated care vs usual care: OR=2.98, P=.04); increased satisfaction with care for emotional problems among depressed patients (LSE: usual care=3.20, technology-facilitated care=3.70; P=.05); reduced total cholesterol level (LSE: usual care=176.40, technology-facilitated care=160.46; P=.01); improved satisfaction with diabetes care (LSE: usual care=4.01, technology-facilitated care=4.20; P=.05); and increased odds of taking an glycated hemoglobin test (technology-facilitated care vs usual care: OR=3.40, P<.001). Conclusions: Both the technology-facilitated care and supported care delivery models showed potential to improve 6-month depression and functional disability outcomes. The technology-facilitated care model has a greater likelihood to improve depression remission, patient satisfaction, and diabetes care quality. %M 29685872 %R 10.2196/jmir.7692 %U http://www.jmir.org/2018/4/e147/ %U https://doi.org/10.2196/jmir.7692 %U http://www.ncbi.nlm.nih.gov/pubmed/29685872 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 4 %P e10143 %T Trajectories of 12-Month Usage Patterns for Two Smoking Cessation Websites: Exploring How Users Engage Over Time %A Bricker,Jonathan B %A Sridharan,Vasundhara %A Zhu,Yifan %A Mull,Kristin E %A Heffner,Jaimee L %A Watson,Noreen L %A McClure,Jennifer B %A Di,Chongzhi %+ Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA, 98109, United States, 1 2066675074, jbricker@fredhutch.org %K engagement %K trajectories %K eHealth %K websites %K tobacco %K smoking %K acceptance and commitment therapy %K smokefree.gov %K patient participation %K telemedicine %K tobacco use cessation %K smoking cessation %D 2018 %7 20.04.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Little is known about how individuals engage with electronic health (eHealth) interventions over time and whether this engagement predicts health outcomes. Objective: The objectives of this study, by using the example of a specific type of eHealth intervention (ie, websites for smoking cessation), were to determine (1) distinct groups of log-in trajectories over a 12-month period, (2) their association with smoking cessation, and (3) baseline user characteristics that predict trajectory group membership. Methods: We conducted a functional clustering analysis of 365 consecutive days of log-in data from both arms of a large (N=2637) randomized trial of 2 website interventions for smoking cessation (WebQuit and Smokefree), with a primary outcome of 30-day point prevalence smoking abstinence at 12 months. We conducted analyses for each website separately. Results: A total of 3 distinct trajectory groups emerged for each website. For WebQuit, participants were clustered into 3 groups: 1-week users (682/1240, 55.00% of the sample), 5-week users (399/1240, 32.18%), and 52-week users (159/1240, 12.82%). Compared with the 1-week users, the 5- and 52-week users had 57% higher odds (odds ratio [OR] 1.57, 95% CI 1.13-2.17; P=.007) and 124% higher odds (OR 2.24, 95% CI 1.45-3.43; P<.001), respectively, of being abstinent at 12 months. Smokefree users were clustered into 3 groups: 1-week users (645/1309, 49.27% of the sample), 4-week users (395/1309, 30.18%), and 5-week users (269/1309, 20.55%). Compared with the 1-week users, 5-week users (but not 4-week users; P=.99) had 48% higher odds (OR 1.48, 95% CI 1.05-2.07; P=.02) of being abstinent at 12 months. In general, the WebQuit intervention had a greater number of weekly log-ins within each of the 3 trajectory groups as compared with those of the Smokefree intervention. Baseline characteristics associated with trajectory group membership varied between websites. Conclusions: Patterns of 1-, 4-, and 5-week usage of websites may be common for how people engage in eHealth interventions. The 5-week usage of either website, and 52-week usage only of WebQuit, predicted a higher odds of quitting smoking. Strategies to increase eHealth intervention engagement for 4 more weeks (ie, from 1 week to 5 weeks) could be highly cost effective. Trial Registration: ClinicalTrials.gov NCT01812278; https://www.clinicaltrials.gov/ct2/show/NCT01812278 (Archived by WebCite at http://www.webcitation.org/6yPO2OIKR) %M 29678799 %R 10.2196/10143 %U http://www.jmir.org/2018/4/e10143/ %U https://doi.org/10.2196/10143 %U http://www.ncbi.nlm.nih.gov/pubmed/29678799 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 2 %P e19 %T Feasibility and Acceptability of a Web-Based Treatment with Telephone Support for Postpartum Women With Anxiety: Randomized Controlled Trial %A Ashford,Miriam T %A Olander,Ellinor K %A Rowe,Heather %A Fisher,Jane RW %A Ayers,Susan %+ Centre for Maternal and Child Health Research, School of Health Sciences, City, University of London, 1 Myddleton Street, London, EC1R 1UW, United Kingdom, 44 207040 ext 5775, miriam.ashford@city.ac.uk %K anxiety %K mental health %K postpartum period %K treatment %K Internet %K randomized controlled trial %D 2018 %7 20.04.2018 %9 Original Paper %J JMIR Ment Health %G English %X Background: Postpartum anxiety can have adverse effects on the mother and child if left untreated. Time constraints and stigma are common barriers to postpartum treatment. Web-based treatments offer potential flexibility and anonymity. What Am I Worried About (WaWa) is a self-guided treatment based on cognitive-behavioral and mindfulness principles for women experiencing postpartum anxiety. WaWa was developed in Australia and consists of 9 modules with optional weekly telephone support. WaWa was adapted to a Web-based version for use in England (Internet-based What Am I Worried About, iWaWa). Objective: This study aimed to investigate the feasibility (engagement and usability) and acceptability (usefulness, satisfaction, and helpfulness) of iWaWa among English postpartum women with anxiety. Methods: Postpartum (<12 months) women with mild-to-severe anxiety were recruited anonymously via social media during an 8-week period. Participants were randomized to the iWaWa treatment (8 weeks) or wait-list control group. Treatment and study feasibility and acceptability were assessed after the treatment, and anxiety symptoms were assessed at baseline, 8 weeks postrandomization, and 12 weeks postrandomization (treatment group only) using Web-based questionnaires. Semistructured telephone interviews were carried out after the treatment period for a more in-depth exploration of treatment acceptability and feasibility. Results: A total of 89 eligible women were recruited through social media and randomized into the treatment (n=46) or wait-list control group (n=43). Women were predominantly Caucasian, well-educated, married, on maternity leave, first-time mothers and reported moderate levels of anxiety. Dropout rates were high, especially in the treatment group (treatment: 82%, 38/46; wait-list control: 51%, 22/43). A total of 26 women started iWaWa with only 2 women completing all 9 modules. Quantitative and qualitative data suggest iWaWa was experienced as generally useful and helpful. Participants enjoyed iWaWa’s accessibility, anonymity, and weekly reminders, as well as the introduction to the principles of cognitive-behavioral therapy (CBT) and mindfulness. However, iWaWa was also experienced as not user-friendly enough, too long, and not smartphone-friendly. Parts of the content were experienced as not always relevant and appropriate. Participants felt that iWaWa could be improved by having it in a smartphone app format and by making the content more concise and inclusive of different parenting styles. Conclusions: Despite interest in iWaWa, the results suggest that both the study and iWaWa were not feasible in the current format. However, this first trial provides useful evidence about treatment format and content preferences that can inform iWaWa’s future development, as well as research and development of Web-based postpartum anxiety treatments, in general, to optimize adherence. Trial Registration: ClinicalTrials.gov NCT02434406; https://clinicaltrials.gov/ct2/show/NCT02434406 (Archived by WebCite at http://www.webcitation.org/6xTq7Bwmd) %M 29678804 %R 10.2196/mental.9106 %U http://mental.jmir.org/2018/2/e19/ %U https://doi.org/10.2196/mental.9106 %U http://www.ncbi.nlm.nih.gov/pubmed/29678804 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 4 %P e90 %T Assessing Therapeutic Alliance in the Context of mHealth Interventions for Mental Health Problems: Development of the Mobile Agnew Relationship Measure (mARM) Questionnaire %A Berry,Katherine %A Salter,Amy %A Morris,Rohan %A James,Susannah %A Bucci,Sandra %+ Division of Psychology and Mental Health, School of Health Sciences, University of Manchester, Oxford Road, Manchester, M139PL, United Kingdom, 44 1613060422, katherine.berry@manchester.ac.uk %K mobile health %K health care provider %K digital interventions %K therapeutic alliance %K mental health %K measure development %D 2018 %7 19.04.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital health interventions in the form of smartphone apps aim to improve mental health and enable people access to support as and when needed without having to face the stigma they may experience in accessing services. If we are to evaluate mobile health (mHealth) apps and advance scientific understanding, we also need tools to help us understand in what ways mHealth interventions are effective or not. The concept of therapeutic alliance, a measure of the quality of the relationship between a health care provider and a service user, is a key factor in explaining the effects of mental health interventions. The Agnew Relationship Measure (ARM) is a well-validated measure of therapeutic alliance in face-to-face therapy. Objective: This study presented the first attempt to (1) explore service users’ views of the concept of relationship within mHealth mental health interventions and (2) adapt a well-validated face-to-face measure of therapeutic alliance, the Agnew Relationship Measure (ARM), for use with mHealth interventions. Methods: In stage 1, we interviewed 9 mental health service users about the concept of therapeutic alliance in the context of a digital health intervention and derived key themes from interview transcripts using thematic analysis. In stage 2, we used rating scales and open-ended questions to elicit views from 14 service users and 10 mental health staff about the content and face validity of the scale, which replaced the word “therapist” with the word “app.” In stage 3, we used the findings from stages 1 and 2 to adapt the measure with the support of a decision-making algorithm about which items to drop, retain, or adapt. Results: Findings suggested that service users do identify relationship concepts when thinking about mHealth interventions, including forming a bond with an app and the ability to be open with an app. However, there were key differences between relationships with health professionals and relationships with apps. For example, apps were not as tailored and responsive to each person’s unique needs. Furthermore, apps were not capable of portraying uniquely human-like qualities such as friendliness, collaboration, and agreement. We made a number of changes to the ARM that included revising 16 items; removing 4 items due to lack of suitable alternatives; and adding 1 item to capture a key theme derived from stage 1 of the study (“The app is like having a member of my care team in my pocket”). Conclusions: This study introduces the mHealth version of the ARM, the mARM, that has good face and content validity. We encourage researchers to include this easy-to-use tool in digital health intervention studies to gather further data about its psychometric properties and advance our understanding of how therapeutic alliance influences the efficacy of mHealth interventions. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 34966555; http://www.isrctn.com/ISRCTN34966555 (Archived by WebCite at http://www.webcitation.org/6ymBVwKif) %M 29674307 %R 10.2196/jmir.8252 %U http://www.jmir.org/2018/4/e90/ %U https://doi.org/10.2196/jmir.8252 %U http://www.ncbi.nlm.nih.gov/pubmed/29674307 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 4 %P e133 %T Development of an Internet-Administered Cognitive Behavior Therapy Program (ENGAGE) for Parents of Children Previously Treated for Cancer: Participatory Action Research Approach %A Wikman,Anna %A Kukkola,Laura %A Börjesson,Helene %A Cernvall,Martin %A Woodford,Joanne %A Grönqvist,Helena %A von Essen,Louise %+ Clinical Psychology in Healthcare, Department of Women's and Children's Health, Uppsala University, Uppsala University Hospital, Uppsala, 75185, Sweden, 46 186110000, anna.wikman@kbh.uu.se %K cognitive therapy %K psychology, clinical %K e-therapy %K community participation %K Sweden %D 2018 %7 18.04.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Parenting a child through cancer is a distressing experience, and a subgroup of parents report negative long-term psychological consequences years after treatment completion. However, there is a lack of evidence-based psychological interventions for parents who experience distress in relation to a child’s cancer disease after end of treatment. Objective: One aim of this study was to develop an internet-administered, cognitive behavior therapy–based, psychological, guided, self-help intervention (ENGAGE) for parents of children previously treated for cancer. Another aim was to identify acceptable procedures for future feasibility and efficacy studies testing and evaluating the intervention. Methods: Participatory action research methodology was used. The study included face-to-face workshops and related Web-based exercises. A total of 6 parents (4 mothers, 2 fathers) of children previously treated for cancer were involved as parent research partners. Moreover, 2 clinical psychologists were involved as expert research partners. Research partners and research group members worked collaboratively throughout the study. Data were analyzed iteratively using written summaries of the workshops and Web-based exercises parallel to data collection. Results: A 10-week, internet-administered, cognitive behavior therapy–based, psychological, guided, self-help intervention (ENGAGE) was developed in collaboration with parent research partners and expert research partners. The content of the intervention, mode and frequency of e-therapist support, and the individualized approach for feedback were modified based on the research partner input. Shared solutions were reached regarding the type and timing of support from an e-therapist (eg, initial video or telephone call, multiple methods of e-therapist contact), duration and timing of intervention (eg, 10 weeks, 30-min assessments), and the removal of unnecessary support functions (eg, removal of chat and forum functions). Preferences for study procedures in future studies testing and evaluating the intervention were discussed; consensus was not reached for all aspects. Conclusions: To the best of our knowledge, this study is the first use of a participatory action research approach to develop a psychological intervention for parents of children previously treated for cancer and to identify acceptable study procedures. Involvement of parents with lived experience was vital in the development of a potentially relevant and acceptable intervention for this population. %M 29669710 %R 10.2196/jmir.9457 %U http://www.jmir.org/2018/4/e133/ %U https://doi.org/10.2196/jmir.9457 %U http://www.ncbi.nlm.nih.gov/pubmed/29669710 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 4 %P e122 %T Physical Activity, Sedentary Behavior, and Diet-Related eHealth and mHealth Research: Bibliometric Analysis %A Müller,Andre Matthias %A Maher,Carol A %A Vandelanotte,Corneel %A Hingle,Melanie %A Middelweerd,Anouk %A Lopez,Michael L %A DeSmet,Ann %A Short,Camille E %A Nathan,Nicole %A Hutchesson,Melinda J %A Poppe,Louise %A Woods,Catherine B %A Williams,Susan L %A Wark,Petra A %+ Domain: Health Systems & Behavioural Sciences, Saw Swee Hock School of Public Healh, National University of Singapore, Tahir Foundation Building, 12 Science Drive, #10-01, Singapore, 117549, Singapore, 65 82997548, ephamm@nus.edu.sg %K science %K telemedicine %K exercise %K health behavior %K health resources %K food %K publications %K movement %K trends %K Internet %D 2018 %7 18.04.2018 %9 Review %J J Med Internet Res %G English %X Background: Electronic health (eHealth) and mobile health (mHealth) approaches to address low physical activity levels, sedentary behavior, and unhealthy diets have received significant research attention. However, attempts to systematically map the entirety of the research field are lacking. This gap can be filled with a bibliometric study, where publication-specific data such as citations, journals, authors, and keywords are used to provide a systematic overview of a specific field. Such analyses will help researchers better position their work. Objective: The objective of this review was to use bibliometric data to provide an overview of the eHealth and mHealth research field related to physical activity, sedentary behavior, and diet. Methods: The Web of Science (WoS) Core Collection was searched to retrieve all existing and highly cited (as defined by WoS) physical activity, sedentary behavior, and diet related eHealth and mHealth research papers published in English between January 1, 2000 and December 31, 2016. Retrieved titles were screened for eligibility, using the abstract and full-text where needed. We described publication trends over time, which included journals, authors, and countries of eligible papers, as well as their keywords and subject categories. Citations of eligible papers were compared with those expected based on published data. Additionally, we described highly-cited papers of the field (ie, top ranked 1%). Results: The search identified 4805 hits, of which 1712 (including 42 highly-cited papers) were included in the analyses. Publication output increased on an average of 26% per year since 2000, with 49.00% (839/1712) of papers being published between 2014 and 2016. Overall and throughout the years, eHealth and mHealth papers related to physical activity, sedentary behavior, and diet received more citations than expected compared with papers in the same WoS subject categories. The Journal of Medical Internet Research published most papers in the field (9.58%, 164/1712). Most papers originated from high-income countries (96.90%, 1659/1717), in particular the United States (48.83%, 836/1712). Most papers were trials and studied physical activity. Beginning in 2013, research on Generation 2 technologies (eg, smartphones, wearables) sharply increased, while research on Generation 1 (eg, text messages) technologies increased at a reduced pace. Reviews accounted for 20 of the 42 highly-cited papers (n=19 systematic reviews). Social media, smartphone apps, and wearable activity trackers used to encourage physical activity, less sedentary behavior, and/or healthy eating were the focus of 14 highly-cited papers. Conclusions: This study highlighted the rapid growth of the eHealth and mHealth physical activity, sedentary behavior, and diet research field, emphasized the sizeable contribution of research from high-income countries, and pointed to the increased research interest in Generation 2 technologies. It is expected that the field will grow and diversify further and that reviews and research on most recent technologies will continue to strongly impact the field. %M 29669703 %R 10.2196/jmir.8954 %U http://www.jmir.org/2018/4/e122/ %U https://doi.org/10.2196/jmir.8954 %U http://www.ncbi.nlm.nih.gov/pubmed/29669703 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 4 %P e84 %T Findings of the Chronic Obstructive Pulmonary Disease-Sitting and Exacerbations Trial (COPD-SEAT) in Reducing Sedentary Time Using Wearable and Mobile Technologies With Educational Support: Randomized Controlled Feasibility Trial %A Orme,Mark W %A Weedon,Amie E %A Saukko,Paula M %A Esliger,Dale W %A Morgan,Mike D %A Steiner,Michael C %A Downey,John W %A Sherar,Lauren B %A Singh,Sally J %+ Centre for Exercise and Rehabilitation Science, National Institute for Health Research Leicester Biomedical Research Centre - Respiratory, Glenfield Hospital, Groby Road, Leicester, LE39QP, United Kingdom, 44 1162502762, mark.orme@uhl-tr.nhs.uk %K chronic obstructive pulmonary disease %K feasibility %K fitness trackers %K intervention %K physical activity %K sedentary lifestyle %K sedentary time %K self-monitoring %K wearable electronic devices %D 2018 %7 11.04.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Targeting sedentary time post exacerbation may be more relevant than targeting structured exercise for individuals with chronic obstructive pulmonary disease. Focusing interventions on sitting less and moving more after an exacerbation may act as a stepping stone to increase uptake to pulmonary rehabilitation. Objective: The aim of this paper was to conduct a randomized trial examining trial feasibility and the acceptability of an education and self-monitoring intervention using wearable technology to reduce sedentary behavior for individuals with chronic obstructive pulmonary disease admitted to hospital for an acute exacerbation. Methods: Participants were recruited and randomized in hospital into 3 groups, with the intervention lasting 2 weeks post discharge. The Education group received verbal and written information about reducing their time in sedentary behavior, sitting face-to-face with a study researcher. The Education+Feedback group received the same education component along with real-time feedback on their sitting time, stand-ups, and steps at home through a waist-worn inclinometer linked to an app. Patients were shown how to use the technology by the same study researcher. The inclinometer also provided vibration prompts to encourage movement at patient-defined intervals of time. Patients and health care professionals involved in chronic obstructive pulmonary disease exacerbation care were interviewed to investigate trial feasibility and acceptability of trial design and methods. Main quantitative outcomes of trial feasibility were eligibility, uptake, and retention, and for acceptability, were behavioral responses to the vibration prompts. Results: In total, 111 patients were approached with 33 patients recruited (11 Control, 10 Education, and 12 Education+Feedback). Retention at 2-week follow-up was 52% (17/33; n=6 for Control, n=3 for Education, and n=8 for Education+Feedback). No study-related adverse events occurred. Collectively, patients responded to 106 out of 325 vibration prompts from the waist-worn inclinometer (32.62%). Within 5 min of the prompt, 41% of responses occurred, with patients standing for a mean 1.4 (SD 0.8) min and walking for 0.4 (SD 0.3) min (21, SD 11, steps). Interviews indicated that being unwell and overwhelmed after an exacerbation was the main reason for not engaging with the intervention. Health care staff considered reducing sedentary behavior potentially attractive for patients but suggested starting the intervention as an inpatient. Conclusions: Although the data support that it was feasible to conduct the trial, modifications are needed to improve participant retention. The intervention was acceptable to most patients and health care professionals. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 13790881; http://www.isrctn.com/ISRCTN13790881 (Archived by WebCite at http://www.webcitation.org/6xmnRGjFf) %M 29643055 %R 10.2196/mhealth.9398 %U http://mhealth.jmir.org/2018/4/e84/ %U https://doi.org/10.2196/mhealth.9398 %U http://www.ncbi.nlm.nih.gov/pubmed/29643055 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 4 %P e85 %T Mobile Breast Cancer e-Support Program for Chinese Women With Breast Cancer Undergoing Chemotherapy (Part 1): Qualitative Study of Women’s Perceptions %A Zhu,Jiemin %A Ebert,Lyn %A Guo,Dongmei %A Yang,Sumei %A Han,Qiuying %A Chan,Sally Wai-Chi %+ Nursing Department, Medical School, Xiamen University, Room 208, Alice Building,, Xiangan Nan Road, Xiangan District, Xiamen, 361102, Fujian Province, China, 86 15960212649, jiemin.zhu@uon.edu.au %K mobile app %K breast cancer %K chemotherapy %D 2018 %7 11.04.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Women with breast cancer undergoing chemotherapy experience difficulty in accessing adequate cancer care in China. Mobile apps have the potential to provide easily accessible support for these women. However, there remains a paucity of randomized controlled trials to evaluate the effectiveness of app-based programs targeting specifically women with breast cancer undergoing chemotherapy. Moreover, women’s perceptions and experiences related to using and interacting within the app-based program have rarely been reported. Therefore, an app-based Breast Cancer e-Support program was developed and evaluated using a randomized controlled trial. Based on the incorporation of Bandura’s self-efficacy and social exchange theory, Breast Cancer e-Support program lasted for 12 weeks covering 4 cycles of chemotherapy and had 4 components: (1) a Learning forum, (2) a Discussion forum, (3) an Ask-the-Expert forum, and (4) a Personal Stories forum. Objective: As a part of the randomized controlled trial, the aim of this study was to explore the participants’ perception of Breast Cancer e-Support program, its strengths and weaknesses, and suggestions to improve the program. Methods: A descriptive qualitative study was employed. Thirteen women with breast cancer from 2 university-affiliated hospitals in China, who were randomly allocated to the Breast Cancer e-Support program in the randomized controlled trial, were interviewed from November 2016 to February 2017. Purposive sampling was used based on women’s scores of self-efficacy after the completion of the intervention. Inductive content analysis was used to analyze the transcripts, allowing the categories and subcategories to flow from the data. Results: The qualitative interviews revealed that participants perceived the Breast Cancer e-Support program to be helpful in enhancing knowledge, improving confidence level, and promoting emotional well-being. Women also identified access to tailored advice from experts and convenience as the benefits of this program. Physical or psychological health status, stigma related with breast cancer, and app instability were mentioned as the challenges to engagement. Suggestions for improvement included adding message reminders to prompt instant communication and search engine to locate information quickly, supplementing more interesting and practical knowledge, updating the information more often, and quickening the responses to women’s questions. The participants recommended the Breast Cancer e-Support program to be incorporated as routine care to support women during chemotherapy. Conclusions: This study demonstrates the potential of the Breast Cancer e-Support program to support women during chemotherapy. Future app-based programs should apply a family-centered approach and provide more support on stigma associated with the disease to encourage engagement with the app. Suggestions of improvement regarding the design, content, and operation of the app-based intervention should be addressed in future studies. It is promising to incorporate the Breast Cancer e-Support program into routine care to generalize the benefits. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12616000639426; http://www.ANZCTR.org.au/ ACTRN12616000639426.aspx (Archived by WebCite at http://www.webcitation.org/6v1n9hGZq) %M 29643056 %R 10.2196/mhealth.9311 %U http://mhealth.jmir.org/2018/4/e85/ %U https://doi.org/10.2196/mhealth.9311 %U http://www.ncbi.nlm.nih.gov/pubmed/29643056 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 4 %P e144 %T Exploring the Role of In-Person Components for Online Health Behavior Change Interventions: Can a Digital Person-to-Person Component Suffice? %A Santarossa,Sara %A Kane,Deborah %A Senn,Charlene Y %A Woodruff,Sarah J %+ Department of Kinesiology, University of Windsor, 401 Sunset Avenue, Windsor, ON, N9B 3P4, Canada, 1 5198198061, santaros@uwindsor.ca %K digital person-to-person %K in-person %K online intervention %K behavior change %K health, digital media %K health care %D 2018 %7 11.04.2018 %9 Viewpoint %J J Med Internet Res %G English %X The growth of the digital environment provides tremendous opportunities to revolutionize health behavior change efforts. This paper explores the use of Web-based, mobile, and social media health behavior change interventions and determines whether there is a need for a face-to-face or an in-person component. It is further argued that that although in-person components can be beneficial for online interventions, a digital person-to-person component can foster similar results while dealing with challenges faced by traditional intervention approaches. Using a digital person-to-person component is rooted in social and behavioral theories such as the theory of reasoned action, and the social cognitive theory, and further justified by the human support constructs of the model of supportive accountability. Overall, face-to-face and online behavior change interventions have their respective advantages and disadvantages and functions, yet both serve important roles. It appears that it is in fact human support that is the most important component in the effectiveness and adherence of both face-to-face and online behavior change interventions, and thoughtfully introducing a digital person-to-person component, to replace face-to-face interactions, can provide the needed human support while diminishing the barriers of in-person meetings. The digital person-to-person component must create accountability, generate opportunities for tailored feedback, and create social support to successfully create health behavior change. As the popularity of the online world grows, and the interest in using the digital environment for health behavior change interventions continues to be embraced, further research into not only the use of online interventions, but the use of a digital person-to-person component, must be explored. %M 29643048 %R 10.2196/jmir.8480 %U http://www.jmir.org/2018/4/e144/ %U https://doi.org/10.2196/jmir.8480 %U http://www.ncbi.nlm.nih.gov/pubmed/29643048 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 2 %P e29 %T Engagement With a Trauma Recovery Internet Intervention Explained With the Health Action Process Approach (HAPA): Longitudinal Study %A Yeager,Carolyn M %A Shoji,Kotaro %A Luszczynska,Aleksandra %A Benight,Charles C %+ Department of Psychology, University of Colorado Colorado Springs, 1420 Austin Bluffs Pkwy, Colorado Springs, CO, 80918, United States, 1 719 255 4661, cyeager@uccs.edu %K electronic health (eHealth) %K engagement %K trauma %K stress disorders, post-traumatic %K PTSD %K Health Action Process Approach (HAPA) %K outcome expectations %K internet %K digital health intervention %D 2018 %7 10.04.2018 %9 Original Paper %J JMIR Ment Health %G English %X Background: There has been a growing trend in the delivery of mental health treatment via technology (ie, electronic health, eHealth). However, engagement with eHealth interventions is a concern, and theoretically based research in this area is sparse. Factors that influence engagement are poorly understood, especially in trauma survivors with symptoms of posttraumatic stress. Objective: The aim of this study was to examine engagement with a trauma recovery eHealth intervention using the Health Action Process Approach theoretical model. Outcome expectancy, perceived need, pretreatment self-efficacy, and trauma symptoms influence the formation of intentions (motivational phase), followed by planning, which mediates the translation of intentions into engagement (volitional phase). We hypothesized the mediational effect of planning would be moderated by level of treatment self-efficacy. Methods: Trauma survivors from around the United States used the eHealth intervention for 2 weeks. We collected baseline demographic, social cognitive predictors, and distress symptoms and measured engagement subjectively and objectively throughout the intervention. Results: The motivational phase model explained 48% of the variance, and outcome expectations (beta=.36), perceived need (beta=.32), pretreatment self-efficacy (beta=.13), and trauma symptoms (beta=.21) were significant predictors of intention (N=440). In the volitional phase, results of the moderated mediation model indicated for low levels of treatment self-efficacy, planning mediated the effects of intention on levels of engagement (B=0.89, 95% CI 0.143-2.605; N=115). Conclusions: Though many factors can affect engagement, these results offer a theoretical framework for understanding engagement with an eHealth intervention. This study highlighted the importance of perceived need, outcome expectations, self-efficacy, and baseline distress symptoms in the formation of intentions to use the intervention. For those low in treatment self-efficacy, planning may play an important role in the translation of intentions into engagement. Results of this study may help bring some clarification to the question of what makes eHealth interventions work. %M 29636323 %R 10.2196/mental.9449 %U http://mental.jmir.org/2018/2/e29/ %U https://doi.org/10.2196/mental.9449 %U http://www.ncbi.nlm.nih.gov/pubmed/29636323 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 3 %P e106 %T Just-in-Time Feedback in Diet and Physical Activity Interventions: Systematic Review and Practical Design Framework %A Schembre,Susan M %A Liao,Yue %A Robertson,Michael C %A Dunton,Genevieve Fridlund %A Kerr,Jacqueline %A Haffey,Meghan E %A Burnett,Taylor %A Basen-Engquist,Karen %A Hicklen,Rachel S %+ Department of Behavioral Science, Division of Cancer Control and Population Sciences, The University of Texas MD Anderson Cancer Center, Unit 1330, PO Box 301439, Houston, TX, 77230-1439, United States, 1 713 563 5858, sschembre@mdanderson.org %K health behavior %K diet %K exercise %K task performance and analysis %K Internet %K mHealth %K accelerometer %K activity monitor %K self-tracking %K wearable sensors %D 2018 %7 22.03.2018 %9 Review %J J Med Internet Res %G English %X Background: The integration of body-worn sensors with mobile devices presents a tremendous opportunity to improve just-in-time behavioral interventions by enhancing bidirectional communication between investigators and their participants. This approach can be used to deliver supportive feedback at critical moments to optimize the attainment of health behavior goals. Objective: The goals of this systematic review were to summarize data on the content characteristics of feedback messaging used in diet and physical activity (PA) interventions and to develop a practical framework for designing just-in-time feedback for behavioral interventions. Methods: Interventions that included just-in-time feedback on PA, sedentary behavior, or dietary intake were eligible for inclusion. Feedback content and efficacy data were synthesized descriptively. Results: The review included 31 studies (15/31, 48%, targeting PA or sedentary behavior only; 13/31, 42%, targeting diet and PA; and 3/31, 10%, targeting diet only). All studies used just-in-time feedback, 30 (97%, 30/31) used personalized feedback, and 24 (78%, 24/31) used goal-oriented feedback, but only 5 (16%, 5/31) used actionable feedback. Of the 9 studies that tested the efficacy of providing feedback to promote behavior change, 4 reported significant improvements in health behavior. In 3 of these 4 studies, feedback was continuously available, goal-oriented, or actionable. Conclusions: Feedback that was continuously available, personalized, and actionable relative to a known behavioral objective was prominent in intervention studies with significant behavior change outcomes. Future research should determine whether all or some of these characteristics are needed to optimize the effect of feedback in just-in-time interventions. %M 29567638 %R 10.2196/jmir.8701 %U http://www.jmir.org/2018/3/e106/ %U https://doi.org/10.2196/jmir.8701 %U http://www.ncbi.nlm.nih.gov/pubmed/29567638 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 3 %P e91 %T Evaluating a Web-Based Social Anxiety Intervention Among University Students: Randomized Controlled Trial %A McCall,Hugh Cameron %A Richardson,Chris G %A Helgadottir,Fjola Dogg %A Chen,Frances S %+ Department of Psychology, University of British Columbia, 3521-2136 West Mall, Vancouver, BC, V6T 1Z4, Canada, 1 604 822 2549, frances.chen@psych.ubc.ca %K social anxiety %K clinical trial %K internet %K cognitive behavior therapy %D 2018 %7 21.03.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Treatment rates for social anxiety, a prevalent and potentially debilitating condition, remain among the lowest of all major mental disorders today. Although computer-delivered interventions are well poised to surmount key barriers to the treatment of social anxiety, most are only marginally effective when delivered as stand-alone treatments. A new, Web-based cognitive behavioral therapy (CBT) intervention called Overcome Social Anxiety was recently created to address the limitations of prior computer-delivered interventions. Users of Overcome Social Anxiety are self-directed through various CBT modules incorporating cognitive restructuring and behavioral experiments. The intervention is personalized to each user’s symptoms, and automatic email reminders and time limits are used to encourage adherence. Objective: The purpose of this study was to conduct a randomized controlled trial to investigate the effectiveness of Overcome Social Anxiety in reducing social anxiety symptoms in a nonclinical sample of university students. As a secondary aim, we also investigated whether Overcome Social Anxiety would increase life satisfaction in this sample. Methods: Following eligibility screening, participants were randomly assigned to a treatment condition or a wait-list control condition. Only those assigned to the treatment condition were given access to Overcome Social Anxiety; they were asked to complete the program within 4 months. The social interaction anxiety scale (SIAS), the fear of negative evaluation scale (FNE), and the quality of life enjoyment and satisfaction questionnaire—short form (Q-LES-Q-SF) were administered to participants from both conditions during baseline and 4-month follow-up lab visits. Results: Over the course of the study, participants assigned to the treatment condition experienced a significant reduction in social anxiety (SIAS: P<.001, Cohen d=0.72; FNE: P<.001, Cohen d=0.82), whereas those assigned to the control condition did not (SIAS: P=.13, Cohen d=0.26; FNE: P=.40, Cohen d=0.14). Additionally, a direct comparison of the average change in social anxiety in the 2 conditions over the course of the study showed that those assigned to the treatment condition experienced significantly more improvement than those assigned to the control condition (SIAS: P=.03, Cohen d=0.56; FNE: P=.001, Cohen d=0.97). Although participants assigned to the treatment condition experienced a slight increase in life satisfaction, as measured by Q-LES-Q-SF scores, and those assigned to the control condition experienced a slight decrease, these changes were not statistically significant (treatment: P=.35, Cohen d=−0.18; control: P=.30, Cohen d=0.18). Conclusions: Our findings indicate that Overcome Social Anxiety is an effective intervention for treating symptoms of social anxiety and that it may have further utility in serving as a model for the development of new interventions. Additionally, our findings provide evidence that contemporary Web-based interventions can be sophisticated enough to benefit users even when delivered as stand-alone treatments, suggesting that further opportunities likely exist for the development of other Web-based mental health interventions. Trial Registration: ClinicalTrials.gov NCT02792127; https://clinicaltrials.gov/ct2/show/record/NCT02792127 (Archived by WebCite at http://www.webcitation.org/6xGSRh7MG) %M 29563078 %R 10.2196/jmir.8630 %U http://www.jmir.org/2018/3/e91/ %U https://doi.org/10.2196/jmir.8630 %U http://www.ncbi.nlm.nih.gov/pubmed/29563078 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 3 %P e97 %T Information Architecture of Web-Based Interventions to Improve Health Outcomes: Systematic Review %A Pugatch,Jillian %A Grenen,Emily %A Surla,Stacy %A Schwarz,Mary %A Cole-Lewis,Heather %+ ICF, 530 Gaither Road, Suite 500, Rockville, MD, 28770, United States, 1 301 572 0856, jillian.pugatch@icf.com %K information architecture %K systematic review %K health outcomes %K behavior change %K health behavior %D 2018 %7 21.03.2018 %9 Review %J J Med Internet Res %G English %X Background: The rise in usage of and access to new technologies in recent years has led to a growth in digital health behavior change interventions. As the shift to digital platforms continues to grow, it is increasingly important to consider how the field of information architecture (IA) can inform the development of digital health interventions. IA is the way in which digital content is organized and displayed, which strongly impacts users’ ability to find and use content. While many information architecture best practices exist, there is a lack of empirical evidence on the role it plays in influencing behavior change and health outcomes. Objective: Our aim was to conduct a systematic review synthesizing the existing literature on website information architecture and its effect on health outcomes, behavioral outcomes, and website engagement. Methods: To identify all existing information architecture and health behavior literature, we searched articles published in English in the following databases (no date restrictions imposed): ACM Digital Library, CINAHL, Cochrane Library, Google Scholar, Ebsco, and PubMed. The search terms used included information terms (eg, information architecture, interaction design, persuasive design), behavior terms (eg, health behavior, behavioral intervention, ehealth), and health terms (eg, smoking, physical activity, diabetes). The search results were reviewed to determine if they met the inclusion and exclusion criteria created to identify empirical research that studied the effect of IA on health outcomes, behavioral outcomes, or website engagement. Articles that met inclusion criteria were assessed for study quality. Then, data from the articles were extracted using a priori categories established by 3 reviewers. However, the limited health outcome data gathered from the studies precluded a meta-analysis. Results: The initial literature search yielded 685 results, which was narrowed down to three publications that examined the effect of information architecture on health outcomes, behavioral outcomes, or website engagement. One publication studied the isolated impact of information architecture on outcomes of interest (ie, website use and engagement; health-related knowledge, attitudes, and beliefs; and health behaviors), while the other two publications studied the impact of information architecture, website features (eg, interactivity, email prompts, and forums), and tailored content on these outcomes. The paper that investigated IA exclusively found that a tunnel IA improved site engagement and behavior knowledge, but it decreased users’ perceived efficiency. The first study that did not isolate IA found that the enhanced site condition improved site usage but not the amount of content viewed. The second study that did not isolate IA found that a tailored site condition improved site usage, behavior knowledge, and some behavior outcomes. Conclusions: No clear conclusion can be made about the relationship between IA and health outcomes, given limited evidence in the peer-reviewed literature connecting IA to behavioral outcomes and website engagement. Only one study reviewed solely manipulated IA, and we therefore recommend improving the scientific evidence base such that additional empirical studies investigate the impact of IA in isolation. Moreover, information from the gray literature and expert opinion might be identified and added to the evidence base, in order to lay the groundwork for hypothesis generation to improve empirical evidence on information architecture and health and behavior outcomes. %M 29563076 %R 10.2196/jmir.7867 %U http://www.jmir.org/2018/3/e97/ %U https://doi.org/10.2196/jmir.7867 %U http://www.ncbi.nlm.nih.gov/pubmed/29563076 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 3 %P e71 %T Comparing the Efficacy of a Mobile Phone-Based Blood Glucose Management System With Standard Clinic Care in Women With Gestational Diabetes: Randomized Controlled Trial %A Mackillop,Lucy %A Hirst,Jane Elizabeth %A Bartlett,Katy Jane %A Birks,Jacqueline Susan %A Clifton,Lei %A Farmer,Andrew J %A Gibson,Oliver %A Kenworthy,Yvonne %A Levy,Jonathan Cummings %A Loerup,Lise %A Rivero-Arias,Oliver %A Ming,Wai-Kit %A Velardo,Carmelo %A Tarassenko,Lionel %+ Oxford University Hospitals NHS Foundation Trust, Level 6, Women's Centre, John Radcliffe Hospital, Headley Way, Headington, OX3 9DU, United Kingdom, 44 7825517546, lucy.mackillop@ouh.nhs.uk %K gestational diabetes %K pregnancy %K digital health %K blood glucose monitoring %K app %K GDM %D 2018 %7 20.03.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Treatment of hyperglycemia in women with gestational diabetes mellitus (GDM) is associated with improved maternal and neonatal outcomes and requires intensive clinical input. This is currently achieved by hospital clinic attendance every 2 to 4 weeks with limited opportunity for intervention between these visits. Objective: We conducted a randomized controlled trial to determine whether the use of a mobile phone-based real-time blood glucose management system to manage women with GDM remotely was as effective in controlling blood glucose as standard care through clinic attendance. Methods: Women with an abnormal oral glucose tolerance test before 34 completed weeks of gestation were individually randomized to a mobile phone-based blood glucose management solution (GDm-health, the intervention) or routine clinic care. The primary outcome was change in mean blood glucose in each group from recruitment to delivery, calculated with adjustments made for number of blood glucose measurements, proportion of preprandial and postprandial readings, baseline characteristics, and length of time in the study. Results: A total of 203 women were randomized. Blood glucose data were available for 98 intervention and 85 control women. There was no significant difference in rate of change of blood glucose (–0.16 mmol/L in the intervention and –0.14 mmol/L in the control group per 28 days, P=.78). Women using the intervention had higher satisfaction with care (P=.049). Preterm birth was less common in the intervention group (5/101, 5.0% vs 13/102, 12.7%; OR 0.36, 95% CI 0.12-1.01). There were fewer cesarean deliveries compared with vaginal deliveries in the intervention group (27/101, 26.7% vs 47/102, 46.1%, P=.005). Other glycemic, maternal, and neonatal outcomes were similar in both groups. The median time from recruitment to delivery was similar (intervention: 54 days; control: 49 days; P=.23). However, there were significantly more blood glucose readings in the intervention group (mean 3.80 [SD 1.80] and mean 2.63 [SD 1.71] readings per day in the intervention and control groups, respectively; P<.001). There was no significant difference in direct health care costs between the two groups, with a mean cost difference of the intervention group compared to control of –£1044 (95% CI –£2186 to £99). There were no unexpected adverse outcomes. Conclusions: Remote blood glucocse monitoring in women with GDM is safe. We demonstrated superior data capture using GDm-health. Although glycemic control and maternal and neonatal outcomes were similar, women preferred this model of care. Further studies are required to explore whether digital health solutions can promote desired self-management lifestyle behaviors and dietetic adherence, and influence maternal and neonatal outcomes. Digital blood glucose monitoring may provide a scalable, practical method to address the growing burden of GDM around the world. Trial Registration: ClinicalTrials.gov NCT01916694; https://clinicaltrials.gov/ct2/show/NCT01916694 (Archived by WebCite at http://www.webcitation.org/6y3lh2BOQ) %M 29559428 %R 10.2196/mhealth.9512 %U http://mhealth.jmir.org/2018/3/e71/ %U https://doi.org/10.2196/mhealth.9512 %U http://www.ncbi.nlm.nih.gov/pubmed/29559428 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 3 %P e81 %T A Mobile App to Improve Self-Management of Individuals With Type 2 Diabetes: Qualitative Realist Evaluation %A Desveaux,Laura %A Shaw,James %A Saragosa,Marianne %A Soobiah,Charlene %A Marani,Husayn %A Hensel,Jennifer %A Agarwal,Payal %A Onabajo,Nike %A Bhatia,R Sacha %A Jeffs,Lianne %+ Institute for Health System Solutions and Virtual Care, Women's College Hospital, 76 Grenville St, Toronto, ON, M5S 1B2, Canada, 1 416 323 6400 ext 8356, laura.desveaux@wchospital.ca %K telemedicine %K diabetes mellitus %K self-management %K qualitative research %D 2018 %7 16.03.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: The increasing use of Web-based solutions for health prevention and promotion presents opportunities to improve self-management and adherence to guideline-based therapy for individuals with type 2 diabetes (T2DM). Despite promising preliminary evidence, many users stop using Web-based solutions due to the burden of data entry, hidden costs, loss of interest, and a lack of comprehensive features. Evaluations tend to focus on effectiveness or impact and fail to evaluate the nuanced variables that may interact to contribute to outcome success (or failure). Objective: This study aimed to evaluate a Web-based solution for improving self-management in T2DM to identify key combinations of contextual variables and mechanisms of action that explain for whom the solution worked best and in what circumstances. Methods: A qualitative realist evaluation was conducted with one-on-one, semistructured telephonic interviews completed at baseline, and again toward the end of the intervention period (3 months). Topics included participants’ experiences of using the Web-based solution, barriers and facilitators of self-management, and barriers and facilitators to effective use. Transcripts were analyzed using thematic analysis strategies, after which the key themes were used to develop statements of the relationships between the key contextual factors, mechanisms of action, and impact on the primary outcome (glycated hemoglobin, HbA1c). Results: Twenty-six interviews (14 baseline, 12 follow-up) were completed with 16 participants with T2DM, and the following 3 key groups emerged: the easiest fit, the best fit, and those who failed to activate. Self-efficacy and willingness to engage with the solution facilitated improvement in HbA1c, whereas competing priorities and psychosocial issues created barriers to engagement. Individuals with high baseline self-efficacy who were motivated, took ownership for their actions, and prioritized diabetes management were early and eager adopters of the app and recorded improvements in HbA1c over the intervention period. Individuals with moderate baseline self-efficacy and no competing priorities, who identified gaps in understanding of how their actions influence their health, were slow to adopt use but recorded the greatest improvements in HbA1c. The final group had low baseline self-efficacy and identified a range of psychosocial issues and competing priorities. These participants were uncertain of the benefits of using a Web-based solution to support self-management, ultimately resulting in minimal engagement and no improvement in HbA1c. Conclusions: Self-efficacy, competing priorities, previous behavior change, and beliefs about Web-based solutions interact to determine engagement and impact on the clinical outcomes. Considering the balance of these patient characteristics is likely to help health care providers identify individuals who are apt to benefit from a Web-based solution to support self-management of T2DM. Web-based solutions could be modified to incorporate the existing screening measures to identify individuals who are at risk of suboptimal adherence to inform the provision of additional support(s) as needed. %M 29549070 %R 10.2196/jmir.8712 %U http://www.jmir.org/2018/3/e81/ %U https://doi.org/10.2196/jmir.8712 %U http://www.ncbi.nlm.nih.gov/pubmed/29549070 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 3 %P e87 %T Treatment Activity, User Satisfaction, and Experienced Usability of Internet-Based Cognitive Behavioral Therapy for Adults With Depression and Anxiety After a Myocardial Infarction: Mixed-Methods Study %A Wallin,Emma %A Norlund,Fredrika %A Olsson,Erik Martin Gustaf %A Burell,Gunilla %A Held,Claes %A Carlsson,Tommy %+ Department of Psychology, Uppsala University, Box 1225, Uppsala, 75142, Sweden, 46 0706606118, emma.wallin@psyk.uu.se %K mental health %K internet %K cognitive behavioral therapy %K computer-assisted therapy %K myocardial infarction %K attrition %K adherence %D 2018 %7 16.03.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Knowledge about user experiences may lead to insights about how to improve treatment activity in Internet-based cognitive behavioral therapy (iCBT) to reduce symptoms of depression and anxiety among people with a somatic disease. There is a need for studies conducted alongside randomized trials, to explore treatment activity and user experiences related to such interventions, especially among people with older age who are recruited in routine care. Objective: The aim of the study was to explore treatment activity, user satisfaction, and usability experiences among patients allocated to treatment in the U-CARE Heart study, a randomized clinical trial of an iCBT intervention for treatment of depression and anxiety following a recent myocardial infarction. Methods: This was a mixed methods study where quantitative and qualitative approaches were used. Patients were recruited consecutively from 25 cardiac clinics in Sweden. The study included 117 patients allocated to 14 weeks of an iCBT intervention in the U-CARE Heart study. Quantitative data about treatment activity and therapist communication were collected through logged user patterns, which were analyzed with descriptive statistics. Qualitative data with regard to positive and negative experiences, and suggestions for improvements concerning the intervention, were collected through semistructured interviews with 21 patients in the treatment arm after follow-up. The interviews were analyzed with qualitative manifest content analysis. Results: Treatment activity was low with regard to number of completed modules (mean 0.76, SD 0.93, range 0-5) and completed assignments (mean 3.09, SD 4.05, range 0-29). Most of the participants initiated the introduction module (113/117, 96.6%), and about half (63/117, 53.9%) of all participants completed the introductory module, but only 18 (15.4%, 18/117) continued to work with any of the remaining 10 modules, and each of the remaining modules was completed by 7 or less of the participants. On average, patients sent less than 2 internal messages to their therapist during the intervention (mean 1.42, SD 2.56, range 0-16). Interviews revealed different preferences with regard to the internet-based portal, the content of the treatment program, and the therapist communication. Aspects related to the personal situation and required skills included unpleasant emotions evoked by the intervention, lack of time, and technical difficulties. Conclusions: Patients with a recent myocardial infarction and symptoms of depression and anxiety showed low treatment activity in this guided iCBT intervention with regard to completed modules, completed assignments, and internal messages sent to their therapist. The findings call attention to the need for researchers to carefully consider the preferences, personal situation, and technical skills of the end users during the development of these interventions. The study indicates several challenges that need to be addressed to improve treatment activity, user satisfaction, and usability in internet-based interventions in this population. %M 29549067 %R 10.2196/jmir.9690 %U http://www.jmir.org/2018/3/e87/ %U https://doi.org/10.2196/jmir.9690 %U http://www.ncbi.nlm.nih.gov/pubmed/29549067 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 3 %P e92 %T Expert Coaching in Weight Loss: Retrospective Analysis %A Painter,Stefanie Lynn %A Ahmed,Rezwan %A Kushner,Robert F %A Hill,James O %A Lindquist,Richard %A Brunning,Scott %A Margulies,Amy %+ Retrofit, Inc, 123 N. Wacker Drive, Suite 1250, Chicago, IL, 60606, United States, 1 18007745962, stefanie@retrofitme.com %K body mass index %K coaching %K feedback %K obesity %K overweight %K weight loss %K weight reduction program %D 2018 %7 13.03.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Providing coaches as part of a weight management program is a common practice to increase participant engagement and weight loss success. Understanding coach and participant interactions and how these interactions impact weight loss success needs to be further explored for coaching best practices. Objective: The purpose of this study was to analyze the coach and participant interaction in a 6-month weight loss intervention administered by Retrofit, a personalized weight management and Web-based disease prevention solution. The study specifically examined the association between different methods of coach-participant interaction and weight loss and tried to understand the level of coaching impact on weight loss outcome. Methods: A retrospective analysis was performed using 1432 participants enrolled from 2011 to 2016 in the Retrofit weight loss program. Participants were males and females aged 18 years or older with a baseline body mass index of ≥25 kg/m², who also provided at least one weight measurement beyond baseline. First, a detailed analysis of different coach-participant interaction was performed using both intent-to-treat and completer populations. Next, a multiple regression analysis was performed using all measures associated with coach-participant interactions involving expert coaching sessions, live weekly expert-led Web-based classes, and electronic messaging and feedback. Finally, 3 significant predictors (P<.001) were analyzed in depth to reveal the impact on weight loss outcome. Results: Participants in the Retrofit weight loss program lost a mean 5.14% (SE 0.14) of their baseline weight, with 44% (SE 0.01) of participants losing at least 5% of their baseline weight. Multiple regression model (R2=.158, P<.001) identified the following top 3 measures as significant predictors of weight loss at 6 months: expert coaching session attendance (P<.001), live weekly Web-based class attendance (P<.001), and food log feedback days per week (P<.001). Attending 80% of expert coaching sessions, attending 60% of live weekly Web-based classes, and receiving a minimum of 1 food log feedback day per week were associated with clinically significant weight loss. Conclusions: Participant’s one-on-one expert coaching session attendance, live weekly expert-led interactive Web-based class attendance, and the number of food log feedback days per week from expert coach were significant predictors of weight loss in a 6-month intervention. %M 29535082 %R 10.2196/jmir.9738 %U http://www.jmir.org/2018/3/e92/ %U https://doi.org/10.2196/jmir.9738 %U http://www.ncbi.nlm.nih.gov/pubmed/29535082 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 3 %P e88 %T Internet-Based Cognitive Behavioral Therapy for Symptoms of Depression and Anxiety Among Patients With a Recent Myocardial Infarction: The U-CARE Heart Randomized Controlled Trial %A Norlund,Fredrika %A Wallin,Emma %A Olsson,Erik Martin Gustaf %A Wallert,John %A Burell,Gunilla %A von Essen,Louise %A Held,Claes %+ Clinical Psychology in Healthcare, Department of Women's and Children's Health, Uppsala University, Akademiska sjukhuset, Uppsala, 75185, Sweden, 46 737441304, fredrika.norlund@kbh.uu.se %K eHealth %K treatment adherence and compliance %K patient acceptance of health care %K patient selection %K cardiac rehabilitation %D 2018 %7 08.03.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Symptoms of depression and anxiety are common after a myocardial infarction (MI). Internet-based cognitive behavioral therapy (iCBT) has shown good results in other patient groups. Objective: The aim of this study was to evaluate the effectiveness of an iCBT treatment to reduce self-reported symptoms of depression and anxiety among patients with a recent MI. Methods: In total, 3928 patients were screened for eligibility in 25 Swedish hospitals. Of these, 239 patients (33.5%, 80/239 women, mean age 60 years) with a recent MI and symptoms of depression or anxiety were randomly allocated to a therapist-guided, 14-week iCBT treatment (n=117), or treatment as usual (TAU; n=122). The iCBT treatment was designed for post-MI patients. The primary outcome was the total score of the Hospital Anxiety and Depression Scale (HADS) 14 weeks post baseline, assessed over the internet. Treatment effect was evaluated according to the intention-to-treat principle, with multiple imputations. For the main analysis, a pooled treatment effect was estimated, controlling for age, sex, and baseline HADS. Results: There was a reduction in HADS scores over time in the total study sample (mean delta=−5.1, P<.001) but no difference between the study groups at follow-up (beta=−0.47, 95% CI −1.95 to 1.00, P=.53). Treatment adherence was low. A total of 46.2% (54/117) of the iCBT group did not complete the introductory module. Conclusions: iCBT treatment for an MI population did not result in lower levels of symptoms of depression or anxiety compared with TAU. Low treatment adherence might have influenced the result. Trial Registration: ClinicalTrials.gov NCT01504191; https://clinicaltrials.gov/ct2/show/NCT01504191 (Archived at Webcite at http://www.webcitation.org/6xWWSEQ22) %M 29519777 %R 10.2196/jmir.9710 %U http://www.jmir.org/2018/3/e88/ %U https://doi.org/10.2196/jmir.9710 %U http://www.ncbi.nlm.nih.gov/pubmed/29519777 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 3 %P e74 %T Web-Based Activity Within a Sexual Health Economy: Observational Study %A Turner,Katy ME %A Zienkiewicz,Adam K %A Syred,Jonathan %A Looker,Katharine J %A de Sa,Joia %A Brady,Michael %A Free,Caroline %A Holdsworth,Gillian %A Baraitser,Paula %+ Bristol Veterinary School, University of Bristol, Churchill Building, Langford Campus, Bristol, BS40 5DU, United Kingdom, 44 1173319120, Katy.Turner@bristol.ac.uk %K sexually transmitted diseases %K testing %K internet %K self-sampling %D 2018 %7 07.03.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Regular testing for sexually transmitted infections (STIs) is important to maintain sexual health. Self-sampling kits ordered online and delivered in the post may increase access, convenience, and cost-effectiveness. Sexual health economies may target limited resources more effectively by signposting users toward Web-based or face-to-face services according to clinical need. Objective: The aim of this paper was to investigate the impact of two interventions on testing activity across a whole sexual health economy: (1) the introduction of open access Web-based STI testing services and (2) a clinic policy of triage and signpost online where users without symptoms who attended clinics for STI testing were supported to access the Web-based service instead. Methods: Data on attendances at all specialist public sexual health providers in an inner-London area were collated into a single database. Each record included information on user demographics, service type accessed, and clinical activity provided, including test results. Clinical activity was categorized as a simple STI test (could be done in a clinic or online), a complex visit (requiring face-to-face consultation), or other. Results: Introduction of Web-based services increased total testing activity across the whole sexual health economy by 18.47% (from 36,373 to 43,091 in the same 6-month period—2014-2015 and 2015-2016), suggesting unmet need for testing in the area. Triage and signposting shifted activity out of the clinic onto the Web-based service, with simple STI testing in the clinic decreasing from 16.90% (920/5443) to 12.25% (511/4172) of total activity, P<.001, and complex activity in the clinic increasing from 69.15% (3764/5443) to 74.86% (3123/4172) of total activity, P<.001. This intervention created a new population of online users with different demographic and clinical profiles from those who use Web-based services spontaneously. Some triage and signposted users (29.62%, 375/1266) did not complete the Web-based testing process, suggesting the potential for missed diagnoses. Conclusions: This evaluation shows that users can effectively be transitioned from face-to-face to Web-based services and that this introduces a new population to Web-based service use and changes the focus of clinic-based activity. Further development is underway to optimize the triage and signposting process to support test completion. %M 29514776 %R 10.2196/jmir.8101 %U https://www.jmir.org/2018/3/e74/ %U https://doi.org/10.2196/jmir.8101 %U http://www.ncbi.nlm.nih.gov/pubmed/29514776 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 1 %P e18 %T Targeted Secure Messages to Facilitate Access to Tobacco Treatment Counseling for Veterans: Feasibility Study %A Shahani,Shaun %A Korenblit,Pearl %A Thomas,Pauline %A Passannante,Marian R %A Carr,Richard %A Davis,Lynn %+ Rutgers New Jersey Medical School, 185 S Orange Ave, Newark, NJ, 07103, United States, 1 732 445 4636, shaun.shahani@tu.edu %K secure messaging %K tobacco use %K smoking cessation %D 2018 %7 05.03.2018 %9 Original Paper %J JMIR Ment Health %G English %X Background: Studies show that combining nicotine replacement therapy (NRT) with tobacco treatment counseling is most effective for smoking cessation. However, tobacco treatment counseling has been underutilized across the nation. A secure email message sent to patients already taking NRT was hypothesized to increase the utilization of tobacco treatment counseling among Veterans in New Jersey. Secure messaging for communication between patients and providers was implemented through a web-based password-protected, secure messaging account, where Veterans get notified through their personal email when they have a message awaiting them. Objective: The main objective of this project was to determine if there was a significant increase in adoption of tobacco treatment counseling among Veterans who received a secure message describing the options for tobacco treatment counseling available to them. Secondary objectives were to demographically characterize Veterans who were and were not enrolled in secure messaging, as well as those who opened or did not open a message. Finally, because the language and content of the messages were changed across project phases, this project also sought to determine (by analysis of response rates) the type of language that was most effective at eliciting a response. Methods: Over two phases, messages were sent to two samples of Veterans prescribed NRT within the prior 90 days of each phase. In phase 1, one message was sent in December 2015 (message 1). In phase 2, one message was sent in July 2016 (message 2) and the same message (message 3) was resent in August 2016 to persons who did not open message 2. Messages 2 and 3 were more directive than message 1. Response rates to message 1 versus message 2 were compared. A logistic regression analysis determined effect of age and gender on enrollment in secure messaging across both phases. The effectiveness of each phase at increasing tobacco treatment counseling was analyzed using a McNemar test. Results: Message 2, sent to 423 Veterans, had a significantly higher response rate than message 1, sent to 348 Veterans (18%, 17/93 vs 8%, 6/78, P=.04). Phase 2 (ie, messages 2 and 3) significantly increased utilization of tobacco treatment counseling (net increase of six tobacco treatment counseling adopters, P=.04), whereas phase 1 (ie, message 1) did not (net increase of two tobacco treatment counseling adopters, P=.48). Women (odds ratio [OR] 1.6, 95% CI 1.1-2.3) and those aged 30 to 49 years (compared to other age groups) were more likely to be enrolled in secure messaging. Gender and age were not significant predictors of opening or replying to either message. Conclusions: Although the effect was small, secure messaging was a useful modality to increase tobacco treatment counseling. Directive content with a follow-up message appeared useful. Female Veterans and/or Veterans aged between 30 and 49 years are more likely to use secure messaging. %M 29506969 %R 10.2196/mental.7957 %U http://mental.jmir.org/2018/1/e18/ %U https://doi.org/10.2196/mental.7957 %U http://www.ncbi.nlm.nih.gov/pubmed/29506969 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 3 %P e63 %T Optimizing Tailored Communications for Health Risk Assessment: A Randomized Factorial Experiment of the Effects of Expectancy Priming, Autonomy Support, and Exemplification %A Valle,Carmina G %A Queen,Tara L %A Martin,Barbara A %A Ribisl,Kurt M %A Mayer,Deborah K %A Tate,Deborah F %+ Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 135 Dauer Drive, MHRC 2004, Campus Box #7461, Chapel Hill, NC, 27599 7461, United States, 1 919 843 6886, carmina.valle@unc.edu %K health communication %K feedback %K eHealth %K health risk assessment %K health behavior %K intention %K self-efficacy %K personal autonomy %D 2018 %7 01.03.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Health risk assessments with tailored feedback plus health education have been shown to be effective for promoting health behavior change. However, there is limited evidence to guide the development and delivery of online automated tailored feedback. Objective: The goal of this study was to optimize tailored feedback messages for an online health risk assessment to promote enhanced user engagement, self-efficacy, and behavioral intentions for engaging in healthy behaviors. We examined the effects of three theory-based message factors used in developing tailored feedback messages on levels of engagement, self-efficacy, and behavioral intentions. Methods: We conducted a randomized factorial experiment to test three different components of tailored feedback messages: tailored expectancy priming, autonomy support, and use of an exemplar. Individuals (N=1945) were recruited via Amazon Mechanical Turk and randomly assigned to one of eight different experimental conditions within one of four behavioral assessment and feedback modules (tobacco use, physical activity [PA], eating habits, and weight). Participants reported self-efficacy and behavioral intentions pre- and postcompletion of an online health behavior assessment with tailored feedback. Engagement and message perceptions were assessed at follow-up. Results: For the tobacco module, there was a significant main effect of the exemplar factor (P=.04); participants who received exemplar messages (mean 3.31, SE 0.060) rated their self-efficacy to quit tobacco higher than those who did not receive exemplar messages (mean 3.14, SE 0.057). There was a three-way interaction between the effect of message conditions on self-efficacy to quit tobacco (P=.02), such that messages with tailored priming and an exemplar had the greatest impact on self-efficacy to quit tobacco. Across PA, eating habits, and weight modules, there was a three-way interaction among conditions on self-efficacy (P=.048). The highest self-efficacy scores were reported among those who were in the standard priming condition and received both autonomy supportive and exemplar messages. In the PA module, autonomy supportive messages had a stronger effect on self-efficacy for PA in the standard priming condition. For PA, eating habits, and weight-related behaviors, the main effect of exemplar messages on behavioral intentions was in the hypothesized direction but did not reach statistical significance (P=.08). When comparing the main effects of different message conditions, there were no differences in engagement and message perceptions. Conclusions: Findings suggest that tailored feedback messages that use exemplars helped improve self-efficacy related to tobacco cessation, PA, eating habits, and weight control. Combining standard priming and autonomy supportive message components shows potential for optimizing tailored feedback for tobacco cessation and PA behaviors. %M 29496652 %R 10.2196/jmir.7613 %U https://www.jmir.org/2018/3/e63/ %U https://doi.org/10.2196/jmir.7613 %U http://www.ncbi.nlm.nih.gov/pubmed/29496652 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 2 %P e72 %T A Novel Approach for Fully Automated, Personalized Health Coaching for Adults with Prediabetes: Pilot Clinical Trial %A Everett,Estelle %A Kane,Brian %A Yoo,Ashley %A Dobs,Adrian %A Mathioudakis,Nestoras %+ Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Johns Hopkins University, 1830 E. Monument Street, Suite 333, Baltimore, MD, 21287, United States, 1 410 502 8089, nmathio1@jhmi.edu %K mobile health %K prediabetes %K HbA 1c %K weight loss %K blood glucose %D 2018 %7 27.02.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Prediabetes is a high-risk state for the future development of type 2 diabetes, which may be prevented through physical activity (PA), adherence to a healthy diet, and weight loss. Mobile health (mHealth) technology is a practical and cost-effective method of delivering diabetes prevention programs in a real-world setting. Sweetch (Sweetch Health, Ltd) is a fully automated, personalized mHealth platform designed to promote adherence to PA and weight reduction in people with prediabetes.  Objective: The objective of this pilot study was to calibrate the Sweetch app and determine the feasibility, acceptability, safety, and effectiveness of the Sweetch app in combination with a digital body weight scale (DBWS) in adults with prediabetes. Methods: This was a 3-month prospective, single-arm, observational study of adults with a diagnosis of prediabetes and body mass index (BMI) between 24 kg/m2 and 40 kg/m2. Feasibility was assessed by study retention. Acceptability of the mobile platform and DBWS were evaluated using validated questionnaires. Effectiveness measures included change in PA, weight, BMI, glycated hemoglobin (HbA1c), and fasting blood glucose from baseline to 3-month visit. The significance of changes in outcome measures was evaluated using paired t test or Wilcoxon matched pairs test. Results: The study retention rate was 47 out of 55 (86%) participants. There was a high degree of acceptability of the Sweetch app, with a median (interquartile range [IQR]) score of 78% (73%-80%) out of 100% on the validated System Usability Scale. Satisfaction regarding the DBWS was also high, with median (IQR) score of 93% (83%-100%). PA increased by 2.8 metabolic equivalent of task (MET)–hours per week (SD 6.8; P=.02), with mean weight loss of 1.6 kg (SD 2.5; P<.001) from baseline. The median change in A1c was −0.1% (IQR −0.2% to 0.1%; P=.04), with no significant change in fasting blood glucose (−1 mg/dL; P=.59). There were no adverse events reported. Conclusions: The Sweetch mobile intervention program is a safe and effective method of increasing PA and reducing weight and HbA1c in adults with prediabetes. If sustained over a longer period, this intervention would be expected to reduce diabetes risk in this population. Trial Registration: ClincialTrials.gov NCT02896010; https://clinicaltrials.gov/ct2/show/NCT02896010 (Archived by WebCite at http://www.webcitation.org/6xJYxrgse) %M 29487046 %R 10.2196/jmir.9723 %U http://www.jmir.org/2018/2/e72/ %U https://doi.org/10.2196/jmir.9723 %U http://www.ncbi.nlm.nih.gov/pubmed/29487046 %0 Journal Article %@ 2562-0959 %I JMIR Publications %V 1 %N 1 %P e1 %T Acceptability and Feasibility of a Trial Testing Allocation to Sunscreen and a Smartphone App for Sun Protection: Discontinued Randomized Controlled Trial %A Rodrigues,Angela M %A Sniehotta,Falko F %A Birch-Machin,Mark A %A Olivier,Patrick %A Araújo-Soares,Vera %+ Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle, NE2 4AX, United Kingdom, 44 191 208 8974, angela.rodrigues@newcastle.ac.uk %K sunscreening agents %K sun protection factor %K smartphone %K mobile applications %K feasibility studies %K randomized controlled trial %K skin neoplasms %K melanoma %K skin aging %K holidays %K health promotion %K health behavior %D 2018 %7 27.02.2018 %9 Original Paper %J JMIR Dermatol %G English %X Background: Recreational sun exposure has been associated with melanoma prevalence, and tourism settings are of particular interest for skin cancer prevention. Effective, affordable, and geographically flexible interventions to promote sun protection are needed. Objective: The aim of this study was to describe the protocol for a definitive randomized controlled trial (RCT) evaluating a smartphone mobile intervention (mISkin app) promoting sun protection in holidaymakers and to assess the acceptability and feasibility of the mISkin app and associated trial procedures in an internal pilot study. Methods: Participants were recruited from the general community. Holidaymakers traveling abroad and owning a smartphone were enrolled in the internal pilot of a 2 (mISkin vs control) x 2 (sun protection factor [SPF] 15 vs SPF 30) RCT with a postholiday follow-up. The smartphone app is fully automated and entails a behavioral intervention to promote sun protection. It consisted of five components: skin assessment, educational videos, ultraviolet (UV) photos, gamification, and prompts for sun protection. Participants were also randomly allocated to receive sunscreen SPF 15 or SPF 30. Primary outcomes for the internal pilot study were acceptability and feasibility of trial procedures and intervention features. Secondary outcomes were collected at baseline and after holidays through face-to-face-assessments and included skin sun damage, sunscreen use (residual weight and application events), and sun protection practices (Web-based questionnaire). Results: From 142 registers of interest, 42 participants were randomized (76% [32/42] female; mean age 35.5 years). Outcome assessments were completed by all participants. Random allocation to SPF 15 versus SPF 30 was found not to be feasible in a definitive trial protocol. Of the 21 people allocated to the mISkin intervention, 19 (91%) installed the mISkin on their phones, and 18 (86%) used it at least once. Participants were satisfied with the mISkin app and made suggestions for further improvements. Due to difficulties with the random allocation to SPF and slow uptake, the trial was discontinued. Conclusions: The internal pilot study concluded that randomization to SPF was not feasible and that recruitment rate was slower than expected because of difficulties with gatekeeper engagement. Possible solutions to the problems identified are discussed. Further refinements to the mISkin app are needed before a definitive trial. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN63943558; http://www.isrctn.com/ISRCTN63943558 (Archived by WebCite at http://www.webcitation.org/6xOLvbab8) %R 10.2196/derma.8608 %U https://derma.jmir.org/2018/1/e1/ %U https://doi.org/10.2196/derma.8608 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 2 %P e67 %T A Web-Based, Social Networking Beginners’ Running Intervention for Adults Aged 18 to 50 Years Delivered via a Facebook Group: Randomized Controlled Trial %A Looyestyn,Jemma %A Kernot,Jocelyn %A Boshoff,Kobie %A Maher,Carol %+ Alliance for Research in Exercise, Nutrition, and Physical Activity, University of South Australia, GPO Box 2471, Adelaide, 5001, Australia, 61 883022575, jocelyn.kernot@unisa.edu.au %K social network %K health behavior %K program evaluation %K Internet %K physical activity %D 2018 %7 26.02.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Online social networks continue to grow in popularity, with 1.7 billion users worldwide accessing Facebook each month. The use of social networking sites such as Facebook for the delivery of health behavior programs is relatively new. Objective: The primary aim of this study was to determine the effectiveness of a Web-based beginners’ running program for adults aged 18 to 50 years, delivered via a Facebook group, in increasing physical activity (PA) and cardiorespiratory fitness. Methods: A total of 89 adults with a mean age of 35.2 years (SD 10.9) were recruited online and via print media. Participants were randomly allocated to receive the UniSA Run Free program, an 8-week Web-based beginners’ running intervention, delivered via a closed Facebook group (n=41) that included daily interactive posts (information with links, motivational quotes, opinion polls, or questions) and details of the running sessions; or to the control group who received a hard copy of the running program (n=48). Assessments were completed online at baseline, 2 months, and 5 months. The primary outcome measures were self-reported weekly moderate to vigorous physical activity (MVPA) and objectively measured cardiorespiratory fitness. Secondary outcomes were social support, exercise attitudes, and self-efficacy. Analyses were undertaken using random effects mixed modeling. Compliance with the running program and engagement with the Facebook group were analyzed descriptively. Results: Both groups significantly increased MVPA across the study period (P=.004); however, this was significantly higher in the Facebook group (P=.04). The Facebook group increased their MVPA from baseline by 140 min/week versus 91 min for the control at 2 months. MVPA remained elevated for the Facebook group (from baseline) by 129 min/week versus a 50 min/week decrease for the control at 5 months. Both groups had significant increases in social support scores at 2 months (P=.02); however, there were no group by time differences (P=.16). There were no significant changes in the other outcomes. A process evaluation revealed relatively high levels of engagement with the Facebook group during the 8-week intervention (eg, mean number of interactions 35 [SD 41]). Conclusions: An 8-week beginners’ running program delivered through Facebook produced sizable and sustained changes in weekly MVPA and received strong engagement and positive feedback from participants. Future research investigating this intervention approach is warranted in other populations and health behaviors. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12616001500448; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371607&isReview=true (Archived by WebCite at http://www.webcitation.org/6xSAuz4NW) %M 29483065 %R 10.2196/jmir.7862 %U http://www.jmir.org/2018/2/e67/ %U https://doi.org/10.2196/jmir.7862 %U http://www.ncbi.nlm.nih.gov/pubmed/29483065 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 2 %P e40 %T Digital Health Interventions for Adults With Type 2 Diabetes: Qualitative Study of Patient Perspectives on Diabetes Self-Management Education and Support %A Pal,Kingshuk %A Dack,Charlotte %A Ross,Jamie %A Michie,Susan %A May,Carl %A Stevenson,Fiona %A Farmer,Andrew %A Yardley,Lucy %A Barnard,Maria %A Murray,Elizabeth %+ Department of Primary Care and Population Health, University College London, Upper 3rd floor, Royal Free Hospital, Rowland Hill St, London, NW32PF, United Kingdom, 44 020 7794 0500 ext 38826, k.pal@ucl.ac.uk %K diabetes mellitus, type 2 %K self-management %K patient education %K eHealth %K mHealth %K qualitative research %D 2018 %7 20.02.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: The prevalence of type 2 diabetes is increasing globally, and health services in many countries are struggling with the morbidity, mortality, and costs associated with the complications of this long-term condition. Diabetes self-management education (DSME) and behavioral support can reduce the risks of developing diabetes-related complications and improve glycemic control. However, their uptake is low. Digital health interventions (DHI) can provide sustained support and may overcome challenges associated with attending diabetes self-management sessions. They have the potential for delivery at multiple locations at convenient times, anonymity, and presentation of content in attractive and tailored formats. This study investigates the needs and wants of patients with type 2 diabetes to inform the development of digital self-management education and support. Objective: The objective of this study was to explore patient perspectives on unmet needs for self-management and support and the role of DHI in adults living with type 2 diabetes. Methods: This study used a qualitative approach based on data generated from 4 focus groups with 20 patients. Results: The data generated by the focus groups illustrated the significant burden that the diagnosis of diabetes places on many patients and the negative impacts on their emotional well-being, work, social life, and physical health. Although patients’ experiences of the health care services varied, there was agreement that even the best services were unable to meet all users’ needs to support the emotional regulation, psychological adjustment, and behavioral changes needed for successful self-management. Conclusions: By focusing on medical management and information provision, existing health care services and education programs may not be adequately meeting all the needs of patients with type 2 diabetes. DHIs have the potential to improve access to DSME and behavioral support and extend the range of content offered by health services to fit with a wider range of patient needs. Features that could help DHIs address some of the unmet needs described by participants in this study included placing an emphasis on emotional and role management, being available at all times, having up-to-date evidence-based guidance for patients, and providing access to peer-generated and professional advice. %M 29463488 %R 10.2196/jmir.8439 %U http://www.jmir.org/2018/2/e40/ %U https://doi.org/10.2196/jmir.8439 %U http://www.ncbi.nlm.nih.gov/pubmed/29463488 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 1 %P e14 %T Influencing the Conversation About Masculinity and Suicide: Evaluation of the Man Up Multimedia Campaign Using Twitter Data %A Schlichthorst,Marisa %A King,Kylie %A Turnure,Jackie %A Sukunesan,Suku %A Phelps,Andrea %A Pirkis,Jane %+ Centre for Mental Health, Melbourne School of Population and Global Health, The University of Melbourne, 207 Bouverie Street, Parkville, 3010, Australia, 61 390353508, marisa.schlichthorst@unimelb.edu.au %K mental health %K suicide %K masculinity %K men’s health %D 2018 %7 15.02.2018 %9 Original Paper %J JMIR Ment Health %G English %X Background: It has been suggested that some dominant aspects of traditional masculinity are contributing to the high suicide rates among Australian men. We developed a three-episode documentary called Man Up, which explores the complex relationship between masculinity and suicide and encourages men to question socially imposed rules about what it means to be a man and asks them to open up, express difficult emotions, and seek help if and when needed. We ran a three-phase social media campaign alongside the documentary using 5 channels (Twitter, Facebook, Instagram, YouTube, and Tumblr). Objective: This study aimed to examine the extent to which the Man Up Twitter campaign influenced the social media conversation about masculinity and suicide. Methods: We used Twitter insights data to assess the reach of and engagement with the campaign (using metrics on followers, likes, retweets, and impressions) and to determine the highest and lowest performing tweets in the campaign (using an aggregated performance measure of reactions). We used original content tweets to determine whether the campaign increased the volume of relevant Twitter conversations (aggregating the number of tweets for selected campaign hashtags over time), and we used a subset of these data to gain insight into the main content themes with respect to audience engagement. Results: The campaign generated a strong following that was engaged with the content of the campaign; over its whole duration, the campaign earned approximately 5000 likes and 2500 retweets and gained around 1,022,000 impressions. The highest performing tweets posted by the host included video footage and occurred during the most active period of the campaign (around the screening of the documentary). The volume of conversations in relation to commonly used hashtags (#MANUP, #ABCMANUP, #LISTENUP, and #SPEAKUP) grew in direct relation to the campaign activities, achieving strongest growth during the 3 weeks when the documentary was aired. Strongest engagement was found with content related to help-seeking, masculinity, and expressing emotions. A number of followers tweeted personal stories that revealed overwhelmingly positive perceptions of the content of the documentary and strongly endorsed its messages. Conclusions: The Man Up Twitter campaign triggered conversations about masculinity and suicide that otherwise may not have happened. For some, this may have been game-changing in terms of shifting attitudes toward expressing emotions and reaching out to others for help. The campaign was particularly effective in disseminating information and promoting conversations in real time, an advantage that it had over more traditional health promotion campaigns. This sort of approach could well be adapted to other areas of mental (and physical) health promotion campaigns to increase their reach and effectiveness. %M 29449203 %R 10.2196/mental.9120 %U http://mental.jmir.org/2018/1/e14/ %U https://doi.org/10.2196/mental.9120 %U http://www.ncbi.nlm.nih.gov/pubmed/29449203 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 2 %P e15 %T Effectiveness of a Web-Based Self-Help Program for Suicidal Thinking in an Australian Community Sample: Randomized Controlled Trial %A van Spijker,Bregje AJ %A Werner-Seidler,Aliza %A Batterham,Philip J %A Mackinnon,Andrew %A Calear,Alison L %A Gosling,John A %A Reynolds,Julia %A Kerkhof,Ad JFM %A Solomon,Daniela %A Shand,Fiona %A Christensen,Helen %+ Black Dog Institute, Department of Medicine, University of New South Wales, Hospital Road, Randwick,, Australia, 61 293 823 717, h.christensen@blackdog.org.au %K psychosocial interventions %K randomized controlled trial %K suicide %D 2018 %7 14.02.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Treatment for suicidality can be delivered online, but evidence for its effectiveness is needed. Objective: The goal of our study was to examine the effectiveness of an online self-help intervention for suicidal thinking compared to an attention-matched control program. Methods: A 2-arm randomized controlled trial was conducted with assessment at postintervention, 6, and, 12 months. Through media and community advertizing, 418 suicidal adults were recruited to an online portal and were delivered the intervention program (Living with Deadly Thoughts) or a control program (Living Well). The primary outcome was severity of suicidal thinking, assessed using the Columbia Suicide Severity Rating Scale. Results: Intention-to-treat analyses showed significant reductions in the severity of suicidal thinking at postintervention, 6, and 12 months. However, no overall group differences were found. Conclusions: Living with Deadly Thoughts was of no greater effectiveness than the control group. Further investigation into the conditions under which this program may be beneficial is now needed. Limitations of this trial include it being underpowered given the effect size ultimately observed, a high attrition rate, and the inability of determining suicide deaths or of verifying self-reported suicide attempts. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12613000410752; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=364016 (Archived by WebCite at http://www.webcitation.org/6vK5FvQXy); Universal Trial Number U1111-1141-6595 %M 29444769 %R 10.2196/jmir.8595 %U https://www.jmir.org/2018/2/e15/ %U https://doi.org/10.2196/jmir.8595 %U http://www.ncbi.nlm.nih.gov/pubmed/29444769 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 2 %P e18 %T Mobile Phone Apps for Behavioral Interventions for At-Risk Drinkers in Australia: Literature Review %A Choo,Carol C %A Burton,André A D %+ College of Healthcare Sciences, James Cook University, 149 Sims Drive, Singapore, 387380, Singapore, 65 67093760, carol.choo@jcu.edu.au %K problem drinking %K alcohol drinking %K eHealth %K telemedicine %K smartphone %K mobile applications %K behavioral intervention %K risk reduction behavior %K review %D 2018 %7 13.02.2018 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: The mobile technology era has ushered in the use of mobile phone apps for behavioral intervention for at-risk drinkers. Objective: Our objective was to review recent research relevant to mobile phone apps that can be used for behavioral intervention for at-risk drinkers in Australia. Methods: The inclusion criteria for this review were articles published in peer-reviewed journals from 2001 to 2017 with use of the search terms “smartphone application,” “alcohol,” “substance,” “behavioural intervention,” “electronic health,” and “mobile health.” Results: In total, we identified 103 abstracts, screened 90 articles, and assessed 50 full-text articles that fit the inclusion criteria for eligibility. We included 19 articles in this review. Conclusions: This review highlighted the paucity of evidence-based and empirically validated research into effective mobile phone apps that can be used for behavioral interventions with at-risk drinkers in Australia. %M 29439946 %R 10.2196/mhealth.6832 %U https://mhealth.jmir.org/2018/2/e18/ %U https://doi.org/10.2196/mhealth.6832 %U http://www.ncbi.nlm.nih.gov/pubmed/29439946 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 2 %P e48 %T Using Relational Agents to Promote Exercise and Sun Protection: Assessment of Participants’ Experiences With Two Interventions %A Sillice,Marie A %A Morokoff,Patricia J %A Ferszt,Ginette %A Bickmore,Timothy %A Bock,Beth C %A Lantini,Ryan %A Velicer,Wayne F %+ Department of of Psychiatry and Human Behavior, Butler Hospital, Brown University, 345 Blackstone Avenue, Potter Building, Office 293, Providence, RI, 02906, United States, 1 401 455 1070, marie_sillice@brown.edu %K relational agents %K eHealth %K exercise %K sun protection %K qualitative methods %D 2018 %7 07.02.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Relational agents (RAs) are electronic computational figures designed to engage participants in the change process. A recent study, Project RAISE, tested the effectiveness of RAs, combined with existing computer-based interventions to increase regular exercise and sun protection behaviors. Results showed these interventions can be effective but need further development. Objective: The purpose of this study was to examine participants’ experiences using RAs to increase participant engagement and promote behavior change . Methods: A qualitative approach was primarily utilized. A 25-question interview guide assessed different components of participants’ experiences with the intervention, including motivation, engagement, satisfaction or dissatisfaction, quality of their interaction with the RA, and behavior change. Quantitative assessment of satisfaction was based on a scale of 1 to 10, with 1 representing least satisfied and 10 representing most satisfied. A summative analytic approach was used to assess individuals’ qualitative responses. A single analysis of variance (ANOVA) examined levels of satisfaction by gender. Results: Of the original 1354 participants enrolled in Project RAISE, 490 of 1354 (36%) were assigned to the RA group. A sample of 216 out of 490 (44%) participants assigned to the RA group completed the interventions, and follow-up assessments were contacted to participate in the semistructured interview. A total of 34 out of 216 (16%) completed the interview. Participants were motivated by, and satisfied with, the intervention. Participants viewed the RA as supportive, informative, caring, and reported positive behavior change in both exercise and sun protection. Some participants (15/34, 44%) noted the RA was less judgmental and less “overbearing” compared with a human counselor; other participants (12/34, 35%) said that the interaction was sometimes repetitive or overly general. The majority of participants (22/34, 65%) viewed the RA as an important contributor to their behavior change for exercise, sun protection, or both. Levels of satisfaction ranged between 7 and 10. There were no gender differences noted in levels of satisfaction (P=.51). Conclusions: RAs provide an innovative and attractive platform to increase exercise and sun protection behaviors and potentially other health behaviors. %M 29415873 %R 10.2196/jmir.7640 %U http://www.jmir.org/2018/2/e48/ %U https://doi.org/10.2196/jmir.7640 %U http://www.ncbi.nlm.nih.gov/pubmed/29415873 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 2 %P e44 %T Effect on the Metabolic Biomarkers in Schoolchildren After a Comprehensive Intervention Using Electronic Media and In-Person Sessions to Change Lifestyles: Community Trial %A Vilchis-Gil,Jenny %A Klünder-Klünder,Miguel %A Flores-Huerta,Samuel %+ Community Health Research Department, Hospital Infantil de México Federico Gómez, Dr Márquez No 162, Ciudad de México, 06720, Mexico, 52 55 5228 9917 ext 4510, floreshuertamd@gmail.com %K obesity %K child %K early intervention (education) %K insulin resistance %K biomarkers %D 2018 %7 05.02.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Obesity is a chronic low-intensity state of inflammation with metabolic alterations that, when acquired during childhood, lead to severe illness in adults. Encouraging healthy eating habits and physical activity is the basis for preventing and treating obesity and its complications. Objective: To evaluate how a comprehensive intervention promoting healthy eating habits and physical activities in schools affects children’s metabolic biomarkers. Methods: Of four Mexico City primary schools in this study, two groups of children that were recruited at their schools were assigned to a 12-month intervention group (IG) and the other two were assigned to control groups (CGs). The intervention had two components: (1) parents/schoolchildren attended in-person educational sessions promoting healthy eating and physical activity habits, and were provided printed information; and (2) parents were able to seek information through a website, and also received brief weekly mobile phone text messages. Anthropometric measurements and fasting blood samples were taken from both groups of children at baseline and again after 12 months. Results: The study involved 187 children in the IG and 128 in the CG. Regardless of each child's nutritional status at the beginning of the study, the intervention improved metabolic parameters; the IG showed a negative effect on glucose concentrations (–1.83; CI 95% –3.06 to -0.60), low-density lipoprotein-cholesterol (–2.59; CI 95% –5.12 to –0.06), insulin (–0.84; CI 95% –1.31 to –0.37), and homeostasis model to assess the insulin resistance index (HOMA-IR; –0.21; CI 95% –0.32 to –0.09) in comparison to the CG. HOMA-IR improved in children who had higher than baseline body mass index z-scores. Conclusions: Intervention through multiple components that promoted healthier eating and physical activity habits improved the metabolic parameters of the children in the study after one year, regardless of their nutritional status. %M 29402762 %R 10.2196/jmir.9052 %U http://www.jmir.org/2018/2/e44/ %U https://doi.org/10.2196/jmir.9052 %U http://www.ncbi.nlm.nih.gov/pubmed/29402762 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 1 %P e42 %T Web-Delivered Cognitive Behavioral Therapy for Distressed Cancer Patients: Randomized Controlled Trial %A Chambers,Suzanne K %A Ritterband,Lee M %A Thorndike,Frances %A Nielsen,Lisa %A Aitken,Joanne F %A Clutton,Samantha %A Scuffham,Paul A %A Youl,Philippa %A Morris,Bronwyn %A Baade,Peter D %A Dunn,Jeff %+ Menzies Health Institute Queensland, Griffith University, Griffith Health Centre, Gold Coast,, Australia, 61 7 5678 8664, suzanne.chambers@griffith.edu.au %K cancer %K mental health %K psychological distress %K randomized controlled trial (RCT) %K health services delivery %D 2018 %7 31.01.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based interventions present a potentially cost-effective approach to supporting self-management for cancer patients; however, further evidence for acceptability and effectiveness is needed. Objective: The goal of our research was to assess the effectiveness of an individualized Web-based cognitive behavioral therapy (CBT) intervention on improving psychological and quality of life outcomes in cancer patients with elevated psychological distress. Methods: A total of 163 distressed cancer patients (111 female, 68.1%) were recruited through the Queensland Cancer Registry and the Cancer Council Queensland Cancer Helpline and randomly assigned to either a Web-based tailored CBT intervention (CancerCope) (79/163) or a static patient education website (84/163). At baseline and 8-week follow-up we assessed primary outcomes of psychological and cancer-specific distress and unmet psychological supportive care needs and secondary outcomes of positive adjustment and quality of life. Results: Intention-to-treat analyses showed no evidence of a statistically significant intervention effect on primary or secondary outcomes. However, per-protocol analyses found a greater decrease for the CancerCope group in psychological distress (P=.04), cancer-specific distress (P=.02), and unmet psychological care needs (P=.03) from baseline to 8 weeks compared with the patient education group. Younger patients were more likely to complete the CancerCope intervention. Conclusions: This online CBT intervention was associated with greater decreases in distress for those patients who more closely adhered to the program. Given the low costs and high accessibility of this intervention approach, even if only effective for subgroups of patients, the potential impact may be substantial. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12613001026718; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364768&isReview=true (Archived by WebCite at http://www.webcitation.org/6uPvpcovl) %M 29386173 %R 10.2196/jmir.8850 %U http://www.jmir.org/2018/1/e42/ %U https://doi.org/10.2196/jmir.8850 %U http://www.ncbi.nlm.nih.gov/pubmed/29386173 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 1 %P e37 %T Implementing a Mobile Health System to Integrate the Treatment of Addiction Into Primary Care: A Hybrid Implementation-Effectiveness Study %A Quanbeck,Andrew %A Gustafson,David H %A Marsch,Lisa A %A Chih,Ming-Yuan %A Kornfield,Rachel %A McTavish,Fiona %A Johnson,Roberta %A Brown,Randall T %A Mares,Marie-Louise %A Shah,Dhavan V %+ Department of Family Medicine and Community Health, University of Wisconsin - Madison, 1100 Delaplaine Ct, Madison, WI, 53715, United States, 1 608 263 4550, arquanbe@wisc.edu %K mobile health %K mHealth %K evidence-based practice %K behavioral medicine %D 2018 %7 30.01.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite the near ubiquity of mobile phones, little research has been conducted on the implementation of mobile health (mHealth) apps to treat patients in primary care. Although primary care clinicians routinely treat chronic conditions such as asthma and diabetes, they rarely treat addiction, a common chronic condition. Instead, addiction is most often treated in the US health care system, if it is treated at all, in a separate behavioral health system. mHealth could help integrate addiction treatment in primary care. Objective: The objective of this paper was to report the effects of implementing an mHealth system for addiction in primary care on both patients and clinicians. Methods: In this implementation research trial, an evidence-based mHealth system named Seva was introduced sequentially over 36 months to a maximum of 100 patients with substance use disorders (SUDs) in each of three federally qualified health centers (FQHCs; primary care clinics that serve patients regardless of their ability to pay). This paper reports on patient and clinician outcomes organized according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Results: The outcomes according to the RE-AIM framework are as follows: Reach—Seva reached 8.31% (268/3226) of appropriate patients. Reach was limited by our ability to pay for phones and data plans for a maximum of 100 patients per clinic. Effectiveness—Patients who were given Seva had significant improvements in their risky drinking days (44% reduction, (0.7-1.25)/1.25, P=.04), illicit drug-use days (34% reduction, (2.14-3.22)/3.22, P=.01), quality of life, human immunodeficiency virus screening rates, and number of hospitalizations. Through Seva, patients also provided peer support to one another in ways that are novel in primary care settings. Adoption—Patients sustained high levels of Seva use—between 53% and 60% of the patients at the 3 sites accessed Seva during the last week of the 12-month implementation period. Among clinicians, use of the technology was less robust than use by patients, with only a handful of clinicians using Seva in each clinic and behavioral health providers making most referrals to Seva in 2 of the 3 clinics. Implementation—At 2 sites, implementation plans were realized successfully; they were delayed in the third. Maintenance—Use of Seva dropped when grant funding stopped paying for the mobile phones and data plans. Two of the 3 clinics wanted to maintain the use of Seva, but they struggled to find funding to support this. Conclusions: Implementing an mHealth system can improve care among primary care patients with SUDs, and patients using the system can support one another in their recovery. Among clinicians, however, implementation requires figuring out how information from the mHealth system will be used and making mHealth data available in the electronic health (eHealth) record. In addition, paying for an mHealth system remains a challenge. %M 29382624 %R 10.2196/jmir.8928 %U http://www.jmir.org/2018/1/e37/ %U https://doi.org/10.2196/jmir.8928 %U http://www.ncbi.nlm.nih.gov/pubmed/29382624 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 1 %P e32 %T Intrapersonal Variation in Goal Setting and Achievement in Health Coaching: Cross-Sectional Retrospective Analysis %A Wallace,Anne M %A Bogard,Matthew T %A Zbikowski,Susan M %+ Wellness Science and Analytics, Humana, Inc, 500 West Main Street, Louisville, KY, 40202, United States, 1 513 768 2615, awallace44@gmail.com %K health coaching %K health risks %K chronic conditions %K behavior change %D 2018 %7 26.01.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic conditions in the United States are among the most costly and preventable of all health problems. Research suggests health coaching is an effective strategy for reducing health risks including decreases in weight, blood pressure, lipids, and blood glucose. Much less is known about how and when coaching works. Objective: The aim of this study was to conduct an analysis of intrapersonal variations in participants’ progression in health coaching, examining gender and age-related differences. Methods: This was a cross-sectional, retrospective analysis of 35,333 health coaching participants between 2012 and 2016. Differences in number of goals and activities set and completed, and number of interactions were assessed using negative binomial models. Differences in goal type were assessed using logistic regression for gender and using the Welch test for age to account for unequal variances. Results: Participants choosing online coaching were more likely to be younger and female (P<.001). Gender and age differences were found for the types of goals set by participants. Regarding program activity, women set and completed 12% more action steps than men (P<.001), averaging 21% more interactions than men (P<.001); no gender differences were found in number of goals completed (P=.12), although the percentage of males and females completing goals was significantly different at 60 and 120 days postenrollment (P<.001). Results indicated significant age-related differences in all aspects of program activity: number of interactions, goals set and completed, action steps set and completed (all P values <.01), as well as significant differences in percentage of individuals completing initial goals within 30 days, with older individuals completing more than younger individuals did (all P values <.001). Conclusions: This study found significant intrapersonal variation in how people participate in and progress through a coaching program. Age-related variations were found in all aspects of coaching activity, from modality preference and initial choice of goal type (eg, weight management, tobacco cessation) to goal completion, whereas gender-related differences were demonstrated for all program activities except number of goals set and completed. These findings indicate that to maximize behavior change, coaches need to personalize the coaching experience to the individual. %M 29374005 %R 10.2196/jmir.8892 %U http://www.jmir.org/2018/1/e32/ %U https://doi.org/10.2196/jmir.8892 %U http://www.ncbi.nlm.nih.gov/pubmed/29374005 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 1 %P e12 %T Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Dental Anxiety: Open Trial %A Shahnavaz,Shervin %A Hedman-Lagerlöf,Erik %A Hasselblad,Tove %A Reuterskiöld,Lena %A Kaldo,Viktor %A Dahllöf,Göran %+ Division of Pediatric Dentistry, Department of Dental Medicine, Karolinska Institutet, Box 4064, 14104, Huddinge,, Sweden, 46 8 52488091, shervin.shahnavaz@ki.se %K cognitive behavioral therapy %K dental fear %K dental phobia %K dentistry %K internet-based treatment %K pediatric dentistry %K psychology %K self efficacy %D 2018 %7 22.01.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Cognitive behavioral therapy (CBT) is an evidence-based method for treating specific phobias, but access to treatment is difficult, especially for children and adolescents with dental anxiety. Psychologist-guided Internet-based CBT (ICBT) may be an effective way of increasing accessibility while maintaining treatment effects. Objective: The aim of this study was to test the hypothesis that psychologist-guided ICBT improves school-aged children’s and adolescents’ ability to manage dental anxiety by (1) decreasing avoidance and affecting the phobia diagnosis and (2) decreasing the dental fear and increasing the target groups’ self-efficacy. The study also aimed to examine the feasibility and acceptability of this novel treatment. Methods: This was an open, uncontrolled trial with assessments at baseline, posttreatment, and the 1-year follow-up. The study enrolled and treated 18 participants. The primary outcome was level of avoidance behaviors, as measured by the picture-guided behavioral avoidance test (PG-BAT). The secondary outcome was a diagnostic evaluation with the parents conducted by a psychologist. The specific phobia section of the structured interview Kiddie-Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime (K-SADS-PL) was used. Other outcome measures included level of dental anxiety and self-efficacy. The ICBT, which employed exposure therapy, comprised 12 modules of texts, animations, dentistry-related video clips, and an exercise package (including dental instruments). Participants accessed the treatment through an Internet-based treatment platform and received Web-based guidance from a psychologist. Treatment also included training at dental clinics. Feasibility and acceptability were assessed by measures of engagement, adherence, compliance, completed measures, patient and parent satisfaction scale, and staff acceptability. Results: The level of avoidance (according to the primary outcome measure PG-BAT) and dental anxiety decreased and self-efficacy increased significantly (P<.001), within-group effect sizes for both the primary outcome (Cohen d=1.5), and other outcomes were large in the range of 0.9 and 1.5. According to K-SADS-PL, 53% (8/15) of the participants were free from diagnosable dental anxiety at the 1-year follow-up. At the 1-year follow-up, improvements were maintained and clinically significant, with 60% (9/15) of participants who had been unable to manage intraoral injection of local anesthetics before ICBT reporting having accomplished this task at a dental clinic. The target group showed improvement in all the outcome measures. High levels of feasibility and acceptability were observed for the treatment. Conclusions: ICBT is a promising and feasible treatment for dental anxiety in children and adolescents. Integrating it into routine pediatric dental care would increase access to an effective psychological treatment. The results of this open trial must be replicated in controlled studies. %M 29358158 %R 10.2196/jmir.7803 %U http://www.jmir.org/2018/1/e12/ %U https://doi.org/10.2196/jmir.7803 %U http://www.ncbi.nlm.nih.gov/pubmed/29358158 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 1 %P e17 %T A Tailored Web-Based Intervention to Improve Parenting Risk and Protective Factors for Adolescent Depression and Anxiety Problems: Postintervention Findings From a Randomized Controlled Trial %A Yap,Marie Bee Hui %A Mahtani,Shireen %A Rapee,Ronald M %A Nicolas,Claire %A Lawrence,Katherine A %A Mackinnon,Andrew %A Jorm,Anthony F %+ Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton, 3800, Australia, 61 399050723, marie.yap@monash.edu %K family %K anxiety %K parenting %K depression %K adolescent %K Internet %K mental health %K preventive health services %D 2018 %7 19.01.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression and anxiety disorders in young people are a global health concern. Parents have an important role in reducing the risk of these disorders, but cost-effective, evidence-based interventions for parents that can be widely disseminated are lacking. Objective: This study aimed to examine the postintervention effects of the Partners in Parenting (PiP) program on parenting risk and protective factors for adolescent depression and anxiety, and on adolescent depression and anxiety symptoms. Methods: A two-arm randomized controlled trial was conducted with 359 parent-adolescent dyads, recruited primarily through schools across Australia. Parents and adolescents were assessed at baseline and 3 months later (postintervention). Parents in the intervention condition received PiP, a tailored Web-based parenting intervention designed following Persuasive Systems Design (PSD) principles to target parenting factors associated with adolescents’ risk for depression and anxiety problems. PiP comprises a tailored feedback report highlighting each parent’s strengths and areas for improvement, followed by a set of interactive modules (up to nine) that is specifically recommended for the parent based on individually identified areas for improvement. Parents in the active-control condition received a standardized package of five Web-based factsheets about adolescent development and well-being. Parents in both conditions received a 5-min weekly call to encourage progress through their allocated program to completion. Both programs were delivered weekly via the trial website. The primary outcome measure at postintervention was parent-reported changes in parenting risk and protective factors, which were measured using the Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS). Secondary outcome measures were the adolescent-report PRADAS, the parent- and child-report Short Mood and Feelings Questionnaire (depressive symptoms), and parent- and child-report Spence Children’s Anxiety Scale (anxiety symptoms). Results: Parents in the intervention condition completed a mean of 73.7% of their intended personalized PiP program. A total of 318 parents (88.6%, 318/359) and 308 adolescents (92.8%, 308/332) completed the postintervention assessment. Attrition was handled using mixed model of repeated measures analysis of variance. As hypothesized, we found a significant condition-by-time interaction on the PRADAS, with a medium effect size, Cohen d=0.57, 95% CI 0.34-0.79. No significant differences between conditions were found at postintervention on any of the secondary outcome measures, with adolescent depressive (parent-report only) and anxiety (both parent- and adolescent-report) symptoms decreasing significantly from baseline to postintervention in both conditions. Conclusions: The fully automated PiP intervention showed promising short-term effects on parenting behaviors that are associated with adolescents’ risk for depression and anxiety. Long-term follow-up is required to ascertain whether these effects translate into reduced adolescent depression and anxiety problems. The intervention may be useful as a low-cost universal public health program to increase parenting practices believed to benefit adolescents’ mental health. Trial Registration: Australia New Zealand Clinical Trials Registry: ACTRN12615000328572; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx? id=368274 (Archived by WebCite at http://www.webcitation.org/6qgsZ3Aqj) %M 29351895 %R 10.2196/jmir.9139 %U http://www.jmir.org/2018/1/e17/ %U https://doi.org/10.2196/jmir.9139 %U http://www.ncbi.nlm.nih.gov/pubmed/29351895 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 1 %P e9 %T Turning Good Intentions Into Actions by Using the Health Action Process Approach to Predict Adherence to Internet-Based Depression Prevention: Secondary Analysis of a Randomized Controlled Trial %A Zarski,Anna-Carlotta %A Berking,Matthias %A Reis,Dorota %A Lehr,Dirk %A Buntrock,Claudia %A Schwarzer,Ralf %A Ebert,David Daniel %+ Friedrich-Alexander-University Erlangen-Nürnberg, Nägelsbachstraße 25a, Erlangen,, Germany, 49 9131 85 67570, Anna-Carlotta.Zarski@fau.de %K health action process approach %K adherence %K Internet intervention %K depression prevention %D 2018 %7 11.01.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Many individuals engaging in Internet-based interventions fail to complete these treatments as intended. The processes responsible for treatment adherence in Internet-based interventions are still poorly understood. Objective: The aim of this study was to investigate to what extent adherence in an Internet-based intervention can be predicted by motivational and volitional factors outlined in the health action process approach (HAPA). Methods: This study investigated motivational and volitional factors included in HAPA in a randomized controlled trial to predict treatment adherence of N=101 individuals with subclinical depression in the intervention group of a depression prevention intervention (GET.ON Mood Enhancer). Adherence was operationalized as the number of completed treatment modules. Using longitudinal structural equation modeling, HAPA variables (motivational, maintenance, and recovery self-efficacy, outcome expectancies, intention, and planning) were assessed at baseline and their associations with adherence 7 weeks later. Results: Planning predicted adherence. Better planning was, in turn, associated with higher levels of maintenance self-efficacy, and the latter significantly affected treatment adherence via planning. The other hypothesized direct associations were not significant. In total, the HAPA variables accounted for 14% of variance in treatment adherence. Conclusions: Planning emerged as the strongest predictor of treatment adherence in highly motivated participants in an Internet-based intervention out of all HAPA variables investigated. Findings are in line with the hypothesis that planning facilitates the translation of good intentions into actions. The findings imply that systematically fostering planning skills and maintenance self-efficacy prior to or during Internet-based interventions would help participants to successfully complete these treatments. Trial Registration: German Clinical Trials Register DRKS00005973; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00005973 (Archived by WebCite at http://www.webcitation.org/6uxCy64sy). %M 29326097 %R 10.2196/jmir.8814 %U https://www.jmir.org/2018/1/e9/ %U https://doi.org/10.2196/jmir.8814 %U http://www.ncbi.nlm.nih.gov/pubmed/29326097 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 1 %P e14 %T Face-to-Face Versus Mobile Versus Blended Weight Loss Program: Randomized Clinical Trial %A Hurkmans,Emalie %A Matthys,Christophe %A Bogaerts,An %A Scheys,Leonie %A Devloo,Karlien %A Seghers,Jan %+ Department of Movement Sciences, University of Leuven, Tervuursevest 101, Leuven,, Belgium, 32 16329048, jan.seghers@kuleuven.be %K obesity %K weight loss %K mobile applications %K diet %D 2018 %7 11.01.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Conventional face-to-face weight loss and weight control programs are very labor intensive for both the patient and the provider. It is unclear to what extent conventional programs can be (partially) completed by mobile health (mHealth) apps. Objective: The aim of this study was to compare the effectiveness of different weight loss programs using a combination of conventional and mobile programs among adults who are overweight (body mass index [BMI]>29 kg/m²). Methods: A single-blinded randomized controlled trial among obese adults was performed from September 2015 to March 2016. The study took place in Leuven, Belgium. Of the 102 eligible (BMI >29 kg/m²) adults, 81 (79%) completed the study. The three intervention groups consisted of a conventional face-to-face weight loss program, a weight loss app program (app group), and a partial face-to-face and partial app program (combi group). All intervention groups received the same advice from a dietician and a physical activity coach during a 12-week period. The control group did not receive any information during the same period. Primary outcomes were weight reduction (5% decrease of baseline weight in kg), BMI, metabolic risk factors, dietary pattern, and physical activity. Results: Significant more participants in all three intervention groups lost at least 5% or more of their weight at baseline compared with the control group. No significant difference was found between the combi group and the conventional group. A trend was found that more participants in the combi group lost 5% or more compared with the app group (19%), P=.06. A significant time x group effect was found for BMI and metabolic risk factors, with the control group having the worst results and the combi group being significantly better with regard to BMI compared with the app group. No significant group x time effects were found for the intake of different food and drinks and moderate to vigorous physical activity (MVPA). Conclusions: The results of this study show that a conventional weight loss program could partially be completed with an mHealth program without affecting the effectiveness. Trial Registration: Clinicaltrials.gov NCT02595671; https://clinicaltrials.gov/ct2/show/NCT02595671 (Archived by WebCite at http://www.webcitation.org/6w1H0x1Q6) %M 29326093 %R 10.2196/mhealth.7713 %U http://mhealth.jmir.org/2018/1/e14/ %U https://doi.org/10.2196/mhealth.7713 %U http://www.ncbi.nlm.nih.gov/pubmed/29326093 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 12 %P e426 %T Efficacy of a Web-Based Safety Decision Aid for Women Experiencing Intimate Partner Violence: Randomized Controlled Trial %A Koziol-McLain,Jane %A Vandal,Alain C %A Wilson,Denise %A Nada-Raja,Shyamala %A Dobbs,Terry %A McLean,Christine %A Sisk,Rose %A Eden,Karen B %A Glass,Nancy E %+ Centre for Interdisciplinary Trauma Research, Faculty of Health and Environmental Sciences, Auckland University of Technology, Private Bag 92006, Auckland, 1142, New Zealand, 64 9 921 9670, jane.koziol-mclain@aut.ac.nz %K eHealth %K intimate partner violence %K randomized controlled trial %K New Zealand %K depression %K population groups %D 2018 %7 10.01.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Intimate partner violence (IPV) is a human rights violation and leading health burden for women. Safety planning is a hallmark of specialist family violence intervention, yet only a small proportion of women access formal services. A Web-based safety decision aid may reach a wide audience of women experiencing IPV and offer the opportunity to prioritize and plan for safety for themselves and their families. Objective: The aim of this study was to test the efficacy of a Web-based safety decision aid (isafe) for women experiencing IPV. Methods: We conducted a fully automated Web-based two-arm parallel randomized controlled trial (RCT) in a general population of New Zealand women who had experienced IPV in the past 6 months. Computer-generated randomization was based on a minimization scheme with stratification by severity of violence and children. Women were randomly assigned to the password-protected intervention website (safety priority setting, danger assessment, and tailored action plan components) or control website (standard, nonindividualized information). Primary endpoints were self-reported mental health (Center for Epidemiologic Studies Depression Scale-Revised, CESD-R) and IPV exposure (Severity of Violence Against Women Scale, SVAWS) at 12-month follow-up. Analyses were by intention to treat. Results: Women were recruited from September 2012 to September 2014. Participants were aged between 16 and 60 years, 27% (111/412) self-identified as Māori (indigenous New Zealand), and 51% (210/412) reported at baseline that they were unsure of their future plans for their partner relationship. Among the 412 women recruited, retention at 12 months was 87%. The adjusted estimated intervention effect for SVAWS was −12.44 (95% CI −23.35 to −1.54) for Māori and 0.76 (95% CI −5.57 to 7.09) for non-Māori. The adjusted intervention effect for CESD-R was −7.75 (95% CI −15.57 to 0.07) for Māori and 1.36 (−3.16 to 5.88) for non-Māori. No study-related adverse events were reported. Conclusions: The interactive, individualized Web-based isafe decision aid was effective in reducing IPV exposure limited to indigenous Māori women. Discovery of a treatment effect in a population group that experiences significant health disparities is a welcome, important finding. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000708853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000708853 (Archived by Webcite at http://www.webcitation/61MGuVXdK) %M 29321125 %R 10.2196/jmir.8617 %U http://www.jmir.org/2017/12/e426/ %U https://doi.org/10.2196/jmir.8617 %U http://www.ncbi.nlm.nih.gov/pubmed/29321125 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 1 %P e1 %T Effect of a Gender-Tailored eHealth Weight Loss Program on the Depressive Symptoms of Overweight and Obese Men: Pre-Post Study %A Young,Myles D %A Morgan,Philip J %+ Priority Research Centre in Physical Activity and Nutrition, University of Newcastle, ATC301, University Drive, Callaghan, 2308, Australia, 61 249216096, myles.young@newcastle.edu.au %K male %K weight loss %K depression %K behavior change %K obesity %K gender-sensitive %D 2018 %7 09.01.2018 %9 Short Paper %J JMIR Ment Health %G English %X Background: Obesity and depression are of two of the largest contributors to the global burden of disease in men. Although lifestyle behavior change programs can improve participants’ weight and depressive symptoms, the evidence is limited by a lack of male participants and a reliance on face-to-face treatment approaches, which are not accessible or appealing for many men. Objective: This study examined the effect of a gender-tailored electronic health (eHealth) program on the depressive symptoms of a community sample of overweight and obese men with or without depression. A secondary aim was to determine whether the eHealth, self-directed format of the program was a feasible and acceptable treatment approach for the subgroup of men with depression at baseline. Methods: In total, 209 overweight/obese men from the Hunter Region of Australia were assessed before and after completing a self-administered eHealth weight loss program over 3 months. To increase engagement, most program elements were socio-culturally targeted to appeal specifically to men and included printed materials, a DVD, motivational text messages, online- or app-based self-monitoring, and other weight loss tools (eg, pedometer). Depressive symptoms were measured with the validated 8-item Patient Health Questionnaire (PHQ-8). Program feasibility and acceptability were assessed with a process questionnaire plus recruitment and retention rates. Changes in depressive symptoms and weight were examined using intention-to-treat linear mixed models, adjusted for the centered baseline score and other covariates. Effect sizes were estimated with Cohen’s d. Results: At baseline, the mean weight and age of the sample was 105.7 kg (standard deviation [SD] 14.0) and 46.6 years (SD 11.3), respectively. Overall, 36 men (36/209, 17.2%) were experiencing depression (PHQ-8 score ≥10). Retention rates were comparable between men with and without depression (32/36, 88.9% vs 145/173, 83.8%; P=.44). At posttest, depressive symptoms had reduced by 1.8 units (95% CI 1.3 to 2.3; P<.001; d=0.5) for the whole sample. These improvements were particularly notable in the subgroup of men with depression (-5.5 units; P<.001; d=1.0) and 72.2% (26/36) of this subgroup no longer met the criterion for depression at posttest. A corresponding, albeit smaller, intervention effect on depressive symptoms was also observed in men without depression (-1.0 units; P<.001; d=0.4). The overall intervention effect on weight was -4.7 kg (d=1.3), which did not vary significantly by depression status. Program acceptability, feasibility, and online engagement metrics were also comparable between men with and without depression. Conclusions: A gender-tailored eHealth lifestyle program generated short-term improvements in the mental health of overweight and obese men, particularly for men with depression at baseline. Despite receiving no personalized support, men with depression reported high levels of satisfaction and engagement with the program. As such, a longer-term controlled trial testing an adapted version of the program for this subgroup is warranted. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12612000749808; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=362575 (Archived by WebCite at http://www.webcitation.org/6wJvbRsNW) %M 29317379 %R 10.2196/mental.8920 %U http://mental.jmir.org/2018/1/e1/ %U https://doi.org/10.2196/mental.8920 %U http://www.ncbi.nlm.nih.gov/pubmed/29317379 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 1 %P e2 %T Importance of Active Participation in Obesity Management Through Mobile Health Care Programs: Substudy of a Randomized Controlled Trial %A Oh,Bumjo %A Yi,Ga-Hye %A Han,Min Kyu %A Kim,Jong Seung %A Lee,Chang Hee %A Cho,Belong %A Kang,Hee Cheol %+ Department of Family Medicine, Seoul Metropolitan Government - Seoul National University Boramae Medical Center, Seoul National University College of Medicine, 20 Boramae-ro 5 gil, Dongjak-gu, Seoul, 07061, Republic Of Korea, 82 2 870 2681, atenae68@nate.com %K physical activity %K mobile health %K metabolic syndrome %K self-report %K adherence %K concordance %D 2018 %7 03.01.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Due to the prevalence of the westernized dietary pattern and lack of physical activity, the numbers of overweight or obese individuals are increasing, resulting in a growing health burden because of various related diseases. A lifestyle modification approach has additional advantages compared with pharmacological therapies or bariatric surgery. In our randomized controlled trial conducted in 2015, we successfully used a ubiquitous health care (SmartCare) service for patients with metabolic syndrome to achieve a significant weight loss effect. Various useful apps have been developed for the SmartCare Service, which involves using a mobile phone to manage chronic diseases, minimizing time and space restrictions. Many studies have demonstrated weight loss effects using a SmartCare service, but limited data are available regarding the effect of active participation in relation to weight loss. Objective: We aimed to assess the weight loss effect achieved after using the SmartCare service in terms of adherence and participation. We divided the intervention group of the previous study according to participation level, and analyzed whether there was a significant difference in the outcome. Methods: We classified participants into 3 groups according to their adherence. Within the intervention group using the SmartCare service, the active group comprised those transmitting anthropometric measurement data using a mobile phone 3 or more times per week or who had a health consultation 5 or more times during a 24-week period. The passive group comprised those who did not adhere to these levels of engagement. The control group comprised those who did not use the SmartCare service. We compared changes in body weight, body mass index (BMI), body fat percentage, waist circumference, and lipid profile among the 3 groups. Results: We identified 422 participants and analyzed 405, excluding 17 who were missing necessary data for analysis. The active group consisted of 116 participants, compared with 80 in the passive group and 209 in the control group (without SmartCare service). There was a statistically significant difference in improvements to body weight, BMI, body fat percentage, and waist circumference among active participants compared with less active participants and the control group (P<.05). However, the lipid profile changes did not differ significantly between groups. Conclusions: The level of participation may be related to improved weight-related outcomes, which may improve health outcomes. To maximize the effectiveness of the SmartCare service, encouraging active participation is important. Trial Registration: Clinicaltrials.gov NCT01344811; https://clinicaltrials.gov/ct2/show/NCT01344811 (Archived by WebCite at http://www.webcitation.org/6alT2MmIB) %M 29298749 %R 10.2196/mhealth.8719 %U http://mhealth.jmir.org/2018/1/e2/ %U https://doi.org/10.2196/mhealth.8719 %U http://www.ncbi.nlm.nih.gov/pubmed/29298749 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 1 %P e1 %T A Perioperative eHealth Program to Enhance Postoperative Recovery After Abdominal Surgery: Process Evaluation of a Randomized Controlled Trial %A van der Meij,Eva %A Huirne,Judith AF %A ten Cate,A Dorien %A Stockmann,Hein BAC %A Scholten,Piet C %A Davids,Paul HP %A Bonjer,H Jaap %A Anema,Johannes R %+ Amsterdam Public Health Research Institute, Department of Public and Occupational Health, VU University Medical Center, van der Boechorststraat 7, 1081 BT, Amsterdam,, Netherlands, 31 204450703, ev.vandermeij@vumc.nl %K telemedicine %K cholecystectomy %K surgical procedures, operative %K perioperative care %K convalescence %K process assessment %D 2018 %7 02.01.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Electronic health (eHealth) interventions have proven effective, but implementation in clinical practice is difficult. More research focusing on the implementation process of eHealth interventions is necessary. Objective: The objective of this study was to describe the process evaluation of a perioperative eHealth intervention, aiming to enhance recovery after laparoscopic abdominal surgery. Methods: A process evaluation was carried out alongside a multicenter randomized controlled trial. Patients aged between 18 and 75 years who were scheduled for a laparoscopic cholecystectomy, hernia inguinal surgery, or laparoscopic adnexal surgery were included. The eHealth intervention comprised a website and mobile phone app with the possibility to develop a personalized convalescence plan, a section with information about the surgical procedure and the recovery period, the possibility to ask questions via an electronic consultation (eConsult), and an activity tracker. The process evaluation was carried out using the model of Linnan and Steckler, measuring components such as reach, dose delivered, dose received, fidelity, and participants’ attitudes. Implementation scores were calculated based on the average of the four components. Quantitative data were collected by means of an electronic questionnaire, a logistic database, a weblog, and medical files. Qualitative data were collected by conducting interviews with a subsample of the study participants. Results: A total of 344 of the 863 eligible patients were included in the study, which accounted for a reach of 39.9%, and 173 participants were randomized to the intervention group. The implementation scores of the different functions of the intervention ranged between 60% and 65%. The website, mobile phone app, and activity tracker were rated 7.3 to 7.6 on a scale of 1 to 10. Almost all participants who were interviewed about the eConsult function rated it as being of additional value if combined with the usual care but not as a replacement for usual care. Conclusions: Although participants were overall satisfied with the intervention, the implementation scores of the different functions of the intervention were fair. More research is needed to evaluate the barriers and facilitators for implementation of this perioperative eHealth intervention in normal practice outside study setting. Trial Registration: Netherlands Trial Registry NTR4699; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4699 (Archived by WebCite at http://www.webcitation.org/6vr02V4KK) %M 29295808 %R 10.2196/jmir.8338 %U http://www.jmir.org/2018/1/e1/ %U https://doi.org/10.2196/jmir.8338 %U http://www.ncbi.nlm.nih.gov/pubmed/29295808 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 12 %P e418 %T Blended Interventions to Change Behavior in Patients With Chronic Somatic Disorders: Systematic Review %A Kloek,Corelien %A Bossen,Daniël %A de Bakker,Dinny H %A Veenhof,Cindy %A Dekker,Joost %+ Tranzo, Tilburg University, Warandelaan 2, Tilburg, 5037 AB, Netherlands, 31 884812546, corelien.kloek@hu.nl %K telemedicine %K chronic disease %K behavior %D 2017 %7 21.12.2017 %9 Review %J J Med Internet Res %G English %X Background: Blended behavior change interventions combine therapeutic guidance with online care. This new way of delivering health care is supposed to stimulate patients with chronic somatic disorders in taking an active role in their disease management. However, knowledge about the effectiveness of blended behavior change interventions and how they should be composed is scattered. Objective: This comprehensive systematic review aimed to provide an overview of characteristics and effectiveness of blended behavior change interventions for patients with chronic somatic disorders. Methods: We searched for randomized controlled trials published from 2000 to April 2017 in PubMed, Embase, CINAHL, and Cochrane Central Register of Controlled Trials. Risk of bias was assessed using the Cochrane Collaboration tool. Study characteristics, intervention characteristics, and outcome data were extracted. Studies were sorted based on their comparison group. A best-evidence synthesis was conducted to summarize the effectiveness. Results: A total of 25 out of the 29 included studies were of high quality. Most studies (n=21; 72%) compared a blended intervention with no intervention. The majority of interventions focused on changing pain behavior (n=17; 59%), and the other interventions focused on lifestyle change (n=12; 41%). In addition, 26 studies (90%) focused on one type of behavior, whereas 3 studies (10%) focused on multiple behaviors. A total of 23 studies (79%) mentioned a theory as basis for the intervention. The therapeutic guidance in most studies (n=18; 62%) was non face-to-face by using email, phone, or videoconferencing, and in the other studies (partly), it was face-to-face (n=11; 38%). In 26 studies (90%), the online care was provided via a website, and in 3 studies (10%) via an app. In 22 studies (76%), the therapeutic guidance and online care were integrated instead of two separate aspects. A total of 26 outcome measures were included in the evidence synthesis comparing blended interventions with no intervention: for the coping strategy catastrophizing, we found strong evidence for a significant effect. In addition, 1 outcome measure was included in the evidence synthesis comparing blended interventions with face-to-face interventions, but no evidence for a significant effect was found. A total of 6 outcome measures were included in the evidence synthesis comparing blended interventions with online interventions, but no evidence for a significant effect was found. Conclusions: Blended behavior change interventions for patients with chronic somatic disorders show variety in the type of therapeutic guidance, the type of online care, and how these two delivery modes are integrated. The evidence of the effectiveness of blended interventions is inconsistent and nonsignificant for most outcome measures. Future research should focus on which type of blended intervention works for whom. %M 29269338 %R 10.2196/jmir.8108 %U http://www.jmir.org/2017/12/e418/ %U https://doi.org/10.2196/jmir.8108 %U http://www.ncbi.nlm.nih.gov/pubmed/29269338 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 12 %P e423 %T Implementation of the Blended Care Self-Management Program for Caregivers of People With Early-Stage Dementia (Partner in Balance): Process Evaluation of a Randomized Controlled Trial %A Boots,Lizzy MM %A de Vugt,Marjolein E %A Smeets,Claudia MJ %A Kempen,Gertrudis IJM %A Verhey,Frans RJ %+ Department of Psychiatry and Neuropsychology, Alzheimer Center Limburg, School for Mental Health and Neurosciences, Maastricht University Medical Center+, Faculty of Health, Medicine and Life Sciences, PO Box 616, Maastricht, 6200 MD, Netherlands, 31 43 3881994, l.boots@maastrichtuniversity.nl %K internet %K caregivers %K technology %K therapeutics %D 2017 %7 19.12.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Caring for a family member with dementia puts caregivers at risk of overburdening. Electronic health (eHealth) support for caregivers offers an opportunity for accessible tailored interventions. The blended care self-management program “Partner in Balance” (PiB) for early-stage dementia caregivers was executed in Dutch dementia care organizations. The program combines face-to-face coaching with tailored Web-based modules. Next to an evaluation of program effectiveness, an evaluation of sampling and intervention quality is essential for the generalizability and interpretation of results. Objective: The aim of this study was to describe the process evaluation from the perspective of both family caregivers (participants) and professionals delivering the intervention (coaches) to determine internal and external validity before the effect analysis and aid future implementation. Methods: Implementation, sampling, and intervention quality were evaluated with quantitative and qualitative data from logistical research data, coach questionnaires (n=13), and interviews with coaches (n=10) and participants (n=49). Goal attainment scaling was used to measure treatment-induced change. Analyses were performed with descriptive statistics and deductive content analysis. Results: The participation rate of eligible caregivers was 51.9% (80/154). Recruitment barriers were lack of computer and lack of need for support. Young age and employment were considered recruitment facilitators. All coaches attended training and supervision in blended care self-management. Deviations from the structured protocol were reported on intervention time, structure, and feedback. Coaches described an intensified relationship with the caregiver post intervention. Caregivers appreciated the tailored content and positive feedback. The blended structure increased their openness. The discussion forum was appreciated less. Overall, personal goals were attained after the program (T>50). Implementation barriers included lack of financing, time, and deviating target population. Conclusions: Participants and coaches were satisfied with the intervention, but adapting the content to specific subgroups, for example, younger caregivers, was recommended. Implementation of the program requires more awareness of the benefits of blended care self-management programs and training in tailored self-management skills. Trial Registration: Dutch Trial Register (NTR): NTR4748; http://www.trialregister.nl (Archived by WebCite at http://www.webcitation.org/6vSb2t9Mg) %M 29258980 %R 10.2196/jmir.7666 %U http://www.jmir.org/2017/12/e423/ %U https://doi.org/10.2196/jmir.7666 %U http://www.ncbi.nlm.nih.gov/pubmed/29258980 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 12 %P e422 %T A 6-Week Web-Based Osteoarthritis Treatment Program: Observational Quasi-Experimental Study %A Nero,Håkan %A Dahlberg,Jakob %A Dahlberg,Leif E %+ Orthopaedics, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Department of Orthopaedics, Skåne University Hospital, Lund, 22185, Sweden, 46 46 17 15 37, hakan.nero@med.lu.se %K digital treatment %K eHealth %K telemedicine %K osteoarthritis %K pain %K physical function %D 2017 %7 18.12.2017 %9 Short Paper %J J Med Internet Res %G English %X Background: Osteoarthritis (OA) is one of the most common causes of disability, with a burden of disease estimated to increase over time. Joint Academy, a Web-based treatment for individuals with clinically verified knee or hip OA, was developed to increase access to and facilitate implementation of evidence-based nonsurgical OA treatment in accordance with international guidelines. Objective: The primary aim of this study was to evaluate joint pain, physical function, and health-related quality of life (HRQoL) over time of users of the Joint Academy program. Methods: We enrolled 350 patients who were recruited online and completed the initial health journal in the 6-week program. We asked patients to complete an eHealth journal and e-questionnaires, including pain level assessed by a numerical rating scale, as well as a physical function evaluation using the 30-second chair-stand test. In addition, we assessed HRQoL using the 3-level version of the EQ-5D. We also asked participants whether they experienced difficulty walking and were afraid of physical activity due to their OA and their desire for surgery. We collected descriptive data and compared pre- versus postintervention data. As a reference group, we included results retrieved from the Swedish well-structured face-to-face self-supportive OA management program Better Management of Patients With Osteoarthritis (BOA). Results: Of the study cohort (n=350 patients; 239 women, mean age 62 years, mean body mass index 27 kg/m2), 71.4% (n=250) completed the program and were included in the study. We used the questionnaires to secure a clinical diagnosis of OA and to establish baseline study values. After 6 weeks of treatment, the change in mean numerical rating scale was larger than the minimal clinical difference (5.4 vs 4.1; P<.001), while physical function increased (from 10.88 to 13.14; P<.001). The percentage of participants having walking difficulties decreased from 81.7% (196/240) to 62.1% (149/240; P<.001), those afraid of being physically active decreased from 22.1% (53/240) to 6.7% (16/240; P<.001), and 22.0% (55/250) reported that they had reduced the amount of OA-related medication. After 6 weeks, 24% (13/54) of those desiring surgery at the start of the program were no longer interested. In addition, the comparison between Joint Academy and the BOA program showed similar levels of pain at 3 months, but suggested greater reduction with the use of Joint Academy due to a higher level of pain at baseline. Conclusions: The reported data suggest that participation in Joint Academy is associated with a clinically relevant decrease in pain and an increase in physical function and HRQoL, as well as a decreasing fear of physical activity. This innovative Web-based OA treatment is scalable, is population specific, and can reach a large number of individuals with impaired joints who have Internet access. %M 29254906 %R 10.2196/jmir.9255 %U http://www.jmir.org/2017/12/e422/ %U https://doi.org/10.2196/jmir.9255 %U http://www.ncbi.nlm.nih.gov/pubmed/29254906 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 12 %P e231 %T Direct to Public Peer Support and e-Therapy Program Versus Information to Aid Self-Management of Depression and Anxiety: Protocol for a Randomized Controlled Trial %A Kaylor-Hughes,Catherine J %A Rawsthorne,Mat %A Coulson,Neil S %A Simpson,Sandra %A Simons,Lucy %A Guo,Boliang %A James,Marilyn %A Moran,Paul %A Simpson,Jayne %A Hollis,Chris %A Avery,Anthony J %A Tata,Laila J %A Williams,Laura %A , %A Morriss,Richard K %+ National Institute for Health Research: Collaboration for Leadership in Applied Health Research and Care East Midlands, University of Nottingham, Institute of Mental Health Building, Triumph Road, Nottingham, NG7 2TU, United Kingdom, 44 01158232478, richard.morriss@nottingham.ac.uk %K depression %K anxiety %K peer support %K online %K self-management %D 2017 %7 18.12.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Regardless of geography or income, effective help for depression and anxiety only reaches a small proportion of those who might benefit from it. The scale of the problem suggests a role for effective, safe, anonymized public health–driven Web-based services such as Big White Wall (BWW), which offer immediate peer support at low cost. Objective: Using Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) methodology, the aim of this study was to determine the population reach, effectiveness, cost-effectiveness, and barriers and drivers to implementation of BWW compared with Web-based information compiled by UK’s National Health Service (NHS, NHS Choices Moodzone) in people with probable mild to moderate depression and anxiety disorder. Methods: A pragmatic, parallel-group, single-blind randomized controlled trial (RCT) is being conducted using a fully automated trial website in which eligible participants are randomized to receive either 6 months access to BWW or signposted to the NHS Moodzone site. The recruitment of 2200 people to the study will be facilitated by a public health engagement campaign involving general marketing and social media, primary care clinical champions, health care staff, large employers, and third sector groups. People will refer themselves to the study and will be eligible if they are older than 16 years, have probable mild to moderate depression or anxiety disorders, and have access to the Internet. Results: The primary outcome will be the Warwick-Edinburgh Mental Well-Being Scale at 6 weeks. We will also explore the reach, maintenance, cost-effectiveness, and barriers and drivers to implementation and possible mechanisms of actions using a range of qualitative and quantitative methods. Conclusions: This will be the first fully digital trial of a direct to public online peer support program for common mental disorders. The potential advantages of adding this to current NHS mental health services and the challenges of designing a public health campaign and RCT of two digital interventions using a fully automated digital enrollment and data collection process are considered for people with depression and anxiety. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 12673428; http://www.controlled-trials.com/ISRCTN12673428/12673428 (Archived by WebCite at http://www.webcitation.org/6uw6ZJk5a) %M 29254909 %R 10.2196/resprot.8061 %U http://www.researchprotocols.org/2017/12/e231/ %U https://doi.org/10.2196/resprot.8061 %U http://www.ncbi.nlm.nih.gov/pubmed/29254909 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 12 %P e407 %T Mindfulness-Based Cognitive Therapy for Cancer Patients Delivered via Internet: Qualitative Study of Patient and Therapist Barriers and Facilitators %A Compen,Félix R %A Bisseling,Else M %A Schellekens,Melanie PJ %A Jansen,Ellen TM %A van der Lee,Marije L %A Speckens,Anne EM %+ Centre for Mindfulness, Department of Psychiatry, Radboud University Medical Centre, Reinier Postlaan, Postbus 9101, Nijmegen, 6500HB, Netherlands, 31 243610405, felix.compen@radboudumc.nl %K mindfulness %K psycho-oncology %K cancer survivors %K telemedicine %K qualitative research %D 2017 %7 18.12.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: The number of patients living with cancer is growing, and a substantial number of patients suffer from psychological distress. Mindfulness-based interventions (MBIs) seem effective in alleviating psychological distress. Unfortunately, several cancer patients find it difficult, if not impossible, to attend a group-based course. Internet-based MBIs (eMBIs) such as Internet-based mindfulness-based cognitive therapy (eMBCT) may offer solutions. However, it is yet to be studied what facilitators and barriers cancer patients experience during eMBCT. Objective: This study aimed to explore facilitators and barriers of individual asynchronous therapist-assisted eMBCT as experienced by both patients and therapists. Methods: Patients with heterogeneous cancer diagnoses suffering from psychological distress were offered eMBCT. This 9-week intervention mirrored the group-based MBCT protocol and included weekly asynchronous written therapist feedback. Patients were granted access to a website that contained the eMBCT protocol and a secured inbox, and they were asked to practice and fill out diaries on which the therapist provided feedback. In total, 31 patients participated in an individual posttreatment interview on experienced facilitators and barriers during eMBCT. Moreover, eight therapists were interviewed. The data were analyzed with qualitative content analysis to identify barriers and facilitators in eMBCT. Results: Both patients and therapists mentioned four overarching themes as facilitators and barriers: treatment setting (the individual and Internet-based nature of the treatment), treatment format (how the treatment and its guidance were organized and delivered), role of the therapist, and individual patient characteristics. Conclusions: The eMBCT provided flexibility in when, where, and how patients and therapists engage in MBCT. Future studies should assess how different eMBCT designs could further improve barriers that were found. %M 29254912 %R 10.2196/jmir.7783 %U http://www.jmir.org/2017/12/e407/ %U https://doi.org/10.2196/jmir.7783 %U http://www.ncbi.nlm.nih.gov/pubmed/29254912 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 11 %P e396 %T Implementation of a Web-Based Organ Donation Educational Intervention: Development and Use of a Refined Process Evaluation Model %A Redmond,Nakeva %A Harker,Laura %A Bamps,Yvan %A Flemming,Shauna St. Clair %A Perryman,Jennie P %A Thompson,Nancy J %A Patzer,Rachel E %A Williams,Nancy S DeSousa %A Arriola,Kimberly R Jacob %+ Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, GCR 426, Atlanta, GA, 30322, United States, 1 4047272386, nakevar@gmail.com %K Internet %K intervention %K evaluation methodology %K program evaluation %K research techniques %K organ donation %K health education %D 2017 %7 30.11.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: The lack of available organs is often considered to be the single greatest problem in transplantation today. Internet use is at an all-time high, creating an opportunity to increase public commitment to organ donation through the broad reach of Web-based behavioral interventions. Implementing Internet interventions, however, presents challenges including preventing fraudulent respondents and ensuring intervention uptake. Although Web-based organ donation interventions have increased in recent years, process evaluation models appropriate for Web-based interventions are lacking. Objective: The aim of this study was to describe a refined process evaluation model adapted for Web-based settings and used to assess the implementation of a Web-based intervention aimed to increase organ donation among African Americans. Methods: We used a randomized pretest-posttest control design to assess the effectiveness of the intervention website that addressed barriers to organ donation through corresponding videos. Eligible participants were African American adult residents of Georgia who were not registered on the state donor registry. Drawing from previously developed process evaluation constructs, we adapted reach (the extent to which individuals were found eligible, and participated in the study), recruitment (online recruitment mechanism), dose received (intervention uptake), and context (how the Web-based setting influenced study implementation) for Internet settings and used the adapted model to assess the implementation of our Web-based intervention. Results: With regard to reach, 1415 individuals completed the eligibility screener; 948 (67.00%) were determined eligible, of whom 918 (96.8%) completed the study. After eliminating duplicate entries (n=17), those who did not initiate the posttest (n=21) and those with an invalid ZIP code (n=108), 772 valid entries remained. Per the Internet protocol (IP) address analysis, only 23 of the 772 valid entries (3.0%) were within Georgia, and only 17 of those were considered unique entries and could be considered for analyses. With respect to recruitment, 517 of the 772 valid entries (67.0%) of participants were recruited from a Web recruiter. Regarding dose received, no videos from the intervention website were watched in their entirety, and the average viewing duration was 17 seconds over the minimum. With respect to context, context analysis provided us with valuable insights into factors in the Internet environment that may have affected study implementation. Although only active for a brief period of time, the Craigslist website advertisement may have contributed the largest volume of fraudulent responses. Conclusions: We determined fraud and low uptake to be serious threats to this study and further confirmed the importance of conducting a process evaluation to identify such threats. We suggest checking participants’ IP addresses before study initiation, selecting software that allows for automatic duplicate protection, and tightening minimum requirements for intervention uptake. Further research is needed to understand how process evaluation models can be used to monitor implementation of Web-based studies. %M 29191799 %R 10.2196/jmir.8501 %U http://www.jmir.org/2017/11/e396/ %U https://doi.org/10.2196/jmir.8501 %U http://www.ncbi.nlm.nih.gov/pubmed/29191799 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 11 %P e377 %T Reduction in Vegetable Intake Disparities With a Web-Based Nutrition Education Intervention Among Lower-Income Adults in Japan: Randomized Controlled Trial %A Nakamura,Saki %A Inayama,Takayo %A Harada,Kazuhiro %A Arao,Takashi %+ Department of Health Promotion Sciences, Graduate School of Human Health Sciences, Tokyo Metropolitan University, Minami-Osawa 1-1, Hachioji, Tokyo, 192-0397, Japan, 81 426771111 ext 4664, tinayama@tmu.ac.jp %K vegetable intake %K adults %K socioeconomic disadvantage %K Web-based nutrition intervention %K randomized controlled trial %D 2017 %7 24.11.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: No existing Web-based nutrition education interventions have been evaluated in light of socioeconomic status just in Japan. Objective: The aim was to investigate the effect of a Web-based intervention program on reducing vegetable intake disparities between low- and middle-income Japanese adults. Methods: In this randomized controlled trial, participants were assessed at three time points—baseline, postintervention (5 weeks later), and a follow-up after 3 months—from October 2015 to March 2016. We collected data via a Japanese online research service company from 8564 adults aged 30 to 59 years. Participants were stratified according to national population statistics for gender and age, and randomly selected. They were then randomly allocated into intervention (n=900) and control (n=600) groups such that both groups contained an equal number of individuals with low and middle income. The intervention program encouraged behavior change using behavioral theories and techniques tailored to their assumed stage of change. The outcome was vegetable intake servings per day (1 serving being approximately 70 g). Results: Out of 900 participants who started, 450 were from the middle income group (of which 386 or 85.7% completed the intervention), and 450 were from the low income group (of which 371 or 82.4% completed). In the intervention group, vegetable intake increased in the low-income participants from baseline to postintervention (0.42 servings, 95% CI 0.11-0.72). A two-way analysis of variance showed that low-income participants had significant main effects of group (η2=0.04, P=.01) and time (η2=0.01, P<.001), and a significant interaction (η2=0.01, P=.009). Middle-income participants also had a significant main effect of time (η2=0.01, P=.006) and a significant interaction (η2=0.01, P=.046). Conclusions: This Web-based nutritional education intervention could fill the vegetable intake gap between low- and middle-income adults in Japan, and is expected to prevent noncommunicable and lifestyle-related diseases. Further intervention program improvements are necessary to maintain and increase vegetable intake for other groups. Trial Registration: Current Controlled Trials (UMIN-ICDR): UMIN000019376; https://upload.umin.ac.jp/cgi-open-bin/ icdr_e/ctr_view.cgi?recptno=R000022404 (Archived by WebCite at http://www.webcitation.org/6u9wihBZU) %M 29175810 %R 10.2196/jmir.8031 %U http://www.jmir.org/2017/11/e377/ %U https://doi.org/10.2196/jmir.8031 %U http://www.ncbi.nlm.nih.gov/pubmed/29175810 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 11 %P e398 %T Two Novel Cognitive Behavioral Therapy–Based Mobile Apps for Agoraphobia: Randomized Controlled Trial %A Christoforou,Marina %A Sáez Fonseca,José Andrés %A Tsakanikos,Elias %+ Department of Psychology, University of Roehampton, Holybourne Avenue, London, SW15 4JD, United Kingdom, 44 020 8392 3080, elias.tsakanikos@roehampton.ac.uk %K agoraphobia %K anxiety %K eHealth %K computerized interventions %K mobile applications %K randomized controlled trial %K RCT %D 2017 %7 24.11.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite the large body of literature demonstrating the effectiveness of cognitive behavioral treatments for agoraphobia, many patients remain untreated because of various barriers to treatment. Web-based and mobile-based interventions targeting agoraphobia may provide a solution to this problem, but there is a lack of research investigating the efficacy of such interventions. Objective: The objective of our study was to evaluate for the first time the effectiveness of a self-guided mobile-based intervention primarily targeting agoraphobic symptoms, with respect to a generic mobile app targeting anxiety. Methods: A Web-based randomized controlled trial (RCT) compared a novel mobile app designed to target agoraphobia (called Agoraphobia Free) with a mobile app designed to help with symptoms of anxiety in general (called Stress Free). Both interventions were based on established cognitive behavioral principles. We recruited participants (N=170) who self-identified as having agoraphobia and assessed them online at baseline, midpoint, and end point (posttreatment) over a period of 12 weeks. The primary outcome was symptom severity measured by the Panic and Agoraphobia Scale. Results: Both groups had statistically significant improvements in symptom severity over time (difference –5.97, 95% CI –8.49 to –3.44, P<.001 for Agoraphobia Free and –6.35, 95% CI –8.82 to –3.87, P<.001 for Stress Free), but there were no significant between-group differences on the primary outcome (difference 0.38, 95% CI –1.96 to 3.20, P=.64). Conclusions: This is, to our knowledge, the first RCT to provide evidence that people who identify as having agoraphobia may equally benefit from a diagnosis-specific and a transdiagnostic mobile-based intervention. We also discuss clinical and research implications for the development and dissemination of mobile mental health apps. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 98453199; http://www.isrctn.com /ISRCTN98453199 (Archived by WebCite at http://www.webcitation.org/6uR5vsdZw) %M 29175809 %R 10.2196/jmir.7747 %U http://www.jmir.org/2017/11/e398/ %U https://doi.org/10.2196/jmir.7747 %U http://www.ncbi.nlm.nih.gov/pubmed/29175809 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 11 %P e383 %T Self-Guided Web-Based Interventions: Scoping Review on User Needs and the Potential of Embodied Conversational Agents to Address Them %A Scholten,Mark R %A Kelders,Saskia M %A Van Gemert-Pijnen,Julia EWC %+ Centre for eHealth & Wellbeing Research, Department of Psychology, Health and Technology, University of Twente, Drienerlolaan 5, Enschede, 7522 NB, Netherlands, 31 651409623, m.r.scholten@utwente.nl %K eHealth %K review %K embodied conversational agent %K human computer interaction %K clinical psychology %K health behavior %K Web-based intervention %K adherence %K intelligent tutoring system %K ITS %D 2017 %7 16.11.2017 %9 Review %J J Med Internet Res %G English %X Background: Web-based mental health interventions have evolved from innovative prototypes to evidence-based and clinically applied solutions for mental diseases such as depression and anxiety. Open-access, self-guided types of these solutions hold the promise of reaching and treating a large population at a reasonable cost. However, a considerable factor that currently hinders the effectiveness of these self-guided Web-based interventions is the high level of nonadherence. The absence of a human caregiver apparently has a negative effect on user adherence. It is unknown to what extent this human support can be handed over to the technology of the intervention to mitigate this negative effect. Objective: The first objective of this paper was to explore what is known in literature about what support a user needs to stay motivated and engaged in an electronic health (eHealth) intervention that requires repeated use. The second objective was to explore the current potential of embodied conversational agents (ECAs) to provide this support. Methods: This study reviews and interprets the available literature on (1) support within eHealth interventions that require repeated use and (2) the potential of ECAs by means of a scoping review. The rationale for choosing a scoping review is that the subject is broad, diverse, and largely unexplored. Themes for (1) and (2) were proposed based on grounded theory and mapped on each other to find relationships. Results: The results of the first part of this study suggest the presence of user needs that largely remain implicit and unaddressed. These support needs can be categorized as task-related support and emotion-related support. The results of the second part of this study suggest that ECAs are capable of engaging and motivating users of information technology applications in the domains of learning and behavioral change. Longitudinal studies must be conducted to determine under what circumstances ECAs can create and maintain a productive user relationship. Mapping the user needs on the ECAs’ capabilities suggests that different kinds of ECAs may provide different solutions for improving the adherence levels. Conclusions: Autonomous ECAs that do not respond to a user’s expressed emotion in real time but take on empathic roles may be sufficient to motivate users to some extent. It is unclear whether those types of ECAs are competent enough and create sufficient believability among users to address the user’s deeper needs for support and empathy. Responsive ECAs may offer a better solution. However, at present, most of these ECAs have difficulties to assess a user’s emotional state in real time during an open dialogue. By conducting future research with relationship theory–based ECAs, the added value of ECAs toward user needs can be better understood. %M 29146567 %R 10.2196/jmir.7351 %U http://www.jmir.org/2017/11/e383/ %U https://doi.org/10.2196/jmir.7351 %U http://www.ncbi.nlm.nih.gov/pubmed/29146567 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 4 %N 4 %P e54 %T Exploring Working Relationships in Mental Health Care via an E-Recovery Portal: Qualitative Study on the Experiences of Service Users and Health Providers %A Strand,Monica %A Gammon,Deede %A Eng,Lillian Sofie %A Ruland,Cornelia %+ Centre for Shared Decision-Making and Collaborative Care Research, Oslo University Hospital, Sogn Arena Pb. 4950 Nydalen, N-0424 Oslo, Oslo,, Norway, 1 004790977963, deede.gammon@rr-research.no %K eHealth %K recovery %K mental health %K psychiatry %K user involvement %K empowerment %K working relationship %K secure email %K e-recovery %K participatory research %D 2017 %7 14.11.2017 %9 Original Paper %J JMIR Ment Health %G English %X Background: The quality of working relationships between service users and health providers is fundamental in the processes of recovery in mental health. How Internet-based interventions will influence these relationships for persons with long-term care needs, and the measures that can be taken to maintain and enhance working relationships through Internet, is still not well understood. Objective: The aim of this study was to gain insights into how service users and health providers experience their working relationships when they are offered the option of supplementing ongoing collaboration with an e-recovery portal. Methods: In this exploratory and descriptive study, an e-recovery portal was used by service users and their health providers in 2 mental health communities in Norway for at least 6 months and at most 12 months (2015-2016). The portal consists of secure messaging, a peer support forum, and a toolbox of resources for working with life domains including status, goals and activities, network map, crisis plan, and exercises. The portal was owned and managed by the service user while health providers could remotely access parts of the service user–generated content. The participants could use the portal in whatever way they wished, to suit their collaboration. Data from 6 focus groups, 17 individual interviews, and an interview with 1 dyad about their experiences of use of the portal over the study period were inductively coded and thematically analyzed. Results: The thematic analysis resulted in 2 main themes: (1) new relational avenues and (2) out of alignment, illustrated by 8 subthemes. The first main theme is about dyads who reported new and enriching ways of working together through the portal, particularly related to written communication and use of the goal module. Illustrative subthemes are ownership, common ground, goals and direction, and sense of presence and availability. The second main theme illuminates the difficulties that arose when service users’ and health providers’ expectations for portal use were not aligned, and the consequences of not addressing these difficulties. Illustrative subthemes are initiative and responsibility, waiting for the other, feeling overwhelmed, and clarifications and agreements. Conclusions: The degree to which dyads benefited from using the e-recovery portal appeared to be mainly associated with the degree to which the dyads’ relations were open and flexible before the portal was introduced. For those who experienced frustrations, the portal may have both exposed and added to suboptimal working relationships. Use of the goal module appeared to strengthen the person-centered nature of collaboration. A key question is how health providers balance between enabling service users’ greater control over their care, without relinquishing responsibility for the quality of the working relationship, also when using an e-recovery portal. Implications for implementation are discussed. %M 29138127 %R 10.2196/mental.8491 %U http://mental.jmir.org/2017/4/e54/ %U https://doi.org/10.2196/mental.8491 %U http://www.ncbi.nlm.nih.gov/pubmed/29138127 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 11 %P e354 %T Reducing Symptom Distress in Patients With Advanced Cancer Using an e-Alert System for Caregivers: Pooled Analysis of Two Randomized Clinical Trials %A Gustafson,David H %A DuBenske,Lori L %A Atwood,Amy K %A Chih,Ming-Yuan %A Johnson,Roberta A %A McTavish,Fiona %A Quanbeck,Andrew %A Brown,Roger L %A Cleary,James F %A Shah,Dhavan %+ Center for Health Enhancement Systems Studies, Department of Industrial and Systems Engineering, University of Wisconsin-Madison, Mechanical Engineering Building, 4th Floor, 1513 University Ave., Madison, WI, 53706, United States, 1 6082395535, dhgustaf@wisc.edu %K Internet %K health communication %K palliative care %K communication barriers %K signs and symptoms %K eHealth %D 2017 %7 14.11.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Symptom distress in patients toward the end of life can change rapidly. Family caregivers have the potential to help patients manage those symptoms, as well as their own stress, if they are equipped with the proper resources. Electronic health (eHealth) systems may be able to provide those resources. Very sick patients may not be able to use such systems themselves to report their symptoms but family caregivers could. Objective: The aim of this paper was to assess the effects on cancer patient symptom distress of an eHealth system that alerts clinicians to significant changes in the patient’s symptoms, as reported by a family caregiver. Methods: A pooled analysis from two randomized clinical trials (NCT00214162 and NCT00365963) compared outcomes at 12 months for two unblinded groups: a control group (Comprehensive Health Enhancement Support System [CHESS]-Only) that gave caregivers access to CHESS, an online support system, and an experimental group (CHESS+CR [Clinician Report]), which also had CHESS but with a CR that automatically alerted clinicians if symptoms exceeded a predetermined threshold of severity. Participants were dyads (n=235) of patients with advanced lung, breast, or prostate cancer and their respective family caregivers from 5 oncology clinics in the United States of America. The proportion of improved patient threshold symptoms was compared between groups using area-under-the-curve analysis and binomial proportion tests. The proportion of threshold symptoms out of all reported symptoms was also examined. Results: When severe caregiver-reported symptoms were shared with clinicians, the symptoms were more likely to be subsequently reported as improved than when the symptoms were not shared with clinicians (P<.001). Fewer symptom reports were completed in the group of caregivers whose reports went to clinicians than in the CHESS-Only group (P<.001), perhaps because caregivers, knowing their reports might be sent to a doctor, feared they might be bothering the clinician. Conclusions: This study suggests that an eHealth system designed for caregivers that alerts clinicians to worrisome changes in patient health status may lead to reduced patient distress. Trial Registration: Clinicaltrials.gov NCT00214162; https://clinicaltrials.gov/ct2/show/NCT00214162 (Archived by WebCite at http://www.webcitation.org/6nmgdGfuD) and Clinicaltrials.gov NCT00365963; https://clinicaltrials.gov/ct2/show/NCT00365963 (Archived by WebCite at http://www.webcitation.org/6nmh0U8VP) %M 29138131 %R 10.2196/jmir.7466 %U http://www.jmir.org/2017/11/e354/ %U https://doi.org/10.2196/jmir.7466 %U http://www.ncbi.nlm.nih.gov/pubmed/29138131 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 11 %P e390 %T Effectiveness of a Web 2.0 Intervention to Increase Physical Activity in Real-World Settings: Randomized Ecological Trial %A Vandelanotte,Corneel %A Kolt,Gregory S %A Caperchione,Cristina M %A Savage,Trevor N %A Rosenkranz,Richard R %A Maeder,Anthony J %A Van Itallie,Anetta %A Tague,Rhys %A Oldmeadow,Christopher %A Mummery,W Kerry %A Duncan,Mitch J %+ Central Queensland University, Bruce Highway, Rockhampton, 4700, Australia, 61 749232183, c.vandelanotte@cqu.edu.au %K Internet %K online %K Web based %K behavioral intervention %K external validity %K pragmatic trial %D 2017 %7 13.11.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: The translation of Web-based physical activity intervention research into the real world is lacking and becoming increasingly important. Objective: To compare usage and effectiveness, in real-world settings, of a traditional Web 1.0 Web-based physical activity intervention, providing limited interactivity, to a Web 2.0 Web-based physical activity intervention that includes interactive features, such as social networking (ie, status updates, online “friends,” and personalized profile pages), blogs, and Google Maps mash-ups. Methods: Adults spontaneously signing up for the freely available 10,000 Steps website were randomized to the 10,000 Steps website (Web 1.0) or the newly developed WALK 2.0 website (Web 2.0). Physical activity (Active Australia Survey), quality of life (RAND 36), and body mass index (BMI) were assessed at baseline, 3 months, and 12 months. Website usage was measured continuously. Analyses of covariance were used to assess change over time in continuous outcome measures. Multiple imputation was used to deal with missing data. Results: A total of 1328 participants completed baseline assessments. Only 3-month outcomes (224 completers) were analyzed due to high attrition at 12 months (77 completers). Web 2.0 group participants increased physical activity by 92.8 minutes per week more than those in the Web 1.0 group (95% CI 28.8-156.8; P=.005); their BMI values also decreased more (–1.03 kg/m2, 95% CI –1.65 to -0.41; P=.001). For quality of life, only the physical functioning domain score significantly improved more in the Web 2.0 group (3.6, 95% CI 1.7-5.5; P<.001). The time between the first and last visit to the website (3.57 vs 2.22 weeks; P<.001) and the mean number of days the website was visited (9.02 vs 5.71 days; P=.002) were significantly greater in the Web 2.0 group compared to the Web 1.0 group. The difference in time-to-nonusage attrition was not statistically significant between groups (Hazard Ratio=0.97, 95% CI 0.86-1.09; P=.59). Only 21.99% (292/1328) of participants (n=292 summed for both groups) were still using either website after 2 weeks and 6.55% (87/1328) were using either website after 10 weeks. Conclusions: The website that provided more interactive and social features was more effective in improving physical activity in real-world conditions. While the Web 2.0 website was visited significantly more, both groups nevertheless displayed high nonusage attrition and low intervention engagement. More research is needed to examine the external validity and generalizability of Web-based physical activity interventions. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12611000253909; https://anzctr.org.au /Trial/Registration/TrialReview.aspx?id=336588&isReview=true (Archived by WebCite at http://www.webcitation.org/6ufzw 2HxD) %M 29133282 %R 10.2196/jmir.8484 %U http://www.jmir.org/2017/11/e390/ %U https://doi.org/10.2196/jmir.8484 %U http://www.ncbi.nlm.nih.gov/pubmed/29133282 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 11 %P e385 %T Tailored Web-Based Interventions for Pain: Systematic Review and Meta-Analysis %A Martorella,Geraldine %A Boitor,Madalina %A Berube,Melanie %A Fredericks,Suzanne %A Le May,Sylvie %A Gélinas,Céline %+ College of Nursing, Florida State University, Vivian M Duxbury Hall, 98 Varsity Way, Tallahassee, FL, 32306, United States, 1 850 644 6028, gmartorella@fsu.edu %K Web-based intervention %K tailored intervention %K pain management %K chronic pain %K acute pain %K review %K systematic review %K meta-analysis %D 2017 %7 10.11.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Efforts have multiplied in the past decade to underline the importance of pain management. For both acute and chronic pain management, various barriers generate considerable treatment accessibility issues, thereby providing an opportunity for alternative intervention formats to be implemented. Several systematic reviews on Web-based interventions with a large emphasis on chronic pain and cognitive behavioral therapy have been recently conducted to explore the influence of these interventions on pain management However, to our knowledge, the specific contribution of tailored Web-based interventions for pain management has not been described and their effect on pain has not been evaluated. Objective: The primary aim of this systematic review was to answer the following research question: What is the effect of tailored Web-based pain management interventions for adults on pain intensity compared with usual care, face-to-face interventions, and standardized Web-based interventions? A secondary aim was to examine the effects of these interventions on physical and psychological functions. Methods: We conducted a systematic review of articles published from January 2000 to December 2015. We used the DerSimonian-Laird random effects models with 95% confidence intervals to calculate effect estimates for all analyses. We calculated standardized mean differences from extracted means and standard deviations, as outcome variables were measured on different continuous scales. We evaluated 5 different outcomes: pain intensity (primary outcome), pain-related disability, anxiety, depression, and pain catastrophizing. We assessed effects according to 3 time intervals: short term (<1 month), medium term (1-6 months), and long term (6-12 months). Results: After full-text review, we excluded 31 articles, resulting in 17 eligible studies. Only 1 study concerned acute pain and was removed from the meta-analysis, resulting in 16 studies available for quantitative assessment. Compared with standard care or a waiting list, tailored Web-based intervention showed benefits immediately after, with small effect sizes (<0.40) for pain intensity (10 randomized controlled trials [RCTs], n=1310, P=.003) and pain-related disability (6 RCTs, n=953, P<.001). No other improvements were observed at follow-up in the medium and long terms. Compared with the active control group, no improvements were found for the primary outcome (pain intensity) or any of the outcomes except for a small effect size on pain catastrophizing (2 RCTs, n=333, P<.001) immediately after the intervention. Conclusions: Tailored Web-based interventions did not prove to be more efficacious than standardized Web-based interventions in terms of pain intensity, pain-related disability, anxiety, and depression. An interesting finding was that some efficacy was shown on pain catastrophizing compared with active control interventions. Considering the diversity of approaches used in tailored Web-based interventions for chronic pain management, their efficacy is yet to be explored. Moreover, their contribution to acute pain management is embryonic. Trial Registration: International prospective register of systematic reviews (PROSPERO): CRD42015027669; http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42015027669 (Archived by WebCite at http://www. webcitation.org/6uneWAuyR) %M 29127076 %R 10.2196/jmir.8826 %U http://www.jmir.org/2017/11/e385/ %U https://doi.org/10.2196/jmir.8826 %U http://www.ncbi.nlm.nih.gov/pubmed/29127076 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 11 %P e384 %T Brain Activation in Response to Personalized Behavioral and Physiological Feedback From Self-Monitoring Technology: Pilot Study %A Whelan,Maxine E %A Morgan,Paul S %A Sherar,Lauren B %A Kingsnorth,Andrew P %A Magistro,Daniele %A Esliger,Dale W %+ Loughborough University, School of Sport, Exercise and Health Sciences, Epinal Way, Loughborough,, United Kingdom, 44 1509226302, m.e.whelan@lboro.ac.uk %K functional magnetic resonance imaging %K neuroimaging %K physical activity %K sedentary behavior %K interstitial glucose %D 2017 %7 08.11.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: The recent surge in commercially available wearable technology has allowed real-time self-monitoring of behavior (eg, physical activity) and physiology (eg, glucose levels). However, there is limited neuroimaging work (ie, functional magnetic resonance imaging [fMRI]) to identify how people’s brains respond to receiving this personalized health feedback and how this impacts subsequent behavior. Objective: Identify regions of the brain activated and examine associations between activation and behavior. Methods: This was a pilot study to assess physical activity, sedentary time, and glucose levels over 14 days in 33 adults (aged 30 to 60 years). Extracted accelerometry, inclinometry, and interstitial glucose data informed the construction of personalized feedback messages (eg, average number of steps per day). These messages were subsequently presented visually to participants during fMRI. Participant physical activity levels and sedentary time were assessed again for 8 days following exposure to this personalized feedback. Results: Independent tests identified significant activations within the prefrontal cortex in response to glucose feedback compared with behavioral feedback (P<.001). Reductions in mean sedentary time (589.0 vs 560.0 minutes per day, P=.014) were observed. Activation in the subgyral area had a moderate correlation with minutes of moderate-to-vigorous physical activity (r=0.392, P=.043). Conclusion: Presenting personalized glucose feedback resulted in significantly more brain activation when compared with behavior. Participants reduced time spent sedentary at follow-up. Research on deploying behavioral and physiological feedback warrants further investigation. %M 29117928 %R 10.2196/jmir.8890 %U http://www.jmir.org/2017/11/e384/ %U https://doi.org/10.2196/jmir.8890 %U http://www.ncbi.nlm.nih.gov/pubmed/29117928 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 11 %P e360 %T A Fully Automated Web-Based Program Improves Lifestyle Habits and HbA1c in Patients With Type 2 Diabetes and Abdominal Obesity: Randomized Trial of Patient E-Coaching Nutritional Support (The ANODE Study) %A Hansel,Boris %A Giral,Philippe %A Gambotti,Laetitia %A Lafourcade,Alexandre %A Peres,Gilbert %A Filipecki,Claude %A Kadouch,Diana %A Hartemann,Agnes %A Oppert,Jean-Michel %A Bruckert,Eric %A Marre,Michel %A Bruneel,Arnaud %A Duchene,Emilie %A Roussel,Ronan %+ Hôpitaux Universitaires Paris-Nord Val de Seine, Department of Endocrinology, Diabetology, Nutrition, Assistance Publique-Hôpitaux de Paris, 46 Rue Henri Huchard, Paris, 75018, France, 33 0611307469, boris.hansel@aphp.fr %K e-health %K nutrition %K type 2 diabetes %D 2017 %7 08.11.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: The prevalence of abdominal obesity and type 2 diabetes mellitus (T2DM) is a public health challenge. New solutions need to be developed to help patients implement lifestyle changes. Objective: The objective of the study was to evaluate a fully automated Web-based intervention designed to help users improve their dietary habits and increase their physical activity. Methods: The Accompagnement Nutritionnel de l’Obésité et du Diabète par E-coaching (ANODE) study was a 16-week, 1:1 parallel-arm, open-label randomized clinical trial. Patients with T2DM and abdominal obesity (n=120, aged 18-75 years) were recruited. Patients in the intervention arm (n=60) had access to a fully automated program (ANODE) to improve their lifestyle. Patients were asked to log on at least once per week. Human contact was limited to hotline support in cases of technical issues. The dietetic tool provided personalized menus and a shopping list for the day or the week. Stepwise physical activity was prescribed. The control arm (n=60) received general nutritional advice. The primary outcome was the change of the dietary score (International Diet Quality Index; DQI-I) between baseline and the end of the study. Secondary endpoints included changes in body weight, waist circumference, hemoglobin A1c (HbA1c) and measured maximum oxygen consumption (VO2 max). Results: The mean age of the participants was 57 years (standard deviation [SD] 9), mean body mass index was 33 kg/m² (SD 4), mean HbA1c was 7.2% (SD 1.1), and 66.7% (80/120) of participants were women. Using an intention-to-treat analysis, the DQI-I score (54.0, SD 5.7 in the ANODE arm; 52.8, SD 6.2 in the control arm; P=.28) increased significantly in the ANODE arm compared to the control arm (+4.55, SD 5.91 vs -1.68, SD 5.18; between arms P<.001). Body weight, waist circumference, and HbA1c changes improved significantly in the intervention. Conclusions: Among patients with T2DM and abdominal obesity, the use of a fully automated Web-based program resulted in a significant improvement in dietary habits and favorable clinical and laboratory changes. The sustainability of these effects remains to be determined. Trial Registration: ClinicalTrials.gov NCT02343107; http://clinicaltrials.gov/ct2/show/NCT02343107 (Archived by WebCite at http://www.webcitation.org/6uVMKPRzs) %M 29117929 %R 10.2196/jmir.7947 %U http://www.jmir.org/2017/11/e360/ %U https://doi.org/10.2196/jmir.7947 %U http://www.ncbi.nlm.nih.gov/pubmed/29117929 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 11 %P e379 %T Sexual Health and the Internet: Cross-Sectional Study of Online Preferences Among Adolescents %A von Rosen,Antonella Juline %A von Rosen,Frederik Tilmann %A Tinnemann,Peter %A Müller-Riemenschneider,Falk %+ Institute for Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, Luisenstr 57, Berlin, 10117, Germany, 49 15208804891, an_pa@uni-bremen.de %K adolescent %K adolescent behavior %K Internet %K reproductive health %K health literacy %K sex education %K cross-sectional studies %K online preferences %K eHealth literacy %D 2017 %7 08.11.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: The Internet is widely used by adolescents for sexual health information and bears the potential to increase knowledge and positively affect behavior. Objective: The objective of this study is to assess students’ preferences when looking for sexual health information online. Methods: We conducted a cross-sectional survey among ninth grade students in a convenience sample of 13 secondary schools in Berlin, Germany. During a regular school period, participants were requested to rate the importance they attribute to nine aspects of sexual health websites in a paper-based questionnaire. Bivariate and multivariable analyses were used to assess awareness and preferences by gender, age, migrant background, and school type. Results: Of 1190 eligible students, 1177 (98.91%) students with a mean age of 14.6 (SD 0.7) years participated, 52.52% (605/1152) were male, and 52.94% (612/1156) had at least one parent born abroad. Participant numbers were spread equally across three types of secondary schools in Berlin. Website aspects most frequently cited as important were easily comprehensible wording (88.33%, 961/1088), clear information layout (80.57%, 871/1081), and reliability of the website’s publisher (79.28%, 857/1081), whereas the visual style of a website was deemed important by the lowest number of students (35.13%, 378/1076). There was a marked gender difference in the importance students attached to website publisher reliability. Although 437/515 (84.9%) of female participants regarded this as important, only 420/566 (74.2%) of male participants did likewise (P<.001). In multivariable analyses, demographic differences were also particularly visible in the importance of publisher reliability: male participants were significantly less likely to find this aspect important (OR 0.50, 95% CI 0.37-0.69). The odds ratio for students with migrant background was 0.64 (95% CI 0.50-0.81, reference=no migrant background) and OR 2.04 (95% CI 1.03-4.03) for students in the most academic school type (reference=least academic). Conclusions: Students prefer easily understandable online resources. Setting up sexual health websites according to the explicit preferences of the target audience might encourage usage, especially by those subpopulations less likely to critically assess information validity: male adolescents, children of immigrants, and the academically disadvantaged. %M 29117927 %R 10.2196/jmir.7068 %U http://www.jmir.org/2017/11/e379/ %U https://doi.org/10.2196/jmir.7068 %U http://www.ncbi.nlm.nih.gov/pubmed/29117927 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 11 %P e369 %T Preventing Depression in Final Year Secondary Students: School-Based Randomized Controlled Trial %A Perry,Yael %A Werner-Seidler,Aliza %A Calear,Alison %A Mackinnon,Andrew %A King,Catherine %A Scott,Jan %A Merry,Sally %A Fleming,Theresa %A Stasiak,Karolina %A Christensen,Helen %A Batterham,Philip J %+ Black Dog Institute, University of New South Wales, Hospital Road, Randwick,, Australia, 61 2 9382 8208, h.christensen@blackdog.org.au %K prevention %K depression %K adolescent %K digital cognitive behavior therapy %D 2017 %7 02.11.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression often emerges for the first time during adolescence. There is accumulating evidence that universal depression prevention programs may have the capacity to reduce the impact of depression when delivered in the school environment. Objective: This trial investigated the effectiveness of SPARX-R, a gamified online cognitive behavior therapy intervention for the prevention of depression relative to an attention-matched control intervention delivered to students prior to facing a significant stressor—final secondary school exams. It was hypothesized that delivering a prevention intervention in advance of a stressor would reduce depressive symptoms relative to the control group. Methods: A cluster randomized controlled trial was conducted in 10 government schools in Sydney, Australia. Participants were 540 final year secondary students (mean 16.7 [SD 0.51] years), and clusters at the school level were randomly allocated to SPARX-R or the control intervention. Interventions were delivered weekly in 7 modules, each taking approximately 20 to 30 minutes to complete. The primary outcome was symptoms of depression as measured by the Major Depression Inventory. Intention-to-treat analyses were performed. Results: Compared to controls, participants in the SPARX-R condition (n=242) showed significantly reduced depression symptoms relative to the control (n=298) at post-intervention (Cohen d=0.29) and 6 months post-baseline (d=0.21) but not at 18 months post-baseline (d=0.33). Conclusions: This is the first trial to demonstrate a preventive effect on depressive symptoms prior to a significant and universal stressor in adolescents. It demonstrates that an online intervention delivered in advance of a stressful experience can reduce the impact of such an event on the potential development or exacerbation of depression. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12614000316606; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365986 (Archived by WebCite at http://www.webcitation.org/ 6u7ou1aI9) %M 29097357 %R 10.2196/jmir.8241 %U http://www.jmir.org/2017/11/e369/ %U https://doi.org/10.2196/jmir.8241 %U http://www.ncbi.nlm.nih.gov/pubmed/29097357 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 11 %P e356 %T Engagement Within a Mobile Phone–Based Smoking Cessation Intervention for Adolescents and its Association With Participant Characteristics and Outcomes %A Paz Castro,Raquel %A Haug,Severin %A Filler,Andreas %A Kowatsch,Tobias %A Schaub,Michael P %+ Swiss Research Institute for Public Health and Addiction, Zurich University, Konradstrasse 32, Zurich, 8031, Switzerland, 41 444481180, raquel.paz@isgf.uzh.ch %K tobacco %K alcohol drinking %K adolescent %K mobile phones %K treatment outcome %D 2017 %7 01.11.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Although mobile phone–delivered smoking cessation programs are a promising way to promote smoking cessation among adolescents, little is known about how adolescents might actually use them. Objective: The aim of this study was to determine adolescents’ trajectories of engagement with a mobile phone–delivered smoking cessation program over time and the associations these trajectories have with baseline characteristics and treatment outcomes. Methods: We performed secondary data analysis on a dataset from a study that compared a mobile phone–delivered integrated smoking cessation and alcohol intervention with a smoking cessation only intervention for adolescents recruited in vocational and upper secondary school classes (N=1418). Throughout the 3-month intervention, participants in both intervention groups received one text message prompt per week that either assessed smoking-related target behaviors or encouraged participation in a quiz or a message contest. Sequence analyses were performed to identify engagement trajectories. Analyses were conducted to identify predictors of engagement trajectory and associations between engagement trajectories and treatment outcomes. Results: Three engagement trajectories emerged: (1) stable engagement (646/1418, 45.56%), (2) decreasing engagement (501/1418, 35.33%), and (3) stable nonengagement (271/1418, 19.11%). Adolescents who were younger, had no immigrant background, perceived more benefits of quitting smoking, and reported binge drinking preceding the baseline assessment were more likely to exhibit stable engagement. Due to different reach of more engaged and less engaged participants at follow-up, three statistical models (complete-cases, last-observation-carried-forward, and multiple imputation) for the associations of engagement trajectory and smoking outcome were tested. For 7-point smoking abstinence, no association was revealed to be statistically significant over all three models. However, decreasing engagement with the program was associated over all three models, with greater reductions in daily tobacco use than nonengagement. Conclusions: The majority of tobacco-smoking adolescents engaged extensively with a mobile phone–based smoking cessation program. However, not only stable engagement but also decreasing engagement with a program might be an indicator of behavioral change. Measures to avoid nonengagement among adolescents appear especially necessary for older smokers with an immigrant background who do not drink excessively. In addition, future studies should not only examine the use of specific program components but also users’ engagement trajectories to better understand the mechanisms behind behavioral change. %M 29092811 %R 10.2196/jmir.7928 %U http://www.jmir.org/2017/11/e356/ %U https://doi.org/10.2196/jmir.7928 %U http://www.ncbi.nlm.nih.gov/pubmed/29092811 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 3 %N 2 %P e17 %T “Thanks for Letting Us All Share Your Mammogram Experience Virtually”: Developing a Web-Based Hub for Breast Cancer Screening %A Galpin,Adam %A Meredith,Joanne %A Ure,Cathy %A Robinson,Leslie %+ Directorate of Psychology and Public Health, School of Health Sciences, University of Salford, The Crescent, Salford, M6 6PU, United Kingdom, 44 161 2957146 ext 57146, A.J.Galpin@Salford.ac.uk %K decision making %K eHealth %K cancer screening %K qualitative research %K social media %K mammography %D 2017 %7 27.10.2017 %9 Original Paper %J JMIR Cancer %G English %X Background: The decision around whether to attend breast cancer screening can often involve making sense of confusing and contradictory information on its risks and benefits. The Word of Mouth Mammogram e-Network (WoMMeN) project was established to create a Web-based resource to support decision making regarding breast cancer screening. This paper presents data from our user-centered approach in engaging stakeholders (both health professionals and service users) in the design of this Web-based resource. Our novel approach involved creating a user design group within Facebook to allow them access to ongoing discussion between researchers, radiographers, and existing and potential service users. Objective: This study had two objectives. The first was to examine the utility of an online user design group for generating insight for the creation of Web-based health resources. We sought to explore the advantages and limitations of this approach. The second objective was to analyze what women want from a Web-based resource for breast cancer screening. Methods: We recruited a user design group on Facebook and conducted a survey within the group, asking questions about design considerations for a Web-based breast cancer screening hub. Although the membership of the Facebook group varied over time, there were 71 members in the Facebook group at the end point of analysis. We next conducted a framework analysis on 70 threads from Facebook and a thematic analysis on the 23 survey responses. We focused additionally on how the themes were discussed by the different stakeholders within the context of the design group. Results: Two major themes were found across both the Facebook discussion and the survey data: (1) the power of information and (2) the hub as a place for communication and support. Information was considered as empowering but also recognized as threatening. Communication and the sharing of experiences were deemed important, but there was also recognition of potential miscommunication within online discussion. Health professionals and service users expressed the same broad concerns, but there were subtle differences in their opinions. Importantly, the themes were triangulated between the Facebook discussions and the survey data, supporting the validity of an online user design group. Conclusions: Online user design groups afford a useful method for understanding stakeholder needs. In contrast to focus groups, they afford access to users from diverse geographical locations and traverse time constraints, allowing more follow-ups to responses. The use of Facebook provides a familiar and naturalistic setting for discussion. Although we acknowledge the limitations in the sample, this approach has allowed us to understand the views of stakeholders in the user-centered design of the WoMMeN hub for breast cancer screening. %M 29079555 %R 10.2196/cancer.8150 %U http://cancer.jmir.org/2017/2/e17/ %U https://doi.org/10.2196/cancer.8150 %U http://www.ncbi.nlm.nih.gov/pubmed/29079555 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 10 %P e207 %T Internet-Delivered Dialectical Behavioral Therapy Skills Training for Suicidal and Heavy Episodic Drinkers: Protocol and Preliminary Results of a Randomized Controlled Trial %A Wilks,Chelsey %A Yin,Qingqing %A Ang,Sin Yee %A Matsumiya,Brandon %A Lungu,Anita %A Linehan,Marsha %+ Behavioral Research and Therapy Clinics, Department of Psychology, University of Washington, 3935 University Way, Seattle, WA, 98195, United States, 1 7027156241, wilksc@u.washington.edu %K dialectical behavioral therapy %K randomized controlled trial %K eMental health %K suicide %K heavy episodic drinking %K emotion dysregulation %D 2017 %7 25.10.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: The need to develop effective and accessible interventions for suicidal individuals engaging in heavy episodic drinking (HED) cannot be understated. While the link between alcohol use and suicidality is a complex one that remains to be elucidated, emotion dysregulation may play a key role in alcohol-related suicide risk in these individuals. Objective: In the current study, an 8-week Internet-delivered dialectical behavior therapy (DBT) skills training intervention was developed and preliminarily evaluated for suicidal individuals who engage in HED to regulate emotions. The aim of the study is to evaluate the feasibility and effectiveness of the therapist-assisted and Internet-delivered intervention, and to inform the design of a subsequent full-scale study. Methods: The study was a pilot randomized controlled trial comparing participants receiving immediate-treatment (n=30) to waitlist controls (n=29) over a period of 16 weeks. Intervention effects will be assessed longitudinally using hierarchical linear modeling and generalized estimating equations, along with analyses of effect sizes and clinically significant change. The primary outcomes are suicidal ideation, alcohol problems, and emotion dysregulation. Secondary outcomes include alcohol-related consequences, reasons for living, skills use, and depression. Results: The trial is ongoing. A total of 60 individuals returned their informed consent and were randomized, of whom 59 individuals were intended to treat. A total of 50 participants in the study were retained through the 16-week enrollment. Conclusions: There is a dearth of evidence-based treatment for individuals presenting with high risk and complex behaviors. Furthermore, computerized interventions may provide a beneficial alternative to traditional therapies. The particular clinical features and treatment needs of suicidal individuals who also engage in HED constitute key domains for further investigation that are needed to consolidate the design of appropriate interventions for this high-risk population. Trial Registration: Clinicaltrials.gov NCT02932241; https://clinicaltrials.gov/ct2/show/NCT02932241 (Archived by WebCite at http://www.webcitation.org/6uJHdQsC2) %M 29070480 %R 10.2196/resprot.7767 %U http://www.researchprotocols.org/2017/10/e207/ %U https://doi.org/10.2196/resprot.7767 %U http://www.ncbi.nlm.nih.gov/pubmed/29070480 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 10 %P e357 %T Social Media–Promoted Weight Loss Among an Occupational Population: Cohort Study Using a WeChat Mobile Phone App-Based Campaign %A He,Chao %A Wu,Shiyan %A Zhao,Yingying %A Li,Zheng %A Zhang,Yanyan %A Le,Jia %A Wang,Lei %A Wan,Siyang %A Li,Changqing %A Li,Yindong %A Sun,Xinying %+ Department of Social Medicine and Health Education, School of Public Health, Peking University Health Science Center, No.38, Xueyuan Road Haidian District Beijing 100191, P.R.China, Beijing, 100191, China, 86 13691212050, xysun@bjmu.edu.cn %K WeChat %K weight loss %K social media %K health %K intervention %D 2017 %7 23.10.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Being overweight and obese are major risk factors for noncommunicable diseases such as cardiovascular diseases. The prevalence of overweight and obesity is high throughout the world and these issues are very serious in the Shunyi District in China. As mobile technologies have rapidly developed, mobile apps such as WeChat are well accepted and have the potential to improve health behaviors. Objective: This study aims to evaluate the effectiveness of a mobile app (WeChat) as an intervention on weight loss behavior. Methods: This study was conducted among an occupational population from August 2015 to February 2016 in the Shunyi District of Beijing. Before the intervention, the Shunyi District Government released an official document for weight loss to all 134 government agencies and enterprises in Shunyi District. Participants willing to use our official WeChat account were enrolled in a WeChat group and received 6 months of interventions for weight loss; those who were not willing to use the account were in a control group given routine publicity on weight loss. Results: In total, 15,310 occupational participants including 3467 participants (22.65%) in the control group and 11,843 participants (77.35%) in the WeChat group were enrolled. Participants in the WeChat group lost more weight (mean 2.09, SD 3.43 kg) than people in the control group (mean 1.78, SD 2.96 kg), and the difference in mean weight loss between the two groups for males was significant based on the stratification of age and educational level. To control for confounding factors and to explore the effects of WeChat on weight loss, the propensity score method with a multinominal logistic regression was utilized. For males, this showed that the WeChat group (with both active and inactive subgroups) had a higher probability of maintaining weight, weight loss from 1 to 2 kg, or weight loss more than 2 kg than the control group. However, the control group had higher probability of weight loss from 0 to 1 kg. Being active in WeChat was likely to be associated with weight loss. The more active participants were in the weight loss program via WeChat, the more weight they lost. Conclusions: The weight loss intervention campaign based on an official WeChat account focused on an occupation-based population in Shunyi District was effective for males. The more active male participants were in using WeChat, the more weight they lost. There might be no effect or there may even be a negative effect on weight loss for females. Future research should focus on how to improve adherence to the WeChat weight loss interventions, to improve and refine the WeChat content such as developing a variety of materials to attract interest, and to protect personal privacy, especially for females. %M 29061555 %R 10.2196/jmir.7861 %U http://www.jmir.org/2017/10/e357/ %U https://doi.org/10.2196/jmir.7861 %U http://www.ncbi.nlm.nih.gov/pubmed/29061555 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 10 %P e350 %T Experiences From a Web- and App-Based Workplace Health Promotion Intervention Among Employees in the Social and Health Care Sector Based on Use-Data and Qualitative Interviews %A Balk-Møller,Nina Charlotte %A Larsen,Thomas Meinert %A Holm,Lotte %+ Department of Nutrition, Exercise and Sports, University of Copenhagen, Rolighedsvej 26, Frederiksberg C, 1958, Denmark, 45 27126320, nbm@nexs.ku.dk %K eHealth %K health promotion %K workplace %K smartphone %K weight reduction programs %K Internet %K qualitative research %D 2017 %7 19.10.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: An increasing number of Web- and app-based tools for health promotion are being developed at the moment. The ambition is generally to reach out to a larger part of the population and to help users improve their lifestyle and develop healthier habits, and thereby improve their health status. However, the positive effects are generally modest. To understand why the effects are modest, further investigation into the participants’ experiences and the social aspects of using Web- and app-based health promotion tools is needed. Objective: The objectives of this study were to investigate the motivation behind taking part in and using a Web- and app-based health promotion tool (SoSu-life) at the workplace and to explore the participants’ experiences with using the tool. Methods: Qualitative interviews with 26 participants who participated in a 38-week randomized controlled trial of a workplace Web- and app-based tool for health promotion were conducted. Data were supplemented with tracking the frequency of use. The basic features of the tool investigated in the trial were self-reporting of diet and exercise, personalized feedback, suggestions for activities and programs, practical tips and tricks, and a series of social features designed to support and build interactions among the participants at the workplace. Results: The respondents reported typically one of the two reasons for signing up to participate in the study: either a personal wish to attain some health benefits or the more social reason that participants did not want to miss out on the social interaction with colleagues. Peer pressure from colleagues had made some participants to sign up even though they did not believe they had an unhealthy behavior. Of the total of 355 participants in the intervention group, 203 (57.2%) left the intervention before it ended. Of the remaining participants, most did not use the tool after the competition at the end of the initial 16-week period. The actual number of active users of the tool throughout the whole intervention period was low; however, the participants reported that lifestyle habits became a topic of conversation. Conclusions: A tool that addresses group interactions at workplaces appears to initiate peer pressure, which helped recruitment for participation. However, active participation was low. A social change was indicated, allowing for more interaction among colleagues around healthy lifestyle issues. Future and more long-term studies are needed to determine whether such social changes could lead to sustained improvements of health. %M 29051133 %R 10.2196/jmir.7278 %U http://www.jmir.org/2017/10/e350/ %U https://doi.org/10.2196/jmir.7278 %U http://www.ncbi.nlm.nih.gov/pubmed/29051133 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 10 %P e336 %T Effectiveness of Two Web-Based Interventions for Chronic Cancer-Related Fatigue Compared to an Active Control Condition: Results of the “Fitter na kanker” Randomized Controlled Trial %A Bruggeman-Everts,Fieke Z %A Wolvers,Marije D J %A van de Schoot,Rens %A Vollenbroek-Hutten,Miriam M R %A Van der Lee,Marije L %+ Helen Dowling Instituut, Scientific Research Department, Professor Bronkhorstlaan 20, Bilthoven, 3723 MB, Netherlands, 31 30 252 40 20, bruggeman.everts@gmail.com %K fatigue %K cancer survivors %K Internet interventions %K mindfulness-based cognitive therapy %K physiotherapy %K accelerometry %K latent growth analysis %K implementation %K RCT %D 2017 %7 19.10.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Approximately one third of all patients who have been successfully treated for cancer suffer from chronic cancer-related fatigue (CCRF). Effective and easily accessible interventions are needed for these patients. Objective: The current paper reports on the results of a 3-armed randomized controlled trial investigating the clinical effectiveness of two different guided Web-based interventions for reducing CCRF compared to an active control condition. Methods: Severely fatigued cancer survivors were recruited via online and offline channels, and self-registered on an open-access website. After eligibility checks, 167 participants were randomized via an embedded automated randomization function into: (1) physiotherapist-guided Ambulant Activity Feedback (AAF) therapy encompassing the use of an accelerometer (n=62); (2) psychologist-guided Web-based mindfulness-based cognitive therapy (eMBCT; n=55); or (3) an unguided active control condition receiving psycho-educational emails (n=50). All interventions lasted nine weeks. Fatigue severity was self-assessed using the Checklist Individual Strength - Fatigue Severity subscale (primary outcome) six times from baseline (T0b) to six months (T2). Mental health was self-assessed three times using the Hospital Anxiety and Depression Scale and Positive and Negative Affect Schedule (secondary outcome). Treatment dropout was investigated. Results: Multiple group latent growth curve analysis, corrected for individual time between assessments, showed that fatigue severity decreased significantly more in the AAF and eMBCT groups compared to the psycho-educational group. The analyses were checked by a researcher who was blind to allocation. Clinically relevant changes in fatigue severity were observed in 66% (41/62) of patients in AAF, 49% (27/55) of patients in eMBCT, and 12% (6/50) of patients in psycho-education. Dropout was 18% (11/62) in AAF, mainly due to technical problems and poor usability of the accelerometer, and 38% (21/55) in eMBCT, mainly due to the perceived high intensity of the program. Conclusions: Both the AAF and eMBCT interventions are effective for managing fatigue severity compared to receiving psycho-educational emails. Trial Registration: Trialregister.nl NTR3483; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3483 (Archived by WebCite at http://www.webcitation.org/6NWZqon3o) %M 29051138 %R 10.2196/jmir.7180 %U http://www.jmir.org/2017/10/e336/ %U https://doi.org/10.2196/jmir.7180 %U http://www.ncbi.nlm.nih.gov/pubmed/29051138 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 10 %P e351 %T Factors Associated With Engagement With a Web-Based Lifestyle Intervention Following Provision of Coronary Heart Disease Risk: Mixed Methods Study %A Usher-Smith,Juliet A %A Winther,Laura R %A Shefer,Guy S %A Silarova,Barbora %A Payne,Rupert A %A Griffin,Simon J %+ The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Institute of Public Health, Box 113 Cambridge Biomedical Campus, Cambridge, CB2 0SR, United Kingdom, 44 1223748693, jau20@medschl.cam.ac.uk %K Web-based intervention %K cardiovascular disease %K engagement %K risk %K qualitative research %D 2017 %7 16.10.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based interventions provide the opportunity to combine the tailored approach of face-to-face interventions with the scalability and cost-effectiveness of public health interventions. This potential is often limited by low engagement. A number of studies have described the characteristics of individuals who engage more in Web-based interventions but few have explored the reasons for these variations. Objective: We aimed to explore individual-level factors associated with different degrees of engagement with a Web-based behavior change intervention following provision of coronary heart disease (CHD) risk information, and the barriers and facilitators to engagement. Methods: This study involved the secondary analysis of data from the Information and Risk Modification Trial, a randomized controlled trial of a Web-based lifestyle intervention alone, or alongside information on estimated CHD risk. The intervention consisted of three interactive sessions, each lasting up to 60 minutes, delivered at monthly intervals. Participants were characterized as high engagers if they completed all three sessions. Thematic analysis of qualitative data from interviews with 37 participants was combined with quantitative data on usage of the Web-based intervention using a mixed-methods matrix, and data on the views of the intervention itself were analyzed across all participants. Results: Thirteen participants were characterized as low engagers and 24 as high engagers. There was no difference in age (P=.75), gender (P=.95), or level of risk (P=.65) between the groups. Low engagement was more often associated with: (1) reporting a negative emotional reaction in response to the risk score (P=.029), (2) perceiving that the intervention did not provide any new lifestyle information (P=.011), and (3) being less likely to have reported feeling an obligation to complete the intervention as part of the study (P=.019). The mixed-methods matrix suggested that there was also an association between low engagement and less success with previous behavior change attempts, but the statistical evidence for this association was weak (P=.16). No associations were seen between engagement and barriers or facilitators to health behavior change, or comments about the design of the intervention itself. The most commonly cited barriers related to issues with access to the intervention itself: either difficulties remembering the link to the site or passwords, a perceived lack of flexibility within the website, or lack of time. Facilitators included the nonjudgmental presentation of lifestyle information, the use of simple language, and the personalized nature of the intervention. Conclusions: This study shows that the level of engagement with a Web-based intervention following provision of CHD risk information is not influenced by the level of risk but by the individual’s response to the risk information, their past experiences of behavior change, the extent to which they consider the lifestyle information helpful, and whether they felt obliged to complete the intervention as part of a research study. A number of facilitators and barriers to Web-based interventions were also identified, which should inform future interventions. %M 29038095 %R 10.2196/jmir.7697 %U http://www.jmir.org/2017/10/e351/ %U https://doi.org/10.2196/jmir.7697 %U http://www.ncbi.nlm.nih.gov/pubmed/29038095 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 10 %P e334 %T Effect of a Website That Presents Patients’ Experiences on Self-Efficacy and Patient Competence of Colorectal Cancer Patients: Web-Based Randomized Controlled Trial %A Giesler,Jürgen M %A Keller,Bettina %A Repke,Tim %A Leonhart,Rainer %A Weis,Joachim %A Muckelbauer,Rebecca %A Rieckmann,Nina %A Müller-Nordhorn,Jacqueline %A Lucius-Hoene,Gabriele %A Holmberg,Christine %+ Institute of Public Health, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Seestr 73 - Haus 10, Berlin, 13347, Germany, 49 30450529192, christine.holmberg@charite.de %K self-efficacy %K colorectal cancer %K patient competence %K narrative information %K Web-based experiential information %D 2017 %7 13.10.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Patients often seek other patients’ experiences with the disease. The Internet provides a wide range of opportunities to share and learn about other people’s health and illness experiences via blogs or patient-initiated online discussion groups. There also exists a range of medical information devices that include experiential patient information. However, there are serious concerns about the use of such experiential information because narratives of others may be powerful and pervasive tools that may hinder informed decision making. The international research network DIPEx (Database of Individual Patients’ Experiences) aims to provide scientifically based online information on people’s experiences with health and illness to fulfill patients’ needs for experiential information, while ensuring that the presented information includes a wide variety of possible experiences. Objective: The aim is to evaluate the colorectal cancer module of the German DIPEx website krankheitserfahrungen.de with regard to self-efficacy for coping with cancer and patient competence. Methods: In 2015, a Web-based randomized controlled trial was conducted using a two-group between-subjects design and repeated measures. The study sample consisted of individuals who had been diagnosed with colorectal cancer within the past 3 years or who had metastasis or recurrent disease. Outcome measures included self-efficacy for coping with cancer and patient competence. Participants were randomly assigned to either an intervention group that had immediate access to the colorectal cancer module for 2 weeks or to a waiting list control group. Outcome criteria were measured at baseline before randomization and at 2 weeks and 6 weeks Results: The study randomized 212 persons. On average, participants were 54 (SD 11.1) years old, 58.8% (124/211) were female, and 73.6% (156/212) had read or heard stories of other patients online before entering the study, thus excluding any influence of the colorectal cancer module on krankheitserfahrungen.de. No intervention effects were found at 2 and 6 weeks after baseline. Conclusions: The results of this study do not support the hypothesis that the website studied may increase self-efficacy for coping with cancer or patient competencies such as self-regulation or managing emotional distress. Possible explanations may involve characteristics of the website itself, its use by participants, or methodological reasons. Future studies aimed at evaluating potential effects of websites providing patient experiences on the basis of methodological principles such as those of DIPEx might profit from extending the range of outcome measures, from including additional measures of website usage behavior and users’ motivation, and from expanding concepts, such as patient competency to include items that more directly reflect patients’ perceived effects of using such a website. Trial Registration: Clinicaltrials.gov NCT02157454; https://clinicaltrials.gov/ct2/show/NCT02157454 (Archived by WebCite at http://www.webcitation.org/6syrvwXxi) %M 29030329 %R 10.2196/jmir.7639 %U http://www.jmir.org/2017/10/e334/ %U https://doi.org/10.2196/jmir.7639 %U http://www.ncbi.nlm.nih.gov/pubmed/29030329 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 10 %P e348 %T Characterizing Active Ingredients of eHealth Interventions Targeting Persons With Poorly Controlled Type 2 Diabetes Mellitus Using the Behavior Change Techniques Taxonomy: Scoping Review %A Kebede,Mihiretu M %A Liedtke,Tatjana P %A Möllers,Tobias %A Pischke,Claudia R %+ Prevention and Evaluation, Leibniz Institute for Prevention Research and Epidemiology, BIPS, 2nd Fl., 30 Achterstrasse, Bremen,, Germany, 49 421 218 56 916, kebede@leibniz-bips.de %K type 2 diabetes %K telemedicine %K mobile health %K telehealth %K eHealth %K mHealth %D 2017 %7 12.10.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: The behavior change technique taxonomy v1 (BCTTv1; Michie and colleagues, 2013) is a comprehensive tool to characterize active ingredients of interventions and includes 93 labels that are hierarchically clustered into 16 hierarchical clusters. Objective: The aim of this study was to identify the active ingredients in electronic health (eHealth) interventions targeting patients with poorly controlled type 2 diabetes mellitus (T2DM) and relevant outcomes. Methods: We conducted a scoping review using the BCTTv1. Randomized controlled trials (RCTs), studies with or pre-post-test designs, and quasi-experimental studies examining efficacy and effectiveness of eHealth interventions for disease management or the promotion of relevant health behaviors were identified by searching PubMed, Web of Science, and PsycINFO. Reviewers independently screened titles and abstracts for eligibility using predetermined eligibility criteria. Data were extracted following a data extraction sheet. The BCTTv1 was used to characterize active ingredients of the interventions reported in the included studies. Results: Of the 1404 unique records screened, 32 studies fulfilled the inclusion criteria and reported results on the efficacy and or or effectiveness of interventions. Of the included 32 studies, 18 (56%) were Web-based interventions delivered via personal digital assistant (PDA), tablet, computer, and/or mobile phones; 7 (22%) were telehealth interventions delivered via landline; 6 (19%) made use of text messaging (short service message, SMS); and 1 employed videoconferencing (3%). Of the 16 hierarchical clusters of the BCTTv1, 11 were identified in interventions included in this review. Of the 93 individual behavior change techniques (BCTs), 31 were identified as active ingredients of the interventions. The most common BCTs identified were instruction on how to perform behavior, adding objects to the environment, information about health consequences, self-monitoring of the outcomes and/or and prefers to be explicit to avoid ambiguity. Response: Checked and avoided of a certain behavior Author: Please note that the journal discourages the use of parenthesis to denote either and/or and prefers to be explicit to avoid ambiguity. Response: Checked and avoided “and/or” and prefers to be explicit to avoid ambiguity. Response: Checked and avoided, and feedback on outcomes of behavior. Conclusions: Our results suggest that the majority of BCTs employed in interventions targeting persons with T2DM revolve around the promotion of self-regulatory behavior to manage the disease or to assist patients in performing health behaviors necessary to prevent further complications of the disease. Detailed reporting of the BCTs included in interventions targeting this population may facilitate the replication and further investigation of such interventions. %M 29025693 %R 10.2196/jmir.7135 %U http://www.jmir.org/2017/10/e348/ %U https://doi.org/10.2196/jmir.7135 %U http://www.ncbi.nlm.nih.gov/pubmed/29025693 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 10 %P e325 %T HealthyDads.ca: What Do Men Want in a Website Designed to Promote Emotional Wellness and Healthy Behaviors During the Transition to Parenthood? %A Da Costa,Deborah %A Zelkowitz,Phyllis %A Letourneau,Nicole %A Howlett,Andrew %A Dennis,Cindy-Lee %A Russell,Brian %A Grover,Steven %A Lowensteyn,Ilka %A Chan,Peter %A Khalifé,Samir %+ Department of Medicine, McGill University, 5252 deMaisonneuve W, Montreal, QC,, Canada, 1 514 934 1934 ext 44723, deborah.dacosta@mcgill.ca %K expectant fathers %K mental health %K needs assessment %D 2017 %7 11.10.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Up to 18% of men experience depression and/or anxiety during the transition to parenthood. Interventions designed specifically to promote the mental health of men during the transition to parenthood are scarce. Internet-delivered interventions may be acceptable and far-reaching in enhancing mental health, parenting knowledge, and healthy behaviors in expectant or new fathers. Objective: To guide the development of Healthydads.ca, a website designed to enhance mental health and healthy behaviors in expectant fathers, a needs assessment was conducted to identify fathers’ perspectives of barriers to seeking help for emotional wellness, informational needs, and factors affecting the decision to visit such a website. Methods: One hundred and seventy-four men whose partners were expecting, or had recently given birth, in 3 Canadian provinces (Quebec, Ontario, and Alberta) completed a Web-based survey inquiring about information needs related to psychosocial aspects of the transition to parenthood, lifestyle behaviors, parenting, and factors associated with the decision to visit a father-focused website. Results: Most men (155/174, 89.1%) reported accessing the Internet to obtain information on pregnancy and spent an average of 6.2 hours online per month. Seeking information about parenting on the Internet was reported by 67.2% (117/174) of men, with a mean of 4.4 hours per month of online searching. Top barriers to seeking help to improve emotional wellness during the perinatal period were: no time to seek help/assistance (130/174, 74.7%), lack of resources available in the health care system (126/174, 72.4%), financial costs associated with services (118/174, 67.8%), and feeling that one should be able to do it alone (113/174, 64.9%). Information needs that were rated highly included: parenting/infant care (52.9-81.6%), supporting (121/174, 69.5%) and improving (124/174, 71.3%) relationship with their partner, work-family balance (120/174, 69.0%), improving sleep (100/174, 57.5%), and managing stress (98/174, 56.3%). Perceiving the website as personally relevant (151/174, 86.8%), credible (141/174, 81.0%), effective (140/145, 80.5%), and having an easy navigation structure (141/174, 81.0%) were identified as important factors related to a first website visit. Providing useful (134/174, 77.0%) and easy to understand (158/174, 90.8%) information, which was also free of charge (156/174, 89.7%), were considered important for deciding to prolong a website visit. Providing the possibility to post questions to a health professional (133/174, 76.4%), adding new content regularly (119/174, 68.4%), and personal motivation (111/174, 63.8%) were factors identified that would encourage a revisit. Conclusions: Our findings demonstrate that there is substantial interest among expectant and new fathers for using Internet-delivered strategies to prepare for the transition to parenthood and support their mental health. Specific user and website features were identified to optimize the use of father-focused websites. %M 29021126 %R 10.2196/jmir.7415 %U http://www.jmir.org/2017/10/e325/ %U https://doi.org/10.2196/jmir.7415 %U http://www.ncbi.nlm.nih.gov/pubmed/29021126 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 10 %P e338 %T Encouraging Physical Activity in Patients With Diabetes: Intervention Using a Reinforcement Learning System %A Yom-Tov,Elad %A Feraru,Guy %A Kozdoba,Mark %A Mannor,Shie %A Tennenholtz,Moshe %A Hochberg,Irit %+ Microsoft Research, 13 Shenkar st., Herzeliya, 46875, Israel, 972 747111358, eladyt@yahoo.com %K reinforcement learning %K physical activity %K diabetes type 2 %D 2017 %7 10.10.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Regular physical activity is known to be beneficial for people with type 2 diabetes. Nevertheless, most of the people who have diabetes lead a sedentary lifestyle. Smartphones create new possibilities for helping people to adhere to their physical activity goals through continuous monitoring and communication, coupled with personalized feedback. Objective: The aim of this study was to help type 2 diabetes patients increase the level of their physical activity. Methods: We provided 27 sedentary type 2 diabetes patients with a smartphone-based pedometer and a personal plan for physical activity. Patients were sent short message service messages to encourage physical activity between once a day and once per week. Messages were personalized through a Reinforcement Learning algorithm so as to improve each participant’s compliance with the activity regimen. The algorithm was compared with a static policy for sending messages and weekly reminders. Results: Our results show that participants who received messages generated by the learning algorithm increased the amount of activity and pace of walking, whereas the control group patients did not. Patients assigned to the learning algorithm group experienced a superior reduction in blood glucose levels (glycated hemoglobin [HbA1c]) compared with control policies, and longer participation caused greater reductions in blood glucose levels. The learning algorithm improved gradually in predicting which messages would lead participants to exercise. Conclusions: Mobile phone apps coupled with a learning algorithm can improve adherence to exercise in diabetic patients. This algorithm can be used in large populations of diabetic patients to improve health and glycemic control. Our results can be expanded to other areas where computer-led health coaching of humans may have a positive impact. Summary of a part of this manuscript has been previously published as a letter in Diabetes Care, 2016. %M 29017988 %R 10.2196/jmir.7994 %U http://www.jmir.org/2017/10/e338/ %U https://doi.org/10.2196/jmir.7994 %U http://www.ncbi.nlm.nih.gov/pubmed/29017988 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 1 %N 2 %P e5 %T My Hypertension Education and Reaching Target (MyHEART): Development and Dissemination of a Patient-Centered Website for Young Adults with Hypertension %A Johnson,Heather M %A LaMantia,Jamie N %A Brown,Colleen M %A Warner,Ryan C %A Zeller,Laura M %A Haggart,Ryan C %A Stonewall,Keven %A Lauver,Diane R %+ Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, H4/512 Clinical Sciences Center, MC 3248, 600 Highland Avenue, Madison, WI, 53792, United States, 1 608 262 2075, hm2@medicine.wisc.edu %K hypertension %K young adults %K World Wide Web %K quality improvement %K patient engagement %D 2017 %7 25.09.2017 %9 Original Paper %J JMIR Cardio %G English %X Background: Young adults (18 to 39 years old) with hypertension have the lowest rates of blood pressure control (defined as blood pressure less than 140/90 mmHg) compared to other adult age groups. Approximately 1 in 15 young adults have high blood pressure, increasing their risk of future heart attack, stroke, congestive heart failure, and/or chronic kidney disease. Many young adults reported having few resources to address their needs for health education on managing cardiovascular risk. Objective: The goal of our study was to develop and disseminate a website with evidence-based, clinical information and health behavior resources tailored to young adults with hypertension. Methods: In collaboration with young adults, health systems, and community stakeholders, the My Hypertension Education and Reaching Target (MyHEART) website was created. A toolkit was also developed for clinicians and healthcare systems to disseminate the website within their organizations. The dissemination plan was guided by the Dissemination Planning Tool of the Agency for Healthcare Research and Quality (AHRQ). Results: Google Analytics data were acquired for January 1, 2017 to June 29, 2017. The MyHEART website received 1090 visits with 2130 page views; 18.99% (207/1090) were returning visitors. The majority (55.96%, 610/1090) approached the website through organic searches, 34.95% (381/1090) accessed the MyHEART website directly, and 5.96% (65/1090) approached through referrals from other sites. There was a spike in site visits around times of increased efforts to disseminate the website. Conclusions: The successfully implemented MyHEART website and toolkit reflect collaborative input from community and healthcare stakeholders to provide evidence-based, portable hypertension education to a hard-to-reach population. The MyHEART website and toolkit can support healthcare providers’ education and counseling with young adults and organizations’ hypertension population health goals. %M 29664482 %R 10.2196/cardio.8025 %U http://cardio.jmir.org/2017/2/e5/ %U https://doi.org/10.2196/cardio.8025 %U http://www.ncbi.nlm.nih.gov/pubmed/29664482 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 9 %P e321 %T Web-Based Aftercare for Women With Bulimia Nervosa Following Inpatient Treatment: Randomized Controlled Efficacy Trial %A Jacobi,Corinna %A Beintner,Ina %A Fittig,Eike %A Trockel,Mickey %A Braks,Karsten %A Schade-Brittinger,Carmen %A Dempfle,Astrid %+ Institut für Klinische Psychologie und Psychotherapie, Professur Klinische Psychologie & E-Mental Health, Technische Universität Dresden, Chemnitzer Strasse 46, Dresden, 01187, Germany, 49 351 463 38576, corinna.jacobi@tu-dresden.de %K bulimia nervosa %K web-based intervention %K aftercare %K relapse %D 2017 %7 22.09.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Relapse rates in bulimia nervosa (BN) are high even after successful treatment, but patients often hesitate to take up further treatment. An easily accessible program might help maintain treatment gains. Encouraged by the effects of Web-based eating disorder prevention programs, we developed a manualized, Web-based aftercare program (IN@) for women with BN following inpatient treatment. Objective: The objective of this study was to determine the efficacy of the web-based guided, 9-month, cognitive-behavioral aftercare program IN@ for women with BN following inpatient treatment. Methods: We conducted a randomized controlled efficacy trial in 253 women with DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, fourth edition) BN and compared the results of IN@ with treatment as usual (TAU). Assessments were carried out at hospital admission (T0), hospital discharge/baseline (T1), postintervention (T2; 9 months after baseline), 9-month follow-up (T3; 18 months after baseline). The primary outcome, abstinence from binge eating and compensatory behaviors during the 2 months preceding T2, was analyzed by intention to treat, using logistic regression analyses. Frequencies of binge eating and vomiting episodes, and episodes of all compensatory behaviors were analyzed using mixed effects models. Results: At T2, data from 167 women were available. There were no significant differences in abstinence rates between the TAU group (n=24, 18.9%) and the IN@ group (n=27, 21.4%; odds ratio, OR=1.29; P=.44). The frequency of vomiting episodes in the IN@ group was significantly (46%) lower than in the TAU group (P=.003). Moderator analyses revealed that both at T2 and T3, women of the intervention group who still reported binge eating and compensatory behaviors after inpatient treatment benefited from IN@, whereas women who were already abstinent after the inpatient treatment did not (P=.004; P=.002). Additional treatment utilization was high in both groups between baseline and follow-up. Conclusions: Overall, data from this study suggest moderate effects of IN@. High rates of outpatient treatment utilization after inpatient treatment may have obscured potential intervention effects on abstinence. An aftercare intervention might be more beneficial as part of a stepped-care approach. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 08870215; http://www.isrctn.com/ISRCTN08870215 (Archived by WebCite at http://www.webcitation.org/6soA5bIit) %M 28939544 %R 10.2196/jmir.7668 %U http://www.jmir.org/2017/9/e321/ %U https://doi.org/10.2196/jmir.7668 %U http://www.ncbi.nlm.nih.gov/pubmed/28939544 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 9 %P e311 %T Personalized Hypertension Management Using Patient-Generated Health Data Integrated With Electronic Health Records (EMPOWER-H): Six-Month Pre-Post Study %A Lv,Nan %A Xiao,Lan %A Simmons,Martha L %A Rosas,Lisa G %A Chan,Albert %A Entwistle,Martin %+ Ares Health Solutions, Suite 202, 445 S. Los Robles Ave, Pasadena, CA, 91101, United States, 1 858 717 0465, ment@areshs.com %K electronic health records %K disease management %K hypertension %K patient participation %K blood pressure %K patient-centered care %K home blood pressure monitoring %D 2017 %7 19.09.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: EMPOWER-H (Engaging and Motivating Patients Online With Enhanced Resources-Hypertension) is a personalized-care model facilitating engagement in hypertension self-management utilizing an interactive Web-based disease management system integrated with the electronic health record. The model is designed to support timely patient-provider interaction by incorporating decision support technology to individualize care and provide personalized feedback for patients with chronic disease. Central to this process were patient-generated health data, including blood pressure (BP), weight, and lifestyle behaviors, which were uploaded using a smartphone. Objective: The aim of this study was to evaluate the program among patients within primary care already under management for hypertension and with uncontrolled BP. Methods: Using a 6-month pre-post design, outcome measures included office-measured and home-monitored BP, office-measured weight, intervention contacts, diet, physical activity, smoking, knowledge, and health-related quality of life. Results: At 6 months, 55.9% of participants (N=149) achieved office BP goals (<140/90 mm Hg; P<.001) and 86.0% achieved clinically meaningful reduction in office BP (reduction in systolic BP [SBP] ≥5 mm Hg or diastolic BP [DBP] ≥3 mm Hg). At baseline, 25.2% of participants met home BP goals (<135/85 mm Hg), and this percentage significantly increased to 71.4% (P<.001) at 6 months. EMPOWER-H also significantly reduced both office and home SBP and DBP, decreased office-measured weight and consumption of high-salt and high-fat foods (all P<.005), and increased intake of fruit and vegetables, minutes of aerobic exercise, and hypertension knowledge (all P<.05). Patients with higher home BP upload frequencies had significantly higher odds of achieving home BP goals. Patients receiving more total intervention, behavioral, pharmaceutical contacts had significantly lower odds of achieving home BP goals but higher improvements in office BP (all P<.05). Conclusions: EMPOWER-H significantly improved participants’ office-measured and home-monitored BP, weight, and lifestyle behaviors, suggesting that technologically enabled BP home-monitoring, with structured use of patient-generated health data and a personalized care-plan facilitating patient engagement, can support effective clinical management. The experience gained in this study provides support for the feasibility and value of using carefully managed patient-generated health data in the day-to-day clinical management of patients with chronic conditions. A large-scale, real-world study to evaluate sustained effectiveness, cost-effectiveness, and scalability is warranted. %M 28928111 %R 10.2196/jmir.7831 %U http://www.jmir.org/2017/9/e311/ %U https://doi.org/10.2196/jmir.7831 %U http://www.ncbi.nlm.nih.gov/pubmed/28928111 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 9 %P e309 %T User Acceptance of Computerized Cognitive Behavioral Therapy for Depression: Systematic Review %A Rost,Theresia %A Stein,Janine %A Löbner,Margrit %A Kersting,Anette %A Luck-Sikorski,Claudia %A Riedel-Heller,Steffi G %+ Institute of Social Medicine, Occupational Health and Public Health, Medical Faculty, University of Leipzig, Building A, 3rd Fl., Philipp-Rosenthal-Str. 55, Leipzig, 04103, Germany, 49 3419715408, Steffi.Riedel-Heller@medizin.uni-leipzig.de %K computerized cognitive behavior therapy %K depression %K user acceptance %K systematic review %K review %K behavior therapy %K depressive disorder %D 2017 %7 13.09.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Computerized cognitive behavioral therapy (cCBT) has been proven to be effective in depression care. Moreover, cCBT packages are becoming increasingly popular. A central aspect concerning the take-up and success of any treatment is its user acceptance. Objective: The aim of this study was to update and expand on earlier work on user acceptance of cCBT for depression. Methods: This paper systematically reviewed quantitative and qualitative studies regarding the user acceptance of cCBT for depression. The initial search was conducted in January 2016 and involved the following databases: Web of Science, PubMed, the Cochrane Library, and PsycINFO. Studies were retained if they described the explicit examination of the user acceptance, experiences, or satisfaction related to a cCBT intervention, if they reported depression as a primary outcome, and if they were published in German or English from July 2007 onward. Results: A total of 1736 studies were identified, of which 29 studies were eligible for review. User acceptance was operationalized and analyzed very heterogeneously. Eight studies reported a very high level of acceptance, 17 indicated a high level of acceptance, and one study showed a moderate level of acceptance. Two qualitative studies considered the positive and negative aspects concerning the user acceptance of cCBT. However, a substantial proportion of reviewed studies revealed several methodical shortcomings. Conclusions: In general, people experience cCBT for depression as predominantly positive, which supports the potential role of these innovative treatments. However, methodological challenges do exist in terms of defining user acceptance, clear operationalization of concepts, and measurement. %M 28903893 %R 10.2196/jmir.7662 %U http://www.jmir.org/2017/9/e309/ %U https://doi.org/10.2196/jmir.7662 %U http://www.ncbi.nlm.nih.gov/pubmed/28903893 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 9 %P e312 %T Effectiveness of a Web-Based Tailored Intervention With Virtual Assistants Promoting the Acceptability of HPV Vaccination Among Mothers of Invited Girls: Randomized Controlled Trial %A Pot,Mirjam %A Paulussen,Theo GWM %A Ruiter,Robert AC %A Eekhout,Iris %A de Melker,Hester E %A Spoelstra,Maxine EA %A van Keulen,Hilde M %+ Netherlands Organization for Applied Scientific Research (TNO), Child Health, Schipholweg 77, Leiden, 2316 ZL, Netherlands, 31 643234293, mirjampot90@gmail.com %K vaccination %K health promotion %K web-based intervention computer-tailoring %K randomized controlled trial %D 2017 %7 06.09.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: In 2010, the human papillomavirus (HPV) vaccination was introduced in the Dutch National Immunization Program for 12-year-old girls, aiming to reduce the incidence of cervical cancer in women. HPV vaccination uptake turned out to be lower than expected: 61% versus 70%, respectively. Mothers were shown to play the most important role in the immunization decision about this vaccination. They had also expressed their need for interactive personal information about the HPV vaccination over and above the existing universal general information. To improve the effectiveness of the existing education about the HPV vaccination, we systematically developed a Web-based tailored intervention with virtual assistants providing mothers of girls to be invited with tailored feedback on their decision making about the HPV vaccination. Objective: The aim of this study was to evaluate the effectiveness of the Web-based tailored intervention for promoting HPV vaccination acceptance by means of a randomized controlled trial (RCT). Methods: Mothers were recruited via the Dutch vaccination register (Praeventis) (n=36,000) and three Web-based panels (n=2483). Those who gave informed consent (N=8062) were randomly assigned to the control (n=4067) or intervention condition (n=3995). HPV vaccination uptake, as registered by Praeventis once the HPV vaccination round was completed, was used as the primary outcome. Secondary outcomes were differential scores across conditions between baseline (before the provided access to the new tailored intervention) and follow-up (just before the first vaccination) regarding the mothers’ degree of informed decision making (IDM), decisional conflict, and critical determinants of HPV vaccination uptake among which are intention, attitude, risk perception, and outcome beliefs. Results: Intention-to-treat analysis (N=8062) showed a significant positive effect of the intervention on IDM, decisional conflict, and nearly all determinants of HPV vaccination uptake (P<.001). No effect was found on uptake (P=.60). This may be attributed to the overall high uptake rates in both conditions. Mothers evaluated the intervention as highly positive, including the website as well as the virtual assistants that were used to deliver the tailored feedback. Conclusions: This computer-tailored intervention has the potential to improve HPV vaccination acceptability and IDM and to decrease decisional conflict among mothers of invited girls. Implications for future research are discussed. Trial Registration: Trialregister.nl NTR4935; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4935 (Archived by WebCite at http://www.webcitation.org/6srT7l9EM) %M 28877862 %R 10.2196/jmir.7449 %U http://www.jmir.org/2017/9/e312/ %U https://doi.org/10.2196/jmir.7449 %U http://www.ncbi.nlm.nih.gov/pubmed/28877862 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 8 %P e303 %T Web-Based Mindfulness Interventions for People With Physical Health Conditions: Systematic Review %A Toivonen,Kirsti I %A Zernicke,Kristin %A Carlson,Linda E %+ Department of Psychosocial Resources, Holy Cross Site, Tom Baker Cancer Centre, Holy Cross Centre, 2nd Fl., 2202 2nd St SW, Calgary, AB, T2S 3C1, Canada, 1 403 355 3209, l.carlson@ucalgary.ca %K Internet %K mindfulness %K review %D 2017 %7 31.08.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Mindfulness-based interventions (MBIs) are becoming increasingly popular for helping people with physical health conditions. Expanding from traditional face-to-face program delivery, there is growing interest in Web-based application of MBIs, though Web-based MBIs for people with physical health conditions specifically have not been thoroughly reviewed to date. Objective: The objective of this paper was to review Web-based MBIs for people with physical health conditions and to examine all outcomes reported (eg, efficacy or effectiveness for physical changes or psychological changes; feasibility). Methods: Databases PubMed, PsycINFO, Science Direct, CINAHL Plus, and Web of Science were searched. Full-text English papers that described any Web-based MBI, examining any outcome, for people with chronic physical health conditions were included. Randomized, nonrandomized, controlled, and uncontrolled trials were all included. Extracted data included intervention characteristics, population characteristics, outcomes, and quality indicators. Intervention characteristics (eg, synchronicity and guidance) were examined as potential factors related to study outcomes. Results: Of 435 publications screened, 19 published papers describing 16 studies were included. They examined Web-based MBIs for people with cancer, chronic pain or fibromyalgia, irritable bowel syndrome (IBS), epilepsy, heart disease, tinnitus, and acquired brain injury. Overall, most studies reported positive effects of Web-based MBIs compared with usual care on a variety of outcomes including pain acceptance, coping measures, and depressive symptoms. There were mixed results regarding the effectiveness of Web-based MBIs compared with active control treatment conditions such as cognitive behavioral therapy. Condition-specific symptoms (eg, cancer-related fatigue and IBS symptoms) targeted by treatment had the largest effect size improvements following MBIs. Results are inconclusive regarding physical variables. Conclusions: Preliminary evidence suggests that Web-based MBIs may be helpful in alleviating symptom burden that those with physical health conditions can experience, particularly when interventions are tailored for specific symptoms. There was no evidence of differences between synchronous versus asynchronous or facilitated versus self-directed Web-based MBIs. Future investigations of Web-based MBIs should evaluate the effects of program adherence, effects on mindfulness levels, and whether synchronous or asynchronous, or facilitated or self-directed interventions elicit greater improvements. %M 28860106 %R 10.2196/jmir.7487 %U https://www.jmir.org/2017/8/e303/ %U https://doi.org/10.2196/jmir.7487 %U http://www.ncbi.nlm.nih.gov/pubmed/28860106 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 8 %P e296 %T Text Messaging Interventions on Cancer Screening Rates: A Systematic Review %A Uy,Catherine %A Lopez,Jennifer %A Trinh-Shevrin,Chau %A Kwon,Simona C %A Sherman,Scott E %A Liang,Peter S %+ Department of Medicine, VA New York Harbor Manhattan Medical Center, 11N, Gastroenterology, 423 E 23rd St, New York, NY, 10010, United States, 1 212 686 7500 ext 5745, Peter.Liang@nyumc.org %K text messaging %K early detection of cancer %K breast neoplasms %K colorectal neoplasms %K lung neoplasms %K mHealth %K uterine cervical neoplasms %D 2017 %7 24.08.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite high-quality evidence demonstrating that screening reduces mortality from breast, cervical, colorectal, and lung cancers, a substantial portion of the population remains inadequately screened. There is a critical need to identify interventions that increase the uptake and adoption of evidence-based screening guidelines for preventable cancers at the community practice level. Text messaging (short message service, SMS) has been effective in promoting behavioral change in various clinical settings, but the overall impact and reach of text messaging interventions on cancer screening are unknown. Objective: The objective of this systematic review was to assess the effect of text messaging interventions on screening for breast, cervical, colorectal, and lung cancers. Methods: We searched multiple databases for studies published between the years 2000 and 2017, including PubMed, EMBASE, and the Cochrane Library, to identify controlled trials that measured the effect of text messaging on screening for breast, cervical, colorectal, or lung cancers. Study quality was evaluated using the Cochrane risk of bias tool. Results: Our search yielded 2238 citations, of which 31 underwent full review and 9 met inclusion criteria. Five studies examined screening for breast cancer, one for cervical cancer, and three for colorectal cancer. No studies were found for lung cancer screening. Absolute screening rates for individuals who received text message interventions were 0.6% to 15.0% higher than for controls. Unadjusted relative screening rates for text message recipients were 4% to 63% higher compared with controls. Conclusions: Text messaging interventions appear to moderately increase screening rates for breast and cervical cancer and may have a small effect on colorectal cancer screening. Benefit was observed in various countries, including resource-poor and non-English-speaking populations. Given the paucity of data, additional research is needed to better quantify the effectiveness of this promising intervention. %M 28838885 %R 10.2196/jmir.7893 %U http://www.jmir.org/2017/8/e296/ %U https://doi.org/10.2196/jmir.7893 %U http://www.ncbi.nlm.nih.gov/pubmed/28838885 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 8 %P e298 %T A Web-Based and Print-Based Computer-Tailored Physical Activity Intervention for Prostate and Colorectal Cancer Survivors: A Comparison of User Characteristics and Intervention Use %A Golsteijn,Rianne Henrica Johanna %A Bolman,Catherine %A Peels,Denise Astrid %A Volders,Esmee %A de Vries,Hein %A Lechner,Lilian %+ Department of Psychology and Educational Sciences, Open University of the Netherlands, PO Box 2960, Heerlen, 6401 DL, Netherlands, 31 455762539, rianne.golsteijn@ou.nl %K eHealth %K web-based intervention %K print-delivered intervention %K computer tailoring %K intervention usage %K physical activity %K prostate cancer %K colorectal cancer %K cancer survivorship %D 2017 %7 23.08.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Physical activity (PA) is beneficial in improving negative physical and psychological effects of cancer. The rapidly increasing number of cancer survivors, resulting from aging and improved cancer care, emphasizes the importance to develop and provide low cost, easy accessible PA programs. Such programs could be provided through the Internet, but that could result in the exclusion of cancer survivors not familiar with the Internet. Therefore, we developed a computer-tailored PA intervention for prostate and colorectal cancer survivors in which both Web-based and print materials are provided, and participants can choose their own preferred delivery mode. Objective: The aim of this study was to assess participants’ characteristics related to delivery mode and use of intervention materials. Methods: We studied characteristics of participants using Web-based and printed intervention materials in a randomized controlled trial (RCT). Prostate and colorectal cancer survivors recruited from hospitals were randomized to OncoActive (computer-tailored PA intervention) or a usual-care control group. OncoActive participants received both Web-based and printed materials. Participants were classified into initial print- or Web-based participants based on their preferred mode of completion of the first questionnaire, which was needed for the computer-tailored PA advice. Intervention material use during the remainder of the intervention was compared for initial print- or Web-based participants. Additionally, participants were classified into those using only print materials and those using Web-based materials. Differences in participant characteristics and intervention material use were studied through analysis of variance (ANOVAs), chi-square tests, and logistic regressions. Results: The majority of the participants in the intervention group were classified as initial Web-based participants (170/249, 68.3%), and 84.9% (191/249) used Web-based intervention materials. Dropout was low (15/249, 6.0%) and differed between initial Web-based (4/170, 2.4%) and print-based (11/79, 14%) participants. Participants were less likely to start Web-based with higher age (odds ratio [OR]=0.93), longer time since last treatment (OR=0.87), and higher fatigue (OR=0.96), and more likely with higher education (OR=4.08) and having completed treatments (OR=5.58). Those who were older (OR=0.93) and post treatment for a longer time (OR=0.86) were less likely to use Web-based intervention materials. Initial print-based participants predominantly used print-based materials, whereas initial Web-based participants used both print- and Web-based materials. Conclusions: To our knowledge, this is one of the first studies that assessed participant characteristics related to delivery mode in an intervention in which participants had a free choice of delivery modes. Use of print-based materials among the initial Web-based participants was substantial, indicating the importance of print-based materials. According to our findings, it may be important to offer Web- and print-based materials alongside each other. Providing Web-based materials only may exclude older, less educated, more fatigued, or currently treated participants; these groups are especially more vulnerable and could benefit most from PA interventions. %M 28835353 %R 10.2196/jmir.7838 %U http://www.jmir.org/2017/8/e298/ %U https://doi.org/10.2196/jmir.7838 %U http://www.ncbi.nlm.nih.gov/pubmed/28835353 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 8 %P e287 %T Sugarsquare, a Web-Based Patient Portal for Parents of a Child With Type 1 Diabetes: Multicenter Randomized Controlled Feasibility Trial %A Boogerd,Emiel %A Maas-Van Schaaijk,Nienke M %A Sas,Theo C %A Clement-de Boers,Agnes %A Smallenbroek,Mischa %A Nuboer,Roos %A Noordam,Cees %A Verhaak,Chris M %+ Department of Medical Psychology, Radboud University Medical Center, Geert Groote Plein Zuid 10, PO Box 9101, Nijmegen, 6500 BH, Netherlands, 31 0243655232, emiel.boogerd@radboudumc.nl %K diabetes mellitus, type 1 %K parenting %K health communication %K peer group %K telemedicine %K Internet %D 2017 %7 22.08.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Raising a child with type 1 diabetes (T1D) means combining the demands of the disease management with everyday parenting, which is associated with increased levels of distress. A Web-based patient portal, Sugarsquare, was developed to support parents, by providing online parent-professional communication, online peer support and online disease information. Objective: The first aim of this study was to assess the feasibility of conducting a multicenter, randomized controlled trial in Dutch parents of a child with T1D. The second aim was to assess the feasibility of implementing Sugarsquare in clinical practice. Methods: The parents of 105 children (N=105) with T1D below the age of 13 participated in a 6-month multicenter randomized controlled feasibility trial. They were randomly assigned to an experimental (n=54, usual care and Sugarsquare) or a control group (n=51, usual care). Attrition rates and user statistics were gathered to evaluate feasibility of the trial and implementation. To determine potential efficacy, the parenting stress index (PSI-SF) was assessed at baseline (T0) and after 6 months (T1). Results: Of a potential population of parents of 445 children, 189 were willing to participate (enrollment refusal=57.5%, n=256), 142 filled in the baseline questionnaire (baseline attrition rate=25%, n=47), and 105 also filled in the questionnaire at T1 (post randomization attrition rate during follow-up=26%, n=32). As such, 24% of the potential population participated. Analysis in the experimental group (n=54) revealed a total of 32 (59%) unique users, divided into 12 (38%) frequent users, 9 (28%) incidental users, and 11 (34%) low-frequent users. Of the total of 44 professionals, 34 (77%) logged in, and 32 (73%) logged in repeatedly. Analysis of the user statistics in the experimental group further showed high practicability and integration in all users, moderate acceptability and demand in parents, and high acceptability and demand in health care professionals. Baseline parenting stress index scores were related to the parents’ frequency of logging on (ρ=.282, P=.03) and page-views (ρ=.304, P=.01). No significant differences in change in parenting stress between experimental and control group were found (F3,101=.49, P=.49). Conclusions: The trial can be considered feasible, considering the average enrollment refusal rate, baseline attrition rate and postrandomization attrition rate, compared to other eHealth studies, although lower than hypothesized. Implementing Sugarsquare in clinical practice was partly feasible, given moderate demand and acceptability in parent users and lack of potential efficacy. Parents who reported higher levels of parenting stress used Sugarsquare more often than other parents, although Sugarsquare did not reduce parenting stress. These results indicate that Web-based interventions are a suitable way of providing parents of children with T1D with additional support. Future studies should determine how Sugarsquare could reduce parenting stress, for instance by adding targeted interventions. Factors potentially contributing to successful implementation are suggested. Trial Registration: Nederlands Trial Register Number: NTR3643; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3643 (Archived by WebCite at http://www.webcitation.org/6qihOVCi6) %M 28830853 %R 10.2196/jmir.6639 %U http://www.jmir.org/2017/8/e287/ %U https://doi.org/10.2196/jmir.6639 %U http://www.ncbi.nlm.nih.gov/pubmed/28830853 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 1 %N 1 %P e1 %T The Impact of Participant Characteristics on Use and Satisfaction of a Web-Based Computer-Tailored Chronic Obstructive Pulmonary Disease Self-Management Intervention: A Process Evaluation %A Voncken-Brewster,Viola %A Amoureus,Mylène %A de Vries,Hein %A Nagykaldi,Zsolt %A Winkens,Bjorn %A van der Weijden,Trudy %A Tange,Huibert %+ Department of Family Medicine, Care and Public Health Research Institute, Maastricht University Medical Center, Maastricht University, PO Box 616, Maastricht,, Netherlands, 31 43 388 2230, viola.voncken@maastrichtuniversity.nl %K Internet intervention %K computer tailoring %K application use %K participant characteristics %K COPD %K self-management %K behavior change %K process evaluation %D 2017 %7 21.08.2017 %9 Original Paper %J JMIR Formativ Res %G English %X Background: A randomized controlled trial (RCT) showed that a Web-based computer-tailored self-management intervention for people with or at risk for chronic obstructive pulmonary disease (COPD) did not have a significant treatment effect. Process evaluation measures such as application use and satisfaction with the intervention can help understand these results. Objectives: The aim of this paper is to uncover reasons for suboptimal application use, evaluate satisfaction with the intervention, and investigate which participant characteristics predict application use and user satisfaction. Methods: Participants were recruited through 2 different channels: an online panel and general practice. The intervention group received the intervention, which consisted of 2 modules (smoking cessation and physical activity). The control group received no intervention. The study employed a mixed methods design. Quantitative and qualitative data were gathered assessing participant characteristics, application use, reasons for not using the application, and satisfaction with the intervention. Results: The RCT included 1325 participants. The proportion of individuals who participated was significantly higher in the online group (4072/6844, 59.5%) compared to the general practice group (43/335, 12.8%) (P<.001). Application use was low. Of all participants in the intervention group, 52.9% (348/658) initiated use of one or both modules, 36.0% (237/658) completed an intervention component (prolonged use), and 16.6% (109/658) revisited one of the modules after completing an intervention component (sustained use). Older age, established diagnosis of COPD, or experiencing breathlessness predicted sustained use. Participant satisfaction with the 2 modules was 6.7 (SD 1.6) on a scale from 0 to 10. The interviews revealed that a computer application was believed not to be sufficient and the help of a health care professional was necessary. Participants with a greater intention to change were more satisfied with the application. Conclusions: The application was not used sufficiently. Study materials should be further tailored to younger individuals, those at risk for COPD, and those who do not experience breathlessness in order to increase sustained use among them. Involvement of a health care professional could improve satisfaction with the intervention and potentially increase engagement with the intervention materials. However, to make this possible, recruitment in general practice needs to be improved. Recommendations are made for improving the study design, strengthening the intervention (eg, practice facilitation), and linking the computer application to interaction with a health care provider. %M 30684399 %R 10.2196//formative.6585 %U https://formative.jmir.org/2017/1/e1/ %U https://doi.org/10.2196//formative.6585 %U http://www.ncbi.nlm.nih.gov/pubmed/30684399 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 8 %P e291 %T The Effect of Integration of Self-Management Web Platforms on Health Status in Chronic Obstructive Pulmonary Disease Management in Primary Care (e-Vita Study): Interrupted Time Series Design %A Talboom-Kamp,Esther PWA %A Verdijk,Noortje A %A Kasteleyn,Marise J %A Harmans,Lara M %A Talboom,Irvin JSH %A Looijmans-van den Akker,Ingrid %A van Geloven,Nan %A Numans,Mattijs E %A Chavannes,Niels H %+ Leiden University Medical Center, Public Health and Primary Care Department, Albinusdreef 2, 2333ZA Leiden, Netherlands, 31 71 526 9111, e.talboom@saltro.nl %K COPD %K CCQ %K health status %K eHealth %K self-management %K integrated disease management %K self-efficacy %K Web-based platform %K primary care %K chronically ill %K blended care %D 2017 %7 16.08.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Worldwide nearly 3 million people die from chronic obstructive pulmonary disease (COPD) every year. Integrated disease management (IDM) improves quality of life for COPD patients and can reduce hospitalization. Self-management of COPD through eHealth is an effective method to improve IDM and clinical outcomes. Objectives: The objective of this implementation study was to investigate the effect of 3 chronic obstructive pulmonary disease eHealth programs applied in primary care on health status. The e-Vita COPD study compares different levels of integration of Web-based self-management platforms in IDM in 3 primary care settings. Patient health status is examined using the Clinical COPD Questionnaire (CCQ). Methods: The parallel cohort design includes 3 levels of integration in IDM (groups 1, 2, 3) and randomization of 2 levels of personal assistance for patients (group A, high assistance, group B, low assistance). Interrupted time series (ITS) design was used to collect CCQ data at multiple time points before and after intervention, and multilevel linear regression modeling was used to analyze CCQ data. Results: Of the 702 invited patients, 215 (30.6%) registered to a platform. Of these, 82 participated in group 1 (high integration IDM), 36 in group 1A (high assistance), and 46 in group 1B (low assistance); 96 participated in group 2 (medium integration IDM), 44 in group 2A (high assistance) and 52 in group 2B (low assistance); also, 37 participated in group 3 (no integration IDM). In the total group, no significant difference was found in change in CCQ trend (P=.334) before (–0.47% per month) and after the intervention (–0.084% per month). Also, no significant difference was found in CCQ changes before versus after the intervention between the groups with high versus low personal assistance. In all subgroups, there was no significant change in the CCQ trend before and after the intervention (group 1A, P=.237; 1B, P=.991; 2A, P=.120; 2B, P=.166; 3, P=.945). Conclusions: The e-Vita eHealth-supported COPD programs had no beneficial impact on the health status of COPD patients. Also, no differences were found between the patient groups receiving different levels of personal assistance. Trial Registration: Netherlands Trial Registry NTR4098; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4098 (Archived by WebCite at http://www.webcitation.org/6sbM5PayG) %M 28814380 %R 10.2196/jmir.8262 %U http://www.jmir.org/2017/8/e291/ %U https://doi.org/10.2196/jmir.8262 %U http://www.ncbi.nlm.nih.gov/pubmed/28814380 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 4 %N 3 %P e33 %T Preliminary Evaluation of a Brief Web and Mobile Phone Intervention for Men With Depression: Men’s Positive Coping Strategies and Associated Depression, Resilience, and Work and Social Functioning %A Fogarty,Andrea Susan %A Proudfoot,Judy %A Whittle,Erin Louise %A Clarke,Janine %A Player,Michael J %A Christensen,Helen %A Wilhelm,Kay %+ Black Dog Institute, UNSW, Hospital Rd, Randwick, 2031, Australia, 61 293829273, a.fogarty@unsw.edu.au %K depression %K eHealth %K men %K mental health %D 2017 %7 10.08.2017 %9 Original Paper %J JMIR Ment Health %G English %X Background: Previous research has identified that men experiencing depression do not always access appropriate health services. Web-based interventions represent an alternative treatment option for men, are effective in reducing anxiety and depression, and have potential for wide dissemination. However, men do not access Web-based programs at the same rate as women. Programs with content explicitly tailored to men’s mental health needs are required. Objective: This study evaluated the applicability of Man Central, a new Web and mobile phone intervention for men with depression. The impact of the use of Man Central on depression, resilience, and work and social functioning was assessed. Methods: A recruitment flier was distributed via social media, email networks, newsletters, research registers, and partner organizations. A single-group, repeated measures design was used. The primary outcome was symptoms of depression. Secondary outcomes included externalizing symptoms, resilience, and work and social functioning. Man Central comprises regular mood, symptom, and behavior monitoring, combined with three 15-min interactive sessions. Clinical features are grounded in cognitive behavior therapy and problem-solving therapy. A distinguishing feature is the incorporation of positive strategies identified by men as useful in preventing and managing depression. Participants were directed to use Man Central for a period of 4 weeks. Linear mixed modeling with intention-to-treat analysis assessed associations between the intervention and the primary and secondary outcomes. Results: A total of 144 men aged between 18 and 68 years and with at least mild depression enrolled in the study. The symptoms most often monitored by men included motivation (471 instances), depression (399), sleep (323), anxiety (316), and stress (262). Reminders were scheduled by 60.4% (87/144). Significant improvements were observed in depression symptoms (P<.001, d=0.68), depression risk, and externalizing symptoms (P<.001, d=0.88) and work and social functioning (P<.001, d=0.78). No change was observed in measures of resilience. Participants reported satisfaction with the program, with a majority saying that it was easy (42/51, 82%) and convenient (41/51, 80%) to use. Study attrition was high; 27.1% (39/144) and 8.3% (12/144) of the participants provided complete follow-up data and partial follow-up data, respectively, whereas the majority (93/144, 64.6%) did not complete follow-up measures. Conclusions: This preliminary evaluation demonstrated the potential of using electronic health (eHealth) tools to deliver self-management strategies to men with depressive symptoms. Man Central may meet the treatment needs of a subgroup of depressed men who are willing to engage with an e-mental health program. With further research, it may provide an acceptable option to those unwilling or unable to access traditional mental health services. Given the limitations of the study design, prospective studies are required, using controlled designs to further elucidate the effect of the program over time. %M 28798009 %R 10.2196/mental.7769 %U http://mental.jmir.org/2017/3/e33/ %U https://doi.org/10.2196/mental.7769 %U http://www.ncbi.nlm.nih.gov/pubmed/28798009 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 8 %P e284 %T A Peer-Led, Social Media-Delivered, Safer Sex Intervention for Chinese College Students: Randomized Controlled Trial %A Sun,Wai Han %A Wong,Carlos King Ho %A Wong,William Chi Wai %+ Department of Family Medicine and Primary Care, The University of Hong Kong, Ap Lei Chau Clinic, 3/F, 161 Main Street, Ap Lei Chau, Hong Kong,, China (Hong Kong), 852 2518 5657, wongwcw@hku.hk %K sex education %K social media %K randomized controlled trial %D 2017 %7 09.08.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: The peer-led, social media-delivered intervention is an emerging method in sexual health promotion. However, no research has yet investigated its effectiveness as compared with other online channels or in an Asian population. Objective: The objective of this study is to compare a peer-led, social media-delivered, safer sex intervention with a sexual health website. Both conditions target Chinese college students in Hong Kong. Methods: A randomized controlled trial was conducted with a peer-led, safer sex Facebook group as the intervention and an existing online sexual health website as the control. The intervention materials were developed with peer input and followed the information-motivation-behavioral skills model; the intervention was moderated by peer educators. The participants filled out the online questionnaires before and after the 6-week intervention period. Outcome evaluations included safer sex attitudes, behavioral skills, and behaviors, while process evaluation focused on online experience, online-visiting frequency, and online engagement. The effect of online-visiting frequency and online engagement on outcome variables was investigated. Results: Of 196 eligible participants—100 in the control group and 96 in the intervention group—who joined the study, 2 (1.0%) control participants joined the Facebook group and 24 of the remaining 194 participants (12.4%) were lost to follow-up. For the process evaluation, participants in the intervention group reported more satisfying online experiences (P<.001) and a higher level of online-visiting frequency (P<.001). They also had more positive comments when compared with the control group. For outcome evaluation, within-group analysis showed significant improvement in condom use attitude (P=.02) and behavioral skills (P<.001) in the intervention group, but not in the control group. No significant between-group difference was found. After adjusting for demographic data, increased online-visiting frequency was associated with better contraceptive use behavioral intention (P=.05), better behavioral skills (P=.02), and more frequent condom use (P=.04). Conclusions: A peer-led, social media-delivered, safer sex intervention was found to be feasible and effective in improving attitudes toward condom use and behavioral skills, but was not significantly more effective than a website. Future research may focus on the long-term effectiveness and cost-effectiveness of this popular method, as well as the potential cultural differences of using social media between different countries. Trial Registration: Chinese Clinical Trial Registry (ChiCTR): ChiCTR-IOR-16009495; http://www.chictr.org.cn/showprojen.aspx?proj=16234 (Archived by WebCite at http://www.webcitation.org/6s0Fc2L9T) %M 28793980 %R 10.2196/jmir.7403 %U http://www.jmir.org/2017/8/e284/ %U https://doi.org/10.2196/jmir.7403 %U http://www.ncbi.nlm.nih.gov/pubmed/28793980 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 8 %P e266 %T How do eHealth Programs for Adolescents With Depression Work? A Realist Review of Persuasive System Design Components in Internet-Based Psychological Therapies %A Wozney,Lori %A Huguet,Anna %A Bennett,Kathryn %A Radomski,Ashley D %A Hartling,Lisa %A Dyson,Michele %A McGrath,Patrick J %A Newton,Amanda S %+ Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, 3-526 Edmonton Clinic Health Academy, 11405 87 Avenue, Edmonton, AB, T6G 1C9, Canada, 1 780 248 5581, mandi.newton@ualberta.ca %K persuasive systems %K mental health %K Internet-based intervention %K review %K psychological therapy %D 2017 %7 09.08.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Major depressive disorders are common among adolescents and can impact all aspects of their daily life. Traditional therapies, cognitive behavioral therapy (CBT), and interpersonal psychotherapy (IPT) have been delivered face-to-face. However, Internet-based (online) delivery of these therapies is emerging as an option for adolescents. Internet-based CBT and IPT involve therapeutic content, interaction between the user and the system, and different technological features embedded into the online program (eg, multimedia). Studies of Internet-based CBT and IPT for adolescent depression differ on all three aspects, and variable, positive therapy effects have been reported. A better understanding of the treatment conditions that influence therapy outcomes is important to designing and evaluating these novel therapies. Objective: Our aim was to examine the technological and program delivery features of Internet-based CBT and IPT for adolescent depression and to document their potential relation to treatment outcomes and program use. Methods: We performed a realist synthesis. We started with an extensive search of published and gray literature. We included intervention studies that evaluated Internet-based CBT or IPT for adolescent depression. We included mixed-methods and qualitative studies, theoretical papers, and policy/implementation documents if they included a focus on how Internet-based psychological therapy is proposed to work for adolescents with depression/depressive symptoms. We used the Mixed-Methods Appraisal Tool to assess the methodological quality of studies. We used the Persuasive System Design (PSD) model as a framework for data extraction and analysis to examine how Internet-based CBT and IPT, as technology-based systems, influence the attitudes and behaviors of system users. PSD components described for the therapies were linked to reported outcomes using a cross-case comparison method and thematic synthesis. Results: We identified 19 Internet-based CBT programs in 59 documents. Of those, 71% (42/59) were of moderate to high quality. The PSD features surface credibility (competent “look and feel”), dialogue support (online program + in-person support), liking and similarity (esthetics and content appeal to adolescent users), the reduction and tunneling of therapeutic content (reducing online content into simple tasks, guiding users), and use of self-monitoring were present in therapies that resulted in improved therapy engagement, satisfaction, and adherence, as well as symptom and functional impairments. Conclusions: When incorporated into Internet-based CBT for adolescent depression, PSD features may improve adolescent adherence, satisfaction, and depression-related outcomes. Testing of these features using hypothesis-driven dismantling approaches is recommended to advance our understanding of how these features contribute to therapy effectiveness. %M 28793983 %R 10.2196/jmir.7573 %U http://www.jmir.org/2017/8/e266/ %U https://doi.org/10.2196/jmir.7573 %U http://www.ncbi.nlm.nih.gov/pubmed/28793983 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 8 %P e109 %T Usability Testing of the BRANCH Smartphone App Designed to Reduce Harmful Drinking in Young Adults %A Milward,Joanna %A Deluca,Paolo %A Drummond,Colin %A Watson,Rod %A Dunne,Jacklyn %A Kimergård,Andreas %+ Addictions Department, King's College London, 4 Windsor Walk, Denmark Hill, London, SE58BB, United Kingdom, 44 7590829898, joanna.milward@kcl.ac.uk %K alcohol %K drinking %K young adults %K mHealth %K brief intervention %K apps %K usability testing %K user experience %K focus group %D 2017 %7 08.08.2017 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Electronic screening and brief intervention (eSBI) apps demonstrate potential to reduce harmful drinking. However, low user engagement rates with eSBI reduce overall effectiveness of interventions. As “Digital Natives,” young adults have high expectations of app quality. Ensuring that the design, content, and functionality of an eSBI app are acceptable to young adults is an integral stage to the development process. Objective: The objective of this study was to identify usability barriers and enablers for an app, BRANCH, targeting harmful drinking in young adults. Methods: The BRANCH app contains a drinking diary, alcohol reduction goal setting functions, normative drinking feedback, and information on risks and advice for cutting down. The app includes a social feature personalized to motivate cutting down and to promote engagement with a point-based system for usage. Three focus groups were conducted with 20 users who had tested the app for 1 week. A detailed thematic analysis was undertaken. Results: The first theme, “Functionality” referred to how users wanted an easy-to-use interface, with minimum required user-input. Poor functionality was considered a major usability barrier. The second theme, “Design” described how an aesthetic with minimum text, clearly distinguishable tabs and buttons and appealing infographics was integral to the level of usability. The final theme, “Content” described how participants wanted all aspects of the app to be automatically personalized to them, as well as providing them with opportunities to personalize the app themselves, with increased options for social connectivity. Conclusions: There are high demands for apps such as BRANCH that target skilled technology users including young adults. Key areas to optimize eSBI app development that emerged from testing BRANCH with representative users include high-quality functionality, appealing aesthetics, and improved personalization. %M 28790022 %R 10.2196/mhealth.7836 %U http://mhealth.jmir.org/2017/8/e109/ %U https://doi.org/10.2196/mhealth.7836 %U http://www.ncbi.nlm.nih.gov/pubmed/28790022 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 8 %P e281 %T Behavior Change Techniques in Physical Activity eHealth Interventions for People With Cardiovascular Disease: Systematic Review %A Duff,Orlaith Mairead %A Walsh,Deirdre MJ %A Furlong,Bróna A %A O'Connor,Noel E %A Moran,Kieran A %A Woods,Catherine B %+ School of Health and Human Performance and Insight Centre for Data Analytics, Dublin City University, Room A246 (Albert College), School of Health and Human Performance, Dublin City University, Dublin, D9, Ireland, 353 1 700 ext 8011, kieran.moran@dcu.ie %K systematic review %K exercise %K behavior %K telemedicine %K cardiovascular disease %D 2017 %7 02.08.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Cardiovascular disease (CVD) is the leading cause of premature death and disability in Europe, accounting for 4 million deaths per year and costing the European Union economy almost €196 billion annually. There is strong evidence to suggest that exercise-based secondary rehabilitation programs can decrease the mortality risk and improve health among patients with CVD. Theory-informed use of behavior change techniques (BCTs) is important in the design of cardiac rehabilitation programs aimed at changing cardiovascular risk factors. Electronic health (eHealth) is the use of information and communication technologies (ICTs) for health. This emerging area of health care has the ability to enhance self-management of chronic disease by making health care more accessible, affordable, and available to the public. However, evidence-based information on the use of BCTs in eHealth interventions is limited, and particularly so, for individuals living with CVD. Objective: The aim of this systematic review was to assess the application of BCTs in eHealth interventions designed to increase physical activity (PA) in CVD populations. Methods: A total of 7 electronic databases, including EBSCOhost (MEDLINE, PsycINFO, Academic Search Complete, SPORTDiscus with Full Text, and CINAHL Complete), Scopus, and Web of Science (Core Collection) were searched. Two authors independently reviewed references using the software package Covidence (Veritas Health Innovation). The reviewers met to resolve any discrepancies, with a third independent reviewer acting as an arbitrator when required. Following this, data were extracted from the papers that met the inclusion criteria. Bias assessment of the studies was carried out using the Cochrane Collaboration’s tool for assessing the risk of bias within Covidence; this was followed by a narrative synthesis. Results: Out of the 987 studies that were identified, 14 were included in the review. An additional 9 studies were added following a hand search of review paper references. The average number of BCTs used across the 23 studies was 7.2 (range 1-19). The top three most frequently used BCTs included information about health consequences (78%, 18/23), goal setting (behavior; 74%, 17/23), and joint third, self-monitoring of behavior and social support (practical) were included in 11 studies (48%, 11/23) each. Conclusions: This systematic review is the first to investigate the use of BCTs in PA eHealth interventions specifically designed for people with CVD. This research will have clear implications for health care policy and research by outlining the BCTs used in eHealth interventions for chronic illnesses, in particular CVD, thereby providing clear foundations for further research and developments in the area. %M 28768610 %R 10.2196/jmir.7782 %U http://www.jmir.org/2017/8/e281/ %U https://doi.org/10.2196/jmir.7782 %U http://www.ncbi.nlm.nih.gov/pubmed/28768610 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 8 %P e277 %T Key Components in eHealth Interventions Combining Self-Tracking and Persuasive eCoaching to Promote a Healthier Lifestyle: A Scoping Review %A Lentferink,Aniek J %A Oldenhuis,Hilbrand KE %A de Groot,Martijn %A Polstra,Louis %A Velthuijsen,Hugo %A van Gemert-Pijnen,Julia EWC %+ Centre for eHealth & Wellbeing Research, Departement of Psychology, Health, and Technology, University of Twente, Cubicus Bldg, 10 De Zul, Enschede, 7522 NJ, Netherlands, 31 505956217, a.j.lentferink@utwente.nl %K telemedicine %K review %K health promotion %K remote sensing technology %D 2017 %7 01.08.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: The combination of self-tracking and persuasive eCoaching in automated interventions is a new and promising approach for healthy lifestyle management. Objective: The aim of this study was to identify key components of self-tracking and persuasive eCoaching in automated healthy lifestyle interventions that contribute to their effectiveness on health outcomes, usability, and adherence. A secondary aim was to identify the way in which these key components should be designed to contribute to improved health outcomes, usability, and adherence. Methods: The scoping review methodology proposed by Arskey and O’Malley was applied. Scopus, EMBASE, PsycINFO, and PubMed were searched for publications dated from January 1, 2013 to January 31, 2016 that included (1) self-tracking, (2) persuasive eCoaching, and (3) healthy lifestyle intervention. Results: The search resulted in 32 publications, 17 of which provided results regarding the effect on health outcomes, 27 of which provided results regarding usability, and 13 of which provided results regarding adherence. Among the 32 publications, 27 described an intervention. The most commonly applied persuasive eCoaching components in the described interventions were personalization (n=24), suggestion (n=19), goal-setting (n=17), simulation (n=17), and reminders (n=15). As for self-tracking components, most interventions utilized an accelerometer to measure steps (n=11). Furthermore, the medium through which the user could access the intervention was usually a mobile phone (n=10). The following key components and their specific design seem to influence both health outcomes and usability in a positive way: reduction by setting short-term goals to eventually reach long-term goals, personalization of goals, praise messages, reminders to input self-tracking data into the technology, use of validity-tested devices, integration of self-tracking and persuasive eCoaching, and provision of face-to-face instructions during implementation. In addition, health outcomes or usability were not negatively affected when more effort was requested from participants to input data into the technology. The data extracted from the included publications provided limited ability to identify key components for adherence. However, one key component was identified for both usability and adherence, namely the provision of personalized content. Conclusions: This scoping review provides a first overview of the key components in automated healthy lifestyle interventions combining self-tracking and persuasive eCoaching that can be utilized during the development of such interventions. Future studies should focus on the identification of key components for effects on adherence, as adherence is a prerequisite for an intervention to be effective. %M 28765103 %R 10.2196/jmir.7288 %U http://www.jmir.org/2017/8/e277/ %U https://doi.org/10.2196/jmir.7288 %U http://www.ncbi.nlm.nih.gov/pubmed/28765103 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 7 %P e263 %T Web-Based Interventions to Improve Mental Health, General Caregiving Outcomes, and General Health for Informal Caregivers of Adults With Chronic Conditions Living in the Community: Rapid Evidence Review %A Ploeg,Jenny %A Markle-Reid,Maureen %A Valaitis,Ruta %A McAiney,Carrie %A Duggleby,Wendy %A Bartholomew,Amy %A Sherifali,Diana %+ School of Nursing, Faculty of Health Sciences, McMaster University, Room HSc 3N25C, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada, 1 905 525 9140 ext 22294, ploegj@mcmaster.ca %K Internet %K review %K chronic disease %K adult %K caregivers %D 2017 %7 28.07.2017 %9 Review %J J Med Internet Res %G English %X Background: Most adults with chronic conditions live at home and rely on informal caregivers to provide support. Caregiving can result in negative impacts such as poor mental and physical health. eHealth interventions may offer effective and accessible ways to provide education and support to informal caregivers. However, we know little about the impact of Web-based interventions for informal caregivers of community-dwelling adults with chronic conditions. Objective: The purpose of this rapid evidence review was to assess the impact of Web-based interventions on mental health, general caregiving outcomes, and general health for informal caregivers of persons with chronic conditions living in the community. Methods: A rapid evidence review of the current literature was employed to address the study purpose. EMBASE, MEDLINE, PsychInfo, CINAHL, Cochrane, and Ageline were searched covering all studies published from January 1995 to July 2016. Papers were included if they (1) included a Web-based modality to deliver an intervention; (2) included informal, unpaid adult caregivers of community-living adults with a chronic condition; (3) were either a randomized controlled trial (RCT) or controlled clinical trial (CCT); and (4) reported on any caregiver outcome as a result of use or exposure to the intervention. Results: A total of 20 papers (17 studies) were included in this review. Study findings were mixed with both statistically significant and nonsignificant findings on various caregiver outcomes. Of the 17 included studies, 10 had at least one significant outcome. The most commonly assessed outcome was mental health, which included depressive symptoms, stress or distress, and anxiety. Twelve papers examined the impact of interventions on the outcome of depressive symptoms; 4 found a significant decrease in depressive symptoms. Eight studies examined the outcome of stress or distress; 4 of these found a significant reduction in stress or distress as a result of the intervention. Three studies examined the outcome of anxiety; 2 of these found significant reductions in anxiety. Other significant results of the interventions were seen in the outcomes of caregiver gain (ie, positive aspects of caregiving), knowledge, bonding, reduction of anger-hostility, and negative mood. Based on this review, it is not possible to determine which interventions were most effective since studies differed in their design, sample, and intervention. Study results suggest that Web-based interventions may result in reduced depressive symptoms, anxiety, and stress or distress among informal caregivers of adults with chronic conditions in the community. Conclusions: This is the first review assessing the impact of Web-based technologies on mental health, general caregiving outcomes, and general health for caregivers of adults with chronic conditions living in the community. Further rigorous research is needed that includes adequately powered studies examining the critical components of the intervention and the dosage needed to have an effect. %M 28754652 %R 10.2196/jmir.7564 %U http://www.jmir.org/2017/7/e263/ %U https://doi.org/10.2196/jmir.7564 %U http://www.ncbi.nlm.nih.gov/pubmed/28754652 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 7 %P e268 %T Personalized Web-Based Advice in Combination With Well-Child Visits to Prevent Overweight in Young Children: Cluster Randomized Controlled Trial %A van Grieken,Amy %A Vlasblom,Eline %A Wang,Lu %A Beltman,Maaike %A Boere-Boonekamp,Magda M %A L'Hoir,Monique P %A Raat,Hein %+ Erasmus University Medical Center, Department of Public Health, Dr. Molewaterplein 50, Rotterdam, 3000 CA, Netherlands, 31 107038580, h.raat@erasmusmc.nl %K healthy lifestyle %K child, preschool %K parenting %K child health %K intervention study %K eHealth %K randomized controlled trial %K body mass index %D 2017 %7 27.07.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Overweight is a major health issue, and parent-targeted interventions to promote healthy development in children are needed. Objective: The study aimed to evaluate E-health4Uth Healthy Toddler, an intervention that educates parents of children aged 18 to 24 months regarding health-related behaviors, as compared with usual care. The effect of this intervention on the following primary outcomes was evaluated when the children were 36 months of age: health-related behaviors (breakfast daily, activity and outside play, sweetened beverage consumption, television (TV) viewing and computer time), body mass index (BMI), and the prevalence of overweight and obesity. Methods: The BeeBOFT (acronym for breastfeeding, breakfast daily, outside playing, few sweet drinks, less TV viewing) study is a cluster randomized controlled trial involving 51 Youth Health Care (YHC) teams. In total, 1094 parents participated in the control group, and 1008 parents participated in the E-health4Uth Healthy Toddler intervention group. The intervention consisted of Web-based personalized advice given to parents who completed an eHealth module and discussion of the advice during a regular well-child visit. In this study the eHealth module was offered to parents before two regular well-child visits at 18 and 24 months of age. During the well-child visits, the parents’ personalized advice was combined with face-to-face counseling provided by the YHC professional. Parents in the control group received usual care, consisting of the regular well-child visits during which general information on child health-related behavior was provided to parents. Parents completed questionnaires regarding family characteristics and health-related behaviors when the child was 1 month (inclusion), 6 months, 14 months, and 36 months (follow-up) of age. The child’s height and weight were measured by trained health care professionals from birth through 36 months of age at fixed time points. Multilevel linear and logistic regression models were used to evaluate the primary outcomes at 36 months of age. Results: At 36 months, we observed no differences between health-related behaviors of children, BMI or the percentage of children having overweight or obesity in the control and intervention group (P>.05). An analysis of the intervention effect revealed that boys benefited from eating breakfast daily, non-Dutch children spent more time being active or playing outdoors, children of low-educated parents and of overweight and obese mothers spent less time watching TV or using the computer, and children of normal weight mothers drank less sweetened beverages (P<.05) compared with the control group. Conclusions: The E-health4Uth Healthy Toddler intervention resulted in small improvements in health-related behaviors among subgroups but had no significant effects with respect to the children’s BMI. We conclude that the E-health4Uth Healthy Toddler intervention may be useful for pediatric health care professionals in terms of providing parents with personalized information regarding their child’s health-related behaviors. Trial Registration: Netherlands Trial Register: NTR1831; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1831 (Archived by WebCite at http://www.webcitation.org/6mm5YFOB0) %M 28751299 %R 10.2196/jmir.7115 %U http://www.jmir.org/2017/7/e268/ %U https://doi.org/10.2196/jmir.7115 %U http://www.ncbi.nlm.nih.gov/pubmed/28751299 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 7 %P e273 %T Twelve-Month Follow-Up of a Randomized Controlled Trial of Internet-Based Guided Self-Help for Parents of Children on Cancer Treatment %A Cernvall,Martin %A Carlbring,Per %A Wikman,Anna %A Ljungman,Lisa %A Ljungman,Gustaf %A von Essen,Louise %+ Clinical Psychology in Healthcare, Department of Women’s and Children’s Health, Uppsala University, Biomedicinskt Centrum, Box 572, Uppsala, 75122, Sweden, 46 709564480, martin.cernvall@kbh.uu.se %K cancer %K parents %K Internet %K PTSS %K depression %K anxiety %K clinical trial %D 2017 %7 27.07.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: A substantial proportion of parents of children on cancer treatment report psychological distress such as symptoms of post-traumatic stress (PTSS), depression, and anxiety. During their child’s treatment many parents also experience an economic burden. Objective: The aim of this study was to evaluate the long-term efficacy of Internet-based guided self-help for parents of children on cancer treatment. Methods: This study was a parallel randomized controlled trial comparing a 10-week Internet-based guided self-help program, including weekly support from a therapist via encrypted email, with a wait-list control condition. The intervention was based on cognitive behavior therapy (CBT) and focused on psychoeducation and skills to cope with difficult thoughts and feelings. Primary outcome was self-reported PTSS. Secondary outcomes were self-reported symptoms of depression, anxiety, health care consumption, and sick leave during the past month. Outcomes were assessed pre- and postintervention and at 12-month follow-up. Parents of children on cancer treatment were invited by health care personnel at pediatric oncology centers, and parents meeting the modified symptom criteria on the PCL-C were included in the study. Self-report assessments were provided on the Web. Results: A total of 58 parents of children on cancer treatment (median months since diagnosis=3) were included in the study (intervention n=31 and control n=27). A total of 18 participants completed the intervention, and 16 participants in each group participated in the 12-month follow-up. Intention-to-treat analyses revealed significant effects in favor of the intervention on the primary outcome PTSS, with large between-group effect sizes at postassessment (d=0.89; 95% CI 0.35-1.43) and at 12-month follow-up (d=0.78; 95% CI 0.25-1.32). Significant effects in favor of the intervention on the secondary outcomes depression and anxiety were also observed. However, there was no evidence for intervention efficacy on health care consumption or sick leave. Conclusions: Using the Internet to provide psychological interventions shows promise as an effective mode of delivery for parents reporting an increased level of PTSS and who consider Internet-based interventions as a viable option. Future research should corroborate these findings and also develop and evaluate interventions and policies that may help ameliorate the economic burden that parents may face during their child’s treatment for cancer. %M 28751300 %R 10.2196/jmir.6852 %U http://www.jmir.org/2017/7/e273/ %U https://doi.org/10.2196/jmir.6852 %U http://www.ncbi.nlm.nih.gov/pubmed/28751300 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 7 %P e271 %T Improving Employee Well-Being and Effectiveness: Systematic Review and Meta-Analysis of Web-Based Psychological Interventions Delivered in the Workplace %A Carolan,Stephany %A Harris,Peter R %A Cavanagh,Kate %+ School of Psychology, University of Sussex, Falmer, Brighton, BN1 9QH, United Kingdom, 44 (0)1273 876638, sc587@sussex.ac.uk %K adherence %K engagement %K Internet %K meta-analysis %K psychological interventions %K stress %K systematic review %K wellbeing %K workplace %D 2017 %7 26.07.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Stress, depression, and anxiety among working populations can result in reduced work performance and increased absenteeism. Although there is evidence that these common mental health problems are preventable and treatable in the workplace, uptake of psychological treatments among the working population is low. One way to address this may be the delivery of occupational digital mental health interventions. While there is convincing evidence for delivering digital psychological interventions within a health and community context, there is no systematic review or meta-analysis of these interventions in an occupational setting. Objective: The aim of this study was to identify the effectiveness of occupational digital mental health interventions in enhancing employee psychological well-being and increasing work effectiveness and to identify intervention features associated with the highest rates of engagement and adherence. Methods: A systematic review of the literature was conducted using Cochrane guidelines. Papers published from January 2000 to May 2016 were searched in the PsychINFO, MEDLINE, PubMed, Science Direct, and the Cochrane databases, as well as the databases of the researchers and relevant websites. Unpublished data was sought using the Conference Proceedings Citation Index and the Clinical Trials and International Standard Randomized Controlled Trial Number (ISRCTN) research registers. A meta-analysis was conducted by applying a random-effects model to assess the pooled effect size for psychological well-being and the work effectiveness outcomes. A positive deviance approach was used to identify those intervention features associated with the highest rates of engagement and adherence. Results: In total, 21 randomized controlled trials (RCTs) met the search criteria. Occupational digital mental health interventions had a statistically significant effect post intervention on both psychological well-being (g=0.37, 95% CI 0.23-0.50) and work effectiveness (g=0.25, 95% CI 0.09-0.41) compared with the control condition. No statistically significant differences were found on either outcome between studies using cognitive behavioral therapy (CBT) approaches (as defined by the authors) compared with other psychological approaches, offering guidance compared with self-guidance, or recruiting from a targeted workplace population compared with a universal workplace population. In-depth analysis of the interventions identified by the positive deviance approach suggests that interventions that offer guidance are delivered over a shorter time frame (6 to 7 weeks), utilize secondary modalities for delivering the interventions and engaging users (ie, emails and text messages [short message service, SMS]), and use elements of persuasive technology (ie, self-monitoring and tailoring), which may achieve greater engagement and adherence. Conclusions: This review provides evidence that occupational digital mental health interventions can improve workers’ psychological well-being and increase work effectiveness. It identifies intervention characteristics that may increase engagement. Recommendations are made for future research, practice, and intervention development. %M 28747293 %R 10.2196/jmir.7583 %U http://www.jmir.org/2017/7/e271/ %U https://doi.org/10.2196/jmir.7583 %U http://www.ncbi.nlm.nih.gov/pubmed/28747293 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 7 %P e258 %T Nurse-Moderated Internet-Based Support for New Mothers: Non-Inferiority, Randomized Controlled Trial %A Sawyer,Michael G %A Reece,Christy E %A Bowering,Kerrie %A Jeffs,Debra %A Sawyer,Alyssa C P %A Mittinty,Murthy %A Lynch,John W %+ Research and Evaluation Unit, Women's and Children's Health Network, 72 King William Road, Adelaide, 5006, Australia, 61 881617207, michael.sawyer@adelaide.edu.au %K public health informatics %K community health services %K Internet %D 2017 %7 24.07.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-based interventions moderated by community nurses have the potential to improve support offered to new mothers, many of whom now make extensive use of the Internet to obtain information about infant care. However, evidence from population-based randomized controlled trials is lacking. Objective: The aim of this study was to test the non-inferiority of outcomes for mothers and infants who received a clinic-based postnatal health check plus nurse-moderated, Internet-based group support when infants were aged 1-7 months as compared with outcomes for those who received standard care consisting of postnatal home-based support provided by a community nurse. Methods: The design of the study was a pragmatic, preference, non-inferiority randomized control trial. Participants were recruited from mothers contacted for their postnatal health check, which is offered to all mothers in South Australia. Mothers were assigned either (1) on the basis of their preference to clinic+Internet or home-based support groups (n=328), or (2) randomly assigned to clinic+Internet or home-based groups if they declared no strong preference (n=491). The overall response rate was 44.8% (819/1827). The primary outcome was parenting self-competence, as measured by the Parenting Stress Index (PSI) Competence subscale, and the Karitane Parenting Confidence Scale scores. Secondary outcome measures included PSI Isolation, Interpersonal Support Evaluation List–Short Form, Maternal Support Scale, Ages and Stages Questionnaire–Social-Emotional and MacArthur Communicative Development Inventory (MCDI) scores. Assessments were completed offline via self-assessment questionnaires at enrolment (mean child age=4.1 weeks, SD 1.3) and again when infants were aged 9, 15, and 21 months. Results: Generalized estimating equations adjusting for post-randomization baseline imbalances showed that differences in outcomes between mothers in the clinic+Internet and home-based support groups did not exceed the pre-specified margin of inferiority (0.25 of a SD) on any outcome measure at any follow-up assessment, with the exception of MCDI scores assessing children’s language development at 21 months for randomized mothers, and PSI Isolation scores at 9 months for preference mothers. Conclusion: Maternal and child outcomes from a clinic-based postnatal health check plus nurse-moderated Internet-based support were not inferior to those achieved by a universal home-based postnatal support program. Postnatal maternal and infant support using the Internet is a promising alternative to home-based universal support programs. Trial Registration: Australian New Zealand Clinical Trials Registry Number (ANZCTR): ACTRN12613000204741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363712&isReview=true (Archived by WebCite at http://www.webcitation.org/6rZeCJ3k1) %M 28739559 %R 10.2196/jmir.6839 %U http://www.jmir.org/2017/7/e258/ %U https://doi.org/10.2196/jmir.6839 %U http://www.ncbi.nlm.nih.gov/pubmed/28739559 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 7 %P e264 %T Evaluating a Web-Based Coaching Program Using Electronic Health Records for Patients With Chronic Obstructive Pulmonary Disease in China: Randomized Controlled Trial %A Wang,Lan %A He,Lin %A Tao,Yanxia %A Sun,Li %A Zheng,Hong %A Zheng,Yashu %A Shen,Yuehao %A Liu,Suyan %A Zhao,Yue %A Wang,Yaogang %+ Health Service Management, School of Public Health, Tianjin Medical University, 22 Qixiangtai Rd, Tianjin,, China, 86 022 83336636, wyg@tmu.edu.cn %K chronic obstructive pulmonary disease %K electronic health records %K Web-based coaching program %D 2017 %7 21.07.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic obstructive pulmonary disease (COPD) is now the fourth leading cause of death in the world, and it continues to increase in developing countries. The World Health Organization expects COPD to be the third most common cause of death in the world by 2020. Effective and continuous postdischarge care can help patients to maintain good health. The use of electronic health records (EHRs) as an element of community health care is new technology in China. Objective: The aim of this study was to develop and evaluate a Web-based coaching program using EHRs for physical function and health-related quality of life for patients with COPD in China. Methods: A randomized controlled trial was conducted from 2008 to 2015 at two hospitals. The control group received routine care and the intervention group received routine care with the addition of the Web-based coaching program using EHRs. These were used to manage patients’ demographic and clinical variables, publish relevant information, and have communication between patients and health care providers. Participants were not blinded to group assignment. The effects of the intervention were evaluated by lung function, including percent of forced expiratory volume in 1 second (FEV1%), percent of forced vital capacity (FVC%), peak expiratory flow (PEF), maximum midexpiratory flow; St George’s Respiratory Questionnaire (SGRQ); Modified Medical Research Council Dyspnea Scale (MMRC); and 6-Minute Walk Test (6MWT). Data were collected before the program, and at 1, 3, 6, and 12 months after the program. Results: Of the 130 participants, 120 (92.3%) completed the 12-month follow-up program. There were statistically significant differences in lung function (FEV1%: F1,4=5.47, P=.002; FVC%: F1,4=3.06, P=.02; PEF: F1,4=12.49, P<.001), the total score of SGRQ (F1,4=23.30, P<.001), symptoms of SGRQ (F1,4=12.38, P<.001), the activity of SGRQ (F1,4=8.35, P<.001), the impact of SGRQ (F1,4=12.26, P<.001), MMRC (F1,4=47.94, P<.001), and 6MWT (F1,4=35.54, P<.001) between the two groups with the variation of time tendency. Conclusions: The Web-based coaching program using EHRs in China appears to be useful for patients with COPD when they are discharged from hospital into the community. It promotes the sharing of patients’ medical information by hospital and community nurses, and achieves dynamic management and follow-up analysis for patients’ disease. In addition, this program can postpone the decreasing rate of lung function, improve quality of life, decrease dyspnea, and increase physical capacity. %M 28733270 %R 10.2196/jmir.6743 %U http://www.jmir.org/2017/7/e264/ %U https://doi.org/10.2196/jmir.6743 %U http://www.ncbi.nlm.nih.gov/pubmed/28733270 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 7 %P e256 %T Development and Use of Health-Related Technologies in Indigenous Communities: Critical Review %A Jones,Louise %A Jacklin,Kristen %A O'Connell,Megan E %+ Centre for Rural and Northern Health Research, Laurentian University, 935 Ramsey Lake Rd, Sudbury, ON, P3E 2C6, Canada, 1 705 675 1151 ext 4171, lajones@laurentian.ca %K Indians, North American %K Canada %K telemedicine %K self-help devices %K needs assessment %K aging %D 2017 %7 20.07.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Older Indigenous adults encounter multiple challenges as their age intersects with health inequities. Research suggests that a majority of older Indigenous adults prefer to age in place, and they will need culturally safe assistive technologies to do so. Objective: The aim of this critical review was to examine literature concerning use, adaptation, and development of assistive technologies for health purposes by Indigenous peoples. Methods: Working within Indigenous research methodologies and from a decolonizing approach, searches of peer-reviewed academic and gray literature dated to February 2016 were conducted using keywords related to assistive technology and Indigenous peoples. Sources were reviewed and coded thematically. Results: Of the 34 sources captured, only 2 concerned technology specifically for older Indigenous adults. Studies detailing technology with Indigenous populations of all ages originated primarily from Canada (n=12), Australia (n=10), and the United States (n=9) and were coded to four themes: meaningful user involvement and community-based processes in development, the digital divide, Indigenous innovation in technology, and health technology needs as holistic and interdependent. Conclusions: A key finding is the necessity of meaningful user involvement in technology development, especially in communities struggling with the digital divide. In spite of, or perhaps because of this divide, Indigenous communities are enthusiastically adapting mobile technologies to suit their needs in creative, culturally specific ways. This enthusiasm and creativity, coupled with the extensive experience many Indigenous communities have with telehealth technologies, presents opportunity for meaningful, culturally safe development processes. %M 28729237 %R 10.2196/jmir.7520 %U http://www.jmir.org/2017/7/e256/ %U https://doi.org/10.2196/jmir.7520 %U http://www.ncbi.nlm.nih.gov/pubmed/28729237 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 7 %P e261 %T Adolescents’ Perspectives on Personalized E-Feedback in the Context of Health Risk Behavior Screening for Primary Care: Qualitative Study %A Zieve,Garret G %A Richardson,Laura P %A Katzman,Katherine %A Spielvogle,Heather %A Whitehouse,Sandy %A McCarty,Carolyn A %+ Center for Child Health, Behavior and Development, Seattle Children’s Research Institute, 2001 8th Ave #400, Seattle, WA, 98121, United States, 1 206 884 7800, cari.mccarty@seattlechildrens.org %K adolescent %K screening %K health behavior %K motivation %K primary health care %K software %K technology %K qualitative research %D 2017 %7 20.07.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Electronic health screening tools for primary care present an opportunity to go beyond data collection to provide education and feedback to adolescents in order to motivate behavior change. However, there is limited research to guide feedback message development. Objective: The aim of this study was to explore youth perceptions of and preferences for receiving personalized feedback for multiple health risk behaviors and reinforcement for health promoting behaviors from an electronic health screening tool for primary care settings, using qualitative methodology. Methods: In total, 31 adolescents aged 13-18 years completed the screening tool, received the electronic feedback, and subsequently participated in individual, semistructured, qualitative interviews lasting approximately 60 min. Participants were queried about their overall impressions of the tool, perceptions regarding various types of feedback messages, and additional features that would help motivate health behavior change. Using thematic analysis, interview transcripts were coded to identify common themes expressed across participants. Results: Overall, the tool was well-received by participants who perceived it as a way to enhance—but not replace—their interactions with providers. They appreciated receiving nonjudgmental feedback from the tool and responded positively to information regarding the consequences of behaviors, comparisons with peer norms and health guidelines, tips for behavior change, and reinforcement of healthy choices. A small but noteworthy minority of participants dismissed the peer norms as not real or relevant and national guidelines as not valid or reasonable. When prompted for possible adaptations to the tool, adolescents expressed interest in receiving follow-up information, setting health-related goals, tracking their behaviors over time, and communicating with providers electronically between appointments. Conclusions: Adolescents in this qualitative study desired feedback that validates their healthy behavior choices and supports them as independent decision makers by neutrally presenting health information, facilitating goal setting, and offering ongoing technological supports. %M 28729236 %R 10.2196/jmir.7474 %U http://www.jmir.org/2017/7/e261/ %U https://doi.org/10.2196/jmir.7474 %U http://www.ncbi.nlm.nih.gov/pubmed/28729236 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 7 %P e245 %T Short Text Messages to Encourage Adherence to Medication and Follow-up for People With Psychosis (Mobile.Net): Randomized Controlled Trial in Finland %A Välimäki,Maritta %A Kannisto,Kati Anneli %A Vahlberg,Tero %A Hätönen,Heli %A Adams,Clive E %+ Department of Nursing Science, Joukahaisenkatu 3-5, University of Turku, 20014, Turku,, Finland, 358 40 5599235, mava@utu.fi %K text messaging %K psychotic disorders %K randomized controlled trial %K medication adherence %D 2017 %7 12.07.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: A text messaging service (short message service [SMS]) has the potential to target large groups of people with long-term illnesses such as serious mental disorders, who may have difficulty with treatment adherence. Robust research on the impact of mobile technology interventions for these patients remains scarce. Objective: The main objective of our study was to investigate the impact of individually tailored short text messages on the rate of psychiatric hospital readmissions, health care service use, and clinical outcomes. In addition, we analyzed treatment costs. Methods: Between September 2011 and November 2012, we randomly assigned 1139 people to a tailored text message intervention (n=569) or usual care (n=570). Participants received semiautomated text messages for up to 12 months or usual care. The primary outcome, based on routinely collected health register data, was patient readmission into a psychiatric hospital during a 12-month follow-up period. Secondary outcomes were related to other service use, coercion, medication, adverse events, satisfaction, social functioning, quality of life, and economic factors (cost analysis). Results: There was 98.24% (1119/1139) follow-up at 12 months. Tailored mobile telephone text messages did not reduce the rate of hospital admissions (242/563, 43.0% of the SMS group vs 216/556, 38.8% of the control group; relative risk 1.11; 95% CI 0.92-1.33; P=.28), time between hospitalizations (mean difference 7.0 days 95% CI –8.0 to 24.0; P=.37), time spent in a psychiatric hospital during the year (mean difference 2.0 days 95% CI –2.0 to 7.0; P=.35), or other service outcomes. People who received text messages were less disabled, based on Global Assessment Scale scores at the time of their readmission, than those who did not receive text messages (odds ratio 0.68; 95% CI 0.47-0.97; P=.04). The costs of treatment were higher for people in the SMS group than in the control group (mean €10,103 vs €9210, respectively, P<.001). Conclusions: High-grade routinely collected data can provide clear outcomes for pragmatic randomized trials. SMS messaging tailored with the input of each individual patient did not decrease the rate of psychiatric hospital visits after the 12 months of follow-up. Although there may have been other, more subtle effects, the results of these were not evident in outcomes of agreed importance to clinicians, policymakers, and patients and their families. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 27704027; http://www.isrctn.com/ISRCTN27704027 (Archived by WebCite at http://www.webcitation.org/6rVzZrbuz). %M 28701292 %R 10.2196/jmir.7028 %U http://www.jmir.org/2017/7/e245/ %U https://doi.org/10.2196/jmir.7028 %U http://www.ncbi.nlm.nih.gov/pubmed/28701292 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 7 %P e247 %T Using New and Emerging Technologies to Identify and Respond to Suicidality Among Help-Seeking Young People: A Cross-Sectional Study %A Iorfino,Frank %A Davenport,Tracey A %A Ospina-Pinillos,Laura %A Hermens,Daniel F %A Cross,Shane %A Burns,Jane %A Hickie,Ian B %+ Brain and Mind Centre, The University of Sydney, 94 Mallett St, Camperdown, Sydney, 2050, Australia, 61 02 9351 0827, frank.iorfino@sydney.edu.au %K suicidal ideation %K mental health %K primary health care %K telemedicine %K health services %D 2017 %7 12.07.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Suicidal thoughts are common among young people presenting to face-to-face and online mental health services. The early detection and rapid response to these suicidal thoughts and other suicidal behaviors is a priority for suicide prevention and early intervention efforts internationally. Establishing how best to use new and emerging technologies to facilitate person-centered systematic assessment and early intervention for suicidality is crucial to these efforts. Objective: The aim of this study was to examine the use of a suicidality escalation protocol to respond to suicidality among help-seeking young people. Methods: A total of 232 young people in the age range of 16-25 years were recruited from either a primary mental health care service or online in the community. Each young person used the Synergy Online System and completed an initial clinical assessment online before their face-to-face or online clinical appointment. A suicidality escalation protocol was used to identify and respond to current and previous suicidal thoughts and behaviors. Results: A total of 153 young people (66%, 153/232) reported some degree of suicidality and were provided with a real-time alert online. Further levels of escalation (email or phone contact and clinical review) were initiated for the 35 young people (15%, 35/232) reporting high suicidality. Higher levels of psychological distress (P<.001) and a current alcohol or substance use problem (P=.02) predicted any level of suicidality compared with no suicidality. Furthermore, predictors of high suicidality compared with low suicidality were higher levels of psychological distress (P=.01), psychosis-like symptoms in the last 12 months (P=.01), a previous mental health problem (P=.01), and a history of suicide planning or attempts (P=.001). Conclusions: This study demonstrates the use of new and emerging technologies to facilitate the systematic assessment and detection of help-seeking young people presenting with suicidality. This protocol empowered the young person by suggesting pathways to care that were based on their current needs. The protocol also enabled an appropriate and timely response from service providers for young people reporting high suicidality that was associated with additional comorbid issues, including psychosis-like symptoms, and a history of suicide plans and attempts. %M 28701290 %R 10.2196/jmir.7897 %U http://www.jmir.org/2017/7/e247/ %U https://doi.org/10.2196/jmir.7897 %U http://www.ncbi.nlm.nih.gov/pubmed/28701290 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 7 %P e246 %T Effectiveness of Digital Medicines to Improve Clinical Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial %A Frias,Juan %A Virdi,Naunihal %A Raja,Praveen %A Kim,Yoona %A Savage,George %A Osterberg,Lars %+ Proteus Digital Health, 2600 Bridge Parkway, Redwood City, CA, 94065, United States, 1 4158285009, nvirdi@proteus.com %K digital medicine %K hypertension %K type 2 diabetes %K patient engagement, medication adherence %K therapeutic inertia %D 2017 %7 11.07.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Hypertension and type 2 diabetes mellitus are major modifiable risk factors for cardiac, cerebrovascular, and kidney diseases. Reasons for poor disease control include nonadherence, lack of patient engagement, and therapeutic inertia. Objective: The aim of this study was to assess the impact on clinic-measured blood pressure (BP) and glycated hemoglobin (HbA1c) using a digital medicine offering (DMO) that measures medication ingestion adherence, physical activity, and rest using digital medicines (medication taken with ingestible sensor), wearable sensor patches, and a mobile device app. Methods: Participants with elevated systolic BP (SBP ≥140 mm Hg) and HbA1c (≥7%) failing antihypertensive (≥2 medications) and oral diabetes therapy were enrolled in this three-arm, 12-week, cluster-randomized study. Participants used DMO (includes digital medicines, the wearable sensor patch, and the mobile device app) for 4 or 12 weeks or received usual care based on site randomization. Providers in the DMO arms could review the DMO data via a Web portal. In all three arms, providers were instructed to make medical decisions (medication titration, adherence counseling, education, and lifestyle coaching) on all available clinical information at each visit. Primary outcome was change in SBP at week 4. Other outcomes included change in SBP and HbA1c at week 12, and low-density lipoprotein cholesterol (LDL-C) and diastolic blood pressure (DBP) at weeks 4 and 12, as well as proportion of patients at BP goal (<140/90 mm Hg) at weeks 4 and 12, medical decisions, and medication adherence patterns. Results: Final analysis included 109 participants (12 sites; age: mean 58.7, SD years; female: 49.5%, 54/109; Hispanic: 45.9%, 50/109; income ≤ US $20,000: 56.9%, 62/109; and ≤ high school education: 52.3%, 57/109). The DMO groups had 80 participants (7 sites) and usual care had 29 participants (5 sites). At week 4, DMO resulted in a statistically greater SBP reduction than usual care (mean –21.8, SE 1.5 mm Hg vs mean –12.7, SE 2.8 mmHg; mean difference –9.1, 95% CI –14.0 to –3.3 mm Hg) and maintained a greater reduction at week 12. The DMO groups had greater reductions in HbA1c, DBP, and LDL-C, and a greater proportion of participants at BP goal at weeks 4 and 12 compared with usual care. The DMO groups also received more therapeutic interventions than usual care. Medication adherence was ≥80% while using the DMO. The most common adverse event was a self-limited rash at the wearable sensor site (12%, 10/82). Conclusions: For patients failing hypertension and diabetes oral therapy, this DMO, which provides dose-by-dose feedback on medication ingestion adherence, can help lower BP, HbA1c, and LDL-C, and promote patient engagement and provider decision making. Trial Registration: Clinicaltrials.gov NCT02827630; https://clinicaltrials.gov/show/NCT02827630 (Archived by WebCite at http://www.webcitation.org/6rL8dW2VF) %M 28698169 %R 10.2196/jmir.7833 %U http://www.jmir.org/2017/7/e246/ %U https://doi.org/10.2196/jmir.7833 %U http://www.ncbi.nlm.nih.gov/pubmed/28698169 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 7 %P e234 %T Use of a Connected Glucose Meter and Certified Diabetes Educator Coaching to Decrease the Likelihood of Abnormal Blood Glucose Excursions: The Livongo for Diabetes Program %A Downing,Janelle %A Bollyky,Jenna %A Schneider,Jennifer %+ Livongo Health, 150 W Evelyn Ave #150, Mountain View, CA, 94041, United States, 1 206 403 8450, jbollyky@livongo.com %K SMBG %K blood glucose self-monitoring %K diabetes remote monitoring %K diabetes management %K diabetes mellitus %K self-care %D 2017 %7 11.07.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: The Livongo for Diabetes Program offers members (1) a cellular technology-enabled, two-way messaging device that measures blood glucose (BG), centrally stores the glucose data, and delivers messages back to the individual in real time; (2) unlimited BG test strips; and (3) access to a diabetes coaching team for questions, goal setting, and automated support for abnormal glucose excursions. The program is sponsored by at-risk self-insured employers, health plans and provider organizations where it is free to members with diabetes or it is available directly to the person with diabetes where they cover the cost. Objective: The objective of our study was to evaluate BG data from 4544 individuals with diabetes who were enrolled in the Livongo program from October 2014 through December 2015. Methods: Members used the Livongo glucose meter to measure their BG levels an average of 1.8 times per day. We estimated the probability of having a day with a BG reading outside of the normal range (70-180 mg/dL, or 3.9-10.0 mmol/L) in months 2 to 12 compared with month 1 of the program, using individual fixed effects to control for individual characteristics. Results: Livongo members experienced an average 18.4% decrease in the likelihood of having a day with hypoglycemia (BG <70 mg/dL) and an average 16.4% decrease in hyperglycemia (BG >180 mg/dL) in months 2-12 compared with month 1 as the baseline. The biggest impact was seen on hyperglycemia for nonusers of insulin. We do not know all of the contributing factors such as medication or other treatment changes during the study period. Conclusions: These findings suggest that access to a connected glucose meter and certified diabetes educator coaching is associated with a decrease in the likelihood of abnormal glucose excursions, which can lead to diabetes-related health care savings. %M 28698167 %R 10.2196/jmir.6659 %U http://www.jmir.org/2017/7/e234/ %U https://doi.org/10.2196/jmir.6659 %U http://www.ncbi.nlm.nih.gov/pubmed/28698167 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 7 %P e241 %T A Self-Regulation-Based eHealth Intervention to Promote a Healthy Lifestyle: Investigating User and Website Characteristics Related to Attrition %A Van der Mispel,Celien %A Poppe,Louise %A Crombez,Geert %A Verloigne,Maïté %A De Bourdeaudhuij,Ilse %+ Research Group Physical Activity and Health, Department of Movement and Sports Sciences, Ghent University, Watersportlaan 2, Ghent, 9000, Belgium, 32 9264 63 63, celien.vandermispel@ugent.be %K physical activity %K healthy diet %K eHealth %K attrition %K self-regulation %D 2017 %7 11.07.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: eHealth interventions can reach large populations and are effective in increasing physical activity (PA) and fruit and vegetable intake. Nevertheless, the effects of eHealth interventions are overshadowed by high attrition rates. Examining more closely when users decide to leave the intervention can help eHealth developers to make informed decisions about which intervention components should be reshaped or simply removed. Investigating which users are more likely to quit an intervention can inform developers about whether and how their intervention should be adapted to specific subgroups of users. Objective: This study investigated the pattern of attrition in a Web-based intervention to increase PA, fruit, and vegetable intake. The first aim was to describe attrition rates according to different self-regulation components. A second aim was to investigate whether certain user characteristics are predictors for start session completion, returning to a follow-up session and intervention completion. Methods: The sample consisted of 549 adults who participated in an online intervention, based on self-regulation theory, to promote PA and fruit and vegetable intake, called “MyPlan 1.0.” Using descriptive analysis, attrition was explored per self-regulation component (eg, action planning and coping planning). To identify which user characteristics predict completion, logistic regression analyses were conducted. Results: At the end of the intervention program, there was an attrition rate of 78.2% (330/422). Attrition rates were very similar for the different self-regulation components. However, attrition levels were higher for the fulfillment of questionnaires (eg, to generate tailored feedback) than for the more interactive components. The highest amount of attrition could be observed when people were asked to make their own action plan. There were no significant predictors for first session completion. Yet, two subgroups had a lower chance to complete the intervention, namely male users (OR: 2.24, 95% CI=1.23-4.08) and younger adults (OR: 1.02, 95% CI=1.00-1.04). Furthermore, younger adults were less likely to return to the website for the first follow-up after one week (OR: 1.03, 95% CI=1.01-1.04). Conclusions: This study informs us that eHealth interventions should avoid the use of extensive questionnaires and that users should be provided with a rationale for several components (eg, making an action plan and completing questions). Furthermore, future interventions should focus first on motivating users for the behavior change before guiding them through action planning. Though, this study provides no evidence for removal of one of the self-regulation techniques based on attrition rates. Finally, strong efforts are needed to motivate male users and younger adults to complete eHealth interventions. %M 28698168 %R 10.2196/jmir.7277 %U http://www.jmir.org/2017/7/e241/ %U https://doi.org/10.2196/jmir.7277 %U http://www.ncbi.nlm.nih.gov/pubmed/28698168 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 2 %N 2 %P e14 %T Web-Based Weight Loss Intervention for Men With Type 2 Diabetes: Pilot Randomized Controlled Trial %A Haste,Anna %A Adamson,Ashley J %A McColl,Elaine %A Araujo-Soares,Vera %A Bell,Ruth %+ Institute of Health and Society, Faculty of Medical Sciences, Newcastle University, Baddiley Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, United Kingdom, 44 0 191 208 7045, anna.haste@newcastle.ac.uk %K weight loss %K Web-based intervention %K feasibility studies %K pilot RCT %K randomized controlled trial %K pilot projects %K type 2 diabetes %K diabetes mellitus, type 2 %K men %K men's health %K process evaluation %D 2017 %7 07.07.2017 %9 Original Paper %J JMIR Diabetes %G English %X Background: Rising obesity levels remain a major public health concern due to the clear link with several comorbidities such as diabetes. Diabetes now affects 6% of the UK population. Modest weight loss of 5% to 10% has been shown to be associated with significant reductions in blood sugar, lipid, and blood pressure levels. Men have been shown to be attracted to programs that do not require extensive face-to-face time commitments, illustrating the potential audience available for health behavior change via the Web. Objective: The objective of our study was to evaluate the feasibility and acceptability of a Web-based weight loss intervention in men with type 2 diabetes. Methods: We conducted a pilot, parallel 2-arm, individually randomized controlled trial with embedded process evaluation. Participants were randomly assigned in a one-to-one ratio to the usual care group or the 12-month Web-based weight loss intervention, including dietitian and exercise expert feedback. Face-to-face recruitment and assessment were performed by the researcher unblinded. Data collected included weight, height, body mass index (BMI), and waist circumference, together with an audit trail of eligibility, recruitment, retention, and adherence rates. A process evaluation (website use data and qualitative interviews) monitored adherence, acceptability, and feasibility of the intervention. Results: General practice database searches achieved the recruitment target (n=61) for the population of men with type 2 diabetes, of whom 66% (40/61) completed 3-month follow-up measurements. By 12 months, the retention rate was 52% (32/61), with 12 of the 33 men allocated to the intervention group still active on the website. The intervention was seen as acceptable by the majority of participants. We gained insights about acceptability and use of the website from the parallel process evaluation. Conclusions: Recruitment to the Web-based weight loss intervention was successful. Results are descriptive, but there were positive indications of increased weight loss (in kilograms and as a percentage), and reduced waist circumference and BMI for the intervention group from 3 to 12 months, in comparison with control. This research adds to the evidence base in relation to incorporating a Web-based weight loss intervention within the UK National Health Service (NHS). NHS weight loss services are struggling to provide sufficient referrals. Therefore, alternative modes of delivery, with the potential to reduce health professional input and time per patient while still enabling individual and tailored care, need to be investigated to identify whether they can be effective and thus benefit the NHS. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 48086713; http://www.isrctn.com/ISRCTN48086713 (Archived by WebCite at http://www.webcitation.org/6rO4xSlhI) %M 30291100 %R 10.2196/diabetes.7430 %U http://diabetes.jmir.org/2017/2/e14/ %U https://doi.org/10.2196/diabetes.7430 %U http://www.ncbi.nlm.nih.gov/pubmed/30291100 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 7 %P e242 %T Preventing Prescription Drug Misuse in Work Settings: Efficacy of a Brief Intervention in Health Consciousness %A Lucas,Gale %A Neeper,Michael %A Linde,Brittany %A Bennett,Joel %+ Organizational Wellness and Learning Systems, 3200 Riverfront Dr, Suite 102, Fort Worth, TX, 76107, United States, 1 817 921 4260, owlsresearch@organizationalwellness.com %K prescription drugs %K health %K consciousness %K education %K workplace %K substance-related disorders %D 2017 %7 06.07.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: It is becoming more commonplace for employees to use prescription medication outside of intended use. Opioid and other prescription misuse has implications for the health and productivity of workers. Easy-to-access webinars that help employees learn about alternatives to prescription use may decrease risk. Objective: The aim of this study was to examine the efficacy of an interactive but brief health consciousness and prescription drug intervention for a diverse sample of employees and show effectiveness via both Internet-delivered webinar and classroom delivery. Methods: Employees from a variety of workplaces filled out pre- and post-questionnaires upon completion of a one-hour long intervention. Results: A total of 114 participants completed the pre- and post-questionnaires. Results showed that, compared with before the training, participants reported significantly more knowledge about prescription drug misuse and alternatives to prescription drug use after the training (t113=7.91, P<.001). Moreover, the medium of presentation (ie, face-to-face vs webinar) did not significantly impact effectiveness of the training (F1,98=1.15, P=.29). Conclusions: In both webinar and classroom formats, participants gained knowledge about alternatives to prescription drug use. This intervention appears to be beneficial to employees and assists in the awareness of prescription drug use in general and in the workplace. %M 28684383 %R 10.2196/jmir.7828 %U http://www.jmir.org/2017/7/e242/ %U https://doi.org/10.2196/jmir.7828 %U http://www.ncbi.nlm.nih.gov/pubmed/28684383 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 7 %P e235 %T Desirable Components for a Customized, Home-Based, Digital Care-Management App for Children and Young People With Long-Term, Chronic Conditions: A Qualitative Exploration %A Nightingale,Ruth %A Hall,Andrew %A Gelder,Carole %A Friedl,Simone %A Brennan,Eileen %A Swallow,Veronica %+ Great Ormond Street Hospital for Children, NHS Foundation Trust, Great Ormond Street, London,, United Kingdom, 44 7825 098844, ruth.nightingale@gosh.nhs.uk %K child %K adolescent %K long-term condition %K chronic condition %K self-management %K self-care %K mobile apps %K apps %K qualitative %D 2017 %7 04.07.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Mobile apps for mobile phones and tablet devices are widely used by children and young people aged 0-18 years with long-term health conditions, such as chronic kidney disease (CKD), and their healthy peers for social networking or gaming. They are also poised to become a major source of health guidance. However, app development processes that are coproduced, rigorously developed, and evaluated to provide tailored, condition-specific, practical advice on day-to-day care management are seldom systematic or sufficiently described to enable replication. Furthermore, attempts to extrapolate to the real world are hampered by a poor understanding of the effects of key elements of app components. Therefore, effective and cost-effective novel, digital apps that will effectively and safely support care management are critical and timely. To inform development of such an app for children with CKD, a user requirements-gathering exercise was first needed. Objective: To explore the views of children with CKD, their parents, and health care professionals to inform future development of a child-focused, care-management app. Methods: Using age- and developmentally appropriate methods, we interviewed 36 participants: 5-10-year-olds (n=6), 11-14-year-olds (n=6), 15-18-year-olds (n=5), mothers (n=10), fathers (n=2), and health care professionals (n=7). Data were analyzed using Framework Analysis and behavior change theories. Results: Of the 27 interviews, 19 (70%) interviews were individual and 8 (30%) were joint—5 out of 8 (63%) joint interviews were with a child or young person and their parent, 1 out of 8 (13%) were with a child and both parents, and 2 out of 8 (25%) were with 2 professionals. Three key themes emerged to inform development of a software requirement specification for a future home-based, digital care-management app intervention: (1) Gaps in current online information and support, (2) Difficulties experienced by children with a long-term condition, and (3) Suggestions for a digital care-management app. Reported gaps included the fact that current online information is not usually appropriate for children as it is “dry” and “boring,” could be “scary,” and was either hard to understand or not relevant to individuals’ circumstances. For children, searching online was much less accessible than using a professional-endorsed mobile app. Children also reported difficulty explaining their condition to others, maintaining treatment adherence, coping with feeling isolated, and with trying to live a “normal” life. There was recognition that a developmentally appropriate, CKD-specific app could support the process of explaining the condition to healthy peers, reducing isolation, adhering to care-management plans, and living a “normal” life. Participants recommended a range of media and content to include in a tailored, interactive, age- and developmentally appropriate app. For example, the user would be able to enter their age and diagnosis so that only age-appropriate and condition-specific content is displayed. Conclusions: Future development of a digital app that meets the identified information and support needs and preferences of children with CKD will maximize its utility, thereby augmenting CKD caregiving and optimizing outcomes. %M 28676470 %R 10.2196/jmir.7760 %U http://www.jmir.org/2017/7/e235/ %U https://doi.org/10.2196/jmir.7760 %U http://www.ncbi.nlm.nih.gov/pubmed/28676470 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 3 %N 2 %P e8 %T Cancer-Related Fatigue in Post-Treatment Cancer Survivors: Theory-Based Development of a Web-Based Intervention %A Corbett,Teresa %A Walsh,Jane C %A Groarke,AnnMarie %A Moss-Morris,Rona %A Morrissey,Eimear %A McGuire,Brian E %+ Centre for Clinical and Community Applications of Health Psychology (CCCAHP), School of Psychology, Faculty of Social, Human and Mathematical Sciences, University of Southampton, Southampton, SO17 1BJ, United Kingdom, 44 238059 ext 7045, T.K.Corbett@soton.ac.uk %K cancer %K survivor %K design %K person-based approach %K theory %D 2017 %7 04.07.2017 %9 Original Paper %J JMIR Cancer %G English %X Background: Cancer-related fatigue (CrF) is the most common and disruptive symptom experienced by cancer survivors. We aimed to develop a theory-based, interactive Web-based intervention designed to facilitate self-management and enhance coping with CrF following cancer treatment. Objective: The aim of our study was to outline the rationale, decision-making processes, methods, and findings which led to the development of a Web-based intervention to be tested in a feasibility trial. This paper outlines the process and method of development of the intervention. Methods: An extensive review of the literature and qualitative research was conducted to establish a therapeutic approach for this intervention, based on theory. The psychological principles used in the development process are outlined, and we also clarify hypothesized causal mechanisms. We describe decision-making processes involved in the development of the content of the intervention, input from the target patient group and stakeholders, the design of the website features, and the initial user testing of the website. Results: The cocreation of the intervention with the experts and service users allowed the design team to ensure that an acceptable intervention was developed. This evidence-based Web-based program is the first intervention of its kind based on self-regulation model theory, with the primary aim of targeting the representations of fatigue and enhancing self-management of CrF, specifically. Conclusions: This research sought to integrate psychological theory, existing evidence of effective interventions, empirically derived principles of Web design, and the views of potential users into the systematic planning and design of the intervention of an easy-to-use website for cancer survivors. %M 28676465 %R 10.2196/cancer.6987 %U http://cancer.jmir.org/2017/2/e8/ %U https://doi.org/10.2196/cancer.6987 %U http://www.ncbi.nlm.nih.gov/pubmed/28676465 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 6 %P e123 %T The Feasibility and Acceptability of a Web-Based Alcohol Management Intervention in Community Sports Clubs: A Cross-Sectional Study %A McFadyen,Tameka %A Wolfenden,Luke %A Wiggers,John %A Tindall,Jenny %A Yoong,Sze Lin %A Lecathelinais,Christophe %A Gillham,Karen %A Sherker,Shauna %A Rowland,Bosco %A McLaren,Nicola %A Kingsland,Melanie %+ School of Medicine and Public Health, Faculty of Health, The University of Newcastle, Booth Building, Longworth Avenue, Wallsend,, Australia, 61 2 4926 6499 ext 6499, tameka-rae.small@hnehealth.nsw.gov.au %K alcohol %K sports %K implementation %K technology %K TAM %K Web %K Internet %K eHealth %D 2017 %7 30.06.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: The implementation of comprehensive alcohol management strategies can reduce excessive alcohol use and reduce the risk of alcohol-related harm at sporting venues. Supporting sports venues to implement alcohol management strategies via the Web may represent an effective and efficient means of reducing harm caused by alcohol in this setting. However, the feasibility and acceptability of such an approach is unknown. Objective: This study aimed to identify (1) the current access to and use of the Web and electronic devices by sports clubs; (2) the perceived usefulness, ease of use, and intention to use a Web-based program to support implementation of alcohol management policies in sports clubs; (3) the factors associated with intention to use such a Web-based support program; and (4) the specific features of such a program that sports clubs would find useful. Methods: A cross-sectional survey was conducted with club administrators of community football clubs in the state of New South Wales, Australia. Perceived usefulness, ease of use and intention to use a hypothetical Web-based alcohol management support program was assessed using the validated Technology Acceptance Model (TAM) instrument. Associations between intention to use a Web-based program and club characteristics as well as perceived ease of use and usefulness was tested using Fisher’s exact test and represented using relative risk (RR) for high intention to use the program. Results: Of the 73 football clubs that were approached to participate in the study, 63 consented to participate and 46 were eligible and completed the survey. All participants reported having access to the Web and 98% reported current use of electronic devices (eg, computers, iPads/tablets, smartphones, laptops, televisions, and smartboards). Mean scores (out of a possible 7) for the TAM constructs were high for intention to use (mean 6.25, SD 0.87), perceived ease of use (mean 6.00, SD 0.99), and perceived usefulness (mean 6.17, SD 0.85). Intention to use the Web-based alcohol management program was significantly associated with perceived ease of use (P=.02, RR 1.4, CI 1.0-2.9), perceived usefulness (P=.03, RR 1.5, CI 1.0-6.8) and club size (P=.02, RR 0.8, CI 0.5-0.9). The most useful features of such a program included the perceived ability to complete program requirements within users’ own time, complete program accreditation assessment and monitoring online, develop tailored action plans, and receive email reminders and prompts to complete action. Conclusions: A Web-based alcohol management approach to support sports clubs in the implementation of recommended alcohol management policies appears both feasible and acceptable. Future research should aim to determine if such intended use leads to actual use and club implementation of alcohol management policies. %M 28666977 %R 10.2196/resprot.6859 %U http://www.researchprotocols.org/2017/6/e123/ %U https://doi.org/10.2196/resprot.6859 %U http://www.ncbi.nlm.nih.gov/pubmed/28666977 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 4 %N 2 %P e26 %T Preferences for Internet-Based Mental Health Interventions in an Adult Online Sample: Findings From an Online Community Survey %A Batterham,Philip J %A Calear,Alison L %+ Centre for Mental Health Research, Research School of Population Health, The Australian National University, 63 Eggleston Road, Acton ACT, 2601, Australia, 61 61251031, philip.batterham@anu.edu.au %K Internet interventions %K mental health services %K preferences %K anxiety %K depression %D 2017 %7 30.06.2017 %9 Original Paper %J JMIR Ment Health %G English %X Background: Despite extensive evidence that Internet interventions are effective in treating mental health problems, uptake of Internet programs is suboptimal. It may be possible to make Internet interventions more accessible and acceptable through better understanding of community preferences for delivery of online programs. Objective: This study aimed to assess community preferences for components, duration, frequency, modality, and setting of Internet interventions for mental health problems. Methods: A community-based online sample of 438 Australian adults was recruited using social media advertising and administered an online survey on preferences for delivery of Internet interventions, along with scales assessing potential correlates of these preferences. Results: Participants reported a preference for briefer sessions, although they recognized a trade-off between duration and frequency of delivery. No clear preference for the modality of delivery emerged, although a clear majority preferred tailored programs. Participants preferred to access programs through a computer rather than a mobile device. Although most participants reported that they would seek help for a mental health problem, more participants had a preference for face-to-face sources only than online programs only. Younger, female, and more educated participants were significantly more likely to prefer Internet delivery. Conclusions: Adults in the community have a preference for Internet interventions with short modules that are tailored to individual needs. Individuals who are reluctant to seek face-to-face help may also avoid Internet interventions, suggesting that better implementation of existing Internet programs requires increasing acceptance of Internet interventions and identifying specific subgroups who may be resistant to seeking help. %M 28666976 %R 10.2196/mental.7722 %U http://mental.jmir.org/2017/2/e26/ %U https://doi.org/10.2196/mental.7722 %U http://www.ncbi.nlm.nih.gov/pubmed/28666976 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 6 %P e232 %T Developing and Evaluating Digital Interventions to Promote Behavior Change in Health and Health Care: Recommendations Resulting From an International Workshop %A Michie,Susan %A Yardley,Lucy %A West,Robert %A Patrick,Kevin %A Greaves,Felix %+ Centre for Behaviour Change, Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London, WC1E 7HB, United Kingdom, 44 2076795930, s.michie@ucl.ac.uk %K health behavior %K psychological theory %K mobile applications %K behavioral medicine %K mHealth %K eHealth %D 2017 %7 29.06.2017 %9 Viewpoint %J J Med Internet Res %G English %X Devices and programs using digital technology to foster or support behavior change (digital interventions) are increasingly ubiquitous, being adopted for use in patient diagnosis and treatment, self-management of chronic diseases, and in primary prevention. They have been heralded as potentially revolutionizing the ways in which individuals can monitor and improve their health behaviors and health care by improving outcomes, reducing costs, and improving the patient experience. However, we are still mainly in the age of promise rather than delivery. Developing and evaluating these digital interventions presents new challenges and new versions of old challenges that require use of improved and perhaps entirely new methods for research and evaluation. This article discusses these challenges and provides recommendations aimed at accelerating the rate of progress in digital behavior intervention research and practice. Areas addressed include intervention development in a rapidly changing technological landscape, promoting user engagement, advancing the underpinning science and theory, evaluating effectiveness and cost-effectiveness, and addressing issues of regulatory, ethical, and information governance. This article is the result of a two-day international workshop on how to create, evaluate, and implement effective digital interventions in relation to health behaviors. It was held in London in September 2015 and was supported by the United Kingdom’s Medical Research Council (MRC), the National Institute for Health Research (NIHR), the Methodology Research Programme (PI Susan Michie), and the Robert Wood Johnson Foundation of the United States (PI Kevin Patrick). Important recommendations to manage the rapid pace of change include considering using emerging techniques from data science, machine learning, and Bayesian approaches and learning from other disciplines including computer science and engineering. With regard to assessing and promoting engagement, a key conclusion was that sustained engagement is not always required and that for each intervention it is useful to establish what constitutes “effective engagement,” that is, sufficient engagement to achieve the intended outcomes. The potential of digital interventions for testing and advancing theories of behavior change by generating ecologically valid, real-time objective data was recognized. Evaluations should include all phases of the development cycle, designed for generalizability, and consider new experimental designs to make the best use of rich data streams. Future health economics analyses need to recognize and model the complex and potentially far-reaching costs and benefits of digital interventions. In terms of governance, developers of digital behavior interventions should comply with existing regulatory frameworks, but with consideration for emerging standards around information governance, ethics, and interoperability. %M 28663162 %R 10.2196/jmir.7126 %U http://www.jmir.org/2017/6/e232/ %U https://doi.org/10.2196/jmir.7126 %U http://www.ncbi.nlm.nih.gov/pubmed/28663162 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 6 %P e231 %T Informing the Design of “Lifestyle Monitoring” Technology for the Detection of Health Deterioration in Long-Term Conditions: A Qualitative Study of People Living With Heart Failure %A Hargreaves,Sarah %A Hawley,Mark S %A Haywood,Annette %A Enderby,Pamela M %+ Centre for Assistive Technology and Connected Healthcare, School of Health and Related Research, University of Sheffield, Innovation Centre, 217 Portobello, Sheffield, S1 4DP, United Kingdom, 44 114 2220682, mark.hawley@sheffield.ac.uk %K independent living %K human activities %K heart failure %K biomedical technology %D 2017 %7 28.06.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Health technologies are being developed to help people living at home manage long-term conditions. One such technology is “lifestyle monitoring” (LM), a telecare technology based on the idea that home activities may be monitored unobtrusively via sensors to give an indication of changes in health-state. However, questions remain about LM technology: how home activities change when participants experience differing health-states; and how sensors might capture clinically important changes to inform timely interventions. Objective: The objective of this paper was to report the findings of a study aimed at identifying changes in activity indicative of important changes in health in people with long-term conditions, particularly changes indicative of exacerbation, by exploring the relationship between home activities and health among people with heart failure (HF). We aimed to add to the knowledge base informing the development of home monitoring technologies designed to detect health deterioration in order to facilitate early intervention and avoid hospital admissions. Methods: This qualitative study utilized semistructured interviews to explore everyday activities undertaken during the three health-states of HF: normal days, bad days, and exacerbations. Potential recruits were identified by specialist nurses and attendees at an HF support group. The sample was purposively selected to include a range of experience of living with HF. Results: The sample comprised a total of 20 people with HF aged 50 years and above, and 11 spouses or partners of the individuals with HF. All resided in Northern England. Participant accounts revealed that home activities are in part shaped by the degree of intrusion from HF symptoms. During an exacerbation, participants undertook activities specifically to ease symptoms, and detailed activity changes were identified. Everyday activity was also influenced by a range of factors other than health. Conclusions: The study highlights the importance of careful development of LM technology to identify changes in activities that occur during clinically important changes in health. These detailed activity changes need to be considered by developers of LM sensors, platforms, and algorithms intended to detect early signs of deterioration. Results suggest that for LM to move forward, sensor set-up should be personalized to individual circumstances and targeted at individual health conditions. LM needs to take account of the uncertainties that arise from placing technology within the home, in order to inform sensor set-up and data interpretation. This targeted approach is likely to yield more clinically meaningful data and address some of the ethical issues of remote monitoring. %M 28659253 %R 10.2196/jmir.6931 %U http://www.jmir.org/2017/6/e231/ %U https://doi.org/10.2196/jmir.6931 %U http://www.ncbi.nlm.nih.gov/pubmed/28659253 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 6 %P e217 %T Web-Based Alcohol Intervention: Study of Systematic Attrition of Heavy Drinkers %A Radtke,Theda %A Ostergaard,Mathias %A Cooke,Richard %A Scholz,Urte %+ Department of Psychology, Applied Social and Health Psychology, University of Zurich, Binzmühlestrasse 14/14, Zurich, 8050, Switzerland, 41 44 635 72 55, theda.radtke@uzh.ch %K attrition %K dropout %K alcohol drinking %K intervention study %K Internet %K surveys and questionnaires %K university student drinking %K motivation %D 2017 %7 28.06.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based alcohol interventions are a promising way to reduce alcohol consumption because of their anonymity and the possibility of reaching a high numbers of individuals including heavy drinkers. However, Web-based interventions are often characterized by high rates of attrition. To date, very few studies have investigated whether individuals with higher alcohol consumption show higher attrition rates in Web-based alcohol interventions as compared with individuals with lower alcohol consumption. Objectives: The aim of this study was to examine the attrition rate and predictors of attrition in a Web-based intervention study on alcohol consumption. Methods: The analysis of the predictors of attrition rate was performed on data collected in a Web-based randomized control trial. Data collection took place at the University of Konstanz, Germany. A total of 898 people, which consisted of 46.8% males (420/898) and 53.2% females (478/898) with a mean age of 23.57 years (SD 5.19), initially volunteered to participate in a Web-based intervention study to reduce alcohol consumption. Out of the sample, 86.9% (781/898) were students. Participants were classified as non-completers (439/898, 48.9%) if they did not complete the Web-based intervention. Potential predictors of attrition were self-reported: alcohol consumption in the last seven days, per week, from Monday to Thursday, on weekends, excessive drinking behavior measured with the Alcohol Use Disorder Identification Test (AUDIT), and drinking motives measured by the Drinking Motive Questionnaire (DMQ-R SF). Results: Significant differences between completers and non-completers emerged regarding alcohol consumption in the last seven days (B=−.02, P=.05, 95% CI [0.97-1.00]), on weekends (B=−.05, P=.003, 95% CI [0.92-0.98]), the AUDIT (B=−.06, P=.007, 95% CI [0.90-0.98], and the status as a student (B=.72, P=.001, 95% CI [1.35-3.11]). Most importantly, non-completers had a significantly higher alcohol consumption compared with completers. Conclusions: Hazardous alcohol consumption appears to be a key factor of the dropout rate in a Web-based alcohol intervention study. Thus, it is important to develop strategies to keep participants who are at high risk in Web-based interventions. %M 28659251 %R 10.2196/jmir.6780 %U http://www.jmir.org/2017/6/e217/ %U https://doi.org/10.2196/jmir.6780 %U http://www.ncbi.nlm.nih.gov/pubmed/28659251 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 6 %P e86 %T A Community-Based Physical Activity Counselling Program for People With Knee Osteoarthritis: Feasibility and Preliminary Efficacy of the Track-OA Study %A Li,Linda C %A Sayre,Eric C %A Xie,Hui %A Clayton,Cam %A Feehan,Lynne M %+ Arthritis Research Canada, 5591 No. 3 Road, Richmond, BC, V6X 2C7, Canada, 1 604 207 4020, lli@arthritisresearch.ca %K osteoarthritis %K physical activity %K sedentary behavior %K sedentary lifestyle %K wearables %K digital technology %K fitness trackers %K exercise %D 2017 %7 26.06.2017 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Physical activity can improve health outcomes in people with knee osteoarthritis (OA); however, participation in physical activity is very low in this population. Objective: The objective of our study was to assess the feasibility and preliminary efficacy of the use of wearables (Fitbit Flex) and telephone counselling by a physical therapist (PT) for improving physical activity in people with a physician-confirmed diagnosis of knee OA, or who have passed 2 validated criteria for early OA. Methods: We conducted a community-based feasibility randomized controlled trial. The immediate group (n=17) received a brief education session by a physical therapist, a Fitbit Flex activity tracker, and a weekly telephone call for activity counselling with the physical therapist. The delayed group (n=17) received the same intervention 1 month later. All participants were assessed at baseline (T0), and the end of 1 month (T1) and 2 months (T2). Outcomes were (1) mean moderate to vigorous physical activity time, (2) mean time spent on sedentary behavior, (3) Knee Injury and Osteoarthritis Outcome Score (KOOS), and (4) Partners in Health Scale. Feasibility data were summarized with descriptive statistics. We used analysis of covariance to evaluate the effect of the group type on the outcome measures at T1 and T2, after adjusting for blocking and T0. We assessed planned contrasts of changes in outcome measures over measurement periods. Results: We identified 46 eligible individuals; of those, 34 (74%) enrolled and no one dropped out. All but 1 participant adhered to the intervention protocol. We found a significant effect, with the immediate intervention group having improved in the moderate to vigorous physical activity time and in the Partners in Health Scale at T0 to T1 compared with the delayed intervention group. The planned contrast of the immediate intervention group at T0 to T1 versus the delayed group at T1 to T2 showed a significant effect in the sedentary time and the KOOS symptoms subscale, favoring the delayed group. Conclusions: This study demonstrated the feasibility of a behavioral intervention, supported by the use of a wearable device, to promote physical activity among people with knee OA. Trial Registration: ClinicalTrials.gov NCT02313506; https://clinicaltrials.gov/ct2/show/NCT02313506 (Archived by WebCite at http://www.webcitation.org/6r4P3Bub0) %M 28652228 %R 10.2196/mhealth.7863 %U http://mhealth.jmir.org/2017/6/e86/ %U https://doi.org/10.2196/mhealth.7863 %U http://www.ncbi.nlm.nih.gov/pubmed/28652228 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 6 %P e229 %T Web-Based Interventions for Weight Loss or Weight Loss Maintenance in Overweight and Obese People: A Systematic Review of Systematic Reviews %A Sorgente,Angela %A Pietrabissa,Giada %A Manzoni,Gian Mauro %A Re,Federica %A Simpson,Susan %A Perona,Sara %A Rossi,Alessandro %A Cattivelli,Roberto %A Innamorati,Marco %A Jackson,Jeffrey B %A Castelnuovo,Gianluca %+ Department of Psychology, Catholic University of the Sacred Heart, L.go Gemelli, 1, Milan,, Italy, 39 3495324303, giada.pietrabissa@unicatt.it %K Internet %K review %K delivery of health care %K obesity %K overweight %K telemedicine %K weight loss %K body weight maintenance %K treatment outcome %D 2017 %7 26.06.2017 %9 Review %J J Med Internet Res %G English %X Background: Weight loss is challenging and maintenance of weight loss is problematic. Web-based programs offer good potential for delivery of interventions for weight loss or weight loss maintenance. However, the precise impact of Web-based weight management programs is still unclear. Objective: The purpose of this meta-systematic review was to provide a comprehensive summary of the efficacy of Web-based interventions for weight loss and weight loss maintenance. Methods: Electronic databases were searched for systematic reviews and meta-analyses that included at least one study investigating the effect of a Web-based intervention on weight loss and/or weight loss maintenance among samples of overweight and/or obese individuals. Twenty identified reviews met the inclusion criteria. The Revised Assessment of Multiple SysTemAtic Reviews (R-AMSTAR) was used to assess methodological quality of reviews. All included reviews were of sufficient methodological quality (R-AMSTAR score ≥22). Key methodological and outcome data were extracted from each review. Results: Web-based interventions for both weight loss and weight loss maintenance were more effective than minimal or control conditions. However, when contrasted with comparable non-Web-based interventions, results were less consistent across reviews. Conclusions: Overall, the efficacy of weight loss maintenance interventions was stronger than the efficacy of weight loss interventions, but further evidence is needed to more clearly understand the efficacy of both types of Web-based interventions. Trial Registration: PROSPERO 2015: CRD42015029377; http://www.crd.york.ac.uk/PROSPERO/display_record.asp? ID=CRD42015029377 (Archived by WebCite at http://www.webcitation.org/6qkSafdCZ) %M 28652225 %R 10.2196/jmir.6972 %U http://www.jmir.org/2017/6/e229/ %U https://doi.org/10.2196/jmir.6972 %U http://www.ncbi.nlm.nih.gov/pubmed/28652225 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 6 %P e230 %T A Review of the Theoretical Basis, Effects, and Cost Effectiveness of Online Smoking Cessation Interventions in the Netherlands: A Mixed-Methods Approach %A Cheung,Kei Long %A Wijnen,Ben %A de Vries,Hein %+ Department of Health Services Research, Maastricht University, Duboisdomein 30, Maastricht,, Netherlands, 31 43 38 82294, kl.cheung@maastrichtuniversity.nl %K Smoking cessation %K telemedicine %K review %K online intervention %K Internet-based intervention %K behavioral change techniques %K Netherlands %D 2017 %7 23.06.2017 %9 Review %J J Med Internet Res %G English %X Background: Tobacco smoking is a worldwide public health problem. In 2015, 26.3% of the Dutch population aged 18 years and older smoked, 74.4% of them daily. More and more people have access to the Internet worldwide; approximately 94% of the Dutch population have online access. Internet-based smoking cessation interventions (online cessation interventions) provide an opportunity to tackle the scourge of tobacco. Objective: The goal of this paper was to provide an overview of online cessation interventions in the Netherlands, while exploring their effectivity, cost effectiveness, and theoretical basis. Methods: A mixed-methods approach was used to identify Dutch online cessation interventions, using (1) a scientific literature search, (2) a grey literature search, and (3) expert input. For the scientific literature, the Cochrane review was used and updated by two independent researchers (n=651 identified studies), screening titles, abstracts, and then full-text studies between 2013 and 2016 (CENTRAL, MEDLINE, and EMBASE). For the grey literature, the researchers conducted a Google search (n=100 websites), screening for titles and first pages. Including expert input, this resulted in six interventions identified in the scientific literature and 39 interventions via the grey literature. Extracted data included effectiveness, cost effectiveness, theoretical factors, and behavior change techniques used. Results: Overall, many interventions (45 identified) were offered. Of the 45 that we identified, only six that were included in trials provided data on effectiveness. Four of these were shown to be effective and cost effective. In the scientific literature, 83% (5/6) of these interventions included changing attitudes, providing social support, increasing self-efficacy, motivating smokers to make concrete action plans to prepare their attempts to quit and to cope with challenges, supporting identity change and advising on changing routines, coping, and medication use. In all, 50% (3/6) of the interventions included a reward for abstinence. Interventions identified in the grey literature were less consistent, with inclusion of each theoretical factor ranging from 31% to 67% and of each behavior change technique ranging from 28% to 54%. Conclusions: Although the Internet may provide the opportunity to offer various smoking cessation programs, the user is left bewildered as far as efficacy is concerned, as most of these data are not available nor offered to the smokers. Clear regulations about the effectiveness of these interventions need to be devised to avoid disappointment and failed quitting attempts. Thus, there is a need for policy regulations to regulate the proliferation of these interventions and to foster their quality in the Netherlands. %M 28645889 %R 10.2196/jmir.7209 %U http://www.jmir.org/2017/6/e230/ %U https://doi.org/10.2196/jmir.7209 %U http://www.ncbi.nlm.nih.gov/pubmed/28645889 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 6 %P e213 %T Effectiveness of a Web-Based Intervention in Reducing Depression and Sickness Absence: Randomized Controlled Trial %A Beiwinkel,Till %A Eißing,Tabea %A Telle,Nils-Torge %A Siegmund-Schultze,Elisabeth %A Rössler,Wulf %+ Innovation Incubator, Competence Tandem Integrated Care, Leuphana University of Lüneburg, Scharnhorststr 1, Lüneburg, 21335, Germany, 49 4131677 ext 7826, till.beiwinkel@leuphana.de %K Internet %K depression %K absenteeism %K cognitive therapy %K randomized controlled trial %D 2017 %7 15.06.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression is highly prevalent in the working population and is associated with significant loss of workdays; however, access to evidence-based treatment is limited. Objective: This study evaluated the effectiveness of a Web-based intervention in reducing mild to moderate depression and sickness absence. Methods: In an open-label randomized controlled trial, participants were recruited from a large-scale statutory health insurance and were assigned to two groups. The intervention group had access to a 12 week Web-based program consisting of structured interactive sessions and therapist support upon request. The wait-list control group had access to unguided Web-based psycho-education. Depressive symptoms were self-assessed at baseline, post-treatment, and follow-up (12 weeks after treatment) using the Patient Health Questionnaire (PHQ-9) and Beck Depression Inventory (BDI-II) as primary outcome measures. Data on sickness absence was retrieved from health insurance records. Intention-to-treat (ITT) analysis and per-protocol (PP) analysis were performed. Results: Of the 180 participants who were randomized, 88 completed the post-assessment (retention rate: 48.8%, 88/180). ITT analysis showed a significant between-group difference in depressive symptoms during post-treatment in favor of the intervention group, corresponding to a moderate effect size (PHQ-9: d=0.55, 95% CI 0.25-0.85, P<.001, and BDI-II: d=0.41, CI 0.11-0.70, P=.004). PP analysis partially supported this result, but showed a non-significant effect on one primary outcome (PHQ-9: d=0.61, 95% CI 0.15-1.07, P=.04, and BDI-II: d=0.25 95% CI −0.18 to 0.65, P=.37). Analysis of clinical significance using reliable change index revealed that significantly more participants who used the Web-based intervention (63%, 63/100) responded to the treatment versus the control group (33%, 27/80; P<.001). The number needed to treat (NNT) was 4.08. Within both groups, there was a reduction in work absence frequency (IG: −67.23%, P<.001, CG: −82.61%, P<.001), but no statistical difference in sickness absence between groups was found (P=.07). Conclusions: The Web-based intervention was effective in reducing depressive symptoms among adults with sickness absence. As this trial achieved a lower power than calculated, its results should be replicated in a larger sample. Further validation of health insurance records as an outcome measure for eHealth trials is needed. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 02446836; http://www.isrctn.com/ISRCTN02446836 (Archived by WebCite at http://www.webcitation.org/6jx4SObnw) %M 28619701 %R 10.2196/jmir.6546 %U http://www.jmir.org/2017/6/e213/ %U https://doi.org/10.2196/jmir.6546 %U http://www.ncbi.nlm.nih.gov/pubmed/28619701 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 6 %P e112 %T Systematic and Iterative Development of a Smartphone App to Promote Sun-Protection Among Holidaymakers: Design of a Prototype and Results of Usability and Acceptability Testing %A Rodrigues,Angela M %A Sniehotta,Falko F %A Birch-Machin,Mark A %A Olivier,Patrick %A Araújo-Soares,Vera %+ Institute of Health and Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle, NE2 4AX, United Kingdom, 44 01912088974, angela.rodrigues@newcastle.ac.uk %K sun-protection %K sunburn %K sunscreening agents %K sunbathing %K health behavior %K health promotion %K formative research %K intervention %D 2017 %7 12.06.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Sunburn and intermittent exposure to ultraviolet rays are risk factors for melanoma. Sunburn is a common experience during holidays, making tourism settings of particular interest for skin cancer prevention. Holidaymakers are a volatile populations found at different locations, which may make them difficult to reach. Given the widespread use of smartphones, evidence suggests that this might be a novel, convenient, scalable, and feasible way of reaching the target population. Objective: The main objective of this study was to describe and appraise the process of systematically developing a smartphone intervention (mISkin app) to promote sun-protection during holidays. Methods: The iterative development process of the mISkin app was conducted over four sequential stages: (1) identify evidence on the most effective behavior change techniques (BCTs) used (active ingredients) as well as theoretical predictors and theories, (2) evidence-based intervention design, (3) co-design with users of the mISkin app prototype, and (4) refinement of the app. Each stage provided key findings that were subsequently used to inform the design of the mISkin app. Results: The sequential approach to development integrates different strands of evidence to inform the design of an evidence-based intervention. A systematic review on previously tested interventions to promote sun-protection provided cues and constraints for the design of this intervention. The development and design of the mISkin app also incorporated other sources of information, such as other literature reviews and experts’ consultations. The developed prototype of the mISkin app was evaluated by engaging potential holidaymakers in the refinement and further development of the mISkin app through usability (ease-of-use) and acceptability testing of the intervention prototype. All 17 participants were satisfied with the mISkin prototype and expressed willingness to use it. Feedback on the app was integrated in the optimization process of the mISkin app. Conclusions: The mISkin app was designed to promote sun-protection among holidaymakers and was based on current evidence, experts’ knowledge and experience, and user involvement. Based on user feedback, the app has been refined and a fully functional version is ready for formal testing in a feasibility pilot study. %M 28606892 %R 10.2196/resprot.7172 %U http://www.researchprotocols.org/2017/6/e112/ %U https://doi.org/10.2196/resprot.7172 %U http://www.ncbi.nlm.nih.gov/pubmed/28606892 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 6 %P e204 %T Young People, Adult Worries: Randomized Controlled Trial and Feasibility Study of the Internet-Based Self-Support Method “Feel the ViBe” for Adolescents and Young Adults Exposed to Family Violence %A van Rosmalen-Nooijens,Karin %A Lo Fo Wong,Sylvie %A Prins,Judith %A Lagro-Janssen,Toine %+ Gender & Women’s Health, Department of Primary and Community Care, Radboud university medical center, Internal post 117, P.O. Box 9101, Nijmegen, 6500HB, Netherlands, 31 0 243613110, karin.vanrosmalen-nooijens@radboudumc.nl %K domestic violence %K child abuse %K exposure to violence %K adolescent %K young adult %K telemedicine %K peer group %K peer influence %K Internet %K feasibility studies %K randomized controlled trial %K delivery of health care %D 2017 %7 12.06.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Adolescents and young adults (AYAs) are of special interest in a group of children exposed to family violence (FV). Past-year prevalence of exposure to FV is known to be highest in AYAs and has severe consequences. Peer support is an effective approach to behavior change and the Internet is considered suitable as a mode of delivery. Objective: The study aimed to evaluate both effectiveness and feasibility of a randomized controlled trial (RCT) and feasibility study of the Internet-based self-support method “Feel the ViBe” (FtV) using mixed-methods approach to fully understand the strengths and weaknesses of a new intervention. Methods: AYAs aged 12-25 years and exposed to FV were randomized in an intervention group (access to FtV + usual care) and a control group (minimally enhanced usual care) after they self-registered themselves. From June 2012 to July 2014, participants completed the Impact of Event Scale (IES) and Depression (DEP) and Anxiety (ANX) subscales of the Symptom CheckList-90-R (SCL-90) every 6 weeks. The Web Evaluation Questionnaire was completed after 12 weeks. Quantitative usage data were collected using Google analytics and content management system (CMS) logs and data files. A univariate analysis of variance (UNIANOVA) and mixed model analysis (intention-to-treat [ITT], complete case) were used to compare groups. Pre-post t tests were used to find within-group effects. Feasibility measures structurally address the findings. The CONsolidated Standards Of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth (CONSORT-EHEALTH) checklist was closely followed. Results: In total, 31 out of 46 participants in the intervention group and 26 out of 47 participants in the control group started FtV. Seventeen participants (intervention: n=8, control: n=9) completed all questionnaires. Mixed model analysis showed significant differences between groups on the SCL-90 DEP (P=.04) and ANX (P=.049) subscales between 6 and 12 weeks after participation started. UNIANOVA showed no significant differences. Pre-post paired sample t tests showed significant improvements after 12 weeks for the SCL-90 DEP (P=.03) and ANX (P=.046) subscales. Reported mean Web-based time per week was 2.83 with a session time of 36 min. FtV was rated a mean 7.47 (1-10 Likert scale) with a helpfulness score of 3.16 (1-5 Likert scale). All participants felt safe. Two-thirds of the intervention participants started regular health care. Conclusions: No changes on the IES were found. SCL-90 DEP and ANX showed promising results; however, the calculated sample size was not reached (n=18). FtV functions best as a first step for adolescents and young adults in an early stage of change. FtV can be easily implemented without extensive resources and fits best in the field of public health care or national governmental care. Trial Registration: Netherlands National Trial Register (NTR): NTR3692; http://www.trialregister.nl/trialreg/admin/ rctview.asp?TC=3692 (Archived by WebCite at http://www.webcitation.org/6qIeKyjA4) %M 28606893 %R 10.2196/jmir.6004 %U http://www.jmir.org/2017/6/e204/ %U https://doi.org/10.2196/jmir.6004 %U http://www.ncbi.nlm.nih.gov/pubmed/28606893 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 6 %P e206 %T Defining and Predicting Patterns of Early Response in a Web-Based Intervention for Depression %A Lutz,Wolfgang %A Arndt,Alice %A Rubel,Julian %A Berger,Thomas %A Schröder,Johanna %A Späth,Christina %A Meyer,Björn %A Greiner,Wolfgang %A Gräfe,Viola %A Hautzinger,Martin %A Fuhr,Kristina %A Rose,Matthias %A Nolte,Sandra %A Löwe,Bernd %A Hohagen,Fritz %A Klein,Jan Philipp %A Moritz,Steffen %+ Department of Psychology, University of Trier, Am Wissenschaftspark 25-27, Trier,, Germany, 49 651 201 2883, wolfgang.lutz@uni-trier.de %K patterns of early change %K depression %K web interventions %K psychotherapy research %D 2017 %7 09.06.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based interventions for individuals with depressive disorders have been a recent focus of research and may be an effective adjunct to face-to-face psychotherapy or pharmacological treatment. Objective: The aim of our study was to examine the early change patterns in Web-based interventions to identify differential effects. Methods: We applied piecewise growth mixture modeling (PGMM) to identify different latent classes of early change in individuals with mild-to-moderate depression (n=409) who underwent a CBT-based web intervention for depression. Results: Overall, three latent classes were identified (N=409): Two early response classes (n=158, n=185) and one early deterioration class (n=66). Latent classes differed in terms of outcome (P<.001) and adherence (P=.03) in regard to the number of modules (number of modules with a duration of at least 10 minutes) and the number of assessments (P<.001), but not in regard to the overall amount of time using the system. Class membership significantly improved outcome prediction by 24.8% over patient intake characteristics (P<.001) and significantly added to the prediction of adherence (P=.04). Conclusions: These findings suggest that in Web-based interventions outcome and adherence can be predicted by patterns of early change, which can inform treatment decisions and potentially help optimize the allocation of scarce clinical resources. %M 28600278 %R 10.2196/jmir.7367 %U http://www.jmir.org/2017/6/e206/ %U https://doi.org/10.2196/jmir.7367 %U http://www.ncbi.nlm.nih.gov/pubmed/28600278 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 6 %P e80 %T A Mobile Phone-Based Health Coaching Intervention for Weight Loss and Blood Pressure Reduction in a National Payer Population: A Retrospective Study %A Mao,Alice Yuqing %A Chen,Connie %A Magana,Candy %A Caballero Barajas,Karla %A Olayiwola,J Nwando %+ Department of Family & Community Medicine, University of California San Francisco, 1001 Potrero Ave, Building 80, San Francisco, CA, 94110, United States, 1 510 296 8868, nwando.olayiwola@ucsf.edu %K digital health coaching %K overweight %K obesity %K mobile health %K weight %K blood pressure %D 2017 %7 08.06.2017 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The prevalence of obesity and associated metabolic conditions continue to be challenging and costly to address for health care systems; 71% of American adults were overweight, with 35% of men and 40% of women diagnosed with obesity in 2014. Digital health coaching is an innovative approach to decreasing the barriers of cost and accessibility of receiving health coaching for the prevention and management of chronic disease in overweight or obese individuals. Objective: To evaluate the early impact of a mobile phone-based health coaching service on weight loss and blood pressure management in a commercially insured population. Methods: This was a retrospective study using existing registry data from a pilot commercial collaboration between Vida Health and a large national insurance provider, which enrolled adult members who were overweight (body mass index >25 kg/m2) and able to engage in a mobile phone-based coaching intervention. Participants received 4 months of intensive health coaching via live video, phone, and text message through the Vida Health app. Participants were also provided with a wireless scale, pedometer, and blood pressure cuff. Of the 1012 enrolled, 763 (75.40%) participants had an initial weight upon enrollment and final weight between 3 and 5 months from enrollment; they served as our intervention group. There were 73 participants out of the 1012 (7.21%) who had weight data 4 months prior to and after Vida coaching, who served as the matched-pair control group. Results: Participants in the intervention group lost an average of 3.23% total body weight (TBW) at 4 months of coaching and 28.6% (218/763) intervention participants achieved a clinically significant weight loss of 5% or more of TBW, with an average of 9.46% weight loss in this cohort. In the matched-pair control group, participants gained on average 1.81% TBW in 4 months without Vida coaching and lost, on average, 2.47% TBW after 4 months of Vida coaching, demonstrating a statistically significant difference of 4.28% in mean percentage weight change (P<.001). Among 151 intervention participants with blood pressure data, 112 (74.2%) had a baseline blood pressure that was above the goal (systolic blood pressure >120 mmHg); 55 out of 112 (49.1%) participants improved their blood pressure at 4 months by an entire hypertensive stage—as defined by the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Conclusions: Mobile phone app-based health coaching interventions can be an acceptable and effective means to promote weight loss and improve blood pressure management in overweight or obese individuals. Given the ubiquity of mobile phones, digital health coaching may be an innovative solution to decreasing barriers of access to much-needed weight management interventions for obesity. %M 28596147 %R 10.2196/mhealth.7591 %U http://mhealth.jmir.org/2017/6/e80/ %U https://doi.org/10.2196/mhealth.7591 %U http://www.ncbi.nlm.nih.gov/pubmed/28596147 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 6 %P e192 %T Using Feedback to Promote Physical Activity: The Role of the Feedback Sign %A Kramer,Jan-Niklas %A Kowatsch,Tobias %+ Center for Digital Health Interventions, Institute of Technology Management, University of St. Gallen, Dufourstrasse 40a, St.Gallen,, Switzerland, 41 0 71 224 ext 7244, tobias.kowatsch@unisg.ch %K feedback %K internet %K physical activity %K health behavior %K activity trackers %D 2017 %7 02.06.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Providing feedback is a technique to promote health behavior that is emphasized by behavior change theories. However, these theories make contradicting predictions regarding the effect of the feedback sign—that is, whether the feedback signals success or failure. Thus, it is unclear whether positive or negative feedback leads to more favorable behavior change in a health behavior intervention. Objective: The aim of this study was to examine the effect of the feedback sign in a health behavior change intervention. Methods: Data from participants (N=1623) of a 6-month physical activity intervention was used. Participants received a feedback email at the beginning of each month. Feedback was either positive or negative depending on the participants’ physical activity in the previous month. In an exploratory analysis, change in monthly step count averages was used to evaluate the feedback effect. Results: The feedback sign did not predict the change in monthly step count averages over the course of the intervention (b=−84.28, P=.28). Descriptive differences between positive and negative feedback can be explained by regression to the mean. Conclusions: The feedback sign might not influence the effect of monthly feedback emails sent out to participants of a large-scale physical activity intervention. However, randomized studies are needed to further support this conclusion. Limitations as well as opportunities for future research are discussed. %M 28576757 %R 10.2196/jmir.7012 %U http://www.jmir.org/2017/6/e192/ %U https://doi.org/10.2196/jmir.7012 %U http://www.ncbi.nlm.nih.gov/pubmed/28576757 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 5 %P e185 %T High Level of Integration in Integrated Disease Management Leads to Higher Usage in the e-Vita Study: Self-Management of Chronic Obstructive Pulmonary Disease With Web-Based Platforms in a Parallel Cohort Design %A Talboom-Kamp,Esther PWA %A Verdijk,Noortje A %A Kasteleyn,Marise J %A Harmans,Lara M %A Talboom,Irvin JSH %A Numans,Mattijs E %A Chavannes,Niels H %+ Saltro Diagnostic Centre, Mississippidreef 83, Utrecht, 3565 CE, Netherlands, 31 302361170, e.talboom@saltro.nl %K COPD %K eHealth %K self-management %K integrated disease management %K self-efficacy %K Web-based platform %K primary care %K chronically ill %K blended care %D 2017 %7 31.05.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Worldwide, nearly 3 million people die of chronic obstructive pulmonary disease (COPD) every year. Integrated disease management (IDM) improves disease-specific quality of life and exercise capacity for people with COPD, but can also reduce hospital admissions and hospital days. Self-management of COPD through eHealth interventions has shown to be an effective method to improve the quality and efficiency of IDM in several settings, but it remains unknown which factors influence usage of eHealth and change in behavior of patients. Objective: Our study, e-Vita COPD, compares different levels of integration of Web-based self-management platforms in IDM in three primary care settings. The main aim of this study is to analyze the factors that successfully promote the use of a self-management platform for COPD patients. Methods: The e-Vita COPD study compares three different approaches to incorporating eHealth via Web-based self-management platforms into IDM of COPD using a parallel cohort design. Three groups integrated the platforms to different levels. In groups 1 (high integration) and 2 (medium integration), randomization was performed to two levels of personal assistance for patients (high and low assistance); in group 3 there was no integration into disease management (none integration). Every visit to the e-Vita and Zorgdraad COPD Web platforms was tracked objectively by collecting log data (sessions and services). At the first log-in, patients completed a baseline questionnaire. Baseline characteristics were automatically extracted from the log files including age, gender, education level, scores on the Clinical COPD Questionnaire (CCQ), dyspnea scale (MRC), and quality of life questionnaire (EQ5D). To predict the use of the platforms, multiple linear regression analyses for the different independent variables were performed: integration in IDM (high, medium, none), personal assistance for the participants (high vs low), educational level, and self-efficacy level (General Self-Efficacy Scale [GSES]). All analyses were adjusted for age and gender. Results: Of the 702 invited COPD patients, 215 (30.6%) registered to a platform. Of the 82 patients in group 1 (high integration IDM), 36 were in group 1A (personal assistance) and 46 in group 1B (low assistance). Of the 96 patients in group 2 (medium integration IDM), 44 were in group 2A (telephone assistance) and 52 in group 2B (low assistance). A total of 37 patients participated in group 3 (no integration IDM). In all, 107 users (49.8%) visited the platform at least once in the 15-month period. The mean number of sessions differed between the three groups (group 1: mean 10.5, SD 1.3; group 2: mean 8.8, SD 1.4; group 3: mean 3.7, SD 1.8; P=.01). The mean number of sessions differed between the high-assistance and low-assistance groups in groups 1 and 2 (high: mean 11.8, SD 1.3; low: mean 6.7, SD 1.4; F1,80=6.55, P=.01). High-assistance participants used more services (mean 45.4, SD 6.2) than low-assistance participants (mean 21.2, SD 6.8; F1,80=6.82, P=.01). No association was found between educational level and usage and between GSES and usage. Conclusions: Use of a self-management platform is higher when participants receive adequate personal assistance about how to use the platform. Blended care, where digital health and usual care are integrated, will likely lead to increased use of the online program. Future research should provide additional insights into the preferences of different patient groups. Trial Registration: Nederlands Trial Register NTR4098; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4098 (Archived by WebCite at http://www.webcitation.org/6qO1hqiJ1) %M 28566268 %R 10.2196/jmir.7037 %U http://www.jmir.org/2017/5/e185/ %U https://doi.org/10.2196/jmir.7037 %U http://www.ncbi.nlm.nih.gov/pubmed/28566268 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 4 %N 2 %P e16 %T Computerized Cognitive Behavioral Therapy to Treat Emotional Distress After Stroke: A Feasibility Randomized Controlled Trial %A Simblett,Sara K %A Yates,Matthew %A Wagner,Adam P %A Watson,Peter %A Gracey,Fergus %A Ring,Howard %A Bateman,Andrew %+ Institute of Psychiatry, Psychology and Neuroscience, Department of Psychology, King's College London, De Crespigny Park, London, SE5 8AF, United Kingdom, 44 2078480762, Sara.Simblett@kcl.ac.uk %K cognitive therapy %K technology %K stroke %K depression %K anxiety %D 2017 %7 31.05.2017 %9 Original Paper %J JMIR Ment Health %G English %X Background: Depression and anxiety are common complications following stroke. Symptoms could be treatable with psychological therapy, but there is little research on its efficacy. Objectives: The aim of this study was to investigate (1) the acceptability and feasibility of computerized cognitive behavioral therapy (cCBT) to treat symptoms of depression and anxiety and (2) a trial design for comparing the efficacy of cCBT compared with an active comparator. Methods: Of the total 134 people screened for symptoms of depression and anxiety following stroke, 28 were cluster randomized in blocks with an allocation ratio 2:1 to cCBT (n=19) or an active comparator of computerized cognitive remediation therapy (cCRT, n=9). Qualitative and quantitative feedback was sought on the acceptability and feasibility of both interventions, alongside measuring levels of depression, anxiety, and activities of daily living before, immediately after, and 3 months post treatment. Results: Both cCBT and cCRT groups were rated as near equally useful (mean = 6.4 vs 6.5, d=0.05), while cCBT was somewhat less relevant (mean = 5.5 vs 6.5, d=0.45) but somewhat easier to use (mean = 7.0 vs 6.3, d=0.31). Participants tolerated randomization and dropout rates were comparable with similar trials, with only 3 participants discontinuing due to potential adverse effects; however, dropout was higher from the cCBT arm (7/19, 37% vs 1/9, 11% for cCRT). The trial design required small alterations and highlighted that future-related studies should control for participants receiving antidepressant medication, which significantly differed between groups (P=.05). Descriptive statistics of the proposed outcome measures and qualitative feedback about the cCBT intervention are reported. Conclusions: A pragmatic approach is required to deliver computerized interventions to accommodate individual needs. We report a preliminary investigation to inform the development of a full randomized controlled trial for testing the efficacy of computerized interventions for people with long-term neurological conditions such as stroke and conclude that this is a potentially promising way of improving accessibility of psychological support. %M 28566265 %R 10.2196/mental.6022 %U http://mental.jmir.org/2017/2/e16/ %U https://doi.org/10.2196/mental.6022 %U http://www.ncbi.nlm.nih.gov/pubmed/28566265 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 5 %P e187 %T Dropout From an eHealth Intervention for Adults With Type 2 Diabetes: A Qualitative Study %A Lie,Silje Stangeland %A Karlsen,Bjørg %A Oord,Ellen Renate %A Graue,Marit %A Oftedal,Bjørg %+ Department of Health Studies, University of Stavanger, Kjell Arholms hus, Stavanger, N-4036, Norway, 47 97506752, silje.s.lie@uis.no %K eHealth %K Telehealth %K type 2 diabetes %K Internet %K counseling %K qualitative research %K general practice, self-management %K self-management support %K patient dropouts %D 2017 %7 30.05.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Adequate self-management is the cornerstone of type 2 diabetes treatment, as people make the majority of daily treatment measures and health decisions. The increasing prevalence of type 2 diabetes mellitus (T2DM) and the complexity of diabetes self-management demonstrate the need for innovative and effective ways to deliver self-management support. eHealth interventions are promoted worldwide and hold a great potential in future health care for people with chronic diseases such as T2DM. However, many eHealth interventions face high dropout rates. This led to our interest in the experiences of participants who dropped out of an eHealth intervention for adults with T2DM, based on the Guided Self-Determination (GSD) counseling method. Objective: In this study, we aimed to explore experiences with an eHealth intervention based on GSD in general practice from the perspective of those who dropped out and to understand their reasons for dropping out. To the best of our knowledge, no previous qualitative study has focused on participants who withdrew from an eHealth self-management support intervention for adults with T2DM. Methods: A qualitative design based on telephone interviews was used to collect data. The sample comprised 12 adults with type 2 diabetes who dropped out of an eHealth intervention. Data were collected in 2016 and subjected to qualitative content analysis. Results: We identified one overall theme: “Losing motivation for intervention participation.” This theme was illustrated by four categories related to the participants’ experiences of the eHealth intervention: (1) frustrating technology, (2) perceiving the content as irrelevant and incomprehensible, (3) choosing other activities and perspectives, and (4) lacking face-to-face encounters. Conclusions: Our findings indicate that the eHealth intervention based on GSD without face-to-face encounters with nurses reduced participants’ motivation for engagement in the intervention. To maintain motivation, our study points to the importance of combining eHealth with regular face-to-face consultations. Our study also shows that the perceived benefit of the GSD eHealth intervention intertwined with choosing to focus on other matters in complex daily lives are critical aspects in motivation for such interventions. This indicates the importance of giving potential participants tailored information about the aim, the content, and the effort needed to remain engaged in complex interventions so that eligible participants are recruited. Finally, motivation for engagement in the eHealth intervention was influenced by the technology used in this study. It seems important to facilitate more user-friendly but high-security eHealth technology. Our findings have implications for improving the eHealth intervention and to inform researchers and health care providers who are organizing eHealth interventions focusing on self-management support in order to reduce dropout rates. %M 28559223 %R 10.2196/jmir.7479 %U http://www.jmir.org/2017/5/e187/ %U https://doi.org/10.2196/jmir.7479 %U http://www.ncbi.nlm.nih.gov/pubmed/28559223 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 5 %P e179 %T Digital Support Interventions for the Self-Management of Low Back Pain: A Systematic Review %A Nicholl,Barbara I %A Sandal,Louise F %A Stochkendahl,Mette J %A McCallum,Marianne %A Suresh,Nithya %A Vasseljen,Ottar %A Hartvigsen,Jan %A Mork,Paul J %A Kjaer,Per %A Søgaard,Karen %A Mair,Frances S %+ General Practice & Primary Care, Institute of Health & Wellbeing, University of Glasgow, 1 Horselethill Road, Glasgow, G12 9LX, United Kingdom, 44 141 3308327, barbara.nicholl@glasgow.ac.uk %K low back pain %K self-management %K mHealth %K eHealth %D 2017 %7 21.5.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Low back pain (LBP) is a common cause of disability and is ranked as the most burdensome health condition globally. Self-management, including components on increased knowledge, monitoring of symptoms, and physical activity, are consistently recommended in clinical guidelines as cost-effective strategies for LBP management and there is increasing interest in the potential role of digital health. Objective: The study aimed to synthesize and critically appraise published evidence concerning the use of interactive digital interventions to support self-management of LBP. The following specific questions were examined: (1) What are the key components of digital self-management interventions for LBP, including theoretical underpinnings? (2) What outcome measures have been used in randomized trials of digital self-management interventions in LBP and what effect, if any, did the intervention have on these? and (3) What specific characteristics or components, if any, of interventions appear to be associated with beneficial outcomes? Methods: Bibliographic databases searched from 2000 to March 2016 included Medline, Embase, CINAHL, PsycINFO, Cochrane Library, DoPHER and TRoPHI, Social Science Citation Index, and Science Citation Index. Reference and citation searching was also undertaken. Search strategy combined the following concepts: (1) back pain, (2) digital intervention, and (3) self-management. Only randomized controlled trial (RCT) protocols or completed RCTs involving adults with LBP published in peer-reviewed journals were included. Two reviewers independently screened titles and abstracts, full-text articles, extracted data, and assessed risk of bias using Cochrane risk of bias tool. An independent third reviewer adjudicated on disagreements. Data were synthesized narratively. Results: Of the total 7014 references identified, 11 were included, describing 9 studies: 6 completed RCTs and 3 protocols for future RCTs. The completed RCTs included a total of 2706 participants (range of 114-1343 participants per study) and varied considerably in the nature and delivery of the interventions, the duration/definition of LBP, the outcomes measured, and the effectiveness of the interventions. Participants were generally white, middle aged, and in 5 of 6 RCT reports, the majority were female and most reported educational level as time at college or higher. Only one study reported between-group differences in favor of the digital intervention. There was considerable variation in the extent of reporting the characteristics, components, and theories underpinning each intervention. None of the studies showed evidence of harm. Conclusions: The literature is extremely heterogeneous, making it difficult to understand what might work best, for whom, and in what circumstances. Participants were predominantly female, white, well educated, and middle aged, and thus the wider applicability of digital self-management interventions remains uncertain. No information on cost-effectiveness was reported. The evidence base for interactive digital interventions to support patient self-management of LBP remains weak. %M 28550009 %R 10.2196/jmir.7290 %U http://www.jmir.org/2017/5/e179/ %U https://doi.org/10.2196/jmir.7290 %U http://www.ncbi.nlm.nih.gov/pubmed/28550009 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 5 %P e147 %T More Than a Text Message: Dismantling Digital Triggers to Curate Behavior Change in Patient-Centered Health Interventions %A Muench,Frederick %A Baumel,Amit %+ Psychiatry, Northwell Health, 311, 1010 Northern Blvd, Great Neck, NY, 11021, United States, 1 191 532 0623, fmuench@northwell.edu %K alerts %K digital triggers %K text messaging %K haptic triggers %K reminder systems %K push alerts %K mHealth %K mobile health %K engagement %K marketing %K behavior change %K behavioral medicine %D 2017 %7 26.05.2017 %9 Viewpoint %J J Med Internet Res %G English %X Digital triggers such as text messages, emails, and push alerts are designed to focus an individual on a desired goal by prompting an internal or external reaction at the appropriate time. Triggers therefore have an essential role in engaging individuals with digital interventions delivered outside of traditional health care settings, where other events in daily lives and fluctuating motivation to engage in effortful behavior exist. There is an emerging body of literature examining the use of digital triggers for short-term action and longer-term behavior change. However, little attention has been given to understanding the components of digital triggers. Using tailoring as an overarching framework, we separated digital triggers into 5 primary components: (1) who (sender), (2) how (stimulus type, delivery medium, heterogeneity), (3) when (delivered), (4) how much (frequency, intensity), and (5) what (trigger’s target, trigger’s structure, trigger’s narrative). We highlighted key considerations when tailoring each component and the pitfalls of ignoring common mistakes, such as alert fatigue and habituation. As evidenced throughout the paper, there is a broad literature base from which to draw when tailoring triggers to curate behavior change in health interventions. More research is needed, however, to examine differences in efficacy based on component tailoring, to best use triggers to facilitate behavior change over time, and to keep individuals engaged in physical and mental health behavior change efforts. Dismantling digital triggers into their component parts and reassembling them according to the gestalt of one’s change goals is the first step in this development work. %M 28550001 %R 10.2196/jmir.7463 %U http://www.jmir.org/2017/5/e147/ %U https://doi.org/10.2196/jmir.7463 %U http://www.ncbi.nlm.nih.gov/pubmed/28550001 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 5 %P e157 %T Web-Based Cognitive Behavior Therapy for Depression in People With Diabetes Mellitus: A Randomized Controlled Trial %A Newby,Jill %A Robins,Lisa %A Wilhelm,Kay %A Smith,Jessica %A Fletcher,Therese %A Gillis,Inika %A Ma,Trevor %A Finch,Adam %A Campbell,Lesley %A Andrews,Gavin %+ School of Psychology, The University of New South Wales, 1302 Mathews Building, Randwick, 2052, Australia, 61 293853425, j.newby@unsw.edu.au %K depression %K diabetes mellitus %K cognitive behavior therapy %K diabetes-related distress %K computer-assisted therapy %D 2017 %7 15.05.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression is twice as common in diabetes mellitus (DM) as the general population and is associated with adverse health outcomes, but access to evidence-based therapies such as cognitive behavioral therapy (CBT) is limited in routine diabetes care. Past research has shown that generic Internet-based cognitive behavioral therapy (iCBT) is an effective treatment for depression in the general population, but it has never been evaluated in people with comorbid depression and DM. Objective: The aim of our study was to examine the efficacy of a generic 6-lesson iCBT delivered over 10 weeks in people with major depressive disorder (MDD) and DM. Methods: Participants with comorbid MDD and DM (type 1 or 2) were recruited online and randomized to an iCBT program with therapist support provided by phone and email (n=42) or a treatment as usual (TAU, n=49) control group. Outcomes were assessed through Web-based self-report questionnaires and the trial was Web-based with no face-to-face components. Primary outcomes were self-reported depression (patient health questionnaire-9, PHQ-9), diabetes-related distress (problem areas in diabetes, PAID), and self-reported glycemic control (hemoglobin A1c, HbA1c). Secondary outcomes were general distress (Kessler 10-item psychological distress scale, K-10) and disability (short form 12-item, SF-12), generalized anxiety (generalized anxiety disorder 7-item, GAD-7), and somatization (PHQ-15). The iCBT group was assessed at 3 months. Results: A total of 27 participants (66%; 27/41) completed the iCBT program. Analyses indicated between-group superiority of iCBT over TAU at posttreatment on PHQ-9 (g=0.78), PAID (g=0.80), K-10 (g=1.06), GAD-7 (g=0.72), and SF-12 mental well-being scores (g=0.66), but no significant differences in self-reported HbA1c levels (g=0.14), SF-12 physical well-being, or PHQ-15 scores (g=0.03-0.21). Gains were maintained at 3-month follow-up in the iCBT group, and the 87% (27/31) of iCBT participants who were interviewed no longer met criteria for MDD. Clinically significant change following iCBT on PHQ-9 scores was 51% (21/41) versus 18% (9/49) in TAU. Conclusions: iCBT for depression is an efficacious, accessible treatment option for people with diabetes. Future studies should explore whether tailoring of iCBT programs improves acceptability and adherence, and evaluate the long-term outcomes following iCBT. Trial Registration: Australian and New Zealand Clinical Trials Registry (ACTRN): 12613001198718; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365208&isReview=true (Archived by WebCite at http://www.webcitation.org/6qCR8Fi9V) %M 28506956 %R 10.2196/jmir.7274 %U http://www.jmir.org/2017/5/e157/ %U https://doi.org/10.2196/jmir.7274 %U http://www.ncbi.nlm.nih.gov/pubmed/28506956 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 5 %P e160 %T What Matters in Weight Loss? An In-Depth Analysis of Self-Monitoring %A Painter,Stefanie Lynn %A Ahmed,Rezwan %A Hill,James O %A Kushner,Robert F %A Lindquist,Richard %A Brunning,Scott %A Margulies,Amy %+ Retrofit INC, 123 N. Wacker Drive, Suite 1250, Chicago, IL, 60606, United States, 1 8007745962, stefanie@retrofitme.com %K behavior %K body mass index %K fitness trackers %K self-monitoring %K obesity %K overweight %K weight loss %D 2017 %7 12.05.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Using technology to self-monitor body weight, dietary intake, and physical activity is a common practice used by consumers and health companies to increase awareness of current and desired behaviors in weight loss. Understanding how to best use the information gathered by these relatively new methods needs to be further explored. Objective: The purpose of this study was to analyze the contribution of self-monitoring to weight loss in participants in a 6-month commercial weight-loss intervention administered by Retrofit and to specifically identify the significant contributors to weight loss that are associated with behavior and outcomes. Methods: A retrospective analysis was performed using 2113 participants enrolled from 2011 to 2015 in a Retrofit weight-loss program. Participants were males and females aged 18 years or older with a starting body mass index of ≥25 kg/m2, who also provided a weight measurement at the sixth month of the program. Multiple regression analysis was performed using all measures of self-monitoring behaviors involving weight measurements, dietary intake, and physical activity to predict weight loss at 6 months. Each significant predictor was analyzed in depth to reveal the impact on outcome. Results: Participants in the Retrofit Program lost a mean –5.58% (SE 0.12) of their baseline weight with 51.87% (1096/2113) of participants losing at least 5% of their baseline weight. Multiple regression model (R2=.197, P<0.001) identified the following measures as significant predictors of weight loss at 6 months: number of weigh-ins per week (P<.001), number of steps per day (P=.02), highly active minutes per week (P<.001), number of food log days per week (P<.001), and the percentage of weeks with five or more food logs (P<.001). Weighing in at least three times per week, having a minimum of 60 highly active minutes per week, food logging at least three days per week, and having 64% (16.6/26) or more weeks with at least five food logs were associated with clinically significant weight loss for both male and female participants. Conclusions: The self-monitoring behaviors of self-weigh-in, daily steps, high-intensity activity, and persistent food logging were significant predictors of weight loss during a 6-month intervention. %M 28500022 %R 10.2196/jmir.7457 %U http://www.jmir.org/2017/5/e160/ %U https://doi.org/10.2196/jmir.7457 %U http://www.ncbi.nlm.nih.gov/pubmed/28500022 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 5 %P e141 %T Efficacy of a Web-Based Guided Recommendation Service for a Curated List of Readily Available Mental Health and Well-Being Mobile Apps for Young People: Randomized Controlled Trial %A Bidargaddi,Niranjan %A Musiat,Peter %A Winsall,Megan %A Vogl,Gillian %A Blake,Victoria %A Quinn,Stephen %A Orlowski,Simone %A Antezana,Gaston %A Schrader,Geoffrey %+ Digital Psychiatry & Personal Health Informatics Group, School of Medicine, Flinders University, Flinders at Tonsley, 1284 South Road, Clovelly Park, 5042, Australia, 61 872218842, niranjan.bidargaddi@flinders.edu.au %K well-being %K mental health %K young people %K online intervention %K apps %K engagement %D 2017 %7 12.05.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Mental disorders are highly prevalent for the people who are aged between 16 and 25 years and can permanently disrupt the development of these individuals. Easily available mobile health (mHealth) apps for mobile phones have great potential for the prevention and early intervention of mental disorders in young adults, but interventions are required that can help individuals to both identify high-quality mobile apps and use them to change health and lifestyle behavior. Objectives: The study aimed to assess the efficacy of a Web-based self-guided app recommendation service (“The Toolbox”) in improving the well-being of young Australians aged between 16 and 25 years. The intervention was developed in collaboration with young adults and consists of a curated list of 46 readily available health and well-being apps, assessed and rated by professionals and young people. Participants are guided by an interactive quiz and subsequently receive recommendations for particular apps to download and use based on their personal goals. Methods: The study was a waitlist, parallel-arm, randomized controlled trial. Our primary outcome measure was change in well-being as measured by the Mental Health Continuum-Short Form (MHC-SF). We also employed ecological momentary assessments (EMAs) to track mood, energy, rest, and sleep. Participants were recruited from the general Australian population, via several Web-based and community strategies. The study was conducted through a Web-based platform consisting of a landing Web page and capabilities to administer study measures at different time points. Web-based measurements were self-assessed at baseline and 4 weeks, and EMAs were collected repeatedly at regular weekly intervals or ad hoc when participants interacted with the study platform. Primary outcomes were analyzed using linear mixed-models and intention-to-treat (ITT) analysis. Results: A total of 387 participants completed baseline scores and were randomized into the trial. Results demonstrated no significant effect of “The Toolbox” intervention on participant well-being at 4 weeks compared with the control group (P=.66). There were also no significant differences between the intervention and control groups at 4 weeks on any of the subscales of the MHC-SF (psychological: P=.95, social: P=.42, emotional: P=.95). Repeat engagement with the study platform resulted in a significant difference in mood, energy, rest, and sleep trajectories between intervention and control groups as measured by EMAs (P<.01). Conclusions: This was the first study to assess the effectiveness of a Web-based well-being intervention in a sample of young adults. The design of the intervention utilized expert rating of existing apps and end-user codesign approaches resulting in an app recommendation service. Our finding suggests that recommended readily available mental health and well-being apps may not lead to improvements in the well-being of a nonclinical sample of young people, but might halt a decline in mood, energy, rest, and sleep. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614000710628; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366145 (Archived by WebCite at http://www.webcitation.org/ 6pWDsnKme) %M 28500020 %R 10.2196/jmir.6775 %U http://www.jmir.org/2017/5/e141/ %U https://doi.org/10.2196/jmir.6775 %U http://www.ncbi.nlm.nih.gov/pubmed/28500020 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 5 %P e151 %T Embodied Conversational Agents in Clinical Psychology: A Scoping Review %A Provoost,Simon %A Lau,Ho Ming %A Ruwaard,Jeroen %A Riper,Heleen %+ Department of Clinical, Neuro & Developmental Psychology, Section Clinical Psychology, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, Amsterdam, 1081 BT, Netherlands, 31 205985059, s.j.provoost@vu.nl %K eHealth %K review %K embodied conversational agent %K human computer interaction %K clinical psychology %K mental disorders %K intelligent agent %K health behavior %D 2017 %7 09.05.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Embodied conversational agents (ECAs) are computer-generated characters that simulate key properties of human face-to-face conversation, such as verbal and nonverbal behavior. In Internet-based eHealth interventions, ECAs may be used for the delivery of automated human support factors. Objective: We aim to provide an overview of the technological and clinical possibilities, as well as the evidence base for ECA applications in clinical psychology, to inform health professionals about the activity in this field of research. Methods: Given the large variety of applied methodologies, types of applications, and scientific disciplines involved in ECA research, we conducted a systematic scoping review. Scoping reviews aim to map key concepts and types of evidence underlying an area of research, and answer less-specific questions than traditional systematic reviews. Systematic searches for ECA applications in the treatment of mood, anxiety, psychotic, autism spectrum, and substance use disorders were conducted in databases in the fields of psychology and computer science, as well as in interdisciplinary databases. Studies were included if they conveyed primary research findings on an ECA application that targeted one of the disorders. We mapped each study’s background information, how the different disorders were addressed, how ECAs and users could interact with one another, methodological aspects, and the study’s aims and outcomes. Results: This study included N=54 publications (N=49 studies). More than half of the studies (n=26) focused on autism treatment, and ECAs were used most often for social skills training (n=23). Applications ranged from simple reinforcement of social behaviors through emotional expressions to sophisticated multimodal conversational systems. Most applications (n=43) were still in the development and piloting phase, that is, not yet ready for routine practice evaluation or application. Few studies conducted controlled research into clinical effects of ECAs, such as a reduction in symptom severity. Conclusions: ECAs for mental disorders are emerging. State-of-the-art techniques, involving, for example, communication through natural language or nonverbal behavior, are increasingly being considered and adopted for psychotherapeutic interventions in ECA research with promising results. However, evidence on their clinical application remains scarce. At present, their value to clinical practice lies mostly in the experimental determination of critical human support factors. In the context of using ECAs as an adjunct to existing interventions with the aim of supporting users, important questions remain with regard to the personalization of ECAs’ interaction with users, and the optimal timing and manner of providing support. To increase the evidence base with regard to Internet interventions, we propose an additional focus on low-tech ECA solutions that can be rapidly developed, tested, and applied in routine practice. %M 28487267 %R 10.2196/jmir.6553 %U http://www.jmir.org/2017/5/e151/ %U https://doi.org/10.2196/jmir.6553 %U http://www.ncbi.nlm.nih.gov/pubmed/28487267 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 5 %P e154 %T Mobile App for Treatment of Stress Urinary Incontinence: A Cost-Effectiveness Analysis %A Sjöström,Malin %A Lindholm,Lars %A Samuelsson,Eva %+ Department of Public Health and Clinical Medicine, Umeå University, Region Jämtland Härjedalen, Box 654, Umeå, SE-832 27, Sweden, 46 703269948, malin.sjostrom@regionjh.se %K mobile application %K pelvic floor %K urinary incontinence, stress %K self care %K cost-benefit analysis %D 2017 %7 08.05.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Mobile apps can increase access to care, facilitate self-management, and improve adherence to treatment. Stress urinary incontinence (SUI) affects 10-35% of women and, currently, an app with instructions for pelvic floor muscle training (PFMT) is available as first-line treatment. A previous randomized controlled study demonstrated that the app benefitted symptom severity and quality of life (QoL); in this study we investigate the cost-effectiveness of the app. Objective: The objective of this study was to evaluate the health economy of the app for treating SUI. Methods: This deterministic cost-utility analysis, with a 1-year societal perspective, compared the app treatment with no treatment. Health economic data were collected alongside a randomized controlled trial performed in Sweden from March 2013 to October 2014. This study included 123 community-dwelling women participants of 18 years and above, with stress urinary incontinence ≥1 time per week. Participants were self-assessed with validated questionnaires and 2-day leakage diaries, and then randomized to 3 months of treatment (app group, n=62) or no treatment (controls, n=61). The app focused on pelvic floor muscle training, prescribed 3 times daily. We continuously registered treatment delivery costs. Data were collected on each participant’s training time, incontinence aids, and laundry at baseline and at a 3-month follow-up. We measured quality of life with the International Consultation on Incontinence Modular Questionnaire on Lower Urinary Tract Symptoms and Quality of Life, and calculated the quality-adjusted life years (QALYs) gained. Data from the 3-month follow-up were extrapolated to 1 year for the calculations. Our main outcome was the incremental cost-effectiveness ratios compared between app and control groups. One-way and multiway sensitivity analyses were performed. Results: The mean age of participants was 44.7 years (SD 9.4). Annual costs were €547.0 for the app group and €482.4 for the control group. Annual gains in quality-adjusted life years for app and control groups were 0.0101 and 0.0016, respectively. Compared with controls, the extra cost per quality-adjusted life year for the app group ranged from −€2425.7 to €14,870.6, which indicated greater gains in quality-adjusted life years at similar or slightly higher cost. Conclusions: The app for treating stress urinary incontinence is a new, cost-effective, first-line treatment with potential for increasing access to care in a sustainable way for this patient group. %M 28483745 %R 10.2196/jmir.7383 %U http://www.jmir.org/2017/5/e154/ %U https://doi.org/10.2196/jmir.7383 %U http://www.ncbi.nlm.nih.gov/pubmed/28483745 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 5 %P e148 %T Automated Text Messaging as an Adjunct to Cognitive Behavioral Therapy for Depression: A Clinical Trial %A Aguilera,Adrian %A Bruehlman-Senecal,Emma %A Demasi,Orianna %A Avila,Patricia %+ School of Social Welfare, University of California, Berkeley, 120 Haviland Hall, MC 7400, Berkeley, CA, 94720, United States, 1 5106428564, aguila@berkeley.edu %K depression %K text messaging %K cognitive behavioral therapy %K mhealth %K mental health %K Latinos %D 2017 %7 08.05.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Cognitive Behavioral Therapy (CBT) for depression is efficacious, but effectiveness is limited when implemented in low-income settings due to engagement difficulties including nonadherence with skill-building homework and early discontinuation of treatment. Automated messaging can be used in clinical settings to increase dosage of depression treatment and encourage sustained engagement with psychotherapy. Objectives: The aim of this study was to test whether a text messaging adjunct (mood monitoring text messages, treatment-related text messages, and a clinician dashboard to display patient data) increases engagement and improves clinical outcomes in a group CBT treatment for depression. Specifically, we aim to assess whether the text messaging adjunct led to an increase in group therapy sessions attended, an increase in duration of therapy attended, and reductions in Patient Health Questionnaire-9 item (PHQ-9) symptoms compared with the control condition of standard group CBT in a sample of low-income Spanish speaking Latino patients. Methods: Patients in an outpatient behavioral health clinic were assigned to standard group CBT for depression (control condition; n=40) or the same treatment with the addition of a text messaging adjunct (n=45). The adjunct consisted of a daily mood monitoring message, a daily message reiterating the theme of that week’s content, and medication and appointment reminders. Mood data and qualitative responses were sent to a Web-based platform (HealthySMS) for review by the therapist and displayed in session as a tool for teaching CBT skills. Results: Intent-to-treat analyses on therapy attendance during 16 sessions of weekly therapy found that patients assigned to the text messaging adjunct stayed in therapy significantly longer (median of 13.5 weeks before dropping out) than patients assigned to the control condition (median of 3 weeks before dropping out; Wilcoxon-Mann-Whitney z=−2.21, P=.03). Patients assigned to the text messaging adjunct also generally attended more sessions (median=6 sessions) during this period than patients assigned to the control condition (median =2.5 sessions), but the effect was not significant (Wilcoxon-Mann-Whitney z=−1.65, P=.10). Both patients assigned to the text messaging adjunct (B=−.29, 95% CI −0.38 to −0.19, z=−5.80, P<.001) and patients assigned to the control conditions (B=−.20, 95% CI −0.32 to −0.07, z=−3.12, P=.002) experienced significant decreases in depressive symptom severity over the course of treatment; however, the conditions did not significantly differ in their degree of symptom reduction. Conclusions: This study provides support for automated text messaging as a tool to sustain engagement in CBT for depression over time. There were no differences in depression outcomes between conditions, but this may be influenced by low follow-up rates of patients who dropped out of treatment. %M 28483742 %R 10.2196/jmir.6914 %U http://www.jmir.org/2017/5/e148/ %U https://doi.org/10.2196/jmir.6914 %U http://www.ncbi.nlm.nih.gov/pubmed/28483742 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 5 %P e155 %T The Virtual Care Climate Questionnaire: Development and Validation of a Questionnaire Measuring Perceived Support for Autonomy in a Virtual Care Setting %A Smit,Eline Suzanne %A Dima,Alexandra Lelia %A Immerzeel,Stephanie Annette Maria %A van den Putte,Bas %A Williams,Geoffrey Colin %+ Amsterdam School of Communication Research/ASCoR, Department of Communication Science, University of Amsterdam, PO Box 15791, Amsterdam, 1001 NG, Netherlands, 31 (0)6 25258558, E.S.Smit@uva.nl %K questionnaire design %K validation studies %K psychometrics %K personal autonomy %K Internet %K health behavior %K health promotion %K self-determination theory %D 2017 %7 08.05.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based health behavior change interventions may be more effective if they offer autonomy-supportive communication facilitating the internalization of motivation for health behavior change. Yet, at this moment no validated tools exist to assess user-perceived autonomy-support of such interventions. Objective: The aim of this study was to develop and validate the virtual climate care questionnaire (VCCQ), a measure of perceived autonomy-support in a virtual care setting. Methods: Items were developed based on existing questionnaires and expert consultation and were pretested among experts and target populations. The virtual climate care questionnaire was administered in relation to Web-based interventions aimed at reducing consumption of alcohol (Study 1; N=230) or cannabis (Study 2; N=228). Item properties, structural validity, and reliability were examined with item-response and classical test theory methods, and convergent and divergent validity via correlations with relevant concepts. Results: In Study 1, 20 of 23 items formed a one-dimensional scale (alpha=.97; omega=.97; H=.66; mean 4.9 [SD 1.0]; range 1-7) that met the assumptions of monotonicity and invariant item ordering. In Study 2, 16 items fitted these criteria (alpha=.92; H=.45; omega=.93; mean 4.2 [SD 1.1]; range 1-7). Only 15 items remained in the questionnaire in both studies, thus we proceeded to the analyses of the questionnaire’s reliability and construct validity with a 15-item version of the virtual climate care questionnaire. Convergent validity of the resulting 15-item virtual climate care questionnaire was confirmed by positive associations with autonomous motivation (Study 1: r=.66, P<.001; Study 2: r=.37, P<.001) and perceived competence for reducing alcohol intake (Study 1: r=.52, P<.001). Divergent validity could only be confirmed by the nonsignificant association with perceived competence for learning (Study 2: r=.05, P=.48). Conclusions: The virtual climate care questionnaire accurately assessed participants’ perceived autonomy-support offered by two Web-based health behavior change interventions. Overall, the scale showed the expected properties and relationships with relevant concepts, and the studies presented suggest this first version of the virtual climate care questionnaire to be reasonably valid and reliable. As a result, the current version may cautiously be used in future research and practice to measure perceived support for autonomy within a virtual care climate. Future research efforts are required that focus on further investigating the virtual climate care questionnaire's divergent validity, on determining the virtual climate care questionnaire’s validity and reliability when used in the context of Web-based interventions aimed at improving nonaddictive or other health behaviors, and on developing and validating a short form virtual climate care questionnaire. %M 28483743 %R 10.2196/jmir.6714 %U http://www.jmir.org/2017/5/e155/ %U https://doi.org/10.2196/jmir.6714 %U http://www.ncbi.nlm.nih.gov/pubmed/28483743 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 5 %P e144 %T Self-Management Support Using a Digital Health System Compared With Usual Care for Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial %A Farmer,Andrew %A Williams,Veronika %A Velardo,Carmelo %A Shah,Syed Ahmar %A Yu,Ly-Mee %A Rutter,Heather %A Jones,Louise %A Williams,Nicola %A Heneghan,Carl %A Price,Jonathan %A Hardinge,Maxine %A Tarassenko,Lionel %+ Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, United Kingdom, 44 1865 289280, andrew.farmer@phc.ox.ac.uk %K pulmonary disease, chronic obstructive %K telehealth %K self-care %K randomized controlled trial %D 2017 %7 03.05.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: We conducted a randomized controlled trial of a digital health system supporting clinical care through monitoring and self-management support in community-based patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Objective: The aim of this study was to determine the efficacy of a fully automated Internet-linked, tablet computer-based system of monitoring and self-management support (EDGE‚ sElf-management anD support proGrammE) in improving quality of life and clinical outcomes. Methods: We compared daily use of EDGE with usual care for 12 months. The primary outcome was COPD-specific health status measured with the St George’s Respiratory Questionnaire for COPD (SGRQ-C). Results: A total of 166 patients were randomized (110 EDGE, 56 usual care). All patients were included in an intention to treat analysis. The estimated difference in SGRQ-C at 12 months (EDGE−usual care) was −1.7 with a 95% CI of −6.6 to 3.2 (P=.49). The relative risk of hospital admission for EDGE was 0.83 (0.56-1.24, P=.37) compared with usual care. Generic health status (EQ-5D, EuroQol 5-Dimension Questionnaire) between the groups differed significantly with better health status for the EDGE group (0.076, 95% CI 0.008-0.14, P=.03). The median number of visits to general practitioners for EDGE versus usual care were 4 versus 5.5 (P=.06) and to practice nurses were 1.5 versus 2.5 (P=.03), respectively. Conclusions: The EDGE clinical trial does not provide evidence for an effect on COPD-specific health status in comparison with usual care, despite uptake of the intervention. However, there appears to be an overall benefit in generic health status; and the effect sizes for improved depression score, reductions in hospital admissions, and general practice visits warrants further evaluation and could make an important contribution to supporting people with COPD. Trial registration: International Standard Randomized Controlled Trial Number (ISRCTN): 40367841; http://www.isrctn.com/ISRCTN40367841 (Archived by WebCite at http://www.webcitation.org/6pmfIJ9KK) %M 28468749 %R 10.2196/jmir.7116 %U http://www.jmir.org/2017/5/e144/ %U https://doi.org/10.2196/jmir.7116 %U http://www.ncbi.nlm.nih.gov/pubmed/28468749 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 5 %P e119 %T Health Evaluation and Referral Assistant: A Randomized Controlled Trial of a Web-Based Screening, Brief Intervention, and Referral to Treatment System to Reduce Risky Alcohol Use Among Emergency Department Patients %A Haskins,Brianna L %A Davis-Martin,Rachel %A Abar,Beau %A Baumann,Brigitte M %A Harralson,Tina %A Boudreaux,Edwin D %+ University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA, 01655, United States, 1 5084211400, brianna.haskins@umassmed.edu %K alcohol consumption %K intervention study %K emergency medicine %K referral and consultation %D 2017 %7 01.05.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Computer technologies hold promise for implementing alcohol screening, brief intervention, and referral to treatment (SBIRT). Questions concerning the most effective and appropriate SBIRT model remain. Objective: The aim of this study was to evaluate the impact of a computerized SBIRT system called the Health Evaluation and Referral Assistant (HERA) on risky alcohol use treatment initiation. Methods: Alcohol users (N=319) presenting to an emergency department (ED) were considered for enrollment. Those enrolled (n=212) were randomly assigned to the HERA, to complete a patient-administered assessment using a tablet computer, or a minimal-treatment control, and were followed for 3 months. Analyses compared alcohol treatment provider contact, treatment initiation, treatment completion, and alcohol use across condition using univariate comparisons, generalized estimating equations (GEEs), and post hoc chi-square analyses. Results: HERA participants (n=212; control=115; intervention=97) did not differ between conditions on initial contact with an alcohol treatment provider, treatment initiation, treatment completion, or change in risky alcohol use behavior. Subanalyses indicated that HERA participants, who accepted a faxed referral, were more likely to initiate contact with a treatment provider and initiate treatment for risky alcohol use, but were not more likely to continue engaging in treatment, or to complete treatment and change risky alcohol use behavior over the 3-month period following the ED visit. Conclusions: The HERA promoted initial contact with an alcohol treatment provider and initiation of treatment for those who accepted the faxed referral, but it did not lead to reduced risky alcohol use behavior. Factors which may have limited the HERA’s impact include lack of support for the intervention by clinical staff, the low intensity of the brief and stand-alone design of the intervention, and barriers related to patient follow-through, (eg, a lack of transportation or childcare, fees for services, or schedule conflicts). Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): NCT01153373; https://clinicaltrials.gov/ct2/show/NCT01153373 (Archived by WebCite at http://www.webcitation.org/6pHQEpuIF) %M 28461283 %R 10.2196/jmir.6812 %U http://www.jmir.org/2017/5/e119/ %U https://doi.org/10.2196/jmir.6812 %U http://www.ncbi.nlm.nih.gov/pubmed/28461283 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 4 %P e138 %T Therapist-Supported Internet-Based Cognitive Behavior Therapy for Stress, Anxiety, and Depressive Symptoms Among Postpartum Women: A Systematic Review and Meta-Analysis %A Lau,Ying %A Htun,Tha Pyai %A Wong,Suei Nee %A Tam,Wai San Wilson %A Klainin-Yobas,Piyanee %+ Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 2, Clinical Research Centre, Block MD11, 10 Medical Drive, Singapore, 117597, Singapore, 65 66011603, nurly@nus.edu.sg %K Internet %K post-traumatic stress disorders %K stress %K anxiety %K depression %K cognitive behavior therapy %K meta-analysis %D 2017 %7 28.04.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: A growing number of meta-analyses have supported the application of therapist-supported Internet-based cognitive behavior therapy (iCBT) for psychological disorders across different populations, but relatively few meta-analyses have concentrated on postpartum women. Objective: This meta-analysis evaluated the efficacy of therapist-supported iCBT in improving stress, anxiety, and depressive symptoms among postpartum women. Methods: A total of 10 electronic databases were used to search for published and unpublished trials. Cochrane Collaboration tool for assessing risk of bias was utilized to measure methodological quality. Meta-analysis was performed using the RevMan software (Review Manager version 5.3 for Windows from the Nordic Cochrane Centre, the Cochrane Collaboration, 2014). Among the 789 studies identified, 8 randomized controlled trials were selected, involving 1523 participants across 6 countries. Results: More than half (65%) of the eligible studies had a low risk of bias with no heterogeneity. Results revealed that therapist-supported iCBT significantly improved stress (d=0.84, n=5), anxiety (d=0.36, n=6), and depressive symptoms (d=0.63, n=8) of the intervention group compared with those of the control group at post-intervention. Conclusions: This review revealed that therapist-supported iCBT significantly improves stress, anxiety, and depressive symptoms among postpartum women with small to large effects. Future effectiveness studies should establish the essential components, format, and approach of iCBT with optimal levels of human support to maximize a long-term effect. %M 28455276 %R 10.2196/jmir.6712 %U http://www.jmir.org/2017/4/e138/ %U https://doi.org/10.2196/jmir.6712 %U http://www.ncbi.nlm.nih.gov/pubmed/28455276 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 4 %P e124 %T Using Persuasive Technology to Increase Physical Activity in People With Chronic Obstructive Pulmonary Disease by Encouraging Regular Walking: A Mixed-Methods Study Exploring Opinions and Preferences %A Bartlett,Yvonne Kiera %A Webb,Thomas L %A Hawley,Mark S %+ Manchester Centre for Health Psychology, Manchester Academic Health Science Centre, The School of Health Sciences, University of Manchester, Coupland 1 Building, Oxford Road, Manchester, M139PL, United Kingdom, 44 161306436 ext 65436, kiera.bartlett@manchester.ac.uk %K persuasive technology %K chronic obstructive pulmonary disease %K physical activity %K walking %K mHealth %K mobile apps %D 2017 %7 20.04.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: People with chronic obstructive pulmonary disease (PwCOPD) often experience breathlessness and fatigue, making physical activity challenging. Although many persuasive technologies (such as mobile phone apps) have been designed to support physical activity among members of the general population, current technologies aimed at PwCOPD are underdeveloped and only use a limited range of persuasive technology design principles. Objective: The aim of this study was to explore how acceptable different persuasive technology design principles were considered to be in supporting and encouraging physical activity among PwCOPD. Methods: Three prototypes for mobile apps using different persuasive technology design principles as defined by the persuasive systems design (PSD) model—namely, dialogue support, primary task support, and social support—were developed. Opinions of these prototypes were explored through 28 interviews with PwCOPD, carers, and the health care professionals (HCPs) involved in their care and questionnaires completed by 87 PwCOPD. Participants also ranked how likely individual techniques (eg, competition) would be to convince them to use a technology designed to support physical activity. Data were analyzed using framework analysis, Friedman tests, and Wilcoxon signed rank tests and a convergent mixed methods design was used to integrate findings. Results: The prototypes for mobile apps were received positively by participants. The prototype that used a dialogue support approach was identified as the most likely to be used or recommended by those interviewed, and was perceived as more persuasive than both of the other prototypes (Z=−3.06, P=.002; Z=−5.50, P<.001) by those who completed the questionnaire. PwCOPD identified dialogue support and primary task support techniques as more likely to convince them to use a technology than social support techniques (Z=−5.00, P<.001; Z=−4.92, P<.001, respectively). Opinions of social support techniques such as competition and collaboration were divided. Conclusions: Dialogue support and primary task support approaches are considered to be both acceptable and likely to be persuasive by PwCOPD, carers, and HCPs. In the future, these approaches should be considered when designing apps to encourage physical activity by PwCOPD. %M 28428155 %R 10.2196/jmir.6616 %U http://www.jmir.org/2017/4/e124/ %U https://doi.org/10.2196/jmir.6616 %U http://www.ncbi.nlm.nih.gov/pubmed/28428155 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 4 %P e70 %T Mobile Phone-Delivered Cognitive Behavioral Therapy for Insomnia: A Randomized Waitlist Controlled Trial %A Horsch,Corine HG %A Lancee,Jaap %A Griffioen-Both,Fiemke %A Spruit,Sandor %A Fitrianie,Siska %A Neerincx,Mark A %A Beun,Robbert Jan %A Brinkman,Willem-Paul %+ Department of Intelligent Systems, Delft University of Technology, Mekelweg 4, Delft, 2628 CD, Netherlands, 31 152784145, corinehorsch@gmail.com %K insomnia %K smartphone app %K cognitive behavioral therapy %K eHealth %D 2017 %7 11.04.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: This study is one of the first randomized controlled trials investigating cognitive behavioral therapy for insomnia (CBT-I) delivered by a fully automated mobile phone app. Such an app can potentially increase the accessibility of insomnia treatment for the 10% of people who have insomnia. Objective: The objective of our study was to investigate the efficacy of CBT-I delivered via the Sleepcare mobile phone app, compared with a waitlist control group, in a randomized controlled trial. Methods: We recruited participants in the Netherlands with relatively mild insomnia disorder. After answering an online pretest questionnaire, they were randomly assigned to the app (n=74) or the waitlist condition (n=77). The app packaged a sleep diary, a relaxation exercise, sleep restriction exercise, and sleep hygiene and education. The app was fully automated and adjusted itself to a participant’s progress. Program duration was 6 to 7 weeks, after which participants received posttest measurements and a 3-month follow-up. The participants in the waitlist condition received the app after they completed the posttest questionnaire. The measurements consisted of questionnaires and 7-day online diaries. The questionnaires measured insomnia severity, dysfunctional beliefs about sleep, and anxiety and depression symptoms. The diary measured sleep variables such as sleep efficiency. We performed multilevel analyses to study the interaction effects between time and condition. Results: The results showed significant interaction effects (P<.01) favoring the app condition on the primary outcome measures of insomnia severity (d=–0.66) and sleep efficiency (d=0.71). Overall, these improvements were also retained in a 3-month follow-up. Conclusions: This study demonstrated the efficacy of a fully automated mobile phone app in the treatment of relatively mild insomnia. The effects were in the range of what is found for Web-based treatment in general. This supports the applicability of such technical tools in the treatment of insomnia. Future work should examine the generalizability to a more diverse population. Furthermore, the separate components of such an app should be investigated. It remains to be seen how this app can best be integrated into the current health regimens. Trial Registration: Netherlands Trial Register: NTR5560; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5560 (Archived by WebCite at http://www.webcitation.org/6noLaUdJ4) %M 28400355 %R 10.2196/jmir.6524 %U http://www.jmir.org/2017/4/e70/ %U https://doi.org/10.2196/jmir.6524 %U http://www.ncbi.nlm.nih.gov/pubmed/28400355 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 4 %P e106 %T Web-Based Intervention for Physical Activity and Fruit and Vegetable Intake Among Chinese University Students: A Randomized Controlled Trial %A Duan,Yan Ping %A Wienert,Julian %A Hu,Chun %A Si,Gang Yan %A Lippke,Sonia %+ Department of Physical Education, Faculty of Social Sciences, Hong Kong Baptist University, 12/F, Hong Kong Baptist University Shek Mun Campus, 8 On Muk Street, Shek Mun, Shatin, Hong Kong,, China (Hong Kong), 852 34113080, duanyp@hkbu.edu.hk %K Web-based intervention %K physical activity %K fruit and vegetable intake %K university students %K motivational indicators %K volitional indicators %D 2017 %7 10.04.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Ample evidence demonstrates that university students are at high risk for sedentary behaviors and inadequate fruit and vegetable intake (FVI). Internet-based interventions for multiple health behavior appear to be promising in changing such unhealthy habits. Limited randomized controlled trials have tested this assumption among Chinese university students. Objective: Our objective was to test the efficacy of an 8-week Web-based intervention compared with a control group condition to improve physical activity (PA) and FVI in Chinese university students. The intervention content was based on the health action process approach, and developed on the basis of previous evidence from the Western hemisphere. We evaluated self-reported data including PA and FVI, stages of change for PA and FVI, and motivational (risk perception, outcome expectancies, self-efficacy), volitional (action planning, coping planning, social support), and distal (intention, habit) indicators for PA and FVI, as well as perceived mental health outcomes (quality of life, depression). Methods: In a randomized controlled trial, we recruited 566 university students from one university in the central region of China during their general physical education class. After random allocation and exclusion of unsuitable participants, we assigned 493 students to 1 of 2 groups: (1) intervention group: first 4 weeks on PA and subsequent 4 weeks on FVI, (2) control group. We conducted 3 Web-based assessments: at the beginning of the intervention (T1, n=493), at the end of the 8-week intervention (T2, n=337), and at a 1-month follow-up after the intervention (T3, n=142). The entire study was conducted throughout the fall semester of 2015. Results: Significant time ⨯ group interactions revealed superior intervention effects on FVI; motivational, volitional, and distal indicators of FVI; and PA behavior changes, with an effect size (η2) ranging from .08 to .20. In addition, the overall intervention effects were significant for stage progression to the action group from T1 to T2 in PA (χ21=11.75, P=.001) and FVI (χ21=15.64, P=.03). Furthermore, the intervention effect was seen in the improvement of quality of life (F3,492=1.23, η2=.03, P=.02). Conclusions: This study provides evidence for the efficacy of a Web-based multiple health behavior intervention among Chinese university students tested with different outcome variables. Future research should address the high dropout rate and optimize the most effective components of this intervention. Trial Registration: Clinicaltrials.gov NCT01909349; https://clinicaltrials.gov/ct2/show/NCT01909349 (Archived by WebCite at http://www.webcitation.org/6pHV1A0G1) %M 28396306 %R 10.2196/jmir.7152 %U http://www.jmir.org/2017/4/e106/ %U https://doi.org/10.2196/jmir.7152 %U http://www.ncbi.nlm.nih.gov/pubmed/28396306 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 4 %P e108 %T Effect of a Nine-Month Web- and App-Based Workplace Intervention to Promote Healthy Lifestyle and Weight Loss for Employees in the Social Welfare and Health Care Sector: A Randomized Controlled Trial %A Balk-Møller,Nina Charlotte %A Poulsen,Sanne Kellebjerg %A Larsen,Thomas Meinert %+ Department of Nutrition, Exercise and Sports, Faculty of Science, Copenhagen University, Rolighedsvej 26, Frederiksberg C, 1958, Denmark, 45 27126320, nbm@nexs.ku.dk %K health promotion %K workplace %K smartphone %K weight reduction programs %K Internet %K eHealth %K randomized controlled trial %D 2017 %7 10.04.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: General health promoting campaigns are often not targeted at the people who need them the most. Web- and app-based tools are a new way to reach, motivate, and help people with poor health status. Objective: The aim of our study was to test a Web- and mobile app-based tool (“SoSu-life”) on employees in the social welfare and health care sector in Denmark. Methods: A randomized controlled trial was carried out as a workplace intervention. The tool was designed to help users make healthy lifestyle changes such as losing weight, exercise more, and quit smoking. A team competition between the participating workplaces took place during the first 16 weeks of the intervention. Twenty nursing homes for elderly people in 6 municipalities in Denmark participated in the study. The employees at the nursing homes were randomized either 1:1 or 2:1 on a municipality level to use the SoSu-life tool or to serve as a control group with no intervention. All participants underwent baseline measurements including body weight, waist circumference, body fat percentage, blood pressure, and blood cholesterol level and they filled in a questionnaire covering various aspects of health. The participants were measured again after 16 and 38 weeks. Results: A total of 566 (SoSu-life: n=355, control: n=211) participants were included in the study. At 16 weeks there were 369 participants still in the study (SoSu-life: n=227, control: n=142) and 269 participants completed the 38 week intervention (SoSu-life: n=152, control: n=117). At 38 weeks, the SoSu-life group had a larger decrease in body weight (−1.01 kg, P=.03), body fat percentage (−0.8%, P=.03), and waist circumference (−1.8 cm, P=.007) compared with the control group. Conclusions: The SoSu-life Web- and app-based tool had a modest yet beneficial effect on body weight and body fat percentage in the health care sector staff. Trial Registration: Clinicaltrials.gov NCT02438059; http://clinicaltrials.gov/ct2/show/NCT02438059 (Archived by WebCite at http://www.webcitation.org/6i6y4p2AS) %M 28396303 %R 10.2196/jmir.6196 %U http://www.jmir.org/2017/4/e108/ %U https://doi.org/10.2196/jmir.6196 %U http://www.ncbi.nlm.nih.gov/pubmed/28396303 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 4 %N 2 %P e12 %T A Mixed-Methods Study Using a Nonclinical Sample to Measure Feasibility of Ostrich Community: A Web-Based Cognitive Behavioral Therapy Program for Individuals With Debt and Associated Stress %A Smail,Dawn %A Elison,Sarah %A Dubrow-Marshall,Linda %A Thompson,Catherine %+ School of Health Sciences, University of Salford, Salford, M5 4WT, United Kingdom, 44 161 296 3486, c.thompson@salford.ac.uk %K cognitive behavioral therapy %K computer-assisted therapy %K psychological stress %K economic recession %K mental health %D 2017 %7 10.04.2017 %9 Original Paper %J JMIR Ment Health %G English %X Background: There are increasing concerns about the health and well-being of individuals facing financial troubles. For instance, in the United Kingdom, the relationship between debt and mental health difficulties is becoming more evident due to the economic downturn and welfare reform. Access to debt counseling services is limited and individuals may be reluctant to access services due to stigma. In addition, most of these services may not be appropriately resourced to address the psychological impact of debt. This study describes outcomes from an Internet-based cognitive behavioral therapy (ICBT) program, Ostrich Community (OC), which was developed to provide support to those struggling with debt and associated psychological distress. Objective: The aim of this feasibility study was to assess the suitability and acceptability of the OC program in a nonclinical sample and examine mental health and well-being outcomes from using the program. Methods: A total of 15 participants (who were not suffering from severe financial difficulty) were assisted in working through the 8-week ICBT program. Participants rated usability and satisfaction with the program, and after completion 7 participants took part in a semistructured interview to provide further feedback. Before the first session and after the final session all participants completed questionnaires to measure well-being and levels of depression, stress, and anxiety and pre- and postscores were compared. Results: Satisfaction was high and themes emerging from the interviews indicate that the program has the potential to promote effective financial behaviors and improve financial and global psychosocial well-being. When postcompletion scores were compared with those taken before the program, significant improvements were identified on psychometric measures of well-being, stress, and anxiety. Conclusions: The OC program is the first ICBT program that targets poor mental health associated with financial difficulty. This feasibility study indicates that OC may be an effective intervention for increasing financial resilience, supporting individuals to become financially independent, and promoting positive financial and global well-being. Further work with individuals suffering from debt and associated emotional difficulties will help to examine clinical effectiveness more closely. %M 28396305 %R 10.2196/mental.6809 %U http://mental.jmir.org/2017/2/e12/ %U https://doi.org/10.2196/mental.6809 %U http://www.ncbi.nlm.nih.gov/pubmed/28396305 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 4 %N 1 %P e4 %T Translating Comprehensive Conservative Care for Chronic Knee Pain Into a Digital Care Pathway: 12-Week and 6-Month Outcomes for the Hinge Health Program %A Smittenaar,Peter %A Erhart-Hledik,Jennifer C %A Kinsella,Rose %A Hunter,Simon %A Mecklenburg,Gabriel %A Perez,Daniel %+ Hinge Health Inc, 818 Mission Street, San Francisco, CA,, United States, 1 7823770826, peter@hingehealth.com %K chronic pain %K osteoarthritis, knee %K digital health %K conservative management %D 2017 %7 05.04.2017 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: Chronic knee pain (CKP) affects a large number of adults, many of whom do not receive best-practice care and are at high risk for unnecessary surgery. Objective: The aim of this study was to investigate the effect of the Hinge Health 12-week digital care program (DCP) for CKP on knee pain and function, with secondary outcomes of surgery interest and satisfaction, at 12 weeks and 6 months after starting the program. Methods: Individuals with CKP were recruited onto the 12-week program, comprising sensor-guided physical exercises, weekly education, activity tracking, and psychosocial support such as personal coaching and cognitive behavioral therapy (CBT). We used a single-arm design with assessment of outcomes at baseline, 12 weeks, and 6 months after starting the program. We used a linear mixed effects model with Tukey contrasts to compare timepoints and report intention-to-treat statistics with last observation carried forward. Results: The cohort consisted of 41 individuals (32 female, mean age 52 years, SD 9 years). Between baseline and week 12, participants reported clinically significant improvements in the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain and Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS) function scales of 16 points (95% CI 12-21, P<.001) and 10 points (95% CI 6-14, P<.001), respectively. Significant reductions of 57% (mean difference 30, 95% CI 21-38, P<.001) and 51% (mean difference 25, 95% CI 16-33, P<.001) in visual analog scale (VAS) knee pain and stiffness, respectively, were observed at 12 weeks, as well as a 67% reduction in surgery interest (mean reduction 2.3 out of 10, 95% CI 1.5-3.1, P<.001). Average satisfaction at week 12 was 9.2 out of 10. Critically, all improvements were maintained at 6 months at similar or greater magnitude. Conclusions: Participants on the Hinge Health DCP for CKP showed substantial clinical improvements that were maintained 6 months after enrolling in the program. This shows that DCPs carry strong potential to deliver evidence-based, cost-effective care to those suffering from CKP. %M 28582253 %R 10.2196/rehab.7258 %U http://rehab.jmir.org/2017/1/e4/ %U https://doi.org/10.2196/rehab.7258 %U http://www.ncbi.nlm.nih.gov/pubmed/28582253 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 5 %N 2 %P e6 %T A Blended Web-Based Gaming Intervention on Changes in Physical Activity for Overweight and Obese Employees: Influence and Usage in an Experimental Pilot Study %A Kouwenhoven-Pasmooij,Tessa A %A Robroek,Suzan JW %A Ling,Sui Wai %A van Rosmalen,Joost %A van Rossum,Elisabeth FC %A Burdorf,Alex %A Hunink,MG Myriam %+ Department of Epidemiology, Erasmus MC, University Medical Center Rotterdam, Na2818, Postbus 2040, Rotterdam, 3000CA, Netherlands, 31 107043489, t.kouwenhoven@erasmusmc.nl %K eHealth %K gamification %K physical activity %K fitness tracker %K body mass index %K engagement %K social support %K blended care %D 2017 %7 03.04.2017 %9 Original Paper %J JMIR Serious Games %G English %X Background: Addressing the obesity epidemic requires the development of effective interventions aimed at increasing physical activity (PA). eHealth interventions with the use of accelerometers and gaming elements, such as rewarding or social bonding, seem promising. These eHealth elements, blended with face-to-face contacts, have the potential to help people adopt and maintain a physically active lifestyle. Objective: The aim of this study was to assess the influence and usage of a blended Web-based gaming intervention on PA, body mass index (BMI), and waist circumference among overweight and obese employees. Methods: In an uncontrolled before-after study, we observed 52 health care employees with BMI more than 25 kg/m2, who were recruited via the company’s intranet and who voluntarily participated in a 23-week Web-based gaming intervention, supplemented (blended) with non-eHealth components. These non-eHealth components were an individual session with an occupational health physician involving motivational interviewing and 5 multidisciplinary group sessions. The game was played by teams in 5 time periods, aiming to gain points by being physically active, as measured by an accelerometer. Data were collected in 2014 and 2015. Primary outcome was PA, defined as length of time at MET (metabolic equivalent task) ≥3, as measured by the accelerometer during the game. Secondary outcomes were reductions in BMI and waist circumference, measured at baseline and 10 and 23 weeks after the start of the program. Gaming elements such as “compliance” with the game (ie, days of accelerometer wear), “engagement” with the game (ie, frequency of reaching a personal monthly target), and “eHealth teams” (ie, social influence of eHealth teams) were measured as potential determinants of the outcomes. Linear mixed models were used to evaluate the effects on all outcome measures. Results: The mean age of participants was 48.1 years; most participants were female (42/51, 82%). The mean PA was 86 minutes per day, ranging from 6.5 to 223 minutes, which was on average 26.2 minutes per day more than self-reported PA at baseline and remained fairly constant during the game. Mean BMI was reduced by 1.87 kg/m2 (5.6%) and waist circumference by 5.6 cm (4.8%). The univariable model showed that compliance, engagement, and eHealth team were significantly associated with more PA, which remained significant for eHealth team in the multivariable model. Conclusions: This blended Web-based gaming intervention was beneficial for overweight workers in becoming physically active above the recommended activity levels during the entire intervention period, and a favorable influence on BMI and waist circumference was observed. Promising components in the intervention, and thus targets for upscaling, are eHealth teams and engagement with the game. Broader implementation and long-term follow-up can provide insights into the sustainable effects on PA and weight loss and into who benefits the most from this approach. %M 28373157 %R 10.2196/games.6421 %U http://games.jmir.org/2017/2/e6/ %U https://doi.org/10.2196/games.6421 %U http://www.ncbi.nlm.nih.gov/pubmed/28373157 %0 Journal Article %I %V %N %P %T %D %7 .. %9 %J %G English %X %U %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 3 %P e87 %T Effectiveness of a Web-Based Health Education Program to Promote Oral Hygiene Care Among Stroke Survivors: Randomized Controlled Trial %A Ab Malik,Normaliza %A Mohamad Yatim,Sa'ari %A Lam,Otto Lok Tao %A Jin,Lijian %A McGrath,Colman Patrick Joseph %+ Periodontology and Dental Public Health, The University of Hong Kong, 34 Hospital Road, Hong Kong SAR,, China, 86 28590513, mcgrathc@hku.hk %K oral hygiene %K computer-aided learning %K cerebrovascular accident %K theory of planned behavior %K health care providers, Internet %D 2017 %7 31.03.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Oral hygiene care is of key importance among stroke patients to prevent complications that may compromise rehabilitation or potentially give rise to life-threatening infections such as aspiration pneumonia. Objective: The aim of this study was to evaluate the effectiveness of a Web-based continuing professional development (CPD) program on “general intention” of the health carers to perform daily mouth cleaning for stroke patients using the theory of planned behavior (TPB). Methods: A double-blind cluster randomized controlled trial was conducted among 547 stroke care providers across 10 hospitals in Malaysia. The centers were block randomized to receive either (1) test intervention (a Web-based CPD program on providing oral hygiene care to stroke patients using TPB) or (2) control intervention (a Web-based CPD program not specific to oral hygiene). Domains of TPB: “attitude,” “subjective norm” (SN), “perceived behavior control” (PBC), “general intention” (GI), and “knowledge” related to providing oral hygiene care were assessed preintervention and at 1 month and 6 months postintervention. Results: The overall response rate was 68.2% (373/547). At 1 month, between the test and control groups, there was a significant difference in changes in scores of attitude (P=.004) and subjective norm (P=.01), but not in other TPB domains (GI, P=.11; PBC, P=.51; or knowledge, P=.08). At 6 months, there were significant differences in changes in scores of GI (P=.003), attitude (P=.009), SN (P<.001) and knowledge (P=.001) between the test and control groups. Regression analyses identified that the key factors associated with a change in GI at 6 months were changes in SN (beta=.36, P<.001) and changes in PBC (beta=.23, P<.001). Conclusions: The Web-based CPD program based on TPB increased general intention, attitudes, subjective norms, and knowledge to provide oral hygiene care among stroke carers for their patients. Changing subjective norms and perceived behavioral control are key factors associated with changes in general intention to provide oral hygiene care. Trial Registration: National Medical Research Register, Malaysia NMRR-13-1540-18833 (IIR); https://www.nmrr.gov.my/ fwbLoginPage.jsp %M 28363880 %R 10.2196/jmir.7024 %U http://www.jmir.org/2017/3/e87/ %U https://doi.org/10.2196/jmir.7024 %U http://www.ncbi.nlm.nih.gov/pubmed/28363880 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 3 %P e94 %T Methodological and Ethical Challenges in a Web-Based Randomized Controlled Trial of a Domestic Violence Intervention %A Tarzia,Laura %A Valpied,Jodie %A Koziol-McLain,Jane %A Glass,Nancy %A Hegarty,Kelsey %+ Department of General Practice, The University of Melbourne, 200 Berkeley St, Carlton, 3053, Australia, 61 390358604, laura.tarzia@unimelb.edu.au %K eHealth %K domestic violence %K web-based trials %K research design %K ethics, research %D 2017 %7 28.03.2017 %9 Viewpoint %J J Med Internet Res %G English %X The use of Web-based methods to deliver and evaluate interventions is growing in popularity, particularly in a health care context. They have shown particular promise in responding to sensitive or stigmatized issues such as mental health and sexually transmitted infections. In the field of domestic violence (DV), however, the idea of delivering and evaluating interventions via the Web is still relatively new. Little is known about how to successfully navigate several challenges encountered by the researchers while working in this area. This paper uses the case study of I-DECIDE, a Web-based healthy relationship tool and safety decision aid for women experiencing DV, developed in Australia. The I-DECIDE website has recently been evaluated through a randomized controlled trial, and we outline some of the methodological and ethical challenges encountered during recruitment, retention, and evaluation. We suggest that with careful consideration of these issues, randomized controlled trials can be safely conducted via the Web in this sensitive area. %M 28351830 %R 10.2196/jmir.7039 %U http://www.jmir.org/2017/3/e94/ %U https://doi.org/10.2196/jmir.7039 %U http://www.ncbi.nlm.nih.gov/pubmed/28351830 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 3 %P e76 %T The Effect of Technology-Mediated Diabetes Prevention Interventions on Weight: A Meta-Analysis %A Bian,Rachel R %A Piatt,Gretchen A %A Sen,Ananda %A Plegue,Melissa A %A De Michele,Mariana L %A Hafez,Dina %A Czuhajewski,Christina M %A Buis,Lorraine R %A Kaufman,Neal %A Richardson,Caroline R %+ University of Michigan, Department of Family Medicine, 1018 Fuller St., Ann Arbor, MI, 48104, United States, 1 734 998 7120, caroli@umich.edu %K diabetes mellitus, type 2 %K weight reduction programs %K technology %K meta-analysis %K prediabetic state %D 2017 %7 27.03.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Lifestyle interventions targeting weight loss, such as those delivered through the Diabetes Prevention Program, reduce the risk of developing type 2 diabetes. Technology-mediated interventions may be an option to help overcome barriers to program delivery, and to disseminate diabetes prevention programs on a larger scale. Objective: We conducted a meta-analysis to evaluate the effect of such technology-mediated interventions on weight loss. Methods: In this meta-analysis, six databases were searched to identify studies reporting weight change that used technology to mediate diet and exercise interventions, and targeted individuals at high risk for developing type 2 diabetes. Studies published between January 1, 2002 and August 4, 2016 were included. Results: The search identified 1196 citations. Of those, 15 studies met the inclusion criteria and evaluated 18 technology-mediated intervention arms delivered to a total of 2774 participants. Study duration ranged from 12 weeks to 2 years. A random-effects meta-analysis showed a pooled weight loss effect of 3.76 kilograms (95% CI 2.8-4.7; P<.001) for the interventions. Several studies also reported improved glycemic control following the intervention. The small sample sizes and heterogeneity of the trials precluded an evaluation of which technology-mediated intervention method was most efficacious. Conclusions: Technology-mediated diabetes prevention programs can result in clinically significant amounts of weight loss, as well as improvements in glycaemia in patients with prediabetes. Due to their potential for large-scale implementation, these interventions will play an important role in the dissemination of diabetes prevention programs. %M 28347972 %R 10.2196/jmir.4709 %U http://www.jmir.org/2017/3/e76/ %U https://doi.org/10.2196/jmir.4709 %U http://www.ncbi.nlm.nih.gov/pubmed/28347972 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 3 %P e85 %T Assessing Feasibility and Acceptability of Web-Based Enhanced Relapse Prevention for Bipolar Disorder (ERPonline): A Randomized Controlled Trial %A Lobban,Fiona %A Dodd,Alyson L %A Sawczuk,Adam P %A Asar,Ozgur %A Dagnan,Dave %A Diggle,Peter J %A Griffiths,Martin %A Honary,Mahsa %A Knowles,Dawn %A Long,Rita %A Morriss,Richard %A Parker,Rob %A Jones,Steven %+ Spectrum Centre, Faculty of Health and Medicine, Lancaster University, Bailrigg Campus, Lancaster, LA14YT, United Kingdom, 44 01524593752, f.lobban@lancaster.ac.uk %K Internet %K randomized controlled trial %K feasibility studies %K bipolar disorder %D 2017 %7 24.03.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Interventions that teach people with bipolar disorder (BD) to recognize and respond to early warning signs (EWS) of relapse are recommended but implementation in clinical practice is poor. Objectives: The objective of this study was to test the feasibility and acceptability of a randomized controlled trial (RCT) to evaluate a Web-based enhanced relapse prevention intervention (ERPonline) and to report preliminary evidence of effectiveness. Methods: A single-blind, parallel, primarily online RCT (n=96) over 48 weeks comparing ERPonline plus usual treatment with “waitlist (WL) control” plus usual treatment for people with BD recruited through National Health Services (NHSs), voluntary organizations, and media. Randomization was independent, minimized on number of previous episodes (<8, 8-20, 21+). Primary outcomes were recruitment and retention rates, levels of intervention use, adverse events, and participant feedback. Process and clinical outcomes were assessed by telephone and Web and compared using linear models with intention-to-treat analysis. Results: A total of 280 people registered interest online, from which 96 met inclusion criteria, consented, and were randomized (49 to WL, 47 to ERPonline) over 17 months, with 80% retention in telephone and online follow-up at all time points, except at week 48 (76%). Acceptability was high for both ERPonline and trial methods. ERPonline cost approximately £19,340 to create, and £2176 per year to host and maintain the site. Qualitative data highlighted the importance of the relationship that the users have with Web-based interventions. Differences between the group means suggested that access to ERPonline was associated with: a more positive model of BD at 24 weeks (10.70, 95% CI 0.90 to 20.5) and 48 weeks (13.1, 95% CI 2.44 to 23.93); increased monitoring of EWS of depression at 48 weeks (−1.39, 95% CI −2.61 to −0.163) and of hypomania at 24 weeks (−1.72, 95% CI −2.98 to −0.47) and 48 weeks (−1.61, 95% CI −2.92 to −0.30), compared with WL. There was no evidence of impact of ERPonline on clinical outcomes or medication adherence, but relapse rates across both arms were low (15%) and the sample remained high functioning throughout. One person died by suicide before randomization and 5 people in ERPonline and 6 in WL reported ideas of suicide or self-harm. None were deemed study related by an independent Trial Steering Committee (TSC). Conclusions: ERPonline offers a cheap accessible option for people seeking ongoing support following successful treatment. However, given high functioning and low relapse rates in this study, testing clinical effectiveness for this population would require very large sample sizes. Building in human support to use ERPonline should be considered. Trial registration: International Standard Randomized Controlled Trial Number (ISRCTN): 56908625; http://www.isrctn.com/ISRCTN56908625 (Archived by WebCite at http://www.webcitation.org/6of1ON2S0) %M 28341619 %R 10.2196/jmir.7008 %U http://www.jmir.org/2017/3/e85/ %U https://doi.org/10.2196/jmir.7008 %U http://www.ncbi.nlm.nih.gov/pubmed/28341619 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 3 %P e90 %T Internet-Delivered Health Interventions That Work: Systematic Review of Meta-Analyses and Evaluation of Website Availability %A Rogers,Mary AM %A Lemmen,Kelsey %A Kramer,Rachel %A Mann,Jason %A Chopra,Vineet %+ Department of Internal Medicine, University of Michigan, Building 16, Room 422W, North Campus Research Complex, 2800 Plymouth Road, Ann Arbor, MI, 48109-2800, United States, 1 734 647 8851, maryroge@umich.edu %K Internet %K public health %K randomized controlled trial %K computer-assisted therapy %K global health %D 2017 %7 24.03.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Due to easy access and low cost, Internet-delivered therapies offer an attractive alternative to improving health. Although numerous websites contain health-related information, finding evidence-based programs (as demonstrated through randomized controlled trials, RCTs) can be challenging. We sought to bridge the divide between the knowledge gained from RCTs and communication of the results by conducting a global systematic review and analyzing the availability of evidence-based Internet health programs. Objectives: The study aimed to (1) discover the range of health-related topics that are addressed through Internet-delivered interventions, (2) generate a list of current websites used in the trials which demonstrate a health benefit, and (3) identify gaps in the research that may have hindered dissemination. Our focus was on Internet-delivered self-guided health interventions that did not require real-time clinical support. Methods: A systematic review of meta-analyses was conducted using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (PROSPERO Registration Number CRD42016041258). MEDLINE via Ovid, PsycINFO, Embase, Cochrane Database of Systematic Reviews, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) were searched. Inclusion criteria included (1) meta-analyses of RCTs, (2) at least one Internet-delivered intervention that measured a health-related outcome, and (3) use of at least one self-guided intervention. We excluded group-based therapies. There were no language restrictions. Results: Of the 363 records identified through the search, 71 meta-analyses met inclusion criteria. Within the 71 meta-analyses, there were 1733 studies that contained 268 unique RCTs which tested self-help interventions. On review of the 268 studies, 21.3% (57/268) had functional websites. These included evidence-based Web programs on substance abuse (alcohol, tobacco, cannabis), mental health (depression, anxiety, post-traumatic stress disorder [PTSD], phobias, panic disorders, obsessive compulsive disorder [OCD]), and on diet and physical activity. There were also evidence-based programs on insomnia, chronic pain, cardiovascular risk, and childhood health problems. These programs tended to be intensive, requiring weeks to months of engagement by the user, often including interaction, personalized and normative feedback, and self-monitoring. English was the most common language, although some were available in Spanish, French, Portuguese, Dutch, German, Norwegian, Finnish, Swedish, and Mandarin. There were several interventions with numbers needed to treat of <5; these included painACTION, Mental Health Online for panic disorders, Deprexis, Triple P Online (TPOL), and U Can POOP Too. Hyperlinks of the sites have been listed. Conclusions: A wide range of evidence-based Internet programs are currently available for health-related behaviors, as well as disease prevention and treatment. However, the majority of Internet-delivered health interventions found to be efficacious in RCTs do not have websites for general use. Increased efforts to provide mechanisms to host “interventions that work” on the Web and to assist the public in locating these sites are necessary. %M 28341617 %R 10.2196/jmir.7111 %U http://www.jmir.org/2017/3/e90/ %U https://doi.org/10.2196/jmir.7111 %U http://www.ncbi.nlm.nih.gov/pubmed/28341617 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 3 %P e82 %T Enlight: A Comprehensive Quality and Therapeutic Potential Evaluation Tool for Mobile and Web-Based eHealth Interventions %A Baumel,Amit %A Faber,Keren %A Mathur,Nandita %A Kane,John M %A Muench,Fred %+ Psychiatry Research, The Feinstein Institute for Medical Research, 75-59 263rd street, Glen Oaks, NY, 11004, United States, 1 7184708267, abaumel@northwell.edu %K eHealth %K mHealth %K assessment %K evaluation %K quality %K persuasive design %K behavior change %K therapeutic alliance %D 2017 %7 21.03.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Studies of criteria-based assessment tools have demonstrated the feasibility of objectively evaluating eHealth interventions independent of empirical testing. However, current tools have not included some quality constructs associated with intervention outcome, such as persuasive design, behavior change, or therapeutic alliance. In addition, the generalizability of such tools has not been explicitly examined. Objective: The aim is to introduce the development and further analysis of the Enlight suite of measures, developed to incorporate the aforementioned concepts and address generalizability aspects. Methods: As a first step, a comprehensive systematic review was performed to identify relevant quality rating criteria in line with the PRISMA statement. These criteria were then categorized to create Enlight. The second step involved testing Enlight on 42 mobile apps and 42 Web-based programs (delivery mediums) targeting modifiable behaviors related to medical illness or mental health (clinical aims). Results: A total of 476 criteria from 99 identified sources were used to build Enlight. The rating measures were divided into two sections: quality assessments and checklists. Quality assessments included usability, visual design, user engagement, content, therapeutic persuasiveness, therapeutic alliance, and general subjective evaluation. The checklists included credibility, privacy explanation, basic security, and evidence-based program ranking. The quality constructs exhibited excellent interrater reliability (intraclass correlations=.77-.98, median .91) and internal consistency (Cronbach alphas=.83-.90, median .88), with similar results when separated into delivery mediums or clinical aims. Conditional probability analysis revealed that 100% of the programs that received a score of fair or above (≥3.0) in therapeutic persuasiveness or therapeutic alliance received the same range of scores in user engagement and content—a pattern that did not appear in the opposite direction. Preliminary concurrent validity analysis pointed to positive correlations of combined quality scores with selected variables. The combined score that did not include therapeutic persuasiveness and therapeutic alliance descriptively underperformed the other combined scores. Conclusions: This paper provides empirical evidence supporting the importance of persuasive design and therapeutic alliance within the context of a program’s evaluation. Reliability metrics and preliminary concurrent validity analysis indicate the potential of Enlight in examining eHealth programs regardless of delivery mediums and clinical aims. %M 28325712 %R 10.2196/jmir.7270 %U http://www.jmir.org/2017/3/e82/ %U https://doi.org/10.2196/jmir.7270 %U http://www.ncbi.nlm.nih.gov/pubmed/28325712 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 3 %P e63 %T Online Self-Tracking Groups to Increase Fruit and Vegetable Intake: A Small-Scale Study on Mechanisms of Group Effect on Behavior Change %A Meng,Jingbo %A Peng,Wei %A Shin,Soo Yun %A Chung,Minwoong %+ Michigan State University, Department of Communication, 404 Wilson Road, CAS Building, East Lansing, MI, 48824, United States, 1 517 355 3480, jingbome@msu.edu %K online support group %K quantified self %K fruit and vegetable consumption %K social comparison %K similarity %K social modeling %D 2017 %7 06.03.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based interventions with a self-tracking component have been found to be effective in promoting adults’ fruit and vegetable consumption. However, these interventions primarily focus on individual- rather than group-based self-tracking. The rise of social media technologies enables sharing and comparing self-tracking records in a group context. Therefore, we developed an online group-based self-tracking program to promote fruit and vegetable consumption. Objective: This study aims to examine (1) the effectiveness of online group-based self-tracking on fruit and vegetable consumption and (2) characteristics of online self-tracking groups that make the group more effective in promoting fruit and vegetable consumption in early young adults. Methods: During a 4-week Web-based experiment, 111 college students self-tracked their fruit and vegetable consumption either individually (ie, the control group) or in an online group characterized by a 2 (demographic similarity: demographically similar vs demographically diverse) × 2 (social modeling: incremental change vs ideal change) experimental design. Each online group consisted of one focal participant and three confederates as group members or peers, who had their demographics and fruit and vegetable consumption manipulated to create the four intervention groups. Self-reported fruit and vegetable consumption were assessed using the Food Frequency Questionnaire at baseline and after the 4-week experiment. Results: Participants who self-tracked their fruit and vegetable consumption collectively with other group members consumed more fruits and vegetables than participants who self-tracked individually (P=.01). The results did not show significant main effects of demographic similarity (P=.32) or types of social modeling (P=.48) in making self-tracking groups more effective in promoting fruit and vegetable consumption. However, additional analyses revealed the main effect of performance discrepancy (ie, difference in fruit and vegetable consumption between a focal participant and his/her group members during the experiment), such that participants who had a low performance discrepancy from other group members had greater fruit and vegetable consumption than participants who had a high performance discrepancy from other group members (P=.002). A mediation test showed that low performance discrepancy led to greater downward contrast (b=–0.78, 95% CI –2.44 to –0.15), which in turn led to greater fruit and vegetable consumption. Conclusions: Online self-tracking groups were more effective than self-tracking alone in promoting fruit and vegetable consumption for early young adults. Low performance discrepancy from other group members lead to downward contrast, which in turn increased participants’ fruit and vegetable consumption over time. The study highlighted social comparison processes in online groups that allow for sharing personal health information. Lastly, given the small scale of this study, nonsignificant results with small effect sizes might be subject to bias. %M 28264793 %R 10.2196/jmir.6537 %U http://www.jmir.org/2017/3/e63/ %U https://doi.org/10.2196/jmir.6537 %U http://www.ncbi.nlm.nih.gov/pubmed/28264793 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 3 %N 1 %P e4 %T An eHealth Intervention to Increase Physical Activity and Healthy Eating in Older Adult Cancer Survivors: Summative Evaluation Results %A Krebs,Paul %A Shtaynberger,Jonathan %A McCabe,Mary %A Iocolano,Michelle %A Williams,Katie %A Shuk,Elyse %A Ostroff,Jamie S %+ Department of Population Health, New York University School of Medicine, Translational Research Building, 7th Floor, 227 E 30th St, New York, NY, 10016, United States, 1 646 501 2637, Paul.Krebs@nyumc.org %K survivors %K diet %K food and nutrition %K breast neoplasms %K prostatic neoplasms %K eHealth %D 2017 %7 01.03.2017 %9 Original Paper %J JMIR Cancer %G English %X Background: A healthy lifestyle is associated with improved quality of life among cancer survivors, yet adherence to health behavior recommendations is low. Objective: This pilot trial developed and tested the feasibility of a tailored eHealth program to increase fruit and vegetable consumption and physical activity among older, long-term cancer survivors. Methods: American Cancer Society (ACS) guidelines for cancer survivors were translated into an interactive, tailored health behavior program on the basis of Social Cognitive Theory. Patients (N=86) with a history of breast (n=83) or prostate cancer (n=3) and less than 5 years from active treatment were randomized 1:1 to receive either provider advice, brief counseling, and the eHealth program (intervention) or advice and counseling alone (control). Primary outcomes were self-reported fruit and vegetable intake and physical activity. Results: About half (52.7%, 86/163) of the eligible patients consented to participate. The most common refusal reasons were lack of perceived time for the study (32/163) and lack of interest in changing health behaviors (29/163). Furthermore, 72% (23/32) of the intervention group reported using the program and most would recommend it to others (56%, 14/25). Qualitative results indicated that the intervention was highly acceptable for survivors. For behavioral outcomes, the intervention group reported increased fruit and vegetable consumption. Self-reported physical activity declined in both groups. Conclusions: The brief intervention showed promising results for increasing fruit and vegetable intake. Results and participant feedback suggest that providing the intervention in a mobile format with greater frequency of contact and more indepth information would strengthen treatment effects. %M 28410171 %R 10.2196/cancer.6435 %U http://cancer.jmir.org/2017/1/e4/ %U https://doi.org/10.2196/cancer.6435 %U http://www.ncbi.nlm.nih.gov/pubmed/28410171 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 2 %P e43 %T A Web-Based Physical Activity Intervention for Spanish-Speaking Latinas: A Costs and Cost-Effectiveness Analysis %A Larsen,Britta %A Marcus,Bess %A Pekmezi,Dori %A Hartman,Sheri %A Gilmer,Todd %+ University of California, San Diego, Department of Family Medicine and Public Health, 9500 Gilman Drive, La Jolla, CA, 92093-0628, United States, 1 8585348363, blarsen@ucsd.edu %K cost-effectiveness %K physical activity %K Latinos %K Latinas %K Web-based interventions %K health disparities %D 2017 %7 22.02.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Latinas report particularly low levels of physical activity and suffer from greater rates of lifestyle-related conditions such as obesity and diabetes. Interventions are needed that can increase physical activity in this growing population in a large-scale, cost-effective manner. Web-based interventions may have potential given the increase in Internet use among Latinas and the scalability of Web-based programs. Objective: To examine the costs and cost-effectiveness of a Web-based, Spanish-language physical activity intervention for Latinas compared to a wellness contact control. Methods: Healthy adult Latina women (N=205) were recruited from the community and randomly assigned to receive a Spanish-language, Web-based, individually tailored physical activity intervention (intervention group) or were given access to a website with content on wellness topics other than physical activity (control group). Physical activity was measured using the 7-Day Physical Activity Recall interview and ActiGraph accelerometers at baseline, 6 months (ie, postintervention), and 12 months (ie, maintenance phase). Costs were estimated from a payer perspective and included all features necessary to implement the intervention in a community setting, including staff time (ie, wages, benefits, and overhead), materials, hardware, website hosting, and routine website maintenance. Results: At 6 months, the costs of running the intervention and control groups were US $17 and US $8 per person per month, respectively. These costs fell to US $12 and US $6 per person per month at 12 months, respectively. Linear interpolation showed that intervention participants increased their physical activity by 1362 total minutes at 6 months (523 minutes by accelerometer) compared to 715 minutes for control participants (186 minutes by accelerometer). At 6 months, each minute increase in physical activity for the intervention group cost US $0.08 (US $0.20 by accelerometer) compared to US $0.07 for control participants (US $0.26 by accelerometer). Incremental cost-per-minute increases associated with the intervention were US $0.08 at 6 months and US $0.04 at 12 months (US $0.16 and US $0.08 by accelerometer, respectively). Sensitivity analyses showed variations in staffing costs or intervention effectiveness yielded only modest changes in incremental costs. Conclusions: While the Web-based physical activity intervention was more expensive than the wellness control, both were quite low cost compared to face-to-face or mail-delivered interventions. Cost-effectiveness ranged markedly based on physical activity measure and was similar between the two conditions. Overall, the Web-based intervention was effective and low cost, suggesting a promising channel for increasing physical activity on a large scale in this at-risk population. ClinicalTrial: Clinicaltrials.gov NCT01834287; https://clinicaltrials.gov/ct2/show/NCT01834287 (Archived by WebCite at http://www.webcitation.org/6nyjX9Jrh) %M 28228368 %R 10.2196/jmir.6257 %U http://www.jmir.org/2017/2/e43/ %U https://doi.org/10.2196/jmir.6257 %U http://www.ncbi.nlm.nih.gov/pubmed/28228368 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 2 %P e32 %T The Benefit of Web- and Computer-Based Interventions for Stress: A Systematic Review and Meta-Analysis %A Heber,Elena %A Ebert,David Daniel %A Lehr,Dirk %A Cuijpers,Pim %A Berking,Matthias %A Nobis,Stephanie %A Riper,Heleen %+ Department of Health Psychology and Applied Biological Psychology, Institute of Psychology, Leuphana University Lueneburg, Scharnhorststr 1, Lueneburg, 21335, Germany, 49 4131 677 ext 2720, heber@leuphana.de %K stress %K mental health %K internet-based interventions %K review %K randomized controlled trial %K meta-analysis %D 2017 %7 17.02.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Stress has been identified as one of the major public health issues in this century. New technologies offer opportunities to provide effective psychological interventions on a large scale. Objective: The aim of this study is to investigate the efficacy of Web- and computer-based stress-management interventions in adults relative to a control group. Methods: A meta-analysis was performed, including 26 comparisons (n=4226). Cohen d was calculated for the primary outcome level of stress to determine the difference between the intervention and control groups at posttest. Analyses of the effect on depression, anxiety, and stress in the following subgroups were also conducted: risk of bias, theoretical basis, guidance, and length of the intervention. Available follow-up data (1-3 months, 4-6 months) were assessed for the primary outcome stress. Results: The overall mean effect size for stress at posttest was Cohen d=0.43 (95% CI 0.31-0.54). Significant, small effects were found for depression (Cohen d=0.34, 95% CI 0.21-0.48) and anxiety (Cohen d=0.32, 95% CI 0.17-0.47). Subgroup analyses revealed that guided interventions (Cohen d=0.64, 95% CI 0.50-0.79) were more effective than unguided interventions (Cohen d=0.33, 95% CI 0.20-0.46; P=.002). With regard to the length of the intervention, short interventions (≤4 weeks) showed a small effect size (Cohen d=0.33, 95% CI 0.22-0.44) and medium-long interventions (5-8 weeks) were moderately effective (Cohen d=0.59; 95% CI 0.45-0.74), whereas long interventions (≥9 weeks) produced a nonsignificant effect (Cohen d=0.21, 95% CI –0.05 to 0.47; P=.006). In terms of treatment type, interventions based on cognitive behavioral therapy (CBT) and third-wave CBT (TWC) showed small-to-moderate effect sizes (CBT: Cohen d=0.40, 95% CI 0.19-0.61; TWC: Cohen d=0.53, 95% CI 0.35-0.71), and alternative interventions produced a small effect size (Cohen d=0.24, 95% CI 0.12-0.36; P=.03). Early evidence on follow-up data indicates that Web- and computer-based stress-management interventions can sustain their effects in terms of stress reduction in a small-to-moderate range up to 6 months. Conclusions: These results provide evidence that Web- and computer-based stress-management interventions can be effective and have the potential to reduce stress-related mental health problems on a large scale. %M 28213341 %R 10.2196/jmir.5774 %U http://www.jmir.org/2017/2/e32/ %U https://doi.org/10.2196/jmir.5774 %U http://www.ncbi.nlm.nih.gov/pubmed/28213341 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 2 %P e44 %T From the Experience of Interactivity and Entertainment to Lower Intention to Smoke: A Randomized Controlled Trial and Path Analysis of a Web-Based Smoking Prevention Program for Adolescents %A Khalil,Georges Elias %A Wang,Hua %A Calabro,Karen Sue %A Mitra,Natasha %A Shegog,Ross %A Prokhorov,Alexander V %+ MD Anderson Cancer Center, Department of Behavioral Sciences, University of Texas, 1155 Pressler St. Unit 1330, Houston, TX, 77030, United States, 1 7137452382, aprokhor@mdanderson.org %K smoking prevention %K intention to smoke %K adolescent %K Web-based intervention %K interactivity %K entertainment %K emotions %K presence %K experience %D 2017 %7 16.02.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based programs for smoking prevention are being increasingly used with some success among adolescents. However, little is known about the mechanisms that link the experience of such programs to intended nicotine or tobacco control outcomes. Objective: Based on the experiential learning theory and extended elaboration likelihood model, this study aimed to evaluate the impact of a Web-based intervention, A Smoking Prevention Interactive Experience (ASPIRE), on adolescents’ intention to smoke, while considering the experience of interactivity and entertainment as predictors of reduced intention to smoke, under a transitional user experience model. Methods: A total of 101 adolescents were recruited from after-school programs, provided consent, screened, and randomized in a single-blinded format to 1 of 2 conditions: the full ASPIRE program as the experimental condition (n=50) or an online , text-based version of ASPIRE as the control condition (n=51). Data were collected at baseline and immediate follow-up. Repeated-measures mixed-effects models and path analyses were conducted. Results: A total of 82 participants completed the study and were included in the analysis. Participants in the experimental condition were more likely to show a decrease in their intention to smoke than those in the control condition (beta=−0.18, P=.008). Perceived interactivity (beta=−0.27, P=.004) and entertainment (beta=−0.20, P=.04) were each associated with a decrease in intention to smoke independently. Results of path analyses indicated that perceived interactivity and perceived entertainment mediated the relationship between ASPIRE use and emotional involvement. Furthermore, perceived presence mediated the relationship between perceived interactivity and emotional involvement. There was a direct relationship between perceived entertainment and emotional involvement. Emotional involvement predicted a decrease in intention to smoke (beta=−0.16, P=.04). Conclusions: Adolescents’ experience of interactivity and entertainment contributed to the expected outcome of lower intention to smoke. Also, emphasis needs to be placed on the emotional experience during Web-based interventions in order to maximize reductions in smoking intentions. Going beyond mere evaluation of the effectiveness of a Web-based smoking prevention program, this study contributes to the understanding of adolescents’ psychological experience and its effect on their intention to smoke. With the results of this study, researchers can work to (1) enhance the experience of interactivity and entertainment and (2) amplify concepts of media effects (eg, presence and emotional involvement) in order to better reach health behavior outcomes. Trial Registration: Clinicaltrials.gov NCT02469779; https://clinicaltrials.gov/ct2/show/NCT02469779 (Archived by WebCite at http://www.webcitation.org/6nxyZVOf0) %M 28209560 %R 10.2196/jmir.7174 %U http://www.jmir.org/2017/2/e44/ %U https://doi.org/10.2196/jmir.7174 %U http://www.ncbi.nlm.nih.gov/pubmed/28209560 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 2 %P e28 %T Barriers to Remote Health Interventions for Type 2 Diabetes: A Systematic Review and Proposed Classification Scheme %A Alvarado,Michelle M %A Kum,Hye-Chung %A Gonzalez Coronado,Karla %A Foster,Margaret J %A Ortega,Pearl %A Lawley,Mark A %+ Department of Industrial and Systems Engineering, Texas A&M University, 3131 TAMU, College Station, TX, 77843, United States, 1 979 458 2350, michelle.alvarado@tamu.edu %K diabetes mellitus, type 2 %K early medical intervention %K biomedical technology %K remote sensing technology %K terminology as topic %D 2017 %7 13.02.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Diabetes self-management involves adherence to healthy daily habits typically involving blood glucose monitoring, medication, exercise, and diet. To support self-management, some providers have begun testing remote interventions for monitoring and assisting patients between clinic visits. Although some studies have shown success, there are barriers to widespread adoption. Objective: The objective of our study was to identify and classify barriers to adoption of remote health for management of type 2 diabetes. Methods: The following 6 electronic databases were searched for articles published from 2010 to 2015: MEDLINE (Ovid), Embase (Ovid), CINAHL, Cochrane Central, Northern Light Life Sciences Conference Abstracts, and Scopus (Elsevier). The search identified studies involving remote technologies for type 2 diabetes self-management. Reviewers worked in teams of 2 to review and extract data from identified papers. Information collected included study characteristics, outcomes, dropout rates, technologies used, and barriers identified. Results: A total of 53 publications on 41 studies met the specified criteria. Lack of data accuracy due to input bias (32%, 13/41), limitations on scalability (24%, 10/41), and technology illiteracy (24%, 10/41) were the most commonly cited barriers. Technology illiteracy was most prominent in low-income populations, whereas limitations on scalability were more prominent in mid-income populations. Barriers identified were applied to a conceptual model of successful remote health, which includes patient engagement, patient technology accessibility, quality of care, system technology cost, and provider productivity. In total, 40.5% (60/148) of identified barrier instances impeded patient engagement, which is manifest in the large dropout rates cited (up to 57%). Conclusions: The barriers identified represent major challenges in the design of remote health interventions for diabetes. Breakthrough technologies and systems are needed to alleviate the barriers identified so far, particularly those associated with patient engagement. Monitoring devices that provide objective and reliable data streams on medication, exercise, diet, and glucose monitoring will be essential for widespread effectiveness. Additional work is needed to understand root causes of high dropout rates, and new interventions are needed to identify and assist those at the greatest risk of dropout. Finally, future studies must quantify costs and benefits to determine financial sustainability. %M 28193598 %R 10.2196/jmir.6382 %U http://www.jmir.org/2017/2/e28/ %U https://doi.org/10.2196/jmir.6382 %U http://www.ncbi.nlm.nih.gov/pubmed/28193598 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 2 %P e36 %T An Online Intervention Comparing a Very Low-Carbohydrate Ketogenic Diet and Lifestyle Recommendations Versus a Plate Method Diet in Overweight Individuals With Type 2 Diabetes: A Randomized Controlled Trial %A Saslow,Laura R %A Mason,Ashley E %A Kim,Sarah %A Goldman,Veronica %A Ploutz-Snyder,Robert %A Bayandorian,Hovig %A Daubenmier,Jennifer %A Hecht,Frederick M %A Moskowitz,Judith T %+ Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Room 2178, 400 N Ingalls St, Ann Arbor, MI, 48105, United States, 1 734 764 7836, saslowl@umich.edu %K eHealth %K diet %K weight loss %K type 2 diabetes mellitus %D 2017 %7 13.02.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Type 2 diabetes is a prevalent, chronic disease for which diet is an integral aspect of treatment. In our previous trial, we found that recommendations to follow a very low-carbohydrate ketogenic diet and to change lifestyle factors (physical activity, sleep, positive affect, mindfulness) helped overweight people with type 2 diabetes or prediabetes improve glycemic control and lose weight. This was an in-person intervention, which could be a barrier for people without the time, flexibility, transportation, social support, and/or financial resources to attend. Objective: The aim was to determine whether an online intervention based on our previous recommendations (an ad libitum very low-carbohydrate ketogenic diet with lifestyle factors; “intervention”) or an online diet program based on the American Diabetes Associations’ “Create Your Plate” diet (“control”) would improve glycemic control and other health outcomes among overweight individuals with type 2 diabetes. Methods: In this pilot feasibility study, we randomized overweight adults (body mass index ≥25) with type 2 diabetes (glycated hemoglobin [HbA1c] 6.5%-9.0%) to a 32-week online intervention based on our previous recommendations (n=12) or an online diet program based around a plate method diet (n=13) to assess the impact of each intervention on glycemic control and other health outcomes. Primary and secondary outcomes were analyzed by mixed-effects linear regression to compare outcomes by group. Results: At 32 weeks, participants in the intervention group reduced their HbA1c levels more (estimated marginal mean [EMM] –0.8%, 95% CI –1.1% to –0.6%) than participants in the control group (EMM –0.3%, 95% CI –0.6% to 0.0%; P=.002). More than half of the participants in the intervention group (6/11, 55%) lowered their HbA1c to less than 6.5% versus 0% (0/8) in the control group (P=.02). Participants in the intervention group lost more weight (EMM –12.7 kg, 95% CI –16.1 to –9.2 kg) than participants in the control group (EMM –3.0 kg, 95% CI –7.3 to 1.3 kg; P<.001). A greater percentage of participants lost at least 5% of their body weight in the intervention (10/11, 90%) versus the control group (2/8, 29%; P=.01). Participants in the intervention group lowered their triglyceride levels (EMM –60.1 mg/dL, 95% CI –91.3 to –28.9 mg/dL) more than participants in the control group (EMM –6.2 mg/dL, 95% CI –46.0 to 33.6 mg/dL; P=.01). Dropout was 8% (1/12) and 46% (6/13) for the intervention and control groups, respectively (P=.07). Conclusions: Individuals with type 2 diabetes improved their glycemic control and lost more weight after being randomized to a very low-carbohydrate ketogenic diet and lifestyle online program rather than a conventional, low-fat diabetes diet online program. Thus, the online delivery of these very low-carbohydrate ketogenic diet and lifestyle recommendations may allow them to have a wider reach in the successful self-management of type 2 diabetes. Trial Registration: ClinicalTrials.gov NCT01967992; https://clinicaltrials.gov/ct2/show/NCT01967992 (Archived by WebCite at http://www.webcitation.org/6o0fI9Mkq) %M 28193599 %R 10.2196/jmir.5806 %U http://www.jmir.org/2017/2/e36/ %U https://doi.org/10.2196/jmir.5806 %U http://www.ncbi.nlm.nih.gov/pubmed/28193599 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 2 %P e37 %T Commencing and Persisting With a Web-Based Cognitive Behavioral Intervention for Insomnia: A Qualitative Study of Treatment Completers %A Chan,Charles %A West,Stacey %A Glozier,Nick %+ Brain and Mind Centre, University of Sydney, Professor Marie Bashir Centre Level 5, Building 11 RPAH 67-73 Missenden Road, Camperdown, 2050, Australia, 61 02 9966 7408, sccchan@gmail.com %K adherence %K persistence %K eHealth %K online intervention %K Web-based intervention %K motivations %K barriers %K insomnia %K depression %K men %D 2017 %7 10.02.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Computerized cognitive behavioral therapy for insomnia (CCBT-I) has a growing evidence base as a stand-alone intervention, but it is less clear what factors may limit its acceptability and feasibility when combined with clinical care. Objective: The purpose of this study was to explore barriers and facilitators to use of an adjunctive CCBT-I program among depressed patients in a psychiatric clinic by using both quantitative and qualitative approaches. Methods: We conducted the qualitative component of the study using face-to-face or telephone interviews with participants who had enrolled in a clinical trial of a CCBT-I program as an adjunctive treatment in a psychiatric clinical setting. In line with the grounded theory approach, we used a semistructured interview guide with new thematic questions being formulated during the transcription and data analysis, as well as being added to the interview schedule. A range of open and closed questions addressing user experience were asked of all study participants who completed the 12-week trial in an online survey. Results: Three themes emerged from the interviews and open questions, consistent with nonadjunctive CCBT-I implementation. Identification with the adjunctive intervention’s target symptom of insomnia and the clinical setting were seen as key reasons to engage initially. Persistence was related to factors to do with the program, its structure, and its content, rather than any nonclinical factors. The survey results showed that only the key active behavioral intervention, sleep restriction, was rated as a major problem by more than 15% of the sample. In this clinical setting, the support of the clinician in completing the unsupported program was highlighted, as was the need for the program and clinical treatment to be coordinated. Conclusions: The use of a normally unsupported CCBT-I program as an adjunctive treatment can be aided by the clinician’s approach. A key behavioral component of the intervention, specific to insomnia treatment, was identified as a major problem for persistence. As such, clinicians need to be aware of when such components are delivered in the program and coordinate their care accordingly, if the use of the program is to be optimized. ClinicalTrial: Australian and New Zealand Clinical Trials Registry ACTRN12612000985886; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362875&isReview=true (Archived by WebCite at http://www.webcitation.org/6njjhl42X) %M 28188124 %R 10.2196/jmir.5639 %U http://www.jmir.org/2017/2/e37/ %U https://doi.org/10.2196/jmir.5639 %U http://www.ncbi.nlm.nih.gov/pubmed/28188124 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 2 %P e8 %T Weight Loss Associated With Different Patterns of Self-Monitoring Using the Mobile Phone App My Meal Mate %A Carter,Michelle C %A Burley,Victoria J %A Cade,Janet E %+ Nutritional Epidemiology Group, School of Food Science and Nutrition, University of Leeds, Stead House, Leeds, LS29 7QH, United Kingdom, 44 1133436946, j.e.cade@leeds.ac.uk %K self-monitoring %K mobile phone %K obesity %K weight loss %D 2017 %7 02.02.2017 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Obesity is a major global public health issue due to its association with a number of serious chronic illnesses and its high economic burden to health care providers. Self-monitoring of diet has been consistently linked to weight loss. However, there is limited evidence about how frequently individuals need to monitor their diet for optimal weight loss. Objective: The aim of this paper is to describe app usage frequency and pattern in the mobile phone arm of a previously conducted randomized controlled trial. The relationship between frequency and pattern of electronic dietary self-monitoring and weight loss is also investigated. Methods: A randomized pilot trial comparing three methods of self-monitoring (mobile phone app, paper diary, Web-based) was previously conducted. Trial duration was 6 months. The mobile phone app My Meal Mate features an electronic food diary and encourages users to self-monitor their dietary intake. All food consumption data were automatically uploaded with a time and date stamp. Post hoc regression analysis of app usage patterns was undertaken in the My Meal Mate group (n=43; female: 77%, 33/43; white: 100%, 43/43; age: mean 41, SD 9 years; body mass index: mean 34, SD 4 kg/m2) to explore the relationship between frequency and pattern of electronic dietary self-monitoring and weight loss. Baseline characteristics of participants were also investigated to identify any potential predictors of dietary self-monitoring. Results: Regression analysis showed that those in the highest frequency-of-use category (recorded ≥129 days on the mobile phone app) had a −6.4 kg (95% CI −10.0 to −2.9) lower follow-up weight (adjusted for baseline weight) than those in the lowest frequency-of-use category (recorded ≤42 days; P<.001). Long-term intermittent monitoring over 6 months appeared to facilitate greater mean weight loss than other patterns of electronic self-monitoring (ie, monitoring over the short or moderate term and stopping and consistently monitoring over consecutive days). Participant characteristics such as age, baseline weight, sex, ethnicity, conscientiousness, and consideration of future consequences were not statistically associated with extent of self-monitoring. Conclusions: The results of this post hoc exploratory analysis indicate that duration and frequency of app use is associated with improved weight loss, but further research is required to identify whether there are participant characteristics that would reliably predict those who are most likely to regularly self-monitor their diet. ClinicalTrial: ClinicalTrials.gov NCT01744535; http://clinicaltrials.gov/ct2/show/NCT01744535 (Archived by WebCite at http://www.webcitation.org/6FEtc3PVB) %M 28153814 %R 10.2196/mhealth.4520 %U http://mhealth.jmir.org/2017/2/e8/ %U https://doi.org/10.2196/mhealth.4520 %U http://www.ncbi.nlm.nih.gov/pubmed/28153814 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 1 %P e21 %T Effects on Engagement and Health Literacy Outcomes of Web-Based Materials Promoting Physical Activity in People With Diabetes: An International Randomized Trial %A Muller,Ingrid %A Rowsell,Alison %A Stuart,Beth %A Hayter,Victoria %A Little,Paul %A Ganahl,Kristin %A Müller,Gabriele %A Doyle,Gerardine %A Chang,Peter %A Lyles,Courtney R %A Nutbeam,Don %A Yardley,Lucy %+ Department of Psychology, University of Southampton, Highfield campus, Southampton, SO17 1BJ, United Kingdom, 44 02380 592581, I.Muller@soton.ac.uk %K health literacy %K digital intervention %K diabetes %K quantitative trial %K physical activity %D 2017 %7 23.01.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Developing accessible Web-based materials to support diabetes self-management in people with lower levels of health literacy is a continuing challenge. Objective: The objective of this international study was to develop a Web-based intervention promoting physical activity among people with type 2 diabetes to determine whether audiovisual presentation and interactivity (quizzes, planners, tailoring) could help to overcome the digital divide by making digital interventions accessible and effective for people with all levels of health literacy. This study also aimed to determine whether these materials can improve health literacy outcomes for people with lower levels of health literacy and also be effective for people with higher levels of health literacy. Methods: To assess the impact of interactivity and audiovisual features on usage, engagement, and health literacy outcomes, we designed two versions of a Web-based intervention (one interactive and one plain-text version of the same content) to promote physical activity in people with type 2 diabetes. We randomly assigned participants from the United Kingdom, Austria, Germany, Ireland, and Taiwan to either an interactive or plain-text version of the intervention in English, German, or Mandarin. Intervention usage was objectively recorded by the intervention software. Self-report measures were taken at baseline and follow-up (immediately after participants viewed the intervention) and included measures of health literacy, engagement (website satisfaction and willingness to recommend the intervention to others), and health literacy outcomes (diabetes knowledge, enablement, attitude, perceived behavioral control, and intention to undertake physical activity). Results: In total, 1041 people took part in this study. Of the 1005 who completed health literacy information, 268 (26.67%) had intermediate or low levels of health literacy. The interactive intervention overall did not produce better outcomes than did the plain-text version. Participants in the plain-text intervention group looked at significantly more sections of the intervention (mean difference –0.47, 95% CI –0.64 to –0.30, P<.001), but this did not lead to better outcomes. Health literacy outcomes, including attitudes and intentions to engage in physical activity, significantly improved following the intervention for participants in both intervention groups. These improvements were similar across higher and lower health literacy levels and in all countries. Participants in the interactive intervention group had acquired more diabetes knowledge (mean difference 0.80, 95% CI 0.65-0.94, P<.001). Participants from both groups reported high levels of website satisfaction and would recommend the website to others. Conclusions: Following established practice for simple, clear design and presentation and using a person-based approach to intervention development, with in-depth iterative feedback from users, may be more important than interactivity and audiovisual presentations when developing accessible digital health interventions to improve health literacy outcomes. ClinicalTrial: International Standard Randomized Controlled Trial Number (ISRCTN): 43587048; http://www.isrctn.com/ISRCTN43587048. (Archived by WebCite at http://www.webcitation.org/6nGhaP9bv) %M 28115299 %R 10.2196/jmir.6601 %U http://www.jmir.org/2017/1/e21/ %U https://doi.org/10.2196/jmir.6601 %U http://www.ncbi.nlm.nih.gov/pubmed/28115299 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 1 %P e22 %T It’s About Me: Patients’ Experiences of Patient Participation in the Web Behavior Change Program for Activity in Combination With Multimodal Pain Rehabilitation %A Nordin,Catharina %A Michaelson,Peter %A Eriksson,Margareta K %A Gard,Gunvor %+ Department of Primary Health Care, Region Norrbotten, Piteå hälsocentral, Prästgårdsgatan 40, Piteå, 94132, Sweden, 46 702420906, catharina.nordin@norrbotten.se %K interview %K pain %K patient participation %K qualitative research %K Web-based intervention %D 2017 %7 18.01.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Patients’ participation in their health care is recognized as a key component in high-quality health care. Persons with persistent pain are recommended treatments with a cognitive approach from a biopsychosocial explanation of pain, in which a patient’s active participation in their rehabilitation is in focus. Web-based interventions for pain management have the potential to increase patient participation by enabling persons to play a more active role in rehabilitation. However, little is known about patients’ experiences of patient participation in Web-based interventions in clinical practice. Objective: The objective of our study was to explore patients’ experiences of patient participation in a Web Behavior Change Program for Activity (Web-BCPA) in combination with multimodal rehabilitation (MMR) among patients with persistent pain in primary health care. Methods: Qualitative interviews were conducted with 15 women and 4 men, with a mean age of 45 years. Data were analyzed with qualitative content analysis. Results: One theme, “It’s about me,” and 4 categories, “Take part in a flexible framework of own priority,” “Acquire knowledge and insights,” “Ways toward change,” and “Personal and environmental conditions influencing participation,” were developed. Patient participation was depicted as being confirmed in an individualized and structured rehabilitation framework of one’s own choice. Being confirmed was fundamental to patient participation in the interaction with the Web-BCPA and with the health care professionals in MMR. To acquire knowledge and insights about pain and their life situation, through self-reflection in the solitary work in the Web-BCPA and through feedback from the health care professionals in MMR, was experienced as patient participation by the participants. Patient participation was described as structured ways to reach their goals of behavior change, which included analyzing resources and restrictions, problem solving, and evaluation. The individual’s emotional and cognitive resources and restrictions, as well as health care professionals and significant others’ attitudes and behavior influenced patient participation in the rehabilitation. To some extent there were experiences of restrained patient participation through the great content of the Web-BCPA. Conclusions: Patient participation was satisfactory in the Web-BCPA in combination with MMR. The combined treatment was experienced to increase patient participation in the rehabilitation. Being confirmed through self-identification and finding the content of the Web-BCPA trustworthy was emphasized. Patient participation was experienced as a learning process leading to new knowledge and insights. Higher user control regarding the timing of the Web-BCPA and therapist guidance of the content may further increase patient participation in the combined treatment. %M 28100440 %R 10.2196/jmir.5970 %U http://www.jmir.org/2017/1/e22/ %U https://doi.org/10.2196/jmir.5970 %U http://www.ncbi.nlm.nih.gov/pubmed/28100440 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 2 %N 1 %P e1 %T The Case for Jointly Targeting Diabetes and Depression Among Vulnerable Patients Using Digital Technology %A Aguilera,Adrian %A Lyles,Courtney Rees %+ School of Social Welfare, University of California, Berkeley, 120 Haviland Hall, MC 7400, Berkeley, CA,, United States, 1 510 642 8564, aguila@berkeley.edu %K diabetes %K depression %K chronic illness %K digital health %K vulnerable populations %D 2017 %7 17.01.2017 %9 Viewpoint %J JMIR Diabetes %G English %X It is well publicized that mobile and digital technologies hold great promise to improve health outcomes among patients with chronic illnesses such as diabetes. However, there is growing concern that digital health investments (both from federal research dollars and private venture investments) have not yet resulted in tangible health improvements. We see three major reasons for this limited real-world impact on health outcomes: (1) lack of solutions relevant for patients with multiple comorbidities or conditions, (2) lack of diverse patient populations involved in the design and early testing of products, and (3) inability to leverage existing clinical workflows to improve both patient enrollment and engagement in technology use. We discuss each of these in depth, followed by new research directions to increase effectiveness in this field. %M 30291080 %R 10.2196/diabetes.6916 %U http://diabetes.jmir.org/2017/1/e1/ %U https://doi.org/10.2196/diabetes.6916 %U http://www.ncbi.nlm.nih.gov/pubmed/30291080 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 1 %P e16 %T Developing Nutrition Label Reading Skills: A Web-Based Practice Approach %A Miller,Lisa M Soederberg %A Beckett,Laurel A %A Bergman,Jacqueline J %A Wilson,Machelle D %A Applegate,Elizabeth A %A Gibson,Tanja N %+ Department of Human Ecology, University of California, Davis, One Shields Ave, Davis, CA, 95616, United States, 1 530 752 3955, lmsmiller@ucdavis.edu %K nutrition labeling %K dietary habits %K automatic information processing %K food selection %K choice behavior %D 2017 %7 13.01.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Nutrition labels offer the information needed to follow Dietary Guidelines for Americans, yet many individuals use labels infrequently or ineffectively due to limited comprehension and the effort required to use them. Objective: The objective of our study was to develop and test a Web-based label-reading training tool to improve individuals’ ability to use labels to select more healthful foods. We were particularly interested in determining whether practice can lead to increased accuracy using labels as well as decreased effort, together reflecting greater efficiency. We compared a basic and an enhanced, prior-knowledge version of the tool that contained an additional component, a brief nutrition tutorial. Methods: Participants were 140 college students with an average age of 20.7 (SD 2.1) years and education 14.6 (SD 1.2) years, who completed 3 sets of practice that were designed to teach them, through repetition and feedback, how to use nutrition labels to select more healthful products. Prior to training, participants in the prior-knowledge group viewed a multimedia nutrition presentation, which those in the basic group did not receive. Mixed-effects models tested for improvement in accuracy and speed with practice, and whether improvements varied by group. Results: The training led to significant increases in average accuracy across the 3 practice sets (averaging 79% [19/24 questions], 92% [22/24], 96% [23/24] respectively, P<.001), as well as decreases in time to complete with mean (SD) values of 8.7 (2.8), 4.6 (1.8), and 4.1 (1.7) seconds, respectively. In block 3, the odds of a correct answer for the prior-knowledge group were 79% higher (odds ratio, OR=1.79, 95% CI 1.1-2.9) than those for the basic group (P=.02). There was no significant difference between the groups in block 2 (P=.89). Conclusions: Practice led to improvements in nutrition label reading skills that are indicative of early stages of automatic processing. To the extent that automatic processes are at the core of healthy habit change, this may be an efficient way to improve dietary decision-making. %M 28087497 %R 10.2196/jmir.6583 %U http://www.jmir.org/2017/1/e16/ %U https://doi.org/10.2196/jmir.6583 %U http://www.ncbi.nlm.nih.gov/pubmed/28087497 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 1 %P e6 %T Does Usage of an eHealth Intervention Reduce the Risk of Excessive Gestational Weight Gain? Secondary Analysis From a Randomized Controlled Trial %A Graham,Meredith Leigh %A Strawderman,Myla S %A Demment,Margaret %A Olson,Christine Marie %+ Division of Nutritional Sciences, Cornell University, Savage Hall, 4th floor, Ithaca, NY, 14853, United States, 1 585 298 5660, mlg22@cornell.edu %K Internet %K obesity %K weight gain %K pregnancy %D 2017 %7 09.01.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Excessive gestational weight gain (GWG) contributes to the development of obesity in mother and child. Internet-based interventions have the potential for delivering innovative and interactive options for prevention of excessive GWG to large numbers of people. Objective: The objective of this study was to create a novel measure of Internet-based intervention usage patterns and examine whether usage of an Internet-based intervention is associated with reduced risk of excessive GWG. Methods: The website featured blogs, local resources, articles, frequently asked questions (FAQs), and events that were available to women in both the intervention and control arm. Weekly reminders to use the website and to highlight new content were emailed to participants in both arms. Only intervention arm participants had access to the weight gain tracker and diet and physical activity goal-setting tools. A total of 1335 (898 intervention and 437 control) relatively diverse and healthy pregnant women were randomly assigned to the intervention arm or control arm. Usage patterns were examined for both intervention and control arm participants using latent class analysis. Regression analyses were used to estimate the association between usage patterns and three GWG outcomes: excessive total GWG, excessive GWG rate, and GWG. Results: Five usage patterns best characterized the usage of the intervention by intervention arm participants. Three usage patterns best characterized control arm participants’ usage. Control arm usage patterns were not associated with excessive GWG, whereas intervention arm usage patterns were associated with excessive GWG. Conclusions: The control and intervention arm usage pattern characterization is a unique methodological contribution to process evaluations for self-directed Internet-based interventions. In the intervention arm some usage patterns were associated with GWG outcomes. ClinicalTrial: ClinicalTrials.gov; Clinical Trials Number: NCT01331564; https://clinicaltrials.gov/ct2/show/NCT01331564 (Archived by WebCite at http://www.webcitation/6nI9LuX9w) %M 28069560 %R 10.2196/jmir.6644 %U http://www.jmir.org/2017/1/e6/ %U https://doi.org/10.2196/jmir.6644 %U http://www.ncbi.nlm.nih.gov/pubmed/28069560 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 1 %P e4 %T Complaint-Directed Mini-Interventions for Depressive Complaints: A Randomized Controlled Trial of Unguided Web-Based Self-Help Interventions %A Lokman,Suzanne %A Leone,Stephanie S %A Sommers-Spijkerman,Marion %A van der Poel,Agnes %A Smit,Filip %A Boon,Brigitte %+ Department of Public Mental Health, Trimbos Institute: Netherlands Institute of Mental Health and Addiction, Da Costakade 45, Utrecht, 3521 VS, Netherlands, 31 30 2959385, slokman@trimbos.nl %K prevention %K depression %K Internet-based intervention %K randomized controlled trial %D 2017 %7 04.01.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Prevention of depression is important due to the substantial burden of disease associated with it. To this end, we developed a novel, brief, and low-threshold Web-based self-help approach for depressive complaints called complaint-directed mini-interventions (CDMIs). These CDMIs focus on highly prevalent complaints that are demonstrably associated with depression and have a substantial economic impact: stress, sleep problems, and worry. Objective: The aim was to evaluate the effectiveness of the Web-based self-help CDMIs in a sample of adults with mild-to-moderate depressive symptoms compared to a wait-list control group. Methods: A two-armed randomized controlled trial was conducted. An open recruitment strategy was used. Participants were randomized to either the Web-based CDMIs or the no-intervention wait-list control group. The CDMIs are online, unguided, self-help interventions, largely based on cognitive behavioral techniques, which consist of 3 to 4 modules with up to 6 exercises per module. Participants are free to choose between the modules and exercises. Assessments, using self-report questionnaires, took place at baseline and at 3 and 6 months after baseline. The control group was given access to the intervention following the 3-month assessment. The primary goal of the CDMIs is to reduce depressive complaints. The primary outcome of the study was a reduction in depressive complaints as measured by the Inventory of Depressive Symptomatology Self-Report (IDS-SR). Secondary outcomes included reductions in stress, worry, sleep problems, and anxiety complaints, and improvements in well-being. Data were analyzed using linear mixed models. Results: In total, 329 participants enrolled in the trial, of which 165 were randomized to the intervention group and 164 to the control group. Approximately three-quarters of the intervention group actually created an account. Of these participants, 91.3% (116/127) logged into their chosen CDMI at least once during the 3-month intervention period (median 3, range 0-166). After 3 months, there was a significant reduction in depressive symptomatology for participants in the intervention group compared to participants in the wait-list control group (reduction in depression: mean –4.47, 95% CI –6.54 to –2.40; Cohen d=–0.70). Furthermore, significant effects were observed for sleep problems, worry, anxiety, and well-being, with effect sizes ranging from –0.29 to –0.40. The intervention did not significantly reduce stress. At 6-month follow-up, the improvements in the intervention group were generally sustained. Conclusions: This study shows that the online self-help CDMIs have a positive impact on various mental health outcomes. Future research should focus on which specific strategies may boost adherence, and increase the reach of the CDMIs among people with low socioeconomic status. ClinicalTrial: Netherlands Trial Register (NTR): NTR4612; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4612 (Archived by WebCite at http://www.webcitation.org/6n4PVYddM) %M 28052840 %R 10.2196/jmir.6581 %U http://www.jmir.org/2017/1/e4/ %U https://doi.org/10.2196/jmir.6581 %U http://www.ncbi.nlm.nih.gov/pubmed/28052840 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 1 %P e5 %T Preventing Depression in Adults With Subthreshold Depression: Health-Economic Evaluation Alongside a Pragmatic Randomized Controlled Trial of a Web-Based Intervention %A Buntrock,Claudia %A Berking,Matthias %A Smit,Filip %A Lehr,Dirk %A Nobis,Stephanie %A Riper,Heleen %A Cuijpers,Pim %A Ebert,David %+ Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nuremberg, Nägelsbachstr. 25a, Erlangen, 91052, Germany, 49 91318567568, buntrockclaudia@gmail.com %K prevention %K major depressive disorders %K Internet %K early intervention %K cost effectiveness %D 2017 %7 04.01.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Psychological interventions for the prevention of depression might be a cost-effective way to reduce the burden associated with depressive disorders. Objective: To evaluate the cost-effectiveness of a Web-based guided self-help intervention to prevent major depressive disorder (MDD) in people with subthreshold depression (sD). Methods: A pragmatic randomized controlled trial was conducted with follow-up at 12 months. Participants were recruited from the general population via a large statutory health insurance company and an open access website. Participants were randomized to a Web-based guided self-help intervention (ie, cognitive-behavioral therapy and problem-solving therapy assisted by supervised graduate students or health care professionals) in addition to usual care or to usual care supplemented with Web-based psycho-education (enhanced usual care). Depression-free years (DFYs) were assessed by blinded diagnostic raters using the telephone-administered Structured Clinical Interview for DSM-IV Axis Disorders at 6- and 12-month follow-up, covering the period to the previous assessment. Costs were self-assessed through a questionnaire. Costs measured from a societal and health care perspective were related to DFYs and quality-adjusted life years (QALYs). Results: In total, 406 participants were enrolled in the trial. The mean treatment duration was 5.84 (SD 4.37) weeks. On average, participants completed 4.93 of 6 sessions. Significantly more DFYs were gained in the intervention group (0.82 vs 0.70). Likewise, QALY health gains were in favor of the intervention, but only statistically significant when measured with the more sensitive SF-6D. The incremental per-participant costs were €136 (£116). Taking the health care perspective and assuming a willingness-to-pay of €20,000 (£17,000), the intervention’s likelihood of being cost-effective was 99% for gaining a DFY and 64% or 99% for gaining an EQ-5D or a SF-6D QALY. Conclusions: Our study supports guidelines recommending Web-based treatment for sD and adds that this not only restores health in people with sD, but additionally reduces the risk of developing a MDD. Offering the intervention has an acceptable likelihood of being more cost-effective than enhanced usual care and could therefore reach community members on a wider scale. Trial registration: German Clinical Trials Register: DRKS00004709; http://www.drks.de/DRKS00004709 (Archived by WebCite at http://www.webcitation.org/6kAZVUxy9) %M 28052841 %R 10.2196/jmir.6587 %U http://www.jmir.org/2017/1/e5/ %U https://doi.org/10.2196/jmir.6587 %U http://www.ncbi.nlm.nih.gov/pubmed/28052841 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 12 %P e337 %T Drivers and Barriers to Acceptance of Web-Based Aftercare of Patients in Inpatient Routine Care: A Cross-Sectional Survey %A Hennemann,Severin %A Beutel,Manfred E %A Zwerenz,Rüdiger %+ Department of Psychosomatic Medicine and Psychotherapy, University Medical Center, Gutenberg University Mainz, Untere Zahlbacher Str. 8, Mainz, 55131, Germany, 49 6131 175981, ruediger.zwerenz@unimedizin-mainz.de %K eHealth %K attitude to health %K aftercare %K rehabilitation %K survey %D 2016 %7 23.12.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based aftercare can help to stabilize treatment effects and support transition after inpatient treatment, yet uptake by patients seems limited in routine care and little is known about the mechanisms of adoption and implementation. Objective: The aim of this study was to (1) determine acceptance of Web-based aftercare and (2) explore its drivers and barriers in different subgroups of a mixed inpatient sample. Method: In a cross-sectional design, 38.3% (374/977) of the inpatients from a broad spectrum of diagnostic groups (psychosomatic, cardiologic, orthopedic, pediatric, and substance-related disorders) filled out a self-administered questionnaire prior to discharge. Drivers and barriers to patients’ acceptance of Web-based aftercare were examined based on an extension to the “unified theory of acceptance and use of technology” (UTAUT). In total, 16.7% (59/353) of the participants indicated prior use of eHealth interventions. Results: Acceptance (min 1, max 5) was low (mean 2.56, SD 1.22) and differed between diagnostic groups (Welch F4,133.10 =7.77, P<.001), with highest acceptance in adolescent patients (mean 3.46, SD 1.42). Acceptance was significantly predicted by 3 UTAUT predictors: social influence (beta=.39, P<.001), performance expectancy (beta=.31, P<.001), and effort expectancy (beta=.22, P<.001). Furthermore, stress due to permanent availability (beta=−.09, P=.01) was negatively associated with acceptance. Conclusion: This study demonstrated a limited acceptance of Web-based aftercare in inpatients. Expectations, social environment’s attitude, and negative experience with permanent availability influence eHealth acceptance. Improving implementation, therefore, means increasing eHealth experience and literacy and facilitating positive attitudes in patients and health professionals through education and reduction of misconceptions about effectiveness or usability. %M 28011445 %R 10.2196/jmir.6003 %U http://www.jmir.org/2016/12/e337/ %U https://doi.org/10.2196/jmir.6003 %U http://www.ncbi.nlm.nih.gov/pubmed/28011445 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 12 %P e317 %T IDEAS (Integrate, Design, Assess, and Share): A Framework and Toolkit of Strategies for the Development of More Effective Digital Interventions to Change Health Behavior %A Mummah,Sarah Ann %A Robinson,Thomas N %A King,Abby C %A Gardner,Christopher D %A Sutton,Stephen %+ Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, 1265 Welch Road, Stanford, CA, 94305-5411, United States, 1 650 723 7822, sm885@cam.ac.uk %K health behavior %K design thinking %K user-centered design %K behavioral theory %K behavior change techniques %K digital interventions %K mobile phones %K digital health %K telemedicine %K diet %K exercise %K weight loss %K smoking cessation %K medication adherence %K sleep %K obesity %D 2016 %7 16.12.2016 %9 Viewpoint %J J Med Internet Res %G English %X Developing effective digital interventions to change health behavior has been a challenging goal for academics and industry players alike. Guiding intervention design using the best combination of approaches available is necessary if effective technologies are to be developed. Behavioral theory, design thinking, user-centered design, rigorous evaluation, and dissemination each have widely acknowledged merits in their application to digital health interventions. This paper introduces IDEAS, a step-by-step process for integrating these approaches to guide the development and evaluation of more effective digital interventions. IDEAS is comprised of 10 phases (empathize, specify, ground, ideate, prototype, gather, build, pilot, evaluate, and share), grouped into 4 overarching stages: Integrate, Design, Assess, and Share (IDEAS). Each of these phases is described and a summary of theory-based behavioral strategies that may inform intervention design is provided. The IDEAS framework strives to provide sufficient detail without being overly prescriptive so that it may be useful and readily applied by both investigators and industry partners in the development of their own mHealth, eHealth, and other digital health behavior change interventions. %M 27986647 %R 10.2196/jmir.5927 %U http://www.jmir.org/2016/12/e317/ %U https://doi.org/10.2196/jmir.5927 %U http://www.ncbi.nlm.nih.gov/pubmed/27986647 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 12 %P e322 %T A Diabetes Self-Management Program: 12-Month Outcome Sustainability From a Nonreinforced Pragmatic Trial %A Lorig,Kate %A Ritter,Philip L %A Turner,Ralph M %A English,Kathleen %A Laurent,Diana D %A Greenberg,Jay %+ Stanford Patient Education Research Center, Medicine, Stanford University, 1000 Welch Rd, Palo Alto, CA, 94306, United States, 1 650 725 2873, philr@stanford.edu %K patient education %K self-management %K type 2 diabetes %D 2016 %7 15.12.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Diabetes self-management education has been shown to be effective in controlled trials. The 6-week Better Choices, Better Health-Diabetes (BCBH-D) self-management program was also associated with an improvement in health outcomes in a 6-month translation study. Objective: The objective of this study was to determine whether a national translation of the BCBH-D self-management program, offered both Web-based and face-to-face, was associated with improvements in health outcomes (including HbA1c) and health behaviors (including recommended medical tests) 1 year after intervention Methods: Web-based programs were administered nationally, whereas face-to-face workshops took place in Atlanta, Indianapolis, and St Louis. Self-report questionnaires were either Web-based or administered by mail, at baseline and 1 year, and collected health and health-behavior measures. HbA1c blood samples were collected via mailed kits. A previous 6-month study found statistically significant improvements in 13 of 14 outcome measures, including HbA1c. For this study, paired t test compared baseline with 1-year outcomes. Subgroup analyses determined whether participants with specific conditions improved (high HbA1c, depression, hypoglycemia, nonadherence to medication, no aerobic exercise). The percentage of participants with improvements in effect size of at least 0.4 in at least 1 of the 5 measures was calculated. Results: A total of 857 participants with 1-year data (69.7% of baseline participants) demonstrated statistically significant 1-year improvements in 13 of 15 outcome measures; 79.9% (685/857) of participants showed improvements in effect size of 0.4 or greater in at least 1 of the 5 criterial measures. Conclusions: Participants had small but significant benefits in multiple measures. Improvements previously noted at 6 months were maintained or amplified at 1 year. %M 27979790 %R 10.2196/jmir.6484 %U http://www.jmir.org/2016/12/e322/ %U https://doi.org/10.2196/jmir.6484 %U http://www.ncbi.nlm.nih.gov/pubmed/27979790 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 12 %P e321 %T An Ecological Momentary Intervention for Smoking Cessation: Evaluation of Feasibility and Effectiveness %A Businelle,Michael S %A Ma,Ping %A Kendzor,Darla E %A Frank,Summer G %A Vidrine,Damon J %A Wetter,David W %+ Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, 655 Research Parkway, Suite 400, Oklahoma City, OK, 73104, United States, 1 405 271 8001 ext 50460, michael-businelle@ouhsc.edu %K smartphone %K mobile applications %K smoking cessation %K low income population %D 2016 %7 12.12.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite substantial public health progress in reducing the prevalence of smoking in the United States overall, smoking among socioeconomically disadvantaged adults remains high. Objective: To determine the feasibility and preliminary effectiveness of a novel smartphone-based smoking cessation app designed for socioeconomically disadvantaged smokers. Methods: Participants were recruited from a safety-net hospital smoking cessation clinic in Dallas, Texas, and were followed for 13 weeks. All participants received standard smoking cessation clinic care (ie, group counseling and cessation pharmacotherapy) and a smartphone with a novel smoking cessation app (ie, Smart-T). The Smart-T app prompted 5 daily ecological momentary assessments (EMAs) for 3 weeks (ie, 1 week before cessation and 2 weeks after cessation). During the precessation period, EMAs were followed by messages that focused on planning and preparing for the quit attempt. During the postcessation period, participant responses to EMAs drove an algorithm that tailored messages to the current level of smoking lapse risk and currently present lapse triggers (eg, urge to smoke, stress). Smart-T offered additional intervention features on demand (eg, one-click access to the tobacco cessation quitline; “Quit Tips” on coping with urges to smoke, mood, and stress). Results: Participants (N=59) were 52.0 (SD 7.0) years old, 54% (32/59) female, and 53% (31/59) African American, and 70% (40/57) had annual household income less than US $16,000. Participants smoked 20.3 (SD 11.6) cigarettes per day and had been smoking for 31.6 (SD 10.9) years. Twelve weeks after the scheduled quit date, 20% (12/59) of all participants were biochemically confirmed abstinent. Participants responded to 87% of all prompted EMAs and received approximately 102 treatment messages over the 3-week EMA period. Most participants (83%, 49/59) used the on-demand app features. Individuals with greater nicotine dependence and minority race used the Quit Tips feature more than their counterparts. Greater use of the Quit Tips feature was linked to nonabstinence at the 2 (P=.02), 4 (P<.01), and 12 (P=.03) week follow-up visits. Most participants reported that they actually used or implemented the tailored app-generated messages and suggestions (83%, 49/59); the app-generated messages were helpful (97%, 57/59); they would like to use the app in the future if they were to lapse (97%, 57/59); and they would like to refer friends who smoke to use the Smart-T app (85%, 50/59). A minority of participants (15%, 9/59) reported that the number of daily assessments (ie, 5) was “too high.” Conclusions: This novel just-in-time adaptive intervention delivered an intensive intervention (ie, 102 messages over a 3-week period), was well-liked, and was perceived as helpful and useful by socioeconomically disadvantaged adults who were seeking smoking cessation treatment. Smartphone apps may be used to increase treatment exposure and may ultimately reduce tobacco-related health disparities among socioeconomically disadvantaged adults. %M 27956375 %R 10.2196/jmir.6058 %U http://www.jmir.org/2016/12/e321/ %U https://doi.org/10.2196/jmir.6058 %U http://www.ncbi.nlm.nih.gov/pubmed/27956375 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 12 %P e316 %T An eHealth Project on Invasive Pneumococcal Disease: Comprehensive Evaluation of a Promotional Campaign %A Panatto,Donatella %A Domnich,Alexander %A Gasparini,Roberto %A Bonanni,Paolo %A Icardi,Giancarlo %A Amicizia,Daniela %A Arata,Lucia %A Carozzo,Stefano %A Signori,Alessio %A Bechini,Angela %A Boccalini,Sara %+ Department of Health Sciences, University of Genoa, Via Pastore, 1, Genoa, 16132, Italy, 39 0103538109, panatto@unige.it %K invasive pneumococcal disease %K pneumococcus %K eHealth %K mHealth %K mobile app %D 2016 %7 02.12.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: The recently launched Pneumo Rischio eHealth project, which consists of an app, a website, and social networking activity, is aimed at increasing public awareness of invasive pneumococcal disease (IPD). The launch of this project was prompted by the inadequate awareness of IPD among both laypeople and health care workers, the heavy socioeconomic burden of IPD, and the far from optimal vaccination coverage in Italy, despite the availability of safe and effective vaccines. Objective: The objectives of our study were to analyze trends in Pneumo Rischio usage before and after a promotional campaign, to characterize its end users, and to assess its user-rated quality. Methods: At 7 months after launching Pneumo Rischio, we established a 4-month marketing campaign to promote the project. This intervention used various approaches and channels, including both traditional and digital marketing strategies. To highlight usage trends, we used different techniques of time series analysis and modeling, including a modified Mann-Kendall test, change-point detection, and segmented negative binomial regression of interrupted time series. Users were characterized in terms of demographics and IPD risk categories. Customer-rated quality was evaluated by means of a standardized tool in a sample of app users. Results: Over 1 year, the app was accessed by 9295 users and the website was accessed by 143,993 users, while the project’s Facebook page had 1216 fans. The promotional intervention was highly effective in increasing the daily number of users. In particular, the Mann-Kendall trend test revealed a significant (P ≤.01) increasing trend in both app and website users, while change-point detection analysis showed that the first significant change corresponded to the start of the promotional campaign. Regression analysis showed a significant immediate effect of the intervention, with a mean increase in daily numbers of users of 1562% (95% CI 456%-4870%) for the app and 620% (95% CI 176%-1777%) for the website. Similarly, the postintervention daily trend in the number of users was positive, with a relative increase of 0.9% (95% CI 0.0%-1.8%) for the app and 1.4% (95% CI 0.7%-2.1%) for the website. Demographics differed between app and website users and Facebook fans. A total of 69.15% (10,793/15,608) of users could be defined as being at risk of IPD, while 4729 users expressed intentions to ask their doctor for further information on IPD. The mean app quality score assigned by end users was approximately 79.5% (397/500). Conclusions: Despite its specific topic, Pneumo Rischio was accessed by a considerable number of users, who ranked it as a high-quality project. In order to reach their target populations, however, such projects should be promoted. %M 27913372 %R 10.2196/jmir.6205 %U http://www.jmir.org/2016/12/e316/ %U https://doi.org/10.2196/jmir.6205 %U http://www.ncbi.nlm.nih.gov/pubmed/27913372 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 12 %P e313 %T The Effectiveness of Web-Based Asthma Self-Management System, My Asthma Portal (MAP): A Pilot Randomized Controlled Trial %A Ahmed,Sara %A Ernst,Pierre %A Bartlett,Susan J %A Valois,Marie-France %A Zaihra,Tasneem %A Paré,Guy %A Grad,Roland %A Eilayyan,Owis %A Perreault,Robert %A Tamblyn,Robyn %+ McGill University Health Center, Division of Clinical Epidemiology, McGill University, 3654 Prom Sir-William-Osler, Montreal, QC, H3G 1Y5, Canada, 1 514 398 4400 ext 00531, sara.ahmed@mcgill.ca %K Internet %K nursing %K case management %K self-care %K asthma %K quality of life %D 2016 %7 01.12.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Whether Web-based technologies can improve disease self-management is uncertain. My Asthma Portal (MAP) is a Web-based self-management support system that couples evidence-based behavioral change components (self-monitoring of symptoms, physical activity, and medication adherence) with real-time monitoring, feedback, and support from a nurse case manager. Objective: The aim of this study was to compare the impact of access to a Web-based asthma self-management patient portal linked to a case-management system (MAP) over 6 months compared with usual care on asthma control and quality of life. Methods: A multicenter, parallel, 2-arm, pilot, randomized controlled trial was conducted with 100 adults with confirmed diagnosis of asthma from 2 specialty clinics. Asthma control was measured using an algorithm based on overuse of fast-acting bronchodilators and emergency department visits, and asthma-related quality of life was assessed using the Mini-Asthma Quality of Life Questionnaire (MAQLQ). Secondary mediating outcomes included asthma symptoms, depressive symptoms, self-efficacy, and beliefs about medication. Process evaluations were also included. Results: A total of 49 individuals were randomized to MAP and 51 to usual care. Compared with usual care, participants in the intervention group reported significantly higher asthma quality of life (mean change 0.61, 95% CI 0.03 to 1.19), and the change in asthma quality of life for the intervention group between baseline and 3 months (mean change 0.66, 95% CI 0.35 to 0.98) was not seen in the control group. No significant differences in asthma quality of life were found between the intervention and control groups at 6 (mean change 0.46, 95% CI –0.12 to 1.05) and 9 months (mean change 0.39, 95% CI –0.2 to 0.98). For poor control status, there was no significant effect of group, time, or group by time. For all self-reported measures, the intervention group had a significantly higher proportion of individuals, demonstrating a minimal clinically meaningful improvement compared with the usual care group. Conclusions: This study supported the use of MAP to enhance asthma quality of life but not asthma control as measured by an administrative database. Implementation of MAP beyond 6 months with tailored protocols for monitoring symptoms and health behaviors as individuals’ knowledge and self-management skills improve may result in long-term gains in asthma control. ClinicalTrial: International Standard Randomized Controlled Trial Number (ISRCTN): 34326236; http://www.isrctn.com/ISRCTN34326236 (Archived by Webcite at http://www.webcitation.org/6mGxoI1R7). %M 27908846 %R 10.2196/jmir.5866 %U http://www.jmir.org/2016/12/e313/ %U https://doi.org/10.2196/jmir.5866 %U http://www.ncbi.nlm.nih.gov/pubmed/27908846 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 11 %P e310 %T Impact of Information Technology–Based Interventions for Type 2 Diabetes Mellitus on Glycemic Control: A Systematic Review and Meta-Analysis %A Alharbi,Nouf Sahal %A Alsubki,Nada %A Jones,Simon %A Khunti,Kamlesh %A Munro,Neil %A de Lusignan,Simon %+ University of Surrey, Stag Hill, Guildford, GU2 7XH, United Kingdom, 44 483 68 3089, s.lusignan@surrey.ac.uk %K diabetes mellitus %K medical informatics applications %K technology %D 2016 %7 25.11.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Information technology–based interventions are increasingly being used to manage health care. However, there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes. Objective: The objective of this study was to conduct a systematic review and meta-analysis of clinical trials, assessing the impact of information technology on changes in the levels of hemoglobin A1c (HbA1c) and mapping the interventions with chronic care model (CCM) elements. Methods: Electronic databases PubMed and EMBASE were searched to identify relevant studies that were published up until July 2016, a method that was supplemented by identifying articles from the references of the articles already selected using the electronic search tools. The study search and selection were performed by independent reviewers. Of the 1082 articles retrieved, 32 trials (focusing on a total of 40,454 patients) were included. A random-effects model was applied to estimate the pooled results. Results: Information technology–based interventions were associated with a statistically significant reduction in HbA1c levels (mean difference −0.33%, 95% CI −0.40 to −0.26, P<.001). Studies focusing on electronic self-management systems demonstrated the largest reduction in HbA1c (0.50%), followed by those with electronic medical records (0.17%), an electronic decision support system (0.15%), and a diabetes registry (0.05%). In addition, the more CCM-incorporated the information technology–based interventions were, the more improvements there were in HbA1c levels. Conclusions: Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes. No clinically relevant impact was observed on low-density lipoprotein levels and blood pressure, but there was evidence that the cost of care was lower. %M 27888169 %R 10.2196/jmir.5778 %U http://www.jmir.org/2016/11/e310/ %U https://doi.org/10.2196/jmir.5778 %U http://www.ncbi.nlm.nih.gov/pubmed/27888169 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 11 %P e305 %T Clinical Relevance of the First Domomedicine Platform Securing Multidrug Chronotherapy Delivery in Metastatic Cancer Patients at Home: The inCASA European Project %A Innominato,Pasquale F %A Komarzynski,Sandra %A Mohammad-Djafari,Ali %A Arbaud,Alexandre %A Ulusakarya,Ayhan %A Bouchahda,Mohamed %A Haydar,Mazen %A Bossevot-Desmaris,Rachel %A Plessis,Virginie %A Mocquery,Magali %A Bouchoucha,Davina %A Afshar,Mehran %A Beau,Jacques %A Karaboué,Abdoulaye %A Morère,Jean-François %A Fursse,Joanna %A Rovira Simon,Jordi %A Levi,Francis %+ Cancer Chronotherapy Unit, Cancer Research Centre, Warwick Medical School, Gibbet Hill Road, Coventry, CV4 7AL, United Kingdom, 44 2476575132, F.Levi@warwick.ac.uk %K domomedicine %K chronotherapy %K actigraphy %K MDASI %K telemonitoring %D 2016 %7 25.11.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Telehealth solutions can improve the safety of ambulatory chemotherapy, contributing to the maintenance of patients at their home, hence improving their well-being, all the while reducing health care costs. There is, however, need for a practicable multilevel monitoring solution, encompassing relevant outputs involved in the pathophysiology of chemotherapy-induced toxicity. Domomedicine embraces the delivery of complex care and medical procedures at the patient’s home based on modern technologies, and thus it offers an integrated approach for increasing the safety of cancer patients on chemotherapy. Objective: The objective was to evaluate patient compliance and clinical relevance of a novel integrated multiparametric telemonitoring domomedicine platform in cancer patients receiving multidrug chemotherapy at home. Methods: Self-measured body weight, self-rated symptoms using the 19-item MD Anderson Symptom Inventory (MDASI), and circadian rest-activity rhythm recording with a wrist accelerometer (actigraph) were transmitted daily by patients to a server via the Internet, using a dedicated platform installed at home. Daily body weight changes, individual MDASI scores, and relative percentage of activity in-bed versus out-of-bed (I0.8) overall. There was no significant difference between groups in the amount of improvement from baseline to the average of the follow-ups. We found that participants who stopped drinking before joining the clinical trial had significantly better outcomes than participants who were still drinking when they joined the study. Neither Internet fluency nor participants’ reported ease of navigating the site had an impact on outcomes. Conclusions: These results support our first experimental hypothesis but not the second. On average, participants improved on all dependent measures. Both SR and OA helped participants recover from their problem drinking. Web-based interventions can help even those individuals with lengthy histories of heavy drinking to make clinically significant reductions in their consumption and related problems. These interventions work well for individuals in the action stage of change. Trial Registration: Clinicaltrials.gov NCT01389297; https://clinicaltrials.gov/ct2/show/NCT01389297 (Archived by WebCite at http://www.webcitation.org/6kLNUNDcc) %M 27701064 %R 10.2196/jmir.5508 %U http://www.jmir.org/2016/10/e262/ %U https://doi.org/10.2196/jmir.5508 %U http://www.ncbi.nlm.nih.gov/pubmed/27701064 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 3 %N 3 %P e47 %T Web-Based Intervention to Reduce Substance Abuse and Depressive Symptoms in Mexico: Development and Usability Test %A Tiburcio,Marcela %A Lara,Ma Asunción %A Aguilar Abrego,Araceli %A Fernández,Morise %A Martínez Vélez,Nora %A Sánchez,Alejandro %+ Ramón de la Fuente Muñiz, National Institute of Psychiatry, Department of Social Sciences in Health, Direction of Epidemiological and Psychosocial Research, Calz Mexico-Xochimilco 101, Col San Lorenzo Huipulco, Del Tlalpan, Mexico City, 14370, Mexico, 52 5541605162, tibsam@imp.edu.mx %K substance abuse %K depressive symptoms %K Internet %K cognitive behavioral therapy %K usability %D 2016 %7 29.09.2016 %9 Original Paper %J JMIR Ment Health %G English %X Background: The development of Web-based interventions for substance abuse in Latin America is a new field of interest with great potential for expansion to other Spanish-speaking countries. Objective: This paper describes a project aimed to develop and evaluate the usability of the Web-based Help Program for Drug Abuse and Depression (Programa de Ayuda para Abuso de Drogas y Depresión, PAADD, in Spanish) and also to construct a systematic frame of reference for the development of future Web-based programs. Methods: The PAADD aims to reduce substance use and depressive symptoms with cognitive behavioral techniques translated into Web applications, aided by the participation of a counselor to provide support and guidance. This Web-based intervention includes 4 steps: (1) My Starting Point, (2) Where Do I Want to Be? (3) Strategies for Change, and (4) Maintaining Change. The development of the program was an interactive multistage process. The first stage defined the core structure and contents, which were validated in stage 2 by a group of 8 experts in addiction treatment. Programming of the applications took place in stage 3, taking into account 3 types of end users: administrators, counselors, and substance users. Stage 4 consisted of functionality testing. In stage 5, a total of 9 health professionals and 20 drug users currently in treatment voluntarily interacted with the program in a usability test, providing feedback about adjustments needed to improve users’ experience. Results: The main finding of stage 2 was the consensus of the health professionals about the cognitive behavioral strategies and techniques included in PAADD being appropriate for changing substance use behaviors. In stage 5, the health professionals found the functionalities easy to learn; their suggestions were related to the page layout, inclusion of confirmation messages at the end of activities, avoiding “read more” links, and providing feedback about every activity. On the other hand, the users said the information presented within the modules was easy to follow and suggested more dynamic features with concrete instructions and feedback. Conclusions: The resulting Web-based program may have advantages over traditional face-to-face therapies owing to its low cost, wide accessibility, anonymity, and independence of time and distance factors. The detailed description of the process of designing a Web-based program is an important contribution to others interested in this field. The potential benefits must be verified in specific studies. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 25429892; http://www.controlled-trials.com/ISRCTN25429892 (Archived by WebCite at http://www.webcitation.org/6ko1Fsvym) %M 27687965 %R 10.2196/mental.6001 %U http://mental.jmir.org/2016/3/e47/ %U https://doi.org/10.2196/mental.6001 %U http://www.ncbi.nlm.nih.gov/pubmed/27687965 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 9 %P e257 %T Design and Testing of BACRA, a Web-Based Tool for Middle Managers at Health Care Facilities to Lead the Search for Solutions to Patient Safety Incidents %A Carrillo,Irene %A Mira,José Joaquín %A Vicente,Maria Asuncion %A Fernandez,Cesar %A Guilabert,Mercedes %A Ferrús,Lena %A Zavala,Elena %A Silvestre,Carmen %A Pérez-Pérez,Pastora %+ Health Psychology Department, Miguel Hernández University, Universidad s/n, Elche, 03202, Spain, 34 966658984, icarrillo@umh.es %K patient safety %K risk management %K root cause analysis %K hospital %K primary care %K frontline health professionals %K middle managers %D 2016 %7 27.09.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Lack of time, lack of familiarity with root cause analysis, or suspicion that the reporting may result in negative consequences hinder involvement in the analysis of safety incidents and the search for preventive actions that can improve patient safety. Objective: The aim was develop a tool that enables hospitals and primary care professionals to immediately analyze the causes of incidents and to propose and implement measures intended to prevent their recurrence. Methods: The design of the Web-based tool (BACRA) considered research on the barriers for reporting, review of incident analysis tools, and the experience of eight managers from the field of patient safety. BACRA’s design was improved in successive versions (BACRA v1.1 and BACRA v1.2) based on feedback from 86 middle managers. BACRA v1.1 was used by 13 frontline professionals to analyze incidents of safety; 59 professionals used BACRA v1.2 and assessed the respective usefulness and ease of use of both versions. Results: BACRA contains seven tabs that guide the user through the process of analyzing a safety incident and proposing preventive actions for similar future incidents. BACRA does not identify the person completing each analysis since the password introduced to hide said analysis only is linked to the information concerning the incident and not to any personal data. The tool was used by 72 professionals from hospitals and primary care centers. BACRA v1.2 was assessed more favorably than BACRA v1.1, both in terms of its usefulness (z=2.2, P=.03) and its ease of use (z=3.0, P=.003). Conclusions: BACRA helps to analyze incidents of safety and to propose preventive actions. BACRA guarantees anonymity of the analysis and reduces the reluctance of professionals to carry out this task. BACRA is useful and easy to use. %M 27678308 %R 10.2196/jmir.5942 %U http://www.jmir.org/2016/9/e257/ %U https://doi.org/10.2196/jmir.5942 %U http://www.ncbi.nlm.nih.gov/pubmed/27678308 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 9 %P e255 %T Post-9/11 Veterans and Their Partners Improve Mental Health Outcomes with a Self-directed Mobile and Web-based Wellness Training Program: A Randomized Controlled Trial %A Kahn,Janet R %A Collinge,William %A Soltysik,Robert %+ College of Medicine, Department of Psychiatry, University of Vermont, 240 Maple Street, Burlington, VT, 05401, United States, 1 802 578 2990, Janet.Kahn@uvm.edu %K veterans %K PTSD %K moral injury %K mind-body therapies %K mindfulness %K patient-centered care %K compassion %K Web-based program %K reintegration %D 2016 %7 27.09.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Veterans with history of deployment in the Global War on Terror face significant and ongoing challenges with high prevalences of adverse psychological, physical, spiritual, and family impacts. Together, these challenges contribute to an emerging public health crisis likely to extend well into the future. Innovative approaches are needed that reach veterans and their family members with strategies they can employ over time in their daily lives to promote improved adjustment and well-being. Objective: The objective of this study was to evaluate effects of use of a Web-based, self-directed program of instruction in mind- and body-based wellness skills to be employed by Global War on Terror veterans and their significant relationship partners on mental health and wellness outcomes associated with postdeployment readjustment. Methods: We recruited 160 veteran-partner dyads in 4 regions of the United States (San Diego, CA; Dallas, TX; Fayetteville, NC; and New York, NY) through publicity by the Iraq and Afghanistan Veterans of America to its membership. Dyads were randomly allocated to 1 of 4 study arms: Mission Reconnect (MR) program alone, MR plus the Prevention and Relationship Enhancement Program (PREP) for Strong Bonds weekend program for military couples, PREP alone, and waitlist control. We administered a battery of standardized and investigator-generated instruments assessing mental health outcomes at baseline, 8 weeks, and 16 weeks. Dyads in the MR arms were provided Web-based and mobile app video and audio instruction in a set of mindfulness-related stress reduction and contemplative practices, as well as partner massage for reciprocal use. All participants provided weekly reports on frequency and duration of self-care practices for the first 8 weeks, and at 16 weeks. Results: During the first 8-week reporting period, veterans and partners assigned to MR arms used some aspect of the program a mean of 20 times per week, totaling nearly 2.5 hours per week, with only modest declines in use at 16 weeks. Significant improvements were seen at 8 and 16 weeks in measures of posttraumatic stress disorder, depression, sleep quality, perceived stress, resilience, self-compassion, and pain for participants assigned to MR arms. In addition, significant reductions in self-reported levels of pain, tension, irritability, anxiety, and depression were associated with use of partner massage. Conclusions: Both veterans and partners were able to learn and make sustained use of a range of wellness practices taught in the MR program. Home-based, self-directed interventions may be of particular service to veterans who are distant from, averse to, or prohibited by schedule from using professional services. Leveraging the partner relationship may enhance sustained use of self-directed interventions for this population. Use of the MR program appears to be an accessible, low-cost approach that supports well-being and reduces multiple symptoms among post-9/11 veterans and their partners. Trial Registration: Clinicaltrials.gov NCT01680419; https://clinicaltrials.gov/ct2/show/NCT01680419 (Archived by WebCite at http://www.webcitation.org/6jJuadfzj) %M 27678169 %R 10.2196/jmir.5800 %U http://www.jmir.org/2016/9/e255/ %U https://doi.org/10.2196/jmir.5800 %U http://www.ncbi.nlm.nih.gov/pubmed/27678169 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 3 %N 3 %P e45 %T Can We Foster a Culture of Peer Support and Promote Mental Health in Adolescence Using a Web-Based App? A Control Group Study %A Bohleber,Laura %A Crameri,Aureliano %A Eich-Stierli,Brigitte %A Telesko,Rainer %A von Wyl,Agnes %+ School of Applied Psychology, Zurich University of Applied Sciences, Pfingstweidstrasse 96, POB 707, Zurich,, Switzerland, 41 58 934 84 36, bohb@zhaw.ch %K mental health %K health promotion %K mobile applications %K adolescence %K peer group %K mentors %D 2016 %7 23.09.2016 %9 Original Paper %J JMIR Ment Health %G English %X Background: Adolescence with its many transitions is a vulnerable period for the development of mental illnesses. Establishing effective mental health promotion programs for this age group is a challenge crucial to societal health. Programs must account for the specific developmental tasks that adolescents face. Considering peer influence and fostering adolescent autonomy strivings is essential. Participation in a program should be compelling to young people, and their affinity to new technologies offers unprecedented opportunities in this respect. Objective: The Companion App was developed as a Web-based app giving adolescents access to a peer mentoring system and interactive, health-relevant content to foster a positive peer culture among adolescents and thereby strengthen social support and reduce stress. Methods: In a control group study design, a group of employed (n=546) and unemployed (n=73) adolescents had access to the Companion App during a 10-month period. The intervention was evaluated using a combination of quantitative and qualitative approaches. Linear mixed effects models were used to analyze changes in chronic stress levels and perception of social support. Monthly feedback on the app and qualitative interviews at the end of the study allowed for an in-depth exploration of the adolescents’ perception of the intervention. Results: Adolescents in the intervention group did not use the Companion App consistently. The intervention had no significant effect on chronic stress levels or the perception of social support. Adolescents reported endorsing the concept of the app and the implementation of a peer mentoring system in particular. However, technical difficulties and insufficiently obvious benefits of using the app impeded more frequent usage. Conclusions: The Companion Project implemented a theory-driven and innovative approach to mental health promotion in adolescence, taking into account the specifics of this developmental phase. Particularities of the implementation context, technical aspects of the app, and insufficient incentives may have played considerable roles concerning the difficulties of the Companion Project to establish commitment. However, adopting peer mentoring as a strategy and using an app still seems to us a promising approach in mental health promotion in adolescents. Future projects should be careful to invest enough resources into the technical development of an app and consider a large use of incentives to establish commitment. When targeting risk groups, such as unemployed adolescents, it may be expedient to use more structured approaches including face-to-face support. %M 27663691 %R 10.2196/mental.5597 %U http://mental.jmir.org/2016/3/e45/ %U https://doi.org/10.2196/mental.5597 %U http://www.ncbi.nlm.nih.gov/pubmed/27663691 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 9 %P e243 %T Program Use and Outcome Change in a Web-Based Trauma Intervention: Individual and Social Factors %A Wang,Zhiyun %A Wang,Jianping %A Maercker,Andreas %+ School of Psychology, Beijing Normal University, No. 19, XinJieKouWai St., HaiDian District, Beijing, 100875, China, 86 10 5880 9004, wjphh@bnu.edu.cn %K Web-based intervention %K program use %K trauma %K adherence %K social support %D 2016 %7 09.09.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Insight into user adherence to Web-based intervention programs and into its relationship to intervention effect is needed. Objective: The objective of this study was to examine use of a Web-based self-help intervention program, the Chinese version of My Trauma Recovery (CMTR), among Chinese traumatized individuals, and to investigate the relationship between program use and user characteristics before the intervention and change in outcomes after the intervention and at 3-months’ follow-up. Methods: The sample consisted of 56 urban survivors of different trauma types and 90 rural survivors of the 2008 Sichuan earthquake, who used the CMTR in 1 month on their own or guided by volunteers in a counseling center. Predictors were demographics (sex, age, highest education, marital status, and annual family income), health problems (trauma duration, posttraumatic symptoms, and depression), psychological factors (coping self-efficacy), and social factors (social functioning impairment and social support). Program use was assessed by general program usage (eg, number of visiting days) and program adherence (eg, webpages completed in modules). Outcome measures were the Posttraumatic Diagnostic Scale (PDS), Symptom Checklist 90-Depression (SCL-D), Trauma Coping Self-Efficacy scale (CSE), Crisis Support Scale (CSS), and Social Functioning Impairment questionnaire (SFI) adopted from the CMTR. Results: (1) Program use: rural participants had a larger total number of visiting days (F1,144=40.50, P<.001) and visited more program modules in 1 month (χ23=73.67, P<.001) than urban participants. (2) Predictors and program use: total number of visiting days was correlated with CSS at pretest (r=.22, P=.009), and total number of completed webpages was associated with SFI at pretest (r=.19, P=.02). Number of webpages completed in modules was correlated with all demographic, disease severity, psychological, and social factors at pretest. (3) Program use and outcomes change: in general, use of the triggers and self-talk modules showed a consistent positive association with improvement in PDS, SCL-D, SFI, and CSE. The relaxation module was associated with positive change in PDS, but with negative change in CSS and SFI. The professional help module was associated with positive change in SCL-D, but its use on the first day was associated with negative change in CSS and CSE. The unhelpful coping module was associated with negative change in SFI. The mastery tools module showed a consistent association with negative change in PDS and SCL-D. Conclusions: These findings suggest that both individual (eg, demographic, health problems, psychological) and social factors (eg, social functioning, social support) should be considered when delivering Web-based interventions, particularly in collectivist cultures. Specific program adherence indicators (eg, webpages completed in each module, activity types completed), rather than general program usage indicators (eg, total number or time of visiting), should be developed to examine the effectiveness of various program modules or elements. Clinical Trial: Australian New Zealand Clinical Trials Registry: ACTRN12611000951954; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=343399 (Archived by WebCite at http://www.webcitation.org/6G7WyNODk) %M 27612932 %R 10.2196/jmir.5839 %U http://www.jmir.org/2016/9/e243/ %U https://doi.org/10.2196/jmir.5839 %U http://www.ncbi.nlm.nih.gov/pubmed/27612932 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 8 %P e231 %T An Internet-Based Intervention for Depression in Primary Care in Spain: A Randomized Controlled Trial %A Montero-Marín,Jesús %A Araya,Ricardo %A Pérez-Yus,María C %A Mayoral,Fermín %A Gili,Margalida %A Botella,Cristina %A Baños,Rosa %A Castro,Adoración %A Romero-Sanchiz,Pablo %A López-Del-Hoyo,Yolanda %A Nogueira-Arjona,Raquel %A Vives,Margarita %A Riera,Antoni %A García-Campayo,Javier %+ Aragon Health Sciences Institute, Avda. San Juan Bosco, 13. 50009. Zaragoza., Zaragoza,, Spain, 34 (+34) 976715895, mcperezy@gmail.com %D 2016 %7 26.08.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression is the most prevalent cause of illness-induced disability worldwide. Face-to-face psychotherapeutic interventions for depression can be challenging, so there is a need for other alternatives that allow these interventions to be offered. One feasible alternative is Internet-based psychological interventions. This is the first randomized controlled trial (RCT) on the effectiveness of an Internet-based intervention on depression in primary health care in Spain. Objective: Our aim was to compare the effectiveness of a low-intensity therapist-guided (LITG) Internet-based program and a completely self-guided (CSG) Internet-based program with improved treatment as usual (iTAU) care for depression. Methods: Multicenter, three-arm, parallel, RCT design, carried out between November 2012 and January 2014, with a follow-up of 15 months. In total, 296 adults from primary care settings in four Spanish regions, with mild or moderate major depression, were randomized to LITG (n=96), CSG (n=98), or iTAU (n=102). Research completers at follow-up were 63.5%. The intervention was Smiling is Fun, an Internet program based on cognitive behavioral therapy. All patients received iTAU by their general practitioners. Moreover, LITG received Smiling is Fun and the possibility of psychotherapeutic support on request by email, whereas CSG received only Smiling is Fun. The main outcome was the Beck Depression Inventory-II at 3 months from baseline. Mixed-effects multilevel analysis for repeated measures were undertaken. Results: There was no benefit for either CSG [(B coefficient=-1.15; P=.444)] or LITG [(B=-0.71; P=.634)] compared to iTAU, at 3 months. There were differences at 6 months [iTAU vs CSG (B=-4.22; P=.007); iTAU vs LITG (B=-4.34; P=.005)] and 15 months [iTAU vs CSG (B=-5.10; P=.001); iTAU vs LITG (B=-4.62; P=.002)]. There were no differences between CSG and LITG at any time. Adjusted and intention-to-treat models confirmed these findings. Conclusions: An Internet-based intervention for depression combined with iTAU conferred a benefit over iTAU alone in the Spanish primary health care system. Trial Registration: Clinicaltrials.gov NCT01611818; https://register.clinicaltrials.gov/prs/app/action/SelectProtocol? selectaction=Edit&uid=U0001NPQ&ts=2&cx=gctdh2&sid=S0003KJ6 (Archived by WebCite at http://www.webcitation.org/6jbsUvUDz) %M 27565118 %R 10.2196/jmir.5695 %U http://www.jmir.org/2016/8/e231/ %U https://doi.org/10.2196/jmir.5695 %U http://www.ncbi.nlm.nih.gov/pubmed/27565118 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 8 %P e221 %T Effectiveness of Web-Delivered Acceptance and Commitment Therapy in Relation to Mental Health and Well-Being: A Systematic Review and Meta-Analysis %A Brown,Menna %A Glendenning,Alexander %A Hoon,Alice E %A John,Ann %+ Swansea University, Medical School, ILS2, Swansea, SA2 8PP, United Kingdom, 44 179260 ext 6213, menna.brown@swansea.ac.uk %K acceptance and commitment therapy %K systematic review %K meta-analysis %K depression %K anxiety %K quality of life %K Internet-based %K mobile-based %D 2016 %7 24.08.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: The need for effective interventions to improve mental health and emotional well-being at a population level are gaining prominence both in the United Kingdom and globally. Advances in technology and widespread adoption of Internet capable devices have facilitated rapid development of Web-delivered psychological therapies. Interventions designed to manage a range of affective disorders by applying diverse therapeutic approaches are widely available. Objective: The main aim of this review was to evaluate the evidence base of acceptance and commitment therapy (ACT) in a Web-based delivery format. Method: A systematic review of the literature and meta-analysis was conducted. Two electronic databases were searched for Web-delivered interventions utilizing ACT for the management of affective disorders or well-being. Only Randomized Controlled Trials (RCTs) were included. Results: The search strategy identified 59 articles. Of these, 10 articles met the inclusion criteria specified. The range of conditions and outcome measures that were identified limited the ability to draw firm conclusions about the efficacy of Web-delivered ACT-based intervention for anxiety or well-being. Conclusions: ACT in a Web-based delivery format was found to be effective in the management of depression. Rates of adherence to study protocols and completion were high overall suggesting that this therapeutic approach is highly acceptable for patients and the general public. %M 27558740 %R 10.2196/jmir.6200 %U http://www.jmir.org/2016/8/e221/ %U https://doi.org/10.2196/jmir.6200 %U http://www.ncbi.nlm.nih.gov/pubmed/27558740 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 8 %P e229 %T Use and Appreciation of a Tailored Self-Management eHealth Intervention for Early Cancer Survivors: Process Evaluation of a Randomized Controlled Trial %A Kanera,Iris Maria %A Willems,Roy A %A Bolman,Catherine A W %A Mesters,Ilse %A Zambon,Victor %A Gijsen,Brigitte CM %A Lechner,Lilian %+ Faculty of Psychology and Educational Sciences, Open University of the Netherlands, Valkenburgerweg 177, Heerlen, 6401 DL, Netherlands, 31 455762448, iris.kanera@ou.nl %K eHealth %K web-based intervention %K computer tailoring %K cancer survivorship %K intervention usage %K appreciation %K multiple behavior intervention %K process evaluation %K self-management %D 2016 %7 23.08.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: A fully automated computer-tailored Web-based self-management intervention, Kanker Nazorg Wijzer (KNW [Cancer Aftercare Guide]), was developed to support early cancer survivors to adequately cope with psychosocial complaints and to promote a healthy lifestyle. The KNW self-management training modules target the following topics: return to work, fatigue, anxiety and depression, relationships, physical activity, diet, and smoking cessation. Participants were guided to relevant modules by personalized module referral advice that was based on participants’ current complaints and identified needs. Objective: The aim of this study was to evaluate the adherence to the module referral advice, examine the KNW module use and its predictors, and describe the appreciation of the KNW and its predictors. Additionally, we explored predictors of personal relevance. Methods: This process evaluation was conducted as part of a randomized controlled trial. Early cancer survivors with various types of cancer were recruited from 21 Dutch hospitals. Data from online self-report questionnaires and logging data were analyzed from participants allocated to the intervention condition. Chi-square tests were applied to assess the adherence to the module referral advice, negative binominal regression analysis was used to identify predictors of module use, multiple linear regression analysis was applied to identify predictors of the appreciation, and ordered logistic regression analysis was conducted to explore possible predictors of perceived personal relevance. Results: From the respondents (N=231; mean age 55.6, SD 11.5; 79.2% female [183/231]), 98.3% (227/231) were referred to one or more KNW modules (mean 2.9, SD 1.5), and 85.7% (198/231) of participants visited at least one module (mean 2.1, SD 1.6). Significant positive associations were found between the referral to specific modules (range 1-7) and the use of corresponding modules. The likelihoods of visiting modules were higher when respondents were referred to those modules by the module referral advice. Predictors of visiting a higher number of modules were a higher number of referrals by the module referral advice (β=.136, P=.009), and having a partner was significantly related with a lower number of modules used (β=-.256, P=.044). Overall appreciation was high (mean 7.5, SD 1.2; scale 1-10) and was significantly predicted by a higher perceived personal relevance (β=.623, P=.000). None of the demographic and cancer-related characteristics significantly predicted the perceived personal relevance. Conclusions: The KNW in general and more specifically the KNW modules were well used and highly appreciated by early cancer survivors. Indications were found that the module referral advice might be a meaningful intervention component to guide the users in following a preferred selection of modules. These results indicate that the fully automated Web-based KNW provides personal relevant and valuable information and support for early cancer survivors. Therefore, this intervention can complement usual cancer aftercare and may serve as a first step in a stepped-care approach. Trial Registration: Nederlands Trial Register: NTR3375; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3375 (Archived by WebCite at http://www.webcitation.org/6jo4jO7kb) %M 27554525 %R 10.2196/jmir.5975 %U http://www.jmir.org/2016/8/e229/ %U https://doi.org/10.2196/jmir.5975 %U http://www.ncbi.nlm.nih.gov/pubmed/27554525 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 8 %P e226 %T Effectiveness of mHealth Interventions Targeting Health Care Workers to Improve Pregnancy Outcomes in Low- and Middle-Income Countries: A Systematic Review %A Amoakoh-Coleman,Mary %A Borgstein,Alexander Berend-Jan %A Sondaal,Stephanie FV %A Grobbee,Diederick E %A Miltenburg,Andrea Solnes %A Verwijs,Mirjam %A Ansah,Evelyn K %A Browne,Joyce L %A Klipstein-Grobusch,Kerstin %+ Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht University, Utrecht, Netherlands, P.O. Box 85500, Utrecht, 3508 GA, Netherlands, 31 244 623553, menba19@yahoo.com %K maternal %K mHealth %K neonatal %K providers of care %K low- and middle-income countries %D 2016 %7 19.08.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Low- and middle-income countries (LMICs) face the highest burden of maternal and neonatal deaths. Concurrently, they have the lowest number of physicians. Innovative methods such as the exchange of health-related information using mobile devices (mHealth) may support health care workers in the provision of antenatal, delivery, and postnatal care to improve maternal and neonatal outcomes in LMICs. Objective: We conducted a systematic review evaluating the effectiveness of mHealth interventions targeting health care workers to improve maternal and neonatal outcomes in LMIC. Methods: The Cochrane Library, PubMed, EMBASE, Global Health Library, and Popline were searched using predetermined search and indexing terms. Quality assessment was performed using an adapted Cochrane Risk of Bias Tool. A strength, weakness, opportunity, and threat analysis was performed for each included paper. Results: A total of 19 studies were included for this systematic review, 10 intervention and 9 descriptive studies. mHealth interventions were used as communication, data collection, or educational tool by health care providers primarily at the community level in the provision of antenatal, delivery, and postnatal care. Interventions were used to track pregnant women to improve antenatal and delivery care, as well as facilitate referrals. None of the studies directly assessed the effect of mHealth on maternal and neonatal mortality. Challenges of mHealth interventions to assist health care workers consisted mainly of technical problems, such as mobile network coverage, internet access, electricity access, and maintenance of mobile phones. Conclusions: mHealth interventions targeting health care workers have the potential to improve maternal and neonatal health services in LMICs. However, there is a gap in the knowledge whether mHealth interventions directly affect maternal and neonatal outcomes and future research should employ experimental designs with relevant outcome measures to address this gap. %M 27543152 %R 10.2196/jmir.5533 %U http://www.jmir.org/2016/8/e226/ %U https://doi.org/10.2196/jmir.5533 %U http://www.ncbi.nlm.nih.gov/pubmed/27543152 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 3 %N 3 %P e38 %T Effectiveness of Internet-Based Interventions for the Prevention of Mental Disorders: A Systematic Review and Meta-Analysis %A Sander,Lasse %A Rausch,Leonie %A Baumeister,Harald %+ Institute of Psychology, Depatment of Rehabilitationpsychology and Psychotherapy, University of Freiburg, Engelberger Str. 41, Freiburg, 79085, Germany, +49 7612033049, lasse.sander@psychologie.uni-freiburg.de %K prevention %K systematic review %K meta-analysis %K mental disorders %K Internet and mobile-based %D 2016 %7 17.08.2016 %9 Original Paper %J JMIR Ment Health %G English %X Background: Mental disorders are highly prevalent and associated with considerable disease burden and personal and societal costs. However, they can be effectively reduced through prevention measures. The Internet as a medium appears to be an opportunity for scaling up preventive interventions to a population level. Objective: The aim of this study was to systematically summarize the current state of research on Internet-based interventions for the prevention of mental disorders to give a comprehensive overview of this fast-growing field. Methods: A systematic database search was conducted (CENTRAL, Medline, PsycINFO). Studies were selected according to defined eligibility criteria (adult population, Internet-based mental health intervention, including a control group, reporting onset or severity data, randomized controlled trial). Primary outcome was onset of mental disorder. Secondary outcome was symptom severity. Study quality was assessed using the Cochrane Risk of Bias Tool. Meta-analytical pooling of results took place if feasible. Results: After removing duplicates, 1169 studies were screened of which 17 were eligible for inclusion. Most studies examined prevention of eating disorders or depression or anxiety. Two studies on posttraumatic stress disorder and 1 on panic disorder were also included. Overall study quality was moderate. Only 5 studies reported incidence data assessed by means of standardized clinical interviews (eg, SCID). Three of them found significant differences in onset with a number needed to treat of 9.3-41.3. Eleven studies found significant improvements in symptom severity with small-to-medium effect sizes (d=0.11- d=0.76) in favor of the intervention groups. The meta-analysis conducted for depression severity revealed a posttreatment pooled effect size of standardized mean difference (SMD) =−0.35 (95% CI, −0.57 to −0.12) for short-term follow-up, SMD = −0.22 (95% CI, −0.37 to −0.07) for medium-term follow-up, and SMD = −0.14 (95% CI, -0.36 to 0.07) for long-term follow-up in favor of the Internet-based psychological interventions when compared with waitlist or care as usual. Conclusions: Internet-based interventions are a promising approach to prevention of mental disorders, enhancing existing methods. Study results are still limited due to inadequate diagnostic procedures. To be able to appropriately comment on effectiveness, future studies need to report incidence data assessed by means of standardized interviews. Public health policy should promote research to reduce health care costs over the long term, and health care providers should implement existing, demonstrably effective interventions into routine care. %M 27535468 %R 10.2196/mental.6061 %U http://mental.jmir.org/2016/3/e38/ %U https://doi.org/10.2196/mental.6061 %U http://www.ncbi.nlm.nih.gov/pubmed/27535468 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 8 %P e220 %T Efficacy of Internet-Based Self-Monitoring Interventions on Maternal and Neonatal Outcomes in Perinatal Diabetic Women: A Systematic Review and Meta-Analysis %A Lau,Ying %A Htun,Tha Pyai %A Wong,Suei Nee %A Tam,Wai San Wilson %A Klainin-Yobas,Piyanee %+ National University of Singapore, Alice Lee Centre for Nursing Studies, Level 2, Clinical Research Centre, Block MD11, 10 Medical Drive, Singapore, 117597, Singapore, 65 66011603, nurly@nus.edu.sg %K Internet %K pregnancy in diabetics %K interventions %K meta-analysis %D 2016 %7 15.08.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Self-monitoring using the Internet offers new opportunities to engage perinatal diabetic women in self-management to reduce maternal and neonatal complications. Objective: This review aims to synthesize the best available evidence to evaluate the efficacy of Internet-based self-monitoring interventions in improving maternal and neonatal outcomes among perinatal diabetic women. Methods: The review was conducted using Cochrane Central Register of Controlled Trials, PubMed, EMBASE, Cumulative Index to Nursing and Allied Health Literature, PsyINFO, Scopus, and ProQuest Dissertations and Theses to search for English-language research studies without any year limitation. A risk of bias table was used to assess methodological quality. Meta-analysis was performed with RevMan software. Cochran Q and I2 tests were used to assess heterogeneity. The overall effect was assessed using z tests at P<.05. Of the 438 studies identified through electronic searches and reference lists, nine experimental studies from 10 publications were selected. Results: Half of the selected studies showed low risk of bias and comprised 852 perinatal diabetic women in six countries. The meta-analysis revealed that Internet-based self-monitoring interventions significantly decreased the level of maternal glycated hemoglobin A1c (z=2.23, P=.03) compared to usual care among perinatal diabetic women at postintervention. Moreover, Internet-based self-monitoring interventions significantly decreased the cesarean delivery rate (z=2.23, P=.03) compared to usual care among the mixed group at postintervention. Conclusions: This review shows neonatal or other maternal outcomes are similar between Internet-based self-monitoring interventions and usual diabetes care among perinatal diabetic women. The long-term effects of the intervention must be confirmed in future studies using randomized controlled trials and follow-up data. %M 27526637 %R 10.2196/jmir.6153 %U http://www.jmir.org/2016/8/e220/ %U https://doi.org/10.2196/jmir.6153 %U http://www.ncbi.nlm.nih.gov/pubmed/27526637 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 8 %P e223 %T Web-Based Video-Coaching to Assist an Automated Computer-Tailored Physical Activity Intervention for Inactive Adults: A Randomized Controlled Trial %A Alley,Stephanie %A Jennings,Cally %A Plotnikoff,Ronald C %A Vandelanotte,Corneel %+ Physical Activity Research Group, School of Human, Health and Social Sciences, Central Queensland University, Building 77, Bruce Highway, Rockhampton, 4701, Australia, 61 749232263, s.alley@cqu.edu.au %K motor activity %K health promotion %K chronic disease %K e-counseling %K Internet %D 2016 %7 12.08.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based physical activity interventions that apply computer tailoring have shown to improve engagement and behavioral outcomes but provide limited accountability and social support for participants. It is unknown how video calls with a behavioral expert in a Web-based intervention will be received and whether they improve the effectiveness of computer-tailored advice. Objective: The purpose of this study was to determine the feasibility and effectiveness of brief video-based coaching in addition to fully automated computer-tailored advice in a Web-based physical activity intervention for inactive adults. Methods: Participants were assigned to one of the three groups: (1) tailoring + video-coaching where participants received an 8-week computer-tailored Web-based physical activity intervention (“My Activity Coach”) including 4 10-minute coaching sessions with a behavioral expert using a Web-based video-calling program (eg, Skype; n=52); (2) tailoring-only where participants received the same intervention without the coaching sessions (n=54); and (3) a waitlist control group (n=45). Demographics were measured at baseline, intervention satisfaction at week 9, and physical activity at baseline, week 9, and 6 months by Web-based self-report surveys. Feasibility was analyzed by comparing intervention groups on retention, adherence, engagement, and satisfaction using t tests and chi-square tests. Effectiveness was assessed using linear mixed models to compare physical activity changes between groups. Results: A total of 23 tailoring + video-coaching participants, 30 tailoring-only participants, and 30 control participants completed the postintervention survey (83/151, 55.0% retention). A low percentage of tailoring + video-coaching completers participated in the coaching calls (11/23, 48%). However, the majority of those who participated in the video calls were satisfied with them (5/8, 71%) and had improved intervention adherence (9/11, 82% completed 3 or 4 modules vs 18/42, 43%, P=.01) and engagement (110 minutes spent on the website vs 78 minutes, P=.02) compared with other participants. There were no overall retention, adherence, engagement, and satisfaction differences between tailoring + video-coaching and tailoring-only participants. At 9 weeks, physical activity increased from baseline to postintervention in all groups (tailoring + video-coaching: +150 minutes/week; tailoring only: +123 minutes/week; waitlist control: +34 minutes/week). The increase was significantly higher in the tailoring + video-coaching group compared with the control group (P=.01). No significant difference was found between intervention groups and no significant between-group differences were found for physical activity change at 6 months. Conclusions: Only small improvements were observed when video-coaching was added to computer-tailored advice in a Web-based physical activity intervention. However, combined Web-based video-coaching and computer-tailored advice was effective in comparison with a control group. More research is needed to determine whether Web-based coaching is more effective than stand-alone computer-tailored advice. Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN): 12614000339651; http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12614000339651+&isBasic=True (Archived by WebCite at http://www.webcitation.org/6jTnOv0Ld) %M 27520283 %R 10.2196/jmir.5664 %U http://www.jmir.org/2016/8/e223/ %U https://doi.org/10.2196/jmir.5664 %U http://www.ncbi.nlm.nih.gov/pubmed/27520283 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 8 %P e158 %T The Effect of Tailored Web-Based Feedback and Optional Telephone Coaching on Health Improvements: A Randomized Intervention Among Employees in the Transport Service Industry %A Solenhill,Madeleine %A Grotta,Alessandra %A Pasquali,Elena %A Bakkman,Linda %A Bellocco,Rino %A Trolle Lagerros,Ylva %+ Halmstad University, School of Health and Welfare, Box 823, Halmstad, S-301 18, Sweden, 46 +46 35 16 71 00, Madeleine.Solenhill@hh.se %K diet %K exercise %K Internet %K intervention studies %K lifestyle %K motivation %K occupational health %K questionnaires %K randomized %D 2016 %7 11.08.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Lifestyle-related health problems are an important health concern in the transport service industry. Web- and telephone-based interventions could be suitable for this target group requiring tailored approaches. Objective: To evaluate the effect of tailored Web-based health feedback and optional telephone coaching to improve lifestyle factors (body mass index—BMI, dietary intake, physical activity, stress, sleep, tobacco and alcohol consumption, disease history, self-perceived health, and motivation to change health habits), in comparison to no health feedback or telephone coaching. Methods: Overall, 3,876 employees in the Swedish transport services were emailed a Web-based questionnaire. They were randomized into: control group (group A, 498 of 1238 answered, 40.23%), or intervention Web (group B, 482 of 1305 answered, 36.93%), or intervention Web + telephone (group C, 493 of 1333 answered, 36.98%). All groups received an identical questionnaire, only the interventions differed. Group B received tailored Web-based health feedback, and group C received tailored Web-based health feedback + optional telephone coaching if the participants’ reported health habits did not meet the national guidelines, or if they expressed motivation to change health habits. The Web-based feedback was fully automated. Telephone coaching was performed by trained health counselors. Nine months later, all participants received a follow-up questionnaire and intervention Web + telephone. Descriptive statistics, the chi-square test, analysis of variance, and generalized estimating equation (GEE) models were used. Results: Overall, 981 of 1473 (66.60%) employees participated at baseline (men: 66.7%, mean age: 44 years, mean BMI: 26.4 kg/m2) and follow-up. No significant differences were found in reported health habits between the 3 groups over time. However, significant changes were found in motivation to change. The intervention groups reported higher motivation to improve dietary habits (144 of 301 participants, 47.8%, and 165 of 324 participants, 50.9%, for groups B and C, respectively) and physical activity habits (181 of 301 participants, 60.1%, and 207 of 324 participants, 63.9%, for B and C, respectively) compared with the control group A (122 of 356 participants, 34.3%, for diet and 177 of 356 participants, 49.7%, for physical activity). At follow-up, the intervention groups had significantly decreased motivation (group B: P<.001 for change in diet; P<.001 for change in physical activity; group C: P=.007 for change in diet; P<.001 for change in physical activity), whereas the control group reported significantly increased motivation to change diet and physical activity (P<.001 for change in diet; P<.001 for change in physical activity). Conclusion: Tailored Web-based health feedback and the offering of optional telephone coaching did not have a positive health effect on employees in the transport services. However, our findings suggest an increased short-term motivation to change health behaviors related to diet and physical activity among those receiving tailored Web-based health feedback. %M 27514859 %R 10.2196/jmir.4005 %U http://www.jmir.org/2016/8/e158/ %U https://doi.org/10.2196/jmir.4005 %U http://www.ncbi.nlm.nih.gov/pubmed/27514859 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 8 %P e215 %T Long-Term Effects of an Internet-Mediated Pedometer-Based Walking Program for Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial %A Moy,Marilyn L %A Martinez,Carlos H %A Kadri,Reema %A Roman,Pia %A Holleman,Robert G %A Kim,Hyungjin Myra %A Nguyen,Huong Q %A Cohen,Miriam D %A Goodrich,David E %A Giardino,Nicholas D %A Richardson,Caroline R %+ Department of Family Medicine, University of Michigan, 1018 Fuller St., Ann Arbor, MI, 48104, United States, 1 734 998 7120 ext 316, caroli@umich.edu %K bronchitis, chronic %K emphysema %K pulmonary disease, chronic obstructive %K quality of life %K exercise %K motor activity %K Internet %D 2016 %7 08.08.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Regular physical activity (PA) is recommended for persons with chronic obstructive pulmonary disease (COPD). Interventions that promote PA and sustain long-term adherence to PA are needed. Objective: We examined the effects of an Internet-mediated, pedometer-based walking intervention, called Taking Healthy Steps, at 12 months. Methods: Veterans with COPD (N=239) were randomized in a 2:1 ratio to the intervention or wait-list control. During the first 4 months, participants in the intervention group were instructed to wear the pedometer every day, upload daily step counts at least once a week, and were provided access to a website with four key components: individualized goal setting, iterative feedback, educational and motivational content, and an online community forum. The subsequent 8-month maintenance phase was the same except that participants no longer received new educational content. Participants randomized to the wait-list control group were instructed to wear the pedometer, but they did not receive step-count goals or instructions to increase PA. The primary outcome was health-related quality of life (HRQL) assessed by the St George’s Respiratory Questionnaire Total Score (SGRQ-TS); the secondary outcome was daily step count. Linear mixed-effect models assessed the effect of intervention over time. One participant was excluded from the analysis because he was an outlier. Within the intervention group, we assessed pedometer adherence and website engagement by examining percent of days with valid step-count data, number of log-ins to the website each month, use of the online community forum, and responses to a structured survey. Results: Participants were 93.7% male (223/238) with a mean age of 67 (SD 9) years. At 12 months, there were no significant between-group differences in SGRQ-TS or daily step count. Between-group difference in daily step count was maximal and statistically significant at month 4 (P<.001), but approached zero in months 8-12. Within the intervention group, mean 76.7% (SD 29.5) of 366 days had valid step-count data, which decreased over the months of study (P<.001). Mean number of log-ins to the website each month also significantly decreased over the months of study (P<.001). The online community forum was used at least once during the study by 83.8% (129/154) of participants. Responses to questions assessing participants’ goal commitment and intervention engagement were not significantly different at 12 months compared to 4 months. Conclusions: An Internet-mediated, pedometer-based PA intervention, although efficacious at 4 months, does not maintain improvements in HRQL and daily step counts at 12 months. Waning pedometer adherence and website engagement by the intervention group were observed. Future efforts should focus on improving features of PA interventions to promote long-term behavior change and sustain engagement in PA. ClinicalTrial: Clinicaltrials.gov NCT01102777; https://clinicaltrials.gov/ct2/show/NCT01102777 (Archived by WebCite at http://www.webcitation.org/6iyNP9KUC) %M 27502583 %R 10.2196/jmir.5622 %U http://www.jmir.org/2016/8/e215/ %U https://doi.org/10.2196/jmir.5622 %U http://www.ncbi.nlm.nih.gov/pubmed/27502583 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 2 %N 2 %P e33 %T Acceptability of a Community-Based Outreach HIV-Testing Intervention Using Oral Fluid Collection Devices and Web-Based HIV Test Result Collection Among Sub-Saharan African Migrants: A Mixed-Method Study %A Loos,Jasna %A Manirankunda,Lazare %A Platteau,Tom %A Albers,Laura %A Fransen,Katrien %A Vermoesen,Tine %A Namanya,Fiona %A Nöstlinger,Christiana %+ HIV and Sexual Health Unit, Department of Public Health, Institute of Tropical Medicine, Nationalestraat 155, Antwerp, 2000, Belgium, 32 32470718, jloos@itg.be %K oral fluid collection devices %K Web-based HIV test result %K sub-Saharan African migrants %K outreach HIV testing %K acceptability %D 2016 %7 04.08.2016 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: Late human immunodeficiency virus (HIV) diagnosis is common among sub-Saharan African migrants. To address their barriers to HIV testing uptake and improve timely HIV diagnoses and linkage to care, the outreach HIV testing intervention, “swab2know,” was developed. It combined a community-based approach with innovative testing methods: oral fluid self-sampling and the choice between Web-based HIV test result collections using a secured website or post-test counseling at a sexual health clinic. The sessions included an informational speech delivered by a physician of sub-Saharan African origin and testimonies by community members living with HIV. Objectives: The objectives of this study were to evaluate the intervention’s acceptability among sub-Saharan African migrants and its potential to reach subgroups at higher risk for HIV infection and to identify facilitators and barriers for HIV testing uptake. Methods: This mixed-method study combined qualitative (participant observations and informal interviews with testers and nontesters) and quantitative data (paper–pencil survey, laboratory data, and result collection files). Data were analyzed using a content analytical approach for qualitative and univariate analysis for quantitative data. Results: A total of 10 testing sessions were organized in sub-Saharan African migrant community venues in the city of Antwerp, Belgium, between December 2012 and June 2013. Overall, 18.2% of all people present (N=780) underwent HIV testing; 29.8% of them tested for HIV for the first time, 22.3% did not have a general practitioner, and 21.5% reported 2 or more sexual partners (last 3 months). Overall, 56.3% of participants chose to collect their HIV test results via the protected website. In total, 78.9% collected their results. The qualitative analysis of 137 participant observation field notes showed that personal needs and Internet literacy determined the choice of result collection method. Generally, the oral fluid collection devices were well accepted mainly because sub-Saharan African migrants dislike blood taking. For some participants, the method raised concerns about HIV transmission via saliva. The combination of information sessions, testimonies, and oral fluid collection devices was perceived as effectively reducing thresholds to participation. Acceptability of the intervention differed between individual participants and settings. Acceptance was higher among women, in churches and settings where community leaders were engaged in HIV awareness raising. Higher preventive outcomes were observed in settings with lower acceptance. The presence of the intervention team visualized the magnitude of the HIV epidemic to the public and promoted HIV testing uptake at large, for example, those who declined indicated they would take up testing later. Conclusions: When accompanied by tailored provision of information, outreach HIV testing interventions adopting a community-based approach and innovative methods such as Web-based result collection and oral fluid collection devices are acceptable and reduce thresholds for HIV testing uptake. The swab2know intervention was able to reach sub-Saharan African migrants at risk of HIV infection, and with limited access to regular HIV testing. Among nontesters, the intervention contributed to awareness raising and therefore has a place in a multipronged HIV test promotion strategy. %M 27493067 %R 10.2196/publichealth.5519 %U http://publichealth.jmir.org/2016/2/e33/ %U https://doi.org/10.2196/publichealth.5519 %U http://www.ncbi.nlm.nih.gov/pubmed/27493067 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 8 %P e210 %T Integrating Evidence From Systematic Reviews, Qualitative Research, and Expert Knowledge Using Co-Design Techniques to Develop a Web-Based Intervention for People in the Retirement Transition %A O'Brien,Nicola %A Heaven,Ben %A Teal,Gemma %A Evans,Elizabeth H %A Cleland,Claire %A Moffatt,Suzanne %A Sniehotta,Falko F %A White,Martin %A Mathers,John C %A Moynihan,Paula %+ Institute of Health and Society, Centre for Oral Health Research, Newcastle University, Framlington Place, Newcastle upon Tyne, NE24BW, United Kingdom, 44 1912088241, paula.moynihan@ncl.ac.uk %K intervention studies %K health behavior %K retirement %K Internet %D 2016 %7 03.08.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Integrating stakeholder involvement in complex health intervention design maximizes acceptability and potential effectiveness. However, there is little methodological guidance about how to integrate evidence systematically from various sources in this process. Scientific evidence derived from different approaches can be difficult to integrate and the problem is compounded when attempting to include diverse, subjective input from stakeholders. Objective: The intent of the study was to describe and appraise a systematic, sequential approach to integrate scientific evidence, expert knowledge and experience, and stakeholder involvement in the co-design and development of a complex health intervention. The development of a Web-based lifestyle intervention for people in retirement is used as an example. Methods: Evidence from three systematic reviews, qualitative research findings, and expert knowledge was compiled to produce evidence statements (stage 1). Face validity of these statements was assessed by key stakeholders in a co-design workshop resulting in a set of intervention principles (stage 2). These principles were assessed for face validity in a second workshop, resulting in core intervention concepts and hand-drawn prototypes (stage 3). The outputs from stages 1-3 were translated into a design brief and specification (stage 4), which guided the building of a functioning prototype, Web-based intervention (stage 5). This prototype was de-risked resulting in an optimized functioning prototype (stage 6), which was subject to iterative testing and optimization (stage 7), prior to formal pilot evaluation. Results: The evidence statements (stage 1) highlighted the effectiveness of physical activity, dietary and social role interventions in retirement; the idiosyncratic nature of retirement and well-being; the value of using specific behavior change techniques including those derived from the Health Action Process Approach; and the need for signposting to local resources. The intervention principles (stage 2) included the need to facilitate self-reflection on available resources, personalization, and promotion of links between key lifestyle behaviors. The core concepts and hand-drawn prototypes (stage 3) had embedded in them the importance of time use and work exit planning, personalized goal setting, and acceptance of a Web-based intervention. The design brief detailed the features and modules required (stage 4), guiding the development of wireframes, module content and functionality, virtual mentors, and intervention branding (stage 5). Following an iterative process of intervention testing and optimization (stage 6), the final Web-based intervention prototype of LEAP (Living, Eating, Activity, and Planning in retirement) was produced (stage 7). The approach was resource intensive and required a multidisciplinary team. The design expert made an invaluable contribution throughout the process. Conclusions: Our sequential approach fills an important methodological gap in the literature, describing the stages and techniques useful in developing an evidence-based complex health intervention. The systematic and rigorous integration of scientific evidence, expert knowledge and experience, and stakeholder input has resulted in an intervention likely to be acceptable and feasible. %M 27489143 %R 10.2196/jmir.5790 %U http://www.jmir.org/2016/8/e210/ %U https://doi.org/10.2196/jmir.5790 %U http://www.ncbi.nlm.nih.gov/pubmed/27489143 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 8 %P e194 %T The Effect of Guided Web-Based Cognitive Behavioral Therapy on Patients With Depressive Symptoms and Heart Failure: A Pilot Randomized Controlled Trial %A Lundgren,Johan Gustav %A Dahlström,Örjan %A Andersson,Gerhard %A Jaarsma,Tiny %A Kärner Köhler,Anita %A Johansson,Peter %+ Division of Nursing Science, Department of Social and Welfare Studies, Linköping University, Department of Social and Welfare Studies, Linköping University, Norrköping, SE 601 74, Sweden, 46 011363592, johan.lundgren@liu.se %K heart failure %K depression %K Internet-based cognitive behavioral therapy %K cognitive behavioral therapy %K Internet %K eHealth %D 2016 %7 03.08.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Depressive symptoms, and the associated coexistence of symptoms of anxiety and decreased quality of life (QoL), are common in patients with heart failure (HF). However, treatment strategies for depressive symptoms in patients with HF still remain to be established. Internet-based cognitive behavioral therapy (ICBT), as guided self-help CBT programs, has shown good effects in the treatment of depression. Until now, ICBT has not been evaluated in patients with HF with depressive symptoms. Objective: The aims of this study were to (1) evaluate the effect of a 9-week guided ICBT program on depressive symptoms in patients with HF; (2) investigate the effect of the ICBT program on cardiac anxiety and QoL; and (3) assess factors associated with the change in depressive symptoms. Methods: Fifty participants were randomized into 2 treatment arms: ICBT or a Web-based moderated discussion forum (DF). The Patient Health Questionnaire-9 was used to measure depressive symptoms, the Cardiac Anxiety Questionnaire (CAQ) was used to measure cardiac-related anxiety, and the Minnesota Living with Heart Failure questionnaire was used to measure QoL. Data were collected at baseline and at follow-up at the end of the 9-week intervention. Intention-to-treat analysis was used, and missing data were imputed by the Expectation-Maximization method. Between-group differences were determined by analysis of covariance with control for baseline score and regression to the mean. Results: No significant difference in depressive symptoms between the ICBT and the DF group at the follow-up was found, [F(1,47)=1.63, P=.21] and Cohen´s d=0.26. Secondary within-group analysis of depressive symptoms showed that such symptoms decreased significantly in the ICBT group from baseline to the follow-up (baseline M=10.8, standard deviation [SD]=5.7 vs follow-up M=8.6, SD=4.6, t(24)=2.6, P=.02, Cohen´s d=0.43), whereas in the DF group, there was no significant change (baseline M=10.6, SD=5.0, vs follow-up M=9.8, SD=4.3, t(24)=0.93, P=.36. Cohen´s d=0.18). With regard to CAQ and QoL no significant differences were found between the groups (CAQ [d(1,47)=0.5, P=.48] and QoL [F(1,47)=2.87, P=.09]). In the ICBT group in the CAQ subscale of fear, a significant within-group decrease was shown (baseline M=1.55 vs follow-up M=1.35, P=.04). In the ICBT group, the number of logins to the Web portal correlated significantly with improvement in depressive symptoms (P=.02), whereas higher age (P=.01) and male sex (P=.048) were associated with less change in depressive symptoms. This study is underpowered because of difficulties in the recruitment of patients. Conclusions: Guided ICBT adapted for persons with HF and depressive symptoms was not statistically superior to participation in a Web-based DF. However, within the ICBT group, a statically significant improvement of depressive symptoms was detected. ClinicalTrial: Clinicaltrials.gov NCT01681771; https://clinicaltrials.gov/ct2/show/NCT01681771 (Archived by WebCite at http://www.webcitation.org/6ikzbcuLN) %M 27489077 %R 10.2196/jmir.5556 %U http://www.jmir.org/2016/8/e194/ %U https://doi.org/10.2196/jmir.5556 %U http://www.ncbi.nlm.nih.gov/pubmed/27489077 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e159 %T A Social Media Peer Group Intervention for Mothers to Prevent Obesity and Promote Healthy Growth from Infancy: Development and Pilot Trial %A Gruver,Rachel S %A Bishop-Gilyard,Chanelle T %A Lieberman,Alexandra %A Gerdes,Marsha %A Virudachalam,Senbagam %A Suh,Andrew W %A Kalra,Gurpreet K %A Magge,Sheela N %A Shults,Justine %A Schreiner,Mark S %A Power,Thomas J %A Berkowitz,Robert I %A Fiks,Alexander G %+ Division of General Pediatrics, The Children's Hospital of Philadelphia, 3535 Market St., Rm 1546, Philadelphia, PA, 19104, United States, 1 267 426 2304, fiks@email.chop.edu %K obesity %K social media %K behavior change %K intervention %K internet %K peer group %K pediatrics %K prevention and control %K infant %K mothers %D 2016 %7 02.08.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Evidence increasingly indicates that childhood obesity prevention efforts should begin as early as infancy. However, few interventions meet the needs of families whose infants are at increased obesity risk due to factors including income and maternal body mass index (BMI). Social media peer groups may offer a promising new way to provide these families with the knowledge, strategies, and support they need to adopt obesity prevention behaviors. Objective: The aim of this study is to develop and pilot test a Facebook-based peer group intervention for mothers, designed to prevent pediatric obesity and promote health beginning in infancy. Methods: We conducted in-depth semi-structured interviews with 29 mothers of infants and focus groups with 30 pediatric clinicians, to inform the development of a theory-based intervention. We then conducted a single-group pilot trial with 8 mothers to assess its feasibility and acceptability. All participants were recruited offline at pediatric primary care practices. Participants in the pilot trial joined a private Facebook group, moderated by a psychologist, with a weekly video-based curriculum, and also had the option to meet at a face-to-face event. Within the Facebook group, mothers were encouraged to chat, ask questions, and share photos and videos of themselves and babies practicing healthy behaviors. Consistent with the literature on obesity prevention, the curriculum addressed infant feeding, sleep, activity, and maternal well-being. Feasibility was assessed using the frequency and content of group participation by mothers, and acceptability was measured using online surveys and phone interviews. Results: Based on preferences of mothers interviewed (mean BMI 35 kg/m2, all Medicaid-insured, mean age 27, all Black), we designed the intervention to include frequent posts with new information, videos showing parents of infants demonstrating healthy behaviors, and an optional face-to-face meeting. We developed a privacy and safety plan that met the needs of participants as well as the requirements of the local institutional review board (IRB), which included use of a “secret” group and frequent screening of participant posts. Clinicians, 97% (29/30) women and 87% (26/30) pediatricians, preferred no direct involvement in the intervention, but were supportive of their patients’ participation. In our 8-week, single group pilot trial, all participants (mean BMI 35 kg/m2, all Medicaid-insured, mean age 28, all Black) viewed every weekly video post, and interacted frequently, with a weekly average of 4.4 posts/comments from each participant. All participant posts were related to parenting topics. Participants initiated conversations about behaviors related to healthy infant growth including solid food introduction, feeding volume, and managing stress. All 8 pilot group participants reported that they found the group helpful and would recommend it to others. Conclusions: Our methodology was feasible and acceptable to low-income mothers of infants at high risk of obesity, and could be adapted to implement peer groups through social media for underserved populations in varied settings. ClinicalTrial: ClinicalTrials.gov NCT01977105; https://clinicaltrials.gov/ct2/show/NCT01977105 (Archived by WebCite at http://www.webcitation.org/6iMFfOBat) %M 27485934 %R 10.2196/resprot.5276 %U http://www.researchprotocols.org/2016/3/e159/ %U https://doi.org/10.2196/resprot.5276 %U http://www.ncbi.nlm.nih.gov/pubmed/27485934 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 4 %N 3 %P e93 %T The Empowering Role of Mobile Apps in Behavior Change Interventions: The Gray Matters Randomized Controlled Trial %A Hartin,Phillip J %A Nugent,Chris D %A McClean,Sally I %A Cleland,Ian %A Tschanz,JoAnn T %A Clark,Christine J %A Norton,Maria C %+ Computer Science Research Institute, Ulster University, Room 16J26, University of Ulster, Newtownabbey, BT37 0QB, United Kingdom, 44 28 9036 8840, pj.hartin@ulster.ac.uk %K behavior %K health behavior %K behavior change %K motivation %K Alzheimer disease %K smartphone %D 2016 %7 02.08.2016 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Health education and behavior change programs targeting specific risk factors have demonstrated their effectiveness in reducing the development of future diseases. Alzheimer disease (AD) shares many of the same risk factors, most of which can be addressed via behavior change. It is therefore theorized that a behavior change intervention targeting these risk factors would likely result in favorable rates of AD prevention. Objective: The objective of this study was to reduce the future risk of developing AD, while in the short term promoting vascular health, through behavior change. Methods: The study was an interventional randomized controlled trial consisting of subjects who were randomly assigned into either treatment (n=102) or control group (n=42). Outcome measures included various blood-based biomarkers, anthropometric measures, and behaviors related to AD risk. The treatment group was provided with a bespoke “Gray Matters” mobile phone app designed to encourage and facilitate behavior change. The app presented evidence-based educational material relating to AD risk and prevention strategies, facilitated self-reporting of behaviors across 6 behavioral domains, and presented feedback on the user’s performance, calculated from reported behaviors against recommended guidelines. Results: This paper explores the rationale for a mobile phone–led intervention and details the app’s effect on behavior change and subsequent clinical outcomes. Via the app, the average participant submitted 7.3 (SD 3.2) behavioral logs/day (n=122,719). Analysis of these logs against primary outcome measures revealed that participants who improved their high-density lipoprotein cholesterol levels during the study duration answered a statistically significant higher number of questions per day (mean 8.30, SD 2.29) than those with no improvement (mean 6.52, SD 3.612), t97.74=−3.051, P=.003. Participants who decreased their body mass index (BMI) performed significantly better in attaining their recommended daily goals (mean 56.21 SD 30.4%) than those who increased their BMI (mean 40.12 SD 29.1%), t80 = −2.449, P=.017. In total, 69.2% (n=18) of those who achieved a mean performance percentage of 60% or higher, across all domains, reduced their BMI during the study, whereas 60.7% (n=34) who did not, increased their BMI. One-way analysis of variance of systolic blood pressure category changes showed a significant correlation between reported efforts to reduce stress and category change as a whole, P=.035. An exit survey highlighted that respondents (n=83) reported that the app motivated them to perform physical activity (85.4%) and make healthier food choices (87.5%). Conclusions: In this study, the ubiquitous nature of the mobile phone excelled as a delivery platform for the intervention, enabling the dissemination of educational intervention material while simultaneously monitoring and encouraging positive behavior change, resulting in desirable clinical effects. Sustained effort to maintain the achieved behaviors is expected to mitigate future AD risk. Trial Registration: ClinicalTrails.gov NCT02290912; https://clinicaltrials.gov/ct2/show/NCT02290912 (Archived by WebCite at http://www.webcitation.org/6ictUEwnm) %M 27485822 %R 10.2196/mhealth.4878 %U http://mhealth.jmir.org/2016/3/e93/ %U https://doi.org/10.2196/mhealth.4878 %U http://www.ncbi.nlm.nih.gov/pubmed/27485822 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 7 %P e206 %T An Integrated Process and Outcome Evaluation of a Web-Based Communication Tool for Patients With Malignant Lymphoma: Randomized Controlled Trial %A van Bruinessen,Inge Renske %A van Weel-Baumgarten,Evelyn M %A Gouw,Hans %A Zijlstra,Josée M %A van Dulmen,Sandra %+ NIVEL Netherlands Institute for Health Services Research, Otterstraat 118-124, Utrecht, 3500 BN, Netherlands, 31 302729680, i.vanbruinessen@nivel.nl %K RCT %K communication aid %K Web-based intervention %K self-help application %K hematologic malignancies %K lymphoma cancer %K patient participation %D 2016 %7 29.07.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: The complex nature of the medical dialogue and the often emotional context in cancer care present challenges to health care professionals (HCPs) and patients. Patients are increasingly expected to be informed participants and to be able to make conscious decisions, which they often find very difficult. In an attempt to support patients with malignant lymphoma in clinical communication, we developed a stand-alone, Web-based intervention called “PatientTIME.” The development of PatientTIME was based on a participatory intervention mapping framework. Its primary aim is to boost patients’ self-efficacy in patient-professional communication (ie, their confidence when interacting with their HCP). Patients can use this intervention before their hospital visit to prepare for their clinical consultation. PatientTIME is fully automated and use is patient-initiated. Objective: The aim of this study was to evaluate if and in what way patients benefit from PatientTIME and if it enhances their confidence in clinical communication. Methods: The intervention was evaluated in a closed randomized controlled trial with continuous recruitment (using online and offline methods to reach potential participants) and data collection. In accordance with the Medical Research Council guidance, we started with a process evaluation. Subsequently, an outcome evaluation was performed focusing on the patients’ perceived confidence in communication with their HCP, measured with the validated PEPPI questionnaire at baseline and at 3 months after participation. Process and outcome data were obtained through Web-based questionnaires, log files (automatically generated files mapping the interactions between program and users), and a logbook (comprising a record of actions and interactions kept by the researchers). Participants were not blinded. A total of 146 patients registered online, of whom 97 gave their informed consent and were assigned at random to the control group (N=34) or 1 of the 2 intervention groups (N=63). Ultimately 87/97 (90%) of these patients actually participated in the study, producing 87 datasets for analysis. Results: More than half of the intervention group patients reported that the intervention helped them prepare for a clinical consultation; it created awareness about the importance of communication and reinforced their existing communication skills. In the postvisit test, the control group showed a small, nonsignificant improvement in perceived communication efficacy. The intervention group showed a significant improvement in perceived efficacy. However, the interaction effect was not significant, indicating that the improvement solely as a result of the intervention may not be significant. Conclusions: A considerable number of patients reported that PatientTIME did provide support. We found a trend indicating that in the long run, patients with access to PatientTIME scored better on the perceived efficacy scale than patients without access. However, at this stage we cannot conclude that PatientTIME improves patients’ confidence when interacting with HCPs. ClinicalTrial: Netherlands National Trial Register (NTR): 3779; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3779 (archived by WebCite at http://www.webcitation.org/6iztxJ5Nt) %M 27473173 %R 10.2196/jmir.5877 %U http://www.jmir.org/2016/7/e206/ %U https://doi.org/10.2196/jmir.5877 %U http://www.ncbi.nlm.nih.gov/pubmed/27473173 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e151 %T Use of Relational Agents to Improve Family Communication in Type 1 Diabetes: Methods %A Thompson,Debbe %A Cullen,Karen W %A Redondo,Maria J %A Anderson,Barbara %+ USDA/ARS Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine, 1100 Bates St, Houston, TX, 77030, United States, 1 713 798 7076, dit@bcm.edu %K adolescents %K family communication %K pre-adolescents %K relational agent %K type 1 diabetes %D 2016 %7 28.07.2016 %9 Proposal %J JMIR Res Protoc %G English %X Background: Physiological and environmental risk factors interact to undermine blood glucose control during early adolescence. This has been documented to be associated with family conflict and poor adherence to diabetes management tasks. Family Teamwork is an efficacious program demonstrated to enhance family communication and reduce conflict during this vulnerable period. It was designed to be delivered to families in-person, which limited reach and potential impact. Objective: The purpose of this paper is to present the protocol for adapting Family Teamwork for Web-based delivery. Methods: Formative research with health care providers, parents, and adolescents will help modify Family Teamwork for Web-based delivery by a relational agent (ie, a computerized character with human-like features and actions). Sessions will be interactive, requiring both parent and adolescent participation, with the relational agent serving as a health coach. After programming, usability testing will be conducted to help ensure the program is easy to use. Video and instructional materials will be developed to facilitate use, and a small pilot study will be conducted to assess feasibility. Families will provide written informed consent prior to participation in any phase of the study. The Institutional Review Board at Baylor College of Medicine reviewed and approved the protocol (H-37245). Results: Formative research is underway. No results are available at this time. Conclusions: This research has the potential to make an important contribution to diabetes management by using technology to enhance the reach of an efficacious program. %M 27468762 %R 10.2196/resprot.5817 %U http://www.researchprotocols.org/2016/3/e151/ %U https://doi.org/10.2196/resprot.5817 %U http://www.ncbi.nlm.nih.gov/pubmed/27468762 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 7 %P e209 %T A Mobile Ecological Momentary Assessment Tool (devilSPARC) for Nutrition and Physical Activity Behaviors in College Students: A Validation Study %A Bruening,Meg %A van Woerden,Irene %A Todd,Michael %A Brennhofer,Stephanie %A Laska,Melissa N %A Dunton,Genevieve %+ Arizona State University, 550 N 5th Street, Phoenix, AZ, 85004, United States, 1 602 827 2266, meg.bruening@asu.edu %K validation study %K ecological momentary assessment %K nutritional status %K physical activity %K sedentary activity %K emerging adults %D 2016 %7 27.07.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: The majority of nutrition and physical activity assessments methods commonly used in scientific research are subject to recall and social desirability biases, which result in over- or under-reporting of behaviors. Real-time mobile-based ecological momentary assessments (mEMAs) may result in decreased measurement biases and minimize participant burden. Objective: The aim was to examine the validity of a mEMA methodology to assess dietary and physical activity levels compared to 24-hour dietary recalls and accelerometers. Methods: This study was a pilot test of the SPARC (Social impact of Physical Activity and nutRition in College) study, which aimed to determine the mechanism by which friendship networks impact weight-related behaviors among young people. An mEMA app, devilSPARC, was developed to assess weight-related behaviors in real time. A diverse sample of 109 freshmen and community mentors attending a large southwestern university downloaded the devilSPARC mEMA app onto their personal mobile phones. Participants were prompted randomly eight times per day over the course of 4 days to complete mEMAs. During the same 4-day period, participants completed up to three 24-hour dietary recalls and/or 4 days of accelerometry. Self-reported mEMA responses were compared to 24-hour dietary recalls and accelerometry measures using comparison statistics, such as match rate, sensitivity and specificity, and mixed model odds ratios, adjusted for within-person correlation among repeated measurements. Results: At the day level, total dietary intake data reported through the mEMA app reflected eating choices also captured by the 24-hour recall. Entrées had the lowest match rate, and fruits and vegetables had the highest match rate. Widening the window of aggregation of 24-hour dietary recall data on either side of the mEMA response resulted in increased specificity and decreased sensitivity. For physical activity behaviors, levels of activity reported through mEMA differed for sedentary versus non-sedentary activity at the day level as measured by accelerometers. Conclusions: The devilSPARC mEMA app is valid for assessing eating behaviors and the presence of sedentary activity at the day level. This mEMA may be useful in studies examining real-time weight-related behaviors. %M 27465701 %R 10.2196/jmir.5969 %U http://www.jmir.org/2016/7/e209/ %U https://doi.org/10.2196/jmir.5969 %U http://www.ncbi.nlm.nih.gov/pubmed/27465701 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 7 %P e139 %T Web-Based Interventions for Chronic Back Pain: A Systematic Review %A Garg,Shashank %A Garg,Divya %A Turin,Tanvir C %A Chowdhury,M Faruq U %+ Department of Family Medicine, University of Calgary, Room G012, Health Sciences Center, 3330 Hospital Drive Northwest,, Calgary, AB, T2N 4N1, Canada, 1 403 210 7199, sgarg@ucalgary.ca %K Internet %K chronic back pain %K Web-based interventions %K systematic review %K cognitive behavioral therapy %K empowerment %K disability %D 2016 %7 26.07.2016 %9 Review %J J Med Internet Res %G English %X Background: Chronic low back pain is one of the most common presenting complaints to a physician’s office. Treatment is often challenging and recovery depends on various factors, often resulting in significant investments of time and resources. Objective: The aim of this review is to determine which Web-based interventions aimed at chronic low back pain are of benefit to patients. Methods: Randomized controlled trials (RCTs) studying Web-based interventions directed at adults with chronic low back pain were included. Retrospective studies, narrative reviews, nonrandomized trials, and observational studies were excluded. Electronic databases and bibliographies were searched. Results: In total, nine unique RCTs were identified (total participants=1796). The number of patients randomized in each trial ranged from 51 to 580. Four trials studied online cognitive behavioral therapy (CBT) and five trials studied other Web-based interventions with interactive features. Empowerment/control was improved in six studies. Use of CBT was associated with reduced catastrophization among patients. Mixed results were reported with regards to reduction in pain levels and disability, although some studies showed promise in reducing disability in the short term. One study that measured health care utilization reported reduced utilization with the use of moderated email discussion. Conclusions: Limited data are available regarding effective Web-based interventions to improve outcomes for patients with chronic low back pain. Nine RCTs with small sample sizes were identified in this review. Online CBT appears to show some promise in terms of reducing catastrophization and improving patient attitudes. Further research in this area with larger-scale studies focusing on appropriate outcomes appears to be a priority. %M 27460413 %R 10.2196/jmir.4932 %U http://www.jmir.org/2016/7/e139/ %U https://doi.org/10.2196/jmir.4932 %U http://www.ncbi.nlm.nih.gov/pubmed/27460413 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 3 %N 3 %P e33 %T Feasibility and Outcomes of an Internet-Based Mindfulness Training Program: A Pilot Randomized Controlled Trial %A Kvillemo,Pia %A Brandberg,Yvonne %A Bränström,Richard %+ Department of Clinical Neuroscience, Karolinska Institutet, Berzeliusväg 3, plan 6, Stockholm,, Sweden, 46 7 067 348 64, pia.kvillemo@ki.se %K mindfulness %K Internet-based intervention %K Internet %K usability %K acceptability %K feasibility %K randomized controlled trial %D 2016 %7 22.07.2016 %9 Original Paper %J JMIR Ment Health %G English %X Background: Interventions based on meditation and mindfulness techniques have been shown to reduce stress and increase psychological well-being in a wide variety of populations. Self-administrated Internet-based mindfulness training programs have the potential to be a convenient, cost-effective, easily disseminated, and accessible alternative to group-based programs. Objective: This randomized controlled pilot trial with 90 university students in Stockholm, Sweden, explored the feasibility, usability, acceptability, and outcomes of an 8-week Internet-based mindfulness training program. Methods: Participants were randomly assigned to either an intervention (n=46) or an active control condition (n=44). Intervention participants were invited to an Internet-based 8-week mindfulness program, and control participants were invited to an Internet-based 4-week expressive writing program. The programs were automated apart from weekly reminders via email. Main outcomes in pre- and postassessments were psychological well-being and depression symptoms. To assess the participant’s experiences, those completing the full programs were asked to fill out an assessment questionnaire and 8 of the participants were interviewed using a semistructured interview guide. Descriptive and inferential statistics, as well as content analysis, were performed. Results: In the mindfulness program, 28 out of 46 students (60%) completed the first week and 18 out of 46 (39%) completed the full program. In the expressive writing program, 35 out of 44 students (80%) completed the first week and 31 out of 44 (70%) completed the full program. There was no statistically significantly stronger intervention effect for the mindfulness intervention compared to the active control intervention. Those completing the mindfulness group reported high satisfaction with the program. Most of those interviewed were satisfied with the layout and technique and with the support provided by the study coordinators. More frequent contact with study coordinators was suggested as a way to improve program adherence and completion. Most participants considered the program to be meaningful and helpful but also challenging. The flexibility in performing the exercises at a suitable time and place was appreciated. A major difficulty was, however, finding enough time to practice. Conclusions: The program was usable, acceptable, and showed potential for increasing psychological well-being for those completing it. However, additional modification of the program might be needed to increase retention and compliance. ClinicalTrial: ClinicalTrials.gov NCT02062762; https://clinicaltrials.gov/ct2/show/NCT0206276 (Archived by WebCite at http://www.webcitation.org/6j9I5SGJ4) %M 27450466 %R 10.2196/mental.5457 %U http://mental.jmir.org/2016/3/e33/ %U https://doi.org/10.2196/mental.5457 %U http://www.ncbi.nlm.nih.gov/pubmed/27450466 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 7 %P e203 %T Parent-Focused Childhood and Adolescent Overweight and Obesity eHealth Interventions: A Systematic Review and Meta-Analysis %A Hammersley,Megan L %A Jones,Rachel A %A Okely,Anthony D %+ Early Start Research Institute, Faculty of Social Sciences, University of Wollongong, Building 21, Northfields Ave, Wollongong, 2522, Australia, 61 403233875, megan.hammersley1@uowmail.edu.au %K overweight %K obesity %K child %K adolescent %K internet %K web %K online %K computer %K IVR %K telemedicine %K healthy lifestyle %K dietary intake %K physical activity %D 2016 %7 21.7.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Effective broad-reach interventions to reduce childhood obesity are needed, but there is currently little consensus on the most effective approach. Parental involvement in interventions appears to be important. The use of eHealth modalities in interventions also seems to be promising. To our knowledge, there have been no previous reviews that have specifically investigated the effectiveness of parent-focused eHealth obesity interventions, a gap that this systematic review and meta-analysis intends to address. Objective: The objective of this study was to review the evidence for body mass index (BMI)/BMI z-score improvements in eHealth overweight and obesity randomized controlled trials for children and adolescents, where parents or carers were an agent of change. Methods: A systematic review and meta-analysis was conducted, which conforms to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. Seven databases were searched for the period January 1995 to April 2015. Primary outcome measures were BMI and/or BMI z-score at baseline and post-intervention. Secondary outcomes included diet, physical activity, and screen time. Interventions were included if they targeted parents of children and adolescents aged 0-18 years of age and used an eHealth medium such as the Internet, interactive voice response (IVR), email, social media, telemedicine, or e-learning. Results: Eight studies were included, involving 1487 parent and child or adolescent dyads. A total of 3 studies were obesity prevention trials, and 5 were obesity treatment trials. None of the studies found a statistically significant difference in BMI or BMI z-score between the intervention and control groups at post-intervention, and a meta-analysis demonstrated no significant difference in the effects of parent-focused eHealth obesity interventions compared with a control on BMI/BMI z-score (Standardized Mean Difference −0.15, 95% CI −0.45 to 0.16, Z=0.94, P=.35). Four of seven studies that reported on dietary outcomes demonstrated significant improvements in at least 1 dietary measurement, and 1 of 6 studies that reported on physical activity outcomes demonstrated significant improvements compared with the control. The quality of the interventions was generally not high; therefore, these results should be interpreted with caution. Conclusion: It is recommended that larger, longer duration, high-quality parent-focused eHealth studies are conducted, which transform successful components from face-to-face interventions into an eHealth format and target younger age groups in particular. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews: CRD42015019837; http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42015019837 (Archived by WebCite at http://www.webcitation.org/6ivBHvBhq) %M 27443862 %R 10.2196/jmir.5893 %U http://www.jmir.org/2016/7/e203/ %U https://doi.org/10.2196/jmir.5893 %U http://www.ncbi.nlm.nih.gov/pubmed/27443862 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 7 %P e136 %T Innovatively Supporting Teachers’ Implementation of School-Based Sex Education: Developing A Web-Based Coaching Intervention From Problem to Solution %A Schutte,Lisette %A van den Borne,Marieke %A Kok,Gerjo %A Meijer,Suzanne %A Mevissen,Fraukje EF %+ Maastricht University, Department of Work and Social Psychology, Faculty of Psychology and Neuroscience, PO Box 616, 6200 MD, Maastricht,, Netherlands, 31 4338 81 908, lisette.schutte@maastrichtuniversity.nl %K implementation %K web-based coaching %K intervention mapping %K sexual education %K unobtrusive %K fidelity %K teachers %D 2016 %7 12.07.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Full program implementation is crucial for effectiveness but is often overlooked or insufficiently considered during development of behavioral change interventions. For school-based health promotion programs, teachers are key players in program implementation, but teacher support in this phase is mostly limited to technical support and information. To ensure optimal implementation of the Dutch school-based sexual health program Long Live Love, a Web-based coaching website was developed to support teachers in completeness and fidelity of program implementation. Objective: The aim of this paper is to provide insight into the process of systematic development of a Web-based coaching intervention to support teachers in their implementation of a school-based sexual health program. Methods: The intervention mapping (IM) protocol was applied for the development of a theory- and evidence-based intervention. The IM process begins with (1) a needs assessment, followed by (2) the formulation of change objectives, (3) the selection of theory-based intervention methods and practical applications that take the parameters for effectiveness into consideration, (4) integration of practical applications into an organized program, (5) planning for adoption, implementation, and sustainability of the program, and finally, (6) generating an evaluation plan to measure program effectiveness. Results: Teacher’s implementation behavior was characterized by inconsistently selecting parts of the program and not delivering (all) lessons as intended by program developers. Teachers, however, did not perceive this behavior as problematic, revealing the discrepancy between teacher’s actual and perceived need for support in delivering Long Live Love lessons with completeness and fidelity. Teachers did, however, acknowledge different difficulties they encountered which could potentially negatively influence the quality of implementation. With the IM protocol, this Web-based coaching intervention was developed based on a concept of unobtrusive coaching, by and for teachers, to bring about change in teachers’ implementation behavior. Conclusions: This paper provides an example of a Web-based intervention to bring about behavioral change in a target group of intermediaries who lack intrinsic motivation for coaching and who’s perceptions differ from their actual problematic behavior. The IM protocol is a useful tool for guiding the scientific development of interventions and making them compatible with the needs and preferences of the target group. %M 27405241 %R 10.2196/jmir.5058 %U http://www.jmir.org/2016/7/e136/ %U https://doi.org/10.2196/jmir.5058 %U http://www.ncbi.nlm.nih.gov/pubmed/27405241 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e142 %T Young Adult Utilization of a Smoking Cessation Website: An Observational Study Comparing Young and Older Adult Patterns of Use %A Cantrell,Jennifer %A Ilakkuvan,Vinu %A Graham,Amanda L %A Richardson,Amanda %A Xiao,Haijun %A Mermelstein,Robin J %A Curry,Susan J %A Sporer,Amy K %A Vallone,Donna M %+ Evaluation Science and Research, Truth Initiative, 900 G Street, Fourth Floor, Washington, DC,, United States, 1 202 454 5798, jcantrell@truthinitiative.org %K young adults, smoking cessation, Internet, utilization %D 2016 %7 11.07.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: There is little research on how young adults or young adult subgroups utilize and engage with Web-based cessation interventions when trying to quit smoking. Addressing this knowledge gap is important to identify opportunities to optimize the effectiveness of online cessation programs across diverse young adult users. Objective: This study examines utilization of the BecomeAnEX.org smoking cessation website among young adults and young adult subgroups compared with older adults to identify patterns of use by age, gender, and race/ethnicity. Methods: Study participants were 5983 new registered users on a free smoking cessation website who were aged 18 to 70 years. Website utilization was tracked for 6 months; metrics of use included website visits, pages per visit, length of visit, and interaction with specific website features. Differences in website use by age were examined via bivariate analyses and multivariate logistic regression adjusted for age, gender, and race/ethnicity. Interactions were examined to determine differences by gender and race/ethnicity within young (18- to 24-year-olds and 25- to 34-year-olds) and older (35 years and older) adult segments. Results: A greater percentage of young adults aged 18 to 34 years visited the site only once compared with older adults aged 35 years and older (72.05% vs 56.59%, respectively; P<.001). Young adults also spent less time on the site and viewed fewer pages than older adults. In adjusted analyses, young adults were significantly less likely than older adults to visit the site more than once (18-24 years: adjusted odds ratio [AOR] 0.58, 95% CI 0.49-0.68, P<.001; 25-34 years: AOR 0.56, 95% CI 0.50-0.64, P<.001), spend more than 3 minutes on the site (18-24 years: AOR 0.67, 95% CI 0.57-0.79, P<.001; 25-34 years: AOR 0.56, 95% CI 0.49-0.64, P<.001), view 12 or more pages (18-24 years: AOR 0.72, 95% CI 0.61-0.83; P<.001; 25-34 years: AOR 0.67, 95% CI 0.59-0.76, P<.001), utilize the BecomeAnEX.org community (18-24 years: AOR 0.61, 95% CI 0.48-0.79, P<.001; 25-34 years: AOR 0.73, 95% CI 0.60-0.88, P<.001), or utilize Separation Exercises (18-24 years: AOR 0.68, 95% CI 0.51-0.89, P<.01; 25-34 years: AOR 0.77, 95% CI 0.63-0.94, P<.01). Gender differences in utilization were more pronounced among young adults compared with older adults, with lower levels of utilization among young men than young women. For all age groups, utilization was higher among whites and African Americans than among Hispanics and other racial minorities, with one exception—BecomeAnEX.org community utilization was significantly higher among Hispanic young adults compared with white and African American young adults. Conclusions: Results point to important areas of inquiry for future research and development efforts. Research should focus on enhancing demand and increasing engagement among younger adults and men, examining strategies for capitalizing on young adult developmental needs, and increasing utilization of effective site features among diverse young adult users. %M 27401019 %R 10.2196/resprot.4881 %U http://www.researchprotocols.org/2016/3/e142/ %U https://doi.org/10.2196/resprot.4881 %U http://www.ncbi.nlm.nih.gov/pubmed/27401019 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 6 %P e150 %T A Dietary Feedback System for the Delivery of Consistent Personalized Dietary Advice in the Web-Based Multicenter Food4Me Study %A Forster,Hannah %A Walsh,Marianne C %A O'Donovan,Clare B %A Woolhead,Clara %A McGirr,Caroline %A Daly,E.J %A O'Riordan,Richard %A Celis-Morales,Carlos %A Fallaize,Rosalind %A Macready,Anna L %A Marsaux,Cyril F M %A Navas-Carretero,Santiago %A San-Cristobal,Rodrigo %A Kolossa,Silvia %A Hartwig,Kai %A Mavrogianni,Christina %A Tsirigoti,Lydia %A Lambrinou,Christina P %A Godlewska,Magdalena %A Surwiłło,Agnieszka %A Gjelstad,Ingrid Merethe Fange %A Drevon,Christian A %A Manios,Yannis %A Traczyk,Iwona %A Martinez,J Alfredo %A Saris,Wim H M %A Daniel,Hannelore %A Lovegrove,Julie A %A Mathers,John C %A Gibney,Michael J %A Gibney,Eileen R %A Brennan,Lorraine %+ UCD Institute of Food and Health, University College Dublin, Belfield, Dublin,, Ireland, 353 1 716 ext 2811, lorraine.brennan@ucd.ie %K dietary feedback %K Web-based dietary assessment tool %K Food4Me %K dietary decision trees %K personalized nutrition %K human nutrition %D 2016 %7 30.06.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite numerous healthy eating campaigns, the prevalence of diets high in saturated fatty acids, sugar, and salt and low in fiber, fruit, and vegetables remains high. With more people than ever accessing the Internet, Web-based dietary assessment instruments have the potential to promote healthier dietary behaviors via personalized dietary advice. Objective: The objectives of this study were to develop a dietary feedback system for the delivery of consistent personalized dietary advice in a multicenter study and to examine the impact of automating the advice system. Methods: The development of the dietary feedback system included 4 components: (1) designing a system for categorizing nutritional intakes; (2) creating a method for prioritizing 3 nutrient-related goals for subsequent targeted dietary advice; (3) constructing decision tree algorithms linking data on nutritional intake to feedback messages; and (4) developing personal feedback reports. The system was used manually by researchers to provide personalized nutrition advice based on dietary assessment to 369 participants during the Food4Me randomized controlled trial, with an automated version developed on completion of the study. Results: Saturated fatty acid, salt, and dietary fiber were most frequently selected as nutrient-related goals across the 7 centers. Average agreement between the manual and automated systems, in selecting 3 nutrient-related goals for personalized dietary advice across the centers, was highest for nutrient-related goals 1 and 2 and lower for goal 3, averaging at 92%, 87%, and 63%, respectively. Complete agreement between the 2 systems for feedback advice message selection averaged at 87% across the centers. Conclusions: The dietary feedback system was used to deliver personalized dietary advice within a multi-country study. Overall, there was good agreement between the manual and automated feedback systems, giving promise to the use of automated systems for personalizing dietary advice. Trial Registration: Clinicaltrials.gov NCT01530139; https://clinicaltrials.gov/ct2/show/NCT01530139 (Archived by WebCite at http://www.webcitation.org/6ht5Dgj8I) %M 27363307 %R 10.2196/jmir.5620 %U http://www.jmir.org/2016/6/e150/ %U https://doi.org/10.2196/jmir.5620 %U http://www.ncbi.nlm.nih.gov/pubmed/27363307 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 6 %P e181 %T Evaluation Methods for Assessing Users’ Psychological Experiences of Web-Based Psychosocial Interventions: A Systematic Review %A Feather,Jacqueline Susan %A Howson,Moira %A Ritchie,Linda %A Carter,Philip D %A Parry,David Tudor %A Koziol-McLain,Jane %+ Centre for Interdisciplinary Trauma Research, Department of Psychology, Auckland University of Technology, A-12, Private Bag 92006, Auckland, 1142, New Zealand, 64 99219999 ext 7693, jackie.feather@aut.ac.nz %K eHealth %K medical informatics applications %K web browser %K Web-based %K usability %K computer systems %K psychology, clinical %K usability testing %K eHealth evaluation %D 2016 %7 30.06.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: The use of Web-based interventions to deliver mental health and behavior change programs is increasingly popular. They are cost-effective, accessible, and generally effective. Often these interventions concern psychologically sensitive and challenging issues, such as depression or anxiety. The process by which a person receives and experiences therapy is important to understanding therapeutic process and outcomes. While the experience of the patient or client in traditional face-to-face therapy has been evaluated in a number of ways, there appeared to be a gap in the evaluation of patient experiences of therapeutic interventions delivered online. Evaluation of Web-based artifacts has focused either on evaluation of experience from a computer Web-design perspective through usability testing or on evaluation of treatment effectiveness. Neither of these methods focuses on the psychological experience of the person while engaged in the therapeutic process. Objective: This study aimed to investigate what methods, if any, have been used to evaluate the in situ psychological experience of users of Web-based self-help psychosocial interventions. Methods: A systematic literature review was undertaken of interdisciplinary databases with a focus on health and computer sciences. Studies that met a predetermined search protocol were included. Results: Among 21 studies identified that examined psychological experience of the user, only 1 study collected user experience in situ. The most common method of understanding users’ experience was through semistructured interviews conducted posttreatment or questionnaires administrated at the end of an intervention session. The questionnaires were usually based on standardized tools used to assess user experience with traditional face-to-face treatment. Conclusions: There is a lack of methods specified in the literature to evaluate the interface between Web-based mental health or behavior change artifacts and users. Main limitations in the research were the nascency of the topic and cross-disciplinary nature of the field. There is a need to develop and deliver methods of understanding users’ psychological experiences while using an intervention. %M 27363519 %R 10.2196/jmir.5455 %U http://www.jmir.org/2016/6/e181/ %U https://doi.org/10.2196/jmir.5455 %U http://www.ncbi.nlm.nih.gov/pubmed/27363519 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 6 %P e146 %T Adherence to Internet-Based Mobile-Supported Stress Management: A Pooled Analysis of Individual Participant Data From Three Randomized Controlled Trials %A Zarski,Anna-Carlotta %A Lehr,Dirk %A Berking,Matthias %A Riper,Heleen %A Cuijpers,Pim %A Ebert,David Daniel %+ Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nuremberg, Nägelsbachstr. 25a, Erlangen, 91052, Germany, 49 9131 85 67570, Anna-Carlotta.Zarski@fau.de %K guidance %K treatment adherence %K predictors %K Internet intervention %K work-related stress %K stress management %D 2016 %7 29.06.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Nonadherence to treatment is a prevalent issue in Internet interventions. Guidance from health care professionals has been found to increase treatment adherence rates in Internet interventions for a range of physical and mental disorders. Evaluating different guidance formats of varying intensity is important, particularly with respect to improvement of effectiveness and cost-effectiveness. Identifying predictors of nonadherence allows for the opportunity to better adapt Internet interventions to the needs of participants especially at risk for discontinuing treatment. Objective: The goal of this study was to investigate the influence of different guidance formats (content-focused guidance, adherence-focused guidance, and administrative guidance) on adherence and to identify predictors of nonadherence in an Internet-based mobile-supported stress management intervention (ie, GET.ON Stress) for employees. Methods: The data from the groups who received the intervention were pooled from three randomized controlled trials (RCTs) that evaluated the efficacy of the same Internet-based mobile-supported stress management intervention (N=395). The RCTs only differed in terms of the guidance format (content-focused guidance vs waitlist control, adherence-focused guidance vs waitlist control, administrative guidance vs waitlist control). Adherence was defined by the number of completed treatment modules (0-7). An ANOVA was performed to compare the adherence rates from the different guidance formats. Multiple hierarchical linear regression analysis was conducted to evaluate predictors of nonadherence, which included gender, age, education, symptom-related factors, and hope for improvement. Results: In all, 70.5% (93/132) of the content-focused guidance sample, 68.9% (91/132) of the adherence-focused guidance sample, and 42.0% (55/131) of the participants in the administrative guidance sample completed all treatment modules. Guidance had a significant effect on treatment adherence (F2,392=11.64, P<.001; ω2=.05). Participants in the content-focused guidance (mean 5.70, SD 2.32) and adherence-focused guidance samples (mean 5.58, SD 2.33) completed significantly more modules than participants in the administrative guidance sample (mean 4.36, SD 2.78; t223=4.53, P<.001; r=.29). Content-focused guidance was not significantly associated with higher adherence compared to adherence-focused guidance (t262=0.42, P=.67; r=.03). The effect size of r=.03 (95% CI –0.09 to 0.15) did not pass the equivalence margin of r=.20 and the upper bound of the 95% CI lay below the predefined margin, indicating equivalence between adherence-focused guidance and content-focused guidance. Beyond the influence of guidance, none of the predictors significantly predicted nonadherence. Conclusions: Guidance has been shown to be an influential factor in promoting adherence to an Internet-based mobile-supported stress management intervention. Adherence-focused guidance, which included email reminders and feedback on demand, was equivalent to content-focused guidance with regular feedback while requiring only approximately a quarter of the coaching resources. This could be a promising discovery in terms of cost-effectiveness. However, even after considering guidance, sociodemographic, and symptom-related characteristics, most interindividual differences in nonadherence remain unexplained. Clinical Trial: DRKS00004749; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL _ID=DRKS00004749 (Archived by WebCite at http://www.webcitation.org/6QiDk9Zn8); DRKS00005112; http://drks-neu.uniklinik-freiburg. de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005112 (Archived by WebCite at http://www.webcitation.org/6QiDysvev); DRKS00005384; http://drks-neu.uniklinik-freiburg.de/ drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005384 (Archived by WebCite at http://www.webcitation.org/6QiE0xcpE) %M 27357528 %R 10.2196/jmir.4493 %U http://www.jmir.org/2016/6/e146/ %U https://doi.org/10.2196/jmir.4493 %U http://www.ncbi.nlm.nih.gov/pubmed/27357528 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 6 %P e183 %T Photoaging Mobile Apps in School-Based Tobacco Prevention: The Mirroring Approach %A Brinker,Titus Josef %A Seeger,Werner %A Buslaff,Fabian %+ Universities of Giessen and Marburg Lung Center, Member of the German Center for Lung Research, Justus-Liebig-University of Giessen, Klinikstr. 33, Giessen, 35392, Germany, 49 15175084347, titus.brinker@gmail.com %K tobacco %K smoking %K adolescents %K photoaging %K apps %K secondary schools %K adolescent smoking %K tobacco prevention %K smoking prevention %K smoking cessation %D 2016 %7 28.06.2016 %9 Short Paper %J J Med Internet Res %G English %X Background: Most smokers start smoking during their early adolescence, often with the idea that smoking is glamorous. Adolescent smoking can best be prevented through health education at schools. Interventions that take advantage of the broad availability of mobile phones as well as adolescents’ interest in their appearance may be a novel way to improve prevention. Objective: In this first pilot study, we aimed to use mobile phone technology in accordance with the theory of planned behavior to improve school-based tobacco prevention. Methods: We used a free photoaging mobile phone app (“Smokerface”) in three German secondary schools via a novel method called mirroring. The students’ altered three-dimensional selfies on mobile phones or tablets were “mirrored” via a projector in front of their whole grade. Using an anonymous questionnaire, we then measured on a 5-point Likert scale the perceptions of the intervention among 125 students of both genders (average age 12.75 years). Results: A majority of the students perceived the intervention as fun (77/125, 61.6%), claimed that the intervention motivated them not to smoke (79/125, 63.2%), and stated that they learned new benefits of non-smoking (81/125, 64.8%). Only a minority of students disagreed or fully disagreed that they learned new benefits of non-smoking (16/125, 12.8%) or that they were themselves motivated not to smoke (18/125, 14.4%). Conclusions: We have presented a novel method to integrate photoaging in school-based tobacco prevention that affects student peer groups and considers the predictors of smoking in accordance with the theory of planned behavior. %M 27352819 %R 10.2196/jmir.6016 %U http://www.jmir.org/2016/6/e183/ %U https://doi.org/10.2196/jmir.6016 %U http://www.ncbi.nlm.nih.gov/pubmed/27352819 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 6 %P e176 %T How a Fully Automated eHealth Program Simulates Three Therapeutic Processes: A Case Study %A Holter,Marianne T. S %A Johansen,Ayna %A Brendryen,Håvar %+ The Norwegian Centre for Addiction Research, Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Postboks 1039 Blindern, Oslo, 0315, Norway, 47 93 62 30 61, m.t.s.holter@medisin.uio.no %K Internet %K eHealth %K telemedicine %K behavior therapy %K motivational interviewing %K working alliance %K intervention mapping %K smoking cessation %K cell phones %K text messaging %D 2016 %7 28.06.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: eHealth programs may be better understood by breaking down the components of one particular program and discussing its potential for interactivity and tailoring in regard to concepts from face-to-face counseling. In the search for the efficacious elements within eHealth programs, it is important to understand how a program using lapse management may simultaneously support working alliance, internalization of motivation, and behavior maintenance. These processes have been applied to fully automated eHealth programs individually. However, given their significance in face-to-face counseling, it may be important to simulate the processes simultaneously in interactive, tailored programs. Objective: We propose a theoretical model for how fully automated behavior change eHealth programs may be more effective by simulating a therapist’s support of a working alliance, internalization of motivation, and managing lapses. Methods: We show how the model is derived from theory and its application to Endre, a fully automated smoking cessation program that engages the user in several “counseling sessions” about quitting. A descriptive case study based on tools from the intervention mapping protocol shows how each therapeutic process is simulated. Results: The program supports the user’s working alliance through alliance factors, the nonembodied relational agent Endre and computerized motivational interviewing. Computerized motivational interviewing also supports internalized motivation to quit, whereas a lapse management component responds to lapses. The description operationalizes working alliance, internalization of motivation, and managing lapses, in terms of eHealth support of smoking cessation. Conclusions: A program may simulate working alliance, internalization of motivation, and lapse management through interactivity and individual tailoring, potentially making fully automated eHealth behavior change programs more effective. %M 27354373 %R 10.2196/jmir.5415 %U http://www.jmir.org/2016/6/e176/ %U https://doi.org/10.2196/jmir.5415 %U http://www.ncbi.nlm.nih.gov/pubmed/27354373 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 6 %P e174 %T Decreased Body Mass Index in Schoolchildren After Yearlong Information Sessions With Parents Reinforced With Web and Mobile Phone Resources: Community Trial %A Vilchis-Gil,Jenny %A Klünder-Klünder,Miguel %A Duque,Ximena %A Flores-Huerta,Samuel %+ Hospital Infantil de México Federico Gómez, Ministry of Health (SSA), Community Health Research Department, Dr. Márquez No. 162, Mexico City, 06720, Mexico, 52 55 5228 9917 ext 4510, floreshuertamd@gmail.com %K obesity %K child %K early intervention (education) %K prevention %K Internet %K mobile phone %D 2016 %7 24.06.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: The obesity pandemic has now reached children, and households should change their lifestyles to prevent it. Objective: The objective was to assess the effect of a comprehensive intervention on body mass index z-score (BMIZ) in schoolchildren. Methods: A yearlong study was conducted at 4 elementary schools in Mexico City. Intervention group (IG) and control group (CG) were split equally between governmental and private schools. Three educational in-person parents and children sessions were held at 2-month intervals to promote healthy eating habits and exercise. To reinforce the information, a website provided extensive discussion on a new topic every 2 weeks, including school snack menus and tools to calculate body mass index in children and adults. Text messages were sent to parents’ mobile phones reinforcing the information provided. The IG contained 226 children and CG 181 children. We measured their weight and height and calculated BMIZ at 0, 6, and 12 months. Results: The CG children showed a change of +0.06 (95% CI 0.01, 0.11) and +0.05 (95% CI 0.01, 0.10) in their BMIZ at 6 and 12 months, respectively. The BMIZ of IG children decreased by -0.13 (95% CI -0.19 to -0.06) and -0.10 (95% CI -0.16 to -0.03), respectively, and the effect was greater in children with obesity. Conclusions: The comprehensive intervention tested had beneficial effects, preserved the BMIZ of normal weight children, and reduced the BMIZ of children with obesity. %M 27342650 %R 10.2196/jmir.5584 %U http://www.jmir.org/2016/6/e174/ %U https://doi.org/10.2196/jmir.5584 %U http://www.ncbi.nlm.nih.gov/pubmed/27342650 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 6 %P e164 %T Benefits of Diabetes Self-Management for Health Plan Members: A 6-Month Translation Study %A Lorig,Kate %A Ritter,Philip L %A Turner,Ralph M %A English,Kathleen %A Laurent,Diana D %A Greenberg,Jay %+ Stanford School of Medicine, Stanford University, 1000 Welch Rd., Suite 204, Palo Alto, CA, 94304, United States, 1 650 725 2873, philr@stanford.edu %K patient education %K self-management %K type 2 diabetes %K translation and dissemination %D 2016 %7 24.06.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Diabetes self-management education has been shown to be effective in controlled trials. However, few programs that meet American Association of Diabetes Educators standards have been translated into widespread practice. Objective: This study examined the translation of the evidence-based Better Choices, Better Health-Diabetes program in both Internet and face-to-face versions. Methods: We administered the Internet program nationally in the United States (n=1010). We conducted face-to-face workshops in Atlanta, Georgia; Indianapolis, Indiana; and St. Louis, Missouri (n=232). Self-report questionnaires collected health indicator, health behavior, and health care utilization measures. Questionnaires were administered on the Web or by mail. We determined hemoglobin A1c (HbA1c) from blood samples collected via mailed kits. Paired t tests determined whether changes between baseline and 6 months differed significantly from no change. Subgroup analyses determined whether participants with specific conditions benefited (high HbA1c, depression, hypoglycemia, nonadherence to medication taking, and no aerobic exercise). We calculated the percentage of participants with improvements of at least 0.4 effect size in at least one of the 5 above measures. Results: Of the 1242 participants, 884 provided 6-month follow-up questionnaires. There were statistically significant improvements in 6 of 7 health indicators (including HbA1c) and in 7 of 7 behaviors. For each of the 5 conditions, there were significant improvements among those with the condition (effect sizes 0.59–1.1). A total of 662 (75.0%) of study participants improved at least 0.4 effect size in at least one criterion, and 327 (37.1%) improved in 2 or more. Conclusions: The Diabetes Self-Management Program, offered in two modes, was successfully disseminated to a heterogeneous national population of members of either insured or administered health plans. Participants had small but significant benefits in multiple measures. The program appears effective in improving diabetes management. %M 27342265 %R 10.2196/jmir.5568 %U http://www.jmir.org/2016/6/e164/ %U https://doi.org/10.2196/jmir.5568 %U http://www.ncbi.nlm.nih.gov/pubmed/27342265 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 6 %P e169 %T If You Build It, Will They Come? Patterns of Internet-Based and Face-To-Face Participation in a Parenting Program for Military Families %A Doty,Jennifer L %A Rudi,Jessie H %A Pinna,Keri L M %A Hanson,Sheila K %A Gewirtz,Abigail H %+ University of Minnesota, Family Social Science, Room 294 McNH, 1985 Buford Ave, St. Paul, MN, 55108, United States, 1 612 624 1475, agewirtz@umn.edu %K parenting %K evidence-based practice %K military %K prevention %K Internet %K interactive media %D 2016 %7 22.06.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Some evidence suggests parents are drawn to media-based interventions over face-to-face interventions, but little is known about the factors associated with parents’ use of Internet-based or Internet-enhanced programs, especially among military families. Research is needed to understand characteristics of parents who may be most likely to use online components or attend face-to-face meetings in order to ensure maximum engagement. Objective: In this study, we examined characteristics that predict various patterns of Internet use and face-to-face attendance in a parenting program designed for military families. Methods: An ecological framework guided analysis of differences in patterns of Internet-based use and face-to-face attendance by parents’ demographic characteristics (gender, education, employment, and child age), incentives offered, and number of months the parent was deployed. We reported differences in the total number of online components completed over the 14 modules, total number of face-to-face sessions attended, and the use of different types of online components accessed (videos, downloadable handouts, mindfulness exercises, knowledge checks, and downloadable summaries). Then, we computed multinomial logistic regression accounting for nestedness (parents within families) to examine associations between demographic, programmatic, and military-related characteristics and patterns of engagement (use of online components and attendance at face-to-face sessions). Results: Just over half (52.2%, 193/370) of the participants used the online components at least once, and the majority of participants (73.2%, 271/370) attended at least 1 face-to-face session. An examination of different patterns of participation revealed that compared with those who participated primarily in face-to-face sessions, parents who participated online but had little face-to-face participation were more likely to have received incentives than those who did not (95% CI 1.9-129.7). Among participants who had been deployed, those who had earned a 4-year degree (95% CI 1.0-2.2) and those who had been offered incentives to participate online (95% CI 2.1-58.6) were more likely to be highly engaged in online components and attend face-to-face compared with those who attended primarily face-to-face. However, those with a high number of months of deployment (95% CI 0.6-1.0) were less likely to be in the pattern of highly engaged in online components and face-to-face attendance. Compared with those who participated primarily face-to-face, deployed mothers were about 4 times more likely to engage in moderate online use with face-to-face attendance than deployed fathers (95% CI 1.21-11.83) and participate primarily online (95% CI 0.77-25.20). Conclusions: Results imply that parents may be drawn to different delivery options of a parenting program (online components vs face-to-face sessions) depending on their education level, incentives to engage in online components, and their military-related experience. Results suggest potential directions for tailoring Internet-based interventions. %M 27334833 %R 10.2196/jmir.4445 %U http://www.jmir.org/2016/6/e169/ %U https://doi.org/10.2196/jmir.4445 %U http://www.ncbi.nlm.nih.gov/pubmed/27334833 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 6 %P e159 %T Web-Based Fully Automated Self-Help With Different Levels of Therapist Support for Individuals With Eating Disorder Symptoms: A Randomized Controlled Trial %A Aardoom,Jiska J %A Dingemans,Alexandra E %A Spinhoven,Philip %A van Ginkel,Joost R %A de Rooij,Mark %A van Furth,Eric F %+ Rivierduinen Eating Disorders Ursula, PO BOX 405, Leiden, 2300 AK, Netherlands, 31 718903009, j.aardoom@rivierduinen.nl %K ehealth %K eating disorders %K Internet-based %K therapist support %K self-monitoring %K self-help %D 2016 %7 17.06.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite the disabling nature of eating disorders (EDs), many individuals with ED symptoms do not receive appropriate mental health care. Internet-based interventions have potential to reduce the unmet needs by providing easily accessible health care services. Objective: This study aimed to investigate the effectiveness of an Internet-based intervention for individuals with ED symptoms, called “Featback.” In addition, the added value of different intensities of therapist support was investigated. Methods: Participants (N=354) were aged 16 years or older with self-reported ED symptoms, including symptoms of anorexia nervosa, bulimia nervosa, and binge eating disorder. Participants were recruited via the website of Featback and the website of a Dutch pro-recovery–focused e-community for young women with ED problems. Participants were randomized to: (1) Featback, consisting of psychoeducation and a fully automated self-monitoring and feedback system, (2) Featback supplemented with low-intensity (weekly) digital therapist support, (3) Featback supplemented with high-intensity (3 times a week) digital therapist support, and (4) a waiting list control condition. Internet-administered self-report questionnaires were completed at baseline, post-intervention (ie, 8 weeks after baseline), and at 3- and 6-month follow-up. The primary outcome measure was ED psychopathology. Secondary outcome measures were symptoms of depression and anxiety, perseverative thinking, and ED-related quality of life. Statistical analyses were conducted according to an intent-to-treat approach using linear mixed models. Results: The 3 Featback conditions were superior to a waiting list in reducing bulimic psychopathology (d=−0.16, 95% confidence interval (CI)=−0.31 to −0.01), symptoms of depression and anxiety (d=−0.28, 95% CI=−0.45 to −0.11), and perseverative thinking (d=−0.28, 95% CI=−0.45 to −0.11). No added value of therapist support was found in terms of symptom reduction although participants who received therapist support were significantly more satisfied with the intervention than those who did not receive supplemental therapist support. No significant differences between the Featback conditions supplemented with low- and high-intensity therapist support were found regarding the effectiveness and satisfaction with the intervention. Conclusions: The fully automated Internet-based self-monitoring and feedback intervention Featback was effective in reducing ED and comorbid psychopathology. Supplemental therapist support enhanced satisfaction with the intervention but did not increase its effectiveness. Automated interventions such as Featback can provide widely disseminable and easily accessible care. Such interventions could be incorporated within a stepped-care approach in the treatment of EDs and help to bridge the gap between mental disorders and mental health care services. Trial Registration: Netherlands Trial Registry: NTR3646; http://www.trialregister.nl/trialreg/admin/ rctview.asp?TC=3646 (Archived by WebCite at http://www.webcitation.org/6fgHTGKHE) %M 27317358 %R 10.2196/jmir.5709 %U http://www.jmir.org/2016/6/e159/ %U https://doi.org/10.2196/jmir.5709 %U http://www.ncbi.nlm.nih.gov/pubmed/27317358 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 6 %P e171 %T Changing Behavioral Lifestyle Risk Factors Related to Cognitive Decline in Later Life Using a Self-Motivated eHealth Intervention in Dutch Adults %A Aalbers,Teun %A Qin,Li %A Baars,Maria AE %A de Lange,Annet %A Kessels,Roy PC %A Olde Rikkert,Marcel GM %+ Radboud University Medical Center, Department of Geriatric Medicine, Reinier Postlaan 4, Nijmegen, 6500 HB, Netherlands, 31 243619807, teun.aalbers@radboudumc.nl %K lifestyle %K risk reduction behavior %K cognition %K video games %K telemedicine %D 2016 %7 17.06.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Our labor force is aging, but aged workers are not yet coached on how to stay cognitively fit for the job. Objective: In this study, we tested whether a self-motivated, complex eHealth intervention could improve multiple health-related behaviors that are associated with cognitive aging among working Dutch adults. Methods: This quasi-experimental prospective study with a pre-post design was conducted with employees of Dutch medium to large companies. All employees with Internet access, a good understanding of the Dutch language, and who provided digital informed consent were eligible to participate. In total, 2972 participants (2110/2972, 71.11% females) with a mean (standard deviation, SD) age of 51.8 (SD 12.9) years were recruited; 2305 became active users of the intervention, and 173 completed the 1-year follow-up. This self-motivated eHealth lifestyle intervention stimulates participants to set personally relevant, monthly health behavior change goals using Goal Attainment Scaling and to realize these goals by implementing behavior change techniques grounded in behavior change theory. The primary outcomes were the goal-setting success rate and the change in overall lifestyle score from baseline to the 1-year follow-up; the score was based on physical activity, diet, smoking, alcohol, sleep, and stress scores. The secondary outcomes were the changes in body weight, body mass index, specific lifestyle characteristics, and website usage. Results: A total of 1212 participants set 2620 behavior change goals; 392 participants assessed 1089 (1089/2288, 47.59%) goals and successfully achieved 422 (422/1089, 38.75%) of these goals. Among the goal-setting participants in follow-up, this led to a +0.81-point improvement (95% CI 0.49-1.13, P<.001) in overall lifestyle (d=0.32) and weight loss of 0.62 kg (95% CI −1.16 to −0.07, P=.03). These participants also showed significant improvement in 8 out of 11 specific lifestyle components. Conclusions: Among an adult Dutch population, this eHealth intervention resulted in lifestyle changes in behavioral risk factors associated with cognitive decline, and these improvements lasted over the period of 1 year. Given the general aging of our workforce, this eHealth intervention opens new avenues for the widespread use of cost-effective self-motivated prevention programs aimed at prevention of early-stage cognitive decline and more self-management of their risk factors. Trial Registration: Nederlands Trial Register: NTR4144; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4144 (Archived by WebCite at http://www.webcitation.org/6cZzwZSg3). %M 27317506 %R 10.2196/jmir.5269 %U http://www.jmir.org/2016/6/e171/ %U https://doi.org/10.2196/jmir.5269 %U http://www.ncbi.nlm.nih.gov/pubmed/27317506 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e127 %T Using Behavioral Intervention Technologies to Help Low-Income and Latino Smokers Quit: Protocol of a Randomized Controlled Trial %A Muñoz,Ricardo F %A Bunge,Eduardo L %A Barrera,Alinne Z %A Wickham,Robert E %A Lee,Jessica %+ Palo Alto University, 1791 Arastradero, Palo Alto, CA,, United States, 1 800 818 6136, rmunoz@paloaltou.edu %K smoking cessation %K Web app %K human-centered design %K recruitment %K dissemination %D 2016 %7 14.06.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: The Institute for International Internet Interventions for Health at Palo Alto University proposes to develop digital tools specifically to help low-income English- and Spanish-speaking smokers to quit. Individuals from lower-income countries and those with lower social status quit at lower rates than those from high-income countries and those with higher social status. Objective: We plan to launch a project designed to test whether a mobile-based digital intervention designed with systematic input from low-income English- and Spanish-speaking smokers from a public-sector health care system can significantly improve its acceptability, utilization, and effectiveness. Methods: Using human-centered development methods, we will involve low-income patients in the design of a Web app/text messaging tool. We will also use their input to improve our recruitment and dissemination strategies. We will iteratively develop versions of the digital interventions informed by our human-centered approach. The project involves three specific aims: (1) human-centered development of an English/Spanish smoking cessation web app, (2) improvement of dissemination strategies, and (3) evaluation of resulting smoking cessation web app. We will develop iterative versions of a digital smoking cessation tool that is highly responsive to the needs and preferences of the users. Input from participants will identify effective ways of reaching and encouraging low-income English- and Spanish-speaking smokers to use the digital smoking cessation interventions to be developed. This information will support ongoing dissemination and implementation efforts beyond the grant period. We will evaluate the effectiveness of the successive versions of the resulting stop smoking Web app by an online randomized controlled trial. Increased effectiveness will be defined as increased utilization of the Web app and higher abstinence rates than those obtained by a baseline usual care Web app. Results: Recruitment will begin January 2016, the study is intended to be completed by summer 2018, and the results should be available by fall 2019. Conclusions: This study will provide useful knowledge in developing, testing, and disseminating mobile-based interventions for low-income smokers. ClinicalTrial: ClinicalTrials.gov NCT02666482; https://clinicaltrials.gov/ct2/show/NCT02666482 (Archived by WebCite at http://www.webcitation.org/6gtcwaT28) %M 27302623 %R 10.2196/resprot.5355 %U http://www.researchprotocols.org/2016/3/e189/ %U https://doi.org/10.2196/resprot.5355 %U http://www.ncbi.nlm.nih.gov/pubmed/27302623 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 6 %P e133 %T A Technology-Mediated Behavioral Weight Gain Prevention Intervention for College Students: Controlled, Quasi-Experimental Study %A West,Delia Smith %A Monroe,Courtney M %A Turner-McGrievy,Gabrielle %A Sundstrom,Beth %A Larsen,Chelsea %A Magradey,Karen %A Wilcox,Sara %A Brandt,Heather M %+ Arnold School of Public Health, University of South Carolina, 915 Greene St, Discovery Building I, Suite 403, Columbia, SC, 29802, United States, 1 803 777 8826, westds@mailbox.sc.edu %K weight gain prevention %K college students %K social media %K wearables %K behavior change %D 2016 %7 13.06.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Both men and women are vulnerable to weight gain during the college years, and this phenomenon is linked to an increased risk of several chronic diseases and mortality. Technology represents an attractive medium for the delivery of weight control interventions focused on college students, given its reach and appeal among this population. However, few technology-mediated weight gain prevention interventions have been evaluated for college students. Objective: This study examined a new technology-based, social media-facilitated weight gain prevention intervention for college students. Methods: Undergraduates (n =58) in two sections of a public university course were allocated to either a behavioral weight gain prevention intervention (Healthy Weight, HW; N=29) or a human papillomavirus (HPV) vaccination awareness intervention (control; N=29). All students were enrolled, regardless of initial body weight or expressed interest in weight management. The interventions delivered 8 lessons via electronic newsletters and Facebook postings over 9 weeks, which were designed to foster social support and introduce relevant educational content. The HW intervention targeted behavioral strategies to prevent weight gain and provided participants with a Wi-Fi-enabled scale and an electronic physical activity tracker to facilitate weight regulation. A repeated-measures analysis of variance was conducted to examine within- and between-group differences in measures of self-reported weight control practices and objectively measured weight. Use of each intervention medium and device was objectively tracked, and intervention satisfaction measures were obtained. Results: Students remained weight stable (HW: −0.48+1.9 kg; control: −0.45+1.4 kg), with no significant difference between groups over 9 weeks (P =.94). However, HW students reported a significantly greater increase in the number of appropriate weight control strategies than did controls (2.1+4.5 vs −1.1+3.4, respectively; P =.003) and there was no increase in inappropriate weight control behaviors (P =.11). More than 90% of students in the HW arm opened the electronic newsletters each week, and the average number of Facebook interactions (comments and likes) per student each week was 3.3+1.4. Each self-monitoring device was initialized by 90% of HW students. On average, they used their physical activity tracker for 23.7+15.2 days and their Wi-Fi scale for 14.1+13.1 days over the 9 weeks. HW students rated the intervention favorably. Conclusions: The short-term effect of this technology-based weight gain prevention intervention for college students is promising and merits evaluation over a longer duration to determine whether engagement and behavioral improvements positively affect weight outcomes and can be maintained. %M 27296086 %R 10.2196/jmir.5474 %U http://www.jmir.org/2016/6/e133/ %U https://doi.org/10.2196/jmir.5474 %U http://www.ncbi.nlm.nih.gov/pubmed/27296086 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 6 %P e122 %T A Web-Based and Mobile Health Social Support Intervention to Promote Adherence to Inhaled Asthma Medications: Randomized Controlled Trial %A Koufopoulos,Justin T %A Conner,Mark T %A Gardner,Peter H %A Kellar,Ian %+ School of Psychology, Faculty of Medicine and Health, University of Leeds, Lifton Place, Leeds, LS2 9JT, United Kingdom, 44 (0)1133437242, i.kellar@leeds.ac.uk %K Internet %K telemedicine %K social support %K asthma %K adherence %K attrition %K engagement %K randomized controlled trial %K online community %K social health network %D 2016 %7 13.06.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Online communities hold great potential as interventions for health, particularly for the management of chronic illness. The social support that online communities can provide has been associated with positive treatment outcomes, including medication adherence. There are few studies that have attempted to assess whether membership of an online community improves health outcomes using rigorous designs. Objective: Our objective was to conduct a rigorous proof-of-concept randomized controlled trial of an online community intervention for improving adherence to asthma medicine. Methods: This 9-week intervention included a sample of asthmatic adults from the United Kingdom who were prescribed an inhaled corticosteroid preventer. Participants were recruited via email and randomized to either an “online community” or “no online community” (diary) condition. After each instance of preventer use, participants (N=216) were required to report the number of doses of medication taken in a short post. Those randomized to the online community condition (n=99) could read the posts of other community members, reply, and create their own posts. Participants randomized to the no online community condition (n=117) also posted their medication use, but could not read others’ posts. The main outcome measures were self-reported medication adherence at baseline and follow-up (9 weeks postbaseline) and an objective measure of adherence to the intervention (visits to site). Results: In all, 103 participants completed the study (intervention: 37.8%, 39/99; control: 62.2%, 64/117). MANCOVA of self-reported adherence to asthma preventer medicine at follow-up was not significantly different between conditions in either intention-to-treat (P=.92) or per-protocol (P=.68) analysis. Site use was generally higher in the control compared to intervention conditions. Conclusions: Joining an online community did not improve adherence to preventer medication for asthma patients. Without the encouragement of greater community support or more components to sustain engagement over time, the current findings do not support the use of an online community to improve adherence. ClinicalTrial: International Standard Randomized Controlled Trial Number (ISRCTN): 29399269; http://www.isrctn.com/ISRCTN29399269/29399269 (Archived by WebCite at http://www.webcitation.org/6fUbEuVoT) %M 27298211 %R 10.2196/jmir.4963 %U http://www.jmir.org/2016/6/e122/ %U https://doi.org/10.2196/jmir.4963 %U http://www.ncbi.nlm.nih.gov/pubmed/27298211 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 6 %P e135 %T Fundamentals for Future Mobile-Health (mHealth): A Systematic Review of Mobile Phone and Web-Based Text Messaging in Mental Health %A Berrouiguet,Sofian %A Baca-García,Enrique %A Brandt,Sara %A Walter,Michel %A Courtet,Philippe %+ Brest Medical University Hospital at Bohars, Adult Psychiatry, Hôpital de la Cavale Blanche-Bd Tanguy Prigent, Brest, 29200, France, 33 668204178, sofian.berrouiguet@gmail.com %K text messaging %K cell phones %K mental health %K Internet %K medical informatics %D 2016 %7 10.06.2016 %9 Review %J J Med Internet Res %G English %X Background: Mobile phone text messages (short message service, SMS) are used pervasively as a form of communication. Almost 100% of the population uses text messaging worldwide and this technology is being suggested as a promising tool in psychiatry. Text messages can be sent either from a classic mobile phone or a web-based application. Reviews are needed to better understand how text messaging can be used in mental health care and other fields of medicine. Objective: The objective of the study was to review the literature regarding the use of mobile phone text messaging in mental health care. Methods: We conducted a thorough literature review of studies involving text messaging in health care management. Searches included PubMed, PsycINFO, Cochrane, Scopus, Embase and Web of Science databases on May 25, 2015. Studies reporting the use of text messaging as a tool in managing patients with mental health disorders were included. Given the heterogeneity of studies, this review was summarized using a descriptive approach. Results: From 677 initial citations, 36 studies were included in the review. Text messaging was used in a wide range of mental health situations, notably substance abuse (31%), schizophrenia (22%), and affective disorders (17%). We identified four ways in which text messages were used: reminders (14%), information (17%), supportive messages (42%), and self-monitoring procedures (42%). Applications were sometimes combined. Conclusions: We report growing interest in text messaging since 2006. Text messages have been proposed as a health care tool in a wide spectrum of psychiatric disorders including substance abuse, schizophrenia, affective disorders, and suicide prevention. Most papers described pilot studies, while some randomized clinical trials (RCTs) were also reported. Overall, a positive attitude toward text messages was reported. RCTs reported improved treatment adherence and symptom surveillance. Other positive points included an increase in appointment attendance and in satisfaction with management and health care services. Insight into message content, preventative strategies, and innovative approaches derived from the mental health field may be applicable in other medical specialties. %M 27287668 %R 10.2196/jmir.5066 %U http://www.jmir.org/2016/6/e135/ %U https://doi.org/10.2196/jmir.5066 %U http://www.ncbi.nlm.nih.gov/pubmed/27287668 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 6 %P e147 %T A Mobile Phone App Intervention Targeting Fruit and Vegetable Consumption: The Efficacy of Textual and Auditory Tailored Health Information Tested in a Randomized Controlled Trial %A Elbert,Sarah Pietertje %A Dijkstra,Arie %A Oenema,Anke %+ Department of Social Psychology, University of Groningen, Grote Kruisstraat 2/1, Groningen, 9712 TS, Netherlands, 31 503638033, s.p.elbert@rug.nl %K mobile phone app %K health behavior %K fruit and vegetable intake %K persuasive communication %K communication modality %K audio %K intervention study %D 2016 %7 10.06.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Mobile phone apps are increasingly used to deliver health interventions, which provide the opportunity to present health information via different communication modes. However, scientific evidence regarding the effects of such health apps is scarce. Objective: In a randomized controlled trial, we tested the efficacy of a 6-month intervention delivered via a mobile phone app that communicated either textual or auditory tailored health information aimed at stimulating fruit and vegetable intake. A control condition in which no health information was given was added. Perceived own health and health literacy were included as moderators to assess for which groups the interventions could possibly lead to health behavior change. Methods: After downloading the mobile phone app, respondents were exposed monthly to either text-based or audio-based tailored health information and feedback over a period of 6 months via the mobile phone app. In addition, respondents in the control condition only completed the baseline and posttest measures. Within a community sample (online recruitment), self-reported fruit and vegetable intake at 6-month follow-up was our primary outcome measure. Results: In total, 146 respondents (ranging from 40 to 58 per condition) completed the study (attrition rate 55%). A significant main effect of condition was found on fruit intake (P=.049, partial η2=0.04). A higher fruit intake was found after exposure to the auditory information, especially in recipients with a poor perceived own health (P=.003, partial η2=0.08). In addition, health literacy moderated the effect of condition on vegetable intake 6 months later (P<.001, partial η2=.11). A higher vegetable intake was found for recipients with high health literacy after exposure to the textual or auditory intervention compared to the control condition (contrasts P=.07 and P=.004, respectively). In the case of relatively low health literacy, vegetable intake was the highest in the control condition (contrasts text control: P=.03; audio control: P=.04). Conclusions: This study provides evidence-based insight into the effects of a mobile health app. The app seems to have the potential to change fruit and vegetable intake up to 6 months later, at least for specific groups. We found different effects for fruit and vegetable intake, respectively, suggesting that different underlying psychological mechanisms are associated with these specific behaviors. Based on our results, it seems worthwhile to investigate additional ways to increase fruit and vegetable intake in recipients with low health literacy. ClinicalTrial: International Standard Randomized Controlled Trial Number (ISRCTN): 23466915; http://www.isrctn.com/ISRCTN23466915 (Archived by WebCite at http://www.webcitation.org/6hTtfSvaz) %M 27287823 %R 10.2196/jmir.5056 %U http://www.jmir.org/2016/6/e147/ %U https://doi.org/10.2196/jmir.5056 %U http://www.ncbi.nlm.nih.gov/pubmed/27287823 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 6 %P e155 %T Which Combinations of Techniques and Modes of Delivery in Internet-Based Interventions Effectively Change Health Behavior? A Meta-Analysis %A van Genugten,Lenneke %A Dusseldorp,Elise %A Webb,Thomas Llewelyn %A van Empelen,Pepijn %+ Institute of Psychology, Leiden University, PO Box 9555, Leiden, 2300 RB, Netherlands, 31 715278046, elise.dusseldorp@fsw.leidenuniv.nl %K meta-analysis %K prevention %K health behavior %K behavior change %K online %D 2016 %7 07.06.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Many online interventions designed to promote health behaviors combine multiple behavior change techniques (BCTs), adopt different modes of delivery (MoD) (eg, text messages), and range in how usable they are. Research is therefore needed to examine the impact of these features on the effectiveness of online interventions. Objective: This study applies Classification and Regression Trees (CART) analysis to meta-analytic data, in order to identify synergistic effects of BCTs, MoDs, and usability factors. Methods: We analyzed data from Webb et al. This review included effect sizes from 52 online interventions targeting a variety of health behaviors and coded the use of 40 BCTs and 11 MoDs. Our research also developed a taxonomy for coding the usability of interventions. Meta-CART analyses were performed using the BCTs and MoDs as predictors and using treatment success (ie, effect size) as the outcome. Results: Factors related to usability of the interventions influenced their efficacy. Specifically, subgroup analyses indicated that more efficient interventions (interventions that take little time to understand and use) are more likely to be effective than less efficient interventions. Meta-CART identified one synergistic effect: Interventions that included barrier identification/ problem solving and provided rewards for behavior change reported an average effect size that was smaller (ḡ=0.23, 95% CI 0.08-0.44) than interventions that used other combinations of techniques (ḡ=0.43, 95% CI 0.27-0.59). No synergistic effects were found for MoDs or for MoDs combined with BCTs. Conclusions: Interventions that take little time to understand and use were more effective than those that require more time. Few specific combinations of BCTs that contribute to the effectiveness of online interventions were found. Furthermore, no synergistic effects between BCTs and MoDs were found, even though MoDs had strong effects when analyzed univariately in the original study. %M 27268104 %R 10.2196/jmir.4218 %U http://www.jmir.org/2016/6/e155/ %U https://doi.org/10.2196/jmir.4218 %U http://www.ncbi.nlm.nih.gov/pubmed/27268104 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e115 %T A Web-Based Platform for Patients With Osteoarthritis of the Hip and Knee: A Pilot Study %A Dahlberg,Leif E %A Grahn,Daniel %A Dahlberg,Jakob E %A Thorstensson,Carina A %+ Orthopedics, Department of Clinical Sciences Lund, Skåne University Hospital, Lund University, Skåne University Hospital, Lund, SE-221 85, Sweden, 46 46171540, leif.dahlberg@med.lu.se %K osteoarthritis %K exercise therapy %K mobile apps %K digital therapeutics %D 2016 %7 03.06.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Chronic conditions are the leading cause of disability throughout the world and the most expensive problem facing the health care systems. One such chronic condition is osteoarthritis (OA), a frequent cause of major disability. Objective: To describe the effect on joint pain for the first users of a newly developed Web-based osteoarthritis self-managing program, Joint Academy, and to examine whether these patients would recommend other OA patients to use the program. Methods: Patients with clinically established knee or hip OA according to national and international guidelines were recruited from an online advertisement. A trained physiotherapist screened the eligible patients by scrutinizing their answers to a standardized questionnaire. The 6-week program consisted of eight 2- to 5-minute videos with lectures about OA, effects of physical activity, self-management, and coping strategies. In addition, exercises to improve lower extremity physical function were introduced in daily video activities. During the course of the program, communication between physiotherapist and patients was based on an asynchronous chat. After 6 weeks, patients were able to continue without support from the physiotherapist. Patients reported their current pain weekly by using a numeric rating scale (range 0-10; 0=no pain, 10=worst possible pain) as long as they were in the program. In addition, after 6 weeks patients answered the question “What is the probability that you would recommend Joint Academy to a friend?” Results: The eligible cohort consisted of 53 individuals (39 women; body mass index: mean 27, SD 5; age: mean 57, SD 14 years). With the continued use of the program, patients reported a constant change in pain score from mean 5.1 (SD 2.1) at baseline to mean 3.6 (SD 2.0) at week 12. Six patients participated for 30 weeks (mean 3.2, SD 2.1). Overall, the patients would highly recommend Joint Academy to other OA patients, suggesting that the platform may be useful for at least some in the vast OA population. Conclusions: Joint Academy, a Web-based platform for OA therapy, has the potential to successfully deliver individualized online treatment to many patients with OA that presently lack access to treatment. %M 27261271 %R 10.2196/resprot.5665 %U http://www.researchprotocols.org/2016/2/e115/ %U https://doi.org/10.2196/resprot.5665 %U http://www.ncbi.nlm.nih.gov/pubmed/27261271 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e103 %T An Internet-Based Intervention to Promote Alcohol-Related Attitudinal and Behavioral Change Among Adolescents: Protocol of a Cluster Randomized Controlled Trial %A Ip,Patrick %A Chan,Ko-Ling %A Chow,Chun-Bong %A Lam,Tai-Hing %A Ho,Sai-Yin %A Wong,Wilfred Hing-Sang %A Wong,Margaret Fung-Yee %+ The University of Hong Kong, Department of Paediatrics and Adolescent Medicine, 1/F, New Clinical Building, Queen Mary Hospital, Pokfulam, Hong Kong,, China (Hong Kong), 852 28198501, patricip@hku.hk %K Internet viral marketing %K attitude change %K behavioural change %K underage drinking %K risk behaviour %K Internet intervention %D 2016 %7 01.06.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Underage drinking is a prevalent risk behavior and common public health problem. Research shows that alcohol abuse not only affects the quality of life of drinkers themselves. The problems resulting from underage drinking pose substantial costs to society as well. The proposed study will address underage drinking with the use of an Internet campaign, which is a cost-effective way of tackling the problem. Objective: The aims of this study are to test the effectiveness of an online quiz competition in changing adolescents’ alcohol-related attitudes and behavior and to explore the feasibility of using Internet viral marketing to reach a significant number of adolescents. Methods: The study will constitute a cluster randomized controlled trial for 20 secondary schools (6720 Grade 7-9 students). Schools will be randomized to intervention or control arm with equal likelihood. Students in intervention schools will be invited to take part in the Internet campaign, whereas those in control schools will receive relevant promotional leaflets. Results: Alcohol-related attitude and behavior will be the primary outcome measures. The results of the proposed study will provide evidence on the efficacy of an Internet intervention in modifying adolescents’ attitudes and behavior and guide further investigation into the prevention of and intervention in such risk behaviors as underage drinking. The project was funded July 2015, enrollment started September 2015, and results are expected July 2017. Conclusions: With the Internet increasingly being recognized as a practical and cost-effective platform for health information delivery, the proposed Internet-based intervention is expected to be more effective in altering adolescents’ alcohol-related attitudes and behaviors than traditional health promotion. ClinicalTrial: ClinicalTrials.gov NCT02450344; https://clinicaltrials.gov/ct2/show/NCT02450344 (Archived by WebCite at http://www.webcitation.org/6heB2zMBD) %M 27252072 %R 10.2196/resprot.5001 %U http://www.researchprotocols.org/2016/2/e103/ %U https://doi.org/10.2196/resprot.5001 %U http://www.ncbi.nlm.nih.gov/pubmed/27252072 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 3 %N 2 %P e14 %T Finding Web-Based Anxiety Interventions on the World Wide Web: A Scoping Review %A Ashford,Miriam Thiel %A Olander,Ellinor K %A Ayers,Susan %+ Centre for Maternal and Child Health Research, School of Health Sciences, City University London, Northampton Square, London, EC1V 0HB, United Kingdom, 44 20 7040 ext 5775, miriam.ashford@city.ac.uk %K Anxiety %K mental health %K web-based interventions %K internet %K technology %K consumer %K access to health care %D 2016 %7 01.06.2016 %9 Review %J JMIR Ment Health %G English %X Background: One relatively new and increasingly popular approach of increasing access to treatment is Web-based intervention programs. The advantage of Web-based approaches is the accessibility, affordability, and anonymity of potentially evidence-based treatment. Despite much research evidence on the effectiveness of Web-based interventions for anxiety found in the literature, little is known about what is publically available for potential consumers on the Web. Objective: Our aim was to explore what a consumer searching the Web for Web-based intervention options for anxiety-related issues might find. The objectives were to identify currently publically available Web-based intervention programs for anxiety and to synthesize and review these in terms of (1) website characteristics such as credibility and accessibility; (2) intervention program characteristics such as intervention focus, design, and presentation modes; (3) therapeutic elements employed; and (4) published evidence of efficacy. Methods: Web keyword searches were carried out on three major search engines (Google, Bing, and Yahoo—UK platforms). For each search, the first 25 hyperlinks were screened for eligible programs. Included were programs that were designed for anxiety symptoms, currently publically accessible on the Web, had an online component, a structured treatment plan, and were available in English. Data were extracted for website characteristics, program characteristics, therapeutic characteristics, as well as empirical evidence. Programs were also evaluated using a 16-point rating tool. Results: The search resulted in 34 programs that were eligible for review. A wide variety of programs for anxiety, including specific anxiety disorders, and anxiety in combination with stress, depression, or anger were identified and based predominantly on cognitive behavioral therapy techniques. The majority of websites were rated as credible, secure, and free of advertisement. The majority required users to register and/or to pay a program access fee. Half of the programs offered some form of paid therapist or professional support. Programs varied in treatment length and number of modules and employed a variety of presentation modes. Relatively few programs had published research evidence of the intervention’s efficacy. Conclusions: This review represents a snapshot of available Web-based intervention programs for anxiety that could be found by consumers in March 2015. The consumer is confronted with a diversity of programs, which makes it difficult to identify an appropriate program. Limited reports and existence of empirical evidence for efficacy make it even more challenging to identify credible and reliable programs. This highlights the need for consistent guidelines and standards on developing, providing, and evaluating Web-based interventions and platforms with reliable up-to-date information for professionals and consumers about the characteristics, quality, and accessibility of Web-based interventions. %M 27251763 %R 10.2196/mental.5349 %U http://mental.jmir.org/2016/2/e14/ %U https://doi.org/10.2196/mental.5349 %U http://www.ncbi.nlm.nih.gov/pubmed/27251763 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 5 %P e96 %T The Effectiveness of a Web-Based Computer-Tailored Intervention on Workplace Sitting: A Randomized Controlled Trial %A De Cocker,Katrien %A De Bourdeaudhuij,Ilse %A Cardon,Greet %A Vandelanotte,Corneel %+ Department of Movement and Sports Sciences, Ghent University, Watersportlaan 2, Ghent, 9000, Belgium, 32 264 63 23, Katrien.DeCocker@ugent.be %K sedentary behavior %K computer tailoring %K employees %K activPAL %K sitting time %K randomized controlled trial %D 2016 %7 31.05.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Effective interventions to influence workplace sitting are needed, as office-based workers demonstrate high levels of continued sitting, and sitting too much is associated with adverse health effects. Therefore, we developed a theory-driven, Web-based, interactive, computer-tailored intervention aimed at reducing and interrupting sitting at work. Objective: The objective of our study was to investigate the effects of this intervention on objectively measured sitting time, standing time, and breaks from sitting, as well as self-reported context-specific sitting among Flemish employees in a field-based approach. Methods: Employees (n=213) participated in a 3-group randomized controlled trial that assessed outcomes at baseline, 1-month follow-up, and 3-month follow-up through self-reports. A subsample (n=122) were willing to wear an activity monitor (activPAL) from Monday to Friday. The tailored group received an automated Web-based, computer-tailored intervention including personalized feedback and tips on how to reduce or interrupt workplace sitting. The generic group received an automated Web-based generic advice with tips. The control group was a wait-list control condition, initially receiving no intervention. Intervention effects were tested with repeated-measures multivariate analysis of variance. Results: The tailored intervention was successful in decreasing self-reported total workday sitting (time × group: P<.001), sitting at work (time × group: P<.001), and leisure time sitting (time × group: P=.03), and in increasing objectively measured breaks at work (time × group: P=.07); this was not the case in the other conditions. The changes in self-reported total nonworkday sitting, sitting during transport, television viewing, and personal computer use, objectively measured total sitting time, and sitting and standing time at work did not differ between conditions. Conclusions: Our results point out the significance of computer tailoring for sedentary behavior and its potential use in public health promotion, as the effects of the tailored condition were superior to the generic and control conditions. Trial Registration: Clinicaltrials.gov NCT02672215; http://clinicaltrials.gov/ct2/show/NCT02672215 (Archived by WebCite at http://www.webcitation.org/6glPFBLWv) %M 27245789 %R 10.2196/jmir.5266 %U http://www.jmir.org/2016/5/e96/ %U https://doi.org/10.2196/jmir.5266 %U http://www.ncbi.nlm.nih.gov/pubmed/27245789 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 3 %N 2 %P e23 %T Mobile Phone and Web-based Cognitive Behavior Therapy for Depressive Symptoms and Mental Health Comorbidities in People Living With Diabetes: Results of a Feasibility Study %A Clarke,Janine %A Proudfoot,Judith %A Ma,Howard %+ Black Dog Institute, Hospital Road, Randwick, 2031, Australia, 61 2 9382 3767, janine.clarke@unsw.edu.au %K diabetes %K depression %K Internet interventions %K eHealth %K CBT %D 2016 %7 31.05.2016 %9 Original Paper %J JMIR Ment Health %G English %X Background: Depression is often comorbid with diabetes; however, undertreatment of depressive symptoms in people affected is common. Objective: We studied preliminary acceptability and effectiveness of a fully automated, mobile phone, and web-based public health intervention, myCompass, for reducing depressive symptoms and improving mental health comorbidities in people with diabetes. Methods: In this single-group feasibility study, 89 volunteers with type 1 (n=34) or type 2 (n=55) diabetes and at least mild depressive symptoms used myCompass for 7 weeks. Web-based measures of depressive and anxious symptoms, functional impairment, diabetes-specific variables, and user satisfaction were completed at baseline, postintervention, and 3-month follow-up. Results: Retention rates were 54% (n=48) at postintervention and 36% (n=32) at follow-up. Depressive symptoms were significantly improved at postintervention (P<.001; within-group effect size d=1.05), with gains persisting at follow-up. Mental health comorbidities, including anxiety (P<.001), functioning (P<.001), and diabetes-specific distress (P<.001), also showed significant and sustained improvement. Satisfaction with myCompass was high, with convenience and ease of program use, and relevance of program content rated positively by participants. Conclusions: The myCompass program shows promise as an acceptable and effective treatment for depression and comorbid mental health problems in people with diabetes. The program is broadly available, free to use, and may benefit patients with diabetes who do not access services and/or wish to manage their mental health themselves. Replication of these findings in a controlled study is warranted. %M 27245948 %R 10.2196/mental.5131 %U http://mental.jmir.org/2016/2/e23/ %U https://doi.org/10.2196/mental.5131 %U http://www.ncbi.nlm.nih.gov/pubmed/27245948 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 5 %P e121 %T Acceptability of Interventions Delivered Online and Through Mobile Phones for People Who Experience Severe Mental Health Problems: A Systematic Review %A Berry,Natalie %A Lobban,Fiona %A Emsley,Richard %A Bucci,Sandra %+ School of Psychological Sciences, Faculty of Medical and Human Sciences, University of Manchester, Room S42, Zochonis Building, Brunswick Street, Manchester, M13 9PL, United Kingdom, 44 16130 ext 60428, natalie.berry@manchester.ac.uk %K mHealth %K eHealth %K severe mental health %K psychosis %K bipolar disorder %K personality disorder %K severe mental health problems (SMI) %K acceptability %D 2016 %7 31.05.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Psychological interventions are recommended for people with severe mental health problems (SMI). However, barriers exist in the provision of these services and access is limited. Therefore, researchers are beginning to develop and deliver interventions online and via mobile phones. Previous research has indicated that interventions delivered in this format are acceptable for people with SMI. However, a comprehensive systematic review is needed to investigate the acceptability of online and mobile phone-delivered interventions for SMI in depth. Objective: This systematic review aimed to 1) identify the hypothetical acceptability (acceptability prior to or without the delivery of an intervention) and actual acceptability (acceptability where an intervention was delivered) of online and mobile phone-delivered interventions for SMI, 2) investigate the impact of factors such as demographic and clinical characteristics on acceptability, and 3) identify common participant views in qualitative studies that pinpoint factors influencing acceptability. Methods: We conducted a systematic search of the databases PubMed, Embase, PsycINFO, CINAHL, and Web of Science in April 2015, which yielded a total of 8017 search results, with 49 studies meeting the full inclusion criteria. Studies were included if they measured acceptability through participant views, module completion rates, or intervention use. Studies delivering interventions were included if the delivery method was online or via mobile phones. Results: The hypothetical acceptability of online and mobile phone-delivered interventions for SMI was relatively low, while actual acceptability tended to be high. Hypothetical acceptability was higher for interventions delivered via text messages than by emails. The majority of studies that assessed the impact of demographic characteristics on acceptability reported no significant relationships between the two. Additionally, actual acceptability was higher when participants were provided remote online support. Common qualitative factors relating to acceptability were safety and privacy concerns, the importance of an engaging and appealing delivery format, the inclusion of peer support, computer and mobile phone literacy, technical issues, and concerns about the impact of psychological state on intervention use. Conclusions: This systematic review provides an in-depth focus on the acceptability of online and mobile phone-delivered interventions for SMI and identified the need for further research in this area. Based on the results from this review, we recommend that researchers measure both hypothetical and actual acceptability to identify whether initial perceptions of online and mobile phone-delivered interventions change after access. In addition, more focus is needed on the potential impact of demographic and clinical characteristics on acceptability. The review also identified issues with module completion rates and intervention use as measures of acceptability. We therefore advise researchers to obtain qualitative reports of acceptability throughout each phase of intervention development and testing. Further implications and opportunities for future research are discussed. %M 27245693 %R 10.2196/jmir.5250 %U http://www.jmir.org/2016/5/e121/ %U https://doi.org/10.2196/jmir.5250 %U http://www.ncbi.nlm.nih.gov/pubmed/27245693 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 5 %P e134 %T The Electronic CardioMetabolic Program (eCMP) for Patients With Cardiometabolic Risk: A Randomized Controlled Trial %A Azar,Kristen MJ %A Koliwad,Suneil %A Poon,Tak %A Xiao,Lan %A Lv,Nan %A Griggs,Robert %A Ma,Jun %+ Sutter Health Research, Development and Dissemination, 2121 N. California Blvd, Walnut Creek, CA,, United States, 1 9252874052, azark@sutterhealth.org %K prevention %K lifestyle %K metabolic syndrome %K cardiovascular disease %K behavior change %K health technology %D 2016 %7 27.05.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Effective lifestyle interventions targeting high-risk adults that are both practical for use in ambulatory care settings and scalable at a population management level are needed. Objective: Our aim was to examine the potential effectiveness, feasibility, and acceptability of delivering an evidence-based Electronic Cardio-Metabolic Program (eCMP) for improving health-related quality of life, improving health behaviors, and reducing cardiometabolic risk factors in ambulatory care high-risk adults. Methods: We conducted a randomized, wait-list controlled trial with 74 adults aged ≥18 years recruited from a large multispecialty health care organization. Inclusion criteria were (1) BMI ≥35 kg/m2 and prediabetes, previous gestational diabetes and/or metabolic syndrome, or (2) BMI ≥30 kg/m2 and type 2 diabetes and/or cardiovascular disease. Participants had a mean age of 59.7 years (SD 11.2), BMI 37.1 kg/m2 (SD 5.4) and were 59.5% female, 82.4% white. Participants were randomized to participate in eCMP immediately (n=37) or 3 months later (n=37). eCMP is a 6-month program utilizing video conferencing, online tools, and pre-recorded didactic videos to deliver evidence-based curricula. Blinded outcome assessments were conducted at 3 and 6 months postbaseline. Data were collected and analyzed between 2014 and 2015. The primary outcome was health-related quality of life. Secondary outcomes included biometric cardiometabolic risk factors (eg, body weight), self-reported diet and physical activity, mental health status, retention, session attendance, and participant satisfaction. Results: Change in quality of life was not significant in both immediate and delayed participants. Both groups significantly lost weight and reduced waist circumference at 6 months, with some cardiometabolic factors trending accordingly. Significant reduction in self-reported anxiety and perceived stress was seen in the immediate intervention group at 6 months. Retention rate was 93% at 3 months and 86% at 6 months post-baseline. Overall eCMP attendance was high with 59.5-83.8% of immediate and delayed intervention participants attending 50% of the virtual stress management and behavioral lifestyle sessions and 37.8-62.2% attending at least 4 out of 7 in-person physical activity sessions. The intervention received high ratings for satisfaction. Conclusions: The technology-assisted eCMP is a feasible and well-accepted intervention and may significantly decrease cardiometabolic risk among high-risk individuals. Trial Registration: Clinicaltrials.gov NCT02246400; https://clinicaltrials.gov/ct2/show/NCT02246400 (Archived by WebCite at http://www.webcitation.org/6h6mWWokP) %M 27234480 %R 10.2196/jmir.5143 %U http://www.jmir.org/2016/5/e134/ %U https://doi.org/10.2196/jmir.5143 %U http://www.ncbi.nlm.nih.gov/pubmed/27234480 %0 Journal Article %@ 2291-9279 %I JMIR Publications Inc. %V 4 %N 1 %P e3 %T Crave-Out: A Distraction/Motivation Mobile Game to Assist in Smoking Cessation %A DeLaughter,Kathryn L %A Sadasivam,Rajani S %A Kamberi,Ariana %A English,Thomas M %A Seward,Greg L %A Chan,S Wayne %A Volkman,Julie E %A Amante,Daniel J %A Houston,Thomas K %+ CHOIR ENRM VAMC, 200 Springs Rd., Bedford, MA,, United States, 1 781 687 2559, kathryn.delaughter@va.gov %K smoking cessation %K Internet %K secondary prevention %K health behavior %D 2016 %7 26.05.2016 %9 Original Paper %J JMIR Serious Games %G English %X Background: Smoking is still the number one preventable cause of death. Cravings—an intense desire or longing for a cigarette—are a major contributor to quit attempt failure. New tools to help smokers’ manage their cravings are needed. Objective: To present a case study of the development process and testing of a distraction/motivation game (Crave-Out) to help manage cravings. Methods: We used a phased approach: in Phase 1 (alpha testing), we tested and refined the game concept, using a Web-based prototype. In Phase 2 (beta testing), we evaluated the distraction/motivation potential of the mobile game prototype, using a prepost design. After varying duration of abstinence, smokers completed the Questionnaire of Smoking Urge-Brief (QSU-Brief) measurement before and after playing Crave-Out. Paired t tests were used to compare pregame and postgame QSU-Brief levels. To test dissemination potential, we released the game on the Apple iTunes App Store and tracked downloads between December 22, 2011, and May 5, 2014. Results: Our concept refinement resulted in a multilevel, pattern memory challenge game, with each level increasing in difficulty. Smokers could play the game as long as they wanted. At the end of each level, smokers were provided clear goals for the next level and rewards (positive reinforcement using motivational tokens that represented a benefit of quitting smoking). Negative reinforcement was removed in alpha testing as smokers felt it reminded them of smoking. Measurement of QSU-Brief (N=30) resulted in a pregame mean of 3.24 (SD 1.65) and postgame mean of 2.99 (SD 1.40) with an overall decrease of 0.25 in cravings (not statistically significant). In a subset analysis, the QSU-Brief decrease was significant for smokers abstinent for more than 48 hours (N=5) with a pregame mean of 2.84 (SD 1.16) and a postgame mean of 2.0 (SD 0.94; change=0.84; P =.03). Between December 22, 2011, and May 29, 2014, the game was downloaded 3372 times from the App-Store, with 1526 smokers visiting the online resource www.decide2quit.org linked to the game. Conclusions: Overall, playing the game resulted in small, but nonsignificant decreases in cravings, with changes greater for those had already quit for more than 48 hours. Lessons learned can inform further development. Future research could incorporate mHealth games in multicomponent cessation interventions. Trial Registration: Clinicaltrials.gov NCT00797628; https://clinicaltrials.gov/ct2/show/NCT00797628 (Archived by WebCite at http://www.webcitation.org/6hbJr6LWG) %M 27229772 %R 10.2196/games.4566 %U http://games.jmir.org/2016/1/e3/ %U https://doi.org/10.2196/games.4566 %U http://www.ncbi.nlm.nih.gov/pubmed/27229772 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 5 %P e103 %T Effectiveness of a Web-Based Screening and Fully Automated Brief Motivational Intervention for Adolescent Substance Use: A Randomized Controlled Trial %A Arnaud,Nicolas %A Baldus,Christiane %A Elgán,Tobias H %A De Paepe,Nina %A Tønnesen,Hanne %A Csémy,Ladislav %A Thomasius,Rainer %+ German Centre for Addiction Research in Childhood and Adolescence (DZSKJ), Centre for Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Martinistraße 52, Hamburg, 20246, Germany, 49 040 7410 59861, n.arnaud@uke.de %K substance use %K adolescents %K brief intervention %K web-based intervention %K motivational interviewing %K randomized controlled trial %D 2016 %7 24.05.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Mid-to-late adolescence is a critical period for initiation of alcohol and drug problems, which can be reduced by targeted brief motivational interventions. Web-based brief interventions have advantages in terms of acceptability and accessibility and have shown significant reductions of substance use among college students. However, the evidence is sparse among adolescents with at-risk use of alcohol and other drugs. Objective: This study evaluated the effectiveness of a targeted and fully automated Web-based brief motivational intervention with no face-to-face components on substance use among adolescents screened for at-risk substance use in four European countries. Methods: In an open-access, purely Web-based randomized controlled trial, a convenience sample of adolescents aged 16-18 years from Sweden, Germany, Belgium, and the Czech Republic was recruited using online and offline methods and screened online for at-risk substance use using the CRAFFT (Car, Relax, Alone, Forget, Friends, Trouble) screening instrument. Participants were randomized to a single session brief motivational intervention group or an assessment-only control group but not blinded. Primary outcome was differences in past month drinking measured by a self-reported AUDIT-C-based index score for drinking frequency, quantity, and frequency of binge drinking with measures collected online at baseline and after 3 months. Secondary outcomes were the AUDIT-C-based separate drinking indicators, illegal drug use, and polydrug use. All outcome analyses were conducted with and without Expectation Maximization (EM) imputation of missing follow-up data. Results: In total, 2673 adolescents were screened and 1449 (54.2%) participants were randomized to the intervention or control group. After 3 months, 211 adolescents (14.5%) provided follow-up data. Compared to the control group, results from linear mixed models revealed significant reductions in self-reported past-month drinking in favor of the intervention group in both the non-imputed (P=.010) and the EM-imputed sample (P=.022). Secondary analyses revealed a significant effect on drinking frequency (P=.037) and frequency of binge drinking (P=.044) in the non-imputation-based analyses and drinking quantity (P=.021) when missing data were imputed. Analyses for illegal drug use and polydrug use revealed no significant differences between the study groups (Ps>.05). Conclusions: Although the study is limited by a large drop-out, significant between-group effects for alcohol use indicate that targeted brief motivational intervention in a fully automated Web-based format can be effective to reduce drinking and lessen existing substance use service barriers for at-risk drinking European adolescents. Trial Registration: International Standard Randomized Controlled Trial Registry: ISRCTN95538913; http://www.isrctn.com/ISRCTN95538913 (Archived by WebCite at http://www.webcitation.org/6XkuUEwBx) %M 27220276 %R 10.2196/jmir.4643 %U http://www.jmir.org/2016/5/e103/ %U https://doi.org/10.2196/jmir.4643 %U http://www.ncbi.nlm.nih.gov/pubmed/27220276 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 4 %N 2 %P e49 %T Text Messaging-Based Interventions for Smoking Cessation: A Systematic Review and Meta-Analysis %A Scott-Sheldon,Lori A. J %A Lantini,Ryan %A Jennings,Ernestine G %A Thind,Herpreet %A Rosen,Rochelle K %A Salmoirago-Blotcher,Elena %A Bock,Beth C %+ Centers for Behavioral and Preventive Medicine, The Miriam Hospital, CORO Building, Suite 309, 164 Summit Avenue, Providence, RI, 02906, United States, 1 401 793 8714, lori_scott-sheldon@brown.edu %K text messaging %K smoking cessation %K intervention %K cigarette smoking %K meta-analysis %D 2016 %7 20.05.2016 %9 Review %J JMIR mHealth uHealth %G English %X Background: Tobacco use is one of the leading preventable global health problems producing nearly 6 million smoking-related deaths per year. Interventions delivered via text messaging (short message service, SMS) may increase access to educational and support services that promote smoking cessation across diverse populations. Objective: The purpose of this meta-analysis is to (1) evaluate the efficacy of text messaging interventions on smoking outcomes, (2) determine the robustness of the evidence, and (3) identify moderators of intervention efficacy. Methods: Electronic bibliographic databases were searched for records with relevant key terms. Studies were included if they used a randomized controlled trial (RCT) to examine a text messaging intervention focusing on smoking cessation. Raters coded sample and design characteristics, and intervention content. Summary effect sizes, using random-effects models, were calculated and potential moderators were examined. Results: The meta-analysis included 20 manuscripts with 22 interventions (N=15,593; 8128 (54%) women; mean age=29) from 10 countries. Smokers who received a text messaging intervention were more likely to abstain from smoking relative to controls across a number of measures of smoking abstinence including 7-day point prevalence (odds ratio (OR)=1.38, 95% confidence interval (CI)=1.22, 1.55, k=16) and continuous abstinence (OR=1.63, 95% CI=1.19, 2.24, k=7). Text messaging interventions were also more successful in reducing cigarette consumption relative to controls (d+=0.14, 95% CI=0.05, 0.23, k=9). The effect size estimates were biased when participants who were lost to follow-up were excluded from the analyses. Cumulative meta-analysis using the 18 studies (k=19) measuring abstinence revealed that the benefits of using text message interventions were established only after only five RCTs (k=5) involving 8383 smokers (OR=1.39, 95% CI=1.15, 1.67, P<.001). The inclusion of the subsequent 13 RCTs (k=14) with 6870 smokers did not change the established efficacy of text message interventions for smoking abstinence (OR=1.37, 95% CI=1.25, 1.51, P<.001). Smoking abstinence rates were stronger when text messaging interventions (1) were conducted in Asia, North America, or Europe, (2) sampled fewer women, and (3) recruited participants via the Internet. Conclusions: The evidence for the efficacy of text messaging interventions to reduce smoking behavior is well-established. Using text messaging to support quitting behavior, and ultimately long-term smoking abstinence, should be a public health priority. %M 27207211 %R 10.2196/mhealth.5436 %U http://mhealth.jmir.org/2016/2/e49/ %U https://doi.org/10.2196/mhealth.5436 %U http://www.ncbi.nlm.nih.gov/pubmed/27207211 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 5 %P e107 %T Exploring the Utility of Web-Based Social Media Advertising to Recruit Adult Heavy-Drinking Smokers for Treatment %A Bold,Krysten W %A Hanrahan,Tess H %A O'Malley,Stephanie S %A Fucito,Lisa M %+ Yale School of Medicine, Department of Psychiatry, Connecticut Mental Health Center, 34 Park Street, New Haven, CT, 06519, United States, 1 2039747603, krysten.bold@yale.edu %K smoking %K alcohol drinking %K social media %K research subject recruitment %D 2016 %7 18.05.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Identifying novel ways to recruit smokers for treatment studies is important. In particular, certain subgroups of adult smokers, such as heavy-drinking smokers, are at increased risk for serious medical problems and are less likely to try quitting smoking, so drawing this hard-to-reach population into treatment is important for improving health outcomes. Objective: This study examined the utility of Facebook advertisements to recruit smokers and heavy-drinking smokers for treatment research and evaluated smoking and alcohol use and current treatment goals among those who responded to the Web-based survey. Methods: Using Facebook’s advertising program, 3 separate advertisements ran for 2 months targeting smokers who were thinking about quitting. Advertisements were shown to adult (at least 18 years of age), English-speaking Facebook users in the greater New Haven, Connecticut, area. Participants were invited to complete a Web-based survey to determine initial eligibility for a smoking cessation research study. Results: Advertisements generated 1781 clicks and 272 valid, completed surveys in 2 months, with one advertisement generating the most interest. Facebook advertising was highly cost-effective, averaging $0.27 per click, $1.76 per completed survey, and $4.37 per participant meeting initial screening eligibility. On average, those who completed the Web-based survey were 36.8 (SD 10.4) years old, and 65.8% (179/272) were female. Advertisements were successful in reaching smokers; all respondents reported daily smoking (mean 16.2 [SD 7.0] cigarettes per day). The majority of smokers (254/272, 93.4%) were interested in changing their smoking behavior immediately. Many smokers (161/272, 59.2%) also reported heavy alcohol consumption at least once a month. Among smokers interested in reducing their alcohol use, more were heavy drinkers (45/56, 80.4%) compared to non-heavy drinkers (11/56, 19.6%; χ2[1,N=272]=13.0, P<.001). Of those who met initial screening eligibility from the Web-based survey, 12.7% (14/110) attended an in-person follow-up appointment. Conclusions: Social media advertisements designed to target smokers were cost-effective and successful for reaching adult smokers interested in treatment. Additionally, recruiting for smokers reached those who also drink alcohol heavily, many of whom were interested in changing this behavior as well. However, additional social media strategies may be needed to engage individuals into treatment after completion of Web-based screening surveys. %M 27194456 %R 10.2196/jmir.5360 %U http://www.jmir.org/2016/5/e107/ %U https://doi.org/10.2196/jmir.5360 %U http://www.ncbi.nlm.nih.gov/pubmed/27194456 %0 Journal Article %@ 2292-9495 %I Gunther Eysenbach %V 3 %N 1 %P e13 %T The Usability of Diabetes MAP: A Web-delivered Intervention for Improving Medication Adherence %A Nelson,Lyndsay A %A Bethune,Magaela C %A Lagotte,Andrea E %A Osborn,Chandra Y %+ Center for Health Behavior and Health Education, Vanderbilt University Medical Center, 2525 West End Ave, Suite 370, Nashville, TN, 37203, United States, 1 615 936 8468, chandra.osborn@vanderbilt.edu %K Website %K Usability Testing %K Type 2 Diabetes Mellitus %K Medication Adherence %K Intervention %D 2016 %7 12.05.2016 %9 Original Paper %J JMIR Human Factors %G English %X Background: Web-delivered interventions are a feasible approach to health promotion. However, if a website is poorly designed, difficult to navigate, and has technical bugs, it will not be used as intended. Usability testing prior to evaluating a website’s benefits can identify barriers to user engagement and maximize future use. Objective: We developed a Web-delivered intervention called Diabetes Medication Adherence Promotion (Diabetes MAP) and used a mixed-methods approach to test its usability prior to evaluating its efficacy on medication adherence and glycemic control in a randomized controlled trial. Methods: We recruited English-speaking adults with type 2 diabetes mellitus (T2DM) from an academic medical center who were prescribed diabetes medications. A trained research assistant administered a baseline survey, collected medical record information, and instructed participants on how to access Diabetes MAP. Participants were asked to use the site independently for 2 weeks and to provide survey and/or focus group feedback on their experience. We analyzed survey data descriptively and qualitative data thematically to identify participants’ favorable and unfavorable experiences, characterize usability concerns, and solicit recommendations for improving Diabetes MAP. Results: Enrolled participants (N=32) were an average of 51.7 ± 11.8 years old, 66% (21/32) female, 60% (19/32) non-Hispanic White, 88% (28/32) had more than 12 years of education, half had household incomes over $50,000, and 78% (25/32) were privately insured. Average duration of diagnosed diabetes was 7.8 ± 6.3 years, average A1c was 7.4 ± 2.0, and 38% (12/32) were prescribed insulin. Of enrolled participants, 91% (29/32) provided survey and/or focus group feedback about Diabetes MAP. On the survey, participants agreed website information was clear and easy to understand, but in focus groups they reported navigational challenges and difficulty overcoming user errors (eg, entering data in an unspecified format). Participants also reported difficulty accessing the site and, once accessed, using all of its features. Participants recommended improving the site’s user interface to facilitate quick, efficient access to all features and content. Conclusions: Adults with T2DM rated the Diabetes MAP website favorably on surveys, but focus groups gave more in-depth feedback on the user experience (eg, difficulty accessing the site, maximizing all of the site’s features and content, and recovering from errors). Appropriate usability testing methods ensure Web-delivered interventions work as intended and any benefits are not diminished by usability challenges. %M 27174496 %R 10.2196/humanfactors.5177 %U http://humanfactors.jmir.org/2016/1/e13/ %U https://doi.org/10.2196/humanfactors.5177 %U http://www.ncbi.nlm.nih.gov/pubmed/27174496 %0 Journal Article %@ 2368-7959 %I JMIR Publications Inc. %V 3 %N 2 %P e13 %T Process and Effects Evaluation of a Digital Mental Health Intervention Targeted at Improving Occupational Well-Being: Lessons From an Intervention Study With Failed Adoption %A Muuraiskangas,Salla %A Harjumaa,Marja %A Kaipainen,Kirsikka %A Ermes,Miikka %+ VTT Technical Research Centre of Finland Ltd, Digital Health, Kaitoväylä 1, Oulu, 90590, Finland, 358 207222169, salla.muuraiskangas@vtt.fi %K acceptance and commitment therapy %K intervention studies %K mHealth %K cccupational health %K process assessment %K stress %K mindfulness %K attrition %K adoption %D 2016 %7 11.05.2016 %9 Original Paper %J JMIR Mental Health %G English %X Background: Digital interventions have the potential to serve as cost-effective ways to manage occupational stress and well-being. However, little is known about the adoption of individual-level digital interventions at organizations. Objectives: The aim of this paper is to study the effects of an unguided digital mental health intervention in occupational well-being and the factors that influence the adoption of the intervention. Methods: The intervention was based on acceptance and commitment therapy (ACT) and its aim was to teach skills for stress management and mental well-being. It was delivered via a mobile and a Web-based app that were offered to employees of two information and communication technology (ICT) companies. The primary outcome measures were perceived stress and work engagement, measured by a 1-item stress questionnaire (Stress) and the Utrecht Work Engagement Scale (UWES-9). The intervention process was evaluated regarding the change mechanisms and intervention stages using mixed methods. The initial interviews were conducted face-to-face with human resource managers (n=2) of both companies in August 2013. The participants were recruited via information sessions and email invitations. The intervention period took place between November 2013 and March 2014. The participants were asked to complete online questionnaires at baseline, two months, and four months after the baseline measurement. The final phone interviews for the volunteer participants (n=17) and the human resource managers (n=2) were conducted in April to May 2014, five months after the baseline. Results: Of all the employees, only 27 (8.1%, 27/332) took the app into use, with a mean use of 4.8 (SD 4.7) different days. In the beginning, well-being was on good level in both companies and no significant changes in well-being were observed. The activities of the intervention process failed to integrate the intervention into everyday activities at the workplace. Those who took the app into use experienced many benefits such as relief in stressful situations. The app was perceived as a toolkit for personal well-being that gives concrete instructions on how mindfulness can be practiced. However, many barriers to participate in the intervention were identified at the individual level, such as lack of time, lack of perceived need, and lack of perceived benefits. Conclusions: The findings suggest that neither the setting nor the approach used in this study were successful in adopting new digital interventions at the target organizations. Barriers were faced at both the organizational as well as the individual level. At the organizational level, top management needs to be involved in the intervention planning for fitting into the organization policies, the existing technology infrastructure, and also targeting the organizational goals. At the individual level, concretizing the benefits of the preventive intervention and arranging time for app use at the workplace are likely to increase adoption. %M 27170553 %R 10.2196/mental.4465 %U http://mental.jmir.org/2016/2/e13/ %U https://doi.org/10.2196/mental.4465 %U http://www.ncbi.nlm.nih.gov/pubmed/27170553 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 4 %P e87 %T Testing the Efficacy of OurSpace, a Brief, Group Dynamics-Based Physical Activity Intervention: A Randomized Controlled Trial %A Irwin,Brandon %A Kurz,Daniel %A Chalin,Patrice %A Thompson,Nicholas %+ Digital Physical Activity Laboratory, Department of Kinesiology, Kansas State University, 1A Natatorium, Manhattan, KS, 66506, United States, 1 7855320660, bcirwin@k-state.edu %K physical activity %K group dynamics %K social media %K cohesion %K Internet %K social support %D 2016 %7 06.05.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Emerging technologies (ie, mobile phones, Internet) may be effective tools for promoting physical activity (PA). However, few interventions have provided effective means to enhance social support through these platforms. Face-to-face programs that use group dynamics-based principles of behavior change have been shown to be highly effective in enhancing social support through promoting group cohesion and PA, but to date, no studies have examined their effects in Web-based programs. Objective: The aim was to explore proof of concept and test the efficacy of a brief, online group dynamics-based intervention on PA in a controlled experiment. We expected that the impact of the intervention on PA would be moderated by perceptions of cohesion and the partner’s degree of presence in the online media. Methods: Participants (n=135) were randomized into same-sex dyads and randomly assigned to one of four experimental conditions: standard social support (standard), group dynamics-based–high presence, group dynamics-based–low presence, or individual control. Participants performed two sets of planking exercises (pre-post). Between sets, participants in partnered conditions interacted with a virtual partner using either a standard social support app or a group dynamics-based app (group dynamics-based–low presence and group dynamics-based–high presence), the latter of which they participated in a series of online team-building exercises. Individual participants were given an equivalent rest period between sets. To increase presence during the second set, participants in the group dynamics-based–high presence group saw a live video stream of their partner exercising. Perceptions of cohesion were measured using a modified PA Group Environment Questionnaire. Physical activity was calculated as the time persisted during set 2 after controlling for persistence in set 1. Results: Perceptions of cohesion were higher in the group dynamics-based–low presence (overall mean 5.81, SD 1.04) condition compared to the standard (overall mean 5.04, SD 0.81) conditions (P=.006), but did not differ between group dynamics-based–low presence and group dynamics-based–high presence (overall mean 5.42, SD 1.07) conditions (P=.25). Physical activity was higher in the high presence condition (mean 64.48, SD 20.19, P=.01) than all other conditions (mean 53.3, SD 17.35). Conclusions: A brief, online group dynamics-based intervention may be an effective method of improving group cohesion in virtual PA groups. However, it may be insufficient on its own to improve PA. %M 27154301 %R 10.2196/jmir.5342 %U http://www.jmir.org/2016/4/e87/ %U https://doi.org/10.2196/jmir.5342 %U http://www.ncbi.nlm.nih.gov/pubmed/27154301 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 4 %N 2 %P e39 %T Using Mobile Apps to Promote a Healthy Lifestyle Among Adolescents and Students: A Review of the Theoretical Basis and Lessons Learned %A Dute,Denise Jantine %A Bemelmans,Wanda Jose Erika %A Breda,João %+ National Institute for Public Health and Environment (RIVM), Antonie van Leeuwenhoeklaan 9, P.O. Box 1, 3720 BA, Bilthoven,, Netherlands, 31 30 2744297, wanda.bemelmans@rivm.nl %K mHealth %K mobile phones %K behavior change %K health promotion %K physical activity %K nutrition %K overweight %K adolescents and students %D 2016 %7 05.05.2016 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: European adolescents and students tend to have low levels of physical activity and eat unhealthy foods, and the prevalence of overweight and obesity has increased, which poses a public health challenge. Mobile apps play an important role in their daily lives, suggesting their potential to be used in health-promoting strategies. Objective: This review aimed to explore how mobile apps can contribute to the promotion of healthy nutrition, physical activity, and prevention of overweight in adolescents and students. For the apps identified, the review describes the content, the theoretical mechanisms applied, and lessons learned. Methods: The databases Scopus, MEDLINE, Embase, and PsycINFO were searched for English-language publications from January 2009 to November 2013. Studies were included if (1) the primary component of the intervention involves an app; (2) the intervention targets healthy nutrition, or physical activity, or overweight prevention; and (3) the target group included adolescents or students (aged 12-25 years). Results: A total of 15 studies were included, which describe 12 unique apps. Ten of these apps functioned as monitoring tools for assessing dietary intake or physical activity levels. The other apps used a Web-based platform to challenge users to exercise and to allow users to list and photograph their problem foods. For 5 apps, the behavioral theory underpinning their development was clearly specified. Frequently applied behavior change techniques are prompting self-monitoring of behavior and providing feedback on performance. Apps can function self-contained, but most of them are used as part of therapy or to strengthen school programs. From the age of 10 years users may be capable of using apps. Only 4 apps were developed specifically for adolescents. All apps were tested on a small scale and for a short period. Conclusions: Despite large potential and abundant usage by young people, limited research is available on apps and health promotion for adolescents. Apps seem to be a promising health promotion strategy as a monitoring tool. Apps can enable users to set targets, enhance self‐monitoring, and increase awareness. Three apps incorporated social features, making them “social media,” but hardly any evidence appeared available about their potential. %M 27150850 %R 10.2196/mhealth.3559 %U http://mhealth.jmir.org/2016/2/e39/ %U https://doi.org/10.2196/mhealth.3559 %U http://www.ncbi.nlm.nih.gov/pubmed/27150850 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 4 %P e74 %T An Internet-Based Physical Activity Intervention to Improve Quality of Life of Inactive Older Adults: A Randomized Controlled Trial %A Broekhuizen,Karen %A de Gelder,Jelle %A Wijsman,Carolien A %A Wijsman,Liselotte W %A Westendorp,Rudi GJ %A Verhagen,Evert %A Slagboom,Pieternella E %A de Craen,Anton J %A van Mechelen,Willem %A van Heemst,Diana %A van der Ouderaa,Frans %A Mooijaart,Simon P %+ Leiden University Medical Center, Department of Gerontology and Geriatrics, Albinusdreef 2, 2333 ZA, Leiden, , Netherlands, 31 715266640, s.p.mooijaart@lumc.nl %K Internet %K physical activity %K quality of life %D 2016 %7 27.04.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Increasing physical activity is a viable strategy for improving both the health and quality of life of older adults. Objective: The aim of this study was to assess if an Internet-based intervention aimed to increase physical activity was effective in improving quality of life of inactive older adults. In addition, we analyzed the effect of the intervention on quality of life among those participants who successfully reached their individually targeted increase in daily physical activity as indicated by the intervention program, as well as the dose-response effect of increasing physical activity on quality of life. Methods: The intervention was tested in a randomized controlled trial and was comprised of an Internet program—DirectLife (Philips)—aimed at increasing physical activity using monitoring and feedback by accelerometry and feedback by digital coaching (n=119). The control group received no intervention (n=116). Participants were inactive 60-70-year-olds and were recruited from the general population. Quality of life and physical activity were measured at baseline and after 3 months using the Research ANd Development 36-item health survey (RAND-36) and wrist-worn triaxial accelerometer, respectively. Results: After 3 months, a significant improvement in quality of life was seen in the intervention group compared to the control group for RAND-36 subscales on emotional and mental health (2.52 vs -0.72, respectively; P=.03) and health change (8.99 vs 2.03, respectively; P=.01). A total of 50 of the 119 participants (42.0%) in the intervention group successfully reached their physical activity target and showed a significant improvement in quality of life compared to the control group for subscales on emotional and mental health (4.31 vs -0.72, respectively; P=.009) and health change (11.06 vs 2.03, respectively; P=.004). The dose-response analysis showed that there was a significant association between increase in minutes spent in moderate-to-vigorous physical activity (MVPA) and increase in quality of life. Conclusions: Our study shows that an Internet-based physical activity program was effective in improving quality of life in 60-70-year-olds after 3 months, particularly in participants that reached their individually targeted increase in daily physical activity. Trial Registration: Nederlands Trial Register: NTR 3045; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3045 (Archived by WebCite at http://www.webcitation.org/6fobg2sjJ) %M 27122359 %R 10.2196/jmir.4335 %U http://www.jmir.org/2016/4/e74/ %U https://doi.org/10.2196/jmir.4335 %U http://www.ncbi.nlm.nih.gov/pubmed/27122359 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 4 %P e88 %T The Pros and Cons of Getting Engaged in an Online Social Community Embedded Within Digital Cognitive Behavioral Therapy for Insomnia: Survey Among Users %A Coulson,Neil S %A Smedley,Richard %A Bostock,Sophie %A Kyle,Simon D %A Gollancz,Rosie %A Luik,Annemarie I %A Hames,Peter %A Espie,Colin A %+ Division of Rehabilitation & Ageing, School of Medicine, University of Nottingham, Medical School, Queen's Medical Centre, University of Nottingham, Nottingham, NG7 2UH, United Kingdom, 44 1158466642, neil.coulson@nottingham.ac.uk %K engagement %K sleep %K online community %K discussion forum %K insomnia %K cognitive behavioral therapy %D 2016 %7 25.04.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Sleepio is a proven digital sleep improvement program based on cognitive behavioral therapy techniques. Users have the option to join an online community that includes weekly expert discussions, peer-to-peer discussion forums, and personal message walls. Objective: The aim of this study was to conduct an online survey to (1) explore the reasons for deciding to engage with the Sleepio online community, (2) explore the potential benefits arising from engagement with the online community, and (3) identify and describe any problematic issues related to use of the online community. Methods: We developed an online survey and posted an invitation to the community discussion forum inviting users to participate. In addition, we sent an email invitation to 970 individuals who had previously or were currently working through the Sleepio program to participate in this study. Results: In total, 100 respondents (70/100, 70% female; mean age 51 years, range 26–82 years) completed the online survey. Most respondents had started Sleepio with chronic sleep problems (59/100, 59% up to 10 years; 35/100, 35% >10 years) and had actively engaged with the online community (85/100, 85%) had made a discussion or wall post). At the time of the survey, respondents had used Sleepio for a median of 12 weeks (range from 3 weeks to 2 years). We analyzed responses to the open-ended questions using thematic analysis. This analysis revealed 5 initial drivers for engagement: (1) the desire to connect with people facing similar issues, (2) seeking personalized advice, (3) curiosity, (4) being invited by other members, and (5) wanting to use all available sleep improvement tools. Advantages of engagement included access to continuous support, a reduced sense of isolation, being part of a nonjudgmental community, personalized advice, positive comparisons with others, encouragement to keep going, and altruism. We found 5 potential disadvantages: design and navigation issues, uncertain quality of user-generated content, negative comparisons with others, excessive time commitments, and data privacy concerns. Participants related their community experiences to engagement with the Sleepio program, with many stating it had supported their efforts to improve their sleep, as well as helping with adherence and commitment to the program. Despite some concerns, members regarded the Sleepio community as a valuable resource. Conclusions: Online communities may be a useful means through which to support long-term engagement with Web-based therapy for insomnia. %M 27113540 %R 10.2196/jmir.5654 %U http://www.jmir.org/2016/4/e88/ %U https://doi.org/10.2196/jmir.5654 %U http://www.ncbi.nlm.nih.gov/pubmed/27113540 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 4 %P e92 %T Effectiveness of Social Media Interventions for People With Schizophrenia: A Systematic Review and Meta-Analysis %A Välimäki,Maritta %A Athanasopoulou,Christina %A Lahti,Mari %A Adams,Clive E %+ Department of Nursing Science, University of Turku, Lemminkäisenkatu 1, Turku, 20014, Finland, 358 02 333 8495, mava@utu.fi %K social media %K effectiveness %K technology %K Internet %K Web 2.0 %K schizophrenia %K mental health %D 2016 %7 22.04.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Recent studies have shown that people with serious mental disorders spend time online for the purposes of disclosure, information gathering, or gaming. However, coherent information on the effects of social media on treatment for people with schizophrenia is still lacking. Objective: Our aim was to determine the effects of social media interventions for supporting mental health and well-being among people with schizophrenia. Methods: A systematic review and meta-analysis were undertaken to determine the effects of social media interventions for supporting mental health and well-being among people with schizophrenia. Ten databases were searched, while search parameters included English-only manuscripts published prior to June 25, 2015. Study appraisals were made independently by 2 reviewers, and qualitative and quantitative syntheses of data were conducted. Results: Out of 1043 identified records, only two randomized studies of moderate quality (three records, total N=331, duration 12 months) met the inclusion criteria. Participants were people with schizophrenia spectrum or an affective disorder. Social media was used as part of Web-based psychoeducation, or as online peer support (listserv and bulletin board). Outcome measures included perceived stress, social support, and disease-related distress. At 3 months, participants with schizophrenia in the intervention group reported lower perceived stress levels (P=.04) and showed a trend for a higher perceived level of social support (P=.06). However, those who reported more positive experiences with the peer support group also reported higher levels of psychological distress (P=.01). Conclusions: Despite using comprehensive searches from 10 databases, we found only two studies, whereas numerous reports have been published citing the benefits of social media in mental health. Findings suggest the effects of social media interventions are largely unknown. More research is needed to understand the effects of social media, for users with and without mental illness, in order to determine the impact on mental well-being ofsocial media use as well as its risks. %M 27105939 %R 10.2196/jmir.5385 %U http://www.jmir.org/2016/4/e92/ %U https://doi.org/10.2196/jmir.5385 %U http://www.ncbi.nlm.nih.gov/pubmed/27105939 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 4 %P e93 %T A Web-Based Computer-Tailored Alcohol Prevention Program for Adolescents: Cost-Effectiveness and Intersectoral Costs and Benefits %A Drost,Ruben MWA %A Paulus,Aggie TG %A Jander,Astrid F %A Mercken,Liesbeth %A de Vries,Hein %A Ruwaard,Dirk %A Evers,Silvia MAA %+ Department of Health Services Research, School for Public Health and Primary Care (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Duboisdomein 30, Maastricht, 6229 GT, Netherlands, 31 433881729, r.drost@maastrichtuniversity.nl %K adolescents %K alcohol use %K cluster randomized controlled trial %K game %K computer tailoring %K education %K criminal justice %K costs and cost analysis %K economic evaluation %K intersectoral costs and benefits %D 2016 %7 21.04.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Preventing excessive alcohol use among adolescents is important not only to foster individual and public health, but also to reduce alcohol-related costs inside and outside the health care sector. Computer tailoring can be both effective and cost-effective for working with many lifestyle behaviors, yet the available information on the cost-effectiveness of computer tailoring for reducing alcohol use by adolescents is limited as is information on the costs and benefits pertaining to sectors outside the health care sector, also known as intersectoral costs and benefits (ICBs). Objective: The aim was to assess the cost-effectiveness of a Web-based computer-tailored intervention for reducing alcohol use and binge drinking by adolescents from a health care perspective (excluding ICBs) and from a societal perspective (including ICBs). Methods: Data used were from the Alcoholic Alert study, a cluster randomized controlled trial with randomization at the level of schools into two conditions. Participants either played a game with tailored feedback on alcohol awareness after the baseline assessment (intervention condition) or received care as usual (CAU), meaning that they had the opportunity to play the game subsequent to the final measurement (waiting list control condition). Data were recorded at baseline (T0=January/February 2014) and after 4 months (T1=May/June 2014) and were used to calculate incremental cost-effectiveness ratios (ICERs), both from a health care perspective and a societal perspective. Stochastic uncertainty in the data was dealt with by using nonparametric bootstraps (5000 simulated replications). Additional sensitivity analyses were conducted based on excluding cost outliers. Subgroup cost-effectiveness analyses were conducted based on several background variables, including gender, age, educational level, religion, and ethnicity. Results: From both the health care perspective and the societal perspective for both outcome measures, the intervention was more costly and more effective in comparison with CAU. ICERs differed for both perspectives, namely €40 and €79 from the health care perspective to €62 and €144 for the societal perspective per incremental reduction of one glass of alcohol per week and one binge drinking occasion per 30 days, respectively. Subgroup analyses showed, from both perspectives and for both outcome measures, that the intervention was cost-effective for older adolescents (aged 17-19 years) and those at a lower educational level and, from a health care perspective, the male and nonreligious adolescent subgroups. Conclusions: Computer-tailored feedback could be a cost-effective way to target alcohol use and binge drinking among adolescents. Including ICBs in the economic evaluation had an impact on the cost-effectiveness results of the analysis. It could be worthwhile to aim the intervention specifically at specific subgroups. Trial Registration: Nederlands Trial Register: NTR4048; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4048 (Archived by Webcite at http://www.webcitation.org/6c7omN8wG) %M 27103154 %R 10.2196/jmir.5223 %U http://www.jmir.org/2016/4/e93/ %U https://doi.org/10.2196/jmir.5223 %U http://www.ncbi.nlm.nih.gov/pubmed/27103154 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 4 %P e83 %T Evaluation of QuitNow Men: An Online, Men-Centered Smoking Cessation Intervention %A Bottorff,Joan L %A Oliffe,John L %A Sarbit,Gayl %A Sharp,Paul %A Caperchione,Cristina M %A Currie,Leanne M %A Schmid,Jonathan %A Mackay,Martha H %A Stolp,Sean %+ Institute for Healthy Living and Chronic Disease Prevention, University of British Columbia, 1147 Research Road, Art 223, Kelowna, BC, V1V 1V7, Canada, 1 250 807 8627, joan.bottorff@ubc.ca %K smoking cessation %K web-based health promotion %K internet %K masculinity %K men's health %D 2016 %7 20.04.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Men continue to smoke cigarettes in greater numbers than women. There is growing evidence for the value of developing targeted, men-centered health promotion programs. However, few smoking cessation interventions have been designed for men. A gender-specific website, QuitNow Men, was developed based on focus group interview findings, stakeholder feedback, and evidence-based cessation strategies. The website was designed to incorporate a masculine look and feel through the use of images, direct language, and interactive content. Usability experts and end-users provided feedback on navigation and functionality of the website prior to pilot testing. Objectives: The objectives of the pilot study were to describe (1) men’s use and evaluations of the interactive resources and information on the QuitNow Men website, and (2) the potential of QuitNow Men to engage men in reducing and quitting smoking. Methods: A one-group, pretest-posttest study design was used. Men who were interested in quitting were recruited and invited to use the website over a 6-month period. Data were collected via online questionnaires at baseline, 3-month, and 6-month follow-up. A total of 117 men completed the baseline survey. Over half of those (67/117, 57.3%) completed both follow-up surveys. Results: At baseline, participants (N=117) had been smoking for an average of 24 years (SD 12.1) and smoked on average 15 cigarettes a day (SD 7.4). The majority had not previously used a quit smoking website (103/117, 88.0%) or websites focused on men’s health (105/117, 89.7%). At the 6-month follow-up, the majority of men used the QuitNow Men website at least once (64/67, 96%). Among the 64 users, 29 (43%) reported using the website more than 6 times. The men using QuitNow Men agreed or strongly agreed that the website was easy to use (51/64, 80%), the design and images were appealing (42/64, 66%), they intended to continue to use the website (42/64, 66%), and that they would recommend QuitNow Men to others who wanted to quit (46/64, 72%). Participants reported using an average of 8.76 (SD 4.08) of the 15 resources available on the website. At 6-month follow-up, 16 of the 67 participants (24%) had quit, 27 (40%) had reduced their smoking and 24 (36%) had not changed their smoking habits. Repeated measures general linear model showed a significant decrease in the number of cigarettes smoked between the 3-month and 6-month follow-up (F1,63=6.41, P=.01, eta squared=0.09). Number of resources used on the website, quit confidence, nicotine dependence and age significantly predicted number of quit attempts by those still smoking at 6 months (F4,45=2.73, P=.04), with number of resources used being the strongest predictor (P=.02). Conclusions: The results of this research support efforts to integrate gender-sensitive approaches in smoking cessation interventions and indicate that this novel Web-based resource has potential in supporting men’s smoking cessation efforts. %M 27097991 %R 10.2196/jmir.5076 %U http://www.jmir.org/2016/4/e83/ %U https://doi.org/10.2196/jmir.5076 %U http://www.ncbi.nlm.nih.gov/pubmed/27097991 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 4 %P e86 %T The Impact of Automated Brief Messages Promoting Lifestyle Changes Delivered Via Mobile Devices to People with Type 2 Diabetes: A Systematic Literature Review and Meta-Analysis of Controlled Trials %A Arambepola,Carukshi %A Ricci-Cabello,Ignacio %A Manikavasagam,Pavithra %A Roberts,Nia %A French,David P %A Farmer,Andrew %+ University of Oxford, Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, Woodstock Road, Oxford., Oxford, OX2 6GG, United Kingdom, 44 01865 617190, ignacio.riccicabello@phc.ox.ac.uk %K Diabetes mellitus, type 2 %K mobile health %K text messaging %K systematic review %K diet %K physical activity %K self-care %D 2016 %7 19.04.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Brief automated messages have the potential to support self-management in people with type 2 diabetes, but their effect compared with usual care is unclear. Objective: To examine the effectiveness of interventions to change lifestyle behavior delivered via automated brief messaging in patients with type 2 diabetes. Methods: A systematic literature review of controlled trials examined the impact of interventions, delivered by brief messaging, and intended to promote lifestyle change in people with type 2 diabetes, on behavioral and clinical outcomes. Bibliographic databases searched included Medline, Embase, CINAHL, PsycINFO, and ISI WoK. Two reviewers independently screened citations. We extracted information on study risk of bias, setting (high versus low- and middle-income countries) and intervention characteristics (including use of theory and behavior-change techniques). Outcome measures included acceptability of the interventions and their impact on 1) determinants of lifestyle behavior (knowledge about diabetes, self-efficacy, attitudes towards self-management), 2) lifestyle behavior (diet, physical activity), and 3) clinical and patient-reported outcomes. Where possible, we pooled data using random-effects meta-analyses to obtain estimates of effect size of intervention compared to usual care. Results: We identified 15 trials (15 interventions) meeting our inclusion criteria. Most interventions were delivered via short message service text messaging (n=12) and simultaneously targeted diet and physical activity (n=11). Nine interventions consisted of unidirectional messages, whereas six consisted of bidirectional messages, with patients receiving automated tailored feedback based on self-reported data. The acceptability of the interventions, and their impact on lifestyle behavior and its determinants, were examined in a low proportion of trials, with heterogeneous results being observed. In 13 trials (1155 patients) where data were available, there was a difference in glycated hemoglobin of -0.53% (95% CI -0.59% to -0.47%) between intervention groups compared to usual care. In five trials (406 patients) there was a non-significant difference in body mass index of -0.25 kg/m2 (95% CI -1.02 to 0.52). Interventions based on unidirectional messages produced similar effects in the outcomes examined, compared to those based on bidirectional messages. Interventions conducted in low- and middle-income countries showed a greater impact than those conducted in high-income countries. In general, trials were not free of bias and did not use explicit theory. Conclusions: Automated brief messages strategies can improve health outcomes in people with type 2 diabetes. Larger, methodologically robust trials are needed to confirm these positive results. %M 27095386 %R 10.2196/jmir.5425 %U http://www.jmir.org/2016/4/e86/ %U https://doi.org/10.2196/jmir.5425 %U http://www.ncbi.nlm.nih.gov/pubmed/27095386 %0 Journal Article %@ 1929-073X %I JMIR Publications Inc. %V 5 %N 2 %P e10 %T YouTube Videos to Create a “Virtual Hospital Experience” for Hip and Knee Replacement Patients to Decrease Preoperative Anxiety: A Randomized Trial %A O'Connor,Mary I %A Brennan,Katharyn %A Kazmerchak,Shari %A Pratt,Jason %+ Center for Musculoskeletal Care, Department of Orthopaedics and Rehabilitation, Yale School of Medicine, 1450 Chapel Street, Selina Lewis 4th Floor, New Haven, CT, 06511, United States, 1 203 789 4378, mary.oconnor@yale.edu %K hip arthroplasty %K hip replacement %K knee arthroplasty %K knee replacement %K preoperative anxiety %K virtual hospital experience %K YouTube videos %D 2016 %7 18.04.2016 %9 Original Paper %J Interact J Med Res %G English %X Background: With declining reimbursement to health care systems, face-to-face time between patients and providers to optimize preoperative education and counseling may be challenging. Objective: Because high patient anxiety prior to surgery has been linked to more severe and persistent pain after joint replacement surgery, the Orthopedic Surgery Department at Mayo Clinic in Florida created a playlist of 16 YouTube videos aimed at creating a virtual hospital experience for primary total hip and knee joint replacement patients. A randomized trial was then performed to evaluate the potential impact of viewing this playlist on preoperative anxiety. Methods: Each patient completed a Generalized Anxiety Disorder (GAD) score assessment at the time of the routine preoperative clinic visit and then randomized based on his/her gender, type of surgery, and initial GAD score to either the control group of standard education (education at face-to-face clinical visits as well as printed educational materials) or the treatment group (standard education plus access to the YouTube playlist). On the morning of the patient’s surgery, the same survey was repeated. Of the 65 patients who consented to participate in the study, 53 completed the study (82%) with 28 of 29 (97% completed) in the control group and 25 of 36 (69% completed) in the treatment group. Results: Overall, the results showed a trend toward less anxiety in patients who viewed the YouTube videos; this was exhibited by a reduction in the median GAD score by 1 point. This trend is more clearly present in patients with high preoperative anxiety (predominantly women), as seen in the reduction of the median GAD score by 6 points in the treatment group. Conclusions: Although our experience is limited, our results indicate that a series of tailored videos may decrease patient anxiety preoperatively. We recommend further exploration of both this concept and the use of social media tools in preoperative patient education. Trial Registration: Clinicaltrials.gov NCT02546180; http://clinicaltrials.gov/ct2/show/NCT02546180 (Archived by WebCite at http://www.webcitation.org/6f6y0Dw7d). %M 27091674 %R 10.2196/ijmr.4295 %U http://www.i-jmr.org/2016/2/e10/ %U https://doi.org/10.2196/ijmr.4295 %U http://www.ncbi.nlm.nih.gov/pubmed/27091674 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 4 %P e82 %T Enhancement of Self-Monitoring in a Web-Based Weight Loss Program by Extra Individualized Feedback and Reminders: Randomized Trial %A Hutchesson,Melinda Jane %A Tan,Chor Yin %A Morgan,Philip %A Callister,Robin %A Collins,Clare %+ School of Health Sciences, Faculty of Health and Medicine, University of Newcastle, Advanced Technology Centre, Level 3, University Drive, Callaghan, 2308, Australia, 61 2 49215646, clare.collins@newcastle.edu.au %K weight loss %K Web-based intervention %K randomized controlled trial %K commercial weight loss program %K self-monitoring %D 2016 %7 12.04.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Self-monitoring is an essential behavioral strategy for effective weight loss programs. Traditionally, self-monitoring has been achieved using paper-based records. However, technology is now more frequently used to deliver treatment programs to overweight and obese adults. Information technologies, such as the Internet and mobile phones, allow innovative intervention features to be incorporated into treatment that may facilitate greater adherence to self-monitoring processes, provide motivation for behavior change, and ultimately lead to greater weight loss success. Objective: The objective of our study was to determine whether the consistency of self-monitoring differed between participants randomly assigned to a basic or an enhanced 12-week commercial Web-based weight loss program. Methods: We randomly assigned a sample of 301 adults (mean age 42.3 years; body mass index 31.3 kg/m2; female 176/301, 58.5%) to the basic or enhanced group. The basic program included tools for self-monitoring (online food and exercise diary, and a weekly weigh-in log) with some feedback and reminders to weigh in (by text or email). The enhanced program included the basic components, as well as extra individualized feedback on self-monitoring entries and reminders (by text, email, or telephone) to engage with self-monitoring tools. We evaluated the level of self-monitoring by examining the consistency of self-monitoring of food, exercise, and weight during the 12 weeks. Consistency was defined as the number of weeks during which participants completed a criterion number of entries (ie, ≥3 days of online food or exercise diary records per week and ≥1 weigh-in per week). Results: The enhanced group’s consistency of use of self-monitoring tools was significantly greater than that of the basic group throughout the 12 weeks (median consistency for food 8 vs 3 weeks, respectively, P<.001; for exercise 2.5 vs 1 weeks, respectively, P=.003). Conclusions: Enhanced features, including additional individualized feedback and reminders, are effective in enhancing self-monitoring behaviors in a Web-based weight loss program. ClinicalTrial: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12610000197033; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=335159 (Archived by WebCite at http://www.webcitation.org/6gCQdj21G) %M 27072817 %R 10.2196/jmir.4100 %U http://www.jmir.org/2016/4/e82/ %U https://doi.org/10.2196/jmir.4100 %U http://www.ncbi.nlm.nih.gov/pubmed/27072817 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 4 %P e78 %T Effectiveness of a Web-Based Computer-Tailored Multiple-Lifestyle Intervention for People Interested in Reducing their Cardiovascular Risk: A Randomized Controlled Trial %A Storm,Vera %A Dörenkämper,Julia %A Reinwand,Dominique Alexandra %A Wienert,Julian %A De Vries,Hein %A Lippke,Sonia %+ Department of Psychology and Methods, Jacobs University Bremen, Campus Ring 1, Bremen, 28759, Germany, 49 421200 ext 4721, v.storm@jacobs-university.de %K Web-based intervention %K computer tailoring %K cardiovascular disease %K habit strength %K self-efficacy %K planning %D 2016 %7 11.04.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based computer-tailored interventions for multiple health behaviors can improve the strength of behavior habits in people who want to reduce their cardiovascular risk. Nonetheless, few randomized controlled trials have tested this assumption to date. Objective: The study aim was to test an 8-week Web-based computer-tailored intervention designed to improve habit strength for physical activity and fruit and vegetable consumption among people who want to reduce their cardiovascular risk. In a randomized controlled design, self-reported changes in perceived habit strength, self-efficacy, and planning across different domains of physical activity as well as fruit and vegetable consumption were evaluated. Methods: This study was a randomized controlled trial involving an intervention group (n=403) and a waiting control group (n=387). Web-based data collection was performed in Germany and the Netherlands during 2013-2015. The intervention content was based on the Health Action Process Approach and involved personalized feedback on lifestyle behaviors, which indicated whether participants complied with behavioral guidelines for physical activity and fruit and vegetable consumption. There were three Web-based assessments: baseline (T0, N=790), a posttest 8 weeks after the baseline (T1, n=206), and a follow-up 3 months after the baseline (T2, n=121). Data analysis was conducted by analyzing variances and structural equation analysis. Results: Significant group by time interactions revealed superior treatment effects for the intervention group, with substantially higher increases in self-reported habit strength for physical activity (F1,199=7.71, P=.006, Cohen’s d=0.37) and fruit and vegetable consumption (F1,199=7.71, P=.006, Cohen’s d=0.30) at posttest T1 for the intervention group. Mediation analyses yielded behavior-specific sequential mediator effects for T1 planning and T1 self-efficacy between the intervention and habit strength at follow-up T2 (fruit and vegetable consumption: beta=0.12, 95% CI 0.09-0.16, P<.001; physical activity: beta=0.04, 95% CI 0.02-0.06, P<.001). Conclusions: Our findings indicate the general effectiveness and practicality of Web-based computer-tailored interventions in terms of increasing self-reported habit strength for physical activity and fruit and vegetable consumption. Self-efficacy and planning may play major roles in the mechanisms that facilitate the habit strength of these behaviors; therefore, they should be actively promoted in Web-based interventions. Although the results need to take into account the high dropout rates and medium effect sizes, a large number of people were reached and changes in habit strength were achieved after 3 months. Trial Registration: Clinicaltrials.gov NCT01909349; https://clinicaltrials.gov/ct2/show/NCT01909349 (Archived by WebCite at http://www.webcitation.org/6g5F0qoft) and Nederlands Trial Register NTR3706 http://www.trialregister.nl/ trialreg/admin/rctview.asp?TC=3706 (Archived by WebCite at http://www.webcitation.org/6g5F5HMLX) %M 27068880 %R 10.2196/jmir.5147 %U http://www.jmir.org/2016/4/e78/ %U https://doi.org/10.2196/jmir.5147 %U http://www.ncbi.nlm.nih.gov/pubmed/27068880 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 4 %N 2 %P e28 %T User Perceptions of ¡Protéjase!: An Intervention Designed to Increase Protective Equipment Use Among Mexican Immigrant and Mexican American Farmworkers %A Snipes,Shedra A %A Montiel-Ishino,Francisco A %A Smyth,Joshua M %A Murphy,Dennis J %A Miranda,Patricia Y %A Davis,Lisa A %+ Penn State University, Department of Biobehavioral Health, 125 Biobehavioral Health Building, University Park, PA, , United States, 1 814 865 4668, sas84@psu.edu %K mHealth %K Hispanic %K migrant worker %K intervention study %K pesticides %K occupational safety %D 2016 %7 11.04.2016 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: Farmworkers’ exposures to pesticides are reduced when they wear personal protective equipment (PPE), and mobile health (mHealth) platforms can potentially deliver information to farmworkers to help promote PPE use. However, little is known about the feasibility of using mHealth platforms to promote farmworkers’ use of PPE. Objective: The objective of the study was to describe the development and feasibility-testing of Protect Yourself! (¡Protéjase!), an intervention designed to increase PPE use. As the vast majority of farmworkers in the United States are from Mexico, we examined the intervention in a primarily Mexican-origin farmworker population. Methods: ¡Protéjase was developed in several steps. First, we performed ethnographic observations to understand what prevents PPE use. Next, we developed program components that met the challenges uncovered in the ethnographic observations, seeking direct feedback from farmworkers on each component. Feasibility was assessed using surveys and focus groups. Material was provided in Spanish or English at the preference of the participant. Finally, we pilot tested each component of the intervention, including: (1) PPE that was provided to each worker for their personal use during the intervention trial, and (2) delivery of an application-based tool that promoted the use of PPE through daily individualized messaging. Results: 55 farmworkers enrolled in the study, but only 41 of 55 (75%) completed the entire pilot intervention trial. Results focus on the evaluation of the intervention, and include only those who completed the entire trial. Among farmworkers who completed the entire intervention trial, all but two farmworkers were born in Mexico and were Spanish speaking. Still, all study participants self-identified as Mexican or Mexican-American. When asked what changes were needed in the intervention’s messaging or delivery to increase user satisfaction, 22 out of 41 participants (54%) felt that no changes were needed. However, 16 of 41 participants (39%) suggested small changes to messaging (eg, refer to long pants as pants only) to improve their understanding of the messages. Finally, a small number (3 of 41 participants, 7%) felt that messages were difficult to read, primarily due to low literacy. Conclusions: The ¡Protéjase! mHealth program demonstrated very good feasibility, satisfaction, and acceptance; potential improvements (eg, small modifications in messaging to increase farmworkers’ use) were noted. Overall, the PPE provided to workers as well as the mHealth platform were both perceived as useful for promoting PPE use. %M 27066727 %R 10.2196/mhealth.4455 %U http://mhealth.jmir.org/2016/2/e28/ %U https://doi.org/10.2196/mhealth.4455 %U http://www.ncbi.nlm.nih.gov/pubmed/27066727 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 4 %P e58 %T Efficacy and External Validity of Electronic and Mobile Phone-Based Interventions Promoting Vegetable Intake in Young Adults: Systematic Review and Meta-Analysis %A Nour,Monica %A Chen,Juliana %A Allman-Farinelli,Margaret %+ School of Life and Environmental Sciences, University of Sydney, Level 4 East, Charles Perkins Centre D17, The University of Sydney, Sydney, NSW, 2006, Australia, 61 403094095, mnou2973@uni.sydney.edu.au %K young adults %K vegetable consumption %K mHealth %K eHealth %K social marketing %D 2016 %7 08.04.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Young adults (18–35 years) remain among the lowest vegetable consumers in many western countries. The digital era offers opportunities to engage this age group in interventions in new and appealing ways. Objective: This systematic review evaluated the efficacy and external validity of electronic (eHealth) and mobile phone (mHealth) -based interventions that promote vegetable intake in young adults. Methods: We searched several electronic databases for studies published between 1990 and 2015, and 2 independent authors reviewed the quality and risk of bias of the eligible papers and extracted data for analyses. The primary outcome of interest was the change in vegetable intake postintervention. Where possible, we calculated effect sizes (Cohen d and 95% CIs) for comparison. A random effects model was applied to the data for meta-analysis. Reach and representativeness of participants, intervention implementation, and program maintenance were assessed to establish external validity. Published validation studies were consulted to determine the validity of tools used to measure intake. We applied the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to evaluate the overall quality of the body of evidence. Results: Of the 14 studies that met the selection criteria, we included 12 in the meta-analysis. In the meta-analysis, 7 studies found positive effects postintervention for fruit and vegetable intake, Cohen d 0.14–0.56 (pooled effect size 0.22, 95% CI 0.11–0.33, I2=68.5%, P=.002), and 4 recorded positive effects on vegetable intake alone, Cohen d 0.11–0.40 (pooled effect size 0.15, 95% CI 0.04–0.28, I2=31.4%, P=.2). These findings should be interpreted with caution due to variability in intervention design and outcome measures. With the majority of outcomes documented as a change in combined fruit and vegetable intake, it was difficult to determine intervention effects on vegetable consumption specifically. Measurement of intake was most commonly by self-report, with 5 studies using nonvalidated tools. Longer-term follow-up was lacking from most studies (n=12). Risk of bias was high among the included studies, and the overall body of evidence was rated as low quality. The applicability of interventions to the broader young adult community was unclear due to poor description of external validity components. Conclusions: Preliminary evidence suggests that eHealth and mHealth strategies may be effective in improving vegetable intake in young adults; whether these small effects have clinical or nutritional significance remains questionable. With studies predominantly reporting outcomes as fruit and vegetable intake combined, we suggest that interventions report vegetables separately. Furthermore, to confidently establish the efficacy of these strategies, better-quality interventions are needed for young adults, using valid measures of intake, with improved reporting on costs, sustainability and long-term effects of programs. Trial registration: PROSPERO International Prospective Register of Systematic Reviews: CRD42015017763; http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42015017763 (Archived by WebCite at http://www.webcitation.org/6fLhMgUP4) %M 27059765 %R 10.2196/jmir.5082 %U http://www.jmir.org/2016/4/e58/ %U https://doi.org/10.2196/jmir.5082 %U http://www.ncbi.nlm.nih.gov/pubmed/27059765 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 2 %P e47 %T Usefulness of a Tailored eHealth Service for Informal Caregivers and Professionals in the Dementia Treatment and Care Setting: The eHealthMonitor Dementia Portal %A Schaller,Sandra %A Marinova-Schmidt,Velislava %A Setzer,Manuela %A Kondylakis,Haridimos %A Griebel,Lena %A Sedlmayr,Martin %A Graessel,Elmar %A Maler,Juan Manuel %A Kirn,Stefan %A Kolominsky-Rabas,Peter L %+ Interdisciplinary Centre for Health Technology Assessment (HTA) and Public Health, Friedrich-Alexander-University of Erlangen-Nürnberg, Schwabachanlage 6, Erlangen, 91054, Germany, 49 9131 8534167, sandra.schaller@uk-erlangen.de %K eHealth %K web portal %K decision aid %K personalized support %K dementia %K Alzheimer’s disease %K informal caregiver %K medical professional %D 2016 %7 05.04.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: The European eHealthMonitor project (eHM) developed a user-sensitive and interactive Web portal for the dementia care setting called the eHM Dementia Portal (eHM-DP). It aims to provide targeted support for informal caregivers of persons with dementia and professionals. Objective: The objective of this study was to assess the usefulness and impact of the eHM-DP service in the dementia care setting from two user perspectives: informal caregivers and professionals. Methods: The evaluation study was conducted from June to September 2014 and followed a before-after, user-participatory, mixed-method design with questionnaires and interviews. The used intervention was the eHM-DP: an interactive Web portal for informal caregivers and professionals that was tested for a 12-week period. Primary outcomes for caregivers included empowerment, quality of life, caregiver burden, decision aid, as well as perceived usefulness and benefits of the eHM-DP. Primary outcomes for professionals involved decision aid, perceived usefulness, and benefits of the eHM-DP. Results: A total of 25 informal caregivers and 6 professionals used the eHM-DP over the 12-week study period. Both professionals and informal caregivers indicated perceived benefits and support by the eHM-DP. In total, 65% (16/25) of informal caregivers would use the eHM-DP if they had access to it. Major perceived benefits were individualized information acquisition, improved interaction between informal caregivers and professionals, access to support from home, and empowerment in health-related decisions (PrepDM Score: 67.9). Professionals highlighted the improved treatment and care over the disease course (83%, 5/6) and improved health care access for people living in rural areas (67%, 4/6). However, there was no improvement in caregiver burden (Burden Scale for Family Caregivers) and quality of life (EuroQol-5D-5L) over the study period. Conclusions: Our study provides insight into the different user perspectives on an eHealth support service in the dementia treatment and care setting. These results are of importance for future developments and the uptake of eHealth solutions in the dementia domain and reinforce the importance of early user involvement. Turning to the primary target of the eHM-DP service, our findings suggest that the eHM-DP service proved to be a valuable post-diagnostic support service, in particular for the home-based care setting. Further research on a larger scale is needed to enhance the implementation in existing health care infrastructures. %M 27050401 %R 10.2196/resprot.4354 %U http://www.researchprotocols.org/2016/2/e47/ %U https://doi.org/10.2196/resprot.4354 %U http://www.ncbi.nlm.nih.gov/pubmed/27050401 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 4 %P e69 %T Cardiac Patients’ Walking Activity Determined by a Step Counter in Cardiac Telerehabilitation: Data From the Intervention Arm of a Randomized Controlled Trial %A Thorup,Charlotte %A Hansen,John %A Grønkjær,Mette %A Andreasen,Jan Jesper %A Nielsen,Gitte %A Sørensen,Erik Elgaard %A Dinesen,Birthe Irene %+ Department of Cardiothoracic Surgery, Aalborg University Hospital, Søndre Skovvej 5, 313, Aalborg, 9000, Denmark, 45 20729950, cbt@rn.dk %K heart disease %K rehabilitation %K step counters %K physical activity %K telerehabilitation %D 2016 %7 04.04.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Walking represents a large part of daily physical activity. It reduces both overall and cardiovascular diseases and mortality and is suitable for cardiac patients. A step counter measures walking activity and might be a motivational tool to increase and maintain physical activity. There is a lack of knowledge about both cardiac patients’ adherence to step counter use in a cardiac telerehabilitation program and how many steps cardiac patients walk up to 1 year after a cardiac event. Objective: The purpose of this substudy was to explore cardiac patients’ walking activity. The walking activity was analyzed in relation to duration of pedometer use to determine correlations between walking activity, demographics, and medical and rehabilitation data. Methods: A total of 64 patients from a randomized controlled telerehabilitation trial (Teledi@log) from Aalborg University Hospital and Hjoerring Hospital, Denmark, from December 2012 to March 2014 were included in this study. Inclusion criteria were patients hospitalized with acute coronary syndrome, heart failure, and coronary artery bypass grafting or valve surgery. In Teledi@log, the patients received telerehabilitation technology and selected one of three telerehabilitation settings: a call center, a community health care center, or a hospital. Monitoring of steps continued for 12 months and a step counter (Fitbit Zip) was used to monitor daily steps. Results: Cardiac patients walked a mean 5899 (SD 3274) steps per day, increasing from mean 5191 (SD 3198) steps per day in the first week to mean 7890 (SD 2629) steps per day after 1 year. Adherence to step counter use lasted for a mean 160 (SD 100) days. The patients who walked significantly more were younger (P=.01) and continued to use the pedometer for a longer period (P=.04). Furthermore, less physically active patients weighed more. There were no significant differences in mean steps per day for patients in the three rehabilitation settings or in the disease groups. Conclusions: This study indicates that cardiac telerehabilitation at a call center can support walking activity just as effectively as telerehabilitation at either a hospital or a health care center. In this study, the patients tended to walk fewer steps per day than cardiac patients in comparable studies, but our study may represent a more realistic picture of walking activity due to the continuation of step counter use. Qualitative studies on patients’ behavior and motivation regarding step counter use are needed to shed light on adherence to and motivation to use step counters. Trial Registration: ClinicalTrails.gov NCT01752192; https://clinicaltrials.gov/ct2/show/NCT01752192 (Archived by WebCite at http://www.webcitation.org/6fgigfUyV) %M 27044310 %R 10.2196/jmir.5191 %U http://www.jmir.org/2016/4/e69/ %U https://doi.org/10.2196/jmir.5191 %U http://www.ncbi.nlm.nih.gov/pubmed/27044310 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 3 %P e80 %T Effectiveness of a Web-Based Guided Self-help Intervention for Outpatients With a Depressive Disorder: Short-term Results From a Randomized Controlled Trial %A Kenter,Robin Maria Francisca %A Cuijpers,Pim %A Beekman,Aartjan %A van Straten,Annemieke %+ Faculty of Behavioural and Movement Sciences, Department of Clinical, Neuro and Developmental Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, Amsterdam, 1081 BT, Netherlands, 31 20 59 88970, robin.kenter@vu.nl %K depression %K outpatient clinics %K Internet-based treatment %K problem solving therapy %K specialized mental health care %D 2016 %7 31.03.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Research has convincingly demonstrated that symptoms of depression can be reduced through guided Internet-based interventions. However, most of those studies recruited people form the general population. There is insufficient evidence for the effectiveness when delivered in routine clinical practice in outpatient clinics. Objective: The objective of this randomized controlled trial was to study patients with a depressive disorder (as defined by the Diagnostic and Statistical Manual of Disorders, fourth edition), as assessed by trained interviewers with the Composite International Diagnostic Interview, who registered for treatment at an outpatient mental health clinic. We aimed to examine the effectiveness of guided Internet-based self-help before starting face-to-face treatment. Methods: We recruited 269 outpatients, aged between 18 and 79 years, from outpatient clinics and randomly allocated them to Internet-based problem solving therapy (n=136), with weekly student support, or to a control condition, who remained on the waitlist with a self-help booklet (control group; n=133). Participants in both conditions were allowed to take up face-to-face treatment at the outpatient clinics afterward. We measured the primary outcome, depressive symptoms, by Center for Epidemiological Studies Depression scale (CES-D). Secondary outcome measures were the Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A), Insomnia Severity Index questionnaire (ISI), and EuroQol visual analog scale (EQ-5D VAS). All outcomes were assessed by telephone at posttest (8 weeks after baseline). Results: Posttest measures were completed by 184 (68.4%) participants. We found a moderate to large within-group effect size for both the intervention (d=0.75) and the control (d=0.69) group. However, the between-group effect size was very small (d=0.07), and regression analysis on posttreatment CES-D scores revealed no significant differences between the groups (b=1.134, 95% CI –2.495 to 4.763). The per-protocol analysis (≥4 sessions completed) results were also not significant (b=1.154, 95% CI –1.978 to 7.637). Between-group differences were small and not significant for all secondary outcomes. Adherence to the intervention was low. Only 36% (49/136) received an adequate dosage of the intervention (≥4 of 5 sessions). The overall treatment satisfaction was moderate. Conclusions: Internet-based problem solving therapy is not more effective in reducing symptoms of depression than receiving an unguided self-help book during the waitlist period at outpatient mental health clinics. The effect sizes are much smaller than those found in earlier research in the general population, and the low rates of adherence indicate that the acceptability of the intervention at this stage of treatment for depressed outpatients is low. However, taking into account that there is much evidence for the efficacy of Internet-based treatments, it is too early to draw firm conclusions about the effectiveness of these treatments in outpatient clinics as a whole. Trial Registration: Netherlands Trial Register NTR2824; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2824 (Archived by WebCite at http://www.webcitation/ 6g3WEuiqH) %M 27032449 %R 10.2196/jmir.4861 %U http://www.jmir.org/2016/3/e80/ %U https://doi.org/10.2196/jmir.4861 %U http://www.ncbi.nlm.nih.gov/pubmed/27032449 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 3 %P e71 %T An Online Intervention for Co-Occurring Depression and Problematic Alcohol Use in Young People: Primary Outcomes From a Randomized Controlled Trial %A Deady,Mark %A Mills,Katherine L %A Teesson,Maree %A Kay-Lambkin,Frances %+ National Health and Medical Research Council Centre for Research Excellence in Mental Health and Substance Use, National Drug and Alcohol Research Centre, University of New South Wales, Kensington, 2052, Australia, 61 293850320, m.deady@unsw.edu.au %K depression %K alcohol use, alcohol abuse, problem drinking %K young people at risk populations %K Internet %K intervention online therapy, eHealth %K comorbidity %D 2016 %7 23.03.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression and problematic alcohol use represent two of the major causes of disease burden in young adults. These conditions frequently co-occur and this is associated with increased harm and poorer outcomes than either disorder in isolation. Integrated treatments have been shown to be effective; however, there remains a significant gap between those in need of treatment and those receiving it. The increased availability of eHealth programs presents a unique opportunity to treat these conditions. Objective: This study aimed to evaluate the feasibility and preliminary efficacy of an automated Web-based self-help intervention (DEAL Project) in treating co-occurring depressive symptoms and problematic alcohol use in young people. Methods: Young people (aged 18 to 25 years) with moderate depression symptoms and drinking at hazardous levels (recruited largely via social media) were randomly allocated to the DEAL Project (n=60) or a Web-based attention-control condition (HealthWatch; n=44). The trial consisted of a 4-week intervention phase with follow-up assessment at posttreatment and at 3 and 6 months postbaseline. The primary outcomes were change in depression severity according to the Patient Health Questionnaire-9 as well as quantity and frequency of alcohol use (TOT-AL). Results: The DEAL Project was associated with statistically significant improvement in depression symptom severity (d=0.71) and reductions in alcohol use quantity (d=0.99) and frequency (d=0.76) in the short term compared to the control group. At 6-month follow-up, the improvements in the intervention group were maintained; however, the differences between the intervention and control groups were no longer statistically significant, such that between-group effects were in the small to moderate range at 6 months (depression symptoms: d=0.39; alcohol quantity: d=–0.09; alcohol frequency: d=0.24). Conclusions: Overall, the DEAL Project was associated with more rapid improvement in both depression symptoms and alcohol use outcomes in young people with these co-occurring conditions relative to an attention-control condition. However, long-term outcomes are less clear. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000033741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363461 (Archived by WebCite at http://www.webcitation.org/6fpsLEGOy) %M 27009465 %R 10.2196/jmir.5178 %U http://www.jmir.org/2016/3/e71/ %U https://doi.org/10.2196/jmir.5178 %U http://www.ncbi.nlm.nih.gov/pubmed/27009465 %0 Journal Article %@ 2368-7959 %I JMIR Publications Inc. %V 3 %N 1 %P e11 %T Adjusting an Available Online Peer Support Platform in a Program to Supplement the Treatment of Perinatal Depression and Anxiety %A Baumel,Amit %A Schueller,Stephen M %+ The Feinstein Institute for Medical Research, 350 Community Dr, Manhasset, NY, 11030, United States, 1 7184708267, abaumel@northwell.edu %K online %K peer %K support %K perinatal %K postpartum %K depression %K anxiety %D 2016 %7 21.03.2016 %9 Original Paper %J JMIR Mental Health %G English %X Background: Perinatal depression and anxiety are common and debilitating conditions. Novel, cost effective services could improve the uptake and the impact of mental health resources among women who suffer from these conditions. E-mental health products are one example of such services. Many publically available e-mental health products exist, but these products lack validation and are not designed to be integrated into existing health care settings. Objective: The objective of the study was to present a program to use 7 Cups of Tea (7Cups), an available technological platform that provides online peer (ie, listener) based emotional support, to supplement treatment for women experiencing perinatal depression or anxiety and to summarize patient’s feedback on the resultant program. Methods: This study consisted of two stages. First, five clinicians specializing in the treatment of perinatal mood disorders received an overview of 7Cups. They provided feedback on the 7Cups platform and ways it could complement the existing treatment efforts to inform further adjustments. In the second stage, nine women with perinatal depression or anxiety used the platform for a single session and provided feedback. Results: In response to clinicians’ feedback, guidelines for referring patients to use 7Cups as a supplement for treatment were created, and a training program for listeners was developed. Patients found the platform usable and useful and their attitudes toward the trained listeners were positive. Overall, patients noted a need for support outside the scheduled therapy time and believed that freely available online emotional support could help meet this need. Most patients were interested in receiving support from first time mothers and those who suffered in the past from perinatal mood disorders. Conclusions: The study results highlight the use of 7Cups as a tool to introduce accessible and available support into existing treatment for women who suffer from perinatal mood disorders. Further research should focus on the benefits accrued from such a service. However, this article highlights how a publicly available eHealth product can be leveraged to create new services in a health care setting. %M 27001373 %R 10.2196/mental.5335 %U http://mental.jmir.org/2016/1/e11/ %U https://doi.org/10.2196/mental.5335 %U http://www.ncbi.nlm.nih.gov/pubmed/27001373 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 3 %P e55 %T Web-Based Interventions Targeting Cardiovascular Risk Factors in Middle-Aged and Older People: A Systematic Review and Meta-Analysis %A Beishuizen,Cathrien RL %A Stephan,Blossom CM %A van Gool,Willem A %A Brayne,Carol %A Peters,Ron JG %A Andrieu,Sandrine %A Kivipelto,Miia %A Soininen,Hilkka %A Busschers,Wim B %A Moll van Charante,Eric P %A Richard,Edo %+ Academic Medical Center, Department of Neurology, University of Amsterdam, PO Box 22660, Amsterdam, 1100 DD, Netherlands, 31 20 5663446, e.richard@amc.uva.nl %K eHealth %K cardiovascular disease %K prevention %K older people %K aging %K systematic review %K meta-analysis %D 2016 %7 11.03.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based interventions can improve single cardiovascular risk factors in adult populations. In view of global aging and the associated increasing burden of cardiovascular disease, older people form an important target population as well. Objective: In this systematic review and meta-analysis, we evaluated whether Web-based interventions for cardiovascular risk factor management reduce the risk of cardiovascular disease in older people. Methods: Embase, Medline, Cochrane and CINAHL were systematically searched from January 1995 to November 2014. Search terms included cardiovascular risk factors and diseases (specified), Web-based interventions (and synonyms) and randomized controlled trial. Two authors independently performed study selection, data-extraction and risk of bias assessment. In a meta-analysis, outcomes regarding treatment effects on cardiovascular risk factors (blood pressure, glycated hemoglobin A1c (HbA1C), low-density lipoprotein (LDL) cholesterol, smoking status, weight and physical inactivity) and incident cardiovascular disease were pooled with random effects models. Results: A total of 57 studies (N=19,862) fulfilled eligibility criteria and 47 studies contributed to the meta-analysis. A significant reduction in systolic blood pressure (mean difference –2.66 mmHg, 95% CI –3.81 to –1.52), diastolic blood pressure (mean difference –1.26 mmHg, 95% CI –1.92 to –0.60), HbA1c level (mean difference –0.13%, 95% CI –0.22 to –0.05), LDL cholesterol level (mean difference –2.18 mg/dL, 95% CI –3.96 to –0.41), weight (mean difference –1.34 kg, 95% CI –1.91 to –0.77), and an increase of physical activity (standardized mean difference 0.25, 95% CI 0.10-0.39) in the Web-based intervention group was found. The observed effects were more pronounced in studies with short (<12 months) follow-up and studies that combined the Internet application with human support (blended care). No difference in incident cardiovascular disease was found between groups (6 studies). Conclusions: Web-based interventions have the potential to improve the cardiovascular risk profile of older people, but the effects are modest and decline with time. Currently, there is insufficient evidence for an effect on incident cardiovascular disease. A focus on long-term effects, clinical endpoints, and strategies to increase sustainability of treatment effects is recommended for future studies. %M 26968879 %R 10.2196/jmir.5218 %U http://www.jmir.org/2016/3/e55/ %U https://doi.org/10.2196/jmir.5218 %U http://www.ncbi.nlm.nih.gov/pubmed/26968879 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 3 %P e52 %T Motivation and Treatment Credibility Predicts Dropout, Treatment Adherence, and Clinical Outcomes in an Internet-Based Cognitive Behavioral Relaxation Program: A Randomized Controlled Trial %A Alfonsson,Sven %A Olsson,Erik %A Hursti,Timo %+ Clinical Psychology in Healthcare, Department of Public Health and Caring Sciences, Uppsala University, Husargatan/Dag Hammarskjölds väg, BMC ingång A11, Uppsala, 751 22, Sweden, 46 18 471 00 00, sven.alfonsson@pubcare.uu.se %K Internet %K adherence %K psychotherapy %K motivation %K patient compliance %D 2016 %7 08.03.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: In previous research, variables such as age, education, treatment credibility, and therapeutic alliance have shown to affect patients’ treatment adherence and outcome in Internet-based psychotherapy. A more detailed understanding of how such variables are associated with different measures of adherence and clinical outcomes may help in designing more effective online therapy. Objective: The aims of this study were to investigate demographical, psychological, and treatment-specific variables that could predict dropout, treatment adherence, and treatment outcomes in a study of online relaxation for mild to moderate stress symptoms. Methods: Participant dropout and attrition as well as data from self-report instruments completed before, during, and after the online relaxation program were analyzed. Multiple linear and logistical regression analyses were conducted to predict early dropout, overall attrition, online treatment progress, number of registered relaxation exercises, posttreatment symptom levels, and reliable improvement. Results: Dropout was significantly predicted by treatment credibility, whereas overall attrition was associated with reporting a focus on immediate consequences and experiencing a low level of intrinsic motivation for the treatment. Treatment progress was predicted by education level and treatment credibility, whereas number of registered relaxation exercises was associated with experiencing intrinsic motivation for the treatment. Posttreatment stress symptoms were positively predicted by feeling external pressure to participate in the treatment and negatively predicted by treatment credibility. Reporting reliable symptom improvement after treatment was predicted by treatment credibility and therapeutic bond. Conclusions: This study confirmed that treatment credibility and a good working alliance are factors associated with successful Internet-based psychotherapy. Further, the study showed that measuring adherence in different ways provides somewhat different results, which underscore the importance of carefully defining treatment adherence in psychotherapy research. Lastly, the results suggest that finding the treatment interesting and engaging may help patients carry through with the intervention and complete prescribed assignments, a result that may help guide the design of future interventions. Trial Registration: Clinicaltrials.gov NCT02535598; http://clinicaltrials.gov/ct2/show/NCT02535598 (Archived by WebCite at http://www.webcitation.org/6fl38ms7y). %M 26957354 %R 10.2196/jmir.5352 %U http://www.jmir.org/2016/3/e52/ %U https://doi.org/10.2196/jmir.5352 %U http://www.ncbi.nlm.nih.gov/pubmed/26957354 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 3 %P e42 %T Collective-Intelligence Recommender Systems: Advancing Computer Tailoring for Health Behavior Change Into the 21st Century %A Sadasivam,Rajani Shankar %A Cutrona,Sarah L %A Kinney,Rebecca L %A Marlin,Benjamin M %A Mazor,Kathleen M %A Lemon,Stephenie C %A Houston,Thomas K %+ Division of Health Informatics and Implementation Science, Department of Quantitative Health Science, University of Massachusetts Medical School, 368 Plantation Street, Worcester, MA, , United States, 1 5088568924, rajani.sadasivam@umassmed.edu %K computer-tailored health communication %K machine learning %K recommender systems %D 2016 %7 07.03.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: What is the next frontier for computer-tailored health communication (CTHC) research? In current CTHC systems, study designers who have expertise in behavioral theory and mapping theory into CTHC systems select the variables and develop the rules that specify how the content should be tailored, based on their knowledge of the targeted population, the literature, and health behavior theories. In collective-intelligence recommender systems (hereafter recommender systems) used by Web 2.0 companies (eg, Netflix and Amazon), machine learning algorithms combine user profiles and continuous feedback ratings of content (from themselves and other users) to empirically tailor content. Augmenting current theory-based CTHC with empirical recommender systems could be evaluated as the next frontier for CTHC. Objective: The objective of our study was to uncover barriers and challenges to using recommender systems in health promotion. Methods: We conducted a focused literature review, interviewed subject experts (n=8), and synthesized the results. Results: We describe (1) limitations of current CTHC systems, (2) advantages of incorporating recommender systems to move CTHC forward, and (3) challenges to incorporating recommender systems into CTHC. Based on the evidence presented, we propose a future research agenda for CTHC systems. Conclusions: We promote discussion of ways to move CTHC into the 21st century by incorporation of recommender systems. %M 26952574 %R 10.2196/jmir.4448 %U http://www.jmir.org/2016/3/e42/ %U https://doi.org/10.2196/jmir.4448 %U http://www.ncbi.nlm.nih.gov/pubmed/26952574 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 3 %P e54 %T Internet Cognitive Behavioral Therapy for Women With Postnatal Depression: A Randomized Controlled Trial of MumMoodBooster %A Milgrom,Jeannette %A Danaher,Brian G %A Gemmill,Alan W %A Holt,Charlene %A Holt,Christopher J %A Seeley,John R %A Tyler,Milagra S %A Ross,Jessica %A Ericksen,Jennifer %+ Parent-Infant Research Institute, Department of Clinical & Health Psychology, Heidelberg Repatriation Hospital Austin Health 330 Waterdale Road Heidelberg Heights, Melbourne, 3081, Australia, 61 03 9496 ext 4468, alan.gemmill@austin.org.au %K postnatal depression %K postpartum depression %K cognitive behavioral therapy %K Internet-based intervention %K randomized controlled trial %D 2016 %7 07.03.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: There are few published controlled trials examining the efficacy of Internet-based treatment for postnatal depression (PND) and none that assess diagnostic status (clinical remission) as the primary outcome. This is despite the need to improve treatment uptake and accessibility because fewer than 50% of postnatally depressed women seek help, even when identified as depressed. Objective: In a randomized controlled trial (RCT), we aimed to test the efficacy of a 6-session Internet intervention (the MumMoodBooster program, previously evaluated in a feasibility trial) in a sample of postnatal women with a clinical diagnosis of depression. The MumMoodBooster program is a cognitive behavioral therapy (CBT) intervention, is highly interactive, includes a partner website, and was supported by low-intensity telephone coaching. Methods: This was a parallel 2-group RCT (N=43) comparing the Internet CBT treatment (n=21) to treatment as usual (n=22). At baseline and at 12 weeks after enrollment, women’s diagnostic status was assessed by telephone with the Standardized Clinical Interview for DSM-IV (SCID-IV) and symptom severity with the Beck Depression Inventory (BDI-II). Depression symptoms were measured repeatedly throughout the study period with the Patient Health Questionnaire (PHQ-9). Results: At the end of the study, 79% (15/19) of women who received the Internet CBT treatment no longer met diagnostic criteria for depression on the SCID-IV (these outcome data were missing for 2 intervention participants). This contrasted with only 18% (4/22) remission in the treatment as usual condition. Depression scores on the BDI-II showed a large effect favoring the intervention group (d=.83, 95% CI 0.20-1.45). Small to medium effects were found on the PHQ-9 and on measures of anxiety and stress. Adherence to the program was very good with 86% (18/21) of users completing all sessions; satisfaction with the program was rated 3.1 out of 4 on average. Conclusions: Our results suggest that our Internet CBT program, MumMoodBooster, is an effective treatment option for women clinically diagnosed with PND. This is one of only two controlled evaluations of specialized online psychological treatment among women clinically diagnosed with PND. MumMoodBooster appears to be a feasible, effective treatment option, which is potentially accessible to large numbers of women in metropolitan, rural, and remote areas. Future work might be focused profitably on establishing comparability with face-to-face treatments and purely self-guided delivery. We have commenced a larger RCT comparing MumMoodBooster with face-to-face CBT. Trial Registration: Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000113752; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363561 (Archived by WebCite® at http://www.webcitation.org/6f64kuyLf). %M 26952645 %R 10.2196/jmir.4993 %U http://www.jmir.org/2016/3/e54/ %U https://doi.org/10.2196/jmir.4993 %U http://www.ncbi.nlm.nih.gov/pubmed/26952645 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 2 %P e47 %T Effect of the Web-Based Intervention MyPlan 1.0 on Self-Reported Fruit and Vegetable Intake in Adults Who Visit General Practice: A Quasi-Experimental Trial %A Plaete,Jolien %A Crombez,Geert %A Van der Mispel,Celien %A Verloigne,Maite %A Van Stappen,Vicky %A De Bourdeaudhuij,Ilse %+ Ghent University, Watersportlaan 2, Ghent, 9000, Belgium, 32 92646363, jolien.plaete@ugent.be %K eHealth %K Web-based intervention %K dietary interventions %K fruit and vegetable intake %K general practice %K self-regulation %K health promotion %K primary prevention %D 2016 %7 29.02.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based interventions typically have small intervention effects on adults’ health behavior because they primarily target processes leading to an intention to change leaving individuals in an intention-behavior gap, they often occur without contact with health care providers, and a limited amount of feedback is provided only at the beginning of these interventions, but not further on in the behavior change process. Therefore, we developed a Web-based intervention (“MyPlan 1.0”) to promote healthy behavior in adults. The intervention was based on a self-regulation perspective that also targets postintentional processes and guides individuals during all phases of behavior change. Objective: The study investigated the effectiveness of MyPlan1.0 on fruit and vegetable intake of Flemish adults visiting general practice (3 groups: control group, intervention group recruited by researchers, and intervention group recruited and guided by general practitioners [GPs]). Second, it examined whether there was a larger intervention effect for the intervention group guided by GPs compared to the intervention group recruited by researchers. Methods: Adults (≥18 years) were recruited in 19 Flemish general practices. In each general practice, patients were systematically allocated by a researcher either for the intervention group (researchers’ intervention group) or the waiting-list control group that received general advice. In a third group, the GP recruited adults for the intervention (GPs intervention group). The two intervention groups filled in evaluation questionnaires and received MyPlan 1.0 for a behavior of choice (fruit, vegetable, or physical activity). The waiting-list control group filled in the evaluation questionnaires and received only general information. Self-reported fruit and vegetable intake were assessed at baseline (T0), 1 week (T1), and 1 month (T2) postbaseline. Three-level (general practice, adults, time) linear regression models were conducted in MLwiN. Results: A total of 426 adults initially agreed to participate (control group: n=149; GPs’ intervention group: n=41; researchers’ intervention group: n=236). A high attrition rate was observed in both intervention groups (71.8%, 199/277) and in the control group (59.1%, 88/149). In comparison to no change in the control group, both the GPs’ intervention group (fruit: χ21=10.9, P=.004; vegetable: χ21=5.3, P=.02) and the researchers’ intervention group (fruit: χ21=18.0, P=.001; vegetable: χ21=12.8, P<.001) increased their intake of fruit and vegetables. Conclusions: A greater increase in fruit and vegetable intake was found when the Web-based intervention MyPlan 1.0 was used compared to usual care of health promotion in general practice (ie, flyers with general information). However, further investigation on which (or combinations of which) behavior change techniques are effective, how to increase response rates, and the influence of delivery mode in routine practice is required. Trial Registration: ClinicalTrials.gov NCT02211040; https://clinicaltrials.gov/ct2/show/NCT02211040 (Archived by WebCite® at http://www.webcitation.org/6f8yxTRii) %M 26929095 %R 10.2196/jmir.5252 %U http://www.jmir.org/2016/2/e47/ %U https://doi.org/10.2196/jmir.5252 %U http://www.ncbi.nlm.nih.gov/pubmed/26929095 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e29 %T An Electronic Wellness Program to Improve Diet and Exercise in College Students: A Pilot Study %A Schweitzer,Amy L %A Ross,Jamisha T %A Klein,Catherine J %A Lei,Kai Y %A Mackey,Eleanor R %+ Children's National Health System, Clinical Research Center, 111 Michigan Avenue NW Room 3233A, Washington, DC, 20010, United States, 1 202 476 6331, aschweit@childrensnational.org %K college students, eHealth, telemedicine, diet, intervention studies, obesity, exercise %D 2016 %7 29.02.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: In transitioning from adolescence to adulthood, college students are faced with significant challenges to their health habits. Independence, stress, and perceived lack of time by college students have been known to result in poor eating and exercise habits, which can lead to increased disease risk. Objective: To assess the feasibility and to determine preliminary efficacy of an electronic wellness program in improving diet and physical activity in college students. Methods: A 24-week diet and physical activity program was delivered via email to 148 college students. The intervention involved weekly, tailored, and interactive diet and physical activity goals. The control group received nondiet and nonexercise-related health fact sheets. Anthropometric and blood pressure measurements, as well as food frequency and physical activity surveys were conducted at baseline, week 12, and week 24. Students’ choice of fruit as a snack was also monitored at study visits. Results: Students were 18-20 years old, 69% female, and from a diverse college campus (46% Caucasian, 23% Asian, 20% African American, 11% other). At week 24, 84% of students reported reading at least half of all emails. Mean change (standard error [SE]) from baseline of saturated fat intake was marginally significant between the treatment groups at week 24, 0.7 (SE 0.42) % kcal for control and -0.3 (SE 0.30) % kcal for intervention (P=0.048). A significant difference in percent of snacks chosen that were fruit (χ21, N=221 = 11.7, P<0.001) was detected between the intervention and control group at week 24. Conclusions: Use of an electronic wellness program is feasible in college students and resulted in a decrease in saturated fat intake and an increase in observed fruit intake compared to a control group. %M 26929118 %R 10.2196/resprot.4855 %U http://www.researchprotocols.org/2016/1/e29/ %U https://doi.org/10.2196/resprot.4855 %U http://www.ncbi.nlm.nih.gov/pubmed/26929118 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e30 %T Assessing the Feasibility of a Web-Based Weight Loss Intervention for Low-Income Women of Reproductive Age: A Pilot Study %A Cavallo,David N %A Sisneros,Jessica A %A Ronay,Ashley A %A Robbins,Cheryl L %A Jilcott Pitts,Stephanie B %A Keyserling,Thomas C %A Ni,Ai %A Morrow,John %A Vu,Maihan B %A Johnston,Larry F %A Samuel-Hodge,Carmen D %+ Case Western Reserve University, Department of Nutrition, School of Medicine – WG48, 10900 Euclid Avenue, Cleveland, OH, 44106-4954, United States, 1 216 368 6627, david.cavallo@case.edu %K Obesity %K Nutrition %K Physical Activity %K Minority Health %K Healthcare Disparities %K Intervention Studies %K Internet %K women %K weight loss %K mhealth %D 2016 %7 26.02.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Low-income women of reproductive age are at increased risk for obesity and resulting increases in the risk of maternal/fetal complications and mortality and morbidity. Very few weight-loss interventions, however, have been targeted to this high-risk group. Based on the high prevalence of social media use among young and low-income individuals and previous successes using group formats for weight-loss interventions, the use of social media as a platform for weight-loss intervention delivery may benefit low-income women of reproductive age. Objective: Examine the feasibility of delivering group-based weight-loss interventions to low-income women of reproductive age using face-to-face meetings and Web-based modalities including social media. Methods: Participants attended a family planning clinic in eastern North Carolina and received a 5-month, group- and Web-based, face-to-face weight-loss intervention. Measures were assessed at baseline and 20 weeks. Results: Forty participants enrolled, including 29 (73%) African American women. The mean body mass index of enrollees was 39 kg/m2. Among the 12 women who completed follow-up, mean weight change was -1.3 kg. Participation in the intervention was modest and retention at 5 months was 30%. Returnees suggested sending reminders to improve participation and adding activities to increase familiarity among participants. Conclusions: Engagement with the intervention was limited and attrition was high. Additional formative work on the barriers and facilitators to participation may improve the intervention’s feasibility with low-income women of reproductive age. %M 26920252 %R 10.2196/resprot.4865 %U http://www.researchprotocols.org/2016/1/e30/ %U https://doi.org/10.2196/resprot.4865 %U http://www.ncbi.nlm.nih.gov/pubmed/26920252 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 2 %P e40 %T An eHealth Diary and Symptom-Tracking Tool Combined With Person-Centered Care for Improving Self-Efficacy After a Diagnosis of Acute Coronary Syndrome: A Substudy of a Randomized Controlled Trial %A Wolf,Axel %A Fors,Andreas %A Ulin,Kerstin %A Thorn,Jörgen %A Swedberg,Karl %A Ekman,Inger %+ Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Arvid Wallgrensbacke 20, Gothenburg, 40530, Sweden, 46 7866034 ext 6034, axel.wolf@gu.se %K person-centred care: telemedicine %K mobile health %K eHealth %K patient-centered care %K self-efficacy %K acute coronary syndrome %D 2016 %7 23.02.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Patients with cardiovascular diseases managed by a person-centered care (PCC) approach have been observed to have better treatment outcomes and satisfaction than with traditional care. eHealth may facilitate the often slow transition to more person-centered health care by increasing patients’ beliefs in their own capacities (self-efficacy) to manage their care trajectory. eHealth is being increasingly used, but most studies continue to focus on health care professionals’ logic of care. Knowledge is lacking regarding the effects of an eHealth tool on self-efficacy when combined with PCC for patients with chronic heart diseases. Objective: The objective of our study was to investigate the effect of an eHealth diary and symptom-tracking tool in combination with PCC for patients with acute coronary syndrome (ACS). Methods: This was a substudy of a randomized controlled trial investigating the effects of PCC in patients hospitalized with ACS. In total, 199 patients with ACS aged <75 years were randomly assigned to a PCC intervention (n=94) or standard treatment (control group, n=105) and were followed up for 6 months. Patients in the intervention arm could choose to use a Web-based or mobile-based eHealth tool, or both, for at least 2 months after hospital discharge. The primary end point was a composite score of changes in general self-efficacy, return to work or prior activity level, and rehospitalization or death 6 months after discharge. Results: Of the 94 patients in the intervention arm, 37 (39%) used the eHealth tool at least once after the index hospitalization. Most of these (24/37, 65%) used the mobile app and not the Web-based app as the primary source of daily self-rating input. Patients used the eHealth tool a mean of 38 times during the first 8 weeks (range 1–118, SD 33) and 64 times over a 6-month period (range 1–597, SD 104). Patients who used the eHealth tool in combination with the PCC intervention had a 4-fold improvement in the primary end point compared with the control group (odds ratio 4.0, 95% CI 1.5–10.5; P=.005). This improvement was driven by a significant increase in general self-efficacy compared with the control group (P=.011). Patients in the PCC group who did not use the eHealth tool (n=57) showed a nonsignificant composite score improvement compared with those in the control group (n=105) (odds ratio 2.0, 95% CI 0.8–5.2; P=.14). Conclusions: We found a significant effect on improved general self-efficacy and the composite score for patients using an eHealth diary and symptom-tracking tool in combination with PCC compared with traditional care. Trial Registration: Swedish registry, Researchweb.org, ID NR 65 791. %M 26907584 %R 10.2196/jmir.4890 %U http://www.jmir.org/2016/2/e40/ %U https://doi.org/10.2196/jmir.4890 %U http://www.ncbi.nlm.nih.gov/pubmed/26907584 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 2 %P e36 %T The Efficacy of Three Modalities of Internet-Based Psychotherapy for Non–Treatment-Seeking Online Problem Gamblers: A Randomized Controlled Trial %A Luquiens,Amandine %A Tanguy,Marie-Laure %A Lagadec,Marthylle %A Benyamina,Amine %A Aubin,Henri-Jean %A Reynaud,Michel %+ Paul Brousse Hospital, APHP, Villejuif - University Paris-Sud - Inserm U1178 - CESP, Department of Addiction, 12 avenue Paul Vaillant-Couturier, Villejuif cedex, 94804, France, 33 145594018, amandineluquiens@yahoo.fr %K internet-based cognitive behavioral therapy %K brief intervention %K internet-based randomized controlled trial %K problem gambling %K non-help seeking %K poker %K guidance %D 2016 %7 15.02.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-based interventions targeted at the most at-risk gamblers could reduce the treatment gap for addictive disorders. Currently, no clinical trial has included non–treatment-seeking patients who have been recruited directly in their gambling environment. This study was the first exclusively Internet-based randomized controlled trial among non–help-seeking problem gamblers with naturalistic recruitment in their gambling environment. Objective: The aim of this study was to assess the efficacy of three modalities of Internet-based psychotherapies with or without guidance, compared to a control condition, among problem gamblers who play online poker. Methods: All active poker gamblers on the Winamax website were systematically offered screening. All problem poker gamblers identified with a Problem Gambling Severity Index (PGSI) score of ≥5 were eligible to be included in the trial. Problem gamblers were randomized into four groups: (1) waiting list (control group), (2) personalized normalized feedback on their gambling status by email, (3) an email containing a self-help book to be downloaded with a Cognitive Behavioral Therapy (CBT) program without guidance, and (4) the same CBT program emailed weekly by a trained psychologist with personalized guidance. Efficacy was assessed based on the change in PGSI between baseline and 6 weeks (end of treatment) or 12 weeks (maintenance) and supported by player account-based gambling data automatically collected at the three time points. Results: All groups met high attrition rates (83%), but the group with guidance had a significantly higher dropout rate than the other three groups, including the control group. Although all groups showed some improvement, with a mean decrease of 1.35 on the PGSI, no significant difference in efficacy between the groups was observed. One-third of the problem gamblers fell below the problem gambling threshold at 6 weeks. Conclusions: Guidance could have aversively affected problem gamblers who had not sought help. Despite the lack of significant difference in efficacy between groups, this naturalistic trial provides a basis for the development of future Internet-based trials in individuals with gambling disorders. Comorbidities, natural course of illness, and intrinsic motivation seem to be critical issues to consider in future designs. Trial Registration: ANSM 2013-A00794-41 %M 26878894 %R 10.2196/jmir.4752 %U http://www.jmir.org/2016/2/e36/ %U https://doi.org/10.2196/jmir.4752 %U http://www.ncbi.nlm.nih.gov/pubmed/26878894 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 2 %P e27 %T Effects of a Web-Based Intervention for Stress Reduction in Primary Care: A Cluster Randomized Controlled Trial %A Mehring,Michael %A Haag,Max %A Linde,Klaus %A Wagenpfeil,Stefan %A Schneider,Antonius %+ Institute of General Practice, Klinikum rechts der Isar, Technische Universität München, Orleansstr. 47, Munich, 81667, Germany, 49 614658914, michael.mehring@tum.de %K Web-based %K randomized controlled trial %K life stress %K stress reduction %D 2016 %7 12.02.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Preliminary findings suggest that Web-based interventions may be effective in achieving significant stress reduction. To date, there are no findings available for primary care patients. This is the first study that investigates a Web-based intervention for stress reduction in primary care. Objective: The aim was to examine the short-term effectiveness of a fully automated Web-based coaching program regarding stress reduction in a primary care setting. Methods: The study was an unblinded cluster randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education, motivation, exercise guidance, daily text message reminders, and weekly feedback through the Internet. All components of the program were fully automated. Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program. The main outcome was change in the Perceived Stress Questionnaire (PSQ) over 12 weeks. Results: A total of 93 participants (40 in intervention group, 53 in control group) were recruited into the study. For 25 participants from the intervention group and 49 participants from the control group, PSQ scores at baseline and 12 weeks were available. In the intention-to-treat analysis, the PSQ score decreased by mean 8.2 (SD 12.7) in the intervention group and by mean 12.6 (SD 14.7) in the control group. There was no significant difference identified between the groups (mean difference –4.5, 95% CI –10.2 to 1.3, P=.13). Conclusions: This trial could not show that the tested Web-based intervention was effective for reducing stress compared to usual care. The limited statistical power and the high dropout rate may have reduced the study’s ability to detect significant differences between the groups. Further randomized controlled trials are needed with larger populations to investigate the long-term outcome as well as the contents of usual primary care. Trial Registration: German Clinical Trials Register DRKS00003067; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?=DRKS00003067 (Archived by WebCite at http://www.webcitation.org/6eXk0PXmO) %M 26872703 %R 10.2196/jmir.4246 %U http://www.jmir.org/2016/2/e27/ %U https://doi.org/10.2196/jmir.4246 %U http://www.ncbi.nlm.nih.gov/pubmed/26872703 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e20 %T Effectiveness of Computer Tailoring Versus Peer Support Web-Based Interventions in Promoting Physical Activity Among Insufficiently Active Canadian Adults With Type 2 Diabetes: Protocol for a Randomized Controlled Trial %A Boudreau,François %A Moreau,Michel %A Côté,José %+ Interdisciplinary Group of Health Applied Research, Department of Nursing, Université du Québec à Trois-Rivières, 3351, boul des Forges, Trois-Rivières, QC, G9A 5H7, Canada, 1 819 376 5011 ext 3465, francois.boudreau@uqtr.ca %K physical activity %K behavior modification %K computer tailoring %K personalization %K Facebook %K peer support %K Internet %K World Wide Web %K eHealth %K diabetes mellitus, Type 2 %K motor activity %K behavior therapy %K self-help groups %K telemedicine %D 2016 %7 11.02.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Type 2 diabetes is a major challenge for Canadian public health authorities, and regular physical activity is a key factor in the management of this disease. Given that less than half of people with type 2 diabetes in Canada are sufficiently active to meet the Canadian Diabetes Association's guidelines, effective programs targeting the adoption of regular physical activity are in demand for this population. Many researchers have argued that Web-based interventions targeting physical activity are a promising avenue for insufficiently active populations; however, it remains unclear if this type of intervention is effective among people with type 2 diabetes. Objective: This research project aims to evaluate the effectiveness of two Web-based interventions targeting the adoption of regular aerobic physical activity among insufficiently active adult Canadian Francophones with type 2 diabetes. Methods: A 3-arm, parallel randomized controlled trial with 2 experimental groups and 1 control group was conducted in the province of Quebec, Canada. A total of 234 participants were randomized at a 1:1:1 ratio to receive an 8-week, fully automated, computer-tailored, Web-based intervention (experimental group 1); an 8-week peer support (ie, Facebook group) Web-based intervention (experimental group 2); or no intervention (control group) during the study period. Results: The primary outcome of this study is self-reported physical activity level (total min/week of moderate-intensity aerobic physical activity). Secondary outcomes are attitude, social influence, self-efficacy, type of motivation, and intention. All outcomes are assessed at baseline and 3 and 9 months after baseline with a self-reported questionnaire filled directly on the study websites. Conclusions: By evaluating and comparing the effectiveness of 2 Web-based interventions characterized by different behavior change perspectives, findings of this study will contribute to advances in the field of physical activity promotion in adult populations with type 2 diabetes. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN15747108; http://www.isrctn.com/ISRCTN15747108 (Archived by WebCite at http://www.webcitation.org/6eJTi0m3r) %M 26869015 %R 10.2196/resprot.5019 %U http://www.researchprotocols.org/2016/1/e20/ %U https://doi.org/10.2196/resprot.5019 %U http://www.ncbi.nlm.nih.gov/pubmed/26869015 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 2 %P e34 %T Effectiveness of an Activity Tracker- and Internet-Based Adaptive Walking Program for Adults: A Randomized Controlled Trial %A Poirier,Josée %A Bennett,Wendy L %A Jerome,Gerald J %A Shah,Nina G %A Lazo,Mariana %A Yeh,Hsin-Chieh %A Clark,Jeanne M %A Cobb,Nathan K %+ Division of Pulmonary and Critical Care Medicine, Georgetown University Medical Center, Main Building, 4th Floor, 3800 Reservoir Road, NW, Washington, DC, 20007, United States, 1 202 444 8830, nkc4@georgetown.edu %K physical activity %K walking %K intervention %K adaptive %K effectiveness %K RCT %D 2016 %7 09.02.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: The benefits of physical activity are well documented, but scalable programs to promote activity are needed. Interventions that assign tailored and dynamically adjusting goals could effect significant increases in physical activity but have not yet been implemented at scale. Objective: Our aim was to examine the effectiveness of an open access, Internet-based walking program that assigns daily step goals tailored to each participant. Methods: A two-arm, pragmatic randomized controlled trial compared the intervention to no treatment. Participants were recruited from a workplace setting and randomized to a no-treatment control (n=133) or to treatment (n=132). Treatment participants received a free wireless activity tracker and enrolled in the walking program, Walkadoo. Assessments were fully automated: activity tracker recorded primary outcomes (steps) without intervention by the participant or investigators. The two arms were compared on change in steps per day from baseline to follow-up (after 6 weeks of treatment) using a two-tailed independent samples t test. Results: Participants (N=265) were 66.0% (175/265) female with an average age of 39.9 years. Over half of the participants (142/265, 53.6%) were sedentary (<5000 steps/day) and 44.9% (119/265) were low to somewhat active (5000-9999 steps/day). The intervention group significantly increased their steps by 970 steps/day over control (P<.001), with treatment effects observed in sedentary (P=.04) and low-to-somewhat active (P=.004) participants alike. Conclusions: The program is effective in increasing daily steps. Participants benefited from the program regardless of their initial activity level. A tailored, adaptive approach using wireless activity trackers is realistically implementable and scalable. Trial Registration: Clinicaltrials.gov NCT02229409, https://clinicaltrials.gov/ct2/show/NCT02229409 (Archived by WebCite at http://www.webcitation.org/6eiWCvBYe) %M 26860434 %R 10.2196/jmir.5295 %U http://www.jmir.org/2016/2/e34/ %U https://doi.org/10.2196/jmir.5295 %U http://www.ncbi.nlm.nih.gov/pubmed/26860434 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 2 %P e30 %T Changes in Physical Activity Following a Genetic-Based Internet-Delivered Personalized Intervention: Randomized Controlled Trial (Food4Me) %A Marsaux,Cyril FM %A Celis-Morales,Carlos %A Livingstone,Katherine M %A Fallaize,Rosalind %A Kolossa,Silvia %A Hallmann,Jacqueline %A San-Cristobal,Rodrigo %A Navas-Carretero,Santiago %A O'Donovan,Clare B %A Woolhead,Clara %A Forster,Hannah %A Moschonis,George %A Lambrinou,Christina-Paulina %A Surwillo,Agnieszka %A Godlewska,Magdalena %A Hoonhout,Jettie %A Goris,Annelies %A Macready,Anna L %A Walsh,Marianne C %A Gibney,Eileen R %A Brennan,Lorraine %A Manios,Yannis %A Traczyk,Iwona %A Drevon,Christian A %A Lovegrove,Julie A %A Martinez,J Alfredo %A Daniel,Hannelore %A Gibney,Michael J %A Mathers,John C %A Saris,Wim HM %+ Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre + (MUMC+), PO Box 616, Maastricht, 6200 MD, Netherlands, 31 433881379, c.marsaux@maastrichtuniversity.nl %K FTO %K physical activity %K personalized intervention %K randomized controlled trial %K genetic testing %K disclosure %K behavior change %K Web based %D 2016 %7 5.2.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: There is evidence that physical activity (PA) can attenuate the influence of the fat mass- and obesity-associated (FTO) genotype on the risk to develop obesity. However, whether providing personalized information on FTO genotype leads to changes in PA is unknown. Objective: The purpose of this study was to determine if disclosing FTO risk had an impact on change in PA following a 6-month intervention. Methods: The single nucleotide polymorphism (SNP) rs9939609 in the FTO gene was genotyped in 1279 participants of the Food4Me study, a four-arm, Web-based randomized controlled trial (RCT) in 7 European countries on the effects of personalized advice on nutrition and PA. PA was measured objectively using a TracmorD accelerometer and was self-reported using the Baecke questionnaire at baseline and 6 months. Differences in baseline PA variables between risk (AA and AT genotypes) and nonrisk (TT genotype) carriers were tested using multiple linear regression. Impact of FTO risk disclosure on PA change at 6 months was assessed among participants with inadequate PA, by including an interaction term in the model: disclosure (yes/no) × FTO risk (yes/no). Results: At baseline, data on PA were available for 874 and 405 participants with the risk and nonrisk FTO genotypes, respectively. There were no significant differences in objectively measured or self-reported baseline PA between risk and nonrisk carriers. A total of 807 (72.05%) of the participants out of 1120 in the personalized groups were encouraged to increase PA at baseline. Knowledge of FTO risk had no impact on PA in either risk or nonrisk carriers after the 6-month intervention. Attrition was higher in nonrisk participants for whom genotype was disclosed (P=.01) compared with their at-risk counterparts. Conclusions: No association between baseline PA and FTO risk genotype was observed. There was no added benefit of disclosing FTO risk on changes in PA in this personalized intervention. Further RCT studies are warranted to confirm whether disclosure of nonrisk genetic test results has adverse effects on engagement in behavior change. Trial Registration: ClinicalTrials.gov NCT01530139; http://clinicaltrials.gov/show/NCT01530139 (Archived by WebCite at: http://www.webcitation.org/6XII1QwHz) %M 26851191 %R 10.2196/jmir.5198 %U http://www.jmir.org/2016/2/e30/ %U https://doi.org/10.2196/jmir.5198 %U http://www.ncbi.nlm.nih.gov/pubmed/26851191 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 2 %P e29 %T Effects of a Web-Based Computer-Tailored Game to Reduce Binge Drinking Among Dutch Adolescents: A Cluster Randomized Controlled Trial %A Jander,Astrid %A Crutzen,Rik %A Mercken,Liesbeth %A Candel,Math %A de Vries,Hein %+ School for Public Health and Primary Care CAPHRI, Department of Health Promotion, Maastricht University, PO Box 616, Maastricht, 6200 MD, Netherlands, 31 433884279, astrid.jander@maastrichtuniversity.nl %K adolescents %K alcohol drinking %K binge drinking %K cluster randomized controlled trial %K serious games %K computer tailoring %D 2016 %7 03.02.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Binge drinking among Dutch adolescents is among the highest in Europe. Few interventions so far have focused on adolescents aged 15 to 19 years. Because binge drinking increases significantly during those years, it is important to develop binge drinking prevention programs for this group. Web-based computer-tailored interventions can be an effective tool for reducing this behavior in adolescents. Embedding the computer-tailored intervention in a serious game may make it more attractive to adolescents. Objective: The aim was to assess whether a Web-based computer-tailored intervention is effective in reducing binge drinking in Dutch adolescents aged 15 to 19 years. Secondary outcomes were reduction in excessive drinking and overall consumption during the previous week. Personal characteristics associated with program adherence were also investigated. Methods: A cluster randomized controlled trial was conducted among 34 Dutch schools. Each school was randomized into either an experimental (n=1622) or a control (n=1027) condition. Baseline assessment took place in January and February 2014. At baseline, demographic variables and alcohol use were assessed. Follow-up assessment of alcohol use took place 4 months later (May and June 2014). After the baseline assessment, participants in the experimental condition started with the intervention consisting of a game about alcohol in which computer-tailored feedback regarding motivational characteristics was embedded. Participants in the control condition only received the baseline questionnaire. Both groups received the 4-month follow-up questionnaire. Effects of the intervention were assessed using logistic regression mixed models analyses for binge and excessive drinking and linear regression mixed models analyses for weekly consumption. Factors associated with intervention adherence in the experimental condition were explored by means of a linear regression model. Results: In total, 2649 adolescents participated in the baseline assessment. At follow-up, 824 (31.11%) adolescents returned. The intervention was effective in reducing binge drinking among adolescents aged 15 years (P=.03) and those aged 16 years when they participated in at least 2 intervention sessions (P=.04). Interaction effects between excessive drinking and educational level (P=.08) and between weekly consumption and age (P=.09) were found; however, in-depth analyses revealed no significant subgroup effects for both interaction effects. Additional analyses revealed that prolonged use of the intervention was associated with stronger effects for binge drinking. Yet, overall adherence to the intervention was low. Analyses revealed that being Protestant, female, younger, a nonbinge drinker, and having a higher educational background were associated with adherence. Conclusions: The intervention was effective for adolescents aged 15 and 16 years concerning binge drinking. Prevention messages may be more effective for those at the start of their drinking career, whereas other methods may be needed for those with a longer history of alcohol consumption. Despite using game elements, intervention completion was low. Trial Registration: Dutch Trial Register: NTR4048; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4048 (Archived by WebCite® at http://www.webcitation.org/6eSJD3FiY) %M 26842694 %R 10.2196/jmir.4708 %U http://www.jmir.org/2016/2/e29/ %U https://doi.org/10.2196/jmir.4708 %U http://www.ncbi.nlm.nih.gov/pubmed/26842694 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e11 %T Assessing the Usability of Web-Based Alcohol Education for Older Adults: A Feasibility Study %A Fink,Arlene %A Kwan,Lorna %A Osterweil,Dan %A Van Draanen,Jenna %A Cooke,Alexis %A Beck,John C %+ Arlene Fink Associates, 1562 Casale Road, Pacific Palisades, CA, 90272, United States, 1 3104544296, arlene.fink@gmail.com %K alcohol %K older adults %K elderly %K web-based %K education %K online alcohol education %D 2016 %7 01.02.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Older adults can experience unfavorable health effects from drinking at relatively low consumption levels because of age-related physiological changes and alcohol’s potentially adverse interactions with declining health, increased medication-use and diminishing functional status. At the same time, alcohol use in older adults may be protective against heart disease, stroke, and other disorders associated with aging. We developed “A Toast to Health in Later Life! Wise Drinking as We Age,” a web-based educational intervention to teach older adults to balance drinking risks and benefits. Objective: To examine the intervention’s feasibility in a sample of community-dwelling current drinkers ≥55 years of age and examine its effects on their quantity and frequency of alcohol use, adherence to standard drinking guidelines, and alcohol-related risks. Methods: Participants were recruited in person, by mail and by telephone between September and October 2014 from a community-based social services organization serving Los Angeles County. Once enrolled, participants were randomly assigned to the intervention or to a control group. The conceptual frameworks for the intervention were the Health Belief Model, models of adult learning, and the US Department of Health and Human Services guidelines for designing easy-to-use websites. The intervention’s content focuses on the relationship between drinking and its effects on older adults’ medical conditions, use of medications, and ability to perform daily activities. It also addresses quantity and frequency of alcohol use, drinking and driving and binge drinking. The control group did not receive any special intervention. Data on alcohol use and risks for both groups came from the online version of the Alcohol-Related Problems Survey and were collected at baseline and four weeks later. Data on usability were collected online from the intervention group immediately after it completed its review of the website. Results: The 49 intervention and 47 control participants did not differ at baseline in age, ethnicity, medication use, medical conditions, or alcohol use and both groups were mostly female, college-educated, and in good health. Of the intervention participants, 94% (46/49) had little or no difficulty using the website, with 67% (33/49) reporting that they will change the way they think about drinking because of their exposure to the education. At the 4-week follow-up, the intervention group reported drinking less (P=.02). No changes between groups were found in quantity and frequency, adherence to recommended guidelines, or risk status. Conclusions: Community-dwelling older adults are receptive to online alcohol education. To be most effective, the education should be included as a component of a larger effort consisting of screening and counseling preferably in a health care setting. %M 26832213 %R 10.2196/resprot.4545 %U http://www.researchprotocols.org/2016/1/e11/ %U https://doi.org/10.2196/resprot.4545 %U http://www.ncbi.nlm.nih.gov/pubmed/26832213 %0 Journal Article %@ 2291-9279 %I JMIR Publications Inc. %V 4 %N 1 %P e1 %T Behavioral Economics, Wearable Devices, and Cooperative Games: Results From a Population-Based Intervention to Increase Physical Activity %A van Mierlo,Trevor %A Hyatt,Douglas %A Ching,Andrew T %A Fournier,Rachel %A Dembo,Ron S %+ Evolution Health Systems Inc., 901 King Street West, Suite 400, Toronto, ON, M5V 3H5, Canada, 1 4166448476, tvanmierlo@evolutionhs.com %K behavioral economics, cooperative games, adherence, compliance, serious games, Superusers, health rewards, internet of things, wearable devices %D 2016 %7 28.01.2016 %9 Original Paper %J JMIR Serious Games %G English %X Background: Health care literature supports the development of accessible interventions that integrate behavioral economics, wearable devices, principles of evidence-based behavior change, and community support. However, there are limited real-world examples of large scale, population-based, member-driven reward platforms. Subsequently, a paucity of outcome data exists and health economic effects remain largely theoretical. To complicate matters, an emerging area of research is defining the role of Superusers, the small percentage of unusually engaged digital health participants who may influence other members. Objective: The objective of this preliminary study is to analyze descriptive data from GOODcoins, a self-guided, free-to-consumer engagement and rewards platform incentivizing walking, running and cycling. Registered members accessed the GOODcoins platform through PCs, tablets or mobile devices, and had the opportunity to sync wearables to track activity. Following registration, members were encouraged to join gamified group challenges and compare their progress with that of others. As members met challenge targets, they were rewarded with GOODcoins, which could be redeemed for planet- or people-friendly products. Methods: Outcome data were obtained from the GOODcoins custom SQL database. The reporting period was December 1, 2014 to May 1, 2015. Descriptive self-report data were analyzed using MySQL and MS Excel. Results: The study period includes data from 1298 users who were connected to an exercise tracking device. Females consisted of 52.6% (n=683) of the study population, 33.7% (n=438) were between the ages of 20-29, and 24.8% (n=322) were between the ages of 30-39. 77.5% (n=1006) of connected and active members met daily-recommended physical activity guidelines of 30 minutes, with a total daily average activity of 107 minutes (95% CI 90, 124). Of all connected and active users, 96.1% (n=1248) listed walking as their primary activity. For members who exchanged GOODcoins, the mean balance was 4,000 (95% CI 3850, 4150) at time of redemption, and 50.4% (n=61) of exchanges were for fitness or outdoor products, while 4.1% (n=5) were for food-related items. Participants were most likely to complete challenges when rewards were between 201-300 GOODcoins. Conclusions: The purpose of this study is to form a baseline for future research. Overall, results indicate that challenges and incentives may be effective for connected and active members, and may play a role in achieving daily-recommended activity guidelines. Registrants were typically younger, walking was the primary activity, and rewards were mainly exchanged for fitness or outdoor products. Remaining to be determined is whether members were already physically active at time of registration and are representative of healthy adherers, or were previously inactive and were incentivized to change their behavior. As challenges are gamified, there is an opportunity to investigate the role of superusers and healthy adherers, impacts on behavioral norms, and how cooperative games and incentives can be leveraged across stratified populations. Study limitations and future research agendas are discussed. %M 26821955 %R 10.2196/games.5358 %U http://games.jmir.org/2016/1/e1/ %U https://doi.org/10.2196/games.5358 %U http://www.ncbi.nlm.nih.gov/pubmed/26821955 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 1 %P e18 %T The Effect of Information Communication Technology Interventions on Reducing Social Isolation in the Elderly: A Systematic Review %A Chen,Yi-Ru Regina %A Schulz,Peter J %+ Hong Kong Baptist University, Department of Communication Studies, Hong Kong Baptist University, Kowloon Tong, , China (Hong Kong), 852 3411 5057, yrchen@hkbu.edu.hk %K social isolation %K elderly %K ICT intervention %D 2016 %7 28.01.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: The aging of the population is an inexorable change that challenges governments and societies in every developed country. Based on clinical and empirical data, social isolation is found to be prevalent among elderly people, and it has negative consequences on the elderly’s psychological and physical health. Targeting social isolation has become a focus area for policy and practice. Evidence indicates that contemporary information and communication technologies (ICT) have the potential to prevent or reduce the social isolation of elderly people via various mechanisms. Objective: This systematic review explored the effects of ICT interventions on reducing social isolation of the elderly. Methods: Relevant electronic databases (PsycINFO, PubMed, MEDLINE, EBSCO, SSCI, Communication Studies: a SAGE Full-Text Collection, Communication & Mass Media Complete, Association for Computing Machinery (ACM) Digital Library, and IEEE Xplore) were systematically searched using a unified strategy to identify quantitative and qualitative studies on the effectiveness of ICT-mediated social isolation interventions for elderly people published in English between 2002 and 2015. Narrative synthesis was performed to interpret the results of the identified studies, and their quality was also appraised. Results: Twenty-five publications were included in the review. Four of them were evaluated as rigorous research. Most studies measured the effectiveness of ICT by measuring specific dimensions rather than social isolation in general. ICT use was consistently found to affect social support, social connectedness, and social isolation in general positively. The results for loneliness were inconclusive. Even though most were positive, some studies found a nonsignificant or negative impact. More importantly, the positive effect of ICT use on social connectedness and social support seemed to be short-term and did not last for more than six months after the intervention. The results for self-esteem and control over one’s life were consistent but generally nonsignificant. ICT was found to alleviate the elderly’s social isolation through four mechanisms: connecting to the outside world, gaining social support, engaging in activities of interests, and boosting self-confidence. Conclusions: More well-designed studies that contain a minimum risk of research bias are needed to draw conclusions on the effectiveness of ICT interventions for elderly people in reducing their perceived social isolation as a multidimensional concept. The results of this review suggest that ICT could be an effective tool to tackle social isolation among the elderly. However, it is not suitable for every senior alike. Future research should identify who among elderly people can most benefit from ICT use in reducing social isolation. Research on other types of ICT (eg, mobile phone–based instant messaging apps) should be conducted to promote understanding and practice of ICT-based social-isolation interventions for elderly people. %M 26822073 %R 10.2196/jmir.4596 %U http://www.jmir.org/2016/1/e18/ %U https://doi.org/10.2196/jmir.4596 %U http://www.ncbi.nlm.nih.gov/pubmed/26822073 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 1 %P e21 %T Web-Based and Mobile Stress Management Intervention for Employees: A Randomized Controlled Trial %A Heber,Elena %A Lehr,Dirk %A Ebert,David Daniel %A Berking,Matthias %A Riper,Heleen %+ Leuphana University Lueneburg, Division of Online Health Training, Innovation Incubator, Scharnhorststrasse 1, Lueneburg, 21335, Germany, 49 4131 677 1708, heber@leuphana.de %K Internet %K randomized controlled trial %K work %K stress %K stress management %K mental health %D 2016 %7 27.01.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Work-related stress is highly prevalent among employees and is associated with adverse mental health consequences. Web-based interventions offer the opportunity to deliver effective solutions on a large scale; however, the evidence is limited and the results conflicting. Objective: This randomized controlled trial evaluated the efficacy of guided Web- and mobile-based stress management training for employees. Methods: A total of 264 employees with elevated symptoms of stress (Perceived Stress Scale-10, PSS-10≥22) were recruited from the general working population and randomly assigned to an Internet-based stress management intervention (iSMI) or waitlist control group. The intervention (GET.ON Stress) was based on Lazarus’s transactional model of stress, consisted of seven sessions, and applied both well-established problem solving and more recently developed emotion regulation strategies. Participants also had the opportunity to request automatic text messages on their mobile phone along with the iSMI. Participants received written feedback on every completed session from an e-coach. The primary outcome was perceived stress (PSS-10). Web-based self-report assessments for both groups were scheduled at baseline, 7 weeks, and 6 months. At 12 months, an extended follow-up was carried out for the iSMI group only. Results: An intention-to-treat analysis of covariance revealed significantly large effect differences between iSMI and waitlist control groups for perceived stress at posttest (F1,261=58.08, P<.001; Cohen’s d=0.83) and at the 6-month follow-up (F1,261=80.17, P<.001; Cohen’s d=1.02). The effects in the iSMI group were maintained at 12-month follow-up. Conclusions: This Web- and mobile-based intervention has proven effective in reducing stress in employees in the long term. Internet-based stress management interventions should be further pursued as a valuable alternative to face-to-face interventions. Trial Registration: German Clinical Trials Register (DRKS): 00004749; http://drks-neu.uniklinik-freiburg.de/ drks_web/setLocale_EN.do (Archived by WebCite at http://www.webcitation.org/6e8rl98nl) %M 26818683 %R 10.2196/jmir.5112 %U http://www.jmir.org/2016/1/e21/ %U https://doi.org/10.2196/jmir.5112 %U http://www.ncbi.nlm.nih.gov/pubmed/26818683 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 1 %P e19 %T Impact of a Mobile Phone Intervention to Reduce Sedentary Behavior in a Community Sample of Adults: A Quasi-Experimental Evaluation %A Kendzor,Darla E %A Shuval,Kerem %A Gabriel,Kelley Pettee %A Businelle,Michael S %A Ma,Ping %A High,Robin R %A Cuate,Erica L %A Poonawalla,Insiya B %A Rios,Debra M %A Demark-Wahnefried,Wendy %A Swartz,Michael D %A Wetter,David W %+ Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, 655 Research Parkway, Suite 400, Oklahoma City, OK, 73104, United States, 1 405 271 8001 ext 50478, Darla-Kendzor@ouhsc.edu %K sedentary lifestyle %K mobile phone %K African Americans %K physical activity %D 2016 %7 25.01.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Greater time spent sedentary is linked with increased risk of breast, colorectal, ovarian, endometrial, and prostate cancers. Given steadily increasing rates of mobile phone ownership, mobile phone interventions may have the potential to broadly influence sedentary behavior across settings. Objective: The purpose of this study was to examine the short-term impact of a mobile phone intervention that targeted sedentary time in a diverse community sample. Methods: Adults participated in a quasi-experimental evaluation of a mobile phone intervention designed to reduce sedentary time through prompts to interrupt periods of sitting. Participants carried mobile phones and wore accelerometers for 7 consecutive days. Intervention participants additionally received mobile phone prompts during self-reported sitting and information about the negative health impact of prolonged sedentariness. The study was conducted from December 2012 to November 2013 in Dallas, Texas. Linear mixed model regression analyses were conducted to evaluate the influence of the intervention on daily accelerometer-determined estimates of sedentary and active time. Results: Participants (N=215) were predominantly female (67.9%, 146/215) and nonwhite (black: 50.7%, 109/215; Latino: 12.1%, 26/215; other: 5.6%, 12/215). Analyses revealed that participants who received the mobile phone intervention had significantly fewer daily minutes of sedentary time (B=–22.09, P=.045) and more daily active minutes (B=23.01, P=.04) than control participants. Conclusions: A simple mobile phone intervention was associated with engaging in less sedentary time and more physical activity. Findings underscore the potential impact of mobile phone interventions to positively influence sedentary behavior and physical activity. %M 26810027 %R 10.2196/jmir.5137 %U http://www.jmir.org/2016/1/e19/ %U https://doi.org/10.2196/jmir.5137 %U http://www.ncbi.nlm.nih.gov/pubmed/26810027 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e14 %T A Web-Based Intervention to Encourage Walking (StepWise): Pilot Randomized Controlled Trial %A Hargreaves,Elaine Anne %A Mutrie,Nanette %A Fleming,Jade Dallas %+ School of Physical Education, Sport & Exercise Sciences, University of Otago, PO Box 56, Dunedin, 9054, New Zealand, 64 34798941, elaine.hargreaves@otago.ac.nz %K physical activity, behavior change strategies, pedometer, self-monitoring, step goal walking program %D 2016 %7 25.01.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Despite Internet-based interventions that incorporate pedometers with appropriate goal-setting processes and other theoretically-based behavior change strategies being proposed as a means of increasing walking behavior, few have incorporated all of these key features or assessed maintenance of behavior change. Objective: The objective of our study was to investigate the effect of a 12-week pedometer step goal walking program individually tailored to baseline step counts, combined with an interactive support website for step counts, health parameters and motivation over 12 and 24 weeks. Methods: Low active participants (mean [SD] 46.2 [11.2] years) were randomly assigned to the Stepwise (SW) intervention group (n=49) or a comparison (CP) group (n=48). SW received a pedometer, step goal walking program and access to the SW website (containing interactive self-monitoring and goal feedback tools, motivational messages and action and coping planning strategies). CP received a pedometer and locally available physical activity information. Step counts, BMI, resting heart rate, blood pressure and glucose, cholesterol and triglyceride levels, psychological well-being, perceived health, self-efficacy and self-determined motivation were measured at baseline, 12 and 24 weeks. Results: Linear mixed model analysis found that both groups’ step counts increased from baseline to week 12 (β = 11,002, CI 5739-16,266, P<.001) and 24 (β = 6810, CI 1190-12,431; P=.02). Group step counts were significantly different at week 24 with SW taking 8939 (CI 274-17604, P=.04) more steps compared to CP. Compared to baseline, both groups had improved triglyceride levels (0.14 mmol/L, CI -0.25 to -0.02, P=.02) at week 12, decreased diastolic blood pressure (4.22 mmHg, CI -6.73 to -1.72) at weeks 12 and 24 (3.17 mmHg, CI -5.55 to -0.78), improved positive (β = .21, CI 0.03-0.38, P=.02) and negative affect (β = -.15, CI -0.28 to -0.03, P=.02) at week 12, and perceived health at week 12 (β = 6.37, CI 2.10-10.65, P=.004) and 24 (β = 8.52, CI 3.98-13.06, P<.001). Total cholesterol increased at week 12 (0.26 mmol/L, CI 0.099-0.423, P=.006) and week 24 (0.38 mmol/L, CI 0.20-0.56, P<.001). Repeated measures ANOVA found motivation for walking improved from baseline with higher task self-efficacy (P<.001, η2 = .13) and autonomous motivation (P<.001, η2=.14) at weeks 12 and 24 and decreased controlled motivation (P=.004, η2=.08) at week 24. Conclusions: Both groups had similar improvements in step counts and physical and psychological health after 12 weeks but only the SW group successfully maintained the increased step-counts 24 weeks post-intervention. This suggests the step-goal based walking program combined with Internet-based behavior change tools were important for sustained behavior change. %M 26810251 %R 10.2196/resprot.4288 %U http://www.researchprotocols.org/2016/1/e14/ %U https://doi.org/10.2196/resprot.4288 %U http://www.ncbi.nlm.nih.gov/pubmed/26810251 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 4 %N 1 %P e10 %T Unpacking the Black Box: A Formative Research Approach to the Development of Theory-Driven, Evidence-Based, and Culturally Safe Text Messages in Mobile Health Interventions %A Maar,Marion A %A Yeates,Karen %A Toth,Zsolt %A Barron,Marcia %A Boesch,Lisa %A Hua-Stewart,Diane %A Liu,Peter %A Perkins,Nancy %A Sleeth,Jessica %A Wabano,Mary Jo %A Williamson,Pamela %A Tobe,Sheldon W %+ Faculty of Medicine, Northern Ontario School of Medicine, Laurentian University, 935 Ramsey Lake Road, Sudbury, ON, , Canada, 1 705 662 7233, mmaar@nosm.ca %K Aboriginal people %K behavioral change wheel %K cultural safety %K grounded theory %K mobile phone %K semiotics %K SMS %K Tanzania %K text messages %D 2016 %7 22.01.2016 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: Mobile-cellular subscriptions have increased steadily over the past decade. The accessibility of SMS messages over existing mobile networks is high and has almost universal availability even on older and unsophisticated mobile phones and in geographic settings where wireless coverage is weak. There is intensive exploration of this inexpensive mobile telecommunication technology to improve health services and promote behavior change among vulnerable populations. However, a neglected area of research is the documentation and critical analysis of the formative research process required in the development and refinement of effective SMS messages. Objective: The objective of this qualitative research study was to identify major factors that may impact on the effectiveness of evidence-based SMS messages designed to reduce health inequities in hypertension management in low resource settings, including Aboriginal populations in high-income countries and rural populations in low-income countries. Specifically, we were interested in uncovering the range of mediators that impact on appropriate message content transmission and, ultimately, on health behavior improvements in a range of these sociocultural settings. Methods: Collaborative qualitative research with Canadian Aboriginal and Tanzanian participants was conducted to deconstruct the content and transmission of evidence-based health information contained in SMS messages in the context of an international research project designed to address health inequalities in hypertension, and to develop a grounded theory of the major factors that mediate the effectiveness of this communication. We also examined the interrelationship of these mediators with the three essential conditions of the behavior system of the Behavioral Change Wheel model (capability, opportunity, and motivation) and cultural safety. Results: Four focus groups with a total of 45 participants were conducted. Our grounded theory research revealed how discrepancies develop between the evidence-based text message created by researchers and the message received by the recipient in mobile health interventions. These discrepancies were primarily generated by six mediators of meaning in SMS messages: (1) negative or non-affirming framing of advocacies, (2) fear- or stress-inducing content, (3) oppressive or authoritarian content, (4) incongruity with cultural and traditional practices, (5) disconnect with the reality of the social determinants of health and the diversity of cultures within a population, and (6) lack of clarity and/or practicality of content. These 6 mediators of meaning provide the basis for sound strategies for message development because they impact directly on the target populations’ capability, opportunity, and motivation for behavior change. Conclusions: The quality of text messages impacts significantly on the effectiveness of a mobile health intervention. Our research underscores the urgent need for interventions to incorporate and evaluate the quality of SMS messages and to examine the mediators of meaning within each targeted cultural and demographic group. Reporting on this aspect of mobile health intervention research will allow researchers to move away from the current black box of SMS text message development, thus improving the transparency of the process as well as the quality of the outcomes. %M 26800712 %R 10.2196/mhealth.4994 %U http://mhealth.jmir.org/2016/1/e10/ %U https://doi.org/10.2196/mhealth.4994 %U http://www.ncbi.nlm.nih.gov/pubmed/26800712 %0 Journal Article %@ 2368-7959 %I JMIR Publications Inc. %V 3 %N 1 %P e3 %T Usability Evaluation of a Mobile Monitoring System to Assess Symptoms After a Traumatic Injury: A Mixed-Methods Study %A Price,Matthew %A Sawyer,Tyler %A Harris,Madison %A Skalka,Christian %+ Center for Research on Emotion, Stress, and Technology, Department of Psychological Science, University of Vermont, Room 248, 2 Colchester Avenue, Burlington, VT, 05405, United States, 1 8026563801, matthew.price@uvm.edu %K mobile phone %K trauma %K posttraumatic stress disorder %K usability %D 2016 %7 11.01.2016 %9 Original Paper %J JMIR Mental Health %G English %X Background: Victims of trauma are at high risk for mental health conditions such as posttraumatic stress disorder and depression. Regular assessment of mental health symptoms in the post-trauma period is necessary to identify those at greatest risk and provide treatment. The multiple demands of the acute post-trauma period present numerous barriers to such assessments. Mobile apps are a method by which to overcome these barriers in order to regularly assess symptoms, identify those at risk, and connect patients to needed services. Objective: The current study conducted a usability evaluation of a system to monitor mental health symptoms after a trauma. The system was developed to promote ease of use and facilitate quick transmission of data. Methods: A sample of 21 adults with a history of trauma completed a standardized usability test in a laboratory setting followed by a qualitative interview. Results: Usability testing indicated that the app was easy to use and that patients were able to answer several questions in less than 1 minute (mean [SD] 29.37 [7.53]; range 15-57). Qualitative analyses suggested that feedback should be included in such an app and recommendations for the type of feedback were offered. Conclusions: The results of the current study indicate that a mobile app to monitor post-trauma mental health symptoms would be well received by victims. Personalized feedback to the user was identified as critical to promote the usability of the software. %M 26753673 %R 10.2196/mental.5023 %U http://mental.jmir.org/2016/1/e3/ %U https://doi.org/10.2196/mental.5023 %U http://www.ncbi.nlm.nih.gov/pubmed/26753673 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 1 %P e7 %T A Guided Online and Mobile Self-Help Program for Individuals With Eating Disorders: An Iterative Engagement and Usability Study %A Nitsch,Martina %A Dimopoulos,Christina N %A Flaschberger,Edith %A Saffran,Kristina %A Kruger,Jenna F %A Garlock,Lindsay %A Wilfley,Denise E %A Taylor,Craig B %A Jones,Megan %+ Ferdinand Porsche Distance Learning University of Applied Sciences, Lothringerstraße 4-8, Vienna, 1040, Austria, 43 1 505 77 78 ext 152, martina.nitsch@fernfh.ac.at %K usability study %K engagement %K adherence %K dropout %K digital health intervention %K online program %K self-help %K eating disorder %K mobile application %D 2016 %7 11.01.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Numerous digital health interventions have been developed for mental health promotion and intervention, including eating disorders. Efficacy of many interventions has been evaluated, yet knowledge about reasons for dropout and poor adherence is scarce. Most digital health intervention studies lack appropriate research design and methods to investigate individual engagement issues. User engagement and program usability are inextricably linked, making usability studies vital in understanding and improving engagement. Objective: The aim of this study was to explore engagement and corresponding usability issues of the Healthy Body Image Program—a guided online intervention for individuals with body image concerns or eating disorders. The secondary aim was to demonstrate the value of usability research in order to investigate engagement. Methods: We conducted an iterative usability study based on a mixed-methods approach, combining cognitive and semistructured interviews as well as questionnaires, prior to program launch. Two separate rounds of usability studies were completed, testing a total of 9 potential users. Thematic analysis and descriptive statistics were used to analyze the think-aloud tasks, interviews, and questionnaires. Results: Participants were satisfied with the overall usability of the program. The average usability score was 77.5/100 for the first test round and improved to 83.1/100 after applying modifications for the second iteration. The analysis of the qualitative data revealed five central themes: layout, navigation, content, support, and engagement conditions. The first three themes highlight usability aspects of the program, while the latter two highlight engagement issues. An easy-to-use format, clear wording, the nature of guidance, and opportunity for interactivity were important issues related to usability. The coach support, time investment, and severity of users’ symptoms, the program’s features and effectiveness, trust, anonymity, and affordability were relevant to engagement. Conclusions: This study identified salient usability and engagement features associated with participant motivation to use the Healthy Body Image Program and ultimately helped improve the program prior to its implementation. This research demonstrates that improvements in usability and engagement can be achieved by testing and adjusting intervention design and content prior to program launch. The results are consistent with related research and reinforce the need for further research to identify usage patterns and effective means for reducing dropout. Digital health research should include usability studies prior to efficacy trials to help create more user-friendly programs that have a higher likelihood of “real-world” adoption. %M 26753539 %R 10.2196/jmir.4972 %U http://www.jmir.org/2016/1/e7/ %U https://doi.org/10.2196/jmir.4972 %U http://www.ncbi.nlm.nih.gov/pubmed/26753539 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 4 %N 1 %P e3 %T Outcomes of a Mobile Health Coaching Platform: 12-Week Results of a Single-Arm Longitudinal Study %A Willey,Steven %A Walsh,James K %+ St. Luke's Hospital, 224 South Woods Mill Road, Chesterfield, MO, 63017, United States, 1 314 469 0033, stnfrd93@yahoo.com %K weight loss %K weight reduction program %K obesity %K aerobic exercise %K resistance training %K waist circumference %K oxygen consumption %D 2016 %7 08.01.2016 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: The number of mobile health coaching applications is expanding at a rapid rate. An application that uses a guiding intelligence to deliver an individualized structured program has the potential to provide a significant benefit. However, there are few studies of this approach that examine multiple clinical outcomes in a longitudinal manner. Objective: The objective of the study was to conduct a 12-week evaluation of participants using the YouPlus Health mobile coaching platform, specifically examining the effects on body weight, waist measurement, blood pressure, lipid profile, glycohemoglobin (A1C), and maximum volume of oxygen consumption (VO2 max). Methods: A quasi-experimental research design was used. This included a single-arm pre and post intervention assessment of outcomes. Participants underwent a 12-week intervention in which they received the entirety of the mobile health coaching program via an application on their mobile phones and were evaluated in the same physician’s office setting every two weeks. Data regarding app usage was continuously collected and maintained in a database. Results: 10 subjects were enrolled in and completed the pilot study. The mean weight loss was 13.5 lbs. which represented 7.3% of baseline (P=.005). Mean waist circumference was reduced by 7.2 cm or 6.6% of baseline (P=.005). Both systolic (SBP) and diastolic (DBP) blood pressure measures were significantly lower after 12 weeks of intervention. Mean SBP fell 18.6 mmHg (P=.005) and mean DBP declined 6.4 mmHg (P=.005). VO2 max increased by an average of 3.13 ml/kg/min from baseline to study end (P=.005). From baseline to end-of-study HDL levels increased significantly by 4.0 mg/dL (P=.04) Total cholesterol, LDL, triglycerides, and glycohemoglobin (A1C) trended in the desired direction but did not meet statistical significance. All of the participants in the study completed the necessary in-app tutorials and also completed the in-app questions and received feedback. Every individual completed the appropriate amount of program levels necessary to give the specifics of the program, and the mean weekly app open rate ranged from 5.1 to 18.4. Conclusions: Users of the YouPlus Health mobile coaching platform experienced significant reductions in body weight, waist circumference, and both systolic and diastolic blood pressures, while attaining significant increases in HDL and VO2 Max. %M 26747611 %R 10.2196/mhealth.4933 %U http://mhealth.jmir.org/2016/1/e3/ %U https://doi.org/10.2196/mhealth.4933 %U http://www.ncbi.nlm.nih.gov/pubmed/26747611 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 1 %P e6 %T The Effectiveness of Prompts to Promote Engagement With Digital Interventions: A Systematic Review %A Alkhaldi,Ghadah %A Hamilton,Fiona L %A Lau,Rosa %A Webster,Rosie %A Michie,Susan %A Murray,Elizabeth %+ eHealth Unit, Research Department of Primary Care and Population Health, University College London, Upper 3rd Floor Royal Free Hospital, Rowland Hill Street, London, NW3 2PF, United Kingdom, 44 020 7794050 ext 31399, Ghadah.alkhaldi.12@ucl.ac.uk %K systematic review %K adherence %K engagement %K prompts %K digital interventions %D 2016 %7 08.01.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital interventions have been effective in improving numerous health outcomes and health behaviors; furthermore, they are increasingly being used in different health care areas, including self-management of long-term conditions, mental health, and health promotion. The full potential of digital interventions is hindered by a lack of user engagement. There is an urgent need to develop effective strategies that can promote users’ engagement with digital interventions. One potential method is the use of technology-based reminders or prompts. Objective: To evaluate the effectiveness of technology-based strategies for promoting engagement with digital interventions. Methods: Cochrane Collaboration guidelines on systematic review methodology were followed. The search strategy was executed across 7 electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Web of Science, the Education Resources Information Center (ERIC), PsycINFO, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). Databases were searched from inception to September 13, 2013, with no language or publication type restrictions, using three concepts: randomized controlled trials, digital interventions, and engagement. Gray literature and reference lists of included studies were also searched. Titles and abstracts were independently screened by 2 authors, then the full texts of potentially eligible papers were obtained and double-screened. Data from eligible papers were extracted by one author and checked for accuracy by another author. Bias was assessed using the Cochrane risk of bias assessment tool. Narrative synthesis was performed on all included studies and, where appropriate, data were pooled using meta-analysis. All findings were reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results: A total of 14 studies were included in the review with 8774 participants. Of the 14 studies, 9 had sufficient data to be included in the meta-analyses. The meta-analyses suggested that technology-based strategies can potentially promote engagement compared to no strategy for dichotomous outcomes (relative risk [RR] 1.27, 95% CI 1.01-1.60, I2=71%), but due to considerable heterogeneity and the small sample sizes in most studies, this result should be treated with caution. No studies reported adverse or economic outcomes. Only one study with a small sample size compared different characteristics; the study found that strategies promoting new digital intervention content and those sent to users shortly after they started using the digital intervention were more likely to engage users. Conclusions: Overall, studies reported borderline positive effects of technology-based strategies on engagement compared to no strategy. However, the results have to be interpreted with caution. More research is needed to replicate findings and understand which characteristics of the strategies are effective in promoting engagement and how cost-effective they are. %M 26747176 %R 10.2196/jmir.4790 %U http://www.jmir.org/2016/1/e6/ %U https://doi.org/10.2196/jmir.4790 %U http://www.ncbi.nlm.nih.gov/pubmed/26747176 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e5 %T Combining Persuasive Technology With Behavioral Theory to Support Weight Maintenance Through a Mobile Phone App: Protocol for the MotiMate App %A Brindal,Emily %A Hendrie,Gilly A %A Freyne,Jill %+ CSIRO, Food and Nutrition, Gate 13 Kintore Ave, Adelaide, 5000, Australia, 61 883050633, emily.brindal@csiro.au %K app %K weight maintenance %K psychology %K coping %D 2016 %7 08.01.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: The prevalence of health-focused mobile phone apps available for download increases daily, with weight management apps being among the most proliferative. However, most lack theoretic grounding or evidence of efficacy. There is a significant body of literature which provides evidence for behaviors which are associated with successful weight loss maintenance. Behavioral theory also provides further insight regarding successful behavior change and maintenance. Objective: We aimed to apply this knowledge to the development of the functionality of an app targeting weight loss maintenance. Methods: We have subsequently undertaken the development of a persuasive and behavior targeting mobile app (MotiMate) to assist in maintenance of weight loss. MotiMate combines persuasive and behavior change theories in a practical targeted tool through its motivational messages, personalized feedback, and intelligent supportive tools to manage weight, food, exercise, mood and stress. Results: The development and trial of MotiMate received funding support in May 2014. All 88 volunteers started the trial by December 2014 and were in the process of completing their final visits when this paper was submitted (May 2015). Data analysis is currently underway. Conclusions: The paper has presented a scientifically informed mobile phone app to support weight loss maintenance. Further evaluation of its efficacy is in progress. Trial Registration: ANZCTR 12614000474651; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366120 (Archived by WebCite at http://www.webcitation.org/6eJeQiKxi). %M 26747725 %R 10.2196/resprot.4664 %U http://www.researchprotocols.org/2016/1/e5/ %U https://doi.org/10.2196/resprot.4664 %U http://www.ncbi.nlm.nih.gov/pubmed/26747725 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 1 %P e5 %T Text Messaging for Exercise Promotion in Older Adults From an Upper-Middle-Income Country: Randomized Controlled Trial %A Müller,Andre Matthias %A Khoo,Selina %A Morris,Tony %+ Sports Centre, University of Malaya, Jalan Universiti, Kuala Lumpur, 50603, Malaysia, 60 11 11556673, andrematthiasmueller@gmail.com %K exercise %K text message %K mobile phone %K older adults %K mHealth %K Asia %K health behavior %K behavior maintenance %K physical activity %K Malaysia %D 2016 %7 07.01.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Mobile technology to promote exercise is effective; however, most evidence is from studies of younger groups in high-income countries. Investigating if short message service (SMS) texting can affect exercise participation in older adults from an upper-middle-income country is important considering the proliferation of mobile phones in developing regions and the increased interest of older adults in using mobile phones. Objective: The main objective was to examine the short- and long-term effects of SMS text messaging on exercise frequency in older adults. Secondary objectives were to investigate how SMS text messages impact study participants’ exercise frequency and the effects of the intervention on secondary outcomes. Methods: The Malaysian Physical Activity for Health Study (myPAtHS) was a 24-week, 2-arm, parallel randomized controlled trial conducted in urban Malaysia. Participants were recruited via health talks in resident associations and religious facilities. Older Malaysians (aged 55-70 years) who used mobile phones and did not exercise regularly were eligible to participate in the study. Participants randomly allocated to the SMS texting arm received an exercise booklet and 5 weekly SMS text messages over 12 weeks. The content of the SMS text messages was derived from effective behavior change techniques. The non-SMS texting arm participants received only the exercise booklet. Home visits were conducted to collect outcome data: (1) exercise frequency at 12 and 24 weeks, (2) secondary outcome data (exercise self-efficacy, physical activity–related energy expenditure, sitting time, body mass index, grip and leg strength) at baseline and at 12 and 24 weeks. Intention-to-treat procedures were applied for data analysis. Semistructured interviews focusing primarily on the SMS text messages and their impact on exercise frequency were conducted at weeks 12 and 24. Results: In total, 43 participants were randomized into the SMS texting arm (n=22) and the non-SMS texting arm (n=21). Study-unrelated injuries forced 4 participants to discontinue after a few weeks (they were not included in any analyses). Overall retention was 86% (37/43). After 12 weeks, SMS texting arm participants exercised significantly more than non-SMS texting arm participants (mean difference 1.21 times, bias-corrected and accelerated bootstrap [BCa] 95% CI 0.18-2.24). Interview analysis revealed that the SMS text messages positively influenced SMS texting arm participants who experienced exercise barriers. They described the SMS text messages as being encouraging, a push, and a reminder. After 24 weeks, there was no significant difference between the research arms (mean difference 0.74, BCa 95% CI –0.30 to 1.76). There were no significant effects for secondary outcomes. Conclusions: This study provides evidence that SMS text messaging is effective in promoting exercise in older adults from an upper-middle-income country. Although the effects were not maintained when SMS text messaging ceased, the results are promising and warrant more research on behavioral mobile health interventions in other regions. Trial Registration: Clinicaltrials.gov NCT02123342; http://clinicaltrials.gov/ct2/show/NCT02123342 (Archived by WebCite at http://www.webcitation.org/6eGSsu2EI). %M 26742999 %R 10.2196/jmir.5235 %U http://www.jmir.org/2016/1/e5/ %U https://doi.org/10.2196/jmir.5235 %U http://www.ncbi.nlm.nih.gov/pubmed/26742999 %0 Journal Article %@ 2368-7959 %I JMIR Publications Inc. %V 3 %N 1 %P e1 %T Web-Based Cognitive Behavioral Relapse Prevention Program With Tailored Feedback for People With Methamphetamine and Other Drug Use Problems: Development and Usability Study %A Takano,Ayumi %A Miyamoto,Yuki %A Kawakami,Norito %A Matsumoto,Toshihiko %+ Graduate School of Medicine, Department of Psychiatric Nursing, The University of Tokyo, 7-3-1 Hongo,, Bunkyo-ku,, Tokyo, 113-0033, Japan, 81 3 5841 3522, ayumi-takano@umin.ac.jp %K web-based %K drug dependence %K relapse prevention %K cognitive behavioral therapy %K motivational interviewing %K self-monitoring %K Internet %D 2016 %7 06.01.2016 %9 Original Paper %J JMIR Mental Health %G English %X Background: Although drug abuse has been a serious public health concern, there have been problems with implementation of treatment for drug users in Japan because of poor accessibility to treatment, concerns about stigma and confidentiality, and costs. Therapeutic interventions using the Internet and computer technologies could improve this situation and provide more feasible and acceptable approaches. Objective: The objective of the study was to show how we developed a pilot version of a new Web-based cognitive behavioral relapse prevention program with tailored feedback to assist people with drug problems and assessed its acceptance and usability. Methods: We developed the pilot program based on existing face-to-face relapse prevention approaches using an open source Web application to build an e-learning website, including relapse prevention sessions with videos, exercises, a diary function, and self-monitoring. When users submitted exercise answers and their diary, researchers provided them with personalized feedback comments using motivational interviewing skills. People diagnosed with drug dependence were recruited in this pilot study from a psychiatric outpatient ward and nonprofit rehabilitation facilities and usability was evaluated using Internet questionnaires. Overall, website usability was assessed by the Web Usability Scale. The adequacy of procedures in the program, ease of use, helpfulness of content, and adverse effects, for example, drug craving, mental distress, were assessed by original structured questionnaires and descriptive form questions. Results: In total, 10 people participated in the study and completed the baseline assessment, 60% completed all relapse prevention sessions within the expected period. The time needed to complete one session was about 60 minutes and most of the participants took 2 days to complete the session. Overall website usability was good, with reasonable scores on subscales of the Web Usability Scale. The participants felt that the relapse prevention sessions were easy to use and helpful, but that the length of the videos was too long. The participant who until recently used drugs was satisfied with the self-monitoring, but others that had already maintained abstinence for more than a year felt this activity was unhelpful and were bored tracking and recording information on daily drug use. Feedback comments from researchers enhanced participants’ motivation and further insight into the disease. Serious adverse effects caused by the intervention were not observed. Some possible improvements to the program were suggested. Conclusions: The Web-based relapse prevention program was easy to use and acceptable to drug users in this study. This program will be helpful for drug users who do not receive behavioral therapy. After the pilot program is revised, further large-scale research is needed to assess its efficacy among drug users who have recently used drugs. %M 26740264 %R 10.2196/mental.4875 %U http://mental.jmir.org/2016/1/e1/ %U https://doi.org/10.2196/mental.4875 %U http://www.ncbi.nlm.nih.gov/pubmed/26740264 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 12 %P e291 %T Feasibility and Quit Rates of the Tobacco Status Project: A Facebook Smoking Cessation Intervention for Young Adults %A Ramo,Danielle E %A Thrul,Johannes %A Chavez,Kathryn %A Delucchi,Kevin L %A Prochaska,Judith J %+ Department of Psychiatry, University of California, San Francisco, 401 Parnassus Avenue, Box TRC 0984, San Francisco, CA, 94143, United States, 1 4154767695, danielle.ramo@ucsf.edu %K smoking cessation %K Facebook %K social media %K young adults %D 2015 %7 31.12.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Young adult smokers are a challenging group to engage in smoking cessation interventions. With wide reach and engagement among users, Facebook offers opportunity to engage young people in socially supportive communities for quitting smoking and sustaining abstinence. Objective: We developed and tested initial efficacy, engagement, and acceptability of the Tobacco Status Project, a smoking cessation intervention for young adults delivered within Facebook. Methods: The intervention was based on the US Public Health Service Clinical Practice Guidelines and the Transtheoretical Model and enrolled participants into study-run 3-month secret Facebook groups matched on readiness to quit smoking. Cigarette smokers (N=79) aged 18-25, who used Facebook on most days, were recruited via Facebook. All participants received the intervention and were randomized to one of three monetary incentive groups tied to engagement (commenting in groups). Assessments were completed at baseline, 3-, 6-, and 12-months follow-up. Analyses examined retention, smoking outcomes over 12 months (7-day point prevalence abstinence, ≥50% reduction in cigarettes smoked, quit attempts and strategies used, readiness to quit), engagement, and satisfaction with the intervention. Results: Retention was 82% (65/79) at 6 months and 72% (57/79) at 12 months. From baseline to 12-months follow-up, there was a significant increase in the proportion prepared to quit (10/79, 13%; 36/79, 46%, P<.001). Over a third (28/79, 35%) reduced their cigarette consumption by 50% or greater, and 66% (52/79) made at least one 24-hour quit attempt during the study. In an intent-to-treat analysis, 13% (10/79) self-reported 7-day abstinence (6/79, 8% verified biochemically) at 12-months follow-up. In their quit attempts, 11% (9/79) used a nicotine replacement therapy approved by the Food and Drug Administration, while 18% (14/79) used an electronic nicotine delivery system to quit (eg, electronic cigarette). A majority (48/79, 61%) commented on at least one Facebook post, with more commenting among those with biochemically verified abstinence at 3 months (P=.036) and those randomized to receive a personal monetary incentive (P=.015). Over a third of participants (28/79, 35%) reported reading most or all of the Facebook posts. Highest acceptability ratings of the intervention were for post ease (57/79, 72%) and thinking about what they read (52/79, 66%); 71% (56/79) recommended the program to others. Only 5 participants attended the optional cognitive-behavioral counseling sessions, though their attendance was high (6/7 sessions overall) and the sessions were rated as easy to understand, useful, and helpful (all 90-100% agreed). Conclusions: A Facebook quit smoking intervention is attractive and feasible to deliver, and early efficacy data are encouraging. However, the 1.5-fold greater use of electronic cigarettes over nicotine replacement products for quitting is concerning. %M 26721211 %R 10.2196/jmir.5209 %U http://www.jmir.org/2015/12/e291/ %U https://doi.org/10.2196/jmir.5209 %U http://www.ncbi.nlm.nih.gov/pubmed/26721211 %0 Journal Article %@ 2369-1999 %I JMIR Publications Inc. %V 1 %N 2 %P e13 %T Needs and Preferences of Partners of Cancer Patients Regarding a Web-Based Psychological Intervention: A Qualitative Study %A Köhle,Nadine %A Drossaert,Constance HC %A Oosterik,Suzan %A Schreurs,Karlein MG %A Hagedoorn,Mariët %A van Uden-Kraan,Cornelia F %A Verdonck-de Leeuw,Irma M %A Bohlmeijer,Ernst T %+ University of Twente, Department of Psychology, Health & Technology, P.O. Box 217, Enschede, 7500 AE, Netherlands, 31 053 489 2092, n.kohle@utwente.nl %K cancer %K oncology %K partner %K needs %K web-based interventions %K interventions %D 2015 %7 29.12.2015 %9 Original Paper %J JMIR Cancer %G English %X Background: Evidence-based, easily accessible, supportive interventions for partners of cancer patients are limited, despite the fact that they often suffer from diminished emotional, social, physical, and relational functioning. To develop a new intervention that will fit their demands, it is important to consult potential users. Objective: To examine partners’ interest in a Web-based psychological intervention and to identify their needs and wishes regarding such an intervention. Methods: Semistructured interviews were conducted with 16 partners of cancer patients, who varied in terms of age, gender, education, employment, type, and stage of disease. Partners were asked (1) whether they would use a psychological Web-based intervention and which preconditions (maximum time, structure, participate alone or with their partner) it should meet; (2) which functionalities (information, peer support, online psychological counseling) the intervention should contain; and (3) which topics (eg, taking care of oneself) should be addressed. Data were coded by 2 coders independently. Results: The need for a Web-based intervention varied. Arguments for being interested in a Web-based intervention included the need for acknowledgement; the need for someone they could talk to; and the need for information, tips, and support. Based on their experiences as a partner of a cancer patient, participants would prefer an intervention that is not too time-consuming (about 1-2 hours a week) and which is based on a “step-by-step” approach, meaning that the content of the intervention should match the stage of their partner’s disease. Also, they would prefer a positive approach, which means that the intervention should be a source of hope and energy. Most participants stated that they would prefer to participate without their ill spouse, because they do not want to burden their partners with their own problems. An intervention should contain information and optional peer support. Participants’ opinions about online psychological counseling in the intervention were divided. Arguments for online psychological counseling were that a professional could check on them and they were able to ask questions. Arguments against online counseling were that partners were not in need for guidance or they had enough support from usual care. Topics with the highest priority were “coping with feelings and emotions,” “should I or shouldn’t I spare my partner?,” “communicating with each other,” “asking for help and refusing help,” and “moving on with life after cancer treatment.” Furthermore, participants suggested additional topics of “dare to enjoy” and “acceptance of the patient’s disease.” Conclusions: A Web-based intervention can be a valuable addition to existing support initiatives for partners of cancer patients. This study provides important information about the content and form of such an intervention. Flexibility and a positive approach seem to be the most important features. %M 28410157 %R 10.2196/cancer.4631 %U http://cancer.jmir.org/2015/2/e13/ %U https://doi.org/10.2196/cancer.4631 %U http://www.ncbi.nlm.nih.gov/pubmed/28410157 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 3 %N 4 %P e104 %T The Most Popular Smartphone Apps for Weight Loss: A Quality Assessment %A Chen,Juliana %A Cade,Janet E %A Allman-Farinelli,Margaret %+ School of Molecular Bioscience, Charles Perkins Centre, University of Sydney, Johns Hopkins Dr, Camperdown, 2050, Australia, 61 2 9036 7045, margaret.allman-farinelli@sydney.edu.au %K behavior change techniques %K evaluation %K obesity %K quality %K smartphone apps %K weight management %D 2015 %7 16.12.2015 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: Advancements in mobile phone technology have led to the development of smartphones with the capability to run apps. The availability of a plethora of health- and fitness-related smartphone apps has the potential, both on a clinical and public health level, to facilitate healthy behavior change and weight management. However, current top-rated apps in this area have not been extensively evaluated in terms of scientific quality and behavioral theory evidence base. Objective: The purpose of this study was to evaluate the quality of the most popular dietary weight-loss smartphone apps on the commercial market using comprehensive quality assessment criteria, and to quantify the behavior change techniques (BCTs) incorporated. Methods: The top 200-rated Health & Fitness category apps from the free and paid sections of Google Play and iTunes App Store in Australia (n=800) were screened in August 2014. To be included in further analysis, an app had to focus on weight management, include a facility to record diet intake (self-monitoring), and be in English. One researcher downloaded and used the eligible apps thoroughly for 5 days and assessed the apps against quality assessment criteria which included the following domains: accountability, scientific coverage and content accuracy of information relevant to weight management, technology-enhanced features, usability, and incorporation of BCTs. For inter-rater reliability purposes, a second assessor provided ratings on 30% of the apps. The accuracy of app energy intake calculations was further investigated by comparison with results from a 3-day weighed food record (WFR). Results: Across the eligible apps reviewed (n=28), only 1 app (4%) received full marks for accountability. Overall, apps included an average of 5.1 (SD 2.3) out of 14 technology-enhanced features, and received a mean score of 13.5 (SD 3.7) out of 20 for usability. The majority of apps provided estimated energy requirements (24/28, 86%) and used a food database to calculate energy intake (21/28, 75%). When compared against the WFR, the mean absolute energy difference of apps which featured energy intake calculations (23/28, 82%) was 127 kJ (95% CI -45 to 299). An average of 6.3 (SD 3.7) of 26 BCTs were included. Conclusions: Overall, the most popular commercial apps for weight management are suboptimal in quality, given the inadequate scientific coverage and accuracy of weight-related information, and the relative absence of BCTs across the apps reviewed. With the limited regulatory oversight around the quality of these types of apps, this evaluation provides clinicians and consumers an informed view of the highest-quality apps in the current popular app pool appropriate for recommendation and uptake. Further research is necessary to assess the effectiveness of apps for weight management. %M 26678569 %R 10.2196/mhealth.4334 %U http://mhealth.jmir.org/2015/4/e104/ %U https://doi.org/10.2196/mhealth.4334 %U http://www.ncbi.nlm.nih.gov/pubmed/26678569 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 3 %N 4 %P e97 %T Web-Based and Mobile Delivery of an Episodic Future Thinking Intervention for Overweight and Obese Families: A Feasibility Study %A Sze,Yan Yan %A Daniel,Tinuke Oluyomi %A Kilanowski,Colleen K %A Collins,R Lorraine %A Epstein,Leonard H %+ Department of Pediatrics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Farber Hall, Room G56, 3435 Main Street, Building #26, Buffalo, NY, , United States, 1 716 829 3400, lhnet@buffalo.edu %K obesity %K ecological momentary intervention %K episodic future thinking %K Web-based %K health behavior %D 2015 %7 16.12.2015 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: The bias toward immediate gratification is associated with maladaptive eating behaviors and has been cross-sectionally and prospectively related to obesity. Engaging in episodic future thinking, which involves mental self-projection to pre-experience future events, reduces this bias and energy intake in overweight/obese adults and children. To examine how episodic future thinking can be incorporated into clinical interventions, a Web-based system was created to provide training for adults and children in their everyday lives. Objective: Our study examined the technical feasibility, usability, and acceptability of a Web-based system that is accessible by mobile devices and adapts episodic future thinking for delivery in family-based obesity interventions. Methods: We recruited 20 parent-child dyads (N=40) from the surrounding community and randomized to episodic future thinking versus a nutritional information thinking control to test the feasibility of a 4-week Web-based intervention. Parents were 44.1 (SD 7.8) years of age with BMI of 34.2 (SD 6.8) kg/m2. Children were 11.0 (SD 1.3) years of age with BMI percentile of 96.0 (SD 1.8). Families met weekly with a case manager for 4 weeks and used the system daily. Adherence was collected through the Web-based system, and perceived acceptance of the Web-based system was assessed postintervention. Measurements of body composition and dietary intake were collected at baseline and after the 4 weeks of intervention. Results: All 20 families completed the intervention and attended all sessions. Results showed parents and children had high adherence to the Web-based system and perceived it to be easy to use, useful, and helpful. No differences between conditions were found in adherence for parents (P=.65) or children (P=.27). In addition, results suggest that basic nutrition information along with episodic future thinking delivered through our Web-based system may reduce energy intake and weight. Conclusions: We showed that our Web-based system is an accepted technology and a feasible utility. Furthermore, results provide initial evidence that our system can be incorporated into family-based treatments targeting behaviors related to weight control. These results show promising utility in using our Web-based system in interventions. %M 26678959 %R 10.2196/mhealth.4603 %U http://mhealth.jmir.org/2015/4/e97/ %U https://doi.org/10.2196/mhealth.4603 %U http://www.ncbi.nlm.nih.gov/pubmed/26678959 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 3 %N 4 %P e105 %T A Text-Messaging and Pedometer Program to Promote Physical Activity in People at High Risk of Type 2 Diabetes: The Development of the PROPELS Follow-On Support Program %A Morton,Katie %A Sutton,Stephen %A Hardeman,Wendy %A Troughton,Jacqui %A Yates,Tom %A Griffin,Simon %A Davies,Melanie %A Khunti,Kamlesh %A Eborall,Helen %+ Social Science Applied to Healthcare Improvement Research Group, Department of Health Sciences, University of Leicester, 22-28 Princess Road West, Leicester, , United Kingdom, 44 116 252 5400, hce3@le.ac.uk %K physical activity %K mHealth %K text messaging %K pedometer %K tailoring %K type 2 diabetes %K intervention development %D 2015 %7 15.12.2015 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: Mobile technologies for health (mHealth) represent a promising strategy for reducing type 2 diabetes (T2DM) risk. The PROPELS trial investigates whether structured group-based education alone or supplemented with a follow-on support program combining self-monitoring with pedometers and tailored text-messaging is effective in promoting and maintaining physical activity among people at high risk of T2DM. Objective: This paper describes the iterative development of the PROPELS follow-on support program and presents evidence on its acceptability and feasibility. Methods: We used a modified mHealth development framework with four phases: (1) conceptualization of the follow-on support program using theory and evidence, (2) formative research including focus groups (n=15, ages 39-79 years), (3) pre-testing focus groups using a think aloud protocol (n=20, ages 52-78 years), and (4) piloting (n=11). Analysis was informed by the constant comparative approach, with findings from each phase informing subsequent phases. Results: The first three phases informed the structure, nature, and content of the follow-on support program, including the frequency of text messages, the need for tailored content and two-way interaction, the importance of motivational messages based on encouragement and reinforcement of affective benefits (eg, enjoyment) with minimal messages about weight and T2DM risk, and the need for appropriate language. The refined program is personalized and tailored to the individual’s perceived confidence, previous activity levels, and physical activity goals. The pilot phase indicated that the program appeared to fit well with everyday routines and was easy to use by older adults. Conclusions: We developed a feasible and innovative text messaging and pedometer program based on evidence and behavior change theory and grounded in the experiences, views, and needs of people at high diabetes risk. A large scale trial is testing the effectiveness of this 4-year program over and above structured group education alone. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 83465245; http://www.controlled-trials.com/ISRCTN83465245/83465245 (Archived by WebCite at http://www.webcitation.org/6dfSmrVAe) %M 26678750 %R 10.2196/mhealth.5026 %U http://mhealth.jmir.org/2015/4/e105/ %U https://doi.org/10.2196/mhealth.5026 %U http://www.ncbi.nlm.nih.gov/pubmed/26678750 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 12 %P e278 %T Preventing Alcohol Abuse Through Social Networking Sites: A First Assessment of a Two-Year Ecological Approach %A Flaudias,Valentin %A de Chazeron,Ingrid %A Zerhouni,Oulmann %A Boudesseul,Jordane %A Begue,Laurent %A Bouthier,Renaud %A Lévrier,Christel %A Llorca,Pierre Michel %A Brousse,Georges %+ CHU Clermont-Ferrand, Pôle Psychiatrie B, 58 Rue Montalembert, Clermont-Ferrand, F-63000, France, 33 473752072, vflaudias@chu-clermontferrand.fr %K social networking %K primary prevention %K alcohol consumption %K students %D 2015 %7 10.12.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Prevention strategies to reduce alcohol use/consumption among young people are crucial to reducing alcohol-related deaths and preventing disease. This paper focuses on the effectiveness of a social networking site (SNS) alcohol prevention program targeted toward young people. Objective: We hypothesized that the program would diminish the relation made by participants between alcohol and festive moments, and would result in a reduction of their declared consumption of alcohol at festive moments during the program. We also explored the interaction with the prevention program that was the most efficient. Methods: The prevention program took the form of 3 lotteries over 2 years. The participants periodically received prevention messages, particularly on alcohol and festive moments (eg, videos on Facebook and short message service [SMS] text messages on their mobile phones). For the 3 periods, the participants had to answer questions exploring the level of their belief that alcohol consumption and festive moments are highly associated. A control group that did not participate in the prevention program was asked the same questions over the same number of days for the first 2 periods. During the second period, the participants were asked to answer questions about their alcohol consumption during parties. During the third period, we explored the interaction with the prevention program on the reduction of their belief that alcohol consumption and festive moments are associated. Results: A total of 651 participants (age: mean 22.24, SD 4.10 years; women: n=430) during the first period, 301 participants (age: mean 21.27, SD 3.07 years; women n=199) during the second period, and 305 (age: mean 22.41, SD 4.65 years; women: n=190) during the third period correctly completed the survey. For the control group, 69 students completed the survey during the first period (age: mean 18.93, SD 1.14 years; women: n=59) and 50 during the second (age: mean 20.78, SD 1.94 years; women: n=45). We observed a significant reduction in the association of alcohol with festive moments in the participants over the 2 years (period 1: z=–4.80, P<.001; period 2: z=–2.11, P=.04; period 3: z=–2.30; P=.02), but not in the controls. We also observed a reduction in the number of glasses consumed during festive moments for the participants (z=–2.36, P=.02), but not for the controls during the second period. The third period showed that only the number of days since registration in the program had an impact on the reduction of the association of festive moments and alcohol consumption (t21=3.186, P=.005). Conclusions: The findings of this study suggest that the SNS prevention program is promising in preventing the association of alcohol with festive moments and, more generally, in impacting social norms. %M 26681577 %R 10.2196/jmir.4233 %U http://www.jmir.org/2015/12/e278/ %U https://doi.org/10.2196/jmir.4233 %U http://www.ncbi.nlm.nih.gov/pubmed/26681577 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 12 %P e274 %T An Online Health Prevention Intervention for Youth with Addicted or Mentally Ill Parents: Experiences and Perspectives of Participants and Providers from a Randomized Controlled Trial %A Woolderink,Marla %A Bindels,Jill APM %A Evers,Silvia MAA %A Paulus,Aggie TG %A van Asselt,Antoinette DI %A van Schayck,Onno CP %+ Clinical Epidemiology and Technology Assessment, Maastricht University Medical Center, Oxfordlaan 10, Maastricht, PO BOX 5800, 6202 AZ, Netherlands, 31 0031 043 3875, m.woolderink@maastrichtuniversity.nl %K online-delivered course %K process assessment %K qualitative research %K mental health %K prevention %K adolescents %D 2015 %7 02.12.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Mental illnesses affect many people around the world, either directly or indirectly. Families of persons suffering from mental illness or addiction suffer too, especially their children. In the Netherlands, 864,000 parents meet the diagnostic criteria for a mental illness or addiction. Evidence shows that offspring of mentally ill or addicted parents are at risk for developing mental disorders or illnesses themselves. The Kopstoring course is an online 8-week group course with supervision by 2 trained psychologists or social workers, aimed to prevent behavioral and psychological problems for children (aged 16 to 25 years) of parents with mental health problems or addictions. The course addresses themes such as roles in the family and mastery skills. An online randomized controlled trial (RCT) was conducted to assess the effectiveness of the Kopstoring course. Objective: The aim was to gain knowledge about expectations, experiences, and perspectives of participants and providers of the online Kopstoring course. Methods: A process evaluation was performed to evaluate the online delivery of Kopstoring and the experiences and perspectives of participants and providers of Kopstoring. Interviews were performed with members from both groups. Participants were drawn from a sample from the Kopstoring RCT. Results: Thirteen participants and 4 providers were interviewed. Five main themes emerged from these interviews: background, the requirements for the intervention, experience with the intervention, technical aspects, and research aspects. Overall, participants and providers found the intervention to be valuable because it was online; therefore, protecting their anonymity was considered a key component. Most barriers existed in the technical sphere. Additional barriers existed with conducting the RCT, namely gathering informed consent and gathering parental consent in the case of minors. Conclusions: This study provides valuable insight into participants’ and providers’ experiences and expectations with the online preventive intervention Kopstoring. It also sheds light on the process of the online provision of Kopstoring and the accompanying RCT. The findings of this study may partly explain dropout rates when delivering online interventions. The change in the (financial) structure of the youth mental health care system in the Netherlands has financial implications for the delivery of prevention programs for youth. Lastly, there are few RCTs that assess the effectiveness and cost-effectiveness of online prevention programs in the field of (youth) mental health care and not many process evaluations of these programs exist. This hampers a good comparison between online interventions and the expectations and experiences of the participants and providers. Trial Registration: Nederlands Trial Register: NTR1982; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1982 (Archived by WebCite® at http://www.webcitation.org/6d8xYDQbB) %M 26633244 %R 10.2196/jmir.4817 %U http://www.jmir.org/2015/12/e274/ %U https://doi.org/10.2196/jmir.4817 %U http://www.ncbi.nlm.nih.gov/pubmed/26633244 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 11 %P e267 %T The Impact of an eHealth Portal on Health Care Professionals’ Interaction with Patients: Qualitative Study %A Das,Anita %A Faxvaag,Arild %A Svanæs,Dag %+ Department of Neuroscience, Faculty of Medicine, Norwegian University of Science and Technology, Medisinsk Teknisk Forskningssenter, Trondheim, 7491, Norway, 47 97599434, anita.das@ntnu.no %K bariatric surgery %K online communication %K eHealth %K patient %K health care %K Web 2.0 %D 2015 %7 24.11.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: People who undergo weight loss surgery require a comprehensive treatment program to achieve successful outcomes. eHealth solutions, such as secure online portals, create new opportunities for improved health care delivery and care, but depend on the organizational delivery systems and on the health care professionals providing it. So far, these have received limited attention and the overall adoption of eHealth solutions remains low. In this study, a secure eHealth portal was implemented in a bariatric surgery clinic and offered to their patients. During the study period of 6 months, 60 patients and 5 health care professionals had access. The portal included patient information, self-management tools, and communication features for online dialog with peers and health care providers at the bariatric surgery clinic. Objective: The aim of this study was to characterize and assess the impact of an eHealth portal on health care professionals’ interaction with patients in bariatric surgery. Methods: This qualitative case study involved a field study consisting of contextual interviews at the clinic involving observing and speaking with personnel in their actual work environment. Semi-structured in-depth interviews were conducted with health care professionals who interacted with patients through the portal. Analysis of the collected material was done inductively using thematic analysis. Results: The analysis revealed two main dimensions of using an eHealth portal in bariatric surgery: the transparency it represents and the responsibility that follows by providing it. The professionals reported the eHealth portal as (1) a source of information, (2) a gateway to approach and facilitate the patients, (3) a medium for irrevocable postings, (4) a channel that exposes responsibility and competence, and (5) a tool in the clinic. Conclusions: By providing an eHealth portal to patients in a bariatric surgery program, health care professionals can observe patients’ writings and revelations thereby capturing patient challenges and acting and implementing measures. Interacting with patients through the portal can prevent dropouts and deterioration of patients’ health. However, professionals report on organizational challenges and personal constraints related to communicating with patients in writing online. Further development of guidelines and education of health care professionals about how to handle, prioritize, communicate, and facilitate patients online is required in addition to increased attention to the organizational infrastructures and incentives for enabling such solutions in health care. %M 26601678 %R 10.2196/jmir.4950 %U http://www.jmir.org/2015/11/e267/ %U https://doi.org/10.2196/jmir.4950 %U http://www.ncbi.nlm.nih.gov/pubmed/26601678 %0 Journal Article %@ 2369-1999 %I JMIR Publications Inc. %V 1 %N 2 %P e12 %T Feasibility and Preliminary Efficacy of an Online Intervention to Increase Physical Activity in Nova Scotian Cancer Survivors: A Randomized Controlled Trial %A Forbes,Cynthia C %A Blanchard,Chris M %A Mummery,W Kerry %A Courneya,Kerry S %+ University of Alberta, Van Vliet Complex, University Hall, Edmonton, AB, , Canada, 1 780 492 2829, kerry.courneya@ualberta.ca %K Web-based %K survivorship %K home-based %K exercise %K efficacy %K feasibility %D 2015 %7 23.11.2015 %9 Original Paper %J JMIR Cancer %G English %X Background: Physical activity (PA) behavior change interventions among cancer survivors have used face-to-face, telephone, email, and print-based methods. However, computer-tailored, Internet-delivered programs may be a more viable option to achieve PA behavior change. Objective: The objective of this study is to test the feasibility and preliminary efficacy of a Web-based PA behavior change program among cancer survivors. Methods: Nova Scotian cancer survivors (N=415) who previously expressed interest in a research study were approached. Interested participants were asked to complete an online assessment of PA and quality of life (QOL) before being randomized to either a theory-based PA behavior change program using the PA tracking website UWALK (UCAN; n=48) or usual care (UC; n=47). After the intervention (9 weeks), participants completed another online assessment of PA and QOL as well as measures to evaluate the program and website. Descriptive analyses from surveys and Web analytic software were used to assess feasibility and mean change scores were used to test efficacy. Results: Of all contacted survivors, 95 (22.3%, 95/415) completed baseline measures and were randomized with 84 (88%, 84/95) completing the 9-week assessment. The behavior change program and website were rated highly on the satisfaction items. Average logins were 10.3 (1.1 per week) and 26.0% (111/432) of the weekly modules were completed. Most participants (71%, 29/41) indicated they were more aware of their daily PA levels and 68% (28/41) found the site easily navigable. Adjusted group differences in total exercise minutes favored the UCAN group by an increase of 42 minutes (95% CI -65 to 150; P=.44, d=0.17). Results were more pronounced, though still nonsignificant, among those not meeting guidelines at baseline where UCAN increased PA by 52 minutes compared to a decrease of 15 minutes in UC (adjusted between group difference=75, 95% CI -95 to 244; P=.38, d=0.27). Conclusions: We found that Internet-delivery may be a feasible alternative to more costly methods to promote PA among Nova Scotian cancer survivors. Moreover, there was a trend toward increased PA among those in the UCAN group, especially among those who were not meeting PA guidelines at baseline. Future research should focus on recruiting inactive cancer survivors and engaging them in the website to determine the optimal potential of Web-based interventions for promoting PA in cancer survivors. %M 28410166 %R 10.2196/cancer.4586 %U http://cancer.jmir.org/2015/2/e12/ %U https://doi.org/10.2196/cancer.4586 %U http://www.ncbi.nlm.nih.gov/pubmed/28410166 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 11 %P e244 %T Smoking Cessation Intervention on Facebook: Which Content Generates the Best Engagement? %A Thrul,Johannes %A Klein,Alexandra B %A Ramo,Danielle E %+ Center for Tobacco Control Research and Education, University of California, San Francisco, 530 Parnassus Avenue, Suite 366, San Francisco, CA, 94143-1390, United States, 1 415 514 9340, Johannes.Thrul@ucsf.edu %K young adults %K smoking cessation %K Facebook %K engagement %K Transtheoretical Model %D 2015 %7 11.11.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Social media offer a great opportunity to deliver smoking cessation treatment to young adults, but previous online and social media interventions targeting health behavior change have struggled with low participant engagement. We examined engagement generated by content based on the Transtheoretical Model of Behavior Change (TTM) in a motivationally tailored smoking cessation intervention on Facebook. Objective: This study aimed to identify which intervention content based on the TTM (Decisional Balance and 10 processes of change) generated the highest engagement among participants in pre-action stages of change (Precontemplation, Contemplation, and Preparation). Methods: Participants (N=79, 20% female, mean age 20.8) were assessed for readiness to quit smoking and assigned to one of 7 secret Facebook groups tailored to their stage of change. Daily postings to the groups based on TTM Decisional Balance and the 10 processes of change were made by research staff over 3 months. Engagement was operationalized as the number of participant comments to each post. TTM content-based predictors of number of comments were analyzed and stratified by baseline stage of change, using negative binomial regression analyses with and without zero inflation. Results: A total of 512 TTM-based posts generated 630 individual comments. In Precontemplation and Contemplation groups, Decisional Balance posts generated above average engagement (P=.01 and P<.001). In Contemplation groups, posts based on the TTM processes Dramatic Relief and Self-Liberation resulted in below average engagement (P=.01 and P=.005). In Preparation groups, posts based on Consciousness Raising generated above average engagement (P=.009). Participant engagement decreased over time and differed between groups within Precontemplation and Contemplation stages, but was independent of day of the week and time of day the content was posted to the groups. No participant baseline characteristics significantly predicted engagement. Conclusions: Participants not ready to quit in the next 30 days (in Precontemplation or Contemplation) engaged most when prompted to think about the pros and cons of behavior change, while those in the Preparation stage engaged most when posts increased awareness about smoking and smoking cessation. Findings support tailoring intervention content to readiness to quit and suggest intervention components that may be most effective in generating high participant engagement on social media. %M 26561529 %R 10.2196/jmir.4575 %U http://www.jmir.org/2015/11/e244/ %U https://doi.org/10.2196/jmir.4575 %U http://www.ncbi.nlm.nih.gov/pubmed/26561529 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 11 %P e255 %T e-CBT (myCompass), Antidepressant Medication, and Face-to-Face Psychological Treatment for Depression in Australia: A Cost-Effectiveness Comparison %A Solomon,Daniela %A Proudfoot,Judith %A Clarke,Janine %A Christensen,Helen %+ Black Dog Institute, University of New South Wales, Hospital Rd Randwick, Sydney, , Australia, 61 0293829274, d.solomon@blackdog.org.au %K cost-utility analysis %K depression %K self-help %K computer-assisted therapy %D 2015 %7 11.11.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: The economic cost of depression is becoming an ever more important determinant for health policy and decision makers. Internet-based interventions with and without therapist support have been found to be effective options for the treatment of mild to moderate depression. With increasing demands on health resources and shortages of mental health care professionals, the integration of cost-effective treatment options such as Internet-based programs into primary health care could increase efficiency in terms of resource use and costs. Objective: Our aim was to evaluate the cost-effectiveness of an Internet-based intervention (myCompass) for the treatment of mild-to-moderate depression compared to treatment as usual and cognitive behavior therapy in a stepped care model. Methods: A decision model was constructed using a cost utility framework to show both costs and health outcomes. In accordance with current treatment guidelines, a stepped care model included myCompass as the first low-intervention step in care for a proportion of the model cohort, with participants beginning from a low-intensity intervention to increasing levels of treatment. Model parameters were based on data from the recent randomized controlled trial of myCompass, which showed that the intervention reduced symptoms of depression, anxiety, and stress and improved work and social functioning for people with symptoms in the mild-to-moderate range. Results: The average net monetary benefit (NMB) was calculated, identifying myCompass as the strategy with the highest net benefit. The mean incremental NMB per individual for the myCompass group was AUD 1165.88 compared to treatment as usual and AUD 522.58 for the cognitive behavioral therapy model. Conclusions: Internet-based interventions can provide cost-effective access to treatment when provided as part of a stepped care model. Widespread dissemination of Internet-based programs can potentially reduce demands on primary and tertiary services and reduce unmet need. %M 26561555 %R 10.2196/jmir.4207 %U http://www.jmir.org/2015/11/e255/ %U https://doi.org/10.2196/jmir.4207 %U http://www.ncbi.nlm.nih.gov/pubmed/26561555 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 10 %P e241 %T Web-Based STAR E-Learning Course Increases Empathy and Understanding in Dementia Caregivers: Results from a Randomized Controlled Trial in the Netherlands and the United Kingdom %A Hattink,Bart %A Meiland,Franka %A van der Roest,Henriëtte %A Kevern,Peter %A Abiuso,Francesca %A Bengtsson,Johan %A Giuliano,Angele %A Duca,Annalise %A Sanders,Jennifer %A Basnett,Fern %A Nugent,Chris %A Kingston,Paul %A Dröes,Rose-Marie %+ VU University medical center Amsterdam, Department of Psychiatry, GGZ inGeest Dienst Onderzoek en Innovatie - Overschiestraat, Postbus 74077, Amsterdam, 1070BB, Netherlands, 31 207885622, b.hattink@vumc.nl %K dementia %K caregivers %K distance-learning %K empathy %D 2015 %7 30.10.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: The doubling of the number of people with dementia in the coming decades coupled with the rapid decline in the working population in our graying society is expected to result in a large decrease in the number of professionals available to provide care to people with dementia. As a result, care will be supplied increasingly by untrained informal caregivers and volunteers. To promote effective care and avoid overburdening of untrained and trained caregivers, they must become properly skilled. To this end, the European Skills Training and Reskilling (STAR) project, which comprised experts from the domains of education, technology, and dementia care from 6 countries (the Netherlands, Sweden, Italy, Malta, Romania, and the United Kingdom), worked together to create and evaluate a multilingual e-learning tool. The STAR training portal provides dementia care training both for informal and formal caregivers. Objective: The objective of the current study was to evaluate the user friendliness, usefulness, and impact of STAR with informal caregivers, volunteers, and professional caregivers. Methods: For 2 to 4 months, the experimental group had access to the STAR training portal, a Web-based portal consisting of 8 modules, 2 of which had a basic level and 6 additional modules at intermediate and advanced levels. The experimental group also had access to online peer and expert communities for support and information exchange. The control group received free access to STAR after the research had ended. The STAR training portal was evaluated in a randomized controlled trial among informal caregivers and volunteers in addition to professional caregivers (N=142) in the Netherlands and the United Kingdom. Assessments were performed with self-assessed, online, standardized questionnaires at baseline and after 2 to 4 months. Primary outcome measures were user friendliness, usefulness, and impact of STAR on knowledge, attitudes, and approaches of caregivers regarding dementia. Secondary outcome measures were empathy, quality of life, burden, and caregivers’ sense of competence. Results: STAR was rated positively by all user groups on both usefulness and user friendliness. Significant effects were found on a person-centered care approach and on the total score on positive attitudes to dementia; both the experimental and the control group increased in score. Regarding empathy, significant improvements were found in the STAR training group on distress, empathic concern, and taking the perspective of the person with dementia. In the experimental group, however, there was a significant reduction in self-reported sense of competence. Conclusions: The STAR training portal is a useful and user-friendly e-learning method, which has demonstrated its ability to provide significant positive effects on caregiver attitudes and empathy. %M 26519106 %R 10.2196/jmir.4025 %U http://www.jmir.org/2015/10/e241/ %U https://doi.org/10.2196/jmir.4025 %U http://www.ncbi.nlm.nih.gov/pubmed/26519106 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 4 %P e129 %T Changes in Physical Activity and Psychological Variables Following a Web-Based Motivational Interviewing Intervention: Pilot Study %A Karnes,Sasha L %A Meyer,Barbara B %A Berger,Lisa M %A Brondino,Michael J %+ University of Wisconsin--Whitewater, Department of Psychology, Laurentide Hall, 800 W. Main St., Whitewater, WI, , United States, 1 262 472 3037, karness@uww.edu %K motivational interviewing %K physical activity %K adults %K Web-based %K intervention %K health care %K psychology %D 2015 %7 29.10.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Web-based interventions for enhancing physical activity participation are in demand for application in health care settings. Recent research suggests Web-based interventions that are based on motivational interviewing are effective to increase physical activity. It is unclear whether motivational interviewing can influence targeted psychological variables such as perceived readiness, willingness, and ability to participate in physical activity. Objective: The aims of this study were to determine whether there were changes in physical activity and psychological variables associated with readiness, willingness, and perceived ability to participate in physical activity following completion of a novel Web-based intervention. The goal of the motivational interviewing–based intervention was to increase physical activity. Methods: Twenty-three underactive or inactive urban dwelling adults were recruited at a medical office for participation in a 4-session Web-based intervention lasting approximately 15 minutes per week. Sessions were based on principles of motivational interviewing. Assessment of physical activity was conducted using pedometers immediately prior to intervention participation (pre) and immediately post intervention (post1). Self-report assessments of physical activity and psychological variables were conducted using online surveys at pre, post1, and again at one month following intervention participation (post2). Results: Comparisons of pre and post1 pedometer recordings revealed significant increases in steps per day (t22=2.09, P=.049). There were also significant changes in total physical activity energy expenditure per week (χ22=8.4, P=.02) and in moderate intensity physical activity energy expenditure per week (χ22=13.9, P<.001) over time following participation in the Web-based intervention. Significant changes in psychological variables following participation in the Web-based intervention included: (1) change in stage classification over time (χ22=21.5, P<.001), where the percentage of participants classified in the action or maintenance stages of change in physical activity increased over time (pre=25% [6/24], post1=71% [17/24], post2=68% [15/22]); (2) decreases in self-reported decisional balance cons (F2,42=12.76, P<.001); (3) increases in self-reported decisional balance pros (F2,42=16.19, P<.001); (4) increases in physical activity enjoyment (F2,20=3.85, P=.04); and (5) increases in self-efficacy (F2,42=3.30, P=.047). Conclusions: The Web-based intervention piloted in this study shows preliminary promise as a tool to promote physical activity in health care settings. Additional research is needed to test the effectiveness of motivational interviewing compared to a control condition and to refine content by considering mediation by psychological variables in a larger sample. %M 26515668 %R 10.2196/resprot.4623 %U http://www.researchprotocols.org/2015/4/e129/ %U https://doi.org/10.2196/resprot.4623 %U http://www.ncbi.nlm.nih.gov/pubmed/26515668 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 4 %P e123 %T Twitter-Delivered Behavioral Weight-Loss Interventions: A Pilot Series %A Pagoto,Sherry L %A Waring,Molly E %A Schneider,Kristin L %A Oleski,Jessica L %A Olendzki,Effie %A Hayes,Rashelle B %A Appelhans,Bradley M %A Whited,Matthew C %A Busch,Andrew M %A Lemon,Stephenie C %+ Division of Preventive and Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA, 01655, United States, 1 508 856 2092, Sherry.Pagoto@umassmed.edu %K social networks %K Twitter %K obesity %K weight loss %K online social networking %K peer-to-peer health care %K digital health %D 2015 %7 23.10.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Lifestyle interventions are efficacious at reducing risk for diabetes and cardiovascular disease but have not had a significant public health impact given high cost and patient and provider burden. Objective: Online social networks may reduce the burden of lifestyle interventions to the extent that they displace in-person visits and may enhance opportunities for social support for weight loss. Methods: We conducted an iterative series of pilot studies to evaluate the feasibility and acceptability of using online social networks to deliver a lifestyle intervention. Results: In Study 1 (n=10), obese participants with depression received lifestyle counseling via 12 weekly group visits and a private group formed using the online social network, Twitter. Mean weight loss was 2.3 pounds (SD 7.7; range -19.2 to 8.2) or 1.2% (SD 3.6) of baseline weight. A total of 67% (6/9) of participants completing exit interviews found the support of the Twitter group at least somewhat useful. In Study 2 (n=11), participants were not depressed and were required to be regular users of social media. Participants lost, on average, 5.6 pounds (SD 6.3; range -15 to 0) or 3.0% (SD 3.4) of baseline weight, and 100% (9/9) completing exit interviews found the support of the Twitter group at least somewhat useful. To explore the feasibility of eliminating in-person visits, in Study 3 (n=12), we delivered a 12-week lifestyle intervention almost entirely via Twitter by limiting the number of group visits to one, while using the same inclusion criteria as that used in Study 2. Participants lost, on average, 5.4 pounds (SD 6.4; range -14.2 to 3.9) or 3.0% (SD 3.1) of baseline weight, and 90% (9/10) completing exit interviews found the support of the Twitter group at least somewhat useful. Findings revealed that a private Twitter weight-loss group was both feasible and acceptable for many patients, particularly among regular users of social media. Conclusions: Future research should evaluate the efficacy and cost-effectiveness of online social network-delivered lifestyle interventions relative to traditional modalities. %M 26500186 %R 10.2196/resprot.4864 %U http://www.researchprotocols.org/2015/4/e123/ %U https://doi.org/10.2196/resprot.4864 %U http://www.ncbi.nlm.nih.gov/pubmed/26500186 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 10 %P e240 %T Diabetes Prevention and Weight Loss with a Fully Automated Behavioral Intervention by Email, Web, and Mobile Phone: A Randomized Controlled Trial Among Persons with Prediabetes %A Block,Gladys %A Azar,Kristen MJ %A Romanelli,Robert J %A Block,Torin J %A Hopkins,Donald %A Carpenter,Heather A %A Dolginsky,Marina S %A Hudes,Mark L %A Palaniappan,Latha P %A Block,Clifford H %+ Turnaround Health, a division of NutritionQuest, 15 Shattuck Square, Suite 288, Berkeley, CA, 94704, United States, 1 510 704 8514, gblock@berkeley.edu %K type 2 diabetes %K prevention %K intervention studies %K prediabetes %K behavior change %K obesity %K physical activity %K nutrition %K Internet %K smartphone %K weight loss %D 2015 %7 23.10.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: One-third of US adults, 86 million people, have prediabetes. Two-thirds of adults are overweight or obese and at risk for diabetes. Effective and affordable interventions are needed that can reach these 86 million, and others at high risk, to reduce their progression to diagnosed diabetes. Objective: The aim was to evaluate the effectiveness of a fully automated algorithm-driven behavioral intervention for diabetes prevention, Alive-PD, delivered via the Web, Internet, mobile phone, and automated phone calls. Methods: Alive-PD provided tailored behavioral support for improvements in physical activity, eating habits, and factors such as weight loss, stress, and sleep. Weekly emails suggested small-step goals and linked to an individual Web page with tools for tracking, coaching, social support through virtual teams, competition, and health information. A mobile phone app and automated phone calls provided further support. The trial randomly assigned 339 persons to the Alive-PD intervention (n=163) or a 6-month wait-list usual-care control group (n=176). Participants were eligible if either fasting glucose or glycated hemoglobin A1c (HbA1c) was in the prediabetic range. Primary outcome measures were changes in fasting glucose and HbA1c at 6 months. Secondary outcome measures included clinic-measured changes in body weight, body mass index (BMI), waist circumference, triglyceride/high-density lipoprotein cholesterol (TG/HDL) ratio, and Framingham diabetes risk score. Analysis was by intention-to-treat. Results: Participants’ mean age was 55 (SD 8.9) years, mean BMI was 31.2 (SD 4.4) kg/m2, and 68.7% (233/339) were male. Mean fasting glucose was in the prediabetic range (mean 109.9, SD 8.4 mg/dL), whereas the mean HbA1c was 5.6% (SD 0.3), in the normal range. In intention-to-treat analyses, Alive-PD participants achieved significantly greater reductions than controls in fasting glucose (mean –7.36 mg/dL, 95% CI –7.85 to –6.87 vs mean –2.19, 95% CI –2.64 to –1.73, P<.001), HbA1c (mean –0.26%, 95% CI –0.27 to –0.24 vs mean –0.18%, 95% CI –0.19 to –0.16, P<.001), and body weight (mean –3.26 kg, 95% CI –3.26 to –3.25 vs mean –1.26 kg, 95% CI –1.27 to –1.26, P<.001). Reductions in BMI, waist circumference, and TG/HDL were also significantly greater in Alive-PD participants than in the control group. At 6 months, the Alive-PD group reduced their Framingham 8-year diabetes risk from 16% to 11%, significantly more than the control group (P<.001). Participation and retention was good; intervention participants interacted with the program a median of 17 (IQR 14) of 24 weeks and 71.1% (116/163) were still interacting with the program in month 6. Conclusions: Alive-PD improved glycemic control, body weight, BMI, waist circumference, TG/HDL ratio, and diabetes risk. As a fully automated system, the program has high potential for scalability and could potentially reach many of the 86 million US adults who have prediabetes as well as other at-risk groups. Trial Registration: Clinicaltrials.gov NCT01479062; https://clinicaltrials.gov/ct2/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6bt4V20NR) %M 26499966 %R 10.2196/jmir.4897 %U http://www.jmir.org/2015/10/e240/ %U https://doi.org/10.2196/jmir.4897 %U http://www.ncbi.nlm.nih.gov/pubmed/26499966 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 4 %P e125 %T Effectiveness of a Mobile Phone App for Adults That Uses Physical Activity as a Tool to Manage Cigarette Craving After Smoking Cessation: A Study Protocol for a Randomized Controlled Trial %A Hassandra,Mary %A Lintunen,Taru %A Kettunen,Tarja %A Vanhala,Mauno %A Toivonen,Hanna-Mari %A Kinnunen,Kimmo %A Heikkinen,Risto %+ Department of Sport Sciences, University of Jyväskylä, PO Box 35, Jyväskylä, 40014, Finland, 358 408053979, maria.m.chasandra@jyu.fi %K behavior change %K mHealth app %K physical activity %K randomized controlled trial %K relapse prevention %K smoking %D 2015 %7 22.10.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Results from studies on the effects of exercise on smoking-related variables have provided strong evidence that physical activity acutely reduces cigarette cravings. Mobile technology may provide some valuable tools to move from explanatory randomized controlled trials to pragmatic randomized controlled trials by testing the acute effectiveness of exercise on quitters under real-life conditions. An mHealth app was developed to be used as a support tool for quitters to manage their cigarette cravings. Objective: The primary aim of this paper is to present the protocol of a study examining the effectiveness of the Physical over smoking app (Ph.o.S) by comparing the point prevalence abstinence rate of a group of users to a comparator group during a 6-month follow-up period. Methods: After initial Web-based screening, eligible participants are recruited to attend a smoking cessation program for 3 weeks to set a quit smoking date. Fifty participants who succeed in quitting will be randomly allocated to the comparator and experimental groups. Both groups will separately have 1 more counseling session on how to manage cravings. In this fourth session, the only difference in treatment between the groups is that the experimental group will have an extra 10-15 minutes of guidance on how to use the fully automated Ph.o.S app to manage cravings during the follow-up period. Data will be collected at baseline, as well as before and after the quit day, and follow-up Web-based measures will be collected for a period of 6 months. The primary efficacy outcome is the 7-day point prevalence abstinence rate, and secondary efficacy outcomes are number of relapses and cravings, self-efficacy of being aware of craving experience, self-efficacy in managing cravings, and power of control in managing cravings. Results: Recruitment for this project commenced in December 2014, and proceeded until May 2015. Follow-up data collection has commenced and will be completed by the end of December 2015. Conclusions: If the Ph.o.S app is shown to be effective, the study will provide evidence for the use of the app as a support tool for people who are trying to manage cravings during smoking cessation programs. It is anticipated that the results of the study will provide knowledge of how physical activity affects cigarette craving in real-life situations and inform the development and delivery of relapse prevention in smoking cessation treatment. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN55259451; http://www.controlled-trials.com/ISRCTN55259451 (Archived by WebCite at http://www.webcitation.org/6cKF2mzEI) %M 26494256 %R 10.2196/resprot.4600 %U http://www.researchprotocols.org/2015/4/e125/ %U https://doi.org/10.2196/resprot.4600 %U http://www.ncbi.nlm.nih.gov/pubmed/26494256 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 10 %P e238 %T Using WhatsApp and Facebook Online Social Groups for Smoking Relapse Prevention for Recent Quitters: A Pilot Pragmatic Cluster Randomized Controlled Trial %A Cheung,Yee Tak Derek %A Chan,Ching Han Helen %A Lai,Chi-Keung Jonah %A Chan,Wai Fung Vivian %A Wang,Man Ping %A Li,Ho Cheung William %A Chan,Sophia Siu Chee %A Lam,Tai-Hing %+ School of Public Health, The University of Hong Kong, 5/F William MW Mong Block, 21 Sassoon Road, Hong Kong, Hong Kong, China (Hong Kong), 852 39176652, derekcheung@hku.hk %K social networking %K social media %K smoking cessation %K relapse prevention %D 2015 %7 22.10.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Quit attempters often have episodes of smoking relapse before they eventually quit. Interactive text messaging through mobile phones has been shown to increase abstinence. This service can be potentially applied on the platform of a social networking service to help quitters maintain abstinence. Objective: Our aim was to determine if the group discussion and reminders via the WhatsApp or Facebook social group were effective to prevent smoking relapse in quitters who had stopped smoking recently. Methods: This was a single-blinded, parallel, 3-arm pilot cluster randomized controlled trial allocating recent quitters, who had completed an 8-week treatment and reported abstinence for at least 7 days, to WhatsApp (n=42), Facebook (n=40), and a control group (n=54). The 2 intervention groups participated in a 2-month online group discussion with either WhatsApp or Facebook moderated by a trained smoking cessation counselor and received a self-help booklet on smoking cessation. The control group only received the booklet. The primary outcome was the 2- and 6-month relapse rates, defined as the proportion of participants who smoked at least 5 cigarettes in 3 consecutive days. Results: Fewer participants in the WhatsApp group (17%, 7/42) reported relapse than the control group (42.6%, 23/54) at 2-month (OR 0.27, 95% CI 0.10-0.71) and 6-month (40.5%, 17/42 vs 61.1%, 33/54; OR 0.43, 95% CI 0.19-0.99) follow-ups. The Facebook group (30.0%, 12/40) had an insignificantly lower relapse rate than the control group (42.6%, 23/54) at 2-month (OR 0.58, 95% CI 0.24-1.37) and 6-month (52.5%, 13/40 vs 61.1%, 33/54; OR 0.70, 95% CI 0.31-1.61) follow-ups. The WhatsApp social groups had more moderators’ posts (median 60, IQR 25 vs median 32, IQR 7; P=.05) and participants’ posts (median 35, IQR 50 vs median 6, IQR 9; P=.07) than their Facebook counterparts, but the difference was insignificant. Conclusions: The intervention via the WhatsApp social group was effective in reducing relapse probably because of enhanced discussion and social support. Inactive discussion in the Facebook social group might have attributed to the lower effectiveness. ClinicalTrial: Clinicaltrials.gov NCT02007369; https://clinicaltrials.gov/show/NCT02007369 (Archived by WebCite® at http://www.webcitation.org/6c3RbltQG) %M 26494159 %R 10.2196/jmir.4829 %U http://www.jmir.org/2015/10/e238/ %U https://doi.org/10.2196/jmir.4829 %U http://www.ncbi.nlm.nih.gov/pubmed/26494159 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 10 %P e237 %T Text Message and Internet Support for Coronary Heart Disease Self-Management: Results From the Text4Heart Randomized Controlled Trial %A Pfaeffli Dale,Leila %A Whittaker,Robyn %A Jiang,Yannan %A Stewart,Ralph %A Rolleston,Anna %A Maddison,Ralph %+ National Institute for Health Innovation, University of Auckland, School of Population Health, Tamaki Campus, 261 Morrin Rd, Auckland, 1072, New Zealand, 64 9 373 7599, l.pfaeffli@auckland.ac.nz %K text messaging %K mHealth %K cellular phone %K cardiovascular diseases %K intervention %K lifestyle change %K behavior %D 2015 %7 21.10.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Mobile technology has the potential to deliver behavior change interventions (mHealth) to reduce coronary heart disease (CHD) at modest cost. Previous studies have focused on single behaviors; however, cardiac rehabilitation (CR), a component of CHD self-management, needs to address multiple risk factors. Objective: The aim was to investigate the effectiveness of a mHealth-delivered comprehensive CR program (Text4Heart) to improve adherence to recommended lifestyle behaviors (smoking cessation, physical activity, healthy diet, and nonharmful alcohol use) in addition to usual care (traditional CR). Methods: A 2-arm, parallel, randomized controlled trial was conducted in New Zealand adults diagnosed with CHD. Participants were recruited in-hospital and were encouraged to attend center-based CR (usual care control). In addition, the intervention group received a personalized 24-week mHealth program, framed in social cognitive theory, sent by fully automated daily short message service (SMS) text messages and a supporting website. The primary outcome was adherence to healthy lifestyle behaviors measured using a self-reported composite health behavior score (≥3) at 3 and 6 months. Secondary outcomes included clinical outcomes, medication adherence score, self-efficacy, illness perceptions, and anxiety and/or depression at 6 months. Baseline and 6-month follow-up assessments (unblinded) were conducted in person. Results: Eligible patients (N=123) recruited from 2 large metropolitan hospitals were randomized to the intervention (n=61) or the control (n=62) group. Participants were predominantly male (100/123, 81.3%), New Zealand European (73/123, 59.3%), with a mean age of 59.5 (SD 11.1) years. A significant treatment effect in favor of the intervention was observed for the primary outcome at 3 months (AOR 2.55, 95% CI 1.12-5.84; P=.03), but not at 6 months (AOR 1.93, 95% CI 0.83-4.53; P=.13). The intervention group reported significantly greater medication adherence score (mean difference: 0.58, 95% CI 0.19-0.97; P=.004). The majority of intervention participants reported reading all their text messages (52/61, 85%). The number of visits to the website per person ranged from zero to 100 (median 3) over the 6-month intervention period. Conclusions: A mHealth CR intervention plus usual care showed a positive effect on adherence to multiple lifestyle behavior changes at 3 months in New Zealand adults with CHD compared to usual care alone. The effect was not sustained to the end of the 6-month intervention. A larger study is needed to determine the size of the effect in the longer term and whether the change in behavior reduces adverse cardiovascular events. Trial Registration: ACTRN 12613000901707; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364758&isReview=true (Archived by WebCite at http://www.webcitation.org/6c4qhcHKt) %M 26490012 %R 10.2196/jmir.4944 %U http://www.jmir.org/2015/10/e237/ %U https://doi.org/10.2196/jmir.4944 %U http://www.ncbi.nlm.nih.gov/pubmed/26490012 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 10 %P e235 %T An eHealth Application in Head and Neck Cancer Survivorship Care: Health Care Professionals' Perspectives %A Duman-Lubberding,Sanne %A van Uden-Kraan,Cornelia F %A Peek,Niels %A Cuijpers,Pim %A Leemans,C René %A Verdonck-de Leeuw,Irma M %+ Department of Otolaryngology / Head and Neck Surgery, VU University Medical Center, PO Box 7057, Amsterdam, 1007 MB, Netherlands, 31 20 444 0931, s.lubberding@vumc.nl %K cancer %K tertiary prevention %K participatory design approach %K follow-up care %K supportive care %D 2015 %7 21.10.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Although many cancer survivors could benefit from supportive care, they often do not utilize such services. Previous studies have shown that patient-reported outcomes (PROs) could be a solution to meet cancer survivors’ needs, for example through an eHealth application that monitors quality of life and provides personalized advice and supportive care options. In order to develop an effective application that can successfully be implemented in current health care, it is important to include health care professionals in the development process. Objective: The aim of this study was to investigate health care professionals’ perspectives toward follow-up care and an eHealth application, OncoKompas, in follow-up cancer care that monitors quality of life via PROs, followed by automatically generated tailored feedback and personalized advice on supportive care. Methods: Health care professionals involved in head and neck cancer care (N=11) were interviewed on current follow-up care and the anticipated value of the proposed eHealth application (Step 1). A prototype of the eHealth application, OncoKompas, was developed (Step 2). Cognitive walkthroughs were conducted among health care professionals (N=21) to investigate perceived usability (Step 3). Interviews were recorded, transcribed verbatim, and analyzed by 2 coders. Results: Health care professionals indicated several barriers in current follow-up care including difficulties in detecting symptoms, patients’ perceived need for supportive care, and a lack of time to encourage survivors to obtain supportive care. Health care professionals expected the eHealth application to be of added value. The cognitive walkthroughs demonstrated that health care professionals emphasized the importance of tailoring care. They considered the navigation structure of OncoKompas to be complex. Health care professionals differed in their opinion toward the best strategy to implement the application in clinical practice but indicated that it should be incorporated in the HNC cancer care pathway to ensure all survivors would benefit. Conclusions: Health care professionals experienced several barriers in directing patients to supportive care. They were positive toward the development and implementation of an eHealth application and expected it could support survivors in obtaining supportive care tailored to their needs. The cognitive walkthroughs revealed several points for optimizing the application prototype and developing an efficient implementation strategy. Including health care professionals in an early phase of a participatory design approach is valuable in developing an eHealth application and an implementation strategy meeting stakeholders’ needs. %M 26489918 %R 10.2196/jmir.4870 %U http://www.jmir.org/2015/10/e235/ %U https://doi.org/10.2196/jmir.4870 %U http://www.ncbi.nlm.nih.gov/pubmed/26489918 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 4 %P e124 %T Virtual Nursing Intervention Adjunctive to Conventional Care: The Experience of Persons Living With HIV %A Côté,José %A Rouleau,Geneviève %A Ramirez-Garcia,Pilar %A Bourbonnais,Anne %+ Research Centre of the Centre Hospitalier de l’Université de Montréal, Research Chair in Innovative Nursing Practices, 850 rue St-Denis, Tour St-Antoine, 3rd floor, local S03-424, Montréal, QC, H2X 0A9, Canada, 1 514 890 8000 ext 15536, jose.cote@umontreal.ca %K medication adherence %K anti-HIV agents %K Internet %K HIV infections %K nursing research %K qualitative research %K web-based interventions %D 2015 %7 20.10.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Persons living with HIV (PLHIV) must adhere optimally to antiretroviral therapy (ART) on a daily basis and for their lifetime to maintain an undetectable viral load, allowing them to preserve their health. Taking advantage of the opportunity that information and communication technologies provide to broaden intervention modalities and intensify clinical follow-up, a virtual nursing intervention consisting of four interactive computer sessions was developed to empower PLHIV to manage their ART and symptoms optimally. Compared with other types of information and communication technologies-assisted interventions such as text messages, HIV Treatment, Virtual Nursing Assistance and Education (VIH-TAVIE) requires a certain degree of active engagement on the part of the user to develop and strengthen the self-management skills to optimize adherence. After the intervention’s impact on ART adherence was measured quantitatively, a qualitative study was undertaken to describe how users experience the intervention. Understanding how PLHIV perceive being assisted asynchronously by a virtual nurse was of particular interest. Objective: The objective of the study was to explore and describe how PLHIV experience VIH-TAVIE, that is, receiving customized asynchronous accompaniment via a virtual nurse. Methods: A qualitative study was conducted with 26 PLHIV (20 men, 6 women) who received all four VIH-TAVIE sessions. Participants had been diagnosed with HIV 14 years earlier on average and had been on ART for a mean period of 10 years. The sessions lasted 20-30 minutes each and were received two weeks apart. They are hosted by a virtual nurse who engages the user in a self-management skills-learning process for the purpose of treatment adherence. Semistructured interviews were conducted lasting 30-40 minutes to get participants to share their experience of the intervention through personal stories and what they thought and felt during their participation. Data were analyzed using Miles and Huberman’s method, by performing these three steps: (1) data reduction (data coding, summaries); (2) data display (in tables and text form); and (3) recontextualization of results. Results: Content analysis yielded five themes regarding how PLHIV experience VIH-TAVIE: (1) exposure to the virtual nursing intervention; (2) virtual nurse humanizes experience of the computer-delivered intervention; (3) learner’s experience of the virtual nursing intervention; (4) perceived benefits following participation in the virtual nursing intervention; and (5) relevance of the virtual nursing intervention in relation to the medication management trajectory. Conclusions: Analyzing the participants’ experience revealed they found the intervention’s content and format appropriate. To them, the virtual nurse humanized the experience and helped them acquire new skills for achieving optimal ART adherence. Results seem to underscore the importance of offering the intervention to persons who have more problems with drug intake or who are just beginning ART. %M 26487327 %R 10.2196/resprot.4158 %U http://www.researchprotocols.org/2015/4/e124/ %U https://doi.org/10.2196/resprot.4158 %U http://www.ncbi.nlm.nih.gov/pubmed/26487327 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 10 %P e236 %T Comparing a Video and Text Version of a Web-Based Computer-Tailored Intervention for Obesity Prevention: A Randomized Controlled Trial %A Walthouwer,Michel Jean Louis %A Oenema,Anke %A Lechner,Lilian %A de Vries,Hein %+ Maastricht University, Department of Health Promotion, PO Box 616, Maastricht, 6200 MD, Netherlands, 31 43 3882402, michel.walthouwer@maastrichtuniversity.nl %K randomized controlled trial %K web-based %K computer-tailoring %K obesity %K educational level %K delivery strategy %D 2015 %7 19.10.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based computer-tailored interventions often suffer from small effect sizes and high drop-out rates, particularly among people with a low level of education. Using videos as a delivery format can possibly improve the effects and attractiveness of these interventions Objective: The main aim of this study was to examine the effects of a video and text version of a Web-based computer-tailored obesity prevention intervention on dietary intake, physical activity, and body mass index (BMI) among Dutch adults. A second study aim was to examine differences in appreciation between the video and text version. The final study aim was to examine possible differences in intervention effects and appreciation per educational level. Methods: A three-armed randomized controlled trial was conducted with a baseline and 6 months follow-up measurement. The intervention consisted of six sessions, lasting about 15 minutes each. In the video version, the core tailored information was provided by means of videos. In the text version, the same tailored information was provided in text format. Outcome variables were self-reported and included BMI, physical activity, energy intake, and appreciation of the intervention. Multiple imputation was used to replace missing values. The effect analyses were carried out with multiple linear regression analyses and adjusted for confounders. The process evaluation data were analyzed with independent samples t tests. Results: The baseline questionnaire was completed by 1419 participants and the 6 months follow-up measurement by 1015 participants (71.53%). No significant interaction effects of educational level were found on any of the outcome variables. Compared to the control condition, the video version resulted in lower BMI (B=-0.25, P=.049) and lower average daily energy intake from energy-dense food products (B=-175.58, P<.001), while the text version had an effect only on energy intake (B=-163.05, P=.001). No effects on physical activity were found. Moreover, the video version was rated significantly better than the text version on feelings of relatedness (P=.041), usefulness (P=.047), and grade given to the intervention (P=.018). Conclusions: The video version of the Web-based computer-tailored obesity prevention intervention was the most effective intervention and most appreciated. Future research needs to examine if the effects are maintained in the long term and how the intervention can be optimized. ClinicalTrial: Netherlands Trial Register: NTR3501; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3501 (Archived by WebCite at http://www.webcitation.org/6cBKIMaW1) %M 26481772 %R 10.2196/jmir.4083 %U http://www.jmir.org/2015/10/e236/ %U https://doi.org/10.2196/jmir.4083 %U http://www.ncbi.nlm.nih.gov/pubmed/26481772 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 4 %P e122 %T TRAK App Suite: A Web-Based Intervention for Delivering Standard Care for the Rehabilitation of Knee Conditions %A Spasić,Irena %A Button,Kate %A Divoli,Anna %A Gupta,Satyam %A Pataky,Tamas %A Pizzocaro,Diego %A Preece,Alun %A van Deursen,Robert %A Wilson,Chris %+ School of Computer Science & Informatics, Cardiff University, Queen's Buildings, 5 The Parade, Cardiff, CF24 3AA, United Kingdom, 44 029 2087 0320, i.spasic@cs.cardiff.ac.uk %K internet %K social media %K web applications %K mobile applications %K usability testing %K knee %K rehabilitation %K exercise %K self-management %D 2015 %7 16.10.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Standard care for the rehabilitation of knee conditions involves exercise programs and information provision. Current methods of rehabilitation delivery struggle to keep up with large volumes of patients and the length of treatment required to maximize the recovery. Therefore, the development of novel interventions to support self-management is strongly recommended. Such interventions need to include information provision, goal setting, monitoring, feedback, and support groups, but the most effective methods of their delivery are poorly understood. The Internet provides a medium for intervention delivery with considerable potential for meeting these needs. Objective: The objective of this study was to demonstrate the feasibility of a Web-based app and to conduct a preliminary review of its practicability as part of a complex medical intervention in the rehabilitation of knee disorders. This paper describes the development, implementation, and usability of such an app. Methods: An interdisciplinary team of health care professionals and researchers, computer scientists, and app developers developed the TRAK app suite. The key functionality of the app includes information provision, a three-step exercise program based on a standard care for the rehabilitation of knee conditions, self-monitoring with visual feedback, and a virtual support group. There were two types of stakeholders (patients and physiotherapists) that were recruited for the usability study. The usability questionnaire was used to collect both qualitative and quantitative information on computer and Internet usage, task completion, and subjective user preferences. Results: A total of 16 patients and 15 physiotherapists participated in the usability study. Based on the System Usability Scale, the TRAK app has higher perceived usability than 70% of systems. Both patients and physiotherapists agreed that the given Web-based approach would facilitate communication, provide information, help recall information, improve understanding, enable exercise progression, and support self-management in general. The Web app was found to be easy to use and user satisfaction was very high. The TRAK app suite can be accessed at http://apps.facebook.com/kneetrak/. Conclusions: The usability study suggests that a Web-based intervention is feasible and acceptable in supporting self-management of knee conditions. %M 26474643 %R 10.2196/resprot.4091 %U http://www.researchprotocols.org/2015/4/e122/ %U https://doi.org/10.2196/resprot.4091 %U http://www.ncbi.nlm.nih.gov/pubmed/26474643 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 10 %P e231 %T Effects of a Web-Based Personalized Intervention on Physical Activity in European Adults: A Randomized Controlled Trial %A Marsaux,Cyril FM %A Celis-Morales,Carlos %A Fallaize,Rosalind %A Macready,Anna L %A Kolossa,Silvia %A Woolhead,Clara %A O'Donovan,Clare B %A Forster,Hannah %A Navas-Carretero,Santiago %A San-Cristobal,Rodrigo %A Lambrinou,Christina-Paulina %A Moschonis,George %A Surwillo,Agnieszka %A Godlewska,Magdalena %A Goris,Annelies %A Hoonhout,Jettie %A Drevon,Christian A %A Manios,Yannis %A Traczyk,Iwona %A Walsh,Marianne C %A Gibney,Eileen R %A Brennan,Lorraine %A Martinez,J Alfredo %A Lovegrove,Julie A %A Gibney,Michael J %A Daniel,Hannelore %A Mathers,John C %A Saris,Wim HM %+ Department of Human Biology, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre + (MUMC+), PO Box 616, Maastricht, 6200 MD, Netherlands, 31 433881379, c.marsaux@maastrichtuniversity.nl %K physical activity %K eHealth %K randomized controlled trial %K personalized nutrition %K genotype %K phenotype %K Internet %D 2015 %7 14.10.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: The high prevalence of physical inactivity worldwide calls for innovative and more effective ways to promote physical activity (PA). There are limited objective data on the effectiveness of Web-based personalized feedback on increasing PA in adults. Objective: It is hypothesized that providing personalized advice based on PA measured objectively alongside diet, phenotype, or genotype information would lead to larger and more sustained changes in PA, compared with nonpersonalized advice. Methods: A total of 1607 adults in seven European countries were randomized to either a control group (nonpersonalized advice, Level 0, L0) or to one of three personalized groups receiving personalized advice via the Internet based on current PA plus diet (Level 1, L1), PA plus diet and phenotype (Level 2, L2), or PA plus diet, phenotype, and genotype (Level 3, L3). PA was measured for 6 months using triaxial accelerometers, and self-reported using the Baecke questionnaire. Outcomes were objective and self-reported PA after 3 and 6 months. Results: While 1270 participants (85.81% of 1480 actual starters) completed the 6-month trial, 1233 (83.31%) self-reported PA at both baseline and month 6, but only 730 (49.32%) had sufficient objective PA data at both time points. For the total cohort after 6 months, a greater improvement in self-reported total PA (P=.02) and PA during leisure (nonsport) (P=.03) was observed in personalized groups compared with the control group. For individuals advised to increase PA, we also observed greater improvements in those two self-reported indices (P=.006 and P=.008, respectively) with increased personalization of the advice (L2 and L3 vs L1). However, there were no significant differences in accelerometer results between personalized and control groups, and no significant effect of adding phenotypic or genotypic information to the tailored feedback at month 3 or 6. After 6 months, there were small but significant improvements in the objectively measured physical activity level (P<.05), moderate PA (P<.01), and sedentary time (P<.001) for individuals advised to increase PA, but these changes were similar across all groups. Conclusions: Different levels of personalization produced similar small changes in objective PA. We found no evidence that personalized advice is more effective than conventional “one size fits all” guidelines to promote changes in PA in our Web-based intervention when PA was measured objectively. Based on self-reports, PA increased to a greater extent with more personalized advice. Thus, it is crucial to measure PA objectively in any PA intervention study. Trial Registration: ClinicalTrials.gov NCT01530139; http://clinicaltrials.gov/show/NCT01530139 (Archived by WebCite at: http://www.webcitation.org/6XII1QwHz) %M 26467573 %R 10.2196/jmir.4660 %U http://www.jmir.org/2015/10/e231/ %U https://doi.org/10.2196/jmir.4660 %U http://www.ncbi.nlm.nih.gov/pubmed/26467573 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 10 %P e232 %T A Web-Based Self-Help Intervention With and Without Chat Counseling to Reduce Cannabis Use in Problematic Cannabis Users: Three-Arm Randomized Controlled Trial %A Schaub,Michael P %A Wenger,Andreas %A Berg,Oliver %A Beck,Thilo %A Stark,Lars %A Buehler,Eveline %A Haug,Severin %+ Swiss Research Institute for Public Health and Addiction (ISGF), associated to the University of Zurich and World Health Organization Collaborating Center, Konradstrasse 32, Zurich, 8031, Switzerland, 41 444481165, michael.schaub@isgf.uzh.ch %K cannabis %K Internet %K chat %K Web based %K self-help %K cognitive behavioral therapy %K motivational interviewing %K counseling %K self-control %K behavioral self-management %D 2015 %7 13.10.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: After alcohol and tobacco, cannabis is the most widely used psychoactive substance in many countries worldwide. Although approximately one in ten users develops serious problems of dependency, only a minority attend outpatient addiction counseling centers. A Web-based intervention could potentially reach those users who hesitate to approach such treatment centers. Objective: To test the efficacy of a Web-based self-help intervention with and without chat counseling—Can Reduce—in reducing the cannabis use of problematic cannabis users as an alternative to outpatient treatment services. Methods: Altogether, 436 participants were recruited by various online and offline media for the Web-based trial. A total of 308 of these were eligible for study participation and were randomly allocated in an unblinded manner to either self-help with chat (n=114), self-help without chat (n=101), or a waiting list control group (n=93). The fully automated self-help intervention consisted of eight modules designed to reduce cannabis use, and was based on the principles of motivational interviewing, self-control practices, and methods of cognitive behavioral therapy. Additional individual chat counseling sessions were based on the same therapeutic principles. The sessions were conducted by trained counselors and addressed participants' personal problems. The main outcomes were the frequency (number of days) and quantity of cannabis use (number of standardized joints) per week, as entered into the consumption diary at baseline and at the 3-month follow-up. Secondary outcomes included self-reported symptoms of cannabis use disorder, severity of cannabis dependence, risky alcohol use, and mental health symptoms. Intervention participation and retention were extracted from the user progress data and the consumption diary, respectively. Results: Can Reduce participants were older (U=2.296, P=.02) and reported a greater number of cannabis use days at baseline than patients who entered outpatient treatment with cannabis as their main problem substance (data from the Swiss treatment demand monitoring statistics were used; chi-square [df 2]=4.0, P=.046). Participants in the self-help with chat study arm completed a mean of 3.2 modules and 27 out of 114 (23.7%) of the participants received at least one chat session. Participants in the self-help without chat study arm completed similar numbers of self-help modules. A total of 117 of 308 participants (38.0%) completed the 3-month follow-up assessment. The change in the mean number of cannabis use days per week at 3 months differed between self-help without chat (mean change 0.7, SD -0.2) and self-help with chat (mean change 1.4, SD -0.5; beta=-0.75, SE=0.32, t=-2.39, P=.02, d=0.34, 95% CI 0.07-0.61), as well as between self-help with chat and waiting list (mean change 1.0, SD -0.8; beta=0.70, SE=0.32, t=2.16, P=.03, d=0.20, 95% CI -0.07 to 0.47). However, there were no differences between self-help without chat and waiting list (beta=-0.05, SE=0.33, t=-0.16, P=.87, d=-0.14, 95% CI -0.43 to 0.14). Self-reported abstinence was significantly different in the self-help without chat study arm (2.0%) than in the self-help with chat study arm (8.8%; beta=-1.56, SE=0.79, P=.05, odds ratio [OR]=0.21, 95% CI 0.02-2.33). There were no significant differences between the study arms with respect to the secondary outcomes. Conclusions: Web-based self-help interventions supplemented by brief chat counseling are an effective alternative to face-to-face treatment and can reach a group of cannabis users who differ in their use and sociodemographic characteristics from those who enter outpatient addiction treatment. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 59948178; http://www.isrctn.com/ISRCTN59948178 (Archived by WebCite at http://www.webcitation.org/6bt01gfIr) %M 26462848 %R 10.2196/jmir.4860 %U http://www.jmir.org/2015/10/e232/ %U https://doi.org/10.2196/jmir.4860 %U http://www.ncbi.nlm.nih.gov/pubmed/26462848 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 10 %P e230 %T Views of People With High and Low Levels of Health Literacy About a Digital Intervention to Promote Physical Activity for Diabetes: A Qualitative Study in Five Countries %A Rowsell,Alison %A Muller,Ingrid %A Murray,Elizabeth %A Little,Paul %A Byrne,Christopher D %A Ganahl,Kristin %A Müller,Gabriele %A Gibney,Sarah %A Lyles,Courtney R %A Lucas,Antonia %A Nutbeam,Don %A Yardley,Lucy %+ Department of Psychology, Faculty of Social and Human Sciences, University of Southampton, Highfield Campus, Highfield, Southampton, SO17 1BJ, United Kingdom, 44 02380 592581, I.Muller@soton.ac.uk %K health literacy, digital intervention, diabetes, qualitative, physical activity %D 2015 %7 12.10.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Low health literacy is associated with poor health-related knowledge, illness self-management, health service use, health, and survival, and thus addressing issues related to low health literacy has been highlighted as a pressing international priority. Objective: To explore views of a digital health promotion intervention designed to be accessible to people with lower levels of health literacy, in particular examining reactions to the interactive and audiovisual elements of the intervention. Methods: Qualitative think-aloud interviews were carried out with 65 adults with type 2 diabetes in the UK, Ireland, USA, Germany, and Austria, with purposive sampling to ensure representation of people with lower levels of health literacy. Inductive thematic analysis was used to identify common themes. We then systematically compared views in subgroups based on country, health literacy level, age, gender, and time since diagnosis. Results: Most participants from the chosen countries expressed positive views of most elements and features of the intervention. Some interactive and audiovisual elements required modification to increase their usability and perceived credibility and relevance. There were some differences in views based on age and gender, but very few differences relating to health literacy level or time since diagnosis. Conclusions: In general, participants found the intervention content and format accessible, appropriate, engaging, and motivating. Digital interventions can and should be designed to be accessible and engaging for people with a wide range of health literacy levels. %M 26459743 %R 10.2196/jmir.4999 %U http://www.jmir.org/2015/10/e230/ %U https://doi.org/10.2196/jmir.4999 %U http://www.ncbi.nlm.nih.gov/pubmed/26459743 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 4 %P e120 %T An Internet-Based Intervention (Mamma Mia) for Postpartum Depression: Mapping the Development from Theory to Practice %A Drozd,Filip %A Haga,Silje Marie %A Brendryen,Håvar %A Slinning,Kari %+ National Network for Infant Mental Health, Centre for Child and Adolescent Mental Health, Eastern and Southern Norway, PO Box 4623 Nydalen, Oslo, N-0405, Norway, 47 975 16 188, filip.drozd@r-bup.no %K early intervention %K Internet %K intervention mapping %K Mamma Mia %K postpartum depression %K pregnancy %K well-being %D 2015 %7 12.10.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: As much as 10-15% of new mothers experience depression postpartum. An Internet-based intervention (Mamma Mia) was developed with the primary aims of preventing depressive symptoms and enhancing subjective well-being among pregnant and postpartum women. A secondary aim of Mamma Mia was to ease the transition of becoming a mother by providing knowledge, techniques, and support during pregnancy and after birth. Objective: The aim of the paper is to provide a systematic and comprehensive description of the intervention rationale and the development of Mamma Mia. Methods: For this purpose, we used the intervention mapping (IM) protocol as descriptive tool, which consists of the following 6 steps: (1) a needs assessment, (2) definition of change objectives, (3) selection of theoretical methods and practical strategies, (4) development of program components, (5) planning adoption and implementation, and (6) planning evaluation. Results: Mamma Mia is a fully automated Internet intervention available for computers, tablets, and smartphones, intended for individual use by the mother. It starts in gestational week 18-24 and lasts up to when the baby becomes 6 months old. This intervention applies a tunneled design to guide the woman through the program in a step-by-step fashion in accordance with the psychological preparations of becoming a mother. The intervention is delivered by email and interactive websites, combining text, pictures, prerecorded audio files, and user input. It targets risk and protective factors for postpartum depression such as prepartum and postpartum attachment, couple satisfaction, social support, and subjective well-being, as identified in the needs assessment. The plan is to implement Mamma Mia directly to users and as part of ordinary services at well-baby clinics, and to evaluate the effectiveness of Mamma Mia in a randomized controlled trial and assess users’ experiences with the program. Conclusions: The IM of Mamma Mia has made clear the rationale for the intervention, and linked theories and empirical evidence to the contents and materials of the program. This meets the recent calls for intervention descriptions and may inform future studies, development of interventions, and systematic reviews. %M 26476481 %R 10.2196/resprot.4858 %U http://www.researchprotocols.org/2015/4/e120/ %U https://doi.org/10.2196/resprot.4858 %U http://www.ncbi.nlm.nih.gov/pubmed/26476481 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 10 %P e228 %T Impact of Educational Level on Study Attrition and Evaluation of Web-Based Computer-Tailored Interventions: Results From Seven Randomized Controlled Trials %A Reinwand,Dominique A %A Crutzen,Rik %A Elfeddali,Iman %A Schneider,Francine %A Schulz,Daniela Nadine %A Smit,Eline Suzanne %A Stanczyk,Nicola Esther %A Tange,Huibert %A Voncken-Brewster,Viola %A Walthouwer,Michel Jean Louis %A Hoving,Ciska %A de Vries,Hein %+ CAPHRI, Department of Health Promotion, Maastricht University, P. O. Box 616, Maastricht, MD 6200, Netherlands, 31 433882435, d.reinwand@maastrichtuniversity.nl %K dropout %K attrition %K educational level %K computer tailoring %K Web-based intervention %K eHealth %K evaluation %K meta-analysis %D 2015 %7 07.10.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based computer-tailored interventions have shown to be effective in improving health behavior; however, high dropout attrition is a major issue in these interventions. Objective: The aim of this study is to assess whether people with a lower educational level drop out from studies more frequently compared to people with a higher educational level and to what extent this depends on evaluation of these interventions. Methods: Data from 7 randomized controlled trials of Web-based computer-tailored interventions were used to investigate dropout rates among participants with different educational levels. To be able to compare higher and lower educated participants, intervention evaluation was assessed by pooling data from these studies. Logistic regression analysis was used to assess whether intervention evaluation predicted dropout at follow-up measurements. Results: In 3 studies, we found a higher study dropout attrition rate among participants with a lower educational level, whereas in 2 studies we found that middle educated participants had a higher dropout attrition rate compared to highly educated participants. In 4 studies, no such significant difference was found. Three of 7 studies showed that participants with a lower or middle educational level evaluated the interventions significantly better than highly educated participants (“Alcohol-Everything within the Limit”: F2,376=5.97, P=.003; “My Healthy Behavior”: F2,359=5.52, P=.004; “Master Your Breath”: F2,317=3.17, P=.04). One study found lower intervention evaluation by lower educated participants compared to participants with a middle educational level (“Weight in Balance”: F2,37=3.17, P=.05). Low evaluation of the interventions was not a significant predictor of dropout at a later follow-up measurement in any of the studies. Conclusions: Dropout attrition rates were higher among participants with a lower or middle educational level compared with highly educated participants. Although lower educated participants evaluated the interventions better in approximately half of the studies, evaluation did not predict dropout attrition. Further research is needed to find other explanations for high dropout rates among lower educated participants. %M 26446779 %R 10.2196/jmir.4941 %U http://www.jmir.org/2015/10/e228/ %U https://doi.org/10.2196/jmir.4941 %U http://www.ncbi.nlm.nih.gov/pubmed/26446779 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 10 %P e227 %T Parent Engagement With a Telehealth-Based Parent-Mediated Intervention Program for Children With Autism Spectrum Disorders: Predictors of Program Use and Parent Outcomes %A Ingersoll,Brooke %A Berger,Natalie I %+ Department of Psychology, Michigan State University, 316 Physics Rd, Michigan State University, East Lansing, MI, 48824, United States, 1 517 432 8412, ingers19@msu.edu %K autism %K telehealth %K parent training %D 2015 %7 06.10.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: There has been growing interest in using telehealth to increase access to parent-mediated interventions for children with ASD. However, little is known about how parents engage with such programs. Objective: This paper presents program engagement data from a pilot study comparing self-directed and therapist-assisted versions of a novel telehealth-based parent-mediated intervention for young children with autism spectrum disorders (ASD). Methods: Parents of young children with ASD were randomly assigned to receive a self-directed or therapist-assisted version of ImPACT Online. Parent engagement and satisfaction with the different components of the program website were examined using the program’s automated data collection and a post-treatment evaluation survey. We examined the relationship between program engagement and changes in parent knowledge and implementation and participant characteristics associated with program engagement. Results: Of the 27 parent participants, the majority were female (26/27, 96%), married (22/27, 81%), with a college degree or higher (15/27, 56%), and less than half were not employed outside of the home (10/27, 37%). The mean chronological age of the child participants was 43.26 months, and the majority were male (19/27, 70%) and white (21/27, 78%). Most of the families (19/27, 70%) resided in a rural or medically underserved area. Parents logged into the website an average of 46.85 times, spent an average of 964.70 minutes on the site, and completed an average of 90.17% of the lesson learning activities. Participants in the therapist-assisted group were more likely to engage with the website than those in the self-directed group: F2,24=17.65, P<.001. In total, 85% of participants completed the program, with a significantly greater completion rate in the therapist-assisted group (N=27): χ21=5.06, P=.03. Lesson learning activities were visited significantly more often than the supplemental activities (all Ps<.05). Multiple regression controlling for pretreatment performance indicated that program completion (beta=.51, P=.02) predicted post-treatment intervention knowledge, and program completion (beta=.43, P=.03) and group assignment (beta=-.37, P=.045) predicted post-treatment intervention fidelity. Partial correlations indicated that parent depressive symptoms at pretreatment were negatively associated with program completion (r=-.40, P=.04), but other key parent and child demographic factors were not. Post-treatment measures of website usability (r=.65, P<.001), treatment acceptability (r=.58, P=.002), and overall satisfaction (r=.58, P=.002) were all related to program completion. Conclusions: Parent engagement and satisfaction with ImPACT Online was high for both self-directed and therapist-assisted versions of the program, although therapist assistance increased engagement. Program completion was associated with parent outcomes, providing support for the role of the website in parent learning. This program has the potential to increase access to parent-mediated intervention for families of children with ASD. %M 26443557 %R 10.2196/jmir.4913 %U http://www.jmir.org/2015/10/e227/ %U https://doi.org/10.2196/jmir.4913 %U http://www.ncbi.nlm.nih.gov/pubmed/26443557 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 10 %P e224 %T Health Coaching Reduces HbA1c in Type 2 Diabetic Patients From a Lower-Socioeconomic Status Community: A Randomized Controlled Trial %A Wayne,Noah %A Perez,Daniel F %A Kaplan,David M %A Ritvo,Paul %+ School of Kinesiology & Health Science, Faculty of Health, York University, 357 Bethune College, 4700 Keele Street, Toronto, ON, M3J1P3, Canada, 1 416 736 2100 ext 22396, pritvo@yorku.ca %K diabetes mellitus, type 2 %K health coaching %K mHealth %K telehealth %K randomized controlled trial %K RCT %D 2015 %7 05.10.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Adoptions of health behaviors are crucial for maintaining good health after type 2 diabetes mellitus (T2DM) diagnoses. However, adherence to glucoregulating behaviors like regular exercise and balanced diet can be challenging, especially for people living in lower-socioeconomic status (SES) communities. Providing cost-effective interventions that improve self-management is important for improving quality of life and the sustainability of health care systems. Objective: To evaluate a health coach intervention with and without the use of mobile phones to support health behavior change in patients with type 2 diabetes. Methods: In this noninferiority, pragmatic randomized controlled trial (RCT), patients from two primary care health centers in Toronto, Canada, with type 2 diabetes and a glycated hemoglobin/hemoglobin A1c (HbA1c) level of ≥7.3% (56.3 mmol/mol) were randomized to receive 6 months of health coaching with or without mobile phone monitoring support. We hypothesized that both approaches would result in significant HbA1c reductions, although health coaching with mobile phone monitoring would result in significantly larger effects. Participants were evaluated at baseline, 3 months, and 6 months. The primary outcome was the change in HbA1c from baseline to 6 months (difference between and within groups). Other outcomes included weight, waist circumference, body mass index (BMI), satisfaction with life, depression and anxiety (Hospital Anxiety and Depression Scale [HADS]), positive and negative affect (Positive and Negative Affect Schedule [PANAS]), and quality of life (Short Form Health Survey-12 [SF-12]). Results: A total of 138 patients were randomized and 7 were excluded for a substudy; of the remaining 131, 67 were allocated to the intervention group and 64 to the control group. Primary outcome data were available for 97 participants (74.0%). While both groups reduced their HbA1c levels, there were no significant between-group differences in change of HbA1c at 6 months using intention-to-treat (last observation carried forward [LOCF]) (P=.48) or per-protocol (P=.83) principles. However, the intervention group did achieve an accelerated HbA1c reduction, leading to a significant between-group difference at 3 months (P=.03). This difference was reduced at the 6-month follow-up as the control group continued to improve, achieving a reduction of 0.81% (8.9 mmol/mol) (P=.001) compared with a reduction of 0.84% (9.2 mmol/mol)(P=.001) in the intervention group. Intervention group participants also had significant decreases in weight (P=.006) and waist circumference (P=.01) while controls did not. Both groups reported improvements in mood, satisfaction with life, and quality of life. Conclusions: Health coaching with and without access to mobile technology appeared to improve glucoregulation and mental health in a lower-SES, T2DM population. The accelerated improvement in the mobile phone group suggests the connectivity provided may more quickly improve adoption and adherence to health behaviors within a clinical diabetes management program. Overall, health coaching in primary care appears to lead to significant benefits for patients from lower-SES communities with poorly controlled type 2 diabetes. Trial Registration: ClinicalTrials.gov NCT02036892; http://clinicaltrials.gov/ct2/show/NCT02036892 (Archived by WebCite at http://www.webcitation.org/6b3cJYJOD) %M 26441467 %R 10.2196/jmir.4871 %U http://www.jmir.org/2015/10/e224/ %U https://doi.org/10.2196/jmir.4871 %U http://www.ncbi.nlm.nih.gov/pubmed/26441467 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 9 %P e222 %T Use and Effectiveness of a Video- and Text-Driven Web-Based Computer-Tailored Intervention: Randomized Controlled Trial %A Walthouwer,Michel Jean Louis %A Oenema,Anke %A Lechner,Lilian %A de Vries,Hein %+ Maastricht University, Department of Health Promotion, Peter Debyeplein 1, Maastricht, 6229 HA, Netherlands, 31 433882402, michel.walthouwer@maastrichtuniversity.nl %K intervention use %K Web-based %K computer tailoring %K obesity %K educational level %K delivery strategy %K matching %D 2015 %7 25.09.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Many Web-based computer-tailored interventions are characterized by high dropout rates, which limit their potential impact. Objective: This study had 4 aims: (1) examining if the use of a Web-based computer-tailored obesity prevention intervention can be increased by using videos as the delivery format, (2) examining if the delivery of intervention content via participants’ preferred delivery format can increase intervention use, (3) examining if intervention effects are moderated by intervention use and matching or mismatching intervention delivery format preference, (4) and identifying which sociodemographic factors and intervention appreciation variables predict intervention use. Methods: Data were used from a randomized controlled study into the efficacy of a video and text version of a Web-based computer-tailored obesity prevention intervention consisting of a baseline measurement and a 6-month follow-up measurement. The intervention consisted of 6 weekly sessions and could be used for 3 months. ANCOVAs were conducted to assess differences in use between the video and text version and between participants allocated to a matching and mismatching intervention delivery format. Potential moderation by intervention use and matching/mismatching delivery format on self-reported body mass index (BMI), physical activity, and energy intake was examined using regression analyses with interaction terms. Finally, regression analysis was performed to assess determinants of intervention use. Results: In total, 1419 participants completed the baseline questionnaire (follow-up response=71.53%, 1015/1419). Intervention use declined rapidly over time; the first 2 intervention sessions were completed by approximately half of the participants and only 10.9% (104/956) of the study population completed all 6 sessions of the intervention. There were no significant differences in use between the video and text version. Intervention use was significantly higher among participants who were allocated to an intervention condition that matched their preferred intervention delivery format. There were no significant interaction terms for any of the outcome variables; a match and more intervention use did not result in better intervention effects. Participants with a high BMI and participants who felt involved and supported by the intervention were more likely to use the intervention more often. Conclusions: Video delivery of tailored feedback does not increase the use of Web-based computer-tailored interventions. However, intervention use can potentially be increased by delivering intervention content via participants’ preferred intervention delivery format and creating feelings of relatedness. Because more intervention use was not associated with better intervention outcomes, more research is needed to examine the optimum number of intervention sessions in terms of maximizing use and effects. Trial Registration: Nederlands Trial Register: NTR3501; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3501 (Archived by WebCite at http://www.webcitation.org/6b2tsH8Pk) %M 26408488 %R 10.2196/jmir.4496 %U http://www.jmir.org/2015/9/e222/ %U https://doi.org/10.2196/jmir.4496 %U http://www.ncbi.nlm.nih.gov/pubmed/26408488 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 9 %P e214 %T Adherence to Technology-Mediated Insomnia Treatment: A Meta-Analysis, Interviews, and Focus Groups %A Horsch,Corine %A Lancee,Jaap %A Beun,Robbert Jan %A Neerincx,Mark A %A Brinkman,Willem-Paul %+ Interactive Intelligence, Delft University of Technology, EWI HB, 12th Floor, Mekelweg 4, Delft, 2628 CD, Netherlands, 31 152784145, c.h.g.horsch@tudelft.nl %K sleep initiation and maintenance disorders %K patient compliance %K meta-analysis %K interview %K focus groups %K mobile apps %K user-computer interface %D 2015 %7 04.09.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Several technologies have been proposed to support the reduction of insomnia complaints. A user-centered assessment of these technologies could provide insight into underlying factors related to treatment adherence. Objective: Gaining insight into adherence to technology-mediated insomnia treatment as a solid base for improving those adherence rates by applying adherence-enhancing strategies. Methods: Adherence to technology-mediated sleep products was studied in three ways. First, a meta-analysis was performed to investigate adherence rates in technology-mediated insomnia therapy. Several databases were queried for technology-mediated insomnia treatments. After inclusion and exclusion steps, data from 18 studies were retrieved and aggregated to find an average adherence rate. Next, 15 semistructured interviews about sleep-support technologies were conducted to investigate perceived adherence. Lastly, several scenarios were written about the usage of a virtual sleep coach that could support adherence rates. The scenarios were discussed in six different focus groups consisting of potential users (n=15), sleep experts (n=7), and coaches (n=9). Results: From the meta-analysis, average treatment adherence appeared to be approximately 52% (95% CI 43%-61%) for technology-mediated insomnia treatments. This means that, on average, half of the treatment exercises were not executed, suggesting there is a substantial need for adherence and room for improvement in this area. However, the users in the interviews believed they adhered quite well to their sleep products. Users mentioned relying on personal commitment (ie, willpower) for therapy adherence. Participants of the focus groups reconfirmed their belief in the effectiveness of personal commitment, which they regarded as more effective than adherence-enhancing strategies. Conclusions: Although adherence rates for insomnia interventions indicate extensive room for improvement, users might not consider adherence to be a problem; they believe willpower to be an effective adherence strategy. A virtual coach should be able to cope with this “adherence bias” and persuade users to accept adherence-enhancing strategies, such as reminders, compliments, and community building. %M 26341671 %R 10.2196/jmir.4115 %U http://www.jmir.org/2015/9/e214/ %U https://doi.org/10.2196/jmir.4115 %U http://www.ncbi.nlm.nih.gov/pubmed/26341671 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 9 %P e197 %T Predictors of Response to Web-Based Cognitive Behavioral Therapy With High-Intensity Face-to-Face Therapist Guidance for Depression: A Bayesian Analysis %A Høifødt,Ragnhild Sørensen %A Mittner,Matthias %A Lillevoll,Kjersti %A Katla,Susanne Kvam %A Kolstrup,Nils %A Eisemann,Martin %A Friborg,Oddgeir %A Waterloo,Knut %+ Department of Psychology, Faculty of Health Sciences, UiT The Arctic University of Norway, 9037 Tromsø, Tromsø, 9037, Norway, 47 776 49230, ragnhild.s.hoifodt@uit.no %K treatment outcome %K computer-assisted therapy %K cognitive behavior therapy %K depression %K primary health care %K Bayesian analysis %D 2015 %7 02.09.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Several studies have demonstrated the effect of guided Internet-based cognitive behavioral therapy (ICBT) for depression. However, ICBT is not suitable for all depressed patients and there is a considerable level of nonresponse. Research on predictors and moderators of outcome in ICBT is inconclusive. Objective: This paper explored predictors of response to an intervention combining the Web-based program MoodGYM and face-to-face therapist guidance in a sample of primary care patients with mild to moderate depressive symptoms. Methods: Participants (N=106) aged between 18 and 65 years were recruited from primary care and randomly allocated to a treatment condition or to a delayed treatment condition. The intervention included the Norwegian version of the MoodGYM program, face-to-face guidance from a psychologist, and reminder emails. In this paper, data from the treatment phase of the 2 groups was merged to increase the sample size (n=82). Outcome was improvement in depressive symptoms during treatment as assessed with the Beck Depression Inventory-II (BDI-II). Predictors included demographic variables, severity variables (eg, number of depressive episodes and pretreatment depression and anxiety severity), cognitive variables (eg, dysfunctional thinking), module completion, and treatment expectancy and motivation. Using Bayesian analysis, predictors of response were explored with a latent-class approach and by analyzing whether predictors affected the slope of response. Results: A 2-class model distinguished well between responders (74%, 61/82) and nonresponders (26%, 21/82). Our results indicate that having had more depressive episodes, being married or cohabiting, and scoring higher on a measure of life satisfaction had high odds for positively affecting the probability of response. Higher levels of dysfunctional thinking had high odds for a negative effect on the probability of responding. Prediction of the slope of response yielded largely similar results. Bayes factors indicated substantial evidence that being married or cohabiting predicted a more positive treatment response. The effects of life satisfaction and number of depressive episodes were more uncertain. There was substantial evidence that several variables were unrelated to treatment response, including gender, age, and pretreatment symptoms of depression and anxiety. Conclusions: Treatment response to ICBT with face-to-face guidance may be comparable across varying levels of depressive severity and irrespective of the presence and severity of comorbid anxiety. Being married or cohabiting, reporting higher life satisfaction, and having had more depressive episodes may predict a more favorable response, whereas higher levels of dysfunctional thinking may be a predictor of poorer response. More studies exploring predictors and moderators of Internet-based treatments are needed to inform for whom this treatment is most effective. Trial Registration: Australian New Zealand Clinical Trials Registry number: ACTRN12610000257066; https://www.anzctr.org.au/trial_view.aspx?id=335255 (Archived by WebCite at http://www.webcitation.org/6GR48iZH4). %M 26333818 %R 10.2196/jmir.4351 %U http://www.jmir.org/2015/9/e197/ %U https://doi.org/10.2196/jmir.4351 %U http://www.ncbi.nlm.nih.gov/pubmed/26333818 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 8 %P e210 %T Apps for IMproving FITness and Increasing Physical Activity Among Young People: The AIMFIT Pragmatic Randomized Controlled Trial %A Direito,Artur %A Jiang,Yannan %A Whittaker,Robyn %A Maddison,Ralph %+ Faculty of Medical and Health Sciences, National Institute for Health Innovation, University of Auckland, National Institute for Health Innovation, School of Population Health, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland, 1142, New Zealand, 64 9 373 7599 ext 85285, a.direito@auckland.ac.nz %K physical fitness %K motor activity %K exercise %K physical activity %K adolescent %K health promotion %K telemedicine %K mHealth %K mobile applications %K smartphone %D 2015 %7 27.08.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Given the global prevalence of insufficient physical activity (PA), effective interventions that attenuate age-related decline in PA levels are needed. Mobile phone interventions that positively affect health (mHealth) show promise; however, their impact on PA levels and fitness in young people is unclear and little is known about what makes a good mHealth app. Objective: The aim was to determine the effects of two commercially available smartphone apps (Zombies, Run and Get Running) on cardiorespiratory fitness and PA levels in insufficiently active healthy young people. A second aim was to identify the features of the app design that may contribute to improved fitness and PA levels. Methods: Apps for IMproving FITness (AIMFIT) was a 3-arm, parallel, randomized controlled trial conducted in Auckland, New Zealand. Participants were recruited through advertisements in electronic mailing lists, local newspapers, flyers posted in community locations, and presentations at schools. Eligible young people aged 14-17 years were allocated at random to 1 of 3 conditions: (1) use of an immersive app (Zombies, Run), (2) use of a nonimmersive app (Get Running), or (3) usual behavior (control). Both smartphone apps consisted of a fully automated 8-week training program designed to improve fitness and ability to run 5 km; however, the immersive app featured a game-themed design and narrative. Intention-to-treat analysis was performed using data collected face-to-face at baseline and 8 weeks, and all regression models were adjusted for baseline outcome value and gender. The primary outcome was cardiorespiratory fitness, objectively assessed as time to complete the 1-mile run/walk test at 8 weeks. Secondary outcomes were PA levels (accelerometry and self-reported), enjoyment, psychological need satisfaction, self-efficacy, and acceptability and usability of the apps. Results: A total of 51 participants were randomized to the immersive app intervention (n=17), nonimmersive app intervention (n=16), or the control group (n=18). The mean age of participants was 15.7 (SD 1.2) years; participants were mostly NZ Europeans (61%, 31/51) and 57% (29/51) were female. Overall retention rate was 96% (49/51). There was no significant intervention effect on the primary outcome using either of the apps. Compared to the control, time to complete the fitness test was –28.4 seconds shorter (95% CI –66.5 to 9.82, P=.20) for the immersive app group and –24.7 seconds (95% CI –63.5 to 14.2, P=.32) for the nonimmersive app group. No significant intervention effects were found for secondary outcomes. Conclusions: Although apps have the ability to increase reach at a low cost, our pragmatic approach using readily available commercial apps as a stand-alone instrument did not have a significant effect on fitness. However, interest in future use of PA apps is promising and highlights a potentially important role of these tools in a multifaceted approach to increase fitness, promote PA, and consequently reduce the adverse health outcomes associated with insufficient activity. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12613001030763; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12613001030763 (Archived by WebCite at http://www.webcitation.org/6aasfJVTJ). %M 26316499 %R 10.2196/jmir.4568 %U http://www.jmir.org/2015/8/e210/ %U https://doi.org/10.2196/jmir.4568 %U http://www.ncbi.nlm.nih.gov/pubmed/26316499 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 8 %P e206 %T An Interactive Computer Session to Initiate Physical Activity in Sedentary Cardiac Patients: Randomized Controlled Trial %A Almeida,Fabio A %A Smith-Ray,Renae L %A Dzewaltowski,David A %A Glasgow,Russell E %A Lee,Rebecca E %A Thomas,Deborah SK %A Xu,Stanley %A Estabrooks,Paul A %+ Implementation and Systems Science Laboratory, Department of Human, Nutrition, Foods, and Exercise, Virginia Tech, Suite #104, 1 Riverside Circle SW, Roanoke, VA, 24073, United States, 1 540 231 6198, falmeida@vt.edu %K exercise, physical %K treadmill test %K human computer interaction %K behavioral research %K cardiovascular diseases %K interactive media %D 2015 %7 24.08.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Physical activity (PA) improves many facets of health. Despite this, the majority of American adults are insufficiently active. Adults who visit a physician complaining of chest pain and related cardiovascular symptoms are often referred for further testing. However, when this testing does not reveal an underlying disease or pathology, patients typically receive no additional standard care services. A PA intervention delivered within the clinic setting may be an effective strategy for improving the health of this population at a time when they may be motivated to take preventive action. Objective: Our aim was to determine the effectiveness of a tailored, computer-based, interactive personal action planning session to initiate PA among a group of sedentary cardiac patients following exercise treadmill testing (ETT). Methods: This study was part of a larger 2x2 randomized controlled trial to determine the impact of environmental and social-cognitive intervention approaches on the initiation and maintenance of weekly PA for patients post ETT. Participants who were referred to an ETT center but had a negative-test (ie, stress tests results indicated no apparent cardiac issues) were randomized to one of four treatment arms: (1) increased environmental accessibility to PA resources via the provision of a free voucher to a fitness facility in close proximity to their home or workplace (ENV), (2) a tailored social cognitive intervention (SC) using a “5 As”-based (ask, advise, assess, assist, and arrange) personal action planning tool, (3) combined intervention of both ENV and SC approaches (COMBO), or (4) a matched contact nutrition control (CON). Each intervention was delivered using a computer-based interactive session. A general linear model for repeated measures was conducted with change in PA behavior from baseline to 1-month post interactive computer session as the primary outcome. Results: Sedentary participants (n=452; 34.7% participation rate) without a gym membership (mean age 58.57 years; 59% female, 78% white, 12% black, 11% Hispanic) completed a baseline assessment and an interactive computer session. PA increased across the study sample (F1,441=30.03, P<.001). However, a time by condition interaction (F3,441=8.33, P<.001) followed by post hoc analyses indicated that SC participants exhibited a significant increase in weekly PA participation (mean 45.1, SD 10.2) compared to CON (mean -2.5, SD 10.8, P=.004) and ENV (mean 8.3, SD 8.1, P<.05). Additionally, COMBO participants exhibited a significant increase in weekly PA participation (mean 53.4, SD 8.9) compared to CON (P<.001) and ENV (P=.003) participants. There were no significant differences between ENV and CON or between SC and COMBO. Conclusions: A brief, computer-based, interactive personal action planning session may be an effective tool to initiate PA within a health care setting, in particular as part of the ETT system. Trial Registration: Clinicaltrials.gov NCT00432133, http://clinicaltrials.gov/ct2/show/NCT00432133 (Archived by WebCite at http://www.webcitation.org/6aa8X3mw1). %M 26303347 %R 10.2196/jmir.3759 %U http://www.jmir.org/2015/8/e206/ %U https://doi.org/10.2196/jmir.3759 %U http://www.ncbi.nlm.nih.gov/pubmed/26303347 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 3 %P e105 %T Efficacy of a Multicomponent Positive Psychology Self-Help Intervention: Study Protocol of a Randomized Controlled Trial %A Schotanus-Dijkstra,Marijke %A Drossaert,Constance HC %A Pieterse,Marcel E %A Walburg,Jan A %A Bohlmeijer,Ernst T %+ Trimbos Institute, Netherlands Institute of Mental Health and Addiction, PO Box 725, Utrecht, 3500 AS, Netherlands, 31 302959383, m.schotanus@utwente.nl %K well-being %K flourishing %K mental-health promotion %K positive psychology %K self-help %K email support %D 2015 %7 20.08.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Positive psychology interventions have been found to enhance well-being and decrease clinical symptomatology. However, it is still unknown how flourishing can also be increased. Although multicomponent interventions seem to be necessary for this purpose, different formats can be used. A cost-effective approach could be a positive psychology-based self-help book with tailored email support to reach large target groups and to prevent dropout. Objective: This study will evaluate the efficacy of a comprehensive multicomponent self-help intervention with or without email support on well-being and flourishing, and will seek to determine the working mechanisms underlying the intervention. Methods: In this 3-armed, parallel, randomized controlled trial, 396 participants with low or moderate levels of well-being and without clinical symptomatology will be randomly assigned to (1) a self-help book condition with weekly email support, (2) a self-help book condition without email support but with a weekly information email, or (3) a waiting list control condition. Online measurements will be assessed at baseline, at post-test (3 months after baseline), and at 6 and 12 months after baseline. Results: The primary outcomes are well-being and flourishing (ie, high levels of well-being). Secondary outcomes are the well-being components included in the intervention: positive emotion, use of strengths, optimism, self-compassion, resilience, and positive relations. Other measures include depressive and anxiety symptoms, personality traits, direct medical and non-medical costs, life-events, and client satisfaction. Conclusions: This study will add knowledge to the efficacy and cost-effectiveness of a multicomponent positive psychology intervention. We will also explore who can benefit most from this intervention. If the intervention is found to be effective, our results will be especially relevant for public mental health services, governments, and primary care. Trial Registration: The Netherlands Trial Register NTR4297; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4297 (Archived by WebCite at http://webcitation.org/6Uwb5SUUM). %M 26293678 %R 10.2196/resprot.4162 %U http://www.researchprotocols.org/2015/3/e105/ %U https://doi.org/10.2196/resprot.4162 %U http://www.ncbi.nlm.nih.gov/pubmed/26293678 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 8 %P e195 %T Mobile Exercise Apps and Increased Leisure Time Exercise Activity: A Moderated Mediation Analysis of the Role of Self-Efficacy and Barriers %A Litman,Leib %A Rosen,Zohn %A Spierer,David %A Weinberger-Litman,Sarah %A Goldschein,Akiva %A Robinson,Jonathan %+ Lander College, Psychology Department, 75-31 150th Street, Kew Gardens Hills, NY, NY, 11367, United States, 1 917 8367941, leib.litman@touro.edu %K mobile health %K apps %K exercise %K barriers to exercise %K self-efficacy %K BMI %D 2015 %7 14.8.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: There are currently over 1000 exercise apps for mobile devices on the market. These apps employ a range of features, from tracking exercise activity to providing motivational messages. However, virtually nothing is known about whether exercise apps improve exercise levels and health outcomes and, if so, the mechanisms of these effects. Objective: Our aim was to examine whether the use of exercise apps is associated with increased levels of exercise and improved health outcomes. We also develop a framework within which to understand how exercise apps may affect health and test multiple models of possible mechanisms of action and boundary conditions of these relationships. Within this framework, app use may increase physical activity by influencing variables such as self-efficacy and may help to overcome exercise barriers, leading to improved health outcomes such as lower body mass index (BMI). Methods: In this study, 726 participants with one of three backgrounds were surveyed about their use of exercise apps and health: (1) those who never used exercise apps, (2) those who used exercise apps but discontinued use, and (3) those who are currently using exercise apps. Participants were asked about their long-term levels of exercise and about their levels of exercise during the previous week with the International Physical Activity Questionnaire (IPAQ). Results: Nearly three-quarters of current app users reported being more active compared to under half of non-users and past users. The IPAQ showed that current users had higher total leisure time metabolic equivalent of task (MET) expenditures (1169 METs), including walking and vigorous exercise, compared to those who stopped using their apps (612 METs) or who never used apps (577 METs). Importantly, physical activity levels in domains other than leisure time activity were similar across the groups. The results also showed that current users had lower BMI (25.16) than past users (26.8) and non-users (26.9) and that this association was mediated by exercise levels and self-efficacy. That relationship was also moderated by perceived barriers to exercise. Multiple serial mediation models were tested, which revealed that the association between app use and BMI is mediated by increased self-efficacy and increased exercise. Conclusions: Exercise app users are more likely to exercise during their leisure time, compared to those who do not use exercise apps, essentially fulfilling the role that many of these apps were designed to accomplish. Data also suggest that one way that exercise apps may increase exercise levels and health outcomes such as BMI is by making it easier for users to overcome barriers to exercise, leading to increased self-efficacy. We discuss ways of improving the effectiveness of apps by incorporating theory-driven approaches. We conclude that exercise apps can be viewed as intervention delivery systems consisting of features that help users overcome specific barriers. %M 26276227 %R 10.2196/jmir.4142 %U http://www.jmir.org/2015/8/e195/ %U https://doi.org/10.2196/jmir.4142 %U http://www.ncbi.nlm.nih.gov/pubmed/26276227 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 8 %P e190 %T “If I Were Nick”: Men’s Responses to an Interactive Video Drama Series to Support Smoking Cessation %A Bottorff,Joan L %A Sarbit,Gayl %A Oliffe,John L %A Kelly,Mary T %A Lohan,Maria %A Stolp,Sean %A Sharp,Paul %+ School of Nursing, Faculty of Health and Social Development, University of British Columbia, 1147 University Road, Art 223, Kelowna, BC, V1V 1V7, Canada, 1 2508078627, joan.bottorff@ubc.ca %K smoking cessation %K tobacco use %K technology %K interactive video drama %K self-efficacy %D 2015 %7 10.08.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Men continue to smoke in greater numbers than women; however, few interventions have been developed and tested to support men’s cessation. Men tend to rely on quitting strategies associated with stereotypical manliness, such as willpower, stoicism, and independence, but they may lack the self-efficacy skills required to sustain a quit. In this paper, we describe the development of and reception to an interactive video drama (IVD) series, composed of 7 brief scenarios, to support and strengthen men’s smoking cessation efforts. The value of IVD in health promotion is predicated on the evidence that viewers engage with the material when they are presented characters with whom they can personally identify. The video dramatizes the challenges unfolding in the life of the main character, Nick, on the first day of his quit and models the skills necessary to embark upon a sustainable quit. Objective: The objective was to describe men’s responses to the If I were Nick IVD series as part of a study of QuitNow Men, an innovative smoking cessation website designed for men. Specific objectives were to explore the resonance of the main character of the IVD series with end-users and explore men’s perceptions of the effectiveness of the IVD series for supporting their quit self-management. Methods: Seven brief IVD scenarios were developed, filmed with a professional actor, and uploaded to a new online smoking cessation website, QuitNow Men. A sample of 117 men who smoked were recruited into the study and provided baseline data prior to access to the QuitNow Men website for a 6-month period. During this time, 47 men chose to view the IVDs. Their responses to questions about the IVDs were collected in online surveys at 3-month and 6-month time points and analyzed using descriptive statistics. Results: The majority of participants indicated they related to the main character, Nick. Participants who “strongly agreed” they could relate to Nick perceived significantly higher levels of support from the IVDs than the “neutral” and “disagree” groups (P<.001, d=2.0, P<.001, d=3.1). The “agree” and “neutral” groups were significantly higher on rated support from the videos than the “disagree” (P<.001, d=2.2, P=.01, d=1.5). Participants’ perception of the main character was independent of participant age, education attainment, or previous quit attempts. Conclusions: The findings suggest that IVD interventions may be an important addition to men’s smoking cessation programs. Given that the use of IVD scenarios in health promotion is in its infancy, the positive outcomes from this study signal the potential for IVD and warrant ongoing evaluation in smoking cessation and, more generally, men’s health promotion. %M 26265410 %R 10.2196/jmir.4491 %U http://www.jmir.org/2015/8/e190/ %U https://doi.org/10.2196/jmir.4491 %U http://www.ncbi.nlm.nih.gov/pubmed/26265410 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 8 %P e192 %T Technologies That Assess the Location of Physical Activity and Sedentary Behavior: A Systematic Review %A Loveday,Adam %A Sherar,Lauren B %A Sanders,James P %A Sanderson,Paul W %A Esliger,Dale W %+ National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Epinal Way, Loughborough, LE11 3TU, United Kingdom, 44 7920015099, a.loveday@lboro.ac.uk %K wearable camera %K global positioning system %K real-time locating system %K sitting %K context %D 2015 %7 05.08.2015 %9 Review %J J Med Internet Res %G English %X Background: The location in which physical activity and sedentary behavior are performed can provide valuable behavioral information, both in isolation and synergistically with other areas of physical activity and sedentary behavior research. Global positioning systems (GPS) have been used in physical activity research to identify outdoor location; however, while GPS can receive signals in certain indoor environments, it is not able to provide room- or subroom-level location. On average, adults spend a high proportion of their time indoors. A measure of indoor location would, therefore, provide valuable behavioral information. Objective: This systematic review sought to identify and critique technology which has been or could be used to assess the location of physical activity and sedentary behavior. Methods: To identify published research papers, four electronic databases were searched using key terms built around behavior, technology, and location. To be eligible for inclusion, papers were required to be published in English and describe a wearable or portable technology or device capable of measuring location. Searches were performed up to February 4, 2015. This was supplemented by backward and forward reference searching. In an attempt to include novel devices which may not yet have made their way into the published research, searches were also performed using three Internet search engines. Specialized software was used to download search results and thus mitigate the potential pitfalls of changing search algorithms. Results: A total of 188 research papers met the inclusion criteria. Global positioning systems were the most widely used location technology in the published research, followed by wearable cameras, and radio-frequency identification. Internet search engines identified 81 global positioning systems, 35 real-time locating systems, and 21 wearable cameras. Real-time locating systems determine the indoor location of a wearable tag via the known location of reference nodes. Although the type of reference node and location determination method varies between manufacturers, Wi-Fi appears to be the most popular method. Conclusions: The addition of location information to existing measures of physical activity and sedentary behavior will provide important behavioral information. %M 26245157 %R 10.2196/jmir.4761 %U http://www.jmir.org/2015/8/e192/ %U https://doi.org/10.2196/jmir.4761 %U http://www.ncbi.nlm.nih.gov/pubmed/26245157 %0 Journal Article %@ 2292-9495 %I Gunther Eysenbach %V 2 %N 2 %P e13 %T Development and Acceptability of a Co-Produced Online Intervention to Prevent Alcohol Misuse in Adolescents: A Think Aloud Study %A Davies,Emma Louise %A Martin,Jilly %A Foxcroft,David R %+ Department of Psychology, Social Work and Public Health, Oxford Brookes University, Headington Campus, Oxford, OX3 0BP, United Kingdom, 44 18654484056, edavies@brookes.ac.uk %K adolescents %K alcohol %K intervention development %K prevention %K think aloud %D 2015 %7 29.07.2015 %9 Original Paper %J JMIR Human Factors %G English %X Background: The prototype willingness model (PWM) may offer an appropriate basis for explaining and preventing adolescent alcohol misuse. An intervention was developed using a co-production approach, and consisted of an online quiz featuring 10 questions linked to the PWM. Objective: This study sought to determine the acceptability and relevance of the intervention content to young people, to incorporate their feedback into a final version. Methods: A qualitative think aloud study with follow-up semistructured interviews was undertaken with 16 young people aged 11-15 (50%). Transcripts were analyzed using thematic analysis. Results: The following 3 main themes relating the acceptability of the intervention were identified: “challenging expectations of alcohol education”; “motivations for drinking or not drinking,” and “the inevitability of drinking.” Participants found the intervention appealing because it was counter to their expectations. The content appeared to reflect their experiences of social pressure and drinking encounters. There was evidence that a focus on drinker/nondrinker prototypes was too narrow and that because adolescents perceived drinking as inevitable, it would be challenging to enact any plans to resist pressure to drink. Conclusions: An online intervention based on the PWM has the potential to engage and interest adolescents. A wide range of alcohol prototypes should be targeted and a focus on short-term harms should ensure that the intervention is credible to young people. %M 27025403 %R 10.2196/humanfactors.4452 %U http://humanfactors.jmir.org/2015/2/e13/ %U https://doi.org/10.2196/humanfactors.4452 %U http://www.ncbi.nlm.nih.gov/pubmed/27025403 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 7 %P e187 %T A Web-Based Adolescent Positive Psychology Program in Schools: Randomized Controlled Trial %A Burckhardt,Rowan %A Manicavasagar,Vijaya %A Batterham,Philip J %A Miller,Leonie M %A Talbot,Elizabeth %A Lum,Alistair %+ University of NSW and the Black Dog Institute, Black Dog Institute, Hospital Rd, Randwick, 2031, Australia, 61 293824530, r.burckhardt@unsw.edu.au %K adolescent %K Internet %K early medical intervention %K randomized controlled trial %D 2015 %7 28.07.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Adolescent mental health is characterized by relatively high rates of psychiatric disorders and low levels of help-seeking behaviors. Existing mental health programs aimed at addressing these issues in adolescents have repeated inconsistent results. Such programs have generally been based on techniques derived from cognitive behavioral therapy, which may not be ideally suited to early intervention among adolescent samples. Positive psychology, which seeks to improve well-being rather than alleviate psychological symptoms, offers an alternative approach. A previous community study of adolescents found that informal engagement in an online positive psychology program for up to 6 weeks yielded significant improvements in both well-being and depression symptoms. However, this approach had not been trialed among adolescents in a structured format and within a school setting. Objective: This study examines the feasibility of an online school-based positive psychology program delivered in a structured format over a 6-week period utilizing a workbook to guide students through website content and interactive exercises. Methods: Students from four high schools were randomly allocated by classroom to either the positive psychology condition, "Bite Back", or the control condition. The Bite Back condition consisted of positive psychology exercises and information, while the control condition used a series of non-psychology entertainment websites. Both interventions were delivered online for 6 hours over a period of 4-6 weeks during class time. Symptom measures and measures of well-being/flourishing and life satisfaction were administered at baseline and post intervention. Results: Data were analyzed using multilevel linear modeling. Both conditions demonstrated reductions in depression, stress, and total symptom scores without any significant differences between the two conditions. Both the Bite Back and control conditions also demonstrated significant improvements in life satisfaction scores post intervention. However, only the control condition demonstrated significant increases in flourishing scores post intervention. Conclusions: Results suggest that a structured online positive psychology program administered within the school curriculum was not effective when compared to the control condition. The limitations of online program delivery in school settings including logistic considerations are also relevant to the contradictory findings of this study. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN1261200057831; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362489 (Archived by Webcite at http://www.webcitation.org/6NXmjwfAy). %M 26220564 %R 10.2196/jmir.4329 %U http://www.jmir.org/2015/7/e187/ %U https://doi.org/10.2196/jmir.4329 %U http://www.ncbi.nlm.nih.gov/pubmed/26220564 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 3 %P e91 %T Mapping a Decade of Physical Activity Interventions for Primary Prevention: A Protocol for a Scoping Review of Reviews %A Goertzen,Leah %A Halas,Gayle %A Rothney,Janet %A Schultz,Annette SH %A Wener,Pamela %A Enns,Jennifer E %A Katz,Alan %+ Manitoba Centre for Health Policy, Department of Community Health Sciences, College of Medicine, Faculty of Health Sciences, University of Manitoba, 408-727 McDermot Ave, 0000-0001-8280-7024, Winnipeg, MB, R3E 3P5, Canada, 1 204 789 3442, alan_katz@cpe.umanitoba.ca %K physical activity %K primary prevention %K protocol %K scoping review %D 2015 %7 27.07.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Physical activity is a key behavioral component for the primary prevention of noncommunicable disease. The uptake of physical activity is influenced by individual and broader factors including social, economic, and environmental conditions. Objective: The purpose of this paper is to describe a protocol for a scoping review of reviews (SRR) that aims to map a decade of research focused on physical activity interventions within the domain of primary prevention. Methods: The 5 stages of our SRRs design were adapted from a seminal scoping review methodology. Our search strategy was developed for the following databases: SPORTDiscus, PubMed, Scopus, the Cochrane Library, the Cumulative Index to Nursing and Allied Health Literature, PsycINFO, and Educational Resources Information Centre. Two reviewers (LG and AK) independently screened eligible studies and compared results to determine the final study selection. One reviewer will conduct the data extraction (LG); a second reviewer (AK) will assess the results to ensure comprehensiveness and accuracy of the scoping review synthesis. Results: The SRRs will provide a broad overview of the physical activity research literature specific to primary prevention, and will describe key features of physical activity interventions. Potential gaps in the physical activity action areas will be identified, and thus, the results will inform future research directions. Conclusions: This paper describes an innovative approach for comprehensively mapping an important topic’s research trends in the last decade. %M 26215502 %R 10.2196/resprot.4240 %U http://www.researchprotocols.org/2015/3/e91/ %U https://doi.org/10.2196/resprot.4240 %U http://www.ncbi.nlm.nih.gov/pubmed/26215502 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 7 %P e184 %T It's LiFe! Mobile and Web-Based Monitoring and Feedback Tool Embedded in Primary Care Increases Physical Activity: A Cluster Randomized Controlled Trial %A van der Weegen,Sanne %A Verwey,Renée %A Spreeuwenberg,Marieke %A Tange,Huibert %A van der Weijden,Trudy %A de Witte,Luc %+ CAPHRI School for Public Health and Primary Care, Department Health Services Research, Maastricht University, PO Box 616, Maastricht, 6200 MD, Netherlands, 31 642756346, s.vanderweegen@vilans.nl %K motor activity %K behavior change %K self-management support %K primary care nursing %K remote sensing technology %K COPD %K type 2 diabetes %D 2015 %7 24.07.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Physical inactivity is a major public health problem. The It’s LiFe! monitoring and feedback tool embedded in the Self-Management Support Program (SSP) is an attempt to stimulate physical activity in people with chronic obstructive pulmonary disease or type 2 diabetes treated in primary care. Objective: Our aim was to evaluate whether the SSP combined with the use of the monitoring and feedback tool leads to more physical activity compared to usual care and to evaluate the additional effect of using this tool on top of the SSP. Methods: This was a three-armed cluster randomised controlled trial. Twenty four family practices were randomly assigned to one of three groups in which participants received the tool + SSP (group 1), the SSP (group 2), or care as usual (group 3). The primary outcome measure was minutes of physical activity per day. The secondary outcomes were general and exercise self-efficacy and quality of life. Outcomes were measured at baseline after the intervention (4-6 months), and 3 months thereafter. Results: The group that received the entire intervention (tool + SSP) showed more physical activity directly after the intervention than Group 3 (mean difference 11.73, 95% CI 6.21-17.25; P<.001), and Group 2 (mean difference 7.86, 95% CI 2.18-13.54; P=.003). Three months after the intervention, this effect was still present and significant (compared to Group 3: mean difference 10.59, 95% CI 4.94-16.25; P<.001; compared to Group 2: mean difference 9.41, 95% CI 3.70-15.11; P<.001). There was no significant difference in effect between Groups 2 and 3 on both time points. There was no interaction effect for disease type. Conclusions: The combination of counseling with the tool proved an effective way to stimulate physical activity. Counseling without the tool was not effective. Future research about the cost-effectiveness and application under more tailored conditions and in other target groups is recommended. Trial Registration: ClinicalTrials.gov: NCT01867970, https://clinicaltrials.gov/ct2/show/NCT01867970 (archived by WebCite at http://www.webcitation.org/6a2qR5BSr). %M 26209025 %R 10.2196/jmir.4579 %U http://www.jmir.org/2015/7/e184/ %U https://doi.org/10.2196/jmir.4579 %U http://www.ncbi.nlm.nih.gov/pubmed/26209025 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 7 %P e185 %T Medium-Term Effectiveness of a Comprehensive Internet-Based and Patient-Specific Telerehabilitation Program With Text Messaging Support for Cardiac Patients: Randomized Controlled Trial %A Frederix,Ines %A Hansen,Dominique %A Coninx,Karin %A Vandervoort,Pieter %A Vandijck,Dominique %A Hens,Niel %A Van Craenenbroeck,Emeline %A Van Driessche,Niels %A Dendale,Paul %+ Mobile Health Institute, Faculty of Medicine & Life Sciences, Hasselt University, Building D, Agoralaan, Diepenbeek, 3590, Belgium, 32 16583382, ines.frederix@gmail.com %K telemedicine %K eHealth %K effectiveness %K Internet %D 2015 %7 23.07.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Cardiac telerehabilitation has been introduced as an adjunct or alternative to conventional center-based cardiac rehabilitation to increase its long-term effectiveness. However, before large-scale implementation and reimbursement in current health care systems is possible, well-designed studies on the effectiveness of this new additional treatment strategy are needed. Objective: The aim of this trial was to assess the medium-term effectiveness of an Internet-based, comprehensive, and patient-tailored telerehabilitation program with short message service (SMS) texting support for cardiac patients. Methods: This multicenter randomized controlled trial consisted of 140 cardiac rehabilitation patients randomized (1:1) to a 24-week telerehabilitation program in combination with conventional cardiac rehabilitation (intervention group; n=70) or to conventional cardiac rehabilitation alone (control group; n=70). In the telerehabilitation program, initiated 6 weeks after the start of ambulatory rehabilitation, patients were stimulated to increase physical activity levels. Based on registered activity data, they received semiautomatic telecoaching via email and SMS text message encouraging them to gradually achieve predefined exercise training goals. Patient-specific dietary and/or smoking cessation advice was also provided as part of the telecoaching. The primary endpoint was peak aerobic capacity (VO2 peak). Secondary endpoints included accelerometer-recorded daily step counts, self-assessed physical activities by International Physical Activity Questionnaire (IPAQ), and health-related quality of life (HRQL) assessed by the HeartQol questionnaire at baseline and at 6 and 24 weeks. Results: Mean VO2 peak increased significantly in intervention group patients (n=69) from baseline (mean 22.46, SD 0.78 mL/[min*kg]) to 24 weeks (mean 24.46, SD 1.00 mL/[min*kg], P<.01) versus control group patients (n=70), who did not change significantly (baseline: mean 22.72, SD 0.74 mL/[min*kg]; 24 weeks: mean 22.15, SD 0.77 mL/[min*kg], P=.09). Between-group analysis of aerobic capacity confirmed a significant difference between the intervention group and control group in favor of the intervention group (P<.001). At 24 weeks, self-reported physical activity improved more in the intervention group compared to the control group (P=.01) as did the global HRQL score (P=.01). Conclusions: This study showed that an additional 6-month patient-specific, comprehensive telerehabilitation program can lead to a bigger improvement in both physical fitness (VO2 peak) and associated HRQL compared to center-based cardiac rehabilitation alone. These results are supportive in view of possible future implementation in standard cardiac care. %M 26206311 %R 10.2196/jmir.4799 %U http://www.jmir.org/2015/7/e185/ %U https://doi.org/10.2196/jmir.4799 %U http://www.ncbi.nlm.nih.gov/pubmed/26206311 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 7 %P e183 %T Online Recruitment Methods for Web-Based and Mobile Health Studies: A Review of the Literature %A Lane,Taylor S %A Armin,Julie %A Gordon,Judith S %+ University of Arizona, Department of Family and Community Medicine, 1450 N Cherry Ave, Tucson, AZ, 85719, United States, 1 520 626 6452, taylorlane@email.arizona.edu %K mHealth %K Internet health %K online recruitment %K apps %K social media %K review %D 2015 %7 22.07.2015 %9 Review %J J Med Internet Res %G English %X Background: Internet and mobile health (mHealth) apps hold promise for expanding the reach of evidence-based health interventions. Research in this area is rapidly expanding. However, these studies may experience problems with recruitment and retention. Web-based and mHealth studies are in need of a wide-reaching and low-cost method of recruitment that will also effectively retain participants for the duration of the study. Online recruitment may be a low-cost and wide-reaching tool in comparison to traditional recruitment methods, although empirical evidence is limited. Objective: This study aims to review the literature on online recruitment for, and retention in, mHealth studies. Methods: We conducted a review of the literature of studies examining online recruitment methods as a viable means of obtaining mHealth research participants. The data sources used were PubMed, CINAHL, EbscoHost, PyscINFO, and MEDLINE. Studies reporting at least one method of online recruitment were included. A narrative approach enabled the authors to discuss the variability in recruitment results, as well as in recruitment duration and study design. Results: From 550 initial publications, 12 studies were included in this review. The studies reported multiple uses and outcomes for online recruitment methods. Web-based recruitment was the only type of recruitment used in 67% (8/12) of the studies. Online recruitment was used for studies with a variety of health domains: smoking cessation (58%; 7/12) and mental health (17%; 2/12) being the most common. Recruitment duration lasted under a year in 67% (8/12) of the studies, with an average of 5 months spent on recruiting. In those studies that spent over a year (33%; 4/12), an average of 17 months was spent on recruiting. A little less than half (42%; 5/12) of the studies found Facebook ads or newsfeed posts to be an effective method of recruitment, a quarter (25%; 3/12) of the studies found Google ads to be the most effective way to reach participants, and one study showed better outcomes with traditional (eg in-person) methods of recruitment. Only one study recorded retention rates in their results, and half (50%; 6/12) of the studies recorded survey completion rates. Conclusions: Although online methods of recruitment may be promising in experimental research, more empirical evidence is needed to make specific recommendations. Several barriers to using online recruitment were identified, including participant retention. These unique challenges of virtual interventions can affect the generalizability and validity of findings from Web-based and mHealth studies. There is a need for additional research to evaluate the effectiveness of online recruitment methods and participant retention in experimental mHealth studies. %M 26202991 %R 10.2196/jmir.4359 %U http://www.jmir.org/2015/7/e183/ %U https://doi.org/10.2196/jmir.4359 %U http://www.ncbi.nlm.nih.gov/pubmed/26202991 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 7 %P e181 %T Evaluation of Internet-Based Interventions on Waist Circumference Reduction: A Meta-Analysis %A Seo,Dong-Chul %A Niu,Jingjing %+ College of Health Sciences, Department of Health Education and Management, Ewha Womans University, Human Ecology Building 204, 52, Ewhayeodae-gil, Seodaemun-gu, Seoul, 120-750, Republic Of Korea, 82 2 3277 2580, dseo@ewha.ac.kr %K waist circumference %K obesity %K adiposity %K Internet %K intervention studies %D 2015 %7 21.07.2015 %9 Review %J J Med Internet Res %G English %X Background: Internet-based interventions are more cost-effective than conventional interventions and can provide immediate, easy-to-access, and individually tailored support for behavior change. Waist circumference is a strong predictor of an increased risk for a host of diseases, such as hypertension, diabetes, and dyslipidemia, independent of body mass index. To date, no study has examined the effect of Internet-based lifestyle interventions on waist circumference change. Objective: This study aimed to systematically review the effect of Internet-based interventions on waist circumference change among adults. Methods: This meta-analysis reviewed randomized controlled trials (N=31 trials and 8442 participants) that used the Internet as a main intervention approach and reported changes in waist circumference. Results: Internet-based interventions showed a significant reduction in waist circumference (mean change –2.99 cm, 95% CI −3.68 to −2.30, I2=93.3%) and significantly better effects on waist circumference loss (mean loss 2.38 cm, 95% CI 1.61-3.25, I2=97.2%) than minimal interventions such as information-only groups. Meta-regression results showed that baseline waist circumference, gender, and the presence of social support in the intervention were significantly associated with waist circumference reduction. Conclusions: Internet-based interventions have a significant and promising effect on waist circumference change. Incorporating social support into an Internet-based intervention appears to be useful in reducing waist circumference. Considerable heterogeneity exists among the effects of Internet-based interventions. The design of an intervention may have a significant impact on the effectiveness of the intervention. %M 26199208 %R 10.2196/jmir.3921 %U http://www.jmir.org/2015/7/e181/ %U https://doi.org/10.2196/jmir.3921 %U http://www.ncbi.nlm.nih.gov/pubmed/26199208 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 3 %P e88 %T Development of Motivate4Change Using the Intervention Mapping Protocol: An Interactive Technology Physical Activity and Medication Adherence Promotion Program for Hospitalized Heart Failure Patients %A Oosterom-Calo,Rony %A te Velde,Saskia J %A Stut,Wim %A Brug,Johannes %+ Philips Research, 345 Scarborough Road, Briarcliff Manor, NY, , United States, 1 480 404 0717, rony.calo@philips.com %K heart failure %K self-care %K self-management %K interactive technology %K medication adherence %K physical activity %K computer tailoring %K intervention mapping %K hospital %D 2015 %7 20.07.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: It is important that heart failure (HF) patients adhere to their medication regimen and engage in physical activity. Evidence shows that adherence to these HF self-management behaviors can be improved with appropriate interventions. Objective: To further promote medication adherence and physical activity among HF patients, we developed an intervention for hospitalized HF patients. Methods: The intervention mapping protocol was applied in the development of the intervention. This entailed performing a needs assessment, defining change objectives, selecting determinants and strategies, and developing the materials. Results: The resulting intervention, Motivate4Change, makes use of interactive technology and provides HF patients with personalized feedback and advice. Specific change objectives were defined. The relevant behavioral determinants for the physical activity program were practical knowledge on physical activity performance and self-efficacy for, and perceived benefits of, physical activity. For medication-taking, the selected determinants were practical knowledge on medication-taking, perceived barriers to medication-taking, beliefs about the necessity and harm regarding the medication prescribed, and beliefs about overprescribing and harm of medication in general. The change objectives and behavior change determinants were translated in feedback and advice strategies in an interactive technology program that included tailored feedback and advice, and role models in videos in which the behaviors and overcoming barriers were demonstrated. Relevant stakeholders were involved in the interventions development process. The intervention was pretested among HF patients and adjustments were made accordingly. Conclusions: The interactive technology physical activity and medication adherence promotion program for hospitalized HF patients was systematically developed using the intervention mapping protocol and was based on the available theory and evidence regarding HF self-management behavior change. The intervention’s efficacy is yet to be determined in evaluation research. %M 26195072 %R 10.2196/resprot.4282 %U http://www.researchprotocols.org/2015/3/e88/ %U https://doi.org/10.2196/resprot.4282 %U http://www.ncbi.nlm.nih.gov/pubmed/26195072 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 7 %P e180 %T The Mobile Insulin Titration Intervention (MITI) for Insulin Adjustment in an Urban, Low-Income Population: Randomized Controlled Trial %A Levy,Natalie %A Moynihan,Victoria %A Nilo,Annielyn %A Singer,Karyn %A Bernik,Lidia S %A Etiebet,Mary-Ann %A Fang,Yixin %A Cho,James %A Natarajan,Sundar %+ Division of General Internal Medicine and Clinical Innovation, Department of Medicine, New York University School of Medicine, Bellevue CD building, 630, 462 First Ave, New York, NY, 10016, United States, 1 646 501 0691, Victoria.Ramsay@nyumc.org %K patient-centered care %K health care disparities %K telemedicine %K remote consultation %K cell phones %K insulin, long-acting %K text messaging %D 2015 %7 17.07.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Diabetes patients are usually started on a low dose of insulin and their dose is adjusted or “titrated” according to their blood glucose levels. Insulin titration administered through face-to-face visits with a clinician can be time consuming and logistically burdensome for patients, especially those of low socioeconomic status (SES). Given the wide use of mobile phones among this population, there is the potential to use short message service (SMS) text messaging and phone calls to perform insulin titration remotely. Objective: The goals of this pilot study were to (1) evaluate if our Mobile Insulin Titration Intervention (MITI) intervention using text messaging and phone calls was effective in helping patients reach their optimal insulin glargine dose within 12 weeks, (2) assess the feasibility of the intervention within our clinic setting and patient population, (3) collect data on the cost savings associated with the intervention, and (4) measure patient satisfaction with the intervention. Methods: This was a pilot study evaluating an intervention for patients requiring insulin glargine titration in the outpatient medical clinic of Bellevue Hospital Center in New York City. Patients in the intervention arm received weekday SMS text messages from a health management platform requesting their fasting blood glucose values. The clinic’s diabetes nurse educator monitored the texted responses on the platform website each weekday for alarm values. Once a week, the nurse reviewed the glucose values, consulted the MITI titration algorithm, and called patients to adjust their insulin dose. Patients in the usual care arm continued to receive their standard clinic care for insulin titration. The primary outcome was whether a patient reached his/her optimal insulin glargine dose within 12 weeks. Results: A total of 61 patients consented and were randomized into the study. A significantly greater proportion of patients in the intervention arm reached their optimal insulin glargine dose than patients in the usual care arm (88%, 29/33 vs 37%, 10/27; P<.001). Patients responded to 84.3% (420/498) of the SMS text messages requesting their blood glucose values. The nurse reached patients within 2 attempts or by voicemail 91% of the time (90/99 assigned calls). When patients traveled to the clinic, they spent a median of 45 minutes (IQR 30-60) on travel and 39 minutes (IQR 30-64) waiting prior to appointments. A total of 61% (37/61) of patients had appointment copays. After participating in the study, patients in the intervention arm reported higher treatment satisfaction than those in the usual care arm. Conclusions: MITI is an effective way to help low-SES patients reach their optimal insulin glargine dose using basic SMS text messaging and phone calls. The intervention was feasible and patients were highly satisfied with their treatment. The intervention was cost saving in terms of time for patients, who were able to have their insulin titrated without multiple clinic appointments. Similar interventions should be explored to improve care for low-SES patients managing chronic disease. Trial Registration: Clinicaltrials.gov NCT01879579; https://clinicaltrials.gov/ct2/show/NCT01879579 (Archived by WebCite at http://www.webcitation.org/6YZik33L3). %M 26187303 %R 10.2196/jmir.4716 %U http://www.jmir.org/2015/7/e180/ %U https://doi.org/10.2196/jmir.4716 %U http://www.ncbi.nlm.nih.gov/pubmed/26187303 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 3 %P e87 %T Mobile App-Delivered Cognitive Behavioral Therapy for Insomnia: Feasibility and Initial Efficacy Among Veterans With Cannabis Use Disorders %A Babson,Kimberly A %A Ramo,Danielle E %A Baldini,Lisa %A Vandrey,Ryan %A Bonn-Miller,Marcel O %+ National Center for PTSD, VA Palo Alto Health Care System, 795 Willow Road, Menlo Park, CA, 94025, United States, 1 650 493 5000, kimberly.babson@gmail.com %K cannabis %K marijuana %K sleep %K CBT-I %K intervention %D 2015 %7 17.07.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Cannabis is the most frequently used illicit substance in the United States resulting in high rates of cannabis use disorders. Current treatments for cannabis use are often met with high rates of lapse/relapse, tied to (1) behavioral health factors that impact cannabis use such as poor sleep, and (2) access, stigma, supply, and cost of receiving a substance use intervention. Objective: This pilot study examined the feasibility, usability, and changes in cannabis use and sleep difficulties following mobile phone–delivered Cognitive Behavioral Therapy for Insomnia (CBT-I) in the context of a cannabis cessation attempt. Methods: Four male veterans with DSM-5 cannabis use disorder and sleep problems were randomized to receive a 2-week intervention: CBT-I Coach mobile app (n=2) or a placebo control (mood-tracking app) (n=2). Cannabis and sleep measures were assessed pre- and post-treatment. Participants also reported use and helpfulness of each app. Changes in sleep and cannabis use were evaluated for each participant individually. Results: Both participants receiving CBT-I used the app daily over 2 weeks and found the app user-friendly, helpful, and would use it in the future. In addition, they reported decreased cannabis use and improved sleep efficiency; one also reported increased sleep quality. In contrast, one participant in the control group dropped out of the study, and the other used the app minimally and reported increased sleep quality but also increased cannabis use. The mood app was rated as not helpful, and there was low likelihood of future participation. Conclusions: This pilot study examined the feasibility and initial patient acceptance of mobile phone delivery of CBT-I for cannabis dependence. Positive ratings of the app and preliminary reports of reductions in cannabis use and improvements in sleep are both encouraging and support additional evaluation of this intervention. %M 26187404 %R 10.2196/resprot.3852 %U http://www.researchprotocols.org/2015/3/e87/ %U https://doi.org/10.2196/resprot.3852 %U http://www.ncbi.nlm.nih.gov/pubmed/26187404 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 7 %P e177 %T Effect of a Web-Based Behavior Change Program on Weight Loss and Cardiovascular Risk Factors in Overweight and Obese Adults at High Risk of Developing Cardiovascular Disease: Randomized Controlled Trial %A Watson,Sinead %A Woodside,Jayne V %A Ware,Lisa J %A Hunter,Steven J %A McGrath,Alanna %A Cardwell,Christopher R %A Appleton,Katherine M %A Young,Ian S %A McKinley,Michelle C %+ Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen’s University Belfast, Institute of Clinical Science Block B, Grosvenor Road, Belfast, BT12 6BJ, United Kingdom, 44 (0)28 9063 2685, m.mckinley@qub.ac.uk %K Internet %K randomized controlled trial %K health behavior %K weight loss %K overweight %K obesity %D 2015 %7 16.07.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based programs are a potential medium for supporting weight loss because of their accessibility and wide reach. Research is warranted to determine the shorter- and longer-term effects of these programs in relation to weight loss and other health outcomes. Objective: The aim was to evaluate the effects of a Web-based component of a weight loss service (Imperative Health) in an overweight/obese population at risk of cardiovascular disease (CVD) using a randomized controlled design and a true control group. Methods: A total of 65 overweight/obese adults at high risk of CVD were randomly allocated to 1 of 2 groups. Group 1 (n=32) was provided with the Web-based program, which supported positive dietary and physical activity changes and assisted in managing weight. Group 2 continued with their usual self-care (n=33). Assessments were conducted face-to-face. The primary outcome was between-group change in weight at 3 months. Secondary outcomes included between-group change in anthropometric measurements, blood pressure, lipid measurements, physical activity, and energy intake at 3, 6, and 12 months. Interviews were conducted to explore participants’ views of the Web-based program. Results: Retention rates for the intervention and control groups at 3 months were 78% (25/32) vs 97% (32/33), at 6 months were 66% (21/32) vs 94% (31/33), and at 12 months were 53% (17/32) vs 88% (29/33). Intention-to-treat analysis, using baseline observation carried forward imputation method, revealed that the intervention group lost more weight relative to the control group at 3 months (mean –3.41, 95% CI –4.70 to –2.13 kg vs mean –0.52, 95% CI –1.55 to 0.52 kg, P<.001), at 6 months (mean –3.47, 95% CI –4.95 to –1.98 kg vs mean –0.81, 95% CI –2.23 to 0.61 kg, P=.02), but not at 12 months (mean –2.38, 95% CI –3.48 to –0.97 kg vs mean –1.80, 95% CI –3.15 to –0.44 kg, P=.77). More intervention group participants lost ≥5% of their baseline body weight at 3 months (34%, 11/32 vs 3%, 1/33, P<.001) and 6 months (41%, 13/32 vs 18%, 6/33, P=.047), but not at 12 months (22%, 7/32 vs 21%, 7/33, P=.95) versus control group. The intervention group showed improvements in total cholesterol, triglycerides, and adopted more positive dietary and physical activity behaviors for up to 3 months verus control; however, these improvements were not sustained. Conclusions: Although the intervention group had high attrition levels, this study provides evidence that this Web-based program can be used to initiate clinically relevant weight loss and lower CVD risk up to 3-6 months based on the proportion of intervention group participants losing ≥5% of their body weight versus control group. It also highlights a need for augmenting Web-based programs with further interventions, such as in-person support to enhance engagement and maintain these changes. Trial Registration: ClinicalTrials.gov NCT01472276; http://clinicaltrials.gov/ct2/show/study/NCT01472276 (Archived by Webcite at http://www.webcitation.org/6Z9lfj8nD). %M 26183659 %R 10.2196/jmir.3828 %U http://www.jmir.org/2015/7/e177/ %U https://doi.org/10.2196/jmir.3828 %U http://www.ncbi.nlm.nih.gov/pubmed/26183659 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 7 %P e179 %T Impact of Baseline Assessment Modality on Enrollment and Retention in a Facebook Smoking Cessation Study %A Villanti,Andrea C %A Jacobs,Megan A %A Zawistowski,Grace %A Brookover,Jody %A Stanton,Cassandra A %A Graham,Amanda L %+ The Schroeder Institute for Tobacco Research and Policy Studies, Legacy, 1724 Massachusetts Ave NW, Washington, DC, 20036, United States, 1 202 454 5751, avillanti@legacyforhealth.org %K research subject recruitment %K smoking cessation %K Internet %K social networking %K adult %D 2015 %7 16.07.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Few studies have addressed enrollment and retention methods in online smoking cessation interventions. Fully automated Web-based trials can yield large numbers of participants rapidly but suffer from high rates of attrition. Personal contact with participants can increase recruitment of smokers into cessation trials and improve participant retention. Objective: To compare the impact of Web-based (WEB) and phone (PH) baseline assessments on enrollment and retention metrics in the context of a Facebook smoking cessation study. Methods: Participants were recruited via Facebook and Google ads which were randomly displayed to adult smokers in the United States over 27 days from August to September 2013. On each platform, two identical ads were randomly displayed to users who fit the advertising parameters. Clicking on one of the ads resulted in randomization to WEB, and clicking on the other ad resulted in randomization to PH. Following online eligibility screening and informed consent, participants in the WEB arm completed the baseline survey online whereas PH participants completed the baseline survey by phone with a research assistant. All participants were contacted at 30 days to complete a follow-up survey that assessed use of the cessation intervention and smoking outcomes. Participants were paid $15 for follow-up survey completion. Results: A total of 4445 people clicked on the WEB ad and 4001 clicked on the PH ad: 12.04% (n=535) of WEB participants and 8.30% (n=332) of PH participants accepted the online study invitation (P<.001). Among the 726 participants who completed online eligibility screening, an equivalent proportion in both arms was eligible and an equivalent proportion of the eligible participants in both arms provided informed consent. There was significant drop-off between consent and completion of the baseline survey in the PH arm, resulting in enrollment rates of 32.7% (35/107) for the PH arm and 67.9% (114/168) for the WEB arm (P<.001). The overall enrollment rate among everyone who clicked on a study ad was 2%. There were no between group differences in the proportion that installed the Facebook app (66/114, 57.9% WEB vs 17/35, 49% PH) or that completed the 30-day follow-up survey (49/114, 43.0% WEB vs 16/35, 46% PH). A total of $6074 was spent on ads, generating 3,834,289 impressions and resulting in 8446 clicks (average cost $0.72 per click). Per participant enrollment costs for advertising alone were $27 WEB and $87 PH. Conclusions: A more intensive phone baseline assessment protocol yielded a lower rate of enrollment, equivalent follow-up rates, and higher enrollment costs compared to a Web-based assessment protocol. Future research should focus on honing mixed-mode assessment protocols to further optimize enrollment and retention. %M 26183789 %R 10.2196/jmir.4341 %U http://www.jmir.org/2015/7/e179/ %U https://doi.org/10.2196/jmir.4341 %U http://www.ncbi.nlm.nih.gov/pubmed/26183789 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 7 %P e176 %T Engagement and Nonusage Attrition With a Free Physical Activity Promotion Program: The Case of 10,000 Steps Australia %A Guertler,Diana %A Vandelanotte,Corneel %A Kirwan,Morwenna %A Duncan,Mitch J %+ Institute of Social Medicine and Prevention, University Medicine, Walther-Rathenau-Strasse 48, Greifswald, 17475, Germany, 49 3834867716, diana.guertler@uni-greifswald.de %K physical activity %K Internet %K engagement %K smartphone %D 2015 %7 15.07.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Data from controlled trials indicate that Web-based interventions generally suffer from low engagement and high attrition. This is important because the level of exposure to intervention content is linked to intervention effectiveness. However, data from real-life Web-based behavior change interventions are scarce, especially when looking at physical activity promotion. Objective: The aims of this study were to (1) examine the engagement with the freely available physical activity promotion program 10,000 Steps, (2) examine how the use of a smartphone app may be helpful in increasing engagement with the intervention and in decreasing nonusage attrition, and (3) identify sociodemographic- and engagement-related determinants of nonusage attrition. Methods: Users (N=16,948) were grouped based on which platform (website, app) they logged their physical activity: Web only, app only, or Web and app. Groups were compared on sociodemographics and engagement parameters (duration of usage, number of individual and workplace challenges started, and number of physical activity log days) using ANOVA and chi-square tests. For a subsample of users that had been members for at least 3 months (n=11,651), Kaplan-Meier survival curves were estimated to plot attrition over the first 3 months after registration. A Cox regression model was used to determine predictors of nonusage attrition. Results: In the overall sample, user groups differed significantly in all sociodemographics and engagement parameters. Engagement with the program was highest for Web-and-app users. In the subsample, 50.00% (5826/11,651) of users stopped logging physical activity through the program after 30 days. Cox regression showed that user group predicted nonusage attrition: Web-and-app users (hazard ratio=0.86, 95% CI 0.81-0.93, P<.001) and app-only users (hazard ratio=0.63, 95% CI 0.58-0.68, P<.001) showed a reduced attrition risk compared to Web-only users. Further, having a higher number of individual challenges (hazard ratio=0.62, 95% CI 0.59-0.66, P<.001), workplace challenges (hazard ratio=0.94, 95% CI 0.90-0.97, P<.001), physical activity logging days (hazard ratio=0.921, 95% CI 0.919-0.922, P<.001), and steps logged per day (hazard ratio=0.99999, 95% CI 0.99998-0.99999, P<.001) were associated with reduced nonusage attrition risk as well as older age (hazard ratio=0.992, 95% CI 0.991-0.994, P<.001), being male (hazard ratio=0.85, 95% CI 0.82-0.89, P<.001), and being non-Australian (hazard ratio=0.87, 95% CI 0.82-0.91, P<.001). Conclusions: Compared to other freely accessible Web-based health behavior interventions, the 10,000 Steps program showed high engagement. The use of an app alone or in addition to the website can enhance program engagement and reduce risk of attrition. Better understanding of participant reasons for reducing engagement can assist in clarifying how to best address this issue to maximize behavior change. %M 26180040 %R 10.2196/jmir.4339 %U http://www.jmir.org/2015/7/e176/ %U https://doi.org/10.2196/jmir.4339 %U http://www.ncbi.nlm.nih.gov/pubmed/26180040 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 7 %P e174 %T A Web-Based, Social Networking Physical Activity Intervention for Insufficiently Active Adults Delivered via Facebook App: Randomized Controlled Trial %A Maher,Carol %A Ferguson,Monika %A Vandelanotte,Corneel %A Plotnikoff,Ron %A De Bourdeaudhuij,Ilse %A Thomas,Samantha %A Nelson-Field,Karen %A Olds,Tim %+ Alliance for Research in Exercise, Nutrition and Activity, University of South Australia, GPO Box 2471, Adelaide, 5001, Australia, 61 08 830 ext 22315, carol.maher@unisa.edu.au %K social network %K behavior change %K intervention %K Internet %K physical activity %D 2015 %7 13.07.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Online social networks offer considerable potential for delivery of socially influential health behavior change interventions. Objective: To determine the efficacy, engagement, and feasibility of an online social networking physical activity intervention with pedometers delivered via Facebook app. Methods: A total of 110 adults with a mean age of 35.6 years (SD 12.4) were recruited online in teams of 3 to 8 friends. Teams were randomly allocated to receive access to a 50-day online social networking physical activity intervention which included self-monitoring, social elements, and pedometers (“Active Team” Facebook app; n=51 individuals, 12 teams) or a wait-listed control condition (n=59 individuals, 13 teams). Assessments were undertaken online at baseline, 8 weeks, and 20 weeks. The primary outcome measure was self-reported weekly moderate-to-vigorous physical activity (MVPA). Secondary outcomes were weekly walking, vigorous physical activity time, moderate physical activity time, overall quality of life, and mental health quality of life. Analyses were undertaken using random-effects mixed modeling, accounting for potential clustering at the team level. Usage statistics were reported descriptively to determine engagement and feasibility. Results: At the 8-week follow-up, the intervention participants had significantly increased their total weekly MVPA by 135 minutes relative to the control group (P=.03), due primarily to increases in walking time (155 min/week increase relative to controls, P<.001). However, statistical differences between groups for total weekly MVPA and walking time were lost at the 20-week follow-up. There were no significant changes in vigorous physical activity, nor overall quality of life or mental health quality of life at either time point. High levels of engagement with the intervention, and particularly the self-monitoring features, were observed. Conclusions: An online, social networking physical activity intervention with pedometers can produce sizable short-term physical activity changes. Future work is needed to determine how to maintain behavior change in the longer term, how to reach at-need populations, and how to disseminate such interventions on a mass scale. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614000488606; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366239 (Archived by WebCite at http://www.webcitation.org/6ZVtu6TMz). %M 26169067 %R 10.2196/jmir.4086 %U http://www.jmir.org/2015/7/e174/ %U https://doi.org/10.2196/jmir.4086 %U http://www.ncbi.nlm.nih.gov/pubmed/26169067 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 7 %P e172 %T How to Increase Reach and Adherence of Web-Based Interventions: A Design Research Viewpoint %A Ludden,Geke DS %A van Rompay,Thomas JL %A Kelders,Saskia M %A van Gemert-Pijnen,Julia EWC %+ Department of Design, Faculty of Engineering Technology, University of Twente, Horstring W254, de Horst, Enschede, 7522 LW, Netherlands, 31 534892920, g.d.s.ludden@utwente.nl %K Web-based interventions %K adherence %K design for well-being %K metaphors %K personalization %K ambient information %D 2015 %7 10.07.2015 %9 Viewpoint %J J Med Internet Res %G English %X Nowadays, technology is increasingly used to increase people’s well-being. For example, many mobile and Web-based apps have been developed that can support people to become mentally fit or to manage their daily diet. However, analyses of current Web-based interventions show that many systems are only used by a specific group of users (eg, women, highly educated), and that even they often do not persist and drop out as the intervention unfolds. In this paper, we assess the impact of design features of Web-based interventions on reach and adherence and conclude that the power that design can have has not been used to its full potential. We propose looking at design research as a source of inspiration for new (to the field) design approaches. The paper goes on to specify and discuss three of these approaches: personalization, ambient information, and use of metaphors. Central to our viewpoint is the role of positive affect triggered by well-designed persuasive features to boost adherence and well-being. Finally, we discuss the future of persuasive eHealth interventions and suggest avenues for follow-up research. %M 26163456 %R 10.2196/jmir.4201 %U http://www.jmir.org/2015/7/e172/ %U https://doi.org/10.2196/jmir.4201 %U http://www.ncbi.nlm.nih.gov/pubmed/26163456 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 7 %P e170 %T Online Alcohol Assessment and Feedback for Hazardous and Harmful Drinkers: Findings From the AMADEUS-2 Randomized Controlled Trial of Routine Practice in Swedish Universities %A Bendtsen,Preben %A Bendtsen,Marcus %A Karlsson,Nadine %A White,Ian R %A McCambridge,Jim %+ Medical Faculty, Department of Medical Specialist and Department of Medicine and Health Sciences, Linköping University, Motala, Campus US, Linköping, Se-581 83, Sweden, 46 702324615, preben.bendtsen@liu.se %K alcohol drinking %K behavior therapy %K students %K Internet %K electronic mail, feedback %D 2015 %7 09.07.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Previous research on the effectiveness of online alcohol interventions for college students has shown mixed results. Small benefits have been found in some studies and because online interventions are inexpensive and possible to implement on a large scale, there is a need for further study. Objective: This study evaluated the effectiveness of national provision of a brief online alcohol intervention for students in Sweden. Methods: Risky drinkers at 9 colleges and universities in Sweden were invited by mail and identified using a single screening question. These students (N=1605) gave consent and were randomized into a 2-arm parallel group randomized controlled trial consisting of immediate or delayed access to a fully automated online assessment and intervention with personalized feedback. Results: After 2 months, there was no strong evidence of effectiveness with no statistically significant differences in the planned analyses, although there were some indication of possible benefit in sensitivity analyses suggesting an intervention effect of a 10% reduction (95% CI –30% to 10%) in total weekly alcohol consumption. Also, differences in effect sizes between universities were seen with participants from a major university (n=365) reducing their weekly alcohol consumption by 14% (95% CI –23% to –4%). However, lower recruitment than planned and differential attrition in the intervention and control group (49% vs 68%) complicated interpretation of the outcome data. Conclusions: Any effects of current national provision are likely to be small and further research and development work is needed to enhance effectiveness. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 02335307; http://www.isrctn.com/ISRCTN02335307 (Archived by WebCite at http://www.webcitation.org/6ZdPUh0R4). %M 26159179 %R 10.2196/jmir.4020 %U http://www.jmir.org/2015/7/e170/ %U https://doi.org/10.2196/jmir.4020 %U http://www.ncbi.nlm.nih.gov/pubmed/26159179 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 7 %P e167 %T The Web-Based Osteoarthritis Management Resource My Joint Pain Improves Quality of Care: A Quasi-Experimental Study %A Umapathy,Hema %A Bennell,Kim %A Dickson,Chris %A Dobson,Fiona %A Fransen,Marlene %A Jones,Graeme %A Hunter,David J %+ Institute of Bone and Joint Research, The Kolling Institute, Department of Rheumatology, University of Sydney, Clinical administration 7A, Royal North Shore Hospital, Reserve Road, Sydney, 2065, Australia, 61 29463 1896, david.hunter@sydney.edu.au %K quality of health care %K self-care %K osteoarthritis %K eHealth %K Internet %D 2015 %7 07.07.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Despite the availability of evidence-based guidelines for conservative treatment of osteoarthritis (OA), management is often confined to the use of analgesics and waiting for eventual total joint replacement. This suggests a gap in knowledge for persons with OA regarding the many different treatments available to them. Objective: Our objective was to evaluate outcomes after usage of a Web-based resource called My Joint Pain that contains tailored, evidence-based information and tools aimed to improve self-management of OA on self-management and change in knowledge. Methods: A quasi-experimental design was used to evaluate the My Joint Pain website intervention over a 12-month period. The intervention provided participants with general and user-specific information, monthly assessments with validated instruments, and progress-tracking tools. A nationwide convenience sample of 195 participants with self-assessed hip and/or knee OA completed both baseline and 12-month questionnaires (users: n=104; nonusers: n=91). The primary outcome measure was the Health Evaluation Impact Questionnaire (heiQ) to evaluate 8 different domains (health-directed activity, positive and active engagement in life, emotional distress, self-monitoring and insight, constructive attitudes and approaches, skill and technique acquisition, social integration and support, health service navigation) and the secondary outcome measure was the 17-item Osteoarthritis Quality Indicator (OAQI) questionnaire to evaluate the change in appropriateness of care received by participants. Independent t tests were used to compare changes between groups for the heiQ and chi-square tests to identify changes within and between groups from baseline to 12 months for each OAQI item. Results: Baseline demographics between groups were similar for gender (152/195, 77.9% female), age (mean 60, SD 9 years) and body mass index (mean 31.1, SD 6.8 kg/m2). With the exception of health service navigation, mean effect sizes from all other heiQ domains showed a positive trend for My Joint Pain users compared to the nonusers, although the differences between groups did not reach statistical significance. Within-group changes also showed improvements among the users of the My Joint Pain website for self-management (absolute change score=15%, P=.03), lifestyle (absolute change score=16%, P=.02), and physical activity (absolute change score=11%, P=.04), with no significant improvements for the nonusers. Following 12 months of exposure to the website, there were significant improvements for users compared to nonusers in self-management (absolute change score 15% vs 2%, P=.001) and weight reduction (absolute change scores 3% vs –6%, P=.03) measured on the OAQI. Conclusions: The My Joint Pain Web resource does not significantly improve overall heiQ, but does improve other important aspects of quality of care in people with hip and/or knee OA. Further work is required to improve engagement with the website and the quality of information delivered in order to provide a greater impact. %M 26154022 %R 10.2196/jmir.4376 %U http://www.jmir.org/2015/7/e167/ %U https://doi.org/10.2196/jmir.4376 %U http://www.ncbi.nlm.nih.gov/pubmed/26154022 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 7 %P e164 %T Prevalence and Frequency of mHealth and eHealth Use Among US and UK Smokers and Differences by Motivation to Quit %A Borrelli,Belinda %A Bartlett,Yvonne Kiera %A Tooley,Erin %A Armitage,Christopher J %A Wearden,Alison %+ Boston University, Henry M Goldman School of Dental Medicine, 560 Harrison Ave, 3rd floor, Boston, MA, 02118, United States, 1 617 414 1116, belindab@bu.edu %K smoking cessation %K eHealth %K mHealth %K health behavior %K motivation %K text messaging %D 2015 %7 4.7.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Both mHealth and eHealth interventions for smoking cessation are rapidly being developed and tested. There are no data on use of mHealth and eHealth technologies by smokers in general or by smokers who are not motivated to quit smoking. Objective: The aims of our study were to (1) assess technology use (eg, texting, social media, Internet) among smokers in the United States and United Kingdom, (2) examine whether technology use differs between smokers who are motivated to quit and smokers who are not motivated to quit, (3) examine previous use of technology to assist with smoking cessation, and (4) examine future intentions to use technology to assist with smoking cessation. Methods: Participants were 1000 adult smokers (54.90%, 549/1000 female; mean age 43.9, SD 15.5 years; US: n=500, UK: n=500) who were recruited via online representative sampling strategies. Data were collected online and included demographics, smoking history, and frequency and patterns of technology use. Results: Among smokers in general, there was a high prevalence of mobile and smartphone ownership, sending and receiving texts, downloading and using apps, using Facebook, and visiting health-related websites. Smokers who were unmotivated to quit were significantly less likely to own a smartphone or handheld device that connects to the Internet than smokers motivated to quit. There was a significantly lower prevalence of sending text messages among US smokers unmotivated to quit (78.2%, 179/229) versus smokers motivated to quit (95.0%, 229/241), but no significant differences between the UK groups (motivated: 96.4%, 239/248; unmotivated: 94.9%, 223/235). Smokers unmotivated to quit in both countries were significantly less likely to use a handheld device to read email, play games, browse the Web, or visit health-related websites versus smokers motivated to quit. US smokers had a high prevalence of app downloads regardless of motivation to quit, but UK smokers who were motivated to quit had greater prevalence of app downloads than smokers unmotivated to quit. US smokers were significantly more likely to have a Facebook account (87.0%, 435/500) than UK smokers (76.4%, 382/500), but smokers unmotivated to quit in both countries used Facebook less frequently than smokers motivated to quit. Smokers who were unmotivated to quit were less likely to have used eHealth or mHealth platforms to help them quit smoking in the past and less likely to say that they would use them for smoking cessation in the future. Conclusions: Although smokers unmotivated to quit make less use of technology than smokers motivated to quit, there is sufficient prevalence to make it worthwhile to develop eHealth and mHealth interventions to encourage cessation. Short and low-effort communications, such as text messaging, might be better for smokers who are less motivated to quit. Multiple channels may be required to reach unmotivated smokers. %M 26149323 %R 10.2196/jmir.4420 %U http://www.jmir.org/2015/7/e164/ %U https://doi.org/10.2196/jmir.4420 %U http://www.ncbi.nlm.nih.gov/pubmed/26149323 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 3 %P e82 %T Defining the Content of an Online Sexual Health Intervention: The MenSS Website %A Webster,Rosie %A Gerressu,Makeda %A Michie,Susan %A Estcourt,Claudia %A Anderson,Jane %A Ang,Chee Siang %A Murray,Elizabeth %A Rait,Greta %A Stephenson,Judith %A Bailey,Julia V %A , %+ eHealth Unit, Research Department of Primary Care and Population Health, University College London, Royal Free Hospital, Rowland Hill Street, London, NW3 2PF, United Kingdom, 44 207794050031 ext 31429, drrosiewebster@gmail.com %K eHealth %K behavior change %K sexual health %K condom use %K sex education %K heterosexual men %K web-based intervention %D 2015 %7 03.07.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Health promotion and risk reduction are essential components of sexual health care. However, it can be difficult to prioritize these within busy clinical services. Digital interventions may provide a new method for supporting these. Objective: The MenSS (Men’s Safer Sex) website is an interactive digital intervention developed by a multidisciplinary team, which aims to improve condom use in men who have sex with women (MSW). This paper describes the content of this intervention, and the rationale for it. Methods: Content was informed by a literature review regarding men’s barriers to condom use, workshops with experts in sexual health and technology (N=16) and interviews with men in sexual health clinics (N=20). Data from these sources were analyzed thematically, and synthesized using the Behavior Change Wheel framework. Results: The MenSS intervention is a website optimized for delivery via tablet computer within a clinic waiting room setting. Key targets identified were condom use skills, beliefs about pleasure and knowledge about risk. Content was developed using behavior change techniques, and interactive website features provided feedback tailored for individual users. Conclusions: This paper provides a detailed description of an evidence-based interactive digital intervention for sexual health, including how behavior change techniques were translated into practice within the design of the MenSS website. Triangulation between a targeted literature review, expert workshops, and interviews with men ensured that a range of potential influences on condom use were captured. %M 26142304 %R 10.2196/resprot.4316 %U http://www.researchprotocols.org/2015/3/e82/ %U https://doi.org/10.2196/resprot.4316 %U http://www.ncbi.nlm.nih.gov/pubmed/26142304 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 3 %P e81 %T The Space From Heart Disease Intervention for People With Cardiovascular Disease and Distress: A Mixed-Methods Study %A Barley,Elizabeth Alexandra %A Clifton,Abigail %A Lee,Geraldine %A Norman,Ian J %A O'Callaghan,David %A Tierney,Karen %A Richards,Derek %+ Post Graduate Research Department, Florence Nightingale Faculty of Nursing and Midwifery, King's College London, James Clerk Maxwell Building, 57 Waterloo Road, London, SE1 8WA, United Kingdom, 44 2078483707, elizabeth.barley@kcl.ac.uk %K Internet %K depression %K anxiety %K well-being %K cognitive behavioral therapy %K behavioral therapy %K self-management %K cardiovascular disease %K online interventions %D 2015 %7 01.07.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Poor self-management of symptoms and psychological distress leads to worse outcomes and excess health service use in cardiovascular disease (CVD). Online-delivered therapy is effective, but generic interventions lack relevance for people with specific long-term conditions, such as cardiovascular disease. Objective: To develop a comprehensive online CVD-specific intervention to improve both self-management and well-being, and to test acceptability and feasibility. Methods: Informed by the Medical Research Council (MRC) guidance for the development of complex interventions, we adapted an existing evidence-based generic intervention for depression and anxiety for people with CVD. Content was informed by a literature review of existing resources and trial evidence, and the findings of a focus group study. Think-aloud usability testing was conducted to identify improvements to design and content. Acceptability and feasibility were tested in a cross-sectional study. Results: Focus group participants (n=10) agreed that no existing resource met all their needs. Improvements such as "collapse and expand" features were added based on findings that participants’ information needs varied, and specific information, such as detecting heart attacks and when to seek help, was added. Think-aloud testing (n=2) led to changes in font size and design changes around navigation. All participants of the cross-sectional study (10/10, 100%) were able to access and use the intervention. Reported satisfaction was good, although the intervention was perceived to lack relevance for people without comorbid psychological distress. Conclusions: We have developed an evidence-based, theory-informed, user-led online intervention for improving self-management and well-being in CVD. The use of multiple evaluation tests informed improvements to content and usability. Preliminary acceptability and feasibility has been demonstrated. The Space from Heart Disease intervention is now ready to be tested for effectiveness. This work has also identified that people with CVD symptoms and comorbid distress would be the most appropriate sample for a future randomized controlled trial to evaluate its effectiveness. %M 26133739 %R 10.2196/resprot.4280 %U http://www.researchprotocols.org/2015/3/e81/ %U https://doi.org/10.2196/resprot.4280 %U http://www.ncbi.nlm.nih.gov/pubmed/26133739 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 3 %N 2 %P e70 %T Uptake and Acceptability of Information and Communication Technology in a Community-Based Cohort of People Who Inject Drugs: Implications for Mobile Health Interventions %A Genz,Andrew %A Kirk,Gregory %A Piggott,Damani %A Mehta,Shruti H %A Linas,Beth S %A Westergaard,Ryan P %+ Department of Medicine, University of Wisconsin-Madison, 1685 Highland Ave, MFCB 5220, Madison, WI, 53705, United States, 1 6082657927, rpw@medicine.wisc.edu %K substance abuse %K intravenous %K Internet %K cellular phone %K text messaging %K telemedicine %D 2015 %7 25.6.2015 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: Mobile phone and Internet-based technologies are increasingly used to disseminate health information and facilitate delivery of medical care. While these strategies hold promise for reducing barriers to care for medically-underserved populations, their acceptability among marginalized populations such as people who inject drugs is not well-understood. Objective: To understand patterns of mobile phone ownership, Internet use and willingness to receive health information via mobile devices among people who inject drugs. Methods: We surveyed current and former drug injectors participating in a longitudinal cohort study in Baltimore, Maryland, USA. Respondents completed a 12-item, interviewer-administered questionnaire during a regular semi-annual study visit that assessed their use of mobile technology and preferred modalities of receiving health information. Using data from the parent study, we used logistic regression to evaluate associations among participants’ demographic and clinical characteristics and their mobile phone and Internet use. Results: The survey was completed by 845 individuals, who had a median age of 51 years. The sample was 89% African-American, 65% male, and 33% HIV-positive. Participants were generally of low education and income levels. Fewer than half of respondents (40%) indicated they had ever used the Internet. Mobile phones were used by 86% of respondents. Among mobile phone owners, 46% had used their phone for text messaging and 25% had accessed the Internet on their phone. A minority of respondents (42%) indicated they would be interested in receiving health information via phone or Internet. Of those receptive to receiving health information, a mobile phone call was the most favored modality (66%) followed by text messaging (58%) and Internet (51%). Conclusions: Utilization of information and communication technology among this cohort of people who inject drugs was reported at a lower level than what has been estimated for the general U.S. population. Our findings identify a potential barrier to successful implementation of mobile health and Internet-based interventions for people who inject drugs, particularly those who are older and have lower levels of income and educational attainment. As mobile communication technology continues to expand, future studies should re-examine whether mHealth applications become more accessible and accepted by socioeconomically disadvantaged groups. %M 26111915 %R 10.2196/mhealth.3437 %U http://mhealth.jmir.org/2015/2/e70/ %U https://doi.org/10.2196/mhealth.3437 %U http://www.ncbi.nlm.nih.gov/pubmed/26111915 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 6 %P e152 %T Web-Based Cognitive Behavioral Therapy for Female Patients With Eating Disorders: Randomized Controlled Trial %A ter Huurne,Elke D %A de Haan,Hein A %A Postel,Marloes G %A van der Palen,Job %A VanDerNagel,Joanne EL %A DeJong,Cornelis AJ %+ Tactus Addiction Treatment, Raiffeisenstraat 75, Enschede, 7514 AM, Netherlands, 31 883822887, e.terhuurne@tactus.nl %K eating disorders %K bulimia nervosa %K binge-eating disorder %K eating disorders not otherwise specified %K randomized controlled trial %K eHealth %K Web-based treatment %K asynchronous therapeutic support %K treatment effectiveness %K cognitive behavioral therapy %D 2015 %7 18.06.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Many patients with eating disorders do not receive help for their symptoms, even though these disorders have severe morbidity. The Internet may offer alternative low-threshold treatment interventions. Objective: This study evaluated the effects of a Web-based cognitive behavioral therapy (CBT) intervention using intensive asynchronous therapeutic support to improve eating disorder psychopathology, and to reduce body dissatisfaction and related health problems among patients with eating disorders. Methods: A two-arm open randomized controlled trial comparing a Web-based CBT intervention to a waiting list control condition (WL) was carried out among female patients with bulimia nervosa (BN), binge eating disorder (BED), and eating disorders not otherwise specified (EDNOS). The eating disorder diagnosis was in accordance with the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, and was established based on participants’ self-report. Participants were recruited from an open-access website, and the intervention consisted of a structured two-part program within a secure Web-based application. The aim of the first part was to analyze participant’s eating attitudes and behaviors, while the second part focused on behavioral change. Participants had asynchronous contact with a personal therapist twice a week, solely via the Internet. Self-report measures of eating disorder psychopathology (primary outcome), body dissatisfaction, physical health, mental health, self-esteem, quality of life, and social functioning were completed at baseline and posttest. Results: A total of 214 participants were randomized to either the Web-based CBT group (n=108) or to the WL group (n=106) stratified by type of eating disorder (BN: n=44; BED: n=85; EDNOS: n=85). Study attrition was low with 94% of the participants completing the posttest assignment. Overall, Web-based CBT showed a significant improvement over time for eating disorder psychopathology (F97=63.07, P<.001, d=.82) and all secondary outcome measures (effect sizes between d=.34 to d=.49), except for Body Mass Index. WL participants also improved on most outcomes; however, effects were smaller in this group with significant between-group effects for eating disorder psychopathology (F201=9.42, P=.002, d=.44), body dissatisfaction (F201=13.16, P<.001, d=.42), physical health (F200=12.55, P<.001, d=.28), mental health (F203=4.88, P=.028, d=.24), self-esteem (F202=5.06, P=.026, d=.20), and social functioning (F205=7.93, P=.005, d=.29). Analyses for the individual subgroups BN, BED, and EDNOS showed that eating disorder psychopathology improved significantly over time among Web-based CBT participants in all three subgroups; however, the between-group effect was significant only for participants with BED (F78=4.25, P=.043, d=.61). Conclusions: Web-based CBT proved to be effective in improving eating disorder psychopathology and related health among female patients with eating disorders. Trial Registration: Nederlands Trial Register (NTR): NTR2415; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2415 (Archived by WebCite at http://www.webcitation.org/6T2io3DnJ). %M 26088580 %R 10.2196/jmir.3946 %U http://www.jmir.org/2015/6/e152/ %U https://doi.org/10.2196/jmir.3946 %U http://www.ncbi.nlm.nih.gov/pubmed/26088580 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 6 %P e153 %T Telemonitoring and Mobile Phone-Based Health Coaching Among Finnish Diabetic and Heart Disease Patients: Randomized Controlled Trial %A Karhula,Tuula %A Vuorinen,Anna-Leena %A Rääpysjärvi,Katja %A Pakanen,Mira %A Itkonen,Pentti %A Tepponen,Merja %A Junno,Ulla-Maija %A Jokinen,Tapio %A van Gils,Mark %A Lähteenmäki,Jaakko %A Kohtamäki,Kari %A Saranummi,Niilo %+ VTT Technical Research Centre of Finland, PO Box 1300, Tampere, FI-33101, Finland, 358 408485966, anna-leena.vuorinen@vtt.fi %K health coaching %K telemonitoring %K type 2 diabetes %K heart disease %K personal health record %K health-related quality of life %D 2015 %7 17.06.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: There is a strong will and need to find alternative models of health care delivery driven by the ever-increasing burden of chronic diseases. Objective: The purpose of this 1-year trial was to study whether a structured mobile phone-based health coaching program, which was supported by a remote monitoring system, could be used to improve the health-related quality of life (HRQL) and/or the clinical measures of type 2 diabetes and heart disease patients. Methods: A randomized controlled trial was conducted among type 2 diabetes patients and heart disease patients of the South Karelia Social and Health Care District. Patients were recruited by sending invitations to randomly selected patients using the electronic health records system. Health coaches called patients every 4 to 6 weeks and patients were encouraged to self-monitor their weight, blood pressure, blood glucose (diabetics), and steps (heart disease patients) once per week. The primary outcome was HRQL measured by the Short Form (36) Health Survey (SF-36) and glycosylated hemoglobin (HbA1c) among diabetic patients. The clinical measures assessed were blood pressure, weight, waist circumference, and lipid levels. Results: A total of 267 heart patients and 250 diabetes patients started in the trial, of which 246 and 225 patients concluded the end-point assessments, respectively. Withdrawal from the study was associated with the patients’ unfamiliarity with mobile phones—of the 41 dropouts, 85% (11/13) of the heart disease patients and 88% (14/16) of the diabetes patients were familiar with mobile phones, whereas the corresponding percentages were 97.1% (231/238) and 98.6% (208/211), respectively, among the rest of the patients (P=.02 and P=.004). Withdrawal was also associated with heart disease patients’ comorbidities—40% (8/20) of the dropouts had at least one comorbidity, whereas the corresponding percentage was 18.9% (47/249) among the rest of the patients (P=.02). The intervention showed no statistically significant benefits over the current practice with regard to health-related quality of life—heart disease patients: beta=0.730 (P=.36) for the physical component score and beta=-0.608 (P=.62) for the mental component score; diabetes patients: beta=0.875 (P=.85) for the physical component score and beta=-0.770 (P=.52) for the mental component score. There was a significant difference in waist circumference in the type 2 diabetes group (beta=-1.711, P=.01). There were no differences in any other outcome variables. Conclusions: A health coaching program supported with telemonitoring did not improve heart disease patients' or diabetes patients' quality of life or their clinical condition. There were indications that the intervention had a differential effect on heart patients and diabetes patients. Diabetes patients may be more prone to benefit from this kind of intervention. This should not be neglected when developing new ways for self-management of chronic diseases. Trial Registration: ClinicalTrials.gov NCT01310491; http://clinicaltrials.gov/ct2/show/NCT01310491 (Archived by WebCite at http://www.webcitation.org/6Z8l5FwAM). %M 26084979 %R 10.2196/jmir.4059 %U http://www.jmir.org/2015/6/e153/ %U https://doi.org/10.2196/jmir.4059 %U http://www.ncbi.nlm.nih.gov/pubmed/26084979 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 6 %P e139 %T Computerized Cognitive Behavior Therapy for Anxiety and Depression in Rural Areas: A Systematic Review %A Vallury,Kari Dee %A Jones,Martin %A Oosterbroek,Chloe %+ Department of Rural Health (DRH), Division of Health Sciences, University of South Australia, Department of Rural Health, 111 Nicolson Avenue, Whyalla Norrie, 5608, Australia, 61 0433773061, kari.vallury@unisa.edu.au %K eHealth %K mHealth %K depression %K anxiety %K cognitive therapy %K rural health %K mental health %D 2015 %7 05.06.2015 %9 Review %J J Med Internet Res %G English %X Background: People living in rural and remote communities have greater difficulty accessing mental health services and evidence-based therapies, such as cognitive behavior therapy (CBT), than their urban counterparts. Computerized CBT (CCBT) can be used to effectively treat depression and anxiety and may be particularly useful in rural settings where there are a lack of suitably trained practitioners. Objective: To systematically review the global evidence regarding the clinical effectiveness and acceptability of CCBT interventions for anxiety and/or depression for people living in rural and remote locations. Methods: We searched seven online databases: Medline, Embase Classic and Embase, PsycINFO, CINAHL, Web of Science, Scopus, and the Cochrane Library. We also hand searched reference lists, Internet search engines, and trial protocols. Two stages of selection were undertaken. In the first, the three authors screened citations. Studies were retained if they reported the efficacy, effectiveness or acceptability of CCBT for depression and/or anxiety disorders, were peer reviewed, and written in English. The qualitative data analysis software, NVivo 10, was then used to run automated text searches for the word “rural,” its synonyms, and stemmed words. All studies identified were read in full and were included in the study if they measured or meaningfully discussed the efficacy or acceptability of CCBT among rural participants. Results: A total of 2594 studies were identified, of which 11 met the selection criteria and were included in the review. The studies that disaggregated efficacy data by location of participant reported that CCBT was equally effective for rural and urban participants. Rural location was found to both positively and negatively predict adherence across studies. CCBT may be more acceptable among rural than urban participants—studies to date showed that rural participants were less likely to want more face-to-face contact with a practitioner and found that computerized delivery addressed confidentiality concerns. Conclusions: CCBT can be effective for addressing depression and anxiety and is acceptable among rural participants. Further work is required to confirm these results across a wider range of countries, and to determine the most feasible model of CCBT delivery, in partnership with people who live and work in rural and remote communities. %M 26048193 %R 10.2196/jmir.4145 %U http://www.jmir.org/2015/6/e139/ %U https://doi.org/10.2196/jmir.4145 %U http://www.ncbi.nlm.nih.gov/pubmed/26048193 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 6 %P e136 %T Exposure to a Patient-Centered, Web-Based Intervention for Managing Cancer Symptom and Quality of Life Issues: Impact on Symptom Distress %A Berry,Donna L %A Blonquist,Traci M %A Patel,Rupa A %A Halpenny,Barbara %A McReynolds,Justin %+ Phyllis F Cantor Center, Dana-Farber Cancer Institute, 450 Brookline Ave; LW 518, Boston, MA, 02215, United States, 1 617 632 1909, donna_berry@dfci.harvard.edu %K patient-centered technology %K cancer %K symptoms %K quality of life %K eHealth %K Internet %D 2015 %7 03.06.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Effective eHealth interventions can benefit a large number of patients with content intended to support self-care and management of both chronic and acute conditions. Even though usage statistics are easily logged in most eHealth interventions, usage or exposure has rarely been reported in trials, let alone studied in relationship to effectiveness. Objective: The intent of the study was to evaluate use of a fully automated, Web-based program, the Electronic Self Report Assessment-Cancer (ESRA-C), and how delivery and total use of the intervention may have affected cancer symptom distress. Methods: Patients at two cancer centers used ESRA-C to self-report symptom and quality of life (SxQOL) issues during therapy. Participants were randomized to ESRA-C assessment only (control) or the ESRA-C intervention delivered via the Internet to patients’ homes or to a tablet at the clinic. The intervention enabled participants to self-monitor SxQOL and receive self-care education and customized coaching on how to report concerns to clinicians. Overall and voluntary intervention use were defined as having ≥2 exposures, and one non-prompted exposure to the intervention, respectively. Factors associated with intervention use were explored with Fisher’s exact test. Propensity score matching was used to select a sample of control participants similar to intervention participants who used the intervention. Analysis of covariance (ANCOVA) was used to compare change in Symptom Distress Scale (SDS-15) scores from pre-treatment to end-of-study by groups in the matched sample. Results: Radiation oncology participants used the intervention, overall and voluntarily, more than medical oncology and transplant participants. Participants who were working and had more than a high school education voluntarily used the intervention more. The SDS-15 score was reduced by an estimated 1.53 points (P=.01) in the intervention group users compared to the matched control group. Conclusions: The intended effects of a Web-based, patient-centered intervention on cancer symptom distress were modified by intervention use frequency. Clinical and personal demographics influenced voluntary use. Trial Registration: Clinicaltrials.gov NCT00852852; http://clinicaltrials.gov/ct2/show/NCT00852852 (Archived by WebCite at http://www.webcitation.org/6YwAfwWl7). %M 26041682 %R 10.2196/jmir.4190 %U http://www.jmir.org/2015/6/e136/ %U https://doi.org/10.2196/jmir.4190 %U http://www.ncbi.nlm.nih.gov/pubmed/26041682 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 5 %P e118 %T Behavior Change Techniques in Popular Alcohol Reduction Apps: Content Analysis %A Crane,David %A Garnett,Claire %A Brown,James %A West,Robert %A Michie,Susan %+ Department of Clinical, Educational and Health Psychology, University College London, 1 -19 Torrington Place, London, WC1E 7HB, United Kingdom, 44 20 7687 0723, david.crane.13@ucl.ac.uk %K alcohol %K behaviour change %K mHealth %K smartphone %K iPhone %K android %K apps %K digital %K intervention %D 2015 %7 14.05.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Mobile phone apps have the potential to reduce excessive alcohol consumption cost-effectively. Although hundreds of alcohol-related apps are available, there is little information about the behavior change techniques (BCTs) they contain, or the extent to which they are based on evidence or theory and how this relates to their popularity and user ratings. Objective: Our aim was to assess the proportion of popular alcohol-related apps available in the United Kingdom that focus on alcohol reduction, identify the BCTs they contain, and explore whether BCTs or the mention of theory or evidence is associated with app popularity and user ratings. Methods: We searched the iTunes and Google Play stores with the terms “alcohol” and “drink”, and the first 800 results were classified into alcohol reduction, entertainment, or blood alcohol content measurement. Of those classified as alcohol reduction, all free apps and the top 10 paid apps were coded for BCTs and for reference to evidence or theory. Measures of popularity and user ratings were extracted. Results: Of the 800 apps identified, 662 were unique. Of these, 13.7% (91/662) were classified as alcohol reduction (95% CI 11.3-16.6), 53.9% (357/662) entertainment (95% CI 50.1-57.7), 18.9% (125/662) blood alcohol content measurement (95% CI 16.1-22.0) and 13.4% (89/662) other (95% CI 11.1-16.3). The 51 free alcohol reduction apps and the top 10 paid apps contained a mean of 3.6 BCTs (SD 3.4), with approximately 12% (7/61) not including any BCTs. The BCTs used most often were “facilitate self-recording” (54%, 33/61), “provide information on consequences of excessive alcohol use and drinking cessation” (43%, 26/61), “provide feedback on performance” (41%, 25/61), “give options for additional and later support” (25%, 15/61) and “offer/direct towards appropriate written materials” (23%, 14/61). These apps also rarely included any of the 22 BCTs frequently used in other health behavior change interventions (mean 2.46, SD 2.06). Evidence was mentioned by 16.4% of apps, and theory was not mentioned by any app. Multivariable regression showed that apps including advice on environmental restructuring were associated with lower user ratings (Β=-46.61, P=.04, 95% CI -91.77 to -1.45) and that both the techniques of “advise on/facilitate the use of social support” (Β=2549.21, P=.04, 95% CI 96.75-5001.67) and the mention of evidence (Β=1376.74, P=.02, 95%, CI 208.62-2544.86) were associated with the popularity of the app. Conclusions: Only a minority of alcohol-related apps promoted health while the majority implicitly or explicitly promoted the use of alcohol. Alcohol-related apps that promoted health contained few BCTs and none referred to theory. The mention of evidence was associated with more popular apps, but popularity and user ratings were only weakly associated with the BCT content. %M 25977135 %R 10.2196/jmir.4060 %U http://www.jmir.org/2015/5/e118/ %U https://doi.org/10.2196/jmir.4060 %U http://www.ncbi.nlm.nih.gov/pubmed/25977135 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 2 %P e54 %T Men’s Responses to Online Smoking Cessation Resources for New Fathers: The Influence of Masculinities %A Bottorff,Joan L %A Oliffe,John L %A Sarbit,Gayl %A Kelly,Mary Theresa %A Cloherty,Alexandra %+ Institute for Healthy Living and Chronic Disease Prevention, University of British Columbia, 1147 Research Road ART, Kelowna, BC, V1V 1V7, Canada, 1 250 807 8627, joan.bottorff@ubc.ca %K Cancer prevention %K smoking cessation %K gender %K men’s health promotion %K fathers %K oncology %D 2015 %7 13.05.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Smoking cessation is the single most important step to preventing cancer. Drawing on previous research, Web-based resources were developed to complement a program to support expectant and new fathers to quit smoking. Objective: The objectives of this research were to: (1) describe the responses of expectant and new fathers who smoke or had recently quit smoking to the website resources, and (2) explore how masculinities shape men’s responses to and experiences with online smoking cessation resources. Methods: Using semi-structured, individual face-to-face interviews, the Dads in Gear Web-based resources were reviewed and evaluated by 20 new fathers who smoked or had recently quit smoking. The data were transcribed and analyzed using NVivo 8 qualitative data analysis software. Results: We describe the fathers’ reactions to various components of the website, making connections between masculinities and fathering within 5 themes: (1) Fathering counts: gender-specific parenting resources; (2) Measuring up: bolstering masculine identities as fathers; (3) Money matters: triggering masculine virtues related to family finances; (4) Masculine ideals: father role models as cessation aids; and (5) Manly moves: physical activity for the male body. Conclusions: A focus on fathering was an effective draw for men to the smoking cessation resources. The findings provide direction for considering how best to do virtual cessation programs as well as other types of online cancer prevention programs for men. %M 25971202 %R 10.2196/resprot.4079 %U http://www.researchprotocols.org/2015/2/e54/ %U https://doi.org/10.2196/resprot.4079 %U http://www.ncbi.nlm.nih.gov/pubmed/25971202 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 5 %P e116 %T Effectiveness of a Blended Web-Based Intervention on Return to Work for Sick-Listed Employees With Common Mental Disorders: Results of a Cluster Randomized Controlled Trial %A Volker,Daniëlle %A Zijlstra-Vlasveld,Moniek C %A Anema,Johannes R %A Beekman,Aartjan TF %A Brouwers,Evelien PM %A Emons,Wilco HM %A van Lomwel,A Gijsbert C %A van der Feltz-Cornelis,Christina M %+ Trimbos Institute, Netherlands institute of mental health and addiction, Da Costakade 45, Utrecht, 3500 AS, Netherlands, 31 30 2959287, dvolker@trimbos.nl %K occupational health %K randomized controlled trial %K mental health %K depression %K anxiety %K sick leave %D 2015 %7 13.05.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Common mental disorders are strongly associated with long-term sickness absence, which has negative consequences for the individual employee’s quality of life and leads to substantial costs for society. It is important to focus on return to work (RTW) during treatment of sick-listed employees with common mental disorders. Factors such as self-efficacy and the intention to resume work despite having symptoms are important in the RTW process. We developed “E-health module embedded in Collaborative Occupational health care” (ECO) as a blended Web-based intervention with 2 parts: an eHealth module (Return@Work) for the employee aimed at changing cognitions of the employee regarding RTW and a decision aid via email supporting the occupational physician with advice regarding treatment and referral options based on monitoring the employee’s progress during treatment. Objective: This study evaluated the effect of a blended eHealth intervention (ECO) versus care as usual on time to RTW of sick-listed employees with common mental disorders. Methods: The study was a 2-armed cluster randomized controlled trial. Employees sick-listed between 4 and 26 weeks with common mental disorder symptoms were recruited by their occupational health service or employer. The employees were followed up to 12 months. The primary outcome measures were time to first RTW (partial or full) and time to full RTW. Secondary outcomes were response and remission of the common mental disorder symptoms (self-assessed). Results: A total of 220 employees were included: 131 participants were randomized to the ECO intervention and 89 to care as usual (CAU). The duration until first RTW differed significantly between the groups. The median duration was 77.0 (IQR 29.0-152.3) days in the CAU group and 50.0 (IQR 20.8-99.0) days in the ECO group (hazard ratio [HR] 1.390, 95% CI 1.034-1.870, P=.03). No significant difference was found for duration until full RTW. Treatment response of common mental disorder symptoms did not differ significantly between the groups, but at 9 months after baseline significantly more participants in the ECO group achieved remission than in the CAU group (OR 2.228, 95% CI 1.115-4.453, P=.02). Conclusions: The results of this study showed that in a group of sick-listed employees with common mental disorders, applying the blended eHealth ECO intervention led to faster first RTW and more remission of common mental disorder symptoms than CAU. Trial Registration: Netherlands Trial Register NTR2108; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2108. (Archived by WebCite at http://www.webcitation.org/6YBSnNx3P). %M 25972279 %R 10.2196/jmir.4097 %U http://www.jmir.org/2015/5/e116/ %U https://doi.org/10.2196/jmir.4097 %U http://www.ncbi.nlm.nih.gov/pubmed/25972279 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 5 %P e117 %T A Web-Based Psychoeducational Program for Informal Caregivers of Patients With Alzheimer’s Disease: A Pilot Randomized Controlled Trial %A Cristancho-Lacroix,Victoria %A Wrobel,Jérémy %A Cantegreil-Kallen,Inge %A Dub,Timothée %A Rouquette,Alexandra %A Rigaud,Anne-Sophie %+ Assistance Publique - Hôpitaux de Paris, Department of Gerontology, Hôpital Broca, 54-56 rue Pascal, Paris, 75013, France, 33 33144083351, victoria.cristancho@gmail.com %K family caregivers %K psychological education %K eHealth %K Alzheimer disease %K emotional stress %K qualitative research %K Internet %K randomized controlled trials %D 2015 %7 12.05.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Although several face-to-face programs are dedicated to informal caregivers of persons with dementia, they are not always accessible to overburdened or isolated caregivers. Based on a face-to-face intervention program, we adapted and designed a Web-based fully automated psychoeducational program (called Diapason) inspired by a cognitive approach. Objective: This study aimed to evaluate through a pilot unblinded randomized controlled trial the efficacy and acceptability of a Web-based psychoeducational program for informal caregivers of persons with Alzheimer’s disease (PWAD) based on a mixed methods research design. Methods: We recruited and randomized offline 49 informal caregivers of a PWAD in a day care center in Paris, France. They either received the Web-based intervention and usual care for 3 months (experimental group, n=25) or only usual care (control group, n=24). Caregivers’ perceived stress (PSS-14, primary outcome), self-efficacy, burden, perceived health status, and depression (secondary outcomes) were measured during 3 face-to-face on-site visits: at baseline, at the end of the program (month 3), and after follow-up (month 6). Additionally, semistructured interviews were conducted with experimental group caregivers at month 6 and examined with thematic analysis. Results: Intention-to-treat analysis did not show significant differences in self-perceived stress between the experimental and control groups (P=.98). The experimental group significantly improved their knowledge of the illness (d=.79, P=.008) from baseline to month 3. Of the 25 participants allocated to the experimental group, 17 (71%) finished the protocol and entirely viewed at least 10 of 12 online sessions. On average, participants used the website 19.72 times (SD 12.88) and were connected for 262.20 minutes (SD 270.74). The results of the satisfaction questionnaire showed that most participants considered the program to be useful (95%, 19/20), clear (100%, 20/20), and comprehensive (85%, 17/20). Significant correlations were found between relationship and caregivers’ program opinion (P=.01). Thus, positive opinions were provided by husbands and sons (3/3), whereas qualified opinions were primarily reported by daughters (8/11). Female spouses expressed negative (2/3) or neutral opinions (1/3). Caregivers expected more dynamic content and further interaction with staff and peers. Conclusions: In this study, quantitative results were inconclusive owing to small sample size. Qualitative results indicated/showed little acceptance of the program and high expectations from caregivers. Caregivers did not rule out their interest in this kind of intervention provided that it met their needs. More dynamic, personalized, and social interventions are desirable. Our recruitment issues pointed out the necessity of in-depth studies about caregivers’ help-seeking behaviors and readiness factors. Trial Registration: Clinicaltrials.gov NCT01430286; http://clinicaltrials.gov/ct2/show/NCT01430286 (Archived by WebCite at http://www.webcitation/6KxHaRspL). %M 25967983 %R 10.2196/jmir.3717 %U http://www.jmir.org/2015/5/e117/ %U https://doi.org/10.2196/jmir.3717 %U http://www.ncbi.nlm.nih.gov/pubmed/25967983 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 5 %P e115 %T Who Follows eHealth Interventions as Recommended? A Study of Participants' Personal Characteristics From the Experimental Arm of a Randomized Controlled Trial %A Reinwand,Dominique A %A Schulz,Daniela N %A Crutzen,Rik %A Kremers,Stef PJ %A de Vries,Hein %+ CAPHRI School for Public Health and Primary Care, Department of Health Promotion, Maastricht University, P Debyeplein 1, Maastricht, 6229 HA, Netherlands, 31 433882435, d.reinwand@maastrichtuniversity.nl %K eHealth %K Web-based intervention %K intervention use %K computer tailoring %K personal characteristics %K health lifestyle %K multiple health behaviors %K intervention adherence %K socioeconomic status %D 2015 %7 11.05.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Computer-tailored eHealth interventions to improve health behavior have been demonstrated to be effective and cost-effective if they are used as recommended. However, different subgroups may use the Internet differently, which might also affect intervention use and effectiveness. To date, there is little research available depicting whether adherence to intervention recommendations differs according to personal characteristics. Objective: The aim was to assess which personal characteristics are associated with using an eHealth intervention as recommended. Methods: A randomized controlled trial was conducted among a sample of the adult Dutch population (N=1638) testing an intervention aimed at improving 5 healthy lifestyle behaviors: increasing fruit and vegetable consumption, increasing physical activity, reducing alcohol intake, and promoting smoking cessation. Participants were asked to participate in those specific online modules for which they did not meet the national guideline(s) for the respective behavior(s). Participants who started with fewer than the recommended number of modules of the intervention were defined as users who did not follow the intervention recommendation. Results: The fewer modules recommended to participants, the better participants adhered to the intervention modules. Following the intervention recommendation increased when participants were older (χ21=39.8, P<.001), female (χ21=15.8, P<.001), unemployed (χ21=7.9, P=.003), ill (χ21=4.5, P=.02), or in a relationship (χ21=7.8, P=.003). No significant relevant differences were found between groups with different levels of education, incomes, or quality of life. Conclusion: Our findings indicate that eHealth interventions were used differently by subgroups. The more frequent as-recommended intervention use by unemployed, older, and ill participants may be an indication that these eHealth interventions are attractive to people with a greater need for health care information. Further research is necessary to make intervention use more attractive for people with unhealthy lifestyle patterns. %M 25963607 %R 10.2196/jmir.3932 %U http://www.jmir.org/2015/5/e115/ %U https://doi.org/10.2196/jmir.3932 %U http://www.ncbi.nlm.nih.gov/pubmed/25963607 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 5 %P e113 %T Comparative and Cost Effectiveness of Telemedicine Versus Telephone Counseling for Smoking Cessation %A Richter,Kimber P %A Shireman,Theresa I %A Ellerbeck,Edward F %A Cupertino,A Paula %A Catley,Delwyn %A Cox,Lisa Sanderson %A Preacher,Kristopher J %A Spaulding,Ryan %A Mussulman,Laura M %A Nazir,Niaman %A Hunt,Jamie J %A Lambart,Leah %+ University of Kansas Medical Center, Department of Preventive Medicine and Public Health, 3901 Rainbow Boulevard, Kansas City, KS, 66160, United States, 1 9135882718, krichter@kumc.edu %K telemedicine %K Internet %K rural %K smoking cessation, RCT %K primary care %D 2015 %7 08.05.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: In rural America, cigarette smoking is prevalent and health care providers lack the time and resources to help smokers quit. Telephone quitlines are important avenues for cessation services in rural areas, but they are poorly integrated with local health care resources. Objective: The intent of the study was to assess the comparative effectiveness and cost effectiveness of two models for delivering expert tobacco treatment at a distance: telemedicine counseling that was integrated into smokers’ primary care clinics (Integrated Telemedicine—ITM) versus telephone counseling, similar to telephone quitline counseling, delivered to smokers in their homes (Phone). Methods: Smokers (n=566) were recruited offline from 20 primary care and safety net clinics across Kansas. They were randomly assigned to receive 4 sessions of ITM or 4 sessions of Phone counseling. Patients in ITM received real-time video counseling, similar to Skype, delivered by computer/webcams in clinic exam rooms. Three full-time equivalent trained counselors delivered the counseling. The counseling duration and content was the same in both groups and was available in Spanish or English. Both groups also received identical materials and assistance in selecting and obtaining cessation medications. The primary outcome was verified 7-day point prevalence smoking abstinence at month 12, using an intent-to-treat analysis. Results: There were no significant baseline differences between groups, and the trial achieved 88% follow-up at 12 months. Verified abstinence at 12 months did not significantly differ between ITM or Phone (9.8%, 27/280 vs 12%, 34/286; P=.406). Phone participants completed somewhat more counseling sessions than ITM (mean 2.6, SD 1.5 vs mean 2.4, SD 1.5; P=.0837); however, participants in ITM were significantly more likely to use cessation medications than participants in Phone (55.9%, 128/280 vs 46.1%, 107/286; P=.03). Compared to Phone participants, ITM participants were significantly more likely to recommend the program to a family member or friend (P=.0075). From the combined provider plus participant (societal) perspective, Phone was significantly less costly than ITM. Participants in ITM had to incur time and mileage costs to travel to clinics for ITM sessions. From the provider perspective, counseling costs were similar between ITM (US $45.46, SD 31.50) and Phone (US $49.58, SD 33.35); however, total provider costs varied widely depending on how the clinic space for delivering ITM was valued. Conclusions: Findings did not support the superiority of ITM over telephone counseling for helping rural patients quit smoking. ITM increased utilization of cessation pharmacotherapy and produced higher participant satisfaction, but Phone counseling was significantly less expensive. Future interventions could combine elements of both approaches to optimize pharmacotherapy utilization, counseling adherence, and satisfaction. Such an approach could commence with a telemedicine-delivered clinic office visit for pharmacotherapy guidance, and continue with telephone or real-time video counseling delivered via mobile phones to flexibly deliver behavioral support to patients where they most need it—in their homes and communities. Trial Registration: Clinicaltrials.gov NCT00843505; http://clinicaltrials.gov/ct2/show/NCT00843505 (Archived by WebCite at http://www.webcitation.org/6YKSinVZ9). %R 10.2196/jmir.3975 %U http://www.jmir.org/2015/5/e113/ %U https://doi.org/10.2196/jmir.3975 %0 Journal Article %@ 2292-9495 %I Gunther Eysenbach %V 2 %N 1 %P e7 %T Usability Testing of an Internet-Based e-Counseling Platform for Adults With Chronic Heart Failure %A Payne,Ada YM %A Surikova,Jelena %A Liu,Sam %A Ross,Heather %A Mechetiuc,Teodora %A Nolan,Robert P %+ Cardiac eHealth, Peter Munk Cardiac Centre, University Health Network, 585 University Ave, 6N-617 NU, Toronto, ON, M5G 2N2, Canada, 1 340 4800 ext 6400, ada.payne@uhnresearch.ca %K chronic heart failure %K self-care behaviors %K e-counseling %K usability assessment %D 2015 %7 08.05.2015 %9 Original Paper %J JMIR Human Factors %G English %X Background: Chronic heart failure (CHF) is a major cause of hospitalization and mortality. In order to maintain heart function and quality of life, patients with CHF need to follow recommended self-care guidelines (ie, eating a heart healthy diet, exercising regularly, taking medications as prescribed, monitoring their symptoms, and living a smoke-free life). Yet, adherence to self-care is poor. We have developed an Internet-based e-Counseling platform, Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure (CHF-CePPORT), that aims to improve self-care adherence and quality of life in people with CHF. Before assessing the efficacy of this e-platform in a multisite, double-blind, randomized controlled trial, we evaluated the usability of the prototype website. Objective: The objective of the study was to assess the usability of the CHF-CePPORT e-Counseling platform in terms of navigation, content, and layout. Methods: CHF patients were purposively sampled from the Heart Function Clinic at the Peter Munk Cardiac Center, University Health Network, to participate in this study. We asked the consented participants to perform specific tasks on the website. These tasks included watching self-help videos and reviewing content as directed. Their interactions with the website were captured using the “think aloud” protocol. After completing the tasks, research personnel conducted a semi-structured interview with each participant to assess their experience with the website. Content analysis of the transcripts from the “think aloud” sessions and the interviews was conducted to identify themes related to navigation, content, and layout of the website. Descriptive statistics were used to summarize the satisfaction data. Results: A total of 7 men and women (ages 39-77) participated in 2 iterative rounds of testing. Overall, all participants were very satisfied with the content and layout of the website. They reported that the content was helpful to their management of CHF and that it reflected their experiences in coping with CHF. The layout was professional and friendly. The use of videos made the learning process entertaining. However, they experienced many navigation errors in the first round of testing. For example, some participants were not sure how to navigate across a series of Web pages. Based on the experiences that were reported in the first round, we made several changes to the navigation structure. This included using large navigation buttons to direct users to each section and providing tutorial videos to familiarize users with our website. We assessed whether these changes improved user navigation in the second round of testing. The major finding is that participants made fewer navigation errors and they did not identify any new problems. Conclusions: We found evidence to support the usability of our CHF-CePPORT e-Counseling platform. Our findings highlight the importance of a clear and easy-to-follow navigation structure on user experience. %M 27026267 %R 10.2196/humanfactors.4125 %U http://humanfactors.jmir.org/2015/1/e7/ %U https://doi.org/10.2196/humanfactors.4125 %U http://www.ncbi.nlm.nih.gov/pubmed/27026267 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 5 %P e108 %T Childcare Service Centers’ Preferences and Intentions to Use a Web-Based Program to Implement Healthy Eating and Physical Activity Policies and Practices: A Cross-Sectional Study %A Yoong,Sze Lin %A Williams,Christopher Michael %A Finch,Meghan %A Wyse,Rebecca %A Jones,Jannah %A Freund,Megan %A Wiggers,John Henry %A Nathan,Nicole %A Dodds,Pennie %A Wolfenden,Luke %+ Hunter New England Local Health District, Hunter New England Population Health, Longworth Avenue, Wallsend, 2287, Australia, 61 249296413, serene.yoong@hnehealth.nsw.gov.au %K obesity %K long day care centers %K childcare centers %K guideline adherence %D 2015 %7 30.04.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Overweight and obesity is a significant public health problem that impacts a large number of children globally. Supporting childcare centers to deliver healthy eating and physical activity-promoting policies and practices is a recommended strategy for obesity prevention, given that such services provide access to a substantial proportion of children during a key developmental period. Electronic Web-based interventions represent a novel way to support childcare service providers to implement such policies and practices. Objective: This study aimed to assess: (1) childcare centers’ current use of technology, (2) factors associated with intention to use electronic Web-based interventions, and (3) Web-based features that managers rated as useful to support staff with implementing healthy eating and physical activity-promoting policies and practices. Methods: A computer-assisted telephone interview (CATI) was conducted with service managers from long day care centers and preschools. The CATI assessed the following: (1) childcare center characteristics, (2) childcare centers’ use of electronic devices, (3) intention to use a hypothetical electronic Web-based program—assessed using the Technology Acceptance Model (TAM) with ratings between 1 (strongly disagree) and 7 (strongly agree), and (4) features rated as useful to include in a Web-based program. Results: Overall, 214 service centers out of 277 (77.3%) consented to participate. All service centers except 2 reported using computers (212/214, 99.1%), whereas 40.2% (86/214) used portable tablets. A total of 71.9% (151/210) of childcare service managers reported a score of 6 or more for intention to use a hypothetical electronic Web-based program. In a multivariable logistic regression analysis, intention to use the program was significantly associated with perceived ease of use (P=.002, odds ratio [OR] 3.9, 95% CI 1.6-9.2) and perceived usefulness (P<.001, OR 28,95% CI 8.0-95.2). Features reported by service managers as useful or very useful for a Web-based program included decision-support tools to support staff with menu planning (117/129, 90.7%), links to relevant resources (212/212, 100%), updated information on guidelines (208/212, 98.1%), and feedback regarding childcare center performance in relation to other childcare centers (212/212, 100%). Conclusions: Childcare service managers reported high intention to use a Web-based program and identified several useful features to support staff to implement healthy eating and physical activity policies and practices. Further descriptive and intervention research examining the development and use of such a program to support childcare centers with the implementation of healthy eating and physical activity-promoting policies and practices is warranted. %M 25931430 %R 10.2196/jmir.3639 %U http://www.jmir.org/2015/5/e108/ %U https://doi.org/10.2196/jmir.3639 %U http://www.ncbi.nlm.nih.gov/pubmed/25931430 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 4 %P e105 %T Six-Month Outcomes of a Web-Based Intervention for Users of Amphetamine-Type Stimulants: Randomized Controlled Trial %A Tait,Robert J %A McKetin,Rebecca %A Kay-Lambkin,Frances %A Carron-Arthur,Bradley %A Bennett,Anthony %A Bennett,Kylie %A Christensen,Helen %A Griffiths,Kathleen M %+ National Drug Research Institute, Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, 6845, Australia, 61 8 92661610, robert.tait@curtin.edu.au %K amphetamine-related disorders %K Internet %K randomized controlled trial %K intervention studies %K cognitive therapy %D 2015 %7 29.04.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: The use of amphetamine-type stimulants (ATS) places a large burden on health services. Objective: The aim was to evaluate the effectiveness of a self-guided Web-based intervention (“breakingtheice”) for ATS users over 6 months via a free-to-access site. Methods: We conducted a randomized trial comparing a waitlist control with a fully automated intervention containing 3 modules derived from cognitive behavioral therapy and motivation enhancement. The main outcome was self-reported ATS use in the past 3 months assessed at 3- and 6-month follow-ups using the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). Secondary outcomes were help-seeking intentions (general help-seeking questionnaire), actual help seeking (actual help-seeking questionnaire), psychological distress (Kessler 10), polydrug use (ASSIST), quality of life (European Health Interview Survey), days out of role, and readiness to change. Follow-up data were evaluated using an intention-to-treat (ITT) analysis with a group by time interaction. Results: We randomized 160 people (intervention: n=81; control: n=79). At 6 months, 38 of 81 (47%) intervention and 41 of 79 (52%) control participants provided data. ATS scores significantly declined for both groups, but the interaction effect was not significant. There were significant ITT time by group interactions for actual help seeking (rate ratio [RR] 2.16; d=0.45) and help-seeking intentions (RR 1.17; d=0.32), with help seeking increasing for the intervention group and declining for the control group. There were also significant interactions for days completely (RR 0.50) and partially (RR 0.74) out of role favoring the intervention group. However, 37% (30/81) of the intervention group did not complete even 1 module. Conclusions: This self-guided Web-based intervention encouraged help seeking associated with ATS use and reduced days out of role, but it did not reduce ATS use. Thus, this program provides a means of engaging with some sections of a difficult-to-reach group to encourage treatment, but a substantial minority remained disengaged. Trial Registration: Australian and New Zealand Clinical Trials Registry: ACTRN12611000947909; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=343307 (Archived by WebCite at http://www.webcitation.org/6Y0PGGp8q). %M 25925801 %R 10.2196/jmir.3778 %U http://www.jmir.org/2015/4/e105/ %U https://doi.org/10.2196/jmir.3778 %U http://www.ncbi.nlm.nih.gov/pubmed/25925801 %0 Journal Article %@ 2368-7959 %I JMIR Publications Inc. %V 2 %N 2 %P e13 %T Effectiveness of Computer-Assisted Therapy for Substance Dependence Using Breaking Free Online: Subgroup Analyses of a Heterogeneous Sample of Service Users %A Elison,Sarah %A Davies,Glyn %A Ward,Jonathan %+ Breaking Free Online, 274 Deansgate, Manchester, M3 4JB, United Kingdom, 44 0161 834 ext 4647, selison@breakingfreegroup.com %K substance misuse %K computer-assisted therapy %K treatment %K psychosocial interventions %D 2015 %7 23.04.2015 %9 Original Paper %J JMIR Mental Health %G English %X Background: Substance misuse services within the United Kingdom have traditionally been oriented to opiate and crack users, and attended predominantly by male service users. Groups who do not fit this demographic, such as women or those whose primary drug of choice is neither heroin nor crack, have tended to be underrepresented in services. In addition, there can be stigma associated with traditional opiate and crack-centric services. Therefore, the computerized treatment and recovery program, Breaking Free Online (BFO), was developed to enable service users to access confidential support for dependence on a wide range of substances. BFO is delivered as computer-assisted therapy (CAT), or, where appropriate, used as self-help. Objective: The aim of this study was to report psychometric outcomes data from 393 service users accessing online support for substance misuse via BFO. Methods: Following initial referral to substance misuse services, all participants were supported in setting up a BFO login by a practitioner or peer mentor, and, where required, assisted as they completed an online baseline assessment battery contained within the BFO program. Following a period of engagement with BFO, all participants completed the same battery of assessments, and changes in the scores on these assessments were examined. Results: Significant improvements were found across the 393 service users in several areas of psychosocial functioning, including quality of life, severity of alcohol and drug dependence, depression, and anxiety (P=<.001 across all aspects of functioning). Additionally, significant improvements were found within specific subgroups of participants, including females (P=.001-<.001), males (P=.004-<.001), service users reporting alcohol dependence (P=.002-<.001), opiate and crack dependence (P=.014-<.001), and those seeking support for other substances that may be less well represented in the substance misuse sector (P=.001-<.001). Conclusions: Data from this study indicates that BFO is an effective clinical treatment for a wide range of individuals requiring support for substance misuse. Further work is currently underway to examine more closely the clinical effectiveness of the program. %M 26543918 %R 10.2196/mental.4355 %U http://mental.jmir.org/2015/2/e13/ %U https://doi.org/10.2196/mental.4355 %U http://www.ncbi.nlm.nih.gov/pubmed/26543918 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 2 %P e44 %T Internet-Based Cognitive Behavioral Therapy for Residual Symptoms in Bipolar Disorder Type II: A Single-Subject Design Pilot Study %A Holländare,Fredrik %A Eriksson,Annsofi %A Lövgren,Lisa %A Humble,Mats B %A Boersma,Katja %+ Psychiatric Research Centre, School of Health and Medical Science, Örebro University, S House, Södra Grev Rosengatan, Örebro, 70116, Sweden, 46 196025890, fredrik.hollandare@orebroll.se %K bipolar disorder %K Internet %K cognitive therapy %K behavioral therapy %K pilot projects %D 2015 %7 23.04.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Bipolar disorder is a chronic condition with recurring episodes that often lead to suffering, decreased functioning, and sick leave. Pharmacotherapy in the form of mood stabilizers is widely available, but does not eliminate the risk of a new depressive or (hypo)manic episode. One way to reduce the risk of future episodes is to combine pharmacological treatment with individual or group psychological interventions. However, access to such interventions is often limited due to a shortage of trained therapists. In unipolar depression there is now robust evidence of the effectiveness of Internet-based psychological interventions, usually comprising psychoeducation and cognitive behavioral therapy (CBT). Internet-based interventions for persons suffering from bipolar disorder could increase access to psychological treatment. Objective: The aim of this study was to investigate the feasibility of an Internet-based intervention, as well as its effect on residual depressive symptoms in persons diagnosed with bipolar disorder type II (BP-II). The most important outcomes were depressive symptoms, treatment adherence, and whether the patient perceived the intervention as helpful. Methods: A total of 7 patients diagnosed with bipolar disorder type II at a Swedish psychiatric outpatient clinic were offered the opportunity to participate. Of the 7 patients, 3 (43%) dropped out before treatment began, and 4 (57%) were treated by means of an online, Internet-based intervention based on CBT (iCBT). The intervention was primarily aimed at psychoeducation, treatment of residual depressive symptoms, emotion regulation, and improved sleep. All patients had ongoing pharmacological treatment at recruitment and established contact with a psychiatrist. The duration of BP-II among the treated patients was between 6 and 31 years. A single-subject design was used and the results of the 4 participating patients were presented individually. Results: Initiating treatment was perceived as too demanding under current life circumstances for 3 patients who consequently dropped out during baseline assessment. Self-ratings using the Montgomery-Åsberg Depression Rating Scale—Self-rated (MADRS-S) showed symptom reduction in 3 (75%) of the 4 treated cases during iCBT. In the evaluation of the treatment, 2 patients reported that they perceived that the treatment had reduced symptoms a little, 1 that it had reduced symptoms very much, and 1 not at all. Treatment adherence (ie, module completion) was fairly high in 3 cases. In general, the modules were perceived as fairly helpful or very helpful by the patients. In one case, there was a reliable change—according to the Reliable Change Index—in self-rated symptoms of depression and perseverative thinking. Conclusions: The treatment seemed to have acceptable feasibility. The iCBT intervention could be an effective way to treat residual symptoms in some patients with bipolar disorder type II. This should be investigated in a larger study. Trial Registration: ClinicalTrials.gov NCT01742351; https://clinicaltrials.gov/ct2/show/NCT01742351 (Archived by WebCite at http://www.webcitation.org/6XnVpv4C3). %M 25908235 %R 10.2196/resprot.3910 %U http://www.researchprotocols.org/2015/2/e44/ %U https://doi.org/10.2196/resprot.3910 %U http://www.ncbi.nlm.nih.gov/pubmed/25908235 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 4 %P e100 %T A Mixed-Methods Study on the Acceptability of Using eHealth for HIV Prevention and Sexual Health Care Among Men Who Have Sex With Men in China %A Muessig,Kathryn E %A Bien,Cedric H %A Wei,Chongyi %A Lo,Elaine J %A Yang,Min %A Tucker,Joseph D %A Yang,Ligang %A Meng,Gang %A Hightow-Weidman,Lisa B %+ Department of Health Behavior, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, 306 Rosenau Hall, Campus Box 7440, Chapel Hill, NC, 27599, United States, 1 919 962 5059, kmuessig@med.unc.edu %K Internet %K HIV %K AIDS %K China %K men who have sex with men %K mixed method %K sexually transmitted diseases %D 2015 %7 21.04.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Human immunodeficiency virus (HIV) infection disproportionately affects men who have sex with men (MSM). Over half of all HIV-positive MSM in China may not know their HIV status. Mobile phones and Web interventions (eHealth) are underutilized resources that show promise for supporting HIV education, testing, and linkage to care. Objective: This mixed-methods study among MSM in China assessed technology utilization and eHealth acceptability for sexual health care. Methods: We conducted in-depth interviews and an online survey. Qualitative analyses informed the development of the Internet survey, which was administered through two popular MSM websites. Bivariate and multivariate analysis assessed characteristics of MSM interested in eHealth for sexual health care. Results: The qualitative sample included MSM across a range of ages, education, marital status, sexuality, and HIV testing experience. Qualitative findings included the importance of the Internet as the primary source of information about sexual health, HIV and other sexually transmitted diseases (STDs), use of the Internet to enable HIV testing opportunities by facilitating connections with both the gay community and health care providers, and mixed perceptions regarding the confidentiality of eHealth tools for sexual health. Among the Internet sample (N=1342), the average age was 30.6 years old, 82.81% (1098/1342) were single, and 53.42% (711/1331) had completed college. In the past 3 months, 38.66% (382/988) had condomless sex and 60.53% (805/1330) self-reported having ever tested for HIV. The majority of men owned computers (94.14%, 1220/1296) and mobile phones (92.32%, 1239/1342), which many had used to search for HIV/STD information and testing sites. In multivariate analysis, interest in using computers or mobile phones to support their sexual health care was associated with being a student, prior use of computers or mobile phones to search for general health information, prior use of computers or mobile phones to search for HIV/STD information, and confidentiality concerns. Conclusions: MSM in this sample had high utilization of technology and interest in eHealth despite confidentiality concerns. Future eHealth interventions can thoughtfully and creatively address these concerns as a priority for successful implementation. %M 25900881 %R 10.2196/jmir.3370 %U http://www.jmir.org/2015/4/e100/ %U https://doi.org/10.2196/jmir.3370 %U http://www.ncbi.nlm.nih.gov/pubmed/25900881 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 4 %P e92 %T Long-Term Outcomes of a Web-Based Diabetes Prevention Program: 2-Year Results of a Single-Arm Longitudinal Study %A Sepah,S Cameron %A Jiang,Luohua %A Peters,Anne L %+ University of California, San Francisco, Department of Psychiatry, 401 Parnassus Ave, Box 0984, San Francisco, CA, 94143, United States, 1 888 987 8337, cameron.sepah@ucsf.edu %K prediabetes %K type 2 diabetes %K obesity %K diabetes prevention program %K internet %K online %K mobile apps %K mhealth %K digital health %K intervention %D 2015 %7 10.04.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital therapeutics are evidence-based behavioral treatments delivered online that can increase accessibility and effectiveness of health care. However, few studies have examined long-term clinical outcomes of digital therapeutics. Objective: The objective of this study was to conduct a 2-year follow-up on participants in the Internet-based Prevent diabetes prevention program pilot study, specifically examining the effects on body weight and A1c, which are risk factors for diabetes development. Methods: A quasi-experimental research design was used, including a single-arm pre- and post-intervention assessment of outcomes. Participants underwent a 16-week weight loss intervention and an ongoing weight maintenance intervention. As part of the program, participants received a wireless scale, which was used to collect body weight data on an ongoing basis. Participants also received A1c test kits at baseline, 0.5 year, 1 year, and 2-year time points. Results: Participants previously diagnosed with prediabetes (n=220) were originally enrolled in the pilot study. A subset of participants (n=187) met Centers for Disease Control and Prevention (CDC) criteria for starting the program (starters), and a further subset (n=155) met CDC criteria for completing the program (completers) and were both included in analyses. Program starters lost an average of 4.7% (SD 0.4) of baseline body weight after 1 year and 4.2% (SD 0.8) after 2 years, and reduced A1c by mean 0.38% (SD 0.07) after 1 year and 0.43% (SD 0.08) after 2 years. Program completers lost mean 4.9% (SD 0.5) of baseline body weight after 1 year and 4.3% (SD 0.8) after 2 years, and reduced A1c by 0.40% (SD 0.07) after 1 year and 0.46% (SD 0.08) after 2 years. For both groups, neither 2-year weight loss nor A1c results were significantly different from 1-year results. Conclusions: Users of the Prevent program experienced significant reductions in body weight and A1c that are maintained after 2 years. Contrary to the expected progression from prediabetes to diabetes over time, average A1c levels continued to show an average regression from within the prediabetic range (5.7%-6.4%) initially to the normal range (<5.7%) after 2 years. Further investigation is warranted to test digital therapeutics as a scalable solution to address national diabetes and cardiovascular disease prevention efforts. %M 25863515 %R 10.2196/jmir.4052 %U http://www.jmir.org/2015/4/e92/ %U https://doi.org/10.2196/jmir.4052 %U http://www.ncbi.nlm.nih.gov/pubmed/25863515 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 4 %P e89 %T The Use of Behavior Change Theory in Internet-Based Asthma Self-Management Interventions: A Systematic Review %A Al-Durra,Mustafa %A Torio,Monika-Bianca %A Cafazzo,Joseph A %+ Centre for Global eHealth Innovation, Techna Institute, University Health Network, Toronto General Hospital, R Fraser Elliott Building, 4th Floor, 190 Elizabeth Street, Toronto, ON, M5G 2C4, Canada, 1 416 340 4800 ext 4765, maldurra@ehealthinnovation.org %K asthma %K self-care %K self-management %K eHealth, mHealth %K mobile health %K telehealth %K telemedicine %K Internet %K review %D 2015 %7 02.04.2015 %9 Review %J J Med Internet Res %G English %X Background: The high prevalence rate of asthma represents a major societal burden. Advancements in information technology continue to affect the delivery of patient care in all areas of medicine. Internet-based solutions, social media, and mobile technology could address some of the problems associated with increasing asthma prevalence. Objective: This review evaluates Internet-based asthma interventions that were published between 2004 and October 2014 with respect to the use of behavioral change theoretical frameworks, applied clinical guidelines, and assessment tools. Methods: The search term (Asthma AND [Online or Internet or Mobile or Application or eHealth or App]) was applied to six bibliographic databases (Ovid MEDLINE, PubMed, BioMed Central, ProQuest Computing, Web of Knowledge, and ACM Digital Library) including only English-language articles published between 2004 and October 2014. In total, 3932 articles matched the priori search terms and were reviewed by the primary reviewer based on their titles, index terms, and abstracts. The matching articles were then screened by the primary reviewer for inclusion or exclusion based on their abstract, study type, and intervention objectives with respect to the full set of priori inclusion and exclusion criteria; 331 duplicates were identified and removed. A total of 85 articles were included for in-depth review and the remaining 3516 articles were excluded. The primary and secondary reviewer independently reviewed the complete content of the 85 included articles to identify the applied behavioral change theories, clinical guidelines, and assessment tools. Findings and any disagreement between reviewers were resolved by in-depth discussion and through a consolidation process for each of the included articles. Results: The reviewers identified 17 out of 85 interventions (20%) where at least one model, framework, and/or construct of a behavioral change theory were applied. The review identified six clinical guidelines that were applied across 30 of the 85 interventions (35%) as well as a total of 21 assessment tools that were applied across 32 of the 85 interventions (38%). Conclusions: The findings of this literature review indicate that the majority of published Internet-based interventions do not use any documented behavioral change theory, clinical guidelines, and/or assessment tools to inform their design. Further, it was found that the application of clinical guidelines and assessment tools were more salient across the reviewed interventions. A consequence, as such, is that many Internet-based asthma interventions are designed in an ad hoc manner, without the use of any notable evidence-based theoretical frameworks, clinical guidelines, and/or assessment tools. %M 25835564 %R 10.2196/jmir.4110 %U http://www.jmir.org/2015/4/e89/ %U https://doi.org/10.2196/jmir.4110 %U http://www.ncbi.nlm.nih.gov/pubmed/25835564 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 3 %P e85 %T The Potential of Technology-Based Psychological Interventions for Anorexia and Bulimia Nervosa: A Systematic Review and Recommendations for Future Research %A Schlegl,Sandra %A Bürger,Carolina %A Schmidt,Luise %A Herbst,Nirmal %A Voderholzer,Ulrich %+ Department of Psychiatry and Psychotherapy, University of Munich, Nussbaumstraße 7, München, 80336, Germany, 49 89440053369, sandra.schlegl@med.uni-muenchen.de %K anorexia nervosa %K bulimia nervosa %K computers %K Internet %K mobile phone %K cognitive behavioral therapy %D 2015 %7 31.03.2015 %9 Review %J J Med Internet Res %G English %X Background: Previous studies have shown an unmet need in the treatment of eating disorders. In the last decade, interest in technology-based interventions (TBIs) (including computer- and Internet-based interventions [CBIs] or mobile interventions) for providing evidence-based therapies to individuals with different mental disorders has increased. Objective: The aim of this review was to systematically evaluate the potential of TBIs in the field of eating disorders, namely for anorexia nervosa (AN) and bulimia nervosa (BN), for both prevention and treatment, and also for carers of eating disorder patients. Methods: A systematic literature search was conducted using Medline and PsycINFO. Bibliographies of retrieved articles were also reviewed without date or study type restrictions. Results: Forty studies resulting in 45 publications reporting outcomes fulfilled the inclusion criteria: 22 randomized controlled trials, 2 controlled studies, and 16 uncontrolled studies. In total, 3646 patients were included. Overall, the studies provided evidence for the efficacy of guided CBIs, especially for BN patients and for compliant patients. Furthermore, videoconferencing also appeared to be a promising approach. Evaluation results of Internet-based prevention of eating disorders and Internet-based programs for carers of eating disorder patients were also encouraging. Finally, there was preliminary evidence for the efficacy of mobile interventions. Conclusions: TBIs may be an additional way of delivering evidence-based treatments to eating disorder patients and their use is likely to increase in the near future. TBIs may also be considered for the prevention of eating disorders and to support carers of eating disorder patients. Areas of future research and important issues such as guidance, therapeutic alliance, and dissemination are discussed. %M 25840591 %R 10.2196/jmir.3554 %U http://www.jmir.org/2015/3/e85/ %U https://doi.org/10.2196/jmir.3554 %U http://www.ncbi.nlm.nih.gov/pubmed/25840591 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 3 %P e72 %T Efficacy of a Web-Based, Crowdsourced Peer-To-Peer Cognitive Reappraisal Platform for Depression: Randomized Controlled Trial %A Morris,Robert R %A Schueller,Stephen M %A Picard,Rosalind W %+ MIT Media Lab, Massachusetts Institute of Technology, E14-348A, 75 Amherst St, Cambridge, MA, 02139, United States, 1 6172530611, rmorris@media.mit.edu %K Web-based intervention %K crowdsourcing %K randomized controlled trial %K depression %K cognitive behavioral therapy %K mental health %K social networks %D 2015 %7 30.03.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Self-guided, Web-based interventions for depression show promising results but suffer from high attrition and low user engagement. Online peer support networks can be highly engaging, but they show mixed results and lack evidence-based content. Objective: Our aim was to introduce and evaluate a novel Web-based, peer-to-peer cognitive reappraisal platform designed to promote evidence-based techniques, with the hypotheses that (1) repeated use of the platform increases reappraisal and reduces depression and (2) that the social, crowdsourced interactions enhance engagement. Methods: Participants aged 18-35 were recruited online and were randomly assigned to the treatment group, “Panoply” (n=84), or an active control group, online expressive writing (n=82). Both are fully automated Web-based platforms. Participants were asked to use their assigned platform for a minimum of 25 minutes per week for 3 weeks. Both platforms involved posting descriptions of stressful thoughts and situations. Participants on the Panoply platform additionally received crowdsourced reappraisal support immediately after submitting a post (median response time=9 minutes). Panoply participants could also practice reappraising stressful situations submitted by other users. Online questionnaires administered at baseline and 3 weeks assessed depression symptoms, reappraisal, and perseverative thinking. Engagement was assessed through self-report measures, session data, and activity levels. Results: The Panoply platform produced significant improvements from pre to post for depression (P=.001), reappraisal (P<.001), and perseverative thinking (P<.001). The expressive writing platform yielded significant pre to post improvements for depression (P=.02) and perseverative thinking (P<.001), but not reappraisal (P=.45). The two groups did not diverge significantly at post-test on measures of depression or perseverative thinking, though Panoply users had significantly higher reappraisal scores (P=.02) than expressive writing. We also found significant group by treatment interactions. Individuals with elevated depression symptoms showed greater comparative benefit from Panoply for depression (P=.02) and perseverative thinking (P=.008). Individuals with baseline reappraisal deficits showed greater comparative benefit from Panoply for depression (P=.002) and perseverative thinking (P=.002). Changes in reappraisal mediated the effects of Panoply, but not the expressive writing platform, for both outcomes of depression (ab=-1.04, SE 0.58, 95% CI -2.67 to -.12) and perseverative thinking (ab=-1.02, SE 0.61, 95% CI -2.88 to -.20). Dropout rates were similar for the two platforms; however, Panoply yielded significantly more usage activity (P<.001) and significantly greater user experience scores (P<.001). Conclusions: Panoply engaged its users and was especially helpful for depressed individuals and for those who might ordinarily underutilize reappraisal techniques. Further investigation is needed to examine the long-term effects of such a platform and whether the benefits generalize to a more diverse population of users. Trial Registration: ClinicalTrials.gov NCT02302248; https://clinicaltrials.gov/ct2/show/NCT02302248 (Archived by WebCite at http://www.webcitation.org/6Wtkj6CXU). %M 25835472 %R 10.2196/jmir.4167 %U http://www.jmir.org/2015/3/e72/ %U https://doi.org/10.2196/jmir.4167 %U http://www.ncbi.nlm.nih.gov/pubmed/25835472 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 3 %P e77 %T Information and Communication Technology–Enabled Person-Centered Care for the “Big Five” Chronic Conditions: Scoping Review %A Wildevuur,Sabine E %A Simonse,Lianne WL %+ Talma Institute, Social Sciences, VU University Amsterdam, VU Amsterdam/FSW/SOC, De Boelelaan 1081, Amsterdam, 1081 HV, Netherlands, 31 205986888, s.wildevuur@vu.nl %K patient-centered care %K person-centered care %K telemedicine %K chronic disease %K neoplasms %K cardiovascular diseases %K chronic respiratory tract diseases %K diabetes mellitus %K stroke %K disease management %K self-care %K decision making %K eHealth %D 2015 %7 27.03.2015 %9 Review %J J Med Internet Res %G English %X Background: Person-centered information and communication technology (ICT) could encourage patients to take an active part in their health care and decision-making process, and make it possible for patients to interact directly with health care providers and services about their personal health concerns. Yet, little is known about which ICT interventions dedicated to person-centered care (PCC) and connected-care interactions have been studied, especially for shared care management of chronic diseases. The aim of this research is to investigate the extent, range, and nature of these research activities and identify research gaps in the evidence base of health studies regarding the “big 5” chronic diseases: diabetes mellitus, cardiovascular disease, chronic respiratory disease, cancer, and stroke. Objective: The objective of this paper was to review the literature and to scope the field with respect to 2 questions: (1) which ICT interventions have been used to support patients and health care professionals in PCC management of the big 5 chronic diseases? and (2) what is the impact of these interventions, such as on health-related quality of life and cost efficiency? Methods: This research adopted a scoping review method. Three electronic medical databases were accessed: PubMed, EMBASE, and Cochrane Library. The research reviewed studies published between January 1989 and December 2013. In 5 stages of systematic scanning and reviewing, relevant studies were identified, selected, and charted. Then we collated, summarized, and reported the results. Results: From the initial 9380 search results, we identified 350 studies that qualified for inclusion: diabetes mellitus (n=103), cardiovascular disease (n=89), chronic respiratory disease (n=73), cancer (n=67), and stroke (n=18). Persons with one of these chronic conditions used ICT primarily for self-measurement of the body, when interacting with health care providers, with the highest rates of use seen in chronic respiratory (63%, 46/73) and cardiovascular (53%, 47/89) diseases. We found 60 relevant studies (17.1%, 60/350) on person-centered shared management ICT, primarily using telemedicine systems as personalized ICT. The highest impact measured related to the increase in empowerment (15.4%, 54/350). Health-related quality of life accounted for 8%. The highest impact connected to health professionals was an increase in clinical outcome (11.7%, 41/350). The impacts on organization outcomes were decrease in hospitalization (12.3%, 43/350) and increase of cost efficiency (10.9%, 38/350). Conclusions: This scoping review outlined ICT-enabled PCC in chronic disease management. Persons with a chronic disease could benefit from an ICT-enabled PCC approach, but ICT-PCC also yields organizational paybacks. It could lead to an increase in health care usage, as reported in some studies. Few interventions could be regarded as “fully” addressing PCC. This review will be especially helpful to those deciding on areas where further development of research or implementation of ICT-enabled PCC may be warranted. %M 25831199 %R 10.2196/jmir.3687 %U http://www.jmir.org/2015/3/e77/ %U https://doi.org/10.2196/jmir.3687 %U http://www.ncbi.nlm.nih.gov/pubmed/25831199 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 3 %P e82 %T A Web-Based Health Promotion Program for Older Workers: Randomized Controlled Trial %A Cook,Royer F %A Hersch,Rebekah K %A Schlossberg,Dana %A Leaf,Samantha L %+ ISA Associates, 201 North Union Street, Suite 330, Alexandria, VA, 22314, United States, 1 703 739 0880 ext 12, rcook@isagroup.com %K Internet %K health promotion %K middle aged %K nutritional requirements %K exercise %D 2015 %7 25.03.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Recent evidence supports the efficacy of programs that promote improvements in the health practices of workers 50 years and older who are at higher risk for chronic diseases than younger workers are. Internet-based programs that promote healthy practices have also shown promise and, therefore, should be especially appropriate for workers aged 50 years and older. Objective: The purpose of the research was to evaluate the effectiveness of HealthyPast50, a fully automated Web-based health promotion program based on social cognitive theory and aimed specifically at workers 50 years and older. Methods: The randomized controlled trial was conducted across multiple US offices of a large global information technology company. The sample included 278 employees aged 50 to 68 who were recruited online and randomly assigned to the Web-based HealthyPast50 program or to a wait-list control condition. Self-report measures of diet, physical activity, stress, and tobacco use were collected online before and 3 months after the program group was given access to the program. Use data included number of log-ins and number of pages accessed. The primary analysis was multiple linear regression, following intent-to-treat principles with multiple imputation using the Markov chain Monte Carlo (MCMC) approach for nonmonotone missing data. Potential moderators from demographic characteristics and program dosage effects were assessed using multiple linear regression models. Additional analyses were conducted on complete (nonimputed) cases, excluding program participants who used the program for less than 30 minutes. Results: Retention rates were good for both groups: 80.4% (111/138) for the program group and 94.3% (132/140) for the control group. Program group participants spent a mean of 102.26 minutes in the program (SD 148.32), logged in a mean of 4.33 times (SD 4.28), and viewed a mean of 11.04 pages (SD 20.08). In the analysis of the imputed dataset, the program group performed significantly better than the control group on diet behavioral change self-efficacy (estimated adjusted difference [Δ]=0.16, P=.048), planning healthy eating (Δ=0.17, P=.03), and mild exercise (Δ=1.03, P=.01). Moderator and dosage analyses of the dataset found no significant program effects. Analyses of the nonimputed dataset comparing program users with controls found additional significant program effects on eating practices (Δ=0.09, P=.03), exercise self-efficacy (Δ=0.12, P=.03), exercise planning (Δ=0.18, P=.03), and aging beliefs (Δ=0.17, P=.01). Moderator analysis of this dataset also found significant moderator effects of gender on multiple measures of exercise. Conclusions: A Web-based health promotion program showed promise for making a significant contribution to the short-term dietary and exercise practices of older working adults. Gender effects suggest that the program effects on exercise are due mainly to improvements among women. %M 25830503 %R 10.2196/jmir.3399 %U http://www.jmir.org/2015/3/e82/ %U https://doi.org/10.2196/jmir.3399 %U http://www.ncbi.nlm.nih.gov/pubmed/25830503 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 1 %P e35 %T Working With Parents to Prevent Childhood Obesity: Protocol for a Primary Care-Based eHealth Study %A Avis,Jillian LS %A Cave,Andrew L %A Donaldson,Stephanie %A Ellendt,Carol %A Holt,Nicholas L %A Jelinski,Susan %A Martz,Patricia %A Maximova,Katerina %A Padwal,Raj %A Wild,T Cameron %A Ball,Geoff DC %+ Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, 11405 - 87 Avenue NW, Edmonton, AB, T6G1C9, Canada, 1 780 492 8727, gdball@ualberta.ca %K body weight %K Canada %K child %K childhood obesity %K Internet %K parents %K prevention %K primary health care %D 2015 %7 25.03.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Parents play a central role in preventing childhood obesity. There is a need for innovative, scalable, and evidence-based interventions designed to enhance parents’ motivation to support and sustain healthy lifestyle behaviors in their children, which can facilitate obesity prevention. Objective: (1) Develop an online screening, brief intervention, and referral to treatment (SBIRT) eHealth tool to enhance parents’ concern for, and motivation to, support children’s healthy lifestyle behaviors, (2) refine the SBIRT eHealth tool by assessing end-user acceptability, satisfaction, and usability through focus groups, and (3) determine feasibility and preliminary effectiveness of the refined SBIRT eHealth tool through a randomized controlled trial. Methods: This is a three-phase, multi-method study that includes SBIRT eHealth tool development (Phase I), refinement (Phase II), and testing (Phase III). Phase I: Theoretical underpinnings of the SBIRT tool, entitled the Resource Information Program for Parents on Lifestyle and Education (RIPPLE), will be informed by concepts applied within existing interventions, and content will be based on literature regarding healthy lifestyle behaviors in children. The SBIRT platform will be developed in partnership between our research team and a third-party intervention development company. Phase II: Focus groups with parents, as well as health care professionals, researchers, and trainees in pediatrics (n=30), will explore intervention-related perceptions and preferences. Qualitative data from the focus groups will inform refinements to the aesthetics, content, structure, and function of the SBIRT. Phase III: Parents (n=200) of children—boys and girls, 5 to 17 years old—will be recruited from a primary care pediatric clinic while they await their children’s clinical appointment. Parents will be randomly assigned to one of five groups—four intervention groups and one control group—as they complete the SBIRT. The randomization function is built into the tool. Parents will complete the eHealth SBIRT using a tablet that will be connected to the Internet. Subsequently, parents will be contacted via email at 1-month follow-up to assess (1) change in concern for, and motivation to, support children’s dietary and physical activity behaviors (primary outcome), and (2) use of online resources and referrals to health services for obesity prevention (secondary outcome). Results: This research was successfully funded and received ethics approval. Development of the SBIRT started in summer 2012, and we expect all study-related activities to be completed by fall 2016. Conclusions: The proposed research is timely and applies a novel, technology-based application designed to enhance parents concern for, and motivation to, support children’s healthy lifestyle behaviors and encourage use of online resources and community services for childhood obesity prevention. Overall, this research builds on a foundation of evidence supporting the application of SBIRTs to encourage or “nudge” individuals to make healthy lifestyle choices. Findings from Phase III of this project will directly inform a cluster randomized controlled trial to study the effectiveness of our intervention across multiple primary care-based settings. Trial Registration: ClinicalTrials.gov NCT02330588; http://clinicaltrials.gov/ct2/show/NCT02330588 (Archived by WebCite at http://www.webcitation.org/6WyUOeRlr). %M 25831265 %R 10.2196/resprot.4147 %U http://www.researchprotocols.org/2015/1/e35/ %U https://doi.org/10.2196/resprot.4147 %U http://www.ncbi.nlm.nih.gov/pubmed/25831265 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 3 %P e71 %T Web-Based Psychotherapy for Posttraumatic Stress Disorder in War-Traumatized Arab Patients: Randomized Controlled Trial %A Knaevelsrud,Christine %A Brand,Janine %A Lange,Alfred %A Ruwaard,Jeroen %A Wagner,Birgit %+ Department of Clinical Psychology, Freie University, Habelschwerdter Allee 45, Berlin, 14195, Germany, 49 30 838557, christine.knaevelsrud@fu-berlin.de %K posttraumatic stress disorders %K Middle East %K war %K violence %K cognitive therapy %K mental health service %K Internet %D 2015 %7 20.03.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: In recent years, armed conflicts in the Middle East have resulted in high rates of exposure to traumatic events. Despite the increasing demand of mental health care provision, ongoing violence limits conventional approaches of mental health care provision. Internet-based interventions for posttraumatic stress disorder (PTSD) have proved feasible and effective in Western countries, but their applicability and efficacy in war and conflict regions remains unknown. Objective: This study investigated the efficacy of a cognitive behavioral Internet-based intervention for war-traumatized Arab patients, with focus on Iraq. Methods: A total of 159 individuals with PTSD participated in a parallel group randomized trial. Participants were randomly allocated by a computer-generated sequence to a treatment group (n=79) or a waiting list control group (n=80). The treatment group received 2 weekly 45-minute cognitive behavioral interventions via Internet over a 5-week period (10 sessions in total). The primary outcome was recovery from posttraumatic stress symptoms. Results: Posttraumatic stress symptoms were significantly reduced from baseline to posttreatment (intention-to-treat analysis) in the treatment group relative to the control group (F1,157=44.29, P<.001, d=0.92). Treatment effects were sustained at 3-month follow-up. Completer analysis indicated that 29 of 47 patients (62%) in the treatment group had recovered from posttraumatic stress symptoms at posttreatment (reliable change and Posttraumatic Stress Diagnostic Scale score <20) versus 1 patient (2%) in the control group (OR 74.19, 95% CI 9.93-585.8, P<.001) indicating that the chance of recovering was 74.19 times higher in the treatment than in the control group. Conclusions: The results indicate, even in unstable and insecure settings with ongoing exposure to human rights violations through war and dictatorships, people with posttraumatic stress symptoms benefit from a cognitive behavioral treatment provided entirely through the Internet. This method of delivery could improve patients’ access to humanitarian aid in the form of e-mental health services. Trial Registration: Australian New Zealand Clinical Trial Registry, ACTRN12611001019998; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=347505 (Archived by WebCite at http://www.webcitation.org/6Wto4HCdH). %M 25799024 %R 10.2196/jmir.3582 %U http://www.jmir.org/2015/3/e71/ %U https://doi.org/10.2196/jmir.3582 %U http://www.ncbi.nlm.nih.gov/pubmed/25799024 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 3 %P e65 %T The Effect of Technology-Based Interventions on Pain, Depression, and Quality of Life in Patients With Cancer: A Systematic Review of Randomized Controlled Trials %A Agboola,Stephen O %A Ju,Woong %A Elfiky,Aymen %A Kvedar,Joseph C %A Jethwani,Kamal %+ Partners Healthcare Center for Connected Health, 25 New Chardon St., Suite 300, Boston, MA, 02114, United States, 1 617 643 0291, sagboola@partners.org %K telehealth %K connected health %K cancer %K telephone %K pain %K depression %K quality of life %K systematic review %K randomized controlled trials %D 2015 %7 13.03.2015 %9 Review %J J Med Internet Res %G English %X Background: The burden of cancer is increasing; projections over the next 2 decades suggest that the annual cases of cancer will rise from 14 million in 2012 to 22 million. However, cancer patients in the 21st century are living longer due to the availability of novel therapeutic regimens, which has prompted a growing focus on maintaining patients’ health-related quality of life. Telehealth is increasingly being used to connect with patients outside of traditional clinical settings, and early work has shown its importance in improving quality of life and other clinical outcomes in cancer care. Objective: The aim of this study was to systematically assess the literature for the effect of supportive telehealth interventions on pain, depression, and quality of life in cancer patients via a systematic review of clinical trials. Methods: We searched PubMed, EMBASE, Google Scholar, CINAHL, and PsycINFO in July 2013 and updated the literature search again in January 2015 for prospective randomized trials evaluating the effect of telehealth interventions in cancer care with pain, depression, and quality of life as main outcomes. Two of the authors independently reviewed and extracted data from eligible randomized controlled trials, based on pre-determined selection criteria. Methodological quality of studies was assessed by the Cochrane Collaboration risk of bias tool. Results: Of the 4929 articles retrieved from databases and relevant bibliographies, a total of 20 RCTs were included in the final review. The studies were largely heterogeneous in the type and duration of the intervention as well as in outcome assessments. A majority of the studies were telephone-based interventions that remotely connected patients with their health care provider or health coach. The intervention times ranged from 1 week to 12 months. In general, most of the studies had low risk of bias across the domains of the Cochrane Collaboration risk of bias tool, but most of the studies had insufficient information about the allocation concealment domain. Two of the three studies focused on pain control reported significant effects of the intervention; four of the nine studies focus on depression reported significant effects, while only the studies that were focused on quality of life reported significant effects. Conclusions: This systematic review demonstrates the potential of telehealth interventions in improving outcomes in cancer care. However, more high-quality large-sized trials are needed to demonstrate cogent evidence of its effectiveness. %M 25793945 %R 10.2196/jmir.4009 %U http://www.jmir.org/2015/3/e65/ %U https://doi.org/10.2196/jmir.4009 %U http://www.ncbi.nlm.nih.gov/pubmed/25793945 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 3 %P e67 %T Expectations Among Patients and Health Professionals Regarding Web-Based Interventions for Depression in Primary Care: A Qualitative Study %A Montero-Marín,Jesús %A Prado-Abril,Javier %A Botella,Cristina %A Mayoral-Cleries,Fermin %A Baños,Rosa %A Herrera-Mercadal,Paola %A Romero-Sanchiz,Pablo %A Gili,Margalida %A Castro,Adoración %A Nogueira,Raquel %A García-Campayo,Javier %+ Psychiatry Service, Miguel Servet University Hospital, Avda Isabel La Católica 1, Zaragoza, 50009, Spain, 34 976253621, jgarcamp@gmail.com %K depression %K computer-delivered psychotherapy %K qualitative methods %K expectations %D 2015 %7 10.03.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: One-quarter of the world’s population will suffer from depression symptoms at some point in their lives. Mental health services in developed countries are overburdened. Therefore, cost-effective interventions that provide mental health care solutions such as Web-based psychotherapy programs have been proposed. Objective: The intent of the study was to identify expectations regarding Web-based psychotherapy for the treatment of depression in primary care among patients and health professionals that might facilitate or hinder its effects. Methods: The expectations of untreated patients and health professionals were examined by means of interviews and focus groups. There were 43 participants (20 patients with mild and moderate levels of depression, 11 primary care physicians, and 12 managers; 22 of them for interviews and 21 for groups). A thematic content analysis from the grounded theory for interviews, and an analysis of the discursive positions of participants based on the sociological model for groups were performed. Interpretations were achieved by agreement between three independent analysts. Results: All participants showed a good general acceptance of Web-based psychotherapy, appreciating possible advantages and improvements. Patients, physicians, and managers shared the same conceptualization of their expectations, although highlighting different aspects. Patients focused on the need for individualized and personalized interaction, while professionals highlighted the need for the standardization of the program. Physicians were concerned with extra workload, while managers were worried about optimizing cost-effectiveness. Conclusions: Expectations of the different participants can conflict with each other. Finding a balanced position among them is needed if we are to harmoniously implement effective Web-based interventions for depression in routine clinical practice. %M 25757358 %R 10.2196/jmir.3985 %U http://www.jmir.org/2015/3/e67/ %U https://doi.org/10.2196/jmir.3985 %U http://www.ncbi.nlm.nih.gov/pubmed/25757358 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 3 %P e59 %T A Web-Based, Computer-Tailored Smoking Prevention Program to Prevent Children From Starting to Smoke After Transferring to Secondary School: Randomized Controlled Trial %A Cremers,Henricus-Paul %A Mercken,Liesbeth %A Candel,Math %A de Vries,Hein %A Oenema,Anke %+ Maastricht University, Department of Health Promotion, School for Public Health and Primary Care (CAPHRI), PO Box 616, Maastricht, 6200 MD Maastricht, Netherlands, 31 (0)43 388 2379, p.cremers@maastrichtuniversity.nl %K Web-based intervention %K primary school children %K smoking prevention %K prompts %K computer-tailoring %D 2015 %7 09.03.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Smoking prevalence rates among Dutch children increase rapidly after they transit to secondary school, in particular among children with a low socioeconomic status (SES). Web-based, computer-tailored programs supplemented with prompt messages may be able to empower children to prevent them from starting to smoke when they transit to secondary school. Objective: The main aim of this study is to evaluate whether computer-tailored feedback messages, with and without prompt messages, are effective in decreasing children’s smoking intentions and smoking behavior after 12 and 25 months of follow-up. Methods: Data were gathered at baseline (T0), and after 12 months (T1) and 25 months (T2) of follow-up of a smoking prevention intervention program called Fun without Smokes. A total of 162 schools were randomly allocated to a no-intervention control group, an intervention prompt group, or an intervention no-prompt group. A total of 3213 children aged 10 to 12 years old participated in the study and completed a Web-based questionnaire assessing their smoking intention, smoking behavior, and sociocognitive factors, such as attitude, social influence, and self-efficacy, related to smoking. After completion, children in the intervention groups received computer-tailored feedback messages in their own email inbox and those messages could be accessed on the intervention website. Children in the prompt group received prompt messages, via email and short message service (SMS) text messaging, to stimulate them to reuse the intervention website with nonsmoking content. Multilevel logistic regression analyses were performed using multiple imputations to assess the program effects on smoking intention and smoking behavior at T1 and T2. Results: A total of 3213 children participated in the Fun without Smokes study at T0. Between T0 and T1 a total of 1067 children out of the original 3213 (33.21%) dropped out of the study. Between T0 and T2 the number of children that did not participate in the final measurement was 1730 out of the original 3213 (53.84%). No significant program effects were observed for any of the intervention groups compared to the control group at T1 for the intention to engage in smoking—prompt, OR 0.67 (95% CI 0.30-1.50), no-prompt, OR 0.76 (95% CI 0.34-1.67)—or for smoking behavior—prompt, OR 1.13 (95% CI 0.13-9.98), no-prompt, OR 0.50 (95% CI 0.04-5.59). Similar nonsignificant program effects were found at T2 for the intention to start smoking—prompt, OR 0.78 (95% CI 0.26-2.32), no-prompt, OR 1.31 (95% CI 0.45-3.82)—and smoking behavior—prompt, OR 0.53 (95% CI 0.12-2.47), no-prompt, OR 1.01 (95% CI 0.24-4.21). Conclusions: This study showed that the Web-based, computer-tailored feedback messages with and without prompt messages were not effective in modifying children’s smoking intentions and smoking behavior as compared to no information. Future smoking prevention interventions are recommended to start closer to the age of actual smoking uptake. Furthermore, future studies on Web-based, computer-tailored smoking prevention programs should focus on assessing and controlling exposure to the educational content and the response to the prompt messages. Trial Registration: Netherlands Trial Register NTR3116; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3116 (Archived by WebCite at http://www.webcitation.org/6O0wQYuPI). %M 25759248 %R 10.2196/jmir.3794 %U http://www.jmir.org/2015/3/e59/ %U https://doi.org/10.2196/jmir.3794 %U http://www.ncbi.nlm.nih.gov/pubmed/25759248 %0 Journal Article %@ 2368-7959 %I JMIR Publications Inc. %V 2 %N 1 %P e3 %T Breaking Open the Black Box: Isolating the Most Potent Features of a Web and Mobile Phone-Based Intervention for Depression, Anxiety, and Stress %A Whitton,Alexis E %A Proudfoot,Judith %A Clarke,Janine %A Birch,Mary-Rose %A Parker,Gordon %A Manicavasagar,Vijaya %A Hadzi-Pavlovic,Dusan %+ The Black Dog Institute, University of New South Wales, Hospital Road, Prince of Wales Hospital, Sydney, 2031, Australia, 61 2 9382 3767, alexis.e.whitton@gmail.com %K eHealth %K depression %K anxiety %K stress %K psychological stress %K self-help %K Web-based %K mental health %D 2015 %7 04.03.2015 %9 Original Paper %J JMIR Mental Health %G English %X Background: Internet-delivered mental health (eMental Health) interventions produce treatment effects similar to those observed in face-to-face treatment. However, there is a large degree of variation in treatment effects observed from program to program, and eMental Health interventions remain somewhat of a black box in terms of the mechanisms by which they exert their therapeutic benefit. Trials of eMental Health interventions typically use large sample sizes and therefore provide an ideal context within which to systematically investigate the therapeutic benefit of specific program features. Furthermore, the growth and impact of mobile phone technology within eMental Health interventions provides an opportunity to examine associations between symptom improvement and the use of program features delivered across computer and mobile phone platforms. Objective: The objective of this study was to identify the patterns of program usage associated with treatment outcome in a randomized controlled trial (RCT) of a fully automated, mobile phone- and Web-based self-help program, “myCompass”, for individuals with mild-to-moderate symptoms of depression, anxiety, and/or stress. The core features of the program include interactive psychotherapy modules, a symptom tracking feature, short motivational messages, symptom tracking reminders, and a diary, with many of these features accessible via both computer and mobile phone. Methods: Patterns of program usage were recorded for 231 participants with mild-to-moderate depression, anxiety, and/or stress, and who were randomly allocated to receive access to myCompass for seven weeks during the RCT. Depression, anxiety, stress, and functional impairment were examined at baseline and at eight weeks. Results: Log data indicated that the most commonly used components were the short motivational messages (used by 68.4%, 158/231 of participants) and the symptom tracking feature (used by 61.5%, 142/231 of participants). Further, after controlling for baseline symptom severity, increased use of these alert features was associated with significant improvements in anxiety and functional impairment. Associations between use of symptom tracking reminders and improved treatment outcome remained significant after controlling for frequency of symptom tracking. Although correlations were not statistically significant, reminders received via SMS (ie, text message) were more strongly associated with symptom reduction than were reminders received via email. Conclusions: These findings indicate that alerts may be an especially potent component of eMental Health interventions, both via their association with enhanced program usage, as well as independently. Although there was evidence of a stronger association between symptom improvement and use of alerts via the mobile phone platform, the degree of overlap between use of email and SMS alerts may have precluded identification of alert delivery modalities that were most strongly associated with symptom reduction. Future research using random assignment to computer and mobile delivery is needed to fully determine the most ideal platform for delivery of this and other features of online interventions. Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN): 12610000625077; http://www.anzctr.org.au/TrialSearch.aspx? (Archived by WebCite http://www.webcitation.org/6WPqHK0mQ). %M 26543909 %R 10.2196/mental.3573 %U http://mental.jmir.org/2015/1/e3/ %U https://doi.org/10.2196/mental.3573 %U http://www.ncbi.nlm.nih.gov/pubmed/26543909 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 3 %P e53 %T Effectiveness of a Web-Based Tailored Interactive Health Communication Application for Patients With Type 2 Diabetes or Chronic Low Back Pain: Randomized Controlled Trial %A Weymann,Nina %A Dirmaier,Jörg %A von Wolff,Alessa %A Kriston,Levente %A Härter,Martin %+ Department of Medical Psychology, Center for Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Martinistr. 52, Hamburg, 20246, Germany, 49 40 7410 59137, dirmaier@uke.de %K Type 2 diabetes mellitus %K back pain %K randomized controlled trial %K health communication %K Internet %D 2015 %7 03.03.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: The prevalence of chronic diseases such as type 2 diabetes and chronic low back pain is rising. Patient empowerment is a key strategy in the management of chronic diseases. Patient empowerment can be fostered by Web-based interactive health communication applications (IHCAs) that combine health information with decision support, social support, and/or behavioral change support. Tailoring the content and tone of IHCAs to the needs of individual patients might improve their effectiveness. Objective: The main objective was to test the effectiveness of a Web-based, tailored, fully automated IHCA for patients with type 2 diabetes or chronic low back pain against a standard website with identical content without tailoring (control condition) on patients’ knowledge and empowerment. Methods: We performed a blinded randomized trial with a parallel design. In the intervention group, the content was delivered in dialogue form, tailored to relevant patient characteristics. In the control group, the sections of the text were presented in a content tree without any tailoring. Participants were recruited online and offline and were blinded to their group assignments. Measurements were taken at baseline (t0), directly after the first visit (t1), and at 3-month follow-up (t2). The primary hypothesis was that the tailored IHCA would have larger effects on knowledge and patient empowerment (primary outcomes) than the control website. The secondary outcomes were decisional conflict and preparation for decision making. All measurements were conducted by online self-report questionnaires. Intention-to-treat (ITT) and available cases (AC) analyses were performed for all outcomes. Results: A total of 561 users agreed to participate in the study. Of these, 179 (31.9%) had type 2 diabetes and 382 (68.1%) had chronic low back pain. Usage was significantly higher in the tailored system (mean 51.2 minutes) than in the control system (mean 37.6 minutes; P<.001). Three months after system use, 52.4% of the sample was retained. There was no significant intervention effect in the ITT analysis. In the AC analysis, participants using the tailored system displayed significantly more knowledge at t1 (P=.02) and more emotional well-being (subscale of empowerment) at t2 (P=.009). The estimated mean difference between the groups was 3.9 (95% CI 0.5-7.3) points for knowledge and 25.4 (95% CI 6.3-44.5) points for emotional well-being on a 0-100 points scale. Conclusions: The primary analysis did not support the study hypothesis. However, content tailoring and interactivity may increase knowledge and reduce health-related negative effects in persons who use IHCAs. There were no main effects of the intervention on other dimensions of patient empowerment or decision-related outcomes. This might be due to our tailored IHCA being, at its core, an educational intervention offering health information in a personalized, empathic fashion that merely additionally provides decision support. Tailoring and interactivity may not make a difference with regard to these outcomes. Trial Registration: International Clinical Trials Registry: DRKS00003322; http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00003322 (Archived by WebCite at http://www.webcitation.org/6WPO0lJwE). %M 25736340 %R 10.2196/jmir.3904 %U http://www.jmir.org/2015/3/e53/ %U https://doi.org/10.2196/jmir.3904 %U http://www.ncbi.nlm.nih.gov/pubmed/25736340 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 3 %P e56 %T The Impact of a Web-Based App (eBalance) in Promoting Healthy Lifestyles: Randomized Controlled Trial %A Safran Naimark,Jenny %A Madar,Zecharia %A R Shahar,Danit %+ Robert H. Smith Faculty of Agriculture, Food and Environment, Hebrew University of Jerusalem, POBox 12, Rehovot, 76100, Israel, 972 524788559, jennynaimark@gmail.com %K Web-based %K healthy lifestyle %K mobile apps %K mhealth %D 2015 %7 02.03.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: The use of Web-based apps to promote a healthy lifestyle is increasing, although most of these programs were not assessed using suitable epidemiological methods. We evaluated the effectiveness of a newly developed Web-based app in promoting a healthy lifestyle and educating adults on such lifestyles. We also analyzed predictors for success in acquiring and maintaining a healthy lifestyle. Objective: Our aim was to compare people receiving a new Web-based app with people who got an introductory lecture alone on healthy lifestyle, weight change, nutritional knowledge, and physical activity, and to identify predictors of success for maintaining a healthy lifestyle. Methods: Subjects were recruited from the community and were randomized into intervention and control groups. The intervention subjects received access to the app without any face-to-face support; the control subjects continued their standard lifestyle. Measurements were taken by the researcher at baseline and after 14 weeks and included weight and waist circumference. Nutritional knowledge, diet quality, and physical activity duration were obtained using online questionnaires. The new Web-based app was developed based on current US Department of Agriculture and Israel Ministry of Health recommendations for healthy lifestyle. The app provides tools for monitoring diet and physical activity while instructing and encouraging healthy diet and physical activity. Results: Out of 99 subjects who were randomized into app and control groups, 85 participants (86%) completed the study, 56 in the intervention and 29 in the control group. The mean age was 47.9 (SD 12.3) years, and mean Body Mass Index was 26.2 (SD 3.9). Among the intervention group only, frequency of app use was 2.7 (SD 1.9) days/week. The mean change in physical activity was 63 (SD 20.8) minutes in the app group and -30 (SD 27.5) minutes in the control group (P=.02). The mean weight change was -1.44 (SD 0.4) kg in the app group and -0.128 (SD 0.36) kg in the control group (P=.03). Knowledge score increased significantly in the app group, 76 (SD 7.5) to 79 (SD 8.7) at the end of the study (P=.04) compared with the control group. Diet quality score also increased significantly at the end of the study, from 67 (SD 9.8) to 71 (SD 7.6; P<.001) in contrast to the control group. Success score (represents the success in maintaining healthy lifestyle) was higher among the app group (68%) compared with 36% in the control group (P<.001). The app frequency of use was significantly related to a higher success score (P<.001). Conclusions: We showed a positive impact of a newly developed Web-based app on lifestyle indicators during an intervention of 14 weeks. These results are promising in the app’s potential to promote a healthy lifestyle, although larger and longer duration studies are needed to achieve more definitive conclusions. Trial Registration: Clinicaltrial.gov number: NCT01913496; http://www.clinicaltrials.gov/ct2/show/NCT01913496 (Archived by WebCite at http://www.webcitation.org/6WSTUEPuJ). %M 25732936 %R 10.2196/jmir.3682 %U http://www.jmir.org/2015/3/e56/ %U https://doi.org/10.2196/jmir.3682 %U http://www.ncbi.nlm.nih.gov/pubmed/25732936 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 2 %P e50 %T Development of a Twitter-Based Intervention for Smoking Cessation that Encourages High-Quality Social Media Interactions via Automessages %A Pechmann,Cornelia %A Pan,Li %A Delucchi,Kevin %A Lakon,Cynthia M %A Prochaska,Judith J %+ University of California Irvine, The Paul Merage School of Business, Building 2, Room 331, Irvine, CA, 90266, United States, 1 949 824 4058, cpechman@uci.edu %K smoking cessation %K social media %K text messaging %D 2015 %7 23.02.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: The medical field seeks to use social media to deliver health interventions, for example, to provide low-cost, self-directed, online self-help groups. However, engagement in online groups is often low and the informational content may be poor. Objective: The specific study aims were to explore if sending automessages to online self-help groups encouraged engagement and to see if overall or specific types of engagement related to abstinence. Methods: We conducted a Stage I Early Therapy Development Trial of a novel social media intervention for smoking cessation called Tweet2Quit that was delivered online over closed, 20-person quit-smoking groups on Twitter in 100 days. Social media such as Twitter traditionally involves non-directed peer-to-peer exchanges, but our hybrid social media intervention sought to increase and direct such exchanges by sending out two types of autocommunications daily: (1) an “automessage” that encouraged group discussion on an evidence-based cessation-related or community-building topic, and (2) individualized “autofeedback” to each participant on their past 24-hour tweeting. The intervention was purposefully designed without an expert group facilitator and with full automation to ensure low cost, easy implementation, and broad scalability. This purely Web-based trial examined two online quit-smoking groups with 20 members each. Participants were adult smokers who were interested in quitting and were recruited using Google AdWords. Participants’ tweets were counted and content coded, distinguishing between responses to the intervention’s automessages and spontaneous tweets. In addition, smoking abstinence was assessed at 7 days, 30 days, and 60 days post quit date. Statistical models assessed how tweeting related to abstinence. Results: Combining the two groups, 78% (31/40) of the members sent at least one tweet; and on average, each member sent 72 tweets during the 100-day period. The automessage-suggested discussion topics and participants’ responses to those daily automessages were related in terms of their content (r=.75, P=.012). Responses to automessages contributed 22.78% (653/2867) of the total tweets; 77.22% (2214/2867) were spontaneous. Overall tweeting related only marginally to abstinence (OR 1.03, P=.086). However, specific tweet content related to abstinence including tweets about setting of a quit date or use of nicotine patches (OR 1.52, P=.024), countering of roadblocks to quitting (OR 1.76, P=.008) and expressions of confidence about quitting (OR 1.71, SE 0.42, P=.032). Questionable, that is, non-evidence-based, information about quitting did not relate to abstinence (OR 1.12, P=.278). Conclusions: A hybrid social media intervention that combines traditional online social support with daily automessages appears to hold promise for smoking cessation. This hybrid approach capitalizes on social media’s spontaneous real-time peer-to-peer exchanges but supplements this with daily automessages that group members respond to, bolstering and sustaining the social network and directing the information content. Highly engaging, this approach should be studied further. Trial Registration: Clinicaltrials.gov NCT01602536; https://clinicaltrials.gov/ct2/show/NCT01602536 (Archived by WebCite at http://www.webcitation.org/6WGbt0o1K) %M 25707037 %R 10.2196/jmir.3772 %U http://www.jmir.org/2015/2/e50/ %U https://doi.org/10.2196/jmir.3772 %U http://www.ncbi.nlm.nih.gov/pubmed/25707037 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 2 %P e39 %T A Web-Based Program to Increase Knowledge and Reduce Cigarette and Nargila Smoking Among Arab University Students in Israel: Mixed-Methods Study to Test Acceptability %A Essa-Hadad,Jumanah %A Linn,Shai %A Rafaeli,Sheizaf %+ Bar Ilan University, Faculty of Medicine in the Galilee, Henrietta Szold, 8, POB 1589, Safed, 1311502, Israel, 972 502700022, jamanh.essa-hadad@mail.biu.ac.il %K Web-based intervention %K smoking cessation %K nargila smoking %K Arabs in Israel %K university students %K tailored feedback %D 2015 %7 20.02.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Among Arab citizens in Israel, cigarette and nargila (hookah, waterpipe) smoking is a serious public health problem, particularly among the young adult population. With the dramatic increase of Internet and computer use among Arab college and university students, a Web-based program may provide an easy, accessible tool to reduce smoking rates without heavy resource demands required by traditional methods. Objective: The purpose of this research was to examine the acceptability and feasibility of a pilot Web-based program that provides tailored feedback to increase smoking knowledge and reduce cigarette and nargila smoking behaviors among Arab college/university students in Israel. Methods: A pilot Web-based program was developed, consisting of a self-administered questionnaire and feedback system on cigarette and nargila smoking. Arab university students were recruited to participate in a mixed-methods study, using both quantitative (pre-/posttest study design) and qualitative tools. A posttest was implemented at 1 month following participation in the intervention to assess any changes in smoking knowledge and behaviors. Focus group sessions were implemented to assess acceptability and preferences related to the Web-based program. Results: A total of 225 participants—response rate of 63.2% (225/356)—completed the intervention at baseline and at 1-month poststudy, and were used for the comparative analysis. Statistically significant reductions in nargila smoking among participants (P=.001) were found. The intervention did not result in reductions in cigarette smoking. However, the tailored Web intervention resulted in statistically significant increases in the intention to quit smoking (P=.021). No statistically significant increases in knowledge were seen at 1-month poststudy. Participants expressed high satisfaction with the intervention and 93.8% (211/225) of those who completed the intervention at both time intervals reported that they would recommend the program to their friends, indicating excellent acceptability and feasibility of the intervention. This was further emphasized in the focus group sessions. Conclusions: A tailored Web-based program may be a promising tool to reduce nargila smoking among Arab university students in Israel. The tailored Web intervention was not successful at significantly reducing cigarette smoking or increasing knowledge. However, the intervention did increase participants’ intention to quit smoking. Participants considered the Web-based tool to be an interesting, feasible, and highly acceptable strategy. Trial Registration: Trial Registration: ISRCTN registry ISRCTN59207794; http://www.isrctn.com/ISRCTN59207794 (Archived by WebCite at http://www.webcitation.org/6VkYOBNOJ). %M 25707034 %R 10.2196/jmir.2988 %U http://www.jmir.org/2015/2/e39/ %U https://doi.org/10.2196/jmir.2988 %U http://www.ncbi.nlm.nih.gov/pubmed/25707034 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 2 %P e36 %T Utilization of a Web-Based vs Integrated Phone/Web Cessation Program Among 140,000 Tobacco Users: An Evaluation Across 10 Free State Quitlines %A Nash,Chelsea M %A Vickerman,Katrina A %A Kellogg,Elizabeth S %A Zbikowski,Susan M %+ Alere Wellbeing, Research, Training and Evaluation Services, 999 Third Avenue, Suite 2000, Seattle, WA, 98104, United States, 1 206 876 2328, chelsea.nash@alere.com %K Internet-based intervention %K tobacco cessation %K smoking cessation %K Internet %K telephone %K behavior %K evaluation studies %K online support %D 2015 %7 04.02.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Phone-based tobacco cessation program effectiveness has been established and randomized controlled trials have provided some support for Web-based services. Relatively little is known about who selects different treatment modalities and how they engage with treatments in a real-world setting. Objective: This paper describes the characteristics, Web utilization patterns, and return rates of tobacco users who self-selected into a Web-based (Web-Only) versus integrated phone/Web (Phone/Web) cessation program. Methods: We examined the demographics, baseline tobacco use, Web utilization patterns, and return rates of 141,429 adult tobacco users who self-selected into a Web-Only or integrated Phone/Web cessation program through 1 of 10 state quitlines from August 2012 through July 2013. For each state, registrants were only included from the timeframe in which both programs were offered to all enrollees. Utilization data were limited to site interactions occurring within 6 months after registration. Results: Most participants selected the Phone/Web program (113,019/141,429, 79.91%). After enrollment in Web services, Web-Only were more likely to log in compared to Phone/Web (21,832/28,410, 76.85% vs 23,920/56,892, 42.04%; P<.001), but less likely to return after their initial log-in (8766/21,832, 40.15% vs 13,966/23,920, 58.39%; P<.001). In bivariate and multivariable analyses, those who chose Web-Only were younger, healthier, more highly educated, more likely to be uninsured or commercially insured, more likely to be white non-Hispanic and less likely to be black non-Hispanic, less likely to be highly nicotine-addicted, and more likely to have started their program enrollment online (all P<.001). Among both program populations, participants were more likely to return to Web services if they were women, older, more highly educated, or were sent nicotine replacement therapy (NRT) through their quitline (all P<.001). Phone/Web were also more likely to return if they had completed a coaching call, identified as white non-Hispanic or “other” race, or were commercially insured (all P<.001). Web-Only were less likely to return if they started their enrollment online versus via phone. The interactive Tobacco Tracker, Cost Savings Calculator, and Quitting Plan were the most widely used features overall. Web-Only were more likely than Phone/Web to use most key features (all P<.001), most notably the 5 Quitting Plan behaviors. Among quitlines that offered NRT to both Phone/Web and Web-Only, Web-Only were less likely to have received quitline NRT. Conclusions: This paper adds to our understanding of who selects different cessation treatment modalities and how they engage with the program in a real-world setting. Web-Only were younger, healthier smokers of higher socioeconomic status who interacted more intensely with services in a single session, but were less likely to re-engage or access NRT benefits. Further research should examine the efficacy of different engagement techniques and services with different subpopulations of tobacco users. %M 25673013 %R 10.2196/jmir.3658 %U http://www.jmir.org/2015/2/e36/ %U https://doi.org/10.2196/jmir.3658 %U http://www.ncbi.nlm.nih.gov/pubmed/25673013 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 1 %P e22 %T Development of a Web-Based and Mobile App to Support Physical Activity in Individuals With Rheumatoid Arthritis: Results From the Second Step of a Co-Design Process %A Revenäs,Åsa %A Opava,Christina H %A Martin,Cathrin %A Demmelmaier,Ingrid %A Keller,Christina %A Åsenlöf,Pernilla %+ Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Zanderska huset, Alfred Nobels Allé 23 /23100, Huddinge, 141 83, Sweden, 46 722 304853, asa.revenas@ki.se %K eHealth %K Internet intervention %K physical activity %K rheumatoid arthritis %K behavior change techniques %K participatory design %D 2015 %7 09.02.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Long-term adherence to physical activity recommendations remains challenging for most individuals with rheumatoid arthritis (RA) despite evidence for its health benefits. Objective: The aim of this study was to provide basic data on system requirement specifications for a Web-based and mobile app to self-manage physical activity. More specifically, we explored the target user group, features of the future app, and correlations between the system requirements and the established behavior change techniques (BCTs). Methods: We used a participatory action research design. Qualitative data were collected using multiple methods in four workshops. Participants were 5 individuals with RA, a clinical physiotherapist, an officer from the Swedish Rheumatism Association, a Web designer, and 2 physiotherapy researchers. A taxonomy was used to determine the degree of correlation between the system requirements and established BCTs. Results: Participants agreed that the future Web-based and mobile app should be based on two major components important for maintaining physical activity: (1) a calendar feature for goal setting, planning, and recording of physical activity performance and progress, and (2) a small community feature for positive feedback and support from peers. All system requirements correlated with established BCTs, which were coded as 24 different BCTs. Conclusions: To our knowledge, this study is the first to involve individuals with RA as co-designers, in collaboration with clinicians, researchers, and Web designers, to produce basic data to generate system requirement specifications for an eHealth service. The system requirements correlated to the BCTs, making specifications of content and future evaluation of effectiveness possible. %M 25665589 %R 10.2196/resprot.3795 %U http://www.researchprotocols.org/2015/1/e22/ %U https://doi.org/10.2196/resprot.3795 %U http://www.ncbi.nlm.nih.gov/pubmed/25665589 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 2 %P e38 %T Effectiveness of a Web-Based, Computer-Tailored, Pedometer-Based Physical Activity Intervention for Adults: A Cluster Randomized Controlled Trial %A Compernolle,Sofie %A Vandelanotte,Corneel %A Cardon,Greet %A De Bourdeaudhuij,Ilse %A De Cocker,Katrien %+ Physical Activity, Fitness and Health, Department of Movement and Sports Sciences, Ghent University, 3th floor, Watersportlaan 2, Gent, 9000, Belgium, 32 9 264 63 21, sofie.compernolle@ugent.be %K physical activity %K computer tailoring %K Web-based intervention %K cluster randomized controlled trial %D 2015 %7 09.02.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Computer-tailored physical activity (PA) interventions delivered through the Internet represent a promising and appealing method to promote PA at a population level. However, personalized advice is mostly provided based on subjectively measured PA, which is not very accurate and might result in the delivery of advice that is not credible or effective. Therefore, an innovative computer-tailored PA advice was developed, based on objectively pedometer-measured PA. Objective: The study aim was to evaluate the effectiveness of a computer-tailored, pedometer-based PA intervention in working adults. Methods: Participants (≥18 years) were recruited between May and December 2012 from eight Flemish workplaces. These workplaces were allocated randomly to an intervention or control group. Intervention group participants (n=137) received (1) a booklet with information on how to increase their steps, (2) a non-blinded pedometer, and (3) an Internet link to request computer-tailored step advice. Control group participants (n=137) did not receive any of the intervention components. Self-reported and pedometer-based PA were assessed at baseline (T0), and 1 month (T1) and 3 months (T2) months post baseline. Repeated measures analyses of covariance were used to examine intervention effects for both the total sample and the at-risk sample (ie, adults not reaching 10,000 steps a day at baseline). Results: The recruitment process resulted in 274 respondents (response rate of 15.1%) who agreed to participate, of whom 190 (69.3%) belonged to the at-risk sample. Between T0 and T1 (1-month post baseline), significant intervention effects were found for participants’ daily step counts in both the total sample (P=.004) and the at-risk sample (P=.001). In the at-risk sample, the intervention effects showed a daily step count increase of 1056 steps in the intervention group, compared to a decrease of 258 steps in the control group. Comparison of participants’ self-reported PA revealed a significant intervention effect for time spent walking in the at-risk sample (P=.02). Intervention effects were still significant 3 months post baseline for participants’ daily step counts in both the total sample (P=.03) and the at-risk sample (P=.02); however, self-reported PA differences were no longer significant. Conclusions: A computer-tailored, pedometer-based PA intervention was effective in increasing both pedometer-based and self-reported PA levels, mainly in the at-risk participants. However, more effort should be devoted to recruit and retain participants in order to improve the public health impact of the intervention. Trial Registration: ClinicalTrials.gov: NCT02080585; https://clinicaltrials.gov/ct2/show/NCT02080585 (Archived by WebCite at http://www.webcitation.org/6VvQnRQSy). %M 25665498 %R 10.2196/jmir.3402 %U http://www.jmir.org/2015/2/e38/ %U https://doi.org/10.2196/jmir.3402 %U http://www.ncbi.nlm.nih.gov/pubmed/25665498 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 2 %P e35 %T Drinker Prototype Alteration and Cue Reminders as Strategies in a Tailored Web-Based Intervention Reducing Adults’ Alcohol Consumption: Randomized Controlled Trial %A van Lettow,Britt %A de Vries,Hein %A Burdorf,Alex %A Boon,Brigitte %A van Empelen,Pepijn %+ TNO, Research Group Life Style, Schipholweg 77-89, Leiden, 2316 ZL Leiden, Netherlands, 31 888662711, pepijn.vanempelen@tno.nl %K Internet %K intervention studies %K prototypes %K drinking %K intention %K willingness %K adults %K randomized controlled trial %D 2015 %7 04.02.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Excessive alcohol use is a prevalent and worldwide problem. Excessive drinking causes a significant burden of disease and is associated with both morbidity and excess mortality. Prototype alteration and provision of a cue reminder could be useful strategies to enhance the effectiveness of online tailored interventions for excessive drinking. Objective: Through a Web-based randomized controlled trial, 2 strategies (ie, prototype alteration and cue reminders) within an existing online personalized feedback intervention (Drinktest) aimed to reduce adults’ excessive drinking. It was expected that both strategies would add to Drinktest and would result in reductions in alcohol consumption by intrinsic motivation and the seizure of opportunities to act. Methods: Participants were recruited online and through printed materials. Excessive drinking adults (N=2634) were randomly assigned to 4 conditions: original Drinktest, Drinktest plus prototype alteration, Drinktest plus cue reminder, and Drinktest plus prototype alteration and cue reminder. Evaluation took place at 1-month posttest and 6-month follow-up. Differences in drinking behavior, intentions, and behavioral willingness (ie, primary outcomes) were assessed by means of longitudinal multilevel analyses using a last observation carried forward method. Measures were based on self-reports. Results: All conditions showed reductions in drinking behavior and willingness to drink, and increased intentions to reduce drinking. Prototype alteration (B=–0.15, P<.05) and cue reminder usage (B=–0.15, P<.05) were both more effective in reducing alcohol consumption than when these strategies were not provided. Combining the strategies did not produce a synergistic effect. No differences across conditions were found regarding intentions or willingness. Conclusions: Although individuals’ awareness of their cue was reasonable, their reported alcohol consumption was nevertheless reduced. Individuals appeared to distance their self-image from heavier drinking prototypes. Thus, prototype alteration and cue reminder usage may be feasible and simple intervention strategies to promote reductions in alcohol consumption among adults, with an effect up to 6 months. Trial Registration: Nederlands Trial Register (NTR): 4169; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4169 (Archived by WebCite at http://www.webcitation.org/6VD2jnxmB). %M 25653199 %R 10.2196/jmir.3551 %U http://www.jmir.org/2015/2/e35/ %U https://doi.org/10.2196/jmir.3551 %U http://www.ncbi.nlm.nih.gov/pubmed/25653199 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 1 %P e30 %T The Person-Based Approach to Intervention Development: Application to Digital Health-Related Behavior Change Interventions %A Yardley,Lucy %A Morrison,Leanne %A Bradbury,Katherine %A Muller,Ingrid %+ Department of Psychology, Faculty of Social and Human Sciences, University of Southampton, Department of Psychology, Highfield campus, Southampton, SO17 1BJ, United Kingdom, 44 2380 594581, L.Yardley@soton.ac.uk %K person-based approach %K Internet %K qualitative research %K evaluation studies %K feasibility studies %K health promotion %K patient education %K professional education %K behavior change. %D 2015 %7 30.01.2015 %9 Viewpoint %J J Med Internet Res %G English %X This paper describes an approach that we have evolved for developing successful digital interventions to help people manage their health or illness. We refer to this as the “person-based” approach to highlight the focus on understanding and accommodating the perspectives of the people who will use the intervention. While all intervention designers seek to elicit and incorporate the views of target users in a variety of ways, the person-based approach offers a distinctive and systematic means of addressing the user experience of intended behavior change techniques in particular and can enhance the use of theory-based and evidence-based approaches to intervention development. There are two key elements to the person-based approach. The first is a developmental process involving qualitative research with a wide range of people from the target user populations, carried out at every stage of intervention development, from planning to feasibility testing and implementation. This process goes beyond assessing acceptability, usability, and satisfaction, allowing the intervention designers to build a deep understanding of the psychosocial context of users and their views of the behavioral elements of the intervention. Insights from this process can be used to anticipate and interpret intervention usage and outcomes, and most importantly to modify the intervention to make it more persuasive, feasible, and relevant to users. The second element of the person-based approach is to identify “guiding principles” that can inspire and inform the intervention development by highlighting the distinctive ways that the intervention will address key context-specific behavioral issues. This paper describes how to implement the person-based approach, illustrating the process with examples of the insights gained from our experience of carrying out over a thousand interviews with users, while developing public health and illness management interventions that have proven effective in trials involving tens of thousands of users. %M 25639757 %R 10.2196/jmir.4055 %U http://www.jmir.org/2015/1/e30/ %U https://doi.org/10.2196/jmir.4055 %U http://www.ncbi.nlm.nih.gov/pubmed/25639757 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 3 %N 1 %P e10 %T Quit4baby: Results From a Pilot Test of a Mobile Smoking Cessation Program for Pregnant Women %A Abroms,Lorien C %A Johnson,Pamela R %A Heminger,Christina L %A Van Alstyne,Judith M %A Leavitt,Leah E %A Schindler-Ruwisch,Jennifer M %A Bushar,Jessica A %+ Milken Institute School of Public Health, Prevention & Community Health, The George Washington University, 950 New Hampshire Avenue NW, 3rd floor, Washington, DC, 20052, United States, 1 202 994 3518, lorien@gwu.edu %K mobile health %K tobacco cessation %K pregnancy %K text messaging %D 2015 %7 23.01.2015 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: Text messaging (short message service, SMS) programs have been shown to be effective in helping adult smokers quit smoking. This study describes the results of a pilot test of Quit4baby, a smoking cessation text messaging program for pregnant smokers that was adapted from Text2quit. Objective: The study aimed to demonstrate the feasibility and acceptability of Quit4baby for women currently enrolled in Text4baby, a perinatal health text messaging program. Methods: Pregnant women enrolled in Text4baby and who were current smokers or had quit within the last 4 weeks (n=20) were enrolled in Quit4baby. Those under the age of 18, not pregnant, not current smokers, those using nicotine replacement therapy, and those not interested in participating were ineligible. Participants were surveyed at baseline and at 2 and 4 weeks postenrollment. Results: Most participants responded to the program favorably. Highly rated aspects included the content of the program, skills taught within the program, and encouragement and social support provided by the program. Participants reported that the program was helpful in quitting, that the program gave good ideas on quitting, and that they would recommend the program to a friend. Suggestions for improvement included increasing the message dose and making the quitpal more interactive. Conclusions: This pilot test provides support for the feasibility and acceptability of Quit4baby. Future studies are needed to assess whether Quit4baby is effective for smoking cessation during pregnancy. %M 25650765 %R 10.2196/mhealth.3846 %U http://mhealth.jmir.org/2015/1/e10/ %U https://doi.org/10.2196/mhealth.3846 %U http://www.ncbi.nlm.nih.gov/pubmed/25650765 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 1 %P e28 %T Developing Internet-Based Health Interventions: A Guide for Public Health Researchers and Practitioners %A Horvath,Keith J %A Ecklund,Alexandra M %A Hunt,Shanda L %A Nelson,Toben F %A Toomey,Traci L %+ Division of Epidemiology and Community Health, University of Minnesota, 1300 S. 2nd Street, Suite 300, Minneapolis, MN, 55454, United States, 1 612 626 1799, horva018@umn.edu %K Internet %K public health %K intervention %K development %D 2015 %7 23.01.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Researchers and practitioners interested in developing online health interventions most often rely on Web-based and print resources to guide them through the process of online intervention development. Although useful for understanding many aspects of best practices for website development, missing from these resources are concrete examples of experiences in online intervention development for health apps from the perspective of those conducting online health interventions. Objective: This study aims to serve as a series of case studies in the development of online health interventions to provide insights for researchers and practitioners who are considering technology-based interventional or programmatic approaches. Methods: A convenience sample of six study coordinators and five principal investigators at a large, US-based land grant university were interviewed about the process of developing online interventions in the areas of alcohol policy, adolescent health, medication adherence, and human immunodeficiency virus prevention in transgender persons and in men who have sex with men. Participants were asked questions that broadly addressed each of the four phases of the User-Centered Design Process Map from the US Department of Health and Human Services' Research-Based Web Design & Usability Guidelines. Interviews were audio recorded and transcribed. Qualitative codes were developed using line-by-line open coding for all transcripts, and all transcripts were coded independently by at least 2 authors. Differences among coders were resolved with discussion. Results: We identified the following seven themes: (1) hire a strong (or at least the right) research team, (2) take time to plan before beginning the design process, (3) recognize that vendors and researchers have differing values, objectives, and language, (4) develop a detailed contract, (5) document all decisions and development activities, (6) use a content management system, and (7) allow extra time for testing and debugging your intervention. Each of these areas is discussed in detail, with supporting quotations from principal investigators and study coordinators. Conclusions: The values held by members of each participating organization involved in the development of the online intervention or program, as well as the objectives that are trying to be met with the website, must be considered. These defined values and objectives should prompt an open and explicit discussion about the scope of work, budget, and other needs from the perspectives of each organization. Because of the complexity of developing online interventions, researchers and practitioners should become familiar with the process and how it may differ from the development and implementation of in-person interventions or programs. To assist with this, the intervention team should consider expanding the team to include experts in computer science or learning technologies, as well as taking advantage of institutional resources that will be needed for successful completion of the project. Finally, we describe the tradeoff between funds available for online intervention or program development and the complexity of the project. %M 25650702 %R 10.2196/jmir.3770 %U http://www.jmir.org/2015/1/e28/ %U https://doi.org/10.2196/jmir.3770 %U http://www.ncbi.nlm.nih.gov/pubmed/25650702 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 1 %P e3 %T A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol %A Block,Gladys %A Azar,Kristen MJ %A Block,Torin J %A Romanelli,Robert J %A Carpenter,Heather %A Hopkins,Donald %A Palaniappan,Latha %A Block,Clifford H %+ NutritionQuest, Inc., 15 Shattuck Square, Suite 288, Berkeley, CA, 94704, United States, 1 510 704 8514, gblock@berkeley.edu %K prediabetes %K insulin resistance %K diabetes %K prevention %K obesity %K physical activity %K internet %K world wide web %K blood glucose %K metabolic syndrome %D 2015 %7 21.01.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Objective: Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Methods: Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. Results: A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. Conclusions: The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or preventing progression of glycemic markers and indirectly in preventing progression to diabetes. Trial Registration: ClinicalTrials.gov NCT01479062; http://clinicaltrials.gov/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6U8ODy1vo). %M 25608692 %R 10.2196/resprot.4046 %U http://www.researchprotocols.org/2015/1/e3/ %U https://doi.org/10.2196/resprot.4046 %U http://www.ncbi.nlm.nih.gov/pubmed/25608692 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 1 %P e23 %T Short- and Medium-Term Efficacy of a Web-Based Computer-Tailored Nutrition Education Intervention for Adults Including Cognitive and Environmental Feedback: Randomized Controlled Trial %A Springvloet,Linda %A Lechner,Lilian %A de Vries,Hein %A Candel,Math JJM %A Oenema,Anke %+ Maastricht University, Department of Health Promotion, School for Public Health and Primary Care (CAPHRI), P.O. Box 616, Maastricht, 6200 MD, Netherlands, 31 43 388 24 17, linda.springvloet@maastrichtuniversity.nl %K cognitive feedback %K environmental feedback %K self-regulation %K computer tailoring %K nutrition education %K fruit consumption %K vegetable consumption %K fat consumption %K snack consumption %D 2015 %7 19.01.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based, computer-tailored nutrition education interventions can be effective in modifying self-reported dietary behaviors. Traditional computer-tailored programs primarily targeted individual cognitions (knowledge, awareness, attitude, self-efficacy). Tailoring on additional variables such as self-regulation processes and environmental-level factors (the home food environment arrangement and perception of availability and prices of healthy food products in supermarkets) may improve efficacy and effect sizes (ES) of Web-based computer-tailored nutrition education interventions. Objective: This study evaluated the short- and medium-term efficacy and educational differences in efficacy of a cognitive and environmental feedback version of a Web-based computer-tailored nutrition education intervention on self-reported fruit, vegetable, high-energy snack, and saturated fat intake compared to generic nutrition information in the total sample and among participants who did not comply with dietary guidelines (the risk groups). Methods: A randomized controlled trial was conducted with a basic (tailored intervention targeting individual cognition and self-regulation processes; n=456), plus (basic intervention additionally targeting environmental-level factors; n=459), and control (generic nutrition information; n=434) group. Participants were recruited from the general population and randomly assigned to a study group. Self-reported fruit, vegetable, high-energy snack, and saturated fat intake were assessed at baseline and at 1- (T1) and 4-months (T2) postintervention using online questionnaires. Linear mixed model analyses examined group differences in change over time. Educational differences were examined with group×time×education interaction terms. Results: In the total sample, the basic (T1: ES=–0.30; T2: ES=–0.18) and plus intervention groups (T1: ES=–0.29; T2: ES=–0.27) had larger decreases in high-energy snack intake than the control group. The basic version resulted in a larger decrease in saturated fat intake than the control intervention (T1: ES=–0.19; T2: ES=–0.17). In the risk groups, the basic version caused larger decreases in fat (T1: ES=–0.28; T2: ES=–0.28) and high-energy snack intake (T1: ES=–0.34; T2: ES=–0.20) than the control intervention. The plus version resulted in a larger increase in fruit (T1: ES=0.25; T2: ES=0.37) and a larger decrease in high-energy snack intake (T1: ES=–0.38; T2: ES=–0.32) than the control intervention. For high-energy snack intake, educational differences were found. Stratified analyses showed that the plus version was most effective for high-educated participants. Conclusions: Both intervention versions were more effective in improving some of the self-reported dietary behaviors than generic nutrition information, especially in the risk groups, among both higher- and lower-educated participants. For fruit intake, only the plus version was more effective than providing generic nutrition information. Although feasible, incorporating environmental-level information is time-consuming. Therefore, the basic version may be more feasible for further implementation, although inclusion of feedback on the arrangement of the home food environment and on availability and prices may be considered for fruit and, for high-educated people, for high-energy snack intake. Trial Registration: Netherlands Trial Registry NTR3396; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3396 (Archived by WebCite at http://www.webcitation.org/6VNZbdL6w). %M 25599828 %R 10.2196/jmir.3837 %U http://www.jmir.org/2015/1/e23/ %U https://doi.org/10.2196/jmir.3837 %U http://www.ncbi.nlm.nih.gov/pubmed/25599828 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 1 %P e8 %T Enhancing Web-Based Mindfulness Training for Mental Health Promotion With the Health Action Process Approach: Randomized Controlled Trial %A Mak,Winnie WS %A Chan,Amy TY %A Cheung,Eliza YL %A Lin,Cherry LY %A Ngai,Karin CS %+ Diversity & Well-Being Laboratory, Department of Psychology, The Chinese University of Hong Kong, 3rd Floor, Sino Building, Shatin, NT, Hong Kong, 999077, China (Hong Kong), 852 39436577, wwsmak@psy.cuhk.edu.hk %K Internet-based intervention %K online intervention %K mindfulness %K Health Action Process Approach (HAPA) %K mental health promotion %D 2015 %7 19.01.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: With increasing evidence demonstrating the effectiveness of Web-based interventions and mindfulness-based training in improving health, delivering mindfulness training online is an attractive proposition. Objective: The aim of this study was to evaluate the efficacy of two Internet-based interventions (basic mindfulness and Health Action Process Approach enhanced mindfulness) with waitlist control. Health Action Process Approach (HAPA) principles were used to enhance participants’ efficacy and planning. Methods: Participants were recruited online and offline among local universities; 321 university students and staff were randomly assigned to three conditions. The basic and HAPA-enhanced groups completed the 8-week fully automated mindfulness training online. All participants (including control) were asked to complete an online questionnaire pre-program, post-program, and at 3-month follow-up. Results: Significant group by time interaction effect was found. The HAPA-enhanced group showed significantly higher levels of mindfulness from pre-intervention to post-intervention, and such improvement was sustained at follow-up. Both the basic and HAPA-enhanced mindfulness groups showed better mental well-being from pre-intervention to post-intervention, and improvement was sustained at 3-month follow-up. Conclusions: Online mindfulness training can improve mental health. An online platform is a viable medium to implement and disseminate evidence-based interventions and is a highly scalable approach to reach the general public. Trial Registration: Chinese Clinical Trial Registry (ChiCTR): ChiCTR-TRC-12002954; http://www.chictr.org/en/proj/show.aspx?proj=3904 (Archived by WebCite at http://www.webcitation.org/6VCdG09pA). %M 25599904 %R 10.2196/jmir.3746 %U http://www.jmir.org/2015/1/e8/ %U https://doi.org/10.2196/jmir.3746 %U http://www.ncbi.nlm.nih.gov/pubmed/25599904 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 1 %P e17 %T A Mobile App to Aid Smoking Cessation: Preliminary Evaluation of SmokeFree28 %A Ubhi,Harveen Kaur %A Michie,Susan %A Kotz,Daniel %A Wong,Wai Chi %A West,Robert %+ Cancer Research UK Health Behaviour Research Centre, Department of Epidemiology and Public Health, University College London, 1-19 Torrington Place, London, WC1E 6BT, United Kingdom, 44 789 134 0056, harveenk26@gmail.com %K smoking cessation intervention %K mobile %K smartphone %K apps %K PRIME theory %D 2015 %7 16.01.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Little is known about the effectiveness of mobile apps in aiding smoking cessation or their validity for automated collection of data on smoking cessation outcomes. Objective: We conducted a preliminary evaluation of SF28 (SF28 is the name of the app, short for SmokeFree28)—an app aimed at helping smokers to be smoke-free for 28 days. Methods: Data on sociodemographic characteristics, smoking history, number of logins, and abstinence at each login were uploaded to a server from SF28 between August 2012 and August 2013. Users were included if they were aged 16 years or over, smoked cigarettes at the time of registration, had set a quit date, and used the app at least once on or after their quit date. Their characteristics were compared with data from a representative sample of smokers trying to stop smoking in England. The percentage of users recording 28 days of abstinence was compared with a value of 15% estimated for unaided quitting. Correlations were assessed between recorded abstinence for 28 days and well-established abstinence predictors. Results: A total of 1170 users met the inclusion criteria. Compared with smokers trying to quit in England, they had higher consumption, and were younger, more likely to be female, and had a non-manual rather than manual occupation. In total, 18.9% (95% CI 16.7-21.1) were recorded as being abstinent from smoking for 28 days or longer. The mean number of logins was 8.5 (SD 9.0). The proportion recording abstinence for 28 days or longer was higher in users who were older, in a non-manual occupation, and in those using a smoking cessation medication. Conclusions: The recorded 28-day abstinence rates from the mobile app, SF28, suggest that it may help some smokers to stop smoking. Further evaluation by means of a randomized trial appears to be warranted. %M 25596170 %R 10.2196/jmir.3479 %U http://www.jmir.org/2015/1/e17/ %U https://doi.org/10.2196/jmir.3479 %U http://www.ncbi.nlm.nih.gov/pubmed/25596170 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 1 %P e6 %T Development and Evaluation of an Educational E-Tool to Help Patients With Non-Hodgkin's Lymphoma Manage Their Personal Care Pathway %A Stienen,Jozette JC %A Ottevanger,Petronella B %A Wennekes,Lianne %A Dekker,Helena M %A van der Maazen,Richard WM %A Mandigers,Caroline MPW %A van Krieken,Johan HJM %A Blijlevens,Nicole MA %A Hermens,Rosella PMG %+ Radboud university medical center, Scientific Institute for Quality of Healthcare (IQ healthcare), PO Box 9101 (114), Nijmegen, 6500 HB, Netherlands, 31 24 36 67 310, JozetteStienen@gmail.com %K eHealth %K personalized care %K non-Hodgkin’s lymphoma %K patient education %K care pathway %K consumer health information %K empowerment %K personal care management %D 2015 %7 09.01.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: An overload of health-related information is available for patients on numerous websites, guidelines, and information leaflets. However, the increasing need for personalized health-related information is currently unmet. Objective: This study evaluates an educational e-tool for patients with non-Hodgkin’s lymphoma (NHL) designed to meet patient needs with respect to personalized and complete health-related information provision. The e-tool aims to help NHL patients manage and understand their personal care pathway, by providing them with insight into their own care pathway, the possibility to keep a diary, and structured health-related information. Methods: Together with a multidisciplinary NHL expert panel, we developed an e-tool consisting of two sections: (1) a personal section for patients’ own care pathway and their experiences, and (2) an informative section including information on NHL. We developed an ideal NHL care pathway based on the available (inter)national guidelines. The ideal care pathway, including date of first consultation, diagnosis, and therapy start, was used to set up the personal care pathway. The informative section was developed in collaboration with the patient association, Hematon. Regarding participants, 14 patients and 6 laymen were asked to evaluate the e-tool. The 24-item questionnaire used discussed issues concerning layout (6 questions), user convenience (3 questions), menu clarity (3 questions), information clarity (5 questions), and general impression (7 questions). In addition, the panel members were asked to give their feedback by email. Results: A comprehensive overview of diagnostics, treatments, and aftercare can be established by patients completing the questions from the personal section. The informative section consisted of NHL information regarding NHL in general, diagnostics, therapy, aftercare, and waiting times. Regarding participants, 6 patients and 6 laymen completed the questionnaire. Overall, the feedback was positive, with at least 75% satisfaction on each feedback item. Important strengths mentioned were the use of a low health-literacy level, the opportunity to document the personal care pathway and experiences, and the clear overview of the information provided. The added value of the e-tool in general was pointed out as very useful for preparing the consultation with one’s doctor and for providing all information on one website, including the opportunity for a personalized care pathway and diary. The majority of the revisions concerned wording and clarity. In addition, more explicit information on immunotherapy, experimental therapy, and psychosocial support was added. Conclusions: We have developed a personal care management e-tool for NHL patients. This tool contains a unique way to help patients manage their personal care pathway and give them insight into their NHL by providing health-related information and a personal diary. This evaluation showed that our e-tool meets patients’ needs concerning personalized health-related information, which might serve as a good example for other oncologic diseases. Future research should focus on the possible impact of the e-tool on doctor-patient communication during consultations. %M 25575019 %R 10.2196/resprot.3407 %U http://www.researchprotocols.org/2015/1/e6/ %U https://doi.org/10.2196/resprot.3407 %U http://www.ncbi.nlm.nih.gov/pubmed/25575019 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 1 %P e14 %T The Effect of Social Support Features and Gamification on a Web-Based Intervention for Rheumatoid Arthritis Patients: Randomized Controlled Trial %A Allam,Ahmed %A Kostova,Zlatina %A Nakamoto,Kent %A Schulz,Peter Johannes %+ Institute of Communication and Health, Faculty of Communication Sciences, University of Lugano (Università della Svizzera italiana), Blue Building, 1st floor, 13 G Buffi street, Lugano, 6900, Switzerland, 41 41 58 666 4821, ahmed.allam@usi.ch %K social support %K gaming %K experimental games %K eHealth %K rheumatoid arthritis %K randomized controlled trial %K multilevel analysis %K patient empowerment %K physical activity %K health care utilization %D 2015 %7 09.01.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Rheumatoid arthritis (RA) is chronic systematic disease that affects people during the most productive period of their lives. Web-based health interventions have been effective in many studies; however, there is little evidence and few studies showing the effectiveness of online social support and especially gamification on patients’ behavioral and health outcomes. Objective: The aim of this study was to look into the effects of a Web-based intervention that included online social support features and gamification on physical activity, health care utilization, medication overuse, empowerment, and RA knowledge of RA patients. The effect of gamification on website use was also investigated. Methods: We conducted a 5-arm parallel randomized controlled trial for RA patients in Ticino (Italian-speaking part of Switzerland). A total of 157 patients were recruited through brochures left with physicians and were randomly allocated to 1 of 4 experimental conditions with different types of access to online social support and gamification features and a control group that had no access to the website. Data were collected at 3 time points through questionnaires at baseline, posttest 2 months later, and at follow-up after another 2 months. Primary outcomes were physical activity, health care utilization, and medication overuse; secondary outcomes included empowerment and RA knowledge. All outcomes were self-reported. Intention-to-treat analysis was followed and multilevel linear mixed models were used to study the change of outcomes over time. Results: The best-fit multilevel models (growth curve models) that described the change in the primary outcomes over the course of the intervention included time and empowerment as time-variant predictors. The growth curve analyses of experimental conditions were compared to the control group. Physical activity increased over time for patients having access to social support sections plus gaming (unstandardized beta coefficient [B]=3.39, P=.02). Health care utilization showed a significant decrease for patients accessing social support features (B=–0.41, P=.01) and patients accessing both social support features and gaming (B=–0.33, P=.03). Patients who had access to either social support sections or the gaming experience of the website gained more empowerment (B=2.59, P=.03; B=2.29, P=.05; respectively). Patients who were offered a gamified experience used the website more often than the ones without gaming (t91=–2.41, P=.02; U=812, P=.02). Conclusions: The Web-based intervention had a positive impact (more desirable outcomes) on intervention groups compared to the control group. Social support sections on the website decreased health care utilization and medication overuse and increased empowerment. Gamification alone or with social support increased physical activity and empowerment and decreased health care utilization. This study provides evidence demonstrating the potential positive effect of gamification and online social support on health and behavioral outcomes. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 57366516; http://www.controlled-trials. com/ISRCTN57366516 (Archived by webcite at http://www.webcitation.org/6PBvvAvvV). %M 25574939 %R 10.2196/jmir.3510 %U http://www.jmir.org/2015/1/e14/ %U https://doi.org/10.2196/jmir.3510 %U http://www.ncbi.nlm.nih.gov/pubmed/25574939 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 1 %P e6 %T Virtual Intervention to Support Self-Management of Antiretroviral Therapy Among People Living With HIV %A Côté,José %A Godin,Gaston %A Ramirez-Garcia,Pilar %A Rouleau,Geneviève %A Bourbonnais,Anne %A Guéhéneuc,Yann-Gaël %A Tremblay,Cécile %A Otis,Joanne %+ Research Center of the Centre Hospitalier de l’Université de Montréal, 850 rue St-Denis, Tour St-Antoine, third floor, Door S03-424, Montreal, QC, , Canada, 1 514 890 8000 ext 15536, jose.cote@umontreal.ca %K adherence %K antiretroviral therapy, highly active %K HIV-infected patients %K human immunodeficiency virus %K nursing %K nursing informatics %K Web-based intervention %D 2015 %7 06.01.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Living with human immunodeficiency virus (HIV) necessitates long-term health care follow-up, particularly with respect to antiretroviral therapy (ART) management. Taking advantage of the enormous possibilities afforded by information and communication technologies (ICT), we developed a virtual nursing intervention (VIH-TAVIE) intended to empower HIV patients to manage their ART and their symptoms optimally. ICT interventions hold great promise across the entire continuum of HIV patient care but further research is needed to properly evaluate their effectiveness. Objective: The objective of the study was to compare the effectiveness of two types of follow-up—traditional and virtual—in terms of promoting ART adherence among HIV patients. Methods: A quasi-experimental study was conducted. Participants were 179 HIV patients on ART for at least 6 months, of which 99 were recruited at a site offering virtual follow-up and 80 at another site offering only traditional follow-up. The primary outcome was medication adherence and the secondary outcomes were the following cognitive and affective variables: self-efficacy, attitude toward medication intake, symptom-related discomfort, stress, and social support. These were evaluated by self-administered questionnaire at baseline (T0), and 3 (T3) and 6 months (T6) later. Results: On average, participants had been living with HIV for 14 years and had been on ART for 11 years. The groups were highly heterogeneous, differing on a number of sociodemographic dimensions: education, income, marital status, employment status, and living arrangements. Adherence at baseline was high, reaching 80% (59/74) in the traditional follow-up group and 84% (81/97) in the virtual follow-up group. A generalized estimating equations (GEE) analysis was run, controlling for sociodemographic characteristics at baseline. A time effect was detected indicating that both groups improved in adherence over time but did not differ in this regard. Improvement at 6 months was significantly greater than at 3 months in both groups. Analysis of variance revealed no significant group-by-time interaction effect on any of the secondary outcomes. A time effect was observed for the two kinds of follow-ups; both groups improved on symptom-related discomfort and social support. Conclusions: Results showed that both interventions improved adherence to ART. Thus, the two kinds of follow-up can be used to promote treatment adherence among HIV patients on ART. %M 25563775 %R 10.2196/jmir.3264 %U http://www.jmir.org/2015/1/e6/ %U https://doi.org/10.2196/jmir.3264 %U http://www.ncbi.nlm.nih.gov/pubmed/25563775 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 1 %P e1 %T Mobile-Web App to Self-Manage Low Back Pain: Randomized Controlled Trial %A Irvine,A Blair %A Russell,Holly %A Manocchia,Michael %A Mino,David E %A Cox Glassen,Terri %A Morgan,Rebecca %A Gau,Jeff M %A Birney,Amelia J %A Ary,Dennis V %+ ORCAS, PO Box 1226, Eugene, OR, 97440, United States, 1 541 342 7227, abirney@orcasinc.com %K low back pain %K Internet %K mobile %K app %K computers %K prevention %K self-treatment %D 2015 %7 02.01.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Nonspecific low back pain (NLBP) is the diagnosis for individuals with back pain that has no underlying medical cause (eg, tumor, infection, fracture, herniated disc, spinal stenosis). The American College of Physicians (ACP) and American Pain Society (APS) recommend multidisciplinary treatments for NLBP that lasts more than 4 weeks. This approach, however, is impractical for many physicians to implement, and relatively few providers offer NLBP treatment that meets the joint ACP-APS guidelines. Objective: This study evaluated the efficacy of a mobile-Web intervention called “FitBack” to help users implement self-tailored strategies to manage and prevent NLBP occurrences. Methods: A total of 597 adults were recruited, screened, consented, and assessed online at baseline, at 2 months (T2), and at 4 months (T3). After baseline assessments, participants were randomized into three groups: FitBack intervention, alternative care group that received 8 emails urging participants to link to six Internet resources for NLBP, and control group. The FitBack group also received weekly email reminder prompts for 8 weeks plus emails to do assessments. The control group was only contacted to do assessments. Results: Users of the FitBack program showed greater improvement compared to the control group in every comparison of the critical physical, behavioral, and worksite outcome measures at 4-month follow-up. In addition, users of the FitBack program performed better than the alternative care group on current back pain, behavioral, and worksite outcomes at 4-month follow-up. For example, subjects in the control group were 1.7 times more likely to report current back pain than subjects in the FitBack group; subjects in the alternative care group were 1.6 times more likely to report current back pain at 4-month follow-up. Further, the users of the FitBack program showed greater improvement compared to both the control and alternative care groups at 4-month follow-up on patient activation, constructs of the Theory of Planned Behavior, and attitudes toward pain. Conclusions: This research demonstrated that a theoretically based stand-alone mobile-Web intervention that tailors content to users’ preferences and interests can be an effective tool in self-management of low back pain. When viewed from the RE-AIM perspective (ie, reach, efficacy/effectiveness, adoption, implementation fidelity, and maintenance), this study supports the notion that there is considerable value in this type of intervention as a potentially cost-effective tool that can reach large numbers of people. The results are promising considering that the FitBack intervention was neither supported by professional caregivers nor integrated within a health promotion campaign, which might have provided additional support for participants. Still, more research is needed on how self-guided mobile-Web interventions will be used over time and to understand factors associated with continuing user engagement. Trial Registration: Clinicaltrials.gov NCT01950091; http://clinicaltrials.gov/ct2/show/NCT01950091 (Archived by WebCite at http://www.webcitation.org/6TwZucX77). %M 25565416 %R 10.2196/jmir.3130 %U http://www.jmir.org/2015/1/e1/ %U https://doi.org/10.2196/jmir.3130 %U http://www.ncbi.nlm.nih.gov/pubmed/25565416 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 12 %P e245 %T Retaining Critical Therapeutic Elements of Behavioral Interventions Translated For Delivery via the Internet: Recommendations and an Example Using Pain Coping Skills Training %A Rini,Christine %A Porter,Laura S %A Somers,Tamara J %A McKee,Daphne C %A Keefe,Francis J %+ UNC Lineberger Comprehensive Cancer Center, School of Medicine, CB# 7295, Chapel Hill, NC, 27599-7295, United States, 1 919 966 3036, christine.rini@unc.edu %K psychotherapeutic processes %K cognitive behavioral therapy %K Internet %K eHealth %K intervention %K treatment efficacy %K musculoskeletal pain %K osteoarthritis %D 2014 %7 19.12.2014 %9 Viewpoint %J J Med Internet Res %G English %X Evidence supporting the efficacy of behavioral interventions based on principles of cognitive behavioral therapies has spurred interest in translating these interventions for delivery via the Internet. However, the benefits of this dissemination method cannot be realized unless the translated interventions are as effective as possible. We describe a challenge that must be overcome to ensure this occurs—Internet interventions must retain therapeutic components and processes underlying the success of face-to-face interventions on which they are based. These components and processes vary in the ease with which they can be translated to the online environment. Moreover, some are subtle and may be overlooked, despite being recognized as essential to the success of face-to-face interventions. We provide preliminary guidance for retaining critical therapeutic components and processes in the translation process, using Pain Coping Skills Training for osteoarthritis pain to illustrate methods. Directions for future research are also discussed. %M 25532216 %R 10.2196/jmir.3374 %U http://www.jmir.org/2014/12/e245/ %U https://doi.org/10.2196/jmir.3374 %U http://www.ncbi.nlm.nih.gov/pubmed/25532216 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 12 %P e295 %T Comparing Effects in Regular Practice of E-Communication and Web-Based Self-Management Support Among Breast Cancer Patients: Preliminary Results From a Randomized Controlled Trial %A Børøsund,Elin %A Cvancarova,Milada %A Moore,Shirley M %A Ekstedt,Mirjam %A Ruland,Cornelia M %+ Centre for Shared Decision Making and Collaborative Care Research, Division of Medicine, Oslo University Hospital, Pb 4950 Nydalen, Oslo, 0424, Norway, 47 23075460, cornelia.ruland@rr-research.no %K Web-based intervention %K electronic mail %K Internet %K eHealth %K cancer %K patient-centered care %K symptom management %K professional-patient relations %K randomized controlled trial %D 2014 %7 18.12.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: While Web-based interventions have been shown to assist a wide range of patients successfully in managing their illness, few studies have examined the relative contribution of different Web-based components to improve outcomes. Further efficacy trials are needed to test the effects of Web support when offered as a part of routine care. Objective: Our aim was to compare in regular care the effects of (1) an Internet-based patient provider communication service (IPPC), (2) WebChoice, a Web-based illness management system for breast cancer patients (IPPC included), and (3) usual care on symptom distress, anxiety, depression, (primary outcomes), and self-efficacy (secondary outcome). This study reports preliminary findings from 6 months’ follow-up data in a 12-month trial. Methods: We recruited 167 patients recently diagnosed with breast cancer and undergoing treatment from three Norwegian hospitals. The nurse-administered IPPC allowed patients to send secure e-messages to and receive e-messages from health care personnel at the hospital where they were treated. In addition to the IPPC, WebChoice contains components for symptom monitoring, tailored information and self-management support, a diary, and communication with other patients. A total of 20 care providers (11 nurses, 6 physicians, and 3 social workers) were trained to answer questions from patients. Outcomes were measured with questionnaires at study entry and at study months 2, 4, and 6. Linear mixed models for repeated measures were fitted to compare effects on outcomes over time. Results: Patients were randomly assigned to the WebChoice group (n=64), the IPPC group (n=45), or the usual care group (n=58). Response rates to questionnaires were 73.7% (123/167) at 2 months, 65.9 (110/167) at 4 months, and 62.3% (104/167) at 6 months. Attrition was similar in all study groups. Among those with access to WebChoice, 64% (41/64) logged on more than once and 39% (25/64) sent e-messages to care providers. In the IPPC group, 40% (18/45) sent e-messages. Linear mixed models analyses revealed that the WebChoice group reported significantly lower symptom distress (mean difference 0.16, 95% CI 0.06-0.25, P=.001), anxiety (mean difference 0.79, 95% CI 0.09-1.49, P=.03), and depression (mean difference 0.79, 95% CI 0.09-1.49, P=.03) compared with the usual care group. The IPPC group reported significant lower depression scores compared with the usual care group (mean difference 0.69, 95% CI 0.05-1.32, P=.03), but no differences were observed for symptom distress or anxiety. No significant differences in self-efficacy were found among the study groups. Conclusions: In spite of practice variations and moderate use of the interventions, our results suggest that offering Web support as part of regular care can be a powerful tool to help patients manage their illness. Our finding that a nurse-administered IPPC alone can significantly reduce depression is particularly promising. However, the multicomponent intervention WebChoice had additional positive effects. Trial Registration: Clinicaltrials.gov:NCT00971009; http://clinicaltrials.gov/show/NCT00971009 (Archived by WebCite at http://www.webcitation.org/6USKezP0Y). %M 25525672 %R 10.2196/jmir.3348 %U http://www.jmir.org/2014/12/e295/ %U https://doi.org/10.2196/jmir.3348 %U http://www.ncbi.nlm.nih.gov/pubmed/25525672 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 12 %P e280 %T Social Media and Mobile Apps for Health Promotion in Australian Indigenous Populations: Scoping Review %A Brusse,Carl %A Gardner,Karen %A McAullay,Daniel %A Dowden,Michelle %+ Australian Primary Health Care Research Institute, Research School of Population Health, Australian National University, Building 63, Mills & Eggleston Roads, Canberra, 2601, Australia, 61 6125 7875, karen.gardner@anu.edu.au %K health promotion %K indigenous health %K eHealth %D 2014 %7 10.12.2014 %9 Review %J J Med Internet Res %G English %X Background: Health promotion organizations are increasingly embracing social media technologies to engage end users in a more interactive way and to widely disseminate their messages with the aim of improving health outcomes. However, such technologies are still in their early stages of development and, thus, evidence of their efficacy is limited. Objective: The study aimed to provide a current overview of the evidence surrounding consumer-use social media and mobile software apps for health promotion interventions, with a particular focus on the Australian context and on health promotion targeted toward an Indigenous audience. Specifically, our research questions were: (1) What is the peer-reviewed evidence of benefit for social media and mobile technologies used in health promotion, intervention, self-management, and health service delivery, with regard to smoking cessation, sexual health, and otitis media? and (2) What social media and mobile software have been used in Indigenous-focused health promotion interventions in Australia with respect to smoking cessation, sexual health, or otitis media, and what is the evidence of their effectiveness and benefit? Methods: We conducted a scoping study of peer-reviewed evidence for the effectiveness of social media and mobile technologies in health promotion (globally) with respect to smoking cessation, sexual health, and otitis media. A scoping review was also conducted for Australian uses of social media to reach Indigenous Australians and mobile apps produced by Australian health bodies, again with respect to these three areas. Results: The review identified 17 intervention studies and seven systematic reviews that met inclusion criteria, which showed limited evidence of benefit from these interventions. We also found five Australian projects with significant social media health components targeting the Indigenous Australian population for health promotion purposes, and four mobile software apps that met inclusion criteria. No evidence of benefit was found for these projects. Conclusions: Although social media technologies have the unique capacity to reach Indigenous Australians as well as other underserved populations because of their wide and instant disseminability, evidence of their capacity to do so is limited. Current interventions are neither evidence-based nor widely adopted. Health promotion organizations need to gain a more thorough understanding of their technologies, who engages with them, why they engage with them, and how, in order to be able to create successful social media projects. %M 25498835 %R 10.2196/jmir.3614 %U http://www.jmir.org/2014/12/e280/ %U https://doi.org/10.2196/jmir.3614 %U http://www.ncbi.nlm.nih.gov/pubmed/25498835 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 12 %P e285 %T Automated Indexing of Internet Stories for Health Behavior Change: Weight Loss Attitude Pilot Study %A Manuvinakurike,Ramesh %A Velicer,Wayne F %A Bickmore,Timothy W %+ College of Computer and Information Science, Northeastern University, WVH202, 360 Hutington Ave, Boston, MA, 02115, United States, 1 617 373 5477, bickmore@ccs.neu.edu %K behavioral medicine %K natural language processing %K animation %K consumer health %K health informatics %K self-efficacy %D 2014 %7 09.12.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Automated health behavior change interventions show promise, but suffer from high attrition and disuse. The Internet abounds with thousands of personal narrative accounts of health behavior change that could not only provide useful information and motivation for others who are also trying to change, but an endless source of novel, entertaining stories that may keep participants more engaged than messages authored by interventionists. Objective: Given a collection of relevant personal health behavior change stories gathered from the Internet, the aim of this study was to develop and evaluate an automated indexing algorithm that could select the best possible story to provide to a user to have the greatest possible impact on their attitudes toward changing a targeted health behavior, in this case weight loss. Methods: An indexing algorithm was developed using features informed by theories from behavioral medicine together with text classification and machine learning techniques. The algorithm was trained using a crowdsourced dataset, then evaluated in a 2×2 between-subjects randomized pilot study. One factor compared the effects of participants reading 2 indexed stories vs 2 randomly selected stories, whereas the second factor compared the medium used to tell the stories: text or animated conversational agent. Outcome measures included changes in self-efficacy and decisional balance for weight loss before and after the stories were read. Results: Participants were recruited from a crowdsourcing website (N=103; 53.4%, 55/103 female; mean age 35, SD 10.8 years; 65.0%, 67/103 precontemplation; 19.4%, 20/103 contemplation for weight loss). Participants who read indexed stories exhibited a significantly greater increase in self-efficacy for weight loss compared to the control group (F1,107=5.5, P=.02). There were no significant effects of indexing on change in decisional balance (F1,97=0.05, P=.83) and no significant effects of medium on change in self-efficacy (F1,107=0.04, P=.84) or decisional balance (F1,97=0.78, P=.38). Conclusions: Personal stories of health behavior change can be harvested from the Internet and used directly and automatically in interventions to affect participant attitudes, such as self-efficacy for changing behavior. Such approaches have the potential to provide highly tailored interventions that maximize engagement and retention with minimal intervention development effort. %M 25491243 %R 10.2196/jmir.3702 %U http://www.jmir.org/2014/12/e285/ %U https://doi.org/10.2196/jmir.3702 %U http://www.ncbi.nlm.nih.gov/pubmed/25491243 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 2 %N 4 %P e54 %T SMARTHealth India: Development and Field Evaluation of a Mobile Clinical Decision Support System for Cardiovascular Diseases in Rural India %A Praveen,Devarsetty %A Patel,Anushka %A Raghu,Arvind %A Clifford,Gari D %A Maulik,Pallab K %A Mohammad Abdul,Ameer %A Mogulluru,Kishor %A Tarassenko,Lionel %A MacMahon,Stephen %A Peiris,David %+ The George Institute for Global Health, India, 301, 2nd floor, ANR centre, Road no 1, Banjara Hills, Hyderabad, 500034, India, 91 9959777623, dpraveen@georgeinstitute.org.in %K clinical decision support systems %K mobile health %K developing countries %K community health worker %K primary health care %K cardiovascular disease %D 2014 %7 08.12.2014 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: Cardiovascular disease (CVD) is the major cause of premature death and disability in India and yet few people at risk of CVD are able to access best practice health care. Mobile health (mHealth) is a promising solution, but very few mHealth interventions have been subjected to robust evaluation in India. Objective: The objectives were to develop a multifaceted, mobile clinical decision support system (CDSS) for CVD management and evaluate it for use by public nonphysician health care workers (NPHWs) and physicians in a rural Indian setting. Methods: Plain language clinical rules were developed based on standard guidelines and programmed into a computer tablet app. The algorithm was validated and field-tested in 11 villages in Andhra Pradesh, involving 11 NPHWs and 3 primary health center (PHC) physicians. A mixed method evaluation was conducted comprising clinical and survey data and in-depth patient and staff interviews to understand barriers and enablers to the use of the system. Then this was thematically analyzed using NVivo 10. Results: During validation of the algorithm, there was an initial agreement for 70% of the 42 calculated variables between the CDSS and SPSS software outputs. Discrepancies were identified and amendments were made until perfect agreement was achieved. During field testing, NPHWs and PHC physicians used the CDSS to screen 227 and 65 adults, respectively. The NPHWs identified 39% (88/227) of patients for referral with 78% (69/88) of these having a definite indication for blood pressure (BP)-lowering medication. However, only 35% (24/69) attended a clinic within 1 month of referral, with 42% (10/24) of these reporting continuing medications at 3-month follow-up. Physicians identified and recommended 17% (11/65) of patients for BP-lowering medications. Qualitative interviews identified 3 interrelated interview themes: (1) the CDSS had potential to change prevailing health care models, (2) task-shifting to NPHWs was the central driver of change, and (3) despite high acceptability by end users, actual transformation was substantially limited by system-level barriers such as patient access to doctors and medicines. Conclusions: A tablet-based CDSS implemented within primary health care systems has the potential to help improve CVD outcomes in India. However, system-level barriers to accessing medical care limit its full impact. These barriers need to be actively addressed for clinical innovations to be successful. Trial Registration: Clinical Trials Registry of India: CTRI/2013/06/003753; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=6259&EncHid=51761.70513&userName=CTRI/2013/06/003753 (Archived by WebCite at http://www.webcitation.org/6UBDlrEuq). %M 25487047 %R 10.2196/mhealth.3568 %U http://mhealth.jmir.org/2014/4/e54/ %U https://doi.org/10.2196/mhealth.3568 %U http://www.ncbi.nlm.nih.gov/pubmed/25487047 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 12 %P e274 %T Reducing Alcohol Use During Pregnancy Via Health Counseling by Midwives and Internet-Based Computer-Tailored Feedback: A Cluster Randomized Trial %A van der Wulp,Nickie Y %A Hoving,Ciska %A Eijmael,Kim %A Candel,Math JJM %A van Dalen,Wim %A De Vries,Hein %+ Dutch Institute for Alcohol Policy STAP, P.O. Box 9769, Utrecht, 3506 GT, Netherlands, 31 306565041, nvanderwulp@stap.nl %K alcohol drinking %K pregnancy %K counseling %K telemedicine %K midwifery %D 2014 %7 05.12.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Effective interventions are needed to reduce neurobehavioral impairments in children due to maternal alcohol use during pregnancy. Currently, health-counseling interventions have shown inconsistent results to reduce prenatal alcohol use. Thus, more research using health counseling is needed to gain more knowledge about the effectiveness of this type of intervention on reducing alcohol use during pregnancy. An alternative and promising strategy is computer tailoring. However, to date, no study has shown the effectiveness of this intervention mode. Objective: The aim was to test the effectiveness of health counseling and computer tailoring on stopping and reducing maternal alcohol use during pregnancy in a Dutch sample of pregnant women using alcohol. Methods: A total of 60 Dutch midwifery practices, randomly assigned to 1 of 3 conditions, recruited 135 health counseling, 116 computer tailoring, and 142 usual care respondents from February to September 2011. Health-counseling respondents received counseling from their midwife according to a health-counseling protocol, which consisted of 7 steps addressed in 3 feedback sessions. Computer-tailoring respondents received usual care from their midwife and 3 computer-tailored feedback letters via the Internet. Usual care respondents received routine alcohol care from their midwife. After 3 and 6 months, we assessed the effect of the interventions on alcohol use. Results: Multilevel multiple logistic regression analyses showed that computer-tailoring respondents stopped using alcohol more often compared to usual care respondents 6 months after baseline (53/68, 78% vs 51/93, 55%; P=.04). Multilevel multiple linear regression analyses showed that computer-tailoring respondents (mean 0.35, SD 0.31 units per week) with average (P=.007) or lower (P<.001) alcohol use before pregnancy or with average (P=.03) or lower (P=.002) social support more strongly reduced their alcohol use 6 months after baseline compared to usual care respondents (mean 0.48, SD 0.54 units per week). Six months after baseline, 72% (62/86) of the health-counseling respondents had stopped using alcohol. This 17% difference with the usual care group was not significant. Conclusions: This is the first study showing that computer tailoring can be effective to reduce alcohol use during pregnancy; health counseling did not effectively reduce alcohol use. Future researchers developing a health-counseling intervention to reduce alcohol use during pregnancy are recommended to invest more in recruitment of pregnant women and implementation by health care providers. Because pregnant women are reluctant to disclose their alcohol use to health professionals and computer tailoring preserves a person’s anonymity, this effective computer-tailoring intervention is recommended as an attractive intervention for pregnant women using alcohol. Trial Registration: Dutch Trial Register NTR 2058; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2058 (Archived by WebCite at http://www.webcitation.org/6NpT1oHol) %M 25486675 %R 10.2196/jmir.3493 %U http://www.jmir.org/2014/12/e274/ %U https://doi.org/10.2196/jmir.3493 %U http://www.ncbi.nlm.nih.gov/pubmed/25486675 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 12 %P e273 %T Effectiveness of Different Web-Based Interventions to Prepare Co-Smokers of Cigarettes and Cannabis for Double Cessation: A Three-Arm Randomized Controlled Trial %A Becker,Julia %A Haug,Severin %A Sullivan,Robin %A Schaub,Michael Patrick %+ Swiss Research Institute for Public Health and Addiction ISGF, University of Zurich, Konradstrasse 32, Zurich, 8031, Switzerland, 41 444411860, julia.becker@isgf.uzh.ch %K tobacco %K cannabis %K co-smoking %K simultaneous cessation %K motivational enhancement %K personalized feedback %K web-based intervention %K motivational interviewing %D 2014 %7 05.12.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: The relationship between tobacco and cannabis use is strong. When co-smokers try to quit only one substance, this relationship often leads to a substitution effect, that is, the increased use of the remaining substance. Stopping the use of both substances simultaneously is therefore a reasonable strategy, but co-smokers rarely report feeling ready for simultaneous cessation. Thus, the question of how co-smokers can be motivated to attempt a simultaneous cessation has arisen. To reach as many co-smokers as possible, we developed brief Web-based interventions aimed at enhancing the readiness to simultaneously quit tobacco and cannabis use. Objective: Our aim was to analyze the efficacy of three different Web-based interventions designed to enhance co-smokers’ readiness to stop tobacco and cannabis use simultaneously. Methods: Within a randomized trial, three brief Web-based and fully automated interventions were compared. The first intervention combined the assessment of cigarette dependence and problematic cannabis use with personalized, normative feedback. The second intervention was based on principles of motivational interviewing. As an active psychoeducational control group, the third intervention merely provided information on tobacco, cannabis, and the co-use of the two substances. The readiness to quit tobacco and cannabis simultaneously was measured before and after the intervention (both online) and 8 weeks later (online or over the phone). Secondary outcomes included the frequency of cigarette and cannabis use, as measured at baseline and after 8 weeks. Results: A total of 2467 website users were assessed for eligibility based on their self-reported tobacco and cannabis co-use, and 325 participants were ultimately randomized and analyzed. For the post-intervention assessment, generalized estimating equations revealed a significant increase in the readiness to quit tobacco and cannabis in the total sample (B=.33, 95% CI 0.10-0.56, P=.006). However, this effect was not significant for the comparison between baseline and the 8-week follow-up assessment (P=.69). Furthermore, no differential effects between the interventions were found, nor were any significant intervention or time effects found on the frequency of tobacco or cannabis use. Conclusions: In the new field of dual interventions for co-smokers of tobacco and cannabis, Web-based interventions can increase the short-term readiness to quit tobacco and cannabis simultaneously. The studied personalized techniques were no more effective than was psychoeducation. The analyzed brief interventions did not change the secondary outcomes, that is the frequency of tobacco and cannabis use. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 56326375; http://www.isrctn.com/ISRCTN56326375 (Archived by WebCite at http://www.webcitation.org/6UUWBh8u0). %M 25486674 %R 10.2196/jmir.3246 %U http://www.jmir.org/2014/12/e273/ %U https://doi.org/10.2196/jmir.3246 %U http://www.ncbi.nlm.nih.gov/pubmed/25486674 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 12 %P e265 %T Dose-Response Effects of a Web-Based Physical Activity Program on Body Composition and Metabolic Health in Inactive Older Adults: Additional Analyses of a Randomized Controlled Trial %A Vroege,David P %A Wijsman,Carolien A %A Broekhuizen,Karen %A de Craen,Anton JM %A van Heemst,Diana %A van der Ouderaa,Frans JG %A van Mechelen,Willem %A Slagboom,P Eline %A Catt,Michael %A Westendorp,Rudi GJ %A Verhagen,Evert ALM %A Mooijaart,Simon P %+ Department of Gerontology and Geriatrics, Leiden University Medical Center, Postzone C7-Q, PO Box 9600, Leiden, 2300 RC, Netherlands, 31 715266640, S.P.Mooijaart@lumc.nl %K Internet %K physical activity %K aging %K metabolism %D 2014 %7 04.12.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Low physical activity is a major risk factor for several age-related diseases. Recently, we showed in a randomized controlled trial that a 12-week Web-based intervention (Philips DirectLife) to increase physical activity was effective in increasing physical activity levels and metabolic health in an inactive population aged 60-70 years. Objective: The goal of this paper was to assess how many participants successfully reached the physical activity level as targeted by the intervention and what the effects of the intervention on body composition and metabolic health in these successful individuals were to provide insight in the maximum attainable effect of the intervention. Methods: Among the 235 participants in a randomized controlled trial of the Actief en Gezond Oud (AGO) study, we assessed the effects of the intervention on metabolic parameters in those who had successfully reached their personalized physical activity target compared with the entire intervention group. Furthermore, we studied the dose-response effect of increase in physical activity on metabolic outcome within the intervention group. Results: Of the intervention group, 50 of 119 (42.0%) participants successfully reached the physical activity target (corresponding to a 10% increased daily physical activity on average). This group showed markedly higher effects of the intervention compared to the entire intervention group, with greater decreases in body weight (2.74 vs 1.49 kg), waist circumference (3.74 vs 2.33 cm), insulin resistance (HOMA index: 0.23 vs 0.20), and in cholesterol/HDL ratio (0.39 vs 0.20) and Framingham risk score (0.90% vs 0.54%). We found that men compared to women were more likely to be successful. The dose-response analysis showed that there was a significant association between increase in minutes spent in moderate-to-vigorous activity and body weight loss, BMI reduction, waist circumference reduction, HDL cholesterol increasing, and cholesterol/HDL ratio lowering. Conclusions: Of the intervention group, 42.0% (50/119) reached their daily physical activity end goal, which was associated with a markedly better effect on body composition and metabolic health compared to the effect in the entire intervention group. In this population, men are more likely to be successful in increasing physical activity. Findings demonstrate that improving the effect of such physical activity interventions requires finding new ways to increase the proportion of the population reaching the targeted goal. Trial Registration: Dutch Trial Registry: NTR 3045; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3045 (Archived by WebCite at http://www.webcitation.org/6KPw52dCc). %M 25486673 %R 10.2196/jmir.3643 %U http://www.jmir.org/2014/12/e265/ %U https://doi.org/10.2196/jmir.3643 %U http://www.ncbi.nlm.nih.gov/pubmed/25486673 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 4 %P e69 %T An Interactive Health Communication Application for Supporting Parents Managing Childhood Long-Term Conditions: Outcomes of a Randomized Controlled Feasibility Trial %A Swallow,Veronica M %A Knafl,Kathleen %A Santacroce,Sheila %A Campbell,Malcolm %A Hall,Andrew G %A Smith,Trish %A Carolan,Ian %+ School of Nursing, Midwifery and Social Work, Faculty of Medical and Human Sciences, University of Manchester, Oxford Road, Manchester, M13 9PL, United Kingdom, 44 1613066000, veronica.swallow@manchester.ac.uk %K child %K chronic condition %K chronic kidney disease, CKD %K family %K feasibility %K interactive health communication application %K online %K long-term condition %K parent %K randomized controlled trial %D 2014 %7 03.12.2014 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Families living with chronic or long-term conditions such as chronic kidney disease (CKD), stages 3-5, face multiple challenges and respond to these challenges in various ways. Some families adapt well while others struggle, and family response to a condition is closely related to outcome. With families and professionals, we developed a novel condition-specific interactive health communication app to improve parents’ management ability—the online parent information and support (OPIS) program. OPIS consists of a comprehensive mix of clinical caregiving and psychosocial information and support. Objective: The purpose of this study was to (1) assess feasibility of a future full-scale randomized controlled trial (RCT) of OPIS in terms of recruitment and retention, data collection procedures, and psychometric performance of the study measures in the target population, and (2) investigate trends in change in outcome measures in a small-scale RCT in parents of children with CKD stages 3-5. Methods: Parents were recruited from a pediatric nephrology clinic and randomly assigned to one of two treatment groups: usual support for home-based clinical caregiving (control) or usual support plus password-protected access to OPIS for 20 weeks (intervention). Both groups completed study measures at study entry and exit. We assessed feasibility descriptively in terms of recruitment and retention rates overall; assessed recruitment, retention, and uptake of the intervention between groups; and compared family condition management, empowerment to deliver care, and fathers’ involvement between groups. Results: We recruited 55 parents of 39 children (42% of eligible families). Of those, about three-quarters of intervention group parents (19/26, 73%) and control group parents (22/29, 76%) were retained through completion of 20-week data collection. The overall retention rate was 41/55 (75%). The 41 parents completing the trial were asked to respond to the same 10 questionnaire scales at both baseline and 20 weeks later; 10 scores were missing at baseline and nine were missing at 20 weeks. Site user statistics provided evidence that all intervention group parents accessed OPIS. Analysis found that intervention group parents showed a greater improvement in perceived competence to manage their child’s condition compared to control group parents: adjusted mean Family Management Measure (FaMM) Condition Management Ability Scale intervention group 44.5 versus control group 41.9, difference 2.6, 95% CI -1.6 to 6.7. Differences between the groups in the FaMM Family Life Difficulty Scale (39.9 vs 36.3, difference 3.7, 95% CI -4.9 to 12.2) appeared to agree with a qualitative observation that OPIS helped parents achieve understanding and maintain awareness of the impact of their child’s condition. Conclusions: A full-scale RCT of the effectiveness of OPIS is feasible. OPIS has the potential to beneficially affect self-reported outcomes, including parents’ perceived competence to manage home-based clinical care for children with CKD stage 3-5. Our design and methodology can be transferred to the management of other childhood conditions. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 84283190; http://www.controlled-trials.com/ISRCTN84283190 (Archived by WebCite at http://www.webcitation.org/6TuPdrXTF). %M 25472567 %R 10.2196/resprot.3716 %U http://www.researchprotocols.org/2014/4/e69/ %U https://doi.org/10.2196/resprot.3716 %U http://www.ncbi.nlm.nih.gov/pubmed/25472567 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 4 %P e70 %T A Web-Based Training Program Using Cognitive Behavioral Therapy to Alleviate Psychological Distress Among Employees: Randomized Controlled Pilot Trial %A Mori,Makiko %A Tajima,Miyuki %A Kimura,Risa %A Sasaki,Norio %A Somemura,Hironori %A Ito,Yukio %A Okanoya,June %A Yamamoto,Megumi %A Nakamura,Saki %A Tanaka,Katsutoshi %+ Department of Occupational Mental Health, Graduate School of Medical Sciences, Kitasato University, 1-15-1, Kitasato, Sagamihara-City Kanagawa, 228-8555, Japan, 81 042 660 9119, makiko.mori@konicaminolta.com %K Web-based training program %K cognitive behavioral therapy %K stress management %K workplace %K Internet %K group %D 2014 %7 02.12.2014 %9 Original Paper %J JMIR Res Protoc %G English %X Background: A number of psychoeducational programs based on cognitive behavioral therapy (CBT) to alleviate psychological distress have been developed for implementation in clinical settings. However, while these programs are considered critical components of stress management education in a workplace setting, they are required to be brief and simple to implement, which can hinder development. Objective: The intent of the study was to examine the effects of a brief training program based on CBT in alleviating psychological distress among employees and facilitating self-evaluation of stress management skills, including improving the ability to recognize dysfunctional thinking patterns, transform dysfunctional thoughts to functional ones, cope with stress, and solve problems. Methods: Of the 187 employees at an information technology company in Tokyo, Japan, 168 consented to participate in our non-blinded randomized controlled study. The training group received CBT group education by a qualified CBT expert and 1 month of follow-up Web-based CBT homework. The effects of this educational program on the psychological distress and stress management skills of employees were examined immediately after completion of training and then again after 6 months. Results: Although the training group did exhibit lower mean scores on the Kessler-6 (K6) scale for psychological distress after 6 months, the difference from the control group was not significant. However, the ability of training group participants to recognize dysfunctional thinking was significantly improved both immediately after training completion and after 6 months. While the ability of participants to cope with stress was not significantly improved immediately after training, improvement was noted after 6 months in the training group. No notable improvements were observed in the ability of participants to transform thoughts from dysfunctional to functional or in problem-solving skills. A sub-analysis of participants who initially exhibited clinically significant psychological distress (K6 score ≥5) showed that the mean K6 score was significantly improved immediately after training completion for the training group compared to the control group (−2.50 vs −0.07; mean difference 2.43, 95% CI 0.55-4.31; d=0.61), with this effect remaining even after 6 months (−3.49 vs −0.50; mean difference 2.99, 95% CI 0.70-5.29; d=0.60). Conclusions: Our results suggest that a brief stress management program that combines group CBT education with Web-based CBT homework moderately alleviates the distress of employees with clinically significant psychological distress. In addition, the program might help improve employees’ ability to evaluate their own stress management skills. %M 25470499 %R 10.2196/resprot.3629 %U http://www.researchprotocols.org/2014/4/e70/ %U https://doi.org/10.2196/resprot.3629 %U http://www.ncbi.nlm.nih.gov/pubmed/25470499 %0 Journal Article %@ 2368-7959 %I JMIR Publications Inc. %V 1 %N 1 %P e2 %T Implementation and Outcomes of a Collaborative Multi-Center Network Aimed at Web-Based Cognitive Training – COGWEB Network %A Tedim Cruz,Vítor %A Pais,Joana %A Ruano,Luis %A Mateus,Cátia %A Colunas,Márcio %A Alves,Ivânia %A Barreto,Rui %A Conde,Eduardo %A Sousa,Andreia %A Araújo,Isabel %A Bento,Virgílio %A Coutinho,Paula %A Rocha,Nelson %A , %+ Hospital São Sebastião, Centro Hospitalar Entre Douro e Vouga, Neurology Department, Rua Dr. Cândido de Pinho, Santa Maria da Feira, 4520-211, Portugal, 351 936173516, vitor.cruz@chedv.min-saude.pt %K cognitive training %K neurorehabilitation %K eHealth systems %K memory clinic %K collaborative network %K stroke %K dementia %K schizophrenia %K mental health services %D 2014 %7 27.11.2014 %9 Original Paper %J JMIR Mental Health %G English %X Background: Cognitive care for the most prevalent neurologic and psychiatric conditions will only improve through the implementation of new sustainable approaches. Innovative cognitive training methodologies and collaborative professional networks are necessary evolutions in the mental health sector. Objective: The objective of the study was to describe the implementation process and early outcomes of a nationwide multi-organizational network supported on a Web-based cognitive training system (COGWEB). Methods: The setting for network implementation was the Portuguese mental health system and the hospital-, academic-, community-based institutions and professionals providing cognitive training. The network started in August 2012, with 16 centers, and was monitored until September 2013 (inclusions were open). After onsite training, all were allowed to use COGWEB in their clinical or research activities. For supervision and maintenance were implemented newsletters, questionnaires, visits and webinars. The following outcomes were prospectively measured: (1) number, (2) type, (3) time to start, and (4) activity state of centers; age, gender, level of education, and medical diagnosis of patients enrolled. Results: The network included 68 professionals from 41 centers, (33/41) 80% clinical, (8/41) 19% nonclinical. A total of 298 patients received cognitive training; 45.3% (n=135) female, mean age 54.4 years (SD 18.7), mean educational level 9.8 years (SD 4.8). The number enrolled each month increased significantly (r=0.6; P=.031). At 12 months, 205 remained on treatment. The major causes of cognitive impairment were: (1) neurodegenerative (115/298, 38.6%), (2) structural brain lesions (63/298, 21.1%), (3) autoimmune (40/298, 13.4%), (4) schizophrenia (30/298, 10.1%), and (5) others (50/298, 16.8%). The comparison of the patient profiles, promoter versus all other clinical centers, showed significant increases in the diversity of causes and spectrums of ages and education. Conclusions: Over its first year, there was a major increase in the number of new centers and professionals, as well as of the clinical diversity of patients treated. The consolidation of such a national collaborative network represents an innovative step in mental health care evolution. Furthermore, it may contribute to translational processes in the field of cognitive training and reduce disease burden. %M 26543902 %R 10.2196/mental.3840 %U http://www.jmir.org/2014/1/e2/ %U https://doi.org/10.2196/mental.3840 %U http://www.ncbi.nlm.nih.gov/pubmed/26543902 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 4 %P e63 %T Acceptability of a Web-Based and Tailored Intervention for the Self-Management of Pain After Cardiac Surgery: The Perception of Women and Men %A Martorella,Geraldine %A Gélinas,Céline %A Purden,Margaret %+ Faculty of Nursing, University of Montreal, C.P. 6128, succursale Centre-Ville, Montreal, QC, H3C3J7, Canada, 1 5143436111 ext 1000, geraldine.martorella@umontreal.ca %K pain, postoperative %K surgery, cardiac %K patient education %K Internet %K mixed method %D 2014 %7 20.11.2014 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Approximately two thirds of adults undergoing cardiac surgery suffer from moderate to severe postoperative pain. Assisting patients with pain management is therefore critical to prevent its negative consequences. Information technologies have become part of our lifestyle and can facilitate the implementation of interventions to manage pain in a busy care setting. A computer-tailored and Web-based intervention—referred to as SOUtien à L’AutoGEstion-Traitement-Assistance Virtuelle Infirmière-Enseignement (SOULAGE-TAVIE)—for the self-management of pain was developed. Findings from a previous pilot randomized controlled trial (RCT) provided some evidence of the feasibility and preliminary effectiveness of this intervention in decreasing pain interference with a few postoperative activities and by modulating pain beliefs and analgesic intake. However, its acceptability from the patient’s perspective remains unclear. Moreover, the proportion of women is much lower in the cardiac surgical population, making it difficult to detect differences in experiences between men and women. Objective: The objectives were (1) to describe SOULAGE-TAVIE’s acceptability from the perspective of adults experiencing pain after cardiac surgery and (2) to compare the perceptions of men and women. Methods: A mixed-method approach was used to capture the various attributes of patients’ perceptions of the intervention’s acceptability and to compare the perceptions of men and women. Quota samples of men (n=10; mean age 62.5 years, SD 7.3) and women (n=10; mean age 64.3 years, SD 10.7) who had cardiac surgery in the past month were invited to view the intervention, complete a brief questionnaire rating its acceptability, and then to discuss each component in a 60-minute, semistructured interview. Mann-Whitney U tests were used to compare groups. The transcripts were content analyzed to generate themes based on patients’ experiences with the intervention and reports of acceptability. The content of each category and subcategory were compared between men and women. Frequency counts were also done to validate the emergence of a difference between the 2 subgroups. Results: Participants perceived the intervention to be very acceptable in terms of content and format, and tended to describe awareness-raising and convenient support experiences. Women scored higher than men in terms of the intervention’s appropriateness (U=13.5, P=.008). They were willing to adhere to the intervention based on the importance and relevance of the advice provided, whereas men were more focused on the delivery mode and its flexibility. Conclusions: This study underlined the acceptability of computer tailoring and persuasive communication to modulate pain beliefs and attitudes in an acute care context. Both men and women appreciated the Web-based interface and general self-guided approach of the intervention. The delivery of SOULAGE-TAVIE across the continuum of care seems to be an interesting avenue to influence the transition from acute to chronic postoperative pain. %M 25487135 %R 10.2196/resprot.3175 %U http://www.researchprotocols.org/2014/4/e63/ %U https://doi.org/10.2196/resprot.3175 %U http://www.ncbi.nlm.nih.gov/pubmed/25487135 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 11 %P e255 %T Web-Enhanced Tobacco Tactics With Telephone Support Versus 1-800-QUIT-NOW Telephone Line Intervention for Operating Engineers: Randomized Controlled Trial %A Choi,Seung Hee %A Waltje,Andrea H %A Ronis,David L %A Noonan,Devon %A Hong,OiSaeng %A Richardson,Caroline R %A Meeker,John D %A Duffy,Sonia A %+ University of Michigan, School of Nursing, 400 N. Ingalls Building #3178, Ann Arbor, MI, 48109, United States, 1 734 395 0613, bump@umich.edu %K smoking cessation %K intervention study %K workplace %K blue collar workers %D 2014 %7 20.11.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Novel interventions tailored to blue collar workers are needed to reduce the disparities in smoking rates among occupational groups. Objective: The main objective of this study was to evaluate the efficacy and usage of the Web-enhanced “Tobacco Tactics” intervention targeting operating engineers (heavy equipment operators) compared to the “1-800-QUIT-NOW” telephone line. Methods: Operating engineers (N=145) attending one of 25 safety training sessions from 2010 through 2012 were randomized to either the Tobacco Tactics website with nurse counseling by phone and access to nicotine replacement therapy (NRT) or to the 1-800-QUIT-NOW telephone line, which provided an equal number of phone calls and NRT. The primary outcome was self-reported 7-day abstinence at 30-day and 6-month follow-up. The outcomes were compared using chi-square tests, t tests, generalized mixed models, and logistic regression models. Results: The average age was 42 years and most were male (115/145, 79.3%) and white (125/145, 86.2%). Using an intent-to-treat analysis, the Tobacco Tactics website group showed significantly higher quit rates (18/67, 27%) than the 1-800-QUIT NOW group (6/78, 8%) at 30-day follow-up (P=.003), but this difference was no longer significant at 6-month follow-up. There were significantly more positive changes in harm reduction measures (quit attempts, number of cigarettes smoked per day, and nicotine dependence) at both 30-day and 6-month follow-up in the Tobacco Tactics group compared to the 1-800-QUIT-NOW group. Compared to participants in the 1-800-QUIT NOW group, significantly more of those in the Tobacco Tactics website group participated in the interventions, received phone calls and NRT, and found the intervention helpful. Conclusions: The Web-enhanced Tobacco Tactics website with telephone support showed higher efficacy and reach than the 1-800-QUIT-NOW intervention. Longer counseling sessions may be needed to improve 6-month cessation rates. Trial Registration: Clinicaltrials.gov NCT01124110; http://clinicaltrials.gov/ct2/show/NCT01124110 (Archived by WebCite at http://www.webcitation.org/6TfKN5iNL). %M 25447467 %R 10.2196/jmir.3375 %U http://www.jmir.org/2014/11/e255/ %U https://doi.org/10.2196/jmir.3375 %U http://www.ncbi.nlm.nih.gov/pubmed/25447467 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 11 %P e252 %T Analyzing Engagement in a Web-Based Intervention Platform Through Visualizing Log-Data %A Morrison,Cecily %A Doherty,Gavin %+ Microsoft Research, 21 Station Rd, Cambridge, CB1 2FB, United Kingdom, 44 1223 479 951, cpm38@cam.ac.uk %K engagement %K log-data analysis %K data visualisation %K Web-based interventions %D 2014 %7 13.11.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Engagement has emerged as a significant cross-cutting concern within the development of Web-based interventions. There have been calls to institute a more rigorous approach to the design of Web-based interventions, to increase both the quantity and quality of engagement. One approach would be to use log-data to better understand the process of engagement and patterns of use. However, an important challenge lies in organizing log-data for productive analysis. Objective: Our aim was to conduct an initial exploration of the use of visualizations of log-data to enhance understanding of engagement with Web-based interventions. Methods: We applied exploratory sequential data analysis to highlight sequential aspects of the log data, such as time or module number, to provide insights into engagement. After applying a number of processing steps, a range of visualizations were generated from the log-data. We then examined the usefulness of these visualizations for understanding the engagement of individual users and the engagement of cohorts of users. The visualizations created are illustrated with two datasets drawn from studies using the SilverCloud Platform: (1) a small, detailed dataset with interviews (n=19) and (2) a large dataset (n=326) with 44,838 logged events. Results: We present four exploratory visualizations of user engagement with a Web-based intervention, including Navigation Graph, Stripe Graph, Start–Finish Graph, and Next Action Heat Map. The first represents individual usage and the last three, specific aspects of cohort usage. We provide examples of each with a discussion of salient features. Conclusions: Log-data analysis through data visualization is an alternative way of exploring user engagement with Web-based interventions, which can yield different insights than more commonly used summative measures. We describe how understanding the process of engagement through visualizations can support the development and evaluation of Web-based interventions. Specifically, we show how visualizations can (1) allow inspection of content or feature usage in a temporal relationship to the overall program at different levels of granularity, (2) detect different patterns of use to consider personalization in the design process, (3) detect usability issues, (4) enable exploratory analysis to support the design of statistical queries to summarize the data, (5) provide new opportunities for real-time evaluation, and (6) examine assumptions about interactivity that underlie many summative measures in this field. %M 25406097 %R 10.2196/jmir.3575 %U http://www.jmir.org/2014/11/e252/ %U https://doi.org/10.2196/jmir.3575 %U http://www.ncbi.nlm.nih.gov/pubmed/25406097 %0 Journal Article %@ 1923-2195 %I Gunther Eysenbach %V 3 %N 2 %P e5 %T The Diabetes App Challenge: User-Led Development and Piloting of Internet Applications Enabling Young People With Diabetes to Set the Focus for Their Diabetes Consultations %A Ashurst,Emily J %A Jones,Ray B %A Abraham,Charles %A Jenner,Martin %A Boddy,Kate %A Besser,Rachel EJ %A Hammersley,Suzanne %A Pinkney,Jonathan %+ Plymouth University, School of Nursing and Midwifery, 3 Portland Villas, Plymouth, PL4 8AA, United Kingdom, 44 1752661577, ray.jones@plymouth.ac.uk %K Type 1 diabetes %K adolescents %K mobile technology %K clinic appointment %K user-innovation %K self-care %K user-centered design %D 2014 %7 07.11.2014 %9 Original Paper %J Med 2.0 %G English %X Background: Traditionally, some teenagers and young adults with diabetes have not engaged well at diabetes appointments, giving rise to concerns about long-term health risks. We considered that apps might help this group of patients to improve preparation for, and therefore engagement at their appointments. Although there are already many apps for young people with type 1 diabetes (YPD), we thought that by supporting YPD themselves to develop apps, the resulting products would have greater “authenticity” and relevance. Objective: To test the feasibility of an online competition to (1) recruit and support YPD to develop apps (mobile or Internet based) to help prepare for clinic appointments, and (2) for these apps to be tested and rated by YPD. Methods: The “Diabetes App Challenge” was a United Kingdom (UK) national competition, run between June and October 2012 for teams including at least one YPD (aged 16-25) to pilot the design and development of apps for use by other YPD prior to clinic appointments. The competition was advertised by social media, email, AdWords and postings on the Diabetes UK website. Registrants for the competition were supported via email and discussion forum. After app development, other YPD were invited (November 2012-February 2013) to trial the apps, choose and use one prior to a clinic appointment, and review their experiences. Results: Of 56 people (including 28 YPD) who expressed interest in the competition, 6 teams (14 people) developed and submitted an app. Two apps aimed to facilitate agenda setting in clinic consultations, 2 enabled data logging and 2 helped insulin dose calculation. Of 135 YPD who registered to trial the apps, 83 (61.5%) took part (mean age 18.98, 37/83 male). Agenda setting apps were considered most useful for preparing for and setting the focus of clinic appointments (P=.02). Just over half (46/83, 55%) said they would use their chosen app again and 4/5 (67/83, 81%) would recommend it to a friend. Conclusions: This competition to engage YPD in developing and reviewing apps proved successful. App designers and testers saw a need for a range of functions. However, this may, in part, reflect a lack of detailed knowledge of all existing apps and be limited by the technical skills of YPD. App competitions appear worth applying to other patient groups, but future competitions should include a review stage and perhaps focus on ideas for app design for subsequent professional implementation. %M 25654312 %R 10.2196/med20.3032 %U http://www.medicine20.com/2014/2/e5/ %U https://doi.org/10.2196/med20.3032 %U http://www.ncbi.nlm.nih.gov/pubmed/25654312 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 4 %P e59 %T Active Patient Participation in the Development of an Online Intervention %A van Bruinessen,Inge Renske %A van Weel-Baumgarten,Evelyn M %A Snippe,Harm Wouter %A Gouw,Hans %A Zijlstra,Josée M %A van Dulmen,Sandra %+ NIVEL (Netherlands Institute for Health Services Research), Otterstraat 118-124, Utrecht, 3500bn, Netherlands, 31 302729680, i.vanbruinessen@nivel.nl %K communication %K malignant lymphoma %K online intervention %K self-help application %K patient participation %K intervention development %D 2014 %7 06.11.2014 %9 Original Paper %J JMIR Res Protoc %G English %X Background: An important and challenging part of living with cancer relates to the repeated visits to the hospital. Since how patients cope between these post-diagnostic visits depends partly on the information and support received from their physician during the visits, it is important to make the most of them. Recent findings reinforce the importance of training not only the health care professionals in communication skills, but providing patients with support in communication as well. Delivering such supportive interventions online can have potential benefits in terms of accessibility, cost-effectiveness, and ability to tailor information to personal needs. However, problems with attrition (dropout, non-usage) during the test phase and poor uptake after implementation are frequently reported. The marginal level of engagement of the patient as end user seems to play a role in this. Therefore, recent research suggests integrating theory-based development methods with methods that promote involvement of the patient at an early stage. This paper describes a participatory protocol, used to let patients guide a theory-informed development process. Objective: The objective of this project was to apply a bottom-up inspired procedure to develop a patient-centered intervention with corresponding evaluation and implementation plan. Methods: The applied development protocol was based on the intervention mapping framework, combined with patient participatory methods that were inspired by the participation ladder and user-centred design methods. Results: The applied protocol led to a self-directed online communication intervention aimed at helping patients gain control during their communications with health care professionals. It also led to an evaluation plan and an implementation plan. The protocol enabled the continuous involvement of patient research partners and the partial involvement of patient service users, which led to valuable insights and improvements. Conclusions: The applied protocol realized patient participation on different levels throughout the entire project. Early involvement, involvement on different levels, and flexibility in terms of planning and setup seem to be preconditions to creating a bottom-up inspired development procedure with (seriously ill) patients. Further research is necessary to find out if a more patient-centered approach improves the implementation and uptake of eHealth interventions. Trial Registration: Netherlands National Trial Register ID number: NTR3779; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3779 (Archived by WebCite at http://www.webcitation.org/6TdfALKxV). %M 25379679 %R 10.2196/resprot.3695 %U http://www.researchprotocols.org/2014/4/e59/ %U https://doi.org/10.2196/resprot.3695 %U http://www.ncbi.nlm.nih.gov/pubmed/25379679 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 11 %P e234 %T The Change in Eating Behaviors in a Web-Based Weight Loss Program: A Longitudinal Analysis of Study Completers %A Svensson,Madeleine %A Hult,Mari %A van der Mark,Marianne %A Grotta,Alessandra %A Jonasson,Josefine %A von Hausswolff-Juhlin,Yvonne %A Rössner,Stephan %A Trolle Lagerros,Ylva %+ Halmstad University, Deparment of Health and Social Sciences, Center of research on Welfare Health and Sport, Box 823, Halmstad, SE-30118, Sweden, 46 35167100, Madeleine.Svensson@hh.se %K behavior %K counseling %K diet %K eating %K method %K questionnaires %K Internet %K weight loss %K TFEQ %D 2014 %7 03.11.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Eating behaviors are essential components in weight loss programs, but limited research has explored eating behaviors in Web-based weight loss programs. Objectives: The aim was to evaluate an interactive Web-based weight loss program on eating behaviors using the 18-item Three-Factor Eating Questionnaire Revised (TFEQ-R18) which measures uncontrolled eating, emotional eating, and cognitive restrained eating. Our Web-based weight loss program is comprised of information about healthy lifestyle choices, weekly chats with experts, social networking features, databases for recipe searches, and features allowing members to self-report and track their weight, physical activity, and dietary intake on the website. Methods: On registering for the weight loss program, 23,333 members agreed to take part in the research study. The participants were then asked to complete the TFEQ-R18 questionnaire at baseline and after 3 and 6 months of participation. All data collection was conducted online, with no face-to-face contact. To study changes in TFEQ-R18 eating behaviors we restricted our study to those members who completed all 3 TFEQ-R18 questionnaires. These participants were defined as “completers” and the remaining as “noncompleters.” The relationships between sex, change in eating behaviors, and total weight loss were studied using repeated measures ANOVA and Pearson correlation coefficient. Results: In total, 22,800 individuals participated (females: 19,065/22,800, 83.62%; mean age 39.6, SD 11.4 years; BMI 29.0 kg/m2; males: 3735/22,800, 16.38%; mean age 43.2, SD 11.7 years; BMI 30.8 kg/m2). Noncompleters (n=22,180) were younger and reported a lower score of uncontrolled eating and a higher score of cognitive restrained eating. Over time, completers (n=620) decreased their uncontrolled eating score (from 56.3 to 32.0; P<.001) and increased their cognitive restrained eating (from 50.6 to 62.9; P<.001). Males decreased their emotional eating (from 57.2 to 35.9; P<.001), but no significant change was found among females. The baseline cognitive restrained eating score was significantly and positively associated with weight loss for completers in both men (P=.02) and women (P=.002). Conclusions: To our knowledge, this is the largest TFEQ sample that has been documented. This Web-based weight loss intervention suggests that eating behaviors (cognitive restrained eating, uncontrolled eating, and emotional eating) measured by TFEQ-R18 were significantly changed during 6 months of participation. Our findings indicate differences in eating behaviors with respect to sex, but should be interpreted with caution because attrition was high. %M 25367316 %R 10.2196/jmir.3131 %U http://www.jmir.org/2014/11/e234/ %U https://doi.org/10.2196/jmir.3131 %U http://www.ncbi.nlm.nih.gov/pubmed/25367316 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 10 %P e242 %T Evaluating the Interactive Web-Based Program, Activate Your Heart, for Cardiac Rehabilitation Patients: A Pilot Study %A Brough,Christopher %A Boyce,Sally %A Houchen-Wolloff,Linzy %A Sewell,Louise %A Singh,Sally %+ Centre for Exercise and Rehabilitation Science, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Groby Road, Leicester, LE3 9QP, United Kingdom, 44 01162502760, christopher.brough@uhl-tr.nhs.uk %K Activate Your Heart %K coronary heart disease %K cardiac rehabilitation %K Internet %K Web-based %D 2014 %7 29.10.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Conventional cardiac rehabilitation (CR) programs are traditionally based on time-constrained, structured, group-based programs, usually set in hospitals or leisure centers. Uptake for CR remains poor, despite the ongoing evidence demonstrating its benefits. Additional alternative forms of CR are needed. An Internet-based approach may offer an alternative mode of delivering CR that may improve overall uptake. Activate Your Heart (AYH) is a Web-based CR program that has been designed to support individuals with coronary heart disease (CHD). Objective: The aim of this pilot study was to observe the outcome for participants following the AYH program. Methods: We conducted a prospective observational trial, recruiting low-risk patients with CHD. Measures of exercise, exercise capacity, using the Incremental Shuttle Walk Test (ISWT), dietary habits, and psychosocial well-being were conducted by a CR specialist at baseline and at 8 weeks following the Web-based intervention. Results: We recruited 41 participants; 33 completed the program. We documented significant improvements in the ISWT distance (mean change 49.69 meters, SD 68.8, P<.001), and Quality of Life (QOL) (mean change 0.28, SD 0.4, P<.001). Dietary habits improved with an increased proportion of patients consuming at least 5 portions of fruit and vegetables per day, (22 [71%] to 29 [94%] P=.01) and an increased proportion of patients consuming at least 2 portions of oily fish per week (14 [45%] to 21 [68%], P=.01). We did not detect changes in anxiety and depression scores or exercise behavior. Conclusions: We observed important improvements in exercise capacity, QOL, and dietary habits in a group of participants following a Web-based CR program. The program may offer an alternative approach to CR. A mobile version has been developed and we need to conduct further trials to establish its value compared to supervised CR. %M 25359204 %R 10.2196/jmir.3027 %U http://www.jmir.org/2014/10/e242/ %U https://doi.org/10.2196/jmir.3027 %U http://www.ncbi.nlm.nih.gov/pubmed/25359204 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 10 %P e235 %T Diabetes Patients' Experiences With the Implementation of Insulin Therapy and Their Perceptions of Computer-Assisted Self-Management Systems for Insulin Therapy %A Simon,Airin CR %A Gude,Wouter T %A Holleman,Frits %A Hoekstra,Joost BL %A Peek,Niels %+ University of Amsterdam/Academic Medical Center, Internal Medicine/Medical Informatics, Rm F4-215, Meibergdreef 9, Amsterdam, 1105 AZ, Netherlands, 31 205668136, a.c.simon@amc.uva.nl %K Type 2 diabetes mellitus %K clinical decision support systems %K patient acceptance of health care %D 2014 %7 23.10.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Computer-assisted decision support is an emerging modality to assist patients with type 2 diabetes mellitus (T2DM) in insulin self-titration (ie, self-adjusting insulin dose according to daily blood glucose levels). Computer-assisted insulin self-titration systems mainly focus on helping patients overcome barriers related to the cognitive components of insulin titration. Yet other (eg, psychological or physical) barriers could still impede effective use of such systems. Objective: Our primary aim was to identify experiences with and barriers to self-monitoring of blood glucose, insulin injection, and insulin titration among patients with T2DM. Our research team developed a computer-assisted insulin self-titration system, called PANDIT. The secondary aim of this study was to evaluate patients’ perceptions of computer-assisted insulin self-titration. We included patients who used PANDIT in a 4-week pilot study as well as patients who had never used such a system. Methods: In-depth, semi-structured interviews were conducted individually with patients on insulin therapy who were randomly recruited from a university hospital and surrounding general practices in the Netherlands. The interviews were transcribed verbatim and analyzed qualitatively. To classify the textual remarks, we created a codebook during the analysis, in a bottom-up and iterative fashion. To support examination of the final coded data, we used three theories from the field of health psychology and the integrated model of user satisfaction and technology acceptance by Wixom and Todd. Results: When starting insulin therapy, some patients feared a lifelong commitment to insulin therapy and disease progression. Also, many barriers arose when implementing insulin therapy (eg, some patients were embarrassed to inject insulin in public). Furthermore, patients had difficulties increasing the insulin dose because they fear hypoglycemia, they associate higher insulin doses with disease progression, and some were ignorant of treatment targets. Patients who never used a computer-assisted insulin self-titration system felt they had enough knowledge to know when their insulin should be adjusted, but still believed that the system advice would be useful to confirm their reasoning. Furthermore, the time and effort saved with automated insulin advice was considered an advantage. Patients who had used PANDIT found the system useful if their glycemic regulation improved. Nevertheless, for some patients, the absence of personal contact with their caregiver was a drawback. While guidelines state that adjustment of basal insulin dose based on fasting plasma glucose values is sufficient, both patients who had and those who had not used PANDIT felt that such a system should take more patient data into consideration, such as lifestyle and diet factors. Conclusions: Patients encounter multiple obstacles when implementing insulin therapy. Computer-assisted insulin self-titration can increase patient awareness of treatment targets and increase their confidence in self-adjusting the insulin dose. Nevertheless, some barriers may still exist when using computer-assisted titration systems and these systems could also introduce new barriers. %M 25340869 %R 10.2196/jmir.3198 %U http://www.jmir.org/2014/10/e235/ %U https://doi.org/10.2196/jmir.3198 %U http://www.ncbi.nlm.nih.gov/pubmed/25340869 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 10 %P e201 %T Understanding Usage of a Hybrid Website and Smartphone App for Weight Management: A Mixed-Methods Study %A Morrison,Leanne G %A Hargood,Charlie %A Lin,Sharon Xiaowen %A Dennison,Laura %A Joseph,Judith %A Hughes,Stephanie %A Michaelides,Danius T %A Johnston,Derek %A Johnston,Marie %A Michie,Susan %A Little,Paul %A Smith,Peter WF %A Weal,Mark J %A Yardley,Lucy %+ Centre for Applications of Health Psychology, Academic Unit of Psychology, University of Southampton, Highfield Campus, Highfield, Southampton, SO17 1BJ, United Kingdom, 44 2380597222 ext 7222, l.morrison@soton.ac.uk %K qualitative research %K weight loss %K behavioral research %K mobile apps %K Internet %K health %K program acceptability %K behavior %K mixed-methods %D 2014 %7 22.10.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Advancements in mobile phone technology offer huge potential for enhancing the timely delivery of health behavior change interventions. The development of smartphone-based health interventions (apps) is a rapidly growing field of research, yet there have been few longitudinal examinations of how people experience and use these apps within their day-to-day routines, particularly within the context of a hybrid Web- and app-based intervention. Objective: This study used an in-depth mixed-methods design to examine individual variation in (1) impact on self-reported goal engagement (ie, motivation, self-efficacy, awareness, effort, achievement) of access to a weight management app (POWeR Tracker) when provided alongside a Web-based weight management intervention (POWeR) and (2) usage and views of POWeR Tracker. Methods: Thirteen adults were provided access to POWeR and were monitored over a 4-week period. Access to POWeR Tracker was provided in 2 alternate weeks (ie, weeks 1 and 3 or weeks 2 and 4). Participants’ goal engagement was measured daily via self-report. Mixed effects models were used to examine change in goal engagement between the weeks when POWeR Tracker was and was not available and whether the extent of change in goal engagement varied between individual participants. Usage of POWeR and POWeR Tracker was automatically recorded for each participant. Telephone interviews were conducted and analyzed using inductive thematic analysis to further explore participants’ experiences using POWeR and POWeR Tracker. Results: Access to POWeR Tracker was associated with a significant increase in participants’ awareness of their eating (β1=0.31, P=.04) and physical activity goals (β1=0.28, P=.03). The level of increase varied between individual participants. Usage data showed that participants used the POWeR website for similar amounts of time during the weeks when POWeR Tracker was (mean 29 minutes, SD 31 minutes) and was not available (mean 27 minutes, SD 33 minutes). POWeR Tracker was mostly accessed in short bursts (mean 3 minutes, SD 2 minutes) during convenient moments or moments when participants deemed the intervention content most relevant. The qualitative data indicated that nearly all participants agreed that it was more convenient to access information on-the-go via their mobiles compared to a computer. However, participants varied in their views and usage of the Web- versus app-based components and the informational versus tracking tools provided by POWeR Tracker. Conclusions: This study provides evidence that smartphones have the potential to improve individuals’ engagement with their health-related goals when used as a supplement to an existing online intervention. The perceived convenience of mobile access to information does not appear to deter use of Web-based interventions or strengthen the impact of app access on goal engagement. A mixed-methods design enabled exploration of individual variation in daily usage of the app-based tools. %M 25355131 %R 10.2196/jmir.3579 %U http://www.jmir.org/2014/10/e201/ %U https://doi.org/10.2196/jmir.3579 %U http://www.ncbi.nlm.nih.gov/pubmed/25355131 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 10 %P e211 %T Supporting Health Care Professionals to Improve the Processes of Shared Decision Making and Self-Management in a Web-Based Intervention: Randomized Controlled Trial %A Sassen,Barbara %A Kok,Gerjo %A Schepers,Jan %A Vanhees,Luc %+ Faculty of Health Care, Innovation in Health Care, University of Applied Sciences, Bolognalaan 101, Utrecht, 3584 CJ, Netherlands, 31 300884815032, Barbara.sassen@hu.nl %K Web-based intervention %K health professionals %K RCT %K self-management %K barriers %D 2014 %7 21.10.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Research to assess the effect of interventions to improve the processes of shared decision making and self-management directed at health care professionals is limited. Using the protocol of Intervention Mapping, a Web-based intervention directed at health care professionals was developed to complement and optimize health services in patient-centered care. Objective: The objective of the Web-based intervention was to increase health care professionals’ intention and encouraging behavior toward patient self-management, following cardiovascular risk management guidelines. Methods: A randomized controlled trial was used to assess the effect of a theory-based intervention, using a pre-test and post-test design. The intervention website consisted of a module to help improve professionals’ behavior, a module to increase patients’ intention and risk-reduction behavior toward cardiovascular risk, and a parallel module with a support system for the health care professionals. Health care professionals (n=69) were recruited online and randomly allocated to the intervention group (n=26) or (waiting list) control group (n=43), and invited their patients to participate. The outcome was improved professional behavior toward health education, and was self-assessed through questionnaires based on the Theory of Planned Behavior. Social-cognitive determinants, intention and behavior were measured pre-intervention and at 1-year follow-up. Results: The module to improve professionals’ behavior was used by 45% (19/42) of the health care professionals in the intervention group. The module to support the health professional in encouraging behavior toward patients was used by 48% (20/42). The module to improve patients’ risk-reduction behavior was provided to 44% (24/54) of patients. In 1 of every 5 patients, the guideline for cardiovascular risk management was used. The Web-based intervention was poorly used. In the intervention group, no differences in social-cognitive determinants, intention and behavior were found for health care professionals, compared with the control group. We narrowed the intervention group and no significant differences were found in intention and behavior, except for barriers. Results showed a significant overall difference in barriers between the intervention and the control group (F1=4.128, P=.02). Conclusions: The intervention was used by less than half of the participants and did not improve health care professionals’ and patients’ cardiovascular risk-reduction behavior. The website was not used intensively because of time and organizational constraints. Professionals in the intervention group experienced higher levels of barriers to encouraging patients, than professionals in the control group. No improvements were detected in the processes of shared decision making and patient self-management. Although participant education level was relatively high and the intervention was pre-tested, it is possible that the way the information was presented could be the reason for low participation and high dropout. Further research embedded in professionals’ regular consultations with patients is required with specific emphasis on the processes of dissemination and implementation of innovations in patient-centered care. Trial Registration: Netherlands Trial Register Number (NTR): NTR2584; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2584 (Archived by WebCite at http://www.webcitation.org/6STirC66r). %M 25337988 %R 10.2196/jmir.3170 %U http://www.jmir.org/2014/10/e211/ %U https://doi.org/10.2196/jmir.3170 %U http://www.ncbi.nlm.nih.gov/pubmed/25337988 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 10 %P e232 %T Posttreatment Attrition and Its Predictors, Attrition Bias, and Treatment Efficacy of the Anxiety Online Programs %A AL-Asadi,Ali M %A Klein,Britt %A Meyer,Denny %+ Department of Arts and Education, Grande Prairie Regional College, 10726 - 106 Ave, Grande Prairie, AB, T8V 4C4, Canada, 1 780 539 2061, aalasadi@gprc.ab.ca %K posttreatment attrition %K posttreatment predictors %K treatment efficacy %K online therapy %K e-mental health %K cognitive behavioral therapy %K Internet interventions %K fully automated %K self-help %K Web treatment %K generalized anxiety disorder %K obsessive compulsive disorder %D 2014 %7 14.10.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Although relatively new, the field of e-mental health is becoming more popular with more attention given to researching its various aspects. However, there are many areas that still need further research, especially identifying attrition predictors at various phases of assessment and treatment delivery. Objective: The present study identified the predictors of posttreatment assessment completers based on 24 pre- and posttreatment demographic and personal variables and 1 treatment variable, their impact on attrition bias, and the efficacy of the 5 fully automated self-help anxiety treatment programs for generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder with or without agoraphobia (PD/A), obsessive-compulsive disorder (OCD), and posttraumatic stress disorder (PTSD). Methods: A complex algorithm was used to diagnose participants’ mental disorders based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition, Text Revision; DSM-IV-TR). Those who received a primary or secondary diagnosis of 1 of 5 anxiety disorders were offered an online 12-week disorder-specific treatment program. A total of 3199 individuals did not formally drop out of the 12-week treatment cycle, whereas 142 individuals formally dropped out. However, only 347 participants who completed their treatment cycle also completed the posttreatment assessment measures. Based on these measures, predictors of attrition were identified and attrition bias was examined. The efficacy of the 5 treatment programs was assessed based on anxiety-specific severity scores and 5 additional treatment outcome measures. Results: On average, completers of posttreatment assessment measures were more likely to be seeking self-help online programs; have heard about the program from traditional media or from family and friends; were receiving mental health assistance; were more likely to learn best by reading, hearing and doing; had a lower pretreatment Kessler-6 total score; and were older in age. Predicted probabilities resulting from these attrition variables displayed no significant attrition bias using Heckman’s method and thus allowing for the use of completer analysis. Six treatment outcome measures (Kessler-6 total score, number of diagnosed disorders, self-confidence in managing mental health issues, quality of life, and the corresponding pre- and posttreatment severity for each program-specific anxiety disorder and for major depressive episode) were used to assess the efficacy of the 5 anxiety treatment programs. Repeated measures MANOVA revealed a significant multivariate time effect for all treatment outcome measures for each treatment program. Follow-up repeated measures ANOVAs revealed significant improvements on all 6 treatment outcome measures for GAD and PTSD, 5 treatment outcome measures were significant for SAD and PD/A, and 4 treatment outcome measures were significant for OCD. Conclusions: Results identified predictors of posttreatment assessment completers and provided further support for the efficacy of self-help online treatment programs for the 5 anxiety disorders. Trial Registration: Australian and New Zealand Clinical Trials Registry ACTRN121611000704998; http://www.anzctr.org.au/trial_view.aspx?ID=336143 (Archived by WebCite at http://www.webcitation.org/618r3wvOG). %M 25316533 %R 10.2196/jmir.3513 %U http://www.jmir.org/2014/10/e232/ %U https://doi.org/10.2196/jmir.3513 %U http://www.ncbi.nlm.nih.gov/pubmed/25316533 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 10 %P e231 %T Development and Preliminary Evaluation of an Internet-Based Healthy Eating Program: Randomized Controlled Trial %A Tapper,Katy %A Jiga-Boy,Gabriela %A Maio,Gregory R %A Haddock,Geoffrey %A Lewis,Michael %+ Department of Psychology, City University London, Social Sciences Building, Whiskin Street, London, EC1R 0JD, United Kingdom, 44 20 7040 8500, katy.tapper.1@city.ac.uk %K social values %K diet %K fruit %K vegetables %K saturated fat %K added sugar %K motivation %K Internet %K health promotion %K psychology %D 2014 %7 10.10.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: The HealthValues Healthy Eating Programme is a standalone Internet-based intervention that employs a novel strategy for promoting behavior change (analyzing one’s reasons for endorsing health values) alongside other psychological principles that have been shown to influence behavior. The program consists of phases targeting motivation (dietary feedback and advice, analyzing reasons for health values, thinking about health-related desires, and concerns), volition (implementation intentions with mental contrasting), and maintenance (reviewing tasks, weekly tips). Objective: The aim was to examine the effects of the program on consumption of fruit and vegetables, saturated fat, and added sugar over a 6-month period. Methods: A total of 82 females and 18 males were recruited using both online and print advertisements in the local community. They were allocated to an intervention or control group using a stratified block randomization protocol. The program was designed such that participants logged onto a website every week for 24 weeks and completed health-related measures. Those allocated to the intervention group also completed the intervention tasks at these sessions. Additionally, all participants attended laboratory sessions at baseline, 3 months, and 6 months. During these sessions, participants completed a food frequency questionnaire (FFQ, the Block Fat/Sugar/Fruit/Vegetable Screener, adapted for the UK), and researchers (blind to group allocation) measured their body mass index (BMI), waist-to-hip ratio (WHR), and heart rate variability (HRV). Results: Data were analyzed using a series of ANOVA models. Per protocol analysis (n=92) showed a significant interaction for fruit and vegetable consumption (P=.048); the intervention group increased their intake between baseline and 6 months (3.7 to 4.1 cups) relative to the control group (3.6 to 3.4 cups). Results also showed overall reductions in saturated fat intake (20.2 to 15.6 g, P<.001) and added sugar intake (44.6 to 33.9 g, P<.001) during this period, but there were no interactions with group. Similarly, there were overall reductions in BMI (27.7 to 27.3 kg/m2, P=.001) and WHR (0.82 to 0.81, P=.009), but no interactions with group. The intervention did not affect alcohol consumption, physical activity, smoking, or HRV. Data collected during the online sessions suggested that the changes in fruit and vegetable consumption were driven by the motivational and maintenance phases of the program. Conclusions: Results suggest that the program helped individuals to increase their consumption of fruit and vegetables and to sustain this over a 6-month period. The observed reduction in fat and sugar intake suggests that monitoring behaviors over time is effective, although further research is needed to confirm this conclusion. The Web-based nature of the program makes it a potentially cost-effective way of promoting healthy eating. %M 25305376 %R 10.2196/jmir.3534 %U http://www.jmir.org/2014/10/e231/ %U https://doi.org/10.2196/jmir.3534 %U http://www.ncbi.nlm.nih.gov/pubmed/25305376 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 10 %P e217 %T The Impact of an Incentive on the Use of an Online Self-Directed Wellness and Self-Management Program %A Hibbard,Judith H %A Greene,Jessica %+ University of Oregon-1209, Health Policy Research Group, 119 Hendricks Hall, Eugene, OR, 97403-1209, United States, 1 541 346 3364, jhibbard@uoregon.edu %K empowerment %K health promotion %K Internet %K incentives %K patient activation %D 2014 %7 02.10.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Those who pay for health care are increasingly looking for strategies to influence individuals to take a more active role in managing their health. Incenting health plan members and/or employees to participate in wellness programs is a widely used approach. Objective: In this study, we examine financial incentives to health plan members to participate in an online self-management/wellness program—US $20 for completing the patient activation measure (PAM) and an additional US $40 for completing 8 learning modules. We examined whether the characteristics of plan members differed by the degree to which they responded to the incentives. Further, we examined whether participation in the wellness program was associated with improvements in PAM scores and changes in health care utilization. Methods: This retrospective study compared demographic characteristics and change in PAM scores and health utilization for 144,625 health plan members in 2011. Four groups were compared: (1) those who were offered the incentives but chose not to participate (n=128,634), (2) those who received the initial incentive (PAM only) but did not complete 8 topics (n=7099), (3) those who received both incentives (completing 8 topics but no more) (n=2693), and (4) those who received both incentives and continued using the online program beyond what was required by the incentives (n=6249). Results: The vast majority of health plan members did not participate in the program (88.91%, 128,634/144,675). Of those who participated, only 7099 of 16,041 (44.25%) completed the PAM for the first incentive, 2693 (16.79%) completed 8 topics for the second incentive, and 6249 (38.96%) received both incentives and continued using the program beyond the incentive requirements. Nonparticipants were more likely to be men and to have lower health risk scores on average than the other three groups of participants (P<.001). In multivariate regression models, those who used the online program (8 topics or beyond) increased their PAM score by approximately 1 point more than those who only took the PAM and did not use the wellness program (P<.03). In addition, emergency department visits were lower for all groups who responded to any level of the incentive as compared to those who did not (P<.01). No differences were found in other types of utilization. Conclusions: The incentive was not sufficient to spark most health plan members to use the wellness program. However, the fact that many program participants went beyond the incentive in their use of the online wellness program suggests that the users of the online program found value in using it, and it was their own internal motivation that stimulated this additional use. Providing an incentive for program participation may be an effective pathway for working with less activated patients, particularly if the program is tailored to the needs of the less activated. %M 25280348 %R 10.2196/jmir.3239 %U http://www.jmir.org/2014/10/e217/ %U https://doi.org/10.2196/jmir.3239 %U http://www.ncbi.nlm.nih.gov/pubmed/25280348 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 9 %P e226 %T Short-Term Effectiveness of Web-Based Guided Self-Help for Phobic Outpatients: Randomized Controlled Trial %A Kok,Robin N %A van Straten,Annemieke %A Beekman,Aartjan T F %A Cuijpers,Pim %+ Department of Clinical Psychology and the EMGO institute for Health and Care Research, VU University Amsterdam, van der Boechorststraat 1, Amsterdam, 1081 BT, Netherlands, 31 205983833, r.n.kok@vu.nl %K phobias %K phobic disorders %K anxiety disorders %K Web-based intervention %K Internet therapy %K randomized controlled trial %K outpatients %D 2014 %7 29.09.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-based guided self-help has been successfully used in the general population, but it is unknown whether this method can be effectively used in outpatient clinics for patients waiting for face-to-face psychotherapy for phobias. Objective: The aim was to assess the clinical effectiveness of Phobias Under Control, an Internet-based intervention based on exposure therapy with weekly guidance. Methods: We conducted a randomized controlled trial, recruiting 212 outpatients scheduled to receive face-to-face psychotherapy for any type of phobia at an outpatient clinic. Participants suffering from at least 1 DSM-IV or ICD-10 classified phobia (social phobia, agoraphobia with or without panic disorder, and/or specific phobia as ascertained by a telephone interview at baseline) were randomly allocated to either a 5-week Internet-based guided self-help program based on exposure therapy with weekly student support followed by face-to-face psychotherapy (n=105) or a wait-list control group followed by face-to-face psychotherapy (n=107). Primary outcome was the Fear Questionnaire (FQ). Secondary outcomes were the Beck Anxiety Inventory (BAI) and Center of Epidemiological Studies-Depression scale (CES-D). Assessments took place by telephone at baseline (T0) and on the Internet at posttest (T1, self-assessment at 5 weeks after baseline). Missing data at T1 were imputed. Results: At posttest, analysis of covariance on the intention-to-treat sample showed significant but small effect sizes between intervention and control groups on the FQ (d=0.35, P=.02), CES-D (d=0.34, P=.03), and a nonsignificant effect size on the BAI (d=0.28. P=.05). Although initial acceptance was good, high nonresponse was observed, with 86 of 212 participants (40.5%) lost to follow-up at T1 and only 14 of 105 (13.3%) intervention participants finishing all 5 weeks. Conclusions: Phobias Under Control is modestly effective in lowering phobic and depressive symptoms in a relatively short period and may be clinically beneficial when implemented in routine outpatient practice. Trial Registration: Netherlands Trial Register NTR2233; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2233 (Archived by WebCite at http://www.webcitation.org/6O2ioOQSs). %M 25266929 %R 10.2196/jmir.3429 %U http://www.jmir.org/2014/9/e226/ %U https://doi.org/10.2196/jmir.3429 %U http://www.ncbi.nlm.nih.gov/pubmed/25266929 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 9 %P e215 %T Web-Based Self-Assessment Health Tools: Who Are the Users and What Is the Impact of Missing Input Information? %A Neufingerl,Nicole %A Cobain,Mark R %A Newson,Rachel S %+ Nutrition & Health Department, Unilever Research & Development, Olivier van Noortlaan 120, Vlaardingen, 3133 AT, Netherlands, 31 10460 ext 5155, nicole.neufingerl@unilever.com %K cardiovascular disease %K risk assessment %K Web applications %K consumer health information %K preventive health services %K cholesterol %K blood pressure %D 2014 %7 26.09.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based health applications, such as self-assessment tools, can aid in the early detection and prevention of diseases. However, there are concerns as to whether such tools actually reach users with elevated disease risk (where prevention efforts are still viable), and whether inaccurate or missing information on risk factors may lead to incorrect evaluations. Objective: This study aimed to evaluate (1) evaluate whether a Web-based cardiovascular disease (CVD) risk communication tool (Heart Age tool) was reaching users at risk of developing CVD, (2) the impact of awareness of total cholesterol (TC), HDL-cholesterol (HDL-C), and systolic blood pressure (SBP) values on the risk estimates, and (3) the key predictors of awareness and reporting of physiological risk factors. Methods: Heart Age is a tool available via a free open access website. Data from 2,744,091 first-time users aged 21-80 years with no prior heart disease were collected from 13 countries in 2009-2011. Users self-reported demographic and CVD risk factor information. Based on these data, an individual’s 10-year CVD risk was calculated according to Framingham CVD risk models and translated into a Heart Age. This is the age for which the individual’s reported CVD risk would be considered “normal”. Depending on the availability of known TC, HDL-C, and SBP values, different algorithms were applied. The impact of awareness of TC, HDL-C, and SBP values on Heart Age was determined using a subsample that had complete risk factor information. Results: Heart Age users (N=2,744,091) were mostly in their 20s (22.76%) and 40s (23.99%), female (56.03%), had multiple (mean 2.9, SD 1.4) risk factors, and a Heart Age exceeding their chronological age (mean 4.00, SD 6.43 years). The proportion of users unaware of their TC, HDL-C, or SBP values was high (77.47%, 93.03%, and 46.55% respectively). Lacking awareness of physiological risk factor values led to overestimation of Heart Age by an average 2.1-4.5 years depending on the (combination of) unknown risk factors (P<.001). Overestimation was greater in women than in men, increased with age, and decreased with increasing CVD risk. Awareness of physiological risk factor values was higher among diabetics (OR 1.47, 95% CI 1.46-1.50 and OR 1.74, 95% CI 1.71-1.77), those with family history of CVD (OR 1.22, 95% CI 1.22-1.23 and OR 1.43, 95% CI 1.42-1.44), and increased with age (OR 1.05, 95% CI 1.05-1.05 and OR 1.07, 95% CI 1.07-1.07). It was lower in smokers (OR 0.52, 95% CI 0.52-0.53 and OR 0.71, 95% CI 0.71-0.72) and decreased with increasing Heart Age (OR 0.92, 95% CI 0.92-0.92 and OR 0.97, 95% CI 0.96-0.97) (all P<.001). Conclusions: The Heart Age tool reached users with low-moderate CVD risk, but with multiple elevated CVD risk factors, and a heart age higher than their real age. This highlights that Web-based self-assessment health tools can be a useful means to interact with people who are at risk of developing disease, but where interventions are still viable. Missing information in the self-assessment health tools was shown to result in inaccurate self-health assessments. Subgroups at risk of not knowing their risk factors are identifiable and should be specifically targeted in health awareness programs. %M 25261155 %R 10.2196/jmir.3146 %U http://www.jmir.org/2014/9/e215/ %U https://doi.org/10.2196/jmir.3146 %U http://www.ncbi.nlm.nih.gov/pubmed/25261155 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 9 %P e218 %T Effects of a Guided Web-Based Smoking Cessation Program With Telephone Counseling: A Cluster Randomized Controlled Trial %A Mehring,Michael %A Haag,Max %A Linde,Klaus %A Wagenpfeil,Stefan %A Schneider,Antonius %+ Institute of General Practice, Klinikum rechts der Isar, Technische Universität München, Orleansstr. 47, Munich, 81667, Germany, 49 614658914, michael.mehring@tum.de %K smoking cessation %K Web-based %K randomized controlled trial %K primary care %D 2014 %7 24.09.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Preliminary findings suggest that Web-based interventions may be effective in achieving significant smoking cessation. To date, very few findings are available for primary care patients, and especially for the involvement of general practitioners. Objective: Our goal was to examine the short-term effectiveness of a fully automated Web-based coaching program in combination with accompanied telephone counseling in smoking cessation in a primary care setting. Methods: The study was an unblinded cluster-randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education, motivation, exercise guidance, daily short message service (SMS) reminding, weekly feedback through Internet, and active monitoring by general practitioners. All components of the program are fully automated. Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program. The main outcome was the biochemically confirmed smoking status after 12 weeks. Results: We recruited 168 participants (86 intervention group, 82 control group) into the study. For 51 participants from the intervention group and 70 participants from the control group, follow-up data were available both at baseline and 12 weeks. Very few patients (9.8%, 5/51) from the intervention group and from the control group (8.6%, 6/70) successfully managed smoking cessation (OR 0.86, 95% CI 0.25-3.0; P=.816). Similar results were found within the intent-to-treat analysis: 5.8% (5/86) of the intervention group and 7.3% (6/82) of the control group (OR 1.28, 95% CI 0.38-4.36; P=.694). The number of smoked cigarettes per day decreased on average by 9.3 in the intervention group and by 6.6 in the control group (2.7 mean difference; 95% CI -5.33 to -0.58; P=.045). After adjustment for the baseline value, age, gender, and height, this significance decreases (mean difference 2.2; 95% CI -4.7 to 0.3; P=.080). Conclusions: This trial did not show that the tested Web-based intervention was effective for achieving smoking cessation compared to usual care. The limited statistical power and the high drop-out rate may have reduced the study’s ability to detect significant differences between the groups. Further randomized controlled trials are needed in larger populations and to investigate the long-term outcome. Trial Registration: German Register for Clinical Trials, registration number DRKS00003067; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ ID=DRKS00003067 (Archived by WebCite at http://www.webcitation.org/6Sff1YZpx). %M 25253539 %R 10.2196/jmir.3536 %U http://www.jmir.org/2014/9/e218/ %U https://doi.org/10.2196/jmir.3536 %U http://www.ncbi.nlm.nih.gov/pubmed/25253539 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 9 %P e209 %T Web-Based Intervention Programs for Depression: A Scoping Review and Evaluation %A Renton,Tian %A Tang,Herman %A Ennis,Naomi %A Cusimano,Michael D %A Bhalerao,Shree %A Schweizer,Tom A %A Topolovec-Vranic,Jane %+ Trauma and Neurosurgery Program, St Michael's Hospital, Bond 3-012, 30 Bond Street, Toronto, ON, M5B 1W8, Canada, 1 416 864 6060 ext 3421, topolovec-vranicj@smh.ca %K depression %K Web-based interventions %K interactive treatment %K health care access %K mental health %K technology %D 2014 %7 23.09.2014 %9 Review %J J Med Internet Res %G English %X Background: Although depression is known to affect millions of people worldwide, individuals seeking aid from qualified health care professionals are faced with a number of barriers to treatment including a lack of treatment resources, limited number of qualified service providers, stigma associated with diagnosis and treatment, prolonged wait times, cost, and barriers to accessibility such as transportation and clinic locations. The delivery of depression interventions through the Internet may provide a practical solution to addressing some of these barriers. Objective: The purpose of this scoping review was to answer the following questions: (1) What Web-delivered programs are currently available that offer an interactive treatment component for depression?, (2) What are the contents, accessibility, and usability of each identified program?, and (3) What tools, supports, and research evidence are available for each identified program? Methods: Using the popular search engines Google, Yahoo, and Bing (Canadian platforms), two reviewers independently searched for interactive Web-based interventions targeting the treatment of depression. The Beacon website, an information portal for online health applications, was also consulted. For each identified program, accessibility, usability, tools, support, and research evidence were evaluated and programs were categorized as evidence-based versus non-evidence-based if they had been the subject of at least one randomized controlled trial. Programs were scored using a 28-point rating system, and evidence- versus non-evidence-based programs were compared and contrasted. Although this review included all programs meeting exclusion and inclusion criteria found using the described search method, only English language Web-delivered depression programs were awarded an evaluation score. Results: The review identified 32 programs meeting inclusion criteria. There was a great deal of variability among the programs captured in this evaluation. Many of the programs were developed for general adolescent or adult audiences, with few (n=2) focusing on special populations (eg, military personnel, older adults). Cognitive behavioral therapy was the most common therapeutic approach used in the programs described. Program interactive components included mood assessments and supplementary homework sheets such as activity planning and goal setting. Only 12 of the programs had published evidence in support of their efficacy and treatment of depressive symptoms. Conclusions: There are a number of interactive depression interventions available through the Internet. Recommendations for future programs, or the adaptation of existing programs include offering a greater selection of alternative languages, removing registration restrictions, free trial periods for programs requiring user fees, and amending programs to meet the needs of special populations (eg, those with cognitive and/or visual impairments). Furthermore, discussion of specific and relevant topics to the target audience while also enhancing overall user control would contribute to a more accessible intervention tool. %M 25249003 %R 10.2196/jmir.3147 %U http://www.jmir.org/2014/9/e209/ %U https://doi.org/10.2196/jmir.3147 %U http://www.ncbi.nlm.nih.gov/pubmed/25249003 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 9 %P e186 %T A Web-Based Program Improves Physical Activity Outcomes in a Primary Care Angina Population: Randomized Controlled Trial %A Devi,Reena %A Powell,John %A Singh,Sally %+ Coventry University, Applied Research Centre in Health and Lifestyle Interventions, Priory Street, Coventry, CV1 5FB, United Kingdom, 44 24 7688 7688, reena.devi@coventry.ac.uk %K stable angina %K cardiac rehabilitation %K Web-based interventions %K secondary prevention %K primary health care %K physical activity %D 2014 %7 12.09.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Angina affects more than 50 million people worldwide. Secondary prevention interventions such as cardiac rehabilitation are not widely available for this population. An Internet-based version could offer a feasible alternative. Objective: Our aim was to examine the effectiveness of a Web-based cardiac rehabilitation program for those with angina. Methods: We conducted a randomized controlled trial, recruiting those diagnosed with angina from general practitioners (GPs) in primary care to an intervention or control group. Intervention group participants were offered a 6-week Web-based rehabilitation program (“ActivateYourHeart”). The program was introduced during a face-to-face appointment and then delivered via the Internet (no further face-to-face contact). The program contained information about the secondary prevention of coronary heart disease (CHD) and set each user goals around physical activity, diet, managing emotions, and smoking. Performance against goals was reviewed throughout the program and goals were then reset/modified. Participants completed an online exercise diary and communicated with rehabilitation specialists through an email link/synchronized chat room. Participants in the control group continued with GP treatment as usual, which consisted of being placed on a CHD register and attending an annual review. Outcomes were measured at 6-week and 6-month follow-ups during face-to-face assessments. The primary outcome measure was change in daily steps at 6 weeks, measured using an accelerometer. Secondary outcome measures were energy expenditure (EE), duration of sedentary activity (DSA), duration of moderate activity (DMA), weight, diastolic/systolic blood pressure, and body fat percentage. Self-assessed questionnaire outcomes included fat/fiber intake, anxiety/depression, self-efficacy, and quality of life (QOL). Results: A total of 94 participants were recruited and randomized to the intervention (n=48) or the usual care (n=46) group; 84 and 73 participants completed the 6-week and 6-month follow-ups, respectively. The mean number of log-ins to the program was 18.68 (SD 13.13, range 1-51), an average of 3 log-ins per week per participant. Change in daily steps walked at the 6-week follow-up was +497 (SD 2171) in the intervention group and –861 (SD 2534) in the control group (95% CI 263-2451, P=.02). Significant intervention effects were observed at the 6-week follow-up in EE (+43.94 kcal, 95% CI 43.93-309.98, P=.01), DSA (–7.79 minutes, 95% CI –55.01 to –7.01, P=.01), DMA (+6.31 minutes, 95% CI 6.01-51.20, P=.01), weight (–0.56 kg, 95% CI –1.78 to –0.15, P=.02), self-efficacy (95% CI 0.30-4.79, P=.03), emotional QOL score (95% CI 0.01-0.54, P=.04), and angina frequency (95% CI 8.57-35.05, P=.002). Significant benefits in angina frequency (95% CI 1.89-29.41, P=.02) and social QOL score (95% CI 0.05-0.54, P=.02) were also observed at the 6-month follow-up. Conclusions: An Internet-based secondary prevention intervention could be offered to those with angina. A larger pragmatic trial is required to provide definitive evidence of effectiveness and cost-effectiveness. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 90110503; http://www.controlled-trials.com/ISRCTN90110503/ISRCTN90110503 (Archived by WebCite at http://www.webcitation.org/6RYVOQFKM). %M 25217464 %R 10.2196/jmir.3340 %U http://www.jmir.org/2014/9/e186/ %U https://doi.org/10.2196/jmir.3340 %U http://www.ncbi.nlm.nih.gov/pubmed/25217464 %0 Journal Article %@ 2368-7959 %I JMIR Publications Inc. %V 1 %N 1 %P e1 %T A Web-Based Intervention for Users of Amphetamine-Type Stimulants: 3-Month Outcomes of a Randomized Controlled Trial %A Tait,Robert J %A McKetin,Rebecca %A Kay-Lambkin,Frances %A Carron-Arthur,Bradley %A Bennett,Anthony %A Bennett,Kylie %A Christensen,Helen %A Griffiths,Kathleen M %+ National Drug Research Institute, Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, 6845, Australia, 61 8 92661610, robert.tait@curtin.edu.au %K amphetamine related disorders %K Internet %K World Wide Web %K randomized control trial %K cognitive therapy %K online %K Web-based %K motivational enhancement %K intervention %D 2014 %7 11.09.2014 %9 Original Paper %J JMIR Mental Health %G English %X Background: Among illicit drugs, the prevalence of amphetamine-type stimulant (ATS) use is second only to cannabis. Currently, there are no approved pharmacotherapies for ATS problems, but some face-to-face psychotherapies are effective. Web-based interventions have proven to be effective for some substance use problems, but none has specifically targeted ATS users. Objective: The objective of the study was to evaluate the effectiveness of a Web-based intervention for ATS problems on a free-to-access site compared with a waitlist control group. Methods: We used a randomized controlled trial design. The primary outcome measure was self-reported ATS use in the past three months assessed using the Alcohol, Smoking, Substance Involvement Screening Test (ASSIST). Other measures included quality of life (EUROHIS score), psychological distress (K-10 score), days out of role, poly-drug use, general help-seeking intentions, actual help-seeking, and “readiness to change”. The intervention consisted of three fully automated, self-guided modules based on cognitive behavioral therapy and motivation enhancement. The analysis was an intention-to-treat analysis using generalized estimating equation models, with a group by time interaction as the critical assessment. Results: We randomized 160 people (intervention n=81, control n=79). At three months, 35/81 (43%) intervention and 45/79 (57%) control participants provided follow-up data. In the intervention group, 51/81 (63%) completed at least one module. The only significant group by time interaction was for days out of role. The pre/post change effect sizes showed small changes (range d=0.14 to 0.40) favoring the intervention group for poly-drug use, distress, actual help-seeking, and days out of role. In contrast, the control group was favored by reductions in ATS use, improvements in quality of life, and increases in help-seeking intentions (range d=0.09 to 0.16). Conclusions: This Web-based intervention for ATS use produced few significant changes in outcome measures. There were moderate, but nonsignificant reductions in poly-drug use, distress, days partially out of role, and increases in help-seeking. However, high levels of participant attrition, plus low levels of engagement with the modules, preclude firm conclusions being drawn on the efficacy of the intervention and emphasize the problems of engaging this group of clients in a fully automated program. Trial Registration: Australian and New Zealand Clinical Trials Registry: ACTRN 12611000947909; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000947909 (Archived by WebCite at http://www.webcitation.org/6SHTxEnzP). %M 26543901 %R 10.2196/mental.3278 %U https://mental.jmir.org/2014/1/e1/ %U https://doi.org/10.2196/mental.3278 %U http://www.ncbi.nlm.nih.gov/pubmed/26543901 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 9 %P e208 %T Norwegian General Practitioners’ Perspectives on Implementation of a Guided Web-Based Cognitive Behavioral Therapy for Depression: A Qualitative Study %A Wilhelmsen,Maja %A Høifødt,Ragnhild Sørensen %A Kolstrup,Nils %A Waterloo,Knut %A Eisemann,Martin %A Chenhall,Richard %A Risør,Mette Bech %+ Department of Community Medicine, Faculty of Health Sciences, UiT The Arctic University of Norway, Breivika, Tromsø, 9037, Norway, 47 99001559, maja.wilhelmsen@uit.no %K mental health %K Internet %K telemedicine %K qualitative research %K primary health care %K cognitive therapy %K depression %D 2014 %7 10.09.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Previous research suggests that Internet-based cognitive behavioral therapy (ICBT) has a positive effect on symptoms of depression. ICBT appears to be more effective with therapist support, but it is unclear what this support should comprise. General practitioners (GPs) have positive attitudes toward ICBT. However, ICBT is rarely used in regular care in general practice. More research is warranted to integrate the potential of ICBT as part of regular care. Objective: The aim of this study was to explore aspects perceived by GPs to affect the implementation of guided ICBT in daily practice. Understanding their perspectives may contribute to improving the treatment of depression in the context of general practice. Methods: A training package (3-day course) introducing a Norwegian translation of the ICBT program MoodGYM was developed and presented to GPs in Norway. Following training, GPs were asked to include guided ICBT in their regular care of patients with symptoms of depression by providing brief, face-to-face follow-up consultations between modules. We interviewed 11 GPs who had taken the course. Our interview guide comprised open questions that encouraged GPs to frame their responses using examples from their experiences when implementing ICBT. Thematic analysis was chosen to explore patterns across the data. Results: An overall belief that ICBT would benefit both the patients’ health and the GPs’ own work satisfaction prompted the GPs to take the ICBT course. ICBT motivated them to invest time and effort in improving treatment. The most important motivating aspects in MoodGYM were that a program based on cognitive behavioral therapy could add a structured agenda to their consultations and empower depressed patients. Organizational aspects, such as a lack of time and varied practice, inhibited the use of ICBT. Inadequate knowledge, recalling the program, and changing own habits were also challenging. The GPs were ambivalent about whether ICBT had a negative impact on the doctor–patient interaction in the module follow-ups. Generally, GPs made an effort to recommend MoodGYM, but the expected module follow-ups were often not provided to patients and instead the GPs returned to standard treatment. Conclusions: GPs’ feedback in the present study contribute to our understanding of the challenges of changing treatment for depression. Our findings indicated that recommending ICBT could add to the GP’s toolkit. Offering training and highlighting the following aspects may increase recommendation of ICBT by GPs: (1) ICBT is theory-based and credible, (2) ICBT increases the GPs’ work satisfaction by having a tool to offer, and (3) ICBT facilitates empowerment of patients in their own health. In addition, the present study also indicated that complex aspects must be accommodated before module follow-ups can be incorporated into GPs’ treatment of depression. %M 25208886 %R 10.2196/jmir.3556 %U http://www.jmir.org/2014/9/e208/ %U https://doi.org/10.2196/jmir.3556 %U http://www.ncbi.nlm.nih.gov/pubmed/25208886 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 9 %P e205 %T Facebook Apps for Smoking Cessation: A Review of Content and Adherence to Evidence-Based Guidelines %A Jacobs,Megan A %A Cobb,Caroline O %A Abroms,Lorien %A Graham,Amanda L %+ Schroeder Institute for Tobacco Research and Policy Studies, Legacy, 1724 Massachusetts Avenue, NW, Washington, DC, 20036, United States, 1 202 454 5753, mjacobs@legacyforhealth.org %K Facebook %K smoking cessation/methods %K social media %K apps %D 2014 %7 09.09.2014 %9 Short Paper %J J Med Internet Res %G English %X Background: Facebook is the most popular social network site, with over 1 billion users globally. There are millions of apps available within Facebook, many of which address health and health behavior change. Facebook may represent a promising channel to reach smokers with cessation interventions via apps. To date, there have been no published reports about Facebook apps for smoking cessation. Objective: The purpose of this study was to review the features and functionality of Facebook apps for smoking cessation and to determine the extent to which they adhere to evidence-based guidelines for tobacco dependence treatment. Methods: In August 2013, we searched Facebook and three top Internet search engines using smoking cessation keywords to identify relevant Facebook apps. Resultant apps were screened for eligibility (smoking cessation-related, English language, and functioning). Eligible apps were reviewed by 2 independent coders using a standardized coding scheme. Coding included content features (interactive, informational, and social) and adherence to an established 20-item index (possible score 0-40) derived from the US Public Health Service’s Clinical Practice Guidelines for Treating Tobacco Use and Dependence. Results: We screened 22 apps for eligibility; of these, 12 underwent full coding. Only 9 apps were available on Facebook. Facebook apps fell into three broad categories: public pledge to quit (n=3), quit-date–based calculator/tracker (n=4), or a multicomponent quit smoking program (n=2). All apps incorporated interactive, informational, and social features except for two quit-date–based calculator/trackers apps (lacked informational component). All apps allowed app-related posting within Facebook (ie, on self/other Facebook profile), and four had a within-app “community” feature to enable app users to communicate with each other. Adherence index summary scores among Facebook apps were low overall (mean 15.1, SD 7.8, range 7-30), with multicomponent apps scoring the highest. Conclusions: There are few smoking cessation apps available within Facebook. Among those available, adherence to cessation treatment guidelines was low. Smoking cessation interventions provided via the Facebook platform are a unique and as yet untapped treatment strategy that can harness existing social support and social networks for quitting. Research is needed to examine whether apps that adhere to clinical practice guidelines for tobacco dependence treatment are more effective in promoting cessation than those that do not. %M 25205129 %R 10.2196/jmir.3491 %U http://www.jmir.org/2014/9/e205/ %U https://doi.org/10.2196/jmir.3491 %U http://www.ncbi.nlm.nih.gov/pubmed/25205129 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 9 %P e203 %T A Web-Based Sexual Violence Bystander Intervention for Male College Students: Randomized Controlled Trial %A Salazar,Laura F %A Vivolo-Kantor,Alana %A Hardin,James %A Berkowitz,Alan %+ Georgia State University, School of Public Health, PO Box 3984, Atlanta, GA, 30302-3984, United States, 1 404 413 1396, lsalazar1@gsu.edu %K Internet %K sex offenses %K rape %K universities %K students %K public health %D 2014 %7 05.09.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Bystander intervention approaches offer promise for reducing rates of sexual violence on college campuses. Most interventions are in-person small-group formats, which limit their reach and reduce their overall public health impact. Objective: This study evaluated the efficacy of RealConsent, a Web-based bystander approach to sexual violence prevention, in enhancing prosocial intervening behaviors and preventing sexual violence perpetration. Methods: A random probability sample of 743 male undergraduate students (aged 18 to 24 years) attending a large, urban university located in the southeastern United States was recruited online and randomized to either RealConsent (n=376) or a Web-based general health promotion program (n=367). Participants were surveyed online at baseline, postintervention, and 6-months postintervention. RealConsent was delivered via a password-protected Web portal that contained six 30-minute media-based and interactive modules covering knowledge of informed consent, communication skills regarding sex, the role of alcohol and male socialization in sexual violence, empathy for rape victims, and bystander education. Primary outcomes were self-reported prosocial intervening behaviors and sexual violence perpetration. Secondary outcomes were theoretical mediators (eg, knowledge, attitudes). Results: At 6-month follow-up RealConsent participants intervened more often (P=.04) and engaged in less sexual violence perpetration (P=.04) compared to controls. In addition, RealConsent participants reported greater legal knowledge of sexual assault (P<.001), greater knowledge of effective consent (P<.001), less rape myths (P<.001), greater empathy for rape victims (P<.001), less negative date rape attitudes (P<.001), less hostility toward women (P=.01), greater intentions to intervene (P=.04), less hyper-gender ideology (P<.001), less positive outcome expectancies for nonconsensual sex (P=.03), more positive outcome expectancies for intervening (P<.001), and less comfort with other men’s inappropriate behaviors (P<.001). Conclusions: Our results support the efficacy of RealConsent. Due to its Web-based format, RealConsent has potential for broad-based dissemination thereby increasing its overall public health impact on sexual violence. Trial Registration: Clinicaltrials.gov: NCT01903876; http://clinicaltrials.gov/show/NCT01903876 (Archived by WebCite at http://www.webcitation.org/6S1PXxWKt). %M 25198417 %R 10.2196/jmir.3426 %U http://www.jmir.org/2014/9/e203/ %U https://doi.org/10.2196/jmir.3426 %U http://www.ncbi.nlm.nih.gov/pubmed/25198417 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 9 %P e199 %T Prevention of Generalized Anxiety Disorder Using a Web Intervention, iChill: Randomized Controlled Trial %A Christensen,Helen %A Batterham,Philip %A Mackinnon,Andrew %A Griffiths,Kathleen M %A Kalia Hehir,Kanupriya %A Kenardy,Justin %A Gosling,John %A Bennett,Kylie %+ Black Dog Institute, University of New South Wales, Hospital Road, Prince of Wales Hospital, Randwick, Sydney, 2031, Australia, 61 293829288, h.christensen@blackdog.org.au %K anxiety disorders %K prevention %K early intervention %K Internet %K online systems %K cognitive behavioral therapy %D 2014 %7 02.09.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Generalized Anxiety Disorder (GAD) is a high prevalence, chronic disorder. Web-based interventions are acceptable, engaging, and can be delivered at scale. Few randomized controlled trials evaluate the effectiveness of prevention programs for anxiety, or the factors that improve effectiveness and engagement. Objective: The intent of the study was to evaluate the effectiveness of a Web-based program in preventing GAD symptoms in young adults, and to determine the role of telephone and email reminders. Methods: A 5-arm randomized controlled trial with 558 Internet users in the community, recruited via the Australian Electoral Roll, was conducted with 6- and 12-month follow-up. Five interventions were offered over a 10-week period. Group 1 (Active website) received a combined intervention of psycho-education, Internet-delivered Cognitive Behavioral Therapy (ICBT) for anxiety, physical activity promotion, and relaxation. Group 2 (Active website with telephone) received the identical Web program plus weekly telephone reminder calls. Group 3 (Active website with email) received the identical Web program plus weekly email reminders. Group 4 (Control) received a placebo website. Group 5 (Control with telephone) received the placebo website plus telephone calls. Main outcome measures were severity of anxiety symptoms as measured by the GAD 7-item scale (GAD-7) (at post-test, 6, and 12 months). Secondary measures were GAD caseness, measured by the Mini International Neuropsychiatric Interview (MINI) at 6 months, Centre for Epidemiologic Studies-Depression scale (CES-D), Anxiety Sensitivity Index (ASI), Penn State Worry Questionnaire (PSWQ), and Days out of Role. Results: GAD-7 symptoms reduced over post-test, 6-month, and 12-month follow-up. There were no significant differences between Group 4 (Control) and Groups 1 (Active website), 2 (Active website with telephone), 3 (Active website with email), or 5 (Control with telephone) at any follow-up. A total of 16 cases of GAD were identified at 6 months, comprising 6.7% (11/165) from the Active groups (1, 2, 3) and 4.5% (5/110) from the Control groups (4, 5), a difference that was not significant. CES-D, ASI, and PSWQ scores were significantly lower for the active website with email reminders at post-test, relative to the control website condition. Conclusions: Indicated prevention of GAD was not effective in reducing anxiety levels, measured by GAD-7. There were significant secondary effects for anxiety sensitivity, worry, and depression. Challenges for indicated prevention trials are discussed. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 76298775; http://www.controlled-trials.com/ISRCTN76298775 (Archived by WebCite at http://www.webcitation.org/6S9aB5MAq). %M 25270886 %R 10.2196/jmir.3507 %U http://www.jmir.org/2014/9/e199/ %U https://doi.org/10.2196/jmir.3507 %U http://www.ncbi.nlm.nih.gov/pubmed/25270886 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 2 %N 3 %P e37 %T FoodSwitch: A Mobile Phone App to Enable Consumers to Make Healthier Food Choices and Crowdsourcing of National Food Composition Data %A Dunford,Elizabeth %A Trevena,Helen %A Goodsell,Chester %A Ng,Ka Hung %A Webster,Jacqui %A Millis,Audra %A Goldstein,Stan %A Hugueniot,Orla %A Neal,Bruce %+ The George Institute for Global Health, Food Policy Division, PO Box M201 Missenden Rd, Camperdown, 2050, Australia, 61 285072529, edunford@georgeinstitute.org.au %K smartphone technology %K traffic light labeling %K food choices %K public health nutrition %K processed food %D 2014 %7 21.08.2014 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: Front-of-pack nutrition labeling (FoPL) schemes can help consumers understand the nutritional content of foods and may aid healthier food choices. However, most packaged foods in Australia carry no easily interpretable FoPL, and no standard FoPL system has yet been mandated. About two thirds of Australians now own a smartphone. Objective: We sought to develop a mobile phone app that would provide consumers with easy-to-understand nutrition information and support the selection of healthier choices when shopping for food. Methods: An existing branded food database including 17,000 Australian packaged foods underpinned the project. An iterative process of development, review, and testing was undertaken to define a user interface that could deliver nutritional information. A parallel process identified the best approach to rank foods based on nutritional content, so that healthier alternative products could be recommended. Results: Barcode scanning technology was identified as the optimal mechanism for interaction of the mobile phone with the food database. Traffic light labels were chosen as the preferred format for presenting nutritional information, and the Food Standards Australia New Zealand nutrient profiling method as the best strategy for identifying healthier products. The resulting FoodSwitch mobile phone app was launched in Australia in January 2012 and was downloaded by about 400,000 users in the first 18 months. FoodSwitch has maintained a 4-plus star rating, and more than 2000 users have provided feedback about the functionality. Nutritional information for more than 30,000 additional products has been obtained from users through a crowdsourcing function integrated within the app. Conclusions: FoodSwitch has empowered Australian consumers seeking to make better food choices. In parallel, the huge volume of crowdsourced data has provided a novel means for low-cost, real-time tracking of the nutritional composition of Australian foods. There appears to be significant opportunity for this approach in many other countries. %M 25147135 %R 10.2196/mhealth.3230 %U http://mhealth.jmir.org/2014/3/e37/ %U https://doi.org/10.2196/mhealth.3230 %U http://www.ncbi.nlm.nih.gov/pubmed/25147135 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 8 %P e194 %T How an Online Intervention to Prevent Excessive Gestational Weight Gain Is Used and by Whom: A Randomized Controlled Process Evaluation %A Demment,Margaret Mochon %A Graham,Meredith Leigh %A Olson,Christine Marie %+ Community Nutrition, Division of Nutritional Sciences, Cornell University, 370 MVR Hall, Ithaca, NY, 14853, United States, 1 607 255 2634, mmd238@cornell.edu %K online intervention %K obesity prevention %K latent class analysis %K socioeconomic differences %K demographic subgroups %K online engagement %K process evaluation %D 2014 %7 20.08.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Online interventions have emerged as a popular strategy to promote healthy behaviors. Currently, there is little agreement about how to capture online intervention engagement. It is also uncertain who engages with weight-related online interventions and how engagement differs by demographic and weight characteristics. Objective: The objectives of this study were to (1) characterize how pregnant women engaged with features of an online intervention to prevent excessive gestational weight gain, (2) identify demographic and weight status subgroups of women within the sample, and (3) examine differences in use of intervention features across the demographic and weight status subgroups. Methods: A sample of racially and socioeconomically diverse pregnant women from a northeastern US city was assigned to the intervention group in a randomized controlled trial to prevent excessive gestational weight gain (n=1014). The intervention website included these features: weight-gain tracker, health-related articles, blogs, physical activity and diet goal-setting tools, and local resources. Engagement variables were created to capture the amount, consistency, and patterns of feature use across pregnancy using latent class analysis. Demographic/weight status subgroups were also created using latent class analysis. Differences in engagement across the demographic/weight status subgroups were examined using chi-square analysis. Results: Six engagement patterns emerged: “super-users” (13.02%, 132/1014), “medium-users” (14.00%, 142/1014), “consistent weight-tracker users” (14.99%, 152/1014); “almost consistent weight-tracker users” (21.99%, 223/1014), “inconsistent weight-tracker users” (15.98%, 162/1014), and “non-users” (20.02%, 203/1014). Four demographic/weight status subgroups emerged: three minority and one white. There were different engagement patterns by demographic/weight status subgroups. Super-users were more likely to be in the white subgroup, while non-users were more likely to be in the minority subgroups. However, around a third of women in minority subgroups were consistently or almost consistently engaging with the weight-tracker (black, young women, 32.2%, 67/208; black, heavier women, 37.9%, 50/132; Hispanic women, 27.4%, 32/117). Conclusions: While white and higher income women had higher engagement in general, depending on the measure, there was still considerable engagement by the minority and low-income women. Trial Registration: Clinicaltrials.gov: NCT01331564; http://clinicaltrials.gov/ct2/show/NCT01331564 (Archived by WebCite at http://www.webcitation.org/6Rw4yKxI5). %M 25143156 %R 10.2196/jmir.3483 %U http://www.jmir.org/2014/8/e194/ %U https://doi.org/10.2196/jmir.3483 %U http://www.ncbi.nlm.nih.gov/pubmed/25143156 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 8 %P e192 %T Behavior Change Techniques Implemented in Electronic Lifestyle Activity Monitors: A Systematic Content Analysis %A Lyons,Elizabeth J %A Lewis,Zakkoyya H %A Mayrsohn,Brian G %A Rowland,Jennifer L %+ The University of Texas Medical Branch, Institute for Translational Sciences, 301 University Blvd, Galveston, TX, 77555-0342, United States, 1 409 772 1917, ellyons@utmb.edu %K electronic activity monitor %K mobile %K mhealth %K physical activity %K behavior change technique %D 2014 %7 15.08.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Electronic activity monitors (such as those manufactured by Fitbit, Jawbone, and Nike) improve on standard pedometers by providing automated feedback and interactive behavior change tools via mobile device or personal computer. These monitors are commercially popular and show promise for use in public health interventions. However, little is known about the content of their feedback applications and how individual monitors may differ from one another. Objective: The purpose of this study was to describe the behavior change techniques implemented in commercially available electronic activity monitors. Methods: Electronic activity monitors (N=13) were systematically identified and tested by 3 trained coders for at least 1 week each. All monitors measured lifestyle physical activity and provided feedback via an app (computer or mobile). Coding was based on a hierarchical list of 93 behavior change techniques. Further coding of potentially effective techniques and adherence to theory-based recommendations were based on findings from meta-analyses and meta-regressions in the research literature. Results: All monitors provided tools for self-monitoring, feedback, and environmental change by definition. The next most prevalent techniques (13 out of 13 monitors) were goal-setting and emphasizing discrepancy between current and goal behavior. Review of behavioral goals, social support, social comparison, prompts/cues, rewards, and a focus on past success were found in more than half of the systems. The monitors included a range of 5-10 of 14 total techniques identified from the research literature as potentially effective. Most of the monitors included goal-setting, self-monitoring, and feedback content that closely matched recommendations from social cognitive theory. Conclusions: Electronic activity monitors contain a wide range of behavior change techniques typically used in clinical behavioral interventions. Thus, the monitors may represent a medium by which these interventions could be translated for widespread use. This technology has broad applications for use in clinical, public health, and rehabilitation settings. %M 25131661 %R 10.2196/jmir.3469 %U http://www.jmir.org/2014/8/e192/ %U https://doi.org/10.2196/jmir.3469 %U http://www.ncbi.nlm.nih.gov/pubmed/25131661 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 8 %P e180 %T Interactive Sections of an Internet-Based Intervention Increase Empowerment of Chronic Back Pain Patients: Randomized Controlled Trial %A Riva,Silvia %A Camerini,Anne-Linda %A Allam,Ahmed %A Schulz,Peter J %+ Institute of Communication and Health, Università della Svizzera italiana, Via Buffi 6, Lugano, 6900, Switzerland, 41 58 666 44 88, silvia.riva@usi.ch %K Internet-based intervention %K interactivity %K patient empowerment %K chronic back pain %K health outcomes %K decision %K health %K physical activity %K pain burden %K medication misuse %K gamification %D 2014 %7 13.08.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic back pain (CBP) represents a significant public health problem. As one of the most common causes of disability and sick leave, there is a need to develop cost-effective ways, such as Internet-based interventions, to help empower patients to manage their disease. Research has provided evidence for the effectiveness of Internet-based interventions in many fields, but it has paid little attention to the reasons why they are effective. Objective: This study aims to assess the impact of interactive sections of an Internet-based self-management intervention on patient empowerment, their management of the disease, and, ultimately, health outcomes. Methods: A total of 51 patients were recruited through their health care providers and randomly assigned to either an experimental group with full access to the Internet-based intervention or a control group that was denied access to the interactive sections and knew nothing thereof. The intervention took 8 weeks. A baseline, a mid-term after 4 weeks, and a final assessment after 8 weeks measured patient empowerment, physical exercise, medication misuse, and pain burden. Results: All patients completed the study. Overall, the intervention had a moderate effect (F1.52=2.83, P=.03, η2=0.30, d=0.55). Compared to the control group, the availability of interactive sections significantly increased patient empowerment (midterm assessment: mean difference=+1.2, P=.03, d=0.63; final assessment: mean difference=+0.8, P=.09, d=0.44) and reduced medication misuse (midterm assessment: mean difference=−1.5, P=.04, d=0.28; final assessment: mean difference=−1.6, P=.03, d=−0.55) in the intervention group. Both the frequency of physical exercise and pain burden decreased, but to equal measures in both groups. Conclusions: Results suggest that interactive sections as part of Internet-based interventions can positively alter patients’ feelings of empowerment and help prevent medication misuse. Detrimental effects were not observed. Trial Registration: ClinicalTrials.gov: NCT02114788; http://www.clinicaltrials.gov/ct2/show/NCT02114788 (Archived by WebCite at http://www.webcitation.org/6ROXYVoPR). %M 25119374 %R 10.2196/jmir.3474 %U http://www.jmir.org/2014/8/e180/ %U https://doi.org/10.2196/jmir.3474 %U http://www.ncbi.nlm.nih.gov/pubmed/25119374 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 7 %P e181 %T Purple: A Modular System for Developing and Deploying Behavioral Intervention Technologies %A Schueller,Stephen M %A Begale,Mark %A Penedo,Frank J %A Mohr,David C %+ Center for Behavioral Intervention Technologies, Department of Preventive Medicine, Northwestern University, 680 N Lake Shore Drive, Suite 1400, Chicago, IL, 60611, United States, 1 312 503 1403, d-mohr@northwestern.edu %K software tools %K software engineering %K open source %K evaluation methodology %K Internet intervention %K mobile intervention %K mobile health %D 2014 %7 30.07.2014 %9 Viewpoint %J J Med Internet Res %G English %X The creation, deployment, and evaluation of Web-based and mobile-based applications for health, mental health, and wellness within research settings has tended to be siloed, with each research group developing their own systems and features. This has led to technological features and products that are not sharable across research teams, thereby limiting collaboration, reducing the speed of dissemination, and raising the bar for entry into this area of research. This paper provides an overview of Purple, an extensible, modular, and repurposable system created for the development of Web-based and mobile-based applications for health behavior change. Purple contains features required to construct applications and to manage and evaluate research trials using these applications. Core functionality of Purple includes elements that support user management, content authorship, content delivery, and data management. We discuss the history and development of the Purple system guided by the rationale of producing a system that allows greater collaboration and understanding across research teams interested in investigating similar questions and using similar methods. Purple provides a useful tool to meet the needs of stakeholders involved in the creation, provision, and usage of eHealth and mHealth applications. Housed in a non-profit, academic institution, Purple also offers the potential to facilitate the diffusion of knowledge across the research community and improve our capacity to deliver useful and usable applications that support the behavior change of end users. %M 25079298 %R 10.2196/jmir.3376 %U http://www.jmir.org/2014/7/e181/ %U https://doi.org/10.2196/jmir.3376 %U http://www.ncbi.nlm.nih.gov/pubmed/25079298 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 7 %P e179 %T On Supplementing “Foot in the Door” Incentives for eHealth Program Engagement %A Mitchell,Marc Steven %A Faulkner,Guy E %+ Faculty of Kinesiology and Physical Education, Graduate Department of Exercise Sciences, University of Toronto, Athletic Center, 55 Harbord St, Toronto, ON, M5S 2W6, Canada, 1 416 660 7881, marc.mitchell@uhn.ca %K cardiovascular risk %K prevention %K rewards %D 2014 %7 25.07.2014 %9 Editorial %J J Med Internet Res %G English %X Financial health incentives, such as paying people to lose weight, are being widely implemented by Western nations and large corporations. A growing number of studies have tested the impact of incentives on health behaviors, though few have evaluated the approach on a population-scale. In this issue of the Journal of Medical Internet Research, Liu et al add to the evidence-base by examining whether a single incentive can motivate enrollment and engagement in a preventive eHealth program in a sample of 142,726 Canadian adults. While the incentives increased enrollment significantly (by a factor of about 28), a very high level of program attrition was noted (90%). The “foot in the door” incentive technique employed was insufficient; enrollees received incentives for signing-up for, but not for engaging with, the eHealth program. To supplement this technique and drive sustained behavior change, several theoretically- and empirically-based strategies are proposed. Specifically, incentives indexed to behavioral achievements over time are highlighted as one approach to boost engagement in this population in the future. %M 25092221 %R 10.2196/jmir.3701 %U http://www.jmir.org/2014/7/e179/ %U https://doi.org/10.2196/jmir.3701 %U http://www.ncbi.nlm.nih.gov/pubmed/25092221 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 7 %P e177 %T A Web-Based Peer-Modeling Intervention Aimed at Lifestyle Changes in Patients With Coronary Heart Disease and Chronic Back Pain: Sequential Controlled Trial %A Schweier,Rebecca %A Romppel,Matthias %A Richter,Cynthia %A Hoberg,Eike %A Hahmann,Harry %A Scherwinski,Inge %A Kosmützky,Gregor %A Grande,Gesine %+ Faculty of Architecture and Social Sciences, University of Applied Sciences Leipzig (HTWK Leipzig), PF 301166, Leipzig, 04251, Germany, 49 341 3076 3203, schweier@sug.htwk-leipzig.de %K coronary artery disease %K lifestyle %K health behavior %K back pain %K personal narratives as topic %K Internet %K diet %K exercise %K Web-based intervention %D 2014 %7 23.07.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Traditional secondary prevention programs often fail to produce sustainable behavioral changes in everyday life. Peer-modeling interventions and integration of peer experiences in health education are a promising way to improve long-term effects in behavior modification. However, effects of peer support modeling on behavioral change have not been evaluated yet. Therefore, we implemented and evaluated a website featuring patient narratives about successful lifestyle changes. Objective: Our aim is to examine the effects of using Web-based patient narratives about successful lifestyle change on improvements in physical activity and eating behavior for patients with coronary heart disease and chronic back pain 3 months after participation in a rehabilitation program. Methods: The lebensstil-aendern (“lifestyle-change”) website is a nonrestricted, no-cost, German language website that provides more than 1000 video, audio, and text clips from interviews with people with coronary heart disease and chronic back pain. To test efficacy, we conducted a sequential controlled trial and recruited patients with coronary heart disease and chronic back pain from 7 inpatient rehabilitation centers in Germany. The intervention group attended a presentation on the website; the control group did not. Physical activity and eating behavior were assessed by questionnaire during the rehabilitation program and 12 weeks later. Analyses were conducted based on an intention-to-treat and an as-treated protocol. Results: A total of 699 patients were enrolled and 571 cases were included in the analyses (control: n=313, intervention: n=258; female: 51.1%, 292/571; age: mean 53.2, SD 8.6 years; chronic back pain: 62.5%, 357/571). Website usage in the intervention group was 46.1% (119/258). In total, 141 trial participants used the website. Independent t tests based on the intention-to-treat protocol only demonstrated nonsignificant trends in behavioral change related to physical activity and eating behavior. Multivariate regression analyses confirmed belonging to the intervention group was an independent predictor of self-reported improvements in physical activity regularity (β=.09, P=.03) and using less fat for cooking (β=.09, P=.04). In independent t tests based on the as-treated protocol, website use was associated with higher self-reported improvements in integrating physical activity into daily routine (d=0.22, P=.02), in physical activity regularity (d=0.23, P=.02), and in using less fat for cooking (d=0.21, P=.03). Multivariate regression analyses revealed that using the website at least 3 times was the only factor associated with improved lifestyle behaviors. Conclusions: Usage of the lebensstil-aendern website corresponds to more positive lifestyle changes. However, as-treated analyses do not allow for differentiating between causal effects and selection bias. Despite these limitations, the trial indicates that more than occasional website usage is necessary to reach dose-response efficacy. Therefore, future studies should concentrate on strategies to improve adherence to Web-based interventions and to encourage more frequent usage of these programs. %M 25057119 %R 10.2196/jmir.3434 %U http://www.jmir.org/2014/7/e177/ %U https://doi.org/10.2196/jmir.3434 %U http://www.ncbi.nlm.nih.gov/pubmed/25057119 %0 Journal Article %@ 2291-9279 %I JMIR Publications Inc. %V 2 %N 2 %P e8 %T What Serious Video Games Can Offer Child Obesity Prevention %A Thompson,Debbe %+ USDA/ARS Children's Nutrition Research Center, Pediatrics, Baylor College of Medicine, 1100 Bates Street, Houston, TX, 77030, United States, 1 713 798 7076, dit@bcm.edu %K serious video games %K children %K teenagers %K obesity prevention %K formative research, qualitative research %D 2014 %7 16.07.2014 %9 Viewpoint %J JMIR Serious Games %G English %X Childhood obesity is a worldwide issue, and effective methods encouraging children to adopt healthy diet and physical activity behaviors are needed. This viewpoint addresses the promise of serious video games, and why they may offer one method for helping children eat healthier and become more physically active. Lessons learned are provided, as well as examples gleaned from personal experiences. %M 25654589 %R 10.2196/games.3480 %U http://games.jmir.org/2014/2/e8/ %U https://doi.org/10.2196/games.3480 %U http://www.ncbi.nlm.nih.gov/pubmed/25654589 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 7 %P e173 %T Longitudinal Accuracy of Web-Based Self-Reported Weights: Results From the Hopkins POWER Trial %A Jerome,Gerald J %A Dalcin,Arlene %A Coughlin,Janelle W %A Fitzpatrick,Stephanie %A Wang,Nae-Yuh %A Durkin,Nowella %A Yeh,Hsin-Chieh %A Charleston,Jeanne %A Pozefsky,Thomas %A Daumit,Gail L %A Clark,Jeanne M %A Louis,Thomas A %A Appel,Lawrence J %+ Department of Kinesiology, Towson University, 8000 York Road, Towson, MD, 21252, United States, 1 410 704 5283, gjerome@towson.edu %K self-report %K weight loss %K obesity %K Internet %D 2014 %7 15.07.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Websites and phone apps are increasingly used to track weights during weight loss interventions, yet the longitudinal accuracy of these self-reported weights is uncertain. Objective: Our goal was to compare the longitudinal accuracy of self-reported weights entered online during the course of a randomized weight loss trial to measurements taken in the clinic. We aimed to determine if accuracy of self-reported weight is associated with weight loss and to determine the extent of misclassification in achieving 5% weight loss when using self-reported compared to clinic weights. Methods: This study examined the accuracy of self-reported weights recorded online among intervention participants in the Hopkins Practice-Based Opportunities for Weight Reduction (POWER) trial, a randomized trial examining the effectiveness of two lifestyle-based weight loss interventions compared to a control group among obese adult patients with at least one cardiovascular risk factor. One treatment group was offered telephonic coaching and the other group was offered in-person individual coaching and group sessions. All intervention participants (n=277) received a digital scale and were asked to track their weight weekly on a study website. Research staff used a standard protocol to measure weight in the clinic. Differences (self-reported weight – clinic weight) indicate if self-report under (-) or over (+) estimated clinic weight using the self-reported weight that was closest in time to the clinic weight and was within a window ranging from the day of the clinic visit to 7 days before the 6-month (n=225) and 24-month (n=191) clinic visits. The absolute value of the differences (absolute difference) describes the overall accuracy. Results: Underestimation of self-reported weights increased significantly from 6 months (mean -0.5kg, SD 1.0kg) to 24 months (mean -1.1kg, SD 2.0kg; P=.002). The average absolute difference also increased from 6 months (mean 0.7kg, SD 0.8kg) to 24 months (mean 1.3, SD 1.8kg; P<.001). Participants who achieved the study weight loss goal at 24 months (based on clinic weights) had lower absolute differences (P=.01) compared to those who did not meet this goal. At 24 months, there was 9% misclassification of weight loss goal success when using self-reported weight compared to clinic weight as an outcome. At 24 months, those with self-reported weights (n=191) had three times the weight loss compared to those (n=73) without self-reported weights (P<.001). Conclusions: Underestimation of weight increased over time and was associated with less weight loss. In addition to intervention adherence, weight loss programs should emphasize accuracy in self-reporting. Trial Registration: ClinicalTrials.gov: NCT00783315; http://clinicaltrials.gov/show/NCT00783315 (Archived by WebCite at http://www.webcitation.org/6R4gDAK5K). %M 25042773 %R 10.2196/jmir.3332 %U http://www.jmir.org/2014/7/e173/ %U https://doi.org/10.2196/jmir.3332 %U http://www.ncbi.nlm.nih.gov/pubmed/25042773 %0 Journal Article %@ 22915222 %I JMIR Publications Inc. %V 2 %N 3 %P e18 %T Development of an Evidence-Based mHealth Weight Management Program Using a Formative Research Process %A Waterlander,Wilma %A Whittaker,Robyn %A McRobbie,Hayden %A Dorey,Enid %A Ball,Kylie %A Maddison,Ralph %A Myers Smith,Katie %A Crawford,David %A Jiang,Yannan %A Gu,Yulong %A Michie,Jo %A Ni Mhurchu,Cliona %+ National Institute for Health Innovation, School of Population Health, University of Auckland, Tamaki Campus, Private Bag 92019, Auckland Mail Centre, Auckland, 1142, New Zealand, 64 (0)9 9234612, w.waterlander@nihi.auckland.ac.nz %K weight loss %K intervention %K Internet %K mobile phone %K focus groups %D 2014 %7 11.07.2014 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: There is a critical need for weight management programs that are effective, cost efficient, accessible, and acceptable to adults from diverse ethnic and socioeconomic backgrounds. mHealth (delivered via mobile phone and Internet) weight management programs have potential to address this need. To maximize the success and cost-effectiveness of such an mHealth approach it is vital to develop program content based on effective behavior change techniques, proven weight management programs, and closely aligned with participants’ needs. Objective: This study aims to develop an evidence-based mHealth weight management program (Horizon) using formative research and a structured content development process. Methods: The Horizon mHealth weight management program involved the modification of the group-based UK Weight Action Program (WAP) for delivery via short message service (SMS) and the Internet. We used an iterative development process with mixed methods entailing two phases: (1) expert input on evidence of effective programs and behavior change theory; and (2) target population input via focus group (n=20 participants), one-on-one phone interviews (n=5), and a quantitative online survey (n=120). Results: Expert review determined that core components of a successful program should include: (1) self-monitoring of behavior; (2) prompting intention formation; (3) promoting specific goal setting; (4) providing feedback on performance; and (5) promoting review of behavioral goals. Subsequent target group input confirmed that participants liked the concept of an mHealth weight management program and expressed preferences for the program to be personalized, with immediate (prompt) and informative text messages, practical and localized physical activity and dietary information, culturally appropriate language and messages, offer social support (group activities or blogs) and weight tracking functions. Most target users expressed a preference for at least one text message per day. We present the prototype mHealth weight management program (Horizon) that aligns with those inputs. Conclusions: The Horizon prototype described in this paper could be used as a basis for other mHealth weight management programs. The next priority will be to further develop the program and conduct a full randomized controlled trial of effectiveness. %M 25098337 %R 10.2196/mhealth.2850 %U http://www.jmir.org/2014/3/e18/ %U https://doi.org/10.2196/mhealth.2850 %U http://www.ncbi.nlm.nih.gov/pubmed/25098337 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 7 %P e170 %T The Role of Facebook in Crush the Crave, a Mobile- and Social Media-Based Smoking Cessation Intervention: Qualitative Framework Analysis of Posts %A Struik,Laura Louise %A Baskerville,Neill Bruce %+ Faculty of Health and Social Development, School of Nursing, University of British Columbia's Okanagan Campus, ART 360, 3333 University Way, Kelowna, BC, V1V1V7, Canada, 1 2508647879, laurastruik134@hotmail.com %K qualitative research %K young adult %K smoking cessation %K Internet %K social media %D 2014 %7 11.07.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Social networking sites, particularly Facebook, are increasingly included in contemporary smoking cessation interventions directed toward young adults. Little is known about the role of Facebook in smoking cessation interventions directed toward this age demographic. Objective: The aim of this study was to characterize the content of posts on the Facebook page of Crush the Crave, an evidence-informed smoking cessation intervention directed toward young adults aged 19 to 29 years. Methods: Crush the Crave Facebook posts between October 10, 2012 and June 12, 2013 were collected for analysis, representing page activity during the pilot phase of Crush the Crave. Of the 399 posts included for analysis, 121 were original posts, whereas the remaining 278 were reply posts. Posts were coded according to themes using framework analysis. Results: We found that the original Crush the Crave Facebook posts served two main purposes: to support smoking cessation and to market Crush the Crave. Most of the original posts (86/121, 71.1%) conveyed support of smoking cessation through the following 7 subthemes: encouraging cessation, group stimulation, management of cravings, promoting social support, denormalizing smoking, providing health information, and exposing tobacco industry tactics. The remaining original posts (35/121, 28.9%) aimed to market Crush the Crave through 2 subthemes: Crush the Crave promotion and iPhone 5 contest promotion. Most of the reply posts (214/278, 77.0%) were in response to the supporting smoking cessation posts and the remaining 64 (23.0%) were in response to the marketing Crush the Crave posts. The most common response to both the supporting smoking cessation and marketing Crush the Crave posts was user engagement with the images associated with each post at 40.2% (86/214) and 45% (29/64), respectively. The second most common response consisted of users sharing their smoking-related experiences. More users shared their smoking-related experiences in response to the supporting smoking cessation posts (81/214, 37.9%) compared to the marketing Crush the Crave posts (11/64, 17%). With the exception of 4 posts, a moderator posted all the original posts. In addition, although 56.00% (18,937/33,815) of Crush the Crave Facebook page users were men, only 19.8% (55/278) of the reply posts were made by men. Finally, men were found to be more likely to express sarcasm or make strong assertions about quitting smoking and Crush the Crave than women. Conclusions: The CTC Facebook page presents as a unique platform for supporting young adult smoking cessation at all stages of the cessation process. The findings of this study indicate that social networking sites, especially Facebook, warrant inclusion in tobacco control efforts directed towards young adults. Research on effectiveness of the Facebook page for quitting smoking is needed. %M 25016998 %R 10.2196/jmir.3189 %U http://www.jmir.org/2014/7/e170/ %U https://doi.org/10.2196/jmir.3189 %U http://www.ncbi.nlm.nih.gov/pubmed/25016998 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 7 %P e168 %T Long-Term Results of a Web-Based Guided Self-Help Intervention for Employees With Depressive Symptoms: Randomized Controlled Trial %A Geraedts,Anna S %A Kleiboer,Annet M %A Twisk,Jos %A Wiezer,Noortje M %A van Mechelen,Willem %A Cuijpers,Pim %+ Department of Clinical Psychology, Vrije University Amsterdam, Van der Boechorststraat 1, Amsterdam, 1081 BT, Netherlands, 31 0205987451, a.s.geraedts@vu.nl %K depression %K employees %K occupational intervention %K self-help %K prevention %K burnout %K Internet %D 2014 %7 09.07.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Depressive disorders are highly prevalent in the working population and are associated with excessive costs. The evidence for effective worker-directed interventions for employees with depressive symptoms is limited. Treating employees with depressive symptoms via the Internet before they report sick from work could be beneficial and cost saving. Objective: In this study, we tested the effectiveness over the period of 1 year of a Web-based guided self-help intervention, called Happy@Work, for employees with depressive symptoms who were not on sick leave. Methods: A two-arm randomized controlled trial comparing a worker-directed, Web-based, guided self-help intervention to care as usual (CAU) was carried out. We recruited employees from 6 companies via the company’s Intranet and by putting up posters. The inclusion criteria were elevated depressive symptoms as measured by a score ≥16 on the Center for Epidemiologic Studies Depression scale (CES-D) and not being on sick leave. The intervention contained 6 lessons and consisted of problem-solving treatment and cognitive therapy. Participants were asked to submit weekly assignments via the website after completion of a lesson and they received feedback from a coach via the website. Self-report questionnaires on depressive symptoms (CES-D; primary outcome), burnout (Maslach Burnout Inventory, MBI), work performance (Health and Work Performance Questionnaire, HPQ), duration of absenteeism, and anxiety (Hospital Anxiety and Depression Scale, HADS; secondary outcomes), were completed at baseline, posttreatment, and at 6-, and 12-month follow-up. Several subgroup and per-protocol analyses were performed. Results: A total of 231 employees were randomized to either the intervention group (n=116) or to CAU (n=115). Completion of assessments varied between 54%-74%. Improvement in depressive symptoms between baseline and posttreatment was shown in all participants and these effects sustained over time. However, there were no differences between the 2 groups (adjusted regression coefficient=0.46, 95% CI –2.11 to 3.03, P=.72; Cohen’s d=0.05). Differences between groups were also not significant for the secondary outcomes. No subgroups were identified to show differences between the groups, nor did we find a between-group effect in the per-protocol analyses. Conclusions: This study showed that a worker-directed, Web-based, guided self-help intervention was not more effective than CAU in reducing depressive symptoms among employees with depressive symptoms who were not on sick leave over the period of 1 year. An intervention for this specific target group might not be necessary because the recovery in the CAU group was comparable to the intervention group and sustained over a 12-month period. Trial Registration: Nederlands Trial Register (NTR): NTR2993; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2993 (Archived by WebCite at http://www.webcitation.org/6PL9pFC0n). %M 25008127 %R 10.2196/jmir.3539 %U http://www.jmir.org/2014/7/e168/ %U https://doi.org/10.2196/jmir.3539 %U http://www.ncbi.nlm.nih.gov/pubmed/25008127 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 7 %P e166 %T Assessing the Applicability of E-Therapies for Depression, Anxiety, and Other Mood Disorders Among Lesbians and Gay Men: Analysis of 24 Web- and Mobile Phone-Based Self-Help Interventions %A Rozbroj,Tomas %A Lyons,Anthony %A Pitts,Marian %A Mitchell,Anne %A Christensen,Helen %+ Australian Research Centre in Sex, Health and Society, Faculty of Health Sciences, La Trobe University, 215, Franklin Street, Melbourne, 3000, Australia, 61 3 9479 8765, t.rozbroj@latrobe.edu.au %K Internet therapy %K e-therapy %K cCBT %K mental health %K gay men %K lesbian %K minority stress %K depression %K anxiety %K review %D 2014 %7 03.07.2014 %9 Review %J J Med Internet Res %G English %X Background: Lesbians and gay men have disproportionately high rates of depression and anxiety, and report lower satisfaction with treatments. In part, this may be because many health care options marginalize them by assuming heterosexuality, or misunderstand and fail to respond to the challenges specifically faced by these groups. E-therapies have particular potential to respond to the mental health needs of lesbians and gay men, but there is little research to determine whether they do so, or how they might be improved. Objective: We sought to examine the applicability of existing mental health e-therapies for lesbians and gay men. Methods: We reviewed 24 Web- and mobile phone-based e-therapies and assessed their performance in eight key areas, including the use of inclusive language and content and whether they addressed mental health stressors for lesbians and gay men, such as experiences of stigma related to their sexual orientation, coming out, and relationship issues that are specific to lesbians and gay men. Results: We found that e-therapies seldom addressed these stressors. Furthermore, 58% (14/24) of therapies contained instances that assumed or suggested the user was heterosexual, with instances especially prevalent among better-evidenced programs. Conclusions: Our findings, and a detailed review protocol presented in this article, may be used as guides for the future development of mental health e-therapies to better accommodate the needs of lesbians and gay men. %M 24996000 %R 10.2196/jmir.3529 %U http://www.jmir.org/2014/7/e166/ %U https://doi.org/10.2196/jmir.3529 %U http://www.ncbi.nlm.nih.gov/pubmed/24996000 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 7 %P e163 %T The Effectiveness of Loyalty Rewards to Promote the Use of an Internet-Based Heart Health Program %A Liu,Sam %A Hodgson,Corinne %A Zbib,Ahmad M %A Payne,Ada YM %A Nolan,Robert P %+ Cardiac eHealth Research Unit, Peter Munk Cardiac Center, University Health Network, Room 6N-618 NU, 585 University Avenue, Toronto, ON, M5G 2C4, Canada, 1 416 340 4800 ext 6400, rnolan@uhnres.utoronto.ca %K Internet %K cardiovascular risk %K prevention %K rewards %D 2014 %7 02.07.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-based health programs have been shown to be effective in reducing risk for cardiovascular disease. However, their rates of enrollment and engagement remain low. It is currently unclear whether rewards from established loyalty programs can serve as a conditioned stimulus to improve the use of a freely available Internet-based program. Objective: The objectives of the study were to (1) examine enrollment rates and levels of engagement with the My Health eSupport program between a Conditioned Reward group and a Control group, and (2) investigate the influence of loyalty rewards and participant characteristics on levels of enrollment and program engagement. Methods: The study sample (n=142,726) consisted of individuals who were offered enrollment in an Internet-based health intervention (My Health eSupport) after completing the Heart&Stroke Risk Assessment on the Heart and Stroke Foundation website. My Health eSupport programs provided encouragement and tips for lifestyle change. This is a free, self-guided, fully automated program that proactively delivers tailored email messages at 2-week intervals based on the participant’s stage of motivational “readiness” and priority for lifestyle change. Participants in the Conditioned Reward group were offered a single exposure of 20 loyalty reward points from the Air Miles loyalty program for completing the Heart&Stroke Risk Assessment (10 reward points) and enrolling in the Internet-based program (10 reward points). Meanwhile, no rewards were given to the Control group participants. All data were collected between February 1, 2011 and February 10, 2012. Results: In total, 51.38% (73,327/142,726) of individuals in the Conditioned Reward group and 48.62% (69,399/142,726) of individuals in the Control group completed the Heart&Stroke Risk Assessment. Subsequently, significantly more individuals from the Conditioned Reward group (52.96%, 38,835/73,327) enrolled in the My Health eSupport program than Controls (4.07%, 2826/69,399). Regression analyses indicated that individuals were 27.9 times (95% CI 26.4-29.4; P<.001) more likely to join the My Health eSupport program when presented with loyalty rewards controlling for gender, age, education, ethnicity, employment, and number of modifiable risk factors. However, ongoing engagement level was low in both groups and it was not influenced by loyalty rewards. Instead, individuals were more likely to engage with the My Health eSupport program if they were greater than 60 years of age (OR 12.56, 95% CI 5.66-27.8; P<.001), were female (OR 1.27, 95% CI 1.09-1.46; P=.002), or had one or more modifiable risk factors (OR 1.38, 95% CI 1.31-1.45; P<.001). Conclusions: Our findings suggest that a single exposure of loyalty rewards may be used to encourage individuals to enroll in an Internet-based preventative health program, but additional strategies are required to maintain engagement level. Future studies need to examine the schedules of loyalty reward reinforcement on the long-term engagement level of Internet-based health programs. %M 24989982 %R 10.2196/jmir.3458 %U http://www.jmir.org/2014/7/e163/ %U https://doi.org/10.2196/jmir.3458 %U http://www.ncbi.nlm.nih.gov/pubmed/24989982 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 2 %N 2 %P e29 %T Exploring the Usability of a Mobile App for Adolescent Obesity Management %A O'Malley,Grace %A Dowdall,Grainne %A Burls,Amanda %A Perry,Ivan J %A Curran,Noirin %+ Department of Physiotherapy, Temple Street Children’s University Hospital, Temple Street, Dublin, Ireland, 353 1 8921838, omalleyg@tcd.ie %K obesity %K mobile health %K usability testing %K adolescent %K participatory health care %D 2014 %7 27.06.2014 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: Obesity is a global epidemic. Behavioral change approaches towards improving nutrition, increasing physical activity level, improving sleep, and reducing sitting time are recommended as best practices in adolescent obesity management. However, access to evidence-based treatment is limited and portable technologies such as mobile apps may provide a useful platform to deliver such lifestyle interventions. No evidence-based validated app exists for obesity intervention; therefore, a novel mobile app (Reactivate) was developed for use in the Temple Street W82GO Healthy Lifestyles Program (W82GO). Objective: This study aimed to test the usability (technical effectiveness, efficiency, and user satisfaction) of the Reactivate mobile app in obese adolescents. Methods: Ten adolescents (7 males and 3 females, aged 12-17 years) who had been treated for obesity (>98th percentile for body mass index) at the Temple Street Children's University Hospital were recruited. Participants were given 8 tasks to complete in order to test the technical effectiveness of the app. A research assistant timed the user while completing each task in order to test the relative user efficiency of the app (time-on-task). The tasks fell into 5 categories and required the user to enter personal settings, find and answer surveys, create a message, use the goal setting feature, and enter details regarding their weight and height. In exploration of user satisfaction, each participant completed the standardized software usability measurement inventory (SUMI), which measures 5 aspects of user satisfaction: efficiency, effect, helpfulness, controllability, and learnability. Descriptive statistics were used to explore the mean relative user efficiency and SUMI scores. Results: Mean age was 14.26 (SD 1.58) years. All adolescents completed each of the tasks successfully. The mean relative user efficiency scores were two to three times that of an expert user. Users responded that they would use Reactivate to monitor their growth over time, for motivation, and for goal setting. All users described Reactivate as an important mobile app. Conclusions: Our study describes the usability of a mobile app used in adolescent obesity management. Adolescents found Reactivate easy to use and their SUMI results indicated that the app scored high on user satisfaction. Usability testing is an important step towards refining the development of the Reactivate app, which can be used in the treatment of obesity. The study on the clinical efficacy of the Reactivate app is currently underway. %M 25098237 %R 10.2196/mhealth.3262 %U http://mhealth.jmir.org/2014/2/e29/ %U https://doi.org/10.2196/mhealth.3262 %U http://www.ncbi.nlm.nih.gov/pubmed/25098237 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 6 %P e159 %T Tablet-Based Strength-Balance Training to Motivate and Improve Adherence to Exercise in Independently Living Older People: Part 2 of a Phase II Preclinical Exploratory Trial %A van het Reve,Eva %A Silveira,Patrícia %A Daniel,Florian %A Casati,Fabio %A de Bruin,Eling D %+ Institute of Human Movement Sciences and Sport, Department of Health Sciences and Technology, ETH Zurich, HIT J31.2, Wolfgang-Pauli-Strasse 27, Zurich, 8093, Switzerland, 41 44 632 4018, eva.vanhetreve@hest.ethz.ch %K gait %K aging %K exercise therapy %K tablet %K delivery of health care %D 2014 %7 25.06.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Home-based exercise programs can improve physical functioning and health status of elderly people. Successful implementation of exercise interventions for older people presents major challenges and supporting elderly people properly while doing their home-based exercises is essential for training success. We developed a tablet-based system—ActiveLifestyle—that offers older adults a home-based strength-balance training program with incorporated motivation strategies and support features. Objective: The goal was to compare 3 different home-based training programs with respect to their effect on measures of gait quality and physical performance through planned comparisons between (1) tablet-based and brochure-based interventions, (2) individual and social motivation strategies, and (3) active and inactive participants. Methods: A total of 44 autonomous-living elderly people (mean 75, SD 6 years) were assigned to 3 training groups: social (tablet guided, n=14), individual (tablet guided, n=13), and brochure (brochure guided, n=17). All groups joined a 12-week progressive home-based strength-balance training program. Outcome measures were gait performance under single and dual task conditions, dual task costs of walking, falls efficacy, and physical performance as measured by the Short Physical Performance Battery (SPPB). Furthermore, active (≥75% program compliance) and inactive (<75% program compliance) individuals were compared based on their characteristics and outcome measures. Results: The tablet groups showed significant improvements in single and dual task walking, whereas there were no significant changes observable in the brochure group. Between-groups comparisons revealed significant differences for gait velocity (U=138.5; P=.03, r=.33) and cadence (U=138.5, P=.03 r=.34) during dual task walking at preferred speed in favor of the tablet groups. The brochure group had more inactive participants, but this did not reach statistical significance (U=167, P=.06, r=.29). The active participants outperformed the inactive participants in single and dual task walking, dual task costs of walking, and SPPB scores. Significant between-groups differences were seen between the tablet groups and the brochure group, in favor of the tablet groups. Conclusions: A tablet-based strength-balance training program that allows monitoring and assisting autonomous-living older adults while training at home was more effective in improving gait and physical performance when compared to a brochure-based program. Social or individual motivation strategies were equally effective. The most prominent differences were observed between active and inactive participants. These findings suggest that in older adults a tablet-based intervention enhances training compliance; hence, it is an effective way to improve gait. %M 24966165 %R 10.2196/jmir.3055 %U http://www.jmir.org/2014/6/e159/ %U https://doi.org/10.2196/jmir.3055 %U http://www.ncbi.nlm.nih.gov/pubmed/24966165 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 6 %P e158 %T Click “Like” to Change Your Behavior: A Mixed Methods Study of College Students’ Exposure to and Engagement With Facebook Content Designed for Weight Loss %A Merchant,Gina %A Weibel,Nadir %A Patrick,Kevin %A Fowler,James H %A Norman,Greg J %A Gupta,Anjali %A Servetas,Christina %A Calfas,Karen %A Raste,Ketaki %A Pina,Laura %A Donohue,Mike %A Griswold,William G %A Marshall,Simon %+ Center for Wireless and Population Health Systems, The Qualcomm Institute/Calit2, Department of Family and Preventive Medicine, University of California San Diego, Center for Wireless and Population Health Systems, Calit2, 6th Floor, Room 6105, 9500 Gilman Drive #0436, La Jolla, CA, , United States, 1 858 246 1371, gmerchant@ucsd.edu %K overweight %K obesity %K students %K social networking %K behavior %K social behavior %D 2014 %7 24.06.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Overweight or obesity is prevalent among college students and many gain weight during this time. Traditional face-to-face weight loss interventions have not worked well in this population. Facebook is an attractive tool for delivering weight loss interventions for college students because of its popularity, potential to deliver strategies found in successful weight loss interventions, and ability to support ongoing adaptation of intervention content. Objective: The objective of this study was to describe participant exposure to a Facebook page designed to deliver content to overweight/obese college students in a weight loss randomized controlled trial (N=404) and examine participant engagement with behavior change campaigns for weight loss delivered via Facebook. Methods: The basis of the intervention campaign model were 5 self-regulatory techniques: intention formation, action planning, feedback, goal review, and self-monitoring. Participants were encouraged to engage their existing social network to meet their weight loss goals. A health coach moderated the page and modified content based on usage patterns and user feedback. Quantitative analyses were conducted at the Facebook post- and participant-level of analysis. Participant engagement was quantified by Facebook post type (eg, status update) and interaction (eg, like) and stratified by weight loss campaign (sequenced vs nonsequenced). A subset of participants were interviewed to evaluate the presence of passive online engagement or “lurking.” Results: The health coach posted 1816 unique messages to the study’s Facebook page over 21 months, averaging 3.45 posts per day (SD 1.96, range 1-13). In all, 72.96% (1325/1816) of the posts were interacted with at least once (eg, liked). Of these, approximately 24.75% (328/1325) had 1-2 interactions, 23.39% (310/1325) had 3-5 interactions, 25.13% (333/1325) had 6-8 interactions, and 41 posts had 20 or more interactions (3.09%, 41/1325). There was significant variability among quantifiable (ie, visible) engagement. Of 199 participants in the final intervention sample, 32 (16.1%) were highly active users and 62 (31.2%) never visibly engaged with the intervention on Facebook. Polls were the most popular type of post followed by photos, with 97.5% (79/81) and 80.3% (386/481) interacted with at least once. Participants visibly engaged less with posts over time (partial r=–.33; P<.001). Approximately 40% of the participants interviewed (12/29, 41%) reported passively engaging with the Facebook posts by reading but not visibly interacting with them. Conclusions: Facebook can be used to remotely deliver weight loss intervention content to college students with the help of a health coach who can iteratively tailor content and interact with participants. However, visible engagement with the study’s Facebook page was highly variable and declined over time. Whether the level of observed engagement is meaningful in terms of influencing changes in weight behaviors and outcomes will be evaluated at the completion of the overall study. %M 24964294 %R 10.2196/jmir.3267 %U http://www.jmir.org/2014/6/e158/ %U https://doi.org/10.2196/jmir.3267 %U http://www.ncbi.nlm.nih.gov/pubmed/24964294 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 2 %N 2 %P e30 %T Feasibility and User Perception of a Fully Automated Push-Based Multiple-Session Alcohol Intervention for University Students: Randomized Controlled Trial %A Bendtsen,Marcus %A Bendtsen,Preben %+ Medical Faculty, Department of Medical Specialist and Department of Medicine and Health, Linköping University, Motala, Linköping, 581 83, Sweden, 46 702324615, preben.bendtsen@liu.se %K alcohol intervention %K text messages %K SMS %K email %K students %K multiple-session intervention %K push-based intervention %D 2014 %7 23.06.2014 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: In recent years, many electronic health behavior interventions have been developed in order to reach individuals with unhealthy behaviors, such as risky drinking. This is especially relevant for university students, many of whom are risky drinkers. Objective: This study explored the acceptability and feasibility in a nontreatment-seeking group of university students (including both risk and nonrisk drinkers), of a fully automated, push-based, multiple-session, alcohol intervention, comparing two modes of delivery by randomizing participants to receive the intervention either by SMS text messaging (short message service, SMS) or by email. Methods: A total of 5499 students at Luleå University in northern Sweden were invited to participate in a single-session alcohol assessment and feedback intervention; 28.04% (1542/5499) students completed this part of the study. In total, 29.44% (454/1542) of those participating in the single-session intervention accepted to participate further in the extended multiple-session intervention lasting for 4 weeks. The students were randomized to receive the intervention messages via SMS or email. A follow-up questionnaire was sent immediately after the intervention and 52.9% (240/454) responded. Results: No difference was seen regarding satisfaction with the length and frequency of the intervention, regardless of the mode of delivery. Approximately 15% in both the SMS (19/136) and email groups (15/104) would have preferred the other mode of delivery. On the other hand, more students in the SMS group (46/229, 20.1%) stopped participating in the intervention during the 4-week period compared with the email group (10/193, 5.2%). Most students in both groups expressed satisfaction with the content of the messages and would recommend the intervention to a fellow student in need of reducing drinking. A striking difference was seen regarding when a message was read; 88.2% (120/136) of the SMS group read the messages within 1 hour in contrast to 45.2% (47/104) in the email group. In addition, 83.1% (113/136) in the SMS group stated that they read all or almost all the messages, compared with only 63.5% (66/104) in the email group. Conclusions: Based on the feedback from the students, an extended, multiple-session, push-based intervention seems to be a feasible option for students interested in additional support after a single-session alcohol intervention. SMS as a mode of delivery seems to have some advantages over email regarding when a message is read and the proportion of messages read. However, more students in the SMS group stopped the intervention than in the email group. Based on these promising findings, further studies comparing the effectiveness of single-session interventions with extended multiple-session interventions delivered separately or in combination are warranted. %M 25098296 %R 10.2196/mhealth.3233 %U http://mhealth.jmir.org/2014/2/e30/ %U https://doi.org/10.2196/mhealth.3233 %U http://www.ncbi.nlm.nih.gov/pubmed/25098296 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 6 %P e156 %T Evaluation of an eHealth Intervention in Chronic Care for Frail Older People: Why Adherence is the First Target %A Makai,Peter %A Perry,Marieke %A Robben,Sarah HM %A Schers,Henk J %A Heinen,Maud M %A Olde Rikkert,Marcel GM %A Melis,René F %+ Radboud University Medical Center, Department of Geriatrics, Renier Postlaan 4, Nijmegen, 6500 HB, Netherlands, 31 24 361 98 07, Peter.Makai@radboudumc.nl %K eHealth %K frail elderly %K care coordination %K chronic care %D 2014 %7 23.06.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Older people suffering from frailty often receive fragmented chronic care from multiple professionals. According to the literature, there is an urgent need for coordination of care. Objective: The objective of this study was to investigate the effectiveness of an online health community (OHC) intervention for older people with frailty aimed at facilitating multidisciplinary communication. Methods: The design was a controlled before-after study with 12 months follow-up in 11 family practices in the eastern part of the Netherlands. Participants consisted of frail older people living in the community requiring multidisciplinary (long-term) care. The intervention used was the health and welfare portal (ZWIP): an OHC for frail elderly patients, their informal caregivers and professionals. ZWIP contains a secure messaging system supplemented by a shared electronic health record. Primary outcomes were scores on the Instrumental Activities of Daily Living scale (IADL), mental health, and social activity limitations. Results: There were 290 patients in the intervention group and 392 in the control group. Of these, 76/290 (26.2%) in the intervention group actively used ZWIP. After 12 months follow-up, we observed no significant improvement on primary patient outcomes. ADL improved in the intervention group with a standardized score of 0.21 (P=.27); IADL improved with 0.50 points, P=.64. Conclusions: Only a small percentage of frail elderly people in the study intensively used ZWIP, our newly developed and innovative eHealth tool. The use of this OHC did not significantly improve patient outcomes. This was most likely due to the limited use of the OHC, and a relatively short follow-up time. Increasing actual use of eHealth intervention seems a precondition for large-scale evaluation, and earlier adoption before frailty develops may improve later use and effectiveness of ZWIP. %M 24966146 %R 10.2196/jmir.3057 %U http://www.jmir.org/2014/6/e156/ %U https://doi.org/10.2196/jmir.3057 %U http://www.ncbi.nlm.nih.gov/pubmed/24966146 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 2 %P e30 %T The Cost Effectiveness of a Tailored, Web-Based Care Program to Enhance Postoperative Recovery in Gynecologic Patients in Comparison With Usual Care: Protocol of a Stepped Wedge Cluster Randomized Controlled Trial %A Bouwsma,Esther VA %A Anema,Johannes R %A Vonk Noordegraaf,Antonie %A Knol,Dirk L %A Bosmans,Judith E %A Schraffordt Koops,Steven E %A van Kesteren,Paul JM %A van Baal,W Marchien %A Lips,Jos P %A Emanuel,Mark H %A Scholten,Petrus C %A Mozes,Alexander %A Adriaanse,Albert H %A Brölmann,Hans AM %A Huirne,Judith AF %+ Department of Obstetrics and Gynecology, VU University Medical Center, De Boelelaan 1117, Amsterdam, , Netherlands, 31 20444 4827, j.huirne@vumc.nl %K gynecology %K Internet %K telemedicine %K convalescence %K return to work %K economic evaluation %D 2014 %7 18.06.2014 %9 Protocol %J JMIR Res Protoc %G English %X Background: The length of recovery after benign gynecological surgery and return to work frequently exceeds the period that is recommended or expected by specialists. A prolonged recovery is associated with a poorer quality of life. In addition, costs due to prolonged sick leave following gynecological surgery cause a significant financial burden on society. Objective: The objective of our study was to present the protocol of a stepped wedge cluster randomized controlled trial to evaluate the cost effectiveness of a new care program for patients undergoing hysterectomy and/or adnexal surgery for benign disease, compared to the usual care. Methods: The care program under study, designed to improve convalescence and to prevent delayed return to work, targets two levels. At the hospital level, guidelines will be distributed among clinical staff in order to stimulate evidence-based patient education. At the patient level, additional perioperative guidance is provided by means of an eHealth intervention, equipping patients with tailored convalescence advice, and an occupational intervention is available for those patients at risk of prolonged sick leave. Due to the stepped wedge design of the trial, the care program will be sequentially rolled out among the 9 participating hospitals, from which the patients are recruited. Eligible for this study are employed women, 18-65 years of age, who are scheduled for hysterectomy and/or laparoscopic adnexal surgery. The primary outcome is full sustainable return to work. The secondary outcomes include general recovery, quality of life, self-efficacy, coping, and pain. The data will be collected by means of self-reported electronic questionnaires before surgery and at 2, 6, 12, 26, and 52 weeks after surgery. Sick leave and cost data are measured by monthly sick leave calendars, and cost diaries during the 12 month follow-up period. The economic evaluation will be performed from the societal perspective. All statistical analyses will be conducted according to the intention-to-treat principle. Results: The enrollment of the patients started October 2011. The follow-up period will be completed in August 2014. Data cleaning or analysis has not begun as of this article’s submission. Conclusions: We hypothesize the care program to be effective by means of improving convalescence and reducing costs associated with productivity losses following gynecological surgery. The results of this study will enable health care policy makers to decide about future implementation of this care program on a broad scale. Trial Registration: Netherlands Trial Register: NTR2933; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2933 (Archived by WebCite at http://www.webcitation.org/6Q7exPG84). %M 24943277 %R 10.2196/resprot.3236 %U http://www.researchprotocols.org/2014/2/e30/ %U https://doi.org/10.2196/resprot.3236 %U http://www.ncbi.nlm.nih.gov/pubmed/24943277 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 6 %P e152 %T Pretreatment Attrition and Formal Withdrawal During Treatment and Their Predictors: An Exploratory Study of the Anxiety Online Data %A AL-Asadi,Ali M %A Klein,Britt %A Meyer,Denny %+ Department of Arts and Education, Grande Prairie Regional College, 10726 - 106 Ave, Grande Prairie, AB, T8V 4C4, Canada, 1 780 539 2061, aalasadi@gprc.ab.ca %K pretreatment attrition %K treatment withdrawal dropouts %K predictors, anxiety disorders %K eTherapy %K e-mental health %K Internet interventions %D 2014 %7 17.06.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Although in its infancy, the field of e-mental health interventions has been gaining popularity and afforded considerable research attention. However, there are many gaps in the research. One such gap is in the area of attrition predictors at various stages of assessment and treatment delivery. Objective: This exploratory study applied univariate and multivariate analysis to a large dataset provided by the Anxiety Online (now called Mental Health Online) system to identify predictors of attrition in treatment commencers and in those who formally withdrew during treatment based on 24 pretreatment demographic and personal variables and one clinical measure. Methods: Participants were assessed using a complex online algorithm that resulted in primary and secondary diagnoses in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR). Those who received a primary or secondary diagnosis of 1 of 5 anxiety disorders (generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder, and panic disorder) were offered an online 12-week disorder-specific treatment program. Results: Of 9394 potential participants, a total of 3880 clients enrolled and 5514 did not enroll in one of the treatment programs following the completion of pretreatment assessment measures (pretreatment attrition rate: 58.70%). A total of 3199 individuals did not formally withdraw from the 12-week treatment cycle, whereas 142 individuals formally dropped out (formal withdrawal during treatment dropout rate of 4.25%). The treatment commencers differed significantly (P<.001-.03) from the noncommencers on several variables (reason for registering, mental health concerns, postsecondary education, where first heard about Anxiety Online, Kessler-6 score, stage of change, quality of life, relationship status, preferred method of learning, and smoking status). Those who formally withdrew during treatment differed significantly (P=.002-.03) from those who did not formally withdraw in that they were less likely to express concerns about anxiety, stress, and depression; to rate their quality of life as very poor, poor, or good; to report adequate level of social support; and to report readiness to make or were in the process of making changes. Conclusions: This exploratory study identified predictors of pretreatment attrition and formal withdrawal during treatment dropouts for the Anxiety Online program. Trial Registration: Australian and New Zealand Clinical Trials Registry ACTRN121611000704998; http://www.anzctr.org.au/trial_view.aspx?ID=336143 (Archived by WebCite at http://www.webcitation.org/618r3wvOG). %M 24938311 %R 10.2196/jmir.2989 %U http://www.jmir.org/2014/6/e152/ %U https://doi.org/10.2196/jmir.2989 %U http://www.ncbi.nlm.nih.gov/pubmed/24938311 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 6 %P e153 %T Online Social Networks That Connect Users to Physical Activity Partners: A Review and Descriptive Analysis %A Nakhasi,Atul %A Shen,Album Xiaotian %A Passarella,Ralph Joseph %A Appel,Lawrence J %A Anderson,Cheryl AM %+ School of Medicine, Department of Family and Preventive Medicine, University of California, San Diego, 9500 Gilman Drive, MC-0725, La Jolla, CA, 92093, United States, 1 8585344456, c1anderson@ucsd.edu %K behavior %K behavior control %K behavioral research %K exercise %K health %K health behavior %K information services %K Internet %K intervention studies %K online systems %K physical fitness %K social media %K social medicine %K social networking %K social support %K telemedicine %K Web %D 2014 %7 16.06.2014 %9 Review %J J Med Internet Res %G English %X Background: The US Centers for Disease Control and Prevention have identified a lack of encouragement, support, or companionship from family and friends as a major barrier to physical activity. To overcome this barrier, online social networks are now actively leveraging principles of companion social support in novel ways. Objective: The aim was to evaluate the functionality, features, and usability of existing online social networks which seek to increase physical activity and fitness among users by connecting them to physical activity partners, not just online, but also face-to-face. Methods: In September 2012, we used 3 major databases to identify the website addresses for relevant online social networks. We conducted a Google search using 8 unique keyword combinations: the common keyword “find” coupled with 1 of 4 prefix terms “health,” “fitness,” “workout,” or “physical” coupled with 1 of 2 stem terms “activity partners” or “activity buddies.” We also searched 2 prominent technology start-up news sites, TechCrunch and Y Combinator, using 2 unique keyword combinations: the common keyword “find” coupled with 1 of 2 stem terms “activity partners” and “activity buddies.” Sites were defined as online social health activity networks if they had the ability to (1) actively find physical activity partners or activities for the user, (2) offer dynamic, real-time tracking or sharing of social activities, and (3) provide virtual profiles to users. We excluded from our analysis sites that were not Web-based, publicly available, in English, or free. Results: Of the 360 initial search results, we identified 13 websites that met our complete criteria of an online social health activity network. Features such as physical activity creation (13/13, 100%) and private messaging (12/13, 92%) appeared almost universally among these websites. However, integration with Web 2.0 technologies such as Facebook and Twitter (9/13, 69%) and the option of direct event joining (8/13, 62%) were not as universally present. Largely absent were more sophisticated features that would enable greater usability, such as interactive engagement prompts (3/13, 23%) and system-created best fit activities (3/13, 23%). Conclusions: Several major online social networks that connect users to physical activity partners currently exist and use standardized features to achieve their goals. Future research is needed to better understand how users utilize these features and how helpful they truly are. %M 24936569 %R 10.2196/jmir.2674 %U http://www.jmir.org/2014/6/e153/ %U https://doi.org/10.2196/jmir.2674 %U http://www.ncbi.nlm.nih.gov/pubmed/24936569 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 6 %P e136 %T Effectiveness of a Web- and Mobile Phone-Based Intervention to Promote Physical Activity and Healthy Eating in Middle-Aged Males: Randomized Controlled Trial of the ManUp Study %A Duncan,Mitch %A Vandelanotte,Corneel %A Kolt,Gregory S %A Rosenkranz,Richard R %A Caperchione,Cristina M %A George,Emma S %A Ding,Hang %A Hooker,Cindy %A Karunanithi,Mohan %A Maeder,Anthony J %A Noakes,Manny %A Tague,Rhys %A Taylor,Pennie %A Viljoen,Pierre %A Mummery,W Kerry %+ School of Medicine & Public Health, Priority Research Centre in Physical Activity and Nutrition, Faculty of Health and Medicine, University of Newcastle, ATC Building, University Drive, University of Newcastle, Newcastle, 2300, Australia, 61 0249215215, Mitch.Duncan@newcastle.edu.au %K physical activity %K diet %K mobile phone %K Web-based %K randomized controlled trial %D 2014 %7 12.06.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: The high number of adult males engaging in low levels of physical activity and poor dietary practices, and the health risks posed by these behaviors, necessitate broad-reaching intervention strategies. Information technology (IT)-based (Web and mobile phone) interventions can be accessed by large numbers of people, yet there are few reported IT-based interventions targeting males’ physical activity and dietary practices. Objective: This study examines the effectiveness of a 9-month IT-based intervention (ManUp) to improve the physical activity, dietary behaviors, and health literacy in middle-aged males compared to a print-based intervention. Methods: Participants, recruited offline (eg, newspaper ads), were randomized into either an IT-based or print-based intervention arm on a 2:1 basis in favor of the fully automated IT-based arm. Participants were adult males aged 35-54 years living in 2 regional cities in Queensland, Australia, who could access the Internet, owned a mobile phone, and were able to increase their activity level. The intervention, ManUp, was based on social cognitive and self-regulation theories and specifically designed to target males. Educational materials were provided and self-monitoring of physical activity and nutrition behaviors was promoted. Intervention content was the same in both intervention arms; only the delivery mode differed. Content could be accessed throughout the 9-month study period. Participants’ physical activity, dietary behaviors, and health literacy were measured using online surveys at baseline, 3 months, and 9 months. Results: A total of 301 participants completed baseline assessments, 205 in the IT-based arm and 96 in the print-based arm. A total of 124 participants completed all 3 assessments. There were no significant between-group differences in physical activity and dietary behaviors (P≥.05). Participants reported an increased number of minutes and sessions of physical activity at 3 months (exp(β)=1.45, 95% CI 1.09-1.95; exp(β)=1.61, 95% CI 1.17-2.22) and 9 months (exp(β)=1.55, 95% CI 1.14-2.10; exp(β)=1.51, 95% CI 1.15-2.00). Overall dietary behaviors improved at 3 months (exp(β)=1.07, 95% CI 1.03-1.11) and 9 months (exp(β)=1.10, 95% CI 1.05-1.13). The proportion of participants in both groups eating higher-fiber bread and low-fat milk increased at 3 months (exp(β)=2.25, 95% CI 1.29-3.92; exp(β)=1.65, 95% CI 1.07-2.55). Participants in the IT-based arm were less likely to report that 30 minutes of physical activity per day improves health (exp(β)=0.48, 95% CI 0.26-0.90) and more likely to report that vigorous intensity physical activity 3 times per week is essential (exp(β)=1.70, 95% CI 1.02-2.82). The average number of log-ins to the IT platform at 3 and 9 months was 6.99 (SE 0.86) and 9.22 (SE 1.47), respectively. The average number of self-monitoring entries at 3 and 9 months was 16.69 (SE 2.38) and 22.51 (SE 3.79), respectively. Conclusions: The ManUp intervention was effective in improving physical activity and dietary behaviors in middle-aged males with no significant differences between IT- and print-based delivery modes. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12611000081910; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000081910 (Archived by WebCite at http://www.webcitation.org/6QHIWad63). %M 24927299 %R 10.2196/jmir.3107 %U http://www.jmir.org/2014/6/e136/ %U https://doi.org/10.2196/jmir.3107 %U http://www.ncbi.nlm.nih.gov/pubmed/24927299 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 6 %P e140 %T Feasibility and Effectiveness of a Web-Based Positive Psychology Program for Youth Mental Health: Randomized Controlled Trial %A Manicavasagar,Vijaya %A Horswood,Deserae %A Burckhardt,Rowan %A Lum,Alistair %A Hadzi-Pavlovic,Dusan %A Parker,Gordon %+ Black Dog Institute, School of Psychiatry, UNSW Australia, Hospital Rd, Randwick, 2031, Australia, 61 2 9382 4320, v.manicavasagar@unsw.edu.au %K adolescent %K resilience %K psychological %K mental health %K Internet %K early medical intervention %D 2014 %7 04.06.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Youth mental health is a significant public health concern due to the high prevalence of mental health problems in this population and the low rate of those affected seeking help. While it is increasingly recognized that prevention is better than cure, most youth prevention programs have utilized interventions based on clinical treatments (eg, cognitive behavioral therapy) with inconsistent results. Objective: This study explores the feasibility of the online delivery of a youth positive psychology program, Bite Back, to improve the well-being and mental health outcomes of Australian youth. Further aims were to examine rates of adherence and attrition, and to investigate the program’s acceptability. Methods: Participants (N=235) aged 12-18 years were randomly assigned to either of two conditions: Bite Back (n=120) or control websites (n=115). The Bite Back website comprised interactive exercises and information across a variety of positive psychology domains; the control condition was assigned to neutral entertainment-based websites that contained no psychology information. Participants in both groups were instructed to use their allocated website for 6 consecutive weeks. Participants were assessed pre- and postintervention on the Depression Anxiety Stress Scale-Short form (DASS-21) and the Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS). Results: Of the 235 randomized participants, 154 (65.5%) completed baseline and post measures after 6 weeks. Completers and dropouts were equivalent in demographics, the SWEMWBS, and the depression and anxiety subscales of the DASS-21, but dropouts reported significantly higher levels of stress than completers. There were no differences between the Bite Back and control conditions at baseline on demographic variables, DASS-21, or SWEMWBS scores. Qualitative data indicated that 49 of 61 Bite Back users (79%) reported positive experiences using the website and 55 (89%) agreed they would continue to use it after study completion. Compared to the control condition, participants in the Bite Back condition with high levels of adherence (usage of the website for 30 minutes or more per week) reported significant decreases in depression and stress and improvements in well-being. Bite Back users who visited the site more frequently (≥3 times per week) reported significant decreases in depression and anxiety and improvements in well-being. No significant improvements were found among Bite Back users who demonstrated low levels of adherence or who used the website less frequently. Conclusions: Results suggest that using an online positive psychology program can decrease symptoms of psychopathology and increase well-being in young people, especially for those who use the website for 30 minutes or longer per week or more frequently (≥3 times per week). Acceptability of the Bite Back website was high. These findings are encouraging and suggest that the online delivery of positive psychology programs may be an alternate way to address mental health issues and improve youth well-being nationally. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN1261200057831; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362489 (Archived by Webcite at http://www.webcitation.org/6NXmjwfAy). %M 24901900 %R 10.2196/jmir.3176 %U http://www.jmir.org/2014/6/e140/ %U https://doi.org/10.2196/jmir.3176 %U http://www.ncbi.nlm.nih.gov/pubmed/24901900 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 6 %P e142 %T The Effectiveness of Electronic Screening and Brief Intervention for Reducing Levels of Alcohol Consumption: A Systematic Review and Meta-Analysis %A Donoghue,Kim %A Patton,Robert %A Phillips,Thomas %A Deluca,Paolo %A Drummond,Colin %+ Institute of Psychiatry, Addictions Department, King's College London, Addiction Sciences Building, 4 Windsor Walk, London, SE5 8BB, United Kingdom, 44 207 848 0437, kim.donoghue@kcl.ac.uk %K alcohol drinking %K intervention studies %K Internet %K computers %K meta-analysis %D 2014 %7 02.06.2014 %9 Review %J J Med Internet Res %G English %X Background: Electronic screening and brief intervention (eSBI) has been shown to reduce alcohol consumption, but its effectiveness over time has not been subject to meta-analysis. Objective: The current study aims to conduct a systematic review and meta-analysis of the available literature to determine the effectiveness of eSBI over time in nontreatment-seeking hazardous/harmful drinkers. Methods: A systematic review and meta-analysis of relevant studies identified through searching the electronic databases PsychINFO, Medline, and EMBASE in May 2013. Two members of the study team independently screened studies for inclusion criteria and extracted data. Studies reporting data that could be transformed into grams of ethanol per week were included in the meta-analysis. The mean difference in grams of ethanol per week between eSBI and control groups was weighted using the random-effects method based on the inverse-variance approach to control for differences in sample size between studies. Results: There was a statistically significant mean difference in grams of ethanol consumed per week between those receiving an eSBI versus controls at up to 3 months (mean difference –32.74, 95% CI –56.80 to –8.68, z=2.67, P=.01), 3 to less than 6 months (mean difference –17.33, 95% CI –31.82 to –2.84, z=2.34, P=.02), and from 6 months to less than 12 months follow-up (mean difference –14.91, 95% CI –25.56 to –4.26, z=2.74, P=.01). No statistically significant difference was found at a follow-up period of 12 months or greater (mean difference –7.46, 95% CI –25.34 to 10.43, z=0.82, P=.41). Conclusions: A significant reduction in weekly alcohol consumption between intervention and control conditions was demonstrated between 3 months and less than 12 months follow-up indicating eSBI is an effective intervention. %M 24892426 %R 10.2196/jmir.3193 %U http://www.jmir.org/2014/6/e142/ %U https://doi.org/10.2196/jmir.3193 %U http://www.ncbi.nlm.nih.gov/pubmed/24892426 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 5 %P e143 %T Effectiveness of a Web-Based Tailored Intervention (E-health4Uth) and Consultation to Promote Adolescents’ Health: Randomized Controlled Trial %A Bannink,Rienke %A Broeren,Suzanne %A Joosten-van Zwanenburg,Evelien %A van As,Els %A van de Looij-Jansen,Petra %A Raat,Hein %+ Erasmus University Medical Center Rotterdam, Department of Public Health, PO Box 2040, 3000 CA, Rotterdam, , Netherlands, 31 107044634, h.raat@erasmusmc.nl %K adolescents %K youth health care %K eHealth %K Internet %K Web-based tailoring %K consultation %K randomized controlled trial %K health promotion %K prevention %D 2014 %7 30.05.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: To promote well-being and health behaviors among adolescents, 2 interventions were implemented at 12 secondary schools. Adolescents in the E-health4Uth group received Web-based tailored messages focused on their health behaviors and well-being. Adolescents in the E-health4Uth and consultation group received the same tailored messages, but were subsequently referred to a school nurse for a consultation if they were at risk of mental health problems. Objective: This study evaluated the effect of E-health4Uth and E-health4Uth and consultation on well-being (ie, mental health status and health-related quality of life) and health behaviors (ie, alcohol and drug use, smoking, safe sex). Methods: A cluster randomized controlled trial was conducted among third- and fourth-year secondary school students (mean age 15.9, SD 0.69). School classes (clusters) were randomly assigned to (1) E-health4Uth group, (2) E-health4Uth and consultation group, or (3) control group (ie, care as usual). Adolescents completed a questionnaire at baseline and at 4-month follow-up assessing alcohol consumption, smoking, drug use, condom use, mental health via the Strengths and Difficulties Questionnaire (SDQ) and the Youth Self Report (YSR; only measured at follow-up), and health-related quality of life. Multilevel logistic, ordinal, and linear regression analyses were used to reveal differences in health behavior and well-being between the intervention groups and the control group at follow-up. Subsequently, it was explored whether demographics moderated the effects. Results: Data from 1256 adolescents were analyzed. Compared to the control intervention, the E-health4Uth intervention, as a standalone intervention, showed minor positive results in health-related quality of life (B=2.79, 95% CI 0.72-4.87) and condom use during intercourse among adolescents of Dutch ethnicity (OR 3.59, 95% CI 1.71-7.55) not replicated in the E-health4Uth and consultation group. The E-health4Uth and consultation intervention showed minor positive results in the mental health status of adolescents (SDQ: B=−0.60, 95% CI −1.17 to −0.04), but a negative effect on drug use among boys (OR 0.36, 95% CI 0.13-0.96). In the subgroup of adolescents who were at risk of mental health problems at baseline (and referred for a consultation with the nurse), the E-health4Uth and consultation group showed minor to moderate positive results in mental health status (SDQ: B=−1.79, 95% CI −3.35 to −0.22; YSR: B=−9.11, 95% CI −17.52 to −0.71) and health-related quality of life (B=7.81, 95% CI 2.41-13.21) at follow-up compared to adolescents in the control group who were at risk of mental health problems at baseline. Conclusions: Findings from this study support the use of the E-health4Uth and consultation intervention in promoting the well-being of adolescents at risk of mental health problems. Future research is needed to further evaluate the effects of the consultation as a standalone intervention, and the dual approach of further tailored eHealth messages and a consultation. Trial Registration: Nederlands Trial Register: NTR 3596; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3596 (Archived by WebCite at http://www.webcitation.org/6PmgrPOuv). %M 24878521 %R 10.2196/jmir.3163 %U http://www.jmir.org/2014/5/e143/ %U https://doi.org/10.2196/jmir.3163 %U http://www.ncbi.nlm.nih.gov/pubmed/24878521 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 5 %P e141 %T Effectiveness of a Web-Based Solution-Focused Brief Chat Treatment for Depressed Adolescents and Young Adults: Randomized Controlled Trial %A Kramer,Jeannet %A Conijn,Barbara %A Oijevaar,Pien %A Riper,Heleen %+ Trimbos Institute (Netherlands Institute of Mental Health and Addiction), Post Office Box 725, Utrecht, 3500 AS, Netherlands, 31 (0)30 2959380, jkramer@trimbos.nl %K depression %K randomized controlled trial %K Internet %K Solution Focused Brief Therapy %K young adults %D 2014 %7 29.05.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Up to 9% of young people suffer from depression. Unfortunately, many in need of help remain untreated. The Internet offers anonymous ways to help depressed youth, especially those who are reluctant to search for help because of fear of stigma. Objective: Our goal was to evaluate the effectiveness of an individual chat treatment based on Solution-Focused Brief Therapy (SFBT) to young individuals aged 12-22 years with depressive symptoms by comparing it to a waiting list control group. Methods: For this study, 263 young people with depressive symptoms were randomized to the Web-based SFBT intervention, PratenOnline, or to a waiting list control condition. The chat treatment was delivered by trained professionals. Groups were compared on depressive complaints as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) after 9 weeks and 4.5 months. For the chat group only, changes in depressive symptoms at 7.5 months after baseline were explored. Results: The experimental SFBT condition (n=131) showed significantly greater improvement than the waiting list condition (n=132) in depressive symptoms at 9 weeks and 4.5 months on the CES-D, with a small between group effect size at 9 weeks (d=0.18, 95% CI -0.10 to 0.47) and a large effect size at 4.5 months (d=0.79, 95% CI 0.45-1.08). The percentage of participants showing a reliable and clinically significant change in depression was significantly larger for the SFBT intervention at 4.5 months only (28.2% vs 11.4% for the waiting list, P<.001, number needed to treat=6). At 7.5 months, the SFBT group showed further improvements. However, results have to be considered carefully because of high attrition rates. Conclusions: The Web-based SFBT chat intervention of PratenOnline was more effective than a waiting list control group in reducing depressive symptoms, and effects were larger at follow-up then at post-treatment. More studies are needed to find out if outcomes will be replicated, especially for those younger than 18 year old. Trial Registration: Netherlands Trial Register: NTR 1696; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1696 (Archived by WebCite at http://www.webcitation.org/6DspeYWrJ). %M 24874006 %R 10.2196/jmir.3261 %U http://www.jmir.org/2014/5/e141/ %U https://doi.org/10.2196/jmir.3261 %U http://www.ncbi.nlm.nih.gov/pubmed/24874006 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 2 %N 2 %P e25 %T A Persuasive and Social mHealth Application for Physical Activity: A Usability and Feasibility Study %A Al Ayubi,Soleh U %A Parmanto,Bambang %A Branch,Robert %A Ding,Dan %+ Health and Rehabilitation Informatics Laboratory, Department of Health Information Management, University of Pittsburgh, 6026 Forbes Tower, Pittsburgh, PA, , United States, 1 412 383 6649, parmanto@pitt.edu %K mobile applications %K mHealth %K self-management %K social support %K persuasion %K physical activity %K usability %K feasibility studies %K pedometer %D 2014 %7 22.05.2014 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: Advances in smartphones and the wide usage of social networking systems offer opportunities for the development of innovative interventions to promote physical activity. To that end, we developed a persuasive and social mHealth application designed to monitor and motivate users to walk more every day. Objective: The objectives of this project were to conduct a focused review on the fundamental characteristics of mHealth for physical activity promotion, to develop an mHealth application that meets such characteristics, and to conduct a feasibility study to deploy the application in everyday life. Methods: This project started as an analytical study to review the fundamental characteristics of the technologies used in physical activity monitoring and promotion. Then, it was followed by a technical development of the application. Next, a 4 week deployment was conducted where participants used the application as part of their daily life. A think-aloud method and in-depth semistructured interviews were conducted following the deployment. A qualitative description method was used to thematically analyze the interviews. Feasibility measures included, adherence to the program, user-system interactions, motivation to use, and experience with physical activity and online social interactions. Results: There were seven fundamental characteristics of physical activity monitoring and promotion that were identified, which were then used as a foundation to develop the application. There were fourteen participants that enrolled in the application evaluation. The age range was from 24 to 45; body mass index ranged from 18.5 to 42.98, with 4 of the subjects falling into the category “obese”. Half of them were experienced with smartphones, and all were familiar with a social network system. There were thirteen participants that completed the study; one was excluded. Overall, participants gave high scores to almost all of the usability factors examined, with averages of 4.52 out of a 5.00 maximum. Over 29 days, participants used the application for a total of 119,380 minutes (average=7.57 hours/day/participant; SD 1.56). Conclusions: Based on the fundamental characteristics, the application was successfully developed. The usability results suggest that the system is usable and user satisfaction was high. Deploying the application was shown to be feasible for the promotion of daily physical activity. %M 25099928 %R 10.2196/mhealth.2902 %U http://mhealth.jmir.org/2014/2/e25/ %U https://doi.org/10.2196/mhealth.2902 %U http://www.ncbi.nlm.nih.gov/pubmed/25099928 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 5 %P e130 %T Computer-Delivered and Web-Based Interventions to Improve Depression, Anxiety, and Psychological Well-Being of University Students: A Systematic Review and Meta-Analysis %A Davies,E Bethan %A Morriss,Richard %A Glazebrook,Cris %+ Division of Psychiatry and Applied Psychology, School of Medicine, Institute of Mental Health, The University of Nottingham, Jubilee Campus, Triumph Road, Nottingham, NG7 2TU, United Kingdom, 44 0115 74 84293, mcxebd@nottingham.ac.uk %K systematic review %K meta-analysis %K intervention %K universities %K students %K mental health %K depression %K anxiety %K health promotion %D 2014 %7 16.05.2014 %9 Review %J J Med Internet Res %G English %X Background: Depression and anxiety are common mental health difficulties experienced by university students and can impair academic and social functioning. Students are limited in seeking help from professionals. As university students are highly connected to digital technologies, Web-based and computer-delivered interventions could be used to improve students’ mental health. The effectiveness of these intervention types requires investigation to identify whether these are viable prevention strategies for university students. Objective: The intent of the study was to systematically review and analyze trials of Web-based and computer-delivered interventions to improve depression, anxiety, psychological distress, and stress in university students. Methods: Several databases were searched using keywords relating to higher education students, mental health, and eHealth interventions. The eligibility criteria for studies included in the review were: (1) the study aimed to improve symptoms relating to depression, anxiety, psychological distress, and stress, (2) the study involved computer-delivered or Web-based interventions accessed via computer, laptop, or tablet, (3) the study was a randomized controlled trial, and (4) the study was trialed on higher education students. Trials were reviewed and outcome data analyzed through random effects meta-analyses for each outcome and each type of trial arm comparison. Cochrane Collaboration risk of bias tool was used to assess study quality. Results: A total of 17 trials were identified, in which seven were the same three interventions on separate samples; 14 reported sufficient information for meta-analysis. The majority (n=13) were website-delivered and nine interventions were based on cognitive behavioral therapy (CBT). A total of 1795 participants were randomized and 1480 analyzed. Risk of bias was considered moderate, as many publications did not sufficiently report their methods and seven explicitly conducted completers’ analyses. In comparison to the inactive control, sensitivity meta-analyses supported intervention in improving anxiety (pooled standardized mean difference [SMD] −0.56; 95% CI −0.77 to −0.35, P<.001), depression (pooled SMD −0.43; 95% CI −0.63 to −0.22, P<.001), and stress (pooled SMD −0.73; 95% CI −1.27 to −0.19, P=.008). In comparison to active controls, sensitivity analyses did not support either condition for anxiety (pooled SMD −0.18; 95% CI −0.98 to 0.62, P=.66) or depression (pooled SMD −0.28; 95% CI −0.75 to −0.20, P=.25). In contrast to a comparison intervention, neither condition was supported in sensitivity analyses for anxiety (pooled SMD −0.10; 95% CI −0.39 to 0.18, P=.48) or depression (pooled SMD −0.33; 95% CI −0.43 to 1.09, P=.40). Conclusions: The findings suggest Web-based and computer-delivered interventions can be effective in improving students’ depression, anxiety, and stress outcomes when compared to inactive controls, but some caution is needed when compared to other trial arms and methodological issues were noticeable. Interventions need to be trialed on more heterogeneous student samples and would benefit from user evaluation. Future trials should address methodological considerations to improve reporting of trial quality and address post-intervention skewed data. %M 24836465 %R 10.2196/jmir.3142 %U http://www.jmir.org/2014/5/e130/ %U https://doi.org/10.2196/jmir.3142 %U http://www.ncbi.nlm.nih.gov/pubmed/24836465 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 5 %P e121 %T Short-Term Effects of a Web-Based Guided Self-Help Intervention for Employees With Depressive Symptoms: Randomized Controlled Trial %A Geraedts,Anna S %A Kleiboer,Annet M %A Wiezer,Noortje M %A van Mechelen,Willem %A Cuijpers,Pim %+ VU University Amsterdam, Department of Clinical Psychology, Van der Boechorststraat 1, Amsterdam, 1081 BT, Netherlands, 31 205987451, a.s.geraedts@vu.nl %K depression, employees, occupational therapy, Internet, prevention %D 2014 %7 06.05.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Depressive disorders are highly prevalent in the working population and are associated with excessive costs. The evidence for effective worker-directed interventions for employees with depressive symptoms is limited. Treating employees with depressive symptoms before sick leave via the Internet could be beneficial and cost saving. Objective: In this study, we developed and tested the effectiveness of a Web-based guided self-help course for employees with depressive symptoms. We report on the posttreatment effectiveness of the intervention. Methods: This study is a two-arm randomized controlled trial comparing a Web-based guided self-help course to care as usual (CAU). We recruited employees from 6 different companies via the companies’ intranet and posters. The main inclusion criterion was elevated depressive symptoms as measured by a score of ≥16 on the Center for Epidemiological Studies Depression scale (CES-D). The intervention (Happy@Work) was based on problem-solving treatment and cognitive therapy and consisted of 6 weekly lessons. Participants were asked to submit their weekly assignment via the website after completion. They subsequently received feedback from a coach via the website. Self-report questionnaires on depressive symptoms (CES-D; primary outcome), anxiety measured by the Hospital Anxiety and Depression Scale (HADS), burnout measured by the Maslach Burnout Inventory (MBI), and work performance measured by the Health and Work Performance Questionnaire (HPQ; secondary outcomes) were completed at baseline and at posttreatment. Results: A total of 231 employees were randomized to either the intervention group (n=116) or CAU (n=115).The posttreatment assessment was completed by 171 (74.0%) participants. Both the intervention and the CAU group showed significant improvements in the primary outcome of depressive symptoms, but no differences between the conditions was found (d=0.16, 95% CI –0.10 to 0.41, P=.29). Significant but small effects in favor of the intervention group were found for anxiety symptoms (d=0.16, 95% CI –0.09 to 0.42, P=.04) and exhaustion (d=0.17, 95% CI –0.09 to 0.43, P=.02). Conclusions: This study showed that a Web-based guided self-help course for employees with depressive symptoms was not more effective in reducing depressive symptoms among employees than CAU. Large improvements in depressive symptoms in the CAU group were unforeseen and potential explanations are discussed. %M 24800966 %R 10.2196/jmir.3185 %U http://www.jmir.org/2014/5/e121/ %U https://doi.org/10.2196/jmir.3185 %U http://www.ncbi.nlm.nih.gov/pubmed/24800966 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 4 %P e114 %T Adherence to Self-Monitoring via Interactive Voice Response Technology in an eHealth Intervention Targeting Weight Gain Prevention Among Black Women: Randomized Controlled Trial %A Steinberg,Dori M %A Levine,Erica L %A Lane,Ilana %A Askew,Sandy %A Foley,Perry B %A Puleo,Elaine %A Bennett,Gary G %+ Duke Obesity Prevention Program, Duke Global Health Institute, Duke University, Room #134 Trent Hall, 310 Trent Drive, Durham, NC, 27708, United States, 1 919 613 5453, dori.steinberg@duke.edu %K eHealth %K obesity %K interactive voice response %K self-monitoring %D 2014 %7 29.04.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: eHealth interventions are effective for weight control and have the potential for broad reach. Little is known about the use of interactive voice response (IVR) technology for self-monitoring in weight control interventions, particularly among populations disproportionately affected by obesity. Objective: This analysis sought to examine patterns and predictors of IVR self-monitoring adherence and the association between adherence and weight change among low-income black women enrolled in a weight gain prevention intervention. Methods: The Shape Program was a randomized controlled trial comparing a 12-month eHealth behavioral weight gain prevention intervention to usual care among overweight and obese black women in the primary care setting. Intervention participants (n=91) used IVR technology to self-monitor behavior change goals (eg, no sugary drinks, 10,000 steps per day) via weekly IVR calls. Weight data were collected in clinic at baseline, 6, and 12 months. Self-monitoring data was stored in a study database and adherence was operationalized as the percent of weeks with a successful IVR call. Results: Over 12 months, the average IVR completion rate was 71.6% (SD 28.1) and 52% (47/91) had an IVR completion rate ≥80%. At 12 months, IVR call completion was significantly correlated with weight loss (r =−.22; P=.04) and participants with an IVR completion rate ≥80% had significantly greater weight loss compared to those with an IVR completion rate <80% (−1.97 kg, SE 0.67 vs 0.48 kg, SE 0.69; P=.01). Similar outcomes were found for change in body mass index (BMI; mean difference −0.94 kg, 95% CI −1.64 to −0.24; P=.009). Older, more educated participants were more likely to achieve high IVR call completion. Participants reported positive attitudes toward IVR self-monitoring. Conclusions: Adherence to IVR self-monitoring was high among socioeconomically disadvantaged black women enrolled in a weight gain prevention intervention. Higher adherence to IVR self-monitoring was also associated with greater weight change. IVR is an effective and useful tool to promote self-monitoring and has the potential for widespread use and long-term sustainability. Trial Registration: Clinicaltrials.gov NCT00938535; http://www.clinicaltrials.gov/ct2/show/NCT00938535 (Archived by WebCite at http://www.webcitation.org/6P1FFNJRs). %M 24780934 %R 10.2196/jmir.2996 %U http://www.jmir.org/2014/4/e114/ %U https://doi.org/10.2196/jmir.2996 %U http://www.ncbi.nlm.nih.gov/pubmed/24780934 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 4 %P e111 %T Usage and Effectiveness of a Fully Automated, Open-Access, Spanish Web-Based Smoking Cessation Program: Randomized Controlled Trial %A Mañanes,Guillermo %A Vallejo,Miguel A %+ Faculty of Psychology, Department of Clinical Psychology, National Distance Education University (UNED), Juan del Rosal 10, Madrid, 28040, Spain, 34 913987936, mvallejo@psi.uned.es %K smoking cessation %K Internet %K intervention studies %D 2014 %7 23.04.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: The Internet is an optimal setting to provide massive access to tobacco treatments. To evaluate open-access Web-based smoking cessation programs in a real-world setting, adherence and retention data should be taken into account as much as abstinence rate. Objective: The objective was to analyze the usage and effectiveness of a fully automated, open-access, Web-based smoking cessation program by comparing interactive versus noninteractive versions. Methods: Participants were randomly assigned either to the interactive or noninteractive version of the program, both with identical content divided into 4 interdependent modules. At baseline, we collected demographic, psychological, and smoking characteristics of the smokers self-enrolled in the Web-based program of Universidad Nacional de Educación a Distancia (National Distance Education University; UNED) in Madrid, Spain. The following questionnaires were administered: the anxiety and depression subscales from the Symptom Checklist-90-Revised, the 4-item Perceived Stress Scale, and the Heaviness of Smoking Index. At 3 months, we analyzed dropout rates, module completion, user satisfaction, follow-up response rate, and self-assessed smoking abstinence. Results: A total of 23,213 smokers were registered, 50.06% (11,620/23,213) women and 49.94% (11,593/23,213) men, with a mean age of 39.5 years (SD 10.3). Of these, 46.10% (10,701/23,213) were married and 34.43% (7992/23,213) were single, 46.03% (10,686/23,213) had university education, and 78.73% (18,275/23,213) were employed. Participants smoked an average of 19.4 cigarettes per day (SD 10.3). Of the 11,861 smokers randomly assigned to the interactive version, 2720 (22.93%) completed the first module, 1052 (8.87%) the second, 624 (5.26%) the third, and 355 (2.99%) the fourth. Completion data was not available for the noninteractive version (no way to record it automatically). The 3-month follow-up questionnaire was completed by 1085 of 23,213 enrolled smokers (4.67%). Among them, 406 (37.42%) self-reported not smoking. No difference between groups was found. Assuming missing respondents continued to smoke, the abstinence rate was 1.74% (406/23,213), in which 22,678 were missing respondents. Among follow-up respondents, completing the 4 modules of the intervention increased the chances of smoking cessation (OR 1.95, 95% CI 1.27-2.97, P<.001), as did smoking 30 minutes (OR 1.58, 95% CI 1.04-2.39, P=.003) or 1 hour after waking (OR 1.93, 95% CI 1.27-2.93, P<.001) compared to smoking within the first 5 minutes after waking. Conclusions: The findings suggest that the UNED Web-based smoking cessation program was very accessible, but a high level of attrition was confirmed. This could be related to the ease of enrollment, its free character, and the absence of direct contact with professionals. It is concluded that, in practice, the greater the accessibility to the program, the lower the adherence and retention. Professional support from health services and the payment of a reimbursable fee could prevent high rates of attrition. %M 24760951 %R 10.2196/jmir.3091 %U http://www.jmir.org/2014/4/e111/ %U https://doi.org/10.2196/jmir.3091 %U http://www.ncbi.nlm.nih.gov/pubmed/24760951 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 4 %P e106 %T Can an Internet-Based Health Risk Assessment Highlight Problems of Heart Disease Risk Factor Awareness? A Cross-Sectional Analysis %A Dickerson,Justin B %A McNeal,Catherine J %A Tsai,Ginger %A Rivera,Cathleen M %A Smith,Matthew Lee %A Ohsfeldt,Robert L %A Ory,Marcia G %+ School of Public Health, Department of Health Promotion and Community Health Sciences, Texas A&M Health Science Center, 1266 TAMU, College Station, TX, 77843, United States, 1 979 777 8714, hsrhealthservices@gmail.com %K health risk assessment %K Internet %K risk factors %K health disease %K concordance %D 2014 %7 18.04.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Health risk assessments are becoming more popular as a tool to conveniently and effectively reach community-dwelling adults who may be at risk for serious chronic conditions such as coronary heart disease (CHD). The use of such instruments to improve adults’ risk factor awareness and concordance with clinically measured risk factor values could be an opportunity to advance public health knowledge and build effective interventions. Objective: The objective of this study was to determine if an Internet-based health risk assessment can highlight important aspects of agreement between respondents’ self-reported and clinically measured CHD risk factors for community-dwelling adults who may be at risk for CHD. Methods: Data from an Internet-based cardiovascular health risk assessment (Heart Aware) administered to community-dwelling adults at 127 clinical sites were analyzed. Respondents were recruited through individual hospital marketing campaigns, such as media advertising and print media, found throughout inpatient and outpatient facilities. CHD risk factors from the Framingham Heart Study were examined. Weighted kappa statistics were calculated to measure interrater agreement between respondents’ self-reported and clinically measured CHD risk factors. Weighted kappa statistics were then calculated for each sample by strata of overall 10-year CHD risk. Three samples were drawn based on strategies for treating missing data: a listwise deleted sample, a pairwise deleted sample, and a multiple imputation (MI) sample. Results: The MI sample (n=16,879) was most appropriate for addressing missing data. No CHD risk factor had better than marginal interrater agreement (κ>.60). High-density lipoprotein cholesterol (HDL-C) exhibited suboptimal interrater agreement that deteriorated (eg, κ<.30) as overall CHD risk increased. Conversely, low-density lipoprotein cholesterol (LDL-C) interrater agreement improved (eg, up to κ=.25) as overall CHD risk increased. Overall CHD risk of the sample was lower than comparative population-based CHD risk (ie, no more than 15% risk of CHD for the sample vs up to a 30% chance of CHD for the population). Conclusions: Interventions are needed to improve knowledge of CHD risk factors. Specific interventions should address perceptions of HDL-C and LCL-C. Internet-based health risk assessments such as Heart Aware may contribute to public health surveillance, but they must address selection bias of Internet-based recruitment methods. %M 24760950 %R 10.2196/jmir.2369 %U http://www.jmir.org/2014/4/e106/ %U https://doi.org/10.2196/jmir.2369 %U http://www.ncbi.nlm.nih.gov/pubmed/24760950 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 4 %P e109 %T Factors Related to Sustained Use of a Free Mobile App for Dietary Self-Monitoring With Photography and Peer Feedback: Retrospective Cohort Study %A Helander,Elina %A Kaipainen,Kirsikka %A Korhonen,Ilkka %A Wansink,Brian %+ Department of Signal Processing, Tampere University of Technology, Korkeakoulunkatu 1, Tampere, , Finland, 358 4317579, elina.helander@tut.fi %K healthy eating %K food journaling %K food photographing %K adherence %K mobile app %K self-monitoring %K peer feedback %K control theory %D 2014 %7 15.04.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Healthy eating interventions that use behavior change techniques such as self-monitoring and feedback have been associated with stronger effects. Mobile apps can make dietary self-monitoring easy with photography and potentially reach huge populations. Objective: The aim of the study was to assess the factors related to sustained use of a free mobile app (“The Eatery”) that promotes healthy eating through photographic dietary self-monitoring and peer feedback. Methods: A retrospective analysis was conducted on the sample of 189,770 people who had downloaded the app and used it at least once between October 2011 and April 2012. Adherence was defined based on frequency and duration of self-monitoring. People who had taken more than one picture were classified as “Users” and people with one or no pictures as “Dropouts”. Users who had taken at least 10 pictures and used the app for at least one week were classified as “Actives”, Users with 2-9 pictures as “Semi-actives”, and Dropouts with one picture as “Non-actives”. The associations between adherence, registration time, dietary preferences, and peer feedback were examined. Changes in healthiness ratings over time were analyzed among Actives. Results: Overall adherence was low—only 2.58% (4895/189,770) used the app actively. The day of week and time of day the app was initially used was associated with adherence, where 20.28% (5237/25,820) of Users had started using the app during the daytime on weekdays, in comparison to 15.34% (24,718/161,113) of Dropouts. Users with strict diets were more likely to be Active (14.31%, 900/6291) than those who had not defined any diet (3.99%, 742/18,590), said they ate everything (9.47%, 3040/32,090), or reported some other diet (11.85%, 213/1798) (χ23=826.6, P<.001). The average healthiness rating from peers for the first picture was higher for Active users (0.55) than for Semi-actives (0.52) or Non-actives (0.49) (F2,58167=225.9, P<.001). Actives wrote more often a textual description for the first picture than Semi-actives or Non-actives (χ22=3515.1, P<.001). Feedback beyond ratings was relatively infrequent: 3.83% (15,247/398,228) of pictures received comments and 15.39% (61,299/398,228) received “likes” from other users. Actives were more likely to have at least one comment or one “like” for their pictures than Semi-actives or Non-actives (χ22=343.6, P<.001, and χ22=909.6, P<.001, respectively). Only 9.89% (481/4863) of Active users had a positive trend in their average healthiness ratings. Conclusions: Most people who tried out this free mobile app for dietary self-monitoring did not continue using it actively and those who did may already have been healthy eaters. Hence, the societal impact of such apps may remain small if they fail to reach those who would be most in need of dietary changes. Incorporating additional self-regulation techniques such as goal-setting and intention formation into the app could potentially increase user engagement and promote sustained use. %M 24735567 %R 10.2196/jmir.3084 %U http://www.jmir.org/2014/4/e109/ %U https://doi.org/10.2196/jmir.3084 %U http://www.ncbi.nlm.nih.gov/pubmed/24735567 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 4 %P e104 %T Mobile Applications for Diabetics: A Systematic Review and Expert-Based Usability Evaluation Considering the Special Requirements of Diabetes Patients Age 50 Years or Older %A Arnhold,Madlen %A Quade,Mandy %A Kirch,Wilhelm %+ Research Association Public Health Saxony and Saxony-Anhalt, Medizinische Fakultät Carl Gustav Carus, Technische Universität Dresden, Fiedlerstraße 33, Dresden, 01307, Germany, 49 351 458 13457, Madlen.Arnhold@tu-dresden.de %K mobile applications %K apps %K mobile health %K mHealth %K diabetes mellitus %K market analysis %K systematic review %K elderly %K usability test %K expert review %D 2014 %7 09.04.2014 %9 Review %J J Med Internet Res %G English %X Background: A multitude of mhealth (mobile health) apps have been developed in recent years to support effective self-management of patients with diabetes mellitus type 1 or 2. Objective: We carried out a systematic review of all currently available diabetes apps for the operating systems iOS and Android. We considered the number of newly released diabetes apps, range of functions, target user groups, languages, acquisition costs, user ratings, available interfaces, and the connection between acquisition costs and user ratings. Additionally, we examined whether the available applications serve the special needs of diabetes patients aged 50 or older by performing an expert-based usability evaluation. Methods: We identified relevant keywords, comparative categories, and their specifications. Subsequently, we performed the app review based on the information given in the Google Play Store, the Apple App Store, and the apps themselves. In addition, we carried out an expert-based usability evaluation based on a representative 10% sample of diabetes apps. Results: In total, we analyzed 656 apps finding that 355 (54.1%) offered just one function and 348 (53.0%) provided a documentation function. The dominating app language was English (85.4%, 560/656), patients represented the main user group (96.0%, 630/656), and the analysis of the costs revealed a trend toward free apps (53.7%, 352/656). The median price of paid apps was €1.90. The average user rating was 3.6 stars (maximum 5). Our analyses indicated no clear differences in the user rating between free and paid apps. Only 30 (4.6%) of the 656 available diabetes apps offered an interface to a measurement device. We evaluated 66 apps within the usability evaluation. On average, apps were rated best regarding the criterion “comprehensibility” (4.0 out of 5.0), while showing a lack of “fault tolerance” (2.8 out of 5.0). Of the 66 apps, 48 (72.7%) offered the ability to read the screen content aloud. The number of functions was significantly negative correlated with usability. The presence of documentation and analysis functions reduced the usability score significantly by 0.36 and 0.21 points. Conclusions: A vast number of diabetes apps already exist, but the majority offer similar functionalities and combine only one to two functions in one app. Patients and physicians alike should be involved in the app development process to a greater extent. We expect that the data transmission of health parameters to physicians will gain more importance in future applications. The usability of diabetes apps for patients aged 50 or older was moderate to good. But this result applied mainly to apps offering a small range of functions. Multifunctional apps performed considerably worse in terms of usability. Moreover, the presence of a documentation or analysis function resulted in significantly lower usability scores. The operability of accessibility features for diabetes apps was quite limited, except for the feature “screen reader”. %M 24718852 %R 10.2196/jmir.2968 %U http://www.jmir.org/2014/4/e104/ %U https://doi.org/10.2196/jmir.2968 %U http://www.ncbi.nlm.nih.gov/pubmed/24718852 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 4 %P e103 %T Adolescents Just Do Not Know What They Want: A Qualitative Study to Describe Obese Adolescents’ Experiences of Text Messaging to Support Behavior Change Maintenance Post Intervention %A Smith,Kyla L %A Kerr,Deborah A %A Fenner,Ashley A %A Straker,Leon M %+ School of Physiotherapy and Exercise Science, Faculty of Health Sciences, Curtin University, Building 408, GPO Box U1987, Perth, 6845, Australia, 61 8 9266 3694, kyla.smith@curtin.edu.au %K telemedicine %K text messaging %K adolescent %K obesity %D 2014 %7 08.04.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Adolescents are considered a hard to reach group and novel approaches are needed to encourage good health. Text messaging interventions have been reported as acceptable to adolescents but there is little evidence regarding the use of text messages with overweight and obese adolescents to support engagement or behavior change after the conclusion of a healthy lifestyle program. Objective: The intent of this study was to explore the opinions of overweight adolescents and their parents regarding the use of text messages as a support during the maintenance period following an intervention. Methods: This paper reports on the findings from focus groups conducted with adolescents (n=12) and parents (n=13) who had completed an eight-week intensive intervention known as Curtin University’s Activity, Food and Attitudes Program (CAFAP). Focus groups were conducted three months post intensive intervention. Participants were asked about their experiences of the prior three-month maintenance phase during which adolescents had received tri-weekly text messages based on the self-determination theory and goal-setting theory. Participants were asked about the style and content of text messages used as well as how they used the text messages. Data were analyzed using content and thematic analyses. Results: Two clear themes emerged from the focus groups relating to (1) what adolescents liked or thought they wanted in a text message to support behavior change, and (2) how they experienced or responded to text messages. Within the “like/want” theme, there were five sub-themes relating to the overall tone of the text, frequency, timing, reference to long-term goals, and inclusion of practical tips. Within the “response to text” theme, there were four sub-themes describing a lack of motivation, barriers to change, feelings of shame, and perceived unfavorable comparison with other adolescents. What adolescents said they wanted in text messages often conflicted with their actual experiences. Parent reports provided a useful secondary view of adolescent experience. Conclusions: The conflicting views described in this study suggest that overweight and obese adolescents may not know or have the ability to articulate how they would best be supported with text messages during a healthy lifestyle maintenance phase. Further, supporting both engagement and behavior change simultaneously with text messaging may not be possible. Intervention texts should be personalized as much as possible and minimize feelings of guilt and shame in overweight and obese adolescents. Future research with text messaging for overweight and obese adolescents should incorporate clear intervention aims and evaluation methods specifically related to adolescent engagement or behavior change. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12611001187932; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611001187932 (Archived by WebCite at http://www.webcitation.org/6LGSbk8d9). %M 24713407 %R 10.2196/jmir.3113 %U http://www.jmir.org/2014/4/e103/ %U https://doi.org/10.2196/jmir.3113 %U http://www.ncbi.nlm.nih.gov/pubmed/24713407 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 4 %P e98 %T A Smart Web Aid for Preventing Diabetes in Rural China: Preliminary Findings and Lessons %A Chen,Penglai %A Chai,Jing %A Cheng,Jing %A Li,Kaichun %A Xie,Shaoyu %A Liang,Han %A Shen,Xingrong %A Feng,Rui %A Wang,Debin %+ School of Health Services Management, Anhui Medical University, 81 Meishan Road, Hefei, 230032, China, 86 55165116395, dbwang@vip.sina.com %K diabetes mellitus %K prediabetic state %K Internet %K prevention %K evaluation %K eHealth %D 2014 %7 01.04.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Increasing cases of diabetes, a general lack of routinely operational prevention, and a long history of separating disease prevention and treatment call for immediate engagement of frontier clinicians. This applies especially to village doctors who work in rural China where the majority of the nation’s vast population lives. Objective: This study aims to develop and test an online Smart Web Aid for Preventing Type 2 Diabetes (SWAP-DM2) capable of addressing major barriers to applying proven interventions and integrating diabetes prevention into routine medical care. Methods: Development of SWAP-DM2 used evolutionary prototyping. The design of the initial system was followed by refinement cycles featuring dynamic interaction between development of practical and effective standardized operation procedures (SOPs) for diabetes prevention and Web-based assistance for implementing the SOPs. The resulting SOPs incorporated proven diabetes prevention practices in a synergetic way. SWAP-DM2 provided support to village doctors ranging from simple educational webpages and record maintenance to relatively sophisticated risk scoring and personalized counseling. Evaluation of SWAP-DM2 used data collected at baseline and 6-month follow-up assessment: (1) audio recordings of service encounters; (2) structured exit surveys of patients’ knowledge, self-efficacy, and satisfaction; (3) measurement of fasting glucose, body mass index, and blood pressure; and (4) qualitative interviews with doctors and patients. Data analysis included (1) descriptive statistics of patients who received SWAP-DM2–assisted prevention and those newly diagnosed with prediabetes and diabetes; (2) comparison of the variables assessed between baseline and follow-up assessment; and (3) narratives of qualitative data. Results: The 17 participating village doctors identified 2219 patients with elevated diabetes risk. Of these, 84.85% (1885/2219) consented to a fasting glucose test with 1022 new prediabetes and 113 new diabetes diagnoses made within 6 months. The prediabetic patients showed substantial improvement from baseline to 6-month follow-up in vegetable intake (17.0%, 43/253 vs 88.7%, 205/231), calorie intake (1.6%, 4/253 vs 71.4%, 165/231), leisure-time exercises (6.3%, 16/253 vs 21.2%, 49/231), body weight (mean 62.12 kg, SD 9.85 vs mean 58.33 kg, SD 9.18), and body mass index (mean 24.80 kg/m2, SD 3.21 vs mean 23.36 kg/m2, SD 2.95). The prediabetic patients showed improvement in self-efficacy for modifying diet (mean 5.31, SD 2.81 vs mean 8.53, SD 2.25), increasing physical activities (mean 4.52, SD 3.35 vs mean 8.06, SD 2.38), engaging relatives (mean 3.93, SD 3.54 vs mean 6.93, SD 2.67), and knowledge about diabetes and risks of an imbalanced diet and inadequate physical activity. Most participating doctors and patients viewed SWAP-DM2 as useful and effective. Conclusions: SWAP-DM2 is helpful to village doctors, acceptable to patients, and effective in modifying immediate determinants of diabetes at least in the short term, and may provide a useful solution to the general lack of participation in diabetes prevention by frontier clinicians in rural China. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 66772711; http://www.controlled-trials.com/ISRCTN66772711 (Archived by WebCite at http://www.webcitation.org/6OMkAqyEy). %M 24691410 %R 10.2196/jmir.3228 %U http://www.jmir.org/2014/4/e98/ %U https://doi.org/10.2196/jmir.3228 %U http://www.ncbi.nlm.nih.gov/pubmed/24691410 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 3 %P e92 %T Internet-Based Motivation Program for Women With Eating Disorders: Eating Disorder Pathology and Depressive Mood Predict Dropout %A von Brachel,Ruth %A Hötzel,Katrin %A Hirschfeld,Gerrit %A Rieger,Elizabeth %A Schmidt,Ulrike %A Kosfelder,Joachim %A Hechler,Tanja %A Schulte,Dietmar %A Vocks,Silja %+ Department of Clinical Psychology and Psychotherapy, Osnabrück University, Knollstr 15, Osnabrück, 49069, Germany, 49 541 969 ext 4743, ruth.vonbrachel@rub.de %K attrition %K Web-based treatment %K eHealth, eating disorders %K motivation to change %K anorexia nervosa %K bulimia nervosa %K bootstrapping %K survival analysis %D 2014 %7 31.03.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: One of the main problems of Internet-delivered interventions for a range of disorders is the high dropout rate, yet little is known about the factors associated with this. We recently developed and tested a Web-based 6-session program to enhance motivation to change for women with anorexia nervosa, bulimia nervosa, or related subthreshold eating pathology. Objective: The aim of the present study was to identify predictors of dropout from this Web program. Methods: A total of 179 women took part in the study. We used survival analyses (Cox regression) to investigate the predictive effect of eating disorder pathology (assessed by the Eating Disorders Examination-Questionnaire; EDE-Q), depressive mood (Hopkins Symptom Checklist), motivation to change (University of Rhode Island Change Assessment Scale; URICA), and participants’ age at dropout. To identify predictors, we used the least absolute shrinkage and selection operator (LASSO) method. Results: The dropout rate was 50.8% (91/179) and was equally distributed across the 6 treatment sessions. The LASSO analysis revealed that higher scores on the Shape Concerns subscale of the EDE-Q, a higher frequency of binge eating episodes and vomiting, as well as higher depression scores significantly increased the probability of dropout. However, we did not find any effect of the URICA or age on dropout. Conclusions: Women with more severe eating disorder pathology and depressive mood had a higher likelihood of dropping out from a Web-based motivational enhancement program. Interventions such as ours need to address the specific needs of women with more severe eating disorder pathology and depressive mood and offer them additional support to prevent them from prematurely discontinuing treatment. %M 24686856 %R 10.2196/jmir.3104 %U http://www.jmir.org/2014/3/e92/ %U https://doi.org/10.2196/jmir.3104 %U http://www.ncbi.nlm.nih.gov/pubmed/24686856 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 3 %P e95 %T Does Brief Telephone Support Improve Engagement With a Web-Based Weight Management Intervention? Randomized Controlled Trial %A Dennison,Laura %A Morrison,Leanne %A Lloyd,Scott %A Phillips,Dawn %A Stuart,Beth %A Williams,Sarah %A Bradbury,Katherine %A Roderick,Paul %A Murray,Elizabeth %A Michie,Susan %A Little,Paul %A Yardley,Lucy %+ University of Southampton, Academic Unit of Psychology, Highfield Campus, Highfield, Southampton, SO17 1BJ, United Kingdom, 44 02380 597657, l.k.dennison@soton.ac.uk %K weight loss %K obesity %K Internet %K adherence %K behavioral %K randomized controlled trial %D 2014 %7 28.03.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Recent reviews suggest Web-based interventions are promising approaches for weight management but they identify difficulties with suboptimal usage. The literature suggests that offering some degree of human support to website users may boost usage and outcomes. Objective: We disseminated the POWeR (“Positive Online Weight Reduction”) Web-based weight management intervention in a community setting. POWeR consisted of weekly online sessions that emphasized self-monitoring, goal-setting, and cognitive/behavioral strategies. Our primary outcome was intervention usage and we investigated whether this was enhanced by the addition of brief telephone coaching. We also explored group differences in short-term self-reported weight loss. Methods: Participants were recruited using a range of methods including targeted mailouts, advertisements in the local press, notices on organizational websites, and social media. A total of 786 adults were randomized at an individual level through an online procedure to (1) POWeR only (n=264), (2) POWeR plus coaching (n=247), or (3) a waiting list control group (n=275). Those in the POWeR plus coaching arm were contacted at approximately 7 and 28 days after randomization for short coaching telephone calls aimed at promoting continued usage of the website. Website usage was tracked automatically. Weight was assessed by online self-report. Results: Of the 511 participants allocated to the two intervention groups, the median number of POWeR sessions completed was just one (IQR 0-2 for POWeR only, IQR 0-3 for POWeR plus coach). Nonetheless, a substantial minority completed at least the core three sessions of POWeR: 47 participants (17.8%, 47/264) in the POWeR-only arm and 64 participants (25.9%, 64/247) in the POWeR plus coaching arm. Participants in the POWeR plus coaching group persisted with the intervention for longer and were 1.61 times more likely to complete the core three sessions than the POWeR-only group (χ21=4.93; OR 1.61, 95% CI 1.06-2.47; n=511). An intention-to-treat analysis showed between-group differences in weight loss (F2,782=12.421, P<.001). Both intervention groups reported more weight loss than the waiting list control group. Weight loss was slightly, but not significantly, greater in the POWeR plus coaching group. A large proportion of participants assigned to POWeR plus coaching refused phone calls or were not contactable (57.9%, 143/247). Exploratory analyses identified health and sociodemographic differences between those who did and did not engage in coaching when it was made available to them. Users who engaged with coaching used the intervention more and lost more weight than those who did not. Conclusions: In common with most Web-based intervention studies, usage of POWeR was suboptimal overall. However, our findings suggest that supplementing Web-based weight management with brief human support could improve usage and outcomes in those who take it up. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 98176068; http://www.controlled-trials.com/ISRCTN98176068 (Archived by WebCite at http://www.webcitation.org/6OKRjM2oy). %M 24681761 %R 10.2196/jmir.3199 %U http://www.jmir.org/2014/3/e95/ %U https://doi.org/10.2196/jmir.3199 %U http://www.ncbi.nlm.nih.gov/pubmed/24681761 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 3 %P e90 %T Acceptability of Online Self-Help to People With Depression: Users’ Views of MoodGYM Versus Informational Websites %A Schneider,Justine %A Sarrami Foroushani,Pooria %A Grime,Paul %A Thornicroft,Graham %+ Institute of Mental Health & School of Sociology & Social Policy, University of Nottingham, University Park, Nottingham, NG7 2RD, United Kingdom, 44 115 8467307, Justine.Schneider@nottingham.ac.uk %K computers, cognitive therapy %K method acceptability %K depression %K workplace %K qualitative evaluation %D 2014 %7 28.03.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Little is known about the factors that influence acceptability of and adherence to online psychological interventions. Evidence is needed to guide further development of promising programs. Objective: Our goal was to investigate users’ views of two online approaches to self-help for depression: computerized cognitive behavior therapy (cCBT) and informational websites, in a workplace context. Computerized CBT offers an inexpensive and accessible alternative to face-to-face therapy, and employers have an interest in reducing the working time lost to depression or stress. Yet little is known about how employees, who have actual experience of using online approaches, judge the intervention as a process. Methods: The qualitative data reported here were collected within an online randomized controlled trial whose participants had diagnosable depression. The experimental intervention was a 5-week cCBT program called MoodGYM, and the control condition was five informational websites about mental health. Data were collected via online questionnaires. There was no evidence of the superiority of either in terms of treatment outcomes. In parallel, using brief rating scales and open-ended questions designed for this purpose, we examined the relative acceptability of each approach over time, including perceptions of cCBT compared to seeing a health care professional. Results: At least 60% of participants held online therapy to be at least as acceptable as seeing a professional about mental health issues, and they were more likely to retain this opinion over time if they used the interactive program, MoodGYM, rather than informational websites alone. Barriers to cCBT use fell into four categories: intrinsic, intrapersonal problems; extrinsic technical problems; generic issues mostly pertaining to perceptions of cCBT; and specific issues about the intervention or control condition. These indicate strategies for improving engagement. Conclusions: As first-aid for mild to moderate mental health problems, evidence-based computerized approaches have broad acceptability. This could be increased by attending to the barriers noted here and by proactively managing users’ expectations at individual and organizational levels. The findings have implications for occupational health providers and others addressing the needs of working-age adults with depression. They also raise methodological issues for online research. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 24529487; http://www.controlled-trials.com/ISRCTN24529487 (Archived by Webcite at http://www.webcitation.org/6O8cCL4mh). %M 24681717 %R 10.2196/jmir.2871 %U http://www.jmir.org/2014/3/e90/ %U https://doi.org/10.2196/jmir.2871 %U http://www.ncbi.nlm.nih.gov/pubmed/24681717 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 3 %P e93 %T Characterizing Periodic Messaging Interventions Across Health Behaviors and Media: Systematic Review %A De Leon,Elaine %A Fuentes,Laura W %A Cohen,Joanna E %+ Institute for Global Tobacco Control, Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, 2213 McElderry Street, 4th Floor, Baltimore, MD, 21205, United States, 1 410 955 3549, edeleon@jhsph.edu %K prompts %K periodic messaging %K health behavior %K review, systematic %D 2014 %7 25.03.2014 %9 Review %J J Med Internet Res %G English %X Background: Periodic prompts serve as tools for health behavior interventions to encourage and maintain behavior changes. Past literature reviews have examined periodic messages targeting specific behaviors (smoking, physical activity, diet, etc) or media (telephone, email, face-to-face, newsletter, etc) and have found them to be effective in impacting health behavior in the short term. Objective: Our goal was to review the literature related to periodic messaging and prompts in order to explore typical characteristics, assess the role of prompt timing, identify common theoretical models used, and identify characteristics associated with the effectiveness of periodic prompts. Methods: Electronic searches of PubMed, PsycINFO, CINAHL, and Web of Science were conducted in October 2012 and May 2013. Database search terms included variant terms for periods, prompts, interventions, media, and health behaviors. Results: Forty-two of the 55 included research articles found that prompts resulted in significant positive behavioral outcomes for participants. Prompts were delivered via text messages, email, mailed communications, and in a few instances via phone. Generally, the provision of feedback and specific strategies to accomplish behavior change appears to be important for the success of periodic prompts. Rationale for prompt timing was rarely provided, although some studies did organize message content around days of the week or times perceived to be high risk for particular behaviors. Smoking cessation interventions tended to be organized around quit date. Among studies using theoretical models to inform their interventions, the transtheoretical model was most common. Conclusions: Periodic messaging interventions yield positive results for short-term health behavior changes. Interventions including feedback and prompts that included strategies were more likely to report significantly positive outcomes. Work remains to better understand elements that make periodic prompts successful and whether they are effective in producing long-term outcomes. %M 24667840 %R 10.2196/jmir.2837 %U http://www.jmir.org/2014/3/e93/ %U https://doi.org/10.2196/jmir.2837 %U http://www.ncbi.nlm.nih.gov/pubmed/24667840 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 3 %P e87 %T Web-Based Intervention in Mindfulness Meditation for Reducing Residual Depressive Symptoms and Relapse Prophylaxis: A Qualitative Study %A Boggs,Jennifer M %A Beck,Arne %A Felder,Jennifer N %A Dimidjian,Sona %A Metcalf,Christina A %A Segal,Zindel V %+ Kaiser Permanente Colorado, Institute for Health Research, 10065 E Harvard Ave, Suite 300, Denver, CO, 80231, United States, 1 303 614 1368, Jennifer.m.boggs@kp.org %K mindfulness-based cognitive therapy %K online depression %K Web-based depression %K Internet-based depression %K depression relapse prevention %K residual depression symptoms %K online psychological treatment %K qualitative methods %D 2014 %7 24.03.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Mindful Mood Balance (MMB) is a Web-based intervention designed to treat residual depressive symptoms and prevent relapse. MMB was designed to deliver the core concepts of mindfulness-based cognitive therapy (MBCT), a group treatment, which, despite its strong evidence base, faces a number of dissemination challenges. Objective: The present study is a qualitative investigation of participants’ experiences with MMB. Methods: Qualitative content analysis was conducted via 38 exit interviews with MMB participants. Study inclusion required a current PHQ-9 (Patient Health Questionnaire) score ≤12 and lifetime history ≥1 major depressive episode. Feedback was obtained on specific website components, program content, and administration as well as skills learned. Results: Codes were assigned to interview responses and organized into four main themes: MBCT Web content, MBCT Web-based group process, home practice, and evidence of concept comprehension. Within these four areas, participants highlighted the advantages and obstacles of translating and delivering MBCT in a Web-based format. Adding increased support was suggested for troubleshooting session content as well as managing time challenges for completing home mindfulness practice. Participants endorsed developing affect regulation skills and identified several advantages to Web-based delivery including flexibility, reduced cost, and time commitment. Conclusions: These findings support the viability of providing MBCT online and are consistent with prior qualitative accounts derived from in-person MBCT groups. While there is certainly room for innovation in the domains of program support and engagement, the high levels of participant satisfaction indicated that MMB can significantly increase access to evidence-based psychological treatments for sub-threshold symptoms of unipolar affective disorder. %M 24662625 %R 10.2196/jmir.3129 %U http://www.jmir.org/2014/3/e87/ %U https://doi.org/10.2196/jmir.3129 %U http://www.ncbi.nlm.nih.gov/pubmed/24662625 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 3 %P e82 %T Efficacy of a Web-Based Computer-Tailored Smoking Prevention Intervention for Dutch Adolescents: Randomized Controlled Trial %A de Josselin de Jong,Sanne %A Candel,Math %A Segaar,Dewi %A Cremers,Henricus-Paul %A de Vries,Hein %+ Trimbos Institute (Netherlands Institute of Mental Health and Addiction), Da Costakade 45, PO Box 725, Utrecht, 3500 AS, Netherlands, 31 30 295 9239, sdejosselindejong@trimbos.nl %K computer tailoring %K Web-based intervention %K Internet %K smoking prevention %K smoking initiation %K adolescents %K randomized controlled trial %D 2014 %7 21.03.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Preventing smoking initiation among adolescents is crucial to reducing tobacco-caused death and disease. This study focuses on the effectiveness of a Web-based computer-tailored smoking prevention intervention aimed at adolescents. Objective: The intent of the study was to describe the intervention characteristics and to show the effectiveness and results of a randomized controlled trial. We hypothesized that the intervention would prevent smoking initiation among Dutch secondary school students aged 10-20 years and would have the largest smoking prevention effect among the age cohort of 14-16 years, as smoking uptake in that period is highest. Methods: The intervention consisted of a questionnaire and fully automated computer-tailored feedback on intention to start smoking and motivational determinants. A total of 89 secondary schools were recruited via postal mail and randomized into either the computer-tailored intervention condition or the control condition. Participants had to complete a Web-based questionnaire at baseline and at 6-month follow-up. Data on smoking initiation were collected from 897 students from these schools. To identify intervention effects, multilevel logistic regression analyses were conducted using multiple imputation. Results: Smoking initiation among students aged 10-20 years was borderline significantly lower in the experimental condition as compared to the control condition 6 months after baseline (OR 0.25, 95% CI 0.05-1.21, P=.09). Additional analyses of the data for the 14-16 year age group showed a significant effect, with 11.5% (24/209) of the students in the control condition reporting initiation compared to 5.7% (10/176) in the experimental condition (OR 0.22, 95% CI 0.05-1.02, P=.05). No moderation effects were found regarding gender and educational level. Conclusions: The findings of this study suggest that computer-tailored smoking prevention programs are a promising way of preventing smoking initiation among adolescents for at least 6 months, in particular among the age cohort of 14-16 years. Further research is needed to focus on long-term effects. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 77864351; http://www.controlled-trials.com/ISRCTN77864351 (Archived by WebCite at http://www.webcitation.org/6BSLKSTm5). %M 24657434 %R 10.2196/jmir.2469 %U http://www.jmir.org/2014/3/e82/ %U https://doi.org/10.2196/jmir.2469 %U http://www.ncbi.nlm.nih.gov/pubmed/24657434 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 3 %P e91 %T Economic Evaluation of a Web-Based Tailored Lifestyle Intervention for Adults: Findings Regarding Cost-Effectiveness and Cost-Utility From a Randomized Controlled Trial %A Schulz,Daniela N %A Smit,Eline S %A Stanczyk,Nicola E %A Kremers,Stef PJ %A de Vries,Hein %A Evers,Silvia MAA %+ CAPHRI School for Public Health and Primary Care, Department of Health Promotion, Maastricht University, P. Debyeplein 1, Maastricht, 6229HA, Netherlands, 31 433882832, dn.schulz@maastrichtuniversity.nl %K randomized controlled trial %K economic evaluation %K cost-effectiveness %K cost-utility %K lifestyle behaviors %K Internet interventions %K Web-based %K computer-tailoring %D 2014 %7 20.03.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Different studies have reported the effectiveness of Web-based computer-tailored lifestyle interventions, but economic evaluations of these interventions are scarce. Objective: The objective was to assess the cost-effectiveness and cost-utility of a sequential and a simultaneous Web-based computer-tailored lifestyle intervention for adults compared to a control group. Methods: The economic evaluation, conducted from a societal perspective, was part of a 2-year randomized controlled trial including 3 study groups. All groups received personalized health risk appraisals based on the guidelines for physical activity, fruit intake, vegetable intake, alcohol consumption, and smoking. Additionally, respondents in the sequential condition received personal advice about one lifestyle behavior in the first year and a second behavior in the second year; respondents in the simultaneous condition received personal advice about all unhealthy behaviors in both years. During a period of 24 months, health care use, medication use, absenteeism from work, and quality of life (EQ-5D-3L) were assessed every 3 months using Web-based questionnaires. Demographics were assessed at baseline, and lifestyle behaviors were assessed at both baseline and after 24 months. Cost-effectiveness and cost-utility analyses were performed based on the outcome measures lifestyle factor (the number of guidelines respondents adhered to) and quality of life, respectively. We accounted for uncertainty by using bootstrapping techniques and sensitivity analyses. Results: A total of 1733 respondents were included in the analyses. From a willingness to pay of €4594 per additional guideline met, the sequential intervention (n=552) was likely to be the most cost-effective, whereas from a willingness to pay of €10,850, the simultaneous intervention (n=517) was likely to be most cost-effective. The control condition (n=664) appeared to be preferred with regard to quality of life. Conclusions: Both the sequential and the simultaneous lifestyle interventions were likely to be cost-effective when it concerned the lifestyle factor, whereas the control condition was when it concerned quality of life. However, there is no accepted cutoff point for the willingness to pay per gain in lifestyle behaviors, making it impossible to draw firm conclusions. Further economic evaluations of lifestyle interventions are needed. Trial Registration: Dutch Trial Register NTR2168; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2168 (Archived by WebCite at http://www.webcitation.org/6MbUqttYB). %M 24650860 %R 10.2196/jmir.3159 %U http://www.jmir.org/2014/3/e91/ %U https://doi.org/10.2196/jmir.3159 %U http://www.ncbi.nlm.nih.gov/pubmed/24650860 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 3 %P e86 %T Do Email and Mobile Phone Prompts Stimulate Primary School Children to Reuse an Internet-Delivered Smoking Prevention Intervention? %A Cremers,Henricus-Paul %A Mercken,Liesbeth %A Crutzen,Rik %A Willems,Paul %A de Vries,Hein %A Oenema,Anke %+ School for Public Health and Primary Care (CAPHRI), Department of Health Promotion, Maastricht University, P. Debyeplein 1, Maastricht, 6229 HA, Netherlands, 31 43 388 2379, p.cremers@maastrichtuniversity.nl %K Internet %K Internet-delivered intervention %K prompts %K primary school children %K computer-tailoring %D 2014 %7 18.03.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Improving the use (eg, initial visit and revisits) of Internet-delivered interventions to promote healthy lifestyles such as non-smoking is one of the largest challenges in the field of eHealth. Prompts have shown to be effective in stimulating reuse of Internet-delivered interventions among adults and adolescents. However, evidence concerning effectiveness of prompts to promote reuse of a website among children is still scarce. Objective: The aim of this study is to investigate (1) whether prompts are effective in promoting reuse of an intervention website containing information on smoking prevention for children, (2) whether the content of the prompt is associated with its effect in terms of reuse, and (3) whether there are differences between children who do or do not respond to prompts. Methods: The sample of this cluster-randomized study consisted of 1124 children (aged 10-11 years) from 108 Dutch primary schools, who were assigned to the experimental group of an Internet-delivered smoking prevention intervention study. All participants completed a Web-based questionnaire on factors related to (non-)smoking. Schools were randomized to a no-prompt group (n=50) or a prompt group (n=58). All children could revisit the intervention website, but only the children in the prompt group received email and SMS prompts to revisit the website. Those prompt messages functioned as a teaser to stimulate reuse of the intervention website. Reuse of the website was objectively tracked by means of a server registration system. Repeated measures analysis of variance and linear regression analysis were performed to assess the effects of prompts on website reuse and to identify individual characteristics of participants who reuse the intervention website. Results: Children in the prompt group reused the intervention website significantly more often compared to children in the no-prompt group (B=1.56, P<.001). Prompts announcing new animated videos (F1,1122=9.33, P=.002) and games about (non-)smoking on the website (F1,1122=8.28, P=.004) resulted in most reuse of the website. Within the prompt group, children with a low socioeconomic status (SES) reused the intervention website more often (B=2.19, P<.001) than children of high SES (B=0.93, P=.005). Conclusions: Prompts can stimulate children to reuse an intervention website aimed at smoking prevention. Prompts showed, furthermore, to stimulate children of a low SES slightly more to reuse an intervention website, which is often a difficult target group in terms of stimulating participation. However, the number of revisits was quite low, which requires further study into how prompts can be optimized in terms of content and frequency to improve the number of revisits. Trial Registration: Netherlands Trial Register Number: NTR3116; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3116 (Archived by WebCite at http://www.webcitation.org/6O0wQYuPI). %M 24642082 %R 10.2196/jmir.3069 %U http://www.jmir.org/2014/3/e86/ %U https://doi.org/10.2196/jmir.3069 %U http://www.ncbi.nlm.nih.gov/pubmed/24642082 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 3 %P e77 %T An Internet- and Mobile-Based Tailored Intervention to Enhance Maintenance of Physical Activity After Cardiac Rehabilitation: Short-Term Results of a Randomized Controlled Trial %A Antypas,Konstantinos %A Wangberg,Silje C %+ Norwegian Centre for Integrated Care and Telemedicine, University Hospital of North Norway, PO Box 35, Tromsø, N-9038, Norway, 47 97613265, konstantinos.antypas@telemed.no %K rehabilitation %K cardiovascular diseases %K exercise therapy %K eHealth %K telemedicine %K Internet %K cellular phone %K self-management %K physical activity %K persuasive communication %K health behavior %D 2014 %7 11.03.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: An increase in physical activity for secondary prevention of cardiovascular disease and cardiac rehabilitation has multiple therapeutic benefits, including decreased mortality. Internet- and mobile-based interventions for physical activity have shown promising results in helping users increase or maintain their level of physical activity in general and specifically in secondary prevention of cardiovascular diseases and cardiac rehabilitation. One component related to the efficacy of these interventions is tailoring of the content to the individual. Objective: Our trial assessed the effect of a longitudinally tailored Internet- and mobile-based intervention for physical activity as an extension of a face-to-face cardiac rehabilitation stay. We hypothesized that users of the tailored intervention would maintain their physical activity level better than users of the nontailored version. Methods: The study population included adult participants of a cardiac rehabilitation program in Norway with home Internet access and a mobile phone. The participants were randomized in monthly clusters to a tailored or nontailored (control) intervention group. All participants had access to a website with information regarding cardiac rehabilitation, an online discussion forum, and an online activity calendar. Those using the tailored intervention received tailored content based on models of health behavior via the website and mobile fully automated text messages. The main outcome was self-reported level of physical activity, which was obtained using an online international physical activity questionnaire at baseline, at discharge, and at 1 month and 3 months after discharge from the cardiac rehabilitation program. Results: Included in the study were 69 participants. One month after discharge, the tailored intervention group (n=10) had a higher median level of overall physical activity (median 2737.5, IQR 4200.2) than the control group (n=14, median 1650.0, IQR 2443.5), but the difference was not significant (Kolmogorov-Smirnov Z=0.823, P=.38, r=.17). At 3 months after discharge, the tailored intervention group (n=7) had a significantly higher median level of overall physical activity (median 5613.0, IQR 2828.0) than the control group (n=12, median 1356.0, IQR 2937.0; Kolmogorov-Smirnov Z=1.397, P=.02, r=.33). The median adherence was 45.0 (95% CI 0.0-169.8) days for the tailored group and 111.0 (95% CI 45.1-176.9) days for the control group; however, the difference was not significant (P=.39). There were no statistically significant differences between the 2 groups in stage of change, self-efficacy, social support, perceived tailoring, anxiety, or depression. Conclusions: Because of the small sample size and the high attrition rate at the follow-up visits, we cannot make conclusions regarding the efficacy of our approach, but the results indicate that the tailored version of the intervention may have contributed to the long-term higher physical activity maintained after cardiac rehabilitation by participants receiving the tailored intervention compared with those receiving the nontailored intervention. Trial Registration: ClinicalTrials.gov: NCT01223170; http://clinicaltrials.gov/show/NCT01223170 (Archived by WebCite at http://www.webcitation.org/6Nch4ldcL). %M 24618349 %R 10.2196/jmir.3132 %U http://www.jmir.org/2014/3/e77/ %U https://doi.org/10.2196/jmir.3132 %U http://www.ncbi.nlm.nih.gov/pubmed/24618349 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 3 %P e72 %T Effectiveness of eHealth Interventions and Information Needs in Palliative Care: A Systematic Literature Review %A Capurro,Daniel %A Ganzinger,Matthias %A Perez-Lu,Jose %A Knaup,Petra %+ Evidence Based Health Care Program, Department of Internal Medicine, Escuela de Medicina, Pontificia Universidad Católica de Chile, Lira 63, Santiago, 8330074, Chile, 56 223543040, dcapurro@med.puc.cl %K palliative Care %K eHealth %K systematic review %D 2014 %7 07.03.2014 %9 Review %J J Med Internet Res %G English %X Background: One of the key components in palliative care is communication. eHealth technologies can be an effective way to support communications among participants in the process of palliative care. However, it is unclear to what extent information technology has been established in this field. Objective: Our goal was to systematically identify studies and analyze the effectiveness of eHealth interventions in palliative care and the information needs of people involved in the palliative care process. Methods: We conducted a systematic literature search using PubMed, Embase, and LILACS according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We collected and analyzed quantitative and qualitative data regarding effectiveness of eHealth interventions and users’ information needs in palliative care. Results: Our search returned a total of 240 articles, 17 of which met our inclusion criteria. We found no randomized controlled trial studying the effects of eHealth interventions in palliative care. Studies tended to be observational, noncontrolled studies, and a few quasi-experimental studies. Overall there was great heterogeneity in the types of interventions and outcome assessments; some studies reported some improvement on quality of care, documentation effort, cost, and communications. The most frequently reported information need concerned pain management. Conclusions: There is limited evidence around the effectiveness of eHealth interventions for palliative care patients, caregivers, and health care professionals. Focused research on information needs and high-quality clinical trials to assess their effectiveness are needed. %M 24610324 %R 10.2196/jmir.2812 %U http://www.jmir.org/2014/3/e72/ %U https://doi.org/10.2196/jmir.2812 %U http://www.ncbi.nlm.nih.gov/pubmed/24610324 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 3 %P e70 %T Supporting Self-Care for Families of Children With Eczema With a Web-Based Intervention Plus Health Care Professional Support: Pilot Randomized Controlled Trial %A Santer,Miriam %A Muller,Ingrid %A Yardley,Lucy %A Burgess,Hana %A Selinger,Hannah %A Stuart,Beth L %A Little,Paul %+ Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, United Kingdom, 44 2380241019, m.santer@soton.ac.uk %K child %K primary care %K randomized controlled trial %K eczema %K Internet %K self-care %D 2014 %7 04.03.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Childhood eczema, or childhood atopic dermatitis, causes significant distress to children and their families through sleep disturbance and itch. The main cause of treatment failure is nonuse of prescribed treatments. Objective: The objective of this study was to develop and test a Web-based intervention to support families of children with eczema, and to explore whether support from a health care professional (HCP) is necessary to engage participants with the intervention. Methods: We followed the PRECEDE-PROCEED model: regular emollient use was the target behavior we were seeking to promote and we identified potential techniques to influence this. LifeGuide software was used to write the intervention website. Carers of children with eczema were invited through primary care mail-out and randomized to 3 groups: (1) website only, (2) website plus HCP support, or (3) usual care. Patient-Oriented Eczema Measure (POEM) scores were measured online by carer report at baseline and at 12 weeks. Qualitative interviews were carried out with 13 HCPs (primarily practice nurses) and 26 participants to explore their experiences of taking part in the study. Results: A total of 143 carers were recruited through 31 practices. We found a decrease of ≥2 in follow-up compared with baseline POEM score in 23 of 42 (55%) participants in the website only group, 16 of 49 (33%) in the usual care group, and 18 of 47 (38%) in the website plus HCP group. Website use data showed that 75 of 93 (81%) participants allocated to the website groups completed the core modules, but less than half used other key components (videos: 35%; regular text reminders: 39%). There were no consistent differences in website use between the website only or the website plus HCP groups. Qualitative feedback showed that most HCPs had initial concerns about providing support for eczema self-care because this was not a condition that they felt expert in. However, HCPs reported productive consultations and that they found it helpful to use the website in consultations, while observing that some participants seemed to need more support than others. Qualitative interviews with participants suggested that HCP support was valued highly only by a minority, generally those who were less confident in their management of eczema or less confident using the Internet. Conclusions: Our pilot trial demonstrated the potential for greater improvements in POEM scores in both website intervention groups and that a full-scale trial is feasible. Such a trial would quantify the effectiveness and cost-effectiveness of this intervention to determine whether it should be widely promoted to families of children with newly diagnosed eczema. In this study population, HCP support was not strongly valued by participants and did not lead to better outcomes or website use than use of the Web-based intervention alone. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 98560867; http://www.controlled-trials.com/ISRCTN98560867 (Archived by WebCite at http://www.webcitation.org/6NcxvMtgN). %M 24594972 %R 10.2196/jmir.3035 %U http://www.jmir.org/2014/3/e70/ %U https://doi.org/10.2196/jmir.3035 %U http://www.ncbi.nlm.nih.gov/pubmed/24594972 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 3 %P e69 %T Comparison of Text and Video Computer-Tailored Interventions for Smoking Cessation: Randomized Controlled Trial %A Stanczyk,Nicola %A Bolman,Catherine %A van Adrichem,Mathieu %A Candel,Math %A Muris,Jean %A de Vries,Hein %+ School for Public Health and Primary Care (CAPHRI), Department of Health Promotion, Maastricht University, P Debyeplein 1, Maastricht, 6229 HA, Netherlands, 31 43 3882226, nicola.stanczyk@maastrichtuniversity.nl %K smoking cessation %K multiple computer tailoring %K delivery strategy %K educational level %K text messages %K video messages %D 2014 %7 03.03.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: A wide range of effective smoking cessation interventions have been developed to help smokers to quit. Smoking rates remain high, especially among people with a lower level of education. Multiple tailoring adapted to the individual’s readiness to quit and the use of visual messaging may increase smoking cessation. Objective: The results of video and text computer tailoring were compared with the results of a control condition. Main effects and differential effects for subgroups with different educational levels and different levels of readiness to quit were assessed. Methods: During a blind randomized controlled trial, smokers willing to quit within 6 months were assigned to a video computer tailoring group with video messages (n=670), a text computer tailoring group with text messages (n=708), or to a control condition with short generic text advice (n=721). After 6 months, effects on 7-day point prevalence abstinence and prolonged abstinence were assessed using logistic regression analyses. Analyses were conducted in 2 samples: (1) respondents (as randomly assigned) who filled in the baseline questionnaire and completed the first session of the program, and (2) a subsample of sample 1, excluding respondents who did not adhere to at least one further intervention session. In primary analyses, we used a negative scenario in which respondents lost to follow-up were classified as smokers. Complete case analysis and multiple imputation analyses were considered as secondary analyses. Results: In sample 1, the negative scenario analyses revealed that video computer tailoring was more effective in increasing 7-day point prevalence abstinence than the control condition (OR 1.45, 95% CI 1.09-1.94, P=.01). Video computer tailoring also resulted in significantly higher prolonged abstinence rates than controls among smokers with a low (ready to quit within 4-6 months) readiness to quit (OR 5.13, 95% CI 1.76-14.92, P=.003). Analyses of sample 2 showed similar results, although text computer tailoring was also more effective than control in realizing 7-day point prevalence abstinence. No differential effects were found for level of education. Complete case analyses and multiple imputation yielded similar results. Conclusions: In all analyses, video computer tailoring was effective in realizing smoking cessation. Furthermore, video computer tailoring was especially successful for smokers with a low readiness to quit smoking. Text computer tailoring was only effective for sample 2. Results suggest that video-based messages with personalized feedback adapted to the smoker’s motivation to quit might be effective in increasing abstinence rates for smokers with diverse educational levels. Trial Registration: Netherlands Trial Register: NTR3102; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3102 (Archived by WebCite at http://www.webcitation.org/6NS8xhzUV). %M 24589938 %R 10.2196/jmir.3016 %U http://www.jmir.org/2014/3/e69/ %U https://doi.org/10.2196/jmir.3016 %U http://www.ncbi.nlm.nih.gov/pubmed/24589938 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 2 %P e52 %T Attrition and Adherence in a Web-Based Distress Management Program for Implantable Cardioverter Defibrillator Patients (WEBCARE): Randomized Controlled Trial %A Habibović,Mirela %A Cuijpers,Pim %A Alings,Marco %A van der Voort,Pepijn %A Theuns,Dominic %A Bouwels,Leon %A Herrman,Jean-Paul %A Valk,Suzanne %A Pedersen,Susanne %+ Department of Psychology, University of Southern Denmark, Campusvej 55, Odense M, 5230, Denmark, 45 6550 7992, sspedersen@health.sdu.dk %K implantable cardioverter defibrillator %K Web-based interventions %K adherence %K dropout %K attrition %D 2014 %7 28.02.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: WEB-Based Distress Management Program for Implantable CARdioverter defibrillator Patients (WEBCARE) is a Web-based randomized controlled trial, designed to improve psychological well-being in patients with an implantable cardioverter defibrillator (ICD). As in other Web-based trials, we encountered problems with attrition and adherence. Objective: In the current study, we focus on the patient characteristics, reasons, and motivation of (1) completers, (2) those who quit the intervention, and (3) those who quit the intervention and the study in the treatment arm of WEBCARE. Methods: Consecutive first-time ICD patients from six Dutch referral hospitals were approached for participation. After signing consent and filling in baseline measures, patients were randomized to either the WEBCARE group or the Usual Care group. Results: The treatment arm of WEBCARE contained 146 patients. Of these 146, 34 (23.3%) completed the treatment, 88 (60.3%) dropped out of treatment but completed follow-up, and 24 (16.4%) dropped out of treatment and study. Results show no systematic differences in baseline demographic, clinical, or psychological characteristics between groups. A gradual increase in dropout was observed with 83.5% (122/146) completing the first lesson, while only 23.3% (34/146) eventually completed the whole treatment. Reasons most often given by patients for dropout were technical problems with the computer, time constraints, feeling fine, and not needing additional support. Conclusions: Current findings underline the importance of focusing on adherence and dropout, as this remains a significant problem in behavioral Web-based trials. Examining possibilities to address barriers indicated by patients might enhance treatment engagement and improve patient outcomes. Trial Registration: Clinicaltrials.gov: NCT00895700; http://www.clinicaltrials.gov/ct2/show/NCT00895700 (Archived by WebCite at http://www.webcitation.org/6NCop6Htz). %M 24583632 %R 10.2196/jmir.2809 %U http://www.jmir.org/2014/2/e52/ %U https://doi.org/10.2196/jmir.2809 %U http://www.ncbi.nlm.nih.gov/pubmed/24583632 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 2 %P e67 %T Routine Real-Time Cost-Effectiveness Monitoring of a Web-Based Depression Intervention: A Risk-Sharing Proposal %A Naveršnik,Klemen %A Mrhar,Aleš %+ Prototype Analytics, Sandoz Development Center, Lek Pharmaceuticals, SDC, Verovškova 57, Ljubljana, SI-1000, Slovenia, 386 1 5803459, klemen.naversnik@sandoz.com %K depression %K medical economics %K value-based purchasing %D 2014 %7 27.02.2014 %9 Viewpoint %J J Med Internet Res %G English %X Background: A new health care technology must be cost-effective in order to be adopted. If evidence regarding cost-effectiveness is uncertain, then the decision maker faces two choices: (1) adopt the technology and run the risk that it is less effective in actual practice, or (2) reject the technology and risk that potential health is forgone. A new depression eHealth service was found to be cost-effective in a previously published study. The results, however, were unreliable because it was based on a pilot clinical trial. A conservative decision maker would normally require stronger evidence for the intervention to be implemented. Objective: Our objective was to evaluate how to facilitate service implementation by shifting the burden of risk due to uncertainty to the service provider and ensure that the intervention remains cost-effective during routine use. Methods: We propose a risk-sharing scheme, where the service cost depends on the actual effectiveness of the service in real-life setting. Routine efficacy data can be used as the input to the cost-effectiveness model, which employs a mapping function to translate a depression specific score into quality-adjusted life-years. The latter is the denominator in the cost-effectiveness ratio calculation, required by the health care decision maker. The output of the model is a “value graph”, showing intervention value as a function of its observed (future) efficacy, using the €30,000 per quality-adjusted life-year (QALY) threshold. Results: We found that the eHealth service should improve the patient’s outcome by at least 11.9 points on the Beck Depression Inventory scale in order for the cost-effectiveness ratio to remain below the €30,000/QALY threshold. The value of a single point improvement was found to be between €200 and €700, depending on depression severity at treatment start. Value of the eHealth service, based on the current efficacy estimates, is €1900, which is significantly above its estimated cost (€200). Conclusions: The eHealth depression service is particularly suited to routine monitoring, since data can be gathered through the Internet within the service communication channels. This enables real-time cost-effectiveness evaluation and allows a value-based price to be established. We propose a novel pricing scheme where the price is set to a point in the interval between cost and value, which provides an economic surplus to both the payer and the provider. Such a business model will assure that a portion of the surplus is retained by the payer and not completely appropriated by the private provider. If the eHealth service were to turn out less effective than originally anticipated, then the price would be lowered in order to achieve the cost-effectiveness threshold and this risk of financial loss would be borne by the provider. %M 24583773 %R 10.2196/jmir.2592 %U http://www.jmir.org/2014/2/e67/ %U https://doi.org/10.2196/jmir.2592 %U http://www.ncbi.nlm.nih.gov/pubmed/24583773 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 2 %P e57 %T Healthy Weight Regulation and Eating Disorder Prevention in High School Students: A Universal and Targeted Web-Based Intervention %A Jones,Megan %A Taylor Lynch,Katherine %A Kass,Andrea E %A Burrows,Amanda %A Williams,Joanne %A Wilfley,Denise E %A Taylor,C Barr %+ Laboratory for the Study of Behavioral Medicine, Psychiatry and Behavioral Sciences, Stanford University School of Medicine, 401 Quarry Road, MC 5722, Stanford, CA, 94305-5722, United States, 1 650 223 5742, meganjones@stanford.edu %K healthy weight regulation %K universal and targeted delivery %K school-based intervention %K prevention %K adolescents %D 2014 %7 27.02.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Given the rising rates of obesity in children and adolescents, developing evidence-based weight loss or weight maintenance interventions that can be widely disseminated, well implemented, and are highly scalable is a public health necessity. Such interventions should ensure that adolescents establish healthy weight regulation practices while also reducing eating disorder risk. Objective: This study describes an online program, StayingFit, which has two tracks for universal and targeted delivery and was designed to enhance healthy living skills, encourage healthy weight regulation, and improve weight/shape concerns among high school adolescents. Methods: Ninth grade students in two high schools in the San Francisco Bay area and in St Louis were invited to participate. Students who were overweight (body mass index [BMI] >85th percentile) were offered the weight management track of StayingFit; students who were normal weight were offered the healthy habits track. The 12-session program included a monitored discussion group and interactive self-monitoring logs. Measures completed pre- and post-intervention included self-report height and weight, used to calculate BMI percentile for age and sex and standardized BMI (zBMI), Youth Risk Behavior Survey (YRBS) nutrition data, the Weight Concerns Scale, and the Center for Epidemiological Studies Depression Scale. Results: A total of 336 students provided informed consent and were included in the analyses. The racial breakdown of the sample was as follows: 46.7% (157/336) multiracial/other, 31.0% (104/336) Caucasian, 16.7% (56/336) African American, and 5.7% (19/336) did not specify; 43.5% (146/336) of students identified as Hispanic/Latino. BMI percentile and zBMI significantly decreased among students in the weight management track. BMI percentile and zBMI did not significantly change among students in the healthy habits track, demonstrating that these students maintained their weight. Weight/shape concerns significantly decreased among participants in both tracks who had elevated weight/shape concerns at baseline. Fruit and vegetable consumption increased for both tracks. Physical activity increased among participants in the weight management track, while soda consumption and television time decreased. Conclusions: Results suggest that an Internet-based, universally delivered, targeted intervention may support healthy weight regulation, improve weight/shape concerns among participants with eating disorders risk, and increase physical activity in high school students. Tailored content and interactive features to encourage behavior change may lead to sustainable improvements in adolescent health. %M 24583683 %R 10.2196/jmir.2995 %U http://www.jmir.org/2014/2/e57/ %U https://doi.org/10.2196/jmir.2995 %U http://www.ncbi.nlm.nih.gov/pubmed/24583683 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 2 %P e54 %T Surviving and Thriving With Cancer Using a Web-Based Health Behavior Change Intervention: Randomized Controlled Trial %A O'Carroll Bantum,Erin %A Albright,Cheryl L %A White,Kami K %A Berenberg,Jeffrey L %A Layi,Gabriela %A Ritter,Phillip L %A Laurent,Diana %A Plant,Katy %A Lorig,Kate %+ University of Hawaii Cancer Center, Cancer Prevention & Control, 701 Ilalo St, B4, Honolulu, HI, 96813, United States, 1 808 441 3491, ebantum@cc.hawaii.edu %K cancer survivors %K online interventions %K social support %D 2014 %7 24.02.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Given the substantial improvements in cancer screening and cancer treatment in the United States, millions of adult cancer survivors live for years following their initial cancer diagnosis and treatment. However, latent side effects can occur and some symptoms can be alleviated or managed effectively via changes in lifestyle behaviors. Objective: The purpose of this study was to test the effectiveness of a six-week Web-based multiple health behavior change program for adult survivors. Methods: Participants (n=352) were recruited from oncology clinics, a tumor registry, as well as through online mechanisms, such as Facebook and the Association of Cancer Online Resources (ACOR). Cancer survivors were eligible if they had completed their primary cancer treatment from 4 weeks to 5 years before enrollment. Participants were randomly assigned to the Web-based program or a delayed-treatment control condition. Results: In total, 303 survivors completed the follow-up survey (six months after completion of the baseline survey) and participants in the Web-based intervention condition had significantly greater reductions in insomnia and greater increases in minutes per week of vigorous exercise and stretching compared to controls. There were no significant changes in fruit and vegetable consumption or other outcomes. Conclusions: The Web-based intervention impacted insomnia and exercise; however, a majority of the sample met or exceeded national recommendations for health behaviors and were not suffering from depression or fatigue at baseline. Thus, the survivors were very healthy and well-adjusted upon entry and their ability to make substantial health behavior changes may have been limited. Future work is discussed, with emphasis placed on ways in which Web-based interventions can be more specifically analyzed for benefit, such as in regard to social networking. Trial Registration: Clinicaltrials.gov NCT00962494; http://www.clinicaltrials.gov/ct2/show/NCT00962494 (Archived by WebCite at http://www.webcitation.org/6NIv8Dc6Q). %M 24566820 %R 10.2196/jmir.3020 %U http://www.jmir.org/2014/2/e54/ %U https://doi.org/10.2196/jmir.3020 %U http://www.ncbi.nlm.nih.gov/pubmed/24566820 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 2 %P e58 %T Self-Directed Interventions to Promote Weight Loss: A Systematic Review of Reviews %A Tang,Jason %A Abraham,Charles %A Greaves,Colin %A Yates,Tom %+ University of Exeter Medical School, University of Exeter, St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, United Kingdom, 44 07969330607, C.Abraham@exeter.ac.uk %K weight loss %K obesity %K Internet %K eHealth %K home-based %K text message %K self-delivered %K intervention %K systematic review %D 2014 %7 19.02.2014 %9 Review %J J Med Internet Res %G English %X Background: A wide range of self-directed weight-loss interventions are available, providing users with a variety of tools delivered through various formats to regulate weight-related behavior patterns. However, it is unclear how effective self-directed interventions are and how they promote weight loss and weight maintenance. Objective: A systematic review of reviews was conducted to examine the effectiveness of such interventions and to identify intervention content associated with effectiveness. Methods: MEDLINE, Embase, PsycINFO, CINAHL, and the Cochrane Library for systematic reviews were searched from 2000-2012 for reviews of the effectiveness of self-directed interventions on weight loss and weight maintenance in adults. Two reviewers used predefined inclusion criteria to select relevant reviews and assess their quality using the Overview Quality Assessment Questionnaire (OQAQ). We extracted data on effectiveness and on relationships between intervention characteristics and effectiveness. Results: Twenty reviews were included and quality assessed. Findings relevant to self-directed interventions, including interactive websites, smartphone applications, and text messaging (short message service, SMS) were summarized. Findings were mixed but promising. For example, one review of Internet-based interventions found that, when used in conjunction with standard weight loss programs, these interventions resulted in a significant average increase in weight loss of 1.5 kg over evaluation periods. Unfortunately, only 7 of 20 reviews were of high methodological quality according to OQAQ scores, and only 4 employed meta-analyses. Few reviews linked intervention content to effectiveness. Conclusions: Current evidence suggests that self-directed interventions can independently promote weight loss and can augment interventions involving personal contact. Particular change techniques and delivery modes including individualized feedback, email counseling, and online social support appear to enhance effectiveness. Further reviews of the content of self-directed weight-loss intervention studies are needed to clarify which change techniques delivered through which delivery formats optimize intervention effectiveness. %M 24554464 %R 10.2196/jmir.2857 %U http://www.jmir.org/2014/2/e58/ %U https://doi.org/10.2196/jmir.2857 %U http://www.ncbi.nlm.nih.gov/pubmed/24554464 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 2 %P e51 %T Digital Asthma Self-Management Interventions: A Systematic Review %A Morrison,Deborah %A Wyke,Sally %A Agur,Karolina %A Cameron,Euan J %A Docking,Robert I %A MacKenzie,Alison M %A McConnachie,Alex %A Raghuvir,Vandana %A Thomson,Neil C %A Mair,Frances S %+ General Practice & Primary Care, Institute of Health & Wellbeing, College of Medical, Veterinary & Life Sciences, University of Glasgow, 1 Horselethill Road, Glasgow, G12 9LX, United Kingdom, 44 (0)141 330 8312, frances.mair@glasgow.ac.uk %K asthma %K self-management %K Internet %K eHealth %K systematic review %K patient education %D 2014 %7 18.02.2014 %9 Review %J J Med Internet Res %G English %X Background: Many people with asthma tolerate symptoms and lifestyle limitations unnecessarily by not utilizing proven therapies. Better support for self-management is known to improve asthma control, and increasingly the Internet and other digital media are being used to deliver that support. Objective: Our goal was to summarize current knowledge, evidenced through existing systematic reviews, of the effectiveness and implementation of digital self-management support for adults and children with asthma and to examine what features help or hinder the use of these programs. Methods: A comprehensive search strategy combined 3 facets of search terms: (1) online technology, (2) asthma, and (3) self-management/behavior change/patient experience. We undertook searches of 14 databases, and reference and citation searching. We included qualitative and quantitative systematic reviews about online or computerized interventions facilitating self-management. Title, abstract, full paper screening, and quality appraisal were performed by two researchers independently. Data extraction was undertaken using standardized forms. Results: A total of 3810 unique papers were identified. Twenty-nine systematic reviews met inclusion criteria: the majority were from the United States (n=12), the rest from United Kingdom (n=6), Canada (n=3), Portugal (n=2), and Australia, France, Spain, Norway, Taiwan, and Greece (1 each). Only 10 systematic reviews fulfilled pre-determined quality standards, describing 19 clinical trials. Interventions were heterogeneous: duration of interventions ranging from single use, to 24-hour access for 12 months, and incorporating varying degrees of health professional involvement. Dropout rates ranged from 5-23%. Four RCTs were aimed at adults (overall range 3-65 years). Participants were inadequately described: socioeconomic status 0/19, ethnicity 6/19, and gender 15/19. No qualitative systematic reviews were included. Meta-analysis was not attempted due to heterogeneity and inadequate information provision within reviews. There was no evidence of harm from digital interventions. All RCTs that examined knowledge (n=2) and activity limitation (n=2) showed improvement in the intervention group. Digital interventions improved markers of self care (5/6), quality of life (4/7), and medication use (2/3). Effects on symptoms (6/12) and school absences (2/4) were equivocal, with no evidence of overall benefits on lung function (2/6), or health service use (2/15). No specific data on economic analyses were provided. Intervention descriptions were generally brief making it impossible to identify which specific “ingredients” of interventions contribute most to improving outcomes. Conclusions: Digital self-management interventions show promise, with evidence of beneficial effects on some outcomes. There is no evidence about utility in those over 65 years and no information about socioeconomic status of participants, making understanding the “reach” of such interventions difficult. Digital interventions are poorly described within reviews, with insufficient information about barriers and facilitators to their uptake and utilization. To address these gaps, a detailed quantitative systematic review of digital asthma interventions and an examination of the primary qualitative literature are warranted, as well as greater emphasis on economic analysis within trials. %M 24550161 %R 10.2196/jmir.2814 %U http://www.jmir.org/2014/2/e51/ %U https://doi.org/10.2196/jmir.2814 %U http://www.ncbi.nlm.nih.gov/pubmed/24550161 %0 Journal Article %@ 2291-9279 %I JMIR Publications Inc. %V 2 %N 1 %P e3 %T Views of Young People in Rural Australia on SPARX, a Fantasy World Developed for New Zealand Youth With Depression %A Cheek,Colleen %A Bridgman,Heather %A Fleming,Theresa %A Cummings,Elizabeth %A Ellis,Leonie %A Lucassen,Mathijs FG %A Shepherd,Matthew %A Skinner,Timothy %+ Rural Clinical School, University of Tasmania, Private Bag 3513, Burnie, 7320, Australia, 61 364305922, Colleen.Cheek@utas.edu.au %K mental health %K stigma %K computer games %K youth %K rural health, computerized CBT %D 2014 %7 18.02.2014 %9 Original Paper %J JMIR Serious Games %G English %X Background: A randomized control trial demonstrated that a computerized cognitive behavioral therapy (cCBT) program (Smart, Positive, Active, Realistic, X-factor thoughts [SPARX]) was an appealing and efficacious treatment for depression for adolescents in New Zealand. Little is known about the acceptability of computerized therapy programs for rural Australians and the suitability of computerized programs developed in one cultural context when used in another country. Issues such as accents and local differences in health care access might mean adjustments to programs are required. Objective: This study sought to explore the acceptability of SPARX by youth in rural Australia and to explore whether and how young people would wish to access such a program. Methods: Focus groups and semistructured interviews were conducted with 16 young people attending two youth-focused community services in a small, rural Tasmanian town. An inductive data-driven approach was used to identify themes using the interview transcripts as the primary data source. Interpretation was supported by demographic data, observer notes, and content analysis. Results: Participants reported that young people want help for mental health issues but they have an even stronger need for controlling how they access services. In particular, they considered protecting their privacy in their small community to be paramount. Participants thought computerized therapy was a promising way to increase access to treatment for youth in rural and remote areas if offered with or without therapist support and via settings other than school. The design features of SPARX that were perceived to be useful, included the narrative structure of the program, the use of different characters, the personalization of an avatar, “socialization” with the Guide character, optional journaling, and the use of encouraging feedback. Participants did not consider (New Zealand) accents off-putting. Young people believed the SPARX program would appeal to those who play computer games generally, but may be less appealing for those who do not. Conclusions: The findings suggest that computerized therapy offered in ways that support privacy and choice can improve access to treatment for rural youth. Foreign accents and style may not be off-putting to teenage users when the program uses a playful fantasy genre, as it is consistent with their expectation of fantasy worlds, and it is in a medium with which they already have a level of competence. Rather, issues of engaging design and confidential access appeared to be more important. These findings suggest a proven tool once formally assessed at a local level can be adopted cross-nationally. %M 25659116 %R 10.2196/games.3183 %U http://games.jmir.org/2014/1/e3/ %U https://doi.org/10.2196/games.3183 %U http://www.ncbi.nlm.nih.gov/pubmed/25659116 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 2 %P e55 %T Quit Now? Quit Soon? Quit When You’re Ready? Insights About Target Quit Dates for Smoking Cessation From an Online Quit Date Tool %A Cobb,Caroline O %A Niaura,Raymond S %A Donaldson,Elisabeth A %A Graham,Amanda L %+ Schroeder Institute for Tobacco Research and Policy Studies, Legacy, 1724 Massachusetts Ave NW, Washington, DC, 20036, United States, 1 202 454 5938, agraham@legacyforhealth.org %K smoking cessation %K Internet %K quit date %K tobacco dependence %D 2014 %7 17.02.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Setting a target quit date (TQD) is often an important component in smoking cessation treatment, but ambiguity remains concerning the optimal timing (ie, quitting spontaneously versus delaying to prepare). Objective: We examined four questions about the timing of TQDs and smoking outcomes in secondary analyses of The iQUITT Study, a randomized trial of Internet and telephone treatment for cessation: (1) What are the characteristics of TQDs set using an online interactive quit date tool?, (2) What are the characteristics of individuals who use a quit date tool and do they differ from those who do not?, (3) Are there differences in smoker characteristics, treatment utilization, and cessation outcomes based TQD timing?, and (4) Is maintenance of an initial TQD predictive of abstinence or do changes to TQDs lead to cessation? Methods: A total of 825 adult current cigarette smokers were randomized to enhanced Internet or enhanced Internet plus telephone counseling. Latency to TQD in days was calculated as the date difference between the initial TQD and enhanced Internet registration; prospective TQD setters were stratified into four latency groups (0, 1-14, 15-28, 29+ days). Baseline variables, website utilization, and 3-month cessation outcomes were examined between prospective TQD groups. Desire and confidence to quit, number of TQDs, and website logins were tested as predictors of 30-day point prevalence abstinence (ppa) at 3 months (responder-only analyses). Classification and regression tree (CART) analysis explored interactions among baseline variables, website utilization, and latency to TQD as predictors of 30-day ppa. Results: There were few baseline differences between individuals who used the quit date tool and those who did not. Prospective TQDs were set as follows: registration day was 17.1% (73/427), 1-14 days was 37.7% (161/427), 15-28 days was 18.5% (79/427), and 29+ days was 26.7% (114/427). Participants with a TQD within 2 weeks had higher baseline self-efficacy scores but did not differ on smoking variables. Individuals whose TQD was the same day as registration had the highest logins, page views, number of TQDs set using the tool, and messages sent to other members. Logistic regression revealed a significant interaction between number of TQDs and website logins for 30-day ppa (P=.005). Among those with high logins, 41.8% (33/79) with 1 TQD were abstinent versus 25.9% (35/135) with 2+TQDs. Logins and self-efficacy predicted 30-day ppa in the CART model. Conclusions: TQD timing did not predict cessation outcomes in standard or exploratory analyses. Self-efficacy and an apparent commitment to an initial TQD were the components most highly related to abstinence but only via interactions with website utilization. Findings highlight the importance of feeling efficacious about handling specific smoking situations and engaging with treatment. Additional research focused on increasing engagement in Web-based cessation studies is needed. Trial Registration: ClinicalTrials.gov: NCT00282009; http://clinicaltrials.gov/show/NCT00282009 (Archived by WebCite at http://www.webcitation.org/6Kt7NrXDl). %M 24534139 %R 10.2196/jmir.3086 %U http://www.jmir.org/2014/2/e55/ %U https://doi.org/10.2196/jmir.3086 %U http://www.ncbi.nlm.nih.gov/pubmed/24534139 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 1 %P e8 %T A Web-Based Supportive Intervention for Families Living With Depression: Content Analysis and Formative Evaluation %A Stjernswärd,Sigrid %A Hansson,Lars %+ Department of Health Sciences, Lund University, Box 157, Lund, , Sweden, 46 46 2221904, sigrid.stjernsward@med.lu.se %K family caregivers %K depression %K online social networks %K social support %D 2014 %7 14.02.2014 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Relatives of people with a mental illness who live together can experience additional burdens that may require support. A Web-based tool including a psychoeducation module, a diary, and a password-protected forum was developed to support relatives of a person with depression. Objective: The objective of our study was to explore participants’ use of the Web-based tool, with focus on the forum, and to assess its potential health and psychosocial benefits. Methods: Twenty-five people participated in this explorative open trial. Self-rating instruments assessing caregiver burden, stigma, and the tool’s usability were analyzed with Carer QoL7-D, DISC-12, and a system usability scale. A summary measure of subjective burden was assessed with CarerQoL-VAS. The forum posts were studied using content analysis. Results: The majority reported fulfillment from their caregiving tasks (84%, 21/25), and had relational problems (76%, 19/25), their own mental health problems (72%, 18/25), support (72%, 18/25), and difficulties coordinating daily activities with caregiving (56%, 14/25). Most (72%, 18/25) reported having been able to use their inner strength to cope with stigma and discrimination, 64% (16/25) had concealed or hidden the person’s condition, and 40% (10/25) reported having been avoided or shunned by people who knew about the illness. Forty-eight percent (12/25) reported unfair treatment from family; 40% (10/25) in marriage or divorce and 36% (9/25) from mental health staff. Almost one-third (28%, 7/25) reported having stopped themselves from having a close personal relationship. Participants’ subjective assessment of the tool’s usability resulted in a mean of 61.5 (range, 22.5-90; possible total value 0-100; >70=good). Ten people participated in the forum; content analysis resulted in five categories describing relatives’ situations: balancing the caregiver’s role and relationship to the patient; their own lives and need for support; resources and patient advocacy; a looming shadow on leisure, social, and professional life; and interaction and social support. Conclusions: Further studies are needed to explore optimal ways of using Web-based tools to address support for relatives of a person with mental illness. Professional feedback may enhance the use and value of online communities. %M 24550185 %R 10.2196/resprot.3051 %U http://www.researchprotocols.org/2014/1/e8/ %U https://doi.org/10.2196/resprot.3051 %U http://www.ncbi.nlm.nih.gov/pubmed/24550185 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 2 %P e40 %T Are Health Behavior Change Interventions That Use Online Social Networks Effective? A Systematic Review %A Maher,Carol A %A Lewis,Lucy K %A Ferrar,Katia %A Marshall,Simon %A De Bourdeaudhuij,Ilse %A Vandelanotte,Corneel %+ Health and Use of Time Group, University of South Australia, GPO Box 2471, Adelaide, 5001, Australia, 61 8 8302 2315, carol.maher@unisa.edu.au %K systematic review %K social network %K behavior change %K intervention %K Internet %K physical activity %K weight loss %D 2014 %7 14.02.2014 %9 Review %J J Med Internet Res %G English %X Background: The dramatic growth of Web 2.0 technologies and online social networks offers immense potential for the delivery of health behavior change campaigns. However, it is currently unclear how online social networks may best be harnessed to achieve health behavior change. Objective: The intent of the study was to systematically review the current level of evidence regarding the effectiveness of online social network health behavior interventions. Methods: Eight databases (Scopus, CINAHL, Medline, ProQuest, EMBASE, PsycINFO, Cochrane, Web of Science and Communication & Mass Media Complete) were searched from 2000 to present using a comprehensive search strategy. Study eligibility criteria were based on the PICOS format, where “population” included child or adult populations, including healthy and disease populations; “intervention” involved behavior change interventions targeting key modifiable health behaviors (tobacco and alcohol consumption, dietary intake, physical activity, and sedentary behavior) delivered either wholly or in part using online social networks; “comparator” was either a control group or within subject in the case of pre-post study designs; “outcomes” included health behavior change and closely related variables (such as theorized mediators of health behavior change, eg, self-efficacy); and “study design” included experimental studies reported in full-length peer-reviewed sources. Reports of intervention effectiveness were summarized and effect sizes (Cohen’s d and 95% confidence intervals) were calculated wherever possible. Attrition (percentage of people who completed the study), engagement (actual usage), and fidelity (actual usage/intended usage) with the social networking component of the interventions were scrutinized. Results: A total of 2040 studies were identified from the database searches following removal of duplicates, of which 10 met inclusion criteria. The studies involved a total of 113,988 participants (ranging from n=10 to n=107,907). Interventions included commercial online health social network websites (n=2), research health social network websites (n=3), and multi-component interventions delivered in part via pre-existing popular online social network websites (Facebook n=4 and Twitter n=1). Nine of the 10 included studies reported significant improvements in some aspect of health behavior change or outcomes related to behavior change. Effect sizes for behavior change ranged widely from −0.05 (95% CI 0.45-0.35) to 0.84 (95% CI 0.49-1.19), but in general were small in magnitude and statistically non-significant. Participant attrition ranged from 0-84%. Engagement and fidelity were relatively low, with most studies achieving 5-15% fidelity (with one exception, which achieved 105% fidelity). Conclusions: To date there is very modest evidence that interventions incorporating online social networks may be effective; however, this field of research is in its infancy. Further research is needed to determine how to maximize retention and engagement, whether behavior change can be sustained in the longer term, and to determine how to exploit online social networks to achieve mass dissemination. Specific recommendations for future research are provided. %M 24550083 %R 10.2196/jmir.2952 %U http://www.jmir.org/2014/2/e40/ %U https://doi.org/10.2196/jmir.2952 %U http://www.ncbi.nlm.nih.gov/pubmed/24550083 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 2 %P e48 %T Motivational Interviewing in a Web-Based Physical Activity Intervention With an Avatar: Randomized Controlled Trial %A Friederichs,Stijn %A Bolman,Catherine %A Oenema,Anke %A Guyaux,Janneke %A Lechner,Lilian %+ Faculty of Psychology and Educational Sciences, Open University of the Netherlands, PO Box 2960, Heerlen, 6401 DL, Netherlands, 31 0045 5762197, stijn.friederichs@ou.nl %K motivational interviewing %K physical activity %K Internet %K avatar %D 2014 %7 13.02.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Developing Web-based physical activity (PA) interventions based on motivational interviewing (MI) could increase the availability and reach of MI techniques for PA promotion. Integrating an avatar in such an intervention could lead to more positive appreciation and higher efficacy of the intervention, compared to an intervention that is purely text-based. Objective: The present study aims to determine whether a Web-based PA intervention based on MI with an avatar results in more positive appreciation and higher effectiveness of the intervention, when compared to an intervention that is purely text-based. Methods: A three-arm randomized controlled trial was conducted, containing the following research conditions: (1) a Web-based PA intervention based on MI with an avatar, (2) a content-identical intervention without an avatar, and (3) a control condition that received no intervention. Measurements included PA behavior and process variables, measured at baseline, directly following the intervention and 1 month post intervention. Results: Both interventions significantly increased self-reported PA at 1 month, compared to the control condition (betaAVATARvsCONTROL=.39, P=.011; betaTEXTvsCONTROL=.44, P=.006). No distinctions were found regarding intervention effect on PA between both interventions. Similarly, the results of the process evaluation did not indicate any significant differences between both interventions. Due to the limited relational skills of the avatar in this study, it probably did not succeed in forming a stronger relationship with the user, over and above text alone. Conclusions: The findings suggest that avatars that do not strengthen the social relationship with the user do not enhance the intervention impact. Future research should determine whether Web-based PA interventions based on MI could benefit from inclusion of a virtual coach capable of more complex relational skills than used in the current study, such as responding in gesture to the user’s state and input. Trial Registration: Dutch Trial Register trial number: NTR3147; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3147 (Archived by WebCite at http://www.webcitation.org/6NCbwdUJX). %M 24550153 %R 10.2196/jmir.2974 %U http://www.jmir.org/2014/2/e48/ %U https://doi.org/10.2196/jmir.2974 %U http://www.ncbi.nlm.nih.gov/pubmed/24550153 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 2 %P e44 %T Smoking Cessation Apps for Smartphones: Content Analysis With the Self-Determination Theory %A Choi,Jounghwa %A Noh,Ghee-Young %A Park,Dong-Jin %+ Hallym University, 13406 Damheon Hall, 39 Hallymdaehak-gil, Chuncheon, , Korea, Republic Of, 82 33 248 1928, jhchoi@hallym.ac.kr %K medical informatics applications %K smoking cessation %K communication media %D 2014 %7 12.02.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Smartphones are increasingly receiving attention from public health scholars and practitioners as a means to assist individuals’ health management. A number of smartphone apps for smoking cessation are also available; however, little effort has been made to evaluate the content and functions of these apps employing a theoretical framework. Objective: The present study aims to analyze and evaluate the contents of smoking cessation apps available in South Korea employing the self-determination theory (SDT) as a theoretical framework for analysis. This study analyzes the extent to which smoking cessation apps have features that satisfy the basic needs identified in the SDT, which stimulate autonomous motivation. The type of motivational goal content manifested in the apps and how the goal content was framed are also explored. By assessing the features of smoking cessation apps based on the SDT, this study aims to offer direction for improvement for these apps. Methods: Out of 309 apps identified from the iTunes store and Google Play (excluding 27 duplications), 175 apps were randomly drawn and analyzed. The coding scheme was drafted by the authors based on the SDT and gain/loss framing theory and was further finely tuned through the process of coder training and by establishing intercoder reliability. Once the intercoder reliability was established, the coders divided up the rest of the sample and coded them independently. Results: The analysis revealed that most apps (94.3%, 165/175) had at least one feature that tapped at least 1 of the 3 basic needs. Only 18 of 175 apps (10.3%) addressed all 3 basic needs. For goal content, money (53.7%, 94/175) showed the highest frequency, followed by health (32.0%, 56/175), time (7.4%, 13/175), and appearance (1.1%, 2/175), suggesting that extrinsic goals are more dominantly presented in smoking cessation apps. For the framing of goal content, gain framing appeared more frequently (41.7%, 73/175). Conclusions: The results suggest that these smoking cessation apps may not sufficiently stimulate autonomous motivation; a small number of apps addressed all 3 basic needs suggested by the SDT (ie, autonomy, competence, and relatedness). The apps also tended to present extrinsic goal content (primarily in terms of money) over intrinsic ones (ie, health) by primarily adopting gain framing. Implications of these findings for public health practitioners and consumers are discussed. %M 24521881 %R 10.2196/jmir.3061 %U http://www.jmir.org/2014/2/e44/ %U https://doi.org/10.2196/jmir.3061 %U http://www.ncbi.nlm.nih.gov/pubmed/24521881 %0 Journal Article %@ 2291-9279 %I JMIR Publications Inc. %V 2 %N 1 %P e2 %T DietBet: A Web-Based Program that Uses Social Gaming and Financial Incentives to Promote Weight Loss %A Leahey,Tricia %A Rosen,Jamie %+ Brown Medical School, Department of Psychiatry and Human Behavior, The Miriam Hospital's Weight Control and Diabetes Research Center, 196 Richmond Street, Providence, RI, 02903, United States, 1 4017938947, tleahey@lifespan.org %K commercial weight loss %K Web-based intervention %K social gaming %K financial incentives %D 2014 %7 07.02.2014 %9 Original Paper %J JMIR Serious Games %G English %X Background: Web-based commercial weight loss programs are increasing in popularity. Despite their significant public health potential, there is limited research on the effectiveness of such programs. Objective: The objective of our study was to examine weight losses produced by DietBet and explore whether baseline and engagement variables predict weight outcomes. Methods: DietBet is a social gaming website that uses financial incentives and social influence to promote weight loss. Players bet money and join a game. All players have 4 weeks to lose 4% of their initial body weight. At enrollment, players can choose to share their participation on Facebook. During the game, players interact with one another and report their weight loss on the DietBet platform. At week 4, all players within each game who lose at least 4% of initial body weight are declared winners and split the pool of money bet at the start of the game. Official weigh-in procedures are used to verify weights at the start of the game and at the end. Results: From December 2012 to July 2013, 39,387 players (84.04% female, 33,101/39,387; mean weight 87.8kg, SD 22.6kg) competed in 1934 games. The average amount bet was US $27 (SD US $22). A total of 65.63% (25,849/39,387) provided a verified weight at the end of the 4-week competition. The average intention-to-treat weight loss was 2.6% (SD 2.3%). Winners (n=17,171) won an average of US $59 (SD US $35) and lost 4.9% (SD 1.0%) of initial body weight, with 30.68% (5268/17,171) losing 5% or more of their initial weight. Betting more money at game entry, sharing on Facebook, completing more weigh-ins, and having more social interactions during the game predicted greater weight loss and greater likelihood of winning (Ps<.001). In addition, weight loss clustered within games (P<.001), suggesting that players influenced each others’ weight outcomes. Conclusions: DietBet, a social gaming website, reached nearly 40,000 individuals in just 7 months and produced excellent 4-week weight loss results. Given its reach and potential public health impact, future research may consider examining whether a longer program promotes additional weight loss. %M 25658966 %R 10.2196/games.2987 %U http://games.jmir.org/2014/1/e2/ %U https://doi.org/10.2196/games.2987 %U http://www.ncbi.nlm.nih.gov/pubmed/25658966 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 2 %P e42 %T Designing Messaging to Engage Patients in an Online Suicide Prevention Intervention: Survey Results From Patients With Current Suicidal Ideation %A Whiteside,Ursula %A Lungu,Anita %A Richards,Julie %A Simon,Gregory E %A Clingan,Sarah %A Siler,Jaeden %A Snyder,Lorilei %A Ludman,Evette %+ Group Health Research Institute, 1730 Minor Ave Suite 1500, Seattle, WA, , United States, 1 206 287 2100, whiteside.u@ghc.org %K human centered design %K user centered design %K health 2.0 %K suicide %D 2014 %7 07.02.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Computerized, Internet-delivered interventions can be efficacious; however, uptake and maintaining sustained client engagement are still big challenges. We see the development of effective engagement strategies as the next frontier in online health interventions, an area where much creative research has begun. We also argue that for engagement strategies to accomplish their purpose with novel targeted populations, they need to be tailored to such populations (ie, content is designed with the target population in mind). User-centered design frameworks provide a theoretical foundation for increasing user engagement and uptake by including users in development. However, deciding how to implement this approach to enage users in mental health intervention development is challenging. Objective: The aim of this study was to get user input and feedback on acceptability of messaging content intended to engage suicidal individuals. Methods: In March 2013, clinic intake staff distributed flyers announcing the study, “Your Feedback Counts” to potential participants (individuals waiting to be seen for a mental health appointment) together with the Patient Health Questionnaire. The flyer explained that a score of two or three (“more than half the days” or “nearly every day” respectively) on the suicide ideation question made them eligible to provide feedback on components of a suicide prevention intervention under development. The patient could access an anonymous online survey by following a link. After providing consent online, participants completed the anonymous survey. Results: Thirty-four individuals provided data on past demographic information. Participants reported that they would be most drawn to an intervention where they knew that they were cared about, that was personalized, that others like them had found it helpful, and that included examples with real people. Participants preferred email invitations with subject lines expressing concern and availability of extra resources. Participants also provided feedback about a media prototype including a brand design and advertisement video for introducing the intervention. Conclusions: This paper provides one model (including development of an engagement survey, audience for an engagement survey, methods for presenting results of an engagement survey) for including target users in the development of uptake strategies for online mental health interventions. %R 10.2196/jmir.3173 %U http://www.jmir.org/2014/2/e42/ %U https://doi.org/10.2196/jmir.3173 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 1 %P e25 %T Perceptions of Successful Cues to Action and Opportunities to Augment Behavioral Triggers in Diabetes Self-Management: Qualitative Analysis of a Mobile Intervention for Low-Income Latinos With Diabetes %A Burner,Elizabeth R %A Menchine,Michael D %A Kubicek,Katrina %A Robles,Marisela %A Arora,Sanjay %+ Keck School of Medicine of the University of Southern California, Department of Emergency Medicine, 1200 N State St, Room 1011, Los Angeles, CA, 90033, United States, 1 3232266667, eburner@usc.edu %K diabetes %K Latinos %K cellular phone %D 2014 %7 29.01.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: The increasing prevalence of diabetes and the associated cost of managing this complicated disease have a significant impact on public health outcomes and health expenditures, especially among resource-poor Latino patients. Mobile health (mHealth) may be the solution to reaching this group and improving their health. Objective: In this qualitative study, we examined nuances of motivation, intention, and triggers to action effected by TExT-MED (Trial to Examine Text Messaging for Emergency Department patient with Diabetes), an mHealth intervention tailored to low-income, urban Latinos with diabetes. TExT-MED is a fully-automated, text message-based program designed to increase knowledge, self-efficacy, and subsequent disease management and glycemic control. Methods: We conducted 5 focus group interviews with 24 people who participated in TExT-MED. We employed a modified grounded theory analytic approach—an iterative process of coding and immersion in the data used to recognize the patterns and links between concepts voiced by the participants. We coded data to identify themes of participant experiences, motivations, and responses to the program. We organized themes into a theory of TExT-MED’s action. Results: Participants enjoyed their experience with TExT-MED and believed it improved their diabetes management. Through analysis of the transcripts, we identified that the strengths of the program were messages that cued specific behaviors such as medication reminders and challenge messages. Our analysis also revealed that increasing personalization of message delivery and content could augment these cues. Conclusions: This in-depth qualitative analysis of TExT-MED shows that low-income Latino patients will accept text messages as a behavioral intervention. This mHealth intervention acts as a behavioral trigger rather than an education platform. Personalization is an opportunity to enhance these cues to action and further research should be conducted on the ideal forms of personalization. %M 24476784 %R 10.2196/jmir.2881 %U http://www.jmir.org/2014/1/e25/ %U https://doi.org/10.2196/jmir.2881 %U http://www.ncbi.nlm.nih.gov/pubmed/24476784 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 1 %P e26 %T Effects of a Web-Based Tailored Multiple-Lifestyle Intervention for Adults: A Two-Year Randomized Controlled Trial Comparing Sequential and Simultaneous Delivery Modes %A Schulz,Daniela N %A Kremers,Stef PJ %A Vandelanotte,Corneel %A van Adrichem,Mathieu JG %A Schneider,Francine %A Candel,Math JJM %A de Vries,Hein %+ CAPHRI School for Public Health and Primary Care, Department of Health Promotion, Maastricht University, P Debyeplein 1, Maastricht, 6229 HA, Netherlands, 31 43 388 2832, dn.schulz@maastrichtuniversity.nl %K multiple behavior change %K Web-based intervention %K computer tailoring %K effectiveness %K physical activity %K fruit consumption %K vegetable consumption %K alcohol intake %K smoking %D 2014 %7 27.01.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based computer-tailored interventions for multiple health behaviors can have a significant public health impact. Yet, few randomized controlled trials have tested this assumption. Objective: The objective of this paper was to test the effects of a sequential and simultaneous Web-based tailored intervention on multiple lifestyle behaviors. Methods: A randomized controlled trial was conducted with 3 tailoring conditions (ie, sequential, simultaneous, and control conditions) in the Netherlands in 2009-2012. Follow-up measurements took place after 12 and 24 months. The intervention content was based on the I-Change model. In a health risk appraisal, all respondents (N=5055) received feedback on their lifestyle behaviors that indicated whether they complied with the Dutch guidelines for physical activity, vegetable consumption, fruit consumption, alcohol intake, and smoking. Participants in the sequential (n=1736) and simultaneous (n=1638) conditions received tailored motivational feedback to change unhealthy behaviors one at a time (sequential) or all at the same time (simultaneous). Mixed model analyses were performed as primary analyses; regression analyses were done as sensitivity analyses. An overall risk score was used as outcome measure, then effects on the 5 individual lifestyle behaviors were assessed and a process evaluation was performed regarding exposure to and appreciation of the intervention. Results: Both tailoring strategies were associated with small self-reported behavioral changes. The sequential condition had the most significant effects compared to the control condition after 12 months (T1, effect size=0.28). After 24 months (T2), the simultaneous condition was most effective (effect size=0.18). All 5 individual lifestyle behaviors changed over time, but few effects differed significantly between the conditions. At both follow-ups, the sequential condition had significant changes in smoking abstinence compared to the simultaneous condition (T1 effect size=0.31; T2 effect size=0.41). The sequential condition was more effective in decreasing alcohol consumption than the control condition at 24 months (effect size=0.27). Change was predicted by the amount of exposure to the intervention (total visiting time: beta=–.06; P=.01; total number of visits: beta=–.11; P<.001). Both interventions were appreciated well by respondents without significant differences between conditions. Conclusions: Although evidence was found for the effectiveness of both programs, no simple conclusive finding could be drawn about which intervention mode was more effective. The best kind of intervention may depend on the behavior that is targeted or on personal preferences and motivation. Further research is needed to identify moderators of intervention effectiveness. The results need to be interpreted in view of the high and selective dropout rates, multiple comparisons, and modest effect sizes. However, a large number of people were reached at low cost and behavioral change was achieved after 2 years. Trial Registration: Nederlands Trial Register: NTR 2168; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2168 (Archived by WebCite at http://www.webcitation.org/6MbUqttYB). %M 24472854 %R 10.2196/jmir.3094 %U http://www.jmir.org/2014/1/e26/ %U https://doi.org/10.2196/jmir.3094 %U http://www.ncbi.nlm.nih.gov/pubmed/24472854 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 1 %P e17 %T Effectiveness of Web-Based Tailored Advice on Parents’ Child Safety Behaviors: Randomized Controlled Trial %A van Beelen,Mirjam Elisabeth Johanna %A Beirens,Tinneke Monique Jozef %A den Hertog,Paul %A van Beeck,Eduard Ferdinand %A Raat,Hein %+ Erasmus MC – University Medical Centre Rotterdam, Department of Public Health, Postbox 2040, Rotterdam, 3000 CA, Netherlands, 31 10 703 8580, h.raat@erasmusmc.nl %K child %K eHealth %K injury %K parent %K prevention %K primary care %K RCT %K safety %D 2014 %7 24.01.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Injuries at home are a major cause of death, disability, and loss of quality of life among young children. Despite current safety education, required safety behavior of parents is often lacking. To prevent various childhood disorders, the application of Web-based tools has increased the effectiveness of health promotion efforts. Therefore, an intervention with Web-based, tailored, safety advice combined with personal counseling (E-Health4Uth home safety) was developed and applied. Objective: To evaluate the effect of E-Health4Uth home safety on parents’ safety behaviors with regard to the prevention of falls, poisoning, drowning, and burns. Methods: A randomized controlled trial was conducted (2009-2011) among parents visiting well-baby clinics in the Netherlands. Parents were randomly assigned to the intervention group (E-Health4Uth home safety intervention) or to the control condition consisting of usual care. Parents in the intervention condition completed a Web-based safety behavior assessment questionnaire; the resulting tailored safety advice was discussed with their child health care professional at a well-baby visit (age approximately 11 months). Parents in the control condition received counseling using generic safety information leaflets at this well-baby visit. Parents’ child safety behaviors were derived from self-report questionnaires at baseline (age 7 months) and at follow-up (age 17 months). Each specific safety behavior was classified as safe/unsafe and a total risk score was calculated. Logistic and linear regression analyses were used to reveal differences in safety behavior between the intervention and the control condition at follow-up. Results: A total of 1292 parents (response rate 44.79%) were analyzed. At follow-up, parents in the intervention condition (n=643) showed significantly less unsafe behavior compared to parents in the control condition (n=649): top of staircase (23.91% vs 32.19%; OR 0.65, 95% CI 0.50-0.85); bottom of staircase (63.53% vs 71.94%; OR 0.69, 95% CI 0.53-0.88); top and bottom of staircase (68.94% vs 78.28%; OR 0.62, 95% CI 0.48-0.81); storage of cleaning products (30.33% vs 39.91%; OR 0.67, 95% CI 0.53-0.85); bathing of the child (23.46% vs 32.25%; OR 0.65, 95% CI 0.51-0.84); drinking hot fluids (34.84% vs 41.73%; OR 0.76, 95% CI 0.61-0.96); using rear hotplates (79.34% vs 85.27%; OR 0.67, 95% CI 0.50-0.90); and the total risk score in which a higher score indicates more unsafe behavior (mean 13.63, SD 6.12 vs mean 15.34, SD 6.07; beta –1.59, 95% CI –2.26 to –0.93). There were no significant differences for other specific behaviors between the two study conditions. Conclusions: Compared to generic written materials, the E-Health4Uth home safety intervention seems more effective in promoting parents’ safety behavior for safe staircases, storage of cleaning products, bathing, drinking hot fluids, and cooking. This study supports the application of Web-based, tailored, safety advice for the prevention of unintentional injuries in the youth health care setting. Trial Registration: Nederlands Trial Register: NTR1836; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1836 (Archived by WebCite at http://www.webcitation.org/6MPIGQxpx). %M 24463421 %R 10.2196/jmir.2521 %U http://www.jmir.org/2014/1/e17/ %U https://doi.org/10.2196/jmir.2521 %U http://www.ncbi.nlm.nih.gov/pubmed/24463421 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 1 %P e7 %T Skin Self-Examination Education for Early Detection of Melanoma: A Randomized Controlled Trial of Internet, Workbook, and In-Person Interventions %A Robinson,June K %A Gaber,Rikki %A Hultgren,Brittney %A Eilers,Steven %A Blatt,Hanz %A Stapleton,Jerod %A Mallett,Kimberly %A Turrisi,Rob %A Duffecy,Jenna %A Begale,Mark %A Martini,Mary %A Bilimoria,Karl %A Wayne,Jeffrey %+ Northwestern University, Department of Dermatology, Feinberg School of Medicine, Arkes Family Pavilion, Suite 1260, 676 N St Clair St, Chicago, IL, 60611, United States, 1 312 926 7449, june-robinson@northwestern.edu %K melanoma %K early detection of cancer %K educational techniques %K health education %K behavioral research %K online education %K electronic interactive education %D 2014 %7 13.1.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Early detection of melanoma improves survival. Since many melanoma patients and their spouses seek the care of a physician after discovering their melanoma, an ongoing study will determine the efficacy of teaching at-risk melanoma patients and their skin check partner how to conduct skin self-examinations (SSEs). Internet-based health behavior interventions have proven efficacious in creating behavior change in patients to better prevent, detect, or cope with their health issues. The efficacy of electronic interactive SSE educational intervention provided on a tablet device has not previously been determined. Objective: The electronic interactive educational intervention was created to develop a scalable, effective intervention to enhance performance and accuracy of SSE among those at-risk to develop melanoma. The intervention in the office was conducted using one of the following three methods: (1) in-person through a facilitator, (2) with a paper workbook, or (3) with a tablet device used in the clinical office. Differences related to method of delivery were elucidated by having the melanoma patient and their skin check partner provide a self-report of their confidence in performing SSE and take a knowledge-based test immediately after receiving the intervention. Methods: The three interventions used 9 of the 26 behavioral change techniques defined by Abraham and Michie to promote planning of monthly SSE, encourage performing SSE, and reinforce self-efficacy by praising correct responses to knowledge-based decision making and offering helpful suggestions to improve performance. In creating the electronic interactive SSE educational intervention, the educational content was taken directly from both the scripted in-person presentation delivered with Microsoft PowerPoint by a trained facilitator and the paper workbook training arms of the study. Enrollment totaled 500 pairs (melanoma patient and their SSE partner) with randomization of 165 pairs to the in-person, 165 pairs to the workbook, and 70 pairs to electronic interactive SSE educational intervention. Results: The demographic survey data showed no significant mean differences between groups in age, education, or income. The tablet usability survey given to the first 30 tablet pairs found that, overall, participants found the electronic interactive intervention easy to use and that the video of the doctor-patient-partner dialogue accompanying the dermatologist’s examination was particularly helpful in understanding what they were asked to do for the study. The interactive group proved to be just as good as the workbook group in self-confidence of scoring moles, and just as good as both the workbook and the in-person intervention groups in self-confidence of monitoring their moles. While the in-person intervention performed significantly better on a skill-based quiz, the electronic interactive group performed significantly better than the workbook group. The electronic interactive and in-person interventions were more efficient (30 minutes), while the workbook took longer (45 minutes). Conclusions: This study suggests that an electronic interactive intervention can deliver skills training comparable to other training methods, and the experience can be accommodated during the customary outpatient office visit with the physician. Further testing of the electronic interactive intervention’s role in the anxiety of the pair and pair-discovered melanomas upon self-screening will elucidate the impact of these tools on outcomes in at-risk patient populations. ClinicalTrial: ClinicalTrials.gov NCT01013844; http://clinicaltrials.gov/show/NCT01013844 (Archived by WebCite at http://www.webcitation.org/6LvGGSTKK). %R 10.2196/jmir.2883 %U http://www.jmir.org/2014/1/e7/ %U https://doi.org/10.2196/jmir.2883 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 1 %P e5 %T Using Ecological Momentary Assessment to Test the Effectiveness of a Web-Based Brief Alcohol Intervention Over Time Among Heavy-Drinking Students: Randomized Controlled Trial %A Voogt,Carmen %A Kuntsche,Emmanuel %A Kleinjan,Marloes %A Poelen,Evelien %A Engels,Rutger %+ Behavioural Science Institute, Radboud University Nijmegen, Montessorilaan 3, Nijmegen, 9104 6500 HE, Netherlands, 31 24 36 12705, c.voogt@bsi.ru.nl %K intervention study %K drinking %K students %D 2014 %7 08.01.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based brief alcohol interventions are effective in reducing alcohol use among students when measured at limited follow-up time points. To date, no studies have tested Web-based brief alcohol intervention effectiveness over time by using a large number of measurements. Objective: Testing whether the What Do You Drink (WDYD) Web-based brief alcohol intervention can sustain a reduction in alcohol use among heavy-drinking students aged 18-24 years at 1-, 3-, and 6-month follow-up intervals. Methods: A purely Web-based, 2-arm, parallel-group randomized controlled trial applying an ecological momentary assessment approach with 30 weekly measurements was conducted in the Netherlands (2010-2011). Participants were recruited offline and online. A total of 907 participants were randomized into the experimental condition (n=456) including the single-session and fully automated WDYD intervention, or into the control condition (n=451) including assessment only. Weekly alcohol consumption and frequency of binge drinking were the self-assessed outcome measures. Results: Attrition rates of the 907 participants were 110 (12.1%), 130 (14.3%), and 162 (17.9%) at 1-, 3-, and 6-month follow-up intervals, respectively. Latent growth curve analyses according to the intention-to-treat principle revealed that participants in the experimental condition had significantly lower weekly alcohol consumption compared to participants in the control condition that was sustained at 3-month follow-up (intercept=–2.60, P<.001; slope=0.16, P=.08). Additional linear regression analyses indicated that this intercept difference resulted from significantly higher levels of alcohol units per week for participants in the control condition compared to those in the experimental condition at 1-month (beta=–2.56, SE 0.74, Cohen’s d=0.20, P=.001), 3-month (beta=–1.76, SE 0.60, Cohen’s d=0.13, P=.003), and 6-month (beta=–1.21, SE 0.58, Cohen’s d=0.09, P=.04) follow-up intervals. Latent growth curve analyses further indicated that participants in the experimental condition had a significantly lower frequency of binge drinking compared to participants in the control condition that was sustained at 6-month follow-up (intercept=–0.14, P=.01; slope=0.004, P=.19). This intercept difference resulted from higher levels in this outcome for participants in the control condition relative to participants in the experimental condition at 1-month (beta=–1.15, SE 0.06, Cohen’s d=0.16, P=.01), 3-month (beta=–0.12, SE 0.05, Cohen’s d=0.09, P=.01), and 6-month (beta=–0.09, SE 0.05, Cohen’s d=0.03, P=.045) follow-up intervals. Conclusions: The WDYD intervention was shown to be effective in preventing an increase in weekly alcohol consumption and frequency of binge drinking directly after the intervention. This effect was sustained 3 and 6 months after the intervention. Trial Registration: Netherlands Trial Register NTR2665; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2665 (Archived by WebCite at http://webcitation.org/6LuQVn12M). %M 24401555 %R 10.2196/jmir.2817 %U http://www.jmir.org/2014/1/e5/ %U https://doi.org/10.2196/jmir.2817 %U http://www.ncbi.nlm.nih.gov/pubmed/24401555 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 1 %P e2 %T Examining Participant Engagement in an Information Technology-Based Physical Activity and Nutrition Intervention for Men: The Manup Randomized Controlled Trial %A Short,Camille E %A Vandelanotte,Corneel %A Dixon,Marcus W %A Rosenkranz,Richard %A Caperchione,Cristina %A Hooker,Cindy %A Karunanithi,Mohan %A Kolt,Gregory S %A Maeder,Anthony %A Ding,Hang %A Taylor,Pennie %A Duncan,Mitch J %+ Center for Physical Activity Studies, Institute for Health and Social Science Research, Central Queensland University, Building 18, Bruce Highway, Rockhampton, 4702, Australia, 61 749232689, c.short@cqu.edu.au %K qualitative %K intervention %K physical activity %K retention %K technology %K website %K engagement %D 2014 %7 03.01.2014 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Males experience a shorter life expectancy and higher rates of chronic diseases compared to their female counterparts. To improve health outcomes among males, interventions specifically developed for males that target their health behaviors are needed. Information technology (IT)-based interventions may be a promising intervention approach in this population group, however, little is known about how to maximize engagement and retention in Web-based programs. Objective: The current study sought to explore attributes hypothesized to influence user engagement among a subsample of participants from the ManUp study, a randomized controlled trial testing the efficacy of an interactive Web-based intervention for promoting physical activity and nutrition among middle-aged males. Methods: Semistructured interviews were conducted and audiotaped with 20 of the ManUp participants. Interview questions were based on a conceptual model of engagement and centered on why participants took part in the study, what they liked and did not like about the intervention they received, and how they think the intervention could be improved. Interview recordings were transcribed and coded into themes. Results: There were five themes that were identified in the study. These themes were: (1) users’ motives, (2) users’ desired outcomes, (3) users’ positive experiences, (4) users’ negative emotions, and (5) attributes desired by user. Conclusions: There is little research in the field that has explored user experiences in human-computer interactions and how such experiences may relate to engagement, especially among males. Although not conclusive, the current study provides some insight into what personal attributes of middle-aged males (such as their key motives and goals for participating) and attributes of the intervention materials (such as usability, control, and interactivity) may impact on user engagement in this group. These findings will be helpful for informing the design and implementation of future health behavior interventions for males. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12611000081910; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000081910 (Archived by WebCite at http://www.webcitation.org/6M4lBlvCA). %M 24389361 %R 10.2196/resprot.2776 %U http://www.researchprotocols.org/2014/1/e2/ %U https://doi.org/10.2196/resprot.2776 %U http://www.ncbi.nlm.nih.gov/pubmed/24389361 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 12 %P e279 %T Use of Behavioral Change Techniques in Web-Based Self-Management Programs for Type 2 Diabetes Patients: Systematic Review %A van Vugt,Michael %A de Wit,Maartje %A Cleijne,Wilmy HJJ %A Snoek,Frank J %+ Department of Medical Psychology, VU University Medical Centre, MF-D345, Van der Boechorststraat 7, Amsterdam, 1081 BT, Netherlands, 31 204446099, m.vanvugt@vumc.nl %K Web-based %K online %K self-management %K review %K type 2 diabetes mellitus %K behavioral change techniques %D 2013 %7 13.12.2013 %9 Review %J J Med Internet Res %G English %X Background: Type 2 diabetes mellitus (T2DM) is a highly prevalent chronic metabolic disease characterized by hyperglycemia and cardiovascular risks. Without proper treatment, T2DM can lead to long-term complications. Diabetes self-management is recognized as the cornerstone of overall diabetes management. Web-based self-management programs for T2DM patients can help to successfully improve patient health behaviors and health-related outcomes. Theories can help to specify key determinants of the target behaviors and behavior change strategies required to arrive at the desired health outcomes, which can then be translated into specific behavioral techniques or strategies that patients can learn to apply in their daily life. From previous reviews of a wide range of online diabetes self-management tools and programs, it appears that it is still unclear which behavioral change techniques (BCTs) are primarily used and are most effective when it comes to improving diabetes self-management behaviors and related health outcomes. Objective: We set out to identify which BCTs are being applied in online self-management programs for T2DM and whether there is indication of their effectiveness in relation to predefined health outcomes. Methods: Articles were systematically searched and screened on the mentioned use of 40 BCTs, which were then linked to reported statistically significant improvements in study outcomes. Results: We found 13 randomized controlled trials reporting on 8 online self-management interventions for T2DM. The BCTs used were feedback on performance, providing information on consequences of behavior, barrier identification/problem solving, and self-monitoring of behavior. These BCTs were also linked to positive outcomes for health behavior change, psychological well-being, or clinical parameters. Conclusions: A relatively small number of theory-based online self-management support programs for T2DM have been reported using only a select number of BCTs. The development of future online self-management interventions should be based on the use of theories and BCTs and should be reported accurately. %M 24334230 %R 10.2196/jmir.2800 %U http://www.jmir.org/2013/12/e279/ %U https://doi.org/10.2196/jmir.2800 %U http://www.ncbi.nlm.nih.gov/pubmed/24334230 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 12 %P e266 %T Evaluating Self-Management Behaviors of Diabetic Patients in a Telehealthcare Program: Longitudinal Study Over 18 Months %A Chen,Lichin %A Chuang,Lee-Ming %A Chang,Chia-Hsiun %A Wang,Chiou-Shiang %A Wang,I-Ching %A Chung,Yufang %A Peng,Hui-Yu %A Chen,Hui-Chuen %A Hsu,Yu-Ling %A Lin,Yu-Sheng %A Chen,Huang-Jen %A Chang,Tieng-Chun %A Jiang,Yi-Der %A Lee,Hung-Chang %A Tan,Ching-Ting %A Chang,Hsin-Lu %A Lai,Feipei %+ Graduate Institute of Biomedical Electronics and Bioinformatics, National Taiwan University, No. 1, Sec 4, Roosevelt Road, Taipei, 10617, Taiwan, Taipei, 10617, Taiwan, 886 933846944, d98945012@ntu.edu.tw %K Internet %K diabetes mellitus %K telemedicine %K self-care %K online systems %K personal health record %K patient access to records %D 2013 %7 09.12.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Self-management is an important skill for patients with diabetes, and it involves frequent monitoring of glucose levels and behavior modification. Techniques to enhance the behavior changes of diabetic patients have been developed, such as diabetes self-management education and telehealthcare. Although the patients are engaged in self-management activities, barriers to behavior changes remain and additional work is necessary to address the impact of electronic media and telehealthcare on patient self-care behaviors. Objective: The aims of this study were to (1) explore the behaviors of diabetic patients interacting with online applications, (2) determine the impact of a telehealthcare program among 7 self-care behaviors of the patients, and (3) determine the changes in glycosylated hemoglobin (HbA1c) levels. Methods: A telehealthcare program was conducted to assist the patients with 7 self-care activities. The telehealthcare program lasted for 18 months and included the use of a third-generation mobile telecommunications glucometer, an online diabetes self-management system, and a teleconsultant service. We analyzed the data of 59 patients who participated in the telehealthcare program and 103 who did not. The behavioral assessments and the HbA1c data were collected and statistically analyzed to determine whether the telehealthcare services had an impact on the patients. We divided the 18-month period into 3 6-month intervals and analyzed the parameters of patients assisted by the telehealthcare service at different time points. We also compared the results of those who were assisted by the telehealthcare service with those who were not. Results: There was a significant difference in monitoring blood glucose between the beginning and the end of the patient participation (P=.046) and between the overall period and the end of patient participation (P<.001). Five behaviors were significantly different between the intervention and control patients: being active (P<.001), healthy eating (P<.001), taking medication (P<.001), healthy coping (P=.02), and problem solving (P<.001). Monitoring of blood glucose was significantly different (P=.02) during the 6-12 month stage of patient participation between the intervention and control patients. A significant difference between the beginning and the 6-12 month stage of patient participation was observed for the mean value of HbA1c level (P=.02), and the differences between the overall HbA1c variability and the variability of each 6-month interval was also significant. Conclusions: Telehealthcare had a positive effect on diabetic patients. This study had enhanced blood glucose monitoring, and the patients in the program showed improvements in glycemic control. The self-care behaviors affect patient outcomes, and the changes of behavior require time to show the effects. %M 24323283 %R 10.2196/jmir.2699 %U http://www.jmir.org/2013/12/e266/ %U https://doi.org/10.2196/jmir.2699 %U http://www.ncbi.nlm.nih.gov/pubmed/24323283 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 12 %P e265 %T Young Men’s Views Toward the Barriers and Facilitators of Internet-Based Chlamydia Trachomatis Screening: Qualitative Study %A Lorimer,Karen %A McDaid,Lisa %+ Institute for Applied Health Research, Glasgow Caledonian University, Cowcaddens Road, Glasgow, G4 0BA, United Kingdom, 44 1413318860, karen.lorimer@gcu.ac.uk %K qualitative research %K adolescent male %K socioeconomic status %K chlamydia %K sexually transmitted diseases %K screening %K Internet %D 2013 %7 03.12.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: There is a growing number of Internet-based approaches that offer young people screening for sexually transmitted infections. Objective: This paper explores young men’s views towards the barriers and facilitators of implementing an Internet-based screening approach. The study sought to consider ways in which the proposed intervention would reach and engage men across ages and socioeconomic backgrounds. Methods: This qualitative study included 15 focus groups with 60 heterosexual young men (aged 16-24 years) across central Scotland, drawn across age and socioeconomic backgrounds. Focus groups began by obtaining postcode data to allocate participants to a high/low deprivation category. Focus group discussions involved exploration of men’s knowledge of chlamydia, use of technology, and views toward Internet-based screening. Men were shown sample screening invitation letters, test kits, and existing screening websites to facilitate discussions. Transcripts from audio recordings were analyzed with "Framework Analysis". Results: Men’s Internet and technology use was heterogeneous in terms of individual practices, with greater use among older men (aged 20-24 years) than teenagers and some deprivation-related differences in use. We detail three themes related to barriers to successful implementation: acceptability, confidentiality and privacy concerns, and language, style, and content. These themes identify ways Internet-based screening approaches may fail to engage some men, such as by raising anxiety and failing to convey confidentiality. Men wanted screening websites to frame screening as a serious issue, rather than using humorous images and text. Participants were encouraged to reach a consensus within their groups on their broad design and style preferences for a screening website; this led to a set of common preferences that they believed were likely to engage men across age and deprivation groups and lead to greater screening uptake. Conclusions: The Internet provides opportunities for re-evaluating how we deliver sexual health promotion and engage young men in screening. Interventions using such technology should focus on uptake by age and socioeconomic background. Young people should be engaged as coproducers of intervention materials and websites to ensure messages and content are framed appropriately within a fast-changing environment. Doing so may go some way to addressing the overall lower levels of testing and screening among men compared with women. %M 24300158 %R 10.2196/jmir.2628 %U http://www.jmir.org/2013/12/e265/ %U https://doi.org/10.2196/jmir.2628 %U http://www.ncbi.nlm.nih.gov/pubmed/24300158 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 11 %P e257 %T Effectiveness of a Web-Based Physical Activity Intervention in Patients With Knee and/or Hip Osteoarthritis: Randomized Controlled Trial %A Bossen,Daniël %A Veenhof,Cindy %A Van Beek,Karin EC %A Spreeuwenberg,Peter MM %A Dekker,Joost %A De Bakker,Dinny H %+ Netherlands Institute for Health Services Research (NIVEL), Otterstraat 118-124, Utrecht, 3500 BN, Netherlands, 31 302729649, d.bossen@nivel.nl %K physical activity %K osteoarthritis %K Web-based intervention %K randomized controlled trial %D 2013 %7 22.11.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Patients with knee and/or hip osteoarthritis (OA) are less physically active than the general population, while the benefits of physical activity (PA) have been well documented. Based on the behavioral graded activity treatment, we developed a Web-based intervention to improve PA levels in patients with knee and/or hip OA, entitled “Join2move”. The Join2move intervention is a self-paced 9-week PA program in which the patient’s favorite recreational activity is gradually increased in a time-contingent way. Objective: The aim of the study was to investigate whether a fully automated Web-based PA intervention in patients with knee and/or hip OA would result in improved levels of PA, physical function, and self-perceived effect compared with a waiting list control group. Methods: The study design was a two-armed randomized controlled trial which was not blinded. Volunteers were recruited via articles in newspapers and health-related websites. Eligibility criteria for participants were: (1) aged 50-75 years, (2) self-reported knee and/or hip OA, (3) self-reported inactivity (30 minutes of moderate PA, 5 times or less per week), (4) no face-to-face consultation with a health care provider other than general practitioners, for OA in the last 6 months, (5) ability to access the Internet weekly, and (6) no contra-indications to exercise without supervision. Baseline, 3-month, and 12-month follow-up data were collected through online questionnaires. Primary outcomes were PA, physical function, and self-perceived effect. In a subgroup of participants, PA was measured objectively using accelerometers. Secondary outcomes were pain, fatigue, anxiety, depression, symptoms, quality of life, self-efficacy, pain coping, and locus of control. Results: Of the 581 interested respondents, 199 eligible participants were randomly assigned to the intervention (n=100) or waiting list control group (n=99). Response rates of questionnaires were 84.4% (168/199) after 3 months and 75.4% (150/199) after 12 months. In this study, 94.0% (94/100) of participants actually started the program, and 46.0% (46/100) reached the adherence threshold of 6 out of 9 modules completed. At 3 months, participants in the intervention group reported a significantly improved physical function status (difference=6.5 points, 95% CI 1.8-11.2) and a positive self-perceived effect (OR 10.7, 95% CI 4.3-26.4) compared with the control group. No effect was found for self-reported PA. After 12 months, the intervention group showed higher levels of subjective (difference=21.2 points, 95% CI 3.6-38.9) and objective PA (difference=24 minutes, 95% CI 0.5-46.8) compared with the control group. After 12 months, no effect was found for physical function (difference=5 points, 95% CI −1.0 to 11.0) and self-perceived effect (OR 1.2, 95% CI 0.6-2.4). For several secondary endpoints, the intervention group demonstrated improvements in favor of the intervention group. Conclusions: Join2move resulted in changes in the desired direction for several primary and secondary outcomes. Given the benefits and its self-help format, Join2move could be a component in the effort to enhance PA in sedentary patients with knee and/or hip OA. Trial Registration: The Netherlands National Trial Register: NTR2483; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2483 (Archived by WebCite at http://www.webcitation.org/67NqS6Beq). %M 24269911 %R 10.2196/jmir.2662 %U http://www.jmir.org/2013/11/e257/ %U https://doi.org/10.2196/jmir.2662 %U http://www.ncbi.nlm.nih.gov/pubmed/24269911 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 11 %P e252 %T Using Multiple Imputations to Accommodate Time-Outs in Online Interventions %A Shortreed,Susan M %A Bogart,Andy %A McClure,Jennifer B %+ Group Heatlh Research Institute, Biostatistics Unit, 1730 Minor Avenue, Suite 1600, Seattle, WA, 98101, United States, 1 206 287 2088, shortreed.s@ghc.org %K online interventions %K engagement %K time spent online %K multiple imputations %K automatic time-out %K smoking cessation %K utilization %K behavioral research %K Internet %D 2013 %7 21.11.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Accurately estimating the period of time that individuals are exposed to online intervention content is important for understanding program engagement. This can be calculated from time-stamped data reflecting navigation to and from individual webpages. Prolonged periods of inactivity are commonly handled with a time-out feature and assigned a prespecified exposure duration. Unfortunately, this practice can lead to biased results describing program exposure. Objective: The aim of the study was to describe how multiple imputations can be used to better account for the time spent viewing webpages that result in a prolonged period of inactivity or a time-out. Methods: To illustrate this method, we present data on time-outs collected from the Q2 randomized smoking cessation trial. For this analysis, we evaluate the effects on intervention exposure of receiving content written in a prescriptive versus motivational tone. Using multiple imputations, we created five complete datasets in which the time spent viewing webpages that resulted in a time-out were replaced with values estimated with imputation models. We calculated standard errors using Rubin’s formulas to account for the variability due to the imputations. We also illustrate how current methods of accounting for time-outs (excluding timed-out page views or assigning an arbitrary viewing time) can influence conclusions about participant engagement. Results: A total of 63.00% (1175/1865) of participants accessed the online intervention in the Q2 trial. Of the 6592 unique page views, 683 (10.36%, 683/6592) resulted in a time-out. The median time spent viewing webpages that did not result in a time-out was 1.07 minutes. Assuming participants did not spend any time viewing a webpage that resulted in a time-out, no difference between the two message tones was observed (ratio of mean time online: 0.87, 95% CI 0.75-1.02). Assigning 30 minutes of viewing time to all page views that resulted in a time-out concludes that participants who received content in a motivational tone spent less time viewing content (ratio of mean time online: 0.86, 95% CI 0.77-0.98) than those participants who received content in a prescriptive tone. Using multiple imputations to account for time-outs concludes that there is no difference in participant engagement between the two message tones (ratio of mean time online: 0.87; 95% CI 0.75-1.01). Conclusions: The analytic technique chosen can significantly affect conclusions about online intervention engagement. We propose a standardized methodology in which time spent viewing webpages that result in a time-out is treated as missing information and corrected with multiple imputations. Trial Registration: Clinicaltrials.gov NCT00992264; http://clinicaltrials.gov/ct2/show/NCT00992264 (Archived by WebCite at http://www.webcitation.org/6Kw5m8EkP). %M 24263289 %R 10.2196/jmir.2781 %U http://www.jmir.org/2013/11/e252/ %U https://doi.org/10.2196/jmir.2781 %U http://www.ncbi.nlm.nih.gov/pubmed/24263289 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 11 %P e251 %T Directed Use of the Internet for Health Information by Patients With Chronic Kidney Disease: Prospective Cohort Study %A Diamantidis,Clarissa Jonas %A Fink,Wanda %A Yang,Shiming %A Zuckerman,Marni R %A Ginsberg,Jennifer %A Hu,Peter %A Xiao,Yan %A Fink,Jeffrey C %+ Department of Medicine, Division of Nephrology, University of Maryland School of Medicine, 22 S Greene Street, Rm N3W143, Baltimore, MD, , United States, 1 410 328 5720, cdiamantidis@medicine.umaryland.edu %K chronic kidney disease %K health information technology %K patient safety %D 2013 %7 15.11.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Health information technology has become common in the care of patients with chronic diseases; however, there are few such applications employed in kidney disease. Objective: The aim of the study was to evaluate the use of a website providing disease-specific safety information by patients with predialysis chronic kidney disease. Methods: As part of the Safe Kidney Care (SKC) study, an educational website was designed to provide information on safety concerns in chronic kidney disease. Phase I study participants were provided a medical alert accessory with a unique ID number, the Safe Kidney Care website, and an in-person tutorial on the use of the Internet and accessing the SKC website at baseline. Participants were asked to visit the website and enter their unique ID as frequently as they desired over the next 365 days or until their annual follow-up visit, whichever occurred first. Participants’ visits and dwell times on specific safety modules were tracked using embedded webpage PHP scripts linked to a MySQL database, enabling the collection of website usage statistics. Results: Of 108 Phase I participants, 28.7% (31/108) visited the website from 1-6 times during the observation period (median follow-up 365 days). Median access time was 7 minutes per visit (range <1-46) and 13 minutes per person (range <1-123). The three most frequently visited pages were “Renal function calculator”, “Pills to avoid”, and “Foods to avoid”. High school education and frequent Internet use were significantly associated with website entry (P=.02 and P=.03, respectively). Conclusions: Preliminary results show general interest in a Web-based platform designed to improve patient safety in chronic kidney disease. Trial Registration: Clinicaltrials.gov NCT01407367; http://clinicaltrials.gov/show/NCT01407367 (Archived by WebCite at http://www.webcitation.org/6KvxFKA6M). %M 24240617 %R 10.2196/jmir.2848 %U http://www.jmir.org/2013/11/e251/ %U https://doi.org/10.2196/jmir.2848 %U http://www.ncbi.nlm.nih.gov/pubmed/24240617 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 11 %P e249 %T Impact of Seasonality on Recruitment, Retention, Adherence, and Outcomes in a Web-Based Smoking Cessation Intervention: Randomized Controlled Trial %A Graham,Amanda L %A Cha,Sarah %A Cobb,Nathan K %A Fang,Ye %A Niaura,Raymond S %A Mushro,Aaron %+ Schroeder Institute for Tobacco Research and Policy Studies, Legacy, 1724 Massachusetts Avenue, NW, Washington, DC, 20036, United States, 1 202 454 5938, agraham@legacyforhealth.org %K seasonal variation %K smoking cessation %K Internet %K research subject recruitment %D 2013 %7 07.11.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Seasonal variations in smoking and quitting behaviors have been documented, with many smokers seeking cessation assistance around the start of the New Year. What remains unknown is whether smokers who are recruited to cessation treatment trials during the New Year are as motivated to quit, or as likely to enroll in a research trial, adhere to a research protocol, and benefit from a cessation intervention compared to those who are recruited during other times of the year. Objective: The objective of this study was to determine whether smokers recruited during the New Year period differ on measures of motivation and desire to quit, recruitment and retention rates, website utilization rates, and short-term cessation outcomes compared to smokers recruited at other times. Methods: Participants were current smokers who had registered on a free Web-based cessation program (BecomeAnEX.org) and were invited to participate in a clinical trial. The New Year period was defined according to a clear peak and drop in the proportion of visitors who registered on the site, spanning a 15-day period from December 26, 2012 to January 9, 2013. Two other 15-day recruitment periods during summer (July 18, 2012 to August 1, 2012) and fall (November 7, 2012 to November 21, 2012) were selected for comparison. Data were examined from 3 sources: (1) a Web-based clinical trials management system that automated the recruitment and enrollment process, (2) self-report assessments at baseline and 3 months postrandomization, and (3) online tracking software that recorded website utilization during the first 3 months of the trial. Results: Visitors to BecomeAnEX during the New Year period were more likely to register on the site than smokers who visited during summer or fall (conversion rates: 7.4%, 4.6%, 4.9%, respectively; P<.001), but there were no differences in rates of study acceptance, consent, randomization, 3-month follow-up survey completion, or cessation between the 3 periods. New Year participants were older, more educated, more likely to be employed full time, and more likely to have a relationship partner compared with participants recruited at other times during the year, but did not differ on measures of motivation and desire to quit. Conclusions: Smokers visiting a Web-based cessation program during the New Year period were more likely to register for treatment and differ on several demographic variables, but showed similar patterns of treatment engagement, retention, follow-up, and short-term cessation outcomes compared with participants who visited the site during other periods of the year. These results allay scientific concerns about recruiting participants during this time frame and are reassuring for researchers conducting Web-based cessation trials. Trial Registration: ClinicalTrials.gov ID: NCT01544153; http://clinicaltrials.gov/ct2/show/NCT01544153 (Archived by WebCite at http://www.webcitation.org/6KjhmAS9u). %M 24201304 %R 10.2196/jmir.2880 %U http://www.jmir.org/2013/11/e249/ %U https://doi.org/10.2196/jmir.2880 %U http://www.ncbi.nlm.nih.gov/pubmed/24201304 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 11 %P e233 %T Effects of a Web-Based Intervention on Physical Activity and Metabolism in Older Adults: Randomized Controlled Trial %A Wijsman,Carolien A %A Westendorp,Rudi GJ %A Verhagen,Evert ALM %A Catt,Michael %A Slagboom,P Eline %A de Craen,Anton JM %A Broekhuizen,Karen %A van Mechelen,Willem %A van Heemst,Diana %A van der Ouderaa,Frans %A Mooijaart,Simon P %+ Department of Gerontology and Geriatrics, Leiden University Medical Center, PO Box 9600, Leiden, 2300 RC, Netherlands, 31 717370238, c.a.wijsman@lumc.nl %K physical activity %K Internet %K accelerometry %K aging %K metabolism %K self-monitoring %D 2013 %7 06.11.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Lack of physical activity leads to detrimental changes in body composition and metabolism, functional decline, and increased risk of disease in old age. The potential of Web-assisted interventions for increasing physical activity and improving metabolism in older individuals holds great promise but to our knowledge it has not been studied. Objective: The goal of our study was to assess whether a Web-based intervention increases physical activity and improves metabolic health in inactive older adults. Methods: We conducted a 3-month randomized, waitlist-controlled trial in a volunteer sample of 235 inactive adults aged 60-70 years without diabetes. The intervention group received the Internet program Philips DirectLife, which was directed at increasing physical activity using monitoring and feedback by accelerometer and digital coaching. The primary outcome was relative increase in physical activity measured objectively using ankle- and wrist-worn accelerometers. Secondary outcomes of metabolic health included anthropometric measures and parameters of glucose metabolism. Results: In total, 226 participants (97%) completed the study. At the ankle, activity counts increased by 46% (standard error [SE] 7%) in the intervention group, compared to 12% (SE 3%) in the control group (Pdifference<.001). Measured at the wrist, activity counts increased by 11% (SE 3%) in the intervention group and 5% (SE 2%) in the control group (Pdifference=.11). After processing of the data, this corresponded to a daily increase of 11 minutes in moderate-to-vigorous activity in the intervention group versus 0 minutes in the control group (Pdifference=.001). Weight decreased significantly more in the intervention group compared to controls (−1.5 kg vs −0.8 kg respectively, P=.046), as did waist circumference (−2.3 cm vs −1.3 cm respectively, P=.036) and fat mass (−0.6% vs 0.07% respectively, P=.025). Furthermore, insulin and HbA1c levels were significantly more reduced in the intervention group compared to controls (both P<.05). Conclusions: This was the first study to show that in inactive older adults, a 3-month Web-based physical activity intervention was effective in increasing objectively measured daily physical activity and improving metabolic health. Such Web-based interventions provide novel opportunities for large scale prevention of metabolic deregulation in our rapidly aging population. Trial Registration: Dutch Trial Registry: NTR 3045; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3045 (Archived by WebCite at http://www.webcitation.org/6KPw52dCc). %M 24195965 %R 10.2196/jmir.2843 %U http://www.jmir.org/2013/11/e233/ %U https://doi.org/10.2196/jmir.2843 %U http://www.ncbi.nlm.nih.gov/pubmed/24195965 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 11 %P e218 %T Partnership for Health-2, A Web-Based Versus Print Smoking Cessation Intervention for Childhood and Young Adult Cancer Survivors: Randomized Comparative Effectiveness Study %A Emmons,Karen M %A Puleo,Elaine %A Sprunck-Harrild,Kim %A Ford,Jennifer %A Ostroff,Jamie S %A Hodgson,David %A Greenberg,Mark %A Diller,Lisa %A de Moor,Janet %A Tyc,Vida %+ Dana-Farber Cancer Institute, 450 Brookline Ave, LW601, Boston, MA, 02215, United States, 1 617 632 2188, Karen_M_Emmons@dfci.harvard.edu %K cancer survivors %K smoking cessation %K cancer prevention %D 2013 %7 05.11.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Smoking among cancer survivors increases the risk of late effects and second cancers. This article reports on Partnership for Health-2 (PFH-2)—an effort to develop an effective and scalable version of Partnership for Health (PFH), which was a previously tested peer-delivered telephone counseling program that doubled smoking cessation rates among childhood cancer survivors who smoke. Objective: This paper presents results from a randomized controlled trial evaluating the effectiveness of PFH-2 in targeted and tailored Web-based versus print formats. The overall goal was to determine whether the intervention outcomes in these self-guided scalable formats approximate what was found in a more intensive telephone counseling program. Methods: This study was a randomized controlled trial with a 15-month follow-up that included 374 smokers who were survivors of childhood or young adult cancers, recruited from five survivorship clinics. Participants were randomly assigned to a Web-based or print format of the PFH intervention; all had access to free pharmacotherapy. The website was designed to provide new content at each log-on, and a peer counselor moderated a forum/chat feature. The primary outcome was smoking status at 15 months post randomization. Results: In total, 58.3% (77/132) of Web participants logged on at least once (mean visits 3.25). Using multiple imputation methods for missing data, there were similar rates of cessation in the two arms (print: 20/128, 15.6%; Web: 33/201, 6.4%), and no differences in quit attempts or readiness to quit. The quit rates were equivalent to those found in our previous telephone counseling intervention. There were high rates of satisfaction with both of the PFH-2 interventions. Conclusions: The print and Web formats yielded equivalent levels of success to those found with our telephone-delivered intervention and are comparable to other Internet treatment studies. This study provides important options for survivorship programs that may not have resources for interpersonal forms of cessation counseling. Efforts to increase patient use of the interventions may result in higher cessation rates. Trial Registration: Clinicaltrials.gov NCT00588107; http://clinicaltrials.gov/ct2/show/NCT00588107 (Archived by WebCite at http://www.webcitation.org/6K1gJtFEC). %M 24195867 %R 10.2196/jmir.2533 %U http://www.jmir.org/2013/11/e218/ %U https://doi.org/10.2196/jmir.2533 %U http://www.ncbi.nlm.nih.gov/pubmed/24195867 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 11 %P e242 %T MomMoodBooster Web-Based Intervention for Postpartum Depression: Feasibility Trial Results %A Danaher,Brian G %A Milgrom,Jeannette %A Seeley,John R %A Stuart,Scott %A Schembri,Charlene %A Tyler,Milagra S %A Ericksen,Jennifer %A Lester,Whitney %A Gemmill,Alan W %A Kosty,Derek B %A Lewinsohn,Peter %+ Oregon Research Institute, 1776 Millrace Drive, Eugene, OR, 97403, United States, 1 541 484 2123 ext 2201, briand@ori.org %K postpartum depression %K Web-based intervention %D 2013 %7 01.11.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Postpartum depression (PPD)—the most common complication of childbirth—is a significant and prevalent public health problem that severely disrupts family interactions and can result in serious lasting consequences to the health of women and the healthy development of infants. These consequences increase in severity when left untreated; most women with PPD do not obtain help due to a range of logistical and attitudinal barriers. Objective: This pilot study was designed to test the feasibility, acceptability, and potential efficacy of an innovative and interactive guided Web-based intervention for postpartum depression, MomMoodBooster (MMB). Methods: A sample of 53 women who satisfied eligibility criteria (<9 months postpartum, ≥18 years of age, home Internet access and use of personal email, Edinburgh Postnatal Depression Survey score of 12-20 or Patient Health Questionnaire score from 10-19) were invited to use the MMB program. Assessments occurred at screening/pretest, posttest (3 months following enrollment), and at 6 months follow-up. Results: All six sessions of the program were completed by 87% (46/53) of participants. Participants were engaged with the program: visit days (mean 15.2, SD 8.7), number of visits (mean 20.1, SD 12.2), total duration of visits in hours (mean 5.1, SD 1.3), and number of sessions viewed out of six (mean 5.6, SD 1.3) all support high usage. Posttest data were collected from 89% of participants (47/53) and 6-month follow-up data were collected from 87% of participants (46/53). At pretest, 55% (29/53) of participants met PHQ-9 criteria for minor or major depression. At posttest, 90% (26/29) no longer met criteria. Conclusions: These findings support the expanded use and additional testing of the MMB program, including its implementation in a range of clinical and public health settings. Trial Registration: Clinicaltrials.gov NCT00942721; http://clinicaltrials.gov/ct2/show/NCT00942721 (Archived by WebCite at http://www.webcitation.org/6KjYDvYkQ). %M 24191345 %R 10.2196/jmir.2876 %U http://www.jmir.org/2013/11/e242/ %U https://doi.org/10.2196/jmir.2876 %U http://www.ncbi.nlm.nih.gov/pubmed/24191345 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 10 %P e231 %T Rethinking the Dose-Response Relationship Between Usage and Outcome in an Online Intervention for Depression: Randomized Controlled Trial %A Donkin,Liesje %A Hickie,Ian B %A Christensen,Helen %A Naismith,Sharon L %A Neal,Bruce %A Cockayne,Nicole L %A Glozier,Nick %+ Brain & Mind Research Institute, The University of Sydney, 100 Mallet Street, Camperdown, NSW, New South Wales, 2050, Australia, 61 21847886, Liesje.Donkin@sydney.edu.au %K adherence %K Internet %K eHealth %K depression %K patient compliance %D 2013 %7 17.10.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: There is now substantial evidence that Web-based interventions can be effective at changing behavior and successfully treating psychological disorders. However, interest in the impact of usage on intervention outcomes has only been developed recently. To date, persistence with or completion of the intervention has been the most commonly reported metric of use, but this does not adequately describe user behavior online. Analysis of alternative measures of usage and their relationship to outcome may help to understand how much of the intervention users may need to obtain a clinically significant benefit from the program. Objective: The objective of this study was to determine which usage metrics, if any, are associated with outcome in an online depression treatment trial. Methods: Cardiovascular Risk E-couch Depression Outcome (CREDO) is a randomized controlled trial evaluating an unguided Web-based program (E-couch) based on cognitive behavioral therapy and interpersonal therapy for people with depression and cardiovascular disease. In all, 280 participants in the active arm of the trial commenced the program, delivered in 12 modules containing pages of text and activities. Usage data (eg, number of log-ins, modules completed, time spent online, and activities completed) were captured automatically by the program interface. We estimated the association of these and composite metrics with the outcome of a clinically significant improvement in depression score on the Patient Health Questionnaire (PHQ-9) of ≥5 points. Results: In all, 214/280 (76.4%) participants provided outcome data at the end of the 12-week period and were included in the analysis. Of these, 94 (43.9%) participants obtained clinically significant improvement. Participants logged into the program an average of 18.7 times (SD 8.3) with most (62.1%, 133/214) completing all 12 modules. Average time spent online per log-in was 17.3 minutes (SD 10.5). Participants completed an average of 9 of 18 activities available within the program. In a multivariate regression model, only the number of activities completed per log-in was associated with a clinically significant outcome (OR 2.82, 95% CI 1.05-7.59). The final model predicted 7.4% of variance in outcome. Curve estimates indicated that significant logarithmic (P=.009) and linear (P=.002) relationships existed between activities completed per log-in and clinically significant change. Conclusions: Only one objective measure of usage was independently associated with better outcome of a Web-based intervention of known effectiveness. The 4 usage metrics retained in the final step of the regression accounted for little outcome variance. Medium level users appeared to have little additional benefit compared to low users indicating that assumptions of a linear relationship between use and outcome may be too simplistic and further models and variables need to be explored to adequately understand the relationship. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12610000085077; http://www.anzctr.org.au/ACTRN12610000085077.aspx (Archived by WebCite at http://www.webcitation.org/6K9FQtKBn). %M 24135213 %R 10.2196/jmir.2771 %U http://www.jmir.org/2013/10/e231/ %U https://doi.org/10.2196/jmir.2771 %U http://www.ncbi.nlm.nih.gov/pubmed/24135213 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 10 %P e223 %T Adherence to a Web-Based Physical Activity Intervention for Patients With Knee and/or Hip Osteoarthritis: A Mixed Method Study %A Bossen,Daniël %A Buskermolen,Michelle %A Veenhof,Cindy %A de Bakker,Dinny %A Dekker,Joost %+ Netherlands Institute for Health Services Research (NIVEL), Otterstraat 118-124, Utrecht, 1568 BN, Netherlands, 31 302729649, d.bossen@nivel.nl %K adherence %K usage %K Web-based intervention %K mixed method study %D 2013 %7 16.10.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based interventions show promise in promoting a healthy lifestyle, but their effectiveness is hampered by high rates of nonusage. Predictors and reasons for (non)usage are not well known. Identifying which factors are related to usage contributes to the recognition of subgroups who benefit most from Web-based interventions and to the development of new strategies to increase usage. Objective: The aim of this mixed methods study was to explore patient, intervention, and study characteristics that facilitate or impede usage of a Web-based physical activity intervention for patients with knee and/or hip osteoarthritis. Methods: This study is part of a randomized controlled trial that investigated the effects of Web-based physical activity intervention. A total of 199 participants between 50-75 years of age with knee and/or hip osteoarthritis were randomly assigned to a Web-based intervention (n=100) or a waiting list (n=99). This mixed methods study used only data from the individuals allocated to the intervention group. Patients were defined as users if they completed at least 6 out of 9 modules. Logistic regression analyses with a stepwise backward selection procedure were executed to build a multivariate prediction usage model. For the qualitative part, semistructured interviews were conducted. Both inductive and deductive analyses were used to identify patterns in reported reasons for nonusage. Results: Of the 100 participants who received a password and username, 46 completed 6 modules or more. Multivariate regression analyses revealed that higher age (OR 0.94, P=.08) and the presence of a comorbidity (OR 0.33, P=.02) predicted nonusage. The sensitivity analysis indicated that the model was robust to changes in the usage parameter. Results from the interviews showed that a lack of personal guidance, insufficient motivation, presence of physical problems, and low mood were reasons for nonusage. In addition, the absence of human involvement was viewed as a disadvantage and it negatively impacted program usage. Factors that influenced usage positively were trust in the program, its reliability, functionality of the intervention, social support from family or friends, and commitment to the research team. Conclusions: In this mixed methods study, we found patient, intervention, and study factors that were important in the usage and nonusage of a Web-based PA intervention for patients with knee and/or hip osteoarthritis. Although the self-guided components offer several advantages, particularly in relation to costs, reach, and access, we found that older patients and participants with a comorbid condition need a more personal approach. For these groups the integration of Web-based interventions in a health care environment seems to be promising. Trial Registration: The Netherlands National Trial Register (NTR): NTR2483; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2483 (Archived by Webcite at http://www.webcitation.org/67NqS6Beq). %M 24132044 %R 10.2196/jmir.2742 %U http://www.jmir.org/2013/10/e223/ %U https://doi.org/10.2196/jmir.2742 %U http://www.ncbi.nlm.nih.gov/pubmed/24132044 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 10 %P e219 %T Determinants of Successful Weight Loss After Using a Commercial Web-Based Weight Reduction Program for Six Months: Cohort Study %A Postrach,Elisa %A Aspalter,Rosa %A Elbelt,Ulf %A Koller,Michael %A Longin,Rita %A Schulzke,Jörg-Dieter %A Valentini,Luzia %+ The Division of Nutritional Medicine, Department of Gastroenterology and Hepatology, Charité- Universitätsmedizin Berlin, Charitéplatz 1, Berlin, 10117, Germany, 49 30 450 514 113, luzia.valentini@charite.de %K Internet %K weight loss %K overweight %K obesity %K weight reduction program %K efficiency %K program evaluation %K preventive health services %K sex %D 2013 %7 14.10.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: The Internet is widely available and commonly used for health information; therefore, Web-based weight loss programs could provide support to large parts of the population in self-guided weight loss. Previous studies showed that Web-based weight loss interventions can be effective, depending on the quality of the program. The most effective program tools are visual progress charts or tools for the self-monitoring of weight, diet, and exercises. KiloCoach, a commercial program currently available in German-speaking countries, incorporates these features. A previous investigation showed that the program effectively supports users in losing weight. Objective: We investigated weight loss dynamics stratified by weight loss success after 6-month use of KiloCoach. Furthermore, we analyzed possible associations between intensity of program use and weight loss. The results are intended for tailoring user recommendations for weight-loss Internet platforms. Methods: Datasets of KiloCoach users (January 1, 2008 to December 31, 2011) who actively used the platform for 6 months or more were assigned to this retrospective analysis. Users (N=479) were 42.2% men, mean age of 44.0 years (SD 11.7), with a mean body mass index (BMI) of 31.7 kg/m2 (SD 3.2). Based on the weight loss achieved after 6 months, 3 success groups were generated. The unsuccessful group lost <5%, the moderate success group lost 5%-9.9%, and the high success group lost ≥10% of their baseline body weight. At baseline, the unsuccessful (n=261, 54.5%), moderate success (n=133, 27.8%), and high success (n=85, 17.8%) groups were similar in age, weight, BMI, and gender distribution. Results: After 6 months, the unsuccessful group lost 1.2% (SD 2.4), the moderate success group lost 7.4% (SD 1.5), and the high success group lost 14.2% (SD 3.8) of their initial weight (P<.001). Multivariate regression showed that early weight loss (weeks 3-4), the total number of dietary protocols, and the total number of weight entries were independent predictors for 6-month weight reduction (all P<.001) explaining 52% of the variance in weight reduction. Sensitivity analysis by baseline carried forward method confirmed all independent predictors of 6-month weight loss and reduced the model fit by only 11%. The high success group lost weight faster and maintained weight loss more efficiently than the other groups (P<.001). Early weight loss was associated with weight maintenance after 1 year and 2 years (both P<.001). Weight dynamics did not differ between men and women over 6 months when adjusted for baseline and usage parameters (P=.91). The percentage of male long-term users was unusually high (42.2%). Conclusions: Our results suggest that early weight loss and close program adherence (ie, 5 dietary protocols per week and weekly entering of current weight), especially in the early phase of program usage, can improve weight loss outcome. %M 24126250 %R 10.2196/jmir.2648 %U http://www.jmir.org/2013/10/e219/ %U https://doi.org/10.2196/jmir.2648 %U http://www.ncbi.nlm.nih.gov/pubmed/24126250 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 10 %P e227 %T Internet-Based, Culturally Sensitive, Problem-Solving Therapy for Turkish Migrants With Depression: Randomized Controlled Trial %A Ünlü Ince,Burçin %A Cuijpers,Pim %A van 't Hof,Edith %A van Ballegooijen,Wouter %A Christensen,Helen %A Riper,Heleen %+ Department of Clinical Psychology, Faculty of Psychology and Education, VU University Amsterdam, Van der Boechorststraat 1, Amsterdam, 1081 BT, Netherlands, 31 205983688, b.unlu@vu.nl %K depression %K randomized controlled trial %K ethnic groups %K Internet %K psychotherapy %D 2013 %7 11.10.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Turkish migrants living in the Netherlands have a high prevalence of depressive disorders, but experience considerable obstacles to accessing professional help. Providing easily accessible Internet treatments may help to overcome these barriers. Objective: The aim of this study was to evaluate the effectiveness of a culturally sensitive, guided, self-help, problem-solving intervention through the Internet for reducing depressive symptoms in Turkish migrants. Methods: A two-armed randomized controlled trial was conducted. The primary outcome measure was the severity of depressive symptoms; secondary outcome measures were somatic symptoms, anxiety, quality of life, and satisfaction with the treatment. Participants were assessed online at baseline, posttest (6 weeks after baseline), and 4 months after baseline. Posttest results were analyzed on the intention-to-treat sample. Missing values were estimated by means of multiple imputation. Differences in clinical outcome between groups were analyzed with a t test. Cohen’s d was used to determine the between-groups effect size at posttreatment and follow-up. Results: Turkish adults (N=96) with depressive symptoms were randomized to the experimental group (n=49) or to a waitlist control group (n=47). High attrition rates were found among the 96 participants of which 42% (40/96) did not complete the posttest (6 weeks) and 62% (59/96) participants did not complete the follow-up assessment at 4 months. No significant difference between the experimental group and the control group was found for depression at posttest. Recovery occurred significantly more often in the experimental group (33%, 16/49) than in the control group (9%, 4/47) at posttest (P=.02). Because of the high attrition rate, a completers-only analysis was conducted at follow-up. The experimental group showed significant improvement in depression compared to the control group both at posttest (P=.01) and follow-up (P=.01). Conclusions: The results of this study did not show a significant effect on the reduction of depressive symptoms. However, the effect size at posttest was high, which might be an indicator of the possible effectiveness of the intervention when assessed in a larger sample and robust trial. Future research should replicate our study with adequately powered samples. Trial Registration: Dutch Trial Register: NTR2303. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2303 (Archived by WebCite at http://www.webcitation.org/6IOxNgoDu). %M 24121307 %R 10.2196/jmir.2853 %U http://www.jmir.org/2013/10/e227/ %U https://doi.org/10.2196/jmir.2853 %U http://www.ncbi.nlm.nih.gov/pubmed/24121307 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 10 %P e191 %T For Whom Does It Work? Moderators of Outcome on the Effect of a Transdiagnostic Internet-Based Maintenance Treatment After Inpatient Psychotherapy: Randomized Controlled Trial %A Ebert,David Daniel %A Gollwitzer,Mario %A Riper,Heleen %A Cuijpers,Pim %A Baumeister,Harald %A Berking,Matthias %+ Innovation Incubator, Division Health-Training.Online, Leuphana University Lueneburg, Main Building, Ground Floor, Rotenbleicherweg 67, Lüneburg, 21335, Germany, 49 17616781057, Ebert@leuphana.de %K maintenance treatment %K continuation treatment %K Internet-based intervention %K transdiagnostic treatment %K mental disorders/inpatient psychotherapy %K guided self-help %K randomized controlled trial %K relapse prevention %K predictors %K moderators %D 2013 %7 10.10.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Recent studies provide evidence for the effectiveness of Internet-based maintenance treatments for mental disorders. However, it is still unclear which participants might or might not profit from this particular kind of treatment delivery. Objective: The study aimed to identify moderators of treatment outcome in a transdiagnostic Internet-based maintenance treatment (TIMT) offered to patients after inpatient psychotherapy for mental disorders in routine care. Methods: Using data from a randomized controlled trial (N=400) designed to test the effectiveness of TIMT, we performed secondary analyses to identify factors moderating the effects of TIMT (intervention) when compared with those of a treatment-as-usual control condition. TIMT involved an online self-management module, asynchronous patient–therapist communication, a peer support group, and online-based progress monitoring. Participants in the control condition had unstructured access to outpatient psychotherapy, standardized outpatient face-to-face continuation treatment, and psychotropic management. Self-reports of psychopathological symptoms and potential moderators were assessed at the start of inpatient treatment (T1), at discharge from inpatient treatment/start of TIMT (T2), and at 3-month (T3) and 12-month follow-up (T4). Results: Education level, positive outcome expectations, and diagnoses significantly moderated intervention versus control differences regarding changes in outcomes between T2 and T3. Only education level moderated change differences between T2 and T4. The effectiveness of the intervention (vs control) was more pronounced among participants with a low (vs high) education level (T2-T3: B=–0.32, SE 0.16, P=.049; T2-T4: B=–0.42, SE 0.21, P=.049), participants with high (vs low) positive outcome expectations (T2-T3: B=–0.12, SE 0.05, P=.02) and participants with anxiety disorder (vs mood disorder) (T2-T3: B=–0.43, SE 0.21, P=.04). Simple slope analyses revealed that despite some subgroups benefiting less from the intervention than others, all subgroups still benefited significantly. Conclusions: This transdiagnostic Internet-based maintenance treatment might be suitable for a wide range of participants differing in various clinical, motivational, and demographic characteristics. The treatment is especially effective for participants with low education levels. These findings may generalize to other Internet-based maintenance treatments. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 28632626; http://www.controlled-trials.com/isrctn/pf/28632626 (Archived by WebCite at http://www.webcitation.org/6IqZjTLrx). %M 24113764 %R 10.2196/jmir.2511 %U http://www.jmir.org/2013/10/e191/ %U https://doi.org/10.2196/jmir.2511 %U http://www.ncbi.nlm.nih.gov/pubmed/24113764 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 10 %P e216 %T A Web-Based Tool to Support Shared Decision Making for People With a Psychotic Disorder: Randomized Controlled Trial and Process Evaluation %A van der Krieke,Lian %A Emerencia,Ando C %A Boonstra,Nynke %A Wunderink,Lex %A de Jonge,Peter %A Sytema,Sjoerd %+ University of Groningen, University Medical Center, University Center for Psychiatry, Hanzeplein 1, Groningen, 9700 RB, Netherlands, 31 503612108, j.a.j.van.der.krieke@umcg.nl %K psychotic disorders, schizophrenia %K computers %K computer-assisted decision making %K shared decision making %K feasibility studies, randomized clinical trial %D 2013 %7 07.10.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Mental health policy makers encourage the development of electronic decision aids to increase patient participation in medical decision making. Evidence is needed to determine whether these decision aids are helpful in clinical practice and whether they lead to increased patient involvement and better outcomes. Objective: This study reports the outcome of a randomized controlled trial and process evaluation of a Web-based intervention to facilitate shared decision making for people with psychotic disorders. Methods: The study was carried out in a Dutch mental health institution. Patients were recruited from 2 outpatient teams for patients with psychosis (N=250). Patients in the intervention condition (n=124) were provided an account to access a Web-based information and decision tool aimed to support patients in acquiring an overview of their needs and appropriate treatment options provided by their mental health care organization. Patients were given the opportunity to use the Web-based tool either on their own (at their home computer or at a computer of the service) or with the support of an assistant. Patients in the control group received care as usual (n=126). Half of the patients in the sample were patients experiencing a first episode of psychosis; the other half were patients with a chronic psychosis. Primary outcome was patient-perceived involvement in medical decision making, measured with the Combined Outcome Measure for Risk Communication and Treatment Decision-making Effectiveness (COMRADE). Process evaluation consisted of questionnaire-based surveys, open interviews, and researcher observation. Results: In all, 73 patients completed the follow-up measurement and were included in the final analysis (response rate 29.2%). More than one-third (48/124, 38.7%) of the patients who were provided access to the Web-based decision aid used it, and most used its full functionality. No differences were found between the intervention and control conditions on perceived involvement in medical decision making (COMRADE satisfaction with communication: F1,68=0.422, P=.52; COMRADE confidence in decision: F1,67=0.086, P=.77). In addition, results of the process evaluation suggest that the intervention did not optimally fit in with routine practice of the participating teams. Conclusions: The development of electronic decision aids to facilitate shared medical decision making is encouraged and many people with a psychotic disorder can work with them. This holds for both first-episode patients and long-term care patients, although the latter group might need more assistance. However, results of this paper could not support the assumption that the use of electronic decision aids increases patient involvement in medical decision making. This may be because of weak implementation of the study protocol and a low response rate. Trial Registration: Dutch Trial Register (NTR) trial number: 10340; http://www.trialregister.nl/trialreg/admin/rctsearch.asp?Term=10340 (Archived by WebCite at http://www.webcitation.org/6Jj5umAeS). %M 24100091 %R 10.2196/jmir.2851 %U http://www.jmir.org/2013/10/e216/ %U https://doi.org/10.2196/jmir.2851 %U http://www.ncbi.nlm.nih.gov/pubmed/24100091 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 9 %P e213 %T Chinese My Trauma Recovery, A Web-Based Intervention for Traumatized Persons in Two Parallel Samples: Randomized Controlled Trial %A Wang,Zhiyun %A Wang,Jianping %A Maercker,Andreas %+ School of Psychology, Beijing Normal University, Hou Zhulou 1514, No. 19, XinJieKouWai Street, HaiDian District, Beijing, 100875, China, 86 10 5880 9004, wjphh@bnu.edu.cn %K Web-based %K stress disorders %K traumatic %K randomized controlled trial %K self-help %D 2013 %7 30.09.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Guided self-help interventions for PTSD (post-traumatic stress disorder) are a promising tool for the dissemination of contemporary psychological treatment. Objective: This study investigated the efficacy of the Chinese version of the My Trauma Recovery (CMTR) website. Methods: In an urban context, 90 survivors of different trauma types were recruited via Internet advertisements and allocated to a randomized controlled trial (RCT) with a waiting list control condition. In addition, in a rural context, 93 survivors mainly of the 2008 Sichuan earthquake were recruited in-person for a parallel RCT in which the website intervention was conducted in a counseling center and guided by volunteers. Assessment was completed online on a professional Chinese survey website. The primary outcome measure was the Post-traumatic Diagnostic Scale (PDS); secondary outcome measures were Symptom Checklist 90-Depression (SCL-D), Trauma Coping Self-Efficacy Scale (CSE), Post-traumatic Cognitive Changes (PCC), and Social Functioning Impairment (SFI) questionnaires adopted from the My Trauma Recovery website. Results: For the urban sample, findings indicated a significant group×time interaction in post-traumatic symptom severity (F1,88=7.65, P=.007). CMTR reduced post-traumatic symptoms significantly with high effect size after one month of treatment (F1,45=15.13, Cohen’s d=0.81, P<.001) and the reduction was sustained over a 3-month follow-up (F1,45=17.29, Cohen’s d=0.87, P<.001). In the rural sample, the group×time interaction was also significant in post-traumatic symptom severity (F1,91=5.35, P=.02). Post-traumatic symptoms decreased significantly after treatment (F1,48=43.97, Cohen’s d=1.34, P<.001) and during the follow-up period (F1,48=24.22, Cohen’s d=0.99, P<.001). Additional outcome measures (post-traumatic cognitive changes, depression) indicated a range of positive effects, in particular in the urban sample (group×time interactions: F1,88=5.32-8.37, all Ps<.03), contributing to the positive evidence for self-help interventions. Differences in the effects in the two RCTs are exploratorily explained by sociodemographic, motivational, and setting feature differences between the two samples. Conclusions: These findings give support for the short-term efficacy of CMTR in the two Chinese populations and contribute to the literature that self-help Web-based programs can be used to provide mental health help for traumatized persons. Trial Registration: Australia New Zealand Clinical Trials Registry (ANZCTR): ACTRN12611000951954; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000951954 (Archived by WebCite at http://www.webcitation.org/6G7WyNODk). %M 24080137 %R 10.2196/jmir.2690 %U http://www.jmir.org/2013/9/e213/ %U https://doi.org/10.2196/jmir.2690 %U http://www.ncbi.nlm.nih.gov/pubmed/24080137 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 9 %P e209 %T A Field Test of Web-Based Screening for Dry Eye Disease to Enhance Awareness of Eye Problems Among General Internet Users: A Latent Strategy to Promote Health %A Kawashima,Motoko %A Uchino,Miki %A Kawazoe,Takashi %A Kamiyashiki,Masaaki %A Sano,Kokoro %A Tsubota,Kazuo %+ Department of Ophthalomolgy, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 1608582, Japan, 81 3 3353 1211, motoko326@gmail.com %K dry eye %K Schirmer test %K tears %K Internet %K questionnaire %K screening %K Web %K health care %D 2013 %7 27.09.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: A Web-based self-check system including a brief questionnaire would seem to be a suitable tool for rapid disease screening. Objective: The purpose of this preliminary study was to test a Web-based self-screening questionnaire for drawing attention to dry eye disease among general Internet users and identifying those with a higher risk of developing the condition. Methods: A survey website was launched and used to recruit participants from general Internet users. In the first phase, volunteers were asked to complete a Web-based self-screening questionnaire containing 12 questions on dry eye symptoms. The second phase focused on the respondents who reported five or more dry eye symptoms and expressed their intention to seek medical attention. These participants performed the Schirmer test, for evaluating tear production, and completed a paper-based lifestyle questionnaire to provide relevant background data. Results: Of the 1689 visitors to the website, 980 (58.0%) volunteers completed the Web-based self-screening questionnaire. Among these, 355 (36.2%) respondents reported five or more dry eye symptoms. Then, 99 (27.9%) of the symptomatic participants performed the Schirmer test and completed the paper-based lifestyle questionnaire. Out of these, 32 (32.2%) had abnormal tear production (≤5 mm). Conclusions: The proposed Web-based self-screening questionnaire seems to be a promising tool for raising awareness of dry eye disease among general Internet users and identifying those with a higher risk of developing the condition, although further research is needed to validate its effectiveness. %M 24072379 %R 10.2196/jmir.2198 %U http://www.jmir.org/2013/9/e209/ %U https://doi.org/10.2196/jmir.2198 %U http://www.ncbi.nlm.nih.gov/pubmed/24072379 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 9 %P e201 %T Effects of an Individually Tailored Web-Based Chronic Pain Management Program on Pain Severity, Psychological Health, and Functioning %A Nevedal,Dana C %A Wang,Chun %A Oberleitner,Lindsay %A Schwartz,Steven %A Williams,Amy M %+ VA Connecticut Healthcare System, Department of Clinical Health Psychology, 950 Campbell Ave., West Haven, CT, , United States, 1 (203) 932 5711 ext 2910, dcnevedal@gmail.com %K Web-based %K Internet %K chronic pain %K treatment outcome %K pain management %K cognitive behavior therapy %K psychology %D 2013 %7 25.09.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: It is estimated that 30% of adults in the United States experience daily chronic pain. This results in a significant burden on the health care system, in particular primary care, and on the workplace. Chronic pain management with cognitive-behavioral psychological treatment is effective in reducing pain intensity and interference, health-related quality of life, mood, and return to work. However, the population of individuals with chronic pain far exceeds the population of therapists that can provide this care face-to-face. The use of tailored, Web-based interventions for the management of chronic pain could address limitations to access by virtue of its unlimited scalability. Objective: To examine the effects of a tailored Web-based chronic pain management program on subjective pain, activity and work interference, quality of life and health, and stress. Methods: Eligible participants accessed the online pain management program and informed consent via participating employer or health care benefit systems; program participants who completed baseline, 1-, and 6-month assessments were included in the study. Of the 645 participants, the mean age was 56.16 years (SD 12.83), most were female (447/645, 69.3%), and white (505/641, 78.8%). Frequent pain complaints were joint (249/645, 38.6%), back (218/645, 33.8%), and osteoarthritis (174/654, 27.0%). The online pain management program used evidence-based theories of cognitive behavioral intervention, motivational enhancement, and health behavior change to address self-management, coping, medical adherence, social support, comorbidities, and productivity. The program content was individually tailored on several relevant participant variables. Results: Both pain intensity (mean 5.30, SD 2.46), and unpleasantness (mean 5.43, SD 2.52) decreased significantly from baseline to 1-month (mean 4.16, SD 2.69 and mean 4.24, 2.81, respectively) and 6-month (mean 3.78, SD 2.79 and mean 3.78, SD 2.79, respectively) assessments (P<.001). The magnitude of the 6-month effects were large. Trends for decreases in pain interference (36.8% reported moderate or enormous interference) reached significance at 6 months (28.9%, P<.001). The percentage of the sample reporting fair or poor quality of life decreased significantly from 20.6% at baseline to 16.5% at 6 months (P=.006). Conclusions: Results suggest that the tailored online chronic pain management program showed promising effects on pain at 1 and 6 months posttreatment and quality of life at 6 months posttreatment in this naturalistic study. Further research is warranted to determine the significance and magnitude of the intervention’s effects in a randomized controlled trial. %M 24067267 %R 10.2196/jmir.2296 %U http://www.jmir.org/2013/9/e201/ %U https://doi.org/10.2196/jmir.2296 %U http://www.ncbi.nlm.nih.gov/pubmed/24067267 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 9 %P e203 %T Using Chat and Text Technologies to Answer Sexual and Reproductive Health Questions: Planned Parenthood Pilot Study %A Giorgio,Margaret M %A Kantor,Leslie M %A Levine,Deborah S %A Arons,Whitney %+ Department of Nutrition, Public Health, and Food Studies, New York University, 411 Lafayette St, 5th Fl, New York, NY, 10003, United States, 1 617 980 1232, mmg362@nyu.edu %K reproductive health %K sexual health %K public health %K text messaging %K instant messaging %K abortion seekers %K sexually transmitted diseases %K pregnancy %K emergency contraception %K Internet %D 2013 %7 20.09.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Teens and young adults in the United States are in need of sexual and reproductive health information, as evidenced by elevated rates of sexually transmitted infections (STIs), pregnancy, and births among this population. In-person sexuality education programs are helpful, but they are unlikely to rapidly accommodate teens and young adults in a moment of crisis. Evidence suggests that technologies such as instant messaging (IM) and text messaging may be effective ways to provide teens and young adults with sexual and reproductive health information. In September 2010, Planned Parenthood Federation of America launched a text and IM program designed to provide immediate answers to urgent sexual and reproductive health questions from a reliable and confidential source and to link young people to sexual and reproductive health services if needed. Objective: To assess whether this program is successful in reaching the target population, whether user characteristics vary by mode (IM vs text), and whether mode is associated with reaching individuals with high levels of worry or reducing worry postchat. Methods: Data were collected from prechat and postchat surveys for all IM and text message conversations between September 2010 and August 2011. A bivariate analysis was conducted using chi-square tests for differences in the main covariates by mode of conversation. In the multivariable analysis, logistic regression was used to identify factors that were independently associated with prechat levels of worry and changes in worry postchat. Results: A total of 32,589 conversations occurred during the program’s first year. The odds of feeling very worried prechat were highest for IM users (adjusted odds ratio [AOR] 1.43, 95% CI 1.20-1.72), users 17 years and younger (AOR 1.62, 95% CI 1.50-1.74), Latino/Hispanic users (AOR 1.36, 95% CI 1.27-1.46), and black users (AOR 1.40, 95% CI 1.30-1.50). After controlling for the study covariates, there was no significant difference in the odds of feeling better (less worried) postchat between IM and text message users. Feeling better postchat was associated with being younger (≤17 years: AOR 1.42, 95% CI 1.17-1.72; 18-24 years: AOR 1.20, 95% CI 1.02-1.42), being Latino/Hispanic (AOR 1.31, 95% CI 1.10-1.55), reporting that the service was very helpful (AOR 3.47, 95% CI 3.24-4.32), and asking about emergency contraception (AOR 1.35, 95% CI 1.13-1.61). The odds of feeling better were lowest for users with questions about STIs (AOR 0.61, 95% CI 0.47-0.78). Conclusions: The results from the process evaluation suggest that the program was able to provide informational support to vulnerable groups, such as teens and racial minorities, in moments of particular worry. Differences between the IM and text message users reveal that each mode appeals to a different population and that both are necessary to reach a diverse audience. %M 24055754 %R 10.2196/jmir.2619 %U http://www.jmir.org/2013/9/e203/ %U https://doi.org/10.2196/jmir.2619 %U http://www.ncbi.nlm.nih.gov/pubmed/24055754 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 9 %P e206 %T Effects of a Web-Based Tailored Intervention to Reduce Alcohol Consumption in Adults: Randomized Controlled Trial %A Schulz,Daniela N %A Candel,Math JJM %A Kremers,Stef PJ %A Reinwand,Dominique A %A Jander,Astrid %A de Vries,Hein %+ CAPHRI School for Public Health and Primary Care, Department of Health Promotion, Maastricht University, P Debyeplein 1, Maastricht, 6229 HA, Netherlands, 31 43 3882832, dn.schulz@maastrichtuniversity.nl %K alcohol intake %K adults %K eHealth %K computer tailoring %K Web-based intervention %K tailoring methods %K effectiveness %D 2013 %7 17.09.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based tailored interventions provide users with information that is adapted to their individual characteristics and needs. Randomized controlled trials assessing the effects of tailored alcohol self-help programs among adults are scarce. Furthermore, it is a challenge to develop programs that can hold respondents’ attention in online interventions. Objective: To assess whether a 3-session, Web-based tailored intervention is effective in reducing alcohol intake in high-risk adult drinkers and to compare 2 computer-tailoring feedback strategies (alternating vs summative) on behavioral change, dropout, and appreciation of the program. Methods: A single-blind randomized controlled trial was conducted with an experimental group and a control group (N=448) in Germany in 2010-2011. Follow-up took place after 6 months. Drinking behavior, health status, motivational determinants, and demographics were assessed among participants recruited via an online access panel. The experimental group was divided into 2 subgroups. In the alternating condition (n=132), the tailored feedback was split into a series of messages discussing individual topics offered while the respondent was filling out the program. Participants in the summative condition (n=181) received all advice at once after having answered all questions. The actual texts were identical for both conditions. The control group (n=135) only filled in 3 questionnaires. To identify intervention effects, logistic and linear regression analyses were conducted among complete cases (n=197) and after using multiple imputation. Results: Among the complete cases (response rate: 197/448, 44.0%) who did not comply with the German national guideline for low-risk drinking at baseline, 21.1% of respondents in the experimental group complied after 6 months compared with 5.8% in the control group (effect size=0.42; OR 2.65, 95% CI 1.14-6.16, P=.02). The experimental group decreased by 3.9 drinks per week compared to 0.4 drinks per week in the control group, but this did not reach statistical significance (effect size=0.26; beta=−0.12, 95% CI −7.96 to 0.03, P=.05). Intention-to-treat analyses also indicated no statistically significant effect. Separate analyses of the 2 experimental subgroups showed no differences in intervention effects. The dropout rate during the first visit to the intervention website was significantly lower in the alternating condition than in the summative condition (OR 0.23, 95% CI 0.08-0.60, P=.003). Program appreciation was comparable for the 2 experimental groups. Conclusions: Complete case analyses revealed that Web-based tailored feedback can be an effective way to reduce alcohol intake among adults. However, this effect was not confirmed when applying multiple imputations. There was no indication that one of the tailoring strategies was more effective in lowering alcohol intake. Nevertheless, the lower attrition rates we found during the first visit suggest that the version of the intervention with alternating questions and advice may be preferred. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 91623132; http://www.controlled-trials.com/ISRCTN91623132 (Archived by WebCite at http://www.webcitation.org/6J4QdhXeG). %M 24045005 %R 10.2196/jmir.2568 %U http://www.jmir.org/2013/9/e206/ %U https://doi.org/10.2196/jmir.2568 %U http://www.ncbi.nlm.nih.gov/pubmed/24045005 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 9 %P e200 %T An Internet-Based Intervention to Promote Mental Fitness for Mildly Depressed Adults: Randomized Controlled Trial %A Bolier,Linda %A Haverman,Merel %A Kramer,Jeannet %A Westerhof,Gerben J %A Riper,Heleen %A Walburg,Jan A %A Boon,Brigitte %A Bohlmeijer,Ernst %+ Trimbos Institute (Netherlands Institute of Mental Health and Addiction), Department of Public Mental Health, Da Costakade 45, Utrecht, 3521 VS, Netherlands, 31 302971100, lbolier@trimbos.nl %K public health %K prevention %K depression %K well-being %K randomized controlled trial %K Internet %D 2013 %7 16.09.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression is a worldwide problem warranting global solutions to tackle it. Enhancing well-being has benefits in its own right and could be a good strategy for preventing depression. Providing well-being interventions via the Internet may have synergetic effects. Objective: Psyfit (“mental fitness online”) is a fully automated self-help intervention to improve well-being based on positive psychology. This study examines the clinical effects of this intervention. Methods: We conducted a 2-armed randomized controlled trial that compared the effects of access to Psyfit for 2 months (n=143) to a waiting-list control condition (n=141). Mild to moderately depressed adults in the general population seeking self-help were recruited. Primary outcome was well-being measured by Mental Health Continuum-Short Form (MHC-SF) and WHO Well-being Index (WHO-5); secondary outcomes were depressive symptoms, anxiety, vitality, and general health measured by Center for Epidemiological Studies Depression Scale (CES-D), Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A), and Medical Outcomes Study-Short Form (MOS-SF) vitality and general health subscales, respectively. Online measurements were taken at baseline, 2 months, and 6 months after baseline. Results: The dropout rate was 37.8% in the Psyfit group and 22.7% in the control group. At 2-month follow-up, Psyfit tended to be more effective in enhancing well-being (nonsignificantly for MHC-SF: Cohen’s d=0.27, P=.06; significantly for WHO-5: Cohen’s d=0.31, P=.01), compared to the waiting-list control group. For the secondary outcomes, small but significant effects were found for general health (Cohen’s d=0.14, P=.01), vitality (d=0.22, P=.02), anxiety symptoms (Cohen’s d=0.32, P=.001), and depressive symptoms (Cohen’s d=0.36, P=.02). At 6-month follow-up, there were no significant effects on well-being (MHC-SF: Cohen’s d=0.01, P=.90; WHO-5: Cohen’s d=0.26, P=.11), whereas depressive symptoms (Cohen’s d=0.35, P=.02) and anxiety symptoms (Cohen’s d=0.35, P=.001) were still significantly reduced compared to the control group. There was no clear dose–response relationship between adherence and effectiveness, although some significant differences appeared across most outcomes in favor of those completing at least 1 lesson in the intervention. Conclusions: This study shows that an online well-being intervention can effectively enhance well-being (at least in the short-term and for 1 well-being measure) and can help to reduce anxiety and depression symptoms. Further research should focus on increasing adherence and motivation, reaching and serving lower-educated people, and widening the target group to include people with different levels of depressive symptoms. Trial Registration: Netherlands Trial Register (NTR) number: NTR2126; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2126 (archived by WebCite at http://www.webcitation.org/6IIiVrLcO). %M 24041479 %R 10.2196/jmir.2603 %U http://www.jmir.org/2013/9/e200/ %U https://doi.org/10.2196/jmir.2603 %U http://www.ncbi.nlm.nih.gov/pubmed/24041479 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 9 %P e188 %T Long-Term Outcomes of Internet-Based Self-Management Support in Adults With Asthma: Randomized Controlled Trial %A van Gaalen,Johanna L %A Beerthuizen,Thijs %A van der Meer,Victor %A van Reisen,Patricia %A Redelijkheid,Geertje W %A Snoeck-Stroband,Jiska B %A Sont,Jacob K %A , %+ Leiden University Medical Center, Department of Medical Decision Making, Albinusdreef 2, J-10-86, Leiden, 2333 ZA, Netherlands, 31 715264578, j.k.sont@lumc.nl %K asthma %K quality of life %K self-management %K long-term %K eHealth %K Internet %K telemedicine %D 2013 %7 12.09.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Long-term asthma management falls short of the goals set by international guidelines. The Internet is proposed as an attractive medium to support guided self-management in asthma. Recently, in a multicenter, pragmatic randomized controlled parallel trial with a follow-up period of 1 year, patients were allocated Internet-based self-management (IBSM) support (Internet group [IG]) or usual care (UC) alone. IBSM support was automatically terminated after 12 months of follow-up. In this study, IBSM support has been demonstrated to improve asthma-related quality of life, asthma control, lung function, and the number of symptom-free days as compared to UC. IBSM support was based on known key components for effective self-management and included weekly asthma control monitoring and treatment advice, online and group education, and communication (both online and offline) with a respiratory nurse. Objective: The objective of the study was to assess the long-term effects of providing patients 1 year of IBSM support as compared to UC alone. Methods: Two hundred adults with physician-diagnosed asthma (3 or more months of inhaled corticosteroids prescribed in the past year) from 37 general practices and 1 academic outpatient department who previously participated were invited by letter for additional follow-up at 1.5 years after finishing the study. The Asthma Control Questionnaire (ACQ) and the Asthma Quality of Life Questionnaire (AQLQ) were completed by 107 participants (60 UC participants and 47 IG participants). A minimal clinical important difference in both questionnaires is 0.5 on a 7-point scale. Results: At 30 months after baseline, a sustained and significant difference in terms of asthma-related quality of life of 0.29 (95% CI 0.01-0.57) and asthma control of -0.33 (95% CI -0.61 to -0.05) was found in favor of the IBSM group. No such differences were found for inhaled corticosteroid dosage or for lung function, measured as forced expiratory volume in 1 second. Conclusions: Improvements in asthma-related quality of life and asthma control were sustained in patients who received IBSM support for 1 year, even up to 1.5 years after terminating support. Future research should be focused on implementation of IBSM on a wider scale within routine asthma care. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 79864465; http://www.controlled-trials.com/ISRCTN79864465 (Archived by WebCite at http://www.webcitation.org/6J4VHhPk4). %M 24028826 %R 10.2196/jmir.2640 %U http://www.jmir.org/2013/9/e188/ %U https://doi.org/10.2196/jmir.2640 %U http://www.ncbi.nlm.nih.gov/pubmed/24028826 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 9 %P e158 %T Effects of a Web-Based Patient Activation Intervention to Overcome Clinical Inertia on Blood Pressure Control: Cluster Randomized Controlled Trial %A Thiboutot,Jeffrey %A Sciamanna,Christopher N %A Falkner,Bonita %A Kephart,Donna K %A Stuckey,Heather L %A Adelman,Alan M %A Curry,William J %A Lehman,Erik B %+ Pennsylvania State University College of Medicine, MS Hershey Medical Center, Division of General Internal Medicine, H034, 500 University Drive, Hershey, PA, 17033, United States, 1 717 531 4601, cns10@psu.edu %K hypertension %K Internet %K tailored-feedback %K Web-based %D 2013 %7 04.09.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Only approximately half of patients with hypertension have their blood pressure controlled, due in large part to the tendency of primary care providers (PCPs) not to intensify treatment when blood pressure values are elevated. Objective: This study tested the effect of an intervention designed to help patients ask questions at the point of care to encourage PCPs to appropriately intensify blood pressure treatment. Methods: PCPs and their patients with hypertension (N=500) were recruited by letter and randomized into 2 study groups: (1) intervention condition in which patients used a fully automated website each month to receive tailored messages suggesting questions to ask their PCP to improve blood pressure control, and (2) control condition in which a similar tool suggested questions to ask about preventive services (eg, cancer screening). The Web-based tool was designed to be used during each of the 12 study months and before scheduled visits with PCPs. The primary outcome was the percentage of patients in both conditions with controlled blood pressure. Results: Of 500 enrolled patients (intervention condition: n=282; control condition: n=218), 418 (83.6%) completed the 12-month follow-up visit. At baseline, 289 (61.5%) of participants had controlled blood pressure. Most (411/500, 82.2%) participants used the intervention during at least 6 of 12 months and 222 (62.5%) reported asking questions directly from the Web-based tool. There were no group differences in asking about medication intensification and there were no differences in blood pressure control after 12 months between the intervention condition (201/282, 71.3%) and control condition (143/218, 65.6%; P=.27) groups. More intervention condition participants discussed having a creatinine test (92, 52.6% vs 49, 35.5%; P=.02) and urine protein test (81, 44.8% vs 21, 14.6%; P<.001), but no group differences were observed in the rate of testing. The control condition participants reported more frequent discussions about tetanus and pneumonia vaccines and reported more tetanus (30, 13.8% vs 15, 5.3%; P=.02) and pneumonia (25, 11.5% vs 16, 5.7%; P=.02) vaccinations after 12 months. Conclusions: The use of an interactive website designed to overcome clinical inertia for hypertension care did not lead to improvements in blood pressure control. Participant adherence to the intervention was high. The control intervention led to positive changes in the use of preventive services (eg, tetanus immunization) and the intervention condition led to more discussions of hypertension-relevant tests (eg, serum creatinine and urine protein). By providing patients with individually tailored questions to ask during PCP visits, this study demonstrated that participants were likely to discuss the questions with PCPs. These discussions did not, however, lead to improvements in blood pressure control. Trial Registration: ClinicalTrials.gov NCT00377208; http://clinicaltrials.gov/ct2/show/NCT00377208 (Archived by WebCite at http://www.webcitation.org/6IqWiPLon). %M 24004475 %R 10.2196/jmir.2298 %U http://www.jmir.org/2013/9/e158/ %U https://doi.org/10.2196/jmir.2298 %U http://www.ncbi.nlm.nih.gov/pubmed/24004475 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 9 %P e190 %T Exploring Patients' Views of a Cognitive Behavioral Therapy-Based Website for the Self-Management of Irritable Bowel Syndrome Symptoms %A Tonkin-Crine,Sarah %A Bishop,Felicity L %A Ellis,Matthew %A Moss-Morris,Rona %A Everitt,Hazel %+ Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, United Kingdom, 44 2380 240180, sktc1o07@soton.ac.uk %K irritable bowel syndrome %K cognitive behaviour therapy %K Internet %K primary care %K qualitative research %D 2013 %7 03.09.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Cognitive behavioral therapy (CBT) has been shown to have positive effects on the management of irritable bowel syndrome (IBS) symptoms. A factorial pilot randomized placebo-controlled trial (called MIBS) tested the potential effectiveness of a self-management CBT-based website alongside two medications: methylcellulose and mebeverine, and a placebo. The results showed no significant differences in quality of life or symptom severity measures, but enablement and participant’s global assessment of relief was higher in the website groups. Objective: To conduct a qualitative study nested within this trial, in order to explore patients’ views and experiences of using the CBT-based website to facilitate self-management of IBS. Methods: Semistructured interviews were carried out with patients who had used the website with one session of nurse support (n=16) or the website alone (n=15) while participating in the MIBS trial. An inductive thematic analysis was conducted. Results: We identified three types of engagement with the CBT-based website. One group of participants, mostly in the website-only condition, had limited or no engagement with the website. One group engaged with the content and advice on practical lifestyle changes. The final group of participants engaged with the content and advice on psychological aspects related to IBS. Similarities and differences between these three groups are explored. Conclusions: Teaching self-management techniques through a Web intervention was received positively by most of the participants. Concepts linked to cognitive aspects of CBT appeared to be harder for participants to engage with. Participants who received nurse support rated the cognitive aspects more positively, suggesting that some therapy support alongside the website should be considered. However, the Web format was preferred by some who favored anonymity as well as those who appreciated the accessibility and ease of use of this type of management. Suggestions on how to encourage engagement with Web interventions are discussed. %M 24001787 %R 10.2196/jmir.2672 %U http://www.jmir.org/2013/9/e190/ %U https://doi.org/10.2196/jmir.2672 %U http://www.ncbi.nlm.nih.gov/pubmed/24001787 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 9 %P e196 %T A Pre-Post Study on the Appropriateness and Effectiveness of a Web- and Text Messaging-Based Intervention to Reduce Problem Drinking in Emerging Adults %A Haug,Severin %A Schaub,Michael P %A Venzin,Vigeli %A Meyer,Christian %A John,Ulrich %A Gmel,Gerhard %+ Swiss Research Institute for Public Health and Addiction at Zurich University, Konradstrasse 32, Zurich, 8031, Switzerland, 41 44 448 11 74, severin.haug@isgf.uzh.ch %K alcohol intervention %K problem drinking %K young people %K text messaging %K Internet %D 2013 %7 02.09.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Problem drinking, particularly risky single-occasion drinking (RSOD), also called “binge drinking”, is widespread among adolescents and young adults in most Western countries. Few studies have tested the effectiveness of interventions to reduce RSOD in young people with heterogeneous and particularly lower educational background. Objective: To test the appropriateness and initial effectiveness of a combined, individually tailored Web- and text messaging (SMS)–based intervention program to reduce problem drinking in vocational school students. Methods: The fully automated program provided: (1) online feedback about an individual’s drinking pattern compared to the drinking norms of an age- and gender-specific reference group, and (2) recurrent individualized SMS messages over a time period of 3 months. Generalized Estimating Equation (GEE) analyses were used to investigate the longitudinal courses of the following outcomes over the study period of 3 months: RSOD, alcohol-related problems, mean number of standard drinks per week, and maximum number of standard drinks on an occasion. Results: The program was tested in 36 school classes at 7 vocational schools in Switzerland. Regardless of their drinking behavior, 477 vocational school students who owned a mobile phone were invited to participate in the program. Of these, 364 (76.3%) participated in the program. During the intervention period, 23 out of 364 (6.3%) persons unsubscribed from participating in the program. The GEE analyses revealed decreases in the percentage of persons with RSOD from baseline (75.5%, 210/278) to follow-up assessment (67.6%, 188/278, P<.001), in the percentage of persons with alcohol-related problems (20.4%, 57/280 to 14.3%, 40/280, P=.009), and in the mean number of standard drinks per week: 13.4 (SD 15.3) to 11.3 (SD 14.0), P=.002. They also revealed a trend toward a decrease in the mean of the maximum number of drinks consumed on an occasion: 11.3 (SD 10.3) to 10.5 (SD 10.3), P=.08. Conclusions: The results show high acceptance and promising effectiveness of this interventional approach, which could be easily and economically implemented within school classes. %M 23999406 %R 10.2196/jmir.2755 %U http://www.jmir.org/2013/9/e196/ %U https://doi.org/10.2196/jmir.2755 %U http://www.ncbi.nlm.nih.gov/pubmed/23999406 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 8 %P e162 %T Attrition Revisited: Adherence and Retention in a Web-Based Alcohol Trial %A Murray,Elizabeth %A White,Ian R %A Varagunam,Mira %A Godfrey,Christine %A Khadjesari,Zarnie %A McCambridge,Jim %+ e-Health Unit, Research Department of Primary Care and Population Health, University College London, Upper Floor 3, Royal Free Hospital, Rowland Hill Street, London, NW3 2PF, United Kingdom, 44 2077940500 ext 36747, elizabeth.murray@ucl.ac.uk %K Internet %K eHealth %K attrition %K adherence %K retention %K follow-up %D 2013 %7 30.08.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Attrition is a noted feature of eHealth interventions and trials. In 2005, Eysenbach published a landmark paper calling for a “science of attrition,” suggesting that the 2 forms of attrition—nonusage attrition (low adherence to the intervention) and dropout attrition (poor retention to follow-up)—may be related and that this potential relationship deserved further study. Objective: The aim of this paper was to use data from an online alcohol trial to explore Eysenbach’s hypothesis, and to answer 3 research questions: (1) Are adherence and retention related? If so, how, and under which circumstances? (2) Do adherence and retention have similar predictors? Can these predictors adequately explain any relationship between adherence and retention or are there additional, unmeasured predictors impacting on the relationship? (3) If there are additional unmeasured predictors impacting on the relationship, are there data to support Eysenbach’s hypothesis that these are related to overall levels of interest? Methods: Secondary analysis of data from an online trial of an online intervention to reduce alcohol consumption among heavy drinkers. The 2 outcomes were adherence to the intervention measured by number of log-ins, and retention to the trial measured by provision of follow-up data at 3 months (the primary outcome point). Dependent variables were demographic and alcohol-related data collected at baseline. Predictors of adherence and retention were modeled using logistic regression models. Results: Data were available on 7932 participants. Adherence and retention were related in a complex fashion. Participants in the intervention group were more likely than those in the control group to log in more than once (42% vs 28%, P<.001) and less likely than those in the control group to respond at 3 months (40% vs 49%, P<.001). Within each randomized group, participants who logged in more frequently were more likely to respond than those who logged in less frequently. Response rates in the intervention group for those who logged in once, twice, or ≥3 times were 34%, 46%, and 51%, respectively (P<.001); response rates in the control group for those who logged in once, twice, or ≥3 times were 44%, 60%, and 67%, respectively (P<.001). Relationships between baseline characteristics and adherence and retention were also complex. Where demographic characteristics predicted adherence, they tended also to predict retention. However, characteristics related to alcohol consumption and intention or confidence in reducing alcohol consumption tended to have opposite effects on adherence and retention, with factors that predicted improved adherence tending to predict reduced retention. The complexity of these relationships suggested the existence of an unmeasured confounder. Conclusions: In this dataset, adherence and retention were related in a complex fashion. We propose a possible explanatory model for these data. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 31070347; http://www.controlled-trials.com/ISRCTN31070347 (Archived by WebCite at http://www.webcitation.org/6IEmNnlCn). %M 23996958 %R 10.2196/jmir.2336 %U http://www.jmir.org/2013/8/e162/ %U https://doi.org/10.2196/jmir.2336 %U http://www.ncbi.nlm.nih.gov/pubmed/23996958 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 8 %P e163 %T Barriers and Facilitators for the Implementation of an Online Clinical Health Community in Addition to Usual Fertility Care: A Cross-Sectional Study %A Aarts,Johanna WM %A Faber,Marjan J %A den Boogert,Anne G %A Cohlen,Ben J %A van der Linden,Paul JQ %A Kremer,Jan AM %A Nelen,Willianne LDM %+ Radboud University Nijmegen Medical Center, Department of Obstetrics and Gynecology, Radboud University, PO Box 9101, Nijmegen, 6500 HB, Netherlands, 31 243668666, a.aarts@obgyn.umcn.nl %K community networks %K infertility %K Internet %K quality of health care %K patient-centered care %D 2013 %7 25.08.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Online health communities are becoming more popular in health care. Patients and professionals can communicate with one another online, patients can find peer support, and professionals can use it as an additional information channel to their patients. However, the implementation of online health communities into daily practice is challenging. These challenges relate to the fact that patients need to be activated to (1) become a member (ie, subscription) and (2) participate actively within the community before any effect can be expected. Therefore, we aimed at answering 2 research questions: (1) what factors are associated with subscription to an online health community, and (2) which are associated with becoming an active participant within an online health community. Objective: To identify barriers and facilitators as perceived by patients for the implementation of an online health community. Methods: We performed a cross-sectional study. Three Dutch fertility clinics (2 IVF-licensed) offered their patients a secure online clinical health community through which clinicians can provide online information and patients can ask questions to the medical team or share experiences and find support from peers. We randomly selected and invited 278 men and women suffering from infertility and attending 1 of the participating clinics. Participants filled out a questionnaire about their background characteristics and current use of the online community. Possible barriers and facilitators were divided into 2 parts: (1) those for subscription to the community, and (2) those for active participation in the community. We performed 2 multivariate logistic regression analyses to calculate determinants for both subscription and active participation. Results: Subscription appeared to be associated with patients’ background characteristics (eg, gender, treatment phase), intervention-related facilitators (odds ratio [OR] 2.45, 95% CI 1.14-5.27), and patient-related barriers (OR 0.20, 95% CI 0.08-0.54), such as not feeling the need for such an online health community. After subscription, determinants for participation consisted of aspects related to participant’s age (OR 0.86, 95% CI 0.76-0.97), length of infertility (OR 1.48, 05% CI 1.09-2.02), and to intervention-related facilitators (OR 5.79, 95% CI 2.40-13.98), such as its reliable character and possibility to interact with the medical team and peers. Conclusions: Implementing an online health community in addition to usual fertility care should be performed stepwise. At least 2 strategies are needed to increase the proportion of patient subscribers and consequently make them active participants. First, the marketing strategy should contain information tailored to different subgroups of the patient population. Second, for a living online health community, incorporation of interactive elements, as well as frequent news and updates are needed. These results imply that involving patients and their needs into the promotion strategy, community’s design, and implementation are crucial. %M 23996964 %R 10.2196/jmir.2098 %U http://www.jmir.org/2013/8/e163/ %U https://doi.org/10.2196/jmir.2098 %U http://www.ncbi.nlm.nih.gov/pubmed/23996964 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 8 %P e175 %T Use of a Web 2.0 Portal to Improve Education and Communication in Young Patients With Families: Randomized Controlled Trial %A Hanberger,Lena %A Ludvigsson,Johnny %A Nordfeldt,Sam %+ Division of Pediatrics, Department of Clinical and Experimental Medicine, Linköping University, Linköping University Hospital, Linköping, 581 85, Sweden, 46 10 1031378, lena.hanberger@lio.se %K type 1 diabetes %K children %K adolescent %K health information technology %K patient education %K intervention studies %K HbA1c %D 2013 %7 23.08.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Diabetes requires extensive self-care and comprehensive knowledge, making patient education central to diabetes self-management. Web 2.0 systems have great potential to enhance health information and open new ways for patients and practitioners to communicate. Objective: To develop a Web portal designed to facilitate self-management, including diabetes-related information and social networking functions, and to study its use and effects in pediatric patients with diabetes. Methods: A Web 2.0 portal was developed in collaboration with patients, parents, and practitioners. It offered communication with local practitioners, interaction with peers, and access to relevant information and services. Children and adolescents with diabetes in a geographic population of two pediatric clinics in Sweden were randomized to a group receiving passwords for access to the portal or a control group with no access (n=230) for 1 year. All subjects had access during a second study year. Users’ activity was logged by site and page visits. Health-related quality of life (HRQOL), empowerment (DES), and quality of information (QPP) questionnaires were given at baseline and after 1 and 2 study years. Clinical data came from the Swedish pediatric diabetes quality registry SWEDIABKIDS. Results: There was a continuous flow of site visits, decreasing in summer and Christmas periods. In 119/233 families (51%), someone visited the portal the first study year and 169/484 (35%) the second study year. The outcome variables did not differ between intervention and control group. No adverse treatment or self-care effects were identified. A higher proportion of mothers compared to fathers visited once or more the first year (P<.001) and the second year (P<.001). The patients who had someone in the family visiting the portal 5 times or more, had shorter diabetes duration (P=.006), were younger (P=.008), had lower HbA1c after 1 year of access (P=.010), and were more often girls (P<.001). Peer interaction seems to be a valued aspect. Conclusions: The Web 2.0 portal may be useful as a complement to traditional care for this target group. Widespread use of a portal would need integration in routine care and promotion by diabetes team members. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN):92107365; http://www.controlled-trials.com/ISRCTN92107365/ (Archived by WebCite at http://webcitation.org/6IkiIvtSb). %M 23973555 %R 10.2196/jmir.2425 %U http://www.jmir.org/2013/8/e175/ %U https://doi.org/10.2196/jmir.2425 %U http://www.ncbi.nlm.nih.gov/pubmed/23973555 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 8 %P e181 %T Pedometer-Based Internet-Mediated Intervention For Adults With Chronic Low Back Pain: Randomized Controlled Trial %A Krein,Sarah L %A Kadri,Reema %A Hughes,Maria %A Kerr,Eve A %A Piette,John D %A Holleman,Rob %A Kim,Hyungjin Myra %A Richardson,Caroline R %+ VA Ann Arbor Center for Clinical Management Research, VA Ann Arbor Healthcare System, HSR&D (152), PO Box 130170, Ann Arbor, MI, 48113, United States, 1 734 845 3621, skrein@umich.edu %K chronic pain %K Internet %K randomized controlled trial %K exercise therapy %D 2013 %7 22.08.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic pain, especially back pain, is a prevalent condition that is associated with disability, poor health status, anxiety and depression, decreased quality of life, and increased health services use and costs. Current evidence suggests that exercise is an effective strategy for managing chronic pain. However, there are few clinical programs that use generally available tools and a relatively low-cost approach to help patients with chronic back pain initiate and maintain an exercise program. Objective: The objective of the study was to determine whether a pedometer-based, Internet-mediated intervention can reduce chronic back pain-related disability. Methods: A parallel group randomized controlled trial was conducted with 1:1 allocation to the intervention or usual care group. 229 veterans with nonspecific chronic back pain were recruited from one Department of Veterans Affairs (VA) health care system. Participants randomized to the intervention received an uploading pedometer and had access to a website that provided automated walking goals, feedback, motivational messages, and social support through an e-community (n=111). Usual care participants (n=118) also received the uploading pedometer but did not receive the automated feedback or have access to the website. The primary outcome was measured using the Roland Morris Disability Questionnaire (RDQ) at 6 months (secondary) and 12 months (primary) with a difference in mean scores of at least 2 considered clinically meaningful. Both a complete case and all case analysis, using linear mixed effects models, were conducted to assess differences between study groups at both time points. Results: Baseline mean RDQ scores were greater than 9 in both groups. Primary outcome data were provided by approximately 90% of intervention and usual care participants at both 6 and 12 months. At 6 months, average RDQ scores were 7.2 for intervention participants compared to 9.2 for usual care, an adjusted difference of 1.6 (95% CI 0.3-2.8, P=.02) for the complete case analysis and 1.2 (95% CI -0.09 to 2.5, P=.07) for the all case analysis. A post hoc analysis of patients with baseline RDQ scores ≥4 revealed even larger adjusted differences between groups at 6 months but at 12 months the differences were no longer statistically significant. Conclusions: Intervention participants, compared with those receiving usual care, reported a greater decrease in back pain-related disability in the 6 months following study enrollment. Between-group differences were especially prominent for patients reporting greater baseline levels of disability but did not persist over 12 months. Primarily, automated interventions may be an efficient way to assist patients with managing chronic back pain; additional support may be needed to ensure continuing improvements. Trial Registration: ClinicalTrials.gov NCT00694018; http://clinicaltrials.gov/ct2/show/NCT00694018 (Archived by WebCite at http://www.webcitation.org/6IsG4Y90E). %M 23969029 %R 10.2196/jmir.2605 %U http://www.jmir.org/2013/8/e181/ %U https://doi.org/10.2196/jmir.2605 %U http://www.ncbi.nlm.nih.gov/pubmed/23969029 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 8 %P e172 %T Participants, Usage, and Use Patterns of a Web-Based Intervention for the Prevention of Depression Within a Randomized Controlled Trial %A Kelders,Saskia M %A Bohlmeijer,Ernst T %A Van Gemert-Pijnen,Julia EWC %+ Department of Psychology, Health and Technology, University of Twente, PO Box 217, Enschede, 7500 AE, Netherlands, 31 651070689, s.m.kelders@utwente.nl %K Web-based intervention %K depression %K use patterns %K usage %K adherence %K design %K engagement %K attrition %D 2013 %7 20.08.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Although Web-based interventions have been shown to be effective, they are not widely implemented in regular care. Nonadherence (ie, participants not following the intervention protocol) is an issue. By studying the way Web-based interventions are used and whether there are differences between adherers (ie, participants that started all 9 lessons) and nonadherers, more insight can be gained into the process of adherence. Objective: The aims of this study were to (1) describe the characteristics of participants and investigate their relationship with adherence, (2) investigate the utilization of the different features of the intervention and possible differences between adherers and nonadherers, and (3) identify what use patterns emerge and whether there are differences between adherers and nonadherers. Methods: Data were used from 206 participants that used the Web-based intervention Living to the full, a Web-based intervention for the prevention of depression employing both a fully automated and human-supported format. Demographic and baseline characteristics of participants were collected by using an online survey. Log data were collected within the Web-based intervention itself. Both quantitative and qualitative analyses were performed. Results: In all, 118 participants fully adhered to the intervention (ie, started all 9 lessons). Participants with an ethnicity other than Dutch were more often adherers (χ21=5.5, P=.02), and nonadherers used the Internet more hours per day on average (F1,203=3.918, P=.049). A logistic regression showed that being female (OR 2.02, 95% CI 1.01-4.04; P=.046) and having a higher need for cognition (OR 1.02; 95% CI 1.00-1.05; P=.02) increased the odds of adhering to the intervention. Overall, participants logged in an average of 4 times per lesson, but adherers logged in significantly more times per lesson than nonadherers (F1,204=20.710; P<.001). For use patterns, we saw that early nonadherers seemed to use fewer sessions and spend less time than late nonadherers and adherers, and fewer sessions to complete the lesson than adherers. Furthermore, late nonadherers seemed to have a shorter total duration of sessions than adherers. Conclusions: By using log data combined with baseline characteristics of participants, we extracted valuable lessons for redesign of this intervention and the design of Web-based interventions in general. First, although characteristics of respondents can significantly predict adherence, their predictive value is small. Second, it is important to design Web-based interventions to foster adherence and usage of all features in an intervention. Trial Registration: Dutch Trial Register Number: NTR3007; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3007 (Archived by WebCite at http://www.webcitation.org/6ILhI3rd8). %M 23963284 %R 10.2196/jmir.2258 %U http://www.jmir.org/2013/8/e172/ %U https://doi.org/10.2196/jmir.2258 %U http://www.ncbi.nlm.nih.gov/pubmed/23963284 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 8 %P e170 %T Usage of a Generic Web-Based Self-Management Intervention for Breast Cancer Survivors: Substudy Analysis of the BREATH Trial %A van den Berg,Sanne W %A Peters,Esmee J %A Kraaijeveld,J Frank %A Gielissen,Marieke FM %A Prins,Judith B %+ Department of Medical Psychology, Radboud University Nijmegen Medical Centre, PO Box 9101, Nijmegen, 6500 HB, Netherlands, 31 24 36 13608, s.vandenberg@mps.umcn.nl %K usage evaluation %K usage statistics %K intervention adherence %K user groups %K exposure %K Internet %K Web-based intervention %K breast cancer %K log file analysis %K website use %D 2013 %7 19.08.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Generic fully automated Web-based self-management interventions are upcoming, for example, for the growing number of breast cancer survivors. It is hypothesized that the use of these interventions is more individualized and that users apply a large amount of self-tailoring. However, technical usage evaluations of these types of interventions are scarce and practical guidelines are lacking. Objective: To gain insight into meaningful usage parameters to evaluate the use of generic fully automated Web-based interventions by assessing how breast cancer survivors use a generic self-management website. Final aim is to propose practical recommendations for researchers and information and communication technology (ICT) professionals who aim to design and evaluate the use of similar Web-based interventions. Methods: The BREAst cancer ehealTH (BREATH) intervention is a generic unguided fully automated website with stepwise weekly access and a fixed 4-month structure containing 104 intervention ingredients (ie, texts, tasks, tests, videos). By monitoring https-server requests, technical usage statistics were recorded for the intervention group of the randomized controlled trial. Observed usage was analyzed by measures of frequency, duration, and activity. Intervention adherence was defined as continuous usage, or the proportion of participants who started using the intervention and continued to log in during all four phases. By comparing observed to minimal intended usage (frequency and activity), different user groups were defined. Results: Usage statistics for 4 months were collected from 70 breast cancer survivors (mean age 50.9 years). Frequency of logins/person ranged from 0 to 45, total duration/person from 0 to 2324 minutes (38.7 hours), and activity from opening none to all intervention ingredients. 31 participants continued logging in to all four phases resulting in an intervention adherence rate of 44.3% (95% CI 33.2-55.9). Nine nonusers (13%), 30 low users (43%), and 31 high users (44%) were defined. Low and high users differed significantly on frequency (P<.001), total duration (P<.001), session duration (P=.009), and activity (P<.001). High users logged in an average of 21 times, had a mean session duration of 33 minutes, and opened on average 91% of all ingredients. Signing the self-help contract (P<.001), reporting usefulness of ingredients (P=.003), overall satisfaction (P=.028), and user friendliness evaluation (P=.003) were higher in high users. User groups did not differ on age, education, and baseline distress. Conclusions: By reporting the usage of a self-management website for breast cancer survivors, the present study gained first insight into the design of usage evaluations of generic fully automated Web-based interventions. It is recommended to (1) incorporate usage statistics that reflect the amount of self-tailoring applied by users, (2) combine technical usage statistics with self-reported usefulness, and (3) use qualitative measures. Also, (4) a pilot usage evaluation should be a fixed step in the development process of novel Web-based interventions, and (5) it is essential for researchers to gain insight into the rationale of recorded and nonrecorded usage statistics. Trial Registration: Netherlands Trial Register (NTR): 2935; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2935 (Archived by WebCite at http://www.webcitation.org/6IkX1ADEV). %M 23958584 %R 10.2196/jmir.2566 %U http://www.jmir.org/2013/8/e170/ %U https://doi.org/10.2196/jmir.2566 %U http://www.ncbi.nlm.nih.gov/pubmed/23958584 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 8 %P e165 %T Internet-Based Early Intervention to Prevent Posttraumatic Stress Disorder in Injury Patients: Randomized Controlled Trial %A Mouthaan,Joanne %A Sijbrandij,Marit %A de Vries,Giel-Jan %A Reitsma,Johannes B %A van de Schoot,Rens %A Goslings,J Carel %A Luitse,Jan SK %A Bakker,Fred C %A Gersons,Berthold PR %A Olff,Miranda %+ Center for Anxiety Disorders, Research Group Psychotrauma, Department of Psychiatry, Academic Medical Center, Meibergdreef 5, Amsterdam, 3356 BE, Netherlands, 31 208913552, j.mouthaan@amc.uva.nl %K early intervention %K prevention %K Internet %K posttraumatic stress disorder %K cognitive behavior therapy %D 2013 %7 13.08.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Posttraumatic stress disorder (PTSD) develops in 10-20% of injury patients. We developed a novel, self-guided Internet-based intervention (called Trauma TIPS) based on techniques from cognitive behavioral therapy (CBT) to prevent the onset of PTSD symptoms. Objective: To determine whether Trauma TIPS is effective in preventing the onset of PTSD symptoms in injury patients. Methods: Adult, level 1 trauma center patients were randomly assigned to receive the fully automated Trauma TIPS Internet intervention (n=151) or to receive no early intervention (n=149). Trauma TIPS consisted of psychoeducation, in vivo exposure, and stress management techniques. Both groups were free to use care as usual (nonprotocolized talks with hospital staff). PTSD symptom severity was assessed at 1, 3, 6, and 12 months post injury with a clinical interview (Clinician-Administered PTSD Scale) by blinded trained interviewers and self-report instrument (Impact of Event Scale—Revised). Secondary outcomes were acute anxiety and arousal (assessed online), self-reported depressive and anxiety symptoms (Hospital Anxiety and Depression Scale), and mental health care utilization. Intervention usage was documented. Results: The mean number of intervention logins was 1.7, SD 2.5, median 1, interquartile range (IQR) 1-2. Thirty-four patients in the intervention group did not log in (22.5%), 63 (41.7%) logged in once, and 54 (35.8%) logged in multiple times (mean 3.6, SD 3.5, median 3, IQR 2-4). On clinician-assessed and self-reported PTSD symptoms, both the intervention and control group showed a significant decrease over time (P<.001) without significant differences in trend. PTSD at 12 months was diagnosed in 4.7% of controls and 4.4% of intervention group patients. There were no group differences on anxiety or depressive symptoms over time. Post hoc analyses using latent growth mixture modeling showed a significant decrease in PTSD symptoms in a subgroup of patients with severe initial symptoms (n=20) (P<.001). Conclusions: Our results do not support the efficacy of the Trauma TIPS Internet-based early intervention in the prevention of PTSD symptoms for an unselected population of injury patients. Moreover, uptake was relatively low since one-fifth of individuals did not log in to the intervention. Future research should therefore focus on innovative strategies to increase intervention usage, for example, adding gameplay, embedding it in a blended care context, and targeting high-risk individuals who are more likely to benefit from the intervention. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 57754429; http://www.controlled-trials.com/ISRCTN57754429 (Archived by WebCite at http://webcitation.org/6FeJtJJyD). %M 23942480 %R 10.2196/jmir.2460 %U http://www.jmir.org/2013/8/e165/ %U https://doi.org/10.2196/jmir.2460 %U http://www.ncbi.nlm.nih.gov/pubmed/23942480 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 8 %P e159 %T Tablet-Based Strength-Balance Training to Motivate and Improve Adherence to Exercise in Independently Living Older People: A Phase II Preclinical Exploratory Trial %A Silveira,Patrícia %A van de Langenberg,Rolf %A van het Reve,Eva %A Daniel,Florian %A Casati,Fabio %A de Bruin,Eling D %+ University of Trento, Department of Information Engineering and Computer Science, Via Sommarive, 14-Povo, Trento, 38123, Italy, 39 0461 28 20 93, silveira@disi.unitn.it %K motivation %K exercises %K aged %K tablet %K mobility %K delivery of health care %D 2013 %7 12.08.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Reaction time, coordination, and cognition performance typically diminish in older adults, which may lead to gait impairments, falls, and injuries. Regular strength–balance exercises are highly recommended to reduce this problem and to improve health, well-being, and independence in old age. However, many older people face a lack of motivation in addition to other strong barriers to exercise. We developed ActiveLifestyle, an information technology (IT)-based system for active and healthy aging aiming at improving balance and strength. ActiveLifestyle is a training app that runs on a tablet and assists, monitors, and motivates older people to follow personalized training plans autonomously at home. Objective: The objectives were to (1) investigate which IT-mediated motivation strategies increase adherence to physical exercise training plans in older people, (2) assess the impact of ActiveLifestyle on physical activity behavior change, and (3) demonstrate the effectiveness of the ActiveLifestyle training to improve gait speed. Methods: A total of 44 older adults followed personalized, 12-week strength and balance training plans. All participants performed the exercises autonomously at home. Questionnaires were used to assess the technological familiarity and stage of behavior change, as well as the effectiveness of the motivation instruments adopted by ActiveLifestyle. Adherence to the exercise plan was evaluated using performance data collected by the app and through information given by the participants during the study. Pretests and posttests were performed to evaluate gait speed of the participants before and after the study. Results: Participants were 75 years (SD 6), predominantly female (64%), held a trade or professional diploma (54%), and their past profession was in a sitting position (43%). Of the 44 participants who enrolled, 33 (75%) completed the study. The app proved to assist and motivate independently living and healthy older adults to autonomously perform strength–balance exercises (median 6 on a 7-point Likert scale). Social motivation strategies proved more effective than individual strategies to stimulate the participants to comply with the training plan, as well as to change their behavior permanently toward a more physically active lifestyle. The exercises were effective to improve preferred and fast gait speed. Conclusions: ActiveLifestyle assisted and motivated independently living and healthy older people to autonomously perform strength–balance exercises over 12 weeks and had low dropout rates. The social motivation strategies were more effective to stimulate the participants to comply with the training plan and remain on the intervention. The adoption of assistive technology devices for physical intervention tends to motivate and retain older people exercising for longer periods of time. %M 23939401 %R 10.2196/jmir.2579 %U http://www.jmir.org/2013/8/e159/ %U https://doi.org/10.2196/jmir.2579 %U http://www.ncbi.nlm.nih.gov/pubmed/23939401 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 8 %P e151 %T Determinants of Participation in a Web-Based Health Risk Assessment and Consequences for Health Promotion Programs %A Niessen,Maurice AJ %A Laan,Eva L %A Robroek,Suzan JW %A Essink-Bot,Marie-Louise %A Peek,Niels %A Kraaijenhagen,Roderik A %A Van Kalken,Coen K %A Burdorf,Alex %+ NIPED Research Foundation, Courbetstraat 34 H, Amsterdam, 1077 ZV, Netherlands, 31 20 2610444, m.a.j.niessen@niped.nl %K participation %K Internet %K workplace %K health promotion %K health risk assessment %K reach %D 2013 %7 09.08.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: The health risk assessment (HRA) is a type of health promotion program frequently offered at the workplace. Insight into the underlying determinants of participation is needed to evaluate and implement these interventions. Objective: To analyze whether individual characteristics including demographics, health behavior, self-rated health, and work-related factors are associated with participation and nonparticipation in a Web-based HRA. Methods: Determinants of participation and nonparticipation were investigated in a cross-sectional study among individuals employed at five Dutch organizations. Multivariate logistic regression was performed to identify determinants of participation and nonparticipation in the HRA after controlling for organization and all other variables. Results: Of the 8431 employees who were invited, 31.9% (2686/8431) enrolled in the HRA. The online questionnaire was completed by 27.2% (1564/5745) of the nonparticipants. Determinants of participation were some periods of stress at home or work in the preceding year (OR 1.62, 95% CI 1.08-2.42), a decreasing number of weekdays on which at least 30 minutes were spent on moderate to vigorous physical activity (ORdayPA0.84, 95% CI 0.79-0.90), and increasing alcohol consumption. Determinants of nonparticipation were less-than-positive self-rated health (poor/very poor vs very good, OR 0.25, 95% CI 0.08-0.81) and tobacco use (at least weekly vs none, OR 0.65, 95% CI 0.46-0.90). Conclusions: This study showed that with regard to isolated health behaviors (insufficient physical activity, excess alcohol consumption, and stress), those who could benefit most from the HRA were more likely to participate. However, tobacco users and those who rated their overall health as less than positive were less likely to participate. A strong communication strategy, with recruitment messages that take reasons for nonparticipation into account, could prove to be an essential tool for organizations trying to reach employees who are less likely to participate. %M 23933650 %R 10.2196/jmir.2387 %U http://www.jmir.org/2013/8/e151/ %U https://doi.org/10.2196/jmir.2387 %U http://www.ncbi.nlm.nih.gov/pubmed/23933650 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 8 %P e152 %T Validity of Web-Based Self-Reported Weight and Height: Results of the Nutrinet-Santé Study %A Lassale,Camille %A Péneau,Sandrine %A Touvier,Mathilde %A Julia,Chantal %A Galan,Pilar %A Hercberg,Serge %A Kesse-Guyot,Emmanuelle %+ Université Paris 13, Sorbonne Paris Cité, UREN (Nutritional Epidemiology Research Unit), Inserm (U557), Inra (U1125), Cnam, 74 rue Marcel Cachin, Bobigny, 93017, France, 33 148388974, c.lassale@uren.smbh.univ-paris13.fr %K anthropometry %K body weight %K obesity %K self-report %K weights and measures %K validation studies %D 2013 %7 08.08.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: With the growing scientific appeal of e-epidemiology, concerns arise regarding validity and reliability of Web-based self-reported data. Objective: The objectives of the present study were to assess the validity of Web-based self-reported weight, height, and resulting body mass index (BMI) compared with standardized clinical measurements and to evaluate the concordance between Web-based self-reported anthropometrics and face-to-face declarations. Methods: A total of 2513 participants of the NutriNet-Santé study in France completed a Web-based anthropometric questionnaire 3 days before a clinical examination (validation sample) of whom 815 participants also responded to a face-to-face anthropometric interview (concordance sample). Several indicators were computed to compare data: paired t test of the difference, intraclass correlation coefficient (ICC), and Bland–Altman limits of agreement for weight, height, and BMI as continuous variables; and kappa statistics and percent agreement for validity, sensitivity, and specificity of BMI categories (normal, overweight, obese). Results: Compared with clinical data, validity was high with ICC ranging from 0.94 for height to 0.99 for weight. BMI classification was correct in 93% of cases; kappa was 0.89. Of 2513 participants, 23.5% were classified overweight (BMI≥25) with Web-based self-report vs 25.7% with measured data, leading to a sensitivity of 88% and a specificity of 99%. For obesity, 9.1% vs 10.7% were classified obese (BMI≥30), respectively, leading to sensitivity and specificity of 83% and 100%. However, the Web-based self-report exhibited slight underreporting of weight and overreporting of height leading to significant underreporting of BMI (P<.05) for both men and women: –0.32 kg/m2 (SD 0.66) and –0.34 kg/m2 (SD 1.67), respectively. Mean BMI underreporting was –0.16, –0.36, and –0.63 kg/m2 in the normal, overweight, and obese categories, respectively. Almost perfect agreement (ie, concordance) was observed between Web-based and face-to-face report (ICC ranged from 0.96 to 1.00, classification agreement was 98.5%, and kappa 0.97). Conclusions: Web-based self-reported weight and height data from the NutriNet-Santé study can be considered as valid enough to be used when studying associations of nutritional factors with anthropometrics and health outcomes. Although self-reported anthropometrics are inherently prone to biases, the magnitude of such biases can be considered comparable to face-to-face interview. Web-based self-reported data appear to be an accurate and useful tool to assess anthropometric data. %M 23928492 %R 10.2196/jmir.2575 %U http://www.jmir.org/2013/8/e152/ %U https://doi.org/10.2196/jmir.2575 %U http://www.ncbi.nlm.nih.gov/pubmed/23928492 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 8 %P e153 %T The Clinical Effectiveness of Web-Based Cognitive Behavioral Therapy With Face-to-Face Therapist Support for Depressed Primary Care Patients: Randomized Controlled Trial %A Høifødt,Ragnhild Sørensen %A Lillevoll,Kjersti R %A Griffiths,Kathleen M %A Wilsgaard,Tom %A Eisemann,Martin %A Waterloo,Knut %A Kolstrup,Nils %+ Department of Psychology, Faculty of Health Sciences, University of Tromsø, Tromsø, 9037, Norway, 47 776 49230, ragnhild.s.hoifodt@uit.no %K cognitive therapy %K therapy %K computer-assisted %K Internet %K mental health %K depression %K randomized controlled trial %K primary health care %D 2013 %7 05.08.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Most patients with mild to moderate depression receive treatment in primary care, but despite guideline recommendations, structured psychological interventions are infrequently delivered. Research supports the effectiveness of Internet-based treatment for depression; however, few trials have studied the effect of the MoodGYM program plus therapist support. The use of such interventions could improve the delivery of treatment in primary care. Objective: To evaluate the effectiveness and acceptability of a guided Web-based intervention for mild to moderate depression, which could be suitable for implementation in general practice. Methods: Participants (N=106) aged between 18 and 65 years were recruited from primary care and randomly allocated to a treatment condition comprising 6 weeks of therapist-assisted Web-based cognitive behavioral therapy (CBT), or to a 6-week delayed treatment condition. The intervention included the Norwegian version of the MoodGYM program, brief face-to-face support from a psychologist, and reminder emails. The primary outcome measure, depression symptoms, was measured by the Beck Depression Inventory-II (BDI-II). Secondary outcome measures included the Beck Anxiety Inventory (BAI), the Hospital Anxiety and Depression Scale (HADS), the Satisfaction with Life Scale (SWLS), and the EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D). All outcomes were based on self-report and were assessed at baseline, postintervention, and at 6-month follow-up. Results: Postintervention measures were completed by 37 (71%) and 47 (87%) of the 52 participants in the intervention and 54 participants in the delayed treatment group, respectively. Linear mixed-models analyses revealed a significant difference in time trends between the groups for the BDI-II, (P=.002), for HADS depression and anxiety subscales (P<.001 and P=.001, respectively), and for the SWLS (P<.001). No differential group effects were found for the BAI and the EQ-5D. In comparison to the control group, significantly more participants in the intervention group experienced recovery from depression as measured by the BDI-II. Of the 52 participants in the treatment program, 31 (60%) adhered to the program, and overall treatment satisfaction was high. The reduction of depression and anxiety symptoms was largely maintained at 6-month follow-up, and positive gains in life satisfaction were partly maintained. Conclusions: The intervention combining MoodGYM and brief therapist support can be an effective treatment of depression in a sample of primary care patients. The intervention alleviates depressive symptoms and has a significant positive effect on anxiety symptoms and satisfaction with life. Moderate rates of nonadherence and predominately positive evaluations of the treatment also indicate the acceptability of the intervention. The intervention could potentially be used in a stepped-care approach, but remains to be tested in regular primary health care. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12610000257066; http://apps.who.int/trialsearch/trial.aspx?trialid=ACTRN12610000257066 (Archived by WebCite at http://www.webcitation.org/6Ie3YhIZa). %M 23916965 %R 10.2196/jmir.2714 %U http://www.jmir.org/2013/8/e153/ %U https://doi.org/10.2196/jmir.2714 %U http://www.ncbi.nlm.nih.gov/pubmed/23916965 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 8 %P e148 %T Using the Internet to Help With Diet, Weight, and Physical Activity: Results From the Health Information National Trends Survey (HINTS) %A McCully,Scout N %A Don,Brian P %A Updegraff,John A %+ Department of Psychology, Kent State University, 321 Kent Hall, Kent, OH, 44242-0001, United States, 1 330 672 4731, jupdegr1@kent.edu %K physical activity %K weight loss %K dietary habits %K Web-based %K Internet %K utilization %D 2013 %7 01.08.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: The Internet offers a viable platform for cost-effective and wide-reaching health interventions. However, little is known about use of the Internet to help with diet, weight, and physical activity (DWPA) using a nationally representative sample from the United States. Objective: To (1) assess the demographic characteristics of people who use the Internet to help with DWPA, (2) assess whether usage trends changed over time, and (3) investigate the associations between using the Internet for DWPA and health behaviors. Methods: Data on Internet users from the 2007 and 2011 iterations of the Health Information National Trends Survey (HINTS), N=4827 were analyzed using multiple logistic regression to determine the demographic correlates of using the Internet for help with DWPA. Multiple linear regression was used to test the associations between Internet use for DWPA and three health behaviors: fruit intake, vegetable intake, and physical activity. Results: A larger percentage of Internet users used the Internet for DWPA in 2011 (42.83%) than in 2007 (40.43%). In general, Internet users who were younger (OR 0.98, P<.001), more educated (OR 1.40, P<.001), married (OR 1.06, P=.03), of a minority race (non-Hispanic blacks: OR 1.14, P=.02; Hispanics: OR 1.42, P=.01), and who had a higher Body Mass Index (BMI) (OR 1.04, P<.001) were more likely to use the Internet for DWPA. Across survey years, gender was not associated with using the Internet for DWPA (OR 1.03, P=.12), but there was a significant interaction between survey year and gender (OR 1.95, P=.002); in 2007, men were more likely to use the Internet for DWPA, but women were more likely to do so in 2011. Using the Internet for DWPA was associated with more vegetable intake (B=.22, P=.002), more fruit intake (B=.19, P=.001), and more moderate exercise (B=.25, P=.001), although the strength of the associations between using the Internet for DWPA and fruit intake and exercise was weaker in 2011 than in 2007. Conclusions: Contrary to prior research, our population-level study did not show a pronounced gender difference in the use of the Internet for DWPA. Our results support the increasing viability of the Internet as a platform for behavior change intervention, as a growing percentage of Internet users are turning to the Internet for help with DWPA. Additionally, using the Internet for DWPA is associated with better DWPA-related health behaviors. %M 23906945 %R 10.2196/jmir.2612 %U http://www.jmir.org/2013/8/e148/ %U https://doi.org/10.2196/jmir.2612 %U http://www.ncbi.nlm.nih.gov/pubmed/23906945 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 1 %N 2 %P e16 %T Personal Health Technologies in Employee Health Promotion: Usage Activity, Usefulness, and Health-Related Outcomes in a 1-Year Randomized Controlled Trial %A Mattila,Elina %A Orsama,Anna-Leena %A Ahtinen,Aino %A Hopsu,Leila %A Leino,Timo %A Korhonen,Ilkka %+ VTT Technical Research Centre of Finland, PO Box 1300, Tampere, 33101, Finland, 358 207223384, elina.m.mattila@vtt.fi %K health promotion %K intervention %K Internet %K mobile phones %K device %K risk factors %K health technology %D 2013 %7 29.07.2013 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Common risk factors such as obesity, poor nutrition, physical inactivity, stress, and sleep deprivation threaten the wellness and work ability of employees. Personal health technologies may help improve engagement in health promotion programs and maintenance of their effect. Objective: This study investigated personal health technologies in supporting employee health promotion targeting multiple behavioral health risks. We studied the relations of usage activity to demographic and physiological characteristics, health-related outcomes (weight, aerobic fitness, blood pressure and cholesterol), and the perceived usefulness of technologies in wellness management. Methods: We conducted a subgroup analysis of the technology group (114 subjects, 33 males, average age 45 years, average BMI 27.1 kg/m2) of a 3-arm randomized controlled trial (N=352). The trial was organized to study the efficacy of a face-to-face group intervention supported by technologies, including Web services, mobile applications, and personal monitoring devices. Technology usage was investigated based on log files and questionnaires. The associations between sustained usage of Web and mobile technologies and demographic and physiological characteristics were analyzed by comparing the baseline data of sustained and non-sustained users. The associations between sustained usage and changes in health-related outcomes were studied by repeated analysis of variance, using data measured by baseline and end questionnaires, and anthropometric and laboratory measurements. The experienced usability, usefulness, motivation, and barriers to using technologies were investigated by 4 questionnaires and 2 interviews. Results: 111 subjects (97.4%) used technologies at some point of the study, and 33 (29.9%) were classified as sustained users of Web or mobile technologies. Simple technologies, weight scales and pedometer, attracted the most users. The sustained users were slightly older 47 years (95% CI 44 to 49) versus 44 years (95% CI 42 to 45), P=.034 and had poorer aerobic fitness at baseline (mean difference in maximal metabolic equivalent 1.0, 95% Cl 0.39 to 1.39; P=.013) than non-sustained users. They succeeded better in weight management: their weight decreased -1.2 kg (95% CI -2.38 to -0.01) versus +0.6 kg (95% CI -0.095 to 1.27), P=.006; body fat percentage -0.9%-units (95% CI -1.64 to -0.09) versus +0.3%-units (95% CI -0.28 to 0.73), P=.014; and waist circumference -1.4 cm (95% CI -2.60 to -0.20) versus +0.7 cm (95% CI -0.21 to 1.66), P=.01. They also participated in intervention meetings more actively: median 4 meetings (interquartile range; IQR 4–5) versus 4 meetings (IQR 3–4), P=.009. The key factors in usefulness were: simplicity, integration into daily life, and clear feedback on progress. Conclusions: Despite active initial usage, less than 30% of subjects continued using Web or mobile technologies throughout the study. Sustained users achieved better weight-related outcomes than non-sustained users. High non-usage attrition and modest outcomes cast doubt on the potential of technologies to support interventions. %M 25098385 %R 10.2196/mhealth.2557 %U http://mhealth.jmir.org/2013/2/e16/ %U https://doi.org/10.2196/mhealth.2557 %U http://www.ncbi.nlm.nih.gov/pubmed/25098385 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 7 %P e154 %T An Internet-Based Guided Self-Help Intervention for Panic Symptoms: Randomized Controlled Trial %A van Ballegooijen,Wouter %A Riper,Heleen %A Klein,Britt %A Ebert,David Daniel %A Kramer,Jeannet %A Meulenbeek,Peter %A Cuijpers,Pim %+ Department of Clinical Psychology and the EMGO Institute for Health and Care Research, VU University Amsterdam, Van der Boechorststraat 1, Amsterdam, 1081 BT, Netherlands, 31 6 24112991, w.van.ballegooijen@vu.nl %K Internet %K self-help %K panic disorder %K anxiety disorders %K patient adherence %D 2013 %7 29.07.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-based guided self-help is efficacious for panic disorder, but it is not known whether such treatment is effective for milder panic symptoms as well. Objective: To evaluate the effectiveness of Don’t Panic Online, an Internet-based self-help course for mild panic symptoms, which is based on cognitive behavioral principles and includes guidance by email. Methods: A pragmatic randomized controlled trial was conducted. Participants (N=126) were recruited from the general population and randomized to either the intervention group or to a waiting-list control group. Inclusion criteria were a Panic Disorder Severity Scale-Self Report (PDSS-SR) score between 5-15 and no suicide risk. Panic symptom severity was the primary outcome measure; secondary outcome measures were anxiety and depressive symptom severity. Measurements were conducted online and took place at baseline and 12 weeks after baseline (T1). At baseline, diagnoses were obtained by telephone interviews. Results: Analyses of covariance (intention-to-treat) showed no significant differences in panic symptom reduction between groups. Completers-only analyses revealed a moderate effect size in favor of the intervention group (Cohen’s d=0.73, P=.01). Only 27% of the intervention group finished lesson 4 or more (out of 6). Nonresponse at T1 was high for the total sample (42.1%). Diagnostic interviews showed that many participants suffered from comorbid depression and anxiety disorders. Conclusions: The Internet-based guided self-help course appears to be ineffective for individuals with panic symptoms. However, intervention completers did derive clinical benefits from the intervention. Trial Registration: Nederlands Trial Register: NTR1639; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1639 (Archived by WebCite at http://www.webcitation.org/6ITZPozs9). %M 23896222 %R 10.2196/jmir.2362 %U http://www.jmir.org/2013/7/e154/ %U https://doi.org/10.2196/jmir.2362 %U http://www.ncbi.nlm.nih.gov/pubmed/23896222 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 7 %P e137 %T The Effectiveness of a Web-Based Personalized Feedback and Social Norms Alcohol Intervention on United Kingdom University Students: Randomized Controlled Trial %A Bewick,Bridgette M %A West,Robert M %A Barkham,Michael %A Mulhern,Brendan %A Marlow,Robert %A Traviss,Gemma %A Hill,Andrew J %+ Academic Unit of Psychiatry and Behavioural Sciences, Leeds Institute of Health Sciences, School of Medicine, University of Leeds, Charles Thackrah Building, 101 Clarendon Road, Leeds, LS2 9LJ, United Kingdom, 44 1133430809, B.M.Bewick@leeds.ac.uk %K personalized feedback %K Web-based intervention %K student alcohol consumption %D 2013 %7 24.07.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Alcohol consumption in the student population continues to be cause for concern. Building on the established evidence base for traditional brief interventions, interventions using the Internet as a mode of delivery are being developed. Published evidence of replication of initial findings and ongoing development and modification of Web-based personalized feedback interventions for student alcohol use is relatively rare. The current paper reports on the replication of the initial Unitcheck feasibility trial. Objective: To evaluate the effectiveness of Unitcheck, a Web-based intervention that provides instant personalized feedback on alcohol consumption. It was hypothesized that use of Unitcheck would be associated with a reduction in alcohol consumption. Methods: A randomized control trial with two arms (control=assessment only; intervention=fully automated personalized feedback delivered using a Web-based intervention). The intervention was available week 1 through to week 15. Students at a UK university who were completing a university-wide annual student union electronic survey were invited to participate in the current study. Participants (n=1618) were stratified by sex, age group, year of study, self-reported alcohol consumption, then randomly assigned to one of the two arms, and invited to participate in the current trial. Participants were not blind to allocation. In total, n=1478 (n=723 intervention, n=755 control) participants accepted the invitation. Of these, 70% were female, the age ranged from 17-50 years old, and 88% were white/white British. Data were collected electronically via two websites: one for each treatment arm. Participants completed assessments at weeks 1, 16, and 34. Assessment included CAGE, a 7-day retrospective drinking diary, and drinks consumed per drinking occasion. Results: The regression model predicted a monitoring effect, with participants who completed assessments reducing alcohol consumption over the final week. Further reductions were predicted for those allocated to receive the intervention, and additional reductions were predicted as the number of visits to the intervention website increased. Conclusions: Unitcheck can reduce the amount of alcohol consumed, and the reduction can be sustained in the medium term (ie, 19 weeks after intervention was withdrawn). The findings suggest self-monitoring is an active ingredient to Web-based personalized feedback. %M 23883616 %R 10.2196/jmir.2581 %U http://www.jmir.org/2013/7/e137/ %U https://doi.org/10.2196/jmir.2581 %U http://www.ncbi.nlm.nih.gov/pubmed/23883616 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 7 %P e140 %T Efficacy of Standard Versus Enhanced Features in a Web-Based Commercial Weight-Loss Program for Obese Adults, Part 2: Randomized Controlled Trial %A Collins,Clare E %A Morgan,Philip J %A Hutchesson,Melinda J %A Callister,Robin %+ Priority Research Centre in Nutrition and Physical Activity, Nutrition and Dietetics, School of Health Sciences, Faculty of Health, University of Newcastle, Level 2, ATC Building, University Drive, Callaghan, 2308, Australia, 61 2 4921 5646, Clare.Collins@newcastle.edu.au %K intervention studies %K weight loss %K Internet %K randomized controlled trial %K reducing diet %K telemedicine %D 2013 %7 22.07.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Commercial Web-based weight-loss programs are becoming more popular and increasingly refined through the addition of enhanced features, yet few randomized controlled trials (RCTs) have independently and rigorously evaluated the efficacy of these commercial programs or additional features. Objective: To determine whether overweight and obese adults randomized to an online weight-loss program with additional support features (enhanced) experienced a greater reduction in body mass index (BMI) and increased usage of program features after 12 and 24 weeks compared to those randomized to a standard online version (basic). Methods: An assessor-blinded RCT comparing 301 adults (male: n=125, 41.5%; mean age: 41.9 years, SD 10.2; mean BMI: 32.2 kg/m2, SD 3.9) who were recruited and enrolled offline, and randomly allocated to basic or enhanced versions of a commercially available Web-based weight-loss program for 24 weeks. Results: Retention at 24 weeks was greater in the enhanced group versus the basic group (basic 68.5%, enhanced 81.0%; P=.01). In the intention-to-treat analysis of covariance with imputation using last observation carried forward, after 24 weeks both intervention groups had reductions in key outcomes with no difference between groups: BMI (basic mean –1.1 kg/m2, SD 1.5; enhanced mean –1.3 kg/m2, SD 2.0; P=.29), weight (basic mean –3.3 kg, SD 4.7; enhanced mean –4.0 kg, SD 6.2; P=.27), waist circumference (basic mean –3.1 cm, SD 4.6; enhanced mean –4.0 cm, SD 6.2; P=.15), and waist-to-height ratio (basic mean –0.02, SD 0.03; enhanced mean –0.02, SD 0.04, P=.21). The enhanced group logged in more often at both 12 and 24 weeks, respectively (enhanced 12-week mean 34.1, SD 28.1 and 24-week mean 43.1, SD 34.0 vs basic 12-week mean 24.6, SD 25.5 and 24-week mean 31.8, SD 33.9; P=.002). Conclusions: The addition of personalized e-feedback in the enhanced program provided limited additional benefits compared to a standard commercial Web-based weight-loss program. However, it does support greater retention in the program and greater usage, which was related to weight loss. Further research is required to develop and examine Web-based features that may enhance engagement and outcomes and identify optimal usage patterns to enhance weight loss using Web-based programs. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) trial number: ACTRN12610000197033; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=335159 (Archived by WebCite at http://www.webcitation.org/6HoOMGb8j). %M 23876832 %R 10.2196/jmir.2626 %U http://www.jmir.org/2013/7/e140/ %U https://doi.org/10.2196/jmir.2626 %U http://www.ncbi.nlm.nih.gov/pubmed/23876832 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 7 %P e146 %T Online Prevention Aimed at Lifestyle Behaviors: A Systematic Review of Reviews %A Kohl,Leonie FM %A Crutzen,Rik %A de Vries,Nanne K %+ Department of Health Promotion, CAPHRI School for Public Health and Primary Care, Maastricht University, PO Box 616, Maastricht, 6200 MD, Netherlands, 31 43 388 28 28, rik.crutzen@maastrichtuniversity.nl %K eHealth %K telemedicine %K Internet %K prevention %K life style %K health behavior %K RE-AIM %D 2013 %7 16.07.2013 %9 Review %J J Med Internet Res %G English %X Background: Interventions aimed at behavior change are increasingly being delivered over the Internet. Although research on intervention effectiveness has been widely conducted, their true public health impact as indicated by reach, effectiveness, and use is unclear. Objective: The aim of this paper is to (1) review the current literature on online prevention aimed at lifestyle behaviors, and (2) identify research gaps regarding reach, effectiveness, and use. Methods: A systematic search in PubMed revealed relevant literature published between 2005 and 2012 on Internet-delivered behavior change interventions aimed at dietary behaviors, physical activity, alcohol use, smoking, and condom use. Our search yielded 41 eligible reviews, which were analyzed in terms of reach, effectiveness, and use according to the RE-AIM framework. Results: According to health priorities, interventions are largely targeted at weight-related behaviors, such as physical activity and dietary behavior. Evaluations are predominantly effect-focused and overall effects are small, variable, and not sustainable. Determinants of effectiveness are unclear; effectiveness cannot yet be unambiguously attributed to isolated elements. Actual reach of interventions is undiversified, mostly reaching participants who are female, highly educated, white, and living in high-income countries. One of the most substantial problems in online prevention is the low use of the interventions, a phenomenon seen across all behavior domains. Conclusions: More research is needed on effective elements instead of effective interventions, with special attention to long-term effectiveness. The reach and use of interventions need more scientific input to increase the public health impact of Internet-delivered interventions. %M 23859884 %R 10.2196/jmir.2665 %U http://www.jmir.org/2013/7/e146/ %U https://doi.org/10.2196/jmir.2665 %U http://www.ncbi.nlm.nih.gov/pubmed/23859884 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 7 %P e138 %T Supervised Patient Self-Testing of Warfarin Therapy Using an Online System %A Bereznicki,Luke Ryan Elliot %A Jackson,Shane Leigh %A Peterson,Gregory Mark %+ Unit for Medication Outcomes Research and Education, School of Pharmacy, University of Tasmania, Private Bag 26, Hobart, 7001, Australia, 61 036226 ext 2195, Luke.Bereznicki@utas.edu.au %K warfarin %K self-care %K management %K international normalized ratio %K Internet %K communication %D 2013 %7 12.07.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Point-of-care international normalized ratio (INR) monitoring devices simplify warfarin management by allowing selected patients to monitor their own therapy in their homes. Patient self-testing (PST) has been shown to improve the clinical outcomes of warfarin therapy compared to usual care. Objective: To compare management of warfarin therapy using PST combined with online supervision by physicians via a custom system with usual warfarin management, which involved laboratory testing and physician dosing. Methods: Interested patients were recruited via community pharmacies to participate in a warfarin PST training program. Participants were required to have a long-term indication for warfarin, have been taking warfarin for at least 6 months, and have Internet access in their home. The training involved two sessions covering theoretical aspects of warfarin therapy, use of the CoaguChek XS, and the study website. Following training, patients monitored their INR once weekly for up to 3 months. Patients and physicians utilized a secure website to communicate INR values, dosage recommendations, and clinical incidents. Physicians provided a 6-12 month history of INR results for comparison with study results. The percentage of time spent within the therapeutic INR range (TTR) was the primary outcome, with participants acting as their own historical controls. The percentage of INR tests in range and participant satisfaction were secondary outcomes. Results: Sixteen patients completed training requirements. The mean age of participants was 69.8 (SD 10.1) years. TTR improved significantly from 66.4% to 78.4% during PST (P=.01), and the number of tests within the target range also improved significantly (from 66.0% at prior to the study to 75.9% during PST; P=.04). Patients and physicians expressed a high degree of satisfaction with the monitoring strategy and online system. Conclusions: PST supported by an online system for supervision was associated with improved INR control compared to usual care in a small group of elderly patients. Further research is warranted to investigate the clinical outcomes and cost-effectiveness of online systems to support patients monitoring medications and chronic conditions in the home. %M 23853350 %R 10.2196/jmir.2255 %U http://www.jmir.org/2013/7/e138/ %U https://doi.org/10.2196/jmir.2255 %U http://www.ncbi.nlm.nih.gov/pubmed/23853350 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 7 %P e134 %T Overcoming Addictions, a Web-Based Application, and SMART Recovery, an Online and In-Person Mutual Help Group for Problem Drinkers, Part 1: Three-Month Outcomes of a Randomized Controlled Trial %A Hester,Reid K %A Lenberg,Kathryn L %A Campbell,William %A Delaney,Harold D %+ Behavior Therapy Associates, LLC, Research Division, 9426 Indian School Rd NE Ste 1, Albuquerque, NM, 87111, United States, 1 505 345 6100, reidkhester@gmail.com %K addictions %K cognitive-behavioral program %K Web application %K SMART Recovery %K mutual self-help groups %D 2013 %7 11.07.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Overcoming Addictions (OA) is an abstinence-oriented, cognitive behavioral, Web application based on the program of SMART Recovery. SMART Recovery is an organization that has adapted empirically supported treatment strategies for use in a mutual help framework with in-person meetings, online meetings, a forum, and other resources. Objective: To evaluate the effectiveness of OA and SMART Recovery (SR) with problem drinkers who were new to SMART Recovery. Our experimental hypotheses were: (1) all groups will reduce their drinking and alcohol/drug-related consequences at follow-up compared to their baseline levels, (2) the OA condition will reduce their drinking and alcohol/drug-related consequences more than the control group (SR), and (3) the OA+SR condition will reduce their drinking and alcohol/drug-related consequences more than the control group (SR only). Methods: We recruited 189 heavy problem drinkers primarily through SMART Recovery’s website and in-person meetings throughout the United States. We randomly assigned participants to (1) OA alone, (2) OA+attend SMART Recovery (SR) meetings (OA+SR), or (3) attend SR only. Baseline and follow-ups were conducted via GoToMeeting sessions with a Research Assistant (RA) and the study participant. We interviewed significant others to corroborate the participant’s self-report. Primary outcome measures included percent days abstinent (PDA), mean drinks per drinking day (DDD), and alcohol/drug-related consequences. Results: The intent-to-treat analysis of the 3-month outcomes supported the first hypothesis but not the others. Participants in all groups significantly increased their percent days abstinent from 44% to 72% (P<.001), decreased their mean drinks per drinking day from 8.0 to 4.6 (P<.001), and decreased their alcohol/drug-related problems (P<.001). Actual use relationships were found for the OA groups, between SR online meetings and improvement in PDA (r=.261, P=.033). In addition in the OA groups, the number of total sessions of support (including SR & other meetings, counselor visits) was significantly related to PDA (r=.306, P=012) and amount of improvement in alcohol-related problems (r=.305, P=.012). In the SR only group, the number of face-to-face meetings was significantly related to all three dependent variables, and predicted increased PDA (r=.358, P=.003), fewer mean DDD (r=-.250, P=.039), and fewer alcohol-related problems (r=-.244, P=.045), as well as to the amount of improvement in all three of these variables. Six-month follow-ups have been completed, and the results are currently being analyzed. Conclusions: These results support our first experimental hypothesis but not the second or third. All groups significantly increased their PDA and decreased both their mean DDD and their alcohol-related problems, which indicates that both interventions being investigated were equally effective in helping people recover from their problem drinking. Trial Registration: Clinicaltrials.gov NCT01389297; http://clinicaltrials.gov/ct2/show/NCT01389297 (Archived by WebCite at http://www.webcitation.org/6Hh5JC7Yw). %M 23846588 %R 10.2196/jmir.2565 %U http://www.jmir.org/2013/7/e134/ %U https://doi.org/10.2196/jmir.2565 %U http://www.ncbi.nlm.nih.gov/pubmed/23846588 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 7 %P e136 %T Effectiveness of Web-Based Self-Disclosure Peer-to-Peer Support for Weight Loss: Randomized Controlled Trial %A Imanaka,Mie %A Ando,Masahiko %A Kitamura,Tetsuhisa %A Kawamura,Takashi %+ Center for Advanced Medicine and Clinical Research, Hospital, Nagoya University, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan, 81 52 744 1953, mando@med.nagoya-u.ac.jp %K obesity %K weight loss %K health support %K self-disclosure %K email %K randomized controlled trial %D 2013 %7 09.07.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Obesity is one of the most common public health problems in the industrialized world as a cause of noncommunicable diseases. Although primarily used for one-on-one communication, email is available for uninterrupted support for weight loss, but little is known about the effects of dietitian group counseling for weight control via the Internet. Objective: We developed a Web-based self-disclosure health support (WSHS) system for weight loss. This study aims to compare the effect of weight change between those using the WSHS and those using the email health support (EHS). Methods: This study was designed as an open prospective individual randomized controlled trial. Eligible participants were aged 35 to 65 years with a body mass index (BMI) of ≥25.0 in their latest health examination. Participants were randomly assigned to either the WSHS group or the EHS group. Thirteen registered dietitians under the direction of a principal dietitian each instructed 6 to 8 participants from the respective groups. All participants in the WSHS group could receive nutritional advice and calculate their nutritive intake from a photograph of a meal on their computer screen from the Internet sent to them by their dietitian, receive supervision from the registered dietitian, and view fellow participants’ weight changes and lifestyle modifications. In the EHS group, a participant could receive one-on-one nutritional advice and calculate his/her nutritive intake from the photograph of a meal on computer screen sent by email from his/her dietitian, without being able to view fellow participants’ status. The follow-up period was 12 weeks for both groups. The primary outcome measure was change in body weight. The secondary outcome measure included changes in BMI and waist circumference. The intergroup comparison of the changes before and after intervention was evaluated using analysis of covariance. Results: A total of 193 participants were randomly assigned to either the WSHS group (n=97) or the EHS group (n=96). Ten from the WSHS group and 8 from the EHS group dropped out during the study period, and the remaining 87 in the WSHS group and 88 in the EHS group were followed up completely. Weight loss was significantly greater in the WSHS group than in the EHS group (–1.6 kg vs –0.7 kg; adjusted P=.04). However, there were few differences in waist circumference between the 2 groups. (–3.3 cm vs –3.0 cm; adjusted P=.71). Conclusions: Our newly developed WSHS system using forced self-disclosure had better short-term weight loss results. Further study in a longer-term trial is necessary to determine what effects this type of intervention might have on long-term cardiovascular disease. Trial Registration: University Hospital Medical Information Network Clinical Trial Registration (UMIN-CTR): UMIN000009147; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000010719&language=E (Archived by WebCite at http://www.webcitation.org/6HTCkhb1p). %M 23838533 %R 10.2196/jmir.2405 %U http://www.jmir.org/2013/7/e136/ %U https://doi.org/10.2196/jmir.2405 %U http://www.ncbi.nlm.nih.gov/pubmed/23838533 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 7 %P e129 %T An 8-Week Web-Based Weight Loss Challenge With Celebrity Endorsement and Enhanced Social Support: Observational Study %A Hutchesson,Melinda J %A Collins,Clare E %A Morgan,Philip J %A Callister,Robin %+ School of Health Sciences, Faculty of Health, Priority Research Centre in Physical Activity and Nutrition, Hunter Building (HA12), University Drive, Callaghan, 2308, Australia, 61 49215405, melinda.hutchesson@newcastle.edu.au %K weight loss %K Internet %K commercial sector %K user engagement %K retention %D 2013 %7 04.07.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Initial engagement and weight loss within Web-based weight loss programs may predict long-term success. The integration of persuasive Web-based features may boost engagement and therefore weight loss. Objective: To determine whether an 8-week challenge within a commercial Web-based weight loss program influenced weight loss, website use, and attrition in the short term, when compared to the standard program. Methods: De-identified data for participants (mean age 36.7±10.3 years; 86% female) who enrolled in the Biggest Loser Club (BLC) (n=952) and the BLC’s Shannan Ponton Fast Track Challenge (SC) for 8 weeks (n=381) were compared. The BLC program used standard evidence-based website features, with individualized calorie and exercise targets to facilitate a weight loss of 0.5-1 kg per week (–500kcal/day less than estimated energy expenditure). SC used the same website features but in addition promoted greater initial weight loss using a 1200 kcal/day energy intake target and physical activity energy expenditure of 600 kcal/day. SC used persuasive features to facilitate greater user engagement, including offering additional opportunities for social support (eg, webinar meetings with a celebrity personal trainer and social networking) endorsed by a celebrity personal trainer. Self-reported weekly weight records were used to determine weight change after 8 weeks. A primary analysis was undertaken using a generalized linear mixed model (GLMM) with all available weight records for all participants included. Dropout (participants who cancelled their subscription) and nonusage (participants who stopped using the Web-based features) attrition rates at 8 weeks were calculated. The number of participants who accessed each website feature and the total number of days each feature was used were calculated. The difference between attrition rates and website use for the two programs were tested using chi-square and Wilcoxon Rank Sum tests, respectively. Results: Using GLMM, including weight data for all participants, there was significantly greater (P=.03) 8-week weight loss in SC (–5.1 kg [–5.5 to –4.6 kg] or –6.0%) compared to BLC participants (–4.5 kg [–4.8, –4.2] or –5.0%). Dropout rates were low and consistent across groups (BLC: 17 (1.8%) vs SC: 2 (0.5%), P=.08) and 48.7% (456/936) of BLC and 51.2% (184/379) of SC participants accessed the website at 8 weeks, with no difference between programs (P=.48). SC participants accessed the discussion forums, menu plans, exercise plans, and educational materials significantly more than BLC participants (P<.05). Conclusions: Using a short-term challenge with persuasive features, including online social support with endorsement by a celebrity personal trainer, as well as a greater energy balance deficit, within a commercial Web-based weight loss program may facilitate greater initial weight loss and engagement with some program components. The results support the need for a more rigorous and prospective evaluation of Web-based weight loss programs that incorporate additional strategies to enhance initial weight loss and engagement, such as a short-term challenge. %M 23827796 %R 10.2196/jmir.2540 %U http://www.jmir.org/2013/7/e129/ %U https://doi.org/10.2196/jmir.2540 %U http://www.ncbi.nlm.nih.gov/pubmed/23827796 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 6 %P e121 %T A Service-Based Evaluation of a Therapist-Supported Online Cognitive Behavioral Therapy Program for Depression %A Sharry,John %A Davidson,Ruth %A McLoughlin,Orla %A Doherty,Gavin %+ School of Computer Science and Statistics, Trinity College Dublin, O'Reilly Institute, Dublin, D2, Ireland, 353 1 8963858, Gavin.Doherty@tcd.ie %K Internet %K user-computer interface %K depression %K cognitive behavioral therapy %K patient adherence %K online interventions %K guided online program %K online therapist support %K user experience %D 2013 %7 27.06.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Evidence suggests that Internet-delivered cognitive behavioral therapy (CBT) may be as effective as face-to-face delivery for depression, but attrition and engagement rates remain a challenge. Objective: This service-based study aimed to evaluate an online, therapist-supported, CBT-based program for depression. The program was specifically designed to address engagement issues, most notably by integrating online therapist support and communication within the platform. Methods: Participants were 80 adults who were registered university students. Participants used the modular online program over 8 weeks, supported by a therapist. Engagement information was gathered automatically by the online system, and analyzed for all participants. Severity of participants’ self-reported symptoms of depression were assessed preintervention and postintervention using the Beck Depression Inventory-II (BDI-II). Postintervention measures were completed by 53 participants. Results: A high level of engagement was observed compared to a previous study within the same service, along with extensive use of a range of program features. A statistically significant (P<.001) decrease in self-reported depressive symptomatology from preintervention (mean BDI-II 25.47) to postintervention (mean BDI-II 15.53) with a large effect size (d=1.17) was also observed. Conclusions: The results indicate the potential of unintrusive and easily provided online support to enhance engagement with online interventions. The system described in the paper also illustrates how such online support can be tightly integrated with interactive online programs by using a range of design strategies intended to improve the user experience. %M 23807565 %R 10.2196/jmir.2248 %U http://www.jmir.org/2013/6/e121/ %U https://doi.org/10.2196/jmir.2248 %U http://www.ncbi.nlm.nih.gov/pubmed/23807565 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 2 %N 1 %P e21 %T Designing eHealth that Matters via a Multidisciplinary Requirements Development Approach %A Van Velsen,Lex %A Wentzel,Jobke %A Van Gemert-Pijnen,Julia EWC %+ Center for eHealth Research and Disease Management, Department of Psychology, Health, and Technology, University of Twente, PO Box 217, Enschede, 7500AE, Netherlands, 31 534896054, l.vanvelsen@rrd.nl %K health care information systems %K health informatics %K requirements analysis %K software design techniques %K user-centered design %D 2013 %7 24.06.2013 %9 Viewpoint %J JMIR Res Protoc %G English %X Background: Requirements development is a crucial part of eHealth design. It entails all the activities devoted to requirements identification, the communication of requirements to other developers, and their evaluation. Currently, a requirements development approach geared towards the specifics of the eHealth domain is lacking. This is likely to result in a mismatch between the developed technology and end user characteristics, physical surroundings, and the organizational context of use. It also makes it hard to judge the quality of eHealth design, since it makes it difficult to gear evaluations of eHealth to the main goals it is supposed to serve. Objective: In order to facilitate the creation of eHealth that matters, we present a practical, multidisciplinary requirements development approach which is embedded in a holistic design approach for eHealth (the Center for eHealth Research roadmap) that incorporates both human-centered design and business modeling. Methods: Our requirements development approach consists of five phases. In the first, preparatory, phase the project team is composed and the overall goal(s) of the eHealth intervention are decided upon. Second, primary end users and other stakeholders are identified by means of audience segmentation techniques and our stakeholder identification method. Third, the designated context of use is mapped and end users are profiled by means of requirements elicitation methods (eg, interviews, focus groups, or observations). Fourth, stakeholder values and eHealth intervention requirements are distilled from data transcripts, which leads to phase five, in which requirements are communicated to other developers using a requirements notation template we developed specifically for the context of eHealth technologies. Results: The end result of our requirements development approach for eHealth interventions is a design document which includes functional and non-functional requirements, a list of stakeholder values, and end user profiles in the form of personas (fictitious end users, representative of a primary end user group). Conclusions: The requirements development approach presented in this article enables eHealth developers to apply a systematic and multi-disciplinary approach towards the creation of requirements. The cooperation between health, engineering, and social sciences creates a situation in which a mismatch between design, end users, and the organizational context can be avoided. Furthermore, we suggest to evaluate eHealth on a feature-specific level in order to learn exactly why such a technology does or does not live up to its expectations. %M 23796508 %R 10.2196/resprot.2547 %U http://www.researchprotocols.org/2013/1/e21/ %U https://doi.org/10.2196/resprot.2547 %U http://www.ncbi.nlm.nih.gov/pubmed/23796508 %0 Journal Article %@ 14388871 %I JMIR Publications Inc %V 15 %N 6 %P e125 %T Collection and Visualization of Dietary Behavior and Reasons for Eating Using Twitter %A Hingle,Melanie %A Yoon,Donella %A Fowler,Joseph %A Kobourov,Stephen %A Schneider,Michael Lee %A Falk,Daniel %A Burd,Randy %+ University of Arizona, Department of Nutritional Science, University of Arizona, 1177 E. 4th Street, Tucson, AZ, 85721, United States, 1 520 626 1863, rburd@email.arizona.edu %K dietary behavior %K data visualization %K social media %K mobile health %K mHealth %D 2013 %7 24.06.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Increasing an individual’s awareness and understanding of their dietary habits and reasons for eating may help facilitate positive dietary changes. Mobile technologies allow individuals to record diet-related behavior in real time from any location; however, the most popular software applications lack empirical evidence supporting their efficacy as health promotion tools. Objective: The purpose of this study was to test the feasibility and acceptability of a popular social media software application (Twitter) to capture young adults’ dietary behavior and reasons for eating. A secondary aim was to visualize data from Twitter using a novel analytic tool designed to help identify relationships among dietary behaviors, reasons for eating, and contextual factors. Methods: Participants were trained to record all food and beverages consumed over 3 consecutive days (2 weekdays and 1 weekend day) using their mobile device’s native Twitter application. A list of 24 hashtags (#) representing food groups and reasons for eating were provided to participants to guide reporting (eg, #protein, #mood). Participants were encouraged to annotate hashtags with contextual information using photos, text, and links. User experience was assessed through a combination of email reports of technical challenges and a 9-item exit survey. Participant data were captured from the public Twitter stream, and frequency of hashtag occurrence and co-occurrence were determined. Contextual data were further parsed and qualitatively analyzed. A frequency matrix was constructed to identify food and behavior hashtags that co-occurred. These relationships were visualized using GMap algorithmic mapping software. Results: A total of 50 adults completed the study. In all, 773 tweets including 2862 hashtags (1756 foods and 1106 reasons for eating) were reported. Frequently reported food groups were #grains (n=365 tweets), #dairy (n=221), and #protein (n=307). The most frequently cited reasons for eating were #social (activity) (n=122), #taste (n=146), and #convenience (n=173). Participants used a combination of study-provided hash tags and their own hash tags to describe behavior. Most rated Twitter as easy to use for the purpose of reporting diet-related behavior. “Maps” of hash tag occurrences and co-occurrences were developed that suggested time-varying diet and behavior patterns. Conclusions: Twitter combined with an analytical software tool provides a method for capturing real-time food consumption and diet-related behavior. Data visualization may provide a method to identify relationships between dietary and behavioral factors. These findings will inform the design of a study exploring the use of social media and data visualization to identify relationships between food consumption, reasons for engaging in specific food-related behaviors, relevant contextual factors, and weight and health statuses in diverse populations. %M 23796439 %R 10.2196/jmir.2613 %U http://www.jmir.org/2013/6/e125/ %U https://doi.org/10.2196/jmir.2613 %U http://www.ncbi.nlm.nih.gov/pubmed/23796439 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 6 %P e127 %T Cardiovascular Health Effects of Internet-Based Encouragements to Do Daily Workplace Stair-Walks: Randomized Controlled Trial %A Andersen,Lars Louis %A Sundstrup,Emil %A Boysen,Marianne %A Jakobsen,Markus Due %A Mortensen,Ole Steen %A Persson,Roger %+ National Research Centre for the Working Environment, Lersø Parkalle 105, Copenhagen, 2100, Denmark, 45 39165300, lla@nrcwe.dk %K physical activity %K Internet technology %K sedentary %K fitness %K vigorous activity %K intervention %K randomized controlled trial %K stair-walk %K blood pressure %K body mass index %D 2013 %7 21.06.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Although the hazardous health effects of a sedentary lifestyle are well known, many adults struggle with regular physical activity. Simple and efficient encouragements for increased physical activity are needed. Objective: To determine the effect on cardiovascular health of email-based encouragements to do daily stair-walks at work together with colleagues among adults in sedentary occupations. Methods: A single-blind randomized controlled trial was performed at a large administrative company in Copenhagen, Denmark. Participants were 160 office workers (125 women, 35 men; mean age 42 years, SD 10; sitting 89.5% of work time). At baseline, aerobic fitness was 37 mL/min/kg (SD 9), mean blood pressure was 118/79 mmHg (SD 14/9), and mean body mass index (BMI) was 23 kg/m2 (SD 4). Participants were randomly assigned (2:1 ratio) to an email group receiving weekly email-based encouragements to walk the stairs for 10 minutes a day or to a control group receiving weekly reminders to continue their usual physical activities. The primary outcome was the change from baseline to 10-week follow-up in aerobic fitness determined from a maximal cycle test. The examiner was blinded to group allocation. Results: Adherence to the email encouragements was fairly high with 82.7% of the participants performing at least 3 sessions of 10-minute stair-walks per week (mean 3.3, SD 1.3). Mean heart rate reached 167 beats/min (SD 10) during stair-walks. In the intention-to-treat analysis, aerobic fitness increased 1.45 mL/min/kg (95% CI 0.64-2.27) at 10-week follow-up in the email group compared with the control group. In participants with low aerobic fitness at baseline (n=56), aerobic fitness increased 1.89 mL/min/kg (95% CI 0.53-3.24), and systolic and diastolic blood pressure decreased 4.81 mmHg (95% CI 0.47-9.16) and 2.67 mmHg (95% CI 0.01-5.32), respectively, in the email group compared with the control group. Body weight decreased in the email group of those with low aerobic fitness compared with the control group, but this was not statistically significant. Conclusions: Simple and inexpensive email-based encouragements to do daily stair-walks together with colleagues at work improves cardiovascular health among adults in sedentary occupations. There exists an enormous potential to prevent the hazardous health effects of a sedentary lifestyle through the use of email-based encouragements to do short bouts of physical activity at the workplace. Trial Registration: Clinicaltrials.gov NCT01293253; http://clinicaltrials.gov/ct2/show/NCT01293253 (Archived by WebCite at http://www.webcitation.org/6HWG2jw68). %M 23793032 %R 10.2196/jmir.2340 %U http://www.jmir.org/2013/6/e127/ %U https://doi.org/10.2196/jmir.2340 %U http://www.ncbi.nlm.nih.gov/pubmed/23793032 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 6 %P e126 %T Patients’ Experiences of Helpfulness in Guided Internet-Based Treatment for Depression: Qualitative Study of Integrated Therapeutic Dimensions %A Lillevoll,Kjersti R %A Wilhelmsen,Maja %A Kolstrup,Nils %A Høifødt,Ragnhild Sørensen %A Waterloo,Knut %A Eisemann,Martin %A Risør,Mette Bech %+ Department of Psychology, Faculty of Health Sciences, University of Tromsø, Tromsø, 9037, Norway, 47 77646774, kjersti.lillevoll@uit.no %K Internet-based cognitive behavioral therapy %K ICBT %K guided self-help %K depression %K qualitative %D 2013 %7 20.06.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Quantitative research on Internet-based cognitive behavioral therapy (ICBT) has collected substantial evidence for the effectiveness of this treatment approach on health outcomes. Less is known about how patients find ICBT to be generally meaningful and helpful for treating depression. Objective: To explore patients’ experiences of being in ICBT treatment with a focus on the treatment dimensions that they considered helpful. Methods: Choosing a phenomenological-hermeneutical approach, 14 patients were interviewed with semistructured qualitative interviews to elicit their understanding of using ICBT. The patients took part in a clinical trial using ICBT with MoodGYM, which also featured brief consultations with a clinical psychologist. The interviews were transcribed and analyzed according to the chosen methodology and organized into significant themes. Results: The phenomenological-hermeneutical analysis identified 5 themes relating overall to the meaning of this mode of treatment in terms of helpfulness. Two related to treatment in general: (1) taking action to address one’s problems and (2) the value of talking to a professional. The next two themes specifically addressed guided self-help using the MoodGYM program: (3) acquiring relevant knowledge, and (4) restructuring the new knowledge acquired through ICBT. A fifth theme concerned (5) actual changes in patients’ perceptions and interactions, related to either the self-help material or the face-to-face consultations with the therapist. Conclusions: Three important dimensions were made explicit: the active engagement of the patient, the guidance of the therapist, and the content of the treatment program. The findings pointed to (1) the role of MoodGYM as a source of new knowledge providing patients with a structured approach to work with their depression, (2) the patient’s role as the primary agent of change through adapting relevant knowledge from MoodGYM to their situation, and (3) the dialogue with the therapist as a trusting relationship in which to share thoughts and feelings, receive feedback and advice, and to assist the patient in making use of the MoodGYM content. %M 23786763 %R 10.2196/jmir.2531 %U http://www.jmir.org/2013/6/e126/ %U https://doi.org/10.2196/jmir.2531 %U http://www.ncbi.nlm.nih.gov/pubmed/23786763 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 6 %P e111 %T Comparison of Physical Activity Measures Using Mobile Phone-Based CalFit and Actigraph %A Donaire-Gonzalez,David %A de Nazelle,Audrey %A Seto,Edmund %A Mendez,Michelle %A Nieuwenhuijsen,Mark J %A Jerrett,Michael %+ Center for Research in Environmental Epidemiology (CREAL), C Doctor Aiguader, 88., Barcelona, Catalonia, 08003, Spain, 34 93 2147337, mnieuwenhuijsen@creal.cat %K cellular phone %K accelerometry %K global positioning systems %K motor activity %K monitoring %K physiologic %D 2013 %7 13.06.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Epidemiological studies on physical activity often lack inexpensive, objective, valid, and reproducible tools for measuring physical activity levels of participants. Novel sensing technologies built into smartphones offer the potential to fill this gap. Objective: We sought to validate estimates of physical activity and determine the usability for large population-based studies of the smartphone-based CalFit software. Methods: A sample of 36 participants from Barcelona, Spain, wore a smartphone with CalFit software and an Actigraph GT3X accelerometer for 5 days. The ease of use (usability) and physical activity measures from both devices were compared, including vertical axis counts (VT) and duration and energy expenditure predictions for light, moderate, and vigorous intensity from Freedson’s algorithm. Statistical analyses included (1) Kruskal-Wallis rank sum test for usability measures, (2) Spearman correlation and linear regression for VT counts, (3) concordance correlation coefficient (CCC), and (4) Bland-Altman plots for duration and energy expenditure measures. Results: Approximately 64% (23/36) of participants were women. Mean age was 31 years (SD 8) and mean body mass index was 22 kg/m2 (SD 2). In total, 25/36 (69%) participants recorded at least 3 days with at least 10 recorded hours of physical activity using CalFit. The linear association and correlations for VT counts were high (adjusted R2=0.85; correlation coefficient .932, 95% CI 0.931-0.933). CCCs showed high agreement for duration and energy expenditure measures (from 0.83 to 0.91). Conclusions: The CalFit system had lower usability than the Actigraph GT3X because the application lacked a means to turn itself on each time the smartphone was powered on. The CalFit system may provide valid estimates to quantify and classify physical activity. CalFit may prove to be more cost-effective and easily deployed for large-scale population health studies than other specialized instruments because cell phones are already carried by many people. %M 23896156 %R 10.2196/jmir.2470 %U http://www.jmir.org/2013/6/e111/ %U https://doi.org/10.2196/jmir.2470 %U http://www.ncbi.nlm.nih.gov/pubmed/23896156 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 6 %P e110 %T Two Fully Automated Web-Based Interventions for Risky Alcohol Use: Randomized Controlled Trial %A Tensil,Marc-Dennan %A Jonas,Benjamin %A Strüber,Evelin %+ Delphi-Gesellschaft, Kaiserdamm 8, Berlin, 14057, Germany, 49 30 39 40 97 85, tensil@delphi-gesellschaft.de %K alcohol abuse %K binge drinking %K Internet intervention %K relapse prevention %K randomized controlled trial %D 2013 %7 06.06.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Excessive alcohol use is a widespread problem in many countries, especially among young people. To reach more people engaging in high-risk drinking behaviors, a number of online programs have been developed in recent years. Change Your Drinking is a German, diary-based, fully automated alcohol intervention. In 2010, a revised version of the program was developed. It is more strongly oriented to concepts of relapse prevention than the previous version, includes more feedback, and offers more possibilities to interact with the program. Moreover, the program duration was extended from 10 to 14 days. Objective: This paper examines whether the revised version of Change Your Drinking is more effective in reducing alcohol consumption than the original version. Methods: The effectiveness of both program versions was compared in a Web-based, open, randomized controlled trial with follow-up surveys 6 weeks and 3 months after registration. Participants were recruited online and were randomly assigned to either the original or the revised version of Change Your Drinking. The following self-assessed outcomes were used: alcohol use days, alcohol intake in grams, the occurrence of binge drinking and risky drinking (all referring to the past 7 days prior to each survey), and the number of alcohol-related problems. Results: A total of 595 participants were included in the trial. Follow-up rates were 58.0% after 6 weeks and 49.6% after 3 months. No significant group differences were found in any of the outcomes. However, the revised version was used by more participants (80.7%) than the original version (55.7%). A significant time effect was detected in all outcomes (alcohol use days: P=.002; alcohol intake in grams: P<.001; binge drinking: P<.001; alcohol-related problems: P=.004; risky drinking: P<.001). Conclusions: The duration and complexity of the program played a minor role in reducing alcohol consumption. However, differences in program usage between the versions suggest the revised version was more attractive to participants. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 31586428; http://www.controlled-trials.com/ISRCTN31586428/ (Archived by WebCite at http://www.webcitation.org/6BFxApCUT) %M 23742808 %R 10.2196/jmir.2489 %U http://www.jmir.org/2013/6/e110/ %U https://doi.org/10.2196/jmir.2489 %U http://www.ncbi.nlm.nih.gov/pubmed/23742808 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 5 %P e101 %T Technology-Based Interventions for Mental Health in Tertiary Students: Systematic Review %A Farrer,Louise %A Gulliver,Amelia %A Chan,Jade KY %A Batterham,Philip J %A Reynolds,Julia %A Calear,Alison %A Tait,Robert %A Bennett,Kylie %A Griffiths,Kathleen M %+ Centre for Mental Health Research, The Australian National University, Building 63, Eggleston Road, The Australian National University, Canberra ACT, 0200, Australia, 61 2 6125 8859, louise.farrer@anu.edu.au %K systematic review %K technology %K intervention %K universities %K students %K mental health %D 2013 %7 27.05.2013 %9 Review %J J Med Internet Res %G English %X Background: Mental disorders are responsible for a high level of disability burden in students attending university. However, many universities have limited resources available to support student mental health. Technology-based interventions may be highly relevant to university populations. Previous reviews have targeted substance use and eating disorders in tertiary students. However, the effectiveness of technology-based interventions for other mental disorders and related issues has not been reviewed. Objective: To systematically review published randomized trials of technology-based interventions evaluated in a university setting for disorders other than substance use and eating disorders. Methods: The PubMed, PsycInfo, and Cochrane Central Register of Controlled Trials databases were searched using keywords, phrases, and MeSH terms. Retrieved abstracts (n=1618) were double screened and coded. Included studies met the following criteria: (1) the study was a randomized trial or a randomized controlled trial, (2) the sample was composed of students attending a tertiary institution, (3) the intervention was delivered by or accessed using a technological device or process, (4) the age range of the sample was between 18 and 25 years, and (5) the intervention was designed to improve, reduce, or change symptoms relating to a mental disorder. Results: A total of 27 studies met inclusion criteria for the present review. Most of the studies (24/27, 89%) employed interventions targeting anxiety symptoms or disorders or stress, although almost one-third (7/24, 29%) targeted both depression and anxiety. There were a total of 51 technology-based interventions employed across the 27 studies. Overall, approximately half (24/51, 47%) were associated with at least 1 significant positive outcome compared with the control at postintervention. However, 29% (15/51) failed to find a significant effect. Effect sizes were calculated for the 18 of 51 interventions that provided sufficient data. Median effect size was 0.54 (range –0.07 to 3.04) for 8 interventions targeting depression and anxiety symptoms and 0.84 (range –0.07 to 2.66) for 10 interventions targeting anxiety symptoms and disorders. Internet-based technology (typically involving cognitive behavioral therapy) was the most commonly employed medium, being employed in 16 of 27 studies and approximately half of the 51 technology-based interventions (25/51, 49%). Distal and universal preventive interventions were the most common type of intervention. Some methodological problems were evident in the studies, with randomization methods either inadequate or inadequately described, few studies specifying a primary outcome, and most of the studies failing to undertake or report appropriate intent-to-treat analyses. Conclusions: The findings of this review indicate that although technological interventions targeting certain mental health and related problems offer promise for students in university settings, more high quality trials that fully report randomization methods, outcome data, and data analysis methods are needed. %M 23711740 %R 10.2196/jmir.2639 %U http://www.jmir.org/2013/5/e101/ %U https://doi.org/10.2196/jmir.2639 %U http://www.ncbi.nlm.nih.gov/pubmed/23711740 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 5 %P e99 %T Web-Based Counseling for Problem Gambling: Exploring Motivations and Recommendations %A Rodda,Simone %A Lubman,Dan I %A Dowling,Nicki A %A Bough,Anna %A Jackson,Alun C %+ Turning Point Alcohol and Drug Centre, 54-62 Gertrude Street, Fitzroy, 3065, Australia, 61 0384138433, simoner@turningpoint.org.au %K Internet %K motivation %K gambling %K counseling %K Web-based interventions %K health services accessibility %D 2013 %7 24.05.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: For highly stigmatized disorders, such as problem gambling, Web-based counseling has the potential to address common barriers to treatment, including issues of shame and stigma. Despite the exponential growth in the uptake of immediate synchronous Web-based counseling (ie, provided without appointment), little is known about why people choose this service over other modes of treatment. Objective: The aim of the current study was to determine motivations for choosing and recommending Web-based counseling over telephone or face-to-face services. Methods: The study involved 233 Australian participants who had completed an online counseling session for problem gambling on the Gambling Help Online website between November 2010 and February 2012. Participants were all classified as problem gamblers, with a greater proportion of males (57.4%) and 60.4% younger than 40 years of age. Participants completed open-ended questions about their reasons for choosing online counseling over other modes (ie, face-to-face and telephone), as well as reasons for recommending the service to others. Results: A content analysis revealed 4 themes related to confidentiality/anonymity (reported by 27.0%), convenience/accessibility (50.9%), service system access (34.2%), and a preference for the therapeutic medium (26.6%). Few participants reported helpful professional support as a reason for accessing counseling online, but 43.2% of participants stated that this was a reason for recommending the service. Those older than 40 years were more likely than younger people in the sample to use Web-based counseling as an entry point into the service system (P=.045), whereas those engaged in nonstrategic gambling (eg, machine gambling) were more likely to access online counseling as an entry into the service system than those engaged in strategic gambling (ie, cards, sports; P=.01). Participants older than 40 years were more likely to recommend the service because of its potential for confidentiality and anonymity (P=.04), whereas those younger than 40 years were more likely to recommend the service due to it being helpful (P=.02). Conclusions: This study provides important information about why online counseling for gambling is attractive to people with problem gambling, thereby informing the development of targeted online programs, campaigns, and promotional material. %R 10.2196/jmir.2474 %U http://www.jmir.org/2013/5/e99/ %U https://doi.org/10.2196/jmir.2474 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 5 %P e96 %T Predictors of Participant Retention in a Guided Online Self-Help Program for University Students: Prospective Cohort Study %A Wojtowicz,Magdalena %A Day,Victor %A McGrath,Patrick J %+ Department of Psychology and Neuroscience, Dalhousie University, 1355 Oxford Street, Life Sciences Centre, Halifax, NS, B3H 4J1, Canada, 1 902 473 2581, m.wojtowicz@dal.ca %K self-help %K online treatment %K Web-based %K retention %K dropouts %K theory of planned behavior %D 2013 %7 22.05.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Attrition is a persistent issue in online self-help programs, but limited research is available on reasons for attrition or successful methods for improving participant retention. One potential approach to understanding attrition and retention in such programs is to examine person-related variables (eg, beliefs and attitudes) that influence behavior. Theoretical models, such as the Theory of Planned Behavior, that describe conditions influencing human behavior may provide a useful framework for predicting participant retention in online-based program. Objective: We examined predictors of participant retention in a guided online anxiety, depression, and stress self-help program for university students using the theory of planned behavior. We also explored whether age, symptom severity, and type of coaching (ie, email vs phone) affected participant retention. Methods: 65 university students with mild to moderate depression, anxiety, and stress were enrolled in this prospective cohort study. Participants completed a questionnaire based on the theory of planned behavior prior to commencing the online-based program and the Depression Anxiety and Stress Scale (DASS) during the assessment module of the program. Participant retention was operationalized as the number of program modules completed. Results: Perceived control over completing the online program significantly predicted intention to complete the program (F3,62=6.7; P=.001; adjusted R2=.2; standardized beta=.436, P=.001). Age (standardized beta=.319, P=.03) and perceived behavioral control (standardized beta=.295, P=.05) predicted the number of program modules completed (F3,61=3.20, P=.03, adjusted R2 =.11). Initial level of distress (ie, symptom severity) did not predict participant retention (P=.55). Participants who chose phone-based coaching completed more program modules than participants who chose email-based coaching (Mann-Whitney’s U=137; P=.004). Conclusions: Participants’ age, level of perceived behavioral control, and choice of interaction (ie, phone-based or email-based coaching) were found to influence retention in this online-based program. %M 23697614 %R 10.2196/jmir.2323 %U http://www.jmir.org/2013/5/e96/ %U https://doi.org/10.2196/jmir.2323 %U http://www.ncbi.nlm.nih.gov/pubmed/23697614 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 5 %P e83 %T Making Sense of Mobile- and Web-Based Wellness Information Technology: Cross-Generational Study %A Kutz,Daniel %A Shankar,Kalpana %A Connelly,Kay %+ School of Library and Information Science, Indiana University, 1320 E. 10th St., LI 011, Bloomington, IN, 47405-3907, United States, 1 8128552018, dokutz@indiana.edu %K ubiquitous computing %K health promotion %K wellness %K human-computer interaction %K design %K generational differences %D 2013 %7 14.05.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: A recent trend in personal health and wellness management is the development of computerized applications or information and communication technologies (ICTs) that support behavioral change, aid the management of chronic conditions, or help an individual manage their wellness and engage in a healthier lifestyle. Objective: To understand how individuals across 3 generations (young, middle-aged, and older) think about the design and use of collaborative health and wellness management technologies and what roles these could take in their lives. Methods: Face-to-face semistructured interviews, paper prototype systems, and video skits were used to assess how individuals from 3 age cohorts (young: 18-25 years; middle-aged: 35-50 years; and older: ≥65 years) conceptualize the role that health and wellness computing could take in their lives. Results: A total of 21 participants in the 3 age cohorts took part (young: n=7; middle-aged: n=7; and older: n=7). Young adults expected to be able to actively manage the presentation of their health-related information. Middle-aged adults had more nuanced expectations that reflect their engagement with work and other life activities. Older adults questioned the sharing of health information with a larger audience, although they saw the value in 1-way sharing between family members or providing aggregated information. Conclusions: Our findings inform our suggestions for improving the design of future collaborative health and wellness applications that target specific age groups. We recommend that collaborative ICT health applications targeting young adults should integrate with existing social networking sites, whereas those targeting middle-aged and older adults should support small social networks that rely on intimate personal relationships. Systems that target middle-aged adults should support episodic needs, such as time-sensitive, perhaps intermittent, goal setting. They should also have a low barrier to entry, allowing individuals who do not normally engage with the Internet to participate with the application for the specific purposes of health engagement. Collaborative ICT health applications targeting older adults should allow discreet 1-way sharing, and also support sharing of information in aggregate with others’ data. These systems should also provide mechanisms to preselect recipients of different kinds of data, or to easily direct specific information to individuals in real time. %M 23900035 %R 10.2196/jmir.2124 %U http://www.jmir.org/2013/5/e83/ %U https://doi.org/10.2196/jmir.2124 %U http://www.ncbi.nlm.nih.gov/pubmed/23900035 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 5 %P e82 %T Internet-Delivered Interpersonal Psychotherapy Versus Internet-Delivered Cognitive Behavioral Therapy for Adults With Depressive Symptoms: Randomized Controlled Noninferiority Trial %A Donker,Tara %A Bennett,Kylie %A Bennett,Anthony %A Mackinnon,Andrew %A van Straten,Annemieke %A Cuijpers,Pim %A Christensen,Helen %A Griffiths,Kathleen M %+ Black Dog Institute, University of New South Wales, Hospital Road, Sydney, 2031, Australia, 61 2 9382 4522, t.donker@unsw.edu.au %K interpersonal relations %K cognitive behavior therapy %K depressive disorder %K Internet %K randomized controlled trial %D 2013 %7 13.05.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Face-to-face cognitive behavioral therapy (CBT) and interpersonal psychotherapy (IPT) are both effective treatments for depressive disorders, but access is limited. Online CBT interventions have demonstrated efficacy in decreasing depressive symptoms and can facilitate the dissemination of therapies among the public. However, the efficacy of Internet-delivered IPT is as yet unknown. Objective: This study examines whether IPT is effective, noninferior to, and as feasible as CBT when delivered online to spontaneous visitors of an online therapy website. Methods: An automated, 3-arm, fully self-guided, online noninferiority trial compared 2 new treatments (IPT: n=620; CBT: n=610) to an active control treatment (MoodGYM: n=613) over a 4-week period in the general population. Outcomes were assessed using online self-report questionnaires, the Center for Epidemiological Studies Depression scale (CES-D) and the Client Satisfaction Questionnaire (CSQ-8) completed immediately following treatment (posttest) and at 6-month follow-up. Results: Completers analyses showed a significant reduction in depressive symptoms at posttest and follow-up for both CBT and IPT, and were noninferior to MoodGYM. Within-group effect sizes were medium to large for all groups. There were no differences in clinical significant change between the programs. Reliable change was shown at posttest and follow-up for all programs, with consistently higher rates for CBT. Participants allocated to IPT showed significantly lower treatment satisfaction compared to CBT and MoodGYM. There was a dropout rate of 1294/1843 (70%) at posttest, highest for MoodGYM. Intention-to-treat analyses confirmed these findings. Conclusions: Despite a high dropout rate and lower satisfaction scores, this study suggests that Internet-delivered self-guided IPT is effective in reducing depressive symptoms, and may be noninferior to MoodGYM. The completion rates of IPT and CBT were higher than MoodGYM, indicating some progress in refining Internet-based self-help. Internet-delivered treatment options available for people suffering from depression now include IPT. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 69603913; http://www.controlled-trials.com/ISRCTN69603913 (Archived by WebCite at http://www.webcitation.org/6FjMhmE1o) %M 23669884 %R 10.2196/jmir.2307 %U http://www.jmir.org/2013/5/e82/ %U https://doi.org/10.2196/jmir.2307 %U http://www.ncbi.nlm.nih.gov/pubmed/23669884 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 5 %P e77 %T Who Participates in Web-Assisted Tobacco Interventions? The Quit-Primo and National Dental Practice-Based Research Network Hi-Quit Studies %A Sadasivam,Rajani Shankar %A Kinney,Rebecca L %A Delaughter,Kathryn %A Rao,Sowmya R %A Williams,Jessica Hillman %A Coley,Heather L %A Ray,Midge N %A Gilbert,Gregg H %A Allison,Jeroan J %A Ford,Daniel E %A Houston,Thomas K %A , %+ Division of Health Informatics & Implementation Science, University of Massachusetts Medical School, 55 Lake Ave North, Worcester, MA, , United States, 1 5089254846, rajani.sadasivam@umassmed.edu %K smoking cessation %K Web-assisted tobacco intervention %K Google advertisements %K medical practice %K dental practice %K public health informatics %D 2013 %7 01.05.2013 %9 Original Paper %J J Med Internet Res %G English %X Introduction: Smoking is the most preventable cause of death. Although effective, Web-assisted tobacco interventions are underutilized and recruitment is challenging. Understanding who participates in Web-assisted tobacco interventions may help in improving recruitment. Objectives: To understand characteristics of smokers participating in a Web-assisted tobacco intervention (Decide2Quit.org). Methods: In addition to the typical Google advertisements, we expanded Decide2Quit.org recruitment to include referrals from medical and dental providers. We assessed how the expanded recruitment of smokers changed the users’ characteristics, including comparison with a population-based sample of smokers from the national Behavioral Risk Factors Surveillance Survey (BRFSS). Using a negative binomial regression, we compared demographic and smoking characteristics by recruitment source, in particular readiness to quit and association with subsequent Decide2Quit.org use. Results: The Decide2Quit.org cohort included 605 smokers; the 2010 BRFSS dataset included 69,992. Compared to BRFSS smokers, a higher proportion of Decide2Quit.org smokers were female (65.2% vs 45.7%, P=.001), over age 35 (80.8% vs 67.0%, P=.001), and had some college or were college graduates (65.7% vs 45.9%, P=.001). Demographic and smoking characteristics varied by recruitment; for example, a lower proportion of medical- (22.1%) and dental-referred (18.9%) smokers had set a quit date or had already quit than Google smokers (40.1%, P<.001). Medical- and dental-referred smokers were less likely to use Decide2Quit.org functions; in adjusted analysis, Google smokers (predicted count 17.04, 95% CI 14.97-19.11) had higher predicted counts of Web page visits than medical-referred (predicted count 12.73, 95% CI 11.42-14.04) and dental-referred (predicted count 11.97, 95% CI 10.13-13.82) smokers, and were more likely to contact tobacco treatment specialists. Conclusions: Recruitment from clinical practices complimented Google recruitment attracting smokers less motivated to quit and less experienced with Web-assisted tobacco interventions. Trial Registration: Clinicaltrials.gov NCT00797628; http://clinicaltrials.gov/ct2/show/NCT00797628 (Archived by WebCite at http://www.webcitation.org/6F3tqz0b3) %M 23635417 %R 10.2196/jmir.2385 %U http://www.jmir.org/2013/5/e77/ %U https://doi.org/10.2196/jmir.2385 %U http://www.ncbi.nlm.nih.gov/pubmed/23635417 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 4 %P e84 %T Multilevel Growth Curve Analyses of Treatment Effects of a Web-Based Intervention for Stress Reduction: Randomized Controlled Trial %A Drozd,Filip %A Raeder,Sabine %A Kraft,Pål %A Bjørkli,Cato Alexander %+ Research and Development, Changetech AS, Changetech AS, Gaustadalléen 21, Oslo, N-0349, Norway, 47 97516188, fd@changetech.no %K stress, multilevel modeling, randomized controlled trial, mindfulness, procrastination, multiple mediation, multiple moderation, Web %D 2013 %7 22.04.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Stress is commonly experienced by many people and it is a contributing factor to many mental and physical health conditions, However, few efforts have been made to develop and test the effects of interventions for stress. Objective: The aim of this study was to examine the effects of a Web-based stress-reduction intervention on stress, investigate mindfulness and procrastination as potential mediators of any treatment effects, and test whether the intervention is equally effective for females as males, all ages, and all levels of education. Methods: We employed a randomized controlled trial in this study. Participants were recruited online via Facebook and randomly assigned to either the stress intervention or a control condition. The Web-based stress intervention was fully automated and consisted of 13 sessions over 1 month. The controls were informed that they would get access to the intervention after the final data collection. Data were collected at baseline and at 1, 2, and 6 months after intervention onset by means of online questionnaires. Outcomes were stress, mindfulness, and procrastination, which were all measured at every measurement occasion. Results: A total of 259 participants were included and were allocated to either the stress intervention (n=126) or the control condition (n=133). Participants in the intervention and control group were comparable at baseline; however, results revealed that participants in the stress intervention followed a statistically different (ie, cubic) developmental trajectory in stress levels over time compared to the controls. A growth curve analysis showed that participants in the stress intervention (unstandardized beta coefficient [B]=–3.45, P=.008) recovered more quickly compared to the control group (B=–0.81, P=.34) from baseline to 1 month. Although participants in the stress intervention did show increases in stress levels during the study period (B=2.23, P=.008), long-term stress levels did decrease again toward study end at 6 months (B=–0.28, P=.009). Stress levels in the control group, however, remained largely unchanged after 1 month (B=0.29, P=.61) and toward 6 months (B=–0.03, P=.67). Mediation analyses showed nonlinear (ie, cubic) specific indirect effects of mindfulness and a linear specific indirect effect of procrastination on stress. In simple terms, the intervention increased mindfulness and decreased procrastination, which was related to lower stress levels. Finally, the effect of the stress intervention was independent of participants’ gender, age, or education. Conclusions: The results from this randomized controlled trial suggest that a Web-based intervention can reduce levels of stress in a normal population and that both mindfulness and procrastination may be important components included in future eHealth interventions for stress. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 25619675; http://controlled-trials.com/ISRCTN25619675 (Archived by Webcite at http://www.webcitation.org/6FxB1gOKY) %M 23607962 %R 10.2196/jmir.2570 %U http://www.jmir.org/2013/4/e84/ %U https://doi.org/10.2196/jmir.2570 %U http://www.ncbi.nlm.nih.gov/pubmed/23607962 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 15 %N 3 %P e64 %T Internet-Based Photoaging Within Australian Pharmacies to Promote Smoking Cessation: Randomized Controlled Trial %A Burford,Oksana %A Jiwa,Moyez %A Carter,Owen %A Parsons,Richard %A Hendrie,Delia %+ Curtin Health Innovation Research Institute, School of Pharmacy, Curtin University, GPO Box U1987, Perth, 6845, Australia, 61 8 9266 7201, O.Burford@curtin.edu.au %K smoking %K tobacco use disorder %K skin aging %D 2013 %7 26.03.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Tobacco smoking leads to death or disability and a drain on national resources. The literature suggests that cigarette smoking continues to be a major modifiable risk factor for a variety of diseases and that smokers aged 18-30 years are relatively resistant to antismoking messages due to their widely held belief that they will not be lifelong smokers. Objective: To conduct a randomized controlled trial (RCT) of a computer-generated photoaging intervention to promote smoking cessation among young adult smokers within a community pharmacy setting. Methods: A trial was designed with 80% power based on the effect size observed in a published pilot study; 160 subjects were recruited (80 allocated to the control group and 80 to the intervention group) from 8 metropolitan community pharmacies located around Perth city center in Western Australia. All participants received standardized smoking cessation advice. The intervention group participants were also digitally photoaged by using the Internet-based APRIL Face Aging software so they could preview images of themselves as a lifelong smoker and as a nonsmoker. Due to the nature of the intervention, the participants and researcher could not be blinded to the study. The main outcome measure was quit attempts at 6-month follow-up, both self-reported and biochemically validated through testing for carbon monoxide (CO), and nicotine dependence assessed via the Fagerström scale. Results: At 6-month follow-up, 5 of 80 control group participants (6.3%) suggested they had quit smoking, but only 1 of 80 control group participants (1.3%) consented to, and was confirmed by, CO validation. In the intervention group, 22 of 80 participants (27.5%) reported quitting, with 11 of 80 participants (13.8%) confirmed by CO testing. This difference in biochemically confirmed quit attempts was statistically significant (χ21=9.0, P=.003). A repeated measures analysis suggested the average intervention group smoking dependence score had also significantly dropped compared to control participants (P<.001). These differences remained statistically significant after adjustment for small differences in gender distribution and nicotine dependence between the groups. The mean cost of implementing the intervention was estimated at AU $5.79 per participant. The incremental cost-effectiveness ratio was AU $46 per additional quitter. The mean cost that participants indicated they were willing to pay for the digital aging service was AU $20.25 (SD 15.32). Conclusions: Demonstrating the detrimental effects on facial physical appearance by using a computer-generated simulation may be both effective and cost-effective at persuading young adult smokers to quit. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12609000885291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12609000885291 (Archived by WebCite at http://www.webcitation.org/6F2kMt3kC) %M 23531984 %R 10.2196/jmir.2337 %U http://www.jmir.org/2013/3/e64/ %U https://doi.org/10.2196/jmir.2337 %U http://www.ncbi.nlm.nih.gov/pubmed/23531984 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 15 %N 3 %P e69 %T The Effect of Program Design on Engagement With an Internet-Based Smoking Intervention: Randomized Factorial Trial %A McClure,Jennifer B %A Shortreed,Susan M %A Bogart,Andy %A Derry,Holly %A Riggs,Karin %A St John,Jackie %A Nair,Vijay %A An,Larry %+ Group Health Research Institute, 1730 Minor Ave., Suite 1600, Seattle, WA, 98101, United States, 1 206 287 2737, McClure.J@ghc.org %K smoking cessation %K utilization %K Internet %K behavioral research %K electronic mail %K motivation %D 2013 %7 25.03.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Participant engagement influences treatment effectiveness, but it is unknown which intervention design features increase treatment engagement for online smoking cessation programs. Objective: We explored the effects of 4 design features (ie, factors) on early engagement with an Internet-based, motivational smoking cessation program. Methods: Smokers (N=1865) were recruited from a large health care organization to participate in an online intervention study, regardless of their interest in quitting smoking. The program was intended to answer smokers’ questions about quitting in an effort to motivate and support cessation. Consistent with the screening phase in the multiphase optimization strategy (MOST), we used a 2-level, full-factorial design. Each person was randomized to 1 of 2 levels of each factor, including message tone (prescriptive vs motivational), navigation autonomy (dictated vs not), proactive email reminders (yes vs no), and inclusion of personally tailored testimonials (yes vs no). The effects of each factor level on program engagement during the first 2 months of enrollment were compared, including number of visits to the website resulting in intervention content views (as opposed to supplemental content views), number of intervention content areas viewed, number of intervention content pages viewed, and duration of time spent viewing this content, as applicable to each factor. Results: Adjusting for baseline readiness to quit, persons who received content written in a prescriptive tone made the same number of visits to the website as persons receiving content in a motivational tone, but viewed 1.17 times as many content areas (95% CI 1.08-1.28; P<.001) and 1.15 times as many pages (95% CI 1.04-1.28; P=.009). Time spent viewing materials did not differ among groups (P=.06). Persons required to view content in a dictated order based on their initial readiness to quit made the same number of visits as people able to freely navigate the site, but viewed fewer content areas (ratio of means 0.80, 95% CI 0.74-0.87; P<.001), 1.17 times as many pages (95% CI 1.06-1.31; P=.003), and spent 1.37 times more minutes online (95% CI 1.17-1.59; P<.001). Persons receiving proactive email reminders made 1.20 times as many visits (95% CI 1.09-1.33; P<.001), viewed a similar number of content areas as persons receiving no reminders, viewed 1.58 times as many pages (95% CI 1.48-1.68; P<.001), and spent 1.51 times as many minutes online (95% CI 1.29-1.77; P<.001) as those who did not receive proactive emails. Tailored testimonials did not significantly affect engagement. Conclusions: Using a prescriptive message tone, dictating content viewing order, and sending reminder emails each resulted in greater program engagement relative to the contrasting level of each experimental factor. The results require replication, but suggest that a more directive interaction style may be preferable for online cessation programs. Trial Registration: clinicaltrials.gov NCT00992264; http://clinicaltrials.gov/ct2/show/NCT00992264 (Archived by WebCite at http://www.webcitation.org/6F7H7lr3P) %M 23529377 %R 10.2196/jmir.2508 %U http://www.jmir.org/2013/3/e69/ %U https://doi.org/10.2196/jmir.2508 %U http://www.ncbi.nlm.nih.gov/pubmed/23529377 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 15 %N 3 %P e50 %T Prevalence and Characteristics of Smokers Interested in Internet-Based Smoking Cessation Interventions: Cross-sectional Findings From a National Household Survey %A Brown,Jamie %A Michie,Susan %A Raupach,Tobias %A West,Robert %+ Cancer Research UK Health Behaviour Research Centre, Department of Public Health and Epidemiology, University College London, 1-19 Torrington Place, London, WC1E 6BT, United Kingdom, 44 7717886880, jamie.brown@ucl.ac.uk %K smoking cessation intervention %K Internet-based %K website %K prevalence %K characteristic %D 2013 %7 18.03.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: An accurate and up-to-date estimate of the potential reach of Internet-based smoking cessation interventions (ISCIs) would improve calculations of impact while an understanding of the characteristics of potential users would facilitate the design of interventions. Objective: This study reports the prevalence and the sociodemographic, smoking, and Internet-use characteristics of smokers interested in using ISCIs in a nationally representative sample. Methods: Data were collected using cross-sectional household surveys of representative samples of adults in England. Interest in trying an Internet site or “app” that was proven to help with stopping smoking was assessed in 1128 adult smokers in addition to sociodemographic characteristics, dependence, motivation to quit, previous attempts to quit smoking, Internet and handheld computer access, and recent types of information searched online. Results: Of a representative sample of current smokers, 46.6% (95% CI 43.5%-49.6%) were interested in using an Internet-based smoking cessation intervention. In contrast, only 0.3% (95% CI 0%-0.7%) of smokers reported having used such an intervention to support their most recent quit attempt within the past year. After adjusting for all other background characteristics, interested smokers were younger (OR=0.98, 95% CI 0.97-0.99), reported stronger urges (OR=1.29, 95% CI 1.10-1.51), were more motivated to quit within 3 months (OR=2.16, 95% CI 1.54-3.02), and were more likely to have made a quit attempt in the past year (OR=1.76, 95% CI 1.30-2.37), access the Internet at least weekly (OR=2.17, 95% CI 1.40-3.36), have handheld computer access (OR=1.65, 95% CI 1.22-2.24), and have used the Internet to search for online smoking cessation information or support in past 3 months (OR=2.82, 95% CI 1.20-6.62). There was no association with social grade. Conclusions: Almost half of all smokers in England are interested in using online smoking cessation interventions, yet fewer than 1% have used them to support a quit attempt in the past year. Interest is not associated with social grade but is associated with being younger, more highly motivated, more cigarette dependent, having attempted to quit recently, having regular Internet and handheld computer access, and having recently searched for online smoking cessation information and support. %M 23506944 %R 10.2196/jmir.2342 %U http://www.jmir.org/2013/3/e50/ %U https://doi.org/10.2196/jmir.2342 %U http://www.ncbi.nlm.nih.gov/pubmed/23506944 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 15 %N 3 %P e57 %T Cost-Effectiveness and Cost-Utility of Internet-Based Computer Tailoring for Smoking Cessation %A Smit,Eline Suzanne %A Evers,Silvia MAA %A de Vries,Hein %A Hoving,Ciska %+ CAPHRI School for Public Health and Primary Care, Department of Health Promotion, Maastricht University, PO BOX 616, Maastricht, 6200 MD, Netherlands, 31 433882397, es.smit@maastrichtuniversity.nl %K randomized controlled trial %K economic evaluation %K smoking cessation %K Internet %K computer-tailoring %K general practice %D 2013 %7 14.03.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Although effective smoking cessation interventions exist, information is limited about their cost-effectiveness and cost-utility. Objective: To assess the cost-effectiveness and cost-utility of an Internet-based multiple computer-tailored smoking cessation program and tailored counseling by practice nurses working in Dutch general practices compared with an Internet-based multiple computer-tailored program only and care as usual. Methods: The economic evaluation was embedded in a randomized controlled trial, for which 91 practice nurses recruited 414 eligible smokers. Smokers were randomized to receive multiple tailoring and counseling (n=163), multiple tailoring only (n=132), or usual care (n=119). Self-reported cost and quality of life were assessed during a 12-month follow-up period. Prolonged abstinence and 24-hour and 7-day point prevalence abstinence were assessed at 12-month follow-up. The trial-based economic evaluation was conducted from a societal perspective. Uncertainty was accounted for by bootstrapping (1000 times) and sensitivity analyses. Results: No significant differences were found between the intervention arms with regard to baseline characteristics or effects on abstinence, quality of life, and addiction level. However, participants in the multiple tailoring and counseling group reported significantly more annual health care–related costs than participants in the usual care group. Cost-effectiveness analysis, using prolonged abstinence as the outcome measure, showed that the mere multiple computer-tailored program had the highest probability of being cost-effective. Compared with usual care, in this group €5100 had to be paid for each additional abstinent participant. With regard to cost-utility analyses, using quality of life as the outcome measure, usual care was probably most efficient. Conclusions: To our knowledge, this was the first study to determine the cost-effectiveness and cost-utility of an Internet-based smoking cessation program with and without counseling by a practice nurse. Although the Internet-based multiple computer-tailored program seemed to be the most cost-effective treatment, the cost-utility was probably highest for care as usual. However, to ease the interpretation of cost-effectiveness results, future research should aim at identifying an acceptable cutoff point for the willingness to pay per abstinent participant. %M 23491820 %R 10.2196/jmir.2059 %U http://www.jmir.org/2013/3/e57/ %U https://doi.org/10.2196/jmir.2059 %U http://www.ncbi.nlm.nih.gov/pubmed/23491820 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 15 %N 3 %P e45 %T Recruitment to Online Therapies for Depression: Pilot Cluster Randomized Controlled Trial %A Jones,Ray B %A Goldsmith,Lesley %A Hewson,Paul %A Williams,Christopher J %+ Plymouth University, Faculty of Health, Education, and Society, 3 Portland Villas, Plymouth, PL4 8AA, United Kingdom, 44 441752586532, ray.jones@plymouth.ac.uk %K cluster randomized trial %K pilot study %K online advertising %K depression %K MoodGym %K Living Life to the Full, LLTTF %K cCBT %K Google Analytics %K AdWords %K computerised CBT %D 2013 %7 05.03.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Raising awareness of online cognitive behavioral therapy (CBT) could benefit many people with depression, but we do not know how purchasing online advertising compares to placing free links from relevant local websites in increasing uptake. Objective: To pilot a cluster randomized controlled trial (RCT) comparing purchase of Google AdWords with placing free website links in raising awareness of online CBT resources for depression in order to better understand research design issues. Methods: We compared two online interventions with a control without intervention. The pilot RCT had 4 arms, each with 4 British postcode areas: (A) geographically targeted AdWords, (B) adverts placed on local websites by contacting website owners and requesting links be added, (C) both interventions, (D) control. Participants were directed to our research project website linking to two freely available online CBT resource sites (Moodgym and Living Life To The Full (LLTTF)) and two other depression support sites. We used data from (1) AdWords, (2) Google Analytics for our project website and for LLTTF, and (3) research project website. We compared two outcomes: (1) numbers with depression accessing the research project website, and then chose an onward link to one of the two CBT websites, and (2) numbers registering with LLTTF. We documented costs, and explored intervention and assessment methods to make general recommendations to inform researchers aiming to use similar methodologies in future studies. Results: Trying to place local website links appeared much less cost effective than AdWords and although may prove useful for service delivery, was not worth pursuing in the context of the current study design. Our AdWords intervention was effective in recruiting people to the project website but our location targeting “leaked” and was not as geographically specific as claimed. The impact on online CBT was also diluted by offering participants other choices of destinations. Measuring the impact on LLTTF use was difficult as the total number using LLTTF was less than 5% of all users and record linkage across websites was impossible. Confounding activity may have resulted in some increase in registrations in the control arm. Conclusions: Practitioners should consider online advertising to increase uptake of online therapy but need to check its additional value. A cluster RCT using location targeted adverts is feasible and this research design provides the best evidence of cost-effectiveness. Although our British pilot study is limited to online CBT for depression, a cluster RCT with similar design would be appropriate for other online treatments and countries and our recommendations may apply. They include ways of dealing with possible contamination (buffer zones and AdWords techniques), confounding factors (large number of clusters), advertising dose (in proportion to total number of users), record linkage (landing within target website), and length of study (4-6 months). Trial Registration: clinicaltrials.gov (Registration No. NCT01469689); http://clinicaltrials.gov/ct2/show/NCT01469689 (Archived by WebCite at http://www.webcitation.org/6EtTthDOp) %M 23462072 %R 10.2196/jmir.2367 %U http://www.jmir.org/2013/3/e45/ %U https://doi.org/10.2196/jmir.2367 %U http://www.ncbi.nlm.nih.gov/pubmed/23462072 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 15 %N 3 %P e34 %T How User Characteristics Affect Use Patterns in Web-Based Illness Management Support for Patients with Breast and Prostate Cancer %A Børøsund,Elin %A Cvancarova,Milada %A Ekstedt,Mirjam %A Moore,Shirley M %A Ruland,Cornelia M %+ Centre for Shared Decision Making and Collaborative Care Research, Oslo University Hospital, P.O. Box 4950 Nydalen, Oslo, 0424, Norway, 47 23075452, elin.borosund@rr-research.no %K Web-based intervention %K Internet %K symptom management %K self-care %K use patterns %K user characteristics %K targeting %D 2013 %7 01.03.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Frequently eHealth applications are not used as intended and they have high attrition rates; therefore, a better understanding of patients’ need for support is warranted. Specifically, more research is needed to identify which system components target different patient groups and under what conditions. Objective: To explore user characteristics associated with the use of different system components of a Web-based illness management support system for cancer patients (WebChoice). Methods: For this secondary post hoc analysis of a large randomized controlled trial (RCT), in which WebChoice was tested among 325 breast cancer and prostate cancer patients who were followed with repeated measures for 1 year, usage patterns of 162 cancer patients in the intervention arm with access to WebChoice were extracted from the user log. Logistic regression was performed to identify patterns of associations between system use and patient characteristics. Latent class analyses (LCA) were performed to identify associations among the use of different system components and levels of social support, symptom distress, depression, self-efficacy, and health-related quality of life. Results: Approximately two-thirds (103/162, 63.6%) of the patients logged on to WebChoice more than once, and were defined as users. A high level of computer experience (odds ratio [OR] 3.77, 95% CI 1.20-11.91) and not having other illnesses in addition to cancer (OR 2.10, 95% CI 1.02-4.34) increased the overall probability of using WebChoice. LCA showed that both men with prostate cancer and women with breast cancer who had low scores on social support accompanied with high levels of symptom distress and high levels of depression were more likely to use the e-message component. For men with prostate cancer, these variables were also associated with high use of the self-management advice component. We found important differences between men with prostate cancer and women with breast cancer when associations between WebChoice use and each user characteristic were analyzed separately. High use of all components was associated with low levels of social support among women with breast cancer, but not among men with prostate cancer. High use of e-messages, advice, and the discussion forum were associated with high levels of depression among women with breast cancer, but not among men with prostate cancer. For men with prostate cancer (but not women with breast cancer), high use of symptom assessments, advice, and the discussion forum were associated with high levels of symptom distress. However, it is unclear whether these findings can be attributed to differences related to diagnosis, gender, or both. Conclusions: This study provides evidence that different user characteristics are associated with different use patterns. Such information is crucial to target Web-based support systems to different patient groups. LCA is a useful technique to identify subgroups of users. In our study, e-messages and self-management advice were highly used components for patients who had low levels of social support and high illness burden, suggesting that patients with these characteristics may find such tools particularly useful. Trial Registration: ClinicalTrials.gov NCT00710658; http://clinicaltrials.gov/ct2/show/NCT00710658 (Archived by WebCite at http://www.webcitation.org/6EmEWZiwz) %M 23454601 %R 10.2196/jmir.2285 %U http://www.jmir.org/2013/3/e34/ %U https://doi.org/10.2196/jmir.2285 %U http://www.ncbi.nlm.nih.gov/pubmed/23454601 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 15 %N 2 %P e37 %T A Systematic Review of Web-Based Interventions for Patient Empowerment and Physical Activity in Chronic Diseases: Relevance for Cancer Survivors %A Kuijpers,Wilma %A Groen,Wim G %A Aaronson,Neil K %A van Harten,Wim H %+ Netherlands Cancer Institute, Division of Psychosocial Research and Epidemiology, Plesmanlaan 121, Amsterdam, 1066 CX, Netherlands, 31 205122861, w.v.harten@nki.nl %K systematic review %K Internet intervention %K chronic disease %K patient empowerment %K physical activity %K cancer survivor %D 2013 %7 20.02.2013 %9 Review %J J Med Internet Res %G English %X Background: Patient empowerment reflects the ability of patients to positively influence their health and health behavior such as physical activity. While interactive Web-based interventions are increasingly used in various chronic disease settings to enhance empowerment and physical activity, such interventions are still uncommon for cancer survivors. Objective: The objective of this study was to systematically review the literature regarding interactive Web-based interventions. We focused on interventions aimed at increasing patient empowerment and physical activity for various chronic conditions, and explored their possible relevance for cancer survivors. Methods: Searches were performed in PubMed, Embase, and Scopus to identify peer-reviewed papers reporting on randomized controlled trials that studied the effects of Web-based interventions. These interventions were developed for adults with diabetes, cardiovascular disease, chronic obstructive pulmonary disease, heart failure, or cancer. Intervention characteristics, effects on patient empowerment and physical activity, information on barriers to and facilitators of intervention use, users’ experiences, and methodological quality were assessed. Results were summarized in a qualitative way. We used the recommendations of the Institute of Medicine (IOM) regarding cancer survivorship care to explore the relevance of the interventions for cancer survivors. Results: We included 19 papers reporting on trials with 18 unique studies. Significant, positive effects on patient empowerment were reported by 4 studies and 2 studies reported positive effects on physical activity. The remaining studies yielded mixed results or no significant group differences in these outcomes (ie, no change or improvement for all groups). Although the content, duration, and frequency of interventions varied considerably across studies, commonly used elements included education, self-monitoring, feedback/tailored information, self-management training, personal exercise program, and communication (eg, chat, email) with either health care providers or patients. Limited information was found on barriers, facilitators, and users’ experiences. Methodological quality varied, with 13 studies being of moderate quality. The reported Web-based intervention elements appeared to be highly relevant to address the specific needs of cancer survivors as indicated by the IOM. Conclusions: We identified 7 common elements of interactive, Web-based interventions in chronic disease settings that could possibly be translated into eHealth recommendations for cancer survivors. While further work is needed to determine optimal intervention characteristics, the work performed in other chronic disease settings provides a basis for the design of an interactive eHealth approach to improve patient empowerment and physical activity in cancer survivors. This may subsequently improve their health status and quality of life and reduce their need for supportive care. %M 23425685 %R 10.2196/jmir.2281 %U http://www.jmir.org/2013/2/e37/ %U https://doi.org/10.2196/jmir.2281 %U http://www.ncbi.nlm.nih.gov/pubmed/23425685 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 15 %N 2 %P e38 %T Cost-Effectiveness of a New Internet-Based Monitoring Tool for Neonatal Post-Discharge Home Care %A Isetta,Valentina %A Lopez-Agustina,Carme %A Lopez-Bernal,Esther %A Amat,Maribel %A Vila,Montserrat %A Valls,Carme %A Navajas,Daniel %A Farre,Ramon %+ Unit of Biophysics and Bioengineering, Faculty of Medicine, University of Barcelona, Casanova 143, Barcelona, 08036, Spain, 34 934024515, rfarre@ub.edu %K Telemedicine %K telenursing %K Internet %K neonatology %K cost-effectiveness %D 2013 %7 18.02.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: The application of information and communication technologies in nursing care is becoming more widespread, but few applications have been reported in neonatal care. A close monitoring of newborns within the first weeks of life is crucial to evaluating correct feeding, growth, and health status. Conventional hospital-based postdischarge monitoring could be improved in terms of costs and clinical effectiveness by using a telemedicine approach. Objective: To evaluate the cost-effectiveness of a new Internet-based system for monitoring low-risk newborns after discharge compared to the standard hospital-based follow-up, with specific attention to prevention of emergency department (ED) visits in the first month of life. Methods: We performed a retrospective cohort study of two low-risk newborn patient groups. One group, born between January 1, 2011, and June 30, 2011, received the standard hospital-based follow-up visit within 48 hours after discharge. After implementing an Internet-based monitoring system, another group, born between July 19, 2011, and January 19, 2012, received their follow-up with this system. Results: A total of 18 (15.8%) out of 114 newborns who received the standard hospital-based follow-up had an ED visit in the first month of life compared with 5 (5.6%; P=.026) out of 90 infants who were monitored by the Internet-based system. The cost of the hospital-based follow-up was 182.1€ per patient, compared with 86.1€ for the Internet-based follow-up. Conclusion: Our Internet-based monitoring approach proved to be both more effective and less costly than the conventional hospital-based follow-up, particularly through reducing subsequent ED visits. %M 23419609 %R 10.2196/jmir.2361 %U http://www.jmir.org/2013/2/e38/ %U https://doi.org/10.2196/jmir.2361 %U http://www.ncbi.nlm.nih.gov/pubmed/23419609 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 15 %N 2 %P e26 %T Effectiveness of a Self-Guided Web-Based Cannabis Treatment Program: Randomized Controlled Trial %A Rooke,Sally %A Copeland,Jan %A Norberg,Melissa %A Hine,Donald %A McCambridge,Jim %+ University of New South Wales, 22-32 King Street, Randwick, 2031, Australia, 61 293850450 ext 50450, s.rooke@unsw.edu.au %K marijuana %K Internet intervention %K computer-assisted therapy %K addiction %K randomized controlled trial %D 2013 %7 15.02.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Self-help strategies offer a promising way to address problems with access to and stigma associated with face-to-face drug and alcohol treatment, and the Internet provides an excellent delivery mode for such strategies. To date, no study has tested the effectiveness of a fully self-guided web-based treatment for cannabis use and related problems. Objectives: The current study was a two-armed randomized controlled trial aimed at testing the effectiveness of Reduce Your Use, a fully self-guided web-based treatment program for cannabis use disorder consisting of 6 modules based on cognitive, motivational, and behavioral principles. Methods: 225 individuals who wanted to cease or reduce their cannabis use were recruited using both online and offline advertising methods and were randomly assigned to receive: (1) the web-based intervention, or (2) a control condition consisting of 6 modules of web-based educational information on cannabis. Assessments of cannabis use, dependence symptoms, and abuse symptoms were conducted through online questionnaires at baseline, and at 6-week and 3-month follow-ups. Two sets of data analyses were undertaken—complier average causal effect (CACE) modeling and intention to treat (ITT). Results: Two thirds (149) of the participants completed the 6-week postintervention assessment, while 122 (54%) completed the 3-month follow-up assessment. Participants in the intervention group completed an average of 3.5 of the 6 modules. The CACE analysis revealed that at 6 weeks, the experimental group reported significantly fewer days of cannabis use during the past month (P=.02), significantly lower past-month quantity of cannabis use (P=.01), and significantly fewer symptoms of cannabis abuse (P=.047) relative to controls. Cannabis dependence symptoms (number and severity) and past-month abstinence did not differ significantly between groups (Ps>.05). Findings at 3 months were similar, except that the experimental group reported significantly fewer and less severe cannabis dependence symptoms (Ps<.05), and past-month quantity of cannabis consumed no longer differed significantly between groups (P=.16). ITT analyses yielded similar outcomes. Conclusion: Findings suggest that web-based interventions may be an effective means of treating uncomplicated cannabis use and related problems and reducing the public health burden of cannabis use disorders. Trial registration: ACTRN12609000856213, Australian New Zealand Clinical Trials Registry. %M 23470329 %R 10.2196/jmir.2256 %U http://www.jmir.org/2013/2/e26/ %U https://doi.org/10.2196/jmir.2256 %U http://www.ncbi.nlm.nih.gov/pubmed/23470329 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 15 %N 2 %P e28 %T Influence of Delivery Strategy on Message-Processing Mechanisms and Future Adherence to a Dutch Computer-Tailored Smoking Cessation Intervention %A Stanczyk,Nicola Esther %A Crutzen,Rik %A Bolman,Catherine %A Muris,Jean %A de Vries,Hein %+ Maastricht University/CAPHRI, Department of Health Promotion, Maastricht University, P.Debyeplein 1, Maastricht, 6229 HA, Netherlands, 31 43 388 2226, nicola.stanczyk@maastrichtuniversity.nl %K computer tailoring %K smoking cessation %K message-processing mechanisms %K e-loyalty %K future adherence %D 2013 %7 06.02.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Smoking tobacco is one of the most preventable causes of illness and death. Web-based tailored smoking cessation interventions have shown to be effective. Although these interventions have the potential to reach a large number of smokers, they often face high attrition rates, especially among lower educated smokers. A possible reason for the high attrition rates in the latter group is that computer-tailored smoking cessation interventions may not be attractive enough as they are mainly text-based. Video-based messages might be more effective in attracting attention and stimulating comprehension in people with a lower educational level and could therefore reduce attrition rates. Objective: The objective of the present study was to investigate whether differences exist in message-processing mechanisms (attention, comprehension, self-reference, appreciation, processing) and future adherence (intention to visit/use the website again, recommend the website to others), according to delivery strategy (video or text based messages) and educational level, to a Dutch computer-tailored smoking cessation program. Methods: Smokers who were motivated to quit within the following 6 months and who were aged over 16 were included in the program. Participants were randomly assigned to one of two conditions (video/text CT). The sample was stratified into 2 categories: lower and higher educated participants. In total, 139 participants completed the first session of the web-based tailored intervention and were subsequently asked to fill out a questionnaire assessing message-processing mechanisms and future adherence. ANOVAs and regression analyses were conducted to investigate the differences in message-processing mechanisms and future adherence with regard to delivery strategy and education. Results: No interaction effects were found between delivery strategy (video vs text) and educational level on message-processing mechanisms and future adherence. Delivery strategy had no effect on future adherence and processing mechanisms. However, in both groups results indicated that lower educated participants showed higher attention (F1,138=3.97; P=.05) and processing levels (F1,138=4.58; P=.04). Results revealed also that lower educated participants were more inclined to visit the computer-tailored intervention website again (F1,138=4.43; P=.04). Conclusions: Computer-tailored programs have the potential to positively influence lower educated groups as they might be more involved in the computer-tailored intervention than higher educated smokers. Longitudinal studies with a larger sample are needed to gain more insight into the role of delivery strategy in tailored information and to investigate whether the intention to visit the intervention website again results in the ultimate goal of behavior change. Trial Registration: Netherlands Trial Register (NTR3102). %M 23388554 %R 10.2196/jmir.2153 %U http://www.jmir.org/2013/2/e28/ %U https://doi.org/10.2196/jmir.2153 %U http://www.ncbi.nlm.nih.gov/pubmed/23388554 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 15 %N 2 %P e19 %T Web-based Intervention to Promote Physical Activity by Sedentary Older Adults: Randomized Controlled Trial %A Irvine,A. Blair %A Gelatt,Vicky A %A Seeley,John R %A Macfarlane,Pamela %A Gau,Jeff M %+ ORCAS, 260 E. 11th Avenue,, Eugene, OR, 97401, United States, 1 541 349 4804, birvine@orcasinc.com %K physical activity %K older adults %K Internet %K sedentary %K multi-week %K exercise %D 2013 %7 05.02.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Physical activity (PA) for older adults has well-documented physical and cognitive benefits, but most seniors do not meet recommended guidelines for PA, and interventions are lacking. Objectives: This study evaluated the efficacy of a 12-week Internet intervention to help sedentary older adults over 55 years of age adopt and maintain an exercise regimen. Methods: A total of 368 sedentary men and women (M=60.3; SD 4.9) were recruited, screened, and assessed online. They were randomized into treatment and control groups and assessed at pretest, at 12 weeks, and at 6 months. After treatment group participants rated their fitness level, activity goals, and barriers to exercise, the Internet intervention program helped them select exercise activities in the areas of endurance, flexibility, strengthening, and balance enhancement. They returned to the program weekly for automated video and text support and education, with the option to change or increase their exercise plan. The program also included ongoing problem solving to overcome user-identified barriers to exercise. Results: The multivariate model indicated significant treatment effects at posttest (P=.001; large effect size) and at 6 months (P=.001; medium effect size). At posttest, intervention participation showed significant improvement on 13 of 14 outcome measures compared to the control participants. At 6 months, treatment participants maintained large gains compared to the control participants on all 14 outcome measures. Conclusions: These results suggest that an online PA program has the potential to positively impact the physical activity of sedentary older adult participants. More research is needed to replicate the study results, which were based on self-report measures. Research is also needed on intervention effects with older populations. %M 23470322 %R 10.2196/jmir.2158 %U http://www.jmir.org/2013/2/e19/ %U https://doi.org/10.2196/jmir.2158 %U http://www.ncbi.nlm.nih.gov/pubmed/23470322 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 15 %N 2 %P e12 %T Web-Based Treatment Program Using Intensive Therapeutic Contact for Patients With Eating Disorders: Before-After Study %A ter Huurne,Elke D %A Postel,Marloes G %A de Haan,Hein A %A Drossaert,Constance H.C %A DeJong,Cor A.J %+ Tactus Addiction Treatment, Institutenweg 1, Enschede, , Netherlands, 31 0883822887, e.terhuurne@tactus.nl %K Eating disorders %K eHealth %K Internet %K Web-based treatment %K Intensive therapeutic contact %K Program evaluation %K Treatment effectiveness. %D 2013 %7 04.02.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Although eating disorders are common in the Netherlands, only a few patients are treated by mental health care professionals. To reach and treat more patients with eating disorders, Tactus Addiction Treatment developed a web-based treatment program with asynchronous and intensive personalized communication between the patient and the therapist. Objective: This pilot study evaluated the web-based treatment program using intensive therapeutic contact in a population of 165 patients with an eating disorder. Methods: In a pre-post design with 6-week and 6-month follow-ups, eating disorder psychopathology, body dissatisfaction, Body Mass Index, physical and mental health, and quality of life were measured. The participant’s satisfaction with the web-based treatment program was also studied. Attrition data were collected, and participants were classified as noncompleters if they did not complete all 10 assignments of the web-based treatment program. Differences in baseline characteristics between completers and noncompleters were studied, as well as reasons for noncompletion. Furthermore, differences in treatment effectiveness, treatment adherence, and baseline characteristics between participants of the three major eating disorder diagnostic groups EDNOS (n=115), BN purging (n=24), and BN nonpurging (n=24) were measured. Results: Of the 165 participants who started the web-based treatment program, 89 participants (54%) completed all of the program assignments (completers) and 76 participants (46%) ended the program prematurely (noncompleters). Severe body dissatisfaction and physical and mental health problems seemed to have a negative impact on the completion of the web-based treatment program. Among the participants who completed the treatment program, significant improvements were found in eating disorder psychopathology (F=54.6, df = 68, P<.001, d=1.14). Body dissatisfaction, quality of life, and physical and mental health also significantly improved, and almost all of these positive effects were sustained up to 6 months after the participants had completed the web-based treatment program. Body Mass Index improved only within the group of participants suffering from obesity. The improvement in eating disorder psychopathology occurred in all three eating disorder diagnostic groups, and the percentage of completers did not differ significantly between these groups. Participants’ satisfaction with the treatment program, as well as with their therapist, was high, and participants indicated that they would recommend the program to other patients with eating disorders. Conclusions: The results of this study suggest that the web-based treatment program has the potential to improve eating disorder psychopathology in patients with different types of eating disorders. %M 23380291 %R 10.2196/jmir.2211 %U http://www.jmir.org/2013/2/e12/ %U https://doi.org/10.2196/jmir.2211 %U http://www.ncbi.nlm.nih.gov/pubmed/23380291 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 15 %N 1 %P e23 %T Periodic Email Prompts to Re-Use an Internet-Delivered Computer-Tailored Lifestyle Program: Influence of Prompt Content and Timing %A Schneider,Francine %A de Vries,Hein %A Candel,Math %A van de Kar,Angelique %A van Osch,Liesbeth %+ CAPHRI, Department of Health Promotion, Maastricht University, P.O. Box 616, Maastricht, 6200 MD, Netherlands, 31 433882827, francine.schneider@maastrichtuniversity.nl %K Computer tailoring %K Internet-delivered intervention %K intervention adherence %K periodic email prompts %K prompt content %K prompt timing %D 2013 %7 31.01.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Adherence to Internet-delivered lifestyle interventions using multiple tailoring is suboptimal. Therefore, it is essential to invest in proactive strategies, such as periodic email prompts, to boost re-use of the intervention. Objective: This study investigated the influence of content and timing of a single email prompt on re-use of an Internet-delivered computer-tailored (CT) lifestyle program. Methods: A sample of municipality employees was invited to participate in the program. All participants who decided to use the program received an email prompting them to revisit the program. A 2×3 (content × timing) design was used to test manipulations of prompt content and timing. Depending on the study group participants were randomly assigned to, they received either a prompt containing standard content (an invitation to revisit the program), or standard content plus a preview of new content placed on the program website. Participants received this prompt after 2, 4, or 6 weeks. In addition to these 6 experimental conditions, a control condition was included consisting of participants who did not receive an additional email prompt. Clicks on the uniform resource locator (URL) provided in the prompt and log-ins to the CT program were objectively monitored. Logistic regression analyses were conducted to determine whether prompt content and/or prompt timing predicted clicking on the URL and logging in to the CT program. Results: Of all program users (N=240), 206 participants received a subsequent email prompting them to revisit the program. A total of 53 participants (25.7%) who received a prompt reacted to this prompt by clicking on the URL, and 25 participants (12.1%) actually logged in to the program. There was a main effect of prompt timing; participants receiving an email prompt 2 weeks after their first visit clicked on the URL significantly more often compared with participants that received the prompt after 4 weeks (odds ratio [OR] 3.069, 95% CI 1.392-6.765, P=.005) and after 6 weeks (OR 4.471, 95% CI 1.909-10.471, P=.001). Furthermore, participants who received an email prompt 2 weeks after their first visit logged in to the program significantly more often compared to participants receiving the prompt after 6 weeks (OR 16.356, 95% CI 2.071-129.196, P=.008). A trend was observed with regard to prompt content. Participants receiving a prompt with additional content were more likely to log in to the program compared to participants who received a standard prompt. However, this result was not statistically significant (OR 2.286, 95% CI 0.892-5.856, P=.09). Conclusions: The key findings suggest that boosting revisits to a CT program benefits most from relatively short prompt timing. Furthermore, a preview of new website content may be added to a standard prompt to further increase its effectiveness in persuading people to log in to the program. %M 23363466 %R 10.2196/jmir.2151 %U http://www.jmir.org/2013/1/e23/ %U https://doi.org/10.2196/jmir.2151 %U http://www.ncbi.nlm.nih.gov/pubmed/23363466 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 15 %N 1 %P e15 %T Type 1 Diabetes eHealth Psychoeducation: Youth Recruitment, Participation, and Satisfaction %A Whittemore,Robin %A Jaser,Sarah S %A Faulkner,Melissa S %A Murphy,Kathryn %A Delamater,Alan %A Grey,Margaret %A , %+ Yale, School of Nursing, 100 Church Street South, P.O. Box 9740, New Haven, CT, 06536-0740, United States, 1 203 737 2351, robin.whittemore@yale.edu %K Internet %K patient participation rates %K patient satisfaction %K research subject recruitment youth %D 2013 %7 29.01.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: The Internet and other eHealth technologies offer a platform for improving the dissemination and accessibility of psychoeducational programs for youth with chronic illness. However, little is known about the recruitment process and yield of diverse samples in Internet research with youth who have a chronic illness. Objective: The purpose of this study was to compare the demographic and clinical characteristics of youth with Type 1 diabetes on recruitment, participation, and satisfaction with 2 eHealth psychoeducational programs. Methods: Youth with Type 1 diabetes from 4 sites in the United States were invited to participate (N=510) with 320 eligible youth consenting (mean age=12.3, SD 1.1; 55.3% female; 65.2% white; and mean A1C=8.3, SD 1.5). Data for this secondary analysis included demographic information (age, race/ethnicity, and income), depressive symptoms, and recruitment rates, including those who refused at point of contact (22.0%), passive refusers who consented but did not participate (15.3%), and those who enrolled (62.7%). Participation (80% lessons completed) and a satisfaction survey (ie, how helpful, enjoyable) were also analyzed. Chi-square or analysis of variance (ANOVA) analyses were used. Results: There were significant differences in recruitment rates by income and race/ethnicity such that black, Hispanic, or mixed race/ethnicity and low-income youth were more likely to refuse passively compared to white and higher-income youth who were more likely to enroll (P<.001). Participation in program sessions was high, with 78.1% of youth completing at least 4 of 5 sessions. There were no significant differences in participation by program, age, gender, or race/ethnicity. Low-income youth were less likely to participate (P=.002). Satisfaction in both programs was also high (3.9 of 5). There were significant gender, race/ethnicity, and income differences, in that girls (P=.001), black, Hispanic, or mixed race/ethnicity youth (P=.02), and low-income youth (P=.02) reported higher satisfaction. There were no differences in satisfaction by program or age. Conclusions: Results indicate that black, Hispanic, or mixed race/ethnicity youth and low-income youth with Type 1 diabetes are less likely to enroll in Internet-based research than white and higher-income youth; thus, creative recruitment approaches are needed. Low-income youth were less likely to participate, possibly due to access. However, once enrolled, youth of diverse race/ethnicity and low-income youth with Type 1 diabetes were as highly satisfied with the eHealth programs as white youth and those with higher income. Results suggest that eHealth programs have the potential to reach diverse youth and be appealing to them. %M 23360729 %R 10.2196/jmir.2170 %U http://www.jmir.org/2013/1/e15/ %U https://doi.org/10.2196/jmir.2170 %U http://www.ncbi.nlm.nih.gov/pubmed/23360729 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 15 %N 1 %P e14 %T Engagement Promotes Abstinence in a Web-based Cessation Intervention: Cohort Study %A Richardson,Amanda %A Graham,Amanda L %A Cobb,Nathan %A Xiao,Haijun %A Mushro,Aaron %A Abrams,David %A Vallone,Donna %+ Department of Research and Evaluation, Legacy, 1724 Massachusetts Avenue NW, Washington, DC, 20036, United States, 1 202 454 5571, arichardson@legacyforhealth.org %K Internet %K smoking cessation %K intervention studies %K use effectiveness %D 2013 %7 28.01.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based smoking cessation interventions can have a public health impact because they are both effective in promoting cessation and can reach large numbers of smokers in a cost-efficient manner. Their potential impact, however, has not been realized. It is still unclear how such interventions promote cessation, who benefits most, and how to improve their population impact. Objective: To examine the effectiveness of a highly promoted Web-based smoking cessation intervention to promote quit behavior over time, identify the most effective features, and understand who is most likely to use those features by using unweighted and weighted analyses to estimate the impact in the broader pool of registered site users. Methods: A sample of 1033 new adult registrants was recruited from a Web-based smoking cessation intervention by using an automated study management system. Abstinence was assessed by self-report through a mixed-mode follow-up (online survey with telephone follow-up for nonrespondents) at 1, 3, and 6 months. Software tracked respondents’ online activity. Generalized estimating equations (GEE) were used to examine predictors of website utilization and how utilization promoted abstinence using unweighted and weighted data. Results: The 7-day point prevalence abstinence rates at 6 months ranged from 20.68% to 11.13% in the responder and intent-to-treat samples, respectively. Predictors of abstinence in unweighted analyses included number of visits to the website as well as accessing specific interactive or engaging features. In weighted analyses, only number of visits was predictive of abstinence. Motivation to quit was a key predictor of website utilization, whereas negative partner support decreased the likelihood of increasing visits or accessing engaging features. Conclusions: Engagement is critical to promoting smoking cessation. The next generation of Web-based smoking cessation interventions needs to maximize the initial engagement of all new visitors and work to retain those smokers who proceed to register on the site. %M 23353649 %R 10.2196/jmir.2277 %U http://www.jmir.org/2013/1/e14/ %U https://doi.org/10.2196/jmir.2277 %U http://www.ncbi.nlm.nih.gov/pubmed/23353649 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 15 %N 1 %P e18 %T Evaluating the Translation Process of an Internet-Based Self-Help Intervention for Prevention of Depression: A Cost-Effectiveness Analysis %A Lintvedt,Ove K %A Griffiths,Kathleen M %A Eisemann,Martin %A Waterloo,Knut %+ Faculty of Health Sciences, Department of Psychology, University of Tromsø, Huginbakken 32, Tromsø, N-9037, Norway, 47 77 64 52 90, knut.waterloo@uit.no %K Internet %K Internet intervention %K Cognitive Behavior Therapy %K Quality-Adjusted Life Years %K Cost Effectiveness %K Mental health %K Depression %D 2013 %7 23.01.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression is common and treatable with cognitive behavior therapy (CBT), for example. However, access to this therapy is limited. Internet-based interventions have been found to be effective in reducing symptoms of depression. The International Society for Research on Internet Interventions has highlighted the importance of translating effective Internet programs into multiple languages to enable worldwide dissemination. Objective: The aim of the current study was to determine if it would be cost effective to translate an existing English-language Internet-based intervention for use in a non-English-speaking country. Methods: This paper reports an evaluation of a trial in which a research group in Norway translated two English-language Internet-based interventions into Norwegian (MoodGYM and BluePages) that had previously been shown to reduce symptoms of depression. The translation process and estimates of the cost-effectiveness of such a translation process is described. Estimated health effect was found by using quality-adjusted life years (QALY). Results: Conservative estimates indicate that for every 1000 persons treated, 16 QALYs are gained. The investment is returned 9 times and the cost-effectiveness ratio (CER) is 3432. The costs of the translation project totaled to approximately 27% of the estimated original English-language version development costs. Conclusions: The economic analysis shows that the cost-effectiveness of the translation project was substantial. Hopefully, these results will encourage others to do similar analyses and report cost-effectiveness data in their research reports. %M 23343481 %R 10.2196/jmir.2422 %U http://www.jmir.org/2013/1/e18/ %U https://doi.org/10.2196/jmir.2422 %U http://www.ncbi.nlm.nih.gov/pubmed/23343481 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 15 %N 1 %P e13 %T An Interactive Internet-Based Plate for Assessing Lunchtime Food Intake: A Validation Study on Male Employees %A Svensson,Madeleine %A Bellocco,Rino %A Bakkman,Linda %A Trolle Lagerros,Ylva %+ Karolinska Institutet, Department of Medicine, Unit of Clinical Epidemiology, T2, Stockholm, 171 76, Sweden, 46 8 517 791 73, Madeleine.Svensson@hh.se %K diet %K epidemiology %K Internet %K methods %K nutrition %K validation %K Web %D 2013 %7 18.01.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Misreporting food intake is common because most health screenings rely on self-reports. The more accurate methods (eg, weighing food) are costly, time consuming, and impractical. Objectives: We developed a new instrument for reporting food intake—an Internet-based interactive virtual food plate. The objective of this study was to validate this instrument’s ability to assess lunch intake. Methods: Participants were asked to compose an ordinary lunch meal using both a virtual and a real lunch plate (with real food on a real plate). The participants ate their real lunch meals on-site. Before and after pictures of the composed lunch meals were taken. Both meals included identical food items. Participants were randomized to start with either instrument. The 2 instruments were compared using correlation and concordance measures (total energy intake, nutritional components, quantity of food, and participant characteristics). Results: A total of 55 men (median age: 45 years, median body mass index [BMI]: 25.8 kg/m2) participated. We found an overall overestimation of reported median energy intake using the computer plate (3044 kJ, interquartile range [IQR] 1202 kJ) compared with the real lunch plate (2734 kJ, IQR 1051 kJ, P<.001). Spearman rank correlations and concordance correlations for energy intake and nutritional components ranged between 0.58 to 0.79 and 0.65 to 0.81, respectively. Conclusion: Although it slightly overestimated, our computer plate provides promising results in assessing lunch intake. %M 23335728 %R 10.2196/jmir.2217 %U http://www.jmir.org/2013/1/e13/ %U https://doi.org/10.2196/jmir.2217 %U http://www.ncbi.nlm.nih.gov/pubmed/23335728 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 15 %N 1 %P e11 %T Website Usage and Weight Loss in a Free Commercial Online Weight Loss Program: Retrospective Cohort Study %A Hwang,Kevin O %A Ning,Jing %A Trickey,Amber W %A Sciamanna,Christopher N %+ Department of Internal Medicine, The University of Texas Medical School at Houston, 6410 Fannin St, UPB 1100.41, Houston, TX, 77030, United States, 1 (713) 500 6441, kevin.o.hwang@uth.tmc.edu %K Internet %K Obesity %K Overweight %K Weight loss %K Adherence %K Attrition %D 2013 %7 15.01.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Online weight loss programs are increasingly popular. However, little is known about outcomes and associations with website usage among members of free online weight loss programs. Objective: This retrospective cohort study examined the association between website usage and weight loss among members of a free commercial online weight loss program (SparkPeople). Methods: We conducted a retrospective analysis of a systematic random sample of members who joined the program during February 1 to April 30, 2008, and included follow-up data through May 10, 2010. The main outcome was net weight change based on self-reported weight. Measures of website usage included log-ins, self-monitoring entries (weight, food, exercise), and use of social support tools (discussion forums, friendships). Results: The main sample included 1258 members with at least 2 weight entries. They were 90.7% female, with mean (SD) age 33.6 (11.0) and mean (SD) BMI 31.6 (7.7). Members with at least one forum post lost an additional 1.55 kg (95% CI 0.55 kg to 2.55 kg) relative to those with no forum posts. Having at least 4 log-in days, weight entry days, or food entry days per 30 days was significantly associated with weight loss. In the multiple regression analysis, members with at least 4 weight entry days per 30 days reported 5.09 kg (95% CI 3.29 kg to 6.88 kg) more weight loss per 30 days than those with fewer weight entry days. After controlling for weight entry days, the other website usage variables were not associated with weight change. Conclusions: Weekly or more frequent self-monitoring of weight is associated with greater weight loss among members of this free online weight loss program. %M 23322819 %R 10.2196/jmir.2195 %U http://www.jmir.org/2013/1/e11/ %U https://doi.org/10.2196/jmir.2195 %U http://www.ncbi.nlm.nih.gov/pubmed/23322819 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 15 %N 1 %P e2 %T Effectiveness of a Web-Based Cognitive-Behavioral Tool to Improve Mental Well-Being in the General Population: Randomized Controlled Trial %A Powell,John %A Hamborg,Thomas %A Stallard,Nigel %A Burls,Amanda %A McSorley,Jaime %A Bennett,Kylie %A Griffiths,Kathleen M %A Christensen,Helen %+ Department of Primary Care Health Sciences, University of Oxford, 23-38 Hythe Bridge Street, Oxford, OX1 2ET, United Kingdom, 44 01865617855, john.powell@phc.ox.ac.uk %K Mental health %K Public health %K Randomized controlled trial %K Internet %D 2013 %7 09.01.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Interventions to promote mental well-being can bring benefits to the individual and to society. The Internet can facilitate the large-scale and low-cost delivery of individually targeted health promoting interventions. Objective: To evaluate the effectiveness of a self-directed Internet-delivered cognitive-behavioral skills training tool in improving mental well-being in a population sample. Methods: This was a randomized trial with a waiting-list control. Using advertisements on a national health portal and through its mailing list, we recruited 3070 participants aged 18 or over, resident in England, and willing to give their email address and access a fully automated Web-based intervention. The intervention (MoodGYM) consisted of 5 interactive modules that teach cognitive-behavioral principles. Participants in the intervention arm received weekly email reminders to access the intervention. The control group received access to the intervention after the trial was completed and received no specific intervention or email reminders. Outcomes were assessed by using self-completion questionnaires. The primary outcome was mental well-being measured with the Warwick-Edinburgh Mental Well-being Scale (WEMWBS). Secondary outcomes were Center for Epidemiologic Studies Depression scale (CES-D) depression scores, Generalized Anxiety Disorder 7-item scale (GAD-7) anxiety scores, EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D) quality of life scores, physical activity, and health service use. All outcomes were measured at baseline, and at 6- and 12-week follow-ups. Results: A total of 1529 (49.80%) participants completed final follow-up at 12 weeks. Retention was 73.11% (1123/1536) in the control arm and 26.47% (406/1534) in the intervention arm. No relationship between baseline measures and withdrawal could be established. The analysis of WEMWBS mental well-being scores using a linear mixed model for repeated measures showed no difference between intervention and control group at baseline (difference –0.124 points, 95% CI –0.814 to 0.566), and significant improvements for the intervention group at 6 weeks (2.542 points, 95% CI 1.693-3.390) and at 12 weeks (2.876 points, 95% CI 1.933-3.819). The model showed a highly significant (P<.001) intervention by time interaction effect. There were also significant improvements in self-rated scores of depression and anxiety. Given the high level of attrition, a sensitivity analysis with imputed missing values was undertaken that also showed a significant positive effect of the intervention. Conclusions: Participants allocated to the intervention arm had an average increase of approximately 3 points on the WEMWBS scale compared to no increase for participants in the control group. Three points on this scale is approximately one-third of a standard deviation. In a low-cost automated intervention designed to shift the population distribution of mental well-being, a small difference per individual could yield a major benefit in population terms. In common with other Web-based interventions, there were high rates of attrition. Further work is needed to improve acceptability, to evaluate against placebo effect, and to disaggregate the effect on mental well-being from the effect on depression and anxiety. Trial Registration: International Standard Randomised Controlled Trial Number Register ISRCTN 48134476; http://www.controlled-trials.com/ISRCTN48134476 (Archived by WebCite® at http://www.webcitation.org/6DFgW2p3Q) %M 23302475 %R 10.2196/jmir.2240 %U http://www.jmir.org/2013/1/e2/ %U https://doi.org/10.2196/jmir.2240 %U http://www.ncbi.nlm.nih.gov/pubmed/23302475 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 6 %P e168 %T Mindless Eating Challenge: Retention, Weight Outcomes, and Barriers for Changes in a Public Web-Based Healthy Eating and Weight Loss Program %A Kaipainen,Kirsikka %A Payne,Collin R %A Wansink,Brian %+ VTT Technical Research Centre of Finland, P.O.Box 1300 (Sinitaival 6), Tampere, 33101, Finland, 358 207223036, kirsikka.kaipainen@vtt.fi %K Adherence %K Barriers %K Habits %K Internet %K Self report %K Small changes %K Weight loss programs %D 2012 %7 17.12.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Most dietary programs fail to produce lasting outcomes because participants soon return to their old habits. Small behavioral and environmental changes based on simple heuristics may have the best chance to lead to sustainable habit changes over time. Objective: To evaluate participant retention, weight outcomes, and barriers for changes in a publicly available web-based healthy eating and weight loss program. Methods: The National Mindless Eating Challenge (NMEC) was a publicly available, online healthy eating and weight loss program with ongoing recruitment of participants. This volunteer sample consisted of 2053 participants (mean age 39.8 years, 89% female, 90% white/Caucasian, BMI mean 28.14). Participants completed an initial profiling survey and were assigned three targeted habit change suggestions (tips). After each month, participants were asked to complete a follow-up survey and then receive new suggestions for the subsequent month. Results: In terms of overall attrition, 75% (1549/2053) of participants who completed the intake survey never returned to follow up. Overall mean weight loss among returning participants was 0.4% of initial weight (P=.019). Participants who stayed in the program at least three calendar months and completed at least two follow-up surveys (38%, 189/504) lost on average 1.8 lbs (1.0%) of their initial weight over the course of the program (P=.009). Furthermore, participants who reported consistent adherence (25+ days/month) to the suggested changes reported an average monthly weight loss of 2.0 lbs (P<.001). Weight loss was less for those who discontinued after 1-2 months or who did not adhere to the suggested changes. Participants who reported having lost weight reported higher monthly adherence to suggestions (mean 14.9 days, SD 7.92) than participants who maintained (mean 12.4 days, SD 7.63) or gained weight (mean 12.0 days, SD 7.50; F=14.17, P<.001). Common reported barriers for changes included personally unsuitable or inapplicable suggestions, forgetting or being too busy to implement changes, unusual circumstances, and emotional eating. Conclusions: Because the bulk of the free and commercially available online diet and nutritional tools conduct no evaluation research, it is difficult to determine which aspects of a program are successful and what are reasonable expectations of results. The results of this study suggest that online interventions based on small changes have the potential to gradually lead to clinically significant weight loss, but high attrition from publically available or “free” programs still remains a challenge. Adherence to and effectiveness of small habit changes may be improved through further tailoring to individual circumstances and psychological needs. %M 23246736 %R 10.2196/jmir.2218 %U http://www.jmir.org/2012/6/e168/ %U https://doi.org/10.2196/jmir.2218 %U http://www.ncbi.nlm.nih.gov/pubmed/23246736 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 6 %P e179 %T Differences in Reach and Attrition Between Web-Based and Print-Delivered Tailored Interventions Among Adults over 50 Years of Age: Clustered Randomized Trial %A Peels,Denise Astrid %A Bolman,Catherine %A Golsteijn,Rianne Henrica Johanna %A De Vries,Hein %A Mudde,Aart Nicolaas %A van Stralen,Maartje Marieke %A Lechner,Lilian %+ Open University of The Netherlands, Department of Psychology, PO Box 2960, Heerlen, 6401 DL, Netherlands, 31 455762296, denise.peels@ou.nl %K Web-based %K print-delivered %K physical activity %K older adults %K response %K reach %K adoption %K attrition %K dropout %K tailored advice %D 2012 %7 17.12.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: The Internet has the potential to provide large populations with individual health promotion advice at a relatively low cost. Despite the high rates of Internet access, actual reach by Web-based interventions is often disappointingly low, and differences in use between demographic subgroups are present. Furthermore, Web-based interventions often have to deal with high rates of attrition. Objective: This study aims to assess user characteristics related to participation and attrition when comparing Web-based and print-delivered tailored interventions containing similar content and thereby to provide recommendations in choosing the appropriate delivery mode for a particular target audience. Methods: We studied the distribution of a Web-based and a print-delivered version of the Active Plus intervention in a clustered randomized controlled trial (RCT). Participants were recruited via direct mailing within the participating Municipal Health Council regions and randomized to the printed or Web-based intervention by their region. Based on the answers given in a prior assessment, participants received tailored advice on 3 occasions: (1) within 2 weeks after the baseline, (2) 2 months after the baseline, and (3) within 4 months after the baseline (based on a second assessment at 3 months). The baseline (printed or Web-based) results were analyzed using ANOVA and chi-square tests to establish the differences in user characteristics between both intervention groups. We used logistic regression analyses to study the interaction between the user characteristics and the delivery mode in the prediction of dropout rate within the intervention period. Results: The printed intervention resulted in a higher participation rate (19%) than the Web-based intervention (12%). Participants of the Web-based intervention were significantly younger (P<.001), more often men (P=.01), had a higher body mass index (BMI) (P=.001) and a lower intention to be physically active (P=.03) than participants of the printed intervention. The dropout rate was significantly higher in the Web-based intervention group (53%) compared to the print-delivered intervention (39%, P<.001). A low intention to be physically active was a strong predictor for dropout within both delivery modes (P<.001). The difference in dropout rate between the Web-based and the printed intervention was not explained by user characteristics. Conclusions: The reach of the same tailored physical activity (PA) intervention in a printed or Web-based delivery mode differed between sociodemographic subgroups of participants over 50 years of age. Although the reach of the Web-based intervention is lower, Web-based interventions can be a good channel to reach high-risk populations (lower PA intention and higher BMI). While the dropout rate was significantly higher in the Web-based intervention group, no specific user characteristics explained the difference in dropout rates between the delivery modes. More research is needed to determine what caused the high rate of dropout in the Web-based intervention. Trial Registration: Dutch Trial Register (NTR): 2297: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2297 (Archived by WebCite at http://www.webcitation.org/65TkwoESp). %M 23246790 %R 10.2196/jmir.2229 %U http://www.jmir.org/2012/6/e179/ %U https://doi.org/10.2196/jmir.2229 %U http://www.ncbi.nlm.nih.gov/pubmed/23246790 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 6 %P e177 %T Web-Based Nursing Intervention for Self-Management of Pain After Cardiac Surgery: Pilot Randomized Controlled Trial %A Martorella,Géraldine %A Côté,José %A Racine,Mélanie %A Choinière,Manon %+ Faculty of Nursing, University of Montreal, CP 6128, succursale Centre-Ville, Montreal, QC, H3C3J7, Canada, 1 514 343 6111 ext 1000, geraldine.martorella@umontreal.ca %K postoperative pain %K cardiac surgery %K patient education %K Internet %K pilot study %K randomized controlled trial %D 2012 %7 14.12.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Most adults undergoing cardiac surgery suffer from moderate to severe pain for up to 6 days after surgery. Individual barriers and attitudes regarding pain and its relief make patients reluctant to report their pain and ask for analgesic medication, which results in inadequate pain management. More innovative educational interventions for postoperative pain relief are needed. We developed a Web-based nursing intervention to influence patient’s involvement in postoperative pain management. The intervention (SOULAGE-TAVIE) includes a preoperative 30-minute Web-based session and 2 brief face-to-face postoperative booster sessions. The Web application generates reflective activities and tailored educational messages according to patients’ beliefs and attitudes. The messages are transmitted through videos of a virtual nurse, animations, stories, and texts. Objective: The aim of this single-blinded pilot randomized trial was to investigate the preliminary effects of a virtual nursing intervention (SOULAGE-TAVIE) to improve pain relief in patients undergoing cardiac surgery. Methods: Participants (N = 60) were adults scheduled for their first cardiac surgery. They were randomly assigned to the experimental group using SOULAGE-TAVIE (n = 30) or the control group using usual care, including an educational pamphlet and postoperative follow-up (n = 30). Data were collected through questionnaires at the time of admission and from day 1 to day 7 after surgery with the help of a blinded research assistant. Outcomes were pain intensity, pain interference with daily activities, patients’ pain barriers, tendency to catastrophize in face of pain, and analgesic consumption. Results: The two groups were comparable at baseline across all demographic measures. Results revealed that patients in the experimental group did not experience less intense pain, but they reported significantly less pain interference when breathing/coughing (P = .04). A severe pain interference with breathing/coughing (pain ranked ≥ 7/10) was reported on day 3 after surgery by 15% of the patients in the experimental group (4/27), as compared to 44% (7/16) in the control group. On day 7 after surgery, participants in the experimental group also exhibited fewer pain-related barriers as measured by the Barriers Questionnaire-II (mean 10.6, SD 8.3) than patients in the control group (mean 15.8, SD 7.3, P = .02). No difference was found for pain catastrophizing. However, in both groups, means revealed a lower tendency to catastrophize pain before surgery as measured by the Pain Catastrophizing Scale (control group mean 1.04, SD 0.74; experimental group mean 1.10, SD 0.95) and after surgery (control group mean score 1.19, SD 0.94; experimental group mean score 1.08, SD 0.99). Finally, the experimental group consumed more opioid medication (mean 31.2 mg, SD 23.2) than the control group (mean 18.8 mg, SD 15.3, P  = .001). Conclusions: This pilot study provides promising results to support the benefits of this new Web-tailored approach that can increase accessibility to health education and promote pain relief without generating more costs. Trial Registration: Clinicaltrials.gov NCT01084018; http://www.clinicaltrials.gov/ct2/show/NCT01084018 (Archived by WebCite® at http://www.webcitation.org/6CoTBkIoT) %M 23241361 %R 10.2196/jmir.2070 %U http://www.jmir.org/2012/6/e177/ %U https://doi.org/10.2196/jmir.2070 %U http://www.ncbi.nlm.nih.gov/pubmed/23241361 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 6 %P e173 %T Features Predicting Weight Loss in Overweight or Obese Participants in a Web-Based Intervention: Randomized Trial %A Brindal,Emily %A Freyne,Jill %A Saunders,Ian %A Berkovsky,Shlomo %A Smith,Greg %A Noakes,Manny %+ CSIRO, Food & Nutritional Sciences, GPO box 10041, Adelaide, 5000, Australia, 61 883050633, emily.brindal@csiro.au %K Internet %K obesity %K dietetics %D 2012 %7 12.12.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Obesity remains a serious issue in many countries. Web-based programs offer good potential for delivery of weight loss programs. Yet, many Internet-delivered weight loss studies include support from medical or nutritional experts, and relatively little is known about purely web-based weight loss programs. Objective: To determine whether supportive features and personalization in a 12-week web-based lifestyle intervention with no in-person professional contact affect retention and weight loss. Methods: We assessed the effect of different features of a web-based weight loss intervention using a 12-week repeated-measures randomized parallel design. We developed 7 sites representing 3 functional groups. A national mass media promotion was used to attract overweight/obese Australian adults (based on body mass index [BMI] calculated from self-reported heights and weights). Eligible respondents (n = 8112) were randomly allocated to one of 3 functional groups: information-based (n = 183), supportive (n = 3994), or personalized-supportive (n = 3935). Both supportive sites included tools, such as a weight tracker, meal planner, and social networking platform. The personalized-supportive site included a meal planner that offered recommendations that were personalized using an algorithm based on a user’s preferences for certain foods. Dietary and activity information were constant across sites, based on an existing and tested 12-week weight loss program (the Total Wellbeing Diet). Before and/or after the intervention, participants completed demographic (including self-reported weight), behavioral, and evaluation questionnaires online. Usage of the website and features was objectively recorded. All screening and data collection procedures were performed online with no face-to-face contact. Results: Across all 3 groups, attrition was high at around 40% in the first week and 20% of the remaining participants each week. Retention was higher for the supportive sites compared to the information-based site only at week 12 (P = .01). The average number of days that each site was used varied significantly (P = .02) and was higher for the supportive site at 5.96 (SD 11.36) and personalized-supportive site at 5.50 (SD 10.35), relative to the information-based site at 3.43 (SD 4.28). In total, 435 participants provided a valid final weight at the 12-week follow-up. Intention-to-treat analyses (using multiple imputations) revealed that there were no statistically significant differences in weight loss between sites (P = .42). On average, participants lost 2.76% (SE 0.32%) of their initial body weight, with 23.7% (SE 3.7%) losing 5% or more of their initial weight. Within supportive conditions, the level of use of the online weight tracker was predictive of weight loss (model estimate = 0.34, P < .001). Age (model estimate = 0.04, P < .001) and initial BMI (model estimate = -0.03, P < .002) were associated with frequency of use of the weight tracker. Conclusions: Relative to a static control, inclusion of social networking features and personalized meal planning recommendations in a web-based weight loss program did not demonstrate additive effects for user weight loss or retention. These features did, however, increase the average number of days that a user engaged with the system. For users of the supportive websites, greater use of the weight tracker tool was associated with greater weight loss. %M 23234759 %R 10.2196/jmir.2156 %U http://www.jmir.org/2012/6/e173/ %U https://doi.org/10.2196/jmir.2156 %U http://www.ncbi.nlm.nih.gov/pubmed/23234759 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 6 %P e171 %T Impact of Interactive Web-Based Education With Mobile and Email-Based Support of General Practitioners on Treatment and Referral Patterns of Patients with Atopic Dermatitis: Randomized Controlled Trial %A Schopf,Thomas %A Flytkjær,Vibeke %+ Norwegian Centre for Integrated Care and Telemedicine, University Hospital of North-Norway, P.O. Box 35, Tromsø, 9038, Norway, 47 91527503, Thomas.Roger.Schopf@telemed.no %K Atopic dermatitis %K Internet %K continuing education %D 2012 %7 05.12.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: The effects of various educational strategies have been examined in continuing medical education. Web-based learning has emerged as an alternative to ordinary classroom lessons. Objective: To investigate whether an interactive Web-based course including personal guidance via email or cellular phone texting may be used to improve practice behavior of general practitioners in the management of atopic dermatitis. Methods: General practitioners from all over Norway were eligible for this randomized controlled educational trial. During a period of 6 months, doctors in the intervention group were offered the opportunity to participate in a Web-based course on the management of atopic dermatitis. This was combined with guidance via email or multimedia messaging service (MMS) through mobile phones from a dermatologist. In the control group there was no education or guidance. Main outcome measures were the duration of topical steroid treatment prescribed to patients with atopic dermatitis (primary outcome), number of treatment modalities, and number of referred patients. Results: We enrolled 46 physicians: 24 doctors were allocated to the intervention group and 22 doctors to the control group. They reported a total of 190 patient treatments. There were no statistically significant differences in the duration of topical steroid treatment or number of treatment modalities between the groups. The lack of effect on the primary outcome may be due to attrition as 54% (13/24) of the participants did not complete the course. 42% (10/24) of physicians sent at least one educational request via email or MMS. While 11% (8/73) of treatment reports in the intervention group were referred to a health care specialist (eg, dermatologist or pediatrician), 30% (21/71) of treatment reports in the control group did so. This difference in the number of referrals was significant (P = .03). Conclusions: A Web-based educational intervention aimed at general practitioners combined with personal support can reduce the number of atopic dermatitis patient referrals to specialists. %M 23249479 %R 10.2196/jmir.2359 %U http://www.jmir.org/2012/6/e171/ %U https://doi.org/10.2196/jmir.2359 %U http://www.ncbi.nlm.nih.gov/pubmed/23249479 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 6 %P e163 %T The Computer-Assisted Brief Intervention for Tobacco (CABIT) Program: A Pilot Study %A Boudreaux,Edwin D %A Bedek,Kristyna L %A Byrne,Nelson J %A Baumann,Brigitte M %A Lord,Sherrill A %A Grissom,Grant %+ University of Massachusetts Medical School, Emergency Medicine, LA-189, 55 Lake Avenue North, Worcester, MA, 01655, United States, 1 508 334 3817, Edwin.Boudreaux@umassmed.edu %K technology %K tobacco use cessation %K smoking cessation %K referrals %D 2012 %7 03.12.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Health care providers do not routinely carry out brief counseling for tobacco cessation despite the evidence for its effectiveness. For this intervention to be routinely used, it must be brief, be convenient, require little investment of resources, require little specialized training, and be perceived as efficacious by providers. Technological advances hold much potential for addressing the barriers preventing the integration of brief interventions for tobacco cessation into the health care setting. Objective: This paper describes the development and initial evaluation of the Computer-Assisted Brief Intervention for Tobacco (CABIT) program, a web-based, multimedia tobacco intervention for use in opportunistic settings. Methods: The CABIT uses a self-administered, computerized assessment to produce personalized health care provider and patient reports, and cue a stage-matched video intervention. Respondents interested in changing their tobacco use are offered a faxed referral to a “best matched” tobacco treatment provider (ie, dynamic referral). During 2008, the CABIT program was evaluated in an emergency department, an employee assistance program, and a tobacco dependence program in New Jersey. Participants and health care providers completed semistructured interviews and satisfaction ratings of the assessment, reports, video intervention, and referrals using a 5-point scale. Results: Mean patient satisfaction scores (n = 67) for all domains ranged from 4.00 (Good) to 5.00 (Excellent; Mean = 4.48). Health care providers completed satisfaction forms for 39 patients. Of these 39 patients, 34 (87%) received tobacco resources and referrals they would not have received under standard care. Of the 45 participants offered a dynamic referral, 28 (62%) accepted. Conclusions: The CABIT program provided a user-friendly, desirable service for tobacco users and their health care providers. Further development and clinical trial testing is warranted to establish its effectiveness in promoting treatment engagement and tobacco cessation. %M 23208070 %R 10.2196/jmir.2074 %U http://www.jmir.org/2012/6/e163/ %U https://doi.org/10.2196/jmir.2074 %U http://www.ncbi.nlm.nih.gov/pubmed/23208070 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 6 %P e158 %T Improving Diabetes Management With a Patient Portal: Qualitative Study of a Diabetes Self-Management Portal %A Urowitz,Sara %A Wiljer,David %A Dupak,Kourtney %A Kuehner,Zachary %A Leonard,Kevin %A Lovrics,Emily %A Picton,Peter %A Seto,Emily %A Cafazzo,Joe %+ ELLICSR: Health, Wellness & Cancer Survivorship Centre, University Health Network, Toronto General Hospital, BCS021 Clinical Services Building, 200 Elizabeth St, Toronto, ON, M5G 2M9, Canada, 1 416 581 8616, sara.urowitz@rmp.uhn.on.ca %K Diabetes Mellitus Type 2 %K self care %K self management %K online %K internet %K online management portal %K patient portal %K patient-physician interaction %D 2012 %7 30.11.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Effective management and care of diabetes is crucial to reducing associated risks such as heart disease and kidney failure. With increasing access and use of the Internet, online chronic disease management is being explored as a means of providing patients with support and the necessary tools to monitor and manage their disease. Objective: The objective of our study was to evaluate the experience of patients and providers using an online diabetes management portal for patients. Methods: Participants were recruited from a large sample population of 887 for a follow-up questionnaire to be completed after 6 months of using the patient portal. Participants were presented with the option to participate in an additional interview and, if the participant agreed, a time and date was scheduled for the interview. A 5-item, open-ended questionnaire was used to capture providers' opinions of the patient portal. Providers included general practitioners (GPs), nurses, nurse practitioners (NPs), dieticians, diabetes educators (DECs), and other clinical staff. Results: A total of 854 patients were consented for the questionnaire. Seventeen (8 male, 9 female) patients agreed to participate in a telephone interview. Sixty-four health care providers completed the five open-ended questions; however, an average of 48.2 responses were recorded per question. Four major themes were identified and will be discussed in this paper. These themes have been classified as: facilitators of disease management, barriers to portal use, patient-provider communication and relationship, and recommendations for portal improvements. Conclusions: This qualitative study shows that online chronic disease management portals increase patient access to information and engagement in their health care, but improvements in the portal itself may improve usability and reduce attrition. Furthermore, this study identifies a grey area that exists in the roles that GPs and AHPs should play in the facilitation of online disease management. %M 23195925 %R 10.2196/jmir.2265 %U http://www.jmir.org/2012/6/e158/ %U https://doi.org/10.2196/jmir.2265 %U http://www.ncbi.nlm.nih.gov/pubmed/23195925 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 6 %P e166 %T Web-Based Cognitive Behavioral Self-Help Intervention to Reduce Cocaine Consumption in Problematic Cocaine Users: Randomized Controlled Trial %A Schaub,Michael %A Sullivan,Robin %A Haug,Severin %A Stark,Lars %+ Research Institute for Public Health and Addiction, associated to Zurich University, Konradstreet 32, Zurich, , Switzerland, 41 44 448 11 65, michael.schaub@isgf.uzh.ch %K Cocaine %K Cognitive Behavioral Therapy %K Internet %K Randomized Controlled Trial %D 2012 %7 28.11.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based self-help programs that reduce problematic substance use are able to reach hidden consumer groups in the general population. These programs are characterized by their low treatment threshold and nonrestrictive intervention settings. They are also cost effective, making them of interest to both low-income and high-income industrialized countries with ever-increasing health costs. Objective: To test the feasibility and effectiveness of an anonymous, fully automated, Web-based self-help intervention as an alternative to outpatient treatment services for cocaine users. Methods: A total of 196 cocaine-using participants were recruited through various online and offline media for a randomized controlled trial. Participants in the intervention group received interactive cognitive behavioral modules and a consumption diary to reduce cocaine use, whereas participants in the control group received online psychoeducative information modules. Web-based follow-up assessments were conducted after 4 weeks, 6 weeks, and 6 months. Treatment retention was examined and compared between the intervention and control groups. Severity of cocaine dependence was the main outcome measure. Secondary outcomes were cocaine craving, depression symptoms, and alcohol and other substance use. Results: This Web-based intervention attracted older and more educated participants than existing outpatient treatment programs for which cocaine is the primary substance of abuse. Participants in the intervention group showed greater treatment retention compared with the control group (P = .04). Low response rates at the follow-up assessments restricted the explanatory power of the analyses. At the follow-up assessments, the severity of cocaine dependence did not differ between the intervention and control groups (P = .75). Furthermore, there were no differences in cocaine craving, depression, or alcohol and other substance use. Using the consumption diaries, the average number of cocaine-free days per week did not change significantly, whereas the weekly quantity of cocaine used decreased equally in both groups (P = .009). Conclusions: For cocaine users with low dependence severity, a fully automated Web-based cognitive behavioral self-help intervention is a feasible alternative with limited effectiveness in outpatient treatment services. However, this type of intervention may attract specific user groups that are rarely reached by existing outpatient treatment and may help them to control their cocaine consumption anonymously. Trial Registration: ISRCTN93702927; http://www.controlled-trials.com/ISRCTN93702927 (Archived by WebCite at http://www.webcitation.org/6CTMM10MR) %M 23192752 %R 10.2196/jmir.2244 %U http://www.jmir.org/2012/6/e166/ %U https://doi.org/10.2196/jmir.2244 %U http://www.ncbi.nlm.nih.gov/pubmed/23192752 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 6 %P e157 %T How Should Debriefing Be Undertaken in Web-Based Studies? Findings From a Randomized Controlled Trial %A McCambridge,Jim %A Kypri,Kypros %A Wilson,Amanda %+ Department of Social & Environmental Health Research, Faculty of Public Health & Policy, LSHTM, London, LSHTM, 15-17 Tavistock Place, London, WC1H 9HS, United Kingdom, 44 20 7927 2945, Jim.McCambridge@lshtm.ac.uk %K ethics %K debriefing %K deception %K online %K web-based %K randomised controlled trial %K methodology %D 2012 %7 16.11.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet research may raise older ethical issues in new forms or pose new issues. It has been recommended that debriefing information online be kept very short, with further information including study results made available if requested by participants. There are no empirical studies that compare possible alternative methods of debriefing in online studies. Objective: To undertake a randomized controlled trial evaluating how to implement the recommended approach by assessing the effects of two different approaches on accessing of additional information. Methods: All 11,943 participants in the Effects of Study Design and Allocation (ESDA) study, which employed deception, were randomly assigned to one of two methods of debriefing: Group A received the debriefing information in the body of an email with links to protocol and results pages; Group B was presented with these links after clicking on an initial link in the body of the email to view the debriefing information on a website. Outcomes assessed were the proportions clicking on the links to the protocol and results summary and the time spent on these pages by those accessing them. Results: The group who were presented with no debriefing information in the body of the email and went to a website for this information (Group B) were approximately twice as likely to subsequently access the protocol and the results summary. These differences between the two groups were highly statistically significant. Although these differences are clear, the overall proportions accessing such information were low, and there were no differences in mean time spent reading these pages. Only one quarter of Group B actually accessed debriefing information. Conclusions: In circumstances where the uptake of fuller information on study design, methods, and findings is deemed important, debriefing information may be better provided via a link and not included in the body of an email. Doing so may, however, reduce the extent of receiving any debriefing information at all. There is a wider need for high quality empirical studies to inform ethical evaluations. Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12610000846022 (http://www.anzctr.org.au/) %M 23160103 %R 10.2196/jmir.2186 %U http://www.jmir.org/2012/6/e157/ %U https://doi.org/10.2196/jmir.2186 %U http://www.ncbi.nlm.nih.gov/pubmed/23160103 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 6 %P e152 %T Persuasive System Design Does Matter: A Systematic Review of Adherence to Web-Based Interventions %A Kelders,Saskia M %A Kok,Robin N %A Ossebaard,Hans C %A Van Gemert-Pijnen,Julia EWC %+ Center for eHealth Research and Disease Management, Department of Psychology, Health and Technology, University of Twente, PO Box 217, Enschede, 7500 AE, Netherlands, 31 651070689, s.m.kelders@utwente.nl %K Systematic review %K web-based interventions %K adherence %K attrition %K persuasive technology %K behavior change %D 2012 %7 14.11.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Although web-based interventions for promoting health and health-related behavior can be effective, poor adherence is a common issue that needs to be addressed. Technology as a means to communicate the content in web-based interventions has been neglected in research. Indeed, technology is often seen as a black-box, a mere tool that has no effect or value and serves only as a vehicle to deliver intervention content. In this paper we examine technology from a holistic perspective. We see it as a vital and inseparable aspect of web-based interventions to help explain and understand adherence. Objective: This study aims to review the literature on web-based health interventions to investigate whether intervention characteristics and persuasive design affect adherence to a web-based intervention. Methods: We conducted a systematic review of studies into web-based health interventions. Per intervention, intervention characteristics, persuasive technology elements and adherence were coded. We performed a multiple regression analysis to investigate whether these variables could predict adherence. Results: We included 101 articles on 83 interventions. The typical web-based intervention is meant to be used once a week, is modular in set-up, is updated once a week, lasts for 10 weeks, includes interaction with the system and a counselor and peers on the web, includes some persuasive technology elements, and about 50% of the participants adhere to the intervention. Regarding persuasive technology, we see that primary task support elements are most commonly employed (mean 2.9 out of a possible 7.0). Dialogue support and social support are less commonly employed (mean 1.5 and 1.2 out of a possible 7.0, respectively). When comparing the interventions of the different health care areas, we find significant differences in intended usage (p = .004), setup (p < .001), updates (p < .001), frequency of interaction with a counselor (p < .001), the system (p = .003) and peers (p = .017), duration (F = 6.068, p = .004), adherence (F = 4.833, p = .010) and the number of primary task support elements (F = 5.631, p = .005). Our final regression model explained 55% of the variance in adherence. In this model, a RCT study as opposed to an observational study, increased interaction with a counselor, more frequent intended usage, more frequent updates and more extensive employment of dialogue support significantly predicted better adherence. Conclusions: Using intervention characteristics and persuasive technology elements, a substantial amount of variance in adherence can be explained. Although there are differences between health care areas on intervention characteristics, health care area per se does not predict adherence. Rather, the differences in technology and interaction predict adherence. The results of this study can be used to make an informed decision about how to design a web-based intervention to which patients are more likely to adhere. %M 23151820 %R 10.2196/jmir.2104 %U http://www.jmir.org/2012/6/e152/ %U https://doi.org/10.2196/jmir.2104 %U http://www.ncbi.nlm.nih.gov/pubmed/23151820 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 5 %P e142 %T Effectiveness of a Proactive Mail-Based Alcohol Internet Intervention for University Students: Dismantling the Assessment and Feedback Components in a Randomized Controlled Trial %A Bendtsen,Preben %A McCambridge,Jim %A Bendtsen,Marcus %A Karlsson,Nadine %A Nilsen,Per %+ Department of Medical and Health Sciences, Faculty of Health Sciences, Linköping University, Hälsouniversitetet, Kansliet, Linköping, SE-581 83, Sweden, 46 702324615, preben.bendtsen@liu.se %K Alcohol drinking %K Web-based intervention %K proactive intervention %K university students %D 2012 %7 31.10.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: University students in Sweden routinely receive proactive mail-based alcohol Internet interventions sent from student health services. This intervention provides personalized normative feedback on alcohol consumption with suggestions on how to decrease drinking. Earlier feasibility trials by our group and others have examined effectiveness in simple parallel-groups designs. Objective: To evaluate the effectiveness of electronic screening and brief intervention, using a randomized controlled trial design that takes account of baseline assessment reactivity (and other possible effects of the research process) due to the similarity between the intervention and assessment content. The design of the study allowed for exploration of the magnitude of the assessment effects per se. Methods: This trial used a dismantling design and randomly assigned 5227 students to 3 groups: (1) routine practice assessment and feedback, (2) assessment-only without feedback, and (3) neither assessment nor feedback. At baseline all participants were blinded to study participation, with no contact being made with group 3. We approached students 2 months later to participate in a cross-sectional alcohol survey. All interventions were fully automated and did not have any human involvement. All data used in the analysis were based on self-assessment using questionnaires. The participants were unaware that they were participating in a trial and thus were also blinded to which group they were randomly assigned. Results: Overall, 44.69% (n = 2336) of those targeted for study completed follow-up. Attrition was similar in groups 1 (697/1742, 40.01%) and 2 (737/1742, 42.31% retained) and lower in group 3 (902/1743, 51.75% retained). Intention-to-treat analyses among all participants regardless of their baseline drinking status revealed no differences between groups in all alcohol parameters at the 2-month follow-up. Per-protocol analyses of groups 1 and 2 among those who accepted the email intervention (36.2% of the students who were offered the intervention in group 1 and 37.3% of the students in group2 ) and who were risky drinkers at baseline (60.7% follow-up rate in group 1 and 63.5% in group 2) suggested possible small beneficial effects on weekly consumption attributable to feedback. Conclusions: This approach to outcome evaluation is highly conservative, and small benefits may follow the actual uptake of feedback intervention in students who are risky drinkers, the precise target group. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 24735383; http://www.controlled-trials.com/ISRCTN24735383 (Archived by WebCite at http://www.webcitation.org/6Awq7gjXG) %M 23113955 %R 10.2196/jmir.2062 %U http://www.jmir.org/2012/5/e142/ %U https://doi.org/10.2196/jmir.2062 %U http://www.ncbi.nlm.nih.gov/pubmed/23113955 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 5 %P e145 %T Effect of a Web-Based Intervention to Promote Physical Activity and Improve Health Among Physically Inactive Adults: A Population-Based Randomized Controlled Trial %A Hansen,Andreas Wolff %A Grønbæk,Morten %A Helge,Jørn Wulff %A Severin,Maria %A Curtis,Tine %A Tolstrup,Janne Schurmann %+ National Institute of Public Health, University of Southern Denmark, Oester Farimagsgade 5A, 2., Copenhagen, DK-1353, Denmark, 45 65507730, awh@niph.dk %K Intervention study: computer intervention %K health behavior %K primary prevention %K adults %D 2012 %7 30.10.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Many people in Western countries do not follow public health physical activity (PA) recommendations. Web-based interventions provide cost- and time-efficient means of delivering individually targeted lifestyle modification at a population level. Objective: To examine whether access to a website with individually tailored feedback and suggestions on how to increase PA led to improved PA, anthropometrics, and health measurements. Methods: Physically inactive adults (n = 12,287) participating in a nationwide eHealth survey and health examination in Denmark were randomly assigned to either an intervention (website) (n = 6055) or a no-intervention control group (n = 6232) in 2008. The intervention website was founded on the theories of stages of change and of planned behavior and, apart from a forum page where a physiotherapist answered questions about PA and training, was fully automated. After 3 and again after 6 months we emailed participants invitations to answer a Web-based follow-up questionnaire, which included the long version of the International Physical Activity Questionnaire. A subgroup of participants (n = 1190) were invited to a follow-up health examination at 3 months. Results: Less than 22.0% (694/3156) of the participants logged on to the website once and only 7.0% (222/3159) logged on frequently. We found no difference in PA level between the website and control groups at 3- and 6-month follow-ups. By dividing participants into three groups according to use of the intervention website, we found a significant difference in total and leisure-time PA in the website group. The follow-up health examination showed no significant reductions in body mass index, waist circumference, body fat percentage, and blood pressure, or improvements in arm strength and aerobic fitness in the website group. Conclusions: Based on our findings, we suggest that active users of a Web-based PA intervention can improve their level of PA. However, for unmotivated users, single-tailored feedback may be too brief. Future research should focus on developing more sophisticated interventions with the potential to reach both motivated and unmotivated sedentary individuals. Trial Registration: Clinicaltrials.gov NCT01295203; http://clinicaltrials.gov/ct2/show/NCT01295203 (Archived by WebCite at http://www.webcitation.org/6B7HDMqiQ) %M 23111127 %R 10.2196/jmir.2109 %U http://www.jmir.org/2012/5/e145/ %U https://doi.org/10.2196/jmir.2109 %U http://www.ncbi.nlm.nih.gov/pubmed/23111127 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 5 %P e140 %T Evaluation of End-User Satisfaction Among Employees Participating in a Web-based Health Risk Assessment With Tailored Feedback %A Vosbergen,Sandra %A Laan,Eva K %A Colkesen,Ersen B %A Niessen,Maurice AJ %A Kraaijenhagen,Roderik A %A Essink-Bot,Marie-Louise %A Peek,Niels %+ Academic Medical Center, Department of Medical Informatics, University of Amsterdam, P.O. Box 226600, Amsterdam, 1100DD, Netherlands, 31 20 5666179, s.vosbergen@amc.uva.nl %K eHealth %K satisfaction %K health risk assessment %K mixed methods %K health behavior %D 2012 %7 30.10.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Web technology is increasingly being used to provide individuals with health risk assessments (HRAs) with tailored feedback. End-user satisfaction is an important determinant of the potential impact of HRAs, as this influences program attrition and adherence to behavioral advice. Objective: The aim of this study was to evaluate end-user satisfaction with a web-based HRA with tailored feedback applied in worksite settings, using mixed (quantitative and qualitative) methods. Methods: Employees of seven companies in the Netherlands participated in a commercial, web-based, HRA with tailored feedback. The HRA consisted of four components: 1) a health and lifestyle assessment questionnaire, 2) a biometric evaluation, 3) a laboratory evaluation, and 4) tailored feedback consisting of a personal health risk profile and lifestyle behavior advice communicated through a web portal. HRA respondents received an evaluation questionnaire after six weeks. Satisfaction with different parts of the HRA was measured on 5-point Likert scales. A free-text field provided the opportunity to make additional comments. Results: In total, 2289 employees participated in the HRA program, of which 637 (27.8%) completed the evaluation questionnaire. Quantitative analysis showed that 85.6% of the respondents evaluated the overall HRA positively. The free-text field was filled in by 29.7 % of the respondents (189 out of 637), who made 315 separate remarks. Qualitative evaluation of these data showed that these respondents made critical remarks. Respondents felt restricted by the answer categories of the health and lifestyle assessment questionnaire, which resulted in the feeling that the corresponding feedback could be inadequate. Some respondents perceived the personal risk profile as unnecessarily alarming or suggested providing more explanations, reference values, and a justification of the behavioral advice given. Respondents also requested the opportunity to discuss the feedback with a health professional. Conclusions: Most people were satisfied with the web-based HRA with tailored feedback. Sources of dissatisfaction were limited opportunities for providing additional health information outside of the predefined health and lifestyle assessment questionnaire and insufficient transparency on the generation of the feedback. Information regarding the aim and content of the HRA should be clear and accurate to prevent unrealistic expectations among end-users. Involving trusted health professionals in the implementation of web-based HRAs may enhance the use of and confidence in the HRA. %M 23111097 %R 10.2196/jmir.2067 %U http://www.jmir.org/2012/5/e140/ %U https://doi.org/10.2196/jmir.2067 %U http://www.ncbi.nlm.nih.gov/pubmed/23111097 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 5 %P e134 %T Economic Evaluation of Internet-Based Interventions for Harmful Alcohol Use Alongside a Pragmatic Randomized Controlled Trial %A Blankers,Matthijs %A Nabitz,Udo %A Smit,Filip %A Koeter,Maarten WJ %A Schippers,Gerard M %+ Department Jellinek, Arkin Mental Health Care, PO Box 75848, Amsterdam, 1070 AV, Netherlands, 31 611785270, m.blankers@amc.uva.nl %K Cost-benefit analysis %K randomized controlled trial %K alcohol-induced disorders %K self-help %K computer-assisted therapy %D 2012 %7 29.10.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet interventions with and without therapist support have been found to be effective treatment options for harmful alcohol users. Internet-based therapy (IT) leads to larger and longer-lasting positive effects than Internet-based self-help (IS), but it is also more costly to provide. Objective: To evaluate the cost effectiveness and cost utility of Internet-based interventions for harmful use of alcohol through the assessment of the incremental cost effectiveness of IT compared with IS. Methods: This study was performed in a substance abuse treatment center in Amsterdam, the Netherlands. We collected data over the years 2008–2009. A total of 136 participants were included, 70 (51%) were female, and mean age was 41.5 (SD 9.83) years. Reported alcohol consumption and Alcohol Use Disorders Identification Test (AUDIT) scores indicated harmful drinking behavior at baseline. We collected self-reported outcome data prospectively at baseline and 6 months after randomization. Cost data were extracted from the treatment center’s cost records, and sex- and age-specific mean productivity cost data for the Netherlands. Results: The median incremental cost-effectiveness ratio was estimated at €3683 per additional treatment responder and €14,710 per quality-adjusted life-year (QALY) gained. At a willingness to pay €20,000 for 1 additional QALY, IT had a 60% likelihood of being more cost effective than IS. Sensitivity analyses attested to the robustness of the findings. Conclusions: IT offers better value for money than IS and might therefore be considered as a treatment option, either as first-line treatment in a matched-care approach or as a second-line treatment in the context of a stepped-care approach. Trial Registration: Netherlands Trial Register NTR-TC1155; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1155 (Archived by WebCite at http://www.webcitation.org/6AqnV4eTU) %M 23103771 %R 10.2196/jmir.2052 %U http://www.jmir.org/2012/5/e134/ %U https://doi.org/10.2196/jmir.2052 %U http://www.ncbi.nlm.nih.gov/pubmed/23103771 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 5 %P e124 %T eHealth Program to Empower Patients in Returning to Normal Activities and Work After Gynecological Surgery: Intervention Mapping as a Useful Method for Development %A Vonk Noordegraaf,Antonie %A Huirne,Judith A.F %A Pittens,Carina A %A van Mechelen,Willem %A Broerse,Jacqueline E.W %A Brölmann,Hans A.M %A Anema,Johannes R %+ VU University Medical Center, Department of Obstetrics and Gynaecology, De Boelelaan 1117, 1081 HV Amsterdam, Amsterdam, , Netherlands, 31 204446065, t.vonknoordegraaf@vumc.nl %K eHealth intervention %K interactive website %K Internet %K patient empowerment %K intervention mapping %K gynecological surgery %K hysterectomy %K laparoscopic adnexal surgery %K return to work %D 2012 %7 19.10.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Full recovery after gynecological surgery takes much longer than expected regardless of surgical technique or the level of invasiveness. After discharge, detailed convalescence recommendations are not provided to patients typically, and postoperative care is fragmented, poorly coordinated, and given only on demand. For patients, this contributes to irrational beliefs and avoidance of resumption of activities and can result in a prolonged sick leave. Objective: To develop an eHealth intervention that empowers gynecological patients during the perioperative period to obtain timely return to work (RTW) and prevent work disability. Methods: The intervention mapping (IM) protocol was used to develop the eHealth intervention. A literature search about behavioral and environmental conditions of prolonged sick leave and delayed RTW in patients was performed. Patients’ needs, attitudes, and beliefs regarding postoperative recovery and resumption of work were identified through focus group discussions. Additionally, a literature search was performed to obtain determinants, methods, and strategies for the development of a suitable interactive eHealth intervention to empower patients to return to normal activities after gynecological surgery, including work. Finally, the eHealth intervention was evaluated by focus group participants, medical doctors, and eHealth specialists through questionnaires. Results: Twenty-one patients participated in the focus group discussions. Sufficient, uniform, and tailored information regarding surgical procedures, complications, and resumption of activities and work were considered most essential. Knowing who to contact in case of mental or physical complaints, and counseling and tools for work reintegration were also considered important. Finally, opportunities to exchange experiences with other patients were a major issue. Considering the determinants of the Attitude–Social influence–self-Efficacy (ASE) model, various strategies based on a combination of theory and evidence were used, resulting in an eHealth intervention with different interactive functionalities including tailored convalescence recommendations and a video to communicate the most common pitfalls during the perioperative period to patients and employers. Fifteen patients in the focus groups, 11 physicians, and 3 eHealth specialists suggested points for improvement to optimize the usability of the eHealth intervention and judged it an approachable, appropriate, and attractive eHealth intervention to empower gynecological patients. Conclusions: The IM protocol was a useful method to develop an eHealth intervention based on both theory and evidence. All patients and stakeholders judged the eHealth intervention to be a promising tool to empower gynecological patients during the perioperative period and to help them to return to normal activities and work. %M 23086834 %R 10.2196/jmir.1915 %U http://www.jmir.org/2012/5/e124/ %U https://doi.org/10.2196/jmir.1915 %U http://www.ncbi.nlm.nih.gov/pubmed/23086834 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 5 %P e127 %T What Young People Want From a Sexual Health Website: Design and Development of Sexunzipped %A McCarthy,Ona %A Carswell,Kenneth %A Murray,Elizabeth %A Free,Caroline %A Stevenson,Fiona %A Bailey,Julia V %+ e-Health Unit, Research Department of Primary Care & Population Health, University College London, Upper 3rd Floor, Royal Free Hospital, Rowland Hill Street, London, NW3 2PF, United Kingdom, 44 (0)20 7794 0500, omccarthy@tccr.org.uk %K Sex education %K adolescents %K young adults %K qualitative research %D 2012 %7 12.10.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Sexual health education in the United Kingdom is of variable quality, typically focusing on the biological aspects of sex rather than on communication, relationships, and sexual pleasure. The Internet offers a unique opportunity to provide sexual health education to young people, since they can be difficult to engage but frequently use the Internet as a health information resource. Objectives: To explore through qualitative research young people’s views on what elements of a sexual health website would be appealing and engaging, and their views on the content, design, and interactive features of the Sexunzipped intervention website. Methods: We recruited 67 young people aged 16–22 years in London, UK. We held 21 focus groups and 6 one-to-one interviews to establish sexual health priorities, views on website look and feel, and what features of a sexual heath website would attract and engage them. Two researchers facilitated the focus groups, using a semistructured topic guide to lead the discussions and asking open questions to elicit a range of views. The discussions and interviews were audio recorded and detailed notes were made on key topics from the audio recording. Young people’s views influenced design templates for the content and interactive features of Sexunzipped. Results: Young people particularly wanted straightforward information on sexual pleasure, sexually transmitted infections and pregnancy, how to communicate with partners, how to develop skills in giving pleasure, and emotions involved in sex and relationships. Focus group participants wanted social interaction with other young people online and wanted to see themselves reflected in some way such as through images or videos. Conclusions: While it is challenging to meet all of young people’s technological and design requirements, consultation with the target audience is valuable and necessary in developing an online sexual health intervention. Young people are willing to talk about sensitive issues, enjoy the discussions, and can offer key insights that influence intervention development. %M 23060424 %R 10.2196/jmir.2116 %U http://www.jmir.org/2012/5/e127/ %U https://doi.org/10.2196/jmir.2116 %U http://www.ncbi.nlm.nih.gov/pubmed/23060424 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 4 %P e109 %T Preventing Smoking Relapse via Web-Based Computer-Tailored Feedback: A Randomized Controlled Trial %A Elfeddali,Iman %A Bolman,Catherine %A Candel,Math J.J.M %A Wiers,Reinout W %A de Vries,Hein %+ Department of Health Promotion, School for Public Health and Primary Care (Caphri), Maastricht University, PO Box 616, Maastricht, 6200 MD, Netherlands, 31 433882436, iman.elfeddali@maastrichtuniversity.nl %K Smoking relapse prevention %K computer tailoring %K multiple tailoring %K planning strategies %D 2012 %7 20.08.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based computer-tailored approaches have the potential to be successful in supporting smoking cessation. However, the potential effects of such approaches for relapse prevention and the value of incorporating action planning strategies to effectively prevent smoking relapse have not been fully explored. The Stay Quit for You (SQ4U) study compared two Web-based computer-tailored smoking relapse prevention programs with different types of planning strategies versus a control group. Objectives: To assess the efficacy of two Web-based computer-tailored programs in preventing smoking relapse compared with a control group. The action planning (AP) program provided tailored feedback at baseline and invited respondents to do 6 preparatory and coping planning assignments (the first 3 assignments prior to quit date and the final 3 assignments after quit date). The action planning plus (AP+) program was an extended version of the AP program that also provided tailored feedback at 11 time points after the quit attempt. Respondents in the control group only filled out questionnaires. The study also assessed possible dose–response relationships between abstinence and adherence to the programs. Methods: The study was a randomized controlled trial with three conditions: the control group, the AP program, and the AP+ program. Respondents were daily smokers (N = 2031), aged 18 to 65 years, who were motivated and willing to quit smoking within 1 month. The primary outcome was self-reported continued abstinence 12 months after baseline. Logistic regression analyses were conducted using three samples: (1) all respondents as randomly assigned, (2) a modified sample that excluded respondents who did not make a quit attempt in conformance with the program protocol, and (3) a minimum dose sample that also excluded respondents who did not adhere to at least one of the intervention elements. Observed case analyses and conservative analyses were conducted. Results: In the observed case analysis of the randomized sample, abstinence rates were 22% (45/202) in the control group versus 33% (63/190) in the AP program and 31% (53/174) in the AP+ program. The AP program (odds ratio 1.95, P = .005) and the AP+ program (odds ratio 1.61, P = .049) were significantly more effective than the control condition. Abstinence rates and effects differed per sample. Finally, the results suggest a dose–response relationship between abstinence and the number of program elements completed by the respondents. Conclusion: Despite the differences in results caused by the variation in our analysis approaches, we can conclude that Web-based computer-tailored programs combined with planning strategy assignments and feedback after the quit attempt can be effective in preventing relapse 12 months after baseline. However, adherence to the intervention seems critical for effectiveness. Finally, our results also suggest that more research is needed to assess the optimum intervention dose. Trial Registration: Dutch Trial Register: NTR1892; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1892 (Archived by WebCite at http://www.webcitation.org/693S6uuPM) %M 22903145 %R 10.2196/jmir.2057 %U http://www.jmir.org/2012/4/e109/ %U https://doi.org/10.2196/jmir.2057 %U http://www.ncbi.nlm.nih.gov/pubmed/22903145 %0 Journal Article %@ 1923-2195 %I Gunther Eysenbach %V 1 %N 2 %P e3 %T Web-Based Interventions for Behavior Change and Self-Management: Potential, Pitfalls, and Progress %A Murray,Elizabeth %+ e-Health Unit, Research Department of Primary Care and Population Health, University College London, Upper Floor 3, Royal Free Hospital, Rowland Hill Street, London, NW3 2 PF, United Kingdom, 44 (0)20 7794 0500 ext 36747, elizabeth.murray@ucl.ac.uk %K Internet %K self-care %K eHealth %K health behavior %D 2012 %7 14.08.2012 %9 Viewpoint %J Med 2.0 %G English %X The potential advantages of using the Internet to deliver self-care and behavior-change programs are well recognized. An aging population combined with the increasing prevalence of long-term conditions and more effective medical interventions place financial strain on all health care systems. Web-based interventions have the potential to combine the tailored approach of face-to-face interventions with the scalability of public health interventions that have low marginal costs per additional user. From a patient perspective, Web-based interventions can be highly attractive because they are convenient, easily accessible, and can maintain anonymity/privacy. Recognition of this potential has led to research in developing and evaluating Web-based interventions for self-management of long-term conditions and behavior change. Numerous systematic reviews have confirmed the effectiveness of some Web-based interventions, but a number of unanswered questions still remain. This paper reviews the progress made in developing and evaluating Web-based interventions and considers three challenging areas: equity, effectiveness, and implementation. The impact of Web-based interventions on health inequalities remains unclear. Although some have argued that such interventions can increase access to underserved communities, there is evidence to suggest that reliance on Web-based interventions may exacerbate health inequalities by excluding those on the “wrong” side of the digital divide. Although most systematic reviews have found a positive effect on outcomes of interest, effect sizes tend to be small and not all interventions are successful. Further work is needed to determine why some interventions work and others do not. This includes considering the “active ingredients” or mechanism of action of these complex interventions and the context in which they are used. Are there certain demographic, psychological, or clinical factors that promote or inhibit success? Are some behaviors or some clinical problems more amenable to change by computer-based interventions? Equally problematic is the issue of implementation and integration of such programs into routine clinical practice. Many eHealth projects end when the research is concluded and fail to become part of mainstream clinical care. One way of addressing these challenges is to apply the Medical Research Council framework for developing, evaluating, and implementing complex interventions. This includes having a strong theoretical foundation, developing a proposed mechanism or pathway of action, ensuring that the evaluation adequately reflects this proposed pathway, and considering implementation from the beginning of the development process. %M 25075231 %R 10.2196/med20.1741 %U http://www.medicine20.com/2012/2/e3/ %U https://doi.org/10.2196/med20.1741 %U http://www.ncbi.nlm.nih.gov/pubmed/25075231 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 4 %P e107 %T Comparison of Two Internet-Based Interventions for Problem Drinkers: Randomized Controlled Trial %A Cunningham,John Alastair %+ Social and Epidemiological Research, Centre for Addiction and Mental Health, 33 Russell St, Toronto, ON, M5S 2S1, Canada, 1 416 535 8501 ext 4682, john_cunningham@camh.net %K Randomized controlled trial %K problem drinking %K alcohol abuse %K Internet-based intervention %K eHealth %K brief intervention %D 2012 %7 01.08.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Alcohol problems are a serious public health concern, and few problem drinkers ever seek treatment. The Internet is one means of promoting access to care, but more research is needed to test the best types of interventions to employ. Evaluation of Internet-based interventions that contain a variety of research-validated cognitive-behavioral tools, which have been shown to be helpful to those with more severe alcohol concerns, should be a priority. Objective: To evaluate whether providing access to an extended Internet intervention for alcohol problems offers additional benefits in promoting reductions in alcohol consumption compared with a brief Internet intervention. The hypothesis for the current trial was that respondents who were provided with access to an extended Internet intervention (the Alcohol Help Center [AHC]) would display significantly improved drinking outcomes at 6-month follow-up, compared with respondents who were provided with access to a brief Internet intervention (the Check Your Drinking [CYD] screener). Methods: A single-blinded randomized controlled trial with a 6-month follow-up. A general population sample of problem drinkers was recruited through newspaper advertisements in a large metropolitan city. Baseline and follow-up data were collected by postal mail. Results: A volunteer sample of problem drinkers of legal drinking age with home access to the Internet were recruited for the trial. Of 239 potential respondents recruited in 2010, 170 met inclusion criteria (average age 45 years; 101/170, 59.4% male; average Alcohol Use Disorders Identification Test [AUDIT] score of 22). Follow-up rates were 90.0% (153/170) with no adverse effects of the interventions reported. A repeated-measures multivariate analysis of variance of the outcome measures using an intent-to-treat approach found a significantly greater reduction in amount of drinking among participants provided access to the AHC than among participants provided access to the CYD (P = .046). Conclusions: The provision of the AHC gave additional benefit in the short term to problem drinkers over that seen from the research-validated CYD, indicating the benefits of promoting access to these interventions as one means of helping people with problem drinking concerns. Trial Registration: ClinicalTrials.gov NCT01114919; http://clinicaltrials.gov/ct2/show/NCT01114919 (Archived by WebCite at http://www.webcitation.org/68t1dCkRZ) %M 22954459 %R 10.2196/jmir.2090 %U http://www.jmir.org/2012/4/e107/ %U https://doi.org/10.2196/jmir.2090 %U http://www.ncbi.nlm.nih.gov/pubmed/22954459 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 4 %P e98 %T Internet-Based Brief Personalized Feedback Intervention in a Non-Treatment-Seeking Population of Adult Heavy Drinkers: A Randomized Controlled Trial %A Hansen,Anders Blædel Gottlieb %A Becker,Ulrik %A Nielsen,Anette Søgaard %A Grønbæk,Morten %A Tolstrup,Janne Schurmann %A Thygesen,Lau Caspar %+ National Institute of Public Health, Faculty of Health Sciences, University of Southern Denmark, Øster Farimagsgade 5 A, 2nd floor, Copenhagen, 1353, Denmark, 45 6550 7777 ext 7729, ago@niph.dk %K Internet-based personalized feedback %K normative feedback %K alcohol %K heavy drinking %K adult %K Internet-based personalized brief advice, brief intervention %D 2012 %7 30.07.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-based interventions for heavy drinkers show promising results, but existing research is characterized by few studies in nonstudent adult populations and few comparisons with appropriate control groups. Objective: To test whether a fully automated Internet-based brief personalized feedback intervention and a fully automated Internet-based personalized brief advice intervention in a non-treatment-seeking population of heavy drinkers would result in a reduced alcohol intake. Methods: We conducted a 3-arm parallel randomized controlled trial in a general population-based sample of heavy drinkers. The 54,157 participants (median age of 58 years) were screened for heavy drinking. Of the 3418 participants who had a weekly alcohol consumption above 14 drinks for women and 21 drinks for men, 1380 (619 women) consented to take part in the trial and were randomly assigned to an Internet-based brief personalized feedback intervention group (normative feedback, n = 476), an Internet-based personalized brief advice intervention group (n = 450), or a nonintervention control group (n = 454). Follow-up after 6 and 12 months included 871 and 1064 participants, respectively, of all groups combined. The outcome measure was self-reported weekly alcohol consumption. We analyzed the data according to the intention-to-treat principle. To examine changes over time and to account for the multiple time measurements, we used a multilevel linear mixed model. To take attrition into account, we used multiple imputation to address missing data. Results: The intervention effect of the Internet-based brief personalized feedback intervention, determined as the mean additional difference in changes in alcohol consumption in the Internet-based brief personalized feedback intervention compared with the control group, was –1.8 drinks/week after 6 months and –1.4 drinks/week after 12 months; these effects were nonsignificant (95% confidence interval –4.0 to 0.3 at 6 months, –3.4 to 0.6 at 12 months). The intervention effect of the Internet-based personalized brief advice intervention was –0.5 drinks/week after 6 months and –1.2 drinks/week after 12 months; these effects were nonsignificant (95% confidence interval –2.7 to 1.6 at 6 months, –3.3 to 0.9 at 12 months). Conclusions: In this randomized controlled trial we found no evidence that an Internet-based brief personalized feedback intervention was effective in reducing drinking in an adult population of heavy drinkers. Trial registration: ClinicalTrials.gov NCT00751985; http://clinicaltrials.gov/ct2/show/NCT00751985 (Archived by WebCite at http://www.webcitation.org/68WCRLyaP) %M 22846542 %R 10.2196/jmir.1883 %U http://www.jmir.org/2012/4/e98/ %U https://doi.org/10.2196/jmir.1883 %U http://www.ncbi.nlm.nih.gov/pubmed/22846542 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 4 %P e96 %T Use of Email and Telephone Prompts to Increase Self-Monitoring in a Web-Based Intervention: Randomized Controlled Trial %A Greaney,Mary L %A Sprunck-Harrild,Kim %A Bennett,Gary G %A Puleo,Elaine %A Haines,Jess %A Viswanath,K Vish %A Emmons,Karen M %+ Center for Community-Based Research, Dana-Farber Cancer Institute, 450 Brookline Ave, LW664, Boston, MA, 02215, United States, 1 617 582 7940, mary_greaney@dfci.harvard.edu %K Web-based health promotion intervention %K self-monitoring %K prompts %D 2012 %7 27.07.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Self-monitoring is a key behavior change mechanism associated with sustained health behavior change. Although Web-based interventions can offer user-friendly approaches for self-monitoring, engagement with these tools is suboptimal. Increased use could encourage, promote, and sustain behavior change. Objective: To determine whether email prompts or email plus telephone prompts increase self-monitoring of behaviors on a website created for a multiple cancer risk reduction program. Methods: We recruited and enrolled participants (N = 100) in a Web-based intervention during a primary care well visit at an urban primary care health center. The frequency of daily self-monitoring was tracked on the study website. Participants who tracked at least one behavior 3 or more times during week 1 were classified as meeting the tracking threshold and were assigned to the observation-only group (OO, n = 14). This group was followed but did not receive prompts. Participants who did not meet the threshold during week 1 were randomly assigned to one of 2 prompting conditions: automated assistance (AA, n = 36) or automated assistance + calls (AAC, n = 50). During prompting periods (weeks 2–3), participants in the AA and AAC conditions received daily automated emails that encouraged tracking and two tailored self-monitoring reports (end of week 2, end of week 3) that provided feedback on tracking frequency. Individuals in the AAC condition also received two technical assistance calls from trained study staff. Frequency of self-monitoring was tracked from week 2 through week 17. Results: Self-monitoring rates increased in both intervention conditions during prompting and declined when prompting ceased. Over the 16 weeks of observation, there was a significant between-group difference in the percentage who met the self-monitoring threshold each week, with better maintenance in the AAC than in the AA condition (P < .001). Self-monitoring rates were greater in the OO group than in either the AA or AAC condition (P < .001). Conclusions: Prompting can increase self-monitoring rates. The decrease in self-monitoring after the promoting period suggests that additional reminder prompts would be useful. The use of technical assistance calls appeared to have a greater effect in promoting self-monitoring at a therapeutic threshold than email reminders and the tailored self-monitoring reports alone. Trial Registration: ClinicalTrials.gov NCT01415492; http://clinicaltrials.gov/ct2/show/NCT01415492 (Archived by WebCite at http://www.webcitation.org/68LOXOMe2) %M 22842775 %R 10.2196/jmir.1981 %U http://www.jmir.org/2012/4/e96/ %U https://doi.org/10.2196/jmir.1981 %U http://www.ncbi.nlm.nih.gov/pubmed/22842775 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 4 %P e101 %T The Effects of Combining Web-Based eHealth With Telephone Nurse Case Management for Pediatric Asthma Control: A Randomized Controlled Trial %A Gustafson,David %A Wise,Meg %A Bhattacharya,Abhik %A Pulvermacher,Alice %A Shanovich,Kathleen %A Phillips,Brenda %A Lehman,Erik %A Chinchilli,Vernon %A Hawkins,Robert %A Kim,Jee-Seon %+ Center for Health Enhancement Systems Studies, University of Wisconsin-Madison, 1513 University Avenue, Room 4109, Madison, WI, 53706, United States, 1 608 263 4882, dhgustaf@wisc.edu %K Asthma %K asthma information %K childhood disease %K case management %K patient education %K eHealth %K social support %D 2012 %7 26.07.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Asthma is the most common pediatric illness in the United States, burdening low-income and minority families disproportionately and contributing to high health care costs. Clinic-based asthma education and telephone case management have had mixed results on asthma control, as have eHealth programs and online games. Objectives: To test the effects of (1) CHESS+CM, a system for parents and children ages 4–12 years with poorly controlled asthma, on asthma control and medication adherence, and (2) competence, self-efficacy, and social support as mediators. CHESS+CM included a fully automated eHealth component (Comprehensive Health Enhancement Support System [CHESS]) plus monthly nurse case management (CM) via phone. CHESS, based on self-determination theory, was designed to improve competence, social support, and intrinsic motivation of parents and children. Methods: We identified eligible parent–child dyads from files of managed care organizations in Madison and Milwaukee, Wisconsin, USA, sent them recruitment letters, and randomly assigned them (unblinded) to a control group of treatment as usual plus asthma information or to CHESS+CM. Asthma control was measured by the Asthma Control Questionnaire (ACQ) and self-reported symptom-free days. Medication adherence was a composite of pharmacy refill data and medication taking. Social support, information competence, and self-efficacy were self-assessed in questionnaires. All data were collected at 0, 3, 6, 9, and 12 months. Asthma diaries kept during a 3-week run-in period before randomization provided baseline data. Results: Of 305 parent–child dyads enrolled, 301 were randomly assigned, 153 to the control group and 148 to CHESS+CM. Most parents were female (283/301, 94%), African American (150/301, 49.8%), and had a low income as indicated by child’s Medicaid status (154/301, 51.2%); 146 (48.5%) were single and 96 of 301 (31.9%) had a high school education or less. Completion rates were 127 of 153 control group dyads (83.0%) and 132 of 148 CHESS+CM group dyads (89.2%). CHESS+CM group children had significantly better asthma control on the ACQ (d = –0.31, 95% confidence limits [CL] –0.56, –0.06, P = .011), but not as measured by symptom-free days (d = 0.18, 95% CL –0.88, 1.60, P = 1.00). The composite adherence scores did not differ significantly between groups (d = 1.48%, 95% CL –8.15, 11.11, P = .76). Social support was a significant mediator for CHESS+CM’s effect on asthma control (alpha = .200, P = .01; beta = .210, P = .03). Self-efficacy was not significant (alpha = .080, P = .14; beta = .476, P = .01); neither was information competence (alpha = .079, P = .09; beta = .063, P = .64). Conclusions: Integrating telephone case management with eHealth benefited pediatric asthma control, though not medication adherence. Improved methods of measuring medication adherence are needed. Social support appears to be more effective than information in improving pediatric asthma control. Trial Registration: Clinicaltrials.gov NCT00214383; http://clinicaltrials.gov/ct2/show/NCT00214383 (Archived by WebCite at http://www.webcitation.org/68OVwqMPz) %M 22835804 %R 10.2196/jmir.1964 %U http://www.jmir.org/2012/4/e101/ %U https://doi.org/10.2196/jmir.1964 %U http://www.ncbi.nlm.nih.gov/pubmed/22835804 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 4 %P e105 %T Effects of Functional Interactivity on Patients’ Knowledge, Empowerment, and Health Outcomes: An Experimental Model-Driven Evaluation of a Web-Based Intervention %A Camerini,Luca %A Schulz,Peter Johannes %+ Institute of Communication and Health, Faculty of Communication Sciences, Università della Svizzera italiana, via G. Buffi 13, Lugano, 6900, Switzerland, 41 0586664821, lukame@gmail.com %K Interactivity %K health literacy %K patient empowerment %K fibromyalgia %K Internet intervention %D 2012 %7 18.07.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: The effectiveness of eHealth interventions in terms of reach and outcomes is now well documented. However, there is a need to understand not only whether eHealth interventions work, but also what kind of functions and mechanisms enhance their effectiveness. The present investigation contributes to tackling these challenges by investigating the role played by functional interactivity on patients’ knowledge, empowerment, and health outcomes. Objectives: To test whether health knowledge and empowerment mediate a possible relationship between the availability of interactive features on an eHealth application and individuals’ health outcomes. We present an empirical, model-driven evaluation of the effects of functional interactivity implemented in an eHealth application, based on a brief theoretical review of the constructs of interactivity, health knowledge, empowerment, and health outcomes. We merged these constructs into a theoretical model of interactivity effects that we tested on an eHealth application for patients with fibromyalgia syndrome (FMS). Methods: This study used a pretest–posttest experimental design. We recruited 165 patients and randomly assigned them to three study groups, corresponding to different levels of functional interactivity. Eligibility to participate in the study required that patients (1) be fluent in Italian, (2) have access to the Internet, (3) report confidence in how to use a computer, and (4) have received a diagnosis of FMS from a doctor. We used structural equation modeling techniques to analyze changes between the pretest and the posttest results. Results: The main finding was that functional interactivity had no impact on empowerment dimensions, nor direct observable effects on knowledge. However, knowledge positively affected health outcomes (b = –.12, P = .02), as did the empowerment dimensions of meaning (b = –.49, P < .001) and impact (b = –.25, P < .001). Conclusion: The theoretical model was partially confirmed, but only as far as the effects of knowledge and empowerment were concerned. The differential effect of interactive functions was by far weaker than expected. The strong impact of knowledge and empowerment on health outcomes suggests that these constructs should be targeted and enhanced by eHealth applications. %M 22810046 %R 10.2196/jmir.1953 %U http://www.jmir.org/2012/4/e105/ %U https://doi.org/10.2196/jmir.1953 %U http://www.ncbi.nlm.nih.gov/pubmed/22810046 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 4 %P e99 %T Public Health Interventions: Reaching Latino Adolescents via Short Message Service and Social Media %A Vyas,Amita N %A Landry,Megan %A Schnider,Marisa %A Rojas,Angela M %A Wood,Susan F %+ Maternal and Child Health, Department of Prevention and Community Health, George Washington University, Suite 700, 2175 K Street NW, Washington, DC, 20007, United States, 1 2029943695, avyas@gwu.edu %K Public health interventions %K SMS %K short message service %K social media %K health behavior %K Latinos %K adolescents %D 2012 %7 12.07.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Adolescents are substantial users of short message service (SMS) and social media. The public health community now has more opportunities to reach this population with positive youth development and health messages through these media. Latinos are a growing and youthful population with significant health risks and needs. This population may benefit from SMS and social media health interventions. Objective: To examine (1) SMS and social media utilization and behavior among Latino youth, and (2) how SMS and social media can be effectively used as a component of public health interventions focused on decreasing sexual risk taking among Latino youth. Methods: A mixed-methods approach, using both quantitative survey data and qualitative interview data, was used to provide a robust understanding of SMS and social media use and behavior for public health interventions. We recruited 428 ninth and tenth grade, self-identifying Latino adolescents to participate in a quantitative survey. Additionally, we conducted five key informant interviews with staff and 15 youth. Results: We found that 90.8% (355/391) of respondents had access to a mobile phone either through having their own or through borrowing or sharing one. Of those who had access to a mobile phone, 94.1% (334/355) used SMS, with 41.1% (113/275) sending and receiving more than 100 text messages per day. Of 395 respondents, 384 (97.2%) had at least one social media account, and the mean number of accounts was 3.0 (range 0–8). A total of 75.8% (291/384) of adolescents logged in to their account daily. Of those with a social media account, 89.1% (342/384) had a Facebook account. Youth who took the survey in English were significantly more likely than those who took it in Spanish to have access to a mobile phone (χ21 = 5.3; 93.3% vs 86.3%; P = .02); to be high-volume texters (χ22 = 16.8; 49.4% vs 25.3%; P < .001); to use the Internet daily (χ21 = 5.0; 76.6% vs 66.0%; P = .03); to have a Facebook account (χ21 = 9.9; 90.9% vs 79.7%; P = .002); and to have a greater mean number of social media accounts (t387 = 7.9; 3.41 vs 2.07; P < .001). Conclusions: SMS and social media are pervasive among Latino youth. Program staff and youth perceive these as credible and essential methods of communication in the context of public health programs. Public health interventions must continue to innovate and maximize new ways to reach young people to reinforce public health messages and education. %M 22789678 %R 10.2196/jmir.2178 %U http://www.jmir.org/2012/4/e99/ %U https://doi.org/10.2196/jmir.2178 %U http://www.ncbi.nlm.nih.gov/pubmed/22789678 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 3 %P e92 %T Beyond Efficacy: The Depth and Diversity of Current Internet Interventions %A Christensen,Helen %A Calear,Alison L %A Andersson,Gerhard %A Thorndike,Frances P %A Tait,Robert J %+ Black Dog Institute, University of New South Wales, Hospital Road, Randwick, Sydney, NSW, 2031, Australia, 61 2 9382 9288, h.christensen@unsw.edu.au %D 2012 %7 29.06.2012 %9 Editorial %J J Med Internet Res %G English %X %M 22743601 %R 10.2196/jmir.2206 %U http://www.jmir.org/2012/3/e92/ %U https://doi.org/10.2196/jmir.2206 %U http://www.ncbi.nlm.nih.gov/pubmed/22743601 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 3 %P e80 %T Active Assistance Technology for Health-Related Behavior Change: An Interdisciplinary Review %A Kennedy,Catriona M %A Powell,John %A Payne,Thomas H %A Ainsworth,John %A Boyd,Alan %A Buchan,Iain %+ School of Community-Based Medicine, University of Manchester, 1.311 Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, United Kingdom, 44 161 275 5205, Buchan@manchester.ac.uk %K Behavior change %K consumer health informatics %K health communication %K health promotion %K personalization %D 2012 %7 14.06.2012 %9 Review %J J Med Internet Res %G English %X Background: Information technology can help individuals to change their health behaviors. This is due to its potential for dynamic and unbiased information processing enabling users to monitor their own progress and be informed about risks and opportunities specific to evolving contexts and motivations. However, in many behavior change interventions, information technology is underused by treating it as a passive medium focused on efficient transmission of information and a positive user experience. Objective: To conduct an interdisciplinary literature review to determine the extent to which the active technological capabilities of dynamic and adaptive information processing are being applied in behavior change interventions and to identify their role in these interventions. Methods: We defined key categories of active technology such as semantic information processing, pattern recognition, and adaptation. We conducted the literature search using keywords derived from the categories and included studies that indicated a significant role for an active technology in health-related behavior change. In the data extraction, we looked specifically for the following technology roles: (1) dynamic adaptive tailoring of messages depending on context, (2) interactive education, (3) support for client self-monitoring of behavior change progress, and (4) novel ways in which interventions are grounded in behavior change theories using active technology. Results: The search returned 228 potentially relevant articles, of which 41 satisfied the inclusion criteria. We found that significant research was focused on dialog systems, embodied conversational agents, and activity recognition. The most covered health topic was physical activity. The majority of the studies were early-stage research. Only 6 were randomized controlled trials, of which 4 were positive for behavior change and 5 were positive for acceptability. Empathy and relational behavior were significant research themes in dialog systems for behavior change, with many pilot studies showing a preference for those features. We found few studies that focused on interactive education (3 studies) and self-monitoring (2 studies). Some recent research is emerging in dynamic tailoring (15 studies) and theoretically grounded ontologies for automated semantic processing (4 studies). Conclusions: The potential capabilities and risks of active assistance technologies are not being fully explored in most current behavior change research. Designers of health behavior interventions need to consider the relevant informatics methods and algorithms more fully. There is also a need to analyze the possibilities that can result from interaction between different technology components. This requires deep interdisciplinary collaboration, for example, between health psychology, computer science, health informatics, cognitive science, and educational methodology. %M 22698679 %R 10.2196/jmir.1893 %U http://www.jmir.org/2012/3/e80/ %U https://doi.org/10.2196/jmir.1893 %U http://www.ncbi.nlm.nih.gov/pubmed/22698679 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 3 %P e82 %T Effectiveness of a Web-Based Multiple Tailored Smoking Cessation Program: A Randomized Controlled Trial Among Dutch Adult Smokers %A Smit,Eline Suzanne %A de Vries,Hein %A Hoving,Ciska %+ Department of Health Promotion, Maastricht University, PO Box 616, Maastricht, 6200 MD, Netherlands, 31 433882397, es.smit@maastrichtuniversity.nl %K Smoking cessation %K Web-based intervention %K computer tailoring %K iterative feedback %K intervention %K randomized controlled trial %D 2012 %7 11.06.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Distributing a multiple computer-tailored smoking cessation intervention through the Internet has several advantages for both provider and receiver. Most important, a large audience of smokers can be reached while a highly individualized and personal form of feedback can be maintained. However, such a smoking cessation program has yet to be developed and implemented in the Netherlands. Objective: To investigate the effects of a Web-based multiple computer-tailored smoking cessation program on smoking cessation outcomes in a sample of Dutch adult smokers. Methods: Smokers were recruited from December 2009 to June 2010 by advertising our study in the mass media and on the Internet. Those interested and motivated to quit smoking within 6 months (N = 1123) were randomly assigned to either the experimental (n = 552) or control group (n = 571). Respondents in the experimental group received the fully automated Web-based smoking cessation program, while respondents in the control group received no intervention. After 6 weeks and after 6 months, we assessed the effect of the intervention on self-reported 24-hour point prevalence abstinence, 7-day point prevalence abstinence, and prolonged abstinence using logistic regression analyses. Results: Of the 1123 respondents, 449 (40.0%) completed the 6-week follow-up questionnaire and 291 (25.9%) completed the 6-month follow-up questionnaire. We used a negative scenario to replace missing values. That is, we considered respondents lost to follow-up to still be smoking. The computer-tailored program appeared to have significantly increased 24-hour point prevalence abstinence (odds ratio [OR] 1.85, 95% confidence interval [CI] 1.30–2.65), 7-day point prevalence abstinence (OR 2.17, 95% CI 1.44–3.27), and prolonged abstinence (OR 1.99, 95% CI 1.28–3.09) rates reported after 6 weeks. After 6 months, however, no intervention effects could be identified. Results from complete-case analyses were similar. Conclusions: The results presented suggest that the Web-based computer-tailored smoking cessation program had a significant effect on abstinence reported after a 6-week period. At the 6-month follow-up, however, no intervention effects could be identified. This might be explained by the replacement of missing values on the primary outcome measures due to attrition using a negative scenario. While results were similar when using a less conservative scenario (ie, complete-case analyses), the results should still be interpreted with caution. Further research should aim at identifying strategies that will prevent high attrition in the first place and, subsequently, to identify the best strategies for dealing with missing data when studies have high attrition rates. Trial Registration: Dutch Trial Register NTR1351; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1351 (Archived by WebCite at http://www.webcitation.org/67egSTWrz) %M 22687887 %R 10.2196/jmir.1812 %U http://www.jmir.org/2012/3/e82/ %U https://doi.org/10.2196/jmir.1812 %U http://www.ncbi.nlm.nih.gov/pubmed/22687887 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 3 %P e86 %T Effectiveness of an Online Group Course for Depression in Adolescents and Young Adults: A Randomized Trial %A van der Zanden,Rianne %A Kramer,Jeannet %A Gerrits,Rob %A Cuijpers,Pim %+ Centre of Mental Health of Youth and Adolescents, Trimbos Institute, Da Costakade 45, Utrecht, 3500 AS Utrecht, Netherlands, 31 030 2971100, rzanden@trimbos.nl %K eHealth, health promotion %K depressive symptoms %K anxiety %K adolescents %K Internet %K randomized controlled trial %D 2012 %7 07.06.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression is a serious mental health problem, whose first onset is usually in adolescence. Online treatment may offer a solution for the current undertreatment of depression in youth. For adults with depressive symptoms, the effectiveness of Internet-based cognitive behavioral therapy has been demonstrated. This study is one of the first randomized controlled trials to investigate the effectiveness online depression treatment for young people with depressive complaints and the first to focus on an online group course. Objective: To evaluate and discuss the effectiveness of a guided Web-based group course called Grip op Je Dip (Master Your Mood [MYM]), designed for young people aged 16 to 25 years with depressive symptoms, in comparison with a wait-listed control group. Methods: We randomly assigned 244 young people with depressive symptoms to the online MYM course or to a waiting-list control condition. The primary outcome measure was treatment outcome after 3 months on the Center for Epidemiologic Studies Depression Scale. Secondary outcomes were anxiety (measured by the Hospital Anxiety and Depression Scale) and mastery (Mastery Scale). We studied the maintenance of effects in the MYM group 6 months after baseline. Missing data were imputed. Results: The MYM group (n = 121) showed significantly greater improvement in depressive symptoms at 3 months than the control group (n = 123) (t187 = 6.62, P < .001), with a large between-group effect size of d = 0.94 (95% confidence interval [CI] 0.64–1.23). The MYM group also showed greater improvement in anxiety (t187 = 3.80, P < .001, d = 0.49, 95% CI 0.24–0.75) and mastery (t187 = 3.36, P = .001, d = 0.44, 95% CI 0.19–0.70). At 12 weeks, 56% (68/121) of the participants in the MYM group and 20% (24/123) in the control group showed reliable and clinically significant change. This between-group difference was significant (χ21 = 35.0, P < .001) and yielded a number needed to treat of 2.7. Improvements in the MYM group were maintained at 6 months. A limitation is the infeasibility of comparing the 6-month outcomes of the MYM and control groups, as the controls had access to MYM after 3 months. Conclusions: The online group course MYM was effective in reducing depressive symptoms and anxiety and in increasing mastery in young people. These effects persisted in the MYM group at 6 months. Trial Registration: Nederlands Trial Register: NTR1694; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1694 (Archived by WebCite at http://www.webcitation.org/683SBoeGV) %M 22677437 %R 10.2196/jmir.2033 %U http://www.jmir.org/2012/3/e86/ %U https://doi.org/10.2196/jmir.2033 %U http://www.ncbi.nlm.nih.gov/pubmed/22677437 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 3 %P e81 %T Short-term Effects of a Smoking Prevention Website in American Indian Youth %A Bowen,Deborah J %A Henderson,Patricia Nez %A Harvill,Jessica %A Buchwald,Dedra %+ School of Public Health, Boston University, 801 Massachusetts Avenue, Boston, MA, 02118, United States, 1 617 638 5205, dbowen@bu.edu %K Smoking prevention %K Native American %K eHealth %K intervention %K cultural appropriateness %D 2012 %7 01.06.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: The rate of smoking commercial tobacco products among American Indian youth is double the rate for white youth. Interventions are needed to reduce this disparity. Objective: To test the feasibility of a Web-based intervention to influence attitudes toward and intentions about smoking cigarettes among American Indian youth who attended a Native summer camp in the Northern Plains. Methods: The study website, the SmokingZine, was originally developed and tested in Canadian youth, then adapted to be appropriate for American Indian youth. We conducted a randomized controlled trial to test the influence of exposure to the adapted SmokingZine website on smoking attitudes and behaviors among American Indian youth 12–18 years of age. Participants assigned to the intervention group were given access to the website for 1 hour per day during their camp experience and asked to sign in to the site and use it. Control group participants were not given access to the site. Results: A total of 52% of intervention youth signed in to the website at least once. Among nonsmokers, intentions to try a cigarette in the intervention group declined from 16% to 0%, and increased from 8% to 25% in the control group (P < .05). Compared with the control group, youth in the intervention group were more likely to help others quit (21 percentage point change in intervention versus no change in control; P < .05) and had less positive attitudes about the drug effects of smoking (–0.19 change in intervention versus 0.67 in control; P < .05). Conclusion: These data indicate that SmokingZine needs more long-term, rigorous investigation as a way to keep American Indian youth from becoming regular smokers. Because the intervention group could use computers only 1 hour per day, increasing access might result in more visits and a greater effect of the website on smoking behaviors. %M 22659390 %R 10.2196/jmir.1682 %U http://www.jmir.org/2012/3/e81/ %U https://doi.org/10.2196/jmir.1682 %U http://www.ncbi.nlm.nih.gov/pubmed/22659390 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 3 %P e71 %T Efficacy of a Computerized Simulation in Promoting Walking in Individuals With Diabetes %A Gibson,Bryan %A Marcus,Robin L %A Staggers,Nancy %A Jones,Jason %A Samore,Matthew %A Weir,Charlene %+ George E Whalen Salt Lake City Veterans Affairs Healthcare System, IDEAS center, 500 Foothill drive, Salt Lake City, UT, 84148, United States, 1 (801) 582 1565 ext 246, bryan.gibson@utah.edu %K Computer simulation %K type 2 diabetes mellitus %K physical activity %K blood glucose %D 2012 %7 10.05.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Regular walking is a recommended but underused self-management strategy for individuals with type 2 diabetes mellitus (T2DM). Objective: To test the impact of a simulation-based intervention on the beliefs, intentions, knowledge, and walking behavior of individuals with T2DM. We compared two versions of a brief narrated simulation. The experimental manipulation included two components: the presentation of the expected effect of walking on the glucose curve; and the completion of an action plan for walking over the next week. Primary hypotheses were (1) intervention participants’ walking (minutes/week) would increase more than control participants’ walking, and (2) change in outcome expectancies (beliefs) would be a function of the discrepancy between prior beliefs and those presented in the simulation. Secondary hypotheses were that, overall, behavioral intentions to walk in the coming week and diabetes-related knowledge would increase in both groups. Methods: Individuals were randomly assigned to condition. Preintervention measures included self-reported physical activity (International Physical Activity Questionnaire [IPAQ] 7-day), theory of planned behavior-related beliefs, and knowledge (Diabetes Knowledge Test). During the narrated simulation we measured individuals’ outcome expectancies regarding the effect of exercise on glucose with a novel drawing task. Postsimulation measures included theory of planned behavior beliefs, knowledge, and qualitative impressions of the narrated simulation. The IPAQ 7-day was readministered by phone 1 week later. We used a linear model that accounted for baseline walking to test the main hypothesis regarding walking. Discrepancy scores were calculated between the presented outcome and individuals’ prior expectations (measured by the drawing task). A linear model with an interaction between intervention status and the discrepancy score was used to test the hypothesis regarding change in outcome expectancy. Pre–post changes in intention and knowledge were tested using paired t tests. Results: Of 65 participants, 33 were in the intervention group and 32 in the control group. We excluded 2 participants from analysis due to being extreme outliers in baseline walking. After adjustment for baseline difference in age and intentions between groups, intervention participants increased walking by 61.0 minutes/week (SE 30.5, t58 = 1.9, P = .05) more than controls. The proposed interaction between the presented outcome and the individual’s prior beliefs was supported: after adjustment for baseline differences in age and intentions between groups, the coefficient for the interaction was –.25, (SE 0.07, t57 = –3.2, P < .01). On average participants in both groups improved significantly from baseline in intentions (mean difference 0.66, t62 = 4.5, P < .001) and knowledge (mean difference 0.38, t62 = 2.4, P = .02). Conclusions: This study suggests that a brief, Internet-ready, simulation-based intervention can improve knowledge, beliefs, intentions, and short-term behavior in individuals with T2DM. %M 22576226 %R 10.2196/jmir.1965 %U http://www.jmir.org/2012/3/e71/ %U https://doi.org/10.2196/jmir.1965 %U http://www.ncbi.nlm.nih.gov/pubmed/22576226 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 2 %P e48 %T Internet-Based Computer Tailored Feedback on Sunscreen Use %A de Vries,Hein %A Logister,Matti %A Krekels,Gertruud %A Klaasse,Frits %A Servranckx,Verina %A van Osch,Liesbeth %+ School for Public Health and Primary Care (CAPHRI), Department of Health Promotion, Maastricht University, P Debyeplein 1, PO Box 616, Maastricht, 6200 MD, Netherlands, 31 433882415, hein.devries@maastrichtuniversity.nl %K Health communication, Computer tailoring %K Web-based interventions, Internet %D 2012 %7 30.04.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Skin cancer incidence rates signify the need for effective programs for the prevention of skin cancer and for helping skin cancer patients. Internet and computer tailored (CT) technology fosters the development of highly individualized health communication messages. Yet, reactions to Internet CT programs may differ per level of involvement and education level and remain understudied. Objective: First, we identified perceptions concerning sunscreen use in Dutch adults and assessed differences in differences between the general public and skin cancer patients, and between low and high educated respondents. Second, we assessed program evaluations of these groups about a new Dutch CT Internet-based program promoting sunscreen use, and potential differences between groups Methods: A cross-sectional research design was used. In total, 387 respondents participated and filled out an online questionnaire based on the I-Change Model assessing socio-demographics, history of skin cancer, sunscreen use, and beliefs about sunscreen use. The responses were fed into a computer program that generated personal tailored feedback on screen; next we assessed their program evaluations Results: Of the 132 patients, 92 were female (69.7%) and 40 were male (30.3%). In the general population (N = 225), 139 (54.5%) respondents were female and 116 (45.5%) were male. Men (50.9 years) were 8 years older than women (43.1 years). Most patients were diagnosed with basal cell carcinoma (N = 65; 49.2%), followed by melanoma (N = 28; 21.2%) and squamous cell carcinoma (N = 10; 7.6%); 22% (N = 29) did not remember their skin cancer type. Patients had higher knowledge levels, felt significantly more at risk, were more convinced of the pros of sunscreen, experienced more social support to use sunscreen, had higher self-efficacy, and made more plans to use sunscreen than respondents without skin cancer (N=255; all P’s< .01). Low (N=196) educated respondents scored lower on knowledge (P<.003) but made more action plans (P<.03) than higher educated respondents (N=191). The CT feedback was evaluated positively by all respondents, and scored a 7.8 on a 10 point scale. Yet, patients evaluated the CT program slightly more (P<.05) positive (8.1) than non-patients. (7.6). Lower educated respondents were significantly (P<.05) more positive about the advantages of the program. Conclusions: First, involvement with skin cancer was reflected in more positive beliefs toward sunscreen use in patients in comparison with non-patients. Second, the CT Internet program was well accepted by both patients and non-patients, and low and high educated respondents, perhaps because higher educated respondents were more knowledgeable about sunscreen use and skin cancer. Third, a pro-active approach as conducted in our study is very well suited to reach various groups of people and is more likely to be successful than a reactive approach %M 22547528 %R 10.2196/jmir.1902 %U http://www.jmir.org/2012/2/e48/ %U https://doi.org/10.2196/jmir.1902 %U http://www.ncbi.nlm.nih.gov/pubmed/22547528 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 2 %P e59 %T Design of a Website on Nutrition and Physical Activity for Adolescents: Results From Formative Research %A Thompson,Debbe %A Cullen,Karen Weber %A Boushey,Carol %A Konzelmann,Karen %+ USDA/ARS Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine, 1100 Bates Street, Houston, TX, 77030, United States, 1 713 798 7076, dit@bcm.edu %K Internet %K intervention %K obesity prevention %K food %K physical activity %D 2012 %7 26.04.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Teens do not meet guidelines for healthy eating and physical activity. The Internet may be an effective method for delivering programs that help them adopt healthy behaviors. Objective: To collect information to design content and structure for a teen-friendly website promoting healthy eating and physical activity behaviors. Methods: Qualitative research, encompassing both focus group and interview techniques, were used to design the website. Participants were 12-17 year olds in Houston, Texas, and West Lafayette, Indiana. Results: A total of 133 participants took part in 26 focus groups while 15 participated in one-on-one interviews to provide guidance for the development of teen-friendly content and structure for an online behavior change program promoting healthy eating and physical activity to 12-17 year olds. The youth made suggestions to overcome common barriers to healthy eating and physical activity. Their feedback was used to develop “Teen Choice: Food & Fitness,” a 12-week online behavior change program, populated by 4 cartoon character role models. Conclusions: It is critical that members of the target audience be included in formative research to develop behavior change programs that are relevant, appealing, and address their needs and interests. %M 22538427 %R 10.2196/jmir.1889 %U http://www.jmir.org/2012/2/e59/ %U https://doi.org/10.2196/jmir.1889 %U http://www.ncbi.nlm.nih.gov/pubmed/22538427 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 2 %P e57 %T A 12-Week Commercial Web-Based Weight-Loss Program for Overweight and Obese Adults: Randomized Controlled Trial Comparing Basic Versus Enhanced Features %A Collins,Clare E %A Morgan,Philip J %A Jones,Penelope %A Fletcher,Kate %A Martin,Julia %A Aguiar,Elroy J %A Lucas,Ashlee %A Neve,Melinda J %A Callister,Robin %+ Nutrition and Dietetics, School of Health Sciences, Faculty of Health, The University of Newcastle, HA 12 Hunter Building, University Drive, Callaghan, NSW, 2308, Australia, 61 2 49215646, clare.collins@newcastle.edu.au %K Intervention %K weight loss %K Web-based intervention %K randomized controlled trial %K reducing diet %K eHealth %D 2012 %7 25.04.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: The development and use of Web-based programs for weight loss is increasing rapidly, yet they have rarely been evaluated using randomized controlled trials (RCTs). Interestingly, most people who attempt weight loss use commercially available programs, yet it is very uncommon for commercial programs to be evaluated independently or rigorously. Objective: To compare the efficacy of a standard commercial Web-based weight-loss program (basic) versus an enhanced version of this Web program that provided additional personalized e-feedback and contact from the provider (enhanced) versus a wait-list control group (control) on weight outcomes in overweight and obese adults. Methods: This purely Web-based trial using a closed online user group was an assessor-blinded RCT with participants randomly allocated to the basic or enhanced 12-week Web-based program, based on social cognitive theory, or the control, with body mass index (BMI) as the primary outcome. Results: We enrolled 309 adults (129/309, 41.8% male, BMI mean 32.3, SD 4 kg/m2) with 84.1% (260/309) retention at 12 weeks. Intention-to-treat analysis showed that both intervention groups reduced their BMI compared with the controls (basic: –0.72, SD 1.1 kg/m2, enhanced: –1.0, SD 1.4, control: 0.15, SD 0.82; P < .001) and lost significant weight (basic: –2.1, SD 3.3 kg, enhanced: –3.0, SD 4.1, control: 0.4, SD 2.3; P < .001) with changes in waist circumference (basic: –2.0, SD 3.5 cm, enhanced: –3.2, SD 4.7, control: 0.5, SD 3.0; P < .001) and waist-to-height ratio (basic: –0.01, SD 0.02, enhanced: –0.02, SD 0.03, control: 0.0, SD 0.02; P < .001), but no differences were observed between the basic and enhanced groups. The addition of personalized e-feedback and contact provided limited additional benefits compared with the basic program. Conclusions: A commercial Web-based weight-loss program can be efficacious across a range of weight-related outcomes and lifestyle behaviors and achieve clinically important weight loss. Although the provision of additional personalized feedback did not facilitate greater weight loss after 12 weeks, the impact of superior participant retention on longer-term outcomes requires further study. Further research is required to determine the optimal mix of program features that lead to the biggest treatment impact over time. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): 12610000197033; http://www.anzctr.org.au/trial_view.aspx?id=335159 (Archived by WebCite at http://www.webcitation.org/66Wq0Yb7U) %M 22555246 %R 10.2196/jmir.1980 %U http://www.jmir.org/2012/2/e57/ %U https://doi.org/10.2196/jmir.1980 %U http://www.ncbi.nlm.nih.gov/pubmed/22555246 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 2 %P e53 %T Web-Based, Computer-Tailored, Pedometer-Based Physical Activity Advice: Development, Dissemination Through General Practice, Acceptability, and Preliminary Efficacy in a Randomized Controlled Trial %A De Cocker,Katrien %A Spittaels,Heleen %A Cardon,Greet %A De Bourdeaudhuij,Ilse %A Vandelanotte,Corneel %+ Department of Movement and Sports Sciences, Ghent University, Watersportlaan 2, Ghent, B-9000, Belgium, 32 92646323, Katrien.DeCocker@ugent.be %K Physical activity intervention %K step counts %K computer tailoring %D 2012 %7 24.04.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Computer tailoring is a relatively innovative and promising physical activity intervention approach. However, few computer-tailored physical activity interventions in adults have provided feedback based on pedometer use. Objectives: To (1) describe the development of a Web-based, pedometer-based, computer-tailored step advice intervention, (2) report on the dissemination of this tool through general practice, (3) report on its perceived acceptability, and (4) evaluate the preliminary efficacy of this tool in comparison with a standard intervention. Methods: We recruited 92 participants through general practitioners and randomly assigned them to a standard condition (receiving a pedometer-only intervention, n = 47) and a tailored condition (receiving a pedometer plus newly developed, automated, computer-tailored step advice intervention, n = 45). Step counts, self-reported data obtained via telephone interview on physical activity, time spent sitting, and body mass index were assessed at baseline and postintervention. The present sample was mostly female (54/92, 59%), highly educated (59/92, 64%), employed (65/92, 71%), and in good health (62/92, 67%). Results: Recruitment through general practitioners was poor (n = 107, initial response rate 107/1737, 6.2%); however, the majority of participants (50/69, 73%) believed it is useful that general practitioners help patients find ways to increase physical activity. In the tailored condition, 30/43 (70%) participants requested the computer-tailored step advice and the majority found it understandable (21/21, 100%), credible (17/18, 94%), relevant (15/18, 83%), not too long (13/18, 72%), instructive (13/18, 72%), and encouraging to increase steps (16/24, 67%). Daily step counts increased from baseline (mean 9237, SD 3749 steps/day) to postintervention (mean 11,876, SD 4574 steps/day) in the total sample (change of 2639, 95% confidence interval 105–5172; F1 = 5.0, P = .04). No interaction or other time effects were found. Conclusions : The majority of participants in the tailored condition accepted the step advice and indicated it was useful. However, in this selected sample of adults, the tailored condition did not show superior effects compared with the standard condition. %M 22532102 %R 10.2196/jmir.1959 %U http://www.jmir.org/2012/2/e53/ %U https://doi.org/10.2196/jmir.1959 %U http://www.ncbi.nlm.nih.gov/pubmed/22532102 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 2 %P e44 %T Results from an Online Computer-Tailored Weight Management Intervention for Overweight Adults: Randomized Controlled Trial %A van Genugten,Lenneke %A van Empelen,Pepijn %A Boon,Brigitte %A Borsboom,Gerard %A Visscher,Tommy %A Oenema,Anke %+ Department of Public Health, Erasmus MC, Univserity Medical Center, PO Box 2040, Rotterdam, 3000 CA, Netherlands, 31 107043721, l.vangenugten@erasmusmc.nl %K Prevention %K Overweight %K Adults %K Randomized Controlled Trial %K Physical activity %K Dietary intake %K BMI %D 2012 %7 14.03.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Prevention of weight gain has been suggested as an important strategy in the prevention of obesity and people who are overweight are a specifically important group to target. Currently there is a lack of weight gain prevention interventions that can reach large numbers of people. Therefore, we developed an Internet-delivered, computer-tailored weight management intervention for overweight adults. The focus of the intervention was on making small (100 kcal per day), but sustained changes in dietary intake (DI) or physical activity (PA) behaviors in order to maintain current weight or achieve modest weight loss. Self-regulation theory was used as the basis of the intervention. Objective: This study aims to evaluate the efficacy of the computer-tailored intervention in weight-related anthropometric measures (Body Mass Index, skin folds and waist circumference) and energy balance-related behaviors (physical activity; intake of fat, snacks and sweetened drinks) in a randomized controlled trial. Methods: The tailored intervention (TI) was compared to a generic information website (GI). Participants were 539 overweight adults (mean age 47.8 years, mean Body Mass Index (BMI) 28.04, 30.9% male, 10.7% low educated) who where recruited among the general population and among employees from large companies by means of advertisements and flyers. Anthropometric measurements were measured by trained research assistants at baseline and 6-months post-intervention. DI and PA behaviors were assessed at baseline, 1-month and 6-month post-intervention, using self-reported questionnaires. Results: Repeated measurement analyses showed that BMI remained stable over time and that there were no statistically significant differences between the study groups (BMI: TI=28.09, GI=27.61, P=.09). Similar results were found for waist circumference and skin fold thickness. Amount of physical activity increased and intake of fat, snacks and sweetened drinks decreased during the course of the study, but there were no differences between the study groups (eg, fat intake: TI=15.4, GI=15.9, P=.74). The first module of the tailored intervention was visited by almost all participants, but only 15% completed all four modules of the tailored intervention, while 46% completed the three modules of the general information intervention. The tailored intervention was considered more personally relevant (TI=3.20, GI=2.83, P=.001), containing more new information (TI=3.11, GI=2.73, P=.003) and having longer texts (TI=3.20, GI=3.07, P=.01), while there were no group differences on other process measures such as attractiveness and comprehensibility of the information (eg, attractive design: TI=3.22, GI=3.16, P=.58). Conclusions: The online, computer-tailored weight management intervention resulted in changes in the desired direction, such as stabilization of weight and improvements in dietary intake, but the intervention was not more effective in preventing weight gain or modifying dietary and physical activity behaviors than generic information. A possible reason for the absence of intervention effects is sub-optimal use of the intervention and the self-regulation components. Further research is therefore needed to gain more insight into how the intervention and exposure to its contents can be improved. Trial Registration: NTR1862; http://apps.who.int/trialsearch/trial.aspx?trialid=NTR1862 %M 22417813 %R 10.2196/jmir.1901 %U http://www.jmir.org/2012/2/e44/ %U https://doi.org/10.2196/jmir.1901 %U http://www.ncbi.nlm.nih.gov/pubmed/22417813 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 2 %P e45 %T The Role of User Control in Adherence to and Knowledge Gained from a Website: Randomized Comparison Between a Tunneled Version and a Freedom-of-Choice Version %A Crutzen,Rik %A Cyr,Dianne %A de Vries,Nanne K %+ Department of Health Promotion, Maastricht University/CAPHRI, P.O. Box 616, Maastricht, 6200 MD, Netherlands, 31 433882828, rik.crutzen@maastrichtuniversity.nl %K website use %K user control %K user perceptions %K Internet %K interventions %D 2012 %7 09.03.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-delivered interventions can effectively change health risk behaviors and their determinants, but adherence to these interventions once they are accessed is very low. Therefore, it is relevant and necessary to systematically manipulate website characteristics to test their effect on website use. This study focuses on user control as a website characteristic. Objective: To test whether and how user control (the freedom of choice to skip pages) can increase website use and knowledge gained from the website. Methods: Participants older than 18 years were drawn from the Dutch Internet population (in June 2011) and completed a hepatitis knowledge questionnaire. Subsequently, they were randomly assigned to three groups: (1) a tunneled version of the website with less user control; (2) a high user control version of the website where visitors had the freedom of choice to skip pages; and (3) a control group that was not exposed to the website. Participants completed (1) a questionnaire of validated measures regarding user perceptions immediately after exposure to the website (except for the control group), and (2) a hepatitis knowledge questionnaire after one week to test whether participants in the experimental groups only clicked through the website or actually processed and learned its content. Server registrations were used to assess website use. Analyses of covariance (ANCOVA) using all available data were conducted to determine whether user control increases website use. Structural equation models (SEM) using all available data were constructed to test how user control increases website use—a latent variable derived from number of pages visited and time on website. Results: Of the 1044 persons invited to participate, 668 took part (668/1044, 64.0%). One half of participants (332/668 49.7%) were female and the mean age was 49 years (SD 16). A total of 571 participants completed the one-week follow-up measure regarding hepatitis knowledge (571/668, 85.5%). The findings demonstrate that having less user control (ie, a tunneled version of the website) had a negative effect on users’ perception of efficiency (F1,452 = 97.69, P < .001), but a positive effect on number of pages visited (F1,452 = 171.49, P < .001), time on the website (F1,452 = 6.32, P = .01), and knowledge gained from the website (F1,452 = 134.32, P < .001). The direct effect of having less user control appeared to surpass the effect mediated by efficiency, because website use was higher among participants exposed to the tunneled version of the website in comparison with those having the freedom of choice to skip pages. Conclusions: The key finding that visitors demonstrated increased website use in the tunneled version of the website indicates that visitors should be carefully guided through the intervention for future intervention websites. %M 22532074 %R 10.2196/jmir.1922 %U http://www.jmir.org/2012/2/e45/ %U https://doi.org/10.2196/jmir.1922 %U http://www.ncbi.nlm.nih.gov/pubmed/22532074 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 2 %P e26 %T Program Completion of a Web-Based Tailored Lifestyle Intervention for Adults: Differences between a Sequential and a Simultaneous Approach %A Schulz,Daniela N %A Schneider,Francine %A de Vries,Hein %A van Osch,Liesbeth ADM %A van Nierop,Peter WM %A Kremers,Stef PJ %+ CAPHRI School for Public Health and Primary Care, Department of Health Promotion, Maastricht University, P.O. Box 616, Maastricht, 6200 MD, Netherlands, 31 43 3882832, dn.schulz@maastrichtuniversity.nl %K Internet %K dropout %K computer tailoring %K multiple health behavior change intervention %K sequential %K simultaneous %K lifestyle %D 2012 %7 08.03.2012 %9 Original paper %J J Med Internet Res %G English %X Background: Unhealthy lifestyle behaviors often co-occur and are related to chronic diseases. One effective method to change multiple lifestyle behaviors is web-based computer tailoring. Dropout from Internet interventions, however, is rather high, and it is challenging to retain participants in web-based tailored programs, especially programs targeting multiple behaviors. To date, it is unknown how much information people can handle in one session while taking part in a multiple behavior change intervention, which could be presented either sequentially (one behavior at a time) or simultaneously (all behaviors at once). Objectives: The first objective was to compare dropout rates of 2 computer-tailored interventions: a sequential and a simultaneous strategy. The second objective was to assess which personal characteristics are associated with completion rates of the 2 interventions. Methods: Using an RCT design, demographics, health status, physical activity, vegetable consumption, fruit consumption, alcohol intake, and smoking were self-assessed through web-based questionnaires among 3473 adults, recruited through Regional Health Authorities in the Netherlands in the autumn of 2009. First, a health risk appraisal was offered, indicating whether respondents were meeting the 5 national health guidelines. Second, psychosocial determinants of the lifestyle behaviors were assessed and personal advice was provided, about one or more lifestyle behaviors. Results: Our findings indicate a high non-completion rate for both types of intervention (71.0%; n = 2167), with more incompletes in the simultaneous intervention (77.1%; n = 1169) than in the sequential intervention (65.0%; n = 998). In both conditions, discontinuation was predicted by a lower age (sequential condition: OR = 1.04; P < .001; CI = 1.02-1.05; simultaneous condition: OR = 1.04; P < .001; CI = 1.02-1.05) and an unhealthy lifestyle (sequential condition: OR = 0.86; P = .01; CI = 0.76-0.97; simultaneous condition: OR = 0.49; P < .001; CI = 0.42-0.58). In the sequential intervention, being male (OR = 1.27; P = .04; CI = 1.01-1.59) also predicted dropout. When respondents failed to adhere to at least 2 of the guidelines, those receiving the simultaneous intervention were more inclined to drop out than were those receiving the sequential intervention. Conclusion: Possible reasons for the higher dropout rate in our simultaneous intervention may be the amount of time required and information overload. Strategies to optimize program completion as well as continued use of computer-tailored interventions should be studied. Trial Registration: Dutch Trial Register NTR2168 %M 22403770 %R 10.2196/jmir.1968 %U http://www.jmir.org/2012/2/e26/ %U https://doi.org/10.2196/jmir.1968 %U http://www.ncbi.nlm.nih.gov/pubmed/22403770 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 2 %P e43 %T Initial and Sustained Participation in an Internet-delivered Long-term Worksite Health Promotion Program on Physical Activity and Nutrition %A Robroek,Suzan JW %A Lindeboom,Dennis EM %A Burdorf,Alex %+ Department of Public Health, Erasmus MC, PO Box 2040, Rotterdam, 3000CA, Netherlands, 31 107038469, a.burdorf@erasmusmc.nl %K Participation %K Retention %K Internet %K Physical activity %K Nutrition %K Workplace %K Health promotion %D 2012 %7 05.03.2012 %9 Original paper %J J Med Internet Res %G English %X Background: Determinants of participation in health promotion programs are largely unknown. To evaluate and implement interventions, information is needed regarding their reach as well as regarding the characteristics of program users and non-users. Objective: In this study, individual, lifestyle, and health indicators were investigated in relation to initial, and sustained participation in an Internet-delivered physical activity and healthy nutrition program in the workplace setting. In addition, determinants of program website use were studied. Methods: Determinants of participation were investigated in a longitudinal study among employees from six workplaces participating in a two-year cluster randomized controlled trial. The employees were invited by email to participate. At baseline, all participants visited a website to fill out the questionnaire on lifestyle, work, and health factors. Subsequently, a physical health check was offered, followed by face-to-face advice. Throughout the study period, all participants had access to a website with information on lifestyle and health, and to fully automated personalized feedback on the questionnaire results. Only participants in the intervention received monthly email messages to promote website visits during the first year and had access to additional Web-based tools (self-monitors, a food frequency questionnaire assessing saturated fat intake, and the possibility to ask questions) to support behavior change. Website use was monitored by website statistics measuring access. Logistic regression analyses were conducted to identify characteristics of employees who participated in the program and used the website. Results: Complete baseline data were available for 924 employees (intervention: n=456, reference: n=468). Lifestyle and health factors were not associated with initial participation. Employees aged 30 years and older were more likely to start using the program and to sustain their participation. Workers with a low intention to increase their physical activity level were less likely to participate (Odds Ratio (OR)=0.60, 95% Confidence interval (95%CI), 0.43-0.85) but more likely to sustain participation throughout the study period (ORs ranging from 1.40 to 2.06). Furthermore, it was found that smokers were less likely to sustain their participation in the first and second year (OR=0.54, 95%CI 0.35-0.82) and to visit the website (OR=0.72, 95%CI 0.54-0.96). Website use was highest in the periods immediately after the baseline (73%) and follow-up questionnaires (71% and 87%). Employees in the intervention were more likely to visit the website in the period they received monthly emails (OR=5.88, 95%CI 3.75-9.20) but less likely to visit the website in the subsequent period (OR=0.62, 95%CI 0.45-0.85). Conclusions: Modest initial participation and high attrition in program use were found. Workers with a low intention to change their behavior were less likely to participate, but once enrolled they were more likely to sustain their participation. Lifestyle and health indicators were not related to initial participation, but those with an unhealthy lifestyle were less likely to sustain. This might influence program effectiveness. Regular email messages prompted website use, but the use of important Web-based tools was modest. There is a need for more appealing techniques to enhance retention and to keep those individuals who need it most attracted to the program. Trial Registration: ISRCTN52854353; http://www.controlled-trials.com/ISRCTN52854353 %M 22390886 %R 10.2196/jmir.1788 %U http://www.jmir.org/2012/2/e43/ %U https://doi.org/10.2196/jmir.1788 %U http://www.ncbi.nlm.nih.gov/pubmed/22390886 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 2 %P e40 %T The Influence of User Characteristics and a Periodic Email Prompt on Exposure to an Internet-Delivered Computer-Tailored Lifestyle Program %A Schneider,Francine %A van Osch,Liesbeth %A Schulz,Daniela N %A Kremers,Stef PJ %A de Vries,Hein %+ CAPHRI, Department of Health Promotion, Maastricht University, P O Box 616, Maastricht, 6200 MD, Netherlands, 31 43 388 2397, francine.schneider@maastrichtuniversity.nl %K Internet interventions %K computer tailoring %K lifestyle %K behavior change %K program use %K user characteristics %K diffusion %K proactive strategy %K prompts %D 2012 %7 01.03.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: The Internet is a promising medium in the field of health promotion for offering tailored and targeted lifestyle interventions applying computer-tailored (CT) techniques to the general public. Actual exposure to CT interventions is not living up to its high expectations, as only a (limited) proportion of the target group is actually using these programs. Objective: To investigate exposure to an Internet-delivered, CT lifestyle intervention, targeting physical activity, fruit and vegetable intake, smoking behavior, and alcohol intake, we focused on three processes: first use, prolonged use, and sustained use. The first objectives were to identify user characteristics that predict initiation of an online CT lifestyle program (first use) and completion of this program (prolonged use). Furthermore, we studied the effect of using a proactive strategy, consisting of periodic email prompts, on program revisits (sustained use). Methods: The research population for this study consisted of Dutch adults participating in the Adult Health Monitor, offered by the regional public health services. We used a randomized controlled trial design to assess predictors of first use, prolonged use, and sustained use. Demographics and behavioral characteristics, as well as the strategy used for revisiting, were included as predictors in the model. Results: A total of 9169 participants indicated their interest in the new program and 5168 actually logged in to the program. Participants significantly more likely to initiate one of the CT modules were male, older, and employed, and had a lower income, higher body mass index, and relatively unhealthy lifestyle. Participants significantly more likely to complete one of the CT modules were older and had a higher income and a relatively healthier lifestyle. Finally, using a proactive strategy influenced sustained use, with people from the prompting condition being more likely to revisit the program (odds ratio 28.92, 95% confidence interval 10.65–78.52; P < .001). Conclusions: Older, male, and employed participants, and those with a lower income, higher body mass index, and a relatively unhealthy lifestyle were more likely to initiate a CT module. Module completers predominantly had a higher income and age. The current program therefore succeeded in reaching those people who benefit most from online lifestyle interventions. However, these people tended to disengage from the program. This underlines the importance of additional research into program adjustments and strategies that can be used to stimulate prolonged program use. Furthermore, sending periodic email prompts significantly increased revisits to the program. Though promising, this effect was modest and needs to be further examined, in order to maximize the potential of periodic email prompting. Trial Registration: Nederlands Trial Register (NTR: 1786) and Medical Ethics Committee of Maastricht University and the University Hospital Maastricht (NL2723506809/MEC0903016); http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1786 (Archived by WebCite at http://www.webcitation.org/65hBXA6V7) %M 22382037 %R 10.2196/jmir.1939 %U http://www.jmir.org/2012/2/e40/ %U https://doi.org/10.2196/jmir.1939 %U http://www.ncbi.nlm.nih.gov/pubmed/22382037 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 1 %P e37 %T Do Participants’ Preferences for Mode of Delivery (Text, Video, or Both) Influence the Effectiveness of a Web-Based Physical Activity Intervention? %A Vandelanotte,Corneel %A Duncan,Mitch J %A Plotnikoff,Ronald C %A Mummery,W Kerry %+ Centre for Physical Activity Studies, Institute for Health and Social Science Research, Central Queensland University, Buidling 18, Bruce Highway, Rockhampton, 4701, Australia, 61 749232183, c.vandelanotte@cqu.edu.au %K Physical activity: computer tailoring %K mismatch %K preferences %K delivery method %K website-delivered intervention %K behavior-change intervention %D 2012 %7 29.02.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: In randomized controlled trials, participants cannot choose their preferred intervention delivery mode and thus might refuse to participate or not engage fully if assigned to a nonpreferred group. This might underestimate the true effectiveness of behavior-change interventions. Objective: To examine whether receiving interventions either matched or mismatched with participants’ preferred delivery mode would influence effectiveness of a Web-based physical activity intervention. Methods: Adults (n = 863), recruited via email, were randomly assigned to one of three intervention delivery modes (text based, video based, or combined) and received fully automated, Internet-delivered personal advice about physical activity. Personalized intervention content, based on the theory of planned behavior and stages of change concept, was identical across groups. Online, self-assessed questionnaires measuring physical activity were completed at baseline, 1 week, and 1 month. Physical activity advice acceptability and website usability were assessed at 1 week. Before randomization, participants were asked which delivery mode they preferred, to categorize them as matched or mismatched. Time spent on the website was measured throughout the intervention. We applied intention-to-treat, repeated-measures analyses of covariance to assess group differences. Results: Attrition was high (575/863, 66.6%), though equal between groups (t863 =1.31, P =.19). At 1-month follow-up, 93 participants were categorized as matched and 195 as mismatched. They preferred text mode (493/803, 61.4%) over combined (216/803, 26.9%) and video modes (94/803, 11.7%). After the intervention, 20% (26/132) of matched-group participants and 34% (96/282) in the mismatched group changed their delivery mode preference. Time effects were significant for all physical activity outcomes (total physical activity: F2,801 = 5.07, P = .009; number of activity sessions: F2,801 = 7.52, P < .001; walking: F2,801 = 8.32, P < .001; moderate physical activity: F2,801 = 9.53, P < .001; and vigorous physical activity: F2,801 = 6.04, P = .002), indicating that physical activity increased over time for both matched and mismatched groups. Matched-group participants improved physical activity outcomes slightly more than those in the mismatched group, but interaction effects were not significant. Physical activity advice acceptability (content scale: t368 = .10, P = .92; layout scale: t368 = 1.53, P = .12) and website usability (layout scale: t426 = .05, P = .96; ease of use scale: t426 = .21, P = .83) were generally high and did not differ between the matched and mismatched groups. The only significant difference (t621 = 2.16, P = .03) was in relation to total time spent on the website: the mismatched group spent significantly more time on the website (14.4 minutes) than the matched group (12.1 minutes). Conclusion: Participants’ preference regarding delivery mode may not significantly influence intervention outcomes. Consequently, allowing participants to choose their preferred delivery mode may not increase effectiveness of Web-based interventions. %M 22377834 %R 10.2196/jmir.1998 %U http://www.jmir.org/2012/1/e37/ %U https://doi.org/10.2196/jmir.1998 %U http://www.ncbi.nlm.nih.gov/pubmed/22377834 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 1 %P e36 %T Social Influence as a Driver of Engagement in a Web-Based Health Intervention %A Poirier,Josée %A Cobb,Nathan K %+ MeYou Health, LLC, 1 Appleton Street, 4th Floor, Boston, MA, 02116, United States, 1 866 885 2822 ext 919, josee.poirier@meyouhealth.com %K Web-based health interventions %K engagement %K social networks %K social influence %D 2012 %7 22.02.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based health interventions can drive behavior change, but their effectiveness depends on participants’ usage. A well-recognized challenge with these interventions is nonusage attrition or weak engagement that results in participants receiving low doses of the intervention, negatively affecting outcomes. We present an approach based on the theoretical concepts of social influence and complex contagion in an effort to address the engagement problem in a specific, commercial, online behavior change intervention. Objective: To examine the relation between social ties and engagement within a specific online intervention. The aims were (1) to determine whether experiencing the intervention socially influences engagement, such that individuals with social ties show higher engagement than those without ties, and (2) to evaluate whether complex contagion increases engagement—that is, whether engagement increases as the number of ties an individual has in the intervention increases. Methods: We analyzed observational data from 84,828 subscribed members of a specific Web-based intervention, Daily Challenge. We compiled three measures of engagement for every member: email opens, site visits, and challenge completions (response to action prompts). We compared members with and without social ties within the intervention on each measure separately using 2-tailed independent-sample t tests. Finally, we performed linear regressions with each simple engagement measure as the dependent variable and number of social ties as the independent variable. Results: Compared with those without social ties, participants with social ties opened more emails (33.0% vs 27.2%, P < .001), visited the website more often (12.6 vs 6.7 visits, P < .001), and reported completing more of the actions they were prompted to perform (11.0 vs 6.1 actions, P < .001). Social ties were significant predictors of email opens (beta = 0.68, P < .001), site visits (beta = 1.52, P < .001), and reported action completions (beta = 1.32, P < .001). Conclusions: Our initial findings are higher engagement in participants with social ties in the program and are consistent with the view that social influence can drive engagement in a Web-based health intervention. %M 22356829 %R 10.2196/jmir.1957 %U http://www.jmir.org/2012/1/e36/ %U https://doi.org/10.2196/jmir.1957 %U http://www.ncbi.nlm.nih.gov/pubmed/22356829 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 1 %P e32 %T Effects of a Web-Based Intervention for Adults With Chronic Conditions on Patient Activation: Online Randomized Controlled Trial %A Solomon,Michael %A Wagner,Stephen L %A Goes,James %+ Point-of-Care Partners, 11236 NW 49 Street, Coral Springs, FL, 33076, United States, 1 561 400 7091, michael.solomon@pocp.com %K Chronic care %K health information technology %K patient activation %K randomized controlled experiment %K self-management %K Web-based intervention %D 2012 %7 21.02.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: With almost one-half of Americans projected to have at least one chronic condition before 2020, a vital role of the health care system is to develop informed, engaged individuals who are effective self-managers of their health. Self-management interventions (SMIs) delivered face-to-face or by telephone (traditional SMIs) are associated with improved self-management knowledge, skills, and self-efficacy, which are expressed by the composite construct of patient activation, a predictor of health outcomes. Web-based interventions to support self-management across the spectrum of chronic diseases have the potential to reach a broader population of patients for extended periods than do traditional SMIs. However, evidence of the effectiveness of Web-based interventions on patient activation is sparse. High-quality studies featuring controlled comparisons of patients with different chronic conditions are needed to explore the interaction of Web-based interventions and patient activation. Objective: To explore the effect of a Web-based intervention on the patient activation levels of patients with chronic health conditions, measured as attitudes toward knowledge, skills, and confidence in self-managing health. Methods: For this 12-week study, prospective participants were selected from the patient panel of a regional health care system in the United States. The 201 eligible participants were randomly assigned to two groups. Intervention group participants had access to MyHealth Online, a patient portal featuring interactive health applications accessible via the Internet. Control participants had access to a health education website featuring various topics. Patient activation was assessed pre- and posttest using the 13-item patient activation measure. Parametric statistical models (t test, analysis of variance, analysis of covariance) were applied to draw inferences. Results: The Web-based intervention demonstrated a positive and significant effect on the patient activation levels of participants in the intervention group. A significant difference in posttest patient activation scores was found between the two groups (F1,123 = 4.438, P = .04, r = .196). Patients starting at the most advanced development of patient activation (stage 4) in the intervention group did not demonstrate significant change compared with participants beginning at earlier stages. Conclusions: To our knowledge, this is the first study to measure change in patient activation when a Web-based intervention is used by patients living with different chronic conditions. Results suggest that Web-based interventions increase patient activation and have the potential to enhance the self-management capabilities of the growing population of chronically ill people. Activated patients are more likely to adhere to recommended health care practices, which in turn leads to improved health outcomes. Designing Web-based interventions to target a specific stage of patient activation may optimize their effectiveness. For Web-based interventions to reach their potential as a key component of chronic disease management, evidence is needed that this technology produces benefits for a sustained period among a diverse population. %M 22353433 %R 10.2196/jmir.1924 %U http://www.jmir.org/2012/1/e32/ %U https://doi.org/10.2196/jmir.1924 %U http://www.ncbi.nlm.nih.gov/pubmed/22353433 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 1 %P e18 %T Identifying Factors for Optimal Development of Health-Related Websites: A Delphi Study Among Experts and Potential Future Users %A Schneider,Francine %A van Osch,Liesbeth %A de Vries,Hein %+ CAPHRI, Department of Health Promotion, Maastricht University, P.O. Box 616, Maastricht, 6200 MD, Netherlands, 31 433882397, francine.schneider@maastrichtuniversity.nl %K Health promotion %K Internet interventions %K health behavior change %K optimal development %K Delphi study %K experts %K users %D 2012 %7 14.02.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: The Internet has become a popular medium for offering tailored and targeted health promotion programs to the general public. However, suboptimal levels of program use in the target population limit the public health impact of these programs. Optimizing program development is considered as one of the main processes to increase usage rates. Objective: To distinguish factors potentially related to optimal development of health-related websites by involving both experts and potential users. By considering and incorporating the opinions of experts and potential users in the development process, involvement in the program is expected to increase, consequently resulting in increased appreciation, lower levels of attrition, and higher levels of sustained use. Methods: We conducted a systematic three-round Delphi study through the Internet. Both national and international experts (from the fields of health promotion, health psychology, e-communication, and technical Web design) and potential users were invited via email to participate. During this study an extensive list of factors potentially related to optimal development of health-related websites was identified, by focusing on factors related to layout, general and risk information provision, questionnaire use, additional services, and ease of use. Furthermore, we assessed the extent to which experts and potential users agreed on the importance of these factors. Differences as well as similarities among experts and potentials users were deduced. Results: In total, 20 of 62 contacted experts participated in the first round (32% response rate); 60 of 200 contacted experts (30% response rate) and 210 potential users (95% response rate) completed the second-round questionnaire, and 32 of 60 contacted experts completed the third round (53% response rate). Results revealed important factors consented upon by experts and potential users (eg, ease of use, clear structure, and detailed health information provision), as well as differences regarding important factors consented upon by experts (eg, visual aids, self-monitoring tool, and iterative health feedback) or by potential users only (eg, bread crumb navigation and prevention of receiving spam). Conclusions: This study is an important first step in determining the agreed-upon factors that should be taken into account when developing online health promotion programs. The public health impact of these programs will be improved by optimizing the development process in line with these factors. %M 22357411 %R 10.2196/jmir.1863 %U http://www.jmir.org/2012/1/e18/ %U https://doi.org/10.2196/jmir.1863 %U http://www.ncbi.nlm.nih.gov/pubmed/22357411 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 1 %P e23 %T Breathe Easier Online: Evaluation of a Randomized Controlled Pilot Trial of an Internet-Based Intervention to Improve Well-being in Children and Adolescents With a Chronic Respiratory Condition %A Newcombe,Peter A %A Dunn,Tamara L %A Casey,Leanne M %A Sheffield,Jeanie K %A Petsky,Helen %A Anderson-James,Sophie %A Chang,Anne B %+ School of Psychology, University of Queensland, Bldg 24, Room s323, Brisbane, 4072, Australia, 61 7 33469643, newc@psy.uq.edu.au %K Internet-based intervention %K chronic respiratory condition %K psychosocial well-being %K children and adolescents %K randomized controlled trial %D 2012 %7 08.02.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic respiratory illnesses are the most common group of childhood chronic health conditions and are overrepresented in socially isolated groups. Objective: To conduct a randomized controlled pilot trial to evaluate the efficacy of Breathe Easier Online (BEO), an Internet-based problem-solving program with minimal facilitator involvement to improve psychosocial well-being in children and adolescents with a chronic respiratory condition. Methods: We randomly assigned 42 socially isolated children and adolescents (18 males), aged between 10 and 17 years to either a BEO (final n = 19) or a wait-list control (final n = 20) condition. In total, 3 participants (2 from BEO and 1 from control) did not complete the intervention. Psychosocial well-being was operationalized through self-reported scores on depression symptoms and social problem solving. Secondary outcome measures included self-reported attitudes toward their illness and spirometry results. Paper-and-pencil questionnaires were completed at the hospital when participants attended a briefing session at baseline (time 1) and in their homes after the intervention for the BEO group or a matched 9-week time period for the wait-list group (time 2). Results: The two groups were comparable at baseline across all demographic measures (all F < 1). For the primary outcome measures, there were no significant group differences on depression (P = .17) or social problem solving (P = .61). However, following the online intervention, those in the BEO group reported significantly lower depression (P = .04), less impulsive/careless problem solving (P = .01), and an improvement in positive attitude toward their illness (P = .04) compared with baseline. The wait-list group did not show these differences. Children in the BEO group and their parents rated the online modules very favorably. Conclusions: Although there were no significant group differences on primary outcome measures, our pilot data provide tentative support for the feasibility (acceptability and user satisfaction) and initial efficacy of an Internet-based intervention for improving well-being in children and adolescents with a chronic respiratory condition. Trial registration: Australian New Zealand Clinical Trials Registry number: ACTRN12610000214033; http://www.anzctr.org.au/trial_view.aspx?ID=308074 (Archived by WebCite at http://www.webcitation.org/63BL55mXH) %M 22356732 %R 10.2196/jmir.1997 %U http://www.jmir.org/2012/1/e23/ %U https://doi.org/10.2196/jmir.1997 %U http://www.ncbi.nlm.nih.gov/pubmed/22356732 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 1 %P e5 %T Interpreting the Outcomes of Automated Internet-Based Randomized Trials: Example of an International Smoking Cessation Study %A Leykin,Yan %A Aguilera,Adrian %A Torres,Leandro D %A Pérez-Stable,Eliseo J %A Muñoz,Ricardo F %+ San Francisco General Hospital, University of California, San Francisco, 1001 Potrero Avenue, Suite 7M, San Francisco, CA, 94110, United States, 1 415 206 5214, ricardo.munoz@ucsf.edu %K Smoking cessation %K tobacco use %K Internet intervention %K evidence-based intervention %K attrition %K effectiveness trial %D 2012 %7 07.02.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Smoking is one of the largest contributors to the global burden of disease. Internet interventions have been shown to reduce smoking rates successfully. However, improved methods of evaluating effectiveness need to be developed for large-scale Internet intervention trials. Objective: To illustrate a method to interpret outcomes of large-scale, fully automated, worldwide Internet intervention trials. Methods: A fully automated, international, Internet-based smoking cessation randomized controlled trial was conducted in Spanish and English, with 16,430 smokers from 165 countries. The randomized controlled trial replicated a published efficacy trial in which, to reduce follow-up attrition, 1000 smokers were followed up by phone if they did not provide online follow-up data. Results: The 7-day self-reported abstinence rates ranged from 36.18% (2239/6189) at 1 month to 41.34% (1361/3292) at 12 months based on observed data. Given high rates of attrition in this fully automated trial, when participants unreachable at follow-up were presumed to be smoking, the abstinence rates ranged from 13.63% (2239/16.430) at 1 month to 8.28% (1361/16,430) at 12 months. We address the problem of interpreting results with high follow-up attrition rates and propose a solution based on a smaller study with intensive phone follow-up. Conclusions: Internet-based smoking cessation interventions can help large numbers of smokers quit. Large-scale international outcome studies can be successfully implemented using automated Internet sites. Interpretation of the studies’ results can be aided by extrapolating from results obtained from subsamples that are followed up by phone or similar cohort maintenance methods. Trial Registration: ClinicalTrials.gov NCT00721786; http://clinicaltrials.gov/ct2/show/NCT00721786 (Archived by WebCite at http://www.webcitation.org/63mhoXYPw) %M 22314016 %R 10.2196/jmir.1829 %U http://www.jmir.org/2012/1/e5/ %U https://doi.org/10.2196/jmir.1829 %U http://www.ncbi.nlm.nih.gov/pubmed/22314016 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 1 %P e24 %T Usability Evaluation of a Web-Based Support System for People With a Schizophrenia Diagnosis %A van der Krieke,Lian %A Emerencia,Ando C %A Aiello,Marco %A Sytema,Sjoerd %+ University Center for Psychiatry, University Medical Center Groningen, University of Groningen, PO Box 30.001, Groningen, 9700 RB, Netherlands, 31 50 361 21 08, j.a.j.van.der.krieke@umcg.nl %K Schizophrenia %K Web-Based systems %K Recommendation systems %K usability testing %K self-management %D 2012 %7 06.02.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Routine Outcome Monitoring (ROM) is a systematic way of assessing service users’ health conditions for the purpose of better aiding their care. ROM consists of various measures used to assess a service user’s physical, psychological, and social condition. While ROM is becoming increasingly important in the mental health care sector, one of its weaknesses is that ROM is not always sufficiently service user-oriented. First, clinicians tend to concentrate on those ROM results that provide information about clinical symptoms and functioning, whereas it has been suggested that a service user-oriented approach needs to focus on personal recovery. Second, service users have limited access to ROM results and they are often not equipped to interpret them. These problems need to be addressed, as access to resources and the opportunity to share decision making has been indicated as a prerequisite for service users to become a more equal partner in communication with their clinicians. Furthermore, shared decision making has been shown to improve the therapeutic alliance and to lead to better care. Objective: Our aim is to build a web-based support system which makes ROM results more accessible to service users and to provide them with more concrete and personalized information about their functioning (ie, symptoms, housing, social contacts) that they can use to discuss treatment options with their clinician. In this study, we will report on the usability of the web-based support system for service users with schizophrenia. Methods: First, we developed a prototype of a web-based support system in a multidisciplinary project team, including end-users. We then conducted a usability study of the support system consisting of (1) a heuristic evaluation, (2) a qualitative evaluation and (3) a quantitative evaluation. Results: Fifteen service users with a schizophrenia diagnosis and four information and communication technology (ICT) experts participated in the study. The results show that people with a schizophrenia diagnosis were able to use the support system easily. Furthermore, the content of the advice generated by the support system was considered meaningful and supportive. Conclusions: This study shows that the support system prototype has valuable potential to improve the ROM practice and it is worthwhile to further develop it into a more mature system. Furthermore, the results add to prior research into web applications for people with psychotic disorders, in that it shows that this group of end users can work with web-based and computer-based systems, despite the cognitive problems they experience. %M 22311883 %R 10.2196/jmir.1921 %U http://www.jmir.org/2012/1/e24/ %U https://doi.org/10.2196/jmir.1921 %U http://www.ncbi.nlm.nih.gov/pubmed/22311883 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 1 %P e1 %T An Internet-Based Virtual Coach to Promote Physical Activity Adherence in Overweight Adults: Randomized Controlled Trial %A Watson,Alice %A Bickmore,Timothy %A Cange,Abby %A Kulshreshtha,Ambar %A Kvedar,Joseph %+ Center for Connected Health, Partners HealthCare, 25 New Chardon Street, Suite 400D, Boston, MA, 02114, United States, 1 617 913 2620, ajwatson@partners.org %K Activity monitoring %K pedometers %K obesity %K body mass index %K telemedicine %K telehealth %D 2012 %7 26.01.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Addressing the obesity epidemic requires the development of effective, scalable interventions. Pedometers and Web-based programs are beneficial in increasing activity levels but might be enhanced by the addition of nonhuman coaching. Objectives: We hypothesized that a virtual coach would increase activity levels, via step count, in overweight or obese individuals beyond the effect observed using a pedometer and website alone. Methods: We recruited 70 participants with a body mass index (BMI) between 25 and 35 kg/m2 from the Boston metropolitan area. Participants were assigned to one of two study arms and asked to wear a pedometer and access a website to view step counts. Intervention participants also met with a virtual coach, an automated, animated computer agent that ran on their home computers, set goals, and provided personalized feedback. Data were collected and analyzed in 2008. The primary outcome measure was change in activity level (percentage change in step count) over the 12-week study, split into four 3-week time periods. Major secondary outcomes were change in BMI and participants’ satisfaction. Results: The mean age of participants was 42 years; the majority of participants were female (59/70, 84%), white (53/70, 76%), and college educated (68/70, 97%). Of the initial 70 participants, 62 completed the study. Step counts were maintained in intervention participants but declined in controls. The percentage change in step count between those in the intervention and control arms, from the start to the end, did not reach the threshold for significance (2.9% vs –12.8% respectively, P = .07). However, repeated measures analysis showed a significant difference when comparing percentage changes in step counts between control and intervention participants over all time points (analysis of variance, P = .02). There were no significant changes in secondary outcome measures. Conclusions: The virtual coach was beneficial in maintaining activity level. The long-term benefits and additional applications of this technology warrant further study. Trial Registration: ClinicalTrials.gov NCT00792207; http://clinicaltrials.gov/ct2/show/NCT00792207 (Archived by WebCite at http://www.webcitation.org/63sm9mXUD) %M 22281837 %R 10.2196/jmir.1629 %U http://www.jmir.org/2012/1/e1/ %U https://doi.org/10.2196/jmir.1629 %U http://www.ncbi.nlm.nih.gov/pubmed/22281837 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 1 %P e16 %T Primary Care Providers’ Perspectives on Online Weight-Loss Programs: A Big Wish List %A Hwang,Kevin O %A Stuckey,Heather L %A Chen,Monica C %A Kraschnewski,Jennifer L %A Forjuoh,Samuel N %A Poger,Jennifer M %A McTigue,Kathleen M %A Sciamanna,Christopher N %+ Department of Internal Medicine, The University of Texas Medical School at Houston, 6410 Fannin St, UPB 1100.41, Houston, TX, 77030, United States, 1 713 500 6441, kevin.o.hwang@uth.tmc.edu %K Obesity %K weight management %K primary care %D 2012 %7 19.01.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Integrating online weight-loss programs into the primary care setting could yield substantial public health benefit. Little is known about primary care providers’ perspectives on online weight-loss programs. Objective: To assess primary care providers’ perspectives on online weight-loss programs. Methods: We conducted focus group discussions with providers in family medicine, internal medicine, and combined internal medicine/pediatrics in Texas and Pennsylvania, USA. Open-ended questions addressed their experience with and attitudes toward online weight-loss programs; useful characteristics of existing online weight-loss programs; barriers to referring patients to online weight-loss programs; and preferred characteristics of an ideal online weight-loss program. Transcripts were analyzed with the grounded theory approach to identify major themes. Results: A total of 44 primary care providers participated in 9 focus groups. The mean age was 45 (SD 9) years. Providers had limited experience with structured online weight-loss programs and were uncertain about their safety and efficacy. They thought motivated, younger patients would be more likely than others to respond to an online weight-loss program. According to primary care providers, an ideal online weight-loss program would provide—at no cost to the patient—a structured curriculum addressing motivation, psychological issues, and problem solving; tools for tracking diet, exercise, and weight loss; and peer support monitored by experts. Primary care providers were interested in receiving reports about patients from the online weight-loss programs, but were concerned about the time required to review and act on the reports. Conclusions: Primary care providers have high expectations for how online weight-loss programs should deliver services to patients and fit into the clinical workflow. Efforts to integrate online weight-loss programs into the primary care setting should address efficacy and safety of online weight-loss programs in clinic-based populations; acceptable methods of sending reports to primary care providers about their patients’ progress; and elimination or reduction of costs to patients. %M 22262726 %R 10.2196/jmir.1955 %U http://www.jmir.org/2012/1/e16/ %U https://doi.org/10.2196/jmir.1955 %U http://www.ncbi.nlm.nih.gov/pubmed/22262726 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 1 %P e4 %T Prospective Associations Between Intervention Components and Website Engagement in a Publicly Available Physical Activity Website: The Case of 10,000 Steps Australia %A Davies,Cally %A Corry,Kelly %A Van Itallie,Anetta %A Vandelanotte,Corneel %A Caperchione,Cristina %A Mummery,W Kerry %+ Centre for Physical Activity Studies, Institute for Health and Social Science Research, CQUniversity Australia, Building 18, Bruce Highway, Rockhampton, Queensland, 4702, Australia, 61 49232263, c.davies@cqu.edu.au %K Physical activity %K engagement %D 2012 %7 11.01.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Effectiveness of and engagement with website-delivered physical activity interventions is moderate at best. Increased exposure to Internet interventions is reported to increase their effectiveness; however, there is a lack of knowledge about which specific intervention elements are able to maintain website engagement. Objective: To prospectively study the associations of website engagement and exposure to intervention components for a publicly available physical activity website (10,000 Steps Australia). Methods: Between June and July 2006 a total of 348 members of 10,000 Steps completed a Web-based survey to collect demographic characteristics. Website engagement was subsequently assessed over a 2-year period and included engagement data on website components; individual challenges, team challenges, and virtual walking buddies; and indicators of website engagement (average steps logged, days logging steps, and active users). Results: On average participants logged steps on 169 (SD 228.25) days. Over a 2-year period this equated to an average of 1.6 logons per week. Binary logistic regression showed that individuals who participated in individual challenges were more likely to achieve an average of 10,000 steps per day (odds ratio [OR] = 2.80, 95% confidence interval [CI] 1.45–5.40), log steps on a higher than average number of days (OR = 6.81, 95% CI 2.87–13.31), and remain an active user (OR = 4.36, 95% CI 2.17–8.71). Additionally, those using virtual walking buddies (OR = 5.83, 95% CI 1.27–26.80) and of older age logged steps on a higher than average number of days. No significant associations were found for team challenges. Conclusions: Overall engagement with the 10,000 Steps website was high, and the results demonstrate the relative effectiveness of interactive components to enhance website engagement. However, only exposure to the interactive individual challenge feature was positively associated with all website engagement indicators. More research is needed to examine the influence of intervention components on website engagement, as well as the relationship between website engagement and physical activity change. %M 22260810 %R 10.2196/jmir.1792 %U http://www.jmir.org/2012/1/e4/ %U https://doi.org/10.2196/jmir.1792 %U http://www.ncbi.nlm.nih.gov/pubmed/22260810 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 14 %N 1 %P e2 %T Is a Severe Clinical Profile an Effect Modifier in a Web-Based Depression Treatment for Adults With Type 1 or Type 2 Diabetes? Secondary Analyses From a Randomized Controlled Trial %A van Bastelaar,Kim MP %A Pouwer,François %A Cuijpers,Pim %A Riper,Heleen %A Twisk,Jos WR %A Snoek,Frank J %+ Department of Medical Psychology, VU University Medical Centre, Van der Boechorststraat 7, Amsterdam, 1081 BT, Netherlands, 31 204448228, fj.snoek@vumc.nl %K Diabetes mellitus, type 1 %K diabetes mellitus, type 2 %K depression %K behavior therapy %K cognitive therapy %K depressive disorder %K adults %K psychology %D 2012 %7 05.01.2012 %9 Original Paper %J J Med Internet Res %G English %X Background: Depression and diabetes are two highly prevalent and co-occurring health problems. Web-based, diabetes-specific cognitive behavioral therapy (CBT) depression treatment is effective in diabetes patients, and has the potential to be cost effective and to have large reach. A remaining question is whether the effectiveness differs between patients with seriously impaired mental health and patients with less severe mental health problems. Objective: To test whether the effectiveness of an eight-lesson Web-based, diabetes-specific CBT for depression, with minimal therapist support, differs in patients with or without diagnosed major depressive disorder (MDD), diagnosed anxiety disorder, or elevated diabetes-specific emotional distress (DM-distress). Methods: We used data of 255 patients with diabetes with elevated depression scores, who were recruited via an open access website for participation in a randomized controlled trial, conducted in 2008–2009, comparing a diabetes-specific, Web-based, therapist-supported CBT with a 12-week waiting-list control group. We performed secondary analyses on these data to study whether MDD or anxiety disorder (measured using a telephone-administered diagnostic interview) and elevated DM-distress (online self-reported) are effect modifiers in the treatment of depressive symptoms (online self-reported) with Web-based diabetes-specific CBT. Results: MDD, anxiety disorder, and elevated DM-distress were not significant effect modifiers in the treatment of self-assessed depressive symptoms with Web-based diabetes-specific CBT. Conclusions: This Web-based diabetes-specific CBT depression treatment is suitable for use in patients with severe mental health problems and those with a less severe clinical profile. ClinicalTrial: International Standard Randomized Controlled Trial Number (ISRCTN): 24874457; http://www.controlled-trials.com/ISRCTN24874457 (Archived by WebCite at http://www.webcitation.org/63hwdviYr) %M 22262728 %R 10.2196/jmir.1657 %U http://www.jmir.org/2012/1/e2/ %U https://doi.org/10.2196/jmir.1657 %U http://www.ncbi.nlm.nih.gov/pubmed/22262728 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 4 %P e126 %T CONSORT-EHEALTH: Improving and Standardizing Evaluation Reports of Web-based and Mobile Health Interventions %A Eysenbach,Gunther %A , %+ University Health Network, Centre for Global eHealth Innovation & Techna Institute, 190 Elizabeth St, Toronto, ON, M4L3Y7, Canada, 1 416 7866970, geysenba@uhnres.utoronto.ca %K evaluation %K Internet %K mobile health %K reporting standards %K publishing standards %K guidelines %K quality control %K randomized controlled trials as topic %K medical informatics %D 2011 %7 31.12.2011 %9 Editorial %J J Med Internet Res %G English %X Background: Web-based and mobile health interventions (also called “Internet interventions” or "eHealth/mHealth interventions") are tools or treatments, typically behaviorally based, that are operationalized and transformed for delivery via the Internet or mobile platforms. These include electronic tools for patients, informal caregivers, healthy consumers, and health care providers. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the suboptimal reporting of randomized controlled trials (RCTs). While the CONSORT statement can be applied to provide broad guidance on how eHealth and mHealth trials should be reported, RCTs of web-based interventions pose very specific issues and challenges, in particular related to reporting sufficient details of the intervention to allow replication and theory-building. Objective: To develop a checklist, dubbed CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth), as an extension of the CONSORT statement that provides guidance for authors of eHealth and mHealth interventions. Methods: A literature review was conducted, followed by a survey among eHealth experts and a workshop. Results: A checklist instrument was constructed as an extension of the CONSORT statement. The instrument has been adopted by the Journal of Medical Internet Research (JMIR) and authors of eHealth RCTs are required to submit an electronic checklist explaining how they addressed each subitem. Conclusions: CONSORT-EHEALTH has the potential to improve reporting and provides a basis for evaluating the validity and applicability of eHealth trials. Subitems describing how the intervention should be reported can also be used for non-RCT evaluation reports. As part of the development process, an evaluation component is essential; therefore, feedback from authors will be solicited, and a before-after study will evaluate whether reporting has been improved. %M 22209829 %R 10.2196/jmir.1923 %U http://www.jmir.org/2011/4/e126/ %U https://doi.org/10.2196/jmir.1923 %U http://www.ncbi.nlm.nih.gov/pubmed/22209829 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 4 %P e117 %T Attrition in Web-Based Treatment for Problem Drinkers %A Postel,Marloes G %A de Haan,Hein A %A ter Huurne,Elke D %A van der Palen,Job %A Becker,Eni S %A de Jong,Cor AJ %+ Tactus Addiction Treatment, Institutenweg 1, Enschede, 7521 PH, Netherlands, 31 534824750, m.postel@tactus.nl %K Web-based treatment %K online treatment %K problem drinking %K alcohol %K attrition %K dropout %D 2011 %7 27.12.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based interventions for problem drinking are effective but characterized by high rates of attrition. There is a need to better understand attrition rates in order to improve the completion rates and the success of Web-based treatment programs. Objective: The objectives of our study were to (1) examine attrition prevalence and pretreatment predictors of attrition in a sample of open-access users of a Web-based program for problem drinkers, and (2) to further explore attrition data from our randomized controlled trial (RCT) of the Web-based program. Methods: Attrition data from two groups of Dutch-speaking problem drinkers were collected: (1) open-access participants enrolled in the program in 2009 (n = 885), and (2) RCT participants (n = 156). Participants were classified as noncompleters if they did not complete all 12 treatment sessions (9 assignments and 3 assessments). In both samples we assessed prevalence of attrition and pretreatment predictors of treatment completion. Logistic regression analysis was used to explore predictors of treatment completion. In the RCT sample, we additionally measured reasons for noncompletion and participants’ suggestions to enhance treatment adherence. The qualitative data were analyzed using thematic analysis. Results: The open-access and RCT group differed significantly in the percentage of treatment completers (273/780, 35.0% vs 65/144, 45%, χ21 = 5.4, P = .02). Logistic regression analysis revealed a significant contribution of treatment readiness, gender, education level, age, baseline alcohol consumption, and readiness to change to predict treatment completion. The key reasons for noncompletion were personal reasons, dissatisfaction with the intervention, and satisfaction with their own improvement. The main suggestions for boosting strategies involved email notification and more flexibility in the intervention. Conclusions: The challenge of Web-based alcohol treatment programs no longer seems to be their effectiveness but keeping participants involved until the end of the treatment program. Further research should investigate whether the suggested strategies to improve adherence decrease attrition rates in Web-based interventions. If we can succeed in improving attrition rates, the success of Web-based alcohol interventions will also improve and, as a consequence, their public health impact will increase. Trial: International Standard Randomized Controlled Trial Number (ISRCTN): 39104853; http://www.controlled-trials.com/ISRCTN39104853 (Archived by WebCite at http://www.webcitation.org/63IKDul1T) %M 22201703 %R 10.2196/jmir.1811 %U http://www.jmir.org/2011/4/e117/ %U https://doi.org/10.2196/jmir.1811 %U http://www.ncbi.nlm.nih.gov/pubmed/22201703 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 4 %P e116 %T Effectiveness of Web-Based Versus Face-To-Face Delivery of Education in Prescription of Falls-Prevention Exercise to Health Professionals: Randomized Trial %A Maloney,Stephen %A Haas,Romi %A Keating,Jennifer L %A Molloy,Elizabeth %A Jolly,Brian %A Sims,Jane %A Morgan,Prue %A Haines,Terry %+ Department of Physiotherapy, Monash University, PO Box 527, Frankston, 3199, Australia, 61 3 99044240, stephen.maloney@monash.edu %K Education %K professional development %K course design %K distance education %K students %D 2011 %7 22.12.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Exercise is an effective intervention for the prevention of falls; however, some forms of exercises have been shown to be more effective than others. There is a need to identify effective and efficient methods for training health professionals in exercise prescription for falls prevention. Objective: The objective of our study was to compare two approaches for training clinicians in prescribing exercise to prevent falls. Methods: This study was a head-to-head randomized trial design. Participants were physiotherapists, occupational therapists, nurses, and exercise physiologists working in Victoria, Australia. Participants randomly assigned to one group received face-to-face traditional education using a 1-day seminar format with additional video and written support material. The other participants received Web-based delivery of the equivalent educational material over a 4-week period with remote tutor facilitation. Outcomes were measured across levels 1 to 3 of Kirkpatrick’s hierarchy of educational outcomes, including attendance, adherence, satisfaction, knowledge, and self-reported change in practice. Results: Of the 166 participants initially recruited, there was gradual attrition from randomization to participation in the trial (n = 67 Web-based, n = 68 face-to-face), to completion of the educational content (n = 44 Web-based, n = 50 face-to-face), to completion of the posteducation examinations (n = 43 Web-based, n = 49 face-to-face). Participant satisfaction was not significantly different between the intervention groups: mean (SD) satisfaction with content and relevance of course material was 25.73 (5.14) in the Web-based and 26.11 (5.41) in the face-to-face group; linear regression P = .75; and mean (SD) satisfaction with course facilitation and support was 11.61 (2.00) in the Web-based and 12.08 (1.54) in the face-to-face group; linear regression P = .25. Knowledge test results were comparable between the Web-based and face-to-face groups: median (interquartile range [IQR]) for the Web-based group was 90.00 (70.89–90.67) and for the face-to-face group was 80.56 (70.67–90.00); rank sum P = .07. The median (IQR) scores for the exercise assignment were also comparable: Web-based, 78.6 (68.5–85.1), and face-to-face, 78.6 (70.8–86.9); rank sum P = .61. No significant difference was identified in Kirkpatrick’s hierarchy domain change in practice: mean (SD) Web-based, 21.75 (4.40), and face-to-face, 21.88 (3.24); linear regression P = .89. Conclusion: Web-based and face-to-face approaches to the delivery of education to clinicians on the subject of exercise prescription for falls prevention produced equivalent results in all of the outcome domains. Practical considerations should arguably drive choice of delivery method, which may favor Web-based provision for its ability to overcome access issues for health professionals in regional and remote settings. Trial Registration: Australian New Zealand Clinical Trials Registry number: ACTRN12610000135011; http://www.anzctr.org.au/ACTRN12610000135011.aspx (Archived by WebCite at http://www.webcitation.org/63MicDjPV) %M 22189410 %R 10.2196/jmir.1680 %U http://www.jmir.org/2011/4/e116/ %U https://doi.org/10.2196/jmir.1680 %U http://www.ncbi.nlm.nih.gov/pubmed/22189410 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 4 %P e120 %T Tweets, Apps, and Pods: Results of the 6-Month Mobile Pounds Off Digitally (Mobile POD) Randomized Weight-Loss Intervention Among Adults %A Turner-McGrievy,Gabrielle %A Tate,Deborah %+ Department of Health Promotion, Education, and Behavior, University of South Carolina, 800 Sumter Street, Room 216, Columbia, SC, 29208, United States, 1 803 777 3932, brie@sc.edu %K Weight loss %K obesity %K podcasts as topic %K social support %D 2011 %7 20.12.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Previous interventions have shown promising results using theory-based podcasts to deliver a behavioral weight-loss intervention. Objective: The objective of our study was to examine whether a combination of podcasting, mobile support communication, and mobile diet monitoring can assist people in weight loss. Methods: In this 6-month, minimal contact intervention, overweight (n = 96, body mass index 32.6 kg/m2) adults were recruited through television advertisements and email listservs and randomly assigned to Podcast-only or Podcast+Mobile groups. Both groups received 2 podcasts per week for 3 months and 2 minipodcasts per week for months 3–6. In addition to the podcasts, the Podcast+Mobile group was also instructed to use a diet and physical activity monitoring application (app) on their mobile device and to interact with study counselors and other participants on Twitter. Results: Weight loss did not differ by group at 6 months: mean –2.7% (SD 5.6%) Podcast+Mobile, n = 47; mean –2.7% (SD 5.1%) Podcast, n = 49; P = .98. Days/week of reported diet monitoring did not differ between Podcast+Mobile (mean 2.3, SD 1.9 days/week) and Podcast groups (mean 1.9, SD 1.7 days/week; P = .28) but method of monitoring did differ. Podcast+Mobile participants were 3.5 times more likely than the Podcast group to use an app to monitor diet (P = .01), whereas the majority of Podcast participants reported using the Web (14/41, 34%) or paper (12/41, 29%). There were more downloads per episode in the Podcast+Mobile group (1.4/person) than in the Podcast group (1.1/person; P < .001). The number of podcasts participants reported downloading over the 6-month period was significantly moderately correlated with weight loss in both the Podcast+Mobile (r = –.46, P = .001) and the Podcast (r = –.53, P < .001) groups. Podcast+Mobile participants felt more user control at 3 months (P = .02), but not at 6 months, and there was a trend (P = .06) toward greater elaboration among Podcast+Mobile participants. There were significant differences in reported source of social support between groups. More Podcast participants relied on friends (11/40, 28% vs 4/40, 10%; P = .045) whereas Podcast+Mobile participants relied on online sources (10/40, 25% vs 0/40; P = .001). Conclusions: Results confirm and extend previous findings showing a minimally intensive weight-loss intervention can be delivered via podcast, but prompting and mobile communication via Twitter and monitoring app without feedback did not enhance weight loss. Trial Registration: Clinicaltrials.gov NCT01139255; http://clinicaltrials.gov/ct2/show/NCT01139255 (Archived by WebCite at http://www.webcitation.org/625OjhiDy) %M 22186428 %R 10.2196/jmir.1841 %U http://www.jmir.org/2011/4/e120/ %U https://doi.org/10.2196/jmir.1841 %U http://www.ncbi.nlm.nih.gov/pubmed/22186428 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 4 %P e118 %T Exploratory Study of Web-Based Planning and Mobile Text Reminders in an Overweight Population %A Soureti,Anastasia %A Murray,Peter %A Cobain,Mark %A Chinapaw,Mai %A van Mechelen,Willem %A Hurling,Robert %+ Unilever Discover, Colworth Science Park, Bedforshire, MK44 1LQ, United Kingdom, 44 44 1234 248189, natasha.soureti@unilever.com %K Implementation intentions %K mobile text reminders %K saturated fat %D 2011 %7 20.12.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Forming specific health plans can help translate good intentions into action. Mobile text reminders can further enhance the effects of planning on behavior. Objective: Our aim was to explore the combined impact of a Web-based, fully automated planning tool and mobile text reminders on intention to change saturated fat intake, self-reported saturated fat intake, and portion size changes over 4 weeks. Methods: Of 1013 men and women recruited online, 858 were randomly allocated to 1 of 3 conditions: a planning tool (PT), combined planning tool and text reminders (PTT), and a control group. All outcome measures were assessed by online self-reports. Analysis of covariance was used to analyze the data. Results: Participants allocated to the PT (meansaturatedfat 3.6, meancopingplanning 3) and PTT (meansaturatedfat 3.5, meancopingplanning 3.1) reported a lower consumption of high-fat foods (F2,571 = 4.74, P = .009) and higher levels of coping planning (F2,571 = 7.22, P < .001) than the control group (meansaturatedfat 3.9, meancopingplanning 2.8). Participants in the PTT condition also reported smaller portion sizes of high-fat foods (mean 2.8; F2,569 = 4.12, P = .0) than the control group (meanportions 3.1). The reduction in portion size was driven primarily by the male participants in the PTT (P = .003). We found no significant group differences in terms of percentage saturated fat intake, intentions, action planning, self-efficacy, or feedback on the intervention. Conclusions: These findings support the use of Web-based tools and mobile technologies to change dietary behavior. The combination of a fully automated Web-based planning tool with mobile text reminders led to lower self-reported consumption of high-fat foods and greater reductions in portion sizes than in a control condition. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 61819220; http://www.controlled-trials.com/ISRCTN61819220 (Archived by WebCite at http://www.webcitation.org/63YiSy6R8) %M 22182483 %R 10.2196/jmir.1773 %U http://www.jmir.org/2011/4/e118/ %U https://doi.org/10.2196/jmir.1773 %U http://www.ncbi.nlm.nih.gov/pubmed/22182483 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 4 %P e121 %T Effect of Tailoring in an Internet-Based Intervention for Smoking Cessation: Randomized Controlled Trial %A Wangberg,Silje C %A Nilsen,Olav %A Antypas,Konstantinos %A Gram,Inger Torhild %+ Regional Centre on Substance Abuse, University Hospital of North Norway, PO Box 385, Narvik, NO-8505, Norway, 47 76 96 65 00, siljecw@gmail.com %K Smoking cessation %K tailored feedback %K email %D 2011 %7 15.12.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Studies suggest that tailored materials are superior to nontailored materials in supporting health behavioral change. Several trials on tailored Internet-based interventions for smoking cessation have shown good effects. There have, however, been few attempts to isolate the effect of the tailoring component of an Internet-based intervention for smoking cessation and to compare it with the effectiveness of the other components. Objective: The study aim was to isolate the effect of tailored emails in an Internet-based intervention for smoking cessation by comparing two versions of the intervention, with and without tailored content. Methods: We conducted a two-arm, randomized controlled trial of the open and free Norwegian 12-month follow-up, fully automated Internet-based intervention for smoking cessation, slutta.no. We collected information online on demographics, smoking, self-efficacy, use of the website, and participant evaluation at enrollment and subsequently at 1, 3, and 12 months. Altogether, 2298 self-selected participants aged 16 years or older registered at the website between August 15, 2006 and December 7, 2007 and were randomly assigned to either a multicomponent, nontailored Internet-based intervention for smoking cessation (control) or a version of the same Internet-based intervention with tailored content delivered on the website and via email. Results: Of the randomly assigned participants, 116 (of 419, response rate = 27.7%) in the intervention group and 128 (of 428, response rate = 29.9%) in the control group had participated over the 12 months and responded at the end of follow-up. The 7-day intention-to-treat abstinence rate at 1 month was 15.2% (149/982) among those receiving the tailored intervention, compared with 9.4% (94/999) among those who received the nontailored intervention (P < .001). The corresponding figures at 3 months were 13.5% (122/902) and 9.4% (84/896, P =.006) and at 12 months were 11.2% (47/419) and 11.7% (50/428, P = .91). Likewise, the intervention group had higher self-efficacy and perceived tailoring at 1 and 3 months. Self-efficacy was found to partially mediate the effect of the intervention. Conclusion: Tailoring an Internet-based intervention for smoking cessation seems to increase the success rates in the short term, but not in the long term. %M 22169631 %R 10.2196/jmir.1605 %U http://www.jmir.org/2011/4/e121/ %U https://doi.org/10.2196/jmir.1605 %U http://www.ncbi.nlm.nih.gov/pubmed/22169631 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 4 %P e107 %T Evaluation of a Web-Based Intervention to Promote Hand Hygiene: Exploratory Randomized Controlled Trial %A Yardley,Lucy %A Miller,Sascha %A Schlotz,Wolff %A Little,Paul %+ Academic Unit of Psychology, Faculty of Human and Social Sciences, University of Southampton, Highfield, Southampton, SO17 1BJ, United Kingdom, 44 2380 59 4581, L.Yardley@soton.ac.uk %K Health promotion %K human influenza %K hand-washing %K randomized controlled trial %D 2011 %7 09.12.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Hand-washing is regarded as a potentially important behavior for preventing transmission of respiratory infection, particularly during a pandemic. Objective: The objective of our study was to evaluate whether a Web-based intervention can encourage more frequent hand-washing in the home, and to examine potential mediators and moderators of outcomes, as a necessary first step before testing effects of the intervention on infection rates in the PRIMIT trial (PRimary care trial of a website based Infection control intervention to Modify Influenza-like illness and respiratory infection Transmission). Methods: In a parallel-group pragmatic exploratory trial design, 517 nonblinded adults recruited through primary care were automatically randomly assigned to a fully automated intervention comprising 4 sessions of tailored motivational messages and self-regulation support (n = 324) or to a no-intervention control group (n = 179; ratio 2:1). Hand-washing frequency and theory of planned behavior cognitions relating to hand-washing were assessed by online questionnaires at baseline (in only half of the control participants, to permit evaluation of effects of baseline assessment on effect sizes), at 4 weeks (postintervention; all participants), and at 12 weeks. Results: Hand-washing rates in the intervention group were higher at 4 weeks than in the control group (mean 4.40, n = 285 and mean 4.04, n = 157, respectively; P < .001, Cohen d = 0.42) and remained higher at 12 weeks (mean 4.45, n = 282 and mean 4.12, n = 154, respectively; P < .001, Cohen d = 0.34). Hand-washing intentions and positive attitudes toward hand-washing increased more from baseline to 4 weeks in the intervention group than in the control group. Mediation analyses revealed positive indirect effects of the intervention on change in hand-washing via intentions (coefficient = .15, 95% confidence interval [CI], .08–.26) and attitudes (coefficient = 0.16, 95% CI, .09–.26). Moderator analyses confirmed that the intervention was similarly effective for men and women, those of higher and lower socioeconomic status, and those with higher and lower levels of perceived risk. Conclusions: This study provides promising evidence that Web-based interventions could potentially provide an effective method of promoting hand hygiene in the home. Data were collected during the 2010 influenza pandemic, when participants in both groups had already been exposed to extensive publicity about the need for hand hygiene, suggesting that our intervention could add to existing public health campaigns. However, further research is required to determine the effects of the intervention on actual infection rates. Trial: International Standard Randomized Controlled Trial Number (ISRCTN): 75058295; http://www.controlled-trials.com/ISRCTN75058295 (Archived by WebCite at http://www.webcitation.org/62KSbkNmm) %M 22155673 %R 10.2196/jmir.1963 %U http://www.jmir.org/2011/4/e107/ %U https://doi.org/10.2196/jmir.1963 %U http://www.ncbi.nlm.nih.gov/pubmed/22155673 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 4 %P e103 %T Effects of eHealth Interventions on Medication Adherence: A Systematic Review of the Literature %A Linn,Annemiek J %A Vervloet,Marcia %A van Dijk,Liset %A Smit,Edith G %A Van Weert,Julia CM %+ Netherlands Institute for Health Services Research, P.O. Box 1568, Utrecht, 3500 BN, Netherlands, 31 30 2729713, M.Vervloet@nivel.nl %K Internet interventions %K medication adherence %K compliance %K systematic review %K tailoring %K eHealth %K effects %K RCT %D 2011 %7 05.12.2011 %9 Review %J J Med Internet Res %G English %X Background: Since medication nonadherence is considered to be an important health risk, numerous interventions to improve adherence have been developed. During the past decade, the use of Internet-based interventions to improve medication adherence has increased rapidly. Internet interventions have the potential advantage of tailoring the interventions to the needs and situation of the patient. Objective: The main aim of this systematic review was to investigate which tailored Internet interventions are effective in improving medication adherence. Methods: We undertook comprehensive literature searches in PubMed, PsycINFO, EMBASE, CINAHL, and Communication Abstracts, following the guidelines of the Cochrane Collaboration. The methodological quality of the randomized controlled trials and clinical controlled trials and methods for measuring adherence were independently reviewed by two researchers. Results: A total of 13 studies met the inclusion criteria. All included Internet interventions clearly used moderately or highly sophisticated computer-tailored methods. Data synthesis revealed that there is evidence for the effectiveness of Internet interventions in improving medication adherence: 5 studies (3 high-quality studies and 2 low-quality studies) showed a significant effect on adherence; 6 other studies (4 high-quality studies and 2 low-quality studies) reported a moderate effect on adherence; and 2 studies (1 high-quality study and 1 low-quality study) showed no effect on patients’ adherence. However, most studies used self-reported measurements to assess adherence, which is generally perceived as a low-quality measurement. In addition, we did not find a clear relationship between the quality of the studies or the level of sophistication of message tailoring and the effectiveness of the intervention. This might be explained by the great difference in study designs and the way of measuring adherence, which makes results difficult to compare. There was also large variation in the measured interval between baseline and follow-up measurements. Conclusion: This review shows promising results on the effectiveness of Internet interventions to enhance patients’ adherence to prescribed long-term medications. Although there is evidence according to the data synthesis, the results must be interpreted with caution due to low-quality adherence measurements. Future studies using high-quality measurements to assess medication adherence are recommended to establish more robust evidence for the effectiveness of eHealth interventions on medication adherence. %M 22138112 %R 10.2196/jmir.1738 %U http://www.jmir.org/2011/4/e103/ %U https://doi.org/10.2196/jmir.1738 %U http://www.ncbi.nlm.nih.gov/pubmed/22138112 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 4 %P e100 %T Web-Based Risk Communication and Planning in an Obese Population: Exploratory Study %A Soureti,Anastasia %A Murray,Peter %A Cobain,Mark %A van Mechelen,Willem %A Hurling,Robert %+ Unilever Discover, Colworth Science Park, Sharnbrook, Bedfordshire, MK44 1LQ, United Kingdom, 44 1234248189 ext 8189, natasha.soureti@unilever.com %K Risk perceptions %K cardiovascular disease %K planning %K saturated fat intake %D 2011 %7 24.11.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: A healthy diet, low in saturated fat and high in fiber, is a popular medical recommendation in preventing cardiovascular disease (CVD). One approach to motivating healthier eating is to raise individuals’ awareness of their CVD risk and then help them form specific plans to change. Objectives: The aim was to explore the combined impact of a Web-based CVD risk message and a fully automated planning tool on risk perceptions, intentions, and saturated fat intake changes over 4 weeks. Methods: Of the 1187 men and women recruited online, 781 were randomly allocated to one of four conditions: a CVD risk message, the same CVD risk message paired with planning, planning on its own, and a control group. All outcome measures were assessed by online self-reports. Generalized linear modeling was used to analyze the data. Results: Self-perceived consumption of low saturated fat foods (odds ratio 11.40, 95% CI 1.86–69.68) and intentions to change diet (odds ratio 21.20, 95% CI 2.6–172.4) increased more in participants allocated to the planning than the control group. No difference was observed between the four conditions with regard to percentage saturated fat intake changes. Contrary to our expectations, there was no difference in perceived and percentage saturated fat intake change between the CVD risk message plus planning group and the control group. Risk perceptions among those receiving the CVD risk message changed to be more in line with their age (change in slopeindividual = 0.075, P = .01; change in slopecomparative = 0.100, P = .001), whereas there was no change among those who did not receive the CVD risk message. Conclusion: There was no evidence that combining a CVD risk message with a planning tool reduces saturated fat intake more than either alone. Further research is required to identify ways in which matching motivational and volitional strategies can lead to greater behavior changes. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 91154001; http://www.controlled-trials.com/ISRCTN91154001 (Archived by WebCite at http://www.webcitation.org/62sBoGeOO) %M 22126827 %R 10.2196/jmir.1579 %U http://www.jmir.org/2011/4/e100/ %U https://doi.org/10.2196/jmir.1579 %U http://www.ncbi.nlm.nih.gov/pubmed/22126827 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 4 %P e99 %T Improvement of Physical Activity by a Kiosk-based Electronic Screening and Brief Intervention in Routine Primary Health Care: Patient-Initiated Versus Staff-Referred %A Leijon,Matti %A Arvidsson,Daniel %A Nilsen,Per %A Stark Ekman,Diana %A Carlfjord,Siw %A Andersson,Agneta %A Johansson,Anne Lie %A Bendtsen,Preben %+ Center for Primary Health Care Research, Lund University/Region Skåne, CRC, building 28, floor 11, entrance 72, SUS Malmö, Malmö, 205 02, Sweden, 46 40 391 379, matti.leijon@med.lu.se %K Computer-tailored %K eHealth %K lifestyle behavior %K exercise %K automated %D 2011 %7 22.11.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Interactive behavior change technology (eg, computer programs, Internet websites, and mobile phones) may facilitate the implementation of lifestyle behavior interventions in routine primary health care. Effective, fully automated solutions not involving primary health care staff may offer low-cost support for behavior change. Objectives: We explored the effectiveness of an electronic screening and brief intervention (e-SBI) deployed through a stand-alone information kiosk for promoting physical activity among sedentary patients in routine primary health care. We further tested whether its effectiveness differed between patients performing the e-SBI on their own initiative and those referred to it by primary health care staff. Methods: The e-SBI screens for the physical activity level, motivation to change, attitudes toward performing the test, and physical characteristics and provides tailored feedback supporting behavior change. A total of 7863 patients performed the e-SBI from 2007 through 2009 in routine primary health care in Östergötland County, Sweden. Of these, 2509 were considered not sufficiently physically active, and 311 of these 2509 patients agreed to participate in an optional 3-month follow-up. These 311 patients were included in the analysis and were further divided into two groups based on whether the e-SBI was performed on the patient´s own initiative (informed by posters in the waiting room) or if the patient was referred to it by staff. A physical activity score representing the number of days being physically active was compared between baseline e-SBI and the 3-month follow-up. Based on physical activity recommendations, a score of 5 was considered the cutoff for being sufficiently physically active. Results: In all, 137 of 311 patients (44%) were sufficiently physically active at the 3-month follow-up. The proportion becoming sufficiently physically active was 16/55 (29%), 40/101 (40%), and 81/155 (52%) for patients with a physical activity score at baseline of 0, 1 to 2, and 3 to 4, respectively. The patient-initiated group and staff-referred group had similar mean physical activity scores at baseline (2.1, 95% confidence interval [CI] 1.8-2.3, versus 2.3, 95% CI 2.1-2.5) and at follow-up, (4.1, 95% CI 3.4-4.7, vs 4.2, 95% CI 3.7-4.8). Conclusions: Among the sedentary patients in primary health care who participated in the follow-up, the e-SBI appeared effective at promoting short-term improvement of physical activity for about half of them. The results were similar when the e-SBI was patient-initiated or staff-referred. The e-SBI may be a low-cost complement to lifestyle behavior interventions in routine primary health care and could work as a stand-alone technique not requiring the involvment of primary health care staff. %M 22107702 %R 10.2196/jmir.1745 %U http://www.jmir.org/2011/4/e99/ %U https://doi.org/10.2196/jmir.1745 %U http://www.ncbi.nlm.nih.gov/pubmed/22107702 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 4 %P e88 %T Health Promotion in the Workplace: Assessing Stress and Lifestyle With an Intranet Tool %A Lucini,Daniela %A Solaro,Nadia %A Lesma,Alessandro %A Gillet,Veronique Bernadette %A Pagani,Massimo %+ Centro di ricerca sulla Terapia Neurovegetativa e Medicina dell’Esercizio, Dipartimento Scienze Cliniche, Università degli Studi di Milano, Via G B Grassi 74, Milan, 20157, Italy, 39 0239042748, daniela.lucini@ctnv.unimi.it %K Stress %K lifestyle %K risk factor %K prevention %K web-based questionnaire %D 2011 %7 08.11.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic noncommunicable conditions, particularly cardiovascular and metabolic diseases, are the major causes of death and morbidity in both industrialized and low- to middle-income countries. Recent epidemiological investigations suggest that management of lifestyle factors, such as stress and lack of physical activity, could have an important value in cardiometabolic conditions, while information technology tools could play a significant facilitatory role. Objectives: The objective of our study was to verify the feasibility of using a private website, directed to the workers of a major Italian company, to describe their health profile and lifestyle and work habits using an ad hoc self-administered questionnaire. Methods: We administered anonymous multiple choice Web-based questionnaires to 945 participants (683 completed the task) as part of an ongoing health promotion program in a multinational company. Qualitative and quantitative data were synthesized with nonlinear principal component analysis to construct indicators (ie, variables) for stress, control, and lifestyle domains. Considering in addition absenteeism, the Calinski-Harabasz statistic and cluster analysis jointly differentiated seven clusters, which displayed different distributions of standardized classification variables. The final step consisted in assessing the relationship of the resulting seven subject typologies with personal data, illnesses, and metabolic syndrome status, carried out for the most part with descriptive methods. Results: Statistical analyses singled out two not-overlapping domains of stress and control, as well as three not-overlapping domains of physical activity, smoking, and alcohol habits. The centroids of the seven clusters generated by the procedure were significantly (P < .001) different considering all possible 21 comparisons between couples of groups. Percentage distributions of variables describing personal information (gender, age group, work category, illness status, or metabolic syndrome) within participant typologies show some noteworthy findings: females, workers aged 35–44 years, junior white collar workers, and respondents reporting illness were more prevalent in the stress group than in the overall studied population; preclinical metabolic syndrome status was more prevalent in the group with higher alcohol consumption. Absentees reported more illness. Conclusions: The present Intranet-based study shows the potential of applying diverse statistical techniques to deal jointly with qualitative and quantitative self-reported data. The resulting formal description of subject typologies and their relationship with personal characteristics might provide a convenient tool for supporting health promotion in the work environment. %M 22068357 %R 10.2196/jmir.1798 %U http://www.jmir.org/2011/4/e88/ %U https://doi.org/10.2196/jmir.1798 %U http://www.ncbi.nlm.nih.gov/pubmed/22068357 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 4 %P e89 %T Anxiety Online—A Virtual Clinic: Preliminary Outcomes Following Completion of Five Fully Automated Treatment Programs for Anxiety Disorders and Symptoms %A Klein,Britt %A Meyer,Denny %A Austin,David William %A Kyrios,Michael %+ National eTherapy Centre, Faculty of Life and Social Sciences, Swinburne University, Mail H99, PO Box 218, Hawthorn, Melbourne, 3122, Australia, 61 392148851, bklein@swin.edu.au %K eTherapy %K Internet interventions %K e-mental health %K cognitive behavior therapy %K generalized anxiety disorder %K panic disorder %K obsessive compulsive disorder %K social anxiety disorder %K posttraumatic stress disorder %K self-help %K fully automated %K Web treatment %D 2011 %7 04.11.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: The development of e-mental health interventions to treat or prevent mental illness and to enhance wellbeing has risen rapidly over the past decade. This development assists the public in sidestepping some of the obstacles that are often encountered when trying to access traditional face-to-face mental health care services. Objective: The objective of our study was to investigate the posttreatment effectiveness of five fully automated self-help cognitive behavior e-therapy programs for generalized anxiety disorder (GAD), panic disorder with or without agoraphobia (PD/A), obsessive–compulsive disorder (OCD), posttraumatic stress disorder (PTSD), and social anxiety disorder (SAD) offered to the international public via Anxiety Online, an open-access full-service virtual psychology clinic for anxiety disorders. Methods: We used a naturalistic participant choice, quasi-experimental design to evaluate each of the five Anxiety Online fully automated self-help e-therapy programs. Participants were required to have at least subclinical levels of one of the anxiety disorders to be offered the associated disorder-specific fully automated self-help e-therapy program. These programs are offered free of charge via Anxiety Online. Results: A total of 225 people self-selected one of the five e-therapy programs (GAD, n = 88; SAD, n = 50; PD/A, n = 40; PTSD, n = 30; OCD, n = 17) and completed their 12-week posttreatment assessment. Significant improvements were found on 21/25 measures across the five fully automated self-help programs. At postassessment we observed significant reductions on all five anxiety disorder clinical disorder severity ratings (Cohen d range 0.72–1.22), increased confidence in managing one’s own mental health care (Cohen d range 0.70–1.17), and decreases in the total number of clinical diagnoses (except for the PD/A program, where a positive trend was found) (Cohen d range 0.45–1.08). In addition, we found significant improvements in quality of life for the GAD, OCD, PTSD, and SAD e-therapy programs (Cohen d range 0.11–0.96) and significant reductions relating to general psychological distress levels for the GAD, PD/A, and PTSD e-therapy programs (Cohen d range 0.23–1.16). Overall, treatment satisfaction was good across all five e-therapy programs, and posttreatment assessment completers reported using their e-therapy program an average of 395.60 (SD 272.2) minutes over the 12-week treatment period. Conclusions: Overall, all five fully automated self-help e-therapy programs appear to be delivering promising high-quality outcomes; however, the results require replication. Trial Registration: Australian and New Zealand Clinical Trials Registry ACTRN121611000704998; http://www.anzctr.org.au/trial_view.aspx?ID=336143 (Archived by WebCite at http://www.webcitation.org/618r3wvOG) %M 22057287 %R 10.2196/jmir.1918 %U http://www.jmir.org/2011/4/e89/ %U https://doi.org/10.2196/jmir.1918 %U http://www.ncbi.nlm.nih.gov/pubmed/22057287 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 4 %P e87 %T Development of an Interactive, Web-Delivered System to Increase Provider–Patient Engagement in Smoking Cessation %A Sadasivam,Rajani S %A Delaughter,Kathryn %A Crenshaw,Katie %A Sobko,Heather J %A Williams,Jessica H %A Coley,Heather L %A Ray,Midge N %A Ford,Daniel E %A Allison,Jeroan J %A Houston,Thomas K %+ Division of Health Informatics and Implementation Science, Quantitative Health Sciences, University of Massachusetts Medical School, 55 Lake Ave North, Worcester, MA, 01545, United States, 1 508 856 8923, rajani.sadasivam@umassmed.edu %K Smoking cessation %K general practice %K family practice %K public health informatics %K user interfaces %K randomized controlled trial %K health services research %K web-based services %D 2011 %7 18.10.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Patient self-management interventions for smoking cessation are effective but underused. Health care providers do not routinely refer smokers to these interventions. Objective: The objective of our study was to uncover barriers and facilitators to the use of an e-referral system that will be evaluated in a community-based randomized trial. The e-referral system will allow providers to refer smokers to an online smoking intervention during routine clinical care. Methods: We devised a four-step development and pilot testing process: (1) system conceptualization using Delphi to identify key functionalities that would overcome barriers in provider referrals for smoking cessation, (2) Web system programming using agile software development and best programming practices with usability refinement using think-aloud testing, (3) implementation planning using the nominal group technique for the effective integration of the system into the workflow of practices, and (4) pilot testing to identify practice recruitment and system-use barriers in real-world settings. Results: Our Delphi process (step 1) conceptualized three key e-referral functions: (1) Refer Your Smokers, allowing providers to e-refer patients at the point of care by entering their emails directly into the system, (2) practice reports, providing feedback regarding referrals and impact of smoking-cessation counseling, and (3) secure messaging, facilitating provider–patient communication. Usability testing (step 2) suggested the system was easy to use, but implementation planning (step 3) suggested several important approaches to encourage use (eg, proactive email cues to encourage practices to participate). Pilot testing (step 4) in 5 practices had limited success, with only 2 patients referred; we uncovered important recruitment and system-use barriers (eg, lack of study champion, training, and motivation, registration difficulties, and forgetting to refer). Conclusions: Implementing a system to be used in a clinical setting is complex, as several issues can affect system use. In our ongoing large randomized trial, preliminary analysis with the first 50 practices using the system for 3 months demonstrated that our rigorous preimplementation evaluation helped us successfully identify and overcome these barriers before the main trial. Trial: Clinicaltrials.gov NCT00797628; http://clinicaltrials.gov/ct2/show/NCT00797628 (Archived by WebCite at http://www.webcitation.org/61feCfjCy) %M 22011394 %R 10.2196/jmir.1721 %U http://www.jmir.org/2011/4/e87/ %U https://doi.org/10.2196/jmir.1721 %U http://www.ncbi.nlm.nih.gov/pubmed/22011394 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 4 %P e83 %T Weight Change in a Commercial Web-Based Weight Loss Program and its Association With Website Use: Cohort Study %A Neve,Melinda %A Morgan,Philip J %A Collins,Clare E %+ School of Health Sciences, Faculty of Health, University of Newcastle, Priority Research Centre for Physical Activity and Nutrition, Advanced Technology Centre (Level 3), University Drive, Callaghan, NSW, NSW, Australia, 61 61 2 49215405, melinda.neve@newcastle.edu.au %K Weight loss %K obesity %K intervention %K Internet %K commercial %D 2011 %7 12.10.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: There is a paucity of information in the scientific literature on the effectiveness of commercial weight loss programs, including Web-based programs. The potential of Web-based weight loss programs has been acknowledged, but their ability to achieve significant weight loss has not been proven. Objective: The objectives were to evaluate the weight change achieved within a large cohort of individuals enrolled in a commercial Web-based weight loss program for 12 or 52 weeks and to describe participants’ program use in relation to weight change. Method: Participants enrolled in an Australian commercial Web-based weight loss program from August 15, 2007, through May 31, 2008. Self-reported weekly weight records were used to determine weight change after 12- and 52-week subscriptions. The primary analysis estimated weight change using generalized linear mixed models (GLMMs) for all participants who subscribed for 12 weeks and also for those who subscribed for 52 weeks. A sensitivity analysis was conducted using the last observation carried forward (LOCF) method. Website use (ie, the number of days participants logged on, made food or exercise entries to the Web-based diary, or posted to the discussion forum) was described from program enrollment to 12 and 52 weeks, and differences in website use by percentage weight change category were tested using Kruskal-Wallis test for equality of populations. Results: Participants (n = 9599) had a mean (standard deviation [SD]) age of 35.7 (9.5) years and were predominantly female (86% or 8279/9599) and obese (61% or 5866/9599). Results from the primary GLMM analysis including all enrollees found the mean percentage weight change was −6.2% among 12-week subscribers (n = 6943) and −6.9% among 52-week subscribers (n = 2656). Sensitivity analysis using LOCF revealed an average weight change of −3.0% and −3.5% after 12 and 52 weeks respectively. The use of all website features increased significantly (P < .01) as percentage weight change improved. Conclusions: The weight loss achieved by 12- and 52-week subscribers of a commercial Web-based weight loss program is likely to be in the range of the primary and sensitivity analysis results. While this suggests that, on average, clinically important weight loss may be achieved, further research is required to evaluate the efficacy of this commercial Web-based weight loss program prospectively using objective measures. The potential association between greater website use and increased weight loss also requires further evaluation, as strategies to improve participants’ use of Web-based program features may be required. %M 21993231 %R 10.2196/jmir.1756 %U http://www.jmir.org/2011/4/e83/ %U https://doi.org/10.2196/jmir.1756 %U http://www.ncbi.nlm.nih.gov/pubmed/21993231 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 3 %P e71 %T Factors Influencing the Use of a Web-Based Application for Supporting the Self-Care of Patients with Type 2 Diabetes: A Longitudinal Study %A Nijland,Nicol %A van Gemert-Pijnen,Julia EWC %A Kelders,Saskia M %A Brandenburg,Bart J %A Seydel,Erwin R %+ Department of Psychology, Health and Technology/Center for eHealth Research and Disease Management, Faculty of Behavioural Sciences, University of Twente, Drienerlolaan 5, PO Box 217, Enschede, 7500 AE, Netherlands, 31 651071559, n.nijland@utwente.nl %K Internet %K technology %K eHealth %K email %K communication %K primary care %K self-care %K diabetes %D 2011 %7 30.09.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: The take-up of eHealth applications in general is still rather low and user attrition is often high. Only limited information is available about the use of eHealth technologies among specific patient groups. Objective: The aim of this study was to explore the factors that influence the initial and long-term use of a Web-based application (DiabetesCoach) for supporting the self-care of patients with type 2 diabetes. Methods: A mixed-methods research design was used for a process analysis of the actual usage of the Web application over a 2-year period and to identify user profiles. Research instruments included log files, interviews, usability tests, and a survey. Results: The DiabetesCoach was predominantly used for interactive features like online monitoring, personal data, and patient–nurse email contact. It was the continuous, personal feedback that particularly appealed to the patients; they felt more closely monitored by their nurse and encouraged to play a more active role in self-managing their disease. Despite the positive outcomes, usage of the Web application was hindered by low enrollment and nonusage attrition. The main barrier to enrollment had to do with a lack of access to the Internet (146/226, 65%). Although 68% (34/50) of the enrollees were continuous users, of whom 32% (16/50) could be defined as hardcore users (highly active), the remaining 32% (16/50) did not continue using the Web application for the full duration of the study period. Barriers to long-term use were primarily due to poor user-friendliness of the Web application (the absence of “push” factors or reminders) and selection of the “wrong” users; the well-regulated patients were not the ones who could benefit the most from system use because of a ceiling effect. Patients with a greater need for care seemed to be more engaged in long-term use; highly active users were significantly more often medication users than low/inactive users (P = .005) and had a longer diabetes duration (P = .03). Conclusion: Innovations in health care will diffuse more rapidly when technology is employed that is simple to use and has applicable components for interactivity. This would foresee the patients’ need for continuous and personalized feedback, in particular for patients with a greater need for care. From this study several factors appear to influence increased use of eHealth technologies: (1) avoiding selective enrollment, (2) making use of participatory design methods, and (3) developing push factors for persistence. Further research should focus on the causal relationship between using the system’s features and actual usage, as such a view would provide important evidence on how specific technology features can engage and captivate users. %M 21959968 %R 10.2196/jmir.1603 %U http://www.jmir.org/2011/3/e71/ %U https://doi.org/10.2196/jmir.1603 %U http://www.ncbi.nlm.nih.gov/pubmed/21959968 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 3 %P e73 %T Bringing Loyalty to E-health: Theory Validation Using Three Internet-Delivered Interventions %A Crutzen,Rik %A Cyr,Dianne %A de Vries,Nanne K %+ Maastricht University/CAPHRI, P.O. Box 616, Maastricht, 6200MD, Netherlands, 31 433882828, rik.crutzen@maastrichtuniversity.nl %K e-Loyalty %K adherence %K attrition %K user perceptions %K theory %K Internet %K interventions %D 2011 %7 24.09.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-delivered interventions can effectively change health risk behaviors, but the actual use of these interventions by the target group once they access the website is often very low (high attrition, low adherence). Therefore, it is relevant and necessary to focus on factors related to use of an intervention once people arrive at the intervention website. We focused on user perceptions resulting in e-loyalty (ie, intention to visit an intervention again and to recommend it to others). A background theory for e-loyalty, however, is still lacking for Internet-delivered interventions. Objective: The objective of our study was to propose and validate a conceptual model regarding user perceptions and e-loyalty within the field of eHealth. Methods: We presented at random 3 primary prevention interventions aimed at the general public and, subsequently, participants completed validated measures regarding user perceptions and e-loyalty. Time on each intervention website was assessed by means of server registrations. Results: Of the 592 people who were invited to participate, 397 initiated the study (response rate: 67%) and 351 (48% female, mean age 43 years, varying in educational level) finished the study (retention rate: 88%). Internal consistency of all measures was high (Cronbach alpha > .87). The findings demonstrate that the user perceptions regarding effectiveness (betarange .21–.41) and enjoyment (betarange .14–.24) both had a positive effect on e-loyalty, which was mediated by active trust (betarange .27–.60). User perceptions and e-loyalty had low correlations with time on the website (rrange .04–.18). Conclusions: The consistent pattern of findings speaks in favor of their robustness and contributes to theory validation regarding e-loyalty. The importance of a theory-driven solution to a practice-based problem (ie, low actual use) needs to be stressed in view of the importance of the Internet in terms of intervention development. Longitudinal studies are needed to investigate whether people will actually revisit intervention websites and whether this leads to changes in health risk behaviors. %M 21946128 %R 10.2196/jmir.1837 %U http://www.jmir.org/2011/3/e73/ %U https://doi.org/10.2196/jmir.1837 %U http://www.ncbi.nlm.nih.gov/pubmed/21946128 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 3 %P e58 %T Using the Internet to Understand Smokers’ Treatment Preferences: Informing Strategies to Increase Demand %A Westmaas,J Lee %A Abroms,Lorien %A Bontemps-Jones,Jeuneviette %A Bauer,Joseph E %A Bade,Jeanine %+ Behavioral Research Center, American Cancer Society, 250 Williams St., Atlanta, GA, 30303, United States, 1 404 329 7730 ext 7730, lee.westmaas@cancer.org %K Consumer demand %K pharmacotherapy %K quitline counseling %K smoking cessation %K social support %D 2011 %7 26.08.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Most smokers attempt to quit on their own even though cessation aids can substantially increase their chances of success. Millions of smokers seek cessation advice on the Internet, so using it to promote cessation products and services is one strategy for increasing demand for treatments. Little is known, however, about what cessation aids these smokers would find most appealing or what predicts their preferences (eg, age, level of dependence, or timing of quit date). Objective: The objective of our study was to gain insight into how Internet seekers of cessation information make judgments about their preferences for treatments, and to identify sociodemographic and other predictors of preferences. Methods: An online survey assessing interest in 9 evidence-based cessation products and services was voluntarily completed by 1196 smokers who visited the American Cancer Society’s Great American Smokeout (GASO) webpage. Cluster analysis was conducted on ratings of interest. Results: In total, 48% (572/1196) of respondents were “quite a bit” or “very much” interested in nicotine replacement therapy (NRT), 45% (534/1196) in a website that provides customized quitting advice, and 37% (447/1196) in prescription medications. Only 11.5% (138/1196) indicated similar interest in quitlines, and 17% (208/1196) in receiving customized text messages. Hierarchical agglomerative cluster analysis revealed that interest in treatments formed 3 clusters: interpersonal–supportive methods (eg, telephone counseling, Web-based peer support, and in-person group programs), nonsocial–informational methods (eg, Internet programs, tailored emails, and informational booklets), and pharmacotherapy (NRT, bupropion, and varenicline). Only 5% (60/1196) of smokers were “quite a bit” or “very much” interested in interpersonal–supportive methods compared with 25% (298/1196) for nonsocial–informational methods and 33% (399/1196) for pharmacotherapy. Multivariate analyses and follow-up comparisons indicated that level of interest in pharmacotherapy (“quite a bit or “very much” vs. “not at all”) varied as a function of education (n = 575, χ23 =16.6, P = .001), age (n = 528, χ23 = 8.2, P = .04), smoking level (n = 514, χ23 = 9.5, P = .02), and when smokers were planning to quit (n = 607, χ24 = 34.0, P < .001). Surprisingly, greater age was associated with stronger interest in nonsocial–informational methods (n = 367, χ23 = 10.8, P = .01). Interest in interpersonal–supportive methods was greater if smokers had used a quitline before (n = 259, χ21 = 18.3, P < .001), or were planning to quit earlier rather than later (n = 148, χ21 = 4.9, P = .03). Conclusions: Smokers accessing the Internet for information on quitting appear to differentiate cessation treatments by how much interpersonal interaction or support the treatment entails. Quitting date, smoking level, and sociodemographic variables can identify smokers with varying levels of interest in the 3 classes of cessation methods identified. These results can potentially be used to more effectively target and increase demand for these treatments among smokers searching the Internet for cessation information. %M 21873150 %R 10.2196/jmir.1666 %U http://www.jmir.org/2011/3/e58/ %U https://doi.org/10.2196/jmir.1666 %U http://www.ncbi.nlm.nih.gov/pubmed/21873150 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 3 %P e56 %T Modeling the Cost-Effectiveness of Health Care Systems for Alcohol Use Disorders: How Implementation of eHealth Interventions Improves Cost-Effectiveness %A Smit,Filip %A Lokkerbol,Joran %A Riper,Heleen %A Majo,Maria Cristina %A Boon,Brigitte %A Blankers,Matthijs %+ Trimbos Institute (Netherlands Institute of Mental Health and Addiction), Centre of Prevention and Brief Intervention, P.O. Box 725, Utrecht, 1400 AS, Netherlands, 31 629735268, fsmit@trimbos.nl %K Alcohol-related disorders %K early intervention %K health care systems %K cost-effectiveness %D 2011 %7 11.08.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Informing policy decisions about the cost-effectiveness of health care systems (ie, packages of clinical interventions) is probably best done using a modeling approach. To this end, an alcohol model (ALCMOD) was developed. Objective: The aim of ALCMOD is to estimate the cost-effectiveness of competing health care systems in curbing alcohol use at the national level. This is illustrated for scenarios where new eHealth technologies for alcohol use disorders are introduced in the Dutch health care system. Method: ALCMOD assesses short-term (12-month) incremental cost-effectiveness in terms of reductions in disease burden, that is, disability adjusted life years (DALYs) and health care budget impacts. Results: Introduction of new eHealth technologies would substantially increase the cost-effectiveness of the Dutch health care system for alcohol use disorders: every euro spent under the current system returns a value of about the same size (€ 1.08, ie, a “surplus” of 8 euro cents) while the new health care system offers much better returns on investment, that is, every euro spent generates € 1.62 in health-related value. Conclusion: Based on the best available evidence, ALCMOD's computations suggest that implementation of new eHealth technologies would make the Dutch health care system more cost-effective. This type of information may help (1) to identify opportunities for system innovation, (2) to set agendas for further research, and (3) to inform policy decisions about resource allocation. %M 21840836 %R 10.2196/jmir.1694 %U http://www.jmir.org/2011/3/e56/ %U https://doi.org/10.2196/jmir.1694 %U http://www.ncbi.nlm.nih.gov/pubmed/21840836 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 3 %P e52 %T A Systematic Review of the Impact of Adherence on the Effectiveness of e-Therapies %A Donkin,Liesje %A Christensen,Helen %A Naismith,Sharon L %A Neal,Bruce %A Hickie,Ian B %A Glozier,Nick %+ Brain & Mind Research Institute, The University of Sydney, 100 Mallet Street, Camperdown, NSW 2050, Australia, 61 293510520, Liesje.Donkin@sydney.edu.au %K Adherence %K persistence %K online therapy %K e-therapy %K systematic review %D 2011 %7 05.08.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: As the popularity of e-therapies grows, so too has the body of literature supporting their effectiveness. However, these interventions are often plagued by high attrition rates and varying levels of user adherence. Understanding the role of adherence may be crucial to understanding how program usage influences the effectiveness of e-therapy interventions. Objective: The aim of this study was to systematically review the e-therapy literature to (1) describe the methods used to assess adherence and (2) evaluate the association of adherence with outcome of these interventions. Methods: A systematic review of e-therapy interventions was conducted across disease states and behavioral targets. Data were collected on adherence measures, outcomes, and analyses exploring the relationship between adherence measures and outcomes. Results: Of 69 studies that reported an adherence measure, only 33 (48%) examined the relationship between adherence and outcomes. The number of logins was the most commonly reported measure of adherence, followed by the number of modules completed. The heterogeneity of adherence and outcome measures limited analysis. However, logins appeared to be the measure of adherence most consistently related to outcomes in physical health interventions, while module completion was found to be most related to outcomes in psychological health interventions. Conclusions: There is large variation in the reporting of adherence and the association of adherence with outcomes. A lack of agreement about how best to measure adherence is likely to contribute to the variation in findings. Physical and psychological outcomes seem influenced by different types of adherence. A composite measure encompassing time online, activity completion, and active engagements with the intervention may be the best measure of adherence. Further research is required to establish a consensus for measuring adherence and to understand the role of adherence in influencing outcomes. %M 21821503 %R 10.2196/jmir.1772 %U http://www.jmir.org/2011/3/e52/ %U https://doi.org/10.2196/jmir.1772 %U http://www.ncbi.nlm.nih.gov/pubmed/21821503 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 3 %P e46 %T Persuasive Features in Web-Based Alcohol and Smoking Interventions: A Systematic Review of the Literature %A Lehto,Tuomas %A Oinas-Kukkonen,Harri %+ Oulu Advanced Research on Software and Information Systems, Department of Information Processing Science, University of Oulu, Rakentajantie 3, Oulu, 90570, Finland, 358 8 553 1900, tuomas.lehto@oulu.fi %K Web-based %K online %K Internet %K alcohol %K smoking %K intervention %K behavior change %K persuasive %K PSD model %K review %D 2011 %7 22.07.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: In the past decade, the use of technologies to persuade, motivate, and activate individuals’ health behavior change has been a quickly expanding field of research. The use of the Web for delivering interventions has been especially relevant. Current research tends to reveal little about the persuasive features and mechanisms embedded in Web-based interventions targeting health behavior change. Objectives: The purpose of this systematic review was to extract and analyze persuasive system features in Web-based interventions for substance use by applying the persuasive systems design (PSD) model. In more detail, the main objective was to provide an overview of the persuasive features within current Web-based interventions for substance use. Methods: We conducted electronic literature searches in various databases to identify randomized controlled trials of Web-based interventions for substance use published January 1, 2004, through December 31, 2009, in English. We extracted and analyzed persuasive system features of the included Web-based interventions using interpretive categorization. Results: The primary task support components were utilized and reported relatively widely in the reviewed studies. Reduction, self-monitoring, simulation, and personalization seem to be the most used features to support accomplishing user’s primary task. This is an encouraging finding since reduction and self-monitoring can be considered key elements for supporting users to carry out their primary tasks. The utilization of tailoring was at a surprisingly low level. The lack of tailoring may imply that the interventions are targeted for too broad an audience. Leveraging reminders was the most common way to enhance the user-system dialogue. Credibility issues are crucial in website engagement as users will bind with sites they perceive credible and navigate away from those they do not find credible. Based on the textual descriptions of the interventions, we cautiously suggest that most of them were credible. The prevalence of social support in the reviewed interventions was encouraging. Conclusions: Understanding the persuasive elements of systems supporting behavior change is important. This may help users to engage and keep motivated in their endeavors. Further research is needed to increase our understanding of how and under what conditions specific persuasive features (either in isolation or collectively) lead to positive health outcomes in Web-based health behavior change interventions across diverse health contexts and populations. %M 21795238 %R 10.2196/jmir.1559 %U http://www.jmir.org/2011/3/e46/ %U https://doi.org/10.2196/jmir.1559 %U http://www.ncbi.nlm.nih.gov/pubmed/21795238 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 3 %P e48 %T A Systematic Review of Information and Communication Technology–Based Interventions for Promoting Physical Activity Behavior Change in Children and Adolescents %A Lau,Patrick WC %A Lau,Erica Y %A Wong,Del P %A Ransdell,Lynda %+ Department of Physical Education, Hong Kong Baptist University, DLB 643, David C. Lam Bldg,, Shaw Campus, HKBU, Hong Kong, 0000, China, 852 34115634, wclau@hkbu.edu.hk %K Internet %K email %K text messages %D 2011 %7 13.07.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: A growing body of research has employed information and communication technologies (ICTs) such as the Internet and mobile phones for disseminating physical activity (PA) interventions with young populations. Although several systematic reviews have documented the effects of ICT-based interventions on PA behavior, very few have focused on children and adolescents specifically. Objectives: The present review aimed to systematically evaluate the efficacy and methodological quality of ICT-based PA interventions for children and adolescents based on evidence from randomized controlled trials. Methods: Electronic databases Medline, PsycInfo, CINAHL, and Web of Science were searched to retrieve English language articles published in international academic peer-reviewed journals from January 1, 1997, through December 31, 2009. Included were articles that provided descriptions of interventions designed to improve PA-related cognitive, psychosocial, and behavioral outcomes and that used randomized controlled trial design, included only children (6-12 years old) and adolescents (13-18 years old) in both intervention and control groups, and employed Internet, email, and/or short message services (SMS, also known as text messaging) as one or more major or assistive modes to deliver the intervention. Results: In total, 9 studies were analyzed in the present review. All studies were published after 2000 and conducted in Western countries. Of the 9 studies, 7 demonstrated positive and significant within-group differences in at least one psychosocial or behavioral PA outcome. In all, 3 studies reported positive and significant between-group differences favoring the ICT group. When between-group differences were compared across studies, effect sizes were small in 6 studies and large in 3 studies. With respect to methodological quality, 7 of the 9 studies had good methodological quality. Failure to report allocation concealment, blinding to outcome assessment, and lack of long-term follow-up were the criteria met by the fewest studies. In addition, 5 studies measured the intervention exposure rate and only 1 study employed objective measures to record data. Conclusion: The present review provides evidence supporting the positive effects of ICTs in PA interventions for children and adolescents, especially when used with other delivery approaches (ie, face-to-face). Because ICT delivery approaches are often mixed with other approaches and these studies sometimes lack a comparable control group, additional research is needed to establish the true independent effects of ICT as an intervention delivery mode. Although two-thirds of the studies demonstrated satisfactory methodological quality, several quality criteria should be considered in future studies: clear descriptions of allocation concealment and blinding of outcome assessment, extension of intervention duration, and employment of objective measures in intervention exposure rate. Due to the small number of studies that met inclusion criteria and the lack of consistent evidence, researchers should be cautious when interpreting the findings of the present review. %M 21749967 %R 10.2196/jmir.1533 %U http://www.jmir.org/2011/3/e48/ %U https://doi.org/10.2196/jmir.1533 %U http://www.ncbi.nlm.nih.gov/pubmed/21749967 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 2 %P e43 %T Curbing Alcohol Use in Male Adults Through Computer Generated Personalized Advice: Randomized Controlled Trial %A Boon,Brigitte %A Risselada,Anneke %A Huiberts,Annemarie %A Riper,Heleen %A Smit,Filip %+ Trimbos-institute, Department of Public Mental Health, POBox 725, Utrecht, 3500 AS, Netherlands, 31 302971145, bboon@trimbos.nl %K Web-based personalized feedback %K alcohol %K Internet %K heavy drinking %K problem drinking %K adult %D 2011 %7 30.06.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: In recent years, interventions that deliver online personalized feedback on alcohol use have been developed and appear to be a feasible way to curb heavy drinking. Randomized controlled trials (RCTs) among the general adult population, however, are scarce. The present study offers an RCT of Drinktest.nl, an online personalized feedback intervention in the Netherlands. Objective: The aim of this study was to assess the effectiveness of computer-based personalized feedback on heavy alcohol use in male adults. Methods: Randomization stratified by age and educational level was used to assign participants to either the intervention consisting of online personalized feedback or an information-only control condition. Participants were told as a cover story that they would evaluate newly developed health education materials. Participants were males (n = 450), aged 18 to 65 years, presenting with either heavy alcohol use (> 20 units of alcohol weekly) and/or binge drinking (> 5 units of alcohol at a single occasion at least 1 day per week) in the past 6 months. They were selected with a screener from a sampling frame of 25,000 households. The primary outcome measure was the percentage of the participants that had successfully reduced their drinking levels to below the Dutch guideline threshold for at-risk drinking. Results: Intention-to-treat analysis showed that in the experimental condition, 42% (97/230) of the participants were successful in reducing their drinking levels to below the threshold at the 1-month follow-up as compared with 31% (67/220) in the control group (odds ratio [OR] = 1.7, number needed to treat [NNT] = 8.6), which was statistically significant (χ21 = 6.67, P = .01). At the 6-month follow-up, the success rates were 46% (105/230) and 37% (82/220) in the experimental and control conditions, respectively (OR = 1.4, NNT = 11.9), but no longer statistically significant (χ21 = 3.25, P = .07). Conclusions: Personalized online feedback on alcohol consumption appears to be an effective and easy way to change unhealthy drinking patterns in adult men, at least in the short-term. Trial registration: International Standard Randomized Controlled Trial Number: NTR836; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=836 (Archived by WebCite at http://www.webcitation.org/5ytnEz2vp) %M 21719412 %R 10.2196/jmir.1695 %U http://www.jmir.org/2011/2/e43/ %U https://doi.org/10.2196/jmir.1695 %U http://www.ncbi.nlm.nih.gov/pubmed/21719412 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 2 %P e42 %T Effectiveness of E-Self-help Interventions for Curbing Adult Problem Drinking: A Meta-analysis %A Riper,Heleen %A Spek,Viola %A Boon,Brigitte %A Conijn,Barbara %A Kramer,Jeannet %A Martin-Abello,Katherina %A Smit,Filip %+ Department of Clinical Psychology, VU University Amsterdam, Van der Boechorststraat 1, Amsterdam, 1081 BT, Netherlands, 31 20 5988757, h.riper@psy.vu.nl %K Meta-analysis %K alcohol %K problem drinking %K randomized controlled trial %K self-help %K e-self-help %K intervention %K unguided self-help %K low intensity interventions %K Internet %K adults %D 2011 %7 30.06.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Self-help interventions without professional contact to curb adult problem drinking in the community are increasingly being delivered via the Internet. Objective: The objective of this meta-analysis was to assess the overall effectiveness of these eHealth interventions. Methods: In all, 9 randomized controlled trials (RCTs), all from high-income countries, with 9 comparison conditions and a total of 1553 participants, were identified, and their combined effectiveness in reducing alcohol consumption was evaluated by means of a meta-analysis. Results: An overall medium effect size (g = 0.44, 95% CI 0.17-0.71, random effect model) was found for the 9 studies, all of which compared no-contact interventions to control conditions. The medium effect was maintained (g = 0.39; 95% CI 0.23-0.57, random effect model) after exclusion of two outliers. Type of control group, treatment location, type of analysis, and sample size did not have differential impacts on treatment outcome. A significant difference (P = .04) emerged between single-session personalized normative feedback interventions (g = 0.27, 95% CI 0.11-0.43) and more extended e- self-help (g = 0.61, 95% CI 0.33-0.90). Conclusion: E-self-help interventions without professional contact are effective in curbing adult problem drinking in high-income countries. In view of the easy scalability and low dissemination costs of such interventions, we recommend exploration of whether these could broaden the scope of effective public health interventions in low- and middle-income countries as well. %M 21719411 %R 10.2196/jmir.1691 %U http://www.jmir.org/2011/2/e42/ %U https://doi.org/10.2196/jmir.1691 %U http://www.ncbi.nlm.nih.gov/pubmed/21719411 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 2 %P e39 %T A 5-Year Follow-up of Internet-Based Cognitive Behavior Therapy for Social Anxiety Disorder %A Hedman,Erik %A Furmark,Tomas %A Carlbring,Per %A Ljótsson,Brjánn %A Rück,Christian %A Lindefors,Nils %A Andersson,Gerhard %+ Department of Clinical Neuroscience, Karolinska Institutet, Internet Psychiatry M46, Karolinska University Hospital Huddinge, Stockholm, 141 86, Sweden, 46 8 585 857 91, erik.hedman.2@ki.se %K Internet %K cognitive behavior therapy %K anxiety disorders %K social anxiety disorder %K 5-year follow-up %D 2011 %7 15.06.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet-based cognitive behavior therapy (CBT) has been shown to be a promising method to disseminate cognitive behavior therapy for social anxiety disorder (SAD). Several trials have demonstrated that Internet-based CBT can be effective for SAD in the shorter term. However, the long-term effects of Internet-based CBT for SAD are less well known. Objective: Our objective was to investigate the effect of Internet-based CBT for SAD 5 years after completed treatment. Method: We conducted a 5-year follow-up study of 80 persons with SAD who had undergone Internet-based CBT. The assessment comprised a diagnostic interview and self-report questionnaires. The main outcome measure was the Liebowitz Social Anxiety Scale-Self-Report (LSAS-SR). Additional measures of social anxiety were the Social Interaction Anxiety Scale (SIAS) and the Social Phobia Scale (SPS). Attrition rates were low: 89% (71/80) of the participants completed the diagnostic interview and 80% (64/80) responded to the questionnaires. Results: Mixed-effect models analysis showed a significant effect of time on the three social anxiety measures, LSAS-SR, SIAS, and SPS (F3,98-102 = 16.05 - 29.20, P < .001) indicating improvement. From baseline to 5-year follow-up, participants’ mean scores on the LSAS-SR were reduced from 71.3 (95% confidence interval [CI] 66.1-76.5) to 40.3 (95% CI 35.2 - 45.3). The effect sizes of the LSAS-SR were large (Cohen’s d range 1.30 - 1.40, 95% CI 0.77 - 1.90). Improvements gained at the 1-year follow-up were sustained 5 years after completed treatment. Conclusions: Internet-based CBT for SAD is a treatment that can result in large and enduring effects. Trial registration: Clinicaltrials.gov NCT01145690; http://clinicaltrials.gov/ct2/show/NCT01145690 (Archived by WebCite at http://www.webcitation.org/5ygRxDLfK) %M 21676694 %R 10.2196/jmir.1776 %U http://www.jmir.org/2011/2/e39/ %U https://doi.org/10.2196/jmir.1776 %U http://www.ncbi.nlm.nih.gov/pubmed/21676694 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 2 %P e34 %T Effects of a Multilingual Information Website Intervention on the Levels of Depression Literacy and Depression-Related Stigma in Greek-Born and Italian-Born Immigrants Living in Australia: A Randomized Controlled Trial %A Kiropoulos,Litza A %A Griffiths,Kathleen M %A Blashki,Grant %+ The University of Melbourne, Psychological Sciences, The University of Melbourne Psychology Clinic, 14-20 Blackwood Street, University of Melbourne, Melbourne, 3010, Australia, 61 3 9035 4063, litzak@unimelb.edu.au %K Depression literacy %K depression-related stigma %K immigrants %K Internet-based interventions %K depression %K randomized control trial %D 2011 %7 19.04.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Little is known about the efficacy of Internet-based information interventions in increasing depression literacy or reducing depression stigma and depressive symptoms in people from non–English-speaking backgrounds. Objective: Our objective was to investigate the effects of Multicultural Information on Depression Online (MIDonline), an Internet-based multilingual depression-specific information resource, on depression literacy, depression stigma, and depressive symptoms in Greek-born and Italian-born immigrants to Australia. Method: In all, 202 Greek- and Italian-born immigrants aged 48 to 88 years were randomly allocated to an online depression information intervention (n =110) or a depression interview control group (n = 92). Participants allocated to the information intervention only had access to the website during the 1- to 1.5-hour intervention session. The primary outcome measures were depression literacy (depression knowledge), personal stigma (personal stigma toward people with a mental illness), perceived stigma (participants’ views about the probable attitude of the general community toward people with mental illness), and depressive symptoms. Depression literacy, personal and perceived stigma, and depressive symptoms were assessed at preassessment, postassessment, and at a 1-week follow-up assessment. The trial was undertaken at Monash University, Melbourne, Australia. Randomization and allocation to trial group were carried out using a computer-generated table. Results: For depression literacy, there was a significant difference between the MIDonline and the control group with those in the MIDonline intervention displaying higher depression literacy scores postassessment (F1,178 = 144.99, P < .001) and at the follow-up assessment (F1,178 = 129.13, P < .001) than those in the control group. In addition, those in the MIDonline intervention showed a significantly greater decrease in mean personal stigma scores postassessment (F1,178 = 38.75, P < .001) and at the follow-up assessment (F1,176 = 11.08, P = .001) than those in the control group. For perceived stigma, there was no significant difference between the MIDonline intervention and the control group at postassessment (F1,178 = 0.60, P = .44) and at the follow-up assessment (F1,176 = 1.06, P = .30). For level of depression, there was no significant difference between the MIDonline intervention and the control group at preassessment (F1,201 = 0.56, P = .45), postassessment (F1,178 = 0.03, P = .86), or at the follow-up assessment, (F1,175 = 1.71, P = .19). Within group effect sizes for depression literacy were −1.78 (MIDonline) and −0.07 (control); for personal stigma, they were 0.83 (MIDonline) and 0.06 (control); for perceived stigma, they were 0.14 (MIDonline) and 0.16 (control); and for depressive symptoms, they were 0.10 (MIDonline) and 0.10 (control). Conclusions: Current results suggested that the Internet may be a feasible and effective means for increasing depression knowledge and decreasing personal stigma in non–English-speaking immigrant populations residing in English-speaking countries. The lack of change in perceived stigma in this trial is consistent with results in other trials examining online depression stigma interventions in English-speaking groups. Trial Registration: ISRCTN76460837; http://www.controlled-trials.com/ISRCTN76460837 (Archived by WebCite at http://www.webcitation.org/5xjxva4Uq) %M 21504872 %R 10.2196/jmir.1527 %U http://www.jmir.org/2011/2/e34/ %U https://doi.org/10.2196/jmir.1527 %U http://www.ncbi.nlm.nih.gov/pubmed/21504872 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 2 %P e32 %T Effectiveness of a Web-based Intervention Aimed at Healthy Dietary and Physical Activity Behavior: A Randomized Controlled Trial About Users and Usage %A Kelders,Saskia M %A Van Gemert-Pijnen,Julia E.W.C %A Werkman,Andrea %A Nijland,Nicol %A Seydel,Erwin R %+ Department of Psychology, Health and Technology, Faculty of Behavioural Sciences, University of Twente, CI H403, PO Box 217, Enschede, 7500 AE, Netherlands, 31 6 51070689, s.m.kelders@utwente.nl %K Randomized controlled trial %K usage %K eHealth %K intervention %K attrition %K Internet %K adherence %K retention %D 2011 %7 14.04.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Recent studies have shown the potential of Web-based interventions for changing dietary and physical activity (PA) behavior. However, the pathways of these changes are not clear. In addition, nonusage poses a threat to these interventions. Little is known of characteristics of participants that predict usage. Objective: In this study we investigated the users and effect of the Healthy Weight Assistant (HWA), a Web-based intervention aimed at healthy dietary and PA behavior. We investigated the value of a proposed framework (including social and economic factors, condition-related factors, patient-related factors, reasons for use, and satisfaction) to predict which participants are users and which participants are nonusers. Additionally, we investigated the effectiveness of the HWA on the primary outcomes, self-reported dietary and physical activity behavior. Methods: Our design was a two-armed randomized controlled trial that compared the HWA with a waiting list control condition. A total of 150 participants were allocated to the waiting list group, and 147 participants were allocated to the intervention group. Online questionnaires were filled out before the intervention period started and after the intervention period of 12 weeks. After the intervention period, respondents in the waiting list group could use the intervention. Objective usage data was obtained from the application itself. Results: In the intervention group, 64% (81/147) of respondents used the HWA at least once and were categorized as “users.” Of these, 49% (40/81) used the application only once. Increased age and not having a chronic condition increased the odds of having used the HWA (age: beta = 0.04, P = .02; chronic condition: beta = 2.24, P = .003). Within the intervention group, users scored better on dietary behavior and on knowledge about healthy behavior than nonusers (self-reported diet: χ22 = 8.4, P = .02; knowledge: F1,125 = 4.194, P = .04). Furthermore, users underestimated their behavior more often than nonusers, and nonusers overestimated their behavior more often than users (insight into dietary behavior: χ22 = 8.2, P = .02). Intention-to-treat analyses showed no meaningful significant effects of the intervention. Exploratory analyses of differences between pretest and posttest scores of users, nonusers, and the control group showed that on dietary behavior only the nonusers significantly improved (effect size r = −.23, P = .03), while on physical activity behavior only the users significantly improved (effect size r = −.17, P = .03). Conclusions: Respondents did not use the application as intended. From the proposed framework, a social and economic factor (age) and a condition-related factor (chronic condition) predicted usage. Moreover, users were healthier and more knowledgeable about healthy behavior than nonusers. We found no apparent effects of the intervention, although exploratory analyses showed that choosing to use or not to use the intervention led to different outcomes. Combined with the differences between groups at baseline, this seems to imply that these groups are truly different and should be treated as separate entities. Trial registration: Trial ID number: ISRCTN42687923; http://www.controlled-trials.com/ISRCTN42687923/ (Archived by WebCite at http://www.webcitation.org/5xnGmvQ9Y) %M 21493191 %R 10.2196/jmir.1624 %U http://www.jmir.org/2011/2/e32/ %U https://doi.org/10.2196/jmir.1624 %U http://www.ncbi.nlm.nih.gov/pubmed/21493191 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 1 %P e28 %T Social Cognitive Determinants of Nutrition and Physical Activity Among Web-Health Users Enrolling in an Online Intervention: The Influence of Social Support, Self-Efficacy, Outcome Expectations, and Self-Regulation %A Anderson-Bill,Eileen Smith %A Winett,Richard A %A Wojcik,Janet R %+ Center for Research in Health Behavior, Department of Psychology, Virginia Tech, Mail Code 0274, 460 Turner Street. Suite 203, Blacksburg, VA, 24060, United States, 1 540 231 9805, eileen@vt.edu %K Internet users %K dietary habits %K physical activity %K psychosocial aspects %K self-efficacy %K social support %K self-regulation %D 2011 %7 17.03.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: The Internet is a trusted source of health information for growing majorities of Web users. The promise of online health interventions will be realized with the development of purely online theory-based programs for Web users that are evaluated for program effectiveness and the application of behavior change theory within the online environment. Little is known, however, about the demographic, behavioral, or psychosocial characteristics of Web-health users who represent potential participants in online health promotion research. Nor do we understand how Web users’ psychosocial characteristics relate to their health behavior—information essential to the development of effective, theory-based online behavior change interventions. Objective: This study examines the demographic, behavioral, and psychosocial characteristics of Web-health users recruited for an online social cognitive theory (SCT)-based nutrition, physical activity, and weight gain prevention intervention, the Web-based Guide to Health (WB-GTH). Methods: Directed to the WB-GTH site by advertisements through online social and professional networks and through print and online media, participants were screened, consented, and assessed with demographic, physical activity, psychosocial, and food frequency questionnaires online (taking a total of about 1.25 hours); they also kept a 7-day log of daily steps and minutes walked. Results: From 4700 visits to the site, 963 Web users consented to enroll in the study: 83% (803) were female, participants’ mean age was 44.4 years (SD 11.03 years), 91% (873) were white, and 61% (589) were college graduates; participants’ median annual household income was approximately US $85,000. Participants’ daily step counts were in the low-active range (mean 6485.78, SD 2352.54) and overall dietary levels were poor (total fat g/day, mean 77.79, SD 41.96; percent kcal from fat, mean 36.51, SD 5.92; fiber g/day, mean 17.74, SD 7.35; and fruit and vegetable servings/day, mean 4.03, SD 2.33). The Web-health users had good self-efficacy and outcome expectations for health behavior change; however, they perceived little social support for making these changes and engaged in few self-regulatory behaviors. Consistent with SCT, theoretical models provided good fit to Web-users’ data (root mean square error of the approximation [RMSEA] < .05). Perceived social support and use of self-regulatory behaviors were strong predictors of physical activity and nutrition behavior. Web users’ self-efficacy was also a good predictor of healthier levels of physical activity and dietary fat but not of fiber, fruits, and vegetables. Social support and self-efficacy indirectly predicted behavior through self-regulation, and social support had indirect effects through self-efficacy. Conclusions: Results suggest Web-health users visiting and ultimately participating in online health interventions may likely be middle-aged, well-educated, upper middle class women whose detrimental health behaviors put them at risk of obesity, heart disease, some cancers, and diabetes. The success of Internet physical activity and nutrition interventions may depend on the extent to which they lead users to develop self-efficacy for behavior change, but perhaps as important, the extent to which these interventions help them garner social-support for making changes. Success of these interventions may also depend on the extent to which they provide a platform for setting goals, planning, tracking, and providing feedback on targeted behaviors. %M 21441100 %R 10.2196/jmir.1551 %U http://www.jmir.org/2011/1/e28/ %U https://doi.org/10.2196/jmir.1551 %U http://www.ncbi.nlm.nih.gov/pubmed/21441100 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 1 %P e30 %T Supportive Accountability: A Model for Providing Human Support to Enhance Adherence to eHealth Interventions %A Mohr,David C %A Cuijpers,Pim %A Lehman,Kenneth %+ Department of Preventive Medicine, Northwestern University, 680 N Lakeshore Drive, Suite 1220, Chicago, IL, 60611, United States, d-mohr@northwestern.edu %K Internet intervention %K adherence %K computer-mediated communication %K accountability %K human support %K motivation %D 2011 %7 10.03.2011 %9 Viewpoint %J J Med Internet Res %G English %X The effectiveness of and adherence to eHealth interventions is enhanced by human support. However, human support has largely not been manualized and has usually not been guided by clear models. The objective of this paper is to develop a clear theoretical model, based on relevant empirical literature, that can guide research into human support components of eHealth interventions. A review of the literature revealed little relevant information from clinical sciences. Applicable literature was drawn primarily from organizational psychology, motivation theory, and computer-mediated communication (CMC) research. We have developed a model, referred to as “Supportive Accountability.” We argue that human support increases adherence through accountability to a coach who is seen as trustworthy, benevolent, and having expertise. Accountability should involve clear, process-oriented expectations that the patient is involved in determining. Reciprocity in the relationship, through which the patient derives clear benefits, should be explicit. The effect of accountability may be moderated by patient motivation. The more intrinsically motivated patients are, the less support they likely require. The process of support is also mediated by the communications medium (eg, telephone, instant messaging, email). Different communications media each have their own potential benefits and disadvantages. We discuss the specific components of accountability, motivation, and CMC medium in detail. The proposed model is a first step toward understanding how human support enhances adherence to eHealth interventions. Each component of the proposed model is a testable hypothesis. As we develop viable human support models, these should be manualized to facilitate dissemination. %M 21393123 %R 10.2196/jmir.1602 %U http://www.jmir.org/2011/1/e30/ %U https://doi.org/10.2196/jmir.1602 %U http://www.ncbi.nlm.nih.gov/pubmed/21393123 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 1 %P e27 %T Web-Based Guide to Health: Relationship of Theoretical Variables to Change in Physical Activity, Nutrition and Weight at 16-Months %A Anderson-Bill,Eileen Smith %A Winett,Richard A %A Wojcik,Janet R %A Winett,Sheila G %+ Center for Research in Health Behavior, Department of Psychology, Virginia Tech, Mail Code 0274, 460 Turner St. Suite 203, Blackburg, VA, 24060, United States, 1 540 231 9805, eileen@vt.edu %K Internet users %K dietary habits %K physical activity %K psychosocial aspects %K self-efficacy %K social support %K self-regulation %D 2011 %7 04.03.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Evaluation of online health interventions should investigate the function of theoretical mechanisms of behavior change in this new milieu. Objectives: To expand our understanding of how Web-based interventions influence behavior, we examined how changes at 6 months in participants’ psychosocial characteristics contributed to improvements at 16 months in nutrition, physical activity (PA), and weight management as a result of the online, social cognitive theory (SCT)-based Guide to Health intervention (WB-GTH). Methods: We conducted recruitment, enrollment, and assessments online with 272 of 655 (41.5%) participants enrolling in WB-GTH who also completed 6- and 16-month follow-up assessments. Participants’ mean age was 43.68 years, 86% were female, 92% were white, mean education was 17.45 years, median income was US $85,000, 84% were overweight or obese, and 73% were inactive. Participants received one of two equally effective versions of WB-GTH. Structural equation analysis of theoretical models evaluated whether psychosocial constructs targeted by WB-GTH contributed to observed health behavior changes. Results: The longitudinal model provided good fit to the data (root mean square error of approximation <.05). Participants’ weight loss at 16 months was predicted by improvements in their PA (betatotal = -.34, P = .01), consumption of fruits and vegetables (F&V) (betatotal = -.20, P = .03) and calorie intake (betatotal = .15, P = .04). Improvements at 6 months in PA self-efficacy (betatotal = -.10, P = .03), PA self-regulation (betatotal = -.15, P = .01), nutrition social support (betatotal = -.08, P = .03), and nutrition outcome expectations (betatotal = .08, P = .03) also contributed to weight loss. WB-GTH users with increased social support (betatotal = .26, P = .04), self-efficacy (betatotal = .30, P = .01), and self-regulation (betatotal = .45, P = .004) also exhibited improved PA levels. Decreased fat and sugar consumption followed improved social support (betatotal = -.10, P = .02), outcome expectations (betatotal = .15, P = .007), and self-regulation (betatotal = -.14, P = .008). Decreased calorie intake followed increased social support (betatotal = -.30, P < .001). Increased F&V intake followed improved self-efficacy (betatotal = .20, P = .01), outcome expectations (betatotal = -.29, P = .002), and self-regulation (betatotal = .27, P = .009). Theorized indirect effects within SCT variables were also supported. Conclusions: The WB-GTH influenced behavior and weight loss in a manner largely consistent with SCT. Improving social support, self-efficacy, outcome expectations, and self-regulation, in varying combinations, led to healthier diet and exercise habits and concomitant weight loss. High initial levels of self-efficacy may be characteristic of Web-health users interested in online interventions and may alter the function of SCT in these programs. Researchers may find that, although increased self-efficacy enhances program outcomes, participants whose self-efficacy is tempered by online interventions may still benefit. Trial Registration: Clinicaltrials.gov NCT00128570; http://clinicaltrials.gov/ct2/show/NCT00128570 (Archived by WebCite at http://www.webcitation.org/5vgcygBII) %M 21447470 %R 10.2196/jmir.1614 %U http://www.jmir.org/2011/1/e27/ %U https://doi.org/10.2196/jmir.1614 %U http://www.ncbi.nlm.nih.gov/pubmed/21447470 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 1 %P e26 %T Impact and Costs of Incentives to Reduce Attrition in Online Trials: Two Randomized Controlled Trials %A Khadjesari,Zarnie %A Murray,Elizabeth %A Kalaitzaki,Eleftheria %A White,Ian R %A McCambridge,Jim %A Thompson,Simon G %A Wallace,Paul %A Godfrey,Christine %+ E-health Unit, Research Department of Primary Care and Population Health, University College London, Royal Free Hospital, Rowland Hill Street, London, NW3 2PF, United Kingdom, 44 20 7794 0500 ext 3882, z.khadjesari@ucl.ac.uk %K Nonresponse %K attrition %K Internet %K alcohol drinking %K randomized controlled trial %D 2011 %7 02.03.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Attrition from follow-up is a major methodological challenge in randomized trials. Incentives are known to improve response rates in cross-sectional postal and online surveys, yet few studies have investigated whether they can reduce attrition from follow-up in online trials, which are particularly vulnerable to low follow-up rates. Objectives: Our objective was to determine the impact of incentives on follow-up rates in an online trial. Methods: Two randomized controlled trials were embedded in a large online trial of a Web-based intervention to reduce alcohol consumption (the Down Your Drink randomized controlled trial, DYD-RCT). Participants were those in the DYD pilot trial eligible for 3-month follow-up (study 1) and those eligible for 12-month follow-up in the DYD main trial (study 2). Participants in both studies were randomly allocated to receive an offer of an incentive or to receive no offer of an incentive. In study 1, participants in the incentive arm were randomly offered a £5 Amazon.co.uk gift voucher, a £5 charity donation to Cancer Research UK, or entry in a prize draw for £250. In study 2, participants in the incentive arm were offered a £10 Amazon.co.uk gift voucher. The primary outcome was the proportion of participants who completed follow-up questionnaires in the incentive arm(s) compared with the no incentive arm. Results: In study 1 (n = 1226), there was no significant difference in response rates between those participants offered an incentive (175/615, 29%) and those with no offer (162/611, 27%) (difference = 2%, 95% confidence interval [CI] –3% to 7%). There was no significant difference in response rates among the three different incentives offered. In study 2 (n = 2591), response rates were 9% higher in the group offered an incentive (476/1296, 37%) than in the group not offered an incentive (364/1295, 28%) (difference = 9%, 95% CI 5% to 12%, P < .001). The incremental cost per extra successful follow-up in the incentive arm was £110 in study 1 and £52 in study 2. Conclusion: Whereas an offer of a £10 Amazon.co.uk gift voucher can increase follow-up rates in online trials, an offer of a lower incentive may not. The marginal costs involved require careful consideration. Trial registration: ISRCTN31070347; http://www.controlled-trials.com/ISRCTN31070347 (Archived by WebCite at http://www.webcitation.org/5wgr5pl3s) %M 21371988 %R 10.2196/jmir.1523 %U http://www.jmir.org/2011/1/e26/ %U https://doi.org/10.2196/jmir.1523 %U http://www.ncbi.nlm.nih.gov/pubmed/21371988 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 1 %P e17 %T Online Interventions for Social Marketing Health Behavior Change Campaigns: A Meta-Analysis of Psychological Architectures and Adherence Factors %A Cugelman,Brian %A Thelwall,Mike %A Dawes,Phil %+ Statistical Cybermetrics Research Group, Wolverhampton Business School, University of Wolverhampton, Wulfruna Street, Wolverhampton, WV1 1LY, United Kingdom, 44 1902 321402, brian@alterspark.com %K Meta-analysis %K intervention studies %K behavioral medicine %K social marketing %K behavior %K psychology %K motivation %K online systems %K Internet %K Web-based services %D 2011 %7 14.02.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Researchers and practitioners have developed numerous online interventions that encourage people to reduce their drinking, increase their exercise, and better manage their weight. Motivations to develop eHealth interventions may be driven by the Internet’s reach, interactivity, cost-effectiveness, and studies that show online interventions work. However, when designing online interventions suitable for public campaigns, there are few evidence-based guidelines, taxonomies are difficult to apply, many studies lack impact data, and prior meta-analyses are not applicable to large-scale public campaigns targeting voluntary behavioral change. Objectives: This meta-analysis assessed online intervention design features in order to inform the development of online campaigns, such as those employed by social marketers, that seek to encourage voluntary health behavior change. A further objective was to increase understanding of the relationships between intervention adherence, study adherence, and behavioral outcomes. Methods: Drawing on systematic review methods, a combination of 84 query terms were used in 5 bibliographic databases with additional gray literature searches. This resulted in 1271 abstracts and papers; 31 met the inclusion criteria. In total, 29 papers describing 30 interventions were included in the primary meta-analysis, with the 2 additional studies qualifying for the adherence analysis. Using a random effects model, the first analysis estimated the overall effect size, including groupings by control conditions and time factors. The second analysis assessed the impacts of psychological design features that were coded with taxonomies from evidence-based behavioral medicine, persuasive technology, and other behavioral influence fields. These separate systems were integrated into a coding framework model called the communication-based influence components model. Finally, the third analysis assessed the relationships between intervention adherence and behavioral outcomes. Results: The overall impact of online interventions across all studies was small but statistically significant (standardized mean difference effect size d = 0.19, 95% confidence interval [CI] = 0.11 - 0.28, P < .001, number of interventions k = 30). The largest impact with a moderate level of efficacy was exerted from online interventions when compared with waitlists and placebos (d = 0.28, 95% CI = 0.17 - 0.39, P < .001, k = 18), followed by comparison with lower-tech online interventions (d = 0.16, 95% CI = 0.00 - 0.32, P = .04, k = 8); no significant difference was found when compared with sophisticated print interventions (d = –0.11, 95% CI = –0.34 to 0.12, P = .35, k = 4), though online interventions offer a small effect with the advantage of lower costs and larger reach. Time proved to be a critical factor, with shorter interventions generally achieving larger impacts and greater adherence. For psychological design, most interventions drew from the transtheoretical approach and were goal orientated, deploying numerous influence components aimed at showing users the consequences of their behavior, assisting them in reaching goals, and providing normative pressure. Inconclusive results suggest a relationship between the number of influence components and intervention efficacy. Despite one contradictory correlation, the evidence suggests that study adherence, intervention adherence, and behavioral outcomes are correlated. Conclusions: These findings demonstrate that online interventions have the capacity to influence voluntary behaviors, such as those routinely targeted by social marketing campaigns. Given the high reach and low cost of online technologies, the stage may be set for increased public health campaigns that blend interpersonal online systems with mass-media outreach. Such a combination of approaches could help individuals achieve personal goals that, at an individual level, help citizens improve the quality of their lives and at a state level, contribute to healthier societies. %M 21320854 %R 10.2196/jmir.1367 %U http://www.jmir.org/2011/1/e17/ %U https://doi.org/10.2196/jmir.1367 %U http://www.ncbi.nlm.nih.gov/pubmed/21320854 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 1 %P e9 %T Engagement in a Diabetes Self-management Website: Usage Patterns and Generalizability of Program Use %A Glasgow,Russell E %A Christiansen,Steven M %A Kurz,Deanna %A King,Diane K %A Woolley,Tim %A Faber,Andrew J %A Estabrooks,Paul A %A Strycker,Lisa %A Toobert,Deborah %A Dickman,Jennifer %+ Institute for Health Research, Kaiser Permanente, Legacy Highlands - #300, P.O. Box 378066, Denver, CO, 80237-8066, United States, 1 303 614 1362 , russg@re-aim.net %K Engagement %K Internet %K diabetes self-management %K research methods %K health disparities %D 2011 %7 25.01.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Increased access to the Internet and the availability of efficacious eHealth interventions offer great promise for assisting adults with diabetes to change and maintain health behaviors. A key concern is whether levels of engagement in Internet programs are sufficient to promote and sustain behavior change. Objective: This paper used automated data from an ongoing Internet-based diabetes self-management intervention study to calculate various indices of website engagement. The multimedia website involved goal setting, action planning, and self-monitoring as well as offering features such as “Ask an Expert” to enhance healthy eating, physical activity, and medication adherence. We also investigated participant characteristics associated with website engagement and the relationship between website use and 4-month behavioral and health outcomes. Methods: We report on participants in a randomized controlled trial (RCT) who were randomized to receive (1) the website alone (n = 137) or (2) the website plus human support (n = 133) that included additional phone calls and group meetings. The website was available in English and Spanish and included features to enhance engagement and user experience. A number of engagement variables were calculated for each participant including number of log-ins, number of website components visited at least twice, number of days entering self-monitoring data, number of visits to the “Action Plan” section, and time on the website. Key outcomes included exercise, healthy eating, and medication adherence as well as body mass index (BMI) and biological variables related to cardiovascular disease risk. Results: Of the 270 intervention participants, the average age was 60, the average BMI was 34.9 kg/m2, 130 (48%) were female, and 62 (23%) self-reported Latino ethnicity. The number of participant visits to the website over 4 months ranged from 1 to 119 (mean 28 visits, median 18). Usage decreased from 70% of participants visiting at least weekly during the first 6 weeks to 47% during weeks 7 to 16. There were no significant differences between website only and website plus support conditions on most of the engagement variables. In total, 75% of participants entered self-monitoring data at least once per week. Exercise action plan pages were visited more often than medication taking and healthy eating pages (mean of 4.3 visits vs 2.8 and 2.0 respectively, P < .001). Spearman nonparametric correlations indicated few significant associations between patient characteristics and summary website engagement variables, and key factors such as ethnicity, baseline computer use, age, health literacy, and education were not related to use. Partial correlations indicated that engagement, especially in self-monitoring, was most consistently related to improvement in healthy eating (r = .20, P = .04) and reduction of dietary fat (r = -.31, P = .001). There was also a significant correlation between self-monitoring and improvement in exercise (r = .20, P = .033) but not with medication taking. Conclusions: Participants visited the website fairly often and used all of the theoretically important sections, but engagement decreased over 4 months. Usage rates and patterns were similar for a wide range of participants, which has encouraging implications for the potential reach of online interventions. Trial Registration: NCT00987285; http://clinicaltrials.gov/show/NCT00987285 (Archived by WebCite at http://www.webcitation.org/5vpe4RHTV) %M 21371992 %R 10.2196/jmir.1391 %U http://www.jmir.org/2011/1/e9/ %U https://doi.org/10.2196/jmir.1391 %U http://www.ncbi.nlm.nih.gov/pubmed/21371992 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 1 %P e10 %T A Theory-Based Video Messaging Mobile Phone Intervention for Smoking Cessation: Randomized Controlled Trial %A Whittaker,Robyn %A Dorey,Enid %A Bramley,Dale %A Bullen,Chris %A Denny,Simon %A Elley,C Raina %A Maddison,Ralph %A McRobbie,Hayden %A Parag,Varsha %A Rodgers,Anthony %A Salmon,Penny %+ Clinical Trials Research Unit, University of Auckland, School of Population Health, Auckland, 1142, New Zealand, 1 240 314 9542, r.whittaker@ctru.auckland.ac.nz %K smoking cessation %K cellular phone %D 2011 %7 21.01.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones. This social cognitive theory-based intervention (called “STUB IT”) used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques. Objective: The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation. Methods: A randomized controlled trial was conducted with 6-month follow-up. Participants had to be 16 years of age or over, be current daily smokers, be ready to quit, and have a video message-capable phone. Recruitment targeted younger adults predominantly through radio and online advertising. Registration and data collection were completed online, prompted by text messages. The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date, role model, and timing of messages. Extra messages were available on demand to beat cravings and address lapses. The control group also set a quit date and received a general health video message sent to their phone every 2 weeks. Results: The target sample size was not achieved due to difficulty recruiting young adult quitters. Of the 226 randomized participants, 47% (107/226) were female and 24% (54/226) were Maori (indigenous population of New Zealand). Their mean age was 27 years (SD 8.7), and there was a high level of nicotine addiction. Continuous abstinence at 6 months was 26.4% (29/110) in the intervention group and 27.6% (32/116) in the control group (P = .8). Feedback from participants indicated that the support provided by the video role models was important and appreciated. Conclusions: This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone. However, there was sufficient positive feedback about the ease of use of this novel intervention, and the support obtained by observing the role model video messages, to warrant further investigation. Trial registration: Australian New Zealand Clinical Trials Registry Number: ACTRN12606000476538; http://www.anzctr.org.au/trial_view.aspx?ID=81688 (Archived by WebCite at http://www.webcitation.org/5umMU4sZi) %M 21371991 %R 10.2196/jmir.1553 %U http://www.jmir.org/2011/1/e10/ %U https://doi.org/10.2196/jmir.1553 %U http://www.ncbi.nlm.nih.gov/pubmed/21371991 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 1 %P e1 %T Patient Ability and Willingness to Participate in a Web-Based Intervention to Improve Hypertension Control %A Green,Beverly B %A Anderson,Melissa L %A Ralston,James D %A Catz,Sheryl %A Fishman,Paul A %A Cook,Andrea J %+ Group Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle, WA, 98101, United States, 1 206 287 2997, green.b@ghc.org %K electronic medical record %D 2011 %7 20.01.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: Patient-shared electronic health records provide opportunities for care outside of office visits. However, those who might benefit may be unable to or choose not to use these resources, while others might not need them. Objective: Electronic Communications and Home Blood Pressure Monitoring (e-BP) was a randomized trial that demonstrated that Web-based pharmacist care led to improved blood pressure (BP) control. During recruitment we attempted to contact all patients with hypertension from 10 clinics to determine whether they were eligible and willing to participate. We wanted to know whether particular subgroups, particularly those from vulnerable populations, were less willing to participate or unable to because they lacked computer access. Methods: From 2005 to 2006, we sent invitation letters to and attempted to recruit 9298 patients with hypertension. Eligibility to participate in the trial included access to a computer and the Internet, an email address, and uncontrolled BP (BP ≥ 140/90 mmHg). Generalized linear models within a modified Poisson regression framework were used to estimate the relative risk (RR) of ineligibility due to lack of computer access and of having uncontrolled BP. Results: We were able to contact 95.1% (8840/9298) of patients. Those refusing participation (3032/8840, 34.3%) were significantly more likely (P < .05) to be female, be nonwhite, have lower levels of education, and have Medicaid insurance. Among patients who answered survey questions, 22.8% (1673/7354) did not have computer access. Older age, minority race, and lower levels of education were risk factors for lack of computer access, with education as the strongest predictor (RR 2.63, 95% CI 2.30-3.01 for those with a high school degree compared to a college education). Among hypertensive patients with computer access who were willing to participate, African American race (RR 1.22, 95% CI 1.06-1.40), male sex (RR 1.28, 95% CI 1.18-1.38), and obesity (RR 1.53, 95% CI 1.31-1.79) were risk factors for uncontrolled BP. Conclusion: Older age, lower socioeconomic status, and lower levels of education were associated with decreased access to and willingness to participate in a Web-based intervention to improve hypertension control. Failure to ameliorate this may worsen health care disparities. Trial Registration: Clinicaltrials.gov NCT00158639; http://www.clinicaltrials.gov/ct2/show/NCT00158639 (Archived by WebCite at http://www.webcitation.org/5v1jnHaeo) %M 21371993 %R 10.2196/jmir.1625 %U http://www.jmir.org/2011/1/e1/ %U https://doi.org/10.2196/jmir.1625 %U http://www.ncbi.nlm.nih.gov/pubmed/21371993 %0 Journal Article %@ 1438-8871 %I Gunther Eysenbach %V 13 %N 1 %P e2 %T Which Intervention Characteristics are Related to More Exposure to Internet-Delivered Healthy Lifestyle Promotion Interventions? A Systematic Review %A Brouwer,Wendy %A Kroeze,Willemieke %A Crutzen,Rik %A de Nooijer,Jascha %A de Vries,Nanne K %A Brug,Johannes %A Oenema,Anke %+ Department of Public Health, Erasmus MC, University Medical Center Rotterdam, , PO Box 2040, Rotterdam, 3000 CA, Netherlands, 31 107038460, wendybrouwer73@gmail.com %K Systematic review %K Internet %K Internet intervention %K exposure %K behavior change %D 2011 %7 06.01.2011 %9 Original Paper %J J Med Internet Res %G English %X Background: The Internet has become a popular medium for the delivery of tailored healthy lifestyle promoting interventions. The actual reach of Internet-delivered interventions seems, however, lower than expected, and attrition from interventions is generally high. Characteristics of an intervention, such as personally tailored feedback and goal setting, are thought to be among the important factors related to of use of and exposure to interventions. However, there is no systematic overview of which characteristics of Internet-delivered interventions may be related to more exposure. Objective: The present study aims to identify (1) which potentially exposure-promoting methods and strategies are used in existing Internet interventions, (2) which objective outcome measures are used to measure exposure to Internet interventions, and (3) which potentially exposure-promoting methods and strategies are associated with better exposure. Methods: A systematic review of the literature was conducted based on the Cochrane guidelines. Papers published between 1995 and 2009 were searched in the PubMed, PsycINFO, and Web of Science databases. In total, 64 studies were included that reported objective exposure measures such as completion of an initial visit, number of log-ins, and time spent on the website. Information about intervention-related characteristics (ie, interactive behavior change strategies, interactive elements for fun, peer or counsel support, email/phone contact, and regular updates of the website) that could potentially contribute to better exposure and objective exposure outcomes were abstracted from the studies and qualitative systematic descriptive analyses were performed. Results: The results showed that a large variety of behavior change techniques and other exposure-promoting elements were used in the interventions and that these methods and strategies varied for the various lifestyle behaviors. Feedback, interactive elements, and email/phone contact were used most often. In addition, there was much variety and a lack of consistency in the exposure measures that were reported. Of all the categories of intervention characteristics that may be associated with better exposure, there were indications that peer and counselor support result in a longer website visit and that email/phone contact and updates of the website result in more log-ins. Conclusions: Results of this qualitative systematic review indicate that of all intervention characteristics that could potentially enhance exposure, only peer support, counselor support, email/phone contact with visitors, and updates of the intervention website were related to better exposure. The diversity of intervention methods used and the inconsistency in the report of exposure measures prevented us from drawing firmer conclusions. More research is needed to identify whether other characteristics of Internet interventions are associated with greater exposure. %M 21212045 %R 10.2196/jmir.1639 %U http://www.jmir.org/2011/1/e2/ %U https://doi.org/10.2196/jmir.1639 %U http://www.ncbi.nlm.nih.gov/pubmed/21212045